,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois 0,32343462,Early data on long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2-year update from the open-label extension of the NEURO-TTR trial.,"BACKGROUND AND PURPOSE Hereditary transthyretin (hATTR) amyloidosis causes progressive polyneuropathy resulting from transthyretin (TTR) amyloid deposition throughout the body, including the peripheral nerves. The efficacy and safety of inotersen, an antisense oligonucleotide inhibitor of TTR protein production, were demonstrated in the pivotal NEURO-TTR study in patients with hATTR polyneuropathy. Here, the long-term efficacy and safety of inotersen are assessed in an ongoing open-label extension (OLE) study. METHODS Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004). Efficacy assessments included the modified Neuropathy Impairment Score plus seven neurophysiological tests composite score (mNIS + 7), the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN) questionnaire total score and the Short-Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score. Safety and tolerability were also assessed. RESULTS Overall, 97% (135/139) of patients who completed NEURO-TTR enrolled in the OLE. Patients who received inotersen for 39 cumulative months in NEURO-TTR and the OLE continued to show benefit; patients who switched from placebo to inotersen in the OLE demonstrated improvement or stabilization of neurological disease progression by mNIS + 7, Norfolk QOL-DN and SF-36 PCS. No new safety concerns were identified. There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure. CONCLUSION Inotersen slowed disease progression and reduced deterioration of quality of life in patients with hATTR polyneuropathy. Early treatment with inotersen resulted in greater long-term disease stabilization than delayed initiation. Routine platelet and renal safety monitoring were effective; no new safety signals were observed.",2020,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure. ","['Patients With Hereditary Transthyretin Amyloidosis', 'Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004', 'patients with hATTR polyneuropathy']","['OLE', 'placebo']","['Safety and tolerability', 'risk for grade 4 thrombocytopenia or severe renal events', 'stabilization of neurologic disease progression by mNIS+7, Norfolk QOL-DN, and SF-36 PCS', 'disease progression and reduced deterioration of quality of life', 'greater long-term disease stabilization', 'modified Neuropathy Impairment Score +7 neurophysiologic tests composite score (mNIS+7), Norfolk Quality of Life-Diabetic Neuropathy questionnaire total score (Norfolk QOL-DN), and the Short Form 36 Health Survey (SF-36) Physical Component Summary score (PCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.0250599,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure. ","[{'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Wang', 'Affiliation': 'University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'CEPARM, Amyloidosis Referral Center, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Plante-Bordeneuve', 'Affiliation': 'CHU Henri Mondor, Creteil, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barroso', 'Affiliation': 'FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Amyloidosis Center, IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'CHULN, Hospital Santa Maria and Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kwoh', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Boston, MA, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Benson', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gertz', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.14285'] 1,32338944,Using intraindividual variability as an indicator of cognitive improvement in a physical exercise intervention of older women with mild cognitive impairment.,"OBJECTIVES Intervention programs designed to improve cognitive ability in older adults with mild cognitive impairment (MCI) have often focused on physical exercise as a means to improve traditional measures of cognition, with mixed success. Individuals with MCI show high levels of intraindividual variability (IIV) in response speed, and IIV may be sensitive to intervention-related changes. The current study evaluated if participants who participated in a physical activity intervention (aerobic or resistance training) showed a reduction in IIV, compared to a balance and tone control group. METHOD This study was a secondary analysis of the EXercise for Cognition and Everyday Living (EXCEL) Study. Women Aged 70-80 years with probable MCI ( n = 86) participated in a 6-month randomized controlled trial designed to investigate the effects of different physical exercises on cognitive ability. Participants completed 1-back, task switching, and spatial working memory tasks at baseline, 13 weeks (midpoint) and upon completion of the program. RESULTS Analyses were conducted following both the intent-to-treat principle and complier average casual effect (CACE) modeling. Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models. The intent-to-treat analyses were all nonsignificant. CONCLUSIONS Physical exercise resulted in improved IIV in older adults with probable MCI, showing that IIV is modifiable by lifestyle engagement. IIV may be a useful complementary index of cognitive plasticity particularly among those with cognitive impairment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models.,"['Women Aged 70-80 years with probable MCI ( n = 86', 'older women with mild cognitive impairment', 'older adults with probable MCI', 'older adults with mild cognitive impairment (MCI', 'participants who participated in a']","['physical exercise intervention', 'physical activity intervention (aerobic or resistance training', 'Physical exercise', 'physical exercises', 'balance and tone control group']","['reduced IIV on task switching', '1-back, task switching, and spatial working memory tasks', 'cognitive ability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0449234,Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Brydges', 'Affiliation': 'Department of Human Development and Family Studies.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy.'}, {'ForeName': 'Allison A M', 'Initials': 'AAM', 'LastName': 'Bielak', 'Affiliation': 'Department of Human Development and Family Studies.'}]",Neuropsychology,['10.1037/neu0000638'] 2,32339504,Long-Term Graft Patency After Off-Pump and On-Pump Coronary Artery Bypass: A CORONARY Trial Cohort.,"BACKGROUND Randomized controlled trials have compared the early and midterm prognosis of on-pump coronary artery bypass grafting (CABG) and off-pump CABG. However the results are controversial, and there is limited information on graft patency and long-term outcomes. METHODS Between May 2007 and October 2011, 349 patients were randomized to off-pump or on-pump CABG as part of the CORONARY trial at Fuwai Hospital. The primary outcome was coronary bypass graft patency, which was assessed at a mean of 6.7 ± 1.7 years after surgery by multidetector computed tomography. A secondary endpoint was a composite outcome of death, nonfatal myocardial infarction, repeat coronary revascularization, or stroke; mean follow-up was 6.5 ± 1.7 years. Graft patency was compared between the off-pump and on-pump CABG treatment arms in 206 patients with follow-up computed tomography. RESULTS During the follow-up period 107 patients were in the off-pump CABG group and 99 in the on-pump group. These patients underwent a total of 723 grafts, and the overall rate of graft patency did not differ significantly between the off-pump and on-pump groups (87.4% vs 88.9%, P = .527). The patency rate of the posterior descending branch was lower than average. Higher incidences of mortality, nonfatal myocardial infarction, and repeat revascularization were found in the off-pump patients; however it did not reach significance. CONCLUSIONS There were no statistical differences in graft patency rates in off-pump versus on-pump CABG patients during long-term follow-up. The on-pump CABG group appeared to have a better long-term prognosis even with no statistical differences for the limited study population.",2020,On-pump CABG group appeared to offer a better long-term prognosis even with no statistical differences for the limited study population.,"['Betweeen', '107 patients in the off-pump CABG group and 99 in the on-pump group during the follow-up period', '206 patients with follow-up computed tomography', 'May 2007 and October 2011, 349 patients']","['pump or on-pump CABG', 'pump coronary artery bypass grafting (CABG) and off-pump CABG', 'Pump and On-Pump Coronary Artery Bypass']","['mortality, nonfatal myocardial infarction and repeat revascularization', 'coronary bypass graft patency', 'graft patency rates', 'patency rate of the posterior descending branch', 'overall rate of graft patency', 'composite outcome of death, nonfatal myocardial infarction, repeat coronary revascularization, or stroke; mean follow-up', 'Graft patency']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",349.0,0.140282,On-pump CABG group appeared to offer a better long-term prognosis even with no statistical differences for the limited study population.,"[{'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Dachuan', 'Initials': 'D', 'LastName': 'Gu', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Sipeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. Electronic address: zhengzhe@fuwai.com.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.053'] 3,32275872,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30150-X.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30150-X'],[],[],[],[],,0.019819,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30291-7'] 4,32339910,Supporting patients and carers affected by pancreatic cancer: A feasibility study of a counselling intervention.,"PURPOSE Patients with pancreatic cancer have extremely high unmet psychological and physical needs. Family carers of these patients have even higher levels of distress than patients. Our purpose was to assess the feasibility and acceptability of a counselling intervention in patients diagnosed with pancreatic cancer and their carers. METHODS We conducted a single-arm feasibility study of the PREPARES (Patients and RElatives affected by PAncreatic cancer: Referral, Education and Support) pilot intervention. Patient and carer participants received up to nine counselling sessions delivered by a trained nurse via telephone and/or telehealth technology. The intervention, informed by self-efficacy theory, involved components to assess and address care needs, and provide feedback to clinicians. Feasibility was measured using participation and retention rates. Participants completed semi-structured interviews at the end of the intervention about acceptability. These were analysed using thematic analysis. RESULTS Twelve people participated: five patients and seven carers (38% and 50% participation rates respectively). Most participants (eight) completed all nine counselling sessions; two chose to receive fewer sessions and two were discontinued requiring more intensive psychiatric support. The intervention was highly acceptable. Participants unanimously preferred the telephone over video-conferencing and to receive counselling separately from their carer/patient. The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care. Suggested improvements included a welcome pack about their nurse-counsellor and that sessions should continue beyond nine sessions if required. CONCLUSIONS The PREPARES intervention was feasible and highly acceptable. This low-cost intervention provided much-needed support to people affected by this devastating disease.",2020,"The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care.","['patients and carers affected by pancreatic cancer', 'Patients with pancreatic cancer', 'Twelve people participated: five patients and seven carers (38% and 50% participation rates respectively', 'patients diagnosed with pancreatic cancer and their carers', 'Patients and RElatives affected by PAncreatic cancer']","['nine counselling sessions delivered by a trained nurse via telephone and/or telehealth technology', 'counselling intervention', 'telephone over video-conferencing and to receive counselling separately from their carer/patient', 'PREPARES']","['feasibility and acceptability', ""nurse-counsellors' knowledge, care coordination and personalised care""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",12.0,0.0615602,"The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care.","[{'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Beesley', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. Electronic address: Vanessa.Beesley@qimrberghofer.edu.au.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Chan', 'Affiliation': 'School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Division of Cancer Services, Princess Alexandra Hospital, Metro South Hospital and Health Services, Brisbane, Australia.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': ""School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Gordon', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burge', 'Affiliation': ""Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Eastgate', 'Affiliation': ""Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Aleksandra A', 'Initials': 'AA', 'LastName': 'Staneva', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Northfield', 'Affiliation': ""Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Beebe', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wyld', 'Affiliation': ""School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Neale', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101729'] 5,32366927,Effects of chronic type 5 phosphodiesterase inhibition on penile microvascular reactivity in hypertensive patients with erectile dysfunction: a randomized crossover placebo-controlled trial.,"This randomized crossover and placebo-controlled trial evaluated the effects of daily use of sildenafil citrate (SIL, 1-month 50 mg twice daily) on penile and systemic endothelial microvascular function in hypertensive patients presenting with erectile dysfunction. The effects of SIL on arterial pressure were evaluated using ambulatory blood pressure monitoring (ABPM). Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4 ± 5.6 years), recruited in a tertiary public hospital, were treated with SIL (50 mg twice daily) or placebo (PLA) for two 30-day periods with a 30-day washout between them. Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis was used to evaluate penile and systemic (forearm) cutaneous microvascular reactivity. SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006). The area under the curve of microvascular vasodilation induced by ACh was also significantly increased (P = 0.02). Lastly, SIL treatment did not modify systemic microvascular reactivity. Twenty-four-hour ABPM (P = 0.0002) and daytime (P = 0.002) and nighttime (P = 0.001) mean diastolic blood pressure values were significantly reduced after SIL treatment. The scores of the Simplified International Index of Erectile Function (P < 0.0001) and the number of patients with positive responses to Sexual Encounter Profile question 3 (P < 0.0001) also increased after SIL treatment. Penile endothelium-dependent microvascular reactivity improved after continuous use of sildenafil in hypertensive patients with erectile dysfunction; the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, daily use of sildenafil could improve blood pressure control.",2020,"SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006).","['hypertensive patients with erectile dysfunction', 'hypertensive patients presenting with erectile dysfunction', 'Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4\u2009±\u20095.6 years), recruited in a tertiary public hospital']","['SIL', 'Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis', 'sildenafil', 'chronic type 5 phosphodiesterase inhibition', 'sildenafil citrate (SIL, 1-month 50\u2009mg twice daily', 'placebo (PLA', 'placebo']","['penile and systemic endothelial microvascular function', 'penile microvascular reactivity', 'ambulatory blood pressure monitoring (ABPM', 'blood pressure control', 'systemic microvascular reactivity', 'area under the curve of microvascular vasodilation', 'daytime', 'mean diastolic blood pressure values', 'microvascular reactivity', 'scores of the Simplified International Index of Erectile Function', 'penile basal microvascular flow', 'penile and systemic (forearm) cutaneous microvascular reactivity', 'arterial pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}]",50.0,0.0960623,"SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006).","[{'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'Verri', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandro R', 'Initials': 'AR', 'LastName': 'Nascimento', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Brandao', 'Affiliation': 'State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Tibirica', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil. etibi@uol.com.br.'}]",Journal of human hypertension,['10.1038/s41371-020-0343-3'] 6,32341121,Dopamine and Risky Decision-Making in Gambling Disorder.,"Gambling disorder is a behavioral addiction associated with impairments in value-based decision-making and cognitive control. These functions are thought to be regulated by dopamine within fronto-striatal circuits, but the role of altered dopamine neurotransmission in the etiology of gambling disorder remains controversial. Preliminary evidence suggests that increasing frontal dopamine tone might improve cognitive functioning in gambling disorder. We therefore examined whether increasing frontal dopamine tone via a single dose of the catechol- O -methyltransferase (COMT) inhibitor tolcapone would reduce risky choice in human gamblers ( n  = 14) in a randomized double-blind placebo-controlled crossover study. Data were analyzed using hierarchical Bayesian parameter estimation and a combined risky choice drift diffusion model (DDM). Model comparison revealed a nonlinear mapping from value differences to trial-wise drift rates, confirming recent findings. An increase in risk-taking under tolcapone versus placebo was about five times more likely, given the data, than a decrease [Bayes factor (BF) = 0.2]. Examination of drug effects on diffusion model parameters revealed that an increase in the value dependency of the drift rate under tolcapone was about thirteen times more likely than a decrease (BF = 0.073). In contrast, a reduction in the maximum drift rate under tolcapone was about seven times more likely than an increase (BF = 7.51). Results add to previous work on COMT inhibitors in behavioral addictions and to mounting evidence for the applicability of diffusion models in value-based decision-making. Future work should focus on individual genetic, clinical and cognitive factors that might account for heterogeneity in the effects of COMT inhibition.",2020,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","['gambling disorder', 'human gamblers (n=14']","['catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'Dopamine', 'frontal dopamine tone via the catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'tolcapone vs. placebo', 'tolcapone', 'placebo']","['maximum drift rate under tolcapone', 'risky choice', 'value-dependency of the drift rate under tolcapone', 'cognitive functioning']","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0953733,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'Department of Psychology, Biological Psychology, University of Cologne, Cologne 50923, Germany jan.peters@uni-koeln.de.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Vega', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kayser', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}]",eNeuro,['10.1523/ENEURO.0461-19.2020'] 7,32341291,Test-Retest Reliability and the Effects of Exercise on the King-Devick Test.,"OBJECTIVE To determine the test-retest reliability and the influence of exercise on King-Devick (K-D) test performance. DESIGN Crossover study design. SETTING Controlled laboratory. PARTICIPANTS Participants consisted of 63 (39 women and 24 men) healthy, recreationally active college students who were 21.0 + 1.5 years of age. INDEPENDENT VARIABLES Participants completed the K-D test using a 2-week, test-retest interval. The K-D test was administered before and after a counterbalanced exercise or rest intervention. Reliability was assessed using testing visits (visit 1 and visit 2) as the independent variables. Exercise or rest and time (baseline, postintervention) were used as independent variables to examine the influence of exercise. MAIN OUTCOME MEASURES Intraclass correlation (ICC) coefficients with 95% confidence intervals were calculated between visits to assess reliability of K-D test completion time. A repeated-measure 2 x 2 analysis of variance (intervention × time) with post hoc paired t tests was used to assess the influence of exercise on K-D test performance. RESULTS The K-D test was observed to have strong test-retest reliability [ICC2,1 = 0.90 (0.71, 0.96)] over time. No significant intervention-by-time interaction (P = 0.55) or intervention main effects (P = 0.68) on K-D time were observed. Mean differences of -1.5 and -1.7 seconds (P < 0.001) were observed between baseline and rest and exercise interventions for K-D test performance, respectively. Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention. CONCLUSIONS Although strong test-retest reliability coefficients were observed using clinically relevant time points, a high false-positive rate warrants caution when interpreting the K-D test.",2020,"Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention. ","['Participants consisted of 63 (39 women and 24 men) healthy, recreationally active college students who were 21.0 + 1.5 years of age']",['counterbalanced exercise or rest intervention'],"['Reliability', 'Exercise or rest and time (baseline, postintervention', 'K-D time', 'false-positive K-D test performance', 'King-Devick (K-D) test performance']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C4759290', 'cui_str': 'King-Devick test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.088008,"Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention. ","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eddy', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': 'Department of Exercise Science and Athletic Training, Adrian College, Adrian, Michigan.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Resch', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000586'] 8,32341641,The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies.,"Purpose Rescue medication use is common in chronic obstructive pulmonary disease (COPD) patients and tends to increase with symptoms and disease severity. An analysis of baseline rescue medication use was conducted to inform on patient phenotypes and subsequent effects on lung function, symptoms, and safety following 12 weeks of nebulized glycopyrrolate (GLY) 25 µg twice daily or placebo in patients with moderate-to-very-severe COPD. Patients and Methods Pooled data from the 12-week, placebo-controlled GOLDEN 3 and 4 studies (n=781) were used to assign patients into quarters based on baseline rescue medication use (ie, average puffs-per-day) during the run-in period. Placebo-adjusted trough forced expiratory volume in 1 second (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) total score and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total score data were reported; safety was evaluated by reviewing the incidence of adverse events (AEs) and serious AEs (SAEs). Results Baseline rescue medication use was a proxy for disease severity, evidenced by decreased lung function, increased health status scores, symptom scores and use of background long-acting β2-agonists and inhaled corticosteroids across quarters and treatment groups. Treatment with GLY led to greater improvements from baseline in trough FEV 1 , SGRQ and EXACT-RS scores compared with placebo in all rescue medication use quarters. Additionally, the SGRQ and EXACT-RS exhibited greater improvement with increased baseline rescue medication use with GLY treatment. In the Q4 patients, SGRQ (≥4-unit reduction) or EXACT-RS (≥2-unit reduction) responders were significantly greater with GLY compared with placebo. AE and SAE incidences were similar across quartiles. Conclusion These results suggest that baseline rescue medication use assessments may be useful in the management of COPD. Treatment with nebulized GLY improved lung function and symptom scores, regardless of baseline rescue medication use. These results support the use of nebulized GLY for the treatment of COPD, independent of baseline rescue medication use.",2020,"Treatment with GLY led to greater improvements from baseline in trough FEV 1 , SGRQ and EXACT-RS scores compared with placebo in all rescue medication use quarters.","['chronic obstructive pulmonary disease\xa0(COPD) patients', 'Patients with COPD from the GOLDEN 3 and 4 Studies', 'patients with moderate-to-very-severe COPD']","['nebulized GLY', 'Placebo', 'nebulized glycopyrrolate (GLY', 'Nebulized Glycopyrrolate', 'placebo']","['Efficacy and Safety', ""trough forced expiratory volume in 1 second (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) total score and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS"", 'AE and SAE incidences', 'trough FEV 1 , SGRQ and EXACT-RS scores', 'lung function and symptom scores', 'lung function, increased health status scores, symptom scores and use of background long-acting β2-agonists and inhaled corticosteroids', 'incidence of adverse events (AEs) and serious AEs (SAEs']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",781.0,0.110616,"Treatment with GLY led to greater improvements from baseline in trough FEV 1 , SGRQ and EXACT-RS scores compared with placebo in all rescue medication use quarters.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Donohue', 'Affiliation': 'Department of Pulmonary Diseases and Critical Care Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S242767'] 9,32342266,Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants.,"PURPOSE Postoperative pain after laparoscopic surgery has 3 components: parietal, visceral, and associated with pneumoperitoneum. Visceral pain accounts for around 30% of the total pain and is less amenable to be controlled by multimodal analgesia. The topical application of vitamin E ointment has demonstrated an anti-inflammatory effect in the local inflammatory response against surgical aggression. Vitamin E has been also associated with a reduction in postoperative pain of skin wounds. The aim of this study was to evaluate the effect of the topical application of vitamin E acetate on staple lines and anastomoses of Roux-en-Y gastric bypass, as part of a multimodal analgesia scheme within an Enhanced Recovery After Surgery (ERAS) program. METHODS A prospective randomized clinical trial was performed. Patients were divided into 2 groups: patients receiving a topical application of vitamin E on staple lines and anastomoses (G1) and patients not receiving it (G2). The primary endpoint was postoperative pain, as measured by VAS 24 h after surgery. Secondary outcomes include morphine rescue needs, acute phase reactants 24 h after surgery, and hospital stay. RESULTS One hundred forty patients were included, 70 in each group. Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001). Morphine needs within the first 24 h were 2.9% in G1 and 13.2% in G2 (p = 0.026). C-reactive protein levels were significantly lower in G1 (8.7 mg/dL vs 11.9; p = 0.016). Mean hospital stay was 2.1 days in G1 and 2.9 in G2 (p = 0.019). CONCLUSION Topical application of vitamin E reduces postoperative pain and acute phase reactants, allowing an earlier discharge. TRIAL REGISTRATION NCT03765827, https://www.clinicaltrials.gov.",2020,Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001).,"['Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass', 'One hundred forty patients were included, 70 in each group']","['vitamin E acetate', 'Vitamin E Acetate', 'Morphine', 'topical application of vitamin E on staple lines and anastomoses (G1) and patients not receiving it (G2', 'vitamin E', 'vitamin E ointment', 'Vitamin E']","['staple lines and anastomoses of Roux-en-Y gastric bypass', 'morphine rescue needs, acute phase reactants 24\xa0h after surgery, and hospital stay', 'Mean hospital stay', 'Visceral pain', 'postoperative pain', 'postoperative pain and acute phase reactants', 'Postoperative Pain and Acute Phase Reactants', 'Postoperative pain', 'C-reactive protein levels']","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0078373', 'cui_str': 'Tocopherol Acetate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001347', 'cui_str': 'Acute phase reactant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",140.0,0.12876,Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001).,"[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrigni', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}]",Obesity surgery,['10.1007/s11695-020-04635-9'] 10,32341707,The Effect of Music Therapy and Aromatherapy with Chamomile-Lavender Essential Oil on the Anxiety of Clinical Nurses: A Randomized and Double-Blind Clinical Trial.,"Nurses may be anxious due to critical and emergencies, and anxiety can affect their professional performance. Non-pharmacological interventions, as a safe method, can reduce anxiety. This study aimed to determine the effect of music therapy and aromatherapy with chamomile - lavender essential oil on the anxiety of clinical nurses. This was a randomized, double-blind clinical trial. One hundred twenty nurses from clinical wards of Besat Hospital in Sanandaj, Iran, were selected between 2018 and 2019 by purposeful sampling. The samples were randomly assigned to three groups with different interventions, namely music therapy, both aromatherapy with chamomile-lavender essential oil and music therapy, and aromatherapy with chamomile-lavender essential oil, along with a control group as well. The anxiety of nurses was measured based on the Beck Anxiety Inventory before the intervention and after three work shifts. The data were analyzed using the SPSS v.22 software. One-way ANOVA was used to test the hypotheses. The findings showed that the mean scores of the anxiety of nurses after the intervention in the three groups namely the group for which music therapy was applied, the group for which aromatherapy with chamomile-lavender essential oil was used and the group for which both music therapy and aromatherapy with chamomile-lavender essential oil were applied, were (39.28), (37.82) and (40.03), respectively. Therefore, the obtained mean score of each group was significantly lower than that of the control group (56.08) (p < 0.0001). The results showed that the interventions of music therapy and aromatherapy with chamomile-lavender essential oil could reduce the anxiety of nurses. Therefore, it is recommended to use music therapy and aromatherapy with chamomile-lavender essential oil to reduce the anxiety of nurses in the clinical setting.",2020,"Therefore, the obtained mean score of each group was significantly lower than that of the control group (56.08) (p < 0.0001).","['One hundred twenty nurses from clinical wards of Besat Hospital in Sanandaj, Iran, were selected between 2018 and 2019 by purposeful sampling', 'Clinical Nurses']","['Music Therapy and Aromatherapy with Chamomile-Lavender Essential Oil', 'music therapy and aromatherapy with chamomile - lavender essential oil', 'aromatherapy with chamomile-lavender essential oil was used and the group for which both music therapy and aromatherapy with chamomile-lavender essential oil', 'namely music therapy, both aromatherapy with chamomile-lavender essential oil and music therapy, and aromatherapy with chamomile-lavender essential oil', 'music therapy and aromatherapy with chamomile-lavender essential oil']","['Beck Anxiety Inventory', 'anxiety of nurses', 'mean scores of the anxiety of nurses']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0386139,"Therefore, the obtained mean score of each group was significantly lower than that of the control group (56.08) (p < 0.0001).","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Zamanifar', 'Affiliation': 'Student Research Committee, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Mohammad Iraj', 'Initials': 'MI', 'LastName': 'Bagheri-Saveh', 'Affiliation': 'Clinical Care Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Nezakati', 'Affiliation': 'Department of Medical Surgical Nursing, Besat Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Rozhin', 'Initials': 'R', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Midwifery, Besat Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Seidi', 'Affiliation': 'Clinical Care Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}]",Journal of medicine and life,['10.25122/jml-2019-0105'] 11,32346648,"Electronic Monitoring Of Mom's Schedule (eMOMS™): Protocol for a feasibility randomized controlled trial to improve postpartum weight, blood sugars, and breastfeeding among high BMI women.","Background Overweight and obesity are major risk factors for gestational diabetes among U.S. women. Evidence suggests that longer duration of breastfeeding among women with a history of gestational diabetes is associated with lower incidence of developing type 2 diabetes after pregnancy. Women may potentially benefit from a lifestyle change program that includes breastfeeding education and support. Purpose To describe the design and justification of a combined breastfeeding, national Diabetes Prevention Program (DPP)-based feasibility randomized controlled trial, the electronic Monitoring Of Mom's Schedule (eMOMS TM ) study. eMOMS TM compares the feasibility and efficacy of three interventions on six-month postpartum weight loss among women with a BMI ≥25. Methods The intervention is delivered via Facebook and includes three groups: DPP and breastfeeding (eMOMS1); DPP only (eMOMS2); and Usual Care (eMOMS3). Recruitment is ongoing at two clinical sites (rural and urban). A total of 72 women, 24 per group, will be randomly assigned to one of the three groups. It is anticipated that women in eMOMS1 will have greater weight loss and increased length of breastfeeding at three and six months postpartum compared to women in eMOMS2 and eMOMS3. Additional data will be collected on metabolic markers, anthropometrics, physical activity, nutrition, breastfeeding, and depression. Program cost will be compared to that of traditionally scheduled group meetings. Expected study completion date: October 2021. Conclusions This study has the potential to define a high impact, cost effective intervention that can improve public health by reducing negative health outcomes associated with gestational diabetes among an at-risk population.",2020,"This study has the potential to define a high impact, cost effective intervention that can improve public health by reducing negative health outcomes associated with gestational diabetes among an at-risk population.","['women with a history of gestational diabetes', 'A total of 72 women, 24 per group', 'gestational diabetes among U.S. women', 'women with a BMI ≥25', 'high BMI women']","[""Electronic Monitoring Of Mom's Schedule (eMOMS™"", 'DPP and breastfeeding (eMOMS1); DPP only (eMOMS2); and Usual Care (eMOMS3']","['weight loss and increased length of breastfeeding', 'metabolic markers, anthropometrics, physical activity, nutrition, breastfeeding, and depression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",72.0,0.0796669,"This study has the potential to define a high impact, cost effective intervention that can improve public health by reducing negative health outcomes associated with gestational diabetes among an at-risk population.","[{'ForeName': 'Lisette T', 'Initials': 'LT', 'LastName': 'Jacobson', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Population Health, 1010 North Kansas, Wichita, KS, 67214, USA.'}, {'ForeName': 'Tracie C', 'Initials': 'TC', 'LastName': 'Collins', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Population Health, 1010 North Kansas, Wichita, KS, 67214, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Lucas', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Population Health, 1010 North Kansas, Wichita, KS, 67214, USA.'}, {'ForeName': 'Rosey', 'Initials': 'R', 'LastName': 'Zackula', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Office of Research, 1010 North Kansas, Wichita, KS, 67214, USA.'}, {'ForeName': 'Hayrettin', 'Initials': 'H', 'LastName': 'Okut', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Office of Research, 1010 North Kansas, Wichita, KS, 67214, USA.'}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': 'University of Kansas School of Medicine-Kansas City, Department of Population Health, 3901 Rainbow Boulevard, Mailstop 1003, Kansas City, KS, 66160, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robbins', 'Affiliation': 'University of Kansas Medical Center-Kansas City, Diabetes Institute, 3901 Rainbow Boulevard, Mailstop 1064, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Stern', 'Affiliation': 'Dartmouth-Hitchcock Medical Center and the Geisel School of Medicine, Department of Obstetrics and Gynecology, One Medical Center Drive, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolfe', 'Affiliation': 'Ascension Via Christi Hospitals Wichita, Inc., Ascension Via Christi Maternal Fetal Medicine Clinic, 1515 South Clifton Avenue, Suite 130, Wichita, KS, 67218, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Grainger', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Obstetrics and Gynecology, 1010 North Kansas, Wichita, KS, 67214, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100565'] 12,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE This was a preliminary investigation to investigate potential benefits of group yoga, as past work has indicated that one-on-one yoga can improve functional deficits in adults with brain injury. MATERIALS AND METHODS Participants served as their own controls. Nine participants with chronic brain injury were recruited, and seven (four female) completed the study. Performance measures of balance and mobility and self-reported measures of balance confidence, pain, and occupational performance and satisfaction were used. Data were collected 3 times: baseline (study onset), pre-yoga (after an 8-week no-contact period), and post-yoga (after 8 weeks of yoga). Group yoga was led by a yoga instructor/occupational therapist, and sessions lasted 1 h and occurred twice a week. RESULTS No participants withdrew due to adverse effects from yoga. There were no significant changes between baseline and pre-yoga. Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04). CONCLUSION We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04). ","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04). ","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172'] 13,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE The present study aimed to investigate the effect of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer. MATERIALS AND METHODS The sample consisted of 34 volunteers who were purposefully selected and then randomly divided into experimental (n = 16) and control (n = 18) groups. The research instrument included the Self-Compassion Scale and Body Image Concern Inventory. The self-healing training intervention was then performed on the experimental group for twelve 90-min sessions. Finally, both groups underwent the post-test. Follow-up was performed two and four months after the post-test. RESULTS Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05). CONCLUSION The self-healing is an appropriate intervention method to increase self-compassion and reduce body image concern and thus accelerate the process of skin cancer recovery.",2020,"RESULTS Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05). ","['patients with skin cancer', '34 volunteers who were purposefully selected']",['self-healing training'],"['level of body image concern, isolation, and over-identification', 'self-compassion, including self-kindness, self-judgment, and sense of common humanity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0885003', 'cui_str': 'Xiakucao'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}]",34.0,0.00947867,"RESULTS Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05). ","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180'] 14,32343642,"Irinotecan, Temozolomide, and Dinutuximab With GM-CSF in Children With Refractory or Relapsed Neuroblastoma: A Report From the Children's Oncology Group.","PURPOSE The combination of irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF) demonstrated activity in patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group ANBL1221 trial. To more accurately assess response rate and toxicity, an expanded cohort was nonrandomly assigned to I/T/DIN/GM-CSF. PATIENTS AND METHODS Patients were eligible at first relapse or first designation of refractory disease. Oral T and intravenous (IV) irinotecan were administered on days 1 to 5 of 21-day cycles. DIN was administered IV (days 2-5), and GM-CSF was administered subcutaneously (days 6-12). The primary end point was objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria. RESULTS Seventeen eligible patients were randomly assigned to I/T/DIN/GM-CSF (February 2013 to March 2015); 36 additional patients were nonrandomly assigned to I/T/DIN/GM-CSF (August 2016 to May 2017). Objective (complete or partial) responses were observed in nine (52.9%) of 17 randomly assigned patients (95% CI, 29.2% to 76.7%) and 13 (36.1%) of 36 expansion patients (95% CI, 20.4% to 51.8%). Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53. One-year progression-free and overall survival for all patients receiving I/T/DIN/GM-CSF were 67.9% ± 6.4% (95% CI, 55.4% to 80.5%) and 84.9% ± 4.9% (95% CI, 75.3% to 94.6%), respectively. Two patients did not receive protocol therapy and were evaluable for response but not toxicity. Common grade ≥ 3 toxicities were fever/infection (18 [35.3%] of 51), neutropenia (17 [33.3%] of 51), pain (15 [29.4%] of 51), and diarrhea (10 [19.6%] of 51). One patient met protocol-defined criteria for unacceptable toxicity (grade 4 hypoxia). Higher DIN trough levels were associated with response. CONCLUSION I/T/DIN/GM-CSF has significant antitumor activity in patients with relapsed/refractory neuroblastoma. Study of chemoimmunotherapy in the frontline setting is indicated, as is further evaluation of predictive biomarkers.",2020,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","['Seventeen eligible patients', ""patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group"", 'Patients were eligible at first relapse or first designation of refractory disease', 'Children With Refractory or Relapsed Neuroblastoma', 'patients with relapsed/refractory neuroblastoma']","['Irinotecan, Temozolomide, and Dinutuximab With GM-CSF', 'chemoimmunotherapy', 'irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF', 'Oral T and intravenous (IV) irinotecan']","['Higher DIN trough levels', 'diarrhea', 'objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria', 'neutropenia', 'response rate and toxicity', 'Objective (complete or partial) responses', 'overall survival', 'toxicity', 'fever/infection', 'stable disease', 'pain', 'antitumor activity', 'Objective responses']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0278695', 'cui_str': 'Neuroblastoma recurrent'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0930635,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","[{'ForeName': 'Rajen', 'Initials': 'R', 'LastName': 'Mody', 'Affiliation': ""C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Yu', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Fan F', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, CA.""}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Shulkin', 'Affiliation': ""St Jude Children's Research Hospital and University of Tennessee Health Science Center, Memphis, TN.""}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Sabah-E-Noor', 'Initials': 'SE', 'LastName': 'Servaes', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Mitchell B', 'Initials': 'MB', 'LastName': 'Diccianni', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Felder', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Birstler', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Asgharzadeh', 'Affiliation': ""Children's Hospital of Los Angeles and University of Southern California, Los Angeles, CA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Glade-Bender', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Katzenstein', 'Affiliation': ""Nemour's Children's Clinic, Jacksonville, FL.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Maris', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bagatell', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00203'] 15,32347887,An Exploratory Analysis of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition and Aortic Stenosis in the FOURIER Trial.,"Importance Despite recent advances in treatment of severe aortic valve stenosis (AS), AS remains a life-threatening condition with no proven disease-modifying therapy. Low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a]) have been implicated in the pathobiology of AS. The proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab reduces circulating LDL-C concentrations by 50% to 60% and Lp(a) by 20% to 30%. Objective To determine whether evolocumab reduces the risk of AS events in patients with atherosclerotic cardiovascular disease. Interventions Patients were randomized 1:1 to evolocumab or placebo. Design, Setting, and Participants Exploratory analysis of the FOURIER trial, which enrolled 27 564 patients with stable atherosclerotic cardiovascular disease who were taking statin therapy at 1242 sites in 49 countries from February 2013 to November 2016. Patients were randomized to evolocumab or placebo and followed up for a median (interquartile range) of 2.2 (1.8-2.5) years. This post hoc analysis was performed from September 2019 to February 2020. Main Outcomes and Measures Site-reported adverse events of new or worsening AS or aortic valve replacement (termed AS events). The adjusted risk of AS events was calculated with a multivariable model including concentrations of Lp(a) and LDL-C corrected for Lp(a) content, plus age, sex, diabetes, hypertension, current smoking, and estimated glomerular filtration rate. Evolocumab efficacy was tested using a Cox proportional hazards model. Results Aortic stenosis events occurred in 63 patients (48 men [76%]; mean [SD] age, 69 [9] years) over a median of 2.2 years. Elevated Lp(a) concentration was associated with higher rates of AS events (adjusted hazard ratio [aHR], 1.55 [95% CI, 1.17-2.05] per SD; P = .002), including aortic valve replacement (aHR, 2.22 [95% CI, 1.38-3.58] per SD; P = .001), after multivariable adjustment. The corrected LDL-C concentration was not significantly associated with AS events (aHR, 1.23 [95% CI, 0.93-1.61] per SD; P = .14). The overall HR for AS events with evolocumab was 0.66 (95% CI, 0.40-1.09), with no apparent association in the first year (HR, 1.09 [95% CI, 0.48-2.47]) but an HR of 0.48 (95% CI, 0.25-0.93) after the first year of treatment. Conclusions and Relevance In this exploratory analysis of the FOURIER trial, higher Lp(a) levels, but not Lp(a)-corrected LDL-C levels, were associated with a higher risk of subsequent AS events, including aortic valve replacement. Long-term therapy with evolocumab may reduce AS events, and this raises the possibility that specific pharmacologic lipid-lowering therapy could offer a means to prevent or slow the progression of AS. These exploratory findings merit further investigation with a dedicated randomized clinical trial. Trial Registration ClinicalTrials.gov Identifier: NCT01764633.",2020,"The corrected LDL-C concentration was not significantly associated with AS events (aHR, 1.23 [95% CI, 0.93-1.61] per SD; P = .14).","['September 2019 to February 2020', 'patients with atherosclerotic cardiovascular disease', 'severe aortic valve stenosis (AS', '63 patients (48 men [76', '564 patients with stable atherosclerotic cardiovascular disease who were taking statin therapy at 1242 sites in 49 countries from February 2013 to November 2016', 'mean [SD] age, 69 [9] years) over a median of 2.2 years']","['evolocumab or placebo', 'evolocumab']","['Measures\n\n\nSite-reported adverse events of new or worsening AS or aortic valve replacement (termed AS events', 'aortic valve replacement', 'circulating LDL-C concentrations', 'Evolocumab efficacy', 'corrected LDL-C concentration', 'overall HR for AS events with evolocumab', 'adjusted risk of AS events', 'Elevated Lp(a) concentration', 'Aortic stenosis events', 'concentrations of Lp(a) and LDL-C corrected for Lp(a) content, plus age, sex, diabetes, hypertension, current smoking, and estimated glomerular filtration rate', 'Low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}]",27564.0,0.256035,"The corrected LDL-C concentration was not significantly associated with AS events (aHR, 1.23 [95% CI, 0.93-1.61] per SD; P = .14).","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marat V', 'Initials': 'MV', 'LastName': 'Ezhov', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ceška', 'Affiliation': 'Third Internal Medicine Clinic, Center for Preventive Cardiology, University General Hospital, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Gouni-Berthold', 'Affiliation': 'Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Henrik K', 'Initials': 'HK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'S Lale', 'Initials': 'SL', 'LastName': 'Tokgozoglu', 'Affiliation': 'Department of Cardiology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Cardiology Division, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Cardiology and Intensive Care Medicine, Wilhelminenhospital, Third Department of Medicine, Sigmund Freud University, Medical Faculty, Vienna, Austria.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Gaciong', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Disease, the Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'The Ruth and Bruce Rappaport School of Medicine, Lady Davis Carmel Medical Center, Technion-IIT, Haifa, Israel.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Schiele', 'Affiliation': 'University Hospital Center Besançon, Besançon, France.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.0728'] 16,32347414,Predictors of Research Assessment Completion in a Latino Sample with Dual Disorders.,"Latinos are underrepresented in clinical trials, where they encounter challenges in participation and a lack of effective recruitment and retention strategies. For Latino migrants with mental health and substance use problems, these challenges are even greater. Analyzing results from a multicenter randomized clinical trial for Latino migrants with mental health and substance use problems in Boston, Massachusetts, USA as well as Madrid and Barcelona, Spain, we describe six retention strategies used to facilitate participant engagement in follow-up assessments, and report the sociodemographic, clinical, and educational factors associated with research assessment completion. Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments. Having a high school diploma, being recruited at community centers versus other sites, and having a less severe mental health condition were significantly associated with completing more follow-up interviews. Rigorous and customized methods reflecting participant's individual context can bolster research assessment completion for diverse Latino populations with behavioral health concerns.",2020,"Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments.","['Latino Sample with Dual Disorders', 'diverse Latino populations with behavioral health concerns', 'Latino migrants with mental health and substance use problems in Boston, Massachusetts, USA as well as Madrid and Barcelona, Spain']",[],['severe mental health condition'],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",341.0,0.068088,"Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments.","[{'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Herrera', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Sheri Lapatin', 'Initials': 'SL', 'LastName': 'Markle', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Aroca', 'Affiliation': 'Department of Psychiatry, Instituto de Investigación Sanitaria, Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Villar', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Dominique', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Umoren', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Alegría', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA. malegria@mgh.harvard.edu.'}]",Journal of immigrant and minority health,['10.1007/s10903-020-01010-9'] 17,32344167,Umifenovir treatment is not associated with improved outcomes in patients with coronavirus disease 2019: a retrospective study.,"OBJECTIVES Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Umifenovir (Arbidol®) is an antiviral drug being used to treat influenza in Russia and China. This study aimed to investigate the effectiveness and safety of umifenovir for COVID-19. METHODS A retrospective study was performed in a non-intensive care unit (ICU) ward in Jinyintan Hospital from 2 February 2020 to 20 March 2020. COVID-19 was confirmed by real-time reverse-transcriptase polymerase chain reaction (RT-PCR) assay of pharyngeal swab specimens. The confirmed patients were divided into the umifenovir group and the control group according to the use of umifenovir. The main outcomes were the rate of negative pharyngeal swab tests for SARS-CoV-2 within 1 week after admission and the time for the virus to turn negative. The negativity time of SARS-CoV-2 was defined as the first day of a negative test if the nucleic acid of SARS-CoV-2 was negative for two consecutive tests. RESULTS A total of 81 COVID-19 patients were included, with 45 in the umifenovir group and 36 in the control group. Baseline clinical and laboratory characteristics were comparable between the two groups. Thirty-three out of 45 (73%) patients in the umifenovir group tested negative for SARS-CoV-2 within 7 days after admission, the number was 28/36 (78%) in the control group (p 0.19). The median time from onset of symptoms to SARS-CoV-2 turning negative was 18 days (interquartile range (IQR) 12-21) in the umifenovir group and 16 days (IQR 11-21) in the control group (p 0.42). Patients in the umifenovir group had a longer hospital stay than patients in the control group (13 days (IQR 9-17) vs 11 days (IQR 9-14), p 0.04). No deaths or severe adverse reactions were found in both groups. DISCUSSION Umifenovir might not improve the prognosis or accelerate SARS-CoV-2 clearance in non-ICU patients. A randomized control clinical trial is needed to assess the efficacy of umifenovir.",2020,"CONCLUSIONS Umifenovir might not improve the prognosis or accelerate the SARS-CoV-2 clearance in non-ICU patients.","['81 COVID-19 patients were included, with 45 in umifenovir group and 36 in control group', 'non-ICU Ward in Jinyintan Hospital from February 2, 2020 to March 20, 2020', 'patients with coronavirus disease 2019']","['umifenovir', 'Umifenovir treatment', 'Umifenovir (Arbidol®']","['deaths or severe adverse reaction', 'SARS-CoV-2 clearance', 'median time from onset of symtoms to SARS-CoV-2 turning negative', ""negative rate of pharyngeal swab's test for SARS-CoV-2 within 1\xa0week after admission, as well as the duration for virus turning negative"", 'negativity time of SARS-CoV-2', 'longer hospital stay', 'SARS-CoV-2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",81.0,0.0490309,"CONCLUSIONS Umifenovir might not improve the prognosis or accelerate the SARS-CoV-2 clearance in non-ICU patients.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lian', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Liver Research Centre, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. Electronic address: linqc_fy@126.com.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.04.026'] 18,32345348,Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial.,"BACKGROUND We reported that in our previous study that wearing intermittent occlusion therapy glasses (IO-therapy) for 4 hours (h) was non-inferior to patching for 2 h in 3 to 8-year-old children with amblyopia. We hypothesize that an intense regimen of 12-h IO-therapy per day for 4 weeks could be as effective as the standard regimen of 4-h IO-therapy per day for 12 weeks in treating moderate amblyopia in 3 to 8-year-old children. METHODS/DESIGN A total of 56 children between 3 and 8 years of age with amblyopia in association with anisometropia and/or strabismus will be enrolled. All participants will be prescribed IO-therapy glasses (Amblyz™), set at 30-s opaque/transparent intervals (i.e., occluded 50% of wear time). They will be randomized to receive the standard regimen for 12 weeks or the intense regimen for 4 weeks. Adherence to using the IO-therapy glasses will be objectively monitored in each participant by means of a microsensor dose monitor. The primary study objective is to compare the effectiveness of an intense regimen to a standard regimen of IO-therapy in 3 to 8-year-old children with moderate amblyopia. The secondary study objectives are to determine whether adherence differs between an intense regimen and a standard regimen of IO-therapy, and to determine the dose-response relationship of IO-therapy. DISCUSSION In addition to testing the effectiveness, this study will test for the first time the association between treatment adherence and the visual outcome of IO-therapy, which will enhance our understanding of the dose-response relationship of IO-therapy. If an intense regimen is shown to be effective, it would alter amblyopia treatment strategies and improve visual outcomes. TRIAL REGISTRATION ClinicalTrials.gov: NCT02767856. Registered on 10 May 2016.",2020,Adherence to using the IO-therapy glasses will be objectively monitored in each participant by means of a microsensor dose monitor.,"['unilateral moderate amblyopia in children', '3\xa0to\xa08-year-old children with moderate amblyopia', 'All participants will be prescribed IO-therapy glasses (Amblyz™), set at 30-s opaque/transparent intervals (i.e., occluded 50% of wear time', '56 children between 3 and 8\u2009years of age with amblyopia in association with anisometropia and/or strabismus will be enrolled']","['intermittent occlusion therapy', 'IO-therapy']",[],"[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1444614', 'cui_str': 'Occlusion therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1444614', 'cui_str': 'Occlusion therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",[],56.0,0.0816512,Adherence to using the IO-therapy glasses will be objectively monitored in each participant by means of a microsensor dose monitor.,"[{'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA. jwang@salus.edu.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Malik', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Nemours. Alfred I. duPont Hospital of Children, Wilmington, DE, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Illinois College of Optometry, Chicago, IL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Yin', 'Affiliation': 'Illinois College of Optometry, Chicago, IL, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Illinois College of Optometry, Chicago, IL, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Grigorian', 'Affiliation': ""Arkansas Children's Hospital, Little Rock, AR, United States.""}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Scombordi', 'Affiliation': 'Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': ""St. Christopher's Hospital for Children, Philadelphia, PA, USA.""}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Aljohani', 'Affiliation': 'Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Funari', 'Affiliation': 'Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Shoge', 'Affiliation': 'Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Meiyeppen', 'Affiliation': 'Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Myung', 'Affiliation': 'Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Soni', 'Affiliation': 'Penn State Eye Center, Hershey, PA, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Neely', 'Affiliation': 'Glick Eye Institute, Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",Trials,['10.1186/s13063-020-04284-4'] 19,32345650,Using the BRAVO Risk Engine to Predict Cardiovascular Outcomes in Clinical Trials With Sodium-Glucose Transporter 2 Inhibitors.,"OBJECTIVE This study evaluated the ability of the Building, Relating, Assessing, and Validating Outcomes (BRAVO) risk engine to accurately project cardiovascular outcomes in three major clinical trials-BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME), Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction (DECLARE-TIMI 58) trial-on sodium-glucose cotransporter 2 inhibitors (SGLT2is) to treat patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Baseline data from the publications of the three trials were obtained and entered into the BRAVO model to predict cardiovascular outcomes. Projected benefits of reducing risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events were evaluated, and simulated outcomes were compared with those observed in each trial. RESULTS BRAVO achieved the best prediction accuracy when simulating outcomes of the CANVAS and DECLARE-TIMI 58 trials. For EMPA-REG OUTCOME, a mild bias was observed (∼20%) in the prediction of mortality and angina. The effect of risk reduction on outcomes in treatment versus placebo groups predicted by the BRAVO model strongly correlated with the observed effect of risk reduction on the trial outcomes as published. Finally, the BRAVO engine revealed that most of the clinical benefits associated with SGLT2i treatment are through A1C control, although reductions in SBP and BMI explain a proportion of the observed decline in cardiovascular events. CONCLUSIONS The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI. Since these benefits are individually small, the use of the complex, dynamic BRAVO model is ideal to explain the cardiovascular outcome trial results.",2020,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","['patients with type 2 diabetes', 'Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME']","['BI 10773 (Empagliflozin', 'placebo', 'sodium-glucose cotransporter 2 inhibitors (SGLT2is']","['mortality and angina', 'Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction', 'A1C, SBP, and BMI', 'risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3490349', 'cui_str': 'BI 10773'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0433696,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, Gainesville, FL.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Vivian A', 'Initials': 'VA', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA vfonseca@tulane.edu.'}]",Diabetes care,['10.2337/dc20-0227'] 20,32345653,Screening and Treatment Outcomes in Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease: The CD-DIET Study.,"OBJECTIVE To describe celiac disease (CD) screening rates and glycemic outcomes of a gluten-free diet (GFD) in patients with type 1 diabetes who are asymptomatic for CD. RESEARCH DESIGN AND METHODS Asymptomatic patients (8-45 years) were screened for CD. Biopsy-confirmed CD participants were randomized to GFD or gluten-containing diet (GCD) to assess changes in HbA 1c and continuous glucose monitoring over 12 months. RESULTS Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%, N = 1,298] vs. 4.7% [95% CI 3.4-5.9%, N = 1,089], P = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%, P < 0.0001). Fifty-one participants were randomized to a GFD ( N = 27) or GCD ( N = 24). No HbA 1c differences were seen between the groups (+0.14%, 1.5 mmol/mol; 95% CI -0.79 to 1.08; P = 0.76), although greater postprandial glucose increases (4-h +1.5 mmol/L; 95% CI 0.4-2.7; P = 0.014) emerged with a GFD. CONCLUSIONS CD is frequently observed in asymptomatic patients with type 1 diabetes, and clinical vigilance is warranted with initiation of a GFD.",2020,"RESULTS Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%, N = 1,298] vs. 4.7% [95% CI 3.4-5.9%, N = 1,089], P = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%, P < 0.0001).","['patients with type 1 diabetes who are asymptomatic for CD', 'asymptomatic patients with type 1 diabetes', 'Biopsy-confirmed CD participants', 'Asymptomatic patients (8-45 years) were screened for CD', 'Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease']","['GCD', 'GFD or gluten-containing diet (GCD', 'GFD', 'gluten-free diet (GFD']","['rates of prior CD screening', 'postprandial glucose increases', 'CD-seropositivity rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272312', 'cui_str': 'Celiac disease screen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}]",51.0,0.0463207,"RESULTS Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%, N = 1,298] vs. 4.7% [95% CI 3.4-5.9%, N = 1,089], P = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%, P < 0.0001).","[{'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada farid.mahmud@sickkids.ca.'}, {'ForeName': 'Antoine B M', 'Initials': 'ABM', 'LastName': 'Clarke', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kariym C', 'Initials': 'KC', 'LastName': 'Joachim', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Assor', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': ""Division of Endocrinology and Metabolism, St. Joseph's Health Care, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saibil', 'Affiliation': 'Division of Gastroenterology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lochnan', 'Affiliation': 'Department of Endocrinology, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Zubin', 'Initials': 'Z', 'LastName': 'Punthakee', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amish', 'Initials': 'A', 'LastName': 'Parikh', 'Affiliation': 'Division of Endocrinology, Trillium Health Partners, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Advani', 'Affiliation': ""Division of Endocrinology, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Baiju R', 'Initials': 'BR', 'LastName': 'Shah', 'Affiliation': 'Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'Division of Endocrinology and Metabolism, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Zuijdwijk', 'Affiliation': ""Division of Endocrinology and Metabolism, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mack', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Koltin', 'Affiliation': 'Division of Endocrinology, Trillium Health Partners, Toronto, Ontario, Canada.'}, {'ForeName': 'Emilia N', 'Initials': 'EN', 'LastName': 'De Melo', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Hsieh', 'Affiliation': 'Department of Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Mukerji', 'Affiliation': ""Division of Endocrinology, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bax', 'Affiliation': ""Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': ""Division of Endocrinology and Metabolism, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cino', 'Affiliation': 'Division of Gastroenterology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Beaton', 'Affiliation': 'Division of Gastroenterology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Navaaz A', 'Initials': 'NA', 'LastName': 'Saloojee', 'Affiliation': 'Department of Gastroenterology, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lou', 'Affiliation': 'JDRF, New York, NY.'}, {'ForeName': 'Patricia H', 'Initials': 'PH', 'LastName': 'Gallego', 'Affiliation': ""Division of Endocrinology, Children's Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Premysl', 'Initials': 'P', 'LastName': 'Bercik', 'Affiliation': 'Department of Gastroenterology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Houlden', 'Affiliation': 'Department of Endocrinology, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kirsch', 'Affiliation': 'Division of Endocrinology, Markham-Stouffville Hospital, Markham, Ontario, Canada.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Paterson', 'Affiliation': 'Department of Gastroenterology, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Marcon', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}]",Diabetes care,['10.2337/dc19-1944'] 21,32345747,Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD.,"BACKGROUND AND OBJECTIVES Kidney functional magnetic resonance imaging (MRI) requires further investigation to enhance the noninvasive identification of patients at high risk of CKD progression. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS In this exploratory study, we obtained baseline diffusion-weighted and blood oxygen level-dependent MRI in 122 participants of the CKD Optimal Management with Binders and Nicotinamide trial, which was a multicenter, randomized, double-blinded, 12-month, four-group parallel trial of nicotinamide and lanthanum carbonate versus placebo conducted in individuals with eGFR 20-45 ml/min per 1.73 m 2 . Lower values of apparent diffusion coefficient (ADC) on diffusion-weighted MRI may indicate increased fibrosis, and higher values of relaxation rate (R2*) on blood oxygen level-dependent MRI may represent decreased oxygenation. Because there was no effect of active treatment on eGFR over 12 months, we tested whether baseline kidney functional MRI biomarkers were associated with eGFR decline in all 122 participants. In a subset of 87 participants with 12-month follow-up MRI data, we evaluated whether kidney functional MRI biomarkers change over time. RESULTS Mean baseline eGFR was 32±9 ml/min per 1.73 m 2 , and mean annual eGFR slope was -2.3 (95% confidence interval [95% CI], -3.4 to -1.1) ml/min per 1.73 m 2 per year. After adjustment for baseline covariates, baseline ADC was associated with change in eGFR over time (difference in annual eGFR slope per 1 SD increase in ADC: 1.3 [95% CI, 0.1 to 2.5] ml/min per 1.73 m 2 per year, ADC×time interaction P =0.04). This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2 per year, ADC×time interaction P =0.08). There was no significant association between baseline R2* and change in eGFR over time. In 87 participants with follow-up functional MRI, ADC and R2* values remained stable over 12 months (intraclass correlation: 0.71 and 0.68, respectively). CONCLUSIONS Baseline cortical ADC was associated with change in eGFR over time, but this association was not independent of albuminuria. Kidney functional MRI biomarkers remained stable over 1 year. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER CKD Optimal Management with Binders and Nicotinamide (COMBINE), NCT02258074.",2020,"This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2 per year, ADC×time interaction P =0.08).","['Individuals with CKD', '122 participants of the CKD Optimal Management with Binders and Nicotinamide trial', 'conducted in individuals with eGFR 20-45 ml/min per 1.73 m 2 ', '87 participants with 12-month follow-up MRI data', 'patients at high risk of CKD progression']",['nicotinamide and lanthanum carbonate versus placebo'],"['relaxation rate', 'kidney functional MRI biomarkers change over time', 'blood oxygen level', 'baseline kidney functional MRI biomarkers', 'mean annual eGFR slope', 'Kidney functional MRI biomarkers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",87.0,0.570967,"This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2 per year, ADC×time interaction P =0.08).","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois anand.srivastava@northwestern.edu.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Jungwha', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Larive', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kendrick', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Middleton', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Renal Diseases and Hypertension, George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Michel B', 'Initials': 'MB', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Fried', 'Affiliation': 'Division of Nephrology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Dallas, Texas.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, Renal Section, University of San Diego, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Pottumarthi V', 'Initials': 'PV', 'LastName': 'Prasad', 'Affiliation': 'Department of Radiology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13201019'] 22,32348291,A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study.,"BACKGROUND Severe obesity among youths (BMI for age≥120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing evidence-based pediatric weight management program, Brenner Families in Training (Brenner FIT). However, this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment. OBJECTIVE This study aims to refine and test a tailored suite of mobile health (mHealth) components to augment an existing evidence-based pediatric weight management program. METHODS Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT]). The Brenner mFIT intervention will consist of 6 mHealth components designed to increase patient and caregiver exposure to Brenner FIT programmatic content including the following: (1) a mobile-enabled website, (2) dietary and physical activity tracking, (3) caregiver podcasts (n=12), (4) animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based on a web-based dashboard. For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures before randomization and at 3- and 6-month follow-up points. RESULTS This study was approved by the Institutional Review Board in July 2019, funded in August 2019, and will commence enrollment in April 2020. The results of the study are expected to be published in the fall/winter of 2021. CONCLUSIONS The results of this study will be used to inform a large-scale implementation-effectiveness clinical trial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/18098.",2020,"The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight-loss interventions, which highlights that a family-based treatment approach is warranted.","['July 2019, funded in August 2019, and will commence enrollment in April 2020', 'Severe obesity among the youth (BMI for age ≥120th percentile', '80 youths with obesity (aged 13-18 years) and caregiver dyads']","['established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT', 'animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based-upon a Web-based dashboard', 'Brenner FIT or Brenner mFIT']",['Physical Activity and Eating Behaviors'],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",80.0,0.0505492,"The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight-loss interventions, which highlights that a family-based treatment approach is warranted.","[{'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Dilley', 'Affiliation': 'Department of Plastic Surgery, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Camelia R', 'Initials': 'CR', 'LastName': 'Singletary', 'Affiliation': 'Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Skelton', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Vahé', 'Initials': 'V', 'LastName': 'Heboyan', 'Affiliation': 'Department of Interdisciplinary Health Sciences, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'De Leo', 'Affiliation': 'Department of Interdisciplinary Health Sciences, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education & Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McGrievy', 'Affiliation': 'Office of Operations and Accreditation, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics & Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}]",JMIR research protocols,['10.2196/18098'] 23,32348739,Limited Efficacy of Thrombolytics for Pump Thrombosis in Durable Left Ventricular Assist Devices.,"BACKGROUND This study reports a single-center experience with thrombolytics for left ventricular assist device (LVAD) pump thrombosis. METHODS Adults undergoing continuous-flow LVAD implantation between 2004 and 2018 at a single center were reviewed and those with pump thrombosis were identified. Primary outcomes included 1-year survival and success rates of thrombolytic therapy. Secondary outcomes included posttreatment adverse events, freedom from major bleeding at 1 year, and freedom from stroke at 1-year follow-up. RESULTS A total of 341 patients underwent LVAD implantation and 10.8% (n = 37) developed pump thrombosis. Of those 37, 26 received initial thrombolytic therapy (70.2%), 5 underwent direct pump exchange (13.5%), and 6 received only intravenous heparin owing to presentation with acute stroke or severe multiorgan failure (16.2%). Successful treatment was achieved in 11.5% of patients receiving thrombolytics (n = 3). Early adverse events after thrombolytic therapy included major bleeding in 11.5% (n = 3) and new stroke in 7.7% (n = 2). Most patients undergoing thrombolytic therapy underwent subsequent device exchange (69.2%; n = 18). Overall survival in patients with pump thrombosis after treatment was 96.8% at 30 days, 78.9% at 90 days, and 63.1% at 1 year. Freedom from major bleeding and stroke at 1 year was 74.2% and 87.2%, respectively. CONCLUSIONS In this single-center experience of thrombolytics for pump thrombosis in LVAD patients, there was limited efficacy; most patients required subsequent pump exchange. Combined with the risk for major bleeding or stroke with thrombolysis, this underscores the importance of further refining patient selection for direct pump exchange in those presenting with pump thrombosis.",2020,"The overall survival in patients with pump thrombosis following treatment was 96.8% at 30-days, 78.9% at 90-days, and 63.1% at 1-year.","['LVAD patients', '341 patients underwent', 'Adults undergoing continuous-flow LVAD implantation between 2004-2018 at a single center were reviewed and those with pump thrombosis identified']","['initial thrombolytic therapy', 'thrombolytic therapy', 'heparin', 'LVAD implantation']","['post-treatment adverse events, freedom from major bleeding at 1-year and freedom from stroke at 1-year follow-up', 'pump thrombosis', 'overall survival', '1-year survival and success rates of thrombolytic therapy', 'major bleeding', 'new stroke']","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}]",341.0,0.223001,"The overall survival in patients with pump thrombosis following treatment was 96.8% at 30-days, 78.9% at 90-days, and 63.1% at 1-year.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seese', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Keebler', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Floyd', 'Initials': 'F', 'LastName': 'Thoma', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: kilica2@upmc.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.061'] 24,32348985,Protocol and Baseline Data of a Multicentre Prospective Double-Blinded Randomized Study of Intravenous Iron on Functional Status in Patients with Chronic Kidney Disease.,"BACKGROUND Iron deficiency (ID) is common in patients with chronic kidney disease (CKD) due to an inadequate dietary intake of iron, poor absorption from the gut and increased iron losses. In addition to preventing anaemia, iron is important for normal heart function, being involved in processes that generate a necessary continuous energy supply. Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD. In the Iron and the Heart Study, we hypothesized that IV iron treatment will primarily improve exercise capacity and may secondarily impact the feeling of well-being in comparison to placebo over 3 months in non-anaemic CKD patients who have ID. METHODS This was a prospective double-blinded explorative randomized, multi-centre study designed to compare the effects of IV iron supplementation and placebo in iron-deficient but not anaemic patients with established CKD stages 3b-5 on functional status, and in addition cardiac structure and function. The study included 54 adults with serum ferritin (SF) <100 µg/L and/or transferrin saturation <20%, randomized in a 1:1 ratio to 1,000 mg IV ferric derisomaltose or placebo. Following randomization, participants underwent baseline assessments and then received IV iron or placebo infusion. Each participant was followed up at months 1 and 3. At each visit, patients underwent clinical review, measurements of hematinics and haemoglobin (Hb), and assessments of physical function and well-being. The primary outcome was exercise capacity using the 6-minute walk test. Secondary objectives included effects on hematinic profiles and Hb concentration, changes in myocardial parameters assessed with speckle tracking echocardiography and change in patients' quality of life. RESULTS Between October 2016 and April 2018, 55 from 326 individuals from 3 UK centres attended screening and were randomized. The mean (SD) age was 59.6 (11.7) years, 26 (48%) patients were male, the majority were Caucasians (42; 78%), and 32 (59%) were non-smokers. The mean (SD) body mass index was 30.3 (6.5); SF was 66.3 (44.1) µg/L, TS was 20.1 (7.4) % and Hb was 128.7 (10.1) g/L at randomization for the whole group. Mean (SD) serum creatinine was 186.7 (58.6) µmol/L, estimated glomerular filtration rate was 31.1 (9.6) mL/min/1.73 m2 and urinary albumin and protein/creatinine ratios 60.9 (133.3) and 83.8 (128.4) mg/mmol respectively. The mean (SD) C-reactive protein was 5.0 (4.4) mg/L and the mean (SD) 6-minute walk distance at baseline was 401.2 (120.2) m. CONCLUSION The Iron and the Heart Trial will provide important information on the short-term effects of IV iron treatment in CKD patients with ID without anaemia on measures of exercise capacity, quality of life and mechanistic data on myocardial structure and function. TRIAL REGISTRATION European Clinical Trials Database (No. 2014-004133-6; REC no. 14/YH/1209; Sponsor ref. R1766).",2020,Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD.,"['54 adults with serum ferritin (SF', 'non-anaemic CKD patients who have ID', 'patients with chronic kidney disease (CKD', 'The mean (SD) age was 59.6 (11.7) years, 26 (48', 'CKD patients with ID without anaemia', 'anaemic patients with established CKD stages 3b-5 on functional status, and in addition cardiac structure and function', 'Patients with Chronic Kidney Disease', 'Between October 2016 and April 2018, 55 from 326 individuals from 3 UK centres attended screening and were randomized', 'patients were male, the majority were Caucasians (42; 78%), and 32 (59%) were non-smokers']","['IV iron or placebo infusion', 'Intravenous Iron', 'intravenous (IV) iron', 'IV iron supplementation and placebo', 'placebo']","['exercise capacity using the 6-minute walk test', 'urinary albumin and protein/creatinine', 'exercise capacity', 'mean (SD) C-reactive protein', ""hematinic profiles and Hb concentration, changes in myocardial parameters assessed with speckle tracking echocardiography and change in patients' quality of life"", 'mean (SD) body mass index', 'glomerular filtration rate', 'Mean (SD) serum creatinine', 'mean (SD) 6-minute walk distance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0340950', 'cui_str': 'Iron deficiency without anemia'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C3839870', 'cui_str': 'Chronic kidney disease stage 3B'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0428627', 'cui_str': 'Protein/creatinine ratio measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0018928', 'cui_str': 'Hematinic'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",54.0,0.517268,Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD.,"[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom, Sunil.Bhandari@hey.nhs.uk.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'University of York, York, United Kingdom.'}, {'ForeName': 'Archie', 'Initials': 'A', 'LastName': 'Lamplugh', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.'}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Salford Royal NHS Foundation Trust, Salford, United Kingdom.'}]",American journal of nephrology,['10.1159/000507872'] 25,32349117,One-day tropisetron treatment improves cognitive deficits and P50 inhibition deficits in schizophrenia.,"The core features of schizophrenia (SCZ) include cognitive deficits and impaired sensory gating represented by P50 inhibition deficits, which appear to be related to the α7 nicotinic acetylcholine receptor (nAChR). An agonist of nAChR receptor may improve these defects. This study aimed to investigate how administering multiple doses of tropisetron, a partial agonist of nAChR, for 1 day would affect cognitive deficits and P50 inhibition deficits in SCZ patients. We randomized 40 SCZ non-smokers into a double-blind clinical trial with four groups: placebo, 5 mg/d, 10 mg/d, and 20 mg/d of oral tropisetron. Their P50 ratios were all more than 0.5 and they took risperidone at 3-6 mg/day for at least a month before participating in the experiment. We measured the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and P50 inhibition before and one day after treatment. After one day of treatment, the total RBANS scores of the 20 mg and 5 mg tropisetron groups, and the immediate memory of the 10 mg group were significantly higher than placebo group. The P50 ratio was smaller in the 5 mg and 10 mg groups than in the placebo group (both p < 0.05) after treatment. Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude. One day of treatment with tropisetron improved both cognitive and P50 inhibition deficits, suggesting that longer term treatment with α7 nAChR agonists for these deficits in SCZ may be promising.",2020,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","['schizophrenia', 'SCZ patients']","['tropisetron', 'risperidone', 'oral tropisetron', 'placebo']","['S1 latency', 'P50 ratio', 'total RBANS scores', 'cognitive and P50 inhibition deficits', 'immediate memory score', 'P50 ratios', 'Neuropsychological Status (RBANS) and P50 inhibition', 'cognitive deficits and P50 inhibition deficits', 'RBANS total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2959617', 'cui_str': 'Repeatable battery for the assessment of neuropsychological status score'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",40.0,0.0632082,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Gaoxia', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiesi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hanjing E', 'Initials': 'HE', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Xiang Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China. zhangxy@psych.ac.cn.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0685-0'] 26,32350816,Correction to: Is Open-Label Placebo a New Ergogenic Aid? A Commentary on Existing Studies and Guidelines for Future Research.,"Page 4, Figure 1.",2020,"Page 4, Figure 1.",[],[],[],[],[],[],,0.0186372,"Page 4, Figure 1.","[{'ForeName': 'Tiemi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Barreto', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil. gualano@usp.br.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-020-01289-6'] 27,32350413,Scheduling nab-paclitaxel combined with gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma.,"BACKGROUND Nab-paclitaxel plus gemcitabine (nabP+gemcitabine) offers modest survival gains for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Sequential scheduling of nabP+gemcitabine in a PDAC mouse model improved efficacy; this hypothesis was tested in a clinical trial. METHODS Patients with previously untreated metastatic PDAC were randomised to receive nabP+gemcitabine administered either concomitantly on the same day, or sequentially, with gemcitabine administered 24 h after nabP. The primary outcome measure was progression-free survival (PFS). Secondary outcome measures were objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers. RESULTS In total, 71 patients received sequential (SEQ) and 75 concomitant (CON) treatment. Six-month PFS was 46% with SEQ and 32% with CON scheduling. Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33, p = 0.70). CTCAE Grade ≥3 neutropaenia incidence doubled with SEQ therapy but was not detrimental to QoL. Strongly positive tumour epithelial cytidine deaminase (CDA) expression favoured benefit from SEQ therapy (PFS HR 0.31, 95% CI 0.13-0.70). CONCLUSIONS SEQ delivery of nabP+gemcitabine improved PFS and ORR, with manageable toxicity, but did not significantly improve OS. CLINICAL TRIAL REGISTRATION ISRCTN71070888; ClinialTrials.gov (NCT03529175).",2020,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","['Patients with previously untreated metastatic PDAC', 'metastatic pancreatic adenocarcinoma', 'patients with metastatic pancreatic ductal adenocarcinoma (PDAC']","['nabP+gemcitabine', 'sequential (SEQ) and 75 concomitant (CON) treatment', 'Scheduling nab-paclitaxel combined with gemcitabine', 'paclitaxel plus gemcitabine (nabP+gemcitabine', 'gemcitabine']","['Median PFS', 'OS', 'CTCAE Grade ≥3 neutropaenia incidence', 'objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers', 'survival gains', 'ORR', 'SEQ arm; median OS', 'efficacy', 'PFS and ORR, with manageable toxicity', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.254728,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK. pippa.corrie@addenbrookes.nhs.uk.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lwuji', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scott-Brown', 'Affiliation': 'University Hospital Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arif', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'The Royal Free Hospital, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gopinathan', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Skells', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bundi', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brais', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dalchau', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bax', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Machin', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dayim', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospitals, Truro, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospitals, Leeds, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Isherwood', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Neesse', 'Affiliation': 'Gastroenterology and Gastrointestinal Cancer Clinic, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tuveson', 'Affiliation': 'Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Jodrell', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}]",British journal of cancer,['10.1038/s41416-020-0846-2'] 28,32350598,Comparison of aspirating pipettes and hysteroscopy with curettage.,"PURPOSE In this prospective study, endometrial biopsy by pipette was compared with hysteroscopy with curettage in patients with an abnormal uterine bleeding (ABU) (hypermenorrhea, intermediate bleeding, continuous bleeding, postmenopausal bleeding) and patients with a sonographically abnormal endometrium. METHODS 176 patients were included. The pipette samples were taken during the usual planned procedure under general anaesthesia. Thereafter, the planned hysteroscopy with curettage was completed. The study was performed as a double-blind study. The obtained histologies (of pipelle and curettage) were sent separately to the same pathologist. The pipelle material was encoded by a specific number without any patient data. RESULTS In 97% of the cases using the biopsy with pipette were obtained an adequate sample. The biopsy with pipette had a sensitivity and specificity of 100% in the diagnosis of endometrial carcinoma and atypical hyperplasia. Pipette showed a significantly lower accuracy with a sensitivity of 28% in the diagnosis of endometrial hyperplasia without atypia. Pipette showed the lowest sensitivity for polyps, myomas and atrophic endometrium. CONCLUSION The study shows that pipette sampling is a safe, accurate, low-cost ambulatory procedure with high sensitivity for the detection of atypical endometrial hyperplasia and endometrial carcinoma. In the case of sonographically definable findings (polyp, myoma), hysteroscopy with curettage is preferred.",2020,"The study shows that pipette sampling is a safe, accurate, low-cost ambulatory procedure with high sensitivity for the detection of atypical endometrial hyperplasia and endometrial carcinoma.","['176 patients were included', 'patients with an abnormal uterine bleeding (ABU) (hypermenorrhea, intermediate bleeding, continuous bleeding, postmenopausal bleeding) and patients with a sonographically abnormal endometrium']","['aspirating pipettes and hysteroscopy with curettage', 'hysteroscopy with curettage']","['sensitivity and specificity', 'lowest sensitivity for polyps, myomas and atrophic endometrium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}]","[{'cui': 'C0370199', 'cui_str': 'Specimen obtained by aspiration'}, {'cui': 'C0182301', 'cui_str': 'Micropipette'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0334192', 'cui_str': 'Atrophic endometrium'}]",176.0,0.0205982,"The study shows that pipette sampling is a safe, accurate, low-cost ambulatory procedure with high sensitivity for the detection of atypical endometrial hyperplasia and endometrial carcinoma.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piriyev', 'Affiliation': 'Clinic for Gynecology and Obstetrics of the Evangelical Hospital Cologne Weyertal Academic Teaching Hospital of the University of Cologne, Cologne, Germany. piriyev.elvins@gmail.com.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Mellin', 'Affiliation': 'Practice for Pathology and Cytology Cologne Weyertal, Cologne, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Römer', 'Affiliation': 'Clinic for Gynecology and Obstetrics of the Evangelical Hospital Cologne Weyertal Academic Teaching Hospital of the University of Cologne, Cologne, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05551-0'] 29,32358262,Comparison of visual and refractive outcomes of 2 trifocal intraocular lenses.,"PURPOSE To compare clinical outcomes after cataract surgery and bilateral implantation of 2 diffractive trifocal toric intraocular lenses (IOLs). SETTING Hospital da Luz, Lisbon, Portugal. DESIGN Double-arm, randomized, prospective case series. METHODS A total of 60 patients were randomly allocated to receive bilateral implantation of either the FineVision Pod FT toric IOL (PhysIOL) or the AcrySof IQ PanOptix toric IOL (Alcon). Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire) were evaluated at 3 months postoperatively. Surgically induced astigmatic changes were evaluated by vector analysis. RESULTS Each group (FineVision toric and AcrySof IQ PanOptix toric) comprised 30 patients (60 eyes). No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333). Mean postoperative distance-corrected intermediate visual acuity at 60 cm was 0.04 ± 0.09 logarithm of the minimum angle of resolution (logMAR) and 0.09 ± 0.11 logMAR in the PanOptix and Pod FT group, respectively (P = .032). Mean IOL axis misalignment was 1.59 degrees ± 2.15 degrees (PanOptix group) and 1.89 degrees ± 3.31 degrees (Pod FT group) (P = .821). Mean magnitude of error of astigmatic correction was -0.09 diopters (D) and -0.11 D in the PanOptix group and Pod FT group, respectively (P = .333). Contrast sensitivity, QoV scores for the presence of photic phenomena, and the level of spectacle independence were similar in both groups (P > .05). CONCLUSIONS Both trifocal toric IOLs allowed complete patient visual restoration, and good spectacle independence and good visual quality outcomes. The PanOptix IOL provided superior intermediate visual acuity for distances around 60 cm.",2020,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333).,"['30 patients (60 eyes', 'Hospital da Luz, Lisbon, Portugal', '60 patients']","['2 trifocal intraocular lenses', 'cataract surgery and bilateral implantation of 2 diffractive trifocal toric intraocular lenses (IOLs', 'bilateral implantation of either the FineVision Pod FT toric IOL (PhysIOL) or the AcrySof IQ PanOptix toric IOL (Alcon']","['Mean IOL axis misalignment', 'Mean magnitude of error of astigmatic correction', 'Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire', 'corrected distance and near visual outcomes', 'Contrast sensitivity, QoV scores', 'astigmatic changes', 'Mean postoperative distance-corrected intermediate visual acuity', 'complete patient visual restoration, and good spectacle independence and good visual quality outcomes', 'level of spectacle independence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0784492,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333).,"[{'ForeName': 'Filomena J', 'Initials': 'FJ', 'LastName': 'Ribeiro', 'Affiliation': 'From the Department of Ophthalmology, Hospital da Luz, Lisbon, Portugal.'}, {'ForeName': 'Tiago B', 'Initials': 'TB', 'LastName': 'Ferreira', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000118'] 30,32349366,Site-Specific Effects of Online rTMS during a Working Memory Task in Healthy Older Adults.,"The process of manipulating information within working memory is central to many cognitive functions, but also declines rapidly in old age. Improving this process could markedly enhance the health-span in older adults. The current pre-registered, randomized and placebo-controlled study tested the potential of online repetitive transcranial magnetic stimulation (rTMS) applied at 5 Hz over the left lateral parietal cortex to enhance working memory manipulation in healthy elderly adults. rTMS was applied, while participants performed a delayed-response alphabetization task with two individually titrated levels of difficulty. Coil placement and stimulation amplitude were calculated from fMRI activation maps combined with electric field modeling on an individual-subject basis in order to standardize dosing at the targeted cortical location. Contrary to the a priori hypothesis, active rTMS significantly decreased accuracy relative to sham, and only in the hardest difficulty level. When compared to the results from our previous study, in which rTMS was applied over the left prefrontal cortex, we found equivalent effect sizes but opposite directionality suggesting a site-specific effect of rTMS. These results demonstrate engagement of cortical working memory processing using a novel TMS targeting approach, while also providing prescriptions for future studies seeking to enhance memory through rTMS.",2020,"Contrary to the a priori hypothesis, active rTMS significantly decreased accuracy relative to sham, and only in the hardest difficulty level.","['healthy elderly adults', 'Healthy Older Adults', 'older adults']","['Online rTMS', 'online repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'placebo']",['health-span'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0191049,"Contrary to the a priori hypothesis, active rTMS significantly decreased accuracy relative to sham, and only in the hardest difficulty level.","[{'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Duke University School of Medicine, 3116 N Duke Street, Durham, NC 27704, USA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Crowell', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Dannhauer', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Lim', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Hilbig', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brito', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Hile', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'National Institute of Mental Health, 6001 Executive Boulevard, Bethesda, MD 20852, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Angel V', 'Initials': 'AV', 'LastName': 'Peterchev', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cabeza', 'Affiliation': 'Center for Cognitive Neuroscience, Duke University, 308 Research Drive, Durham, NC 27710, USA.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}]",Brain sciences,['10.3390/brainsci10050255'] 31,32352828,Beyond language: Impacts of shared reading on parenting stress and early parent-child relational health.,"This study examined the interrelated and longitudinal impacts of parent-child shared book reading, parenting stress, and early relational health, as measured by both parental warmth and parent sensitivity, from infancy to toddlerhood. To extend findings from previous studies of collateral effects that have been conducted in parenting interventions, we examined parenting behaviors in a broader context to determine whether shared book reading would confer collateral benefits to the parent and parent-child relationship beyond those expected (i.e., language and literacy). It was hypothesized that positive parent-child interactions, such as shared reading, would have positive impacts on parent outcomes such as parenting stress, parental warmth, and sensitivity. The sample consisted of 293 low-income mothers and their children who participated in a randomized controlled trial. Shared book reading, parenting stress, and parental warmth were assessed when children were 6 and 18 months old. We computed a series of cross-lagged structural equation models to examine longitudinal interrelations among these three factors. Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status. These findings suggest that early parent-child book reading can have positive collateral impacts on parents' stress and the parent-child relationship over time. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status.",['293 low-income mothers and their children who participated in a randomized controlled trial'],[],"['Shared book reading, parenting stress, and parental warmth', 'parental warmth and observed sensitivity', 'parenting stress', 'parenting stress and early parent-child relational health']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0423104,"Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status.","[{'ForeName': 'Caitlin F', 'Initials': 'CF', 'LastName': 'Canfield', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Miller', 'Affiliation': 'Department of Applied Psychology.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Psychology.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Department of Pediatrics.'}]",Developmental psychology,['10.1037/dev0000940'] 32,32352832,Effects of 4-week mindfulness training versus adaptive cognitive training on processing speed and working memory in multiple sclerosis.,"OBJECTIVE The aim of this preregistered, secondary analysis of a pilot randomized controlled trial (NCT02717429) was to compare the impact of 4-week mindfulness-based training and adaptive cognitive training, with a waitlist control condition, on processing speed and working memory in people with multiple sclerosis (PwMS). METHOD Sixty-one PwMS were randomized to mindfulness-based training (MBT), adaptive computerized cognitive training (aCT), or a waitlist (WL) control group and completed the Brief Repeatable Battery of Neuropsychological Tests at pre- and posttraining. Training-related changes on the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT) were the primary outcomes of interest. Baseline cognitive status was examined as a moderator of treatment gains. Practice time, change in aCT game difficulty, and rate of change in state awareness across MBT were assessed as correlates of cognitive gains. FINDINGS Compared with aCT and WL, mindfulness training significantly improved processing speed (η p ² = .14). Baseline cognitive status did not moderate change in processing speed (η p ² = .005) or working memory (η p ² = .014). Practice time and change in game difficulty were not significantly correlated with cognitive gains (all p s > .49). In the MBT group, rate of change in awareness was significantly associated with improvement in working memory (ρ = .52, p = .04). CONCLUSIONS In PwMS, 4 weeks of mindfulness meditation training improved processing speed above and beyond aCT and WL. More rapid change in awareness during mindfulness training may be associated with greater gains in working memory. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Baseline cognitive status did not moderate change in processing speed (η p ² = .005) or working memory (η p ² = .014).,"['Sixty-one PwMS', 'people with multiple sclerosis (PwMS', 'multiple sclerosis']","['mindfulness-based training (MBT), adaptive computerized cognitive training (aCT), or a waitlist (WL) control group and completed the Brief Repeatable Battery of Neuropsychological Tests at pre- and posttraining', 'aCT and WL, mindfulness training', '4-week mindfulness training versus adaptive cognitive training', 'mindfulness meditation training', '4-week mindfulness-based training and adaptive cognitive training']","['processing speed', 'processing speed and working memory', 'Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT', 'working memory', 'Practice time and change in game difficulty', 'cognitive gains', 'Practice time, change in aCT game difficulty, and rate of change in state awareness across MBT', 'rate of change in awareness', 'processing speed above and beyond aCT and WL']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]",61.0,0.0511703,Baseline cognitive status did not moderate change in processing speed (η p ² = .005) or working memory (η p ² = .014).,"[{'ForeName': 'Heena R', 'Initials': 'HR', 'LastName': 'Manglani', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Shaadee', 'Initials': 'S', 'LastName': 'Samimy', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Schirda', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Nicholas', 'Affiliation': 'OhioHealth Multiple Sclerosis Center.'}, {'ForeName': 'Ruchika Shaurya', 'Initials': 'RS', 'LastName': 'Prakash', 'Affiliation': 'Department of Psychology.'}]",Neuropsychology,['10.1037/neu0000633'] 33,32354661,How continuum beliefs can reduce stigma of schizophrenia: The role of perceived similarities.,"Growing evidence has shown continuum beliefs as a promising tool to reduce psychiatric stigma in the general population, but data still lack regarding mechanisms underlying this effect. This study aims at testing the hypothesis that continuum beliefs affect public stigma and self-stigma by increasing perceived similarities between oneself and people with schizophrenia. Perceiving such similarities may reduce public stigma and increase self-stigma in the general population. The current study was preregistered on OSF. Data were collected via an on-line survey (N = 565). Participants were randomly assigned to one of the three experimental conditions. Continuum beliefs were induced with short videos supporting either a continuum viewpoint of schizophrenia, a categorial viewpoint of schizophrenia, or a neutral video. A scale of Perceived similarities between oneself and people with schizophrenia was administered. Public stigma was measured with an Essentialism scale and Self-stigma with a scale of self-stereotype association. Mediation analyses showed that the effects of categorial and continuum beliefs on essentialism and self-stereotype association were mediated by perceived similarities. Our results suggest that continuum beliefs about schizophrenia act as a recategorization mechanism, by enhancing perceived similarities with the stereotyped group.",2020,Mediation analyses showed that the effects of categorial and continuum beliefs on essentialism and self-stereotype association were mediated by perceived similarities.,[],[],"['essentialism and self-stereotype association', 'public stigma and increase self-stigma', 'public stigma and self-stigma', 'Public stigma', 'stigma of schizophrenia']",[],[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",565.0,0.0332623,Mediation analyses showed that the effects of categorial and continuum beliefs on essentialism and self-stereotype association were mediated by perceived similarities.,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Violeau', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France. Electronic address: louis.violeau-beaugendre@u-bordeaux.fr.'}, {'ForeName': 'Kevin-Marc', 'Initials': 'KM', 'LastName': 'Valery', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France; Adult Psychiatric Hospital of Jonzac, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fournier', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France; Adult Psychiatric Hospital of Jonzac, France.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Prouteau', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France; Adult Psychiatric Hospital of Jonzac, France.'}]",Schizophrenia research,['10.1016/j.schres.2020.04.014'] 34,32355503,"The SENIEUR protocol and the efficacy of hepatitis B vaccination in healthy elderly persons by age, gender, and vaccine route.","Background Reduced response to hepatitis B vaccines is associated with aging, confounding and comorbid conditions, as well as inadvertent subcutaneous (SC) inoculation. We hypothesized that the antibody and T cell-mediated immune responses (T-CMI) of elderly adults to a vaccine intended for intramuscular (IM) administration would be attenuated when deposited into SC fat, independent of confounding conditions. Results Fifty-two healthy, community dwelling elderly adults (65-82 years), seronegative for HBV, were enrolled in the SENIEUR protocol as a strictly healthy population. These seniors were randomized to receive a licensed alum-adjuvanted recombinant HBV vaccine either SC or IM, with the inoculum site verified by imaging. The response rates, defined as hepatitis B surface antibodies (HBsAb) ≥10 IU/L, were significantly lower in the elderly than in young adults, a group of 12, healthy, 21-34-year-old volunteers. Moreover, elderly participants who received the vaccine IM were significantly more likely to be responders than those immunized SC (54% versus 16%, p  = 0.008). The low seroconversion rate in the IM group progressively declined with increasing age, and responders had significantly lower HBsAb titers and limited isotype responses. Moreover, T-CMI (proliferation and cytokine production) were significantly reduced in both percentage of responders and intensity of the response for both Th1 and Th2 subsets in the elderly. Conclusions Our data demonstrate the blunted immunogenicity of SC inoculation as measured by peak titers and response rates. Further, the qualitative and quantitative deficits in B- and T-CMI responses to primary alum adjuvanted protein antigens persisted even in strictly healthy elderly populations with verified IM placement compared to younger populations. Clinical trial registration ClinicalTrials.gov, NCT04162223. Registered 14 November 2019. Retrospectively registered.",2020,"The response rates, defined as hepatitis B surface antibodies (HBsAb) ≥10 IU/L, were significantly lower in the elderly than in young adults, a group of 12, healthy, 21-34-year-old volunteers.","['healthy elderly persons by age, gender, and vaccine route', 'elderly adults', 'Fifty-two healthy, community dwelling elderly adults (65-82\u2009years), seronegative for HBV, were enrolled in the SENIEUR protocol as a strictly healthy population']","['vaccine IM', 'licensed alum-adjuvanted recombinant HBV vaccine either SC or IM', 'hepatitis B vaccination']","['HBsAb titers and limited isotype responses', 'peak titers and response rates', 'T-CMI (proliferation and cytokine production', 'low seroconversion rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0474232', 'cui_str': 'Hepatitis B vaccination'}]","[{'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021017', 'cui_str': 'Immunoglobulin isotype'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",,0.035921,"The response rates, defined as hepatitis B surface antibodies (HBsAb) ≥10 IU/L, were significantly lower in the elderly than in young adults, a group of 12, healthy, 21-34-year-old volunteers.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edelman', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Meagan E', 'Initials': 'ME', 'LastName': 'Deming', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Franklin R', 'Initials': 'FR', 'LastName': 'Toapanta', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Heuser', 'Affiliation': '2Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chrisley', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Barnes', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Wasserman', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Blackwelder', 'Affiliation': '6Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Handwerger', 'Affiliation': '7Rheumatology and Clinical Immunology, Dept of Medicine, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Pasetti', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Khan M', 'Initials': 'KM', 'LastName': 'Siddiqui', 'Affiliation': '10Imaging Informatics and Body Magnetic Resonance Imaging unit, Veterans Affairs Maryland Health Care System Baltimore, Baltimore, MD USA.'}, {'ForeName': 'Marcelo B', 'Initials': 'MB', 'LastName': 'Sztein', 'Affiliation': '1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}]",Immunity & ageing : I & A,['10.1186/s12979-020-00179-9'] 35,32378654,A Comparison of the Weight Loss Effect between a Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy.,"Objective Intragastric balloon (IGB) therapy is a low-invasion treatment for obesity. Recently, a low-carbohydrate diet has shown effectiveness for encouraging weight loss, but whether or not a low-carbohydrate diet improves the efficacy of IGB therapy remains unclear. Therefore, we examined the effectiveness of a low-carbohydrate diet compared with a calorie-restricted diet in combination with IGB therapy. Methods A prospective study was conducted on 51 patients who had undergone IGB therapy from October 2012 to December 2017. Overall, 31 of the 51 patients were included in this study (12-month assessment after IGB placement). These 31 cases consisted of 18 IGB plus low-carbohydrate diet and 13 IGB plus calorie-restricted diet. We compared the two groups with respect to body weight loss as outcomes. Results At 12 months after IGB placement, the body weight was significantly lower than that observed at baseline in both the IGB plus low-carbohydrate diet group (baseline 101.9±25.8 kg, 12 months 88.2±21.9 kg) (p<0.0001) and the IGB plus calorie-restricted diet group (baseline 103.5±17.0 kg, 12 months 89.1±6.2 kg) (p<0.005). The percentage of excess weight loss in the IGB plus low-carbohydrate diet group was slightly higher than that in the IGB plus calorie-restricted diet group, but there was no significant difference between the 2 groups at 12 months after IGB placement (IGB plus low-carbohydrate 49.9±60.0%, IGB plus calorie-restricted diet 33.1±27.0%). Conclusion Our study demonstrated that both a low-carbohydrate diet and a calorie-restricted diet were effective interventions for weight reduction in combination with IGB therapy.",2020,"At 12 months after IGB placement, the body weight was significantly lower than that observed at baseline in both the IGB plus low-carbohydrate diet group (baseline 101.9±25.8 kg, 12 months 88.2±21.9 kg) (p<0.0001) and the IGB plus calorie-restricted diet group (baseline 103.5±17.0 kg, 12 months 89.1±6.2 kg) (p<0.005).",['51 patients who had undergone IGB therapy from October 2012 to December 2017'],"['Objective Intragastric balloon (IGB) therapy', 'low-carbohydrate diet', 'IGB plus low-carbohydrate diet and 13 IGB plus calorie-restricted diet', 'Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy', 'calorie-restricted diet in combination with IGB therapy']","['body weight', 'percentage of excess weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",51.0,0.0136192,"At 12 months after IGB placement, the body weight was significantly lower than that observed at baseline in both the IGB plus low-carbohydrate diet group (baseline 101.9±25.8 kg, 12 months 88.2±21.9 kg) (p<0.0001) and the IGB plus calorie-restricted diet group (baseline 103.5±17.0 kg, 12 months 89.1±6.2 kg) (p<0.005).","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Maekawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Niizawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.4153-19'] 36,32353162,"Safety and pharmacokinetic profiles of MGS0274 besylate (TS-134), a novel metabotropic glutamate 2/3 receptor agonist prodrug, in healthy subjects.","AIMS The safety and pharmacokinetics of single and multiple doses of a novel mGlu 2/3 receptor agonist prodrug, MGS0274 besylate (TS-134), were investigated in healthy subjects. METHODS Phase 1 single-ascending dose (5-20 mg) and multiple-ascending dose titration (5-80 mg) studies were conducted in healthy male and female subjects. Both studies were randomized, double-blinded and placebo-controlled. In one cohort of single-ascending dose study (10 mg), concentrations of MGS0008, the active compound, in the cerebrospinal fluid (CSF) were measured for up to 24 hours postdose. RESULTS Following single and multiple oral administrations, MGS0274 was rapidly absorbed and extensively converted into MGS0008, which reached a maximum concentration (C max ) in plasma within 4 hours postdose and declined with a terminal half-life (t 1/2 ) of around 10 hours. Plasma exposure to MGS0274 was minimal, accounting for approximately 3% of the area under the concentration-time curve (AUC) of MGS0008. Plasma C max and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg). MGS0008 penetrated into CSF, with a CSF-to-plasma C max ratio of 3.66%, and was eliminated with a t 1/2 of approximately 16 hours. The most frequent treatment-emergent adverse events observed following single and multiple oral administration included headache, nausea, somnolence, dizziness and vomiting. CONCLUSION TS-134 is orally bioavailable in humans and converts rapidly and extensively to MGS0008, which exhibits good CSF penetration. Orally administered TS-134 was safe and generally well-tolerated; hence, TS-134 is a promising candidate for further clinical development for the treatment of disorders in which glutamatergic abnormalities are involved, such as schizophrenia.",2020,Plasma C max and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg).,"['healthy male and female subjects', 'healthy subjects', 'Healthy Subjects']","['TS-134', 'novel mGlu 2/3 receptor agonist prodrug, MGS0274 besylate (TS-134', 'MGS0274 Besylate (TS-134', 'single-ascending dose (SAD; 5-20 mg) and multiple-ascending dose titration (MAD', 'placebo']","['Plasma C max and AUC of MGS0008', 'maximum concentration (C max ) in plasma', 'headache, nausea, somnolence, dizziness and vomiting']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0963196', 'cui_str': 'MGS 0008'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0852044,Plasma C max and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg).,"[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Marcy', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., NJ, USA.'}, {'ForeName': 'Kohnosuke', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Fukasawa', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hikichi', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Chaki', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Okuyama', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hakop', 'Initials': 'H', 'LastName': 'Gevorkyan', 'Affiliation': 'California Clinical Trials Medical Group, CA, USA.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",British journal of clinical pharmacology,['10.1111/bcp.14331'] 37,32357128,The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial.,"BACKGROUND Telerehabilitation can facilitate multidisciplinary management for people with nonspecific chronic low back pain (NCLBP). It provides health care access to individuals who are physically and economically disadvantaged. OBJECTIVE This study aimed to evaluate the clinical and cost-effectiveness of telerehabilitation compared with a clinic-based intervention for people with NCLBP in Nigeria. METHODS A cost-utility analysis alongside a randomized controlled trial from a health care perspective was conducted. Patients with NCLBP were assigned to either telerehabilitation-based McKenzie therapy (TBMT) or clinic-based McKenzie therapy (CBMT). Interventions were carried out 3 times weekly for a period of 8 weeks. Patients' level of disability was measured using the Oswestry Disability Index (ODI) at baseline, week 4, and week 8. To estimate the health-related quality of life of the patients, the ODI was mapped to the short-form six dimensions instrument to generate quality-adjusted life years (QALYs). Health care resource use and costs were assessed based on the McKenzie extension protocol in Nigeria in 2019. Descriptive and inferential data analyses were also performed to assess the clinical effectiveness of the interventions. Bootstrapping was conducted to generate the point estimate of the incremental cost-effectiveness ratio (ICER). RESULTS A total of 47 patients (TBMT, n=21 and CBMT, n=26), with a mean age of 47 (SD 11.6) years for telerehabilitation and 50 (SD 10.7) years for the clinic-based intervention, participated in this study. The mean cost estimates of TBMT and CBMT interventions per person were 22,200 naira (US $61.7) and 38,200 naira (US $106), respectively. QALY gained was 0.085 for TBMT and 0.084 for CBMT. The TBMT arm was associated with an additional 0.001 QALY (95% CI 0.001 to 0.002) per participant compared with the CBMT arm. Thus, the ICER showed that the TBMT arm was less costly and more effective than the CBMT arm. CONCLUSIONS The findings of the study suggested that telerehabilitation for people with NCLBP was cost saving. Given the small number of participants in this study, further examination of effects and costs of the interventions is needed within a larger sample size. In addition, future studies are required to assess the cost-effectiveness of this intervention in the long term from the patient and societal perspective.",2020,The TBMT arm was associated with an additional 0.001 QALY (95% CI 0.001 to 0.002) per participant compared with the CBMT arm.,"['individuals who are physically and economically disadvantaged', 'Patients with NCLBP', 'People With Nonspecific Chronic Low Back Pain', '47 patients (TBMT, n=21 and CBMT, n=26) with a mean age of 47 (SD 11.6) years for telerehabilitation and 50 (SD 10.7) years for clinic-based intervention participated in this study', 'people with nonspecific chronic low back pain (NCLBP', 'people with NCLBP in Nigeria']","['TBMT', 'telerehabilitation compared with clinic-based intervention', 'telerehabilitation-based McKenzie therapy (TBMT) or clinic-based McKenzie therapy (CBMT']","['Oswestry Disability Index (ODI', 'level of disability', 'incremental cost-effectiveness ratio (ICER', 'mean costs estimate of TBMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",47.0,0.12828,The TBMT arm was associated with an additional 0.001 QALY (95% CI 0.001 to 0.002) per participant compared with the CBMT arm.,"[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Fatoye', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Tadesse', 'Initials': 'T', 'LastName': 'Gebrye', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fatoye', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Chidozie E', 'Initials': 'CE', 'LastName': 'Mbada', 'Affiliation': 'College of Health Sciences, Obafemi Awolowo University, Osun, Nigeria.'}, {'ForeName': 'Mistura I', 'Initials': 'MI', 'LastName': 'Olaoye', 'Affiliation': 'College of Health Sciences, Obafemi Awolowo University, Osun, Nigeria.'}, {'ForeName': 'Adesola C', 'Initials': 'AC', 'LastName': 'Odole', 'Affiliation': 'College of Medicine, University of Ibadan, Oyo, Nigeria.'}, {'ForeName': 'Olumide', 'Initials': 'O', 'LastName': 'Dada', 'Affiliation': 'College of Medicine, University of Ibadan, Oyo, Nigeria.'}]",JMIR mHealth and uHealth,['10.2196/15375'] 38,32353535,High-Definition Chromoendoscopy Superior to High-Definition White-Light Endoscopy in Surveillance of Inflammatory Bowel Diseases in a Randomized Trial.,"BACKGROUND & AIMS There is debate over the optimal method for colonoscopic surveillance of patients with inflammatory bowel diseases. Guidelines recommend chromoendoscopy, but the value of chromoendoscopy in high-definition colonoscopy has not been proven. Furthermore, the value of random biopsies is controversial. METHODS We performed a prospective study of 305 patients with ulcerative colitis or Crohn's colitis referred for surveillance colonoscopy at a university hospital in Sweden, from March 2011 through April 2016. Patients randomly assigned to a group that received high-definition chromoendoscopy with indigo carmine (HD-CE; n = 152), collection of 32 random biopsies, and targeted biopsies or polypectomies or to a group that received high-definition white light endoscopy (HD-WLE; n = 153), collection of 32 random biopsies, and targeted biopsies or polypectomies. The primary endpoint was number of patients with dysplastic lesions. RESULTS Dysplastic lesions were detected in 17 patients with HD-CE and 7 patients with HD-WLE (P = .032). Dysplasias in random biopsies (n = 9760) were detected in 9 patients: 6 (3.9%) in the HD-CE group and 3 (2.0%) in the HD-WLE group (P = .72). Of the 9 patients with dysplasia, 3 patients (33%) had primary sclerosing cholangitis-only 18% of patients (54/305) included in the study had primary sclerosing cholangitis. The number of dysplastic lesions per 10 min of withdrawal time was 0.066 with HD-CE and 0.027 with HD-WLE (P = .056). CONCLUSIONS In a randomized trial, we found HD-CE with collection of random biopsies to be superior to HD-WLE with random biopsies for detection of dysplasia per colonoscopy. These results support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases. ClinicalTrials.gov no: NCT01505842.",2020,"In a randomized trial, we found HD-CE with collection of random biopsies to be superior to HD-WLE with random biopsies for detection of dysplasia per colonoscopy.","['patients with inflammatory bowel diseases', '9 patients with dysplasia, 3 patients (33%) had primary sclerosing cholangitis-only 18% of patients (54/305) included in the study had primary sclerosing cholangitis', ""305 patients with ulcerative colitis or Crohn's colitis referred for surveillance colonoscopy at a university hospital in Sweden, from March 2011 through April 2016""]","['chromoendoscopy', 'High-definition Chromoendoscopy Superior to High-definition White-light Endoscopy', 'high-definition chromoendoscopy with indigo carmine (HD-CE, n=152), collection of 32 random biopsies, and targeted biopsies or polypectomies or to a group that received high-definition white light endoscopy (HD-WLE, n=153), collection of 32 random biopsies, and targeted biopsies or polypectomies']","['number of dysplastic lesions per 10 min of withdrawal time', 'Dysplastic lesions', 'number of patients with dysplastic lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0156147', 'cui_str': ""Crohn's disease of large bowel""}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",305.0,0.058605,"In a randomized trial, we found HD-CE with collection of random biopsies to be superior to HD-WLE with random biopsies for detection of dysplasia per colonoscopy.","[{'ForeName': 'Bjarki', 'Initials': 'B', 'LastName': 'Alexandersson', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Division of endoscopy, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Hamad', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Division of endoscopy, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Andreasson', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Division of endoscopy, Karolinska University Hospital, Stockholm, Sweden; Stress Research Institute, Stockholm University, Stockholm, Sweden; Department of Psychology, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Rubio', 'Affiliation': 'Department of Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Division of Gastroenterology and Hepatology, Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Endoscopy, Mie University Hospital, Tsu, Japan.'}, {'ForeName': 'Tamaki', 'Initials': 'T', 'LastName': 'Ichiya', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Division of endoscopy, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rezaie', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Division of endoscopy, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Schmidt', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Division of endoscopy, Karolinska University Hospital, Stockholm, Sweden. Electronic address: peter.thelin.schmidt@ki.se.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.049'] 39,32367175,Impact of a 12-Week Randomized Exercise Training Program on Lipid Profile in Severely Obese Patients Following Bariatric Surgery.,"PURPOSE The benefit of exercise training on lipid profile in bariatric surgery patients is scarce. We assess the effect of a supervised exercise-training program on lipid profile following bariatric surgery. MATERIALS AND METHODS A total of 60 patients were prospectively recruited, of those 49 completed the study (age 41 ± 11 years; body mass index 45.9 ± 6.1 kg/m 2 , 75% women). The bariatric surgery procedures performed were sleeve gastrectomy (SG) (n = 24) and biliopancreatic diversion with duodenal switch (BPD-DS) (n = 25). Of the 49 patients who completed the study, 34 had been randomized to a 12-week supervised exercise training program (exercise group) between the 3rd and the 6th month following bariatric surgery (SG = 17 and BPD-DS = 17). Fasting blood samples and anthropometric measurements were performed preoperatively and at 3, 6, and 12 months after bariatric surgery. RESULTS At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control). Both groups had an increase in HDL values between the 3nd and the 6th month following bariatric surgery. There was a significantly greater increment in HDL values in the exercise group (0.18 ± 0.14 vs. 0.07 ± 0.12 mmol/L, P = 0.014; exercise vs. control). CONCLUSION Our results showed a beneficial effect of a 12-week supervised exercise-training program in bariatric surgery patients showing similar weight loss on HDL-cholesterol levels without additional effect on LDL-cholesterol levels.",2020,"At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control).","['bariatric surgery patients', '49 patients who completed the study, 34 had been randomized to a 12-week', 'Severely Obese Patients Following Bariatric Surgery', 'A total of 60 patients were prospectively recruited, of those 49 completed the study (age 41\u2009±\u200911\xa0years; body mass index 45.9\u2009±\u20096.1\xa0kg/m 2 , 75% women']","['exercise training', 'sleeve gastrectomy (SG', 'biliopancreatic diversion with duodenal switch (BPD-DS', 'Exercise Training Program', 'supervised exercise-training program', 'supervised exercise training program (exercise']","['LDL-cholesterol levels', 'HDL values', 'Lipid Profile', 'HDL-cholesterol levels', 'percentage of weight loss', 'Fasting blood samples and anthropometric measurements']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}, {'cui': 'C1960687', 'cui_str': 'Duodenal switch'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",60.0,0.0218751,"At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Tardif', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Auclair', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Piché', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Biertho', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Marceau', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Frédéric-Simon', 'Initials': 'FS', 'LastName': 'Hould', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Biron', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Stéfane', 'Initials': 'S', 'LastName': 'Lebel', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Lescelleur', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Poirier', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada. paul.poirier@criucpq.ulaval.ca.'}]",Obesity surgery,['10.1007/s11695-020-04647-5'] 40,32359490,"Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial.","BACKGROUND In ARIEL3, rucaparib maintenance treatment significantly improved progression-free survival versus placebo. Here, we report prespecified, investigator-assessed, exploratory post-progression endpoints and updated safety data. METHODS In this ongoing (enrolment complete) randomised, placebo-controlled, phase 3 trial, patients aged 18 years or older who had platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 who had received at least two previous platinum-based chemotherapy regimens and responded to their last platinum-based regimen were randomly assigned (2:1) to oral rucaparib (600 mg twice daily) or placebo in 28-day cycles using a computer-generated sequence (block size of six with stratification based on homologous recombination repair gene mutation status, progression-free interval following penultimate platinum-based regimen, and best response to most recent platinum-based regimen). Patients, investigators, site staff, assessors, and the funder were masked to assignments. The primary endpoint of investigator-assessed progression-free survival has been previously reported. Prespecified, exploratory outcomes of chemotherapy-free interval (CFI), time to start of first subsequent therapy (TFST), time to disease progression on subsequent therapy or death (PFS2), and time to start of second subsequent therapy (TSST) and updated safety were analysed (visit cutoff Dec 31, 2017). Efficacy analyses were done in all patients randomised to three nested cohorts: patients with BRCA mutations, patients with homologous recombination deficiencies, and the intention-to-treat population. Safety analyses included all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT01968213. FINDINGS Between April 7, 2014, and July 19, 2016, 564 patients were enrolled and randomly assigned to rucaparib (n=375) or placebo (n=189). Median follow-up was 28·1 months (IQR 22·0-33·6). In the intention-to-treat population, median CFI was 14·3 months (95% CI 13·0-17·4) in the rucaparib group versus 8·8 months (8·0-10·3) in the placebo group (hazard ratio [HR] 0·43 [95% CI 0·35-0·53]; p<0·0001), median TFST was 12·4 months (11·1-15·2) versus 7·2 months (6·4-8·6; HR 0·43 [0·35-0·52]; p<0·0001), median PFS2 was 21·0 months (18·9-23·6) versus 16·5 months (15·2-18·4; HR 0·66 [0·53-0·82]; p=0·0002), and median TSST was 22·4 months (19·1-24·5) versus 17·3 months (14·9-19·4; HR 0·68 [0·54-0·85]; p=0·0007). CFI, TFST, PFS2, and TSST were also significantly longer with rucaparib than placebo in the BRCA-mutant and homologous recombination-deficient cohorts. The most frequent treatment-emergent adverse event of grade 3 or higher was anaemia or decreased haemoglobin (80 [22%] patients in the rucaparib group vs one [1%] patient in the placebo group). Serious treatment-emergent adverse events were reported in 83 (22%) patients in the rucaparib group and 20 (11%) patients in the placebo group. Two treatment-related deaths have been previously reported in this trial; there were no new treatment-related deaths. INTERPRETATION In these exploratory analyses over a median follow-up of more than 2 years, rucaparib maintenance treatment led to a clinically meaningful delay in starting subsequent therapy and provided lasting clinical benefits versus placebo in all three analysis cohorts. Updated safety data were consistent with previous reports. FUNDING Clovis Oncology.",2020,"CFI, TFST, PFS2, and TSST were also significantly longer with rucaparib than placebo in the BRCA-mutant and homologous recombination-deficient cohorts.","['0·54-0·85', 'patients randomised to three nested cohorts: patients with BRCA mutations, patients with homologous recombination deficiencies, and the intention-to-treat population', 'Between April 7, 2014, and July 19, 2016, 564 patients', 'patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3', 'patients who received at least one dose of study treatment', 'patients aged 18 years or older who had platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 who had received at least two previous platinum-based chemotherapy regimens and responded to their last platinum-based regimen']","['rucaparib', 'oral rucaparib', 'Rucaparib', 'placebo in 28-day cycles using a computer-generated sequence (block size of six with stratification based on homologous recombination repair gene mutation status, progression-free interval following penultimate platinum-based regimen', 'placebo']","['median PFS2', 'progression-free survival', 'CFI, TFST, PFS2, and TSST', 'median CFI', 'investigator-assessed progression-free survival', 'Serious treatment-emergent adverse events', 'anaemia or decreased haemoglobin', 'chemotherapy-free interval (CFI), time to start of first subsequent therapy (TFST), time to disease progression on subsequent therapy or death (PFS2), and time to start of second subsequent therapy (TSST) and updated safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",564.0,0.619906,"CFI, TFST, PFS2, and TSST were also significantly longer with rucaparib than placebo in the BRCA-mutant and homologous recombination-deficient cohorts.","[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Department of Oncology, UCL Cancer Institute, University College London and UCL Hospitals, London, UK. Electronic address: j.ledermann@ucl.ac.uk.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Gynecologic Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Gynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Oncology,St John of God Subiaco Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Division of Gynecologic Oncology, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Gynecologic Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gynecological Unit, Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'Gynecologic Oncology, AdventHealth Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Medical Oncology Department, Oncology Center of Galicia, La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Medical Oncology Department, Auckland City Hospital, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Department of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Faculty of Medicine, University of Queensland, St Lucia, QLD, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Gynaecology Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'Division of Medical Oncology, HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clinical Science, Clovis Oncology UK, Cambridge, UK.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clinical Development, Clovis Oncology, Boulder, CO, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Biostatistics, Clovis Oncology, Boulder, CO, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30061-9'] 41,32359506,"Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation. METHODS In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m 2 administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m 2 administered orally on days 1-4) and prednisone (60 mg/m 2 administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m 2 ), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m 2 either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment. FINDINGS Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2-67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3-64·5] vs 41·9 months [37·5-46·9]; hazard ratio [HR] 0·73, 0·62-0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3-49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0-not estimable] vs 45·5 months [39·5-58·4]; HR 0·77, 0·63-0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]). INTERPRETATION This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone. FUNDING Janssen and Celgene.",2020,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"['untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network', 'Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein', 'patients with newly diagnosed multiple myeloma', '1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428', '1503 patients were enrolled', 'patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus', 'All patients who received at least one dose of study drugs were included in the safety analyses', 'Between Feb 25, 2011, and April 3, 2014', 'newly diagnosed multiple myeloma (EMN02/HO95']","['VMP or single or double HSCT', 'prednisone', 'autologous HSCT after high-dose melphalan', 'lenalidomide', 'dexamethasone', 'bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy', 'melphalan', 'consolidation therapy with bortezomib', 'lenalidomide maintenance therapy', 'autologous HSCT', 'VMP', 'bortezomib', 'L or urine M protein', 'Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy', 'autologous haematopoietic stem-cell transplantation (HSCT', 'autologous HSCT with bortezomib-melphalan-prednisone (VMP']","['median progression-free survival', 'neutropenia', 'progression-free survival', 'number of events of progression or death at data cutoff', 'gastrointestinal disorders', 'cardiac events', 'serious adverse event', 'thrombocytopenia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",1503.0,0.203417,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy. Electronic address: michele.cavo@unibo.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gay', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pantani', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dozza', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Department of Trials and Statistics-HOVON Data Centre, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Oliva', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Vincent H J', 'Initials': 'VHJ', 'LastName': 'van der Velden', 'Affiliation': 'Department of Immunology, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zamagni', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Palumbo', 'Affiliation': 'Dipartimento di Science Mediche Chirurgiche e Tecnologie Avanzate ""GF Ingrassia"", Università degli Studi di Catania, Catania, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'Clinical Hematology and Bone Marrow Transplant Centre, S Maria della Misericordia University Hospital, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Hematology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, ASST-Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maisnar', 'Affiliation': '4th Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gamberi', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Belotti', 'Affiliation': 'SC Ematologia e Dipartimento di Oncologia Clinica, AO Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'SC Ematologia, Azienda Ospedaliera S Croce-Carle, Cuneo, Italy.'}, {'ForeName': 'Alexsandra', 'Initials': 'A', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': 'Reparto di Ematologia con TMO, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Iolanda D', 'Initials': 'ID', 'LastName': 'Vincelli', 'Affiliation': 'Division of Haematology, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Hematology, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Faculty of Medicine, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Niels Frost', 'Initials': 'NF', 'LastName': 'Andersen', 'Affiliation': 'Department of Haematology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Troia', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pascarella', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo, Mestre, Venice, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Benevolo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Haematology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': 'Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Morelli', 'Affiliation': 'Clinical Hematology, Department of Hematology, Transfusion Medicine and Biotechnology, ""Spirito Santo"" Civic Hospital, Pescara, Italy.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Internal Medicine, Amphia Hospital Breda, Breda, Netherlands.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'von dem Borne', 'Affiliation': 'Department of Hematology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Caravita di Toritto', 'Affiliation': 'UOSD Ematologia ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'Department Oncology/Hematology, Kantonsspital, Lucerne, Switzerland.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Hematology, University Aldo Moro, Bari, Italy.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Hematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gimsing', 'Affiliation': 'Department of Haematology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Department of Medicine, Section of Hematology and Coagulation, South Elvsborg Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Kliniek, Zwolle, Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht, University Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mandigers', 'Affiliation': 'Department of Hematology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cafro', 'Affiliation': 'Department of Hematology, ASST Grande Ospedale Metropolitano, Niguarda, Milan, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Palmas', 'Affiliation': 'Haematology, Ospedale San Francesco, Nuoro, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Português de Oncologia de Lisboa Francisco Gentil, IPOLFG, Lisbon, Portugal.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Haematology, Alfred Hospital-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30099-5'] 42,32366280,The role of baseline BLyS levels and type 1 interferon-inducible gene signature status in determining belimumab response in systemic lupus erythematosus: a post hoc meta-analysis.,"BACKGROUND Elevated B lymphocyte stimulator (BLyS) levels in patients with systemic lupus erythematosus (SLE) correlate positively with disease activity; BLyS expression is directly linked to interferon (IFN) pathway activation. This post hoc meta-analysis of BLISS-52 and BLISS-76 explored the relationship between baseline BLyS mRNA/protein levels and/or type 1 IFN-inducible gene signature (IFN-1) and responses to the BLyS-targeting monoclonal antibody belimumab in SLE. METHODS In BLISS-52 and BLISS-76, patients with autoantibody-positive SLE and a SELENA-SLEDAI score ≥ 6 and receiving stable standard SLE therapy were randomised to intravenous belimumab 10 mg/kg or placebo, plus standard of care (SoC), for 52 or 76 weeks. For this post hoc meta-analysis, patients with an appropriate mRNA sample were stratified by BLyS mRNA expression (tertiles: high/medium/low; revised quantiles: high/low), IFN-1 mRNA expression (high/low) and BLyS protein level (high/low). Co-primary endpoints were correlation between baseline BLyS and IFN-1 mRNA levels and SLE Responder Index (SRI)4 response at week 52 within BLyS/IFN-1 subgroups. Secondary endpoints included time to first severe SELENA-SLEDAI Flare Index (SFI) flare. RESULTS Of 554 patients included in this analysis, 281 had received belimumab and 273 had received placebo. Baseline BLyS and IFN-1 mRNA levels were highly correlated (Spearman's rank correlation coefficient 0.7799; 95% confidence interval [CI] 0.7451, 0.8106; p < 0.0001). The proportion of SRI4 responders was higher with belimumab versus placebo in all subgroups, but the difference reached statistical significance in the medium BLyS mRNA tertile (odds ratio [OR] 2.17; 95% CI 1.16, 4.04; p = 0.0153), high BLyS mRNA quantile (OR 1.58; 95% CI 1.02, 2.44; p = 0.0402), high IFN-1 mRNA (OR 1.58; 95% CI: 1.08, 2.31; p = 0.0186) and high BLyS protein (OR 3.57; 95% CI 1.63, 7.83; p = 0.0015) subgroups only. The risk of severe SFI flare was significantly lower with belimumab than placebo in the high BLyS mRNA quantile (hazard ratio [HR] 0.59; 95% CI 0.36, 0.97; p = 0.0371) and high BLyS protein (HR 0.39; 95% CI 0.19, 0.79; p = 0.0090) subgroups. CONCLUSIONS This post hoc meta-analysis demonstrated a tendency towards improved response to add-on intravenous belimumab 10 mg/kg versus SoC alone in patients with high baseline BLyS protein and IFN-1 mRNA levels and medium/high BLyS mRNA levels.",2020,"The risk of severe SFI flare was significantly lower with belimumab than placebo in the high BLyS mRNA quantile (hazard ratio [HR] 0.59; 95% CI 0.36, 0.97; p = 0.0371) and high BLyS protein (HR 0.39; 95% CI 0.19, 0.79; p = 0.0090) subgroups. ","['patients with systemic lupus erythematosus (SLE', 'systemic lupus erythematosus', 'patients with autoantibody-positive SLE and a SELENA-SLEDAI score\u2009≥\u20096 and receiving stable standard SLE therapy', '554 patients included in this analysis']","['interferon-inducible gene signature status', 'intravenous belimumab 10\u2009mg/kg or placebo, plus standard of care (SoC', 'belimumab', 'placebo']","['baseline BLyS and IFN-1 mRNA levels and SLE Responder Index (SRI)4 response', 'time to first severe SELENA-SLEDAI Flare Index (SFI) flare', 'high BLyS protein', 'Baseline BLyS and IFN-1 mRNA levels', 'high IFN-1 mRNA', 'risk of severe SFI flare', 'high BLyS mRNA quantile', 'proportion of SRI4 responders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0853878', 'cui_str': 'Autoantibody positive'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0767393', 'cui_str': 'TALL-1 Protein'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",554.0,0.27505,"The risk of severe SFI flare was significantly lower with belimumab than placebo in the high BLyS mRNA quantile (hazard ratio [HR] 0.59; 95% CI 0.36, 0.97; p = 0.0371) and high BLyS protein (HR 0.39; 95% CI 0.19, 0.79; p = 0.0090) subgroups. ","[{'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Wilkinson', 'Affiliation': 'GSK, Stevenage, Herts, UK.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Henderson', 'Affiliation': 'GSK, Stevenage, Herts, UK.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Jones-Leone', 'Affiliation': 'GSK, Upper Providence, PA, USA.'}, {'ForeName': 'Shaun M', 'Initials': 'SM', 'LastName': 'Flint', 'Affiliation': 'GSK, Stevenage, Herts, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lennon', 'Affiliation': 'GSK, Stevenage, Herts, UK.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Levy', 'Affiliation': 'GSK, Upper Providence, PA, USA. roger.x.levy@gsk.com.'}, {'ForeName': 'Beulah', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': 'GSK, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Damon L', 'Initials': 'DL', 'LastName': 'Bass', 'Affiliation': 'GSK, Philadelphia, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'GSK, Philadelphia, PA, USA.'}]",Arthritis research & therapy,['10.1186/s13075-020-02177-0'] 43,32353592,A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein.,"OBJECTIVE The quality of available evidence regarding new minimally invasive techniques to abolish great saphenous vein reflux is moderate. The present study assessed whether radiofrequency ablation (RFA) was noninferior to high ligation and stripping (HLS) and conservative hemodynamic cure for venous insufficiency (CHIVA) for clinical and ultrasound recurrence at 2 years in patients with primary varicose veins (VVs) due to great saphenous vein (GSV) insufficiency. METHODS We performed a randomized, single-center, open-label, controlled, noninferiority trial to compare RFA and 2 surgical techniques for the treatment of primary VVs due to GSV insufficiency. The noninferiority margin was set at 15% for absolute differences. Patients aged >18 years with primary VVs and GSV incompetence, with or without clinical symptoms, C2 to C6 CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) clinical class, and GSV diameter >4 mm were randomized with a 1:1:1 ratio to RFA, HLS, or CHIVA. The rate of clinical recurrence at 24 months was the primary endpoint and was analyzed using a delta noninferiority margin of 15%. Ultrasound recurrence, safety, and quality of life were secondary endpoints. RESULTS From December 2012 to June 2015, 225 limbs had been randomized to RFA, HLS, or CHIVA (n = 74, n = 75, and n = 76). Clinical follow-up and Doppler ultrasound examinations were performed at 1 week and 1, 6, 12, and 24 months postoperatively. No differences in postoperative complications or pain were observed among the three groups. RFA was noninferior to HLS and CHIVA for clinical recurrence at 24 months, with an estimated difference in recurrence of 3% (95% confidence interval [CI], -4.8% to 10.7%; noninferiority P = .002) and -7% (95% CI, -17% to 3%; P < .001), respectively. For ultrasound recurrence, RFA was noninferior to CHIVA, with an estimated difference of -34% (95% CI, -47% to -20%; noninferiority P < .001) at 24 months. However, noninferiority could not be demonstrated compared with HLS (5.9%; 95% CI, -4.1 to 15.9; P = .073). No differences were found in quality of life among the three groups. CONCLUSIONS RFA was shown to be noninferior in terms of clinical recurrence to HLS and CHIVA in the treatment of VVs due to GSV insufficiency.",2020,No differences in postoperative complications or pain were observed between groups.,"['patients with primary varicose veins (VV) due to great saphenous vein (GSV) insufficiency', 'primary VV due to GSV insufficiency', 'From December 2012 to June 2015, 225 limbs', 'Patients aged over 18 years with primary VV and GSV incompetence, with or without clinical symptoms, C2 - C6 clinical class of CEAP and GSV diameter >4 mm']","['radiofrequency with stripping and CHIVA technique', 'radiofrequency ablation (RFA', 'RFA, HL/S or CHIVA', 'stripping (HL/S) and CHIVA methods']","['quality of life', 'Rate of clinical recurrence', 'clinical recurrence', 'postoperative complications or pain', 'Ultrasound recurrence, safety and quality of life', 'recurrence', 'RFA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]",,0.176517,No differences in postoperative complications or pain were observed between groups.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'González Cañas', 'Affiliation': 'Department of Vascular Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain. Electronic address: egonzalez@tauli.cat.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Florit López', 'Affiliation': 'Department of Vascular Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain.'}, {'ForeName': 'Roser Vives', 'Initials': 'RV', 'LastName': 'Vilagut', 'Affiliation': 'Department of Pharmacology, Therapeutics, and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Kerbi Alejandro', 'Initials': 'KA', 'LastName': 'Guevara-Noriega', 'Affiliation': 'Department of General Surgery, Jackson Memorial Hospital, University of Miami, Miami, Fla.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santos Espí', 'Affiliation': 'Department of Vascular Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Rios', 'Affiliation': 'Biostatistics Unit, Universitat Autònoma de Barcelona, Barcelona, Spain; Medical Statistics Core Facility, Institut Investigacions Biomèdiques Audgust Pi I Sunyer (IDIBAPS) and Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Salvador Navarro', 'Initials': 'SN', 'LastName': 'Soto', 'Affiliation': 'Department of General Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Giménez Gaibar', 'Affiliation': 'Department of Vascular Surgery, Parc Taulí Hospital Universitari, Sabadell, Barcelona, Spain.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.04.019'] 44,32349977,Bioimpedance Guided Fluid Management in Peritoneal Dialysis: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES Bioelectrical impedance analysis (BIA) devices can help assess volume overload in patients receiving maintenance peritoneal dialysis. However, the effects of BIA on the short-term hard end points of peritoneal dialysis lack consistency. This study aimed to test whether BIA-guided fluid management could improve short-term outcomes in patients on peritoneal dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS A single-center, open-labeled, randomized, controlled trial was conducted. Patients on prevalent peritoneal dialysis with volume overload were recruited from July 1, 2013 to March 30, 2014 and followed for 1 year in the initial protocol. All participants with volume overload were 1:1 randomized to the BIA-guided arm (BIA and traditional clinical methods) and control arm (only traditional clinical methods). The primary end point was all-cause mortality and secondary end points were cardiovascular disease mortality and technique survival. RESULTS A total of 240 patients (mean age, 49 years; men, 51%; diabetic, 21%, 120 per group) were enrolled. After 1-year follow-up, 11(5%) patients died (three in BIA versus eight in control) and 21 patients were permanently transferred to hemodialysis (eight in BIA versus 13 in control). The rate of extracellular water/total body water decline in the BIA group was significantly higher than that in the control group. The 1-year patient survival rates were 96% and 92% in BIA and control groups, respectively. No significant statistical differences were found between patients randomized to the BIA-guided or control arm in terms of patient survival, cardiovascular disease mortality, and technique survival ( P >0.05). CONCLUSIONS Although BIA-guided fluid management improved the fluid overload status better than the traditional clinical method, no significant effect was found on 1-year patient survival and technique survival in patients on peritoneal dialysis.",2020,"No significant statistical differences were found between patients randomized to the BIA-guided or control arm in terms of patient survival, cardiovascular disease mortality, and technique survival ( P >0.05). ","['patients on peritoneal dialysis', 'Peritoneal Dialysis', 'patients receiving maintenance peritoneal dialysis', '240 patients (mean age, 49 years; men, 51%; diabetic, 21%, 120 per group) were enrolled', 'Patients on prevalent peritoneal dialysis with volume overload were recruited from July 1, 2013 to March 30, 2014 and followed for 1 year in the initial protocol', 'All participants with volume overload']","['BIA-guided fluid management', 'Bioimpedance Guided Fluid Management', 'BIA-guided arm (BIA and traditional clinical methods) and control arm (only traditional clinical methods']","['patient survival, cardiovascular disease mortality, and technique survival', '1-year patient survival and technique survival', 'rate of extracellular water/total body water decline', 'cardiovascular disease mortality and technique survival', 'cause mortality', '1-year patient survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",240.0,0.0676254,"No significant statistical differences were found between patients randomized to the BIA-guided or control arm in terms of patient survival, cardiovascular disease mortality, and technique survival ( P >0.05). ","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Tian', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qunying', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Statistics, Clinical Trials Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China yuxq@mail.sysu.edu.cn.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianxiong', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peiyi', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China yuxq@mail.sysu.edu.cn.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06480619'] 45,32353342,"Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial.","BACKGROUND Patients with HER2-positive breast cancer who have received two or more previous therapies for advanced disease have few effective treatment options. The monarcHER trial aimed to compare the efficacy of abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab in women with advanced breast cancer. METHODS This phase 2, three-group, open-label trial was done across 75 hospitals, clinics, and medical centres in 14 countries. Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease. Patients were randomly assigned 1:1:1 to the abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab (group C). Oral abemaciclib 150 mg 12 hourly was administered on days 1-21 of a 21-day cycle, intravenous trastuzumab 8 mg/kg on cycle 1 day 1, followed by 6 mg/kg on day 1 of each subsequent 21-day cycle, and intramuscular fulvestrant 500 mg on days 1, 15, and 29 and once every 4 weeks thereafter. Standard-of-care chemotherapy was administered as specified by the product label. Randomisation was by a computer-generated random sequence by means of an interactive web-response system and stratified by number of previous systemic therapies for advanced breast cancer and measurable versus non-measurable disease. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population, first testing group A versus group C and, if this result was significant, then group B versus group C. Safety was assessed in all patients who had received at least one dose of study treatment. This trial is registered at ClinicalTrials.gov (NCT02675231) and is ongoing for long-term survival follow-up. FINDINGS Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients were enrolled and randomly assigned to groups A (n=79), B (n=79), and C (n=79). Median follow-up was 19·0 months (IQR 14·7-25·1). The study met its primary endpoint, showing a significant difference at the prespecified two-sided α of 0·2 in median progression-free survival between group A (8·3 months, 95% CI 5·9-12·6) and group C (5·7 months, 5·4-7·0; HR 0·67 [95% CI 0·45-1·00]; p=0·051). No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77). The most common grade 3-4 treatment-emergent adverse event in groups A, B, and C was neutropenia (21 [27%] of 78 patients, 17 [22%] of 77, and 19 [26%] of 72). The most common serious adverse events were: in group A, pyrexia (three [4%]), diarrhoea (two [3%]), urinary tract infection (two [3%]), and acute kidney injury (two [3%]); in group B, diarrhoea (two [3%]) and pneumonitis (two [3%]); and in group C, neutropenia (four [6%]) and pleural effusion (two [3%]). Two deaths were attributed to treatment: one due to pulmonary fibrosis in group B and one due to febrile neutropenia in group C. INTERPRETATION The combination of abemaciclib, fulvestrant, and trastuzumab significantly improved progression-free survival versus standard-of-care chemotherapy plus trastuzumab while showing a tolerable safety profile. Our results suggest that a chemotherapy-free regimen might potentially be an alternative treatment option for patients with hormone receptor-positive, HER2-positive advanced breast cancer. FUNDING Eli Lilly and Company.",2020,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","['women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER', '75 hospitals, clinics, and medical centres in 14 countries', 'patients with hormone receptor-positive, HER2-positive advanced breast cancer', 'Patients with HER2-positive breast cancer', 'Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients', 'women with advanced breast cancer', 'Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease']","['Standard-of-care chemotherapy', ""abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab"", 'Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy', 'Oral abemaciclib', 'abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab']","['pneumonitis', 'febrile neutropenia', 'neutropenia', 'median progression-free survival', 'progression-free survival', 'acute kidney injury', 'diarrhoea', 'pyrexia', 'urinary tract infection', 'pleural effusion', 'investigator-assessed progression-free survival']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",325.0,0.211064,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: sara_tolaney@dfci.harvard.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wardley', 'Affiliation': 'The NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zambelli', 'Affiliation': 'Istituto Di Ricovero e Cura a Carattere Scientifico, Ospedale San Raffaele, IRCCS, Milano, Italy.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Troso-Sandoval', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Institut Curie, PSL Research University, Department of Medical Oncology, Paris, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Stephen Rd', 'Initials': 'SR', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-WA, Nedlands, WA, Australia; Curtin University, Nedlands, WA, Australia.'}, {'ForeName': 'Shom', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; The Sir Peter MacCallum Department of Medical Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Catron', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Sonya C', 'Initials': 'SC', 'LastName': 'Chapman', 'Affiliation': 'Eli Lilly, Windlesham, UK.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'M Corona', 'Initials': 'MC', 'LastName': 'Gainford', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Gustave Roussy, Université Paris Saclay, INSERM, Villejuif, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30112-1'] 46,32353418,Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial.,"BACKGROUND Fluid and vasopressor management in septic shock remains controversial. In this randomized controlled trial, we evaluated the efficacy of dynamic measures (stroke volume change during passive leg raise) to guide resuscitation and improve patient outcome. RESEARCH QUESTION Will resuscitation that is guided by dynamic assessments of fluid responsiveness in patients with septic shock improve patient outcomes? STUDY DESIGN AND METHODS We conducted a prospective, multicenter, randomized clinical trial at 13 hospitals in the United States and United Kingdom. Patients presented to EDs with sepsis that was associated hypotension and anticipated ICU admission. Intervention arm patients were assessed for fluid responsiveness before clinically driven fluid bolus or increase in vasopressors occurred. The protocol included reassessment and therapy as indicated by the passive leg raise result. The control arm received usual care. The primary clinical outcome was positive fluid balance at 72 hours or ICU discharge, whichever occurred first. RESULTS In modified intent-to-treat analysis that included 83 intervention and 41 usual care eligible patients, fluid balance at 72 hours or ICU discharge was significantly lower (-1.37 L favoring the intervention arm; 0.65 ± 2.85 L intervention arm vs 2.02 ± 3.44 L usual care arm; P = .021. Fewer patients required renal replacement therapy (5.1% vs 17.5%; P = .04) or mechanical ventilation (17.7% vs 34.1%; P = .04) in the intervention arm compared with usual care. In the all-randomized intent-to-treat population (102 intervention, 48 usual care), there were no significant differences in safety signals. INTERPRETATION Physiologically informed fluid and vasopressor resuscitation with the use of the passive leg raise-induced stroke volume change to guide management of septic shock is safe and demonstrated lower net fluid balance and reductions in the risk of renal and respiratory failure. Dynamic assessments to guide fluid administration may improve outcomes for patients with septic shock compared with usual care. CLINICAL TRIAL REGISTRATION NCT02837731.",2020,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","['Sepsis Hypotension and Shock', 'septic shock patients', 'patients with septic shock', '13 hospitals in the United States and United Kingdom', 'Patients presented to Emergency Rooms with sepsis associated hypotension and anticipated Intensive Care Unit (ICU) admission']","['Usual Care', 'Fluid Response Evaluation']","['renal replacement therapy', 'fluid responsiveness', 'mechanical ventilation', 'safety signals', 'positive fluid balance at 72 hours or ICU discharge, whichever occurred first']","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C2364300', 'cui_str': 'Positive fluid balance'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",,0.241826,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","[{'ForeName': 'Ivor S', 'Initials': 'IS', 'LastName': 'Douglas', 'Affiliation': 'Denver Health Medical Center and University of Colorado, Anschutz Medical Campus, Denver, CO. Electronic address: idouglas@dhha.org.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Alapat', 'Affiliation': 'Ben Taub Hospital, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Corl', 'Affiliation': 'Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Exline', 'Affiliation': 'Ohio State University Hospital, Columbus, OH.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Faculty of Health Sciences, University of Surrey & Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Andre L', 'Initials': 'AL', 'LastName': 'Holder', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'NYU School of Medicine, New York, NY; Bridgeport Hospital, Bridgeport, CT.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Levy', 'Affiliation': 'Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Sahatjian', 'Affiliation': 'Cheetah Medical, Wilmington, DE.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Seeley', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Weingarten', 'Affiliation': 'New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Hansell', 'Affiliation': 'Cheetah Medical, Wilmington, DE; Massachusetts General Hospital, Boston, MA.'}]",Chest,['10.1016/j.chest.2020.04.025'] 47,32353419,"Impact of transcranial direct current stimulation on sustained attention in breast cancer survivors: Evidence for feasibility, tolerability, and initial efficacy.","BACKGROUND A significant subset of breast cancer survivors experience cognitive difficulties in attention and memory, which persist for years following treatment. Transcranial direct current stimulation (tDCS) has been shown to be effective in improving working memory, attention, processing speed, and other cognitive functions in both healthy and clinical populations. To date, no studies have examined tDCS for rehabilitation of cancer-related cognitive dysfunction. OBJECTIVE/HYPOTHESIS We aimed to provide preliminary evidence for feasibility, tolerability, acceptability, and efficacy of tDCS in improving performance on a measure of sustained attention. METHODS In a within-subjects design, 16 breast cancer survivors underwent 2 consecutive days of active tDCS over the prefrontal cortex, and 2 days of sham tDCS, counterbalanced for order of stimulation condition, while performing a continuous performance test. RESULTS Stimulation was feasible and tolerable, with 89% of participants completing all sessions, and none reporting more than mild to moderate discomfort. Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p < 0.05). Furthermore, the effect of stimulation on standard errors of reaction times differed by inter-stimulus interval (ISI): for 1 and 2 s ISIs, there was no significant difference in performance between sham and active tDCS conditions, but for 4 s ISIs, stimulation improved variability in response times relative to sham (p < 0.05). CONCLUSIONS Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer-related cognitive dysfunction.",2020,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","['survivors with cancer-related cognitive dysfunction', 'breast cancer survivors', '16 breast cancer survivors']","['Transcranial direct current stimulation (tDCS', 'tDCS', 'active tDCS', 'transcranial direct current stimulation']","['feasibility, tolerability, acceptability, and efficacy', 'standard errors of reaction times']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.118383,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Gaynor', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA. Electronic address: gaynora@mskcc.org.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Pergolizzi', 'Affiliation': 'Universitat Internacional de Catalunya, School of Medicine and Health Sciences, Barcelona, Spain.'}, {'ForeName': 'Yesne', 'Initials': 'Y', 'LastName': 'Alici', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Katrazyna', 'Initials': 'K', 'LastName': 'McNeal', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.04.013'] 48,32367234,Is selective nerve root block necessary for learning percutaneous endoscopic lumbar discectomy: a comparative study using a cumulative summation test for learning curve.,"PURPOSE The aim of this study was to investigate the effect of lumbar spine selective nerve root block (SNRB) experience on the learning efficiency of percutaneous endoscopic lumbar discectomy (PELD) for junior trainees. METHODS A total of 480 patients undergoing single-level PELD performed by eight junior trainees were included. The trainees were divided into two groups based on whether they had previous SNRB experience (group A, yes; group B, no). Surgical proficiency was defined as total operation time less than 65 minutes and cumulative radiation exposure time no more than 40 seconds. The learning curve was analyzed by cumulative summation (CUSUM) test. Clinical evaluations included Macnab classification, visual analog scale (VAS)-low back score, VAS-leg score, and Oswestry Disability Index (ODI). Follow-up information at 12 months was also obtained. RESULTS Integral number of cases before achieving an acceptable surgical level in group A (47.75 ± 2.50 cases) was significantly smaller than that in group B (56.50 ± 1.29 cases, p < 0.05), along with less accumulated failure (18.75 ± 0.96 cases vs. 25.50 ± 1.75 cases, p < 0.05). The two groups were comparable in clinical outcomes. Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05). CONCLUSION Previous experience of SNRB improved the performance of PELD with shorter operation time and less radiation exposure. SNRB practice may reduce the complication rate without a significant effect on the recurrence of symptoms and reoperation.",2020,"Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05). ","['junior trainees', '480 patients undergoing single-level PELD performed by eight junior trainees were included']","['lumbar spine selective nerve root block (SNRB) experience', 'percutaneous endoscopic lumbar discectomy (PELD']","['total operation time less', 'complications', 'acceptable surgical level', 'cumulative radiation exposure time', 'complication rate', 'recurrence of symptoms and reoperation', 'Macnab classification, visual analog scale (VAS)-low back score, VAS-leg score, and Oswestry Disability Index (ODI']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",480.0,0.0260394,"Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05). ","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Huiqiao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Yunhao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Orthopaedics, The 455th Hospital of Chinese People's Liberation Army, Shanghai, China.""}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. guxin2004ty@163.com.""}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. charlieshi@smmu.edu.cn.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}]",International orthopaedics,['10.1007/s00264-020-04558-1'] 49,32365226,"A randomized phase 2 study of temsirolimus and cetuximab versus temsirolimus alone in recurrent/metastatic, cetuximab-resistant head and neck cancer: The MAESTRO study.","BACKGROUND Patients with cetuximab-resistant, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) have poor outcomes. This study hypothesized that dual blockade of mammalian target of rapamycin and epidermal growth factor receptor (EGFR) would overcome cetuximab resistance on the basis of the role of phosphoinositide 3-kinase signaling in preclinical models of EGFR resistance. METHODS In this multicenter, randomized clinical study, patients with recurrent/metastatic HNSCC with documented progression on cetuximab (in any line in the recurrent/metastatic setting) received 25 mg of temsirolimus weekly plus cetuximab at 400/250 mg/m 2 weekly (TC) or single-agent temsirolimus (T). The primary outcome was progression-free survival (PFS) in the TC arm versus the T arm. Response rates, overall survival, and toxicity were secondary outcomes. RESULTS Eighty patients were randomized to therapy with TC or T alone. There was no difference for the primary outcome of median PFS (TC arm, 3.5 months; T arm, 3.5 months). The response rate was 12.5% in the TC arm (5 responses, including 1 complete response [2.5%]) and 2.5% in the T arm (1 partial response; P = .10). Responses were clinically meaningful in the TC arm (range, 3.6-9.1 months) but not in the T-alone arm (1.9 months). Fatigue, electrolyte abnormalities, and leukopenia were the most common grade 3 or higher adverse events and occurred in less than 20% of patients in both arms. CONCLUSIONS The study did not meet its primary endpoint of improvement in PFS. However, TC induced responses in cetuximab-refractory patients with good tolerability. The post hoc observation of activity in patients with acquired resistance (after prior benefit from cetuximab monotherapy) may warrant further investigation.",2020,"There was no difference for the primary outcome of median PFS (TC arm, 3.5 months; T arm, 3.5 months).","['Eighty patients', 'patients with recurrent/metastatic HNSCC with documented progression on cetuximab (in any line in the recurrent/metastatic setting', 'Patients with cetuximab-resistant, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC', 'recurrent/metastatic, cetuximab-resistant head and neck cancer', 'patients with acquired resistance (after prior benefit from cetuximab monotherapy']","['rapamycin and epidermal growth factor receptor (EGFR', '25\xa0mg of temsirolimus weekly plus cetuximab at 400/250\xa0mg/m 2 weekly (TC) or single-agent temsirolimus (T', 'temsirolimus and cetuximab versus temsirolimus alone', 'TC']","['PFS', 'Response rates, overall survival, and toxicity', 'Fatigue, electrolyte abnormalities, and leukopenia', 'progression-free survival (PFS', 'response rate', 'median PFS']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",80.0,0.0383175,"There was no difference for the primary outcome of median PFS (TC arm, 3.5 months; T arm, 3.5 months).","[{'ForeName': 'Tanguy Y', 'Initials': 'TY', 'LastName': 'Seiwert', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kochanny', 'Affiliation': 'Comprehensive Cancer Center, University of Chicago Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wood', 'Affiliation': 'Valley Health System, Paramus, New Jersey, USA.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Worden', 'Affiliation': 'Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Siteman Cancer Center, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Decatur Memorial Hospital, Decatur, Illinois, USA.'}, {'ForeName': 'Bethany G', 'Initials': 'BG', 'LastName': 'Sleckman', 'Affiliation': 'David C. Pratt Cancer Center, Mercy Hospital, St. Louis, Missouri, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, Minnesota, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Brisson', 'Affiliation': 'William Beaumont School of Medicine, Oakland University, Rochester, Michigan, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Karrison', 'Affiliation': 'Comprehensive Cancer Center, University of Chicago Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'Comprehensive Cancer Center, University of Chicago Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'Comprehensive Cancer Center, University of Chicago Medicine, Chicago, Illinois, USA.'}]",Cancer,['10.1002/cncr.32929'] 50,32366578,Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial.,"OBJECTIVE The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial (ClinicalTrials.gov reg. no. NCT01179048) demonstrated a reduced risk of cardiovascular (CV) events for patients with type 2 diabetes who received the glucagon-like peptide 1 receptor agonist liraglutide versus placebo. The mechanisms behind this CV benefit remain unclear. We aimed to identify potential mediators for the CV benefit observed with liraglutide in the LEADER trial. RESEARCH DESIGN AND METHODS We performed exploratory analyses to identify potential mediators of the effect of liraglutide on major adverse CV events (MACE; composite of CV death, nonfatal myocardial infarction, or nonfatal stroke) from the following candidates: glycated hemoglobin (HbA 1c ), body weight, urinary albumin-to-creatinine ratio (UACR), confirmed hypoglycemia, sulfonylurea use, insulin use, systolic blood pressure, and LDL cholesterol. These candidates were selected as CV risk factors on which liraglutide had an effect in LEADER such that a reduction in CV risk might result. We used two methods based on a Cox proportional hazards model and the new Vansteelandt method designed to use all available information from the mediator and to control for confounding factors. RESULTS Analyses using the Cox methods and Vansteelandt method indicated potential mediation by HbA 1c (up to 41% and 83% mediation, respectively) and UACR (up to 29% and 33% mediation, respectively) on the effect of liraglutide on MACE. Mediation effects were small for other candidates. CONCLUSIONS These analyses identify HbA 1c and, to a lesser extent, UACR as potential mediators of the CV effects of liraglutide. Whether either is a marker of an unmeasured factor or a true mediator remains a key question that invites further investigation.",2020,"Mediation effects were small for other candidates. ",['patients with type 2 diabetes who received the'],"['liraglutide', 'glucagon-like peptide 1 receptor agonist liraglutide versus placebo', 'Liraglutide']","['UACR', 'potential mediation by HbA 1c', 'risk of cardiovascular (CV) events', 'glycated hemoglobin (HbA 1c ), body weight, urinary albumin-to-creatinine ratio (UACR), confirmed hypoglycemia, sulfonylurea use, insulin use, systolic blood pressure, and LDL cholesterol', 'major adverse CV events (MACE; composite of CV death, nonfatal myocardial infarction, or nonfatal stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0770687,"Mediation effects were small for other candidates. ","[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC jbuse@med.unc.edu.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Swansea University Medical School, Swansea, U.K.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Centre, Munich, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, U.K.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'School of Public Health, Imperial College London, London, U.K.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, FL.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Linder', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Monk Fries', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ørsted', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2251'] 51,32374239,Tranexamic acid in total knee replacement which protocol? which application form? A prospective randomised study.,"The aim of this study was to prospectively compare different delivery forms, doses and combined application forms of TXA for the reduction of blood loss and prevention of the allogeneic blood transfusion in patients with TKA and evaluate the results. The study included patients with knee joint osteoarthritis who were unresponsive to conservative management and 168 patients met the inclusion criteria. They were divided into 5 groups randomly as, Control (1), Local (2), Systemic+short infusion (3), Systemic+long infusion (4) and Systemic+oral TXA (5). When compared with the Control group, blood loss was significantly reduced in Groups 2, 3 and 4 (p=0.001, 0.001, 0.003) but not in Group 5. Twenty- four hour drainage output was lower in all treatment groups (p=0.001, 0.001, 0.001, 0.004). Although TXA groups had no difference in terms of blood loss, 24- hour drainage outputs of the local TXA group were less than Group 4 and 5 and it yielded similar amounts in comparison with group 3. It was determined that TXA use whether local or systemic gave rise to decreased blood loss and prevent allogeneic blood transfusion. But, regarding the results above, local TXA seemed to have favorable effects when compared with systemic+long infusion and systemic+oral TXA usage, whereas local use had similar results with systemic+short infusion. Additionally, there found no difference between systemic+short, systemic+long infusion and systemic+oral combined TXA usage with respect to blood loss, transfusion rates and drain follow-up. We recommend further prospective randomized controlled studies to make clear these differences. Systemic+oral combined TXA use have promising results when compared with other systemic multiple deliveries.",2019,"Twenty- four hour drainage output was lower in all treatment groups (p=0.001, 0.001, 0.001, 0.004).","['patients with TKA', 'patients with knee joint osteoarthritis who were unresponsive to conservative management and 168 patients met the inclusion criteria']","['Local (2), Systemic+short infusion (3), Systemic+long infusion (4) and Systemic+oral TXA (5', 'TXA', 'Systemic+oral combined TXA', 'Tranexamic acid']","['blood loss and prevent allogeneic blood transfusion', 'blood loss and prevention of the allogeneic blood transfusion', 'blood loss, 24- hour drainage outputs', 'blood loss, transfusion rates and drain follow-up', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0545919,"Twenty- four hour drainage output was lower in all treatment groups (p=0.001, 0.001, 0.001, 0.004).","[{'ForeName': 'İsmail Gökhan', 'Initials': 'İG', 'LastName': 'Şahin', 'Affiliation': ''}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Akalin', 'Affiliation': ''}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Çevik', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Otuzbir', 'Affiliation': ''}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Özkan', 'Affiliation': ''}, {'ForeName': 'Alpaslan', 'Initials': 'A', 'LastName': 'Öztürk', 'Affiliation': ''}]",Acta orthopaedica Belgica,[] 52,32358310,"Effects of Training With Free Weights Versus Machines on Muscle Mass, Strength, Free Testosterone, and Free Cortisol Levels.","Schwanbeck, SR, Cornish, SM, Barss, T, and Chilibeck, PD. Effects of training with free weights versus machines on muscle mass, strength, free testosterone, and free cortisol levels. J Strength Cond Res 34(7): 1851-1859, 2020-Free weights offer a more unstable training environment, which enhances muscle recruitment, whereas some machines have the advantage of using a ""cam"" pulley system that better matches strength curves. We compared the effect of training with free weights vs. machines on muscle mass, strength, free testosterone, and free cortisol concentrations. Forty-six subjects (26 women; 22 ± 3 years) were randomized to train using free weights or machines for 8 weeks (with each muscle group trained 2-3/weeks, 3-4 sets of 4-10 repetitions). Muscle thickness and strength were measured at 0 and 8 weeks. Salivary hormone concentrations were assessed before and at the end of workouts at the beginning, midway (4 weeks), and end (8 weeks) of the training intervention. Biceps and quadriceps muscle thickness increased (p < 0.01) with no difference between groups. There was a group × time interaction for machine bench press strength (p = 0.05) with the machine group increasing more than the free-weight group (13.9 vs. 8.6%). Free-weight bench press and squat, and Smith machine squat strength increased in both groups (11-19%; p < 0.01) with no difference between groups. Men in the free-weight group had a greater increase in free testosterone from before to after acute training sessions than men in the machine group and all women (p < 0.01); however, there was no differences between groups in free cortisol response to acute resistance exercise. Training sessions with free weights induced greater increases in free testosterone in men; however, training with free weights or machines resulted in similar increases in muscle mass and strength.",2020,There was a group × time interaction for machine bench press strength (p = 0.05) with the machine group increasing more than the free-weight group (13.9 vs. 8.6%).,['Forty-six subjects (26 women; 22 ± 3 years'],"['J Strength Cond Res XX(X', 'Training With Free Weights Versus Machines']","['Free-weight bench press and squat, and Smith machine squat strength', 'Salivary hormone concentrations', 'Schwanbeck, SR, Cornish, SM, Barss, T, and Chilibeck, PD', 'muscle mass, strength, free testosterone, and free cortisol levels', 'muscle mass and strength', 'free testosterone', 'Muscle Mass, Strength, Free Testosterone, and Free Cortisol Levels', 'Biceps and quadriceps muscle thickness', 'Muscle thickness and strength', 'free cortisol response to acute resistance exercise', 'muscle mass, strength, free testosterone, and free cortisol concentrations', 'time interaction for machine bench press strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0682388', 'cui_str': 'Cornish language'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0236401', 'cui_str': 'Cortisol, free measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",46.0,0.0269838,There was a group × time interaction for machine bench press strength (p = 0.05) with the machine group increasing more than the free-weight group (13.9 vs. 8.6%).,"[{'ForeName': 'Shane R', 'Initials': 'SR', 'LastName': 'Schwanbeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Cornish', 'Affiliation': 'Faculty of Kinesiology and Recreation Management, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Barss', 'Affiliation': 'Faculty of Medicine and Dentistry, Neuroscience and Mental Health Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003349'] 53,32294257,Mechanisms and impacts of an incentive-based conservation program with evidence from a randomized control trial.,"Conservation science needs more high-quality impact evaluations, especially ones that explore mechanisms of success or failure. Randomized control trials (RCTs) provide particularly robust evidence of the effectiveness of interventions (although they have been criticized as reductionist and unable to provide insights into mechanisms), but there have been few such experiments investigating conservation at the landscape scale. We explored the impact of Watershared, an incentive-based conservation program in the Bolivian Andes, with one of the few RCTs of landscape-scale conservation in existence. There is strong interest in such incentive-based conservation approaches as some argue they can avoid negative social impacts sometimes associated with protected areas. We focused on social and environmental outcomes based on responses from a household survey in 129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015-2016). We controlled for incomplete program uptake by combining standard RCT analysis with matching methods and investigated mechanisms by exploring intermediate and ultimate outcomes according to the underlying theory of change. Previous analyses, focused on single biophysical outcomes, showed that over its first 5 years Watershared did not slow deforestation or improve water quality at the landscape scale. We found that Watershared influenced some outcomes measured using the survey, but the effects were complex, and some were unexpected. We thus demonstrated how RCTs can provide insights into the pathways of impact, as well as whether an intervention has impact. This paper, one of the first registered reports in conservation science, demonstrates how preregistration can help make complex research designs more transparent, avoid cherry picking, and reduce publication bias.",2020,We focused on social and environmental outcomes based on responses from a household survey in 129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015/16).,['129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015/16'],['incentive-based conservation program'],['water quality'],"[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0597680', 'cui_str': 'Water Quality'}]",,0.0477643,We focused on social and environmental outcomes based on responses from a household survey in 129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015/16).,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wiik', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Julia P G', 'Initials': 'JPG', 'LastName': 'Jones', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Pynegar', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bottazzi', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Asquith', 'Affiliation': 'Sustainability Science Program, Harvard Kennedy School, Cambridge, MA, 02138, U.S.A.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gibbons', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kontoleon', 'Affiliation': 'Department of Land Economy, University of Cambridge, 19 Silber Street, Cambridge, CB3 9EP, U.K.'}]",Conservation biology : the journal of the Society for Conservation Biology,['10.1111/cobi.13508'] 54,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268'] 55,32361196,Progressive Muscle Relaxation and guided imagery as techniques to enhance the way of coping of parents of children with malignancies: Findings from a randomized controlled trial.,"PURPOSE The aim of this study was to test the effectiveness of relaxation techniques in altering the coping strategies that were employed by the parents of children with malignancy on active treatment. METHODS It was a randomized non-blinded controlled trial, including pre - and post assessments, comparing a 3-week relaxation intervention with the standard psychological care. Participants were recruited consecutively from two Public Pediatric Oncology - Hematology Departments in Cyprus and Greece. Fifty four parents of children hospitalized with a malignancy, were randomly assigned either to the intervention group (n = 29), receiving the Progressive Muscle Relaxation (PMR) and Guided Imagery (GI) Relaxation Techniques or to the control group (n = 25) receiving only the Standard Psychological Care by nurses and psychologists. Data were collected with the Questionnaire of 'Ways of Coping Checklist' (WofCC). RESULTS The results showed that the intervention did not have an impact on the coping strategies that parents employed as these are reflected on the WofCC' factors. The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming. CONCLUSIONS The findings did not support the utilization of PMR and GI as coping strategies altering interventions in this clinical context. However, these findings should be interpreted in light of the short duration of the intervention that under these specific circumstances might have required a more lengthy approach for coping strategies to be altered. Furthermore, the stress relieving properties of these interventions could fortify (although not altering) existing coping strategies.",2020,"The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming. ","['parents of children with malignancies', 'parents of children with malignancy on active treatment', 'Fifty four parents of children hospitalized with a malignancy', 'Participants were recruited consecutively from two Public Pediatric Oncology - Hematology Departments in Cyprus and Greece']","['Progressive Muscle Relaxation (PMR) and Guided Imagery (GI) Relaxation Techniques or to the control group (n\xa0=\xa025) receiving only the Standard Psychological Care by nurses and psychologists', 'Progressive Muscle Relaxation and guided imagery', 'relaxation intervention with the standard psychological care']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0587491', 'cui_str': 'Hematology department'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0307766,"The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming. ","[{'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Tsitsi', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Limassol, Cyprus. Electronic address: theologia.tsitsi@cut.ac.cy.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Raftopoulos', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Mediterranean Research Centre for Public Health and Quality of Care, Limassol, Cyprus. Electronic address: vraftop1@gmail.com.'}, {'ForeName': 'Evridiki', 'Initials': 'E', 'LastName': 'Papastavrou', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Limassol, Cyprus. Electronic address: e.papastavrou@cut.ac.cy.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Charalambous', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Research Centre for Oncology and Palliative Care, Limassol, Cyprus. Electronic address: andreas.charalambous@cut.ac.cy.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101718'] 56,32361220,Clinical impact of lung ultrasound monitoring for diagnosis of ventilator associated pneumonia: A diagnostic randomized controlled trial.,"PURPOSE Studies have shown that lung-ultrasound may be superior to chest x-ray (CXR) in diagnosing ventilator-associated pneumonia (VAP). This study investigated whether the use of lung-ultrasound monitoring could detect VAP earlier and improve patient outcome. METHODS This was a single-center diagnostic randomized controlled trial. In the control group, VAP was diagnosed using a combination of CXR and clinical findings. In the intervention group, VAP was diagnosed using a combination of lung-ultrasound and clinical findings. The primary outcome measured was ventilator free days (VFD). Secondary outcomes were ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days. RESULTS We randomized intubated patients until 44 VAP diagnosis was made in each group. VFD was higher in the intervention group than in the control group (7.80+/- 9.7 days versus 3.7+/- 6.4 days, p = .044). There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70). CONCLUSION The use of lung-ultrasound monitoring for diagnosis of VAP improves patient outcome when compared to the standard diagnostic strategy that relies on CXR.",2020,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70). ",['diagnosis of ventilator associated pneumonia'],"['VAP', 'lung ultrasound monitoring', 'lung-ultrasound monitoring']","['ICU length of stay', 'delta SOFA', 'ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days', 'ICU mortality', 'antibiotic duration', 'ventilator free days (VFD', 'VFD']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.170703,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70). ","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal. Electronic address: saurabh_44@hotmail.com.'}, {'ForeName': 'Pramesh Sunder', 'Initials': 'PS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Gentle Sunder', 'Initials': 'GS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Moda Nath', 'Initials': 'MN', 'LastName': 'Marhatta', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.012'] 57,32362221,Amoxicillin or tetracycline in bismuth-containing quadruple therapy as first-line treatment for Helicobacter pylori infection.,"AIM To compare the efficacy and safety between modified quadruple- and bismuth-containing quadruple therapy as first-line eradication regimen for Helicobacter pylori infection. METHODS This study was a multicenter, randomized-controlled, non-inferiority trial. Subjects endoscopically diagnosed with H. pylori infection were randomly allocated to receive modified quadruple- (rabeprazole 20 mg bid, amoxicillin 1 g bid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid [elemental bismuth 480 mg]; PAMB) or bismuth-containing quadruple therapy (rabeprazole 20 mg bid, bismuth subcitrate 300 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid; PBMT) for 14 days. Rates of eradication success and adverse events were investigated. Antibiotic resistance was determined using the agar dilution and DNA sequencing of the clarithromycin resistance point mutations in the 23 S rRNA gene of H. pylori . RESULTS In total, 233 participants were randomized, 27 were lost to follow-up, and four violated the protocol. Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%, P = .37), modified intention-to-treat (96.2% vs. 96%, P > .99), and per-protocol (96.2% vs. 96.9%, P > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed. The amoxicillin-, metronidazole-, tetracycline-, clarithromycin-, and levofloxacin-resistance rates were 8.3, 40, 9.4, 23.5, and 42.2%, respectively. Antimicrobial resistance did not significantly affect the efficacy of either therapy. Overall compliance was 98.1%. Adverse events were not significantly different between the two therapies. CONCLUSION Modified quadruple therapy comprising rabeprazole, amoxicillin, metronidazole, and bismuth is an effective first-line treatment for the H. pylori infection in regions with high clarithromycin and metronidazole resistance.",2020,"Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%, P = .37), modified intention-to-treat (96.2% vs. 96%, P > .99), and per-protocol (96.2% vs. 96.9%, P > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed.","['Subjects endoscopically diagnosed with H. pylori infection', 'Helicobacter pylori infection', '233 participants']","['modified quadruple', 'Amoxicillin or tetracycline', 'rabeprazole 20 mg bid, amoxicillin 1\xa0g bid', 'modified quadruple- and bismuth-containing quadruple therapy', 'rabeprazole, amoxicillin, metronidazole, and bismuth', 'metronidazole 500 mg tid, bismuth subcitrate 300 mg qid [elemental bismuth 480 mg]; PAMB) or bismuth-containing quadruple therapy (rabeprazole 20 mg bid, bismuth subcitrate 300 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid; PBMT']","['acceptable eradication rate', 'Adverse events', 'amoxicillin-, metronidazole-, tetracycline-, clarithromycin-, and levofloxacin-resistance rates', 'efficacy and safety', 'Overall compliance', 'Antimicrobial resistance', 'Antibiotic resistance', 'Rates of eradication success and adverse events', 'modified intention-to-treat']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0992611', 'cui_str': 'Metronidazole 500 MG'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0106556', 'cui_str': 'bismuth subcitrate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",233.0,0.0671799,"Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%, P = .37), modified intention-to-treat (96.2% vs. 96%, P > .99), and per-protocol (96.2% vs. 96.9%, P > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed.","[{'ForeName': 'Chang Seok', 'Initials': 'CS', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Hae Min', 'Initials': 'HM', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Woon Geon', 'Initials': 'WG', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Institute of New Frontier Research, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Soh', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Ho Suk', 'Initials': 'HS', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Ji Taek', 'Initials': 'JT', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Suk Pyo', 'Initials': 'SP', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Suk', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Jae Jun', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Institute of New Frontier Research, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Gwang Ho', 'Initials': 'GH', 'LastName': 'Baik', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}]",Gut microbes,['10.1080/19490976.2020.1754118'] 58,32363411,Building Emotional Resilience in Youth in Lebanon: a School-Based Randomized Controlled Trial of the FRIENDS Intervention.,"In Lebanon, approximately one in four adolescents suffers from a psychiatric disorder. Alarmingly, 94% of adolescents with a mental disorder have not sought any treatment. This study assessed the effectiveness of an evidence-based school-based universal mental health intervention (the FRIENDS program) in reducing depression and anxiety symptoms in middle school students in Lebanon. A total of 280 6th graders aged 11-13 years were recruited from 10 schools in Beirut. Schools were matched on size and tuition and randomly assigned to intervention or control groups. The FRIENDS program was translated into Arabic, adapted, and then implemented by trained mental health professionals during 10 classroom sessions over 3 months. We assessed sociodemographic and relevant psychological symptoms by self-report, using the Scale for Childhood Anxiety and Related Disorders (SCARED), Mood and Feelings Questionnaire (MFQ), and Strengths and Difficulties Questionnaire (SDQ), at baseline. We re-administered these scales at 3 months post-intervention. There was a significant time × group interaction for the SDQ emotional score (p = 0.011) and total MFQ score (p = 0.039) indicating significant improvement in depressive and emotional symptoms in the intervention group. Subgroup analysis by gender showed a significant time × group interaction for the total SCARED score (p = 0.025) in females but not in males (p = 0.137), consistent with a reduction of anxiety symptoms in this stratum of the intervention group as compared with the control group. The FRIENDS program was effective in reducing general emotional and depressive symptoms among middle school students in this Lebanese study population. This intervention provides an opportunity for promoting mental health in Lebanese schools and reducing the treatment gap in mental health care.",2020,"Subgroup analysis by gender showed a significant time × group interaction for the total SCARED score (p = 0.025) in females but not in males (p = 0.137), consistent with a reduction of anxiety symptoms in this stratum of the intervention group as compared with the control group.","['A total of 280 6th graders aged 11-13\xa0years were recruited from 10 schools in Beirut', 'Youth in Lebanon', 'adolescents with a mental disorder', 'middle school students in Lebanon', 'middle school students in this Lebanese study population']",['evidence-based school-based universal mental health intervention (the FRIENDS program'],"['Childhood Anxiety and Related Disorders (SCARED), Mood and Feelings Questionnaire (MFQ), and Strengths and Difficulties Questionnaire (SDQ', 'Building Emotional Resilience', 'anxiety symptoms', 'total SCARED score', 'depressive and emotional symptoms', 'general emotional and depressive symptoms', 'depression and anxiety symptoms', 'SDQ emotional score', 'total MFQ score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",280.0,0.0621785,"Subgroup analysis by gender showed a significant time × group interaction for the total SCARED score (p = 0.025) in females but not in males (p = 0.137), consistent with a reduction of anxiety symptoms in this stratum of the intervention group as compared with the control group.","[{'ForeName': 'Fadi T', 'Initials': 'FT', 'LastName': 'Maalouf', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon. fm38@aub.edu.lb.'}, {'ForeName': 'Loay', 'Initials': 'L', 'LastName': 'Alrojolah', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Ghandour', 'Affiliation': 'Department of Epidemiology and Population, Faculty of Health Sciences, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon. lg01@aub.edu.lb.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Afifi', 'Affiliation': 'Community and Behavioral, College of Public Health, University of Iowa, Iowa, IA, USA.'}, {'ForeName': 'Leyla Akoury', 'Initials': 'LA', 'LastName': 'Dirani', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Barrett', 'Affiliation': 'Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nakkash', 'Affiliation': 'Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Shamseddeen', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Tabaja', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Yuen', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Becker', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01123-5'] 59,32360007,Volatile Anesthesia Versus Total Intravenous Anesthesia During Cardiopulmonary Bypass: A Narrative Review on the Technical Challenges and Considerations.,The Mortality in Cardiac Surgery Randomized Controlled Trial of Volatile Anesthetics (MYRIAD) demonstrated that cardiac surgery with either volatile anesthesia or intravenous anesthesia techniques can be comparable with respect to morbidity and mortality. Maintaining anesthesia during cardiopulmonary bypass (CPB) with either approach requires appreciation of the nuances that are unique to each. This narrative review addresses these technical challenges and other considerations.,2020,Maintaining anesthesia during cardiopulmonary bypass (CPB) with either approach requires appreciation of the nuances that are unique to each.,['During Cardiopulmonary Bypass'],"['Volatile Anesthetics (MYRIAD', 'Volatile Anesthesia Versus Total Intravenous Anesthesia', 'cardiopulmonary bypass (CPB', 'volatile anesthesia or intravenous anesthesia techniques']",['morbidity and mortality'],"[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0190044,Maintaining anesthesia during cardiopulmonary bypass (CPB) with either approach requires appreciation of the nuances that are unique to each.,"[{'ForeName': 'Chuen Jye', 'Initials': 'CJ', 'LastName': 'Yeoh', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore; Department of Cardiothoracic Anaesthesia, National Heart Centre, Singapore.'}, {'ForeName': 'Nian Chih', 'Initials': 'NC', 'LastName': 'Hwang', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore; Department of Cardiothoracic Anaesthesia, National Heart Centre, Singapore. Electronic address: hwang.nian.chih@singhealth.com.sg.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.013'] 60,32360038,Outcomes After Left Main Coronary Artery Revascularization by Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting According to Smoking Status.,"Cigarette smoking is a well-known risk factor for coronary artery disease (CAD). However, the impact of smoking on outcomes after coronary revascularization, especially in patients with left main CAD (LMCAD) is less well understood. The EXCEL trial randomized 1,905 patients with LMCAD and visually assessed low or intermediate anatomical complexity (SYNTAX score ≤32) to PCI with everolimus-eluting stents or CABG. Patients were categorized according to smoking status (current, former, or never), and their outcomes at 5 years were compared by logistic regression with follow-up time included as a log-transformed offset variable. The primary endpoint was a composite of death, myocardial infarction, or stroke. Among 1893 patients with known smoking status at baseline, 416 (22%) were current smokers and 774 (41%) were former smokers. The crude rates of the primary endpoint were 19.5% for never smokers, 20.5% for former smokers (p = 0.61 vs never smokers), and 23.1% for smokers (p = 0.15 vs never smokers). Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10). The relative efficacy of PCI versus CABG for the 5-year primary endpoint was similar irrespective of smoking status (P interaction  = 0.22). In conclusion, current smokers in the EXCEL trial had a higher adjusted 5-year risk of the primary composite endpoint of death, myocardial infarction, or stroke than never smokers, whereas former smokers were not at increased risk. Active smoking was a risk factor after LMCAD revascularization irrespective of revascularization method.",2020,"Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10).","['patients with left main CAD (LMCAD', '1,905 patients with LMCAD and visually assessed low or intermediate anatomical complexity (SYNTAX score ≤32) to', '1893 patients with known smoking status at baseline, 416 (22%) were current smokers and 774 (41%) were former smokers']","['PCI versus CABG', 'Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting', 'PCI with everolimus-eluting stents or CABG']","['composite of death, myocardial infarction, or stroke', 'death, myocardial infarction, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",1905.0,0.0367596,"Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10).","[{'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Hôpital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Heart at Mount Sinai Saint Luke's, New York, New York.""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Horkay', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, NUIG, National University of Ireland, Galway, Ireland; Imperial College of Science, Technology and Medicine, London, United Kingdom.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.04.029'] 61,32369630,In situ decompression vs conservative treatment for mild ulnar neuropathy at the elbow.,"INTRODUCTION The best treatment strategy for mild ulnar neuropathy at the elbow (UNE) is not known, due to lack of trials comparing surgery vs conservative treatment. METHODS We recruited patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis. Patients were randomly allocated to either in situ decompression or conservative treatment. The primary outcome was the proportion of patients with subjective symptom improvement at short-term (3 months) and long-term (6-12 months) follow-up. RESULTS One hundred seventeen patients were included: 56 and 61 patients were allocated to surgery and conservative treatment, respectively. A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% vs 50%; odds ratio, 5.6; P < .001), but no differences were observed at long-term follow-up. DISCUSSION In situ decompression for mild UNE may result in faster relief of symptoms when compared with conservative treatment, but at long-term follow-up no differences were observed.",2020,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up. ","['Patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis were recruited', '117 patients were included: 56 and 61 patients']","['situ decompression or conservative treatment', 'situ decompression versus conservative treatment']","['relief of symptoms', 'proportion of patients with subjective symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.0474031,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up. ","[{'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Pompe', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Tobien', 'Initials': 'T', 'LastName': 'Schreuder', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Laurien L', 'Initials': 'LL', 'LastName': 'Teunissen', 'Affiliation': 'Department of Neurology, St. Antonius Ziekenhuis Nieuwegein, The Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beekman', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26912'] 62,32371430,"Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies.","BACKGROUND/OBJECTIVE FKB327 is a biosimilar of the antitumour necrosis factor adalimumab reference product (RP). A randomised, double-blind (DB) phase 3 study compared the efficacy of FKB327 with the RP in patients with active rheumatoid arthritis (RA) inadequately controlled with methotrexate (MTX). A subsequent randomised open-label extension (OLE) study with treatment switching assessed long-term safety, efficacy, pharmacokinetics and immunogenicity of FKB327 compared with the RP. METHODS Patients with moderate-to-severe, active RA on a stable dose of MTX were randomised 1:1 to receive FKB327 or the RP (40 mg subcutaneously every other week) for 24 weeks. Patients who completed the DB study were enrolled in the OLE and rerandomised 2:1 to receive FKB327 or the RP; two-thirds continued on the same treatment and one-third switched for 30 weeks. All patients received FKB327 through Week 76. Long-term efficacy, safety and immunogenicity were assessed. RESULTS Of 728 patients in the DB study, 645 were enrolled in the FKB327-OLE study. The American College of Rheumatology (ACR)20 response rates for all treatment groups at Week 30 in the OLE ranged from 83.2% to 85.9%. ACR20 response rates remained stable for all patients regardless of single- or double-switching treatment and were similar for all treatment sequences through Week 76. The safety profile and incidence of antidrug antibodies were comparable across sequences. CONCLUSION Efficacy, safety and immunogenicity were similar among patients with RA treated with FKB327 or the RP for up to 2 years, and were not affected by single- or double-switching treatment.",2020,ACR20 response rates remained stable for all patients regardless of single- or double-switching treatment and were similar for all treatment sequences through Week 76.,"['patients with active rheumatoid arthritis (RA', 'patients with active rheumatoid arthritis', '728 patients in the DB study', 'Patients who completed the DB study were enrolled in the OLE and rerandomised 2:1 to receive', 'Patients with moderate-to-severe, active RA on a stable dose of']","['FKB327 or the RP', 'MTX', 'methotrexate (MTX', 'FKB327']","['Long-term efficacy, safety and immunogenicity', 'ACR20 response rates', 'Rheumatology (ACR)20 response rates', 'safety and immunogenicity', 'safety profile and incidence of antidrug antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",645.0,0.211765,ACR20 response rates remained stable for all patients regardless of single- or double-switching treatment and were similar for all treatment sequences through Week 76.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Stanford University Medical Center, Palo Alto, California, USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Kellner', 'Affiliation': 'Specialist Practice in Rheumatology and Gastroenterology, Munich, Germany.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Fujifilm Kyowa Kirin Biologics, Tokyo, Japan.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Muniz', 'Affiliation': 'Mylan Inc., Canonsburg, Pennsylvania, USA.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'University Medicine Berlin, Berlin, Germany.'}]",RMD open,['10.1136/rmdopen-2019-000987'] 63,32371431,"Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naïve to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs: a matching-adjusted indirect comparison.","OBJECTIVE To compare improvement in pain and physical function for patients treated with baricitinib, adalimumab, tocilizumab and tofacitinib monotherapy from randomised, methotrexate (MTX)-controlled trials in conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)/biologic (bDMARD)-naïve RA patients using matching-adjusted indirect comparisons (MAICs). METHODS Data were from Phase III trials on patients receiving monotherapy baricitinib, tocilizumab, adalimumab, tofacitinib or MTX. Pain was assessed using a visual analogue scale (0-100 mm) and physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI). An MAIC based on treatment-arm matching, an MAIC with study-level matching and Bucher's method without matching compared change in outcomes between therapies. Matching variables included age, gender, baseline disease activity and baseline value of outcome measure. RESULTS With all methods, greater improvements were observed in pain and HAQ-DI at 6 months for baricitinib compared with adalimumab and tocilizumab ( p <0.05). Differences in treatment effects (TEs) favouring baricitinib for pain VAS for treatment-arm matching, study-level matching and Bucher's method, respectively, were -12, -12 and -12 for baricitinib versus adalimumab and -7, -7 and -9 for baricitinib versus tocilizumab; the difference in TEs for HAQ-DI was -0.28, -0.28 and -0.30 for adalimumab and -0.23, -0.23 and -0.26 for tocilizumab. For baricitinib versus tofacitinib, no statistically significant differences for pain improvement were observed except with one of the three methods (Bucher method) and none for HAQ-DI. CONCLUSIONS Results suggest greater pain reduction and improved physical function for baricitinib monotherapy compared with tocilizumab and adalimumab monotherapy. No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.",2020,No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.,"['patients treated with', 'Data were from Phase III trials on patients receiving', 'rheumatoid arthritis patients who are naïve to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs']","['monotherapy baricitinib, tocilizumab, adalimumab, tofacitinib or MTX', 'methotrexate (MTX)-controlled', 'tocilizumab', 'baricitinib, adalimumab, tocilizumab and tofacitinib monotherapy', 'adalimumab, tocilizumab and tofacitinib monotherapies', 'tocilizumab and adalimumab monotherapy']","['pain reduction and improved physical function', 'pain and physical function', 'physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI', 'visual analogue scale', 'Pain', 'pain and HAQ-DI', 'pain improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.107884,No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fautrel', 'Affiliation': 'Sorbonne University, Pierre Louis Institute for Epidemiology and Public Health; Assistance Publique Hopitaux de Paris, Pitie-Salpetriere University Hospital, Rheumatology Dept, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'Botnar Research Centre, Univ of Oxford, Headington, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van de Laar', 'Affiliation': 'University of Twente and Arthritis Center Twente, Enschede, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds MSK Biomed/Chapel Allerton Hosp, Leeds, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'De Leonardis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Kannowski', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nicolay', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Kadziola', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'De La Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Med Ctr, Dallas, Texas, USA.'}]",RMD open,['10.1136/rmdopen-2019-001131'] 64,32378975,Effect of neuromuscular electrical stimulation on skeletal muscle size and function in patients with breast cancer receiving chemotherapy.,"Exercise has numerous benefits for patients with cancer, but implementation is challenging because of practical and logistical hurdles. This study examined whether neuromuscular electrical stimulation (NMES) can serve as a surrogate for classic exercise by eliciting an exercise training response in skeletal muscle of women diagnosed with breast cancer undergoing chemotherapy. Patients ( n = 22) with histologically confirmed stage I, II, or III breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy were randomized to 8 wk of bilateral neuromuscular electrical stimulation (NMES; 5 days/wk) to their quadriceps muscles or control. Biopsy of the vastus lateralis was performed at baseline and after 8 wk of intervention to assess muscle fiber size, contractility, and mitochondrial content. Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses. NMES promoted muscle fiber hypertrophy ( P < 0.001), particularly in fast-twitch, myosin heavy chain (MHC) IIA fibers ( P < 0.05) and tended to induce fiber type shifts in MHC II fibers. The effects of NMES on single-muscle fiber contractility were modest, and it was unable to prevent declines in the function in MHC IIA fibers. NMES did not alter intermyofibrillar mitochondrial content/structure but was associated with reductions in subsarcolemmal mitochondria. Our results demonstrate that NMES induces muscle fiber hypertrophy and fiber type shifts in MHC II fibers but had minimal effects on fiber contractility and promoted reductions in subsarcolemmal mitochondria. Further studies are warranted to evaluate the utility of NMES as an exercise surrogate in cancer patients and other conditions. NEW & NOTEWORTHY This is the first study to evaluate whether neuromuscular electrical stimulation (NMES) can be used as an exercise surrogate to improve skeletal muscle fiber size or function in cancer patients receiving treatment. We show that NMES promoted muscle fiber hypertrophy and fiber type shifts but had minimal effects on single-fiber contractility and reduced subsarcolemmal mitochondria.",2020,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","['patients with cancer', 'Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses', 'Patients (n=22) with histologically-confirmed, stage I, II or III breast cancer scheduled to receive', 'women diagnosed with breast cancer undergoing chemotherapy', 'patients with breast cancer receiving chemotherapy']","['neuromuscular electrical stimulation', 'NMES', 'neuromuscular electrical stimulation (NMES', 'neoadjuvant or adjuvant chemotherapy', 'bilateral neuromuscular electrical stimulation (NMES; 5 days/week) to their quadriceps muscles or control', 'Exercise']","['fast-twitch, myosin heavy chain (MHC', 'skeletal muscle size and function', 'muscle fiber hypertrophy', 'subsarcolemmal mitochondria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0333759', 'cui_str': 'Muscle fiber hypertrophy'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}]",22.0,0.0485888,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Voigt', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Prior', 'Affiliation': 'Vermont Cancer Center, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Blas A', 'Initials': 'BA', 'LastName': 'Guigni', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Axel V', 'Initials': 'AV', 'LastName': 'Schlosberg', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Isaac B', 'Initials': 'IB', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Taylor J', 'Initials': 'TJ', 'LastName': 'Forest', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Wood', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Hibba', 'Initials': 'H', 'LastName': 'Rehman', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00203.2020'] 65,32375239,"A Novel Exercise for Enhancing Visuospatial Ability in Older Adults with Frailty: Development, Feasibility, and Effectiveness.","We aimed to develop a novel exercise to improve visuospatial ability and evaluate its feasibility and effectiveness in older adults with frailty. A non-randomized preliminary trial was conducted between June 2014 and March 2015. We recruited 35 adults with frailty (24 women), aged 66-92 years. Participants were assigned to either locomotive- or visuospatial-exercise groups. All participants exercised under the supervision of physiotherapists for 90 min/week for 12 weeks. The visuospatial exercise participants used cubes with six colored patterns and were instructed to ""reproduce the same colored pattern as shown in the photo"", using the cubes. In the locomotive exercise group, lower extremity functional training was provided. Rates of retention and attendance measured feasibility. Most participants completed the intervention (77.3%, locomotive; 84.6%, visuospatial) and had good attendance (83.8%, locomotive; 90.7%, visuospatial). Mini-mental state examination (MMSE), clock drawing test (CDT), and seven physical performance tests were conducted before and after interventions. The improvement in the MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments were significantly greater in the visuospatial exercise group than in the locomotive exercise group. The cube exercise might be a feasible exercise program to potentially improve visuospatial ability and global cognition in older adults with frailty.",2020,"The improvement in the MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments were significantly greater in the visuospatial exercise group than in the locomotive exercise group.","['Older Adults with Frailty', 'older adults with frailty', '35 adults with frailty (24 women), aged 66-92 years', 'June 2014 and March 2015', 'participants used cubes with six colored patterns']","['novel exercise', 'locomotive exercise', 'visuospatial exercise', 'locomotive- or visuospatial-exercise groups', 'Novel Exercise', 'Mini-mental state examination (MMSE), clock drawing test (CDT']","['Rates of retention and attendance measured feasibility', 'visuospatial ability and global cognition', 'lower extremity functional training', 'visuospatial ability and evaluate its feasibility and effectiveness', 'MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments', 'good attendance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0054696', 'cui_str': 'Carbohydrate deficient transferrin'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0054696', 'cui_str': 'Carbohydrate deficient transferrin'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",35.0,0.0340268,"The improvement in the MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments were significantly greater in the visuospatial exercise group than in the locomotive exercise group.","[{'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Nemoto', 'Affiliation': 'Dementia Medical Center, University of Tsukuba Hospital, Tsukuba 3058575, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 1730015, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Yabushita', 'Affiliation': 'Upten Health Support, Tsukuba 3050047, Japan.'}, {'ForeName': 'Keito', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'School of Health and Physical Education, University of Tsukuba, Tsukuba 3058577, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Occupational Therapy, Ibaraki Prefectural University of Health Sciences, Ami 3000394, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Occupational Therapy, Ibaraki Prefectural University of Health Sciences, Ami 3000394, Japan.'}, {'ForeName': 'Taeho', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba 3058577, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'Faculty of Human Sciences, Shimane University, Matsue 6900823, Japan.'}, {'ForeName': 'Tetsuaki', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba 3058575, Japan.'}, {'ForeName': 'Kiyoji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba 3058577, Japan.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5020029'] 66,32376984,"Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial Exercise, endothelium and blood pressure.","Endothelial dysfunction is a characteristic of systemic arterial hypertension (SAH) and an early marker of atherosclerosis. Aerobic exercise training (AT) improves endothelial function. However, the effects of resistance training (RT) and combined training (CT) on endothelial function remain controversial in individuals with SAH. We determined the effects of AT, RT, and CT on endothelial function and systolic (SBP)/diastolic blood pressure (DBP) in individuals with prehypertension or hypertension. Forty-two participants (54 ± 11 y, resting SBP/DBP 137 ± 9/86 ± 6 mmHg) were randomly allocated into AT (n = 14, 40 min of cycling, 50-75% heart rate reserve), RT (n = 14, 6 resistance exercises, 4 × 12 repetitions, 60% maximum strength) and CT (n = 14, 2 × 12 repetitions of RT + 20 min of AT). All participants performed a 40-minute exercise session twice a week for 8 weeks. Endothelial function was evaluated by brachial artery flow-mediated dilation (FMD). Blood pressure was evaluated through ambulatory monitoring for 24 hours. After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT. All 3 exercise training modalities produced similar improvements in FMD: + 3.2% (95%CI 1.7, 4.6) (p < 0.001) in AT; + 4.0% (95%CI 2.1, 5.7) (p < 0.001) in RT; and +6.8% (95%CI 2.6, 11.1) (p = 0.006) in CT. In conclusion, different exercise training modalities were similarly effective in improving endothelial function but impacts on ambulatory blood pressure appear to be variable in individuals with prehypertension or hypertension.",2020,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","['Forty-two participants (54\u2009±\u200911\u2009y, resting SBP/DBP 137\u2009±\u20099/86\u2009±\u20096\u2009mmHg', 'individuals with SAH', 'individuals with prehypertension or hypertension']","['AT, RT, and CT', '40-minute exercise session', 'exercise training modalities', 'Aerobic exercise training (AT', 'resistance training (RT) and combined training (CT']","['endothelial function', 'Endothelial function', 'blood pressure', 'endothelial function and systolic (SBP)/diastolic blood pressure (DBP', 'ambulatory blood pressure', 'brachial artery flow-mediated dilation (FMD', 'FMD', 'Blood pressure', 'endothelial function improvements']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.0337369,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-64365-x'] 67,32379637,Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study.,"BACKGROUND Different degrees of disorders are reported in respiratory function, physical function and psychological function in patients with corona virus disease 2019 (COVID-19), especially in elderly patients. With the experience of improved and discharged COVID-19 patients, timely respiratory rehabilitation intervention may improve prognosis, maximize functional preservation and improve quality of life (QoL), but there lacks of studies worldwide exploring the outcome of this intervention. OBJECTIVE To investigate the effects of 6-week respiratory rehabilitation training on respiratory function, QoL, mobility and psychological function in elderly patients with COVID-19. METHODS This paper reported the findings of an observational, prospective, quasi-experimental study, which totally recruited 72 participants, of which 36 patients underwent respiratory rehabilitation and the rest without any rehabilitation intervention. The following outcomes were measured: pulmonary function tests including plethysmography and diffusing lung capacity for carbon monoxide (DLCO), functional tests (6-min walk distance test), Quality of life (QoL) assessments (SF-36 scores), activities of daily living (Functional Independence Measure, FIM scores), and mental status tests (SAS anxiety and SDS depression scores). RESULTS After 6 weeks of respiratory rehabilitation in the intervention group, there disclosed significant differences in FEV1(L), FVC(L), FEV1/FVC%, DLCO% and 6-min walk test. The SF-36 scores, in 8 dimensions, were statistically significant within the intervention group and between the two groups. SAS and SDS scores in the intervention group decreased after the intervention, but only anxiety had significant statistical significance within and between the two groups. CONCLUSIONS Six-week respiratory rehabilitation can improve respiratory function, QoL and anxiety of elderly patients with COVID-19, but it has little significant improvement on depression in the elderly.",2020,"CONCLUSIONS Six-week respiratory rehabilitation can improve respiratory function, QoL and anxiety of elderly patients with COVID-19, but it has little significant improvement on depression in the elderly.","['elderly patients with COVID-19', '72 participants, of which 36 patients underwent respiratory rehabilitation and the rest without any rehabilitation intervention', 'patients with corona virus disease 2019 (COVID-19), especially in elderly patients']",['respiratory rehabilitation training'],"['SAS and SDS scores', 'quality of life (QoL', 'respiratory function, QoL, mobility and psychological function', 'respiratory function, QoL and anxiety', 'SF-36 scores', 'pulmonary function tests including plethysmography and diffusing lung capacity for carbon monoxide (DLCO), functional tests (6-min walk distance test), Quality of life (QoL) assessments (SF-36 scores), activities of daily living (Functional Independence Measure, FIM scores), and mental status tests (SAS anxiety and SDS depression scores', 'FEV1(L), FVC(L), FEV1/FVC%, DLCO% and 6-min walk test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0086571', 'cui_str': 'Lung Capacities'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3160837', 'cui_str': 'Walking distance test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",36.0,0.0321073,"CONCLUSIONS Six-week respiratory rehabilitation can improve respiratory function, QoL and anxiety of elderly patients with COVID-19, but it has little significant improvement on depression in the elderly.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatric Center, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, PR China.'}, {'ForeName': 'Weitong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, PR China.'}, {'ForeName': 'Yadong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medcine, Huanggang Central Hospital, Hubei Province. Huanggang, 438000, PR China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medcine, Huanggang Central Hospital, Hubei Province. Huanggang, 438000, PR China.'}, {'ForeName': 'Yunqian', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Geriatric Center, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Laboratory, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, China. Electronic address: hkchenying@126.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101166'] 68,32380138,Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy.,"Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​-0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.",2020,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","['patients suffering from chronic Low Back Pain (cLBP', 'healthy control adults (HC, N=50) and a large sample of cLBP patients (N=102) with']","['acupuncture', 'structural brain imaging (T1-weighted MRI for Voxel Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT', 'verum acupuncture', 'sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control']","['tactile acuity', 'S1-back adjacent white matter FA', '2PDT-back scores', 'Fractional Anisotropy (FA', 'tactile acuity over the back was improved (reduced 2PDT', 'reduced S1-back GMV', 'reduced acuity', 'Gray Matter Volume (GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",102.0,0.102659,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","[{'ForeName': 'Hyungjun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Mawla', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jeungchan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies & Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ""Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA. Electronic address: vitaly@mgh.harvard.edu.""}]",NeuroImage,['10.1016/j.neuroimage.2020.116899'] 69,32381562,Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.,"BACKGROUND The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA. METHODS C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare: ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period. RESULTS At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable. CONCLUSIONS Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal. TRIAL REGISTRATION NUMBER NCT02505542, ClinicalTrials.gov.",2020,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","['ASDAS) <1.3 at Weeks 32/36 and 48', 'patients with early axSpA.\nMETHODS', 'patients with axial spondyloarthritis (axSpA', 'adults with early active axSpA (radiographic or non-radiographic']","['CZP 200\u2009mg every 2 weeks (Q2W', 'CZP 200\u2009mg every 4 weeks (Q4W; reduced maintenance dose) or placebo', 'CZP 200\u2009mg Q2W', 'placebo']","['remaining flare-free (flare: ASDAS', 'sustained remission (Ankylosing Spondylitis Disease Activity Score', 'sustained remission', 'flare-free']","[{'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",,0.666024,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","[{'ForeName': 'Robert Bm', 'Initials': 'RB', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands landewe@rlandewe.nl.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Depertment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Herne, Germany.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Gaffney', 'Affiliation': 'Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Owen R', 'Initials': 'OR', 'LastName': 'Davies', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'de Peyrecave', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Gensler', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216839'] 70,32384205,The efficacy and safety of a 577-nm high-power optically pumped semiconductor laser in the treatment of postacne erythema.,"BACKGROUND Postacne erythema (PAE) is a common sequela of inflammatory acne vulgaris, treatment of which has been challenging due to limited options available and the variability of results for each modality. Recently, a 577-nm high-power optically pumped semiconductor laser (HOPSL) initially developed for vascular lesions has shown promising results for the treatment of PAE. AIMS To evaluate the efficacy and safety of 577-nm HOPSL in the treatment of postacne erythema. METHODS This was a split-face, randomized controlled trial pilot study. Twenty-one patients with PAE on both sides of their face were enrolled. Each subject's face sides were randomly assigned to either receive 577-nm HOPSL treatment (QuadroStar PRO™, Asclepion Laser Technologies) using the scanner handpiece, 1mm spot size, 80% coverage, 12-15 J/cm 2 , 30 ms, 2 passes for 3 sessions at 1-month intervals, or no treatment at all. Outcome measures such as overall improvement, the Erythema Index (EI), and Melanin Index (MI) from 3 different areas on both treatment and control sides were assessed at baseline, and 1-month follow-up after each treatment session. Side effects including pain, erythema, swelling, and crusting were also recorded. RESULTS Upon completion of the treatment period, the mean EI was significantly decreased in both treated and nontreated sides of the face (P < .001 and P = .001, respectively). The laser-treated sides already demonstrated significant reduction in the mean EI compared with nontreated sides at 1 month after the 2nd treatment (P = .007). The mean MI of both sides, however, did not show any statistically significant differences from baseline, and likewise when comparing between sides. Patients reported more improvement on laser-treated sides compared with nontreated sides. Reported side effects were limited to mild discomfort during treatment and transient facial erythema lasting approximately 30 minutes. CONCLUSION Patients who received treatment with the 577-nm HOPSL had better outcomes with minimal side effects at 1 month after 2 treatments as compared to those who did not receive any treatment. Therefore, the 577-nm HOPSL may be considered as an effective adjuvant treatment for PAE and early erythematous atrophic scars.",2020,The laser-treated sides already demonstrated significant reduction in the mean EI compared to non-treated sides at 1 month after the 2nd treatment (p=0.007).,"['Twenty-one patients with PAE on both sides of their face were enrolled', 'postacne erythema']","['577-nm high-power optically pumped semiconductor laser (HOPSL', '577-nm HOPSL', '577-nm HOPSL treatment (QuadroStar PRO TM , Asclepion Laser Technologies, Jena, Germany) using the scanner handpiece', '577-nm high-power optically pumped semiconductor laser']","['minimal side effects', 'overall improvement, the Erythema Index (EI) and Melanin Index (MI', 'mean MI of both sides', 'efficacy and safety', 'pain, erythema, swelling, and crusting', 'mean EI']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0181115', 'cui_str': 'Handpiece'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205204', 'cui_str': 'Crust'}]",21.0,0.0328977,The laser-treated sides already demonstrated significant reduction in the mean EI compared to non-treated sides at 1 month after the 2nd treatment (p=0.007).,"[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kathryn Anne G', 'Initials': 'KAG', 'LastName': 'Cembrano', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Ungaksornpairote', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Waritch', 'Initials': 'W', 'LastName': 'Kobwanthanakun', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Weeranut', 'Initials': 'W', 'LastName': 'Phothong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fritz', 'Affiliation': 'Dermatology and Laser Center, Landau, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Salavastru', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13474'] 71,32322920,"[Intensity-modulated fractionated radiotherapy vs. stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomized, open-label, phase 3, noninferiority trial].",,2020,,[],['Intensity-modulated fractionated radiotherapy vs. stereotactic body radiotherapy'],[],[],"[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}]",[],,0.0827106,,"[{'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': 'Strahlentherapie & Radioonkologie am Klinikum Coburg, Ketschendorfer Straße\xa033, 96450, Coburg, Deutschland. gg@diestrahlentherapeuten.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01616-w'] 72,32362346,An Assessment of Pharmacokinetic Interaction Between Lobeglitazone and Sitagliptin After Multiple Oral Administrations in Healthy Men.,"PURPOSE Patients with type 2 diabetes mellitus require strict blood glucose control, and combination therapy with a thiazolidinedione and dipeptidyl peptidase-4 inhibitors, such as lobeglitazone and sitagliptin, is one of the recommended treatments. The objective of this study was to investigate a possible pharmacokinetic interaction between lobeglitazone and sitagliptin after multiple oral administrations in healthy Korean men. METHODS Two randomized, open-label, multiple-dose, 2-way crossover studies were conducted simultaneously in healthy men. In study 1, men were randomly assigned to 1 of 2 sequences, and 1 of the following treatments was administered in each period: 1 tablet of lobeglitazone sulfate (0.5 mg) once daily for 5 days and or 1 tablet each of lobeglitazone sulfate (0.5 mg) and sitagliptin (100 mg) once daily for 5 days. In study 2, men were also randomly assigned to 1 of 2 sequences and the treatments were as follows: 1 tablet of sitagliptin (100 mg) once daily for 5 days or 1 tablet each of sitagliptin (100 mg) and lobeglitazone sulfate (0.5 mg) once daily for 5 days. Serial blood samples were collected up to 48 h after dosing on the fifth day. Plasma drug concentrations were measured by LC-MS/MS. Pharmacokinetic parameters, including C max,ss and AUC 0-τ , were determined by noncompartmental analysis. The geometric least-square mean (GLSM) ratios and associated 90% CIs of log-transformed C max,ss and AUC 0-τ for separate or coadministration were calculated to evaluate pharmacokinetic interactions. FINDINGS Nineteen men from study 1 and 17 from study 2 completed the pharmacokinetic sampling and were included in the analyses. The GLSM ratios of C max,ss and AUC 0-τ were 0.9494 (95% CI, 0.8798-1.0243) and 1.0106 (95% CI, 0.9119-1.1198) for lobeglitazone (from study 1) and 1.1694 (95% CI, 1.0740-1.2732) and 1.0037 (95% CI, 0.9715-1.0369) for sitagliptin (from study 2), respectively. IMPLICATIONS Except for the slight 17% increase in the sitagliptin C max,ss value, the pharmacokinetic parameters of lobeglitazone and sitagliptin met the pharmacokinetic equivalent criteria when administered separately or in combination. The increase in C max of sitagliptin when coadministered with lobeglitazone would not be clinically significant in practice. ClinicalTrials.gov Identifier: NCT02824874 and NCT02827890.",2020,"The GLSM ratios of C max,ss and AUC 0-τ were 0.9494 (95% CI, 0.8798-1.0243) and 1.0106 (95% CI, 0.9119-1.1198) for lobeglitazone (from study 1) and 1.1694 (95% CI, 1.0740-1.2732) and 1.0037 (95% CI, 0.9715-1.0369) for sitagliptin (from study 2), respectively. ","['healthy Korean men', 'Healthy Men', 'Patients with type 2 diabetes mellitus require strict blood glucose control, and combination therapy with a', 'healthy men', 'Nineteen men from study 1 and 17 from study 2 completed the pharmacokinetic sampling and were included in the analyses']","['thiazolidinedione and dipeptidyl peptidase-4 inhibitors, such as lobeglitazone and sitagliptin', 'lobeglitazone and sitagliptin', 'lobeglitazone', 'lobeglitazone sulfate', 'sitagliptin', 'Lobeglitazone and Sitagliptin']","['Serial blood samples', 'C max of sitagliptin', 'Pharmacokinetic parameters, including C max,ss and AUC 0-τ', 'GLSM ratios of C max,ss and AUC 0-τ', 'geometric least-square mean (GLSM) ratios', 'sitagliptin C max,ss value, the pharmacokinetic parameters', 'Plasma drug concentrations']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0450083,"The GLSM ratios of C max,ss and AUC 0-τ were 0.9494 (95% CI, 0.8798-1.0243) and 1.0106 (95% CI, 0.9119-1.1198) for lobeglitazone (from study 1) and 1.1694 (95% CI, 1.0740-1.2732) and 1.0037 (95% CI, 0.9715-1.0369) for sitagliptin (from study 2), respectively. ","[{'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Republic of Korea; Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University, Jeonju, Republic of Korea; Department of Pharmacology, School of Medicine, Jeonbuk National University, Jeonju, Republic of Korea. Electronic address: mgkim@jbnu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.005'] 73,32362510,Cluster Randomized Trial of a College Health Center Sexual Violence Intervention.,"INTRODUCTION Sexual violence, particularly in the context of drinking, is prevalent on college campuses. This study tested a brief intervention to prevent sexual violence among students receiving care from college health centers. STUDY DESIGN This study was a two-arm, unblinded cluster RCT. SETTING/PARTICIPANTS On 28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers completed surveys before the appointment, immediately after, 4 months later, and 12 months later. INTERVENTION Intervention college health center staff received training on delivering sexual violence education to all students seeking care. Control sites provided information about drinking responsibly. MAIN OUTCOME MEASURES The primary outcome was students' change in recognition of sexual violence. Additional outcomes included sexual violence disclosure and use of services among students with a history of sexual violence at baseline. Generalized linear mixed models accounting for campus-level clustering assessed intervention effects. Data were analyzed from September 2018 to June 2019. RESULTS Half (55%) of students seeking care at college health centers reported any history of sexual violence exposure. No between-group differences in primary (β=0.001, 95% CI= -0.04, 0.04) or secondary outcomes emerged between intervention and control students. Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants. Among those who reported sexual violence at baseline, intervention students had increased odds of disclosing violence during the visit (AOR=4.47, 95% CI=2.25, 8.89) in intensity-adjusted analyses compared with control. No between-group differences emerged for remaining outcomes. CONCLUSIONS Sexual violence exposure is high among students seeking care in college health centers. A brief provider-delivered sexual violence intervention, when implemented with fidelity, was associated with improved self-efficacy to use harm reduction and increased disclosure of sexual violence during clinical encounters but no increased use of services. More interventions that are stronger in intensity are needed to connect students to sexual violence services. TRIAL REGISTRATION This study is registered at www.clinicaltrials.gov NCT02355470.",2020,"Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants.","['Data were analyzed from September 2018 to June 2019', 'students seeking care in college health centers', 'students receiving care from college health centers', '28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers', 'College Health Center Sexual Violence Intervention']","['Intervention college health center staff received training on delivering sexual violence education to all students seeking care', 'sexual violence intervention']","[""students' change in recognition of sexual violence"", 'disclosing violence', 'sexual violence disclosure and use of services among students with a history of sexual violence', 'history of sexual violence exposure', 'self-efficacy', 'disclosure of sexual violence', 'sexual violence']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",2291.0,0.0525815,"Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Electronic address: elizabeth.miller@chp.edu.""}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'McCauley', 'Affiliation': 'School of Social Work, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Rofey', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Psychiatry, Western Psychiatric Hospital, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Duncan B', 'Initials': 'DB', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Talis', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Jocelyn C', 'Initials': 'JC', 'LastName': 'Anderson', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; College of Nursing, Pennsylvania State University, State College, Pennsylvania.""}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Chugani', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Robert W S', 'Initials': 'RWS', 'LastName': 'Coulter', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Behavioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.007'] 74,32363608,Development and preliminary validation of the Meaningful and Enjoyable Activities Scale (MEAS) in mild dementia.,"BACKGROUND Engaging in meaningful activity is an important contributor to well-being in late life. This study aimed to develop a new measure of meaningful and enjoyable activities in people living with mild dementia. METHODS The study consisted of four phases: (a) a review of measures of meaningful activity in older people; (b) interviews with people with dementia and their carers (n = 32), (c) expert opinion; and (d) feasibility testing in a pilot randomised controlled trial (n = 63). RESULTS The development process resulted in a 20-item questionnaire. The Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency (α = .79). Higher scores correlated with higher functional independence (r = -.605, P < .001), patient (r = .330, P = .010) and carer-rated patient quality of life (r = .505, P < .001). Multiple regression analyses showed that functional independence made a significant independent contribution in predicting higher levels of meaningful activity (F[7,45] = 6.75, P < .001, R 2 = .512; β = -.444, P = .001). Confirmatory factor analysis indicated that a revised three-factor 9-item model provided good fit for the data (X 2 = 22.74, P = .54, GFI = 0.93, RMSE = 0.00), with leisure-time physical activity, social engagement and mentally stimulating activities as the key dimensions. CONCLUSION Our study provides support for the construct of meaningful activity in people with mild dementia. Although we find preliminary evidence that the MEAS has adequate psychometric properties, future large scale studies are required to test its validity further and responsiveness to change.",2020,The Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency (α = 0.79).,"['people with mild dementia', 'mild dementia', 'older people; 2) interviews with people with dementia and their carers (n\xa0=\xa032', 'people living with mild dementia']",['MEAS'],"['carer-rated patient quality of life', 'functional independence', 'Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency', 'Meaningful and Enjoyable Activities Scale (MEAS', 'meaningful activity', 'leisure-time physical activity, social engagement and mentally stimulating activities']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0439073,The Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency (α = 0.79).,"[{'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Tuijt', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Phuong', 'Initials': 'P', 'LastName': 'Leung', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Profyri', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Orgeta', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}]",International journal of geriatric psychiatry,['10.1002/gps.5316'] 75,32374229,Acute acromioclavicular joint dislocation treated with tightrope : Mini-open versus percutaneous stabilization.,"The purpose of this study was to compare prospecti- vely the radiographic and clinical results of patients treated with tightrope through either mini-open or percutaneous stabilization for acute AC joint injuries. Eighty patients were included in this study and were randomly divided into two groups. Group A included 40 injuries treated with mini-open repair. Group B consisted of 40 injuries treated with percutaneous stabilization. Demographic and clinical data were comparable between the two groups before surgery (P>0.05). Peri-operative data, complications and clinical outcomes between the two groups were compared. The average follow-up time of Group A, was 26.5±4.3 months and Group B, was 25.2±5.6 months (P>0.05). The mean operative time was 63.2±9.6 minutes and 45.6±7.1 minutes, and the mean incision length was 6.0±1.5 cm and 4.0±0.8 cm, respectively. The operative time and incision length were significantly longer in Group A (both P<0.05). However, the radiological assessment revealed no significant difference in the coracoclavicular (CC) distance between the two groups (P>0.05). The rate of loss of reduction in the Group A was similar to that in Group B (6/40 vs. 5/40, P>0.05). Both methods were efficient methods for acute AC joint dislocation. However, percutaneous fixation had the advantages of a shorter surgical time and smaller incision length.",2019,The operative time and incision length were significantly longer in Group A (both P<0.05).,"['Acute acromioclavicular joint dislocation treated with', 'Eighty patients', 'patients treated with tightrope through either mini-open or percutaneous stabilization for acute AC joint injuries']","['percutaneous stabilization', 'mini-open repair', 'tightrope : Mini-open versus percutaneous stabilization', 'percutaneous fixation']","['surgical time and smaller incision length', 'coracoclavicular (CC) distance', 'Peri-operative data, complications and clinical outcomes', 'mean operative time', 'rate of loss of reduction', 'operative time and incision length', 'mean incision length']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149820', 'cui_str': 'Dislocation of acromioclavicular joint'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0409497', 'cui_str': 'Joint injury'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0441613', 'cui_str': 'Open repair of zygomatic fracture'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0441551', 'cui_str': 'Percutaneous fixation of bone'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0192608,The operative time and incision length were significantly longer in Group A (both P<0.05).,"[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Te', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Liao-Jun', 'Initials': 'LJ', 'LastName': 'Sun', 'Affiliation': ''}]",Acta orthopaedica Belgica,[] 76,32379102,Five Percent Monolaurin Vaginal Gel for the Treatment of Bacterial Vaginosis: A Randomized Placebo-Controlled Trial.,"OBJECTIVE The aim of the study was to test the hypothesis that 5% monolaurin vaginal gel, a naturally occurring monoglyceride shown to have antimicrobial effects on vaginal pathogens without affecting Lactobacillus species, cures bacterial vaginosis (BV). MATERIALS AND METHODS This was a multicenter, double-blinded, randomized controlled trial comparing 5% monolaurin vaginal gel to vehicle placebo (glycol-based) gel administered twice daily for 3 days. Nonpregnant, nonbreastfeeding women between ages 18 and 50 years were recruited and BV confirmed. Primary outcome was clinical cure assessed by resolution of all 4 Amsel criteria. Secondary outcomes included safety and tolerability assessed by solicited urogenital adverse events. Exploratory outcomes included colony counts for vaginal microbes associated with healthy vaginal flora (Lactobacillus species) and the dysbiosis often associated with BV (Gardnerella species and Mobiluncus species). A 2:1 test article to placebo randomization scheme was planned. RESULTS One hundred nine women participated with 73 randomized to the treatment arm and 36 to the placebo arm. There was no significant difference in clinical cure for BV (p = .42) with 17% of the monolaurin group and 25% of the placebo group achieving clinical cure. Lactobacilli species counts increased in the monolaurin group compared with placebo (1.0 × 10 vs -5.2 × 10). Two thirds of both groups reported solicited urogenital adverse events, but these were mild to moderate with no significant difference between groups (p = .24). CONCLUSIONS Monolaurin was no more clinically or microbiologically effective than placebo in curing BV. Future research should explore whether monolaurin may be used to increase Lactobacilli species.",2020,There was no significant difference in clinical cure for BV (p = .42) with 17% of the monolaurin group and 25% of the placebo group achieving clinical cure.,"['One hundred nine women participated with 73 randomized to the treatment arm and 36 to the', 'Bacterial Vaginosis', 'Nonpregnant, nonbreastfeeding women between ages 18 and 50 years were recruited and BV confirmed']","['Monolaurin Vaginal Gel', 'monolaurin vaginal gel to vehicle placebo (glycol-based) gel', 'Placebo', 'placebo']","['safety and tolerability assessed by solicited urogenital adverse events', 'solicited urogenital adverse events', 'clinical cure for BV', 'clinical cure', 'clinical cure assessed by resolution of all 4 Amsel criteria', 'colony counts for vaginal microbes associated with healthy vaginal flora (Lactobacillus species) and the dysbiosis often associated with BV (Gardnerella species and Mobiluncus species', 'microbiologically effective', 'Lactobacilli species counts']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0066761', 'cui_str': 'monolaurin'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017951', 'cui_str': 'Glycol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0326863', 'cui_str': 'Blackbird'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0085487', 'cui_str': 'Gardnerella'}, {'cui': 'C0206385', 'cui_str': 'Mobiluncus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",109.0,0.786775,There was no significant difference in clinical cure for BV (p = .42) with 17% of the monolaurin group and 25% of the placebo group achieving clinical cure.,"[{'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Mancuso', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'Lea E', 'Initials': 'LE', 'LastName': 'Widdice', 'Affiliation': ""Division of Adolescent and Transition Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Brenna L', 'Initials': 'BL', 'LastName': 'Hughes', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schlievert', 'Affiliation': 'Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'Stockdale', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Division of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Winokur', 'Affiliation': 'Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.'}]",Journal of lower genital tract disease,['10.1097/LGT.0000000000000543'] 77,32376326,Family History Influences the Effectiveness of Home Exercise in Older People With Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE To investigate whether a family history of low back pain (LBP) influences patient outcomes and treatment effects following home exercises in older people with chronic LBP. DESIGN Secondary analysis of a randomized controlled trial. SETTING Local community. PARTICIPANTS People older than 55 years with chronic LBP (N=60). INTERVENTIONS Participants in the intervention group completed video game exercises for 60 minutes 3 times per week for 8 weeks. Participants in the control group were instructed to maintain their usual levels of activity and care seeking behaviors. MAIN OUTCOMES MEASURES Participants indicated whether any of their immediate family members had a history of ""any"" LBP or ""activity-limiting"" LBP at baseline. We collected self-reported measures of pain, function, pain self-efficacy, care seeking, physical activity, disability, fear of movement and/or reinjury, and falls efficacy at baseline, 8 weeks, 3 months, and 6 months. We performed regression analyses to determine whether a family history of LBP predicted patient outcomes and moderated the effects of home exercise. RESULTS Participants with a family history of any LBP were less likely to be highly active than those without a family history (odds ratio, 0.08; 95% CI, 0.01-0.42; P=.003). Home-based video game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78; 95% CI, 0.56-3.00; P=.006) but not in those with a family history (β=-0.17; 95% CI, -2.56 to 2.21; P=.880) (interaction P=.049). A family history of LBP did not influence the remaining patient outcomes or treatment effects. CONCLUSIONS A family history of LBP appears to negatively influence physical activity levels in older people with chronic LBP. Further, home-based video game exercises appear to be beneficial for older people with chronic LBP that do not have a family history of LBP.",2020,"Home-based video-game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78 95%CI: 0.56-3.00, p=0.006), but not in those with a family history (β=-0.17 95%CI: -2.56 to 2.21, p=0.880) (interaction p=0.049).","['older people with chronic LBP', 'Local community', 'People over 55 years old with chronic LBP', 'OF HOME-EXERCISE IN OLDER PEOPLE WITH CHRONIC LOW BACK PAIN']","['home-exercises', 'video-game exercises']","['pain, function, pain self-efficacy, care seeking, physical activity, disability, fear of movement/re-injury, and falls-efficacy', ""history of 'any' LBP or 'activity-limiting' LBP"", 'physical activity levels']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0788307,"Home-based video-game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78 95%CI: 0.56-3.00, p=0.006), but not in those with a family history (β=-0.17 95%CI: -2.56 to 2.21, p=0.880) (interaction p=0.049).","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Zadro', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, NSW, Australia. Electronic address: joshua.zadro@sydney.edu.au.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Shirley', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, NSW, Australia.'}, {'ForeName': 'Tom I L', 'Initials': 'TIL', 'LastName': 'Nilsen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway; Clinic of Anaesthesia and Intensive Care, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, NSW, Australia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.019'] 78,32376347,A pragmatic randomized trial of cardiopulmonary resuscitation training for families of cardiac patients before hospital discharge using a mobile application.,"AIM OF THE STUDY Since over 80% of sudden cardiac arrests occur in the home, cardiopulmonary resuscitation (CPR) training for family members of high-risk cardiac patients represents a promising intervention. The use of mobile application-based (mApp) CPR training may facilitate this approach, but evidence regarding its efficacy is lacking. METHODS We conducted a multicenter, pragmatic, cluster-randomized trial assessing CPR training for family members of cardiac patients. The interventions were mApp (video, no manikin) and VSI (video + manikin). CPR skills were evaluated 6-months post-training. We hypothesized that chest compression (CC) rate from training with an mApp would be no worse than 5 compressions per minute (CPM) lower compared to VSI. RESULTS From 01/2016 to 01/2018, we enrolled 1325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white). CPR skills were evaluated 6-months post-training in 541 participants (275 VSI, 266 mApp). Mean rate was 84.6 CPM (95% CI: 80.4, 88.6) in VSI, compared to 82.7 CPM (95% CI: 76.2, 89.1) in the mApp, and mean depth was 42.1 mm (95% CI: 40.3, 43.8) in VSI, compared to 38.9 mm (95% CI: 36.2, 41.6) in the mApp. After adjustment, the mean difference in CC rate was -2.3 CPM (95% CI -9.4, 4.8, p = 0.25, non-inferiority) and CC depth was -3.2 mm (95% CI -5.9, 0.1, p = 0.056). CONCLUSION In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality. Future work is required to understand additional approaches to improve CPR skill retention. CLINICAL TRIAL REGISTRATION URL: ClinicalTrials.gov, Identifier: NCT02548793.",2020,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","['1,325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white', 'family members of cardiac patients', 'family members of high-risk cardiac patients', 'families of cardiac patients before hospital discharge using a mobile application']","['CPR training', 'cardiopulmonary resuscitation (CPR) training', 'cardiopulmonary resuscitation training', 'mobile application-based (mApp) CPR training']","['CPR skills', 'CC rate', 'Mean rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1325.0,0.173811,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","[{'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Blewer', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA. Electronic address: Audrey.blewer@duke.edu.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'McGovern', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA.'}, {'ForeName': 'Raina M', 'Initials': 'RM', 'LastName': 'Merchant', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2020.04.026'] 79,32380239,Effects of Partial Sleep Deprivation on Braking Response of Drivers in Hazard Scenarios.,"This study aimed at modeling the Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD). Fifty male participants drove the driving simulator in three experimental conditions: two test sessions and a baseline. The two test sessions were conducted after one and two nights of PSD (sleep = 4.25 ± 0.5 h), respectively. Sleep reduction was recorded using a wrist-worn Actiwatch. The baseline session was conducted after full rest (7-8 h sleep/day for a week). The order of test sessions and baseline was randomized. Each test included two hazard events: 1) pedestrians crossing a road and 2) parked vehicles merging into a roadway. Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings were also recorded during each drive. Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events. The models were chosen with clustered heterogeneity to account for intra-group heterogeneity due to repeated measures across tests. In the case of pedestrians crossing event, RT increased by 10% in the first test session and no significant effect observed on RT in the second test session. The overall TBT reduced by 25% and 28% during the first and second PSD sessions, respectively. In the case of vehicle merging event, both response time and total braking time delayed by 44% and 17% respectively after PSD. Other factors such as age, experience, work-rest hours, KSS and SSQ rating, often exercising, approaching speed and braking force were also found significant in the analysis. The parametric AFT approach adopted in this study showed the change in 'response time' and 'total braking time' concerning the type of hazard scenario and partial sleep-deprivation.",2020,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"['Fifty male participants', 'Drivers in Hazard Scenarios']",['Partial Sleep Deprivation'],"['Sleep reduction', 'response time and total braking time delayed', 'pedestrians crossing a road and 2) parked vehicles merging into a roadway', 'Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings', 'overall TBT', 'Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",50.0,0.023591,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Mahajan', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India.'}, {'ForeName': 'Nagendra R', 'Initials': 'NR', 'LastName': 'Velaga', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India. Electronic address: n.r.velaga@iitb.ac.in.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105545'] 80,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3'] 81,32386747,Effect of immune regulatory pathways after immunization with GMZ2 malaria vaccine candidate in healthy lifelong malaria-exposed adults.,"BACKGROUND Despite appreciable immunogenicity in malaria-naive populations, many candidate malaria vaccines are considerably less immunogenic in malaria-exposed populations. This could reflect induction of immune regulatory mechanisms involving Human Leukocyte Antigen G (HLA-G), regulatory T (Treg), and regulatory B (Breg) cells. Here, we addressed the question whether there is correlation between these immune regulatory pathways and both plasmablast frequencies and vaccine-specific IgG concentrations. METHODS Fifty Gabonese adults with lifelong exposure to Plasmodium spp were randomized to receive three doses of either 30 µg or 100 µg GMZ2-CAF01, or 100 µg GMZ2-alum, or control vaccine (rabies vaccine) at 4-week intervals. Only plasma and peripheral blood mononuclear cells isolated from blood samples collected before (D0) and 28 days after the third vaccination (D84) of 35 participants were used to measure sHLA-G levels and anti-GMZ2 IgG concentrations, and to quantify Treg, Breg and plasmablast cells. Vaccine efficacy was assessed using controlled human malaria infection (CHMI) by direct venous inoculation of Plasmodium falciparum sporozoites (PfSPZ Challenge). RESULTS The sHLA-G concentration increased from D0 to D84 in all GMZ2 vaccinated participants and in the control group, whereas Treg frequencies increased only in those receiving 30 µg or 100 µg GMZ2-CAF01. The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies. Importantly, having a D84:D0 ratio of sHLA-G above the median was associated with an increased risk of P. falciparum infection after sporozoites injection. CONCLUSION Regulatory immune responses are induced following immunization. Stronger sHLA-G and Treg immune responses may suppress vaccine induced immune responses, and the magnitude of the sHLA-G response increased the risk of Plasmodium falciparum infection after CHMI. These findings could have implications for the design and testing of malaria vaccine candidates in semi-immune individuals.",2020,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","['Fifty Gabonese adults with lifelong exposure to Plasmodium spp', 'healthy lifelong malaria-exposed adults']","['30\xa0µg or 100\xa0µg GMZ2-CAF01, or 100\xa0µg GMZ2-alum, or control vaccine (rabies vaccine', 'GMZ2 malaria vaccine candidate']","['Vaccine efficacy', 'sHLA-G levels and anti-GMZ2 IgG concentrations', 'anti-GMZ2 IgG concentration', 'Only plasma and peripheral blood mononuclear cells', 'sHLA-G concentration', 'risk of P. falciparum infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",35.0,0.0706217,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","[{'ForeName': 'Odilon', 'Initials': 'O', 'LastName': 'Nouatin', 'Affiliation': ""Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: paterneodilon@gmail.com.""}, {'ForeName': 'Ulysse', 'Initials': 'U', 'LastName': 'Ateba Ngoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon. Electronic address: ulyssus7000@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Dejon-Agobe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: benjamin.mordmueller@uni-tuebingen.de.'}, {'ForeName': 'Jean Ronald', 'Initials': 'JR', 'LastName': 'Edoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: j.ronaldedoa@cermel.org.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Mougeni', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Brückner', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: sinab@gmx.net.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Bouyoukou Hounkpatin', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: meral.esen@uni-tuebingen.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Theisen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark and Centre for Medical Parasitology at Department of International Health, Immunology and Microbiology, University of Copenhagen, and Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark. Electronic address: mth@ssi.dk.'}, {'ForeName': 'Kabirou', 'Initials': 'K', 'LastName': 'Moutairou', 'Affiliation': ""Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: kamoutairo@yahoo.fr.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc, Rockville, MD 20850, USA. Electronic address: slhoffman@sanaria.com.'}, {'ForeName': 'Saadou', 'Initials': 'S', 'LastName': 'Issifou', 'Affiliation': 'Fondation pour la Recherche Scientifique, 72 BP45 Cotonou, Benin. Electronic address: isaadou2002@yahoo.fr.'}, {'ForeName': 'Adrian J F', 'Initials': 'AJF', 'LastName': 'Luty', 'Affiliation': ""Centre d'Etude et de Recherche sur le Paludisme Associé à la Grossesse et à l'Enfance, Faculté des Sciences de la Santé, Université d'Abomey-Calavi, Cotonou, MERIT UMR D216, Benin; Université de Paris, MERIT, IRD, Paris, France. Electronic address: adrian.luty@ird.fr.""}, {'ForeName': 'Marguerite M', 'Initials': 'MM', 'LastName': 'Loembe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: mmassingaloembe@cermel.org.'}, {'ForeName': 'Selidji Todagbé', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: agnandjis@cermel.org.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: bertrand.lell@cermel.org.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}, {'ForeName': 'Ayôla Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Leiden University Medical Centre (LUMC), 2333 ZA Leiden, the Netherlands. Electronic address: aadegnika@cermel.org.'}]",Vaccine,['10.1016/j.vaccine.2020.04.046'] 82,32332564,"The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.",,2020,,['after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",['Transversus Abdominis Plane Block'],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.200618,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic Division of Plastic Surgery, MetroHealth Department of Plastic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782'] 83,32360392,A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder.,"BACKGROUND This study was a randomized double-blind sham-controlled trial examining the effects of transcranial direct current stimulation (tDCS) augmented cognitive training (CT) in children with Fetal Alcohol Spectrum Disorders (FASD). Prenatal alcohol exposure has profound detrimental effects on brain development and individuals with FASD commonly present with deficits in executive functions including attention and working memory. The most commonly studied treatment for executive deficits is CT, which involves repeated drilling of exercises targeting the impaired functions. As currently implemented, CT requires many hours and the observed effect sizes are moderate. Neuromodulation via tDCS can enhance brain plasticity and prior studies demonstrate that combining tDCS with CT improves efficacy and functional outcomes. TDCS-augmented CT has not yet been tested in FASD, a condition in which there are known abnormalities in neuroplasticity and few interventions. METHODS This study examined the feasibility and efficacy of this approach in 44 children with FASD. Participants were randomized to receive five sessions of CT with either active or sham tDCS targeting the dorsolateral prefrontal cortex, a region of the brain that is heavily involved in executive functioning. RESULTS The intervention was feasible and well-tolerated in children with FASD. The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p = .043). Group differences were observed at the third, fourth and fifth treatment sessions. There was no effect of tDCS on working memory (p = .911). Further, we found no group differences on a trail making task (p = .659) or on the verbal fluency test (p = .826). In the active tDCS group, a significant correlation was observed between improvement in attention scores and decrease in parent-reported attention deficits (p = .010). CONCLUSIONS These results demonstrate that tDCS-augmented CT is well tolerated in children with FASD and potentially offers benefits over and above CT alone.",2020,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"['children with fetal alcohol spectrum disorder', 'children with Fetal Alcohol Spectrum Disorders (FASD', 'children with FASD', '44 children with FASD']","['CT with either active or sham tDCS', 'transcranial direct current stimulation (tDCS) augmented cognitive training (CT', 'transcranial direct-current stimulation and cognitive training', 'tDCS', 'tDCS-augmented CT', 'CT', 'TDCS-augmented CT']","['feasibility and efficacy', 'trail making task', 'attention scores and decrease in parent-reported attention deficits', 'attention on a continuous performance test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",44.0,0.0938664,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Boroda', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Krueger', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'University of Maryland, USA.'}, {'ForeName': 'Mariah J', 'Initials': 'MJ', 'LastName': 'Schumacher', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Abhrajeet V', 'Initials': 'AV', 'LastName': 'Roy', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boys', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Wozniak', 'Affiliation': 'University of Minnesota, Twin Cities, USA. Electronic address: jwozniak@umn.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.04.015'] 84,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS People with type 2 diabetes (T2D) have a greater prevalence of musculoskeletal and neuropathic pain. This exploratory analysis investigated whether exercise of different intensities leads to changes in self-reported musculoskeletal pain or symptoms of diabetic neuropathy in inactive individuals with type 2 diabetes. METHODS Thirty-two inactive adults with T2D (59% male, mean age 58.7 ± 9.1yrs, median HbA 1c 7.8%) were randomised to usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT). At baseline and 8-weeks, musculoskeletal and neuropathic pain were evaluated using a modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively. Quantitative sensory testing was used to determine thermal, mechanical and vibration detection thresholds, as well as pain pressure thresholds. Adverse events were recorded throughout the intervention. RESULTS Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [-10.6 to -0.2], p = 0.04) and non-significantly greater for C-MICT (MD -5.9 [-12.4 to 0.7], p = 0.08). Changes in neuropathy symptoms were not different between C-HIIT and CON (MD 1.0 [-0.9 to 2.8], p = 0.31), or C-MICT and CON (MD 0.2 [-3.1 to 3.6], p = 0.89). No differences in sensory function were observed between groups. Similar rates of adverse events were seen in both exercise interventions (19 C-HIIT; 17 C-MICT), all but one of which were mild. CONCLUSIONS Preliminary data suggests 8-weeks of high-intensity combined aerobic and resistance exercise may be safely prescribed for inactive individuals with T2D and may reduce musculoskeletal pain but not neuropathic symptoms. TRIAL REGISTRATION ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c 7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168'] 85,32313980,Dopaminergic and noradrenergic manipulation of anticipatory reward and probability event-related potentials.,"Predicting what will happen in the future in terms of potential reward is essential in daily life. The aim of the current study was to investigate the neurotransmitter systems involved in the anticipation of reward value and probability. We hypothesized that dopaminergic and noradrenergic antagonism would affect anticipation of reward value and probability, respectively. Twenty-three healthy participants were included in a haloperidol (2 mg) × clonidine (0.150 mg) × placebo cross-over design and subjected to a Go/NoGo experimental task during which cues signaled the probability of subsequent target appearance. Reward value (amount of money that could be won for correct and fast responding to the target) as well as probability of target appearance was orthogonally manipulated across four task blocks. Cue-elicited EEG event-related potentials were recorded to assess anticipation of value and probability, respectively. The processing of reward value was affected by dopaminergic antagonism (haloperidol), as evidenced by reduction of the reward-related positivity and P300 to reward cues. This reduction was specifically significant for subjects with high baseline dopamine levels for the P300 and most pronounced for these subjects for the reward-related positivity. In contrast, the processing of reward probability was affected by noradrenergic antagonism (clonidine). In addition, both drugs reduced overall performance (omission rate, response speed variability). We conclude that at least anticipation of reward value and probability, respectively, is specifically affected by dopaminergic versus noradrenergic antagonism.",2020,"The processing of reward value was affected by dopaminergic antagonism (haloperidol), as evidenced by reduction of the reward-related positivity and P300 to reward cues.",['Twenty-three healthy participants were included in a haloperidol (2\xa0mg'],['clonidine'],"['overall performance (omission rate, response speed variability']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",23.0,0.109887,"The processing of reward value was affected by dopaminergic antagonism (haloperidol), as evidenced by reduction of the reward-related positivity and P300 to reward cues.","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Schutte', 'Affiliation': 'Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands. iris.schutte2706@gmail.com.'}, {'ForeName': 'Peter K H', 'Initials': 'PKH', 'LastName': 'Deschamps', 'Affiliation': 'Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'van Harten', 'Affiliation': 'Department of Psychiatry and Psychology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'J Leon', 'Initials': 'JL', 'LastName': 'Kenemans', 'Affiliation': 'Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05515-x'] 86,32376724,"Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210) for advanced osteosarcoma (APFAO) progressing after chemotherapy: a single-arm, open-label, phase 2 trial.","BACKGROUND Results of our previous study showed high objective response but short-term activity of apatinib in advanced osteosarcoma. We aimed to investigate the activity of apatinib in combination with camrelizumab in patients with inoperable high-grade osteosarcoma progressing after chemotherapy. METHODS This open-label, phase 2 trial was conducted at Peking University People's Hospital. We enrolled patients with advanced osteosarcoma progressed after chemotherapy. Patients received 500 mg apatinib orally once daily plus 200 mg camrelizumab by intravenous infusion every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) and clinical benefit rate at 6 months, which were based on RECIST V.1.1. RESULTS 43 patients were enrolled between January 25 and September 4, 2018. With median follow-up time of 48.3 (Q1, Q3, 30.6, 66.6) weeks, 13 (30.23%, 95% CI 17.2%, 40.1%) of 43 patients were progression free at 6 months and the 6-month PFS rate was 50.9% (95% CI 34.6%, 65.0%). Until final follow-up, the objective response rate was 20.9% (9/43) and two patients with durable disease control were observed. Patients with programmed cell death 1 ligand-1 (PD-L1) tumor proportion score ≥5% and pulmonary metastases tended to have a longer PFS in comparison to the others (p=0.004 and 0.017, respectively). Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients. There were no treatment-related deaths. CONCLUSIONS Although the combination of apatinib and camrelizumab seemed to prolong PFS in comparison to single agent apatinib in treating advanced osteosarcoma, it did not reach the prespecified target of 6-month PFS of 60% or greater. Overexpression of PD-L1 and the presence of pulmonary metastases only were associated with longer PFS. TRIAL REGISTRATION NUMBER NCT03359018.",2020,"Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients.","['Patients with programmed cell death 1 ligand-1 (PD-L1', ""Peking University People's Hospital"", '43 patients were enrolled between January 25 and September 4, 2018', 'enrolled patients with advanced osteosarcoma progressed after chemotherapy', 'patients with inoperable high-grade osteosarcoma progressing after chemotherapy', 'advanced osteosarcoma (APFAO) progressing after chemotherapy']","['Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210', '500\u2009mg apatinib orally once daily plus 200\u2009mg camrelizumab', 'camrelizumab']","['Toxic effects', 'progression free', '6-month PFS rate', 'Overexpression of PD-L1 and the presence of pulmonary metastases', 'objective response rate', 'progression-free survival (PFS) and clinical benefit rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4552121', 'cui_str': 'SHR-1210'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",43.0,0.208514,"Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China bonetumor@163.com.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Surgical Oncology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Kuisheng', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Bingxin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Ren', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Taiqiang', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kunkun', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': ""Pathology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Danhua', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': ""Pathology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Radiology Department & Nuclear Medicine Department, Peking University People's Hospital, Beijing, China.""}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000798'] 87,32382415,Effect of procalcitonin on the prognosis of patients with COPD.,"The aim of the present study was to investigate the effect of procalcitonin levels on the prognosis of chronic obstructive pulmonary disease (COPD), and its relationship with other indices of infection. Inpatients diagnosed with acute aggravation of COPD between January 2017 and June 2018 were enrolled in the present study. Troponin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), white blood cell (WBC) count, percentage of neutrophils (NE%), hospitalization days and hospitalization expenses were collected and followed up for half a year to observe the survival rate in patients with COPD and the risk of acute aggravation. There were 246 patients with procalcitonin (PCT) levels <0.1 ng/ml, among whom 55 were randomly selected and assigned to a PCT negative group; and another 55 patients with PCT levels ≥0.1 ng/ml were assigned to a PCT positive group. The serum CRP, ESR, WBC count, NE% and hospitalization expenses in the PCT positive group were significantly higher compared with the PCT negative group (P<0.05). There was a positive association between PCT levels and CRP, WBC, NE% and hospitalization expenses, but not between PCT and ESR. The number of AECOPD events occurring within half a year between the two groups was statistically significant (χ²=5.923; P<0.05), and there was no significant correlation between PCT and recurrence frequency. Together, the results of the present study suggest that the levels of PCT in patients with acute aggravation may reflect the severity of COPD and may be used as a reference value for prognostic risk assessment. Serum PCT levels may be used as an indicator to predict duration and cost of hospitalization.",2020,"The serum CRP, ESR, WBC count, NE% and hospitalization expenses in the PCT positive group were significantly higher compared with the PCT negative group (P<0.05).","['Inpatients diagnosed with acute aggravation of COPD between January 2017 and June 2018 were enrolled in the present study', '246 patients with procalcitonin (PCT) levels <0.1 ng/ml, among whom 55 were randomly selected and assigned to a PCT negative group; and another 55 patients with PCT levels', 'patients with COPD']",['procalcitonin'],"['number of AECOPD events', 'PCT levels and CRP, WBC, NE% and hospitalization expenses', 'Troponin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), white blood cell (WBC) count, percentage of neutrophils (NE%), hospitalization days and hospitalization expenses', 'survival rate', 'Serum PCT levels', 'chronic obstructive pulmonary disease (COPD', 'serum CRP, ESR, WBC count, NE% and hospitalization expenses']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",246.0,0.0257163,"The serum CRP, ESR, WBC count, NE% and hospitalization expenses in the PCT positive group were significantly higher compared with the PCT negative group (P<0.05).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}, {'ForeName': 'Minli', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}, {'ForeName': 'Zhengfu', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}]",Biomedical reports,['10.3892/br.2020.1298'] 88,32394643,Accuracy and Safety of Robot-Assisted Drilling Decompression for Osteonecrosis of the Femoral Head.,"OBJECTIVE To investigate the safety and superiority of robot-assisted femoral head drilling decompression in the treatment of femoral head necrosis. METHODS A total of 63 patients who underwent borehole decompression of the femoral head in our hospital from January 2016 to March 2019 were recruited. Patients were divided into two groups for comparison according to surgical methods. In the robot-assisted surgery group, there were 30 cases with 41 femoral heads. The conventional group had 33 cases and 46 femoral heads. All patients signed the consent form before the operation. The follow-up time was 6 months. The incision lengths, operation times, intraoperative blood loss, intraoperative fluoroscopies, guide needle punctures, postoperative Harris scores, and postoperative complications of the two groups were compared. RESULTS The incision length of the robot surgery group was 5.16 ± 0.41 cm, while that of the traditional surgery group was 7.42 ± 0.50 cm. The operation time of the robot surgery group was 46.99 ± 4.94 min, while that of the traditional surgery group was 55.01 ± 6.19 min. The fluoroscopy frequency of the robot surgery group was 10.50 ± 1.78 times, while that of the traditional surgery group was 17.91 ± 2.20 times. The intraoperative blood loss in the robotic surgery group was 20.62 ± 2.52 mL, while that in the conventional surgery group was 52.72 ± 3.39 mL. In the robot operation group, each femoral head guide needle was punctured three times, and the puncture was successful one time. The number of guided needle punctures in the traditional group was 8.02 ± 1.73. The difference between the two groups was statistically significant (P < 0.05). The Harris score was 69.53 ± 7.51 in the robot surgery group and 68.38 ± 7.26 in the traditional surgery group one month after surgery, 78.52 ± 6.49 in the robot surgery group and 76.41 ± 7.95 in the traditional surgery group three months after surgery, and 83.32 ± 8.62 in the robot surgery group and 81.74 ± 6.20 in the traditional surgery group six months after surgery. There was no significant difference between the two groups (P > 0.05). In the traditional group, there was one case of incision infection and one case of femoral head collapse during follow-up. In the robot group, there were no complications, such as incision infection and deep vein thrombosis. No collapse of the femoral head was found in the robot group during follow-up. CONCLUSION The positioning system of the orthopaedic robot is an ideal method for the treatment of femoral head necrosis. This method has the advantages of simple operation, accurate drilling, a short operation time, less surgical trauma, less radioactivity, and good recovery of hip joint function.",2020,"In the traditional group, there was one case of incision infection and one case of femoral head collapse during follow-up.","['Osteonecrosis of the Femoral Head', '30 cases with 41 femoral heads', '63 patients who underwent borehole decompression of the femoral head in our hospital from January 2016 to March 2019 were recruited']","['robot-assisted femoral head drilling decompression', 'Robot-Assisted Drilling Decompression']","['number of guided needle punctures', 'incision infection and deep vein thrombosis', 'incision lengths, operation times, intraoperative blood loss, intraoperative fluoroscopies, guide needle punctures, postoperative Harris scores, and postoperative complications', 'incision infection', 'collapse of the femoral head', 'incision length', 'fluoroscopy frequency', 'intraoperative blood loss', 'femoral head collapse', 'operation time']","[{'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",63.0,0.0163949,"In the traditional group, there was one case of incision infection and one case of femoral head collapse during follow-up.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Ya-Jing', 'Initials': 'YJ', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Long', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Lan', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Kai-Nan', 'Initials': 'KN', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}]",Orthopaedic surgery,['10.1111/os.12678'] 89,32334996,"Erratum to ""Chart for renal tumor microwave ablation from human study"" [Diagn. Interv. Imaging 99 (2018) 609-14].",,2020,,['Imaging 99 (2018'],[],[],"[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],[],,0.0133815,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Noventa', 'Affiliation': 'Department of Radiology, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Herpe', 'Affiliation': 'Department of Radiology, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vesselle', 'Affiliation': 'Department of Radiology, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guibal', 'Affiliation': 'Department of radiology, Centre hospitalier de Perpignan, 66100 Perpignan, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Velasco', 'Affiliation': 'Department of Radiology, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ingrand', 'Affiliation': 'Epidemiology, biostatistics, INSERM CIC 1402, University of Medicine, University Hospital, 86000 Poitiers, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boucebci', 'Affiliation': 'Department of Radiology, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Tasu', 'Affiliation': ""Department of Radiology, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France; University of Poitiers, 15, rue de l'Hôtel-Dieu, 86000 Poitiers, France. Electronic address: Jean-pierre.tasu@chu-poitiers.fr.""}]",Diagnostic and interventional imaging,['10.1016/j.diii.2019.12.010'] 90,32369401,Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105.,"PURPOSE Nonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions. METHODS We conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed. RESULTS In total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4% v 10.3%; HR, 1.16 [95% CI, 0.69 to 1.98]; P = .57) and site-reported time to AF (21.9% v 18.9%; HR, 1.31 [95% CI, 0.86 to 2.01]; P = .21) also did not differ by arm. CONCLUSION To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.",2020,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18).","['Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months', 'Women', '724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline']","['text messaging (TM) versus no text messaging (No-TM', 'Adjuvant Aromatase Inhibitor Therapy', 'Text Messaging']","['time to AF', 'time to adherence failure (AF', 'rates of AI AF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",724.0,0.166451,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18).","[{'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Grace Clarke', 'Initials': 'GC', 'LastName': 'Hillyer', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Moseley', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Arnold', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP/Cancer Center of Kansas - Wichita, Wichita, KS.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Esparaz', 'Affiliation': 'Heartland NCORP/Cancer Care Specialist of Central Illinois, Decatur, IL.'}, {'ForeName': 'Ming C', 'Initials': 'MC', 'LastName': 'Kuan', 'Affiliation': 'Kaiser Permanente NCORP/Kaiser Permanente NCAL, San Leandro, CA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Southeast COR NCORP/Waverly Hematology/Oncology, Cary, NC.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Lackowski', 'Affiliation': 'Northwest NCORP/Central Interstate Medical Office Department Hematology/Oncology, Portland, OR.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Edenfield', 'Affiliation': 'NCORP of the Carolinas (Greenville Health System), Greenville, SC.'}, {'ForeName': 'Zoneddy R', 'Initials': 'ZR', 'LastName': 'Dayao', 'Affiliation': 'New Mexico Minority Underserved NCORP/University of New Mexico Cancer Center, Albuquerque, NM.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Seattle Cancer Care Alliance/University of Washington, Seattle, WA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Ramsey', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Alfred I', 'Initials': 'AI', 'LastName': 'Neugut', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02699'] 91,32371539,Concurrent Definitive Immunoradiotherapy for Patients with Stage III-IV Head and Neck Cancer and Cisplatin Contraindication.,"PURPOSE Although cisplatin plus radiotherapy is a standard treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC), cisplatin contraindication is common. Radiation elicits and promotes tumor-directed immune stimulation, which may potentiate anti-PD-1 therapy. We provide the first efficacy report of combined pembrolizumab and definitive radiotherapy in LA-HNSCC. PATIENTS AND METHODS This single-arm, multi-institution, phase II study (NCT02609503) enrolled 29 cisplatin-ineligible patients. Patients received radiotherapy concurrently with three cycles of pembrolizumab 200 mg every 3 weeks followed by three adjuvant cycles. The primary endpoint was a progression-free survival (PFS) of ≥16 months. Correlative studies included peripheral blood flow cytometry and Luminex cytokine profiling. RESULTS Reasons for cisplatin ineligibility included otopathy (69.0%), nephropathy (20.7%), and neuropathy (6.9%). With median follow-up of 21 months, estimated 24-month PFS and overall survival rates were 71% (95% confidence interval, 49%-84%) and 75% (51%-88%). The primary PFS endpoint has exceeded the hypothesis and its median has not been reached. Toxicities were typical of radiotherapy; however, high rates of grade 3/4 lymphopenia (58.6%) were observed. Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells. Upon treatment, frequencies of transitional B cells and tissue-like memory B cells increased, while resting memory B cells decreased. Patients with progression had greater percentages of baseline naïve B cells and fewer marginal zone B cells. CONCLUSIONS Pembrolizumab and radiotherapy is efficacious in LA-HNSCC and should be evaluated in a randomized trial. The observed changes in B-cell markers deserve further study both as potential biomarkers and as therapeutic targets.",2020,"Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells.","['patients with Stage III-IV Head and Neck Cancer and Cisplatin contraindication', '29 cisplatin ineligible patients', 'locally advanced head and neck squamous cell carcinoma (LA-HNSCC']","['radiotherapy', 'cisplatin plus radiotherapy', 'Concurrent definitive immunoradiotherapy', 'Pembrolizumab and radiotherapy', 'combined pembrolizumab and definitive radiotherapy', 'pembrolizumab']","['rates of grade 3/4 lymphopenia', 'nephropathy', 'OS rates', 'frequencies of transitional B cells and tissue-like memory B cells', 'peripheral blood flow cytometry and Luminex cytokine profiling', 'PFS of >16 months', 'baseline naïve B cells and fewer marginal zone B cells', 'CD4 T cells and B cells, but not CD8 T cells', 'Toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0085101', 'cui_str': 'Radioimmunotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1512631', 'cui_str': 'Immature B-Lymphocytes'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",29.0,0.0669333,"Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells.","[{'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina. eiss@med.unc.edu.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sheth', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Allision M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Department of Biostatistics, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Juneko E', 'Initials': 'JE', 'LastName': 'Grilley Olson', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Samip', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Hackman', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Blumberg', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Galloway', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shetal', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Zanation', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Colette J', 'Initials': 'CJ', 'LastName': 'Shen', 'Affiliation': 'Department of Radiation Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'D Neil', 'Initials': 'DN', 'LastName': 'Hayes', 'Affiliation': 'Division of Hematology and Oncology, University of Tennessee West Institute for Cancer Research, Memphis, Tennessee.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hilliard', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Division of Hematology and Oncology, Marlene and Stewart Greenebaum Comprehensive Cancer Center at the University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'McKinnon', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Hsing-Hui', 'Initials': 'HH', 'LastName': 'Wang', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Mark Christian', 'Initials': 'MC', 'LastName': 'Weissler', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Bauman', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Bhishamjit S', 'Initials': 'BS', 'LastName': 'Chera', 'Affiliation': 'Department of Radiation Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Vincent', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0230'] 92,32377180,Different Degree Centrality Changes in the Brain after Acupuncture on Contralateral or Ipsilateral Acupoint in Patients with Chronic Shoulder Pain: A Resting-State fMRI Study.,"Chronic shoulder pain (CSP) is the third most common musculoskeletal problem. For maximum treatment effectiveness, most acupuncturists usually choose acupoint in the nonpainful side, to alleviate pain or improve shoulder function. This method is named opposite needling, which means acupuncture points on the right side are selected for diseases on the left side and vice versa. However, the underlying neural mechanisms related to treatment are currently unclear. The purpose of this study was to determine whether different mechanisms were observed with contralateral and ipsilateral acupuncture at Tiaokou (ST 38) in patients with unilateral CSP. Twenty-four patients were randomized to the contralateral acupuncture group (contra-group) and the ipsilateral acupuncture group (ipsi-group). The patients received one acupuncture treatment session at ST 38 on the nonpainful or painful sides, respectively. Before and after acupuncture treatment, they underwent functional magnetic resonance scanning. The treatment-related changes in degree centrality (DC) maps were compared between the two groups. We found alleviated pain and improved shoulder function in both groups, but better shoulder functional improvement was observed in the contra-group. Increased DC in the anterior/paracingulate cortex and decreased DC in bilateral postcentral gyri were found in the contra-group, while decreased DC in the bilateral cerebellum and right thalamus was observed in the ipsi-group. Furthermore, the DC value in the bilateral anterior/paracingulate cortex was positively correlated with the treatment-related change in the Constant-Murley score. The current study reveals different changes of DC patterns after acupuncture at contralateral or ipsilateral ST 38 in patients with CSP. Our findings support the hypothesis of acupoint specificity and provide the evidence for acupuncturists to select acupoints for CSP.",2020,"Increased DC in the anterior/paracingulate cortex and decreased DC in bilateral postcentral gyri were found in the contra-group, while decreased DC in the bilateral cerebellum and right thalamus was observed in the ipsi-group.","['patients with unilateral CSP', 'Patients with Chronic Shoulder Pain', 'patients with CSP']","['contralateral and ipsilateral acupuncture at Tiaokou (ST 38', 'Acupuncture', 'contralateral acupuncture group (contra-group) and the ipsilateral acupuncture', 'functional magnetic resonance scanning', 'acupuncture treatment session']","['Chronic shoulder pain (CSP', 'DC patterns', 'alleviated pain and improved shoulder function', 'DC in bilateral postcentral gyri', 'shoulder functional improvement', 'bilateral cerebellum and right thalamus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152302', 'cui_str': 'Structure of postcentral gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}]",24.0,0.0390955,"Increased DC in the anterior/paracingulate cortex and decreased DC in bilateral postcentral gyri were found in the contra-group, while decreased DC in the bilateral cerebellum and right thalamus was observed in the ipsi-group.","[{'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Yan', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Huo', 'Affiliation': 'Department of Radiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Life Sciences, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China.'}, {'ForeName': 'Jin-Ling', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Mirim', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Jia-Kai', 'Initials': 'JK', 'LastName': 'Shao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Shang-Qing', 'Initials': 'SQ', 'LastName': 'Hu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, 11 Beisanhuan East Road, Chaoyang District, Beijing 100029, China.'}]",Neural plasticity,['10.1155/2020/5701042'] 93,32376732,"Oral nitrate supplementation to enhance pulmonary rehabilitation in COPD: ON-EPIC a multicentre, double-blind, placebo-controlled, randomised parallel group study.","RATIONALE Dietary nitrate supplementation has been proposed as a strategy to improve exercise performance, both in healthy individuals and in people with COPD. We aimed to assess whether it could enhance the effect of pulmonary rehabilitation (PR) in COPD. METHODS This double-blind, placebo-controlled, parallel group, randomised controlled study performed at four UK centres, enrolled adults with Global Initiative for Chronic Obstructive Lung Disease grade II-IV COPD and Medical Research Council dyspnoea score 3-5 or functional limitation to undertake a twice weekly 8-week PR programme. They were randomly assigned (1:1) to either 140 mL of nitrate-rich beetroot juice (BRJ) (12.9 mmol nitrate), or placebo nitrate-deplete BRJ, consumed 3 hours prior to undertaking each PR session. Allocation used computer-generated block randomisation. MEASUREMENTS The primary outcome was change in incremental shuttle walk test (ISWT) distance. Secondary outcomes included quality of life, physical activity level, endothelial function via flow-mediated dilatation, fat-free mass index and blood pressure parameters. RESULTS 165 participants were recruited, 78 randomised to nitrate-rich BRJ and 87 randomised to placebo. Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027. Active treatment also impacted on systolic blood pressure: treatment group -5.0 mm Hg (-5.0, -3.0) versus control +6.0 mm Hg (-1.0, 15.5), estimated treatment effect -7 mm Hg (95% CI 7 to -20) (p<0.0005). No significant serious adverse events or side effects were reported. CONCLUSIONS Dietary nitrate supplementation appears to be a well-tolerated and effective strategy to augment the benefits of PR in COPD. TRIAL REGISTRATION NUMBER ISRCTN27860457.",2020,"Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027.","['healthy individuals and in people with COPD', '165 participants were recruited, 78 randomised to', 'COPD', 'four UK centres, enrolled adults with Global Initiative for Chronic Obstructive Lung Disease grade II-IV COPD and Medical Research Council dyspnoea score 3-5 or functional limitation to undertake a twice weekly 8-week PR programme']","['placebo', 'nitrate-rich BRJ', 'Oral nitrate supplementation', '140\u2009mL of nitrate-rich beetroot juice (BRJ) (12.9\u2009mmol nitrate), or placebo nitrate-deplete BRJ', 'pulmonary rehabilitation (PR']","['serious adverse events or side effects', 'Exercise capacity', 'quality of life, physical activity level, endothelial function via flow-mediated dilatation, fat-free mass index and blood pressure parameters', 'systolic blood pressure', 'incremental shuttle walk test (ISWT) distance', 'median (IQR) change in ISWT distance', 'exercise performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",165.0,0.764259,"Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Pavitt', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Rebecca Jayne', 'Initials': 'RJ', 'LastName': 'Tanner', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Buttery', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Bhavin', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jefford', 'Affiliation': 'Greenwich Adult Community Health Service, Oxleas NHS Foundation Trust, Dartford, Kent, UK.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Curtis', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Winston A S', 'Initials': 'WAS', 'LastName': 'Banya', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Husain', 'Affiliation': 'Respiratory Medicine, Maidstone and Tunbridge Wells NHS Trust, Maidstone, Kent, UK.'}, {'ForeName': 'Karnan', 'Initials': 'K', 'LastName': 'Satkunam', 'Affiliation': 'Greenwich Adult Community Health Service, Oxleas NHS Foundation Trust, Dartford, Kent, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Shrikrishna', 'Affiliation': 'Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, Somerset, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Man', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Polkey', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK n.hopkinson@ic.ac.uk.'}]",Thorax,['10.1136/thoraxjnl-2019-214278'] 94,32380445,Intermittent theta-burst stimulation moderates interaction between increment of N-Acetyl-Aspartate in anterior cingulate and improvement of unipolar depression.,"BACKGROUND Intermittent theta-burst stimulation (iTBS), a novel repetitive transcranial magnetic stimulation (rTMS) technique, appears to have antidepressant effects when applied over left dorsolateral prefrontal cortex (DLPFC). However, its underlying neurobiological mechanisms are unclear. Proton magnetic resonance spectroscopy ( 1 H-MRS) provides in vivo measurements of cerebral metabolites altered in major depressive disorder (MDD) like N-acetyl-aspartate (NAA) and choline-containing compounds (Cho). We used MRS to analyse effects of iTBS on the associations between the shifts in the NAA and Cho levels during therapy and MDD improvement. METHODS In-patients with unipolar MDD (N = 57), in addition to treatment as usual, were randomized to receive 20 iTBS or sham stimulations applied over left DLPFC over four weeks. Single-voxel 1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up. Increments of concentrations, as well as MDD improvement, were defined as endpoints. We tested a moderated mediation model of effects using the PROCESS macro (an observed variable ordinary least squares and logistic regression path analysis modeling tool) for SPSS. RESULTS Improvement of depressive symptoms was significantly associated with decrease of Cho/NAA ratio, mediated by NAA. iTBS had a significant moderating effect enhancing the relationship between NAA change and depression improvement. CONCLUSIONS Our findings suggest a potential neurochemical pathway and mechanisms of antidepressant action of iTBS, which may moderate the improvement of metabolic markers of neuronal viability. iTBS might increase neuroplasticity, thus facilitating normalization of neuronal circuit function.",2020,Single-voxel 1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,[],"['Intermittent theta-burst stimulation (iTBS', '20 iTBS or sham stimulations applied over left DLPFC', 'repetitive transcranial magnetic stimulation (rTMS) technique', 'Proton magnetic resonance spectroscopy ( 1 H-MRS']","['Cho/NAA ratio', 'NAA change and depression improvement', 'depressive symptoms', 'unipolar depression']",[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.0453926,Single-voxel 1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,"[{'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Zavorotnyy', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Department of Psychiatry and Psychotherapy, Psychiatric Services Aargau, Academic Hospital of the University of Zurich, Brugg, Switzerland; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany. Electronic address: maxim.zavorotnyy@staff.uni-marburg.de.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zöllner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Health Protection Authority, Frankfurt, Main, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Rekate', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dietsche', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bopp', 'Affiliation': 'Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany; Department of Neurosurgery, University of Marburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Meller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Krug', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nenadić', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.03.015'] 95,32380449,Effects of high-frequency repetitive transcranial magnetic stimulation over the contralesional motor cortex on motor recovery in severe hemiplegic stroke: A randomized clinical trial.,"BACKGROUND The contralesional hemisphere compensation may play a critical role in the recovery of stroke when there is extensive damage to one hemisphere. There is little research on the treatment of hemiplegia by high-frequency repetitive transcranial magnetic stimulation (rTMS) delivered to the contralesional cortex. OBJECTIVE We conducted a 2-week randomized, sham-controlled, single-blind trial to determine whether high-frequency rTMS (HF-rTMS) over the contralesional motor cortex can improve motor function in severe stroke patients. METHODS Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory were randomly assigned to treatment with 10 Hz rTMS (HF group), 1 Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks. The primary outcome was the change in the Fugl-Meyer Motor Assessment (FMA) Scale score from baseline to 2 weeks. The secondary endpoints included root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability. RESULTS The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group. There were no significant differences between the LF group and sham group. There was a positive correlation between cortical conductivity of the uninjured hemisphere and recovery of motor impairment (p = 0.039). CONCLUSIONS HF-rTMS over the contralesional cortex was superior to low-frequency rTMS and sham stimulation in promoting motor recovery in patients with severe hemiplegic stroke by acting on contralesional cortex plasticity. TRIAL REGISTRATION Clinical trial registered with the Chinese Clinical Trial Registry at http://www.chictr.org.cn/showproj.aspx?proj=23264 (ChiCTR-IPR-17013580).",2020,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","['severe hemiplegic stroke', 'Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory', 'patients with severe hemiplegic stroke', 'severe stroke patients']","['high-frequency repetitive transcranial magnetic stimulation', 'HF-rTMS', 'high-frequency rTMS (HF-rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\xa0Hz rTMS (HF group), 1\xa0Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks']","['FMA score', 'root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability', 'change in the Fugl-Meyer Motor Assessment (FMA) Scale score', 'cortical conductivity of the uninjured hemisphere and recovery of motor impairment', 'contralesional hemisphere cortical excitability and conductivity', 'RMS-SEMG of the key muscles']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",45.0,0.537609,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ying-Yu', 'Initials': 'YY', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Hai', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yue-Wen', 'Initials': 'YW', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China. Electronic address: mayw@cmu1h.com.'}]",Brain stimulation,['10.1016/j.brs.2020.03.020'] 96,32384056,Young People's Experience of a Long-Term Social Media-Based Intervention for First-Episode Psychosis: Qualitative Analysis.,"BACKGROUND Digital mental health interventions present a unique opportunity to address the lack of social connection and loneliness experienced by young people with first-episode psychosis (FEP). The first generation of digital interventions, however, is associated with high attrition rates. Social media presents an opportunity to target this issue. A new generation of digital intervention has harnessed the popularity of social media to both promote engagement and foster social connectedness in youth mental health interventions. Despite their potential, little is known about how young people engage with, and experience, social media-based interventions as well as the optimal design, implementation, and management needed to ensure young people with psychosis receive benefit. OBJECTIVE This study aimed to explore how young people engage with, and experience, a long-term social media-based mental health intervention designed to address social functioning in individuals with FEP. METHODS This qualitative study was based on 12 interviews with young people who used Horyzons, a long-term social media-based mental health intervention, as part of a previous randomized controlled trial. A semistructured phenomenological interview guide with open-ended questions was used to explore young people's subjective experience of the intervention. All interviews were recorded and transcribed verbatim. Data were analyzed using interpretative phenomenological analysis. RESULTS A total of 4 superordinate themes emerged during the analysis including (1) shared experience as the catalyst for a cocreated social space, (2) the power of peer support, (3) an upbeat environment, and (4) experiences that interrupt being in Horyzons. CONCLUSIONS We found that Horyzon's therapeutic social network fostered a connection and an understanding among young people. It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term. However, although we found that most young people had strong positive experiences of a social connection on Horyzons, we also found that they experienced significant barriers that could substantively interrupt their ability to use the platform. We found that social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion interfered with young people's usage of the platform. From a design perspective, digital interventions are flexible and thus equipped to begin addressing these implications by providing customizable and personalized treatment options that account for varying levels of social connection and psychological need that could otherwise interrupt young people's usage of social media-based interventions.",2020,It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term.,"['young people', 'young people engage with, and experience, a long-term social media-based mental health intervention designed to address social functioning in individuals with', 'young people with first-episode psychosis (FEP', '12 interviews with young people who used Horyzons, a long-term social media-based mental health intervention, as part of a previous randomized controlled trial']",['digital intervention'],"['social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]",12.0,0.0185373,It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term.,"[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Valentine', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'McEnery', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Shaunagh', 'Initials': 'S', 'LastName': ""O'Sullivan"", 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, Parkville, Australia.'}]",Journal of medical Internet research,['10.2196/17570'] 97,32385554,Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients.,"INTRODUCTION Home chlorhexidine washes prior to shoulder surgery are commonly used in an attempt to reduce the skin bacterial load. However, recent studies have suggested that this agent is relatively ineffective against Cutibacterium acne. Benzoyl peroxide soap is a treatment for acne, but evidence regarding its effectiveness as prophylaxis in shoulder surgery is lacking. Therefore, the objective of this study was to compare the effectiveness of home chlorhexidine washes with benzoyl peroxide soap (BPO) in patients undergoing shoulder arthroplasty surgery in reducing Cutibacterium levels on the skin surface and in the dermis. METHODS Fifty male patients planning to undergo shoulder arthroplasty were consented to be randomized into treatment with 4% chlorhexidine solution (CHG) and 10% benzoyl peroxide soap (BPO) used to wash the operative shoulder the night prior and morning of surgery. Skin swabs prior to incision and dermal wound swabs after incision were obtained, and the bacterial load was reported in a semiquantitative manner as the Specimen Cutibacterium Value (SpCuV). The two groups were compared with regards to the percent positivity of the skin surface and incised dermal edge as well as the bacterial load at each site. RESULTS Skin surface swabs were positive in 100% of patients using CHG and 100% of patients using BPO soap. The Cutibacterium load (SpCuV) on the skin surface was similar between the two groups (CHG 1.6 ± 1.1 vs. BPO 1.5 ± 1.4, p = 0.681). The percentages of dermal cultures that were positive were not significantly different between the two groups (CHG 61% vs BPO 46%, p = 0.369). The Cutibacterium load (SpCuV) on the incised dermal edge was similar between the two groups (CHG 0.8 ± 1.0 vs. BPO 0.8 ± 1.4, p = 0.991). DISCUSSION Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge. Further study of means of reducing the Cutibacterium load of the skin at the time of shoulder arthroplasty is warranted.",2020,Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge.,"['Fifty male patients planning to undergo shoulder arthroplasty', 'patients undergoing shoulder arthroplasty surgery in reducing Cutibacterium levels on the skin surface and in the dermis', 'shoulder arthroplasty patients']","['benzoyl peroxide soap', 'chlorhexidine washes with benzoyl peroxide soap (BPO', 'chlorhexidine', 'Benzoyl peroxide soap', 'chlorhexidine solution (CHG) and 10% benzoyl peroxide soap (BPO) used to wash the operative shoulder the night prior and morning of surgery']","['Cutibacterium load (SpCuV) on the incised dermal edge', 'Cutibacterium load (SpCuV) on the skin surface', 'percentages of dermal cultures']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4433919', 'cui_str': 'Cutibacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C4433919', 'cui_str': 'Cutibacterium'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",50.0,0.0230374,Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge.,"[{'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Anastasia J', 'Initials': 'AJ', 'LastName': 'Whitson', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Woodhead', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Napierala', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Davin', 'Initials': 'D', 'LastName': 'Gong', 'Affiliation': 'University of Washington School of Medicine, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Frederick A', 'Initials': 'FA', 'LastName': 'Matsen', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA. matsen@uw.edu.'}]",International orthopaedics,['10.1007/s00264-020-04594-x'] 98,32385598,Effect of real-time virtual reality-based teaching cues on learning needle passing for robot-assisted minimally invasive surgery: a randomized controlled trial.,"PURPOSE Current virtual reality-based (VR) simulators for robot-assisted minimally invasive surgery (RAMIS) training lack effective teaching and coaching. Our objective was to develop an automated teaching framework for VR training in RAMIS. Second, we wanted to study the effect of such real-time teaching cues on surgical technical skill acquisition. Third, we wanted to assess skill in terms of surgical technique in addition to traditional time and motion efficiency metrics. METHODS We implemented six teaching cues within a needle passing task on the da Vinci Skills Simulator platform (noncommercial research version). These teaching cues are graphical overlays designed to demonstrate ideal surgical technique, e.g., what path to follow while passing needle through tissue. We created three coaching modes: TEACH (continuous demonstration), METRICS (demonstration triggered by performance metrics), and USER (demonstration upon user request). We conducted a randomized controlled trial where the experimental group practiced using automated teaching and the control group practiced in a self-learning manner without automated teaching. RESULTS We analyzed data from 30 participants (14 in experimental and 16 in control group). After three practice repetitions, control group showed higher improvement in time and motion efficiency, while experimental group showed higher improvement in surgical technique compared to their baseline measurements. The experimental group showed more improvement than the control group on a surgical technique metric (at what angle is needle grasped by an instrument), and the difference between groups was statistically significant. CONCLUSION In a pilot randomized controlled trial, we observed that automated teaching cues can improve the performance of surgical technique in a VR simulator for RAMIS needle passing. Our study was limited by its recruitment of nonsurgeons and evaluation of a single configuration of coaching modes.",2020,"The experimental group showed more improvement than the control group on a surgical technique metric (at what angle is needle grasped by an instrument), and the difference between groups was statistically significant. ","['30 participants (14 in experimental and 16 in control group', 'robot-assisted minimally invasive surgery']","['automated teaching cues', 'automated teaching and the control group practiced in a self-learning manner without automated teaching', 'real-time virtual reality-based teaching cues', 'virtual reality-based (VR) simulators for robot-assisted minimally invasive surgery (RAMIS) training']","['surgical technical skill acquisition', 'surgical technique metric', 'surgical technique', 'time and motion efficiency']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",30.0,0.0306309,"The experimental group showed more improvement than the control group on a surgical technique metric (at what angle is needle grasped by an instrument), and the difference between groups was statistically significant. ","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Malpani', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA. anandmalpani@jhu.edu.'}, {'ForeName': 'S Swaroop', 'Initials': 'SS', 'LastName': 'Vedula', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Intuitive Surgical Inc., 1020 Kifer Road, Sunnyvale, CA, 94086, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Hager', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA.'}, {'ForeName': 'Russell H', 'Initials': 'RH', 'LastName': 'Taylor', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA.'}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-020-02156-5'] 99,32390309,"A retrospective assessment and comparison of the effectiveness of benzoyl peroxide; the combination of topical niacinamide, gallic acid, and lauric acid; and the combination of benzoyl peroxide and erythromycin in acne vulgaris.","Acne vulgaris is a chronic inflammatory skin disease that mostly develops during adolescence and continues throughout adulthood. It affects the face, the main location of cosmetic appearance. Despite many developments in acne treatment, various combination therapies are needed to create the best option. Ninety patients were included in this study. We used the global acne grading system (GAGS) and the lesion counting and photographic standards that were used by Hayashi et al., to assess acne severity. The patients were randomly divided into three groups as group 1 (using only 5% BPO, twice a day), group 2 (using only the combination of 5% BPO + 3% erythromycin, twice a day), and group 3 (using only the combination of 4% niacinamide + 1% gallic acid + 1% lauric acid, twice a day). Thirty patients were included in each group. The scores were evaluated at weeks 0, 2, 4 and 8, and compared with each other. As a result of the study, all three treatment types were found to be effective. The combination of 4% niacinamide + 1% gallic acid + 1% lauric acid can be used as an alternative topical treatment for acne vulgaris to prevent resistance against topical antibiotics and the side effects of some other treatments.",2020,"As a result of the study, all three treatment types were found to be effective.","['30 patients were included in each group', 'Ninety patients were included in this study', 'acne vulgaris']","['benzoyl peroxide', 'BPO\u2009+\u20093% erythromycin, twice a day) and Group 3 (using only the combination of 4% niacinamide +1% gallic acid +1% lauric acid', 'niacinamide +1% gallic acid +1% lauric acid', 'topical niacinamide, gallic acid and lauric acid and the combination of benzoyl peroxide and erythromycin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]",[],90.0,0.0201762,"As a result of the study, all three treatment types were found to be effective.","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kozan', 'Affiliation': 'Amasya University Sabuncuoglu Serefeddin Training and Research Hospital-Dermatology, Amasya, Turkey.'}, {'ForeName': 'Rukiye Yasak', 'Initials': 'RY', 'LastName': 'Guner', 'Affiliation': 'Dermatology Department, Cumhuriyet University School of Medicine, Sivas, Turkey.'}, {'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Dermatology Department, Cumhuriyet University School of Medicine, Sivas, Turkey.'}]",Dermatologic therapy,['10.1111/dth.13534'] 100,32387453,"Clinical and molecular characteristics and treatment outcomes of advanced right-colon, left-colon and rectal cancers: data from 1180 patients in a phase III trial of panitumumab with an extended biomarker panel.","BACKGROUND Primary tumour location (PTL) is being adopted by clinicians to guide treatment decisions in metastatic colorectal cancer (mCRC). Here we test PTL as a predictive marker for panitumumab efficacy, and examine its relationship with an extended biomarker profile. We also examine rectal tumours as a separate location. PATIENTS AND METHODS mCRC patients from the second-line PICCOLO trial of irinotecan versus irinotecan/panitumumab (IrPan). PTL was classified as right-PTL, left-PTL or rectal-PTL. PTL was assessed as a predictive biomarker for IrPan effect in RAS-wild-type (RAS-wt) patients (compared with irinotecan alone), then tested for independence alongside an extended biomarker profile (BRAF, epiregulin/amphiregulin (EREG/AREG) and HER3 mRNA expression). RESULTS PTL data were available for 1180 patients (98.5%), of whom 558 were RAS-wt. High HER3 expression was independently predictive of panitumumab overall survival improvement, but PTL and EREG/AREG were not. IrPan progression-free survival (PFS) improvement compared with irinotecan was seen in left-PTL [hazard ratio (HR) = 0.61, P = 0.002) but not right-PTL (HR = 0.98, P = 0.90) (interaction P = 0.05; RAS/BRAF-wt interaction P = 0.10), or in rectal-PTL (HR = 0.82, P = 0.20) (interaction P = 0.14 compared with left-PTL; RAS/BRAF-wt interaction P = 0.04). Patients with right-PTL and high EREG/AREG or HER3 expression, had IrPan PFS improvement (high EREG/AREG HR = 0.20, P = 0.04; high HER3 HR = 0.33, P = 0.10) compared with irinotecan. Similar effect was seen for rectal-PTL patients (high EREG/AREG HR = 0.44, P = 0.03; high HER3 HR = 0.34, P = 0.05). CONCLUSIONS RAS-wt patients with left-PTL are more likely to have panitumumab PFS advantage than those with right-PTL or rectal-PTL. However, an extended biomarker panel demonstrated significant heterogeneity in panitumumab PFS effect within a tumour location. AREG/EREG and HER3 mRNA expression identifies patients with right-PTL or rectal-PTL who achieve similar PFS effect with panitumumab as left-colon patients. Testing could provide a more reliable basis for clinical decision making. Further validation and development of these biomarkers is required to optimise routine patient care. CLINICAL TRIAL REGISTRATION ISRCTN identifier: ISRCTN93248876.",2020,"IrPan PFS improvement compared with irinotecan was seen in left-PTL (HR=0.61,p=0.002) but not right-PTL (HR=0.98,p=0.90)(interaction p=0.05; RAS/BRAF-wt interaction p=0.10), or in rectal-PTL (HR=0.82,p=0.20)(interaction p=0.14 compared with left-PTL; RAS/BRAF-wt interaction p=0.04).","['advanced colorectal cancer (aCRC', 'advanced right-colon, left-colon and rectal cancers', '1180 patients in a phase III trial of panitumumab with an extended biomarker panel', 'aCRC patients from the second-line PICCOLO trial of']","['irinotecan /panitumumab', 'irinotecan versus irinotecan/panitumumab', 'panitumumab', 'irinotecan']","['IrPan PFS improvement', 'High HER3 expression', 'EREG/AREG or HER3 expression, had IrPan PFS improvement']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0072460', 'cui_str': 'Proto-Oncogene Protein erbB-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C3884279', 'cui_str': 'EREG protein, human'}, {'cui': 'C3884535', 'cui_str': 'AREG protein, human'}]",558.0,0.0774107,"IrPan PFS improvement compared with irinotecan was seen in left-PTL (HR=0.61,p=0.002) but not right-PTL (HR=0.98,p=0.90)(interaction p=0.05; RAS/BRAF-wt interaction p=0.10), or in rectal-PTL (HR=0.82,p=0.20)(interaction p=0.14 compared with left-PTL; RAS/BRAF-wt interaction p=0.04).","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Seligmann', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK. Electronic address: j.seligmann@leeds.ac.uk.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Elliott', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Richman', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hemmings', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jacobs', 'Affiliation': 'Molecular Digestive Oncology Unit, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Molecular Digestive Oncology Unit, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Barrett', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Seymour', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.476'] 101,32389383,Influence of an Audiovisual Resource on the Preoperative Anxiety of Adult Endodontic Patients: A Randomized Controlled Clinical Trial.,"INTRODUCTION The expectation of undergoing endodontic treatment can cause anxiety in patients. Anxiety is described as a transient emotional state closely related to pain, fear, and imbalance of the organism. The clinician commonly must use some type of tool to alleviate the patient's preoperative anxiety before treatment can be applied. The aim of this study was to evaluate the influence of an audiovisual resource on the preoperative anxiety of adult patients undergoing endodontic treatment. METHODS One hundred sixty endodontic patients were randomly divided into experimental and control groups (n = 80) and then assessed at 2 preoperative time points separated by a 10-minute interval. After the first assessment, the patients in the experimental group watched a video of their own choice obtained from the Internet to provide them with a relaxing experience. In both groups and at both time points, the assessments consisted of collecting the patients' vital signs (diastolic blood pressure, systolic blood pressure, and heart rate) and data regarding their subjective perception of anxiety using a visual analog scale. RESULTS There were no significant differences between the groups regarding the vital sign variation observed between the 2 assessment time points. However, the variation in the scores obtained on the visual analog scale was significantly greater in the experimental group (P < .05), indicating a greater reduction in the level of preoperative anxiety in this group. CONCLUSIONS The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.",2020,The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.,"['patients undergoing endodontic treatment', 'adult patients undergoing endodontic treatment', 'Adult Endodontic Patients', 'patients', 'One hundred sixty endodontic patients']","['audiovisual resource', 'Audiovisual Resource']","['level of preoperative anxiety', 'visual analog scale', 'vital sign variation', 'vital signs (diastolic blood pressure, systolic blood pressure, and heart rate) and data regarding their subjective perception of anxiety using a visual analog scale', 'perception of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",160.0,0.0247464,The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.,"[{'ForeName': 'Marco André', 'Initials': 'MA', 'LastName': 'Craveiro', 'Affiliation': 'Discipline of Endodontics, Department of Restorative Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: andre.craveiro@usp.br.'}, {'ForeName': 'Celso Luiz', 'Initials': 'CL', 'LastName': 'Caldeira', 'Affiliation': 'Discipline of Endodontics, Department of Restorative Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.03.024'] 102,32394049,A Large-Scale Replication of the Effectiveness of the KiVa Antibullying Program: a Randomized Controlled Trial in the Netherlands.,"This study evaluates the effectiveness of the KiVa antibullying program in the Netherlands through a randomized controlled trial of students in grades 3-4 (Dutch grades 5-6). The sample involved 98 schools who volunteered to participate in the research, with 245 classes and 4383 students at the baseline (49% girls; M age = 8.7 years), who participated in five measurement waves, collected in three consecutive school years. After the baseline, two-thirds of the schools were assigned to the intervention condition (KiVa or KiVa+, the latter included an additional intervention component of network feedback to teachers) and one-third to the control condition (waiting list, care as usual) with a stratified randomization procedure. The effects of the intervention on self-reported victimization and bullying were tested using cross-classified ordered multinomial models and binomial logistic regression models. These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation. The results showed that for students in control schools, the odds of being a victim were 1.29-1.63 higher, and the odds of being a bully were 1.19-1.66 higher than for KiVa students. No significant differences between KiVa and KiVa+ emerged. Overall, the findings provide evidence of the effectiveness of the KiVa program in the Netherlands.",2020,"These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation.","['students in grades 3-4 (Dutch grades 5-6', '98 schools who volunteered to participate in the research, with 245 classes and 4383 students at the baseline (49% girls; M age\u2009=\u20098.7\xa0years), who participated in five measurement waves, collected in three consecutive school years']","['KiVa Antibullying Program', 'intervention condition (KiVa or KiVa+, the latter included an additional intervention component of network feedback to teachers) and one-third to the control condition (waiting list, care as usual) with a stratified randomization procedure', 'KiVa antibullying program']",['odds of being a victim'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1278569', 'cui_str': 'WAS A'}]",98.0,0.0250472,"These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation.","[{'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Huitsing', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands. g.e.huitsing@rug.nl.'}, {'ForeName': 'Gerine M A', 'Initials': 'GMA', 'LastName': 'Lodder', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}, {'ForeName': 'Wiliam J', 'Initials': 'WJ', 'LastName': 'Browne', 'Affiliation': 'School of Education, University of Bristol, Bristol, UK.'}, {'ForeName': 'Beau', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Van der Ploeg', 'Affiliation': 'Department of Pedagogy and Educational Science, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Veenstra', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01116-4'] 103,32394733,"Perceived Stress, Subjective, and Objective Symptoms of Disturbed Sleep in Men and Women with Stable Heart Failure.","Objective/Background : Sleep disturbance is prevalent among patients with heart failure (HF) and is associated with increased morbidity and mortality. Stress also affects health and quality of life among patients with cardiovascular disease and likely plays a prominent role in HF. However, little is known about the associations between stress and sleep among HF patients. Participants : One hundred fifty-three stable New York Heart Association (NYHA) Classification I-IV HF patients with at least low symptoms of insomnia (M age :63.0 ± 12.8, 42% Women). Methods: We examined baseline stress, sleep disturbance, and sleep-related characteristics from a randomized controlled trial of cognitive behavioral therapy for insomnia, including the Perceived Stress Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Sleep Disturbance Questionnaire, Dysfunctional Beliefs about Sleep Scale, PROMIS Cognitive Ability, SF-36 Mental Health, and wrist actigraphy. We used Pearson correlations and general linear models to assess stress-sleep associations, including the potential moderating effects of sex and symptom severity (NYHA). Results : There were moderate-to-large correlations between stress and self-reported sleep disturbance, dysfunctional beliefs about sleep, cognitive ability, and mental health ( p 's < 0.01). High stress was associated with more objectively-measured (i.e., actigraph-assessed) awakenings and sleep fragmentation among women than men ( β  = - 0.04, p < 0.01; β  = - 0.71, p = 0.04). Relationships between stress and objectively-measured sleep did not vary by symptom severity. Conclusions : Perceived stress is related to sleep disturbance among HF patients, and effects may be sex-dependent. Subsequent research should determine the temporal links between sleep and stress, and optimal opportunities for intervention among HF patients.",2020,Relationships between stress and objectively-measured sleep did not vary by symptom severity.,"['Participants ', 'patients with cardiovascular disease', 'One hundred fifty-three stable New York Heart Association (NYHA) Classification I-IV HF patients with at least low symptoms of insomnia (M age :63.0\xa0±\xa012.8, 42% Women', 'HF patients', 'patients with heart failure (HF', 'Men and Women with Stable Heart Failure']","[' ', 'cognitive behavioral therapy']","['objectively-measured (i.e., actigraph-assessed) awakenings and sleep fragmentation', 'health and quality of life', 'Perceived Stress Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Sleep Disturbance Questionnaire, Dysfunctional Beliefs about Sleep Scale, PROMIS Cognitive Ability, SF-36 Mental Health, and wrist actigraphy', 'Perceived Stress, Subjective, and Objective Symptoms of Disturbed Sleep', 'Sleep disturbance', 'sleep disturbance, dysfunctional beliefs about sleep, cognitive ability, and mental health', 'morbidity and mortality', 'baseline stress, sleep disturbance, and sleep-related characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0347296,Relationships between stress and objectively-measured sleep did not vary by symptom severity.,"[{'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Gaffey', 'Affiliation': 'Department of Internal Medicine (Cardiovascular Medicine), Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Conley', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine (Cardiovascular Medicine), Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Garrett I', 'Initials': 'GI', 'LastName': 'Ash', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': ""O'Connell"", 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Linsky', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Redeker', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1762601'] 104,32304981,Opioid overdose reversals using naloxone in New York City by people who use opioids: Implications for public health and overdose harm reduction approaches from a qualitative study.,"BACKGROUND Adverse reactions to naloxone, such as withdrawal symptoms and aggression, are widely recognised in the literature by pharmaceutical manufacturers and clinical practitioners as standard reactions of individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose. This paper seeks to provide a differentiated view on reactions to naloxone that may have important implications for public health and harm reduction approaches. METHODS Analyses from a qualitative investigation embedded within a 5-year Randomised Controlled Trial (RCT) examined the risks and benefits of Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training) in various populations of people who use opioids in New York City. The qualitative experiences (obtained through semi-structured interviews) of 46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied. Situational analysis and inductive content analysis of interview data focused upon overdose reversals in an attempt to provide understandings of the various adverse effects associated with naloxone from their perspective. These analyses were supplemented by data sessions within the research team during which the findings obtained from situational analysis and inductive content analysis were reviewed and complemented by deductive (clinical) appraisals of the various physical and psychological effects associated with the overdose reversals. RESULTS People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone. These outcomes are here termed, (i) 'rage' (describing a wide range of angry, hostile and/or aggressive outbursts), (ii) 'withdrawal symptoms,' and (iii) 'not rage, not withdrawal' (i.e., a wide range of short-lived, 'harmless' conditions (such as temporary amnesia, mild emotional outbursts, or physical discomfort) that do not include rage or withdrawal symptoms). CONCLUSION Physical and psychological reactions to naloxone should not be understood exclusively as a consequence of acute, opioid-related, withdrawal symptoms. The three distinct and interconnected reversal outcomes identified in this study are considered from a harm reduction policy perspective and are further framed by concepts associated with 'mediated toxicity' (i.e., harm triggered by medicine). The overall conclusion is that harm reduction training programmes that are aligned to the policy and practice of take home naloxone may be strengthened by including awareness and training in how to best respond to 'rage' associated with overdose reversal following naloxone administration by people who use opioids and other laypersons.",2020,"RESULTS People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","['46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied', 'individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose', 'various populations of people who use opioids in New York City']","['Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training', 'naloxone']",['successful opioid overdose reversal'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",,0.0390371,"RESULTS People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom.""}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London SE5 8AZ, United Kingdom.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102751'] 105,32371199,Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study.,"BACKGROUND Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes. DESIGN The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an implantable cardiac monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed. RESULTS There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P < 0.01 for all categorical comparisons). Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence). CONCLUSIONS Classification of AF pattern based on pre-ablation continuous cardiac rhythm monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation. TRIAL REGISTRATION ClinicalTrials.govNCT01913522.",2020,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence). ",['346 patients enrolled in'],"['implantable cardiac monitor', 'CIRCA-DOSE']","['AF burden, and post-ablation arrhythmia outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",346.0,0.0501133,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence). ","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada; Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada. Electronic address: Jason.andrade@vch.ca.'}, {'ForeName': 'Robert R J', 'Initials': 'RRJ', 'LastName': 'Yao', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rizkallah', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Umjeet', 'Initials': 'U', 'LastName': 'Jolly', 'Affiliation': ""St. Mary's Hospital, Kitchener, Canada.""}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'St. Boniface Hospital, Winnipeg, Canada.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Raymond', 'Affiliation': 'Centre Hospitalier Universitaire de Montreal, Université de Montréal, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steinberg', 'Affiliation': 'Department of Medicine, Université Laval, Quebec, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Toronto General Hospital, University of Toronto, Toront006F, Canada.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Luong', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Glover', 'Affiliation': 'Sunnybrook Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.008'] 106,32379238,Intervention for Reducing Sleep Disturbances After a 12-Time Zone Transition.,"Hoshikawa, M, Uchida, S, and Dohi, M. Intervention for reducing sleep disturbances after a 12-time zone transition. J Strength Cond Res 34(7): 1803-1807, 2020-The purpose of this study was to examine the effect of an intervention consisting of bright light exposure, sleep schedule shifts, and ramelteon on sleep disturbances after a transition of 12 time zones. Two groups, which flew from Tokyo to Rio, participated in this study. The experimental group received the treatment, whereas the control group did not receive any treatment. The experimental group members were exposed to bright light at night and their sleep-wake schedules were gradually delayed for 4 days before their flight. They also took 8 mg of ramelteon once a day for 5 days from the day of their first flight. Both groups departed Tokyo at 14:05, transiting through Frankfurt and arriving in Rio at 05:05. In Rio, it was recommended that they go to bed earlier than usual if they experienced sleepiness. Nocturnal sleep variables measured by wristwatch actigraphy and subjective morning tiredness were compared between groups. Statistical analysis revealed shorter sleep onset latencies (SOLs) in the experimental group (p < 0.01). The SOLs in Rio were 7.7 ± 2.5 minutes for the experimental group and 16.3 ± 3.7 minutes for the control group (d = 0.89, effect size: large). Sleep efficiency for the first 3 nights in Rio was 88.5 ± 1.2% for the experimental group and 82.9 ± 3.0% for the control group (p < 0.01, d = 1.09, effect size: large). These results suggest that the intervention reduced sleep disturbances in Rio. Our intervention may increase the options for conditioning methods for athletic events requiring time zone transitions.",2020,Statistical analysis revealed shorter sleep onset latencies (SOLs) in the experimental group (p < 0.01).,[],"['J Strength Cond Res XX(X', 'control group did not receive any treatment', 'bright light at night and their sleep-wake schedules']","['sleep disturbances', 'Sleep efficiency', 'Sleep Disturbances', 'Nocturnal sleep variables measured by wristwatch actigraphy and subjective morning tiredness', 'sleep onset latencies (SOLs']",[],"[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",,0.0180782,Statistical analysis revealed shorter sleep onset latencies (SOLs) in the experimental group (p < 0.01).,"[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Hoshikawa', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, Tokyo, Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Uchida', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Mitakajima, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Dohi', 'Affiliation': 'Sports Medical Center, Japan Institute of Sports Sciences, Tokyo, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003640'] 107,32388694,Supporting Infant Emotion Regulation Through Attachment-Based Intervention: a Randomized Controlled Trial.,"Infant emotion regulation has long-term implications for human development, highlighting the need for preventive interventions that support emotion regulation early in life. Such interventions may be especially important for infants higher in emotional reactivity who need to regulate their emotions more frequently and intensely than infants lower in emotional reactivity. The current randomized trial examined main and moderated effects of an attachment-based intervention on (a) infants' use of mother-oriented and self-soothing emotion regulation strategies and (b) infant emotion dysregulation in 186 low-income, predominantly Latino infants. We tested the brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention in the context of home-based federal Early Head Start (EHS) services. Control participants received home-based EHS plus 10 weekly books. Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31). Infant emotional reactivity moderated intervention impacts on mother-oriented emotion regulation strategies and on infant emotion dysregulation: We found stronger effects of the intervention for infants relatively higher in emotional reactivity. Findings are discussed in terms of the preventive value of attachment-based interventions for supporting early emotion regulation.",2020,Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31).,"['186 low-income, predominantly Latino infants', 'infants relatively higher in emotional reactivity']","['home-based EHS plus 10 weekly books', 'attachment-based intervention', 'brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention', 'mother-oriented and self-soothing emotion regulation strategies and (b) infant emotion dysregulation']",['infant emotion dysregulation'],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",186.0,0.0256925,Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31).,"[{'ForeName': 'Allison D', 'Initials': 'AD', 'LastName': 'Hepworth', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood St., Baltimore, MD, 21201, USA. allison.hepworth@ssw.umaryland.edu.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Berlin', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood St., Baltimore, MD, 21201, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Martoccio', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Cannon', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Berger', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Brenda Jones', 'Initials': 'BJ', 'LastName': 'Harden', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01127-1'] 108,32289325,Caloric compensation and appetite control in children of different weight status and predisposition to obesity.,"To prevent childhood obesity it is critical to identify behavioral phenotypes for overeating, especially among children who are predisposed to obesity. We examined caloric compensation and appetite control in 212 normal-weight (NW) and obese (OB) children, ages 7 to 9, who were at high risk (HR) or low risk (LR) for obesity based on maternal obesity. In a within-subjects crossover design, children ate breakfast, lunch, dinner, and snacks in the laboratory once a week for two weeks. Children's percentage compensation index (%COMPX) was computed at breakfast. Twenty-five minutes before breakfast, children received one of two compulsory preloads, which varied in energy density (ED) and caloric content [Low ED (LED): 1.00 kcal/g; 100 kcal; High ED (HED): 1.60 kcal/g; 160 kcal]. Children's appetite was measured hourly using Visual Analog Scales, which were used to compute 3-h post-prandial area under the curve (AUCs) after breakfast and the satiety quotient (SQ), which allows between-group comparisons of a fixed amount of a food's potency to reduce appetite sensations per unit of intake. There were no significant differences in %COMPX, SQ, or AUC among LR-NW, HR-NW, and HR-OB children (P > 0.10). SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009). Further, the SQ and AUC for Desire to Eat and AUC for Prospective Consumption significantly predicted energy intake during the remainder of the day (P < 0.03). In this study, HR-NW children did not differ from LR-NW or HR-OB children in their caloric compensation or appetite control. Foods with a high satiating effect may facilitate appetite control and help to moderate daily energy intake in all children, including at-risk children.",2020,SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009).,"['212 normal-weight (NW) and obese (OB) children, ages 7 to 9, who were at high risk (HR) or low risk (LR) for obesity based on maternal obesity', 'children who are predisposed to obesity', 'children of different weight status and predisposition to obesity']","['caloric content [Low ED (LED): 1.00\u202fkcal/g; 100\u202fkcal; High ED (HED', 'Caloric compensation and appetite control']","[""Children's percentage compensation index"", 'COMPX, SQ, or AUC among LR-NW, HR-NW, and HR-OB children', ""Children's appetite"", 'SQs for Hunger and Prospective Consumption', 'energy intake']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0746977', 'cui_str': 'Maternal Obesity'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",212.0,0.0314051,SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009).,"[{'ForeName': 'Tanja V E', 'Initials': 'TVE', 'LastName': 'Kral', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: tkral@nursing.upenn.edu.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Quinn', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA, USA.'}]",Appetite,['10.1016/j.appet.2020.104701'] 109,32289471,Improving health engagement and lifestyle management for breast cancer survivors with diabetes.,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov, NCT02970344, registered 11/22/2016.",2020,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes.","['Many breast cancer survivors with type 2 diabetes', 'breast cancer survivors with type 2 diabetes', 'breast cancer survivors with diabetes', 'breast cancer survivors', 'Breast cancer survivors with type 2 diabetes']","['healthy lifestyle skills training', 'novel diabetes coping skills training (DCST) intervention', 'telephone-based DCST protocol integrates three key theory-based strategies: coping skills training', 'novel behavioral intervention', 'DCST intervention plus diabetes education']","['Symptoms, distress, diabetes self-management behaviors, and self-efficacy', 'Glycosylated hemoglobin (HbA1c']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0336858,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes.","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Shelby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: rebecca.shelby@duke.edu.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Dorfman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Arthur', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America; Division of General Internal Medicine, Duke University, Durham, NC, United States of America; Department of Population Health Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Leonor', 'Initials': 'L', 'LastName': 'Corsino', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Alaattin', 'Initials': 'A', 'LastName': 'Erkanli', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Cheyenne', 'Initials': 'C', 'LastName': 'Corbett', 'Affiliation': 'Supportive Care and Survivorship Center, Duke Cancer Institute, Durham, NC, United States of America.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Kimmick', 'Affiliation': 'Division of Medical Oncology, Duke University Medical Center, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105998'] 110,32179138,Cost-effectiveness of community mobilization (Camino Verde) for dengue prevention in Nicaragua and Mexico: A cluster randomized controlled trial.,"BACKGROUND We assessed the cost-effectiveness of Camino Verde, a community-based mobilization strategy to prevent and control dengue and other mosquito-borne diseases. A cluster-randomized controlled trial in Managua, Nicaragua, and in three coastal regions in Guerrero, Mexico (75 intervention and 75 control clusters), Camino Verde used non-governmental community health workers, called brigadistas, to support community mobilization. This donor-funded trial demonstrated reductions of 29.5% (95% confidence interval, CI: 3.8%-55.3%) on dengue infections and 24.7% (CI: 1.8%-51.2%) on self-reported cases. METHODS We estimated program costs through a micro-costing approach and semi-structured questionnaires. We show results as incremental cost-effectiveness ratios (ICERs) for costs per disability-adjusted life-year (DALYs) averted and conducted probabilistic sensitivity analyses. FINDINGS The Camino Verde trial spent US$16.72 in Mexico and $7.47 in Nicaragua per person annually. We found an average of 910 (CI: 487-1 353) and 500 (CI: 250-760) dengue cases averted annually per million population in Mexico and Nicaragua, respectively, compared to control communities. The ICER in Mexico was US$29 618 (CI: 13 869-66 898) per DALY averted, or 3.0 times per capita GDP. For Nicaragua, the ICER was US$29 196 (CI: 14294-72181) per DALY averted, or 16.9 times per capita GDP. INTERPRETATION Camino Verde, as implemented in the research context, was marginally cost-effective in Mexico, and not cost-effective in Nicaragua, from a healthcare sector perspective. Nicaragua's low per capita GDP and the use of grant-funded management personnel weakened the cost-effectiveness results. Achieving efficiencies by incorporating Camino Verde activities into existing public health programs would make Camino Verde cost-effective.",2020,Nicaragua's low per capita GDP and use of extra-governmental management personnel weakened the cost-effectiveness results.,"['Nicaragua and Mexico', 'Managua, Nicaragua, and in three coastal regions in Guerrero, Mexico (75 intervention and 75 control clusters), Camino Verde used non-governmental community health workers, called brigadistas, to support community mobilization']",['community mobilization (Camino Verde'],['incremental cost-effectiveness ratios (ICER) for costs per disability-adjusted life-year (DALYs) averted and conducted probabilistic sensitivity analyses'],"[{'cui': 'C0028002', 'cui_str': 'Nicaragua'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0896247,Nicaragua's low per capita GDP and use of extra-governmental management personnel weakened the cost-effectiveness results.,"[{'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Tschampl', 'Affiliation': 'Schneider Institutes for Health Policy, The Heller School for Social Policy and Management, Brandeis University, Waltham, MA, USA.'}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Undurraga', 'Affiliation': 'Escuela de Gobierno, Pontificia Universidad Católica de Chile, Santiago, RM, Chile.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ledogar', 'Affiliation': 'CIET International, New York, USA.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Coloma', 'Affiliation': 'Division of Infectious Diseases and Vaccinology, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Legorreta-Soberanis', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Mexico.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Paredes-Solís', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arosteguí', 'Affiliation': 'CIET, Nicaragua.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Hernández-Álvarez', 'Affiliation': 'CIET, Nicaragua.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Harris', 'Affiliation': 'Division of Infectious Diseases and Vaccinology, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Mexico; Department of Family Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Shepard', 'Affiliation': 'Schneider Institutes for Health Policy, The Heller School for Social Policy and Management, Brandeis University, Waltham, MA, USA. Electronic address: shepard@brandeis.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.026'] 111,32179241,Anthocyanin supplementation improves anti-oxidative and anti-inflammatory capacity in a dose-response manner in subjects with dyslipidemia.,"BACKGROUND Anthocyanins, one of the major plant bioactive substances, possess anti-oxidative and anti-inflammatory capacity. However, their dose-response relationship has remained unclear. The present study investigated the dose-response relationship of anthocyanins with oxidative stress and inflammation in subjects with dyslipidemia. DESIGN and Participants: A total of 169 participants with dyslipidemia were randomly assigned to placebo (n = 43), anthocyanins 40 mg/day (n = 44), 80 mg/day (n = 40), or 320 mg/day (n = 42) groups. Urine 8-iso-prostaglandin F 2 α (8-iso-PGF 2 α ), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and serum malonaldehyde (MDA), total superoxide dismutase (T-SOD), UA (uric acid), interleukin (IL)-6, IL-10, tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP) were measured at baseline, at 6 weeks, and at 12 weeks. RESULTS Anthocyanin supplementation (320 mg/day) for 6 weeks significantly improved T-SOD versus baseline (P < 0.05). A slight reduction in serum IL-6, TNF-α, and urine 8-iso-PGF 2 α from the baseline was observed at 12 weeks in the group receiving 40 mg/day anthocyanins. Anthocyanins (80 mg/day) significantly reduced serum IL-6 (-20%), TNF-α (-11%) and urine 8-iso-PGF 2 α (-27%) versus baseline (P < 0.05). Moreover, 320 mg/day anthocyanin supplementation reduced serum IL-6 (-40%), TNF-α (-21%), MDA (-20%) and urine 8-iso-PGF 2 α (-37%) and 8-OHdG (-36%) than 80 mg/day and 40 mg/day anthocyanins, P value < 0.05. Anthocyanin supplementation has dose-response relationships with decreased inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA (P for trend, <0.05). Furthermore, a strong positive correlation was observed between the changes in the urine 8-iso-PGF 2 α , 8-OHdG levels and serum IL-6 levels in subjects from anthocyanin groups after 12 weeks of treatment. CONCLUSIONS Supplementation of anthocyanins for 12 weeks positively improved the anti-oxidative and anti-inflammatory capacity in a dose-response manner in individuals with dyslipidemia.",2020,"Anthocyanin supplementation has dose-response relationships with decreased inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA (P for trend, <0.05).","['subjects with dyslipidemia', '169 participants with dyslipidemia', 'individuals with dyslipidemia', 'and Participants']","['Anthocyanins', 'Anthocyanin supplementation', 'anthocyanins 40\xa0mg/day', 'placebo', 'anthocyanins']","['serum IL-6, TNF-α, and urine 8-iso-PGF 2 α', ""Urine 8-iso-prostaglandin F 2 α (8-iso-PGF 2 α ), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and serum malonaldehyde (MDA), total superoxide dismutase (T-SOD), UA (uric acid), interleukin (IL)-6, IL-10, tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP"", 'TNF-α', 'serum IL-6', 'inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA', 'T-SOD', 'urine 8-iso-PGF 2 α , 8-OHdG levels and serum IL-6 levels', 'anti-oxidative and anti-inflammatory capacity']","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0042037'}, {'cui': 'C1528569', 'cui_str': '8-isoprostaglandin PGF2beta'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0033561', 'cui_str': 'PGF'}, {'cui': 'C0050078', 'cui_str': ""2'-deoxy-8-oxo-7,8-dihydroguanosine""}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",169.0,0.105368,"Anthocyanin supplementation has dose-response relationships with decreased inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA (P for trend, <0.05).","[{'ForeName': 'Hanyue', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: zhanghy97@mail2.sysu.edu.cn.'}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: xuzhliang3@mail2.sysu.edu.cn.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: zhaohw5@mail2.sysu.edu.cn.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: wangxu25@mail2.sysu.edu.cn.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: pangj7@mail2.sysu.edu.cn.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: liqing45@mail2.sysu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, Guangdong Province, PR China; Department of Nutrition, School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, Guangdong Province, PR China. Electronic address: yangyan3@mail.sysu.edu.cn.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, Guangdong Province, PR China. Electronic address: lingwh@mail.sysu.edu.cn.'}]",Redox biology,['10.1016/j.redox.2020.101474'] 112,30277101,Characterizing the kinetics of lymphocytosis in patients with chronic lymphocytic leukemia treated with single-agent ibrutinib.,"Increased absolute lymphocyte count (ALC) is a key feature of chronic lymphocytic leukemia (CLL) but is also observed during treatment with B-cell receptor pathway inhibitors including ibrutinib, a first-in-class inhibitor of Bruton's tyrosine kinase. In patients with CLL treated with single-agent ibrutinib in two multicenter, open-label, randomized, phase 3 studies (RESONATE-2, NCT01722487; RESONATE, NCT01578707), lymphocytosis was observed in 77 of 136 (57%) patients treated in first-line and 133 of 195 (69%) relapsed/refractory patients. On treatment, lymphocytosis resolved in 95% of patients in the first-line and 94% in the relapsed/refractory setting. The median duration of lymphocytosis was 12 and 14 weeks in the first-line and relapsed/refractory settings, respectively. Lymphocytosis is a common and predictable pharmacodynamic effect of ibrutinib treatment, and in the absence of other signs of progression, does not represent disease progression. Lymphocytosis resolves in the majority of patients and does not require interruption or discontinuation of ibrutinib therapy.",2019,"On treatment, lymphocytosis resolved in 95% of patients in the first-line and 94% in the relapsed/refractory setting.",['patients with chronic lymphocytic leukemia treated with single-agent ibrutinib'],[],"['absolute lymphocyte count (ALC', 'lymphocytosis', 'median duration of lymphocytosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]",[],"[{'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0024282', 'cui_str': 'Lymphocytosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0169664,"On treatment, lymphocytosis resolved in 95% of patients in the first-line and 94% in the relapsed/refractory setting.","[{'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'a CLL Research and Treatment Program , Zucker School of Medicine at Hofstra/Northwell , Lake Success , NY , USA.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'b Department of Leukemia , The University of Texas MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'c Division of Hematology, Department of Internal Medicine , The Ohio State University Comprehensive Cancer Center , Columbus , OH , USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'd Department of Haematology , The Leeds Teaching Hospitals, St. James University Hospital , Leeds , UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'e Pharmacyclics LLC, an AbbVie Company , Sunnyvale , CA , USA.'}, {'ForeName': 'Joi', 'Initials': 'J', 'LastName': 'Ninomoto', 'Affiliation': 'e Pharmacyclics LLC, an AbbVie Company , Sunnyvale , CA , USA.'}, {'ForeName': 'Danelle F', 'Initials': 'DF', 'LastName': 'James', 'Affiliation': 'e Pharmacyclics LLC, an AbbVie Company , Sunnyvale , CA , USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'f Department of Medicine , University of California San Diego, Moores Cancer Center , San Diego , CA , USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2018.1512710'] 113,30759357,Short-term Effects of Manual Therapy in Patients After Surgical Fixation of Ankle and/or Hindfoot Fracture: A Randomized Clinical Trial.,"BACKGROUND Patients with surgical fixation of ankle and/or hindfoot fractures often experience decreased range of motion and loss of function following surgery and postsurgical immobilization, yet there is minimal evidence to guide care for these patients. OBJECTIVES To assess whether manual therapy may provide short-term improvements in range of motion, muscle stiffness, gait, and balance in patients who undergo operative fixation of an ankle and/or hindfoot fracture. METHODS In this multisite, double-blind randomized clinical trial, 72 consecutive patients who underwent open reduction internal fixation of an ankle and/or hindfoot fracture and were receiving physical therapy treatment of exercise and gait training were randomized to receive either impairment-based manual therapy (manual therapy group) or a sham manual therapy treatment of light soft tissue mobilization and proximal tibiofibular joint mobilizations (control group). Participants in both groups received 3 treatment sessions over 7 to 10 days, and outcomes were assessed immediately post intervention. Outcomes included ankle joint range of motion, muscle stiffness, gait characteristics, and balance measures. Group-by-time effects were compared using linear mixed modeling. RESULTS There were no significant differences between the manual therapy and control groups for range of motion, gait, or balance outcomes. There was a significant difference from baseline to the final follow-up in resting gastrocnemius muscle stiffness between the manual therapy and control groups (-47.9 N/m; 95% confidence interval: -86.1, -9.8; P = .01). There was no change in muscle stiffness for the manual therapy group between baseline and final follow-up, whereas muscle stiffness increased in the control group by 6.4%. CONCLUSION A brief course of manual therapy consisting of 3 treatment sessions over 7 to 10 days did not lead to better short-term improvement than the application of sham manual therapy for most clinical outcomes in patients after ankle and/or hindfoot fracture who were already being treated with exercise and gait training. Our results, however, suggest that manual therapy might decrease aberrant resting muscle stiffness after ankle and/or hindfoot surgical fixation. LEVEL OF EVIDENCE Therapy, level 2. J Orthop Sports Phys Ther 2019;49(5):310-319. Epub 13 Feb 2019. doi:10.2519/jospt.2019.8864 .",2019,"There was no change in muscle stiffness for the manual therapy group between baseline and final follow-up, whereas muscle stiffness increased in the control group by 6.4%. ","['patients who undergo operative fixation of an ankle and/or hindfoot fracture', 'Patients with surgical fixation of ankle and/or hindfoot fractures', '72 consecutive patients who underwent open reduction internal fixation of an ankle and/or hindfoot fracture and were receiving physical therapy treatment of exercise and gait training', 'patients after ankle and/or hindfoot fracture who were already being treated with exercise and gait training', 'Patients', 'Epub 13', 'Ankle and/or Hindfoot Fracture']","['impairment-based manual therapy (manual therapy group) or a sham manual therapy treatment of light soft tissue mobilization and proximal tibiofibular joint mobilizations (control group', 'sham manual therapy', 'J Orthop Sports', 'Manual Therapy']","['muscle stiffness', 'ankle joint range of motion, muscle stiffness, gait characteristics, and balance measures', 'resting gastrocnemius muscle stiffness', 'range of motion, gait, or balance outcomes', 'range of motion, muscle stiffness, gait, and balance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",72.0,0.0369584,"There was no change in muscle stiffness for the manual therapy group between baseline and final follow-up, whereas muscle stiffness increased in the control group by 6.4%. ","[{'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Albin', 'Affiliation': ''}, {'ForeName': 'Shane L', 'Initials': 'SL', 'LastName': 'Koppenhaver', 'Affiliation': ''}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Marcus', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Dibble', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cornwall', 'Affiliation': ''}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8864'] 114,32377773,Discoloration of surface sealants by plaque disclosing solution.,"PURPOSE Surface sealants are widely used as a prevention strategy and are indicated for young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning. The aim of this study was to evaluate discoloration of surface sealants by plaque disclosing solutions and to test to what extent this discoloration can be reduced again by professional tooth cleaning. METHODS In all, 96 extracted lesion-free human teeth were randomly assigned to treatment with either Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal™ (OS; Reliance Orthodontic Products, Itasca, IL, USA). Color evaluations after application of the plaque disclosing solution Mira-2-Ton® (Hager & Werken, Duisburg, Germany) were performed using a clinical spectrophotometer. Staining and polishing were repeated once. Color differences (∆E) above 3.77 were regarded as clinically relevant. RESULTS All sealants showed high, clinically relevant ∆E values after the first staining. Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold. Polishing on OS-treated teeth only slightly reduced ∆E values. After professional tooth cleaning both PS and OS showed clinically relevant ∆E values. CONCLUSION Surface sealants show clinically relevant discoloration after exposure to plaque disclosing solution under in vitro conditions. Such discolorations could not be removed by professional tooth cleaning. Thus, in clinical practice, plaque disclosing solutions might cause esthetic deficits in surface sealant-treated teeth. The impact of plaque disclosing solutions under clinical conditions (e.g., in the presence of saliva and by various aspects of a person's nutrition) should be investigated in clinical studies.",2020,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","['young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning', '96 extracted lesion-free human teeth']","['Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal']",['∆E values'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1570472', 'cui_str': 'Pro Seal'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}]",96.0,0.0759057,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Gözde', 'Initials': 'G', 'LastName': 'Şen', 'Affiliation': 'MVZ Dentale Praxisklinik, Dr. Dilling & Kollegen GmbH, Fleiner Straße\xa03, 74072, Heilbronn, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Deurer', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zingler', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00227-5'] 115,32383548,Comparative physicochemical stability and clinical anti-wrinkle efficacy of transdermal emulgel preparations of 5% sodium ascorbyl phosphate and or ascorbic acid on human volunteers.,"OBJECTIVES Antioxidant containing cosmeceuticals are commonly prescribed products in treating wrinkles and revitalizing the skin. The aim of this study was the comparative evaluation of physicochemical stability and clinical anti-wrinkle efficacy of transdermal emulgel preparations of sodium ascorbyl phosphate (SAP) and ascorbic acid (AA) on human volunteers. METHODS Emulgel preparations containing 5% of (SAP) and or (AA) were prepared. HPLC analysis was performed for stability evaluations. Clinical anti-wrinkle efficacy of the formulations was examined on human healthy volunteers in crow's feet area. Elasticity and digital images were recorded before and after treatment. RESULTS Formulations with added antioxidants and kept in the refrigerator exhibited better stability characteristics. Two-sided blind study and placebo-controlled study showed that both actives were effective in wrinkles depth reduction and also elasticity enhancement but statistically significant difference in the efficacy of the products was not observed. CONCLUSION Formulations containing (AA) and or (SAP) both improved elasticity and wrinkles of the skin almost by the same extent, and it is necessary to add antioxidant stabilizing agents to both preparations to reach a desired stability.",2020,"CONCLUSION Formulations containing (AA) and or (SAP) both improved elasticity and wrinkles of the skin almost by the same extent","[""human healthy volunteers in crow's feet area"", 'human volunteers', 'Emulgel preparations containing 5% of (SAP) and or (AA) were prepared']","['sodium ascorbyl phosphate (SAP) and ascorbic acid (AA', 'transdermal emulgel preparations of 5% sodium ascorbyl phosphate and or ascorbic acid', 'Formulations containing (AA) and or (SAP', 'placebo']","['wrinkles depth reduction', 'Elasticity and digital images']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet""}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1814855', 'cui_str': 'Sodium Ascorbyl Phosphate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C1814855', 'cui_str': 'Sodium Ascorbyl Phosphate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",2.0,0.0434198,"CONCLUSION Formulations containing (AA) and or (SAP) both improved elasticity and wrinkles of the skin almost by the same extent","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Skin Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Ranjkesh', 'Affiliation': 'Department of Dermatology, Sina Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahabaddin', 'Initials': 'S', 'LastName': 'Akbari Hamed', 'Affiliation': 'Department of Plasma Physics, Sahand university of Technology, Tabriz, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Monajjemzadeh', 'Affiliation': 'Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13471'] 116,32379976,The Benefits of T'ai Chi for Older Adults with Chronic Back Pain: A Qualitative Study.,"Objective: To determine the perceived benefits of t'ai chi in older adults with chronic low-back pain (cLBP). Design: A qualitative analysis from a randomized controlled feasibility trial. Subjects: Eighteen participants (65+ years old) with cLBP of at least moderate intensity. Intervention: A 36-week intervention beginning with twice weekly classes for 12 weeks, weekly classes for 6 weeks, biweekly classes for 6 weeks, and monthly classes for 12 weeks. Participants were asked to practice at home on nonclass days and videos were provided to assist in that process. Outcome Measures: Participants in the focus groups were asked to provide feedback on their experiences with the study as well as the benefits of their t'ai chi practice. We used demographic and class attendance data to describe the sample. Results: Regarding the benefits of t'ai chi practice, five major themes were identified: functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning t'ai chi , and the integration of t'ai chi into daily activities. The most common functional benefits were improvements in balance, flexibility, leg strength, and posture. Some reported pain reduction or pain relief, but others did not. Increased relaxation, mindfulness, and a sense of connectedness were subthemes that emerged from psychospiritual benefits. Social support benefits included motivation to attend class and group support while learning a new skill. Finally, improved body awareness allowed participants to integrate t'ai chi skills into their daily activities. Conclusions: This qualitative analysis demonstrates the multifaceted benefits of t'ai chi for older adults living with cLBP.",2020,"The most common functional benefits were improvements in balance, flexibility, leg strength, and posture.","['Subjects: Eighteen participants (65+ years old) with cLBP of at least moderate intensity', 'older adults living with cLBP', 'older adults with chronic low-back pain (cLBP', 'Older Adults with Chronic Back Pain']","[""T'ai Chi"", ""t'ai chi practice""]","['pain reduction or pain relief', ""functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning t'ai chi , and the integration of t'ai chi into daily activities"", 'balance, flexibility, leg strength, and posture']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",,0.0522767,"The most common functional benefits were improvements in balance, flexibility, leg strength, and posture.","[{'ForeName': 'Tamsin L', 'Initials': 'TL', 'LastName': 'Lee', 'Affiliation': 'Department of Child, Family and Population Health Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente WA Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'Hawkes', 'Affiliation': 'Kaiser Permanente WA Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Phelan', 'Affiliation': 'Department of Medicine and Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Turner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0455'] 117,32383771,"Does an FSH surge at the time of hCG trigger improve IVF/ICSI outcomes? A randomized, double-blinded, placebo-controlled study.","STUDY QUESTION Does an artificially induced FSH surge at the time of hCG trigger improve IVF/ICSI outcomes? SUMMARY ANSWER An additional FSH bolus administered at the time of hCG trigger has no effect on clinical pregnancy rate, embryo quality, fertilization rate, implantation rate and live birth rate in women undergoing the long GnRH agonist (GnRHa) protocol for IVF/ICSI. WHAT IS KNOWN ALREADY Normal ovulation is preceded by a surge in both LH and FSH. Few randomized clinical trials have specifically investigated the role of the FSH surge. Some studies indicated that FSH given at hCG ovulation trigger boosts fertilization rate and even prevents ovarian hyperstimulation syndrome (OHSS). STUDY DESIGN, SIZE, DURATION This was a randomized, double-blinded, placebo-controlled trial conducted at a single IVF center, from June 2012 to November 2013. A sample size calculation indicated that 347 women per group would be adequate. A total of 732 women undergoing IVF/ICSI were randomized, using electronically randomized tables, to the intervention or placebo groups. Participants and clinical doctors were blinded to the treatment allocation. PARTICIPANTS/MATERIALS, SETTING, METHODS Patients aged ≤42 years who were treated with IVF/ICSI owing to tubal factor, male factor, unexplained, endometriosis and multiple factors were enrolled in this trial. Subjects all received a standard long GnRHa protocol for IVF/ICSI and hCG 6000-10 000 IU to trigger oocyte maturation. A total of 364 and 368 patients were randomized to receive a urinary FSH (uFSH) bolus (6 ampules, 450 IU) and placebo, respectively, at the time of the hCG trigger. The primary outcome measure was clinical pregnancy rate. The secondary outcome measures were FSH level on the day of oocyte retrieval, number of oocytes retrieved, good-quality embryo rate, live birth rate and rate of OHSS. MAIN RESULTS AND THE ROLE OF CHANCE There were no significant differences in the baseline demographic characteristics between the two study groups. There were also no significant differences between groups in cycle characteristics, such as the mean number of stimulation days, total gonadotrophin dose and peak estradiol. The clinical pregnancy rate was 51.6% in the placebo group and 52.7% in the FSH co-trigger group, with an absolute rate difference of 1.1% (95% CI -6.1% to 8.3%). The number of oocytes retrieved was 10.47 ± 4.52 and 10.74 ± 5.01 (P = 0.44), the rate of good-quality embryos was 37% and 33.9% (P = 0.093) and the implantation rate was 35% and 36% (P = 0.7) in the placebo group and the FSH co-trigger group, respectively. LIMITATIONS, REASONS FOR CAUTION This was a single-center study, which may limit its effectiveness. The use of uFSH is a limitation, as this is not the same as the natural FSH. We did not collect follicular fluid for further study of molecular changes after the use of uFSH as a co-trigger. WIDER IMPLICATIONS OF THE FINDINGS Based on previous data and our results, an additional FSH bolus administered at the time of hCG trigger has no benefit on clinical pregnancy rates in women undergoing the long GnRHa protocol in IVF/ICSI: a single hCG trigger is sufficient. STUDY FUNDING/COMPETING INTEREST(S) This study was supported by the National Key Research and Development Program of China (2016YFC1000205); Sun Yat-Sen University Clinical Research 5010 Program (2016004); the Science and Technology Project of Guangdong Province (2016A020216011 and 2017A020213028); and Science Technology Research Project of Guangdong Province (S2011010004662). There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-12002246). TRIAL REGISTRATION DATE 20 May 2012. DATE OF FIRST PATIENT’S ENROLMENT 10 June 2012.",2020,"An additional FSH bolus administered at the time of hCG trigger has no effect on clinical pregnancy rate, embryo quality, fertilization rate, implantation rate and live birth rate in women undergoing the long GnRH agonist (GnRHa) protocol for IVF/ICSI. ","['’S ENROLMENT\n\n\n10 June 2012', '732 women undergoing IVF/ICSI', 'Participants and clinical doctors', 'A total of 364 and 368 patients', 'Patients aged ≤42 years who were treated with IVF/ICSI owing to tubal factor, male factor, unexplained, endometriosis and multiple factors were enrolled in this trial', 'single IVF center, from June 2012 to November 2013', 'women undergoing the long GnRHa protocol in IVF']","['ICSI', 'FSH', 'standard long GnRHa protocol for IVF/ICSI and hCG 6000-10\u2009000 IU to trigger oocyte maturation', 'urinary FSH (uFSH', 'uFSH', 'placebo']","['clinical pregnancy rate', 'implantation rate', 'FSH level on the day of oocyte retrieval, number of oocytes retrieved, good-quality embryo rate, live birth rate and rate of OHSS', 'clinical pregnancy rate, embryo quality, fertilization rate, implantation rate and live birth rate', 'clinical pregnancy rates', 'number of oocytes', 'ovarian hyperstimulation syndrome', 'mean number of stimulation days, total gonadotrophin dose and peak estradiol', 'rate of good-quality embryos']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]",732.0,0.758645,"An additional FSH bolus administered at the time of hCG trigger has no effect on clinical pregnancy rate, embryo quality, fertilization rate, implantation rate and live birth rate in women undergoing the long GnRH agonist (GnRHa) protocol for IVF/ICSI. ","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Qiu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Dongzi', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Qingxue', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Medicine Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa087'] 118,32387123,Re: Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery in Patients with High Grade Upper Tract Urothelial Carcinoma.,,2020,,['Patients with High Grade Upper Tract Urothelial Carcinoma'],['Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.0194814,,"[{'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Califano', 'Affiliation': 'Department of Urology, Bichat-Claude Bernard Hospital Paris Descartes University, Paris, France; Urology Unit, Department of Neurosciences, Reproductive Sciences and Odontostomatology, Federico II University of Naples, Naples, Italy. Electronic address: gianl.califano2@gmail.com.'}, {'ForeName': 'Evanguelos', 'Initials': 'E', 'LastName': 'Xylinas', 'Affiliation': 'Department of Urology, Bichat-Claude Bernard Hospital Paris Descartes University, Paris, France. Electronic address: evanguelosxylinas@hotmail.com.'}]",European urology,['10.1016/j.eururo.2020.04.008'] 119,32097899,A machine learning-based real-time tumor tracking system for fluoroscopic gating of lung radiotherapy.,"To improve respiratory-gated radiotherapy accuracy, we developed a machine learning approach for markerless tumor tracking and evaluated it using lung cancer patient data. Digitally reconstructed radiography (DRR) datasets were generated using planning 4DCT data. Tumor positions were selected on respective DRR images to place the GTV center of gravity in the center of each DRR. DRR subimages around the tumor regions were cropped so that the subimage size was defined by tumor size. Training data were then classified into two groups: positive (including tumor) and negative (not including tumor) samples. Machine learning parameters were optimized by the extremely randomized tree method. For the tracking stage, a machine learning algorithm was generated to provide a tumor likelihood map using fluoroscopic images. Prior probability tumor positions were also calculated using the previous two frames. Tumor position was then estimated by calculating maximum probability on the tumor likelihood map and prior probability tumor positions. We acquired treatment planning 4DCT images in eight patients. Digital fluoroscopic imaging systems on either side of the vertical irradiation port allowed fluoroscopic image acquisition during treatment delivery. Each fluoroscopic dataset was acquired at 15 frames per second. We evaluated the tracking accuracy and computation times. Tracking positional accuracy averaged over all patients was 1.03 ± 0.34 mm (mean ± standard deviation, Euclidean distance) and 1.76 ± 0.71 mm ([Formula: see text] percentile). Computation time was 28.66 ± 1.89 ms/frame averaged over all frames. Our markerless algorithm successfully estimated tumor position in real time.",2020,"Tracking positional accuracy averaged over all patients was 1.03 ± 0.34 mm (mean ± standard deviation, Euclidean distance) and 1.76 ± 0.71 mm ([Formula: see text] percentile).",['eight patients'],"['machine learning approach', 'machine learning-based real-time tumor tracking system']","['Computation time', 'Tracking positional accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1738334', 'cui_str': 'Tracking system'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0164397,"Tracking positional accuracy averaged over all patients was 1.03 ± 0.34 mm (mean ± standard deviation, Euclidean distance) and 1.76 ± 0.71 mm ([Formula: see text] percentile).","[{'ForeName': 'Yukinobu', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Corporate Research and Development Center, Toshiba Corporation, Kanagawa, Japan.'}, {'ForeName': 'Ryusuke', 'Initials': 'R', 'LastName': 'Hirai', 'Affiliation': ''}, {'ForeName': 'Kyoka', 'Initials': 'K', 'LastName': 'Kobuna', 'Affiliation': ''}, {'ForeName': 'Akiyuki', 'Initials': 'A', 'LastName': 'Tanizawa', 'Affiliation': ''}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': ''}]",Physics in medicine and biology,['10.1088/1361-6560/ab79c5'] 120,32393496,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection.","For patients hospitalized with severe influenza A virus infection, morbidity and mortality remain high. MHAA4549A, a human monoclonal antibody targeting the influenza A virus hemagglutinin stalk, has demonstrated pharmacological activity in animal studies and in a human influenza A challenge study. We evaluated the safety and efficacy of MHAA4549A plus oseltamivir against influenza A virus infection in hospitalized patients. The CRANE trial was a phase 2b randomized, double-blind, placebo-controlled study of single intravenous (i.v.) doses of placebo, 3,600 mg MHAA4549A, or 8,400 mg MHAA4549A each combined with oral oseltamivir (+OTV) in patients hospitalized with severe influenza A virus infection. Patients, enrolled across 68 clinical sites in 18 countries, were randomized 1:1:1. The primary outcome was the median time to normalization of respiratory function, defined as the time to removal of supplemental oxygen support to maintain a stable oxygen saturation (SpO 2 ) of ≥95%. Safety, pharmacokinetics, and effects on influenza viral load were also assessed. One hundred sixty-six patients were randomized and analyzed during a preplanned interim analysis. Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV, 4.28 days; 3,600 mg MHAA4549A+OTV, 2.78 days; 8,400 mg MHAA4549A+OTV, 2.65 days), nor did it improve other secondary clinical outcomes. Adverse event frequency was balanced across cohorts. MHAA4549A+OTV did not further reduce viral load versus placebo+OTV. In hospitalized patients with influenza A virus infection, MHAA4549A did not improve clinical outcomes over OTV alone. Variability in patient removal from oxygen supplementation limited the utility of the primary endpoint. Validated endpoints are needed to assess novel treatments for severe influenza A virus infection. (This study has been registered at ClinicalTrials.gov under registration no. NCT02293863.).",2020,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","['patients hospitalized with severe influenza A. Patients, enrolled across 68 clinical sites in 18 countries', 'patients hospitalized with severe influenza A infection', 'hospitalized patients', '166 patients']","['MHAA4549A plus oseltamivir', 'placebo, 3600-mg, or 8400-mg MHAA4549A together with oral oseltamivir (+OTV', 'MHAA4549A', 'MHAA4549A+OTV', 'placebo+OTV, MHAA4549A+OTV', 'placebo']","['median time to normalization of respiratory function defined as the time to removal of supplemental oxygen support to maintain a stable SpO 2 ≥ 95', 'time to normalization of respiratory function', 'Safety, pharmacokinetics, and effects on influenza viral load', 'safety and efficacy', 'Adverse event frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C5191361', 'cui_str': '166'}]","[{'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",166.0,0.65193,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA lim.jeremy@gene.com.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Translational Medicine, Infectious Diseases Research Unit, Lund University, Malmö, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Nimer', 'Initials': 'N', 'LastName': 'Assy', 'Affiliation': 'Galilee Medical Center, Department of Internal Med A, The Azrieli Faculty of Medicine, Nahariya, Israel.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Aide', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Melicent C', 'Initials': 'MC', 'LastName': 'Peck', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Galanter', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Newton', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Tavel', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00352-20'] 121,32333540,[Effect and safety of electroacupuncture analgesia at the latent stage of labor on the epidural analgesia].,"OBJECTIVE To investigate the effect of electroacupuncture (EA) analgesia at the latent stage of labor on epidural analgesia, labor outcome and neonatal score so as to provide the reference to the clinical labor analgesia. METHODS According to the random number table, 104 primipara of vaginal delivery were divided into three groups, named an EA group (37 cases), a sham-EA group (36 cases) and an epidural block group (31 cases). In the EA group, when the cervix opened up by 1 cm, Han's acupoint nerve stimulation apparatus was attached to bilateral Hegu (LI4) and bilateral Sanyinjiao (SP6) to achieve EA analgesia till the active stage (the cervix up 3 cm). In the sham-EA group, the procedure was same as the EA group, but with the sham-stimulation. In the epidural block, EA was not used in intervention. When the cervix opened up 3 cm, the epidural block and the patient-controlled epidural analgesia were all adopted in each group. The score of visual analogue scale (VAS) and the dosage of Sufentanil and Ropivacaine in patient-controlled analgesia pump at the different time points were compared among the groups. Respectively, in 1 h of EA stimulation (T1), 2 h of EA stimulation (T2), at the moment of epidural block (T3) and the complete open of the cervix (T6), the venous blood sample was collected to determine the concentration of beta-endorphin (beta-EP), and the use time of oxytocin, the bleeding amount and the state of newborn were recorded. RESULTS There was no statistical difference in immediate of EA stimulation (T0) among the groups in VAS score ( P >0.05). But, in T1 to T6, VAS score in the EA group was reduced obviously as compared with the sham-EA group and the epidural block group separately ( P <0.05). There was no statistical difference in the use time of oxytocin among the three groups ( P >0.05). In the sham-EA group and the epidural block group, bleeding amount during labor and in 24 h after labor was all higher than that of the EA group ( P <0.05). In each group, the concentration of beta-EP in T3 and T6 was increased obviously as compared with that in T1 and T2 respectively ( P <0.05). In the EA group, the concentration of beta-EP in T1 to T3 and in T6 was higher than that in sham-EA group and the epidural block group respectively ( P <0.05). The dosage of Ropivacaine and Sufentanil in the EA group was less than that in either the sham-EA group or the epidural block group ( P <0.05). There was no significant difference in amniotic fluid turbidity rate and Apgar score among the three groups ( P >0.05). CONCLUSION Electroacupuncture analgesia at the latent stage of labor effectively relieves labor pain of primipara, increases the concentration of beta-EP, enhances the effect of epidural block analgesia, reduces labor bleeding and has no side effect on newborn. The combination of electroacupuncture analgesia and the epidural anesthesia in the latent stage is applicable in the whole process of labor.",2020,"In the EA group, the concentration of beta-EP in T1 to T3 and in T6 was higher than that in sham-EA group and the epidural block group respectively ( P <0.05).",['104 primipara of vaginal delivery'],"['Electroacupuncture analgesia', 'electroacupuncture (EA) analgesia', 'Ropivacaine and Sufentanil', 'epidural block', 'electroacupuncture analgesia', 'Sufentanil and Ropivacaine', 'electroacupuncture analgesia and the epidural anesthesia', 'sham-EA']","['VAS score', 'bleeding amount', 'concentration of beta-EP in T3 and T6', 'use time of oxytocin', 'immediate of EA stimulation (T0', 'concentration of beta-EP', 'amniotic fluid turbidity rate and Apgar score', 'labor bleeding', 'concentration of beta-endorphin (beta-EP), and the use time of oxytocin, the bleeding amount and the state of newborn', 'labor pain', 'score of visual analogue scale (VAS']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005210', 'cui_str': 'Beta endorphin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}, {'cui': 'C4319582', 'cui_str': 'Turbidity (property)'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0388991,"In the EA group, the concentration of beta-EP in T1 to T3 and in T6 was higher than that in sham-EA group and the epidural block group respectively ( P <0.05).","[{'ForeName': 'Mao-Jun', 'Initials': 'MJ', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Linshui County People's Hospital, Linshui 638500, Sichuan Province, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Linshui County People's Hospital, Linshui 638500, Sichuan Province, China.""}, {'ForeName': 'Bin-Xiu', 'Initials': 'BX', 'LastName': 'Wei', 'Affiliation': ""Department of Anesthesiology, Linshui County People's Hospital, Linshui 638500, Sichuan Province, China.""}, {'ForeName': 'Qiu-Xia', 'Initials': 'QX', 'LastName': 'Deng', 'Affiliation': ""Department of Anesthesiology, Linshui County People's Hospital, Linshui 638500, Sichuan Province, China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Linshui County People's Hospital, Linshui 638500, Sichuan Province, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou 646000, Sichuan Province.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190448'] 122,32333541,[Jingjin needling improves facial nerve function and psychosomatic function in Hunt facial para-lysis patients].,"OBJECTIVE To observe the clinical effectiveness of Jingjin (muscle region) needling in the treatment of Hunt facial paralysis (HFP). METHODS A total of 80 HFP patients were randomly divided into acupuncture and medication groups ( n ＝40 cases/group). Jingjin needling was applied to Yangbai(GB14) to Shangxing (GV23), Touwei (ST8), Cuanzhu (BL2), Sizhukong (TE23，penetrative needling), Dicang (ST4) to Jiache (ST6, penetrative needling), Yingxiang(LI20) and Xiaguan(ST7), Hegu(LI4), Yifeng (TE17), Yuyao (EX-HN 4), and Shenmai (BL62), with the needles retained for 30 min. The treatment was conducted once daily, with 10 consecutive days being a therapeutic course, and 3 courses altogether. Patients of the medication group received oral administration of Prednisone acetate (12 days), Acyclovir (7 days), intramuscular injection of Vitamin B 12 and Vitamin B 1 (10 days), then, oral administration of Vitamin B 1, successively. The therapeutic effect was assessed by using House-Brackman (H-B) facial function grading system (grade I to VI), traditional Chinese medicine (TCM) sign and symptom score, and facial disability index (FDI) scale including FDI physical function (FDIP, food and water swallowing, speaking-pronouncing, dryness or tearing, and mouth-opening) and FDI social function (FDIS, self-rating anxiety/depression scales), separately. RESULTS After the treatment, the TCM symptom and sign scores for depth of nasolabial groove, nose shrugging, lower lip asymmetry, food retention and post-auricular pain were significantly lower in the medication group ( P <0.05)．After the treatment, the TCM symptom and sign scores for frontal muscle movement, eyelid opening and closing, depth of nasolabial groove, nose shrugging, lower lip asymmetry, cheek blowing, food retention, latissimus cervicalis contraction, taste disorder, hearing hypersensitivity, tears and discomfort and post-auricular pain were significantly lower in the acupuncture group ( P <0.05)．Comparison between two groups showed that the TCM symptom and sign scores for frontal muscle movement, eyelid opening and closing, depth of nasolabial groove, nose shrugging, lower lip asymmetry, cheek blowing, food retention, latissimus cervicalis contraction, taste disorder, hearing hypersensitivity, tears and discomfort and post-auricular pain were significantly lower in the acupuncture group than in the medication group( P <0.05)．The scores of FDIP and FDIS were significantly increased in both groups ( P <0.01) and notably higher in the acupuncture group than in the medication group ( P <0.01) after the treatment. The total effective rate of acupuncture group was 97.5% (39/40), and that of medication group was 72.5% (29/40). The therapeutic effect of the acupuncture group was significantly superior to that of the medication group ( P <0.01)．. CONCLUSION Jingjin needling has a good therapeutic effect in improving facial nerve function, psychosomatic function and clinical signs and symptoms in HFP patients, evidently being better than medication.",2020,"The therapeutic effect of the acupuncture group was significantly superior to that of the medication group ( P <0.01)．. CONCLUSION Jingjin needling has a good therapeutic effect in improving facial nerve function, psychosomatic function and clinical signs and symptoms in HFP patients, evidently being better than medication.","['Hunt facial para-lysis patients', 'Hunt facial paralysis (HFP', '80 HFP patients']","['Jingjin (muscle region) needling', 'Acyclovir (7 days), intramuscular injection of Vitamin B 12 and Vitamin B 1 (10 days), then, oral administration of Vitamin B 1, successively', 'oral administration of Prednisone acetate', 'Jingjin needling was applied to Yangbai(GB14) to Shangxing (GV23), Touwei (ST8), Cuanzhu (BL2), Sizhukong (TE23，penetrative needling), Dicang (ST4) to Jiache (ST6, penetrative needling), Yingxiang(LI20) and Xiaguan(ST7), Hegu(LI4), Yifeng (TE17), Yuyao (EX-HN 4), and Shenmai (BL62', 'acupuncture', 'Jingjin needling', 'acupuncture and medication']","['House-Brackman (H-B) facial function grading system (grade I to VI), traditional Chinese medicine (TCM) sign and symptom score, and facial disability index (FDI) scale including FDI physical function (FDIP, food and water swallowing, speaking-pronouncing, dryness or tearing, and mouth-opening) and FDI social function (FDIS, self-rating anxiety/depression scales), separately', 'facial nerve function, psychosomatic function and clinical signs and symptoms', 'facial nerve function and psychosomatic function', 'total effective rate', 'TCM symptom and sign scores for frontal muscle movement, eyelid opening and closing, depth of nasolabial groove, nose shrugging, lower lip asymmetry, cheek blowing, food retention, latissimus cervicalis contraction, taste disorder, hearing hypersensitivity, tears and discomfort and post-auricular pain', 'FDIP and FDIS', 'TCM symptom and sign scores for depth of nasolabial groove, nose shrugging, lower lip asymmetry, food retention and post-auricular pain']","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0450503', 'cui_str': 'ST6'}, {'cui': 'C0603925', 'cui_str': 'fructus schizandrae, radix ginseng, radix ophiopogonis drug combination'}, {'cui': 'C0450656', 'cui_str': 'BL62'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0234290', 'cui_str': 'Seventh cranial nerve function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0226942', 'cui_str': 'External lower lip'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0007966', 'cui_str': 'Cheek structure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0039338', 'cui_str': 'Disorder of taste'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2316035', 'cui_str': 'Posterior auricular pain'}]",80.0,0.042923,"The therapeutic effect of the acupuncture group was significantly superior to that of the medication group ( P <0.01)．. CONCLUSION Jingjin needling has a good therapeutic effect in improving facial nerve function, psychosomatic function and clinical signs and symptoms in HFP patients, evidently being better than medication.","[{'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Xu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Chun-Xia', 'Initials': 'CX', 'LastName': 'Song', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Xing-Miao', 'Initials': 'XM', 'LastName': 'Quan', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Yu-Lan', 'Initials': 'YL', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Song-Bai', 'Initials': 'SB', 'LastName': 'Wu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190447'] 123,32336479,"Oral Paracetamol vs Oral Ibuprofen in Patent Ductus Arteriosus: A Randomized, Controlled, Noninferiority Trial.","OBJECTIVE To test the hypothesis that oral paracetamol is non-inferior to oral ibuprofen in closing hemodynamically significant patent ductus arteriosus (hsPDA) with an a priori noninferiority (NI) margin of 15%. STUDY DESIGN Multicenter, randomized, controlled, NI trial conducted in level III neonatal intensive care units. Consecutively inborn preterm neonates of <32 weeks of gestation with hsPDA were included. Those with structural heart disease, major malformations, and contraindications for enteral feeding or for administration of study drugs were excluded. Interventions included oral paracetamol in the experimental arm and oral ibuprofen in the active control arm. The primary outcome was closure of hsPDA by 24 hours from the last dose of the study drug. Secondary outcome measures included closure of hsPDA by 24 hours after the first course of the study drug, rate of reopening after the first course, and adverse events associated with the study drug. RESULTS Out of 1250 neonates screened, 161 were randomized. Oral paracetamol was noninferior to oral ibuprofen in closure of hsPDA by both per protocol analysis (62 [95.4%] vs 63 [94%]; relative risk [RR], 1.01 [95% CI, 0.94-1.1]; risk difference [RD], 1.4 [95% CI, -6 to 9]; P = .37) and intention-to-treat analysis (63 [89%] vs 65 [89%]; RR, 0.99 [95% CI, 0.89-1.12]; RD, -0.3 [95% CI, -11 to 10]; P = .47). All adverse events were comparable in the 2 study arms. CONCLUSIONS Oral paracetamol is noninferior to oral ibuprofen for the closure of hsPDA in preterm neonates of <32 weeks of gestation. No difference was observed in the adverse events studied.",2020,"Oral paracetamol was noninferior to oral ibuprofen in closure of hsPDA by both per protocol analysis (62 [95.4%] vs 63 [94%]; relative risk [RR], 1.01 [95% CI, 0.94-1.1]; risk difference [RD], 1.4 [95% CI, -6 to 9]; P = .37) and intention-to-treat analysis (63 [89%] vs 65 [89%]; RR, 0.99","['level III neonatal intensive care units', 'Patent Ductus', 'Out of 1250 neonates screened, 161 were randomized', 'closing hemodynamically significant patent ductus arteriosus (hsPDA', 'Arteriosus', 'Consecutively inborn preterm neonates of <32\xa0weeks of gestation with hsPDA were included', 'preterm neonates of <32\xa0weeks of gestation']","['ibuprofen', 'paracetamol', 'Oral Paracetamol vs Oral Ibuprofen', 'oral paracetamol', 'Oral paracetamol']","['closure of hsPDA by 24\xa0hours after the first course of the study drug, rate of reopening after the first course, and adverse events', 'closure of hsPDA']","[{'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",161.0,0.334695,"Oral paracetamol was noninferior to oral ibuprofen in closure of hsPDA by both per protocol analysis (62 [95.4%] vs 63 [94%]; relative risk [RR], 1.01 [95% CI, 0.94-1.1]; risk difference [RD], 1.4 [95% CI, -6 to 9]; P = .37) and intention-to-treat analysis (63 [89%] vs 65 [89%]; RR, 0.99","[{'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India; Department of Pediatrics, Research and Referral, Army Hospital, New Delhi, India.'}, {'ForeName': 'Rahul Subhash', 'Initials': 'RS', 'LastName': 'Gosavi', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Bogulakunta, Hyderabad, India.'}, {'ForeName': 'Venkataseshan', 'Initials': 'V', 'LastName': 'Sundaram', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: venkatpgi@gmail.com.'}, {'ForeName': 'Tejo Pratap', 'Initials': 'TP', 'LastName': 'Oleti', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Bogulakunta, Hyderabad, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Department of Neonatology, Institute of Child Health, Egmore, Chennai, India.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Kiran', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Bogulakunta, Hyderabad, India.'}, {'ForeName': 'Jogender', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murki', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Bogulakunta, Hyderabad, India.'}, {'ForeName': 'Mangalabharathi', 'Initials': 'M', 'LastName': 'Sundaram', 'Affiliation': 'Department of Neonatology, Institute of Child Health, Egmore, Chennai, India.'}, {'ForeName': 'Shiv Sajan', 'Initials': 'SS', 'LastName': 'Saini', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sourabh', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.01.058'] 124,32283187,Mediators of intervention effects on dietary fat intake in low-income overweight or obese women with young children.,"PURPOSE We investigated whether autonomous motivation and self-efficacy might mediate the association between a lifestyle behavior intervention and dietary fat intake in low-income overweight or obese women with young children. METHODS Participants were randomized to an intervention or comparison group. Intervention participants received a 16-week intervention aimed to prevent weight gain through promotion of stress management, healthy eating and physical activity. During the intervention phase, participants viewed a designated video lesson at home and dialed in a peer support group teleconference every week (weeks 1-4) then every other week (weeks 5-16). Potential mediation effects were analyzed using sequential mixed-effects linear models and path analysis. RESULTS The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001). In other words, autonomous motivation and self-efficacy mediated the association between the lifestyle behavior intervention and dietary fat intake. CONCLUSION To decrease dietary fat intake for low-income overweight or obese women with young children, strategies, such as those promoting peer encouragement, may be warranted in interventions to enhance autonomous motivation and/or practical skills for increasing self-efficacy.",2020,"The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001).","['Participants', 'low-income overweight or obese women with young children']","['16-week intervention aimed to prevent weight gain through promotion of stress management, healthy eating and physical activity', 'lifestyle behavior intervention and dietary fat intake']","['dietary fat intake', 'autonomous motivation', 'self-efficacy', 'higher levels of self-efficacy']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0425440', 'cui_str': 'Dietary fat intake'}]","[{'cui': 'C0425440', 'cui_str': 'Dietary fat intake'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0336699,"The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001).","[{'ForeName': 'Mei-Wei', 'Initials': 'MW', 'LastName': 'Chang', 'Affiliation': 'The Ohio State University College of Nursing, 1585 Neil Avenue, Columbus, OH, 43210, USA. Electronic address: chang.1572@osu.edu.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'The Ohio State University College of Nursing, 1585 Neil Avenue, Columbus, OH, 43210, USA.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Michigan State University College of Nursing, 1355 Bogue St, East Lansing, MI, 48824, USA. Electronic address: lingjiyi@msu.edu.'}, {'ForeName': 'Duane T', 'Initials': 'DT', 'LastName': 'Wegener', 'Affiliation': 'The Ohio State University Department of Psychology, 1835 Neil Avenue, Columbus, OH, 43210, USA. Electronic address: wegener.1@osu.edu.'}, {'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'Michigan State University College of Nursing, 1355 Bogue St, East Lansing, MI, 48824, USA. Electronic address: robbin76@msu.edu.'}]",Appetite,['10.1016/j.appet.2020.104700'] 125,32311521,"A Commentary on the article: Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study, Int J Surg. 2020 Mar 17. pii: S1743-9191(20)30231-4. doi: 10.1016/j.ijsu.2020.03.019.",,2020,,['pii'],['fluorescent imaging during laparoscopic surgery'],['peritoneal perfusion'],"[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0758544,,"[{'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Karimian', 'Affiliation': 'Tehran University of Medical Sciences-TUMS, Iran. Electronic address: faramarz.karimian@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.074'] 126,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE The purpose of this study was to determine if WBV performed concurrently with static stretching was more effective than static stretching alone to increase dorsiflexion ROM (DFROM) in individuals with chronic ankle instability (CAI). DESIGN Controlled laboratory study. PARTICIPANTS Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score) were divided into 3 groups (normative (N), static stretch (SS), and static stretch with vibration (SV)). Participants stretched the triceps surae 4 days/wk for 3 wks. Vibration was imposed at 34 Hz and 1.8 mm. MAIN OUTCOME MEASURES DFROM was assessed in a straight and bent-leg position. RESULTS No differences were detected at any time in the N or SS group, however SS did exhibit large effect sizes with 95% confidence intervals (CI) that did not cross zero from baseline to 3 weeks for both measures. The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2. CONCLUSIONS Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2. ","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2. ","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001'] 127,32387408,"A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in patients with asthma.","INTRODUCTION Mometasone furoate (MF) is the inhaled corticosteroid (ICS) component in the long-acting β 2 -agonist (LABA)/ICS fixed-dose combination of indacaterol/MF, delivered via Breezhaler®, in development for asthma. MF at low (80 μg) and high (320 μg) doses delivered via Breezhaler® is expected to be comparable to MF at low (200 μg) and high (800 μg) doses respectively, delivered via Twisthaler®. METHODS This was a randomized, double-blind, double-dummy, four-week, parallel-group study of 739 adolescents and adults with persistent asthma. Eligible patients were receiving ICS treatment up to the maximum dose per day on a stable regimen for at least four weeks before screening. The study population was enriched for patients who were responsive to ICS therapy. The primary objective of the present study was to show non-inferiority of these doses, i.e. the low (80 μg) and high (320 μg) doses of MF delivered via Breezhaler® once daily, compared with the corresponding low (200 μg) and high (800 μg) doses of MF delivered via Twisthaler® once daily. The primary endpoint was 24 h post-dose trough forced expiratory volume in 1 s (FEV 1 ), after four weeks of treatment in patients with asthma. A secondary objective was to evaluate the efficacy of MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler® in terms of Asthma Control Questionnaire-5 (ACQ-5) after one, two, three and four weeks of treatment. RESULTS The LS mean difference in trough FEV 1 after four weeks of treatment between MF low dose 80 μg (Breezhaler®) and MF low dose 200 μg (Twisthaler®) was 27 mL (95% CI -34, 89); for MF high dose 320 μg (Breezhaler®) and MF high dose 800 μg (Twisthaler®) the difference was 0 mL (95% CI -60, 61). These differences were neither clinically nor statistically significant. All treatment arms provided similar clinically relevant improvements in ACQ-5 after four weeks of treatment compared with baseline. Both treatments showed a similar safety profile with a low incidence of adverse events. CONCLUSION The similarities in effects on lung function and ACQ after four weeks of treatment demonstrate the comparability of MF at low (80 μg) and high (320 μg) doses delivered with Breezhaler® with MF at low (200 μg) and high (800 μg) doses delivered with Twisthaler®, respectively. The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.",2020,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","['739 adolescents and adults with persistent asthma', 'patients with asthma', 'patients who were responsive to ICS therapy']","['ICS', 'MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler®', 'Mometasone furoate (MF', 'MF high dose 800 μg (Twisthaler®', 'mometasone furoate delivered via Breezhaler® or Twisthaler®']","['ACQ-5', 'efficacy and safety', '24h post-dose trough forced expiratory volume in one second (FEV 1 ', 'lung function and ACQ']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",739.0,0.543909,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Demin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patalano', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hederer', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kanniess', 'Affiliation': 'Gemeinschaftspraxis Reinfeld, Reinfeld, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland. Electronic address: hanns-christian.tillmann@novartis.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101919'] 128,32388538,Serotonin differentially modulates the temporal dynamics of the limbic response to facial emotions in male adults with and without autism spectrum disorder (ASD): a randomised placebo-controlled single-dose crossover trial.,"Emotion processing-including signals from facial expressions-is often altered in individuals with autism spectrum disorder (ASD). The biological basis of this is poorly understood but may include neurochemically mediated differences in the responsivity of key 'limbic' regions (including amygdala, ventromedial prefrontal cortex (vmPFC) and nucleus accumbens (NAc)). Emerging evidence also suggests that ASD may be a disorder of brain temporal dynamics. Moreover, serotonin (5-HT) has been shown to be a key regulator of both facial-emotion processing and brain dynamics, and 5-HT abnormalities have been consistently implicated in ASD. To date, however, no one has examined how 5-HT influences the dynamics of facial-emotion processing in ASD. Therefore, we compared the influence of 5-HT on the responsivity of brain dynamics during facial-emotion processing in individuals with and without ASD. Participants completed a facial-emotion processing fMRI task at least 8 days apart using a randomised double-blind crossover design. At each visit they received either a single 20-mg oral dose of the selective serotonin reuptake inhibitor (SSRI) citalopram or placebo. We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults. The neurotypical adults' limbic response reverted more rapidly to baseline following a 5-HT-challenge. Our results suggest that serotonergic homoeostatic control of the temporal dynamics in limbic regions is altered in adults with ASD, and provide a fresh perspective on the biology of ASD.",2020,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"['individuals with autism spectrum disorder (ASD', 'individuals with and without ASD', 'male adults with and without autism spectrum disorder (ASD', 'adults with ASD']","['serotonin (5-HT', 'citalopram', 'Serotonin', 'selective serotonin reuptake inhibitor (SSRI) citalopram or placebo', 'Emotion processing-including signals from facial expressions', '5-HT', 'placebo']",['facial-emotion processing fMRI task'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.311869,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"[{'ForeName': 'Nichol M L', 'Initials': 'NML', 'LastName': 'Wong', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. nichol.wong@kcl.ac.uk.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Findon', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vladimira', 'Initials': 'V', 'LastName': 'Stoencheva', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blainey', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ecker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Grainne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0693-0'] 129,32388622,"The effect of oxytocin, gender, and ovarian hormones on stress reactivity in individuals with cocaine use disorder.","RATIONALE Cocaine use disorder (CUD) is associated with dysregulation of the hypothalamic-pituitary-adrenal axis, which plays a critical role in the human stress response. Men and women with CUD differ in reactivity to social stressors. The hypothalamic neuropeptide oxytocin is involved in anxiolytic and natural reward processes, and has shown therapeutic potential for addictive disorders and stress reduction. OBJECTIVES To examine the impact of oxytocin (oxytocin (OXY) vs. placebo (PBO)) and gender (female (F) vs. male (M)) on response to a social stress task in individuals with CUD. To explore whether ovarian hormones moderate this stress response. METHODS One hundred twelve adults with CUD were randomized to receive 40 IU intranasal oxytocin (n = 56) or matching placebo (n = 56). Forty minutes after drug administration, participants were exposed to a social stressor. Generalized linear mixed models were used to examine neuroendocrine (cortisol) and subjective (craving, stress) response at pre-stressor, stressor + 0, + 10, + 30, + 60 min. RESULTS Gender moderated the effect of oxytocin on neuroendocrine response (p = 0.048); women receiving oxytocin (F + OXY) showed blunted cortisol response compared to the other three groups (F + PBO; M + OXY; M + PBO). There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016). Oxytocin had no significant effect on craving or stress, and gender did not moderate the effect of oxytocin on either measure. Higher endogenous progesterone was associated with lower craving response in women (p = 0.033). CONCLUSIONS Oxytocin may have differential effects in men and women with CUD. Women may be at greater risk for relapse in response to social stressors, but ovarian hormones may attenuate this effect.",2020,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"['individuals with cocaine use disorder', 'Men and women with CUD differ in reactivity to social stressors', 'One hundred twelve adults with CUD', 'individuals with CUD', 'men and women with CUD', 'gender (female (F) vs. male (M']","['oxytocin', 'oxytocin (oxytocin (OXY) vs. placebo (PBO', 'Oxytocin', '40 IU intranasal oxytocin (n\u2009=\u200956) or matching placebo']","['subjective stress response', 'blunted cortisol response', 'craving or stress', 'neuroendocrine response', 'craving response', 'neuroendocrine (cortisol) and subjective (craving, stress) response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}]",112.0,0.0816261,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Sherman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA. shermanb@musc.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Nunn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05516-w'] 130,32389532,"The Strong Hearts, Healthy Communities Program 2.0: An RCT Examining Effects on Simple 7.","INTRODUCTION Rural women have higher rates of cardiovascular disease than their nonrural counterparts, partially because of their social and environmental contexts. The study objective is to test a refined version of the multilevel Strong Hearts, Healthy Communities intervention, which used extensive process and outcome evaluation data from the original randomized trial to optimize effectiveness as measured by improved Simple 7 score, a composite measure of cardiovascular disease risk. STUDY DESIGN The intervention was implemented in a 6-month, delayed intervention, community-randomized trial; control participants received the program following 24-week outcome assessment. The study was conducted in 2017-2018; data analysis occurred in 2018-2019. SETTING/PARTICIPANTS The study was conducted in 11 rural, medically underserved towns in New York. Participants were women aged ≥40 years who were either (1) obese or (2) overweight and sedentary. INTERVENTION The intervention group received 24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments. MAIN OUTCOME MEASURES Measures included weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors. Individual Simple 7 components were examined, and mixed linear regression analyses were used to examine change in Simple 7 score. RESULTS A total of 182 participants were randomized. Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI). CONCLUSIONS These findings highlight the importance of rigorously evaluating programs in real-world community settings and, when appropriate, revising and retesting interventions to optimize dissemination potential. TRIAL REGISTRATION This study is registered at www.clinicaltrials.gov NCT03059472.",2020,"Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI). ","['2017-2018; data analysis occurred in 2018-2019', '11 rural, medically underserved towns in New York', 'Rural women', '182 participants were randomized', 'Participants were women aged ≥40 years who were either (1) obese or (2) overweight and sedentary']","['24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments']","['Simple 7 components (physical activity, healthy diet score, and BMI', 'weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",182.0,0.0779213,"Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI). ","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University System, College Station, Texas; Department of Nutrition, Texas A&M University, College Station, Texas. Electronic address: r.seguin-fowler@ag.tamu.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': 'Center for Rural Community Health, Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York.'}, {'ForeName': 'Galen D', 'Initials': 'GD', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University System, College Station, Texas.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Marshall', 'Affiliation': 'Master of Public Health Program, Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, New York.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pullyblank', 'Affiliation': 'Center for Rural Community Health, Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': 'Friedman School of Nutrition, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'Montana State University Extension, Bozeman, Montana.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.01.027'] 131,32393980,Afternoon distraction: a high-saturated-fat meal and endotoxemia impact postmeal attention in a randomized crossover trial.,"BACKGROUND Saturated-fat intake and endotoxemia can impair cognition. However, their acute impact on cognitive performance is unknown. OBJECTIVE This study assessed the impact of 2 high-fat meals and endotoxemia on attention. METHODS In this double-blind, randomized crossover trial, 51 women (n = 32 breast cancer survivors, n = 19 noncancer controls; mean ± SD age: 53 ± 8 y) completed the Continuous Performance Test (CPT) and had their blood drawn to assess endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14), and the LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal. Women again completed the CPT 5 h postmeal. At 1 to 4 wk later, women completed the same protocol but consumed the other meal. RESULTS In adjusted models, women had more difficulty distinguishing target stimuli from distractors after consuming the high-saturated-fat meal than they did after the oleic-sunflower-oil meal (B = 4.44, SE = 1.88, P = 0.02). Women with higher baseline LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04). Those with higher LBP and LBP:sCD14 were less able to sustain their attention throughout the entire CPT, as reflected by their progressively slower (B = 0.002, SE = 0.0006, P = 0.003; and B = 2.43, SE = 0.090, P = 0.008, respectively) and more erratic (B = 0.003, SE = 0.0008, P < 0.0001; and B = 3.29, SE = 1.17, P = 0.006, respectively) response times. Additionally, women with higher baseline LBP or sCD14 were less able to maintain or increase response speeds at higher interstimulus intervals (B = 0.002, SE = 0.0006, P = 0.02; and B = 0.006, SE = 0.003, P = 0.03, respectively), indicating greater difficulty adapting to changing task demands. Significant meal type by LBP and LBP:sCD14 interactions emerged (P < 0.05), such that high LBP and LBP:sCD14 erased between-meal cognitive differences, uniformly impairing performance. CONCLUSIONS These results suggest that higher LBP, sCD14, and LBP:sCD14 and saturated-fat intake individually and jointly influence attention. Endotoxemia may override the relative cognitive benefit of healthier oil choices.This trial is registered at clinicaltrials.gov as NCT04247763.",2020,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","['Women with higher baseline', '51 women (n\xa0=\xa032 breast cancer survivors, n\xa0=\xa019 noncancer controls; mean ± SD age: 53 ± 8 y']","['Afternoon distraction', 'LBP', 'Continuous Performance Test (CPT', 'LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal']","['endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14', 'cognitive performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}]",51.0,0.151899,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","[{'ForeName': 'Annelise A', 'Initials': 'AA', 'LastName': 'Madison', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Belury', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andridge', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'M Rosie', 'Initials': 'MR', 'LastName': 'Shrout', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Renna', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Malarkey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Bailey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Janice K', 'Initials': 'JK', 'LastName': 'Kiecolt-Glaser', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa085'] 132,32398738,"Impact of different cord clamping strategies on short term neuromonitoring among preterm infants: a randomized, controlled trial.",,2020,,['preterm infants'],['cord clamping strategies'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]",[],,0.201929,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA. pagarwal@dmc.org.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': ""Children's Research Center of Michigan, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0684-3'] 133,32399853,"Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses.","BACKGROUND AND OBJECTIVE SUVN-G3031 is a novel, potent, and selective histamine-3 receptor (H 3 R) inverse agonist in development for the treatment of narcolepsy. Our objective was to characterize the safety, tolerability, and pharmacokinetics of SUVN-G3031 in healthy young adults after single and multiple doses, and to evaluate the effect of food, gender, and age on the pharmacokinetics. METHODS A single ascending dose (SAD) and a multiple ascending dose (MAD) study for 14 days was conducted in healthy young adults using a randomized, double-blind study design. The effect of food, gender, and age on SUVN-G3031 pharmacokinetics (6 mg as a single dose) was evaluated using an open-label, two-period, randomized, crossover design in fed and fasted states. Pharmacokinetics and safety assessments were conducted throughout the study. RESULTS Single doses of SUVN-G3031 up to 20 mg and multiple doses up to 6 mg once daily were found to be safe and well tolerated in healthy young adults. The most frequently reported adverse events were abnormal dreams, dyssomnia, and hot flushes. SUVN-G3031 exposure was dose proportional across the tested doses. Steady state was achieved on day 6 after once-daily dosing. Renal excretion (~ 60%) of unchanged SUVN-G3031 was the major route of elimination. Food, gender, and age did not have any clinically meaningful effect on SUVN-G3031 exposure. CONCLUSION SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile. Clinical Trials Registration (https://clinicaltrials.gov): NCT04072380 and NCT02342041.",2020,"SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile.","['Healthy Human Subjects Following Single and Multiple Oral Doses', 'healthy human subjects', 'healthy young adults']",[],"['Renal excretion', 'safety, tolerability, and pharmacokinetics', 'Safety, Tolerability, and Pharmacokinetics', 'safe and well tolerated']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0520693,"SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile.","[{'ForeName': 'Ramakrishna', 'Initials': 'R', 'LastName': 'Nirogi', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India. nvsrk@suven.com.'}, {'ForeName': 'Koteshwara', 'Initials': 'K', 'LastName': 'Mudigonda', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Gopinadh', 'Initials': 'G', 'LastName': 'Bhyrapuneni', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Nageswara Rao', 'Initials': 'NR', 'LastName': 'Muddana', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shinde', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Goyal', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Santosh Kumar', 'Initials': 'SK', 'LastName': 'Pandey', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Abdul Rasheed', 'Initials': 'AR', 'LastName': 'Mohammed', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Jyothsna', 'Initials': 'J', 'LastName': 'Ravula', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Jetta', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Veera Raghava Chowdary', 'Initials': 'VRC', 'LastName': 'Palacharla', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}]",Clinical drug investigation,['10.1007/s40261-020-00920-8'] 134,32334635,Preoperative assessment of lymph node metastasis in Colon Cancer patients using machine learning: a pilot study.,"BACKGROUND Preoperative detection of lymph node (LN) metastasis is critical for planning treatments in colon cancer (CC). The clinical diagnostic criteria based on the size of the LNs are not sensitive to determine metastasis using CT images. In this retrospective study, we investigated the potential value of CT texture features to diagnose LN metastasis using preoperative CT data and patient characteristics by developing quantitative prediction models. METHODS A total of 390 CC patients, undergone surgical resection, were enrolled in this monocentric study. 390 histologically validated LNs were collected from patients and randomly separated into training (312 patients, 155 metastatic and 157 normal LNs) and test cohorts (78 patients, 39 metastatic and 39 normal LNs). Six patient characteristics and 146 quantitative CT imaging features were analyzed and key variables were determined using either exhaustive search or least absolute shrinkage algorithm. Two kernel-based support vector machine classifiers (patient-characteristic model and radiomic-derived model), generated with 10-fold cross-validation, were compared with the clinical model that utilizes long-axis diameter for diagnosis of metastatic LN. The performance of the models was evaluated on the test cohort by computing accuracy, sensitivity, specificity, and area under the receiver operating curve (AUC). RESULTS The clinical model had an overall diagnostic accuracy of 64.87%; specifically, accuracy of 65.38% and 62.82%, sensitivity of 83.87% and 84.62%, and specificity of 47.13% and 41.03% for training and test cohorts, respectively. The patient-demographic model obtained accuracy of 67.31% and 73.08%, the sensitivity of 62.58% and 69.23%, and specificity of 71.97% and 76.23% for training and test cohorts, respectively. Besides, the radiomic-derived model resulted in an accuracy of 81.09% and 79.49%, sensitivity of 83.87% and 74.36%, and specificity of 78.34% and 84.62% for training and test cohorts, respectively. Furthermore, the diagnostic performance of the radiomic-derived model was significantly higher than clinical and patient-demographic models (p < 0.02) according to the DeLong method. CONCLUSIONS The texture of the LNs provided characteristic information about the histological status of the LNs. The radiomic-derived model leveraging LN texture provides better preoperative diagnostic accuracy for the detection of metastatic LNs compared to the clinically accepted diagnostic criteria and patient-demographic model.",2020,The radiomic-derived model leveraging LN texture provides better preoperative diagnostic accuracy for the detection of metastatic LNs compared to the clinically accepted diagnostic criteria and patient-demographic model.,"['Colon Cancer patients using', '390 CC patients, undergone surgical resection', '390 histologically validated LNs were collected from patients and randomly separated into training (312 patients, 155 metastatic and 157 normal LNs) and test cohorts (78 patients, 39 metastatic and 39 normal LNs']","['Two kernel-based support vector machine classifiers', 'machine learning']","['accuracy, sensitivity, specificity, and area under the receiver operating curve (AUC', 'overall diagnostic accuracy']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",390.0,0.025777,The radiomic-derived model leveraging LN texture provides better preoperative diagnostic accuracy for the detection of metastatic LNs compared to the clinically accepted diagnostic criteria and patient-demographic model.,"[{'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Eresen', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Shangguan', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yury', 'Initials': 'Y', 'LastName': 'Velichko', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Yaghmai', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University, 675 N. St. Clair, 21st Floor, Chicago, IL, 60611, USA. albenson@nm.org.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA. zhuoli-zhang@northwestern.edu.'}]",Cancer imaging : the official publication of the International Cancer Imaging Society,['10.1186/s40644-020-00308-z'] 135,32336148,Composite active range of motion (CX A ) and relationship with active function in upper and lower limb spastic paresis.,"OBJECTIVE The aim of this study is to evaluate a novel composite measure of active range of motion (X A ) and determine whether this measure correlates with active function. DESIGN Post hoc analysis of two randomized, placebo-controlled, double-blind studies with open-label extensions exploring changes in active function with abobotulinumtoxinA. SETTING Tertiary rehabilitation centers in Australia, Europe, and the United States. SUBJECTS Adults with upper ( n  = 254) or lower ( n  = 345) limb spastic paresis following stroke or brain trauma. INTERVENTIONS AbobotulinumtoxinA (⩽5 treatment cycles) in the upper or lower limb. MAIN MEASURES X A was used to calculate a novel composite measure (CX A ), defined as the sum of X A against elbow, wrist, and extrinsic finger flexors (upper limb) or soleus and gastrocnemius muscles (lower limb). Active function was assessed by the Modified Frenchay Scale and 10-m comfortable barefoot walking speed in the upper limb and lower limb, respectively. Correlations between CX A and active function at Weeks 4 and 12 of open-label cycles were explored. RESULTS CX A and active function were moderately correlated in the upper limb ( P  < 0.0001-0.0004, r  = 0.476-0.636) and weakly correlated in the lower limb ( P  < 0.0001-0.0284, r  = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle. Changes in CX A and active function were weakly correlated only in the upper limb (Cycle 2 Week 12, P  = 0.0160, r  = 0.213; Cycle 3 Week 4, P  = 0.0031, r  = 0.296). Across cycles, CX A improvements peaked at Week 4, while functional improvements peaked at Week 12. CONCLUSION CX A is a valid measure for functional impairments in spastic paresis. CX A improvements following abobotulinumtoxinA injection correlated with and preceded active functional improvements.",2020,"A and active function were moderately correlated in the upper limb ( P  < 0.0001-0.0004, r  = 0.476-0.636) and weakly correlated in the lower limb ( P  < 0.0001-0.0284, r  = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle.","['upper and lower limb spastic paresis', 'Adults with upper ( n \u2009=\u2009254) or lower ( n \u2009=\u2009345) limb spastic paresis following stroke or brain trauma', 'spastic paresis', 'Tertiary rehabilitation centers in Australia, Europe, and the United States']","['abobotulinumtoxinA injection', 'CX', 'AbobotulinumtoxinA', 'Composite active range of motion (CX A ', 'placebo']","['Active function', 'active functional improvements', 'active function']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0747265', 'cui_str': 'Spastic paresis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0630058,"A and active function were moderately correlated in the upper limb ( P  < 0.0001-0.0004, r  = 0.476-0.636) and weakly correlated in the lower limb ( P  < 0.0001-0.0284, r  = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bayle', 'Affiliation': 'EA 7377 BIOTN, Service de Rééducation Neurolocomotrice, Université Paris-Est Créteil, Hospital Albert Chenevier-Henri Mondor, Créteil, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Maisonobe', 'Affiliation': 'Biometry, Ipsen Pharma, Boulogne-Billancourt, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Raymond', 'Affiliation': 'Biostatistics, Ividata, Levallois-Perret, France.'}, {'ForeName': 'Jovita', 'Initials': 'J', 'LastName': 'Balcaitiene', 'Affiliation': 'Global Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gracies', 'Affiliation': 'EA 7377 BIOTN, Service de Rééducation Neurolocomotrice, Université Paris-Est Créteil, Hospital Albert Chenevier-Henri Mondor, Créteil, France.'}]",Clinical rehabilitation,['10.1177/0269215520911970'] 136,32315769,"Commentary on ""Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study"".",,2020,,[],['Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery'],[],[],"[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.158978,,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'von Bechtolsheim', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany. Electronic address: felix.bechtolsheim@uniklinikum-dresden.de.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.086'] 137,32315954,"Screening for oral cancer: Future prospects, research and policy development for Asia.","Although the incidence of oral cavity cancer is high among low and middle income countries in Asia where the risk habits (tobacco smoking, tobacco chewing and betel quid use) are common, the benefits for introducing oral cancer screening for the whole population in these countries still remains controversial. It is disappointing, but not surprising that many of studies, without control arms, could not provide a clear answer as to whether screening is effective in reducing mortality or combating rising incidence trends. Only one Indian study that reported a randomized controlled trial (RCT) elucidated that mass screening for high risk groups could significantly reduce the cancer mortality or down-stage cancers detected by screening. Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer. In this review we discuss advantages and disadvantages for oral cancer screening particularly with reference to high incidence countries in Asia. If screening is undertaken, we propose that it is targeted to high risk groups and to combine screening with education on risky life-styles so that overall incidence can be reduced in the future. Further research on increasing public awarenes and impact of professional education such as e-learning to reduce diagnostic delays, studies on the natural history of oral potentially malignant disorders and cancer, comprehensive tobacco and areca nut cessation programs, developing tools to identify high-risk individuals and high-risk lesions are proposed.",2020,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.",['oral cancer'],[],['cancer mortality'],"[{'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}]",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0484795,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Maxillofacial Surgery School of Dentistry, Aichi Gakuin University, Nagoya, Japan. Electronic address: tnagao@dpc.agu.ac.jp.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Warnakulasuriya', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, WHO Collaborating Centre for Oral Cancer, UK.""}]",Oral oncology,['10.1016/j.oraloncology.2020.104632'] 138,32208176,The effects of short-term moderate intensity aerobic exercise and long-term detraining on electrocardiogram indices and cardiac biomarkers in postmenopausal women.,"OBJECTIVE The purpose of this study was to investigate the effects of 12-week of moderate-intensity aerobic exercise and 5-month detraining on electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P) in postmenopausal women (PMWs). MATERIALS AND METHODS Thirty-one PMWs (aged 50-70 yrs) were randomized to exercise (EX, n = 16) and control (C, n = 15) groups. EX group performed of 12-week of warm up- walking/jogging moderate intensity aerobic exercise training program- recovery (60 min/day, 3 days/week at 70% of maximal heart rate reserve), and then 5-month detraining remained. C group maintain their normal lifestyle during 8 months. The ECG indices and cardiac serum levels were measured at baseline, after 12-week exercise, and after 5-month detraining. RESULTS After 12-week exercise intervention, P-R interval, serum PTH and serum Vit D were significantly increased in the EX group compared to the C group (P = 0.020, P = 0.001 and P = 0.001, respectively). After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group. CONCLUSIONS The results suggested that 12-week of moderate intensity aerobic exercise increased the P-R interval, PTH and Vit D, as severe Vit D deficiency status (below 10 ng/ml) improved to Vit D deficiency status (between 10 and 20 ng/ml) in PMWs. Also, long-term positive adaptations to aerobic exercise such as increased Vit D were observed even after 5-month detraining. In addition, P-R segment and S-T interval decreased after 5-month detraining in sedentary PMWs, which may be a sign of atrial positive adaptations to aerobic exercise.",2020,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group. ","['postmenopausal women (PMWs', 'postmenopausal women', 'Thirty-one PMWs (aged 50-70\xa0yrs']","['warm up- walking/jogging moderate intensity aerobic exercise training program- recovery', 'exercise (EX', 'short-term moderate intensity aerobic exercise and long-term detraining', 'moderate-intensity aerobic exercise and 5-month detraining', 'moderate intensity aerobic exercise']","['Vit D', 'electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P', 'ECG indices and cardiac serum levels', 'electrocardiogram indices and cardiac biomarkers', 'P-R interval, serum PTH and serum Vit D', 'serum Vit D', 'Vit D deficiency status', 'P-R segment and S-T interval', 'P-R interval, PTH and Vit D, as severe Vit D deficiency status']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0596235', 'cui_str': 'Ca 2+'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0520879', 'cui_str': 'P-R segment, function (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0251744,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group. ","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Exercise Physiology, Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Fellowship of Balloon Angioplasty, Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Clinical Biochemistry, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.004'] 139,32232363,Acute Effects of Glucagon on Reproductive Hormone Secretion in Healthy Men.,"CONTEXT Glucagon increases energy expenditure; consequently, glucagon receptor agonists are in development for the treatment of obesity. Obesity negatively affects the reproductive axis, and hypogonadism itself can exacerbate weight gain. Therefore, knowledge of the effects of glucagon receptor agonism on reproductive hormones is important for developing therapeutics for obesity; but reports in the literature about the effects of glucagon receptor agonism on the reproductive axis are conflicting. OBJECTIVE The objective of this work is to investigate the effect of glucagon administration on reproductive hormone secretion in healthy young men. DESIGN A single-blinded, randomized, placebo-controlled crossover study was conducted. SETTING The setting of this study was the Clinical Research Facility, Imperial College Healthcare NHS Trust. PARTICIPANTS Eighteen healthy eugonadal men (mean ± SEM: age 25.1 ± 1.0 years; body mass index 22.5 ± 0.4 kg/m2; testosterone 21.2 ± 1.2 nmol/L) participated in this study. INTERVENTION An 8-hour intravenous infusion of 2 pmol/kg/min glucagon or rate-matched vehicle infusion was administered. MAIN OUTCOME MEASURES Luteinizing hormone (LH) pulsatility; LH, follicle-stimulating hormone (FSH), and testosterone levels were measured. RESULTS Although glucagon administration induced metabolic effects (insulin area under the curve: vehicle 1065 ± 292 min.µU/mL vs glucagon 2098 ± 358 min.µU/mL, P < .001), it did not affect LH pulsatility (number of LH pulses/500 min: vehicle 4.7 ± 0.4, glucagon 4.2 ± 0.4, P = .22). Additionally, there were no significant differences in circulating LH, FSH, or testosterone levels during glucagon administration compared with vehicle administration. CONCLUSIONS Acute administration of a metabolically active dose of glucagon does not alter reproductive hormone secretion in healthy men. These data are important for the continued development of glucagon-based treatments for obesity.",2020,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","['Healthy Men', 'Eighteen healthy eugonadal men (mean±SEM', 'healthy men', 'healthy young men']","['placebo', 'glucagon receptor agonism', 'glucagon administration', '2pmol/kg/min glucagon or rate-matched vehicle infusion', 'Glucagon', 'glucagon']","['circulating LH, FSH or testosterone levels', 'LH pulsatility', 'Reproductive Hormone Secretion', 'metabolic effects', 'reproductive hormone secretion', 'Luteinizing hormone (LH) pulsatility; LH, follicle stimulating hormone (FSH) and testosterone levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility (attribute)'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}]",18.0,0.287042,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Izzi-Engbeaya', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Yoshibye', 'Initials': 'Y', 'LastName': 'Crustna', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pratibha C', 'Initials': 'PC', 'LastName': 'Machenahalli', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Starikova', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pei Chia', 'Initials': 'PC', 'LastName': 'Eng', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Risheka', 'Initials': 'R', 'LastName': 'Ratnasabapathy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Pacuszka', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Minnion', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tharakan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Veldhuis', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa164'] 140,31021691,Immediate and Short-term Effects of Thoracic Spine Manipulation in Patients With Cervical Radiculopathy: A Randomized Controlled Trial.,"BACKGROUND Thoracic spine thrust manipulation has been shown to improve patient-rated outcomes for individuals with neck pain. However, there is limited evidence of its effectiveness in patients with cervical radiculopathy. OBJECTIVES To compare the immediate and short-term effects of thoracic manipulation to those of a sham thoracic manipulation in patients with cervical radiculopathy. METHODS In this multicenter randomized controlled trial, participants with cervical radiculopathy were randomized to receive either manipulation (n = 22) or sham manipulation (n = 21) of the thoracic spine. Outcomes were measured at baseline, immediately after treatment, and at a follow-up 48 to 72 hours after manipulation. A repeated-measures analysis of variance was used to analyze neck and upper extremity pain (numeric pain-rating scale), disability (Neck Disability Index), cervical range of motion (ROM), and endurance (deep neck flexor endurance test). The chi-square test was used to analyze changes in neck and upper extremity pain, centralization of symptoms, and beliefs about receiving the active manipulation treatment using a global rating of change scale. RESULTS Neck and upper extremity pain, cervical ROM, disability, and deep neck flexor endurance all showed significant interactions between group and time ( P <.01). Immediately after treatment and at the 48-to-72-hour follow-up, the manipulation group had lower neck pain ( P <.01), better cervical ROM ( P <.01), lower disability ( P <.01), and better deep neck flexor endurance ( P = .02) compared to the sham manipulation group. The manipulation group had moderate to large effect-size changes over time. No between-group differences for upper extremity pain were found immediately following the intervention ( P = .34) and at 48 to 72 hours after the intervention ( P = .18). At 48 to 72 hours after treatment, a greater proportion of participants in the manipulation group reported improvement (global rating of change scale score of 4 or greater) in neck and upper extremity symptoms ( P <.01), centralization of symptoms ( P <.01), and beliefs about receiving an active manipulation ( P = .01) compared to the sham manipulation group. CONCLUSION One session of thoracic manipulation resulted in improvements in pain, disability, cervical ROM, and deep neck flexor endurance in patients with cervical radiculopathy. Patients treated with manipulation were more likely to report at least moderate change in their neck and upper extremity symptoms up to 48 to 72 hours following treatment. LEVEL OF EVIDENCE Therapy, level 2. J Orthop Sports Phys Ther 2019;49(5):299-309. doi:10.2519/jospt.2019.8150 .",2019,"One session of thoracic manipulation resulted in improvements in pain, disability, cervical ROM, and deep neck flexor endurance in patients with cervical radiculopathy.","['individuals with neck pain', 'participants with cervical radiculopathy', 'Patients With Cervical Radiculopathy', 'patients with cervical radiculopathy']","['sham manipulation', 'Thoracic Spine Manipulation', 'thoracic manipulation', 'sham thoracic manipulation', 'J Orthop Sports']","['neck and upper extremity pain (numeric pain-rating scale), disability (Neck Disability Index), cervical range of motion (ROM), and endurance (deep neck flexor endurance test', 'lower disability', 'lower neck pain', 'centralization of symptoms', 'Neck and upper extremity pain, cervical ROM, disability, and deep neck flexor endurance', 'changes in neck and upper extremity pain, centralization of symptoms, and beliefs', 'cervical ROM', 'neck and upper extremity symptoms', 'deep neck flexor endurance', 'improvement (global rating of change scale score of 4 or greater) in neck and upper extremity symptoms', 'beliefs about receiving an active manipulation', 'pain, disability, cervical ROM, and deep neck flexor endurance', 'upper extremity pain']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure (body structure)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}]","[{'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0203917', 'cui_str': 'Active manipulation'}]",,0.142904,"One session of thoracic manipulation resulted in improvements in pain, disability, cervical ROM, and deep neck flexor endurance in patients with cervical radiculopathy.","[{'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pozzi', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Linkonis', 'Affiliation': ''}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Michener', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8150'] 141,31400517,Clinical exome sequencing vs. usual care for hereditary colorectal cancer diagnosis: A pilot comparative effectiveness study.,"BACKGROUND Clinical exome sequencing (CES) provides the advantage of assessing genetic variation across the human exome compared to a traditional stepwise diagnostic approach or multi-gene panels. Comparative effectiveness research methods offer an approach to better understand the patient-centered and economic outcomes of CES. PURPOSE To evaluate CES compared to usual care (UC) in the diagnostic work-up of inherited colorectal cancer/polyposis (CRCP) in a randomized controlled trial (RCT). METHODS The primary outcome was clinical sensitivity for the diagnosis of inherited CRCP; secondary outcomes included psychosocial outcomes, family communication, and healthcare resource utilization. Participants were surveyed 2 and 4 weeks after results return and at 3-month intervals up to 1 year. RESULTS Evolving outcome measures and standard of care presented critical challenges. The majority of participants in the UC arm received multi-gene panels [94.73%]. Rates of genetic findings supporting the diagnosis of hereditary CRCP were 7.5% [7/93] vs. 5.4% [5/93] in the CES and UC arms, respectively (P = 0.28). Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms. More participants with positive results (17.7%) intended to change their life insurance 1  month after the first return visit compared to participants returned a variant of uncertain significance (9.1%) or negative result (4.8%) (P = 0.09). CONCLUSION Our results suggest that CES provides similar clinical benefits to multi-gene panels in the diagnosis of hereditary CRCP.",2019,"Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms.",['hereditary colorectal cancer diagnosis'],"['CES', 'usual care (UC']","['healthcare resource utilization, family communication and psychosocial outcomes', 'privacy concerns', 'clinical sensitivity for the diagnosis of inherited CRCP; secondary outcomes included psychosocial outcomes, family communication, and healthcare resource utilization']","[{'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],"[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",,0.0971893,"Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Amendola', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Ragan', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Bennette', 'Affiliation': 'Flatiron Health, New York, NY 10010, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Horike-Pyne', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Trinidad', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Nefcy', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Fuki M', 'Initials': 'FM', 'LastName': 'Hisama', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bennett', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Grady', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98101, USA.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Gallego', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA; Department of Genetics and Genome Sciences, Case Western Reserve University, Cleveland, OH 44106, USA; Comparative Health Outcomes, Economics and Policy Institute (CHOICE), University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tarczy-Hornoch', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Wylie', 'Initials': 'W', 'LastName': 'Burke', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Regier', 'Affiliation': 'Canadian Centre for Applied Research in Cancer Control, BC Cancer Agency, Vancouver, BC V5Z 1L3, Canada.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Dorschner', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, WA 98195, USA; Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Shirts', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Peggy D', 'Initials': 'PD', 'LastName': 'Robertson', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Nickerson', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Patrick', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA; Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Veenstra', 'Affiliation': 'Comparative Health Outcomes, Economics and Policy Institute (CHOICE), University of Washington, Seattle, WA 98195, USA. Electronic address: veenstra@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105820'] 142,32398420,Omalizumab and other biologics in drug desensitization.,"PURPOSE OF REVIEW Omalizumab has been proposed for controlling adverse reactions during drug desensitization. Our aim is to know the current evidence involving the use of omalizumab in drug-allergy desensitization. RECENT FINDINGS Drug-allergy desensitization is not risk free, but it is a useful procedure and has been applied for drug hypersensitivity reactions with mast cells degranulation through IgE and non-IgE mechanisms. Since 2007, omalizumab has been considered as a potential strategy to prevent adverse reactions.Our review found few case reports and only one randomized double-blind, placebo-controlled study, using different omalizumab regimens prior to drug desensitization. This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies. SUMMARY Omalizumab or other IgE-targeting biologics, either a fixed dose of 300 mg omalizumab or a dose-related total IgE level and body mass weight may be an option for patients with IgE-mediated or mast cell drug reactions in troublesome desensitization.",2020,"This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies. ",[],"['omalizumab', 'Omalizumab', 'placebo']",[],[],"[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.217773,"This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies. ","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fernandez', 'Affiliation': 'Allergy Section, Alicante General University Hospital, ISABIAL-UMH.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ruano-Zaragoza', 'Affiliation': 'Allergy Section, Alicante General University Hospital, Alicante.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Blanca-Lopez', 'Affiliation': 'Allergy Service, Infanta Leonor University Hospital.'}]",Current opinion in allergy and clinical immunology,['10.1097/ACI.0000000000000648'] 143,32305650,"The impact of an educational video about radiotherapy and its toxicities in head and neck cancer patients. Evaluation of patients' understanding, anxiety, depression, and quality of life.","OBJECTIVES Head and neck radiotherapy can cause several toxicities, and its management has important treatment implications. Proper information about treatment is crucial to assist patients by preparing them and enhancing their ability to manage their illness. Thus, this study aimed to verify the impact of an educational video on the improvement of the patient's understanding, satisfaction, quality of life, and influence on their emotional state in different moments of treatment. METHODS A 10 min video about head and neck radiotherapy and its toxicities was produced. A prospective randomized clinical trial was performed in two groups: a control group (n = 65), which received standard verbal and written information, and an experimental group (n = 65), which received standard information and the video. Appropriated questionnaires (HADS, UW-QOLv4, IRTU, and Post-RTU) were applied in four different moments in order to evaluate patients' understanding, anxiety, depression, and quality of life. RESULTS The video improved the understanding of treatment and its side effects. Also, the video group reported better awareness about oral health care during the treatment. Osteoradionecrosis and radiation-related caries were the most unknown side effects. On the other hand, the educational video did not modify the patients' anxiety, depression, and quality of life. All patients reported high satisfaction with the video. CONCLUSIONS Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers. In addition, information about osteoradionecrosis and radiation-related caries must be reinforced to patients.",2020,"CONCLUSIONS Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers.",['head and neck cancer patients'],"['standard verbal and written information, and an experimental group (n\xa0=\xa065), which received standard information and the video', 'educational video about radiotherapy', 'educational video']","['anxiety, depression, and quality of life', 'Appropriated questionnaires (HADS, UW-QOLv4, IRTU, and Post-RTU', 'awareness about oral health care', ""patients' anxiety, depression, and quality of life""]","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0257791,"CONCLUSIONS Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers.","[{'ForeName': 'Diego Tetzner', 'Initials': 'DT', 'LastName': 'Fernandes', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Prado-Ribeiro', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil; Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Renata Lucena', 'Initials': 'RL', 'LastName': 'Markman', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Morais', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil; Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Moutinho', 'Affiliation': 'Department of Radiology and Oncology, Faculdade de Medicina, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Juliana Ono', 'Initials': 'JO', 'LastName': 'Tonaki', 'Affiliation': 'Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Thaís Bianca', 'Initials': 'TB', 'LastName': 'Brandão', 'Affiliation': 'Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Oral Pathology and Medicine Research Group, Department of Basic Biomedical Sciences, Faculty of Health Sciences, Universidad de Talca, Chile.'}, {'ForeName': 'Alan Roger', 'Initials': 'AR', 'LastName': 'Santos-Silva', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Márcio Ajudarte', 'Initials': 'MA', 'LastName': 'Lopes', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil. Electronic address: malopes@fop.unicamp.br.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104712'] 144,32199333,Effect of pre-term birth on oxidative stress responses to normoxic and hypoxic exercise.,"Pre-term birth is a major health concern that occurs in approximately 10% of births worldwide. Despite high incidence rate, long-term consequences of pre-term birth remain unclear. Recent evidence suggests that elevated oxidative stress observed in pre-term born infants could persist into adulthood. Given that oxidative stress is known to play an important role in response to physical activity and hypoxia, we investigated whether oxidative stress responses to acute exercise in normoxia and hypoxia may be differently modulated in pre-term vs. full-term born adults. Twenty-two pre-term born and fifteen age-matched full-term born controls performed maximal incremental cycling tests in both normoxia (FiO2: 0.21) and normobaric hypoxia (FiO2: 0.13; simulated altitude of 3800 m) in blinded and randomized manner. Plasma levels of oxidative stress (advanced oxidation protein products [AOPP] and malondialdehyde), antioxidant (ferric reducing antioxidant power, glutathione peroxidase, catalase [CAT] and superoxide dismutase [SOD]) and nitrosative stress markers (nitrotyrosine, nitrite and total nitrite and nitrate [NOx]) were measured before and immediately after each test. AOPP (+24%, P<0.001), CAT (+38%, P<0.001) and SOD (+12%, P=0.018) and NOx (+17%, P=0.024) significantly increased in response to exercise independently of condition and birth status. No difference in response to acute exercise in normoxia was noted between pre-term and full-term born adults in any of measured markers. Hypoxic exposure during exercise resulted in significant increase in AOPP (+45%, P=0.008), CAT (+55%, P=0.019) and a trend for an increase in nitrite/nitrate content (+35%, P=0.107) only in full-term and not pre-term born individuals. These results suggest that prematurely born adult individuals exhibit higher resistance to oxidative stress response to exercise in hypoxia.",2020,"Hypoxic exposure during exercise resulted in significant increase in AOPP (+45%, P=0.008), CAT (+55%, P=0.019) and a trend for an increase in nitrite/nitrate content (+35%, P=0.107) only in full-term and not pre-term born individuals.",['Twenty-two pre-term born and fifteen age-matched full-term born controls performed'],"['maximal incremental cycling tests in both normoxia (FiO2: 0.21) and normobaric hypoxia (FiO2', 'normoxic and hypoxic exercise']","['ferric reducing antioxidant power, glutathione peroxidase, catalase [CAT] and superoxide dismutase [SOD]) and nitrosative stress markers (nitrotyrosine, nitrite and total nitrite and nitrate [NOx', 'elevated oxidative stress', 'Plasma levels of oxidative stress (advanced oxidation protein products [AOPP] and malondialdehyde), antioxidant ', 'NOx ', 'response to acute exercise in normoxia', 'CAT', 'nitrite/nitrate content', 'SOD', 'AOPP']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C4517437', 'cui_str': '0.21 (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C4505047', 'cui_str': 'Nitrosative Stress'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.074492,"Hypoxic exposure during exercise resulted in significant increase in AOPP (+45%, P=0.008), CAT (+55%, P=0.019) and a trend for an increase in nitrite/nitrate content (+35%, P=0.107) only in full-term and not pre-term born individuals.","[{'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': ""Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Univ Lyon, Université Jean Monet Saint-Etienne, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine, Campus Santé Innovation, 10 rue de la Marandière10 rue de la Marandière, Saint-Priest-en-Jarez, France; Univ Lyon, Université Claude Bernard Lyon 1, Master BioSciences, Department of Biology, École Normale Supérieure of Lyon, 46 allée d'Italie, 69364 LYON CEDEX 07, Lyon, France. Electronic address: agnes.martin@ens-lyon.org.""}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Millet', 'Affiliation': 'ISSUL, Institute of Sport Sciences, Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland. Electronic address: gregoire.millet@unil.ch.'}, {'ForeName': 'Damjan', 'Initials': 'D', 'LastName': 'Osredkar', 'Affiliation': ""Department of Pediatric Neurology, University Children's Hospital Ljubljana, Ljubljana, Slovenia. Electronic address: damjan.osredkar@kclj.si.""}, {'ForeName': 'Minca', 'Initials': 'M', 'LastName': 'Mramor', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia. Electronic address: minca.mramor@ukclj.si.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faes', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Laboratory of Excellence GR-Ex, Paris, France. Electronic address: camille.faes@univ-lyon1.fr.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Gouraud', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Laboratory of Excellence GR-Ex, Paris, France. Electronic address: etienne.gouraud@univ-lyon1.fr.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Debevec', 'Affiliation': ""Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia; Department of Pediatric Emergency, University Children's Hospital Ljubljana, Ljubljana, Slovenia; Department of Automation, Biocybernetics and Robotics, Jozef Stefan Institute, Ljubljana, Slovenia. Electronic address: tadej.debevec@fsp.uni-lj.si.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pialoux', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Laboratory of Excellence GR-Ex, Paris, France; Institut Universitaire de France, France. Electronic address: vincent.pialoux@univ-lyon1.fr.'}]",Redox biology,['10.1016/j.redox.2020.101497'] 145,32234531,Which strategies to manage problem foods were related to weight loss in a randomized clinical trial?,"Individuals managing their weight are often faced with problem foods that are difficult to resist eating. In the context of a weight-loss intervention, we characterized the most commonly reported problem foods and the behavioral strategies used to manage them, and examined which strategies were related to weight loss. Women with overweight and obesity (N = 186) participated in a one-year randomized trial of three interventions (NCT01474759): standard advice to eat less food, choosing portions based on energy density, and using pre-portioned foods. At Months 0, 6, and 12 of the trial, participants listed the foods they found most problematic and reported the frequency of using eight behavioral strategies to control intake of these foods, including three practices for avoiding exposure to problem foods and three for consuming them but limiting intake. The responses showed that 82% of the top three problem foods were in the categories of sweet baked items, salty snacks, starchy side dishes, chocolate and candy, and ice cream. After one year, women who reported more frequently using the strategy of limiting portions of problem foods had a greater rate of weight loss (kg/week), regardless of their intervention group (p < 0.0001). Among women who limited portions of problem foods less frequently, those using pre-portioned foods had greater initial weight loss compared to the other two groups, but then regained weight at a greater rate (p < 0.0001). The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss. These results suggest that adopting and maintaining strategies to manage portions of problem foods, rather than avoiding exposure to them, can be a more useful approach for weight loss.",2020,The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss.,['Women with overweight and obesity'],"['standard advice to eat less food, choosing portions based on energy density, and using pre-portioned foods']","['rate of weight loss', 'categories of sweet baked items, salty snacks, starchy side dishes, chocolate and candy, and ice cream', 'initial weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0020747', 'cui_str': 'Ice cream'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",186.0,0.0213008,The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss.,"[{'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Roe', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA. Electronic address: LSR7@psu.edu.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",Appetite,['10.1016/j.appet.2020.104687'] 146,32325038,"Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.","BACKGROUND Cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection continue to rise in the Arabian Peninsula 7 years after it was first described in Saudi Arabia. MERS-CoV poses a significant risk to public health security because of an absence of currently available effective countermeasures. We aimed to assess the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans. METHODS This dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial was done at the Centre for Clinical Vaccinology and Tropical Medicine (Oxford, UK) and included healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women). Participants received a single intramuscular injection of ChAdOx1 MERS at three different doses: the low-dose group received 5 × 10 9 viral particles, the intermediate-dose group received 2·5 × 10 10 viral particles, and the high-dose group received 5 × 10 10 viral particles. The primary objective was to assess safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited, unsolicited, and serious adverse events after vaccination. The secondary objective was to assess the cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays after vaccination. Participants were followed up for up to 12 months. This study is registered with ClinicalTrials.gov, NCT03399578. FINDINGS Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at 6 months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 10 10 viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed to be not related to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered to be possibly, probably, or definitely related to ChAdOx1 MERS were predominantly mild in nature and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001) Laboratory adverse events considered to be at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. INTERPRETATION ChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to elicit both humoral and cellular responses against MERS-CoV. The results of this first-in-human clinical trial support clinical development progression into field phase 1b and 2 trials. FUNDING UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.",2020,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. ","['healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women', '24 participants were enrolled: six', 'Between March 14 and Aug 15, 2018', 'humans']","['single intramuscular injection of ChAdOx1 MERS', 'low-dose group received 5\u2008×\u200810 9 viral particles, the intermediate-dose group received 2·5\u2008×\u200810 10 viral particles, and the high-dose group received 5\u2008×\u200810 10 viral particles', 'candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine', 'ChAdOx1 MERS']","['Unsolicited adverse events', 'cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays', 'Safety and immunogenicity', 'safety and tolerability of ChAdOx1 MERS', 'serious adverse events', 'safe and well tolerated', 'safety and immunogenicity', 'Neutralising antibodies against live MERS-CoV', 'T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen', 'occurrence of solicited, unsolicited, and serious adverse events', 'proportion of moderate and severe adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019683', 'cui_str': 'Human immunodeficiency virus antibody'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",24.0,0.0881364,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. ","[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Ramos', 'Initials': 'FR', 'LastName': 'Lopez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mair', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheridan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Young-Shin', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Jae-Ouk', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Manki', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Datoo', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30160-2'] 147,32139250,Letter to the Editor: Effect of fatty fish or nut consumption on concentrations of persistent organic pollutants in overweight or obese men and women: A randomized controlled clinical trial.,,2020,,['overweight or obese men and women'],['fatty fish or nut consumption'],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",[],,0.124,,"[{'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Duk-Hee', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea; BK21 Plus KNU Biomedical Convergence Program, Department of Biomedical Science, Kyungpook National University, Republic of Korea. Electronic address: lee_dh@knu.ac.kr.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.01.015'] 148,32139254,Consumption of a diet high in dairy leads to higher 15:0 in cholesteryl esters of healthy people when compared to diets high in meat and grain.,"BACKGROUND AND AIMS A higher dairy product intake has been associated to higher blood concentrations of 15:0 (pentadecanoic acid), 17:0 (margaric acid), and 14:0 (myristic acid). This study investigates whether a diet high in dairy products influences cholesteryl ester fatty acid concentrations of these specific fatty acids (FA). METHODS AND RESULTS In a randomized multiple cross-over study, 13 men and 17 women aged 22 ± 4 years with a BMI of 21.6 ± 2.2 kg/m 2 received 3 isocaloric intervention diets (dairy, meat or grain) in random order. For this post-hoc analysis, FA in plasma cholesteryl esters were measured using gas chromatography. We performed a linear mixed model per centered log-ratio transformed FA, adjusting for period, and the interaction between diet and period. Consumed total fat intake per controlled intervention diet was 31.0 ± 0.9 en%/day (dairy), 31.5 ± 0.6 en%/day (meat), and 28.4 ± 1.2 en%/day (grain), respectively. The dairy diet led to higher relative concentrations of 15:0 when compared to diets high in meat and grain, (β; 0.27, 95%CI: 0.18,0.37; p = 1.2 × 10 -5 , and β: 0.15; 95%CI: 0.06,0.24; p = 1.2 × 10 -2 , respectively). The dairy diet also led to higher 14:0 when compared to the meat diet (β: 0.34; 95%CI: 0.21,0.46; p = 6.0 × 10 -5 ), but not when compared to the grain diet. 17:0 did not differ between diets. CONCLUSION The plasma cholesteryl ester fraction after a diet high in dairy was characterized by higher 15:0 levels. Concentrations of 14:0 were only higher when comparing the FA profile after a diet high in dairy when compared to a diet high in meat. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT01314040.",2020,"The dairy diet also led to higher 14:0 when compared to the meat diet (β: 0.34; 95%CI: 0.21,0.46; p = ",['13 men and 17 women aged 22\xa0±\xa04 years with a BMI of 21.6\xa0±\xa02.2'],"['isocaloric intervention diets (dairy, meat or grain']","['plasma cholesteryl ester fraction', 'plasma cholesteryl esters']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008387', 'cui_str': 'Cholesteryl Esters'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",13.0,0.0405382,"The dairy diet also led to higher 14:0 when compared to the meat diet (β: 0.34; 95%CI: 0.21,0.46; p = ","[{'ForeName': 'Linda E T', 'Initials': 'LET', 'LastName': 'Vissers', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: l.e.t.vissers@umcutrecht.nl.'}, {'ForeName': 'Sabita S', 'Initials': 'SS', 'LastName': 'Soedamah-Muthu', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, the Netherlands; Center of Research on Psychological and Somatic Disorders (CORPS), Department of Medical and Clinical Psychology, Tilburg University, the Netherlands; Institute for Food, Nutrition and Health, University of Reading, Reading, UK.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Geleijnse', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Sluijs', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: I.Sluijs-2@umcutrecht.nl.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.01.006'] 149,32396519,"Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.","OBJECTIVE To describe the efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a post-hoc analysis of randomised controlled trials. METHODS Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment: conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS). Only patients who received tofacitinib 5 or 10 mg twice daily or placebo were included. Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3. Data were reported to month 6 (placebo to month 3) in the RA and PsA populations, and week 12 (tofacitinib and placebo) in the AS population. RESULTS Overall, 3330 patients were included in this analysis. In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6). In the AS population, pain improvements compared with placebo were observed at week 12. CONCLUSION Tofacitinib was associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic musculoskeletal diseases.",2020,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","['patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis', 'patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS', 'patients with inflammatory rheumatic musculoskeletal diseases', 'Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment', '3330 patients were included in this analysis']","['tofacitinib 5 or 10 mg twice daily or placebo', 'conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS', 'tofacitinib', 'placebo']","['multiple pain measures', 'pain improvements', ""Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3"", 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}]",3330.0,0.247993,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Department of Rheumatology, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Glasgow Biomedical Research Centre, Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Rheumatology Research Group, Swedish Medical Center and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Baer', 'Affiliation': 'Baer Weinberg MPC, Scarborough, Ontario, Canada.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Lukic', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gruben', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA David.Gruben@pfizer.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Ming-Ann', 'Initials': 'MA', 'LastName': 'Hsu', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Maniccia', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}]",RMD open,['10.1136/rmdopen-2019-001042'] 150,32335133,Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial.,"BACKGROUND & AIMS Telemedicine can be used to monitor determinants and outcomes of patients with chronic diseases, possibly increasing the quality and value of care. Telemedicine was found to reduce outpatient visits and hospital admissions for patients with inflammatory bowel diseases (IBD). We performed a full economic evaluation of telemedicine interventions in patients with IBD, comparing the cost-utility of telemedicine vs standard care. METHODS We performed a randomized trial of 909 patients with IBD at 2 academic and 2 non-academic hospitals in The Netherlands. Patients were randomly assigned to groups that received telemedicine (myIBDcoach; n = 465) or standard outpatient care (n = 444) and followed for 12 months. Costs were measured from a societal perspective. Direct healthcare costs were based on actual resource use. Indirect costs comprised self-reported hours sick leave from work, intervention costs (annual license fee of €40 per patient [$45]), and utility costs (assessed using EQ5D). Cost-utility and uncertainty were estimated using the non-parametric bootstrapping method. RESULTS Telemedicine resulted in lower mean annual costs of €547/patient [$612] (95% CI, €1029-2143 [$1150-2393]; mean costs of €9481 [$10,587] for standard care and €8924 [$9965] for telemedicine) without changing quality adjusted life years. At the Dutch threshold of €80,000 [$89,335] per quality adjusted life year, the intervention had increased incremental cost-effectiveness over standard care in 83% of replications and an incremental net monetary benefit of €707/patient [$790] (95% CI, €1241-2544 [$1386-2841]). CONCLUSIONS Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD. This self-management tool enables continuous registration of quality indicators and (patient-reported) outcomes and might help reorganize IBD care toward value-based healthcare. ClinicalTrials.gov no: NCT02173002.",2020,"CONCLUSIONS Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD.","['patients with IBD', 'patients with chronic diseases', 'patients with inflammatory bowel diseases (IBD', '909 patients with IBD at 2 academic and 2 non-academic hospitals in The Netherlands', 'Patients']","['Telemedicine-directed Specialized vs Standard Care', 'Telemedicine', 'telemedicine (myIBDcoach; n=465) or standard outpatient care', 'telemedicine interventions', 'telemedicine', 'telemedicine vs standard care']","['utility costs', 'mean annual costs', 'incremental cost-effectiveness', 'Cost-utility and uncertainty', 'outpatient visits and hospital admissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",909.0,0.11441,"CONCLUSIONS Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD.","[{'ForeName': 'Marin J', 'Initials': 'MJ', 'LastName': 'de Jong', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Maastricht University Medical Centre+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Rheumatology, Maastricht; Maastricht University Medical Centre+, CAPHRI - Care and Public Health Research Institute, Maastricht.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'van der Meulen-de Jong', 'Affiliation': 'Leiden University Medical Centre, Department of Gastroenterology and Hepatology, Leiden.'}, {'ForeName': 'Mariëlle J', 'Initials': 'MJ', 'LastName': 'Romberg-Camps', 'Affiliation': 'Zuyderland Medical Centre, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Sittard-Geleen.'}, {'ForeName': 'Ad A', 'Initials': 'AA', 'LastName': 'van Bodegraven', 'Affiliation': 'Zuyderland Medical Centre, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Sittard-Geleen.'}, {'ForeName': 'Nofel', 'Initials': 'N', 'LastName': 'Mahmmod', 'Affiliation': 'St Antonius Hospital, Department of Gastroenterology and Hepatology, Nieuwegein.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'Markus', 'Affiliation': ""Dutch Crohn's and Colitis Organisation, CCUVN, Woerden.""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Dijkstra', 'Affiliation': 'University Medical Centre Groningen, Department of Gastroenterology and Hepatology, Groningen.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Maastricht University Medical Centre+, CAPHRI - Care and Public Health Research Institute, Maastricht; Maastricht University, Department of Methodology and Statistics, Maastricht, Netherlands.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'van Tubergen', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Rheumatology, Maastricht; Maastricht University Medical Centre+, CAPHRI - Care and Public Health Research Institute, Maastricht.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Masclee', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Zuyderland Medical Centre, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Sittard-Geleen.'}, {'ForeName': 'Daisy M', 'Initials': 'DM', 'LastName': 'Jonkers', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Maastricht University Medical Centre+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht.'}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Pierik', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Maastricht University Medical Centre+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht. Electronic address: m.pierik@mumc.nl.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.038'] 151,32272356,"Changes in alcohol use, PTSD hyperarousal symptoms, and intervention dropout following veterans' use of VetChange.","OBJECTIVE Veterans of Iraq and Afghanistan conflicts report high rates of drinking, PTSD, and low rates of treatment engagement. Web interventions may help address unmet treatment need; unfortunately, little is known regarding outcomes or adherence to these interventions. In this study, we examined VetChange treatment outcomes and downstream effects of alcohol reduction on PTSD symptoms and intervention dropout rates over six months. METHOD Participants included 222 veterans (77.5% men, 78.3% White) between 22 and 57 (mean age = 36.02, SD = 7.19). All VetChange users completed a brief alcohol assessment and received personal feedback, then received full access to intervention content including psychoeducation; motivational and cognitive-behavioral modules for relapse prevention, goal-setting, social support, stress, anger, and sleep management; and mood and drink tracking. Veterans completed self-report measures of alcohol use and PTSD symptoms at baseline, one, three, and six months. RESULTS Alcohol use dropped by 43% over six months, p < .001, with the largest decrease occurring within the first month. Greater alcohol reduction in the first month predicted higher subsequent PTSD hyperarousal severity. Over half (52.3%) dropped out by month one, followed by 12.2% and 37.6% by months three and six. Hyperarousal symptoms, hypervigilance specifically, but not alcohol use predicted subsequent intervention dropout. CONCLUSION These results highlight the importance of attending to the association between alcohol use and PTSD symptom change in web-based interventions for veterans. The fact that hyperarousal symptoms were associated with elevated risk for intervention dropout signifies the need for online intervention refinement aimed at tailoring content to time-varying symptom presentations.",2020,"RESULTS Alcohol use dropped by 43% over six months, p < .001, with the largest decrease occurring within the first month.","['Participants included 222 veterans (77.5% men, 78.3% White) between 22 and 57 (mean age\u202f=\u202f36.02, SD\u202f=\u202f7.19']","['brief alcohol assessment and received personal feedback, then received full access to intervention content including psychoeducation; motivational and cognitive-behavioral modules for relapse prevention, goal-setting, social support, stress, anger, and sleep management; and mood and drink tracking', 'alcohol reduction']","['PTSD symptoms and intervention dropout rates', 'Hyperarousal symptoms, hypervigilance', 'subsequent PTSD hyperarousal severity', 'Greater alcohol reduction']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C1273382', 'cui_str': 'Sleep management'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.00943362,"RESULTS Alcohol use dropped by 43% over six months, p < .001, with the largest decrease occurring within the first month.","[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Livingston', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, Boston, MA, USA; Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA. Electronic address: nicholas.livingston@va.gov.'}, {'ForeName': 'Colin T', 'Initials': 'CT', 'LastName': 'Mahoney', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, Boston, MA, USA; Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ameral', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Brief', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Rubin', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Enggasser', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Litwack', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helmuth', 'Affiliation': 'Education Development Center, Waltham, MA, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Solhan', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenbloom', 'Affiliation': 'Boston University, School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Keane', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, Boston, MA, USA; Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106401'] 152,32328434,Engineered Polymersomes for the Treatment of Fish Odor Syndrome: A First Randomized Double Blind Olfactory Study.,"Trimethylamine (TMA) is a metabolite overtly present in patients suffering from trimethylaminuria (TMAU), a rare genetic disorder characterized by a strong ""fishy"" body odor. To date, no approved pharmacological treatment to sequester excess TMA on the skin of patients exists. Here, transmembrane pH gradient poly(isoprene)- block -poly(ethylene glycol) (PI- b -PEG) polymersomes are investigated for the topical removal of TMA. PI- b -PEG amphiphiles of varying chain length are synthesized and evaluated for their ability to form vesicular structures in aqueous media. The optimization of the PI/PEG ratio of transmembrane pH gradient polymersomes allows for the rapid and efficient capture of TMA both in solution and after incorporation into a topical hydrogel matrix at the pH of the skin. A subsequent double blind olfactory study reveals a significant decrease in perceived odor intensity after application of the polymersome-based formulation on artificial skin substrates that has been incubated in TMA-containing medium. This simple and novel approach has the potential to ease the burden of people suffering from TMAU.",2020,A subsequent double blind olfactory study reveals a significant decrease in perceived odor intensity after application of the polymersome-based formulation on artificial skin substrates that has been incubated in TMA-containing medium.,"['Fish Odor Syndrome', 'patients suffering from trimethylaminuria (TMAU']","['Trimethylamine (TMA', 'transmembrane pH gradient poly(isoprene)- block -poly(ethylene glycol']",[],"[{'cui': 'C0342739', 'cui_str': 'Trimethylaminuria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0077172', 'cui_str': 'trimethylamine'}, {'cui': 'C1138565', 'cui_str': 'deltapH'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0017951', 'cui_str': 'Glycol'}]",[],,0.0843966,A subsequent double blind olfactory study reveals a significant decrease in perceived odor intensity after application of the polymersome-based formulation on artificial skin substrates that has been incubated in TMA-containing medium.,"[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Pharmaceutical Sciences Department of Chemistry and Applied Biosciences ETH Zurich 8093 Zurich Switzerland.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Hebels', 'Affiliation': 'Institute of Pharmaceutical Sciences Department of Chemistry and Applied Biosciences ETH Zurich 8093 Zurich Switzerland.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Weitzel', 'Affiliation': 'Institute of Pharmaceutical Sciences Department of Chemistry and Applied Biosciences ETH Zurich 8093 Zurich Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kletzmayr', 'Affiliation': 'Institute of Pharmaceutical Sciences Department of Chemistry and Applied Biosciences ETH Zurich 8093 Zurich Switzerland.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Institute of Pharmaceutical Sciences Department of Chemistry and Applied Biosciences ETH Zurich 8093 Zurich Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steuer', 'Affiliation': 'Institute of Pharmaceutical Sciences Department of Chemistry and Applied Biosciences ETH Zurich 8093 Zurich Switzerland.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Leroux', 'Affiliation': 'Institute of Pharmaceutical Sciences Department of Chemistry and Applied Biosciences ETH Zurich 8093 Zurich Switzerland.'}]","Advanced science (Weinheim, Baden-Wurttemberg, Germany)",['10.1002/advs.201903697'] 153,32247156,Association between delirium prediction scores and days spent with delirium.,"PURPOSE To determine the correlation and discriminative value of the E-PRE-DELIRIC and PRE-DELIRIC scores with delirium exposure to evaluate the prognostic value of both models. METHODS A secondary analysis of a randomized clinical trial enrolling 1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2 days. Days spent with delirium (≥1 positive CAM-ICU) or coma (≥1 RASS ≤-4) in the 28-days after ICU admission were calculated. Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium. RESULTS The correlation between the overall E-PRE-DELIRIC and PRE-DELIRIC scores and days spent with delirium were: R = 0.08 (P = .005) and R = 0.26 (P < .001), respectively. The correlation between both prediction scores and days spent with coma or delirium were R = 0.21 (P < .0001) and R = 0.46 (P < .0001), respectively. The highest Area Under the Receiver Operating Characteristic for both E-PRE-DELIRIC [0.57 (95% CI:0.51-0.62)] and PRE-DELIRIC [0.58 (95% CI:0.53-0.62)] was found in the long delirium exposure group. CONCLUSION The E-PRE-DELIRIC and PRE-DELIRIC model each poorly correlate and discriminate with days spent with delirium in the 28 days after ICU admission.",2020,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"['1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2\xa0days', 'Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium']",[],"['overall E-PRE-DELIRIC and PRE-DELIRIC scores', 'prediction scores and days spent with coma or delirium']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",1506.0,0.138306,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"[{'ForeName': 'Hidde', 'Initials': 'H', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'School of Pharmacy, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. Electronic address: Mark.vandenBoogaard@radboudumc.nl.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.008'] 154,32333538,[Influence of warming needling technique on gastrointestinal reaction after hyperthermic intrape-ritoneal chemotherapy in patients with postoperation of colon cancer].,"OBJECTIVE To observe the effect of warming needling therapy on gastrointestinal reaction after hyperthermic intraperitoneal chemotherapy (HIPEC) in patients of spleen and stomach deficiency syndrome after colon cancer surgery. METHODS A total of 120 cases of HIPEC were randomized into observation group and control group, 60 cases in each. The patients of the two groups all received HIPEC. In the observation group, 1 h before HIPEC, warming needling technique was applied to Zusanli (ST36), Sanyinjiao (SP6) and Yinlingquan (SP9) and the even-needing technique of acupuncture was applied to Neiguan (PC6) for 30 min, and then the intravenous injection with Ondansetron was given 30 min before HIPEC. In the control group, The intravenous injection with Ondansetron was given 30 min before HIPEC. In the two groups, the changes in nausea, vomiting, abdominal distention, diarrhea, total bilirubin (TB), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and KPS score, as well as the average hospitalization length of stay were observed. RESULTS The total effective rates in the treatment of nausea, vomiting, abdominal distention and diarrhea were 91.67%(55/60), 93.33%(56/60), 80.00%(48/60) and 88.33%(53/60) in the observation group and were 78.33%(47/60), 78.33%(47/60), 63.33%(38/60) and 70.00%(42/60) in the control group respectively, and the total effective rate in the treatment of gastrointestinal reaction of HIPEC in the observation group was obviously higher than that in the control group( P <0.05). The KPS score and curative effect in the observation group was obviously higher than those of the control group( P <0.05), and the average hospitalization length of stay in the observation group was obviously reduced as compared with the control group ( P <0.05). There were no significant differences in serum TB, ALT and ALP contents between the two groups after treatment ( P >0.05). CONCLUSION The warming needling technique of acupuncture and moxibustion alleviates the gastrointestinal reaction, improves KPS score and reduces the hospitalization length of stay in HIPEC patients after the surgery of colon cancer and differentiated as the spleen and stomach deficiency in traditional Chinese medicine.",2020,"There were no significant differences in serum TB, ALT and ALP contents between the two groups after treatment ( P >0.05). ","['patients with postoperation of colon cancer', 'A total of 120 cases of HIPEC', 'patients of spleen and stomach deficiency syndrome after colon cancer surgery']","['warming needling therapy', 'Ondansetron', 'HIPEC', 'hyperthermic intrape-ritoneal chemotherapy', 'acupuncture and moxibustion', 'hyperthermic intraperitoneal chemotherapy (HIPEC', 'HIPEC, warming needling technique was applied to Zusanli (ST36), Sanyinjiao (SP6) and Yinlingquan (SP9) and the even-needing technique of acupuncture was applied to Neiguan (PC6', 'warming needling technique']","['average hospitalization length of stay', 'total effective rate', 'hospitalization length of stay', 'KPS score and curative effect', 'gastrointestinal reaction of HIPEC', 'nausea, vomiting, abdominal distention, diarrhea, total bilirubin (TB), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and KPS score, as well as the average hospitalization length of stay', 'gastrointestinal reaction', 'nausea, vomiting, abdominal distention and diarrhea', 'serum TB, ALT and ALP contents', 'KPS score', 'total effective rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0135624', 'cui_str': 'PC6 extract'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",120.0,0.0244505,"There were no significant differences in serum TB, ALT and ALP contents between the two groups after treatment ( P >0.05). ","[{'ForeName': 'Xu-Ying', 'Initials': 'XY', 'LastName': 'Gu', 'Affiliation': 'First Clinical Medical College of Guangzhou University of Traditional Chinese Medicine, Guangzhou 510000, China.'}, {'ForeName': 'Zhi-Qing', 'Initials': 'ZQ', 'LastName': 'Gao', 'Affiliation': 'First Clinical Medical College of Guangzhou University of Traditional Chinese Medicine, Guangzhou 510000, China.'}, {'ForeName': 'Zi-Jing', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal and Thyroid Surgery, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou 510000.'}, {'ForeName': 'Zhan-Ming', 'Initials': 'ZM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal and Thyroid Surgery, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou 510000.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Xie', 'Affiliation': 'Department of Gastrointestinal and Thyroid Surgery, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou 510000.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190385'] 155,32333539,[Clinical effect of long-snake moxibustion on lumbago of cold-dampness type].,"OBJECTIVE To observe the effect of long-snake moxibustion on pain, functional disorder and body constitution in the patients with lumbago of cold-dampness type. METHODS A total of 90 patients with lumbago of cold-dampness type were randomized into long-snake moxibustion, acupuncture and medication groups, 30 cases in each group. In the long-snake moxibustion group, long-snake moxibustion was exerted on the spinal (between Dazhui[GV14] and Yaoshu[GV2]) with the self-prepared moxa powder formula combined with fresh ginger and moxa wool, once a week, for 4 weeks. Regular acupuncture was given to the acupuncture group, 30 min each time, once a day, 8 times as a treatment course, at the interval of 2 days between the courses. The duration of treatment was 1 month. In the medication group, Diclofenac Sodium was prescribed for oral administration, 25 mg each time, three times a day, and Mecobalamine tablets, 0.5 mg each time, 3 times a day. The duration of medication was 1 month. Before and after treatment, the differences were evaluated in the scores of visual analog scale (VAS), the present pain intensity(PPI), Oswestry disability index (ODI) and the scale of yang-deficiency body constitution among the 3 groups. RESULTS After the treatment, VAS and PPI score and ODI were significantly reduced in the patients of the 3 groups as compared with those before treatment (all P <0.05). Compared with the medication group, ODI score was significantly reduced in the long-snake moxibustion group and the acupuncture group ( P <0.05). After the treatment, the scores of the scale of yang-deficiency body constitution were significantly reduced in the long-snake moxibustion group and the acupuncture group ( P <0.05) as compared with those before the treatment, but not statistically significant in the medication group in comparison before and after the treatment ( P >0.05). The score of the scale of yang-deficiency body constitution in the long-snake moxibustion group was significantly lower than that in the acupuncture group and the medication group ( P <0.05). Regarding the clinical effect, the effective rate was 93.33% (28/30) in the long-snake moxibustion group and it was 86.67% (26/30) in the acupuncture group and 73.33% (22/30) in the medication group after the treatment. The effective rate in the long-snake moxibustion group was significantly higher than those in the acupuncture group and the medication group ( P <0.05). CONCLUSION The long-snake moxibustion therapy can achieve significant effect on lumbago of cold-dampness type. This therapy can alleviate pain, relieve the functional disorders and improve the conditions of body constitution in the patients. Hence, it is applicable for the clinical promotion.",2020,"After the treatment, VAS and PPI score and ODI were significantly reduced in the patients of the 3 groups as compared with those before treatment (all P <0.05).","['patients with lumbago of cold-dampness type', '90 patients with lumbago of cold-dampness type']","['Diclofenac Sodium', 'long-snake moxibustion', 'acupuncture', 'snake moxibustion, acupuncture and medication', 'Regular acupuncture']","['score of the scale of yang-deficiency body constitution', 'scores of visual analog scale (VAS), the present pain intensity(PPI), Oswestry disability index (ODI) and the scale of yang-deficiency body constitution', 'pain, functional disorder and body constitution', 'effective rate', 'lumbago of cold-dampness type', 'ODI score', 'VAS and PPI score and ODI', 'scores of the scale of yang-deficiency body constitution', 'duration of medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085258', 'cui_str': 'Yang deficiency'}, {'cui': 'C0005886', 'cui_str': 'Body Constitution'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0277785', 'cui_str': 'Functional disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",90.0,0.0282304,"After the treatment, VAS and PPI score and ODI were significantly reduced in the patients of the 3 groups as compared with those before treatment (all P <0.05).","[{'ForeName': 'Xiu-Wu', 'Initials': 'XW', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hongdu Hospital of Chinese Medicine, Nanchang 330006, China.'}, {'ForeName': 'Chen-Ying', 'Initials': 'CY', 'LastName': 'Deng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hongdu Hospital of Chinese Medicine, Nanchang 330006, China.'}, {'ForeName': 'Fen-Fen', 'Initials': 'FF', 'LastName': 'Qiu', 'Affiliation': 'Department of Rehabilitation of Jiangxi Integrated Chinese and Western Medicine Hospital, Nanchang 330004.'}, {'ForeName': 'Le-le', 'Initials': 'LL', 'LastName': 'Geng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hongdu Hospital of Chinese Medicine, Nanchang 330006, China.'}, {'ForeName': 'Xi-Jing', 'Initials': 'XJ', 'LastName': 'Yu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hongdu Hospital of Chinese Medicine, Nanchang 330006, China.'}, {'ForeName': 'Li-Mei', 'Initials': 'LM', 'LastName': 'Tang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hongdu Hospital of Chinese Medicine, Nanchang 330006, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hongdu Hospital of Chinese Medicine, Nanchang 330006, China.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Nie', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hongdu Hospital of Chinese Medicine, Nanchang 330006, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190569'] 156,31899372,Design and sample characteristics of COordinated Oral health Promotion (CO-OP) Chicago: A cluster-randomized controlled trial.,"COordinated Oral health Promotion (CO-OP) Chicago is a two-arm cluster-randomized trial with a wait-list control. The primary aim is to evaluate the efficacy of an oral health community health worker (CHW) intervention to improve oral health behaviors in low-income, urban children under the age of three years. Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting. This paper describes progress toward achieving these aims. Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois. Sites were cluster-randomized to CHW intervention or usual services (a wait-list control). The intervention is oral health support from CHWs delivered in four visits to individual families over one year. The trial sample consists of 420 child/caregiver dyads enrolled at the 20 participating sites over 11 months. Participant demographics varied across the sites, but primary outcomes values at baseline did not. Data on brushing frequency, plaque, and other oral health behaviors are collected at three timepoints: baseline, 6-, and 12-months. The primary analysis will assess differences in caregiver-reported child brushing frequency and observed plaque score between the two arms at 12-months. The trial is currently in the active intervention phase. The trial's cluster-randomized controlled design takes a real-world approach by integrating into existing health and social service agencies and collecting data in participant homes. Results will address an important child health disparity. ClinicalTrials.gov identifier: NCT03397589. CLINICAL TRIAL REGISTRATION: University of Illinois at Chicago Protocol Record 2017-1090. National Institutes of Dental & Craniofacial Research of the National Institutes of Health (NIDCR) Protocol Number: 17-074-E. NCT03397589.",2020,"Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting.","['National Institutes of Dental & Craniofacial Research of the National Institutes of Health', 'low-income, urban children under the age of three years', '420 child/caregiver dyads enrolled at the 20 participating sites over 11\u202fmonths', 'participant homes', 'University of Illinois at Chicago Protocol Record 2017-1090', 'Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois']","['COordinated Oral health Promotion (CO-OP', 'oral health community health worker (CHW) intervention', 'CHW intervention or usual services (a wait-list control']","['caregiver-reported child brushing frequency and observed plaque score', 'brushing frequency, plaque, and other oral health behaviors', 'oral health behaviors']","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0035168'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}]","[{'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion (regime/therapy)'}, {'cui': 'C0029162'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0029162'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.126316,"Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting.","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Martin', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States; University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States. Electronic address: mollyma@uic.edu.'}, {'ForeName': 'Lacey J', 'Initials': 'LJ', 'LastName': 'Zimmerman', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States.'}, {'ForeName': 'Genesis F', 'Initials': 'GF', 'LastName': 'Rosales', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Helen H', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States; University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Nattanit', 'Initials': 'N', 'LastName': 'Songthangtham', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Pugach', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Sandoval', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Avenetti', 'Affiliation': 'University of Illinois at Chicago, College of Dentistry, 801 S Paulina St, Chicago, IL 60612, United States.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Alvarez', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Gansky', 'Affiliation': 'University of California, Box# 1361, San Francisco, CA 94143, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105919'] 157,32194255,Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study.,"BACKGROUND Laparoscopy is the gold standard for many surgical procedures and is embraced as minimally invasive surgery in the enhanced recovery after surgery programme. Lowering intra-abdominal pressure during laparoscopy may decrease the degree of surgical injury and further enhance patient outcomes. This study aims to assess the effect of low pressure pneumoperitoneum on peritoneal perfusion during laparoscopic surgery. MATERIALS AND METHODS We performed a prospective randomized intervention study in 30 adults undergoing colorectal robot assisted laparoscopic surgery at a secondary care medical center in the Netherlands between June and December 2018. A 3 min video recording of the parietal peritoneum was made with the Da Vinci® Firefly mode following intravenous injection of 0.2 mg/kg indocyanine green at a pneumoperitoneum pressure of 8, 12 or 16 mmHg. Observers were blinded for the level of intra-abdominal pressure that was used. Fluorescent intensity in [-] over time was extracted from each video in MATLAB. Time to reach maximal fluorescent intensity (TMFI) and maximum fluorescent intensity (MFI) were compared among groups. The study was registered at clinicaltrials.gov (NCT03928171). RESULTS Mean TMFI was shorter at low pressure (8 mmHg) than standard pressure (12 and 16 mmHg): 44 ± 12 versus 58 ± 18 s (p = 0.032), respectively. Mean MFI was higher at 8 mmHg than 12 and 16 mmHg (222 ± 25 versus 188 ± 54, p = 0.033). Regression analysis identified intra-abdominal pressure, mean arterial pressure and female gender as significant predictors of peritoneal perfusion. CONCLUSION Low pressure pneumoperitoneum was associated with improved perfusion of the parietal peritoneum. Current available evidence supported feasibility and enhanced postoperative recovery. Future investigations should focus on optimizing factors that facilitate lower intra-abdominal pressure and explore effects on other clinically relevant patient outcomes such as anastomotic leakage and immune homeostasis.",2020,Mean TMFI was shorter at low pressure (8 mmHg) than standard pressure (12 and 16 mmHg): 44 ± 12 versus 58 ± ,['30 adults undergoing colorectal robot assisted laparoscopic surgery at a secondary care medical center in the Netherlands between June and December 2018'],"['fluorescent imaging during laparoscopic surgery', 'indocyanine green', 'low pressure pneumoperitoneum']","['peritoneal perfusion', 'Lowering intra-abdominal pressure', 'Mean MFI', 'Time to reach maximal fluorescent intensity (TMFI) and maximum fluorescent intensity (MFI', 'Fluorescent intensity', 'Mean TMFI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]","[{'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",30.0,0.229307,Mean TMFI was shorter at low pressure (8 mmHg) than standard pressure (12 and 16 mmHg): 44 ± 12 versus 58 ± ,"[{'ForeName': 'Kim I', 'Initials': 'KI', 'LastName': 'Albers', 'Affiliation': 'Radboudumc Department of Surgery, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands; Radboudumc Department of Anaesthesiology, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands. Electronic address: kim.albers@radboudumc.nl.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Polat', 'Affiliation': 'Canisius Wilhelmina Hospital Department of Surgery, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Loonen', 'Affiliation': 'Radboudumc Technology Centre 3D Lab, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Leon J', 'Initials': 'LJ', 'LastName': 'Graat', 'Affiliation': 'St Antonius Hospital Department of Surgery, Koekoekslaan 1, 3435 CM, Nieuwegein, the Netherlands.'}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Mulier', 'Affiliation': 'AZ Sint-Jan Brugge-Oostende Department of Anaesthesiology, Kaïrostraat 84, 8400, Oostende, Belgium.'}, {'ForeName': 'Marc Mj', 'Initials': 'MM', 'LastName': 'Snoeck', 'Affiliation': 'Canisius Wilhelmina Hospital Department of Anaesthesiology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, the Netherlands.'}, {'ForeName': 'Ivo F', 'Initials': 'IF', 'LastName': 'Panhuizen', 'Affiliation': 'Canisius Wilhelmina Hospital Department of Anaesthesiology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, the Netherlands.'}, {'ForeName': 'Ad A', 'Initials': 'AA', 'LastName': 'Vermulst', 'Affiliation': 'Statistician at GGZ (Mental Health Care) Oost Brabant, Kluisstraat, 2 5427 EM, Boekel, the Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Scheffer', 'Affiliation': 'Radboudumc Department of Anaesthesiology, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Warlé', 'Affiliation': 'Radboudumc Department of Surgery, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.019'] 158,31678222,Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial.,"OBJECTIVE To compare the effects of unilateral, proximal arm robot-assisted therapy combined with hand functional electrical stimulation with intensive conventional therapy for restoring arm function in survivors of subacute stroke. DESIGN This was a single-blinded, randomized controlled trial. SETTING Inpatient rehabilitation university hospital. PARTICIPANTS Patients (N=40) diagnosed as having ischemic stroke (time since stroke <8wk) and upper limb impairment were enrolled. INTERVENTIONS Participants randomized to the experimental group received 30 sessions (5 sessions/wk) of robot-assisted arm therapy and hand functional electrical stimulation (RAT+FES). Participants randomized to the control group received a time-matched intensive conventional therapy. MAIN OUTCOME MEASURES The primary outcome was arm motor recovery measured with the Fugl-Meyer Motor Assessment. Secondary outcomes included motor function, arm spasticity, and activities of daily living. Measurements were performed at baseline, after 3 weeks, at the end of treatment, and at 6-month follow-up. Presence of motor evoked potentials (MEPs) was also measured at baseline. RESULTS Both groups significantly improved all outcome measures except for spasticity without differences between groups. Patients with moderate impairment and presence of MEPs who underwent early rehabilitation (<30d post stroke) demonstrated the greatest clinical improvements. CONCLUSIONS RAT+FES was no more effective than intensive conventional arm training. However, at the same level of arm impairment and corticospinal tract integrity, it induced a higher level of arm recovery.",2020,Both groups significantly improved all outcome measures except for spasticity without differences between groups.,"['Forty patients diagnosed with ischemic stroke (time since stroke <8 weeks) and upper limb impairment were enrolled', 'Inpatient Rehabilitation University Hospital', 'subacute stroke survivors']","['robot-assisted arm training plus hand functional electrical stimulation', 'unilateral, proximal arm robot-assisted therapy combined with hand functional electrical stimulation to intensive conventional therapy', 'robot-assisted arm therapy and hand functional electrical stimulation (RAT + FES', 'time-matched intensive conventional therapy (ICT']","['motor evoked potentials (MEPs', 'motor function, arm spasticity and activities of daily living', 'spasticity', 'motor recovery measured with the Fugl-Meyer Motor Assessment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0877408', 'cui_str': 'Arm spasticity'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",40.0,0.430265,Both groups significantly improved all outcome measures except for spasticity without differences between groups.,"[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy. Electronic address: s.straudi@ospfe.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baroni', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Doctoral Program in Translational Neurosciences and Neurotechnologies, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mele', 'Affiliation': 'Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Craighero', 'Affiliation': 'Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Medical Science Department, Center for Clinical Epidemiology, Ferrara University, Ferrara, Italy; Department of Biomedical and Neuromotor Sciences, Bologna University, Bologna, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.09.016'] 159,31891694,Lung Volume Reduction Surgery: Reinterpreted With Longitudinal Data Analyses Methodology.,"BACKGROUND The largest randomised controlled trial evaluating results of lung volume reduction surgery (LVRS) was conducted by the National Emphysema Treatment Trial (NETT) that published a series of reports for outcomes up to 24 months. However, patient outcomes were difficult to interpret due to limitations in and the presentation of conventional statistical analyses applied to longitudinal data. We reevaluated the NETT results using longitudinal data methodology to report longer-term outcomes to facilitate interpretation by clinicians and patients who are considering LVRS for emphysema management. METHODS Trial data were released by the United States National Institutes of Health and the National Heart, Lung, and Blood Institute and analyzed using a mixed-effects model. Data on the difference in lung function variables between patients receiving LVRS vs medical care out to 5 years were estimated and are presented. RESULTS The 5-year differences in patients randomised to LVRS were a small but sustained improvement in lung function indicators of forced expiratory volume in 1 second, forced vital capacity, and residual volume of +1.4% (P < .001), +3.44% (P < .001) and -19.49% (P < .001) of the predicted values, respectively. With regards to physiological function, the 5-year difference in patients randomised to LVRS was an overall 0.89 W improvement in maximum workload (P = .069), -4.12 improvement in shortness of breath score (P < .001), and 0.088 improvement in quality of well-being score (P = .102). CONCLUSIONS Our results suggest that LVRS continues to have an important role in the treatment of patients with severe emphysema, with long-term benefits to lung function variables and a sustained improvement to the relief of dyspnea.",2020,"The five-year differences in patients randomised to LVRS was a small but sustained improvement in lung function parameters of FEV1, FVC and RV of +1.4% (P<0.001), +3.44% ((P<0.001) and -19.49% (P<0.001) of the predicted values respectively.","['Trial data was released by the United States National Institute of Health and the United States National Heart, Lung and Blood Institute, and analysed using a mixed effects model', 'clinicians and patients who are considering LVRS for emphysema management']","['LVRS', 'lung volume reduction surgery (LVRS', 'Lung Volume Reduction Surgery']","['shortness of breath score', 'maximum workload', 'quality of well-being score', 'lung function parameters of FEV1, FVC and RV', 'lung function parameters']","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0005768'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]","[{'cui': 'C0375931', 'cui_str': 'Lung volume reduction surgery'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0426106,"The five-year differences in patients randomised to LVRS was a small but sustained improvement in lung function parameters of FEV1, FVC and RV of +1.4% (P<0.001), +3.44% ((P<0.001) and -19.49% (P<0.001) of the predicted values respectively.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Imperial College and the Academic Division of Thoracic Surgery, Royal Brompton Hospital, London, United Kingdom. Electronic address: e.lim@rbht.nhs.uk.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Sousa', 'Affiliation': 'Department of Health and Medicine, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Imperial College and Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Diggle', 'Affiliation': 'Department of Health and Medicine, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Goldstraw', 'Affiliation': 'Imperial College and the Academic Division of Thoracic Surgery, Royal Brompton Hospital, London, United Kingdom.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.11.018'] 160,31897748,Effects of whole-body vibration and high impact exercises on the bone metabolism and functional mobility in postmenopausal women.,"INTRODUCTION This study determined the effects of whole-body vibration (WBV) and high-impact exercises on postmenopausal women. MATERIALS AND METHODS In this randomized controlled 6-month interventional trial, 58 eligible postmenopausal women were assigned to WBV training group, high-impact training group, or control group. Bone mineral density (BMD) of the lumbar spine and femur were measured by dual-energy X-ray absorptiometry. Additionally, the serum osteocalcin (OC) and C-terminal telopeptide of type I collagen levels were also measured. The functional mobility was assessed using the Timed Up and Go (TUG) test, and fall index was measured using static posturography. The health-related quality of life (HRQoL) and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis and Beck Depression Inventory, respectively. RESULTS The BMD at the femoral neck (p = 0.003) and L 2 -L 4 (p = 0.005) regions increased significantly in the WBV group compared to the control group. However, in the high-impact exercise group there were no significant effects on the lumbar spine and femoral neck. The serum OC decreased significantly in the WBV group and increased significantly in both the high-impact exercise and control groups (p < 0.001). The TUG scores decreased significantly in both training groups compared to the control group (p < 0.05). Finally, in both exercise groups, HRQoL and depressive symptoms improved (p < 0.001). CONCLUSIONS Our data suggest that the WBV can prevent bone loss in postmenopausal women. These findings also indicate that WBV and high-impact training programs improve functional mobility, HRQoL and depressive symptoms in postmenopausal women.",2020,The serum OC decreased significantly in the WBV group and increased significantly in both the high-impact exercise and control groups (p < 0.001).,"['58 eligible postmenopausal women', 'postmenopausal women']","['whole-body vibration and high impact exercises', 'WBV', 'whole-body vibration (WBV) and high-impact exercises', 'WBV training group, high-impact training group, or control group']","['health-related quality of life (HRQoL) and depressive symptoms', 'TUG scores', 'bone metabolism and functional mobility', 'functional mobility, HRQoL and depressive symptoms', 'lumbar spine and femoral neck', 'I collagen levels', 'serum osteocalcin (OC) and C-terminal telopeptide of type', 'Quality of Life Questionnaire of the European Foundation for Osteoporosis and Beck Depression Inventory', 'BMD at the femoral neck', 'HRQoL and depressive symptoms', 'Bone mineral density (BMD) of the lumbar spine and femur', 'bone loss', 'functional mobility', 'serum OC', 'Timed Up and Go (TUG) test, and fall index']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",58.0,0.0203392,The serum OC decreased significantly in the WBV group and increased significantly in both the high-impact exercise and control groups (p < 0.001).,"[{'ForeName': 'Ekin Ilke', 'Initials': 'EI', 'LastName': 'Sen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Millet Cad, 34093, Istanbul, Turkey. ekinozgorgu@gmail.com.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Millet Cad, 34093, Istanbul, Turkey.'}, {'ForeName': 'Nurten', 'Initials': 'N', 'LastName': 'Eskiyurt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Millet Cad, 34093, Istanbul, Turkey.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-019-01072-2'] 161,32088652,Comparison of MS inflammatory activity in women using continuous versus cyclic combined oral contraceptives.,"BACKGROUND Many women with multiple sclerosis (MS) report fluctuating symptoms across their menstrual cycle. Oral contraceptives (OCs) alter hormonal levels across the menstrual cycle. While cyclic OCs administer hormones for 21 days, followed by a week of placebo, continuous OCs can administer continuous doses of hormones for up to 3 months. Previous studies have suggested that OC use is associated with lower MS-related inflammation. We hypothesized that due to reduced hormonal fluctuations, women with MS might experience less inflammatory activity (clinical relapses+MRI) on continuous OCs than on cyclic OCs. METHODS We performed a retrospective analysis of prospectively collected data. For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation, we extracted data on OC use from the Electronic Medical Records (EMR). All variables were confirmed using manual clinical chart review. We identified 19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type. Inflammatory activity in the two groups was then compared using log-rank tests (time to new relapse, new T2-weighted lesion formation, and gadolinium-enhancing lesion formation) and t-tests (annualized relapse rate). We also performed subgroup analyses in women with at least 1 year (N = 28) and 2 years (N = 21) of clinical observation. A power calculation was performed. RESULTS There was no difference in time to relapse (p = 0.50) between continuous and cycling OC users. However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05). In patients with at least 1 year of observation, there was a significant difference in time to T2 lesion formation (p = 0.03) and time to contrast-enhancing lesion formation (p = 0.02). CONCLUSION In this exploratory study, women on continuous OCs showed a trend towards less inflammatory activity on MRI relative to women on cyclic OCs. This difference was not reflected in relapse rates. We estimate that 342 patients would be required for an adequately powered cohort study to evaluate such an effect. Our findings provide reassurance that for women using continuous OCs to alleviate menstrual fluctuations in symptoms, there is not an increase in MS-related inflammatory activity.",2020,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","['19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type', 'women with at least 1 year (N\u202f=\u202f28) and 2 years (N\u202f=\u202f21) of clinical observation', '342 patients', 'For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation', 'women using continuous versus cyclic combined oral contraceptives']","['Oral contraceptives (OCs', 'placebo, continuous OCs']","['MS inflammatory activity', 'time to relapse', 'time to contrast-enhancing lesion formation', 'Inflammatory activity', 'relapse rates', 'longer time to contrast-enhancing lesion formation', 'longer time to T2 lesion formation', 'time to T2 lesion formation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",342.0,0.070475,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","[{'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chelsea.chen@ucsf.edu.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Krishnakumar', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: tanya.krishnakumar@ucsf.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rowles', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: william.rowles@ucsf.edu.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: annika.anderson@ucsf.edu.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chao.zhao@ucsf.edu.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Do', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: lvtieu@gmail.com.'}, {'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Bove', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: riley.bove@ucsf.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.101970'] 162,32061833,Associations of Caregiver-Oncologist Discordance in Prognostic Understanding With Caregiver-Reported Therapeutic Alliance and Anxiety.,"CONTEXT Discordance in prognostic understanding between caregivers of adults with advanced cancer and the oncologist may shape caregivers' views of the oncologist and bereavement outcomes. OBJECTIVES We examined prospective associations of caregiver-oncologist discordance with caregiver-oncologist therapeutic alliance and caregiver anxiety after patient death. METHODS We conducted a secondary analysis of data collected in a cluster randomized controlled trial from August 2012 to June 2014 in Western New York and California. At enrollment, caregivers and oncologists used a seven-point scale to rate their beliefs about the patient's curability and living two years or more: 100%, about 90%, about 75%, about 50 of 50, about 25%, about 10%, and 0%. Discordance was defined as a difference of two points or more. Outcomes at seven months after patient death included caregiver-oncologist therapeutic alliance (The Human Connection scale, modified into five items) and caregiver anxiety (Generalized Anxiety Disorder-7). We conducted multivariable linear regression models to assess the independent associations of discordance with alliance and anxiety. RESULTS We included 97 caregivers (mean age 63) and 38 oncologists; 41% of caregiver-oncologist dyads had discordant beliefs about the patient's curability, and 63% of caregiver-oncologist dyads had discordant beliefs about living two years or more. On multivariate analysis, discordance in beliefs about curability was associated with lower anxiety (β = -2.20; SE 0.77; P = 0.005). Discordance in beliefs about length of life was associated with a weaker alliance (β = -5.87; SE = 2.56; P = 0.02). CONCLUSION A better understanding of how caregivers understand and come to terms with poor prognoses will guide interventions to improve cancer care delivery and outcomes of cancer treatment.",2020,"On multivariate analysis, discordance in beliefs about curability was associated with lower anxiety (β=-2.20, SE=0.77, p=0.005).","['caregivers of adults with advanced cancer', 'caregiver-oncologist discordance with caregiver-oncologist therapeutic alliance and caregiver anxiety following patient death', 'August 2012 to June 2014 in Western New York and California', ""97 caregivers (mean age=63) and 38 oncologists; 41% of caregiver-oncologist dyads had discordant beliefs about the patient's curability and 63% of caregiver-oncologist dyads had discordant beliefs about living ≥2 years""]",[],"['Discordance in beliefs about length of life', 'caregiver-oncologist therapeutic alliance [modified 5-item Human Connection (THC) scale] and caregiver anxiety (Generalized Anxiety Disorder-7']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0023980', 'cui_str': 'Length of Life'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]",97.0,0.0754677,"On multivariate analysis, discordance in beliefs about curability was associated with lower anxiety (β=-2.20, SE=0.77, p=0.005).","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. Electronic address: kahpoh_loh@urmc.rochester.edu.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Department of Family Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, USA; Cornell Center for Research on End-of-Life Care, New York, New York, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Plumb', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ladwig', 'Affiliation': 'Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Sindhuja', 'Initials': 'S', 'LastName': 'Kadambi', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Melisa L', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'Division of Hematology/Oncology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'An', 'Affiliation': 'Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Division of Nephrology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.02.005'] 163,31578136,Efficacy of zinc supplementation in the management of acute diarrhoea: a randomised controlled trial.,"Background : Zinc has been recommended for the treatment of acute diarrhoea; however, there are heterogeneous reports regarding its efficacy. Aim : This study investigated the efficacy of zinc supplementation on the treatment outcomes of children admitted to hospital with acute diarrhoea. Methods : A double-blind, randomised, placebo-controlled trial was conducted in the Srinakharinwirot University Hospital's Paediatric Department, Thailand. Eligible children were randomly allocated to receive either zinc bisglycinate (15 mg elemental zinc) or a placebo. The study protocol was registered in the Thai Clinical Trials Registry (TCTR20190423004). Results : Of 86 patients, 50 (58.1%) were male and the mean age (range) was 2.5 years (6 months to 9.3 years). The median (IQR) number of hours to recovery from diarrhoea was significantly less in the zinc group than in the controls [44 (24-48) vs 52 (36-80) hours, respectively, p <  0.01]. The median (IQR) number of stools was significantly lower in the zinc group [5 (3-12)] than in the controls [7 (4-17), p = 0.02]. The median (IQR) duration of intravenous fluid therapy was 40 (24-56) hours in the zinc group and 56 (40-73) in the control group ( p < 0.01). The duration of hospitalisation was 60 (44-72) hours in the zinc group and 84 (56-136) hours in the controls ( p < 0.01). There was good compliance by all participants in both groups. Conclusion : Zinc supplementation can reduce the time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools. Zinc supplementation is recommended as a routine strategy for Thai children with acute diarrhoea.",2020,"Zinc supplementation can reduce the time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools.","['Eligible children', 'Of 86 patients, 50 (58.1%) were male and the mean age (range) was 2.5\xa0years (6\xa0months to 9.3\xa0years', 'children admitted to hospital with acute diarrhoea', ""Srinakharinwirot University Hospital's Paediatric Department, Thailand"", 'Thai children with acute diarrhoea', 'acute diarrhoea']","['zinc supplementation', ' ', 'placebo', 'zinc bisglycinate', 'Zinc supplementation']","['duration of hospitalisation', 'median (IQR) number of stools', 'time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools', 'median (IQR) duration of intravenous fluid therapy', 'median (IQR) number of hours to recovery from diarrhoea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0337910', 'cui_str': 'Thai'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action (observable entity)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",86.0,0.388735,"Zinc supplementation can reduce the time to resolution of acute diarrhoea, the length of hospital stay and the frequency of stools.","[{'ForeName': 'Lakkana', 'Initials': 'L', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Preventive Medicine, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Sanguansak', 'Initials': 'S', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}]",Paediatrics and international child health,['10.1080/20469047.2019.1673548'] 164,31707465,"Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial.","INTRODUCTION Procollagen type I N-terminal propeptide (P1NP), a bone formation marker, reportedly predicts bone mineral density (BMD) response to teriparatide treatment in treatment-naive patients with osteoporosis. Results from a randomized, phase 3, open-label, active-controlled trial- STRUCTURE-showed that in patients previously treated with bisphosphonates, romosozumab led to gains in hip BMD, which were not observed with teriparatide. This post hoc analysis investigated the comparative utility of early changes in P1NP in predicting BMD response in patients who participated in the STRUCTURE trial, which enrolled patients who switched treatment from bisphosphonates to romosozumab/teriparatide. MATERIALS AND METHODS Postmenopausal women (aged 55-90 years) with osteoporosis who had previously taken bisphosphonates were randomized to receive open-label subcutaneous romosozumab (210 mg once monthly; n = 218) or teriparatide (20 µg once daily; n = 218) for 12 months. BMD was assessed by dual-energy X-ray absorptiometry at the proximal femur and lumbar spine (LS) at baseline and months 6 and 12. To assess the utility of P1NP, the positive predictive value of increase from baseline in P1NP of > 10 µg/L at month 1 and achievement of various thresholds of percent change from baseline in BMD at month 12 were evaluated. RESULTS Overall, 95% (191/202) of patients in the romosozumab group and 91% (183/201) in the teriparatide group demonstrated an increase in P1NP of > 10 µg/L from baseline at month 1. Among these patients, 18% and 3% of romosozumab-treated patients versus 60% and 12% of teriparatide-treated patients showed no increase from baseline (i.e., ≤ 0%) in total hip and LS BMD, respectively, at month 12. These data indicate that in patients switching from bisphosphonates to a bone-forming therapy, increases in P1NP do not help predict the hip BMD response. Although most patients treated with either teriparatide or romosozumab showed an increase in P1NP, the majority of patients on romosozumab showed an increase in hip BMD, while more than half of the patients on teriparatide did not. Teriparatide therapy did not increase total hip BMD in the majority of patients who transitioned from bisphosphonates to teriparatide. CONCLUSIONS Thus, increases in P1NP were not predictive of BMD response in the teriparatide group because in approximately 60% of the patients who were administered teriparatide, the hip BMD decreased independent of the change in P1NP levels.",2020,"Teriparatide therapy did not increase total hip BMD in the majority of patients who transitioned from bisphosphonates to teriparatide. ","['patients who participated in the STRUCTURE trial, which enrolled patients who switched treatment from bisphosphonates to romosozumab/teriparatide', 'patients transitioned from', 'treatment-naive patients with osteoporosis', 'P1NP of\u2009>\u200910', 'Postmenopausal women (aged 55-90\xa0years) with osteoporosis who had previously taken bisphosphonates']","['open-label subcutaneous romosozumab', 'alendronate to romosozumab or teriparatide', 'bisphosphonates, romosozumab', 'teriparatide', 'Teriparatide therapy', 'teriparatide or romosozumab']","['P1NP', 'total hip BMD', 'BMD', 'hip BMD', 'BMD response', 'bone turnover, and bone mineral density', 'bone mineral density (BMD) response', 'P1NP levels', 'hip BMD response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C3661283'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3661283'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C1562708', 'cui_str': 'Teriparatide therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0457693,"Teriparatide therapy did not increase total hip BMD in the majority of patients who transitioned from bisphosphonates to teriparatide. ","[{'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Takada', 'Affiliation': 'Kitago Orthopedic Clinic, Hokkaido, Japan. jtakada@kitago-ortho.com.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Dinavahi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Miyauchi', 'Affiliation': 'Miyauchi Medical Center, Osaka, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hamaya', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Hirama', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Cassandra E', 'Initials': 'CE', 'LastName': 'Milmont', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-019-01057-1'] 165,32334074,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,"BACKGROUND Dementia with Lewy bodies (DLB) is the second most common form of dementia. Current symptomatic treatment with medications remains inadequate. Deep brain stimulation of the nucleus basalis of Meynert (NBM DBS) has been proposed as a potential new treatment option in dementias. OBJECTIVE To assess the safety and tolerability of low frequency (20 Hz) NBM DBS in DLB patients and explore its potential effects on both clinical symptoms and functional connectivity in underlying cognitive networks. METHODS We conducted an exploratory randomised, double-blind, crossover trial of NBM DBS in six DLB patients recruited from two UK neuroscience centres. Patients were aged between 50 and 80 years, had mild-moderate dementia symptoms and were living with a carer-informant. Patients underwent image guided stereotactic implantation of bilateral DBS electrodes with the deepest contacts positioned in the Ch4i subsector of NBM. Patients were subsequently assigned to receive either active or sham stimulation for six weeks, followed by a two week washout period, then the opposite condition for six weeks. Safety and tolerability of both the surgery and stimulation were systematically evaluated throughout. Exploratory outcomes included the difference in scores on standardised measurements of cognitive, psychiatric and motor symptoms between the active and sham stimulation conditions, as well as differences in functional connectivity in discrete cognitive networks on resting state fMRI. RESULTS Surgery and stimulation were well tolerated by all six patients (five male, mean age 71.33 years). One serious adverse event occurred: one patient developed antibiotic-associated colitis, prolonging his hospital stay by two weeks. No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients. Active stimulation was associated with functional connectivity changes in both the default mode network and the frontoparietal network. CONCLUSION Low frequency NBM DBS can be safely conducted in DLB patients. This should encourage further exploration of the possible effects of stimulation on neuropsychiatric symptoms and corresponding changes in functional connectivity in cognitive networks. TRIAL REGISTRATION NUMBER NCT02263937.",2020,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","['Dementia with Lewy bodies (DLB', 'Patients were aged between 50-80 years, had mild-moderate dementia symptoms and were living with a carer-informant', 'six DLB patients recruited from two UK neuroscience centres', 'DLB patients', 'six patients (five male, mean age 71.33 years']","['NBM DBS', 'Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation', 'image guided stereotactic implantation of bilateral DBS electrodes', 'active or sham stimulation', 'Meynert (NBM DBS']","['severity of neuropsychiatric symptoms', 'tolerated', 'safety and tolerability', 'functional connectivity in discrete cognitive networks on resting state fMRI', 'functional connectivity changes', 'Safety and tolerability', 'standardised measurements of cognitive, psychiatric and motor symptoms', 'antibiotic-associated colitis, prolonging his hospital stay']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",6.0,0.353614,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gratwicke', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: j.gratwicke@ucl.ac.uk.'}, {'ForeName': 'Ludvic', 'Initials': 'L', 'LastName': 'Zrinzo', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kahan', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Brechany', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNichol', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Beigi', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Harith', 'Initials': 'H', 'LastName': 'Akram', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyam', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Oswal', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Day', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mancini', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Yousry', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Crutch', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McKeith', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Schott', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Rossor', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: t.foltynie@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.04.010'] 166,31025714,Interventions for hand eczema.,"BACKGROUND Hand eczema is an inflammation of the skin of the hands that tends to run a chronic, relapsing course. This common condition is often associated with itch, social stigma, and impairment in employment. Many different interventions of unknown effectiveness are used to treat hand eczema. OBJECTIVES To assess the effects of topical and systemic interventions for hand eczema in adults and children. SEARCH METHODS We searched the following up to April 2018: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, AMED, LILACS, GREAT, and four trials registries. We checked the reference lists of included studies for further references to relevant trials. SELECTION CRITERIA We included randomised controlled trials (RCTs) that compared interventions for hand eczema, regardless of hand eczema type and other affected sites, versus no treatment, placebo, vehicle, or active treatments. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. Primary outcomes were participant- and investigator-rated good/excellent control of symptoms, and adverse events. MAIN RESULTS We included 60 RCTs, conducted in secondary care (5469 participants with mild to severe chronic hand eczema). Most participants were over 18 years old. The duration of treatment was short, generally up to four months. Only 24 studies included a follow-up period. Clinical heterogeneity in treatments and outcome measures was evident. Few studies performed head-to-head comparisons of different interventions. Risk of bias varied considerably, with only five studies at low risk in all domains. Twenty-two studies were industry-funded.Eighteen trials studied topical corticosteroids or calcineurin inhibitors; 10 studies, phototherapy; three studies, systemic immunosuppressives; and five studies, oral retinoids. Most studies compared an active intervention against no treatment, variants of the same medication, or placebo (or vehicle). Below, we present results from the main comparisons.Corticosteroid creams/ointments: when assessed 15 days after the start of treatment, clobetasol propionate 0.05% foam probably improves participant-rated control of symptoms compared to vehicle (risk ratio (RR) 2.32, 95% confidence interval (CI) 1.38 to 3.91; number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 8; 1 study, 125 participants); the effect of clobetasol compared to vehicle for investigator-rated improvement is less clear (RR 1.43, 95% CI 0.86 to 2.40). More participants had at least one adverse event with clobetasol (11/62 versus 5/63; RR 2.24, 95% CI 0.82 to 6.06), including application site burning/pruritus. This evidence was rated as moderate certainty.When assessed 36 weeks after the start of treatment, mometasone furoate cream used thrice weekly may slightly improve investigator-rated symptom control compared to twice weekly (RR 1.23, 95% CI 0.94 to 1.61; 1 study, 72 participants) after remission is reached. Participant-rated symptoms were not measured. Some mild atrophy was reported in both groups (RR 1.76, 95% CI 0.45 to 6.83; 5/35 versus 3/37). This evidence was rated as low certainty.Irradiation with ultraviolet (UV) light: local combination ultraviolet light therapy (PUVA) may lead to improvement in investigator-rated symptom control when compared to local narrow-band UVB after 12 weeks of treatment (RR 0.50, 95% CI 0.22 to 1.16; 1 study, 60 participants). However, the 95% CI indicates that PUVA might make little or no difference. Participant-rated symptoms were not measured. Adverse events (mainly erythema) were reported by 9/30 participants in the narrow-band UVB group versus none in the PUVA group. This evidence was rated as moderate certainty.Topical calcineurin inhibitors: tacrolimus 0.1% over two weeks probably improves investigator-rated symptom control measured after three weeks compared to vehicle (14/14 tacrolimus versus 0/14 vehicle; 1 study). Participant-rated symptoms were not measured. Four of 14 people in the tacrolimus group versus zero in the vehicle group had well-tolerated application site burning/itching.A within-participant study in 16 participants compared 0.1% tacrolimus to 0.1% mometasone furoate but did not measure investigator- or participant-rated symptoms. Both treatments were well tolerated when assessed at two weeks during four weeks of treatment.Evidence from these studies was rated as moderate certainty.Oral interventions: oral cyclosporin 3 mg/kg/d probably slightly improves investigator-rated (RR 1.88, 95% CI 0.88 to 3.99; 1 study, 34 participants) or participant-rated (RR 1.25, 95% CI 0.69 to 2.27) control of symptoms compared to topical betamethasone dipropionate 0.05% after six weeks of treatment. The risk of adverse events such as dizziness was similar between groups (up to 36 weeks; RR 1.22, 95% CI 0.80 to 1.86, n = 55; 15/27 betamethasone versus 19/28 cyclosporin). The evidence was rated as moderate certainty.Alitretinoin 10 mg improves investigator-rated symptom control compared with placebo (RR 1.58, 95% CI 1.20 to 2.07; NNTB 11, 95% CI 6.3 to 26.5; 2 studies, n = 781) and alitretinoin 30 mg also improves this outcome compared with placebo (RR 2.75, 95% CI 2.20 to 3.43; NNTB 4, 95% CI 3 to 5; 2 studies, n = 1210). Similar results were found for participant-rated symptom control: alitretinoin 10 mg RR 1.73 (95% CI 1.25 to 2.40) and 30 mg RR 2.75 (95% CI 2.18 to 3.48). Evidence was rated as high certainty. The number of adverse events (including headache) probably did not differ between alitretinoin 10 mg and placebo (RR 1.01, 95% CI 0.66 to 1.55; 1 study, n = 158; moderate-certainty evidence), but the risk of headache increased with alitretinoin 30 mg (RR 3.43, 95% CI 2.45 to 4.81; 2 studies, n = 1210; high-certainty evidence). Outcomes were assessed between 48 and 72 weeks. AUTHORS' CONCLUSIONS Most findings were from single studies with low precision, so they should be interpreted with caution. Topical corticosteroids and UV phototherapy were two of the major standard treatments, but evidence is insufficient to support one specific treatment over another. The effect of topical calcineurin inhibitors is not certain. Alitretinoin is more effective than placebo in controlling symptoms, but advantages over other treatments need evaluating.Well-designed and well-reported, long-term (more than three months), head-to-head studies comparing different treatments are needed. Consensus is required regarding the definition of hand eczema and its subtypes, and a standard severity scale should be established.The main limitation was heterogeneity between studies. Small sample size impacted our ability to detect differences between treatments.",2019,"Alitretinoin 10 mg improves investigator-rated symptom control compared with placebo (RR 1.58, 95% CI 1.20 to 2.07; NNTB 11, 95% CI 6.3 to 26.5; 2 studies, n = 781) and alitretinoin 30 mg also improves this outcome compared with placebo (RR 2.75, 95% CI 2.20 to 3.43; NNTB 4, 95% CI 3 to 5; 2 studies, n = 1210).","['More participants had at least one adverse event with clobetasol (11/62 versus 5/63', 'hand eczema in adults and children', 'Twenty-two studies were industry-funded', 'Most participants were over 18 years old', '5469 participants with mild to severe chronic hand eczema']","['PUVA', 'betamethasone', 'mometasone furoate cream', 'placebo', 'topical and systemic interventions', 'placebo, vehicle, or active treatments', 'Topical calcineurin inhibitors: tacrolimus', 'cyclosporin', 'Irradiation with ultraviolet (UV) light: local combination ultraviolet light therapy (PUVA', 'Alitretinoin', 'tacrolimus', 'topical betamethasone dipropionate', 'tacrolimus to 0.1% mometasone furoate', 'Corticosteroid creams/ointments', 'topical corticosteroids or calcineurin inhibitors', 'Topical corticosteroids and UV phototherapy', 'topical calcineurin inhibitors']","['Adverse events (mainly erythema', 'tolerated', 'number of adverse events (including headache', 'well-tolerated application site burning/itching', 'investigator-rated symptom control', 'investigator- or participant-rated symptoms', 'investigator-rated', 'risk of adverse events such as dizziness', 'risk of headache', 'mild atrophy', 'application site burning/pruritus', 'participant- and investigator-rated good/excellent control of symptoms, and adverse events']","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0239816', 'cui_str': 'Hand eczema (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1276092', 'cui_str': 'Chronic hand eczema'}]","[{'cui': 'C0853073', 'cui_str': 'PUVA'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet Light'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0041626', 'cui_str': 'Actinotherapy'}, {'cui': 'C0281666', 'cui_str': 'alitretinoin'}, {'cui': 'C0053523', 'cui_str': 'betamethasone dipropionate'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0877661', 'cui_str': 'Application site burn'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",5469.0,0.575728,"Alitretinoin 10 mg improves investigator-rated symptom control compared with placebo (RR 1.58, 95% CI 1.20 to 2.07; NNTB 11, 95% CI 6.3 to 26.5; 2 studies, n = 781) and alitretinoin 30 mg also improves this outcome compared with placebo (RR 2.75, 95% CI 2.20 to 3.43; NNTB 4, 95% CI 3 to 5; 2 studies, n = 1210).","[{'ForeName': 'Wietske Andrea', 'Initials': 'WA', 'LastName': 'Christoffers', 'Affiliation': 'Department of Dermatology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, Netherlands, 9700RB.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'Coenraads', 'Affiliation': ''}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Svensson', 'Affiliation': ''}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Diepgen', 'Affiliation': ''}, {'ForeName': 'Janine L', 'Initials': 'JL', 'LastName': 'Dickinson-Blok', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004055.pub2'] 167,32120028,Phase I randomized trial of liothyronine for remyelination in multiple sclerosis: A dose-ranging study with assessment of reliability of visual outcomes.,"BACKGROUND Thyroid hormone promotes remyelination in multiple sclerosis (MS) animal models through a variety of mechanisms. Liothyronine (L-T3) is a short-acting thyroid hormone with demonstrated safety and tolerability for short-term and chronic use in euthyroid adults with other health conditions, but has not been studied in people with MS. The objectives of this single-center, phase I, placebo-controlled, clinical trial were to determine the safety, tolerability, and optimal dosing of L-T3 in people with MS in preparation for a phase 2 remyelination clinical trial. Secondary goals included exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week. METHODS Groups of six clinically stable people with MS were randomized in a 4:2 ratio to receive L-T3 or placebo. The first group received 50 mcg total daily dose (TDD) of L-T3, with escalating doses of L-T3 in subsequent groups, up to potentially 150 mcg TDD in the final group. Prior to enrollment for the next dose-escalated group, all safety measures for the prior dose were reviewed. The maximum tolerated dose (MTD) was considered to be the dose below which two or more participants experienced dose limiting symptoms or one participant experienced a serious adverse event. After the MTD was reached, no further patients were enrolled. Visual evoked potentials (VEP) P100 latency with two different check sizes (17' and 34') and Sloan low contrast letter acuity (LCLA) were measured pre- and post-treatment. To determine whether there was a treatment effect, the placebo and L-T3 groups were compared using a clustered bootstrap regression estimation. A linear mixed effects model was used to determine test-retest reliability of VEP and LCLA in all eyes. RESULTS Between May 2016 and November 2016, 15 people with MS were randomized to L-T3 (n = 10) or placebo (n = 5). Subjects were adherent to the study drug and the MTD was 75 mcg TDD. No serious adverse events were observed and the most common adverse events were poor sleep and loose stools. No treatment effect of L-T3 was observed over one week. Therefore, data from patients on L-T3 and placebo were pooled to explore VEP and LCLA reliability. The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively. The mean differences in values between visits 1 and 2 for VEP 17' and 34' and LCLA were 1.9 ms/eye (SD 6.5), 0.4 ms/eye (6.3), and 0.8/eye (3.6), respectively. CONCLUSIONS This study confirms the short-term safety and tolerability of L-T3 in people with MS, with 75 mcg TDD as the MTD. Our results also support that, despite small variations over one week, VEP with various check sizes and Sloan LCLA are reliable functional and clinical outcome measures that could be used in remyelination clinical trials in MS. A future phase 2 clinical trial to investigate the efficacy of L-T3 as a remyelination therapy may be warranted. This trial was registered on clinicaltrials.gov (NCT02760056).",2020,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","['euthyroid adults with other health conditions', 'Groups of six clinically stable people with MS', 'people with MS in preparation for a phase 2 remyelination clinical trial', 'Between May 2016 and November 2016, 15 people with MS', 'people with MS, with 75 mcg TDD as the MTD', 'multiple sclerosis']","['Liothyronine (L-T3', '50 mcg total daily dose (TDD) of L-T3', 'L-T3', 'placebo', 'liothyronine', 'L-T3 or placebo']","['serious adverse events', 'Sloan low contrast letter acuity (LCLA', 'exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week', 'serious adverse event', 'Visual evoked potentials (VEP) P100 latency', 'VEP and LCLA reliability', 'safety and tolerability', 'maximum tolerated dose (MTD', 'safety, tolerability']","[{'cui': 'C0117002', 'cui_str': 'Euthyroid (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0334220', 'cui_str': 'Remyelination'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0042829', 'cui_str': 'Visual Pathways'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}]",15.0,0.117628,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Wooliscroft', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: wooliscr@ohsu.edu.'}, {'ForeName': 'Ghadah', 'Initials': 'G', 'LastName': 'Altowaijri', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: hildeand@ohsu.edu.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Samuels', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, CR107, Portland, OR 97239, United States. Electronic address: samuelsm@ohsu.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: oken@ohsu.edu.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Bourdette', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: bourdett@ohsu.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: cameromi@ohsu.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102015'] 168,32127336,Impact of body mass index on clinical outcome among elderly patients with acute coronary syndrome treated with percutaneous coronary intervention: Insights from the ELDERLY ACS 2 trial.,"BACKGROUND AND AIM Elderly patients are at increased risk of hemorrhagic and thrombotic complications after an acute coronary syndrome (ACS). Frailty, comorbidities and low body weight have emerged as conditioning the prognostic impact of dual antiplatelet therapy (DAPT). The aim of the present study was to investigate the prognostic impact of body mass index (BMI) on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study comparing low-dose (5 mg) prasugrel vs clopidogrel among elderly patients with ACS. METHODS AND RESULTS Our population is represented by 1408 patients enrolled in the Elderly-ACS 2 trial. BMI was calculated at admission. The primary endpoint of this analysis was cardiovascular (CV) mortality. Secondary endpoints were all-cause death, recurrent MI, Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding, and re-hospitalization for cardiovascular reasons or stent thrombosis within 12 months after index admission. Patients were grouped according to median values of BMI ( 50 mmol/l) in 14.9, 44.6 and 40.5% of the participants, respectively. There was a significant elevation in blood concentrations of 25(OH)D in both of the treatment arms (capsule p = 0.003, spray p = 0.001) compared with control. The capsule and spray were equally efficacious. The rate of change ranged from 0.69 to 3.93 (capsule) and 0.64 to 3.34 (spray) nmol/L day with average change in blood 25(OH)D levels of 2 nmol/l/day. Rates followed a simple normal distribution in the study population (ks = 0.94 and 0.82 for capsule and spray, respectively). The data suggest that rates of change are higher in individuals with lower levels of 25(OH)D. CONCLUSIONS A sublingual vitamin D spray is an effective mode of delivery for supplementation in a healthy population. The data provide reference values and ranges for the rate of change of 25(OH)D for nutrikinetic analyses.",2019,"There was a significant elevation in blood concentrations of 25(OH)D in both of the treatment arms (capsule p = 0.003, spray p = 0.001) compared with control.","['individuals with lower levels of 25(OH)D', 'healthy volunteers (n\u2009=\u200975']","['placebo', 'sublingual and capsular vitamin D preparations', 'sublingual vitamin D spray', 'vitamin D3 (3000\u2009IU/day) supplementation in capsule and sublingual spray preparations']","['Rate of change of circulating 25-hydroxyvitamin D', 'rate of change of vitamin D status', 'blood concentrations of 25(OH)D', '25(OH)D deficiency', 'Blood 25(OH)D concentrations', 'blood 25(OH)D levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1273658', 'cui_str': 'Sublingual spray'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.205393,"There was a significant elevation in blood concentrations of 25(OH)D in both of the treatment arms (capsule p = 0.003, spray p = 0.001) compared with control.","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Williams', 'Affiliation': 'Molecular Gastroenterology Research Group, Academic Unit of Surgical Oncology, Department of Oncology & Metabolism, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Williams', 'Affiliation': 'Department of Oncology & Metabolism, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Corfe', 'Affiliation': 'Molecular Gastroenterology Research Group, Academic Unit of Surgical Oncology, Department of Oncology & Metabolism, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK. b.m.corfe@sheffield.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0503-0'] 170,32325490,"Daratumumab, Lenalidomide, Bortezomib, & Dexamethasone for Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN.","Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). This study evaluated addition of daratumumab (D) to RVd in ASCT-eligible NDMM patients. Patients (N=207) were randomized 1:1 to receive RVd ±D induction (4 cycles), ASCT, RVd ±D consolidation (2 cycles), and lenalidomide ±D maintenance (26 cycles). At the primary endpoint analysis, the stringent complete response (sCR) rate by the end of post-ASCT consolidation favored D-RVd over RVd (42.4% vs 32.0%; odds ratio, 1.57; 95% confidence interval [CI], 0.87-2.82; 1-sided P=0.068) and met the prespecified 1-sided alpha of 0.10. With longer follow-up (median, 22.1 months), responses continued to deepen; rates of sCR improved for D-RVd versus RVd (62.6% vs 45.4%; P=0.0177), as did rates of minimal residual disease negativity (10-5 threshold) in the intent-to-treat population (51.0% vs 20.4%; P<0.0001). Four (3.8%) and 7 (6.8%) patients in the D-RVd and RVd groups progressed, respectively, and 24-month progression-free survival rates were 95.8% (D-RVd) and 89.8% (RVd). Grade 3/4 hematologic adverse events were more common with D-RVd. More infections occurred with D-RVd, but rates of grade 3/4 infections were similar. Median CD34+ cell yield was 8.2´106/kg for D-RVd and 9.4´106/kg for RVd, although plerixafor use was more common in the D-RVd arm. There was no difference in median times to neutrophil or platelet engraftment. In summary, daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. Clinicaltrials.gov NCT02874742.",2020,There was no difference in median times to neutrophil or platelet engraftment.,"['ASCT-eligible NDMM patients', 'patients with transplant-eligible NDMM', 'Patients (N=207', 'Transplant-eligible Newly Diagnosed Multiple Myeloma', 'transplant-eligible patients with newly diagnosed multiple myeloma (NDMM']","['RVd ±D induction (4 cycles), ASCT, RVd ±D consolidation (2 cycles), and lenalidomide ±D maintenance', 'Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT', 'Daratumumab, Lenalidomide, Bortezomib, & Dexamethasone', 'plerixafor']","['median times to neutrophil or platelet engraftment', 'stringent complete response (sCR) rate', 'Median CD34+ cell yield', 'depth of response', '24-month progression-free survival rates', 'Grade 3/4 hematologic adverse events', 'minimal residual disease negativity']","[{'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",207.0,0.136648,There was no difference in median times to neutrophil or platelet engraftment.,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina, United States.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Emory University Winship Cancer Institute, Atlanta, Georgia, United States.'}, {'ForeName': 'Jacob Peter', 'Initials': 'JP', 'LastName': 'Laubach', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts, United States.'}, {'ForeName': 'Douglas Weston', 'Initials': 'DW', 'LastName': 'Sborov', 'Affiliation': 'University of Utah -- Huntsman Cancer Institute, Salt Lake City, Utah, United States.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Mount Sinai Hospital, New York, New York, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Silbermann', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, United States.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'University of Alabama at Birmingham, Vestavia Hills, Alabama, United States.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Anderson', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, United States.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'City of Hope.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'University of California San Francisco, San Francisco, California, United States.'}, {'ForeName': 'Yvonne Adeduni', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Holstein', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Costello', 'Affiliation': 'UCSD, La Jolla, California, United States.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago, Chicago, Illinois, United States.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Wildes', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri, United States.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Shain', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cowan', 'Affiliation': 'University of Washington/Fred Hutchinson Cancer Research Center, Seattle, Washington, United States.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Murphy', 'Affiliation': 'Janssen, Spring House (Ambler), Pennsylvania, United States.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Lutska', 'Affiliation': 'Janssen Scientific Affairs, LLC.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Janssen, Titusville (Hopewell Township), New Jersey, United States.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Research & Development, LLC, Horsham, Pennsylvania, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'de Boer', 'Affiliation': 'Janssen Biologics, Leiden, Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hoehn', 'Affiliation': 'Janssen Scientific Affairs, Philadlephia, Pennsylvania, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Janssen Scientific Affairs, LLC.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, United States.'}]",Blood,['10.1182/blood.2020005288'] 171,32240186,"Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia.","BACKGROUND Youth-led strategies remain untested in clinic-based programs to improve viral suppression (VS) and reduce stigma among HIV-positive adolescents and young adults (AYA) in sub-Saharan Africa. In response, Project YES! placed paid HIV-positive youth peer mentors (YPM) in four HIV clinics in Ndola, Zambia including a Children's Hospital (pediatric setting), an adult Hospital and two primary care facilities (adult settings). METHODS A randomized controlled trial was conducted from December 2017 to February 2019. Consecutively recruited 15 to 24-year-olds were randomly assigned to an intervention arm with monthly YPM one-on-one and group sessions and optional caregiver support groups, or a usual care comparison arm. Survey data and blood samples were collected at baseline and at the six-month midline. Generalized estimating equation models evaluated the effect of study arm over time on VS, antiretroviral treatment (ART) adherence gap, and internalized stigma. RESULTS Out of 276 randomized youth, 273 were included in the analysis (Intervention n = 137, Comparison n = 136). VS significantly improved in both arms (I:63.5% to 73.0%; C:63.7% to 71.3.0%) [OR:1.49, 95% CI:1.08, 2.07]. In a stratified analysis intervention (I:37.5% to 70.5%) versus the comparison (C:60.3% to 59.4%) participants from the pediatric clinic experienced a relative increase in the odds of VS by a factor of 4.7 [interaction term OR:4.66, 95% CI:1.84, 11.78]. There was no evidence of a study arm difference in VS among AYA in adult clinics, or in ART adherence gaps across clinics. Internalized stigma significantly reduced by a factor of 0.39 [interaction term OR:0.39, 95% CI:0.21,0.73] in the intervention (50.4% to 25.4%) relative to the comparison arm (45.2% to 39.7%). CONCLUSIONS Project YES! engaged AYA, improving VS in the pediatric clinic and internalized stigma in the pediatric and adult clinics. Further research is needed to understand the intersection of VS and internalized stigma among AYA attending adult HIV clinics. TRIAL REGISTRATION ClinicalTrials.gov NCT04115813.",2020,Internalized stigma significantly reduced by a factor of 0.39,"['Youth Engaging for Success', 'HIV-positive youth (15-24 years) in Ndola, Zambia', 'December 2017 to February 2019', ""HIV-positive youth peer mentors (YPM) in four HIV clinics in Ndola, Zambia including a Children's Hospital (pediatric setting), an adult Hospital and two primary care facilities (adult settings"", '276 randomized youth, 273 were included in the analysis (Intervention n = 137, Comparison n = 136', 'HIV-positive adolescents and young adults (AYA) in sub-Saharan Africa', 'Consecutively recruited 15 to 24-year-olds']","['intervention arm with monthly YPM one-on-one and group sessions and optional caregiver support groups, or a usual care comparison arm', 'clinic-based peer mentoring program']","['viral suppression, adherence and internalized stigma', 'Internalized stigma']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",276.0,0.223527,Internalized stigma significantly reduced by a factor of 0.39,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Denison', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Burke', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Miti', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}, {'ForeName': 'Bareng A S', 'Initials': 'BAS', 'LastName': 'Nonyane', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Frimpong', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}, {'ForeName': 'Katherine G', 'Initials': 'KG', 'LastName': 'Merrill', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Abrams', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Mwansa', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}]",PloS one,['10.1371/journal.pone.0230703'] 172,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. METHODS We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first. RESULTS A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events. CONCLUSIONS In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282'] 173,32277253,Prognostic role of thrombocytosis in recurrent ovarian cancer: a pooled analysis of the AGO Study Group.,"PURPOSE Although thrombocytosis in patients with primary ovarian cancer has been widely investigated, there are only very few data about the role of thrombocytosis in recurrent ovarian cancer. The aim of our study was to investigate the impact of pretreatment thrombocytosis prior to chemotherapy on clinical outcome in patients with recurrent platinum eligible ovarian cancer. METHODS In our retrospective analysis we included 300 patients who were treated by AGO Study Group Centers within three prospective, randomized phase-III-trials. All patients included had been treatment-free for at least 6 months after platinum-based chemotherapy. We excluded patients who underwent secondary cytoreductive surgery before randomization to the trial. Thrombocytosis was defined as a platelet count of ≥ 400⋅10 9 /L. RESULTS Pretreatment thrombocytosis was present in 37 out of 300 (12.3%) patients. Patients with thrombocytosis responded statistically significantly less to chemotherapy (overall response rate 35.3% and 41.6%, P = 0.046). The median progression-free survival (PFS) for patients with thrombocytosis was 6.36 months compared to 9.00 months for patients without thrombocytosis (hazard ratio [HR] = 1.19, 95% confidence interval [CI] = 0.84-1.69, P = 0.336). Median overall survival (OS) of patients with thrombocytosis was 16.33 months compared to 23.92 months of patients with a normal platelet count (HR = 1.46, 95% CI = 1.00-2.14, P = 0.047). CONCLUSIONS The present analysis suggests that pretreatment thrombocytosis is associated with unfavorable outcome with regard to response to chemotherapy and overall survival in recurrent ovarian cancer.",2020,"Median overall survival (OS) of patients with thrombocytosis was 16.33 months compared to 23.92 months of patients with a normal platelet count (HR = 1.46, 95% CI = 1.00-2.14, P = 0.047). ","['patients who underwent secondary cytoreductive surgery before randomization to the trial', 'patients with primary ovarian cancer', '300 patients who were treated by AGO Study Group Centers within three prospective, randomized phase-III-trials', 'All patients included had been treatment-free for at least 6\xa0months after platinum-based chemotherapy', 'recurrent ovarian cancer', 'patients with recurrent platinum eligible ovarian cancer']",['chemotherapy'],"['Thrombocytosis', 'Median overall survival (OS) of patients with thrombocytosis', 'median progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0836924', 'cui_str': 'Thrombocytosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",300.0,0.118376,"Median overall survival (OS) of patients with thrombocytosis was 16.33 months compared to 23.92 months of patients with a normal platelet count (HR = 1.46, 95% CI = 1.00-2.14, P = 0.047). ","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany. ulrich.canzler@uniklinikum-dresden.de.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lück', 'Affiliation': 'Gynecologic Oncology, Gyn-Onko Hannover, Hanover, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Neuser', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department for Gynecology and Center for Oncological Surgery, Charité, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Burges', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Essen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum rechts der Isar München, Munich, Germany.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Aminossadati', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kommoss', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Wimberger', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Pfisterer', 'Affiliation': 'Department of Gynecology and Obstetrics, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, University Hospital Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gropp-Meier', 'Affiliation': 'Department of Gynecology and Obstetrics, Oberschwabenklinik, Krankenhaus St. Elisabeth, Ravensburg, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Balat', 'Affiliation': 'Department of Gynecology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Department of Obstetrics and Gynecology, Sana Klinikum Offenbach GmbH, Offenbach, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Essen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wagner', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg, Marburg, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05529-y'] 174,31826336,"Early High-Dose Vitamin D 3 for Critically Ill, Vitamin D-Deficient Patients.","BACKGROUND Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study. METHODS We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D 3 supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D 3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality. RESULTS A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, -2.1 to 7.9; P = 0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality. CONCLUSIONS Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients. (Funded by the National Heart, Lung, and Blood Institute; VIOLET ClinicalTrials.gov number, NCT03096314.).",2019,"Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","['critically ill, vitamin D-deficient patients who were at high risk for death', 'Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population', '1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization', 'critically ill, vitamin D-deficient patients', 'Critically Ill, Vitamin D-Deficient Patients', 'critically ill patients']","['single enteral dose of 540,000 IU of vitamin D 3 or matched placebo', 'vitamin D supplementation', 'placebo', 'early vitamin D 3 supplementation', 'vitamin D']","['90-day mortality', '90-day mortality or other, nonfatal outcomes', '90-day all-cause, all-location mortality', 'mean day 3 level of 25-hydroxyvitamin D', 'severity of vitamin D deficiency']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",1360.0,0.763031,"Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Caterino', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Finck', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Colin K', 'Initials': 'CK', 'LastName': 'Grissom', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayden', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hyzy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Levitt', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ringwood', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Emanuel P', 'Initials': 'EP', 'LastName': 'Rivers', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}]",The New England journal of medicine,['10.1056/NEJMoa1911124'] 175,31338998,"Weight Loss Experiences of African American, Hispanic, and Non-Hispanic White Men and Women with Type 2 Diabetes: The Look AHEAD Trial.","OBJECTIVE The aim of this study was to characterize weight loss, treatment engagement, and weight control strategies utilized by African American, Hispanic, and non-Hispanic white participants in the Action for Health in Diabetes (Look AHEAD) Intensive Lifestyle Intervention by racial/ethnic and sex subgroups. METHODS Weight losses at 1, 4, and 8 years among 2,361 adults with obesity and type 2 diabetes randomized to intervention (31% minority; 42% men) are reported by subgroup. Multivariable models within subgroups examine relative contributions of treatment engagement variables and self-reported weight control behaviors. RESULTS All subgroups averaged weight losses ≥ 5% in year 1 but experienced regain; losses ≥ 5% were sustained at year 8 by non-Hispanic white participants and minority women (but not men). Session attendance was high (≥ 86%) in year 1 and exceeded protocol-specified minimum levels into year 8. Individual session attendance had stronger associations with weight loss among Hispanic and African American participants than non-Hispanic white participants at 4 years (P = 0.04) and 8 years (P = 0.001). Daily self-weighing uptake was considerable in all subgroups and was a prominent factor associated with year 1 weight loss among African American men and women. Greater meal replacement use was strongly associated with poorer 1-year weight losses among African American women. CONCLUSIONS Experiences of minority men and women with diabetes in lifestyle interventions fill important gaps in the literature that can inform treatment delivery.",2019,Daily self-weighing uptake was considerable in all subgroups and was a prominent factor associated with year 1 weight loss among African American men and women.,"['Weight losses at 1, 4, and 8 years among 2,361 adults with obesity and type 2 diabetes randomized to intervention (31% minority; 42% men', 'Weight Loss Experiences of African American, Hispanic, and Non-Hispanic White Men and Women with Type 2 Diabetes', 'African American women', 'African American men and women', 'African American, Hispanic, and non-Hispanic white participants in the Action for Health in Diabetes ']",['Intensive Lifestyle Intervention'],"['Daily self-weighing uptake', 'Session attendance', '1-year weight losses', 'weight loss']","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",2361.0,0.027542,Daily self-weighing uptake was considerable in all subgroups and was a prominent factor associated with year 1 weight loss among African American men and women.,"[{'ForeName': 'Delia Smith', 'Initials': 'DS', 'LastName': 'West', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Dutton', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Diabetes Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Rickman', 'Affiliation': 'Department of Exercise & Rehabilitative Sciences, Slippery Rock University, Slippery Rock, Pennsylvania, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, NIDDK, Phoenix, Arizona, USA.'}, {'ForeName': 'Mara Z', 'Initials': 'MZ', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Gee', 'Affiliation': 'Behavioral Medicine Research Center, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cassidy Begay', 'Affiliation': 'NIDDK and Indian Health Service, Shiprock, New Mexico, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22522'] 176,31685553,"Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W).","OBJECTIVES To investigate the efficacy and safety of ixekizumab for up to 52 weeks in two phase 3 studies of patients with active radiographic axial spondyloarthritis (r-axSpA) who were biological disease-modifying antirheumatic drug (bDMARD)-naive (COAST-V) or tumour necrosis factor inhibitor (TNFi)-experienced (COAST-W). METHODS Adults with active r-axSpA were randomised 1:1:1:1 (n=341) to 80 mg ixekizumab every 2 (IXE Q2W) or 4 weeks (IXE Q4W), placebo (PBO) or 40 mg adalimumab Q2W (ADA) in COAST-V and 1:1:1 (n=316) to IXE Q2W, IXE Q4W or PBO in COAST-W. At week 16, patients receiving ixekizumab continued their assigned treatment; patients receiving PBO or ADA were rerandomised 1:1 to IXE Q2W or IXE Q4W (PBO/IXE, ADA/IXE) through week 52. RESULTS In COAST-V, Assessment of SpondyloArthritis international Society 40 (ASAS40) responses rates (intent-to-treat population, non-responder imputation) at weeks 16 and 52 were 48% and 53% (IXE Q4W); 52% and 51% (IXE Q2W); 36% and 51% (ADA/IXE); 19% and 47% (PBO/IXE). Corresponding ASAS40 response rates in COAST-W were 25% and 34% (IXE Q4W); 31% and 31% (IXE Q2W); 14% and 39% (PBO/IXE). Both ixekizumab regimens sustained improvements in disease activity, physical function, objective markers of inflammation, QoL, health status and overall function up to 52 weeks. Safety through 52 weeks of ixekizumab was consistent with safety through 16 weeks. CONCLUSION The significant efficacy demonstrated with ixekizumab at week 16 was sustained for up to 52 weeks in bDMARD-naive and TNFi-experienced patients. bDMARD-naive patients initially treated with ADA demonstrated further numerical improvements after switching to ixekizumab. Safety findings were consistent with the known safety profile of ixekizumab. TRIAL REGISTRATION NUMBER NCT02696785/NCT02696798.",2020,"Both ixekizumab regimens sustained improvements in disease activity, physical function, objective markers of inflammation, QoL, health status and overall function up to 52 weeks.","['patients with active radiographic axial spondyloarthritis (r-axSpA) who were biological disease-modifying antirheumatic drug (bDMARD)-naive (COAST-V) or tumour necrosis factor inhibitor (TNFi)-experienced (COAST-W', 'patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W', 'Adults with active r-axSpA']","['ADA', 'Corresponding ASAS40', 'IXE Q2W, IXE Q4W or PBO in COAST-W', 'ixekizumab', 'IXE Q2W or IXE Q4W (PBO/IXE, ADA/IXE', 'ixekizumab every 2 (IXE Q2W) or 4 weeks (IXE Q4W), placebo (PBO) or 40 mg adalimumab Q2W (ADA', 'PBO or ADA']","['disease activity, physical function, objective markers of inflammation, QoL, health status and overall function', 'efficacy and safety', 'response rates', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.11682,"Both ixekizumab regimens sustained improvements in disease activity, physical function, objective markers of inflammation, QoL, health status and overall function up to 52 weeks.","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Paris Descartes University; Department of Rheumatology, Hôpital Cochin; Assistance Publique - Hôpitaux de Paris; INSERM (U1153), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France maxime.dougados@aphp.fr.'}, {'ForeName': 'James Cheng-Chung', 'Initials': 'JC', 'LastName': 'Wei', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University; Department of Internal Medicine, Chung Shan Medical University Hospital; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam Rheumatology and Clinical Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Sieper', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Van den Bosch', 'Affiliation': 'Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Maksymowych', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Ermann', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'Division of Rheumatology, University of Utah and Salt Lake City Veterans Affairs Medical Centers, Salt Lake City, Utah, USA.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tomita', 'Affiliation': 'Department of Orthopaedic Biomaterial Science, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Clinton C', 'Initials': 'CC', 'LastName': 'Bertram', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Carlier', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216118'] 177,32328912,Effects of a Decision-Making Intervention to Help Decide Whether to Disclose HIV-Positive Status to Family Members on Well-Being and Sexual Behavior.,"An HIV diagnosis is often followed by uncertainty, questions over next steps, and concerns over how to share the diagnosis with others. The goal of the current study was to investigate the effects of an intervention designed to help people living with HIV decide whether or not they want to disclose their status to family members (i.e., decision-making process rather than actual disclosure) and the subsequent decision on their well-being and sexual behavior. Additionally, differences in outcomes among men who have sex with men (MSM), heterosexual men (HSM), and women were examined. A total of 346 women and men living in the Southeastern part of the United States. Participated in the study, which consisted of a baseline assessment, followed by randomization into either the disclosure intervention or attention control case management group. Both treatments consisted of seven sessions over a 12-month period. Results from repeated measures ANOVA indicated that although there was no significant intervention effect, participants in both groups reported some improvements in well-being and decreases in risky sexual behavior. However, no consistent differences in outcomes emerged among MSM, HSM, and women. Assisting with the disclosure decision-making process and reducing HIV transmission risk should continue to be an essential focus in future research endeavors and for frontline professionals dedicated to HIV-related care and prevention.",2020,"Results from repeated measures ANOVA indicated that although there was no significant intervention effect, participants in both groups reported some improvements in well-being and decreases in risky sexual behavior.","['346 women and men living in the Southeastern part of the United States', 'men who have sex with men (MSM), heterosexual men (HSM), and women were examined']","['Decision-Making Intervention', 'disclosure intervention or attention control case management group']",['risky sexual behavior'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",346.0,0.0273878,"Results from repeated measures ANOVA indicated that although there was no significant intervention effect, participants in both groups reported some improvements in well-being and decreases in risky sexual behavior.","[{'ForeName': 'Julianne M', 'Initials': 'JM', 'LastName': 'Serovich', 'Affiliation': 'College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, 33612, USA. jserovich@usf.edu.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Laschober', 'Affiliation': 'College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, 33612, USA.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Kimberly', 'Affiliation': 'Division of Biology and Medicine, Brown University, Providence, RI, USA.'}, {'ForeName': 'Celia M', 'Initials': 'CM', 'LastName': 'Lescano', 'Affiliation': 'Department of Mental Health Law and Policy, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.'}]",Archives of sexual behavior,['10.1007/s10508-020-01703-0'] 178,32274634,GM-CSF does not rescue poor-quality embryos: secondary analysis of a randomized controlled trial.,"PURPOSE To evaluate implantation potential of cleavage-stage embryos cultured in medium containing 2 ng/ml granulocyte-macrophage colony-stimulating factor (GM-CSF) versus control medium, according to embryo morphological quality and then transferred on day 3. METHODS Explorative secondary data analysis of a multicenter, randomized, placebo-controlled, double-blinded prospective study of 1149 couples with embryo transfer after IVF/ICSI. This analysis includes a subgroup of 422 subjects with either single-embryo transfer (SET, N = 286) or double-embryo transfer of two embryos with equivalent morphological quality (DET, N = 136). Implantation rate and live birth rate were assessed according to category of morphological embryo quality on day 3. RESULTS Culture with GM-CSF did not increase the implantation rate for embryos classified as poor quality. A trend towards greater benefit of GM-CSF on implantation and survival until live birth for top-quality embryos (TQEs) compared with poor-quality embryos was observed, although not statistically significant. For TQEs, the percentage of transferred embryos resulting in a live born baby was: 40.9 ± 5.3% (GM-CSF) versus 30.5 ± 4.6% (control) (P = 0.24; odds ratio [OR] 1.43, 95% confidence interval [CI] 0.79-2.59), and for embryos with less than 6 cells at day 3 this same rate was: 7.4 ± 3.3% (GM-CSF) versus 12.0 ± 4.0% (control) (P = 0.26; OR 0.53, 95% CI 0.17-1.61). CONCLUSION This exploratory analysis is consistent with GM-CSF protecting morphologically normal embryos from culture-induced stress and does not support an effect of GM-CSF in rescuing poor-quality embryos. ClinicalTrials.gov identifier: NCT00565747.",2020,"RESULTS Culture with GM-CSF did not increase the implantation rate for embryos classified as poor quality.","['422 subjects with either single-embryo transfer (SET, N\u2009=\u2009286) or double-embryo transfer of two embryos with equivalent morphological quality (DET, N\u2009=\u2009136', '1149 couples with embryo transfer after IVF/ICSI']","['GM-CSF', 'placebo', 'cleavage-stage embryos cultured in medium containing 2\xa0ng/ml granulocyte-macrophage colony-stimulating factor (GM-CSF) versus control medium']","['implantation rate', 'implantation and survival until live birth', 'Implantation rate and live birth rate']","[{'cui': 'C2717901', 'cui_str': 'Single Embryo Transfer'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011134', 'cui_str': 'diethyltoluamide'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0920489', 'cui_str': 'Culture of embryo'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",1149.0,0.414578,"RESULTS Culture with GM-CSF did not increase the implantation rate for embryos classified as poor quality.","[{'ForeName': 'Kenny A', 'Initials': 'KA', 'LastName': 'Rodriguez-Wallberg', 'Affiliation': 'Division of Gynecology and Reproduction, Department of Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden. kenny.rodriguez-wallberg@sll.se.'}, {'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Munding', 'Affiliation': 'CooperSurgical, ORIGIO a/S, Måløv, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Ziebe', 'Affiliation': 'The Fertility Clinic, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Robertson', 'Affiliation': 'Robinson Research Institute, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05532-3'] 179,32328709,"Correction to: A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.","The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.",2020,"The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.",[],"['drospirenone-only pill 4\xa0mg over nine cycles in comparison with desogestrel 0.075\xa0mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor', 'desogestrel 0.075\xa0mg', 'drospirenone']",[],[],"[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1306692', 'cui_str': 'Desogestrel 0.075 MG'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",[],,0.264965,"The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Instituto Palacios, Salud Y Medicina de La Mujer, C/Antonio Acuña, 28009, Madrid, Spain.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, C/ Manuel Pombo Angulo 28, 4th Floor, 28050, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Adalperostr. 84, 85737, Ismaning, Germany. pedro-antonio.regidor@exeltis.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05544-z'] 180,32329986,Transcranial magnetic stimulation over the right temporoparietal junction influences the sense of agency in healthy humans.,"Background The sense of agency is an important aspect of motor control. Impaired sense of agency has been linked to several medical conditions, including schizophrenia and functional neurological disorders. A complex brain network subserves the sense of agency, and the right temporoparietal junction is one of its main nodes. In this paper, we tested whether transcranial magnetic stimulation over the right temporoparietal junction elicited behavioural changes in the sense of agency. Methods In experiment 1, 15 healthy participants performed a behavioural task during functional MRI, with the goal of localizing the area relevant for the sense of agency in the right temporoparietal junction. In the task, the movement of a cursor (controlled by the participants) was artificially manipulated, and the sense of agency was either diminished (turbulence) or enhanced (magic). In experiment 2, we applied transcranial magnetic stimulation in 20 healthy participants in a sham-controlled, crossover trial with excitatory, inhibitory or sham (vertex) stimulation. We measured the summary agency score, an indicator of the sense of agency (lower values correspond to diminished sense of agency). Results Experiment 1 revealed a peak of activation during agency manipulation in the right temporoparietal junction (Montreal Neurological Institute coordinates x, y, z: 68, -26, 34). Experiment 2 showed that inhibition of the right temporoparietal junction significantly reduced the summary agency score in both turbulence (from -14.4 ± 11.4% to -22.5 ± 8.9%), and magic (from -0.7 ± 5.8% to -4.4 ± 4.4%). Limitations We found no excitatory effects, possibly because of a ceiling effect (because healthy participants have a normal sense of agency) or noneffectiveness of the excitatory protocol. Conclusion Our experiments showed that the network subserving the sense of agency was amenable to neuromodulation in healthy participants. This sets the ground for further research in patients with impaired sense of agency. Clinical trial identification: DRKS00012992 (German clinical trials registry).",2020,"We found no excitatory effects, possibly because of a ceiling effect (because healthy participants have a normal sense of agency) or noneffectiveness of the excitatory protocol. ","['15 healthy participants', 'patients with impaired sense of agency', '20 healthy participants', 'healthy participants', 'healthy humans']","['excitatory, inhibitory or sham (vertex) stimulation', 'Transcranial magnetic stimulation', 'transcranial magnetic stimulation']","['inhibition of the right temporoparietal junction', 'summary agency score']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0370275,"We found no excitatory effects, possibly because of a ceiling effect (because healthy participants have a normal sense of agency) or noneffectiveness of the excitatory protocol. ","[{'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Zito', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Anderegg', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Kallia', 'Initials': 'K', 'LastName': 'Apazoglou', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Müri', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Martin Grosse', 'Initials': 'MG', 'LastName': 'Holtforth', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Aybek', 'Affiliation': 'From the Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Anderegg, Müri, Holtforth, Aybek); the Support Centre for Advanced Neuroimaging (SCAN), University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (Zito, Wiest); Department of Neuroscience, Faculty of Medicine, University of Geneva, Switzerland (Apazoglou); the Perception and Eye Movement Laboratory, Department of Neurology and Biomedical Research, Inselspital, Bern University Hospital, University of Bern, Switzerland (Müri); and the Institute of Psychology, University of Bern, Bern, Switzerland (Holtforth).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190099'] 181,32330093,Increasing standing tolerance in office workers with standing-induced back pain.,"Sit-stand desks are popular however many people have standing-induced low back pain (LBP). People with LBP have fewer standing weight shifts compared with back-healthy people. Participants were classified as standing-tolerant or intolerant. Participants were provided sit-stand desks for 12 weeks. Participants were assigned to intervention (graded standing exposure and exercise) or control (no instruction) conditions. Participants reported weekly sitting time and average/worst LBP. Standing weight shifts and LBP were re-assessed post-intervention. All groups decreased sitting time (range: 30-50%) over 12 weeks. Sitting time and average LBP were correlated in all standing-intolerant individuals, worst LBP and sitting time were correlated for intervention group only. All standing-intolerant individuals increased standing weight shifts and decreased LBP after 12-weeks. Standing-intolerant individuals benefitted from 12-weeks of sit-stand desk use regardless of intervention. Motivated individuals with standing-induced LBP may increase standing tolerance with sit-stand desk use. Additional benefits may exist when structured guidance is provided. Practitioner summary: Many people are standing-intolerant due to low back pain (LBP). This lab and field-based study showed some benefits from structured approaches to gradually progress standing time when transitioning to standing work. Using a sit-stand desk for 12 weeks resulted in decreased LBP and sitting time in standing-intolerant people. Abbreviations: LBP: low back pain; OSPAQ: Occupational Sitting and Physical Activity Questionnaire; VAS: visual analog scale; GRF: ground reaction force; WeekVASMAX: worst low back pain reported on visual analog scale for prior week; WeekVASAVE: average low back pain reported on visual analog scale for prior week; ICC: intraclass correlation coefficient; LabVASMAX: worst low back pain reported on visual analog scale during lab-based standing; LabVASAVE: average low back pain reported on visual analog scale during lab-based standing; FvR,L: vertical ground reaction force for right and left force plate; BWSSMALL: small (10-29% body weight) body weight shift; BWSLARGE: large (> 30% body weight) body weight shift; ActivPALSED: ActivePAL data for sedentary time; ActivPALSTND: ActivePAL data for standing time; ANOVA: analysis of variance; Standing Intolerant-INT: standing intolerant participants assigned to intervention condition; Standing Intolerant-CON: standing intolerant participants assigned to control condition; Standing Tolerant-INT: standing tolerant participants assigned to intervention condition; Standing Tolerant-CON: standing tolerant participants assigned to control condition; SI: standing intolerant; ST: standing tolerant; INT: intervention; CON: control.",2020,Using a sit-stand desk for 12 weeks resulted in decreased LBP and sitting time in standing-intolerant people.,['office workers with standing-induced back pain'],"['LBP', 'intervention (graded standing exposure and exercise) or control (no instruction) conditions']","['Sitting time and average LBP', 'Standing weight shifts and LBP', 'sitting time', 'weekly sitting time and average/worst LBP', 'standing tolerance', 'LBP and sitting time', 'standing weight shifts and decreased LBP', 'standing weight shifts']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0589035', 'cui_str': 'Standing tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0292197,Using a sit-stand desk for 12 weeks resulted in decreased LBP and sitting time in standing-intolerant people.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nelson-Wong', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Gallagher', 'Affiliation': 'College of Education and Health Professions, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Antonioli', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ferguson', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'James Blake', 'Initials': 'JB', 'LastName': 'Miller', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}]",Ergonomics,['10.1080/00140139.2020.1761034'] 182,32325257,"A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer.","BACKGROUND The optimal duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer patients is unknown, with 5, 7 or 10 days being commonly prescribed. This trial evaluates whether 5 days of filgrastim was non-inferior to 7/10 days. PATIENTS AND METHODS In this randomised, open-label trial, early breast cancer patients who were to receive filgrastim as primary FN prophylaxis were randomly allocated to 5 versus 7 versus 10 days of filgrastim for all chemotherapy cycles. A protocol amendment in November 2017 allowed subsequent patients (N = 324) to be randomised to either 5 or 7/10 days. The primary outcome was a composite of either FN or treatment-related hospitalisations. Secondary outcomes included chemotherapy dose reductions, delays and discontinuations. Analyses were carried out by per protocol (primary) and intention-to-treat, and the non-inferiority margin was set at 3% for the risk of having FN and/or hospitalisation per cycle of chemotherapy. RESULTS Patients (N = 466) were randomised to receive 5 (184, 39.5%), or 7/10 (282, 60.5%) days of filgrastim. In our primary analysis, the difference in risk of either FN or treatment-related hospitalisation per cycle was -1.52% [95% confidence interval (CI): -3.22% to 0.19%] suggesting non-inferiority of a 5-day filgrastim schedule compared with 7/10-days. The difference in events per cycle for FN was 0.11% (95% CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95% CI: -2.73% to -0.63%). The overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalisation were 11.8% and 14.96% for the 5- and 7/10-day groups, respectively (risk difference: -3.17%, 95% CI: -9.51% to 3.18%). CONCLUSION Five days of filgrastim was non-inferior to 7/10 days. Given the cost and toxicity of this agent, 5 days should be considered standard of care. CLINICALTRIALS. GOV REGISTRATION NCT02428114 and NCT02816164.",2020,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"['early breast cancer (EBC) patients', 'Patient (N=466', 'November 2017 allowed subsequent patients (N=324', 'early stage breast cancer', 'EBC patients who were to receive filgrastim as primary FN prophylaxis']","['filgrastim', 'G-CSF (filgrastim']","['overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalization', 'risk of either FN or treatment-related hospitalisation per cycle', 'events per cycle for FN', 'composite of either FN or treatment-related hospitalisations', 'chemotherapy dose reductions, delays, and discontinuations', 'febrile neutropenia']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.248534,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mclemons@toh.ca.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Simos', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Califaretti', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zibdawi', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahl', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raphael', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada; Division of Medical Oncology, London Regional Cancer Program, Western University, London, Canada.'}, {'ForeName': 'M F K', 'Initials': 'MFK', 'LastName': 'Ibrahim', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fernandes', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pitre', 'Affiliation': 'The Northeast Cancer Centre, Sudbury, Canada.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Aseyev', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Pond', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Awan', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.005'] 183,32084347,Therapeutic Effects of Exercise Training on Elderly Patients With Dementia: A Randomized Controlled Trial.,"OBJECTIVE To investigate whether strength or aerobic training can offer significantly more benefits with regarding the activities of daily living of elderly patients with dementia as well as to determine the effects of exercise on cognition, depression, and biochemical markers. DESIGN Single-blind randomized controlled trial. SETTING A nursing home for veterans. PARTICIPANTS A volunteer sample of participants (N=80) whose scores on the Mini-Mental State Examination were between 15 and 26 were included. Because of cardiopulmonary or orthopedic conditions that prohibit exercise training, along with any cognitive problems that may impede answering the contents of our questionnaires, 11 participants were excluded. During the exercise training period, 8 participants voluntarily dropped out of the study. INTERVENTIONS The participants were randomly assigned to perform either strength or aerobic training for a total of 4 weeks. MAIN OUTCOME MEASURES The main outcome measure was the Barthel Index. Other outcome measures included the Mini-Mental State Examination, Montreal Cognitive Assessment, Geriatric Depression Scale, plasma monocyte chemotactic protein-1 levels, insulin-like growth factor-1 levels, and serum brain-derived neurotrophic factor levels. RESULTS After completion of the program, we discovered a significant improvement in the patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels in the strength-training group. For the patients who had received aerobic training, their serum brain-derived neurotrophic factor also improved significantly. However, the degree of improvement regarding these outcome measures did not achieve significant statistical difference between the 2 groups. CONCLUSIONS Through our study, an intensive 4-week exercise program, whether it be strength or aerobic training, is evidenced to bring significant benefits to elderly patients with dementia, while the serum brain-derived neurotrophic factor was additionally improved through aerobic training.",2020,"After completion of the program, we discovered a significant improvement in the patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels in the strength-training group.","['Elderly Patients with Dementia', 'elderly patients with dementia', 'A volunteer sample of 80 participants whose scores on the Mini-Mental State Examination were between 15 and 26 were included']","['Exercise Training', 'aerobic training', 'prohibit exercise training', 'strength or aerobic training']","['Mini-Mental State Examination, Montreal Cognitive Assessment, Geriatric Depression Scale, plasma monocyte chemotactic protein-1 levels, insulin-like growth factor-1 levels, and serum brain-derived neurotrophic factor levels', 'serum brain-derived neurotrophic factor', ""patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels"", 'Barthel Index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C3496286'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}]",11.0,0.146852,"After completion of the program, we discovered a significant improvement in the patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels in the strength-training group.","[{'ForeName': 'I-Ting', 'Initials': 'IT', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Wei-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Shih-Yi', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Shin-Tsu', 'Initials': 'ST', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, Taichung, Taiwan; Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taipei, Taiwan; School of Medicine, National Defense Medical Center, Taipei, Taiwan; School of Medicine, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chung-Lan', 'Initials': 'CL', 'LastName': 'Kao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yuan-Yang', 'Initials': 'YY', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, Taichung, Taiwan; Center for Geriatrics and Gerontology, Taichung Veterans General Hospital, Taichung, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan. Electronic address: rifampin@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.01.012'] 184,32329184,Influence of sildenafil on esophageal motor function in humans: Studies using high-resolution manometry.,"BACKGROUND/AIM Sildenafil induces smooth muscle relaxation of the esophagus by blocking type 5 phosphodiesterase that degrades cyclic guanine monophosphate. We aimed to characterize the effects of sildenafil on esophageal peristalsis and contraction reserve using high-resolution manometry (HRM). METHODS Fifteen healthy adults (12 men, age 21-39, mean 27 years) participated in this study using HRM following either sildenafil 50 mg or placebo. HRM with ten wet swallows and five multiple rapid swallows was performed in all participants. HRM metrics included esophagogastric junction contractile integral (EGJ-CI), basal lower esophageal sphincter (LES) pressure, 4-second integrated relaxation pressure (IRP-4s), distal contractile integral (DCI), distal latency, resting upper esophageal sphincter pressure (UESP), and the response to MRS. RESULTS Sildenafil significantly lowered EGJ-CI (P < .001), LES pressure (P = .04), IRP-4s (P = .02), and DCI (P < .001). There was no difference in UESP (P = .87) between sildenafil and placebo. Sildenafil significantly decreased peristaltic vigor, inducing absent peristalsis in 12 subjects and ineffective esophageal motility in 3 subjects. Peristaltic response and augmentation following MRS were significantly inhibited following sildenafil (7% vs 100%, P < .001, and none vs 73%, P < .001). CONCLUSIONS Sildenafil attenuates EGJ barrier function, resting LES pressure, and LES relaxation. Both esophageal body contractility and contraction reserve are inhibited by sildenafil in healthy adults.",2020,"RESULTS Sildenafil significantly lowered EGJ-CI (P < .001), LES pressure (P = .04), IRP-4s (P = .02), and DCI (P < .001).","['humans', 'healthy adults', 'Fifteen healthy adults (12 men, age 21-39, mean 27\xa0years']","['placebo', 'sildenafil', 'sildenafil 50\xa0mg or placebo', 'Sildenafil']","['LES pressure', 'Peristaltic response and augmentation following MRS', 'UESP', 'EGJ barrier function, resting LES pressure, and LES relaxation', 'peristaltic vigor', 'DCI', 'esophagogastric junction contractile integral (EGJ-CI), basal lower esophageal sphincter (LES) pressure, 4-second integrated relaxation pressure (IRP-4s), distal contractile integral (DCI), distal latency, resting upper esophageal sphincter pressure (UESP), and the response to MRS', 'IRP-4s', 'EGJ-CI']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0989894', 'cui_str': 'sildenafil 50 MG'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014865', 'cui_str': 'Esophageal sphincter'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0232529', 'cui_str': 'Upper esophageal sphincter pressure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0123987', 'cui_str': 'WNT2 protein, human'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",15.0,0.227442,"RESULTS Sildenafil significantly lowered EGJ-CI (P < .001), LES pressure (P = .04), IRP-4s (P = .02), and DCI (P < .001).","[{'ForeName': 'Ming-Wun', 'Initials': 'MW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jui-Sheng', 'Initials': 'JS', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Wei-Yi', 'Initials': 'WY', 'LastName': 'Lei', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chih-Hsun', 'Initials': 'CH', 'LastName': 'Yi', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Tso-Tsai', 'Initials': 'TT', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13840'] 185,32325037,"Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial.","BACKGROUND The Middle East respiratory syndrome coronavirus (MERS-CoV) causes a respiratory disease with a case fatality rate of up to 35%. Given its potential to cause a public health emergency and the absence of efficacious drugs or vaccines, MERS is one of the WHO priority diseases warranting urgent research and development of countermeasures. We aimed to assess safety and tolerability of an anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine candidate that expresses the MERS-CoV spike glycoprotein, MVA-MERS-S, in healthy adults. METHODS This open-label, phase 1 trial was done at the University Medical Center Hamburg-Eppendorf (Hamburg, Germany). Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2 and weight of more than 50 kg at screening, and a negative pregnancy test for women. A key exclusion criterion was a previous MVA vaccination. For the prime immunisation, participants received doses of 1 × 10 7 plaque-forming unit (PFU; low-dose group) or 1 × 10 8 PFU (high-dose group) MVA-MERS-S intramuscularly. A second identical dose was administered intramuscularly as a booster immunisation 28 days after first injection. As a control group for immunogenicity analyses, blood samples were drawn at identical study timepoints from six healthy adults, who did not receive any injections. The primary objectives of the study were safety and tolerability of the two dosage levels and reactogenicity after administration. Immunogenicity was assessed as a secondary endpoint by ELISA and neutralisation tests. T-cell immunity was evaluated by interferon-γ-linked enzyme-linked immune absorbent spot assay. All participants who were vaccinated at least once were included in the safety analysis. Immunogenicity was analysed in the participants who completed 6 months of follow-up. This trial is registered with ClinicalTrials.gov, NCT03615911, and EudraCT, 2014-003195-23 FINDINGS: From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group) were enrolled and received the first dose of the vaccine according to their group allocation. Of these, 23 participants (12 in the low-dose group and 11 in the high-dose group) received a second dose of MVA-MERS-S according to their group allocation after a 28-day interval and completed follow-up. Homologous prime-boost immunisation with MVA-MERS-S revealed a benign safety profile with only transient mild-to-moderate reactogenicity. Participants had no severe or serious adverse events. 67 vaccine-related adverse events were reported in ten (71%) of 14 participants in the low-dose group, and 111 were reported in ten (83%) of 12 participants in the high-dose group. Solicited local reactions were the most common adverse events: pain was observed in 17 (65%; seven in the low-dose group vs ten in the high-dose group) participants, swelling in ten (38%; two vs eight) participants, and induration in ten (38%; one vs nine) participants. Headaches (observed in seven participants in the low-dose group vs nine in the high-dose group) and fatigue or malaise (ten vs seven participants) were the most common solicited systemic adverse events. All adverse events resolved swiftly (within 1-3 days) and without sequelae. Following booster immunisation, nine (75%) of 12 participants in the low-dose group and 11 (100%) participants in the high-dose group showed seroconversion using a MERS-CoV S1 ELISA at any timepoint during the study. Binding antibody titres correlated with MERS-CoV-specific neutralising antibodies (Spearman's correlation r=0·86 [95% CI 0·6960-0·9427], p=0·0001). MERS-CoV spike-specific T-cell responses were detected in ten (83%) of 12 immunised participants in the low-dose group and ten (91%) of 11 immunised participants in the high-dose group. INTERPRETATION Vaccination with MVA-MERS-S had a favourable safety profile without serious or severe adverse events. Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development. FUNDING German Center for Infection Research.",2020,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","['Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2 and weight of more than 50 kg at screening, and a negative pregnancy test for women', 'six healthy adults, who did not receive any injections', 'healthy adults', 'All participants who were vaccinated at least once were included in the safety analysis', 'Middle East respiratory syndrome', 'University Medical Center Hamburg-Eppendorf (Hamburg, Germany', ' From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group', '2014-003195-23', '23 participants (12 in the low-dose group and 11 in the high-dose group']","['1\u2008×\u200810 7 plaque-forming unit (PFU; low-dose group) or 1\u2008×\u200810 8 PFU (high-dose group) MVA-MERS-S intramuscularly', 'MVA-MERS-S', 'modified vaccinia virus Ankara vector vaccine candidate', 'anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine']","['adverse events', 'fatigue or malaise', 'Safety and immunogenicity', 'MERS-CoV spike-specific T-cell responses', 'safety and tolerability', 'Immunogenicity', 'severe or serious adverse events', 'seroconversion using a MERS-CoV S1 ELISA', 'Headaches', 'adverse events: pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042216', 'cui_str': 'Vaccinia virus'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",6.0,0.132455,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dahlke', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Krähling', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Nisreen M A', 'Initials': 'NMA', 'LastName': 'Okba', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eickmann', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Asisa', 'Initials': 'A', 'LastName': 'Volz', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesterkamp', 'Affiliation': 'German Center for Infection Research, Hanover-Brunswick, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Borregaard', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'My L', 'Initials': 'ML', 'LastName': 'Ly', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Zinser', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bartels', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Joseph S H', 'Initials': 'JSH', 'LastName': 'Poetsch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Neumann', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fux', 'Affiliation': 'Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmiedel', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Haagmans', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Sutter', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Marylyn M', 'Initials': 'MM', 'LastName': 'Addo', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany. Electronic address: m.addo@uke.de.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30248-6'] 186,31954696,Relative Effectiveness of Electroacupuncture and Biofeedback in the Treatment of Neck and Upper Back Myofascial Pain: A Randomized Clinical Trial.,"OBJECTIVE To determine the differences between clinical effects of electroacupuncture and biofeedback therapy in addition to conventional treatment in patients with cervical myofascial pain syndrome (MPS). DESIGN Randomized clinical trial. SETTING Physical medicine and rehabilitation clinic of a university hospital. PARTICIPANTS Fifty patients (N=50) aged 25-55 years of both sexes with chronic neck pain diagnosed with MPS (characterized by trigger points within taut bands) were randomly assigned to 2 equal groups of 25 individuals. INTERVENTIONS The patients in electroacupuncture group were treated with standard acupuncture and concomitant electrical stimulation; those in biofeedback group received visual electromyography biofeedback therapy for muscle activity and relaxation. Both groups received the intervention 2 times a week for a total of 6 sessions. Basic exercise training and medicines were administered for all the patients. MAIN OUTCOME MEASURES Pain severity based on the visual analog scale (VAS), functional status using Neck Disability Index (NDI), cervical range of motion (ROM) using and inclinometer, and pressure pain threshold (PPT) using an algometer were evaluated before and at 3 and 12 weeks after the treatment. Primary outcome was defined as 20% reduction in the 3-month neck pain and dysfunction compared to baseline, assessed through the NDI. RESULTS Fifty patients (39 women, 11 men) with a mean age (years) ± SD of 39.0±5.5 and neck pain duration (weeks) of 6.0±2.2 were analyzed. All parameters, except for PPT of the lower trapezius and paravertebral muscles were improved significantly in both groups, while baseline values were controlled. The primary outcome was achieved more significantly in the acupuncture group than in the biofeedback group: 20 (80.0%) vs 10 (40.0%); rate ratio=2 with 95% confidence interval (CI), 1.19-3.36; number needed to treat (NNT)=2.5 with 95% CI, 1.54-6.58. Advantages of acupuncture over biofeedback were observed according to values obtained from the NDI, VAS, extension and left lateral-bending ROM, and PPT on the left upper trapezius after the last session of intervention until 3 months (P<.05). CONCLUSIONS Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment. However, intergroup differences showed priority of acupuncture in some parameters vs biofeedback. Thus, electroacupuncture seems to be a better complementary modality for treatment of MPS in the neck and upper back area.",2020,Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment.,"['50 patients (39 women, 11 men) with an average age of 39.0 (5.5) years old and neck pain duration of 6.0(2.2) weeks were analyzed', '50 patients aged 25-55 years old of both genders with chronic neck pain diagnosed to have MPS (characterized by trigger points within taut bands', 'Physical medicine and rehabilitation clinic of a university hospital', 'patients with cervical Myofascial Pain Syndrome (MPS']","['standard acupuncture concomitant electrical stimulation and those in biofeedback group received visual EMG-biofeedback therapy', 'acupuncture', 'Electroacupuncture and Biofeedback', 'electroacupuncture', 'electro-acupuncture and biofeedback therapy']","['Pain severity based on Visual Analogue Scale (VAS), functional status using Neck Disability Index (NDI), cervical Range of Motion (ROM) using inclinometer and Pressure Pain Threshold (PPT', 'PPT of lower trapezius and paravertebral muscles', 'Myofascial Pain', 'Neck and Upper Back', '3-month neck pain and dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C4019022', 'cui_str': 'Taut (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0027073', 'cui_str': 'Myofascial Pain Syndromes'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C0230101', 'cui_str': 'Upper back structure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",39.0,0.112742,Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment.,"[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Eslamian', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: fariba_eslamian@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jahanjoo', 'Affiliation': 'Road Traffic Injury Research Center, Department of Biostatistic and Epidemiology,Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Dolatkhah', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Pishgahi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Pirani', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.009'] 187,32322880,Neural correlates of cognitive bias modification for interpretation.,"The effectiveness of cognitive bias modification for interpretation (CBM-I), a treatment method employed to reduce social anxiety (SA), has been examined. However, the neural correlates of CBM-I remain unclear, and we aimed to elucidate brain activities during intervention and activity changes associated with CBM-I effectiveness in a pre-post intervention comparison. Healthy participants divided into two groups (CBM, control) were scanned before, during and after intervention using functional magnetic resonance imaging. Ambiguous social situations followed by positive outcomes were repeatedly imagined by the CBM group during intervention, while half of the outcomes in the control group were negative. Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group. Furthermore, altered activities in the somatomotor and somatosensory areas, occipital lobe and posterior cingulate gyrus during interpreting ambiguous social situations showed a significant group × change in SA interaction. Our result suggests that when facing ambiguous social situations, positive imagery instilled by CBM-I is recalled, and interpretations are modified to contain social reward. These findings may help to suggest an alternative manner of enhancing CBM-I effectiveness from a cognitive-neuroscience perspective.",2020,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.",['Healthy participants'],[],"['social anxiety (SA', 'activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0458361', 'cui_str': 'Somesthetic area'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0228243', 'cui_str': 'Structure of lateral occipitotemporal gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0220369,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sakaki', 'Affiliation': 'Department of Functional Brain Imaging, Graduate School of Medicine, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Nozawa', 'Affiliation': 'Research Institute for the Earth Inclusive Sensing Empathizing with Silent Voices, Tokyo Institute of Technology, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa026'] 188,32003413,Transition to a More even Distribution of Daily Protein intake Is Associated with Enhanced Fat Loss during a Hypocaloric and Physical Activity Intervention in Obese Older Adults.,"BACKGROUND Optimization of intentional weight loss in obese older adults, through preferential fat mass reduction, is challenging, as the concomitant lean mass loss may exacerbate sarcopenia. Recent studies have suggested within-day distribution of protein intake plays a role in determining body composition remodeling. Here, we assessed whether changes in within-day protein intake distribution are related to improvements in body composition in overweight/obese older adults during a hypocaloric and exercise intervention. METHODS Thirty-six community-dwelling, overweight-to-obese (BMI 28.0-39.9 kg/m2), sedentary older adults (aged 70.6±6.1 years) were randomized into either physical activity plus successful aging health education (PA+SA; n=15) or physical activity plus weight loss (PA+WL; n=21) programs. Body composition (by CT and DXA) and dietary intake (by three-day food records) were determined at baseline, 6-month, and 12-month follow-up visits. Within-day protein distribution was calculated as the coefficient of variation (CV) of protein ingested per defined time periods (breakfast [5:00-10:59], lunch [11:00-16:59] and dinner [17:00-1:00]). Secondary analysis was performed to determine associations between changes in protein intake distribution and body composition. RESULTS In both groups, baseline protein intake was skewed towards dinner (PA+SA: 49.1%; PA+WL: 54.1%). The pattern of protein intake changed towards a more even within-day distribution in PA+WL during the intervention period, but it remained unchanged in PA+SA. Transition towards a more even pattern of protein intake was independently associated with a greater decline in BMI (P<0.05) and abdominal subcutaneous fat (P<0.05) in PA+WL. However, changes in protein CV were not associated with changes in body weight in PA+SA. CONCLUSION Our results show that mealtime distribution of protein intake throughout the day was associated with improved weight and fat loss under hypocaloric diet combined with physical activity. This finding provides a novel insight into the potential role of within-day protein intake on weight management in obese older people.",2020,Transition towards a more even pattern of protein intake was independently associated with a greater decline in BMI (P<0.05) and abdominal subcutaneous fat (P<0.05) in PA+WL.,"['obese older people', 'Obese Older Adults', 'Thirty-six', 'obese older adults', 'overweight/obese older adults', 'community-dwelling, overweight-to-obese (BMI 28.0-39.9 kg/m2), sedentary older adults (aged 70.6±6.1 years']","['hypocaloric and exercise intervention', 'Hypocaloric and Hhysical Activity Intervention', 'physical activity plus successful aging health education (PA+SA; n=15) or physical activity plus weight loss (PA+WL; n=21) programs']","['body composition', 'Body composition (by CT and DXA) and dietary intake', 'protein intake distribution and body composition', 'weight and fat loss', 'body weight', 'baseline protein intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018701'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",36.0,0.0218255,Transition towards a more even pattern of protein intake was independently associated with a greater decline in BMI (P<0.05) and abdominal subcutaneous fat (P<0.05) in PA+WL.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Farsijani', 'Affiliation': 'Anne B. Newman, 5126 Public Health, 130 DeSoto Street, Pittsburgh, PA 15261, Office (412) 624-3056 Fax (412) 624-3737, Email: newmana@edc.pitt.edu.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Santanasto', 'Affiliation': ''}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Boudreau', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1313-8'] 189,32004517,Chronic Pain Self-Management Support With Pain Science Education and Exercise (COMMENCE) for People With Chronic Pain and Multiple Comorbidities: A Randomized Controlled Trial.,"OBJECTIVE To investigate the effectiveness of chronic pain self-management support with pain science education and exercise (COMMENCE) on improving function, pain interference, work status, pain intensity, fatigue, psychological factors associated with pain, health care visits, satisfaction, and perceived change compared with usual care. DESIGN Parallel group randomized controlled trial with 1- and 12-week follow-ups. SETTING Community health center. PARTICIPANTS Adults (N=102) with chronic noncancer pain referred for self-management support. Eighty of 102 participants completed 12-week follow-up assessments. No participants withdrew with adverse events. INTERVENTIONS Participants were randomized to COMMENCE or usual care. MAIN OUTCOME MEASURES Primary: Function measured using the Short Musculoskeletal Function Assessment-Dysfunction Index. Secondary: Short Musculoskeletal Function Assessment-Bother Index, Patient Reported Outcomes Measurement Information System pain interference, work status, numeric pain, and fatigue rating scales, Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Pain Self-Efficacy Scale, Neurophysiology of Pain Questionnaire, number of health care visits, satisfaction, and global rating of change. RESULTS COMMENCE resulted in greater improvements in function (mean difference [MD] at 12-wk follow-up=-8.0; 95% CI, -14.7 to -1.3), bother with functional difficulties (MD, -12.0; 95% CI, -20.8 to -3.2), pain intensity (MD, -1.0; 95% CI, -2.1 to -0.1), catastrophizing (MD , -8.2; 95% CI, -14.5 to -2.0), self-efficacy (MD, 7.0; 95% CI, 0.8-13.2), knowledge (MD, 2.8; 95% CI, 1.6-3.9), satisfaction (MD, 1.2; 95% CI, 0.7-1.8), and perceived change (MD, 1.4; 95% CI, 0.8-2.1). There were no significant between-group differences in pain interference, work, fatigue, depressive symptoms, or health care visits. CONCLUSION COMMENCE is more effective than usual care at improving function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change but not pain interference, work status, fatigue, depressive symptoms, or health care visits.",2020,"CONCLUSION COMMENCE is more effective than usual care at improving function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change, but not pain interference, work status, fatigue, depressive symptoms, or health care visits.","['Adults (n=102) with chronic non-cancer pain referred for self-management support', 'Community health centre', 'people with chronic pain and multiple comorbidities', 'Eighty of 102 participants completed 12-week follow-up assessments']","['pain science EducatioN and exerCisE (COMMENCE', 'pain science education and exercise']","['self-efficacy', 'pain intensity', 'Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index', 'bother with functional difficulties', 'pain interference, work, fatigue, depressive symptoms, or healthcare visits', 'improving function, pain interference, work status, pain intensity, fatigue, psychological factors associated with pain, health care visits, satisfaction, and perceived change compared to usual care', 'function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change, but not pain interference, work status, fatigue, depressive symptoms, or health care visits', 'SMFA bother index, PROMIS pain interference, work status, numeric pain and fatigue rating scales, Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Pain Self-Efficacy Scale, Neurophysiology of Pain Questionnaire, number of healthcare visits, satisfaction, and global rating of change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal Physiological Concepts'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",102.0,0.193187,"CONCLUSION COMMENCE is more effective than usual care at improving function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change, but not pain interference, work status, fatigue, depressive symptoms, or health care visits.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada. Electronic address: jordan.miller@queensu.ca.'}, {'ForeName': 'Joy C', 'Initials': 'JC', 'LastName': 'MacDermid', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Walton', 'Affiliation': 'School of Physical Therapy, Western University, London, Ontario, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.016'] 190,32320144,Weight Change 2 Years After Termination of the Intensive Lifestyle Intervention in the Look AHEAD Study.,"OBJECTIVE This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss-maintenance counseling than would participants in the diabetes support and education (DSE) control group. METHODS Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes. Look AHEAD was converted to an observational study in September 2012. RESULTS Two years after the end of the intervention (EOI), ILI and DSE participants lost a mean  (SE) of 1.2  (0.2) kg and 1.8  (0.2) kg, respectively (P = 0.003). In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001). Two years after the EOI, ILI participants reported greater use of weight-control behaviors than DSE participants. CONCLUSIONS Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.",2020,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","['participants with overweight/obesity and type 2 diabetes', 'Two years after the end of the intervention (EOI), ILI and DSE participants', 'Weight Change 2 Years']","['ILI and DSE', '10-year intensive lifestyle intervention (ILI', 'Intensive Lifestyle Intervention']","['cardiovascular morbidity and mortality', 'EOI weight', 'gain weight', 'weight-control behaviors']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}]",,0.0402555,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Division of Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bolin', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Ewing', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Gay', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Department of Integrative Physiology and Metabolism, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Michalski', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reboussin', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redmon', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinburg', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22769'] 191,32275653,"The impact of insecticide treated curtains on dengue virus transmission: A cluster randomized trial in Iquitos, Peru.","Dengue is one of the most important vector-borne diseases, resulting in an estimated hundreds of millions of infections annually throughout the tropics. Control of dengue is heavily dependent upon control of its primary mosquito vector, Aedes aegypti. Innovative interventions that are effective at targeting the adult stage of the mosquito are needed to increase the options for effective control. The use of insecticide-treated curtains (ITCs) has previously been shown to significantly reduce the abundance of Ae. aegypti in and around homes, but the impact of ITCs on dengue virus (DENV) transmission has not been rigorously quantified. A parallel arm cluster-randomized controlled trial was conducted in Iquitos, Peru to quantify the impact of ITCs on DENV seroconversion as measured through plaque-reduction neutralization tests. Seroconversion data showed that individuals living in the clusters that received ITCs were at greater risk to seroconverting to DENV, with an average seroconversion rate of 50.6 per 100 person-years (PY) (CI: 29.9-71.9), while those in the control arm had an average seroconversion rate of 37.4 per 100 PY (CI: 15.2-51.7). ITCs lost their insecticidal efficacy within 6 months of deployment, necessitating re-treatment with insecticide. Entomological indicators did not show statistically significant differences between ITC and non-ITC clusters. It's unclear how the lack of protective efficacy reported here is attributable to simple failure of the intervention to protect against Ae. aegypti bites, or the presence of a faulty intervention during much of the follow-up period. The higher risk of dengue seroconversion that was detected in the ITC clusters may have arisen due to a false sense of security that inadvertently led to less routine protective behaviors on the part of households that received the ITCs. Our study provides important lessons learned for conducting cluster randomized trials for vector control interventions against Aedes-transmitted virus infections.",2020,"Seroconversion data showed that individuals living in the clusters that received ITCs were at greater risk to seroconverting to DENV, with an average seroconversion rate of 50.6 per 100 person-years (PY) (CI: 29.9-71.9), while those in the control arm had an average seroconversion rate of 37.4 per 100 PY (CI: 15.2-51.7).",[],['insecticide-treated curtains (ITCs'],['average seroconversion rate'],[],"[{'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0180239', 'cui_str': 'Curtain'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",,0.0895834,"Seroconversion data showed that individuals living in the clusters that received ITCs were at greater risk to seroconverting to DENV, with an average seroconversion rate of 50.6 per 100 person-years (PY) (CI: 29.9-71.9), while those in the control arm had an average seroconversion rate of 37.4 per 100 PY (CI: 15.2-51.7).","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lenhart', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Morrison', 'Affiliation': 'Department of Pathology, Microbiology, and Immunology, School of Veterinary Medicine, University of California, Davis, California, United States of America.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Paz-Soldan', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Forshey', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'Jhonny J', 'Initials': 'JJ', 'LastName': 'Cordova-Lopez', 'Affiliation': 'Department of Pathology, Microbiology, and Immunology, School of Veterinary Medicine, University of California, Davis, California, United States of America.'}, {'ForeName': 'Helvio', 'Initials': 'H', 'LastName': 'Astete', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Elder', 'Affiliation': 'San Diego State University, San Diego, California, United States of America.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Sihuincha', 'Affiliation': 'Director, Department of Internal Medicine, Hospital de Apoyo Iquitos, Peru.'}, {'ForeName': 'Esther E', 'Initials': 'EE', 'LastName': 'Gotlieb', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Halsey', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'Tadeusz J', 'Initials': 'TJ', 'LastName': 'Kochel', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Scott', 'Affiliation': 'Department of Entomology and Nematology, University of California, Davis, California, United States of America.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'McCall', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008097'] 192,31605793,A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study.,"INTRODUCTION The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy. METHODS Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed. RESULTS From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4-4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4-1.5 months] versus 1.8 months [95% CI: 1.3-5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4-2.6 months] versus 1.3 months [95% CI: 1.0-5.3 months], respectively [p = 0.04]). CONCLUSIONS Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.",2020,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively. ","['patients with extensive stage (ES) SCLC after completion of first line chemotherapy', 'patients with extensive stage SCLC (ES-SCLC) who were stable or responding after at least 4 cycles of platinum-based chemotherapy: NCCTG (Alliance) N0923 Study', 'ES-SCLC patients who did not progress after ≥4 cycles of platinum-based chemotherapy', 'From January 15, 2010 to January 10, 2013, 50 patients']","['Seneca Valley Virus (NTX-010) vs placebo', 'placebo', 'NTX-010', 'NTX-010 or placebo']","['progression free survival (PFS', 'median PFS', 'Viral clearance and the development of neutralizing antibodies', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1831871', 'cui_str': 'Senecavirus A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",50.0,0.392168,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively. ","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Schenk', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Dy', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Aubry', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Newton, Kansas.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Sachs', 'Affiliation': 'The Toledo Clinic-Maumee, Maumee, Ohio.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Nieva', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Bertino', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lee Hann', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Troy W', 'Initials': 'TW', 'LastName': 'Wadsworth', 'Affiliation': 'Northwest NCORP, Multicare Regional Cancer Center, Tacoma, Washington.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Molina', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota. Electronic address: molina.julian@mayo.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.083'] 193,31444404,Low-molecular-weight-heparin increases Th1- and Th17-associated chemokine levels during pregnancy in women with unexplained recurrent pregnancy loss: a randomised controlled trial.,"Low-molecular-weight heparin (LMWH) is widely used to treat recurrent pregnancy loss (RPL) because of its anti-coagulant effects. Although in vitro studies have suggested additional immunological effects, these are debated. We therefore investigated whether LMWH could modulate immune responses in vivo during pregnancy of women with unexplained RPL. A Swedish open multi-centre randomised controlled trial included 45 women treated with tinzaparin and 42 untreated women. Longitudinally collected plasma samples were obtained at gestational weeks (gw) 6, 18, 28 and 34 and analysed by multiplex bead technology for levels of 11 cytokines and chemokines, chosen to represent inflammation and T-helper subset-associated immunity. Mixed linear models test on LMWH-treated and untreated women showed differences during pregnancy of the Th1-associated chemokines CXCL10 (p = 0.01), CXCL11 (p < 0.001) and the Th17-associated chemokine CCL20 (p = 0.04), while CCL2, CCL17, CCL22, CXCL1, CXCL8, CXCL12, CXCL13 and IL-6 did not differ. Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34. The consistent increase in the two Th1-associated chemokines suggests a potential proinflammatory and unfavourable effect of LMWH treatment during later stages of pregnancy, when Th1 immunity is known to disrupt immunological tolerance.",2019,Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34.,"['women with unexplained RPL', '45 women treated with', 'women with unexplained recurrent pregnancy loss', 'and 42 untreated women']","['LMWH', 'tinzaparin', 'Low-molecular-weight heparin (LMWH']","['Th17-associated chemokine CCL20', 'CCL2, CCL17, CCL22, CXCL1, CXCL8, CXCL12, CXCL13', 'CXCL11', 'plasma levels of CXCL10 and CXCL11']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0216278', 'cui_str': 'tinzaparin'}]","[{'cui': 'C1961104', 'cui_str': 'Small Inducible Cytokine A20'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",45.0,0.211614,Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rasmark Roepke', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö and Lund University, Lund, Sweden. emma_36@hotmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bruno', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nedstrand', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boij', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C Petersson', 'Initials': 'CP', 'LastName': 'Strid', 'Affiliation': 'Departmen of Obstetrics and Gynecology, Kalmar Hospital, Kalmar, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piccione', 'Affiliation': 'Section of Gynecology and Obstetrics, Academic Department of Biomedicine and Prevention, and Clinical Department of Surgery, Tor Vergata University Hospital, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Svensson-Arvelund', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-019-48799-6'] 194,32324830,"Correction: Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia.",[This corrects the article DOI: 10.1371/journal.pone.0230703.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0230703.].,"['Youth Engaging for Success', 'HIV-positive youth (15-24 years) in Ndola, Zambia']",['clinic-based peer mentoring program'],"['viral suppression, adherence and internalized stigma']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.040727,[This corrects the article DOI: 10.1371/journal.pone.0230703.].,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Denison', 'Affiliation': ''}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Miti', 'Affiliation': ''}, {'ForeName': 'Bareng A S', 'Initials': 'BAS', 'LastName': 'Nonyane', 'Affiliation': ''}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Frimpong', 'Affiliation': ''}, {'ForeName': 'Katherine G', 'Initials': 'KG', 'LastName': 'Merrill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Abrams', 'Affiliation': ''}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Mwansa', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232488'] 195,32318103,Effects of Rubber Hand Illusion and Excitatory Theta Burst Stimulation on Tactile Sensation: A Pilot Study.,"Synchronous visuotactile stimulation on the own hidden hand and a visible fake limb can alter bodily self-perception and influence spontaneous neuroplasticity. The rubber hand illusion (RHI) paradigm experimentally produces an illusion of rubber hand ownership and arm shift by simultaneously stroking a rubber hand in view and a participant's visually occluded hand. The aim of this cross-over, placebo-controlled, single-blind study was to assess whether RHI, in combination with high-frequency repetitive transcranial magnetic stimulation (rTMS) given as intermittent (excitatory) theta burst stimulation (iTBS) applied over the hand area of the primary sensory region (S1) can enhance tactile sensation in a group of 21 healthy subjects and one patient with cervical spinal cord injury. Four sessions covered all combinations of real and sham stimulations of the RHI and the TBS: real TBS and real RHI, real TBS and sham RHI, sham TBS and real RHI, and both conditions sham. The condition sham TBS and real RHI shows the greatest effect on the proprioceptive drift (median 2.3 cm, IQR 2) and on the score of RHI questionnaires (median 3, IQR 2) in the control group as well as in the real-real condition (median 2, IQR 2). The sham TBS and real RHI condition also shows the best results in the electrical perception test of the patient (median 1.9 mA). Conversely, the upregulation of the cortical excitability of S1 via TBS seems to impair the effect of the RHI. This might be due to a strengthening of the top-down connection between the central nervous system and the periphery, diminishing the RHI. This finding helps in understanding the mechanisms of top-down and bottom-up mechanisms in healthy subjects and patients with spinal cord injury. The RHI paradigm could represent an interesting therapeutic approach in improving tactile sensation and rTMS techniques could modulate these effects. Yet, further studies are needed, to examine the direction of the interaction effect of TMS and RH.",2020,"The condition sham TBS and real RHI shows the greatest effect on the proprioceptive drift (median 2.3 cm, IQR 2) and on the score of RHI questionnaires (median 3, IQR 2) in the control group as well as in the real-real condition (median 2, IQR 2).","['healthy subjects and patients with spinal cord injury', '21 healthy subjects and one patient with cervical spinal cord injury']","['RHI, in combination with high-frequency repetitive transcranial magnetic stimulation (rTMS) given as intermittent (excitatory) theta burst stimulation (iTBS', 'Rubber Hand Illusion and Excitatory Theta Burst Stimulation', 'placebo']","['score of RHI questionnaires', 'tactile sensation', 'proprioceptive drift', 'Tactile Sensation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}]",21.0,0.0621843,"The condition sham TBS and real RHI shows the greatest effect on the proprioceptive drift (median 2.3 cm, IQR 2) and on the score of RHI questionnaires (median 3, IQR 2) in the control group as well as in the real-real condition (median 2, IQR 2).","[{'ForeName': 'Vanessa N', 'Initials': 'VN', 'LastName': 'Frey', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Butz', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kunz', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Höller', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Golaszewski', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Trinka', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Nardone', 'Affiliation': 'Department of Neurology and Neuroscience Institute, Christian Doppler University Hospital, Spinal Cord Injury and Tissue Regeneration Center, PMU, Salzburg, Austria.'}]",Neural plasticity,['10.1155/2020/3069639'] 196,31860405,Impact of Conditioning Intensity of Allogeneic Transplantation for Acute Myeloid Leukemia With Genomic Evidence of Residual Disease.,"PURPOSE Patients with acute myeloid leukemia (AML) in remission remain at risk for relapse even after allogeneic hematopoietic cell transplantation (alloHCT). AML measurable residual disease (MRD) status before alloHCT has been shown to be prognostic. Whether modulation of the intensity of the alloHCT conditioning regimen in patients with AML who test positive for MRD can prevent relapse and improve survival is unknown. METHODS Ultra-deep, error-corrected sequencing for 13 commonly mutated genes in AML was performed on preconditioning blood from patients treated in a phase III clinical trial that randomly assigned adult patients with myeloid malignancy in morphologic complete remission to myeloablative conditioning (MAC) or reduced-intensity conditioning (RIC). RESULTS No mutations were detected in 32% of MAC and 37% of RIC recipients; these groups had similar survival (3-year overall survival [OS], 56% v 63%; P = .96). In patients with a detectable mutation (next-generation sequencing [NGS] positive), relapse (3-year cumulative incidence, 19% v 67%; P < .001) and survival (3-year OS, 61% v 43%; P = .02) was significantly different between the MAC and RIC arms, respectively. In multivariable analysis for NGS-positive patients, adjusting for disease risk and donor group, RIC was significantly associated with increased relapse (hazard ratio [HR], 6.38; 95% CI, 3.37 to 12.10; P < .001), decreased relapse-free survival (HR, 2.94; 95% CI, 1.84 to 4.69; P < .001), and decreased OS (HR, 1.97; 95% CI, 1.17 to 3.30; P = .01) compared with MAC. Models of AML MRD also showed benefit for MAC over RIC for those who tested positive. CONCLUSION This study provides evidence that MAC rather than RIC in patients with AML with genomic evidence of MRD before alloHCT can result in improved survival.",2020,"No mutations were detected in 32% of MAC and 37% of RIC recipients; these groups had similar survival (3-year overall survival [OS], 56% v 63%; P = .96).","['patients with AML who test positive for MRD', 'Patients with acute myeloid leukemia (AML) in remission remain at risk for relapse even after allogeneic hematopoietic cell transplantation (alloHCT', 'Acute Myeloid Leukemia With Genomic Evidence of Residual Disease', 'patients with AML']","['myeloablative conditioning (MAC) or reduced-intensity conditioning (RIC', 'Allogeneic Transplantation']","['similar survival (3-year overall survival [OS', 'survival', 'relapse-free survival', 'AML measurable residual disease (MRD) status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0153886', 'cui_str': 'Acute myeloid leukemia in remission (disorder)'}, {'cui': 'C1320679', 'cui_str': 'At risk for relapse'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic Grafting'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.413975,"No mutations were detected in 32% of MAC and 37% of RIC recipients; these groups had similar survival (3-year overall survival [OS], 56% v 63%; P = .96).","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Hourigan', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'Dillon', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Gege', 'Initials': 'G', 'LastName': 'Gui', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Fei', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Ghannam', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Yuesheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Licon', 'Affiliation': 'ArcherDX, Boulder, CO.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Alyea', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Bashey', 'Affiliation': 'Blood and Marrow Transplant Program at Northside Hospital, Atlanta, GA.'}, {'ForeName': 'H Joachim', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': 'National Marrow Donor Program and Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Hugo F', 'Initials': 'HF', 'LastName': 'Fernandez', 'Affiliation': 'Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': 'West Virginia University Medicine, Morgantown, WV.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'National Marrow Donor Program and Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Porter', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Scott', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Warlick', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Horwitz', 'Affiliation': 'Duke University, Durham, NC.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03011'] 197,32211953,Mild stimulation protocol vs conventional controlled ovarian stimulation protocol in poor ovarian response patients: a prospective randomized controlled trial.,"PURPOSE To compare the efficacy of mild ovarian stimulation protocol and conventional controlled ovarian stimulation (COS) protocol for poor ovarian response (POR) patients undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). METHODS This single-center prospective randomized controlled trial conducted from September 2013 to September 2015, including 191 patients who met the Bologna criteria of POR. Ninety-seven patients allocated to the mild ovarian stimulation group (MS group) were stimulated according to the letrozole/antagonist protocol, while 94 patients in the controlled ovarian stimulation group (COS group) were stimulated according to a high dose of gonadotropin (Gn) combined with gonadotropin-releasing hormone agonist (GnRH-a) stop protocol. The cumulative live birth rate was the primary outcome. Chinese clinical trial number ChiCTR-TRC-13003454. RESULTS Comparing with the COS group, both the stimulation duration and the total gonadotropin dose were significantly shorter and lower in the MS group (P < 0.001). A higher number of retrieved oocytes (P = 0.003) and transferrable embryos (P = 0.029) were obtained in the COS group. The cumulative live birth rates (OR 1.103; 95% CI 0.53 to 2.28; P = 0.791) were comparable between the two groups. CONCLUSIONS The increase of Gn dose during ovulation stimulation was associated with a higher number of transferrable embryos for POR patients, but this increase did not lead to a concomitant improvement of reproductive outcome, especially in terms of the cumulative live birth rate. Using a mild stimulation protocol was economically preferential while it was as effective as higher doses of Gn stimulation protocol in reproductive outcome for POR patients.",2020,A higher number of retrieved oocytes (P = 0.003) and transferrable embryos (P = 0.029) were obtained in the COS group.,"['poor ovarian response patients', 'POR patients', 'September 2013 to September 2015, including 191 patients who met the Bologna criteria of POR', 'poor ovarian response (POR) patients undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI']","['mild ovarian stimulation', 'Mild stimulation protocol vs conventional controlled ovarian stimulation protocol', 'controlled ovarian stimulation group (COS group) were stimulated according to a high dose of gonadotropin (Gn) combined with gonadotropin-releasing hormone agonist (GnRH-a) stop protocol', 'COS', 'letrozole/antagonist protocol', 'mild ovarian stimulation protocol and conventional controlled ovarian stimulation (COS) protocol']","['transferrable embryos', 'cumulative live birth rates', 'number of retrieved oocytes', 'stimulation duration and the total gonadotropin dose', 'cumulative live birth rate']","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0454802', 'cui_str': 'Cos (geographic location)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.18977,A higher number of retrieved oocytes (P = 0.003) and transferrable embryos (P = 0.029) were obtained in the COS group.,"[{'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Reproductive Medicine Research Center, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510655, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Reproductive Medicine Research Center, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510655, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Reproductive Medicine Research Center, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510655, China.'}, {'ForeName': 'Xuefen', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Reproductive Medicine Research Center, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510655, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Reproductive Medicine Research Center, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510655, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Reproductive Medicine Research Center, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510655, China. drhuangr@sina.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05513-6'] 198,32313669,Associations between lifestyle intervention-related changes in dietary targets and migraine headaches among women in the Women's Health and Migraine (WHAM) randomized controlled trial.,"Background Migraine and obesity are comorbid particularly in women of reproductive age. Obesity treatment involves reducing energy intake and improving dietary quality but the effect of these changes on migraine is largely unknown. Objective To determine if adherence to dietary intervention targets (ie, total energy, dietary fat intake, and dietary quality) were associated with improvements in migraine and weight. Methods Eighty-four women with overweight/obesity and migraine were randomized to and completed either a 16-week behavioral weight loss (BWL) or a migraine education (ME) intervention. For 28 days at baseline and posttreatment, women recorded monthly migraine days, duration, and maximum pain intensity via smartphone-based diary. At each assessment, weight was measured and dietary intake (total energy intake, percent (%) energy from fat, and diet quality, as measured by the Healthy Eating Index, 2010 [HEI-2010]) was assessed using three nonconsecutive 24-hour diet recalls. Results There were no significant group differences in change mean migraine days per month (BWL: -2.6+4.0, ME: -4.0+4.4; p = 0.1). Participants in BWL significantly reduced their percent fat intake 3.8% ( p = 0.004) and improved total diet quality (HEI-2010) by 6.7 points ( p = 0.003) relative to baseline and those in ME (%fat: +0.3%; p = 0.821; HEI-2010: +0.7; p = 0.725). After controlling for race/ethnicity and weight change, changes in dietary intake were not related to changes in migraine characteristics or weight loss among BWL participants ( p 's > 0.05). Conclusions Changes in dietary intake among participants were small and may have been insufficient to improve migraine in women with overweight/obesity and migraine.",2020,There were no significant group differences in change mean migraine days per month,"['women with overweight/obesity and migraine', 'Methods\n\n\nEighty-four women with overweight/obesity and migraine', ""women in the Women's Health and Migraine (WHAM"", 'women of reproductive age']","['ME', 'lifestyle intervention-related changes in dietary targets', '16-week behavioral weight loss (BWL) or a migraine education (ME) intervention']","['monthly migraine days, duration, and maximum pain intensity via smartphone-based diary', 'total diet quality', 'change mean migraine days per month', 'migraine characteristics or weight loss', 'weight was measured and dietary intake (total energy intake, percent (%) energy from fat, and diet quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",84.0,0.066011,There were no significant group differences in change mean migraine days per month,"[{'ForeName': 'Whitney E', 'Initials': 'WE', 'LastName': 'Evans', 'Affiliation': 'Weight Control and Diabetes Research Center Brown University Alpert Medical School/The Miriam Hospital Providence Rhode Island USA.'}, {'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition University of Tennessee Knoxville Tennessee.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Howie', 'Affiliation': 'Weight Control and Diabetes Research Center Brown University Alpert Medical School/The Miriam Hospital Providence Rhode Island USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Department of Neurology Albert Einstein College of Medicine/Montefiore Medical Center New York USA.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center Brown University Alpert Medical School/The Miriam Hospital Providence Rhode Island USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center Brown University Alpert Medical School/The Miriam Hospital Providence Rhode Island USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Pavlovic', 'Affiliation': 'Department of Neurology Albert Einstein College of Medicine/Montefiore Medical Center New York USA.'}, {'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology, Rutgers the State University of New Jersey Piscataway New Jersey.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Weight Control and Diabetes Research Center Brown University Alpert Medical School/The Miriam Hospital Providence Rhode Island USA.'}]",Obesity science & practice,['10.1002/osp4.376'] 199,31958404,"Effectiveness of post-partum family planning interventions on contraceptive use and method mix at 1 year after childbirth in Kinshasa, DR Congo (Yam Daabo): a single-blind, cluster-randomised controlled trial.","BACKGROUND In rural Burkina Faso, a package of six low-technology, post-partum contraceptive interventions (ie, refresher training for providers, a counselling tool, supportive supervision, daily availability of contraceptive services, client appointment cards, and invitation letters to attend appointments for partners), aimed at strengthening existing primary health-care services and enhancing demand for them, doubled the use of modern contraceptives at 12 months post partum (ie, 55% uptake in intervention recipients vs 29% in routine-care users). This study assessed the effect of a similar package but in urban settings of Kinshasa province, Democratic Republic of the Congo, in an effort to reduce the unmet need for post-partum family planning. METHODS Yam Daabo was a multi-intervention, single-blinded, cluster-randomised controlled trial done in six primary health-care centres (clusters) in Kinshasa. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings. Only data analysts could be masked to cluster allocation. Health-care facilities were eligible if they provided a continuum of antenatal, delivery, and postnatal care, were well stocked with contraceptives, and were situated close to the main study centre. All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility. The main outcome was prevalence of use of modern contraceptives at 12 months after delivery. Analysis was by modified intention-to-treat using generalised linear mixed models or Fisher's exact test for small groups. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). FINDINGS From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised. Of 690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters. Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis. At 12 months, 115 (46%) of 252 women in the intervention group and 94 (35%) of 267 in the control group were using modern contraceptives (adjusted prevalence ratio [PR] 1·58, 95% CI 0·74-3·38), with significant differences in the use of contraceptive implants (22% vs 6%; adjusted PR 4·36, 95% CI 1·96-9·70), but without difference in the use of short-acting contraceptives (23% vs 28%; 0·92, 0·29-2·98) and non-modern or inappropriate methods (7% vs 18%; 0·45, 0·13-1·54). There were no serious adverse events or maternal deaths related to the study. INTERPRETATION The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth. However, interferences from external family planning initiatives in the control group might have diminished differences between the services received. Such an intervention could be potentially relevant in similar contexts in DR Congo and other countries. FUNDING Government of France; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.",2020,The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth.,"['urban settings of Kinshasa province, Democratic Republic of the Congo', 'From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised', '690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters', 'Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis', 'Government of France', 'six primary health-care centres (clusters) in Kinshasa', 'All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility']","['six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings', 'post-partum family planning interventions']","['serious adverse events or maternal deaths', 'overall use of effective modern contraceptives', 'use of contraceptive implants', 'prevalence of use of modern contraceptives', 'Prevalence ratios']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",690.0,0.242724,The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth.,"[{'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, NSW, Australia. Electronic address: nguyen-toan.tran@unige.ch.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Seuc', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Tshikaya', 'Affiliation': 'Programme National de Santé de la Reproduction, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Mutuale', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Landoulsi', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Kini', 'Affiliation': 'World Health Organization Country Office in the Democratic Republic of the Congo, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Mbu Nkolomonyi', 'Affiliation': 'World Health Organization Country Office in the Democratic Republic of the Congo, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nyandwe Kyloka', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Félicité', 'Initials': 'F', 'LastName': 'Langwana', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Cuzin-Kihl', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kiarie', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mary Eluned', 'Initials': 'ME', 'LastName': 'Gaffield', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yodi', 'Affiliation': 'Programme National de Santé de la Reproduction, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Désiré', 'Initials': 'D', 'LastName': 'Mashinda Kulimba', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30546-7'] 200,31919579,Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria.,"Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years. Pharmacokinetic data for children aged 6-11 years were extracted post hoc from a study in which children (2-11 years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10 mg/day). Maximum plasma concentration (C max ) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). Safety data for children aged 6-11 years were extracted post hoc from a phase III randomized controlled trial of children (2-11 years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10 mg or placebo for 12 weeks. Exposure and C max values were similar for children (6-11 years) and adults: median pediatric/adult ratios for AUC 0-24 and C max were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo.Conclusion: Pharmacokinetic and safety analyses in children aged 6-11 years support the suitability of the pediatric dose of bilastine 10 mg and confirm that the safety profiles of bilastine and placebo are similar.What is Known:• Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults (20 mg/day) and children aged ≥ 6 years (10 mg/day).• An ontogenic model based on adult data and pharmacokinetic/pharmacodynamic simulations supported the selection of a bilastine dose of 10 mg/day in children aged 2-11 years. Bilastine 10 mg/day was shown to have a safety profile similar to that of placebo in a large phase III randomized clinical trial in children aged 2-11 years.What is New:• As bilastine is approved in Europe for children aged ≥6 years, the current study reports the results of two post hoc analyses of pharmacokinetic and safety data in children aged 6-11 years.• Analysis of pharmacokinetic and safety data in children aged 6-11 years supports the suitability of the pediatric dose of bilastine 10 mg and confirms that its safety profile is similar to that of placebo.",2020,There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo.,"['children aged 6-11\xa0years were extracted post hoc from a study in which children (2-11\xa0years) with allergic rhinoconjunctivitis or urticaria received', 'children aged ≥6\xa0years', 'children aged 6 to 11\xa0years with allergic rhinoconjunctivitis or chronic urticaria', 'adults and children aged ≥', 'children aged 6-11\xa0years were extracted post hoc from a phase III randomized controlled trial of children (2-11\xa0years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily', 'children aged 6-11\xa0years', 'allergic rhinoconjunctivitis and urticaria in adults (20\xa0mg/day) and children aged ≥', 'children aged 2-11\xa0years']","['bilastine 10\xa0mg or placebo', 'bilastine and placebo', 'antihistamine', 'Bilastine, a second-generation antihistamine', 'placebo', 'Bilastine', 'bilastine', 'oral bilastine']","['Pharmacokinetic and safety', 'Maximum plasma concentration (C max ) and area under the plasma concentration curve (AUC) data', 'Pharmacokinetics and safety', 'Exposure and C max values', 'incidence of treatment-emergent adverse']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0042109', 'cui_str': 'Hives'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C1136312', 'cui_str': 'Second Generation H1 Antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.191356,There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo.,"[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Rodríguez', 'Affiliation': 'Drug Modeling & Consulting, Dynakin S. L., Bilbao, Spain.'}, {'ForeName': 'Valvanera', 'Initials': 'V', 'LastName': 'Vozmediano', 'Affiliation': 'Drug Modeling & Consulting, Dynakin S. L., Bilbao, Spain.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'García-Bea', 'Affiliation': 'Medical Department, FAES FARMA, S. A., 48940, Leioa, Bizkaia, Spain. agarciabea@faes.es.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Novák', 'Affiliation': 'Aranyklinika Egészségügyi és Innovációs Kft, Szeged, Hungary.'}, {'ForeName': 'Anahí', 'Initials': 'A', 'LastName': 'Yáñez', 'Affiliation': 'INAER-Investigaciones en Alergia y Enfermedades Respiratorias, Buenos Aires, Argentina.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Campo', 'Affiliation': 'Medical Department, FAES FARMA, S. A., 48940, Leioa, Bizkaia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Labeaga', 'Affiliation': 'Medical Department, FAES FARMA, S. A., 48940, Leioa, Bizkaia, Spain.'}]",European journal of pediatrics,['10.1007/s00431-019-03559-6'] 201,31542942,Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial.,"BACKGROUND Once-weekly exenatide (EQW) had a neutral effect on hospitalization for heart failure (HHF) in the EXSCEL study (Exenatide Study of Cardiovascular Event Lowering), with no differential treatment effect on major adverse cardiac events by baseline heart failure (HF) status. EQW's effects on secondary end points based on HHF status have not been reported. The objective was to explore the effects of EQW on secondary end points in patients with and without baseline HF and test the effects of EQW on recurrent HHF events. METHODS The prespecified analysis of the randomized controlled EXSCEL trial, which enrolled patients with type 2 diabetes mellitus with and without additional cardiovascular disease, analyzed EQW effects on all-cause death, each major adverse cardiac event component, first HHF, and repeat HHF, by baseline HF status (regardless of ejection fraction). A subgroup analysis of the population stratified by preserved or reduced baseline ejection fraction was performed. RESULTS Of 14 752 EXSCEL participants, 2389 (16.2%) had HF at baseline. Compared with those without HF at baseline, patients with preexisting HF were older, and more likely to be male and white, with a higher burden of other cardiovascular diseases. Overall, those assigned to EQW had a lower incidence of all-cause death (hazard ratio [HR], 0.86 [95% CI, 0.77-0.97]) and the composite outcome of all-cause death or HHF (HR, 0.89 [95% CI, 0.80-0.99]). When stratified by presence or absence of baseline HF, there was no observed reduction in all-cause death with EQW with baseline HF (HR, 1.05 [95% CI, 0.85-1.29]), while the risk of mortality was reduced with EQW in the no-HF group (HR, 0.79 [95% CI, 0.68-0.92]) with an interaction P value of 0.031. The reduction in all-cause death or HHF seen with EQW in patients without baseline HF (HR, 0.81 [95% CI, 0.71-0.93]) was not seen in patients with baseline HF (HR, 1.07 [95% CI, 0.89-1.29]; interaction P =0.015). First, plus recurrent, HHF was reduced in the exenatide group versus placebo (HR, 0.82 [95% CI, 0.68-0.99]; P =0.038). CONCLUSIONS In EXSCEL, the use of EQW in patients with or without HF was well tolerated, but benefits of EQW on reduction in all-cause death and first hospitalization for HF were attenuated in patients with baseline HF. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov. Unique identifier: NCT01144338.",2019,"Overall, those assigned to EQW had a lower incidence of all-cause death (HR 0.86, 95%CI 0.77-0.97) and the composite outcome of all-cause death or hHF (HR 0.89, 95%CI 0.80-0.99).","['enrolled patients with type 2 diabetes with and without additional cardiovascular disease, analyzed EQW effects on all-cause death, each MACE component, first hHF and repeat hHF by baseline HF status (regardless of ejection fraction', 'patients with and without baseline HF', 'Patients With Type 2 Diabetes With and Without Heart Failure and Heart Failure-Related Outcomes']","['placebo', 'EQW', 'Once-Weekly Exenatide', 'exenatide (EQW']","['risk of mortality', 'recurrent hHF', 'major adverse cardiac events (MACE) by baseline heart failure (HF) status', 'incidence of all-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.396181,"Overall, those assigned to EQW had a lower incidence of all-cause death (HR 0.86, 95%CI 0.77-0.97) and the composite outcome of all-cause death or hHF (HR 0.89, 95%CI 0.80-0.99).","[{'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Wainstein', 'Affiliation': 'Diabetes Unit, The E. Wolfson Medical Center, Sackler Tel-Aviv University, Israel (J.W.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Murin', 'Affiliation': 'University Hospital, Bratislava, Slovakia (J.M.).'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Öhman', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Reicher', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, United Kingdom (R.R.H.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041659'] 202,31975493,Anodal transcranial direct current stimulation and intermittent theta-burst stimulation improve deglutition and swallowing reproducibility in elderly patients with dysphagia.,"BACKGROUND Dysphagia in the elderly, known as presbydysphagia, has become a relevant public health problem in several countries. Swallowing disorders may be a consequence of different neurological disorders (secondary presbydysphagia) or the expression of the aging process itself (primary presbydysphagia). We aimed to test the therapeutic potential of two different non-invasive brain stimulation (NIBS) techniques in subjects with primary or secondary presbydysphagia. METHODS A blinded randomized controlled trial with crossover design was carried out in 42 patients, randomly assigned to anodal transcranial direct current stimulation (tDCS) or intermittent theta-burst stimulation (TBS) group. Both tDCS and TBS were applied for 5 consecutive days over the right swallowing motor cortex. The swallowing function was assessed before and 1 and 3 months after the stimulation using the Dysphagia Outcome and Severity Scale (DOSS), scored based on clinical assessment and fiberoptic endoscopic evaluation of swallowing. An electrophysiological method was also applied to evaluate changes in the reproducibility of the swallowing behavior. KEY RESULTS Both real tDCS and TBS had beneficial effects on the swallowing function in patients with primary and secondary presbydysphagia. Anodal tDCS resulted in an improvement of 0.5 points in DOSS at 1-month follow-up (P = .014), whereas intermittent TBS induced an increase of 0.7 and 0.6 points at 1- and 3-month follow-up evaluations, respectively (P = .0001 and P = .005, respectively). Reproducibility of both the oral and pharyngeal phases of swallowing significantly increased at 1-month follow-up. CONCLUSIONS AND INFERENCES Our results suggest that non-invasive cortical stimulation may be useful for dysphagia recovery in elderly patients.",2020,"Reproducibility of both the oral and pharyngeal phases of swallowing significantly increased at 1-month follow-up. ","['elderly patients with dysphagia', 'subjects with primary or secondary presbydysphagia', 'patients with primary and secondary presbydysphagia', '42 patients', 'elderly patients']","['anodal transcranial direct current stimulation (tDCS) or intermittent theta-burst stimulation (TBS) group', 'invasive brain stimulation (NIBS) techniques', 'Anodal transcranial direct current stimulation and intermittent theta-burst stimulation', 'Anodal tDCS', 'TBS']","['DOSS', 'swallowing function', 'Reproducibility of both the oral and pharyngeal phases of swallowing', 'Dysphagia Outcome and Severity Scale (DOSS), scored based on clinical assessment and fiberoptic endoscopic evaluation of swallowing', 'deglutition and swallowing reproducibility', 'intermittent TBS']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1692318', 'cui_str': 'Docusate'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C4707950', 'cui_str': 'Dysphagia Outcome and Severity Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]",42.0,0.0310444,"Reproducibility of both the oral and pharyngeal phases of swallowing significantly increased at 1-month follow-up. ","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Cosentino', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tassorelli', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Prunetti', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bertino', 'Affiliation': 'Department of Otolaryngology, University of Pavia, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'De Icco', 'Affiliation': 'Neurorehabilitation Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Todisco', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Di Marco', 'Affiliation': 'Department of Biomedicine Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Brighina', 'Affiliation': 'Department of Biomedicine Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Schindler', 'Affiliation': 'Department of Clinical Sciences ""Luigi Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'Section of Human Nutrition and Dietetics, Department of Public Health and Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Fresia', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mainardi', 'Affiliation': 'Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Domenico A', 'Initials': 'DA', 'LastName': 'Restivo', 'Affiliation': 'Department of Neurology, Garibaldi Hospital, Catania, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Priori', 'Affiliation': ""Department of Neurological Sciences, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sandrini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Alfonsi', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13791'] 203,30230970,A single-session positive cognitive intervention on first-year students' mental health: Short-term effectiveness and the mediating role of strengths knowledge.,"Objective: To better understand the effectiveness of a single-session positive cognitive intervention and uncover the possible mechanisms. Participants: Participants were 79 first-year students (aged 17-21) who volunteered for the intervention during the 2016 fall semester. Methods: Participants were randomly assigned into the intervention group and the control group. All participants completed pretest, post-test, 1 week, and 3-month follow-up tests. Thriving, negative emotional states, strengths knowledge were assessed. Results: Results showed significant increases of thriving in the intervention group at post-test and after 1 week, and significant decreases of negative emotions at the post-test and after 1 week and 3 months. Strengths knowledge fully mediated the intervention effect on thriving at post-test. Conclusions: The single-session positive cognitive intervention could be a responsive and effective approach to promote first-year students mental health. More attention should be paid to mechanisms of the single-session positive cognitive intervention so as to optimize the effects of the single-session positive cognitive intervention.",2019,"RESULTS Results showed significant increases of thriving in the intervention group at post-test and after 1 week, and significant decreases of negative emotions at the post-test and after 1 week and 3 months.","['Participants were 79 first-year students (aged 17-21) who volunteered for the intervention during the 2016 fall semester', ""first-year students' mental health"", 'Participants']",['single-session positive cognitive intervention'],"['negative emotions', 'Thriving, negative emotional states, strengths knowledge']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0366704,"RESULTS Results showed significant increases of thriving in the intervention group at post-test and after 1 week, and significant decreases of negative emotions at the post-test and after 1 week and 3 months.","[{'ForeName': 'He', 'Initials': 'H', 'LastName': 'Bu', 'Affiliation': 'a Department of Sociology, , Wuhan University, Wuhan , Hubei , China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': 'a Department of Sociology, , Wuhan University, Wuhan , Hubei , China.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2018.1497639'] 204,32044040,"Letter to the Editor Re: ""The Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial"".",,2020,,[],['Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation'],['Recovery'],[],"[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]",[],,0.109802,,"[{'ForeName': 'Sung Ho', 'Initials': 'SH', 'LastName': 'Jang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Yeungnam University, Gyeongsang, South Korea.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.011'] 205,32313830,TRanscranial AlterNating current Stimulation FOR patients with Mild Alzheimer's Disease (TRANSFORM-AD study): Protocol for a randomized controlled clinical trial.,"Introduction Recently, transcranial alternating current stimulation (tACS), which can interact with ongoing neuronal activity, has emerged as a potentially effective and promising treatment for Alzheimer's disease (AD), and the 40 Hz gamma frequency was suggested as a suitable stimulation frequency for AD. Methods The TRANSFORM-AD study is a double-blind, randomized-controlled trial that will include 40 individuals with mild AD. Eligible patients need to have amyloid β (Aβ) loads examined by Pittsburgh compound B (PiB) positron emission tomography (PET) or decreased Aβ level in cerebrospinal fluid. Participants will be randomized into either a 40 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). The outcome measures will be assessed at baseline, at the end of the intervention, and 3 months after the first session. The primary outcome is global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), and the secondary outcomes include changes in other neuropsychological assessments and in PiB-PET, structural magnetic resonance imaging (MRI), resting electroencephalography (EEG), and simultaneous EEG-functional MRI (EEG-fMRI) results. Results The trial is currently ongoing, and it is anticipated that recruitment will be completed in June 2021. Discussion This trial will evaluate the efficacy and safety of 40 Hz tACS in patients with AD, and further explore the potential mechanisms by analyzing amyloid deposits using PiB-PET, brain volume and white matter integrity by structural MRI, and neural activity by EEG and EEG-fMRI.",2020,"The outcome measures will be assessed at baseline, at the end of the intervention, and 3 months after the first session.","[""patients with Mild Alzheimer's Disease (TRANSFORM-AD study"", '40 individuals with mild AD', '40', 'patients with AD', 'Eligible patients need to have amyloid β (Aβ) loads examined by Pittsburgh compound B (PiB) positron emission tomography (PET) or decreased Aβ level in cerebrospinal fluid']","['Hz tACS', '40\xa0Hz tACS group or a sham stimulation group', 'transcranial alternating current stimulation (tACS', 'TRanscranial AlterNating current Stimulation FOR']","[""global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), and the secondary outcomes include changes in other neuropsychological assessments and in PiB-PET, structural magnetic resonance imaging (MRI), resting electroencephalography (EEG), and simultaneous EEG-functional MRI (EEG-fMRI) results"", 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.443861,"The outcome measures will be assessed at baseline, at the end of the intervention, and 3 months after the first session.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}, {'ForeName': 'Penghu', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': 'Department of Neurosurgery Xuanwu\xa0Hospital Capital Medical University Beijing China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery Xuanwu\xa0Hospital Capital Medical University Beijing China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shan', 'Affiliation': 'Department of Radiology Xuanwu\xa0Hospital Capital Medical University Beijing China.'}, {'ForeName': 'Yueying', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}, {'ForeName': 'Beijia', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}, {'ForeName': 'Zhongfang', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology Xuanwu\xa0Hospital Capital Medical University Beijing China.'}, {'ForeName': 'Guoguang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery Xuanwu\xa0Hospital Capital Medical University Beijing China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12005'] 206,31641214,Preoperative liking and wanting for sweet beverages as predictors of body weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy.,"BACKGROUND/OBJECTIVES Patients who receive Roux-en-Y gastric bypass (RYGB) lose more weight than those who receive vertical sleeve gastrectomy (VSG). RYGB and VSG alter hedonic responses to sweet flavor, but whether baseline differences in hedonic responses modulate weight loss after RYGB or VSG remains untested. PARTICIPANTS/METHODS Male and female candidates (n = 66) for RYGB or VSG were recruited and tested for their subjective liking and wanting ratings of sucrose solutions and flavored beverages sweetened with aspartame. Participants were classified by unsupervised hierarchical clustering for their liking and wanting ratings of sucrose and aspartame. Participant liking ratings were also used in a supervised classification using pre-established categories of liking ratings (liker, disliker, and inverted u-shape). Effects of categories obtained from unsupervised or supervised classification on body weight loss and their interaction with surgery type were analyzed separately at 3 and 12 months after surgery using linear models corrected for sex and age. RESULTS RYGB participants lost more body weight compared with VSG participants at 3 and 12 months after surgery (P < 0.001 for both time points). Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame. RYGB participants in high-wanting clusters based on sucrose, but not aspartame, lost more weight than VSG at both 3 (P = 0.01) and 12 months (P = 0.03), yielding a significant cluster by surgery interaction. Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants. CONCLUSIONS Classification of patients into high/low-wanting ratings for sucrose before surgery can predict differential body weight loss after RYGB or VSG in adults and could be used to advise on surgery type.",2020,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants. ","['Patients who receive', 'Male and female candidates (n\u2009=\u200966) for RYGB or VSG']","['Roux-en-Y gastric bypass and sleeve gastrectomy', 'Preoperative liking and wanting for sweet beverages', 'RYGB and VSG', 'Roux-en-Y gastric bypass (RYGB', 'vertical sleeve gastrectomy (VSG', 'sucrose solutions and flavored beverages sweetened with aspartame', 'Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame']","['Participant liking ratings', 'body weight', 'body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0158572,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants. ","[{'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Perez-Leighton', 'Affiliation': 'Department of Physiology, School of Biological Sciences, Pontificia Universidad Católica, Santiago, Chile.'}, {'ForeName': 'Jeon D', 'Initials': 'JD', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Shoran', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Albu', 'Affiliation': ""Mt. Sinai St. Luke's Hospital, New York, NY, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'NutriSci Incorporated, Mt. Kisco, NY, USA.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Kissileff', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA. Harry.Kissileff2@mountsinai.org.'}]",International journal of obesity (2005),['10.1038/s41366-019-0474-1'] 207,31794974,One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.,"Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p < 0.05). In summary, greater accumulated exposure to active iTBS demonstrated clinically meaningful improvements in the year following stimulation, and default mode connectivity could be used to predict longer-term outcomes.",2020,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","['post-traumatic stress disorder (PTSD', 'Mean age was 51.0\u2009±\u200912.3 years and seven (15.2%) were female', 'fifty veterans with PTSD', ""Forty-six (92%) of the initial study's intent-to-treat participants were included""]","['total of 4-weeks of active iTBS', 'active iTBS (4-weeks active iTBS', 'theta burst stimulation', 'active intermittent TBS (iTBS', 'Theta burst transcranial magnetic stimulation (TBS', 'TMS']","['clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS', 'Mean days to relapse']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",50.0,0.149203,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrosino', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': ""Mascha van 't"", 'Initials': ""MV'"", 'LastName': 'Wout-Frank', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zandvakili', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA. noah_philip@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0584-4'] 208,31802278,The influence of irrigation fluid temperature on recurrence in the evacuation of chronic subdural hematoma.,"BACKGROUND Chronic subdural hematomas (cSDH) are one of the most common conditions requiring neurosurgical treatment. The reported recurrence after surgery is 3-21.5% with closed system drainage. In clinical practice, irrigation fluids at body temperature (37 °C) and at room temperature (22 °C) are routinely used in the evacuation of cSDH. Our hypothesis was that irrigation at body temperature might have more beneficial effects on coagulation and solubility of the chronic subdural hematoma than irrigation at room temperature. The aim of this study was to compare the effects of different intraoperative irrigation fluid temperatures on recurrence rates. METHODS This was a retrospective study where we included all consecutive patients from a defined geographical area of western Sweden between September 2013 and November 2014. In the course of 6 months, we performed intraoperative irrigation at body temperature (37 °C, BT-group) during burr hole evacuation of chronic subdural hematoma. This was then compared with the previous 6-month period, when irrigation fluid at room temperature (22 °C, RT-group) was used. The primary endpoint was same-sided recurrence in need of reoperation within 6 months. RESULTS Recurrence occurred in 11 of 84 (13.1%) patients in the RT-group compared with 4 of 88 (4.5%) in the BT-group (p = 0.013). There were no significant between-group differences regarding age, sex, duration of surgery, frequency of bilateral hematomas, hematoma density, and use of anticoagulant/antithrombotic therapy. CONCLUSION Our study demonstrates that intraoperative irrigation fluid at body temperature is associated with lower recurrence rates compared with irrigation fluid at room temperature. To investigate this further, a prospective randomized controlled trial has been initiated (clinicaltrials.gov, NCT0275235). TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0275235.",2020,"There were no significant between-group differences regarding age, sex, duration of surgery, frequency of bilateral hematomas, hematoma density, and use of anticoagulant/antithrombotic therapy. ","['all consecutive patients from a defined geographical area of western Sweden between September 2013 and November 2014', 'chronic subdural hematoma', 'Chronic subdural hematomas (cSDH']","['intraoperative irrigation at body temperature (37', 'irrigation fluid temperature']","['recurrence rates', 'age, sex, duration of surgery, frequency of bilateral hematomas, hematoma density, and use of anticoagulant/antithrombotic therapy', 'Recurrence', 'same-sided recurrence in need of reoperation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C2746010', 'cui_str': 'Irrigating solution'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}]",,0.0951389,"There were no significant between-group differences regarding age, sex, duration of surgery, frequency of bilateral hematomas, hematoma density, and use of anticoagulant/antithrombotic therapy. ","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bartley', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Blå stråket 5, 41345, Gothenburg, Sweden. andreas.bartley@vgregion.se.'}, {'ForeName': 'Asgeir S', 'Initials': 'AS', 'LastName': 'Jakola', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Blå stråket 5, 41345, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Tisell', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Blå stråket 5, 41345, Gothenburg, Sweden.'}]",Acta neurochirurgica,['10.1007/s00701-019-04150-6'] 209,30371101,A modeling-based narrative intervention to promote timely care-seeking in patients with acute myocardial infarction: A pilot randomized controlled trial and feasibility analysis.,"BACKGROUND Prolonged delay in seeking medical attention for acute myocardial infarction persists as a global phenomenon, which limits effective disease management. The effects of previous mass-media campaigns and psycho-educations have been minimal. AIMS This study aimed to develop a modeling-based narrative intervention, and to examine its feasibility and preliminary effects on care-seeking behavioral intention in Chinese acute myocardial infarction patients. METHODS The modeling-based narrative intervention was developed by integrating updated research evidence and participants' perspectives. Ten patients were invited to co-design the intervention. The narrative approach was adopted to engage patients in a mental rehearsal of the decision-making process through a virtual acute myocardial infarction attack experience. A pilot randomized controlled trial was adopted to examine the feasibility and preliminary effects of this intervention. RESULTS A total of 67 participants were randomly allocated to receive either the modeling-based narrative intervention ( n=34) or didactic education ( n=33). The intervention was feasible and well-accepted by the participants as evidenced by high attendance and participant satisfaction. They considered the intervention as informative and interesting. The majority of the participants in the intervention group expressed that they enjoyed the intervention. Although the preliminary data showed non-significant between-group differences, a more prominent improving trend for acute myocardial infarction knowledge, care-seeking attitudes and beliefs in the intervention group were evident. CONCLUSIONS This study is the first of its kind to adopt a novel narrative approach to optimize care-seeking behaviors among patients with acute myocardial infarction. The preliminary findings showed that this approach was highly feasible and accepted by patients.",2019,"Although the preliminary data showed non-significant between-group differences, a more prominent improving trend for acute myocardial infarction knowledge, care-seeking attitudes and beliefs in the intervention group were evident. ","['patients with acute myocardial infarction', 'Chinese acute myocardial infarction patients', '67 participants']","['modeling-based narrative intervention ( n=34) or didactic education', 'care-seeking behavioral intention', 'A modeling-based narrative intervention']","['acute myocardial infarction knowledge, care-seeking attitudes and beliefs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",67.0,0.0383976,"Although the preliminary data showed non-significant between-group differences, a more prominent improving trend for acute myocardial infarction knowledge, care-seeking attitudes and beliefs in the intervention group were evident. ","[{'ForeName': 'Polly Wc', 'Initials': 'PW', 'LastName': 'Li', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Doris Sf', 'Initials': 'DS', 'LastName': 'Yu', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118810126'] 210,30529451,A computerized decision support tool to implement asthma guidelines for children and adolescents.,"BACKGROUND Multicenter randomized controlled trials (RCTs) for asthma management that incorporate usual-care regimens could benefit from standardized application of evidence-based guidelines. OBJECTIVE We sought to evaluate performance of a computerized decision support tool, the Asthma Control Evaluation and Treatment (ACET) Program, to standardize usual-care regimens for asthma management in RCTs. METHODS Children and adolescents with persistent uncontrolled asthma living in urban census tracts were recruited into 3 multicenter RCTs (each with a usual-care arm) between 2004 and 2014. A computerized decision support tool scored asthma control and assigned an appropriate treatment step based on published guidelines. Control-level determinants (symptoms, rescue medication use, pulmonary function measure, and adherence estimates) were collected at visits and entered into the ACET Program. Changes in control levels and treatment steps were examined during the trials. RESULTS At screening, more than half of the participants were rated as having symptoms that were not controlled or poorly controlled. The proportion of participants who gained good control between screening and randomization increased significantly in all 3 trials. Between 51% and 70% had symptoms that were well controlled by randomization. The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit. Nighttime symptoms were the most common control-level determinant; there were few (<1%) instances of complete overlap of factors. FEV 1 was the driver of control-level assignment in 30% of determinations. CONCLUSION The ACET Program decision support tool facilitated standardized asthma assessment and treatment in multicenter RCTs and was associated with attaining and maintaining good asthma control in most participants.",2019,The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit.,"['Children and adolescents with persistent uncontrolled asthma living in urban census tracts were recruited into 3 multicenter RCTs (each with a usual-care arm) between 2004 and 2014', 'children and adolescents', 'asthma management in RCTs']",['Asthma Control Evaluation and Treatment (ACET) Program'],"['Nighttime symptoms', 'Control-level determinants (symptoms, rescue medication use, pulmonary function measure, and adherence estimates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0007663', 'cui_str': 'Censuses'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0948677,The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit.,"[{'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Kercsmar', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: carolyn.kercsmar@cchmc.org.""}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Department of Medicine, Division of Allergy and Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Calatroni', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gergen', 'Affiliation': 'Division of Allergy, Immunology, and Transplantation, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bloomberg', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Gruchalla', 'Affiliation': 'Department of Internal Medicine/Pediatrics, Division of Allergy and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Pulmonology, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatrics, Division of Pulmonary Medicine, Children's Hospital Colorado, Aurora, Colo.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Sleep and Critical Care Medicine, Boston University School of Medicine, Boston, Mass.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Department of Pediatrics, Division of Allergy and Immunology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.""}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': 'Department of Pediatrics, Division of Pulmonary Medicine, National Jewish Health and University of Colorado, Denver School of Medicine, Denver, Colo.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine and Trauma Services, Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Wildfire', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Zoratti', 'Affiliation': 'Department of Pediatrics, Division of Allergy and Immunology, Henry Ford Health System and Wayne State University School of Medicine, Detroit, Mich.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Department of Medicine, Division of Allergy and Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.10.060'] 211,32297945,Effect of Treatment Expectation on Placebo Response and Analgesic Efficacy: A Secondary Aim in a Randomized Clinical Trial.,,2020,,[],[],['Placebo Response and Analgesic Efficacy'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.420829,,"[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Sanders', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Slade', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ohrbach', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University at Buffalo, State University of New York, Buffalo.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Arbes', 'Affiliation': 'Rho Inc, Durham, North Carolina.'}, {'ForeName': 'Inna E', 'Initials': 'IE', 'LastName': 'Tchivileva', 'Affiliation': 'Division of Oral and Craniofacial Health Sciences, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2907'] 212,31427252,"Efficacy of oral amoxicillin-clavulanate or azithromycin for non-severe respiratory exacerbations in children with bronchiectasis (BEST-1): a multicentre, three-arm, double-blind, randomised placebo-controlled trial.","BACKGROUND Bronchiectasis guidelines recommend antibiotics for the treatment of acute respiratory exacerbations, but randomised placebo-controlled trials in children are lacking. We hypothesised that oral amoxicillin-clavulanate and azithromycin would each be superior to placebo in achieving symptom resolution of non-severe exacerbations in children by day 14 of treatment. METHODS In this multicentre, three-arm, parallel, double-dummy, double-blind, randomised placebo-controlled trial at four paediatric centres in Australia and New Zealand, we enrolled children aged 1-18 years with CT-confirmed bronchiectasis unrelated to cystic fibrosis, who were under the care of a respiratory physician and who had had at least two respiratory exacerbations in the 18 months before study entry. Participants were allocated (1:1:1) at exacerbation onset to receive oral suspensions of amoxicillin-clavulanate (45 mg/kg per day) plus placebo azithromycin, azithromycin (5 mg/kg per day) plus placebo amoxicillin-clavulanate, or both placebos for 14 days. An independent statistician prepared a computer-generated, permuted-block (size 2-8) randomisation sequence, stratified by centre, age, and cause. Participants, caregivers, study coordinators, and investigators were masked to treatment assignment until data analysis was completed. The primary outcome was the proportion of children with exacerbation resolution by day 14 in the intention-to-treat population. Treatment groups were compared using generalised linear models. Statistical significance was set at p<0·0245 to account for multiple comparisons. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000011886) and is completed. FINDINGS Between April 17, 2012, and March 1, 2017, 604 children were screened and 252 were enrolled. Between July 31, 2012, and June 26, 2017, 197 children were allocated at the start of an exacerbation (63 to the amoxicillin-clavulanate group, 67 to the azithromycin group, and 67 to the placebo group). Respiratory viruses were identified in 82 (53%) of 154 children with available nasal swabs on day 1 of treatment. Primary outcome data were available for 196 (99%) children (one child with missing data [placebo group] was recorded as non-resolved according to criteria defined a priori). By day 14, exacerbations had resolved in 41 (65%) children in the amoxicillin-clavulanate group, 41 (61%) in the azithromycin group, and 29 (43%) in the placebo group. Compared with placebo, relative risk for resolution by day 14 was 1·50 (95% CI 1·08-2·09, p=0·015; number-needed-to-treat [NNT] 5 [95% CI 3-20]) in the amoxicillin-clavulanate group and 1·41 (1·01-1·97, p=0·042; NNT 6 [3-79]) in the azithromycin group. Adverse events were recorded in 19 (30%) children in the amoxicillin-clavulanate group, 20 (30%) in the azithromycin group, and 14 (21%) in the placebo group, but no events were severe or life-threatening. INTERPRETATION Amoxicillin-clavulanate treatment is beneficial in terms of resolution of non-severe exacerbations of bronchiectasis in children, and should remain the first-line oral antibiotic in this setting. FUNDING National Health and Medical Research Council (Australia), Cure Kids (New Zealand).",2019,Respiratory viruses were identified in 82 (53%) of 154 children with available nasal swabs on day 1 of treatment.,"['154 children with available nasal swabs on day 1 of treatment', 'controlled trial at four paediatric centres in Australia and New Zealand, we enrolled children aged 1-18 years with CT-confirmed bronchiectasis unrelated to cystic fibrosis, who were under the care of a respiratory physician and who had had at least two respiratory exacerbations in the 18 months before study entry', 'Between April 17, 2012, and March 1, 2017, 604 children were screened and 252 were enrolled', 'children with bronchiectasis (BEST-1', 'Between July 31, 2012, and June 26, 2017, 197 children were allocated at the start of an exacerbation (63 to the']","['placebo', 'placebo azithromycin, azithromycin', 'amoxicillin-clavulanate', 'amoxicillin-clavulanate and azithromycin', 'amoxicillin', 'oral suspensions of amoxicillin-clavulanate', 'azithromycin', 'oral amoxicillin-clavulanate or azithromycin', 'placebo amoxicillin-clavulanate, or both placebos', 'Amoxicillin-clavulanate treatment']","[' number-needed-to-treat [NNT', 'Adverse events', 'proportion of children with exacerbation resolution', 'severe or life-threatening']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologists'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0110038', 'cui_str': 'Clavulanate'}, {'cui': 'C0991537', 'cui_str': 'Oral Suspension'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",604.0,0.726983,Respiratory viruses were identified in 82 (53%) of 154 children with available nasal swabs on day 1 of treatment.,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Goyal', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia; Department of Paediatrics, Gold Coast Health, Gold Coast, QLD, Australia; School of Medicine, The University of Queensland Brisbane, QLD, Australia; Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia. Electronic address: drvikasgoyal@gmail.com.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Grimwood', 'Affiliation': 'Department of Paediatrics, Gold Coast Health, Gold Coast, QLD, Australia; Department of Infectious Diseases, Gold Coast Health, Gold Coast, QLD, Australia; School of Medicine, Griffith University, Gold Coast, QLD, Australia; Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Byrnes', 'Affiliation': ""Department of Paediatrics, University of Auckland, Auckland, New Zealand; Respiratory Department, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Morris', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia; Department of Paediatrics, Royal Darwin Hospital, Darwin, NT, Australia.'}, {'ForeName': 'I Brent', 'Initials': 'IB', 'LastName': 'Masters', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia; Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia.""}, {'ForeName': 'Gabrielle B', 'Initials': 'GB', 'LastName': 'McCallum', 'Affiliation': 'Child Health Division, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Binks', 'Affiliation': 'Child Health Division, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'School of Medicine, Griffith University, Gold Coast, QLD, Australia; Child Health Division, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Kerry-Ann F', 'Initials': 'KF', 'LastName': ""O'Grady"", 'Affiliation': ""Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Champion', 'Affiliation': ""Pharmacy Department, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Buntain', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schultz', 'Affiliation': ""Telethon Kids Institute, Perth, WA, Australia; Division of Paediatrics, School of Medicine, University of Western Australia, Perth, WA, Australia; Department of Respiratory and Sleep Medicine, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chatfield', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, The University of Queensland Brisbane, QLD, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Central Clinical School, University of Sydney, Sydney, NSW, Australia; Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia; Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia; Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.""}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30254-1'] 213,31995812,Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment.,"Major depressive disorder (MDD) is associated with altered global brain connectivity (GBC), as assessed via resting-state functional magnetic resonance imaging (rsfMRI). Previous studies found that antidepressant treatment with ketamine normalized aberrant GBC changes in the prefrontal and cingulate cortices, warranting further investigations of GBC as a putative imaging marker. These results were obtained via global signal regression (GSR). This study is an independent replication of that analysis using a separate dataset. GBC was analyzed in 28 individuals with MDD and 22 healthy controls (HCs) at baseline, post-placebo, and post-ketamine. To investigate the effects of preprocessing, three distinct pipelines were used: (1) regression of white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF + GSR (GSR); and (3) WM/CSF + physiological parameter regression (PHYSIO). Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal. Ketamine had no effect compared to baseline or placebo in either group in any pipeline. PHYSIO did not resemble GBC preprocessed with GSR. These results concur with several studies that used GSR to study GBC. Further investigations are warranted into disease-specific components of global fMRI signals that may drive these results and of GBCr as a potential imaging marker in MDD.",2020,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","['Major depressive disorder (MDD', '28 individuals with MDD and 22 healthy controls (HCs) at baseline, post']","['placebo', 'Ketamine', 'placebo-controlled ketamine', 'ketamine', 'white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF\u2009+\u2009GSR (GSR); and (3) WM/CSF\u2009+\u2009physiological parameter regression (PHYSIO']","['GBC', 'Reduced GBC']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",28.0,0.0521611,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. christoph.kraus@nih.gov.'}, {'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0624-0'] 214,31995813,"Modafinil enhances cognitive, but not emotional conflict processing via enhanced inferior frontal gyrus activation and its communication with the dorsomedial prefrontal cortex.","Cognitive control regulates cognitive and emotional systems to facilitate goal-directed behavior in the context of task-irrelevant distractors. Cognitive control deficits contribute to residual functional impairments across psychiatric disorders and represent a promising novel treatment target. Translational evidence suggests that modafinil may enhance performance in executive functions; however, differential effects on regulatory control in cognitive and emotional domains have not been examined. The present pre-registered randomized-controlled pharmacological fMRI trial examined differential effects of modafinil (single-dose, 200 mg) on cognitive and emotional conflict processing. To further separate objective cognitive enhancing effects from subjective performance perception, a metacognitive paradigm was employed. Results indicated that modafinil specifically enhanced cognitive conflict performance and concomitantly increased activation in the inferior frontal gyrus and its functional communication with the dorsomedial prefrontal cortex. Exploratory analysis further revealed modafinil-enhanced basolateral amygdala reactivity to cognitive conflict, with stronger reactivity being associated with higher cognitive conflict performance. Whereas modafinil enhanced cognitive performance in the metacognitive paradigm, confidence indices remained unaffected. Overall, the present results suggest that modafinil has the potential to enhance cognitive conflict processing while leaving emotional conflict processing unaffected. On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information. The pattern of cognitive enhancing effects in the absence of effects on affective processing suggests a promising potential to enhance cognitive control in clinical populations.",2020,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.",[],"['Modafinil', 'modafinil']","['cognitive performance', 'cognitive and emotional conflict processing', 'cognitive conflict performance']",[],"[{'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0288783,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.","[{'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Daumann', 'Affiliation': 'LVR Clinics of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Daumann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. ben_becker@gmx.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0625-z'] 215,32092760,Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin.,"Twenty-four hours after administration, ketamine exerts rapid and robust antidepressant effects that are thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. Twenty patients suffering a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo 2 h prior to the intravenous administration of ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS). Rapamycin pretreatment did not alter the antidepressant effects of ketamine at the 24-h timepoint. Over the subsequent 2-weeks, we found a significant treatment by time interaction (F (8,245)  = 2.02, p = 0.04), suggesting a prolongation of the antidepressant effects of ketamine by rapamycin. Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively). In summary, single dose rapamycin pretreatment failed to block the antidepressant effects of ketamine, but it prolonged ketamine's antidepressant effects. This observation raises questions about the role of systemic vs. local blockade of mTORC1 in the antidepressant effects of ketamine, provides preliminary evidence that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that contribute to depression relapse after ketamine administration.",2020,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).",['Twenty patients suffering a major depressive episode'],"['rapamycin\u2009+\u2009ketamine', 'placebo', 'ketamine', 'Rapamycin', 'rapamycin', 'placebo\u2009+\u2009ketamine', 'rapamycin, an mTORC1 inhibitor, prior to receiving ketamine', 'oral rapamycin']","['remission rates', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0810233,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@yale.edu.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Formica', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0644-9'] 216,32318749,The effect of dexmedetomidine on spinal anesthesia quality and hemodynamic changes in patients undergoing inguinal hernia repair surgery: intravenous versus intrathecal.,"PURPOSE The aim of this study was to evaluate the quality of spinal anesthesia and hemodynamic parameters of intravenous versus intrathecal dexmedetomidine in patients undergoing inguinal hernia repair surgery under spinal anesthesia. METHODS Fifty male patients aged 18-70 years with ASA I and II were randomly divided into two groups of 25 patients receiving either intravenous (1 μg/kg infused during 10 min before blockade) or intrathecal (5 μg, added to local anesthetics) dexmedetomidine. The duration of analgesia, sensory and motor blockade levels, the score of pain intensity, post-operative analgesic usage and the level of sedation as well as hemodynamic changes, and complications were recorded. RESULTS The duration of analgesia in the intrathecal group was significantly longer than intravenous group (403.588 ± 93.706 vs. 274.048 ± 47.266 min; P < 0.001). Duration of the sensory and motor blockade were significantly longer in intrathecal than intravenous group (230.440 ± 26.494 vs. 181.400 ± 28.850 min; P < 0.001 for sensory block, and 253.800 ± 32.637 vs. 205.400 ± 30.921 min; P < 0.001 for motor block). The score of pain intensity was lower in the intrathecal group in the post-operative period (3.680 ± 1.680 vs. 5.520 ± 1.901; P = 0.001 and 2.360 ± 1.320 vs. 3.24 ± 1.69; P = 0.041, respectively, for the time 6 and 12). Ramsay sedation score was higher in the intravenous group during surgery but it was higher in intrathecal group during recovery room period (P < 0.05). Moreover, the incidence of bradycardia was significantly lower in the intrathecal group (0% vs. 36% respectively; P = 0.002). CONCLUSION Administration of intrathecal dexmedetomidine along with local anesthetics can be recommended to increase the quality of spinal anesthesia with minimal complications.",2020,Ramsay sedation score was higher in the intravenous group during surgery but it was higher in intrathecal group during recovery room period (P < 0.05).,"['Fifty male patients aged 18-70\xa0years with ASA I and II were randomly divided into two groups of 25 patients receiving either', 'patients undergoing inguinal hernia repair surgery', 'patients undergoing inguinal hernia repair surgery under spinal anesthesia']","['dexmedetomidine', 'intrathecal dexmedetomidine', 'intravenous (1\xa0μg/kg infused during 10\xa0min before blockade) or intrathecal (5\xa0μg, added to local anesthetics) dexmedetomidine']","['duration of analgesia, sensory and motor blockade levels, the score of pain intensity, post-operative analgesic usage and the level of sedation as well as hemodynamic changes, and complications', 'spinal anesthesia quality and hemodynamic changes', 'score of pain intensity', 'duration of analgesia', 'Ramsay sedation score', 'incidence of bradycardia', 'quality of spinal anesthesia', 'Duration of the sensory and motor blockade']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}]",50.0,0.109677,Ramsay sedation score was higher in the intravenous group during surgery but it was higher in intrathecal group during recovery room period (P < 0.05).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Khosravi', 'Affiliation': 'Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Sadeghi', 'Affiliation': 'Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Jarineshin', 'Affiliation': 'Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. hjarineshin@yahoo.com.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02870-8'] 217,32298270,Sensory focused exercise improves anxiety in Parkinson's disease: A randomized controlled trial.,"Anxiety has been implicated as one of the greatest influences on quality of life in Parkinson's disease (PD). The etiology of anxiety is unclear, although previous work suggests that anxiety may be linked to sensory deficits that cause uncertainty in movement. Thus, the current study examined whether focusing attention on sensory feedback during goal-based exercise has the potential to provide benefits to anxiety in PD. Thirty-five participants with PD were randomized to either a Sensory Attention Focused Exercise (SAFEx) (i.e. internal focus of attention, n = 18) or Sham Exercise control (i.e. external focus of attention, n = 17) and completed 33 one-hour attention-based exercise sessions over 11-weeks. Before and after the program (pre and post), participants completed the Parkinson Anxiety Scale (PAS) questionnaire. The PAS includes three anxiety sections: persistent, episodic, and avoidance. Changes in the total PAS score and within each section of the PAS were subjected to two-factor mixed repeated measures ANCOVA. Significant group by time interactions demonstrated that from pre to post, total PAS scores (p = 0.007) and episodic anxiety scores (p = 0.010) significantly decreased in the SAFEx group only (ΔTotal PAS = -5.2, F(1,27) = 5.41, p = 0.028, ηp2 = 0.17; ΔEpisodic Score = -1.8, F(1,27) = 6.89, p = 0.014, ηp2 = 0.20). In conclusion, focusing attention on sensory feedback while completing goal-based exercises may provide significant benefits to improving anxiety in PD. As such, sensory attention focused exercise may be a critical adjunct therapy for improving anxiety, and ultimately quality of life in people with PD.",2020,"Significant group by time interactions demonstrated that from pre to post, total PAS scores (p = 0.007) and episodic anxiety scores (p = 0.010) significantly decreased in the SAFEx group only (ΔTotal PAS = -5.2, F(1,27) =","[""Parkinson's disease"", 'people with PD', 'Thirty-five participants with PD']","['Sensory focused exercise', 'Sensory Attention Focused Exercise (SAFEx) (i.e. internal focus of attention, n = 18) or Sham Exercise control (i.e. external focus of attention, n = 17) and completed 33 one-hour attention-based exercise sessions']","['Parkinson Anxiety Scale (PAS) questionnaire', 'total PAS scores', 'episodic anxiety scores', 'total PAS score']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",35.0,0.065919,"Significant group by time interactions demonstrated that from pre to post, total PAS scores (p = 0.007) and episodic anxiety scores (p = 0.010) significantly decreased in the SAFEx group only (ΔTotal PAS = -5.2, F(1,27) =","[{'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Beck', 'Affiliation': 'School of Medicine, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Mary T Y', 'Initials': 'MTY', 'LastName': 'Wang', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Intzandt', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Quincy J', 'Initials': 'QJ', 'LastName': 'Almeida', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Kaylena A', 'Initials': 'KA', 'LastName': 'Ehgoetz Martens', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0230803'] 218,32315289,Neuroimaging of hypothalamic mechanisms related to glucose metabolism in anorexia nervosa and obesity.,"BACKGROUNDGiven the heightened tolerance to self-starvation in anorexia nervosa (AN), a hypothalamic dysregulation of energy and glucose homeostasis has been hypothesized. Therefore, we investigated whether hypothalamic reactivity to glucose metabolism is impaired in AN.METHODSTwenty-four participants with AN, 28 normal-weight participants, and 24 healthy participants with obesity underwent 2 MRI sessions in a single-blind, randomized, case-controlled crossover study. We used an intragastric infusion of glucose and water to bypass the cephalic phase of food intake. The responsivity of the hypothalamus and the crosstalk of the hypothalamus with reward-related brain regions were investigated using high-resolution MRI.RESULTSNormal-weight control participants displayed the expected glucose-induced deactivation of hypothalamic activation, whereas patients with AN and participants with obesity showed blunted hypothalamic reactivity. Furthermore, patients with AN displayed blunted reactivity in the nucleus accumbens and amygdala. Compared with the normal-weight participants and control participants with obesity, the patients with AN failed to show functional connectivity between the hypothalamus and the reward-related brain regions during water infusion relative to glucose infusion. Finally, the patients with AN displayed typical baseline levels of peripheral appetite hormones during a negative energy balance.CONCLUSIONThese results indicate that blunted hypothalamic glucose reactivity might be related to the pathophysiology of AN. This study provides insights for future research, as it is an extended perspective of the traditional primary nonhomeostatic understanding of the disease.FUNDINGThis study was supported by a grant from the DFG (SI 2087/2-1).",2020,"Compared to normal-weight and obese controls, patients with AN failed to show functional connectivity between the hypothalamus and reward-related brain regions during water relative to glucose.","['Twenty-four participants with AN, 28 normal-weight and 24 healthy participants with obesity underwent 2', 'anorexia nervosa', 'anorexia nervosa and obesity']","['intragastric infusion of glucose and water to bypass the cephalic phase of food intake', 'magnetic resonance imaging (MRI) sessions']","['peripheral appetite hormones', 'glucose-induced deactivation of hypothalamic activation', 'blunted hypothalamic reactivity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",24.0,0.0193325,"Compared to normal-weight and obese controls, patients with AN failed to show functional connectivity between the hypothalamus and reward-related brain regions during water relative to glucose.","[{'ForeName': 'Joe J', 'Initials': 'JJ', 'LastName': 'Simon', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'Stopyra', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mönning', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Sailer', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Lavandier', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Lars P', 'Initials': 'LP', 'LastName': 'Kihm', 'Affiliation': 'Endocrinology and Nephrology, Department of Internal Medicine I, and.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Preissl', 'Affiliation': 'fMEG Center, Helmholtz Center Munich, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Herzog', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Friederich', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}]",The Journal of clinical investigation,['10.1172/JCI136782'] 219,32320285,Dexamethasone Sodium Phosphate Penetration During Phonophoresis at 2 Ultrasound Frequencies.,"CONTEXT The effect of ultrasound frequency on phonophoresis drug delivery in humans is unknown. OBJECTIVE To determine if a low (45-kHz) or high (1-MHz) frequency delivered a higher dexamethasone (Dex) concentration through the skin. DESIGN Controlled laboratory study. SETTING Laboratory. PATIENTS OR OTHER PARTICIPANTS A total of 40 healthy men between the ages of 18 and 45 years (age = 23.1 ± 2.6 years, height = 176.1 ± 7.2 cm, mass = 88.5 ± 19.4 kg, posterior calf subcutaneous thickness measured using musculoskeletal ultrasound imaging = 0.6 ± 0.2 cm). INTERVENTION(S) Participants were randomly assigned to 1 of 4 groups (ultrasound frequency at microdialysis probe depth): (1) 45-kHz frequency at 1 mm, (2) 45-kHz frequency at 4 mm, (3) 1-MHz frequency at 1 mm, or (4) 1-MHz frequency at 4 mm (n = 10 in each group). Three linear microdialysis probes were inserted at the desired tissue depth. We rubbed dexamethasone sodium phosphate (Dex-P) into the skin and then applied a 15-minute phonophoresis treatment. MAIN OUTCOME MEASURE(S) Dialysate was collected during the treatment and 60 minutes posttreatment and analyzed for Dex-P, Dex, and the metabolite form of Dex. The sum of the 3 analytes was calculated as total dexamethasone (Dex-total), and differences between the 45-kHz and 1-MHz treatment groups were determined by a repeated-measures analysis of variance. RESULTS At 1 mm, 3 (30%) participants in the 45-kHz and 4 (40%) participants in the 1-MHz group had measurable levels of Dex-P. Total dexamethasone increased after the treatment ceased, independent of ultrasound frequency (P < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration (P = .006). At 4 mm, 5 (50%) participants in the 45-kHz and 1 (10%) participant in the 1-MHz group had measurable levels of Dex-P. We observed no difference in Dex-total concentration between treatment groups at 4 mm (P = .72). CONCLUSIONS Phonophoresis provided a mechanism for Dex-total delivery at the 1- and 4-mm tissue depths. However, the effectiveness of the ultrasound frequencies varied between the 2 measured tissue depths.",2020,"P < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration ( P = .006).","['40 healthy men between the ages of 18 and 45 years (age = 23.1 ± 2.6 years, height = 176.1 ± 7.2 cm, mass = 88.5 ± 19.4 kg, posterior calf subcutaneous thickness measured using musculoskeletal imaging ultrasound = 0.6 ± 0.2 cm']","['Dexamethasone Sodium Phosphate Penetration', 'low (45-kHz) or high (1-MHz) frequency delivered a higher dexamethasone (Dex', 'dexamethasone sodium phosphate (Dex-P']","['Dialysate', 'measurable levels of Dex-P', 'measurable levels of Dex-P. Total dexamethasone', 'total dexamethasone (Dex-total', 'drug concentration', 'Dex-total concentration', 'ultrasound frequency ']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",40.0,0.0591625,"P < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration ( P = .006).","[{'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Rigby', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hagan', 'Affiliation': 'Texas State University, San Marcos.'}, {'ForeName': 'Austin R', 'Initials': 'AR', 'LastName': 'Kelcher', 'Affiliation': 'Texas State University, San Marcos.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Texas State University, San Marcos.'}]",Journal of athletic training,['10.4085/1062-6050-556-18'] 220,31357206,Pharmacological mechanisms of interhemispheric signal propagation: a TMS-EEG study.,"Interhemispheric connections across the corpus callosum have a predominantly inhibitory effect. Previous electrophysiology studies imply that local inhibitory circuits are responsible for inducing transcallosal inhibition, likely through inhibitory GABA B -mediated neurotransmission. We investigated the neurochemical mechanisms involved in interhemispheric connectivity by measuring transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP) in the motor cortex and dorsolateral prefrontal cortex (DLPFC) with electroencephalography (EEG) recordings under the pharmacological effects of baclofen, L-DOPA, dextromethorphan, and rivastigmine. We hypothesized that for both stimulated regions, GABA B receptor agonist baclofen would decrease ISP when compared against baseline while drugs that target other neurotransmitter systems (dopaminergic, acetylcholinergic, and glutamatergic systems) would have no effect on ISP. Twelve right-handed healthy volunteers completed this study and underwent TMS across five sessions in a randomized order. In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions. There were no drug-induced changes in ISP in the DLPFC and baseline ISP did not differ across experimental sessions for both brain regions. Together, our results suggest that the inhibitory effects observed with interhemispheric signal transmission are mediated by a population of interneurons involving GABA B receptor neurotransmission. Inhibitory mechanisms of ISP may be more salient for motor-related functions in the motor cortex than for cognitive control in the DLPFC. These findings are a fundamental step in advancing our understanding of interhemispheric connectivity and may be used to identify treatments for disorders in which transcallosal transmission is dysfunctional.",2020,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.",['Twelve right-handed healthy volunteers'],"['baclofen, L-DOPA, dextromethorphan, and rivastigmine', 'TMS', 'transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP']","['ISP under baclofen', 'ISP']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}]",12.0,0.0545946,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Lioumis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Salavati', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0468-7'] 221,31567357,Povidone-iodine Irrigation for Pediatric Perforated Appendicitis May Be Protective: A Bayesian Pilot Randomized Controlled Trial.,"OBJECTIVES A randomized controlled trial was conducted to test the hypothesis that povidone-iodine (PVI) irrigation versus no irrigation (NI) reduces postoperative intra-abdominal abscess (IAA) in children with perforated appendicitis. METHODS A 100 patient pilot randomized controlled trial was conducted. Consecutive patients with acute perforated appendicitis were randomized (1:1) to PVI or NI from April 2016 to March 2017 and followed for 1 year. Patients and postoperative providers were blinded to allocation. The primary endpoint was 30-day image-confirmed IAA. Secondary outcomes included initial and total 30-day length of stay (LOS), emergency department (ED) visits, and readmissions. Intention-to-treat analyses were performed to estimate the probability of clinical benefit using Bayesian regression models (an optimistic prior for the primary outcome and neutral priors for secondary outcomes). Frequentist statistics were also used. RESULTS Baseline characteristics were similar between treatment arms. The PVI arm had 12% postoperative IAA versus 16% in the NI arm (relative risk 0.72, 95% credible interval 0.38-1.23). Bayesian analysis estimates 89% probability that PVI reduces IAA. High probability of benefit was seen in all secondary outcomes for the PVI arm: fewer ED visits and readmissions, and shorter initial and total 30-day LOS. The probability of benefit in reduction of total 30-day LOS in PVI patients was 96% and was significant (P = 0.05) on frequentist analysis. CONCLUSIONS PVI irrigation for perforated appendicitis in children demonstrated a strong probability of reduction in postoperative IAA with a high probability of decreased LOS. With the favorable probability of benefit in all outcomes, this pilot study serves as evidence to continue a definitive trial.",2020,"High probability of benefit was seen in all secondary outcomes for the PVI arm: fewer ED visits and readmissions, and shorter initial and total 30-day LOS.","['children with perforated appendicitis', 'Consecutive patients with acute perforated appendicitis', 'Pediatric Perforated Appendicitis']","['povidone-iodine (PVI) irrigation versus no irrigation (NI', 'PVI irrigation', 'Povidone-iodine Irrigation']","['30-day image-confirmed IAA', 'ED visits and readmissions, and shorter initial and total 30-day LOS', 'total 30-day LOS', 'postoperative IAA', 'initial and total 30-day length of stay (LOS), emergency department (ED) visits, and readmissions', 'postoperative intra-abdominal abscess (IAA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0854119', 'cui_str': 'Perforated Appendicitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0274404', 'cui_str': 'Postoperative intra-abdominal abscess (disorder)'}]",,0.324713,"High probability of benefit was seen in all secondary outcomes for the PVI arm: fewer ED visits and readmissions, and shorter initial and total 30-day LOS.","[{'ForeName': 'Kathryn Tinsley', 'Initials': 'KT', 'LastName': 'Anderson', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Luke Randall', 'Initials': 'LR', 'LastName': 'Putnam', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Marisa Angeline', 'Initials': 'MA', 'LastName': 'Bartz-Kurycki', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Emma Catherine', 'Initials': 'EC', 'LastName': 'Hamilton', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yafi', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Mary Thomas', 'Initials': 'MT', 'LastName': 'Austin', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Akemi Lorraine', 'Initials': 'AL', 'LastName': 'Kawaguchi', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Lillian Shiow-Yu', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Kevin Patrick', 'Initials': 'KP', 'LastName': 'Lally', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'KuoJen', 'Initials': 'K', 'LastName': 'Tsao', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}]",Annals of surgery,['10.1097/SLA.0000000000003398'] 222,30277807,Effects of a self-management programme on patient participation in patients with chronic heart failure or chronic obstructive pulmonary disease: A randomized controlled trial.,"BACKGROUND Self-management strategies are crucial to patients with long-term conditions and can presumably promote patient participation, given that to patients, patient participation connotes opportunities for self-care (along with being engaged in an exchange of knowledge, a phrasing of joint goals and planning of care). So far, limited attention has been given to what components support self-management and what outcomes can be achieved. An exclusive self-management programme in primary healthcare entailed assessing its influence on patient participation. AIM To describe the effects of a self-management programme on preferences for, and experiences of, patient participation in patients with chronic obstructive pulmonary disease or chronic heart failure. METHODS A randomized controlled trial with a six session intervention programme, including phrasing of individual action plans and group discussions on the patients' issues. The intervention group ( n=59) received standard care and the self-management programme, and the control group ( n=59) received standard care only. Data was collected at baseline and at three months and 12 months after the intervention started, using the Patient Preferences for Patient Participation (the 4Ps) measure. RESULTS No significant differences were found within the groups, or between the groups, in preferences and experiences of patient participation, either in summary score or at an item level. CONCLUSION A self-management group programme led by trained primary healthcare staff in primary care did not serve as means to influence patients' experience of patient participation in the care of their long-term condition. Further studies are needed in regard to what facilitates patient participation in this setting and beyond.",2019,A self-management group programme led by trained primary healthcare staff in primary care did not serve as means to influence patients' experience of patient participation in the care of their long-term condition.,"['patients with chronic obstructive pulmonary disease or chronic heart failure', 'patients with chronic heart failure or chronic obstructive pulmonary disease']","['standard care and the self-management programme, and the control group ( n=59) received standard care only', 'self-management programme']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.02689,A self-management group programme led by trained primary healthcare staff in primary care did not serve as means to influence patients' experience of patient participation in the care of their long-term condition.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Luhr', 'Affiliation': '1 University Health Care Research Centre, Faculty of Medicine and Health, School of Health Sciences, Örebro University, Sweden.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Eldh', 'Affiliation': '2 Division of Nursing, Department of Medical and Health Sciences, Linköping University, Sweden.'}, {'ForeName': 'Kersti', 'Initials': 'K', 'LastName': 'Theander', 'Affiliation': '4 Centre for Clinical Research, County Council of Värmland, Karlstad, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Holmefur', 'Affiliation': '5 Faculty of Medicine and Health, Örebro University, Sweden.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118804126'] 223,30328701,"Effect of reinforced, targeted in-person education using the Jessa Atrial fibrillation Knowledge Questionnaire in patients with atrial fibrillation: A randomized controlled trial.","BACKGROUND The knowledge level of atrial fibrillation patients about their arrhythmia, its consequences and treatment is poor. The best strategy to provide education is unknown. AIM To investigate the effect of reinforced targeted in-person education using the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ). METHODS Sixty-seven atrial fibrillation patients were randomized to standard care (including brochures) or targeted education. Follow-up visits were scheduled after one, three, six and 12 months. Targeted education during each visit focused on the knowledge gaps revealed by the JAKQ. Patients completed two questionnaires to assess their quality of life and symptom profile. Adherence to non-vitamin K antagonist oral anticoagulants was measured using electronic monitoring. RESULTS Sixty-two patients (31 education; 31 standard care) completed follow-up. Median baseline score on the JAKQ was similar in education (62.5%) and standard care group (56.3%; p=0.815). The intervention group scored significantly better over time (one month: 75.0%, 12 months: 87.5%; p<0.001) whereas there was no significant improvement in the control group (one month: 62.5%, 12 months: 62.5%; p=0.085). Providing targeted education after completion of the JAKQ required on average 6.9±4.6 min. Some improvements in quality of life, symptom burden and adherence were shown, without significant differences between the two groups ( p-values between 0.282 and 0.677). CONCLUSION The JAKQ is an effective tool for providing individualized education. A first targeted educational session significantly improved patients' knowledge level. Additional educational sessions maintained and strengthened this effect. A larger scale study is warranted to evaluate the impact on adherence and outcome measures.",2019,"Some improvements in quality of life, symptom burden and adherence were shown, without significant differences between the two groups ( p-values between 0.282 and 0.677). ","['Sixty-seven atrial fibrillation patients', 'patients with atrial fibrillation']","['JAKQ', 'standard care (including brochures) or targeted education']","['Median baseline score', 'quality of life and symptom profile', 'quality of life, symptom burden and adherence', ""patients' knowledge level""]","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",67.0,0.0672664,"Some improvements in quality of life, symptom burden and adherence were shown, without significant differences between the two groups ( p-values between 0.282 and 0.677). ","[{'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Desteghe', 'Affiliation': '1 Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Engelhard', 'Affiliation': '1 Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vijgen', 'Affiliation': '2 Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Koopman', 'Affiliation': '2 Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Dagmara', 'Initials': 'D', 'LastName': 'Dilling-Boer', 'Affiliation': '2 Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Schurmans', 'Affiliation': '2 Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Delesie', 'Affiliation': '3 University of Antwerp and Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dendale', 'Affiliation': '1 Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbuchel', 'Affiliation': '1 Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118804353'] 224,32303260,Pilot trial of a group cognitive behavioural therapy program for comorbid depression and obesity.,"BACKGROUND Depression and obesity are significant global health concerns that commonly occur together. An integrated group cognitive behavioural therapy program was therefore developed to simultaneously address comorbid depression and obesity. METHODS Twenty-four participants (63% women, mean age 46 years) who screened positively for depression with a body mass index ≥25 were recruited from a self-referred general population sample. The group therapy program (10 two-hour weekly sessions) was examined in a single-arm, before-after pilot trial, conducted in a behavioural health clinic in Adelaide, Australia. Primary outcomes included survey and assessment-based analyses of depression, anxiety, body image, self-esteem, and weight (kg), assessed at four time-points: baseline, post-intervention, three-months and 12-months post program. Eighteen participants (75%) completed the program and all assessments. RESULTS Significant improvements in depression, anxiety, self-esteem and body shape concern scores, several quality of life domains, eating behaviours and total physical activity (among others) - but not weight - were observed over the course of the trial. CONCLUSIONS Results from this pilot trial suggest that combining interventions for depression and obesity may be useful. Further development of the program, particularly regarding the potential for physical health benefits, and a randomised controlled trial, are warranted. TRIAL REGISTRATION Trial registration: ANZCTR, ACTRN12617001079336, 13 July 2017. Retrospectively registered after date of the first consent (6 July 2017), but before the date of the first intervention session (20 July 2017).",2020,"RESULTS Significant improvements in depression, anxiety, self-esteem and body shape concern scores, several quality of life domains, eating behaviours and total physical activity (among others) - but not weight - were observed over the course of the trial. ","['Eighteen participants (75%) completed the program and all assessments', 'comorbid depression and obesity', 'Twenty-four participants (63% women, mean age 46\u2009years) who screened positively for depression with a body mass index ≥25 were recruited from a self-referred general population sample']",['group cognitive behavioural therapy program'],"['survey and assessment-based analyses of depression, anxiety, body image, self-esteem, and weight (kg', 'depression, anxiety, self-esteem and body shape concern scores, several quality of life domains, eating behaviours and total physical activity']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",24.0,0.0722182,"RESULTS Significant improvements in depression, anxiety, self-esteem and body shape concern scores, several quality of life domains, eating behaviours and total physical activity (among others) - but not weight - were observed over the course of the trial. ","[{'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Lores', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, 5001, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Musker', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, 5001, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Collins', 'Affiliation': 'CALHN, Royal Adelaide Hospital, Adelaide, SA, 5000, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Burke', 'Affiliation': 'CALHN, Royal Adelaide Hospital, Adelaide, SA, 5000, Australia.'}, {'ForeName': 'Seth W', 'Initials': 'SW', 'LastName': 'Perry', 'Affiliation': 'College of Medicine, SUNY Upstate Medical University, Syracuse, NY, 13210, USA. PerrySe@upstate.edu.'}, {'ForeName': 'Ma-Li', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'College of Medicine, SUNY Upstate Medical University, Syracuse, NY, 13210, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Licinio', 'Affiliation': 'College of Medicine, SUNY Upstate Medical University, Syracuse, NY, 13210, USA.'}]",BMC psychology,['10.1186/s40359-020-00400-w'] 225,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z'] 226,32250836,"Effect of a brief progressive resistance training program in hospital porters on pain, work ability, and physical function.","BACKGROUND Hospital porters are possibly exposed to the greatest mechanical loads within the hospital environment. However, the evidence about preventive strategies in this population is scarce. OBJECTIVE To investigate the effect of a workplace-based progressive resistance-training program on musculoskeletal pain among hospital porters. METHOD A total of 37 hospital porters (27 women, 10 men) participated. Participants allocated to the intervention group performed five brief resistance training sessions/week, for 9 weeks during working hours at the hospital. Intensity was progressively increased. Participants allocated to the control group maintained their usual physical activity. The primary outcome was pain assessed with the patient global impression of pain change scale. Secondary outcome measures were average pain intensity, work ability, use of analgesics, and physical function. Additionally, perceived general changes were evaluated at follow-up: wellness, satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues. RESULTS For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group. Significant between-group interactions were found for work impairment due to diseases (d = -1.2), hips/thighs pain (d = 0.7), ankles/feet pain (d = 0.4), the Biering-Sorensen test (d = -0.6) and the push-ups test (d = -2.3) favoring the intervention group. All between-group differences were clinically important. CONCLUSION A progressive resistance training program performed at the workplace is feasible and effective in reducing musculoskeletal pain and improving work ability and physical function among hospital porters.",2020,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","['musculoskeletal pain among hospital porters', 'A total of 37 hospital porters (27 women, 10 men) participated']","['workplace-based progressive resistance-training program', 'progressive resistance training program', 'brief resistance training sessions', 'control group maintained their usual physical activity']","['work satisfaction', 'pain assessed with the patient global impression of pain change scale', 'musculoskeletal pain and improving work ability and physical function', 'satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues', 'desire for practicing exercise', 'greater wellbeing', 'average pain intensity, work ability, use of analgesics, and physical function', 'ankles/feet pain', 'hips/thighs pain', 'Intensity', 'pain, work ability, and physical function', 'lower general pain']","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0402674', 'cui_str': 'Hospital porter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",37.0,0.0521316,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Escriche-Escuder', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; Department of Physiotherapy, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; National Research Centre for the Working Environment, Copenhagen, Denmark. Electronic address: joaquin.calatayud@uv.es.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Sport Sciences, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Aiguadé', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Lleida, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102162'] 227,32042166,An electroencephalographic signature predicts antidepressant response in major depression.,"Antidepressants are widely prescribed, but their efficacy relative to placebo is modest, in part because the clinical diagnosis of major depression encompasses biologically heterogeneous conditions. Here, we sought to identify a neurobiological signature of response to antidepressant treatment as compared to placebo. We designed a latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG) and applied it to data from the largest imaging-coupled, placebo-controlled antidepressant study (n = 309). Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment. This sertraline-predictive EEG signature generalized to two depression samples, wherein it reflected general antidepressant medication responsivity and related differentially to a repetitive transcranial magnetic stimulation treatment outcome. Furthermore, we found that the sertraline resting-state EEG signature indexed prefrontal neural responsivity, as measured by concurrent transcranial magnetic stimulation and EEG. Our findings advance the neurobiological understanding of antidepressant treatment through an EEG-tailored computational model and provide a clinical avenue for personalized treatment of depression.",2020,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,['major depression'],"['placebo', 'latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG']","['sertraline resting-state EEG signature indexed prefrontal neural responsivity', 'Symptom improvement']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002045'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.035978,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'School of Automation Science and Engineering, South China University of Technology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Molly V', 'Initials': 'MV', 'LastName': 'Lucas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Camarin E', 'Initials': 'CE', 'LastName': 'Rolle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Carena A', 'Initials': 'CA', 'LastName': 'Cornelssen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Russell T', 'Initials': 'RT', 'LastName': 'Toll', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Hersh M', 'Initials': 'HM', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Monuszko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Trevor L', 'Initials': 'TL', 'LastName': 'Caudle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kamron', 'Initials': 'K', 'LastName': 'Sarhadi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}]",Nature biotechnology,['10.1038/s41587-019-0397-3'] 228,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN Secondary analysis of a clinical trial. OBJECTIVES To perform a secondary analysis on the effects of neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT) compared with TRT on the untrained muscles after spinal cord injury (SCI). SETTING Medical research center. METHODS Twenty-two men with chronic motor complete SCI were randomized into TRT + RT group (n = 11) or TRT group (n = 11). Both groups received 16 weeks of TRT (2-6 mg/day) via testosterone patches. The TRT + RT group received twice weekly progressive RT of the knee extensor muscles using electrical stimulation and ankle weights. Magnetic resonance images were captured to measure cross-sectional areas (CSAs) of trunk, glutei, and leg muscles. RESULTS Total and absolute gluteus maximus m. (14%, P = 0.003 and 16%, P = 0.001), gluteus medius m. (10%; P = 0.008 and 14%; P = 0.02), and total glutei m. (8%, P = 0.01 and 11%, P = 0.005) CSAs increased overtime for the TRT + RT group. Mean between-group differences of 2.86 (95% CI: 0.30, 5.4), 1.89 (95% CI: 0.23, 3.58) and 5.27 (95% CI: 0.90, 9.69) cm 2 were noted for absolute gluteus maximus, total gluteus medius and total glutei CSAs, respectively (P < 0.05). Trunk muscle CSAs showed a trend towards an interaction between groups. CONCLUSIONS RT combined with low-dose TRT results in significant hypertrophy compared with TRT only on the adjacent untrained glutei muscles. Trunk muscles may require direct stimulation to evoke hypertrophy. These exploratory findings may be of clinical relevance in the reduction of incidence and severity of pelvic pressure injuries.",2020,"RESULTS Total and absolute gluteus maximus m. (14%, P = ","['untrained muscles after spinal cord injury (SCI', 'untrained muscles after spinal cord injury', 'Twenty-two men with chronic motor complete SCI']","['testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI', 'testosterone patches', 'TRT\u2009+\u2009RT', 'TRT', 'neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT', 'CSAs']","['total glutei m', 'absolute gluteus maximus, total gluteus medius and total glutei CSAs']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",22.0,0.145549,"RESULTS Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3'] 229,30902613,Updated Efficacy and Safety Data and Impact of the EML4-ALK Fusion Variant on the Efficacy of Alectinib in Untreated ALK-Positive Advanced Non-Small Cell Lung Cancer in the Global Phase III ALEX Study.,"INTRODUCTION At the prior data cutoff (February 9, 2017) the ALEX trial showed superior investigator-assessed progression-free survival (PFS) for alectinib versus crizotinib in untreated, anaplastic lymphoma kinase (ALK)-positive, advanced NSCLC (hazard ratio = 0.47, 95% confidence interval: 0.34-0.65, p < 0.001). The median PFS in the alectinib arm was not reached versus 11.1 months with crizotinib. Retrospective analyses suggest that the echinoderm microtubule-associated protein-like 4 gene-ALK variant (EML4-ALK) may influence ALK-inhibitor treatment benefit. We present updated analyses, including exploratory subgroup analysis by EML4-ALK variant, after an additional 10 months' follow-up (cutoff December 1, 2017). METHODS Patients were randomized to receive twice-daily alectinib, 600 mg, or crizotinib, 250 mg, until disease progression, toxicity, death, or withdrawal. PFS was determined by the investigators. Baseline plasma and tissue biomarker samples were analyzed by using hybrid-capture, next-generation sequencing to determine EML4-ALK variant. RESULTS Baseline characteristics were balanced. Investigator-assessed PFS was prolonged with alectinib (stratified hazard ratio = 0.43, 95% confidence interval: 0.32-0.58). The median PFS times were 34.8 months with alectinib and 10.9 months with crizotinib. EML4-ALK fusions were detectable in 129 patient plasma samples and 124 tissue samples; variants 1, 2, and 3/ab did not affect PFS, objective response rate, or duration of response. Investigator-assessed PFS was longer for alectinib than for crizotinib across EML4-ALK variants 1, 2, and 3a/b in plasma and tissue. Despite longer treatment duration (27.0 months in the case of alectinib versus 10.8 months in the case of crizotinib), the safety of alectinib compared favorably with that of crizotinib. CONCLUSION Alectinib continues to demonstrate superior investigator-assessed PFS versus crizotinib in untreated ALK-positive NSCLC, irrespective of EML4-ALK variant.",2019,"Investigator-assessed PFS was longer for alectinib than for crizotinib across EML4-ALK variants 1, 2, and 3a/b in plasma and tissue.",['Patients'],"['twice-daily alectinib, 600 mg, or crizotinib', 'EML4-ALK Fusion Variant']","['median PFS times', 'Baseline plasma and tissue\xa0biomarker samples', 'PFS', 'superior investigator-assessed progression-free survival (PFS', 'PFS, objective response rate, or duration of response', 'median\xa0PFS', 'EML4-ALK fusions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]",,0.198512,"Investigator-assessed PFS was longer for alectinib than for crizotinib across EML4-ALK variants 1, 2, and 3a/b in plasma and tissue.","[{'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'Division of Medical Oncology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Dziadziuszko', 'Affiliation': 'Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of South China, Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Noe', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Nowicka', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Parneet', 'Initials': 'P', 'LastName': 'Cheema', 'Affiliation': 'University of Toronto, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Royal North Shore Hospital, Sydney University, Sydney, Australia.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'European Institute of Oncology, Scientific Institute for Research and Healthcare, Milan, Italy.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Severence Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Sun Yet-sen University Cancer Center, Guangdong, People's Republic of China.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Grenoble University Hospital Center, La Tronche, France.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bordogna', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bogdana', 'Initials': 'B', 'LastName': 'Balas', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Alice T', 'Initials': 'AT', 'LastName': 'Shaw', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts. Electronic address: Ashaw1@partners.org.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.03.007'] 230,32320002,How oro-sensory exposure and eating rate affect satiation and associated endocrine responses-a randomized trial.,"BACKGROUND Longer oral processing decreases food intake. This can be attributed to greater oro-sensory exposure (OSE) and a lower eating rate (ER). How these factors contribute to food intake, and the underlying physiological mechanisms, remain unclear. OBJECTIVES We aimed to determine the independent and simultaneous effects of OSE and ER on satiation and associated endocrine responses. METHODS Forty participants in study 1 [mean ± SD age: 24 ± 4 y; BMI (in kg/m2): 22 ± 2] and 20 in study 2 (mean ± SD age: 23 ± 3 y; BMI: 23 ± 2) participated in a 2 × 2 randomized trial. In both studies, participants ate chocolate custard with added caramel sauce (low OSE) or caramel fudge (high OSE) and with short (fast ER) or long breaks (slow ER) in between bites, until fullness. In study 2, endocrine responses were measured during the meal. RESULTS In study 1, participants ate (mean ± SEM) 42 ± 15 g less in the slow- than in the fast-ER condition, only within the high-OSE condition (P = 0.04). In study 2, participants ate 66 ± 21 g less in the high- than in the low-OSE condition and there were no intake differences between slow and fast ER (P = 0.35). Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control. At the end of the meal, insulin concentrations were 81% higher in the high-OSE, slow-ER than in the low-OSE, fast-ER condition (P = 0.049). Pancreatic polypeptide (PP) increased by 62%, 5 min after meal onset in the low-OSE, fast-ER condition (P = 0.005). Ghrelin concentrations did not change. CONCLUSIONS Greater OSE increases insulin responsiveness. In contrast, PP responses are stronger when OSE is reduced and ER is fast. Insulin and PP responses may mediate the independent effects of OSE and ER on food intake. These may be beneficial eating strategies, particularly for type 2 diabetic patients, to control food intake and maintain glucose homeostasis.This trial was registered at trialregister.nl as NL6544.",2020,"Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control.","['participants ate (mean\xa0±\xa0SEM) 42\xa0±\xa015 g less in the slow- than in the fast-ER condition, only within the high-OSE condition (P\xa0=\xa00.04', 'SD age: 24\xa0±\xa04\xa0y', 'Forty participants in study 1 [mean\xa0±', ' BMI: 23\xa0±\xa02) participated in a 2\xa0×\xa02 randomized trial']","['chocolate custard with added caramel sauce (low OSE) or caramel fudge (high OSE) and with short (fast ER) or long breaks (slow ER', 'OSE', 'OSE and ER']","['Ghrelin concentrations', 'insulin concentrations', 'BMI', 'eating rate (ER', 'Insulin and PP responses', 'OSE increases insulin responsiveness', 'Pancreatic polypeptide (PP']","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0453512', 'cui_str': 'Custard'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0108509', 'cui_str': 'Caramel'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0458193', 'cui_str': 'Fudge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]","[{'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic peptide'}]",,0.0776592,"Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control.","[{'ForeName': 'Marlou', 'Initials': 'M', 'LastName': 'Lasschuijt', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Mars', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'de Graaf', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Paul A M', 'Initials': 'PAM', 'LastName': 'Smeets', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa067'] 231,32320024,Effect of chicory inulin-type fructan-containing snack bars on the human gut microbiota in low dietary fiber consumers in a randomized crossover trial.,"BACKGROUND The low intake of dietary fiber compared to recommended amounts has been referred to as the dietary fiber gap. The addition of fiber to snack foods could favorably alter gut microbiota and help individuals meet intake recommendations. OBJECTIVES Our objective was to examine the effect of low- and moderate-dose fiber-containing snack bars, comprising mainly chicory root inulin-type fructans (ITF), on gut microbiota in healthy adults with habitual low dietary fiber intake using 16S ribosomal RNA-based approaches. METHODS In 2 separate 4-wk, placebo-controlled, double-blind, crossover trials, 50 healthy adults with low dietary fiber intake were randomly assigned to receive isocaloric snack bars of either moderate-dose fiber (7 g/d) or control in Trial 1 (n = 25) or low-dose fiber (3 g/d) or control in Trial 2 (n = 25), with 4-wk washout periods. Fecal microbiota composition and inferred function, fecal SCFA concentration, gastrointestinal (GI) symptoms, dietary intake, and quality of life were measured. RESULTS Compared with the control group, the moderate-dose group showed significant differences across multiple microbial taxa, most notably an increased relative abundance of the Bifidobacterium genus from (mean ± SEM) 5.3% ± 5.9% to 18.7% ± 15.0%. With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium. Predictive functional profiling identified changes in predicted function after intake of the moderate- but not the low-dose bar. Fecal SCFAs were affected by time but not treatment. There were no between-group differences in GI symptoms. Importantly, fiber intake increased significantly with the moderate- and low-dose bars. CONCLUSIONS In healthy adults, adding 3 or 7 g ITF to snack bars increased Bifidobacterium, a beneficial member of the gut microbial community. The addition of ITF to food products could help reduce the dietary fiber gap prevalent in modern life.This trial was registered at clinicaltrials.gov as NCT03042494.",2020,"With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium.","['healthy adults', '50 healthy adults with low dietary fiber intake', 'healthy adults with habitual low dietary fiber intake using 16S ribosomal RNA-based approaches']","['isocaloric snack bars of either moderate-dose fiber (7 g/d) or control in Trial 1 (n\xa0=\xa025) or low-dose fiber', 'chicory inulin-type fructan-containing snack bars', 'low- and moderate-dose fiber-containing snack bars, comprising mainly chicory root inulin-type fructans (ITF', 'placebo']","['relative abundance', 'Fecal SCFAs', 'fiber intake', 'GI symptoms', 'Fecal microbiota composition and inferred function, fecal SCFA concentration, gastrointestinal (GI) symptoms, dietary intake, and quality of life', 'Bifidobacterium']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0242868', 'cui_str': 'Chicory'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3537684', 'cui_str': 'chicory root extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",50.0,0.151477,"With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium.","[{'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Soto-Vaca', 'Affiliation': 'General Mills Bell Institute of Health and Nutrition, Golden Valley, MN, USA.'}, {'ForeName': 'Alissa C', 'Initials': 'AC', 'LastName': 'Nicolucci', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Shyamchand', 'Initials': 'S', 'LastName': 'Mayengbam', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Heekuk', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Division of Gastroenterology, Centre of Excellence for Gastrointestinal Inflammation and Immunity Research, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Menon', 'Affiliation': 'General Mills Bell Institute of Health and Nutrition, Golden Valley, MN, USA.'}, {'ForeName': 'Elaine E', 'Initials': 'EE', 'LastName': 'Vaughan', 'Affiliation': 'Sensus BV (Royal Cosun), Roosendaal, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa074'] 232,32316899,Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial.,"INTRODUCTION Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects millions of people around the world and represents a major medical and socioeconomic problem. The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients affected by symptomatic HD in comparison with the results obtained from a control group. MATERIALS AND METHODS From January to February 2019, all the patients referred to the outpatient clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms, were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients were only under a controlled diet without any treatment - control group. RESULTS A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet. No major adverse events associated with the use of the new product were recorded. CONCLUSION The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated to be promising with a good profile of tolerability, safety and efficacy.",2020,All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet.,"['patients affected by symptomatic HD in comparison with the results obtained from a control group', 'Haemorrhoidal Disease in Adults', '51 subjects were screened and 45 (13 F- 32 M) enrolled into the study', 'From January to February 2019 all the patients referred to the outpatient clinic of at Rajalakshmi Hospital who were complaining of first or second degree hemorrhoidal symptoms were enrolled in the study']","['Proctosoll Allevia®', 'controlled diet without any treatment - control group', 'Proctosoll Allevia']","['tolerability, safety and efficacy', 'safety and efficacy', 'symptoms']","[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0443298', 'cui_str': 'Second degree'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",51.0,0.0199957,All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet.,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sturiale', 'Affiliation': 'Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Brusciano', 'Affiliation': 'Department of Medical, Surgical, Neurologic, Metabolic and Aging Sciences, General, Mininvasive and Obesity Surgery Unit, University of Campania ""Luigi Vanvitelli"" Naples, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Cacace', 'Affiliation': 'Proctology and Pelvic Floor Clinical Centre, General Surgery, Pisa, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Cafaro', 'Affiliation': 'Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Italy.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Celedon Porzio', 'Affiliation': 'Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Naldini', 'Affiliation': 'Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Italy.'}]",Reviews on recent clinical trials,['10.2174/1574887115666200421110107'] 233,31984760,A Novel Flexible Ureteroscope with Omnidirectional Bending Tip Using Joystick-Type Control Unit (URF-Y0016): Initial Validation Study in Bench Models.,"Purpose: The conventional flexible ureteroscope has limited access into the lower calix and often causes biomechanical stress to surgeons. Recently, a novel flexible ureteroscope with an omnidirectional bending tip with a joystick-type control unit (URF-Y0016; Olympus, Japan) was developed. We verified the operability and ergonomics of the URF-Y0016 compared with that of the conventional flexible ureteroscope (URF-P6) in bench models. Materials and Methods: Twenty-five medical students with no experience in performing ureteroscopic manipulation were randomly assigned to URF-Y0016 and URF-P6 leading groups in a crossover study. The task was performed using a simple model as an exploratory experiment and an artificial kidney model as an evaluation experiment. We compared the task completion times of both groups, while the factors influencing task completion time were entered into a multivariate model. The ergonomics of endourology were compared using a validated questionnaire. Results: The task completion time in the URF-Y0016 group was significantly shorter than in the URF-P6 group ( p  < 0.001). The URF-Y0016 group showed no difference in task completion time between each renal calix, whereas in the URF-P6 group the task completion time in the lower calix was significantly longer than that in other calices ( p  < 0.001). In multivariate analysis, the model of flexible ureteroscope used significantly influenced the task completion time ( p  < 0.001). The ergonomics of the URF-Y0016 group were significantly better than those of the URF-P6 group ( p  = 0.001). Conclusions: URF-Y0016 may offer benefits in ureteroscopy performance over the conventional flexible ureteroscope.",2020,"In multivariate analysis, the model of flexible ureteroscope used significantly influenced the task completion time (p <0.001).",['Twenty-five medical students with no experience in performing ureteroscopic manipulation'],"['URF-Y0016 and URF-P6 leading groups', 'conventional flexible ureteroscope (URF-P6']",['task completion time'],"[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0392306', 'cui_str': 'Flexible ureteroscope (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",25.0,0.018808,"In multivariate analysis, the model of flexible ureteroscope used significantly influenced the task completion time (p <0.001).","[{'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Tambo', 'Affiliation': 'Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology, Hara Genitourinary Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Miura', 'Affiliation': 'Hachinohe Koyo Clinic, Aomori, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Urology, Ohguchi East General Hospital, Yokohama, Japan.'}, {'ForeName': 'Kikuo', 'Initials': 'K', 'LastName': 'Nutahara', 'Affiliation': 'Bremen Street Urology & Nephrology Clinic, Kawasaki, Japan.'}, {'ForeName': 'Shuzo', 'Initials': 'S', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Nephro-Urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Department of Urology, Gyotoku General Hospital, Chiba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Urology, Kobe University School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University, Osaka, Japan.'}]",Journal of endourology,['10.1089/end.2019.0895'] 234,32310966,"Implementer and recipient perspectives of community-wide mass drug administration for soil-transmitted helminths in Kwale County, Kenya.","Soil-transmitted helminthiases (STH) are one of 17 neglected tropical diseases (NTDs) earmarked for control or elimination by 2020 in the WHO's Roadmap on NTDs. Deworming programs for STH have thus far been focused on treating pre-school and school-aged children; however, there is a growing consensus that to achieve elimination of STH transmission, programs must also target adults, potentially through community-wide mass drug administration (MDA). There is currently a gap in the literature on what components are required to deliver community-wide MDA for STH in order to achieve high intervention reach and uptake. Nested within the TUMIKIA Project, a cluster randomized trial in Kenya evaluating the effectiveness of school-based deworming versus community-wide MDA, we collected qualitative data from program implementers and recipients in eight clusters where community-wide MDA was delivered. Data collection included semi-structured in-depth interviews (n = 72) and focus group discussions (n = 32). A conceptual framework for drug distribution was constructed to help build an analysis codebook. Case memos were developed for each top-level theme. Community-wide MDA for STH was perceived as a complex intervention with key administrative and social mobilization domains. Key actionable themes included: (1) developing an efficient strategy to allocate reasonable workload for implementers to cover all targeted households; (2) maximizing community drug distributors' motivation through promoting belief in the effectiveness of the intervention and providing sufficient financial incentives; (3) developing effective capacity building strategies for implementers; and (4) implementing a context-adapted community engagement strategy that leverages existing community structures and takes into consideration past community experiences of MDAs. Transitioning from STH control to elimination goals requires significant planning and action to ensure community-wide MDA is delivered with sufficient reach and uptake. We present findings that can inform national deworming programs to increase intervention delivery capacity.",2020,"Nested within the TUMIKIA Project, a cluster randomized trial in Kenya evaluating the effectiveness of school-based deworming versus community-wide MDA, we collected qualitative data from program implementers and recipients in eight clusters where community-wide MDA was delivered.","['soil-transmitted helminths in Kwale County, Kenya']","['intervention and providing sufficient financial incentives; (3) developing effective capacity building strategies for implementers; and (4) implementing a context-adapted community engagement strategy that leverages existing community structures', 'Soil-transmitted helminthiases (STH', 'school-based deworming versus community-wide MDA']",[],"[{'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0445519', 'cui_str': 'Kwale'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]",[],,0.0260652,"Nested within the TUMIKIA Project, a cluster randomized trial in Kenya evaluating the effectiveness of school-based deworming versus community-wide MDA, we collected qualitative data from program implementers and recipients in eight clusters where community-wide MDA was delivered.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Legge', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Kepha', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Mateo', 'Initials': 'M', 'LastName': 'Prochazka', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Halliday', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pullan', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Gwayi-Chore', 'Affiliation': 'Department of Global Health, University of Washington, School of Public Health, Seattle, Washington, United States of America.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Njomo', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008258'] 235,32312337,Do infants of breast-feeding mothers benefit from additional long-chain PUFA from fish oil? A 6-year follow-up.,"Fish-oil supplements are marketed as enhancing intelligence and cognitive performance. However, empirical data concerning the utility of these products in healthy term infants are mixed, particularly with respect to lasting effects into childhood. We evaluated whether fish-oil supplementation during infancy leads to better neurocognitive/behavioural development at 6 years. We conducted a double-blind randomised controlled trial of supplementation with n-3 long-chain PUFA in 420 healthy term infants. Infants received either fish oil (containing at least 250 mg DHA and at least 60 mg EPA) or placebo (olive oil) daily from birth to 6 months of age. Neurodevelopmental follow-up was conducted at a mean age of 6 years (sd 7 months), whereby 335 children were assessed for language, executive functioning, global intelligence quotient and behaviour. No significant differences were observed between the groups for the main neurocognitive outcomes. However in parent-report questionnaire, fish-oil supplementation was associated with negative externalising (P = 0·035, d = 0·24) and oppositional/defiant behaviour (P = 0·006, d = 0·31), particularly in boys (P = 0·01, d = 0·45; P = 0·004, d = 0·40). Our results provide evidence that fish-oil supplementation to predominantly breast-fed infants confers no significant cognitive or behavioural benefit to children at 6 years.",2020,"However in parent-report questionnaire, fish-oil supplementation was associated with negative externalizing (P = 0.035, d = .24) and oppositional/defiant behaviour (P = 0.006, d = .31), particularly in boys (P = 0.01, d = .45 ; P = 0.004, d = .40).","['healthy term infants', '420 healthy term infants']","['supplementation with omega-3 long-chain polyunsaturated fatty acid (n-3 LCPUFA', 'fish oil supplementation', 'Fish-oil supplements', 'fish oil [containing at least 250 mg docosahexaenoic acid (DHA) and at least 60 mg eicosapentaenoic acid (EPA)] or placebo (olive oil', 'fish-oil supplementation']","['negative externalizing', 'oppositional/defiant behaviour', 'language, executive functioning, global IQ and behaviour']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0424348', 'cui_str': 'Defiant behavior'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",420.0,0.426369,"However in parent-report questionnaire, fish-oil supplementation was associated with negative externalizing (P = 0.035, d = .24) and oppositional/defiant behaviour (P = 0.006, d = .31), particularly in boys (P = 0.01, d = .45 ; P = 0.004, d = .40).","[{'ForeName': 'Suzanne J', 'Initials': 'SJ', 'LastName': 'Meldrum', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Heaton', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Foster', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Simmer', 'Affiliation': 'School of Paediatrics and Child Health, Faculty of Health and Medical Science, The University of Western Australia, Crawley, WA6009, Australia.'}]",The British journal of nutrition,['10.1017/S000711452000135X'] 236,32311700,Effects of vitamin D supplementation on circulating concentrations of growth factors and immune-mediators in healthy women during pregnancy.,"BACKGROUND For the second aim of the Kellogg Foundation grant, this double-blind RCT investigated the impact of plasma vitamin D metabolite 25-hydroxyvitamin D (25(OH)D) on plasma immune-mediators during pregnancy. We hypothesized that higher 25(OH)D concentrations would associate with reduced pro-inflammatory and increased tolerogenic immune-mediator concentrations. METHODS Pregnant women enrolled at 10-14 weeks gestation were randomized to 400 or 4400 IU vitamin D 3 /day. Data on health, safety, circulating 25(OH)D, and 9 immune-mediators were collected at each trimester. Associations between immune-mediators and 25(OH)D at baseline and at second and third trimesters were examined. RESULTS Baseline TGF-β and second and third trimesters IFN-γ and IL-2 were associated with baseline 25(OH)D. Baseline immune-mediators were associated with immune-mediators at second and third trimesters for all immune-mediators except IL-5 and IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters. CONCLUSIONS Both treatment groups had increased 25(OH)D at second and third trimesters, greatest in the 4400 IU group. Though associations between baseline 25(OH)D and baseline TGF-β and second and third trimester IFN-γ and IL-2 were noted, vitamin D supplementation throughout pregnancy did not impact immune-mediators at later trimesters. Supplementing with vitamin D before conception conceivably influences immune-mediator responses during pregnancy. IMPACT In this vitamin D supplementation clinical trial, baseline (first trimester) but not increasing plasma 25(OH)D concentration impacted select plasma immune-mediator profiles in pregnant women. Baseline 25(OH)D was associated with baseline TGF-β and with IFN-γ and IL-2 at second and third trimesters. Baseline IFN-γ, CRP, TGF-β, TNF-α, VEGF, IL-2, and IL-4 were associated with concentrations at second and third trimesters for respective immune-mediators; however, 25(OH)D concentration at second and third trimesters were not. Some racial differences existed in immune-mediator concentrations at baseline and at second and third trimesters. This study assesses the impact of vitamin D supplementation on multiple immune-mediators in pregnant women of different racial/ethnic groups using longitudinal data from a relatively large randomized controlled trial. This study found that race was associated with baseline TGF-β, VEGF, and IL-10 and with IL-10 at second and third trimesters, a novel finding that sheds light where relationships were less well defined. The results of this study suggest that vitamin D supplementation before conception or early in pregnancy, rather than during pregnancy, may be necessary to significantly impact immune-mediator response. This study sets premise for future clinical trials to evaluate the effect of vitamin D supplementation before conception or prior to pregnancy.",2020,"IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters. ","['pregnant women', 'Pregnant women enrolled at 10-14 weeks gestation', 'pregnant women of different racial/ethnic groups', 'healthy women during pregnancy']","['vitamin D 3 /day', 'vitamin D supplementation', 'plasma vitamin D metabolite 25-hydroxyvitamin D (25(OH)D', 'vitamin D']","['Baseline IFN-γ, CRP, TGF-β, TNF-α, VEGF, IL-2, and IL-4', 'baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters', 'immune-mediator concentrations', 'health, safety, circulating 25(OH)D, and 9 immune-mediators', 'multiple immune-mediators', '25(OH)D concentration', 'immune-mediator responses', 'baseline TGF-β, VEGF, and IL-10 and with IL-10', 'circulating concentrations of growth factors and immune-mediators']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}]",,0.420897,"IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters. ","[{'ForeName': 'Aastha', 'Initials': 'A', 'LastName': 'Khatiwada', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Mulligan', 'Affiliation': 'Department of Otolaryngology - Head & Neck Surgery, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Shary', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hewison', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Medical School, IBR Tower, Level 2, Birmingham, B15 2TT, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Baatz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Danforth A', 'Initials': 'DA', 'LastName': 'Newton', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hawrylowicz', 'Affiliation': ""Division of Asthma, Allergy and Lung Biology, King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA. wagnercl@musc.edu.'}]",Pediatric research,['10.1038/s41390-020-0885-7'] 237,32238507,Telephone-based cognitive behavioral therapy for depression in Parkinson disease: A randomized controlled trial.,"OBJECTIVE To determine whether, for patients with depression and Parkinson disease (PD), telephone-based cognitive-behavioral treatment (T-CBT) alleviates depressive symptoms significantly more than treatment as usual (TAU), we conducted a randomized controlled trial to evaluate the efficacy of a 10-session T-CBT intervention for depression in PD, compared to TAU. METHODS Seventy-two people with PD (PWP) were randomized to T-CBT + TAU or TAU only. T-CBT tailored to PWPs' unique needs was provided weekly for 3 months, then monthly during 6-month follow-up. CBT targeted negative thoughts (e.g., ""I have no control""; ""I am helpless"") and behaviors (e.g., social withdrawal, excessive worry). It also trained care partners to help PWP practice healthy habits. Blind raters assessed outcomes at baseline, midtreatment, treatment end, and 1 and 6 months post-treatment. Analyses were intent to treat. RESULTS T-CBT outperformed TAU on all depression, anxiety, and quality of life measures. The primary outcome (Hamilton Depression Rating Scale score) improved significantly in T-CBT compared to TAU by treatment end. Mean improvement from baseline was 6.53 points for T-CBT and -0.27 points for TAU ( p < 0.0001); gains persisted over 6-month follow-up ( p < 0.0001). Improvements were moderated by a reduction in negative thoughts in the T-CBT group only, reflecting treatment target engagement. CONCLUSIONS T-CBT may be an effective depression intervention that addresses a significant unmet PD treatment need and bypasses access barriers to multidisciplinary, evidence-based care. CLINICALTRIALSGOV IDENTIFIER NCT02505737. CLASSIFICATION OF EVIDENCE This study provides Class I evidence that for patients with depression and PD, T-CBT significantly alleviated depressive symptoms compared to usual care.",2020,Mean improvement from baseline was 6.53 points for T-CBT and -0.27 points for TAU ( p < 0.0001); gains persisted over 6-month follow-up ( p < 0.0001).,"['patients with depression and Parkinson disease (PD), telephone-based cognitive-behavioral treatment (T-CBT) alleviates depressive symptoms significantly more than treatment as usual (TAU', 'Parkinson disease', 'Seventy-two people with PD (PWP']","['10-session T-CBT intervention', 'T-CBT + TAU or TAU', 'Telephone-based cognitive behavioral therapy']","['depressive symptoms', 'negative thoughts', 'depression, anxiety, and quality of life measures', 'primary outcome (Hamilton Depression Rating Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",72.0,0.0946385,Mean improvement from baseline was 6.53 points for T-CBT and -0.27 points for TAU ( p < 0.0001); gains persisted over 6-month follow-up ( p < 0.0001).,"[{'ForeName': 'Roseanne D', 'Initials': 'RD', 'LastName': 'Dobkin', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons. dobkinro@rutgers.edu.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mann', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gara', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Interian', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Kailyn M', 'Initials': 'KM', 'LastName': 'Rodriguez', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Menza', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}]",Neurology,['10.1212/WNL.0000000000009292'] 238,32034024,Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties.,"BACKGROUND Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS Two National Health Service health trusts and local authority children's social care. PARTICIPANTS Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER ISRCTN14573230.",2020,"No serious adverse events reported. ","['parents affected by severe personality difficulties', ""Two National Health Service health trusts and local authority children's social care"", 'child mental health', 'Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent', 'Child', '48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later']","[' 16-session home-based intervention using parenting and therapeutic engagement strategies', 'Specialist parenting intervention', 'Helping Families Programme-Modified (HFP-M', 'HFP-M', 'helping families programme-modified', 'Usual care: standard care augmented by single psychoeducational parenting session', 'intensive parenting intervention']","['coexistent parenting and child mental health difficulties', 'child behaviour (Eyberg Child Behaviour Inventory', ""Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27"", 'participant retention rate', 'i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised', 'alliance rating']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0222045'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",48.0,0.165181,"No serious adverse events reported. ","[{'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Day', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK crispin.1.day@kcl.ac.uk.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Briskman', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Mike J', 'Initials': 'MJ', 'LastName': 'Crawford', 'Affiliation': 'The Centre for Psychiatry, Imperial College, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Foote', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Harris', 'Affiliation': 'Centre for Parent and Child Support, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Boadu', 'Affiliation': ""King's Health Economics, P024 David Goldberg Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, P024 David Goldberg Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McMurran', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Moran', 'Affiliation': 'Department of Population Health Sciences, Centre for Academic Mental Health, University of Bristol, Bristol, UK.'}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Mosse', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ramchandani', 'Affiliation': 'Faculty of Education, PEDAL Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Department of Mental Health, Middlesex University, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033637'] 239,30652422,Effects of ursodeoxycholic acid on the gut microbiome and colorectal adenoma development.,"It has been previously reported that ursodeoxycholic acid (UDCA), a therapeutic bile acid, reduced risk for advanced colorectal adenoma in men but not women. Interactions between the gut microbiome and fecal bile acid composition as a factor in colorectal cancer neoplasia have been postulated but evidence is limited to small cohorts and animal studies. Using banked stool samples collected as part of a phase III randomized clinical trial of UDCA for the prevention of colorectal adenomatous polyps, we compared change in the microbiome composition after a 3-year intervention in a subset of participants randomized to oral UDCA at 8-10 mg/kg of body weight per day (n = 198) or placebo (n = 203). Study participants randomized to UDCA experienced compositional changes in their microbiome that were statistically more similar to other individuals in the UDCA arm than to those in the placebo arm. This reflected a UDCA-associated shift in microbial community composition (P < 0.001), independent of sex, with no evidence of a UDCA effect on microbial richness (P > 0.05). These UDCA-associated shifts in microbial community distance metrics from baseline to end-of-study were not associated with risk of any or advanced adenoma (all P > 0.05) in men or women. Separate analyses of microbial networks revealed an overrepresentation of Faecalibacterium prausnitzii in the post-UDCA arm and an inverse relationship between F prausnitzii and Ruminococcus gnavus. In men who received UDCA, the overrepresentation of F prausnitzii and underrepresentation of R gnavus were more prominent in those with no adenoma recurrence at follow-up compared to men with recurrence. This relationship was not observed in women. Daily UDCA use modestly influences the relative abundance of microbial species in stool and affects the microbial network composition with suggestive evidence for sex-specific effects of UDCA on stool microbial community composition as a modifier of colorectal adenoma risk.",2019,Separate analyses of microbial networks revealed an overrepresentation of Faecalibacterium prausnitzii in the post-UDCA arm and an inverse relationship between F prausnitzii and Ruminococcus gnavus.,['advanced colorectal adenoma in men but not women'],"['placebo', 'oral UDCA', 'ursodeoxycholic acid (UDCA', 'UDCA', 'ursodeoxycholic acid']","['microbial community distance metrics', 'gut microbiome and colorectal adenoma development', 'microbial richness', 'risk of any or advanced adenoma']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]",203.0,0.192193,Separate analyses of microbial networks revealed an overrepresentation of Faecalibacterium prausnitzii in the post-UDCA arm and an inverse relationship between F prausnitzii and Ruminococcus gnavus.,"[{'ForeName': 'Talima', 'Initials': 'T', 'LastName': 'Pearson', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Caporaso', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Yellowhair', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Bokulich', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Padi', 'Affiliation': 'Department of Molecular and Cellular Biology, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Denise J', 'Initials': 'DJ', 'LastName': 'Roe', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Betsy C', 'Initials': 'BC', 'LastName': 'Wertheim', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linhart', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Cherae', 'Initials': 'C', 'LastName': 'Bilagody', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Heidie', 'Initials': 'H', 'LastName': 'Hornstra', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lance', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Thompson', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}]",Cancer medicine,['10.1002/cam4.1965'] 240,30618054,"Safety, tolerability, pharmacokinetics and effect on serum uric acid of the myeloperoxidase inhibitor AZD4831 in a randomized, placebo-controlled, phase I study in healthy volunteers.","AIMS Myeloperoxidase activity can contribute to impaired vascular endothelial function and fibrosis in chronic inflammation-related cardiovascular disease. Here, we investigated the safety, tolerability and pharmacokinetics of the myeloperoxidase inhibitor, AZD4831. METHODS In this randomized, single-blind, placebo-controlled, phase I, first-in-human study, healthy men in five sequential cohorts were randomized 3:1 to receive a single oral dose of AZD4831 (5, 15, 45, 135 or 405 mg) or placebo, after overnight fasting. After at least 7 days' washout, one cohort additionally received AZD4831 45 mg after a high-calorie meal. RESULTS Forty men participated in the study (eight per cohort: AZD4831, n = 6; placebo, n = 2). AZD4831 distributed rapidly into plasma, with a half-life of 38.2-50.0 hours. The area under the plasma concentration-time curve (AUC) increased proportionally with dose (AUC 0-∝ slope estimate 1.060; 95% confidence interval [CI] 0.9943, 1.127). Increases in maximum plasma concentration were slightly more than dose proportional (slope estimate 1.201; 95% CI 1.071, 1.332). Food intake reduced AZD4831 absorption rate but did not substantially affect overall exposure or plasma half-life (n = 4). Serum uric acid concentrations decreased by 71.77 (95% CI 29.15, 114.39) and 84.42 (58.90, 109.94) μmol L -1 with AZD4831 135 mg and 405 mg, respectively. Maculopapular rash (moderate intensity) occurred in 4/30 participants receiving AZD4831 (13.3%). No other safety concerns were identified. CONCLUSIONS AZD4831 was generally well tolerated, rapidly absorbed, had a long plasma half-life and lowered uric acid concentrations after single oral doses in healthy men. These findings support the further clinical development of AZD4831.",2019,"Serum uric acid concentrations decreased by 71.77 (95% CI 29.15, 114.39) and 84.42 (58.90, 109.94) μmol","['Forty men participated in the study (eight per cohort', 'healthy men', 'healthy volunteers', 'healthy men in five sequential cohorts']","['AZD4831 45\xa0mg after a high-calorie meal', 'placebo', 'AZD4831']","['AZD4831 absorption rate', 'Serum uric acid concentrations', 'maximum plasma concentration', 'Safety, tolerability, pharmacokinetics and effect on serum uric acid of the myeloperoxidase inhibitor', 'Maculopapular rash (moderate intensity', 'area under the plasma concentration-time curve (AUC', 'uric acid concentrations', 'safety, tolerability and pharmacokinetics']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0423791', 'cui_str': 'Maculopapular rash (morphologic abnormality)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]",40.0,0.259789,"Serum uric acid concentrations decreased by 71.77 (95% CI 29.15, 114.39) and 84.42 (58.90, 109.94) μmol","[{'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Gan', 'Affiliation': 'Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lagerström-Fermér', 'Affiliation': 'Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ericsson', 'Affiliation': 'Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nelander', 'Affiliation': 'Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Eva-Lotte', 'Initials': 'EL', 'LastName': 'Lindstedt', 'Affiliation': 'Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Michaëlsson', 'Affiliation': 'Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Heijer', 'Affiliation': 'Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Whatling', 'Affiliation': 'Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rainard', 'Initials': 'R', 'LastName': 'Fuhr', 'Affiliation': 'PAREXEL Early Phase Clinical Unit, Berlin, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.13855'] 241,32164440,Phase II mixed methods' feasibility cluster randomised controlled trial of a novel community-based enhanced care intervention to improve person-centred outcomes for people living with HIV in Ghana.,"Person-centred care (PCC) for people living with HIV (PLWH) is a global goal for WHO and the UNAIDS strategy. We aimed to develop a novel person-centred intervention for community providers, test the feasibility of participant recruitment and retention, intervention delivery and to establish acceptability. Findings from qualitative interviews with PLWH and healthcare professionals were mapped onto a PCC theory in an expert intervention development workshop. A parallel feasibility cluster randomised controlled trial (cRCT) was conducted. We randomly assigned clusters (1:1) either to intervention or to standard care. The primary outcome was trial recruitment and retention. We screened 83 PLWH, enrolled 60 with 30 allocated to each arm. Recruitment and retention rates were 87% and 97%, respectively. Potential effect size achieved at final timepoint: a measure of person-centred outcomes [0.7 (95% CI 0.17-1.23) p  < 0.001]; MOSHIV [0.7 (95% CI 0.17-1.23) p  < 0.001]; Patient Experience Questionnaire [0.8 (95% CI 0.27-1.31) p  < 0.001]; CARE Measure [1.0 (95% CI 0.45-1.55) p  < 0.001], POSITIVE OUTCOMES [0.7 (95% CI 0.17-1.23) p  < 0.001]. Post-trial interviews revealed general acceptability of the intervention. The results confirm the feasibility and justify a definitive cRCT of the enhanced care intervention to improve person-centred outcomes for PLWH.Trial registration number ISRCTN13630241.",2020,The results confirm the feasibility and justify a definitive cRCT of the enhanced care intervention to improve person-centred outcomes for PLWH.Trial registration number ISRCTN13630241.,"['We screened 83 PLWH, enrolled 60 with 30 allocated to each arm', 'people living with HIV in Ghana', 'people living with HIV (PLWH']","['novel community-based enhanced care intervention', 'Person-centred care (PCC']","['Recruitment and retention rates', 'trial recruitment and retention', 'Patient Experience Questionnaire']","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.245879,The results confirm the feasibility and justify a definitive cRCT of the enhanced care intervention to improve person-centred outcomes for PLWH.Trial registration number ISRCTN13630241.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Abboah-Offei', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bristowe', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Naa Ashiley', 'Initials': 'NA', 'LastName': 'Vanderpuye-Donton', 'Affiliation': 'West Africa AIDS Foundation, Accra, Ghana.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Ansa', 'Affiliation': 'Public Health Unit, University Health Services, University of Ghana Hospital, Accra, Ghana.'}, {'ForeName': 'Yaa Dabboah', 'Initials': 'YD', 'LastName': 'Oppong-Agyei', 'Affiliation': 'Public Health Unit, University Health Services, University of Ghana Hospital, Accra, Ghana.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Abas', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Harding', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.""}]",AIDS care,['10.1080/09540121.2020.1739217'] 242,32171768,Frequency of Mass Azithromycin Distribution for Ocular Chlamydia in a Trachoma Endemic Region of Ethiopia: A Cluster Randomized Trial.,"PURPOSE Annual mass azithromycin distribution significantly reduces the prevalence of ocular Chlamydia trachomatis, the causative organism of trachoma. However, in some areas a decade or more of treatment has not controlled infection. Here, we compared multiple treatment arms from a community-randomized trial to evaluate whether increasing frequency of azithromycin distribution decreases prevalence in the short term. METHODS Seventy-two communities in Goncha Siso Enesie woreda in the Amhara region of Northern Ethiopia were randomized to 1 of 6 azithromycin distribution strategies: (1) delayed, (2) annual, (3) biannual, (4) quarterly to children only, (5) biennial, or (6) biennial plus latrine promotion. We analyzed data from the 60 communities in the delayed, annual, biannual, quarterly, and biennial distribution arms at the 12-month study visit. Communities in the annual and biennial distribution arm were combined, as they each had a single distribution before any 12-month retreatment. We assessed the effect of increased frequency of azithromycin distribution on ocular chlamydia prevalence. RESULTS Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P < .0001) and adults (P < .0001), with lower prevalence associated with higher frequency. Among children, quarterly azithromycin distribution led to a significantly greater reduction in ocular chlamydia prevalence than the World Health Organization-recommended annual treatment prevalence (mean difference -11.4%, 95% confidence interval -19.5 to -3.3%, P = .007). CONCLUSIONS Increased frequency of azithromycin distribution leads to decreased ocular chlamydia prevalence over a short-term period. In some regions with high levels of ocular chlamydia prevalence, additional azithromycin distributions may help achieve local elimination of infection.",2020,"RESULTS Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P<0.0001) and adults (P<0.0001), with lower prevalence associated with higher frequency.","['Seventy-two communities in Goncha Seso Enesie Woreda in the Amhara Region of Northern Ethiopia', '60 communities in the delayed, annual, biannual, quarterly, and biennial distribution arms at the 12-month study visit', 'ocular chlamydia in a trachoma endemic region of Ethiopia']","['azithromycin', 'azithromycin distribution strategies: 1) delayed, 2) annual, 3) biannual, 4) quarterly to children only, 5) biennial, or 6) biennial plus latrine promotion', 'azithromycin distribution']","['ocular chlamydia prevalence', 'Ocular chlamydia prevalence']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0040592', 'cui_str': 'Egyptian Ophthalmia'}, {'cui': 'C0243130', 'cui_str': 'endemics'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023124', 'cui_str': 'Latrines'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0495108,"RESULTS Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P<0.0001) and adults (P<0.0001), with lower prevalence associated with higher frequency.","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA. Electronic address: tom.lietman@ucsf.edu.'}, {'ForeName': 'Berhan', 'Initials': 'B', 'LastName': 'Ayele', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Gebre', 'Affiliation': 'International Trachoma Initiative, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mulat', 'Initials': 'M', 'LastName': 'Zerihun', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Emerson', 'Affiliation': 'International Trachoma Initiative, Atlanta, Georgia, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nash', 'Affiliation': 'The Carter Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.019'] 243,32358267,Influence of angle κ on visual and refractive outcomes after implantation of a diffractive trifocal intraocular lens.,"PURPOSE To evaluate changes in angle κ after the implantation of a trifocal intraocular lens (IOL) and to assess the postoperative outcomes of patients with different angle κ values. SETTING IOA Madrid Innova Ocular, Madrid, Spain. DESIGN Prospective trial. METHODS Sixty-three eyes from 63 patients who had bilateral implantation of a diffractive trifocal IOL (POD F, PhysIOL) were included. Pupil offset was used as the best estimate of angle κ and was measured using Pentacam (Oculus) preoperatively and at 3 months postoperatively. Postoperative refractive outcomes (sphere, cylinder, and manifest refraction spherical equivalent) and visual outcomes at far, intermediate, and near distance were assessed and compared between eyes with small pupil offset and eyes with large pupil offset. Quality of vision was assessed using a subjective questionnaire. RESULTS There was a significant decrease in pupil offset values postoperatively (mean: 0.197 ± 0.12 mm) compared with those preoperatively (mean: 0.239 ± 0.12 mm), with a mean decrease of -0.042 mm (P = .0002). The same significant decrease was found for both right and left eyes, when analyzed separately. No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset. The majority of patients (14 of 16) complaining of significant halos had eyes with small pupil offset. CONCLUSIONS Large pupil offset did not negatively affect visual and refractive outcomes. The tolerance to larger pupil offset might be due to the IOL optical design, with the first diffractive ring being larger than other commonly used multifocal IOLs. More studies comparing various diffractive IOL models would be useful to confirm such hypothesis.",2020,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"['IOA Madrid Innova Ocular, Madrid, Spain', 'Sixty-three eyes from 63 patients who had bilateral implantation of a diffractive trifocal IOL (POD F, PhysIOL) were included', 'patients with different angle κ values']",['trifocal intraocular lens (IOL'],"['Postoperative refractive outcomes (sphere, cylinder, and manifest refraction spherical equivalent) and visual outcomes at far, intermediate, and near distance', 'visual and refractive outcomes', 'pupil offset values', 'Quality of vision', 'refractive and visual acuity outcomes']","[{'cui': 'C0648637', 'cui_str': 'isooctyl acrylate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",63.0,0.0391853,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garzón', 'Affiliation': 'From the IOA Madrid Innova Ocular (Garzón, López-Artero, Poyales); Department of Optica II, Complutense University, Madrid (Garzón, García-Montero); Clínica Oftalmológica Dr Gonzalo Muñoz, Valencia (Albarrán-Diego); Department of Ophthalmology (Oftalmar), Vithas Medimar International Hospital, Alicante (Pérez-Cambrodí); and Begitek, Innova Ocular (Illarramendi), Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'García-Montero', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'López-Artero', 'Affiliation': ''}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Albarrán-Diego', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez-Cambrodí', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Illarramendi', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Poyales', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000156'] 244,30911782,Use of antiosteoporotic medication in the Danish ROSE population-based screening study.,"Use of antiosteoporotic medication in the population-based, risk-stratified osteoporosis strategy evaluation (ROSE) screening study, comparing the use of FRAX followed by DXA with usual care, was examined. Screening increased the overall use of medication. Being recommended treatment by the hospital and higher age increased the likelihood of starting medication, but, nevertheless, a large percentage opted not to start treatment. INTRODUCTION The aim of the study was to examine the impact on medication prescription, adherence, and persistence of osteoporotic medicine in the randomized population-based ROSE screening study for osteoporosis. METHODS The Danish ROSE study included a population-based random sample of women aged 65-81 years randomized to either a two-step screening program consisting of FRAX followed by DXA for high-risk participants or opportunistic screening for osteoporosis (usual care). This sub-study on the intention-to-treat population examined the impact of the screening program on antiosteoporotic medication redemption rates, adherence, and persistence using Danish registers. RESULTS A total of 30,719 of 34,229 women were treatment-naïve. Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found. Higher age was associated with a higher likelihood of starting medication. A low Charlson comorbidity score (= 1) was associated with higher treatment initiation but lower adherence and persistence of antiosteoporotic treatment. A total of 31.7% of participants advised to initiate treatment did not follow the advice. CONCLUSIONS Screening for osteoporosis using FRAX followed by DXA increased the overall use of antiosteoporotic medication in the screening group without differences in adherence and persistence rates. A large percentage of participants advised to initiate treatment did nevertheless fail to do so.",2019,"Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found.","['Danish ROSE study included a population-based random sample of women aged 65-81\xa0years', 'A total of 30,719 of 34,229 women were treatment-naïve']","['antiosteoporotic medication', 'FRAX followed by DXA for high-risk participants or opportunistic screening for osteoporosis (usual care', 'FRAX']","['antiosteoporotic medication', 'adherence and persistence rates', 'overall use of medication']","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0422389', 'cui_str': 'Opportunistic screening (procedure)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",34229.0,0.0382527,"Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Høiberg', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark. mikkelhoiberg@gmail.com.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Rubin', 'Affiliation': 'OPEN - Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holmberg', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Rothmann', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'OPEN - Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gram', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bech', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brixen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Hermann', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-04934-7'] 245,32314015,Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial.,"PURPOSE This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD). METHODS We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects. RESULTS Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups. CONCLUSION Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.",2020,"Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25).","['women delivered only by elective cesarean section', '200 women aged ≥\u200918\xa0years who previously delivered by elective CD willing to receive LNG-IUS', 'family planning clinic of Cairo University hospitals from August 2019 to January 2020', 'women undergoing elective cesarean delivery (CD']","['vaginal dinoprostone or placebo', 'Dinoprostone', 'levonorgestrel-releasing intrauterine system insertion', 'vaginal dinoprostone', 'placebo', 'dinoprostone 3\xa0mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion', 'dinoprostone']","['Adverse events', 'Satisfaction score', 'tolerable side effects', 'pain during LNG-IUS insertion', 'pain during insertion and 30\xa0min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects', 'efficacy and safety', 'pain', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1131356', 'cui_str': 'Dinoprostone 3 MG'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",200.0,0.845057,"Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Abdelhakim', 'Affiliation': 'Department of Histology, Faculty of Medicine, Kasr-Alainy, Cairo University, Cairo, Egypt. ahmed.m.rohei@students.kasralainy.edu.eg.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omneya M', 'Initials': 'OM', 'LastName': 'Osman', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05543-0'] 246,32201309,Scaling Implementation of the Serious Illness Care Program Through Coaching.,"BACKGROUND We designed group coaching calls to reinforce communication skill acquisition and Serious Illness Care Program uptake in adult primary care. MEASURES Percentage of primary care physicians (PCPs) who have documented a serious illness conversation in the electronic health record (EHR) approximately three and six months after the coaching intervention. Participant feedback surveys to better understand provider attitudes toward the coaching intervention. INTERVENTION We offered 60-minute group coaching calls to internal medicine PCPs, previously trained in serious illness conversation skills, as part of an institutional quality incentive program. The calls addressed communication challenges common to serious illness care and instructed participants about how to document and bill for conversations. OUTCOMES We completed 31 coaching calls during three months, in which 170 of 228 PCPs attended in groups of two to nine participants per call (74.6% penetration rate). The percentage of PCPs who documented at least one serious illness conversation in the EHR increased from 18.4% to 41.2% six months after the intervention. Primary care internal medicine physicians found the one-hour coaching calls to be highly valuable, with 86.9% of respondents attesting they would recommend the calls to their colleagues. Content analysis of participant feedback identified the most useful coaching content elements to be self-reflection around the impact of prior conversation skills training, instruction around using the EHR to find and document advance care planning discussions, the opportunity to share individual challenges and successes with peers, and feedback/advice from communication experts in palliative care. CONCLUSIONS/LESSONS LEARNED Group coaching of PCPs resulted in more than a twofold increase in documented serious illness conversations.",2020,"Primary care internal medicine physicians found the one-hour coaching calls to be highly valuable, with 86.9% of respondents attesting they would recommend the calls to their colleagues.",[],[],"['percentage of PCPs', 'serious illness conversations', 'serious illness conversation in the electronic health record (EHR', 'EHR']",[],[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",,0.0201856,"Primary care internal medicine physicians found the one-hour coaching calls to be highly valuable, with 86.9% of respondents attesting they would recommend the calls to their colleagues.","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Alexander Cole', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: calexandercole@mgh.harvard.edu.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Wilson', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Phuong L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Hazeltine', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.03.008'] 247,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs microtubules, has androgen receptor (AR) inhibitory effects and is used in both the castration resistant and sensitive settings, where androgen dynamics may impact outcome. The present analysis evaluates the association of decline in serum androgen levels (Testosterone (T), Androstenedione (A) and DHEA in docetaxel-treated mCRPC patients with OS. METHODS Data from 1050 men treated on CALGB 90401 with docetaxel, prednisone and either bevacizumab or placebo were evaluated. Eligibility required progressive mCRPC and no prior chemotherapy. Pre-treatment, 6 week and progression serum assays for T, A and DHEA were performed via tandem Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Changes in T, A and DHEA levels from baseline to 6 weeks were calculated as the ratio of 6-week over baseline. The proportional hazards model was used to assess the prognostic significance of changes in T, A, and DHEA from baseline to 6 weeks in predicting OS adjusting for known prognostic factors. RESULTS Median baseline values for T, A, and, DHEA were 1.0, 13.5, and 8.1 ng/dL respectively while 6 week levels were 0.64, 7.0, and 6.8 ng/dL respectively. Median OS for low testosterone decline is 20.9 months vs 26.3 months for high testosterone decline. In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001). Decline in A and DHEA were not significant predictors of OS. In multivariable analysis change in the serum changes did not predict PFS however the ratio of T at 6-weeks over baseline was prognostic of ≥50% decline in PSA with an odds ratio of 0.93 (95% CI = 0.85-0.98, p-value = 0.039). CONCLUSIONS Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3'] 248,32220635,"An Invited Commentary on ""Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial"" (Int J Surg. 2020;76:37-44).",,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.137814,,"[{'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Caputo', 'Affiliation': 'Department of Surgery, University Campus Bio-Medico of Rome, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Coppola', 'Affiliation': 'Department of Surgery, University Campus Bio-Medico of Rome, Rome, Italy. Electronic address: a.coppola@unicampus.it.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.040'] 249,32300362,Affective Modulation after High-Intensity Exercise Is Associated with Prolonged Amygdalar-Insular Functional Connectivity Increase.,"Acute moderate exercise has been shown to induce prolonged changes in functional connectivity (FC) within affect and reward networks. The influence of different exercise intensities on FC has not yet been explored. Twenty-five male athletes underwent 30 min of ""low""- (35% < lactate threshold (LT)) and ""high""- (20% > LT) intensity exercise bouts on a treadmill. Resting-state fMRI was acquired at 3 Tesla before and after exercise, together with the Positive and Negative Affect Scale (PANAS). Data of 22 subjects (3 dropouts) were analyzed using the FSL feat pipeline and a seed-to-network-based analysis with the bilateral amygdala as the seed region for determining associated FC changes in the ""emotional brain."" Data were analyzed using a repeated measures ANOVA. Comparisons between pre- and post-exercise were analyzed using a one-sample t -test, and a paired t -test was used for the comparison between ""low"" and ""high"" exercise conditions (nonparametric randomization approach, results reported at p < 0.05). Both exercise interventions induced significant increases in the PANAS positive affect scale. There was a significant interaction effect of amygdalar FC to the right anterior insula, and this amygdalar-insular FC correlated significantly with the PANAS positive affect scale ( r = 0.47, p = 0.048) in the ""high""-intensity exercise condition. Our findings suggest that mood changes after exercise are associated with prolonged alterations in amygdalar-insular FC and occur in an exercise intensity-dependent manner.",2020,Both exercise interventions induced significant increases in the PANAS positive affect scale.,"['22 subjects (3 dropouts', 'Twenty-five male athletes underwent']","['30\u2009min of ""low""- (35% < lactate\u2009threshold (LT)) and ""high""- (20% > LT) intensity exercise bouts on a treadmill']","['Resting-state fMRI', 'PANAS positive affect scale']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",25.0,0.0233369,Both exercise interventions induced significant increases in the PANAS positive affect scale.,"[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Schmitt', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, Building 7, 53127 Bonn, Germany.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Upadhyay', 'Affiliation': 'German Center for Neurodegenerative Diseases, Venusberg-Campus 1, Building 99, 53127 Bonn, Germany.'}, {'ForeName': 'Jason Anthony', 'Initials': 'JA', 'LastName': 'Martin', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, Building 7, 53127 Bonn, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rojas Vega', 'Affiliation': 'Institute of Movement and Neurosciences, German Sport University, Am Sportpark Müngersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Heiko Klaus', 'Initials': 'HK', 'LastName': 'Strüder', 'Affiliation': 'Institute of Movement and Neurosciences, German Sport University, Am Sportpark Müngersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Boecker', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, Building 7, 53127 Bonn, Germany.'}]",Neural plasticity,['10.1155/2020/7905387'] 250,29282768,Effects of pain treatment on sleep in nursing home patients with dementia and depression: A multicenter placebo-controlled randomized clinical trial.,"OBJECTIVE To investigate the effects of pain treatment on sleep in nursing home (NH) patients with dementia and depression. METHODS A multicenter, 2-armed, double-blinded, placebo-controlled, randomized clinical trial conducted between August 2014 and September 2016. One hundred six long-term patients from 47 NHs in Norway with dementia and depression according to the Mini-Mental State Examination and the Cornell Scale for Depression in Dementia were included. Patients received stepwise pain treatment in which those who did not use analgesics were randomized to receive either paracetamol (3 g/day) or placebo tablets; those who already used pain treatment were allocated to buprenorphine transdermal system (max. 10 μg/h/7 days) or placebo transdermal patches. Sleep was assessed continuously for 14 days by actigraphy, 1 week of baseline measurement, and 1 week of ongoing treatment. The following sleep parameters were evaluated: total sleep time, sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset, early morning awakening (EMA), and number of wake bouts. RESULTS In the intervention group (paracetamol/buprenorphine), SE (70%-72%), SOL (32-24 min), and EMA (50-40 min) improved compared with the control group (SE, 70%-67%; SOL, 47-60 min; EMA, 31-35 min). Treatment effects were significant (P < .01, P < .05, and P < .05, respectively). CONCLUSION Compared with placebo, pain treatment improved sleep as measured with actigraphy. This implies that sleep, pain, and depression in NH patients should be critically evaluated and that pain treatment should be considered to be a potentially beneficial treatment.",2018,One hundred six long-term patients from 47 NHs in Norway with dementia and depression according to the Mini-Mental State Examination and the Cornell Scale for Depression in Dementia were included.,"['August 2014 and September 2016', 'One hundred six long-term patients from 47 NHs in Norway with dementia and depression according to the Mini-Mental State Examination and the Cornell Scale for Depression in Dementia were included', 'nursing home (NH) patients with dementia and depression', 'nursing home patients with dementia and depression', 'NH patients']","['placebo tablets', 'placebo', 'intervention group (paracetamol/buprenorphine', 'paracetamol', 'stepwise pain treatment', 'placebo transdermal patches', 'pain treatment', 'buprenorphine transdermal system (max']","['total sleep time, sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset, early morning awakening (EMA), and number of wake bouts', 'Sleep']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C4276339', 'cui_str': 'Buprenorphine Transdermal System'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0541798', 'cui_str': 'Early Awakening'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.324578,One hundred six long-term patients from 47 NHs in Norway with dementia and depression according to the Mini-Mental State Examination and the Cornell Scale for Depression in Dementia were included.,"[{'ForeName': 'Kjersti Marie', 'Initials': 'KM', 'LastName': 'Blytt', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bjorvatn', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Husebo', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Flo', 'Affiliation': 'Faculty of Psychology, Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}]",International journal of geriatric psychiatry,['10.1002/gps.4839'] 251,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND Monotherapy with immune checkpoint inhibitors has generally been unsuccessful in men with advanced prostate cancer. Preclinical data support the notion that cryotherapy may improve immune-mediated and anti-tumor responses. The objective of this study was to assess the safety and feasibility of whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation in men with oligometastatic hormone-sensitive prostate cancer. METHODS This single-institution, pilot trial recruited 12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016. Patients underwent whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab (6 doses). The primary clinical endpoints were the number of patients with a PSA level of <0.6 ng/mL at one year and the frequency of adverse events. Other outcome measures included progression-free survival and systemic therapy-free survival. Exploratory analyses included PD-L1 protein expression. RESULTS Forty two percent (5/12) of patients had a PSAs of <0.6 ng/mL at one year though only 2 of these patients had recovered their testosterone at this time point. Median progression-free survival was 14 months, and median systemic therapy-free survival was 17.5 months. PD-L1 expression was not detectable by IHC in patients with evaluable tissue. All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. CONCLUSIONS Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. ","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. ","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8'] 252,32306153,High dietary sodium augments vascular tone and attenuates low-flow mediated constriction in salt-resistant adults.,"INTRODUCTION Low-flow mediated constriction (L-FMC) has emerged as a valuable and complementary measure of flow-mediated dilation (FMD) for assessing endothelial function non-invasively. High dietary sodium has been shown to impair FMD independent of changes in blood pressure (BP), but its effects on L-FMC are unknown. PURPOSE To test the hypothesis that high dietary sodium would attenuate brachial artery L-FMC in salt-resistant adults. METHODS Fifteen healthy, normotensive adults (29 ± 6 years) participated in a controlled feeding study. Following a run-in diet, participants completed a 7-day low sodium (LS; 20 mmol sodium/day) and 7-day high sodium (HS; 300 mmol sodium/day) diet in randomized order. On the last day of each diet, 24 h urine was collected and assessments of 24 h ambulatory BP and L-FMC were performed. Salt-resistance was defined as a change in 24 h ambulatory mean arterial pressure (MAP) between the LS and HS diets of ≤ 5 mmHg. Resting vascular tone and L-FMC were calculated from ultrasound-derived arterial diameters. RESULTS High dietary sodium increased serum sodium and urinary sodium excretion (p < 0.001 for both), but 24 h MAP was unchanged (p = 0.16) by design. High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008). CONCLUSION These findings in salt-resistant adults provide additional evidence that dietary sodium has adverse vascular effects independent of changes in BP.",2020,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008). ","['Fifteen healthy, normotensive adults (29\u2009±\u20096\xa0years', 'salt-resistant adults']","['Low-flow mediated constriction (L-FMC', '7-day low sodium (LS; 20\xa0mmol sodium/day) and 7-day high sodium (HS; 300\xa0mmol sodium/day) diet', 'High dietary sodium']","['vascular tone', 'Salt-resistance', 'blood pressure (BP', 'Resting vascular tone and L-FMC', 'ambulatory mean arterial pressure (MAP', 'serum sodium and urinary sodium excretion', 'brachial artery L-FMC']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}]",15.0,0.0307452,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008). ","[{'ForeName': 'Ninette', 'Initials': 'N', 'LastName': 'Shenouda', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. dge@udel.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04370-0'] 253,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8'] 254,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y'] 255,31293098,Acute effect of Finnish sauna bathing on brachial artery flow-mediated dilation and reactive hyperemia in healthy middle-aged and older adults.,"Regular Finnish sauna bathing is associated with a reduced risk of all-cause and cardiovascular mortality in middle-aged and older adults. Potential acute physiological adaptations induced by sauna bathing that underlie this relationship remain to be fully elucidated. The purpose of this study was to determine if typical Finnish sauna sessions acutely improve brachial artery flow-mediated dilation (FMD) and reactive hyperemia (RH) in healthy middle-aged and older adults. Using a randomized crossover design, FMD and RH were evaluated in 21 healthy adults (66 ± 6 years, 10 men/11 women) before and after each of the following conditions: (1) 1 × 10 min of Finnish sauna bathing (80.2 ± 3.2°C, 23 ± 2% humidity); (2) 2 × 10 min of sauna bathing separated by 10 min of rest outside the sauna; (3) a time control period (10 min of seated rest outside the sauna). FMD was taken as the peak change from baseline in brachial artery diameter following 5 min of forearm ischemia, whereas RH was quantified as both peak and area-under-the-curve forearm vascular conductance postischemia. FMD was statistically similar pre to post 1 × 10 min (4.69 ± 2.46 to 5.41 ± 2.64%, P = 0.20) and 2 × 10 min of sauna bathing (4.16 ± 1.79 to 4.55 ± 2.14%, P = 0.58). Peak and area-under-the-curve forearm vascular conductance were also similar following both sauna interventions. These results suggest that typical Finnish sauna bathing sessions do not acutely improve brachial artery FMD and RH in healthy middle-aged and older adults.",2019,FMD was statistically similar pre to post,"['21 healthy adults (66\xa0±\xa06\xa0years, 10 men/11 women) before and after each of the following conditions: (1) 1\xa0×\xa010\xa0min of Finnish sauna bathing (80.2\xa0±\xa03.2°C, 23\xa0±\xa02% humidity); (2', 'middle-aged and older adults', 'healthy middle-aged and older adults']","['Finnish sauna bathing on brachial artery flow-mediated dilation and reactive hyperemia', 'FMD and RH', '2\xa0×\xa010\xa0min of sauna bathing separated by 10\xa0min of rest outside the sauna; (3) a time control period (10\xa0min of seated rest outside the sauna', 'typical Finnish sauna sessions acutely improve brachial artery flow-mediated dilation (FMD) and reactive hyperemia (RH']","['Peak and area-under-the-curve forearm vascular conductance', 'brachial artery FMD and RH', 'FMD']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0004836', 'cui_str': 'Baths, Finnish'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004836', 'cui_str': 'Baths, Finnish'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}]",21.0,0.0597218,FMD was statistically similar pre to post,"[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gravel', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Geoff B', 'Initials': 'GB', 'LastName': 'Coombs', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia - Okanagan, Kelowna, Canada.'}, {'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Behzadi', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Marcoux-Clément', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Hadiatou', 'Initials': 'H', 'LastName': 'Barry', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gagnon', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, Canada.'}]",Physiological reports,['10.14814/phy2.14166'] 256,31293100,Impaired microvascular reactivity after eccentric muscle contractions is not restored by acute ingestion of antioxidants or dietary nitrate.,"Unaccustomed eccentric exercise leads to impaired microvascular function but the underlying mechanism is unknown. In this study, we evaluated the role of oxidative stress and of nitric oxide (NO) bioavailability. Thirty young men and women performed eccentric contractions of the tibialis anterior (TA) muscle (ECC), with the contralateral leg serving as nonexercising control (CON). Participants were randomized into three groups ingesting an antioxidant cocktail (AO), beetroot juice (BR) or placebo 46 h postexercise. At baseline and 48 h postexercise, hyperemic responses to brief muscle contractions and 5 min of cuff occlusion were assessed bilaterally in the TA muscles using blood oxygen level dependent (BOLD) magnetic resonance imaging. Eccentric contractions resulted in delayed time-to-peak (~22%; P < 0.001), blunted peak (~21%; P < 0.001) and prolonged time-to-half relaxation (~12%, P < 0.001) in the BOLD response to brief contractions, with no effects of AO or BR, and no changes in CON. Postocclusive time-to-peak was also delayed (~54%; P < 0.001) in ECC, with no effects of AO or BR, and no changes in CON. Impaired microvascular reactivity after eccentric contractions is confined to the exercised tissue, and is not restored with acute ingestion of AO or BR. Impairments in microvascular reactivity after unaccustomed eccentric contractions may result from structural changes within the microvasculature that can diminish muscle blood flow regulation during intermittent activities requiring prompt adjustments in oxygen delivery.",2019,"Postocclusive time-to-peak was also delayed (~54%; P < 0.001) in ECC, with no effects of AO or BR, and no changes in CON.",['Thirty young men and women performed'],"['eccentric contractions of the tibialis anterior (TA) muscle (ECC), with the contralateral leg serving as nonexercising control (CON', 'Unaccustomed eccentric exercise', 'antioxidant cocktail (AO), beetroot juice (BR) or placebo 46\xa0h postexercise']","['microvascular reactivity', 'oxidative stress and of nitric oxide (NO) bioavailability', 'Postocclusive time-to-peak', 'postexercise, hyperemic responses to brief muscle contractions and 5\xa0min of cuff occlusion', 'CON', 'blood oxygen level dependent (BOLD) magnetic resonance imaging', 'delayed time-to-peak', 'BOLD response to brief contractions', 'blunted peak', 'prolonged time-to-half relaxation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0242690', 'cui_str': 'Anterior Tibial Muscle'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0678420', 'cui_str': 'Alcoholic mixed drink'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0026820', 'cui_str': 'Muscular Contraction'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0522486', 'cui_str': 'Delay time (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",30.0,0.0618379,"Postocclusive time-to-peak was also delayed (~54%; P < 0.001) in ECC, with no effects of AO or BR, and no changes in CON.","[{'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Larsen', 'Affiliation': 'Sports Sciences, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Thomsen', 'Affiliation': 'Sports Sciences, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Rogerio P', 'Initials': 'RP', 'LastName': 'Hirata', 'Affiliation': 'Department of Health Science and Technology, SMI, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Steffensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens B', 'Initials': 'JB', 'LastName': 'Frøkjaer', 'Affiliation': 'Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, SMI, Aalborg University, Aalborg, Denmark.'}]",Physiological reports,['10.14814/phy2.14162'] 257,31301123,Effects of anodal transcranial direct current stimulation on motor evoked potentials variability in humans.,"Motor evoked potentials (MEPs) obtained from transcranial magnetic stimulation (TMS) allow corticospinal excitability (CSE) to be measured in the human primary motor cortex (M1). CSE responses to transcranial direct current stimulation (tDCS) protocols are highly variable. Here, we tested the reproducibility and reliability of individual MEPs following a common anodal tDCS protocol. In this study, 32 healthy subjects received anodal tDCS stimulation over the left M1 for three durations (tDCS-T5, tDCS-T10, and tDCS-T20 min) on separate days in a crossover-randomized order. After the resting motor threshold (RMT) was determined for the contralateral first dorsal interosseous muscle, 15 single pulses 4-8 sec apart at an intensity of 120% RMT were delivered to the left M1 to determine the baseline MEP amplitude at T 0 , T 5 , T 10 , T 20 , T 30 , T 40 , T 50 , and T 60  min after stimulation for each durations. During TMS delivery, 3D images of the participant's cortex and hot spot were visualized for obtaining MEPs from same position. Our findings revealed that there was a significant MEPs improvement at T 0 (P = 0.01) after 10 min of anodal stimulation. After the 20-min stimulation duration, MEPs differed specifically at T 0, T 5, T 30  min (P < 0.05). This indicates that tDCS is a promising tool to improve MEPs. Our observed variability in response to the tDCS protocol is consistent with other noninvasive brain stimulation studies.",2019,"After the 20-min stimulation duration, MEPs differed specifically at T 0, T 5, T 30  min","['humans', '32 healthy subjects received', 'human primary motor cortex (M1']","['anodal transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS', 'Motor evoked potentials (MEPs) obtained from transcranial magnetic stimulation (TMS', 'tDCS', 'anodal tDCS stimulation over the left M1 for three durations (tDCS-T5, tDCS-T10, and tDCS-T20\xa0min']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],32.0,0.0596944,"After the 20-min stimulation duration, MEPs differed specifically at T 0, T 5, T 30  min","[{'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Bashir', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Shafiq', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Department of Industrial Engineering, College of Engineering, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Moath', 'Initials': 'M', 'LastName': 'Alatefi', 'Affiliation': 'Department of Industrial Engineering, College of Engineering, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hamza', 'Affiliation': 'Department of Electrical Engineering, National University of Computer and Emerging Sciences, Lahore, Pakistan.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sharaf', 'Affiliation': 'Department of Industrial Engineering, College of Engineering, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Shirely', 'Initials': 'S', 'LastName': 'Fecteau', 'Affiliation': 'Medical School, Laval University, Quebec, Canada.'}, {'ForeName': 'Woo Kyoung', 'Initials': 'WK', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Hallym University Sacred Heart Hospital, Anyang, South Korea.'}]",Physiological reports,['10.14814/phy2.14087'] 258,31858673,Benefits of insulin degludec/liraglutide are maintained even in patients discontinuing sulphonylureas or dipeptidyl peptidase-4 inhibitors upon initiation of degludec/liraglutide therapy: A post hoc analysis of the DUAL II and DUAL IX trials.,"AIM To investigate the efficacy and safety of initiating insulin degludec/liraglutide (IDegLira) in patients with type 2 diabetes (T2D) who had discontinued pretrial sulphonylureas (SUs) or dipeptidyl peptidase-4 inhibitors (DPP4is) versus patients not previously treated with these regimens. MATERIALS AND METHODS In DUAL II, patients with T2D uncontrolled on basal insulin and metformin ± SU/glinides were randomized to insulin degludec or IDegLira (both capped at 50 U). In DUAL IX, patients were randomized to insulin glargine U100 (no maximum dose) or IDegLira, as add-on to sodium-glucose co-transporter-2 inhibitors ± oral antidiabetic drugs. In this post hoc analysis, patients were grouped according to pretrial use of SU (DUAL II) or DPP4i (DUAL IX). RESULTS Regardless of pretrial SU/DPP4i use, IDegLira was favourable versus insulin comparators with respect to change in HbA1c and body weight. Lower hypoglycaemia rates and comparable end-of-trial daily insulin dose were achieved with IDegLira, regardless of pretrial regimen. There was no clinically relevant increase in mean self-measured blood glucose in the early weeks after IDegLira initiation. There was no statistically significant interaction between the randomized treatments and previous SU/DPP4i use. CONCLUSIONS IDegLira was more favourable compared with degludec or glargine U100 in terms of change in HbA1c and body weight, regardless of antecedent treatment. Clinicians should be aware of a potential transient rise in self-measured blood glucose when transitioning therapy in patients. This shows that SUs/DPP4is can be safely discontinued, without deterioration in glycaemic control when initiating IDegLira, allowing a simplified treatment regimen.",2020,"Lower hypoglycaemia rates and comparable end-of-trial daily insulin dose were achieved with IDegLira, regardless of pre-trial regimen.","['patients currently using SUs or DPP4is', 'patients with type 2 diabetes (T2D) that had discontinued pre-trial sulphonylurea (SU) or dipeptidyl peptidase-4 inhibitors (DPP4is) vs patients not previously treated with these regimens', 'patients discontinuing sulphonylurea or dipeptidyl peptidase-4 inhibitor upon initiation of IDegLira therapy', 'patients with T2D uncontrolled on basal insulin and metformin ± SU/glinides']","['insulin glargine U100 (no maximum dose) or IDegLira, as add-on to sodium-glucose co-transporter-2 inhibitors ± oral antidiabetic drugs', 'DUAL II and DUAL', 'SU (DUAL II) or DPP4i (DUAL IX', 'glargine', 'insulin degludec/liraglutide (IDegLira']","['Lower hypoglycaemia rates', 'mean self-measured blood glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0406693,"Lower hypoglycaemia rates and comparable end-of-trial daily insulin dose were achieved with IDegLira, regardless of pre-trial regimen.","[{'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Janez', 'Affiliation': 'University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Őrsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stachlewska', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Salvesen-Sykes', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New, Jersey.'}, {'ForeName': 'Liana K', 'Initials': 'LK', 'LastName': 'Billings', 'Affiliation': 'NorthShore University Health System/University of Chicago Pritzker School of Medicine, Skokie, Illinois.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13944'] 259,30489011,Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.,"OBJECTIVES We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (p non-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.",2019,"Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001).","['411 patients meeting the criteria for enrolment', '287 patients were treated with the Tryton stent and 124 with PS', 'Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included']","['dedicated Tryton side branch (SB) stent', 'Provisional stenting (PS', 'Tryton-dedicated bifurcation stent', 'TVF']","['SB diameter stenosis', 'safety and efficacy', 'non-inferiority of Tryton compared with PS for target vessel failure (TVF', 'Procedural success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C4068875', 'cui_str': '2.25 (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",287.0,0.169341,"Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001).","[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Konigstein', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Srdanovic', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ankita K', 'Initials': 'AK', 'LastName': 'Gore', 'Affiliation': 'Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Hussein M', 'Initials': 'HM', 'LastName': 'Rahim', 'Affiliation': 'Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Indulis', 'Initials': 'I', 'LastName': 'Kumsars', 'Affiliation': 'Latvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': '1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Annapoorna', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Mount Sinai Medical Center, New York, New York.'}, {'ForeName': 'Géza', 'Initials': 'G', 'LastName': 'Fontos', 'Affiliation': 'Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': '2nd Department of Medicine and Cardiology Center, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Christopher Metzger', 'Affiliation': 'Wellmont CVA Heart Institute, Kingsport, Tennessee.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.27952'] 260,32020621,Effects of Therapist Feedback on the Therapeutic Alliance and Alcohol Use Outcomes in the Outpatient Treatment of Alcohol Use Disorder.,"BACKGROUND It is widely accepted that the therapeutic alliance (TA) is a mediator of psychotherapy effects, but evidence is sparse that the TA is an actual mechanism of behavior change. The purpose of this study was to provide the first systematic evidence regarding the TA as a mechanism of change in the treatment of alcohol use disorder (AUD). METHODS Participants were 155 adult men and women presenting for individual outpatient treatment of AUD. Each was randomly assigned to 1 of 6 experienced therapists, who did or did not receive over 3 study phases postsession participant feedback on his/her ratings of the TA. All participants received a 12-session version of cognitive behavioral therapy for AUD. Participants rated the TA by use of the California Psychotherapy Alliance Scale (CALPAS) and reported their daily alcohol consumption between sessions and for 1 year posttreatment by use of the timeline followback interview. Multilevel statistical models that partitioned within- and between-participant effects and between-therapist effects were run to test the effects of feedback condition on the alliance and alcohol use, and the effects of the alliance on alcohol use. RESULTS The study's main hypotheses that feedback causes an enhanced therapeutic alliance and that the alliance is associated with better alcohol use outcomes were not supported. CONCLUSIONS Several methodological and substantive reasons for the pattern of findings are suggested, as well as directions for future research that would advance study of the TA as a mechanism of change in psychotherapy and in studying therapist effects on outcomes in general.",2020,"The study's main hypotheses that feedback causes an enhanced therapeutic alliance, and that the alliance is associated with better alcohol use outcomes, were not supported. ","['outpatient treatment of alcohol use disorder', 'Participants were 155 adult men and women presenting for individual outpatient treatment of AUD']","['12-session version of cognitive behavioral therapy for AUD', '6 experienced therapists, who did or did not receive over 3 study phases post-session participant feedback on his/her ratings of the TA', 'therapist feedback']",['California Psychotherapy Alliance Scale (CALPAS) and reported their daily alcohol consumption'],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0222045'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",155.0,0.025042,"The study's main hypotheses that feedback causes an enhanced therapeutic alliance, and that the alliance is associated with better alcohol use outcomes, were not supported. ","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'From the, Department of Psychology, (SAM), Syracuse University, Syracuse, New York.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Schlauch', 'Affiliation': 'Department of Psychology, (RCS), University of South Florida, Tampa, Florida.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Connors', 'Affiliation': 'Research Institute on Addictions, (GJC, RLD, KAO), Buffalo, New York.'}, {'ForeName': 'Ronda L', 'Initials': 'RL', 'LastName': 'Dearing', 'Affiliation': 'Research Institute on Addictions, (GJC, RLD, KAO), Buffalo, New York.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': ""O'Hern"", 'Affiliation': 'Research Institute on Addictions, (GJC, RLD, KAO), Buffalo, New York.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14297'] 261,32305099,"Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial.","BACKGROUND State-of-the art therapy for recurrent ovarian cancer suitable for platinum-based re-treatment includes bevacizumab-containing combinations (eg, bevacizumab combined with carboplatin-paclitaxel or carboplatin-gemcitabine) or the most active non-bevacizumab regimen: carboplatin-pegylated liposomal doxorubicin. The aim of this head-to-head trial was to compare a standard bevacizumab-containing regimen versus carboplatin-pegylated liposomal doxorubicin combined with bevacizumab. METHODS This multicentre, open-label, randomised, phase 3 trial, was done in 159 academic centres in Germany, France, Australia, Austria, and the UK. Eligible patients (aged ≥18 years) had histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with first disease recurrence more than 6 months after first-line platinum-based chemotherapy, and an Eastern Cooperative Oncology Group performance status of 0-2. Patients were stratified by platinum-free interval, residual tumour, previous antiangiogenic therapy, and study group language, and were centrally randomly assigned 1:1 using randomly permuted blocks of size two, four, or six to receive six intravenous cycles of bevacizumab (15 mg/kg, day 1) plus carboplatin (area under the concentration curve [AUC] 4, day 1) plus gemcitabine (1000 mg/m 2 , days 1 and 8) every 3 weeks or six cycles of bevacizumab (10 mg/kg, days 1 and 15) plus carboplatin (AUC 5, day 1) plus pegylated liposomal doxorubicin (30 mg/m 2 , day 1) every 4 weeks, both followed by maintenance bevacizumab (15 mg/kg every 3 weeks in both groups) until disease progression or unacceptable toxicity. There was no masking in this open-label trial. The primary endpoint was investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1. Efficacy data were analysed in the intention-to-treat population. Safety was analysed in all patients who received at least one dose of study drug. This completed study is registered with ClinicalTrials.gov, NCT01837251. FINDINGS Between Aug 1, 2013, and July 31, 2015, 682 eligible patients were enrolled, of whom 345 were randomly assigned to receive carboplatin-pegylated liposomal doxorubicin-bevacizumab (experimental group) and 337 were randomly assigned to receive carboplatin-gemcitabine-bevacizumab (standard group). Median follow-up for progression-free survival at data cutoff (July 10, 2018) was 12·4 months (IQR 8·3-21·7) in the experimental group and 11·3 months (8·0-18·4) in the standard group. Median progression-free survival was 13·3 months (95% CI 11·7-14·2) in the experimental group versus 11·6 months (11·0-12·7) in the standard group (hazard ratio 0·81, 95% CI 0·68-0·96; p=0·012). The most common grade 3 or 4 adverse events were hypertension (88 [27%] of 332 patients in the experimental group vs 67 [20%] of 329 patients in the standard group) and neutropenia (40 [12%] vs 73 [22%]). Serious adverse events occurred in 33 (10%) of 332 patients in the experimental group and 28 (9%) of 329 in the standard group. Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage). INTERPRETATION Carboplatin-pegylated liposomal doxorubicin-bevacizumab is a new standard treatment option for platinum-eligible recurrent ovarian cancer. FUNDING F Hoffmann-La Roche.",2020,"Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage). ","['Patients were stratified by platinum-free interval, residual tumour, previous antiangiogenic therapy, and study group language', '159 academic centres in Germany, France, Australia, Austria, and the UK', 'Between Aug 1, 2013, and July 31, 2015', '682 eligible patients were enrolled, of whom 345', 'recurrent ovarian cancer', 'platinum-eligible recurrent ovarian cancer', 'Eligible patients (aged ≥18 years) had histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with first disease recurrence more than 6 months after first-line platinum-based chemotherapy, and an Eastern Cooperative Oncology Group performance status of 0-2']","['doxorubicin ', 'Carboplatin-pegylated liposomal doxorubicin-bevacizumab', 'carboplatin-pegylated liposomal doxorubicin-bevacizumab', 'gemcitabine', 'carboplatin', 'bevacizumab regimen: carboplatin-pegylated liposomal doxorubicin', 'bevacizumab', 'Bevacizumab and platinum-based combinations', 'carboplatin-gemcitabine-bevacizumab', 'bevacizumab-containing combinations (eg, bevacizumab combined with carboplatin-paclitaxel or carboplatin-gemcitabine', 'standard bevacizumab-containing regimen versus carboplatin-pegylated liposomal doxorubicin combined with bevacizumab', 'carboplatin (AUC 5, day 1) plus pegylated liposomal']","['large intestine perforation', 'osmotic demyelination syndrome and intracranial haemorrhage', 'Safety', 'neutropenia', 'Serious adverse events', 'deaths', 'Median progression-free survival', 'investigator-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}]","[{'cui': 'C0151738', 'cui_str': 'Perforation of large intestine'}, {'cui': 'C2721559', 'cui_str': 'Osmotic demyelination syndrome'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",682.0,0.197238,"Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage). ","[{'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Pfisterer', 'Affiliation': 'Gynaecologic Oncology Center, Kiel, Germany. Electronic address: jacobus.pfisterer@googlemail.com.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Shannon', 'Affiliation': 'Oncology Department, Mater Cancer Care Centre, Brisbane, QLD, Australia.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Baumann', 'Affiliation': 'Gynaecology Department, Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Germany.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Rau', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Gynaecology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynaecology, and European Competence Center for Ovarian Cancer, Charité - Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': 'Department of Gynaecology, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': 'Technical University of Munich-Klinikum Rechts der Isar, Germany; Department of Gynaecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Dean', 'Affiliation': 'Gynaecological Oncology Department, St John of God Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hein', 'Affiliation': 'Gynaecology Department, Erlangen University Hospital, Erlangen, Germany.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Zeimet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Lars C', 'Initials': 'LC', 'LastName': 'Hanker', 'Affiliation': 'Gynaecology Department, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Petit', 'Affiliation': 'Paul Strauss Cancer Center and Gynaecology Department, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Gynaecology Department, National Center for Tumor Disease, University of Heidelberg, Heidelberg, Germany; Department of Gynaecology and Obstetrics, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Balat', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Frankfurt/Main, Frankfurt, Germany.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Glasspool', 'Affiliation': 'National Cancer Research Institute, Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Gynaecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Obstetrics and Gynaecology, University Hospital, Ludwig-Maximilian-University, Munich, Germany.'}, {'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'Meniawy', 'Affiliation': 'Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Tjoung-Won', 'Initials': 'TW', 'LastName': 'Park-Simon', 'Affiliation': 'Department of Gynaecology and Obstetrics, Medical University Hannover, Hannover, Germany.'}, {'ForeName': 'Marie-Ange', 'Initials': 'MA', 'LastName': 'Mouret-Reynier', 'Affiliation': 'Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Costan', 'Affiliation': 'Department of Oncology, Hôpital Michallon, Grenoble, France.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Department of Gynaecology and Obstetrics, Evangelisches Krankenhaus Düsseldorf, Germany; Department of Gynaecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Comprehensive Cancer Centre, University Hospital for Gynaecology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Tifenn', 'Initials': 'T', 'LastName': ""L'Haridon"", 'Affiliation': 'Centre Hospitalier Départemental les Oudairies, La Roche-Sur-Yon, France.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Baron Hay', 'Affiliation': ""Women's Health, Royal North Shore Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kommoss', 'Affiliation': ""Department of Women's Health, Tübingen University Hospital, Tübingen, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Kurtz', 'Affiliation': 'Haematology-Oncology Department, Centre Hospitalier Régional et Universitaire de Strasbourg Hôpital Civil, Strasbourg, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30142-X'] 262,31204129,Single-dose cardioplegia protects myocardium as well as traditional repetitive dosing: A noninferiority randomized study.,"OBJECTIVE The present prospective noninferiority randomized trial was designed to demonstrate the safety and efficacy of a single dose of Custodiol histidine-tryptophan-ketoglutarate compared with repetitive cold-blood cardioplegia. METHODS From October 2012 to May 2014, 110 patients were randomly assigned to 1 of 2 groups: Group 1 (55 patients) received repetitive cold-blood cardioplegia, and group 2 (55 patients) received single-dose Custodiol histidine-tryptophan-ketoglutarate. Isolated aortic valve replacement, isolated mitral valve replacement, and multivalve procedures represented the most frequent operations, with 39 cases (71%) in group 1 and 49 cases (89%) in group 2. There was no difference in cardiopulmonary bypass time (102 ± 26 minutes vs 99 ± 19 minutes, P = .70) or aortic crossclamp time (77 ± 19 minutes vs 74 ± 17 minutes, P = .33). All patients underwent preoperative electrocardiogram and determination of creatine kinase-MB, troponin I, left ventricular ejection fraction, and regional wall motion. Postoperative cardiac biomarkers were checked at 7, 24, and 48 hours, and an echocardiogram was obtained to check for left ventricular function abnormalities. RESULTS There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23). Left ventricular function was similar between groups preoperatively and at 24 hours after surgery. No death or myocardial infarction was observed in either group. There were no differences in intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels. CONCLUSIONS A single dose of Custodiol histidine-tryptophan-ketoglutarate cardioplegia is not inferior to repeated cold-blood cardioplegia during elective cardiac surgery.",2020,"There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23).","['110 patients', 'From October 2012 to May 2014']","['preoperative electrocardiogram and determination of creatine kinase-MB, troponin', 'Custodiol histidine-tryptophan-ketoglutarate', 'single-dose Custodiol histidine-tryptophan-ketoglutarate', 'repetitive cold-blood cardioplegia', 'Custodiol histidine-tryptophan-ketoglutarate cardioplegia']","['safety and efficacy', 'cardiac biomarkers release', 'cardiopulmonary bypass time (102\xa0±', 'death or myocardial infarction', 'intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels', 'Left ventricular function', 'aortic crossclamp time', 'Postoperative cardiac biomarkers']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0019602', 'cui_str': 'L-histidine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0005768'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",110.0,0.115447,"There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Vivacqua', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich. Electronic address: Alessandro.Vivacqua@beaumont.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Mich.'}, {'ForeName': 'Amr E', 'Initials': 'AE', 'LastName': 'Abbas', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Altshuler', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}, {'ForeName': 'Francis L', 'Initials': 'FL', 'LastName': 'Shannon', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Podolsky', 'Affiliation': 'Beaumont Research Institute, Royal Oak, Mich.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Sakwa', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.03.125'] 263,31944251,Responsiveness and Interpretability of 2 Measures of Physical Function in Patients With Spondyloarthritis.,"BACKGROUND Maintenance or improvement of physical function is an important treatment target in the management of patients with axial spondyloarthritis (axSpA); measurement tools that can detect changes in physical function are therefore important. OBJECTIVES The objective of this study was to compare responsiveness and interpretability of the patient-reported Bath Ankylosing Spondylitis Functional Index (BASFI) and the Ankylosing Spondylitis Performed-Based Improvement (ASPI) in measuring change in physical function after exercise in patients with axSpA. DESIGN This was a sub-study of 58 patients nested within a randomized controlled trial comparing the effect of 12 weeks of exercise with usual care. METHODS Responsiveness and interpretability were assessed according to the Consensus-based Standards for the selection of health status Measurement Instrument. Responsiveness was assessed by testing 8 predefined hypotheses for ASPI and BASFI. Interpretability was assessed by: (1) using patients' reported change as an anchor (""a little better"" = minimal important change) and (2) by categorizing patients with a 20% improvement as responders. RESULTS For ASPI and BASFI, 5 of 8 (63%) versus 2 of 8 (25%) of the predefined hypotheses for responsiveness were confirmed. The minimal important change values for improvement in physical function were 3.7 seconds in ASPI and 0.8 points (on a scale from 0 to 10) for BASFI. In the intervention group, 21 of 30 (70%) and 13 of 30 (43%) of the patients were categorized as responders measured with ASPI and BASFI, respectively. There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline. LIMITATIONS This study was limited by its moderate sample size. CONCLUSIONS Our findings suggest that ASPI is preferable over BASFI when evaluating physical function after exercise interventions in patients with axSpA.",2020,"There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline. ","['patients with axSpA', 'Patients With Spondyloarthritis', 'patients with axSpA.\nDESIGN', 'patients with axial spondyloarthritis (axSpA', '58 patients nested']","['12-weeks exercise with usual care', 'BASFI', 'ASPI']","['Interpretability', 'responsiveness and interpretability of the patient reported Bath Ankylosing Spondylitis (AS) Functional Index (BASFI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150141'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0536311,"There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline. ","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fongen', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Dagfinrud', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Bilberg', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, and Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Melissa Woll', 'Initials': 'MW', 'LastName': 'Johansen', 'Affiliation': 'Department of Rheumatology, Martina Hansens Hospital, Bærum, Norway.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'van Weely', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Kåre Birger', 'Initials': 'KB', 'LastName': 'Hagen', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Silje Halvorsen', 'Initials': 'SH', 'LastName': 'Sveaas', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway.'}]",Physical therapy,['10.1093/ptj/pzaa004'] 264,31944252,A Randomized Controlled Trial Assessing the Evolution of the Weight-Bearing Ankle Dorsiflexion Range of Motion Over 6 Sessions of Talus Mobilizations in Older Adults.,"BACKGROUND Ankle range of motion declines with age, affecting mobility and postural control. OBJECTIVE The objective of this study was to investigate the effects of a talus mobilization-based intervention among healthy community-dwelling older adults presenting with limited weight-bearing ankle dorsiflexion range of motion and determine how ankle mobility evolved over the treatment. DESIGN This was a randomized clinical trial. SETTING This study was conducted in an outpatient clinic. PARTICIPANTS Community-dwelling, older adults over 60 years of age who had limited ankle mobility participated in this study. INTERVENTIONS The experimental intervention consisted of 6 sessions of manual therapy applied in the ankle joint. The control group received the same volume of sham treatment. MEASUREMENTS The primary outcome was the weight-bearing ankle dorsiflexion range of motion as measured using the lunge test. Data were collected at 9 time points: baseline, after each session, and follow-up. RESULTS A total of 36 participants were analyzed. A single session of mobilization increased ankle range of motion by 8 degrees (95% confidence interval = 6 to 11). At the end of the sixth session, this effect had increased slightly to 11 degrees (95% confidence interval = 9 to 13). Significant between-group differences were found throughout the intervention. LIMITATIONS Optimal dose and effects from follow-up evaluations for treatment volumes of fewer than 6 sessions remain unknown. CONCLUSIONS Six sessions of a talus mobilization-based intervention in healthy community-dwelling older adults found that the greatest mobility gain in terms of the weight-bearing ankle dorsiflexion range of motion is produced after the first session. Additional sessions produce smaller improvements with a slight upward trend. Importantly, the restoration of joint mobility is enhanced over time after the end of the intervention.",2020,The primary outcome was the weight-bearing ankle dorsiflexion range of motion as measured using the lunge test.,"['Thirty-six participants were analyzed', 'Older Adults', 'outpatient clinic', 'healthy community-dwelling older adults presenting with limited weight-bearing ankle dorsiflexion range of motion', 'healthy community-dwelling older adults', 'Community-dwelling, older adults over age 60 who had limited ankle mobility participated in this study']","['Weight-Bearing Ankle Dorsiflexion Range of Motion', 'talus mobilization-based intervention']","['weight-bearing ankle dorsiflexion range of motion as measured using the lunge test', 'joint mobility']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0039277', 'cui_str': 'Astragalus Bone'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",36.0,0.100207,The primary outcome was the weight-bearing ankle dorsiflexion range of motion as measured using the lunge test.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hernández-Guillén', 'Affiliation': 'Group in Physiotherapy in the Ageing Process, Social and Health Care Strategies, Department of Physiotherapy, University of Valencia, Calle Gascó Oliag 5, 46010 Valencia, Spain.'}, {'ForeName': 'José-María', 'Initials': 'JM', 'LastName': 'Blasco', 'Affiliation': 'Group in Physiotherapy in the Ageing Process, Social and Health Care Strategies, Department of Physiotherapy, University of Valencia.'}]",Physical therapy,['10.1093/ptj/pzaa003'] 265,30362250,Day-to-day fasting self-monitored blood glucose variability is associated with risk of hypoglycaemia in insulin-treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials.,"AIMS To investigate the association between day-to-day fasting self-monitored blood glucose (SMBG) variability and risk of hypoglycaemia in type 1 (T1D) and type 2 diabetes (T2D), and to compare day-to-day fasting SMBG variability between treatments with insulin degludec (degludec) and insulin glargine 100 units/mL (glargine U100). MATERIALS AND METHODS Data were retrieved from two double-blind, randomized, treat-to-target, two-period (32 weeks each) crossover trials of degludec vs glargine U100 in T1D (SWITCH 1, n = 501) and T2D (SWITCH 2, n = 720). Available fasting SMBGs were used to determine the standard deviation (SD) of day-to-day fasting SMBG variability for each patient and the treatment combination. The association between day-to-day fasting SMBG variability and overall symptomatic, nocturnal symptomatic and severe hypoglycaemia was analysed for the pooled population using linear regression, with fasting SMBG variability included as a three-level factor defined by population tertiles. Finally, day-to-day fasting SMBG variability was compared between treatments. RESULTS Linear regression showed that day-to-day fasting SMBG variability was significantly associated with overall symptomatic, nocturnal symptomatic and severe hypoglycaemia risk in T1D and T2D (P < 0.05). Day-to-day fasting SMBG variability was significantly associated (P < 0.01) with all categories of hypoglycaemia risk, with the exception of severe hypoglycaemia in T2D when analysed within tertiles. Degludec was associated with 4% lower day-to-day fasting SMBG variability than glargine U100 in T1D (P = 0.0082) and with 10% lower day-to-day fasting SMBG variability in T2D (P < 0.0001). CONCLUSIONS Higher day-to-day fasting SMBG variability is associated with an increased risk of overall symptomatic, nocturnal symptomatic and severe hypoglycaemia. Degludec has significantly lower day-to-day fasting SMBG variability vs glargine U100.",2019,"Degludec was associated with 4% lower day-to-day fasting SMBG variability than glargine U100 in T1D (P = 0.0082) and with 10% lower day-to-day fasting SMBG variability in T2D (P < 0.0001). ",['insulin-treated patients with type 1 and type 2 diabetes'],"['insulin degludec (degludec) and insulin glargine', 'degludec vs glargine U100 in T1D']","['fasting SMBG variability and overall symptomatic, nocturnal symptomatic and severe hypoglycaemia', 'overall symptomatic, nocturnal symptomatic and severe hypoglycaemia risk in T1D and T2D', 'fasting SMBG variability', 'risk of overall symptomatic, nocturnal symptomatic and severe hypoglycaemia', 'blood glucose (SMBG) variability and risk of hypoglycaemia in type 1 (T1D) and type 2 diabetes (T2D']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",720.0,0.0302972,"Degludec was associated with 4% lower day-to-day fasting SMBG variability than glargine U100 in T1D (P = 0.0082) and with 10% lower day-to-day fasting SMBG variability in T2D (P < 0.0001). ","[{'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'DeVries', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Bailey', 'Affiliation': 'AMCR Institute, Escondido, California.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes and Endocrinology Research Center, Des Moines, Iowa.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Gerety', 'Affiliation': 'Albany Medical College, Albany, New York.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Gumprecht', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lane', 'Affiliation': 'Mountain Diabetes and Endocrine Center, Asheville, North Carolina.'}, {'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Wysham', 'Affiliation': 'Rockwood Clinic, Spokane, Washington.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Bak', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hachmann-Nielsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13565'] 266,31375753,A Randomised Controlled Trial on the Effectiveness and Adherence of Modified Alternate-day Calorie Restriction in Improving Activity of Non-Alcoholic Fatty Liver Disease.,"Currently, there is no effective therapy for non-alcoholic fatty liver disease (NAFLD), although intensive calorie restriction is typically recommended but dietary adherence is an issue. The current study aimed to determine the effectiveness and adherence of eight weeks of modified alternate-day calorie restriction (MACR) in the control of NAFLD activity. This was a randomized controlled trial with MACR as the intervention and normal habitual diet as control. The outcome measures were body mass index (BMI), blood lipids, fasting blood sugar (FBS), liver enzymes (ALT and AST), and ultrasonographic measurements of liver steatosis and shear wave elastography (SWE). Per-protocol (PP) and intention-to-treat (ITT) analysis were performed within and between-groups with P < 0.05 as significant. 43 individuals with NAFLD satisfied study entry criteria, 33 were randomized to MACR and 10 to control group, and, 30 from MACR and 9 from control group completed PP. In between-group analysis of MACR vs. control, BMI were reduced in PP (P = 0.02) and ITT (P = 0.04). Only ALT was reduced in between-group analysis of MACR vs. control, both PP and ITT (P = 0.02 and 0.04 respectively). No reductions in all lipid parameters and FBS were found in between-group analyses (PP and ITT, all P > 0.22). Both liver steatosis grades and fibrosis (SWE) scores were reduced in between-group analyses of MACR vs. controls (PP and ITT, all P < 0.01). Adherence level remained between 75-83% throughout the study. As conclusion, 8 weeks of MACR protocol appears more effective than usual habitual diet in the control of NAFLD activity and with good adherence rate.",2019,"Both liver steatosis grades and fibrosis (SWE) scores were reduced in between-group analyses of MACR vs. controls (PP and ITT, all P < 0.01).","['Non-Alcoholic Fatty Liver Disease', '43 individuals with NAFLD satisfied study entry criteria, 33 were randomized to']","['modified alternate-day calorie restriction (MACR', 'MACR', 'Modified Alternate-day Calorie Restriction']","['liver steatosis grades and fibrosis (SWE) scores', 'body mass index (BMI), blood lipids, fasting blood sugar (FBS), liver enzymes (ALT and AST), and ultrasonographic measurements of liver steatosis and shear wave elastography (SWE', 'Per-protocol (PP) and intention-to-treat (ITT) analysis', 'Adherence level', 'lipid parameters and FBS']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",43.0,0.0659386,"Both liver steatosis grades and fibrosis (SWE) scores were reduced in between-group analyses of MACR vs. controls (PP and ITT, all P < 0.01).","[{'ForeName': 'Muhammad Izzad', 'Initials': 'MI', 'LastName': 'Johari', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairiah', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Juhara', 'Initials': 'J', 'LastName': 'Haron', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Chandran', 'Initials': 'C', 'LastName': 'Nadarajan', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairun Nisah', 'Initials': 'KN', 'LastName': 'Ibrahim', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Muhammad Ilham Abdul', 'Initials': 'MIA', 'LastName': 'Hafidz', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Bee Eng', 'Initials': 'BE', 'LastName': 'Chua', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Nurhazwani', 'Initials': 'N', 'LastName': 'Hamid', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Wan Nor', 'Initials': 'WN', 'LastName': 'Arifin', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia. yylee@usm.my.'}]",Scientific reports,['10.1038/s41598-019-47763-8'] 267,32305379,Sensorimotor performance is improved by targeted memory reactivation during a daytime nap in healthy older adults.,"Sensorimotor consolidation occurs during sleep. However, the benefit of sleep-based consolidation decreases with age due to decreased sleep quality and quantity. This study aimed to enhance sensorimotor performance through repetitive delivery of task-based auditory cues during sleep, known as targeted memory reactivation (TMR). Healthy older adults performed a non-dominant arm throwing task before and after a 1 h nap. While napping, half of participants received TMR throughout the hour. Participants who received TMR during sleep demonstrated a greater overall change in throwing accuracy from the start of the first to the end of the second throwing task session. However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task. Findings support the use of TMR during sleep to enhance task-specific sensorimotor performance in healthy older adults despite age-related decreases in sleep quality and quantity. Future research is needed to evaluate the effects of TMR on rehabilitation protocols.",2020,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","['Healthy older adults', 'healthy older adults']","['task-based auditory cues', 'TMR']",['sleep quality and quantity'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",,0.0188997,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Scharf', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Avelino C', 'Initials': 'AC', 'LastName': 'Verceles', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Westlake', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States. Electronic address: kwestlake@som.umaryland.edu.'}]",Neuroscience letters,['10.1016/j.neulet.2020.134973'] 268,31947920,Implementation of a Pharmacist-Led Transitions of Care Program within a Primary Care Practice: A Two-Phase Pilot Study.,"Pharmacists in primary care settings have unique opportunities to address the causes of ineffective care transitions. The objective of this study is to describe the implementation of a multifaceted pharmacist transitions of care (TOC) intervention integrated into a primary care practice and evaluate the effectiveness of the program. This was a two-phase pilot study describing the development, testing, and evaluation of the TOC program. In Phase 1, the TOC intervention was implemented in a general patient population, while Phase 2 focused the intervention on high-risk patients. The two pilot phases were compared to each other (Phase 1 vs. Phase 2) and to a historical control group of patients who received usual care prior to the intervention (Phase 1 and Phase 2 vs. control). The study included 138 patients in the intervention group (Phase 1: 101 and Phase 2: 37) and 118 controls. At baseline, controls had a significantly lower LACE index, shorter length of stay, and a lower number of medications at discharge, indicating less medical complexity. A total of 344 recommendations were provided over both phases, approximately 80% of which were accepted. In adjusted models, there were no significant differences in 30-day all-cause readmissions between Phase 2 and controls (aOR 0.78; 95% CI 0.21-2.89; p = 0.71) or Phase 1 (aOR 0.99; 95% CI 0.30-3.37; p = 0.99). This study successfully implemented a pharmacist-led TOC intervention within a primary care setting using a two-phase pilot design. More robust studies are needed in order to identify TOC interventions that reduce healthcare utilization in a cost-effective manner.",2020,"At baseline, controls had a significantly lower LACE index, shorter length of stay, and a lower number of medications at discharge, indicating less medical complexity.","['within a Primary Care Practice', '138 patients in the intervention group (Phase 1: 101 and Phase 2: 37) and 118 controls']","['pharmacist-led TOC intervention', 'usual care prior to the intervention (Phase 1 and Phase 2 vs. control', 'TOC intervention', 'multifaceted pharmacist transitions of care (TOC) intervention', 'Care Program']","['30-day all-cause readmissions', 'LACE index, shorter length of stay']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0453991', 'cui_str': 'Laces (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",138.0,0.0211272,"At baseline, controls had a significantly lower LACE index, shorter length of stay, and a lower number of medications at discharge, indicating less medical complexity.","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Slazak', 'Affiliation': 'Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY 14214, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shaver', 'Affiliation': 'Department of Epidemiology and Environment Health, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY 14214, USA.'}, {'ForeName': 'Collin M', 'Initials': 'CM', 'LastName': 'Clark', 'Affiliation': 'Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY 14214, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cardinal', 'Affiliation': 'General Physicians, P.C., Buffalo, NY 14214, USA.'}, {'ForeName': 'Merin', 'Initials': 'M', 'LastName': 'Panthapattu', 'Affiliation': 'Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY 14214, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Prescott', 'Affiliation': 'Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY 14214, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Will', 'Affiliation': 'General Physicians, P.C., Buffalo, NY 14214, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY 14214, USA.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8010004'] 269,32255473,"Øberg GK, Girolami GL, Campbell SK, et al. Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial. [Published online ahead of print January 16, 2020]. Phys Ther. 2020. DOI: 10.1093/ptj/pzaa014.",,2020,,['Neonatal Intensive Care Unit'],"['Parent-Administered Exercise Program', 'DOI']",[],"[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.085487,,"[{'ForeName': 'Gunn Kristin', 'Initials': 'GK', 'LastName': 'Øberg', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, PB 6050 Langnes, Tromsø, 9037 Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway, Tromsø, Norway.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Suzann K', 'Initials': 'SK', 'LastName': 'Campbell', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Tordis', 'Initials': 'T', 'LastName': 'Ustad', 'Affiliation': 'Department of Clinical Services, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Ivar', 'Initials': 'I', 'LastName': 'Heuch', 'Affiliation': 'Department of Mathematics, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjarne K', 'Initials': 'BK', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Centre for Sami Health Research, Department of Community Medicine, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Per Ivar', 'Initials': 'PI', 'LastName': 'Kaaresen', 'Affiliation': 'Pediatric and Adolescent Department, University Hospital North Norway; and Department of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Vibeke Smith', 'Initials': 'VS', 'LastName': 'Aulie', 'Affiliation': 'Section of Physiotherapy, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway.'}]",Physical therapy,['10.1093/ptj/pzaa026'] 270,31899491,Effect of Senior Dance (DanSE) on Fall Risk Factors in Older Adults: A Randomized Controlled Trial.,"BACKGROUND Older people's participation in structured exercise programs to improve balance and mobility is low. Senior Dance is an alternative option, as it may provide a safe and fun way of targeting balance. OBJECTIVE The aim was to investigate the effect of Senior Dance on balance, mobility, and cognitive function compared with a control intervention. DESIGN The study was a randomized controlled trial. SETTING/PATIENTS Eighty-two community-dwelling older people aged 60 years or over and cognitively intact were recruited in Brazil. INTERVENTION Participants were randomly allocated to 2 groups: Dance plus education (intervention group) and education alone (control group). The Senior Dance program consisted of 12 weeks of twice-weekly group-based dance classes. Participants in both groups attended a single 1-hour educational session on prevention of falls. MEASUREMENTS The primary outcome was single-leg stance with eyes closed. Secondary outcomes were timed sit-to-stand test, standing balance test, timed 4-m walk, and cognitive function tests, for example, Trail Making Test and Montreal Cognitive Assessment. RESULTS Of the 82 participants randomized, 71 (87%) completed the 12-week follow-up. Single-leg stance with eyes closed (primary outcome) improved in the Senior Dance group (mean difference [MD] = 2.3 seconds, 95% confidence interval [CI] = 1.1 to 3.6) compared with the control group at follow-up. Senior Dance group performed better in the standing balance tests (MD = 3.7 seconds, 95% CI = 0.6 to 6.8) and were faster in the sit-to-stand test (MD = - 3.1 seconds, 95% CI = -4.8 to -1.4) and 4-m walk test (MD = -0.6 seconds, 95% CI = -1.0 to -0.1). There were no significant between-group differences for cognitive function tests. LIMITATIONS Participants and therapists were not blinded. CONCLUSION Senior Dance was effective in improving balance and mobility but not cognitive function in community-dwelling older people.",2020,"Senior Dance group performed better in the standing balance tests (MD = 3.7 seconds, 95% CI: 0.6 to 6.8), were faster in the sit-to-stand test (MD = - 3.1 seconds, 95% CI: -4.8 to -1.4), and 4-meter walk test (MD = ","['Of the 82 participants randomized, 71 (87%) completed the 12-week follow-up', 'Eighty-two community-dwelling older people aged 60\xa0years or over and cognitively intact were recruited in Brazil', 'community-dwelling older people', 'Older Adults']","['Senior Dance (DanSE', 'structured exercise programs', 'Senior Dance plus education (intervention group) and education alone (control group']","['balance, mobility, and cognitive function', 'Fall Risk Factors', 'cognitive function tests', 'single-leg stance with eyes closed', 'balance and mobility', 'timed sit-to-stand test, standing balance test, timed 4-meter walk, and cognitive function tests, eg, Trail Making test and Montreal Cognitive Assessment']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3496286'}]",82.0,0.111345,"Senior Dance group performed better in the standing balance tests (MD = 3.7 seconds, 95% CI: 0.6 to 6.8), were faster in the sit-to-stand test (MD = - 3.1 seconds, 95% CI: -4.8 to -1.4), and 4-meter walk test (MD = ","[{'ForeName': 'Marcia R', 'Initials': 'MR', 'LastName': 'Franco', 'Affiliation': 'Department of Physical Therapy, Centro Universitário UNA, Minas Gerais, Brazil; Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil; Department of Physical Therapy, Regional Public Hospital of Betim, Minas Gerais, Brazil.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney.'}, {'ForeName': 'Leani S', 'Initials': 'LS', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Monica R', 'Initials': 'MR', 'LastName': 'Perracini', 'Affiliation': 'Department of Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Claudia S G', 'Initials': 'CSG', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil.'}, {'ForeName': 'Ruben F', 'Initials': 'RF', 'LastName': 'Negrão-Filho', 'Affiliation': 'Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil.'}, {'ForeName': 'Rafael Z', 'Initials': 'RZ', 'LastName': 'Pinto', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Pastre', 'Affiliation': 'Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil.'}]",Physical therapy,['10.1093/ptj/pzz187'] 271,31899499,The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial.,"BACKGROUND Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures. OBJECTIVE This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures. DESIGN This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups. SETTING This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers. PARTICIPANTS This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures. INTERVENTION A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise ≥3 times weekly. Controls received equal attention. MEASUREMENTS Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses. RESULTS There was a small effect of exercise on 5 times sit-to-stand test versus control (MD = -1.58 [95% CI = -3.09 to -0.07], intention-to-treat; MD = -1.49 [95% CI = -3.12 to 0.16], per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time. LIMITATIONS Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses. CONCLUSIONS Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.",2020,There was a small effect of exercise on five times sit-to-stand test versus control (MD:,"['patients after vertebral fractures', '141 women ≥65\xa0years with radiographically confirmed vertebral fractures', 'individuals with vertebral fractures', '5 Canadian and 2 Australian academic or community hospitals/centers', 'Older Women With Vertebral Fractures']","['control (MD', 'equal attention', 'home exercise versus control', 'exercise', 'physical therapist delivered exercise and behavioral counseling', 'Home Exercise', 'exercise or attentional control groups']","['Adherence', 'functional leg muscle strength', 'Functional performance, posture, quality of life, pain and behavior-change outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3853978'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",141.0,0.179121,There was a small effect of exercise on five times sit-to-stand test versus control (MD:,"[{'ForeName': 'Jenna C', 'Initials': 'JC', 'LastName': 'Gibbs', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada; and GERAS Centre for Aging Research, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Wark', 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, Victoria, Australia; and Bone and Mineral Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Samuel C', 'Initials': 'SC', 'LastName': 'Scherer', 'Affiliation': 'Department of Medicine, University of Melbourne; Royal Melbourne Hospital; and Broadmeadows Health Services, Northern Health, Melbourne, Australia.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Medicine, McMaster University; GERAS Centre for Aging Research, Hamilton Health Sciences; and Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mittmann', 'Affiliation': 'Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Laprade', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada; and Ontario Osteoporosis Strategy, Osteoporosis Canada, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ""Department of Medicine, University of Toronto; and Centre for Osteoporosis and Bone Health, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Grad Dip Physio, BAppSc (Physio), School of Primary and Allied Health Care, Peninsula Campus, Monash University, Frankston, Australia.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Toronto; and Osteoporosis Program and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bleakney', 'Affiliation': 'Department of Medical Imaging, University of Toronto; and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System.'}, {'ForeName': 'Maureen C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'Department of Family Practice, University of British Columbia; and Centre for Hip Health and Mobility, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Adachi', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'Lora M', 'Initials': 'LM', 'LastName': 'Giangregorio', 'Affiliation': 'Department of Kinesiology, University of Waterloo; and Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada; and KITE, Toronto Rehab-University Health Network, Toronto, Ontario, Canada.'}]",Physical therapy,['10.1093/ptj/pzz188'] 272,31288028,SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial.,"BACKGROUND AND AIMS Viscous solutions provide a superior submucosal cushion for EMR. SIC-8000 (Eleview; Aries Pharmaceuticals, La Jolla, Calif) is a commercially available U.S. Food and Drug Administration-approved solution, but hetastarch is also advocated. We performed a randomized trial comparing SIC-8000 with hetastarch as submucosal injection agents for colorectal EMR. METHODS This was a single-center, double-blinded, randomized controlled trial performed at a tertiary referral center. Patients were referred to our center with flat or sessile lesions measuring ≥15 mm in size. The primary outcome measures were the Sydney resection quotient (SRQ) and the rate of en bloc resections. Secondary outcomes were total volume needed for a sufficient lift, number of resected pieces, and adverse events. RESULTS There were 158 patients with 159 adenomas (SIC-8000, 84; hetastarch, 75) and 57 serrated lesions (SIC-8000, 30; hetastarch, 27). SRQ was significantly better in the SIC-8000 group compared with hetastarch group (9.3 vs 8.1, P = .001). There was no difference in the proportion of lesions with en bloc resections. The total volume of injectate was significantly lower with SIC-8000 (14.8 mL vs 20.6 mL, P = .038). CONCLUSIONS SIC-8000 is superior to hetastarch for use during EMR in terms of SRQ and total volume needed, although the absolute differences were small. (Clinical trial registration number: NCT03350217.).",2019,"SIC-8000 is superior to hetastarch for use during EMR in terms of SRQ and total volume needed, although the absolute differences were small.","['endoscopic mucosal resection', '158 patients with 159 adenomas (84 SIC-8000 and 75 hetastarch) and 57 serrated lesions (30 SIC-8000 and 27 hetastarch', 'Patients were referred to our center with flat or sessile lesions measuring ≥15 mm in size']","['SIC-8000 ', 'hetastarch', 'SIC-8000 versus hetastarch', 'SIC-8000 to hetastarch']","['Sydney Resection Quotient (SRQ) and the rate of en bloc resections', 'SRQ', 'total volume of injectate', 'proportion of lesions with en bloc resections', 'total volume needed for a sufficient lift, number of resected pieces, and adverse events']","[{'cui': 'C1700928', 'cui_str': 'Endoscopic Mucous Membrane Resection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C3840857', 'cui_str': '8000 (qualifier value)'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C3840857', 'cui_str': '8000 (qualifier value)'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",158.0,0.261785,"SIC-8000 is superior to hetastarch for use during EMR in terms of SRQ and total volume needed, although the absolute differences were small.","[{'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Rex', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Broadley', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Garcia', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Lahr', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'MacPhail', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Connor D', 'Initials': 'CD', 'LastName': 'McWhinney', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Meghan P', 'Initials': 'MP', 'LastName': 'Searight', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Sullivan', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Mahajan', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Eckert', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Krishna C', 'Initials': 'KC', 'LastName': 'Vemulapalli', 'Affiliation': 'Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.06.040'] 273,31637444,Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer.,"BACKGROUND DEPOSEIN (NCT01645839) was a randomized open-label phase III study to explore the role of intrathecal chemotherapy in patients with newly diagnosed leptomeningeal metastasis (LM), a common manifestation of breast cancer. METHODS Patients with newly diagnosed LM defined by tumor cells in the cerebrospinal fluid or combination of clinical and neuroimaging signs of LM were randomized to receive systemic therapy alone (control group) or systemic therapy plus intrathecal liposomal cytarabine (experimental group). Progression-free survival related to LM (LM-PFS) was the primary endpoint. RESULTS Thirty-seven and 36 patients were assigned to the control and the experimental groups. Median number of liposomal cytarabine injections in the experimental group was 5 (range 1-20). Focal radiotherapy was performed in 6 (16%) and 3 (8%) patients in the control and experimental groups. In the intent-to-treat population, median LM-PFS was 2.2 months (95% CI: 1.3-3.1) in the control versus 3.8 months (95% CI: 2.3-6.8) in the experimental group (hazard ratio 0.61, 95% CI: 0.38-0.98) (P = 0.04). Seventy-one patients have died. Median overall survival was 4.0 months (95% CI: 2.2-6.3) in the control versus 7.3 months (95% CI: 3.9-9.6) in the experimental group (hazard ratio 0.85, 95% CI: 0.53-1.36) (P = 0.51). Serious adverse events were reported in 22 and 30 patients, respectively. Quality of life until progression did not differ between groups. CONCLUSION The addition of intrathecal liposomal cytarabine to systemic treatment improves LM-related PFS. Confirmatory trials with optimized patient selection criteria and more active drugs may be required to demonstrate a survival benefit from intrathecal pharmacotherapy.",2020,"Quality of life until progression did not differ between groups. ","['Thirty-seven and 36 patients', 'Patients with newly diagnosed LM defined by tumor cells in the cerebrospinal fluid or combination of clinical and neuroimaging signs of LM', 'newly diagnosed leptomeningeal metastasis from breast cancer', 'patients with newly diagnosed leptomeningeal metastasis (LM']","['intrathecal chemotherapy', 'systemic therapy alone (control group) or systemic therapy plus intrathecal liposomal cytarabine', 'Focal radiotherapy', 'Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone', 'intrathecal liposomal cytarabine']","['died', 'Progression-free survival', 'LM-related PFS', 'Median number of liposomal cytarabine injections', 'median LM-PFS', 'Median overall survival', 'Quality of life until progression', 'Serious adverse events']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C0007807'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4074687', 'cui_str': 'Cytarabine Injection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",71.0,0.23537,"Quality of life until progression did not differ between groups. ","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Le Rhun', 'Affiliation': 'University of Lille, INSERM, Lille, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wallet', 'Affiliation': 'Biostatistics Unit, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Mailliez', 'Affiliation': 'Neuro-oncology, General and Stereotaxic Neurosurgery service, University Hospital of Lille, Lille, France.'}, {'ForeName': 'Marie Cecile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Biostatistics Unit, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rodrigues', 'Affiliation': 'Neuro-oncology, General and Stereotaxic Neurosurgery service, University Hospital of Lille, Lille, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boulanger', 'Affiliation': 'Imaging Department, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Lorgis', 'Affiliation': 'Department of Medical Oncology, Georges François Leclerc Center, Dijon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Barrière', 'Affiliation': 'Department of Medical Oncology, Antoine Lacassagne Center, Nice, France.'}, {'ForeName': 'Yves Marie', 'Initials': 'YM', 'LastName': 'Robin', 'Affiliation': 'Department of Pathology, Oscar Lambret Center, Lille, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology & Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bonneterre', 'Affiliation': 'University of Lille, INSERM, Lille, France.'}]",Neuro-oncology,['10.1093/neuonc/noz201'] 274,31846501,"Implementation of a Cost-Effective Physical Therapy Approach (Coach2Move) to Improve Physical Activity in Community-Dwelling Older Adults With Mobility Problems: Protocol for a Cluster-Randomized, Stepped Wedge Trial.","BACKGROUND Coach2Move is a personalized treatment strategy by physical therapists to elicit physical activity in community-dwelling older adults with mobility problems. OBJECTIVE The primary objective of this study is to assess the effectiveness and cost-effectiveness of the implementation of Coach2Move compared with regular care physical therapy in daily clinical practice. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTION A multicenter cluster-randomized stepped wedge trial is being implemented in 16 physical therapist practices (4 clusters of 4 practices in 4 steps) in the Netherlands. The study aims to include 400 older adults (≥70 years) living independently with mobility problems and/or physically inactive lifestyles. The intervention group receives physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapist care. MEASUREMENTS Measurements are taken at baseline and 3, 6, and 12 months after the start of treatment. The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test). Trial success can be declared if at least 1 parameter improves while another does not deteriorate. Secondary outcomes are level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5 L), and health care expenditures. Multilevel linear regression analyses are used to compare the outcomes between treatment groups according to an intention-to-treat approach. Alongside the trial, a mixed-methods process evaluation is performed to understand the outcomes, evaluate therapist fidelity to the strategy, and detect barriers and facilitators in implementation. LIMITATIONS An important limitation of the study design is the inability to blind treating therapists to study allocation. DISCUSSION The trial provides insight into the effectiveness and cost-effectiveness of the Coach2Move strategy compared with usual care. The process evaluation provides insight into influencing factors related to outcomes and implementation.",2020,The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test).,"['Community-Dwelling Older Adults With Mobility Problems', '16 physical therapy practices (4 clusters of 4 practices in 4 steps) in the Netherlands', 'community-dwelling older adults with mobility problems', '400 older adults (≥70\xa0years), living independently with mobility problems and/or physically inactive lifestyles']","['physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapy care', 'regular care physical therapy', 'Cost-Effective Physical Therapy Approach (Coach2Move']","['effectiveness and cost-effectiveness', 'amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test', 'level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5\xa0L), and healthcare expenditures', 'Physical Activity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0065034', 'cui_str': 'lipid-associated sialic acid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0034380'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",400.0,0.098777,The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test).,"[{'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Heij', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 6500 HB, Nijmegen, the Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, Department of Health Evidence, Section Biostatistics.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Sweerts', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare; Radboud university medical center, Radboud Institute for Health Sciences, Department of Orthopaedics.'}, {'ForeName': 'J Bart', 'Initials': 'JB', 'LastName': 'Staal', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare; and HAN University of Applied Sciences, Research Group Musculoskeletal Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Maria W G', 'Initials': 'MWG', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hoogeboom', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare.'}]",Physical therapy,['10.1093/ptj/pzz183'] 275,32273184,"Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months.","BACKGROUND Availability of affordable inactivated polio vaccines (IPV) is of major importance to meet the increasing global supply needs. The results presented here demonstrate non-inferiority of a reduced-dose, aluminium hydroxide-adjuvanted IPV (IPV-Al) to standard IPV. METHODS A phase 3, observer-blinded, randomised, clinical trial was conducted in Panama in infants who received either IPV-Al (n = 400) or standard IPV (n = 400) at age 2, 4 and 6 months. In the booster trial, subjects received a single dose of IPV-Al at age 15-18 months. The primary endpoint was type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre and a titre ≥8, one month after the primary vaccination series. In the booster trial, the primary endpoint was the type-specific booster effects (geometric mean titre (GMT) post-booster (Day 28)/GMT pre-booster (Day 0). RESULTS Seroconversion rates following primary vaccination with IPV-Al vs IPV were: 96.1% vs 100% (type 1); 100% vs 100% (type 2); and 99.2% vs 100% (type 3) respectively. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the pre-defined -10%-point limit: 3.94% (-6.51; -2.01) for type 1; 0.0% (-1.30; -1.37) for type 2; -0.85 (-2.46; 0.40) for type 3. The booster effects for the group primed with IPV-Al versus the group primed with IPV were 25.3 vs 9.2 (type 1), 19.1 vs 6.5 (type 2) and 50.4 vs 12.5 (type 3). IPV-Al had a comparable safety profile to that of IPV. CONCLUSIONS Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes. A robust booster response was demonstrated following vaccination with IPV-Al, regardless of the primary vaccine received. Both vaccines were well tolerated. ClinicalTrials.gov identifiers: NCT03025750 and NCT03671616. FUNDING Bill & Melinda Gates Foundation.",2020,"Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes.",['Panama in infants who received either IPV-Al (n\xa0=\xa0400) or'],"['IPV', 'aluminium hydroxide-adjuvanted IPV (IPV-Al', 'standard IPV', 'adjuvanted inactivated polio vaccine, IPV-Al']","['type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre', 'Immunogenicity and safety', 'tolerated', 'Seroconversion rates', 'type-specific booster effects (geometric mean titre (GMT']","[{'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.210725,"Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sáez-Llorens', 'Affiliation': 'Hospital del Niño Dr. José Renán Esquivel, Calle 34 Este, Panama City, Panama; Cevaxin, Avenida Mexico Calle 33, Local 4, Calidonia, Panama; National System of Investigation at Senacyt, Panama. Electronic address: xsaezll@cwpanama.net.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Thierry-Carstensen', 'Affiliation': 'Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: BTC@ssi.dk.'}, {'ForeName': 'Lina Saem', 'Initials': 'LS', 'LastName': 'Stoey', 'Affiliation': 'Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: LSST@ssi.dk.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sørensen', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: CHS@ajvaccines.com.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wachmann', 'Affiliation': 'Larix A/S, Lyskær 8b, 2730 Herlev, Denmark. Electronic address: HEW@larixcro.com.'}, {'ForeName': 'Ananda S', 'Initials': 'AS', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA. Electronic address: Ananda.bandyopadhyay@gatesfoundation.org.'}, {'ForeName': 'Pernille Ingemann', 'Initials': 'PI', 'LastName': 'Nielsen', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: PXN@ajvaccines.com.'}, {'ForeName': 'Mie Vestergaard', 'Initials': 'MV', 'LastName': 'Kusk', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: MHK@ajvaccines.com.'}]",Vaccine,['10.1016/j.vaccine.2020.02.066'] 276,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma. METHODS It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months. RESULTS In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months. CONCLUSION The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001'] 277,31700918,"Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial.","Background Neutropenia is a common complication from chemotherapy. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed. This study was to evaluate the efficacy and safety of mecapegfilgrastim for reducing neutropenia compared with filgrastim. Methods This was a randomized, controlled non-inferiority study. A total of 339 breast cancer patients who were eligible for (neo) adjuvant chemotherapy were randomized assigned into three groups to receive mecapegfilgrastim 100 µg/kg, mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day in the first cycle of chemotherapy. The primary endpoint was the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints included the duration of grade ≥3 neutropenia in cycles 2-4, incidence of grade ≥3 neutropenia, and febrile neutropenia (FN). The safety profile was also evaluated. Results The mean duration of grade ≥3 neutropenia was 1.06 [95% confidence interval (CI): 0.65, 1.26] days in mecapegfilgrastim 100 µg/kg group, 1.23 (95% CI: 0.84, 1.88) days in mecapegfilgrastim 6 mg group, and 2.06 (95% CI: 1.66, 2.46) days in the filgrastim group. The mean difference between mecapegfilgrastim 100 µg/kg and filgrastim was -1.00 (95% CI: -1.52, -0.48), the mean difference between mecapegfilgrastim 6 mg and filgrastim was -0.83 (95% CI: -1.36, -0.30). The upper bounds of 95% CI for the difference between mecapegfilgrastim and filgrastim were all <1 day (the predefined non-inferiority margin). For the incidence of grade ≥3 and grade 4 neutropenia, the mean duration of grade 4 neutropenia, mecapegfilgrastim showed better performance compared with filgrastim. For the incidence of FN, there was no difference between patients treated with mecapegfilgrastim and filgrastim. For safety profile, mecapegfilgrastim of two doses groups were all well-tolerated. Fixed 6 mg dose of mecapegfilgrastim exhibited comparable efficacy and safety in comparison with 100 µg/kg during 4 cycles. Conclusions Long-acting mecapegfilgrastim (100 µg/kg and fixed 6 mg) is very effective and well tolerated when administered in the primary prophylaxis of chemotherapy induced neutropenia and in consecutive-cycle treatment. In some clinical parameters, mecafilgrastim is non-inferior and even superior to filgrastim. The fixed 6 mg-dose regimen showed similar efficacy and safety profile compared with 100 µg/kg regimen, and would be the preference in clinical practice, due to the convenient once-per-cycle administration and high-degree treatment compliance for the patients. This study provided new evidence for the novel long-acting rhG-CSF, mecapegfilgrastim, which would be a new alternative for clinical practice for prophylaxis of chemotherapy induced neutropenia.",2019,the mean difference between mecapegfilgrastim 6 mg and filgrastim was -0.83,"['339 breast cancer patients who were eligible for (neo) adjuvant chemotherapy', 'patients with breast cancer']","['Mecapegfilgramtim (code name HHPG-19K', 'mecapegfilgrastim', 'chemotherapy-induced neutropenia', 'mecapegfilgrastim and filgrastim', 'filgrastim', 'mecapegfilgrastim 100 µg/kg, mecapegfilgrastim fixed dose of 6 mg or filgrastim']","['mean duration of grade ≥3 neutropenia', 'duration of grade ≥3 neutropenia in cycles 2-4, incidence of grade ≥3 neutropenia, and febrile neutropenia (FN', 'efficacy and safety', 'duration of grade ≥3 neutropenia', 'neutropenia', 'Efficacy and safety', 'efficacy and safety profile']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C3852763', 'cui_str': 'HHPG-19K'}, {'cui': 'C3179328', 'cui_str': 'mecapegfilgrastim'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy induced neutropenia'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",339.0,0.128093,the mean difference between mecapegfilgrastim 6 mg and filgrastim was -0.83,"[{'ForeName': 'Fengrui', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Xinxiang University, Xinxiang 453100, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Breast Surgery, Chongqing Cancer Hospital, Chongqing 400030, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, Sichuan Province People's Hospital, Chengdu 610072, China.""}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Zhongshan University Cancer Center, Guangzhou 510060, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Breast Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.'}, {'ForeName': 'Zhiyue', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Research and Development, Jiangsu Hengrui Medicine Co., Ltd., Shanghai 200120, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Research and Development, Jiangsu Hengrui Medicine Co., Ltd., Shanghai 200120, China.'}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China.'}]",Annals of translational medicine,['10.21037/atm.2019.07.95'] 278,32234584,Stigma interdependence among pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa.,"BACKGROUND Stigma can exacerbate negative health outcomes in people living with HIV (PLWH). This longitudinal, cluster randomized controlled trial in rural Mpumalanga, South Africa, examined the interdependence of HIV-related stigma among pregnant couples living with HIV, and the potential impact of a lay health worker delivered intervention, Protect Your Family, on changes in stigma over time across couples, controlling for physical intimate partner violence (IPV), verbal IPV, gender, HIV knowledge, and months since HIV diagnosis. Using a form of the Actor-Partner Interdependence model, changes in stigma over time were also examined within each dyad of seroconcordant participants with HIV. METHOD Antenatal clinics were randomized to experimental or control conditions, and participants completed baseline antenatal and 12-month postpartum assessments. Both women and male partners participated in intervention sessions in gender concordant groups and couple or individual sessions. RESULTS Multilevel models (N = 1475) revealed stigma was related to condition and verbal intimate partner violence, but not time. Using an Actor-Partner Interdependence cross-lagged path model to examine within dyad changes in stigma for seroconcordant couples (n = 201), intervention condition participants' stigma levels were not interdependent over time. Women's 12-month stigma was related to their partners' stigma at baseline in the control condition, but not in the intervention condition. DISCUSSION Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners. The intervention may have promoted female empowerment to shape their own beliefs and attitudes towards what it means to be infected with HIV, and express their own agency in responding to how others treat them and they treat themselves.",2020,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","['rural Mpumalanga, South Africa', 'Both women and male partners', 'people living with HIV (PLWH', 'Antenatal clinics', 'pregnant couples living with HIV', 'pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa']",[],"['stigma was related to condition and verbal intimate partner violence', 'Stigma interdependence', 'postpartum stigma']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.0392253,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ramlagan', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Cristofari', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa; Department of Research & Innovation, University of Limpopo, Sovenga, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sifunda', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: djones@med.miami.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112940'] 279,32243994,Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.,"OBJECTIVE To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). DESIGN 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). RESULTS Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). CONCLUSIONS From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. TRIAL REGISTRATION ClinicalTrials.gov number: NCT01535001.",2020,"RESULTS Average costs were similar between groups (6,758 Euros vs. 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156).","['knee osteoarthritis (OA', '100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week', 'patients with knee osteoarthritis', 'patients with moderate-severe knee OA not eligible for TKR']","['individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice', 'written advice']","['Cost-effectiveness', '24-month cost-effectiveness', 'healthcare costs and transfer payments', 'Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'probability of cost-effectiveness', 'Effectiveness']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",100.0,0.0508179,"RESULTS Average costs were similar between groups (6,758 Euros vs. 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156).","[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, 5230, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Region Zealand, Slagelse, 4200, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark. Electronic address: stskou@health.sdu.dk.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, 5230, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laursen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Simonsen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, 9000, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, 9220, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, 9220, Denmark.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ibsen', 'Affiliation': 'I2minds, Aarhus, 8000, Denmark.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Larsen', 'Affiliation': 'VIVE - The Danish Centre of Applied Social Science, Copenhagen, 1150, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kjellberg', 'Affiliation': 'VIVE - The Danish Centre of Applied Social Science, Copenhagen, 1150, Denmark.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.03.009'] 280,31951263,The Sensor Technology and Rehabilitative Timing (START) Protocol: A Randomized Controlled Trial for the Rehabilitation of Mild Traumatic Brain Injury.,"BACKGROUND Clinical practice for rehabilitation after mild traumatic brain injury (mTBI) is variable, and guidance on when to initiate physical therapy is lacking. Wearable sensor technology may aid clinical assessment, performance monitoring, and exercise adherence, potentially improving rehabilitation outcomes during unsupervised home exercise programs. OBJECTIVE The objectives of this study were to: (1) determine whether initiating rehabilitation earlier than typical will improve outcomes after mTBI, and (2) examine whether using wearable sensors during a home-exercise program will improve outcomes in participants with mTBI. DESIGN This was a randomized controlled trial. SETTING This study will take place within an academic hospital setting at Oregon Health & Science University and Veterans Affairs Portland Health Care System, and in the home environment. PARTICIPANTS This study will include 160 individuals with mTBI. INTERVENTION The early intervention group (n = 80) will receive one-on-one physical therapy 8 times over 6 weeks and complete daily home exercises. The standard care group (n = 80) will complete the same intervention after a 6- to 8-week wait period. One-half of each group will receive wearable sensors for therapist monitoring of patient adherence and quality of movements during their home exercise program. MEASUREMENTS The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will include symptomatology, static and dynamic postural control, central sensorimotor integration posturography, and vestibular-ocular-motor function. LIMITATIONS Potential limitations include variable onset of care, a wide range of ages, possible low adherence and/or withdrawal from the study in the standard of care group, and low Dizziness Handicap Inventory scores effecting ceiling for change after rehabilitation. CONCLUSIONS If initiating rehabilitation earlier improves primary and secondary outcomes post-mTBI, this could help shape current clinical care guidelines for rehabilitation. Additionally, using wearable sensors to monitor performance and adherence may improve home exercise outcomes.",2020,The standard care group (n = 80) will complete the same intervention after a 6 to 8-week wait period.,"['160 individuals with mTBI', 'mild traumatic brain injury (mTBI', 'participants with mTBI', 'Mild Traumatic Brain Injury', 'Academic hospital; Oregon Health & Science University, Portland Veterans Affairs Health Care System, and in the home environment']","['receive one-on-one physical therapy 8 times over 6 weeks and complete daily home-exercises', 'Sensor Technology and Rehabilitative Timing (START', 'Protocol']","['Dizziness Handicap Inventory score', ' symptomatology, static and dynamic postural control, central sensorimotor integration posturography, and vestibular-ocular-motor function']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}]",160.0,0.127954,The standard care group (n = 80) will complete the same intervention after a 6 to 8-week wait period.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Parrington', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon; and Veterans Affairs Portland Health Care System, Portland, Oregon.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Jehu', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; Djavad Mowafaghian Centre for Brain Health, Centre for Hip Health and Mobility, and Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fino', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; Veterans Affairs Portland Health Care System; and Department of Health, Kinesiology, and Recreation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stuart', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; and Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Neurology, Oregon Health & Science University.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pettigrew', 'Affiliation': 'Department of Neurology, Oregon Health & Science University.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Murchison', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; and Department of Biostatistics at the University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Gohary', 'Affiliation': 'ADPM Inc, Portland, Oregon.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'VanDerwalker', 'Affiliation': 'ADPM Inc.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': 'ADPM Inc.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hullar', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Oregon Health & Science University.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Chesnutt', 'Affiliation': 'Departments of Family Medicine, Neurology, and Orthopedics & Rehabilitation, Oregon Health & Science University.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Peterka', 'Affiliation': 'National Center for Rehabilitative Auditory Research, Veterans Affairs Portland Health Care System.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; Veterans Affairs Portland Health Care System; and APDM Inc.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'King', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239 (USA); Veterans Affairs Portland Health Care System; and National Center for Rehabilitative Auditory Research, Veterans Affairs Portland Health Care System.'}]",Physical therapy,['10.1093/ptj/pzaa007'] 281,28052413,A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia.,"Iron deficiency anemia (IDA) is common in many chronic diseases, and intravenous (IV) iron offers a rapid and efficient iron correction. This trial compared the efficacy and safety of iron isomaltoside (also known as ferric derisomaltose) and iron sucrose in patients with IDA who were intolerant of, or unresponsive to, oral iron. The trial was an open‐label, comparative, multi‐center trial. Five hundred and eleven patients with IDA from different causes were randomized 2:1 to iron isomaltoside or iron sucrose and followed for 5 weeks. The cumulative dose of iron isomaltoside was based on body weight and hemoglobin (Hb), administered as either a 1000 mg infusion over more than 15 minutes or 500 mg injection over 2 minutes. The cumulative dose of iron sucrose was calculated according to Ganzoni and administered as repeated 200 mg infusions over 30 minutes. The mean cumulative dose of iron isomaltoside was 1640.2 (standard deviation (SD): 357.6) mg and of iron sucrose 1127.9 (SD: 343.3) mg. The primary endpoint was the proportion of patients with a Hb increase ≥2 g/dL from baseline at any time between weeks 1‐5. Both non‐inferiority and superiority were confirmed for the primary endpoint, and a shorter time to Hb increase ≥2 g/dL was observed with iron isomaltoside. For all biochemical efficacy parameters, faster and/or greater improvements were found with iron isomaltoside. Both treatments were well tolerated; 0.6% experienced a serious adverse drug reaction. Iron isomaltoside was more effective than iron sucrose in achieving a rapid improvement in Hb. Furthermore, iron isomaltoside has an advantage over iron sucrose in allowing higher cumulative dosing in fewer administrations. Both treatments were well tolerated in a broad population with IDA.",2017,"Both non-inferiority and superiority were confirmed for the primary endpoint, and a shorter time to Hb increase ≥2 g/dL was observed with iron isomaltoside.","['Five hundred and eleven patients with IDA from different causes', 'patients with iron deficiency anemia', 'patients with IDA who were intolerant of, or unresponsive to, oral iron']","['iron isomaltoside versus iron sucrose', 'iron isomaltoside or iron sucrose', 'iron sucrose', 'iron isomaltoside and iron sucrose']","['cumulative dose of iron sucrose', 'shorter time to Hb increase ≥2 g/dL', 'proportion of patients with a Hb increase ≥2 g/dL', 'mean cumulative dose of iron isomaltoside', 'serious adverse drug reaction', 'efficacy and safety']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0060241', 'cui_str': 'iron saccharate'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0060241', 'cui_str': 'iron saccharate'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",511.0,0.398525,"Both non-inferiority and superiority were confirmed for the primary endpoint, and a shorter time to Hb increase ≥2 g/dL was observed with iron isomaltoside.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennysylvania, USA.'}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Roman', 'Affiliation': 'Lakes Research, Miami Lakes, Florida, USA.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Modiano', 'Affiliation': 'ACRC Arizona Clinical Research, Tucson, Arizona, USA.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Achebe', 'Affiliation': ""Division of Hematology, Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts, USA.""}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical and Non-clinical Research, Pharmacosmos A/S, Holbaek, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Georgetown University School of Medicine, Washington, District of Columbia, USA.'}]",American journal of hematology,['10.1002/ajh.24633'] 282,32307134,A comment on the Sun et al trial 'Postoperative adjuvant IMRT for patients with HCC and portal vein tumor thrombus: An open-label randomized controlled trial'.,,2020,,['patients with HCC and portal vein tumor thrombus'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",[],[],,0.117885,,"[{'ForeName': 'Sri Harsha', 'Initials': 'SH', 'LastName': 'Kombathula', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005, India. Electronic address: drharsha2008@gmail.com.'}, {'ForeName': 'Jeewan Ram', 'Initials': 'JR', 'LastName': 'Vishnoi', 'Affiliation': 'Department of Surgical Oncology, All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Pareek', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005, India.'}, {'ForeName': 'Rakesh Kumar', 'Initials': 'RK', 'LastName': 'Vyas', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005, India.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.03.042'] 283,30886326,Adverse influence of bisoprolol on central blood pressure in the upright position: a double-blind placebo-controlled cross-over study.,"Treatment with beta-blockers is characterized by inferior reduction of central versus peripheral blood pressure. We examined changes in blood pressure, cardiac function, and vascular resistance after 3 weeks of bisoprolol treatment (5 mg/day) during passive head-up tilt in 16 never-treated Caucasian males with grade I-II primary hypertension. A double-blind, randomized, placebo-controlled cross-over design was applied, and hemodynamics were recorded using continuous tonometric pulse wave analysis and whole-body impedance cardiography. Bisoprolol decreased blood pressure in the aorta (~8/10 mmHg, p ≤ 0.032) and radial artery (~10/9 mmHg, p ≤ 0.037), but upright aortic systolic blood pressure was not significantly reduced (p = 0.085). Bisoprolol reduced heart rate and left cardiac work, and increased subendocardial viability index in supine and upright positions (p ≤ 0.044 for all). Bisoprolol increased stroke volume in the supine (~11 ml, p = 0.02) but not in the upright position, while only upright (~1 l/min, p = 0.007) but not supine cardiac output was reduced. Upright elevation in systemic vascular resistance was increased 2.7-fold (p = 0.002), while upright pulse pressure amplification was decreased by ~20% (p = 0.002) after bisoprolol. Aortic augmentation index, augmentation pressure, and pulse pressure were not changed in the supine position but were increased in the upright position (from 9% to 17%, 3-6 mmHg, and 30-34 mmHg, respectively, p ≤ 0.016 for all). In conclusion, although bisoprolol treatment reduced peripheral blood pressure, central systolic blood pressure in the upright position was not decreased. Importantly, the harmful influences of bisoprolol on central pulse pressure and pressure wave reflection were manifested in the upright position.",2020,"Bisoprolol decreased blood pressure in the aorta (~8/10 mmHg, p ≤ 0.032) and radial artery (~10/9 mmHg, p ≤ 0.037), but upright aortic systolic blood pressure was not significantly reduced (p = 0.085).",['16 never-treated Caucasian males with grade I-II primary hypertension'],"['beta-blockers', 'bisoprolol treatment (5\u2009mg/day) during passive head-up tilt', 'bisoprolol', 'placebo']","['blood pressure', 'central pulse pressure and pressure wave reflection', 'central blood pressure', 'supine cardiac output', 'upright aortic systolic blood pressure', 'Bisoprolol increased stroke volume', 'blood pressure, cardiac function, and vascular resistance', 'upright pulse pressure amplification', 'Upright elevation in systemic vascular resistance', 'Aortic augmentation index, augmentation pressure, and pulse pressure', 'radial artery', 'peripheral blood pressure, central systolic blood pressure', 'upright position', 'Bisoprolol reduced heart rate and left cardiac work, and increased subendocardial viability index']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0520872', 'cui_str': 'Increased cardiac stroke volume (finding)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.133562,"Bisoprolol decreased blood pressure in the aorta (~8/10 mmHg, p ≤ 0.032) and radial artery (~10/9 mmHg, p ≤ 0.037), but upright aortic systolic blood pressure was not significantly reduced (p = 0.085).","[{'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Suojanen', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland. lsuojanen@gmail.com.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Haring', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Tikkakoski', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kähönen', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Arttu', 'Initials': 'A', 'LastName': 'Eräranta', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Jukka T', 'Initials': 'JT', 'LastName': 'Mustonen', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}, {'ForeName': 'Ilkka H', 'Initials': 'IH', 'LastName': 'Pörsti', 'Affiliation': 'Faculty of Medicine and Health Technology, P.O. Box 100, FIN-33014 University of Tampere, Tampere, Finland.'}]",Journal of human hypertension,['10.1038/s41371-019-0188-9'] 284,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND We evaluated the association between etiology of maternal anemia and iron status throughout infancy. METHODS Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated. RESULTS Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status. CONCLUSIONS Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5'] 285,31544469,Differential response to targeted acupuncture by gender in patients with gastrointestinal cancer cachexia: secondary analysis of a randomized controlled trial.,"BACKGROUND Cancer cachexia (CC) is a significant contributor to mortality and morbidity in patients with gastrointestinal (GI) cancer. Treatment options to prevent or halt the progression of CC are limited. Targeted acupuncture (TA) was used in GI patients with CC to evaluate for a potential gender effect. PATIENTS AND METHODS Participants ( n  = 30) were recruited from two outpatient clinics in the northern central part of Florida. All participants were diagnosed with CC and GI cancers. A randomized, single-blind, placebo-controlled clinical trial was used to compare TA to non-targeted acupuncture (NTA) over the course of 8 weeks. Primary endpoints were weight and body composition changes measured by bioelectrical impedance analysis (BIA) and biomarker analysis (tumor necrosis factor (TNF)-α and leptin). Herein, gender differences across and within TA and NTA groups were examined as a secondary analysis. RESULTS A significant ( p  = 0.026) interaction between weight and gender was noted, which manifested in a non-significant increase in the male intervention (MI) group, while TNF-α levels significantly increased by gender ( p  = 0.028) and group ( p  = 0.006) over the course of the study. All other groups either lost or did not change weight. The extracellular-to-intracellular water (ECW/ICW) ratio was significantly elevated for the TA group ( p  = 0.02) and for males ( p  = 0.009) at completion of the study. TNF-α and leptin levels were positively correlated within the MI group at the end of the study. CONCLUSION A decrease in leptin in the MI group corresponded to higher appetite and weight gain. The elevated ECW/ICW ratio indicates an inflammatory response in the MI group. This gender-specific response may be based on hormone-specific regulation of food intake. Further studies with larger sample sizes are required to support the results.",2020,The extracellular-to-intracellular water (ECW/ICW) ratio was significantly elevated for the TA group ( p  = 0.02) and for males ( p  = 0.009) at completion of the study.,"['All participants were diagnosed with CC and GI cancers', 'patients with gastrointestinal (GI) cancer', 'Participants ( n \u2009=\u200930) were recruited from two outpatient clinics in the northern central part of Florida', 'patients with gastrointestinal cancer cachexia']","['placebo', 'acupuncture', 'Targeted acupuncture (TA', 'TA to non-targeted acupuncture (NTA']","['leptin', 'weight and body composition changes measured by bioelectrical impedance analysis (BIA) and biomarker analysis (tumor necrosis factor (TNF)-α and leptin', 'appetite and weight gain', 'TNF-α and leptin levels', 'elevated ECW/ICW ratio', 'extracellular-to-intracellular water (ECW/ICW) ratio', 'TNF-α levels']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]",,0.0555334,The extracellular-to-intracellular water (ECW/ICW) ratio was significantly elevated for the TA group ( p  = 0.02) and for males ( p  = 0.009) at completion of the study.,"[{'ForeName': 'Saunjoo L', 'Initials': 'SL', 'LastName': 'Yoon', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grundmann', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Williams', 'Affiliation': 'Sunshine Integrative Health, Gainesville, FL, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Institute on Aging, Department of Aging & Geriatric Research and Department of Anatomy & Cell Biology, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Huo', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'George', 'Affiliation': 'Division of Hematology & Oncology, College of Medicine, University of Florida, Gainesville, FL, USA.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528419873670'] 286,30944054,The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial.,"BACKGROUND Recently, the MONARCA I randomized controlled trial (RCT) was the first to investigate the effect of smartphone-based monitoring in bipolar disorder (BD). Findings suggested that smartphone-based monitoring sustained depressive but reduced manic symptoms. The present RCT investigated the effect of a new smartphone-based system on the severity of depressive and manic symptoms in BD. METHODS Randomized controlled single-blind parallel-group trial. Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs were randomized to the use of a smartphone-based system or to standard treatment for 9 months. Primary outcomes: differences in depressive and manic symptoms between the groups. RESULTS A total of 129 patients with BD (ICD-10) were included. Intention-to-treat analyses showed no statistically significant effect of smartphone-based monitoring on depressive (B = 0.61, 95% CI -0.77 to 2.00, p = 0.38) and manic (B = -0.25, 95% CI -1.1 to 0.59, p = 0.56) symptoms. The intervention group reported higher quality of life and lower perceived stress compared with the control group. In sub-analyses, the intervention group had higher risk of depressive episodes, but lower risk of manic episodes compared with the control group. CONCLUSIONS There was no effect of smartphone-based monitoring. In patient-reported outcomes, patients in the intervention group reported improved quality of life and reduced perceived stress. Patients in the intervention group had higher risk of depressive episodes and reduced risk of manic episodes. Despite the widespread use and excitement of electronic monitoring, few studies have investigated possible effects. Further studies are needed.",2020,The intervention group reported higher quality of life and lower perceived stress compared with the control group.,"['129 patients with BD (ICD-10', 'Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs', 'bipolar disorder', 'bipolar disorder (BD']","['smartphone-based system or to standard treatment', 'smartphone-based monitoring']","['smartphone-based monitoring on depressive', 'higher risk of depressive episodes and reduced risk of manic episodes', 'higher quality of life and lower perceived stress', 'depressive and manic symptoms', 'quality of life and reduced perceived stress', 'risk of manic episodes', 'higher risk of depressive episodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0349208', 'cui_str': 'Manic episode'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",129.0,0.202873,The intervention group reported higher quality of life and lower perceived stress compared with the control group.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Faurholt-Jepsen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'IT University of Copenhagen, Rued Langgaards Vej 7, 2300 Copenhagen, Denmark.'}, {'ForeName': 'Ellen Margrethe', 'Initials': 'EM', 'LastName': 'Christensen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jakob E', 'Initials': 'JE', 'LastName': 'Bardram', 'Affiliation': 'Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars Vedel', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}]",Psychological medicine,['10.1017/S0033291719000710'] 287,30973115,'Tell Your Story': a randomized controlled trial of an online intervention to reduce mental health stigma and increase help-seeking in refugee men with posttraumatic stress.,"BACKGROUND Refugees report elevated rates of posttraumatic stress disorder (PTSD), but are relatively unlikely to seek help for their symptoms. Mental health stigma is a key barrier to help-seeking amongst refugees. We evaluated the efficacy of an online intervention in reducing self-stigma and increasing help-seeking in refugee men. METHODS Participants were 103 refugee men with PTSD symptoms from Arabic, Farsi or Tamil-speaking backgrounds who were randomly assigned to either receive an 11-module online stigma reduction intervention specifically designed for refugees ('Tell Your Story', TYS) or to a wait-list control (WLC) group. Participants completed online assessments of self-stigma for PTSD and help-seeking, and help-seeking intentions and behaviors at baseline, post-intervention, and at a 1 month follow-up. RESULTS Intent-to-treat analyses indicated that, compared to the WLC, TYS resulted in significantly smaller increases in self-stigma for seeking help from post-treatment to follow-up (d = 0.42, p = 0.008). Further, participants in the TYS conditions showed greater help-seeking behavior from new sources at follow-up (B = 0.69, 95% CI 0.19-1.18, p = 0.007) than those in the WLC. The WLC showed significantly greater increases in help-seeking intentions from post-intervention to follow-up (d = 0.27, p = 0.027), relative to the TYS group. CONCLUSIONS This is the first investigation of a mental health stigma reduction program specifically designed for refugees. Findings suggest that evidence-based stigma reduction strategies are beneficial in targeting self-stigma related to help-seeking and increasing help-seeking amongst refugees. These results indicate that online interventions focusing on social contact may be a promising avenue for removing barriers to accessing help for mental health symptoms in traumatized refugees.",2020,Findings suggest that evidence-based stigma reduction strategies are beneficial in targeting self-stigma related to help-seeking and increasing help-seeking amongst refugees.,"['refugee men', 'refugee men with posttraumatic stress', 'Participants were 103 refugee men with PTSD symptoms from Arabic, Farsi or Tamil-speaking backgrounds']","['11-module online stigma reduction intervention specifically designed for refugees', 'online intervention']","['help-seeking intentions', 'self-stigma', 'help-seeking behavior', 'mental health stigma']","[{'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2745478', 'cui_str': 'AM 103'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0337946', 'cui_str': 'Tamils (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",103.0,0.0208517,Findings suggest that evidence-based stigma reduction strategies are beneficial in targeting self-stigma related to help-seeking and increasing help-seeking amongst refugees.,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Nickerson', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Yulisha', 'Initials': 'Y', 'LastName': 'Byrow', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Pajak', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Tadgh', 'Initials': 'T', 'LastName': 'McMahon', 'Affiliation': 'Settlement Services International, Sydney, NSWAustralia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, School of Psychiatry, University of New South Wales, SydneyNSW2052, Australia.'}, {'ForeName': 'Belinda J', 'Initials': 'BJ', 'LastName': 'Liddell', 'Affiliation': 'School of Psychology, University of New South Wales, SydneyNSW2052, Australia.'}]",Psychological medicine,['10.1017/S0033291719000606'] 288,31101538,Clinically Meaningful Change in Sexual Desire in the Psychosexual Daily Questionnaire in Older Men from the TTrials.,"BACKGROUND A recent study of older men participating in the Testosterone Trials (TTrials) defined a clinically meaningful change in the Psychosexual Daily Questionnaire (PDQ) question 4 in hypogonadal men age ≥65 years. This study defines clinically meaningful change in the same population for sexual desire assessed by PDQ question 1. AIM To determine a clinically meaningful change in the answers to question 1 of the PDQ in hypogonadal older men. METHODS Participants in the Sexual Function Trial of the TTrials were randomly divided into a training and test set. Anchor-based methods, including regression analysis, receiver operating characteristic curves, and empirical cumulative distribution functions, were used to determine a clinically meaningful change on question 1 in the training set, and the selected threshold was evaluated in the test set for an effect of testosterone treatment. RESULTS A clinically meaningful increase in question 1 of the PDQ was determined to be ≥0.7 points. CLINICAL IMPLICATIONS Question 1 of the PDQ can be used to assess sexual desire in response to testosterone treatment. STRENGTHS & LIMITATIONS Data were obtained from a single large study of older hypogonadal men. CONCLUSION Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ. Stephens-Shields AJ, Wang C, Preston P, et al. Clinically Meaningful Change in Sexual Desire in the Psychosexual Daily Questionnaire in Older Men from the TTrials. J Sex Med 2019;16:951-953.",2019,Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ.,"['hypogonadal older men', 'older hypogonadal men', 'Participants in the Sexual Function Trial of the TTrials', 'older men participating in the Testosterone Trials (TTrials) defined a clinically meaningful change in the Psychosexual Daily Questionnaire (PDQ) question 4 in hypogonadal men age ≥65 years', 'Older Men from the TTrials']",[],"['Sexual Desire', 'sexual desire']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}]",,0.0448764,Clinically meaningful improvement of sexual desire is a change of ≥0.7 in the score of question 1 of the PDQ.,"[{'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: alisaste@pennmedicine.upenn.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.04.003'] 289,31356274,Simple Versus Complex Preoperative Carbohydrate Drink to Preserve Perioperative Insulin Sensitivity in Laparoscopic Colectomy: A Randomized Controlled Trial.,,2020,"Postoperative insulin sensitivity was maintained, with no differences in hepatic insulin resistance (HOMA2-IR) or fasting blood glucose on POD 1 to 3.","['30 nondiabetic adult patients undergoing', 'Laparoscopic Colectomy']","['simple CHO drink (400\u200amL containing 50 gr of fructose) or a complex CHO drink (400\u200amL containing 40 gr of maltodextrin and 10 gr of fructose', 'preoperative simple CHO drink', 'laparoscopic colon resection', 'Simple Versus Complex Preoperative Carbohydrate Drink', 'preoperative containing complex carbohydrate (CHO']","['postoperative hepatic insulin resistance assessed by Homeostatic model assessment (HOMA2-IR), fasting blood glucose (FBG), and C-reactive protein (CRP) at baseline and postoperative day (POD 1-3), 30-day complications, and hospital length of stay (LOS', 'perioperative insulin sensitivity', 'complications or LOS', 'complex CHO drink [mean (SD', 'hepatic insulin resistance (HOMA2-IR) or fasting blood glucose', 'Intraoperative insulin sensitivity', 'Postoperative insulin sensitivity', 'intraoperative insulin sensitivity assessed by peripheral glucose uptake (M value']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0556154', 'cui_str': 'Complex carbohydrate (substance)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.133548,"Postoperative insulin sensitivity was maintained, with no differences in hepatic insulin resistance (HOMA2-IR) or fasting blood glucose on POD 1 to 3.","[{'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Karimian', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Pepa', 'Initials': 'P', 'LastName': 'Kaneva', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Donatelli', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A Sender', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Feldman', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}]",Annals of surgery,['10.1097/SLA.0000000000003488'] 290,32297874,Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention.,"BACKGROUND Adults who are homeless are more likely to have alcohol use disorders (AUDs) compared with domiciled adults. Although AUD treatments are commonly available, many factors (eg, transportation limitations and inability to schedule appointments) contribute to low treatment completion rates and low success rates of these interventions among adults experiencing homelessness. Most adults who are homeless own mobile phones; however, no interventions have been developed that use mobile devices to deliver and support AUD interventions for this population. Mobile phone-based AUD interventions may reduce barriers that have limited the use and utility of traditional interventions. OBJECTIVE The aim of this study is to (1) identify variables (eg, affect, stress, geolocation, and cravings) that predict drinking among homeless adults (phase I), (2) develop a mobile intervention that utilizes an algorithm to identify moments of risk for drinking and deliver treatment messages that are tailored to the individual's current needs in real time (phase II), and (3) pilot test the intervention app (phase III). METHODS In phase I, adults experiencing homelessness with an AUD (N=80) will complete baseline, equipment, 2-week, and 4-week follow-up visits in person. Participants will be prompted to complete five daily ecological momentary assessments on a study-provided smartphone for 28 days. The smartphone app will collect GPS coordinates every 5 min for the entire 28-day study period. Participants will wear a transdermal alcohol sensor that will objectively measure alcohol use. In phase II, we will use phase I data to develop an algorithm that identifies moments of heightened risk for drinking and develop treatment messages that address risk factors for drinking. Phase III will pilot test the intervention in 40 adults experiencing homelessness with AUD. RESULTS This project was funded in June 2018. IRB approval was obtained in October 2018, and data collection for phase I began in February 2019. Phase III data collection is expected to conclude in 2020. To date, 80 participants have consented to the study, and data analysis for phase I will begin in early 2020. CONCLUSIONS This research will highlight intervention targets and develop a novel intervention for understudied and underserved adults experiencing homelessness with AUD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/15610.",2020,"In phase II, we will use phase I data to develop an algorithm that identifies moments of heightened risk for drinking and develop treatment messages that address risk factors for drinking.","['People Experiencing Homelessness', 'adults experiencing homelessness with an AUD (N=80', '80 participants have consented to the study, and data analysis for phase I will begin in early 2020', 'understudied and underserved adults experiencing homelessness with AUD', 'adults experiencing homelessness', '40 adults experiencing homelessness with AUD', 'Adults who are homeless', 'Most adults who are homeless own mobile phones']","['transdermal alcohol sensor', 'Mobile phone-based AUD interventions']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],40.0,0.044269,"In phase II, we will use phase I data to develop an algorithm that identifies moments of heightened risk for drinking and develop treatment messages that address risk factors for drinking.","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Businelle', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Walters', 'Affiliation': 'School of Public Health, University of North Texas Health Sciences Center, Fort Worth, TX, United States.'}, {'ForeName': 'Eun-Young', 'Initials': 'EY', 'LastName': 'Mun', 'Affiliation': 'School of Public Health, University of North Texas Health Sciences Center, Fort Worth, TX, United States.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kirchner', 'Affiliation': 'School of Global Public Health, New York University, New York City, NY, United States.'}, {'ForeName': 'Emily T', 'Initials': 'ET', 'LastName': 'Hébert', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Xiaoyin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Public Health, University of North Texas Health Sciences Center, Fort Worth, TX, United States.'}]",JMIR research protocols,['10.2196/15610'] 291,32301128,Online HOPE intervention on mental health literacy among youths in Singapore: An RCT protocol.,"AIMS The study aims to examine the effectiveness of the online HOPE intervention to increase mental health literacy (MHL), psychological well-being (PWB); and in reducing stress among youths aged 18-24 living in Singapore. DESIGN The study will be conducted in two phases. The first phase will adopt a single-group pre-post repeated quasi-experimental research design. The second phase adopts a two-group, parallel randomized control trial, with a pre-test, posttest and follow-up. METHODS The study will be conducted in a University in Singapore, in 2019-2021. Participants will be recruited and randomly assigned into one of the two groups. Approval from the institutional review board has been obtained in August 2019. Research funding from National Youth Fund has been obtained in November 2019. Outcome measures will be measured using Depression Literacy Questionnaire, Anxiety literacy Questionnaire, validated depression vignette, Ryff's PWB Scale and Perceived Stress Scale, at baseline, postintervention and 2 months' follow-up. Participants' perceptions of the intervention will be measured qualitatively. DISCUSSION The online HOPE intervention had been developed based on the principles of the Self-Efficacy Theory. IMPACT There is no research about MHL intervention in Singapore. Low MHL prevents early help-seeking and delays treatment. Hence, this study highlights the importance of mental health public education as primary care. Increased MHL will enhance early help-seeking behaviours, promoting early recovery and enhancing the health of the young people worldwide.",2020,"Increased mental health literacy will enhance early help-seeking behaviors, promoting early recovery and enhancing the health of the young people worldwide.","['youths in Singapore', 'University in Singapore, in 2019-2021', 'youths aged 18 - 24 living in Singapore']","['Online HOPE intervention', 'online HOPE intervention']","['mental health literacy', ""Depression Literacy Questionnaire, Anxiety literacy Questionnaire, validated depression vignette, Ryff's psychological well-being Scale and Perceived Stress Scale""]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",2021.0,0.0859902,"Increased mental health literacy will enhance early help-seeking behaviors, promoting early recovery and enhancing the health of the young people worldwide.","[{'ForeName': 'Jing Ling', 'Initials': 'JL', 'LastName': 'Tay', 'Affiliation': 'Institute of Mental Health, Singapore, Singapore.'}, {'ForeName': 'Yong-Shian Shawn', 'Initials': 'YS', 'LastName': 'Goh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yoo Loo Lin School of Medicine, Clinical Research Centre, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Piyanee', 'Initials': 'P', 'LastName': 'Klainin-Yobas', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yoo Loo Lin School of Medicine, Clinical Research Centre, National University of Singapore, Singapore, Singapore.'}]",Journal of advanced nursing,['10.1111/jan.14393'] 292,32282882,"IVMP+IVIG raises platelet counts faster than IVIG alone: results of a randomized, blinded trial in childhood ITP.","Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs). However, there are no controlled data to support using combination therapy over IVIG alone. We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs <20 × 109/L in whom physicians had decided to treat with IVIG. Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2 × 109/L participated. Eighteen were randomized to regimen A and 14 to regimen B. By 8 hours after initiating therapy, 55% of all children had a PC ≥20 × 109/L (no group difference). By 24 hours, mean PCs were 76.9 × 109/L (B) vs 55 × 109/L (A) (P = .06; P = .035 when adjusted for intergroup differences in patient ages). No patient experienced severe bleeding/unexpected severe AEs. There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046). Our findings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP+IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.",2020,There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046).,"['Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2\xa0×', 'children 1-17 years old with primary ITP and PCs <20\xa0×\xa0109/L in whom physicians had decided to treat with IVIG', 'Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage']","['methylprednisolone (IVMP) with IV immune globulin (IVIG', 'IVMP+IVIG', 'placebo']","['platelet counts (PCs', 'rapidity of the PC increment and associated adverse events (AEs', 'IVIG-related headaches', 'severe bleeding/unexpected severe AEs', 'mean PCs']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",32.0,0.385708,There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046).,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Carcao', 'Affiliation': 'Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Kingston General Hospital, Kingston, ON, Canada.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Pediatric Hematology Oncology, CHU Ste-Justine, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Klaassen', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.""}, {'ForeName': 'MacGregor', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': ""Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, IWK Health Centre, Halifax, NS, Canada; and.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wakefield', 'Affiliation': 'Department of Nursing, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Lussia', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Stephens', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Victor S', 'Initials': 'VS', 'LastName': 'Blanchette', 'Affiliation': 'Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada.'}]",Blood advances,['10.1182/bloodadvances.2019001343'] 293,32300797,Psychophysiological Correlates of Emotional- and Alcohol-Related Cues Processing in Offspring of Alcohol-Dependent Patients.,"AIMS To determinate if offspring of alcohol-dependent patients (OA) process affective stimuli and alcohol-related cues in a different manner than control subjects do. METHODS Event-related potentials (early posterior negativity [EPN]/ late positive potential [LPP]) and event-related oscillations (Theta) were obtained by electroencephalographic (EEG) recording during the viewing of International Affective Picture System (IAPS) images with positive, negative and neutral valence, as well as alcohol-related cues. The total sample was comprised of 60 participants, divided into two groups: one group consisted of OA (30) and the control group of participants with negative family history of alcohol use disorders (30). RESULTS Theta power analysis implies a significant interaction between condition, region and group factors. Post-hoc analysis indicates an increased theta power for the OA at different regions, during pleasant (frontal, central, parietal, occipital, right temporal); unpleasant (frontal, central, occipital); alcohol (frontal, central, parietal, occipital, right and left temporal) and neutral (occipital) cues. There are no group differences regarding any of the event-related potential measurements (EPN/LPP). CONCLUSIONS There is evidence of alterations in the processing of affective stimuli and alcohol-related information, evidenced by changes in theta brain oscillations. These alterations are characterized by an increased emotional reactivity, evidenced by increased theta at posterior sites. There is also an increased recruitment of emotion control, which could be a compensation mechanism, evidenced by increased theta power at anterior sites during affective stimuli and alcohol cues.",2020,"Post-hoc analysis indicates an increased theta power for the OA at different regions, during pleasant (frontal, central, parietal, occipital, right temporal); unpleasant (frontal, central, occipital); alcohol (frontal, central, parietal, occipital, right and left temporal) and neutral (occipital) cues.","['30) and the control group of participants with negative family history of alcohol use disorders (30', 'Offspring of Alcohol-Dependent Patients']","['OA', 'Event-related potentials (early posterior negativity [EPN]/ late positive potential [LPP]) and event-related oscillations (Theta) were obtained by electroencephalographic (EEG) recording during the viewing of International Affective Picture System (IAPS) images with positive, negative and neutral valence, as well as alcohol-related cues']",['emotional reactivity'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0476560', 'cui_str': 'Family history of alcohol abuse'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",60.0,0.0407163,"Post-hoc analysis indicates an increased theta power for the OA at different regions, during pleasant (frontal, central, parietal, occipital, right temporal); unpleasant (frontal, central, occipital); alcohol (frontal, central, parietal, occipital, right and left temporal) and neutral (occipital) cues.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Dominguez-Centeno', 'Affiliation': 'Department of Psychiatry, Research Institute 12 de Octubre (i+12), Córdoba Ave. n/n, 28041 Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jurado-Barba', 'Affiliation': 'Department of Psychiatry, Research Institute 12 de Octubre (i+12), Córdoba Ave. n/n, 28041 Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sion', 'Affiliation': 'Department of Psychiatry, Research Institute 12 de Octubre (i+12), Córdoba Ave. n/n, 28041 Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martínez-Maldonado', 'Affiliation': 'Department of Psychiatry, Research Institute 12 de Octubre (i+12), Córdoba Ave. n/n, 28041 Madrid, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Castillo-Parra', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Camilo José Cela University, 49 Castillo de Alarcon St, Villanueva de la Cañada, 28692 Madrid, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'López-Muñoz', 'Affiliation': 'Department of Psychiatry, Research Institute 12 de Octubre (i+12), Córdoba Ave. n/n, 28041 Madrid, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rubio', 'Affiliation': 'Department of Psychiatry, Research Institute 12 de Octubre (i+12), Córdoba Ave. n/n, 28041 Madrid, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Martínez-Gras', 'Affiliation': 'Department of Psychiatry, Research Institute 12 de Octubre (i+12), Córdoba Ave. n/n, 28041 Madrid, Spain.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agaa006'] 294,32253184,"Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study.","OBJECTIVES Bimekizumab selectively neutralises both interleukin (IL)-17A and IL-17F. We report efficacy and safety in a phase IIb dose-ranging study in patients with active ankylosing spondylitis (AS). METHODS Adults with AS (fulfilling modified New York criteria) were randomised 1:1:1:1:1 to bimekizumab 16 mg, 64 mg, 160 mg, 320 mg or placebo every 4 weeks for 12 weeks (double-blind period). At week 12, patients receiving bimekizumab 16 mg, 64 mg or placebo were re-randomised 1:1 to bimekizumab 160 mg or 320 mg every 4 weeks to week 48; other patients continued on their initial dose (dose-blind period). The primary end point was Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 12 (non-responder imputation (NRI) for missing data). RESULTS 303 patients were randomised: bimekizumab 16 mg (n=61), 64 mg (n=61), 160 mg (n=60), 320 mg (n=61) or placebo (n=60). At week 12, significantly more bimekizumab-treated patients achieved ASAS40 vs placebo (NRI: 29.5%-46.7% vs 13.3%; p<0.05 all comparisons; OR vs placebo 2.6-5.5 (95% CI 1.0 to 12.9)). A significant dose-response was observed (p<0.001). The primary end point was supported by all secondary efficacy outcomes. At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients. During the double-blind period, treatment-emergent adverse events occurred in 26/60 (43.3%) patients receiving placebo and 92/243 (37.9%) receiving bimekizumab. CONCLUSIONS Bimekizumab provided rapid and sustained improvements in key outcome measures in patients with active AS, with no unexpected safety findings versus previous studies. TRIAL REGISTRATION NUMBER NCT02963506.",2020,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","['Adults with AS (fulfilling modified New York criteria', 'patients with active AS', '303 patients', 'patients with active ankylosing spondylitis', 'patients with active ankylosing spondylitis (AS']","['bimekizumab', 'placebo', 'interleukin-17A and interleukin-17F with bimekizumab', 'ASAS40 vs placebo', 'bimekizumab 16 mg, 64 mg or placebo', 'Bimekizumab']","['interleukin (IL)-17A and IL-17F', 'adverse events', 'SpondyloArthritis international Society (ASAS) 40 response', 'efficacy and safety', 'ASAS40 response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}]","[{'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",303.0,0.70834,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands mail@dvanderheijde.nl.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Department of Rheumatology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin and Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Mary Katherine', 'Initials': 'MK', 'LastName': 'Farmer', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Baeten', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, UCB Pharma, Slough, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Goldammer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Coarse', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Marga', 'Initials': 'M', 'LastName': 'Oortgiesen', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Université de Paris, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-216980'] 295,32301592,The safety and efficacy of zero-fluoroscopy ablation versus conventional ablation in patients with supraventricular tachycardia.,"BACKGROUND A zero fluoroscopy approach guided by a 3‑dimensional navigation system is an alternative to the traditional conventional fluoroscopy‑navigation approach for ablation of tachycardia. AIMS To compare the safety and efficacy of zero fluoroscopy ablation of supraventricular tachycardia (SVT) guided by the CARTO mapping system (CZF) alone, the EnSite zero fluoroscopy mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method. METHODS From July 2015 to March 2017, patients admitted for SVT ablation were prospectively and consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio. The procedures for the CF group were performed using the traditional fluoroscopy method or the 3‑dimensional mapping method. All data were prospectively recorded by independent researchers. Procedure and fluoroscopic time as well as rate of success, recurrence, and complications in the 3 groups were analyzed. RESULTS One patient from the CZF group was moved to the CF group due to a severe venous malformation during catheter insertion. A total of 100 patients (100%) in the CF group, 100 patients (100%) in the EZF group (100%), and 99 patients (99%) in the CZF group successfully completed the electrophysiology study. There were no severe complications in any of the groups. The mean (SD) procedure time was 61.8 (36.2), 66.5 (24.2), and 65.4 (27.5) minutes in the CF, EZF, and CZF group, respectively. The median (interquartile range) fluoroscopy time of the CF group was 3.6 (2.1-8.8) minutes. CONCLUSIONS The zero fluoroscopy approach guided by the CARTO system is not inferior to the zero fluoroscopy approach guided by the EnSite system or a conventional fluoroscopic approach in terms of the efficiency and safety for ablation of SVT.",2020,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"['patients with supraventricular tachycardia', 'From July 2015 to March 2017, patients admitted for SVT ablation were consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio']","['zero fluoroscopic ablation of supraventricular tachycardia (SVT) guided by the CARTOTM mapping system (CZF) alone, the EnSiteTM zero fluoroscopic mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method', 'CZF', 'CF', 'zero-fluoroscopy ablation versus conventional ablation', 'fluoroscopy radiofrequency catheter ablation']","['median/quartile fluoroscopy time', 'severe complications', 'safety and efficacy', 'severe venous malformation', 'mean (SD) procedure time', 'Procedure and fluoroscopic time, and rate of success, recurrence, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0265950', 'cui_str': 'Venous malformation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0263017,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"[{'ForeName': 'Alselmi', 'Initials': 'A', 'LastName': 'Fadhle', 'Affiliation': ''}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15293'] 296,32299845,"Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial.","OBJECTIVES Riociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression. METHODS In this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52. RESULTS At week 52, change from baseline in mRSS units was -2.09±5.66 (n=57) with riociguat and -0.77±8.24 (n=52) with placebo (difference of least squares means -2.34 (95% CI -4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths. CONCLUSIONS Riociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.",2020,"At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo.","[""adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received"", 'n=57) with riociguat and -0.77±8.24', 'patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression', 'patients with early diffuse cutaneous systemic sclerosis (RISE-SSc']","['riociguat', 'riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo', 'placebo']","['forced vital capacity', ""average Raynaud's condition score"", 'tolerated', 'efficacy and safety', 'change in mRSS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0263008', 'cui_str': 'Fibrosis of the skin'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]","[{'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C3667592', 'cui_str': 'riociguat 0.5 MG'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0034734', 'cui_str': ""Raynaud's disease""}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}]",,0.511816,"At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo.","[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA khannad@med.umich.edu oliver.distler@usz.ch.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Rheumatology A department, Cochin Hospital, APHP, Paris Descartes University, Paris, France.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Division of Medicine, Centre for Rheumatology, University College London, London, UK.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Pope', 'Affiliation': 'Schulich School of Medicine, Division of Rheumatology, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Bečvář', 'Affiliation': 'Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Czirják', 'Affiliation': 'Department of Rheumatology and Immunology, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Department of Internal Medicine and Clinical Immunology, Claude Huriez Hospital, Lille University School of Medicine, Lille, France.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Dermatology, Gunma University Postgraduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Sindhu R', 'Initials': 'SR', 'LastName': 'Johnson', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University Health Network, Mount Sinai Hospital, University of Toronto, Toronto Scleroderma Research Program, Toronto, Ontario, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'De Langhe', 'Affiliation': 'Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Stagnaro', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Riccieri', 'Affiliation': 'Department of Clinical Medicine and Therapy, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Schiopu', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Michigan Medicine University Hospitals, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Division of Rheumatology and Immunology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Smith', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Division of Rheumatology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stevens', 'Affiliation': ""Department of Rheumatology, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Szücs', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Marie-Elise', 'Initials': 'ME', 'LastName': 'Truchetet', 'Affiliation': 'Department of Rheumatology, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wosnitza', 'Affiliation': 'Research & Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Laapas', 'Affiliation': 'StatFinn Oy, Espoo, Finland.'}, {'ForeName': 'Janethe', 'Initials': 'J', 'LastName': 'de Oliveira Pena', 'Affiliation': 'Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Bayer Healthcare, Beijing, China.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kramer', 'Affiliation': 'Research & Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital, Zurich, Switzerland khannad@med.umich.edu oliver.distler@usz.ch.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216823'] 297,32303894,The Physiological Regulation of Emotion During Social Interactions: Vagal Flexibility Moderates the Effects of a Military Parenting Intervention on Father Involvement in a Randomized Trial.,"To make prevention programs more effective and understand ""what works for whom,"" evidence regarding what individual characteristics predict intervention responsiveness is needed. Previous studies have evaluated a military parent training program known as After Deployment Adaptive Parenting Tools/ADAPT, yet less is understood about the program's varying effects for fathers. We tested the physiological regulation of emotion during social interactions as a moderator predicting fathers' responsiveness in a randomized trial of ADAPT, in which emotion regulation was operationally measured through vagal flexibility (VF; dynamic changes in cardiac vagal tone). Families with a child aged between 4 and 13 years for whom physiological data were gathered (n = 145) were randomly assigned to ADAPT (14-week face-to-face group intervention) or a control group (services as usual). Fathers in these families were National Guard/Reserve members who had been deployed to war in Iraq and/or Afghanistan and recently returned. Prior to the intervention, cardiac data was collected in-home throughout a set of family interaction tasks and VF was operationalized as the changes in high frequency (HF) power of heart rate variability (HRV) from a reading task to a problem-solving task. Parenting behaviors were observed and coded based on theory-driven indicators pre-intervention and at 1-year follow-up. Results of structural equation modeling showed that VF significantly moderated fathers' intervention responsiveness, such that fathers with higher vs. lower VF exhibited more effective parenting at 1-year follow-up if they were randomized into ADAPT vs. the control group. This study is the first to demonstrate that parasympathetic vagal functioning may be a biomarker to predict response to a military parenting intervention to enhance parenting in combat deployed fathers. The implications for precision-based prevention are discussed.",2020,"Results of structural equation modeling showed that VF significantly moderated fathers' intervention responsiveness, such that fathers with higher vs. lower VF exhibited more effective parenting at 1-year follow-up if they were randomized into ADAPT vs. the control group.","['Emotion During Social Interactions', 'Families with a child aged between 4 and 13\xa0years for whom physiological data were gathered (n\u2009=\u2009145', 'Fathers in these families were National Guard/Reserve members who had been deployed to war in Iraq and/or Afghanistan and recently returned']","['Military Parenting Intervention', 'military parenting intervention', 'ADAPT (14-week face-to-face group intervention) or a control group (services as usual']","['Parenting behaviors', 'vagal flexibility (VF; dynamic changes in cardiac vagal tone']","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",145.0,0.0230976,"Results of structural equation modeling showed that VF significantly moderated fathers' intervention responsiveness, such that fathers with higher vs. lower VF exhibited more effective parenting at 1-year follow-up if they were randomized into ADAPT vs. the control group.","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'REACH Institute, Department of Psychology, Arizona State University, 900 S. McAllister, Psychology North, Rm 212, Tempe, AZ, 85287, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hoch', 'Affiliation': 'Department of Educational Psychology, University of Minnesota-Twin Cities, 250 Education Sciences Bldg, 56 East River Rd, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Abigail H', 'Initials': 'AH', 'LastName': 'Gewirtz', 'Affiliation': 'Department of Family Social Science and Institute of Child Development, University of Minnesota-Twin Cities, 290 McNeal Hall, 1985 Buford Ave, St. Paul, MN, 55108, USA. agewirtz@umn.edu.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01122-6'] 298,32302682,No Increased Cardiac Mortality or Morbidity of Radiation Therapy in Breast Cancer Patients After Breast-Conserving Surgery: 20-Year Follow-up of the Randomized SweBCGRT Trial.,"PURPOSE Radiation therapy (RT) after breast-conserving surgery reduces locoregional recurrences and improves survival but may cause late side effects. The main purpose of this paper was to investigate long-term side effects after whole breast RT in a randomized clinical trial initiated in 1991 and to report dose-volume data based on individual 3-dimensional treatment plans for organs at risk. METHODS AND MATERIALS The trial included 1187 patients with T1-2 N0 breast cancer randomized to postoperative tangential whole breast RT or no further treatment. The prescription dose to the clinical target volume was 48 to 54 Gy. We present 20-year follow-up on survival, cause of death, morbidity, and later malignancies. For a cohort of patients (n = 157) with accessible computed tomography-based 3-dimensional treatment plans in Dicom-RT format, dose-volume descriptors for organs at risk were derived. In addition, these were compared with dose-volume data for a cohort of patients treated with contemporary RT techniques. RESULTS The cumulative incidence of cardiac mortality was 12.4% in the control group and 13.0% in the RT group (P = .8). There was an increase in stroke mortality: 3.4% in the control group versus 6.7% in the RT group (P = .018). Incidences of contralateral breast cancer and lung cancer were similar between groups. The median D mean (range) heart dose for left-sided treatments was 3.0 Gy (1.1-8.1), and the corresponding value for patients treated in 2017 was 1.5 Gy (0.4-6.0). CONCLUSIONS In this trial, serious late side effects of whole breast RT were limited and less than previously reported in large meta-analyses. We observed no increase in cardiac mortality in irradiated patients. Doses to the heart were a median D mean of 3.0 Gy for left-sided RT. The observed increase in stroke mortality may partly be secondary to cardiac side effects, complications to anticoagulant treatment, or to chance, rather than a direct side effect of tangential whole breast irradiation.",2020,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"['1187 T1-2 N0 breast cancer patients randomised to', 'breast cancer patients after breast conserving surgery', 'organs at risk (OR']","['radiotherapy', 'Radiotherapy (RT', 'postoperative tangential whole breast radiotherapy or no further treatment', 'whole breast radiotherapy']","['stroke mortality', 'cardiac mortality', 'median D mean (range) heart dose', 'cardiac mortality or morbidity', 'loco-regional recurrences and improves survival', 'Incidences of contra lateral breast cancer and lung cancer', 'cumulative incidence of cardiac mortality', 'survival, cause of death, morbidity and later malignancies']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",1187.0,0.0509719,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"[{'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden. Electronic address: fredrika.killander@med.lu.se.'}, {'ForeName': 'Elinore', 'Initials': 'E', 'LastName': 'Wieslander', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Regional Oncologic Centre West, Gothenburg, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lundstedt', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden; Translational Oncology & Urology Research (TOUR), School of Cancer and Pharmaceutical Sciences, Kingś College London, London, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Haghanegi', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellen', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.003'] 299,32302717,Predictors of Change in Left-Ventricular Structure and Function in a Trial of Extended Hours Hemodialysis.,"BACKGROUND Myocardial pathology is common in patients undergoing hemodialysis. To explore the effects of differing aspects of dialysis treatment on its evolution, we examined the impact of change in markers of volume status, hemodynamics and solute clearance on left ventricular (LV) parameters in a randomized trial of extended hours dialysis. METHODS AND RESULTS A Clinical Trial of IntensiVE (ACTIVE) Dialysis randomized 200 patients undergoing hemodialysis to extended dialysis hours (≥ 24 hours/week) or standard hours (12-18 hours/week) for 12 months. In a prespecified substudy, 95 participants underwent cardiac magnetic resonance imaging (CMR) at baseline and at the study's end. Generalized linear regression was used to model the relationship between changes in LV parameters and markers of volume status (normalized ultrafiltration rate and total weekly interdialytic weight gain), hemodynamic changes (systolic and diastolic blood pressure) and solute control (urea clearance, dialysis hours and phosphate). Randomization to extended hours dialysis was not associated with change in any CMR parameter. Reduction in ultrafiltration rate was associated with reduction in LV mass index (P = 0.049) and improved ejection fraction (P = 0.024); reduction in systolic blood pressure was also associated with improvement in ejection fraction (P = 0.045); reduction in interdialytic weight gain was associated with reduced stroke volume (P = 0.038). There were no associations between change in urea clearance, phosphate or total hours per week and CMR parameters. CONCLUSIONS Reduction in ultrafiltration rate and blood pressure are associated with improved myocardial parameters in hemodialysis recipients independently of solute clearance or dialysis time. These findings underscore the importance of fluid status and related parameters as potential treatment targets in this population.",2020,Reduction in UF rate was associated with reduction in LV mass index (LVMI) (P=0.049) and improved ejection fraction (EF) (P=0.024); reduction in systolic BP was also associated with improvement in EF (P=0.045); reduction in IDWG was associated with reduced stroke volume (SV) (P=0.038).,"['200 hemodialysis patients to extended dialysis hours (≥ 24 hours/week) or standard hours (12-18 hours/week) for 12 months', 'hemodialysis recipients', '95 participants underwent', 'hemodialysis patients']","['dialysis treatment', 'cardiac magnetic resonance imaging (CMR']","['ejection fraction (EF', 'myocardial parameters', 'Kt/V, phosphate or total hours per week, and CMR parameters', 'UF rate', 'systolic BP', 'volume status (normalized ultrafiltration [UF] rate and total weekly interdialytic weight gain [IDWG]), hemodynamic changes (systolic and diastolic blood pressure [BP]) and solute control (Kt/V, dialysis hours and phosphate', 'LV mass index (LVMI', 'ultrafiltration rate and blood pressure', 'EF', 'reduced stroke volume (SV']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",200.0,0.0410275,Reduction in UF rate was associated with reduction in LV mass index (LVMI) (P=0.049) and improved ejection fraction (EF) (P=0.024); reduction in systolic BP was also associated with improvement in EF (P=0.045); reduction in IDWG was associated with reduced stroke volume (SV) (P=0.038).,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia; Sydney School of Public Health, University of Sydney, Sydney, Australia; Department of Renal Medicine, St George Hospital, Sydney, Australia. Electronic address: bsmyth@georgeinstitute.org.au.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Grieve', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia; Sydney Translational Imaging Laboratory, Charles Perkins Centre, University of Sydney, Sydney, Australia; Department of Radiology, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Puranik', 'Affiliation': 'Specialist Magnetic Resonance Imaging, Newtown, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': ""Renal Department, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Sunshine Coast University Hospital, Birtinya, Australia; School of Health and Sport Sciences, University of the Sunshine Coast, Australia.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'De Zoysa', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand; Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Scaria', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia; Renal Unit, Concord Repatriation General Hospital, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia; Renal Unit, Concord Repatriation General Hospital, Sydney, Australia.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.03.010'] 300,32303377,"Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial.","BACKGROUND Current treatment of postdural puncture headache includes epidural blood patch (EBP), which is invasive and may result in rare but severe complications. Sphenopalatine ganglion block is suggested as a simple, minimally invasive treatment for postdural puncture headache. We aimed to investigate the analgesic effect of a transnasal sphenopalatine ganglion block with local anaesthetic vs saline. METHODS We conducted a blinded, randomised clinical trial including adults fulfilling the criteria for EBP. Participants received a sphenopalatine ganglion block bilaterally with 1 ml of either local anaesthetic (lidocaine 4% and ropivacaine 0.5%) or placebo (saline). Primary outcome was pain in upright position 30 min post-block, measured on a 0-100 mm VAS. RESULTS We randomised 40 patients with an upright median pain intensity of 74 and 84 mm in the local anaesthetic and placebo groups at baseline, respectively. At 30 min after sphenopalatine ganglion block, the median pain intensity in upright position was 26 mm in the local anaesthetic group vs 37 mm in the placebo group (estimated median difference: 5 mm; 95% confidence interval: -14 to 21; P=0.53). In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76). CONCLUSIONS Administration of a sphenopalatine ganglion block with local anaesthetic had no statistically significant effect on pain intensity after 30 min compared with placebo. However, pain was reduced and EBP was avoided in half the patients of both groups, which suggests a major effect not necessarily attributable to local anaesthetics. CLINICAL TRIAL REGISTRATION NCT03652714.",2020,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76). ","['adults fulfilling the criteria for EBP', '40 patients with an upright median pain intensity of 74 and 84 mm in the local anaesthetic and placebo groups at baseline, respectively', 'postdural puncture headache']","['Sphenopalatine ganglion block', 'placebo', 'transnasal sphenopalatine ganglion block with local anaesthetic vs saline', 'epidural blood patch (EBP', 'sphenopalatine ganglion block bilaterally with 1 ml of either local anaesthetic (lidocaine 4% and ropivacaine 0.5%) or placebo (saline']","['pain in upright position 30 min post-block, measured on a 0-100 mm VAS', 'median pain intensity in upright position', 'pain', 'EBP', 'pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0751188', 'cui_str': 'Post dural puncture headache'}]","[{'cui': 'C0394799', 'cui_str': 'Injection of anesthetic agent into sphenopalatine ganglion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}]",40.0,0.790752,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76). ","[{'ForeName': 'Mads S', 'Initials': 'MS', 'LastName': 'Jespersen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark. Electronic address: mads.seit.jespersen@regionh.dk.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Jaeger', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Ægidius', 'Affiliation': 'Department of Neurology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Fabritius', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duch', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rye', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Afshari', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.025'] 301,31987653,Neurodevelopmental Outcomes of Neonates Randomized to Morphine or Methadone for Treatment of Neonatal Abstinence Syndrome.,"OBJECTIVE To evaluate the effects of pharmacologic treatment of neonatal abstinence syndrome on neurodevelopmental outcome from a randomized, controlled trial. STUDY DESIGN Eight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on methadone or buprenorphine into a randomized trial of morphine vs methadone. Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale. At 18 months, 83 of 99 infants (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development-Third Edition and 77 of 99 (77.7%) with the Child Behavior Checklist (CBCL). RESULTS Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL. However in post hoc analyses, we found differences by atypical NICU Network Neurobehavioral Scale profile on the CBCL. Infants receiving adjunctive phenobarbital had lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems on the CBCL. In adjusted analyses, internalizing and total behavior problems were associated with use of phenobarbital (P = .03; P = .04), maternal psychological distress (measured by the Brief Symptom Inventory) (both P < .01), and infant medical problems (both P = .02). Externalizing problems were associated with maternal psychological distress (P < .01) and continued maternal substance use (P < .01). CONCLUSIONS Infants treated with either morphine or methadone had similar short-term and longer term neurobehavioral outcomes. Neurodevelopmental outcome may be related to the need for phenobarbital, overall health of the infant, and postnatal caregiving environment. TRIAL REGISTRATION ClinicalTrials.gov: NCT01958476.",2020,"RESULTS Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL.","['Eight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on', 'Neonatal Abstinence Syndrome', 'Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale', 'neonatal abstinence syndrome']","['morphine vs methadone', 'morphine or methadone', 'methadone or buprenorphine', 'Morphine or Methadone', 'pharmacologic treatment', 'adjunctive phenobarbital']","['lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems', 'infant medical problems', 'Externalizing problems', 'NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL', 'need for phenobarbital, overall health of the infant, and postnatal caregiving environment', 'Child Behavior Checklist (CBCL', 'continued maternal substance use', 'atypical NICU Network Neurobehavioral Scale profile', 'similar short-term and longer term neurobehavioral outcomes', 'maternal psychological distress', 'internalizing and total behavior problems']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0222045'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",116.0,0.114946,"RESULTS Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL.","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Czynski', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI. Electronic address: ACzynski@wihri.org.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA; Tufts Clinical and Translational Science Institute, Boston, MA; The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Dansereau', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Engelhardt', 'Affiliation': ""Department of Pediatrics, Monroe Carell Jr Children's Hospital at Vanderbilt, Nashville, TN.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marro', 'Affiliation': 'Department of Pediatrics, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'Department of Pediatrics, Jacksonville-University of Florida Health, Jacksonville, FL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Shenberger', 'Affiliation': 'Department of Pediatrics, Baystate Medical Center, Springfield, MA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, MA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Oliveira', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Lester', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI; Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.018'] 302,31594431,Change in Cardiometabolic Risk Factors Associated With Magnitude of Weight Regain 3 Years After a 1-Year Intensive Lifestyle Intervention in Type 2 Diabetes Mellitus: The Look AHEAD Trial.,"Background Weight regain after weight loss is common. The impact on cardiometabolic risk factors is not well established. Methods and Results Publicly available data were analyzed from participants of the Look AHEAD (Action for Health in Diabetes) trial with ≥3% initial weight loss (n=1561) during a 1-year intensive lifestyle intervention and with year 4 follow-up data. Participants who regained (regainers) or maintained (maintainers) weight loss were defined with 5 dichotomized cut points (0%, 25%, 50%, 75%, and 100%) of percentage weight loss regained (weight change from years 1-4 as percentage of first year weight loss). Change in cardiometabolic risk factors after initial weight loss was compared in maintainers and regainers, after controlling for demographics, medications, and baseline and year 1 change in body mass index. The effect was assessed separately in participants with <10% and ≥10% initial weight loss, and women and men. Maintainers exhibited significant improvements to the cardiometabolic risk factors assessed compared with regainers. No weight regain cut point maximized risk difference between maintainers and regainers across risk factors or sex/initial weight loss subgroups. For many risk factors, allowing more regain as part of maintenance (increasing cut point) diminished the cardiometabolic benefit among maintainers. Conclusions Maintaining weight loss was better than regain for all risk factors. No single cut point maximized the risk difference between maintainers and regainers. Maintainers who kept off ≥75% of weight lost had the greatest benefit. These findings emphasize the importance of intervention programs focusing not only on weight loss but weight loss maintenance, given the adverse consequences of the latter. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00017953.",2019,Maintainers exhibited significant improvements to the cardiometabolic risk factors assessed compared with regainers.,"['Participants who regained (regainers) or maintained (maintainers', 'participants with <10% and ≥10% initial weight loss, and women and men', 'Type 2 Diabetes Mellitus']",['Intensive Lifestyle Intervention'],"['cardiometabolic risk factors', 'percentage weight loss regained (weight change', 'weight loss', 'Cardiometabolic Risk Factors']","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0424661', 'cui_str': 'Percentage weight loss (observable entity)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0498345,Maintainers exhibited significant improvements to the cardiometabolic risk factors assessed compared with regainers.,"[{'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Berger', 'Affiliation': 'Friedman School of Nutrition Science and Policy Tufts University Boston MA.'}, {'ForeName': 'Gordon S', 'Initials': 'GS', 'LastName': 'Huggins', 'Affiliation': 'Molecular Cardiology Research Institute Center for Translational Genomics Tufts Medical Center and Tufts University Boston MA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'McCaffery', 'Affiliation': 'Department of Allied Health Sciences University of Connecticut Storrs CT.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Jacques', 'Affiliation': 'Friedman School of Nutrition Science and Policy Tufts University Boston MA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Friedman School of Nutrition Science and Policy Tufts University Boston MA.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.010951'] 303,32297875,"An Internet-Based, Peer-Delivered Messaging Intervention for HIV Testing and Condom Use Among Men Who Have Sex With Men in India (CHALO!): Pilot Randomized Comparative Trial.","BACKGROUND Leveraging internet-based communication tools (eg, messaging apps, SMS text messaging, and email) may be an effective avenue for delivery of HIV prevention messages to men who have sex with men (MSM) in India, but there are limited models for such internet-based interventions. OBJECTIVE The CHALO! pilot was an online educational and behavioral intervention aimed to determine the feasibility, acceptability, and preliminary impact of a peer-delivered, internet-based messaging intervention for HIV testing and consistent condom use for MSM in India. The messages addressed barriers to HIV testing and condom use and were theoretically based on the information-motivation-behavioral skills model. METHODS Between February and March 2015, we recruited, enrolled, and randomized 244 participants via online advertisements on mobile dating apps and Facebook. Eligible men (18 years or older, sexually active with other men, and self-reported HIV-negative or unknown status) were randomized to receive educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance (an undesirable outcome to be avoided) over 12 weeks via internet-based messaging platforms. Participants completed online surveys at baseline and immediately postintervention. RESULTS Participants were similar across arms with respect to sociodemographic and behavioral characteristics. Over 82.0% (200/244) of participants were retained (ie, viewed final messages), and 52.3% (130/244) of them completed the follow-up survey. Of those completing the follow-up survey, 82.3% (107/130) liked or strongly liked participating in CHALO!. The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04). When including those who reported intentions to test, this percentage increased from 44.6% (58/130) at baseline to 65.4% (85/130) at follow-up (P<.01). When examining intentions to test among those without prior HIV testing, intentions increased from 32% (16/50) of the sample at baseline to 56% (28/50) of the sample at follow-up (P=.02). Condom use during anal sex did not significantly change from baseline to follow-up. HIV testing and condom use did not significantly differ between approach and avoidance conditions at follow-up. CONCLUSIONS As one of the first studies of an online HIV prevention intervention for Indian MSM, CHALO! was feasible to implement by a community-based organization, was acceptable to participants, and demonstrated potential to improve HIV testing rates.",2020,"The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04).","['Men', 'Eligible men (18 years or older, sexually active with other men, and self-reported HIV-negative or unknown status', 'Who Have Sex With Men in India', 'Between February and March 2015, we recruited, enrolled, and randomized 244 participants via online advertisements on mobile dating apps and Facebook', 'men who have sex with men (MSM) in India']","['CHALO', 'Peer-Delivered Messaging Intervention for HIV Testing and Condom Use', 'educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance', 'peer-delivered, internet-based messaging intervention for HIV testing and consistent condom use for MSM']",['self-reported HIV testing'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",244.0,0.165018,"The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04).","[{'ForeName': 'Viraj V', 'Initials': 'VV', 'LastName': 'Patel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine, Montefiore Health System, Bronx, NY, United States.'}, {'ForeName': 'Shruta', 'Initials': 'S', 'LastName': 'Rawat', 'Affiliation': 'The Humsafar Trust, Mumbai, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Dange', 'Affiliation': 'The Humsafar Trust, Mumbai, India.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Lelutiu-Weinberger', 'Affiliation': 'François-Xavier Bagnoud Center, School of Nursing, Rutgers Biomedical and Health Sciences, Newark, NJ, United States.'}, {'ForeName': 'Sarit A', 'Initials': 'SA', 'LastName': 'Golub', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, New York, NY, United States.'}]",JMIR public health and surveillance,['10.2196/16494'] 304,31206358,Association of Elevated Plasma Interleukin-18 Level With Increased Mortality in a Clinical Trial of Statin Treatment for Acute Respiratory Distress Syndrome.,"OBJECTIVE A high plasma level of inflammasome mediator interleukin-18 was associated with mortality in observational acute respiratory distress syndrome cohorts. Statin exposure increases both inflammasome activation and lung injury in mouse models. We tested whether randomization to statin therapy correlated with increased interleukin-18 in the ARDS Network Statins for Acutely Injured Lungs from Sepsis trial. DESIGN Retrospective analysis of randomized controlled clinical trial. SETTING Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis. PATIENTS Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population. INTERVENTIONS Random assignment of rosuvastatin or placebo for up to 28 days or 3 days after ICU discharge. MEASUREMENTS AND MAIN RESULTS We measured plasma interleukin-18 levels in all Statins for Acutely Injured Lungs from Sepsis patients with sample available at day 0 (baseline, n = 683) and day 3 (after randomization, n = 588). We tested the association among interleukin-18 level at baseline, rising interleukin-18, and the impact of statin therapy on 60-day mortality, adjusting for severity of illness. Baseline plasma interleukin-18 level greater than or equal to 800 pg/mL was highly associated with 60-day mortality, with a hazard of death of 2.3 (95% CI, 1.7-3.1). Rising plasma interleukin-18 was also associated with increased mortality. For each unit increase in log2 (interleukin-18) at day 3 compared with baseline, the hazard of death increased by 2.3 (95% CI, 1.5-3.5). Subjects randomized to statin were significantly more likely to experience a rise in plasma interleukin-18 levels. Subjects with acute kidney injury, shock, low baseline interleukin-18, and those not receiving systemic corticosteroids were more likely to experience rising interleukin-18. Randomization to statin therapy was associated with rising in interleukin-18 in all of those subsets, however. CONCLUSIONS Elevated baseline plasma interleukin-18 was associated with higher mortality in sepsis-induced acute respiratory distress syndrome. A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.",2019,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"['Acute Respiratory Distress Syndrome', 'Acutely Injured Lungs from Sepsis trial', 'Subjects with acute kidney injury', 'Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis', 'Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population']","['rosuvastatin or placebo', 'statin therapy']","['hazard of death', '60-day mortality', 'Baseline plasma interleukin-18 level', 'plasma interleukin-18 levels', 'mortality']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",683.0,0.63108,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"[{'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trtchounian', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Hunninghake', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Kaimal', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Lori-Ann', 'Initials': 'LA', 'LastName': 'Kozikowski', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'DeSouza', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mogan', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Steingrub', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Joo Heon', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kiichi', 'Initials': 'K', 'LastName': 'Nakahira', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Augustine M', 'Initials': 'AM', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Baron', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}]",Critical care medicine,['10.1097/CCM.0000000000003816'] 305,31521551,Short-term cryotherapy did not substantially reduce pain and had unclear effects on physical function and quality of life in people with knee osteoarthritis: a randomised trial.,"OBJECTIVE Does short-term cryotherapy improve pain, function and quality of life in people with knee osteoarthritis (OA)? DESIGN Randomised controlled trial with concealed allocation, blinded assessment of some outcomes, and intention-to-treat analysis. PARTICIPANTS People living in the community with knee OA. INTERVENTIONS The experimental group received cryotherapy, delivered as packs of crushed ice applied to the knee with mild compression. The control group received the same regimen but with sham packs filled with sand. The interventions were applied once a day for 4 consecutive days. OUTCOME MEASURES Participants were assessed at baseline and on the day after the 4-day intervention period. The primary outcome was pain intensity according to a visual analogue scale. Secondary outcomes were baseline to post-intervention changes according to the Western Ontario and McMaster Universities Osteoarthritis, Knee injury and Osteoarthritis Outcome; Timed Up and Go test; and 30-Second Chair to Stand test. RESULTS Sixty participants were randomised into the experimental group (n = 30) or the control group (n = 30). Twenty-nine participants from each group completed the trial. The mean between-group difference in change in pain severity was -0.8 cm (95% CI -1.6 to 0.1), where negative values favour the experimental group. This result did not reach the nominated smallest worthwhile effect of 1.75 cm. The secondary outcomes had less-precise estimates, with confidence intervals that spanned worthwhile, trivial and mildly harmful effects. CONCLUSION Short-term cryotherapy was not superior to a sham intervention in terms of relieving pain or improving function and quality of life in people with knee OA. Although cryotherapy is considered to be a widely used resource in clinical practice, this study does not suggest that it has an important short-term effect, when compared with a sham control, as a non-pharmacological treatment for people with knee osteoarthritis. REGISTRATION NCT02725047.",2019,Short-term cryotherapy was not superior to a sham intervention in terms of relieving pain or improving function and quality of life in people with knee OA.,"['Twenty-nine participants from each group completed the trial', 'Sixty participants', 'people with knee OA', 'people with knee osteoarthritis (OA', 'people with knee osteoarthritis', 'People living in the community with knee OA']","['Short-term cryotherapy', 'cryotherapy, delivered as packs of crushed ice applied to the knee with mild compression', 'sham packs filled with sand']","['baseline to post-intervention changes according to the Western Ontario and McMaster Universities Osteoarthritis, Knee injury and Osteoarthritis Outcome', 'pain intensity according to a visual analogue scale', 'physical function and quality of life', 'pain', 'less-precise estimates, with confidence intervals that spanned worthwhile, trivial and mildly harmful effects', 'pain, function and quality of life', 'relieving pain or improving function and quality of life', 'pain severity']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",60.0,0.137541,Short-term cryotherapy was not superior to a sham intervention in terms of relieving pain or improving function and quality of life in people with knee OA.,"[{'ForeName': 'Lucas Ogura', 'Initials': 'LO', 'LastName': 'Dantas', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Carolina Carreira', 'Initials': 'CC', 'LastName': 'Breda', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Paula Regina Mendes', 'Initials': 'PRM', 'LastName': 'da Silva Serrao', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Aburquerque-Sendín', 'Affiliation': 'Departamento de Ciencias sociosanitarias, Radiología y Medicina física, Universidad de Córdoba, Spain; Instituto Maimónides de Investigación Biomédica de Córdoba, Spain.'}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Serafim Jorge', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Jonathan Emanuel', 'Initials': 'JE', 'LastName': 'Cunha', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Germanna Medeiros', 'Initials': 'GM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Joao Luiz Quagliotti', 'Initials': 'JLQ', 'LastName': 'Durigan', 'Affiliation': 'Physical Therapy Division, University of Brasilia, Distrito Federal, Brazil.'}, {'ForeName': 'Tania de Fatima', 'Initials': 'TF', 'LastName': 'Salvini', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Brazil. Electronic address: tania@ufscar.br.'}]",Journal of physiotherapy,['10.1016/j.jphys.2019.08.004'] 306,31521553,"Physiotherapist advice to older inpatients about the importance of staying physically active during hospitalisation reduces sedentary time, increases daily steps and preserves mobility: a randomised trial.","QUESTIONS Does advice from a physiotherapist about the importance of staying physically active during hospitalisation improve activity, mobility, strength, length of stay, and complications in older inpatients? What barriers to physical activity during hospitalisation do older inpatients perceive? DESIGN Randomised controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessment. PARTICIPANTS Sixty-eight people who were aged > 60 years and admitted to a university hospital ward. INTERVENTION In addition to usual hospital care, the experimental group received a booklet with content about the deleterious effects of hospitalisation and the importance of staying active during hospitalisation. The control group received usual hospital care only. OUTCOME MEASURES The amount of physical activity was measured via accelerometry during the hospital admission. Mobility was assessed using the de Morton Mobility Index (DEMMI), and muscle strength was assessed using a handgrip dynamometer. Length of stay and complications were extracted from hospital records. The barriers to staying active during hospitalisation were investigated via a questionnaire. RESULTS Accelerometry showed a mean between-group difference of 974 steps/day (95% CI 28 to 1919) in favour of the experimental group. The intervention also increased moderate-intensity physical activity and reduced sedentary time, although these effects might be trivially small. Experimental group participants were about one-fifth as likely to lose mobility during their hospital admission (two of 33) than control group participants (10 of 35), relative risk 0.21 (95% CI 0.05 to 0.90). Effects of the intervention were unclear regarding muscle strength, length of stay and incidence of complications between the groups. Patients reported that the main barriers to remaining active during hospitalisation were dyspnoea, lack of space, and fear of contracting infection. CONCLUSION In older inpatients, the addition of advice from a physiotherapist about maintaining activity during hospitalisation increases the level of physical activity and prevents loss of mobility. REGISTRATION ClinicalTrials.govNCT03297567.",2019,"Effects of the intervention were unclear regarding muscle strength, length of stay and incidence of complications between the groups.","['older inpatients', 'Sixty-eight people who were aged > 60 years and admitted to a university hospital ward']","['usual hospital care only', 'Physiotherapist advice']","['dyspnoea, lack of space, and fear of contracting infection', 'muscle strength, length of stay and incidence of complications', 'Mobility', 'daily steps and preserves mobility', 'physical activity', 'Length of stay and complications', 'moderate-intensity physical activity and reduced sedentary time', 'activity, mobility, strength, length of stay, and complications', 'de Morton Mobility Index (DEMMI), and muscle strength']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",974.0,0.11248,"Effects of the intervention were unclear regarding muscle strength, length of stay and incidence of complications between the groups.","[{'ForeName': 'Nayara Alexia', 'Initials': 'NA', 'LastName': 'Moreno', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno Garcia', 'Initials': 'BG', 'LastName': 'de Aquino', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isabel Fialho', 'Initials': 'IF', 'LastName': 'Garcia', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas Spadoni', 'Initials': 'LS', 'LastName': 'Tavares', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Larissa Francielly', 'Initials': 'LF', 'LastName': 'Costa', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ivens Willians Silva', 'Initials': 'IWS', 'LastName': 'Giacomassi', 'Affiliation': 'Physical Therapy Service, Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil.'}, {'ForeName': 'Adriana Cláudia', 'Initials': 'AC', 'LastName': 'Lunardi', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil; Department of Physical Therapy, School of Medicine, Universidade de São Paulo, São Paulo, Brazil. Electronic address: adriana.lunardi@unicid.edu.br.'}]",Journal of physiotherapy,['10.1016/j.jphys.2019.08.006'] 307,32145279,"Effects of Whole-Body Vibration Training on the Physical Function of the Frail Elderly: An Open, Randomized Controlled Trial.","OBJECTIVE To investigate the feasibility and benefits of whole-body vibration (WBV) exercise as a safe and effective training tool for countering sarcopenia and age-related declines in mobility and function in the frail elderly. DESIGN An open, randomized controlled trial. SETTING Residential care facilities. PARTICIPANTS Male and female volunteers (N=117; 82.5±7.9y). INTERVENTIONS After prescreening for contraindications, participants were randomly allocated to a control, simulated WBV (SIM), or WBV exercise group. All participants received regular care, whereas WBV and SIM participants also underwent thrice-weekly exercise sessions for 16 weeks. Delivered by overload principle, WBV training began with 5 × 1-minute bouts at 6 Hz/2 mm (1:1 min exercise:rest), progressing to 10 × 1 minute at up to 26 Hz/4 mm, maintaining knee flexion. Training for SIM participants mimicked WBV exercise stance and duration only. MAIN OUTCOME MEASURES The timed Up and Go, Parallel Walk, and 10-m Timed Walk (10mTW) tests performance were assessed, in addition to the Barthel Index Questionnaire, at baseline, 8, and 16 weeks of exercise, and 3, 6, and 12 months postexercise. RESULTS High levels of compliance were reported in SIM (89%) and WBV training (93%), with ease of use and no adverse effects. In comparison to baseline levels, WBV training elicited clinically important treatment effects in all parameters compared to SIM and control groups. Treatment effects remained apparent up to 12 months postintervention for Parallel Walk Test and 6 months for 10mTW Test. Functional test performance declined during and postintervention in non-WBV groups. CONCLUSIONS Findings indicate that 16 weeks of low-level WBV exercise provides easily accessible, adequate stimulus for the frail elderly to attain improved levels of physical functionality.",2020,Treatment-effects remained apparent up-to 12-months post-intervention for Parallel Walk and 6-months for 10-m Timed-Walk.,['Residential care-facilities PARTICIPANTS: 117 male and female volunteers (82.5 ± 7.9 years'],"['Control (CON), Simulated-WBV (SIM) or WBV-exercise (WBV) group', 'Whole Body Vibration (WBV) exercise', 'regular care, whilst WBV- and SIM- participants also underwent thrice-weekly exercise sessions']","['WBV-exercise stance', 'Timed-Up-and-Go, Parallel Walk and 10-m Timed-Walk test performance']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",117.0,0.0407411,Treatment-effects remained apparent up-to 12-months post-intervention for Parallel Walk and 6-months for 10-m Timed-Walk.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wadsworth', 'Affiliation': 'School of Sport & Exercise, Massey University, New Zealand; School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Australia. Electronic address: dwadswor@usc.edu.au.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lark', 'Affiliation': 'Sport and Exercise New Zealand, Christchurch, New Zealand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.009'] 308,31355957,Impact of family-centered tailoring of pediatric diabetes self-management resources.,"BACKGROUND The American Diabetes Association recommends a family-centered approach that addresses each family's specific type 1 diabetes self-management barriers. OBJECTIVE To assess an intervention that tailored delivery of self-management resources to families' specific self-management barriers. SUBJECTS At two sites, 214 children 8-16 years old with type 1 diabetes and their parent(s) were randomized to receive tailored self-management resources (intervention, n = 106) or usual care (n = 108). METHODS Our intervention (1) identified families' self-management barriers with a validated survey, (2) tailored self-management resources to identified barriers, and (3) delivered the resources as four group sessions coordinated with diabetes visits. Mixed effects models with repeated measures were fit to A1c as well as parent and child QOL during the intervention and 1 year thereafter. RESULTS Participants were 44% youth (8-12 years) and 56% teens (13-16 years). No intervention effect on A1c or QOL was shown, combining data from sites and age groups. Analyzing results by site and age group, post-intervention A1c for teens at one site declined by 0.06 more per month for intervention teens compared to usual care (P < 0.05). In this group, post-intervention A1c declined significantly when baseline A1c was >8.5 (-0.08, P < 0.05), with an even larger decline when baseline A1c was >10 (-0.19, P < 0.05). In addition, for these teens, the significant improvements in A1c resulted from addressing barriers related to motivation to self-manage. Also at this site, mean QOL increased by 0.61 points per month more during the intervention for parents of intervention youth than for usual care youth (P < 0.05). CONCLUSIONS Tailored self-management resources may improve outcomes among specific populations, suggesting the need to consider families' self-management barriers and patient characteristics before implementing self-management resources.",2019,"Also at this site, mean QOL increased by 0.61 points per month more during the intervention for parents of intervention youth than for usual care youth (P < 0.05). ","['214 children 8-16 years old with type 1 diabetes and their parent(s', 'Participants were 44% youth (8-12 years) and 56% teens (13-16 years']","['tailored self-management resources (intervention, n = 106) or usual care', ""Our intervention (1) identified families' self-management barriers with a validated survey, (2) tailored self-management resources to identified barriers, and (3) delivered the resources as four group sessions coordinated with diabetes visits""]","['mean QOL', 'A1c or QOL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0911524', 'cui_str': 'AM 44'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1521910', 'cui_str': 'Teens'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",214.0,0.0170576,"Also at this site, mean QOL increased by 0.61 points per month more during the intervention for parents of intervention youth than for usual care youth (P < 0.05). ","[{'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Fiallo-Scharer', 'Affiliation': ""Department of Pediatrics, Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee, Wisconsin.""}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Palta', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Betty A', 'Initials': 'BA', 'LastName': 'Chewning', 'Affiliation': 'Sonderegger Research Center, Division of Social and Administrative Sciences in Pharmacy, School of Pharmacy, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Rajamanickam', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wysocki', 'Affiliation': ""Center for Health Care Delivery Science, Nemours Children's Health System, Jacksonville, Florida.""}, {'ForeName': 'Tosha B', 'Initials': 'TB', 'LastName': 'Wetterneck', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}]",Pediatric diabetes,['10.1111/pedi.12899'] 309,32297486,Post-hoc analysis investigating the safety and efficacy of brexpiprazole in Japanese patients with schizophrenia who were switched from other antipsychotics in a long-term study (Secondary Publication).,"A post hoc analysis was performed using data obtained over eight weeks from 200 Japanese patients with schizophrenia who were switched to brexpiprazole monotherapy in a long-term treatment study. The 8-week period comprised of a 4-week switching phase and a 4-week post-switch phase. For the antipsychotic switching schedule, brexpiprazole was first administered at 1 mg/day and increased to 2 mg/day by the end of week 4. Concurrently, the previous antipsychotic(s) was/were tapered gradually from the start of week 3 and discontinued by the end of week 4. Brexpiprazole could then be increased up to 4 mg/day according to the CGI-I criteria. At week 8, 1.8%, 23.2%, 25.0%, and 50% of patients were administered daily brexpiprazole doses of 1, 2, 3, and 4 mg, respectively. The discontinuation rate at week 8 was 17.0%. The major reasons for discontinuation were consent withdrawal (9.5%), occurrence of adverse events (5.5%), and physician's decision (2.0%). Commonly reported adverse events were nasopharyngitis (13.5%), schizophrenia (9.0%), insomnia (6.5%), headache (5.5%), and akathisia (5.5%). The discontinuation rate was 4.9% for patients who were switched from aripiprazole as the primary antipsychotic and 25.4% for those who were switched from other antipsychotics. Owing to the serious adverse events that led to treatment discontinuation, careful switching to brexpiprazole is necessary in patients who previously used olanzapine as their primary antipsychotic.",2020,"Commonly reported adverse events were nasopharyngitis (13.5%), schizophrenia (9.0%), insomnia (6.5%), headache (5.5%), and akathisia (5.5%).","['Japanese patients with schizophrenia who were switched from other antipsychotics in a long-term study (Secondary Publication', '200 Japanese patients with schizophrenia who were switched to']","['brexpiprazole monotherapy', 'brexpiprazole', 'Brexpiprazole', 'aripiprazole', 'olanzapine']","['occurrence of adverse events', 'insomnia', 'headache', 'safety and efficacy', 'akathisia', 'discontinuation rate', 'schizophrenia']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3653897', 'cui_str': 'Other antipsychotics'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",200.0,0.015526,"Commonly reported adverse events were nasopharyngitis (13.5%), schizophrenia (9.0%), insomnia (6.5%), headache (5.5%), and akathisia (5.5%).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': ""Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Usami', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Iwashita', 'Affiliation': 'Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsuo', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12107'] 310,32240909,Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial.,"BACKGROUND Preoperative chemoradiotherapy (CRT) followed by total mesorectal excision is widely accepted as the standard of care for high-risk rectal cancer. Adjuvant chemotherapy is advised in several international guidelines, although the survival benefit remains unclear and compliance is poor. The current multidisciplinary approach has led to major improvements in local control, yet the occurrence of distant metastases has not decreased accordingly. The combination of short-course radiotherapy (SCRT) and chemotherapy in the waiting period before surgery might have several benefits, including higher compliance, downstaging and better effect of systemic therapy. METHODS This is an investigator-initiated, international multicentre randomized phase III trial. High-risk rectal cancer patients were randomized to SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy (25-28 × 2-1.8 Gy) with concomitant capecitabine followed by surgery and optional postoperative chemotherapy (8 cycles CAPOX or 12 cycles FOLFOX4) according to local institutions' policy. The primary endpoint is time to disease-related treatment failure. Here, we report the compliance, toxicity and postoperative complications in both study groups. FINDINGS Between June 2011 and June 2016, 920 patients were enrolled. Of these, 901 were evaluable (460 in the experimental arm and 441 in the standard arm). All patients in the experimental arm received 5 × 5 Gy radiotherapy, and 84% of all patients received at least 75% of the prescribed chemotherapy. In the standard arm, the compliance for CRT was 93% and 58% for postoperative chemotherapy. Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy. No statistically significant differences in surgical procedures or postoperative complications were observed. INTERPRETATION High compliance (84%) of preoperative systemic treatment could be achieved with the experimental approach. Although considerable toxicity was observed during preoperative therapy, this did not lead to differences in surgical procedures or postoperative complications. Longer follow-up time is needed to assess the primary endpoint and related outcomes.",2020,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","['High-risk rectal cancer patients', 'high-risk rectal cancer ', 'Between June 2011 and June 2016, 920 patients were enrolled', '901 were evaluable (460 in the experimental arm and 441 in the standard arm']","['short-course radiotherapy', '5\xa0×\xa05 Gy radiotherapy', 'preoperative chemotherapy and surgery', 'short-course radiotherapy (SCRT) and chemotherapy', 'Adjuvant chemotherapy', 'Preoperative chemoradiotherapy (CRT', 'SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy', 'concomitant capecitabine followed by surgery and optional postoperative chemotherapy']","['Toxicity ≥grade 3', 'time to disease-related treatment failure', 'Compliance and tolerability', 'compliance, toxicity and postoperative complications', 'toxicity', 'surgical procedures or postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",920.0,0.114836,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","[{'ForeName': 'Maxime J M', 'Initials': 'MJM', 'LastName': 'van der Valk', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands. Electronic address: mvandervalk@lumc.nl.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Center, The Netherlands; Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Hilling', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO). Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, Slovenia.'}, {'ForeName': 'Andrès M R', 'Initials': 'AMR', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Derk Jan A', 'Initials': 'DJA', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands. Electronic address: g.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.03.011'] 311,31724334,"Phase III randomized, placebo-controlled, double-blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin-induced peripheral neurotoxicity in stage II/III colorectal cancer.","BACKGROUND Monosialotetrahexosylganglioside (GM1) is a neuroprotective glycosphingolipid that repairs nerves. Oxaliplatin-based chemotherapy is neurotoxic. This study assessed the efficacy of GM1 for preventing oxaliplatin-induced peripheral neurotoxicity (OIPN) in colorectal cancer (CRC) patients receiving oxaliplatin-based chemotherapy. METHODS In total, 196 patients with stage II/III CRC undergoing adjuvant chemotherapy with mFOLFOX6 were randomly assigned to intravenous GM1 or a placebo. The primary endpoint was the rate of grade 2 or worse cumulative neurotoxicity (NCI-CTCAE). The secondary endpoints were chronic cumulative neurotoxicity (EORTC QLQ-CIPN20), time to grade 2 neurotoxicity (NCI-CTCAE or the oxaliplatin-specific neuropathy scale), acute neurotoxicity (analog scale), rates of dose reduction or withdrawal due to OIPN, 3-year disease-free survival (DFS) and adverse events. RESULTS There were no significant differences between the arms in the rate of NCI-CTCAE grade 2 or worse neurotoxicity (GM1: 33.7% vs placebo: 31.6%; P = .76) or neuropathy measured by the EORTC QLQ-CIPN20 or time to grade 2 neurotoxicity using NCI-CTCAE and the oxaliplatin-specific neuropathy scale. GM1 substantially decreased participant-reported acute neurotoxicity (sensitivity to cold items [P < .01], discomfort swallowing cold liquids [P < .01], throat discomfort [P < .01], muscle cramps [P < .01]). The rates of dose reduction or withdrawal were not significantly different between the arms (P = .08). The 3-year DFS rates were 85% and 83% in the GM1 and placebo arms, respectively (P = .19). There were no differences in toxicity between the arms. CONCLUSION Patients receiving GM1 were less troubled by the symptoms of acute neuropathy. However, we do not support the use of GM1 to prevent cumulative neurotoxicity. (ClinicalTrials.gov number, NCT02251977).",2020,"GM1 substantially decreased participant-reported acute neurotoxicity (sensitivity to cold items [P < .01], discomfort swallowing cold liquids [P < .01], throat discomfort [P < .01], muscle cramps [P < .01]).","['196 patients with stage II/III CRC undergoing adjuvant chemotherapy with mFOLFOX6', 'stage II/III colorectal cancer', 'colorectal cancer (CRC) patients receiving']","['monosialotetrahexosylganglioside', 'oxaliplatin-based chemotherapy', 'intravenous GM1', 'GM1', 'placebo', 'Monosialotetrahexosylganglioside (GM1', 'Oxaliplatin-based chemotherapy', 'oxaliplatin']","['throat discomfort', 'cumulative neurotoxicity', 'rate of NCI-CTCAE grade 2 or worse neurotoxicity', 'muscle cramps', 'discomfort swallowing cold liquids', 'rates of dose reduction or withdrawal', '3-year DFS rates', 'chronic cumulative neurotoxicity (EORTC QLQ-CIPN20), time to grade 2 neurotoxicity (NCI-CTCAE or the oxaliplatin-specific neuropathy scale), acute neurotoxicity (analog scale), rates of dose reduction or withdrawal due to OIPN, 3-year disease-free survival (DFS) and adverse events', 'rate of grade 2 or worse cumulative neurotoxicity (NCI-CTCAE', 'acute neurotoxicity', 'toxicity']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1513374', 'cui_str': 'Common terminology criteria for adverse events grade 2 (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",196.0,0.439848,"GM1 substantially decreased participant-reported acute neurotoxicity (sensitivity to cold items [P < .01], discomfort swallowing cold liquids [P < .01], throat discomfort [P < .01], muscle cramps [P < .01]).","[{'ForeName': 'De-Shen', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jie-Wen', 'Initials': 'JW', 'LastName': 'Peng', 'Affiliation': ""Zhongshan People's Hospital, Zhongshan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Foshan City, Foshan, China.""}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Deng', 'Affiliation': 'The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Feng-Hua', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Han-Lin', 'Initials': 'HL', 'LastName': 'Liang', 'Affiliation': ""Zhongshan People's Hospital, Zhongshan, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': ""The First People's Hospital of Foshan City, Foshan, China.""}, {'ForeName': 'Chuan-Bo', 'Initials': 'CB', 'LastName': 'Xie', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Cancer Prevention Research, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Si-Mei', 'Initials': 'SM', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Fan', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhen-Hai', 'Initials': 'ZH', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Pei-Rong', 'Initials': 'PR', 'LastName': 'Ding', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Cancer medicine,['10.1002/cam4.2693'] 312,31769226,Outcomes of a randomized controlled trial assessing a smartphone Application to reduce unmet needs among people diagnosed with CancEr (ACE).,"BACKGROUND Smartphone technology represents an opportunity to deliver practical solutions for people affected by cancer at a scale that was previously unimaginable, such as information, appointment monitoring, and improved access to cancer support services. This study aimed to determine whether a smartphone application (app) reduced the unmet needs among people newly diagnosed with cancer. METHODS A single blind, multisite randomized controlled trial to determine the impact of an app-based, 4-month intervention. Newly diagnosed cancer patients were approached at three health service treatment clinics. RESULTS Eighty-two people were randomized (intervention; n = 43 and control; n = 39), average age was 59.5 years (SD: 12.9); 71% female; 67% married or in a de facto relationship. At baseline, there were no differences in participants' characteristics between the groups. No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4-month) or 12-month follow-up. Overall, 94% used the app in weeks 1-4, which decreased to 41% in weeks 13-16. Mean app use time per participant: Cancer Information, 6.9 (SD: 18.9) minutes; Appointment Schedule, 5.1 (SD: 9.6) minutes; Cancer Services 1.5 minutes (SD: 6.8); Hospital Navigation, 1.4 (SD: 2.8) minutes. CONCLUSIONS Despite consumer involvement in the design of this smartphone technology, the app did not reduce unmet needs. This may have been due to the study being underpowered. To contribute to a meaningful understanding and improved implementation of smartphone technology to support people affected by cancer, practical considerations, such as recruitment issues and access to, and confidence with, apps, need to be considered. Australian New Zealand Clinical Trials Registration (ACTRN) Trial Registration: 12616001251415; WEF 7/9/2016.",2020,"No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4-month) or 12-month follow-up.","['people newly diagnosed with cancer', 'people diagnosed with CancEr (ACE', 'Eighty-two people were randomized (intervention; n\xa0=\xa043 and control; n\xa0=\xa039), average age was 59.5\xa0years (SD: 12.9); 71% female; 67% married or in a de facto relationship', 'Newly diagnosed cancer patients were approached at three health service treatment clinics']","['smartphone application (app', 'smartphone Application']",[],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],82.0,0.292804,"No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4-month) or 12-month follow-up.","[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Livingston', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Heckel', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Orellana', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ashley', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ugalde', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Botti', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Pitson', 'Affiliation': 'Andrew Love Cancer Centre, Barwon Health, University Hospital, Geelong, Vic., Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Woollett', 'Affiliation': 'The University of Melbourne, Medicine, Dentistry and Health Sciences, Melbourne, Vic., Australia.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Chambers', 'Affiliation': 'Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Parente', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Vic., Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chirgwin', 'Affiliation': 'Eastern Health, Department of Oncology, Box Hill, Vic., Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Faculty of Health, School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lavelle', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sutton', 'Affiliation': 'Consumer, Melbourne, Vic., Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Phipps-Nelson', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Krishnasamy', 'Affiliation': 'The University of Melbourne, Medicine, Dentistry and Health Sciences, Melbourne, Vic., Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Simons', 'Affiliation': 'North Eastern Melbourne Integrated Cancer Service, Heidelberg, Vic., Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Heynsbergh', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Nilmini', 'Initials': 'N', 'LastName': 'Wickramasinghe', 'Affiliation': 'Iverson Health Innovation Research Institute, Swinburne University, Hawthorn, Vic., Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'White', 'Affiliation': 'Faculty of Health, School of Psychology, Deakin University, Geelong, Vic., Australia.'}]",Cancer medicine,['10.1002/cam4.2718'] 313,31785451,Assessment of fibula flap with flexor hallucis longus's effect on head & neck tumor patients' quality of life and function of donor site.,"OBJECTIVE Free fibular flaps (FFFs) have been widely used in mandibular reconstruction. It is still unclear whether retaining flexor hallucis longus (FHL) is needed for flaps. This study introduces a comparison in quality of life and donor-site function between those who have and haven't harvested FHL with FFF. METHODS Patients with FFFs were single-blind-randomly assigned into the FHL group or nFHL group. Patients were followed up preoperatively and 1, 3 and 6 months postoperatively via subjective evaluations (SF-36/AOFAS) and objective evaluation s(muscle strength and range of motion). Patients' hospitalization and intraoperative information, donor site morbidity were recorded. RESULTS Each group had 15 patients. The flap harvesting time in FHL group was shorter significantly than nFHL group (125.9 ± 24.8 min vs 146.7 ± 29.9 min, P = 0.048). There were no significant differences in hospitalization information such as operation time, hospitalization days and cost. Donor site morbidities at 1, 3 and 6 months postoperatively showed no significant differences except for the presence of claw toes (nFHL group > FHL group, 40% vs 0, P = 0.017; 53.3% vs 6.7%, P = 0.014; 60.0% vs 13.3%, P = 0.021). There were no significant differences in SF-36 and AOFAS scores. There were no significant differences in muscle strength and range of motion. CONCLUSION Excision of the FHL lowered the flap harvesting time. It did not increase donor site morbidity. The impacts on patients' quality of life and foot function were the same. The surgeons can use the FHL without considering the influence on patients if not retaining the FHL.",2020,"Donor site morbidities at 1, 3 and 6 months postoperatively showed no significant differences except for the presence of claw toes (nFHL group > ","['Patients with FFFs', 'head & neck tumor patients']","['FHL', 'nFHL', 'FHL group or nFHL', ""fibula flap with flexor hallucis longus's"", 'Free fibular flaps (FFFs']","['hospitalization information such as operation time, hospitalization days and cost', 'hospitalization and intraoperative information, donor site morbidity', 'muscle strength and range of motion', 'donor site morbidity', ""patients' quality of life and foot function"", 'Donor site morbidities', 'subjective evaluations (SF-36/AOFAS) and objective evaluation s(muscle strength and range of motion', 'quality of life and donor-site function', 'SF-36 and AOFAS scores', 'quality of life and function of donor site', 'flap harvesting time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016068', 'cui_str': 'Fibula'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0224473', 'cui_str': 'Flexor hallucis longus muscle structure'}, {'cui': 'C0441022', 'cui_str': 'Fibular flap (substance)'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}]",,0.0534717,"Donor site morbidities at 1, 3 and 6 months postoperatively showed no significant differences except for the presence of claw toes (nFHL group > ","[{'ForeName': 'Youkang', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xuedi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation Medicine, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China. Electronic address: zhangzq@sj-hospital.org.""}, {'ForeName': 'Weidi', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department of Rehabilitation Medicine, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China. Electronic address: liangwd@sj-hospital.org.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Rehabilitation Medicine, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Zijia', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Zhongfei', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Weiyi', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Xuexin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China. Electronic address: changfusun@hotmail.com.""}, {'ForeName': 'Fayu', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Oromaxillofacial-Head and Neck Surgery, School of Stomatology, China Medical University, Shenyang, People's Republic of China. Electronic address: lfyhjk@126.com.""}]",Oral oncology,['10.1016/j.oraloncology.2019.104489'] 314,32241795,Two-year cost-effectiveness of different COBRA-like intensive remission induction schemes in early rheumatoid arthritis: a piggyback study on the pragmatic randomised controlled CareRA trial.,"OBJECTIVES To evaluate the cost-effectiveness of treat-to-target strategies among recently diagnosed patients with rheumatoid arthritis (RA) using methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim) compared with (1) this combination with either sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde) in high-risk patients and (2) MTX without GCs (Tight-Step-Up, TSU) in low-risk patients. METHODS The incremental cost-utility was calculated from a healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial. Healthcare costs were collected prospectively through electronic trial records. Quality-adjusted life years (QALYs) were estimated using mapping algorithms for EuroQoL-5 Dimension. Multiple imputation was used to handle missing data and bootstrapping to calculate CIs. Robustness was tested with biological disease-modifying antirheumatic drugs at biosimilar prices. RESULTS In the high-risk group, Classic (∆k€1.464, 95% CI -0.198 to 3.127) and Avant-Garde (∆k€0.636, 95% CI -0.987 to 2.258) were more expensive compared with Slim and QALYs were slightly worse for Classic (∆-0.002, 95% CI -0.086 to 0.082) and Avant-Garde (∆-0.009, 95% CI -0.102 to 0.084). This resulted in the domination of Classic and Avant-Garde by Slim. In the low-risk group, Slim was cheaper (∆k€-0.617, 95% CI -2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated. Results were robust against the price of biosimilars. CONCLUSIONS The combination of MTX with a GC bridging scheme is less expensive with comparable health utility than more intensive step-down combination strategies or a conventional step-up approach 2 years after initial treatment. TRIAL REGISTRATION NUMBER NCT01172639.",2020,"In the low-risk group, Slim was cheaper (∆k€-0.617, 95% CI -2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated.","['low-risk patients', 'diagnosed patients with rheumatoid arthritis (RA', 'healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial', 'early rheumatoid arthritis']","['MTX without GCs (Tight-Step-Up, TSU', 'sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde', 'MTX', 'methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim', 'COBRA-like intensive remission induction schemes']","['cost-effectiveness', 'Healthcare costs', 'price of biosimilars', 'Quality-adjusted life years (QALYs']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0206326', 'cui_str': 'Cobra'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.259848,"In the low-risk group, Slim was cheaper (∆k€-0.617, 95% CI -2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Pazmino', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium sofia.pazmino@kuleuven.be.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Stouten', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'De Cock', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Joly', 'Affiliation': 'Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Van der Elst', 'Affiliation': 'Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Westhovens', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Verschueren', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216874'] 315,31701652,A novel treatment strategy using indocyanine green for transarterial chemoembolization in BCLC stage C hepatocellular carcinoma.,"PURPOSE The aim of our study was to propose a strategy based on indocyanine green (ICG) (SBI) to provide better clinical guidelines for transarterial chemoembolization (TACE) treatments for Barcelona clinic liver cancer (BCLC) stage C hepatocellular carcinoma (HCC) patients. MATERIALS AND METHODS From October 2005 to December 2012, 112 BCLC stage C HCC patients initially treated with TACE were investigated, randomly divided into a training cohort (n = 79) and validation cohort (n = 33). In training group, the patients were grouped based on their 15 minutes ICG retention rate (ICG R15), different chemo drugs and dose of lipidol in TACE. Overall survival (OS) and progression-free survival (PFS) were analyzed in subgroups. Strategy based on ICG was built and verified in validation group. RESULTS For those patients with ICG R15 values >10%, the lipiodol ≤10 mL group showed better survival than the lipiodol >10 mL group. For those patients with ICG R15 values ≤10%, the group that received triple-drug chemotherapy treatments with lipiodol diameter ratio values between 1 and 3 showed better survival than the other group. Patients who conformed with the SBI had better survival times than those who did not conform with the SBI, in both the training cohort (median OS 10.3 vs 5.1 months; P < .001; median PFS, 3.3 vs 2.1 months; P = .006) and the validation cohort (median OS 8.9 vs 7.1 months; P = .087; median PFS, 6.6 vs 2.3 months; P < .001). CONCLUSIONS The SBI is suitable and may provide survival benefits for TACE treatments in BCLC stage C HCC patients.",2020,"Patients who conformed with the SBI had better survival times than those who did not conform with the SBI, in both the training cohort (median OS 10.3 vs 5.1 months; P < .001; median PFS, 3.3 vs 2.1 months; P = .006) and the validation cohort (median OS 8.9 vs 7.1 months; P = .087; median PFS, 6.6 vs 2.3 months; P < .001). ","['From October 2005 to December 2012, 112 BCLC stage C HCC patients initially treated with', 'Barcelona clinic liver cancer (BCLC) stage C hepatocellular carcinoma (HCC) patients', 'BCLC stage C HCC patients', 'BCLC stage C hepatocellular carcinoma']","['lipiodol ≤10', 'transarterial chemoembolization (TACE', 'TACE', 'indocyanine green (ICG) (SBI', 'indocyanine green']","['Overall survival (OS) and progression-free survival (PFS', 'survival times', 'survival']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0441785', 'cui_str': 'Stage C (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0947677', 'cui_str': 'Lipiodol'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0496554,"Patients who conformed with the SBI had better survival times than those who did not conform with the SBI, in both the training cohort (median OS 10.3 vs 5.1 months; P < .001; median PFS, 3.3 vs 2.1 months; P = .006) and the validation cohort (median OS 8.9 vs 7.1 months; P = .087; median PFS, 6.6 vs 2.3 months; P < .001). ","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Department of Hepatobiliary Oncology of the Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.'}, {'ForeName': 'Shao-Hua', 'Initials': 'SH', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Oncology of the Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.'}, {'ForeName': 'Qiao-Xuan', 'Initials': 'QX', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Guangzhou, P.R. China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Zhong', 'Affiliation': 'Department of Burn and Plastic Surgery, 2nd Affiliated Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Liang-He', 'Initials': 'LH', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatobiliary Oncology of the Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kan', 'Affiliation': 'Department of Hepatobiliary Oncology of the Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Hepatobiliary Oncology of the Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.'}, {'ForeName': 'Rong-Ping', 'Initials': 'RP', 'LastName': 'Guo', 'Affiliation': 'Department of Hepatobiliary Oncology of the Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.'}]",Cancer medicine,['10.1002/cam4.2671'] 316,32297782,Influence of menthol and green apple e-liquids containing different nicotine concentrations among youth e-cigarette users.,"E-cigarettes are popular among adolescents. Given that flavors enhance e-cigarette appeal, this study examined the influence of flavors on nicotine in e-cigarettes. Youth e-cigarette users (average 26.2 days [SD = 3.6] in past 28 days) were randomized to use e-cigarettes containing 6 or 12 mg/mL of freebase nicotine and completed 4 test sessions. During the first 3 test sessions, participants completed 3 fixed puffing bouts (1 puffing bout = 10 puffs, 3 s each, 30-s interval), using menthol, green-apple, and unflavored e-liquids (50 propylene glycol [PG]/50 vegetable glycerin [VG]) with their assigned nicotine concentration in a random order using a ∼5.5-W V2 e-cigarette device. After each puffing bout, participants assessed subjective effects of nicotine and flavor. In the 4th test session, participants used any of the e-liquids they had tried in the earlier sessions, ad libitum for 60 min and the amount of e-liquid used for each flavor and the number of puffs was assessed. Participants (n = 49; 6 mg/mL [n = 24]; 12 mg/mL [n = 25]) were 63.3% male, 65.3% non-Hispanic White with an average age of 18.7 (SD = 0.9). Mixed models analysis revealed that green apple and 6 mg/mL of nicotine independently increased liking of e-cigarette taste. In addition, green apple produced higher ratings of fruitiness, sourness, sweetness, and menthol produced higher ratings of coolness. We did not observe any interactions between nicotine and flavor. Youth liked the taste of e-liquids containing green-apple flavor or low nicotine concentration which highlights the appeal of fruit flavors in e-cigarettes to adolescents. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Mixed models analysis revealed that green apple and 6 mg/mL of nicotine independently increased liking of e-cigarette taste.,"['Youth e-cigarette users (average 26.2 days [SD = 3.6] in past 28 days', 'n = 25]) were 63.3% male, 65.3% non-Hispanic White with an average age of 18.7 (SD = 0.9', 'youth e-cigarette users']","['e-cigarettes containing 6 or 12 mg/mL of freebase nicotine', 'nicotine', 'menthol, green-apple, and unflavored e-liquids (50 propylene glycol [PG]/50 vegetable glycerin [VG]) with their assigned nicotine concentration', 'menthol and green apple e-liquids']",['liking of e-cigarette taste'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}]",,0.0546791,Mixed models analysis revealed that green apple and 6 mg/mL of nicotine independently increased liking of e-cigarette taste.,"[{'ForeName': 'Asti', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Green', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'Hanno C', 'Initials': 'HC', 'LastName': 'Erythropel', 'Affiliation': 'Department of Chemical and Environmental Engineering.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Eid', 'Affiliation': 'Department of Laboratory Medicine.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000368'] 317,31667606,Programmed intermittent epidural bolus decreases the incidence of intra-partum fever for labor analgesia in primiparous women: a randomized controlled study.,"PURPOSE To evaluate whether programmed intermittent epidural bolus (PIEB) reduces the incidence of maternal intra-partum fever compared with continuous epidural infusion (CEI) during labor. METHODS Parturients were randomized to receive CEI (CEI group) or PIEB (PIEB group) with 10 ml per hour for epidural labor analgesia with 1500 subjects in each group. The maintaining dose of two groups is 0.08% ropivacaine with 0.4 μg/ml sufentanil, with patient-controlled epidural analgesia (PCEA) dose of 5 ml and lockout interval of 30 min. The incidence of maternal fever, pain score, epidural sensory levels, the number and proportion of PCEA demand, anesthetics consumption, satisfaction score, neonatal Apgar scale, and maternal and neonatal side effects were recorded. RESULTS It was significantly lower of the incidence of maternal fever beginning at 4 h post-analgesia and continuing until delivery in the PIEB group than the CEI group (4 h: 2.6% vs. 4.2%; 5 h: 7.3% vs. 10.2%; delivery: 5.6% vs. 7.9%; 1 h post-delivery: 3.9% vs. 6.2%; 2 h post-delivery: 2.1 vs. 3.5%; total: 5.8% vs. 8.4% in PIEB and CEI, respectively). Compared with CEI group, pain scores at 3, 4, 5 h post-analgesia and delivery (3 h: 2 [1, 2] vs. 2 [1-3]; 4 h: 2 [2, 3] vs. 3 [2-4]; 5 h: 2 [2, 3] vs. 3 [2-4]; delivery: 3 [2-4] vs. 4 [3, 4] in PIEB and CEI, respectively), the number and proportion of PCEA demand (number: 0.7 ± 0.9 vs. 2.2 ± 1.9; proportion: 42.0% vs. 80.3% in PIEB and CEI, respectively), and anesthetics consumption significantly decreased in the PIEB group (Ropivacaine: 60 ± 13 mg vs. 76 ± 17 mg; Sufentanil: 26 ± 4 mg vs. 32 ± 6 mg in PIEB and CEI, respectively), without severe maternal and neonatal side effects and any difference in neonatal Apgar scale. The epidural sensory levels 2 h post-analgesia (2 h: 8[8, 9] vs. 9[8, 9] in PIEB and CEI) and satisfaction score (9 [9, 10] vs. 7 [6, 7] in PIEB and CEI) were significantly higher in the PIEB group compared with those in the CEI group. CONCLUSIONS PIEB with 10 ml of 0.08% ropivacaine and 0.4 μg/ml sufentanil hourly provided a lower incidence of intra-partum fever with a better analgesic effect compared with CEI, without any severe maternal and neonatal adverse reactions.",2019,"0.4 μg/ml sufentanil hourly provided a lower incidence of intra-partum fever with a better analgesic effect compared with CEI, without any severe maternal and neonatal adverse reactions.","['Parturients', 'primiparous women']","['CEI', 'ropivacaine', 'Ropivacaine', 'CEI (CEI group) or PIEB (PIEB group) with 10\xa0ml per hour for epidural labor analgesia', 'sufentanil', 'Sufentanil', 'ropivacaine with 0.4\xa0μg/ml sufentanil', 'programmed intermittent epidural bolus (PIEB']","['severe maternal and neonatal adverse reactions', 'pain scores', 'anesthetics consumption', 'neonatal Apgar scale', 'incidence of maternal fever, pain score, epidural sensory levels, the number and proportion of PCEA demand, anesthetics consumption, satisfaction score, neonatal Apgar scale, and maternal and neonatal side effects', 'incidence of maternal intra-partum fever', 'number and proportion of PCEA demand', 'PIEB and CEI', 'PIEB and CEI) and satisfaction score', 'incidence of intra-partum fever', 'maternal fever']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0222045'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",1500.0,0.232542,"0.4 μg/ml sufentanil hourly provided a lower incidence of intra-partum fever with a better analgesic effect compared with CEI, without any severe maternal and neonatal adverse reactions.","[{'ForeName': 'Yuru', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Labor and Delivery Room, Nanjing Maternity and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Hou', 'Affiliation': ""Department of Obstetrics, Nanjing Maternity and Child Health Care Hospital, Women' s Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Clinical Medicine, Kangda College of Nanjing Medical University, Lianyungang, China.'}, {'ForeName': 'Pengyuan', 'Initials': 'P', 'LastName': 'Mao', 'Affiliation': ""Department of Human Resources, Nanjing Maternity and Child Health Care Hospital, Women' s Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Nanjing Maternity and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, 123 Tianfei Lane, Nanjing, 210004, China.""}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Operating Room, Nanjing Maternity and Child Health Care Hospital, Women' s Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Anesthesiology, Nanjing Maternity and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, 123 Tianfei Lane, Nanjing, 210004, China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ""Department of Anesthesiology, Nanjing Maternity and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, 123 Tianfei Lane, Nanjing, 210004, China.""}, {'ForeName': 'Shanwu', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of Anesthesiology, Nanjing Maternity and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, 123 Tianfei Lane, Nanjing, 210004, China. shanwufeng@163.com.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Gynecology, Nanjing Maternity and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, 123 Tianfei Lane, Nanjing, 210004, China. lipingnjmchch@163.com.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05354-y'] 318,31162128,The Telemedicine for Patients With Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants' Perceptions.,"BACKGROUND Inflammatory bowel disease (IBD), comprising Crohn disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of this study, telemedicine for patients with IBD (TELE-IBD), was to compare disease activity and quality of life (QoL) in a 1-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL, but there were no significant differences between groups. Study adherence to the text-based intervention was less than 80%, the targeted goal. OBJECTIVE To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants' perceptions, including their recommendations for future monitoring. METHODS In this study, patients attending 3 tertiary referral centers with worsening IBD symptoms in the previous 2 years were eligible for randomization to remote monitoring via SMS text messages (short message service, SMS) every other week, weekly, or standard care. Participants (n=348) were evenly enrolled in the treatment groups, and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and nonadherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% (278/348) or more of the weekly or every other week self-assessments. Semistructured interviews conducted by phone surveyed (1) the strengths and benefits of TELE-IBD, (2) challenges associated with using TELE-IBD, and (3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti, version.7 qualitative data analysis software. RESULTS Participants' discussions centered on 3 elements of the intervention: (1) self-assessment questions, (2) action plans, and (3) educational messages. Participants also commented on text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and nonadherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive the intervention as effective in facilitating IBD self-management. CONCLUSIONS Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD.",2019,"Treatment groups experienced improvements in disease activity and QoL, but there were no significant differences between groups.","['patients attending 3 tertiary referral centers with worsening IBD symptoms in the previous 2 years were eligible for randomization to remote monitoring via SMS text messages (short message service, SMS', 'IBD patients receiving', 'Patients With Inflammatory Bowel Disease (TELE-IBD', ""Participants' Perceptions"", 'Participants (n=348) were evenly enrolled in the treatment groups, and 259 (74.4%) completed the study', 'purposive sample of adherent (N=15) and nonadherent (N=14) patients was drawn from the TELE-IBD trial population', 'patients with IBD (TELE-IBD']","['Telemedicine', 'telemedicine', 'telemedicine versus standard care']","['Adherence', 'disease activity and QoL', 'disease activity and quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3178909'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}]",348.0,0.0415353,"Treatment groups experienced improvements in disease activity and QoL, but there were no significant differences between groups.","[{'ForeName': 'Charlene Connolly', 'Initials': 'CC', 'LastName': 'Quinn', 'Affiliation': 'University of Maryland School of Medicine, Department of Epidemiology and Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Chard', 'Affiliation': 'University of Maryland Baltimore County, Department of Sociology, Anthropology, and Health Administration and Policy, Baltimore, MD, United States.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Roth', 'Affiliation': 'University of Maryland Baltimore County, Department of Sociology, Anthropology, and Health Administration and Policy, Baltimore, MD, United States.'}, {'ForeName': 'J Kevin', 'Initials': 'JK', 'LastName': 'Eckert', 'Affiliation': 'University of Maryland Baltimore County, Department of Sociology, Anthropology, and Health Administration and Policy, Baltimore, MD, United States.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Russman', 'Affiliation': 'University of Maryland School of Medicine, Department of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Raymond K', 'Initials': 'RK', 'LastName': 'Cross', 'Affiliation': 'University of Maryland School of Medicine, Department of Medicine, Baltimore, MD, United States.'}]",Journal of medical Internet research,['10.2196/14165'] 319,32161055,Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis.,"OBJECTIVES To evaluate initial combination therapy with ambrisentan plus tadalafil (COMB) compared with monotherapy of either agent (MONO), and the utility of baseline characteristics and risk stratification in predicting outcomes, in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation. METHODS This post hoc analysis of the Ambrisentan and Tadalafil in Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population. Time to clinical failure (TtCF) was assessed by baseline characteristics, treatment assignment and risk group (low, intermediate and high) at baseline and week 16. TtCF was compared between groups using Kaplan-Meier curves and Cox proportional hazards regression modelling. RESULTS The analysis included 216 patients (COMB, n=117; MONO, n=99). The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline. The risk of clinical failure was lower with COMB versus MONO in the baseline low-risk group (HR not calculated due to no events in COMB), baseline intermediate-risk group (HR 0.519, 95% CI 0.297 to 0.905) and in the week 16 low-risk group (HR 0.069, 95% CI 0.009 to 0.548). CONCLUSIONS The benefit of COMB over MONO was demonstrated in patients with CTD-PAH, particularly in those with typical PAH haemodynamic characteristics at baseline. COMB is appropriate for patients categorised as low risk and intermediate risk at baseline and low risk at follow-up. TRIAL REGISTRATION NUMBER NCT01178073.",2020,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","['Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population', 'connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH', '216 patients (COMB, n=117; MONO, n=99', 'patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation']","['ambrisentan plus tadalafil (COMB', 'monotherapy of either agent (MONO', 'ambrisentan and tadalafil', 'TtCF', 'Ambrisentan and Tadalafil']","['risk of clinical failure', 'Time to clinical failure (TtCF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009782', 'cui_str': 'Connective Tissue Diseases'}, {'cui': 'C1701938', 'cui_str': 'Associated pulmonary arterial hypertension (disorder)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0854255', 'cui_str': 'Systemic sclerosis pulmonary'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",216.0,0.134752,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan kuwanam@nms.ac.jp.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Research and Development, Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Tokyo, Japan.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Brentford, London, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Coghlan', 'Affiliation': 'Cardiology Services, Royal Free Hospital, London, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216274'] 320,31714037,Development and pilot evaluation of a personalized decision support intervention for low risk prostate cancer patients.,"OBJECTIVES Development and pilot evaluation of a personalized decision support intervention to help men with early-stage prostate cancer choose among active surveillance, surgery, and radiation. METHODS We developed a decision aid featuring long-term survival and side effects data, based on focus group input and stakeholder endorsement. We trained premedical students to administer the intervention to newly diagnosed men with low-risk prostate cancer seen at the University of California, San Francisco. Before the intervention, and after the consultation with a urologist, we administered the Decision Quality Instrument for Prostate Cancer (DQI-PC). We hypothesized increases in two knowledge items from the DQI-PC: How many men diagnosed with early-stage prostate cancer will eventually die of prostate cancer? How much would waiting 3 months to make a treatment decision affect chances of survival? Correct answers were: ""Most will die of something else"" and ""A little or not at all."" RESULTS The development phase involved 6 patients, 1 family member, 2 physicians, and 5 other health care providers. In our pilot test, 57 men consented, and 44 received the decision support intervention and completed knowledge surveys at both timepoints. Regarding the two knowledge items of interest, before the intervention, 35/56 (63%) answered both correctly, compared to 36/44 (82%) after the medical consultation (P = .04 by chi-square test). CONCLUSIONS The intervention was associated with increased patient knowledge. Data from this pilot have guided the development of a larger scale randomized clinical trial to improve decision quality in men with prostate cancer being treated in community settings.",2020,"Regarding the two knowledge items of interest, before the intervention, 35/56 (63%) answered both correctly, compared to 36/44 (82%) after the medical consultation (P = ","['newly diagnosed men with low-risk prostate cancer seen at the University of California, San Francisco', '57 men consented, and 44 received the', 'low risk prostate cancer patients', '6 patients, 1 family member, 2 physicians, and 5 other health care providers', 'men with early-stage prostate cancer', 'men with prostate cancer being treated in community settings']","['decision support intervention', 'personalized decision support intervention']","['patient knowledge', 'Decision Quality Instrument for Prostate Cancer']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",57.0,0.07456,"Regarding the two knowledge items of interest, before the intervention, 35/56 (63%) answered both correctly, compared to 36/44 (82%) after the medical consultation (P = ","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Belkora', 'Affiliation': 'Institute for Health Policy Studies, University of California, San Francisco, CA, USA.'}, {'ForeName': 'June M', 'Initials': 'JM', 'LastName': 'Chan', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Stupar', 'Affiliation': 'Institute for Health Policy Studies, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Tia', 'Initials': 'T', 'LastName': 'Weinberg', 'Affiliation': 'Institute for Health Policy Studies, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Broering', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Tenggara', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Cowan', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Kenfield', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeffry P', 'Initials': 'JP', 'LastName': 'Simko', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Witte', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Carroll', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}]",Cancer medicine,['10.1002/cam4.2685'] 321,32197408,"Quality of Life: Psychological Symptoms-Effects of a 2-Month Healthy Diet and Nutraceutical Intervention; A Randomized, Open-Label Intervention Trial (RISTOMED).","Depression symptoms and lower health-related quality of life (HRQoL) are associated with inflammation. This multicenter dietary intervention was shown to reduce inflammation in older people. This was the main outcome. Here, we describe the effects on HRQoL, anxiety, and depressive symptoms according to inflammation status. Overall, 125 healthy older subjects (65-80 year) were recruited (Italy, France, and Germany) and randomized into four arms (A, Healthy diet (HD); B, HD plus De Simone Formulation probiotic blend; C, HD plus AISA d-Limonene; D, HD plus Argan oil). The HD was weight maintaining, rich in antioxidant vitamins, polyphenols, polyunsaturated fatty acids (n6: n3 ratio = 3:1), and fiber. Data on inflammatory parameters, mental (MCS) and physical (PCS) component summaries of HRQoL (SF-36), anxiety symptoms (STAI state), and depressive symptoms (CES-D) were collected before and after 56 days of intervention. Body fat mass proportion (BFM) was considered a co-variable. A decrease of CES-D score was seen in the four arms (A: -40.0%, p = 0.001; B: -32.5%, p = 0.023; C: -42.8%, p = 0.004; and D: -33.3%, p = 0.21). Within the subgroups of subjects with medium/high inflammation a similar decrease in CES-D score occurred in all groups (A: -44.8%, p = 0.021; B, -46.7%, p = 0.024; C, -52.2%, p = 0.039; D, -43.8%, p = 0.037). The effect of interventions on CES-D was not related to baseline inflammation. MCS-HRQoL improved in A and C. There was no change in anxiety or PCS-HRQoL. In this trial with no control group, a decrease in depressive symptoms in healthy older volunteers was observed after a 2-month healthy diet intervention, independently of inflammation but with possible limitations due to participation.",2020,"A decrease of CES-D score was seen in the four arms (A: -40.0%, p = 0.001; B: -32.5%, p = 0.023; C: -42.8%, p = 0.004; and D: -33.3%, p = 0.21).","['healthy older volunteers', 'older people', '125 healthy older subjects (65-80 year) were recruited (Italy, France, and Germany']","['2-Month Healthy Diet and Nutraceutical Intervention', 'Healthy diet (HD); B, HD plus De Simone Formulation probiotic blend; C, HD plus AISA d-Limonene; D, HD plus Argan oil']","['inflammatory parameters, mental (MCS) and physical (PCS) component summaries of HRQoL (SF-36), anxiety symptoms (STAI state), and depressive symptoms (CES-D', 'HRQoL, anxiety, and depressive symptoms', 'Body fat mass proportion (BFM', 'Depression symptoms and lower health-related quality of life (HRQoL', 'anxiety or PCS-HRQoL', 'MCS-HRQoL', 'CES-D score', 'depressive symptoms']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0950252', 'cui_str': 'Limonene, (+)-'}, {'cui': 'C2975054', 'cui_str': 'argan oil'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",125.0,0.0397556,"A decrease of CES-D score was seen in the four arms (A: -40.0%, p = 0.001; B: -32.5%, p = 0.023; C: -42.8%, p = 0.004; and D: -33.3%, p = 0.21).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bourdel-Marchasson', 'Affiliation': 'CRMSB UMR 5536, Université Bordeaux/CNRS, F-33000 Bordeaux, France.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Ostan', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Regueme', 'Affiliation': 'CHU Bordeaux, Pôle de gérontologie, Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Experimental Medicine Department, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Pryen', 'Affiliation': 'Mendes SA, Via Giacometti 1 - CH-6900 Lugano, Switzerland.'}, {'ForeName': 'Zoubida', 'Initials': 'Z', 'LastName': 'Charrouf', 'Affiliation': 'Department of Chemistry, University Mohammed V, BP 1014, Rabat, Morocco.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': ""d'Alessio"", 'Affiliation': 'AISA (Anti-Inflammatory Senescence Actives) Therapeutics, 94807 Villejuif, France.'}, {'ForeName': 'Claire Roubaud', 'Initials': 'CR', 'LastName': 'Baudron', 'Affiliation': 'CHU Bordeaux, Pôle de gérontologie, Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Guerville', 'Affiliation': 'CHU Bordeaux, Pôle de gérontologie, Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Durrieu', 'Affiliation': 'CHU Bordeaux, Pôle de gérontologie, Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'Lorenzo M', 'Initials': 'LM', 'LastName': 'Donini', 'Affiliation': 'Experimental Medicine Department, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Franceschi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Luzia', 'Initials': 'L', 'LastName': 'Valentini', 'Affiliation': 'Department Gastroenterology and Hepatology, Charité Universitätsmedizin Berlin, 10117 Berlin, Germany.'}]",Nutrients,['10.3390/nu12030800'] 322,31725196,"Every-other-day palonosetron plus aprepitant for prevention of emesis following induction chemotherapy for acute myeloid leukemia: A randomized, controlled study from the ""Rete Ematologica Pugliese"".","BACKGROUND Compared with older 5-HT 3 receptor antagonists, palonosetron requires fewer drug administrations to prevent chemotherapy-induced nausea and vomiting (CINV) following multiple-day chemotherapy. We conducted a phase II multicenter study comparing palonosetron plus aprepitant to palonosetron alone in patients undergoing a range of induction chemotherapy regimens for acute myeloid leukemia (AML). METHODS Patients were randomized to palonosetron (0.25 mg) every other day until the last dose of chemotherapy alone or with aprepitant on days 1-3. Patients mainly received an anthracycline on days 1-3 plus cytarabine administered for 5-10 days. The primary end point was complete response (CR; no emesis and no rescue medication) over the whole study period (days of chemotherapy plus two additional days). Unplanned analysis of time to anti-emetic treatment failure (TTF) was also performed. RESULTS Of the 134 patients enrolled in the study, 130 were evaluable: 68 subjects received palonosetron plus aprepitant and 62 received palonosetron alone. Although the primary end point of CR was similar between the treatment arms (72% vs 69%; P = .55), a higher proportion of patients treated with palonosetron plus aprepitant were free from nausea during the whole study period (43% vs 27%; P = .03). There was also a significant difference in favor of the two-drug regimens in TTF (median: 5 days vs 3 days; P = .03). CONCLUSIONS The study suggests that every-other-day palonosetron plus 3-day aprepitant can add clinical benefit to the control of CINV caused by multiple-day, corticosteroid-free chemotherapy for AML. In this challenging setting of CINV, further investigations of palonosetron in combination with aprepitant administered with an expanded schedule are warranted. ClinicalTrial.gov identifier: NCT02205164.",2020,The primary end point was complete response (CR; no emesis and no rescue medication) over the whole study period (days of chemotherapy plus two additional days).,"['Patients', '134 patients enrolled in the study', 'acute myeloid leukemia', 'patients undergoing a range of induction chemotherapy regimens for acute myeloid leukemia (AML', ' 130 were evaluable: 68 subjects received']","['palonosetron plus aprepitant and 62 received palonosetron alone', 'anthracycline', 'palonosetron plus aprepitant to palonosetron alone', 'palonosetron', 'chemotherapy alone or with aprepitant on days 1-3', 'cytarabine']","['Unplanned analysis of time to anti-emetic treatment failure (TTF', 'nausea and vomiting (CINV', 'CR', 'complete response (CR; no emesis and no rescue medication', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0162643'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",68.0,0.0485286,The primary end point was complete response (CR; no emesis and no rescue medication) over the whole study period (days of chemotherapy plus two additional days).,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Di Renzo', 'Affiliation': 'Department of Hematology and Stem Cell Transplant, Presidio Ospedaliero Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Melillo', 'Affiliation': 'Hematology Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Porretto', 'Affiliation': 'Hematology Unit, Casa di Cura La Maddalena, Palermo, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Dargenio', 'Affiliation': 'Department of Hematology and Stem Cell Transplant, Presidio Ospedaliero Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pavone', 'Affiliation': 'Hematology Unit, Ospedale Cardinale G. Panico, Tricase, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Pastore', 'Affiliation': 'Hematology Unit, Ospedale A. Perrino, Brindisi, Italy.'}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Mazza', 'Affiliation': 'Hematology Unit, Ospedale S.G. Moscati, Taranto, Italy.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Mannina', 'Affiliation': 'Hematology Unit, A.O. Ospedali Riuniti Papardo-Piemonte, Messina, Italy.'}, {'ForeName': 'Anxur', 'Initials': 'A', 'LastName': 'Merenda', 'Affiliation': 'Hematology Unit, Ospeale Civico, Palermo, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cascavilla', 'Affiliation': 'Hematology Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Greco', 'Affiliation': 'Hematology Unit, Ospedale Cardinale G. Panico, Tricase, Italy.'}, {'ForeName': 'Rosella', 'Initials': 'R', 'LastName': 'Matera', 'Affiliation': 'Department of Hematology and Stem Cell Transplant, Presidio Ospedaliero Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Erminio', 'Initials': 'E', 'LastName': 'Bonizzoni', 'Affiliation': 'Section of Medical Statistics, Biometry and Epidemiology, University of Milan, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Celio', 'Affiliation': 'Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Musso', 'Affiliation': 'Hematology Unit, Casa di Cura La Maddalena, Palermo, Italy.'}]",Cancer medicine,['10.1002/cam4.2628'] 323,30879731,The Protective Effect of Prenatal Social Support on Infant Adiposity in the First 18 Months of Life.,"OBJECTIVE To determine whether prenatal social support was associated with infant adiposity in the first 18 months of life in a low-income, Hispanic sample, known to be at high risk of early child obesity. STUDY DESIGN We performed a longitudinal analysis of 262 low-income, Hispanic mother-infant pairs in the control group of the Starting Early child obesity prevention trial. Prenatal social support was measured using an item from the Maternal Social Support Index. We used multilevel modeling to predict weight-for-length z-score trajectories from birth to age 18 months and logistic regression to predict macrosomia and overweight status at ages 6, 12, and 18 months. RESULTS High prenatal social support was independently associated with lower infant adiposity trajectories from birth to age 18 months (B = -0.40; 95% CI, -0.63 to -0.16), a lower odds of macrosomia (aOR = 0.35; 95% CI, 0.15-0.80), and a lower odds of overweight at ages 12 (aOR = 0.28; 95% CI, 0.10-0.74) and 18 months (aOR = 0.35; 95% CI, 0.14-0.89). Prenatal social support was not significantly associated with overweight status at age 6 months. CONCLUSIONS Prenatal social support may protect against excessive infant adiposity and overweight in low-income, Hispanic families. Further research is needed to elucidate mechanisms underlying these associations and to inform preventive strategies beginning in pregnancy.",2019,"Prenatal social support was not significantly associated with overweight status at age 6 months. ","['262 low-income, Hispanic mother-infant pairs in the control group of the Starting Early child obesity prevention trial']",['Prenatal Social Support'],"['lower infant adiposity trajectories', 'Infant Adiposity', 'Prenatal social support']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",262.0,0.0244526,"Prenatal social support was not significantly associated with overweight status at age 6 months. ","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Katzow', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY. Electronic address: michelle.katzow@nyumc.org.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Scott', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, New York University Steinhardt School of Culture, Education, and Human Development, New York, NY.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.02.017'] 324,32293830,"Trauma, treatment and Tetris: video gaming increases hippocampal volume in male patients with combat-related posttraumatic stress disorder.","Background Tetris has been proposed as a preventative intervention to reduce intrusive memories of a traumatic event. However, no neuroimaging study has assessed Tetris in patients with existing posttraumatic stress disorder (PTSD) or explored how playing Tetris may affect brain structure. Methods We recruited patients with combat-related PTSD before psychotherapy and randomly assigned them to an experimental Tetris and therapy group (n = 20) or to a therapy-only control group (n = 20). In the control group, participants completed therapy as usual: eye movement desensitization and reprocessing (EMDR) psychotherapy. In the Tetris group, in addition to EMDR, participants also played 60 minutes of Tetris every day from onset to completion of therapy, approximately 6 weeks later. Participants completed structural MRI and psychological questionnaires before and after therapy, and we collected psychological questionnaire data at follow-up, approximately 6 months later. We hypothesized that the Tetris group would show increases in hippocampal volume and reductions in symptoms, both directly after completion of therapy and at follow-up. Results Following therapy, hippocampal volume increased in the Tetris group, but not the control group. As well, hippocampal increases were correlated with reductions in symptoms of PTSD, depression and anxiety between completion of therapy and follow-up in the Tetris group, but not the control group. Limitations Playing Tetris may act as a cognitive interference task and as a brain-training intervention, but it was not possible to distinguish between these 2 potential mechanisms. Conclusion Tetris may be useful as an adjunct therapeutic intervention for PTSD. Tetris-related increases in hippocampal volume may ensure that therapeutic gains are maintained after completion of therapy.",2020,"As well, hippocampal increases were correlated with reductions in symptoms of PTSD, depression and anxiety between completion of therapy and follow-up in the Tetris group, but not the control group. ","['male patients with combat-related posttraumatic stress disorder', 'patients with combat-related PTSD before psychotherapy and randomly assigned them to an experimental Tetris and therapy group (n = 20) or to a therapy-only control group (n = 20', 'patients with existing posttraumatic stress disorder (PTSD']","['usual: eye movement desensitization and reprocessing (EMDR) psychotherapy', 'Tetris: video gaming']","['collected psychological questionnaire data', 'structural MRI and psychological questionnaires', 'hippocampal volume', 'symptoms of PTSD, depression and anxiety']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0274997,"As well, hippocampal increases were correlated with reductions in symptoms of PTSD, depression and anxiety between completion of therapy and follow-up in the Tetris group, but not the control group. ","[{'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Butler', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Herr', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Willmund', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': 'From the Max Planck Institute for Human Development, Center for Lifespan Psychology, Berlin, Germany (Butler, Kühn); the Center for Military Mental Health, Military Hospital Berlin, Berlin, Germany (Herr, Willmund, Zimmermann); and the University Medical Centre Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Gallinat, Kühn).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190027'] 325,31756059,Similar overall survival with reduced vs. standard dose bevacizumab monotherapy in progressive glioblastoma.,"INTRODUCTION Bevacizumab has demonstrated activity in glioblastoma (GBM), but the true benefits and optimal dose-schedule are debated. A lower dose-schedule than standard-dose bevacizumab (10 mg/kg 2-weekly) might offer similar benefits with lower costs. At our Institution, patients are randomly assigned at time of primary diagnosis to Neuro-Oncologists, who have varying practices in terms of bevacizumab dose-schedule upon progression. METHODS In a retrospective analysis we examined overall survival (OS), measured from first administered bevacizumab dose until death, according to dose-schedule. Patients with de novo WHO Grade IV GBM who received standard- or reduced-dose (5 mg/kg 2-weekly) bevacizumab were included. MGMT methylation status and time from diagnosis to bevacizumab start were examined as prognostic variables. Clinical benefit and a comparative cost analysis were assessed. RESULTS In total, 1127 bevacizumab doses were administered to 118 patients [Median: 7, Range: 1-44]. Median OS (mOS) was 5.8 months. 69 (59%) patients received standard-dose bevacizumab (mOS: 5.97 months) and 49 patients received reduced-dose (mOS: 5.7 months). No statistically significant difference in OS between dosing schedule was seen (HR: 1.11, P-value: .584). Patients with MGMT methylated tumors (43%) had improved OS compared to those with unmethylated tumors; 7.03 vs 4.97 months (HR: 0.61, P-value: .027). If all patients were treated with reduced-dose bevacizumab, an estimated €2.4M cost reduction would be observed. CONCLUSIONS In this retrospective study, reduced-dose bevacizumab schedule resulted in similar OS to standard-dose bevacizumab monotherapy with substantial cost savings. MGMT methylation appears to convey a survival benefit in the setting of bevacizumab treatment for progressive GBM.",2020,"No statistically significant difference in OS between dosing schedule was seen (HR: 1.11, P-value: .584).",['Patients with de novo'],"['bevacizumab monotherapy', 'bevacizumab', 'Bevacizumab', 'standard-dose bevacizumab']","['OS', 'overall survival', 'overall survival (OS', 'survival benefit', 'Median OS (mOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1127.0,0.117465,"No statistically significant difference in OS between dosing schedule was seen (HR: 1.11, P-value: .584).","[{'ForeName': 'Jack Patrick', 'Initials': 'JP', 'LastName': 'Gleeson', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Keane', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Niamh M', 'Initials': 'NM', 'LastName': 'Keegan', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Emin', 'Initials': 'E', 'LastName': 'Mammadov', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Harrold', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alhusaini', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Harte', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Eakin-Love', 'Affiliation': 'Royal College of Surgeons of Ireland (RCSI), Dublin, Ireland.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': ""O'Halloran"", 'Affiliation': 'Neurosurgical Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'MacNally', 'Affiliation': 'Neurosurgical Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Bryan T', 'Initials': 'BT', 'LastName': 'Hennessy', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Oscar S', 'Initials': 'OS', 'LastName': 'Breathnach', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Grogan', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Morris', 'Affiliation': 'Medical Oncology Department, Beaumont Hospital, Dublin, Ireland.'}]",Cancer medicine,['10.1002/cam4.2616'] 326,31758610,UCC118 supplementation reduces exercise-induced gastrointestinal permeability and remodels the gut microbiome in healthy humans.,"Dysregulation of gut microbiota and intestinal barrier function has emerged as potential mechanisms underlying digestive diseases, yet targeted therapies are lacking The purpose of this investigation was to assess the efficacy of UCC118, a characterized probiotic strain, on exercise-induced GI permeability in healthy humans. In a randomized, double-blind, placebo-controlled crossover study, seven healthy adults received 4 weeks of daily UCC118 or placebo supplementation. GI hyperpermeability was induced by strenuous treadmill running performed before and after each supplementation period. While running, participants ingested 5 g of lactulose, rhamnose, and sucrose. Urine was collected before, immediately after, and every hour for 5 h after exercise to assess GI permeability. Metagenomic sequencing was performed on fecal homogenates collected prior to exercise to identify changes in microbial diversity and taxon abundances. Inflammatory biomarkers were assessed from blood and fecal homogenates collected prior to and immediately following the cessation of exercise. Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001). UCC118 significantly reduced sucrose (Δ = -0.38 ± 0.13 vs. 1.69 ± 0.79; P < 0.05) recovery, with no substantial change in lactulose (Δ = -0.07 ± 0.23 vs. 0.35 ± 0.15; P = 0.16) or rhamnose (Δ = -0.06 ± 0.22 vs. 0.48 ± 0.28; P = 0.22). Taxonomic sequencing revealed 99 differentially regulated bacteria spanning 6 taxonomic ranks (P < 0.05) after UCC118 supplementation. No differences in plasma IL-6 or fecal zonulin were observed after UCC118 supplementation. The results described herein provide proof of principle that 4 weeks of UCC118 supplementation attenuated exercise-induced intestinal hyperpermeability. Further research is warranted to investigate the as-yet-to-be defined molecular processes of intestinal hyperpermeability and the effects of probiotic supplementation.",2019,"Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001).","['seven healthy adults', 'healthy humans']","['placebo', 'UCC118 supplementation', 'UCC118 or placebo supplementation']","['Inflammatory biomarkers', 'intestinal hyperpermeability', 'GI hyperpermeability', 'plasma IL-6 or fecal zonulin', 'intestinal permeability of lactulose, rhamnose, and sucrose']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0035417', 'cui_str': 'rhamnose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]",,0.200239,"Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001).","[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Connery J', 'Initials': 'CJ', 'LastName': 'Brennan', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Cresci', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hull', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Ciarán E', 'Initials': 'CE', 'LastName': 'Fealy', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}]",Physiological reports,['10.14814/phy2.14276'] 327,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN Parallel-group, quasi-experimental study. OBJECTIVES To evaluate the effectiveness of a coping-oriented supportive programme (COSP) for people with spinal cord injury (SCI) over a 12-week follow-up. SETTING SCI wards in two rehabilitation hospitals of Shaanxi, China. METHODS Ninety-nine participants (mean age = 41, 88% males and 74% paraplegia) joined the COSP intervention (n = 50) or attention control (n = 49) group. The COSP intervention was focussed on the facilitation of coping skills and consisted of 8 weekly sessions, whereas the attentional control group was provided with 8 weekly didactic education sessions. Effects of the COSP intervention were determined by primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain). Data were collected at pre- and post-intervention, as well as 4- and 12-week follow-up. RESULTS Intention to treat analysis indicated statistically significant effects (with moderate to large effect sizes, all P-values < 0.01) on participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction immediately post-COSP. Statistically significant effects were found for maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction at 4-week follow-up. Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up. CONCLUSION The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up. ","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up. ","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2'] 328,31462757,Sprint interval training versus moderate-intensity continuous training during inpatient rehabilitation after spinal cord injury: a randomized trial.,"STUDY DESIGN Randomized trial. OBJECTIVES To evaluate the effectiveness of a 5-week sprint interval training (SIT) protocol on an arm-crank ergometer in individuals with sub-acute spinal cord injury (SCI). SETTING Inpatient rehabilitation. METHODS Individuals with SCI (N = 20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46 ± 16 years; 15 M/5 F) were randomized to SIT or moderate-intensity continuous training (MICT). SIT consisted of 3 × 20 s. 'all-out' cycle sprints (≥100% peak power output) interspersed with 2 min of active recovery (10% peak power output; total time commitment, 10 mins). MICT involved 20 min of cycling (45% peak power output; total time commitment, 25 mins). Both training interventions were delivered 3 times/week for 5 weeks. Heart rate and Borg's Rating of Perceived Exertion (RPE; 6-20) were monitored throughout training sessions. Maximal and sub-maximal power outputs were assessed on an arm-crank ergometer. Exercise enjoyment, exercise self-efficacy, and pain were assessed at the end of the intervention. RESULTS During training sessions, heart rate (135 bpm vs. 119 bpm; p = 0.05), peripheral RPE (16 vs. 12; p = 0.000), and central RPE (15 vs. 11; p = 0.004) responses were higher in the SIT group, yet total work performed was greater in MICT. Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524). Similarly, improvements in sub-maximal power output were not different across groups. There were no between-group differences in exercise enjoyment (p = 0.385), exercise self-efficacy (p = 0.930), or pain (p = 0780). CONCLUSIONS Five weeks of SIT improved physical capacity to the same extent as MICT in individuals with sub-acute SCI, despite a significantly lower time commitment with SIT.",2020,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","['inpatient rehabilitation after spinal cord injury', 'Individuals with SCI (N\u2009', 'Inpatient rehabilitation', '20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46\u2009±\u200916 years; 15\u2009M/5\u2009F', 'individuals with sub-acute spinal cord injury (SCI']","['MICT', 'SIT or moderate-intensity continuous training (MICT', 'Sprint interval training versus moderate-intensity continuous training', '5-week sprint interval training (SIT) protocol']","['sub-maximal power output', 'Exercise enjoyment, exercise self-efficacy, and pain', ""Heart rate and Borg's Rating of Perceived Exertion"", 'Peak power output', 'heart rate', 'physical capacity', 'exercise enjoyment', 'peripheral RPE', 'exercise self-efficacy', 'central RPE']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0449246', 'cui_str': 'Time since injury (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",780.0,0.0764155,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Mcleod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Herrington', 'Initials': 'H', 'LastName': 'Diana', 'Affiliation': 'Regional Rehabilitation Centre, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada. hicksal@mcmaster.ca.'}]",Spinal cord,['10.1038/s41393-019-0345-6'] 329,31710994,Individual differences in human opioid abuse potential as observed in a human laboratory study.,"BACKGROUND Opioids have high abuse potential and pose a major public health concern. Yet, a large percentage of individuals exposed to opioids do not develop problematic use. Individual differences in opioid abuse potential are not well understood. METHODS This within-subject (N = 16), double-blind, double-dummy, human laboratory study evaluated individual differences in response to dose (placebo, low, medium, high) following administration of heroin and hydromorphone through intravenous and subcutaneous routes, in opioid-experienced but non physically-dependent participants. Outcomes were self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire. The degree to which results were consistent across measures within an individual was assessed using a mixed-effects model from which an intraclass correlation coefficient measure of between and within-subject variance was derived. RESULTS The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent. Visual inspection reveals a myriad response pattern across participants, with some demonstrating classic dose-effect responses and others not differentiating any active doses from placebo. CONCLUSIONS Data suggest the abuse potential of opioids is significantly different between individuals but that the experience within an individual is highly consistent. Research to prospectively characterize and evaluate mechanisms underlying these differences is warranted and may provide a foundation to help identify persons at heightened risk of transitioning from opioid exposure to misuse and/or opioid use disorder.",2019,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.",[],['heroin and hydromorphone'],"['self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire']",[],"[{'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443052', 'cui_str': 'Rush (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.212725,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dunn', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States. Electronic address: kdunn9@jhmi.edu.'}, {'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': 'Health Canada, Canada; Centre for Addiction and Mental Health, Canada; University of Toronto, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Marsh', 'Affiliation': 'Northern Ontario School of Medicine, Canada.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107688'] 330,31312016,Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial.,"STUDY DESIGN Randomized controlled trial. OBJECTIVE To determine the effects of advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES) of the quadriceps and gastrocnemius muscles on the ability of wheelchair-dependent people with spinal cord injury (SCI) to transfer and attain independence in activities of daily living (ADLs). SETTING An outpatient clinic, Iran. METHODS People with traumatic chronic paraplegia (N = 16) were randomly allocated to three groups. The exercise group (EX; N = 5) performed AWMEs of quadruped unilateral reaching and tall-kneeling for 24 weeks (3 days/week). Sessions were increased from 10 min to 54 min over the 24-week period. The exercise-FES group (EX + FES; N = 5) performed AWMEs simultaneously with FES of the quadriceps and gastrocnemius muscles. The control group performed no exercise and no FES (N = 6). The primary outcomes were the total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer. There were six other outcomes. RESULTS The mean (95% CI) between-group differences of the four transfer items of the SCIM-III for the EX vs. control group was 1.8 points (0.2-3.4), and for the EX + FES vs. control group was 2 points (0.4-3.6). The equivalent differences for the total SCIM-III scores were 2.7 points (-0.6-6.0) and 4.1 points (0.8-7.4), respectively. There were no significant between-group differences for any other outcomes. CONCLUSIONS Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.",2020,"CONCLUSIONS Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","['People with traumatic chronic paraplegia (N\u2009=\u200916', 'wheelchair-dependent people with spinal cord injury (SCI', 'An outpatient clinic, Iran']","['no exercise and no FES', 'advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES', 'Advanced weight-bearing mat exercises combined with functional electrical stimulation', 'exercise group (EX; N\u2009=\u20095) performed AWMEs of quadruped unilateral reaching and tall-kneeling']","['total SCIM-III scores', 'total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C3698571', 'cui_str': 'Chronic paraplegia'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456677', 'cui_str': 'Total spinal blockade (finding)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0665244,"CONCLUSIONS Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Torkaman', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. torkamg@modares.ac.ir.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Ghabaee', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Departments of Medicine and Endocrinology, Austin Health, The University of Melbourne, Melbourne, VIC, Australia.'}]",Spinal cord,['10.1038/s41393-019-0328-7'] 331,31240128,Comparison of abdominal compression devices in persons with abdominal paralysis due to spinal cord injury.,"Study Design Single subject design with five subjects. Objectives The objetive of this study is to compare the effectiveness and usability of alternative commercial abdominal compression garments with participants' usual medical binders. Setting Private residences in Pierce and King Counties, WA, USA. Methods Participants wore each garment for 5 days followed by a 2-day washout in personal binder. Week 1: Personal binder. Weeks 2 and 3: Randomly ordered test garments (tank, bodysuit). Physiologic measurements: blood pressure (SBP, DBP), blood oxygen saturation (SaO 2 ), forced expiratory volume in one second (FEV 1 ), and heart rate (HR). Participants completed logs twice daily for 5 days per garment regarding ease of use, comfort, respiration, and appearance. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research. Results The use of a personal binder results in significant increases in SBP and FEV 1 . Personal binders support FEV 1 significantly better than test garments. There is no difference in SBP between test garments and personal binders. There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder. Participants reported that neither tank nor bodysuit felt adequately supportive or easy to use. Conclusions Abdominal compression improves respiratory function and supports SBP in individuals with chronic SCI. Further research is needed to guide the development of an easy-to-use and physiologically supportive abdominal compression garment.",2019,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","['persons with abdominal paralysis due to spinal cord injury', 'human volunteers', 'five subjects', 'individuals with chronic SCI', 'Setting\n\n\nPrivate residences in Pierce and King Counties, WA, USA.\nMethods']","['abdominal compression devices', 'alternative commercial abdominal compression garments', ' Randomly ordered test garments (tank, bodysuit']","['SBP and FEV 1 ', 'DBP, SaO 2 , or HR', 'SBP', 'respiratory function', 'Physiologic measurements: blood pressure (SBP, DBP), blood oxygen saturation (SaO 2 ), forced expiratory volume in one second (FEV 1 ), and heart rate (HR']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0336821', 'cui_str': 'Tank - military vehicle (physical object)'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0199213', 'cui_str': 'Physiologic measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",5.0,0.0276293,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","[{'ForeName': 'Michaela de', 'Initials': 'M', 'LastName': 'Groot', 'Affiliation': '1University of Puget Sound, Tacoma, WA USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swartz', 'Affiliation': '2University of Puget Sound, 1500 N Warner St. CMB 1030, 98416 Tacoma, WA USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hastings', 'Affiliation': '2University of Puget Sound, 1500 N Warner St. CMB 1030, 98416 Tacoma, WA USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0176-x'] 332,31587565,High-Sensitivity Cardiac Troponin and the Universal Definition of Myocardial Infarction.,"BACKGROUND The introduction of more sensitive cardiac troponin assays has led to increased recognition of myocardial injury in acute illnesses other than acute coronary syndrome. The Universal Definition of Myocardial Infarction recommends high-sensitivity cardiac troponin testing and classification of patients with myocardial injury based on pathogenesis, but the clinical implications of implementing this guideline are not well understood. METHODS In a stepped-wedge cluster randomized, controlled trial, we implemented a high-sensitivity cardiac troponin assay and the recommendations of the Universal Definition in 48 282 consecutive patients with suspected acute coronary syndrome. In a prespecified secondary analysis, we compared the primary outcome of myocardial infarction or cardiovascular death and secondary outcome of noncardiovascular death at 1 year across diagnostic categories. RESULTS Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1233) and 43% (389/898), respectively. Compared with those without myocardial injury, the rate of the primary outcome was highest in those with type 1 myocardial infarction (cause-specific hazard ratio [HR] 5.64 [95% CI, 5.12-6.22]), but was similar across diagnostic categories, whereas noncardiovascular deaths were highest in those with acute myocardial injury (cause specific HR 2.65 [95% CI, 2.33-3.01]). Despite modest increases in antiplatelet therapy and coronary revascularization after implementation in patients with type 1 myocardial infarction, the primary outcome was unchanged (cause specific HR 1.00 [95% CI, 0.82-1.21]). Increased recognition of type 2 myocardial infarction and myocardial injury did not lead to changes in investigation, treatment or outcomes. CONCLUSIONS Implementation of high-sensitivity cardiac troponin assays and the recommendations of the Universal Definition of Myocardial Infarction identified patients at high-risk of cardiovascular and noncardiovascular events but was not associated with consistent increases in treatment or improved outcomes. Trials of secondary prevention are urgently required to determine whether this risk is modifiable in patients without type 1 myocardial infarction. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov. Unique identifier: NCT01852123.",2020,"Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4,471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1,233) and 43% (389/898), respectively.","['patients with type 1 myocardial infarction', 'patients without type 1 myocardial infarction', '48,282 consecutive patients with suspected acute coronary syndrome', 'patients with myocardial injury']",[],"['myocardial infarction or cardiovascular death and secondary outcome of non-cardiovascular death at one year across diagnostic categories', 'non-cardiovascular deaths', 'type 2 myocardial infarction', 'diagnosis of type 1 myocardial infarction', 'myocardial infarction (cause-specific hazard ratio [csHR', 'acute and chronic myocardial injury', 'anti-platelet therapy and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",[],"[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",,0.358692,"Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4,471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1,233) and 43% (389/898), respectively.","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Strachan', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Amy V', 'Initials': 'AV', 'LastName': 'Ferry', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Kuan', 'Initials': 'K', 'LastName': 'Ken Lee', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences (C.B.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Findlay', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (I.F.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cruikshank', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom (A.C., A.R.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom (A.C., A.R.).'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Emergency Medicine Research Group Edinburgh, Royal Infirmary of Edinburgh, United Kingdom (A.G.).'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Collinson', 'Affiliation': ""Departments of Clinical Blood Sciences and Cardiology, St George's, University Hospitals NHS Trust and St George's University of London, United Kingdom (P.O.C.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Apple', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Hennepin Healthcare/Hennepin County Medical Center & University of Minnesota, Minneapolis (F.A.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing (D.A.McA.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Donogh', 'Initials': 'D', 'LastName': 'Maguire', 'Affiliation': 'Emergency Medicine Department, Glasgow Royal Infirmary, United Kingdom (D.M).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Catalina A', 'Initials': 'CA', 'LastName': 'Vallejos', 'Affiliation': 'MRC Human Genetics Unit (C.A.V.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Keerie', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.K., C.J.W.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.K., C.J.W.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042960'] 333,31612956,Cannabis and Alcohol Co-Use in a Smoking Cessation Pharmacotherapy Trial for Adolescents and Emerging Adults.,"INTRODUCTION The co-use of cannabis and alcohol among tobacco-using youth is common. Alcohol co-use is associated with worse tobacco cessation outcomes, but results are mixed regarding the impact of cannabis on tobacco outcomes and if co-use leads to increased use of non-treated substances. This secondary analysis from a youth smoking cessation trial aimed to (1) evaluate the impact of cannabis or alcohol co-use on smoking cessation, (2) examine changes in co-use during the trial, and (3) explore secondary effects of varenicline on co-use. METHODS The parent study was a 12-week, randomized clinical trial of varenicline for smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White). Daily cigarette, cannabis, and alcohol use data were collected via daily diaries during treatment and Timeline Follow-back for 14 weeks post-treatment. RESULTS Baseline cannabis co-users (68%) had double the odds of continued cigarette smoking throughout the trial compared with noncannabis users, which was pronounced in males and frequent cannabis users. Continued smoking during treatment was associated with higher probability of concurrent cannabis use. Baseline alcohol co-users (80%) did not have worse smoking outcomes compared with nonalcohol users, but continued smoking was associated with higher probability of concurrent drinking. Varenicline did not affect co-use. CONCLUSIONS Inconsistent with prior literature, results showed that alcohol co-users did not differ in smoking cessation, whereas cannabis co-users had poorer cessation outcomes. Youth tobacco treatment would benefit from added focus on substance co-use, particularly cannabis, but may need to be tailored appropriately to promote cessation. IMPLICATIONS Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation.",2019,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","['youth cigarette smokers', 'Adolescents and Emerging Adults', 'smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White']","['varenicline', 'cannabis or alcohol co-use', 'Varenicline']",['cigarette smoking'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",,0.0318818,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz170'] 334,29978597,Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition.,"BACKGROUND The catheter lock solutions 2% taurolidine and 0.9% saline are both used to prevent catheter-related bloodstream infections (CRBSIs) in home parenteral nutrition patients. AIMS To compare the effectiveness and safety of taurolidine and saline. METHODS This multicentre double-blinded trial randomly assigned home parenteral nutrition patients to use either 2% taurolidine or 0.9% saline for 1 year. Patients were stratified in a new catheter group and a pre-existing catheter group. Primary outcome was the rate of CRBSIs/1000 catheter days in the new catheter group and pre-existing catheter group, separately. RESULTS We randomised 105 patients, of which 102 were analysed as modified intention-to-treat population. In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009). In the pre-existing catheter group, rates of CRBSIs/1000 catheter days were 0.39 and 1.32 in the taurolidine and saline arm respectively (relative risk, 0.30; 95% CI, 0.03-1.82; P = 0.25). Excluding one outlier patient in the taurolidine arm, mean costs per patient were $1865 for taurolidine and $4454 for saline (P = 0.03). Drug-related adverse events were rare and generally mild. CONCLUSIONS In the new catheter group, taurolidine showed a clear decrease in CRBSI rate. In the pre-existing catheter group, no superiority of taurolidine could be demonstrated, most likely due to underpowering. Overall, taurolidine reduced the risk for CRBSIs by more than four times. Given its favourable safety and cost profile, taurolidine locking should be considered as an additional strategy to prevent CRBSIs. TRIAL REGISTRATION Clinicaltrials.gov, identifier: NCT01826526.",2018,"In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009).","['105 patients, of which 102 were analysed as modified intention-to-treat population', 'home parenteral nutrition patients', 'patients on home parenteral nutrition']","['saline locking', 'parenteral nutrition patients to use either 2% taurolidine or 0.9% saline', 'taurolidine and saline', 'taurolidine', 'taurolidine locking']","['mean costs per patient', 'rates of CRBSIs/1000 catheter days', 'CRBSI rate', 'effectiveness and safety', 'rate of CRBSIs/1000 catheter days', 'risk for CRBSIs']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0079543', 'cui_str': 'Parenteral Nutrition, Home'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0144567', 'cui_str': 'taurolidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.390806,"In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wouters', 'Affiliation': 'Intestinal Failure Unit, Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The\xa0Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Theilla', 'Affiliation': 'General Intensive Care Department, Rabin Medical Centre, Beilinson Hospital and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'General Intensive Care Department, Rabin Medical Centre, Beilinson Hospital and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tribler', 'Affiliation': 'Department of Medical Gastroenterology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Medical Gastroenterology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pironi', 'Affiliation': 'Centre for Chronic Intestinal Failure, Department of Medical and Surgical Science, University of Bologna, Bologna, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vinter-Jensen', 'Affiliation': 'Department of Gastroenterology, Centre for Nutrition and Bowel Disease, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Gastroenterology, Centre for Nutrition and Bowel Disease, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rahman', 'Affiliation': 'Department of Gastroenterology, University College London Hospital, London, UK.'}, {'ForeName': 'G J A', 'Initials': 'GJA', 'LastName': 'Wanten', 'Affiliation': 'Intestinal Failure Unit, Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The\xa0Netherlands.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.14904'] 335,30660402,"A prospective, double-blind, randomized, placebo-controlled study on the efficacy and safety of influenza vaccination in myasthenia gravis.","OBJECTIVE To investigate the efficacy and safety of an influenza vaccination in patients with myasthenia gravis with acetylcholine receptor antibodies (AChR MG). METHODS An influenza vaccination or placebo was administered to 47 AChR MG patients. Before and 4 weeks after administration blood samples and clinical outcome scores were obtained. Antibodies to the vaccine strains A/California/7/2009 (H1N1)pdm09, A/Hong Kong/4801/14 (H3N2) and B/Brisbane/060/08 were measured using the hemagglutination-inhibition (HI) assay and disease-specific AChR antibody titers were measured with a radio-immunoprecipitation assay. Forty-seven healthy controls (HC) were vaccinated with the same influenza vaccine to compare antibody titers. RESULTS A post-vaccination, seroprotective titer (HI ≥ 1:40) was achieved in 89.4% of MG patients vs. 93.6% in healthy controls for the H3N2 strain, 95.7% vs 97.9% for the H1N1 strain and 46.8 vs 51% for the B-strain. A seroprotective titer for all three strains of the seasonal influenza vaccine was reached in 40.4% (19/47) of the MG group and in 51% (24/47) of the HC group. Immunosuppressive medication did not significantly influence post geomean titers (GMT). The titers of disease-specific AChR antibodies were unchanged 4 weeks after vaccination. The clinical outcome scores showed no exacerbation of MG symptoms. CONCLUSION The antibody response to an influenza vaccination in patients with AChR MG was not different from that in healthy subjects, even in AChR MG patients using immunosuppressive medication. Influenza vaccination does not induce an immunological or clinical exacerbation of AChR MG. CLINICAL TRIAL REGISTRY The influenza trial is listed on clinicaltrialsregister.eu under 2016-003138-26.",2019,"Antibodies to the vaccine strains A/California/7/2009 (H1N1)pdm09, A/Hong Kong/4801/14 (H3N2) and B/Brisbane/060/08 were measured using the hemagglutination-inhibition (HI) assay and disease-specific AChR antibody titers were measured with a radio-immunoprecipitation assay.","['patients with myasthenia gravis with acetylcholine receptor antibodies (AChR MG', 'Forty-seven healthy controls (HC', 'myasthenia gravis', 'clinicaltrialsregister.eu under 2016-003138-26']","['influenza vaccine', 'influenza vaccination', 'placebo', 'Influenza vaccination']","['antibody response', 'seroprotective titer', 'titers of disease-specific AChR antibodies', 'exacerbation of MG symptoms', 'efficacy and safety', 'hemagglutination-inhibition (HI) assay and disease-specific AChR antibody titers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0947912'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",47.0,0.177307,"Antibodies to the vaccine strains A/California/7/2009 (H1N1)pdm09, A/Hong Kong/4801/14 (H3N2) and B/Brisbane/060/08 were measured using the hemagglutination-inhibition (HI) assay and disease-specific AChR antibody titers were measured with a radio-immunoprecipitation assay.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Strijbos', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, the Netherlands. Electronic address: e.strijbos@lumc.nl.'}, {'ForeName': 'Martijn R', 'Initials': 'MR', 'LastName': 'Tannemaat', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Alleman', 'Affiliation': 'Department of Physiotherapy, Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Robert H P', 'Initials': 'RHP', 'LastName': 'de Meel', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Bakker', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'van Beek', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Kroon', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Guus F', 'Initials': 'GF', 'LastName': 'Rimmelzwaan', 'Affiliation': 'Research Center for Emerging Infections and Zoonoses, University of Veterinary Medicine, Hannover, Germany.'}, {'ForeName': 'Jan J G M', 'Initials': 'JJGM', 'LastName': 'Verschuuren', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, the Netherlands.'}]",Vaccine,['10.1016/j.vaccine.2019.01.007'] 336,30671535,Effects of high dose atorvastatin before elective percutaneous coronary intervention on highly sensitive troponin T and one year major cardiovascular events; a randomized clinical trial.,"Introduction Some studies have demonstrated that post-PCI elevated cardiac enzymes are associated with worse outcomes. In this study, we aimed to determine if high-dose treatment with atorvastatin before planned elective PCI reduces PMI or MACE at 1-year median follow-up. Material and methods Eligible participants were randomly allocated to group A (80 mg atorvastatin 12 h and 40 mg 2 h before PCI) and group B (40 mg atorvastatin daily). Blood samples were obtained before and at 24 h after PCI to measure hsTnT. All patients were followed regarding MACE (combination of death, re-hospitalizations for ACS, and unplanned coronary revascularization) during one year after PCI. Results 207 patients randomly assigned to Group A (n = 97) or group B (n = 110). The rate of PMI was lower in group A (5.2%) compared to group B (10.9%); despite near to 50% lower rate of PMI in group A, binary logistic regression showed no significant association between atorvastatin recapture and PMI. The occurrence of MACE in 97 patients of group A was 11 (11.3%), higher than 11 (10%) cases of 110 patients in group B. Cox proportional hazards regression model shows no significant difference in MACE of study groups. Conclusion Pretreatment of patients with stable angina who were planned to undergo an elective PCI with 120 mg of atorvastatin before the procedure confer them the same benefit in terms of PMI and MACE as 40 mg routine daily dosage of this statin does.",2019,"The occurrence of MACE in 97 patients of group A was 11 (11.3%), higher than 11 (10%) cases of 110 patients in group B. Cox proportional hazards regression model shows no significant difference in MACE of study groups. ",['patients with stable angina who were planned to undergo an elective PCI with 120\u202fmg of'],"['atorvastatin', 'atorvastatin 12\u202fh and 40\u202fmg 2\u202fh before PCI']","['Blood samples', 'rate of PMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",207.0,0.0383507,"The occurrence of MACE in 97 patients of group A was 11 (11.3%), higher than 11 (10%) cases of 110 patients in group B. Cox proportional hazards regression model shows no significant difference in MACE of study groups. ","[{'ForeName': 'HamidReza', 'Initials': 'H', 'LastName': 'Pourhosseini', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Lashkari', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Danesh', 'Initials': 'D', 'LastName': 'Soltani', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Tehran Heart Center and School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masih', 'Initials': 'M', 'LastName': 'Tajdini', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, North Kargar Ave., Tehran, Iran.'}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2018.12.003'] 337,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC). OBJECTIVE Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC. METHODS A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain. RESULTS Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control). CONCLUSION Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control). ","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control). ","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6'] 338,31838223,Prefrontal but not cerebellar tDCS attenuates renewal of extinguished conditioned eyeblink responses.,"An extended neural network is known to underlie extinction learning. As yet, comparatively little is known about the possible contribution of the cerebellum and the dorsolateral prefrontal cortex (dlPFC). In the present study, transcranial direct current stimulation (tDCS) was used to provide further evidence that the dlPFC and the cerebellum are involved in extinction-related processes. A total of 100 young and healthy human participants were randomly assigned to one of five stimulation groups: (1) anodal tDCS of the cerebellum, (2) cathodal tDCS of the cerebellum, (3) anodal tDCS of the dlPFC, (4) cathodal tDCS of the dlPFC, and (5) sham stimulation. Participants underwent delay eyeblink conditioning using an A-B-A/B renewal paradigm. Two different colors of background light (orange and blue) were used as contexts. On day 1, acquisition of conditioned eyeblink responses was performed in context A, followed by extinction in context B. tDCS was applied during extinction. On day 2, extinction recall was tested in contexts A and B with higher incidence of conditioned responses in acquisition context A compared to extinction context B indicating renewal effects. All groups showed significant effects of acquisition of conditioned eyeblink responses and significant effects of extinction. There was no significant difference in extinction between stimulation groups. During extinction recall, renewal effects were present in all groups, except the group which had received anodal tDCS of the dlPFC during extinction. In the present study, no direct effects of dlPFC or cerebellar tDCS were demonstrated on extinction. Anodal tDCS of the dlPFC, but not the cerebellum, resulted in delayed effects on context-related processes of extinction, possibly explained by shifting attention away from the context and towards the conditioned stimulus during extinction learning. Anodal tDCS of the dlPFC attenuated context-related recall of learned aversive responses. Effects of tDCS, however, were weak and need to be confirmed in future studies. Lack of cerebellar tDCS effects do not exclude a possible role of the cerebellum in extinction-related processes, and are likely explained by methodological limitations of cerebellar tDCS.",2020,"Anodal tDCS of the dlPFC, but not the cerebellum, resulted in delayed effects on context-related processes of extinction, possibly explained by shifting attention away from the context and towards the conditioned stimulus during extinction learning.",['100 young and healthy human participants'],"['anodal tDCS of the cerebellum, 2) cathodal tDCS of the cerebellum, 3) anodal tDCS of the dlPFC, 4) cathodal tDCS of the dlPFC, and 5) sham stimulation', 'tDCS', 'delay eyeblink conditioning using an A-B-A/B renewal paradigm', 'anodal tDCS', 'background light (orange and blue', 'transcranial direct current stimulation (tDCS']","['extinction', 'acquisition of conditioned eyeblink responses']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",100.0,0.0277111,"Anodal tDCS of the dlPFC, but not the cerebellum, resulted in delayed effects on context-related processes of extinction, possibly explained by shifting attention away from the context and towards the conditioned stimulus during extinction learning.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lipp', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Draganova', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Batsikadze', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Ernst', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uengoer', 'Affiliation': 'Department of Psychology, Philipps-University Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Timmann', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany. Electronic address: dagmar.timmann-braun@uni-due.de.'}]",Neurobiology of learning and memory,['10.1016/j.nlm.2019.107137'] 339,32285142,"Aqueous humour concentrations after topical apPlication of combinEd levofloxacin-dexamethasone eye dRops and of its single components: a randoMised, assEssor-blinded, parallel-group study in patients undergoing cataract surgery: the iPERME study.","PURPOSE To evaluate the penetration of levofloxacin and dexamethasone sodium phosphate into the aqueous humour (AH) after administration in combination and as single molecules. Evaluation of the penetration of those agents in the site of action and their pharmacodynamic potential activity in view of the intended clinical use after cataract surgery. METHODS Randomised, assessor-blinded, parallel-group. Patients scheduled for cataract surgery were assigned in a 1:1:1 ratio to: levofloxacin + dexamethasone sodium phosphate (L-DSP), Levofloxacin (L) or Dexamethasone sodium phosphate (DSP) eye drops. Either test or reference drugs were instilled in the cul-de-sac twice, 90 and 60 min before paracentesis. RESULTS A total of 125 patients completed the study. Fraction of dose absorbed in the anterior chamber was 3.8-4.2 · 10 -4 for levofloxacin and 0.3-0.4 · 10 -4 for dexamethasone, respectively. No notable differences in concentration of levofloxacin were found between L-DSP arm (1.970 nmol/ml) and L arm (2.151 nmol/ml). The concentrations of levofloxacin were well above the MICs for the most frequent Gram-positive and Gram-negative eye pathogens. Dexamethasone concentrations were slightly lower in L-DSP arm (0.030 nmol/ml) than in DSP arm (0.042 nmol/ml), but still in the pharmacodynamically active range in the site of action. The difference was not clinically relevant. DSP was not detected in any HA sample, suggesting its full hydrolysis to free dexamethasone. CONCLUSION Our results confirm that no interaction is evident on the corneal penetration of levofloxacin and dexamethasone which reach pharmacologically active concentrations when instilled as fixed combination eye drops to patients undergoing cataract surgery. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03740659.",2020,"Dexamethasone concentrations were slightly lower in L-DSP arm (0.030 nmol/ml) than in DSP arm (0.042 nmol/ml), but still in the pharmacodynamically active range in the site of action.","['Patients scheduled for cataract surgery', 'patients undergoing cataract surgery', '125 patients completed the study']","['levofloxacin and dexamethasone sodium phosphate', 'levofloxacin and dexamethasone', 'levofloxacin-dexamethasone eye dRops', 'levofloxacin', 'levofloxacin + dexamethasone sodium phosphate (L-DSP), Levofloxacin (L) or Dexamethasone sodium phosphate (DSP) eye drops']","['DSP', 'concentration of levofloxacin', 'concentrations of levofloxacin', 'Dexamethasone concentrations']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0304706', 'cui_str': 'Dexamethasone-containing product in ocular dose form'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]",125.0,0.175602,"Dexamethasone concentrations were slightly lower in L-DSP arm (0.030 nmol/ml) than in DSP arm (0.042 nmol/ml), but still in the pharmacodynamically active range in the site of action.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Figus', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, Via Paradisa, 2, 56100, Pisa, Italy. michele.figus@unipi.it.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Posarelli', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, Via Paradisa, 2, 56100, Pisa, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Romano', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Nardi', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, Via Paradisa, 2, 56100, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan, Italy.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02863-7'] 340,32180131,Citicoline and Vitamin B 12 Eye Drops in Type 1 Diabetes: Results of a 3-year Pilot Study Evaluating Morpho-Functional Retinal Changes.,"INTRODUCTION This study aimed to evaluate the effect of treatment with eye drops containing citicoline and vitamin B 12 on changes in function of the inner retina, morphology of the inner and outer retina, and microvascular condition in patients with type 1 diabetes (DM1) with mild signs of non-proliferative diabetic retinopathy (NPDR) during 3 years of follow-up. METHODS A pilot study with prospective, randomized, and double-masked design was conducted to address the aims. Twenty patients with DM1 were enrolled and randomly divided into two groups: the DC group comprising patients treated with citicoline and vitamin B 12 eye drops (10 patients; mean age ± standard deviation, 46.86 ± 8.78 years) and the DP group comprising those treated with placebo (10 patients; mean age ± standard deviation, 47.89 ± 7.74 years). In the DC group, one eye of each patient was treated with citicoline and vitamin B 12 eye drops (OMK2 ® , Omikron Italia srl, Italy, 3 drops/day), while in the DP group, it was treated with placebo (eye drops containing hypromellose 0.3%, 3 drops/day) for a 3-year period. In both groups, Humphrey Matrix frequency doubling technology (FDT), spectral domain optical coherence tomography (SD-OCT) and OCT angiography (OCTA), and adaptive optics (AO) were applied at baseline and 12, 24, and 36 months of the follow-up period. RESULTS In the results of follow-up evaluation, the DC and DP groups were significantly different: Significant reduction in function in terms of 10-2 FDT mean sensitivity and in morphology reflected by an increase in inner nuclear layer thickness and decrease in other plexiform layer thickness and foveal vessel density were observed in the DP group, while no such significant changes were observed in the DC group in the long term. CONCLUSIONS This pilot study indicated that patients with DM1 with mild signs of diabetic retinopathy (DR) who underwent treatment with citicoline and vitamin B 12 eye drops for a 3-year duration achieved stabilization or decreased rate of functional impairment, neuroretinal degeneration, and microvascular damage. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT04009980.",2020,"In the results of follow-up evaluation, the DC and DP groups were significantly different: Significant reduction in function in terms of 10-2 FDT mean sensitivity and in morphology reflected by an increase in inner nuclear layer thickness and decrease in other plexiform layer thickness and foveal vessel density were observed in the DP group, while no such significant changes were observed in the DC group in the long term. ","['patients with type\xa01 diabetes (DM1) with mild signs of non-proliferative diabetic retinopathy (NPDR) during 3\xa0years of follow-up', 'Type\xa01 Diabetes', 'Twenty patients with DM1', 'patients with DM1 with mild signs of diabetic retinopathy (DR) who underwent treatment with']","['eye drops containing citicoline and vitamin\xa0B 12', 'Citicoline and Vitamin\xa0B 12 Eye Drops', 'placebo', 'citicoline and vitamin\xa0B 12 eye drops (OMK2 ® , Omikron Italia srl', 'DC group comprising patients treated with citicoline and vitamin\xa0B 12 eye drops', 'citicoline and vitamin\xa0B 12 eye drops']","['function of the inner retina, morphology of the inner and outer retina, and microvascular condition', 'rate of functional impairment, neuroretinal degeneration, and microvascular damage', 'plexiform layer thickness and foveal vessel density', 'Humphrey Matrix frequency doubling technology (FDT), spectral domain optical coherence tomography (SD-OCT) and OCT angiography (OCTA), and adaptive optics (AO', 'inner nuclear layer thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0004606', 'cui_str': 'NPDR - Non proliferative diabetic retinopathy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0450207', 'cui_str': 'Plexiform (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",20.0,0.112857,"In the results of follow-up evaluation, the DC and DP groups were significantly different: Significant reduction in function in terms of 10-2 FDT mean sensitivity and in morphology reflected by an increase in inner nuclear layer thickness and decrease in other plexiform layer thickness and foveal vessel density were observed in the DP group, while no such significant changes were observed in the DC group in the long term. ","[{'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Parravano', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Scarinci', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy. fabio.scarinci@fondazionebietti.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Parisi', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Giorno', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Giannini', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Oddone', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Varano', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01284-3'] 341,31679945,"Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.","BACKGROUND Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response. METHODS KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at least one dose of allocated treatment). This study is registered at ClinicalTrials.gov, number NCT02358031. FINDINGS Between April 20, 2015, and Jan 17, 2017, 882 participants were allocated to receive pembrolizumab alone (n=301), pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy (n=300); of these, 754 (85%) had CPS of 1 or more and 381 (43%) had CPS of 20 or more. At the second interim analysis, pembrolizumab alone improved overall survival versus cetuximab with chemotherapy in the CPS of 20 or more population (median 14·9 months vs 10·7 months, hazard ratio [HR] 0·61 [95% CI 0·45-0·83], p=0·0007) and CPS of 1 or more population (12·3 vs 10·3, 0·78 [0·64-0·96], p=0·0086) and was non-inferior in the total population (11·6 vs 10·7, 0·85 [0·71-1·03]). Pembrolizumab with chemotherapy improved overall survival versus cetuximab with chemotherapy in the total population (13·0 months vs 10·7 months, HR 0·77 [95% CI 0·63-0·93], p=0·0034) at the second interim analysis and in the CPS of 20 or more population (14·7 vs 11·0, 0·60 [0·45-0·82], p=0·0004) and CPS of 1 or more population (13·6 vs 10·4, 0·65 [0·53-0·80], p<0·0001) at final analysis. Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis. At final analysis, grade 3 or worse all-cause adverse events occurred in 164 (55%) of 300 treated participants in the pembrolizumab alone group, 235 (85%) of 276 in the pembrolizumab with chemotherapy group, and 239 (83%) of 287 in the cetuximab with chemotherapy group. Adverse events led to death in 25 (8%) participants in the pembrolizumab alone group, 32 (12%) in the pembrolizumab with chemotherapy group, and 28 (10%) in the cetuximab with chemotherapy group. INTERPRETATION Based on the observed efficacy and safety, pembrolizumab plus platinum and 5-fluorouracil is an appropriate first-line treatment for recurrent or metastatic HNSCC and pembrolizumab monotherapy is an appropriate first-line treatment for PD-L1-positive recurrent or metastatic HNSCC. FUNDING Merck Sharp & Dohme.",2019,Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis.,"['recurrent or metastatic squamous cell carcinoma of the head and neck', 'head and neck squamous cell carcinoma (HNSCC', '0·65', '0·61', 'Between April 20, 2015, and Jan 17, 2017, 882 participants', 'participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries']","['pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy', 'Pembrolizumab with chemotherapy', 'pembrolizumab', 'pembrolizumab alone', 'Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy', 'pembrolizumab plus platinum and 5-fluorouracil', 'pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy', 'pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy', 'cetuximab with chemotherapy', 'pembrolizumab alone nor pembrolizumab with chemotherapy', 'pembrolizumab with chemotherapy versus cetuximab with chemotherapy']","['adverse events', 'Safety', 'progression-free survival', 'hazard ratio [HR', 'overall survival', 'overall survival (time from randomisation to death from any cause) and progression-free survival', 'overall survival and progression-free survival']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",882.0,0.211751,Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis.,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, USA. Electronic address: barbara.burtness@yale.edu.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust National Institute of Health Research Biomedical Research Centre, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Paracelsus Medical University, Salzburg Cancer Research Institute, Salzburg, Austria; Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Soulières', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Psyrri', 'Affiliation': 'National Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Basté', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Bratland', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Fuereder', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Brett G M', 'Initials': 'BGM', 'LastName': 'Hughes', 'Affiliation': ""Royal Brisbane and Women's Hospital and University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Mesía', 'Affiliation': 'Catalan Institute of Oncology, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Nuttapong', 'Initials': 'N', 'LastName': 'Ngamphaiboon', 'Affiliation': 'Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'University Hospital, Zurich, Switzerland.'}, {'ForeName': 'Wan Zamaniah', 'Initials': 'WZ', 'LastName': 'Wan Ishak', 'Affiliation': 'University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ruey-Long', 'Initials': 'RL', 'LastName': 'Hong', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'González Mendoza', 'Affiliation': 'Unidad de Investigación en Salud, Chihuahua, Mexico.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Yayan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Gumuscu', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Cheng', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Austrialia; University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32591-7'] 342,32285486,The effectiveness of a pressure injury prevention program for nursing assistants in private for-profit nursing homes: A cluster randomized controlled trial.,"AIM To examine the effectiveness of a pressure injury prevention program for private for-profit nursing homes. DESIGN This study was a two-arm cluster randomized controlled trial. Ten private for-profit nursing homes made up the clusters. METHODS The participants were nursing home residents who aged 60 or above regardless of whether or not having pre-existing pressure injuries and also three types of nursing home assistants who provided direct care to the residents from 10 private for-profit nursing homes. These 10 nursing homes were randomly assigned to either the experimental or the control group. There were 477 and 536 resident participants and 51 and 62 nursing assistant participants in the experimental and control groups, respectively. The residents were the study participants and the nursing assistant participants were the interveners. The experimental group had the pressure injury prevention program implemented while the control group received the usual care. The primary study outcome which was the pressure injury incidence was analysed by GEE. Significance was set at a p-value of ≤.05. The data were collected between September 2017-March 2018. RESULT There were significant interactive effects of time and group on the incidence of pressure injuries (p = .0015) and on the skill performance of the nursing assistant participants (p < .0001). CONCLUSIONS An evidence-based pressure injury prevention program reduced the development of the pressure injuries and improved the skill performance of the nursing assistant participants. It is highly recommended that private for-profit nursing homes with high proportion of non-professional nursing assistants and insufficient nurses adopt this program for improving the prevention care of pressure injuries. IMPACT This research has an impact on prevention care of pressure injury in private for-profit nursing homes with high proportion non-professional nursing assistants which have the similar characteristics as the nursing homes studied in various regions and countries. TRIAL REGISTRATION The Controlled Trial registration ID is NCT02270385.",2020,"There were significant interactive effects of time and group on the incidence of pressure injuries (p=0.0015) and on the skill performance of the nursing assistant participants (p<0.0001). ","['Nursing Assistants in Private For-profit Nursing Homes', 'private for-profit nursing homes', 'nursing assistant participants', 'private for-profit nursing homes with high proportion non-professional nursing assistants', 'participants were nursing home residents who aged 60 or above regardless of whether or not having pre-existing pressure injuries and also three types of nursing home assistants who provided direct care to the residents from ten private for-profit nursing homes', 'ten nursing homes', 'There were 477 and 536 resident participants and 51 and 62 nursing assistant participants in the experimental and control groups respectively']","['pressure injury prevention program implemented while the control group received the usual care', 'Pressure Injury Prevention Program', 'pressure injury prevention program']","['skill performance', 'pressure injury incidence', 'incidence of pressure injuries']","[{'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",10.0,0.0327689,"There were significant interactive effects of time and group on the incidence of pressure injuries (p=0.0015) and on the skill performance of the nursing assistant participants (p<0.0001). ","[{'ForeName': 'Enid W-Y', 'Initials': 'EW', 'LastName': 'Kwong', 'Affiliation': 'School of Nursing, Putian University, Putian, Fujian Province, China.'}, {'ForeName': 'Liang Y', 'Initials': 'LY', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Putian University, Putian, Fujian Province, China.'}, {'ForeName': 'Rick Y-C', 'Initials': 'RY', 'LastName': 'Kwan', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}]",Journal of advanced nursing,['10.1111/jan.14391'] 343,31517677,Guiding Opioid Administration by 3 Different Analgesia Nociception Monitoring Indices During General Anesthesia Alters Intraoperative Sufentanil Consumption and Stress Hormone Release: A Randomized Controlled Pilot Study.,"BACKGROUND This pilot study investigated the effect of sufentanil titration by 3 different analgesia monitoring devices or clinical signs during general anesthesia. METHODS Forty-eight patients undergoing radical retropubic prostatectomy with sevoflurane/sufentanil anesthesia were randomly assigned into 4 groups and received sufentanil guided either by 1 of 3 analgesia monitoring devices (Surgical Pleth Index [SPI], Pupillary Pain Index [PPI], Nociception Level [NoL]) or by clinical judgment (control). The primary end point was intraoperative sufentanil consumption. Adrenocorticotropic hormone (ACTH) and cortisol were measured at 4 time points during the day of surgery. Data were analyzed by Kruskal-Wallis and Mann-Whitney U tests and by mixed model and area under the curve (AUC) analyses for group comparisons and time effects of stress hormones. RESULTS The total amount of sufentanil administration (μg·kg·minute·10) differed between the groups (median [quartiles]: control = 5.6 [4.4-6.4], SPI = 7.2 [4.8-8.4], PPI = 2.0 [1.8-2.9], NoL = 3.8 [3.3-5.1]; PPI versus SPI, -5.1 [-6.6 to -1.3], P < .001; NoL versus SPI, -3.0 [-5.2 to 0.2], P = .024; control versus SPI, -1.6 [-3.7 to 1.7], P = .128; NoL versus PPI, 1.7 [0.6-3.4], P < .001; control versus PPI, 3.4 [2.0-4.6], P < .001; control versus NoL, 1.6 [-0.2 to 3.3], P = .017) (Hodges-Lehmann estimator [99% confidence interval {CI}], P values). The AUC analysis indicated differences among groups in cumulative ACTH levels (ng·liter·minute, natural logarithm (ln)-transformed data) of NoL versus PPI (-1.079 [-1.950 to -0.208], P = .001) and PPI versus SPI (1.192 [0.317-2.068], P= .001), as well as differences in cortisol levels (µg·liter·minute) for PPI versus SPI (46,710 [21,145-72,274], P < .001), NoL versus SPI (27,645 [3163-52,126], P = .003), and control versus SPI (31,824 [6974-56,675], P = .001) (differences in means [99% CI], P value). Secondary end points (postoperative recovery, pain level, and analgesia medication) showed no differences. CONCLUSIONS The type of analgesia nociception monitoring affected the total amount of sufentanil administered. Lower sufentanil doses in the PPI group were associated with an increased endocrine stress response. Titration by SPI caused no opioid reduction compared to the control but was associated with a reduced endocrine stress response.",2020,"control versus NoL, 1.6 [-0.2 to 3.3], P = .017)",['Forty-eight patients undergoing'],"['radical retropubic prostatectomy with sevoflurane/sufentanil anesthesia', 'sufentanil guided either by 1 of 3 analgesia monitoring devices (Surgical Pleth Index [SPI], Pupillary Pain Index [PPI], Nociception Level [NoL]) or by clinical judgment (control', 'sufentanil titration']","['endocrine stress response', 'intraoperative sufentanil consumption', 'cortisol levels (µg·liter·minute', 'Adrenocorticotropic hormone (ACTH) and cortisol', 'cumulative ACTH levels (ng·liter·minute, natural logarithm (ln)-transformed data) of NoL versus PPI', 'points (postoperative recovery, pain level, and analgesia medication', 'PPI', 'Intraoperative Sufentanil Consumption and Stress Hormone Release', 'total amount of sufentanil administration (μg·kg·minute·10']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194825', 'cui_str': 'Radical retropubic prostatectomy (procedure)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",48.0,0.142204,"control versus NoL, 1.6 [-0.2 to 3.3], P = .017)","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Funcke', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans O', 'Initials': 'HO', 'LastName': 'Pinnschmidt', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wesseler', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Brinkmann', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Beyer', 'Affiliation': 'Martini-Klinik, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Virginija', 'Initials': 'V', 'LastName': 'Jazbutyte', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph R', 'Initials': 'CR', 'LastName': 'Behem', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Trepte', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Nitzschke', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004388'] 344,31670790,"Local and Systemic Analgesic Effects of Nerve-Specific Acupuncture in Healthy Adults, Measured by Quantitative Sensory Testing.","OBJECTIVE This study aims to assess whether acupuncture analgesia's effects are local or systemic and whether there is a dose response for these effects. METHODS Twenty-eight healthy volunteers aged 18-45 were randomized to two doses of acupuncture using points closely associated with peripheral nerves in the legs. The lower-dose group involved acupoints overlying the deep peroneal nerve (DP), and the higher-dose involved acupoints overlying the deep peroneal and posterior tibial nerves (DPTN). Baseline and acupuncture quantitative sensory testing (QST) assessments were obtained locally in the calf and great toe and systemically in the hand. Results were analyzed using factorial repeated-measures analysis of variance for each of the QST variables-cold detection threshold (CDT), vibration detection threshold (VDT), heat pain threshold (HP0.5), and heat pain perception of 5/10 (HP5.0). Location (leg/hand) and time (baseline/acupuncture) were within-subject factors. Intervention (DP/DPTN) was a between-subject factor. RESULTS CDT was increased in the calf (P < 0.001) and in the hand (P < 0.001). VDT was increased in the toe (P < 0.001) but not in the hand. HP0.5 was increased in the calf (P < 0.001) and in the hand (P < 0.001). HP5.0 was increased in the calf (P = 0.002) and in the hand (P < 0.001), with the local effect being significantly greater than the systemic (P = 0.004). In all of the above QST modalities, there was no difference between the low-dose (DP) and high-dose (DPTN) acupuncture groups. CONCLUSIONS Acupuncture caused comparable local and systemic analgesic effects in cold detection and heat pain perception and only local effects in vibration perception. There was no clear acupuncture dose response to these effects.",2020,"HP5.0 was increased in the calf (P = 0.002) and in the hand (P < 0.001), with the local effect being significantly greater than the systemic (P = 0.004).","['Healthy Adults', 'Twenty-eight healthy volunteers aged 18-45']","['acupuncture analgesia', 'Nerve-Specific Acupuncture', 'acupuncture', 'Acupuncture']","['Location (leg/hand) and time (baseline/acupuncture', 'HP5.0', 'VDT', 'QST variables-cold detection threshold (CDT), vibration detection threshold (VDT), heat pain threshold (HP0.5), and heat pain perception']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001300', 'cui_str': 'Acupuncture Analgesia'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}]",28.0,0.108897,"HP5.0 was increased in the calf (P = 0.002) and in the hand (P < 0.001), with the local effect being significantly greater than the systemic (P = 0.004).","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dimitrova', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Dana Dharmakaya', 'Initials': 'DD', 'LastName': 'Colgan', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz276'] 345,31675621,Pharmacokinetic interaction of brivaracetam on other antiepileptic drugs in adults with focal seizures: Pooled analysis of data from randomized clinical trials.,"OBJECTIVE To assess the effect of brivaracetam (BRV) on steady-state plasma concentrations of commonly prescribed antiepileptic drugs (AEDs). METHODS Data were pooled from five randomized, double-blind, placebo-controlled efficacy studies (NCT00175929, NCT00175825, NCT00490035, NCT00464269, and NCT01261325) in which adults with refractory epilepsy, and receiving stable doses of 1-2 AEDs, initiated adjunctive treatment with BRV (or placebo) for up to 12 weeks, following a 4-8 week baseline period. Concentrations of carbamazepine, carbamazepine epoxide, clobazam, clonazepam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine (MHD), phenobarbital, phenytoin, pregabalin, topiramate, valproic acid and zonisamide, were measured during baseline and during BRV or placebo evaluation periods. Log-transformed data for patients receiving BRV dosages of 50-200 mg/day (or placebo) were evaluated using repeated measures analysis of covariance. Geometric least-squares means ratios of respective AED concentrations (treatment vs baseline) and their 90% confidence intervals (CIs) were calculated. Relevant interaction of BRV on the respective AED was inferred if CIs were entirely outside of 0.80-1.25 limits. RESULTS Within the population for analysis (n = 1402), relevant interaction was observed for carbamazepine epoxide alone which increased up to 2-fold from baseline due to inhibition of epoxide hydrolase by BRV, and the effect size was not influenced by concomitant valproic acid. Relevant interaction was not observed for other AEDs. CONCLUSION In adults with focal seizures, adjunctive BRV treatment does not affect plasma concentrations of the evaluated AEDs but increases carbamazepine epoxide metabolite. Carbamazepine dose reduction should be considered if tolerability issues arise.",2019,"In adults with focal seizures, adjunctive BRV treatment does not affect plasma concentrations of the evaluated AEDs but increases carbamazepine epoxide metabolite.","['adults with focal seizures', 'adults with refractory epilepsy, and receiving stable doses of 1-2 AEDs, initiated adjunctive treatment with']","['carbamazepine, carbamazepine epoxide, clobazam, clonazepam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine (MHD), phenobarbital, phenytoin, pregabalin, topiramate, valproic acid and zonisamide', 'BRV (or placebo', 'placebo', 'brivaracetam', 'Carbamazepine', 'brivaracetam (BRV']",['Geometric least-squares means ratios of respective AED concentrations'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory Epilepsy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0054640', 'cui_str': 'carbamazepine epoxide'}, {'cui': 'C0055891', 'cui_str': 'clobazam'}, {'cui': 'C0009011', 'cui_str': 'Clonazepam'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0042291', 'cui_str': 'Valproic Acid'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}]","[{'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",1402.0,0.770245,"In adults with focal seizures, adjunctive BRV treatment does not affect plasma concentrations of the evaluated AEDs but increases carbamazepine epoxide metabolite.","[{'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Moseley', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otoul', 'Affiliation': ""UCB Pharma, Braine-l'Alleud, Belgium.""}, {'ForeName': 'Ludovicus', 'Initials': 'L', 'LastName': 'Staelens', 'Affiliation': ""UCB Pharma, Braine-l'Alleud, Belgium.""}, {'ForeName': 'Armel', 'Initials': 'A', 'LastName': 'Stockis', 'Affiliation': ""UCB Pharma, Braine-l'Alleud, Belgium. Electronic address: armel.stockis@ucb.com.""}]",Epilepsy research,['10.1016/j.eplepsyres.2019.106218'] 346,32121016,"Sensory Acceptance, Appetite Control and Gastrointestinal Tolerance of Yogurts Containing Coffee-Cascara Extract and Inulin.","The improvement of the nutritional quality of dairy foods has become a key strategy for reducing the risk of developing diet-related non-communicable diseases. In this context, we aimed to optimize the concentration of inulin in combination with 10 mg/mL of coffee-cascara extract in yogurt while considering their effect on appetite control, gastrointestinal wellbeing, and their effect on the sensory and technological properties of the product. For this purpose, we tested four coffee-cascara yogurt treatments in a blind cross-over nutritional trial with 45 healthy adults: a coffee-cascara yogurt without inulin (Y0) and coffee-cascara yogurts containing 3% (Y3), 7% (Y7), and 13% (Y13) of inulin. The ratings on sensory acceptance, satiety, gastrointestinal tolerance, and stool frequency were measured. Surveys were carried out digitally in each participant's cellphone. Yogurt pH, titratable acidity, syneresis, and instrumental texture were analyzed. Inulin addition increased the yogurt's firmness and consistency. Y13 achieved significantly higher overall acceptance, texture, and taste scores than Y0 ( p < 0.05 ). Y3 presented similar gastrointestinal tolerance to Y0. However, 7% and 13% of inulin produced significant ( p < 0.05 ) bloating and flatulence when compared to Y0. The appetite ratings were not significantly affected by the acute intake of the different yogurts. Overall, Y3 was identified as the formulation that maximized nutritional wellbeing, reaching a ""source of fiber"" nutritional claim, without compromising its technological and sensory properties.",2020,"Y13 achieved significantly higher overall acceptance, texture, and taste scores than Y0 ( p < 0.05 ).",['45 healthy adults'],"['inulin in combination with 10 mg/mL of coffee-cascara extract', 'Yogurts Containing Coffee-Cascara Extract and Inulin', 'coffee-cascara yogurt treatments', 'coffee-cascara yogurt without inulin (Y0) and coffee-cascara yogurts']","['bloating and flatulence', 'overall acceptance, texture, and taste scores', 'Sensory Acceptance, Appetite Control and Gastrointestinal Tolerance', 'gastrointestinal tolerance', 'Yogurt pH, titratable acidity, syneresis, and instrumental texture', 'appetite control, gastrointestinal wellbeing', 'sensory acceptance, satiety, gastrointestinal tolerance, and stool frequency', 'appetite ratings']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0205704', 'cui_str': 'cascara'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0003622', 'cui_str': 'Appetite Regulation'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0368606', 'cui_str': 'Titratable acidity (observable entity)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",45.0,0.0195922,"Y13 achieved significantly higher overall acceptance, texture, and taste scores than Y0 ( p < 0.05 ).","[{'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Iriondo-DeHond', 'Affiliation': 'Instituto Madrileño de Investigación y Desarrollo Rural, Agrario y Alimentario (IMIDRA), N-II km 38,200, 28800 Alcalá de Henares, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Iriondo-DeHond', 'Affiliation': 'Instituto de Investigación en Ciencias de la Alimentación (CIAL) (UAM-CSIC), C/ Nicolás Cabrera, 9, Campus de la Universidad Autónoma de Madrid, 28049 Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Herrera', 'Affiliation': 'Instituto de Investigación en Ciencias de la Alimentación (CIAL) (UAM-CSIC), C/ Nicolás Cabrera, 9, Campus de la Universidad Autónoma de Madrid, 28049 Madrid, Spain.'}, {'ForeName': 'Adriana Maite', 'Initials': 'AM', 'LastName': 'Fernández-Fernández', 'Affiliation': 'Departamento de Ciencia y Tecnología de Alimentos, Facultad de Química, Universidad de la República, General Flores 2124, Montevideo 11800, Uruguay.'}, {'ForeName': 'Carlos Oscar S', 'Initials': 'COS', 'LastName': 'Sorzano', 'Affiliation': 'Centro Nacional de Biotecnología (CNB-CSIC), C/ Darwin, 3, 28049 Madrid, Spain.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Miguel', 'Affiliation': 'Instituto Madrileño de Investigación y Desarrollo Rural, Agrario y Alimentario (IMIDRA), N-II km 38,200, 28800 Alcalá de Henares, Spain.'}, {'ForeName': 'María Dolores Del', 'Initials': 'MDD', 'LastName': 'Castillo', 'Affiliation': 'Instituto de Investigación en Ciencias de la Alimentación (CIAL) (UAM-CSIC), C/ Nicolás Cabrera, 9, Campus de la Universidad Autónoma de Madrid, 28049 Madrid, Spain.'}]",Nutrients,['10.3390/nu12030627'] 347,32289853,"A prospective, randomized trial of thrombin versus cyanoacrylate injection in the control of acute gastric variceal hemorrhage.","BACKGROUND Acute gastric variceal hemorrhage (AGVH) is a serious complication of portal hypertension. Endoscopic cyanoacrylate glue injection is standard therapy for acute hemostasis; however, it may be associated with serious complications. The role of thrombin injection has not been confirmed. This study compared endoscopic thrombin and glue injections in the hemostasis of AGVH. METHODS 68 eligible patients with AGVH were randomized to receive thrombin injection (33 patients) or glue injection (35 patients). The primary end point was injection-induced gastric ulcers. Secondary end points were acute hemostasis, rebleeding, and mortality within 42 days. RESULTS Both groups had comparable baseline data. Hemostasis of active bleeding at endoscopy was 90.0 % (9/10) in the thrombin group and 90.9 % (10/11) in the glue group ( P  = 0.58), and 48-hour hemostasis was achieved in 93.9 % (31/33) and 97.1 % (34/35), respectively ( P  = 0.60). Treatment failure at 5 days occurred in two patients (6.1 %) in the thrombin group and two patients (5.7 %) in the glue group ( P  > 0.99). Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P  < 0.001, 95 % confidence interval [CI] 8 % - 27 %). Complications occurred in 4 (12.1 %) and 18 (51.4 %) patients in the thrombin and glue groups, respectively ( P  < 0.001, 95 %CI 22 % - 45 %). Two patients who received glue had post-treatment gastric ulcer bleeding. One patient in each group died. CONCLUSIONS Endoscopic thrombin injection was similar to glue injection in achieving successful hemostasis of AGVH. However, a higher incidence of complications may be associated with glue injection.",2020,"Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P  < 0.001, 95 % confidence interval [CI] 8 % - 27 %).","['acute gastric variceal hemorrhage', 'acute hemostasis', 'Acute gastric variceal hemorrhage (AGVH', 'Two patients who received glue had post-treatment gastric ulcer bleeding', '68 eligible patients with AGVH']","['glue injection', 'cyanoacrylate injection', 'thrombin', 'Endoscopic cyanoacrylate glue injection', 'Endoscopic thrombin injection', 'endoscopic thrombin and glue injections', 'thrombin injection']","['Treatment failure', '48-hour hemostasis', 'acute hemostasis, rebleeding, and mortality within 42 days', 'Complications', 'Gastric ulcers', 'injection-induced gastric ulcers', 'Hemostasis of active bleeding at endoscopy']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0333106', 'cui_str': 'Bleeding varices'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}]","[{'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",68.0,0.126385,"Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P  < 0.001, 95 % confidence interval [CI] 8 % - 27 %).","[{'ForeName': 'Gin-Ho', 'Initials': 'GH', 'LastName': 'Lo', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chih-Wen', 'Initials': 'CW', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chi-Ming', 'Initials': 'CM', 'LastName': 'Tai', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Daw-Shyong', 'Initials': 'DS', 'LastName': 'Perng', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'I-Lin', 'Initials': 'IL', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Jen-Hao', 'Initials': 'JH', 'LastName': 'Yeh', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}]",Endoscopy,['10.1055/a-1127-3170'] 348,32252062,"Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.","A single, subanesthetic dose of (R,S)-ketamine (ketamine) exerts rapid and robust antidepressant effects. Several groups previously reported that (2S,6S;2R,6R)-hydroxynorketamine (HNK) had antidepressant effects in rodents, and that (2R,6R)-HNK increased cortical electroencephalographic gamma power. This exploratory study examined the relationship between ketamine metabolites, clinical response, psychotomimetic symptoms, and gamma power changes in 34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a single ketamine infusion (0.5 mg/kg) over 40 min. Plasma concentrations of ketamine, norketamine, and HNKs were measured at 40, 80, 120, and 230 min and at 1, 2, and 3 days post-infusion. Linear mixed models evaluated ketamine metabolites as mediators of antidepressant and psychotomimetic effects and their relationship to resting-state whole-brain magnetoencephalography (MEG) gamma power 6-9 h post-infusion. Three salient findings emerged. First, ketamine concentration positively predicted distal antidepressant response at Day 11 post-infusion, and an inverse relationship was observed between (2S,6S;2R,6R)-HNK concentration and antidepressant response at 3 and 7 days post-infusion. Norketamine concentration was not associated with antidepressant response. Second, ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations at 40 min were positively associated with contemporaneous psychotomimetic symptoms; post-hoc analysis revealed that ketamine was the predominant contributor. Third, increased (2S,6S;2R,6R)-HNK maximum observed concentration (C max ) was associated with increased MEG gamma power. While contrary to preclinical observations and our a priori hypotheses, these exploratory results replicate those of a recently published study documenting a relationship between higher (2S,6S;2R,6R)-HNK concentrations and weaker antidepressant response in humans and provide further rationale for studying gamma power changes as potential biomarkers of antidepressant response.",2020,Norketamine concentration was not associated with antidepressant response.,['34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a'],"['placebo', 'ketamine', 'subanesthetic dose of (R,S)-ketamine (ketamine', '2S,6S;2R,6R)-hydroxynorketamine (HNK', 'Ketamine', 'single ketamine infusion']","['Plasma concentrations of ketamine, norketamine, and HNKs', '2S,6S;2R,6R)-HNK concentration and antidepressant response', 'ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations', 'distal antidepressant response', 'Norketamine concentration', 'cortical electroencephalographic gamma power']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0410552,Norketamine concentration was not associated with antidepressant response.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0663-6'] 349,32167976,Effects of Inhaled Iloprost on Lung Mechanics and Myocardial Function During One-Lung Ventilation in Chronic Obstructive Pulmonary Disease Patients Combined With Poor Lung Oxygenation.,"BACKGROUND The ventilation/perfusion mismatch in chronic obstructive pulmonary disease (COPD) patients can exacerbate cardiac function as well as pulmonary oxygenation. We hypothesized that inhaled iloprost can ameliorate pulmonary oxygenation with lung mechanics and myocardial function during one-lung ventilation (OLV) in COPD patients combined with poor lung oxygenation. METHODS A total of 40 patients with moderate to severe COPD, who exhibited the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FIO2) <150 mm Hg 30 minutes after initiating OLV, were enrolled in this study. Patients were randomly allocated into either ILO group (n = 20) or Control group (n = 20), in which iloprost (20 μg) and saline were inhaled, respectively. The PaO2/FIO2 ratio, dead space, dynamic compliance, and tissue Doppler imaging with myocardial performance index (MPI) were assessed 30 minutes after initiating OLV (pre-Tx) and 30 minutes after completion of drug inhalation (post-Tx). Repeated variables were analyzed using a linear mixed-model between the groups. RESULTS At pre-Tx, no differences were observed in measured parameters between the groups. At post-Tx, PaO2/FIO2 ratio (P < .001) and dynamic compliance (P = .023) were significantly higher and dead space ventilation was significantly lower (P = .001) in iloprost group (ILO group) compared to Control group. Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group. CONCLUSIONS Inhaled iloprost improved pulmonary oxygenation, lung mechanics, and cardiac function simultaneously during OLV in COPD patients with poor lung oxygenation.",2020,"Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group. ","['COPD patients combined with poor lung oxygenation', 'COPD patients with poor lung oxygenation', 'chronic obstructive pulmonary disease (COPD) patients', '40 patients with moderate to severe COPD, who exhibited the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FIO2) <150 mm', 'Chronic Obstructive Pulmonary Disease Patients Combined With Poor Lung Oxygenation', 'Hg 30 minutes after initiating OLV']","['ILO', 'iloprost', 'Inhaled Iloprost', 'inhaled iloprost', 'Inhaled iloprost', 'iloprost (20 μg) and saline']","['Lung Mechanics and Myocardial Function', 'right ventricular MPIs', 'pulmonary oxygenation, lung mechanics, and cardiac function simultaneously', 'pulmonary oxygenation with lung mechanics and myocardial function', 'PaO2/FIO2 ratio', 'PaO2/FIO2 ratio, dead space, dynamic compliance, and tissue Doppler imaging with myocardial performance index (MPI', 'dead space ventilation', 'dynamic compliance']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}]","[{'cui': 'C0079594', 'cui_str': 'Iloprost'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",40.0,0.0179437,"Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group. ","[{'ForeName': 'Namo', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei Sarang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Joe', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Taelim', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heesoo', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Oh', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004733'] 350,32284323,Metabolic Disorders with Kidney Transplant.,"Metabolic disorders are highly prevalent in kidney transplant candidates and recipients and can adversely affect post-transplant graft outcomes. Management of diabetes, hyperparathyroidism, and obesity presents distinct opportunities to optimize patients both before and after transplant as well as the ability to track objective data over time to assess a patient's ability to partner effectively with the health care team and adhere to complex treatment regimens. Optimization of these particular disorders can most dramatically decrease the risk of surgical and cardiovascular complications post-transplant. Approximately 60% of nondiabetic patients experience hyperglycemia in the immediate post-transplant phase. Multiple risk factors have been identified related to development of new onset diabetes after transplant, and it is estimated that upward of 7%-30% of patients will develop new onset diabetes within the first year post-transplant. There are a number of medications studied in the kidney transplant population for diabetes management, and recent data and the risks and benefits of each regimen should be optimized. Secondary hyperparathyroidism occurs in most patients with CKD and can persist after kidney transplant in up to 66% of patients, despite an initial decrease in parathyroid hormone levels. Parathyroidectomy and medical management are the options for treatment of secondary hyperparathyroidism, but there is no randomized, controlled trial providing clear recommendations for optimal management, and patient-specific factors should be considered. Obesity is the most common metabolic disorder affecting the transplant population in both the pre- and post-transplant phases of care. Not only does obesity have associations and interactions with comorbid illnesses, such as diabetes, dyslipidemia, and cardiovascular disease, all of which increase morbidity and mortality post-transplant, but it also is intimately inter-related with access to transplantation for patients with kidney failure. We review these metabolic disorders and their management, including data in patients with kidney transplants.",2020,Obesity is the most common metabolic disorder affecting the transplant population in both the pre- and post-transplant phases of care.,"['Metabolic Disorders with Kidney Transplant', 'patients with kidney failure', 'patients with kidney transplants']",[],['parathyroid hormone levels'],"[{'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}]",[],"[{'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}]",,0.0213202,Obesity is the most common metabolic disorder affecting the transplant population in both the pre- and post-transplant phases of care.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cohen', 'Affiliation': 'Department of Pharmacy, Yale-New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Korah', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Callender', 'Affiliation': 'Department of Surgery, Section of Endocrine Surgery, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Belfort de Aguiar', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Haakinson', 'Affiliation': 'Department of Surgery, Section of Transplant, Yale University, New Haven, Connecticut danielle.haakinson@yale.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.09310819'] 351,32284380,"Safety, Pharmacokinetics, and Drug-Drug Interaction Potential of Intravenous Durlobactam, a β-Lactamase Inhibitor, in Healthy Subjects.","Durlobactam (DUR; also known as ETX2514) is a novel β-lactamase inhibitor with broad activity against Ambler class A, C, and D β-lactamases. Addition of DUR to sulbactam (SUL) in vitro restores SUL activity against clinical isolates of Acinetobacter baumannii The safety and pharmacokinetics (PK) of DUR alone and with SUL and/or imipenem-cilastatin (IMI-CIL) were evaluated in healthy subjects. This was a randomized, placebo-controlled study. In part A, subjects, including a cohort of elderly subjects (which received DUR at 1 g), received single ascending doses of DUR ranging from 0.25 to 8 g. In part B, multiple ascending doses of DUR ranging from 0.25 to 2 g were administered every 6 h (q6h) for 29 doses. In parts C and D, the drug-drug interaction (DDI) potential, including the safety, of DUR (1 g) with SUL (1 g) and/or IMI-CIL (0.5/0.5 g) was investigated after single and multiple doses. Plasma and urine concentrations of DUR, SUL, and IMI-CIL were determined. Among 124 subjects, DUR was generally safe and well tolerated when it was administered either alone or in combination with SUL and/or IMI-CIL. After single and multiple doses, DUR demonstrated linear dose-proportional exposure across the studied dose ranges. Renal excretion was a predominant clearance mechanism. No drug-drug interaction potential between DUR and SUL and/or IMI-CIL was identified. SUL-DUR at 1 g (of each component) administered q6h with a 3-h intravenous (i.v.) infusion is under development for the treatment of serious infections due to A. baumannii (This study has been registered at ClinicalTrials.gov under identifier NCT02971423.).",2020,"Among 124 subjects, DUR was generally safe and well tolerated either alone or in combination with SUL and/or IMI/CIL.","['124 subjects', 'Healthy Subjects', 'healthy subjects']","['SUL and/or imipenem/cilastatin (IMI/CIL', 'placebo', 'single ascending doses of DUR 0.25-8 g']","['safe and well tolerated', 'Renal excretion', 'Plasma and urine concentrations of DUR, SUL, and IMI/CIL']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0008777', 'cui_str': 'Cilastatin'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0164683', 'cui_str': 'Cilest'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1318217', 'cui_str': '8G'}]","[{'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0164683', 'cui_str': 'Cilest'}]",124.0,0.0285004,"Among 124 subjects, DUR was generally safe and well tolerated either alone or in combination with SUL and/or IMI/CIL.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lawrence', 'Affiliation': 'Tetraphase Pharmaceuticals, Watertown, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Donnell"", 'Affiliation': 'Entasis Therapeutics, Inc., Waltham, Massachusetts, USA John.odonnell@entasistx.com.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Isaacs', 'Affiliation': 'Entasis Therapeutics, Inc., Waltham, Massachusetts, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00071-20'] 352,32284384,"Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis).","Gepotidacin, a triazaacenaphthylene bacterial type II topoisomerase inhibitor, is in development for treatment of uncomplicated urinary tract infection (uUTI). This phase 2a study in female participants with uUTI evaluated the pharmacokinetics (primary objective), safety, and exploratory efficacy of gepotidacin. Eligible participants ( n  = 22) were confined to the clinic at baseline, received oral gepotidacin at 1,500 mg twice daily for 5 days (on-therapy period; days 1 to 5), and returned to the clinic for test-of-cure (days 10 to 13) and follow-up (day 28 ± 3) visits. Pharmacokinetic, safety, clinical, and microbiological assessments were performed. Maximum plasma concentrations were observed approximately 1.5 to 2 h postdose. Steady state was attained by day 3. Urinary exposure over the dosing interval increased from 3,742 μg·h/ml (day 1) to 5,973 μg·h/ml (day 4), with trough concentrations of 322 to 352 μg/ml from day 3 onward. Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends. Clinical success was achieved in 19 (86%) and 18 (82%) of 22 participants at test-of-cure and follow-up visits, respectively. Eight participants had a qualifying baseline uropathogen (growth; ≥10 5 CFU/ml). A therapeutic (combined clinical and microbiological [no growth; <10 3 CFU/ml]) successful response was achieved in 6 (75%) and 5 (63%) of 8 participants at test-of-cure and follow-up visits, respectively. Plasma area under the free-drug concentration-time curve over 24 h at steady state divided by the MIC ( f AUC 0-24 /MIC) and urine AUC 0-24 /MIC ranged from 6.99 to 90.5 and 1,292 to 121,698, respectively. Further evaluation of gepotidacin in uUTI is warranted. (This study has been registered in ClinicalTrials.gov under identifier NCT03568942.).",2020,Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends.,"['Eight participants had a qualifying baseline uropathogen (growth; ≥10 5 CFU/ml', 'Eligible participants (N = 22', 'female participants with uUTI', 'Female Participants With Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis']","['oral gepotidacin', 'Oral Gepotidacin (GSK2140944', 'urine AUC 0-24 /MIC']","['successful response', 'Pharmacokinetic, safety, clinical, and microbiological assessments', 'Maximum plasma concentrations', 'Plasma area under the free-drug concentration-time curve', 'Clinical success']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4309999', 'cui_str': 'gepotidacin'}, {'cui': 'C4310555', 'cui_str': 'GSK2140944'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",22.0,0.0764344,Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends.,"[{'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Overcash', 'Affiliation': 'eStudySite, La Mesa, California, USA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Tiffany', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Scangarella-Oman', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Perry', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA Caroline.R.Perry@gsk.com Etienne.F.Dumont@gsk.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Barth', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Etienne F', 'Initials': 'EF', 'LastName': 'Dumont', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA Caroline.R.Perry@gsk.com Etienne.F.Dumont@gsk.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00199-20'] 353,31377190,Comparison of Rest to Aerobic Exercise and Placebo-like Treatment of Acute Sport-Related Concussion in Male and Female Adolescents.,"OBJECTIVE To compare a sample of adolescents with sport-related concussion (SRC) who were prescribed rest with 2 arms of a randomized controlled trial comparing aerobic exercise with placebo-like stretching. We also compared sex differences across the 3 approaches to treatment. DESIGN Quasi-experimental trial. SETTING University concussion management clinics. PARTICIPANTS Adolescent athletes (aged 13-18 years) presenting within 10 days of SRC (mean, 5 days after injury) received a recommendation for rest (rest group [RG], n=48, 15.4±1y, 25% female). Their outcomes were compared with matched samples of adolescents assigned to aerobic exercise (exercise group [EG], n=52, 15.3±2y, 46% female) or placebo-like stretching (placebo group [PG], n=51, 15.4±2y, 47% female) (N=151). MAIN OUTCOME MEASURES The primary outcome was median days from injury to recovery. The secondary outcome was proportion classified as normal recovery (<30d) or delayed recovery (≥30d). RESULTS The RG recovered in 16 days (interquartile range, 9.25-23.25d), which was significantly delayed (P=.020) compared with EG (13d; interquartile range, 10-18.5d). The PG recovered in 17 days (interquartile range, 13-23d). Four percent of the EG, 14% of the PG, and 13% of the RG had delayed recovery (P=.190). There was no difference in recovery time or delayed recovery between male participants and female participants across groups. Female participants prescribed rest experienced an increase in symptoms vs the other groups (P=.013). CONCLUSION Relative rest and a placebo-like stretching program were very similar in days to recovery and symptom improvement pattern after SRC. Both conditions were less effective than subsymptom threshold aerobic exercise. Female adolescents appear to be susceptible to symptom increase when prescribed rest.",2019,"Female participants prescribed rest experienced an increase in symptoms vs the other groups (P=.013). ","['Female adolescents', 'adolescents with sport-related concussion (SRC', 'Adolescent athletes (aged 13-18 years) presenting within 10 days of SRC (mean, 5 days after injury) received a recommendation for rest (rest group [RG], n=48, 15.4±1y, 25% female', 'Acute Sport-Related Concussion in Male and Female Adolescents', 'University concussion management clinics', 'group [PG], n=51, 15.4±2y, 47% female) (N=151', 'male participants and female participants across groups']","['aerobic exercise with placebo-like stretching', 'aerobic exercise (exercise group [EG', 'placebo-like stretching (placebo', 'placebo-like stretching program', 'Rest to Aerobic Exercise and Placebo-like Treatment']","['proportion classified as normal recovery (<30d) or delayed recovery (≥30d', 'median days from injury to recovery', 'recovery time or delayed recovery', 'delayed recovery', 'RG']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.694695,"Female participants prescribed rest experienced an increase in symptoms vs the other groups (P=.013). ","[{'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Willer', 'Affiliation': 'Department of Psychiatry, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States. Electronic address: bswiller@buffalo.edu.'}, {'ForeName': 'Mohammad N', 'Initials': 'MN', 'LastName': 'Haider', 'Affiliation': 'UBMD Department of Orthopaedics and Sports Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States; PhD Program in Biomedical Science, Neuroscience, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Bezherano', 'Affiliation': 'Department of Nutrition and Exercise Science, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Wilber', 'Affiliation': 'UBMD Department of Orthopaedics and Sports Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Mannix', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts, United States.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kozlowski', 'Affiliation': 'Department of Nutrition and Exercise Science, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Leddy', 'Affiliation': 'UBMD Department of Orthopaedics and Sports Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.07.003'] 354,31773873,Cost-Effectiveness of a Weight Loss Intervention: An Adaptation of the Look AHEAD Lifestyle Intervention in the US Military.,"OBJECTIVE This study aimed to assess whether a counselor-initiated (CI) adaptation of the Look AHEAD (Action for Health in Diabetes) intensive lifestyle intervention in a military setting was cost-effective relative to a self-paced (SP) adaptation. METHODS A cost-effectiveness analysis from a payer perspective was performed alongside a 2014-2017 randomized behavioral weight loss trial among 248 active-duty military personnel stationed at a US Air Force base in Texas. Incremental cost-effectiveness ratios were calculated for weight loss, reductions in waist circumference, and quality-adjusted life-years (QALYs). RESULTS After 12 months, the CI adaptation cost more per participant compared with the SP adaptation ($1,081 vs. $120) but achieved greater weight loss (1.86 kg vs. 0.06 kg), greater reductions in waist circumference (1.85 cm vs. 0.48 cm), and more QALYs (0.871 vs. 0.856). The incremental cost-effectiveness ratio for the CI adaptation relative to the SP adaptation was $61,268 per additional QALY. At willingness-to-pay thresholds of $50,000 and $100,000 per QALY, the CI adaptation was 45% and 49% likely to be cost-effective, respectively. CONCLUSIONS The CI delivery of the Look AHEAD Intensive Lifestyle Intervention may offer a cost-effective approach to tackle excess weight in the US military.",2020,"Incremental cost-effectiveness ratios were calculated for weight loss, reductions in waist circumference, and quality-adjusted life-years (QALYs). ",['2014-2017 randomized behavioral weight loss trial among 248 active-duty military personnel stationed at a US Air Force base in Texas'],"['counselor-initiated (CI) adaptation of the Look AHEAD (Action for Health in Diabetes) intensive lifestyle intervention', 'Weight Loss Intervention']","['incremental cost-effectiveness ratio for the CI adaptation relative to the SP adaptation', 'Incremental cost-effectiveness ratios', 'SP adaptation', 'CI adaptation', 'weight loss, reductions in waist circumference, and quality-adjusted life-years (QALYs', 'weight loss', 'waist circumference', 'CI adaptation cost']","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",2017.0,0.0511607,"Incremental cost-effectiveness ratios were calculated for weight loss, reductions in waist circumference, and quality-adjusted life-years (QALYs). ","[{'ForeName': 'Karina C', 'Initials': 'KC', 'LastName': 'Manz', 'Affiliation': 'Department of Health Management and Policy, College of Public Health, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Waters', 'Affiliation': 'Department of Health Management and Policy, College of Public Health, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Clifton', 'Affiliation': 'Department of Health Management and Policy, College of Public Health, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22681'] 355,30920339,Combining CDP-choline and galantamine: Effects of a selective α7 nicotinic acetylcholine receptor agonist strategy on P50 sensory gating of speech sounds in healthy volunteers.,"BACKGROUND Schizophrenia (SCZ) patients and relatives have deficits in early cortical sensory gating (SG) typically measured by suppression of electroencephalography-derived P50 event-related potentials (ERPs) in a conditioning-testing (S 1 -S 2 ) paradigm. Associated with alpha 7 nicotinic acetylcholine receptor (α7 nAChR) dysfunction and shown to be improved with nicotine and α7 nAChR agonists, SG has recently been shown to be improved in low P50 suppressing SCZ patients following acute CDP-choline treatment. AIMS This pilot study in healthy humans assessed the SG effects of an α7 nAChR strategy combining CDP-choline with galantamine, a positive allosteric modulator (PAM) of nAChRs, aimed at increasing and prolonging nicotinic receptor activity. METHODS The combined effect of CDP-choline (500 mg) and galantamine (16 mg) on speech P50 gating indices rP50 (S 2 /S 1 ) and dP50 (S 1 -S 2 ) was examined in 30 healthy participants stratified into low and high baseline P50 suppressors in a randomized, double-blind, placebo-controlled and counterbalanced design. RESULTS In low suppressors, CDP-choline/galantamine (vs. placebo) improved rP50 and dP50 gating, and reduced S 2 P50 amplitudes. No P50 gating effects were observed in high suppressors; however, CDP-choline/galantamine (vs. placebo) increased their S 2 P50 amplitudes. CONCLUSION Findings from this pilot study with CDP-choline/galantamine in a healthy, SCZ-like surrogate deficient gating sample are consistent with the association of α7 nAChR mechanisms in SG impairment in SCZ and support further research trials with CDP-choline and galantamine targeting sensory processes.",2019,"In low suppressors, CDP-choline/galantamine (vs. placebo) improved rP50 and dP50 gating, and reduced S 2 P50 amplitudes.","['healthy humans', 'healthy volunteers', 'low P50 suppressing SCZ patients following acute CDP-choline treatment', '30 healthy participants stratified into low and high baseline P50 suppressors']","['CDP-choline/galantamine', 'galantamine', 'CDP-choline', 'placebo-controlled and counterbalanced design', 'CDP-choline/galantamine (vs. placebo', 'dP50']","['P50 sensory gating of speech sounds', 'rP50 and dP50 gating, and reduced S 2 P50 amplitudes', 'speech P50 gating indices rP50']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0219874', 'cui_str': 'tyrosine protein kinase p50csk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0219874', 'cui_str': 'tyrosine protein kinase p50csk'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0037829', 'cui_str': 'Speech Sounds'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2722359', 'cui_str': 'S-2'}, {'cui': 'C0429405', 'cui_str': 'P50 amplitude (observable entity)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.113125,"In low suppressors, CDP-choline/galantamine (vs. placebo) improved rP50 and dP50 gating, and reduced S 2 P50 amplitudes.","[{'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Choueiry', 'Affiliation': '1 Department of Neuroscience, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Blais', 'Affiliation': '2 Institute of Cognitive Science, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Dhrasti', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': '3 School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': '3 School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': '4 Department of Psychology, Faculty of Social Sciences, Mount Saint Vincent University, Halifax, NS, Canada.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Illivitsky', 'Affiliation': '5 The Royal Ottawa Mental Health Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Verner', 'Initials': 'V', 'LastName': 'Knott', 'Affiliation': '1 Department of Neuroscience, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119836217'] 356,32101663,Pembrolizumab for Early Triple-Negative Breast Cancer.,"BACKGROUND Previous trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative breast cancer. Whether the addition of pembrolizumab to neoadjuvant chemotherapy would significantly increase the percentage of patients with early triple-negative breast cancer who have a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery is unclear. METHODS In this phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with previously untreated stage II or stage III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) every 3 weeks plus paclitaxel and carboplatin (784 patients; the pembrolizumab-chemotherapy group) or placebo every 3 weeks plus paclitaxel and carboplatin (390 patients; the placebo-chemotherapy group); the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, the patients received adjuvant pembrolizumab or placebo every 3 weeks for up to nine cycles. The primary end points were a pathological complete response at the time of definitive surgery and event-free survival in the intention-to-treat population. RESULTS At the first interim analysis, among the first 602 patients who underwent randomization, the percentage of patients with a pathological complete response was 64.8% (95% confidence interval [CI], 59.9 to 69.5) in the pembrolizumab-chemotherapy group and 51.2% (95% CI, 44.1 to 58.3) in the placebo-chemotherapy group (estimated treatment difference, 13.6 percentage points; 95% CI, 5.4 to 21.8; P<0.001). After a median follow-up of 15.5 months (range, 2.7 to 25.0), 58 of 784 patients (7.4%) in the pembrolizumab-chemotherapy group and 46 of 390 patients (11.8%) in the placebo-chemotherapy group had disease progression that precluded definitive surgery, had local or distant recurrence or a second primary tumor, or died from any cause (hazard ratio, 0.63; 95% CI, 0.43 to 0.93). Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively. CONCLUSIONS Among patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy. (Funded by Merck Sharp & Dohme [a subsidiary of Merck]; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488.).",2020,"Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively. ","['patients with early triple-negative breast cancer', 'Early Triple-Negative Breast Cancer', '2:1 ratio) patients with previously untreated stage II or stage III triple-negative breast cancer to receive']","['neoadjuvant therapy with four cycles of pembrolizumab', 'placebo plus neoadjuvant chemotherapy', 'adjuvant pembrolizumab or placebo', 'doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide', 'pembrolizumab', 'placebo-chemotherapy', 'pembrolizumab or placebo', 'pembrolizumab plus neoadjuvant chemotherapy', 'Pembrolizumab', 'pembrolizumab to neoadjuvant chemotherapy', 'paclitaxel and carboplatin', 'pembrolizumab-chemotherapy group) or placebo', 'pembrolizumab-chemotherapy']","['incidence of treatment-related adverse events', 'pathological complete response at the time of definitive surgery and event-free survival', 'death', 'local or distant recurrence', 'pathological complete response', 'disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",,0.636498,"Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively. ","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McArthur', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Liyi', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Karantza', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Gursel', 'Initials': 'G', 'LastName': 'Aktan', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dent', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1910549'] 357,32291095,"A randomized half-body, double blind, controlled trial on the effects of a pH-modified moisturizer vs. standard moisturizer in mild to moderate atopic dermatitis.","BACKGROUND Higher skin pH in atopic dermatitis contributes to impaired epidermal barrier. A moisturizer compatible with physiological pH could improve atopic dermatitis. OBJECTIVE To determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis. METHODS A randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks. RESULTS A total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p=0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p=0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p=0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p=0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p=0.046). SCORAD improved from 14.1±12.75 to 10.5±13.25 to 7±12.25, p=0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p=0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p=0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p=0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p=0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p=0.80). SCORAD improved from 14.2±9.1 to 10.9±10.65 to 10.5±11, p=0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer. STUDY LIMITATION Skin hydration was not evaluated. CONCLUSION Moisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.",2020,"pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer. ","['patients with stable atopic dermatitis', 'atopic dermatitis', 'mild to moderate atopic dermatitis', 'A total of 6 (16.7%) males and 30 (83.3%) females participated']","['Moisturization', 'pH-modified moisturizer vs. standard moisturizer', 'pH-modified moisturizer and standard moisturizer']","['greater pH, TEWL and SCORAD improvements', 'Reduction in pH', 'pH reductions', 'SCORAD', 'atopic dermatitis', 'Transepidermal water loss (TEWL', 'Skin pH reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0232445', 'cui_str': 'Acid mantle'}]",,0.11098,"pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer. ","[{'ForeName': 'Siew Wen', 'Initials': 'SW', 'LastName': 'Goh', 'Affiliation': 'Dermatology Unit, Medical Department, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Adawiyah', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia. Electronic address: adda_jamil@yahoo.com.'}, {'ForeName': 'Nazarudin', 'Initials': 'N', 'LastName': 'Safian', 'Affiliation': 'Department of Community Health, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norazirah', 'Initials': 'N', 'LastName': 'Md Nor', 'Affiliation': 'Dermatology Unit, Medical Department, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norliza', 'Initials': 'N', 'LastName': 'Muhammad', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nur Liyana', 'Initials': 'NL', 'LastName': 'Saharudin', 'Affiliation': 'Department of Pharmacy, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}]",Anais brasileiros de dermatologia,['10.1016/j.abd.2019.11.007'] 358,32265361,"Early Progression and Immune Reconstitution Inflammatory Syndrome During Treatment of Mild-To-Moderate Kaposi Sarcoma in Sub-Saharan Africa and South America: Incidence, Long-Term Outcomes, and Effects of Early Chemotherapy.","BACKGROUND Early progression of AIDS-associated Kaposi sarcoma (KS-PD) and immune reconstitution inflammatory syndrome (KS-IRIS) sometimes occur after the initiation of antiretroviral therapy (ART). METHODS Early KS-PD and KS-IRIS were assessed in the A5264/AMC-067 trial in which participants with mild-to-moderate AIDS-KS were randomized to initiate ART with either immediate or as-needed oral etoposide. Early KS-PD was defined as tumor progression within 12 weeks of ART initiation. When investigators had concern that early KS-PD was KS-IRIS, additional evaluations were performed. Suspected KS-IRIS was defined as early KS-PD accompanied by a CD4 count increase of ≥50 cells per cubic millimeter or plasma HIV-1 RNA decrease of ≥0.5 log10 copies/mL. Clinical outcome was a composite end point categorized as failure, stable, and response at 48 and 96 weeks compared with baseline. RESULTS Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS and 22 were not evaluated for KS-IRIS. Early KS-PD and KS-IRIS incidences with immediate etoposide versus ART alone were 16% versus 39%, and 7% versus 21%, respectively. Week 48 clinical outcome was 45% failure, 18% stable, and 37% response for no early KS-PD; 82% failure, 2% stable, and 16% response for early KS-PD; and 88% failure, 0% stable, and 12% response for KS-IRIS. Cumulative incidence of KS tumor response by week 96 was 64% for no early KS-PD, 22% with early KS-PD, and 18% with KS-IRIS. CONCLUSIONS Early KS-PD, including suspected KS-IRIS, was common after starting ART for AIDS-KS and was associated with worse long-term clinical outcomes. Starting ART concurrently with etoposide reduced the incidence of both early KS-PD and KS-IRIS compared with ART alone.",2020,Week 48 clinical outcome was 45%,"['mild-to-moderate Kaposi sarcoma in sub-Saharan Africa and South America', 'Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS, 22 were not evaluated for KS-IRIS', 'participants with mild-to-moderate AIDS-KS']","['immediate etoposide', 'early chemotherapy', 'etoposide']","['incidence of both early KS-PD and KS-IRIS', 'Early KS-PD and KS-IRIS incidences', 'Early KS-PD and KS-IRIS', 'Cumulative incidence of KS tumor response', 'plasma HIV-1']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0036220', 'cui_str': ""Kaposi's sarcoma""}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",,0.10907,Week 48 clinical outcome was 45%,"[{'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'McNeil', 'Initials': 'M', 'LastName': 'Ngongondo', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Umbleja', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Krown', 'Affiliation': 'AIDS Malignancy Consortium, New York, NY.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International Clinical Research Site, Enhancing Care Foundation, Durban, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Hoagland', 'Affiliation': 'Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Frontier Science Foundation, Amherst, New York, NY.'}, {'ForeName': 'Oto', 'Initials': 'O', 'LastName': 'Martinez-Maza', 'Affiliation': 'Department of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, CA.'}, {'ForeName': 'Dirk P', 'Initials': 'DP', 'LastName': 'Dittmer', 'Affiliation': 'Department of Microbiology & Immunology, University of North Carolina School of Medicine, and Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Borok', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002361'] 359,32157626,Evaluation of Nurse Preferences Between the Lanreotide Autogel New Syringe and the Octreotide Long-Acting Release Syringe: An International Simulated-Use Study (PRESTO).,"INTRODUCTION Somatostatin analogues are used to treat symptoms and slow tumour progression in patients with neuroendocrine tumours (NETs) and carcinoid syndrome and to reduce hormone secretion and pituitary tumour volume in patients with acromegaly. A new syringe for lanreotide autogel/depot (LAN) was developed following feedback from a human factors study to improve ease of injection compared with previous syringes. PRESTO aimed to assess preferences of nurses between the LAN new syringe and the octreotide long-acting release (LAR) syringe. METHODS PRESTO, a multinational, multicentre, prospective, noninterventional, simulated-use study, enrolled nurses with ≥ 2 years' experience injecting LAN and/or octreotide LAR in patients with NETs and/or acromegaly. Nurses administered injections into pads using the LAN new syringe and octreotide LAR syringe in a randomised sequence. In an anonymous web-based questionnaire, nurses reported their overall preference ('strong' or 'slight'; primary endpoint) and rated and ranked the importance of nine attributes for each syringe (1 [not at all] to 5 [very much]). RESULTS Overall, 90 nurses attended sessions and completed valid questionnaires. Most nurses (97.8%) expressed a preference (85.6% 'strong', 12.2% 'slight') for the LAN new syringe versus the octreotide LAR syringe (P < 0.0001). Attribute performance ratings (1 [not at all] to 5 [very much]) were consistently higher for the LAN new syringe versus the octreotide LAR syringe, with the greatest differences in 'fast administration' and 'confidence the syringe will not be clogged' (mean difference [SD]: 2.6 [1.2] and 2.3 [1.5], respectively; P < 0.0001). The attribute ranked most important was 'confidence the syringe will not be clogged' (24.4%); least important was 'convenience of syringe format, including packaging, from preparation to injection' (34.4%). CONCLUSIONS Nurses preferred the user experience of the LAN new syringe compared with the octreotide LAR syringe, with a particular preference for attributes related to product delivery with the LAN new syringe.",2020,"The attribute ranked most important was 'confidence the syringe will not be clogged' (24.4%); least important was 'convenience of syringe format, including packaging, from preparation to injection' (34.4%). ","['enrolled nurses with\u2009≥', 'patients with NETs and/or acromegaly', 'patients with neuroendocrine tumours (NETs) and carcinoid syndrome']","['lanreotide autogel/depot (LAN', 'octreotide LAR syringe', 'octreotide LAR', 'Lanreotide Autogel New Syringe and the Octreotide Long-Acting Release Syringe', 'octreotide long-acting release (LAR) syringe', 'LAN']",['Attribute performance ratings'],"[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001206', 'cui_str': 'Somatotropin Hypersecretion Syndrome (Acromegaly)'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0024586', 'cui_str': 'Malignant Carcinoid Syndrome'}]","[{'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}]",90.0,0.0348636,"The attribute ranked most important was 'confidence the syringe will not be clogged' (24.4%); least important was 'convenience of syringe format, including packaging, from preparation to injection' (34.4%). ","[{'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Adelman', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. d-adelman@northwestern.edu.'}, {'ForeName': 'Xuan-Mai', 'Initials': 'XM', 'LastName': 'Truong Thanh', 'Affiliation': 'Global Medical Affairs, Ipsen, Boulogne-Billancourt, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Feuilly', 'Affiliation': 'Health Economics and Outcomes Research, Ipsen, Boulogne-Billancourt, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Houchard', 'Affiliation': 'Biometry, Ipsen, Boulogne-Billancourt, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Advances in therapy,['10.1007/s12325-020-01255-8'] 360,32166538,Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2.,"INTRODUCTION New open-angle glaucoma (OAG) and ocular hypertension (OHT) therapies that reduce treatment burden and improve outcomes relative to currently available agents are needed. Netarsudil, a novel Rho kinase inhibitor approved by the US Food and Drug Administration, reduces intraocular pressure (IOP) by increasing trabecular outflow. Two phase 3 superiority studies compared a fixed-dose combination (FDC) of netarsudil and the prostaglandin latanoprost with each active component for IOP-lowering efficacy. METHODS Pooled efficacy and safety data were analyzed from MERCURY-1 and -2 studies in patients with OAG or OHT. Patients instilled one drop of netarsudil (0.02%)/latanoprost (0.005%) FDC (n = 483), netarsudil (0.02%, n = 499), or latanoprost (0.005%, n = 486) into each eye once-daily between 20:00 and 22:00. IOP was measured at 08:00, 10:00, and 16:00 at weeks 2, 6, and the primary endpoint at month 3. RESULTS Baseline mean diurnal IOP was 23.6, 23.6, and 23.5 mmHg in netarsudil/latanoprost FDC, netarsudil, and latanoprost groups, respectively. Mean diurnal IOP in each group was 15.3, 18.1, and 17.5 mmHg at week 2, 15.7, 18.4, and 17.4 mmHg at week 6, and 15.8, 18.4, and 17.3 mmHg at week 12. The netarsudil/latanoprost FDC met criteria for superiority compared with each active component (p < 0.0001 for all nine time points). At month 3, among patients randomized to netarsudil/latanoprost FDC or latanoprost, 58.4% vs 37.3% (p < 0.0001) achieved IOP ≤ 16 mmHg. Among patients randomized to netarsudil/latanoprost FDC or netarsudil or latanoprost, 30.9% vs 5.9% (p < 0.0001) vs 8.5% (p < 0.0001) achieved at least a 40% reduction from baseline in mean diurnal IOP. Pooled safety results were consistent with individual MERCURY studies. CONCLUSION Once-daily netarsudil/latanoprost FDC produced statistically significant and clinically relevant reductions in mean IOP that were statistically superior to IOP reductions achieved by netarsudil and latanoprost monotherapy. Results of the pooled efficacy and safety analyses were consistent with the individual studies. TRIAL REGISTRATION ClinicalTrials.gov identifiers, NCT02558400 and NCT02674854.",2020,FDC met criteria for superiority compared with each active component (p < 0.0001 for all nine time points).,"['Ocular Hypertension and Open-Angle Glaucoma', 'patients with OAG or OHT']","['latanoprost', 'Netarsudil and Latanoprost', 'netarsudil/latanoprost FDC or latanoprost', 'fixed-dose combination (FDC) of netarsudil and the prostaglandin latanoprost', 'netarsudil/latanoprost FDC or netarsudil or latanoprost']","['Mean diurnal IOP', 'intraocular pressure (IOP', 'Baseline mean diurnal IOP', 'IOP', 'IOP reductions']","[{'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.164725,FDC met criteria for superiority compared with each active component (p < 0.0001 for all nine time points).,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Asrani', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA. sanjay.asrani@duke.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bacharach', 'Affiliation': 'North Bay Eye Associates, Petaluma, CA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Holland', 'Affiliation': 'Cincinnati Eye Institute, Cincinnati, OH, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'McKee', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Casey C', 'Initials': 'CC', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Durham, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01277-2'] 361,32241780,A Post Hoc Analysis of Statin Use in Tolvaptan Autosomal Dominant Polycystic Kidney Disease Pivotal Trials.,"BACKGROUND AND OBJECTIVES Tolvaptan is approved to slow kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. Because in vitro studies indicated that the tolvaptan oxobutyric acid metabolite inhibits organic anion-transporting polypeptide (OATP)1B1 and OATP1B3, United States prescribing information advises avoiding concurrent use with OATP1B1/1B3 substrates, including hepatic hydroxymethyl glutaryl-CoA reductase inhibitors (statins). This post hoc analysis of the pivotal phase 3 tolvaptan trials (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes [TEMPO] 3:4 trial [NCT00428948] and Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD [REPRISE] trial [NCT02160145]) examined the safety of concurrent tolvaptan/statin use. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS The trials randomized a combined total of 2815 subjects with early- to late-stage ADPKD to tolvaptan ( n =1644) or placebo ( n =1171) for 3 years (TEMPO 3:4) and 1 year (REPRISE). Statin use was unrestricted, and 597 subjects (21.2% overall; 332 [20.2%] tolvaptan, 265 [22.6%] placebo) received statins. Statin use (duration, dose change, statin change, permanent discontinuation), incidences of statin-related adverse events, and hepatic transaminase elevations were determined for subjects who received tolvaptan+statin, placebo+statin, tolvaptan alone, and placebo alone. RESULTS No differences in statin use parameters between tolvaptan- and placebo-treated subjects were observed. No statistically significant increases in commonly reported statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms) were seen between subjects receiving tolvaptan+statin and placebo+statin. For example, in TEMPO 3:4, frequencies were 5.4% and 7.8%, respectively, for myalgia (difference -2.4%; 95% confidence interval, -11.2% to 6.4%) and 9.3% and 7.8%, respectively, for abdominal pain (difference 1.5%; -7.9% to 10.9%). In an analysis that excluded participants concurrently using allopurinol, the frequency of alanine transaminase or aspartate transaminase >3× upper limit of normal in the pooled study populations was 3.6% for the tolvaptan+statin group and 2.3% for the placebo+statin group (difference 1.4%; -2.0% to 4.7%). CONCLUSIONS Tolvaptan has been used safely in combination with statins in clinical trials. PODCAST This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_04_06_CJN.08170719.mp3.",2020,"No statistically significant increases in commonly reported statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms) were seen between subjects receiving tolvaptan+statin and placebo+statin.","['2815 subjects with early- to late-stage ADPKD to tolvaptan ( n =1644) or', 'adults with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression', ' n =1171) for 3 years (TEMPO 3:4) and 1 year (REPRISE']","['tolvaptan- and placebo', 'placebo+statin', 'tolvaptan+statin, placebo+statin, tolvaptan alone, and placebo', 'placebo', 'allopurinol', 'Tolvaptan']","['myalgia', 'statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms', 'Statin use (duration, dose change, statin change, permanent discontinuation), incidences of statin-related adverse events, and hepatic transaminase elevations', 'frequency of alanine transaminase or aspartate transaminase >3× upper limit of normal', 'abdominal pain']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",2815.0,0.269788,"No statistically significant increases in commonly reported statin-related adverse events ( e.g. , musculoskeletal disorders, gastrointestinal symptoms) were seen between subjects receiving tolvaptan+statin and placebo+statin.","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Shoaf', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland susan.shoaf@otsuka-us.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sergeyeva', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Estilo', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Leung', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.08170719'] 362,32235930,Effects of underfeeding and oral vancomycin on gut microbiome and nutrient absorption in humans.,"Direct evidence in humans for the impact of the microbiome on nutrient absorption is lacking. We conducted an extended inpatient study using two interventions that we hypothesized would alter the gut microbiome and nutrient absorption. In each, stool calorie loss, a direct proxy of nutrient absorption, was measured. The first phase was a randomized cross-over dietary intervention in which all participants underwent in random order 3 d of over- and underfeeding. The second was a randomized, double-blind, placebo-controlled pharmacologic intervention using oral vancomycin or matching placebo (NCT02037295). Twenty-seven volunteers (17 men and 10 women, age 35.1 ± 7.3, BMI 32.3 ± 8.0), who were healthy other than having impaired glucose tolerance and obesity, were enrolled and 25 completed the entire trial. The primary endpoints were the effects of dietary and pharmacological intervention on stool calorie loss. We hypothesized that stool calories expressed as percentage of caloric intake would increase with underfeeding compared with overfeeding and increase during oral vancomycin treatment. Both primary endpoints were met. Greater stool calorie loss was observed during underfeeding relative to overfeeding and during vancomycin treatment compared with placebo. Key secondary endpoints were to evaluate the changes in gut microbial community structure as evidenced by amplicon sequencing and metagenomics. We observed only a modest perturbation of gut microbial community structure with under- versus overfeeding but a more widespread change in community structure with reduced diversity with oral vancomycin. Increase in Akkermansia muciniphila was common to both interventions that resulted in greater stool calorie loss. These results indicate that nutrient absorption is sensitive to environmental perturbations and support the translational relevance of preclinical models demonstrating a possible causal role for the gut microbiome in dietary energy harvest.",2020,Greater stool calorie loss was observed during underfeeding relative to overfeeding and during vancomycin treatment compared with placebo.,"['humans', 'Twenty-seven volunteers (17 men and 10 women, age 35.1\u2009±\u20097.3, BMI 32.3\u2009±\u20098.0), who were healthy other than having impaired glucose tolerance and obesity, were enrolled and 25 completed the entire trial']","['placebo', 'underfeeding and oral vancomycin', 'dietary and pharmacological intervention', 'vancomycin or matching placebo', 'vancomycin', 'dietary intervention']","['gut microbiome and nutrient absorption', 'gut microbial community structure as evidenced by amplicon sequencing and metagenomics', 'stool calorie loss', 'caloric intake']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C4704957', 'cui_str': 'Microbial Community Structure'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",27.0,0.138031,Greater stool calorie loss was observed during underfeeding relative to overfeeding and during vancomycin treatment compared with placebo.,"[{'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Basolo', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA. alessio.basolo@nih.gov.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Hohenadel', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Qi Yan', 'Initials': 'QY', 'LastName': 'Ang', 'Affiliation': 'Department of Microbiology and Immunology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Heinitz', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Core Laboratory, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'Clinical Mass Spectrometry Core, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Parrington', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Donovan D', 'Initials': 'DD', 'LastName': 'Trinidad', 'Affiliation': 'Department of Microbiology and Immunology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Reiner Jumpertz', 'Initials': 'RJ', 'LastName': 'von Schwartzenberg', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Turnbaugh', 'Affiliation': 'Department of Microbiology and Immunology, University of California, San Francisco, CA, USA. peter.turnbaugh@ucsf.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA. jkrakoff@mail.nih.gov.'}]",Nature medicine,['10.1038/s41591-020-0801-z'] 363,31767473,A randomised assessment of image guided radiotherapy within a phase 3 trial of conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer.,"BACKGROUND AND PURPOSE Image-guided radiotherapy (IGRT) improves treatment set-up accuracy and provides the opportunity to reduce target volume margins. We introduced IGRT methods using standard (IGRT-S) or reduced (IGRT-R) margins in a randomised phase 2 substudy within CHHiP trial. We present a pre-planned analysis of the impact of IGRT on dosimetry and acute/late pelvic side effects using gastrointestinal and genitourinary clinician and patient-reported outcomes (PRO) and evaluate efficacy. MATERIALS AND METHODS CHHiP is a randomised phase 3, non-inferiority trial for men with localised prostate cancer. 3216 patients were randomly assigned to conventional (74 Gy in 2 Gy/fraction (f) daily) or moderate hypofractionation (60 or 57 Gy in 3 Gy/f daily) between October 2002 and June 2011. The IGRT substudy included a second randomisation assigning to no-IGRT, IGRT-S (standard CTV-PTV margins), or IGRT-R (reduced CTV-PTV margins). Primary substudy endpoint was late RTOG bowel and urinary toxicity at 2 years post-radiotherapy. RESULTS Between June 2010 to July 2011, 293 men were recruited from 16 centres. Median follow-up is 56.9(IQR 54.3-60.9) months. Rectal and bladder dose-volume and surface percentages were significantly lower in IGRT-R compared to IGRT-S group; (p < 0.0001). Cumulative proportion with RTOG grade ≥ 2 toxicity reported to 2 years for bowel was 8.3(95% CI 3.2-20.7)%, 8.3(4.7-14.6)% and 5.8(2.6-12.4)% and for urinary 8.4(3.2-20.8)%, 4.6(2.1-9.9)% and 3.9(1.5-9.9)% in no IGRT, IGRT-S and IGRT-R groups respectively. In an exploratory analysis, treatment efficacy appeared similar in all three groups. CONCLUSION Introduction of IGRT was feasible in a national randomised trial and IGRT-R produced dosimetric benefits. Overall side effect profiles were acceptable in all groups but lowest with IGRT and reduced margins. ISRCTN 97182923.",2020,Rectal and bladder dose-volume and surface percentages were significantly lower in IGRT-R compared to IGRT-S group; (p < 0.0001).,"['men with localised prostate cancer', '3216 patients', 'prostate cancer', 'Between June 2010 to July 2011, 293 men were recruited from 16 centres']","['image guided radiotherapy', 'conventional or hypofractionated high dose intensity modulated radiotherapy', 'conventional (74\u202fGy in 2\u202fGy/fraction (f) daily) or moderate hypofractionation', 'IGRT', 'IGRT methods using standard (IGRT-S) or reduced (IGRT-R) margins', 'guided radiotherapy (IGRT']","['Cumulative proportion with RTOG grade\u202f≥\u202f2 toxicity', 'late RTOG bowel and urinary toxicity', 'Overall side effect profiles', 'no-IGRT, IGRT-S (standard CTV-PTV margins), or IGRT-R (reduced CTV-PTV margins', 'Rectal and bladder dose-volume and surface percentages']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C3179062', 'cui_str': 'Image-Guided Radiation Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",3216.0,0.159942,Rectal and bladder dose-volume and surface percentages were significantly lower in IGRT-R compared to IGRT-S group; (p < 0.0001).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'The Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gulliford', 'Affiliation': 'The Institute of Cancer Research, London, UK; Department of Radiotherapy, University College London Hospitals NHS Foundation Trust, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Cardiff University/Velindre Cancer Centre, UK.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Panades', 'Affiliation': 'Lincoln County Hospital, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Scrase', 'Affiliation': 'Ipswich Hospital, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'The Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'The Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Dean', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mayles', 'Affiliation': 'Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mayles', 'Affiliation': 'Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mossop', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cruickshank', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dearnaley', 'Affiliation': 'The Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK. Electronic address: david.dearnaley@icr.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.10.017'] 364,31785830,"Synchronous versus sequential chemo-radiotherapy in patients with early stage breast cancer (SECRAB): A randomised, phase III, trial.","BACKGROUND The optimal sequence of adjuvant chemotherapy and radiotherapy for breast cancer is unknown. SECRAB assesses whether local control can be improved without increased toxicity. METHODS SECRAB was a prospective, open-label, multi-centre, phase III trial comparing synchronous to sequential chemo-radiotherapy, conducted in 48 UK centres. Patients with invasive, early stage breast cancer were eligible. Randomisation (performed using random permuted block assignment) was stratified by centre, axillary surgery, chemotherapy, and radiotherapy boost. Permitted chemotherapy regimens included CMF and anthracycline-CMF. Synchronous radiotherapy was administered between cycles two and three for CMF or five and six for anthracycline-CMF. Sequential radiotherapy was delivered on chemotherapy completion. Radiotherapy schedules included 40 Gy/15F over three weeks, and 50 Gy/25F over five weeks. The primary outcome was local recurrence at five and ten years, defined as time to local recurrence, and analysed by intention to treat. ClinicalTrials.gov NCT00003893. FINDINGS Between 02-July-1998 and 25-March-2004, 2297 patients were recruited (1150 synchronous and 1146 sequential). Baseline characteristics were balanced. With 10.2 years median follow-up, the ten-year local recurrence rates were 4.6% and 7.1% in the synchronous and sequential arms respectively (hazard ratio (HR) 0.62; 95% confidence interval (CI): 0.43-0.90; p = 0.012). In a planned sub-group analysis of anthracycline-CMF, the ten-year local recurrence rates difference were 3.5% versus 6.7% respectively (HR 0.48 95% CI: 0.26-0.88; p = 0.018). There was no significant difference in overall or disease-free survival. 24% of patients on the synchronous arm suffered moderate/severe acute skin reactions compared to 15% on the sequential arm (p < 0.0001). There were no significant differences in late adverse effects apart from telangiectasia (p = 0.03). INTERPRETATION Synchronous chemo-radiotherapy significantly improved local recurrence rates. This was delivered with an acceptable increase in acute toxicity. The greatest benefit of synchronous chemo-radiation was in patients treated with anthracycline-CMF. FUNDING Cancer Research UK (CR UK/98/001) and Pharmacia.",2020,24% of patients on the synchronous arm suffered moderate/severe acute skin reactions compared to 15% on the sequential arm (p < 0.0001).,"['patients with early stage breast cancer (SECRAB', 'Patients with invasive, early stage breast cancer were eligible', '2297 patients were recruited (1150 synchronous and 1146 sequential', '48 UK centres']","['adjuvant chemotherapy and radiotherapy', 'axillary surgery, chemotherapy, and radiotherapy boost', 'sequential chemo-radiotherapy', 'anthracycline-CMF', 'Synchronous radiotherapy', 'CMF and anthracycline-CMF', '25-March-2004', 'Synchronous versus sequential chemo-radiotherapy', 'Sequential radiotherapy']","['time to local recurrence, and analysed by intention to treat', 'local recurrence', 'acute toxicity', 'moderate/severe acute skin reactions', 'late adverse effects apart from telangiectasia', 'local recurrence rates', 'overall or disease-free survival', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",2297.0,0.372281,24% of patients on the synchronous arm suffered moderate/severe acute skin reactions compared to 15% on the sequential arm (p < 0.0001).,"[{'ForeName': 'Indrajit N', 'Initials': 'IN', 'LastName': 'Fernando', 'Affiliation': 'Cancer Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom. Electronic address: Indrajit.Fernando@uhb.nhs.uk.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Bowden', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, United Kingdom.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Herring', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, United Kingdom.'}, {'ForeName': 'Cassandra L', 'Initials': 'CL', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester General Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Ikhlaaq', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'Oncology Unit, University Hospitals Coventry and Warwickshire NHS Trust, University Hospital, Coventry, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Churn', 'Affiliation': 'Clinical Oncology, Worcestershire Royal Hospital, Worcester, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spooner', 'Affiliation': 'Cancer Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Talaat N', 'Initials': 'TN', 'LastName': 'Latief', 'Affiliation': 'Cancer Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Rajiv K', 'Initials': 'RK', 'LastName': 'Agrawal', 'Affiliation': 'The Shrewsbury and Telford NHS Trust, Royal Shrewsbury Hospital, Shrewsbury, United Kingdom.'}, {'ForeName': 'Adrian M', 'Initials': 'AM', 'LastName': 'Brunt', 'Affiliation': 'Cancer Centre, Royal Stoke University Hospital & Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': 'Cancer Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Oncology Unit, Torbay and South Devon NHS Foundation Trust, Torbay Hospital, Torquay, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Canney', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'North Wales Cancer Treatment Centre, Glan Clwyd Hospital, United Kingdom.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ritchie', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Poole', 'Affiliation': 'Oncology Unit, University Hospitals Coventry and Warwickshire NHS Trust, University Hospital, Coventry, United Kingdom.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Rea', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.10.014'] 365,30991399,Stable Ozonides with Vitamin E Acetate versus Corticosteroid in the Treatment of Lichen Sclerosus in Foreskin: Evaluation of Effects on Inflammation.,"BACKGROUND Lichen sclerosus (LS) is a disease of the skin of unclear etiology that can occur in the foreskin. Topical therapy with corticosteroids is recommended, but they can have side effects. OBJECTIVES We aimed to compare the effects of ozonides with vitamin E acetate (OZOILE) versus topical corticosteroid in children undergoing circumcision. METHOD Twenty children undergoing circumcision were treated before surgery: 10 children with OZOILE cream and 10 with 0.1% mometasone furoate once a day for 7 days. Ten age-matched patients with LS of the foreskin without any treatment were recruited as controls. Transcript levels of proinflammatory and anti-inflammatory cytokines and e-cadherin were evaluated in removed foreskins by qRT-PCR. RESULTS OZOILE and steroid topical treatment produced a similar reduction of TNF-α and IL-1β mRNA levels in foreskins from patients with LS when compared to untreated patients (p < 0.001). OZOILE and steroid treatment caused an increase in the transcript levels of IL-13 and e-cadherin in the foreskin of patients affected by LS in comparison to untreated foreskin (p < 0.001). CONCLUSIONS On the basis of our biochemical data, a randomized clinical trial might be useful to verify the actual clinical effect of OZOILE as alternative treatment to corticosteroids in children affected by LS of the foreskin.",2019,"RESULTS OZOILE and steroid topical treatment produced a similar reduction of TNF-α and IL-1β mRNA levels in foreskins from patients with LS when compared to untreated patients (p < 0.001).","['children undergoing circumcision', 'children affected by LS of the foreskin', 'Twenty children undergoing circumcision were treated before surgery: 10 children with', 'Lichen Sclerosus in Foreskin', 'Ten age-matched patients with LS of the foreskin without any treatment were recruited as controls']","['Vitamin E Acetate versus Corticosteroid', 'ozonides with vitamin E acetate (OZOILE) versus topical corticosteroid', 'OZOILE cream and 10 with 0.1% mometasone furoate']","['TNF-α and IL-1β mRNA levels', 'transcript levels of IL-13 and e-cadherin', 'Transcript levels of proinflammatory and anti-inflammatory cytokines and e-cadherin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0227952', 'cui_str': 'Foreskin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0023652', 'cui_str': 'Lichen Sclerosus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0078373', 'cui_str': 'Tocopherol Acetate'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1721382', 'cui_str': 'ozonide'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0042172', 'cui_str': 'Cadherin-1'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",20.0,0.072152,"RESULTS OZOILE and steroid topical treatment produced a similar reduction of TNF-α and IL-1β mRNA levels in foreskins from patients with LS when compared to untreated patients (p < 0.001).","[{'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Russo', 'Affiliation': 'Department of Human Pathology of Adult and Childhood ""Gaetano Barresi"", Pediatric Surgery Unit- University of Messina, Messina, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Currò', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ferlazzo', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Caccamo', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Perrone', 'Affiliation': 'Department of Human Pathology of Adult and Childhood ""Gaetano Barresi"", Pediatric Surgery Unit- University of Messina, Messina, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Arena', 'Affiliation': 'Department of Human Pathology of Adult and Childhood ""Gaetano Barresi"", Pediatric Surgery Unit- University of Messina, Messina, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Antonelli', 'Affiliation': 'Department of Human Pathology of Adult and Childhood ""Gaetano Barresi"", Pediatric Surgery Unit- University of Messina, Messina, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Antonuccio', 'Affiliation': 'Department of Human Pathology of Adult and Childhood ""Gaetano Barresi"", Pediatric Surgery Unit- University of Messina, Messina, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Ientile', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Romeo', 'Affiliation': 'Department of Human Pathology of Adult and Childhood ""Gaetano Barresi"", Pediatric Surgery Unit- University of Messina, Messina, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Impellizzeri', 'Affiliation': 'Department of Human Pathology of Adult and Childhood ""Gaetano Barresi"", Pediatric Surgery Unit- University of Messina, Messina, Italy, impellizzerip@unime.it.'}]",Urologia internationalis,['10.1159/000499846'] 366,32289804,A Single Motivational Lecture Can Promote Modest Weight Loss: A Randomized Controlled Trial.,"BACKGROUND Obesity is a public health problem worldwide. To widely disseminate weight-loss interventions across the target population, a cost-effective approach is needed. OBJECTIVE We aimed to test whether a single motivational lecture could promote weight loss. METHODS Our study was a 3-month randomized controlled trial, and we recruited participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan, and randomly assigned them to a control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h. No other lectures or textbooks were provided. The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome. The primary outcome was body weight change at 3 months. RESULTS We enrolled 145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2. The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively. The between-group difference was 1.83 kg (95% CI 1.15-2.51). CONCLUSIONS The significant difference suggested that a single motivational lecture is an effective option to promote modest weight loss in the short term.",2020,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","['participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan', '145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2', 'The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome']","['Motivational Lecture', 'control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h', 'single motivational lecture']","['body weight change at 3 months', 'Modest Weight Loss', 'weight loss', '3-month body weight change']","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",145.0,0.202298,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","[{'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan, nakata.yoshio.gn@u.tsukuba.ac.jp.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'Faculty of Human Sciences, Shimane University, Matsue, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}]",Obesity facts,['10.1159/000506813'] 367,32152869,Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS.,"INTRODUCTION This pre-specified subgroup analysis evaluated the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) triple therapy versus corresponding dual therapies in the China subgroup of the phase III, double-blind KRONOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). METHODS Patients were randomized 2:2:1:1 to BGF MDI 320/18/9.6 μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 μg twice daily for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) over weeks 12-24. Secondary endpoints included symptoms, health-related quality of life, and safety. Rate of moderate/severe COPD exacerbations was an additional efficacy endpoint. RESULTS In the China subgroup (n = 432; 22.7% of the KRONOS population), BGF MDI demonstrated nominally significant improvements in the primary endpoint versus BFF MDI (least squares mean (LSM) difference 68 mL; P = 0.0035) and BUD/FORM DPI (LSM difference 78 mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316). BGF MDI demonstrated at least numerical improvements versus comparators in secondary lung function and symptom endpoints. BGF MDI reduced the rate of moderate/severe COPD exacerbations versus GFF MDI (rate ratio 0.41; P = 0.0030), with numerical benefits versus BFF MDI and BUD/FORM DPI. All treatments were well tolerated. CONCLUSIONS Results demonstrated that BGF MDI showed benefits on lung function (vs inhaled corticosteroid/long-acting β 2 -agonist), as well as symptoms and exacerbations relative to dual therapies. Findings support BGF MDI use in Chinese patients with moderate to very severe COPD. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov NCT02497001.",2020,mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316).,"['Chinese patients with moderate to very severe COPD', 'Chinese Patients with COPD', 'Patients were randomized 2:2:1:1 to BGF MDI 320/18/9.6', 'patients with moderate to very severe chronic obstructive pulmonary disease (COPD']","['glycopyrrolate/formoterol fumarate (GFF', 'Budesonide/Glycopyrrolate/Formoterol Fumarate', 'budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) triple therapy', 'BGF MDI', 'budesonide/formoterol fumarate (BFF) MDI']","['rate of moderate/severe COPD exacerbations versus GFF MDI', 'change from baseline in morning pre-dose trough forced expiratory volume', 'Efficacy and Safety', 'symptoms, health-related quality of life, and safety', 'tolerated', 'efficacy and safety', 'lung function', 'Rate of moderate/severe COPD exacerbations', 'BFF MDI (least squares mean (LSM) difference', 'BUD/FORM DPI']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'formoterol fumarate'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1276807', 'cui_str': 'Budesonide / formoterol'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.534037,mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316).,"[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing, 100029, China. cyh-birm@263.net.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Huijie', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China.'}, {'ForeName': 'Pryseley N', 'Initials': 'PN', 'LastName': 'Assam', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Su', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bourne', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'Formerly of AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01266-5'] 368,32284181,Effect of probiotics on gut microbiome in patients with administration of surgical antibiotic prophylaxis: A randomized controlled study.,"Surgical antibiotic prophylaxis (SAP) is recommended for the prevention of surgical site infections. However, there is a concern about adverse effects of SAP, such as antibiotic-associated diarrhea (AAD). To prevent AAD, administration of probiotics has been investigated. Although recent advances in next-generation sequencing makes it possible to analyze the gut microbiome, the effect of probiotics on the gut microbiome in the patients with SAP remains unknown. To test a hypothesis that SAP influences the gut microbiome and probiotics prevent the influence, a randomized controlled study was conducted with patients who underwent spinal surgery at Nagasaki University Hospital. After obtaining informed consent, the patients were automatically classified into the non-probiotics group and the probiotics group. In the probiotics group, the patients took 1 g of Enterococcus faecium 129 BIO 3B-R, 3 times a day on postoperative days (PODs) 1-5. The feces of all patients were sampled before administration of SAP and on PODs 5 and 10. We compared alpha and beta diversity and differential abundance analysis of the gut microbiome before and after SAP. During the study period, a total of 33 patients were evaluated, comprising 17 patients in the non-probiotics group and 16 in the probiotics group. There was no significant difference between the groups regarding patient characteristics. In alpha and beta diversity, there were no significant differences among all combinations. In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.",2020,"In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.","['33 patients were evaluated, comprising 17 patients in the non-probiotics group and 16 in the probiotics group', 'patients with administration of surgical antibiotic prophylaxis', 'patients who underwent spinal surgery at Nagasaki University Hospital']","['probiotics', 'Surgical antibiotic prophylaxis (SAP']","['operational taxonomic unit level, Streptococcus gallolyticus and Roseburia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1017328', 'cui_str': 'Streptococcus gallolyticus'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}]",33.0,0.0277709,"In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.","[{'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Kaku', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. Electronic address: kaku-ngs@umin.ac.jp.'}, {'ForeName': 'Nariyoshi', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sasaki', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Tsuda', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kosai', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uno', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yoshitomo', 'Initials': 'Y', 'LastName': 'Morinaga', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tagami', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Osaki', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Yanagihara', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2020.03.008'] 369,32202337,First responder's care package on management of road traffic accident victims of Udupi: Study protocol.,"AIM To evaluate the effectiveness of 'first responder's care package' on knowledge and skill on the management of road traffic accident (RTA) victims. The outcomes relate to the quality of first responder's care by autorickshaw drivers. METHODS Autorickshaw drivers (N = 1,040) will be assessed to identify the impediments and knowledge to provide the first responder's care to RTA victims following which, 150 autorickshaw drivers will be selected based on a cut-off knowledge score to train half of them using workshops. Drivers below 55 years and willing to participate will be recruited and drivers with serious health issues, homophobia and who cannot read English or Kannada will be excluded. Randomized controlled trial with repeated measures design will be adopted. Funding for the research is by the Indian Council of Medical Research and it is registered in the Clinical Trial Registry of India. DISCUSSION Road traffic accidents are responsible for 85% of the total global mortality and 90% of the 'Disability Adjusted Life Years' in the developing countries amounting to an annual loss of $65 billion to $100 billion. India's rate of RTA deaths is high and postcrash care is not addressed efficiently by any agencies in India. Autorickshaw drivers could be ideal candidates for teaching the first responder's care package in India as they are a constant presence on the roads and reach all the main roads and small lanes of the country. IMPACT The research will add to knowledge on quality of first responder's care provided to accident victims. If the intervention is found to be fruitful for the accident victims of the locality, it can be recommended to be implemented all over the state.",2020,"AIM To evaluate the effectiveness of 'First Responder's Care Package' on knowledge and skill on the management of road traffic accident victims.","['road traffic accident victims of Udupi', ""Autorickshaw drivers (N\xa0=\xa01,040) will be assessed to identify the impediments and knowledge to provide the first responder's care to Road Traffic Accident victims following which, 150 autorickshaw drivers will be selected based on a cut-off knowledge score to train half of them using workshops"", 'Drivers below 55\xa0years and willing to participate will be recruited and drivers with serious health issues, hemophobia and who cannot read English or Kannada will be excluded', 'road traffic accident victims']","[""First Responder's Care Package""]","[""quality of First Responder's care by autorickshaw drivers""]","[{'cui': 'C0221706', 'cui_str': 'Traffic accident on public road (event)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3178988', 'cui_str': 'First Responders'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0522183', 'cui_str': 'Fear of blood (finding)'}, {'cui': 'C1277154', 'cui_str': 'Reads English'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C3178988', 'cui_str': 'First Responders'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3178988', 'cui_str': 'First Responders'}]",1040.0,0.0429836,"AIM To evaluate the effectiveness of 'First Responder's Care Package' on knowledge and skill on the management of road traffic accident victims.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vinish', 'Affiliation': 'Department of Community Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Jyothi', 'Initials': 'J', 'LastName': 'Chakrabarty', 'Affiliation': 'Department of Medical-Surgical Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Vijayan', 'Affiliation': 'Departmentt of Orthopedics, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Departmentt of Orthopedics, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Y N', 'Initials': 'YN', 'LastName': 'Shashidhara', 'Affiliation': 'Department of Community Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Baby S', 'Initials': 'BS', 'LastName': 'Nayak', 'Affiliation': 'Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Anice', 'Initials': 'A', 'LastName': 'George', 'Affiliation': 'Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, India.'}]",Journal of advanced nursing,['10.1111/jan.14368'] 370,31858732,Weight Gain Over 6 Years in Young Adults: The Study of Novel Approaches to Weight Gain Prevention Randomized Trial.,"OBJECTIVE The study objective was to determine whether two self-regulation interventions that reduced 3-year weight gain in young adults remain effective at 6 years. METHODS A randomized trial was conducted in two academic settings in 599 young adults, aged 18 to 35 years, with normal weight or overweight; 504 (84%) reconsented for a 6-year extension (Study of Novel Approaches to Weight Gain Prevention-Extended [SNAP-E]) with ongoing intervention and assessments. Weight gain over 6 years was compared for all assigned to Control, Large Changes (LC; lose 5-10 pounds initially), and Small Changes (SC; make small daily changes in intake and activity). RESULTS Weight change from baseline to 6 years did not differ significantly among the three groups (Control = 3.9 kg, SC = 4.1 kg, and LC = 2.8 kg). However, there was a significant age-by-treatment interaction (P = 0.002). Among those < 25 years old, weight gain from baseline to 6 years averaged 7.3 kg in the Control group and was reduced by almost 50% in LC and SC. LC also significantly reduced mean weight gain (area under the curve) over 6 years compared with Control or SC. CONCLUSIONS Although the interventions did not reduce weight gain at 6 years for the full cohort, they were effective in those < 25 years old. Future efforts should focus on young adults aged 18 to 24.9 and test more intensive interventions with more diverse participants.",2020,LC also significantly reduced mean weight gain (area under the curve) over 6 years compared with Control or SC,"['Young Adults', '599 young adults, aged 18 to 35\xa0years, with normal weight or overweight; 504 (84%) reconsented for a 6-year extension (Study of Novel Approaches to Weight Gain Prevention-Extended\xa0[SNAP-E]) with ongoing intervention and assessments', 'young adults remain effective at 6 years', 'young adults aged 18 to 24.9 and test more intensive interventions with more diverse participants']","['LC', 'two self-regulation interventions', 'Control or SC']","['mean weight gain', 'Weight change', '3-year weight gain', 'Weight gain', 'Weight Gain', 'weight gain']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0074709', 'cui_str': 'Snap (resin)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",599.0,0.0545748,LC also significantly reduced mean weight gain (area under the curve) over 6 years compared with Control or SC,"[{'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Letitia H', 'Initials': 'LH', 'LastName': 'Perdue', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bahnson', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Polzien', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erica F', 'Initials': 'EF', 'LastName': 'Robichaud', 'Affiliation': 'Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gorin', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Alpert Medical School of Brown University, Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22661'] 371,32280089,Concentration-Dependent Activity of Hydromethylthionine on Clinical Decline and Brain Atrophy in a Randomized Controlled Trial in Behavioral Variant Frontotemporal Dementia.,"BACKGROUND Hydromethylthionine is a potent inhibitor of pathological aggregation of tau and TDP-43 proteins. OBJECTIVE To compare hydromethylthionine treatment effects at two doses and to determine how drug exposure is related to treatment response in bvFTD. METHODS We undertook a 52-week Phase III study in 220 bvFTD patients randomized to compare hydromethylthionine at 200 mg/day and 8 mg/day (intended as a control). The principal outcomes were change on the Addenbrookes Cognitive Examination - Revised (ACE-R), the Functional Activities Questionnaire (FAQ), and whole brain volume. Secondary outcomes included Modified Clinical Global Impression of Change (Modified-CGIC). A population pharmacokinetic exposure-response analysis was undertaken in 175 of the patients with available blood samples and outcome data using a discriminatory plasma assay for the parent drug. RESULTS There were no significant differences between the two doses as randomized. There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes. There were significant exposure-dependent differences at 8 mg/day for FAQ, Modified-CGIC, and whole brain atrophy comparing patients with plasma levels greater than 0.346 ng/ml with having minimal drug exposure. The exposure-response is biphasic with worse outcomes at the high concentrations produced by 200 mg/day. CONCLUSIONS Hydromethylthionine has a similar concentration-response profile for effects on clinical decline and brain atrophy at the 8 mg/day dose in bvFTD as recently reported in AD. Treatment responses in bvFTD are predicted to be maximal at doses in the range 20-60 mg/day. A confirmatory placebo-controlled trial is now planned.",2020,There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes.,"['220 bvFTD patients', '176 of the patients with available blood samples and outcome data using a discriminatory plasma assay for the parent drug', 'Behavioral Variant Frontotemporal Dementia']","['hydromethylthionine', 'Hydromethylthionine', 'placebo']","['Modified Clinical Global Impression of Change (Modified-CGIC', 'steep concentration-response relationships for plasma levels', 'Addenbrookes Cognitive Examination - Revised (ACE-R), the Functional Activities Questionnaire (FAQ), and whole brain volume']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",220.0,0.107878,There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Shiells', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Bjoern O', 'Initials': 'BO', 'LastName': 'Schelter', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Baddeley', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ganesan', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hammel', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Vuksanovic', 'Affiliation': 'Aberdeen Biomedical Imaging Centre, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Staff', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Aberdeen Biomedical Imaging Centre, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bracoud', 'Affiliation': 'Bioclinica, Lyon, France.'}, {'ForeName': 'Damon J', 'Initials': 'DJ', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Riedel', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gauthier', 'Affiliation': ""McGill Centre for Studies in Aging, Alzheimer's Disease Research Unit, and Douglas Mental Health University Institute, Montreal, QC, Canada.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Beijing Institute for Brain Disorders Alzheimer's Disease Centre, Beijing, China.""}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Moebius', 'Affiliation': 'Moebius-Consult, Baar, Switzerland.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Hardlund', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Kipps', 'Affiliation': 'University Hospital Southampton and University of Southampton, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kook', 'Affiliation': 'Salamandra LLC, Bethesda, MD, USA.'}, {'ForeName': 'John M D', 'Initials': 'JMD', 'LastName': 'Storey', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Harrington', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191173'] 372,32280093,Impact of 3-Day Combined Anodal Transcranial Direct Current Stimulation-Visuospatial Training on Object-Location Memory in Healthy Older Adults and Patients with Mild Cognitive Impairment.,"BACKGROUND Associative object-location memory (OLM) is known to decline even in normal aging, and this process is accelerated in patients with mild cognitive impairment (MCI). Given the lack of curative treatment for Alzheimer's disease, activating cognitive resources during its preclinical phase might prevent progression to dementia. OBJECTIVE To evaluate the effects of anodal transcranial direct current stimulation (atDCS) combined with an associative episodic memory training on OLM in MCI patients and in healthy elderly (HE). METHODS In a single-blind cross-over design, 16 MCI patients and 32 HE underwent a 3-day visuospatial OLM training paired with either 20 min or 30 s (sham) atDCS (1 mA, right temporoparietal cortex). Effects on immediate (training success) and long-term memory (1-month) were investigated by conducting Mixed Model analyses. In addition, the impact of combined intervention on within-session (online) and on between-session (offline) performance were explored. RESULTS OLM training+atDCS enhanced training success only in MCI patients, but not HE (difference n.s.). Relative performance gain was similar in MCI patients compared to HE under atDCS. No beneficial effect was found after 1-month. Exploratory analyses suggested a positive impact on online, but a negative effect on offline performance in MCI patients. In both groups, exploratory post-hoc analyses indicated an association between initially low-performers and greater benefit from atDCS. CONCLUSION Cognitive training in MCI may be enhanced by atDCS, but further delineation of the impact of current brain state, as well as temporal characteristics of multi-session atDCS-training application, may be needed to induce longer-lasting effects.",2020,"RESULTS OLM training+atDCS enhanced training success only in MCI patients, but not HE (difference n.s.).","['patients with mild cognitive impairment (MCI', 'Healthy Older Adults and Patients with Mild Cognitive Impairment', '16 MCI patients and 32 HE underwent a', 'MCI patients', 'MCI patients and in healthy elderly (HE']","['3-day visuospatial OLM training paired with either 20\u200amin or 30\u200as (sham) atDCS', 'Cognitive training', 'anodal transcranial direct current stimulation (atDCS) combined with an associative episodic memory training', '3-Day Combined Anodal Transcranial Direct Current Stimulation-Visuospatial Training', 'Associative object-location memory (OLM', 'OLM training+atDCS']","['Relative performance gain', 'training success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0327004', 'cui_str': 'Olm'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0586905,"RESULTS OLM training+atDCS enhanced training success only in MCI patients, but not HE (difference n.s.).","[{'ForeName': 'Angelica Vieira Cavalcanti', 'Initials': 'AVC', 'LastName': 'de Sousa', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Neurocure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Grittner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Center for Stroke Research, Berlin, Germany.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Rujescu', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic, Martin-Luther-University Halle-Wittenberg, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Külzow', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Neurocure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Neurocure Cluster of Excellence, Berlin, Germany.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191234'] 373,30644326,Dopamine manipulations drive changes in information sampling in healthy volunteers.,"BACKGROUND Information sampling is the cognitive process of accumulating information before committing to a decision. Patients across numerous disorders show decreased information sampling relative to controls. AIMS Here, we used the Beads and the Best Choice Tasks to study the role of dopamine signaling in information sampling. METHODS Participants were given placebo, amisulpride, or ropinirole in each session, in a double-blind cross-over design. RESULTS We found that ropinirole (agonist) increased the number of beads drawn in the Beads Task specifically when participants faced a loss, and decreased the rank of the chosen option in the Best Choice Task. CONCLUSIONS These effects are likely driven by a combination of effects at presynaptic D 2 receptors, which affect dopamine release, and post-synaptic D 2 receptors. Increased D 2 relative to D 1 receptor activation in the striatum leads to increased sampling in the loss condition in the Beads Task. It also leads to choice of a poorer ranked option in the Best Choice Task. Decreased D 2 relative to D 1 receptor activation leads to decreased sampling in the Beads Task in the loss condition.",2019,"We found that ropinirole (agonist) increased the number of beads drawn in the Beads Task specifically when participants faced a loss, and decreased the rank of the chosen option in the Best Choice Task. ","['healthy volunteers', 'Participants were given']","['ropinirole (agonist', 'Dopamine', 'placebo, amisulpride, or ropinirole']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}]",[],,0.0488611,"We found that ropinirole (agonist) increased the number of beads drawn in the Beads Task specifically when participants faced a loss, and decreased the rank of the chosen option in the Best Choice Task. ","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Vicario-Feliciano', 'Affiliation': '1 Laboratory of Neuropsychology, National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Rebekah L', 'Initials': 'RL', 'LastName': 'Wigton', 'Affiliation': '2 Institute of Psychiatry, Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'White', 'Affiliation': '2 Institute of Psychiatry, Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Sukhi S', 'Initials': 'SS', 'LastName': 'Shergill', 'Affiliation': '2 Institute of Psychiatry, Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Bruno B', 'Initials': 'BB', 'LastName': 'Averbeck', 'Affiliation': '1 Laboratory of Neuropsychology, National Institutes of Health (NIH), Bethesda, MD, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118822080'] 374,32289474,"5-Year Update of a Multi-Institution, Prospective Phase 2 Hypofractionated Postmastectomy Radiation Therapy Trial.","PURPOSE Hypofractionation in the setting of postmastectomy radiation (PMRT) is not currently the standard of care in most countries. Here we present a 5-year update of our multi-institutional, phase 2 prospective trial evaluating a novel 15-day hypofractionated PMRT regimen. METHODS AND MATERIALS Patients were enrolled to receive 3.33 Gy daily to the chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4-fraction mastectomy scar boost. The primary endpoint was freedom from grade 3 or higher late non-reconstruction-related radiation toxicities. Toxicities were scored using Common Terminology Criteria for Adverse Events v4.0. Secondary endpoints included local and locoregional recurrence rates, cosmesis, and reconstruction complications. RESULTS After enrolling 69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis. At a median follow up of 54 months, there were no acute or late grade 3 and 4 nonreconstruction reported toxicities. The grade 2 or greater late toxicity rate was only 12% and comprised grade 2 pain, fatigue, and lymphedema that persisted beyond 6 months after completion of radiation therapy. Only 3 women (4.6%) experienced a chest wall or nodal recurrence as a first site of relapse. Freedom from local failure, including local failure after distant relapse, was 92% at 5 years, and the 5-year overall survival was 90%. CONCLUSIONS This is the first prospective trial conducted in the United States to demonstrate the safe and effective use of hypofractionated PMRT. We have demonstrated a low complication rate while achieving excellent local control. Toxicity was better than anticipated based on previously published series of PMRT toxicities. Although our fractionation was novel, the radiobiological equivalent dose is similar to other hypofractionation schedules. This trial was the basis for the creation of Alliance A221505 (RT CHARM), which is currently accruing patients in a phase 3 randomized design.",2020,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%. ","['Patients were enrolled to receive 3.33 Gray (Gy) daily to the', '69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis']","['post mastectomy radiation (PMRT', 'chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4 fraction mastectomy scar boost', 'Alliance Axxxxx (xxxxx', 'hypofractionated PMRT']","['late toxicity rate', 'low complication rate', 'toxicities', 'local failure after distant relapse', 'chest wall or nodal recurrence', 'Toxicities', 'Toxicity', 'freedom from grade 3 or higher late non-reconstruction related radiation toxicities', 'pain, fatigue and lymphedema', 'local and locoregional recurrence rates, cosmesis and reconstruction complications', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517690', 'cui_str': '3.33'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",69.0,0.105768,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%. ","[{'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Poppe', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah. Electronic address: matthew.poppe@hci.utah.edu.'}, {'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'Yehia', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sharad', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Kirstein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Haffty', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Atif J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.020'] 375,32291291,Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services.,"OBJECTIVES Common mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms. METHODS Randomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee's manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health. RESULTS A statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences. CONCLUSION PSI was effective in reducing sickness absence which was the primary outcome in this study.",2020,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences. ","['100 employees with stress symptoms or CMDs', 'Randomisation was conducted at the OHS consultant level and each consultant was allocated into either', 'employees with common mental disorders or stress-related symptoms at work', 'employees with CMDs or stress-related symptoms', 'Common mental disorders (CMDs']","['CAU', 'giving a brief problem-solving intervention (PSI) or care as usual (CAU']","['earlier partial RTW and the mental health', 'sickness absence', 'self-registered sickness absence, return to work (RTW) and mental health', 'registered sickness absence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028801', 'cui_str': 'Occupational health service'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",100.0,0.155075,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences. ","[{'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Keus van de Poll', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden marijke.keus.van.de.poll@ki.se.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Nybergh', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lornudd', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hagberg', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Bodin', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kwak', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Lohela-Karlsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Torgén', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Bergstrom', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106353'] 376,32051147,Novel Detection and Restorative Levodopa Treatment for Preclinical Diabetic Retinopathy.,"Diabetic retinopathy (DR) is diagnosed clinically by directly viewing retinal vascular changes during ophthalmoscopy or through fundus photographs. However, electroretinography (ERG) studies in humans and rodents have revealed that retinal dysfunction is demonstrable prior to the development of visible vascular defects. Specifically, delays in dark-adapted ERG oscillatory potential (OP) implicit times in response to dim-flash stimuli (<-1.8 log cd · s/m 2 ) occur prior to clinically recognized DR. Animal studies suggest that retinal dopamine deficiency underlies these early functional deficits. In this study, we randomized individuals with diabetes, without clinically detectable retinopathy, to treatment with either low- or high-dose Sinemet (levodopa plus carbidopa) for 2 weeks and compared their ERG findings with those of control subjects (no diabetes). We assessed dim-flash-stimulated OP delays using a novel handheld ERG system (RETeval) at baseline and 2 and 4 weeks. RETeval recordings identified significant OP implicit time delays in individuals with diabetes without retinopathy compared with age-matched control subjects ( P < 0.001). After 2 weeks of Sinemet treatment, OP implicit times were restored to control values, and these improvements persisted even after a 2-week washout. We conclude that detection of dim-flash OP delays could provide early detection of DR and that Sinemet treatment may reverse retinal dysfunction.",2020,RETeval recordings identified significant OP implicit-time delays in persons with diabetes without retinopathy compared to age-matched control s (p<0.001).,"['persons with diabetes without retinopathy', 'persons with diabetes, without clinically detectable retinopathy, to treatment with either low or high dose Sinemet (levodopa plus carbidopa) for 2 weeks and compared their ERG findings with those of control (no DM) subjects', 'Pre-Clinical Diabetic Retinopathy']",['Novel Detection and Restorative Levodopa Treatment'],"['Diabetic retinopathy (DR', 'OP implicit-time delays', 'delays in dark-adapted ERG oscillatory potential (OP) implicit times', 'OP implicit times']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0074559', 'cui_str': 'Sinemet'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}]",,0.0177311,RETeval recordings identified significant OP implicit-time delays in persons with diabetes without retinopathy compared to age-matched control s (p<0.001).,"[{'ForeName': 'Cara T', 'Initials': 'CT', 'LastName': 'Motz', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Kyle C', 'Initials': 'KC', 'LastName': 'Chesler', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Rachael S', 'Initials': 'RS', 'LastName': 'Allen', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Bales', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Lukas M', 'Initials': 'LM', 'LastName': 'Mees', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Feola', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'April Y', 'Initials': 'AY', 'LastName': 'Maa', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Darin E', 'Initials': 'DE', 'LastName': 'Olson', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, GA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Thule', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, GA.'}, {'ForeName': 'P Michael', 'Initials': 'PM', 'LastName': 'Iuvone', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, GA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Hendrick', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, GA.'}, {'ForeName': 'Machelle T', 'Initials': 'MT', 'LastName': 'Pardue', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA machelle.pardue@bme.gatech.edu.'}]",Diabetes,['10.2337/db19-0869'] 377,32185729,"New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study.","INTRODUCTION To evaluate the effects of a new lubricating, antioxidant solution (VisuEvo ® ) on dry eye disease (DED) in patients undergoing cataract surgery. METHODS Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT > 7, Schirmer I test > 15 mm/5 min) were enrolled in this multicenter, open-label, randomized, prospective study. Scheduled visits were 2 weeks before surgery (screening), day of surgery (V0), week 1 (V1), and 2 (V2) after surgery. VisuEvo ® was self-administered three times daily for the whole study duration (group A); the control group (group B) had no tear substitute administration. The primary endpoint was the change in TBUT over time; the secondary endpoints were changes in Ocular Surface Disease Index (OSDI), ocular surface staining, the Schirmer I test, and osmometry. RESULTS A total of 45 patients were included (group A, 23; group B, 22; age 74 ± 8 years). At the screening, TBUT was similar between the groups (group A, 8.5 ± 1.8 s; group B, 7.8 ± 0.7, p = 0.11). At the scheduled visits, TBUT increase vs screening visit was significantly higher in group A: +1.2 s at V0, +1.4 s at V1, and +1.9 s at V2 (p < 0.01). Also, OSDI was significantly lower in group A at V0, V1, and V2 (p < 0.027). After surgery, corneal staining was absent in 65-78% of group A compared with 54-59% in group B. The two groups did not show any significant differences of osmometry and the Schirmer I test. CONCLUSIONS The ocular surface was more protected and quickly restored from surgery when VisuEvo ® was used from 2 weeks preoperatively to 2 weeks postoperatively. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03833908.",2020,The two groups did not show any significant differences of osmometry and the Schirmer,"['patients undergoing cataract surgery', '45 patients were included (group A, 23; group B, 22; age 74\u2009±\u20098\xa0years', 'Cataract Surgery', 'Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT >\u20097, Schirmer']","['new lubricating, antioxidant solution (VisuEvo ® ']","['corneal staining', 'OSDI', 'dry eye disease (DED', 'Ocular Surface Disease Index (OSDI), ocular surface staining, the Schirmer I test, and osmometry', 'change in TBUT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C3179117', 'cui_str': 'Osmometry'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",45.0,0.0361402,The two groups did not show any significant differences of osmometry and the Schirmer,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fogagnolo', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy. paolo.fogagnolo@unimi.it.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Favuzza', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Marchina', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Cennamo', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Vignapiano', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Quisisana', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic, ASST Santi Paolo Carlo, San Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Mencucci', 'Affiliation': 'Department of Oto-Neuro-Ophthalmological Surgical Sciences Eye Clinic, University of Florence, Florence, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01288-z'] 378,30728457,Randomized phase-II trial evaluating induction therapy with idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine.,"The aim of this randomized phase-II study was to evaluate the effect of substituting cytarabine by azacitidine in intensive induction therapy of patients with acute myeloid leukemia (AML). Patients were randomized to four induction schedules for two cycles: STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide. Consolidation therapy consisted of allogeneic hematopoietic-cell transplantation or three courses of high-dose cytarabine followed by 2-year maintenance therapy with azacitidine in the azacitidine-arms. AML with CBFB-MYH11, RUNX1-RUNX1T1, mutated NPM1, and FLT3-ITD were excluded and accrued to genotype-specific trials. The primary end point was response to induction therapy. The statistical design was based on an optimal two-stage design applied for each arm separately. During the first stage, 104 patients (median age 62.6, range 18-82 years) were randomized; the study arms PRIOR and CONCURRENT were terminated early due to inefficacy. After randomization of 268 patients, all azacitidine-containing arms showed inferior response rates compared to STANDARD. Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively). The data from this trial do not support the substitution of cytarabine by azacitidine in intensive induction therapy.",2019,"Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively).","['104 patients (median age 62.6, range 18-82 years', 'patients with acute myeloid leukemia (AML']","['cytarabine', 'allogeneic hematopoietic-cell transplantation', 'idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine', 'STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide', 'cytarabine by azacitidine']","['Event-free and overall survival', 'inferior response rates', 'response to induction therapy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",268.0,0.0373509,"Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively).","[{'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany. richard.schlenk@nct-heidelberg.de.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Herr', 'Affiliation': 'Department of Hematology, Medical Oncology and Pneumology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Salih', 'Affiliation': 'Department of Hematology and Oncology, Eberhard-Karls University, Tübingen, Germany.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Derigs', 'Affiliation': 'Department of Internal Medicine III, Hospital Frankfurt-Hoechst, Frankfurt, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kuendgen', 'Affiliation': 'Department of Hematology, Oncology and Clinical Immunology, University of Duesseldorf, Medical Faculty, Duesseldorf, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ringhoffer', 'Affiliation': 'Department of Hematology and Oncology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Minden, Minden, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grießhammer', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Minden, Minden, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Department of Hematology and Oncology, Darmstadt, Municipal Hospital, Darmstadt, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department Hematology and Oncology, Braunschweig Municipal Hospital, Braunschweig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Girschikofsky', 'Affiliation': 'Department of Hematology and Oncology, Hospital Elisabethinen Linz, Linz, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Internal Medicine III, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lange', 'Affiliation': 'Department of Hematology and Oncology, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Westermann', 'Affiliation': 'Department of Hematology, Oncology and Tumor Immunology, Charité - Campus Virchow Clinic, Berlin, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'Department of Internal Medicine III, Hanuschkrankenhaus Wien, Wien, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kremers', 'Affiliation': 'Department of Internal Medicine, Caritas-Krankenhaus Lebach, Lebach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Department of Hematology and Oncology, Hospital Essen-Werden, Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Göhring', 'Affiliation': 'Institute of Human Genetics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haase', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Teleanu', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gaidzik', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Paschka', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}]",Leukemia,['10.1038/s41375-019-0395-y'] 379,31344751,Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial.,"OBJECTIVE This pilot study aimed to refine and test an adaption of family-based treatment (FBT) for eating disorders that addressed the distinct clinical needs of adolescents with overweight or obesity in the absence of eating disorder pathology. Our hypothesis was that FBT for paediatric obesity (FBT-PO) would be feasible to implement and superior to a nutrition education counselling (NEC) condition delivered to both parents and patients, thereby controlling for key information dissemination across groups while manipulating active therapeutic content and strategy. METHOD Seventy-seven adolescents were randomized to FBT-PO or NEC across two sites. RESULTS Results supported our core prediction, in that weight status among adolescent study participants receiving FBT-PO remained stable while increasing among participants randomized to NEC. Attrition was high in both conditions. CONCLUSIONS FBT-PO, while not seeming to yield a marked decrease in body mass index z-score, may arrest an otherwise-occurring weight-gain trajectory for these adolescents. This efficacy finding is consistent with the overall PO literature supporting parental involvement in the treatment of PO. Future research efforts should address retention in FBT-PO.",2019,"Attrition was high in both conditions. ","['paediatric obesity', 'Seventy-seven adolescents', 'adolescents with overweight or obesity in the absence of eating disorder pathology']","['adaption of family-based treatment (FBT', 'FBT-PO or NEC', 'FBT']","['Attrition', 'body mass index z-score']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",77.0,0.0867209,"Attrition was high in both conditions. ","[{'ForeName': 'Katharine L', 'Initials': 'KL', 'LastName': 'Loeb', 'Affiliation': 'Fairleigh Dickinson University, Teaneck, NJ.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Celio Doyle', 'Affiliation': 'Eating Disorders Center at the Evidence Based Treatment Centers of Seattle, Seattle, WA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Research, Fargo, ND.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Glunz', 'Affiliation': 'NorthShore University HealthSystem, Evanston, IL.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Laraque-Arena', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, NY.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Bacow', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Vangeepuram', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Gault', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2699'] 380,31675622,Markers of bone and lipid metabolism with eslicarbazepine acetate monotherapy.,"OBJECTIVE To evaluate the impact of eslicarbazepine acetate (ESL) monotherapy on markers of bone and lipid metabolism. METHODS We conducted a post-hoc analysis of data pooled from two Phase III, dose-blind, conversion-to-ESL (1600 mg and 1200 mg) monotherapy studies in patients with focal seizures. Laboratory measurements included lipids (total cholesterol [TC]; high-density lipoprotein cholesterol [HDL-C]; low-density lipoprotein cholesterol; and triglycerides) and markers of bone metabolism (alkaline phosphatase; 25-hydroxyvitamin D; osteocalcin; and parathyroid hormone [PTH]); measurements were taken at baseline, Week 18, and Month 12, and analyzed according to enzyme-inducing antiepileptic drugs (EIAEDs) use at baseline (+EIAED and -EIAED subgroups). RESULTS Data from 337 treatment-compliant patients were used for the Week 18 analyses (+EIAED subgroup, n = 119; -EIAED subgroup, n = 218); data from 161 treatment-compliant patients were used for the Month 12 analyses (+EIAED subgroup, n = 53; -EIAED subgroup, n = 108). At baseline, alkaline phosphatase and PTH concentrations were higher in the + EIAED versus -EIAED subgroup. Changes from baseline in markers of bone turnover were generally insignificant, except for some elevation in alkaline phosphatase in the -EIAED subgroup (18 weeks and 12 months) and osteocalcin in both subgroups (18 weeks only). Regarding lipids, TC and HDL-C concentrations were higher in the + EIAED versus -EIAED subgroup at baseline. Concentrations of markers of lipid metabolism fell in the + EIAED group and rose in the -EIAED group, reaching very similar values that were intermediate between the -EIAED and + EIAED baseline values. CONCLUSIONS Based on this retrospective analysis, ESL seems to have had only a modest and primarily clinically insignificant impact on plasma lipids. More prospective data are needed to definitively ascertain the effects of ESL on bone metabolism.",2019,"Regarding lipids, TC and HDL-C concentrations were higher in the + EIAED versus -EIAED subgroup at baseline.",['patients with focal seizures'],"['ESL', 'conversion-to-ESL', 'eslicarbazepine acetate (ESL) monotherapy', 'eslicarbazepine acetate monotherapy']","['bone turnover', 'Concentrations of markers of lipid metabolism fell', 'lipids (total cholesterol [TC]; high-density lipoprotein cholesterol [HDL-C]; low-density lipoprotein cholesterol; and triglycerides) and markers of bone metabolism (alkaline phosphatase; 25-hydroxyvitamin D; osteocalcin; and parathyroid hormone [PTH]); measurements', 'plasma lipids', 'alkaline phosphatase and PTH concentrations', 'alkaline phosphatase', 'Regarding lipids, TC and HDL-C concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C2725262', 'cui_str': 'eslicarbazepine acetate'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]",337.0,0.259068,"Regarding lipids, TC and HDL-C concentrations were higher in the + EIAED versus -EIAED subgroup at baseline.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Mintzer', 'Affiliation': 'Department of Neurology, Jefferson Comprehensive Epilepsy Center, Thomas Jefferson University, Philadelphia, PA, USA. Electronic address: Scott.Mintzer@jefferson.edu.'}, {'ForeName': 'Tawnya', 'Initials': 'T', 'LastName': 'Constantino', 'Affiliation': 'Department of Neurology, Intermountain Neuroscience Institute at IMC, Murray, UT, USA. Electronic address: Tawnya.Constantino@imail.org.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Gidal', 'Affiliation': 'School of Pharmacy and Department of Neurology, University of Wisconsin-Madison, Madison, WI, USA. Electronic address: barry.gidal@wisc.edu.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: Parul.Bhargava@sunovion.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA. Electronic address: David.Blum@sunovion.com.'}]",Epilepsy research,['10.1016/j.eplepsyres.2019.106216'] 381,32145277,Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Exploratory Single-Blinded Randomized Controlled Trial.,"OBJECTIVE To compare the effects of unilateral and bilateral arm training on arm impairment in severely affected patients with stroke. DESIGN Single-blinded, randomized controlled trial. SETTING Inpatient rehabilitation center. PARTICIPANTS First-time subacute patients (N=69) with stroke and a nonfunctional hand. Patients were stratified according to lesion location post hoc. INTERVENTIONS Repetitive bilateral arm training on an arm cycle followed by synchronized bilateral repetitive distal hand training or an identical unilateral arm training performed by the paretic limb only. Both unilateral and bilateral trainings were administered twice daily over 6 weeks. MAIN OUTCOME MEASURES The primary outcome measure was the Fugl-Meyer Assessment (FMA) score for the arm, and secondary measures were biomechanical parameters measuring isometric force and rate of force generation. Outcome measures were assessed before, at the end of, and 2 weeks after intervention. RESULTS Patients were homogeneous at study onset. All patients improved regarding the FMA arm score and most biomechanical parameters after intervention. Yet the post hoc analysis stratifying patients according to lesion location showed that patients with pure subcortical stroke, but not patients with cortical involvement of stroke, showed a significantly greater improvement (P=.022) following the bilateral training in FMA arm score (from 6.8±5.7 to 17.8±15.8) compared with unilateral training (from 6.5±7.8 to 8.7±8.6). CONCLUSIONS The benefit of bilateral arm training followed by repetitive bilateral hand training for motor control of the severely paretic upper limb may depend on lesion location. Further studies with larger sample size are required for the validation of these results.",2020,All patients improved regarding the FMA and most biomechanical parameters after intervention.,"['severely affected stroke patients', 'Severely Affected Stroke Patients', 'Inpatient rehabilitation center', 'Sixty-nine first time subacute patients with stroke and a non-functional hand', 'Patients were homogeneous at study onset']","['Bilateral Arm Training versus unilateral Arm Training', 'Repetitive bilateral arm training on an ""arm-cycle"" followed by synchronized bilateral repetitive distal hand training, or an identical unilateral arm training performed by the paretic limb only', 'unilateral and bilateral arm training', 'repetitive bilateral hand training']","['Fugl-Meyer Score for the arm (FMA), and secondary measures were biomechanical parameters measuring isometric force and rate of force generation']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0205300', 'cui_str': 'Non-functional (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]",,0.160241,All patients improved regarding the FMA and most biomechanical parameters after intervention.,"[{'ForeName': 'Caroline I E', 'Initials': 'CIE', 'LastName': 'Renner', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany. Electronic address: c.c.renner@t-online.de.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Brendel', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Hummelsheim', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.007'] 382,32283048,An Innovative STRoke Interactive Virtual thErapy (STRIVE) Online Platform for Community-Dwelling Stroke Survivors: A Randomized Controlled Trial.,"OBJECTIVE To investigate the STRoke Interactive Virtual thErapy (STRIVE) intervention on upper-extremity clinical outcomes in community-dwelling stroke survivors. DESIGN Assessor-blinded randomized controlled trial. SETTING Study screening and testing was conducted in a university clinic. Participants completed the virtual therapy (VT) intervention in a community-based stroke support group setting. PARTICIPANTS Of 124 stroke survivors initially assessed, 60 participants were recruited (time poststroke, 13.4±8.9 y). Participants were allocated to either VT or control group using a block randomization design and were stratified by sex. INTERVENTIONS Participants were randomized to receive 8 weeks of VT or usual care. The intervention consisted of approximately 45 minutes of twice weekly VT training on the Jintronix Rehabilitation System. MAIN OUTCOME MEASURES Between-group differences in the Fugl-Meyer Upper Extremity scale and Action Research Arm Test score were joint primary outcomes in this study. RESULTS Significant between-group differences for the Fugl-Meyer Upper Extremity scale were seen at the end of the intervention (F 1, 1 =5.37, P=.02, d=0.41). No significant differences were observed with the Action Research Arm Test. No adverse events were reported. CONCLUSIONS We demonstrated clinically meaningful improvements in gross upper extremity motor function and use of the affected arm after a VT intervention delivered via a community-based stroke support group setting. This data adds to the contexts in which VT can be used to improve upper limb function. Use of VT in community-based rehabilitation in chronic stroke recovery is supported.",2020,"RESULTS Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","['community-dwelling stroke survivors', 'Study screening and testing was conducted in a University clinic', 'Of 124 stroke survivors initially assessed, 60 participants were recruited (time post-stroke 13.4 ± 8.9 years']","['virtual therapy (VT) intervention in a community-based stroke support group setting', 'VT training', 'VT intervention delivered via a community-based stroke support group setting', 'VT', 'STRoke Interactive Virtual thErapy (STRIVE) intervention', 'VT or usual care', 'innovative STRoke Interactive Virtual thErapy (STRIVE) online platform']","['1) Fugl-Meyer Upper Extremity scale, and 2) Action Research Arm Test score', 'Fugl-Meyer Upper Extremity scale', 'adverse events']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0902791,"RESULTS Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia; Faculty of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; National Health and Medical Research Council Stroke Rehabilitation and Brain Recovery Centre of Research Excellence, The Florey Institute of Neuroscience and Mental Health, Melbourne, Australia.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Bird', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Launceston, Australia; Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Makii', 'Initials': 'M', 'LastName': 'Muthalib', 'Affiliation': 'Silverline Research, Brisbane, Australia; EuroMov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia; Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore. Electronic address: weipeng.teo@nie.edu.sg.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.011'] 383,30887865,Dose-dependent effects of the selective serotonin reuptake inhibitor citalopram: A combined SPECT and phMRI study.,"BACKGROUND Serotonin transporter blockers, like citalopram, dose-dependently bind to the serotonin transporter. Pharmacological magnetic resonance imaging (phMRI) can be used to non-invasively monitor effects of serotonergic medication. Although previous studies showed that phMRI can measure the effect of a single dose of serotoninergic medication, it is currently unclear whether it can also detect dose-dependent effects. AIMS To investigate the dose-dependent phMRI response to citalopram and compared this with serotonin transporter occupancy, measured with single photon emission computed tomography (SPECT). METHODS Forty-five healthy females were randomized to pre-treatment with placebo, a low (4 mg) or clinically standard (16 mg) oral citalopram dose. Prior to citalopram, and 3 h after, subjects underwent SPECT scanning. Subsequently, a phMRI scan with a citalopram challenge (7.5 mg intravenously) was conducted. Change in cerebral blood flow in response to the citalopram challenge was assessed in the thalamus and occipital cortex (control region). RESULTS Citalopram dose-dependently affected serotonin transporter occupancy, as measured with SPECT. In addition, citalopram dose-dependently affected the phMRI response to intravenous citalopram in the thalamus (but not occipital cortex), but phMRI was less sensitive in distinguishing between groups than SPECT. Serotonin transporter occupancy showed a trend-significant correlation to thalamic cerebral blood flow change. CONCLUSION These results suggest that phMRI likely suffers from higher variation than SPECT, but that these techniques probably also assess different functional aspects of the serotonergic synapse; therefore phMRI could complement positron emission tomography/SPECT for measuring effects of serotonergic medication.",2019,"Serotonin transporter occupancy showed a trend-significant correlation to thalamic cerebral blood flow change. ",['Forty-five healthy females'],"['citalopram', 'selective serotonin reuptake inhibitor citalopram', 'single photon emission computed tomography (SPECT', 'placebo, a low (4 mg) or clinically standard (16 mg) oral citalopram', 'citalopram challenge', 'Pharmacological magnetic resonance imaging (phMRI']","['thalamic cerebral blood flow change', 'phMRI response', 'serotonin transporter occupancy', 'cerebral blood flow']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0170657', 'cui_str': 'Serotonin Plasma Membrane Transport Proteins'}]",45.0,0.0391363,"Serotonin transporter occupancy showed a trend-significant correlation to thalamic cerebral blood flow change. ","[{'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Schrantee', 'Affiliation': '1 Amsterdam University Medical Centers, Academic Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Solleveld', 'Affiliation': '1 Amsterdam University Medical Centers, Academic Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Schwantje', 'Affiliation': '1 Amsterdam University Medical Centers, Academic Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Willem B', 'Initials': 'WB', 'LastName': 'Bruin', 'Affiliation': '3 Amsterdam University Medical Centers, Academic Medical Center, Department of Psychiatry, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk-Jan Mm', 'Initials': 'HM', 'LastName': 'Mutsaerts', 'Affiliation': '1 Amsterdam University Medical Centers, Academic Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Sofie M', 'Initials': 'SM', 'LastName': 'Adriaanse', 'Affiliation': '1 Amsterdam University Medical Centers, Academic Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lucassen', 'Affiliation': '2 Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Booij', 'Affiliation': '1 Amsterdam University Medical Centers, Academic Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Reneman', 'Affiliation': '1 Amsterdam University Medical Centers, Academic Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119836229'] 384,32278752,Novel Trilaminar Polymeric Antiadhesion Membrane Prevents Postoperative Pericardial Adhesion.,"BACKGROUND Postoperative pericardial adhesion formation is a prominent cause of morbidity and death in cardiovascular surgery, but there is still no ideal prevention method, especially in redo cases. This study investigated a novel antiadhesion trilaminar polymeric film compared with the Gore PRECLUDE Pericardial Membrane (W. L. Gore & Associates, Flagstaff, AZ) and a negative control. METHODS Our novel trilaminar membrane is composed of polyvinyl alcohol (PVA) and carboxymethylcellulose (CMC). An established pericardial adhesion rabbit model was used to test the property of the membrane. After sternotomy, a portion of pericardium was resected and the epicardium was abraded. Rabbits (n = 24) were randomly assigned to 3 groups: control group, no trilaminar membrane or expanded polytetrafluoroethylene (ePTFE); ePTFE group, or trilaminar membrane group (PVA-CMC group). Evaluation of adhesion formation was performed by resternotomy 4 weeks after the operation. RESULTS The degree of tissue adhesion surrounding the heart in the PVA-CMC group was significantly less than in the control (P < .01) and ePTFE (P < .05) groups. The inflammation score in group PVA-CMC was significantly lower than that in the ePTFE (P < .01) and control (P < .01) groups. The fibrosis score was significantly lower in group PVA-CMC than that in the ePTFE (P < .05) and control (P < .01) groups. CONCLUSIONS The novel trilaminar membrane effectively reduced postoperative pericardial adhesions. The placement of the trilaminar membrane at the time of sternal closure provides a novel combination to minimize the extent and severity of pericardial adhesions while providing a physical barrier between the sternum and the cardiac structures.",2020,The inflammation score in group PVA-CMC was significantly lower than that in groups of ePTFE (P＜0.01) and control (P＜0.01).,['Rabbits (n=24'],"['control group, no trilaminar membrane or expanded polytetrafluoroethylene; expanded polytetrafluoroethylene (ePTFE) group, and trilaminar membrane group (PVA-CMC group', 'polyvinyl alcohol (PVA) and carboxymethylcellulose (CMC']","['fibrosis score', 'degree of tissue adhesion', 'postoperative pericardial adhesion', 'adhesion formation', 'inflammation score', 'postoperative pericardial adhesions']","[{'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032623', 'cui_str': 'Polyvinyl Alcohol'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}]","[{'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2609313', 'cui_str': 'Pericardial adhesions'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",24.0,0.0152563,The inflammation score in group PVA-CMC was significantly lower than that in groups of ePTFE (P＜0.01) and control (P＜0.01).,"[{'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Vascular Surgery, The First Hospital of Tsinghua University, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Department of Vascular Surgery, The First Hospital of Tsinghua University, Beijing, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiac Surgery, The First Hospital of Tsinghua University, Beijing, China.'}, {'ForeName': 'Baohua', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Department of Chemical Engineering, Tsinghua University, Beijing, China.'}, {'ForeName': 'Whitney Annie', 'Initials': 'WA', 'LastName': 'Long', 'Affiliation': 'School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Yingmao', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Pathology, The First Hospital of Tsinghua University, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Vascular Surgery, The First Hospital of Tsinghua University, Beijing, China. Electronic address: lilei@lilei.net.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.011'] 385,32281816,Effects of a family diabetes self-management education intervention on the patients' supporters.,"INTRODUCTION Diabetes self-management education (DSME) programs that engage the families of patients with diabetes have shown to be effective in improving diabetes-related outcomes of the patients. The health effects of these ""family models"" of DSME on participating family members are rarely studied. Opportunity exists for the participating family members to benefit from the healthy lifestyle recommendations offered through such programs. METHOD Using data from a randomized controlled trial to assess the effect of family DSME compared to standard DSME among Marshallese adults with Type 2 diabetes, this study examined baseline to 12-month changes in A1c, body mass index (BMI), food consumption, and physical activity among participating family members, comparing outcomes of family members based on attended at least 1 (n = 98) versus attended no (n = 44) DSME sessions. RESULTS Overall, family member attendance was low. There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups. After controlling for attendance and sociodemographic measures, lowering of BMI was the only significant predictor of not having an A1c level indicative of diabetes at 12 months. DISCUSSION Future research on family DSME should consider ways to improve family member attendance; have them set their own health improvement goals; and integrate healthy lifestyle education, such as healthy eating and being physically active, along with the DSME core content to create an added benefit of diabetes prevention for participating family members. The limitations of this study and recommendations for future research are provided. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups.","[""patients' supporters"", 'Marshallese adults with Type 2 diabetes', 'among participating family members, comparing outcomes of family members based on attended at least 1 (n = 98) versus attended no (n = 44) DSME sessions']","['standard DSME', 'family diabetes self-management education intervention', 'family DSME']","['A1c, BMI, food consumption, and physical activity', 'A1c, body mass index (BMI), food consumption, and physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574386', 'cui_str': 'Marshallese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0207488,"There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups.","[{'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Felix', 'Affiliation': 'Fay W. Boozman College of Public Health.'}, {'ForeName': 'M Rachelle', 'Initials': 'MR', 'LastName': 'Narcisse', 'Affiliation': 'Office of Community Health and Research.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Long', 'Affiliation': 'College of Medicine.'}, {'ForeName': 'Pearl A', 'Initials': 'PA', 'LastName': 'McElfish', 'Affiliation': 'College of Medicine.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000470'] 386,31815370,Vitamin D status in preterm neonates and the effects of its supplementation on respiratory distress syndrome.,"AIM The aim of this study was to investigate the status and effects of vitamin D supplement as adjuvant therapy in the management of respiratory distress syndrome (RDS) in preterm infants. PATIENT AND METHODS Vitamin D was prospectively studied in 196 preterm neonates, 96 of them developed RDS, which further subdivided into three subgroups (subgroup received just conventional therapy, subgroup received conventional therapy plus vitamin D 400 IU/day, and subgroup received conventional therapy plus vitamin D 800 IU/day). The patient selection for each treatment subgroup was done by computed randomization, and all the patients had the same treatment protocols assigned for each subgroup. RESULTS The preterm group who developed RDS had lower vitamin D concentrations than the preterm group without RDS (*P < .001). Also, the subgroups supplemented with vitamin D had lower Downes Respiratory Distress score and PaCO 2 levels, less duration of hospitalization, and complications rates than the subgroup without vitamin D supplementation. The subgroup supplemented with 800 IU/day vitamin D showed also significantly improvement, less hospitalization duration, and less complications than those supplemented with 400 IU/day. CONCLUSIONS 25-hydroxyvitamin D concentration was deficient in most preterm babies especially those who developed RDS. Administration of 800 IU/day vitamin D as an adjuvant therapy in cases of RDS was associated with significant decreased in severity, rate of complications, and duration of hospital stay in preterm neonates with RDS.",2020,"Also, the subgroups supplemented with vitamin D had lower Downes Respiratory Distress score and PaCO 2 levels, less duration of hospitalization, and complications rates than the subgroup without vitamin D supplementation.","['preterm neonates with RDS', '196 preterm neonates, 96 of them developed RDS, which further subdivided into three subgroups (subgroup received', 'preterm infants', 'preterm neonates']","['vitamin D', 'just conventional therapy, subgroup received conventional therapy plus vitamin D 400\u2009IU/day, and subgroup received conventional therapy plus vitamin D', '800\u2009IU/day vitamin D', 'vitamin D supplement']","['25-hydroxyvitamin D concentration', 'hospitalization duration, and less complications', 'respiratory distress syndrome', 'vitamin D concentrations', 'severity, rate of complications, and duration of hospital stay', 'lower Downes Respiratory Distress score and PaCO 2 levels, less duration of hospitalization, and complications rates', 'respiratory distress syndrome (RDS']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.222907,"Also, the subgroups supplemented with vitamin D had lower Downes Respiratory Distress score and PaCO 2 levels, less duration of hospitalization, and complications rates than the subgroup without vitamin D supplementation.","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Beltagi', 'Affiliation': 'Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Rowiesha', 'Affiliation': 'Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Abdelrahman', 'Initials': 'A', 'LastName': 'Elmashad', 'Affiliation': 'Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Shymaa M', 'Initials': 'SM', 'LastName': 'Elrifaey', 'Affiliation': 'Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Hemat', 'Initials': 'H', 'LastName': 'Elhorany', 'Affiliation': 'Biochemistry Depatment, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Hassan Gamal', 'Initials': 'HG', 'LastName': 'Koura', 'Affiliation': 'Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Pediatric pulmonology,['10.1002/ppul.24552'] 387,30816793,Catecholaminergic effects on inhibitory control depend on the interplay of prior task experience and working memory demands.,"BACKGROUND Catecholamines affect response inhibition, but the effects of methylphenidate on inhibitory control in healthy subjects are heterogenous. Theoretical considerations suggest that working memory demands and learning/familiarization processes are important factors to consider regarding catecholaminergic effects on response inhibition. AIMS The purpose of this study was to examine the role of working memory demands and familiarization for methylphenidate effects on response inhibition. METHODS Twenty-eight healthy adults received a single dose of methylphenidate (0.5 mg/kg) or placebo in a randomised, double-blind, crossover study design. The subjects were tested using a working memory-modulated response inhibition paradigm that combined a Go/Nogo task with a mental rotation task. RESULTS Methylphenidate effects were largest in the most challenging mental rotation condition. The direction of effects depended on the extent of the participants' task experience. When performing the task for the first time, methylphenidate impaired response inhibition performance in the most challenging mental rotation condition, as reflected by an increased false alarm rate. In sharp contrast to this, methylphenidate seemed to improve response execution performance in the most challenging condition when performing the task for the second time as reflected by reaction times on Go trials. CONCLUSION Effects of catecholamines on inhibitory control processes depend on the interplay of two factors: (a) working memory demands, and (b) learning or familiarization with a task. It seems that the net effect of increases in gain control and decreases in working memory processes determines the methylphenidate effect on response inhibition. Hence, crossover study designs likely underestimate methylphenidate effects on cognitive functions.",2019,"When performing the task for the first time, methylphenidate impaired response inhibition performance in the most challenging mental rotation condition, as reflected by an increased false alarm rate.","['Twenty-eight healthy adults', 'healthy subjects']","['methylphenidate', 'placebo', 'working memory-modulated response inhibition paradigm that combined a Go/Nogo task with a mental rotation task', 'catecholamines']","['response execution performance', 'cognitive functions', 'false alarm rate', 'response inhibition performance']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",28.0,0.139233,"When performing the task for the first time, methylphenidate impaired response inhibition performance in the most challenging mental rotation condition, as reflected by an increased false alarm rate.","[{'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Bensmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Zink', 'Affiliation': 'Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Roessner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119827815'] 388,31606226,A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum.,"BACKGROUND AND PURPOSE Xerostomia is frequently reported after radiotherapy (RT) for head and neck cancer (HNC). The aim of this study was to reduce symptoms of radiation-induced xerostomia in HNC survivors, in which the experimental arm used chewing gum for a month. Primary endpoint was changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms. MATERIALS AND METHODS Participants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum were, for a month, randomized (2:1) to: (Arm A) daily chewing gum or (Arm B) standard care. Xerostomia-related QOL was assessed using EORTC QLQ-H&N35 and GRIX questionnaires along with measurement of salivary flow and viscosity at inclusion and after one month. The study was registered on ClinicalTrials.gov (NCT03302676). RESULTS Ninety-one participants were eligible for analysis (Arm A, n = 55; Arm B, n = 36). Comparing categorized scores for symptoms between arms, reduction of dry mouth was significantly higher for Arm A than Arm B (p = 0.05). A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms. Salivary flow increased and viscosity decreased upon five minutes of stimulation within both arms (p < 0.001, respectively), however no significantly difference was observed between arms. CONCLUSION Categorized scores found reduction of dry mouth to be significantly higher in Arm A than Arm B, but no difference was seen for salivary flow rate and viscosity.",2020,A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms.,"['Participants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum', 'head and neck cancer (HNC', 'Ninety-one participants were eligible for analysis (Arm A, n\u202f=\u202f55; Arm B, n\u202f=\u202f36']","['alleviating radiation-induced xerostomia with chewing gum', 'radiotherapy (RT', 'daily chewing gum or (Arm B) standard care']","['reduction of dry mouth', 'Salivary flow increased and viscosity', 'Xerostomia-related QOL', 'salivary flow rate and viscosity', 'dry mouth scores', 'changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0566340', 'cui_str': 'Able to chew (finding)'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1275047', 'cui_str': 'Radiation-induced xerostomia'}, {'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4301986', 'cui_str': 'Viscosity (property) (qualifier value)'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",91.0,0.0565416,A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms.,"[{'ForeName': 'Julie Killerup', 'Initials': 'JK', 'LastName': 'Kaae', 'Affiliation': 'Department of Oncology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; OPEN, Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense C, Denmark. Electronic address: Julie.Killerup.Kaae@rsyd.dk.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Stenfeldt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Hyrup', 'Affiliation': 'Fertin Pharma A/S, Vejle, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Brink', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; Laboratory of Radiation Physics, Odense University Hospital, Denmark.'}, {'ForeName': 'Jesper Grau', 'Initials': 'JG', 'LastName': 'Eriksen', 'Affiliation': 'Experimental Clinical Oncology, Department of Oncology, Aarhus University Hospital, Denmark.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.09.013'] 389,32279367,"An extension of the RITUX-ERAH study, multicenter randomized clinical trial comparing rituximab to placebo in acute antibody-mediated rejection after renal transplantation.","The treatment of active antibody-mediated rejection (ABMR) is still a matter of debate, the place of rituximab remaining controversial. The French multicenter double-blind RITUX-ERAH study included 38 patients with ABMR in the first year of renal transplantation. All patients received plasma exchanges, intravenous immunoglobulins, and corticosteroids and were randomly assigned rituximab or placebo infusion at day 5. Additional rituximab infusions were allowed. In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups. Long-term data are needed to conclude. Evaluation of the 7-year outcomes of the RITUX-ERAH study patients according to the rituximab or placebo treatment received. Eleven patients received placebo and 27 at least one infusion of rituximab. Seven years after ABMR, death-censored kidney allograft survival and renal function were not different between the groups. The evolution of anti-HLA sensitization was similar. There was no statistically significant difference in the incidence of infectious or neoplastic complications, but to be noted, seven cancers developed in six patients treated with rituximab (mean period of 44 months post-ABMR). In this cohort, there was no benefit 7 years after ABMR of rituximab in addition to plasma exchanges, intravenous immunoglobulins, and steroids.",2020,"In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups.","['38 patients with ABMR in the first year of renal transplantation', 'acute antibody-mediated rejection after renal transplantation']","['plasma exchanges, intravenous immunoglobulins, corticosteroids and were randomly assigned rituximab or placebo', 'rituximab or placebo', 'placebo', 'rituximab']","['death-censored kidney allograft survival and renal function', 'graft survival and renal function', 'incidence of infectious or neoplastic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",38.0,0.401729,"In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Bailly', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ville', 'Affiliation': 'Institut de Transplantation Urologie Néphrologie (ITUN), CHU Nantes and Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blancho', 'Affiliation': 'Institut de Transplantation Urologie Néphrologie (ITUN), CHU Nantes and Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morelon', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Lyon Edouard Herriot, Lyon, France.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Bamoulid', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Besançon, Besançon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Caillard', 'Affiliation': 'Nephrology-Transplantation Department, University Hospital, Strasbourg, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Chatelet', 'Affiliation': 'Centre Universitaire des Maladies Rénales, CHU de Caen, Caen, France.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Malvezzi', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Tourret', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Assistance Publique - Hôpitaux de Paris, Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vuiblet', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Reims, Reims, France.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Anglicheau', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Assistance Publique - Hôpitaux de Paris, Necker Hospital, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bertrand', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Rouen, Rouen, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grimbert', 'Affiliation': 'Service de Néphrologie et Transplantation, Pôle Cancérologie-Immunité-Transplantation-Infectiologie et Unité INSERM 955, CHU Henri Mondor et Université Paris-Est, Creteil, France.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Haidar', 'Affiliation': 'Department of Hemodialysis, CHT Noumea, Noumea, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hazzan', 'Affiliation': 'Service de Néphrologie, CHU Lille and Inserm U995, Lille, France.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Merville', 'Affiliation': 'Department of Nephrology, Transplantation, Dialysis and Apheresis, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Mousson', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Dijon, Dijon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pernin', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pouteil-Noble', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, E. Herriot Hospital, Université Lyon I, Lyon, France.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Purgus', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Marseille, Marseille, France.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Sayegh', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Westeel', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Amiens, Amiens, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Sautenet', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gatault', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Büchler', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13613'] 390,31512160,"The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity, and Quality of Life.","PURPOSE The aim of this study was to investigate the effect of chest physiotherapy (CP) applied to patients undergoing bariatric surgery on pulmonary functions, dyspnea levels, functional capacity, and quality of life. METHODS The patients were randomized and divided into two groups each comprising 74 patients. CP and mobilization was applied to the patients in the first group, and only mobilization was applied to the patients in the second group. The treatment of the patients was started on the first postoperative day and continued until the postoperative 4th day. CP and mobilization were applied twice a day, 8 times in total. The following parameters were evaluated: arterial blood gas, oxygen saturation, respiratory function test for pulmonary functions, pulmonary artery pressure for pulmonary hypertension, Borg dyspnea score for severity of dyspnea, 6-min walk test(6MWT) for functional capacity, Nottingham Health Profile for quality of life. RESULTS The mean age of the patients was 38.00 ± 7.04 years. Compared with pretreatment and posttreatment dyspnea score, 6MWT, oxygen saturation, vital capacity, tidal volume, PEF, pulmonary arterial pressure, and quality of life were significantly higher in patients who underwent CP compared with the control group(p = 0.008, 0.004, 0.005, 0.027, 0.029, 0.028, 0.007, 0.012).There was a significant improvement in all the parameters of the patients who underwent chest physiotherapy when compared with the intragroup comparisons, whereas in the control group, only 6MWT and quality of life score showed a significant improvement in the border (p = 0.037, 0.046). CONCLUSION Postoperative CP applied to patients who had bariatric surgery showed that the patients improved their respiratory functions, regulated arterial blood gases, increased oxygen saturation, functional capacity and quality of life, and decreased dyspnea levels.",2020,"Compared with pretreatment and posttreatment dyspnea score, 6MWT, oxygen saturation, vital capacity, tidal volume, PEF, pulmonary arterial pressure, and quality of life were significantly higher in patients who underwent CP compared with the control group(p = 0.008, 0.004, 0.005, 0.027, 0.029, 0.028, 0.007, 0.012).There was a significant improvement in all the parameters of the patients who underwent chest physiotherapy when compared with the intragroup comparisons, whereas in the control group, only 6MWT and quality of life score showed a significant improvement in the border (p = 0.037, 0.046). ","['The mean age of the patients was 38.00 ± 7.04\xa0years', 'patients undergoing']","['bariatric surgery', 'chest physiotherapy (CP', 'Chest Physiotherapy']","['respiratory functions, regulated arterial blood gases, increased oxygen saturation, functional capacity and quality of life, and decreased dyspnea levels', 'arterial blood gas, oxygen saturation, respiratory function test for pulmonary functions, pulmonary artery pressure for pulmonary hypertension, Borg dyspnea score for severity of dyspnea, 6-min walk test(6MWT) for functional capacity, Nottingham Health Profile for quality of life', 'posttreatment dyspnea score, 6MWT, oxygen saturation, vital capacity, tidal volume, PEF, pulmonary arterial pressure, and quality of life', 'pulmonary functions, dyspnea levels, functional capacity, and quality of life', 'CP and mobilization', 'Pulmonary Functions, Functional Capacity, and Quality of Life', '6MWT and quality of life score']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest (regime/therapy)'}]","[{'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035227', 'cui_str': 'Respiratory Function Tests'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile (assessment scale)'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]",74.0,0.0136186,"Compared with pretreatment and posttreatment dyspnea score, 6MWT, oxygen saturation, vital capacity, tidal volume, PEF, pulmonary arterial pressure, and quality of life were significantly higher in patients who underwent CP compared with the control group(p = 0.008, 0.004, 0.005, 0.027, 0.029, 0.028, 0.007, 0.012).There was a significant improvement in all the parameters of the patients who underwent chest physiotherapy when compared with the intragroup comparisons, whereas in the control group, only 6MWT and quality of life score showed a significant improvement in the border (p = 0.037, 0.046). ","[{'ForeName': 'Tomris', 'Initials': 'T', 'LastName': 'Duymaz', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Bilgi University, Hacı Ahmet Mh. Pir Hüsamettin Sk. No:20, Beyoğlu, 34440, Istanbul, Turkey. tomrisduymaz@gmail.com.'}, {'ForeName': 'Onder', 'Initials': 'O', 'LastName': 'Karabay', 'Affiliation': 'Department of General Surgery, Yedikule Surp Pırgiç Ermeni Hospital, Zakirbaşı Sokak No:32, Kazlıçeşme, 34020, Istanbul, Turkey.'}, {'ForeName': 'Ibrahim Halil', 'Initials': 'IH', 'LastName': 'Ural', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Beykent University, Cumhuriyet Mah. Beykent Üniversitesi Büyükçekmece, Külliyesi, Büyükçekmece, 34500, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-019-04165-z'] 391,32255785,Effects of photobiomodulation on interleukin-10 and nitrites in individuals with relapsing-remitting multiple sclerosis - Randomized clinical trial.,"OBJECTIVE Investigate the effects of photobiomodulation (PBM) on the expression of IL-10 and nitrites in individuals with Relapsing-Remitting multiple sclerosis (MS), as these biomarkers play a fundamental role in the physiopathology of the disease. The modulation of IL-10 and nitrites through treatment with PBM may be a novel treatment modality for MS. METHODS A randomized, uncontrolled, clinical trial was conducted involving 14 individuals with a diagnosis of Relapsing-Remitting MS and a score of up to 6.0 on the Expanded Disability Status Scale (EDSS). THE PARTICIPANTS WERE RANDOMIZED TO TWO GROUPS Group 1 -PBM in the sublingual region; Group 2 -PBM over the radial artery. Irradiation was administered with a wavelength of 808 nm and output power of 100 mW for 360 seconds twice a week, totaling 24 sessions. Peripheral blood was analyzed for the determination of serum levels of IL-10 and nitrites. RESULTS After treatment with PBM, the expression of IL-10 increased in both the sublingual group (pre-treatment: 2.8 ± 1.4 pg/ml; post-treatment: 8.3 ± 2.4 pg/ml) and the radial artery group (pre-treatment: 2.7 pg/ml ± 1.4; post-treatment: 11.7 ± 3.8 pg/ml). In contrast, nitrite levels were not modulated in the sublingual group (pre-treatment: 65 ± 50 nmol/mg protein; post-treatment: 51 ± 42 nmol/mg protein) or the radial artery group (pre-treatment: 51 ± 16 nmol/mg protein; post-treatment: 42 ± 7 nmol/mg protein). CONCLUSION Treatment with PBM positively modulated the expression of IL-10 but had no effect on nitrite levels. Further studies should be conducted with a larger sample and a control group, as PBM may be a promising complementary treatment for the management of MS. This trial is registered at ClinicalTrials.gov. Identifier: NCT03360487.",2020,"Investigate the effects of photobiomodulation (PBM) on the expression of IL-10 and nitrites in individuals with Relapsing-Remitting multiple sclerosis (MS), as these biomarkers play a fundamental role in the physiopathology of the disease.","['individuals with Relapsing-Remitting multiple sclerosis (MS', '14 individuals with a diagnosis of Relapsing-Remitting MS and a score of up to 6.0 on the Expanded Disability Status Scale (EDSS', 'individuals with relapsing-remitting multiple sclerosis']","['radial artery group (pre-treatment: 51 ± 16 nmol/mg protein; post-treatment: 42 ± 7 nmol/mg protein', 'photobiomodulation', 'photobiomodulation (PBM']","['expression of IL-10', 'Peripheral blood', 'interleukin-10 and nitrites', 'nitrite levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439291', 'cui_str': 'mmol/kg'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0580333', 'cui_str': 'Urine nitrite'}]",14.0,0.0615259,"Investigate the effects of photobiomodulation (PBM) on the expression of IL-10 and nitrites in individuals with Relapsing-Remitting multiple sclerosis (MS), as these biomarkers play a fundamental role in the physiopathology of the disease.","[{'ForeName': 'Tamiris', 'Initials': 'T', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Yara Dadalti', 'Initials': 'YD', 'LastName': 'Fragoso', 'Affiliation': 'Universidade Metropolitana de Santos, UNIMES, Santos, SP, Brasil.'}, {'ForeName': 'Maria Fernanda Setúbal', 'Initials': 'MFS', 'LastName': 'Destro Rodrigues', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Andréa Oliver', 'Initials': 'AO', 'LastName': 'Gomes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Fernanda Cordeiro', 'Initials': 'FC', 'LastName': 'da Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Andreo', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Viana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela de Fátima', 'Initials': 'DF', 'LastName': 'Teixeira da Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Chavantes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina Ratto', 'Initials': 'ACR', 'LastName': 'Tempestini Horliana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Kátia', 'Initials': 'K', 'LastName': 'De Angelis', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Alessandro Melo', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Luciana Prats', 'Initials': 'LP', 'LastName': 'Branco', 'Affiliation': 'Universidade Metropolitana de Santos, UNIMES, Santos, SP, Brasil.'}, {'ForeName': 'Kristianne Porta', 'Initials': 'KP', 'LastName': 'Santos Fernandes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0230551'] 392,32273125,Antioxidant Vitamins for Cataracts: 15-Year Follow-up of a Randomized Trial.,,2020,,['Cataracts'],['Antioxidant Vitamins'],[],"[{'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}]",[],,0.103686,,"[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Srinivasan', 'Affiliation': 'Aravind Eye Care System, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Ravilla Duraisami', 'Initials': 'RD', 'LastName': 'Ravindran', 'Affiliation': 'Aravind Eye Care System, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Division of Epidemiology, School of Public Health, University of California, Berkeley, California.'}, {'ForeName': 'Usha R', 'Initials': 'UR', 'LastName': 'Kim', 'Affiliation': 'Aravind Eye Care System, Madurai, Tamil Nadu, India.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wilkins', 'Affiliation': 'Casey Eye Institute, Oregon Health Sciences University and Lions VisionGift, Portland, Oregon.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Whitcher', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California; Department of Epidemiology & Biostatistics, University of California, San Francisco, California; Institute for Global Health, University of California, San Francisco, California.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Gritz', 'Affiliation': 'Johns Hopkins Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. Electronic address: jeremy.keenan@ucsf.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.050'] 393,31509614,"Greater mindfulness associated with lower pain, fatigue, and psychological distress in women with metastatic breast cancer.","OBJECTIVE Women with metastatic breast cancer (MBC) report high levels of disease-related symptoms including pain, fatigue, psychological distress, and sleep disturbance. Mindfulness may be particularly relevant to women with MBC given the high symptom burden and psychological toll of this disease; however, the topic is understudied among this patient population. Therefore, we aimed to test the associations between mindfulness and patient-reported symptoms among a sample of women with MBC. METHODS Sixty-four women with MBC completed baseline questionnaires of mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF]) and symptoms of pain severity and interference, fatigue, psychological distress, and sleep disturbance as part of a randomized controlled trial of a Mindful Yoga intervention. Correlational analyses of data collected at baseline tested associations between the five mindfulness facets (observing, describing, acting with awareness, nonjudging, and nonreactivity) and patient-reported measures of symptoms. RESULTS Overall, higher mindfulness was associated with lower symptom levels including lower pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance. However, degree of association varied by mindfulness facet. Nonreactivity, nonjudging, and describing showed the most frequent associations and largest effect sizes across symptoms, while observing showed the least frequent associations and lowest effect sizes. CONCLUSIONS Mindfulness-and in particular nonreactivity, nonjudging, and describing-may be a personal resource for women with MBC in coping with complex symptoms of this life-threatening illness. Findings are discussed relative to their implications for interventions aimed at increasing mindfulness in this vulnerable population.",2020,"Overall, higher mindfulness was associated with lower symptom levels including lower pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance.","['women with MBC', 'Women with metastatic breast cancer (MBC', '64 women with MBC completed', 'Women with Metastatic Breast Cancer']",['Mindful Yoga intervention'],"['baseline questionnaires of mindfulness (FFMQ-SF) and symptoms of pain severity and interference, fatigue, psychological distress, and sleep disturbance', 'pain, fatigue, psychological distress, and sleep disturbance', 'pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance', 'Lower Pain, Fatigue, and Psychological Distress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",64.0,0.0543269,"Overall, higher mindfulness was associated with lower symptom levels including lower pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Zimmaro', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health and Sciences University, Oregon, Portland.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, Duke University Medical Center, North Carolina.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}]",Psycho-oncology,['10.1002/pon.5223'] 394,31056705,"URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers.","OBJECTIVE URC102, a novel and potent inhibitor of human uric acid transporter 1 (hURAT1), is currently under clinical development to treat patients with gout. We performed a randomized, double-blind, placebo-controlled, phase I study to evaluate the safety, tolerability, pharmacodynamic, and pharmacokinetic profiles of URC102 after single and multiple oral administration in healthy male subjects. METHODS Thirty-one Koreans and 23 Caucasians received a single dose of URC102 at 1-30 mg and 1-10 mg, respectively, while 44 Koreans received URC102 once-daily for 7 days at 1-20 mg. We evaluated safety and tolerability throughout the study, and serially determined serum uric acid, the fractional excretion of uric acid and URC102 concentrations. RESULTS URC102 was well tolerated over the dose range of 1-10 mg after single and multiple administration. URC102 rapidly reduced serum uric acid, which was maintained over the entire treatment period. Furthermore, URC102 increased the area-under-the-effect curve over 168 h for fractional excretion of uric acid in a dose-dependent manner. The maximum plasma concentration and the area under the plasma concentration-time curve of URC102 increased dose-proportionally. The pharmacokinetic and pharmacodynamics characteristics of URC102 were similar in Koreans and Caucasians. CONCLUSION URC102 was safe and effectively lowered serum uric acid, which should be tested and confirmed in patients with hyperuricaemia and/or gout through further studies. TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT01953497 and NCT02524678.",2019,The maximum plasma concentration and the area under the plasma concentration-time curve of URC102 increased dose-proportionally.,"['Thirty-one Koreans and 23 Caucasians', 'patients with gout', 'healthy volunteers', 'healthy male subjects', 'patients with hyperuricaemia and/or gout through further studies']","['hURAT1', 'placebo', 'URC102']","['tolerated', 'safety and tolerability', 'serum uric acid', 'maximum plasma concentration and the area under the plasma concentration-time curve of URC102', 'safety, tolerability, pharmacodynamic, and pharmacokinetic profiles of URC102', 'serum uric acid, the fractional excretion of uric acid and URC102 concentrations']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]",,0.214196,The maximum plasma concentration and the area under the plasma concentration-time curve of URC102 increased dose-proportionally.,"[{'ForeName': 'Hyun A', 'Initials': 'HA', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Sang-In', 'Initials': 'SI', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul, Korea.'}, {'ForeName': 'Seonghae', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Clinical Trials Center, Seoul National University Bundang Hospital, Kyeonggido, Korea.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Onohara', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Youngjoo', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'JW Pharmaceutical Corporation, Seoul, Korea.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez140'] 395,32267878,Remote ischemic preconditioning does not influence lectin pathway protein levels in head and neck cancer patients undergoing surgery.,"BACKGROUND Cancer patients who undergo tumor removal, and reconstructive surgery by transfer of a free tissue flap, are at high risk of surgical site infection and ischemia-reperfusion injury. Complement activation through the lectin pathway (LP) may contribute to ischemia-reperfusion injury. Remote ischemic preconditioning (RIPC) is a recent experimental treatment targeting ischemia-reperfusion injury. The study aims were to investigate LP protein plasma levels in head and neck cancer patients compared with healthy individuals, to explore whether RIPC affects LP protein levels in head and neck cancer surgery, and finally to examine the association between postoperative LP protein levels and the risk of surgical site infection. METHODS Head and neck cancer patients (n = 60) undergoing tumor resection and reconstructive surgery were randomized 1:1 to RIPC or sham intervention administered intraoperatively. Blood samples were obtained preoperatively, 6 hours after RIPC/sham, and on the first postoperative day. LP protein plasma levels were measured utilizing time-resolved immunofluorometric assays. RESULTS H-ficolin and M-ficolin levels were significantly increased in cancer patients compared with healthy individuals (both P ≤ 0.02). Conversely, mannan-binding lectin (MBL)-associated serine protease (MASP)-1, MASP-3, collectin liver-1 (CL-L1), and MBL-associated protein of 44 kilodalton (MAp44) levels were decreased in cancer patients compared with healthy individuals (all P ≤ 0.04). A significant reduction in all LP protein levels was observed after surgery (all P < 0.001); however, RIPC did not affect LP protein levels. No difference was demonstrated in postoperative LP protein levels between patients who developed surgical site infection and patients who did not (all P > 0.13). CONCLUSIONS The LP was altered in head and neck cancer patients. LP protein levels were reduced after surgery, but intraoperative RIPC did not influence the LP. Postoperative LP protein levels were not associated with surgical site infection.",2020,"No difference was demonstrated in postoperative LP protein levels between patients who developed surgical site infection and patients who did not (all P > 0.13). ","['head and neck cancer patients undergoing surgery', 'head and neck cancer patients', 'Cancer patients who undergo tumor removal, and reconstructive surgery by transfer of a free tissue flap', 'Head and neck cancer patients (n = 60) undergoing tumor resection and reconstructive surgery', 'head and neck cancer patients compared with healthy individuals']","['Remote ischemic preconditioning (RIPC', 'RIPC or sham intervention administered intraoperatively', 'Remote ischemic preconditioning']","['LP protein levels', 'H-ficolin and M-ficolin levels', 'mannan-binding lectin (MBL)-associated serine protease (MASP)-1, MASP-3, collectin liver-1 (CL-L1), and MBL-associated protein of 44 kilodalton (MAp44) levels', 'postoperative LP protein levels', 'Postoperative LP protein levels', 'LP protein plasma levels']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0441031', 'cui_str': 'Free flap'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}]","[{'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0217532', 'cui_str': 'ficolin'}, {'cui': 'C0673667', 'cui_str': 'M-ficolin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0960371', 'cui_str': 'PRSS1 protein, human'}, {'cui': 'C0377274', 'cui_str': 'Collectin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1532717', 'cui_str': 'kDa'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",60.0,0.045339,"No difference was demonstrated in postoperative LP protein levels between patients who developed surgical site infection and patients who did not (all P > 0.13). ","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Andreas Engel', 'Initials': 'AE', 'LastName': 'Krag', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Julie Brogaard', 'Initials': 'JB', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Birgitte Jul', 'Initials': 'BJ', 'LastName': 'Kiil', 'Affiliation': 'Department of Plastic and Breast Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}]",PloS one,['10.1371/journal.pone.0230411'] 396,32065359,Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study.,"INTRODUCTION Ezetimibe/statin combination therapy has been reported to provide additional cardioprotective effects compared to statin monotherapy. The apolipoprotein B/A1 (apoB/A1) ratio is an effective predictor of cardiovascular diseases. The aim of this study was to compare the efficacy and safety of rosuvastatin/ezetimibe combination therapy versus rosuvastatin monotherapy using the apoB/A1 ratio in patients with diabetes and hypercholesterolemia. METHODS In this randomized, multicenter, open-label, parallel-group study, patients were randomly assigned to receive the combination therapy of rosuvastatin 5 mg/ezetimibe 10 mg once daily (n = 68) or monotherapy with rosuvastatin 10 mg once daily (n = 68), for 8 weeks. RESULTS After the 8-week treatment, percentage change (least-square means ± standard error) in the apoB/A1 ratio in the rosuvastatin/ezetimibe group was significantly decreased compared to the rosuvastatin group (- 46.14 ± 1.58% vs.  - 41.30 ± 1.58%, respectively; P = 0.03). In addition, the proportion of patients achieving > 50% reduction in low-density lipoprotein-cholesterol (LDL-C) and in the comprehensive lipid target (LDL-C < 70 mg/dL, non-HDL-cholesterol [non-HDL-C] < 100 mg/dL, and apoB < 80 mg/dL) was significantly different between the two groups (76.5 and 73.5% in the rosuvastatin/ezetimibe group and 47.1 and 45.6% in the rosuvastatin group, respectively; P < 0.001). The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group. Both treatments were well tolerated, and no between-group differences in drug-related adverse events were observed. CONCLUSION The apoB/A1 ratio was significantly reduced in patients receiving combination therapy with ezetimibe and rosuvastatin compared to those receiving rosuvastatin monotherapy. Both treatments were well tolerated in patients with type 2 diabetes and hypercholesterolemia. TRIAL REGISTRATION NCT03446261.",2020,"The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group.","['Patients With Type 2 Diabetes', 'patients with diabetes and hypercholesterolemia', 'patients with type 2 diabetes and hypercholesterolemia']","['monotherapy with rosuvastatin', 'rosuvastatin 5\xa0mg/ezetimibe', 'Ezetimibe/statin combination therapy', 'ezetimibe and rosuvastatin', 'rosuvastatin/ezetimibe combination therapy versus rosuvastatin monotherapy', 'Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy', 'rosuvastatin/ezetimibe', 'rosuvastatin', 'rosuvastatin monotherapy']","['drug-related adverse events', 'efficacy and safety', 'tolerated', 'apoB/A1 ratio', 'total cholesterol, non-HDL-C, LDL-C, and apoB', 'low-density lipoprotein-cholesterol (LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",,0.0149835,"The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group.","[{'ForeName': 'Jiwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.'}, {'ForeName': 'You-Cheol', 'Initials': 'YC', 'LastName': 'Hwang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Korea.'}, {'ForeName': 'Woo Je', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.'}, {'ForeName': 'Jong Chul', 'Initials': 'JC', 'LastName': 'Won', 'Affiliation': 'Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, 1342, Dongil-ro, Nowon-gu, Seoul, 01757, Korea.'}, {'ForeName': 'Kee-Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Division of Endocrinology and Metabolism, Konkuk University Medical Center, Konkuk University School of Medicine, 120, Neungdong-ro, Gwangjin-gu, Seoul, 05029, Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29, Saemunan-ro, Jongno-gu, Seoul, 03181, Korea.'}, {'ForeName': 'Kyu Jeung', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Korea. ahnkj@khu.ac.kr.'}, {'ForeName': 'Joong-Yeol', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea. jypark@amc.seoul.kr.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00778-1'] 397,32243432,"Investigating the impact of early-life adversity on physiological, immune, and gene expression responses to acute stress: A pilot feasibility study.","OBJECTIVE Exposure to early-life adversity (ELA) can result in long-term changes to physiological systems, which predispose individuals to negative health outcomes. This biological embedding of stress-responsive systems may operate via dysregulation of physiological resources in response to common stressors. The present pilot study outlines a novel experimental design to test how young adults' exposure to ELA influences neuroendocrine and inflammatory responses to acute stress. MATERIALS AND METHODS Participants were 12 males (mean age = 21.25), half of whom endorsed at least three significant adverse events up to age 18 years ('ELA group'), and half who confirmed zero ('controls'). Using a randomized within-subjects, between-groups experimental design, we induced acute psychosocial stress (Trier Social Stress Test, TSST), and included a no-stress control condition one week apart. During these sessions, we obtained repeated measurements of physiological reactivity, gene expression of the glucocorticoid receptor (NR3C1), and plasma levels of pro-inflammatory cytokines (IL-1β, IL-6, IL-8 and TNFα) over a 4-hour window post-test. RESULTS In this pilot study, the ELA group evinced higher cortisol response and blunted NR3C1 gene expression in response to the TSST compared with controls, while no differences were observed in the no-stress condition. For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups. CONCLUSION Overall, this pilot feasibility study provides a framework to investigate the biological embedding of early-adversity via dysregulation across physiological and genomic systems in response to acute psychosocial stress. ELA may program such systems in a maladaptive manner more likely to manifest during times of duress, predisposing individuals to the negative health consequences of everyday stressors. Future studies with larger sample size including both males and females are needed to replicate and expand upon these preliminary findings.",2020,"For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups. ","['young adults', 'acute stress', ""Participants were 12 males (mean age = 21.25), half of whom endorsed at least three significant adverse events up to age 18 years ('ELA group'), and half who confirmed zero ('controls""]","['TSST', 'ELA']","['physiological reactivity, gene expression of the glucocorticoid receptor (NR3C1), and plasma levels of pro-inflammatory cytokines (IL-1β, IL-6, IL-8 and TNFα', 'cortisol response and blunted NR3C1 gene expression', 'acute psychosocial stress (Trier Social Stress Test, TSST']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid receptor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",12.0,0.0355585,"For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups. ","[{'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Shalev', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Waylon J', 'Initials': 'WJ', 'LastName': 'Hastings', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Etzel', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Salomon', 'Initials': 'S', 'LastName': 'Israel', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Russell', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Kelsie A', 'Initials': 'KA', 'LastName': 'Hendrick', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Zinobile', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Sue Rutherford', 'Initials': 'SR', 'LastName': 'Siegel', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}]",PloS one,['10.1371/journal.pone.0221310'] 398,32236116,Glycemic effect of post-meal walking compared to one prandial insulin injection in type 2 diabetic patients treated with basal insulin: A randomized controlled cross-over study.,"Studies demonstrate that post-meal walking decreases postprandial hyperglycemia in type 2 diabetic patients but it has never been tested with the active treatment comparator. The objective of this study was to determine the effect of post-meal walking on glycemic control compared with one prandial insulin in type 2 diabetic patients who failed basal insulin. A randomized controlled cross-over study of post-meal walking or one prandial insulin was done in type 2 diabetic patients who were being treated with basal insulin between May 2017 and March 2018. In post-meal walking group, patients walked after meal for 15-20 minutes one meal a day every day for 6 weeks. In prandial insulin (basal plus) group, one prandial insulin was injected before breakfast or main meal with rapid-acting insulin. The primary outcome was a difference in HbA1c reduction in post-meal walking compared with basal plus groups. Fourteen patients completed the study. By intention-to-treat analysis, HbA1c was reduced by -0.05(range:-1.08 to 0.74) and -0.19(range:-0.8 to 0.56) % in post-meal walking and basal plus groups respectively. By per-protocol analysis, post-meal walking and basal plus groups decreased HbA1c by 0.13(range:-0.74 to 1.08) and 0.2(range:-0.56 to 0.8) %, respectively. There was were no significant differences in HbA1c reduction from baseline in each group and between groups in both intention-to-treat and per-protocol analysis. Fructosamine levels were decreased by 17.5(-59 to 43) and 10(-15 to 40) μmol/L, respectively at 3 and 6 weeks in post-meal walking group whereas the respective changes in basal plus group were 12.5(-17 to 64) and 17.5(-28 to 38) μmol/L and there were no significant differences in fructosamine reduction from baseline in each group and between groups. In conclusion, although post-meal walking might be as effective as one prandial insulin to improve glycemic control in type 2 diabetic patients who failed basal insulin but the magnitude of reduction was small. A longer-term study with a larger sample size or with a different walking protocol is required.",2020,There was were no significant differences in HbA1c reduction from baseline in each group and between groups in both intention-to-treat and per-protocol analysis.,"['type 2 diabetic patients treated with basal insulin', 'type 2 diabetic patients who were being treated with basal insulin between May 2017 and March 2018', 'type 2 diabetic patients who failed basal insulin', 'Fourteen patients completed the study', 'type 2 diabetic patients']","['prandial insulin (basal plus) group, one prandial insulin was injected before breakfast or main meal with rapid-acting insulin', 'prandial insulin injection', 'post-meal walking', 'post-meal walking or one prandial insulin']","['Glycemic effect', 'postprandial hyperglycemia', 'fructosamine reduction', 'Fructosamine levels', 'HbA1c reduction']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1549040', 'cui_str': 'Before breakfast'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0623641,There was were no significant differences in HbA1c reduction from baseline in each group and between groups in both intention-to-treat and per-protocol analysis.,"[{'ForeName': 'Onnicha', 'Initials': 'O', 'LastName': 'Suntornlohanakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chatvara', 'Initials': 'C', 'LastName': 'Areevut', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Saetung', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Atiporn', 'Initials': 'A', 'LastName': 'Ingsathit', 'Affiliation': 'Division of Nephrology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chatchalit', 'Initials': 'C', 'LastName': 'Rattarasarn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0230554'] 399,32236147,Physiological response and cardiorespiratory adaptation after a 6-week Nordic Walking training targeted at lipid oxidation in a group of post-menopausal women.,"This study examined the effects of a 6-week Nordic Walking (NW) training, at the intensity corresponding to the dominance of lipid metabolism, on the levels of selected physiological indices, the haemodynamic indices of the cardiovascular system and physical fitness in sedentary women older than 55 years of age. In addition, the physiological response of the female body to the walking effort on treadmill with poles (NW) and without poles (W) was compared and the influence of training on this response was determined. A single group study with a pre-test/post-test study design was conducted. Eighteen women performed NW controlled intensity training 3 times a week for 6 weeks. Body composition, resting blood pressure (BP), heart rate (HR), maximum oxygen uptake (VO2max) as well as circulatory and respiratory indices in two graded walking efforts on mechanical treadmill NW and W were measured before and after training period. The intensity of workouts, which considered the dominance of lipid metabolism, was determined individually, based on the dynamics of changes in the level of physiological indices during the graded intensity NW. After the course of training, body mass, fat mass, resting BP and HR decreased significantly (p < 0.05). HR and respiratory exchange ratio recorded during NW and W at 1.75 m.s-1 walking speed decreased, while the oxygen pulse increased (p < 0.05). VO2max increased significantly (p < 0.05). Before and after the training period HR, oxygen uptake per minute, and energy expenditure during NW were significantly higher than in W (p < 0.05). The study showed that 6-week NW training at the intensity corresponding to the dominance of lipid metabolism can provide improvement in body composition, cardiovascular function and physical performance in previously sedentary women. NW compared to the regular walk with the same speed revealed higher energy expenditure.",2020,"HR and respiratory exchange ratio recorded during NW and W at 1.75 m.s-1 walking speed decreased, while the oxygen pulse increased (p < 0.05).","['previously sedentary women', 'a group of post-menopausal women', 'sedentary women older than 55 years of age', 'Eighteen women']","['Nordic Walking training targeted at lipid oxidation', '6-week Nordic Walking (NW) training']","['HR and respiratory exchange ratio', 'Physiological response and cardiorespiratory adaptation', 'VO2max', 'body composition, cardiovascular function and physical performance', 'oxygen uptake per minute, and energy expenditure during NW', 'Body composition, resting blood pressure (BP), heart rate (HR), maximum oxygen uptake (VO2max) as well as circulatory and respiratory indices in two graded walking efforts on mechanical treadmill NW and W', 'body mass, fat mass, resting BP and HR', 'energy expenditure', 'oxygen pulse']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0451423', 'cui_str': 'Respiratory index'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0492078', 'cui_str': 'Treadmill, mechanical'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]",18.0,0.0211707,"HR and respiratory exchange ratio recorded during NW and W at 1.75 m.s-1 walking speed decreased, while the oxygen pulse increased (p < 0.05).","[{'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Cebula', 'Affiliation': 'Department of Biological Regeneration and Posture Correction, Faculty of Physical Education and Sport, University of Physical Education, Krakow, Poland.'}, {'ForeName': 'Anna Katarzyna', 'Initials': 'AK', 'LastName': 'Tyka', 'Affiliation': 'Department of Recreation and Biological Regeneration, Faculty of Tourism and Leisure, University of Physical Education, Krakow, Poland.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Tyka', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Krakow, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Pałka', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Krakow, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Biochemistry and Basic of Cosmetology, Faculty of Cosmetology, University of Physical Education, Krakow, Poland.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Luty', 'Affiliation': 'Department of Statistics and Econometrics, University of Agriculture, Krakow, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Mucha', 'Affiliation': 'Department of Biological Regeneration and Posture Correction, Faculty of Physical Education and Sport, University of Physical Education, Krakow, Poland.'}]",PloS one,['10.1371/journal.pone.0230917'] 400,31929405,Antenatal Intracellular Concentrations of Tenofovir Diphosphate and Emtricitabine Triphosphate and Associations Between Tenofovir Diphosphate and Severe Adverse Pregnancy Outcomes: IMPAACT-PROMISE (1077BF) Trial.,"BACKGROUND In the Promoting Maternal and Infant Survival Everywhere (PROMISE) trial, tenofovir disoproxil fumarate (TDF) use was associated with moderate or severe adverse pregnancy/neonatal outcomes. This study characterized tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations in dried blood spots (DBS) and assessed association between severe adverse pregnancy/neonatal outcomes and TFV-DP concentration. METHODS Retrospective case-control study of PROMISE trial arm-C women randomized to receive TDF, FTC, and ritonavir-boosted lopinavir (LPV/r), who took at least 1 dose of TDF + FTC and had week-4 postrandomization DBS drawn before delivery. Cases, defined as severe adverse pregnancy/neonatal outcomes (very preterm delivery before 34 weeks of gestation, stillbirth ≥20 weeks of gestation, or infant death before 14 days-of-age), were matched to controls (1:2 ratio) by site and gestational age at entry. Week 4 and week 8 DBS samples were assayed for TFV-DP and FTC-TP by liquid chromatography and tandem mass spectrometry. Associations were tested using Wilcoxon rank test and conditional logistic regression. RESULTS Of 447 PROMISE arm-C women, 33 met case definitions, and overall, 22 cases and 44 controls were analyzed. Median (interquartile range) concentrations of TFV-DP at weeks 4 and 8 were 706 (375-1023) fmol/punch and 806 (414-1265) fmol/punch, respectively. Odds ratio (95% confidence interval) for severe adverse pregnancy/neonatal outcome with natural log of TFV-DP concentrations as the predictor were 1.27 (0.74 to 2.18) and 1.74 (0.66 to 4.60) at weeks 4 and 8, respectively. Median (interquartile range) concentrations of FTC-TP at weeks 4 and 8 were 0.27 (0.05-0.36) pmol/punch and 0.29 (0.05-0.40) pmol/punch, respectively. CONCLUSIONS TFV-DP concentrations in DBS appeared not to be associated with severe adverse pregnancy/neonatal outcomes, although sample size was limited.",2020,"Median (interquartile range) concentrations of FTC-TP at weeks 4 and 8 were 0.27 (0.05-0.36) pmol/punch and 0.29 (0.05-0.40) pmol/punch, respectively. ",['and Severe Adverse Pregnancy Outcomes'],"['tenofovir disoproxil fumarate (TDF', 'TDF, FTC, and ritonavir-boosted lopinavir (LPV/r), who took at least 1 dose of TDF + FTC', 'Tenofovir Diphosphate and Emtricitabine Triphosphate', 'tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP', 'Tenofovir Diphosphate']","['Median (interquartile range) concentrations of FTC-TP', 'severe adverse pregnancy/neonatal outcomes (very preterm delivery before 34 weeks of gestation, stillbirth ≥20 weeks of gestation, or infant death', 'Odds ratio', 'severe adverse pregnancy/neonatal outcome with natural log of TFV-DP concentrations', 'Median (interquartile range) concentrations of TFV-DP']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0146894', 'cui_str': 'triphosphate'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0549159', 'cui_str': 'Infant Death'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]",447.0,0.220524,"Median (interquartile range) concentrations of FTC-TP at weeks 4 and 8 were 0.27 (0.05-0.36) pmol/punch and 0.29 (0.05-0.40) pmol/punch, respectively. ","[{'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Aizire', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Brooks', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Division of Neonatology, School of Medicine, Boston University, Boston, MA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Flynn', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Kiser', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'Division of Prevention, Care & Treatment, Office of HIV/AIDS, United States Agency for International Development (USAID), Arlington, VA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Mae', 'Initials': 'M', 'LastName': 'Cababasay', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002247'] 401,31235709,"A comparison of a novel endoscopic ""Su-Wang technique"" with the open ""Jaboulay's procedure"" for the surgical treatment of adult primary vaginal hydrocele.","This paper was aimed to introduce and compare outcomes of a novel ""Su-Wang (S-W) technique"" for endoscopic treatment of adult hydrocele with conventional open hydrocelectomy with ""Jaboulay's (JA) procedure"" regarding adverse events (AEs) and patient satisfaction. In the randomized controlled trial, adult males with primary hydroceles were prospectively assigned into S-W or JA group. We recorded perioperative data and postoperative AEs (incision length, recurrence, hematoma, wound infection and edema vanished time). Finally, a total of 42 adult patients underwent the S-W (n = 22) or JA (n = 20) procedure. Procedures were successfully completed for all 42 patients. No significant differences were found between the two groups regarding age, symptom duration, body mass index, and size of the hydrocele. The incision length was significantly shorter in the S-W group (1.00 ± 0.24 cm) than in the JA group (6.10 ± 1.46 cm). After 6 months' follow-up, complete data of 90.5% (38/42) were obtained. Severe AEs did not occur in any patient. Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction in the S-W group were superior to those in the JA group. All patients in the S-W group were satisfied with this novel procedure, particularly due to the minimally invasive incision. In conclusion, the novel ""S-W technique"" for hydrocelectomy provided satisfactory cosmetic results with a 1-cm scrotal incision only. With the near-complete excision of the parietal TV, it resulted in no recurrence, fewer AEs, and rapid postoperative rehabilitation in comparison to the traditional ""JA procedure."" The endoscopic ""S-W technique"" may be a viable alternative for the surgical treatment of adult primary vaginal hydrocele.",2019,"Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction in the S-W group were superior to those in the JA group.","['adult hydrocele with conventional open hydrocelectomy with ""Jaboulay\'s (JA', '42 adult patients underwent the S-W (n\u2009=\u200922) or', 'adult males with primary hydroceles', 'adult primary vaginal hydrocele']","['JA', 'novel endoscopic ""Su-Wang technique"" with the open ""Jaboulay\'s procedure', 'novel ""Su-Wang (S-W) technique']","['Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction', 'age, symptom duration, body mass index, and size of the hydrocele', 'perioperative data and postoperative AEs (incision length, recurrence, hematoma, wound infection and edema vanished time', 'incision length']","[{'cui': 'C3875182', 'cui_str': 'Adult hydrocele (disorder)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194977', 'cui_str': 'Hydrocelectomy (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1720771', 'cui_str': 'Scrotal Hydrocele'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1720771', 'cui_str': 'Scrotal Hydrocele'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",42.0,0.0412537,"Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction in the S-W group were superior to those in the JA group.","[{'ForeName': 'Junhao', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China. 13697326659@139.com.'}, {'ForeName': 'Xinghuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China. wangxinghuan@whu.edu.cn.'}]",Scientific reports,['10.1038/s41598-019-45229-5'] 402,31249332,Effects of Kinect-based exergaming on frailty status and physical performance in prefrail and frail elderly: A randomized controlled trial.,"Frailty status can be improved by intervention. Both exergaming and combined exercise have been proposed for improving physical performance in community-dwelling elderly. However, whether frailty status can be improved by exergaming is unclear. Moreover, whether Kinect-based exergaming training can exert a stronger effect on improving frailty status than combined exercise needs to be established. The aim of this study was to investigate the effects of Kinect-based exergaming on improving frailty status and physical performance in the prefrail and frail elderly by comparing its effects with those of combined exercise. Fifty-two prefrail and frail elderly were recruited and randomized to the Kinect-based exergaming group (EXER group) or combined exercise group (CE group), emphasizing resistance, aerobic, and balance training for 36 sessions over 12 weeks. Our results showed that both groups improved the frailty status (EXER group: p = 0.016, effect size = 2.29; and CE group: p = 0.031, effect size = 2.67). Three out of 5 physical characteristics of the frailty phenotype, namely, weakness, slow walking speed, and low activity level, were significantly reversed by both exergaming and combined exercise. However, the exergaming training also significantly reversed exhaustion. Furthermore, compared with the CE group, the EXER group showed greater improvement in dynamic balance control, as indicated by the forward reaching test (p = 0.0013, effect size = 0.40) and single leg stance test (p = 0.049, effect size = 0.42). Thus, Kinect-based exergaming exerted effects that were at least as beneficial as those of combined exercise in improving frailty status and the frailty phenotype. We recommend the use of exergaming aided by Kinect in the prefrail and frail elderly.",2019,"Our results showed that both groups improved the frailty status (EXER group: p = 0.016, effect size = 2.29; and CE group: p = 0.031, effect size = 2.67).","['community-dwelling elderly', 'Fifty-two prefrail and frail elderly', 'prefrail and frail elderly']","['Kinect-based exergaming training', 'combined exercise', 'Kinect-based exergaming group (EXER group) or combined exercise group (CE group), emphasizing resistance, aerobic, and balance training', 'CE', 'Kinect-based exergaming', 'exergaming and combined exercise', 'EXER']","['frailty status and physical performance', 'frailty phenotype, namely, weakness, slow walking speed, and low activity level', 'frailty status', 'single leg stance test', 'dynamic balance control', 'physical performance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0079377', 'cui_str': 'Frail Elders'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2607857'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",5.0,0.0353323,"Our results showed that both groups improved the frailty status (EXER group: p = 0.016, effect size = 2.29; and CE group: p = 0.031, effect size = 2.67).","[{'ForeName': 'Ying-Yi', 'Initials': 'YY', 'LastName': 'Liao', 'Affiliation': 'Department of Gerontological Health Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'I-Hsuan', 'Initials': 'IH', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Therapy, Fooyin University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ray-Yau', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan. rywang@ym.edu.tw.'}]",Scientific reports,['10.1038/s41598-019-45767-y'] 403,31249363,Pulmonary rehabilitation improves survival in patients with idiopathic pulmonary fibrosis undergoing lung transplantation.,"This study was conducted to evaluate whether a pulmonary rehabilitation program (PRP) is independently associated with survival in patients with idiopathic pulmonary fibrosis (IPF) undergoing lung transplant (LTx). This quasi-experimental study included 89 patients who underwent LTx due to IPF. Thirty-two completed all 36 sessions in a PRP while on the waiting list for LTx (PRP group), and 53 completed fewer than 36 sessions (controls). Survival after LTx was the main outcome; invasive mechanical ventilation (IMV), length of stay (LOS) in intensive care unit (ICU) and in hospital were secondary outcomes. Kaplan-Meier curves and Cox regression models were used in survival analyses. Cox regression models showed that the PRP group had a reduced 54.0% (hazard ratio = 0.464, 95% confidence interval 0.222-0.970, p = 0.041) risk of death. A lower number of patients in the PRP group required IMV for more than 24 hours after LTx (9.0% vs. 41.6% p = 0.001). This group also spent a mean of 5 days less in the ICU (p = 0.004) and 5 days less in hospital (p = 0.046). In conclusion, PRP PRP completion halved the risk of cumulative mortality in patients with IPF undergoing unilateral LTx.",2019,"Cox regression models showed that the PRP group had a reduced 54.0% (hazard ratio = 0.464, 95% confidence interval 0.222-0.970, p = 0.041) risk of death.","['patients with IPF undergoing unilateral LTx', '89 patients who underwent LTx due to IPF', 'patients with idiopathic pulmonary fibrosis undergoing lung transplantation', 'patients with idiopathic pulmonary fibrosis (IPF) undergoing lung transplant (LTx']","['pulmonary rehabilitation program (PRP', 'Pulmonary rehabilitation', 'PRP PRP completion']","['survival', 'IMV', 'cumulative mortality', 'Survival', 'invasive mechanical ventilation (IMV), length of stay (LOS) in intensive care unit (ICU) and in hospital']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",89.0,0.0400954,"Cox regression models showed that the PRP group had a reduced 54.0% (hazard ratio = 0.464, 95% confidence interval 0.222-0.970, p = 0.041) risk of death.","[{'ForeName': 'Juliessa', 'Initials': 'J', 'LastName': 'Florian', 'Affiliation': 'Postgraduate Program in Pulmonology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Watte', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil. g.watte@gmail.com.'}, {'ForeName': 'Paulo José Zimermann', 'Initials': 'PJZ', 'LastName': 'Teixeira', 'Affiliation': 'Pulmonary Rehabilitation Program, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Altmayer', 'Affiliation': 'Medical Imaging Research Laboratory, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Sadi Marcelo', 'Initials': 'SM', 'LastName': 'Schio', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Letícia Beatriz', 'Initials': 'LB', 'LastName': 'Sanchez', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Douglas Zaione', 'Initials': 'DZ', 'LastName': 'Nascimento', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Spencer Marcantonio', 'Initials': 'SM', 'LastName': 'Camargo', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Fabiola Adélia', 'Initials': 'FA', 'LastName': 'Perin', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'José de Jesus', 'Initials': 'JJ', 'LastName': 'Camargo', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Felicetti', 'Affiliation': 'Department of Lung Transplantation, Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'José da Silva', 'Initials': 'JDS', 'LastName': 'Moreira', 'Affiliation': 'Postgraduate Program in Pulmonology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Scientific reports,['10.1038/s41598-019-45828-2'] 404,32240196,Metabolic phenotyping by treatment modality in obese women with gestational diabetes suggests diverse pathophysiology: An exploratory study.,"BACKGROUND AND PURPOSE Excess insulin resistance is considered the predominant pathophysiological mechanism in obese women who develop gestational diabetes (GDM). We hypothesised that obese women requiring differing treatment modalities for GDM may have diverse underlying metabolic pathways. METHODS In this secondary analysis of the UK pregnancies Better Eating and Activity Trial (UPBEAT) we studied women from the control arm with complete biochemical data at three gestational time points; at 15-18+6 and 27-28+6 weeks (before treatment), and 34-36+0 weeks (after treatment). A total of 89 analytes were measured (plasma/serum) using a targeted nuclear magnetic resonance (NMR) platform and conventional assays. We used linear regression with appropriate adjustment to model metabolite concentration, stratified by treatment group. MAIN FINDINGS 300 women (median BMI 35kg/m2; inter quartile range 32.8-38.2) were studied. 71 developed GDM; 28 received dietary treatment only, 20 metformin, and 23 received insulin. Prior to the initiation of treatment, multiple metabolites differed (p<0.05) between the diet and insulin-treated groups, especially very large density lipoprotein (VLDL) and high density lipoprotein (HDL) subclasses and constituents, with some differences maintained at 34-36 weeks' gestation despite treatment. Gestational lipid profiles of the diet treatment group were indicative of a lower insulin resistance profile, when compared to both insulin-treated women and those without GDM. At 28 weeks' the diet treatment group had lower plasma fasting glucose and insulin than women treated with insulin, yet similar to those without GDM, consistent with a glycaemic mechanism independent of insulin resistance. CONCLUSIONS/INTERPRETATION This exploratory study suggests that GDM pathophysiological processes may differ amongst obese women who require different treatment modalities to achieve glucose control and can be revealed using metabolic profiling.",2020,"At 28 weeks' the diet treatment group had lower plasma fasting glucose and insulin than women treated with insulin, yet similar to those without GDM, consistent with a glycaemic mechanism independent of insulin resistance. ","['300 women (median BMI 35kg/m2; inter quartile range 32.8-38.2) were studied', 'obese women', 'obese women with gestational diabetes suggests diverse pathophysiology', 'obese women who develop gestational diabetes (GDM']","['metformin, and 23 received insulin']","['large density lipoprotein (VLDL) and high density lipoprotein (HDL) subclasses and constituents', 'UPBEAT', 'Gestational lipid profiles', 'plasma fasting glucose and insulin', 'insulin resistance profile']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",300.0,0.0877926,"At 28 weeks' the diet treatment group had lower plasma fasting glucose and insulin than women treated with insulin, yet similar to those without GDM, consistent with a glycaemic mechanism independent of insulin resistance. ","[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Shahina', 'Initials': 'S', 'LastName': 'Begum', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Matias C', 'Initials': 'MC', 'LastName': 'Vieira', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Lawlor', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Dharmintra', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0230658'] 405,31826241,Impact of NPM1/FLT3-ITD genotypes defined by the 2017 European LeukemiaNet in patients with acute myeloid leukemia.,"Patients with acute myeloid leukemia (AML) harboring FLT3 internal tandem duplications (ITDs) have poor outcomes, in particular AML with a high (≥0.5) mutant/wild-type allelic ratio (AR). The 2017 European LeukemiaNet (ELN) recommendations defined 4 distinct FLT3-ITD genotypes based on the ITD AR and the NPM1 mutational status. In this retrospective exploratory study, we investigated the prognostic and predictive impact of the NPM1/FLT3-ITD genotypes categorized according to the 2017 ELN risk groups in patients randomized within the RATIFY trial, which evaluated the addition of midostaurin to standard chemotherapy. The 4 NPM1/FLT3-ITD genotypes differed significantly with regard to clinical and concurrent genetic features. Complete ELN risk categorization could be done in 318 of 549 trial patients with FLT3-ITD AML. Significant factors for response after 1 or 2 induction cycles were ELN risk group and white blood cell (WBC) counts; treatment with midostaurin had no influence. Overall survival (OS) differed significantly among ELN risk groups, with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate-, and adverse-risk groups, respectively (P < .001). A multivariate Cox model for OS using allogeneic hematopoietic cell transplantation (HCT) in first complete remission as a time-dependent variable revealed treatment with midostaurin, allogeneic HCT, ELN favorable-risk group, and lower WBC counts as significant favorable factors. In this model, there was a consistent beneficial effect of midostaurin across ELN risk groups.",2020,"Overall survival (OS) differed significantly between ELN risk groups with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate- and adverse-risk groups, respectively (P<0.001).","['318 of 549 trial patients with FLT3-ITD AML', '2017 European LeukemiaNet (ELN) recommendations defined four distinct FLT3-ITD genotypes based on the ITD-AR and the NPM1 mutational status', 'Patients with AML harboring FLT3 internal tandem duplications (ITD', 'patients with acute myeloid leukemia']","['allogeneic hematopoietic-cell transplantation (HCT', 'NPM1/FLT3-ITD', 'midostaurin to standard chemotherapy']","['5-year OS probabilities', 'Overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0364359,"Overall survival (OS) differed significantly between ELN risk groups with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate- and adverse-risk groups, respectively (P<0.001).","[{'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Jahn', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Panina', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Gambietz', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Medicine and Comprehensive Cancer Research Center, University of Chicago, Chicago, IL.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Prior', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marcucci', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata,"" Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Ottone', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata,"" Rome, Italy.'}, {'ForeName': 'Josep F', 'Initials': 'JF', 'LastName': 'Nomdedeu', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB-Santpau and Jose Carreras Leukemia Research Institutes, Autonomus University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Klisovic', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Clinical Hematology, The Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB-Santpau and Jose Carreras Leukemia Research Institutes, Autonomus University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Instituto de Investigación Sanitaria La Fe, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brandwein', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'de Witte', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Joop H', 'Initials': 'JH', 'LastName': 'Jansen', 'Affiliation': 'Laboratory Hematology, Deptartment of Laboratory Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Department of Hematology, Oncology, and Hemostasis, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Medeiros', 'Affiliation': 'Division of Hematology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Department of Medicine, Hematology/Oncology, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata,"" Rome, Italy.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Gathmann', 'Affiliation': 'Novartis Pharmaceuticals, Basel, Switzerland; and.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novartis Pharmaceuticals, Basel, Switzerland; and.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}]",Blood,['10.1182/blood.2019002697'] 406,31984443,"Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial.","AIMS/HYPOTHESIS A head-to-head randomised trial was conducted to evaluate hypoglycaemia safety with insulin degludec 200 U/ml (degludec U200) and insulin glargine 300 U/ml (glargine U300) in individuals with type 2 diabetes treated with basal insulin. METHODS This randomised (1:1), open-label, treat-to-target, multinational trial included individuals with type 2 diabetes, aged ≥18 years with HbA 1c ≤80 mmol/mol (9.5%) and BMI ≤45 kg/m 2 . Participants were previously treated with basal insulin with or without oral glucose-lowering drugs (excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk. Both degludec U200 and glargine U300 were similarly titrated to a fasting blood glucose target of 4.0-5.0 mmol/l. Endpoints were assessed during a 36 week maintenance period and a total treatment period up to 88 weeks. There were three hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose [<3.1 mmol/l] with symptoms); (2) nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms, between 00:01 and 05:59 h); and (3) severe hypoglycaemia. The primary endpoint was the number of overall symptomatic hypoglycaemic events in the maintenance period. Secondary hypoglycaemia endpoints included the number of nocturnal symptomatic events and number of severe hypoglycaemic events during the maintenance period. RESULTS Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the glargine U300 arm completed the trial (87.3% and 87.8% completed on treatment, respectively). Baseline characteristics were comparable between the two treatment arms. For the primary endpoint, the rate of overall symptomatic hypoglycaemia was not significantly lower with degludec U200 vs glargine U300 (rate ratio [RR] 0.88 [95% CI 0.73, 1.06]). As there was no significant difference between treatments for the primary endpoint, the confirmatory testing procedure for superiority was stopped. The pre-specified confirmatory secondary hypoglycaemia endpoints were analysed using pre-specified statistical models but were now considered exploratory. These endpoints showed a lower rate of nocturnal symptomatic hypoglycaemia (RR 0.63 [95% CI 0.48, 0.84]) and severe hypoglycaemia (RR 0.20 [95% CI 0.07, 0.57]) with degludec U200 vs glargine U300. CONCLUSIONS/INTERPRETATION There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period. The rates of nocturnal symptomatic and severe hypoglycaemia were nominally significantly lower with degludec U200 during the maintenance period compared with glargine U300. TRIAL REGISTRATION ClinicalTrials.gov NCT03078478 FUNDING: This trial was funded by Novo Nordisk (Bagsvaerd, Denmark).",2020,There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period.,"['individuals with type 2 diabetes treated with basal insulin', 'excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk', 'insulin-treated patients with type 2 diabetes', 'individuals with type 2 diabetes, aged ≥18\xa0years with HbA 1c ≤80\xa0mmol/mol (9.5%) and BMI ≤45\xa0kg/m 2 ', 'Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the']","['basal insulin with or without oral glucose-lowering drugs', 'insulin degludec versus insulin glargine U300', 'glargine', 'insulin degludec 200\xa0U/ml (degludec U200) and insulin glargine 300\xa0U/ml (glargine U300']","['nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms', 'number of overall symptomatic hypoglycaemic events', 'fasting blood glucose', 'severe hypoglycaemia', 'hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose', 'hypoglycaemia safety', 'Risk of hypoglycaemia', 'rates of nocturnal symptomatic and severe hypoglycaemia', 'rate of overall symptomatic hypoglycaemia', 'rate of nocturnal symptomatic hypoglycaemia', 'number of nocturnal symptomatic events and number of severe hypoglycaemic events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4704833', 'cui_str': 'Secretagogues'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1609.0,0.398525,There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period.,"[{'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, 10140 Campus Point Drive, Suite 200, San Diego, CA, 92121, USA. Philis-Tsimikas.Athena@scrippshealth.org.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Klonoff', 'Affiliation': 'Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes and Endocrinology, Brampton, ON, Canada.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, Division of Endocrinology & Metabolism, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lone N', 'Initials': 'LN', 'LastName': 'Troelsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Ladelund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-019-05080-9'] 407,32269109,Scrambler therapy improves pain in neuromyelitis optica: A randomized controlled trial.,"OBJECTIVE To determine whether Scrambler therapy is an effective, acceptable, and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD) and to explore the effect of Scrambler therapy on co-occurring symptoms. METHODS We conducted a randomized single-blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression, and sleep disturbance were assessed at baseline, at the end of treatment, and at the 30- and 60-day follow-up. RESULTS Twenty-two patients (11 per arm) were enrolled in and completed this trial. The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not affected in the sham arm. The safety profiles were similar between groups. CONCLUSIONS Scrambler therapy is an effective, feasible, and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety. CLINICALTRIALSGOV IDENTIFIER NCT03452176. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that Scrambler therapy significantly reduces pain in patients with NMOSD and persistent central neuropathic pain.",2020,"The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm.","['patients with NMOSD and persistent central neuropathic pain', 'Twenty-two patients (11 per arm) were enrolled in and completed this trial', 'patients with neuromyelitis optica spectrum disorder (NMOSD', 'patients with NMOSD', 'patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays']",['Scrambler therapy'],"['anxiety', 'Pain severity, pain interference, anxiety, depression, and sleep disturbance', 'central neuropathic pain', 'median NRS score', 'Depression', 'depression and anxiety', 'pain', 'median baseline numeric rating scale (NRS) pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",22.0,0.37789,"The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm.","[{'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Mealy', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA. mmealy1@jhmi.edu.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Kozachik', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Cook', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Totonis', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ruth Andrea', 'Initials': 'RA', 'LastName': 'Salazar', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jerilyn K', 'Initials': 'JK', 'LastName': 'Allen', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Nolan', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Neurology,['10.1212/WNL.0000000000009370'] 408,32269170,"Correction: Regular, sustained-release morphine for chronic breathlessness: a multicentre, double-blind, randomised, placebo-controlled trial .",,2020,,['chronic breathlessness'],"['placebo', 'Correction: Regular, sustained-release morphine']",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.761976,,[],Thorax,['10.1136/thoraxjnl-2019-213681corr1'] 409,32271690,Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial - A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy.,"PURPOSE We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer. MATERIALS AND METHODS Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life. RESULTS Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6-months compared to baseline (p<0.05). Continent diversion (versus non-continent) was associated with worse FACT-BL-cys score at 3-s (p<0.01) but not at 6-months, and the SF-8 physical component was better in continent-diversion patients at 6-months (p=0.019). CONCLUSIONS Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling.",2020,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,['Patients with Bladder Cancer'],"['Robot versus Open Radical Cystectomy', 'Robotic Cystectomy (RAZOR', 'robotic and open radical cystectomy']","['worse FACT-BL-cys score', 'SF-8 physical component', 'Continent diversion', 'SF-8 sores', 'FACT-VCI subscale or composite score', 'Health-Related Quality of Life', 'health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",302.0,0.140481,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,"[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Becerra', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Venkatramani', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Isildinha M', 'Initials': 'IM', 'LastName': 'Reis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Nachiketh', 'Initials': 'N', 'LastName': 'Soodana-Prakash', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Sanoj', 'Initials': 'S', 'LastName': 'Punnen', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Gonzalgo', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Shyamal', 'Initials': 'S', 'LastName': 'Raolji', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Castle', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Woods', 'Affiliation': 'Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alon Z', 'Initials': 'AZ', 'LastName': 'Weizer', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Tollefson', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia.'}, {'ForeName': 'Norm D', 'Initials': 'ND', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shabsigh', 'Affiliation': 'Department of Urology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Barocas', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Quek', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Atreya', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Dipen J', 'Initials': 'DJ', 'LastName': 'Parekh', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}]",The Journal of urology,['10.1097/JU.0000000000001029'] 410,32236104,"Effectiveness of peer counseling, social engagement, and combination interventions in improving depressive symptoms of community-dwelling Filipino senior citizens.","INTRODUCTION Little is known about community-based interventions for geriatric depression in low-resource settings. This study assessed the effectiveness of 3-month-duration interventions with peer counseling, social engagement, and combination vs. control in improving depressive symptoms of community-dwelling Filipino senior citizens. METHODS We conducted an open (non-blinded), non-randomized trial of senior citizens at risk for depression. Three different 3-month interventions included peer counseling (n = 65), social engagement (n = 66), and combination (n = 65) were compared with the control group (n = 68). We assessed geriatric depression, psychological resilience, perceived social support, loneliness, and working alliance scores at baseline and three months after the intervention. This trial was registered with ClinicalTrials.gov, identifier: NCT03989284. RESULTS Geriatric depression score over three months significantly improved in all intervention groups (control as reference). Significant improvements were also seen in psychological resilience and social support. Not all interventions, however, significantly improved the loneliness score. The combination group showed the largest effect of improving depressive symptoms (d = -1.33) whereas the social engagement group showed the largest effect of improving psychological resilience (d = 1.40), perceived social support (d = 1.07), and loneliness (d = -0.36) among senior citizens. CONCLUSION At the community level, peer counseling, social engagement, and combination interventions were effective in improving depressive symptoms, psychological resilience, and social support among Filipino senior citizens. This study shows that it is feasible to identify senior citizens at risk for depression in the community and intervene effectively to improve their mental health. Further studies are required to target loneliness and investigate the long-term benefits of the interventions. CLINICAL TRIAL ClinicalTrials.gov: NCT03989284.",2020,"At the community level, peer counseling, social engagement, and combination interventions were effective in improving depressive symptoms, psychological resilience, and social support among Filipino senior citizens.","['community-dwelling Filipino senior citizens', 'senior citizens at risk for depression']","['peer counseling, social engagement, and combination vs. control', 'peer counseling (n = 65), social engagement', 'peer counseling, social engagement, and combination interventions']","['depressive symptoms', 'psychological resilience', 'geriatric depression, psychological resilience, perceived social support, loneliness, and working alliance scores', 'depressive symptoms, psychological resilience, and social support', 'loneliness score', 'Geriatric depression score', 'psychological resilience and social support', 'perceived social support']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",65.0,0.0461006,"At the community level, peer counseling, social engagement, and combination interventions were effective in improving depressive symptoms, psychological resilience, and social support among Filipino senior citizens.","[{'ForeName': 'Rogie Royce', 'Initials': 'RR', 'LastName': 'Carandang', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shibanuma', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Kiriya', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Karen Rose', 'Initials': 'KR', 'LastName': 'Vardeleon', 'Affiliation': 'Childfam-Possibilities Psychosocial Services Co., Quezon City, Philippines.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Asis', 'Affiliation': 'Department of Global Studies, Faculty of Liberal Arts, Sophia University, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murayama', 'Affiliation': 'Institute of Gerontology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masamine', 'Initials': 'M', 'LastName': 'Jimba', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0230770'] 411,32035124,Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.,"People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.",2020,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"['people living with HIV', 'People living with HIV (PWH']","['ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation', 'ABCS']",['change in ASCVD risk'],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0702008,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"[{'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Williams', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Tobin', 'Affiliation': 'Clinical Directors Network (CDN), Community-Engaged Research, The Rockefeller University Center for Clinical and Translational Science, New York, NY.'}, {'ForeName': 'Amneris Esther', 'Initials': 'AE', 'LastName': 'Luque', 'Affiliation': 'Infectious Diseases and Geographic Medicine, HIV Program at Parkland Health and Hospital System, Community Prevention and Intervention Unit, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Mechelle', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Carroll', 'Affiliation': 'Department of Family Medicine, University of Colorado, Aurora, CO.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cassells', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Tameir', 'Initials': 'T', 'LastName': 'Holder', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fiscella', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY. Electronic address: Kevin_fiscella@urmc.rochester.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.02.003'] 412,32268328,Effect of Lifestyle Interventions in Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children.,"INTRODUCTION Maternal obesity and excessive gestational weight gain are related to adverse outcomes in women and children. Lifestyle interventions during pregnancy showed positive effects on decreasing weight gain during pregnancy, but effects on offspring's health and wellbeing are unclear. We aimed to assess the effect of lifestyle intervention programmes on offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures. METHODS Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who were randomly assigned to 3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group) and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2) were used as an additional control group in this analysis. When the children were between 3 and 7 years old, anthropometric and cardiovascular measurements were conducted and various questionnaires about offspring mental health, temperament and eating habits were filled out. RESULTS Children of mothers who received a brochure-based lifestyle intervention programme showed significantly less surgency/extraversion compared to children of mothers who received routine antenatal care (contrast estimate = -0.36, SE = 0.15, p = 0.02, 95% CI [-6.66, -0.06]) and prenatal lifestyle intervention sessions (contrast estimate = -0.46, SE = 0.14, p < 0.01, 95% CI [-0.74, -0.18]) after adjusting for child's age, sex, offspring birth weight and mother's educational level. The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics. Children of mothers with a normal BMI showed less emotional problems (F(1, 156) = 5.42, p = 0.02) and internalizing (F(1, 156) = 3.04, p = 0.08) and externalizing problems (F(1, 156) = 6.10, p = 0.02) when compared to children of mothers in the obese group. DISCUSSION/CONCLUSION The results suggest that a brochure-based lifestyle intervention programme can affect the offspring temperament. Future follow-up studies need to investigate how these temperament-related effects may influence obesity development later in life.",2020,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","['and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2', 'Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who', 'Children of mothers with a normal BMI', 'Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children', 'women and children']","['Lifestyle Interventions', 'brochure-based lifestyle intervention programme', 'lifestyle intervention programmes', '3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group']","['prenatal lifestyle intervention sessions', 'offspring mental health, eating habits and anthropometric and cardiovascular characteristics', 'offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures', 'surgency/extraversion', 'externalizing problems', 'emotional problems', 'weight gain']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0015382', 'cui_str': 'Extroversion, Psychological'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.064488,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","[{'ForeName': 'Marijke Anne Katrien Alberta', 'Initials': 'MAKA', 'LastName': 'Braeken', 'Affiliation': 'Research Unit Resilient People, Faculty of Health and Social Work, University Colleges Leuven-Limburg, Diepenbeek, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium, annick.bogaerts@kuleuven.be.'}]",Obesity facts,['10.1159/000506690'] 413,32100192,InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design.,"INTRODUCTION Suboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro- and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need. METHODS InRange is a multicentre, randomised, active-controlled, parallel-group, 12-week, open-label, phase 4, comparative study. Adults with T1D will be randomised to receive once-daily Gla-300 or IDeg-100 by subcutaneous injection in the morning. Following an 8-week titration period, CGM data will be collected over 20 consecutive days. PLANNED OUTCOMES The primary objective is to demonstrate that Gla-300 is noninferior to IDeg-100 in terms of glycaemic control [time-in-range ≥ 70 to ≤ 180 mg/dL (≥ 3.9 to ≤ 10 mmol/L)] and variability, as assessed using CGM, in adults with T1D. The results are expected to help confirm the utility of CGM in clinical practice in this population and provide insight into its application as an outcome measure in clinical practice. TRIAL REGISTRATION NCT04075513.",2020,"Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions.","['Adults with T1D', 'adults with T1D', 'Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design', 'people with type 1 diabetes (T1D']","['CGM', 'Gla-300', 'U/mL', 'Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL', 'Continuous glucose monitoring (CGM']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]",[],,0.065702,"Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions.","[{'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""UMC-University Children's Hospital, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. tadej.battelino@mf.uni-lj.si.""}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Bosnyak', 'Affiliation': 'Sanofi S.A., Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Children\'s and Youth Hospital ""Auf Der Bult"", Hannover, Germany.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi S.A., Paris, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Edelman', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Pilorget', 'Affiliation': 'Sanofi S.A., Paris, France.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Renard', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center at Park Nicollet, Minneapolis, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00781-6'] 414,32105889,Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial.,"INTRODUCTİON: Currently, the management of cholelithiasis in combination with choledocholithiasis involves endoscopic retrograde cholangiopancreatography (ERCP) followed by cholecystectomy. However, recently, early surgical approaches are becoming more common, even in the treatment of acute cholecystitis. METODS: Patients diagnosed as having cholelithiasis and choledocholithiasis between October 2017 and May 2019 were prospectively enrolled in the study in a randomized manner. Patients undergoing ERCP + LC (laparoscopic cholecystectomy) in the same session were assigned to group A (n = 39), those undergoing ERCP + LC in the same hospitalization period were assigned to group B (n = 43), and patients who underwent delayed cholecystectomy after ERCP were included in group C (n = 37). RESULT: A total of 119 patients (47 females and 72 males) were included in the study and divided into three groups. Statistical comparisons of the study groups showed a significant difference between the three groups in terms of the length of hospital stay (days) and total cost (p < 0.001). The total cost was significantly higher for patients in group C in comparison with those in groups A and B (p < 0.001). Compared with patients in groups A and B, there was statistically significant difference in the length of hospital stay for patients in group C (p < 0.001). CONCLUSİONS: Single-stage ERCP plus LC is a safe and feasible strategy for the management of cholelithiasis and choledocholithiasis, offering advantages of cost, shorter hospital stay, and total anesthesia time. The major advantage of ERCP and LC performed in the same session and during the same hospitalization is the absence of the risk of recurrent episodes of acute cholecystitis, which occur with delayed cholecystectomy.",2020,The total cost was significantly higher for patients in group C in comparison with those in groups A and B (p<0.001).,"['laparoscopic cholecystectomy six-to-eight weeks later', 'Patients diagnosed as having cholelithiasis and choledocholithiasis between October 2017 and May 2019 were prospectively enrolled in the study in a randomized manner', '119 patients (47 females and 72 males']","['choledocholithiasis involves endoscopic retrograde cholangiopancreatography (ERCP', 'ERCP + LC (laparoscopic cholecystectomy', 'single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP', 'ERCP + LC', 'delayed cholecystectomy after ERCP', 'Single-stage ERCP plus LC']","['length of hospital stay (days) and total cost', 'safety and efficacy', 'length of hospital stay', 'total cost']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008350', 'cui_str': 'Cholelithiasis'}, {'cui': 'C0701818', 'cui_str': 'Choledocholithiasis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0701818', 'cui_str': 'Choledocholithiasis'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",119.0,0.0355564,The total cost was significantly higher for patients in group C in comparison with those in groups A and B (p<0.001).,"[{'ForeName': 'Bahtiyar', 'Initials': 'B', 'LastName': 'Muhammedoğlu', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgeon, Necip Fazil City Hospital, Kahramanmaras, Turkey. Electronic address: baha197647@gmail.com.'}, {'ForeName': 'Ilhami Taner', 'Initials': 'IT', 'LastName': 'Kale', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Department of General Surgery, Kahramanmaras, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.02.021'] 415,32156187,Acute coordinative exercise ameliorates general and food-cue related cognitive function in obese adolescents.,"Whether the acute coordinative exercise could affect the inhibitory control and food-cue related attention in obese adolescents remains understudied. Therefore, this study used the Stroop test and the food-cue related Stroop test to explore the impacts of 20 min of acute coordinative exercise on the cognitive tests involving inhibitory control and attentional bias towards food-cue related stimuli, respectively, in obese adolescents. Thirty-eight obese adolescents (mean age = 14.63 ± 0.69 years) were equally divided into exercise and control groups. The cognitive tests (i.e., the Stroop test and the food-cue related Stroop test) and hunger scores were conducted and assessed before and after an intervention. The exercise group had significantly larger negative pre-post response time difference in the congruent (-1.04 ± 0.29 ms) and incongruent (-5.76 ± 1.66 ms) conditions of the Stroop test than the control group ( p s < 0.01), and a smaller post-interference (1.13 ± 0.14) than the pre-interference (1.31 ± 0.14, p = 0.04). Moreover, a significantly larger negative pre-post response time difference on the food-cue related Stroop test was observed in the exercise group (-4.42 ± 7.20 ms) than the control group (1.76 ± 8.37 ms, p = 0.02). Collectively, an acute coordinative exercise session could induce superior inhibitory control and less attentional bias towards food-cue related stimuli in obese adolescents.",2020,"1.66 ms) conditions of the Stroop test than the control group ( p s < 0.01), and a smaller post-interference (1.13 ± 0.14) than the pre-interference (1.31 ± 0.14, p = 0.04).","['Thirty-eight obese adolescents (mean age\xa0=\xa014.63\xa0±\xa00.69\xa0years', 'obese adolescents']",['Acute coordinative exercise ameliorates general and food-cue'],"['larger negative pre-post response time difference', 'food-cue related Stroop test', 'Stroop test and the food-cue related Stroop test) and hunger scores']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",38.0,0.0230097,"1.66 ms) conditions of the Stroop test than the control group ( p s < 0.01), and a smaller post-interference (1.13 ± 0.14) than the pre-interference (1.31 ± 0.14, p = 0.04).","[{'ForeName': 'Ligong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan, Republic of China.'}, {'ForeName': 'Chien-Heng', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Republic of China.'}, {'ForeName': 'Jen-Hao', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan, Republic of China.'}, {'ForeName': 'Feng-Tzu', 'Initials': 'FT', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Sport, Leisure and Hospitality Management, National Taiwan Normal University, Taipei, Republic of China.'}, {'ForeName': 'Jui-Ti', 'Initials': 'JT', 'LastName': 'Nien', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan, Republic of China.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""School of Kinesiology, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Republic of China.'}]",Journal of sports sciences,['10.1080/02640414.2020.1737386'] 416,32166619,"Model-based Prediction of the Long-term Glucose-Lowering Effects of Ipragliflozin, a Selective Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor, in Patients with Type 2 Diabetes Mellitus.","INTRODUCTION Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors inhibit the reabsorption of glucose from the kidneys and increase urinary glucose excretion (UGE), thereby lowering the blood glucose concentration in people suffering from type 1 and type 2 diabetes mellitus (T2DM). In a previous study, we reported a pharmacokinetics/pharmacodynamics model to estimate individual change in UGE (ΔUGE), which is a direct pharmacological effect of SGLT2 inhibitors. In this study, we report our enhancement of the previous model to predict the long-term effects of ipragliflozin on clinical outcomes in patients with T2DM. METHODS The time course of fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) in patients with T2DM following ipragliflozin treatment that had been observed in earlier clinical trials was modeled using empirical models combined with the maximum drug effect (E max ) model and disease progression model. As a predictive factor of drug effect, estimated ΔUGE was introduced into the E max model, instead of ipragliflozin exposure. The developed models were used to simulate the time course of FPG and HbA1c following once-daily treatment with placebo or ipragliflozin at doses of 12.5, 25, 50 and 100 mg, and the changes at 52 weeks at the approved dose of 50 mg were summarized by renal function category. RESULTS The developed models that included UGE as a dependent variable of response were found to well describe observed time courses in FPG and HbA1c. Baseline blood glucose level and renal function had significant effects on the glucose-lowering effect of ipragliflozin, and these models enabled quantification of these impacts on clinical outcomes. Simulated median changes in HbA1c in T2DM patients with mild and moderate renal impairment were 25 and 63% lower, respectively, than those in T2DM patients with normal renal function. These results are consistent with the observed clinical data from a previous renal impairment study. CONCLUSIONS Empirical models established based on the effect of UGE well predicted the renal function-dependent long-term glucose-lowering effects of ipragliflozin in patients with T2DM.",2020,"Baseline blood glucose level and renal function had significant effects on the glucose-lowering effect of ipragliflozin, and these models enabled quantification of these impacts on clinical outcomes.","['patients with T2DM', 'Patients with Type 2 Diabetes Mellitus', 'patients with T2DM following', 'people suffering from type 1 and type 2 diabetes mellitus (T2DM']","['Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors', 'ipragliflozin', 'placebo or ipragliflozin', 'Ipragliflozin, a Selective Sodium-Glucose Cotransporter 2']","['Baseline blood glucose level and renal function', 'time course of fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c', 'moderate renal impairment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",,0.036441,"Baseline blood glucose level and renal function had significant effects on the glucose-lowering effect of ipragliflozin, and these models enabled quantification of these impacts on clinical outcomes.","[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. masako.saito@astellas.com.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kaibara', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kadokura', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Kazuta', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Ueyama', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00785-2'] 417,32008913,Effect of fatty fish or nut consumption on concentrations of persistent organic pollutants in overweight or obese men and women: A randomized controlled clinical trial.,"BACKGROUND AND AIMS While excess energy intake and physical inactivity constitute the obvious causes of body fat accumulation, persistent organic pollutants (POPs) are novel factors that have been linked to cardiometabolic disorders. Major sources of POPs are animal fats including fatty fish. Given the putative protective effects of fish on cardiovascular disease, we explored whether high consumption of fatty fish increased serum concentrations of POPs. METHODS AND RESULTS Men and women aged 35-70 years with body mass index between 25 and 38 kg/m 2 and at least 1 cardiometabolic component were randomized to high intakes of fatty fish (mostly farmed salmon, ∼630 g/week; n = 45), high intakes of nuts (∼200 g/week; n = 42) or a control group following their usual diet but restricting fatty fish and nuts for 6 months (n = 44). Concentrations of 15 POPs (5 organochlorinated compounds, 2 dioxin-like polychlorinated biphenyls and 8 non-dioxin-like polychlorinated biphenyls) and cardiometabolic risk factors were measured at baseline and end of the study. Results showed that changes in concentrations of individual and classes of POPs did not differ between the dietary groups and controls (p > 0.05). Among cardiometabolic risk factors HDL-cholesterol increased in the fatty fish group compared to controls (+0.10 mmol/L, CI (0.05-0.20); p = 0.005) while no changes were observed in the group consuming nuts. CONCLUSION Fatty fish consumption for 6 months did not increase the serum concentrations of POPs in individuals with overweight or obesity and metabolic risk. While this finding appears reassuring regarding short-term intakes of farmed salmon, long term variations in POPs in adipose stores require further study.",2020,"Among cardiometabolic risk factors HDL-cholesterol increased in the fatty fish group compared to controls (+0.10 mmol/L, CI (0.05-0.20); p = 0.005) while no changes were observed in the group consuming nuts. ","['individuals with overweight or obesity and metabolic risk', 'overweight or obese men and women', 'Men and women aged 35-70 years with body mass index between 25 and 38\xa0kg/m 2 and at least 1 cardiometabolic component']","['fatty fish or nut consumption', 'Fatty fish consumption', 'high intakes of fatty fish (mostly farmed salmon, ∼630\xa0g/week; n\xa0=\xa045), high intakes of nuts (∼200\xa0g/week; n\xa0=\xa042) or a control group following their usual diet but restricting fatty fish and nuts']","['serum concentrations of POPs', 'cardiometabolic risk factors HDL-cholesterol', 'concentrations of individual and classes of POPs', 'cardiometabolic risk factors']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557759', 'cui_str': 'Farmland'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",,0.0870772,"Among cardiometabolic risk factors HDL-cholesterol increased in the fatty fish group compared to controls (+0.10 mmol/L, CI (0.05-0.20); p = 0.005) while no changes were observed in the group consuming nuts. ","[{'ForeName': 'Sasa', 'Initials': 'S', 'LastName': 'Dusanov', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway. Electronic address: sasdus@ous-hf.no.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Svendsen', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway; Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Ruzzin', 'Affiliation': 'Department of Biological Sciences, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kiviranta', 'Affiliation': 'National Institute for Health and Welfare, Department of Health Security, Kuopio, Finland.'}, {'ForeName': 'Hanne L', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway; Department of Chronic Diseases and Ageing, Norwegian Instiute of Public Health, Oslo, Norway.'}, {'ForeName': 'Tor O', 'Initials': 'TO', 'LastName': 'Klemsdal', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Tonstad', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.11.006'] 418,31235748,Effects of Relaxing Music on Healthy Sleep.,"Sleep is vital for human health and wellbeing, and sleep disturbances are comorbid to many mental and physiological disorders. Music consistently improves subjective sleep quality, whereas results for objective sleep parameters diverge. These inconsistencies might be due to inter-individual differences. Here, 27 female subjects listened to either music or a control text before a 90 minutes nap in a within-subjects design. We show that music improved subjective sleep quality as compared to the text condition. In all participants, music resulted in a reduced amount of sleep stage N1 during the nap. In addition, music significantly increased the amount of slow-wave sleep (SWS) and increased the low/high frequency power ratio. However, these effects occurred only in participants with a low suggestibility index. We conclude that listening to music before a nap can improve subjective and objective sleep parameters in some participants.",2019,"In all participants, music resulted in a reduced amount of sleep stage N1 during the nap.","['27 female subjects', 'Healthy Sleep']","['Relaxing Music', 'listened to either music or a control text']","['subjective and objective sleep parameters', 'subjective sleep quality', 'amount of slow-wave sleep (SWS', 'sleep stage N1']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}]",27.0,0.0267106,"In all participants, music resulted in a reduced amount of sleep stage N1 during the nap.","[{'ForeName': 'Maren Jasmin', 'Initials': 'MJ', 'LastName': 'Cordi', 'Affiliation': 'University of Fribourg, Department of Psychology, Division of Cognitive Biopsychology and Methods, Fribourg, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ackermann', 'Affiliation': 'University of Fribourg, Department of Psychology, Division of Cognitive Biopsychology and Methods, Fribourg, Switzerland.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Rasch', 'Affiliation': 'University of Fribourg, Department of Psychology, Division of Cognitive Biopsychology and Methods, Fribourg, Switzerland. bjoern.rasch@unifr.ch.'}]",Scientific reports,['10.1038/s41598-019-45608-y'] 419,31420830,Changes in Bone Mineral Density in Patients with Type 2 Diabetes After Different Bariatric Surgery Procedures and the Role of Gastrointestinal Hormones.,"BACKGROUND To compare changes in bone mineral density (BMD) in patients with morbid obesity and type 2 diabetes (T2D) a year after being randomized to metabolic gastric bypass (mRYGB), sleeve gastrectomy (SG), and greater curvature plication (GCP). We also analyzed the association of gastrointestinal hormones with skeletal metabolism. METHODS Forty-five patients with T2D (mean BMI 39.4 ± 1.9 kg/m 2 ) were randomly assigned to mRYGB, SG, or GCP. Before and 12 months after surgery, anthropometric, body composition, biochemical parameters, fasting plasma glucagon, ghrelin, and PYY as well as GLP-1, GLP-2, and insulin after a standard meal were determined. RESULTS After surgery, the decrease at femoral neck (FN) was similar but at lumbar spine (LS), it was greater in the mRYGB group compared with SG and GCP - 7.29 (4.6) vs. - 0.48 (3.9) vs. - 1.2 (2.7)%, p < 0.001. Osteocalcin and alkaline phosphatase increased more after mRYGB. Bone mineral content (BMC) at the LS after surgery correlated with fasting ghrelin (r = - 0.412, p = 0.01) and AUC for GLP-1 (r = - 0.402, p = 0.017). FN BMD at 12 months correlated with post-surgical fasting glucagon (r = 0.498, p = 0.04) and insulin AUC (r = 0.384, p = 0.030) and at LS with the AUC for GLP-1 in the same time period (r = - 0.335, p = 0.049). However, in the multiple regression analysis after adjusting for age, sex, and BMI, the type of surgery (mRYGB) remained the only factor associated with BMD reduction at LS and FN. CONCLUSIONS mRYGB induces greater deleterious effects on the bone at LS compared with SG and GCP, and gastrointestinal hormones do not play a major role in bone changes.",2020,"After surgery, the decrease at femoral neck (FN) was similar but at lumbar spine (LS), it was greater in the mRYGB group compared with SG and GCP - 7.29 (4.6) vs. - 0.48 (3.9) vs. - 1.2 (2.7)%, p < 0.001.","['Patients with Type 2 Diabetes', 'patients with morbid obesity and type 2 diabetes (T2D', 'Forty-five patients with T2D (mean BMI 39.4\u2009±\u20091.9\xa0kg/m 2 ']","['mRYGB, SG, or GCP', 'metabolic gastric bypass (mRYGB), sleeve gastrectomy (SG), and greater curvature plication (GCP']","['Osteocalcin and alkaline phosphatase', 'FN BMD', 'decrease at femoral neck (FN', 'bone mineral density (BMD', 'anthropometric, body composition, biochemical parameters, fasting plasma glucagon, ghrelin, and PYY as well as GLP-1, GLP-2, and insulin after a standard meal', 'insulin AUC', 'Bone Mineral Density', 'Bone mineral content (BMC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}]","[{'cui': 'C1175868', 'cui_str': 'GCP (supplement)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]","[{'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0444664', 'cui_str': 'Standard meal (finding)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}]",45.0,0.0522618,"After surgery, the decrease at femoral neck (FN) was similar but at lumbar spine (LS), it was greater in the mRYGB group compared with SG and GCP - 7.29 (4.6) vs. - 0.48 (3.9) vs. - 1.2 (2.7)%, p < 0.001.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Guerrero-Pérez', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Casajoana', 'Affiliation': ""Department of General and Gastrointestinal Surgery. Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Vaquero', 'Affiliation': ""Department of Rheumatology, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Virgili', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López-Urdiales', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hernández-Montoliu', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Pujol-Gebelli', 'Affiliation': ""Department of General and Gastrointestinal Surgery. Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Osorio', 'Affiliation': ""Department of General and Gastrointestinal Surgery. Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Alves', 'Affiliation': ""Clinical Nutrition Unit, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Perez-Maraver', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pellitero', 'Affiliation': 'Department of Endocrinology and Nutrition and Health Sciences Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vidal-Alabró', 'Affiliation': ""Instituto de Investigación Biomédica-IDIBELL,, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Fernández-Veledo', 'Affiliation': 'CIBERDEM-CIBER de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vendrell', 'Affiliation': 'CIBERDEM-CIBER de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, Barcelona, Spain. jvo@comt.es.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Vilarrasa', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, c/ Feixa Llarga s/n, 08907, L'Hospitalet de Llobregat, Barcelona, Spain. nuriavilarrasa@yahoo.es.""}]",Obesity surgery,['10.1007/s11695-019-04127-5'] 420,32267783,"The Effects of Apnea Training, Using Voluntary Breath Holds, on High Altitude Acclimation: Breathe-High Altitude Study.","Introduction: There is evidence that intermittent hypoxic exposure (IHE) may improve high altitude (HA) performance. In this study, the effects of short-term IHE through voluntary apnea training on HA-related symptoms, including acute mountain sickness (AMS), were examined for the first time. Methods: Forty healthy adults were randomized to a self-administered apnea training ( n  = 19) or control ( n  = 21 no apnea training) group before ascent to an altitude of 5100 m in the Himalayas over 14 days. The apnea training was conducted at sea level (SL) and consisted of five breath holds per day in week 1, seven in week 2, followed by 10 per day from weeks 3 to 6 and until HA exposure. Saturation of arterial oxygen (SpO 2 ), heart rate, sleep quality (Insomnia Severity Index [ISI]), rating of perceived exertion (RPE), blood pressure, and Lake Louise scores were measured at SL (in the United Kingdom) and at HA at 1400, 2700, 3400-3700, 4050-4200, 4800, and 5100-5200 m. Anxiety (Generalized Anxiety Disorder-7 [GAD-7]) scores were examined at SL, 1400, and 5100-5200 m. Results: Apnea training led to a significant increase in the mean longest breath-hold times from baseline (80.42 ± 32.49 [median 87.00] seconds) to the end of week 6 (107.02 ± 43.65 [113.00] seconds), respectively ( p  = 0.009). There was no significant difference in the prevalence of AMS (8/19 = 42.1% vs. 11/21 = 52.4%; RR 0.80; 95% confidence interval 0.41-1.57: p  = 0.80) or in GAD-7, ISI and RPE, SpO 2, heart rate, or blood pressure among the apnea versus control groups, respectively, at HA. Conclusions: Apnea training does not lessen HA-related symptoms in healthy adults traveling up to 5200 m. Larger studies using more challenging apnea protocols and at higher altitudes should be considered.",2020,"There was no significant difference in the prevalence of AMS (8/19 = 42.1% vs. 11/21 = 52.4%; RR 0.80; 95% confidence interval 0.41-1.57: p  = 0.80) or in GAD-7, ISI and RPE, SpO 2, heart rate, or blood pressure among the apnea versus control groups, respectively, at HA. ","['healthy adults', 'Forty healthy adults']","['Apnea Training', 'self-administered apnea training ( n \u2009=\u200919) or control ( n \u2009=\u200921 no apnea training) group before ascent to an altitude of 5100\u2009m in the Himalayas', 'intermittent hypoxic exposure (IHE', 'Apnea training', 'short-term IHE through voluntary apnea training']","['high altitude (HA) performance', 'HA-related symptoms, including acute mountain sickness (AMS', 'prevalence of AMS', 'mean longest breath-hold times', 'm. Anxiety (Generalized Anxiety Disorder-7 [GAD-7', 'GAD-7, ISI and RPE, SpO 2, heart rate, or blood pressure', 'Saturation of arterial oxygen (SpO 2 ), heart rate, sleep quality (Insomnia Severity Index [ISI]), rating of perceived exertion (RPE), blood pressure, and Lake Louise scores']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]","[{'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0160093,"There was no significant difference in the prevalence of AMS (8/19 = 42.1% vs. 11/21 = 52.4%; RR 0.80; 95% confidence interval 0.41-1.57: p  = 0.80) or in GAD-7, ISI and RPE, SpO 2, heart rate, or blood pressure among the apnea versus control groups, respectively, at HA. ","[{'ForeName': 'Nishma', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Surgical Sciences, Institute of Sports and Exercise Health, University College, London, United Kingdom.'}, {'ForeName': 'Kyo', 'Initials': 'K', 'LastName': 'Bye', 'Affiliation': 'Defence Medical Services, Lichfield, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Department of Surgical Sciences, Institute of Sports and Exercise Health, University College, London, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Woods', 'Affiliation': 'Defence Medical Services, Lichfield, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Hara"", 'Affiliation': 'Research Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Barlow', 'Affiliation': 'Research Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Rimmer', 'Affiliation': 'Defence Medical Services, Lichfield, United Kingdom.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Boos', 'Affiliation': 'Research Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, United Kingdom.'}]",High altitude medicine & biology,['10.1089/ham.2019.0087'] 421,30608531,Cost-effectiveness analysis of a GP- and parent-directed intervention to reduce antibiotic prescribing for children with respiratory tract infections in primary care.,"OBJECTIVES We evaluated costs and effects of the RAAK (RAtional Antibiotic use Kids) intervention (GP online training and information booklets for parents), aiming to reduce antibiotic prescribing for children with respiratory tract infection (RTI). METHODS We conducted a trial-based cost-effectiveness analysis from a societal perspective. We included children consulting the GP with RTI for whom parents kept a 2 week (cost) diary. The antibiotic prescribing rate was the percentage of children receiving an antibiotic prescription at the index consultation and during the 2 weeks of follow-up. The cost difference between the intervention and usual care groups per percentage decrease in antibiotic prescribing was calculated. Bootstrapping was used to assess uncertainty surrounding the outcomes. RESULTS Costs and effects of 153 children in the intervention group and 107 children in the usual care group were available for analysis. Antibiotic prescribing was 12% lower in the intervention group and costs were €10.27 higher in the intervention group compared with the usual care group. This resulted in an incremental cost-effectiveness ratio of €0.85 per percentage decrease in antibiotic prescribing. The probability that the intervention was more effective, but more expensive, was 53%, whereas the probability that the intervention was more effective and less expensive compared with usual care was 41%. CONCLUSIONS The online training for GPs and the information booklet for parents resulted in a decrease in antibiotic prescribing in children with RTI, at very low cost, and should therefore be considered for implementation in primary care.",2019,"The online training for GPs and the information booklet for parents resulted in a decrease in antibiotic prescribing in children with RTI, at very low cost, and should therefore be considered for implementation in primary care.","['children consulting the GP with RTI for whom parents kept a 2\u2009week (cost) diary', '153 children in the intervention group and 107 children in the usual care group', 'for parents', 'children with respiratory tract infection (RTI', 'children with respiratory tract infections in primary care', 'children with RTI']","['RAAK (RAtional Antibiotic use Kids) intervention (GP online training and information booklets', 'GP- and parent-directed intervention']","['antibiotic prescribing', 'Antibiotic prescribing', 'incremental cost-effectiveness ratio', 'antibiotic prescribing rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0649582,"The online training for GPs and the information booklet for parents resulted in a decrease in antibiotic prescribing in children with RTI, at very low cost, and should therefore be considered for implementation in primary care.","[{'ForeName': 'Anne R J', 'Initials': 'ARJ', 'LastName': 'Dekker', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Luijken', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Theo J M', 'Initials': 'TJM', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Anoukh', 'Initials': 'A', 'LastName': 'van Giessen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dky552'] 422,30597021,Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h.,"BACKGROUND The recommended adult dose of ceftaroline fosamil is 600 mg q12h by 1 h intravenous (iv) infusion for 5-14 days in complicated skin and soft tissue infection (cSSTI) and 5-7 days in community-acquired pneumonia (CAP). A dosage of 600 mg q8h by 2 h iv infusion is approved in some regions for cSSTI patients with Staphylococcus aureus infection where the ceftaroline MIC is 2 or 4 mg/L. This analysis compares the safety profiles of the q8h and q12h regimens. METHODS Safety data from six Phase III, randomized, double-blind clinical trials were collated into the q8h cSSTI pool (ceftaroline fosamil n = 506; NCT01499277) and the q12h pool {ceftaroline fosamil n = 1686; comprising five studies [two cSSTI (NCT00424190 and NCT00423657) and three CAP (NCT01371838, NCT00621504 and NCT00509106)]}. RESULTS The pattern and incidence of adverse events were similar between the q8h and q12h ceftaroline fosamil pools. Most were gastrointestinal and of mild or moderate intensity. Overall, rash intensity was similar between the q8h pool and the q12h pool. For the q8h regimen, there was a higher frequency of rash in some Asian study sites, associated with longer duration of therapy (≥7 days); most cases were mild and resolved following treatment discontinuation. No dose-related vital sign or ECG abnormalities were detected with either regimen. CONCLUSIONS The q8h regimen in cSSTI was generally well tolerated; the observed safety profile was consistent with the known safety profile of ceftaroline fosamil, reflective of the cephalosporin class and qualitatively consistent with the q12h regimen.",2019,"No dose-related vital sign or ECG abnormalities were detected with either regimen. ",[],['ceftaroline fosamil'],"['tolerated', 'safety and tolerability', 'Overall, rash intensity', 'frequency of rash', 'vital sign or ECG abnormalities']",[],"[{'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0518766'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.0604228,"No dose-related vital sign or ECG abnormalities were detected with either regimen. ","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'Pfizer, Sandwich, UK.'}, {'ForeName': 'Rienk', 'Initials': 'R', 'LastName': 'Pypstra', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Jean Li', 'Initials': 'JL', 'LastName': 'Yan', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hammond', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dky519'] 423,31235821,Tear film lipid layer increase after diquafosol instillation in dry eye patients with meibomian gland dysfunction: a randomized clinical study.,"Diquafosol promotes secretion of tear fluid and mucin at the ocular surface and is administered for treatment of dry eye (DE). Tear film lipid layer is secreted from meibomian glands and stabilizes the tear film. We recently showed that diquafosol administration increased lipid layer thickness (LLT) for up to 60 min in normal human eyes. We here evaluated tear film lipid layer in DE patients (n = 47) with meibomian gland dysfunction (MGD) before as well as 30, 60, and 90 min after diquafosol administration. One drop of artificial tears or one drop of diquafosol was applied randomly to the eyes of each patient. Diquafosol significantly increased LLT at 30 (P < 0.001) and 60 (P = 0.042) min and noninvasive tear film breakup time for at least 90 min (P < 0.001 at each assessment point). Artificial tears had no such effect. Diquafosol significantly improved the tear interferometric pattern compared with artificial tears (P < 0.001 at each assessment point). A single topical administration of diquafosol thus improved LLT and tear film stability in DE patients with MGD, suggesting that diquafosol is a potential treatment not only for aqueous-deficient DE but also for evaporative DE associated with MGD.",2019,Diquafosol significantly improved the tear interferometric pattern compared with artificial tears (P < 0.001 at each assessment point).,"['dry eye patients with meibomian gland dysfunction', 'DE patients (n\u2009=\u200947) with meibomian gland dysfunction (MGD) before as well as 30, 60, and 90\u2009min after diquafosol administration', 'DE patients with MGD']","['diquafosol', 'diquafosol instillation']","['Tear film lipid layer increase', 'LLT and tear film stability', 'lipid layer thickness (LLT', 'tear interferometric pattern', 'LLT']","[{'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1955479', 'cui_str': ""diuridine 5'-(pentahydrogen tetraphosphate) tetrasodium salt""}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1955479', 'cui_str': ""diuridine 5'-(pentahydrogen tetraphosphate) tetrasodium salt""}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0192245,Diquafosol significantly improved the tear interferometric pattern compared with artificial tears (P < 0.001 at each assessment point).,"[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Fukuoka', 'Affiliation': 'Omiya Hamada Eye Clinic, 1-169-1 Sakuragicho, Omiya-ku, Saitama, Saitama, 330-0854, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Itoh Clinic, 626-11 Minami-Nakano, Minuma-ku, Saitama, Saitama, 337-0042, Japan. ritoh@za2.so-net.ne.jp.'}]",Scientific reports,['10.1038/s41598-019-45475-7'] 424,32270774,Comparison of the effect of 1-day and 2-day low residue diets on the quality of bowel preparation before colonoscopy.,"Background/Aim Low residue diet (LRD) has a similar quality of bowel preparation with clear liquid diet before colonoscopy, but improved patient tolerance. However, the optimal LRD duration is still controversial. In this study, we have compared the effect of a 1-day LRD and 2-day LRD on the quality of bowel preparation and patient tolerance. Patients and Methods Our prospective, randomized, single-blind trial, single-blind, trial compared two dietary regimens administered the day before colonoscopy. All patients were administered PEG-ES and simethicone for bowel preparation. The primary outcome measure was bowel preparation quality. The secondary outcome measures were insertion time, withdrawal time, polyp detection rate, patient tolerance, and willingness to use the same diet for bowel preparation again. Bowel preparation quality was evaluated using the Boston bowel preparation scale (BBPS). Patient tolerance was evaluated using a hunger-comfort scale. Results There was no significant difference in bowel preparation quality between the 2 groups. The 1-day LRD group had a BBPS score of 6.48 ± 1.59 points, while the 2-day LRD group had a score of 6.42 ± 1.06 points (P > 0.05). The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores). The numbers of patients who reported that compliance as easy or very easy were 126 (78.2%) in the 1-day group versus 88 (55.0%) in the 2 day group (P < 0.05) and the numbers who were willing to use the diet again in the future were 154 (95.7%) in the 1-day group versus 131 (81.9%) in the 2 day group (P < 0.05). Conclusion LRD duration (1 day or 2 days) had no significant effect on bowel preparation quality. Patients in the 1-day LRD group had higher tolerance and satisfaction levels than patients in the 2-day LRD group. However, overall satisfaction was higher with the 1-day LRD group than with the 2-day LRD group.",2020,"The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores).",[],"['Low residue diet (LRD', '1-day and 2-day low residue diets', '1-day LRD and 2-day LRD']","['overall satisfaction', 'Boston bowel preparation scale (BBPS', 'BBPS score', 'insertion time, withdrawal time, polyp detection rate, patient tolerance, and willingness to use the same diet for bowel preparation again', 'Patient tolerance', 'colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores', 'bowel preparation quality', 'tolerance and satisfaction levels', 'quality of bowel preparation', 'Bowel preparation quality']",[],"[{'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0180022', 'cui_str': 'Colonoscope'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.099055,"The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.SJG_471_19'] 425,32221052,Evaluation of Vascular Endothelial Growth Factor (VEGF) and Thrombospondin-1 as Biomarkers of Metronomic Chemotherapy in Progressive Pediatric Solid Malignancies.,"OBJECTIVE We compared Vascular Endothelial Growth factor (VEGF) and Thrombospondin-1 between patients with progressive paediatric malignancies randomized to metronomic chemotherapy versus placebo to determine their role as biomarker. METHODS In this double-blinded, placebo-controlled randomized study of 108 progressive pediatric malignancies, serum VEGF and thrombospondin-1 levels were evaluated using ELISA at baseline, A2 (week-9 or earlier if progressed) and A3 (week-18 or earlier if progressed). RESULTS Mean VEGF and thrombospondin-1 at baseline, A2 and A3 and the change from baseline to A2 were not different between two groups. In metronomic arm, responders (those completing 3 cycles) had significantly lower mean (SD) baseline VEGF levels [659.7(362.1) vs 1143.9 (622.0) µg/mL] (P=0.002) and significant decrease in thrombospondin-1 from baseline to A2 [-4.43(8.0) µg/mL vs 1.7(11.3) µg/mL] (P=0.04), as compared to non-responders. Similar changes were not observed in responders on placebo arm. No consistent trend of these biomarkers was observed. CONCLUSIONS VEGF and thrombospondin-1 are not reliable biomarkers for response to metronomic chemotherapy.",2020,"In metronomic arm, responders (those completing 3 cycles) had significantly lower mean (SD) baseline VEGF levels [659.7(362.1) vs 1143.9 (622.0) μg/mL] (P=0.002) and significant decrease in thrombospondin-1 from baseline to A2 [-4.43(8.0) μg","['Progressive Pediatric Solid Malignancies', '108 progressive pediatric malignancies, serum VEGF and Thrombospondin-1 levels were evaluated using ELISA at baseline, A2 (week-9 or earlier if progressed) and A3 (week-18 or earlier if progressed', 'patients with progressive paediatric malignancies']","['placebo', 'Vascular Endothelial Growth Factor (VEGF) and Thrombospondin-1', 'VEGF and Thrombospondin-1', 'metronomic chemotherapy versus placebo', 'Vascular Endothelial Growth factor (VEGF) and Thrombospondin-1']","['thrombospondin-1', 'mean (SD) baseline VEGF levels', 'Mean VEGF and Thrombospondin-1']","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0147139', 'cui_str': 'TSP-1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0147139', 'cui_str': 'TSP-1'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0147139', 'cui_str': 'TSP-1'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",108.0,0.348687,"In metronomic arm, responders (those completing 3 cycles) had significantly lower mean (SD) baseline VEGF levels [659.7(362.1) vs 1143.9 (622.0) μg/mL] (P=0.002) and significant decrease in thrombospondin-1 from baseline to A2 [-4.43(8.0) μg","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Pramanik', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anudishi', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Agarwala', 'Affiliation': 'Department of Paediatric Surgrery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dhawan', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Dr Sameer Bakhshi, Professor of Pediatric Oncology, Department of Medical Oncology, Dr BRA Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110 029, India. sambakh@hotmail.com.'}]",Indian pediatrics,[] 426,32215583,Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer.,"Importance In men with recurrent prostate cancer, addition of long-term antiandrogen therapy to salvage radiotherapy (SRT) was associated with overall survival (OS) in the NRG/RTOG 9601 study. However, hormone therapy has associated morbidity, and there are no validated predictive biomarkers to identify which patients derive most benefit from treatment. Objective To examine the role of pre-SRT prostate-specific antigen (PSA) levels to personalize hormone therapy use with SRT. Interventions Men were randomized to SRT plus high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d) or placebo for 2 years. Design, Setting, and Participants In this secondary analysis of the multicenter RTOG 9601 double-blind, placebo-controlled randomized clinical trial conducted from 1998 to 2003 by a multinational cooperative group, men with a positive surgical margin or pathologic T3 disease after radical prostatectomy with pre-SRT PSA of 0.2 to 4.0 ng/mL were included. Analysis was performed between March 4, 2019, and December 20, 2019. Main Outcomes and Measures The primary outcome was overall survival (OS). Secondary end points included distant metastasis (DM), other-cause mortality (OCM), and grades 3 to 5 cardiac and neurologic toxic effects. Subgroup analyses were performed using the protocol-specified PSA stratification variable (1.5 ng/mL) and additional PSA cut points, including test for interaction. Competing risk analyses were performed for DM and other-cause mortality (OCM). Results Overall, 760 men with PSA elevation after radical prostatectomy for prostate cancer were included. The median (range) age of particpants was 65 (40-83) years. Antiandrogen assignment was associated with an OS benefit in the PSA stratum greater than 1.5 ng/mL (n = 118) with a 25% 12-year absolute benefit (hazard ratio [HR], 0.45; 95% CI, 0.25-0.81), but not in the PSA of 1.5 ng/mL or less stratum (n = 642) (1% 12-year absolute difference; HR, 0.87; 95% CI, 0.66-1.16). In a subanalysis of men with PSA of 0.61 to 1.5 (n = 253), there was an OS benefit associated with antiandrogen assignment (HR, 0.61; 95% CI, 0.39-0.94). In those receiving early SRT (PSA ≤0.6 ng/mL, n = 389), there was no improvement in OS (HR, 1.16; 95% CI, 0.79-1.70), an increased OCM hazard (subdistribution HR, 1.94; 95% CI, 1.17-3.20; P = .01), and an increased odds of late grades 3 to 5 cardiac and neurologic toxic effects (odds ratio, 3.57; 95% CI, 1.09-15.97; P = .05). Conclusions and Relevance These results suggest that pre-SRT PSA level may be a prognostic biomarker for outcomes of antiandrogen treatment with SRT. In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes. In men receiving early SRT (PSA ≤0.6 ng/mL), long-term antiandrogen treatment was not associated with improved OS. Future randomized clinical trials are needed to determine hormonal therapy benefit in this population. Trial Registration ClinicalTrials.gov Identifier: NCT00002874.",2020,"In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes.","['Interventions\n\n\nMen', 'Men With Prostate Cancer', '760 men with PSA elevation after radical prostatectomy for prostate cancer', 'men with recurrent prostate cancer, addition of long-term', '1998 to 2003 by a multinational cooperative group, men with a positive surgical margin or pathologic T3 disease after radical prostatectomy with pre-SRT PSA of 0.2 to 4.0 ng/mL were included']","['SRT plus high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d) or placebo', 'Long-term Antiandrogen Therapy', 'antiandrogen therapy to salvage radiotherapy (SRT', 'placebo']","['OS benefit', 'Presalvage Radiotherapy PSA Levels', 'distant metastasis (DM), other-cause mortality (OCM), and grades 3 to 5 cardiac and neurologic toxic effects', 'overall survival (OS', 'OCM hazard', 'neurologic toxic effects', 'OS', 'improved OS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1320169', 'cui_str': 'AntiAndrogens, Nonsteroidal'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",760.0,0.618209,"In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Dess', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Jackson', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Jairath', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Amar U', 'Initials': 'AU', 'LastName': 'Kishan', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Wallington', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Mahal', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Stish', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Zachery S', 'Initials': 'ZS', 'LastName': 'Zumsteg', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, West Hollywood, California.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Den', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Laila A', 'Initials': 'LA', 'LastName': 'Gharzai', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaworski', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Zachary R', 'Initials': 'ZR', 'LastName': 'Reichert', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Morgan', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Department of Pathology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Department of Medicine, Tulane Cancer Center, New Orleans, Louisiana.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William Robert', 'Initials': 'WR', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Duke Health, Durham, North Carolina.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, Sutter Medical Group, Sacramento, California.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Schipper', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dignam', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Zietman', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, West Hollywood, California.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0109'] 427,32235852,Kinesiologist-guided functional exercise in addition to intradialytic cycling program in end-stage kidney disease patients: a randomised controlled trial.,"Intradialytic cycling is a widely used workout mode, whereas added benefit of other exercise modalities remains unknown. This is the first randomised controlled trial on the effects and sustainability of functional training and counselling in addition to intradialytic cycling. Patients were randomly assigned to a kinesiologist-guided functional training in addition to intradialytic cycling (n = 20, experimental group) or intradialytic cycling only (n = 20, control group) over 16 weeks. The experimental group attended predialysis functional exercise in the first eight weeks and afterward performed functional training at home for the next eight weeks. The primary study endpoint was 10-repetition-sit-to-stand test time at eight weeks: at this test, the experimental group improved significantly better than controls (-4.5 ± 1.9 s, 95%CI -8.4 to -0.7; P = 0.021), which was maintained at week 16 (-4.7 ± 2.1 s, 95%CI -9.0 to -0.3; P = 0.037). At week 8, the experimental group significantly outperformed controls also at handgrip strength (P = 0.004), lower body flexibility test (P < 0.001), balance test (P < 0.001), and upper body flexibility test (P = 0.003). At week 16, superior results of the experimental group in secondary end-points remained preserved for handgrip strength, balance, and upper body flexibility tests. Functional training with exercise counselling meaningfully improves physical performance and successfully prepares patients for sustainable home exercise.",2020,"At week 8, the experimental group significantly outperformed controls also at handgrip strength (P = 0.004), lower body flexibility test (P < 0.001), balance test (P < 0.001), and upper body flexibility test (P = 0.003).",['end-stage kidney disease patients'],"['predialysis functional exercise', 'functional training and counselling', 'kinesiologist-guided functional training in addition to intradialytic cycling (n\u2009=\u200920, experimental group) or intradialytic cycling', 'Kinesiologist-guided functional exercise', 'Functional training with exercise counselling', 'intradialytic cycling program']","['10-repetition-sit-to-stand test time', 'balance test', 'lower body flexibility test', 'handgrip strength', 'physical performance', 'handgrip strength, balance, and upper body flexibility tests', 'upper body flexibility test']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}]",,0.0834617,"At week 8, the experimental group significantly outperformed controls also at handgrip strength (P = 0.004), lower body flexibility test (P < 0.001), balance test (P < 0.001), and upper body flexibility test (P = 0.003).","[{'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Pajek', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jadranka', 'Initials': 'J', 'LastName': 'Buturović Ponikvar', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Vedran', 'Initials': 'V', 'LastName': 'Hadžić', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia. maja.pajek@fsp.uni-lj.si.'}]",Scientific reports,['10.1038/s41598-020-62709-1'] 428,31582360,"Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial.","BACKGROUND Infection with influenza virus causes substantial morbidity and mortality globally, although antiviral treatments are available. Previous studies have suggested that anti-influenza immune plasma could be beneficial as treatment, but they were not designed as randomised, blinded, placebo-controlled trials. Therefore, we aimed to prospectively evaluate the clinical efficacy of high-titre immune plasma compared with standard low-titre plasma to improve outcomes in patients with severe influenza A infection. METHODS We did this randomised, double-blind, phase 3 trial at 41 US medical centres to assess the efficacy of high-titre anti-influenza plasma (haemagglutination inhibition antibody titre ≥1:80) compared with low-titre plasma (≤1:10). Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible. Patients were randomly assigned (2:1) using an interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group), and were followed up for 28 days from randomisation. High-titre and low-titre plasma had the same appearance. Randomisation was stratified by severity (in intensive care unit, not in intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen) and age (<18 years and ≥18 years). All participants, site staff, and the study team were masked to treatment allocation until after the final database lock. The primary endpoint was clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities) analysed in a proportional odds model (an odds ratio [OR] >1 indicates improvement in clinical status across all categories for the high-titre vs the low-titre group). The primary analysis was done in the intention-to-treat population, excluding two participants who did not receive plasma. This trial is registered with ClinicalTrials.gov, NCT02572817. FINDINGS Participants were recruited between Jan 26, 2016, and April 19, 2018. Of 200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48). One participant from each group did not receive plasma. At baseline, 60 (43%) of 138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen. 93% of planned plasma infusions were completed. The study was terminated in July, 2018, when independent efficacy analysis showed low conditional power to detect an effect of high-titre plasma even if full accrual (150 participants) was achieved. The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54). 47 (34%) of 138 participants experienced 88 serious adverse events: 32 (35%) with 60 events in the high-titre group and 15 (32%) with 28 events in the low-titre group. The most common serious adverse events were acute respiratory distress syndrome (ARDS; four [4%] vs two [4%]), allergic transfusion reactions (two [2%] vs two [4%]), and respiratory distress (three [3%] vs none). 65 (47%) participants experienced 183 adverse events: 42 (46%) with 126 events in the high-titre group and 23 (49%) with 57 events in the low-titre group. The most common adverse events were anaemia (four [3%] vs two [4%]) and ARDS (four [3%] vs three [5%]). Ten patients died during the study (six [7%] in the high-titre group vs four [9%] in the low-titre group, p=0·73). The most common cause of death was worsening of acute respiratory distress syndrome (two [2%] vs two [4%] patients). INTERPRETATION High-titre anti-influenza plasma conferred no significant benefit over non-immune plasma. Although our study did not have the precision to rule out a small, clinically relevant effect, the benefit is insufficient to justify the use of immune plasma for treating patients with severe influenza A. FUNDING National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Bethesda, MD, USA).",2019,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","['patients with severe influenza A', '200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48', 'patients with severe influenza A infection', '138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen', 'Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible', 'Participants were recruited between Jan 26, 2016, and April 19, 2018']","['interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group', 'intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen', 'Anti-influenza immune plasma', 'standard low-titre plasma']","['anaemia', 'respiratory distress', 'ARDS', 'acute respiratory distress syndrome', 'clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities', 'allergic transfusion reactions', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1283787', 'cui_str': 'Allergic transfusion reaction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.445549,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. Electronic address: jbeigel@niaid.nih.gov.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Aga', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Marie-Carmelle', 'Initials': 'MC', 'LastName': 'Elie-Turenne', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Josalyn', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tebas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Clark', 'Affiliation': 'Beaumont Hospital-Royal Oak, Royal Oak, MI, USA.'}, {'ForeName': 'Jordan P', 'Initials': 'JP', 'LastName': 'Metcalf', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ozment', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kanakatte', 'Initials': 'K', 'LastName': 'Raviprakash', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Beeler', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Warner', 'Affiliation': 'Social & Scientific Systems, Silver Spring, MD, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Chorley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30199-7'] 429,31037789,Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.,"OBJECTIVE Adolescents and young adults (AYAs) with cancer are at high risk of negative psychosocial outcomes. Promoting Resilience in Stress Management (PRISM), a novel, brief, skill-based intervention, has demonstrated efficacy in improving psychosocial well-being for AYAs. We utilized data from a recent randomized trial of PRISM versus usual care (UC) to categorize and explore group differences in change trajectories of patient reported outcomes (PROs) over time. METHODS One hundred English-speaking AYAs (aged 12-25 years old) with cancer were randomized to PRISM versus UC. At enrollment and 6 months later, AYAs completed validated PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6). Patient response trajectories were categorized as ""improved,"" ""consistently well,"" ""consistently at risk,"" or ""deteriorated"" using minimal clinically important differences (MCIDs) or established measure cutoffs for all PROs. Positive response trajectories consisted of the first two categories (""improved"" and ""consistently well""), and negative response trajectories consisted of the latter two categories (""consistently at risk"" and ""deteriorated""). RESULTS Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time. Across all PROs, a greater proportion of PRISM participants (vs UC) experienced positive response trajectories. Across all PROs, a greater proportion of UC participants experienced negative response trajectories. CONCLUSIONS PRISM shows evidence of both a prevention effect and an intervention effect. Thus, PRISM may serve as a viable prevention and early intervention model for psychosocial care.",2019,"Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time.","['Adolescents and young adults (AYAs) with cancer', 'One hundred English-speaking AYAs (aged 12-25 years old) with cancer']","['PRISM versus UC', 'PRISM versus usual care (UC']","['PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",100.0,0.0429357,"Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lau', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Steineck', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Junkins', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': 'Division of Child Psychiatry, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}]",Psycho-oncology,['10.1002/pon.5098'] 430,31515154,"Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1-2 trial.","BACKGROUND Taxane-platinum combinations have shown promising activity in metastatic castration-resistant prostate cancers in single-group clinical studies but not in randomised trials. Distinct biological subsets of the disease might derive the greatest benefit from the addition of platinum. We aimed to determine whether adding carboplatin to cabazitaxel would improve the outcomes of men with metastatic castration-resistant prostate cancer. METHODS We did a phase 1-2, open label, randomised study at two centres in men with progressive metastatic castration-resistant prostate cancer. In phase 1, patients received intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin area under the curve (AUC) 3-4 mg/mL per min every 21 days. The maximum tolerated dose was defined as the highest dose cohort studied in which one of six or fewer patients experienced a dose-limiting toxicity. In phase 2, patients were randomly assigned (1:1) centrally by a computerised algorithm to intravenous cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min. All patients received growth factor support and oral prednisone 10 mg daily. The primary endpoints were the maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival in phase 2. This trial is registered at ClinicalTrials.gov, number NCT01505868. FINDINGS Between Aug 17, 2012, and May 11, 2015, nine patients completed phase 1 as planned, and 160 were randomly assigned to cabazitaxel (n=79) or cabazitaxel plus carboplatin (n=81) in phase 2. During phase I, grade 3 adverse events were anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events occurred. No dose-limiting toxicities were observed, therefore, a maximum tolerated dose of cabazitaxel of 25 mg/m 2 and carboplatin of AUC 4 mg/mL per min was selected for phase 2. At a median follow-up of 31·0 months (IQR 20·5-37·1), the combination improved the median progression-free survival from 4·5 months (95% CI 3·5-5·7) to 7·3 months (95% CI 5·5-8·2; hazard ratio 0·69, 95% CI 0·50-0·95, p=0·018). In the phase 2 study, the most common grade 3-5 adverse events were fatigue (7 [9%] of 79 in the cabazitaxel group vs 16 [20%] of 81 in the combination group), anaemia (3 [4%] vs 19 [23%]), neutropenia (3 [4%] vs 13 [16%]), and thrombocytopenia (1 [1%] vs 11 [14%]). There were no treatment-related deaths. INTERPRETATION Carboplatin added to cabazitaxel showed improved clinical efficacy compared with cabazitaxel alone for men with metastatic castration-resistant prostate cancer. Although adverse events were more common with the combination, the treatment was safe and generally well tolerated. Our data suggest that taxane-platinum combinations have a clinically beneficial role in advanced prostate cancer and a randomised phase 3 study is planned. FUNDING Sanofi Genzyme, University of Texas MD Anderson Cancer Center Prostate Cancer Moon Shot Program, and Solon Scott III Prostate Cancer Research Fund.",2019,"There were no treatment-related deaths. ","['men with metastatic castration-resistant prostate cancer', 'Between Aug 17, 2012, and May 11, 2015', 'men with progressive metastatic castration-resistant prostate cancer', 'men with metastatic castration-resistant prostate cancers']","['Taxane-platinum combinations', 'Carboplatin', 'Cabazitaxel plus carboplatin', 'cabazitaxel', 'cabazitaxel plus carboplatin', 'taxane-platinum combinations', 'intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin', 'carboplatin to cabazitaxel', 'cabazitaxel alone', 'cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min', 'growth factor support and oral prednisone']","['clinical efficacy', 'safe and generally well tolerated', 'thrombocytopenia', 'anaemia', 'anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events', 'neutropenia', 'median progression-free survival', 'maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival', 'maximum tolerated dose']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",,0.212863,"There were no treatment-related deaths. ","[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elisabeth I', 'Initials': 'EI', 'LastName': 'Heath', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Ramesh', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Sei', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Li-Ning-Tapia', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Tu', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Subudhi', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Thompson', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Troncoso', 'Affiliation': 'Department of Anatomical Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Navin', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Aparicio', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: aaparicio@mdanderson.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30408-5'] 431,31706317,Bronchial blocker versus double-lumen endobronchial tube in minimally invasive cardiac surgery.,"BACKGROUND To compare the therapeutic value of a bronchial blocker (BB) with a double-lumen tube (DLT) in minimally invasive cardiac surgery (MICS). METHODS Sixty patients who underwent MICS were randomized to use either a DLT (Group D, n = 30) or a BB (Group B, n = 29; one failed was omitted). The following data were collected: time of intubation and tube localization; incidence of tube displacement; postoperative sore throat and hoarseness; time of cardiopulmonary bypass; maintenance time for SpO 2  < 90% (PaCO 2  < 60 mmHg); mean arterial pressure and heart rate; SpO 2 , PaO 2 , PaCO 2 , EtCO 2 , mean airway pressure, and airway peak pressure; surgeons' satisfaction with anesthesia; and short-term complications. RESULTS The times of intubation and tube localization were significantly longer in Group B than in Group D (P < 0.05). Patients in Group B exhibited significantly lower incidence of tube displacement, postoperative sore throat, and hoarseness when compared with patients in Group D (P < 0.05). Mean arterial pressure and heart rate were significantly lower in Group B than in Group D after tracheal intubation (P < 0.05). The mean airway pressure and airway peak pressure were significantly lower in Group B than in Group D after one-lung ventilation (P < 0.05). SpO 2 and PaO 2 in Group B were significantly higher than in group D after cardiopulmonary bypass (P < 0.05). No short-term postoperative complications were observed in patients of Groups B and D during 3 month follow-up. CONCLUSION BB can be a potential alternative to the conventional DLT for lung isolation in MICS. TRIAL REGISTRATION ChiCTR1900024250, July 2, 2019.",2019,The mean airway pressure and airway peak pressure were significantly lower in Group B than in Group D after one-lung ventilation (P < 0.05).,"['Sixty patients who underwent MICS', 'minimally invasive cardiac surgery', 'SpO 2 \u2009<\u200990% (PaCO 2 \u2009<\u200960\u2009mmHg', 'minimally invasive cardiac surgery (MICS']","['DLT', 'Bronchial blocker versus double-lumen endobronchial tube', 'bronchial blocker (BB) with a double-lumen tube (DLT']","['incidence of tube displacement, postoperative sore throat, and hoarseness', 'mean airway pressure and airway peak pressure', 'time of intubation and tube localization; incidence of tube displacement; postoperative sore throat and hoarseness; time of cardiopulmonary bypass; maintenance time', ""mean arterial pressure and heart rate; SpO 2 , PaO 2 , PaCO 2 , EtCO 2 , mean airway pressure, and airway peak pressure; surgeons' satisfaction with anesthesia; and short-term complications"", 'Mean arterial pressure and heart rate', 'times of intubation and tube localization', 'No short-term postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1275736', 'cui_str': 'Endobronchial tube'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3267120', 'cui_str': 'Airway peak pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",60.0,0.0268116,The mean airway pressure and airway peak pressure were significantly lower in Group B than in Group D after one-lung ventilation (P < 0.05).,"[{'ForeName': 'Chuncheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, No.218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, No.218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin province, China.'}, {'ForeName': 'Mingyue', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, No.218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, No.218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Yanbian University, Yanbian, 130000, Jilin province, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, No.218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin province, China.'}, {'ForeName': 'Cailian', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, No.218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin province, China.'}, {'ForeName': 'Weixuan', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Intensive Care Unit, The Second Hospital of Jilin University, Changchun, 130041, Jilin province, China.'}, {'ForeName': 'Zhenxiang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, No.218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin province, China. Panzhxia999@163.com.'}]",BMC pulmonary medicine,['10.1186/s12890-019-0956-x'] 432,31150315,Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12.,"PURPOSE Total neoadjuvant therapy is a new paradigm for rectal cancer treatment. Optimal scheduling of preoperative chemoradiotherapy (CRT) and chemotherapy remains to be established. PATIENTS AND METHODS We conducted a multicenter, randomized, phase II trial using a pick-the-winner design on the basis of the hypothesis of an increased pathologic complete response (pCR) of 25% after total neoadjuvant therapy compared with standard 15% after preoperative CRT. Patients with stage II or III rectal cancer were assigned to group A for induction chemotherapy using three cycles of fluorouracil, leucovorin, and oxaliplatin before fluorouracil/oxaliplatin CRT (50.4 Gy) or to group B for consolidation chemotherapy after CRT. Secondary end points included toxicity, compliance, and surgical morbidity. RESULTS Of the 311 patients enrolled, 306 patients were evaluable (156 in group A and 150 in group B). CRT-related grade 3 or 4 toxicity was lower (37% v 27%) and compliance with CRT higher in group B (91%, 78%, and 76% v 97%, 87%, and 93% received full-dose radiotherapy, concomitant fluorouracil, and concomitant oxaliplatin in groups A and B, respectively); 92% versus 85% completed all induction/consolidation chemotherapy cycles, respectively. The longer interval between completion of CRT and surgery in group B (median 90 v 45 days in group A) did not increase surgical morbidity. A pCR in the intention-to-treat population was achieved in 17% in group A and in 25% in group B. Thus, only group B ( P  < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis. CONCLUSION Up-front CRT followed by chemotherapy resulted in better compliance with CRT but worse compliance with chemotherapy compared with group A. Long-term follow-up will assess whether improved pCR in group B translates to better oncologic outcome.",2019,"B. Thus, only group B ( P  < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis. ","['311 patients enrolled', 'Patients with stage II or III rectal cancer', 'Locally Advanced Rectal Cancer', '306 patients were evaluable']","['chemotherapy', 'induction chemotherapy', 'fluorouracil, leucovorin, and oxaliplatin before fluorouracil/oxaliplatin CRT', 'radiotherapy, concomitant fluorouracil, and concomitant oxaliplatin', 'Chemoradiotherapy Plus Induction or Consolidation Chemotherapy', 'preoperative chemoradiotherapy (CRT) and chemotherapy']","['CRT-related grade 3 or 4 toxicity', 'toxicity, compliance, and surgical morbidity', 'surgical morbidity', 'pathologic complete response (pCR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",311.0,0.0747186,"B. Thus, only group B ( P  < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis. ","[{'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Allgäuer', 'Affiliation': 'Barmherzige Brüder Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Polat', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Klautke', 'Affiliation': 'Poliklinik Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': 'DiaCura, Klinikum Coburg, Coburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuhnt', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brunner', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Wolff', 'Initials': 'W', 'LastName': 'Schmiegel', 'Affiliation': 'Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Jacobasch', 'Affiliation': 'Praxis of Haematology and Oncology, Dresden, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Schlenska-Lange', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Flentje', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christoph-Thomas', 'Initials': 'CT', 'LastName': 'Germer', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwarzbach', 'Affiliation': 'Klinikum Frankfurt Höchst, Frankfurt, Germany.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Paolucci', 'Affiliation': 'Ketteler Krankenhaus, Offenbach, Germany.'}, {'ForeName': 'Wolf O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00308'] 433,30816331,"Treatment of higher risk acute lymphoblastic leukemia in young people (CCG-1961), long-term follow-up: a report from the Children's Oncology Group.","Children's Cancer Group CCG-1882 improved outcome for 1-21-year old with high risk acute lymphoblastic leukemia and Induction Day 8 marrow blasts ≥25% (slow early responders, SER) with longer and stronger post induction intensification (PII). This CCG-1961 explored alternative PII strategies. We report 10-year follow-up for patients with rapid early response (RER) and for the first time details our experience for SER patients. A total of 2057 patients were enrolled, and 1299 RER patients were randomized to 1 of 4 PII regimens: standard vs. augmented intensity and standard vs. increased length. At the end of interim maintenance, 447 SER patients were randomized to idarubicin/cyclophosphamide or weekly doxorubicin in the delayed intensification phases. The 10-year EFS for RER were 79.4 ± 2.4% and 70.9 ± 2.6% (hazard ratio = 0.65, 95% CI 0.52-0.82, p < 0.001) for augmented and standard strength PII; the 10-year OS rates were 87.2 ± 2.0% and 81.0 ± 2.2% (hazard ratio = 0.64, 95% CI 0.48-0.86, p = 0.003). Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin. The EFS and OS advantage of augmented PII is sustained at 10 years for RER patients. Longer PII for RER patients and sequential idarubicin/cyclophosphamide for SER patients offered no advantage. CCG-1961 is the platform for subsequent COG studies.",2019,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","['patients with rapid early response (RER) and for the first time\xa0details our experience for SER patients', '447 SER patients', '2057 patients were enrolled, and 1299 RER patients']","['idarubicin/cyclophosphamide and weekly doxorubicin', 'idarubicin/cyclophosphamide or weekly doxorubicin', 'idarubicin/cyclophosphamide', 'CCG-1961']","['10-year OS rates', '10-year EFS for RER']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2057.0,0.0559644,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Steinherz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. steinhep@mskcc.org.'}, {'ForeName': 'Nita L', 'Initials': 'NL', 'LastName': 'Seibel', 'Affiliation': ""Children's National Health System, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.""}, {'ForeName': 'Harland', 'Initials': 'H', 'LastName': 'Sather', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Gaynon', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}]",Leukemia,['10.1038/s41375-019-0422-z'] 434,32252100,Influence of Respiratory Muscle Training on Patients' Recovery after Lung Resection.,"This prospective experimental study aimed to compare effects of 3 different home-based postoperative respiratory muscle training protocols - inspiratory, expiratory and combined, in the patients' postoperative recovery, regarding safety and respiratory muscle function, pulmonary function, physical fitness, physical activity (PA), dyspnoea and quality of life (QoL). Patients were divided in four groups Usual Care (UCare), inspiratory (IMT), expiratory (EMT) or combined muscle training (CombT) according to group allocation. Significant treatment*time interactions were found for maximal inspiratory pressure (MIP) (p=0.014), sedentary PA (SEDPA) (p=0.003), light PA (LIGPA) (p=0.045) and total PA (p=0.035). Improvements were observed for MIP in CombT (p=0.001), IMT (p=0.001), EMT (p=0.050). SEDPA reduced in EMT (p=0.001) and IMT (p=0.006), while LIGPA increased in both groups (p=0.001), as well as Total PA (p=0.005 and p=0.001, respectively). In UCare, CombT, and EMT, QoL improved only for Usual Activities. In conclusion, the addition of respiratory muscle training to physiotherapy usual care is safe and effective to increase MIP and contribute to improve physical activity. The CombT showed greater improvement on MIP, while IMT compared to EMT, was more effective to improve physical activity.",2020,"Significant treatment*time interactions were found for maximal inspiratory pressure (MIP) (p=0.014), sedentary PA (SEDPA) (p=0.003), light PA (LIGPA) (p=0.045) and total PA (p=0.035).","[""Patients' Recovery after Lung Resection""]","['EMT', '3 different home-based postoperative respiratory muscle training protocols - inspiratory, expiratory and combined', 'Usual Care (UCare), inspiratory (IMT), expiratory (EMT) or combined muscle training (CombT) according to group allocation', 'Respiratory Muscle Training']","['MIP in CombT', 'physical activity', 'light PA (LIGPA', 'LIGPA', 'MIP', 'safety and respiratory muscle function, pulmonary function, physical fitness, physical activity (PA), dyspnoea and quality of life (QoL', 'total PA', 'sedentary PA (SEDPA', 'SEDPA reduced in EMT', 'maximal inspiratory pressure (MIP', 'Total PA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}]",,0.0146692,"Significant treatment*time interactions were found for maximal inspiratory pressure (MIP) (p=0.014), sedentary PA (SEDPA) (p=0.003), light PA (LIGPA) (p=0.045) and total PA (p=0.035).","[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Kendall', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Silva', 'Affiliation': 'Research Center in Sports Sciences, Health and Human Development (CIDESD), University Institute of Maia (ISMAI), Maia, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Almeida', 'Affiliation': 'Sleep Medicine Department, Hospital CUF, Porto, Portugal.'}, {'ForeName': 'Ermelinda', 'Initials': 'E', 'LastName': 'Eusébio', 'Affiliation': 'Pulmonology Department, Centro Hospitalar São João, Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Pinho', 'Affiliation': 'Department of Cardiothoracic Surgery, Centro Hospitalar São João, Porto, Portugal.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Pedro Teixeira', 'Initials': 'PT', 'LastName': 'Bastos', 'Affiliation': 'Department of Cardiothoracic Surgery, Centro Hospitalar São João, Porto, Portugal.'}]",International journal of sports medicine,['10.1055/a-1096-0913'] 435,30911113,"Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia.","Telomere length in chronic lymphocytic leukemia (CLL) has been shown to be of prognostic importance, but the analyses have largely been executed on heterogeneous patient cohorts outside of clinical trials. In the present study, we performed a comprehensive analysis of telomere length associations in the well characterized CLL8 trial (n = 620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n = 293). Absolute telomere length was analyzed using quantitative-PCR. Apart from identifying associations of short telomere length with adverse prognostic factors and survival, the study identified cases with 17p- and 11q- associated with TP53 and ATM loss, respectively, to have the shortest telomeres, even when these aberrations were present in small subclones. Thus, telomere shortening may precede acquisition of the high-risk aberrations, contributing to disease evolution. In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.",2019,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","['well characterized CLL8 trial (n\u2009=\u2009620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n\u2009=\u2009293', 'chronic lymphocytic leukemia (CLL', 'chronic lymphocytic leukemia']",[],"['TP53 and ATM loss', 'Absolute telomere length', 'genomic complexity']","[{'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0678214', 'cui_str': 'atmosphere (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}]",,0.0234911,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","[{'ForeName': 'Billy Michael Chelliah', 'Initials': 'BMC', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Landau', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Amaro N', 'Initials': 'AN', 'LastName': 'Taylor-Weiner', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bloehdorn', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Scheffold', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jäger', 'Affiliation': 'Department of Medicine I, Division of Hematology and Hemostaeology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Zenz', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Wenger', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wendtner', 'Affiliation': 'Klinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany. stephan.stilgenbauer@uniklinik-ulm.de.'}]",Leukemia,['10.1038/s41375-019-0446-4'] 436,32253520,Home-based inspiratory muscle training in pediatric patients after kidney transplantation: a randomized clinical trial.,"BACKGROUND Chronic kidney disease (CKD) represents the irreversible stages of renal failure and is a growing worldwide public health issue associated with increases in morbidity, mortality, and decreased quality of life. Kidney transplantation is considered one of the best treatment options in this population. However, even after surgery, respiratory muscle strength is below normal values, and inspiratory muscle training (IMT) improves respiratory muscle function, strength, and endurance. This study aimed to evaluate the effects of IMT regarding respiratory muscle strength, functional capacity, and pulmonary function in pediatric kidney transplant recipients with CKD, and secondarily, to assess the biochemical profile of patients after intervention. METHODS This is a randomized, double-blind, placebo-controlled trial. Patients were randomized into two groups, intervention (IG) and control (CG) and performed IMT home-based training for 6 weeks. In the IG, the load was adjusted to 40% of the maximal inspiratory pressure and in the CG was adjusted to a minimum placebo load (9 cm H 2 O). RESULTS Thirty-one patients were randomly allocated to the intervention (n = 16) or control (n = 15) groups. There were no differences at baseline between groups. Increase of 35% in the maximal inspiratory pressure predicted and 26% in the maximal expiratory pressure predicted in the IG were found, compared with 5 and 4% in the CG. There was an increase in hemoglobin and hematocrit values in the IG. CONCLUSIONS Home-based IMT provides a significant increase in respiratory muscle strength, without changes in functional capacity and pulmonary function. Benefits regarding biochemical markers (hemoglobin and hematocrit) were also observed.",2020,"There was an increase in hemoglobin and hematocrit values in the IG. ","['Thirty-one patients', 'Chronic kidney disease (CKD', 'pediatric kidney transplant recipients with CKD', 'pediatric patients after kidney transplantation']","['IMT', 'intervention (IG) and control (CG) and performed IMT home-based training for 6\xa0weeks', 'placebo', 'Home-based inspiratory muscle training']","['maximal expiratory pressure', 'respiratory muscle function, strength, and endurance', 'biochemical markers (hemoglobin and hematocrit', 'respiratory muscle strength', 'maximal inspiratory pressure', 'hemoglobin and hematocrit values', 'functional capacity and pulmonary function']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",31.0,0.0551409,"There was an increase in hemoglobin and hematocrit values in the IG. ","[{'ForeName': 'Raquel P', 'Initials': 'RP', 'LastName': 'Carbonera', 'Affiliation': 'Graduate Program in Pediatrics, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Ana Paula O', 'Initials': 'APO', 'LastName': 'Barbosa', 'Affiliation': 'Academics in Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Tatiana C', 'Initials': 'TC', 'LastName': 'Normann', 'Affiliation': 'Academics in Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Pedro Dal', 'Initials': 'PD', 'LastName': 'Lago', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Clotilde D', 'Initials': 'CD', 'LastName': 'Garcia', 'Affiliation': 'Graduate Program in Pediatrics, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Janice Luisa', 'Initials': 'JL', 'LastName': 'Lukrafka', 'Affiliation': 'Graduate Program in Pediatrics, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. janicet@ufcspa.edu.br.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04539-x'] 437,32252976,Onset and maintenance of efficacy of subcutaneous tanezumab in patients with moderate to severe osteoarthritis of the knee or hip: A 16-week dose-titration study.,"OBJECTIVE To examine the onset and maintenance of efficacy of subcutaneous tanezumab for pain relief and functional improvement in difficult-to-treat patients with moderate-to-severe osteoarthritis (OA) in a 16-week dose-titration study (NCT02697773). METHODS Patients were randomized to placebo (placebo group) or tanezumab 2.5 mg at baseline and week 8 (tanezumab 2.5 mg group), or tanezumab 2.5 mg at baseline and tanezumab 5 mg at week 8 (tanezumab 2.5/5 mg group). Analyses included change from baseline in average daily index joint pain and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and treatment responses (WOMAC Pain improvement criteria and Outcome Measures in Rheumatology-Osteoarthritis Research Society International [OMERACT-OARSI] criteria). RESULTS The 696 patients received placebo (n = 232), tanezumab 2.5 mg (n = 231), or tanezumab 2.5/5 mg (n = 233). Average daily index joint pain was statistically significantly improved within the first week (day 3-5) with tanezumab 2.5 mg compared with placebo. On first post-randomization WOMAC measurement (week 2), both tanezumab groups had statistically significant improvements compared with placebo in WOMAC Pain and Physical Function, and more tanezumab-treated patients achieved treatment response criteria (≥30%, ≥50%, or ≥70% reduction in WOMAC Pain or OMERACT-OARSI response). Efficacy was generally maintained throughout the 16-week treatment period. CONCLUSION Subcutaneous tanezumab provided statistically significant improvements compared with placebo in average daily index joint pain within the first week and WOMAC Pain and Physical Function (week 2) that were generally maintained throughout the 16-week treatment period. Tanezumab 5 mg provided only modest additional efficacy over tanezumab 2.5 mg.",2020,Average daily index joint pain was statistically significantly improved within the first week (day 3-5) with tanezumab 2.5 mg compared with placebo.,"['patients with moderate-to-severe osteoarthritis (OA', 'Patients', '696 patients received', 'patients with moderate to severe osteoarthritis of the knee or hip']","['placebo', 'tanezumab', 'tanezumab 2.5\xa0mg (n\xa0=\xa0231), or tanezumab', 'tanezumab 2.5\xa0mg at baseline and week 8 (tanezumab 2.5\xa0mg group), or tanezumab 2.5\xa0mg at baseline and tanezumab 5\xa0mg at week 8 (tanezumab', 'Tanezumab', 'subcutaneous tanezumab', 'placebo (placebo']","['WOMAC Pain or OMERACT-OARSI response', 'WOMAC Pain and Physical Function', 'WOMAC) Pain and Physical Function, and treatment responses (WOMAC Pain improvement criteria', 'average daily index joint pain', 'average daily index joint pain and Western Ontario and McMaster Universities Osteoarthritis Index', 'pain relief and functional improvement', 'Efficacy', 'Average daily index joint pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0298839,Average daily index joint pain was statistically significantly improved within the first week (day 3-5) with tanezumab 2.5 mg compared with placebo.,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schnitzer', 'Affiliation': 'Northwestern University Feinberg School of Medicine, 710 N Lake Shore Drive, Room 1020, Chicago, IL 60611, United States. Electronic address: tjs@northwestern.edu.'}, {'ForeName': 'Arifulla', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Northwest Clinical Research Center, Bellevue, WA, United States.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Laval University, Quebec City, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Davignon', 'Affiliation': 'Pfizer Inc., Groton, CT, United States.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc., Groton, CT, United States.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Pixton', 'Affiliation': 'Pfizer Inc., Morrisville, NC, United States.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Prucka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Tive', 'Affiliation': 'Pfizer Inc., New York, NY, United States.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc., Groton, CT, United States.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.03.004'] 438,32184135,Development of osteoarthritis in patients with degenerative meniscal tears treated with exercise therapy or surgery: a randomized controlled trial.,"OBJECTIVE To evaluate progression of individual radiographic features 5 years following exercise therapy or arthroscopic partial meniscectomy as treatment for degenerative meniscal tear. DESIGN Randomized controlled trial including 140 adults, aged 35-60 years, with a magnetic resonance image verified degenerative meniscal tear, and 96% without definite radiographic knee osteoarthritis. Participants were randomized to either 12-weeks of supervised exercise therapy or arthroscopic partial meniscectomy. The primary outcome was between-group difference in progression of tibiofemoral joint space narrowing and marginal osteophytes at 5 years, assessed semi-quantitatively by the OARSI atlas. Secondary outcomes included incidence of radiographic knee osteoarthritis and symptomatic knee osteoarthritis, medial tibiofemoral fixed joint space width (quantitatively assessed), and patient-reported outcome measures. Statistical analyses were performed using a full analysis set. Per protocol and as treated analysis were also performed. RESULTS The risk ratios (95% CI) for progression of semi-quantitatively assessed joint space narrowing and medial and lateral osteophytes for the surgery group were 0.89 (0.55-1.44), 1.15 (0.79-1.68) and 0.77 (0.42-1.42), respectively, compared to the exercise therapy group. In secondary outcomes (full-set analysis) no statistically significant between-group differences were found. CONCLUSION The study was inconclusive with respect to potential differences in progression of individual radiographic features after surgical and non-surgical treatment for degenerative meniscal tear. Further, we found no strong evidence in support of differences in development of incident radiographic knee osteoarthritis or patient-reported outcomes between exercise therapy and arthroscopic partial meniscectomy. TRIAL REGISTRATION www.clinicaltrials.gov (NCT01002794).",2020,"The primary outcome was between-group difference in progression of tibiofemoral joint space narrowing and marginal osteophytes at five years, assessed semi-quantitatively by the OARSI atlas.","['patients with degenerative meniscal tears treated with', 'degenerative meniscal tear', '140 adults, aged 35-60 years, with a magnetic resonance image verified degenerative meniscal tear, and 96% without definite radiographic knee osteoarthritis']","['exercise therapy or surgery', 'exercise therapy or arthroscopic partial meniscectomy', 'supervised exercise therapy or arthroscopic partial meniscectomy']","['incidence of radiographic knee osteoarthritis and symptomatic knee osteoarthritis, medial tibiofemoral fixed joint space width (quantitatively assessed), and patient-reported outcome measures', 'progression of tibiofemoral joint space narrowing and marginal osteophytes at five years, assessed semi-quantitatively by the OARSI atlas', 'progression of semi-quantitatively assessed joint space narrowing and medial and lateral osteophytes', 'risk ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0224497', 'cui_str': 'Articular space (body structure)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1859695'}, {'cui': 'C3698318', 'cui_str': 'Marginal osteophyte'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004171', 'cui_str': 'Atlases'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1956089', 'cui_str': 'Bone Spur'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",140.0,0.12339,"The primary outcome was between-group difference in progression of tibiofemoral joint space narrowing and marginal osteophytes at five years, assessed semi-quantitatively by the OARSI atlas.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Berg', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, Department of Interdisciplinary Health Sciences, University of Oslo, Oslo, Norway. Electronic address: bjornar.berg@studmed.uio.no.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. Electronic address: eroos@health.sdu.dk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Englund', 'Affiliation': 'Faculty of Medicine, Department of Clinical Sciences, Lund, Orthopedics, Clinical Epidemiology Unit, Lund University, Lund, Sweden. Electronic address: martin.englund@med.lu.se.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Kise', 'Affiliation': 'Department of Orthopedic Surgery, Martina Hansens Hospital, Sandvika, Norway. Electronic address: ninakise@hotmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tiulpin', 'Affiliation': 'Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland; Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland. Electronic address: aleksei.tiulpin@oulu.fi.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Saarakkala', 'Affiliation': 'Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland; Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland. Electronic address: simo.saarakkala@oulu.fi.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Engebretsen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Oslo Sports Trauma Research Center, Norwegian School of Sport Sciences, Oslo, Norway; Medical and Scientific Department, International Olympic Committee, Lausanne, Switzerland. Electronic address: lars.engebretsen@medisin.uio.no.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Eftang', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway. Electronic address: cathri.ne@icloud.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Holm', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, Department of Interdisciplinary Health Sciences, University of Oslo, Oslo, Norway. Electronic address: inger.holm@medisin.uio.no.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Risberg', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway; Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway. Electronic address: m.a.risberg@nih.no.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.01.020'] 439,32251641,"Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial.","BACKGROUND A monovalent, parenteral, subunit rotavirus vaccine was well tolerated and immunogenic in adults in the USA and in toddlers and infants in South Africa, but elicited poor responses against heterotypic rotavirus strains. We aimed to evaluate safety and immunogenicity of a trivalent vaccine formulation (P2-VP8-P[4],[6],[8]). METHODS A double-blind, randomised, placebo-controlled, dose-escalation, phase 1/2 study was done at three South African research sites. Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment. In the dose-escalation phase, adults and toddlers were randomly assigned in blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo. In the expanded phase, infants were randomly assigned in a 1:1:1:1 ratio to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo, in block sizes of four. Participants, parents of participants, and clinical, data, and laboratory staff were masked to treatment assignment. Adults received an intramuscular injection of vaccine or placebo in the deltoid muscle on the day of randomisation (day 0), day 28, and day 56; toddlers received a single injection of vaccine or placebo in the anterolateral thigh on day 0. Infants in both phases received an injection of vaccine or placebo in the anterolateral thigh on days 0, 28, and 56, at approximately 6, 10, and 14 weeks of age. Primary safety endpoints were local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events within 28 days after each injection in all participants who received at least one injection. Primary immunogenicity endpoints were analysed in infants in either phase who received all planned injections, had blood samples analysed at the relevant timepoints, and presented no major protocol violations considered to have an effect on the immunogenicity results of the study, and included serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses measured 4 weeks after the final injection in vaccine compared with placebo groups. This trial is registered with ClinicalTrials.gov, NCT02646891. FINDINGS Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group, 140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group) were randomly assigned, received at least one dose, and were assessed for safety. There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups. There were no serious adverse events within 28 days of injection in adults, whereas one serious adverse event occurred in a toddler (febrile convulsion in the 30 μg group) and 23 serious adverse events (four in placebo, ten in 15 μg, four in 30 μg, and five in 90 μg groups) occurred among 20 infants, most commonly respiratory tract infections. One death occurred in an infant within 28 days of injection due to pneumococcal meningitis. In 528 infants (130 in placebo, 132 in 15 μg, 132 in 30 μg, and 134 in 90 μg groups), adjusted anti-P2-VP8 IgG seroresponses (≥4-fold increase from baseline) to P[4], P[6], and P[8] antigens were significantly higher in the 15 μg, 30 μg, and 90 μg groups (99-100%) than in the placebo group (10-29%; p<0·0001). Although significantly higher than in placebo recipients (9-10%), anti-P2-VP8 IgA seroresponses (≥4-fold increase from baseline) to each individual antigen were modest (20-34%) across the 15 μg, 30 μg, and 90 μg groups. Adjusted neutralising antibody seroresponses in infants (≥2·7-fold increase from baseline) to DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]) were higher in vaccine recipients than in placebo recipients: p<0·0001 for all comparisons. INTERPRETATION The trivalent P2-VP8 vaccine was well tolerated, with promising anti-P2-VP8 IgG and neutralising antibody responses across the three vaccine P types. Our findings support advancing the vaccine to efficacy testing. FUNDING Bill & Melinda Gates Foundation.",2020,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","['528 infants (130 in', '140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group', ""Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment"", 'adults in the USA and in toddlers and infants in South Africa', 'Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group', 'three South African research sites', 'adults and toddlers']","['vaccine or placebo', 'parenteral trivalent P2-VP8 subunit rotavirus vaccine', 'placebo', 'intramuscular injection of vaccine or placebo', 'vaccine, or placebo', 'blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo', 'trivalent vaccine formulation (P2-VP8-P[4],[6],[8']","['serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses', 'serious adverse events', 'One death', 'local or systemic adverse events, or unsolicited adverse events', 'safety and immunogenicity', 'Safety and immunogenicity', '23 serious adverse events', 'Adjusted neutralising antibody seroresponses', 'local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events', 'adjusted anti-P2-VP8 IgG seroresponses', 'anti-P2-VP8 IgA seroresponses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",4.0,0.743237,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Groome', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: groomem@rmpru.co.za.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Family Clinical Research Unit, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Maysseb', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'PATH, Washington, DC, USA; Novavax, Gaithersburg, MD, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Power', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cryz', 'Affiliation': 'PATH, Washington, DC, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30001-3'] 440,31070709,"A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer.","BACKGROUND ASP8273, a novel, small molecule, irreversible tyrosine kinase inhibitor (TKI) specifically inhibits the epidermal growth factor receptor (EGFR) in patients with activating mutations or EGFR T790M resistance mutations. The current study examines the efficacy, safety, and tolerability of ASP8273 versus erlotinib or gefitinib in patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations not previously treated with an EGFR inhibitor. PATIENTS AND METHODS This global, phase III, open-label, randomized study evaluated ASP8273 versus erlotinib/gefitinib in patients with locally advanced, metastatic, or unresectable stage IIIB/IV NSCLC with activating EGFR mutations. They were ineligible if they received prior chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS), and secondary end points included overall survival, investigator-assessed PFS, best overall response rate (ORR), disease control rate, duration of response (DoR), and the safety/tolerability profile. RESULTS Patients (n = 530) were randomized 1 : 1 to receive ASP8273 (n = 267) or erlotinib/gefitinib (n = 263). Patient demographics between both treatment groups were generally balanced. Median PFS was 9.3 months (95% CI 5.6-11.1 months) for patients receiving ASP8273 and 9.6 months (95% CI 8.8-NE) for the erlotinib/gefitinib group, with a hazard ratio of 1.611 (P = 0.992). The ORR in the ASP8273 group was 33% (95% CI 27.4-39.0) versus 47.9% (95% CI 41.7-54.1) in the erlotinib/gefitinib group. Median DoR was similar for both groups (9.2 months for ASP8273 versus 9.0 months for erlotinib/gefitinib). More grade ≥3 treatment-emergent adverse events (TEAEs) occurred in patients receiving ASP8273 than in those receiving erlotinib/gefitinib (54.7% versus 43.5%). An independent data monitoring committee carried out an interim safety analysis and recommended discontinuing the study due to toxicity and limited predicted efficacy of ASP8273 relative to erlotinib/gefitinib. CONCLUSIONS First-line ASP8273 did not show improved PFS or equivalent toxicities versus erlotinib/gefitinib. CLINICALTRIAL.GOV NUMBER NCT02588261.",2019,"Median PFS was 9.3 months (95% CI, 5.6-11.1 months) for patients receiving ASP8273 and 9.6 months (95% CI, 8.8-NE) for the erlotinib/gefitinib group, with a hazard ratio of 1.611 (P=0.992).","['Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer', 'patients with activating mutations or EGFR T790M resistance mutations', 'patients with non-small cell lung cancer (NSCLC) with activating EGFR mutations not previously treated with an EGFR inhibitor', 'Patients (n=530', 'patients with locally advanced, metastatic, or unresectable stage IIIB/IV NSCLC with activating EGFR mutations']","['erlotinib/gefitinib', 'ASP8273 versus erlotinib or gefitinib', 'ASP8273', 'ASP8273 versus erlotinib/gefitinib', 'Erlotinib or Gefitinib']","['progression-free survival (PFS', 'efficacy, safety, and tolerability', 'overall survival, investigator-assessed PFS, best overall response rate (ORR), disease control rate, duration of response (DoR), and the safety/tolerability profile', 'PFS or equivalent toxicities', 'ORR', 'Median DoR', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",530.0,0.0680652,"Median PFS was 9.3 months (95% CI, 5.6-11.1 months) for patients receiving ASP8273 and 9.6 months (95% CI, 8.8-NE) for the erlotinib/gefitinib group, with a hazard ratio of 1.611 (P=0.992).","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Kelly', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore and The Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas, USA. Electronic address: Ronan.Kelly@BSWHealth.org.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krivoshik', 'Affiliation': 'Departments of Oncology.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Jie', 'Affiliation': 'Biostatistics, Astellas Pharma US, Inc., Northbrook.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz128'] 441,32149863,Learning mechanisms in nocebo hyperalgesia: the role of conditioning and extinction processes.,"Nocebo hyperalgesia is a clinically relevant phenomenon and may be formed as a result of associative learning, implemented by classical conditioning. This study explored for the first time distinct nocebo conditioning methods and their consequences for nocebo attenuation methods. Healthy participants (N = 140) were recruited and randomized to the following nocebo hyperalgesia induction groups: conditioning with continuous reinforcement (CRF), conditioning with partial reinforcement (PRF), and a sham-conditioning control group. In the attenuation phase, counterconditioning was compared with extinction. During induction, participants experienced increased thermal pain in 100% of nocebo trials in the CRF groups, while in only 70% of nocebo trials in the PRF groups. During evocation, pain stimulation was equivalent across all trials. During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups. Results showed that both PRF and CRF significantly induced nocebo hyperalgesia, but CRF was a more potent nocebo induction method, as compared to PRF. Counterconditioning was more effective than extinction in attenuating nocebo hyperalgesia. Neither CRF nor PRF resulted in resistance to extinction. However, compared with CRF, conditioning with PRF resulted in more resistance to counterconditioning. These findings demonstrate that the more ambiguous learning method of PRF can induce nocebo hyperalgesia and may potentially explain the treatment resistance and chronification seen in clinical practice. Further research is required to establish whether attenuation with counterconditioning is generalizable to clinical settings.",2020,"During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups.","['Healthy participants (N = 140', 'nocebo hyperalgesia']","['nocebo hyperalgesia induction groups: conditioning with continuous reinforcement (CRF), conditioning with partial reinforcement (PRF), and a sham-conditioning control group', 'PRF and CRF']","['nocebo hyperalgesia', 'pain stimulation', 'thermal pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",140.0,0.0465884,"During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups.","[{'ForeName': 'Mia Athina', 'Initials': 'MA', 'LastName': 'Thomaidou', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Dieuwke Swaantje', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Kaya Joanne', 'Initials': 'KJ', 'LastName': 'Peerdeman', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Naomi Zoë Sifra', 'Initials': 'NZS', 'LastName': 'Wiebing', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Joseph Sullivan', 'Initials': 'JS', 'LastName': 'Blythe', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Andrea Walbruga Maria', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}]",Pain,['10.1097/j.pain.0000000000001861'] 442,30682650,Impact of structured teaching program on the parent's knowledge of domiciliary management of seizure-A randomized controlled trial.,The aim of study was to assess the combined effectiveness of structured teaching program (STP) and patient information pamphlet (PIS) on caregivers' knowledge with regard to domiciliary management of seizure as compared with PIS alone. Study participants included caregivers of typically developing children aged 1-18 years with at least one episode of convulsion. The enrolled participants were allocated to either of the two groups: intervention group (STP along with PIS) and control group (PIS). The outcome was measured by a structured questionnaire - 'first-aid measures knowledge questionnaire'. Baseline knowledge scores were recorded and compared with postintervention scores measured at one-month follow-up. The preintervention knowledge scores were comparable in the two groups (p = 0.72). The control group has shown no significant difference in the knowledge scores at one-month follow-up (p = 0.58). Postintervention knowledge scores (p < 0.01) and mean difference in the knowledge scores (p < 0.01) were significantly higher in the intervention group when compared with controls. Structured teaching program regarding first-aid measures for convulsion along with PIS was effective in improving the knowledge of caregivers than PIS alone.,2019,Postintervention knowledge scores (p < 0.01) and mean difference in the knowledge scores (p < 0.01) were significantly higher in the intervention group when compared with controls.,['Study participants included caregivers of typically developing children aged 1-18\u202fyears with at least one episode of convulsion'],"['intervention group (STP along with PIS) and control group (PIS', 'structured teaching program (STP) and patient information pamphlet (PIS', 'structured teaching program', 'PIS alone']","[""structured questionnaire - 'first-aid measures knowledge questionnaire"", 'Baseline knowledge scores', 'knowledge scores', 'preintervention knowledge scores', 'Postintervention knowledge scores']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1869075', 'cui_str': 'Convulsions (SMQ)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016143', 'cui_str': 'First Aid'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0362011,Postintervention knowledge scores (p < 0.01) and mean difference in the knowledge scores (p < 0.01) were significantly higher in the intervention group when compared with controls.,"[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'College of Nursing, All India Institute of Medical Sciences, Delhi 110029, India. Electronic address: rksahu3112@gmail.com.'}, {'ForeName': 'Deepika C', 'Initials': 'DC', 'LastName': 'Khakha', 'Affiliation': 'College of Nursing, All India Institute of Medical Sciences, Delhi 110029, India.'}, {'ForeName': 'Sheffali', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Delhi 110029, India.'}, {'ForeName': 'Jaya Shankar', 'Initials': 'JS', 'LastName': 'Kaushik', 'Affiliation': 'Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Delhi 110029, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2018.11.038'] 443,32255212,Influence of a customized three-dimensionally printed drill guide on the accuracy of pedicle screw placement in lumbosacral vertebrae: An ex vivo study.,"OBJECTIVE To compare the accuracy of pedicle screw insertion (PSI) into canine lumbosacral vertebrae with custom-made three-dimensionally (3D)-printed drill guides or freehand insertion. STUDY DESIGN Ex vivo study. SAMPLE POPULATION Nineteen canine lumbosacral specimens. METHODS Drill guides for PSI were designed on the basis of safe screw insertion trajectories by using preoperative computed tomography (CT) and produced by 3D printing of templates. Right and left sides of the specimens were randomly allocated to two groups; 4-mm pedicle screws were inserted in L5-L6 and L7-S1 spinal segments either freehand (control group) or with custom-made drill guides (guide group). Sixty-six screws were inserted with each method. Insertion angles (α, β), bone stock, and vertebral canal breach were assessed according to postoperative CT. χ 2 Tests were used to compare vertebral canal breach between groups and vertebrae. RESULTS Breaches in the vertebral canal were less common (P < .001) when screws were placed with a guide in the guide group (9/66, 14%) than without a guide (30/66, 45%). The rate of vertebral canal breach differed at L5 (P = .021) but not at L6 (P = .05), L7 (P = .075) or S1 (P = .658). The angle of insertion (α) did not differ between specimens with and without breaches (guide, P = .068; control, P = .394). CONCLUSION The use of a customized 3D-printed guide generally improved the accuracy of PSI in canine lumbosacral vertebrae, although statistical significance was reached only at L5. CLINICAL SIGNIFICANCE The use of customized drill guides may be considered as an alternative to freehand PSI in the lumbosacral area, especially for L5-L6 vertebrae.",2020,"The rate of vertebral canal breach differed at L5 (P = .021) but not at L6 (P = .05), L7 (P = .075) or S1 (P = .658).","['Nineteen canine lumbosacral specimens', 'lumbosacral vertebrae']","['preoperative computed tomography (CT', '4-mm pedicle screws were inserted in L5-L6 and L7-S1 spinal segments either freehand (control group) or with custom-made drill guides (guide group', 'pedicle screw insertion (PSI) into canine lumbosacral vertebrae with custom-made three-dimensionally (3D)-printed drill guides or freehand insertion', 'pedicle screw placement']","['rate of vertebral canal breach', 'accuracy of PSI in canine lumbosacral vertebrae', 'vertebral canal breach', 'Insertion angles (α, β), bone stock, and vertebral canal breach', 'angle of insertion (α']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0223603', 'cui_str': 'Structure of lumbosacral vertebrae'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0223603', 'cui_str': 'Structure of lumbosacral vertebrae'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0223603', 'cui_str': 'Structure of lumbosacral vertebrae'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}]",66.0,0.0278726,"The rate of vertebral canal breach differed at L5 (P = .021) but not at L6 (P = .05), L7 (P = .075) or S1 (P = .658).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Beer', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Steffen', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Decvn Lucas A', 'Initials': 'DLA', 'LastName': 'Smolders', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pozzi', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sebastian C', 'Initials': 'SC', 'LastName': 'Knell', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}]",Veterinary surgery : VS,['10.1111/vsu.13417'] 444,30557562,Population Pharmacokinetic and Exposure-Response Analyses of Baloxavir Marboxil in Adults and Adolescents Including Patients With Influenza.,"Baloxavir marboxil, a prodrug that is metabolized to baloxavir acid, suppresses viral replication by inhibiting cap-dependent endonuclease. Our aim is to characterize its pharmacokinetics and exposure-response relationships. Population pharmacokinetic analysis of the baloxavir acid was performed using 8310 plasma concentration data points from 1109 subjects. Exposure-response analyses were performed regarding the time to alleviation of symptoms and the reduction in the influenza virus titer. A 2-compartment model with first-order absorption and lag time well described the plasma concentration data for baloxavir acid, and body weight and race were found to be the most important factors influencing the clearance and distribution volume. A dose regimen based on the body weight (40 mg for patients weighing <80 kg and 80 mg for patients weighing ≥80 kg) could provide sufficient exposures for expecting efficacy irrespective of body weight or race; however, the exposures were dependent on the body weight and race. Exposure-response analyses suggested that the reduction in the influenza virus titer was greater in any exposure-based groups in baloxavir marboxil treatment than in the oseltamivir phosphate treatment and placebo groups. In conclusion, the population pharmacokinetic model and exposure-response relationships would be useful for understanding the pharmacokinetic and pharmacodynamic characteristics of baloxavir acid.",2019,Exposure-response analyses suggested that the reduction in the influenza virus titer was greater in any exposure-based groups in baloxavir marboxil treatment than in the oseltamivir phosphate treatment and placebo groups.,"['1109 subjects', 'Adults and Adolescents Including Patients With Influenza']","['baloxavir acid', 'Baloxavir Marboxil']",['influenza virus titer'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.0178517,Exposure-response analyses suggested that the reduction in the influenza virus titer was greater in any exposure-based groups in baloxavir marboxil treatment than in the oseltamivir phosphate treatment and placebo groups.,"[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Koshimichi', 'Affiliation': 'Project Management Department, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tsuda', 'Affiliation': 'Project Management Department, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishibashi', 'Affiliation': 'Project Management Department, Shionogi & Co., Ltd, Osaka, Japan. Electronic address: toru.ishibashi@shionogi.co.jp.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Wajima', 'Affiliation': 'Project Management Department, Shionogi & Co., Ltd, Osaka, Japan.'}]",Journal of pharmaceutical sciences,['10.1016/j.xphs.2018.12.005'] 445,30586008,Haptoglobin 2 Allele is Associated With Histologic Response to Vitamin E in Subjects With Nonalcoholic Steatohepatitis.,"BACKGROUND Haptoglobin (Hp) genotype has been linked to oxidative stress and cardiovascular outcomes in response to vitamin E (VitE) among patients with diabetes mellitus. Its effect on histologic response to VitE in nonalcoholic steatohepatitis (NASH) is unknown. GOALS Our objective was to determine if Hp genotype associates with response to VitE in patients with NASH. STUDY A post hoc analysis of 228 patients receiving VitE or placebo in 2 clinical trials was performed. Regression analysis was used to assess the effect of VitE versus placebo, by Hp genotype (1-1, 2-1, or 2-2), on histologic features and laboratory markers of nonalcoholic fatty liver disease, comparing baseline to end of treatment values. An interaction term was included in the regression models to assess differential treatment effect across Hp genotype. RESULTS Hp 2-2 patients treated with VitE versus placebo showed significant histologic improvement (51% vs. 20%; OR=4.2; P=0.006), resolution of steatohepatitis (44% vs. 12%; OR=6.2; P=0.009), decrease in nonalcoholic fatty liver disease Activity Score (NAS) (-2.2 vs. -0.6; P=0.001), and decrease in liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyl transpeptidase. Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes. Hp 1-1 patients showed no significant improvement in histology or liver enzymes. VitE had no effect on fibrosis stage in any group. Regression analysis showed incremental benefit of having Hp 2-2 or 2-1 versus 1-1 for all liver enzyme. CONCLUSIONS Hp 2 allele is associated with greater histologic and biological improvement in NASH with VitE treatment compared with the Hp 1 allele.",2019,"Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes.","['patients with NASH', '228 patients receiving VitE or', 'patients with diabetes mellitus', 'Subjects With Nonalcoholic Steatohepatitis']","['vitamin E (VitE', 'VitE versus placebo', 'Vitamin E', 'placebo']","['resolution of steatohepatitis, NAS and liver enzymes', 'nonalcoholic fatty liver disease Activity Score (NAS', 'histology or liver enzymes', 'fibrosis stage', 'histologic improvement', 'resolution of steatohepatitis', 'liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyl transpeptidase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}]",228.0,0.342091,"Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes.","[{'ForeName': 'Bubu A', 'Initials': 'BA', 'LastName': 'Banini', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Cazanave', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Amon', 'Initials': 'A', 'LastName': 'Asgharpour', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vincent', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Faridoddin', 'Initials': 'F', 'LastName': 'Mirshahi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Le', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Contos', 'Affiliation': 'Division of Surgical Pathology, Department of Pathology, VCU School of Medicine, Richmond, VA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Naga P', 'Initials': 'NP', 'LastName': 'Chalasani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Indiana Fatty Liver Disease Research Group, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Care Network, Swedish Medical Center, Seattle, WA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'Department of Pathology, Sharp Health System.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001142'] 446,32067625,Propranolol Reduces Portal Vein Diameter in Schistosomal Liver Disease with Portal Hypertension: A Prospective Cohort Study.,"Hepatosplenic schistosomiasis (HSS) complicates portal hypertension, leading to life-threatening variceal bleeding. Variceal bleeding is associated with increased portal vein diameter (PVD). Beta-blockers prevent variceal bleeding. It is unclear whether beta-blockers such as propranolol can reduce PVD in HSS. We aimed to explore the effect of propranolol on PVD in HSS. A longitudinal study was conducted at the University Teaching Hospital, Zambia, as an extension of a clinical trial of rifaximin undertaken to test the hypothesis that rifaximin could reduce bacterial translocation in HSS. We randomized 85 adults to either rifaximin and standard care, or propranolol-based standard care only for 42 days. We then followed up all the patients on propranolol up to day 180. We used ultrasound to measure PVD at baseline and day 180. The primary outcome was reduction in PVD. Beta-blockade and splenic size reduction were secondary outcomes. Portal vein diameter reduced after 180 days of propranolol therapy from median 12 mm (interquartile range (IQR): 11-14) to median 10 mm (IQR: 9-13) ( P < 0.001). The pulse rate reduced from baseline median 70 beats/minute (IQR: 66-80) to 65 beats/minute (IQR: 60-70) by day 180 ( P = 0.006). Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001). Splenic size remained unchanged. Propranolol led to the reduction in PVD over 180 days. This suggests that ultrasound could be useful in monitoring response and compliance to beta-blockers, especially in resource-constraint areas where portal hypertension measurement facilities are unavailable.",2020,Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001).,"['Schistosomal Liver with Portal Hypertension', '85 adults to either']","['Propranolol', 'rifaximin and standard care, or propranolol-based standard care', 'Beta-blockers', 'propranolol']","['reduction in PVD', 'Portal vein diameter', 'Hemoglobin levels', 'Beta-blockade and splenic size reduction', 'portal vein diameter (PVD', 'Splenic size', 'variceal bleeding', 'Variceal bleeding', 'Portal Vein Diameter', 'pulse rate']","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}]",85.0,0.142688,Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001).,"[{'ForeName': 'Edford', 'Initials': 'E', 'LastName': 'Sinkala', 'Affiliation': 'Department of Internal Medicine, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vinikoor', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Kanekwa', 'Initials': 'K', 'LastName': 'Zyambo', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Besa', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bright', 'Initials': 'B', 'LastName': 'Nsokolo', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0452'] 447,30937431,Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy.,"BACKGROUND The National Lung Screening Trial showed that lung cancer (LC) screening by three annual rounds of low-dose computed tomography (LDCT) reduces LC mortality. We evaluated the benefit of prolonged LDCT screening beyond 5 years, and its impact on overall and LC specific mortality at 10 years. DESIGN The Multicentric Italian Lung Detection (MILD) trial prospectively randomized 4099 participants, to a screening arm (n = 2376), with further randomization to annual (n = 1190) or biennial (n = 1186) LDCT for a median period of 6 years, or control arm (n = 1723) without intervention. Between 2005 and 2018, 39 293 person-years of follow-up were accumulated. The primary outcomes were 10-year overall and LC specific mortality. Landmark analysis was used to test the long-term effect of LC screening, beyond 5 years by exclusion of LCs and deaths that occurred in the first 5 years. RESULTS The LDCT arm showed a 39% reduced risk of LC mortality at 10 years [hazard ratio (HR) 0.61; 95% confidence interval (CI) 0.39-0.95], compared with control arm, and a 20% reduction of overall mortality (HR 0.80; 95% CI 0.62-1.03). LDCT benefit improved beyond the 5th year of screening, with a 58% reduced risk of LC mortality (HR 0.42; 95% CI 0.22-0.79), and 32% reduction of overall mortality (HR 0.68; 95% CI 0.49-0.94). CONCLUSIONS The MILD trial provides additional evidence that prolonged screening beyond 5 years can enhance the benefit of early detection and achieve a greater overall and LC mortality reduction compared with NLST trial. CLINICALTRIALS.GOV IDENTIFIER NCT02837809.",2019,"The LDCT arm showed a 39% reduced risk of LC mortality at 10 years (HR 0.61, 95%CI 0.39-0.95), compared with control arm, and a 20% reduction of overall mortality (HR: 0.80, 95%CI 0.62-1.03).","['Between 2005 and 2018, 39,293 person-years of follow-up were accumulated', 'The Multicentric Italian Lung Detection (MILD) trial prospectively randomized 4,099 participants, to a screening arm (n\u2009=\u20092,376), with further randomization to annual (n\u2009=\u20091190) or biennial (n\u2009=\u20091186']","['low-dose computed tomography (LDCT', 'LDCT']","['risk of LC mortality', 'lung cancer mortality', 'overall mortality', '10-year Mortality', 'LDCT benefit', '10-year overall and LC specific mortality', 'overall and LC specific mortality']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439743', 'cui_str': 'Multicentric (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",4099.0,0.364185,"The LDCT arm showed a 39% reduced risk of LC mortality at 10 years (HR 0.61, 95%CI 0.39-0.95), compared with control arm, and a 20% reduction of overall mortality (HR: 0.80, 95%CI 0.62-1.03).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pastorino', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan. Electronic address: ugo.pastorino@istitutotumori.mi.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan; Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sestini', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sabia', 'Affiliation': 'Unit of Thoracic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeri', 'Affiliation': 'Tumour Genomics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cantarutti', 'Affiliation': 'Division of Biostatistics, Department of Statistics and Quantitative Methods, Epidemiology and Public Health, University of Milano-Bicocca, Milan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sverzellati', 'Affiliation': 'Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sozzi', 'Affiliation': 'Tumour Genomics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Corrao', 'Affiliation': 'Division of Biostatistics, Department of Statistics and Quantitative Methods, Epidemiology and Public Health, University of Milano-Bicocca, Milan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchianò', 'Affiliation': 'Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz117'] 448,31518936,Examining the relationship between household air pollution and infant microbial nasal carriage in a Ghanaian cohort.,"BACKGROUND Pneumonia, a leading cause of childhood mortality, is associated with household air pollution (HAP) exposure. Mechanisms between HAP and pneumonia are poorly understood, but studies suggest that HAP may increase the likelihood of bacterial, instead of viral, pneumonia. We assessed the relationship between HAP and infant microbial nasal carriage among 260 infants participating in the Ghana Randomized Air Pollution and Health Study (GRAPHS). METHODS Data are from GRAPHS, a cluster-randomized controlled trial of cookstove interventions (improved biomass or LPG) versus the 3-stone (baseline) cookstove. Infants were surveyed for pneumonia during the first year of life and had routine personal exposure assessments. Nasopharyngeal swabs collected from pneumonia cases (n = 130) and healthy controls (n = 130) were analyzed for presence of 22 common respiratory microbes by MassTag polymerase chain reaction. Data analyses included intention-to-treat (ITT) comparisons of microbial species presence by study arm, and exposure-response relationships. RESULTS In ITT analyses, 3-stone arm participants had a higher mean number of microbial species than the LPG (LPG: 2.71, 3-stone: 3.34, p < 0.0001, n = 260). This difference was driven by increased bacterial (p < 0.0001) rather than viral species presence (non-significant). Results were pronounced in pneumonia cases and attenuated in healthy controls. Higher prevalence bacterial species were Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Exposure-response relationships did not yield significant associations between measured CO and nasal microbial carriage. CONCLUSIONS Our intention-to-treat findings are consistent with a link between HAP and bacterial nasal carriage. No relationships were found for viral carriage. Given the null results in exposure-response analysis, it is likely that a pollutant besides CO is driving these differences.",2019,This difference was driven by increased bacterial (p < 0.0001) rather than viral species presence (non-significant).,"['Nasopharyngeal swabs collected from pneumonia cases (n\u202f=\u202f130) and healthy controls (n\u202f=\u202f130) were analyzed for presence of 22 common respiratory microbes by MassTag polymerase chain reaction', '260 infants participating in the Ghana Randomized Air Pollution and Health Study (GRAPHS']",['cookstove interventions (improved biomass or LPG'],"['viral carriage', 'mean number of microbial species', 'CO and nasal microbial carriage']","[{'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0001873', 'cui_str': 'Air Pollution'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}]",260.0,0.117689,This difference was driven by increased bacterial (p < 0.0001) rather than viral species presence (non-significant).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carrión', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA. Electronic address: daniel.carrion@mssm.edu.'}, {'ForeName': 'Seyram', 'Initials': 'S', 'LastName': 'Kaali', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Patrick L', 'Initials': 'PL', 'LastName': 'Kinney', 'Affiliation': 'Department of Environmental Health, Boston University, Boston, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'University of Health and Allied Sciences, Ho, Ghana.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chillrud', 'Affiliation': 'Lamont-Doherty Earth Observatory, Columbia University, New York, USA.'}, {'ForeName': 'Abena K', 'Initials': 'AK', 'LastName': 'Yawson', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Ashlinn', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'Fogarty International Center, National Institutes of Health, Bethesda, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Wylie', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ae-Ngibise', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Tokarz', 'Affiliation': 'Center for Infection and Immunity, Columbia University, New York, USA.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Iddrisu', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Darby W', 'Initials': 'DW', 'LastName': 'Jack', 'Affiliation': 'Department of Environmental Health Sciences, Columbia University, New York, USA. Electronic address: daniel.dj2183@columbia.edu.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}]",Environment international,['10.1016/j.envint.2019.105150'] 449,31368793,Facilitators and barriers to successful recruitment into a large comparative effectiveness trial: a qualitative study.,"Background: Recruitment of participants into research studies, especially individuals from minority groups, is challenging; lack of diversity may lead to biased findings. Aim: To explore beliefs about research participation among individuals who were approached and eligible for the GRADE study. Methods: In-depth qualitative telephone interviews with randomized participants (n = 25) and eligible individuals who declined to enroll (n = 26). Results: Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation. Few participants understood how comparative effectiveness research differed from other types of trials; however, some features of comparative effectiveness research were perceived as lower risk. Conclusion: We identified facilitators and addressable barriers to participation in research studies.",2019,"Results: Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","['randomized participants (n\xa0=\xa025) and eligible individuals who declined to enroll (n\xa0=\xa026', 'participants into research studies, especially individuals from minority groups', 'individuals who were approached and eligible for the GRADE study']",[],"['trust and perceptions of risk, benefits and burden of participation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035168'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",[],"[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.150427,"Results: Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Behringer-Massera', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Bone Diseases, Icahn School of Medicine, 1 Gustave L Levy Place, NY 10029, USA.'}, {'ForeName': 'Terysia', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Geny', 'Initials': 'G', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Duran', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL 35294, USA.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of comparative effectiveness research,['10.2217/cer-2019-0010'] 450,31020334,Prognostic value of circulating tumour cells in limited-stage small-cell lung cancer: analysis of the concurrent once-daily versus twice-daily radiotherapy (CONVERT) randomised controlled trial.,"BACKGROUND The clinical significance of circulating tumour cells (CTCs) in limited-stage small-cell lung cancer (LS-SCLC) is not well defined. We report a planned exploratory analysis of the prevalence and prognostic value of CTCs in LS-SCLC patients enrolled within the phase III randomised CONVERT (concurrent once-daily versus twice-daily chemoradiotherapy) trial. PATIENTS AND METHODS Baseline blood samples were enumerated for CTCs using CellSearch in 75 patients with LS-SCLC who were enrolled in the CONVERT trial and randomised between twice- and once-daily concurrent chemoradiation. Standard statistical methods were used for correlations of CTCs with clinical factors. Log-rank test and Cox regression analyses were applied to establish the associations of 2, 15 and 50 CTC thresholds with progression-free survival (PFS) and overall survival (OS). An optimal CTC count threshold for LS-SCLC was established. RESULTS CTCs were detected in 60% (45/75) of patients (range 0-3750). CTC count thresholds of 2, 15 and 50 CTCs all significantly correlate with PFS and OS. An optimal CTC count threshold in LS-SCLC was established at 15 CTCs, defining 'favourable' and 'unfavourable' prognostic risk groups. The median OS in <15 versus ≥15 CTCs was 26.7 versus 5.9 m (P = 0.001). The presence of ≥15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients. CONCLUSION We report the prognostic value of baseline CTC count in an exclusive LS-SCLC population at thresholds of 2, 15 and 50 CTCs. Specific to LS-SCLC, ≥15 CTCs was associated with worse PFS and OS independent of all other factors and predicted ≤2 years survival. These results may improve disease stratification in future clinical trial designs and aid clinical decision making. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00433563.",2019,"The presence of ≥ 15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients. ","['Baseline blood samples were enumerated for CTCs using CellSearch in 75 patients with LS-SCLC who were enrolled in the CONVERT trial and randomised between', 'limited-stage small cell lung cancer', 'LS-SCLC patients enrolled within the phase 3 randomised CONVERT trial']",['twice- and once-daily concurrent chemoradiation'],"['progression-free (PFS) and overall survival (OS', 'PFS and OS', 'CTC count thresholds', 'median OS']","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",75.0,0.168964,"The presence of ≥ 15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients. ","[{'ForeName': 'R Y', 'Initials': 'RY', 'LastName': 'Tay', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fernández-Gutiérrez', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Foy', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Burns', 'Affiliation': 'Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pierce', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Morris', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Priest', 'Affiliation': 'Clinical and Experimental Pharmacology Group, CRUK Manchester Institute.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tugwood', 'Affiliation': 'Cancer Research UK Manchester Institute; Manchester Centre for Cancer Biomarker Sciences, University of Manchester, Manchester.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ashcroft', 'Affiliation': 'Manchester Academic Health Science Centre Trials Co-ordination Unit.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Lindsay', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester; Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health; Department of Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dive', 'Affiliation': 'Cancer Research UK Manchester Institute; Manchester Centre for Cancer Biomarker Sciences, University of Manchester, Manchester.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Blackhall', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester; Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health. Electronic address: fiona.blackhall@christie.nhs.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz122'] 451,31261373,Placental pathology and neonatal brain MRI in a randomized trial of erythropoietin for hypoxic-ischemic encephalopathy.,"BACKGROUND Newborns with hypoxic-ischemic encephalopathy (HIE) may exhibit abnormalities on placental histology. In this phase II clinical trial ancillary study, we hypothesized that placental abnormalities correlate with MRI brain injury and with response to treatment. METHODS Fifty newborns with moderate/severe encephalopathy who received hypothermia were enrolled in a double-blind, placebo-controlled trial of erythropoietin for HIE. A study pathologist reviewed all available clinical pathology reports to determine the presence of chronic abnormalities and acute chorioamnionitis. Neonatal brain MRIs were scored using a validated HIE scoring system. RESULTS Placental abnormalities in 19 of the 35 (54%) patients with available pathology reports included chronic changes (N = 13), acute chorioamnionitis (N = 9), or both (N = 3). MRI subcortical brain injury was less common in infants with a placental abnormality (26 vs. 69%, P = 0.02). Erythropoietin treatment was associated with a lower global brain injury score (median 2.0 vs. 11.5, P = 0.003) and lower rate of subcortical brain injury (33 vs. 90%, P = 0.01) among patients with no chronic placental abnormality but not in patients whose placentas harbored a chronic abnormality. CONCLUSION Erythropoietin treatment was associated with less brain injury only in patients whose placentas exhibited no chronic histologic changes. Placentas may provide clues to treatment response in HIE.",2020,"Erythropoietin treatment was associated with a lower global brain injury score (median 2.0 vs. 11.5, P = 0.003) and lower rate of subcortical brain injury (33 vs. 90%, P = 0.01) among patients with no chronic placental abnormality but not in patients whose placentas harbored a chronic abnormality. ","['Placental abnormalities in 19 of the 35 (54%) patients with available pathology reports included', 'Newborns with hypoxic-ischemic encephalopathy (HIE', 'hypoxic-ischemic encephalopathy', 'Fifty newborns with moderate/severe encephalopathy who received hypothermia']","['erythropoietin for HIE', 'Erythropoietin', 'placebo', 'erythropoietin']","['chronic histologic changes', 'Neonatal brain MRIs', 'chronic changes', 'global brain injury score', 'MRI subcortical brain injury', 'rate of subcortical brain injury']","[{'cui': 'C1306893', 'cui_str': 'Placental abnormality (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0807321', 'cui_str': 'Pathology report (record artifact)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathies'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",50.0,0.122361,"Erythropoietin treatment was associated with a lower global brain injury score (median 2.0 vs. 11.5, P = 0.003) and lower rate of subcortical brain injury (33 vs. 90%, P = 0.01) among patients with no chronic placental abnormality but not in patients whose placentas harbored a chronic abnormality. ","[{'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA. WuY@ucsf.edu.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Goodman', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Department of Neurology, Children's National Health Systems, Washington, DC, USA.""}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ""Department of Neurology, Children's National Health Systems, Washington, DC, USA.""}, {'ForeName': 'Fernando F', 'Initials': 'FF', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Mathur', 'Affiliation': 'Departments of Pediatrics, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Krisa', 'Initials': 'K', 'LastName': 'Van Meurs', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'McKinstry', 'Affiliation': 'Department of Radiology, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Redline', 'Affiliation': 'Department of Pathology, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Pediatric research,['10.1038/s41390-019-0493-6'] 452,31913191,Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.,"OBJECTIVES Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography, but conventional cannulation methods (CCMs) have a postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aim of this study was to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. METHODS A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of 2 groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. RESULTS The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in 8 patients in the CCM group and in no patients in the NKF group (9.2% vs 0%, P < 0.001). The rates of other adverse events did not differ between the groups. The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP. However, the mean cannulation and total procedural times were longer in the NKF group than in the CCM group. DISCUSSION NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. ClinicalTrials.gov, NCT02916199.",2020,"The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP.","['High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis', '207 patients with one or more risk factors for PEP were prospectively enrolled', 'patients at high risk for developing PEP']","['primary biliary cannulation technique (NKF or CCM', 'Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method', 'needle-knife fistulotomy (NKF', 'CCM', 'NKF']","['PEP', 'mean cannulation and total procedural times', 'biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP', 'mean number of PEP risk factors', 'rates of other adverse events', 'effectiveness and safety', 'biliary cannulation success rate']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0181464', 'cui_str': 'Pre-cut needle knife'}, {'cui': 'C0744044', 'cui_str': 'Fistulotomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",207.0,0.0445235,"The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP.","[{'ForeName': 'Sung Ill', 'Initials': 'SI', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Uk', 'Initials': 'DU', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Pusan, South Korea.'}, {'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Seok', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Jin-Seok', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Don Haeng', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Chang-Il', 'Initials': 'CI', 'LastName': 'Kwon', 'Affiliation': 'Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.'}, {'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, South Korea.'}, {'ForeName': 'Se Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, South Korea.'}, {'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Korea.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000480'] 453,32251265,Blood-based biomarkers for prediction of intracranial hemorrhage and outcome in patients with moderate or severe traumatic brain injury.,"BACKGROUND Early identification of traumatic intracranial hemorrhage (ICH) has implications for triage and intervention. Blood-based biomarkers were recently approved by the Food and Drug Administration (FDA) for prediction of ICH in patients with mild traumatic brain injury (TBI). We sought to determine if biomarkers measured early after injury improve prediction of mortality and clinical/radiologic outcomes compared with Glasgow Coma Scale (GCS) alone in patients with moderate or severe TBI (MS-TBI). METHODS We measured glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), and microtubule-associated protein-2 (MAP-2) on arrival to the emergency department (ED) in patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS score, 3-12; SPB, > 90). Biomarkers were modeled individually and together with prehospital predictor variables [PH] (GCS score, age, sex). Data were divided into a training data set and test data set for model derivation and evaluation. Models were evaluated for prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended (GOS-E) and Disability Rating Scale (DRS). Area under the curve (AUC) was evaluated in test data for PH alone, PH + individual biomarkers, and PH + three biomarkers. RESULTS Of 243 patients with baseline samples (obtained a median of 84 minutes after injury), prehospital GCS score was 8 (interquartile range, 5-10), 55% had ICH, and 48-hour and 28-day mortality were 7% and 13%, respectively. Poor neurologic outcome at 6 months was observed in 34% based on GOS-E of 4 or less, and 24% based on DRS greater than or equal to7. Addition of each biomarker to PH improved AUC in the majority of predictive models. GFAP+PH compared with PH alone significantly improved AUC in all models (ICH, 0.82 vs. 0.64; 48-hour mortality, 0.84 vs. 0.71; 28-day mortality, 0.84 vs. 0.66; GOS-E, 0.78 vs. 0.69; DRS, 0.84 vs. 0.81, all p < 0.001). CONCLUSION Circulating blood-based biomarkers may improve prediction of neurological outcomes and mortality in patients with MS-TBI over prehospital characteristics alone. Glial fibrillary acidic protein appears to be the most promising. Future evaluation in the prehospital setting is warranted. LEVEL OF EVIDENCE Prospective, Prognostic and Epidemiological, level II.",2020,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001]. ","['patients with mild TBI', 'traumatic intracranial hemorrhage (ICH', '243 patients with baseline samples', 'patients with moderate or severe TBI (MS-TBI', 'patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS 3-12, SPB > 90', 'patients with MS-TBI over prehospital characteristics alone']","['GCS', 'GFAP', 'GFAP+PH']","['AUC', 'prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended [GOSE] and Disability Rating Scale [DRS', 'Poor neurologic outcome', 'glial-fibrillary-acidic-protein (GFAP), ubiquitin-C-terminal-hydrolase-L1 (UCH-L1), and microtubule-associated-protein-2 (MAP-2', 'prehospital GCS', 'mortality and clinical/radiologic outcomes', 'ICH, and 48-hr and 28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0273058', 'cui_str': 'Intracranial hemorrhage following injury'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0597729', 'cui_str': 'Spindle Pole Body'}, {'cui': 'C0439083', 'cui_str': '>90'}]","[{'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0451125', 'cui_str': 'Disability rating scale'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0164005', 'cui_str': 'Ubiquitin thiolesterase'}, {'cui': 'C1436157', 'cui_str': 'UCHL1 protein, human'}, {'cui': 'C0024773', 'cui_str': 'MAP2 Microtubule-Associated Protein'}, {'cui': 'C1433609', 'cui_str': 'METAP2 protein, human'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}]",243.0,0.0609947,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001]. ","[{'ForeName': 'Taylor N', 'Initials': 'TN', 'LastName': 'Anderson', 'Affiliation': 'From the School of Medicine (T.N.A.), Department of Neurology (H.E.H.), Department of Surgery (S.E.R.), Oregon Health and Science University, Portland, Oregon; Department of Biostatistics (J.H.), University of Washington, Seattle, Washington; College of Pharmacy (M.M.), Oregon State University, Corvallis, Oregon; Department of Emergency Medicine (L.P.), Orlando Regional Medical Center, Orlando, Florida; Department of Surgery (A.V.), Mercer University School of Medicine, Macon, Georgia; and Department of Surgery (S.E.R.), Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Munar', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vaughan', 'Affiliation': ''}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002706'] 454,32084445,Reducing cardiovascular risk among people living with HIV: Rationale and design of the INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) randomized controlled trial.,"Cardiovascular disease (CVD) is a major cause of morbidity among people living with HIV (PLWH). Statins can safely and effectively reduce CVD risk in PLWH, but evidence-based statin therapy is under-prescribed in PLWH. Developed using an implementation science framework, INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) is a stepped-wedge cluster randomized trial that addresses organization-, clinician- and patient-level barriers to statin uptake in Los Angeles community health clinics serving racially and ethnically diverse PLWH. After assessing knowledge about statins and barriers to clinician prescribing and patient uptake, we will design, implement and measure the effectiveness of (1) educational interventions targeting leadership, clinicians, and patients, followed by (2) behavioral economics-informed clinician feedback on statin uptake. In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.",2020,"In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.","['people living with HIV', 'people living with HIV (PLWH']",['Statin'],"['clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation', 'cardiovascular risk']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",2.0,0.0964372,"In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.","[{'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Takada', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Ober', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'UCLA Anderson School of Management, Los Angeles, CA, USA; Department of Psychology, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Tamara B', 'Initials': 'TB', 'LastName': 'Horwich', 'Affiliation': 'Division of Cardiology, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Mittman', 'Affiliation': 'Division of Health Services Research & Implementation Science, Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Shu', 'Affiliation': 'UCLA Anderson School of Management, Los Angeles, CA, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Vijayan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Wali', 'Affiliation': 'Department of Medicine, Olive View-UCLA Medical Center, Sylmar, CA, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Cunningham', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA. Electronic address: JLadapo@mednet.ucla.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.02.012'] 455,31953188,Efficacy of EUS-guided celiac plexus neurolysis compared with medication alone for unresectable pancreatic cancer in the oxycodone/fentanyl era: a prospective randomized control study.,"BACKGROUND AND AIMS The efficacy of celiac plexus neurolysis (CPN) with EUS guidance (EUS-CPN) has not been confirmed in the era of developed opioids. The aim of this study was to evaluate the efficacy of EUS-CPN for patients with pancreatic cancer-associated pain to compare medication using oxycodone and/or fentanyl with and without EUS-CPN. METHODS In this randomized control study involving patients who underwent EUS-CPN and those who did not, pain, quality of life (QOL), and opioid consumption were compared. Standard medicinal treatment using oxycodone and/or fentanyl was performed for both groups. The primary endpoint was defined as the pain evaluated by using a visual analog scale (VAS) rated from a 0 to 10, 4 weeks after the baseline. RESULTS For 48 registered patients, the outcomes of 24 patients in the EUS-CPN group and 22 patients in the control group were analyzed. EUS-CPN was successfully performed and did not induce severe procedure-related adverse events for all patients in the EUS-CPN group. Although the average pain VAS scores for both groups significantly decreased in comparison with baseline, scores were not statistically different between the groups at week 4 (1.3 ± 1.3 for the EUS-CPN group vs 2.3 ± 2.3 for the control group, P = .10). There was no statistical difference or tendency in favor of EUS-CPN at evaluation points of weeks 1, 2, 8, and 12. Moreover, the average VAS scores for QOL and the average opioid consumption between the groups were not different at all evaluation points. CONCLUSIONS EUS-CPN for patients with pancreatic cancer-associated pain did not appear to improve pain, QOL, or opioid consumption compared with those who did not undergo EUS-CPN and medicated with oxycodone/fentanyl. Although EUS-CPN can be an option, it was not found to have a large enough impact to be routinely performed for all patients with pain. (Clinical trial registration number: UMIN 000037172.).",2020,EUS-CPN was successfully performed and did not induce severe procedure-related adverse events for all patients in the EUS-CPN group.,"['patients with pancreatic cancer-associated pain', 'unresectable pancreatic cancer in the oxycodone/fentanyl era', 'patients with pain']","['oxycodone and/or fentanyl with and without EUS-CPN', 'EUS-CPN', 'oxycodone and/or fentanyl', 'EUS-guided celiac plexus neurolysis', 'EUS-guided CPN (EUS-CPN', 'medication alone', 'oxycodone/fentanyl', 'celiac plexus neurolysis (CPN) with EUS guidance']","['pain, quality of life (QOL), and opioid consumption', 'severe procedure-related adverse events', 'pain evaluated by using a 0 to10 visual analogue scale (VAS', 'pain, QOL, nor opioid consumption', 'average pain VAS scores', 'average VAS scores for QOL and the average opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0007572', 'cui_str': 'Solar Plexus'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.048173,EUS-CPN was successfully performed and did not induce severe procedure-related adverse events for all patients in the EUS-CPN group.,"[{'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Kanno', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Koshita', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Masu', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kusunose', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Toji', 'Initials': 'T', 'LastName': 'Murabayashi', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Fumisato', 'Initials': 'F', 'LastName': 'Kozakai', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, Miyagi, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.01.011'] 456,32231293,Dose-dense adjuvant chemotherapy in early breast cancer patients: 15-year results of the Phase 3 Mammella InterGruppo (MIG)-1 study.,"BACKGROUND Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown. METHODS In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS). RESULTS From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.87; p = 0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR = 0.73; 95% CI: 0.51-1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.70; 95% CI: 0.51-0.96). CONCLUSIONS Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.",2020,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","['From 1992 to 1997, 1214 patients were included', 'node-positive and high-risk node- negative breast cancer patients', 'high-risk early breast cancer patients', 'early breast cancer patients']","['adjuvant fluorouracil, epirubicin and cyclophosphamide', 'Dose-dense adjuvant chemotherapy']","['15-year OS', 'overall survival (OS), and the secondary endpoint was event-free survival (EFS', '15-year EFS']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1214.0,0.167571,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': 'Department of Oncology, Transplants and new Technologies U.O. Oncologia Medica I, Ospedale S. Chiara, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56100, Pisa, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, Ospedale San Paolo, Via Genova 30, 17100, Savona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dellepiane', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pastorino', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Levaggi', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': ""Alessia D'"", 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Buzzatti', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Molinelli', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Integrated Diagnostic Surgical Sciences, U.O. Clinica di chirurgia senologica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': 'Department of Surgical Sciences (DISC), University of Genova, Largo Rosanna Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy. lucia.delmastro@hsanmartino.it.'}]",British journal of cancer,['10.1038/s41416-020-0816-8'] 457,32250061,The influence of submerged healing abutment or subcrestal implant placement on soft tissue thickness and crestal bone stability. A 2-year randomized clinical trial.,"PURPOSE Aims of the study were: (a) to register crestal bone loss around 1.5 mm subcrestally placed implants and epicrestally placed implants with soft tissue tenting technique, (b) to record bone remodeling in subcrestal group, and (c) to determine the increase of vertical soft tissues after tenting. MATERIALS AND METHODS Thirty-two patients with vertically thin tissues of 2 mm or less received 40 submerged bone level platform-switched implants, divided into two groups-(a) 1.5 mm subcrestally placed implants and (b) epicrestally placed implants with soft tissue tenting over 2 mm healing abutments. At the second stage surgery, implants received 4 mm healing abutments, soft tissue thickness was measured in epicrestal group, and later implants were restored with zirconia-based screw-retained single restorations. Radiological images were taken at the second stage surgery, restoration delivery and after 2 years of follow-up. Bone loss was calculated as a distance between implant neck and first radiographically visible bone-to-implant contact. Bone remodeling was calculated as a distance between the bone crest and implant neck. Mann-Whitney U test was used for statistical analysis, significance set to 0.05. RESULTS After 2 years of follow-up, Group 1 (subcrestal) had 0.18 ± 0.32 mm of bone loss, Group 2 (epicrestal with 2 mm healing abutment) had 0.51 ± 0.4 mm of bone loss, with statistically significant difference (P = .001). Bone remodeling in Group 1 (subcrestal) was 1.17 ± 0.51 mm. Vertical tissue thickness in epicrestal group before the intervention was 1.85 ± 0.26 and 3.65 ± 0.41 mm after the use of 2 mm healing abutment, with a statistical difference (P = .005). CONCLUSION Subcrestal implant placement can significantly reduce crestal bone loss, compared to vertical soft tissue thickening by tenting of epicrestally placed implants, although soft tissue tenting can significantly increase soft tissue thickness.",2020,"Vertical tissue thickness in epicrestal group before the intervention was 1.85 ± 0.26 and 3.65 ± 0.41 mm after the use of 2 mm healing abutment, with a statistical difference (P = .005). ",['Thirty-two patients with vertically thin tissues of 2\u2009mm or less received'],"['40\u2009submerged bone level platform-switched implants, divided into two groups-(a) 1.5\u2009mm subcrestally placed implants and (b) epicrestally placed implants with soft tissue tenting over 2\u2009mm healing abutments', 'crestal bone loss around 1.5\u2009mm subcrestally placed implants and epicrestally placed implants with soft tissue tenting technique, (b) to record bone remodeling', 'submerged healing abutment or subcrestal implant placement', 'zirconia-based screw-retained single restorations', 'Subcrestal implant placement']","['Vertical tissue thickness', 'soft tissue thickness and crestal bone stability', 'bone loss', 'Bone loss', 'soft tissue thickness', 'crestal bone loss', 'Bone remodeling']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C3266125', 'cui_str': 'Healing abutment'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",32.0,0.0255518,"Vertical tissue thickness in epicrestal group before the intervention was 1.85 ± 0.26 and 3.65 ± 0.41 mm after the use of 2 mm healing abutment, with a statistical difference (P = .005). ","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Linkevicius', 'Affiliation': 'Institute of Odontology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Algirdas', 'Initials': 'A', 'LastName': 'Puisys', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Rokas', 'Initials': 'R', 'LastName': 'Linkevicius', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Alkimavicius', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Gineviciute', 'Affiliation': 'Private Practice, Vilnius, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linkeviciene', 'Affiliation': 'Institute of Odontology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}]",Clinical implant dentistry and related research,['10.1111/cid.12903'] 458,32045734,Effectiveness of a guided self-help exercise program tailored to patients treated with total laryngectomy: Results of a multi-center randomized controlled trial.,"OBJECTIVE To investigate the effectiveness of a guided self-help exercise program on swallowing, speech, and shoulder problems in patients treated with total laryngectomy (TL). MATERIALS AND METHODS This randomized controlled trial included patients treated with TL in the last 5 years. Patients were randomized into the intervention group (self-help exercise program with flexibility, range-of-motion and lymphedema exercises and self-care education program) or control group (self-care education program). Both groups completed measurements before and 3 and 6-months after randomization. The primary outcome was swallowing problems (SWAL-QOL). Secondary outcomes were speech problems (SHI), shoulder problems (SDQ), self-management (patient activation: PAM) and health-related quality of life (HRQOL: EORTC QLQ-C30/H&N35). Adherence was defined as moderate-high in case a patient exercised >1 per day. Linear mixed model analyses were conducted to investigate the effectiveness of the intervention and to investigate whether neck dissection, treatment indication (primary/salvage TL), time since treatment, severity of problems, and preferred format (online/booklet) moderated the effectiveness. RESULTS Moderate-high adherence to the exercise program was 59%. The intervention group (n = 46) reported less swallowing and communication problems over time compared to the control group (n = 46) (p-value = 0.013 and 0.004). No difference was found on speech, shoulder problems, patient activation and HRQOL. Time since treatment moderated the effectiveness on speech problems (p-value = 0.025): patients within 6 months after surgery benefitted most from the intervention. Being treated with a neck dissection, treatment indication, severity of problems and format did not moderate the effectiveness. CONCLUSION The guided self-help exercise program improves swallowing and communication. TRIAL REGISTRATION NTR5255.",2020,Time since treatment moderated the effectiveness on speech problems (p-value = 0.025): patients within 6 months after surgery benefitted most from the intervention.,"['patients treated with TL in the last 5\xa0years', 'patients treated with total laryngectomy', 'patients treated with total laryngectomy (TL']","['intervention group (self-help exercise program with flexibility, range-of-motion and lymphedema exercises and self-care education program) or control group (self-care education program', 'guided self-help exercise program']","['speech problems (SHI), shoulder problems (SDQ), self-management (patient activation: PAM) and health-related quality of life (HRQOL: EORTC QLQ-C30/H&N35', 'speech, shoulder problems, patient activation and HRQOL', 'Adherence', 'swallowing problems (SWAL-QOL', 'swallowing and communication problems', 'speech problems', 'swallowing, speech, and shoulder problems', 'swallowing and communication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy (procedure)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0395016', 'cui_str': 'Speech problem (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0392678', 'cui_str': 'Swallowing problem (finding)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}]",,0.0705781,Time since treatment moderated the effectiveness on speech problems (p-value = 0.025): patients within 6 months after surgery benefitted most from the intervention.,"[{'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Jansen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands; Department of Behavioural and Movement Sciences, Section Clinical Psychology, Vrije Universiteit, Amsterdam Public Health, van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands. Electronic address: f.jansen1@amsterdamumc.nl.'}, {'ForeName': 'Simone E J', 'Initials': 'SEJ', 'LastName': 'Eerenstein', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Ingrid C', 'Initials': 'IC', 'LastName': 'Cnossen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'de Bree', 'Affiliation': 'Department of Head and Neck Surgical Oncology, University Medical Cancer Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Doornaert', 'Affiliation': 'Department of Radiation Oncology, University Medical Center, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.'}, {'ForeName': 'György B', 'Initials': 'GB', 'LastName': 'Halmos', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'José A U', 'Initials': 'JAU', 'LastName': 'Hardillo', 'Affiliation': 'Department of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000 CA Rotterdam, the Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'van Hinte', 'Affiliation': 'Department of Rehabilitation, Radboud University Medical Center Nijmegen, Netherlands, PO Box 9101, 6500 HB Nijmegen, the Netherlands.'}, {'ForeName': 'Jimmie', 'Initials': 'J', 'LastName': 'Honings', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands.'}, {'ForeName': 'Cornelia F', 'Initials': 'CF', 'LastName': 'van Uden-Kraan', 'Affiliation': 'Department of Behavioural and Movement Sciences, Section Clinical Psychology, Vrije Universiteit, Amsterdam Public Health, van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands.'}, {'ForeName': 'C René', 'Initials': 'CR', 'LastName': 'Leemans', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Irma M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands; Department of Behavioural and Movement Sciences, Section Clinical Psychology, Vrije Universiteit, Amsterdam Public Health, van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104586'] 459,32105893,"Invited commentary on ""Topical 5% minoxidil versus topical 0.2% glyceryl trinitrate in treatment of chronic anal fissure: A randomized clinical trial"".",,2020,,['Chronic Anal Fissure'],['Topical 5% Minoxidil versus Topical 0.2% Glyceryl Trinitrate'],[],"[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure (disorder)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]",[],,0.0400785,,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'Formerly General Surgeon at the Kent and Sussex Hospital in Tunbridge Wells, Kent, UK. Electronic address: twill30999@aol.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.02.028'] 460,32247539,Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial.,"BACKGROUND This study investigated whether remifentanil infusion decreased intraoperative hyperglycaemia and insulin resistance compared with intermittent fentanyl administration in patients undergoing elective cardiac surgery. METHODS This was a randomised, prospective, open-label trial. Patients undergoing elective cardiac surgery (n=116) were randomised to receive either continuous intravenous remifentanil infusion or intermittent fentanyl boluses. Hourly blood glucose values were obtained for 24 h starting from induction of anaesthesia. The difference in percentage of patients with ≥2 intraoperative blood glucose concentrations >10 mM (180 mg dl -1 ) between the groups was the primary outcome measure. Secondary outcome measures included insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes. RESULTS The trial included 106 subjects in the final intention-to-treat analysis. There were fewer patients with ≥2 intraoperative blood glucose values >10 mM (180 mg dl -1 ) in the remifentanil group (17 [31.5%]) compared with the fentanyl group (33 [63.5%]) (relative risk: 0.50; 95% confidence interval [CI]: 0.32-0.77; P=0.001). The administered intraoperative insulin was a median of 8.1 units (range: 0-46.7) in the fentanyl group and 2.9 units (range: 0-35.1) in the remifentanil group (median difference=5 units; 95% CI: 1-7; P=0.004). Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines. Postoperative measures of glycaemic control and adverse clinical outcomes were not significantly different between groups. CONCLUSIONS Compared with patients treated with intermittent fentanyl, patients receiving continuous remifentanil infusion had fewer episodes of hyperglycaemia and less need for insulin administration during the intraoperative period of cardiac surgery. CLINICAL TRIAL REGISTRATION NCT02349152.",2020,"Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines.","['patients undergoing elective cardiac surgery', '106 subjects in the final intention-to-treat analysis', 'cardiac surgery', 'Patients undergoing elective cardiac surgery (n=116']","['remifentanil infusion', 'remifentanil', 'Remifentanil', 'continuous intravenous remifentanil infusion or intermittent fentanyl boluses']","['episodes of hyperglycaemia', '≥2 intraoperative blood glucose values', 'percentage of patients with ≥2 intraoperative blood glucose concentrations', 'Postoperative measures of glycaemic control and adverse clinical outcomes', 'Cortisol and adrenocorticotropic hormone', 'insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes', 'intraoperative hyperglycaemia and insulin resistance', 'perioperative glycaemic response', 'Hourly blood glucose values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",106.0,0.436534,"Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines.","[{'ForeName': 'Kathirvel', 'Initials': 'K', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: skathirvel@gmail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sciortino', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Ruppert', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Monroe', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Esper', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boisen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Marquez', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hayanga', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Badhwar', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.01.028'] 461,32057760,Identification of drought resistant miRNA in Macleaya cordata by high-throughput sequencing.,"Drought is one of the most serious factors affecting crop yields in the world. Macleaya cordata (Willd.) is a draught-tolerant medicinal plant that has been proposed as a pioneer crop to be cultivated in arid areas. However, the exact molecular mechanisms through which M. cordata responds to draught stress remain elusive. In recent years, microRNA (miRNAs) in plants have been associated with stress response. Based on these findings, the current study aimed to shed light on the potential regulatory roles of miRNAs in the draught tolerance of M. cordata by employing high-throughput RNA sequencing and degradation sequencing. Six M. cordata plants were randomly divided into two equal experiment groups, including one draught group and one control group. High-throughput sequencing of the M. cordata samples led to the identification of 895 miRNAs, of which 18 showed significantly different expression levels between the two groups. PsRobot analysis and degradation sequencing predicted the differential miRNAs to target 59 and 36 genes, respectively. Functional analysis showed that 38 of the predicted genes could be implicated in the modulation of stress response. Four miRNAs and eight target genes were selected for quantitative real-time polymerase chain reaction (qRT-PCR) validation. The expression trend of each miRNA analyzed by qRT-PCR was consistent with that determined by sequencing, and was negatively correlated with those of its target genes. The results of our current study supported the involvement of miRNAs in the draught tolerance of M. cordata and could pave the way for further investigation into the related regulatory mechanisms.",2020,"High-throughput sequencing of the M. cordata samples led to the identification of 895 miRNAs, of which 18 showed significantly different expression levels between the two groups.",['Six M. cordata plants'],[],['expression levels'],"[{'cui': 'C0032098', 'cui_str': 'Plants'}]",[],"[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0201745,"High-throughput sequencing of the M. cordata samples led to the identification of 895 miRNAs, of which 18 showed significantly different expression levels between the two groups.","[{'ForeName': 'Linlan', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'College of Horticulture and Landscape, Hunan Agricultural University, Changsha, 410128, Hunan, China. Electronic address: dolphin3024@163.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'College of Horticulture and Landscape, Hunan Agricultural University, Changsha, 410128, Hunan, China. Electronic address: zhouaa-lala@163.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Hunan Key Laboratory of Traditional Chinese Veterinary Medicine, Hunan Agricultural University, Changsha, 410128, Hunan, China; Center of Analytic Service, Hunan Agriculture University, 410208, Changsha, China. Electronic address: liuwei618@hunau.edu.cn.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Hunan Key Laboratory of Traditional Chinese Veterinary Medicine, Hunan Agricultural University, Changsha, 410128, Hunan, China; College of Horticulture and Landscape, Hunan Agricultural University, Changsha, 410128, Hunan, China. Electronic address: phuang1985@126.com.'}, {'ForeName': 'Ruolan', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Hunan Key Laboratory of Traditional Chinese Veterinary Medicine, Hunan Agricultural University, Changsha, 410128, Hunan, China; College of Horticulture and Landscape, Hunan Agricultural University, Changsha, 410128, Hunan, China. Electronic address: jrl-charge2017@163.com.'}, {'ForeName': 'Zhaoshan', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Micolta Bioresource Inc., Changsha, 410016, China. Electronic address: Tang_zhao_shan@163.com.'}, {'ForeName': 'Pi', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Hunan Key Laboratory of Traditional Chinese Veterinary Medicine, Hunan Agricultural University, Changsha, 410128, Hunan, China; College of Horticulture and Landscape, Hunan Agricultural University, Changsha, 410128, Hunan, China. Electronic address: picheng55@126.com.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Hunan Key Laboratory of Traditional Chinese Veterinary Medicine, Hunan Agricultural University, Changsha, 410128, Hunan, China; National and Local Union Engineering Research Center of Veterinary Herbal Medicine Resource and Initiative, Hunan Agricultural University, Changsha, 410128, Hunan, China. Electronic address: zengjianguo@hunau.edu.cn.'}]",Archives of biochemistry and biophysics,['10.1016/j.abb.2020.108300'] 462,30137262,Analgesic Effects Evoked by Real and Imagined Acupuncture: A Neuroimaging Study.,"Acupuncture can provide therapeutic analgesic benefits but is limited by its cost and scheduling difficulties. Guided imagery is a commonly used method for treating many disorders, such as chronic pain. The present study examined a novel intervention for pain relief that integrates acupuncture with imagery called video-guided acupuncture imagery treatment (VGAIT). A total of 27 healthy subjects were recruited for a crossover-design study that included 5 sessions administered in a randomized order (i.e., baseline and 4 different interventions). We investigated changes in pain threshold and fMRI signals modulated by: 1) VGAIT, watching a video of acupuncture previously administered on the participant's own body at baseline while imagining it being concurrently applied; 2) a VGAIT control condition, watching a video of a cotton swab touching the skin; 3) real acupuncture; and 4) sham acupuncture. Results demonstrated that real acupuncture and VGAIT significantly increased pain threshold compared with respective control groups. Imaging showed that real acupuncture produced greater activation of the insula compared with VGAIT. VGAIT produced greater deactivation at the rostral anterior cingulate cortex. Our findings demonstrate that VGAIT holds potential clinical value for pain management.",2019,VGAIT produced greater deactivation at the rostral anterior cingulate cortex.,['27 healthy subjects'],"['Acupuncture', 'VGAIT', 'real acupuncture and VGAIT', 'acupuncture with imagery called video-guided acupuncture imagery treatment (VGAIT', 'Real and Imagined Acupuncture', 'VGAIT control condition, watching a video of a cotton swab touching the skin; 3) real acupuncture; and 4) sham acupuncture']","['pain threshold', 'pain relief']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",27.0,0.157563,VGAIT produced greater deactivation at the rostral anterior cingulate cortex.,"[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Gollub', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhy190'] 463,32250730,Sporadic Angiomyolipomas Growth Kinetics While on Everolimus: Results of a Phase II Trial.,"PURPOSE Everolimus decreases tumor volume of renal angiomyolipomas in patients with tuberous sclerosis. No prospective data are available regarding the effect of everolimus on the growth kinetics in patients with sporadic angiomyolipomas. We sought to determine the safety and efficacy of everolimus in the volumetric reduction of sporadic angiomyolipomas. MATERIALS AND METHODS This multi-institutional, prospective, phase II trial, enrolled patients with 3 cm or larger sporadic angiomyolipomas who were candidates for surgical resection or percutaneous angioembolization. Patients received 10 mg everolimus daily for four planed 28-day cycles. Response was defined as a 25% or greater volumetric reduction of patient angiomyolipoma. Baseline, 4, 6 and 12-month volumetric analyses were performed using magnetic resonance imaging. Everolimus was discontinued in those with less than 25% volumetric reduction after four cycles. Those with 25% or greater volumetric reduction received 2 additional cycles. The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by 25% or more and the safety and tolerability of everolimus. RESULTS Overall 20 patients were enrolled at 5 centers. Of these patients 11 (55%) completed 4 cycles and 7 (35%) completed 6 cycles. Efficacy was demonstrated, with 10 of 18 (55.6%) patients exhibiting a 25% or greater reduction in tumor volume at 4 months (median 58.5%) and 10 of 14 (71.4%) patients exhibiting a 25% or greater reduction in tumor volume at 6 months (median 58.2%). Four (20%) patients were withdrawn due to protocol defined toxicities and 8 (40%) self-withdrew from the study due to side effects. CONCLUSIONS Everolimus was effective in causing volumetric reduction of angiomyolipomas by 25% or greater in most patients but was associated with a high rate of treatment discontinuation.",2020,"The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by ≥25% and the safety and tolerability of everolimus. ","['Sporadic Angiomyolipomas (AMLs', 'patients with sporadic angiomyolipomas', '20 patients were enrolled at 5 centers', 'patients with tuberous sclerosis', 'enrolled patients with ≥3cm sporadic angiomyolipomas who were candidates for surgical resection or percutaneous angioembolization']","['Everolimus (SAGE', 'everolimus', 'Everolimus']","['safety and tolerability of everolimus', 'efficacy of everolimus in the volumetric reduction of angiomyolipomas', 'safety and efficacy', 'tumor volume', 'toxicities', 'volumetric reduction of angiomyolipomas', 'Efficacy', 'Growth Kinetics', 'renal angiomyolipomas']","[{'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1122976', 'cui_str': 'Sage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",20.0,0.03125,"The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by ≥25% and the safety and tolerability of everolimus. ","[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Kadow', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Shuch', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Boorjian', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Surena F', 'Initials': 'SF', 'LastName': 'Matin', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rampersaud', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Barton N', 'Initials': 'BN', 'LastName': 'Milestone', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Zibelman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutikov', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Smaldone', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David Yt', 'Initials': 'DY', 'LastName': 'Chen', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Viterbo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shreyas', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Greenberg', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Malizzia', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McGowan', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Ross', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}]",The Journal of urology,['10.1097/JU.0000000000001065'] 464,32088110,Long-term outcomes comparing metabolic surgery to no surgery in patients with type 2 diabetes and body mass index 30-35.,"BACKGROUND We previously conducted a randomized study comparing metabolic surgery with medical weight management in patients with type 2 diabetes (T2D) and body mass index (BMI) 30 to 35 kg/m 2 . At 3-year follow-up, surgery was very effective in T2D remission; furthermore, in the surgical group, those with a higher baseline soluble receptor for advanced glycation end products had a lower postoperative BMI. OBJECTIVES To provide long-term follow-up of this initial patient cohort. SETTING University Hospital. METHODS Retrospective chart review was performed of the initial patient cohort. Patients lost to follow-up were systematically contacted to return to clinic for a follow-up visit. Data were compared using 2-sample t test, Fisher's exact test, or analysis of variance when applicable. RESULTS Originally, 57 patients with T2D and BMI 30 to 35 kg/m 2 were randomized to metabolic surgery (n = 29) or medical weight management (n = 28). Ten patients in the medical weight management group crossed over to surgery. Five-year follow-up data were available in 43 of 57 (75%) patients. Baseline mean BMI and glycated hemoglobin were 32.6 kg/m 2 and 7.8%, respectively. Median follow-up was 79 and 88 months in the surgical group and nonsurgical group, respectively. Compared with the nonsurgical group, the surgical patients had significantly lower rate of T2D (62% versus 100%; P = .008), lower insulin use (10% versus 50%; P = .0072), lower glycated hemoglobin (6.93% versus 8.26%; P = .012), lower BMI (25.8 versus 28.6 kg/m 2 ; P = .007), and higher percent weight loss (21.4% versus 10.3%; P = .025). Baseline soluble receptor for advanced glycation end products was not associated with long-term outcomes. CONCLUSIONS Metabolic surgery in T2D patients with BMI 30 to 35 kg/m 2 remains effective long term. Baseline soluble receptor for advanced glycation end products are most likely predictive of early outcomes only.",2020,"At 3-year follow-up, surgery was very effective in T2D remission; furthermore, in the surgical group, those with a higher baseline soluble receptor for advanced glycation end products had a lower postoperative BMI. ","['57 patients with T2D and BMI 30 to 35 kg/m 2', 'University Hospital', 'patients with type 2 diabetes (T2D) and body mass index (BMI) 30 to 35 kg/m 2 ', 'patients with type 2 diabetes and body mass index 30-35', 'T2D patients with BMI']","['metabolic surgery', 'medical weight management group crossed over to surgery', 'metabolic surgery with medical weight management', 'medical weight management', 'metabolic surgery to no surgery']","['rate of T2D', 'lower glycated hemoglobin', 'lower insulin use', 'lower BMI', 'Baseline mean BMI and glycated hemoglobin', 'percent weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0240016', 'cui_str': 'Insulin used (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",57.0,0.0698865,"At 3-year follow-up, surgery was very effective in T2D remission; furthermore, in the surgical group, those with a higher baseline soluble receptor for advanced glycation end products had a lower postoperative BMI. ","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Horwitz', 'Affiliation': 'Department of Surgery, NYU Langone Medical Center/Bellevue Hospital Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Padron', 'Affiliation': 'Department of Surgery, NYU Langone Medical Center/Bellevue Hospital Center, New York, New York.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kelly', 'Affiliation': 'Department of Surgery, NYU Langone Medical Center/Bellevue Hospital Center, New York, New York.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Saunders', 'Affiliation': 'Department of Surgery, NYU Langone Medical Center/Bellevue Hospital Center, New York, New York.'}, {'ForeName': 'Aku', 'Initials': 'A', 'LastName': 'Ude-Welcome', 'Affiliation': 'Department of Surgery, NYU Langone Medical Center/Bellevue Hospital Center, New York, New York.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Surgery, NYU Langone Medical Center/Bellevue Hospital Center, New York, New York.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Parikh', 'Affiliation': 'Department of Surgery, NYU Langone Medical Center/Bellevue Hospital Center, New York, New York. Electronic address: manish.parikh@nyumc.org.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.01.016'] 465,32245781,"Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES Large, randomized, controlled trials targeting higher hemoglobin level with erythropoiesis-stimulating agents for Western patients with CKD showed harm. However, the effect of anemia correction using erythropoiesis-stimulating agents may differ between CKD subpopulations. The Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease study, a multicenter, randomized, open-label, parallel-group study, aimed to examine the effect of targeting hemoglobin levels of 11-13 g/dl using darbepoetin alfa with reference to a low-hemoglobin target of 9-11 g/dl on kidney outcome in patients with advanced CKD without diabetes in Japan. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We enrolled 491 patients with CKD without diabetes, and an eGFR of 8-20 ml/min per 1.73 m 2 . Of these 491 patients, 239 and 240 were ultimately assigned to the high- and low-hemoglobin groups, respectively (12 patients were excluded). The primary outcome was a kidney composite end point (starting maintenance dialysis, kidney transplantation, eGFR≤6 ml/min per 1.73 m 2 , and 50% reduction in eGFR). RESULTS Mean hemoglobin levels were 11.2±1.1 and 10.0±0.9 g/dl in the high- and low-hemoglobin groups, respectively, during the mean study period of 73.5±29.7 weeks. The kidney composite end point occurred in 105 (44%) and 116 (48%) patients in the high- and low-hemoglobin groups, respectively (log-rank test; P =0.32). The adjusted Cox proportional hazards model showed that the hazard ratio for the high- versus low-hemoglobin group was 0.78 (95% confidence interval, 0.60 to 1.03; P =0.08). Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test; P =0.66). CONCLUSIONS Targeting a higher hemoglobin level (11-13 g/dl) with darbepoetin alfa did not improve kidney outcome compared with targeting a lower hemoglobin level (9-11 g/dl) in patients with advanced CKD without diabetes. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease (PREDICT), NCT01581073.",2020,"Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test; P =0.66). ","['Western patients with CKD', '491 patients, 239 and 240 were ultimately assigned to the high- and low-hemoglobin groups, respectively (12 patients were excluded', 'patients with advanced CKD without diabetes', 'patients with advanced CKD without diabetes in Japan', '491 patients with CKD without diabetes, and an eGFR of 8-20 ml/min per 1.73 m 2 ', 'CKD Patients with Non-diabetic Kidney Disease', 'Patients with Advanced CKD without Diabetes']",['Darbepoetin Alfa'],"['Mean hemoglobin levels', 'kidney outcome', 'Cardiovascular events', 'kidney composite end point', 'kidney composite end point (starting maintenance dialysis, kidney transplantation, eGFR≤6 ml/min per 1.73 m 2 , and 50% reduction in eGFR', 'hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}]","[{'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",491.0,0.121782,"Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test; P =0.66). ","[{'ForeName': 'Terumasa', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Kidney Disease and Hypertension, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Maruyama', 'Affiliation': 'Department of Nephrology, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Ichiei', 'Initials': 'I', 'LastName': 'Narita', 'Affiliation': 'Division of Clinical Nephrology and Rheumatology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Health Data Science, Translational Research Center for Medical Innovation, Kobe, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Biomedical Statistics and Bioinformatics, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Tsubakihara', 'Affiliation': 'Graduate School of Health Care Sciences, Jikei Institute, Osaka, Japan.'}, {'ForeName': 'Enyu', 'Initials': 'E', 'LastName': 'Imai', 'Affiliation': 'Nakayamadera Imai Clinic, Takarazuka, Japan ads12069@nifty.com.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.08900719'] 466,32205642,"Optimal Timing of Feeding After Endoscopic Hemostasis in Patients With Peptic Ulcer Bleeding: A Randomized, Noninferiority Trial (CRIS KCT0001019).","OBJECTIVES The optimal duration of fasting after endoscopic hemostasis in patients with peptic ulcer bleeding has not yet been determined. We investigated the appropriate timing of feeding after endoscopic hemostasis in patients with high-risk peptic ulcer bleeding. METHODS This study was a randomized, single center, noninferiority trial. Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding were randomized to resume feeding either 24 or 48 hours after successful endoscopic hemostasis. A total of 209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis. The primary outcome measure was recurrent bleeding within 7 days of hemostasis. Noninferiority testing was performed in the PP population, and the noninferiority margin was set at 10%. Secondary outcomes included 30-day rebleeding and mortality, transfusion requirements, and length of hospital stay. RESULTS Recurrent bleeding rates at 7 days were 7.9% in the 24-hour group and 4.0% in the 48-hour group in the PP analysis; tests for noninferiority did not reach statistical significance (difference: 3.9%, 95% confidence interval [CI]: -2.7 to 10.5, P value for noninferiority = 0.034). The recurrent bleeding rates within 30 days were 10.9% and 4.0% in the 24- and 48-hour groups (difference: 6.9%, 95% CI: -0.5 to 14.2), and the 30-day mortality rates were 5.9% and 14.1%, respectively (difference: -8.2%, 95% CI: -16.5 to 0.1) in the PP analysis. The transfusion requirement and the length of hospital stay were similar between the 2 groups. DISCUSSION Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding. Our results do not allow a recommendation of refeeding at 24 hours, rather than later refeeding in this population.",2020,Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding.,"['209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis', 'patients with peptic ulcer bleeding', 'Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding', 'patients with high-risk peptic ulcer bleeding', 'Patients With Peptic Ulcer Bleeding']",[],"['transfusion requirement and the length of hospital stay', 'Recurrent bleeding rates', '30-day mortality rates', '30-day rebleeding and mortality, transfusion requirements, and length of hospital stay', 'recurrent bleeding within 7 days of hemostasis', 'recurrent bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]",[],"[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",209.0,0.218447,Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding.,"[{'ForeName': 'Eun Jeong', 'Initials': 'EJ', 'LastName': 'Gong', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Baek Gyu', 'Initials': 'BG', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Hyun Il', 'Initials': 'HI', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Jong Kyu', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Koon Hee', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Young Don', 'Initials': 'YD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Gab Jin', 'Initials': 'GJ', 'LastName': 'Cheon', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Seo Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000584'] 467,31634003,Does Injection of Hyaluronic Acid Protect Against Early Cartilage Injury Seen After Marathon Running? A Randomized Controlled Trial Utilizing High-Field Magnetic Resonance Imaging.,"BACKGROUND Previous studies have shown that runners demonstrate elevated T2 and T1ρ values on magnetic resonance imaging (MRI) after running a marathon, with the greatest changes in the patellofemoral and medial compartment, which can persist after 3 months of reduced activity. Additionally, marathon running has been shown to increase serum inflammatory markers. Hyaluronic acid (HA) purportedly improves viscoelasticity of synovial fluid, serving as a lubricant while also having chondroprotective and anti-inflammatory effects. PURPOSE/HYPOTHESIS The purpose was to investigate whether intra-articular HA injection can protect articular cartilage from injury attributed to marathon running. The hypothesis was that the addition of intra-articular HA 1 week before running a marathon would reduce the magnitude of early cartilage breakdown measured by MRI. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS After institutional review board approval, 20 runners were randomized into receiving an intra-articular injection of HA or normal saline (NS) 1 week before running a marathon. Exclusionary criteria included any prior knee injury or surgery and having run >3 prior marathons. Baseline 3-T knee MRI was obtained within 48 hours before the marathon (approximately 5 days after injection). Follow-up 3-T MRI scans of the same knee were obtained 48 to 72 hours and 3 months after the marathon. The T2 and T1ρ relaxation times of articular cartilage were measured in 8 locations-the medial and lateral compartments (including 2 areas of each femoral condyle) and the patellofemoral joint. The statistical analysis compared changes in T2 and T1ρ relaxation times (ms) from baseline to immediate and 3-month postmarathon scans between the HA and NS groups with repeated measures analysis of variance. RESULTS Fifteen runners completed the study: 6 women and 2 men in the HA group (mean age, 31 years; range, 23-50 years) and 6 women and 1 man in the NS group (mean age, 27 years; range, 20-49 years). There were no gross morphologic MRI changes after running the marathon. Postmarathon studies revealed no statistically significant changes between the HA and NS groups in all articular cartilage areas of the knee on both T2 and T1ρ relaxation times. CONCLUSION Increased T2 and T1ρ relaxation times have been observed in marathon runners, suggesting early cartilage injury. The addition of intra-articular HA did not significantly affect relaxation times in all areas of the knee when compared with an NS control.",2019,"Postmarathon studies revealed no statistically significant changes between the HA and NS groups in all articular cartilage areas of the knee on both T2 and T1ρ relaxation times. ","['20 runners', 'Exclusionary criteria included any prior knee injury or surgery and having run >3 prior marathons', 'Fifteen runners completed the study: 6 women and 2 men in the HA group (mean age, 31 years; range, 23-50 years) and 6 women and 1 man in the NS group (mean age, 27 years; range, 20-49 years']","['intra-articular HA injection', 'Hyaluronic acid (HA', 'marathon running', 'High-Field Magnetic Resonance Imaging', 'intra-articular injection of HA or normal saline (NS', 'Hyaluronic Acid']","['serum inflammatory markers', 'Baseline 3-T knee MRI', 'relaxation times', 'morphologic MRI changes', 'T2 and T1ρ relaxation times of articular cartilage', 'magnitude of early cartilage breakdown']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1097281', 'cui_str': '3-(DMP)-T'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007303', 'cui_str': 'Cartilage, Articular'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}]",,0.209483,"Postmarathon studies revealed no statistically significant changes between the HA and NS groups in all articular cartilage areas of the knee on both T2 and T1ρ relaxation times. ","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Nathani', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Medicine and Shoulder Surgery, Stanford University, Redwood City, California, USA.'}, {'ForeName': 'Garry E', 'Initials': 'GE', 'LastName': 'Gold', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Medicine and Shoulder Surgery, Stanford University, Redwood City, California, USA.'}, {'ForeName': 'Uchechukwuka', 'Initials': 'U', 'LastName': 'Monu', 'Affiliation': 'Department of Bioengineering, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hargreaves', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Finlay', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Medicine and Shoulder Surgery, Stanford University, Redwood City, California, USA.'}, {'ForeName': 'Elka B', 'Initials': 'EB', 'LastName': 'Rubin', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Safran', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Medicine and Shoulder Surgery, Stanford University, Redwood City, California, USA.'}]",The American journal of sports medicine,['10.1177/0363546519879138'] 468,32170769,Bortezomib consolidation or maintenance following immunochemotherapy and autologous stem cell transplantation for mantle cell lymphoma: CALGB/Alliance 50403.,"Immunochemotherapy followed by autologous transplant (ASCT) in CALGB/Alliance 59909 achieved a median progression-free survival (PFS) in mantle cell lymphoma (MCL) of 5 years, but late recurrences occurred. We evaluated tolerability and efficacy of adding post-transplant bortezomib consolidation (BC) or maintenance (BM) to this regimen in CALGB/Alliance 50403, a randomized phase II trial. Following augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab, patients were randomized to BC (1.3 mg/m 2 IV days 1, 4, 8, 11 of a 3-week cycle for four cycles) or BM (1.6 mg/m 2 IV once weekly × 4 every 8 weeks for 18 months) beginning day 90. The primary endpoint was PFS, measured from randomization for each arm. Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow were assessed. Of 151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized. Both arms met the primary endpoint, with median PFS significantly greater than 4 years (P < .001). The 8-year PFS estimates in the BC and BM arms were 54.1% (95% CI 40.9%-71.5%) and 64.4% (95% 51.8%-79.0%), respectively. Progression-free survival was significantly longer for transplanted patients on 50403 compared with those on 59909. Both the PFS and OS were significantly better for those who were MRD-negative post-induction. The high risk proliferation signature was associated with adverse outcome. Both BM and BC were efficacious and tolerable, although toxicity was significant. The comparison between studies 50403 and 59909 with long-term follow up suggests a PFS benefit from the addition of BC or BM post- transplant.",2020,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","['151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized']","['Immunochemotherapy and Autologous Stem Cell Transplantation', 'Immunochemotherapy followed by autologous transplant (ASCT', 'adding post-transplant bortezomib consolidation (BC) or maintenance (BM', 'Bortezomib Consolidation or Maintenance', 'augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab']","['8-year PFS estimates', 'Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow', 'PFS and OS', 'toxicity', 'median progression-free survival (PFS', 'PFS', 'tolerability and efficacy', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",151.0,0.0888476,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'Medicine/Hematology-Oncology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Fulton', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pettinger', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'LaCasce', 'Affiliation': 'Medical Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Yi Tian', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hurd', 'Affiliation': 'Hematology-Oncology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'Alliance Statistics and Data Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hernandez-Ilizaliturri', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department of Medicine, Weill Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Hematology-Oncology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",American journal of hematology,['10.1002/ajh.25783'] 469,30896608,Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial.,"OBJECTIVE To evaluate biochemical and clinical effects of 2 different doses of vitamin D supplementation in preterm infants with late-onset sepsis (LOS). STUDY DESIGN A double blinded randomized controlled stratified trial included preterm infants with gestational age (GA) ≥28 weeks with LOS. Subjects were randomly assigned to receive 400 or 800 IU/day of vitamin D3. Serum concentrations of 25(OH)D, TNF-α, and IL-6 were measured at enrollment, 7 days after vitamin D supplementation, and at 40 weeks of postmenstrual age (PMA). Short-term outcomes and growth parameters were assessed. RESULTS A total of 50 infants were enrolled, 25 in each group. Seventy-six percentage of enrolled infants were vitamin D-deficient at enrollment in both groups whereas only one infant in the 400 IU and none in the 800 IU group remained deficient at 40 week's PMA; vitamin D concentrations at 40 weeks PMA were 54.8 ± 35.1 and 67.4 ± 37.1 ng/mL, respectively, P = 0.01). None of the infants enrolled in the study had signs of vitamin D toxicity. Serum pro-inflammatory cytokines IL-6 and TNF- α concentrations decreased at 1 week and at discharge in both groups without differences between groups. The 2 groups did not differ in anthropometric measurements, duration of oxygen and respiratory support, duration of antimicrobial use, length of hospital stay, and mortality. CONCLUSIONS A dose of 400 IU of vitamin D was adequate to treat vitamin D deficiency in the majority of premature infants with LOS. The 2 dosing regimens did not differ in clinical or biochemical changes.",2019,Serum pro-inflammatory cytokines IL-6 and TNF- α concentrations decreased at 1 week and at discharge in both groups without differences between groups.,"['Preterm Infants With Late-onset Sepsis', 'premature infants with LOS', 'A total of 50 infants were enrolled, 25 in each group', 'preterm infants with gestational age (GA) ≥28 weeks with LOS', 'preterm infants with late-onset sepsis (LOS']","['vitamin D', 'vitamin D supplementation', 'vitamin D3']","['vitamin D-deficient', 'Serum pro-inflammatory cytokines IL-6 and TNF- α concentrations', 'anthropometric measurements, duration of oxygen and respiratory support, duration of antimicrobial use, length of hospital stay, and mortality', 'vitamin D toxicity', 'Serum concentrations of 25(OH)D, TNF-α, and IL-6']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0242154', 'cui_str': 'Vitamin D toxicity'}]",50.0,0.588652,Serum pro-inflammatory cytokines IL-6 and TNF- α concentrations decreased at 1 week and at discharge in both groups without differences between groups.,"[{'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Abdel-Hady', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Sohier', 'Initials': 'S', 'LastName': 'Yahia', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Megahed', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Mosbah', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine-Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Basma', 'Initials': 'B', 'LastName': 'Seif', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Nageh', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Bhattacharjee', 'Affiliation': ""Department of Neonatology, Cleveland Clinic Children's Hospital, Cleveland, OH.""}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Aly', 'Affiliation': ""Department of Neonatology, Cleveland Clinic Children's Hospital, Cleveland, OH.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002238'] 470,32214382,Cervicovaginal microbiome and natural history of HPV in a longitudinal study.,"BACKGROUND Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections. However, only a small percentage of high-risk (HR) HPV infections progress to cervical precancer and cancer. In this study, we investigated the role of the cervicovaginal microbiome (CVM) in the natural history of HR-HPV. METHODS This study was nested within the placebo arm of the Costa Rica HPV Vaccine Trial that included women aged 18-25 years of age. Cervical samples from two visits of women with an incident HR-HPV infection (n = 273 women) were used to evaluate the prospective role of the CVM on the natural history of HR-HPV. We focus specifically on infection clearance, persistence, and progression to cervical intraepithelial neoplasia grade 2 and 3 (CIN2+). The CVM was characterized by amplification and sequencing the bacterial 16S V4 rRNA gene region and the fungal ITS1 region using an Illumina MiSeq platform. OTU clustering was performed using QIIME2. Functional groups were imputed using PICRUSt and statistical analyses were performed using R. RESULTS At Visit 1 (V1) abundance of Lactobacillus iners was associated with clearance of incident HR-HPV infections (Linear Discriminant Analysis (LDA)>4.0), whereas V1 Gardnerella was the dominant biomarker for HR-HPV progression (LDA>4.0). At visit 2 (V2), increased microbial Shannon diversity was significantly associated with progression to CIN2+ (p = 0.027). Multivariate mediation analysis revealed that the positive association of V1 Gardnerella with CIN2+ progression was due to the increased cervicovaginal diversity at V2 (p = 0.040). A full multivariate model of key components of the CVM showed significant protective effects via V1 genus Lactobacillus, OR = 0.41 (0.22-0.79), V1 fungal diversity, OR = 0.90 (0.82-1.00) and V1 functional Cell Motility pathway, OR = 0.75 (0.62-0.92), whereas V2 bacterial diversity, OR = 1.19 (1.03-1.38) was shown to be predictive of progression to CIN2+. CONCLUSION This study demonstrates that features of the cervicovaginal microbiome are associated with HR-HPV progression in a prospective longitudinal cohort. The analyses indicated that the association of Gardnerella and progression to CIN2+ may actually be mediated by subsequent elevation of microbial diversity. Identified features of the microbiome associated with HR-HPV progression may be targets for therapeutic manipulation to prevent CIN2+. TRIAL REGISTRATION ClinicalTrials.gov NCT00128661.",2020,"At visit 2 (V2), increased microbial Shannon diversity was significantly associated with progression to CIN2+ (p = 0.027).","['women aged 18-25 years of age', 'Cervical samples from two visits of women with an incident HR-HPV infection (n = 273 women']","['cervicovaginal microbiome (CVM', 'Costa Rica HPV Vaccine', 'placebo']","['infection clearance, persistence, and progression to cervical intraepithelial neoplasia grade 2 and 3 (CIN2', 'clearance of incident HR-HPV infections', 'HR-HPV progression', 'cervicovaginal diversity', 'microbial Shannon diversity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}]","[{'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0010182', 'cui_str': 'Costa Rica'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2 (disorder)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}]",273.0,0.0620375,"At visit 2 (V2), increased microbial Shannon diversity was significantly associated with progression to CIN2+ (p = 0.027).","[{'ForeName': 'Mykhaylo', 'Initials': 'M', 'LastName': 'Usyk', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Zolnik', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Castle', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas (ACIB), formerly Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'Prevention and Implementation Group, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gradissimo', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gonzalez', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas (ACIB), formerly Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Safaeian', 'Affiliation': 'Roche Molecular Diagnostics, Pleasanton, California, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schiffman', 'Affiliation': 'Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute, NIH, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Burk', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS pathogens,['10.1371/journal.ppat.1008376'] 471,30664564,A Phase I/IIa Trial of Intravenous Immunoglobulin Following Portoenterostomy in Biliary Atresia.,"OBJECTIVES Biliary atresia (BA) is a progressive neonatal fibroinflammatory cholangiopathy. We hypothesized that intravenous immunoglobulin (IVIg) would be safe, feasible, acceptable, and efficacious for the treatment of BA. The primary objective of this study was to establish the feasibility, acceptability, and safety profile of IVIg administration after hepatoportoenterostomy (HPE) in BA. The secondary objective was to determine the treatment efficacy of IVIg based on good bile drainage and survival with the native liver. METHODS A multicenter, prospective, open-labeled, phase I/IIA trial of IVIg was conducted, with 1 g/kg/dose of IVIg infused at 3-5, 30, and 60 days post-HPE, and subjects followed for 360 days post-HPE. Twenty-nine participants completed the study. RESULTS Administration of IVIg infusions was feasible and acceptable in 79%. None of the serious adverse events (SAEs) were directly related to IVIg infusions; however, 90% of participants had an SAE. Compared with a historical placebo-arm group, there was no significant increase in the proportion of IVIg participants with a serum total bilirubin <1.5 mg/dL at 90, 180, or 360 days post-HPE. Survival with the native liver in the IVIg participants showed no significant benefit over the historical placebo arm, with a difference at 360 days of -11.9% (IVIg: 58.6%, placebo: 70.5%; 90% UCB: 2.1%; P > 0.05). CONCLUSIONS Although IVIg infusions in infants with BA post-HPE were feasible, acceptable and safe, there was no trend to lower bilirubin levels or improved 360-day survival with the native liver. CLINICAL TRIAL Safety Study of Intravenous Immunoglobulin Post-Portoenterostomy in Biliary Atresia; #NCT01854827.",2019,"Survival with the native liver in the IVIg participants showed no significant benefit over the historical placebo arm, with a difference at 360 days of -11.9% (IVIg: 58.6%, placebo: 70.5%; 90% UCB: 2.1%; P > 0.05). ","['Biliary Atresia', 'Twenty-nine participants completed the study']","['intravenous immunoglobulin (IVIg', 'placebo', 'IVIg infusions', 'historical placebo', 'IVIg administration after hepatoportoenterostomy (HPE', 'Intravenous Immunoglobulin']","['Survival', 'bilirubin levels', 'serious adverse events (SAEs', 'feasibility, acceptability, and safety profile', 'proportion of IVIg participants with a serum total bilirubin']","[{'cui': 'C0005411', 'cui_str': 'Biliary Atresia'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032722', 'cui_str': 'Hepatoportoenterostomy'}, {'cui': 'C0640277', 'cui_str': 'HPED'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}]",29.0,0.271851,"Survival with the native liver in the IVIg participants showed no significant benefit over the historical placebo arm, with a difference at 360 days of -11.9% (IVIg: 58.6%, placebo: 70.5%; 90% UCB: 2.1%; P > 0.05). ","[{'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Mack', 'Affiliation': ""Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Estella M', 'Initials': 'EM', 'LastName': 'Alonso', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Bezerra', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Goodhue', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Vicky L', 'Initials': 'VL', 'LastName': 'Ng', 'Affiliation': 'The Hospital for Sick Children, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Saul J', 'Initials': 'SJ', 'LastName': 'Karpen', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Venkat', 'Affiliation': ""Children's Hospital of Pittsburgh, Pittsburgh.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Loomes', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Averell H', 'Initials': 'AH', 'LastName': 'Sherker', 'Affiliation': 'National Institute of Diabetes, Digestive and Kidney Diseases, NIH, Bethesda, MA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Magee', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sokol', 'Affiliation': ""Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002256'] 472,32210455,"Comparison of the pain-reducing effects of EMLA cream and of lidocaine tape during arteriovenous fistula puncture in patients undergoing hemodialysis: A multi-center, open-label, randomized crossover trial.","Arteriovenous fistula puncture pain is a serious problem for patients undergoing dialysis and a good indication for topical anesthetics. No previous study has compared lidocaine/prilocaine cream (EMLA) with lidocaine tape for pain relief during arteriovenous fistula puncture in patients undergoing maintenance hemodialysis. To this end, we conducted a multicenter randomized crossover study including 66 patients (mean age, 65.8 years; males, 57.6%) undergoing maintenance hemodialysis thrice/week. Subjects were assigned to Sequence EL (EMLA administration followed by lidocaine, with 1-week wash-out) or Sequence LE (reverse administration, first lidocaine then EMLA). All subjects completed the study. At each puncture site, 1 g EMLA (25 mg lidocaine + 25 mg prilocaine) or one sheet of lidocaine tape (18 mg lidocaine) was applied 1 h or 30 min prior to arteriovenous fistula puncture, respectively. The primary endpoint was puncture pain relief, which was measured using a 100-mm visual analog scale. The secondary endpoints included quality of life, which was measured by SF-36, and safety. EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001). However, there was no statistically significant difference in the quality of life between the two groups, and no significant carryover/period effect was observed in any analysis. Further, no drug-related adverse events were observed. Taken together, these results suggest that EMLA cream is superior to lidocaine tape for the relief of arteriovenous fistula puncture pain in patients undergoing maintenance hemodialysis. Trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN000027885).",2020,EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001).,"['patients undergoing maintenance hemodialysis', 'patients undergoing dialysis and a good indication for topical anesthetics', 'patients undergoing hemodialysis', '66 patients (mean age, 65.8 years; males, 57.6%) undergoing maintenance hemodialysis thrice/week']","['lidocaine/prilocaine cream (EMLA', 'Sequence EL (EMLA administration followed by lidocaine, with 1-week wash-out) or Sequence LE (reverse administration, first lidocaine then EMLA', 'lidocaine tape (18 mg lidocaine', 'Arteriovenous fistula puncture pain', 'EMLA', 'lidocaine + 25 mg prilocaine', 'EMLA cream', 'lidocaine tape', 'lidocaine']","['quality of life, which was measured by SF-36, and safety', 'quality of life', 'pain relief', 'puncture pain relief, which was measured using a 100-mm visual analog scale', 'arteriovenous fistula puncture pain', 'visual analog scale improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic (substance)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0617623', 'cui_str': 'Lidocaine / Prilocaine'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0360032', 'cui_str': 'EMLA Cream'}]","[{'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",66.0,0.0558131,EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001).,"[{'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Adachi', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Keiju Medical Center, Ishikawa, Japan.'}, {'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Kanazawa Medical University Himi Municipal Hospital, Toyama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': 'Honma Hospital, Yamagata, Japan.'}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Igarashi', 'Affiliation': 'Honma Hospital, Yamagata, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Uranishi', 'Affiliation': 'Anamizu General Hospital, Ishikawa, Japan.'}, {'ForeName': 'Suga', 'Initials': 'S', 'LastName': 'Sakaguchi', 'Affiliation': 'Anamizu General Hospital, Ishikawa, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Imura', 'Affiliation': 'Imura Clinic, Ishikawa, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Okino', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okushi', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kagaya', 'Affiliation': 'Keiju Medical Center, Ishikawa, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tsuruyama', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Miyatake', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Haraguchi', 'Affiliation': 'Kanazawa Medical University Himi Municipal Hospital, Toyama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Iida', 'Affiliation': 'Department of Mathematics, Kanazawa Medical University, Ishikawa Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}]",PloS one,['10.1371/journal.pone.0230372'] 473,30874803,Acceptability and Feasibility in a Pilot Randomized Clinical Trial of Computerized Working Memory Training and Parental Problem-Solving Training With Pediatric Brain Tumor Survivors.,"OBJECTIVE To evaluate the feasibility and acceptability of computerized working memory training in pediatric brain tumor survivors (PBTS) with cognitive deficits, as well as computerized working memory training that is enhanced with parental problem-solving skills training (PSST). METHODS Twenty-seven PBTS (ages 7-16) recruited from a large, tertiary academic medical center were randomly assigned to computerized working memory training (Standard; n = 14) or computerized working memory training plus PSST (Combined; n = 13). PBTS completed a baseline assessment and parents completed acceptability surveys. Primary outcomes included number of intervention sessions completed and acceptability ratings. RESULTS Fourteen of the 27 participants completed at least 20 sessions of the computerized training with average sessions lasting over an hour (M = 68.42 min, SD = 14.63). Completers had significantly better baseline auditory attention abilities than noncompleters. Parents reported both frustration and satisfaction related to the interventions and identified barriers to completing intervention sessions. CONCLUSIONS This pilot randomized clinical trial raises significant questions related to the feasibility of computerized working memory training in PBTS with cognitive deficits. Findings also offer considerations for integrating family-based treatment approaches into cognitive remediation interventions for PBTS.",2019,This pilot randomized clinical trial raises significant questions related to the feasibility of computerized working memory training in PBTS with cognitive deficits.,"['pediatric brain tumor survivors (PBTS', 'PBTS with cognitive deficits', 'Pediatric Brain Tumor Survivors', 'Twenty-seven PBTS (ages 7-16) recruited from a large, tertiary academic medical center']","['computerized working memory training', 'Computerized Working Memory Training and Parental Problem-Solving Training', 'computerized working memory training (Standard; n\u2009=\u200914) or computerized working memory training plus PSST']","['baseline auditory attention abilities', 'number of intervention sessions completed and acceptability ratings', 'frustration and satisfaction']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543432', 'cui_str': 'Problem solving training (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0016770', 'cui_str': 'Frustration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",27.0,0.0614592,This pilot randomized clinical trial raises significant questions related to the feasibility of computerized working memory training in PBTS with cognitive deficits.,"[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Hocking', 'Affiliation': ""The Children's Hospital of Philadelphia.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Paltin', 'Affiliation': ""The Children's Hospital of Philadelphia.""}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'Quast', 'Affiliation': ""The Children's Hospital of Philadelphia.""}, {'ForeName': 'Lamia P', 'Initials': 'LP', 'LastName': 'Barakat', 'Affiliation': ""The Children's Hospital of Philadelphia.""}]",Journal of pediatric psychology,['10.1093/jpepsy/jsz015'] 474,32240480,"The Effectiveness of the KiVa Bullying Prevention Program in Wales, UK: Results from a Pragmatic Cluster Randomized Controlled Trial.","The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N = 3214 students aged 7-11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n = 1588 students) and a waitlist control (usual school provision; 11 clusters, n = 1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n = 1578 children) and 10 control schools (n = 1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13.",2020,There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes.,"['22 primary schools (clusters) (N\u2009=\u20093214 students aged 7-11', '11 intervention schools (n\u2009=\u20091578 children) and 10 control schools (n\u2009=\u20091636 children', 'Wales, UK']","['KiVa', 'KiVa Bullying Prevention Program', 'waitlist control']","['Implementation fidelity', 'Lesson adherence', 'student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}]",3214.0,0.160181,There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes.,"[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Axford', 'Affiliation': 'NIHR ARC South West Peninsula (PenARC), University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Bjornstad', 'Affiliation': 'University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Clarkson', 'Affiliation': 'Bangor University, Bangor, UK.'}, {'ForeName': 'Obioha C', 'Initials': 'OC', 'LastName': 'Ukoumunne', 'Affiliation': 'PenARC, University of Exeter, Exeter, UK. o.c.ukoumunne@exeter.ac.uk.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Wrigley', 'Affiliation': 'University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': 'PenARC, University of Exeter, Exeter, UK.'}, {'ForeName': 'Vashti', 'Initials': 'V', 'LastName': 'Berry', 'Affiliation': 'PenARC, University of Exeter, Exeter, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hutchings', 'Affiliation': 'Bangor University, Bangor, UK.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01103-9'] 475,32231364,"An Integrative Adapt Therapy for common mental health symptoms and adaptive stress amongst Rohingya, Chin, and Kachin refugees living in Malaysia: A randomized controlled trial.","BACKGROUND This randomised controlled trial (RCT) aims to compare 6-week posttreatment outcomes of an Integrative Adapt Therapy (IAT) to a Cognitive Behavioural Therapy (CBT) on common mental health symptoms and adaptive capacity amongst refugees from Myanmar. IAT is grounded on psychotherapeutic elements specific to the refugee experience. METHODS AND FINDINGS We conducted a single-blind RCT (October 2017 -May 2019) with Chin (39.3%), Kachin (15.7%), and Rohingya (45%) refugees living in Kuala Lumpur, Malaysia. The trial included 170 participants receiving six 45-minute weekly sessions of IAT (97.6% retention, 4 lost to follow-up) and 161 receiving a multicomponent CBT also involving six 45-minute weekly sessions (96.8% retention, 5 lost to follow-up). Participants (mean age: 30.8 years, SD = 9.6) had experienced and/or witnessed an average 10.1 types (SD = 5.9, range = 1-27) of traumatic events. We applied a single-blind design in which independent assessors of pre- and posttreatment indices were masked in relation to participants' treatment allocation status. Primary outcomes were symptom scores of Post Traumatic Stress Disorder (PTSD), Complex PTSD (CPTSD), Major Depressive Disorder (MDD), the 5 scales of the Adaptive Stress Index (ASI), and a measure of resilience (the Connor-Davidson Resilience Scale [CDRS]). Compared to CBT, an intention-to-treat analysis (n = 331) at 6-week posttreatment follow-up demonstrated greater reductions in the IAT arm for all common mental disorder (CMD) symptoms and ASI domains except for ASI-3 (injustice), as well as increases in the resilience scores. Adjusted average treatment effects assessing the differences in posttreatment scores between IAT and CBT (with baseline scores as covariates) were -0.08 (95% CI: -0.14 to -0.02, p = 0.012) for PTSD, -0.07 (95% CI: -0.14 to -0.01) for CPTSD, -0.07 for MDD (95% CI: -0.13 to -0.01, p = 0.025), 0.16 for CDRS (95% CI: 0.06-0.026, p ≤ 0.001), -0.12 (95% CI: -0.20 to -0.03, p ≤ 0.001) for ASI-1 (safety/security), -0.10 for ASI-2 (traumatic losses; 95% CI: -0.18 to -0.02, p = 0.02), -0.03 for ASI-3 (injustice; (95% CI: -0.11 to 0.06, p = 0.513), -0.12 for ASI-4 (role/identity disruptions; 95% CI: -0.21 to -0.04, p ≤ 0.001), and -0.18 for ASI-5 (existential meaning; 95% CI: -0.19 to -0.05, p ≤ 0.001). Compared to CBT, the IAT group had larger effect sizes for all indices (except for resilience) including PTSD (IAT, d = 0.93 versus CBT, d = 0.87), CPTSD (d = 1.27 versus d = 1.02), MDD (d = 1.4 versus d = 1.11), ASI-1 (d = 1.1 versus d = 0.85), ASI-2 (d = 0.81 versus d = 0.66), ASI-3 (d = 0.49 versus d = 0.42), ASI-4 (d = 0.86 versus d = 0.67), and ASI-5 (d = 0.72 versus d = 0.53). No adverse events were recorded for either therapy. Limitations include a possible allegiance effect (the authors inadvertently conveying disproportionate enthusiasm for IAT in training and supervision), cross-over effects (counsellors applying elements of one therapy in delivering the other), and the brief period of follow-up. CONCLUSIONS Compared to CBT, IAT showed superiority in improving mental health symptoms and adaptative stress from baseline to 6-week posttreatment. The differences in scores between IAT and CBT were modest and future studies conducted by independent research teams need to confirm the findings. TRIAL REGISTRATION The study is registered under Australian New Zealand Clinical Trials Registry (ANZCTR) (http://www.anzctr.org.au/). The trial registration number is: ACTRN12617001452381.",2020,"Compared to CBT, the IAT group had larger effect sizes for all indices (except for resilience) including PTSD (IAT, d = 0.93 versus CBT, d = 0.87), CPTSD (","['170 participants receiving six 45-minute weekly sessions of IAT (97.6% retention, 4 lost to follow-up) and 161 receiving a', 'common mental health symptoms and adaptive stress amongst Rohingya, Chin, and Kachin refugees living in Malaysia', 'Participants (mean age: 30.8 years, SD = 9.6) had experienced and/or witnessed an average 10.1 types (SD = 5.9, range = 1-27) of traumatic events']","['Kachin', 'ASI-2', 'ASI-1', 'CBT, IAT', 'multicomponent CBT', 'Integrative Adapt Therapy (IAT', 'IAT', 'Cognitive Behavioural Therapy (CBT']","['ASI-2', 'ASI-1', 'mental health symptoms and adaptative stress', 'symptom scores of Post Traumatic Stress Disorder (PTSD), Complex PTSD (CPTSD), Major Depressive Disorder (MDD), the 5 scales of the Adaptive Stress Index (ASI), and a measure of resilience (the Connor-Davidson Resilience Scale [CDRS', 'MDD', 'adverse events']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0222045'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",170.0,0.276795,"Compared to CBT, the IAT group had larger effect sizes for all indices (except for resilience) including PTSD (IAT, d = 0.93 versus CBT, d = 0.87), CPTSD (","[{'ForeName': 'Alvin Kuowei', 'Initials': 'AK', 'LastName': 'Tay', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Hau Khat', 'Initials': 'HK', 'LastName': 'Mung', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Mohammad Abdul Awal', 'Initials': 'MAA', 'LastName': 'Miah', 'Affiliation': 'Perdana University-Centre for Research Excellence (PU-CRE), Selangor, Malaysia.'}, {'ForeName': 'Susheela', 'Initials': 'S', 'LastName': 'Balasundaram', 'Affiliation': 'Health Unit, United Nations High Commissioner for Refugees (UNHCR), Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section/ Division of Programme Support & Management, United Nations High Commissioner for Refugees (UNHCR), Geneva, Switzerland.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Badrudduza', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Sanjida', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Psychology, Jagannath University, Dhaka, Bangladesh.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'Perdana University-Royal College of Surgeons in Ireland (PU-RCSI) School of Medicine, Selangor, Malaysia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Mohsin', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Silove', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003073'] 476,31485014,Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial.,"OBJECTIVE To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). STUDY DESIGN We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). RESULT After the first interim analyses on 5% enrolment, the ""need for repeat dose(s) of surfactant"" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). CONCLUSIONS Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.",2019,"The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). ","['seven Indian centers between June 22, 2016 and January 11, 2018', 'preterm neonates', 'Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS', 'neonatal respiratory distress syndrome (RDS', 'preterm infants']","['GLSE or beractant', 'Goat lung surfactant', 'goat lung surfactant extract (GLSE', 'GLSE', 'beractant (Survanta®', 'bovine surfactant extract (beractant; Survanta®, AbbVie, USA']","['respiratory distress syndrome', 'death or BPD', 'composite of death or bronchopulmonary dysplasia (BPD']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0105750', 'cui_str': 'beractant'}, {'cui': 'C1510458', 'cui_str': 'Capras'}, {'cui': 'C0034085', 'cui_str': 'Pulmonary Surfactants'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0699934', 'cui_str': 'Survanta'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}]","[{'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}]",900.0,0.399564,"The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). ","[{'ForeName': 'Kajal', 'Initials': 'K', 'LastName': 'Jain', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Nangia', 'Affiliation': 'Lady Hardinge Medical College (LHMC), New Delhi, India.'}, {'ForeName': 'Vishnu Bhat', 'Initials': 'VB', 'LastName': 'Ballambattu', 'Affiliation': 'Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Venkataseshan', 'Initials': 'V', 'LastName': 'Sundaram', 'Affiliation': 'Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Ramji', 'Affiliation': 'Maulana Azad Medical College (MAMC), New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Thukral', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Yogendra Kumar', 'Initials': 'YK', 'LastName': 'Gupta', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Nishad', 'Initials': 'N', 'LastName': 'Plakkal', 'Affiliation': 'Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Mangalabharathi', 'Initials': 'M', 'LastName': 'Sundaram', 'Affiliation': 'Institute for Child Health (ICH), Chennai, India.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Jajoo', 'Affiliation': 'Chacha Nehru Bal Chikitsalaya (CNBC), New Delhi, India.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Kumutha', 'Initials': 'K', 'LastName': 'Jayaraman', 'Affiliation': 'Institute for Child Health (ICH), Chennai, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Maulana Azad Medical College (MAMC), New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Saili', 'Affiliation': 'Lady Hardinge Medical College (LHMC), New Delhi, India.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Murugesan', 'Affiliation': 'Institute for Child Health (ICH), Chennai, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Chawla', 'Affiliation': 'Government Medical College & Hospital, Chandigarh, India.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murki', 'Affiliation': 'Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Nanavati', 'Affiliation': 'King Edward Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': ""St. John's Medical College, Bangalore, India.""}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Vaidya', 'Affiliation': 'King Edward Memorial Hospital, Pune, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Arpan Newborn Care center and Sterling NICU, Ahmedabad, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Arora', 'Affiliation': 'Dayanand Medical College and Hospital, Punjab, India.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Mondkar', 'Affiliation': 'Lokmanya Tilak Municipal General Hospital (SION Hospital), Mumbai, India.'}, {'ForeName': 'Sugandha', 'Initials': 'S', 'LastName': 'Arya', 'Affiliation': 'Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Bahl', 'Affiliation': 'Clinical Development Services Agency, Faridabad, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Utture', 'Affiliation': 'King Edward Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Manerkar', 'Affiliation': 'Lokmanya Tilak Municipal General Hospital (SION Hospital), Mumbai, India.'}, {'ForeName': 'Swarna Rekha', 'Initials': 'SR', 'LastName': 'Bhat', 'Affiliation': ""St. John's Medical College, Bangalore, India.""}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Parikh', 'Affiliation': 'King Edward Memorial Hospital, Pune, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Arpan Newborn Care center and Sterling NICU, Ahmedabad, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Bajpai', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Sivanandan', 'Affiliation': 'Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Pawandeep Kaur', 'Initials': 'PK', 'LastName': 'Dhawan', 'Affiliation': 'Clinical Development Services Agency, Faridabad, India.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Vishwakarma', 'Affiliation': 'Clinical Development Services Agency, Faridabad, India.'}, {'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Bangera', 'Affiliation': 'Clinical Development Services Agency, Faridabad, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Clinical Development Services Agency, Faridabad, India.'}, {'ForeName': 'Shridhar', 'Initials': 'S', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Command Hospital, Panchkula, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Raipur, India.'}, {'ForeName': 'Chandra Kumar', 'Initials': 'CK', 'LastName': 'Natarajan', 'Affiliation': 'Cloudnine Hospital, Chennai, India.'}, {'ForeName': 'Anumeet', 'Initials': 'A', 'LastName': 'Saini', 'Affiliation': 'Lady Hardinge Medical College (LHMC), New Delhi, India.'}, {'ForeName': 'Sukanya', 'Initials': 'S', 'LastName': 'Karunanidhi', 'Affiliation': 'Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Malik', 'Affiliation': 'Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Narang', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Gurkirat', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Maulana Azad Medical College (MAMC), New Delhi, India.'}, {'ForeName': 'Chander Prakash', 'Initials': 'CP', 'LastName': 'Yadav', 'Affiliation': 'National Institute of Malaria Research, New Delhi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Deorari', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India. ra.aiims@gmail.com.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0472-0'] 477,32014119,"Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis (New EPOC): long-term results of a multicentre, randomised, controlled, phase 3 trial.","BACKGROUND The interim analysis of the multicentre New EPOC trial in patients with resectable colorectal liver metastasis showed a significant reduction in progression-free survival in patients allocated to cetuximab plus chemotherapy compared with those given chemotherapy alone. The focus of the present analysis was to assess the effect on overall survival. METHODS New EPOC was a multicentre, open-label, randomised, controlled, phase 3 trial. Adult patients (aged ≥18 years) with KRAS wild-type (codons 12, 13, and 61) resectable or suboptimally resectable colorectal liver metastases and a WHO performance status of 0-2 were randomly assigned (1:1) to receive chemotherapy with or without cetuximab before and after liver resection. Randomisation was done centrally with minimisation factors of surgical centre, poor prognosis cancer, and previous adjuvant treatment with oxaliplatin. Chemotherapy consisted of oxaliplatin 85 mg/m 2 administered intravenously over 2 h, l-folinic acid (175 mg flat dose administered intravenously over 2 h) or d,l-folinic acid (350 mg flat dose administered intravenously over 2 h), and fluorouracil bolus 400 mg/m 2 administered intravenously over 5 min, followed by a 46 h infusion of fluorouracil 2400 mg/m 2 repeated every 2 weeks (regimen one), or oxaliplatin 130 mg/m 2 administered intravenously over 2 h and oral capecitabine 1000 mg/m 2 twice daily on days 1-14 repeated every 3 weeks (regimen two). Patients who had received adjuvant oxaliplatin could receive irinotecan 180 mg/m 2 intravenously over 30 min with fluorouracil instead of oxaliplatin (regimen three). Cetuximab was given intravenously, 500 mg/m 2 every 2 weeks with regimen one and three or a loading dose of 400 mg/m 2 followed by a weekly infusion of 250 mg/m 2 with regimen two. The primary endpoint of progression-free survival was published previously. Secondary endpoints were overall survival, preoperative response, pathological resection status, and safety. Trial recruitment was halted prematurely on the advice of the Trial Steering Committee on Nov 1, 2012. All analyses (except safety) were done on the intention-to-treat population. Safety analyses included all randomly assigned patients. This trial is registered with ISRCTN, number 22944367. FINDINGS Between Feb 26, 2007, and Oct 12, 2012, 257 eligible patients were randomly assigned to chemotherapy with cetuximab (n=129) or without cetuximab (n=128). This analysis was carried out 5 years after the last patient was recruited, as defined in the protocol, at a median follow-up of 66·7 months (IQR 58·0-77·5). Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304). Median overall survival was 81·0 months (59·6 to not reached) in the chemotherapy alone group and 55·4 months (43·5-71·5) in the chemotherapy plus cetuximab group (HR 1·45, 1·02-2·05; p=0·036). There was no significant difference in the secondary outcomes of preoperative response or pathological resection status between groups. Five deaths might have been treatment-related (one in the chemotherapy alone group and four in the chemotherapy plus cetuximab group). The most common grade 3-4 adverse events reported were: neutrophil count decreased (26 [19%] of 134 in the chemotherapy alone group vs 21 [15%] of 137 in the chemotherapy plus cetuximab group), diarrhoea (13 [10%] vs 14 [10%]), skin rash (one [1%] vs 22 [16%]), thromboembolic events (ten [7%] vs 11 [8%]), lethargy (ten [7%] vs nine [7%]), oral mucositis (three [2%] vs 14 [10%]), vomiting (seven [5%] vs seven [5%]), peripheral neuropathy (eight [6%] vs five [4%]), and pain (six [4%] vs six [4%]). INTERPRETATION Although the addition of cetuximab to chemotherapy improves the overall survival in some studies in patients with advanced, inoperable metastatic disease, its use in the perioperative setting in patients with operable disease confers a significant disadvantage in terms of overall survival. Cetuximab should not be used in this setting. FUNDING Cancer Research UK.",2020,"Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304).","['Between Feb 26, 2007, and Oct 12, 2012', 'Adult patients (aged ≥18 years) with KRAS wild-type (codons 12, 13, and 61) resectable or suboptimally resectable colorectal liver metastases and a WHO performance status of 0-2', 'patients with resectable colorectal liver metastasis (New EPOC', 'patients with advanced, inoperable metastatic disease', 'patients with resectable colorectal liver metastasis', '257 eligible patients']","['adjuvant oxaliplatin', 'Cetuximab', 'l-folinic acid', 'irinotecan 180 mg/m 2 intravenously over 30 min with fluorouracil instead of oxaliplatin', 'cetuximab to chemotherapy', 'oxaliplatin 130 mg/m 2 administered intravenously over 2 h and oral capecitabine', 'cetuximab plus chemotherapy', 'Systemic chemotherapy with or without cetuximab', 'fluorouracil', 'oxaliplatin 85 mg/m 2 administered intravenously over 2 h, l-folinic acid', 'chemotherapy with or without cetuximab', 'chemotherapy with cetuximab (n=129) or without cetuximab', 'oxaliplatin']","['diarrhoea', 'thromboembolic events', 'Median progression-free survival', 'peripheral neuropathy', 'lethargy', 'Median overall survival', 'vomiting', 'pain', 'neutrophil count', 'preoperative response or pathological resection status', 'progression-free survival', 'skin rash', 'overall survival', 'overall survival, preoperative response, pathological resection status, and safety', 'oral mucositis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009221', 'cui_str': 'Codon'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}]",257.0,0.335991,"Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, University College London, London, UK. Electronic address: j.bridgewater@ucl.ac.uk.'}, {'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'Pugh', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zina', 'Initials': 'Z', 'LastName': 'Eminton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Mellor', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Whitehead', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Radford', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corkhill', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Gareth O', 'Initials': 'GO', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences/The Christie NHS Foundation Trust, University of Manchester, Manchester, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Ajith K', 'Initials': 'AK', 'LastName': 'Siriwardena', 'Affiliation': 'Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hornbuckle', 'Affiliation': 'Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Myrddin', 'Initials': 'M', 'LastName': 'Rees', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Iveson', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Dorset Cancer Centre/Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'O James', 'Initials': 'OJ', 'LastName': 'Garden', 'Affiliation': 'Clinical Surgery, University of Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Maughan', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Primrose', 'Affiliation': 'Department of Surgery, University of Southampton, Southampton, UK. Electronic address: j.n.primrose@soton.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30798-3'] 478,32203696,"Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial.","BACKGROUND BIG 3-07/TROG 07.01 is an international, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofractionation in patients with non-low-risk ductal carcinoma in situ following breast-conserving surgery and whole breast radiotherapy. Here, we report the effects of diagnosis and treatment on health-related quality of life (HRQOL) at 2 years. METHODS The BIG 3-07/TROG 07.01 trial is ongoing at 118 hospitals in 11 countries. Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ were randomly assigned, by use of a minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy using one of three randomisation categories. Category A was a 4-arm randomisation of tumour bed boost versus no boost following conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy (42·5 Gy in 16 fractions over 3·5 weeks). Category B was a 2-arm randomisation between tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy. Stratification factors were age at diagnosis, planned endocrine therapy, and treating centre. The primary endpoint, time to local recurrence, will be reported when participants have completed 5 years of follow-up. The HRQOL statistical analysis plan prespecified eight aspects of HRQOL, assessed by four questionnaires at baseline, end of treatment, and at 6, 12, and 24 months after radiotherapy: fatigue and physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question). For each of these measures, tumour bed boost was compared with no boost, and conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy, by use of generalised estimating equation models. Analyses were by intention to treat, with Hochberg adjustment for multiple testing. This trial is registered with ClinicalTrials.gov, NCT00470236. FINDINGS Between June 1, 2007, and Aug 14, 2013, 1208 women were enrolled and randomly assigned to receive no tumour bed boost (n=605) or tumour bed boost (n=603). 396 of 1208 women were assigned to category A: conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost (n=100). 447 were assigned to category B: conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost (n=224). 365 were assigned to category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost (n=183). All patients were followed up at 2 years for the HRQOL analysis. 1098 (91%) of 1208 patients received their allocated treatment, and most completed their scheduled HRQOL assessments (1147 [95%] of 1208 at baseline; 988 [87%] of 1141 at 2 years). Cosmetic status was worse with tumour bed boost than with no boost across all timepoints (difference 0·10 [95% CI 0·05-0·15], global p=0·00014, Hochberg-adjusted p=0·0016); at the end of treatment, the estimated difference between tumour bed boost and no boost was 0·13 (95% CI 0·06-0·20; p=0·00021), persisting at 24 months (0·13 [0·06-0·20]; p=0·00021). Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08 [95% CI 0·03-0·13], global p=0·0033, Hochberg adjusted p=0·045); the difference between tumour bed boost and no boost at the end of treatment was 0·08 (0·01 to 0·15, p=0·021), and did not persist at 24 months (0·04 [-0·03 to 0·11], p=0·29). None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. Conventional whole breast radiotherapy was associated with worse body image than hypofractionated whole breast radiotherapy at the end of treatment (difference -1·10 [95% CI -1·79 to -0·42], p=0·0016). No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy. INTERPRETATION Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending. FUNDING National Health and Medical Research Council, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society.",2020,Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08,"['Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ', 'non-low-risk ductal carcinoma', '396 of 1208 women were assigned to category A', '118 hospitals in 11 countries', 'patients with non-low-risk ductal carcinoma', '1098 (91%) of 1208 patients', 'Between June 1, 2007, and Aug 14, 2013, 1208 women']","['minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy', 'conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost', 'conventional whole breast radiotherapy', 'conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost', 'category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost', 'Conventional whole breast radiotherapy', 'tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy', 'no tumour bed boost (n=605) or tumour bed boost', 'breast-conserving surgery and whole breast radiotherapy', 'conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy', 'breast-conserving therapy and adjuvant radiotherapy']","['physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question', 'Cosmetic status', 'HRQOL', 'health-related quality of life (HRQOL', 'shoulder function', 'time to local recurrence', 'Quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002045'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0085415'}, {'cui': 'C0222045'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0036915', 'cui_str': 'Sexuality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",1208.0,0.212892,Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08,"[{'ForeName': 'Madeleine T', 'Initials': 'MT', 'LastName': 'King', 'Affiliation': 'Faculty of Science, School of Psychology, The University of Sydney, Sydney, NSW, Australia. Electronic address: madeleine.king@sydney.edu.au.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Link', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ivo A', 'Initials': 'IA', 'LastName': 'Olivotto', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kunkler', 'Affiliation': 'Edinburgh Cancer Research Centre, Institute of Genetic and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Antonia Helen', 'Initials': 'AH', 'LastName': 'Westenberg', 'Affiliation': 'Radiotherapiegroep Arnhem, Arnhem, The Netherlands.'}, {'ForeName': 'Guenther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Institute for Radiotherapy, Klinik Hirslanden, Zurich, Switzerland.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Behavioural Sciences Unit, Department of Cancer Experiences Research, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia; Department of Psychology, and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, VIC, Australia.'}, {'ForeName': 'Boon H', 'Initials': 'BH', 'LastName': 'Chua', 'Affiliation': 'University of New South Wales, UNSW Medicine, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30085-1'] 479,32217739,Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial.,"BACKGROUND Approximately 25% of children with concussion have persistent postconcussive symptoms (PPCS) with resultant significant impacts on quality of life. Melatonin has significant neuroprotective properties, and promising preclinical data suggest its potential to improve outcomes after traumatic brain injury. We hypothesized that treatment with melatonin would result in a greater decrease in PPCS symptoms when compared with a placebo. METHODS We conducted a randomized, double-blind trial of 3 or 10 mg of melatonin compared with a placebo (NCT01874847). We included youth (ages 8-18 years) with PPCS at 4 to 6 weeks after mild traumatic brain injury. Those with significant medical or psychiatric histories or a previous concussion within the last 3 months were excluded. The primary outcome was change in the total youth self-reported Post-Concussion Symptom Inventory score measured after 28 days of treatment. Secondary outcomes included change in health-related quality of life, cognition, and sleep. RESULTS Ninety-nine children (mean age: 13.8 years; SD = 2.6 years; 58% girls) were randomly assigned. Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21 (95% confidence interval [CI]: -16 to -27). There was no significant effect of melatonin when compared with a placebo in the intention-to-treat analysis (3 mg melatonin, -2 [95% CI: -13 to 6]; 10 mg melatonin, 4 [95% CI: -7 to 14]). No significant group differences in secondary outcomes were observed. Side effects were mild and similar to the placebo. CONCLUSIONS Children with PPCS had significant impairment in their quality of life. Seventy-eight percent demonstrated significant recovery between 1 and 3 months postinjury. This clinical trial does not support the use of melatonin for the treatment of pediatric PPCS.",2020,Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21,"['Ninety-nine children (mean age: 13.8 years; SD = 2.6 years; 58% girls', 'Children With Postconcussive Symptoms', 'We included youth (ages 8-18 years) with PPCS at 4 to 6 weeks after mild traumatic brain injury']","['melatonin', 'placebo', 'Melatonin']","['total youth self-reported Post-Concussion Symptom Inventory score', 'Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21', 'PPCS symptoms', 'quality of life', 'change in health-related quality of life, cognition, and sleep', 'Side effects']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",99.0,0.792017,Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21,"[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Barlow', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and kbarlow@uq.edu.au.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Brooks', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Esser', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kirton', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Mikrogianakis', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Zemek', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine and Research Institute, Children's Hospital of Eastern Ontario and University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'MacMaster', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Keith Owen', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Kirk', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hutchison', 'Affiliation': 'Neurosciences and Mental Health Research Program, Department of Critical Care Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': ""Neuroscience Program, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Turley', 'Affiliation': ""Neuroscience Program, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Cameron', 'Affiliation': 'Research Pharmacy, Foothills Medical Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Clinical Neurosciences, Cumming School of Medicine and.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Samuel', 'Affiliation': ""Neuroscience Program, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Buchhalter', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Richer', 'Affiliation': ""Department of Pediatrics and Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Platt', 'Affiliation': 'McGill University, Montreal, Québec, Canada; and.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Boyd', 'Affiliation': 'Child Health Research Centre, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Dewey', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}]",Pediatrics,['10.1542/peds.2019-2812'] 480,32035020,"Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial.","BACKGROUND Capivasertib (AZD5363) is a potent selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT. The FAKTION trial investigated whether the addition of capivasertib to fulvestrant improved progression-free survival in patients with aromatase inhibitor-resistant advanced breast cancer. METHODS In this randomised, double-blind, placebo-controlled, phase 2 trial, postmenopausal women aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-2 and oestrogen receptor-positive, HER2-negative, metastatic or locally advanced inoperable breast cancer who had relapsed or progressed on an aromatase inhibitor were recruited from 19 hospitals in the UK. Enrolled participants were randomly assigned (1:1) to receive intramuscular fulvestrant 500 mg (day 1) every 28 days (plus a loading dose on day 15 of cycle 1) with either capivasertib 400 mg or matching placebo, orally twice daily on an intermittent weekly schedule of 4 days on and 3 days off (starting on cycle 1 day 15) until disease progression, unacceptable toxicity, loss to follow-up, or withdrawal of consent. Treatment allocation was done using an interactive web-response system using a minimisation method (with a 20% random element) and the following minimisation factors: measurable or non-measurable disease, primary or secondary aromatase inhibitor resistance, PIK3CA status, and PTEN status. The primary endpoint was progression-free survival with a one-sided alpha of 0·20. Analyses were done by intention to treat. Recruitment is complete, and the trial is in follow-up. This trial is registered with ClinicalTrials.gov, number NCT01992952. FINDINGS Between March 16, 2015, and March 6, 2018, 183 patients were screened for eligibility, of whom 140 (76%) were eligible and were randomly assigned to receive fulvestrant plus capivasertib (n=69) or fulvestrant plus placebo (n=71). Median follow-up for progression-free survival was 4·9 months (IQR 1·6-11·6). At the time of primary analysis for progression-free survival (Jan 30, 2019), 112 progression-free survival events had occurred, 49 (71%) in 69 patients in the capivasertib group compared with 63 (89%) of 71 in the placebo group. Median progression-free survival was 10·3 months (95% CI 5·0-13·2) in the capivasertib group versus 4·8 months (3·1-7·7) in the placebo group, giving an unadjusted hazard ratio (HR) of 0·58 (95% CI 0·39-0·84) in favour of the capivasertib group (two-sided p=0·0044; one-sided log rank test p=0·0018). The most common grade 3-4 adverse events were hypertension (22 [32%] of 69 patients in the capivasertib group vs 17 [24%] of 71 in the placebo group), diarrhoea (ten [14%] vs three [4%]), rash (14 [20%] vs 0), infection (four [6%] vs two [3%]), and fatigue (one [1%] vs three [4%]). Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one). One death, due to atypical pulmonary infection, was assessed as possibly related to capivasertib treatment. One further death in the capivasertib group had an unknown cause; all remaining deaths in both groups (19 in the capivasertib group and 31 in the placebo group) were disease related. INTERPRETATION Progression-free survival was significantly longer in participants who received capivasertib than in those who received placebo. The combination of capivasertib and fulvestrant warrants further investigation in phase 3 trials. FUNDING AstraZeneca and Cancer Research UK.",2020,"Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one).","['Between March 16, 2015, and March 6, 2018, 183 patients were screened for eligibility, of whom 140 (76%) were eligible', 'postmenopausal women aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-2 and oestrogen receptor-positive, HER2-negative, metastatic or locally advanced inoperable breast cancer who had relapsed or progressed on an aromatase inhibitor were recruited from 19 hospitals in the UK', 'patients with aromatase inhibitor-resistant advanced breast cancer']","['Fulvestrant plus capivasertib versus placebo', 'capivasertib to fulvestrant', 'capivasertib 400 mg or matching placebo', 'capivasertib and fulvestrant', 'fulvestrant plus capivasertib (n=69) or fulvestrant plus placebo', 'Capivasertib (AZD5363', 'placebo', 'intramuscular fulvestrant']","['diarrhoea', '112 progression-free survival events', 'Median progression-free survival', 'acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting', 'Progression-free survival', 'rash', 'Serious adverse reactions', 'fatigue', 'infection', 'progression-free survival', 'Median follow-up for progression-free survival']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3502775', 'cui_str': 'AZD5363'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0041657', 'cui_str': 'Unconscious State'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",183.0,0.690338,"Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one).","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Jones', 'Affiliation': 'Department of Cancer and Genetics, Cardiff University, Cardiff, UK; Velindre Cancer Centre, Cardiff, UK. Electronic address: robert.hugh.jones@wales.nhs.uk.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Casbard', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Carucci', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'All Wales Laboratory Genetics Service, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Alchami', 'Affiliation': 'Department of Cellular Pathology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Tracie-Ann', 'Initials': 'TA', 'LastName': 'Madden', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bale', 'Affiliation': 'Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Bezecny', 'Affiliation': 'Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Joffe', 'Affiliation': 'Calderdale & Huddersfield NHS Foundation Trust, Huddersfield, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': 'University of Leeds and Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Venkitaraman', 'Affiliation': 'The Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Waters', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sacha J', 'Initials': 'SJ', 'LastName': 'Howell', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30817-4'] 481,32243885,A High-Definition tDCS and EEG study on attention and vigilance: Brain stimulation mitigates the executive but not the arousal vigilance decrement.,"Attention comprises a wide set of processes such as phasic alertness, orienting, executive control, and the executive (i.e., detecting infrequent targets) and arousal (i.e., sustaining a fast reaction) vigilance components. Importantly, the effects of transcranial direct current stimulation (tDCS) over attentional functioning have been mostly addressed by measuring these processes separately and by delivering offline tDCS with low precision over the stimulation region. In the current study, we examined the effects of online High-Definition tDCS (HD-tDCS) over the behavioral and electrophysiological functioning of attentional and vigilance components. Participants (N = 92) were randomly assigned to one of three stimulation groups: right dorsolateral prefrontal cortex stimulation, right posterior parietal cortex (PPC) stimulation, and sham. All of them performed - in combination with the HD-tDCS protocol - an attentional networks task (ANTI-Vea) suitable to measure the executive and arousal components of vigilance along with three typical attentional functions: phasic alertness, orienting, and executive control. In addition, EEG was registered at the baseline and at the post-stimulation period. We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task. Interestingly, only HD-tDCS over PPC reduced considerably the increment of alpha power observed across time-on-task (p = .009). The current study provides further evidence for both an empirical dissociation between vigilance components and the cortical regions underlying attentional processes. We highlight the advantages of using online HD-tDCS to examine the stimulation effects on attentional and vigilance functioning.",2020,"We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task.",['Participants (N\u202f=\u202f92'],"['right dorsolateral prefrontal cortex stimulation, right posterior parietal cortex (PPC) stimulation, and sham', 'transcranial direct current stimulation (tDCS', 'online High-Definition tDCS (HD-tDCS']","['arousal vigilance', 'attention and vigilance', 'attentional and vigilance functioning', 'executive vigilance decrement', 'phasic alertness']",[],"[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456855', 'cui_str': 'Right posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",92.0,0.0261973,"We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task.","[{'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Instituto de Investigaciones Psicológicas (IIPsi), CONICET-UNC. Facultad de Psicología, Universidad Nacional de Córdoba, Boulevard de la Reforma esquina Enfermera Gordillo, CP, 5000, Córdoba, Argentina(1); Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: fluna@unc.edu.ar.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Román-Caballero', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: rrarroca@ugr.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Barttfeld', 'Affiliation': 'Instituto de Investigaciones Psicológicas (IIPsi), CONICET-UNC. Facultad de Psicología, Universidad Nacional de Córdoba, Boulevard de la Reforma esquina Enfermera Gordillo, CP, 5000, Córdoba, Argentina(1). Electronic address: pablob@conicet.gov.ar.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: jlupiane@ugr.es.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Martín-Arévalo', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: emartina@ugr.es.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107447'] 482,32245569,"Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial.","BACKGROUND This study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS In a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary centre were randomised to receive sildenafil citrate 12.5 mg kg -1 i.v. over 150 min or dextrose 5% at the commencement of surgery. The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals. RESULTS The analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 μmol L -1 [-5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups. CONCLUSIONS These results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery. CLINICAL TRIAL REGISTRATION ISRCTN18386427.",2020,"There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044).","['60 subjects in the sildenafil group and 69 in the placebo control group', 'acute kidney injury undergoing cardiac surgery in a single UK tertiary centre', 'at-risk patients undergoing cardiac surgery with cardiopulmonary bypass', 'and post-cardiac surgery acute kidney injury']","['dextrose', 'placebo', 'valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass', 'Intravenous sildenafil citrate', 'sildenafil citrate', 'sildenafil']","['serum creatinine', 'clinical events and potential disease mechanisms', 'acute kidney injury', 'creatinine concentration', 'biomarkers of kidney injury, endothelial function, and inflammatory cell activation', 'glomerular filtration rate, and surgical procedure', 'multiple organ dysfunction scores']","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1960439', 'cui_str': 'Multiple organ dysfunction score'}]",,0.802905,"There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Hardeep', 'Initials': 'H', 'LastName': 'Aujla', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Woźniak', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Dott', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Nikol', 'Initials': 'N', 'LastName': 'Sullo', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Lathishia', 'Initials': 'L', 'LastName': 'Joel-David', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Smallwood', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; School of Allied Health Sciences, De Montfort University, Leicester, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Eagle-Hemming', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Ana Suazo', 'Initials': 'AS', 'LastName': 'Di Paola', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Brunskill', 'Affiliation': 'Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; Leicester Clinical Trials Unit, University of Leicester, Leicester, UK. Electronic address: gjm19@le.ac.uk.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.01.030'] 483,32030526,Few Aggressive or Violent Incidents are Associated with the Use of HIV Self-tests to Screen Sexual Partners Among Key Populations.,"Men who have sex with men and transgender women who had multiple sexual partners in the prior 3 months participated in ISUM, a randomized, controlled trial of self- and partner-testing in New York City and San Juan, PR. Only 2% of screened participants were ineligible to enroll due to anticipating they would find it very hard to avoid or handle violence. The intervention group received free rapid HIV self-test kits. During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner. Only 6% of participants who asked a partner in person to test reported that at least one of their partners got physically violent, some in the context of sex work. In total, 16 (2%) partners reacted violently. Post-trial, only one participant reported finding it very hard to handle violence, and none found it very hard to avoid potential violence.",2020,"During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner.",['Men who have sex with men and transgender women who had multiple sexual partners in the prior 3\xa0months participated in'],"['ISUM', 'free rapid HIV self-test kits', 'self- and partner-testing in New York City and San Juan, PR']",[],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0558265', 'cui_str': 'Multiple sexual contacts (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]",[],114.0,0.0231364,"During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. rebecca.giguere@nyspi.columbia.edu.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rael', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02809-1'] 484,32209700,Dietary Fats and Atherosclerosis From Childhood to Adulthood.,"BACKGROUND The association of dietary fat distribution with markers of subclinical atherosclerosis during early life is unknown. We examined whether success in achieving the main target of an infancy-onset dietary intervention based on the distribution of dietary fat was associated with aortic and carotid intima-media thickness (IMT) and distensibility from childhood to young adulthood. METHODS In the prospective randomized controlled Special Turku Coronary Risk Factor Intervention Project trial, personalized dietary counseling was given biannually to healthy children from infancy to young adulthood. The counseling was based on Nordic Nutrition Recommendations, with the main aim of improving the distribution of dietary fat in children's diets. IMT and distensibility of the abdominal aorta and common carotid artery were measured repeatedly at ages 11 ( n = 439), 13 ( n = 499), 15 ( n = 506), 17 ( n = 477), and 19 years ( n = 429). The targeted distribution of dietary fat was defined as a ratio of saturated fatty acids to monounsaturated and polyunsaturated fatty acids of <1:2 and as an intake of saturated fatty acids of <10% of energy intake. Participants who met ≥1 of these 2 criteria were defined to achieve the main intervention target. RESULTS Individuals who achieved the main intervention target had lower aortic IMT (age- and sex-adjusted mean difference 10.4 µm; 95% confidence interval: 0.3 to 20.5 µm) and better aortic distensibility (0.13% per 10 mm Hg; 95% confidence interval: 0.00% to 0.26% per10 mm Hg) compared with their peers who did not meet the target. CONCLUSIONS Achieving the main target of an infancy-onset dietary intervention, reflecting dietary guidelines, was favorably associated with aortic IMT and distensibility during the early life course. These data support the recommendation of favoring unsaturated fat to enhance arterial health.",2020,"RESULTS Individuals who achieved the main intervention target had lower aortic IMT (age- and sex-adjusted mean difference 10.4 µm; 95% confidence interval: 0.3 to 20.5 µm) and better aortic distensibility (0.13% per 10 mm Hg; 95% confidence interval: 0.00% to 0.26% per10 mm Hg) compared with their peers who did not meet the target. ","['Participants who met ≥1 of these 2 criteria were defined to achieve the main intervention target', 'healthy children from infancy to young adulthood', 'ages 11 ( n = 439), 13 ( n = 499), 15 ( n = 506), 17 ( n = 477), and 19 years ( n = 429', ""children's diets""]",['personalized dietary counseling'],"['lower aortic IMT', 'IMT and distensibility of the abdominal aorta and common carotid artery', 'aortic distensibility', 'aortic IMT and distensibility']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0003484', 'cui_str': 'Aorta, Abdominal'}, {'cui': 'C0162859', 'cui_str': 'Common carotid artery structure'}]",,0.0710509,"RESULTS Individuals who achieved the main intervention target had lower aortic IMT (age- and sex-adjusted mean difference 10.4 µm; 95% confidence interval: 0.3 to 20.5 µm) and better aortic distensibility (0.13% per 10 mm Hg; 95% confidence interval: 0.00% to 0.26% per10 mm Hg) compared with their peers who did not meet the target. ","[{'ForeName': 'Tomi T', 'Initials': 'TT', 'LastName': 'Laitinen', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and tomi.laitinen@utu.fi.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Nuotio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Suvi P', 'Initials': 'SP', 'LastName': 'Rovio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Departments of Pediatrics and Adolescent Medicine.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Juonala', 'Affiliation': 'Medicine, and.'}, {'ForeName': 'Costan G', 'Initials': 'CG', 'LastName': 'Magnussen', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': 'Department of Pediatric Cardiology, University of Helsinki and Hospital for Children and Adolescents, Helsinki, Finland; and.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Public Health, University of Turku, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'Department of Chronic Disease Prevention, Institute for Health and Welfare, Turku, Finland.'}, {'ForeName': 'Jorma S A', 'Initials': 'JSA', 'LastName': 'Viikari', 'Affiliation': 'Medicine, and.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Medicine, and.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}]",Pediatrics,['10.1542/peds.2019-2786'] 485,32164906,"Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND The triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab showed improved outcomes for patients with metastatic colorectal cancer, compared with FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab. However, the actual benefit of the upfront exposure to the three cytotoxic drugs compared with a preplanned sequential strategy of doublets was not clear, and neither was the feasibility or efficacy of therapies after disease progression. We aimed to compare a preplanned strategy of upfront FOLFOXIRI followed by the reintroduction of the same regimen after disease progression versus a sequence of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) and FOLFIRI doublets, in combination with bevacizumab. METHODS TRIBE2 was an open-label, phase 3, randomised study of patients aged 18-75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units. Patients were stratified according to centre, ECOG performance status, primary tumour location, and previous adjuvant chemotherapy. A randomisation system incorporating a minimisation algorithm was used to randomly assign patients (1:1) via a masked web-based allocation procedure to two different treatment strategies. In the control group, patients received first-line mFOLFOX6 (85 mg/m 2 of intravenous oxaliplatin concurrently with 200 mg/m 2 of leucovorin over 120 min; 400 mg/m 2 intravenous bolus of fluorouracil; 2400 mg/m 2 continuous infusion of fluorouracil for 48 h) plus bevacizumab (5 mg/kg intravenously over 30 min) followed by FOLFIRI (180 mg/m 2 of intravenous irinotecan over 120 min concurrently with 200 mg/m 2 of leucovorin; 400 mg/m 2 intravenous bolus of fluorouracil; 2400 mg/m 2 continuous infusion of fluorouracil for 48 h) plus bevacizumab after disease progression. In the experimental group, patients received FOLFOXIRI (165 mg/m 2 of intravenous irinotecan over 60 min; 85 mg/m 2 intravenous oxaliplatin concurrently with 200 mg/m 2 of leucovorin over 120 min; 3200 mg/m 2 continuous infusion of fluorouracil for 48 h) plus bevacizumab followed by the reintroduction of the same regimen after disease progression. Combination treatments were repeated every 14 days for up to eight cycles followed by fluorouracil and leucovorin (at the same dose administered at the last induction cycle) plus bevacizumab maintenance until disease progression, unacceptable adverse events, or consent withdrawal. Patients and investigators were not masked. The primary endpoint was progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat. Safety was assessed in patients who received at least one dose of their assigned treatment. Study recruitment is complete and follow-up is ongoing. This trial is registered with Clinicaltrials.gov, NCT02339116. FINDINGS Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group). At data cut-off (July 30, 2019) median follow-up was 35·9 months (IQR 30·1-41·4). Median progression-free survival 2 was 19·2 months (95% CI 17·3-21·4) in the experimental group and 16·4 months (15·1-17·5) in the control group (hazard ratio [HR] 0·74, 95% CI 0·63-0·88; p=0·0005). During the first-line treatment, the most frequent of all-cause grade 3-4 events were diarrhoea (57 [17%] vs 18 [5%]), neutropenia (168 [50%] vs 71 [21%]), and arterial hypertension (25 [7%] vs 35 [10%]) in the experimental group compared with the control group. Serious adverse events occurred in 84 (25%) patients in the experimental group and in 56 (17%) patients in the control group. Eight treatment-related deaths were reported in the experimental group (two intestinal occlusions, two intestinal perforations, two sepsis, one myocardial infarction, and one bleeding) and four in the control group (two occlusions, one perforation, and one pulmonary embolism). After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients). Serious adverse events after disease progression occurred in 20 (15%) patients in the experimental group and 25 (12%) in the control group. Three treatment-related deaths after first disease progression were reported in the experimental group (two intestinal occlusions and one sepsis) and four in the control group (one intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis). INTERPRETATION Upfront FOLFOXIRI plus bevacizumab followed by the reintroduction of the same regimen after disease progression seems to be a preferable therapeutic strategy to sequential administration of chemotherapy doublets, in combination with bevacizumab, for patients with metastatic colorectal cancer selected according to the study criteria. FUNDING The GONO Cooperative Group, the ARCO Foundation, and F Hoffmann-La Roche.",2020,"After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients).","['patients aged 18-75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units', 'Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group', 'patients with metastatic colorectal cancer selected according to the study criteria', 'patients with metastatic colorectal cancer (TRIBE2', 'patients with metastatic colorectal cancer']","['first-line mFOLFOX6', 'FOLFOXIRI', 'intravenous irinotecan', 'fluorouracil and leucovorin', 'Upfront FOLFOXIRI plus bevacizumab', 'FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab', 'leucovorin', 'fluorouracil', 'FOLFIRI (180 mg/m 2 of intravenous irinotecan', 'mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin', 'fluorouracil; 2400 mg/m 2 continuous infusion of fluorouracil', 'bevacizumab', 'FOLFIRI plus bevacizumab', 'mFOLFOX6 plus bevacizumab', 'triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab', 'oxaliplatin']","['Median progression-free survival', 'intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis', 'intestinal perforations, two sepsis, one myocardial infarction, and one bleeding', 'diarrhoea', 'progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat', 'Serious adverse events', 'incidence of grade 3 or 4 adverse events', 'neutropenia', 'neurotoxicity', 'Safety', 'Serious adverse events after disease progression', 'arterial hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4553808', 'cui_str': 'Intestinal occlusion'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0580351', 'cui_str': 'Treatment given'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",679.0,0.0771876,"After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy; Oncology and Hemato-oncology Department, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bordonaro', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy.'}, {'ForeName': 'Tiziana Pia', 'Initials': 'TP', 'LastName': 'Latiano', 'Affiliation': 'Oncology Unit, Foundation IRCCS, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Oncology Unit, Ospedale degli Infermi, Rimini, Italy; Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City Hospital, Tricase, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Marmorino', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Grande', 'Affiliation': 'Department of Medical Oncology, F Spaziani Hospital, Lazio, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Aprile', 'Affiliation': 'Department of Oncology, University and General Hospital, Udine, Italy; Department of Oncology, San Bortolo General Hospital, Vicenza, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Poliambulanza Foundation, Brescia, Italy.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Murgioni', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Granetto', 'Affiliation': 'Department of Oncology, S Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buonadonna', 'Affiliation': 'Department of Medical Oncology, IRCCS, Centro di Riferimento Oncologico National Cancer Institute, Aviano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moretto', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cordio', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Antonuzzo', 'Affiliation': 'Medical Oncology Unit, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Medical Oncology Unit, Azienda Socio-Sanitaria Territoriale of Cremona, Cremona Hospital, Cremona, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Department of Oncology, Hospital San Raffaele, IRCCS, Milan, Italy.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Di Donato', 'Affiliation': 'Department of Medical Oncology, General Hospital, Prato, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carlomagno', 'Affiliation': 'Department of Clinical Medicine and Surgery, University Federico II, Napoli, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Medical Oncology Unit, Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Ritorto', 'Affiliation': 'Struttura Semplice Dipartimentale, ColoRectal Cancer Unit, Department of Oncology, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mambrini', 'Affiliation': 'Oncological Department, Azienda UnitàSanitaria Locale, Toscana Nord Ovest, Oncological Unit of Massa Carrara, Carrara, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Roselli', 'Affiliation': 'Department of Systems Medicine, Medical Oncology Unit, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Cupini', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Azienda Toscana Nord Ovest, Livorno, Italy.'}, {'ForeName': 'Serafina', 'Initials': 'S', 'LastName': 'Mammoliti', 'Affiliation': 'Medical Oncology, IRCCS, Ospedale San Martino Istituto Scientifico Tumori, Genoa, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Fenocchio', 'Affiliation': ""Department of Medical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l'Oncologia, IRCCS, Candiolo, Italy.""}, {'ForeName': 'Enrichetta', 'Initials': 'E', 'LastName': 'Corgna', 'Affiliation': 'Unit of Medical Oncology, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Fontanini', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ugolini', 'Affiliation': 'Department of Laboratory, Pathology section, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Coordinating Center, Toscano Cancer Institute, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy. Electronic address: alfredo.falcone@med.unipi.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30862-9'] 486,31574209,Satiety testing in diabetic gastroparesis: Effects of insulin pump therapy with continuous glucose monitoring on upper gastrointestinal symptoms and gastric myoelectrical activity.,"BACKGROUND Symptoms induced by caloric or non-caloric satiety test meals and gastric myoelectrical activity (GMA) have not been studied in patients with diabetic gastroparesis (DGP) before and after intense glucose management. AIMS We determined the effects of continuous subcutaneous insulin infusion (CSII) with continuous glucose monitoring (CGM) on GI symptoms, volume consumed, and GMA induced by the caloric meal satiety test (CMST) and water load satiety test (WLST) in DGP. METHODS Forty-five patients with DGP underwent CMST and WLST at baseline and 24 weeks after CSII with CGM. Subjects ingested the test meals until they were completely full. Visual analog scales were used to quantify pre- and postmeal symptoms, and GMA was recorded with cutaneous electrodes and analyzed visually and by computer. KEY RESULTS: At baseline and 24-week visits, nausea, bloating, abdominal discomfort, and fullness were immediately increased after CMST and WLST (Ps < 0.01). The meal volumes ingested were significantly less than normal controls at both visits in almost one-third of the subjects. After the CMST, the percentage 3 cycle per minute GMA increased and bradygastria decreased compared with WLST (Ps < 0.05). After treatment for 24 weeks meal volumes ingested, postmeal symptoms and GMA were no different than baseline. CONCLUSIONS AND INFERENCES: (a) Satiety test meals elicited symptoms of nausea, bloating, and abdominal discomfort; (b) CMST stimulated more symptoms and changes in GMA than WLST; and (c) CSII with CGM for 24 weeks did not improve symptoms, volumes ingested, or GMA elicited by the two satiety test meals in these patients with diabetic GP. Satiety tests in diabetic gastropresis are useful to study acute postprandial symptoms and GMA, but these measures were not improved by intensive insulin therapy.",2020,"At baseline and 24-week visits, nausea, bloating, abdominal discomfort, and fullness were immediately increased after CMST and WLST","['patients with diabetic gastroparesis (DGP) before and after intense glucose management', 'diabetic gastroparesis', 'Forty-five patients with DGP underwent CMST and WLST at baseline and 24\xa0weeks after CSII with CGM']","['WLST ', 'caloric or non-caloric satiety test meals and gastric myoelectrical activity (GMA', 'CMST and WLST', 'insulin pump therapy with continuous glucose monitoring', 'Satiety testing', 'continuous subcutaneous insulin infusion (CSII) with continuous glucose monitoring (CGM']","['upper gastrointestinal symptoms and gastric myoelectrical activity', 'postmeal symptoms and GMA', 'nausea, bloating, and abdominal discomfort', 'nausea, bloating, abdominal discomfort, and fullness', 'percentage 3 cycle per minute GMA increased and bradygastria', 'Visual analog scales', 'GI symptoms, volume consumed, and GMA induced by the caloric meal satiety test (CMST) and water load satiety test (WLST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis co-occurrent and due to diabetes mellitus (disorder)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0857493', 'cui_str': 'Upper gastrointestinal symptoms'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort (finding)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]",45.0,0.0301565,"At baseline and 24-week visits, nausea, bloating, abdominal discomfort, and fullness were immediately increased after CMST and WLST","[{'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Koch', 'Affiliation': 'Section on Gastroenterology, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Hasler', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Van Natta', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Calles-Escandon', 'Affiliation': 'Endocrinology Section, MetroHealth Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Madhusudan', 'Initials': 'M', 'LastName': 'Grover', 'Affiliation': 'May Clinic, Rochester, Minnesota.'}, {'ForeName': 'Pankaj J', 'Initials': 'PJ', 'LastName': 'Pasricha', 'Affiliation': 'Center for Neurogastroenterology, Johns Hopkins Bayview Medical Center, Baltimore, Maryland.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Snape', 'Affiliation': 'California Pacific Medical Center, San Francisco, California.'}, {'ForeName': 'Henry P', 'Initials': 'HP', 'LastName': 'Parkman', 'Affiliation': 'Section of Gastroenterology, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Abell', 'Affiliation': 'Digestive and Liver Health, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'McCallum', 'Affiliation': 'Division of Gastroenterology, Texas Tech University, El Paso, Texas.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Nguyen', 'Affiliation': 'Division of Gastroenterology, Stanford University, Palo Alto, California.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Sarosiek', 'Affiliation': 'Division of Gastroenterology, Texas Tech University, El Paso, Texas.'}, {'ForeName': 'Gianrico', 'Initials': 'G', 'LastName': 'Farrugia', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Miriel', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hamilton', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13720'] 487,31206975,Non-invasive ventilation versus oxygen therapy in cystic fibrosis: A 12-month randomized trial.,"BACKGROUND AND OBJECTIVE No published studies have examined the long-term effects of non-invasive ventilation (NIV) in cystic fibrosis (CF). Our primary aim was to determine if adults with CF and sleep desaturation were less likely to develop hypercapnia with NIV ± O 2 compared to low-flow oxygen therapy (LFO 2 ) or meet the criteria for failure of therapy over 12 months. We studied event-free survival, hospitalizations, lung function, arterial blood gases (ABG), sleep quality and health-related quality of life. METHODS A prospective, randomized, parallel group study in adult patients with CF and sleep desaturation was conducted, comparing 12 months of NIV ± O 2 to LFO 2 . Event-free survival was defined as participants without events. Events included: failure of therapy with PaCO 2  > 60 mm Hg, or increase in PaCO 2  > 10 mm Hg from baseline, increases in TcCO 2  > 10 mm Hg, lung transplantation or death. Outcomes were measured at baseline, 3, 6 and 12 months, including lung function, ABG, Pittsburgh Sleep Quality Inventory (PSQI), SF36 and hospitalizations. RESULTS A total of 29 patients were randomized to NIV ± O 2 (n = 14) or LFO 2 (n = 15) therapy for 12 months. Of the 29 patients, 18 met the criteria for event-free survival over 12 months. NIV ± O 2 group had 33% (95% CI: 5-58%) and 46% (95% CI: 10-68%) more event-free survival at 3 and 12 months than LFO 2 group. No statistically significant differences were seen in spirometry, ABG, questionnaires or hospitalizations. CONCLUSION NIV ± O 2 during sleep increases event-free survival over 12 months in adults with CF. Further studies are required to determine which subgroups benefit the most from NIV.",2019,"No statistically significant differences were seen in spirometry, ABG, questionnaires or hospitalizations. ","['adult patients with CF and sleep desaturation was conducted, comparing 12\u2009months of NIV\u2009±\u2009O 2 to LFO 2 ', '10', 'adults with CF and sleep desaturation', '29 patients', 'cystic fibrosis (CF', 'cystic fibrosis']","['LFO 2', 'low-flow oxygen therapy (LFO 2 ', 'invasive ventilation versus oxygen therapy']","['sleep increases event-free survival', 'Event-free survival', 'TcCO 2 \u2009', 'spirometry, ABG, questionnaires or hospitalizations', 'PaCO 2 \u2009', 'failure of therapy with PaCO 2 \u2009', 'event-free survival', 'lung function, ABG, Pittsburgh Sleep Quality Inventory (PSQI), SF36 and hospitalizations', 'mm Hg, lung transplantation or death', 'survival, hospitalizations, lung function, arterial blood gases (ABG), sleep quality and health-related quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",29.0,0.275942,"No statistically significant differences were seen in spirometry, ABG, questionnaires or hospitalizations. ","[{'ForeName': 'Maree A', 'Initials': 'MA', 'LastName': 'Milross', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Piper', 'Affiliation': 'Faculty of Health and Medicine, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tiffany J', 'Initials': 'TJ', 'LastName': 'Dwyer', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Faculty of Health and Medicine, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Bell', 'Affiliation': 'The Prince Charles Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Peter T P', 'Initials': 'PTP', 'LastName': 'Bye', 'Affiliation': 'Faculty of Health and Medicine, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Respirology (Carlton, Vic.)",['10.1111/resp.13604'] 488,31571095,Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial.,"BACKGROUND Darolutamide, an androgen receptor antagonist with a distinct molecular structure, significantly prolonged metastasis-free survival versus placebo in the phase III ARAMIS study in men with nonmetastatic castration-resistant prostate cancer (nmCRPC). In this population, polypharmacy for age-related comorbidities is common and may increase drug-drug interaction (DDI) risks. Preclinical/phase I study data suggest darolutamide has a low DDI potential-other than breast cancer resistance protein/organic anion transporter protein substrates (e.g., statins), no clinically relevant effect on comedications is expected. OBJECTIVE Our objective was to evaluate the effect of commonly administered drugs on the pharmacokinetics of darolutamide and the effect of comedications potentially affected by darolutamide on safety in patients with nmCRPC. PATIENTS AND METHODS Comorbidities and comedication use in the 1509 ARAMIS participants treated with darolutamide 600 mg twice daily or placebo were assessed. A population pharmacokinetic analysis evaluated whether comedications affected the pharmacokinetics of darolutamide in a subset of 388 patients. A subgroup analysis of adverse events (AEs) in statin users versus nonusers was conducted. RESULTS Most participants (median age 74 years) had at least one comorbidity (98.4% in both arms) and used at least one comedication (98.7% with darolutamide vs. 98.0% with placebo); these were similar across study arms. Despite frequent use of comedications with DDI potential, no significant effects on darolutamide pharmacokinetics were identified. Comedications included lipid-modifying agents (34.5%), β-blockers (29.7%), antithrombotics (42.8%), and systemic antibiotics (26.9%). AE incidence was similar across study arms in statin users and nonusers. Study limitations include the small sample size for sub-analyses. CONCLUSIONS These analyses suggest the pharmacokinetic profile of darolutamide is not affected by a number of commonly administered drugs in patients with nmCRPC. Although pharmacokinetic data have indicated that darolutamide has the potential to interact with rosuvastatin, used to assess DDI in these studies, this finding did not seem to translate into increased AEs due to statin use in the ARAMIS trial. Clinicaltrials.gov identifier: NCT02200614.",2019,"BACKGROUND Darolutamide, an androgen receptor antagonist with a distinct molecular structure, significantly prolonged metastasis-free survival versus placebo in the phase III ARAMIS study in men with nonmetastatic castration-resistant prostate cancer (nmCRPC).","['patients with nmCRPC', 'Patients with Nonmetastatic Castration-Resistant Prostate Cancer', 'Comorbidities and comedication use in the 1509 ARAMIS participants treated with', 'men with nonmetastatic castration-resistant prostate cancer (nmCRPC', '388 patients']","['placebo', 'darolutamide', 'rosuvastatin']","['systemic antibiotics', 'darolutamide pharmacokinetics', 'AE incidence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",388.0,0.431686,"BACKGROUND Darolutamide, an androgen receptor antagonist with a distinct molecular structure, significantly prolonged metastasis-free survival versus placebo in the phase III ARAMIS study in men with nonmetastatic castration-resistant prostate cancer (nmCRPC).","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, 823 82nd Parkway, Suite B, Myrtle Beach, SC, 29572, USA. NShore@gsuro.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zurth', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fricke', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Hille', 'Initials': 'H', 'LastName': 'Gieschen', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Graudenz', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Koskinen', 'Affiliation': 'Orion Corporation Orion Pharma, Espoo, Finland.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Ploeger', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': 'BAST Inc. Ltd., Loughborough, UK.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Prien', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Borghesi', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Tampere University Hospital and Tampere University, Tampere, Finland.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kuss', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Verholen', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, Université Paris-Sud, Villejuif, France.'}]",Targeted oncology,['10.1007/s11523-019-00674-0'] 489,30842951,A randomized controlled field trial of iBsafe-a novel child safety game app.,"Background Injury is a leading cause of child morbidity and mortality worldwide. Delivering injury prevention programs via mobile platforms, such as applications (apps), may reduce risky behaviors. iBsafe is an ""interactive Bike and Bite safety"" mobile game app founded in behavioral theory and designed to educate kindergarten-aged children about bicycle and dog-related safety. This study assessed the relationship of iBsafe game play and child safety knowledge and skills; hypothesizing that iBsafe increases safety knowledge with translation to practice. Methods This single-blinded, randomized, controlled field trial included sixty 5-6-year-old children. Parent-child dyads were randomly assigned to receive a weeklong field trial of iBsafe or control. Pre- and post-intervention safety knowledge tests were completed; post-intervention safety skills assessments occurred in a simulated safety lab using real props (i.e., safety street, bicycles, and live dogs). The primary outcome was child bicycle and dog-related safety knowledge and skills performance. Performance was assessed by blinded reviewers. Secondary outcomes included frequency of safety discussion in groups and iBsafe acceptability. Results Thirty children were randomized to each group; there were no substantial demographic differences between groups. Compared to controls, post-intervention iBsafe children had higher bicycle and dog-related safety knowledge scores (9.2±0.9 vs. 8.7±1.0, P=0.029 and 8.2±2.1 vs. 6.7±1.8, P=0.003, respectively); and they exhibited more safety skills (median number bicycle skills 5 vs. 4, P=0.007; median number dog-related skills 5 vs. 3, P<0.001, respectively). Frequency of safety conversations increased among intervention families during the trial, and iBsafe acceptability was near universal. Conclusions iBsafe was effective at increasing child safety knowledge and improving safety skills. Child injury prevention programs that embrace interactive mobile platforms may expand reach and possibly decrease injury outcomes.",2019,"Compared to controls, post-intervention iBsafe children had higher bicycle and dog-related safety knowledge scores (9.2±0.9 vs. 8.7±1.0, P=0.029 and 8.2±2.1 vs. 6.7±1.8, P=0.003, respectively); and they exhibited more safety skills (median number bicycle skills 5 vs. 4, P=0.007; median number dog-related skills 5 vs. 3, P<0.001, respectively).","['Thirty children', 'sixty 5-6-year-old children', 'Parent-child dyads']",['iBsafe or control'],"['child safety knowledge and improving safety skills', 'safety skills', 'Frequency of safety conversations', 'higher bicycle and dog-related safety knowledge scores', 'frequency of safety discussion in groups and iBsafe acceptability', 'safety street, bicycles, and live dogs', 'child bicycle and dog-related safety knowledge and skills performance']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}]",30.0,0.396744,"Compared to controls, post-intervention iBsafe children had higher bicycle and dog-related safety knowledge scores (9.2±0.9 vs. 8.7±1.0, P=0.029 and 8.2±2.1 vs. 6.7±1.8, P=0.003, respectively); and they exhibited more safety skills (median number bicycle skills 5 vs. 4, P=0.007; median number dog-related skills 5 vs. 3, P<0.001, respectively).","[{'ForeName': 'Cinnamon A', 'Initials': 'CA', 'LastName': 'Dixon', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado, Aurora, CO, USA.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Ammerman', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Boyd L', 'Initials': 'BL', 'LastName': 'Johnson', 'Affiliation': 'AECOM-Denver, Greenwood Village, CO, USA.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Lampe', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Kimberly W', 'Initials': 'KW', 'LastName': 'Hart', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'E Melinda', 'Initials': 'EM', 'LastName': 'Mahabee-Gittens', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.""}]",mHealth,['10.21037/mhealth.2019.01.02'] 490,31174929,A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder.,"The purpose of this study was to pilot-test a mind-body intervention called Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to buprenorphine for individuals with opioid use disorder (OUD). MABT, a manualized 8 week protocol, teaches interoceptive awareness skills to promote self-care and emotion regulation. A small study was designed to assess MABT recruitment and retention feasibility, and intervention acceptability, among this population. Individuals were recruited from two office-based programs providing buprenorphine treatment within a large urban community medical center. Participants were randomized to receive either treatment as usual (TAU), or TAU plus MABT. Assessments administered at baseline and 10-week follow-up included validated self-report health questionnaires and a process measure, the Multidimensional Assessment of Interoceptive Awareness, to examine interoceptive awareness skills. An additional survey and exit interview for those in the MABT study arm were administered to assess intervention satisfaction. Results showed the ability to recruit and enroll 10 participants within two-weeks, and no loss to follow-up. The MABT study group showed an increase in interoceptive awareness skills from baseline to follow-up, whereas the control group did not. Responses to the satisfaction questionnaire and exit interview were positive, indicating skills learned, satisfaction with the interventionists, and overall perceived benefit of the intervention. In summary, study results demonstrated recruitment and retention feasibility, and high intervention acceptability. This pilot study suggests preliminary feasibility of successfully implementing a larger study of MABT as an adjunct to office-based medication treatment for opioid use disorder.",2020,Individuals were recruited from two office-based programs providing buprenorphine treatment within a large urban community medical center.,"['treatment within a large urban community medical center', 'individuals with opioid use disorder (OUD']","['mind-body intervention called Mindful Awareness in Body-oriented Therapy (MABT', 'buprenorphine', 'usual (TAU), or TAU plus MABT', 'mindful body awareness training', 'MABT']","['MABT recruitment and retention feasibility, and intervention acceptability', 'interoceptive awareness skills']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C1562642', 'cui_str': 'Community medical center'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",10.0,0.0286996,Individuals were recruited from two office-based programs providing buprenorphine treatment within a large urban community medical center.,"[{'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Price', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington, Box 357266, Seattle, WA 98195, USA. Electronic address: cynthiap@uw.edu.'}, {'ForeName': 'Joseph O', 'Initials': 'JO', 'LastName': 'Merrill', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Harborview Medical Center, 325 Ninth Ave, Seattle, WA 98195, USA.'}, {'ForeName': 'Rachelle L', 'Initials': 'RL', 'LastName': 'McCarty', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington, Box 357266, Seattle, WA 98195, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Pike', 'Affiliation': 'Department of Psychosocial and Community Health Nursing, University of Washington, Box 357263, Seattle, WA 98185, USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Harborview Medical Center, 325 Ninth Ave, Seattle, WA 98195, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.05.013'] 491,32241751,Effects of an extrinsic motivator on the evaluation of cognitive and daily living functions in patients with schizophrenia.,"We investigated the effect of an extrinsic motivator on the MATRICS Consensus Cognitive Battery (MCCB) and UCSD Performance-Based Skills Assessment (UPSA) scores, which assess cognitive and daily living functions, in patients with schizophrenia. We enrolled 60 clinically stable patients with schizophrenia and allocated them to the motivator or control group. We conducted baseline assessments of cognitive function using the MCCB, daily living function using the UPSA, clinical symptoms, and psychosocial characteristics in both groups. In the retrial, we initially evaluated clinical symptoms. Next, we assigned an extrinsic motivator to the motivator group and again assessed cognitive function and daily living function using the MCCB and UPSA. Statistical analyses were performed using t-tests, Chi-square tests, Fisher's exact test, repeated measures analysis of variance, and logistic regression analysis. We found significant time × group interactions in processing speed, verbal learning, visual learning, and composite scores of MCCB. There were no significant interactions in UPSA scores. The meaningful change rates of social cognition and composite scores in MCCB were significantly higher in the motivator group than in the control group. After adjusting for additional variables, the extrinsic motivator had a significant effect on the meaningful MCCB composite score change. Conclusively, our findings suggest beneficial effects of extrinsic motivator on the MCCB score in patients with schizophrenia. In the future, the implementation and interpretation of the MCCB considering the motivation is necessary.",2020,"We found significant time × group interactions in processing speed, verbal learning, visual learning, and composite scores of MCCB.","['enrolled 60 clinically stable patients with schizophrenia and allocated them to the motivator or control group', 'patients with schizophrenia']",['extrinsic motivator'],"['meaningful MCCB composite score change', 'processing speed, verbal learning, visual learning, and composite scores of MCCB', 'Consensus Cognitive Battery (MCCB) and UCSD Performance-Based Skills Assessment (UPSA) scores', 'evaluation of cognitive and daily living functions', 'UPSA scores', 'MCCB score', 'social cognition and composite scores in MCCB', 'cognitive function and daily living function']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",60.0,0.0185012,"We found significant time × group interactions in processing speed, verbal learning, visual learning, and composite scores of MCCB.","[{'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Do-Un', 'Initials': 'DU', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea. Electronic address: gabriel.jdu@gmail.com.'}, {'ForeName': 'Jung-Joon', 'Initials': 'JJ', 'LastName': 'Moon', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Young-Soo', 'Initials': 'YS', 'LastName': 'Seo', 'Affiliation': 'Department of Psychiatry, Sharing and Happiness Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, Sharing and Happiness Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Yoo-Chul', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Busan Metropolitan Mental Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jeong-Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Busan Metropolitan Mental Hospital, Busan, Republic of Korea.'}]",Schizophrenia research,['10.1016/j.schres.2020.03.036'] 492,32171426,"Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study.","BACKGROUND CLEOPATRA was a phase 3 study comparing the efficacy and safety of pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel in patients with HER2-positive metastatic breast cancer. In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group. Here, we report the end-of-study analysis of CLEOPATRA. METHODS This was a double-blind, randomised, placebo-controlled, phase 3 trial that was done at 204 centres in 25 countries. Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer, had not received previous chemotherapy or biological treatment for their metastatic disease, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. All study drugs were given intravenously, every 3 weeks. Patients were assigned to receive either pertuzumab or placebo at a loading dose of 840 mg, and 420 mg thereafter; plus trastuzumab at 8 mg/kg loading dose and 6 mg/kg thereafter; and docetaxel at 75 mg/m 2 , escalating to 100 mg/m 2 if tolerated. Pertuzumab or placebo and trastuzumab were given until disease progression; docetaxel was given for six cycles, or longer at the investigators' discretion. Randomisation (1:1) was done by use of an interactive voice-response system and was stratified by geographical region (Asia, Europe, North America, or South America) and previous treatment (previous adjuvant or neoadjuvant chemotherapy vs none). The primary endpoint was independent review facility-assessed progression-free survival, which has been reported previously. Since the confirmatory overall survival analysis had also occurred before this prespecified end-of-study analysis, analyses presented here are descriptive. Overall survival analyses were based on the intention-to-treat population with crossover patients analysed in the placebo group; analyses were not adjusted for crossover to the pertuzumab group and are likely to be conservative. Safety analyses were based on treatment received; crossover patients were counted in the placebo group up to the day before first pertuzumab dose. This trial is registered with ClinicalTrials.gov, number NCT00567190. FINDINGS Between Feb 12, 2008, and July 7, 2010, 1196 patients were assessed for eligibility, of whom 808 were enrolled and randomly assigned. 402 patients were assigned to receive docetaxel plus trastuzumab plus pertuzumab, and 406 patients were assigned to receive docetaxel plus trastuzumab plus placebo. Clinical cutoff for this analysis was Nov 23, 2018. Between July 2012 and clinical cutoff, 50 patients crossed from the placebo to the pertuzumab group. Median follow-up was 99·9 months in the pertuzumab group (IQR 92·9-106·4) and 98·7 months (90·9-105·7) in the placebo group. Median overall survival was 57·1 months (95% CI 50-72) in the pertuzumab group and 40·8 months (36-48) in the placebo group (hazard ratio 0·69, 95% CI 0·58-0·82); 8-year landmark overall survival rates were 37% (95% CI 31-42) in the pertuzumab group and 23% (19-28) in the placebo group. The most common grade 3-4 adverse event was neutropenia (200 [49%] of 408 patients in the pertuzumab group, 183 [46%] of 396 patients in the placebo group). Five (1%) of 408 patients in the pertuzumab group and six (2%) of 396 patients in the placebo group had treatment-related deaths. One new serious adverse event suggestive of congestive heart failure (pertuzumab group) and one new symptomatic left ventricular systolic dysfunction (post-crossover) occurred since the previous analysis. INTERPRETATION Our analysis shows that the previously observed improvements in overall survival with pertuzumab, trastuzumab, and docetaxel versus placebo, trastuzumab, and docetaxel were maintained after a median of more than 8 years of follow-up. The long-term safety and cardiac safety profiles of pertuzumab, trastuzumab, and docetaxel were maintained in the overall safety population and within crossover patients. HER2-targeted therapy has changed the natural history of HER2-positive metastatic breast cancer, with the dual blockade of pertuzumab and trastuzumab, with docetaxel, demonstrating an 8-year landmark overall survival rate of 37%. FUNDING F Hoffmann-La Roche and Genentech.",2020,"In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group.","['1196 patients were assessed for eligibility, of whom 808 were enrolled and randomly assigned', 'patients with HER2-positive metastatic breast cancer', 'HER2-positive metastatic breast cancer (CLEOPATRA', ' and 406 patients', 'Between Feb 12, 2008, and July 7, 2010', '204 centres in 25 countries', 'Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer, had not received previous chemotherapy or biological treatment for their metastatic disease, and had an Eastern Cooperative Oncology Group performance status of 0 or 1', '402 patients']","['pertuzumab, trastuzumab, and docetaxel versus placebo, trastuzumab, and docetaxel', 'trastuzumab', 'docetaxel plus trastuzumab\u2008plus\u2008placebo', 'docetaxel plus trastuzumab\u2008plus\u2008pertuzumab', 'HER2-targeted therapy', 'placebo', 'pertuzumab or placebo', 'docetaxel', 'pertuzumab, trastuzumab, and docetaxel', 'Pertuzumab or placebo and trastuzumab', 'pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel', 'Pertuzumab, trastuzumab, and docetaxel']","['overall survival', 'treatment-related deaths', '8-year landmark overall survival rates', 'Overall survival analyses', 'Median overall survival', 'neutropenia', 'progression-free and overall survival', 'review facility-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0323987', 'cui_str': 'Cleopatra'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1531518', 'cui_str': 'Biological treatment'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1196.0,0.69218,"In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group.","[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Georgetown University Medical Center, Washington DC, USA; Lombardi Comprehensive Cancer Center, Washington, DC, USA; MedStar Health, Washington, DC, USA. Electronic address: sandra.swain@georgetown.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Semiglazov', 'Affiliation': 'N N Petrov Research Institute of Oncology, St Petersburg, Russia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': '12 de Octubre University Hospital, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, University Hospital, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Monturus', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Knott', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Restuccia', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Benyunes', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""IOB Institute of Oncology, Quirónsalud Group, Madrid and Barcelona, Spain; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30863-0'] 493,32171429,"Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial.","BACKGROUND With increasingly precise radiotherapy and advanced medical imaging, the concept of radiotherapy target volume planning might be redefined with the aim of improving outcomes. We aimed to investigate whether target volume reduction is feasible and effective compared with conventional planning in the context of radical chemoradiotherapy for patients with locally advanced non-small-cell lung cancer. METHODS We did a multicentre, open-label, randomised, controlled trial (PET-Plan; ARO-2009-09) in 24 centres in Austria, Germany, and Switzerland. Previously untreated patients (aged older than 18 years) with inoperable locally advanced non-small-cell lung cancer suitable for chemoradiotherapy and an Eastern Cooperative Oncology Group performance status of less than 3 were included. Undergoing 18 F-fluorodeoxyglucose ( 18 F-FDG) PET and CT for treatment planning, patients were randomly assigned (1:1) using a random number generator and block sizes between four and six to target volume delineation informed by 18 F-FDG PET and CT plus elective nodal irradiation (conventional target group) or target volumes informed by PET alone ( 18 F-FDG PET-based target group). Randomisation was stratified by centre and Union for International Cancer Control stage. In both groups, dose-escalated radiotherapy (60-74 Gy, 2 Gy per fraction) was planned to the respective target volumes and applied with concurrent platinum-based chemotherapy. The primary endpoint was time to locoregional progression from randomisation with the objective to test non-inferiority of 18 F-FDG PET-based planning with a prespecified hazard ratio (HR) margin of 1·25. The per-protocol set was included in the primary analysis. The safety set included all patients receiving any study-specific treatment. Patients and study staff were not masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT00697333. FINDINGS From May 13, 2009, to Dec 5, 2016, 205 of 311 recruited patients were randomly assigned to the conventional target group (n=99) or the 18 F-FDG PET-based target group (n=106; the intention-to-treat set), and 172 patients were treated per protocol (84 patients in the conventional target group and 88 in the 18 F-FDG PET-based target group). At a median follow-up of 29 months (IQR 9-54), the risk of locoregional progression in the 18 F-FDG PET-based target group was non-inferior to, and in fact lower than, that in the conventional target group in the per-protocol set (14% [95% CI 5-21] vs 29% [17-38] at 1 year; HR 0·57 [95% CI 0·30-1·06]). The risk of locoregional progression in the 18 F-FDG PET-based target group was also non-inferior to that in the conventional target group in the intention-to-treat set (17% [95% CI 9-24] vs 30% [20-39] at 1 year; HR 0·64 [95% CI 0·37-1·10]). The most common acute grade 3 or worse toxicity was oesophagitis or dysphagia (16 [16%] of 99 patients in the conventional target group vs 17 [16%] of 105 patients in the 18 F-FDG PET-based target group); the most common late toxicities were lung-related (12 [12%] vs 11 [10%]). 20 deaths potentially related to study treatment were reported (seven vs 13). INTERPRETATION 18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer. Imaging-based target volume reduction in this setting is, therefore, feasible, and could potentially be considered standard of care. The procedures established might also support imaging-based target volume reduction concepts for other tumours. FUNDING German Cancer Aid (Deutsche Krebshilfe).",2020,"INTERPRETATION 18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer.","['locally advanced non-small-cell lung cancer (PET-Plan', 'patients with locally advanced non-small-cell lung cancer', '24 centres in Austria, Germany, and Switzerland', 'From May 13, 2009, to Dec 5, 2016, 205 of 311 recruited patients', 'Previously untreated patients (aged older than 18 years) with inoperable locally advanced non-small-cell lung cancer suitable for chemoradiotherapy and an Eastern Cooperative Oncology Group performance status of less than 3 were included', 'patients receiving any study-specific treatment', 'patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer']","['conventional planning', 'Imaging-based target volume reduction in chemoradiotherapy', 'concurrent platinum-based chemotherapy', 'conventional target group (n=99) or the 18 F-FDG PET-based target group', 'radiotherapy', 'radical chemoradiotherapy', 'random number generator and block sizes between four and six to target volume delineation informed by 18 F-FDG PET and CT plus elective nodal irradiation (conventional target group) or target volumes informed by PET alone ( 18 F-FDG PET-based target group', 'Undergoing 18 F-fluorodeoxyglucose ( 18 F-FDG) PET and CT']","['toxicity was oesophagitis or dysphagia', 'time to locoregional progression from randomisation with the objective to test non-inferiority of 18 F-FDG PET-based planning with a prespecified hazard ratio (HR) margin of 1·25', 'risk of locoregional progression', 'toxicity', 'late toxicities']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",311.0,0.27767,"INTERPRETATION 18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany; Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany. Electronic address: ursula.nestle@mariahilf.de.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Schimek-Jasch', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kremp', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaefer-Schuler', 'Affiliation': 'Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mix', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Küsters', 'Affiliation': 'Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tosch', 'Affiliation': 'Department of Nuclear Medicine, Helios University Hospital Wuppertal, Wuppertal, Germany; Department of Medicine, Faculty of Health, University of Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hehr', 'Affiliation': 'Department of Radiation Oncology, Marienhospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Susanne Martina', 'Initials': 'SM', 'LastName': 'Eschmann', 'Affiliation': 'Department of Nuclear Medicine, Marienhospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Yves-Pierre', 'Initials': 'YP', 'LastName': 'Bultel', 'Affiliation': 'Department of Radiation Oncology, Klinikum Mutterhaus der Boromäerinnen, Trier, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hass', 'Affiliation': 'Department of Radiation Oncology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Thieme', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Department of Radiation Oncology, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Stockinger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dieckmann', 'Affiliation': 'Department of Radiotherapy, Medical University of Vienna, Vienna General Hospital, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Miederer', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Holl', 'Affiliation': 'Department of Nuclear Medicine, Helios Kliniken Schwerin, Schwerin, Germany.'}, {'ForeName': 'H Christian', 'Initials': 'HC', 'LastName': 'Rischke', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; Department of Nuclear Medicine, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gkika', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Adebahr', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30013-9'] 494,32208439,Effect of four classes of antihypertensive drugs on cardiac repolarization heterogeneity: A double-blind rotational study.,"BACKGROUND T-wave area dispersion (TW-Ad) is a novel electrocardiographic (ECG) repolarization marker associated with sudden cardiac death. However, limited data is available on the clinical correlates of TW-Ad. In addition, there are no previous studies on cardiovascular drug effects on TW-Ad. In this study, we examined the relation between TW-Ad and left ventricular mass. We also studied the effects of four commonly used antihypertensive drugs on TW-Ad. METHODS A total of 242 moderately hypertensive males (age, 51±6 years; office systolic/diastolic blood pressure during placebo, 153±14/100±8 mmHg), participating in the GENRES study, were included. Left ventricular mass index was determined by transthoracic echocardiography. Antihypertensive four-week monotherapies (a diuretic, a beta-blocker, a calcium channel blocker, and an angiotensin receptor antagonist) were administered in a randomized rotational fashion. Four-week placebo periods preceded all monotherapies. The average value of measurements (over 1700 ECGs in total) from all available placebo periods served as a reference to which measurements during each drug period were compared. RESULTS Lower, i.e. risk-associated TW-Ad values correlated with a higher left ventricular mass index (r = -0.14, p = 0.03). Bisoprolol, a beta-blocker, elicited a positive change in TW-Ad (p = 1.9×10-5), but the three other drugs had no significant effect on TW-Ad. CONCLUSIONS Our results show that TW-Ad is correlated with left ventricular mass and can be modified favorably by the use of bisoprolol, although demonstration of any effects on clinical endpoints requires long-term prospective studies. Altogether, our results suggest that TW-Ad is an ECG repolarization measure of left ventricular arrhythmogenic substrate.",2020,"Bisoprolol, a beta-blocker, elicited a positive change in TW-Ad (p = 1.9×10-5), but the three other drugs had no significant effect on TW-Ad","['A total of 242 moderately hypertensive males (age, 51±6 years; office systolic/diastolic blood pressure during placebo, 153±14/100±8 mmHg), participating in the GENRES study, were included']","['antihypertensive drugs', 'placebo', 'Antihypertensive four-week monotherapies (a diuretic, a beta-blocker, a calcium channel blocker, and an angiotensin receptor antagonist']","['cardiac repolarization heterogeneity', 'ECG repolarization measure of left ventricular arrhythmogenic substrate', 'TW-Ad', 'Left ventricular mass index']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}]","[{'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",242.0,0.136879,"Bisoprolol, a beta-blocker, elicited a positive change in TW-Ad (p = 1.9×10-5), but the three other drugs had no significant effect on TW-Ad","[{'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Sánez Tähtisalo', 'Affiliation': 'Department of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Timo P', 'Initials': 'TP', 'LastName': 'Hiltunen', 'Affiliation': 'Department of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Kenttä', 'Affiliation': 'Research Unit of Internal Medicine, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Junttila', 'Affiliation': 'Research Unit of Internal Medicine, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Oikarinen', 'Affiliation': 'Division of Cardiology, Heart and Lung Center, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Virolainen', 'Affiliation': 'Division of Cardiology, Heart and Lung Center, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo K', 'Initials': 'KK', 'LastName': 'Kontula', 'Affiliation': 'Department of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Porthan', 'Affiliation': 'Division of Cardiology, Heart and Lung Center, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}]",PloS one,['10.1371/journal.pone.0230655'] 495,32208443,"Differences in the performance of resuscitation according to the resuscitation guideline terminology during infant cardiopulmonary resuscitation: ""Approximately 4 cm"" versus ""at least one-third the anterior-posterior diameter of the chest"".","AIM This study was conducted to investigate the effect of resuscitation guideline terminology on the performance of infant cardiopulmonary resuscitation (CPR). METHODS A total of 40 intern or resident physicians conducted 2-min CPR with the two-finger technique (TFT) and two-thumb technique (TT) on a simulated infant cardiac arrest model with a 1-day interval. They were randomly assigned to Group A or B. The participants of Group A conducted CPR with the chest compression depth (CCD) target of ""approximately 4 cm"" and those of Group B conducted CPR with the CCD target of ""at least one-third the anterior-posterior diameter of the chest"". Single rescuer CPR was performed with a 15:2 compression to ventilation ratio on the floor. RESULTS In both chest compression techniques, the average CCD of Group B was significantly deeper than that of Group A (TFT: 41.0 [range, 39.3-42.0] mm vs. 36.5 [34.0-37.9] mm, P = 0.002; TT: 42.0 [42.0-43.0] mm vs. 37.0 [35.3-38.0] mm, P < 0.001). Adequacy of CCD also showed similar results (Group B vs. A; TFT: 99% [82-100%] vs. 29% [12-58%], P = 0.001; TT: 100% [100-100%] vs. 28% [8-53%], P < 0.001). CONCLUSIONS Using the CCD target of ""at least one-third the anterior-posterior diameter of the chest"" resulted in deep and adequate chest compressions during simulated infant CPR in contrast to the CCD target of ""approximately 4 cm"". Therefore, changes in the terminology used in the guidelines should be considered to improve the quality of CPR. TRIAL REGISTRATION Clinical Research Information Service; cris.nih.go.kr/cris/en (Registration number: KCT0003486).",2020,"In both chest compression techniques, the average CCD of Group B was significantly deeper than that of Group A (TFT: 41.0 [range, 39.3-42.0] mm vs. 36.5 [34.0-37.9] mm, P = 0.002; TT: 42.0 [42.0-43.0] mm vs. 37.0 [35.3-38.0] mm, P < 0.001).",[],"['resuscitation guideline terminology', 'TFT', '40 intern or resident physicians conducted 2-min CPR with the two-finger technique (TFT) and two-thumb technique (TT']",[],[],"[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}]",[],,0.0590075,"In both chest compression techniques, the average CCD of Group B was significantly deeper than that of Group A (TFT: 41.0 [range, 39.3-42.0] mm vs. 36.5 [34.0-37.9] mm, P = 0.002; TT: 42.0 [42.0-43.0] mm vs. 37.0 [35.3-38.0] mm, P < 0.001).","[{'ForeName': 'Wongyu', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dongjun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Je Hyeok', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0230687'] 496,31542368,Symptom improvement in dry eye subjects following intranasal tear neurostimulation: Results of two studies utilizing a controlled adverse environment.,"PURPOSE To evaluate the safety and effectiveness of the intranasal tear neurostimulator (ITN) in improving dry eye symptoms assessed in a controlled adverse environment (CAE®). METHODS Study 1: Multicenter, subject-masked, randomized-sequence, crossover design. Single intranasal (active) and extranasal (control) ITN administration during CAE exposure. Study 2: Single-arm, open-label design. Intranasal ITN administration ≥2 times/day for 45 days, CAE assessment at days 0 and 45. In both studies, upon CAE entry, and every 5 min thereafter, subjects assessed eye dryness score (visual analog scale, 0-100 mm; EDS-VAS), and ocular discomfort score (ODS; Ora Calibra™, 0-4), for ≈2 h. Study 1: when ODS was ≥3 at 2 consecutive timepoints, subjects applied ITN intranasally or extranasally for ≈3 min, and again when achieving the same ODS criteria in randomized sequence. Study 2: days 0 and 45, ITN was applied for ≈3 min employing the same ODS criteria as Study 1. RESULTS Study 1: Significantly greater pre- to post-application reductions in mean [SEM] EDS (-16.5 [1.7] vs -3.1 [1.7], P < 0.0001) and ODS (-0.93 [0.08] vs -0.34 [0.08], P < 0.0001; n = 143) with intranasal vs extranasal stimulation. Study 2: On day 0 (n = 52) and day 45 (n = 48), significant pre- to post-application reductions in mean [SEM] EDS (-15.9 [2.7] and -15.2 [2.4]; P < 0.0001), and ODS (-1.3 [0.2] and -1.3 [0.1]; P < 0.0001). Few device-related adverse events were reported, none serious. CONCLUSIONS Acute symptom relief is significant with the ITN and remains undiminished after daily use.",2020,"Few device-related adverse events were reported, none serious. ",[],"['intranasal tear neurostimulator (ITN', 'intranasal tear neurostimulation', 'Single intranasal (active) and extranasal (control) ITN']","['safety and effectiveness', 'eye dryness score (visual analog scale, 0-100\u202fmm; EDS-VAS), and ocular discomfort score', 'ODS ', 'ODS']",[],"[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator, device (physical object)'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}]",,0.0356093,"Few device-related adverse events were reported, none serious. ","[{'ForeName': 'Guruprasad R', 'Initials': 'GR', 'LastName': 'Pattar', 'Affiliation': 'The Eye Care Institute, Louisville, KY, USA. Electronic address: drpattar@eyecareinstitute.com.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Jerkins', 'Affiliation': 'Advancing Vision Research LLC, Nashville, TN, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': 'Total Eye Care, P.A., Memphis, TN, USA.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Torkildsen', 'Affiliation': 'Andover Eye Associates, Inc, Andover, MA, USA.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Ousler', 'Affiliation': 'Ora Inc., Andover, MA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hollander', 'Affiliation': 'Ora Inc., Andover, MA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holdbrook', 'Affiliation': 'Allergan plc, Pleasanton, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Senchyna', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}]",The ocular surface,['10.1016/j.jtos.2019.09.006'] 497,32112738,"Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label, parallel-group, randomised, phase 2 trial.","BACKGROUND Blocking the interaction between PD-1 and its ligands is a promising treatment strategy for advanced hepatocellular carcinoma. This study aimed to assess the antitumour activity and safety of the anti-PD-1 inhibitor camrelizumab in pretreated patients with advanced hepatocellular carcinoma. METHODS This is a multicentre, open-label, parallel-group, randomised, phase 2 trial done at 13 study sites in China. Eligible patients were aged 18 years and older with a histological or cytological diagnosis of advanced hepatocellular carcinoma, had progressed on or were intolerant to previous systemic treatment, and had an Eastern Cooperative Oncology Group performance score of 0-1. Patients were randomly assigned (1:1) to receive camrelizumab 3 mg/kg intravenously every 2 or 3 weeks, via a centralised interactive web-response system using block randomisation (block size of four). The primary endpoints were objective response (per blinded independent central review) and 6-month overall survival, in all randomly assigned patients who had at least one dose of study treatment. Safety was analysed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02989922, and follow-up is ongoing, but enrolment is closed. FINDINGS Between Nov 15, 2016, and Nov 16, 2017, 303 patients were screened for eligibility, of whom 220 eligible patients were randomly assigned and among whom 217 received camrelizumab (109 patients were given treatment every 2 weeks and 108 every 3 weeks). Median follow-up was 12·5 months (IQR 5·7-15·5). Objective response was reported in 32 (14·7%; 95% CI 10·3-20·2) of 217 patients. The overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)]. Grade 3 or 4 treatment-related adverse events occurred in 47 (22%) of 217 patients; the most common were increased aspartate aminotransferase (ten [5%]) and decreased neutrophil count (seven [3%]). Two deaths were judged by the investigators to be potentially treatment-related (one due to liver dysfunction and one due to multiple organ failure). INTERPRETATION Camrelizumab showed antitumour activity in pretreated Chinese patients with advanced hepatocellular carcinoma, with manageable toxicities, and might represent a new treatment option for these patients. FUNDING Jiangsu Hengrui Medicine.",2020,The overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)].,"['pretreated Chinese patients with advanced hepatocellular carcinoma', 'Eligible patients were aged 18 years and older with a histological or cytological diagnosis of advanced hepatocellular carcinoma, had progressed on or were intolerant to previous systemic treatment, and had an Eastern Cooperative Oncology Group performance score of 0-1', 'Between Nov 15, 2016, and Nov 16, 2017, 303 patients were screened for eligibility, of whom 220 eligible patients', 'pretreated patients with advanced hepatocellular carcinoma', '13 study sites in China', 'patients with previously treated advanced hepatocellular carcinoma', 'advanced hepatocellular carcinoma']","['camrelizumab', 'camrelizumab 3 mg/kg intravenously every 2 or 3 weeks, via a centralised interactive web-response system using block randomisation (block size of four', 'Camrelizumab', 'anti-PD-1 inhibitor camrelizumab']","['Objective response', 'neutrophil count', 'objective response (per blinded independent central review) and 6-month overall survival', 'antitumour activity', 'overall survival probability', 'adverse events', 'aspartate aminotransferase', 'antitumour activity and safety', 'Safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",303.0,0.351536,The overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)].,"[{'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Centre of Jinling Hospital, Nanjing, China. Electronic address: qinsk@csco.org.cn.'}, {'ForeName': 'Zhenggang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Minimally Invasive Therapy Center, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Intervention, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Third Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Medical Oncology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Interventional Radiology, Cancer Center, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Enxiao', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, First Affiliated Hospital of Xi'an Jiaotong University (School of Medicine), Xi'an, China.""}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30011-5'] 498,32242760,"Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial.","Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet ""app"") with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.",2020,"Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided.","['Biospecimen Research', 'three Michigan hospitals to compare two different']","['consent processes (video and interactive tablet ""app"") with standard brochure-based consent in the Michigan BioTrust for Health']","['knowledge scores', 'satisfaction, amount of information, and clarity']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}]",3.0,0.0564352,"Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided.","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rothwell', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Goldenberg', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Tarini', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Riches', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Louisa A', 'Initials': 'LA', 'LastName': 'Stark', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pries', 'Affiliation': 'Spectrum Health System, Grand Rapids, MI, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Langbo', 'Affiliation': 'InformedDNA, St. Petersburg, FL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Langen', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Botkin', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}]",Journal of empirical research on human research ethics : JERHRE,['10.1177/1556264620913455'] 499,32057962,Clinical utility of 30-min plasma glucose for prediction of type 2 diabetes among people with prediabetes: Ancillary analysis of the diabetes community lifestyle improvement program.,"AIMS To examine the clinical utility of 30-min plasma glucose (30-min-PG) measurement during an oral glucose tolerance (OGTT) in predicting type 2 diabetes (T2DM). RESEARCH DESIGN AND METHODS Data from a 3-year, randomized, controlled, primary prevention trial among 548 Asian Indians with prediabetes were analyzed. Participants underwent OGTT with PG measurements at fasting, 30-min, and 2-h at baseline and annually until the end of the study. Multivariable Cox regression models were constructed to calculate the risk of developing diabetes based on 30-min-PG levels. Improvement in prediction performance gained by adding an elevated level of 30-min-PG over prediabetic categories was calculated using the area-under-curve (AUC), net-reclassification (NRI), and integrated discrimination improvement (IDI) statistics. RESULTS At the end of follow-up, 30.4% of individuals had been diagnosed with T2DM by ADA criteria. Based on the maximally selected log-rank statistics, the optimal 30-min-PG cut point for predicting incident T2DM was >182 mg/dl. Multivariable-adjusted Cox regression models showed an independent association between elevated 30-min-PG (>182 mg/dl) and incident diabetes (hazard ratio (95% CI): 1.85 [1.32, 2.59]; D xy  = 0.353, c-statistic = 0.676). The addition of an elevated 30-min-PG (>182 mg/dl) model significantly improved the prediction of diabetes (Δdeviance: -15.4; ΔAUC: 0.11; NRI continuous : 0.51; IDI: 0.08) compared with IFG model alone) in individuals with prediabetes. CONCLUSION In prediabetic individuals, baseline 30-min-PG independently predicted T2DM and significantly improved reclassification and discrimination. Therefore, 30-min-PG should be considered as part of the routine testing in addition to FPG and 2-h-PG for better risk stratification.",2020,"In prediabetic individuals, baseline 30-min-PG independently predicted T2DM and significantly improved reclassification and discrimination.","['548 Asian Indians with prediabetes were analyzed', 'predicting type 2 diabetes (T2DM', 'type 2 diabetes among people with prediabetes', 'individuals with prediabetes']","['30-min plasma glucose', '30-min plasma glucose (30-min-PG) measurement during an oral glucose tolerance (OGTT']","['area-under-curve (AUC), net-reclassification (NRI), and integrated discrimination improvement (IDI) statistics']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",548.0,0.0719994,"In prediabetic individuals, baseline 30-min-PG independently predicted T2DM and significantly improved reclassification and discrimination.","[{'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Division of Hospital Medicine, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: ram.jagannathan@emory.edu.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Weber', 'Affiliation': 'Emory Global Diabetes Research Center, Hubert Department of Global Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ranjit M', 'Initials': 'RM', 'LastName': 'Anjana', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ranjani', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Staimez', 'Affiliation': 'Emory Global Diabetes Research Center, Hubert Department of Global Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Emory Global Diabetes Research Center, Hubert Department of Global Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Emory Global Diabetes Research Center, Hubert Department of Global Health, Emory University, Atlanta, GA, USA.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108075'] 500,31571526,Sample size considerations for comparing dynamic treatment regimens in a sequential multiple-assignment randomized trial with a continuous longitudinal outcome.,"Clinicians and researchers alike are increasingly interested in how best to personalize interventions. A dynamic treatment regimen is a sequence of prespecified decision rules which can be used to guide the delivery of a sequence of treatments or interventions that is tailored to the changing needs of the individual. The sequential multiple-assignment randomized trial is a research tool which allows for the construction of effective dynamic treatment regimens. We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments. The formulae are derived in the context of a regression model which leverages information from a longitudinal outcome collected over the entire study. We show that the sample size formula for a sequential multiple-assignment randomized trial can be written as the product of the sample size formula for a standard two-arm randomized trial, a deflation factor that accounts for the increased statistical efficiency resulting from a longitudinal analysis, and an inflation factor that accounts for the design of a sequential multiple-assignment randomized trial. The sequential multiple-assignment randomized trial design inflation factor is typically a function of the anticipated probability of response to first-stage treatment. We review modeling and estimation for dynamic treatment regimen effect analyses using a longitudinal outcome from a sequential multiple-assignment randomized trial, as well as the estimation of standard errors. We also present estimators for the covariance matrix for a variety of common working correlation structures. Methods are motivated using the ENGAGE study, a sequential multiple-assignment randomized trial aimed at developing a dynamic treatment regimen for increasing motivation to attend treatments among alcohol- and cocaine-dependent patients.",2020,We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments.,['alcohol- and cocaine-dependent patients'],[],[],"[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}]",[],[],,0.0518145,We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments.,"[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Seewald', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Tianshuang', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McKay', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}]",Statistical methods in medical research,['10.1177/0962280219877520'] 501,32238920,Ki-67 response-guided preoperative chemotherapy for HER2-positive breast cancer: results of a randomised Phase 2 study.,"BACKGROUND The effectiveness of a therapeutic strategy that switches chemotherapy, based on Ki-67 tumour expression after initial therapy, relative to that of standard chemotherapy, has not been evaluated. METHODS Patients were randomly assigned to the control arm or the Ki-67 response-guided arm (Ki-67 arm). Primary tumour biopsies were obtained before treatment, and after three once-weekly doses of paclitaxel and trastuzumab to assess the interim Ki-67 index. In the control arm, paclitaxel and trastuzumab were continued for a total of 12 doses, regardless of the interim Ki-67 index. In the Ki-67 arm, subsequent treatment was based on the interim Ki-67 index. Ki-67 early responder is defined as the absolute Ki-67 value that was <10%, and the percentage of Ki-67-positive tumour cells was reduced by >30% compared with before treatment. Early Ki-67 responders continued to receive the same treatment, while early Ki-67 non-responders were switched to epirubicin plus cyclophosphamide. The primary endpoint was the pathological complete response (pCR) rate. RESULTS A total of 237 patients were randomised. There was almost linear correlation between the Ki-67 reduction rate at interim assessment and the pCR rate. The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). CONCLUSIONS The standard chemotherapy protocol remains as the recommended strategy for patients with HER2-positive breast cancer. CLINICAL TRIAL REGISTRATION Clinical Trial Registration: UMIN-CTR as UMIN000007074.",2020,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). ","['patients with HER2-positive breast cancer', '237 patients were randomised', 'HER2-positive breast cancer', 'Patients']","['paclitaxel and trastuzumab', 'Ki-67 response-guided preoperative chemotherapy', 'epirubicin plus cyclophosphamide', 'Ki-67 response-guided arm (Ki-67 arm']","['pathological complete response (pCR) rate', 'absolute Ki-67 value', 'pCR rate', 'Ki-67 reduction rate', 'percentage of Ki-67-positive tumour cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}]",237.0,0.0497755,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). ","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan. hrmukai@east.ncc.go.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Musashino Red Cross Hospital, Musashino, Tokyo, 180-0023, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hozumi', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba, Ibaraki, 305-8576, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Gunma Prefectural Cancer Center, Ota, Gunma, 373-0828, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, 791-0245, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Akabane', 'Affiliation': 'Asahikawa-Kosei General Hospital, Hokkaido, Asahikawa, Japan.'}, {'ForeName': 'Reiki', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Kumamoto Shinto General Hospital, Chuo Ward, Kumamoto, 862-8655, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Osaka City University Graduate School of Medicine, Sumiyoshi Ward, Osaka, 558-0022, Japan.'}, {'ForeName': 'Youngjin', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Tohoku Medical and Pharmaceutical University Hospital, Sendai, Miyagi, 981-8558, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Hakuaikai Medical Corp Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Aichi, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Imoto', 'Affiliation': 'Kyorin University Hospital, Mitaka, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Mie University Hospital, Tsu, Mie, 514-8507, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'National Cancer Center Research Institute, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Division of Pathology, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}]",British journal of cancer,['10.1038/s41416-020-0815-9'] 502,32232708,"Intracameral tissue plasminogen activator in trabeculectomy: a 1-year prospective, randomized, controlled study.","PURPOSE To evaluate the safety and the adjunctive effect of intracameral tissue plasminogen activator (tPA) in trabeculectomy for patients with primary open-angle glaucoma (POAG). METHODS This was a prospective, randomized study consisting of patients with POAG who underwent trabeculectomy in Tel Aviv Medical Center between March 2013 and December 2014. Patients were randomly assigned to two groups: Group 1 underwent mitomycin C (MMC) trabeculectomy and group 2 underwent MMC trabeculectomy with intracameral tPA. Complete and overall success were defined as intraocular pressure (IOP) between 5 and 18 mmHg and at least 30% IOP drop without and with or without anti-glaucoma treatment, respectively. RESULTS A total of 16 patients (seven females and nine males) were recruited, and eight patients were assigned to each group. IOP at presentation was 27 ± 5.3 mmHg and 25.3 ± 5.1 mmHg, compared to 13.7 ± 4.3 mmHg and 10.6 ± 2.0 at 12 months (p < 0.0001) for groups 1 and 2, respectively. Complete success at 12 months was achieved in 62.5% of group 1 compared to 87.5% of group 2 (p = 0.28). Overall success was achieved in 87% compared to 100% of patients at 12 months (p = 0.33). No evidence of complications attributable to tPA was found. CONCLUSIONS Augmentation of tPA during MMC trabeculectomy may have better complete and overall success rates, compared to MMC trabeculectomy. The safety profile was similar for both groups.",2020,Overall success was achieved in 87% compared to 100% of patients at 12 months (p = 0.33).,"['16 patients (seven females and nine males', 'trabeculectomy', 'patients with primary open-angle glaucoma (POAG', 'patients with POAG who underwent trabeculectomy in Tel Aviv Medical Center between March 2013 and December 2014']","['Intracameral tissue plasminogen activator', 'mitomycin C (MMC) trabeculectomy and group 2 underwent MMC trabeculectomy with intracameral tPA', 'intracameral tissue plasminogen activator (tPA', 'MMC trabeculectomy']","['Overall success', 'safety profile', 'intraocular pressure (IOP', 'Complete success', 'Complete and overall success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",16.0,0.0675524,Overall success was achieved in 87% compared to 100% of patients at 12 months (p = 0.33).,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Barequet', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizmann Street, 64239, Tel Aviv, Israel. danabarequet@gmail.com.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizmann Street, 64239, Tel Aviv, Israel.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Rabina', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizmann Street, 64239, Tel Aviv, Israel.'}, {'ForeName': 'Gabi', 'Initials': 'G', 'LastName': 'Shemesh', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizmann Street, 64239, Tel Aviv, Israel.'}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Kurtz', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizmann Street, 64239, Tel Aviv, Israel.'}]",International ophthalmology,['10.1007/s10792-020-01331-6'] 503,32237331,[Huangqin Qingre Chubi Capsules in improving oxidative stress of patients with ankylosing spondylitis via activating PPARγ mediated AMPK/FOXO3a pathway].,"To investigate the efficacy of Huangqin Qingre Chubi Capsules(HQC) in patients with ankylosing spondylitis(AS) and its effect on oxidative stress, and to explore its possible mechanism. Fifty-eight cases of AS patients were randomly divided into HQC group and salazosulfapyridine(SASP) group. Another 30 healthy people were employed as a control group. Superoxide dismutase(SOD), total antioxidant capacity(TAOC), malondialdehyde(MDA), lipid peroxidatio(LPO), interleukin-1β(IL-1β), IL-10, IL-4, and tumor necrosis factor-α(TNF-α) were detected by ELISA. The mRNA expression levels of AMP-activated protein kinase(AMPK-α), forkhead box O3a(FOXO3a), manganese superoxide dismutase(MnSOD), and peroxisome proliferator-activated receptor gamma(PPARγ) were detected by Real-time fluorescence quantitative polymerase chain reaction(RT-qPCR). The protein expression levels of AMPK-α, FOXO3a, p-FOXO3a, MnSOD, and PPARγ were detected by Western blot. A questionnaire was used to evaluate the disease activity score and observe the clinical efficacy of HQC in AS patients. The levels of MDA, LPO, TNF-α, and IL-1β were significantly increased in the peripheral blood of AS patients, and SOD, TAOC, IL-4, IL-10 levels were significantly decreased. After HQC treatment, scores of disease active indexes were all decreased, and its clinical efficacy was significantly higher than that in SASP group. After HQC treatment, TAOC, SOD, IL-4, IL-10 were increased and MDA, LPO, TNF-α, IL-1β were decreased; mRNA levels of AMPK-α, FOXO3a, MnSOD, PPARγ and protein levels of AMPK-α, FOXO3a, p-FOXO3a, MnSOD, PPARγ were increased(P<0.01 or P<0.05). HQC can effectively improve the clinical symptoms and oxidative stress of AS patients, and its mechanism may be related to activating PPARγ and up-regulating AMPK/FOXO3a signal pathway.",2020,"After HQC treatment, TAOC, SOD, IL-4, IL-10 were increased and MDA, LPO, TNF-α, IL-1β were decreased; mRNA levels of AMPK-α, FOXO3a, MnSOD, PPARγ and protein levels of AMPK-α, FOXO3a, p-FOXO3a, MnSOD, PPARγ were increased(P<0.01 or P<0.05).","['Another 30 healthy people', 'patients with ankylosing spondylitis', 'Fifty-eight cases of AS patients', 'patients with ankylosing spondylitis(AS']","['SASP', 'Huangqin Qingre Chubi Capsules', 'HQC', 'Huangqin Qingre Chubi Capsules(HQC', 'HQC group and salazosulfapyridine(SASP']","['protein expression levels of AMPK-α, FOXO3a, p-FOXO3a, MnSOD, and PPARγ', 'mRNA expression levels of AMP-activated protein kinase(AMPK-α), forkhead box O3a(FOXO3a), manganese superoxide dismutase(MnSOD), and peroxisome proliferator-activated receptor gamma(PPARγ', 'scores of disease active indexes', 'clinical efficacy', 'TAOC, SOD, IL-4, IL-10 were increased and MDA, LPO, TNF-α, IL-1β were decreased; mRNA levels of AMPK-α, FOXO3a, MnSOD, PPARγ and protein levels of AMPK-α, FOXO3a, p-FOXO3a, MnSOD, PPARγ', 'disease activity score', 'Superoxide dismutase(SOD), total antioxidant capacity(TAOC), malondialdehyde(MDA), lipid peroxidatio(LPO), interleukin-1β(IL-1β), IL-10, IL-4, and tumor necrosis factor-α(TNF-α', 'levels of MDA, LPO, TNF-α, and IL-1β', 'SOD, TAOC, IL-4, IL-10 levels', 'oxidative stress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}]","[{'cui': 'C1504637', 'cui_str': 'TXN protein, human'}, {'cui': 'C1025331', 'cui_str': 'Huangqin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C1333633', 'cui_str': 'FOXO3A protein, human'}, {'cui': 'C1743497', 'cui_str': 'SOD2 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C0024708', 'cui_str': 'Manganese Superoxide Dismutase'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.0174983,"After HQC treatment, TAOC, SOD, IL-4, IL-10 were increased and MDA, LPO, TNF-α, IL-1β were decreased; mRNA levels of AMPK-α, FOXO3a, MnSOD, PPARγ and protein levels of AMPK-α, FOXO3a, p-FOXO3a, MnSOD, PPARγ were increased(P<0.01 or P<0.05).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Anhui University of Traditional Chinese Medicine Hefei 230038, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology,First Affiliated Hospital, Anhui University of Traditional Chinese Medicine Hefei 230031, China.'}, {'ForeName': 'Rui-Kai', 'Initials': 'RK', 'LastName': 'Zong', 'Affiliation': 'Department of Rheumatology,First Affiliated Hospital, Anhui University of Traditional Chinese Medicine Hefei 230031, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology,First Affiliated Hospital, Anhui University of Traditional Chinese Medicine Hefei 230031, China.'}]",Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,['10.19540/j.cnki.cjcmm.20190619.501'] 504,32007523,Randomised double-masked placebo-controlled trial of the cumulative treatment efficacy profile of intense pulsed light therapy for meibomian gland dysfunction.,"PURPOSE To assess long-term cumulative treatment effects of intense pulsed light (IPL) therapy in meibomian gland dysfunction (MGD). METHODS Eighty-seven symptomatic participants (58 female, mean ± SD age, 53 ± 16 years) with clinical signs of MGD were enrolled in a prospective, double-masked, parallel-group, randomised, placebo-controlled trial. Participants were randomised to receive either four or five homogeneously sequenced light pulses or placebo treatment to both eyes, (E-Eye Intense Regulated Pulsed Light, E-Swin, France). Visual acuity, dry eye symptomology, tear film parameters, and ocular surface characteristics were assessed immediately before treatment on days 0, 15, 45, 75, and four weeks after treatment course completion on day 105. Inflammatory and goblet cell function marker expression, and eyelid swab microbiology cultures were evaluated at baseline and day 105. RESULTS Significant decreases in OSDI, SPEED, and SANDE symptomology scores, and meibomian gland capping, accompanied by increased tear film lipid layer thickness, and inhibited Corynebacterium macginleyi growth were observed in both treatment groups (all p < 0.05). Sustained clinical improvements occurred in both treatment groups from day 75, although significant changes from day 45, in lipid layer quality, meibomian gland capping, OSDI and SANDE symptomology, were limited to the five-flash group (all p < 0.05). CONCLUSIONS IPL therapy effected significant improvements in dry eye symptomology, tear film lipid layer thickness, and meibomian gland capping in MGD patients. Five-flash IPL treatment showed superior clinical efficacy to four-flash, and an initial course of at least four treatments is suggested to allow for establishment of sustained cumulative therapeutic benefits prior to evaluation of overall treatment efficacy. TRIAL REGISTRATION NUMBER ACTRN12616000667415.",2020,"Sustained clinical improvements occurred in both treatment groups from day 75, although significant changes from day 45, in lipid layer quality, meibomian gland capping, OSDI and SANDE symptomology, were limited to the five-flash group (all p<0.05). ","['Eighty-seven symptomatic participants (58 female, mean±SD age, 53±16 years) with clinical signs of MGD', 'meibomian gland dysfunction (MGD', 'meibomian gland dysfunction', 'MGD patients']","['placebo', 'intense pulsed light therapy', 'intense pulsed light (IPL) therapy']","['Inflammatory and goblet cell function marker expression, and eyelid swab microbiology cultures', 'lipid layer quality, meibomian gland capping, OSDI and SANDE symptomology', 'OSDI, SPEED, and SANDE symptomology scores, and meibomian gland capping', 'tear film lipid layer thickness, and inhibited Corynebacterium macginleyi growth', 'Visual acuity, dry eye symptomology, tear film parameters, and ocular surface characteristics', 'dry eye symptomology, tear film lipid layer thickness, and meibomian gland capping']","[{'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3494304', 'cui_str': 'Intense Pulsed Light Therapy'}]","[{'cui': 'C0506994', 'cui_str': 'Goblet Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure (procedure)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0025181', 'cui_str': 'Tarsal Glands'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1007419', 'cui_str': 'Corynebacterium macginleyi (organism)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics (attribute)'}]",87.0,0.362184,"Sustained clinical improvements occurred in both treatment groups from day 75, although significant changes from day 45, in lipid layer quality, meibomian gland capping, OSDI and SANDE symptomology, were limited to the five-flash group (all p<0.05). ","[{'ForeName': 'Ally L', 'Initials': 'AL', 'LastName': 'Xue', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ormonde', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}]",The ocular surface,['10.1016/j.jtos.2020.01.003'] 505,32234715,Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period.,"OBJECTIVE Tanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up. METHODS This double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study. RESULTS From March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference±SE -0.62±0.18, p=0.0006), WOMAC Physical Function (-0.71±0.17, p<0.0001) and PGA-OA (-0.19±0.07, p=0.0051). For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA. Rapidly progressive osteoarthritis (RPOA) was observed in 1.4% (4/283) and 2.8% (8/284) of patients in the tanezumab 2.5 mg and tanezumab 5 mg groups, respectively and none receiving placebo. Total joint replacements (TJRs) were similarly distributed across all three treatment groups (6.7%-7.8%). Tanezumab-treated patients experienced more paraesthesia (5 mg) and hypoaesthesia (both doses) than placebo. CONCLUSION Tanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups. TRIAL REGISTRATION NUMBER NCT02709486.",2020,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","['osteoarthritis of the hip or knee', 'From March 2016 to December 2017, 849 patients were randomised and evaluated ', 'phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics']","['placebo n=282, tanezumab 2.5\u2009mg n=283, tanezumab', 'placebo', 'tanezumab', 'Tanezumab', 'tanezumab 2.5 mg or 5\u2009mg subcutaneously or matching placebo', 'Subcutaneous tanezumab']","['RPOA', 'paraesthesia', 'pain, physical function and PGA-OA', 'WOMAC Physical Function', 'Rapidly progressive osteoarthritis (RPOA', 'Total joint replacements (TJRs', 'WOMAC Pain', 'Western Ontario and McMaster Universities Osteoarthritis Index', 'Joint safety and neurological assessments', 'WOMAC Pain and Physical Function', ""WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA""]","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3854438', 'cui_str': 'Rapidly progressive osteoarthritis'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",849.0,0.0446766,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Department of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hopital Saint Antoine, Paris, France francis.berenbaum@aphp.fr.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Reumatología, INIBC-Complejo Hospitalario Universitario A Coruña, La Coruña, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Faculty of Health Science, Osaka Yukioka College of Health Science, Hayaishi Hospital, Osaka, Japan.'}, {'ForeName': 'Takaharu', 'Initials': 'T', 'LastName': 'Yamabe', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Junor', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Carey', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216296'] 506,32234755,"A Randomized, Open-label, Presurgical, Window-of-Opportunity Study Comparing the Pharmacodynamic Effects of the Novel Oral SERD AZD9496 with Fulvestrant in Patients with Newly Diagnosed ER + HER2 - Primary Breast Cancer.","PURPOSE Fulvestrant, the first-in-class selective estrogen receptor (ER) degrader (SERD), is clinically effective in patients with ER + breast cancer, but it has administration and pharmacokinetic limitations. Pharmacodynamic data suggest complete ER degradation is not achieved at fulvestrant's clinically feasible dose. This presurgical study (NCT03236974) compared the pharmacodynamic effects of fulvestrant with AZD9496, a novel, orally bioavailable, nonsteroidal, potent SERD, in treatment-naïve patients with ER + HER2 - primary breast cancer awaiting curative intent surgery. PATIENTS AND METHODS Patients were randomized 1:1 to receive AZD9496 250 mg twice daily from day 1 for 5-14 days, or fulvestrant 500 mg on day 1. On-treatment imaging-guided core tumor biopsies were taken between day 5 and 14 and compared with pretreatment diagnostic biopsies. The primary objective was to compare the effects of AZD9496 and fulvestrant on ER expression. Secondary objectives included changes in progesterone receptor (PR) and Ki-67 pharmacokinetic/pharmacodynamic relationships and safety. RESULTS Forty-six women received treatment (AZD9496 n = 22; fulvestrant n = 24); 35 paired biopsies were evaluable (AZD9496 n = 15; fulvestrant n = 20). The least square mean estimate for ER H-score reduction was 24% after AZD9496 versus 36% after fulvestrant treatment ( P = 0.86). AZD9496 also reduced PR H-scores (-33.3%) and Ki-67 levels (-39.9%) from baseline, but was also not superior to fulvestrant (PR: -68.7%, P = 0.97; Ki-67: -75.4%, P = 0.98). No new safety findings were identified. CONCLUSION This was the first presurgical study to demonstrate that an oral SERD affects its key biological targets. However, AZD9496 was not superior to fulvestrant at the dose tested.",2020,"AZD9496 also reduced PR H-scores (-33.3%) and Ki‑67 levels (-39.9%) from baseline, but was also not superior to fulvestrant (PR: -68.7%, p=0.97; Ki‑67: ‑75.4%, p=0.98).","['Forty-six women received treatment (AZD9496 n=22; fulvestrant n=24); 35 paired biopsies were evaluable (AZD9496 n=15; fulvestrant n=20', 'patients with ER+ HER2- primary breast cancer', 'Patients', 'treatment‑naive patients with ER+ human epidermal growth factor receptor 2 negative primary breast cancer awaiting curative intent surgery', 'patients with ER+ breast cancer']","['fulvestrant with AZD9496', 'novel oral SERD AZD9496 with fulvestrant', 'AZD9496 250 mg twice daily from Day (D) 1 for 5-14 days, or fulvestrant 500 mg on D 1', 'AZD9496 and fulvestrant']","['PR H-scores', 'changes in progesterone receptor (PR) and Ki-67 PK/PD relationships and safety', 'Ki‑67 levels', 'ER expression', 'least square mean estimate for ER H-score reduction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4053676', 'cui_str': 'AZD9496'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C4053676', 'cui_str': 'AZD9496'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0472463,"AZD9496 also reduced PR H-scores (-33.3%) and Ki‑67 levels (-39.9%) from baseline, but was also not superior to fulvestrant (PR: -68.7%, p=0.97; Ki‑67: ‑75.4%, p=0.98).","[{'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom. john.robertson@nottingham.ac.uk.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Poole Hospital, Poole, United Kingdom.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Henschen', 'Affiliation': 'Helios Clinics Schwerin, Schwerin, Germany.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jahan', 'Affiliation': ""King's Mill Hospital, Mansfield, United Kingdom.""}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Kenny', 'Affiliation': 'Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dixon', 'Affiliation': 'Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Kothari', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mohamed', 'Affiliation': 'Johannes Wesling General Hospital, Minden, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Nuremberg, Germany.'}, {'ForeName': 'Kwok-Leung', 'Initials': 'KL', 'LastName': 'Cheung', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wuerstlein', 'Affiliation': 'Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Carroll', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Klinowska', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Justin P O', 'Initials': 'JPO', 'LastName': 'Lindemann', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mather', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Maudsley', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moschetta', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Myria', 'Initials': 'M', 'LastName': 'Nikolaou', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Martine P', 'Initials': 'MP', 'LastName': 'Roudier', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Tinnu', 'Initials': 'T', 'LastName': 'Sarvotham', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Diansong', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3387'] 507,31012225,Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial.,"BACKGROUND AND OBJECTIVE Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4% oxygen desaturation index (ODI4%) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm. METHODS This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea-hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order. RESULTS A total of 38 patients constituted the study population. Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4% across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP. CONCLUSION A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure. CLINICAL TRIAL REGISTRATION NCT02683772 at clinicaltrials.gov.",2019,Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001).,"['Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea-hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the', 'patients with chronic respiratory failure', '38 patients constituted the study population', 'patients with respiratory failure', 'Patients with chronic respiratory failure']","['Automatic EPAP intelligent volume-assured pressure support', 'AutoEPAP', 'AutoEPAP algorithm versus manual EPAP titration', 'automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm', 'iVAPS manual EPAP and iVAPS AutoEPAP', 'iVAPS with manual EPAP titration']","['Mean ODI4', 'oxygen desaturation index (ODI4%) values', 'Sleep parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264492', 'cui_str': 'Chronic respiratory failure (disorder)'}, {'cui': 'C0027868', 'cui_str': 'Neuromuscular Diseases'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3203358', 'cui_str': 'Hypoventilation'}, {'cui': 'C1314792', 'cui_str': 'Causality'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0002045'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",38.0,0.0800875,Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001).,"[{'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Department of Medicine and Neurology, Northwestern Medical Hospital, Chicago, IL, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Department of Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Krishna M', 'Initials': 'KM', 'LastName': 'Sundar', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sheila C', 'Initials': 'SC', 'LastName': 'Tsai', 'Affiliation': 'National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Adam V', 'Initials': 'AV', 'LastName': 'Benjafield', 'Affiliation': 'ResMed Science Center, San Diego, CA, USA.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Crocker', 'Affiliation': 'ResMed Science Center, San Diego, CA, USA.'}, {'ForeName': 'Leslee', 'Initials': 'L', 'LastName': 'Willes', 'Affiliation': 'Willes Consulting Group, San Diego, CA, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Lisa F', 'Initials': 'LF', 'LastName': 'Wolfe', 'Affiliation': 'Department of Medicine and Neurology, Northwestern Medical Hospital, Chicago, IL, USA.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13546'] 508,32232637,Rituximab for very low dose steroid-dependent nephrotic syndrome in children: a randomized controlled study.,"BACKGROUND Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, randomized controlled trial was designed to test whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS and how long remission may last (EudraCT:2008-004486-26). METHODS We enrolled 30 children 4-15 years who had developed SDNS 6-12 months before and were maintained in remission with low prednisone doses (0.1-0.4 mg/Kg/day). Participants were randomized following a non-inferiority design to continue prednisone alone (n 15, controls) or to add a single intravenous infusion of rituximab (375 mg/m 2 , n 15 intervention). Prednisone was tapered in both arms after 1 month. Children assigned to the control arm were allowed to receive rituximab to treat disease relapse. RESULTS Proteinuria increased at 3 months in the prednisone group (from 0.14 to 1.5 g/day) (p < 0.001) and remained unchanged in the rituximab group (0.14 g/day). Fourteen children in the control arm relapsed within 6 months. Thirteen children assigned to rituximab (87%) were still in remission at 1 year and 8 (53%) at 4 years. Responses were similar in children of the control group who received rituximab to treat disease relapse. We did not record significant adverse events. CONCLUSIONS Rituximab was non-inferior to steroids for the treatment of juvenile SDNS. One in two children remains in remission at 4 years following a single infusion of rituximab, without significant adverse events. Further studies are needed to clarify the superiority of rituximab over low-dose corticosteroid as a treatment of SDNS.",2020,"RESULTS Proteinuria increased at 3 months in the prednisone group (from 0.14 to 1.5 g/day) (p < 0.001) and remained unchanged in the rituximab group (0.14 g/day).","['Thirteen children assigned to', '30 children 4-15\xa0years who had developed SDNS 6-12\xa0months before and were maintained in remission with low prednisone doses (0.1-0.4\xa0mg/Kg/day', 'children', 'Fourteen children in the control arm relapsed within 6\xa0months']","['Prednisone', 'Rituximab', 'prednisone', 'monoclonal antibody rituximab', 'rituximab', 'continue prednisone alone (n 15, controls) or to add a single intravenous infusion of rituximab']",['Proteinuria'],"[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",13.0,0.136093,"RESULTS Proteinuria increased at 3 months in the prednisone group (from 0.14 to 1.5 g/day) (p < 0.001) and remained unchanged in the rituximab group (0.14 g/day).","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Division of Nephrology, Faculty of Medicine, Foothills Medical Centre, University of Calgary, 1403-29th Street NW, Calgary, AB, T2N 2T9, Canada. pravani@ucalgary.ca.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Lugani', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.""}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Pisani', 'Affiliation': 'Department of Medicine and Surgery, Division of Nephrology, School of Nephrology, University of Parma, Parma, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bodria', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Piaggio', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.""}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Bartolomeo', 'Affiliation': 'Department of Medicine and Surgery, Division of Nephrology, School of Nephrology, University of Parma, Parma, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Prunotto', 'Affiliation': 'School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Gian Marco', 'Initials': 'GM', 'LastName': 'Ghiggeri', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy. GMarcoGhiggeri@ospedale-gaslini.ge.it.""}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04540-4'] 509,31969366,Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.,"OBJECTIVES (1) To estimate weight change from a low-carbohydrate diabetes prevention programme (LC-DPP) and (2) to evaluate the feasibility and acceptability of an LC-DPP. RESEARCH DESIGN Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study. SETTING Primary care clinic within a large academic medical centre in the USA. PARTICIPANTS Adults with pre-diabetes and Body Mass Index of ≥25 kg/m 2 . INTERVENTION We adapted the Centers for Disease Control and Prevention's National Diabetes Prevention Program (NDPP)-an evidence-based, low-fat dietary intervention-to teach participants to follow a very low-carbohydrate diet (VLCD). Participants attended 23 group-based classes over 1 year. OUTCOME MEASURES Primary outcome measures were (1) weight change and (2) percentage of participants who achieved ≥5% wt loss. Secondary outcome measures included intervention feasibility and acceptability (eg, attendance and qualitative interview feedback). RESULTS Our enrolment target was 22. One person dropped out before a baseline weight was obtained; data from 21 individuals were analysed. Mean weight loss in kilogram was 4.3 (SD 4.8) at 6 months and 4.9 (SD 5.8) at 12 months. Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months. Mean attendance was 10.3/16 weekly sessions and 3.4/7 biweekly or monthly sessions. Among interviewees (n=14), three factors facilitated VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss. Three factors hindered VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals. CONCLUSIONS An LC-DPP is feasible, acceptable and may be an effective option to help individuals with pre-diabetes to lose weight. Data from this pilot will be used to plan a fully powered randomised controlled trial of weight loss among NDPP versus LC-DPP participants. TRIAL REGISTRATION NUMBER NCT03258918.",2020,Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months.,"['Adults with pre-diabetes and Body Mass Index of ≥25', 'Primary care clinic within a large academic medical centre in the USA', 'Participants attended 23 group-based classes over 1\u2009year', 'adults with pre-diabetes in the USA']","['low-carbohydrate diabetes prevention programme (LC-DPP', 'low-carbohydrate diabetes prevention programme', 'NDPP']","['weight change and (2) percentage of participants who achieved ≥5%\u2009wt loss', 'intervention feasibility and acceptability (eg, attendance and qualitative interview feedback', 'VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals', 'Mean weight loss in kilogram', 'Mean attendance', 'Mean per\u2009cent body weight changes', 'VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0073445', 'cui_str': 'beta-N,N-dimethyl-4-nitropropiophenone'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0453803', 'cui_str': 'High carbohydrate food (substance)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0453804', 'cui_str': 'Low carbohydrate food (substance)'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}]",21.0,0.100156,Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months.,"[{'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hafez Griauzde', 'Affiliation': 'Department of Internal Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA dhafez@med.umich.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saslow', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tahoora', 'Initials': 'T', 'LastName': 'Ansari', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Liestenfeltz', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Tisack', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Patti', 'Initials': 'P', 'LastName': 'Bihn', 'Affiliation': 'National Kidney Foundation of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Shopinski', 'Affiliation': 'National Kidney Foundation of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033397'] 510,31302525,The MARIGOLD study: Feasibility and enhancement of an online intervention to improve emotion regulation in people with elevated depressive symptoms.,"BACKGROUND This manuscript describes the first two phases of pilot testing MARIGOLD, an online self-guided positive emotion skills intervention for adults with elevated depressive symptoms, along with enhancements to overcome retention and adherence problems reported in previous research. METHODS Adults with elevated depressive symptoms were recruited online and assessed at baseline, post-intervention, 1- and 3-month follow-up. Phase 1 participants (n = 58) were randomized to MARIGOLD, daily emotion reporting, or waitlist. Phase 2 participants (n = 79) were randomized to MARIGOLD plus one enhancement: online discussion board (ODB), virtual badges (VB), or facilitator contact (FC). Post-intervention interviews assessed acceptability. Intention-to-treat analyses examined retention, adherence, and preliminary efficacy. RESULTS In both phases, retention and adherence did not differ between groups. MARIGOLD skills were highly acceptable, but qualitative results indicate web-based features (e.g., log-in, ODB, VB) require refinement prior to larger testing. Neither phase demonstrated between-group differences in preliminary efficacy. In Phase 1 within-group analyses, MARIGOLD and emotion reporting control demonstrated a similar pattern of findings (stable depressive symptoms, increased positive emotion, decreased negative emotion and stress), whereas the waitlist group significantly increased in depressive mood. Most Phase 2 within-group analyses demonstrated the expected pattern of results (i.e., decreases in PHQ-8 and negative emotion, increases in positive emotion). However, CES-D scores were stable in FC; perceived stress was stable in FC and ODB. LIMITATIONS This pilot study is not powered to evaluate efficacy. CONCLUSION Positive emotion skills, plus enhancements for web-based, self-guided delivery, warrant additional study in people with elevated depressive symptoms.",2019,"In both phases, retention and adherence did not differ between groups.","['people with elevated depressive symptoms', 'Adults with elevated depressive symptoms were recruited online and assessed at baseline, post-intervention, 1- and 3-month follow-up', 'Phase 1 participants (n\u202f=\u202f58', 'adults with elevated depressive symptoms', 'Phase 2 participants (n\u202f=\u202f79']","['online intervention', 'daily emotion reporting, or waitlist', 'plus one enhancement: online discussion board (ODB), virtual badges (VB), or facilitator contact (FC', 'online self-guided positive emotion skills intervention']","['emotion regulation', 'depressive mood', 'acceptability', 'PHQ-8 and negative emotion, increases in positive emotion', 'CES-D scores', 'retention and adherence', 'positive emotion, decreased negative emotion and stress', 'Positive emotion skills, plus enhancements for web-based, self-guided delivery']","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",,0.10412,"In both phases, retention and adherence did not differ between groups.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Addington', 'Affiliation': 'Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: elizabeth.addington@northwestern.edu.'}, {'ForeName': 'Elaine O', 'Initials': 'EO', 'LastName': 'Cheung', 'Affiliation': 'Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Bassett', 'Affiliation': 'Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kwok', 'Affiliation': 'Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Schuette', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Shiu', 'Affiliation': 'Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Dershung', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'BrightOutcome, Inc, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cohn', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Leykin', 'Affiliation': 'Palo Alto University, Palo Alto, CA, USA.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Saslow', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Osher Center for Integrative Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.049'] 511,32093647,Intervention intended to improve public health professionals' self-efficacy in their efforts to detect and manage perinatal depressive symptoms among Thai women: a mixed-methods study.,"BACKGROUND Targeting perinatal depressive symptoms among women can reduce premature mortality. However, public health professionals (PHPs) in primary healthcare settings often have low self-efficacy for detection and management of perinatal depressive symptoms among women. This mixed-methods study was aimed at developing and evaluating a self-efficacy improvement programme (SIP) intended to increase PHPs' self-efficacy in efforts to detect and manage perinatal depressive symptoms. METHODS The SIP consisted of 1 day of theory and 4 weeks of practice. Sixty-six PHPs from sub-district health promotion hospitals (primary health care level) in Sakonnakhon, a north-eastern province in Thailand, were randomised into an intervention group (n = 33) and a control group (n = 33). Twenty-three of the intervention group participants also took part in focus group discussions (FGDs). Multiple linear regression and qualitative content analysis were used to analyse the data. RESULTS After the SIP, the intervention group participants had higher self-efficacy score than those in the control group (p = 0.004). The FGDs resulted in four categories emerging: Having confidence, Changing knowledge and attitudes, Increasing perception of an important role, and Increasing awareness of performed function. CONCLUSIONS To enhance the ability of PHPs to detect and manage perinatal depressive symptoms, an intervention programme based on self-efficacy modification is recommended.",2020,"After the SIP, the intervention group participants had higher self-efficacy score than those in the control group (p = 0.004).","['Sixty-six PHPs from sub-district health promotion hospitals (primary health care level) in Sakonnakhon, a north-eastern province in Thailand', 'Thai women']",[],['higher self-efficacy score'],"[{'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0305026,"After the SIP, the intervention group participants had higher self-efficacy score than those in the control group (p = 0.004).","[{'ForeName': 'Nitikorn', 'Initials': 'N', 'LastName': 'Phoosuwan', 'Affiliation': 'Department of Public Health and Caring Sciences, Faculty of Medicine, Uppsala University, BMC, Husargatan 3, Box 564, 751 22, Uppsala, Sweden. nitikorn.phoosuwan@pubcare.uu.se.'}, {'ForeName': 'Pranee C', 'Initials': 'PC', 'LastName': 'Lundberg', 'Affiliation': 'Department of Public Health and Caring Sciences, Faculty of Medicine, Uppsala University, BMC, Husargatan 3, Box 564, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Sadiporn', 'Initials': 'S', 'LastName': 'Phuthomdee', 'Affiliation': 'Panyananthaphikkhu Chonprathan Medical Centre, Srinakarinwirot University, Nonthaburi, Thailand.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Eriksson', 'Affiliation': 'Department of Public Health and Caring Sciences, Faculty of Medicine, Uppsala University, BMC, Husargatan 3, Box 564, 751 22, Uppsala, Sweden.'}]",BMC health services research,['10.1186/s12913-020-5007-z'] 512,30855082,Cost of behavioral weight loss programs implemented in clinical practice: The POWER trial at Johns Hopkins.,"Obesity presents an important public health problem that affects more than a third of the U.S. adult population and that is associated with increased morbidity, mortality, and costs. Previously, we documented that two primary care-based weight loss interventions were clinically effective. To encourage the implementation of and reimbursement for these interventions, we evaluated their relative cost-effectiveness. We performed a cost analysis of the Practice-based Opportunities for Weight Reduction (POWER) trial, a three-arm trial that enrolled 415 patients with obesity from six primary care practices. Trial participants were randomized to a control arm, an in-person support intervention, or a remote support intervention; in the two intervention arms, behavioral interventions were delivered over 24 months, in two phases. Weight loss was measured at 6, 12, and 24 months. Using timesheets and empirical data, we evaluated the cost of the in-person and remote support interventions from the perspective of a health care system delivering the interventions. A univariate sensitivity analysis was conducted to evaluate uncertainty around model assumptions. All comparisons were tested using independent t-tests. Cost of the in-person intervention was higher at 6 months ($113 per participant per month and $117 per kg lost) than the remote support intervention ($101 per participant per month and $99 per kg lost; p < .001). Costs were also higher for the in-person support intervention at 24 months ($73 per participant per month and $342 per kg lost) than for the remote support intervention ($53 per participant per month and $275 per kg lost; p < .001). In the sensitivity analyses, cost ranged from $274/kg lost to $456/kg lost for the in-person support intervention and from $218/kg to $367/kg lost for the remote support intervention. A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention. Expanding the scope of reimbursable programs to include other cost-effective interventions could help ensure that a broader range of patients receive the type of support needed.",2020,A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention.,['enrolled 415 patients with obesity from six primary care practices'],"['person support intervention, or a remote support intervention']","['Weight loss', 'morbidity, mortality, and costs', 'Costs', 'Cost of the in-person intervention', 'cost-effective']","[{'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",415.0,0.0839127,A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention.,"[{'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nowella', 'Initials': 'N', 'LastName': 'Durkin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Louis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Frick', 'Affiliation': 'Johns Hopkins Carey Business School, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby120'] 513,32054791,Bladder training for urinary tract symptoms in Parkinson disease: A randomized controlled trial.,"OBJECTIVE To assess the feasibility and efficacy of bladder training for troublesome lower urinary tract symptoms (LUTS) in Parkinson disease (PD). METHODS In this single-center, single-blinded, randomized controlled trial, participants with a history of PD and LUTS were randomized to a 12-week bladder training program (BT) or conservative advice (CA). Outcome measures included a 3-day volume frequency diary, International Consultation on Incontinence Questionnaire (ICIQ)-Overactive Bladder Module, and ICIQ-Quality of Life Module. Co-primary endpoints were (1) patient perception of change and (2) change in number of urgency episodes at 12 weeks. Secondary endpoints included change in ICIQ scores, number of micturitions, and volume voided. RESULTS Thirty-eight participants were randomized (18 to CA, 20 to BT). Both CA and BT were associated with significant improvements in volume voided, number of micturitions, symptom severity scores, and measures of quality of life (all p < 0.05). At 12 weeks, compared to CA, BT was associated with significant superiority on patient perception of improvement ( p = 0.001), significantly greater reductions in number of voids in 24 hours (mean decrease 2.3 ± 0.8 voids vs 0.3 ± 0.5 [ p < 0.05]), and greater reductions in interference with daily life (2.1 ± 0.8 point improvement vs 0.3 ± 0.7 point deterioration [ p < 0.05]). BT was not associated with change in urgency episodes (mean change 2.4 ± 1.5 urgency episodes vs 3.5 ± 1.5 [ p NS]). At 20 weeks, BT remained associated with greater improvement in interference in daily life. Loss of significance in other measures may reflect loss of power from loss to follow-up. CONCLUSION This controlled trial demonstrated the potential benefits of BT for LUTS in PD. CLASSIFICATION OF EVIDENCE This study provides Class III evidence that for patients with PD and LUTS, BT significantly increased patient perception of improvement but did not significantly reduce urgency episodes.",2020,"Both CA and BT were associated with significant improvements in volume voided, number of micturitions, symptom severity scores, and measures of quality of life (all p < 0.05).","['Parkinson disease (PD', 'participants with a history of PD and LUTS', 'urinary tract symptoms in PD']","['bladder training program (BT) or conservative advice (CA', 'Bladder training', 'bladder training']","['number of voids', 'patient perception of improvement', 'change in ICIQ scores, number of micturitions, and volume voided', 'interference with daily life', 'patient perception of change and (2) change in number of urgency episodes', 'volume voided, number of micturitions, symptom severity scores, and measures of quality of life', 'interference in daily life', 'urgency episodes', '3-day volume frequency diary, International Consultation on Incontinence Questionnaire (ICIQ)-Overactive Bladder Module, and ICIQ-Quality of Life Module']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042027'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire (assessment scale)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]",38.0,0.229963,"Both CA and BT were associated with significant improvements in volume voided, number of micturitions, symptom severity scores, and measures of quality of life (all p < 0.05).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'From Gateshead Health (C.M.) and Newcastle Upon Tyne Hospitals (J.R., J.L.N.), NHS Foundation Trust; Faculty of Medical Sciences (C.M., J.L.N., D.J.B.), Newcastle University, UK; and Zealand University Hospital (K.W.), Roskilde, Denmark. claire.mcdonald@ncl.ac.uk.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'From Gateshead Health (C.M.) and Newcastle Upon Tyne Hospitals (J.R., J.L.N.), NHS Foundation Trust; Faculty of Medical Sciences (C.M., J.L.N., D.J.B.), Newcastle University, UK; and Zealand University Hospital (K.W.), Roskilde, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Winge', 'Affiliation': 'From Gateshead Health (C.M.) and Newcastle Upon Tyne Hospitals (J.R., J.L.N.), NHS Foundation Trust; Faculty of Medical Sciences (C.M., J.L.N., D.J.B.), Newcastle University, UK; and Zealand University Hospital (K.W.), Roskilde, Denmark.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Newton', 'Affiliation': 'From Gateshead Health (C.M.) and Newcastle Upon Tyne Hospitals (J.R., J.L.N.), NHS Foundation Trust; Faculty of Medical Sciences (C.M., J.L.N., D.J.B.), Newcastle University, UK; and Zealand University Hospital (K.W.), Roskilde, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Burn', 'Affiliation': 'From Gateshead Health (C.M.) and Newcastle Upon Tyne Hospitals (J.R., J.L.N.), NHS Foundation Trust; Faculty of Medical Sciences (C.M., J.L.N., D.J.B.), Newcastle University, UK; and Zealand University Hospital (K.W.), Roskilde, Denmark.'}]",Neurology,['10.1212/WNL.0000000000008931'] 514,32209650,Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2.,"OBJECTIVE To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of chronic migraine (CM). METHODS The Prevention of Migraine via Intravenous ALD403 Safety and Efficacy-2 (PROMISE-2) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with CM were randomly assigned to receive IV eptinezumab 100 mg, eptinezumab 300 mg, or placebo administered on day 0 and week 12. The primary endpoint was change from baseline in mean monthly migraine days (MMDs) over weeks 1 to 12. RESULTS Among treated participants (n = 1,072), baseline mean number of MMDs was ≈16.1 across groups. Treatment with eptinezumab 100 and 300 mg was associated with significant reductions in MMDs across weeks 1 to 12 compared with placebo (placebo -5.6, 100 mg -7.7, p < 0.0001 vs placebo; 300 mg -8.2, p < 0.0001 vs placebo). Treatment-emergent adverse events (TEAEs) were reported by 43.5% (100 mg), 52.0% (300 mg), and 46.7% (placebo) of patients. Nasopharyngitis was the only TEAE reported for >2% of eptinezumab-treated patients at an incidence of >2% over placebo; it occurred in the 300 mg eptinezumab arm (eptinezumab 9.4%, placebo 6.0%). CONCLUSION In patients with CM, eptinezumab 100 and 300 mg was associated with a significant reduction in MMDs from the day after IV administration through week 12, was well tolerated, and demonstrated an acceptable safety profile. CLASSIFICATION OF EVIDENCE This study provides Class I evidence that for patients with CM, a single dose of eptinezumab reduces MMDs over 12 weeks of treatment. CLINICALTRIALSGOV IDENTIFIER NCT02974153.",2020,"Treatment with eptinezumab 100 and 300 mg was associated with significant reductions in MMDs across weeks 1 to 12 compared with placebo (placebo -5.6, 100 mg -7.7, p < 0.0001 vs placebo; 300 mg -8.2, p < 0.0001 vs placebo).","['patients with CM', 'chronic migraine (CM', 'Adults with CM', 'patients with chronic migraine']","['IV eptinezumab 100 mg, eptinezumab 300 mg, or placebo', 'eptinezumab', 'placebo (placebo', 'placebo']","['Efficacy and safety', 'mean monthly migraine days (MMDs', 'baseline mean number of MMDs', 'acceptable safety profile', 'MMDs', 'Nasopharyngitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",1072.0,0.62084,"Treatment with eptinezumab 100 and 300 mg was associated with significant reductions in MMDs across weeks 1 to 12 compared with placebo (placebo -5.6, 100 mg -7.7, p < 0.0001 vs placebo; 300 mg -8.2, p < 0.0001 vs placebo).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ. richard.lipton@einsteinmed.org.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Schaeffler', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Biondi', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pederson', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Allan', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': ""From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ.""}]",Neurology,['10.1212/WNL.0000000000009169'] 515,31558501,Cerebral Venous Thrombosis: MR Black-Blood Thrombus Imaging with Enhanced Blood Signal Suppression.,"BACKGROUND AND PURPOSE The residual blood flow artifact is a critical confounder for MR black-blood thrombus imaging of cerebral venous sinus thrombosis. This study aimed to conduct a validation of a new MR black-blood thrombus imaging technique with enhanced blood signal suppression. MATERIALS AND METHODS Twenty-six participants (13 volunteers and 13 patients) underwent conventional imaging methods followed by 2 randomized black-blood thrombus imaging scans, with a preoptimized delay alternating with nutation for tailored excitation (DANTE) preparation switched on and off, respectively. The signal intensity of residual blood, thrombus, brain parenchyma, normal lumen, and noise on black-blood thrombus images were measured. The thrombus volume, SNR of residual blood, and contrast-to-noise ratio for residual blood versus normal lumen, thrombus versus residual blood, and brain parenchyma versus normal lumen were compared between the 2 black-blood thrombus imaging techniques. Segmental diagnosis of venous sinus thrombosis was evaluated for each black-blood thrombus imaging technique using a combination of conventional imaging techniques as a reference. RESULTS In the volunteer group, the SNR of residual blood (11.3 ± 2.9 versus 54.0 ± 23.4, P < .001) and residual blood-to-normal lumen contrast-to-noise ratio (7.5 ± 3.4 versus 49.2 ± 23.3, P < .001) were significantly reduced using the DANTE preparation. In the patient group, the SNR of residual blood (16.4 ± 8.0 versus 75.0 ± 35.1, P = .002) and residual blood-to-normal lumen contrast-to-noise ratio (12.4 ± 7.8 versus 68.8 ± 35.4, P = .002) were also significantly lower on DANTE-prepared black-blood thrombus imaging. The new black-blood thrombus imaging technique provided higher thrombus-to-residual blood contrast-to-noise ratio, significantly lower thrombus volume, and substantially improved diagnostic specificity and agreement with conventional imaging methods. CONCLUSIONS DANTE-prepared black-blood thrombus imaging is a reliable MR imaging technique for diagnosing cerebral venous sinus thrombosis.",2019,"Segmental diagnosis of venous sinus thrombosis was evaluated for each black-blood thrombus imaging technique using a combination of conventional imaging techniques as a reference. ",['Twenty-six participants (13 volunteers and 13 patients) underwent'],"['conventional imaging methods followed by 2 randomized black-blood thrombus imaging scans, with a preoptimized delay alternating with nutation for tailored excitation (DANTE) preparation']","['thrombus volume, SNR of residual blood, and contrast-to-noise ratio for residual blood versus normal lumen, thrombus versus residual blood, and brain parenchyma versus normal lumen', 'Segmental diagnosis of venous sinus thrombosis', 'residual blood-to-normal lumen contrast-to-noise ratio', 'signal intensity of residual blood, thrombus, brain parenchyma, normal lumen, and noise on black-blood thrombus images', 'SNR of residual blood']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441633'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1562171', 'cui_str': 'Segmental diagnosis'}, {'cui': 'C0226504', 'cui_str': 'Structure of venous sinus'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",26.0,0.0156739,"Segmental diagnosis of venous sinus thrombosis was evaluated for each black-blood thrombus imaging technique using a combination of conventional imaging techniques as a reference. ","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Radiology (X.Y., Q.Y.) Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Departments of Emergency (J.D., X.J.).'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Paul C. Lauterbur Research Center for Biomedical Imaging (N.Z.), Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, China.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Maya', 'Affiliation': 'Department of Imaging (M.M.M.), Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Bi', 'Affiliation': 'MR R&D (X.B., D.L.), Siemens Healthineers, Los Angeles, California.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Departments of Emergency (J.D., X.J.).'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute Zhaoyang.Fan@csmc.edu yangyangqiqi@gmail.com.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'From the Department of Biomedical Sciences (G.W., N.Z., Y.X., D.L., Q.Y., Z.F.), Biomedical Imaging Research Institute Zhaoyang.Fan@csmc.edu yangyangqiqi@gmail.com.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6212'] 516,30302744,Processes of Change for Colonoscopy: Limited Support for Use Among Navigated Latinos.,"This study assessed the role of the processes of change (POC), a construct of the transtheoretical model, in colorectal cancer (CRC) screening among Latinos. Latinos participate in CRC screening less often and are diagnosed with CRC at a later stage than whites. POC items were administered to 344 English- and Spanish-speaking Latinos at average risk for CRC who had not had a colonoscopy in the past 5 years and received a colonoscopy referral. POC were measured at three timepoints: following informed consent (T1) at time of referral, 2 weeks prior to scheduled colonoscopy (T2), and 1 month after scheduled colonoscopy (T3). Participants received patient navigation as part of a randomized controlled trial to promote screening colonoscopy. POC scores were examined for changes during the course of the intervention, and logistic regression models assessed the relationship between POC scores and CRC screening adherence. Total POC scores decreased between T1 and T2 (p = 0.03) but were unchanged between T1 and T3. CRC screening adherence was not significantly associated with POC scores or change in POC scores over time. The POC instrument was not found useful for predicting colonoscopy adherence among Latinos in conjunction with patient navigation. Total POC scores did not increase during a patient navigation intervention despite high colonoscopy completion rates.",2019,Total POC scores decreased between T1 and T2 (p = 0.03) but were unchanged between T1 and T3.,['colorectal cancer (CRC) screening among Latinos'],['patient navigation'],"['POC scores', 'Total POC scores', 'POC scores and CRC screening adherence', 'CRC screening adherence', 'POC', 'colonoscopy adherence', 'POC scores or change in POC scores']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0292842,Total POC scores decreased between T1 and T2 (p = 0.03) but were unchanged between T1 and T3.,"[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10029, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'DuHamel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, 10022, USA. duhamelk@mskcc.org.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, 10022, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jandorf', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY, 10029, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-018-0528-4'] 517,32149566,Gonadal hormones may predict structural bone fragility in elite female soccer player.,"Purpose : This study determined the impact of menstrual status on bone tissue in elite post-pubertal female soccer players over an entire season. Methods : Fifty-one elite female soccer players participated. At baseline, forty-one were assigned to the low hormonal androgenic profile (low-HAPL) and 10 to the high hormonal androgenic profile (high-HAPL). Results : An 8-month training program led to increased bone mineral density content (p<0.05). The low-HAPL athletes improved the Narrow neck average cortical thickness (ACT) by 1.4% and reduced the corresponding Buckling ratio (BR) by 2.6%, thus decreasing the fracture risk (p<0.05). The high-HAPL athletes decreased the Narrow neck ACT by 5.4% and increased the BR by 2.6%, increasing fracture risk (p<0.05). Differences were assigned as being ""very likely beneficial"" for the low-HAPL athletes, supported by very large (d=3.41) and large (d=1.58) effect sizes for the Narrow neck ACT and BR, respectively. Conclusion : A season of soccer training has induced bone geometry improvements in adolescent females. Bone health parameters improved in the two clusters. However, high-HAPL athletes decreased its resistance to loading compare to low-HAPL athletes. Even if female players do not present clinical symptoms related to their hormonal status, sport medicine physicians should pay attention to their structural bone fragility.",2020,An 8-month training program led to increased bone mineral density content (p<0.05).,"['female players', 'elite post-pubertal female soccer players', 'Fifty-one elite female soccer players participated', 'adolescent females', 'elite female soccer player']",[],"['bone mineral density content', 'Narrow neck ACT', 'Bone health parameters', 'Narrow neck average cortical thickness (ACT', 'corresponding Buckling ratio (BR']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1626404', 'cui_str': 'Post-pubertal'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231748', 'cui_str': 'Giving-way (finding)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0164342,An 8-month training program led to increased bone mineral density content (p<0.05).,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lanhers', 'Affiliation': 'Sport Medicine and Functional Explorations, University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Courteix', 'Affiliation': 'Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions (AME2P), University Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Valente-Dos-Santos', 'Affiliation': 'Research Unity for Sport and Physical Activity (CIDAF, UID/DTP/04213/2016), University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Ferry', 'Affiliation': 'I3MTO, University of Orléans, Orléans, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Gracia-Marco', 'Affiliation': 'Growth, Exercise, NUtrition and Development (GENUD) Research Group, Universidad De Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Department of Clinical Research and Innovation (DRCI), University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France.'}, {'ForeName': 'Ileana Monica', 'Initials': 'IM', 'LastName': 'Borda', 'Affiliation': 'Clinical Rehabilitation Hospital, University of Medicine and Pharmacy ""Luliu Hatieganu"", Cluj-Napoca, Romania.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'I3MTO, University of Orléans, Orléans, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Sport Medicine and Functional Explorations, University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France.'}]",Journal of sports sciences,['10.1080/02640414.2020.1735982'] 518,32120198,Electronic screening and brief intervention to reduce cannabis use and consequences among graduate students presenting to a student health center: A pilot study.,"This pilot study sought to test the feasibility of screening and delivering a web-based intervention to reduce marijuana use and consequences among graduate student presenting to a Student Health Center (SHC). Graduate students completed a 9-item electronic health screening instrument during their visit to the SHC. Those who reported monthly or greater marijuana use were eligible for participation in the pilot trial. Forty-nine students completed baseline assessments and were randomly assigned to an electronic screening and brief intervention (eSBI) for marijuana (eCHECKUPTOGO-marijuana; [BI]) or a control condition (CTL) that consisted of minimal general health information. Participants completed measures of marijuana use frequency and negative consequences at baseline, 3- and 6-months. Latent growth modeling was used to provide effect size estimates for the influence of the intervention on 6-month outcomes. Effect size estimates showed a small-to-medium effect of BI on marijuana use frequency at 6-months; there was no evidence of the BI on consequences. Results suggest that BI may hold promise as a method to reduce marijuana use among graduate students who present to primary care settings. Future research should test the efficacy of this approach in a full-scale randomized controlled trial.",2020,This pilot study sought to test the feasibility of screening and delivering a web-based intervention to reduce marijuana use and consequences among graduate student presenting to a Student Health Center (SHC).,"['graduate student presenting to a Student Health Center (SHC', 'graduate students who present to primary care settings', 'Forty-nine students completed baseline assessments', 'Those who reported monthly or greater marijuana use were eligible for participation in the pilot trial', 'Graduate students', 'graduate students presenting to a student health center']","['electronic screening and brief intervention (eSBI) for marijuana (eCHECKUPTOGO-marijuana; [BI]) or a control condition (CTL', 'screening and delivering a web-based intervention', 'Electronic screening and brief intervention']",[],"[{'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4316909', 'cui_str': 'Marijuana Use'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],49.0,0.0411981,This pilot study sought to test the feasibility of screening and delivering a web-based intervention to reduce marijuana use and consequences among graduate student presenting to a Student Health Center (SHC).,"[{'ForeName': 'Tracie M', 'Initials': 'TM', 'LastName': 'Goodness', 'Affiliation': 'Department of Psychology, Boston University, 900 Commonwealth Ave., Boston, MA 02215, United States. Electronic address: tgoodnes@bu.edu.'}, {'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychology, Boston University, 900 Commonwealth Ave., Boston, MA 02215, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106362'] 519,32122273,The effect of carbohydrate and caffeine mouth rinsing on kicking performance in competitive Taekwondo athletes during Ramadan.,"Mouth rinsing has been proposed as a strategy to minimize performance decrements during Ramadan. We investigated the effect of 4 weeks of Ramadan on kicking performance in 27 Taekwondo athletes performing weekly Taekwondo Anaerobic Intermittent Kick Tests (TAIKT). The effects of a placebo, 6.4% glucose and 6-mg/kg caffeine mouth rinses on TAIKT performance and perceived exertion were investigated before, during weekly training sessions, and after Ramadan in a counterbalanced, crossover design. Ramadan had a significant negative impact on the percentage of successful kicks in Week 1 of Ramadan (pre: 76.7±0.4%, Week 1: 69.9±3.2%). The percentage of successful kicks was significantly greater in the caffeine mouth rinse condition compared to the glucose and placebo conditions during the first 3 weeks of Ramadan (caffeine: 38.3±6.8%, glucose: 36.4±6.9%, placebo: 36.0±6.5%). Caffeine decreased perceived exertion during Ramadan (0.74-1.15 AU, p>0.05). Our results showed that Ramadan had a significant negative effect on repeated high-intensity kicking efforts that should be considered when training and competing. Additionally, there were significant positive effects of a caffeine mouth rinse in a sport-specific test. These data suggest that athletes can consider mouth rinsing as a strategy to enhance performance when undertaking training or competition during a period of privation.",2020,"The percentage of successful kicks was significantly greater in the caffeine mouth rinse condition compared to the glucose and placebo conditions during the first 3 weeks of Ramadan (caffeine: 38.3±6.8%, glucose: 36.4±6.9%, placebo: 36.0±6.5%).","['27 Taekwondo athletes performing weekly', 'competitive Taekwondo athletes during Ramadan']","['caffeine mouth rinse', 'placebo', 'placebo, 6.4% glucose and 6-mg/kg caffeine mouth rinses', 'Caffeine', 'Ramadan', 'carbohydrate and caffeine mouth rinsing', 'Taekwondo Anaerobic Intermittent Kick Tests (TAIKT']","['TAIKT performance and perceived exertion', 'percentage of successful kicks', 'kicking performance']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",27.0,0.0755378,"The percentage of successful kicks was significantly greater in the caffeine mouth rinse condition compared to the glucose and placebo conditions during the first 3 weeks of Ramadan (caffeine: 38.3±6.8%, glucose: 36.4±6.9%, placebo: 36.0±6.5%).","[{'ForeName': 'İbrahim Ethem', 'Initials': 'İE', 'LastName': 'Pak', 'Affiliation': 'Physical Education and Sports Department, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Cuğ', 'Affiliation': 'Faculty of Sport Sciences, Kocaeli University, Izmit, Turkey.'}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': 'Volpe', 'Affiliation': 'Nutrition Sciences Department, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'C Martyn', 'Initials': 'CM', 'LastName': 'Beaven', 'Affiliation': 'School of Health, University of Waikato, Tauranga, New Zealand.'}]",Journal of sports sciences,['10.1080/02640414.2020.1735033'] 520,32126528,Alpha down-regulation neurofeedback training effects on implicit motor learning and consolidation.,"OBJECTIVE Implicit motor learning, which is a non-conscious form of learning characterized by motor performance improvement with practice, plays an essential role in various daily activities. Earlier study using neurofeedback training (NFT), a type of brain-computer interaction that enables the user to learn self-regulating his/her own brain activity, demonstrated that down-regulating alpha over primary motor cortex by NFT could immediately facilitate the implicit motor learning in a relatively simple motor task. However, detailed effects on EEG and implicit motor learning due to NFT especially in a more complex motor task are still unclear. APPROACH We designed a single-blind sham-controlled between-subject study to examine whether alpha down-regulation NFT could facilitate implicit motor learning and also its consolidation in a more difficult and motor predominant task. At left primary motor cortex (C3) in two days, the alpha NFT group received alpha down-regulation training through auditory feedback while the sham-control group received random beta NFT. At the end of NFT, all participants performed the continuous tracking task with their dominant (right) hand to evaluate the implicit motor learning immediately. Finally, the continuous tracking task was performed again on the next day to assess consolidation effects. MAIN RESULTS The alpha NFT group successfully decreased alpha amplitude during NFT, whereas the sham-control group maintained alpha at a relatively stable level. There was unfortunately no statistical evidence proving that the alpha NFT group significantly enhanced the implicit motor learning at the end of NFT and the consolidation on the next day compared to the sham-control group. Nevertheless, a significant correlation was found between the alpha change trend during NFT and the implicit motor learning for all participants, suggesting that faster alpha down-regulation was associated with better implicit motor learning. SIGNIFICANCE The findings suggested a close link between implicit motor learning and alpha change induced by NFT.",2020,"Nevertheless, a significant correlation was found between the alpha change trend during NFT and the implicit motor learning for all participants, suggesting that faster alpha down-regulation was associated with better implicit motor learning. ",[],"['alpha down-regulation training through auditory feedback while the sham-control group received random beta NFT', 'neurofeedback training (NFT', 'alpha down-regulation NFT', 'alpha NFT', 'NFT']","['alpha amplitude', 'implicit motor learning']",[],"[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.021224,"Nevertheless, a significant correlation was found between the alpha change trend during NFT and the implicit motor learning for all participants, suggesting that faster alpha down-regulation was associated with better implicit motor learning. ","[{'ForeName': 'Wenya', 'Initials': 'W', 'LastName': 'Nan', 'Affiliation': ""Department of Psychology, Shanghai Normal University, Shanghai, People's Republic of China. Department of Electrical and Computer Engineering, University of Macau, Macau. Centre for Cognitive and Brain Sciences, Institute of Collaborative Innovation, University of Macau, Macau.""}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ''}]",Journal of neural engineering,['10.1088/1741-2552/ab7c1b'] 521,31004346,"First-in-man study of ACT-709478, a novel selective triple T-type calcium channel blocker.","OBJECTIVE Increased activity of T-type Ca 2+ channels is linked to idiopathic generalized epilepsies, thus blocking these channels may be a new treatment option. ACT-709478 is an orally available triple T-type Ca 2+ channel blocker. The aim of this first-in-man study was to investigate the pharmacokinetics, pharmacodynamics, tolerability, and safety of single doses of ACT-709478 in healthy subjects. METHODS This double-blind, placebo-controlled, randomized study included 65 healthy male subjects. Ascending single oral doses of 1-400 mg ACT-709478 or placebo were administered to sequential groups of eight subjects (6 on active, 2 on placebo). Effect of food was tested in a crossover part at 60 mg. Blood and saliva sampling for pharmacokinetic evaluations and safety assessments was performed regularly. Effects on the central nervous system were assessed with a battery of pharmacodynamic tests. RESULTS The maximum plasma concentration (C max ) was reached within 3 to 4 hours (≤60 mg) and within 20 to 28 hours (>60 mg), and across all dose levels the terminal half-life (95% confidence interval) ranged from 36 (29-45) to 43 (22-86) hours. Multiple peaks were observed and C max and area under the plasma concentration-time curve (AUC) 0-∞ increased in a less than dose-proportional manner. A 1.6-fold increase in C max and no change in AUC 0-∞ was observed in fed compared to fasted conditions. A significant correlation (P < 0.0001) between plasma and saliva concentrations was established using linear regression. All adverse events were transient and of mild or moderate intensity. No treatment-related effects on vital signs, clinical laboratory, telemetry, or electrocardiography were detected. The results of pharmacodynamic tests did not show relevant mean changes compared to baseline or placebo. SIGNIFICANCE ACT-709478 exhibits good tolerability and safety after single-dose administration and its pharmacokinetic and pharmacodynamic properties warrant further investigations.",2019,"No treatment-related effects on vital signs, clinical laboratory, telemetry, or electrocardiography were detected.","['65 healthy male subjects', 'healthy subjects']",['placebo'],"['pharmacokinetics, pharmacodynamics, tolerability, and safety', 'maximum plasma concentration (C max ', 'C max and no change in AUC 0-∞', 'C max and area under the plasma concentration-time curve (AUC', 'vital signs, clinical laboratory, telemetry, or electrocardiography', 'plasma and saliva concentrations']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}]",65.0,0.210585,"No treatment-related effects on vital signs, clinical laboratory, telemetry, or electrocardiography were detected.","[{'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Richard', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Kornberger', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Epilepsia,['10.1111/epi.14732'] 522,32229033,Impact of head of bed elevation in symptoms of patients with gastroesophageal reflux disease: a randomized single-blind study (IBELGA).,"BACKGROUND The clinical impact of head-of-bed elevation in patients with gastro-oesophageal reflux disease is unclear, because of inconsistency and methodological limitations of previous studies. PATIENTS AND METHODS A randomised single-blind single-centre controlled clinical trial with a 2x2 cross-over design, in 39 pharmacologically treated patients with gastro-oesophageal reflux disease. Active intervention was to use a head-of-bed-elevation of 20cm for 6 weeks and then to sleep without inclination for 6 additional weeks, with a wash-out of 2 weeks between periods. The primary outcome was a change ≥10% in RDQ score and secondary outcomes were a change ≥10% in SF-36 score, patient preference and frequency of adverse events. RESULTS 27 (69.2%) patients who used the intervention reached the primary outcome vs 13 (33.3%) patients in the control group (RR: 2.08; 95 CI%: 1.19 - 3.61). No effect was found in SF-36 score (RR: 1.11; 95% CI: 0.47 - 2.60). Preference favouring the intervention was 77.1% and adverse event proportion was 54.0%. CONCLUSION Head-of-bed elevation improved reflux symptoms but there was no effect on quality of life. The finding of a non-optimal risk-benefit ratio warrants additional studies before this intervention can be recommended (IBELGA, ClinicalTrials.gov identifier NCT02706938).",2020,No effect was found in SF-36 score (RR: 1.11; 95% CI: 0.47 - 2.60).,"['patients with gastroesophageal reflux disease', 'patients with gastro-oesophageal reflux disease', '39 pharmacologically treated patients with gastro-oesophageal reflux disease']",[],"['SF-36 score, patient preference and frequency of adverse events', 'quality of life', 'change ≥10% in RDQ score and secondary outcomes', 'reflux symptoms', 'SF-36 score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.171151,No effect was found in SF-36 score (RR: 1.11; 95% CI: 0.47 - 2.60).,"[{'ForeName': 'Iván Mauricio', 'Initials': 'IM', 'LastName': 'Villamil Morales', 'Affiliation': 'Departamento de Medicina Interna, Universidad Nacional de Colombia, Bogotá, Colombia.'}, {'ForeName': 'Daniel Mauricio', 'Initials': 'DM', 'LastName': 'Gallego Ospina', 'Affiliation': 'Departamento de Medicina Interna, Universidad Nacional de Colombia, Bogotá, Colombia.'}, {'ForeName': 'William Alberto', 'Initials': 'WA', 'LastName': 'Otero Regino', 'Affiliation': 'Departamento de Medicina Interna, Universidad Nacional de Colombia, Bogotá, Colombia; Programa de gastroenterología, Universidad Nacional de Colombia, Bogotá, Colombia. Electronic address: waoteror@gmail.com.'}]",Gastroenterologia y hepatologia,['10.1016/j.gastrohep.2020.01.007'] 523,30485516,Two for one? Effects of a couples intervention on partners of persons with Type 2 diabetes: a randomized controlled trial.,"AIMS To compare the outcomes of partners who participated in a telephone couples behavioural intervention to improve glycaemic control in persons with Type 2 diabetes with those of untreated partners of participants in an individual intervention or education; to explore 'ripple effects', i.e. positive behaviour changes seen in untreated partners. METHODS The Diabetes Support Project was a three-arm randomized telephone intervention trial comparing outcomes of couples calls (CC), individual calls (IC) and diabetes education calls (DE). Couples included one partner with Type 2 diabetes and HbA 1c ≥ 58 mmol/mol (7.5%). All arms received self-management education (two calls). CC and IC arms participated in 10 additional behaviour change calls. CC included partners, emphasizing partner communication, collaboration and support. Blinded assessments were performed at 4, 8 and 12 months. Partner outcomes were psychosocial (diabetes distress, relationship satisfaction, depressive symptoms), medical (BMI, blood pressure) and behavioural (fat intake, activity). RESULTS Partners' (N = 268) mean age was 55.8 years, 64.6% were female and 29.9% were from minority ethnic groups. CC (vs. IC and DE) partners had greater reductions in diabetes distress, greater increases in marital satisfaction (4 and 8 months), and some improvements in diastolic BP. There were no consistent differences among arms in other outcomes. There was no evidence of a dietary or activity behaviour ripple effect on untreated partners, i.e. comparing partners in the IC and DE arms. CONCLUSIONS A collaborative couples intervention resulted in significant improvements in partner diabetes distress and relationship satisfaction. There were no consistent effects on behavioural or medical partner outcomes, and no evidence of diet or activity behaviour ripple effects, suggesting that partners should be targeted directly to achieve these changes. (Clinical Trial Registry No: NCT01017523).",2019,"CC (vs. IC and DE) partners had greater reductions in diabetes distress, greater increases in marital satisfaction (4 and 8 months), and some improvements in diastolic BP.","['Couples included one partner with Type 2 diabetes and HbA 1c ≥\xa058\xa0mmol/mol (7.5', 'partners of persons with Type 2 diabetes', ""Partners' (N\xa0=\xa0268) mean age was 55.8\xa0years, 64.6% were female and 29.9% were from minority ethnic groups"", 'persons with Type 2 diabetes with those of untreated partners of participants in an']","['couples calls (CC), individual calls (IC) and diabetes education calls (DE', 'individual intervention or education', 'couples intervention', 'telephone couples behavioural intervention']","['diabetes distress', 'glycaemic control', 'psychosocial (diabetes distress, relationship satisfaction, depressive symptoms), medical (BMI, blood pressure) and behavioural (fat intake, activity', 'partner diabetes distress and relationship satisfaction', 'behavioural or medical partner outcomes', 'diastolic BP', 'marital satisfaction', 'dietary or activity behaviour ripple effect']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",1.0,0.0389012,"CC (vs. IC and DE) partners had greater reductions in diabetes distress, greater increases in marital satisfaction (4 and 8 months), and some improvements in diastolic BP.","[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Trief', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Department of Family Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sandberg', 'Affiliation': 'School of Family Life, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Hessler', 'Affiliation': 'Department of Family Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Cibula', 'Affiliation': 'Department of Public Health & Preventive Medicine, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'Department of Medicine, SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13871'] 524,32227179,Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial.,"Importance There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care. Objective To examine whether default options in ADs influence care choices and clinical outcomes. Design, Setting, and Participants This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019. Interventions Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD). Main Outcomes and Measures This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care. Results Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes. Conclusions and Relevance In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT02017548.",2020,"There were no differences among groups in other secondary outcomes. ","['Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months', 'November 2018 to April 2019', '515 patients who met criteria for having serious illness and agreed to participate', '515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer', 'Seriously Ill Patients', '492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the']","['comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD']","['comfort care', 'life-extending AD chose comfort care', ""choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care"", 'Hospital-Free Days and Care Choices', 'legally valid ADs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0150521', 'cui_str': 'Comfort Care'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0421611', 'cui_str': 'Place of death (observable entity)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",515.0,0.193088,"There were no differences among groups in other secondary outcomes. ","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cooney', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bayes', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Marzana', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tomko', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1742'] 525,31941795,Randomized controlled trial of N -acetylcysteine therapy for RYR1 -related myopathies.,"OBJECTIVE To investigate the efficacy of N -acetylcysteine (NAC) for decreasing elevated oxidative stress and increasing physical endurance in individuals with ryanodine receptor 1-related myopathies ( RYR1 -RM). METHODS In this 6-month natural history assessment (n = 37) followed by a randomized, double-blinded, placebo-controlled trial, 33 eligible participants were block-randomized (1:1) to receive NAC (n = 16) or placebo (n = 17), orally for 6 months (adult dose 2,700 mg/d; pediatric dose 30 mg/kg/d). The primary endpoint was urine 15-F2t isoprostane concentration and the clinically meaningful co-primary endpoint was 6-minute walk test (6MWT) distance. RESULTS When compared to the general population, participants had elevated baseline 15-F2t isoprostane concentrations and most had a decreased 6MWT distance (mean ± SD 3.2 ± 1.5 vs 1.1 ± 1.7 ng/mg creatinine and 468 ± 134 vs 600 ± 58 m, respectively, both p < 0.001). 15-F2t isoprostane concentration and 6MWT distance did not change over the 6-month natural history assessment ( p = 0.98 and p = 0.61, respectively). NAC treatment did not improve 15-F2t isoprostane concentration (least squares means difference 0.1 [95% confidence interval [CI] -1.4 to 1.6] ng/mg creatinine, p = 0.88) or 6MWT distance (least squares means difference 24 [95% CI -5.5 to 53.4] m, p = 0.11). NAC was safe and well-tolerated at the doses administered in this study. CONCLUSION In ambulatory RYR1 -RM-affected individuals, we observed stable disease course, and corroborated preclinical reports of elevated oxidative stress and decreased physical endurance. NAC treatment did not decrease elevated oxidative stress, as measured by 15-F2t isoprostane. CLASSIFICATION OF EVIDENCE This study provides Class I evidence that, for people with RYR1 -RM, treatment with oral NAC does not decrease oxidative stress as measured by 15-F2t isoprostane. CLINICALTRIALSGOV IDENTIFIER NCT02362425.",2020,"15-F2t isoprostane concentration and 6MWT distance did not change over the 6-month natural history assessment ( p = 0.98 and p = 0.61, respectively).","['RYR1 -related myopathies', 'individuals with ryanodine receptor 1-related myopathies ( RYR1 -RM', '33 eligible participants were block-randomized (1:1) to receive']","['N -acetylcysteine therapy', 'placebo', 'NAC', 'N -acetylcysteine (NAC', 'oral NAC']","['15-F2t isoprostane concentration', '6MWT distance', 'safe and well-tolerated', '15-F2t isoprostane concentration and 6MWT distance', 'oxidative stress', 'elevated oxidative stress', 'urine 15-F2t isoprostane concentration and the clinically meaningful co-primary endpoint was 6-minute walk test (6MWT) distance']","[{'cui': 'C0524965', 'cui_str': 'RyR1'}, {'cui': 'C0026848', 'cui_str': 'Muscle Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0042037'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444858', 'cui_str': 'AM 6 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",33.0,0.628661,"15-F2t isoprostane concentration and 6MWT distance did not change over the 6-month natural history assessment ( p = 0.98 and p = 0.61, respectively).","[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Todd', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Tokunbor A', 'Initials': 'TA', 'LastName': 'Lawal', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Witherspoon', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Irene C', 'Initials': 'IC', 'LastName': 'Chrismer', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Muslima S', 'Initials': 'MS', 'LastName': 'Razaqyar', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Monal', 'Initials': 'M', 'LastName': 'Punjabi', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Elliott', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Fatoumata', 'Initials': 'F', 'LastName': 'Tounkara', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kuo', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Monique O', 'Initials': 'MO', 'LastName': 'Shelton', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Cosgrove', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Linton', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Michael', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Minal S', 'Initials': 'MS', 'LastName': 'Jain', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Waite', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Drinkard', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Wakim', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dowling', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Carsten G', 'Initials': 'CG', 'LastName': 'Bönnemann', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Emile-Backer', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Katherine G', 'Initials': 'KG', 'LastName': 'Meilleur', 'Affiliation': 'From the Neuromuscular Symptoms Unit, National Institute of Nursing Research (J.J.T., T.A.L., J.W.W., I.C.C., M.S.R., M.P., J.S.E., F.T., A.K., M.O.S., C.A., M.M.C., M.L., M.E.-B., K.G.M.), Mark O. Hatfield Clinical Research Center, Rehabilitation Medicine Department (M.S.J., M.W., B.D.), and Neurogenetics Branch, National Institute of Neurological Disorders and Stroke (C.G.B.), NIH, Bethesda, MD; Hyperion Biotechnology Inc. (D.M.), San Antonio, TX; Biostatistics and Clinical Epidemiology Service (P.G.W.), NIH Clinical Center, Bethesda, MD; Division of Neurology and Program for Genetics and Genome Biology (J.J.D.) and Departments of Paediatrics and Molecular Genetics (J.J.D.), Hospital for Sick Children, Toronto, Canada. meilleurk@mail.nih.gov.'}]",Neurology,['10.1212/WNL.0000000000008872'] 526,31072282,Session-specific effects of the Metacognitive Training for Obsessive-Compulsive Disorder (MCT-OCD).,"Objective: Most studies focus on overall treatment effects by assessing symptom severity before and after treatment, but few investigate session-specific effects of an intervention. The aim of the present study was to elucidate session-specific effects of a group therapy for obsessive-compulsive disorder (OCD) that targets cognitive biases known as the Metacognitive Training for OCD (MCT-OCD). Method: In an uncontrolled pilot trial, 44 inpatients with OCD participated in the MCT-OCD once a week over four weeks. Before and after each session, patients answered questionnaires on thought monitoring, control of thoughts, obsessions, compulsions, and mood. Results: Primary analyses using linear mixed-effect models showed that the module on control of thoughts (within-session effect) significantly reduced patients' control of thoughts. Exploratory analyses displayed an improvement in thought monitoring, control of thoughts, obsessions, and compulsions over the treatment period. Control of thoughts decreaed after the module on biased attention/biased cognitive networks and compulsions reduced one week after the module on overestimation of threat/responsibility (between-session effect). More compulsions were reported one week after the module on thought-action fusion/control of thoughts. Conclusions: Certain MCT-OCD modules seemed to improve specific cognitive biases that might in turn act as mechanisms of change. The results are being used to revise the MCT-OCD.",2020,Control of thoughts decreaed after the module on biased attention/biased cognitive networks and compulsions reduced one week after the module on overestimation of threat/responsibility (between-session effect).,"['Obsessive-Compulsive Disorder (MCT-OCD', '44 inpatients with OCD participated in the', 'obsessive-compulsive disorder (OCD']","['MCT-OCD', 'Metacognitive Training']","['specific cognitive biases', 'thought monitoring, control of thoughts, obsessions, and compulsions', ""patients' control of thoughts""]","[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0233697', 'cui_str': 'Obsessions'}, {'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",44.0,0.020366,Control of thoughts decreaed after the module on biased attention/biased cognitive networks and compulsions reduced one week after the module on overestimation of threat/responsibility (between-session effect).,"[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Miegel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Cüneyt', 'Initials': 'C', 'LastName': 'Demiralay', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sure', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1613582'] 527,32103364,A segmentation-independent volume rendering visualisation method might reduce redundant explorations and post-surgical complications of microvascular decompression.,"OBJECTIVES This study aimed to investigate the feasibility of segmentation-independent volume rendering (SI-VR) in visualising the root entry zone (REZ), and to explore the influence on the management of vascular compression syndromes (VCSs). METHODS Two hundred and twenty patients with VCSs were recruited in this prospective study from July 2015 to May 2019. SI-VR was reconstructed based on inverted 3D fast spin echo T2WI. They were assigned to the experimental group and control group randomly. Patients in the experimental group would accept extra evaluation based on SI-VR before microvascular decompression. Image quality and diagnostic accuracy between SI-VR and 3D fast spin echo T2WI in the experimental group were compared by Mann-Whitney U test and chi-square test, separately. Interobserver agreement was performed with intraclass correlation coefficient. Postsurgical outcomes and complications between two groups were compared by chi-square test. RESULTS SI-VR had a better interobserver agreement (0.82 vs 0.68) and diagnostic accuracy (95.5% vs 83.6%, p = 0.004) than that of 3D fast spin echo T2WI. Especially, significantly improved diagnostic accuracy was reached in detecting the multi-vascular branches compression (100% vs 15.4%, p < 0.001). There were fewer complications (7.1% vs 26.8%, p = 0.004) and less operation time (20.7 min vs 14.5 min, p = 0.007) but no significant difference of pain relief (p = 0.19) in the experimental group than in the control group. CONCLUSIONS The SI-VR method is feasible for the precise demonstration of the anatomy structure along the REZ, with high reliability and reproducibility. Unbiased pre-surgical visualisation could reduce redundant explorations and post-surgical complications in patients who undergo microvascular decompression. KEY POINTS • Visualisation of the root entry zone by the segmentation-independent volume rendering is in accordance with the landscape by the neuro-endoscopy. • Segmentation-independent volume rendering has an advantage over 3D fast spin echo T2WI in the visualisation of multi-vascular branches compression. • Presurgical 3D visualisation of the neurovascular compression at the root entry zone leads to less postsurgical complications from the decrease of redundant exploration.",2020,"There were fewer complications (7.1% vs 26.8%, p = 0.004) and less operation time (20.7 min vs 14.5 min, p = 0.007) but no significant difference of pain relief (p = 0.19) in the experimental group than in the control group. ","['patients who undergo microvascular decompression', 'Two hundred and twenty patients with VCSs were recruited in this prospective study from July 2015 to May 2019']","['segmentation-independent volume rendering (SI-VR', 'SI-VR and 3D fast spin echo T2WI']","['complications', 'pain relief', 'diagnostic accuracy', 'operation time', 'SI-VR', 'Postsurgical outcomes and complications', 'multi-vascular branches compression', 'Image quality and diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",220.0,0.0194749,"There were fewer complications (7.1% vs 26.8%, p = 0.004) and less operation time (20.7 min vs 14.5 min, p = 0.007) but no significant difference of pain relief (p = 0.19) in the experimental group than in the control group. ","[{'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Qilu Hospital of Shandong University, Jinan, 250012, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Shandong Medical Imaging Research Institute, Shandong University, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ming', 'Affiliation': ""Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000, People's Republic of China.""}, {'ForeName': 'Mingxu', 'Initials': 'M', 'LastName': 'Ge', 'Affiliation': ""Department of Neurosurgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': ""School of Medicine, Shandong University, Jinan, 250012, People's Republic of China.""}, {'ForeName': 'Chuanting', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Shandong Medical Imaging Research Institute, Shandong University, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000, People's Republic of China.""}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Qingdao University Medical College, Qingdao, 266003, People's Republic of China.""}, {'ForeName': 'Shangchen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Neurosurgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, People's Republic of China. Shangchenxu@sina.com.""}, {'ForeName': 'Yingchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, People's Republic of China. 13805311573@126.com.""}]",European radiology,['10.1007/s00330-020-06715-x'] 528,32100628,Differences in the magnitude and reliability of velocity variables collected during 3 variants of the bench press exercise.,"This study aimed to compare the reliability and magnitude of velocity variables between 3 variants of the bench press (BP) exercise in participants with and without BP training experience. Thirty males, 15 with and 15 without BP experience, randomly performed 3 variants of the BP on separate sessions: (I) concentric-only, (II) fast-eccentric and (III) controlled-eccentric. The mean velocity (MV) and maximum velocity (V max ) of the concentric phase were collected against 3 loads (≈30%1RM, 50%1RM, and 75%1RM) with a linear velocity transducer. Reliability was high regardless of the variable, BP variant, and load (coefficient of variation [CV] ≤ 4.47%, intraclass correlation coefficient [ICC] ≥ 0.87). The comparison of the CVs suggested a higher reliability for the fast-eccentric BP (8 out of 12 comparisons), followed by the concentric-only BP (5 out of 12 comparisons), and finally the controlled-eccentric BP (never provided a higher reliability). No differences in reliability were observed between experienced (CV ≤ 4.71%; ICC ≥ 0.79) and non-experienced (CV ≤ 6.29%; ICC ≥ 0.76) participants. The fast-eccentric BP provided the highest MV ( p < 0.05) and no differences were observed for V max . These results support the assessment of movement velocity during the fast-eccentric BP even in participants without experience.",2020,The fast-eccentric BP provided the highest MV ( p < 0.05) and no differences were observed for V max .,"['Thirty males, 15 with and 15 without BP experience', 'participants with and without BP training experience']","['bench press (BP) exercise', 'concentric-only, (II) fast-eccentric and (III) controlled-eccentric']","['reliability', 'mean velocity (MV) and maximum velocity (V max ) of the concentric phase', 'BP variant, and load (coefficient of variation [CV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]",30.0,0.027596,The fast-eccentric BP provided the highest MV ( p < 0.05) and no differences were observed for V max .,"[{'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': 'University of Belgrade, Faculty of Sport and Physical Education, The Research Centre, Belgrade, Serbia.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'González-Hernández', 'Affiliation': 'Faculty of Health Science, Universidad Europea De Canarias, La Orotava, Spain.'}, {'ForeName': 'Yaodong', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Faculty of Sports Science, Ningbo University, Ningbo, China.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'Garcia-Ramos', 'Affiliation': 'Faculty of Sport Sciences, Department of Physical Education and Sport, University of Granada, Granada, Spain.'}]",Journal of sports sciences,['10.1080/02640414.2020.1734299'] 529,32106780,Near-infrared spectroscopy-derived total haemoglobin as an indicator of changes in muscle blood flow during exercise-induced hyperaemia.,"Blood flow changes in response to exercise have been attributed, among other factors, to the effect of vasodilators factors on the microvasculature, suggesting a close relationship between small blood vessels and conducting arteries. The main purpose of this study was to determine the relationship between the changes in near infrared spectroscopy (NIRS)-derived total haemoglobin ([tHb]) and muscle oxygen saturation (SmO 2 ) signals and femoral artery blood flow in response to resistance exercise at fast- and slow-velocity muscle contraction. The study randomised crossover design included twelve participants. NIRS and blood flow measurements were continuously monitored before, during, and 5 min after the exercise protocol. There was a significant correlation between [tHb] reperfusion slope ([tHb] slope ) and peak blood flow (BF peak ) after slow- and fast-velocity muscle contraction (r = 0.83, p = 0.0008 and r = 0.72, p = 0.0080, respectively). No significant correlation existed between the SmO 2 reperfusion slope (SmO 2_slope ) and BF peak after both slow- and fast-velocity muscle contraction exercise (r = -0.46, p = 0.1253 and r = 0.33, p = 0.2841, respectively). This study demonstrated a strong relationship between the NIRS-derived [tHb] and Doppler ultrasound BF during the recovery period of dynamic resistance exercise at both slow- and fast-velocity contraction.",2020,"There was a significant correlation between [tHb] reperfusion slope ([tHb] slope ) and peak blood flow (BF peak ) after slow- and fast-velocity muscle contraction (r = 0.83, p = 0.0008 and r = ",['twelve participants'],['NIRS-derived [tHb] and Doppler ultrasound BF'],"['SmO 2 reperfusion slope (SmO 2_slope ) and BF peak after both slow- and fast-velocity muscle contraction exercise', 'near infrared spectroscopy (NIRS)-derived total haemoglobin ([tHb]) and muscle oxygen saturation (SmO 2 ) signals and femoral artery blood flow', 'NIRS and blood flow measurements', 'tHb] reperfusion slope ([tHb] slope ) and peak blood flow (BF peak ) after slow- and fast-velocity muscle contraction']",[],"[{'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0026820', 'cui_str': 'Muscular Contraction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",12.0,0.0441965,"There was a significant correlation between [tHb] reperfusion slope ([tHb] slope ) and peak blood flow (BF peak ) after slow- and fast-velocity muscle contraction (r = 0.83, p = 0.0008 and r = ","[{'ForeName': 'Thiago Silveira', 'Initials': 'TS', 'LastName': 'Alvares', 'Affiliation': 'Postgraduate Program in Bioactive Products and Biosciences, Federal University of Rio de Janeiro, Rio De Janeiro, Brazil.'}, {'ForeName': 'Gustavo Vieira de', 'Initials': 'GV', 'LastName': 'Oliveira', 'Affiliation': 'Postgraduate Program in Bioactive Products and Biosciences, Federal University of Rio de Janeiro, Rio De Janeiro, Brazil.'}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Soares', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Murias', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}]",Journal of sports sciences,['10.1080/02640414.2020.1733774'] 530,31325802,Kynurenine metabolism and inflammation-induced depressed mood: A human experimental study.,"Inflammation has an important physiological influence on mood and behavior. Kynurenine metabolism is hypothesized to be a pathway linking inflammation and depressed mood, in part through the impact of kynurenine metabolites on glutamate neurotransmission in the central nervous system. This study evaluated whether the circulating concentrations of kynurenine and related compounds change acutely in response to an inflammatory challenge (endotoxin administration) in a human model of inflammation-induced depressed mood, and whether such metabolite changes relate to mood change. Adults (n = 115) were randomized to receive endotoxin or placebo. Mood (Profile of Mood States), plasma cytokine (interleukin-6, tumor necrosis factor-α) and metabolite (kynurenine, tryptophan, kynurenic acid, quinolinic acid) concentrations were repeatedly measured before the intervention, and at 2 and 6 h post-intervention. Linear mixed models were used to evaluate relationships between mood, kynurenine and related compounds, and cytokines. Kynurenine, kynurenic acid, and tryptophan (but not quinolinic acid) concentrations changed acutely (p's all <0.001) in response to endotoxin as compared to placebo. Neither kynurenine, kynurenic acid nor tryptophan concentrations were correlated at baseline with cytokine concentrations, but all three were significantly correlated with cytokine concentrations over time in response to endotoxin. Quinolinic acid concentrations were not correlated with cytokine concentrations either before or following endotoxin treatment. In those who received endotoxin, kynurenine (p = 0.049) and quinolinic acid (p = 0.03) positively correlated with depressed mood, although these findings would not survive correction for multiple testing. Changes in tryptophan and kynurenine pathway metabolites did not mediate the relationship between cytokines and depressed mood. Further work is necessary to clarify the pathways leading from inflammation to depressed mood in humans.",2019,"In those who received endotoxin, kynurenine (p = 0.049) and quinolinic acid (p = 0.03) positively correlated with depressed mood, although these findings would not survive correction for multiple testing.",['Adults (n\u202f=\u202f115'],"['endotoxin or placebo', 'placebo', 'endotoxin, kynurenine']","['Mood (Profile of Mood States), plasma cytokine (interleukin-6, tumor necrosis factor-α) and metabolite (kynurenine, tryptophan, kynurenic acid, quinolinic acid) concentrations', 'quinolinic acid', 'kynurenine, kynurenic acid nor tryptophan concentrations', 'Kynurenine, kynurenic acid, and tryptophan', 'Quinolinic acid concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0022816', 'cui_str': '2-Quinolinecarboxylic acid, 4-hydroxy-'}, {'cui': 'C0072879', 'cui_str': '2,3-Pyridinedicarboxylic acid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0299068,"In those who received endotoxin, kynurenine (p = 0.049) and quinolinic acid (p = 0.03) positively correlated with depressed mood, although these findings would not survive correction for multiple testing.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kruse', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States.'}, {'ForeName': 'Joshua Hyong-Jin', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States. Electronic address: hjcho@mednet.ucla.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Olmstead', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Hwang', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States; Pasarow Mass Spectrometry Laboratory, University of California Los Angeles, United States.'}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Faull', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States; Pasarow Mass Spectrometry Laboratory, University of California Los Angeles, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Department of Psychology, University of California Los Angeles, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, University of California Los Angeles, United States; Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104371'] 531,30629473,Effect of frequent interruptions of sedentary time on nutrient metabolism in sedentary overweight male and female adults.,"This study compared 24-h nutrient oxidation responses between a sedentary condition (SED) and a condition in which short 5-min bouts of moderate-intensity physical activity were performed hourly for nine consecutive hours over 4 days (MICRO). To determine whether any shifts in fuel use were due solely to increases in energy expenditure, we also studied a condition consisting of a single isoenergetic 45-min bout of moderate-intensity exercise (ONE). Twenty sedentary overweight or obese adults (10 men/10 women; 32.4 ± 6.3 yr; BMI, 30.6 ± 2.9 kg/m 2 ) completed all three conditions (MICRO, SED, and ONE) in a randomized order. Each condition consisted of a 3-day free-living run-in followed by a 24-h stay in a whole-room calorimeter to measure total energy expenditure (TEE) and substrate utilization. Dietary fat oxidation was also assessed during the chamber stay by administering a [1- 13 C] oleic acid tracer at breakfast. Energy intake was matched across conditions. Both MICRO and ONE increased TEE relative to SED, resulting in a negative energy balance. HOMA-IR improved in both activity conditions. MICRO increased 24-h carbohydrate oxidation compared with both ONE and SED ( P < 0.01 for both). ONE was associated with higher 24-h total fat oxidation compared with SED, and higher 24-h dietary fat oxidation compared with both SED and MICRO. Differences in substrate oxidation remained significant after adjusting for energy balance. In overweight and obese men and women, breaking up sitting time increased reliance upon carbohydrate as fuel over 24 h, while a single energy-matched continuous bout of exercise preferentially relies upon fat over 24 h. NEW & NOTEWORTHY Insulin sensitivity, as assessed by HOMA-IR, was improved after 4 days of physical activity, independent of frequency and duration of activity bouts. Temporal patterns of activity across the day differentially affect substrate oxidation. Frequent interruptions of sedentary time with short bouts of walking primarily increase 24-h carbohydrate oxidation, whereas an energy-matched single continuous bout of moderate intensity walking primarily increased 24-h fat oxidation.",2019,"ONE was associated with higher 24-h total fat oxidation compared with SED, and higher 24-h dietary fat oxidation compared with both SED and MICRO.","['sedentary overweight male and female adults', 'Twenty sedentary overweight or obese adults (10 men/10 women; 32.4\u2009±\u20096.3 yr; BMI, 30.6\u2009±\u20092.9 kg/m 2 ) completed all three conditions (MICRO, SED, and ONE) in a randomized order']",['sedentary time'],"['substrate oxidation', 'Energy intake', '24-h carbohydrate oxidation', 'MICRO increased 24-h carbohydrate oxidation', 'Dietary fat oxidation', 'nutrient metabolism', '24-h total fat oxidation', '24-h dietary fat oxidation', '24-h fat oxidation', 'HOMA-IR']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",20.0,0.0201236,"ONE was associated with higher 24-h total fat oxidation compared with SED, and higher 24-h dietary fat oxidation compared with both SED and MICRO.","[{'ForeName': 'Nathan P', 'Initials': 'NP', 'LastName': 'De Jong', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes and Anschutz Health and Wellness Center, University of Colorado, School of Medicine , Aurora, Colorado.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Rynders', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado, School of Medicine , Aurora, Colorado.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Goldstrohm', 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, Perinatal Research Center , Aurora, Colorado.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biostatistics and Informatics, Anschutz Medical Campus, University of Colorado , Aurora, Colorado.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Lange', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes and Anschutz Health and Wellness Center, University of Colorado, School of Medicine , Aurora, Colorado.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Mendez', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes and Anschutz Health and Wellness Center, University of Colorado, School of Medicine , Aurora, Colorado.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado, School of Medicine , Aurora, Colorado.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes and Anschutz Health and Wellness Center, University of Colorado, School of Medicine , Aurora, Colorado.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bergouignan', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes and Anschutz Health and Wellness Center, University of Colorado, School of Medicine , Aurora, Colorado.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00632.2018'] 532,32224045,The impact of a disease flare during tapering of DMARDs on the lives of rheumatoid arthritis patients.,"OBJECTIVES To determine the impact of a disease flare on patient reported outcome measures (PROMs) in rheumatoid arthritis (RA) patients, who are tapering treatment. METHODS Data were used from the TARA trial; a multicenter, randomized controlled trial in which RA patients, with a well-controlled disease (DAS≤2.4 and SJC≤1) for at least 6 months, gradually tapered their DMARDs. PROMs of patients with a flare (DAS>2.4 and/or SJC>1) were compared every three months before and after a flare with their own norm values. Linear Mixed Models were used to investigate whether a disease flare influenced functional ability (HAQ-DI), fatigue (BRAF-MDQ), quality of life (EQ-5D and SF36), anxiety and depression (HADS), morning stiffness, general health (GH) and worker productivity, and if so, the duration was determined. For unemployment and sick leave we used descriptive statistics. RESULTS A flare negatively influenced GH, morning stiffness, HAQ-DI, EQ-5D, BRAF-MDQ, and the SF36 physical component scale and this effect lasted >3 months. Except for the HAQ-DI, effect sizes exceeded the minimum clinically important differences (MCIDs). For the physical outcomes effects lasted >6 months. Worker productivity was not significantly affected by a flare. CONCLUSION A disease flare influenced patients' lives, the largest effect was seen in the physical outcomes, and lasted 6 months. Although on a group level effect sizes for the separate PROMs were not always significant or larger than specific MCIDs, a disease flare can still be of great importance for individual patients.",2020,"A flare negatively influenced GH, morning stiffness, HAQ-DI, EQ-5D, BRAF-MDQ, and the SF36 physical component scale and this effect lasted >3 months.","['rheumatoid arthritis (RA) patients, who are tapering treatment', 'RA patients, with a well-controlled disease (DAS≤2.4 and SJC≤1) for at least 6 months, gradually tapered their DMARDs', 'rheumatoid arthritis patients']",[],"['functional ability (HAQ-DI), fatigue (BRAF-MDQ), quality of life (EQ-5D and SF36), anxiety and depression (HADS), morning stiffness, general health (GH) and worker productivity, and if so, the duration', 'GH, morning stiffness, HAQ-DI, EQ-5D, BRAF-MDQ, and the SF36 physical component scale', 'Worker productivity']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0222045'}]",,0.0293131,"A flare negatively influenced GH, morning stiffness, HAQ-DI, EQ-5D, BRAF-MDQ, and the SF36 physical component scale and this effect lasted >3 months.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Department of Rheumatology, Erasmus MC, Rotterdam, the Netherlands. Electronic address: elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'A E A M', 'Initials': 'AEAM', 'LastName': 'Weel', 'Affiliation': 'Department of Rheumatology, Erasmus MC, Rotterdam, the Netherlands; Department of Rheumatology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Kuijper', 'Affiliation': 'Department of Rheumatology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'J M W', 'Initials': 'JMW', 'LastName': 'Hazes', 'Affiliation': 'Department of Rheumatology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'A H M', 'Initials': 'AHM', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Department of Rheumatology, Erasmus MC, Rotterdam, the Netherlands; Department of Rheumatology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'P H P', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Department of Rheumatology, Erasmus MC, Rotterdam, the Netherlands.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.02.011'] 533,31446845,Cardiopulmonary bypass and dual antiplatelet therapy: a strategy to minimise transfusions and blood loss.,"BACKGROUND Patients with preoperative dual antiplatelet therapy prior to coronary artery bypass surgery are at risk of bleeding and blood component transfusion. We hypothesise that an optimised cardiopulmonary bypass strategy reduces postoperative blood loss and transfusions. METHODS In total, 60 patients admitted for coronary artery bypass grafting with ticagrelor and aspirin medication withdrawn <96 hours before surgery were prospectively randomised into two equal sized groups. Cardiopulmonary bypass combined a closed Cortiva ® heparin-coated circuit with low systemic heparinisation (activated clotting time < 250 seconds) and intraoperative cell salvage in the study group, whereas the control group used a Balance ® coated open circuit, full systemic heparinisation (activated clotting time > 480 seconds) and conventional cardiotomy suction. This perfusion strategy was evaluated by the chest drain volume after 24 hours, perioperative haemoglobin and platelet loss accompanied by global coagulation assessments. RESULTS Patients in the study group demonstrated significantly better outcomes signified by lower blood loss 554 ± 224 versus 1,100 ± 989 mL (p < 0.001), reduced packed red cell transfusion 7% versus 53% (p < 0.001), reduced haemoglobin -28 ± 15 versus -40 ± 14 g/L (p = 0.004) and platelet loss -35 ± 36 versus -82 ± 67 × 10 9 /L (p = 0.001). Indices of rotational thromboelastometry indicated shorter clotting times within the internal and external pathways. Adenosine diphosphate activated platelet function was within normal range based on Multiplate ® aggregometry, while ROTEM ® platelet analyses indicated inhibited function both preoperatively and post-bypass. Platelet inhibition by aspirin was verified throughout the perioperative period. Platelet function showed no intergroup differences. CONCLUSION A stringent perfusion strategy reduced blood loss and transfusions in dual antiplatelet therapy patients requiring urgent surgery.",2020,"Platelet function showed no intergroup differences. ","['60 patients admitted for coronary artery bypass grafting with ticagrelor and aspirin medication withdrawn <96\u2009hours before surgery', 'Patients with preoperative dual antiplatelet therapy prior to coronary artery bypass surgery', 'dual antiplatelet therapy patients requiring urgent surgery']","['aspirin', 'Balance ® coated open circuit, full systemic heparinisation (activated clotting time\u2009>\u2009480\u2009seconds) and conventional cardiotomy suction', 'Cardiopulmonary bypass combined a closed Cortiva ® heparin-coated circuit with low systemic heparinisation (activated clotting time\u2009<\u2009250\u2009seconds) and intraoperative cell salvage', 'Cardiopulmonary bypass and dual antiplatelet therapy']","['reduced packed red cell transfusion', 'Platelet function', 'postoperative blood loss and transfusions', 'blood loss and transfusions', 'Platelet inhibition', 'shorter clotting times']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0189758', 'cui_str': 'Incision of heart'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.0205586,"Platelet function showed no intergroup differences. ","[{'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Karlsson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Heart Centre, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Hannuksela', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Heart Centre, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Micael', 'Initials': 'M', 'LastName': 'Appelblad', 'Affiliation': 'Department of Public Health and Clinical Medicine, Heart Centre, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Hällgren', 'Affiliation': 'Department of Public Health and Clinical Medicine, Heart Centre, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Johagen', 'Affiliation': 'Department of Public Health and Clinical Medicine, Heart Centre, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wahba', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Svenmarker', 'Affiliation': 'Department of Public Health and Clinical Medicine, Heart Centre, Umeå University, Umeå, Sweden.'}]",Perfusion,['10.1177/0267659119867005'] 534,30664239,Deprescribing in the Pharmacologic Management of Delirium: A Randomized Trial in the Intensive Care Unit.,"OBJECTIVE Benzodiazepines and anticholinergics are risk factors for delirium in the intensive care unit (ICU). We tested the impact of a deprescribing intervention on short-term delirium outcomes. DESIGN Multisite randomized clinical trial. SETTING ICUs of three large hospitals. PARTICIPANTS Two hundred adults aged 18 years or older and admitted to an ICU with delirium, according to the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU). Participants had a contraindication to haloperidol (seizure disorder or prolonged QT interval) or preference against haloperidol as a treatment for delirium, and were excluded for serious mental illness, stroke, pregnancy, or alcohol withdrawal. Participants were randomized to a deprescribing intervention or usual care. The intervention included electronic alerts combined with pharmacist support to deprescribe anticholinergics and benzodiazepines. MEASUREMENTS Primary outcomes were delirium duration measured by the CAM-ICU and severity measured by the Delirium Rating Scale Revised-98 (DRS-R-98) and the CAM-ICU-7; secondary outcomes included adverse events and mortality. RESULTS Participants had a mean age of 61.8 (SD = 14.3) years, 59% were female, and 52% were African American, with no significant differences in baseline characteristics between groups. No differences between groups were identified in the number exposed to anticholinergics (P = .219) or benzodiazepines (P = .566), the median total anticholinergic score (P = .282), or the median total benzodiazepine dose in lorazepam equivalents (P = .501). Neither median delirium/coma-free days (P = .361) nor median change in delirium severity scores (P = .582 for DRS-R-98; P = .333 for CAM-ICU-7) were different between groups. No differences in adverse events or mortality were identified. CONCLUSIONS When added to state-of-the-art clinical services, this deprescribing intervention had no impact on medication use in ICU participants. Given the age of the population, results of clinical outcomes may not be easily extrapolated to older adults. Nonetheless, improved approaches for deprescribing or preventing anticholinergics and benzodiazepines should be developed to determine the impact on delirium outcomes. J Am Geriatr Soc 67:695-702, 2019.",2019,"No differences between groups were identified in the number exposed to anticholinergics (P = .219) or benzodiazepines (P = .566), the median total anticholinergic score (P = .282), or the median total benzodiazepine dose in lorazepam equivalents (P = .501).","['Delirium', 'Two hundred adults aged 18 years or older and admitted to an ICU with delirium, according to the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU', 'Participants had a contraindication to haloperidol (seizure disorder or prolonged QT interval) or preference against haloperidol as a treatment for delirium, and were excluded for serious mental illness, stroke, pregnancy, or alcohol withdrawal', 'ICUs of three large hospitals']","['Benzodiazepines and anticholinergics', 'deprescribing intervention or usual care', 'deprescribing intervention', 'electronic alerts combined with pharmacist support to deprescribe anticholinergics and benzodiazepines', 'benzodiazepines']","['delirium duration measured by the CAM-ICU and severity measured by the Delirium Rating Scale Revised-98 (DRS-R-98) and the CAM-ICU-7; secondary outcomes included adverse events and mortality', 'delirium severity scores', 'median total anticholinergic score', 'adverse events or mortality', 'median total benzodiazepine dose in lorazepam equivalents']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval (finding)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",200.0,0.137567,"No differences between groups were identified in the number exposed to anticholinergics (P = .219) or benzodiazepines (P = .566), the median total anticholinergic score (P = .282), or the median total benzodiazepine dose in lorazepam equivalents (P = .501).","[{'ForeName': 'Noll L', 'Initials': 'NL', 'LastName': 'Campbell', 'Affiliation': 'Purdue University College of Pharmacy, West Lafayette, Indiana.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Indiana University Center for Health Innovation and Implementation Science and Indiana Clinical and Translational Sciences Institute, Indianapolis, Indiana.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}, {'ForeName': 'Mark O', 'Initials': 'MO', 'LastName': 'Farber', 'Affiliation': 'Department of Medicine Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sikandar', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Malaz A', 'Initials': 'MA', 'LastName': 'Boustani', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15751'] 535,32224306,"Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial.","BACKGROUND Few options exist for treatment of patients with small-cell lung cancer (SCLC) after failure of first-line therapy. Lurbinectedin is a selective inhibitor of oncogenic transcription. In this phase 2 study, we evaluated the acti and safety of lurbinectedin in patients with SCLC after failure of platinum-based chemotherapy. METHODS In this single-arm, open-label, phase 2 basket trial, we recruited patients from 26 hospitals in six European countries and the USA. Adults (aged ≥18 years) with a pathologically proven diagnosis of SCLC, Eastern Cooperative Oncology Group performance status of 2 or lower, measurable disease as per Response Criteria in Solid Tumors (RECIST) version 1.1, absence of brain metastasis, adequate organ function, and pre-treated with only one previous chemotherapy-containing line of treatment (minimum 3 weeks before study initiation) were eligible. Treatment consisted of 3·2 mg/m 2 lurbinectedin administered as a 1-h intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. The primary outcome was the proportion of patients with an overall response (complete or partial response) as assessed by the investigators according to RECIST 1.1. All treated patients were analysed for activity and safety. This study is ongoing and is registered with ClinicalTrials.gov, NCT02454972. FINDINGS Between Oct 16, 2015, and Jan 15, 2019, 105 patients were enrolled and treated with lurbinectedin. Median follow-up was 17·1 months (IQR 6·5-25·3). Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2). The most common grade 3-4 adverse events (irrespective of causality) were haematological abnormalities-namely, anaemia (in nine [9%] patients), leucopenia (30 [29%]), neutropenia (48 [46%]), and thrombocytopenia (seven [7%]). Serious treatment-related adverse events occurred in 11 (10%) patients, of which neutropenia and febrile neutropenia were the most common (five [5%] patients for each). No treatment-related deaths were reported. INTERPRETATION Lurbinectedin was active as second-line therapy for SCLC in terms of overall response and had an acceptable and manageable safety profile. Lurbinectedin could represent a potential new treatment for patients with SCLC, who have few options especially in the event of a relapse, and is being investigated in combination with doxorubicin as second-line therapy in a randomised phase 3 trial. FUNDING Pharma Mar.",2020,Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2).,"['Between Oct 16, 2015, and Jan 15, 2019, 105 patients were enrolled and treated with', 'recruited patients from 26 hospitals in six European countries and the USA', 'patients with SCLC', 'Adults (aged ≥18 years) with a pathologically proven diagnosis of SCLC, Eastern Cooperative Oncology Group performance status of 2 or lower, measurable disease as per Response Criteria in Solid Tumors', 'patients with SCLC after failure of platinum-based chemotherapy', 'patients with small-cell lung cancer (SCLC) after failure of first-line therapy', 'patients with small-cell lung cancer']","['doxorubicin', 'Lurbinectedin', '3·2 mg/m 2 lurbinectedin', 'lurbinectedin']","['leucopenia', 'Overall response', 'proportion of patients with an overall response (complete or partial response', 'activity and safety', 'adverse events', 'neutropenia', 'haematological abnormalities-namely, anaemia', 'neutropenia and febrile neutropenia', 'thrombocytopenia']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C3898565'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",105.0,0.123332,Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2).,"[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Trigo', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain. Electronic address: jmtrigo@seom.org.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Subbiah', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Gustave Roussy Cancer Campus, Villejuif, France; Paris Sud University, Orsay, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'START Madrid-Fundación Jiménez Díaz, Hospital Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'María Angeles', 'Initials': 'MA', 'LastName': 'Sala', 'Affiliation': 'Organización Sanitaria Integrada Bilbao Basurto, Bilbao, Spain.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'University Hospital Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Madrid, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Fernández', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gómez', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Kahatt', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zeaiter', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'University Hospital Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Boni', 'Affiliation': 'START Madrid-Centro Integral Oncológico Clara Campal, Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Arrondeau', 'Affiliation': 'Hôpital Cochin, Paris, France.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Martínez', 'Affiliation': 'Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'University College London Cancer Institute, London, UK.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Olmedo', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Wannesson', 'Affiliation': 'Ospedale San Giovanni, Bellinzona, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valdivia', 'Affiliation': 'Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Rubio', 'Affiliation': 'Hospital Universitario Reina Sofía, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anton', 'Affiliation': 'Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sarantopoulos', 'Affiliation': 'Institute for Drug Development, Mays Cancer Center at University of Texas Health San Antonio, MD Anderson Cancer Center, San Antonio, TX, USA.'}, {'ForeName': 'Sant P', 'Initials': 'SP', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Center, Santa Monica, CA, USA.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Mosquera-Martinez', 'Affiliation': 'Complexo Hospitalario Universitario A Coruña, A Coruña, Spain.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': ""D'Arcangelo"", 'Affiliation': 'Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Istituto Clinico Humanitas, Rossano, Italy.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Villalobos', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Sands', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Madrid, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30068-1'] 536,30797387,An intervention to improve provider-patient interaction at methadone maintenance treatment in China.,"BACKGROUND This study evaluated an intervention aiming to improve methadone maintenance therapy (MMT) service providers' interaction with their patients in China. METHODS Sixty-eight MMT clinics were randomized to either an intervention or a control condition. Providers in the intervention group attended three group training sessions to enhance their communication skills. Trained providers were encouraged to practice the taught communication skills through provider-initiated individual sessions with their patients. A total of 418 service providers completed assessments from baseline to 24-month. Linear mixed-effects regression models were used to compare self-reported short-term and sustained improvement in provider-patient interaction between the intervention and the control conditions. RESULTS The intervention group service providers perceived significantly greater short-term and sustained improvement in provider-patient interaction compared to the control group service providers (estimated difference (±SE): 1.20 (0.24) and 1.35 (0.33), respectively; p-values < 0.0001). Providers' baseline job satisfaction was significantly associated with a greater perceived improvement in provider-patient interaction for both periods (reg. coef. (±SE): 0.02 (0.01) and 0.04 (0.01) for short-term and sustained periods, respectively; p-values < 0.01). CONCLUSION Study findings suggest that the intervention could be beneficial for improving perceived provider-patient interaction in MMT programs. Service providers' job satisfaction should be addressed in training programs for the improvement of provider-patient interaction.",2019,"The intervention group service providers perceived significantly greater short-term and sustained improvement in provider-patient interaction compared to the control group service providers (estimated difference (±SE): 1.20 (0.24) and 1.35 (0.33), respectively; p-values < 0.0001).","['China', 'Sixty-eight MMT clinics', '418 service providers', ""service providers' interaction with their patients in China""]",['methadone maintenance therapy (MMT'],"[""Providers' baseline job satisfaction"", 'short-term and sustained improvement in provider-patient interaction']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0046370', 'cui_str': 'MMT'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",418.0,0.0314006,"The intervention group service providers perceived significantly greater short-term and sustained improvement in provider-patient interaction compared to the control group service providers (estimated difference (±SE): 1.20 (0.24) and 1.35 (0.33), respectively; p-values < 0.0001).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA. Electronic address: lililili@ucla.edu.'}, {'ForeName': 'Li-Jung', 'Initials': 'LJ', 'LastName': 'Liang', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Feng', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Zunyou', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'National Center for AIDS/STD Control and Prevention, Chinese Centers for Disease Control and Prevention, Beijing, China.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.022'] 537,30797391,Randomized controlled trial of enhanced telephone monitoring with detoxification patients: 3- and 6-month outcomes.,"Telehealth interventions have the potential to deter repeated detoxification episodes and improve outcomes. Using a sample of 298 detoxification inpatients, this randomized controlled trial compared Enhanced Telephone Monitoring (ETM) to usual care (UC) on the primary outcome of reducing subsequent detoxification, and secondary outcomes of linking patients to addiction treatment and mutual-help, and patients' experience of improved substance use and mental health outcomes. At the 3-month follow-up (i.e., at the end of the ETM intervention), compared to UC patients, ETM patients were significantly less likely to have received additional inpatient detoxification, but no more likely to have participated in 12-step groups or received outpatient addiction treatment. Even so, ETM patients had better alcohol, drug, and mental health outcomes. In contrast, at the 6-month follow-up, patients in ETM and UC generally did not differ on primary or secondary outcomes. Findings suggest that ETM deters additional detoxification episodes while the intervention is ongoing, but not after the intervention ends. Because telephone monitoring is low-intensity and low-cost, its extension over time may help reduce repeated detoxifications.",2019,"In contrast, at the 6-month follow-up, patients in ETM and UC generally did not differ on primary or secondary outcomes.","['298 detoxification inpatients', 'patients']","['ETM', 'enhanced telephone monitoring with detoxification', 'Enhanced Telephone Monitoring (ETM) to usual care (UC']",['substance use and mental health outcomes'],"[{'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",298.0,0.0806467,"In contrast, at the 6-month follow-up, patients in ETM and UC generally did not differ on primary or secondary outcomes.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Timko', 'Affiliation': 'Center for Innovation to Implementation, Department of Veterans Affairs Health Care System, Palo Alto, CA 94304, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA. Electronic address: ctimko@stanford.edu.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Below', 'Affiliation': 'VA Boston Health Care System, 150 South Huntington Ave. (116b), Boston, MA 02130, USA; Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA. Electronic address: Maureen.Below@va.gov.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vittorio', 'Affiliation': 'VA Boston Health Care System, 150 South Huntington Ave. (116b), Boston, MA 02130, USA. Electronic address: Lisa.Vittorio@va.gov.'}, {'ForeName': 'Emmeline', 'Initials': 'E', 'LastName': 'Taylor', 'Affiliation': 'Center for Innovation to Implementation, Department of Veterans Affairs Health Care System, Palo Alto, CA 94304, USA. Electronic address: Emmeline.Taylor@va.gov.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'VA Boston Health Care System, 940 Belmont St., Brockton, MA 02301, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck St., Boston, MA 02115, USA. Electronic address: Grace.Chang2@va.gov.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lash', 'Affiliation': 'VA Medical Center, 1970 Roanoke Blvd, Salem, VA 24153, USA; Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA 22094, USA; Virgina Tech Carillon School of Medicine and Research Institute, 2 Riverside Circle, Roanoke, VA 24016, USA. Electronic address: Steven.Lash@va.gov.'}, {'ForeName': 'Fe Erlita D', 'Initials': 'FED', 'LastName': 'Festin', 'Affiliation': 'VA Boston Health Care System, 940 Belmont St., Brockton, MA 02301, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck St., Boston, MA 02115, USA. Electronic address: fe.festin@va.gov.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Brief', 'Affiliation': 'VA Boston Health Care System, 150 South Huntington Ave. (116b), Boston, MA 02130, USA; Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA. Electronic address: Deborah.Brief@va.gov.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.12.008'] 538,32037861,Phase I randomized single-blinded controlled study investigating the potential benefit of aerobic exercise in degenerative cerebellar disease.,"OBJECTIVES To investigate whether people with cerebellar degeneration can perform rigorous aerobic exercise and to assess the clinical impact of training. DESIGN Randomized single-blinded controlled, feasibility study comparing aerobic training to no training. SETTING Home intervention, assessments conducted at an academic medical center. SUBJECTS Twenty individuals with cerebellar degeneration caused by a range of genetic disorders. INTERVENTION Aerobic training consisted of four weeks of stationary bicycle training, five times per week for 30-minute sessions. Intensity ranged from 65% to 80% of the participant's maximal heart rate determined during cardiopulmonary exercise testing. MAIN MEASURES Primary outcome measure was change in the Scale for the Assessment and Rating of Ataxia scores. Recruitment rate, adherence, drop-out, and adverse events were also determined. The treatment was considered technically feasible if participants achieved target training frequency, duration, and intensity. RESULTS The 20 participants mean age was 50 years (standard deviation 15.65 years) and average Scale for the Assessment and Rating of Ataxia score was 9.6 (standard deviation 3.13). Ten participants were randomized to aerobic training and 10 to no training. Seven participants in the aerobic group attained target training duration, frequency, and intensity. There was a mean reduction in ataxia severity of 2.1 points (standard deviation 1.26) with four weeks of aerobic training, whereas ataxia severity increased by 0.3 (standard deviation 0.62) in the control group over the same period. Walking speed, balance measures, and fitness also improved in individuals who performed aerobic exercise. CONCLUSIONS Rigorous aerobic training is feasible in people with cerebellar degeneration. Improvements in ataxia, balance, and gait are promising.",2020,"There was a mean reduction in ataxia severity of 2.1 points (standard deviation 1.26) with four weeks of aerobic training, whereas ataxia severity increased by 0.3 (standard deviation 0.62) in the control group over the same period.","['Twenty individuals with cerebellar degeneration caused by a range of genetic disorders', 'degenerative cerebellar disease', 'people with cerebellar degeneration', 'Home intervention, assessments conducted at an academic medical center', '20 participants mean age was 50\u2009years (standard deviation 15.65\u2009years) and average Scale for the Assessment and Rating of Ataxia score was 9.6 (standard deviation 3.13']","['aerobic training to no training', 'aerobic training', 'aerobic exercise', 'Aerobic training consisted of four weeks of stationary bicycle training', 'aerobic training and 10 to no training']","['target training duration, frequency, and intensity', 'maximal heart rate', 'ataxia, balance, and gait', 'Walking speed, balance measures, and fitness', 'target training frequency, duration, and intensity', 'change in the Scale for the Assessment and Rating of Ataxia scores', 'ataxia severity', 'Recruitment rate, adherence, drop-out, and adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0262404', 'cui_str': 'Cerebellar degeneration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0007760', 'cui_str': 'Cerebellum Diseases'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0222045'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0460504,"There was a mean reduction in ataxia severity of 2.1 points (standard deviation 1.26) with four weeks of aerobic training, whereas ataxia severity increased by 0.3 (standard deviation 0.62) in the control group over the same period.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barbuto', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Martelli', 'Affiliation': 'Department of Mechanical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Isarime Babajide', 'Initials': 'IB', 'LastName': 'Omofuma', 'Affiliation': 'Department of Mechanical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sheng-Han', 'Initials': 'SH', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Mechanical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Seonjoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, Vagelos College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dell"", 'Affiliation': 'Department of Rehabilitation Medicine, Weill Cornell Medical College, Cornell University, New York, NY, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Rehabilitation Medicine, Weill Cornell Medical College, Cornell University, New York, NY, USA.'}]",Clinical rehabilitation,['10.1177/0269215520905073'] 539,31385858,Long-term Outcomes of Balloon Dilation for Persistent Eustachian Tube Dysfunction.,"OBJECTIVE To gather long-term follow-up data on the efficacy of balloon dilation for treating patients with persistent Eustachian tube dysfunction (ETD). STUDY DESIGN Extended follow-up study of the treatment arm of a prospective, multicenter, randomized controlled trial. SETTING Tertiary care academic center and private practice. PATIENTS Patients diagnosed with medically refractory persistent ETD. INTERVENTIONS Balloon dilation of the Eustachian tube. MAIN OUTCOME MEASURES The endpoints were the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score, revision dilation rate, changes in assessments of middle ear function, and patient satisfaction. RESULTS A total of 47 participants enrolled in the extended follow-up study. Mean follow-up was 29.4 months (range, 18-42 mo). There was a statistically significant mean (SD) change from baseline in the overall ETDQ-7 score (-2.5 ± 1.2; p < 0.0001). A reduction of one or more in their overall ETDQ-7 score was observed by 93.6% (44/47) participants. The revision dilation rate was 2.1% (1/47). Among participants with abnormal baseline middle ear assessments, 76.0% had normalized tympanic membrane position (p < 0.0001), 62.5% had normalization of tympanogram type (p < 0.001), and 66.7% had positive Valsalva maneuvers (p < 0.0001). Participant satisfaction was 83.0% at long-term follow-up. CONCLUSIONS Balloon dilation results in durable improvements in symptoms and middle ear assessments for patients with persistent Eustachian tube dysfunction at mean follow-up of longer than 2 years.",2019,"CONCLUSIONS Balloon dilation results in durable improvements in symptoms and middle ear assessments for patients with persistent Eustachian tube dysfunction at mean follow-up of longer than 2 years.","['patients with persistent Eustachian tube dysfunction at mean follow-up of longer than 2 years', '47 participants enrolled in the extended follow-up study', 'patients with persistent Eustachian tube dysfunction (ETD', 'Patients diagnosed with medically refractory persistent ETD', 'Tertiary care academic center and private practice']","['balloon dilation', 'Balloon Dilation', 'Balloon dilation of the Eustachian tube', 'Balloon dilation']","['7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score, revision dilation rate, changes in assessments of middle ear function, and patient satisfaction', 'normalized tympanic membrane position', 'symptoms and middle ear assessments', 'Participant satisfaction', 'overall ETDQ-7 score', 'positive Valsalva maneuvers', 'normalization of tympanogram type', 'revision dilation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271468', 'cui_str': 'Eustachian tube disorder (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0015183', 'cui_str': 'Pharyngotympanic Tube'}]","[{'cui': 'C0271468', 'cui_str': 'Eustachian tube disorder (disorder)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0457585', 'cui_str': 'Middle ear function (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0041445', 'cui_str': 'Eardrum'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042293', 'cui_str': 'Valsalva Maneuver'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",47.0,0.152302,"CONCLUSIONS Balloon dilation results in durable improvements in symptoms and middle ear assessments for patients with persistent Eustachian tube dysfunction at mean follow-up of longer than 2 years.","[{'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Cutler', 'Affiliation': 'Colorado Sinus Institute, Denver, Colorado.'}, {'ForeName': 'Ted A', 'Initials': 'TA', 'LastName': 'Meyer', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Shaun A', 'Initials': 'SA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': ""O'Malley"", 'Affiliation': 'Entellus Medical, Inc., Plymouth, Minnesota.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Thackeray', 'Affiliation': 'North American Science Associates (NAMSA), Minneapolis, Minnesota.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Slater', 'Affiliation': 'Austin Ear Clinic, Austin, Texas.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002396'] 540,30797396,Exploring the components of an efficacious computer brief intervention for reducing marijuana use among adults in the emergency department.,"OBJECTIVE To examine the efficacious components of a computer-delivered brief intervention (CBI) for reducing marijuana use among adults presenting to a low-income urban emergency department (ED), which a prior report found to decrease marijuana use at a 6-month follow-up. METHOD Participants were 237 ED patients reporting recent drug use (46% male; 54% African-American; mean age, 30.7) who were randomized to receive a CBI consisting of an interactive program guided by a virtual health counselor. The primary outcome was past 30-day marijuana use at 6-month follow-up assessed using the Timeline Follow-Back (TLFB). Intervention components related to change in marijuana use at 6 month follow-up examined in the current study included participant responses to items within five CBI domains that were rooted in motivational interviewing: goals for change, strengths, evoking-change (concerns about use and benefits of change), challenges, and tools for change. RESULTS The evoking-change domain was related to significant reductions in marijuana use at 6 months (B = -2.91, SE = 1.10, p < .01). Within this domain, items focused on concerns about family and friends were related to reductions in marijuana use of up to 5.5 fewer days of marijuana use in the past month (B = -5.49, SE = 1.63, p < .01). CONCLUSIONS An ED-based brief intervention, delivered by computer, was effective in reducing marijuana use. Intervention components focused on perceived concerns about use and benefits of change in relation to family and friends were critical domains within a CBI associated with reductions in marijuana use at 6-month follow-up.",2019,"Within this domain, items focused on concerns about family and friends were related to reductions in marijuana use of up to 5.5 fewer days of marijuana use in the past month (B = -5.49, SE = 1.63, p < .01). ","['Participants were 237 ED patients reporting recent drug use (46% male; 54% African-American; mean age, 30.7', 'adults presenting to a low-income urban emergency department (ED', 'adults in the emergency department']","['computer-delivered brief intervention (CBI', 'CBI consisting of an interactive program guided by a virtual health counselor']",['past 30-day marijuana use at 6-month follow-up assessed using the Timeline Follow-Back (TLFB'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0259095', 'cui_str': 'C(2)BI'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}]","[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4316909', 'cui_str': 'Marijuana Use'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",237.0,0.0249494,"Within this domain, items focused on concerns about family and friends were related to reductions in marijuana use of up to 5.5 fewer days of marijuana use in the past month (B = -5.49, SE = 1.63, p < .01). ","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Waller', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA 19104, USA; Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI 48109, USA. Electronic address: rwaller@sas.upenn.edu.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan School of Medicine, 2800 Plymouth Road, NCRC10-G080, Ann Arbor, MI 48109, USA; Institute for Healthcare Policy and Innovation, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Fernandez', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI 48109, USA; Institute for Healthcare Policy and Innovation, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan School of Medicine, 2800 Plymouth Road, NCRC10-G080, Ann Arbor, MI 48109, USA; Institute for Healthcare Policy and Innovation, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Chermack', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI 48109, USA; Center for Clinical Management Research, Ann Arbor Veterans Affairs Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan School of Medicine, 2800 Plymouth Road, NCRC10-G080, Ann Arbor, MI 48109, USA; Department of Emergency Medicine, University of Michigan School of Medicine, 1500 East Medical Center Drive, Ann Arbor, MI 48109, USA; Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights 3790A SPHI, Ann Arbor, MI 48109, USA; Department of Emergency Medicine, Hurley Medical Center, 1 Hurley Place, Flint, MI 48503, USA; Institute for Healthcare Policy and Innovation, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan School of Medicine, 2800 Plymouth Road, NCRC10-G080, Ann Arbor, MI 48109, USA; Institute for Healthcare Policy and Innovation, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI 48109, USA; Center for Clinical Management Research, Ann Arbor Veterans Affairs Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.014'] 541,32014493,The effect of weight loss on the progression of meniscal extrusion and size in knee osteoarthritis: a post-hoc analysis of the Intensive Diet and Exercise for Arthritis (IDEA) trial.,"OBJECTIVE Weight loss has beneficial effects on clinical outcomes in knee osteoarthritis (OA), but the mechanism is still unclear. Since meniscus extrusion is associated with knee pain, this study assessed whether weight loss by diet and/or exercise is associated with less progression in meniscus extrusion measures over time. DESIGN The Intensive Diet and Exercise for Arthritis trial (IDEA) was a prospective, single-blind, randomized-controlled trial including overweight and obese older adults with knee pain and radiographic OA. Participants were randomized to 18-month interventions: exercise only, diet only or diet + exercise. In a random subsample of 105 participants, MRIs were obtained at baseline and follow-up. The medial and lateral menisci were segmented and quantitative position and size measures were obtained, along with semiquantitative extrusion measures. Linear and log-binomial regression were used to examine the association between change in weight and change in meniscus measures. Between-group differences were analyzed using an analysis of covariance. RESULTS Weight loss was associated with less progression over time of medial meniscus extrusion as measured by the maximum (β: -24.59 μm, 95%CI: -41.86, -7.33) and mean (β: -19.08 μm, 95%CI: -36.47, -1.70) extrusion distances. No relationships with weight loss were observed for lateral meniscus position, medial or lateral meniscus size or semiquantitative measures. Change in meniscus position and size did not differ significantly between groups. CONCLUSIONS Weight loss was associated with beneficial modifications of medial meniscus extrusion over 18 months. This may be one of the mechanisms by which weight loss translates into a clinical benefit. CLINICAL TRIAL REGISTRATION NCT00381290.",2020,"No relationships with weight loss were observed for lateral meniscus position, medial or lateral meniscus size or semiquantitative measures.","['overweight and obese older adults with knee pain and radiographic OA', 'knee osteoarthritis (OA', 'knee osteoarthritis']","['interventions: exercise only, diet only or diet+exercise', 'Intensive Diet and Exercise']","['lateral meniscus position, medial or lateral meniscus size or semiquantitative measures', 'Weight loss', 'weight loss', 'Change in meniscus position and size', 'progression over time of medial meniscus extrusion']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0348072', 'cui_str': 'Menisci, Lateral'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2315938', 'cui_str': 'Genus Meniscus'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0348073', 'cui_str': 'Medial Menisci'}, {'cui': 'C0443213', 'cui_str': 'Extrusion (qualifier value)'}]",105.0,0.0667509,"No relationships with weight loss were observed for lateral meniscus position, medial or lateral meniscus size or semiquantitative measures.","[{'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Munugoda', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia. Electronic address: ishanka.munugoda@utas.edu.au.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistics and Data Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA. Electronic address: dbeavers@wakehealth.edu.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wirth', 'Affiliation': 'Institute of Anatomy, Department of Imaging and Functional Muskuloskelel Research; Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: wolfgang.wirth@pmu.ac.at.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Aitken', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia. Electronic address: Dawn.Aitken@utas.edu.au.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Loeser', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA. Electronic address: richard_loeser@med.unc.edu.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA. Electronic address: millergd@wfu.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lyles', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA. Electronic address: mlyles@wakehealth.edu.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: j.jeffrey.carr@vumc.org.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University Medical School, Boston, MA, USA; Boston Imaging Core Lab (BICL), Boston, MA, USA. Electronic address: Guermazi@bu.edu.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, University of Sydney, Sydney, Australia. Electronic address: david.hunter@sydney.edu.au.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA. Electronic address: messier@wfu.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Institute of Anatomy, Department of Imaging and Functional Muskuloskelel Research; Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.01.006'] 542,30730813,Morning exercise mitigates the impact of prolonged sitting on cerebral blood flow in older adults.,"Preventing declines in cerebral blood flow is important for maintaining optimal brain health with aging. We compared the effects of a morning bout of moderate-intensity exercise, with and without subsequent light-intensity walking breaks from sitting, on cerebral blood velocity over 8 h in older adults. In a randomized crossover trial, overweight/obese older adults ( n = 12, 70 ± 7 yr; 30.4 ± 4.3 kg/m 2 ), completed three acute conditions (6-day washout); SIT: prolonged sitting (8 h, control); EX+SIT: sitting (1 h), moderate-intensity walking (30 min), followed by uninterrupted sitting (6.5 h); and EX + BR: sitting (1 h), moderate-intensity walking (30 min), followed by sitting (6.5 h) interrupted with 3 min of light-intensity walking every 30 min. Bilateral middle cerebral artery velocities (MCAv) were determined using transcranial Doppler at 13 time points across the day. The temporal pattern and average MCAv over 8 h was determined. The pattern of MCAv over 8 h was a negative linear trend in SIT ( P < 0.001), but a positive quadratic trend in EX + SIT ( P < 0.001) and EX + BR ( P < 0.01). Afternoon time points in SIT were lower than baseline within condition ( P ≤ 0.001 for all). A morning dip in MCAv was observed in EX + SIT and EX + BR ( P < 0.05 relative to baseline), but afternoon time points were not significantly lower than baseline. The average MCAv over 8 h was higher in EX + SIT than SIT ( P = 0.007) or EX + BR ( P = 0.024). Uninterrupted sitting should be avoided, and moderate-intensity exercise should be encouraged for the daily maintenance of cerebral blood flow in older adults. The clinical implications of maintaining adequate cerebral blood flow include the delivery of vital oxygen and nutrients to the brain. NEW & NOTEWORTHY This is the first study to measure the combined effects of an exercise bout with breaks in sitting on cerebral blood velocity in older adults. Using frequent recordings over an 8-h period, we have performed a novel analysis of the pattern of cerebral blood velocity, adjusting for concurrent measures of mean arterial pressure and other potential confounders in a linear mixed effects regression.",2019,The average MCAv over 8 h was higher in EX + SIT than SIT ( P = 0.007) or EX + BR ( P = 0.024).,"['overweight/obese older adults ( n = 12, 70\u2009±\u20097 yr; 30.4\u2009±\u20094.3 kg/m 2 ), completed three acute conditions (6-day washout', 'older adults']","['morning bout of moderate-intensity exercise, with and without subsequent light-intensity walking breaks from sitting', 'exercise bout with breaks in sitting', 'SIT: prolonged sitting (8 h, control); EX+SIT: sitting (1 h), moderate-intensity walking (30 min), followed by uninterrupted sitting (6.5 h); and EX + BR: sitting (1 h), moderate-intensity walking (30 min), followed by sitting (6.5 h) interrupted with 3 min of light-intensity walking every 30 min']","['cerebral blood flow', 'EX + BR', 'Afternoon time points in SIT', 'afternoon time points', 'cerebral blood velocity', 'average MCAv', 'Bilateral middle cerebral artery velocities (MCAv', 'EX + SIT and EX + BR']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}]",,0.023302,The average MCAv over 8 h was higher in EX + SIT than SIT ( P = 0.007) or EX + BR ( P = 0.024).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wheeler', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia , Perth, Western Australia , Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia , Perth, Western Australia , Australia.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia , Perth, Western Australia , Australia.'}, {'ForeName': 'Kurt J', 'Initials': 'KJ', 'LastName': 'Smith', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia , Perth, Western Australia , Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University , Perth, Western Australia , Australia.'}, {'ForeName': 'Jaye', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia , Perth, Western Australia , Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia , Perth, Western Australia , Australia.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Heinonen', 'Affiliation': 'Turku PET Centre, University of Turku , Finland.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychiatry, University of Melbourne, Parkville, Melbourne, Victoria , Australia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'Baker Heart and Diabetes Institute , Melbourne, Victoria , Australia.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia , Vancouver, British Columbia , Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia , Perth, Western Australia , Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00001.2019'] 543,32154586,"Relations Between Acute Effects of Alcohol on Response Inhibition, Impaired Control over Alcohol Use, and Alcohol-Related Problems.","BACKGROUND Alcohol consistently impairs response inhibition in the laboratory, and alcohol impairment of response inhibition may lead to excess consumption or increases in intoxicated risk behavior, both of which contribute to risk for alcohol-related problems. To our knowledge, no prior studies have examined relations between alcohol impairment of response inhibition and either impaired control over alcohol (i.e., inability to adhere to predetermined drinking limits) or real-world alcohol-related problems. The current study addressed this gap in the literature. METHODS Young adult social drinkers (N = 215, 76% male) participated in a between-subjects, placebo-controlled alcohol challenge study and completed self-reports approximately 2 weeks later. Multilevel models were used to examine the hypothesis that alcohol impairment of response inhibition would indirectly lead to alcohol-related problems through impaired control over alcohol use. RESULTS Greater alcohol-induced impairment of response inhibition and impaired control over alcohol use were both significant predictors of alcohol-related problems. However, greater alcohol-induced response inhibition was not a significant predictor of impaired control over alcohol use. CONCLUSIONS To our knowledge, this is the first study demonstrating relationships between alcohol impairment of response inhibition and real-world alcohol-related problems and the first to address relationships between alcohol impairment of response inhibition and impaired control over alcohol use. These results suggest that impaired control over alcohol use may result from deficits in the trait ability to control behavior rather than deficits in alcohol-induced response inhibition. Regardless, results suggest that alcohol impairment of response inhibition and impaired control over alcohol are both worthwhile intervention targets.",2020,"However, greater alcohol-induced response inhibition was not a significant predictor of impaired control over alcohol use. ","['Young adult social drinkers (N=215, 76% Male) participated in a between-subjects, placebo-controlled alcohol challenge study and completed self-reports approximately two weeks later']",['Alcohol'],"['Response Inhibition, Impaired Control over Alcohol Use, and Alcohol-Related Problems', 'response inhibition']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0117678,"However, greater alcohol-induced response inhibition was not a significant predictor of impaired control over alcohol use. ","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Corbin', 'Affiliation': 'Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Berey', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Waddell', 'Affiliation': 'Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Leeman', 'Affiliation': 'University of Florida, Gainesville, Florida.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14322'] 544,32119972,Effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands; a randomized controlled trial.,"OBJECTIVE To evaluate the short-term effects of use of the dr. Bart app, compared to usual care, on the number of secondary health care consultations and clinical outcomes in people with knee/hip OA in the Netherlands. METHOD A randomized controlled design involving participants ≥50 years with self-reported knee and/or hip OA recruited from the community. The number of secondary health care consultations (primary outcome) and secondary outcomes were assessed at baseline, 3 and 6 months via online questionnaires. Data were analyzed using longitudinal mixed models, corrected for baseline values. Due to the design of this study, blinding of participants and researchers was not possible. RESULTS In total, 427 eligible participants were allocated to either the dr. Bart group (n = 214) or usual care (n = 213). We found no difference between groups in the number of secondary (i.e., orthopaedic surgeon, rheumatologist, or physician assistant) health care consultations (incidence rate ratio (IRR) 1.20 (95% CI: 0.67; 2.19)). We found positive treatment effects of the dr. Bart app on symptoms (2.6 (95% CI: 0.4; 4.9)), pain (3.5 (95% CI: 0.9; 6.0)), and activities of daily living (2.9 (95% CI: 0.2; 5.6)) on a 0-100 scale, higher score indicating less complaints, but not in any other secondary outcome. CONCLUSION The dr. Bart app did not change the number of secondary health care consultations compared to usual care. However, we found small positive effects (not clinically relevant) on pain, symptoms, and activities of daily living in people with knee/hip OA. TRIAL REGISTRATION Dutch Trial Register (Trial Number NTR6693/NL6505) (https://www.trialregister.nl/trial/6505).",2020,"Bart app, compared to usual care, on the number of secondary health care consultations and clinical outcomes in people with knee/hip OA in the Netherlands. ","['people with osteoarthritis of the knee and/or hip in the Netherlands', 'people with knee/hip OA in the Netherlands', '427 eligible participants', 'participants ≥50 years with self-reported knee and/or hip OA recruited from the community']",[],"['activities of daily living', 'pain', 'number of secondary (i.e. orthopaedic surgeon, rheumatologist, or physician assistant) health care consultations (incidence rate ratio (IRR', 'pain, symptoms, and activities of daily living']","[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0334891', 'cui_str': 'Orthopedists'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",427.0,0.19155,"Bart app, compared to usual care, on the number of secondary health care consultations and clinical outcomes in people with knee/hip OA in the Netherlands. ","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pelle', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: T.Pelle@maartenskliniek.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bevers', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands. Electronic address: K.Bevers@maartenskliniek.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Research Methodology, Measurement, and Data-Analysis, Behavioural, Management and Social Sciences, University of Twente, Enschede, The Netherlands; Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands. Electronic address: J.vanderPalen@mst.nl.'}, {'ForeName': 'F H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: F.vandenHoogen@maartenskliniek.nl.'}, {'ForeName': 'C H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: e.vandenende@maartenskliniek.nl.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.02.831'] 545,31935353,Effects of Geriatric Interdisciplinary Home Rehabilitation on Independence in Activities of Daily Living in Older People With Hip Fracture: A Randomized Controlled Trial.,"OBJECTIVE To evaluate the effects of early discharge followed by geriatric interdisciplinary home rehabilitation for older people with hip fracture on independence in activities of daily living (ADL) compared with inhospital geriatric care according to a multifactorial rehabilitation program. DESIGN Planned analysis of a randomized controlled trial with 3- and 12-month follow-ups. SETTING Geriatric ward, ordinary housing, and residential care facilities. PARTICIPANTS Of 466 people screened for eligibility, participants (N=205) with acute hip fracture, aged 70 years or older, including those with cognitive impairment and those living in residential care facilities, were randomized to intervention or control groups. INTERVENTION Individually designed interdisciplinary home rehabilitation for a maximum of 10 weeks. The intervention aimed at early hospital discharge and focused on prevention of falls, independence in daily activities, and walking ability indoors and outdoors. MAIN OUTCOME MEASURES Independence in ADL was measured using the Barthel ADL Index, and the ADL Staircase including the Katz ADL Index during hospital stay (prefracture performance) and at the follow-up visits in the participants' homes. RESULTS There were no significant differences in ADL performance between the groups, and they recovered their prefracture level of independence in personal and instrumental ADL comparably. At 12 months, 33 (41.3%) in the intervention group vs 33 (41.8%) in the control group (P=.99) had regained or improved their prefracture ADL performance according to the Barthel ADL Index, and 27 (37.0%) vs 36 (48.6%) according to the ADL Staircase (P=.207). CONCLUSIONS In older people with hip fracture, early discharge followed by geriatric interdisciplinary home rehabilitation resulted in a comparable recovery of independence in ADL at 3 and 12 months as inhospital geriatric care and rehabilitation.",2020,"There were no significant differences in ADL performance between the groups, and they recovered their pre-fracture level of independence in personal and instrumental ADLs comparably.","['older people with hip fracture, early discharge followed by geriatric interdisciplinary home rehabilitation', 'Of 466 people screened for eligibility, 205 participants with acute hip fracture, aged 70 or older, including those with cognitive impairment, and those living in residential care facilities', 'older people with hip fracture on independence in Activities of Daily Living (ADLs) compared with in-hospital geriatric care according to a multifactorial rehabilitation program', 'Older People with Hip Fracture', 'Geriatric ward, ordinary housing and residential care facilities', ""participants' homes""]","['geriatric interdisciplinary home rehabilitation', 'Geriatric Interdisciplinary Home Rehabilitation']","['ADL performance', 'pre-fracture ADL performance', 'Independence in Activities of Daily Living']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",205.0,0.126941,"There were no significant differences in ADL performance between the groups, and they recovered their pre-fracture level of independence in personal and instrumental ADLs comparably.","[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Karlsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden. Electronic address: asa.karlsson@umu.se.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lindelöf', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Olofsson', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden; Department of Surgical and Perioperative Science, Orthopedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Berggren', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stenvall', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.007'] 546,32132009,"Impact of a Telephonic Intervention to Improve Diabetes Control on Health Care Utilization and Cost for Adults in South Bronx, New York.","OBJECTIVE Self-management education and support are essential for improved diabetes control. A 1-year randomized telephonic diabetes self-management intervention (Bronx A1C) among a predominantly Latino and African American population in New York City was found effective in improving blood glucose control. To further those findings, this current study assessed the intervention's impact in reducing health care utilization and costs over 4 years. RESEARCH DESIGN AND METHODS We measured inpatient ( n = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014. Multilevel mixed modeling was used to assess changes in health care utilization and costs between the telephonic diabetes intervention (Tele/Pr) arm and print-only (PrO) control arm. RESULTS During follow-up, excess relative reductions in all-cause hospitalizations for the Tele/Pr arm compared with PrO arm were statistically significant for odds of hospital use (odds ratio [OR] 0.89; 95% CI 0.82, 0.97; P < 0.01), number of hospital stays (rate ratio [RR] 0.90; 95% CI 0.81, 0.99; P = 0.04), and hospital costs (RR 0.90; 95% CI 0.84, 0.98; P = 0.01). Reductions in hospital use and costs were even stronger for diabetes-related hospitalizations. These outcomes were not significantly related to changes observed in hemoglobin A 1c during individuals' participation in the 1-year intervention. CONCLUSIONS These results indicate that the impact of the Bronx A1C intervention was not just on short-term improvements in glycemic control but also on long-term health care utilization. This finding is important because it suggests the benefits of the intervention were long-lasting with the potential to not only reduce hospitalizations but also to lower hospital-associated costs.",2020,"These outcomes were not significantly related to changes observed in hemoglobin A 1c during individuals' participation in the 1-year intervention. ","['predominantly Latino and African American population in New York City', 'Adults in South Bronx, New York', 'inpatient ( n = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014']","['Bronx A1C intervention', 'Telephonic Intervention', 'telephonic diabetes intervention (Tele/Pr) arm and print-only control (PrO) arm', 'telephonic diabetes self-management intervention (Bronx A1C']","['Health Care Utilization and Cost', 'hospital use and costs', 'number of hospital stays', 'blood glucose control', 'glycemic control', 'health care utilization and costs', 'hospital costs']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}]","[{'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0255034,"These outcomes were not significantly related to changes observed in hemoglobin A 1c during individuals' participation in the 1-year intervention. ","[{'ForeName': 'Bahman P', 'Initials': 'BP', 'LastName': 'Tabaei', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY btabaei@health.nyc.gov.'}, {'ForeName': 'Renata E', 'Initials': 'RE', 'LastName': 'Howland', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Chamany', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Clyde B', 'Initials': 'CB', 'LastName': 'Schechter', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Winfred Y', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}]",Diabetes care,['10.2337/dc19-0954'] 547,32196514,Results from a cluster-randomized trial to evaluate a microfinance and peer health leadership intervention to prevent HIV and intimate partner violence among social networks of Tanzanian men.,"Despite calls to engage men in HIV and intimate partner violence (IPV) prevention efforts, effective approaches to reach and engage men in low-resource, high-HIV prevalence settings are limited. We identified and engaged social networks of mostly young men in a study designed to evaluate the efficacy of a combined microfinance and peer health leadership intervention to prevent HIV and IPV. We conducted a cluster-randomized trial among 60 social networks locally referred to as ""camps"" within Dar es Salaam, Tanzania. Camps were randomly assigned (1:1) to a microfinance and peer health leadership intervention or a control condition that received a brief delayed intervention after the study's conclusion. Allocation was not masked to participants or researchers. Behavioral assessments were conducted at baseline and 30-months post-intervention launch, with biological samples drawn at 30-months to test for sexually-transmitted infections (STIs). Primary outcomes included prevalence of STIs and past-year IPV perpetration. Secondary outcomes included STI sexual risk behaviors and past-year HIV testing. Proximal intervention targets included inequitable gender norm attitudes and hope. A modified Poisson regression approach was used to estimate intention-to-treat intervention effects on outcomes assessed at the 30-month follow-up. We enrolled 1,258 men within 60 camps. Of these men, 1,029 (81.8%) completed the 30-month follow-up. There were no differences by condition in STI prevalence, IPV perpetration, or sexual risk behaviors at the 30-month follow-up. Intervention participants reported greater levels of past-year HIV testing, controlling for baseline testing (aRR 1.13 95% CI 1.005-1.28). They also reported significantly lower levels of inequitable gender norm attitudes (adjusted effect -0.11, 95% CI -0.21-0.003). We successfully engaged and retained social networks of men in this multilevel intervention study. While we did not see an effect on the primary outcomes, our intervention successfully improved HIV testing and reduced inequitable gender norm attitudes.",2020,"While we did not see an effect on the primary outcomes, our intervention successfully improved HIV testing and reduced inequitable gender norm attitudes.","['mostly young men', '60 social networks locally referred to as ""camps"" within Dar es Salaam, Tanzania', 'HIV and intimate partner violence among social networks of Tanzanian men', 'We enrolled 1,258 men within 60 camps']","['combined microfinance and peer health leadership intervention', 'microfinance and peer health leadership intervention or a control condition that received a brief delayed intervention', 'microfinance and peer health leadership intervention', 'Proximal intervention']","['greater levels of past-year HIV testing, controlling for baseline testing', 'HIV testing and reduced inequitable gender norm attitudes', 'STI prevalence, IPV perpetration, or sexual risk behaviors', 'prevalence of STIs and past-year IPV perpetration', 'STI sexual risk behaviors and past-year HIV testing', 'levels of inequitable gender norm attitudes']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",1258.0,0.116286,"While we did not see an effect on the primary outcomes, our intervention successfully improved HIV testing and reduced inequitable gender norm attitudes.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Balvanz', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'H Luz', 'Initials': 'HL', 'LastName': 'McNaughton Reyes', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Mrema N', 'Initials': 'MN', 'LastName': 'Kilonzo', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Thespina J', 'Initials': 'TJ', 'LastName': 'Yamanis', 'Affiliation': 'School of International Service, American University, Washington, DC, United States of America.'}, {'ForeName': 'Basant', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Lusajo J', 'Initials': 'LJ', 'LastName': 'Kajula', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}]",PloS one,['10.1371/journal.pone.0230371'] 548,31904342,Association Between Exercise Capacity and Health-Related Quality of Life During and After Cardiac Rehabilitation in Acute Coronary Syndrome Patients: A Substudy of the OPTICARE Randomized Controlled Trial.,"OBJECTIVE To examine the strength of the association between exercise capacity and health-related quality of life (HRQOL) during and after cardiac rehabilitation (CR) in patients with acute coronary syndrome (ACS) who completed CR. DESIGN Prospective cohort study. SETTING Outpatient CR center. PARTICIPANTS Patients (N=607) with ACS who completed CR. INTERVENTIONS Multidisciplinary 12-week exercise-based CR program. MAIN OUTCOME MEASURES At baseline (pre-CR), the 6-Minute Walk Test (6MWT) was performed to determine exercise capacity, and the MacNew Heart Disease Health-related Quality of Life questionnaire was used to assess HRQOL. Measurements were repeated immediately after completion of CR (post-CR): at 12 months and 18 months follow-up. Multivariable linear regression, including an interaction term for time and exercise capacity, was applied to study the association between exercise capacity and HRQOL at different time points relative to CR, whereas model parameters were estimated by methods that accounted for dependency of repeated observations within individuals. RESULTS Mean age in years ± SD was 58±8.9 and 82% of participants were male. Baseline mean 6MWT distance in meters ± SD was 563±77 and median (25th-75th percentile) global HRQOL was 5.5 (4.6-6.1) points. Mean 6MWT distance (P<.001) and the global (P<.001), physical (P<.001), emotional (P<.001) and social (P<.001) domains of HRQOL improved significantly during CR and continued to improve during follow-up post-CR. Independent of the timing relative to CR (ie, pre-CR, post-CR, or during follow-up), a difference of 10 m 6MWT distance was associated with a mean difference in the global HRQOL domain of 0.007 (95% confidence interval [CI], 0.001-0.014) points (P=.029) and a mean difference in the physical domain of 0.009 (95% CI, 0.001-0.017) points (P=.023). CONCLUSIONS Better exercise capacity was significantly associated with higher scores on the global and physical domains of HRQOL, irrespective of the timing relative to CR, albeit these associations were weak. Hence, CR programs in secondary prevention should continue to aim at enhancing both HRQOL and exercise capacity.",2020,"Mean 6MWT distance(P<0.001) and the global(P<0.001), physical(P<0.001), emotional(P<0.001) and social(P<0.001) domains of HRQOL improved significantly during CR and continued to improve during follow-up post-CR.","['Mean(standard deviation) age was 58(8.9) years and 82% were male', 'Patients(N=607) with ACS who completed CR', 'Acute Coronary Syndrome Patients', 'Outpatient CR center', 'patients with acute coronary syndrome (ACS), who completed CR']","['cardiac rehabilitation (CR', 'Multidisciplinary 12-week exercise-based CR program']","['exercise capacity, and the MacNew Heart Disease Health-related Quality of Life questionnaire', 'global HRQOL', 'At baseline(pre-CR), the six-minute walk test(6MWT', 'Mean 6MWT distance(P<0.001) and the global(P<0.001), physical(P<0.001), emotional(P<0.001) and social(P<0.001) domains of HRQOL', 'Exercise Capacity and Health-Related Quality of Life']","[{'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",607.0,0.127582,"Mean 6MWT distance(P<0.001) and the global(P<0.001), physical(P<0.001), emotional(P<0.001) and social(P<0.001) domains of HRQOL improved significantly during CR and continued to improve during follow-up post-CR.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Bakker', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam. Electronic address: m.debakker@erasmusmc.nl.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'den Uijl', 'Affiliation': 'Capri Cardiac Rehabilitation Rotterdam, Rotterdam; Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Ter Hoeve', 'Affiliation': 'Capri Cardiac Rehabilitation Rotterdam, Rotterdam; Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'van Domburg', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Geleijnse', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam.'}, {'ForeName': 'Rita J', 'Initials': 'RJ', 'LastName': 'van den Berg-Emons', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Sunamura', 'Affiliation': 'Capri Cardiac Rehabilitation Rotterdam, Rotterdam.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.11.017'] 549,31874153,Effect of Telenursing and Face-to-Face Training Techniques on Quality of Life in Burn Patients: A Clinical Trial.,"OBJECTIVE To compare the effect of telenursing and face-to-face training on the quality of life (QOL) of patients with a burn injury. DESIGN This clinical trial with pretest-posttest design on 3 groups was conducted in Kermanshah, Iran, from 2017 to 2018. Convenience sampling was used. SETTING A tertiary hospital in Kermanshah, west of Iran. PARTICIPANTS A total of 90 patients with burns of grade 2 and 3 after discharge from the hospital were randomly assigned to 3 groups including telenursing (30), face-to-face training (30), and control (30). INTERVENTIONS Each intervention group received 1-on-1 telephone training and face-to-face training in 8 sessions (2 sessions of 15 to 20min/wk). The control group received regular care. MAIN OUTCOME MEASURES QOL was evaluated by the Burn Specific Health Scale-Brief (BSHS-B). RESULTS The mean BSHS-B scores before and after intervention for telenursing, face-to-face, and the control group were 71.43±21.92 and 133.06±11.97; 64.83±26.16 and 124.83±23.05; and 58.63±20.89 and 73.13±33.04, respectively. There was a statistically significant difference among the 3 groups with respect to the training methods after intervention (P<.001). In addition, post hoc test did not show a significant difference between the telenursing and face-to-face groups (P=.244). CONCLUSIONS Educational methods in the form of telenursing and face-to-face training were effective and promoted QOL in survivors of burn injuries. Both telenursing and face-to-face training can be used to improve the QOL of survivors of burn injuries during the rehabilitation phase.",2020,Both telenursing and face-to-face training can be used to improve the quality of life of burn survivors during rehabilitation phase.,"['A total of 90 burn patients with grade 2 and 3 after discharge from hospital', 'burn patients', 'three groups was conducted in Kermanshah (Iran) from 2017 to 2018', 'a tertiary hospital at Kermanshah, west of Iran']","['one-on-one telephone training and face-to-face training', 'tele-nursing and face-to-face training techniques', 'telenursing and face-to-face training', 'face-to-face training (30) and control (30', 'regular care']","['quality of life', 'mean BSHS-B scores', 'Burn Specific Health Scale-Brief (BSHS-B', 'quality of life of burn survivors', 'Quality of life', 'quality of life of burn injured']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",90.0,0.0248646,Both telenursing and face-to-face training can be used to improve the quality of life of burn survivors during rehabilitation phase.,"[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Nursing Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Rostam', 'Initials': 'R', 'LastName': 'Jalali', 'Affiliation': 'Department of Nursing, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: ks_jalali@yahoo.com.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Heydarikhayat', 'Affiliation': 'Nursing Department, Iranshahr University of Medical Sciences, Iranshahr, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Salari', 'Affiliation': 'Biostatistics Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.10.197'] 550,31912202,The influence of time to adrenaline administration in the Paramedic 2 randomised controlled trial.,"PURPOSE To examine the time to drug administration in patients with a witnessed cardiac arrest enrolled in the Pre-Hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest (PARAMEDIC2) randomised controlled trial. METHODS The PARAMEDIC2 trial was undertaken across 5 NHS ambulance services in England and Wales with randomisation between December 2014 and October 2017. Patients with an out-of-hospital cardiac arrest who were unresponsive to initial resuscitation attempts were randomly assigned to 1 mg intravenous adrenaline or matching placebo according to treatment packs that were identical apart from treatment number. Participants and study staff were masked to treatment allocation. RESULTS 8016 patients were enrolled, 4902 sustained a witnessed cardiac arrest of whom 2437 received placebo and 2465 received adrenaline. The odds of return of spontaneous circulation decreased in both groups over time but at a greater rate in the placebo arm odds ratio (OR) 0.93 (95% CI 0.92-0.95) compared with the adrenaline arm OR 0.96 (95% CI 0.95-0.97); interaction OR: 1.03, 95% CI 1.01-1.05, p = 0.005. By contrast, although the rate of survival and favourable neurological outcome decreased as time to treatment increased, the rates did not differ between the adrenaline and placebo groups. CONCLUSION The rate of return of spontaneous circulation, survival and favourable neurological outcomes decrease over time. As time to drug treatment increases, adrenaline increases the chances of return of spontaneous circulation. Longer term outcomes were not affected by the time to adrenaline administration. (ISRCTN73485024).",2020,The odds of return of spontaneous circulation decreased in both groups over time but at a greater rate in the placebo arm odds ratio (OR) 0.93 (95% CI 0.92-0.95) compared with the adrenaline arm OR 0.96,"['8016 patients were enrolled, 4902 sustained a witnessed cardiac arrest of whom 2437 received', 'patients with a witnessed cardiac arrest enrolled in the Pre-Hospital Assessment of the Role of', '5 NHS ambulance services in England and Wales with randomisation between December 2014 and October 2017', 'Patients with an out-of-hospital cardiac arrest who were unresponsive to initial resuscitation attempts']","['adrenaline or matching placebo', 'adrenaline', 'placebo', 'Adrenaline']","['rate of return of spontaneous circulation, survival', 'chances of return of spontaneous circulation', 'rate of survival and favourable neurological outcome', 'odds of return of spontaneous circulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.40833,The odds of return of spontaneous circulation decreased in both groups over time but at a greater rate in the placebo arm odds ratio (OR) 0.93 (95% CI 0.92-0.95) compared with the adrenaline arm OR 0.96,"[{'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK. paramedic@warwick.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kenna', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Scomparin', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Fothergill', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Gunson', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, West Midlands, DY5 1LX, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pocock', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': ""O'Shea"", 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Finn', 'Affiliation': 'Curtin University, Perth, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}]",Intensive care medicine,['10.1007/s00134-019-05836-2'] 551,31778659,Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions.,"OBJECTIVE To determine demographic and physiological factors that predict improvement in aerobic capacity among individuals with chronic stroke participating in cycling interventions. DESIGN Secondary analysis of data from 2 randomized clinical trials. SETTING Research laboratory. PARTICIPANTS Individuals with chronic stroke (N=44). INTERVENTIONS Participants were randomized to one of the following interventions: forced aerobic exercise and upper extremity repetitive task practice (FE+UERTP, n=16), voluntary aerobic exercise and upper extremity repetitive task practice (VE+UERTP, n=15), or a nonaerobic control group (control, n=13). All interventions were time-matched and occurred 3 times per week for 8 weeks. MAIN OUTCOME MEASURE Aerobic capacity as measured by peak oxygen consumption per unit time (VO 2peak ) during maximal cardiopulmonary exercise stress testing. RESULTS Significant improvements in VO 2peak were observed from baseline to postintervention in the VE+UERTP group (P<.001). Considerable variability was observed among participants relating to postintervention change in VO 2peak . Among aerobic exercise participants, a multivariate regression analysis revealed that cycling cadence, baseline VO 2peak , and group allocation were significant predictors of change in VO 2peak . CONCLUSIONS High exercise rate (cycling cadence) appears to be an important variable in improving aerobic capacity and should be considered when prescribing aerobic exercise for individuals with chronic stroke. Those with low VO 2peak at baseline may benefit the most from aerobic interventions as it relates to cardiorespiratory fitness. Further investigation is warranted to understand the precise role of other exercise and demographic variables in the prescription of aerobic exercise for this population and their effects on secondary stroke prevention and mortality.",2020,"RESULTS Significant improvements in VO 2 peak were observed from baseline to post-intervention in the VE+RTP group (p<0.001).","['Individuals with chronic stroke (N=44', 'individuals with chronic stroke participating in cycling interventions', 'individuals with chronic stroke']","['High exercise rate (cycling cadence', 'aerobic exercise', 'interventions: forced-rate aerobic exercise and upper extremity repetitive task practice (FE+RTP, n=16), voluntary-rate aerobic exercise and upper extremity repetitive task practice (VE+RTP, n=15), or a non-aerobic control', 'VE+RTP']","['peak oxygen consumption (VO 2peak ', 'aerobic capacity', 'VO 2 peak']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",,0.116552,"RESULTS Significant improvements in VO 2 peak were observed from baseline to post-intervention in the VE+RTP group (p<0.001).","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Linder', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio; Concussion Center, Cleveland Clinic, Cleveland, Ohio; Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, Ohio. Electronic address: linders@ccf.org.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'Concussion Center, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Rosenfeldt', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Penko', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mandy Miller', 'Initials': 'MM', 'LastName': 'Koop', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Phelan', 'Affiliation': 'Sports Cardiology Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio; Concussion Center, Cleveland Clinic, Cleveland, Ohio; Center for Neurologic Restoration, Cleveland Clinic, Cleveland, Ohio.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.10.187'] 552,32222367,"A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.","PURPOSE To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis. DESIGN Randomized, double-masked, multicenter, phase 3 clinical trial. METHODS Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits. RESULTS Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity). CONCLUSION In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.",2020,"Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively","['Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis', 'Acute Bacterial Conjunctivitis', 'subjects with bacterial conjunctivitis', '526 subjects', '753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [N = 324]; PVP-I [N = 108]; placebo [N = 321]); mean (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1']","['placebo', 'Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension', 'PVP-I/DEX, PVP-I 0.6% alone, or placebo', 'DEX', 'topical ophthalmic suspension combination of povidone-iodine (PVP-I; 0.6%) and dexamethasone (DEX']","['bacterial eradication', 'efficacy and safety', 'Adverse events (AEs', 'clinical resolution', 'mean treatment compliance', 'clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0009768', 'cui_str': 'Conjunctivitis, Mucopurulent'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0976129', 'cui_str': 'dexamethasone 0.1 % Ophthalmic Suspension'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0991532', 'cui_str': 'Ophthalmic Suspension'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",753.0,0.425662,"Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Ta', 'Affiliation': 'Stanford University School of Medicine, Byers Eye Institute at Stanford, Palo Alto, California, USA. Electronic address: cta@stanford.edu.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Raizman', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gross', 'Affiliation': 'Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Sunir', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Pinnacle Research Institute, Fort Lauderdale, Florida, USA.'}, {'ForeName': 'Sushanta', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Shire, A Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shire, A Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Segal', 'Affiliation': 'Private Practice, Delray Beach, Florida, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.03.018'] 553,32220283,"Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial.","BACKGROUND The Butantan Institute has manufactured a lyophilised tetravalent live-attenuated dengue vaccine Butantan-DV, which is analogous to the US National Institutes of Health (NIH) TV003 admixture. We aimed to assess the safety and immunogenicity of Butantan-DV. METHODS We did a two-step, double-blind, randomised placebo-controlled phase 2 trial at two clinical sites in São Paulo, Brazil. We recruited healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded. Step A was designed as a small bridge-study between Butantan-DV and TV003 in DENV-naive participants. In step A, we planned to randomly assign 50 dengue virus (DENV)-naive individuals to receive two doses of Butantan-DV, TV003, or placebo, given 6 months apart. In step B, we planned to randomly assign 250 participants (DENV-naive and DENV-exposed) to receive one dose of Butantan-DV or placebo. Participants were randomly assigned, by computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo. Participants and study staff were unaware of treatment allocation. The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat. The primary immunogenicity outcome was seroconversion rates of the DENV-1-4 serotypes measured 91 days after the first vaccination, analysed in the per-protocol population, which included all participants in step A, and all participants included in step B who completed all study visits with serology sample collection. This trial is registered with ClinicalTrials.gov, NCT01696422. FINDINGS Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants. Of the 155 DENV-naive participants, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received placebo. Of the 145 DENV-exposed participants, 113 (78%) received Butantan-DV, three (2%) received TV003, and 29 (20%) received placebo. Butantan-DV and TV003 were both immunogenic, well-tolerated, and no serious adverse reactions were observed. In step A, rash was the most frequent adverse event (16 [845] of 19 participants in the Butantan-DV group and 13 [76%] of 17 participants in the TV003 group). Viraemia was similar between the Butantan-DV and TV003 groups. Of the 85 DENV-naive participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis and thus were included in the per-protocol analysis population, 74 (87%) achieved seroconversion to DENV-1, 78 (92%) to DENV-2, 65 (76%) to DENV-3, and 76 (89%) to DENV-4. Of the 101 DENV-exposed participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis, 82 (81%) achieved seroconversion to DENV-1, 79 (78%) to DENV-2, 83 (82%) to DENV-3, and 78 (77%) to DENV-4. INTERPRETATION Butantan-DV and TV003 were safe and induced robust, balanced neutralising antibody responses against the four DENV serotypes. Efficacy evaluation of the Butantan-DV vaccine is ongoing. FUNDING Intramural Research Program US NIH National Institute of Allergy and Infectious Diseases, Brazilian National Bank for Economic and Social Development, Fundação de Amparo à Pesquisa do Estado de São Paulo, and Fundação Butantan.",2020,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","['healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded', 'adults in Brazil', 'Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants']","['placebo', 'Butantan-DV or placebo', 'Butantan-DV, TV003, or placebo', 'tetravalent, live-attenuated dengue vaccine Butantan-DV', 'computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo', 'Butantan-DV vaccine']","['Safety and immunogenicity', 'Viraemia', 'seroconversion to DENV-1', 'frequency of solicited and unsolicited local and systemic adverse reactions', 'seroconversion rates of the DENV-1-4 serotypes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0580278', 'cui_str': '4 serotype'}]",300.0,0.486172,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","[{'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexander Roberto', 'Initials': 'AR', 'LastName': 'Precioso', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil; Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil. Electronic address: alexander.precioso@butantan.gov.br.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Thomé', 'Affiliation': 'Preventive Medicine Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Patrícia Emília', 'Initials': 'PE', 'LastName': 'Braga', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Tazio', 'Initials': 'T', 'LastName': 'Vanni', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Lúcia M A', 'Initials': 'LMA', 'LastName': 'Campos', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Mondini', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Graça Salomão', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'da Silva', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Heloisa M', 'Initials': 'HM', 'LastName': 'Espinola', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Joane', 'Initials': 'J', 'LastName': 'do Prado Santos', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Cecilia L S', 'Initials': 'CLS', 'LastName': 'Santos', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'Maria do Carmo S T', 'Initials': 'MDCST', 'LastName': 'Timenetsky', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'João Luiz', 'Initials': 'JL', 'LastName': 'Miraglia', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Neuza M F', 'Initials': 'NMF', 'LastName': 'Gallina', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weiskopf', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sette', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Raphaella', 'Initials': 'R', 'LastName': 'Goulart', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rafael Tavares', 'Initials': 'RT', 'LastName': 'Salles', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alvino', 'Initials': 'A', 'LastName': 'Maestri', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Adriana Maluf Elias', 'Initials': 'AME', 'LastName': 'Sallum', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sylvia Costa Lima', 'Initials': 'SCL', 'LastName': 'Farhat', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Neusa K', 'Initials': 'NK', 'LastName': 'Sakita', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana C O A', 'Initials': 'JCOA', 'LastName': 'Ferreira', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cassia G T', 'Initials': 'CGT', 'LastName': 'Silveira', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Priscilla R', 'Initials': 'PR', 'LastName': 'Costa', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isaias', 'Initials': 'I', 'LastName': 'Raw', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Kalil', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30023-2'] 554,31926142,Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial.,"OBJECTIVE To analyze the acute hemodynamic effects of adding virtual reality-based therapy (VRBT) using exergames for patients undergoing cardiac rehabilitation (CR). DESIGN Crossover trial. SETTING Outpatient rehabilitation center. PARTICIPANTS Patients (N=27) with a diagnosis of cardiovascular disease or cardiovascular risk factors. Mean age (years) ± SD was 63.4±12.7 and mean body mass index (kg/m2) ± SD was 29.0±4.0. INTERVENTIONS Patients performed 1 VRBT session and 1 CR session on 2 nonconsecutive days. Each session comprised an initial rest, warm-up, conditioning, and recovery. During warm-up, in the VRBT session, games were performed with sensors to reproduce the movements of avatars and, in the CR session, patients were required to reproduce the movements of the physiotherapists. In the conditioning phase for VRBT, games were also played with motion sensors, dumbbells, and shin guards. The CR session consisted of exercises performed on a treadmill. The intensity of training was prescribed by heart rate reserve (HRR; 40%-70%). MAIN OUTCOME MEASURES The primary outcomes were heart rate, blood pressure, respiratory rate (RR), rating of perceived exertion (RPE), and peripheral oxygen saturation, evaluated before, during, and after the VRBT or CR session on 2 nonconsecutive days. The secondary outcome was to evaluate whether the patients achieved the prescribed HRR and the percentage of time they maintained this level during the VRBT session. RESULTS VRBT produces a physiological similar pattern of acute hemodynamic effects in CR. However, there was greater magnitude of heart rate, RR, and RPE (P<.01) during the execution of VRBT and until 5 minutes of recovery, observed at the moments of rest, and 1, 3, and 5 minutes of recovery. CONCLUSIONS Although the VRBT session produces similar physiological acute hemodynamic effects in CR, greater magnitudes of heart rate, RR, and RPE were observed during its execution and up to 5 minutes after the session.",2020,"However, there was greater magnitude of HR, RR, and RPE (p<0.01) during the execution of VRBT and until 5 minutes of recovery, observed at the moments of rest, and the 1st, 3rd, and 5th minutes of recovery. ","['patients of cardiovascular rehabilitation', 'outpatient rehabilitation center', 'patients (n=27, 63.4±12.7y, 29.0±4.0kg/m2) with a diagnosis of cardiovascular disease or cardiovascular risk factors', 'cardiac patients undergoing CR']","['VRBT session and one CR session', 'virtual reality based-therapy', 'VRBT', 'VRBT session']","['prescribed HRR and the percentage of time they maintained this level during the VRBT session', 'heart rate (HR), blood pressure, respiratory rate (RR), rating of perceived exertion (RPE), and peripheral oxygen saturation, evaluated before, during, and after the VRBT or CR session', 'magnitude of HR, RR, and RPE (p<0.01', 'magnitudes of HR, RR, and RPE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}]",,0.0844307,"However, there was greater magnitude of HR, RR, and RPE (p<0.01) during the execution of VRBT and until 5 minutes of recovery, observed at the moments of rest, and the 1st, 3rd, and 5th minutes of recovery. ","[{'ForeName': 'Mayara Moura', 'Initials': 'MM', 'LastName': 'Alves da Cruz', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil. Electronic address: maya_bilac@hotmail.com.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Ricci-Vitor', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Giovanna Lombardi', 'Initials': 'GL', 'LastName': 'Bonini Borges', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fernanda da Silva', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'Marques Vanderlei', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.006'] 555,32221819,Voluntary Vs Nominated Peer Educators: a Randomized Trial within the NoTrap! Anti-Bullying Program.,"There is a debate in scientific literature about the effectiveness of a peer-led approach to anti-bullying interventions. In order to understand which circumstances and for whom these approaches work best, the present study was carried out within the NoTrap! anti-bullying program. Using a cluster design, classes were randomly assigned into two different peer educator recruitment strategies: volunteering (N = 500; 48% females; mean age = 13.5 years, ds = 1.3) vs peer nominated (N = 466; 38% females; mean age = 13.9 years, ds = 1.3). Results showed that voluntary peer educators suffered a higher level of victimization, while the nominated ones tended to be more popular and likable. Furthermore, a set of linear mixed-effect models showed that the program was effective in reducing bullying and victimization, and in increasing defending behaviour only in the voluntary recruitment condition. On the contrary, in classrooms under the peer nominated recruitment condition, bullying and victimization remained stable, and defending behaviour increased only for peer educators, but not for their classmates. This implies that the step of peer selection and recruitment must be kept into consideration in developing and validating an intervention, because of its possible impact on the effectiveness of the whole intervention.",2020,"Furthermore, a set of linear mixed-effect models showed that the program was effective in reducing bullying and victimization, and in increasing defending behaviour only in the voluntary recruitment condition.","['N\u2009=\u2009500; 48% females; mean age\u2009=\u200913.5\xa0years, ds\u2009=\u20091.3) vs peer nominated (N\u2009=\u2009466; 38% females; mean age\u2009=\u200913.9\xa0years, ds\u2009=\u20091.3']","['Voluntary Vs Nominated Peer Educators', 'peer educator recruitment strategies: volunteering']",['level of victimization'],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",,0.0193506,"Furthermore, a set of linear mixed-effect models showed that the program was effective in reducing bullying and victimization, and in increasing defending behaviour only in the voluntary recruitment condition.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zambuto', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy.'}, {'ForeName': 'Benedetta Emanuela', 'Initials': 'BE', 'LastName': 'Palladino', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy. benedettaemanuela.palladino@unifi.it.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Nocentini', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Menesini', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01108-4'] 556,31812510,"Effects of Belapectin, an Inhibitor of Galectin-3, in Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension.","BACKGROUND & AIMS Increased levels of galectin 3 have been associated with nonalcoholic steatohepatitis (NASH) and contribute to toxin-induced liver fibrosis in mice. GR-MD-02 (belapectin) is an inhibitor of galectin 3 that reduces liver fibrosis and portal hypertension in rats and was safe and well tolerated in phase 1 studies. We performed a phase 2b, randomized trial of the safety and efficacy of GR-MD-02 in patients with NASH, cirrhosis, and portal hypertension. METHODS Patients with NASH, cirrhosis, and portal hypertension (hepatic venous pressure gradient [HVPG] ≥ 6 mm Hg) from 36 centers were randomly assigned, in a double-blind manner, to groups that received biweekly infusions of belapectin 2 mg/kg (n = 54), 8 mg/kg (n = 54), or placebo (n = 54) for 52 weeks. The primary endpoint was change in HVPG (Δ HVPG) at the end of the 52-week period compared with baseline. Secondary endpoints included changes in liver histology and development of liver-related outcomes. RESULTS We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0). Belapectin had no significant effect on fibrosis or nonalcoholic fatty liver disease activity score, and liver-related outcomes did not differ significantly among groups. In an analysis of a subgroup of patients without esophageal varices at baseline (n = 81), 2 mg/kg belapectin was associated with a reduction in HVPG at 52 weeks compared with baseline (P = .02) and reduced development of new varices (P = .03). Belapectin (2 mg/kg) was well tolerated and produced no safety signals. CONCLUSIONS In a phase 2b study of 162 patients with NASH, cirrhosis, and portal hypertension, 1 year of biweekly infusion of belapectin was safe but not associated with significant reduction in HVPG or fibrosis compared with placebo. However, in a subgroup analysis of patients without esophageal varices, 2 mg/kg belapectin did reduce HVPG and development of varices. ClinicalTrials.gov number: NCT02462967.",2020,"We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0).","['Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension', '6 mm Hg) from 36 centers', 'Patients with NASH, cirrhosis, and portal hypertension (hepatic venous pressure gradient', '162 patients with NASH, cirrhosis, and portal hypertension', 'patients with NASH, cirrhosis, and portal hypertension']","['HVPG', 'placebo', 'belapectin', 'Belapectin', 'GR-MD-02 (belapectin', 'GR-MD-02']","['liver fibrosis and portal hypertension', 'HVPG or fibrosis', 'ΔHVPG', 'esophageal varices', 'HVPG and development of varices', 'HVPG', 'fibrosis or nonalcoholic fatty liver disease activity score, and liver-related outcomes', 'changes in liver histology and development of liver-related outcomes', 'change in HVPG (-28', 'reduced development of new varices', 'tolerated and produced no safety signals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",162.0,0.533553,"We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0).","[{'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: nchalasa@iu.edu.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Garcia-Tsao', 'Affiliation': 'Yale University, New Haven, Colorado.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Vuppalanchi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, San Antonio, Texas.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Cedar Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Maxmillan', 'Initials': 'M', 'LastName': 'Pyko', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Richmond and Newport News, Virginia.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Allgood', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Shlevin', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Rex', 'Initials': 'R', 'LastName': 'Horton', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Zomer', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Irish', 'Affiliation': 'East Carolina University, Greenville, South Carolina.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Research Institute, San Antonio, Texas.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Traber', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2019.11.296'] 557,31830433,Two Weeks of Wearing a Knee Brace Compared With Minimal Intervention on Kinesiophobia at 2 and 6 Weeks in People With Patellofemoral Pain: A Randomized Controlled Trial.,"OBJECTIVE To investigate the effect of a knee brace compared with minimal intervention on self-reported kinesiophobia and function, objective function, and physical activity level in people with patellofemoral pain (PFP). DESIGN Single-blind randomized controlled trial (1:1), parallel. PARTICIPANTS Individuals with PFP (N=50). MAIN OUTCOME MEASURES Primary: kinesiophobia (Tampa Scale for Kinesiophobia). Secondary: self-reported function (Anterior Knee Pain Scale), physical activity level (International Physical Activity Questionnaire), and objective function (forward step-down test). Outcomes were assessed at baseline (T 0 ), at the end of the intervention (2wk) (T 1 ), and at 6 weeks after baseline (T 2 ). INTERVENTION Participants were randomly assigned to 1 of 2 interventions groups: (1) use of knee brace for 2 weeks during daily living, sports, or painful tasks (brace group) and (2) educational leaflet with information about PFP (leaflet group). RESULTS The knee brace reduced kinesiophobia in people with PFP compared with minimal intervention with moderate effect size at T 1 =mean difference (95% CI) -5.56 (-9.18 to -1.93) and T 2 =-5.24 (-8.58 to -1.89). There was no significant difference in self-reported and objective function and physical activity level. CONCLUSIONS The knee brace improved kinesiophobia immediately after intervention (at 2wk) and at 6-week follow-up in people with PFP compared with minimal intervention. A knee brace may be considered within clinically reasoned paradigms to facilitate exercise therapy interventions for people with PFP.",2020,The knee brace reduced kinesiophobia in people with PFP compared with minimal intervention with moderate effect size at T 1 =mean difference (95% CI),"['people with PFP', 'people with patellofemoral pain (PFP', 'Individuals with PFP (N=50', 'People With Patellofemoral Pain']","['Wearing a Knee Brace Compared With Minimal Intervention on Kinesiophobia', 'knee brace for 2 weeks during daily living, sports, or painful tasks (brace group) and (2) educational leaflet with information about PFP (leaflet group', 'minimal intervention', 'knee brace']","['self-reported and objective function and physical activity level', 'self-reported kinesiophobia and function, objective function, and physical activity level', 'Secondary: self-reported function (Anterior Knee Pain Scale), physical activity level (International Physical Activity Questionnaire), and objective function (forward step-down test']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.11886,The knee brace reduced kinesiophobia in people with PFP compared with minimal intervention with moderate effect size at T 1 =mean difference (95% CI),"[{'ForeName': 'Liliam B', 'Initials': 'LB', 'LastName': 'Priore', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lack', 'Affiliation': 'Sports and Exercise Medicine, William Harvey Research Institute, School of Medicine and Dentistry, Queen Mary University London, London, United Kingdom.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Fabio M', 'Initials': 'FM', 'LastName': 'Azevedo', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'de Oliveira Silva', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil; La Trobe Sport and Exercise Medicine Research Centre (LASEM), School of Allied Health, La Trobe University, Melbourne, Australia. Electronic address: danilo110190@hotmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.10.190'] 558,31319970,"Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors: A multicenter, randomized, phase 3 trial.","OBJECTIVES Considering the frequent expression of somatostatine receptors, we designed the G04.2011 trial to investigate the efficacy of the somatostatine analogue lanreotide in maintenance for SCLC patients after response to standard treatment. MATERIALS AND METHODS A multicenter, randomized, phase 3 trial was conducted in SCLC expressing somatostatine receptors at baseline Octreoscan, responding after platinum-based chemotherapy with/without radiotherapy. Patients were randomized 1:1 to receive maintenance lanreotide 120 mg subcutaneously every 28 days, up to 1 year or progression versus observation. Randomization was stratified according to stage (limited/extended, LD/ED). The primary end-point was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety. RESULTS Seventy-one patients were randomly assigned (39 to lanreotide, 32 to observation) in 9 Italian institutions. Median PFS was 3.6 (95% CI 3.2-3.9) with lanreotide versus 2.3 months (95% CI 1.7-2.9) with observation (HR 1.51, 95% CI 0.90-2.50; P = 0.11). Stage was an independent predictor for PFS (HR 3.14, 95% CI 1.77-5.57; P < 0.0001). Median PFS was 7.0 (95% CI <1-13.5) with lanreotide versus 3.8 months (95% CI <1-8.6) with observation in LD (P = 0.21), and 3.0 (95% CI 2.2-3.8) versus 2.2 (95% 1.7-2.7) in ED (P = 0.19). Median OS was 9.5 (95% CI 4.8-14.3) with lanreotide versus 4.7 months (95% CI <1-16.6) with observation (P = 0.47). Treatment-related adverse events occurred in 28% of patients with lanreotide (grade 3 in two patients). CONCLUSION Although survival outcomes were not significantly prolonged with lanreotide as a maintenance in SCLC expressing somatostatin receptors after response to standard treatment, lanreotide showed a slight PFS benefit in LD SCLC deserving further investigations.",2019,"Stage was an independent predictor for PFS (HR 3.14, 95% CI 1.77-5.57; P < 0.0001).","['small-cell lung cancer expressing somatostatine receptors', 'Seventy-one patients']","['maintenance lanreotide 120', 'platinum-based chemotherapy with/without radiotherapy', 'lanreotide', 'somatostatine analogue lanreotide']","['adverse events', 'survival outcomes', 'Median OS', 'Median PFS', 'progression-free survival (PFS', 'overall survival (OS) and safety']","[{'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",71.0,0.230939,"Stage was an independent predictor for PFS (HR 3.14, 95% CI 1.77-5.57; P < 0.0001).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Santo', 'Affiliation': 'Medical Oncology, University of Verona, AOUI Verona, Verona, Italy. Electronic address: antonio.santo@aovr.veneto.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pilotto', 'Affiliation': 'Medical Oncology, University of Verona, AOUI Verona, Verona, Italy. Electronic address: sara.pilotto@univr.it.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Galetta', 'Affiliation': 'IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy. Electronic address: galetta@oncologico.bari.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Grossi', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano Italy. Electronic address: francesco.grossi@policlinico.mi.it.""}, {'ForeName': 'Gianpiero', 'Initials': 'G', 'LastName': 'Fasola', 'Affiliation': 'Azienda Ospedaliera Universitaria Santa Maria della Misericordia, Udine, Italy. Electronic address: gianpiero.fasola@asuiud.sanita.fvg.it.'}, {'ForeName': 'Gianpiero', 'Initials': 'G', 'LastName': 'Romano', 'Affiliation': 'Presidio Ospedaliero Vito Fazzi, Lecce, Italy. Electronic address: giampieroromano@me.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonanno', 'Affiliation': 'Istituto Oncologico Veneto, Padova, Italy. Electronic address: laura.bonanno@iov.veneto.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bearz', 'Affiliation': 'CRO-IRCCS, Aviano, Italy. Electronic address: abearz@cro.it.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Papi', 'Affiliation': 'Ospedale Infermi, Rimini, Italy. Electronic address: maximilian.papi@auslromagna.it.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Roca', 'Affiliation': 'Azienda Ospedaliera Civili di Brescia, Brescia, Italy. Electronic address: elisa.roca@unibs.it.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Catino', 'Affiliation': 'IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy. Electronic address: a.catino@oncologico.bari.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Follador', 'Affiliation': 'Azienda Ospedaliera Universitaria Santa Maria della Misericordia, Udine, Italy. Electronic address: follador.alessandro@aoud.sanita.fvg.it.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rijavec', 'Affiliation': ""IRCCS AOU 'San Martino' IST, Genoa, Italy. Electronic address: erika.rijavec@hsanmartino.it.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Genova', 'Affiliation': ""IRCCS AOU 'San Martino' IST, Genoa, Italy. Electronic address: carlo.genova1985@gmail.com.""}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Petrillo', 'Affiliation': 'IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy. Electronic address: petrillo@oncologico.bari.it.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Favaretto', 'Affiliation': 'Ospedale ""S. Maria di Ca\' Foncello"", Treviso, Italy. Electronic address: adolfo.favaretto@aulss2.veneto.it.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Giannone', 'Affiliation': 'Medical Oncology, University of Verona, AOUI Verona, Verona, Italy. Electronic address: luciana.giannone@aovr.veneto.it.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Milella', 'Affiliation': 'Medical Oncology, University of Verona, AOUI Verona, Verona, Italy. Electronic address: michele.milella@univr.it.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica Del Sacro Cuore, Rome, Italy. Electronic address: giampaolo.tortora@unicatt.it.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Giannarelli', 'Affiliation': 'Biostatistics, IRCCS - Regina Elena National Cancer Institute, Rome, Italy. Electronic address: diana.giannarelli@ifo.gov.it.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Bria', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica Del Sacro Cuore, Rome, Italy. Electronic address: emilio.bria@unicatt.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.06.011'] 559,31269801,"Effectiveness of an HIV-risk reduction intervention to reduce HIV transmission among serodiscordant couples in Durban, South Africa. A randomized controlled trial.","Lack of condom use by married or cohabiting couples in populations with high rates of HIV infection has become a significant public health issue. This study investigated whether an HIV risk-reduction intervention (RRI) would increase condom use when delivered to serodiscordant couples as a unit. Of the 62 couples that were screened, 30 serodiscordant couples were enrolled in the study, and randomized 2:1 to an immediate intervention-waitlist control study. The 12-week intervention focused on communication, problem-solving, and negotiation skills. Participants were assessed at baseline, three and six months after the intervention. The main outcome measures were consistent condom use, HIV seroconversion and fidelity to the programme. The use of condoms increased for both the intervention and control groups after receiving a 12-week RRI. Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts ( p  = 0.0119) between the control and intervention groups, the later showing an increase in condom use. No seroconversion was detected, and the overall retention rate of participants was 83.33%. Counselling heterosexual couples as a unit prompted an increase in condom use, but sustained condom use remains a challenge.",2020,"Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts ( p  = 0.0119) between the control and intervention groups, the later showing an increase in condom use.","['62 couples that were screened, 30 serodiscordant couples', 'serodiscordant couples in Durban, South Africa', 'Counselling heterosexual couples']","['HIV-risk reduction intervention', 'communication, problem-solving, and negotiation skills', 'HIV risk-reduction intervention (RRI', 'immediate intervention-waitlist control study']","['overall retention rate', 'mean proportion of condom-protected sex acts', 'HIV transmission', 'condom use, HIV seroconversion and fidelity to the programme']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]",30.0,0.0682837,"Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts ( p  = 0.0119) between the control and intervention groups, the later showing an increase in condom use.","[{'ForeName': 'Sibongile', 'Initials': 'S', 'LastName': 'Mashaphu', 'Affiliation': 'School of Clinical Medicine, University of KwaZulu-Natal, College of Health Sciences, Durban, South Africa.'}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Wyatt', 'Affiliation': 'Department of Psychiatry and Bio-Behavioural, Sciences University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Muyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Bio-Behavioural, Sciences University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Thuli', 'Initials': 'T', 'LastName': 'Mthiyane', 'Affiliation': 'South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Honghu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry and Bio-Behavioural, Sciences University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Exnevia', 'Initials': 'E', 'LastName': 'Gomo', 'Affiliation': 'School of Nursing and Public Health, University of KwaZulu-Natal, College of Health Sciences, Durban, South Africa.'}]",AIDS care,['10.1080/09540121.2019.1634785'] 560,32093664,A quasi-experiment assessing the six-months effects of a nurse care coordination program on patient care experiences and clinician teamwork in community health centers.,"BACKGROUND Recognition that coordination among healthcare providers is associated with better quality of care and lower costs has increased interest in interventions designed to improve care coordination. One intervention is to add care coordination to nurses' role in a formal way. Little is known about effects of this approach, which tends to be pursued by small organizations and those in lower-resource settings. We assessed effects of this approach on care experiences of high-risk patients (those most in need of care coordination) and clinician teamwork during the first 6 months of use. METHODS We conducted a quasi-experimental study using a clustered, controlled pre-post design. Changes in staff and patient experiences at six community health center practice locations that introduced the added-role approach for high-risk patients were compared to changes in six locations without the program in the same health system. In the pre-period (6 months before intervention training) and post-period (about 6 months after intervention launch, following 3 months of training), we surveyed clinical staff (N = 171) and program-qualifying patients (3007 pre-period; 2101 post-period, including 113 who were enrolled during the program's first 6 months). Difference-in-differences models examined study outcomes: patient reports about care experiences and clinician-reported teamwork. We assessed frequency of patient office visits to validate access and implementation, and contextual factors (training, resources, and compatibility with other work) that might explain results. RESULTS Patient care experiences across all high-risk patients did not improve significantly (p > 0.05). They improved somewhat for program enrollees, 5% above baseline reports (p = 0.07). Staff-perceived teamwork did not change significantly (p = 0.12). Office visits increased significantly for enrolled patients (p < 0.001), affirming program implementation (greater accessing of care). Contextual factors were not reported as problematic, except that 41% of nurses reported incompatibility between care coordination and other job demands. Over 75% of nurses reported adequate training and resources. CONCLUSIONS There were some positive effects of adding care coordination to nurses' role within 6 months of implementation, suggesting value in this improvement strategy. Addressing compatibility between coordination and other job demands is important when implementing this approach to coordination.",2020,"Office visits increased significantly for enrolled patients (p < 0.001), affirming program implementation (greater accessing of care).",['patient care experiences and clinician teamwork in community health centers'],['nurse care coordination program'],['Office visits'],"[{'cui': 'C0017313'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0028900', 'cui_str': 'Office Visits'}]",,0.018514,"Office visits increased significantly for enrolled patients (p < 0.001), affirming program implementation (greater accessing of care).","[{'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Nembhard', 'Affiliation': 'The Wharton School, University of Pennsylvania, Health Care Management Department, 3641 Locust Walk, 207 Colonial Penn Center, Philadelphia, PA, 19104, USA. ingridn@wharton.upenn.edu.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Yale Center for Analytical Sciences (YCAS), 300 George Street, Suite 555, New Haven, CT, 06519, USA.'}, {'ForeName': 'Yuna S H', 'Initials': 'YSH', 'LastName': 'Lee', 'Affiliation': 'Columbia University Mailman School of Public Health, Department of Health Policy & Management, 722 West 168th Street, R476, New York, NY, 10032, USA.'}, {'ForeName': 'Daren', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'Weitzman Institute, Community Health Center, Inc., 631 Main St., Middletown, CT, 06457, USA.'}, {'ForeName': 'Ianita', 'Initials': 'I', 'LastName': 'Zlateva', 'Affiliation': 'Weitzman Institute, Community Health Center, Inc., 631 Main St., Middletown, CT, 06457, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Cleary', 'Affiliation': 'Yale School of Public Health, 60 College St., P.O. Box 208034, New Haven, CT, 06520-8034, USA.'}]",BMC health services research,['10.1186/s12913-020-4986-0'] 561,32209721,"Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials.","BACKGROUND The interleukin-12/23p40-subunit-inhibitor ustekinumab significantly improved spondylitis-related symptoms through Week 24 in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (PA-PRS) in PSUMMIT-1&2. We further evaluated ustekinumab's effect on spondylitis-related endpoints in PSUMMIT-1&2 tumour necrosis factor-inhibitor (TNFi)-naïve patients with PA-PRS. METHODS Patients with active PsA (≥5 swollen and ≥5 tender joints, C-reactive-protein ≥ 3.0 mg/L) despite conventional (PSUMMIT-1&2) and/or prior TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45 mg, 90 mg or placebo (Week 0, Week 4, Week 16). Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck/back/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses were assessed at Weeks 12 and 24. RESULTS The pooled PSUMMIT-1&2, TNFi-naïve (n=747), PA-PRS (n=223) subset (158 with human-leucocyte-antigen ( HLA)-B27 results) presented with moderate-to-severe spondylitis-related symptoms (mean BASDAI-neck/back/hip pain-6.51, mBASDAI-6.54, BASDAI-6.51, ASDAS-3.81). Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (-1.99 vs -0.18) and mBASDAI (-2.09 vs -0.59). Improvements in neck/back/hip pain and fatigue appeared numerically greater in HLA-B27 + than HLA-B27 - patients; those for other domains were generally consistent. Greater proportions of ustekinumab versus placebo-treated patients achieved ASDAS clinically important improvement at Week 24 (decrease ≥ 1.1; 49.6% vs 12.7%; nominal p<0.05). CONCLUSIONS Improvements in BASDAI neck/back/hip pain and mBASDAI among ustekinumab-treated, TNFi-naïve, PsA patients with PA-PRS were clinically meaningful and consistent across assessment tools. Numerically greater improvements in neck/back/hip pain in HLA-B27 + than HLA-B27 - patients, noted in the context of similar overall mBASDAI improvements between the subgroups, suggest ustekinumab may improve disease activity in TNFi-naïve PsA patients likely to exhibit axial disease. CLINICAL TRIAL REGISTRATION NUMBERS PSUMMIT 1, NCT01009086; PSUMMIT 2, NCT01077362.",2020,Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (-1.99 vs -0.18) and mBASDAI (-2.09 vs -0.59).,"['Patients with active PsA (≥5 swollen and ≥5 tender joints, C-reactive-protein ≥ 3.0\u2009mg/L) despite conventional (PSUMMIT-1&2) and/or prior', 'tumour necrosis factor-inhibitor (TNFi)-naïve patients with PA-PRS', 'TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis']","['ustekinumab', 'interleukin-12/23p40-subunit-inhibitor ustekinumab', 'placebo', 'TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45\u2009mg, 90\u2009mg or placebo']","['Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck/back/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses', 'neck/back/hip pain and fatigue', 'neck/back/hip pain', 'hip pain', 'disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0150141'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0989843,Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (-1.99 vs -0.18) and mBASDAI (-2.09 vs -0.59).,"[{'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Section of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK p.helliwell@leeds.ac.uk.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Krembil Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Chetan S', 'Initials': 'CS', 'LastName': 'Karyekar', 'Affiliation': 'Janssen Global Services LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Janssen Research & Development LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'Janssen Research & Development LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Sweet', 'Affiliation': 'Janssen Research & Development LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University of California San Francisco School of Medicine, San Francisco, California, USA.'}]",RMD open,['10.1136/rmdopen-2019-001149'] 562,32103160,Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.,"OBJECTIVE To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance. STUDY DESIGN Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R). RESULTS Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress. CONCLUSION A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.",2020,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","['preterm neonates that met study criteria (n\u2009=\u2009169', 'premature neonates', 'preterm neonates', 'preterm neonates experiencing a clinically required heel lance']","['Oral dextrose', 'oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2\u2009min before heel lance', '30% oral dextrose']","['premature infant pain profile-revised (PIPP-R', 'plasma markers of ATP utilization and oxidative stress', 'biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress', 'Pain', 'procedural pain', 'Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C3179031', 'cui_str': 'Facilitated Tucking'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}]",169.0,0.263784,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","[{'ForeName': 'Danilyn M', 'Initials': 'DM', 'LastName': 'Angeles', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA. dangeles@llu.edu.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Boskovic', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'School of Public Health, Loma Linda Univeristy, Loma Linda, CA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hoch', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Forde', 'Affiliation': 'School of Nursing, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Raylene M', 'Initials': 'RM', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hopper', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Deming', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Giang', 'Initials': 'G', 'LastName': 'Truong', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Aprille', 'Initials': 'A', 'LastName': 'Febre', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pegis', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Lavery', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Munaf', 'Initials': 'M', 'LastName': 'Kadri', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Mousselli', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Vora', 'Initials': 'V', 'LastName': 'Farha', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Elba', 'Initials': 'E', 'LastName': 'Fayard', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0634-0'] 563,32192678,TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial.,"OBJECTIVES This study was a sham-controlled, double-blind, randomized clinical trial to examine the effect of chronic low level tragus stimulation (LLTS) in patients with paroxysmal AF. BACKGROUND Low-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus (LLTS) acutely suppresses atrial fibrillation (AF) in humans, but the chronic effect remains unknown. METHODS LLTS (20 Hz, 1 mA below the discomfort threshold) was delivered using an ear clip attached to the tragus (active arm) (n = 26) or the ear lobe (sham control arm) (n = 27) for 1 h daily over 6 months. AF burden over 2-week periods was assessed by noninvasive continuous electrocardiogram monitoring at baseline, 3 months, and 6 months. Five-minute electrocardiography and serum were obtained at each visit to measure heart rate variability and inflammatory cytokines, respectively. RESULTS Baseline characteristics were balanced between the 2 groups. Adherence to the stimulation protocol (≤4 sessions lost per month) was 75% in the active arm and 83% in the control arm (p > 0.05). At 6 months, the median AF burden was 85% lower in the active arm compared with the control arm (ratio of medians: 0.15; 95% confidence interval: 0.03 to 0.65; p = 0.011). Tumor necrosis factor-alpha was significantly decreased by 23% in the active group relative to the control group (ratio of medians: 0.77; 95% confidence interval: 0.63 to 0.94; p = 0.0093). Frequency domain indices of heart rate variability were significantly altered with active versus control stimulation (p < 0.01). No device-related side effects were observed. CONCLUSIONS Chronic, intermittent LLTS resulted in lower AF burden than did sham control stimulation, supporting its use to treat paroxysmal AF in selected patients. (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation [TREAT-AF]; NCT02548754).",2020,Frequency domain indices of heart rate variability were significantly altered with active versus control stimulation (p < 0.01).,"['LLTS', 'patients with paroxysmal AF', 'Suppress Atrial Fibrillation']","['chronic low level tragus stimulation (LLTS', 'Transcutaneous Electrical Vagus Nerve Stimulation', 'TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to']","['Tumor necrosis factor-alpha', 'heart rate variability', 'median AF burden']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229312', 'cui_str': 'Tragus structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.436147,Frequency domain indices of heart rate variability were significantly altered with active versus control stimulation (p < 0.01).,"[{'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Stavrakis', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. Electronic address: stavros-stavrakis@ouhsc.edu.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Stoner', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Humphrey', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lynsie', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Filiberti', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Reynolds', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elkholey', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Isma', 'Initials': 'I', 'LastName': 'Javed', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Twidale', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Riha', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Subha', 'Initials': 'S', 'LastName': 'Varahan', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Scherlag', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Warren M', 'Initials': 'WM', 'LastName': 'Jackman', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Tarun W', 'Initials': 'TW', 'LastName': 'Dasari', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Po', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.11.008'] 564,31753727,"Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial.","BACKGROUND Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. METHODS We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m 2 (60 mg/m 2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. FINDINGS Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3-4·8] vs 2·8 months [2·6-2·9]; HR 0·696 [95% CI 0·573-0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9-11·4) in the ramucirumab group versus 7·9 months (7·0-9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724-1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group. INTERPRETATION Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. FUNDING Eli Lilly and Company.",2020,Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group).,"['patients with platinum-refractory advanced urothelial carcinoma', 'patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE', '0·887', 'patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy', 'Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries', 'Between July 20, 2015, and April 4, 2017, 530 patients']","['docetaxel', 'ramucirumab plus docetaxel', 'Ramucirumab plus docetaxel', 'placebo', 'interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m 2 (60 mg/m 2 in Korea, Taiwan, and Japan', 'placebo plus docetaxel']","['leading to death', 'Progression-free survival', 'progression-free survival', 'progression-free survival at the overall survival database lock, median progression-free survival', 'overall survival', 'febrile neutropenia', 'neutropenia', 'Median overall survival', 'Serious adverse events', 'Grade 3 or worse treatment-related treatment-emergent adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",530.0,0.755003,Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group).,"[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, Yale University, New Haven, CT, USA. Electronic address: daniel.petrylak@yale.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'San Camillo and Forlanini Hospitals, Rome, Italy.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital Universitario 12 de Octubre (CiberOnc), Madrid, Spain.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P.A. Herzen Moscow Oncological Research Institute, Moscow, Russia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Géczi', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Yen-Chuan', 'Initials': 'YC', 'LastName': 'Ou', 'Affiliation': ""Tungs' Taichung Metro Harbor Hospital, Taichung, Taiwan.""}, {'ForeName': 'Hasan Senol', 'Initials': 'HS', 'LastName': 'Coskun', 'Affiliation': 'Akdeniz University School of Medicine, Antalya, Turkey.'}, {'ForeName': 'Wen-Pin', 'Initials': 'WP', 'LastName': 'Su', 'Affiliation': 'Institute of Clinical Medicine, College of Medicine, National Cheng Kung University & Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'Department of Urology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gakis', 'Affiliation': 'Department of Urology, University of Tübingen, Tübingen, Germany; Pediatric Urology, Julius Maximillians University, Würzburg, Germany.'}, {'ForeName': 'Ivor J', 'Initials': 'IJ', 'LastName': 'Percent', 'Affiliation': 'Florida Cancer Specialists, Port Charlotte, FL, USA.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Turin, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Semenov', 'Affiliation': 'RBHI Ivanovo Regional Oncology Dispensary, Ivanovo, Russia.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Laestadius', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Peer', 'Affiliation': 'Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'University of Verona and Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Sufia', 'Initials': 'S', 'LastName': 'Safina', 'Affiliation': 'Tatarstan Regional Cancer Center, Kazan, Russia.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia Del Muro', 'Affiliation': ""Institut Català d'Oncologia L'Hospitalet, Institut d'Investigacio Biomedica de Bellvitge, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Alejo', 'Initials': 'A', 'LastName': 'Rodriguez-Vida', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University, Edirne, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Harputluoglu', 'Affiliation': 'Inonu University, Malatya, Turkey.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Tagawa', 'Affiliation': 'New York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Ulka', 'Initials': 'U', 'LastName': 'Vaishampayan', 'Affiliation': 'Karmanos Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Jeanny B', 'Initials': 'JB', 'LastName': 'Aragon-Ching', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, VA, USA.'}, {'ForeName': 'Oday', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Astra M', 'Initials': 'AM', 'LastName': 'Liepa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Russo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Walgren', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Annamaria H', 'Initials': 'AH', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Hozak', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bell-McGuinn', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30668-0'] 565,32217018,Analysis of the Socio-Personal Profile of Latin Americans Living in Spain and the United States: Does It Justify the Differences in Attitude Toward Organ Donation?,"INTRODUCTION There are differences in the attitude toward organ donation between Latin Americans living in Spain and those living in the United States. OBJECTIVE We sought to analyze the socio-personal factors that can condition the difference in attitude toward donation between Latin Americans living in the United States and those living in Spain. MATERIALS AND METHODS Participants in the study were Latin Americans living in Spain (group A; n=1237) and the United States (Florida) (group B; n=1450), extracted from the database of the International Collaborative Donor Project (PCID). Inclusion criteria were a sample population stratified by area, country of birth, age, and sex. The instrument used was a validated attitude questionnaire toward living kidney donation (PCID-DTO-Rios.) Participants were randomly selected to be surveyed according to stratification. RESULTS The attitude in favor of Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B) (P < .001). The socio-personal profile of the Latin Americans in Spain compared with those in the United States indicates that they are mainly women (63.5% vs 43.7%, respectively), younger (31.78 vs 37.31 years, respectively), have more secondary education (21.2% vs 16.3%, respectively) and university studies (11% vs 6%, respectively), are of South American origin vs those who are Mexican and Central American, respectively, and there is a higher percentage of atheists/agnostics (8.1% vs 3.7%). However, the personal profile toward donation is similar in both groups, both for and against organ donation. CONCLUSIONS The personal social profile of the Latin American resident in Spain is different from that of the resident in the United States. However, the psycho-social profile for and against organ donation is similar in both countries.",2020,The attitude in favor of Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B),"['Latin Americans living in the United States and those living in Spain', 'Latin Americans Living in Spain and the United States', 'Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B', 'Participants in the study were Latin Americans living in Spain (group A; n=1237) and the United States (Florida) (group B; n=1450), extracted from the database of the International Collaborative Donor Project (PCID', 'Inclusion criteria were a sample population stratified by area, country of birth, age, and sex']",[],"['attitude questionnaire toward living kidney donation (PCID-DTO-Rios', 'secondary education']","[{'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1277523', 'cui_str': 'Country of birth - Australasian (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0369331,The attitude in favor of Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B),"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ríos', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain. Electronic address: arzrios@um.es.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Carrillo', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'López-Navas', 'Affiliation': 'Department of Psychology, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Flores-Medina', 'Affiliation': 'Department of Psychology, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Ayala-García', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; School of Medicine of the University of Quetzalcoatl in Irapuato, Guanajuato, Mexico.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Martinez-Insfran', 'Affiliation': 'Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Parrilla', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ramírez', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.02.065'] 566,32217111,Argon plasma coagulation alone versus argon plasma coagulation plus full-thickness endoscopic suturing to treat weight regain after Roux-en-Y gastric bypass: a prospective randomized trial (with videos).,"BACKGROUND AND AIMS A significant number of patients regain weight after Roux-en-Y gastric bypass. Ablation with argon plasma coagulation (APC) plus endoscopic full-thickness suturing (FTS-APC) and ablation alone have been reported for treating weight regain when associated with gastrojejunostomy (GJ) dilation. However, comparative controlled data are still lacking. METHODS This was a pilot single-center open-label randomized trial comparing the effectiveness and safety of APC alone versus FTS-APC for transoral outlet reduction. Patients with at least 20% weight regain from the nadir, and GJ ≥15 mm were considered eligible. The primary outcome was percentage total weight loss (%TWL) at 12 months. Secondary outcomes were the incidence of adverse events, amelioration of metabolic laboratory parameters, and improvement in quality of life and eating behavior. RESULTS Forty patients meeting the eligibility criteria were enrolled from October 2017 to July 2018. Technical and clinical success rates were similar between the groups. At 12 months, the mean %TWL was 8.3% ± 5.5% in the APC alone group versus 7.5% ± 7.7% in the FTS-APC group (P = .71). The pre-revisional % solid gastric retention at 1 hour positively correlated with the probability of achieving ≥10% TWL at 12 months. Both groups experienced significant reductions in low-density lipoprotein and triglyceride levels at 12 months, and improvement in eating behavior and quality of life at 3 months. There were 2 cases of stenoses (1 from each group), which were successfully treated with endoscopic balloon dilation. CONCLUSION APC alone is similar to FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up. (Clinical trial registration number: NCT03094936.).",2020,The APC alone is similar to the FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up.,"['patients regain weight after Roux-en-Y gastric bypass (RYGB', 'Forty patients meeting eligibility criteria were enrolled from October 2017 to July 2018', 'after Roux-en-Y gastric bypass', 'Patients with at least 20% weight regain from the nadir, and GJ ≥15 mm were considered eligible']","['argon plasma coagulation (APC) plus endoscopic full-thickness suturing (FTS-APC) and ablation alone', 'endoscopic balloon dilation', 'APC alone versus FTS-APC', 'FTS-APC', 'Argon plasma coagulation alone versus endoscopic suturing plus argon plasma coagulation']","['weight regain', 'total weight loss', 'eating behavior and QOL', 'incidence of adverse events, amelioration of metabolic laboratory parameters, and improvement in quality of life (QOL) and eating behavior', 'LDL and triglycerides levels', 'Technical and clinical success rates', 'prerevisional % solid gastric retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439809', 'cui_str': 'Full thickness (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0585136', 'cui_str': 'Gastric retention (disorder)'}]",40.0,0.0755459,The APC alone is similar to the FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up.,"[{'ForeName': 'Vitor Ottoboni', 'Initials': 'VO', 'LastName': 'Brunaldi', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil; Center for Gastrointestinal Endoscopy, Surgery and Anatomy Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Galileu Ferreira Ayala', 'Initials': 'GFA', 'LastName': 'Farias', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Daniel Tavares', 'Initials': 'DT', 'LastName': 'de Rezende', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cairo-Nunes', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Riccioppo', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Diogo Turiani Hourneaux', 'Initials': 'DTH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Marco Aurelio', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.03.3757'] 567,32216964,Intention to control low central venous pressure reduced blood loss during laparoscopic hepatectomy: A double-blind randomized clinical trial.,"BACKGROUND Excessive intraoperative hemorrhage is a critical factor of poor prognoses after hepatectomy. Low central venous pressure during parenchymal transection is recognized to effectively reduce intraoperative hemorrhage in open procedures. However, the role of controlled low central venous pressure in laparoscopic hepatectomy is still controversial. METHODS In the present randomized clinical trial, we set up a standard boundary of low central venous pressure according to our Pilot Study, then enrolled patients scheduled for elective laparoscopic hepatectomy and allocated them randomly to a group undergoing central venous pressure reduction by anesthesiologic interventions or a control group. The primary efficacy endpoint was total intraoperative blood loss and perioperative adverse events. Analyses were performed following the intention-to-treat principle, and patients and surgeons were blinded (ClinicalTrials.gov, Number: NCT03422913). RESULTS Between January 2017 and October 2018, 146 out of 469 patients were randomized and eligible for inclusion in the final analyses. Based on the retrospective training cohort, we set a central venous pressure of 5 cm H 2 O as a cutoff value (standard low central venous pressure). Compared with patients in the control group, those in the controlled low central venous pressure group had a significantly lower central venous pressure during resection (4.83 ± 3.41 cm H 2 O vs 9.26 ± 3.38 cm H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001). The perioperative adverse events were comparable in both study groups (P = .313). CONCLUSION The safety and efficacy of controlled low central venous pressure were demonstrated in complex laparoscopic hepatectomy for the first time by our study, and this technique is recommended to be applied routinely in laparoscopic hepatectomy.",2020,H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001).,"['Between January 2017 and October 2018, 146 out of 469 patients were randomized and eligible for inclusion in the final analyses']","['laparoscopic hepatectomy', 'elective laparoscopic hepatectomy and allocated them randomly to a group undergoing central venous pressure reduction by anesthesiologic interventions or a control group', 'control low central venous pressure']","['total intraoperative blood loss and perioperative adverse events', 'perioperative adverse events', 'intraoperative hemorrhage', 'central venous pressure', 'blood loss', 'total intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}]",469.0,0.0917269,H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001).,"[{'ForeName': 'Yang-Xun', 'Initials': 'YX', 'LastName': 'Pan', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jun-Cheng', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Anesthesiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jin-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jian-Cong', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Yi-Zhen', 'Initials': 'YZ', 'LastName': 'Fu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Yao-Jun', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Min-Shan', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Ren-Chun', 'Initials': 'RC', 'LastName': 'Lai', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Anesthesiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China. Electronic address: lairch@sysucc.org.cn.'}, {'ForeName': 'Zhong-Guo', 'Initials': 'ZG', 'LastName': 'Zhou', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China. Electronic address: zhouzhg@sysucc.org.cn.'}]",Surgery,['10.1016/j.surg.2020.02.004'] 568,31618129,Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer.,"PURPOSE We evaluated the addition of bevacizumab, a humanized monoclonal antibody that targets vascular endothelial growth factor, to platinum-based chemotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). PATIENTS AND METHODS Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier) recurrent or metastatic SCCHN were randomly assigned to receive a platinum-based chemotherapy doublet with or without bevacizumab 15 mg/kg given intravenously every 3 weeks until disease progression. Chemotherapy could be discontinued after six cycles if a maximum response was achieved. RESULTS The study randomly assigned 403 patients. Median overall survival (OS) was 12.6 months with bevacizumab plus chemotherapy (BC) and 11.0 months with chemotherapy alone (hazard ratio, 0.87; 95% CI, 0.70 to 1.09; P = .22). At 2, 3, and 4 years, the OS rates were 25.2% v 18.1%, 16.4% v 10.0%, and 11.8% v 6.4% for BC versus chemotherapy, respectively. In an analysis of 365 eligible patients who started treatment, the hazard ratio was 0.82 (95% CI, 0.65 to 1.04; P = .10), with a median OS of 14.2 months on BC v 11.1 months on chemotherapy. Median progression-free survival with BC was 6.0 months v 4.3 months with chemotherapy ( P = .0014). Overall response rates were 35.5% with BC and 24.5% with chemotherapy ( P = .016). There was increased toxicity, including a higher rate of treatment-related grade 3 to 5 bleeding events (6.7% v 0.5%; P < .001) and treatment-related deaths (9.3% v 3.5%; P = .022) with BC versus chemotherapy. CONCLUSION The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities. These results encourage biomarker-driven studies of angiogenesis inhibitors with better toxicity profiles in select patients with SCCHN.",2019,The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities.,"['403 patients', 'Patients With Recurrent or Metastatic Head and Neck Cancer', 'select patients with SCCHN', 'recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN', 'Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier', 'recurrent or metastatic SCCHN']","['platinum-based chemotherapy', 'platinum-based chemotherapy doublet with or without bevacizumab', 'bevacizumab plus chemotherapy (BC', 'bevacizumab', 'Chemotherapy With or Without Bevacizumab', 'Chemotherapy']","['treatment-related deaths', 'response rate and progression-free survival with increased toxicities', 'higher rate of treatment-related grade 3 to 5 bleeding events', 'toxicity', 'Overall response rates', 'Median overall survival (OS', 'OS rates', 'hazard ratio', 'Median progression-free survival with BC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",403.0,0.094703,The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities.,"[{'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Argiris', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Panayiotis', 'Initials': 'P', 'LastName': 'Savvides', 'Affiliation': 'University of Arizona Cancer Center, Phoenix, AZ.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Ohr', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Marshall A', 'Initials': 'MA', 'LastName': 'Levine', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, MD.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Chakravarti', 'Affiliation': 'The Ohio State University Medical School, Columbus, OH.'}, {'ForeName': 'Missak', 'Initials': 'M', 'LastName': 'Haigentz', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Chukwuemeka V', 'Initials': 'CV', 'LastName': 'Ikpeazu', 'Affiliation': 'University of Miami, Miami, FL.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Schneider', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Harlan A', 'Initials': 'HA', 'LastName': 'Pinto', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Forastiere', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00555'] 569,31667490,Depression and Incident HIV in Adolescent Girls and Young Women in HIV Prevention Trials Network 068: Targets for Prevention and Mediating Factors.,"The human immunodeficiency virus (HIV) epidemic among adolescent girls and young women (AGYW) in sub-Saharan Africa is a critical public health problem. We assessed whether depressive symptoms in AGYW were longitudinally associated with incident HIV, and identified potential social and behavioral mediators. Data came from a randomized trial of a cash transfer conditional on school attendance among AGYW (ages 13-21 years) in rural Mpumalanga Province, South Africa, during 2011-2017. We estimated the relationship between depressive symptoms and cumulative HIV incidence using a linear probability model, and we assessed mediation using inverse odds ratio weighting. Inference was calculated using the nonparametric bootstrap. AGYW with depressive symptoms had higher cumulative incidence of HIV compared with those without (risk difference = 3.5, 95% confidence interval (CI): 0.1, 7.0). The strongest individual mediators of this association were parental monitoring and involvement (indirect effect = 1.6, 95% CI: 0.0, 3.3) and reporting a partner would hit her if she asked him to wear a condom (indirect effect = 1.5, 95% CI: -0.3, 3.3). All mediators jointly explained two-thirds (indirect effect = 2.4, 95% CI: 0.2, 4.5) of the association between depressive symptoms and HIV incidence. Interventions addressing mental health might reduce risk of acquiring HIV among AGYW.",2020,"AGYW with depressive symptoms had higher cumulative incidence of HIV compared to those without (risk difference = 3.5 [95% CI 0.1, 7.0]).","['adolescent girls and young women', 'adolescent girls and young women in HPTN 068', 'on school attendance among AGYW (ages 13 - 21) in rural Mpumalanga Province, South Africa during 2011-2017']",['cash transfer conditional'],"['Depression and incident HIV', 'depressive symptoms', 'cumulative incidence of HIV', 'depressive symptoms and HIV incidence', 'depressive symptoms and cumulative HIV incidence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.25429,"AGYW with depressive symptoms had higher cumulative incidence of HIV compared to those without (risk difference = 3.5 [95% CI 0.1, 7.0]).","[{'ForeName': 'Dana E', 'Initials': 'DE', 'LastName': 'Goin', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Pearson', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, United Kingdom.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sheri A', 'Initials': 'SA', 'LastName': 'Lippman', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Hamilton', 'Affiliation': 'HIV Prevention Trials Network Leadership and Operations Center, Science Facilitation Department, FHI 360, Durham, North Carolina.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Selin', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'MacPhail', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Wagner', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Gomez-Olive', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Twine', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, Washington.'}, {'ForeName': 'Yaw', 'Initials': 'Y', 'LastName': 'Agyei', 'Affiliation': 'Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tollman', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ahern', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, California.'}]",American journal of epidemiology,['10.1093/aje/kwz238'] 570,32217654,The natural history of progressive fibrosing interstitial lung diseases.,"We used data from the INBUILD and INPULSIS trials to investigate the natural history of progressive fibrosing interstitial lung diseases (ILDs).Subjects in the two INPULSIS trials had a clinical diagnosis of idiopathic pulmonary fibrosis (IPF) while subjects in the INBUILD trial had a progressive fibrosing ILD other than IPF and met protocol-defined criteria for ILD progression despite management. Using data from the placebo groups, we compared the rate of decline in forced vital capacity (FVC) (mL·year -1 ) and mortality over 52 weeks in the INBUILD trial with pooled data from the INPULSIS trials.The adjusted mean annual rate of decline in FVC in the INBUILD trial (n=331) was similar to that observed in the INPULSIS trials (n=423) (-192.9 mL·year -1 and -221.0 mL·year -1 , respectively; nominal p-value=0.19). The proportion of subjects who had a relative decline in FVC >10% predicted at Week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials. A relative decline in FVC >10% predicted was associated with an increased risk of death in the INBUILD trial (hazard ratio 3.64) and the INPULSIS trials (hazard ratio 3.95).These findings indicate that patients with fibrosing ILDs other than IPF, who are progressing despite management, have a subsequent clinical course similar to patients with untreated IPF, with a high risk of further ILD progression and early mortality.",2020,"The proportion of subjects who had a relative decline in FVC >10% predicted at week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials.",[],['placebo'],"['rate of decline in forced vital capacity (FVC) (mL·year -1 ) and mortality', 'risk of death']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.169527,"The proportion of subjects who had a relative decline in FVC >10% predicted at week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials.","[{'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Dept of Medicine, National Jewish Health, Denver, CO, USA brownk@njhealth.org.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Dept of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Simon L F', 'Initials': 'SLF', 'LastName': 'Walsh', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Thannickal', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Prasse', 'Affiliation': 'Dept of Respiratory Medicine, MHH Hannover Medical School and Biomedical Research in Endstage and Obstructive Lung Disease (BREATH), Deutsches Zentrum für Lungenforschung (DZL), Hannover, Germany.'}, {'ForeName': 'Rozsa', 'Initials': 'R', 'LastName': 'Schlenker-Herceg', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Rainer-Georg', 'Initials': 'RG', 'LastName': 'Goeldner', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Clerisme-Beaty', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tetzlaff', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Centre for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, UMR 754, Claude Bernard University Lyon 1, Lyon, France.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}]",The European respiratory journal,['10.1183/13993003.00085-2020'] 571,32215674,"Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial.","OBJECTIVE This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis. METHODS The study included 104 patients (mean age 61.0 ± 6.2 years; range 50 to 70 years) who were admitted to our outpatient clinic with newly diagnosed with knee osteoarthritis. Patients were randomly assigned to two groups. Both groups received transcutaneous electrical nerve stimulation for 30 minutes, hot pack for 40 minutes, and home-based exercise program of around the knee strengthening for 30 minutes in a day for three weeks (5 days in a week). Also, one group was treated with r-ESWT, while the other group was treated with sham-ESWT. For r-ESWT, patients received 2000 pulses of shockwave at 2.0 to 3.0 bar weekly for three weeks. All patients were evaluated with visual analog scale (VAS), active knee range of motion (ROM), 20-metre walk test, Western Ontario and McMaster Osteoarthritis Index (WOMAC), Lequesne's disability index, and isokinetic muscle performance before treatment, at the end of treatment, at one month and three months after treatment. RESULTS When groups were compared, group 1 scores were significantly better than the group 2 in all outcome parameters except WOMAC-stiffness at the end of treatment, at one month and three month follow-up (all p < 0.05). The VAS-resting, VAS-movement, knee ROM, 20-m walk test, WOMAC, and Lequesne's disability scores and peak torque values of knee extension improved in both groups with the highest improvement in the r-ESWT group. A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months. CONCLUSION Our findings revealed that r-ESWT combined with conventional electrotherapy is an effective treatment for improving pain and physical function in knee osteoarthritis to control symptoms up to three months. CLINICAL TRIALS ID NCT04243135.",2020,"A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months. ","['knee osteoarthritis', 'patients with knee osteoarthritis', '104 patients (mean age 61.0\u2009±\u20096.2\xa0years; range 50 to 70\xa0years) who were admitted to our outpatient clinic with newly diagnosed with knee osteoarthritis']","['radial extracorporeal shock wave therapy', 'sham-ESWT', 'transcutaneous electrical nerve stimulation for 30\xa0minutes, hot pack for 40\xa0minutes, and home-based exercise program of around the knee strengthening', 'r-ESWT treatment with sham-ESWT', 'conventional electrotherapy']","['clinical variables and isokinetic performance', 'pain, walking speed, physical function, and isokinetic muscle strength', ""visual analog scale (VAS), active knee range of motion (ROM), 20-metre walk test, Western Ontario and McMaster Osteoarthritis Index (WOMAC), Lequesne's disability index, and isokinetic muscle performance"", ""VAS-resting, VAS-movement, knee ROM, 20-m walk test, WOMAC, and Lequesne's disability scores and peak torque values of knee extension"", 'pain and physical function', 'WOMAC-stiffness']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",104.0,0.0386954,"A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months. ","[{'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Uysal', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}, {'ForeName': 'Mustafa Turgut', 'Initials': 'MT', 'LastName': 'Yildizgoren', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey. ftr.mustafaturgut@hotmail.com.'}, {'ForeName': 'Hayal', 'Initials': 'H', 'LastName': 'Guler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}, {'ForeName': 'Ayse Dicle', 'Initials': 'AD', 'LastName': 'Turhanoglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04541-w'] 572,31067237,Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial.,"BACKGROUND Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. METHODS AND FINDINGS In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. CONCLUSIONS An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. TRIAL REGISTRATION Clinicaltrials.gov, NCT02319525.",2019,"An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. ","['diverse women with lupus nephritis (IDEA-WON', 'women with lupus nephritis', 'individuals with lupus', 'Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less', 'adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings', 'lupus nephritis', 'Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white']","['individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization', 'immunosuppressive therapy']","['decisional conflict', 'risk factors', 'ease of use of materials', 'understanding lupus nephritis', 'Unresolved decisional conflict', 'medication options', 'sensitivity analysis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0024143', 'cui_str': 'Lupus Glomerulonephritis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0024143', 'cui_str': 'Lupus Glomerulonephritis'}, {'cui': 'C0443342', 'cui_str': 'Unresolved (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",301.0,0.164128,"An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. ","[{'ForeName': 'Jasvinder A', 'Initials': 'JA', 'LastName': 'Singh', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Fraenkel', 'Affiliation': 'Yale University, New Haven, Connecticut, United States of America.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Graciela S', 'Initials': 'GS', 'LastName': 'Alarcón', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Barton', 'Affiliation': 'Oregon Health Science University, Portland, Oregon, United States of America.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Hanrahan', 'Affiliation': 'Lupus Foundation of America, Washington, DC, United States of America.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Raymond', 'Affiliation': 'Lupus Foundation of America, Washington, DC, United States of America.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Kimberly', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Amye L', 'Initials': 'AL', 'LastName': 'Leong', 'Affiliation': 'Healthy Motivation, Inc., Los Angeles, California, United States of America.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Reyes', 'Affiliation': 'Elyse Reyes Consulting, Los Angeles, California, United States of America.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Street', 'Affiliation': 'Texas A&M University, College Station, Texas, United States of America.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Suarez-Almazor', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Guy S', 'Initials': 'GS', 'LastName': 'Eakin', 'Affiliation': 'Arthritis Foundation, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Marrow', 'Affiliation': 'Arthritis Foundation, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Charity J', 'Initials': 'CJ', 'LastName': 'Morgan', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Brennda', 'Initials': 'B', 'LastName': 'Caro', 'Affiliation': 'Georgia State University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sloan', 'Affiliation': 'Mayo Clinic School of Medicine, Rochester, Minnesota, United States of America.'}, {'ForeName': 'Bochra', 'Initials': 'B', 'LastName': 'Jandali', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, United States of America.'}, {'ForeName': 'Salvador R', 'Initials': 'SR', 'LastName': 'Garcia', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Grossman', 'Affiliation': 'University of California, Los Angeles (UCLA), Los Angeles, California, United States of America.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'Oregon Health Science University, Portland, Oregon, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Trupin', 'Affiliation': 'University of California at San Francisco (UCSF), San Francisco, California, United States of America.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""Dall'Era"", 'Affiliation': 'University of California at San Francisco (UCSF), San Francisco, California, United States of America.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Meara', 'Affiliation': 'Ohio State University, Columbus, Ohio, United States of America.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Rizvi', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, United States of America.'}, {'ForeName': 'W Winn', 'Initials': 'WW', 'LastName': 'Chatham', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Jinoos', 'Initials': 'J', 'LastName': 'Yazdany', 'Affiliation': 'University of California at San Francisco (UCSF), San Francisco, California, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1002800'] 573,31329516,"ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer.","PURPOSE Enzalutamide, a potent androgen-receptor inhibitor, has demonstrated significant benefits in metastatic and nonmetastatic castration-resistant prostate cancer. We evaluated the efficacy and safety of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC). METHODS ARCHES (ClinicalTrials.gov identifier: NCT02677896) is a multinational, double-blind, phase III trial, wherein 1,150 men with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg/day) or placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy. The primary end point was radiographic progression-free survival. RESULTS As of October 14, 2018, the risk of radiographic progression or death was significantly reduced with enzalutamide plus ADT versus placebo plus ADT (hazard ratio, 0.39; 95% CI, 0.30 to 0.50; P < .001; median not reached v 19.0 months). Similar significant improvements in radiographic progression-free survival were reported in prespecified subgroups on the basis of disease volume and prior docetaxel therapy. Enzalutamide plus ADT significantly reduced the risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression. More men achieved an undetectable prostate-specific antigen level and/or an objective response with enzalutamide plus ADT ( P < .001). Patients in both treatment groups reported a high baseline level of quality of life, which was maintained over time. Grade 3 or greater adverse events were reported in 24.3% of patients who received enzalutamide plus ADT versus 25.6% of patients who received placebo plus ADT, with no unexpected adverse events. CONCLUSION Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.",2019,"Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.","['Men With Metastatic Hormone-Sensitive Prostate Cancer', 'metastatic and nonmetastatic castration-resistant prostate cancer', 'metastatic hormone-sensitive prostate cancer (mHSPC', '1,150 men with mHSPC']","['placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy', 'enzalutamide plus ADT', 'Enzalutamide plus ADT', 'placebo plus ADT', 'enzalutamide', 'Androgen Deprivation Therapy With Enzalutamide or Placebo', 'Enzalutamide with ADT', 'ARCHES']","['risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression', 'undetectable prostate-specific antigen level', 'radiographic progression-free survival', 'risk of metastatic progression or death', 'Grade 3 or greater adverse events', 'efficacy and safety', 'risk of radiographic progression or death', 'high baseline level of quality of life']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003392', 'cui_str': 'Chemotherapeutic Anticancer Drug'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0034380'}]",1150.0,0.334023,"Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Holzbeierlein', 'Affiliation': 'The University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Lille University, Lille, France.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Azad', 'Affiliation': 'Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Alcaraz', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'Hertzen Moscow Cancer Research Institute, Moscow, Russia.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Rosbrook', 'Affiliation': 'Pfizer, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'Astellas Pharma, Northbrook, IL.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Baron', 'Affiliation': 'Astellas Pharma, Leiden, the Netherlands.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Astellas Pharma, Northbrook, IL.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00799'] 574,32209798,Effect of 12-Week Interventions Involving Nordic Walking Exercise and a Modified Diet on the Anthropometric Parameters and Blood Lipid Profiles in Overweight and Obese Ex-Coal Miners.,"BACKGROUND Overweight and obesity after retirement are likely to be caused by unhealthy eating habits and the energy intake exceeding the energy expenditure. OBJECTIVES This study was designed to assess the effects of two 12-week interventions involving, respectively, either regular physical activity or a modified lower-calorie diet on the anthropometric parameters and blood lipid profiles in overweight and obese retired miners with lipid disorders. DESIGN The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm, body weight 96.6 ± 13.9 kg) were randomly assigned to 2 intervention groups: the Nordic walking group (NW), which exercised with intensity from 60 to 70% of participants' maximal heart rates for 1 h 3 times a week, and the modified diet group (MD). Modification of the diet consisted of reducing the daily energy intake by 30%, increasing the dietary content of mono- and polyunsaturated fatty acids and dietary fiber, and reducing the proportion of saturated fatty acids. The variables assessed at baseline and after 6 and 12 weeks were: anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C]). RESULTS The body weight of the participants in the NW was lower at week 12 by an average of 5 kg, BMI by 6%, FB by 19%, FM by 15%, WC by 8%, HC by 6%, and WHR by 3%. In the MD, the respective decreases were 8 kg and 8, 25, 20, 6, 2, and 7%. In the MD, the postintervention concentrations of TC and TG were within the reference range. CONCLUSION Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.",2020,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","['body weight 96.6 ± 13.9 kg', 'Overweight and Obese Ex-Coal Miners', 'overweight and obese retired miners with lipid disorders', 'The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm']","['Nordic walking group (NW', 'regular physical activity or a modified lower-calorie diet', 'Nordic Walking Exercise and a Modified Diet']","['body weight', 'anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C', 'anthropometric parameters and blood lipid profiles', 'postintervention concentrations of TC and TG']","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0341671', 'cui_str': 'Coal miner (occupation)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0240346', 'cui_str': 'Mineworkers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0452264', 'cui_str': 'Therapeutic diets (finding)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264657', 'cui_str': 'Mass content'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.014178,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland, e.sadowska-krepa@awf.katowice.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Gdańska', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Rozpara', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Biochemistry and Basic of Cosmetology, University School of Physical Education, Krakow, Poland.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Přidalová', 'Affiliation': 'Department of Natural Sciences in Kinanthropology, Faculty of Physical Culture, Palacký University, Olomouc, Czechia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bańkowski', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}]",Obesity facts,['10.1159/000506403'] 575,32033793,Mortality and Neurodevelopmental Outcomes in the Heart Rate Characteristics Monitoring Randomized Controlled Trial.,"OBJECTIVE To test whether the composite outcome of death or neurodevelopmental impairment (NDI) at 18-22 months corrected age for infants ≤1000 g at birth is decreased by continuous monitoring of heart rate characteristics during neonatal intensive care. STUDY DESIGN We studied a subset of participants enrolled in a multicenter randomized trial of heart rate characteristics monitoring. Survivors were evaluated at 18-22 months corrected age with a standardized neurologic examination and the Bayley Scales of Infant Development-III (BSID-III). NDI was defined as Gross Motor Function Classification System of >2 (moderate or severe cerebral palsy), BSID-III language or cognitive scores of <70, severe bilateral hearing impairment, and/or bilateral blindness. RESULTS The composite outcome, death or NDI, was obtained for 628 of 884 study infants (72%). The prevalence of this outcome was 44.4% (136/306) among controls (infants randomized to heart rate characteristics monitored but not displayed) and 38.9% (125/322) among infants randomized to heart rate characteristics monitoring displayed (relative risk, 0.87; 95% CI, 0.73-1.05; P = .17). Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028). The composite outcomes of death or severe CP and death or mildly low Bayley cognitive score occurred less frequently in the displayed group (P < .05). CONCLUSIONS We found no difference in the composite outcome of death or NDI for extremely preterm infants whose heart rate characteristics were and were not displayed during neonatal intensive care. Two outcomes that included mortality or a specific NDI were less frequent in the displayed group.",2020,"Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028).",['death or neurodevelopmental impairment (NDI) at 18-22\xa0months corrected age for infants ≤1000'],[],"['mortality or a specific NDI', 'Mortality and Neurodevelopmental Outcomes', 'death or NDI', 'death or severe CP and death or mildly low Bayley cognitive score', 'standardized neurologic examination and the Bayley Scales of Infant Development-III', 'Gross Motor Function Classification System of >2 (moderate or severe cerebral palsy), BSID-III language or cognitive scores of <70, severe bilateral hearing impairment, and/or bilateral blindness', 'Mortality', 'composite outcome of death or NDI']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1879328', 'cui_str': 'Blindness, Complete'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",884.0,0.263847,"Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Oregon Health and Science University, Portland, OR. Electronic address: schelonk@ohsu.edu.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Bauer', 'Affiliation': 'Department of Pediatrics, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Peralta-Carcelen', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Helderman', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Christina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Moorman', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kattwinkel', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.066'] 576,32037149,Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams.,"OBJECTIVES To determine the effect of bovine lactoferrin on prevention of late-onset sepsis (LOS) and neurodevelopment delay. STUDY DESIGN Randomized, double-blind, controlled trial in neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing bovine lactoferrin 200 mg/kg/day with placebo administered for 8 weeks. The primary outcome was the first episode of culture-proven LOS or sepsis-associated death. Neurodevelopment delay was assessed by the Mullen Scales at 24 months corrected age. RESULTS Of the 414 infants enrolled, 209 received bovine lactoferrin and 205 received placebo. LOS or sepsis-associated death occurred in 22 infants (10.5%) in the bovine lactoferrin group vs 30 (14.6%) in the placebo group; there was no difference after adjusting for hospital and birth weight; hazard ratio 0.73 (95% CI, 0.42-1.26). For infants with birth weights of <1500 g the hazard ratio was 0.69 (95% CI, 0.39-1.25). The mean age-adjusted normalized Mullen composite score at 24 months was 83.3 ± 13.6 in the bovine lactoferrin group vs 82.6 ± 13.1 in the placebo group. Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86). CONCLUSIONS Supplementation with bovine lactoferrin did not decrease the incidence of sepsis in infants with birth weights of <2000 g. Growth and neurodevelopment outcomes at 24 months of age were similar. Neonatal bovine lactoferrin supplementation had no adverse effects. TRIAL REGISTRATION ClinicalTrials.gov: NCT01525316.",2020,"Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86). ","['414 infants enrolled', 'Infants Weighing Less', 'neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing']","['Bovine Lactoferrin', 'bovine lactoferrin', 'Neonatal bovine lactoferrin supplementation', 'placebo', 'bovine lactoferrin 200\xa0mg/kg/day with placebo']","['first episode of culture-proven LOS or sepsis-associated death', 'Sepsis\xa0and Neurodevelopment Impairment', 'mean age-adjusted normalized Mullen composite score', 'LOS or sepsis-associated death', 'prevention of late-onset sepsis (LOS) and neurodevelopment delay', 'Growth outcomes and rehospitalization rates', 'bronchiolitis', 'Neurodevelopment delay', 'incidence of sepsis']","[{'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C1440867', 'cui_str': 'lactoferrin, bovine'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",414.0,0.749494,"Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86). ","[{'ForeName': 'Theresa J', 'Initials': 'TJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Instituto de Medicina Tropical ""Alexander von Humboldt"", Universidad Peruana Cayetano Heredia, Lima, Peru; Center for Infectious Diseases, School of Public Health, University of Texas Health Science Center at Houston, Houston, TX. Electronic address: Theresa.Ochoa@upch.pe.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Zegarra', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Sicilia', 'Initials': 'S', 'LastName': 'Bellomo', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Cesar P', 'Initials': 'CP', 'LastName': 'Carcamo', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cam', 'Affiliation': 'Department of Pediatrics, Hospital Nacional Alberto Sabogal, Lima, Peru.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Castañeda', 'Affiliation': 'Department of Pediatrics, Hospital Nacional Guillermo Almenara, Lima, Peru.'}, {'ForeName': 'Aasith', 'Initials': 'A', 'LastName': 'Villavicencio', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gonzales', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Rueda', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Christie G', 'Initials': 'CG', 'LastName': 'Turin', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Alonso', 'Initials': 'A', 'LastName': 'Zea-Vera', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Guillen', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Department of Mathematics, School of Science and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ewing-Cobbs', 'Affiliation': ""Department of Pediatrics and Children's Learning Institute, School of Medicine, University of Texas Health Science Center at Houston, Houston, TX.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.038'] 577,32068366,"Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients.","BACKGROUND In critically ill, mechanically ventilated patients, daily interruption of sedation has been shown to reduce the time on ventilation and the length of stay in the intensive care unit (ICU). Data on whether a plan of no sedation, as compared with a plan of light sedation, has an effect on mortality are lacking. METHODS In a multicenter, randomized, controlled trial, we assigned, in a 1:1 ratio, mechanically ventilated ICU patients to a plan of no sedation (nonsedation group) or to a plan of light sedation (i.e., to a level at which the patient was arousable, defined as a score of -2 to -3 on the Richmond Agitation and Sedation Scale [RASS], on which scores range from -5 [unresponsive] to +4 [combative]) (sedation group) with daily interruption. The primary outcome was mortality at 90 days. Secondary outcomes were the number of major thromboembolic events, the number of days free from coma or delirium, acute kidney injury according to severity, the number of ICU-free days, and the number of ventilator-free days. Between-group differences were calculated as the value in the nonsedation group minus the value in the sedation group. RESULTS A total of 710 patients underwent randomization, and 700 were included in the modified intention-to-treat analysis. The characteristics of the patients at baseline were similar in the two trial groups, except for the score on the Acute Physiology and Chronic Health Evaluation (APACHE) II, which was 1 point higher in the nonsedation group than in the sedation group, indicating a greater chance of in-hospital death. The mean RASS score in the nonsedation group increased from -1.3 on day 1 to -0.8 on day 7 and, in the sedation group, from -2.3 on day 1 to -1.8 on day 7. Mortality at 90 days was 42.4% in the nonsedation group and 37.0% in the sedated group (difference, 5.4 percentage points; 95% confidence interval [CI], -2.2 to 12.2; P = 0.65). The number of ICU-free days and of ventilator-free days did not differ significantly between the trial groups. The patients in the nonsedation group had a median of 27 days free from coma or delirium, and those in the sedation group had a median of 26 days free from coma or delirium. A major thromboembolic event occurred in 1 patient (0.3%) in the nonsedation group and in 10 patients (2.8%) in the sedation group (difference, -2.5 percentage points; 95% CI, -4.8 to -0.7 [unadjusted for multiple comparisons]). CONCLUSIONS Among mechanically ventilated ICU patients, mortality at 90 days did not differ significantly between those assigned to a plan of no sedation and those assigned to a plan of light sedation with daily interruption. (Funded by the Danish Medical Research Council and others; NONSEDA ClinicalTrials.gov number, NCT01967680.).",2020,"Mortality at 90 days was 42.4% in the nonsedation group and 37.0% in the sedated group (difference, 5.4 percentage points; 95% confidence interval [CI], -2.2 to 12.2; P = 0.65).","['mechanically ventilated ICU patients to a plan of no sedation (nonsedation group) or to a plan of light sedation (i.e., to a level at which the patient was arousable, defined as a score of -2 to -3 on the Richmond Agitation and Sedation Scale [RASS], on which scores range from -5 [unresponsive] to +4 [combative', '710 patients underwent randomization, and 700 were included in the modified intention-to-treat analysis', 'Critically Ill, Mechanically Ventilated Patients']",['Nonsedation or Light Sedation'],"['Mortality', 'mortality', 'number of ICU-free days and of ventilator-free days', 'Acute Physiology and Chronic Health Evaluation (APACHE', 'major thromboembolic event', 'number of major thromboembolic events, the number of days free from coma or delirium, acute kidney injury according to severity, the number of ICU-free days, and the number of ventilator-free days', 'median of 26 days free from coma or delirium', 'mortality at 90 days', 'chance of in-hospital death', 'median of 27 days free from coma or delirium', 'mean RASS score']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0243030', 'cui_str': 'Acute Physiology and Chronic Health Evaluation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",710.0,0.164257,"Mortality at 90 days was 42.4% in the nonsedation group and 37.0% in the sedated group (difference, 5.4 percentage points; 95% confidence interval [CI], -2.2 to 12.2; P = 0.65).","[{'ForeName': 'Hanne T', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Helene K', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Oxlund', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Karl-Andre', 'Initials': 'KA', 'LastName': 'Wian', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Ytrebø', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Bjørn A', 'Initials': 'BA', 'LastName': 'Kroken', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chew', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Korkmaz', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'From the Departments of Anesthesiology and Intensive Care, Odense University Hospital-Svendborg Hospital, Svendborg (H.T.O.), the Departments of Clinical Research (H.T.O., H.K.N., T.S., J.O., P.T.) and Business and Economics (S.K., J.T.L.), University of Southern Denmark, and the Department of Anesthesiology and Intensive Care, Odense University Hospital (T.S., P.T.), Odense, the Department of Anesthesiology and Intensive Care, Hospital Lillebaelt, Kolding (H.K.N.), and the Department of Anesthesiology and Intensive Care, Esbjerg Hospital, Esbjerg (J.O.) - all in Denmark; the Department of Anesthesiology and Intensive Care, Vestfold Hospital, Tønsberg (K.-A.W.), and the Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø (L.M.Y., B.A.K.) - both in Norway; and the Department of Anesthesiology and Intensive Care, Linköping University Hospital, Linköping, Sweden (M.C.).'}]",The New England journal of medicine,['10.1056/NEJMoa1906759'] 578,32169523,Mechanisms of Action for Empirically Supported Interventions to Reduce Adolescent Sexual Risk Behavior: A Randomized Controlled Trial.,"PURPOSE Adolescents are at high risk for sexually transmitted infections, including HIV. Interventions to reduce adolescent sexual risk often have modest outcomes. Understanding of the mechanisms of program effectiveness is needed to develop stronger interventions. We used a randomized controlled trial to examine mechanisms of response to two empirically supported interventions: motivational interviewing versus behavioral skills training. METHODS A total of 262 adolescents (mean age = 15.89 years, standard deviation = 1.24; 34% female and 61% Latinx) were recruited from juvenile justice programs in the U.S.; all youth were randomized to motivational interviewing or behavioral skills training. Primary outcomes included (1) theory-based mechanisms (condom use attitudes, norms, self-efficacy, and intentions measured before and immediately after the interventions); and (2) risky sexual behavior (frequency of unprotected sex) and condom use measured 3 months postintervention. RESULTS Both interventions significantly increased positive attitudes toward condom use, self-efficacy for condom use, and intentions to use condoms post-test, with no differences by condition. Neither intervention impacted norms for condom use. Both interventions significantly decreased risky sexual behavior and increased condom use at the 3-month follow-up. The pattern of associations of Theory of Planned Behavior constructs to behavior were of similar magnitude in the two groups. CONCLUSIONS The results indicate common mechanisms of action for these two interventions and support the use of transdiagnostic mechanisms of treatment impact for sexual risk reduction.",2020,"Both interventions significantly increased positive attitudes toward condom use, self-efficacy for condom use, and intentions to use condoms post-test, with no differences by condition.","['262 adolescents (mean age\xa0= 15.89 years, standard deviation\xa0= 1.24', ' 34% female and 61% Latinx) were recruited from juvenile justice programs in the U.S.; all youth', 'Adolescent Sexual Risk Behavior']","['motivational interviewing or behavioral skills training', 'interventions: motivational interviewing versus behavioral skills training']","['1) theory-based mechanisms (condom use attitudes, norms, self-efficacy, and intentions measured before and immediately after the interventions); and (2) risky sexual behavior (frequency of unprotected sex) and condom use measured 3 months postintervention', 'risky sexual behavior', 'positive attitudes toward condom use, self-efficacy for condom use, and intentions to use condoms post-test']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517496', 'cui_str': '1.24'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3146221', 'cui_str': 'Juvenile (finding)'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",262.0,0.0476331,"Both interventions significantly increased positive attitudes toward condom use, self-efficacy for condom use, and intentions to use condoms post-test, with no differences by condition.","[{'ForeName': 'Laurel P', 'Initials': 'LP', 'LastName': 'Gibson', 'Affiliation': 'Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, Colorado. Electronic address: Laurel.Gibson@colorado.edu.'}, {'ForeName': 'Charleen J', 'Initials': 'CJ', 'LastName': 'Gust', 'Affiliation': 'Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Arielle S', 'Initials': 'AS', 'LastName': 'Gillman', 'Affiliation': 'Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, Colorado; Institute of Cognitive Science, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Division of Clinical Psychology, School of Medicine, Oregon Health and Science University, Portland, Oregon.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.01.004'] 579,30717746,Changes in diet quality and home food environment in preschool children following weight management.,"BACKGROUND Family-based obesity treatment interventions can successfully reduce energy intake in preschoolers. An implicit goal of obesity treatment interventions is to improve diet quality, but diet quality has been less examined as a treatment outcome in studies of preschoolers. The purpose of this study was to conduct a secondary analysis comparing the change in diet quality and home food environment in preschoolers assigned to a behavioral family-based obesity intervention (LAUNCH), motivational interviewing (MI) condition, or standard care (STC) condition. METHODS Three 24-h dietary recalls were completed at baseline and 6-months and were analyzed using NDS-R software; diet quality was assessed using the Healthy Eating Index-2010 (HEI-2010). Availability of foods and beverages in the home was assessed through direct observation using the Home Health Environment tool that classifies foods and beverages as 'red' or 'green' based upon fat and sugar content. Repeated measures linear mixed effects models were used to examine changes in diet quality and home food environment between conditions (LAUNCH, MI, STC). RESULTS At 6-months, preschoolers in the LAUNCH condition had a higher HEI-2010 total score (62.8 ± 13.7) compared to preschoolers in the MI (54.7 ± 13.4, P = 0.022) and STC (55.8 ± 11.6, P = 0.046) conditions. Regarding the home food environment, families in LAUNCH had significantly less 'red' foods in their home at 6-months (12.5 ± 3.4 'red' foods) compared to families in MI (14.0 ± 3.7 'red' foods, P = 0.030), and STC (14.3 ± 3.4 'red' foods, P = 0.006). There were no statistically significant differences across home food environments for number of 'green' foods. CONCLUSION Family-based obesity treatment interventions for preschoolers can improve overall diet quality and alter the home food environment through reductions in 'red' foods. TRIAL REGISTRATION Clinicaltrials.gov, NCT01546727 . Registered March 7, 2012.",2019,"Regarding the home food environment, families in LAUNCH had significantly less 'red' foods in their home at 6-months (12.5 ± 3.4 'red' foods) compared to families in MI (14.0 ± 3.7 'red' foods, P = 0.030), and STC (14.3 ± 3.4 'red' foods, P = 0.006).","['preschool children following weight management', 'preschoolers']","['behavioral family-based obesity intervention (LAUNCH), motivational interviewing (MI) condition, or standard care (STC) condition']","['HEI-2010 total score', 'diet quality', 'overall diet quality', 'diet quality and home food environment between conditions (LAUNCH, MI, STC']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0288201,"Regarding the home food environment, families in LAUNCH had significantly less 'red' foods in their home at 6-months (12.5 ± 3.4 'red' foods) compared to families in MI (14.0 ± 3.7 'red' foods, P = 0.030), and STC (14.3 ± 3.4 'red' foods, P = 0.006).","[{'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Robson', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware, 26 N College Avenue, Newark, DE, 19716, USA. robson@udel.edu.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Ziegler', 'Affiliation': 'Biostatistics Core, College of Health Sciences, University of Delaware, 540 S. College Avenue, Newark, DE, 19713, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'McCullough', 'Affiliation': 'Psychology Department, Suffolk University, 73 Tremont Street, Boston, MA, 02108, USA.'}, {'ForeName': 'Cathleen Odar', 'Initials': 'CO', 'LastName': 'Stough', 'Affiliation': 'Department of Psychology, University of Cincinnati, 47 W Corry Blvd Edwards 1 Bldg Suite 4130, P.O. Box 210376, Cincinnati, OH, 45219, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Zion', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue MLC 3015, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Simon', 'Affiliation': ""Department of Pediatrics, Division of Pulmonary Medicine, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, 13123 E 16th Ave B395 Aurora, Aurora, CO, 80045, USA.""}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ittenbach', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Stark', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue MLC 3015, Cincinnati, OH, 45229, USA.""}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-019-0777-6'] 580,30892637,Pharmacokinetic Profile of Spectrum Reduced Nicotine Cigarettes.,"INTRODUCTION Spectrum research cigarettes have been developed with varying nicotine content for use in studies evaluating the effects of a regulatory policy reducing the permissible nicotine content in cigarettes. This study aimed to characterize the nicotine pharmacokinetic profile of Spectrum cigarettes. METHODS Twelve daily smokers attended four sessions and had blood nicotine, exhaled carbon monoxide, and subjective effects measured before and after smoking either a single cigarette of their preferred brand or high (10.9 mg/cigarette), medium (3.2 mg/cigarette), or low (0.2 mg/cigarette) nicotine content Spectrum research cigarettes, in a double-blind design with order counterbalanced. RESULTS The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9, and 17.3 ng/mL for low-, medium-, and high-nicotine content Spectrum cigarettes. The high dose Spectrum had a similar nicotine boost to the ""preferred brand"" cigarettes (19 ng/mL). Subjects took longer puffs on the low nicotine cigarettes, but smoked these cigarettes faster than other cigarette types. High nicotine Spectrum cigarettes reduced the urge to smoke more than other cigarette types. CONCLUSIONS This study shows that Spectrum research cigarettes produce blood nicotine absorption in a dose-dependent manner, and therefore, are appropriate for use in studies of nicotine reduction in cigarettes. IMPLICATIONS This is the first study to determine the pharmacokinetic profile of Spectrum reduced nicotine content research cigarettes following an overnight abstinence. These data could provide evidence to regulatory agencies about the effects of reduced nicotine cigarettes when considering regulations on tobacco reduction.",2020,"The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9 and 17.3 ng/ml for low, medium, and high nicotine content Spectrum cigarettes.","['12 daily smokers attended 4 sessions and had blood nicotine, exhaled carbon monoxide (CO) and subjective effects measured before and after smoking either a single cigarette of their preferred brand or high (10.9 mg/cig']","['medium (3.2 mg/cig) or very low (0.2 mg/cig) nicotine content Spectrum research cigarettes, in a double-blind design with order counter-balanced', 'nicotine Spectrum cigarettes']",['blood nicotine concentration'],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0005768'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0035168'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0005768'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0278229,"The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9 and 17.3 ng/ml for low, medium, and high nicotine content Spectrum cigarettes.","[{'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Kamens', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Constanza P', 'Initials': 'CP', 'LastName': 'Silva', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Russell T', 'Initials': 'RT', 'LastName': 'Nye', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Carley N', 'Initials': 'CN', 'LastName': 'Miller', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Nayantara', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sipko', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Trushin', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Dongxiao', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmacology, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Branstetter', 'Affiliation': 'Biobehavioral Health Department, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Muscat', 'Affiliation': 'Penn State Cancer Institute, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Richie', 'Affiliation': 'Penn State Cancer Institute, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Penn State Cancer Institute, Pennsylvania State University, Hershey, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz045'] 581,30590810,Comparative Effectiveness of Group-Delivered Acceptance and Commitment Therapy versus Cognitive Behavioral Therapy for Smoking Cessation: A Randomized Controlled Trial.,"INTRODUCTION Preliminary trial data suggest group-delivered acceptance and commitment therapy (ACT) might be effective for smoking cessation. If so, this could offer a viable alternative to mainstream behavioral therapies, such as those grounded in cognitive behavioral therapy (CBT). The goal of the current study was to compare the effectiveness of group-delivered ACT versus group-delivered CBT in a rigorous randomized trial design with long-term follow-up. METHODS Participants (n = 450) were recruited from the Kaiser Permanente Washington health care system and randomized to either ACT-based group counseling or an attention-matched CBT-based group program. All were prescribed an 8-week course of nicotine patches. The primary outcome was self-reported 30-day point prevalence abstinence at 12 months post-randomization assessed with missing values imputed as smoking. Sensitivity analyses using multiple imputation and complete cases were examined, as were biochemically confirmed and 6-month outcomes. RESULTS Thirty-day point prevalence abstinence rates at the 12-month follow-up did not differ between study arms in the primary analysis (13.8% ACT vs. 18.1% CBT, adjusted odds ratio = 0.68 [95% CI = 0.35 to 1.27], p = .23) or the sensitivity analyses. CONCLUSIONS Group-based ACT and CBT had similar long-term quit rates in this methodologically rigorous randomized trial. Group-based ACT is a reasonable alternative to group-based CBT for smoking cessation. IMPLICATIONS This study compared the effectiveness of group-based ACT with group-based CBT for smoking cessation using a rigorous, large-scale, attention-matched, randomized trial with 1-year follow-up. One-year cessation rates did not differ between group-based ACT and CBT, suggesting ACT-based intervention is a reasonable alternative to CBT-based counseling for smoking cessation. The results add to the nascent but growing literature assessing ACT and other mindfulness-based treatments for smoking cessation.",2020,"Thirty-day point prevalence abstinence rates at the 12-month follow up did not differ between study arms in the primary analysis (13.8% ACT vs. 18.1% CBT, adjusted OR 0.68","['Methods\n\n\nParticipants (n = 450) were recruited from the Kaiser Permanente Washington health care system and randomized to either', 'Smoking Cessation']","['ACT versus group-delivered CBT', 'group-based ACT with group-based CBT', 'ACT-based group counseling or an attention-matched CBT-based group program', 'Group-Delivered Acceptance and Commitment Therapy vs. Cognitive Behavioral Therapy', 'nicotine patches', 'Acceptance and Commitment Therapy (ACT']","['prevalence abstinence rates', 'self-reported 30-day point prevalence abstinence (PPA']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",450.0,0.0623665,"Thirty-day point prevalence abstinence rates at the 12-month follow up did not differ between study arms in the primary analysis (13.8% ACT vs. 18.1% CBT, adjusted OR 0.68","[{'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (Formerly, Group Health Research Institute), Seattle, WA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bricker', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mull', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty268'] 582,30605397,Effects of active commuting and leisure-time exercise on appetite in individuals with overweight and obesity.,"Acute exercise is associated with a transient suppression of appetite. The effects of regular exercise on appetite are not well understood. We aimed to determine the effects of active commuting and leisure-time exercise on appetite. One hundred thirty physically inactive women and men (20-45 yr) with overweight and obesity were randomized to 6 mo of habitual lifestyle (CON, n = 18), active commuting (BIKE, n = 35), or leisure-time exercise of moderate [MOD, 50% peak oxygen uptake (V̇o 2peak )-reserve, n = 39] or vigorous (VIG, 70% V̇o 2peak -reserve, n = 38) intensity. Appetite ratings, acylated ghrelin, cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and glucagon were assessed in the basal state and in response to meal and exercise challenges at baseline and 3 and 6 mo. Ad libitum energy intake was determined during test meals. Data from 90 participants (per protocol) were available, and results are comparisons with CON. At 3 mo, ad libitum energy intake was lower in VIG (-22%, P < 0.01), basal glucagon was lower in BIKE ( P < 0.05) and VIG ( P = 0.01), and postprandial ratings of prospective food consumption were lower in MOD ( P = 0.02) and VIG ( P < 0.001). In VIG, ratings of hunger ( P = 0.01) and prospective food consumption ( P = 0.03) were lower after acute exercise at 3 mo. At 6 mo, basal and postprandial GLP-1 were higher ( P ≤ 0.04) whereas postexercise PYY was lower ( P = 0.03) in VIG and postexercise CCK was lower in BIKE ( P = 0.03). Vigorous-intensity exercise training leads to a transient suppression of energy intake and subjective appetite (3 mo) but a more long-term increase in basal and postprandial GLP-1 (6 mo) in individuals with overweight and obesity. NEW & NOTEWORTHY This is the first randomized controlled trial, to our knowledge, investigating long-term effects of exercise domain and intensity on subjective and hormonal markers of appetite and ad libitum energy intake in individuals with overweight and obesity. Appetite was assessed in response to meal and exercise challenges at baseline and at 3 and 6 mo. Anorexigenic effects of exercise vary with the duration of intervention and are restricted to regular leisure-time exercise of vigorous intensity in individuals with overweight and obesity.",2019,"At 3 mo, ad libitum energy intake was lower in VIG (-22%, P < 0.01), basal glucagon was lower in BIKE ( P < 0.05) and VIG ( P = 0.01), and postprandial ratings of prospective food consumption were lower in MOD ( P = 0.02) and VIG ( P < 0.001).","['individuals with overweight and obesity', 'One hundred thirty physically inactive women and men (20-45 yr) with overweight and obesity']","['Vigorous-intensity exercise training', 'habitual lifestyle (CON, n = 18), active commuting (BIKE, n = 35), or leisure-time exercise of moderate [MOD, 50% peak oxygen uptake (V̇o 2peak )-reserve, n = 39] or vigorous (VIG, 70% V̇o 2peak -reserve, n = 38) intensity', 'active commuting and leisure-time exercise', 'regular exercise']","['basal and postprandial GLP-1', 'Appetite', 'Ad libitum energy intake', 'VIG and postexercise CCK', 'Appetite ratings, acylated ghrelin, cholecystokinin (CCK), glucagon-like peptide-1', 'GLP-1), peptide YY (PYY), and glucagon', 'VIG, ratings of hunger', 'prospective food consumption', 'postprandial ratings of prospective food consumption', 'basal glucagon']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1505513', 'cui_str': 'CCK(58)(ns)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0008328', 'cui_str': 'pancreozymin (cholecystokinin)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",130.0,0.0342591,"At 3 mo, ad libitum energy intake was lower in VIG (-22%, P < 0.01), basal glucagon was lower in BIKE ( P < 0.05) and VIG ( P = 0.01), and postprandial ratings of prospective food consumption were lower in MOD ( P = 0.02) and VIG ( P < 0.001).","[{'ForeName': 'Jonas Salling', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Martin Bæk', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Gram', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Carina Bjørnskov', 'Initials': 'CB', 'LastName': 'Steenholt', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Janus', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital , Copenhagen , Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Stallknecht', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00239.2018'] 583,30653413,Impact of 24 weeks of supervised endurance versus resistance exercise training on left ventricular mechanics in healthy untrained humans.,"In addition to the well-known cardiac structural adaptation to exercise training, little work has examined changes in left ventricle (LV) mechanics. With new regional and global indexes available we sought to determine the effect of 24-wk endurance versus resistance training on LV mechanics. Twenty-three male subjects were randomly allocated to a 24-wk endurance or resistance training program. Pre- and posttraining two-dimensional echocardiographic images were acquired. Global LV mechanics [strain (ε)] were recorded in longitudinal, circumferential, and radial planes. Rotation was assessed at apical and basal levels. In addition, longitudinal ε-volume loops, across the cardiac cycle, were constructed from simultaneous LV ε (longitudinal and transverse strain) and volume measurements across the cardiac cycle as a novel measure of LV mechanics. Marginal differences in ε and rotation data were found between groups. After training, we found no change in global peak ε data. Peak basal rotation significantly increased after training, with changes in the endurance group (-2.2 ± 1.9° to -4.5 ± 3.3°) and the resistance group (-2.9 ± 3.0° to -3.4 ± 2.9°). LV ε-volume loops revealed a modest rightward shift in both groups. Although most global and regional indexes of LV mechanics were not significantly altered, 24 wk of intense supervised exercise training increased basal rotation. Further studies that assess LV mechanics in larger cohorts of subjects and those with cardiovascular disease and risk factors may reveal important training impacts. NEW & NOTEWORTHY This study builds on previous work by our group and presents a comprehensive assessment of cardiac mechanics after dichotomous exercise training programs. We highlight novel findings in addition to the inclusion of strain-volume loops, which shed light on subtle differences in longitudinal and transverse contribution to volume change throughout the cardiac cycle. Our findings suggest that training has an impact on basal rotation and possibly strain-volume loops.",2019,"Peak basal rotation significantly increased after training, with changes in the endurance group (-2.2 ± 1.9° to -4.5 ± 3.3°) and the resistance group (-2.9 ± 3.0° to -3.4 ± 2.9°).","['Twenty-three male subjects', 'healthy untrained humans']","['24-wk endurance versus resistance training', 'supervised endurance versus resistance exercise training', 'dichotomous exercise training programs', 'supervised exercise training', '24-wk endurance or resistance training program']","['LV mechanics', 'Peak basal rotation', 'Global LV mechanics [strain (ε', 'basal rotation']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]",23.0,0.0280383,"Peak basal rotation significantly increased after training, with changes in the endurance group (-2.2 ± 1.9° to -4.5 ± 3.3°) and the resistance group (-2.9 ± 3.0° to -3.4 ± 2.9°).","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Oxborough', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University , Liverpool , United Kingdom.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'School of Human Sciences (Exercise and Sports Science), The University of Western Australia , Nedlands, Western Australia , Australia.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'George', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University , Liverpool , United Kingdom.'}, {'ForeName': 'Frederieke', 'Initials': 'F', 'LastName': 'Van Oorschot', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University , Liverpool , United Kingdom.'}, {'ForeName': 'Dick H T', 'Initials': 'DHT', 'LastName': 'Thijssen', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University , Liverpool , United Kingdom.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sports Science), The University of Western Australia , Nedlands, Western Australia , Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00405.2018'] 584,30521040,Pediatric Office Delivery of Smoking Cessation Assistance for Breast-Feeding Mothers.,"INTRODUCTION National and international organizations have done an excellent job of advocating and promoting breast feeding for all mothers. This study assessed to what extent an intervention increased delivery of cessation assistance to breast-feeding mothers who smoke. METHODS Data were collected between April and October 2015 in five US states as part of a cluster randomized controlled trial in 10 pediatric practices. Practices were randomized to the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention or usual care control arms. Mothers were asked about their smoking status and breast-feeding history during a screening interview upon exiting the practice and eligible mothers who agreed to participate in an enrollment interview were asked if they received smoking cessation assistance during their child's visit. Mothers with a child 1 year old and younger were included in the analyses. RESULTS Current breast feeding was associated with a reduced likelihood of current smoking (adjusted odds ratio [aOR] = 0.38, 95% confidence interval [95% CI] = 0.25 to 0.57) and a greater likelihood of quitting smoking (aOR = 2.33, 95% CI = 1.29 to 4.21) after controlling for known confounders. Mothers who concurrently smoked and breast-fed were more likely to be asked about smoking (66.7% vs. 28.6%, p = .01), advised to quit (61.1% vs. 21.4%, p < .01), prescribed nicotine replacement therapy (50.0% vs. 0%, p < .001), and enrolled into the quitline (27.8% vs. 0%, p < .01) at CEASE practices compared to control practices. CONCLUSION Breast-feeding mothers were less likely to be current smokers and more likely to have recently quit smoking. Among mothers who continue to smoke and breast feed, the CEASE intervention enhances delivery of smoking cessation assistance. IMPLICATIONS Breast feeding and eliminating infants' exposure to tobacco smoke are important protective factors for serious pediatric health risks including sudden infant death. This study shows that breast feeding was positively associated with desirable tobacco control outcomes, specifically that breast feeding was associated with a lower likelihood of smoking among ever smokers and a greater likelihood of recently quitting smoking. This is also the first study to look specifically at delivery of smoking cessation assistance to breast-feeding mothers seen at pediatric offices and demonstrates the effectiveness of delivering evidence-based smoking cessation assistance to them in this context. TRIAL REGISTRATION www.ClinicalTrials.gov (identifier NCT01882348).",2020,"Results Current breast feeding was associated with a reduced likelihood of current smoking (adjusted odds ratio [aOR] = 0.38, 95% confidence interval [95% CI] = 0.25 to 0.57) and a greater likelihood of quitting smoking (aOR = 2.33, 95% CI = 1.29 to 4.21) after controlling for known confounders.","['10 pediatric practices', 'breast-feeding mothers who smoke', 'Breast-Feeding Mothers', 'Mothers with a child 1 year old and younger were included in the analyses']","['screening interview upon exiting the practice and eligible mothers who agreed to participate in an enrollment interview were asked if they received smoking cessation assistance', 'CEASE intervention', 'Secondhand Smoke Exposure (CEASE) intervention or usual care control arms', 'Smoking Cessation Assistance']","['likelihood of quitting smoking', 'advised to quit', 'reduced likelihood of current smoking']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0037370', 'cui_str': 'Smoking, Passive'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",10.0,0.0320412,"Results Current breast feeding was associated with a reduced likelihood of current smoking (adjusted odds ratio [aOR] = 0.38, 95% confidence interval [95% CI] = 0.25 to 0.57) and a greater likelihood of quitting smoking (aOR = 2.33, 95% CI = 1.29 to 4.21) after controlling for known confounders.","[{'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Drehmer', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, MA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Ossip', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Emara', 'Initials': 'E', 'LastName': 'Nabi-Burza', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, MA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Hipple Walters', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, MA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Gorzkowski', 'Affiliation': 'Julius B. Richmond Center of Excellence, American Academy of Pediatrics, Itasca, IL.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Winickoff', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, MA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty247'] 585,30535269,"Does Smoking Intensity Predict Cessation Rates? A Study of Light-Intermittent, Light-Daily, and Heavy Smokers Enrolled in Two Telephone-Based Counseling Interventions.","INTRODUCTION Though many interventions have been shown to be effective in helping smokers quit, outcomes may differ between light and heavy smokers. We identified differences in baseline characteristics and post-intervention cessation rates among smoker groups at two safety-net hospitals. METHODS We retrospectively analyzed cessation rates in 1604 patients randomized to either a quitline referral (1-2 telephone counseling sessions) or intensive counseling program (seven telephone sessions). Participants were stratified into light-intermittent (smoked on ≤24 of last 30 days), light-daily (smoked on >24/30 days, 1-9 cigarettes per day [CPD]), or heavy smokers (smoked on >24/30 days, ≥10 CPD). We compared baseline characteristics between smoker types using chi-squared tests, then identified predictors of 30-day abstinence using a multivariable model. RESULTS Compared with light-daily and light-intermittent smokers, heavy smokers were more likely to be white, male, concomitant e-cigarette users, to have high-risk alcohol use, to have used quitting aids previously, to have current or lifetime substance use (excluding cannabis), and have lower confidence in quitting. However, in multivariable analysis, smoker type was not significantly associated with cessation. The statistically significant predictors of cessation at 6 months were higher confidence in quitting and enrollment in the intensive counseling intervention. CONCLUSIONS Smoker type (light-intermittent, light-daily, or heavy) does not independently predict success in a cessation program. However, smoker type is strongly associated with patients' confidence in quitting, which may be one predictor of cessation. IMPLICATIONS This study of two safety-net hospitals emphasizes that the number of cigarettes smoked per day does not independently predict smoking cessation. Additionally, heavy smokers are at highest risk for the detrimental health effects of tobacco, yet have lower confidence and motivation to quit. Confidence in quitting may be one factor that affects cessation rates; however, further study is needed to identify which other attributes predict cessation. These findings suggest that smoker type may still be a useful proxy for predicting cessation and that interventions specifically designed for and validated in heavy smokers are needed to better aid these individuals.",2020,"However, in multivariable analysis, smoker type was not significantly associated with cessation.","['heavy smokers enrolled in two', '1,604 patients randomized to either a', 'heavy smokers']","['light-intermittent, light-daily', 'quitline referral (1-2 telephone counseling sessions) or intensive counseling program', 'telephone-based counseling interventions']",[],"[{'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0438507,"However, in multivariable analysis, smoker type was not significantly associated with cessation.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ni', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Binhuan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Alissa R', 'Initials': 'AR', 'LastName': 'Link', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York, NY.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty257'] 586,31070741,Effect of a Responsiveness-Based Support Intervention on Smokeless Tobacco Cessation: The UCare-ChewFree Randomized Clinical Trial.,"INTRODUCTION Partner behaviors and attitudes can motivate or undermine a tobacco user's cessation efforts. We developed a multimedia intervention, UCare (Understanding-CAring-REspect) for women who wanted their male partner to quit smokeless tobacco (ST), based on perceived partner responsiveness-the empirically based theory that support is best received when the supporter conveys respect, understanding, and caring. METHODS One thousand one hundred three women were randomized to receive either immediate access to the UCare website and printed booklet (Intervention; N = 552), or a Delayed Treatment control (N = 551). We assessed supportive behaviors and attitudes at baseline and 6-week follow-up, and the ST-using partner's abstinence at 6 weeks and 7.5 months (surrogate report). RESULTS For partners of women assigned to Intervention, 7.0% had quit all tobacco at 7.5 months, compared with 6.6% for control (χ2 (1, n = 1088) = .058, p = .810). For partners of women completing the intervention, 12.4% had quit all tobacco at 7.5 months, compared with 6.6% for Delayed Treatment (χ2 (1, n = 753) = 6.775, p = .009). A previously reported change in responsiveness-based behaviors and instrumental behaviors at 6 weeks mediated 7.5-month cessation, and change in responsiveness-based attitudes mediated the change in responsiveness-based behaviors, indirectly increasing cessation. CONCLUSIONS A responsiveness-based intervention with female partners of male ST users improved supportive attitudes and behaviors, leading to higher cessation rates among tobacco users not actively seeking to quit. The study demonstrates the potential for responsiveness as a basis for effective intervention with supporters. This approach may reach tobacco users who would not directly seek help. IMPLICATIONS This study demonstrates the value of a responsiveness-based intervention (showing respect, understanding, and caring) in training partners to provide support for a loved one to quit ST. In a randomized clinical trial, 1,103 women married to or living with a ST user were randomized to receive the UCare-ChewFree intervention (website + booklet) or a Delayed Treatment control. Women completing the intervention were more likely to improve their behaviors and attitudes, and change in behaviors and attitudes mediated cessation outcomes for their partners, who had not enrolled in the study and may not have been seeking to quit. TRIAL REGISTRATION ClinicalTrials.gov NCT01885221.",2020,"Women completing the intervention were more likely to improve their behaviors and attitudes, and change in behaviors and attitudes mediated cessation outcomes for their partners, who had not enrolled in the study and may not have been seeking to quit.","['women who wanted their male partner to quit smokeless tobacco', '1,103 women married to or living with a smokeless tobacco user', 'female partners of male smokeless tobacco users', '1,103 women']","['UCare-ChewFree intervention (website + booklet) or a delayed treatment control', 'multimedia intervention, UCare (Understanding-CAring-REspect', 'immediate access to the UCare website and printed booklet (Intervention; N=552), or a Delayed Treatment control (N=551', 'Responsiveness-based support intervention']","['smokeless tobacco cessation', 'supportive attitudes and behaviors', 'responsiveness-based behaviors and instrumental behaviors', 'behaviors and attitudes, and change in behaviors and attitudes mediated cessation outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0555047', 'cui_str': 'Married (finding)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0600550', 'cui_str': 'Smokeless Tobacco Cessation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0542299', 'cui_str': 'Altered behavior'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]",1103.0,0.0687025,"Women completing the intervention were more likely to improve their behaviors and attitudes, and change in behaviors and attitudes mediated cessation outcomes for their partners, who had not enrolled in the study and may not have been seeking to quit.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Akers', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Andrews', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lichtenstein', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Gordon', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz074'] 587,30611694,Effect of One-Suture and Sutureless Techniques on Postoperative Healing After Third Molar Surgery.,"PURPOSE The wound closure technique for lower third molar surgery (LTMS) is an operative factor that influences wound healing and the occurrence of early postoperative complications. The present study investigated 2 closure techniques (partial closure using 1 suture and the suture-less technique) after use of a modified buccal envelope flap for LTMS. MATERIALS AND METHODS We performed a prospective, randomized, double-blind, split-mouth, controlled trial. Partial closure using 1 suture was compared with closure using the sutureless technique. The surgical sites were divided into 2 groups, group A (1 suture) and group B (sutureless). Each patient received both treatments at the same surgery. During the first postoperative week, all patients were asked to daily assess pain, facial swelling, and bleeding using self-assessment scales. All patients attended the follow-up appointment at 1 week to objectively assess facial swelling and wound healing and at 1 month to assess wound healing. An analysis of data was performed using the statistical package SPSS Statistics, version 24 (IBM Corp, Armonk, NY). A P value ≤ .05 was accepted as statistically significant. RESULTS A total of 37 patients with bilateral impacted third molars of similar surgical difficulty were recruited. Of the 37 patients, 34 successfully completed the study. The results showed a statistically significant difference between the 2 techniques in postoperative pain at days 5 (P = .046) and 6 (P = .034); socket healing at 1 week (P = .002) and 1 month (P = .014), and soft tissue healing at 1 week (P = .016). CONCLUSION We found the 1-suture technique for LTMS to be superior to the sutureless technique in the reduction of postoperative pain and improving wound healing during the early postoperative period. We found no difference between the 2 techniques in the reduction of postoperative swelling.",2019,"The results showed a statistically significant difference between the 2 techniques in postoperative pain at days 5 (P = .046) and 6 (P = .034); socket healing at 1 week (P = .002) and 1 month (P = .014), and soft tissue healing at 1 week (P = .016). ","['37 patients with bilateral impacted third molars of similar surgical difficulty were recruited', '37 patients, 34 successfully completed the study']","['One-Suture and Sutureless Techniques', 'Partial closure using 1 suture was compared with closure using the sutureless technique', 'closure techniques (partial closure using 1 suture and the suture-less technique', 'wound closure technique for lower third molar surgery (LTMS']","['postoperative pain', 'socket healing', 'facial swelling and wound healing', 'Postoperative Healing', 'postoperative pain and improving wound healing', 'postoperative swelling', 'wound healing', 'pain, facial swelling, and bleeding using self-assessment scales', 'soft tissue healing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C2936333', 'cui_str': 'Wound Closure Techniques'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0222045'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}]",37.0,0.0323322,"The results showed a statistically significant difference between the 2 techniques in postoperative pain at days 5 (P = .046) and 6 (P = .034); socket healing at 1 week (P = .002) and 1 month (P = .014), and soft tissue healing at 1 week (P = .016). ","[{'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Alkadi', 'Affiliation': 'Specialist Oral Surgeon, Department of Oral and Maxillofacial Surgery, Dublin Dental University Hospital, Lincoln Place, Dublin, Ireland. Electronic address: alkadis@tcd.ie.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Stassen', 'Affiliation': ""Professor and Chair, The National Maxillofacial Unit, St James's Hospital, Dublin, Ireland; Department of Oral and Maxillofacial Surgery, Dublin Dental University Hospital, Dublin, Ireland.""}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2018.12.001'] 588,30452739,The Network Structure of Tobacco Withdrawal in a Community Sample of Smokers Treated With Nicotine Patch and Behavioral Counseling.,"INTRODUCTION Network theories of psychopathology highlight that, rather than being indicators of a latent disorder, symptoms of disorders can causally interact with one another in a network. This study examined tobacco withdrawal from a network perspective. METHODS Participants (n = 525, 50.67% female) completed the Minnesota Tobacco Withdrawal Scale four times (2 weeks prior to a target quit day, on the target quit day, and 4 and 8 weeks after the target quit day) over the course of 8 weeks of treatment with nicotine patch and behavioral counseling within a randomized clinical trial testing long-term nicotine patch therapy in treatment-seeking smokers. The conditional dependence among seven withdrawal symptoms was estimated at each of the four measurement occasions. Influential symptoms of withdrawal were identified using centrality indices. Changes in network structure were examined using the Network Comparison Test. RESULTS Findings indicated many associations among the individual symptoms of withdrawal. The strongest associations that emerged were between sleep problems and restlessness, and associations among affective symptoms. Restlessness and affective symptoms emerged as the most central symptoms in the withdrawal networks. Minimal differences in the structure of the withdrawal networks emerged across time. CONCLUSIONS The cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal rather than simply reflecting passive indicators of a latent disorder. Findings encourage greater consideration of individual withdrawal symptoms and their potential interactions and may be used to generate hypotheses that may be tested in future intensive longitudinal studies. IMPLICATIONS This study provides a novel, network perspective on tobacco withdrawal. Drawing on network theories of psychopathology, we suggest that the cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal over time, rather than simply reflecting passive indicators of a latent disorder. Results indicating many associations among individual symptoms of withdrawal are consistent with a network perspective. Other results of interest include minimal changes in the network structure of withdrawal across four measurement occasions prior to and during treatment with nicotine patch and behavioral counseling.",2020,"Minimal differences in the structure of the withdrawal networks emerged across time. ",[],"['nicotine patch therapy', 'Nicotine Patch and Behavioral Counseling', 'nicotine patch and behavioral counseling']","['Restlessness and affective symptoms', 'Minnesota Tobacco Withdrawal Scale (MTWS']",[],"[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}]","[{'cui': 'C0542200', 'cui_str': 'Restlessness (phenothiazine)'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0222045'}]",,0.0546072,"Minimal differences in the structure of the withdrawal networks emerged across time. ","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lydon-Staley', 'Affiliation': 'Department of Bioengineering, School of Engineering and Applied Science, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Bassett', 'Affiliation': 'Department of Bioengineering, School of Engineering and Applied Science, University of Pennsylvania, Philadelphia, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty250'] 589,30500925,Impact of E-cigarette Sampling on Cigarette Dependence and Reinforcement Value.,"INTRODUCTION E-cigarettes have risen in prevalence in recent years, and most public health experts agree they deliver fewer toxicants than combustible tobacco products such as cigarettes. Thus, it is important to understand how use of e-cigarettes by current smokers impacts dependence on combustible cigarettes. METHODS The present study is a secondary analysis of a randomized pilot trial of e-cigarette sampling. Nontreatment seeking current smokers were randomized in a 2:1 ratio to either receive or not receive a weekly supply of e-cigarettes for 3 weeks. Participants completed the Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM) scale and the cigarette purchase task before and after the sampling period and at monthly follow-up visits for 3 months. RESULTS Individuals assigned to receive an e-cigarette had significantly lower mean WISDM scores at the end of sampling and the end of the follow-up period compared with those in the control group. Both frequency of e-cigarette use as well as nicotine concentration of the e-cigarette given to smokers were significant predictors of changes in the mean WISDM score. E-cigarette sampling significantly reduced the demand parameter Omax, which measures the maximum amount of money participants estimate they would spend on cigarettes in a single day. CONCLUSIONS These data suggest that current smokers who try using an e-cigarette may experience reductions in dependence on combustible cigarettes. IMPLICATIONS The present analysis suggests that providing an e-cigarette to current cigarette smokers is likely to reduce cigarette dependence, especially if the e-cigarette delivers sufficient nicotine and is used frequently.",2020,"Results Individuals assigned to receive an e-cigarette had significantly lower mean WISDM scores at the end of sampling and the end of the follow-up period compared to those in the control group.",['e-cigarette sampling. Non-treatment seeking current smokers'],['e-cigarette sampling'],"['mean WISDM scores', 'Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM) scale and the Cigarette Purchase Task (CPT', 'cigarette dependence and reinforcement value']","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3241966'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0133065,"Results Individuals assigned to receive an e-cigarette had significantly lower mean WISDM scores at the end of sampling and the end of the follow-up period compared to those in the control group.","[{'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Cancer Control and Prevention, Hollings Cancer Center, MUSC, Charleston, SC.'}, {'ForeName': 'Bryan W', 'Initials': 'BW', 'LastName': 'Heckman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Cummings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty258'] 590,32191722,Effects of oxytocin administration and conditioned oxytocin on brain activity: An fMRI study.,"It has been demonstrated that secretion of several hormones can be classically conditioned, however, the underlying brain responses of such conditioning have never been investigated before. In this study we aimed to investigate how oxytocin administration and classically conditioned oxytocin influence brain responses. In total, 88 females were allocated to one of three groups: oxytocin administration, conditioned oxytocin, or placebo, and underwent an experiment consisting of three acquisition and three evocation days. Participants in the conditioned group received 24 IU of oxytocin together with a conditioned stimulus (CS) during three acquisition days and placebo with the CS on three evocation days. The oxytocin administration group received 24 IU of oxytocin and the placebo group received placebo during all days. On the last evocation day, fMRI scanning was performed for all participants during three tasks previously shown to be affected by oxytocin: presentation of emotional faces, crying baby sounds and heat pain. Region of interest analysis revealed that there was significantly lower activation in the right amygdala and in two clusters in the left superior temporal gyrus in the oxytocin administration group compared to the placebo group in response to observing fearful faces. The activation in the conditioned oxytocin group was in between the other two groups for these clusters but did not significantly differ from either group. No group differences were found in the other tasks. Preliminary evidence was found for brain activation of a conditioned oxytocin response; however, despite this trend in the expected direction, the conditioned group did not significantly differ from other groups. Future research should, therefore, investigate the optimal timing of conditioned endocrine responses and study whether the findings generalize to other hormones as well.",2020,The activation in the conditioned oxytocin group was in between the other two groups for these clusters but did not significantly differ from either group.,['88 females'],"['oxytocin administration and conditioned oxytocin', 'placebo', 'oxytocin', 'conditioned oxytocin', 'oxytocin administration and classically conditioned oxytocin', 'oxytocin together with a conditioned stimulus (CS', 'oxytocin administration, conditioned oxytocin, or placebo']","['emotional faces, crying baby sounds and heat pain', 'brain activation', 'brain activity']","[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",88.0,0.143848,The activation in the conditioned oxytocin group was in between the other two groups for these clusters but did not significantly differ from either group.,"[{'ForeName': 'Aleksandrina', 'Initials': 'A', 'LastName': 'Skvortsova', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Mischa', 'Initials': 'M', 'LastName': 'de Rover', 'Affiliation': 'Leiden Institute for Brain and Cognition, Leiden, the Netherlands.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Pacheco-Lopez', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Bakermans-Kranenburg', 'Affiliation': 'Leiden Institute for Brain and Cognition, Leiden, the Netherlands.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van IJzendoorn', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}]",PloS one,['10.1371/journal.pone.0229692'] 591,32191755,Static stretch and dynamic muscle activity induce acute similar increase in corticospinal excitability.,"Even though the acute effects of pre-exercise static stretching and dynamic muscle activity on muscular and functional performance have been largely investigated, their effects on the corticospinal pathway are still unclear. For that reason, this study examined the acute effects of 5×20 s of static stretching, dynamic muscle activity and a control condition on spinal excitability, corticospinal excitability and plantar flexor neuromuscular properties. Fifteen volunteers were randomly tested on separate days. Transcranial magnetic stimulation was applied to investigate corticospinal excitability by recording the amplitude of the motor-evoked potential (MEP) and the duration of the cortical silent period (cSP). Peripheral nerve stimulation was applied to investigate (i) spinal excitability using the Hoffmann reflex (Hmax), and (ii) neuromuscular properties using the amplitude of the maximal M-wave (Mmax) and corresponding peak twitch torque. These measurements were performed with a background 30% of maximal voluntary isometric contraction. Finally, the maximal voluntary isometric contraction torque and the corresponding electromyography (EMG) from soleus, gastrocnemius medialis and gastrocnemius lateralis were recorded. These parameters were measured immediately before and 10 s after each conditioning activity of plantar flexors. Corticospinal excitability (MEP/Mmax) was significantly enhanced after static stretching in soleus (P = 0.001; ES = 0.54) and gastrocnemius lateralis (P<0.001; ES = 0.64), and after dynamic muscle activity in gastrocnemius lateralis (P = 0.003; ES = 0.53) only. On the other hand, spinal excitability (Hmax/Mmax), cSP duration, muscle activation (EMG/Mmax) as well as maximal voluntary and evoked torque remained unaltered after all pre-exercise interventions. These findings indicate the presence of facilitation of the corticospinal pathway without change in muscle function after both static stretching (particularly) and dynamic muscle activity.",2020,"Corticospinal excitability (MEP/Mmax) was significantly enhanced after static stretching in soleus (P = 0.001; ES = 0.54) and gastrocnemius lateralis (P<0.001; ES = 0.64), and after dynamic muscle activity in gastrocnemius lateralis (P = 0.003; ES = 0.53) only.",['Fifteen volunteers'],['Transcranial magnetic stimulation'],"['spinal excitability (Hmax/Mmax), cSP duration, muscle activation (EMG/Mmax', 'Corticospinal excitability (MEP/Mmax', 'maximal voluntary isometric contraction torque and the corresponding electromyography (EMG) from soleus, gastrocnemius medialis and gastrocnemius lateralis', 'corticospinal excitability', 'maximal voluntary and evoked torque', 'spinal excitability, corticospinal excitability and plantar flexor neuromuscular properties']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",15.0,0.0176055,"Corticospinal excitability (MEP/Mmax) was significantly enhanced after static stretching in soleus (P = 0.001; ES = 0.54) and gastrocnemius lateralis (P<0.001; ES = 0.64), and after dynamic muscle activity in gastrocnemius lateralis (P = 0.003; ES = 0.53) only.","[{'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Opplert', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Paizis', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Papitsa', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'School of Medical and Health Sciences and Centre for Exercise and Sports Science Research, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Cometti', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Babault', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}]",PloS one,['10.1371/journal.pone.0230388'] 592,30395821,Patient-Controlled Analgesia and Length of Hospital Stay in Orthognathic Surgery: A Randomized Controlled Trial.,"PURPOSE The objective of this prospective, randomized controlled pilot study of patients undergoing orthognathic surgery was to compare the hospital length of stay (LOS) in patients using intravenous patient-controlled analgesia (PCA) versus patients receiving scheduled and as-needed oral analgesia. PATIENTS AND METHODS A total of 40 patients (19 male and 21 female patients) aged 16 to 56 years (mean, 20.73 years; standard deviation, 6.87 years) were recruited prospectively and randomized to PCA and non-PCA groups of equal size. Recording of the patient-reported pain score using a visual analog scale was commenced at 8:00 am on day 1 after surgery until discharge. The pain score from routine nursing observations during the postoperative period was recorded until the patient was discharged from the hospital. RESULTS Randomization resulted in approximately equal proportions of male patients (45% vs 50%) and median ages (18.5 years vs 20 years) for the PCA group versus the non-PCA group; however, the PCA group was noted to have a higher proportion of double-jaw surgery (65% vs 40%). The median LOS was 2 days for both the PCA and non-PCA groups (P = .06). No statistically significant difference in pain scores was found between the 2 groups either at rest (P = .27) or on movement (P = .13). CONCLUSIONS No evidence was found to indicate the superiority of either the PCA or non-PCA regimen with respect to LOS and pain scores; however, this is not evidence of equivalence of the 2 pain management approaches.",2019,"No evidence was found to indicate the superiority of either the PCA or non-PCA regimen with respect to LOS and pain scores; however, this is not evidence of equivalence of the 2 pain management approaches.","['patients using intravenous patient-controlled analgesia (PCA) versus patients receiving scheduled and as-needed oral analgesia', '40 patients (19 male and 21 female patients) aged 16 to 56\xa0years (mean, 20.73\xa0years; standard deviation, 6.87\xa0years', 'Orthognathic Surgery', 'patients undergoing']","['PCA and non-PCA groups of equal size', 'orthognathic surgery', 'PCA']","['median LOS', 'proportion of double-jaw surgery', 'pain scores', 'LOS and pain scores', 'pain score', 'hospital length of stay (LOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0407713', 'cui_str': 'Jaw Surgery'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",40.0,0.154466,"No evidence was found to indicate the superiority of either the PCA or non-PCA regimen with respect to LOS and pain scores; however, this is not evidence of equivalence of the 2 pain management approaches.","[{'ForeName': 'Frank S-C', 'Initials': 'FS', 'LastName': 'Chang', 'Affiliation': 'Oral and Maxillofacial Surgeon, Department of Oral and Maxillofacial Surgery, Royal Perth Hospital, Perth, Western Australia, Australia. Electronic address: dr.frankchang@hotmail.com.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Burrows', 'Affiliation': 'Statistician, School of Medicine and Pharmacology, Royal Perth Hospital, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Dieter P', 'Initials': 'DP', 'LastName': 'Gebauer', 'Affiliation': 'Clinical Associate Professor and Head of Department of Oral and Maxillofacial Surgery, Royal Perth Hospital, Perth, Western Australia, Australia; Oral Health and Equity, Department of Human Sciences, University of Western Australia, Perth, Western Australia, Australia.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2018.10.001'] 593,30940355,Pain Reduction in Extensive Apical Surgery of the Anterior Maxilla: A Comparative Clinical Study.,"PURPOSE The purpose of this study was to compare the outcomes of 2 different anesthetic techniques (local infiltration vs infraorbital nerve block) for eliminating pain during apical surgeries that are associated with extensive periapical pathology in the anterior maxilla. MATERIALS AND METHODS Patients were randomly divided into 2 groups: patients in group I were anesthetized labially by local infiltration injections, whereas those in group II received a single infraorbital nerve block. Palatal injections were given for the 2 groups. Once the pain was initiated during surgery, the procedure was discontinued until profound anesthesia was secured. The studied variables were age, gender, onset of anesthesia, operative time, and intraoperative pain. Any complication associated with the injection techniques, intraoperatively and postoperatively, also was assessed and recorded. Then, the collected data were analyzed using proper statistical methods. The significance level was set at a P value less than or equal to .05. RESULTS One hundred patients (50 per group; age range, 16 to 43 yr), predominantly men, were enrolled in this study. The results showed rapid onset of anesthesia in group II with a highly significant difference from group I (P ≤ .05). Duration of the operation ranged from 44 to 57 minutes. Pain during the surgical procedure was reported by most patients in group I (92%). Collateral anesthesia (82%) and increased numbness of the upper lip (72%) were reported in group I. Ecchymosis at the infraorbital foramen or rim (8%) and paresthesia in the skin over the infraorbital region (6%) and cheek (4%) were observed in group II. CONCLUSIONS In apical surgeries, the anesthetic efficiency of the infraorbital nerve block was superior to that of local infiltration. It had rapid onset, longer duration, and greater potency and avoided multiple transmucosal injections. Furthermore, it was associated with minor and transient side effects.",2019,The results showed rapid onset of anesthesia in group II with a highly significant difference from group I (P ≤ .05).,"['Extensive Apical Surgery of the Anterior Maxilla', 'Patients were randomly divided into 2 groups: patients in group I were', 'One hundred patients (50 per group; age range, 16 to 43\xa0yr), predominantly men']","['single infraorbital nerve block', 'anesthetic techniques (local infiltration vs infraorbital nerve block', 'anesthetized labially by local infiltration injections']","['Collateral anesthesia', 'Pain Reduction', 'Pain', 'numbness of the upper lip', 'rapid onset of anesthesia']","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0394792', 'cui_str': 'Local anesthetic infraorbital nerve block (procedure)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0458582', 'cui_str': 'Upper lip structure (body structure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}]",100.0,0.0361127,The results showed rapid onset of anesthesia in group II with a highly significant difference from group I (P ≤ .05).,"[{'ForeName': 'Firas A', 'Initials': 'FA', 'LastName': 'Jamil', 'Affiliation': 'Assistant Lecturer, Department of Oral and Maxillofacial Surgery, Dental Teaching Hospital, College of Dentistry, University of Baghdad, Baghdad, Iraq. Electronic address: cbf_rm@yahoo.com.'}, {'ForeName': 'Huda Moutaz', 'Initials': 'HM', 'LastName': 'Asmael', 'Affiliation': 'Assistant Lecturer, Department of Oral and Maxillofacial Surgery, Dental Teaching Hospital, College of Dentistry, University of Baghdad, Baghdad, Iraq.'}, {'ForeName': 'Ali Mohammed', 'Initials': 'AM', 'LastName': 'Hasan', 'Affiliation': 'Assistant Lecturer, Department of Oral and Maxillofacial Surgery, Dental Teaching Hospital, College of Dentistry, University of Baghdad, Baghdad, Iraq.'}, {'ForeName': 'Mohammed G', 'Initials': 'MG', 'LastName': 'Rzoqi', 'Affiliation': 'Assistant Lecturer, Department of Pedodontics and Preventive Dentistry, Dental Teaching Hospital, College of Dentistry, University of Baghdad, Baghdad, Iraq.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2018.09.029'] 594,32402554,"Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study).","PURPOSE Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial. DESIGN Multicenter cohort study. PARTICIPANTS Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion). METHODS Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit. MAIN OUTCOME MEASURES Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST). RESULTS Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0-12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3-14.5) better than baseline but 4.8 letters (95% CI, 2.5-7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4-5.0) better than baseline but 4.6 letters (95% CI, 3.1-6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142-166) and was stable between 2 and 5 years (-1 μm; 95% CI, -12 to 9). CONCLUSIONS Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.",2020,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","['Participants', 'Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion', 'for center-involved diabetic macular edema (CI-DME', 'eyes with DME']","['anti-VEGF therapy', 'aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment', 'Aflibercept, Bevacizumab, or Ranibizumab']","['Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST', '5-year visit, mean VA', '5-year visit', 'mean 5-year VA', 'Mean CST', 'mean retinal thickness', 'mean VA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]",,0.306087,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wells', 'Affiliation': 'Palmetto Retina Center, Columbia, South Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Josic', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, North Carolina.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Elman', 'Affiliation': 'Elman Retina Group, Pikesville, Maryland.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.021'] 595,32402558,Modified Sensory Stimulation Using Breastmilk for Reducing Pain Intensity in Neonates in Indonesia: A Randomized Controlled Trial.,"PURPOSE Several studies have shown that oral sucrose reduces pain in newborns. However, sucrose has no efficacy in eliminating pain and long-term effects remain unclear. Breast milk may be useful as an alternative, safe sweet solution. Sensorial saturation (SS) is a multisensory analgesic non-pharmacological treatment, which includes touch and sounds as distractors. This study aimed to compare the analgesic effects of SS with sucrose (SSS), SS with breast milk (SSB), and oral sucrose alone (S24%) in neonates undergoing venipuncture. DESIGN AND METHODS This was a randomized controlled trial conducted on 108 neonates who underwent venipuncture at neonatology wards. All babies were randomly assigned to one of three groups: two intervention groups and one control group. Pain response was assessed using the premature infant pain profile-revised (PIPP-R). Data analysis was conducted using the Kruskal-Wallis test and Mann-Whitney U test. RESULTS SSB and SSS were more effective than S24% (p = 0.001). No difference was observed between SSB and SSS (p = 0.669). CONCLUSION Multisensory stimulation is more effective in reducing pain than unimodal (oral sucrose) analgesia. Breast milk can be used as a sensory gustatory stimulus in multisensory stimulation to reduce pain intensity in neonates, and demonstrates a similar analgesic effect to sucrose. PRACTICE IMPLICATIONS The study findings suggest that neonatal nurses could use SSB for management of pain. This intervention could serve as an effective, inexpensive, and safe non-pharmacological analgesic. Additional testing of this intervention is warranted to support its use as an evidence-based pain reduction approach.",2020,"RESULTS SSB and SSS were more effective than S24% (p = 0.001).","['108 neonates who underwent venipuncture at neonatology wards', 'newborns', 'neonates in Indonesia', 'neonates undergoing venipuncture']","['Modified sensory stimulation', 'Multisensory stimulation', 'SS with sucrose (SSS), SS with breast milk (SSB), and oral sucrose alone (S24', 'Sensorial saturation (SS']","['pain intensity', 'Pain response', 'premature infant pain profile-revised (PIPP-R', 'pain', 'SSB and SSS']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0027621', 'cui_str': 'Neonatology'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]",108.0,0.149747,"RESULTS SSB and SSS were more effective than S24% (p = 0.001).","[{'ForeName': 'Siti Yuyun Rahayu', 'Initials': 'SYR', 'LastName': 'Fitri', 'Affiliation': 'Pediatric nursing department, Faculty of nursing, Universitas Padjadjaran, Bandung, Indonesia. Electronic address: siti.yuyun@unpad.ac.id.'}, {'ForeName': 'Lely', 'Initials': 'L', 'LastName': 'Lusmilasari', 'Affiliation': 'Pediatric and maternity nursing department, Faculty of medicine, public health and nursing, Universitas Gadjah Mada, Indonesia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Juffrie', 'Affiliation': 'Pediatric department, Faculty of medicine, public health and nursing, Universitas Gadjah Mada, Indonesia.'}, {'ForeName': 'Carlo Valerio', 'Initials': 'CV', 'LastName': 'Bellieni', 'Affiliation': 'Neonatal Intensive Care Unit, Siena University Hospital, Italy.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.04.004'] 596,29917096,Craving to Quit: A Randomized Controlled Trial of Smartphone App-Based Mindfulness Training for Smoking Cessation.,"INTRODUCTION Mindfulness training may reduce smoking rates and lessen the association between craving and smoking. This trial tested the efficacy of mindfulness training via smartphone app to reduce smoking. Experience sampling (ES) was used to measure real-time craving, smoking, and mindfulness. METHODS A researcher-blind, parallel randomized controlled trial compared the efficacy of mobile mindfulness training with experience sampling (MMT-ES; Craving to Quit) versus experience sampling only (ES) to (1) increase 1-week point-prevalence abstinence rates at 6 months, and (2) lessen the association between craving and smoking. A modified intent-to-treat approach was used for treatment starters (MMT-ES n = 143; ES n = 182; 72% female, 81% white, age 41 ± 12 year). RESULTS No group difference was found in smoking abstinence at 6 months (overall, 11.1%; MMT-ES, 9.8%; ES, 12.1%; χ2(1) = 0.43, p = .51). From baseline to 6 months, both groups showed a reduction in cigarettes per day (p < .0001), craving strength (p < .0001) and frequency (p < .0001), and an increase in mindfulness (p < .05). Using ES data, a craving by group interaction was observed (F(1,3785) = 3.71, p = .05) driven by a stronger positive association between craving and cigarettes per day for ES (t = 4.96, p < .0001) versus MMT-ES (t = 2.03, p = .04). Within MMT-ES, the relationship between craving and cigarettes per day decreased as treatment completion increased (F(1,104) = 4.44, p = .04). CONCLUSIONS Although mindfulness training via smartphone app did not lead to reduced smoking rates compared with control, our findings provide preliminary evidence that mindfulness training via smartphone app may help lessen the association between craving and smoking, an effect that may be meaningful to support quitting in the longer term. IMPLICATIONS This is the first reported full-scale randomized controlled trial of any smartphone app for smoking cessation. Findings provide preliminary evidence that smartphone app-based MMT-ES may lessen the association between craving and smoking. TRIAL REGISTRATION Clinicaltrials.gov NCT02134509.",2020,"From baseline to 6 months, both groups showed a reduction in cigarettes per day (p<.0001), craving strength (p<.0001) and frequency (p<.0001), and an increase in mindfulness (p<.05).",[],"['Smartphone app-based Mindfulness Training', 'smartphone', 'mindfulness training via smartphone', 'mobile mindfulness training with experience sampling (MMT-ES; Craving to Quit) vs. experience sampling-only (ES', 'Introduction\n\n\nMindfulness training']","['smoking abstinence rates', 'smoking abstinence', 'craving strength', 'smoking rates', 'Craving to Quit', 'real time craving, smoking and mindfulness']",[],"[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279973', 'cui_str': 'Experience Sampling'}, {'cui': 'C0046370', 'cui_str': 'MMT'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439797', 'cui_str': 'Sampling only (qualifier value)'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",,0.0730411,"From baseline to 6 months, both groups showed a reduction in cigarettes per day (p<.0001), craving strength (p<.0001) and frequency (p<.0001), and an increase in mindfulness (p<.05).","[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Garrison', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Prasanta', 'Initials': 'P', 'LastName': 'Pal', 'Affiliation': 'Department of Medicine and Psychiatry, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Rahil', 'Initials': 'R', 'LastName': 'Rojiani', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Scheinost', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dallery', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL.'}, {'ForeName': 'Judson A', 'Initials': 'JA', 'LastName': 'Brewer', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty126'] 597,32208889,Comparison of periarticular multidrug infiltration and epidural catheter use in total knee arthroplasty: A prospective randomized controlled study.,"PURPOSE The purpose of this study was to assess the effectiveness of periarticular multidrug infiltration (PMDI) and compare it with that of epidural catheter use. METHODS Fifty-eight patients (58 joints) who underwent total knee arthroplasty were included in this single-center, prospective, parallel, randomized, controlled trial. Preoperatively, patients were randomly categorized into the PMDI and epidural catheter groups. We evaluated postoperative pain (visual analog scale (VAS) and narcotic consumption), functional outcomes (range of motion (ROM) of knee flexion, the day patients could perform the straight-leg raising (SLR) test, and day of starting cane use), and laboratory data (white blood cell (WBC) and C-reactive protein (CRP)). RESULTS There was no significant difference in the VAS score, ROM of knee flexion, the day patients could do SLR, and the day of starting cane use between the PMDI and epidural catheter groups. However, the PMDI group could perform SLR on a postoperative day (POD) 1 ( p < 0.05). WBC level on POD 1 was significantly higher in the PMDI group ( p < 0.05), whereas the CRP levels on POD 1 ( p < 0.01), 3 ( p < 0.01), and 5 ( p < 0.01) were significantly lower in the PMDI group than in the epidural catheter group. The frequency of side effects was not significantly different between the groups. CONCLUSION PMDI was as effective as epidural catheter use for pain control. A higher percentage of patients who underwent PMDI could perform SLR on POD 1; therefore, the functional recovery was earlier in the PMDI group than in the epidural catheter group. PMDI may suppress inflammation in the whole body because of steroids.",2020,"There was no significant difference in the VAS score, ROM of knee flexion, the day patients could do SLR, and the day of starting cane use between the PMDI and epidural catheter groups.","['Fifty-eight patients (58 joints) who underwent total knee arthroplasty', 'total knee arthroplasty']","['PMDI', 'periarticular multidrug infiltration and epidural catheter', 'periarticular multidrug infiltration (PMDI', 'epidural catheter use']","['WBC level on POD 1', 'postoperative pain (visual analog scale (VAS) and narcotic consumption), functional outcomes (range of motion (ROM) of knee flexion, the day patients could perform the straight-leg raising (SLR) test, and day of starting cane use), and laboratory data (white blood cell (WBC) and C-reactive protein (CRP', 'postoperative day (POD', 'frequency of side effects', 'VAS score, ROM of knee flexion', 'CRP levels on POD 1', 'functional recovery']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter, device (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0006856', 'cui_str': 'Walking Sticks'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",58.0,0.0425194,"There was no significant difference in the VAS score, ROM of knee flexion, the day patients could do SLR, and the day of starting cane use between the PMDI and epidural catheter groups.","[{'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Ukai', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, Isehara, Kanagawa, Japan.'}, {'ForeName': 'Hamahashi', 'Initials': 'H', 'LastName': 'Kosuke', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, Isehara, Kanagawa, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Ebihara', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, Isehara, Kanagawa, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine, Isehara, Kanagawa, Japan.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020910663'] 598,31414245,CaringGuidance™ after breast cancer diagnosis eHealth psychoeducational intervention to reduce early post-diagnosis distress.,"PURPOSE Significant cancer-related distress affects 30-60% of women diagnosed with breast cancer. Fewer than 30% of distressed patients receive psychosocial care. Unaddressed distress is associated with poor treatment adherence, reduced quality of life, and increased healthcare costs. This study aimed to evaluate the preliminary efficacy of a new web-based, psychoeducational distress self-management program, CaringGuidance™ After Breast Cancer Diagnosis, on newly diagnosed women's reported distress. METHODS One-hundred women, in five states, diagnosed with breast cancer within the prior 3 months, were randomized to 12 weeks of independent use of CaringGuidance™ plus usual care or usual care alone. The primary multidimensional outcome, distress, was measured with the Distress Thermometer (DT), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Impact of Events Scale (IES) at baseline and months 1, 2, and 3. Intervention usage was continually monitored by the data analytic system imbedded within CaringGuidance™. RESULTS Although multilevel models showed no significant overall effects, post hoc analysis showed significant group differences in slopes occurring between study months 2 and 3 on distress (F(1,70) = 4.91, p = .03, η 2  = .065) measured by the DT, and depressive symptoms (F(1, 76) = 4.25, p = .043, η 2  = .053) favoring the intervention. CONCLUSIONS Results provide preliminary support for the potential efficacy of CaringGuidance™ plus usual care over usual care alone on distress in women newly diagnosed with breast cancer. This analysis supports and informs future study of this self-management program aimed at filling gaps in clinical distress management.",2020,"This study aimed to evaluate the preliminary efficacy of a new web-based, psychoeducational distress self-management program, CaringGuidance™","['women newly diagnosed with breast cancer', 'One-hundred women, in five states, diagnosed with breast cancer within the prior 3\xa0months', 'women diagnosed with breast cancer']","['CaringGuidance™ plus usual care or usual care alone', 'CaringGuidance™ after breast cancer diagnosis eHealth psychoeducational intervention', 'CaringGuidance', 'new web-based, psychoeducational distress self-management program, CaringGuidance™']","['quality of life, and increased healthcare costs', 'distress, was measured with the Distress Thermometer (DT), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Impact of Events Scale (IES', 'DT, and depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039818', 'cui_str': 'Thermometers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",100.0,0.0487959,"This study aimed to evaluate the preliminary efficacy of a new web-based, psychoeducational distress self-management program, CaringGuidance™","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Lally', 'Affiliation': 'University at Buffalo School of Nursing, Buffalo, NY, USA. robin.lally@unmc.edu.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'University of Nebraska Medical Center College of Nursing Biostatistician, 985330 Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Bellavia', 'Affiliation': 'Graduate School of Education, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hydeman', 'Affiliation': 'Department of Psychology, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'New York State Center of Excellence in Bioinformatics & Life Sciences, University at Buffalo Center for Computational Research, Buffalo, NY, USA.'}, {'ForeName': 'Vicki S', 'Initials': 'VS', 'LastName': 'Helgeson', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Erwin', 'Affiliation': 'Department of Oncology Health Disparity Research, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Mills', 'Affiliation': 'Nebraska Medicine, Department of Psychology, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Brown', 'Affiliation': 'School of Nursing, University at Buffalo, Buffalo, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05028-0'] 599,32406371,Slow-oscillation activity is reduced and high frequency activity is elevated in older adults with insomnia.,"STUDY OBJECTIVES High frequency electroencephalographic (EEG) activity (>16 Hz activity) is often elevated during non-rapid eye movement (NREM) sleep among individuals with insomnia, in line with the hyperarousal theory of insomnia. Evidence regarding sleep depth marked by slow-wave activity (<4 Hz) is more mixed. Distinguishing subcomponents of slow-wave activity (slow-oscillation (<1 Hz) or delta activity (1-4 Hz)) may be critical in understanding these discrepancies, given that these oscillations have different neural generators and are functionally distinct. Here we tested the effects of insomnia diagnosis and insomnia treatment on NREM EEG in older adults, distinguishing slow-oscillation and delta power. METHODS In 93 older adults with insomnia and 71 good sleeper control participants (mean ages 68), effects of insomnia and cognitive behavioral therapy for insomnia (CBTI) (insomnia group only) on EEG spectral power were analyzed. Main effects and interactions with NREM period were assessed for the following frequency bands: slow-oscillation (0.5-1 Hz), delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), sigma (12-16Hz), and beta (16-32 Hz). RESULTS Slow-oscillation absolute and relative power were lower in the insomnia group compared with controls. There were no group differences in delta power. Insomnia was also associated with elevated 4-32 Hz absolute and relative power. After CBTI, absolute sigma and beta activity decreased. CONCLUSIONS Deficits in slow-wave activity in insomnia are specific to the slow-oscillation. Elevated high frequency activity is reduced for sigma and beta power following CBTI. These findings inform the pathophysiology of insomnia, including the mechanisms underlying CBTI in older adults.",2020,There were no group differences in delta power.,"['93 older adults with insomnia and 71 good sleeper control participants (mean ages 68), effects of insomnia and cognitive behavioral therapy for insomnia (CBTI) (insomnia group only) on EEG spectral power were analyzed', 'individuals with insomnia, in line with the hyperarousal theory of insomnia', 'older adults with insomnia', 'older adults']",['insomnia diagnosis and insomnia treatment'],"['delta power', 'Insomnia', 'absolute sigma and beta activity decreased', 'Slow-oscillation absolute and relative power']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",93.0,0.0414553,There were no group differences in delta power.,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Hogan', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gisela M', 'Initials': 'GM', 'LastName': 'Delgado', 'Affiliation': ""St. Luke's Warren Campus, Phillipsburg, New Jersey.""}, {'ForeName': 'Martica H', 'Initials': 'MH', 'LastName': 'Hall', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vishwajit L', 'Initials': 'VL', 'LastName': 'Nimgoankar', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Wilckens', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8568'] 600,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition. METHODS In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment. RESULTS All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06). CONCLUSIONS Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up. IMPACT The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up. The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06). ","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06). ","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8'] 601,32403118,Proof of mechanism and target engagement of glutamatergic drugs for the treatment of schizophrenia: RCTs of pomaglumetad and TS-134 on ketamine-induced psychotic symptoms and pharmacoBOLD in healthy volunteers.,"Glutamate neurotransmission is a prioritized target for antipsychotic drug development. Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134) were assessed in two Phase Ib proof of mechanism studies of comparable designs and using identical clinical assessments and pharmacoBOLD methodology. POMA was examined in a randomized controlled trial under double-blind conditions for 10-days at doses of 80 or 320 mg/d POMA versus placebo (1:1:1 ratio). The TS-134 trial was a randomized, single-blind, 6-day study of 20 or 60 mg/d TS-134 versus placebo (5:5:2 ratio). Primary outcomes were ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS). Both trials were conducted contemporaneously. 95 healthy volunteers were randomized to POMA and 63 to TS-134. High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d = -0.41; p = 0.04, d = -0.44, respectively), but neither POMA dose significantly suppressed ketamine-induced dACC pharmacoBOLD. In contrast, low-dose TS-134 led to moderate to large within and between group reductions in both BPRS positive symptoms (p = 0.02, d = -0.36; p = 0.008, d = -0.82, respectively) and dACC pharmacoBOLD (p = 0.004, d = -0.56; p = 0.079, d = -0.50, respectively) using pooled across-study placebo data. High-dose POMA exerted significant effects on clinical symptoms, but not on target engagement, suggesting a higher dose may yet be needed, while the low dose of TS-134 showed evidence of symptom reduction and target engagement. These results support further investigation of mGluR2/3 and other glutamate-targeted treatments for schizophrenia.",2020,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","['healthy volunteers', '95 healthy volunteers']","['POMA versus placebo', 'TS-134 versus placebo', 'Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134', 'ketamine']","['BPRS positive symptoms', 'dACC pharmacoBOLD', 'BPRS total symptoms', 'clinical symptoms', 'ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",95.0,0.504117,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ragy R', 'Initials': 'RR', 'LastName': 'Girgis', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Junghee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, NY, USA. Jeffrey.Lieberman@nyspi.columbia.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0706-z'] 602,30452705,Web-Based Contingency Management for Adolescent Tobacco Smokers: A Clinical Trial.,"INTRODUCTION Adolescence is a critical time when the majority of tobacco users initiate smoking. Contingency management for adolescent smoking cessation has shown promise in previous studies, but efficacy following removal of contingencies is not well understood. This study examined a remote form of contingency management among non-treatment-seeking adolescent smokers. METHODS Participants (N = 127) submitted breath carbon monoxide (CO) three times daily throughout a 42-day program. For this randomized trial, participants in the active condition (n = 63) were reinforced for providing CO measurements on schedule and below a set criterion, whereas those in the control condition (n = 64) were reinforced for providing CO measurements on schedule. Self-reported smoking and urinary cotinine levels were collected at several timepoints. RESULTS Active condition showed greater within-group reductions in CO levels relative to control condition, but not at 3- or 6-month follow-up. Active condition reported significantly less smoking during treatment compared to control condition, but not at follow-up. There were no significant differences for urinary cotinine. Overall treatment adherence was low, with only 37% and 51% of possible CO samples being submitted among active and control, respectively. Poor treatment adherence may explain the disparity between CO and cotinine results, and poor follow-up treatment efficacy. CONCLUSIONS This study replicates feasibility of a remote form of contingency management for adolescent smoking. CO results suggest active condition reduced smoking within group, but treatment adherence and posttreatment efficacy was poor. Future research should focus on increasing adherence for this type of program among adolescent smokers. IMPLICATIONS This study demonstrates feasibility of a remote form of contingency management therapy for smoking cessation among adolescents, while providing posttreatment efficacy data. Within-group efficacy of this form of treatment is suggested, but treatment adherence and follow-up efficacy were poor. This study underscores the need for further development of contingency management therapy for adolescent smoking cessation, which emphasizes better treatment adherence and posttreatment efficacy.",2020,"Overall treatment adherence was low, with only 37% and 51% of possible CO samples being submitted among active and control, respectively.","['participants in the active condition (n = 63', 'adolescent smoking', 'non-treatment seeking adolescent smokers', 'adolescent smokers', 'Adolescent Tobacco Smokers', 'adolescent smoking cessation']","['contingency management therapy', 'breath carbon monoxide (CO', 'Web-Based Contingency Management']","['Overall treatment adherence', 'urinary cotinine', 'Self-reported smoking and urinary cotinine levels', 'CO levels']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",63.0,0.0137398,"Overall treatment adherence was low, with only 37% and 51% of possible CO samples being submitted among active and control, respectively.","[{'ForeName': 'Arit', 'Initials': 'A', 'LastName': 'Harvanko', 'Affiliation': 'Center for Tobacco Research and Education, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Slone', 'Affiliation': 'Markey Cancer Center, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Shelton', 'Affiliation': 'Markey Cancer Center and Department of Biostatistics, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dallery', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL.'}, {'ForeName': 'Sherecce', 'Initials': 'S', 'LastName': 'Fields', 'Affiliation': 'Department of Psychology, Texas A&M University, College Station, TX.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Reynolds', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, Lexington, KY.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty243'] 603,30820567,"Concurrent Alcohol Use and Waterpipe Tobacco Smoking: Smoking Topography, Toxicant Exposure, and Abuse Liability.","INTRODUCTION Relative to non-waterpipe (WP) smokers, WP smokers are more than twice as likely to use alcohol and frequently consume alcohol before or during smoking sessions. Co-use of alcohol and WP may result in greater toxicant exposure compared to WP smoking alone. To date, no study systematically has investigated the impact of acute alcohol intoxication on WP smoking topography, exposure to tobacco-related toxicants, or abuse liability. METHODS Dyads of current WP smokers and drinkers (N = 42; age = 21-32 years) completed two in-laboratory ad libitum smoking sessions (≤2 hours) following 12-hour nicotine abstinence in a double-blind, randomized crossover design in which they consumed a placebo versus active drink (sustained breath alcohol concentration = .08). Exhaled carbon monoxide (eCO) and plasma nicotine concentration were assessed. Questionnaires assessed smoking experience and smoking urge. Smoking topography was measured continuously throughout each smoking session. RESULTS The alcohol session was associated with increased inhaled volume, flow rate, and WP session duration compared to placebo. Compared to placebo, participants reported a more positive overall smoking experience following the alcohol session and greater smoking urges pre- and post-smoking session. Although both sessions resulted in significant increases in eCO and plasma nicotine, no significant differences emerged in eCO or nicotine exposure between the active and placebo sessions. CONCLUSIONS Co-use of alcohol and WP may contribute to the maintenance of WP smoking through enhanced smoking experiences, increased urge to smoke, and significant exposure to addictive nicotine. Regulations may be necessary to limit the sale of alcohol in WP smoking lounges and reduce exposure to secondhand smoke. IMPLICATIONS The findings suggest co-use of alcohol and WP tobacco likely maintain WP use and dependence by enhancing the smoking experience and increasing urges to smoke. These findings have implications for regulations aimed at limiting co-use of alcohol and WP tobacco in WP lounges and limiting exposure to secondhand smoke. CLINICAL TRIALS REGISTRATION NCT03096860.",2020,"Compared to placebo, participants reported a more positive overall smoking experience following the alcohol session and greater smoking urges pre- and post-smoking session.",['Dyads of current WP smokers and drinkers (N=42; age=21-32 years) completed two in'],"['Concurrent alcohol use and waterpipe tobacco smoking', 'laboratory ad libitum smoking sessions (≤2-hours) following 12-hour nicotine abstinence', 'placebo']","['inhaled volume, flow rate, and WP session duration', 'Smoking topography, toxicant exposure, and abuse liability', 'eCO or nicotine exposure', 'eCO and plasma nicotine', 'Questionnaires assessed smoking experience and smoking urge', 'Exhaled carbon monoxide (eCO) and plasma nicotine concentration', 'positive overall smoking experience', 'Smoking topography']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C4505131', 'cui_str': 'Tobacco, Waterpipe'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0120395,"Compared to placebo, participants reported a more positive overall smoking experience following the alcohol session and greater smoking urges pre- and post-smoking session.","[{'ForeName': 'Eleanor L S', 'Initials': 'ELS', 'LastName': 'Leavens', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Morgan', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Emma I', 'Initials': 'EI', 'LastName': 'Brett', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Patzkowsky', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Son', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Molina', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Shihadeh', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Thad R', 'Initials': 'TR', 'LastName': 'Leffingwell', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK.'}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'Wagener', 'Affiliation': 'Oklahoma Tobacco Research Center, Oklahoma City, OK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz032'] 604,32191766,Effect of intraoperative Hartmann's versus hypotonic solution administration on FLACC pain scale scores in children: A prospective randomized controlled trial.,"BACKGROUND In healthy children, an isotonic solution containing no glucose or a small amount of glucose (1-2%) has been recommended as an intraoperative maintenance fluid due to the potential risk of hyponatremia associated with hypotonic solutions. However, a hypotonic solution with glucose is still widely used as a maintenance fluid for pediatric anesthesia. We speculated that the hypotonic solution may worsen postoperative discomfort and irritability in pediatric patients due to hyponatremia. PATIENTS AND METHODS In the current study, we compared the post-operative Face, Legs, Activity, Cry, Consolability(FLACC) scale scores of pediatric patients aged 3-10 years who received either a 1:2 dextrose solution or Hartmann's solution during Nuss Bar removal. RESULTS The FLACC scale score in the post-anesthesia care unit was higher in the 1:2 dextrose solution group(HYPO) (n = 20) than in the Hartmann's solution group(ISO) (n = 20) (6.30 vs 4.70, p = 0.044, mean difference and 95% Confidence Interval(CI) was 1.6 (0.04 to 3.16)). We also compared opioid consumption at the post-anesthesia care unit. Total dose of fentanyl per body weight in the post-anesthesia care unit was also higher in the HYPO (0.59 vs 0.37 mcg/kg, p = 0.042, mean difference and 95% CI was 0.22 mcg/kg (0.030 to 0.402)). CONCLUSIONS Intraoperative use of the hypotonic solution in children causes increased FLACC scale scores, leading to higher opioid consumption in post-anesthesia care unit.",2020,The FLACC scale score in the post-anesthesia care unit was higher in the 1:2 dextrose solution group(HYPO),"['pediatric patients aged 3-10 years who received either a 1:2', 'children', 'healthy children', 'pediatric patients due to hyponatremia']","['hypotonic solution', 'hypotonic solution administration', ""dextrose solution or Hartmann's solution"", 'dextrose solution group(HYPO', ""intraoperative Hartmann's"", 'isotonic solution containing no glucose']","['Total dose of fentanyl per body weight', 'postoperative discomfort and irritability', 'FLACC pain scale scores', 'post-operative Face, Legs, Activity, Cry, Consolability(FLACC) scale scores', 'FLACC scale score', 'FLACC scale scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]","[{'cui': 'C0020677', 'cui_str': 'Hypotonic Solutions'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}]",,0.274341,The FLACC scale score in the post-anesthesia care unit was higher in the 1:2 dextrose solution group(HYPO),"[{'ForeName': 'Mihyun', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Minsoo', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Min Suk', 'Initials': 'MS', 'LastName': 'Chae', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hyungmook', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",PloS one,['10.1371/journal.pone.0230556'] 605,30829067,Reducing Coronary Heart Disease Risk Through Treatment of Insomnia Using Web-Based Cognitive Behavioral Therapy for Insomnia: A Methodological Approach.,"Objective : Observational data demonstrate increased risk of recurrent acute coronary syndrome in patients with comorbid insomnia. We conducted a pragmatic randomized controlled pilot study to address knowledge gaps and inform future large-scale randomized trials to test the impact of Web-based cognitive behavioral therapy for insomnia (wCBT-I) on coronary heart disease (CHD) outcomes. Participants : Thirty-five adults recruited from Brigham and Women's and Cleveland Clinic Hospitals with insomnia, defined by Insomnia Severity Index (ISI) score ≥ 10 and symptoms of at least 3 months, and comorbid CHD identified from medical records. Methods : We randomized 34 patients to either general sleep education coupled with wCBT-I or general sleep education alone followed by an opportunity for treatment after the study (a wait-list control) to evaluate feasibility and uptake of insomnia treatment in patients with heart disease. Participants completed the ISI at baseline and 6 weeks to assess insomnia severity. Results : Twenty-nine adults completed the trial, yielding an 85% retention rate, and adherence rate in the treatment arm was 80%. Mean age was 71.6 ± 9.5 years, 75% were male, and mean body mass index (BMI) was 29 ± 4.5 kg/m 2 . Baseline ISI scores were 15.6. There was a 6.2 ± 5.3 point reduction in ISI scores in the intervention arm and a 3.3 ± 5.1 reduction in the control arm ( p value 0.1). Conclusion : Web-based CBT-I intervention was feasible in an older sample with prevalent CHD and resulted in clinically meaningful improvement in insomnia severity, though statistical significance was limited by lack of power.",2020,"CONCLUSION Web-based CBT-I intervention was feasible in an older sample with prevalent CHD and resulted in clinically meaningful improvement in insomnia severity, though statistical significance was limited by lack of power.","[""Thirty-five adults recruited from Brigham and Women's and Cleveland Clinic Hospitals with insomnia, defined by Insomnia Severity Index (ISI) score ≥\xa010 and symptoms of at least 3\xa0months, and comorbid CHD identified from medical records"", 'patients with heart disease', 'patients with comorbid insomnia', 'Mean age was 71.6\xa0±\xa09.5\xa0years, 75% were male, and mean body mass index (BMI) was 29\xa0±\xa04.5 kg/m 2 ', 'Twenty-nine adults', '34 patients to either general sleep education coupled with', 'Insomnia']","['wCBT-I or general sleep education alone followed by an opportunity for treatment after the study (a wait-list control', 'Insomnia Using Web-Based Cognitive Behavioral Therapy', 'Web-based cognitive behavioral therapy']","['retention rate, and adherence rate', 'Baseline ISI scores', 'ISI scores', 'insomnia severity']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454845', 'cui_str': 'Cleveland (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4706228', 'cui_str': 'Insomnia Severity Index score (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",34.0,0.118758,"CONCLUSION Web-based CBT-I intervention was feasible in an older sample with prevalent CHD and resulted in clinically meaningful improvement in insomnia severity, though statistical significance was limited by lack of power.","[{'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': ""Brigham and Women's Hospital, Boston and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""Brigham and Women's Hospital, Boston and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Cleveland Clinic Sleep Disorders Center, Cleveland, OH.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Cleveland Clinic Sleep Disorders Center, Cleveland, OH.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Brigham and Women's Hospital, Boston and Harvard Medical School, Boston, MA.""}]",Behavioral sleep medicine,['10.1080/15402002.2019.1584896'] 606,31006271,Self-Reported Sleep Quality and Actigraphic Measures of Sleep in New Mothers and the Relationship to Postpartum Depressive Symptoms.,"Objective : This study's purpose is to examine relationships between self-reported sleep quality, actigraphy data, and depressive symptoms in a sample of women at 6 and 12 weeks postpartum. Methods : This secondary analysis of data from a randomized controlled trial (RCT) of a behavioral sleep intervention measured sleep with actigraphy and self-report. Self-reported measures included the General Sleep Disturbance Scale (GSDS) and mothers' reports of their sleep as a ""small/big/no"" problem. Depression was measured with the Edinburgh Postnatal Depression Scale (EPDS). Control variables included group allocation, baseline EPDS, and social support. Logistic regression estimated the association between self-reported and actigraphic measures of sleep and the presence of postpartum depressive symptoms. Separate models estimated the odds of depression according to each sleep variable. Results : In 217 first-time mothers, GSDS scores in the last week of pregnancy were not related to depression; however, GSDS scores at 6 weeks postpartum were associated with > 3 times the odds of depressive symptoms (OR = 3.56; 95% CI = 1.73-7.33) at either 6 or 12 weeks postpartum. The perception that sleep was a ""small"" or ""big"" problem at 6 weeks was associated with > 3 (OR = 3.40; 95% CI = 1.54-7.46) and > 8 (OR = 8.29; 95% CI = 2.41-28.59) times the odds of depressive symptoms at either 6 or 12 weeks, respectively. Significant associations between actigraphic sleep measures and depressive symptoms were not found. Conclusion : Self-reported sleep quality is strongly associated with postpartum depressive symptoms. Sleep concerns may be an important clinical indicator of low mood in the postpartum period. Future intervention studies to improve mood could target sleep concerns via cognitive-behavioral strategies.",2020,"In 217 first-time mothers, GSDS scores in the last week of pregnancy were not related to depression; however, GSDS scores at 6 weeks postpartum were associated with > 3 times the odds of depressive symptoms (OR = 3.56; 95% CI = 1.73-7.33) at either 6 or 12 weeks postpartum.",['a sample of women at 6 and 12\xa0weeks postpartum'],['behavioral sleep intervention'],"['Depression', 'depressive symptoms', 'sleep quality, actigraphy data, and depressive symptoms', 'Self-Reported Sleep Quality and Actigraphic Measures of Sleep', 'General Sleep Disturbance Scale (GSDS', 'actigraphic sleep measures and depressive symptoms', 'baseline EPDS, and social support', 'sleep quality', 'Edinburgh Postnatal Depression Scale (EPDS', 'GSDS scores']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0222045'}, {'cui': 'C0037438'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0706302,"In 217 first-time mothers, GSDS scores in the last week of pregnancy were not related to depression; however, GSDS scores at 6 weeks postpartum were associated with > 3 times the odds of depressive symptoms (OR = 3.56; 95% CI = 1.73-7.33) at either 6 or 12 weeks postpartum.","[{'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Stremler', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'McMurray', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brennenstuhl', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1601629'] 607,32402504,"Response to Letter Regarding ""A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis"".",,2020,,['Patients With Knee Osteoarthritis'],['Low-Dose Extracorporeal Shockwave Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]",[],,0.046562,,"[{'ForeName': 'Zongye', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bangzhong', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Deparment of Radiology, Huashan Hospital, Fudan University, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.008'] 608,32402732,Transversus abdominis plane block with liposomal bupivacaine and its effect on opiate use after weight loss surgery: a randomized controlled trial.,"BACKGROUND Liposomal bupivacaine (LB), as an extended-release local anesthetic, may provide lasting pain control and therefore decrease the need for narcotics in the immediate postoperative period. OBJECTIVES The aim of this study was to evaluate whether transversus abdominis plane (TAP) block with LB decreased the use of postoperative narcotics compared with regular bupivacaine (RB) and no TAP block in patients undergoing weight loss procedures. SETTING A large, metropolitan, university-affiliated, tertiary hospital. METHODS Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year were randomized to receive TAP block using LB, TAP block with RB, or no block in a double-blind, randomized controlled trial. The outcomes measured were postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea. Data were analyzed using χ 2 test and analysis of variance F test. RESULTS Two hundred nineteen patients were included in the study. Fentanyl patient-controlled analgesia usage was not significantly different between the groups (LB 351.4 versus RB 360.7 versus no TAP block 353.9, P = .97) at 48 hours post operation. The pain scores (scale 1-10) were similar among the groups with the mean for the LB group at 4.3, and RB and no TAP block groups both at 4.7 (P = .35). The type of block or lack of block did not significantly impact the length of stay, time to ambulation, or presence of nausea. CONCLUSION The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.",2020,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"['A large, metropolitan, university-affiliated, tertiary hospital', 'opiate use after weight loss surgery', 'patients undergoing weight loss procedures', 'Two hundred nineteen patients were included in the study', 'Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year']","['transversus abdominis plane (TAP) block with LB', 'regular bupivacaine (RB) and no TAP block', 'Liposomal bupivacaine (LB', 'TAP block using LB, TAP block with RB, or no block', 'liposomal bupivacaine']","['Fentanyl patient-controlled analgesia usage', 'pain scores', 'length of stay, time to ambulation, or presence of nausea', 'postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea', 'total opiate pain medication consumption']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",219.0,0.208823,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"[{'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Ana Garcia', 'Initials': 'AG', 'LastName': 'Cabrera', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Argiroff', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pechman', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York; Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Vazzana', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Moran-Atkin', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jenny J', 'Initials': 'JJ', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Diego R', 'Initials': 'DR', 'LastName': 'Camacho', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York. Electronic address: Dicamach@montefiore.org.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.03.031'] 609,32405884,Effect of patient-specific instrument on lowering threshold for junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients.,"PURPOSE To create a patient-specific instrument (PSI) in lowering the surgical experience requirement for junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients. METHODS Combined with rapid prototyping technology, we created a PSI and established DDH hip model in vitro. We enrolled 48 junior physicians and randomly assigned them into two groups. After creation of the PSI, they performed simulated THA surgery on a full-scale hip model with or without PSI on DDH models. The planned prothesis orientation, post-operative prothesis orientation, and surgery time were recorded. RESULTS The final cup inclination was 42.0 ± 0.8° in PSI group and 37.8 ± 2.0° in control group, while final cup anteversion was 16.0 ± 0.7° in PSI group and 24.7 ± 3.5° in control group. The △inclination in PSI group was smaller than that in control group (4.2 ± 0.5° vs 9.5 ± 1.4°, P < 0.01), so does △inclination (2.9 ± 0.4° in PSI group vs 15.2 ± 2.5° in control group, P < 0.01). The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01). At the same time, the PSI group did not prolong the operation time (P = 0.551). CONCLUSION The PSI can greatly increase the accuracy of placing the cup orientation and lower the threshold for junior physicians to perform THA on DDH patients. It could be a training tool for them to increase their THA surgical skills.",2020,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"['junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients', '48 junior physicians', 'junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients']","['patient-specific instrument (PSI', 'patient-specific instrument', 'rapid prototyping technology']",['operation time'],"[{'cui': 'C0524635', 'cui_str': 'Physicians, Junior'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",48.0,0.0184023,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Sports Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chenggong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China. Dr_zhongda@126.com.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yihe', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shilong', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",International orthopaedics,['10.1007/s00264-020-04599-6'] 610,32160260,Effect of informatization-based blood glucose team management on the control of hyperglycaemia in noncritical care units.,"PURPOSE To provide a new system of in-hospital blood glucose team management combined with a network blood glucose monitoring system and analyse the effect on hyperglycaemic participants' blood glucose control in noncritical care units. METHODS Hyperglycaemic participants in noncritical care units were divided into two groups. They underwent active intervention by the hospital's blood glucose management team or the routine consultation group. The better method, based on a shorter length of stay (LOS) and lower hospital cost, could be selected by comparing the two blood glucose management strategies. RESULTS Compared with the routine consultation group, the team management group had a higher detection rate of hyperglycaemia (18.49% vs 16.17%, P<0.01) and glycosylated haemoglobin (51.53% vs 30.97%, P<0.01) and a lower incidence rate of hyperglycaemia (59.24% vs 61.59%, P<0.01), severe hyperglycaemia (3.56% vs 5.19%, P<0.01) and clinically significant hypoglycaemia (0.26% vs 0.35%, P<0.05). Simultaneously, blood glucose drift (mmol/L) (2.50 (1.83, 3.25) vs 2.76 (2.01, 3.57), P<0.01), blood glucose coefficient of variation (%) (28.86 (22.70, 34.83) vs 29.80 (23.47, 36.13), P<0.01), maximum blood glucose fluctuation (mmol/L) (9.30 (6.20, 13.10) vs 10.10 (7.00, 14.40), P<0.01) and nosocomial infection (5.42% vs 8.05%, P<0.05) were all lower among participants in the team management group. In addition, the LOS (P<0.001) and hospital costs (P<0.001) of participants were lower in the team management group. CONCLUSION In-hospital blood glucose team management combined with a network blood glucose monitoring system effectively improved the blood glucose control and fluctuation levels of participants who were admitted to noncritical care units, thereby reducing LOS and hospital cost.",2020,"In addition, the LOS (P<0.001) and hospital costs (P<0.001) of participants were lower in the team management group. ","['hyperglycaemia in noncritical care units', 'Hyperglycaemic participants in noncritical care units', 'participants who were admitted to noncritical care units', ""hyperglycaemic participants' blood glucose control in noncritical care units""]","[""active intervention by the hospital's blood glucose management team or the routine consultation group"", 'informatization-based blood glucose team management', 'network blood glucose monitoring system']","['blood glucose drift (mmol/L', 'severe hyperglycaemia', 'nosocomial infection', 'hospital costs', 'blood glucose control and fluctuation levels', 'detection rate of hyperglycaemia', 'shorter length of stay (LOS) and lower hospital cost', 'glycosylated haemoglobin', 'blood glucose coefficient of variation', 'incidence rate of hyperglycaemia', 'clinically significant hypoglycaemia', 'maximum blood glucose fluctuation']","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1638311', 'cui_str': 'Blood sugar management (procedure)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205721', 'cui_str': 'Infections, Hospital'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0877314', 'cui_str': 'Blood glucose fluctuation'}]",,0.0244574,"In addition, the LOS (P<0.001) and hospital costs (P<0.001) of participants were lower in the team management group. ","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xian-Jun', 'Initials': 'XJ', 'LastName': 'Zhu', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Nie', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Peng-Qiu', 'Initials': 'PQ', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}]",PloS one,['10.1371/journal.pone.0230115'] 611,30570315,A mind full of happiness: How mindfulness shapes affect dynamics in daily life.,"Mindfulness plays an important role in moderating affect dynamics. To date, associations between mindfulness and affect dynamics have mostly been examined with mindfulness as a trait-like characteristic. However, examining associations between momentary mindfulness and affect dynamics could reveal important within-person processes underlying mindfulness and wellbeing. The present study first examined dispositional mindfulness as a 1-dimensional as well as a multifaceted construct in relation to affect dynamics (instability, inertia, and valence switch). We further investigated how momentary mindfulness predicts affect dynamics, and how training momentary mindfulness with a mindfulness training influences affect dynamics in daily life. A final sample of 125 undergraduate students took part in a 6-week randomized controlled trial, either engaging in a low-intensity mindfulness training ( n = 61) or being part of a wait-list control condition ( n = 64). We assessed participants' low and high arousal positive (PA) and negative affect (NA) and their momentary mindfulness 6 times a day for 40 consecutive days by implementing an ambulatory assessment (AA) protocol during either the mindfulness training or waiting period, respectively. We found that the dispositional mindfulness facet present-awareness was negatively associated with low arousal NA inertia and a lower switching propensity. However, we found momentary mindfulness to be positively associated with low arousal PA inertia, a lower switching propensity to NA and less instability. Furthermore, participants who practiced mindfulness experienced reduced low arousal NA inertia. These findings demonstrate that momentary mindfulness may be helpful in promoting adaptive affect experiences and maintaining PA, which could ultimately foster affective well-being. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"However, we found momentary mindfulness to be positively associated with low arousal PA inertia, a lower switching propensity to NA and less instability.",['125 undergraduate students'],['engaging in a low-intensity mindfulness training ( n = 61) or being part of a wait-list control condition'],"[""participants' low and high arousal positive (PA) and negative affect (NA"", 'low arousal PA inertia', 'low arousal NA inertia']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",125.0,0.0138665,"However, we found momentary mindfulness to be positively associated with low arousal PA inertia, a lower switching propensity to NA and less instability.","[{'ForeName': 'Zarah', 'Initials': 'Z', 'LastName': 'Rowland', 'Affiliation': 'Institute of Psychology.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Psychology.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kubiak', 'Affiliation': 'Institute of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000562'] 612,32201198,Levosimendan Versus Milrinone for Inotropic Support in Pediatric Cardiac Surgery: Results From a Randomized Trial.,"OBJECTIVE The present study aimed to determine the differential effects of intraoperative administration of milrinone versus levosimendan on myocardial function after pediatric cardiac surgery. Transthoracic echocardiography was used for myocardial function evaluation using biventricular longitudinal strain with 2-dimensional speckle tracking echocardiography in addition to conventional echocardiographic variables. DESIGN A secondary analysis of a randomized, prospective, double-blinded clinical drug trial. SETTING Two pediatric tertiary university hospitals. PARTICIPANTS Infants between 1 and 12 months old diagnosed with ventricular septal defect, complete atrioventricular septal defect, or tetralogy of Fallot who were scheduled for corrective surgery with cardiopulmonary bypass. INTERVENTIONS The patients were randomly assigned to receive an infusion of milrinone or levosimendan at the start of cardiopulmonary bypass and for 26 consecutive hours. MEASUREMENTS AND MAIN RESULTS Biventricular longitudinal strain and conventional echocardiographic variables were measured preoperatively, on the first postoperative morning, and before hospital discharge. The association between perioperative parameters and postoperative myocardial function also was investigated. Images were analyzed for left ventricular (n = 67) and right ventricular (n = 44) function. The day after surgery, left ventricular longitudinal strain deteriorated in both the milrinone and levosimendan groups (33% and 39%, respectively). The difference was not significant. The corresponding deterioration in right ventricular longitudinal strain was 42% and 50% (nonsignificant difference). For both groups, biventricular longitudinal strain approached preoperative values at hospital discharge. Preoperative N-terminal pro-brain natriuretic peptide could predict the left ventricular strain on postoperative day 1 (p = 0.014). CONCLUSIONS Levosimendan was comparable with milrinone for left and right ventricular inotropic support in pediatric cardiac surgery.",2020,"The day after surgery, left ventricular longitudinal strain deteriorated in both the milrinone and levosimendan groups (33% and 39%, respectively).","['Pediatric Cardiac Surgery', 'after pediatric cardiac surgery', 'Infants between 1 and 12 months old diagnosed with ventricular septal defect, complete atrioventricular septal defect, or tetralogy of Fallot who were scheduled for corrective surgery with cardiopulmonary bypass', 'Two pediatric tertiary university hospitals', 'pediatric cardiac surgery']","['milrinone', '2-dimensional speckle tracking echocardiography', 'Levosimendan', 'levosimendan', 'milrinone or levosimendan', 'milrinone and levosimendan', 'Levosimendan Versus Milrinone', 'Transthoracic echocardiography']","['myocardial function', 'corresponding deterioration in right ventricular longitudinal strain', 'left ventricular longitudinal strain deteriorated', 'Biventricular longitudinal strain and conventional echocardiographic variables']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0018818', 'cui_str': 'Intraventricular Septal Defects'}, {'cui': 'C0344787', 'cui_str': 'Atrioventricular septal defect: atrial and ventricular components (disorder)'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0439691', 'cui_str': 'Speckled (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.159698,"The day after surgery, left ventricular longitudinal strain deteriorated in both the milrinone and levosimendan groups (33% and 39%, respectively).","[{'ForeName': 'Elin M', 'Initials': 'EM', 'LastName': 'Thorlacius', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: elin.thorlacius@gu.se.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Wåhlander', 'Affiliation': 'Department of Pediatric Cardiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Ojala', 'Affiliation': ""Department of Pediatric Cardiology, Children's Hospital, Helsinki University Hospital, Helsinki University, Helsinki, Finland.""}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Ylänen', 'Affiliation': ""Department of Pediatric Cardiology, Children's Hospital, Helsinki University Hospital, Helsinki University, Helsinki, Finland.""}, {'ForeName': 'Juho', 'Initials': 'J', 'LastName': 'Keski-Nisula', 'Affiliation': ""Department of Anesthesia and Intensive Care, Children's Hospital, Helsinki University Hospital, Helsinki University, Helsinki, Finland.""}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Synnergren', 'Affiliation': 'Department of Pediatric Thoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Birgitta S', 'Initials': 'BS', 'LastName': 'Romlin', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Castellheim', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.02.027'] 613,32402609,Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study.,"Cranial electrical stimulation (CES) is a noninvasive brain stimulation technique that has been shown to improve pain. However, few studies have investigated the potential benefits associated with remotely supervised CES in older adults with knee osteoarthritis (OA). The aim of this study was to examine the feasibility and preliminary efficacy of remotely supervised CES via secure videoconferencing software on clinical pain severity, experimental pain sensitivity, and pain-related cortical response in older adults with knee OA. Thirty participants with symptomatic knee OA pain were randomly assigned to receive 10 daily sessions (60 min each) of remotely supervised CES (n = 15) or sham CES (n = 15) over two weeks. We measured clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging. We also measured participant satisfaction with treatment using the Client Satisfaction Questionnaire. Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation. We also found significant changes in pain-related cortical hemodynamic activity after CES. Participants tolerated CES well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising clinical efficacy of remotely supervised CES for older adults with knee OA.",2020,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","['older adults with knee osteoarthritis (OA', 'older adults with knee OA', 'older adults with knee osteoarthritis', 'Thirty participants with symptomatic knee OA pain']","['Cranial electrical stimulation (CES', 'Active CES', 'remotely supervised CES (n\xa0=\xa015) or sham CES', 'remotely supervised CES via secure videoconferencing software', 'remotely supervised CES', 'remotely supervised cranial electrical stimulation']","['clinical pain severity, experimental pain sensitivity, and pain-related cortical response', 'pain-related cortical hemodynamic activity', 'Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation', 'clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging', 'Participants tolerated CES well without serious adverse effects', 'Feasibility and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.10685,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","[{'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Hyochol.Ahn@uth.tmc.edu.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Galle', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Mathis', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montero-Hernandez', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hsiao-Hui', 'Initials': 'HH', 'LastName': 'Ju', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCrackin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hargraves', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Jain', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dinh', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Abdul-Mooti', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pollonini', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.05.003'] 614,32051005,"My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial.","BACKGROUND Multimorbidity affects four of ten US adults and eight of ten adults ages 65 years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns. Hispanics/Latinos (hereafter, Latinos) and other ethnic minorities are more vulnerable to these conditions, and face structural, social, and cultural barriers to obtaining quality physical and behavioral healthcare. We report the protocol for a randomized controlled trial that will compare Mi Puente (My Bridge), a cost-efficient care transitions intervention conducted by a specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches, in reducing hospital utilization and improving patient reported outcomes in Latino adults with multiple cardiometabolic conditions and behavioral health concerns. The study will examine the degree to which Mi Puente produces superior reductions in hospital utilization at 30 and 180 days (primary aim) and better patient-reported outcomes (quality of life/physical health; barriers to healthcare; engagement with outpatient care; patient activation; resources for chronic disease management), and will examine the cost effectiveness of the Mi Puente intervention relative to usual care. METHODS Participants are enrolled as inpatients at a South San Diego safety net hospital, using information from electronic medical records and in-person screenings. After providing written informed consent and completing self-report assessments, participants randomized to usual care receive best-practice discharge processes, which include educational materials, assistance with outpatient appointments, referrals to community-based providers, and other assistance (e.g., with billing, insurance) as required. Those randomized to Mi Puente receive usual-care materials and processes, along with inpatient visits and up to 4 weeks of follow-up phone calls from the intervention team to address their integrated physical-behavioral health needs and support the transition to outpatient care. DISCUSSION The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns. If shown to be effective, close linkages with outpatient healthcare and community organizations will help maximize uptake, dissemination, and scaling of the Mi Puente intervention. TRIAL REGISTRATION ClinicalTrials.gov: NCT02723019. Registered on 30 March 2016.",2020,The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns.,"['Hispanics/Latinos with multimorbidity and behavioral health concerns', 'ten US adults and eight of ten adults ages 65\u2009years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns', 'Participants are enrolled as inpatients at a South San Diego safety net hospital, using information from electronic medical records and in-person screenings', 'Latino adults with multiple cardiometabolic conditions and behavioral health concerns']","['Mi Puente (My Bridge', 'specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches', 'My Bridge (Mi Puente', 'usual care receive best-practice discharge processes, which include educational materials, assistance with outpatient appointments, referrals to community-based providers, and other assistance (e.g., with billing, insurance']",[],"[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]",[],,0.0592154,The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns.,"[{'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Gallo', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego CA, USA. lgallo@sdsu.edu.'}, {'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, La Jolla CA, USA.'}, {'ForeName': 'Julia I', 'Initials': 'JI', 'LastName': 'Bravin', 'Affiliation': 'Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Clark', 'Affiliation': 'Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Savin', 'Affiliation': 'Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Duvia Lara', 'Initials': 'DL', 'LastName': 'Ledesma', 'Affiliation': 'San Diego State University Research Foundation, San Diego CA, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Euyoque', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, La Jolla CA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, La Jolla CA, USA.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Roesch', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego CA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gilmer', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Talavera', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego CA, USA.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, La Jolla CA, USA.'}]",Trials,['10.1186/s13063-019-3722-8'] 615,32061400,"Preoperative, single, high-dose glucocorticoid administration in abdominal wall reconstruction: A randomized, double-blinded clinical trial.","BACKGROUND Although preoperative administration of high-dose glucocorticoid may lead to improved recovery after operative procedures, this regimen has not been examined in patients undergoing abdominal wall reconstruction for repair of large ventral hernias. The aim of the current trial was to examine the effects of preoperative, single high-dose glucocorticoid on recovery after abdominal wall reconstruction. METHOD Forty patients undergoing abdominal wall reconstruction for repair of ventral incisional hernias with a horizontal fascial defect >10 cm were randomized to intravenous administration of either 125 mg methylprednisolone or placebo at the induction of anesthesia. The primary endpoint was pain in the supine position as assessed by a numeric rating scale of 0 to 10 at rest at 8 am on the first postoperative day. Secondary outcomes included postoperative pain during activity, nausea, fatigue, inflammatory response (measured by plasma levels of C-reactive protein), duration of stay, and 30-day complications or readmissions. RESULTS There was no difference in pain at rest on the first postoperative day (methylprednisolone mean 1.7 vs placebo 2.2, P > .95), whereas patients in the methylprednisolone group reported less pain during activity (mean 3.0 vs 5.0; P = .011) and during coughing (3.4 vs 5.9; P = .010). There were no differences between the 2 groups regarding postoperative fatigue or nausea. Postoperative levels of C-reactive protein were less in the methylprednisolone group (P = .039). CONCLUSION A single-shot, high-dose methylprednisolone before abdominal wall reconstruction for a large incisional hernia decreased early postoperative pain and attenuated the inflammatory response.",2020,"Postoperative levels of C-reactive protein were less in the methylprednisolone group (P = .039). ","['abdominal wall reconstruction', 'patients undergoing abdominal wall reconstruction for repair of large ventral hernias', 'Forty patients undergoing abdominal wall reconstruction for repair of ventral incisional hernias with a horizontal fascial defect >10 cm']","['methylprednisolone', 'glucocorticoid', 'methylprednisolone or placebo']","['postoperative pain during activity, nausea, fatigue, inflammatory response (measured by plasma levels of C-reactive protein), duration of stay, and 30-day complications or readmissions', 'pain during activity', 'postoperative fatigue or nausea', 'Postoperative levels of C-reactive protein', 'pain', 'pain in the supine position as assessed by a numeric rating scale of 0 to 10 at rest']","[{'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0019326', 'cui_str': 'Ventral Hernia'}, {'cui': 'C0750175', 'cui_str': 'Ventral incisional hernia'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C0222045'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}]",40.0,0.452762,"Postoperative levels of C-reactive protein were less in the methylprednisolone group (P = .039). ","[{'ForeName': 'Kristian K', 'Initials': 'KK', 'LastName': 'Jensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark. Electronic address: mail@kristiankiim.dk.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Brøndum', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Bonna', 'Initials': 'B', 'LastName': 'Leerhøy', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Belhage', 'Affiliation': 'Department of Anaesthesia, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hensler', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Regnar B', 'Initials': 'RB', 'LastName': 'Arnesen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}]",Surgery,['10.1016/j.surg.2019.12.007'] 616,32206812,Collaborative Home-Visit Program for Young Children With Motor Delays in Rural Taiwan: A Pilot Randomized Controlled Trial.,"BACKGROUND Caregiver engagement and collaborative team early childhood intervention (ECI) services are international trends; however, relevant evidence of collaborative home-visiting ECI in rural areas is as yet undetermined. OBJECTIVE The study aimed to investigate the effectiveness of a collaborative ECI program in a rural area of Taiwan. DESIGN The study was a pilot randomized control led trial. METHODS Children aged 6 to 33 months experiencing motor delays and their caregivers were enrolled in Taitung, Taiwan. Using stratified randomization, 24 participants were allocated to either experimental or control groups, and both received 5 home visits within 3 months. The experimental group received ECI services based on the International Classification of Functioning, Disability and Health framework and family-centered approaches. The control group received regular home visits by local social workers. Child outcomes included Pediatric Evaluation of Disability Inventory Chinese Version and Peabody Developmental Motor Scale, 2nd edition. Family outcomes included the Disability-Adapted Infant-Toddler version of Home Observation for Measurement, and Chinese versions of the Knowledge of Infant Development Inventory and Parental Stress Index-Short Form. A tester blinded to the study conducted assessments at baseline, postintervention, and 3-month follow-up. Two-way mixed analysis of variance was used with α = .05 (2-tailed). RESULTS The experimental group improved scores on the Disability-Adapted Infant-Toddler version of Home Observation for Measurement significantly more than the control group with an effect size of 0.64 at follow-up. In other outcomes, both groups showed no significant differences. The follow-up rate was 69%, and adherence to the ECI program was acceptable. LIMITATIONS A limitation of the study was the heterogeneity of the sample. CONCLUSIONS This pilot study revealed possible effectiveness in implementing collaborative ECI programs based on family-centered approaches and the International Classification of Functioning, Disability and Health in rural areas. Larger field studies are needed to confirm our findings.",2020,The experimental group improved scores on the DA-IT-HOME significantly more than the control group with ESf of 0.64 at follow-up.,"['Children aged 6 to 33 months experiencing motor delays and their caregivers were enrolled in Taitung, Taiwan', 'rural area of Taiwan', 'rural areas', 'Young Children With Motor Delays in Rural Taiwan']","['regular home visits by local social workers', 'collaborative ECI program', 'Collaborative Home-Visit Program', 'ECI services based on the International Classification of Functioning, Disability and Health (ICF) framework and family-centered approaches', 'Caregiver engagement and collaborative team early childhood intervention']","['Pediatric Evaluation of Disability Inventory Chinese Version and Peabody Developmental Motor Scale, 2nd Edition', 'Disability-Adapted Infant-Toddler version of Home Observation for Measurement', 'scores on the DA-IT-HOME']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0520947', 'cui_str': 'Clumsy child (finding)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2370861', 'cui_str': 'International Classification of Functioning, Disability and Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",24.0,0.0651495,The experimental group improved scores on the DA-IT-HOME significantly more than the control group with ESf of 0.64 at follow-up.,"[{'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Special Education, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Hua-Fang', 'Initials': 'HF', 'LastName': 'Liao', 'Affiliation': 'Academic Committee, Taiwan Society of ICF, 5th Floor, No. 166, Dayei Road, Baitou District, New Taipei City, Taiwan; and School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Suh-Fang', 'Initials': 'SF', 'LastName': 'Jeng', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University.'}, {'ForeName': 'Mei-Hui', 'Initials': 'MH', 'LastName': 'Tseng', 'Affiliation': 'School and Graduate Institute of Occupational Therapy, College of Medicine, National Taiwan University.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Schiariti', 'Affiliation': 'Division of Medical Sciences, University of Victoria, Victoria, British Columbia, Canada.'}, {'ForeName': 'Mei-Yan', 'Initials': 'MY', 'LastName': 'Tsai', 'Affiliation': 'Taiwan Social Welfare Action Alliance, Taitung, Taiwan.'}, {'ForeName': 'Sheh-Chia', 'Initials': 'SC', 'LastName': 'Sun', 'Affiliation': 'Department of Early Childhood Education, Teachers College, National Taitung University, Taitung County, Taiwan.'}]",Physical therapy,['10.1093/ptj/pzaa033'] 617,32402931,Long-term outcome of perioperative low cardiac output syndrome in cardiac surgery: 1-year results of a multicenter randomized trial.,"PURPOSE Perioperative myocardial dysfunction occurs frequently in cardiac surgery, and is a risk factor for morbidity and mortality. Levosimendan has been suggested to reduce mortality of patients with perioperative myocardial dysfunction. However, long-term outcome data on its efficacy in cardiac surgery are lacking. MATERIALS AND METHODS Cardiac surgery patients with perioperative myocardial dysfunction were randomized to levosimendan or placebo, in addition to standard inotropic care. One-year mortality data were collected. RESULTS We randomized 506 patients (248 to levosimendan 258 to placebo). At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60). Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass were independently associated with 1-year mortality. CONCLUSIONS Levosimendan administration does not improve 1-year survival in cardiac surgery patients with perioperative myocardial dysfunction. One-year mortality in these patients is 17%. Six predictive factors for long-term mortality were identified. STUDY REGISTRATION NUMBER NCT00994825 (ClinicalTrials.gov).",2020,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","['Cardiac surgery patients with perioperative myocardial dysfunction', 'cardiac surgery', 'cardiac surgery patients with perioperative myocardial dysfunction', '506 patients (248 to', 'patients with perioperative myocardial dysfunction']","['Levosimendan', 'perioperative low cardiac output syndrome', 'levosimendan', 'levosimendan 258 to placebo', 'levosimendan or placebo']","['Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass', '1-year survival']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0600177', 'cui_str': 'Low cardiac output syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",506.0,0.403453,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Novosibirsk State University, Novosibirsk, Russia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pisano', 'Affiliation': 'Division of Cardiac Anesthesia and Intensive Care Unit, AORN dei Colli - Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Calabrò', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Brazzi', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergency, Città della Salute e della Scienza Hospital, Turin, Italy; Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Grigoryev', 'Affiliation': 'Intensive Care Unit, Scientific Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Guarracino', 'Affiliation': 'Division of Cardiothoracic Anesthesia and Intensive Care, Department of Anesthesia and Critical Care Medicine, AOU Pisana, Pisa, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Anesthesia and Intensive Care, AOU Mater Domini Germaneto, Catanzaro, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crivellari', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valery V', 'Initials': 'VV', 'LastName': 'Likhvantsev', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia; V. Negovsky Reanimatology Research Institute, Moscow, Russia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Fominskiy', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Paternoster', 'Affiliation': 'Department of Anesthesia and Intensive Care, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Yavorovskiy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Pasyuga', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, Russia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Oriani', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bianchi', 'Affiliation': 'Department of Cardiovascular Anesthesia and Intensive Care, AO Ordine Mauriziano, Turin, Italy.'}, {'ForeName': 'A Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marat N', 'Initials': 'MN', 'LastName': 'Abubakirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Di Tomasso', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.04.005'] 618,32405121,Does moral reasoning influence public values for health care priority setting?: A population-based randomized stated preference survey.,"Objective Preferences of members of the public are recognized as important inputs into health care priority-setting, though knowledge of such preferences is scant. We sought to generate evidence of public preferences related to healthcare resource allocation among adults and children. Methods We conducted an experimental stated preference survey in a national sample of Canadian adults. Preferences were elicited across a range of scenarios and scored on a visual analogue scale. Intervention group participants were randomized to a moral reasoning exercise prior to each choice task. The main outcomes were the differences in mean preference scores by group, scenario, and demographics. Results Our results demonstrate a consistent preference by participants to allocate scarce health system resources to children. Exposure to the moral reasoning exercise weakened but did not eliminate this preference. Younger respondent age and parenthood were associated with greater preference for children. The top principles guiding participants' allocative decisions were treat equally, relieve suffering, and rescue those at risk of dying. Conclusions Our study affirms the relevance of age in public preferences for the allocation of scarce health care resources, demonstrating a significant preference by participants to allocate healthcare resources to children. However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access. Definitions of value in healthcare based on clinical benefit and cost-effectiveness may exclude moral considerations that the public values, such as equality and humanitarianism, highlighting opportunities to enrich healthcare priority-setting through public engagement.",2020,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","['experimental stated preference survey in a national sample of Canadian adults', 'adults and children']","['moral reasoning exercise', 'moral reasoning exercise prior to each choice task']","['mean preference scores by group, scenario, and demographics']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0701692,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","[{'ForeName': 'Avram E', 'Initials': 'AE', 'LastName': 'Denburg', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, M5G 1X8, Canada.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Ungar', 'Affiliation': 'Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, M5T 3M6, Canada.'}, {'ForeName': 'Shiyi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Biostatistician, Biostatistics, Design and Analysis, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, M5G 1X8, Canada.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Hurley', 'Affiliation': 'Department of Economics, McMaster University, Hamilton, L8S 4L8, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Abelson', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, L8S 4L8, Canada.'}]","Health policy (Amsterdam, Netherlands)",['10.1016/j.healthpol.2020.04.007'] 619,31482404,"Acute effect of orange chromatic environment on perceived health status, pain, and vital signs during chemotherapy treatment.","PURPOSE The study is aimed at assessing the acute effect of orange color and natural light exposure on cancer patients during chemotherapy sessions. Warmer environments and rooms receiving more sunlight hours were expected to impact vital signs, quality of life, and pain symptoms. METHODS We used a single-group repeated-measures clinical trial design. For the purpose of the study, chemotherapy rooms were modified based on two experimental factors: color (white vs. orange) and sunlight orientation (south vs. north). On four consecutive sessions, cancer patients were randomly assigned to one of the following conditions: orange-north, orange-south, white-north, and white-south. They received chemotherapy per standard of care. The following outcomes were assessed: blood pressure, body temperature, heart rate, and European Quality of Life Five-Dimension Five-Level Scale Questionnaire (EUROQOL-5D-5L) including the visual analogue scale (EQ-VAS). RESULTS Statistically significant beneficial effect of orange color room in self-rated health was found (p = 0.036, d = 0.28). Small differences in other parameters (body temperature, d = 0.34; diastolic blood pressure, d = 0.37; systolic blood pressure, d = 0.28) did not reach statistical significance. No differences were found based on room orientation. CONCLUSIONS Compared with a cool-color design, a warm-color living environment could have a positive effect on patients' well-being during chemotherapy sessions. Although the clinical effect size on perceived health status and vital signs could be considered small, the cost-effectiveness analysis would support the use of the proposed configurations. More research is still needed. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03873519.",2020,"Statistically significant beneficial effect of orange color room in self-rated health was found (p = 0.036, d = 0.28).",['cancer patients during chemotherapy sessions'],"['chemotherapy', 'orange chromatic environment', 'orange color and natural light exposure']","['self-rated health', 'diastolic blood pressure', 'impact vital signs, quality of life, and pain symptoms', 'systolic blood pressure', 'blood pressure, body temperature, heart rate, and European Quality of Life Five-Dimension Five-Level Scale Questionnaire (EUROQOL-5D-5L) including the visual analogue scale (EQ-VAS', 'perceived health status, pain, and vital signs']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1313858', 'cui_str': 'Orange color (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.058779,"Statistically significant beneficial effect of orange color room in self-rated health was found (p = 0.036, d = 0.28).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gómez-Vela', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain.'}, {'ForeName': 'María Fátima', 'Initials': 'MF', 'LastName': 'Hernández Martín', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Román', 'Affiliation': 'IOB Institute of Oncology, Quironsalud Group, Juan Bravo 39, 28006, Madrid, Spain.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University Health Sciences Center, 3106 4th Street, STOP 8183, Lubbock, TX, 79430, USA. eneko@cop.es.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05064-w'] 620,32200506,Comparison of two intense pulsed light patterns for treating patients with meibomian gland dysfunction.,"PURPOSE The objective of this was to determine the efficacy of different patterns of intense pulsed light (IPL) therapy in patients with meibomian gland dysfunction (MGD). MATERIALS AND METHOD IPL treatment was administered in 124 eyes of 62 patients with MGD-associated dry eye disease (DED). These patients were divided randomly into two groups treated with different IPL patterns. The first group was treated with ""Optimal Pulse Technology"" (OPT) (n = 29) and received three consecutive treatments (10-14 J/cm 2 ) with three weeks between treatments. The other group was treated with ""Intense Regulated Pulsed Light"" (IRPL) (n = 33) and received four treatments (9-13 J/cm 2 ) on days (D)1, D15, D45, and D75. The Ocular Surface Disease Index (OSDI), fluorescein breakup time (FTBUT), first and the average of noninvasive keratograph tear breakup times (NIKBUT), Schirmer I tests, conjunctival hyperemia, corneal fluorescent staining (CFS), tear meniscus height (TMH), MG secretion, and dropout were examined before each treatment and at one and three months after treatment. RESULTS Compared to baseline, the clinical symptoms and signs in both groups were significantly improved at one and three months after IPL treatment. However, compared to the IRPL group, the OPT-treated group showed significant improvement in the clarity of MG secretions (P = 0.001), the number of MGs yielding clear or cloudy liquid secretions (P < 0.001), the total MG secretion score (P < 0.001) in lower eyelid, the lid margin score in upper (P < 0.001) and lower eyelids (P = 0.013), the first NIKBUT (P = 0.009), and FTBUT (P = 0.006). CONCLUSIONS These results suggest that IPL has significant clinical value in treating patients with MGD. OPT IPL treatment was more effective in improving MG function in lower eyelids and partial tear film signs than IRPL IPL treatment. TRIAL REGISTRATION The study was registered at www.clinicaltrials.gov, and the clinical trial accession number is NCT02481167.",2020,"OPT IPL treatment was more effective in improving MG function in lower eyelids and partial tear film signs than IRPL IPL treatment. ","['124 eyes of 62 patients with MGD-associated dry eye disease (DED', 'patients with meibomian gland dysfunction', 'patients with MGD', 'patients with meibomian gland dysfunction (MGD']","['IRPL', 'Optimal Pulse Technology"" (OPT', 'intense pulsed light (IPL) therapy', 'OPT IPL', 'Intense Regulated Pulsed Light"" (IRPL', 'IPL']","['total MG secretion score', 'lower eyelids', 'number of MGs yielding clear or cloudy liquid secretions', 'clinical symptoms and signs', 'Ocular Surface Disease Index (OSDI), fluorescein breakup time (FTBUT), first and the average of noninvasive keratograph tear breakup times (NIKBUT), Schirmer I tests, conjunctival hyperemia, corneal fluorescent staining (CFS), tear meniscus height (TMH), MG secretion, and dropout', 'clarity of MG secretions', 'lid margin score']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3494304', 'cui_str': 'Intense Pulsed Light Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0205406', 'cui_str': 'Cloudy (qualifier value)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height (observable entity)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}]",62.0,0.0171384,"OPT IPL treatment was more effective in improving MG function in lower eyelids and partial tear film signs than IRPL IPL treatment. ","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Yinying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Yiqin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Yun-E', 'Initials': 'YE', 'LastName': 'Zhao', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China. zyehzeye@126.com.'}]",International ophthalmology,['10.1007/s10792-020-01337-0'] 621,31007057,Cognitive-Behavioral Therapy for Insomnia Tailored to Patients With Cardiovascular Disease: A Pre-Post Study.,"Objective : There is little research assessing the use of cognitive-behavioral therapy for insomnia (CBT-I) among patients with cardiovascular disease (CVD), even less on the effects of CBT-I on CVD risk factors such as anxiety and depression, and to our knowledge, only limited studies of the efficacy of CBT-I protocols with cardiac disease-specific modifications. The objective of this study is to evaluate a group-based CBT-I intervention tailored to patients with CVD on sleep quality, duration, and mental health. Participants : A sample of 47 participants (25 men) diagnosed with primary insomnia were included in this study. Methods : This study used a pre-post design comparing outcomes before and after a group intervention. Clinicians in a cardiac center referred CVD patients with self-reported sleep disturbance to the intervention group. Following screening and confirmation of insomnia disorder, participants completed a six-week CBT-I group-based intervention tailored for patients with CVD. Participants completed sleep diaries and questionnaires, including the Insomnia Severity Index, Beck Depression Inventory-II, and Beck Anxiety Inventory, pre- and postintervention. Results : Participants' sleep outcomes (sleep duration, maintenance, efficiency, latency, and quality) were significantly improved and patients reported significantly fewer symptoms of anxiety, depression, and insomnia following the CBT-I intervention ( p values < .05). Conclusions : After participating in a CBT-I group intervention tailored for cardiac patients, patients reported improved sleep and significantly lower levels of anxiety and depression. Randomized trials of this intervention are warranted.",2020,"After participating in a CBT-I group intervention tailored for cardiac patients, patients reported improved sleep and significantly lower levels of anxiety and depression.","['A sample of 47 participants (25 men) diagnosed with primary insomnia were included in this study', 'patients with cardiovascular disease (CVD', 'patients with CVD on sleep quality, duration, and mental health', 'Patients With Cardiovascular Disease']","['cognitive-behavioral therapy', 'Cognitive-Behavioral Therapy']","['levels of anxiety and depression', 'symptoms of anxiety, depression, and insomnia', 'sleep diaries and questionnaires, including the Insomnia Severity Index, Beck Depression Inventory-II, and Beck Anxiety Inventory, pre- and postintervention', 'sleep disturbance', 'sleep outcomes (sleep duration, maintenance, efficiency, latency, and quality']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033139', 'cui_str': 'Primary Insomnia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",47.0,0.0382278,"After participating in a CBT-I group intervention tailored for cardiac patients, patients reported improved sleep and significantly lower levels of anxiety and depression.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Heenan', 'Affiliation': 'Division of cardiac prevention and rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipe', 'Affiliation': 'Division of cardiac prevention and rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Lemay', 'Affiliation': 'Division of cardiac prevention and rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Davidson', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Tulloch', 'Affiliation': 'Division of cardiac prevention and rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1594815'] 622,32401418,Impact of pulsed electromagnetic field therapy on vascular function and blood pressure in hypertensive individuals.,"The present study investigated the impact of 12 weeks of pulsed electromagnetic field (PEMF) therapy on peripheral vascular function, blood pressure (BP), and nitric oxide in hypertensive individuals. Thirty hypertensive individuals (SBP > 130 mm Hg and/or MAP > 100 mm Hg) were assigned to either PEMF group (n = 15) or control group (n = 15). During pre-assessment, participants underwent measures of flow-mediated dilation (FMD), BP, and blood draw for nitric oxide (NO). Subsequently, they received PEMF therapy 3x/day for 12 weeks and, at conclusion, returned to the laboratory for post-assessment. Fifteen participants from the PEMF group and 11 participants from the control group successfully completed the study protocol. After therapy, the PEMF group demonstrated significant improvements in FMD and FMD NOR (normalized to hyperemia), but the control group did not (P = .05 and P = .04, respectively). Moreover, SBP, DBP, and MAP were reduced, but the control group did not (P = .04, .04, and .03, respectively). There were no significant alterations in NO in both groups (P > .05). Twelve weeks of PEMF therapy may improve BP and vascular function in hypertensive individuals. Additional studies are needed to identify the mechanisms by which PEMF affects endothelial function.",2020,"After therapy, the PEMF group demonstrated significant improvements in FMD and FMD NOR (normalized to hyperemia), but the control group did not (P = .05 and P = .04, respectively).","['Fifteen participants from the PEMF group and 11 participants from the control group successfully completed the study protocol', '100\xa0mm\xa0Hg', 'hypertensive individuals', 'Thirty hypertensive individuals (SBP\xa0>\xa0130\xa0mm']","['PEMF therapy', 'pulsed electromagnetic field (PEMF) therapy', 'pulsed electromagnetic field therapy', 'PEMF']","['flow-mediated dilation (FMD), BP, and blood draw for nitric oxide (NO', 'FMD and FMD NOR', 'SBP, DBP, and MAP', 'BP and vascular function', 'peripheral vascular function, blood pressure (BP), and nitric oxide', 'vascular function and blood pressure']","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",30.0,0.0517984,"After therapy, the PEMF group demonstrated significant improvements in FMD and FMD NOR (normalized to hyperemia), but the control group did not (P = .05 and P = .04, respectively).","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Stewart', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Wheatley-Guy', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Johnson', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Win K', 'Initials': 'WK', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Chul-Ho', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13877'] 623,31278907,High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial.,"BACKGROUND AND AIMS Hypoxia is one of the most frequent adverse events with sedated GI endoscopy and can lead to serious consequences. No modalities have been found previously to prevent hypoxia. High-flow nasal cannula (HFNC) supportive oxygen therapy provides heated and humidified oxygen up to 60 L/minute. Because of its ability to improve respiratory function and good tolerance, we aimed to evaluate the validity and safety of HFNC supportive oxygen therapy in preventing the incidence of hypoxia in patients undergoing gastroscopy with propofol sedation. METHODS In a multicenter, prospective randomized single-blinded study, 1994 outpatients undergoing routine gastroscopy with propofol sedation provided by an anesthesiologist were randomized into 2 groups: the nasal cannula group (O 2 [2 L/minute] was supplied via an HFNC) and the HFNC group (O 2 [30-60 L/minute] was supplied via an HFNC) at 3 centers from November 2017 to February 2018. The primary outcome was the incidence of hypoxia. Other adverse events were also recorded. RESULTS HFNC supportive oxygen therapy decreased the incidence of hypoxia (75% ≤ Spo 2  < 90% for <60 seconds) and severe hypoxia (Spo 2  < 75% for any duration or 75% ≤ Spo 2  < 90% for ≥60 seconds) from 8.4% to 0% (P < .001) and from 0.6% to 0% (P = .03), respectively. The only HFNC-related adverse event was xeromycteria/rhinalgia (1.7%), which was observed 1 minute after the procedure and disappeared after 30 minutes. CONCLUSIONS HFNC supportive oxygen therapy can prevent the incidence of hypoxia and severe hypoxia in patients in America Society of Anesthesiologists class I-II undergoing elective gastroscopy under propofol sedation, with minimal related adverse events and good tolerance. (Clinical trial registration number: NCT03332433.).",2019,"RESULTS HFNC supportive oxygen therapy decreased the incidence of hypoxia (75% ≤ SpO 2 < 90% for <60 s) and severe hypoxia (SpO 2 <75% for any duration or 75% ≤ SpO 2 <90% for ≥60 s) from 8.4% to 0% (P < 0.001) and from 0.6% to 0% (P = 0.03), respectively.","['1,994 outpatients undergoing routine gastroscopy with propofol sedation provided by an anesthesiologist', 'patients with ASA I-II undergoing elective gastroscopy under propofol sedation', 'patients undergoing gastroscopy with propofol sedation']","['nasal cannula group (O 2 [2 L/min] was supplied via an HFNC) and the HFNC group (O 2 [30-60 L/min] was supplied via an HFNC', 'HFNC supportive oxygen therapy', 'High-flow nasal cannula (HFNC', 'propofol sedation', 'supportive oxygen therapy', 'High-flow nasal cannula oxygen therapy and hypoxia']","['incidence of hypoxia and severe hypoxia', 'severe hypoxia', 'incidence of hypoxia']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",1994.0,0.119475,"RESULTS HFNC supportive oxygen therapy decreased the incidence of hypoxia (75% ≤ SpO 2 < 90% for <60 s) and severe hypoxia (SpO 2 <75% for any duration or 75% ≤ SpO 2 <90% for ≥60 s) from 8.4% to 0% (P < 0.001) and from 0.6% to 0% (P = 0.03), respectively.","[{'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Tongji Hospital affiliated to Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200092, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Pudong New Area People's Hospital, 490 South Chuanhuan Road, Shanghai, 201200, China.""}, {'ForeName': 'Mengyun', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Anesthesiology, Shanghai Tongji Hospital affiliated to Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200092, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, Pudong New Area People's Hospital, 490 South Chuanhuan Road, Shanghai, 201200, China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Diansan', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, 160 Pujian Road, Shanghai, 200127, China.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.06.033'] 624,32199123,Randomised comparison of two household survey modules for measuring stillbirths and neonatal deaths in five countries: the Every Newborn-INDEPTH study.,"BACKGROUND An estimated 5·1 million stillbirths and neonatal deaths occur annually. Household surveys, most notably the Demographic and Health Survey (DHS), run in more than 90 countries and are the main data source from the highest burden regions, but data-quality concerns remain. We aimed to compare two questionnaires: a full birth history module with additional questions on pregnancy losses (FBH+; the current DHS standard) and a full pregnancy history module (FPH), which collects information on all livebirths, stillbirths, miscarriages, and neonatal deaths. METHODS Women residing in five Health and Demographic Surveillance System sites within the INDEPTH Network (Bandim in Guinea-Bissau, Dabat in Ethiopia, IgangaMayuge in Uganda, Matlab in Bangladesh, and Kintampo in Ghana) were randomly assigned (individually) to be interviewed using either FBH+ or FPH between July 28, 2017, and Aug 13, 2018. The primary outcomes were stillbirths and neonatal deaths in the 5 years before the survey interview (measured by stillbirth rate [SBR] and neonatal mortality rate [NMR]) and mean time taken to complete the maternity history section of the questionnaire. We also assessed between-site heterogeneity. This study is registered with the Research Registry, 4720. FINDINGS 69 176 women were allocated to be interviewed by either FBH+ (n=34 805) or FPH (n=34 371). The mean time taken to complete FPH (10·5 min) was longer than for FBH+ (9·1 min; p<0·0001). Using FPH, the estimated SBR was 17·4 per 1000 total births, 21% (95% CI -10 to 62) higher than with FBH+ (15·2 per 1000 total births; p=0·20) in the 5 years preceding the survey interview. There was strong evidence of between-site heterogeneity (I 2 =80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites. The estimated NMR did not differ between modules (FPH 25·1 per 1000 livebirths vs FBH+ 25·4 per 1000 livebirths), with no evidence of between-site heterogeneity (I 2 =0·7%; p=0·40). INTERPRETATION FPH takes an average of 1·4 min longer to complete than does FBH+, but has the potential to increase reporting of stillbirths in high burden contexts. The between-site heterogeneity we found might reflect variations in interviewer training and survey implementation, emphasising the importance of interviewer skills, training, and consistent implementation in data quality. FUNDING Children's Investment Fund Foundation.",2020,"There was strong evidence of between-site heterogeneity (I 2 =80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites.","['69', '176 women', 'Women residing in five Health and Demographic Surveillance System sites within the INDEPTH Network (Bandim in Guinea-Bissau, Dabat in Ethiopia, IgangaMayuge in Uganda, Matlab in Bangladesh, and Kintampo in Ghana']","['FBH', 'full birth history module with additional questions on pregnancy losses (FBH+; the current DHS standard) and a full pregnancy history module (FPH', 'FPH', 'FBH+ or FPH']","['estimated NMR', 'mean time taken to complete FPH', 'stillbirths and neonatal deaths in the 5 years before the survey interview (measured by stillbirth rate [SBR] and neonatal mortality rate [NMR]) and mean time taken to complete the maternity history section of the questionnaire', 'SBR higher for FPH']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0018387', 'cui_str': 'Portuguese Guinea'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0005603', 'cui_str': 'Birth History'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032967', 'cui_str': 'Pregnancy History'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",69176.0,0.0722441,"There was strong evidence of between-site heterogeneity (I 2 =80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Akuze', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK; Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda. Electronic address: jakuze@musph.ac.ug.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Blencowe', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Waiswa', 'Affiliation': 'Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda; Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Baschieri', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Vladimir S', 'Initials': 'VS', 'LastName': 'Gordeev', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK; The Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Kwesiga', 'Affiliation': 'Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Ane B', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'Bandim Health Project, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; Odense Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sanne M', 'Initials': 'SM', 'LastName': 'Thysen', 'Affiliation': 'Bandim Health Project, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; Center for Global Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Amabelia', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Bandim Health Project, Bissau, Guinea-Bissau.'}, {'ForeName': 'Gashaw A', 'Initials': 'GA', 'LastName': 'Biks', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Solomon M', 'Initials': 'SM', 'LastName': 'Abebe', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Kassahun A', 'Initials': 'KA', 'LastName': 'Gelaye', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Mezgebu Y', 'Initials': 'MY', 'LastName': 'Mengistu', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Bisrat M', 'Initials': 'BM', 'LastName': 'Geremew', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Tadesse G', 'Initials': 'TG', 'LastName': 'Delele', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Adane K', 'Initials': 'AK', 'LastName': 'Tesega', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Temesgen A', 'Initials': 'TA', 'LastName': 'Yitayew', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kasasa', 'Affiliation': 'Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda; IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Galiwango', 'Affiliation': 'IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Davis', 'Initials': 'D', 'LastName': 'Natukwatsa', 'Affiliation': 'IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Kajungu', 'Affiliation': 'IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Yeetey Ak', 'Initials': 'YA', 'LastName': 'Enuameh', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti, Ghana; Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Obed E', 'Initials': 'OE', 'LastName': 'Nettey', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Dzabeng', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Seeba', 'Initials': 'S', 'LastName': 'Amenga-Etego', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Sam K', 'Initials': 'SK', 'LastName': 'Newton', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti, Ghana; Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Tawiah', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Malaria Centre, London School of Hygiene & Tropical Medicine, London, UK; Kintampo Health Research Centre, Kintampo, Ghana; University of Health and Allied Sciences, Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Alam', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Moinuddin M', 'Initials': 'MM', 'LastName': 'Haider', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Imam', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Kaiser', 'Initials': 'K', 'LastName': 'Mahmud', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joy E', 'Initials': 'JE', 'LastName': 'Lawn', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30044-9'] 625,32406111,Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal.,"CRADLE was a 36-month multicenter study in pediatric (≥1 to <18 years) kidney transplant recipients randomized at 4 to 6 weeks posttransplant to receive everolimus + reduced-exposure tacrolimus (EVR + rTAC; n = 52) with corticosteroid withdrawal at 6-month posttransplant or continue mycophenolate mofetil + standard-exposure TAC (MMF + sTAC; n = 54) with corticosteroids. The incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death) at month 36 was 9.8% vs 9.6% (difference: 0.2%; 80% confidence interval: -7.3 to 7.7) for EVR + rTAC and MMF + sTAC, respectively, which was driven by BPARs. Graft loss was low (2.1% vs 3.8%) with no deaths. Mean estimated glomerular filtration rate at month 36 was comparable between groups (68.1 vs 67.3 mL/min/1.73 m 2 ). Mean changes (z-score) in height (0.72 vs 0.39; P = .158) and weight (0.61 vs 0.82; P = .453) from randomization to month 36 were comparable, whereas growth in prepubertal patients on EVR + rTAC was better (P = .050) vs MMF + sTAC. The overall incidence of adverse events (AEs) and serious AEs was comparable between groups. Rejection was the leading AE for study drug discontinuation in the EVR + rTAC group. In conclusion, though AE-related study drug discontinuation was higher, an EVR + rTAC regimen represents an alternative treatment option that enables withdrawal of steroids as well as reduction of CNIs for pediatric kidney transplant recipients. ClinicalTrials.gov: NCT01544491.",2020,"Mean changes (z-score) in height (0.72 vs 0.39; P=0.158) and weight (0.61 vs 0.82; P=0.453) from randomization to Month 36 were comparable, while growth in pre-pubertal patients on EVR+rTAC was better (P=0.050) versus MMF+sTAC.","['pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal', 'pediatric (≥1 to <18 years) kidney transplant recipients randomized at']",['4-6 weeks post-transplantation to receive everolimus+reduced-exposure tacrolimus (EVR+rTAC; N=52) with corticosteriod withdrawal at 6-month post-transplantation or continue mycophenolate mofetil+standard-exposure TAC (MMF+sTAC; N=54) with corticosteroids'],"['incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death', 'weight', 'Mean estimated glomerular filtration rate', 'overall incidence of adverse events (AEs) and serious AEs', 'Graft loss']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0550015,"Mean changes (z-score) in height (0.72 vs 0.39; P=0.158) and weight (0.61 vs 0.82; P=0.453) from randomization to Month 36 were comparable, while growth in pre-pubertal patients on EVR+rTAC was better (P=0.050) versus MMF+sTAC.","[{'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva', 'Affiliation': 'Nephrology Division, Hospital do Rim, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ettenger', 'Affiliation': ""Division of Pediatric Nephrology, UCLA Mattel Children's Hospital, Los Angeles, California, USA.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': ""Department of Pediatric Nephrology, Nottingham Children's Hospital, Nottingham, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjerre', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Department of Pediatrics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dello Strologo', 'Affiliation': ""Nephrology Unit, Department of Pediatrics, Institute for Scientific Research, Bambino Gesù Children's Hospital, Rome, Italy.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Marks', 'Affiliation': 'Department of Pediatric Nephrology, Great Ormond Street Hospital for Children, NHS Foundation Trust and University College London Great Ormond Street Institute of Child Health, NIHR Great Ormond Street Hospital Biomedical Research Centre, London, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Udaykiran', 'Initials': 'U', 'LastName': 'Veldandi', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cousin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Pandey', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16005'] 626,32176711,Representation of patients with a migration background in studies on antithrombotic treatment. An analysis of recruitment data from a cluster randomized controlled trial.,"BACKGROUND The health status, health awareness and health behavior of persons with a migration background often differ from the autochthonous population. Little is known about the proportion of patients with a migration background (PMB) that participate in primary care studies on oral antithrombotic treatment (OAT) in Germany, and whether the quality of their antithrombotic care differs from patients without a migration background. The aim of this paper was to use the results of a cluster-randomized controlled trial (PICANT) to determine the proportion of PMB at different stages of recruitment, and to compare the results in terms of sociodemographic characteristics and antithrombotic treatment. METHODS This study used screening and baseline data from the PICANT trial on oral anticoagulation management in GP practices. For this analysis, we determined the proportion of PMB during the recruitment period at stage 1 (screening of potentially eligible patients), stage 2 (eligible patients invited to participate in the trial), and stage 3 (assessment of baseline characteristics of patients participating in the PICANT trial). In addition, we compared patients in terms of sociodemographic characteristics and quality of anticoagulant treatment. Statistical analysis comprised descriptive and bivariate analyses. RESULTS The proportion of PMB at each recruitment stage declined from 9.1% at stage 1 to 7.9% at stage 2 and 7.3% at stage 3). A lack of German language skills led to the exclusion of half the otherwise eligible PMB. At stages 1 and 3, PMB were younger (stage 1: 70.7 vs. 75.0 years, p<0.001; stage 3: 70.2 vs. 73.5 years, p = 0.013), but did not differ in terms of gender. The quality of their anticoagulant care was comparable (100.0% vs. 99.1% were receiving appropriate OAT, 94.4% vs. 95.7% took phenprocoumon, or warfarin, and the most recent INR measurement of 60.8% vs. 69.3% was within their individual INR range). CONCLUSIONS In the potentially eligible population and among participants at baseline, the quality of anticoagulant care was high in all groups of patients, which is reassuring. To enable the inclusion of more PMB, future primary care research on OAT in Germany should address how best to overcome language barriers. This will be challenging, particularly because the heterogeneity of PMB means the resulting sample sizes for each specific language group are small. TRIAL REGISTRATION Current Controlled Trials ISRCTN41847489.",2020,"In the potentially eligible population and among participants at baseline, the quality of anticoagulant care was high in all groups of patients, which is reassuring.","['GP practices', 'potentially eligible patients), stage 2 (eligible patients invited to participate in the trial), and stage 3 (assessment of baseline characteristics of patients participating in the PICANT trial', 'patients with a migration background in studies on antithrombotic treatment']",[],"['quality of their anticoagulant care', 'quality of anticoagulant care', 'proportion of PMB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]",,0.201566,"In the potentially eligible population and among participants at baseline, the quality of anticoagulant care was high in all groups of patients, which is reassuring.","[{'ForeName': 'Karola', 'Initials': 'K', 'LastName': 'Mergenthal', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Siebenhofer', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Lisa-R', 'Initials': 'LR', 'LastName': 'Ulrich', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Guethlin', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Ferdinand M', 'Initials': 'FM', 'LastName': 'Gerlach', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Juliana J', 'Initials': 'JJ', 'LastName': 'Petersen', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0230297'] 627,32200381,The Effect of Moderate Weight Loss on a Non-Invasive Biomarker of Liver Fibrosis: A Randomised Controlled Trial.,"BACKGROUND Referral to weight loss programmes is the only effective treatment for non-alcoholic fatty liver disease (NAFLD). Clinicians should advise weight loss and screen for liver fibrosis using the Enhanced Liver Fibrosis (ELF) score. AIM To examine if the ELF score changes with weight loss. DESIGN AND SETTING Randomised controlled trial (ISRCTN85485463) in UK primary care during 2007-2008. METHOD Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease were randomised to attend a community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse (n = 28). Weight and the ELF score were measured at baseline and 1 year. Analysis of covariance examined mean changes in the ELF score between groups and its relationship with weight loss. RESULTS Mean (SD) BMI was 31.10 kg/m2 (2.55) with evidence of moderate levels of liver fibrosis at baseline (mean ELF score: 8.93 [0.99]). There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30). Mean weight loss in the whole cohort was 7.8% (5.9). There was no evidence of an association between weight change and change in ELF; the coefficient for a 5% weight loss was -0.15 (95% CI: -0.30 to 0.0002). CONCLUSION We found no evidence that the ELF score changed meaningfully following moderate weight loss. Clinicians should not use the ELF score to measure improvements in NAFLD fibrosis following weight loss programmes.",2020,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","['Liver Fibrosis', 'Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease']",['community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse'],"['Mean (SD) BMI', 'weight loss', 'ELF score', 'liver fibrosis', 'Weight and the ELF score', 'weight change and change in ELF', 'Mean weight loss']","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0843843,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","[{'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, dimitrios.koutoukidis@phc.ox.ac.uk.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000505667'] 628,32200994,High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation in critically ill patients with COVID-19 pneumonia: a prospective randomised controlled trial.,,2020,,['critically ill patients with COVID-19 pneumonia'],['High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation'],[],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'TS-COV19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",[],,0.33431,,"[{'ForeName': 'Cai-Neng', 'Initials': 'CN', 'LastName': 'Wu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Lin-Zhi', 'Initials': 'LZ', 'LastName': 'Xia', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Kun-Hong', 'Initials': 'KH', 'LastName': 'Li', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Wu-Hua', 'Initials': 'WH', 'LastName': 'Ma', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Dong-Nan', 'Initials': 'DN', 'LastName': 'Yu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bi-Xi', 'Initials': 'BX', 'LastName': 'Li', 'Affiliation': 'Wuhan, China. Electronic address: bxlee@sohu.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Guangzhou, China. Electronic address: yingcao1986@163.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.020'] 629,31541424,"Comparison of Lacrosse Non-Slip Elements and Cutting Balloons in Treating Calcified Coronary Lesions: a Retrospective, Single-Blind Randomized Controlled Study.","INTRODUCTION The present study aimed to compare Lacrosse non-slip elements (NSE) and cutting balloons in treating calcified coronary lesions. METHODS A retrospective analysis was performed in 79 patients, who were diagnosed with moderate to severe calcified coronary lesions by coronary angiography, and underwent interventional therapy from January to December 2017. Lacrosse NSEs were used in 41 patients, while cutting balloons were used in 38 patients. The basic clinical characteristics, angiographic images, perioperative parameters, operation durations, interventional complications and incidence of major adverse cardiovascular events were compared. RESULTS There was no significant difference in age, gender and risk factors between the two groups (P > 0.05). Furthermore, there was no significant difference in operation duration, and perioperative and postoperative complications between the two groups (P > 0.05). CONCLUSION Compared with cutting balloons, the Lacrosse NSE has a similar effect in treating moderate to severe calcified coronary lesions.",2019,"There was no significant difference in age, gender and risk factors between the two groups (P > 0.05).","['Treating Calcified Coronary Lesions', '79 patients, who were diagnosed with moderate to severe calcified coronary lesions by coronary angiography, and underwent interventional therapy from January to December 2017']","['Lacrosse Non-Slip Elements and Cutting Balloons', 'Lacrosse non-slip elements (NSE) and cutting balloons']","['angiographic images, perioperative parameters, operation durations, interventional complications and incidence of major adverse cardiovascular events', 'operation duration, and perioperative and postoperative complications']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0022909', 'cui_str': 'Lacrosse'}, {'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",79.0,0.0245896,"There was no significant difference in age, gender and risk factors between the two groups (P > 0.05).","[{'ForeName': 'Xin-Yong', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Emergency Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, 100029, China. xyzdr_666@163.com.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Emergency Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, 100029, China.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Zeng', 'Affiliation': 'Emergency Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, 100029, China.'}, {'ForeName': 'Shao-Ping', 'Initials': 'SP', 'LastName': 'Nie', 'Affiliation': 'Emergency Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, 100029, China.'}]",Advances in therapy,['10.1007/s12325-019-01072-8'] 630,31512143,"Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study.","INTRODUCTION Therapeutic effects of cannabidiol (CBD) in specialized populations continue to emerge. Despite supra-physiological dosing being shown to be tolerable in various pathologies, optimization of CBD absorption has obvious benefits for general health and recreational usage. Our objectives were to: (1) to investigate a joint pharmacokinetic-physiological time course of multiple recreational-equivalent (< 100 mg) dosages of oral CBD in young healthy adults and (2) evaluate a newly developed technology (TurboCBD™) for the enhanced delivery of CBD. METHODS In a double-blinded, placebo-controlled, cross-over design, 12 participants received placebo, generic 45 or 90 mg of CBD, or TurboCBD™ delivery technology capsules on five separate occasions. RESULTS Although there were no differences in the 45 mg conditions, circulating CBD levels were higher with the TurboCBD™ 90 mg group at both 90 (+ 86%) and 120 (+ 65%) min compared with the 90 mg control (p < 0.05). Total area under the curve tended to be higher with TurboCBD™ 90 mg compared with 90 mg (10,865 ± 6322 ng ml -1 vs. 7114 ± 2978 ng ml -1 ; p = 0.088). Only the TurboCBD™ 90 mg dose was elevated greater than placebo at 30 min (p = 0.017) and remained elevated at 4 h (p = 0.002). CONCLUSION Consistent with higher bioavailability, TurboCBD™ 90 mg at the peak CBD concentration was associated with an increase in cerebral perfusion and slight reduction in blood pressure compared with baseline and the 90 mg control. Further studies are needed to establish the mechanisms of action of this technology and to explore the therapeutic potential of acute and chronic dosing on more at-risk populations. FUNDING Lexaria Bioscience Corp. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03295903.",2019,"Only the TurboCBD™ 90 mg dose was elevated greater than placebo at 30 min (p = 0.017) and remained elevated at 4 h (p = 0.002). ","['Healthy Subjects', 'young healthy adults and (2) evaluate a newly developed technology (TurboCBD™) for the enhanced delivery of CBD']","['Placebo', 'cannabidiol (CBD', 'multiple recreational-equivalent (<\u2009100\xa0mg) dosages of oral CBD', 'placebo, generic 45 or 90\xa0mg of CBD, or TurboCBD', 'placebo']","['circulating CBD levels', 'cerebral perfusion', 'blood pressure']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",12.0,0.258088,"Only the TurboCBD™ 90 mg dose was elevated greater than placebo at 30 min (p = 0.017) and remained elevated at 4 h (p = 0.002). ","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Patrician', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia, 3333 University Way, Kelowna, BC, V1V 1V7, Canada. amdpatrician@gmail.com.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Versic-Bratincevic', 'Affiliation': 'Department of Toxicology and Pharmacogenetics, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Mijacika', 'Affiliation': 'Department of Integrative Physiology, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Banic', 'Affiliation': 'Department of Integrative Physiology, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Marendic', 'Affiliation': 'Department of Health Studies, University of Split, Ruđera Boškovića 35, 21000, Split, Croatia.'}, {'ForeName': 'Davorka', 'Initials': 'D', 'LastName': 'Sutlović', 'Affiliation': 'Department of Toxicology and Pharmacogenetics, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Dujić', 'Affiliation': 'Department of Integrative Physiology, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia, 3333 University Way, Kelowna, BC, V1V 1V7, Canada.'}]",Advances in therapy,['10.1007/s12325-019-01074-6'] 631,31962344,Activation of D1 receptors affects human reactivity and flexibility to valued cues.,"Reward-predicting cues motivate goal-directed behavior, but in unstable environments humans must also be able to flexibly update cue-reward associations. While the capacity of reward cues to trigger motivation ('reactivity') as well as flexibility in cue-reward associations have been linked to the neurotransmitter dopamine in humans, the specific contribution of the dopamine D1 receptor family to these behaviors remained elusive. To fill this gap, we conducted a randomized, placebo-controlled, double-blind pharmacological study testing the impact of three different doses of a novel D1 agonist (relative to placebo) on reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning). We observed that the impact of the D1 agonist crucially depended on baseline working memory functioning, which has been identified as a proxy for baseline dopamine synthesis capacity. Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity. In contrast, higher doses of the D1 agonist improved reversal learning only in individuals with low baseline working memory functioning. Our findings suggest a crucial and baseline-dependent role of D1 receptor activation in controlling both cue reactivity and the flexibility of cue-reward associations.",2020,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.",[],"['novel D1 agonist (relative to placebo', 'placebo']","['reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning', 'reversal learning']",[],"[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.119234,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Soutschek', 'Affiliation': 'Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany. Alexander.Soutschek@psy.lmu.de.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Takeda Pharmaceuticals International, Cambridge, MA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'de Martinis', 'Affiliation': 'Praxis Precision Medicines, Cambridge, MA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Howe', 'Affiliation': 'School of Neuroscience, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Burke', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jetter', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0617-z'] 632,30773058,Psychomotor Performance Decrements following a Successful Physical Activity Intervention for Insomnia.,"Objectives : Evidence supports the view that reductions in cognitive hyperarousal contribute substantially to improved sleep outcomes following cognitive and behavioral interventions for insomnia disorder. Assuming an inverted-u relationship between arousal and performance, a theoretical possibility, supported by limited empirical data, is that the same mediating processes could negatively impact aspects of psychomotor performance, reducing speed on tests of reaction time. Participants : Sedentary participants (mean age = 59.8; SD = 9.46) meeting research diagnostic criteria for insomnia were randomized to either an exercise intervention of ≥150 min of moderate-intensity activity per week (n = 20), or a wait-list control group (n = 21). Of these, n = 17 intervention and n = 18 control participants completed 6-month follow-up assessments. Methods : Digit span, and simple and complex vigilance task performance was assessed using a computerized protocol at baseline and 6-month follow-up. Dependent variables included digit span, simple reaction time (SRT), complex reaction time (CRT), false positive responses, number of lapses, and SRT/CRT ratio (indicative of the magnitude of difference between simple and complex RT performance). The primary clinical outcome was Insomnia Severity Index (ISI) score. Results : In comparisons of baseline to follow-up change, ISI scores showed clinically significant improvement in the intervention group at 6-month follow-up (F (8,26) = 5.16; P = 0.03). Baseline vigilance performance was equivalent in both groups. At 6-month follow-up, however, the intervention group showed significantly slower simple reaction time F(4,30) = 10.25, p < 0.01, and a significantly decreased SRT/CRT ratio (F(4,30) = 13.22, p < 0.01). Conclusions : Among people meeting diagnostic criteria for insomnia, beneficial sleep outcomes following successful behavioral interventions may, under some circumstances, come at the cost of slower psychomotor performance.",2020,"Dependent variables included digit span, simple reaction time (SRT), complex reaction time (CRT), false positive responses, number of lapses, and SRT/CRT ratio (indicative of the magnitude of difference between simple and complex RT performance).","['Sedentary participants (mean age\xa0=\xa059.8; SD\xa0=\xa09.46) meeting research diagnostic criteria for insomnia', 'insomnia disorder']","['exercise intervention of ≥150\xa0min of moderate-intensity activity per week (n\xa0=\xa020), or a wait-list control group', 'cognitive and behavioral interventions', 'Successful Physical Activity Intervention']","['Psychomotor Performance Decrements', 'slower simple reaction time F(4,30)\xa0', 'ISI scores', 'Baseline vigilance performance', 'digit span, simple reaction time (SRT), complex reaction time (CRT), false positive responses, number of lapses, and SRT/CRT ratio (indicative of the magnitude of difference between simple and complex RT performance', 'Insomnia Severity Index (ISI) score', 'SRT/CRT ratio', 'Digit span, and simple and complex vigilance task performance']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0035168'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C4706228', 'cui_str': 'Insomnia Severity Index score (observable entity)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0902954,"Dependent variables included digit span, simple reaction time (SRT), complex reaction time (CRT), false positive responses, number of lapses, and SRT/CRT ratio (indicative of the magnitude of difference between simple and complex RT performance).","[{'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Hartescu', 'Affiliation': 'Clinical Sleep Research Unit, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'Clinical Sleep Research Unit, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Clare D', 'Initials': 'CD', 'LastName': 'Stevinson', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1578774'] 633,32040875,"Atraumatic restorative treatments reduce the need for dental general anaesthesia: a non-inferiority randomized, controlled trial.","BACKGROUND A dental general anaesthesia (DGA) is commonly undertaken for the management of dental caries in young children. A randomized-controlled trial was undertaken to test the feasibility of using the Atraumatic Restorative Treatment and Hall Technique approaches (ART/HT) to manage the dental treatment of children recommended for a DGA. METHODS Consenting children, recommended a DGA for caries management, at the Oral Health Centre of Western Australia were randomized. Test group children were treated using the ART/HT approach and the control group under a DGA. Children were examined after 12 months by two blinded, calibrated examiners. Analysis was on an intention to treat basis; between and within group comparisons were undertaken using appropriate paired and unpaired tests. Logistic regression was used to test restorative success, controlling for clustering of teeth. RESULTS Sixty-five children participated, (Test = 32; Control = 33). At study termination, 28 children (88%) in the ART/HT group and 20 children (61%) in the DGA group had been provided with care, P < 0.01. Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, P < 0.01). CONCLUSION Use of the ART/HT approach enabled timely dental treatment of young children recommended for a DGA, and should be among the treatment options considered.",2020,"Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, p<0.01). ","['Dental General Anaesthesia', 'children recommended for a DGA', 'young children', '28 children (88%) in the ART/HT group and 20 children (61%) in the DGA group had been provided with care, p<0.01', 'Consenting children, recommended a DGA for caries management, at the Oral Health Centre of Western Australia were randomised']","['ART/HT approach and the control group under a DGA', 'dental general anaesthesia (DGA', 'Atraumatic Restorative Treatment and Hall Technique approaches (ART/HT', 'ART/HT approach', 'Atraumatic Restorative Treatments']",[],"[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0029162'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2356088', 'cui_str': 'Halls'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",[],65.0,0.148147,"Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, p<0.01). ","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Dental Health Services, Perth, Western Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Forrest', 'Affiliation': 'Dental Health Services, Perth, Western Australia.'}]",Australian dental journal,['10.1111/adj.12749'] 634,32190781,Barriers and solutions to implementing a pragmatic diabetes education trial in rural primary care clinics.,"Introduction The purpose of this report is to describe barriers and solutions to the implementation and optimization of a pragmatic trial that tests an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care in rural primary care clinics. Methods The two-arm pragmatic trial has been implemented in six rural family medicine clinics in Arkansas. It tests a self-management education and counseling intervention for patients with type 2 diabetes compared to enhanced usual care. Barriers and solutions were identified as issues arose and through interviews with clinic directors and clinic administrators and a focus group, interviews, and tracking reports with clinic health coaches who delivered the intervention. Results Barriers to optimizing enrollment, intervention delivery, and data collection were addressed through targeted education of and relationship building with leadership, changing enrollment oversight, and ongoing training of health coaches. Conclusions Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.",2020,"Conclusions Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.","['patients with type 2 diabetes', 'six rural family medicine clinics in Arkansas', 'rural primary care clinics']",['self-management education and counseling intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3833703', 'cui_str': 'Family medicine clinic (environment)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",[],6.0,0.0319957,"Conclusions Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.","[{'ForeName': 'Kristie B', 'Initials': 'KB', 'LastName': 'Hadden', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Highway, Shreveport, LA, 71130-3932, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Northwestern University, Division of General Internal Medicine and Geriatrics, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Highway, Shreveport, LA, 71130-3932, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gan', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Hur', 'Affiliation': 'Northwestern University, Division of General Internal Medicine and Geriatrics, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'McSweeney', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Brandie L', 'Initials': 'BL', 'LastName': 'Mikesell', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Northwestern University, Department of Preventive Medicine, 680 N. Lake Shore Drive, Chicago, IL, 60611, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100550'] 635,32024786,Menstrual health intervention and school attendance in Uganda (MENISCUS-2): a pilot intervention study.,"OBJECTIVES Achieving good menstrual health and hygiene (MHH) is a public health challenge and there is little evidence to inform interventions. The aim of this study was to pilot test an intervention to improve MHH and school attendance in Uganda, in preparation for a future cluster-randomised trial. DESIGN Longitudinal study with pre-post evaluation of a pilot intervention. SETTING Two secondary schools in Entebbe, Uganda. PARTICIPANTS Of the 473 eligible students in secondary 2 (S2) at baseline, 450 (95.1%; 232 girls and 218 boys) consented/assented. 369 students (188 girls; 81.0%; and 181 boys; 83.0%) participated in the endline survey. INTERVENTION The intervention comprised training teachers to improve delivery of government guidelines for puberty education, training in use of a menstrual kit and pain management, a drama skit, provision of analgesics and improvements to school water and sanitation hygiene facilities. PRIMARY AND SECONDARY OUTCOME MEASURES Feasibility and acceptability of delivering the intervention. Baseline and endline quantitative surveys were conducted, with qualitative interviews conducted at endline. School attendance was assessed using self-completed daily diaries among a nested cohort of 100 female students. RESULTS There were high levels of uptake of the individual and behavioural intervention components (puberty education, drama skit, menstrual hygiene management (MHM) kit and pain management). The proportion of girls reporting anxiety about next period decreased from 58.6% to 34.4%, and reported use of effective pain management increased from 76.4% to 91.4%. Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation. The diary data and qualitative data indicated a potential intervention impact on improving menstrual-related school absenteeism. CONCLUSIONS The pilot study showed that the multicomponent MHM intervention was acceptable and feasible to deliver, and potentially effective in improving menstruation knowledge and management. A cluster-randomised trial is needed to evaluate rigorously the intervention effects on MHM and school attendance. TRIAL REGISTRATION NUMBER NCT04064736; Pre-results.",2020,"Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation.","['Menstrual health intervention and school attendance in Uganda (MENISCUS-2', 'Of the 473 eligible students in secondary 2 (S2) at baseline, 450 (95.1%; 232 girls and 218 boys) consented/assented', '100 female students', 'Two secondary schools in Entebbe, Uganda', '369 students (188 girls; 81.0%; and 181 boys; 83.0%) participated in the endline survey']","['multicomponent MHM intervention', 'training teachers to improve delivery of government guidelines for puberty education, training in use of a menstrual kit and pain management, a drama skit, provision of analgesics and improvements to school water and sanitation hygiene facilities']","['School attendance', 'high levels of uptake of the individual and behavioural intervention components (puberty education, drama skit, menstrual hygiene management (MHM) kit and pain management', 'effective pain management', 'school toilet facilities', 'MHH and school attendance', 'proportion of girls reporting anxiety about next period', 'comfort managing menstruation']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C2315938', 'cui_str': 'Genus Meniscus'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0040364', 'cui_str': 'Lavatories'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}]",473.0,0.0450692,"Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kansiime', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hytti', 'Affiliation': 'WoMena Uganda, Kampala, Uganda.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Nalugya', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Nakuya', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Prossy', 'Initials': 'P', 'LastName': 'Namirembe', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Shamirah', 'Initials': 'S', 'LastName': 'Nakalema', 'Affiliation': 'WoMena Uganda, Kampala, Uganda.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Neema', 'Affiliation': 'College of Humanities and Social Science, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Tanton', 'Affiliation': 'Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Alezuyo', 'Affiliation': 'Palm Tree Academy Uganda, Kampala, Uganda.'}, {'ForeName': 'Saidat', 'Initials': 'S', 'LastName': 'Namuli Musoke', 'Affiliation': 'Uganda Virus Research Institute, Entebbe, Uganda.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Torondel', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Suzanna C', 'Initials': 'SC', 'LastName': 'Francis', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ross', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneve, Switzerland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Helen Anne', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK helen.weiss@lshtm.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-031182'] 636,32202313,Benefits of a transtheoretical model-based program on exercise adherence in older adults with knee osteoarthritis: A cluster randomized controlled trial.,"AIMS Benefits of a transtheoretical model-based exercise program on exercise adherence (primary outcome) and secondary outcomes (self-efficacy, decisional balance, knee osteoarthritis symptoms, and physical function) were assessed among older adults with knee osteoarthritis. DESIGN A two-arm, superiority, assessor-blinded, cluster randomized trial with randomization at the community level. METHODS Participants were recruited from 14 communities in Beijing between April - October 2018 (N = 189). The intervention was a 24-week transtheoretical model-based exercise program and the control group underwent a non-theory-based exercise program. Exercise adherence was collected every 4 weeks and secondary outcomes were measured at baseline, 12 weeks, and 24 weeks. An independent t test and repeated-measures ANOVA were the main statistical tests. RESULTS Most participants were women (92.5%), married (81.4%), with high-school education (36.0%), with both knees affected (50.3%), and did not make use of a walker (93.8%). There were no significant differences between groups in any of the outcome measures at baseline. Repeated-measures ANOVA indicated that there was a significant difference in the trend of adherence scores between the two groups from 0-24 weeks. The independent t test showed that scores in the intervention group were significantly better than in the control group at 16, 20, and 24 weeks. Improvements in the intervention group were also significantly greater in all secondary outcomes than in the control group. CONCLUSION A theory-based exercise program could improve exercise adherence, self-efficacy, decisional balance, knee osteoarthritis symptoms, and physical functioning in older adults with knee osteoarthritis. TRIAL REGISTRATION Chinese Clinical Trials Registry number ChiCTR1800015458. Registered 31 March 2018. IMPACT The 24-week theory-based exercise program could improve exercise adherence, self-efficacy, decisional balance, symptoms of knee osteoarthritis, and physical functioning in older adults with knee osteoarthritis. The theory-based exercise program could help older adults with knee osteoarthritis to improve their symptoms and knee function.",2020,"The independent t-test showed that scores in the intervention group were significantly better than in the control group at 16 weeks, 20 weeks and 24 weeks.","['Participants were recruited from 14 communities in Beijing between April and October 2018 (N = 189', 'older adults with knee osteoarthritis']","['transtheoretical model-based exercise program and the control group underwent a non-theory-based exercise program', 'transtheoretical model-based program', 'exercise program', 'transtheoretical model-based exercise program', 'theory-based exercise program']","['exercise adherence', 'Exercise adherence', 'exercise adherence, self-efficacy, decisional balance, symptoms of knee osteoarthritis and physical functioning', 'exercise adherence, self-efficacy, decisional balance, knee osteoarthritis symptoms and physical functioning', 'secondary outcomes (self-efficacy, decisional balance, knee osteoarthritis symptoms and physical function', 'adherence scores']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.061063,"The independent t-test showed that scores in the intervention group were significantly better than in the control group at 16 weeks, 20 weeks and 24 weeks.","[{'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Yunlin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Peking University Third Hospital, China, Beijing.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Recovery, Peking University Third Hospital, China, Beijing.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Qiaoqin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Jieru', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}, {'ForeName': 'Shaomei', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'School of Nursing, Peking University, China, Beijing.'}]",Journal of advanced nursing,['10.1111/jan.14363'] 637,32143644,Acceptability and appropriateness of a perinatal depression preventive group intervention: a qualitative analysis.,"BACKGROUND Perinatal depression is a prevalent public health concern. Although preventive interventions exist, there is limited literature on the acceptability and appropriateness of these interventions, especially those delivered by paraprofessionals. The Mothers and Babies Program (MB) is a group-based perinatal depression preventive intervention delivered prenatally. A cluster-randomized controlled trial examined the acceptability, appropriateness, and effectiveness of MB delivered by mental health professionals compared to paraprofessional staff from home visiting programs. METHODS The full study enrolled 874 pregnant women. Fifty-three facilitators were trained and delivered the MB intervention to women in one of seven states in the United States. Semi-structured interviews were attempted with a randomly-selected subset of the full sample of pregnant women who received the MB intervention and with all facilitators. Specifically, interviews were conducted with 88 women who received the MB group intervention (45 in the paraprofessional-led arm and 43 in the mental health professional-led arm) and 46 women who facilitated the groups (27 home visiting staff and 19 mental health professionals). Interviews were conducted over the phone in English or Spanish and audio recorded. The recordings were translated into English, as needed, and transcribed. Thematic analysis was conducted using NVIVO to identify key themes related to intervention acceptability and appropriateness. Similarities and differences between study arms were explored. RESULTS Clients and facilitators found the MB content and group format acceptable. Challenges included maintaining group attendance, transportation issues, and managing group discussion. Overall, facilitators found the intervention appropriate for pregnant clients with some challenges presented for clients in crisis situations, experiencing housing instability, and with literacy and learning challenges. Participants provided suggestions for improvement, both for the course content and implementation. There were no significant differences found between study arms. CONCLUSIONS Overall, clients and facilitators enjoyed MB irrespective of study arm, and facilitators found the intervention appropriate for the population. These findings add to the qualitative literature on perinatal depression preventive interventions, specifically those delivered by paraprofessionals. TRIAL REGISTRATION This trial is registered on ClinicalTrials.gov (Initial post: December 1, 2016; identifier: NCT02979444).",2020,"Overall, clients and facilitators enjoyed MB irrespective of study arm, and facilitators found the intervention appropriate for the population.","['874 pregnant women', 'pregnant clients', '88 women who received the MB group intervention (45 in the paraprofessional-led arm and 43 in the mental health professional-led arm) and 46 women who facilitated the groups (27 home visiting staff and 19 mental health professionals']","['perinatal depression preventive group intervention', 'MB intervention and with all facilitators', 'MB intervention']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],874.0,0.0531924,"Overall, clients and facilitators enjoyed MB irrespective of study arm, and facilitators found the intervention appropriate for the population.","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Diebold', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 643, Chicago, IL, 60611, USA. alicia.diebold@northwestern.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Segovia', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 680, Chicago, IL, 60611, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 680, Chicago, IL, 60611, USA.'}, {'ForeName': 'Aria', 'Initials': 'A', 'LastName': 'Degillio', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 680, Chicago, IL, 60611, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Zakieh', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 680, Chicago, IL, 60611, USA.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 680, Chicago, IL, 60611, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 680, Chicago, IL, 60611, USA.'}, {'ForeName': 'S Darius', 'Initials': 'SD', 'LastName': 'Tandon', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Suite 680, Chicago, IL, 60611, USA.'}]",BMC health services research,['10.1186/s12913-020-5031-z'] 638,31784988,Use of the Dyskinesia Impairment Scale in non-ambulatory dyskinetic cerebral palsy.,"AIM To assess the responsiveness, concurrent validity, and feasibility of the Dyskinesia Impairment Scale (DIS) in non-ambulatory patients with dyskinetic cerebral palsy (CP). METHOD The study is a secondary analysis of data collected in the IDYS trial, a randomized controlled trial on the effects of intrathecal baclofen (ITB). The DIS and Barry-Albright Dystonia Scale (BADS) were conducted at baseline and after 3 months of ITB or placebo treatment. Responsiveness was assessed by comparing the effect sizes and correlation of change after treatment between the DIS and BADS. Concurrent validity was evaluated by assessing the correlations between scales. Feasibility was evaluated for each DIS item by the number of participants who successfully accomplished the item. RESULTS Thirty-three non-ambulatory patients (9 females, 24 males) with dyskinetic CP (ITB-treated: n=17, mean [SD] age: 14y 1mo [4y 1mo]; placebo-treated: n=16, mean [SD] age: 14y 7mo [4y]) were included in the study. The effect sizes for BADS and DIS were similar in The ITB-treated group (-0.29 and -0.22 respectively). Changes after treatment on the DIS dystonia subscale correlated with changes on the BADS (r=0.64; p<0.001). The DIS dystonia subscale and BADS correlated at baseline and follow-up (r=0.78; p<0.001 and r=0.79; p<0.001). Not all DIS activity items could be performed in this sample of patients. INTERPRETATION For non-ambulatory patients with dyskinetic CP, the responsiveness of the DIS equalled the responsiveness of BADS. Concurrent validity was adequate. Feasibility for activity items was restricted in patients with severe dyskinetic CP. WHAT THIS PAPER ADDS The Dyskinesia Impairment Scale (DIS) and Barry-Albright Dystonia Scale showed similar responsiveness in non-ambulatory patients with dyskinetic cerebral palsy (CP). No floor or ceiling effect was observed for DIS in non-ambulatory participants. The concurrent validity of DIS was adequate in non-ambulatory participants. Patients with dyskinetic CP in Gross Motor Function Classification System levels IV and V could not perform all DIS activity items.",2020,Changes after treatment on the DIS dystonia subscale correlated with changes on the BADS (r=0.64; p<0.001).,"['non-ambulatory dyskinetic cerebral palsy', 'ambulatory patients with dyskinetic CP', 'patients with severe dyskinetic CP', 'Thirty-three non-ambulatory patients (9 females, 24 males) with dyskinetic CP (ITB-treated: n=17, mean [SD] age: 14y 1mo [4y 1mo]; placebo-treated: n=16, mean [SD] age: 14y 7mo [4y]) were included in the study', 'non-ambulatory patients with dyskinetic cerebral palsy (CP']","['intrathecal baclofen (ITB', 'placebo', 'Dyskinesia Impairment Scale (DIS']","['DIS and Barry-Albright Dystonia Scale (BADS', 'DIS dystonia subscale', 'Dyskinesia Impairment Scale', 'BADS and DIS', 'DIS dystonia subscale and BADS']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0270742', 'cui_str': 'Cerebral Palsy, Dyskinetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439842', 'cui_str': 'Dyskinetic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}]","[{'cui': 'C0013421', 'cui_str': 'Muscle Dystonia'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",33.0,0.0242173,Changes after treatment on the DIS dystonia subscale correlated with changes on the BADS (r=0.64; p<0.001).,"[{'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Haberfehlner', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Bonouvrié', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Boeschoten', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Fleuren', 'Affiliation': 'Department of Neurology, Section of Pediatric Neurology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Elegast', 'Initials': 'E', 'LastName': 'Monbaliu', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven Campus Brugge, Brugge, Belgium.'}, {'ForeName': 'Jules G', 'Initials': 'JG', 'LastName': 'Becher', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'R Jeroen', 'Initials': 'RJ', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Neurology, Section of Pediatric Neurology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Annemieke I', 'Initials': 'AI', 'LastName': 'Buizer', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14415'] 639,32192739,Reply to Comment on: Conbercept for Treatment of Neovascular Age-Related Macular Degeneration: Results of the Randomized Phase 3 PHOENIX Study.,,2020,,['Neovascular Age-Related Macular Degeneration'],['Conbercept'],[],"[{'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}]",[],,0.0180722,,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Shanghai, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Shanghai, China.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Kaiser', 'Affiliation': 'Cleveland, Ohio.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenfeld', 'Affiliation': 'Miami, Florida.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Boston, Massachusetts.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.007'] 640,32164612,Experiences and intentions of Ugandan household tuberculosis contacts receiving test results via text message: an exploratory study.,"BACKGROUND The World Health Organization (WHO) recommends household contact investigation for tuberculosis (TB) in high-burden countries. However, household contacts who complete evaluation for TB during contact investigation may have difficulty accessing their test results. Use of automated short-messaging services (SMS) to deliver test results could improve TB status awareness and linkage to care. We sought to explore how household contacts experience test results delivered via SMS, and how these experiences influence follow-up intentions. METHODS We conducted semi-structured interviews with household contacts who participated in a randomized controlled trial evaluating home sputum collection and delivery of TB results via SMS (Pan-African Clinical Trials Registry #201509000877140). We asked about feelings, beliefs, decisions, and behaviors in response to the SMS results. We analyzed the content and emerging themes in relation to the Theory of Planned Behavior. RESULTS We interviewed and achieved thematic saturation with ten household contacts. Nine received TB-negative results and one a TB-positive result. Household contacts reported relief upon receiving SMS confirming their TB status, but also said they lacked confidence in the results delivered by SMS. Some worried that negative results were incorrect until they spoke to a lay health worker (LHW). Household contacts said their long-term intentions to request help or seek care were influenced by perceived consequences of not observing the LHW's instructions related to the SMS and follow-up procedures; beliefs about the curability of TB; anticipated support from LHWs; and perceived barriers to responding to an SMS request for further evaluation. CONCLUSION Household contacts experienced relief when they received results. However, they were less confident about results delivered via SMS than results delivered by LHWs. Delivery of results by SMS should complement continued interaction with LHWs, not replace them.",2020,Use of automated short-messaging services (SMS) to deliver test results could improve TB status awareness and linkage to care.,[],['automated short-messaging services (SMS'],['TB status awareness and linkage to care'],[],"[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",,0.101313,Use of automated short-messaging services (SMS) to deliver test results could improve TB status awareness and linkage to care.,"[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Ggita', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Katahoire', 'Affiliation': 'Child Health and Development Centre, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Meyer', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nansubuga', 'Affiliation': 'Department of Population Studies, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Talemwa', 'Initials': 'T', 'LastName': 'Nalugwa', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Ochom', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ayakaka', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Global Health, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Armstrong-Hough', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda. mah842@nyu.edu.'}, {'ForeName': 'J Lucian', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}]",BMC public health,['10.1186/s12889-020-8427-0'] 641,30846313,Improving the Degree and Uniformity of Enhancement in Coronary CT Angiography with a New Bolus Tracking Method Enabled By Free Breathing.,"RATIONALE AND OBJECTIVES To demonstrate the improved enhancement degree and uniformity in coronary CT angiography (CCTA) on a 16 cm wide-coverage CT with a new bolus tracking method enabled by free-breathing, in comparison with the conventional breath-holding method. MATERIALS AND METHODS A total of 200 patients with suspected coronary heart disease were randomly divided into two groups for CCTA: Group A (n = 100, free-breathing) started CCTA with 2.2 seconds delay after the attenuation in aorta reached 250 HU; Group B (n = 100, breath-holding), used the standard protocol of 80 HU threshold and 8.4 seconds delay. Both groups used the contrast dose rate of 25 mgI/kg/s. CT value and standard deviation in aortic sinus (AS), right coronary artery, left anterior descending, left circumflex, and pericardial fat were measured. Contrast-to-noise ratio for vessels was calculated. Two experienced Radiologists independently reviewed image quality using a 5-point scale (1: nondiagnostic-5: excellent). RESULTS There was no difference in contrast dose, radiation dose, heart rate, and qualitative image quality between the two groups (all p > 0.05). However, Group A had higher mean enhancement in vessels (404 ± 66 HU) than Group B (321 ± 69 HU), and lower coefficients of variation of CT value in aortic sinus, right coronary artery, left anterior descending, and left circumflex (16.3%, 17.7%, 19.2%, and 20.5% vs 21.5%, 22.3%, 23.6%, and 22.9%, respectively), (all p < 0.05). CONCLUSION A new bolus tracking method enabled by free-breathing in CCTA on a 16 cm wide-coverage CT system increases the enhancement degree and uniformity in coronary arteries, compared with the conventional breath-holding method.",2019,"There was no difference in contrast dose, radiation dose, heart rate, and qualitative image quality between the two groups (all p > 0.05).",['200 patients with suspected coronary heart disease'],"['coronary CT angiography (CCTA', 'CCTA']","['contrast dose, radiation dose, heart rate, and qualitative image quality', 'variation of CT value in aortic sinus, right coronary artery, left anterior descending, and left circumflex', 'CT value and standard deviation in aortic sinus (AS), right coronary artery, left anterior descending, left circumflex, and pericardial fat']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037197', 'cui_str': 'Aortic Sinus'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0441998', 'cui_str': 'Left anterior (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0225971', 'cui_str': 'Pericardial fat (body structure)'}]",200.0,0.0152065,"There was no difference in contrast dose, radiation dose, heart rate, and qualitative image quality between the two groups (all p > 0.05).","[{'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': ""Department of Radiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, PR China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, PR China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'GE Healthcare, Computed Tomography Research Center, Beijing, PR China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, PR China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Qu', 'Affiliation': ""Department of Radiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, PR China.""}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, PR China.""}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': ""Department of Radiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, PR China.""}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, PR China. Electronic address: xjyjsz@163.com.""}]",Academic radiology,['10.1016/j.acra.2019.01.018'] 642,32191532,Evaluation of different antiandrogenic progestins on clinical and biochemical variables in polycystic ovary syndrome.,"Objectives: The aim of the study was to update the results of a previous study published 10 years ago and compare the effect on hyperandrogenism of a newer progestin, dienogest (DNG), in a combined oral contraceptive (COC) formulation with ethinylestradiol (EE), with that of COCs containing the same dose of EE in combination with drospirenone (DRSP) and chlormadinone acetate (CMA). Methods: Sixty women with polycystic ovary syndrome (PCOS) aged between 16 and 35 and requiring antiandrogenic contraceptive treatment were randomised to one of three treatment groups: EE 30 µg/DRSP 3 mg, EE 30 µg/CMA 2 mg, EE 30 µg/DNG 2 mg. We evaluated the effects of the three COCs on sex hormone-binding globulin (SHBG) and biochemical markers of hyperandrogenism. Results: After 3 months of treatment, serum androgen concentrations were significantly improved in all treatment groups. Serum concentrations of SHBG were significantly increased with all COC treatments ( p  < 0.0001). Interestingly, DRSP had a greater effect (+218%; p  < 0.0001) on serum SHBG concentrations compared with DNG and CMA ( p  < 0.04 and p  < 0.002, respectively). Serum concentrations of total testosterone significantly decreased in all groups ( p  < 0.0001). DRSP had a significantly greater effect on total testosterone concentrations compared with DNG ( p  = 0.002) and CMA ( p  < 0.0001). Conclusion: Our study showed that DNG exerted an important stimulatory effect on SHBG concentrations, which was less than that of DRSP but greater than that of CMA. Similar results were also obtained for dehydroepiandrosterone sulphate and total testosterone.",2020,DRSP had a significantly greater effect on total testosterone concentrations compared with DNG ( p  = 0.002) and CMA ( p  < 0.0001).,"['polycystic ovary syndrome', 'Sixty women with polycystic ovary syndrome (PCOS) aged between 16 and 35 and requiring antiandrogenic contraceptive treatment']","['drospirenone (DRSP) and chlormadinone acetate (CMA', 'oral contraceptive (COC) formulation with ethinylestradiol (EE', 'DNG', 'EE 30 µg/DRSP 3\u2009mg, EE 30 µg/CMA 2\u2009mg, EE 30 µg/DNG 2\u2009mg', 'antiandrogenic progestins', 'DRSP']","['total testosterone concentrations', 'serum androgen concentrations', 'SHBG concentrations', 'serum SHBG concentrations', 'Serum concentrations of SHBG', 'sex hormone-binding globulin (SHBG) and biochemical markers of hyperandrogenism', 'Serum concentrations of total testosterone', 'dehydroepiandrosterone sulphate and total testosterone']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0008214', 'cui_str': 'Chlormadinone Acetate'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenism'}, {'cui': 'C0057277', 'cui_str': 'Prasterone Sulfate'}]",60.0,0.0846395,DRSP had a significantly greater effect on total testosterone concentrations compared with DNG ( p  = 0.002) and CMA ( p  < 0.0001).,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Morgante', 'Affiliation': 'Section of Obstetrics and Gynaecology, Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cappelli', 'Affiliation': 'Section of Obstetrics and Gynaecology, Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Libera', 'Initials': 'L', 'LastName': 'Troìa', 'Affiliation': 'Section of Obstetrics and Gynaecology, Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'De Leo', 'Affiliation': 'Section of Obstetrics and Gynaecology, Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2020.1736546'] 643,32190806,Effects of Semaglutide Versus Dulaglutide on Epicardial Fat Thickness in Subjects with Type 2 Diabetes and Obesity.,"Background and Aims Epicardial adipose tissue (EAT), the visceral fat depot of the heart, is a modifiable cardio-metbolic risk factor and therapeutic target. Semaglutide and dulaglutide, glucagon-like peptide-1 (GLP-1) receptor agonists, are indicated for the treatment of type 2 diabetes mellitus (T2DM). GLP-1 receptor agonists have recently shown to reduce cardiovascular risk. Epicardial adipose tissue expresses GLP-1 receptors (GLP-1Rs). GLP-1 receptor agonist liraglutide is known to significantly decrease EAT thickness. However, the effects of GLP-1 receptor agonists semaglutide and dulaglutide on EAT thickness are unknown. Materials and Methods We performed a 12-week, controlled, parallel study in 80 subjects with T2DM and obesity. Patients received either semaglutide, up to 1 mg subcutaneous (sc) weekly, or dulaglutide, up to 1.5 mg sc weekly, as the standard of care in addition to their usual medication regimen. Twenty subjects with T2DM and obesity were started on metformin and a diet and served as the control group. Ultrasound-measured EAT thickness was measured at baseline and at the 12-week follow-up. Results Epicardial adipose tissue thickness significantly decreased in both semaglutide and dulaglutide groups ( P  < 0.001) after 12 weeks, accounting for a 20% reduction. There was no EAT reduction in the metformin group. Body mass index (BMI) and HbA1c improved in all groups without reaching statistical significance. Epicardial adipose tissue thickness reduction was significantly greater ( P  < 0.01) with the higher doses of semaglutide (1 mg) and dulaglutide (1.5 mg), respectively. Conclusion Weekly administration of either GLP-1 receptor agonists semaglutide or dulaglutide causes a rapid, substantial, and dose-dependent reduction in EAT thickness.",2020,"Epicardial adipose tissue thickness reduction was significantly greater ( P  < 0.01) with the higher doses of semaglutide (1 mg) and dulaglutide (1.5 mg), respectively. ","['Subjects with Type 2 Diabetes and Obesity', 'Twenty subjects with T2DM and obesity were started on', '80 subjects with T2DM and obesity', 'type 2 diabetes mellitus (T2DM']","['GLP-1 receptor agonist liraglutide', 'Semaglutide Versus Dulaglutide', 'metformin', 'semaglutide', 'Semaglutide and dulaglutide, glucagon-like peptide-1 (GLP-1) receptor agonists']","['EAT reduction', 'Epicardial adipose tissue thickness reduction', 'Ultrasound-measured EAT thickness', 'Epicardial adipose tissue thickness', 'Body mass index (BMI) and HbA1c', 'Epicardial Fat Thickness', 'cardiovascular risk', 'EAT thickness']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",80.0,0.0114572,"Epicardial adipose tissue thickness reduction was significantly greater ( P  < 0.01) with the higher doses of semaglutide (1 mg) and dulaglutide (1.5 mg), respectively. ","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Villasante Fricke', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvz042'] 644,31809409,Energy Deficit Required for Exercise-induced Improvements in Glycemia the Next Day.,"PURPOSE This study determined the impact of an exercise-induced energy deficit on postprandial and 24 h glycemic control the day after a session of exercise. METHODS Fifteen healthy participants (m/f = 5/10, 27 ± 6 yr, body mass index = 24 ± 3 kg·m, peak oxygen consumption [V˙O2peak] = 36 ± 9 mL·kg·min) completed two separate 5-d experimental trials performed under ""free-living"" conditions. On day 1 of each trial, participants were fitted with a continuous glucose monitor and abstained from exercise. Day 2 served as a nonexercise control (NoEx). On day 3, participants exercised at 3:00 PM (65% V˙O2peak) until they expended 350 kcals (~45 min). The diet during both experimental trials was identical with the exception of meals after this exercise session. During one trial, the dinner after exercise did not replenish the 350 kcal expended during exercise, thereby establishing an exercise energy deficit (ExDEF). During the other experimental trial, the dinner after exercise contained an additional 350 kcal to compensate for the energy expended during exercise, and thereby maintained energy balance after exercise (ExBAL). Free-living glycemia was measured the day before exercise (NoEx) and the day after exercise under ExDEF and ExBAL conditions. RESULTS The day after exercise, 3 h postprandial area under the curve was lower after breakfast in ExDEF compared with ExBAL (16.0 ± 1.8 vs 17.0 ± 1.6 mmol·L·h per 3 h, P = 0.01), but did not differ between groups after lunch (P = 0.24), dinner (P = 0.39), or evening snack (P = 0.45). Despite differences in the glycemic response to breakfast, 24 h glycemia did not differ between ExDEF and ExBAL (area under the curve = 128 ± 10 vs 131 ± 10 mmol·L·h per 24 h, respectively; P = 0.54). CONCLUSIONS An exercise-induced energy deficit lowered the glycemic response to breakfast the next day-but this energy deficit did not impact total 24 h glycemia, the day after exercise in metabolically healthy adults.",2020,An exercise-induced energy deficit lowered the glycemic response to breakfast the next day - but this energy deficit did not impact total 24h glycemia the day after exercise in metabolically healthy adults.,"['metabolically healthy adults', 'Fifteen healthy participants (m/f=5/10, 27±6 yrs, BMI=24±3 kg·m, VO2peak=36±9 mL·kg·min) completed two separate 5-day experimental trials performed under ""free-living"" conditions']","['exercise-induced energy deficit', 'Day 2 served as a non-exercise control (NoEx', 'dinner after exercise did not replenish the 350 kcals expended during exercise, thereby establishing an exercise energy deficit (ExDEF', 'continuous glucose monitor (CGM) and abstained from exercise']","['postprandial area under curve (AUC', 'Free-living glycemia', 'glycemic response to breakfast, 24h glycemia']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]",15.0,0.0604915,An exercise-induced energy deficit lowered the glycemic response to breakfast the next day - but this energy deficit did not impact total 24h glycemia the day after exercise in metabolically healthy adults.,"[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Schleh', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Horowitz', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, MI.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002211'] 645,31838450,Cognitive and language performance predicts effects of spelling intervention and tDCS in Primary Progressive Aphasia.,"Predictors of treatment effects allow individual tailoring of treatment characteristics, thereby saving resources and optimizing outcomes. Electrical stimulation coupled with language intervention has shown promising results in improving language performance in individuals with Primary Progressive Aphasia (PPA). The current study aimed to identify language and cognitive variables associated with response to therapy consisting of language intervention combined with transcranial direct current stimulation (tDCS). Forty individuals with PPA received written naming/spelling intervention combined with anodal tDCS or Sham, using a between-subjects, randomized design, with intervention delivered over a period of 3 weeks. Participants were assessed using a battery of neuropsychological tests before and after each phase. We measured letter accuracy during spelling of trained and untrained words, before, immediately after, 2 weeks, and 2 months after therapy. We used step-wise regression methods to identify variables amongst the neuropsychological measures and experimental factors that were significantly associated with therapy outcomes at each time-point. For trained words, improvement was related to pre-therapy scores, in RAVLT (5 trials sum), pseudoword spelling, object naming, digit span backward, spatial span backward and years post symptom onset. Regarding generalization to untrained words, improvement in spelling was associated with pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall. Generalization effects were larger under tDCS compared to Sham at the 2-month post training measurement. We conclude that, for trained words, patients who improve the most are those who retain for longer language skills such as sublexical spelling processes (phoneme-to-grapheme correspondences) and word retrieval, and other cognitive functions such as executive functions and working memory, and those who have a better learning capacity. Generalization to untrained words occurs through improvement in knowledge of phoneme-to-grapheme correspondences. Furthermore, tDCS enhances the generalizability and duration of therapy effects.",2020,"Regarding generalization to untrained words, improvement in spelling was associated with pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall.","['Primary Progressive Aphasia', 'Forty individuals with PPA received', 'individuals with Primary Progressive Aphasia (PPA']","['spelling intervention and tDCS', 'language intervention combined with transcranial direct current stimulation (tDCS', 'written naming/spelling intervention combined with anodal tDCS', 'Electrical stimulation coupled with language intervention']","['generalizability and duration of therapy effects', 'language performance', 'pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall', 'Generalization effects', 'pseudoword spelling, object naming, digit span backward, spatial span backward and years post symptom onset']","[{'cui': 'C0282513', 'cui_str': 'Mesulam Syndrome'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0331515', 'cui_str': 'Triticum spelta'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",40.0,0.0733283,"Regarding generalization to untrained words, improvement in spelling was associated with pseudoword spelling, RAVLT proactive interference, RAVLT immediate recall.","[{'ForeName': 'Vânia', 'Initials': 'V', 'LastName': 'de Aguiar', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Centre for Language and Cognition Groningen (CLCG), University of Groningen. Electronic address: vania.de.aguiar@rug.nl.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health.'}, {'ForeName': 'Bronte N', 'Initials': 'BN', 'LastName': 'Ficek', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Webster', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Department of Otolaryngology, Johns Hopkins Medicine.'}, {'ForeName': 'Adrià', 'Initials': 'A', 'LastName': 'Rofes', 'Affiliation': 'Centre for Language and Cognition Groningen (CLCG), University of Groningen; Global Brain Health Institute, Trinity College Dublin, Dublin, Ireland; Department of Cognitive Science, Johns Hopkins University.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Wendt', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Caffo', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health.'}, {'ForeName': 'Argye E', 'Initials': 'AE', 'LastName': 'Hillis', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Department of Cognitive Science, Johns Hopkins University; Department of Physical Medicine & Rehabilitation, Johns Hopkins University.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Rapp', 'Affiliation': 'Department of Cognitive Science, Johns Hopkins University.'}, {'ForeName': 'Kyrana', 'Initials': 'K', 'LastName': 'Tsapkini', 'Affiliation': 'Department of Neurology, Johns Hopkins Medicine; Department of Cognitive Science, Johns Hopkins University.'}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2019.11.001'] 646,31995811,Nicotine dependence (trait) and acute nicotinic stimulation (state) modulate attention but not inhibitory control: converging fMRI evidence from Go-Nogo and Flanker tasks.,"Cognitive deficits during nicotine withdrawal may contribute to smoking relapse. However, interacting effects of chronic nicotine dependence and acute nicotine withdrawal on cognitive control are poorly understood. Here we examine the effects of nicotine dependence (trait; smokers (n = 24) vs. non-smoking controls; n = 20) and acute nicotinic stimulation (state; administration of nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning. We compared performance and neural responses between these four pharmacological manipulations in a double-blind, placebo-controlled crossover design. As expected, performance in both tasks was modulated by nicotine dependence, abstinence, and pharmacological manipulation. However, effects were driven entirely by conditions that required less inhibitory control. When demand for inhibitory control was high, abstinent smokers showed no deficits. By contrast, acutely abstinent smokers showed performance deficits in easier conditions and missed more trials. Go-Nogo fMRI results showed decreased inhibition-related neural activity in right anterior insula and right putamen in smokers and decreased dorsal anterior cingulate cortex activity on nicotine across groups. No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task. Given robust nicotinic effects on physiology and behavioral deficits in attention, we are confident that pharmacological manipulations were effective. Thus findings fit a recent proposal that abstinent smokers show decreased ability to divert cognitive resources at low or intermediate cognitive demand, while performance at high cognitive demand remains relatively unaffected, suggesting a primary attentional deficit during acute abstinence.",2020,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,['trait; smokers (n\u2009=\u200924) vs. non-smoking controls; n\u2009=\u200920) and acute nicotinic stimulation (state; administration of'],"['nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning', 'nicotine dependence', 'placebo', 'Nicotine dependence (trait) and acute nicotinic stimulation (state']","['dorsal anterior cingulate cortex activity', 'inhibition-related neural activity', 'performance deficits', 'Cognitive deficits', 'inhibition-related activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0240423,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lesage', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Sutherland', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Salmeron', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Estein@nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0623-1'] 647,31785588,Increased subjective and reinforcing effects of initial nicotine exposure in young adults with attention deficit hyperactivity disorder (ADHD) compared to matched peers: results from an experimental model of first-time tobacco use.,"Individuals with attention deficit hyperactivity disorder (ADHD) are at increased risk for adverse cigarette smoking outcomes, and little is known about factors underlying this risk. This study sought to evaluate the effects of initial nicotine exposure in young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences. Participants were young adult nonsmokers (n = 61 ADHD, n = 75 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years. Participants were exposed to three different blinded doses of intranasally administered nicotine (0, 0.5, 1.0 mg) across three separate fixed dose experimental sessions. In subsequent sessions, participants were given the opportunity to self-administer nicotine under two different conditions-high and low cognitive demand. Physiological, subjective, and reinforcing effects of nicotine were the main outcomes. Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups. ADHD participants reported significantly greater dizziness following nicotine, and greater pleasant subjective effects across all conditions, compared to non-ADHD non-smokers. There were no group differences on subjective reports of bad or unpleasant effects. Subsequent nicotine self-administration was significantly higher among non-smokers with ADHD, and their choices of nicotine were not influenced by cognitive condition. There are meaningful differences between young adults with and without ADHD with respect to the initial subjective and reinforcing effects of nicotine; and interventions to prevent use should start prior to typical age of experimentation among ADHD patients.",2020,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","['young adults with attention deficit hyperactivity disorder (ADHD', 'Participants were young adult nonsmokers (n\u2009=\u200961 ADHD, n\u2009=\u200975 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years', 'Individuals with attention deficit hyperactivity disorder (ADHD', 'young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences']","['initial nicotine exposure', 'nicotine']","['Nicotine plasma levels', 'subjective reports of bad or unpleasant effects', 'pleasant subjective effects', 'dizziness', 'heart rate or blood pressure']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",61.0,0.016876,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","[{'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kollins', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. scott.kollins@duke.edu.'}, {'ForeName': 'Maggie M', 'Initials': 'MM', 'LastName': 'Sweitzer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Departments of Psychiatry, Psychology, and Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0581-7'] 648,32187115,Factors Associated With Cannabis Use Among African American Nondaily Smokers.,"OBJECTIVES Cannabis and tobacco dual use is a growing concern in the United States, especially among African Americans (AAs). Dual use increases nicotine dependence and poses negative health effects. Despite decreasing numbers of people who smoke daily, nondaily smokers (NDS) are increasing. Polytobacco use, including blunt use, is higher in AA NDS than AAs who smoke daily. This study examined factors associated with cannabis use among AA NDS. METHODS Adult AA NDS participated in a randomized controlled trial (n = 278) for smoking cessation. A subset of this sample (n = 262; mean age 48.2 years; 50% male) was analyzed to identify correlates of cannabis use. Logistic regression assessed the associations of demographic, smoking-related, and psychosocial variables with cannabis use. RESULTS Participants smoked cigarettes on an average of 18 days of the last 30 and used 4.5 cigarettes on smoking days. Of the participants analyzed, 38% used cannabis, including blunts (ie, cigars hollowed out filled with cannabis) at baseline. Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004). CONCLUSIONS Rates of cannabis and tobacco dual use in our sample exceed national rates. Dual use poses harmful health effects that exceed the risk of either substance alone. Findings will inform future work in tailoring treatments to vulnerable groups of people who use both tobacco and cannabis.",2020,"Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004). ","['African Americans (AAs', 'African American Nondaily Smokers', 'Adult AA NDS participated in a randomized controlled trial (n\u200a=\u200a278) for smoking cessation', 'A subset of this sample (n\u200a=\u200a262; mean age 48.2 years; 50% male']",[],['depressive symptoms'],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0057753', 'cui_str': 'NDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0939808,"Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004). ","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rubenstein', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI (DR, ERA, JSA); Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI (ERA, JSA); Department of Population Health, University of Kansas School of Medicine, Kansas City, KS (NLN); Department of Biostatistics & Data Science, University of Kansas School of Medicine, Kansas City, KS (MSM, ARB).'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Aston', 'Affiliation': ''}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': ''}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': ''}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000652'] 649,32186326,Long-term dietary intervention reveals resilience of the gut microbiota despite changes in diet and weight.,"BACKGROUND With the rising rates of obesity and associated metabolic disorders, there is a growing need for effective long-term weight-loss strategies, coupled with an understanding of how they interface with human physiology. Interest is growing in the potential role of gut microbes as they pertain to responses to different weight-loss diets; however, the ways that diet, the gut microbiota, and long-term weight loss influence one another is not well understood. OBJECTIVES Our primary objective was to determine if baseline microbiota composition or diversity was associated with weight-loss success. A secondary objective was to track the longitudinal associations of changes to lower-carbohydrate or lower-fat diets and concomitant weight loss with the composition and diversity of the gut microbiota. METHODS We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet. RESULTS While baseline microbiota composition was not predictive of weight loss, each diet resulted in substantial changes in the microbiota 3-mo after the start of the intervention; some of these changes were diet specific (14 taxonomic changes specific to the healthy low-carbohydrate diet, 12 taxonomic changes specific to the healthy low-fat diet) and others tracked with weight loss (7 taxonomic changes in both diets). After these initial shifts, the microbiota returned near its original baseline state for the remainder of the intervention, despite participants maintaining their diet and weight loss for the entire study. CONCLUSIONS These results suggest a resilience to perturbation of the microbiota's starting profile. When considering the established contribution of obesity-associated microbiotas to weight gain in animal models, microbiota resilience may need to be overcome for long-term alterations to human physiology. This trial was registered at clinicaltrials.gov as NCT01826591.",2020,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet. ",['49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet'],[],['weight loss'],"[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",49.0,0.0217248,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet. ","[{'ForeName': 'Gabriela K', 'Initials': 'GK', 'LastName': 'Fragiadakis', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Wastyk', 'Affiliation': 'Department of Bioengineering, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Robinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa046'] 650,31765604,Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial.,"Rationale: Oral treprostinil improves exercise capacity in patients with pulmonary arterial hypertension (PAH), but the effect on clinical outcomes was unknown. Objectives: To evaluate the effect of oral treprostinil compared with placebo on time to first adjudicated clinical worsening event in participants with PAH who recently began approved oral monotherapy. Methods: In this event-driven, double-blind study, we randomly allocated 690 participants (1:1 ratio) with PAH to receive placebo or oral treprostinil extended-release tablets three times daily. Eligible participants were using approved oral monotherapy for over 30 days before randomization and had a 6-minute-walk distance 150 m or greater. The primary endpoint was the time to first adjudicated clinical worsening event: death; hospitalization due to worsening PAH; initiation of inhaled or parenteral prostacyclin therapy; disease progression; or unsatisfactory long-term clinical response. Measurements and Main Results: Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio, 0.74; 95% confidence interval, 0.56-0.97; P  = 0.028). Key measures of disease status, including functional class, Borg dyspnea score, and N-terminal pro-brain natriuretic peptide, all favored oral treprostinil treatment at Week 24 and beyond. A noninvasive risk stratification analysis demonstrated that oral treprostinil-assigned participants had a substantially higher mortality risk at baseline but achieved a lower risk profile from Study Weeks 12-60. The most common adverse events in the oral treprostinil group were headache, diarrhea, flushing, nausea, and vomiting. Conclusions: In participants with PAH, addition of oral treprostinil to approved oral monotherapy reduced the risk of clinical worsening.Clinical trial registered with www.clinicaltrials.gov (NCT01560624).",2020,"RESULTS Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio 0.74; 95% confidence interval [CI], 0.56 to 0.97;","['690 participants (1:1 ratio) with PAH to receive', 'participants with PAH who recently began approved oral monotherapy', 'Pulmonary Arterial Hypertension', 'patients with pulmonary arterial hypertension (PAH', 'Eligible participants were using approved oral monotherapy for >30 days prior to randomization and had a 6-minute walk distance ≥150 m']","['Placebo', 'placebo or oral treprostinil', 'treprostinil', 'Oral Treprostinil', 'placebo', 'oral treprostinil']","['risk of clinical worsening', 'time to first adjudicated clinical worsening event: death, hospitalization due to worsening PAH, initiation of inhaled or parenteral prostacyclin therapy, disease progression, or unsatisfactory long-term clinical response', 'Clinical worsening', 'exercise capacity', 'disease status, including functional class, Borg dyspnea score, and N-terminal-pro-brain natriuretic peptide', 'headache, diarrhea, flushing, nausea, and vomiting', 'mortality risk']","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1145760', 'cui_str': 'Treprostinil'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0205911', 'cui_str': 'Prostaglandins I'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",690.0,0.763053,"RESULTS Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio 0.74; 95% confidence interval [CI], 0.56 to 0.97;","[{'ForeName': 'R James', 'Initials': 'RJ', 'LastName': 'White', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and the Mary M. Parkes Center, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Jerjes-Sanchez', 'Affiliation': 'Unidad de Investigación Clínica en Medicina, Monterrey, Mexico.'}, {'ForeName': 'Gisela Martina', 'Initials': 'GM', 'LastName': 'Bohns Meyer', 'Affiliation': 'Complexo Hospitalar Santa Casa de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Pulido', 'Affiliation': 'Departamento de Cardioneumología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Sepulveda', 'Affiliation': 'Pontifica Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Kuo Yang', 'Initials': 'KY', 'LastName': 'Wang', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Grünig', 'Affiliation': 'Thoraxclinic at University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Hiremath', 'Affiliation': 'Ruby Hall Clinic, Grant Medical Foundation, Pune, India.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Gangcheng', 'Affiliation': 'Wuhan Asia Heart Hospital, Wuhan Shi, China.'}, {'ForeName': 'Wei Luen James', 'Initials': 'WLJ', 'LastName': 'Yip', 'Affiliation': 'Department of Cardiology, National University Heart Centre, Singapore, Singapore.'}, {'ForeName': 'Shuyang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'C Q', 'Initials': 'CQ', 'LastName': 'Deng', 'Affiliation': 'United Therapeutics, Research Triangle Park, North Carolina; and.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Grover', 'Affiliation': 'United Therapeutics, Research Triangle Park, North Carolina; and.'}, {'ForeName': 'Victor F', 'Initials': 'VF', 'LastName': 'Tapson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1640OC'] 651,31896118,"Effects of intranasal insulin as an enhancer of fear extinction: a randomized, double-blind, placebo-controlled experimental study.","Fear-extinction based psychotherapy (exposure) is the most effective method for treating anxiety disorders. Notwithstanding, since some patients show impairments in the unlearning of fear and insufficient fear remission, there is a growing interest in using cognitive enhancers as adjuvants to exposure. As insulin plays a critical role in stress processes and acts as a memory enhancer, this study aimed to assess the capacity of intranasal insulin to augment fear extinction. A double-blind, placebo-controlled differential fear-conditioning paradigm was conducted in 123 healthy participants (63 females). Pictures of faces with neutral expressions were used as conditioned stimuli and electric shocks as unconditioned stimuli. The paradigm consisted of four phases presented on three consecutive days: acquisition (day 1), extinction (day 2), reinstatement and re-extinction (day 3). A single intranasal dose of insulin (160 IU) or placebo was applied on day 2, 45 min before fear extinction. Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings were assessed. During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group. Furthermore, a sex-specific effect was found for SCR, with women in the insulin group showing a greater decrease of differential SCR both at early extinction and at late re-extinction. Our results provide first evidence that intranasal insulin facilitates fear extinction processes and is therefore a promising adjuvant for extinction-based therapies in anxiety and related disorders. Sex-specific effects should be taken into consideration in future studies.",2020,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.",['123 healthy participants (63 females'],"['placebo-controlled differential fear-conditioning paradigm', 'insulin', 'intranasal insulin', 'Fear-extinction based psychotherapy (exposure', 'placebo']","['differential FPS', 'Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings', 'enhancer of fear extinction', 'differential SCR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",123.0,0.138692,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.","[{'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Ferreira de Sá', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany. diana.ferreira@uni-saarland.de.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Römer', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Brückner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Issler', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hauck', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0593-3'] 652,30772827,Adolescent males' responses to blu's fake warnings.,"OBJECTIVE Blu's 'Something Better' advertising campaign ran in popular print magazines in 2017. The campaign included advertisements with fake warnings conveying positive messages, which mimicked the Food and Drug Administration (FDA)'s warning requirements for electronic cigarette (e-cigarette) advertisements that took effect in 2018. We report adolescent males' recall of these fake warnings and how exposure to fake warnings affected recall of other advertisement components, including the actual warning or health risks, brand and product. METHODS Ohio males ages 12-19 years (N = 775; 73.8 % white non-Hispanic) were randomly assigned to view an e-cigarette advertisement with or without a fake warning. Afterward, they were asked what they remembered most about the advertisement. Responses were qualitatively coded. Statistical analyses included survey-weighted descriptive statistics and logistic regression. RESULTS Of participants who viewed an e-cigarette advertisement with a fake warning, 27.0 % reported the fake warning was what they remembered most, and 18.8 % repeated the fake warning message. Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements. CONCLUSIONS Adolescents viewing an advertisement with a fake warning were less likely to recall the advertisement's actual warning or health risks. Although e-cigarette advertisements now carry large FDA-mandated warnings, this tactic could be used for cigarette advertisements that continue to carry small warnings in the USA. Findings underscore the necessity of tobacco advertisement surveillance and study of advertisements' effects on adolescents.",2019,"Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements. ","['adolescents', 'Ohio males ages 12-19 years (N = 775; 73.8 % white non-Hispanic']",['view an e-cigarette advertisement with or without a fake warning'],"['actual warning or health risks', 'fake warning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0241441,"Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements. ","[{'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Keller-Hamilton', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio, USA keller-hamilton.1@osu.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Roberts', 'Affiliation': 'Division of Health Behavior and Health Promotion, College of Public Health, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Slater', 'Affiliation': 'School of Communication, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'Division of Health Services Management and Policy, College of Public Health, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Ferketich', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054805'] 653,32077404,Effects of a kindergarten intervention on vegetables served and staff's food-related practices: results of a cluster randomised controlled trial - the BRA study.,"OBJECTIVE The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff's food-related practices in the multicomponent BRA intervention. DESIGN Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff's food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff's food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department. SETTING The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway. PARTICIPANTS A total of seventy-three kindergartens participated. RESULTS At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff's food-related practices were found. CONCLUSIONS The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff's food-related practices.",2020,"No effects on the frequency of vegetables served or on staff's food-related practices were found. ","[""vegetables served and staff's food-related practices"", 'A total of seventy-three kindergartens participated', 'The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway']","[""questionnaire for kindergarten assistants assessing staff's food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department"", 'kindergarten intervention', 'BRA intervention']","[""frequency of vegetables served or on staff's food-related practices""]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0453881', 'cui_str': 'Brassiere (physical object)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",73.0,0.0474356,"No effects on the frequency of vegetables served or on staff's food-related practices were found. ","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Himberg-Sundet', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Anne Lene', 'Initials': 'AL', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Frost Andersen', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bjelland', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Lien', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980019003963'] 654,32184050,Tracking the Nonenrolled: Lung Cancer Screening Patterns Among Individuals not Accrued to a Clinical Trial.,"INTRODUCTION For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial. PATIENTS AND METHODS From February 2017 through February 2019, we enrolled subjects in a trial examining telephone-based navigation during low-dose computed tomography (LDCT) for lung cancer screening. We identified patients for whom LDCT was ordered and who were approached, but not enrolled, in the trial. We categorized nonenrollment as the patient had declined or could not be reached. We compared the characteristics and LDCT completion rates among these groups and the enrolled population using the 2-sample t test and χ 2 test. RESULTS Of 900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial. No significant demographic differences were found between the enrolled and nonenrolled cohorts. Of the 453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite up to 6 attempts. LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P < .001). CONCLUSIONS In the present single-center study, demographic factors did not predict for participation in a lung cancer screening trial. Lung cancer screening adherence rates were substantially lower for those not enrolled in a screening trial, especially for those who could not be contacted. These findings may inform the broader implementation of screening programs.",2020,"LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P ","['900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial', '453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite\xa0up to 6 attempts', 'lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial', 'From February 2017 through February 2019', 'Individuals']",['telephone-based navigation during low-dose computed tomography (LDCT'],"['characteristics and LDCT completion rates', 'Lung cancer screening adherence rates', 'LDCT completion']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]",447.0,0.104894,"LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P ","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: david.gerber@utsouthwestern.edu.'}, {'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Hamann', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, AZ; Department of Family and Community Medicine, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Chavez', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Dorsey', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Browning', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Cristhiaan D', 'Initials': 'CD', 'LastName': 'Ochoa', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Adesina', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Vijaya Subbu', 'Initials': 'VS', 'LastName': 'Natchimuthu', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Steen', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Division of General Internal Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Simon J Craddock', 'Initials': 'SJC', 'LastName': 'Lee', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.02.010'] 655,31647382,A randomized-control trial testing the impact of a multidisciplinary team response to older adult maltreatment.,"Forensic center multidisciplinary teams (MDTs) have emerged to address older adult maltreatment; however, little research is available on this approach. The current study employed a randomized-control design to test the impact of a victim-focused, forensic center MDT relative to usual care (UC) on older adult victim and criminal justice outcomes. Cases of abuse, neglect, and/or financial exploitation involving a perpetrator in a position of trust were randomly assigned to MDT or UC. Outcomes were assessed via interviews with older adult victims, system-based advocates' surveys, and administrative data. According to system-based advocates, MDT had a better prognosis, higher across-agency coordination, and more types of engaged services relative to UC. Administrative data indicated low rates of APS case openings and prosecution. Findings provide support for continued use of MDTs following older adult maltreatment and highlight difficulties engaging older adults given the complex social and material circumstances often related to maltreatment.",2019,"According to system-based advocates, MDT had a better prognosis, higher across-agency coordination, and more types of engaged services relative to UC.","['older adult victim and criminal justice outcomes', 'older adult maltreatment']","['victim-focused, forensic center MDT relative to usual care (UC']","[""older adult victims, system-based advocates' surveys, and administrative data""]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0589784,"According to system-based advocates, MDT had a better prognosis, higher across-agency coordination, and more types of engaged services relative to UC.","[{'ForeName': 'Anne P', 'Initials': 'AP', 'LastName': 'DePrince', 'Affiliation': 'Department of Psychology, University of Denver, Denver, Colorado, USA.'}, {'ForeName': 'Leslie K', 'Initials': 'LK', 'LastName': 'Hasche', 'Affiliation': 'Department of Psychology, University of Denver, Denver, Colorado, USA.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Olomi', 'Affiliation': 'Department of Psychology, University of Denver, Denver, Colorado, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Wright', 'Affiliation': 'Department of Psychology, University of Denver, Denver, Colorado, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Labus', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, Vatche and Tamar Manoukian Division of Digestive Diseases, University of California Los Angeles, Los Angeles, California, USA.'}]",Journal of elder abuse & neglect,['10.1080/08946566.2019.1682097'] 656,30948522,Greater analgesic effect with intermittent compared with continuous mode of lumbar plexus block for total hip arthroplasty: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES Lumbar plexus block (LPB) is an effective perioperative analgesic therapy for patients undergoing total hip arthroplasty (THA). However, the analgesic efficacy of intermittent administration compared with continuous infusion of LPB in patients remains unclear. METHODS Forty adult patients who underwent THA were randomly divided into two groups: continuous infusion group (6 mL/hour continuous infusion of levobupivacaine [0.125%] in LPB, n=20) and intermittent infusion group (12 mL of levobupivacaine [0.125%] bolus delivered every 2 hours in LPB, n=20). The primary outcome was the cumulative fentanyl consumption administered for rescue analgesia during the first 48 hours after surgery. Secondary outcomes were the number of demands for rescue analgesia and successfully delivered rescue analgesia; extent of sensory blockade (cold tests); and pain score on the visual analog scale (VAS) at rest and during mobilization during the first 48 hours after surgery. RESULTS Both the cumulative fentanyl consumption administered for rescue analgesia (mean [SD]: 81.5 [58.5] μg vs 438 [101.2] μg among the intermittent infusion and the continuous infusion groups, respectively) and the number of demanded and delivered fentanyl boluses for rescue analgesia were lower in intermittent infusion group than in continuous infusion (p<0.001 for both). The extent of sensory blockade remained constant in intermittent infusion group, but gradually narrowed in continuous infusion. VAS was lower in intermittent infusion group than in continuous infusion, except at 1 and 12 hours postoperatively (p<0.05). CONCLUSIONS Greater analgesic effect was achieved using the intermittent mode than the continuous mode of LPB administration.",2019,"VAS was lower in intermittent infusion group than in continuous infusion, except at 1 and 12 hours postoperatively (p<0.05). ","['Forty adult patients who underwent THA', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty', 'rescue analgesia (mean [SD']","['lumbar plexus block', 'levobupivacaine [0.125%] bolus delivered every 2\u2009hours in LPB', 'continuous infusion group (6\u2009mL/hour continuous infusion of levobupivacaine [0.125%] in LPB', 'Lumbar plexus block (LPB']","['analgesic efficacy', 'analgesic effect', 'number of demands for rescue analgesia and successfully delivered rescue analgesia; extent of sensory blockade (cold tests); and pain score on the visual analog scale (VAS) at rest and during mobilization', 'VAS', 'number of demanded and delivered fentanyl boluses for rescue analgesia', 'cumulative fentanyl consumption administered for rescue analgesia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0394731', 'cui_str': 'Lumbar plexus block (procedure)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]",40.0,0.12891,"VAS was lower in intermittent infusion group than in continuous infusion, except at 1 and 12 hours postoperatively (p<0.05). ","[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Ueshima', 'Affiliation': 'Anesthesiology, Showa University, Tokyo, Japan ueshimhi@gmail.com.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Anesthesiology, Showa University, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': 'Anesthesiology, Showa University, Tokyo, Japan.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100091'] 657,32114475,Study protocol of a randomised controlled trial of prostate radiotherapy in high-risk and node-positive disease comparing moderate and extreme hypofractionation (PRIME TRIAL).,"INTRODUCTION There has been an interest in studying the efficacy of extreme hypofractionation in low and intermediate risk prostate cancer utilising the low alpha/beta ratio of prostate. Its role in high-risk and node-positive prostate cancer, however, is unknown. We hypothesise that a five-fraction schedule of extreme hypofractionation will be non-inferior to a moderately hypofractionated regimen over 5 weeks in efficacy and will have acceptable toxicity and quality of life while reducing the cost implications during treatment. METHODS AND ANALYSIS This is an ongoing, non-inferiority, multicentre, randomised trial (NCT03561961) of two schedules for National Cancer Control Network high-risk and/or node-positive non-metastatic carcinoma of the prostate. The standard arm will be a schedule of 68 Gy/25# over 5 weeks while the test arm will be extremely hypofractionated radiotherapy with stereotactic body radiation therapy to 36.25 Gy/5# (7 to 10 days). The block randomisation will be stratified by nodal status (N0/N+), hormonal therapy (luteinizing hormone-releasing hormone therapy/orchiectomy) and centre. All patients will receive daily image-guided radiotherapy.The primary end point is 4-year biochemical failure free survival (BFFS). The power calculations assume 4-year BFFS of 80% in the moderate hypofractionation arm. With a 5% one-sided significance and 80% power, a total of 434 patients will be randomised to both arms equally (217 in each arm). The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure. DISCUSSION The trial aims to establish a therapeutically efficacious and cost-efficient modality for high-risk and node-positive prostate cancer with an acceptable toxicity profile. Presently, this is the only trial evaluating and answering such a question in this cohort. ETHICS AND DISSEMINATION The trial has been approved by IEC-III of Tata Memorial Centre, Mumbai. TRIAL REGISTRATION NUMBER Registered with CTRI/2018/05/014054 (http://ctri.nic.in) on 24 May 2018.",2020,"The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure. ","['434 patients', 'National Cancer Control Network high-risk and/or node-positive non-metastatic carcinoma of the prostate']","['prostate radiotherapy', 'daily image-guided radiotherapy', 'hypofractionated radiotherapy with stereotactic body radiation therapy', 'hormonal therapy (luteinizing hormone-releasing hormone therapy/orchiectomy', 'CTRI/2018/05/014054 (http://ctri.nic.in']","['4-year biochemical failure free survival (BFFS', 'overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1384494', 'cui_str': 'Carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3179062', 'cui_str': 'Image-Guided Radiation Therapy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0029189', 'cui_str': 'Orchidectomy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C3815933', 'cui_str': 'Expenditures, Out-of-Pocket'}]",434.0,0.360152,"The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure. ","[{'ForeName': 'Vedang', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India vmurthy@actrec.gov.in.'}, {'ForeName': 'Indranil', 'Initials': 'I', 'LastName': 'Mallick', 'Affiliation': 'Department of Radiation Oncology, Tata Medical Centre, Kolkata, India.'}, {'ForeName': 'Abhilash', 'Initials': 'A', 'LastName': 'Gavarraju', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Shwetabh', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Krishnatry', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Tejshri', 'Initials': 'T', 'LastName': 'Telkhade', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Arunsingh', 'Initials': 'A', 'LastName': 'Moses', 'Affiliation': 'Department of Radiation Oncology, Tata Medical Centre, Kolkata, India.'}, {'ForeName': 'Sadhna', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Clinical Research Secretariat, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Prakash', 'Affiliation': 'Division of Uro-Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Pal', 'Affiliation': 'Division of Uro-Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Menon', 'Affiliation': 'Department of Pathology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Popat', 'Affiliation': 'Department of Radiology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Rangarajan', 'Affiliation': 'Department of Nuclear Imaging and Bio imaging, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Archi', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Nuclear Imaging and Bio imaging, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Clinical Research Secretariat, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Bakshi', 'Affiliation': 'Division of Uro-Oncology, Tata Memorial Centre, Mumbai, India.'}]",BMJ open,['10.1136/bmjopen-2019-034623'] 658,32114477,"Medroxyprogesterone acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and endometrial carcinoma: trial protocol for a prospective, randomised, open, blinded-endpoint design, dose-response trial (FELICIA trial).","INTRODUCTION Progestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC). However, the results of three meta-analyses revealed a high remission rate, as well as an association with a high rate of relapse. We previously conducted a phase II of medroxyprogesterone acetate (MPA) plus metformin as a fertility-sparing treatment for AEH and EC patients, and reported that metformin inhibited disease relapse after remission. METHODS AND ANALYSIS A randomised, open, blinded-endpoint design phase IIb dose response trial was planned to commence in July 2019. The trial aims to identify the appropriate dose of metformin to be combined with MPA therapy for fertility - sparing treatment of patients with AEH and EC. The primary endpoint of the trial is the 3-year relapse-free survival (RFS) rate. The secondary endpoints are RFS rate, the overall rate of response to MPA therapy, the conception rate after treatment, the outcome of pregnancy, toxicity evaluation and changes in insulin resistance and body mass index. A total of 120 patients will be enrolled from 15 Japanese institutions within a 2.5-year period and followed up for at least 3 years. ETHICS AND DISSEMINATION The protocol was approved by the institutional review board at Chiba University Hospital and boards at 14 other institutions. The trial will be conducted according to the principles of the World Medical Association's Declaration of Helsinki and in accordance with Good Clinical Practice (GCP) standards. The trial findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER Japan Registry of Clinical Trials (jRCT2031190065).",2020,Progestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC).,"['patients with AEH and EC', 'patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC', 'atypical endometrial hyperplasia and endometrial carcinoma', '120 patients will be enrolled from 15 Japanese institutions within a 2.5-year period and followed up for at least 3 years']","['metformin', 'MPA therapy', 'Progestin therapy', 'Medroxyprogesterone acetate plus metformin', 'medroxyprogesterone acetate (MPA) plus metformin']","['3-year relapse-free survival (RFS) rate', 'high remission rate', 'RFS rate, the overall rate of response to MPA therapy, the conception rate after treatment, the outcome of pregnancy, toxicity evaluation and changes in insulin resistance and body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349579', 'cui_str': 'Atypical Endometrial Hyperplasia'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy (procedure)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",120.0,0.180097,Progestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC).,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Mitsuhashi', 'Affiliation': 'Department of Reproductive Medicine, Chiba University Graduate School of Medicine School of Medicine, Chiba, Japan antira@faculty.chiba-u.jp.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hori', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.'}, {'ForeName': 'Tadami', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hanaoka', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.'}, {'ForeName': 'Makio', 'Initials': 'M', 'LastName': 'Shozu', 'Affiliation': 'Department of Reproductive Medicine, Chiba University Graduate School of Medicine School of Medicine, Chiba, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-035416'] 659,32114479,"i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol.","INTRODUCTION There is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue. METHODS AND ANALYSIS Thirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning. ETHICS AND DISSEMINATION This study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients. TRIAL REGISTRATION NUMBER ACTRN12619000952145; Pre-results.",2020,The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined.,"['patients with advanced melanoma receiving', 'Thirty participants will be recruited from a specialist cancer centre between May and September, 2019', 'patients with advanced melanoma receiving immunotherapy', '30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent']","['personalised exercise intervention', 'exercise intervention', 'exercise', 'ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab', 'immunotherapy', 'personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove', 'Immunotherapy', 'iMove, or usual care (an information booklet about exercise']","['safety, adherence to and acceptability', 'Physical assessments measure physical fitness and functioning', ' fatigue, role functioning, symptoms and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0260141', 'cui_str': 'Physiologist (occupation)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",30.0,0.3676,The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined.,"[{'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Hyatt', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Gough', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Murnane', 'Affiliation': 'ONTrac at Peter Mac Victorian Adolescent and Young Adult Cancer Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Au-Yeung', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Dawson', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pearson', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Haryana', 'Initials': 'H', 'LastName': 'Dhillon', 'Affiliation': 'Centre for Medical Psychology and Evidence-based Decision-making, School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Melanoma and Skin Cancer Trials Ltd, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Paton', 'Affiliation': 'Melanoma and Skin Cancer Trials Ltd, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Billett', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Traill', 'Affiliation': 'Occupational Therapy and Physiotherapy Department, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': 'Bristol-Myers Squibb Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Beedle', 'Affiliation': 'Melanoma Patients Australia, Brisbane, Queensland, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Milne', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia donna.milne@petermac.org.'}]",BMJ open,['10.1136/bmjopen-2019-036059'] 660,31449303,Effects of Post-Isometric Relaxation on Ankle Plantarflexion and Timed Flutter Kick in Pediatric Competitive Swimmers.,"Context Ankle plantarflexion is thought to play an important role in swimming performance; thus, coaches and swimmers often seek ways to increase range of motion (ROM) in the ankles. Objective To assess whether osteopathic manipulative treatment (OMT), specifically applying the muscle energy technique (MET) principle of post-isometric relaxation, increases ankle plantarflexion and therefore improves swimming performance. Methods Healthy young male and female competitive swimmers were randomly assigned to either a control, sham, or MET group. At baseline, ankle plantarflexion was measured via goniometer, and a 25-yard flutter kick swim with a kickboard was timed. After receiving the ascribed intervention, the ankle plantarflexion measurements and timed flutter kick were repeated. The initial plantarflexion measurement was retrospectively used to determine the presence of somatic dysfunction, by way of restricted motion, with reference to expected normal ranges based on age and gender. Paired t tests were used to analyze the pre- to postintervention changes in ROM and flutter kick speed within each group. Results Fifty-five swimmers (32 girls and 23 boys; mean age, 12 years) participated in this study. Sixteen participants were in the control group, 17 in the sham group, and 22 in the MET intervention group. Among participants with restricted ROM, those in the MET group showed a statistically significant increase in ankle plantarflexion for the left and right ankles (P=.041 and P=.011, respectively). There was no significant difference in ROM of the control or sham groups. For flutter kick speed, there was no significant pre- to postintervention difference in any group. Conclusion Although a single application of MET, using post-isometric relaxation, on participants with restricted ROM immediately significantly increased swimmers' ROM for bilateral ankle plantarflexion, it did not immediately improve their swimming performance.",2019,"Paired t tests were used to analyze the pre- to postintervention changes in ROM and flutter kick speed within each group. ","['Healthy young male and female competitive swimmers', 'Pediatric Competitive Swimmers', 'Fifty-five swimmers (32 girls and 23 boys; mean age, 12 years) participated in this study', 'Sixteen participants were in the control group, 17 in the sham group, and 22 in the MET intervention group']","['osteopathic manipulative treatment (OMT', 'Post-Isometric Relaxation']","['Ankle Plantarflexion and Timed Flutter Kick', 'ankle plantarflexion for the left and right ankles', 'ankle plantarflexion measurements and timed flutter kick', 'swimming performance', 'ROM and flutter kick speed', 'ROM']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450068', 'cui_str': 'Swimmer (person)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic Manipulative Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0230447', 'cui_str': 'Structure of right ankle'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}]",32.0,0.0280357,"Paired t tests were used to analyze the pre- to postintervention changes in ROM and flutter kick speed within each group. ","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Noto-Bell', 'Affiliation': ''}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Vogel', 'Affiliation': ''}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Senn', 'Affiliation': ''}]",The Journal of the American Osteopathic Association,['10.7556/jaoa.2019.100'] 661,31711065,Repetitive transcranial magnetic stimulation targeting the insular cortex for reduction of heavy drinking in treatment-seeking alcohol-dependent subjects: a randomized controlled trial.,"Insula responses to drug cues are correlated with cravings, and lesions in this area reduce nicotine seeking. Here, we investigated the potential efficacy of repetitive transcranial magnetic stimulation (rTMS) targeting the insula in alcohol addiction. Treatment-seeking alcohol-dependent patients (Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition; N = 56) participated in this double-blind, sham-controlled, randomized trial. Participants received 10 Hz rTMS or sham using an H8 coil, 5 days a week for 3 weeks. Stimulation targeted insular cortex and overlaying regions bilaterally, while excluding anterior prefrontal areas. Craving and self-reported as well as biomarker-based drinking measures were collected at baseline, during treatment, and through 12 weeks. Resting-state magnetic resonance imaging (rsMRI) data were collected before and after treatment. Task-based MRI was used to probe brain correlates of reward processing, affective responses, and alcohol following completion of treatment. A marked overall decrease in craving and drinking measures was observed during treatment, but did not differ between rTMS or sham stimulation. Both groups equally increased their alcohol use following completion of treatment and through the 12-week follow-up. Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function. However, while each task robustly replicated brain responses established in the literature, no effects of rTMS were found. Collectively, this study does not support efficacy of rTMS targeting the insula in alcohol addiction.",2020,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.",['treatment-seeking alcohol-dependent subjects'],"['Repetitive transcranial magnetic stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\u2009Hz rTMS']","['heavy drinking', 'craving and drinking measures']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0893144,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Perini', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden. irene.perini@liu.se.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kämpe', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Arlestig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Löfberg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pietrzak', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0565-7'] 662,32179587,Lifestyle modification in older versus younger patients with coronary artery disease.,"OBJECTIVE To compare the treatment effect on lifestyle-related risk factors (LRFs) in older (≥65 years) versus younger (<65 years) patients with coronary artery disease (CAD) in The Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 (RESPONSE-2) trial. METHODS The RESPONSE-2 trial was a community-based lifestyle intervention trial (n=824) comparing nurse-coordinated referral with a comprehensive set of three lifestyle interventions (physical activity, weight reduction and/or smoking cessation) to usual care. In the current analysis, our primary outcome was the proportion of patients with improvement at 12 months follow-up (n=711) in ≥1 LRF stratified by age. RESULTS At baseline, older patients (n=245, mean age 69.2±3.9 years) had more adverse cardiovascular risk profiles and comorbidities than younger patients (n=579, mean age 53.7±6.6 years). There was no significant variation on the treatment effect according to age (p value treatment by age=0.45, OR 1.67, 95% CI 1.22 to 2.31). However, older patients were more likely to achieve ≥5% weight loss (OR old 5.58, 95% CI 2.77 to 11.26 vs OR young 1.57, 95% CI 0.98 to 2.49, p=0.003) and younger patients were more likely to show non-improved LRFs (OR old 0.38, 95% CI 0.22 to 0.67 vs OR young 0.88, 95% CI 0.61 to 1.26, p=0.01). CONCLUSION Despite more adverse cardiovascular risk profiles and comorbidities among older patients, nurse-coordinated referral to a community-based lifestyle intervention was at least as successful in improving LRFs in older as in younger patients. Higher age alone should not be a reason to withhold lifestyle interventions in patients with CAD.",2020,"There was no significant variation on the treatment effect according to age (p value treatment by age=0.45, OR 1.67, 95% CI 1.22 to 2.31).","['older (≥65 years) versus younger (<65 years) patients with coronary artery disease (CAD) in The Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 (RESPONSE-2) trial', 'patients with CAD', 'older patients (n=245, mean age 69.2±3.9 years) had more adverse cardiovascular risk profiles and comorbidities than younger patients (n=579, mean age 53.7±6.6 years', 'older versus younger patients with coronary artery disease', 'older patients']","['nurse-coordinated referral to a community-based lifestyle intervention', 'nurse-coordinated referral with a comprehensive set of three lifestyle interventions (physical activity, weight reduction and/or smoking cessation) to usual care']","['weight loss', 'LRFs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4277711', 'cui_str': 'Nurse Specialists'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",824.0,0.0563912,"There was no significant variation on the treatment effect according to age (p value treatment by age=0.45, OR 1.67, 95% CI 1.22 to 2.31).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jepma', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands p.jepma@amsterdamumc.nl.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Jorstad', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Snaterse', 'Affiliation': 'Achieve Centre for Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Ter Riet', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kragten', 'Affiliation': 'Cardiology, Zuyderland Medical Centre, Heerlen, The Netherlands.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Lachman', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'Minneboo', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'S Matthijs', 'Initials': 'SM', 'LastName': 'Boekholdt', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ron J', 'Initials': 'RJ', 'LastName': 'Peters', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Scholte Op Reimer', 'Affiliation': 'Achieve Centre for Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-316056'] 663,31745744,Comparison of quantitative flow ratio and fractional flow reserve with myocardial perfusion scintigraphy and cardiovascular magnetic resonance as reference standard. A Dan-NICAD substudy.,"Quantitative flow ratio (QFR) and fractional flow reserve (FFR) have not yet been compared head to head with perfusion imaging as reference for myocardial ischemia. We aimed to compare the diagnostic accuracy of QFR and FFR with myocardial perfusion scintigraphy (MPS) or cardiovascular magnetic resonance (CMR) as reference. This study is a predefined post hoc analysis of the Dan-NICAD study (NCT02264717). Patients with suspected coronary artery disease by coronary computed tomography angiography (CCTA) were randomized 1:1 to MPS or CMR and were referred to invasive coronary angiography with FFR and predefined QFR assessment. Paired data with FFR, QFR and MPS or CMR were available for 232 vessels with stenosis in 176 patients. Perfusion defects were detected in 57 vessel territories (25%). For QFR and FFR the diagnostic accuracy was 61% and 57% (p = 0.18) and area under the receiver operating curve was 0.64 vs. 0.58 (p = 0.22). Stenoses with absolute indication for stenting due to diameter stenosis > 90% by visual estimate were not classified as significant by either QFR or MPS/CMR in 21% (7 of 34) of cases. The diagnostic performance of QFR and FFR was similar but modest with MPS or CMR as reference. Comparable performance levels for QFR and FFR are encouraging for this pressure wire-free diagnostic method.",2020,For QFR and FFR the diagnostic accuracy was 61% and 57% (p = 0.18) and area under the receiver operating curve was 0.64 vs. 0.58 (p = 0.22).,"['Patients with suspected coronary artery disease by coronary computed tomography angiography (CCTA', '232 vessels with stenosis in 176 patients']","['invasive coronary angiography with FFR and predefined QFR assessment', 'FFR, QFR and MPS or CMR', 'myocardial perfusion scintigraphy and cardiovascular magnetic resonance', 'MPS or CMR', 'QFR and FFR with myocardial perfusion scintigraphy (MPS) or cardiovascular magnetic resonance (CMR']","['diagnostic accuracy', 'Perfusion defects', 'diagnostic performance of QFR and FFR', 'Quantitative flow ratio (QFR) and fractional flow reserve (FFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]",232.0,0.0514016,For QFR and FFR the diagnostic accuracy was 61% and 57% (p = 0.18) and area under the receiver operating curve was 0.64 vs. 0.58 (p = 0.22).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sejr-Hansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Århus, Denmark.'}, {'ForeName': 'Jelmer', 'Initials': 'J', 'LastName': 'Westra', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Århus, Denmark. jelmer.westra@clin.au.dk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Winther', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Århus, Denmark.'}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'School of Biochemical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiology, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gormsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Århus, Denmark.'}, {'ForeName': 'Steffen E', 'Initials': 'SE', 'LastName': 'Petersen', 'Affiliation': 'Barts Heart Centre, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ejlersen', 'Affiliation': 'Department of Nuclear Medicine, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Isaksen', 'Affiliation': 'Department of Radiology, Regional Hospital of Silkeborg, Silkeborg, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Århus, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bøttcher', 'Affiliation': 'Department of Cardiology, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Evald H', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Århus, Denmark.'}, {'ForeName': 'Niels Ramsing', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Århus, Denmark.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-019-01737-z'] 664,30307514,Intradialytic kinetics of middle molecules during hemodialysis and hemodiafiltration.,"BACKGROUND The kinetics of β2-microglobulin during hemodialysis and hemodiafiltration is well described by a two-compartment model where clearance by the dialyzer is from a central compartment volume that approximates plasma volume and a total distribution volume that approximates extracellular fluid volume. The kinetics of middle molecules with molecular weights larger than β2-microglobulin have not been extensively studied. METHODS Intradialytic plasma concentrations and overall dialyzer clearances of β2-microglobulin (11.8 kD), myoglobin (16.7 kD) and complement factor D (24.4 kD) were used to estimate three kinetic parameters from a two-compartment model, namely intercompartmental clearance, central compartment volume and total distribution volume, in hemodialysis patients; these data were collected during two clinical trials of medium cut-off dialyzers (with extended middle molecule removal) during hemodialysis and high-flux dialyzers during hemodialysis and hemodiafiltration. In the current exploratory analyses, the kinetic parameters from all dialyzers were combined. Overall dialyzer clearance was evaluated by total mass removed in the dialysate. RESULTS In total, 345 sets of kinetic parameters from 35 patients were determined. Intercompartmental clearance and central compartment volume for myoglobin and complement factor D were smaller (P < 0.001) than those for β2-microglobulin. Independent of middle molecule, intercompartmental clearance and central compartment volume were associated with overall dialyzer clearance (P < 0.001), but total distribution volume was not (P = 0.083). CONCLUSIONS A two-compartment kinetic model can only describe intradialytic kinetics of middle molecules with molecular weights larger than β2-microglobulin if the central compartment is small and dependent on overall dialyzer clearance.",2019,Intercompartmental clearance and central compartment volume for myoglobin and complement factor D were smaller (P < 0.001) than those for β2-microglobulin.,[],"['hemodialysis and hemodiafiltration', 'medium cut-off dialyzers (with extended middle molecule removal) during hemodialysis and high-flux dialyzers during hemodialysis and hemodiafiltration']","['Intradialytic kinetics of middle molecules', 'Intercompartmental clearance and central compartment volume for myoglobin and complement factor D', 'total distribution volume', 'Intradialytic plasma concentrations and overall dialyzer clearances of β2-microglobulin (11.8 kD), myoglobin (16.7 kD) and complement factor D (24.4 kD', 'overall dialyzer clearance', 'Overall dialyzer clearance']",[],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0033457', 'cui_str': 'Properdin Factor D'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}]",35.0,0.0178721,Intercompartmental clearance and central compartment volume for myoglobin and complement factor D were smaller (P < 0.001) than those for β2-microglobulin.,"[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Leypoldt', 'Affiliation': 'Baxter Healthcare Corporation, Deerfield, IL, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Storr', 'Affiliation': 'Gambro Dialysatoren, Hechingen, Germany.'}, {'ForeName': 'Baris U', 'Initials': 'BU', 'LastName': 'Agar', 'Affiliation': 'Baxter Healthcare Corporation, Deerfield, IL, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Boschetti-de-Fierro', 'Affiliation': 'Gambro Dialysatoren, Hechingen, Germany.'}, {'ForeName': 'Angelito A', 'Initials': 'AA', 'LastName': 'Bernardo', 'Affiliation': 'Baxter Healthcare Corporation, Deerfield, IL, USA.'}, {'ForeName': 'Alexander H', 'Initials': 'AH', 'LastName': 'Kirsch', 'Affiliation': 'Clinical Division of Nephrology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Rosenkranz', 'Affiliation': 'Clinical Division of Nephrology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Detlef H', 'Initials': 'DH', 'LastName': 'Krieter', 'Affiliation': 'University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Krause', 'Affiliation': 'Gambro Dialysatoren, Hechingen, Germany.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfy304'] 665,31530612,Ambulatory cancer care electronic symptom self-reporting (ACCESS) for surgical patients: a randomised controlled trial protocol.,"INTRODUCTION An increasing proportion of cancer surgeries are ambulatory procedures requiring a stay of 1 day or less in the hospital. Providing patients and their caregivers with ongoing, real-time support after discharge aids delivery of high-quality postoperative care in this new healthcare environment. Despite abundant evidence that patient self-reporting of symptoms improves quality of care, the most effective way to monitor and manage this self-reported information is not known. METHODS AND ANALYSIS This is a two-armed randomised, controlled trial evaluating two approaches to the management of patient-reported data: (1) team monitoring, symptom monitoring by the clinical team, with nursing outreach if symptoms exceed normal limits, and (2) enhanced feedback, real-time feedback to patients about expected symptom severity, with patient-activated care as needed.Patients with breast, gynaecologic, urologic, and head and neck cancer undergoing ambulatory cancer surgery (n=2750) complete an electronic survey for up to 30 days after surgery that includes items from a validated instrument developed by the National Cancer Institute, the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Information provided to patients in the Enhanced Feedback group is procedure-specific and based on updated PRO-CTCAE data from previous patients. Qualitative interviews are also performed. The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden). ETHICS AND DISSEMINATION This study is approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center. The relationships between the study team and stakeholders will be leveraged to disseminate study findings. Findings will be relevant in designing future coordinated care models targeting improved healthcare quality and patient experience. TRIAL REGISTRATION NUMBER NCT03178045.",2019,"The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden). ","['Patients with breast, gynaecologic, urologic, and head and neck cancer undergoing ambulatory cancer surgery (n=2750', 'surgical patients']",['Ambulatory cancer care electronic symptom self-reporting (ACCESS'],"['unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0920424'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.14972,"The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden). ","[{'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Stabile', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Larissa K', 'Initials': 'LK', 'LastName': 'Temple', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Ancker', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medical College, New York City, New York, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Department of Health Policy and Management, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Magen', 'Initials': 'M', 'LastName': 'Miranda', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medical College, New York City, New York, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Stetson', 'Affiliation': 'Division of Health Informatics, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vickers', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA simonb1@mskcc.org.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Pusic', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, Manhattan, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-030863'] 666,32173165,The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey.,"PURPOSE The study was conducted to determine the effect of the cartoon-assisted preparation package, developed for children undergoing an endoscopy procedure, on children's fear and anxiety levels and parental satisfaction. DESIGN AND METHODS The study was conducted in a randomized controlled experimental design between April 2018-July 2019. The study sample consisted of a total of 65 children and their parents (33 in the intervention group and 32 in the control group) who met the research inclusion criteria in this study population. The intervention group was prepared for an endoscopy procedure with the cartoon-assisted preparation package for endoscopy. RESULTS The mean fear scores of the children in the intervention group were 3.39 ± 0.56 before endoscopy, 1.67 ± 0.54 during endoscopy, and 0.52 ± 0.67 after endoscopy, with statistically significant difference between the mean fear scores. The mean fear scores in the control group were 3.00 ± 0.80 before endoscopy, 3.13 ± 0.79 during endoscopy, and 2.25 ± 1.16 after endoscopy, with statistically significant difference between the mean fear scores. The anxiety scores of the children were 33.79 ± 4.00 in the intervention group and 36.56 ± 3.52 in the control group before endoscopy, and the difference between anxiety scores was statistically significant (p < 0.05). The mean satisfaction scores of the parents in the experimental group after endoscopy (78.44 ± 10.01) was higher than that of the control group (73.52 ± 12.92), but the difference between the groups was not statistically significant (p > 0.05). CONCLUSION The cartoon-assisted preparation package for endoscopy was found to be effective in reducing fear and anxiety that may occur in children undergoing endoscopy, in the 7-12 age group.",2020,"The cartoon-assisted preparation package for endoscopy was found to be effective in reducing fear and anxiety that may occur in children undergoing endoscopy, in the 7-12 age group.","[""children's fear and anxiety levels and parental satisfaction in Turkey"", ""children undergoing an endoscopy procedure, on children's fear and anxiety levels and parental satisfaction"", 'children undergoing endoscopy, in the 7-12 age group', '65 children and their parents (33 in the intervention group and 32 in the control group) who met the research inclusion criteria in this study population', 'April 2018-July 2019']","['cartoon-assisted preparation package', 'cartoon assisted endoscopy preparation package', 'endoscopy procedure with the cartoon-assisted preparation package for endoscopy']","['mean fear scores', 'anxiety scores', 'mean satisfaction scores', 'fear and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",65.0,0.0330311,"The cartoon-assisted preparation package for endoscopy was found to be effective in reducing fear and anxiety that may occur in children undergoing endoscopy, in the 7-12 age group.","[{'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Köse', 'Affiliation': 'Department of Child Health and Diseases Nursing, Faculty of Nursing, Necmettin Erbakan University, Konya, Turkey. Electronic address: semraak_88@hotmail.com.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Arıkan', 'Affiliation': 'Department of Child Health and Diseases Nursing, Faculty of Nursing, Ataturk University, Erzurum, Turkey.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.02.010'] 667,31425752,The Dry Eye Assessment and Management (DREAM) extension study - A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease.,"PURPOSE To determine effects of continued or discontinued use of omega-3 (ω3) fatty acid supplements through a randomized withdrawal trial among patients assigned to ω3 supplements in the first year of the DREAM study. METHODS Patients who were initially assigned to ω3 (3000 mg) for 12 months in the primary trial were randomized 1:1 to ω3 active supplements or placebos (refined olive oil) for 12 more months. The primary outcome was change in the Ocular Surface Disease Index (OSDI) score. Secondary outcomes included change in conjunctival staining, corneal staining, tear break-up time, Schirmer test, and adverse events. RESULTS Among 22 patients assigned to ω3 and 21 to placebo supplements, the mean change in OSDI score between month 12 and 24 was similar between treatment groups (mean difference in change -0.6 points, 95% confidence interval [CI], (-10.7, 9.5), p = 0.91). There were no significant differences between groups in mean change in conjunctival staining (difference in mean change -0.5 points; 95% CI (-1.2, 0.3)), corneal staining (-0.3 points; 95% CI (-1.2, 0.3)), tear break-up time (-0.8 s; 95% CI (-2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI (-2.0, 3.2)). Rates of adverse events were similar in both groups. CONCLUSION Among patients who received ω3 supplements for 12 months in the primary trial, those discontinuing use of ω3 for an additional 12 months did not have significantly worse outcomes compared to those who continued use of ω3. ClinicalTrials.gov number NCT02128763.",2020,"There were no significant differences between groups in mean change in conjunctival staining (difference in mean change -0.5 points; 95% CI (-1.2, 0.3)), corneal staining (-0.3 points; 95% CI (-1.2, 0.3)), tear break-up time (-0.8 s; 95% CI (-2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI (-2.0, 3.2)).","['Patients who were initially assigned to ω3 (3000\u202fmg) for 12 months in the primary trial', '22 patients assigned to ω3 and 21 to', 'patients assigned to ω3 supplements in the first year of the DREAM study', 'patients with dry eye disease']","['omega-3 fatty acid', 'ω3 active supplements or placebos (refined olive oil', 'placebo', 'omega-3 (ω3) fatty acid supplements']","['Rates of adverse events', 'corneal staining', 'tear break-up time', 'mean change in conjunctival staining', 'mean change in OSDI score', 'change in conjunctival staining, corneal staining, tear break-up time, Schirmer test, and adverse events', 'Ocular Surface Disease Index (OSDI) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.374989,"There were no significant differences between groups in mean change in conjunctival staining (difference in mean change -0.5 points; 95% CI (-1.2, 0.3)), corneal staining (-0.3 points; 95% CI (-1.2, 0.3)), tear break-up time (-0.8 s; 95% CI (-2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI (-2.0, 3.2)).","[{'ForeName': 'Munira', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Roni M', 'Initials': 'RM', 'LastName': 'Shtein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Pistilli', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: maguirem@pennmedicine.upenn.edu.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Oydanich', 'Affiliation': 'Rutgers-New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Asbell', 'Affiliation': 'Department of Ophthalmology, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The ocular surface,['10.1016/j.jtos.2019.08.002'] 668,32173478,"Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial.","BACKGROUND & AIMS There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blind, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. METHODS Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. RESULTS Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). CONCLUSIONS In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference. Clinicaltrials.gov ID NCT01936948.",2020,There were no significant differences between groups in proportions of polyps that were completely removed (96% in the in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%).,"['multiple centers, from April 2013 through October 2017', 'Patients were evaluated 30 days after the procedure (n=919), and 675 patients underwent a', 'Patients undergoing endoscopic mucosal resection of non-pedunculated colorectal polyps 20 mm or larger (n=928']","['clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation; Erbe Inc.) (secondary intervention', 'electrosurgical setting', 'Blended (Yellow) vs Forced Coagulation (Blue) Currents', 'surveillance colonoscopy']","['adverse events', 'Adverse Events, Complete Resection, or Polyp Recurrence', 'immediate bleeding', 'proportions of polyps', 'risk of serious adverse events, complete resection rate, or polyp recurrence', 'severe adverse event', 'occurrence of types of events', 'complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis']","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1700928', 'cui_str': 'Endoscopic Mucous Membrane Resection'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.159884,There were no significant differences between groups in proportions of polyps that were completely removed (96% in the in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%).,"[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Pohl', 'Affiliation': 'Dartmouth Geisel School of Medicine, Hanover, New Hampshire; Section of Gastroenterology and Hepatology, Veterans Affairs White River Junction, Vermont. Electronic address: Heiko.pohl@dartmouth.edu.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Grimm', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Moyer', 'Affiliation': 'Matthew T. Moyer, Division of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Muhammad K', 'Initials': 'MK', 'LastName': 'Hasan', 'Affiliation': 'Muhammad K. Hasan, Center for Interventional Endoscopy, Florida Hospital, Orlando, Florida.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Pleskow', 'Affiliation': 'Douglas Pleskow, Division of Gastroenterology Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Mouen A', 'Initials': 'MA', 'LastName': 'Khashab', 'Affiliation': 'Mouen A. Khashab, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sanaei', 'Affiliation': 'Mouen A. Khashab, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Firas H', 'Initials': 'FH', 'LastName': 'Al-Kawas', 'Affiliation': 'Mouen A. Khashab, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland; Sibley Memorial Hospital, Washington, DC.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Gordon', 'Affiliation': 'Dartmouth Geisel School of Medicine, Hanover, New Hampshire; Department of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Mathew', 'Affiliation': 'Matthew T. Moyer, Division of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Levenick', 'Affiliation': 'Matthew T. Moyer, Division of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Aslanian', 'Affiliation': 'Section of Digestive Diseases, Yale-New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Antaki', 'Affiliation': 'Division of Gastroenterology, John D. Dingell Veterans Affairs Medical Center and Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'von Renteln', 'Affiliation': 'Division of Gastroenterology, University of Montreal Medical Center and Research Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Crockett', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Gastroenterology, Hepatology and Motility, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Gill', 'Affiliation': 'Division of Gastroenterology James A. Haley Veterans Affairs, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Law', 'Affiliation': 'Division of Gastroenterology and Hepatology University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Pooja A', 'Initials': 'PA', 'LastName': 'Elias', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pellise', 'Affiliation': 'Gastroenterology Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Mackenzie', 'Affiliation': 'The Dartmouth Institute, Department for Biomedical Data Science, Lebanon, New Hampshire.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Rex', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}]",Gastroenterology,['10.1053/j.gastro.2020.03.014'] 669,32173113,Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial.,"PURPOSE Injection of pharmacotherapy into the suprachoroidal space, between the sclera and choroid, is an alternative delivery technique developed with the rationale of providing higher drug concentrations to posterior ocular structures compared with other intraocular and periocular injection procedures. This study was conducted to evaluate the safety and efficacy of suprachoroidally injected triamcinolone acetonide formulation (CLS-TA), a suspension of triamcinolone acetonide, in improving vision among patients with noninfectious uveitis complicated by macular edema (ME). DESIGN Phase 3 masked, randomized trial. PARTICIPANTS One hundred sixty patients with ME secondary to noninfectious uveitis. Patients were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40) in the study eye. METHODS Patients were randomized 3:2 to suprachoroidally injected CLS-TA or sham treatment, with administrations at day 0 and week 12. MAIN OUTCOME MEASURES The primary end point was improvement from baseline of 15 or more ETDRS letters in BCVA at week 24. The secondary end point was reduction from baseline in central subfield thickness (CST) at week 24. RESULTS In the CLS-TA arm, 47% of patients gained 15 or more ETDRS letters in BCVA versus 16% in the control arm (P < 0.001), meeting the primary end point. Mean reductions in CST from baseline were 153 μm versus 18 μm (P < 0.001). No serious adverse events (AEs) related to treatment were reported. Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively. Cataract AE rates were comparable (7.3% and 6.3%, respectively). CONCLUSIONS Patients in the CLS-TA study arm experienced clinically significant improvement in vision relative to the sham procedure, demonstrating the efficacy of suprachoroidal injection of CLS-TA for the treatment of ME in a vision-threatening disorder.",2020,"Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively.","['Macular Edema Secondary to Noninfectious Uveitis', 'Patients were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40) in the study eye', 'One hundred sixty patients with ME secondary to noninfectious uveitis', 'Patients', 'patients with noninfectious uveitis complicated by macular edema (ME']","['Suprachoroidal CLS-TA', 'triamcinolone acetonide formulation (CLS-TA', 'triamcinolone acetonide', 'CLS-TA']","['Mean reductions in CST', 'vision relative', 'baseline of 15 or more ETDRS letters in BCVA', 'elevated intraocular pressure', 'Cataract AE rates', 'safety and efficacy', 'central subfield thickness (CST']","[{'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",160.0,0.133388,"Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Yeh', 'Affiliation': 'Emory Eye Center, Emory University School of Medicine, Atlanta, Georgia; Emory Global Health Institute, Emory University, Atlanta, Georgia. Electronic address: syeh3@emory.edu.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Henry', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Wang', 'Affiliation': 'Texas Retina Associates, Dallas, Texas.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Kissner', 'Affiliation': 'Clearside Biomedical, Inc., Alpharetta, Georgia.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Ciulla', 'Affiliation': 'Clearside Biomedical, Inc., Alpharetta, Georgia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Noronha', 'Affiliation': 'Clearside Biomedical, Inc., Alpharetta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.01.006'] 670,32167226,Custom and prefabricated PolyEtherKetoneKetone (PEKK) post-core systems bond strength: Scanning electron microscopy evaluation.,"The present study evaluated the bond strengths of prefabricated PolyEtherKetoneKetone (PEKK) posts, PEKK posts custom-configured according to root-canal size, and conventional fiber posts. A total of 30 maxillary incisors were randomly divided into three groups, as follows: Group 1: fiber posts; Group 2: prefabricated PEKK posts; Group 3; custom-made PEKK posts. Following endodontic treatment, post spaces were prepared, and posts were cemented with resin cement. Push-out bond strength testing was performed using a universal testing machine, and fractures modes were examined under a scanning electron microscope. Data were analyzed using One-way ANOVA and Tukey's HSD tests, with the level of significance set at .05. The highest bond-strength values in the cervical section were observed with the custom-made PEKK post (17.3470 MPa), whereas the highest bond-strength values in the middle and apical sections were observed with the conventional fiber posts (11.5375 MPa and 6.8625 MPa, respectively). Bond-strength values for all posts systems decreased in a cervical to apical direction. PEKK posts are a suitable alternative to fiber posts. Although custom-made PEKK posts demonstrated better bond strength than prefabricated PEKK posts, further studies are needed to evaluate their clinical performance.",2020,"Although custom-made PEKK posts demonstrated better bond strength than prefabricated PEKK posts, further studies are needed to evaluate their clinical performance.",['A total of 30 maxillary incisors'],['fiber posts; Group 2: prefabricated PEKK posts; Group 3; custom-made PEKK posts'],"['highest bond-strength values', 'bond strength']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0162343', 'cui_str': 'Customs'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0131857,"Although custom-made PEKK posts demonstrated better bond strength than prefabricated PEKK posts, further studies are needed to evaluate their clinical performance.","[{'ForeName': 'Melahat Çelik', 'Initials': 'MÇ', 'LastName': 'Güven', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Istanbul Yeni Yüzyıl University, Istanbul, Turkey.'}, {'ForeName': 'Süleyman Çağatay', 'Initials': 'SÇ', 'LastName': 'Dayan', 'Affiliation': 'Program of Dental Technicians, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Gülhan', 'Initials': 'G', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Istanbul Yeni Yüzyıl University, Istanbul, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Mumcu', 'Affiliation': 'Department of Prosthodontics. Faculty of Dentistry, Eskisehir Osmangazi University, Odunpazarı, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23471'] 671,32180066,Phase 2 Trial of Adjuvant Chemotherapy With S - 1 for Node-Positive Biliary Tract Cancer (N-SOG 09).,"BACKGROUND Nodal metastasis is a leading attributable factor of poor survival in biliary tract cancer (BTC), and adjuvant chemotherapy targeting this high-risk feature has not been attempted to date. This study aimed to test the efficacy of adjuvant S - 1 for patients with node-positive BTC. METHODS This single-arm multicenter phase 2 trial enrolled patients who underwent resection for histologically proven node-positive BTC. In this trial, S - 1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 6 months. The primary end point of the trial was 3-year overall survival (OS), in which the result would be promising if the 90% confidence interval (CI) surpassed a threshold of 30% (alpha error, 0.1; beta error, 0.2). The secondary end points were relapse-free survival (RFS), feasibility, and toxicity. RESULTS The trial included 50 patients with perihilar (n = 23) or distal (n = 20) cholangiocarcinoma, or gallbladder cancer (n = 7). The median numbers of positive lymph nodes and examined lymph nodes were respectively 2 and 15. The 3-year OS and RFS were respectively 50% (90% CI, 40.9-59.1%) and 32.0% (95% CI, 19.1-44.9%), with median survival times of 34.6 months (95% CI, 19.3-49.8 months) and 18.4 months (95% CI, 11.9-24.9 months). Although hematologic toxicity often occurred, grades 3 and 4 toxicity were rare. The completion rate of the test therapy was 64%, and the median relative dose intensity was 87.5% (interquartile range, 50-100%). CONCLUSION Adjuvant chemotherapy with S - 1 may be promising for patients with node-positive BTC.",2020,"The 3-year OS and RFS were respectively 50% (90% CI, 40.9-59.1%) and 32.0% (95% CI, 19.1-44.9%), with median survival times of 34.6 months (95% CI, 19.3-49.8 months) and 18.4 months (95% CI, 11.9-24.9 months).","['Node-Positive Biliary Tract Cancer', 'enrolled patients who underwent resection for histologically proven node-positive BTC', 'patients with node-positive BTC', '50 patients with perihilar (n\u2009=\u200923) or distal (n\u2009=\u200920) cholangiocarcinoma, or gallbladder cancer (n\u2009=\u20097']","['Adjuvant Chemotherapy', 'Adjuvant chemotherapy', 'adjuvant S\u2009-\u20091']","['median relative dose intensity', 'median numbers of positive lymph nodes and examined lymph nodes', 'hematologic toxicity', 'median survival times', '3-year overall survival (OS', 'relapse-free survival (RFS), feasibility, and toxicity', '3-year OS and RFS', 'completion rate of the test therapy']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocellular Carcinoma'}, {'cui': 'C0153452', 'cui_str': 'Cancer of Gallbladder'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",50.0,0.626957,"The 3-year OS and RFS were respectively 50% (90% CI, 40.9-59.1%) and 32.0% (95% CI, 19.1-44.9%), with median survival times of 34.6 months (95% CI, 19.3-49.8 months) and 18.4 months (95% CI, 11.9-24.9 months).","[{'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Seita', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ebata', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. tomoki@med.nagoya-u.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Surgery, Kasugai Municipal Hospital, Kasugai, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kurumiya', 'Affiliation': 'Department of Surgery, Toyota Kosei Hospital, Toyota, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Surgery, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Surgery, Toyohashi Municipal Hospital, Toyohashi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nagino', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Annals of surgical oncology,['10.1245/s10434-020-08355-3'] 672,32167975,ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery.,"BACKGROUND Recent limited evidence suggests that the use of a processed electroencephalographic (EEG) monitor to guide anesthetic management may influence postoperative cognitive outcomes; however, the mechanism is unclear. METHODS This exploratory, single-center, randomized clinical trial included patients who were ≥65 years of age undergoing elective noncardiac surgery. The study aimed to determine whether monitoring the brain using a processed EEG monitor reduced EEG suppression and subsequent postoperative delirium. The interventional group received processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA), while the standard care group was also monitored, but the EEG data were blinded from the clinicians. The primary outcome was intraoperative EEG suppression. A secondary outcome was incident postoperative delirium during the first 3 days after surgery. RESULTS All outcomes were analyzed using the intention-to-treat paradigm. Two hundred and four patients with a mean age of 72 ± 5 years were studied. Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]). The effect of the intervention on EEG suppression differed for those with and without preoperative cognitive impairment (interaction P = .01), with the estimated incidence rate ratio (95% CI) of 0.39 (0.33-0.44) for those with preoperative cognitive impairment and 0.48 (0.44-0.51) for those without preoperative cognitive impairment. The incidence of delirium was not found to be different between the interventional (17%) and the standard care groups (20%), risk ratio = 0.85 (95% CI, 0.47-1.5). CONCLUSIONS The use of processed EEG to maintain the PSI >35 was associated with less time spent in intraoperative EEG suppression. Preoperative cognitive impairment was associated with a greater percent of surgical time spent in EEG suppression. A larger prospective cohort study to include more cognitively vulnerable patients is necessary to show whether an intervention to reduce EEG suppression is efficacious in reducing postoperative delirium.",2020,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","['patients who were ≥65 years of age undergoing elective noncardiac surgery', 'cognitively vulnerable patients', 'Two hundred and four patients with a mean age of 72 ± 5 years were studied', 'Older Surgical Patients Undergoing Major Noncardiac Surgery']","['Intraoperative EEG Suppression', 'processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA', 'ADAPT-2']","['EEG suppression', 'incidence rate ratio', 'EEG suppression and subsequent postoperative delirium', 'incident postoperative delirium', 'intraoperative EEG suppression', 'Minutes of EEG suppression adjusted by the length of surgery', 'incidence of delirium', 'Preoperative cognitive impairment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0430854', 'cui_str': 'Electroencephalogram for monitoring at surgery (regime/therapy)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0430854', 'cui_str': 'Electroencephalogram for monitoring at surgery (regime/therapy)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",204.0,0.158331,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Tang', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Zhongnan', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Sands', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Pleasants', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Tabatabai', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Leung', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004713'] 673,32174079,[Effect of three-dimensional printing guide plate on improving femoral rotational alignment and patellar tracking in total knee arthroplasty].,"Objective To investigate the effect of three-dimensional (3D) printing guide plate on improving femoral rotational alignment and patellar tracking in total knee arthroplasty (TKA). Methods Between January 2018 and October 2018, 60 patients (60 knees) with advanced knee osteoarthritis who received TKA and met the selection criteria were selected as the study subjects. Patients were randomly divided into two groups according to the random number table method, with 30 patients in each group. The TKA was done with the help of 3D printing guide plate in the guide group and following traditional procedure in the control group. There was no significant difference in gender, age, disease duration, side, and preoperative hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA), Hospital for Special Surgery (HSS) score, and American Knee Society (AKS) score ( P >0.05). Results All incisions healed by first intention and no complications related to the operation occurred. All patients were followed up 10-12 months, with an average of 11 months. HSS score and AKS score of the two groups at 6 months after operation were significantly higher than those before operation ( P <0.05), but there was no significant difference between the two groups ( P >0.05). Postoperative X-ray films showed that the prosthesis was in good position, and no prosthesis loosening or sinking occurred during follow-up. HKA, PCA, and PFA significantly improved in the two groups at 10 months after operation compared with those before operation ( P <0.05). There was no significant difference in HKA at 10 months between the two groups ( t =1.031, P =0.307). PCA and PFA in the guide group were smaller than those in the control group ( P <0.05). Conclusion Application of 3D printing guide plate in TKA can not only correct the deformity of the knee joint and alleviate the pain symptoms, but also achieve the goal of the accurate femoral rotation alignment and good patellar tracking.",2020,"PCA and PFA in the guide group were smaller than those in the control group ( P <0.05). ","['Methods\n\n\nBetween January 2018 and October 2018, 60 patients (60 knees) with advanced knee osteoarthritis who received TKA and met the selection criteria were selected as the study subjects', 'total knee arthroplasty (TKA', 'total knee arthroplasty']","['three-dimensional (3D) printing guide plate', 'TKA', 'three-dimensional printing guide plate']","['HKA, PCA, and PFA', 'HSS score and AKS score', 'PCA and PFA', 'femoral rotational alignment and patellar tracking', 'HKA', 'gender, age, disease duration, side, and preoperative hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA), Hospital for Special Surgery (HSS) score, and American Knee Society (AKS) score', 'prosthesis loosening or sinking']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C3849992', 'cui_str': '3-Dimensional Printing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0033587', 'cui_str': 'Prosthesis Loosening'}]",,0.0131973,"PCA and PFA in the guide group were smaller than those in the control group ( P <0.05). ","[{'ForeName': 'Maolin', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Center for Joint Surgery, the First Affiliated Hospital, Army Medical University, Chongqing, 400038, P.R.China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Center for Joint Surgery, the First Affiliated Hospital, Army Medical University, Chongqing, 400038, P.R.China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Center for Joint Surgery, the First Affiliated Hospital, Army Medical University, Chongqing, 400038, P.R.China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Hao', 'Affiliation': 'Center for Joint Surgery, the First Affiliated Hospital, Army Medical University, Chongqing, 400038, P.R.China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Center for Joint Surgery, the First Affiliated Hospital, Army Medical University, Chongqing, 400038, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201907045'] 674,31622033,"Effectiveness of a Social Media-Based, Health Literacy-Sensitive Diabetes Self-Management Intervention: A Randomized Controlled Trial.","AIMS The purpose of the study was to evaluate the effects of a social media-based, health literacy-sensitive diabetes management intervention on patient activation, self-care behaviors, and glucose control compared to telephone-based, health literacy-sensitive diabetes management intervention and usual care. Additionally, this study aimed to identify how patient health literacy influenced the effectiveness of health literacy-sensitive diabetes management interventions. DESIGN 3 (treatment condition) × 2 (health literacy level) randomized factorial trial. METHODS In total, 151 patients diagnosed with type 2 diabetes were randomly assigned to the social media-based or telephone-based, health literacy-sensitive diabetes management interventions or the usual care control. The health literacy-sensitive diabetes management intervention consisted of an initial face-to-face diabetes nurse education using easy-to-read educational materials, the teach-back method, and eight weekly action-planning sessions guided with the use of social media or phone calls for each group. FINDINGS Patients with high health literacy at the 9-week follow-up showed higher levels of patient activation than those with low health literacy in the control group, but the effect of health literacy was no longer significant when patients were provided with social media-based or telephone-based interventions. Patients who received the telephone-based, health literacy-sensitive diabetes management intervention had a significantly higher score for self-care behaviors than the usual care control group at 9 weeks' follow-up. No other effects for self-care behaviors or glycated hemoglobin were significant at follow-up. CONCLUSIONS The social media-based, health literacy-sensitive diabetes management intervention was effective at mitigating the disadvantages faced by people with low health literacy when attempting to improve self-care activation. CLINICAL RELEVANCE Social media-based self-management interventions accommodating low health literacy have the potential to help people overcome their disadvantages associated with low health literacy.",2019,", health literacy-sensitive diabetes management intervention was effective at mitigating the disadvantages faced by people with low health literacy when attempting to improve self-care activation. ","['3 (treatment condition', 'Patients with high health literacy', '151 patients diagnosed with type 2 diabetes']","['social media-based, health literacy-sensitive diabetes management intervention', 'social media-based or telephone-based, health literacy-sensitive diabetes management interventions or the usual care control', 'Social Media-Based, Health Literacy-Sensitive Diabetes Self-Management Intervention', 'telephone-based, health literacy-sensitive diabetes management intervention', 'health literacy-sensitive diabetes management intervention consisted of an initial face-to-face diabetes nurse education using easy-to-read educational materials, the teach-back method, and eight weekly action-planning sessions guided with the use of social media or phone calls for each group', 'telephone-based, health literacy-sensitive diabetes management intervention and usual care']","['health literacy', 'levels of patient activation', 'score for self-care behaviors', 'patient activation, self-care behaviors, and glucose control', 'self-care behaviors or glycated hemoglobin']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}]",151.0,0.0133422,", health literacy-sensitive diabetes management intervention was effective at mitigating the disadvantages faced by people with low health literacy when attempting to improve self-care activation. ","[{'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Research Institute of Nursing Science, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Utz', 'Affiliation': 'Social Media Leibniz-Institut für Wissensmedien, University of Tübingen, Tübingen, Germany.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12521'] 675,32168090,Mindfulness Meditation and Anxiety in Nursing Students.,"This quasi-experimental study used a convenience sample of nursing students (n = 49) to evaluate the effectiveness of mindfulness meditation on anxiety. Students participated in mindfulness meditation sessions and completed the State-Trait Anxiety Inventory. A statistically significant reduction in trait anxiety was found in the intervention group (p = .000); state anxiety decreased but not significantly. In contrast, anxiety increased significantly in the comparison group, but progression was not significantly different between groups. Trait anxiety may decrease with mindfulness meditation.",2020,A statistically significant reduction in trait anxiety was found in the intervention group (p = .000); state anxiety decreased but not significantly.,"['convenience sample of nursing students (n = 49', 'Nursing Students']","['mindfulness meditation', 'mindfulness meditation sessions']","['state anxiety', 'anxiety', 'Mindfulness Meditation and Anxiety', 'Trait anxiety', 'trait anxiety']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]",,0.0156542,A statistically significant reduction in trait anxiety was found in the intervention group (p = .000); state anxiety decreased but not significantly.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Stinson', 'Affiliation': 'About the Authors Cynthia Stinson PhD, APRN, CNS, RN-BC, is chair and associate professor; Eileen Curl, PhD, RN, ANEF, is professor and director of research; Gina Hale, PhD, RN, CNE, is assistant professor; Stacey Knight, DNP, RN, CNE, is assistant professor; Cynthia Pipkins, PhD, RN, HNB-BC, is assistant professor; Iva Hall, PhD, RN, is associate professor; Kelli White, MSN, RN, is an instructor, JoAnne Gay Dishman School of Nursing, Lamar University, Beaumont, Texas. Nancy Thompson, LCSW, RN, is a licensed clinical social worker and nurse, Beaumont, Texas. Christy Wright, MSN, RN, former graduate assistant at Dishman School of Nursing, is a staff nurse, CHRISTUS Southeast Texas St. Elizabeth, Beaumont, Texas.'}, {'ForeName': 'Eileen Deges', 'Initials': 'ED', 'LastName': 'Curl', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Hale', 'Affiliation': ''}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Knight', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pipkins', 'Affiliation': ''}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': ''}]",Nursing education perspectives,['10.1097/01.NEP.0000000000000635'] 676,32171731,Methods for Dissecting Intersegmental Planes in Segmentectomy: A Randomized Controlled Trial.,"BACKGROUND The perioperative outcomes of the use of stapling devices versus electrocautery to dissect intersegmental planes in patients undergoing segmentectomy for small pulmonary lesions is still unclear. The aim of this randomized controlled trial was to compare the perioperative outcomes of these two methods. METHODS A single-center, prospective, participant-blinded, randomized controlled trial (NCT03192904) was conducted with a preplanned sample size of 136. The primary outcome was the incidence of postoperative complications. Secondary outcomes included duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function, and medical costs. RESULTS The trial was stopped early as a result of a marked difference in the primary outcome between groups at a scheduled interim check of the data after recruiting 70 patients. The incidence of postoperative complications (eg, air leakage) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs 2/33, 6.1%, P = .004). There were no differences in duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials was higher in the stapler device group (US$4214.6 ± 1185.4 vs $3260.1 ± 852.6, P < .001). CONCLUSIONS Among patients undergoing segmentectomy, the use of stapler devices to divide intersegmental planes decreased postoperative complications without further compromising lung function or increasing economic burden.",2020,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","['Segmentectomy', 'patients undergoing segmentectomy', 'patients undergoing segmentectomy for small pulmonary lesions']",['stapling devices versus electrocautery'],"['postoperative complications', 'surgery duration, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials', 'incidence of postoperative complications', 'duration of surgery, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function and medical costs', 'incidence of postoperative complications (e.g., air leakage etc']","[{'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333257', 'cui_str': 'Air leakage (morphologic abnormality)'}]",70.0,0.196245,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","[{'ForeName': 'Xingshi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Dingpei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Chengqiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Hailei', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Junbiao', 'Initials': 'J', 'LastName': 'Hang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Alan D L', 'Initials': 'ADL', 'LastName': 'Sihoe', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Hong Kong; The University of Hong Kong Shenzhen Hospital, Shenzhen; Department of Thoracic Surgery, Tongji University, Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Hecheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai. Electronic address: lihecheng2000@hotmail.com.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.02.013'] 677,32171765,The Prognostic Value of Persistent Culture Positivity in Fungal Keratitis in the Mycotic Antimicrobial Localized Injection Trial.,"PURPOSE To evaluate the utility of repeat cultures at days 3 and 7 after starting antifungal medications for predicting outcomes in fungal keratitis. DESIGN Prespecified secondary analysis of the randomized clinical Mycotic Antimicrobial Localized Injection trial. METHODS Patients presenting to Aravind Eye Hospital, Pondicherry, India, with fungal keratitis and visual acuity worse than 20/70 received topical natamycin and were randomized to either receive intrastromal injection of voriconazole or topical therapy alone. All subjects received corneal cultures at date of presentation, day 3, and day 7. Outcome measures included 3-week and 3-month visual acuity and scar size, corneal perforation, and/or the need for therapeutic penetrating keratoplasty (TPK). Visual acuity and scar size were analyzed with multiple linear regression controlling for baseline measures. Survival analysis was used to analyze the risk of corneal perforation and/or need for TPK. RESULTS Of the 70 study subjects with fungal keratitis, 25 of 69 (36%) remained culture positive at day 3, and 20 of 62 (32%) were culture positive at day 7. Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (P = .03) but was not a statistically significant predictor of perforation, scar size, or final visual acuity. Culture positivity at day 7 had a hazard ratio of 3.5 for requiring TPK (P = .003). Those with positive cultures at day 7 had on average 3 logMAR lines worse visual acuity at 3 months (95% confidence interval 0.9 to 5.2 logMAR lines, P = .006) and 1.1 mm larger scar size at 3 months after controlling for baseline measures (95% confidence interval 0.1 to 2.2 mm; P = .03). CONCLUSIONS While not as predictive as day 7 cultures, culture positivity at day 3 after starting treatment is a significant predictor of the need for TPK in patients with moderate-to-severe filamentous fungal keratitis. This has applications for risk stratification, and may facilitate earlier consideration of TPK in high-risk patients.",2020,"Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (p=0.03), but was not a statistically significant predictor of perforation, scar size, or final visual acuity.","['Pondicherry with fungal keratitis and visual acuity worse than 20/70 received', 'Patients presenting to Aravind Eye Hospital', 'patients with moderate to severe filamentous fungal keratitis']","['topical natamycin', 'voriconazole or topical therapy alone']","['Visual acuity and scar size', 'fungal keratitis', 'scar size', '3-week and 3-month visual acuity and scar size, corneal perforation and/or the need for therapeutic penetrating keratoplasty (TPK', 'average 3-LogMAR lines worse visual acuity', 'Culture positivity', 'perforation, scar size, or final visual acuity']","[{'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0027444', 'cui_str': 'Natamycin'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0339293', 'cui_str': 'Corneal Perforation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010042', 'cui_str': 'Grafting, Corneal'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",,0.481944,"Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (p=0.03), but was not a statistically significant predictor of perforation, scar size, or final visual acuity.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pickel', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Shivananda', 'Initials': 'S', 'LastName': 'Narayana', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Tiruvengada', 'Initials': 'T', 'LastName': 'Krishnan', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Puja Prativa', 'Initials': 'PP', 'LastName': 'Samantaray', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Redd', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA; The Permanente Medical Group, Redwood City, California, USA. Electronic address: jennifer.rose-nussbaumer@ucsf.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.021'] 678,31613432,Conservative Oxygen Therapy during Mechanical Ventilation in the ICU.,"BACKGROUND Patients who are undergoing mechanical ventilation in the intensive care unit (ICU) often receive a high fraction of inspired oxygen (Fio 2 ) and have a high arterial oxygen tension. The conservative use of oxygen may reduce oxygen exposure, diminish lung and systemic oxidative injury, and thereby increase the number of ventilator-free days (days alive and free from mechanical ventilation). METHODS We randomly assigned 1000 adult patients who were anticipated to require mechanical ventilation beyond the day after recruitment in the ICU to receive conservative or usual oxygen therapy. In the two groups, the default lower limit for oxygen saturation as measured by pulse oximetry (Spo 2 ) was 90%. In the conservative-oxygen group, the upper limit of the Spo 2 alarm was set to sound when the level reached 97%, and the Fio 2 was decreased to 0.21 if the Spo 2 was above the acceptable lower limit. In the usual-oxygen group, there were no specific measures limiting the Fio 2 or the Spo 2 . The primary outcome was the number of ventilator-free days from randomization until day 28. RESULTS The number of ventilator-free days did not differ significantly between the conservative-oxygen group and the usual-oxygen group, with a median duration of 21.3 days (interquartile range, 0 to 26.3) and 22.1 days (interquartile range, 0 to 26.2), respectively, for an absolute difference of -0.3 days (95% confidence interval [CI], -2.1 to 1.6; P = 0.80). The conservative-oxygen group spent more time in the ICU with an Fio 2 of 0.21 than the usual-oxygen group, with a median duration of 29 hours (interquartile range, 5 to 78) and 1 hour (interquartile range, 0 to 17), respectively (absolute difference, 28 hours; 95% CI, 22 to 34); the conservative-oxygen group spent less time with an Spo 2 exceeding 96%, with a duration of 27 hours (interquartile range, 11 to 63.5) and 49 hours (interquartile range, 22 to 112), respectively (absolute difference, 22 hours; 95% CI, 14 to 30). At 180 days, mortality was 35.7% in the conservative-oxygen group and 34.5% in the usual-oxygen group, for an unadjusted odds ratio of 1.05 (95% CI, 0.81 to 1.37). CONCLUSIONS In adults undergoing mechanical ventilation in the ICU, the use of conservative oxygen therapy, as compared with usual oxygen therapy, did not significantly affect the number of ventilator-free days. (Funded by the Health Research Council of New Zealand; ICU-ROX Australian and New Zealand Clinical Trials Registry number, ACTRN12615000957594.).",2020,"The number of ventilator-free days did not differ significantly between the conservative-oxygen group and the usual-oxygen group, with a median duration of 21.3 days (interquartile range, 0 to 26.3) and 22.1 days (interquartile range, 0 to 26.2), respectively, for an absolute difference of -0.3 days (95% confidence interval [CI], -2.1 to 1.6; P = 0.80).","['1000 adult patients who were anticipated to require mechanical ventilation beyond the day after recruitment in the ICU to receive', 'adults undergoing', 'Patients who are undergoing mechanical ventilation in the intensive care unit (ICU']","['conservative or usual oxygen therapy', 'Conservative Oxygen Therapy', 'mechanical ventilation']","['number of ventilator-free days from randomization until day 28', 'oxygen saturation', 'number of ventilator-free days', 'mortality']","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",1000.0,0.224172,"The number of ventilator-free days did not differ significantly between the conservative-oxygen group and the usual-oxygen group, with a median duration of 21.3 days (interquartile range, 0 to 26.3) and 22.1 days (interquartile range, 0 to 26.2), respectively, for an absolute difference of -0.3 days (95% confidence interval [CI], -2.1 to 1.6; P = 0.80).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'From the Medical Research Institute of New Zealand (D.M., R. Beasley, R.F., C.M., S.M., P.Y.) and the Intensive Care Unit, Wellington Hospital (P.Y.), Wellington, the Intensive Care Unit, Hawkes Bay Hospital, Hastings (R.F.), and the Department of Critical Care Medicine (C.M.) and the Cardiothoracic and Vascular Intensive Care Unit (S.M.), Auckland City Hospital, Auckland - all in New Zealand; the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC (R. Bellomo, M.B., V.K., N.L.), the Intensive Care Unit, Austin Hospital, Heidelberg, VIC (R. Bellomo, G.E.), the University of Melbourne (R. Bellomo, M.B., A.D.) and the Intensive Care Unit, Royal Melbourne Hospital (A.D.), Parkville, VIC, the Division of Critical Care and Trauma, George Institute for Global Health, Sydney (S.F.), the Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW (S.F.), the Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA (E.L.), the Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW (R.P.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (R.P.) - all in Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1903297'] 679,30823822,Can perceptual training alter the effect of visual biofeedback in speech-motor learning?,"Recent work showing that a period of perceptual training can modulate the magnitude of speech-motor learning in a perturbed auditory feedback task could inform clinical interventions or second-language training strategies. The present study investigated the influence of perceptual training on a clinically and pedagogically relevant task of vocally matching a visually presented speech target using visual-acoustic biofeedback. Forty female adults aged 18-35 yr received perceptual training targeting the English /æ-ɛ/ contrast, randomly assigned to a condition that shifted the perceptual boundary toward either /æ/ or /ɛ/. Participants were then asked to produce the word head while modifying their output to match a visually presented acoustic target corresponding with a slightly higher first formant (F1, closer to /æ/). By analogy to findings from previous research, it was predicted that individuals whose boundary was shifted toward /æ/ would also show a greater magnitude of change in the visual biofeedback task. After perceptual training, the groups showed the predicted difference in perceptual boundary location, but they did not differ in their performance on the biofeedback matching task. It is proposed that the explicit versus implicit nature of the tasks used might account for the difference between this study and previous findings.",2019,"After perceptual training, the groups showed the predicted difference in perceptual boundary location, but they did not differ in their performance on the biofeedback matching task.",['Forty female adults aged 18-35\u2009yr received'],"['perceptual training on a clinically and pedagogically relevant task of vocally matching a visually presented speech target using visual-acoustic biofeedback', 'perceptual training', 'perceptual training targeting the English /æ-ɛ/ contrast, randomly assigned to a condition that shifted the perceptual boundary toward either /æ/ or /ɛ']",['perceptual boundary location'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0556503', 'cui_str': 'Perceptual training (regime/therapy)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]","[{'cui': 'C0450429', 'cui_str': 'Location (attribute)'}]",40.0,0.0229353,"After perceptual training, the groups showed the predicted difference in perceptual boundary location, but they did not differ in their performance on the biofeedback matching task.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Klaus', 'Affiliation': 'Gallatin School of Individualized Study, New York University, 1 Washington Place, New York, New York 10003, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lametti', 'Affiliation': 'Department of Psychology, Acadia University, Horton Hall, 18 University Avenue, Wolfville, Nova Scotia, B4P 2R6, Canada.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Shiller', 'Affiliation': ""École d'orthophonie et d'audiologie, Université de Montréal, C.P. 6128, succursale Centre-ville, Montreal, Quebec, H3C 3J7, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McAllister', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}]",The Journal of the Acoustical Society of America,['10.1121/1.5089218'] 680,31958280,Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial.,"OBJECTIVES Anti-drug antibodies (ADA) are responsible for decreased adalimumab efficacy in axial spondyloarthritis (SpA). We aimed to evaluate the ability of methotrexate (MTX) to decrease adalimumab immunisation. METHODS A total of 110 patients eligible to receive adalimumab 40 mg subcutaneously (s.c.) every other week were randomised (1:1 ratio) to receive, 2 weeks before adalimumab (W-2) and weekly, MTX 10 mg s.c. (MTX+) or not (MTX-). ADA detection and adalimumab serum concentration were assessed at weeks 4 (W4), 8 (W8), 12 (W12) and 26 (W26) after starting adalimumab (W0). The primary outcome was the proportion of patients with ADA at W26. Four years after the study completion, we retrospectively analysed adalimumab maintenance in relation with MTX co-treatment duration. RESULTS We analysed data for 107 patients (MTX+; n=52; MTX-; n=55). ADA were detected at W26 in 39/107 (36.4%) patients: 13/52 (25%) in the MTX+ group and 26/55 (47.3%) in the MTX- group (p=0.03). Adalimumab concentration was significantly higher in the MTX+ than MTX- group at W4, W8, W12 and W26. The two groups did not differ in adverse events or efficacy. In the follow-up study, MTX co-treatment >W26 versus no MTX or ≤W26 was significantly associated with adalimumab long-term maintenance (p=0.04). CONCLUSION MTX reduces the immunogenicity and ameliorate the pharmacokinetics of adalimumab in axial SpA. A prolonged co-treatment of MTX>W26 seems to increase adalimumab long-term maintenance.",2020,"Adalimumab concentration was significantly higher in the MTX+ than MTX- group at W4, W8, W12 and W26.","['axial spondyloarthritis', 'axial SpA', '110 patients eligible to receive', '107 patients (MTX+; n=52; MTX-; n=55']","['adalimumab 40\u2009mg subcutaneously (s.c', 'adalimumab (W-2) and weekly, MTX', 'Methotrexate', 'adalimumab', 'methotrexate (MTX', 'MTX', 'MTX co-treatment duration', 'MTX+) or not (MTX']","['adverse events or efficacy', 'ADA detection and adalimumab serum concentration', 'proportion of patients with ADA', 'Adalimumab concentration', 'ADA']","[{'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",110.0,0.111152,"Adalimumab concentration was significantly higher in the MTX+ than MTX- group at W4, W8, W12 and W26.","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Ducourau', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Rispens', 'Affiliation': 'Landsteiner Laboratory, Sanquin Research, Amsterdam, Netherlands.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Samain', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Department of Rheumatology, CH du Mans, Le Mans, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Le Guilchard', 'Affiliation': 'Department of Rheumatology, CH de Blois, Blois, France.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Andras', 'Affiliation': 'Department of Rheumatology, CH de Blois, Blois, France.'}, {'ForeName': 'Aleth', 'Initials': 'A', 'LastName': 'Perdriger', 'Affiliation': 'Department of Rheumatology, CHRU de Rennes, Rennes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': ""Department of Rheumatology, CHR d'Orléans, Orléans, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Department of Rheumatology, CH de Saint-Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Cormier', 'Affiliation': 'Department of Rheumatology, CHD Vendée, La Roche-sur-Yon, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Armingeat', 'Affiliation': 'Department of Rheumatology, CH de Saint-Nazaire, Saint-Nazaire, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Devauchelle-Pensec', 'Affiliation': 'Department of Rheumatology, Université de Brest, Inserm UMR1227 LBAI, CHRU de Brest, Brest, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gervais', 'Affiliation': 'Department of Rheumatology, CHRU de Poitiers, Poitiers, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Le Goff', 'Affiliation': 'Department of Rheumatology, CHRU de Nantes, Nantes, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'de Vries', 'Affiliation': 'Biologicals Lab, Sanquin Diagnostic Services, Amsterdam, Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Piver', 'Affiliation': 'Department of Biochemistry, University of Tours, Inserm U 1259, CHRU de Tours, Tours, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Paintaud', 'Affiliation': 'Department of Pharmacology-Toxicology, University of Tours, EA GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Desvignes', 'Affiliation': 'Department of Pharmacology-Toxicology, University of Tours, EA GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ternant', 'Affiliation': 'Department of Pharmacology-Toxicology, University of Tours, EA GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Watier', 'Affiliation': 'Department of Immunology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Mulleman', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France denis.mulleman@univ-tours.fr.'}]",RMD open,['10.1136/rmdopen-2019-001047'] 681,32071186,Acute rule-out of non-ST-segment elevation acute coronary syndrome in the (pre)hospital setting by HEART score assessment and a single point-of-care troponin: rationale and design of the ARTICA randomised trial.,"INTRODUCTION Because of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective. METHODS AND ANALYSIS The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months. ETHICS AND DISSEMINATION This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses. TRIAL REGISTRATION NUMBER Netherlands Trial Register (NL7148).",2020,"The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement.","['low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement', '866 patients will be included']",['ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value'],['cost-effectiveness'],"[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0522483', 'cui_str': 'Patient suspected of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1141947', 'cui_str': 'Troponin T measurement'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1141947', 'cui_str': 'Troponin T measurement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",866.0,0.1115,"The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement.","[{'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Camaro', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Cramer', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Damman', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Pierre M', 'Initials': 'PM', 'LastName': 'van Grunsven', 'Affiliation': 'Ambulancezorg, Veiligheidsregio Gelderland-Zuid, Nijmegen, The Netherlands.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Adang', 'Affiliation': 'Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Giesen', 'Affiliation': 'Scientific Institute for Quality of Healthcare, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Rutten', 'Affiliation': 'Scientific Institute for Quality of Healthcare, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Ouwendijk', 'Affiliation': 'Huisartsenpost Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc E R', 'Initials': 'MER', 'LastName': 'Gomes', 'Affiliation': 'Cardiology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands niels.vanroyen@radboudumc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-034403'] 682,32071281,Treat-to-target in PsA: methods and necessity.,"With increasing recognition of the high burden and impact of psoriatic arthritis (PsA) and the growing number of therapeutic options, there has been an intensifying focus on treatment strategy in recent years. In 2015, the Tight Control of Psoriatic Arthritis study confirmed the clinical benefit of using a treat-to-target approach in PsA. This randomised controlled trial found benefits in both arthritis and psoriasis disease activity as well as lower disease impact reported by patients, although participants allocated to tight control experienced a higher rate of serious adverse events. European and international recommendations support the use of a treat-to-target approach in PsA and have offered specific advice on how to do this using outcomes such as the minimal disease activity criteria. However, implementation of this approach in routine practice is low, with real-world data highlighting undertreatment as a result. Recent qualitative work with physicians in the UK has helped researchers to understand the barriers to implementation of treat-to-target in PsA. We now need to address these barriers, provide education and support to non-specialist clinicians in routine practice, and aid the translation of optimal care to the clinic.",2020,"This randomised controlled trial found benefits in both arthritis and psoriasis disease activity as well as lower disease impact reported by patients, although participants allocated to tight control experienced a higher rate of serious adverse events.",[],[],[],[],[],[],,0.0579559,"This randomised controlled trial found benefits in both arthritis and psoriasis disease activity as well as lower disease impact reported by patients, although participants allocated to tight control experienced a higher rate of serious adverse events.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dures', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Shepperd', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Rheumatology, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Health and Applied Sciences, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, Coventry, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walsh', 'Affiliation': 'Centre for Health and Clinical Research, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK laura.coates@ndorms.ox.ac.uk.'}]",RMD open,['10.1136/rmdopen-2019-001083'] 683,32075823,"Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640).","INTRODUCTION Migrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden. METHODS AND ANALYSIS A randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women's ratings of the intrapartum care experiences and postnatal well-being are assessed at 6-8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms. ETHICS AND DISSEMINATION The study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2). TRIAL REGISTRATION NUMBER NCT03461640; Pre-results.",2020,Women's ratings of the intrapartum care experiences and postnatal well-being are assessed at 6-8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale.,"['migrant women during labour and birth', 'migrant women giving birth in Sweden', '200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth']","['control group using intention-to-treat analyses', 'Community-based doula support', 'Community-based doulas (CBDs']",[],"[{'cui': 'C0026093', 'cui_str': 'Migrants'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337847', 'cui_str': 'Somalis (ethnic group)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2936640', 'cui_str': 'Doulas'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],200.0,0.227975,Women's ratings of the intrapartum care experiences and postnatal well-being are assessed at 6-8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale.,"[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Schytt', 'Affiliation': 'Centre for Clinical Research Dalarna, Uppsala University, Falun, Sweden Erica.Schytt@ltdalarna.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wahlberg', 'Affiliation': ""Women's and Children's health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Eltayb', 'Affiliation': ""Women's and Children's health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Small', 'Affiliation': ""Women's and Children's health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Tsekhmestruk', 'Affiliation': ""Women's and Children's health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': ""Women's and Children's health, Karolinska Institute, Stockholm, Sweden.""}]",BMJ open,['10.1136/bmjopen-2019-031290'] 684,32075826,Placebos in primary care? a nominal group study explicating UK GP and patient views of six theoretically plausible models of placebo practice.,"OBJECTIVES To better understand which theoretically plausible placebogenic techniques might be acceptable in UK primary care. DESIGN A qualitative study using nominal group technique and thematic analysis. Participants took part in audio-recorded face-to-face nominal groups in which the researcher presented six scenarios describing the application in primary care of theoretically plausible placebogenic techniques: (1) Withholding side effects information, (2) Monitoring, (3) General practitioner (GP) endorsement, (4) Idealised consultation, (5) Deceptive placebo pills and (6) Open-label placebo pills. Participants voted on whether they thought each scenario was acceptable in practice and discussed their reasoning. Votes were tallied and discussions transcribed verbatim. SETTING Primary care in England. PARTICIPANTS 21 GPs in four nominal groups and 20 'expert patients' in five nominal groups. RESULTS Participants found it hard to decide which practices were acceptable and spoke about needing to weigh potential symptomatic benefits against the potential harms of lost trust eroding the therapeutic relationship. Primary care patients and doctors felt it was acceptable to harness placebo effects in practice by patient self-monitoring (scenario 2), by the GP expressing a strongly positive belief in a therapy (scenario 3) and by conducting patient-centred, empathic consultations (scenario 4). Deceptive placebogenic practices (scenarios 1 and 5) were unacceptable to most groups. Patient and GP groups expressed a diverse range of opinions about open-label placebo pills. CONCLUSIONS Attempts to harness placebo effects in UK primary care are more likely to be accepted and implemented if they focus on enhancing positive patient-centred communication and empathic relationships. Using placebos deceptively is likely to be unacceptable to both GPs and patients. Open-label placebos also do not have clear support; they might be acceptable to some doctors and patients in very limited circumstances-but further evidence, clear information and guidance would be needed.",2020,"Primary care patients and doctors felt it was acceptable to harness placebo effects in practice by patient self-monitoring (scenario 2), by the GP expressing a strongly positive belief in a therapy (scenario 3) and by conducting patient-centred, empathic consultations (scenario 4).","[""21 GPs in four nominal groups and 20 'expert patients' in five nominal groups"", 'Primary care in England']","['placebos', 'placebo practice', 'audio-recorded face-to-face nominal groups in which the researcher presented six scenarios describing the application in primary care of theoretically plausible placebogenic techniques: (1) Withholding side effects information, (2) Monitoring, (3) General practitioner (GP) endorsement, (4) Idealised consultation, (5) Deceptive placebo pills and (6) Open-label placebo pills', 'Placebos']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",[],21.0,0.0368253,"Primary care patients and doctors felt it was acceptable to harness placebo effects in practice by patient self-monitoring (scenario 2), by the GP expressing a strongly positive belief in a therapy (scenario 3) and by conducting patient-centred, empathic consultations (scenario 4).","[{'ForeName': 'Mohana', 'Initials': 'M', 'LastName': 'Ratnapalan', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Coghlan', 'Affiliation': 'ACT Works Ltd, Portsmouth, UK.'}, {'ForeName': 'Mengxin', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Centre of Global Mental Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Everitt', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lewith', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Bishop', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK F.L.Bishop@soton.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-032524'] 685,32102803,Neural and clinical changes of cognitive behavioural therapy versus talking control in patients with major depression: a study protocol for a randomised clinical trial.,"INTRODUCTION While major depression causes substantial distress and impairment for affected individuals and society, the effectiveness of cognitive behavioural therapy (CBT) in treating the condition has been established. However, the therapeutic mechanism underlying the efficacy of CBT remains unknown. This study aimed to describe a protocol for a randomised controlled trial that will measure the CBT-induced clinical and neural changes in patients with non-psychotic major depression. METHODS AND ANALYSIS The current study is a 16-week assessor-blinded, randomised, parallel-group trial with a 12-month follow-up as part of usual depression care at an outpatient clinic. Patients aged 20-69 years with major depressive disorder will be randomly assigned to receive either CBT in addition to their usual treatment or talking control in addition to their usual treatment for 16 weeks. The primary outcome is the functional changes in the brain areas that have been associated with future-oriented thinking at 16 weeks; secondary outcomes include changes in functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life. The intention-to-treat analysis will be used. ETHICS AND DISSEMINATION All protocols and the informed consent form are compliant with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethical Review Committees at the Keio University School of Medicine have approved the study protocol (version 3, 11 September 2017). We will disseminate research findings to scientific and general audiences through national and international conference presentations as well as lay summaries to the general public, including mental health consumer and publications in international peer-reviewed psychiatry and brain imaging journals. TRIAL REGISTRATION NUMBER UMIN Clinical Trials Registry (UMIN000018155); Pre-results.",2020,"The primary outcome is the functional changes in the brain areas that have been associated with future-oriented thinking at 16 weeks; secondary outcomes include changes in functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life.","['patients with major depression', 'Patients aged 20-69 years with major depressive disorder', 'patients with non-psychotic major depression']","['CBT in addition to their usual treatment or talking control', 'cognitive behavioural therapy (CBT', 'cognitive behavioural therapy versus talking control']","['functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.129175,"The primary outcome is the functional changes in the brain areas that have been associated with future-oriented thinking at 16 weeks; secondary outcomes include changes in functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life.","[{'ForeName': 'Nariko', 'Initials': 'N', 'LastName': 'Katayama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan anakagawa@keio.jp.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Kurata', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Mitsuda', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Shigetsugu', 'Initials': 'S', 'LastName': 'Nakao', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Sayuri', 'Initials': 'S', 'LastName': 'Mizuno', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Mire', 'Initials': 'M', 'LastName': 'Ozawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Umeda', 'Affiliation': 'Department of Psychology, Keio University Faculty of Letters, Minato-ku, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Terasawa', 'Affiliation': 'Department of Psychology, Keio University Faculty of Letters, Minato-ku, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Tabuchi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Association of International Arts and Science, Yokohama City University School of Data Science, Yokohama, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-029735'] 686,32102807,Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss.,"OBJECTIVES To examine the acceptability and feasibility of narrative text messages with or without financial incentives to support weight loss for men. DESIGN Individually randomised three-arm feasibility trial with 12 months' follow-up. SETTING Two sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD). PARTICIPANTS Men with obesity (n=105) recruited through community outreach and general practitioner registers. INTERVENTIONS Participants randomised to: (A) narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control. OUTCOMES Acceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data at 3, 6 and 12 months. RESULTS 105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2). Retention at 12 months was 74%. Fewer SMS+I participants (64%) completed 12-month assessments compared with SMS only (79%) and control (83%). Narrative texts were acceptable to many men, but some reported negative reactions. No evidence emerged that level of disadvantage was related to acceptability of narrative texts. Eleven SMS+I participants (31%) successfully met or partially met weight loss targets. The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30). Incentives were acceptable, but improving health was reported as the key motivator for weight loss. All groups lost weight (SMS+I: -2.51 kg (SD=4.94); SMS only: -1.29 kg (SD=5.03); control: -0.86 kg (SD=5.64) at 12 months). CONCLUSIONS This three-arm weight management feasibility trial recruited and retained men from across the socioeconomic spectrum, with the majority from areas of disadvantage, was broadly acceptable to most participants and feasible to deliver. TRIAL REGISTRATION NUMBER NCT03040518.",2020,The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30).,"['engage men with obesity in text message and incentive interventions for weight loss', 'Two sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD', '105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2', 'men', 'Men with obesity (n=105) recruited through community outreach and general practitioner registers', 'Eleven SMS+I participants (31%) successfully met or partially met weight loss targets']","['narrative text messages with or without financial incentives', 'narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control']","['Acceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3178909'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}]",105.0,0.177374,The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30).,"[{'ForeName': 'Stephan U', 'Initials': 'SU', 'LastName': 'Dombrowski', 'Affiliation': 'Department of Kinesiology, University of New Brunswick Fredericton, Fredericton, New Brunswick, Canada stephan.dombrowski@unb.ca.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'van der Pol', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Grindle', 'Affiliation': 'Institute for Health Research and Innovation, University of the Highlands and Islands, Inverness, Highland, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Avenell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carroll', 'Affiliation': 'Mens Health Forum in Ireland, Dublin, Ireland.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Calveley', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Glennie', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Harris', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hapca', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Health Informatics Centre, University of Dundee, Dundee, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kee', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'McKinley', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Skinner', 'Affiliation': 'Division of Psychology, University of Stirling, Stirling, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tod', 'Affiliation': ""Men's Health Forum, London, UK.""}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Hoddinott', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032653'] 687,32102810,Trabeculotomy versus combined trabeculotomy-trabeculectomy for primary congenital glaucoma: study protocol of a randomised controlled trial.,"INTRODUCTION Trabeculotomy and combined trabeculotomy-trabeculectomy (CTT) are major surgical options for primary congenital glaucoma (PCG). However, it is unclear which of these two surgical procedures should be recommended as the optimum first-line treatment for PCG. This trial aims to determine whether the outcomes of trabeculotomy are non-inferior to those of CTT in moderate PCG with a horizontal corneal diameter (HCD) of 12-14 mm. METHODS AND ANALYSIS This is a 3-year, non-inferiority, prospective, randomised controlled trial. We plan to recruite 248 participants (aged ≤3 years) with PCG with an HCD of 12-14 mm from the Department of Glaucoma, Zhongshan Ophthalmic Center, Guangzhou, China. One eye per participant will be randomly (1:1) assigned to receive trabeculotomy or CTT. The primary outcome is the 3-year postoperative success rate in lowering intraocular pressure (IOP), and the secondary clinical outcomes will include IOP reduction, visual acuity, HCD, central corneal thickness, axial length, cup-disc ratio, refractive error and postoperative complications. Data will be analysed by the intention-to-treat principle. ETHICAL APPROVAL AND DISSEMINATION The study protocol has been approved by the ethics committee of Zhongshan Ophthalmic Center (2014MEKY023) and the '5010 Plan' evaluation committee at Sun Yat-Sen University, Guangzhou, China. The results will be disseminated in international academic meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER Chinese Clinical Trial Registry, ChiCTR-IOR-14005588; Date registered: 20 November 2014.",2020,"This trial aims to determine whether the outcomes of trabeculotomy are non-inferior to those of CTT in moderate PCG with a horizontal corneal diameter (HCD) of 12-14 mm. ","['primary congenital glaucoma', 'moderate PCG with a horizontal corneal diameter (HCD) of 12-14 mm', 'primary congenital glaucoma (PCG', '248 participants (aged ≤3 years) with PCG with an HCD of 12-14 mm from the Department of Glaucoma, Zhongshan Ophthalmic Center, Guangzhou, China']","['Trabeculotomy and combined trabeculotomy-trabeculectomy (CTT', 'trabeculotomy or CTT', 'CTT', 'Trabeculotomy', 'combined trabeculotomy-trabeculectomy', 'trabeculotomy']","['3-year postoperative success rate in lowering intraocular pressure (IOP), and the secondary clinical outcomes will include IOP reduction, visual acuity, HCD, central corneal thickness, axial length, cup-disc ratio, refractive error and postoperative complications']","[{'cui': 'C1533041', 'cui_str': 'Primary infantile glaucoma'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0609760', 'cui_str': 'PCG (combination)'}, {'cui': 'C0429515', 'cui_str': 'Horizontal corneal diameter (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0028841', 'cui_str': 'Ocular Hypotony'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",,0.498342,"This trial aims to determine whether the outcomes of trabeculotomy are non-inferior to those of CTT in moderate PCG with a horizontal corneal diameter (HCD) of 12-14 mm. ","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yangfan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiangxi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yingting', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jielei', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China drliuxing@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-032957'] 688,32102812,"How, in what contexts, and why do quality dashboards lead to improvements in care quality in acute hospitals? Protocol for a realist feasibility evaluation.","INTRODUCTION National audits are used to monitor care quality and safety and are anticipated to reduce unexplained variations in quality by stimulating quality improvement (QI). However, variation within and between providers in the extent of engagement with national audits means that the potential for national audit data to inform QI is not being realised. This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet). METHODS AND ANALYSIS Realist evaluation, which involves building, testing and refining theories of how an intervention works, provides an overall framework for this feasibility study. Realist hypotheses that describe how, in what contexts, and why QualDash is expected to provide benefit will be tested across five hospitals. A controlled interrupted time series analysis, using key MINAP and PICANet measures, will provide preliminary evidence of the impact of QualDash, while ethnographic observations and interviews over 12 months will provide initial insight into contexts and mechanisms that lead to those impacts. Feasibility outcomes include the extent to which MINAP and PICANet data are used, data completeness in the audits, and the extent to which participants perceive QualDash to be useful and express the intention to continue using it after the study period. ETHICS AND DISSEMINATION The study has been approved by the University of Leeds School of Healthcare Research Ethics Committee. Study results will provide an initial understanding of how, in what contexts, and why quality dashboards lead to improvements in care quality. These will be disseminated to academic audiences, study participants, hospital IT departments and national audits. If the results show a trial is feasible, we will disseminate the QualDash software through a stepped wedge cluster randomised trial.",2020,"This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet). ",[],['QualDash'],[],[],[],[],,0.129498,"This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet). ","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randell', 'Affiliation': 'Faculty of Health Studies, University of Bradford, Bradford, West Yorkshire, UK r.randell@bradford.ac.uk.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Alvarado', 'Affiliation': 'Wolfson Centre for Applied Health Research, Bradford, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'McVey', 'Affiliation': 'Wolfson Centre for Applied Health Research, Bradford, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Greenhalgh', 'Affiliation': 'Sociology and Social Policy, University of Leeds, Leeds, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'West', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Parslow', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Keen', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Elshehaly', 'Affiliation': 'Faculty of Engineering & Informatics, University of Bradford, Bradford, UK.'}, {'ForeName': 'Roy A', 'Initials': 'RA', 'LastName': 'Ruddle', 'Affiliation': 'School of Computing, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lake', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Mamas', 'Initials': 'M', 'LastName': 'Mamas', 'Affiliation': 'Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feltbower', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Dowding', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, Greater Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033208'] 689,29688123,A Randomized Trial of Early Endovenous Ablation in Venous Ulceration.,"BACKGROUND Venous disease is the most common cause of leg ulceration. Although compression therapy improves venous ulcer healing, it does not treat the underlying causes of venous hypertension. Treatment of superficial venous reflux has been shown to reduce the rate of ulcer recurrence, but the effect of early endovenous ablation of superficial venous reflux on ulcer healing remains unclear. METHODS In a trial conducted at 20 centers in the United Kingdom, we randomly assigned 450 patients with venous leg ulcers to receive compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until 6 months after randomization if the ulcer was unhealed (deferred-intervention group). The primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life. RESULTS Patient and clinical characteristics at baseline were similar in the two treatment groups. The time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group; more patients had healed ulcers with early intervention (hazard ratio for ulcer healing, 1.38; 95% confidence interval [CI], 1.13 to 1.68; P=0.001). The median time to ulcer healing was 56 days (95% CI, 49 to 66) in the early-intervention group and 82 days (95% CI, 69 to 92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks was 85.6% in the early-intervention group and 76.3% in the deferred-intervention group. The median ulcer-free time during the first year after trial enrollment was 306 days (interquartile range, 240 to 328) in the early-intervention group and 278 days (interquartile range, 175 to 324) in the deferred-intervention group (P=0.002). The most common procedural complications of endovenous ablation were pain and deep-vein thrombosis. CONCLUSIONS Early endovenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and more time free from ulcers than deferred endovenous ablation. (Funded by the National Institute for Health Research Health Technology Assessment Program; EVRA Current Controlled Trials number, ISRCTN02335796 .).",2018,Early endovenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and more time free from ulcers than deferred endovenous ablation.,"['20 centers in the United Kingdom, we randomly assigned 450 patients with venous leg ulcers to receive', 'Venous Ulceration']","['compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation', 'compression therapy', 'Early Endovenous Ablation']","['healed ulcers', 'faster healing of venous leg ulcers', 'pain and deep-vein thrombosis', 'median time to ulcer healing', 'rate of ulcer recurrence', 'rate of ulcer healing', 'time to ulcer healing', 'rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time', 'health-related quality of life', 'venous ulcer healing', 'median ulcer-free time']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0333293', 'cui_str': 'Healing ulcer (morphologic abnormality)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}]",450.0,0.0596762,Early endovenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and more time free from ulcers than deferred endovenous ablation.,"[{'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Heatley', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Cullum', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Epstein', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nyamekye', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Poskitt', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renton', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'From Cambridge University Hospitals NHS Foundation Trust, Cambridge (M.S.G.), the Department of Surgery and Cancer (M.S.G., F.H., A.H.D.) and Imperial Clinical Trials Unit (X.L., J.W.), Imperial College London, London, University of Birmingham, Birmingham (A.B.), Gloucestershire Hospitals NHS Foundation Trust, Gloucester (R.B., K.R.P.), the Medical Research Council Population Health Research Unit and the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford (R.B.), University of Manchester, Manchester (N.C.), Worcestershire Acute Hospitals NHS Trust, Worcester (I.N.), North West London Hospitals NHS Trust, Harrow (S.R.), and University of Warwick, Coventry (J.W.) - all in the United Kingdom; and the University of Granada, Granada, Spain (D.M.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1801214'] 690,32167784,Primary Care Management of Children with Attention-Deficit/Hyperactivity Disorder Appears More Assertive Following Brief Psychiatric Intervention Compared with Single Session Consultation.,"Objectives: We examined primary care providers' (PCPs') management of attention-deficit/hyperactivity disorder (ADHD) during and following families' participation in two arms of the Children's ADHD Telemental Health Treatment Study. We hypothesized that more intensive treatment during the trial would show an ""after-effect"" with more assertive PCPs' management during short term follow-up. Methods: We conducted a pragmatic follow-up of PCPs' management of children with ADHD who had been randomized to two service delivery models. In the Direct Service Model, psychiatrists provided six sessions over 22 weeks of pharmacotherapy followed by behavior training. In the Consultation Model, psychiatrists provided a single-session consultation and made treatment recommendations to PCPs who implemented these recommendations at their discretion for 22 weeks. At the end of the trial, referring PCPs for both service delivery models resumed ADHD treatment for 10 weeks. We performed intent-to-treat analysis using all 223 original participants. We applied linear regression models on continuous outcomes, Poisson regression models on count outcomes, and logistic regression models to binary outcomes. Missing data were addressed through imputations. Results: Participants in the Direct Service Model had more ADHD visits than those in the Consultation Model across the full 32 weeks (mean = 7.05 visits vs. 3.36 visits; adjusted rate ratio = 2.1 [1.85-2.38]; p  < 0.0001). During follow-up, participants in the DSM were more likely to be taking ADHD-related medications (82% vs. 61%; adjusted odds ratio = 2.44 [1.24-4.81], p  = 0.01). At 32 weeks, participants in the Direct Service Model had higher stimulant dosages (adjusted difference = 5.64 [0.12-11.15] mg; p  = 0.046). Conclusion: These results from a pragmatic follow-up of a randomized trial suggest an ""after-effect"" for brief intensive treatment in the Direct Service Model on the short term follow-up management of ADHD in primary care.",2020,had more ADHD visits than those in the Consultation Model across the full 32 weeks,"['223 original participants', 'children with ADHD who had been randomized to two service delivery models', 'Results: Participants in the Direct Service Model', 'Children with Attention-Deficit/Hyperactivity Disorder']","['Psychiatric Intervention', ""primary care providers' (PCPs') management of attention-deficit/hyperactivity disorder (ADHD""]",['ADHD visits'],"[{'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}]",,0.0557932,had more ADHD visits than those in the Consultation Model across the full 32 weeks,"[{'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Rockhill', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'L Lee', 'Initials': 'LL', 'LastName': 'Carlisle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Vander Stoep', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'French', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Myers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0013'] 691,32167792,Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial.,"Objectives: To evaluate the clinical and neurochemical effects of 12-week fish oil, a source of omega-3 polyunsaturated fatty acids ( n -3 PUFAs), in depressed adolescents with a family history of bipolar I disorder. Methods: Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of ≥40, and at least one biological parent with bipolar I disorder were randomized to double-blind treatment with fish oil (2100 mg/day) or placebo for 12 weeks. The primary outcome measure was change in CDRS-R total score, and secondary outcomes measures were change in manic symptoms (Young Mania Rating Scale), global symptom and functioning measures (Clinical Global Impression-Severity [CGI-S] /CGI Improvement [CGI-I], Children's Global Assessment Scale, and Child Behavior Checklist), safety and laboratory measures, and anterior cingulate cortex (ACC) and bilateral ventrolateral prefrontal cortex neurometabolite concentrations using proton magnetic resonance spectroscopy at 4 T. Results: Fifty-six patients were randomized, and 42 completed the 12-week trial (placebo: n  = 21; fish oil, n  = 21). Subjects randomized to fish oil, but not placebo, exhibited a significant baseline to endpoint increase in erythrocyte n -3 PUFAs. Reductions in CDRS-R scores did not differ between treatment groups ( p  = 0.15), and similar remission ( p  = 0.58) and response ( p  = 0.77) rates were observed. Fish oil produced a significantly greater decrease in CGI-S ( p  = 0.0042) and CGI-I ( p  = 0.036) scores compared with placebo. Baseline to endpoint change in ACC creatine ( p  = 0.004) and ACC choline (Cho) ( p  = 0.024) differed significantly between groups. Baseline ACC Cho levels were inversely correlated with baseline and baseline to endpoint change in CDRS-R scores, and baseline to endpoint change in ACC Cho correlated with baseline-endpoint change in CDRS-R scores and n -3 PUFA. There were no group differences in safety and tolerability ratings or laboratory measures. Conclusions: Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement. Associations among ACC Cho levels, depression symptom severity, and n -3 PUFA warrant additional investigation.",2020,"Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement.","['Adolescents at High Risk for Bipolar I Disorder', 'Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of ≥40, and at least one biological parent with bipolar I disorder', 'depressed adolescents with a family history of bipolar I disorder']","['12-week fish oil, a source of omega-3 polyunsaturated fatty acids ( n -3 PUFAs', 'CGI', 'Fish oil monotherapy', 'placebo', 'fish oil', 'Fish Oil Monotherapy', 'Placebo', 'placebo: n \u2009=\u200921; fish oil, n \u2009=\u200921']","['CDRS-R scores', 'depressive symptoms', 'CGI', 'safety and tolerability ratings or laboratory measures', 'Baseline ACC Cho levels', 'change in CDRS-R total score', 'manic symptoms (Young Mania Rating Scale), global symptom and functioning measures (Clinical Global Impression-Severity [CGI-S', 'Depression and Prefrontal Neurochemistry', ""Improvement [CGI-I], Children's Global Assessment Scale, and Child Behavior Checklist), safety and laboratory measures, and anterior cingulate cortex (ACC) and bilateral ventrolateral prefrontal cortex neurometabolite concentrations"", 'ACC creatine', 'ACC choline (Cho', 'erythrocyte n -3 PUFAs', 'CGI-S', 'similar remission']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2363919', 'cui_str': 'Childhood depression'}, {'cui': 'C0222045'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337465', 'cui_str': 'Natural parent (person)'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0027820', 'cui_str': 'Neurochemistry'}, {'cui': 'C3472495', 'cui_str': ""Children's global assessment scale""}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",56.0,0.325419,"Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement.","[{'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Tallman', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Welge', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'L Rodrigo', 'Initials': 'LR', 'LastName': 'Patino', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0124'] 692,32051304,Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial.,"OBJECTIVES We developed a complex intervention called DECIDE (Computerise D d EC is I onal support for suboptimally controlle D typ E 2 D iabetes mellitus in Irish General Practice) which used a clinical decision support system to address clinical inertia and support general practitioner (GP) intensification of treatment for adults with suboptimally controlled type2 diabetes mellitus (T2DM). The current study explored the feasibility and potential impact of DECIDE. DESIGN A pilot cluster randomised controlled trial. SETTING Conducted in 14 practices in Irish General Practice. PARTICIPANTS The DECIDE intervention was targeted at GPs. They applied DECIDE to patients with suboptimally controlled T2DM, defined as a glycated haemoglobin (HbA1c) ≥70 mmol/mol and/or blood pressure ≥150/95 mmHg. INTERVENTION The intervention incorporated training and a web-based clinical decision support system which supported; (i) medication intensification actions; and (ii) non-pharmacological actions to support care. Control practices delivered usual care. PRIMARY AND SECONDARY OUTCOME MEASURES Feasibility and acceptability was determined using thematic analysis of semi-structured interviews with GPs, combined with data from the DECIDE website. Clinical outcomes included HbA1c, medication intensification, blood pressure and lipids. RESULTS We recruited 14 practices and 134 patients. At 4-month follow-up, all practices and 114 patients were followed up. GPs reported finding decision support helpful navigating increasingly complex medication algorithms. However, the majority of GPs believed that the target patient group had poor engagement with GP and hospital services for a range of reasons. At follow-up, there was no difference in glycaemic control (-3.6 mmol/mol (95% CI -11.2 to 4.0)) between intervention and control groups or in secondary outcomes including, blood pressure, total cholesterol, medication intensification or utilisation of services. Continuation criteria supported proceeding to a definitive randomised trial with some modifications. CONCLUSION The DECIDE study was feasible and acceptable to GPs but wider impacts on glycaemic and blood pressure control need to be considered for this patient population going forward. TRIAL REGISTRATION NUMBER ISRCTN69498919.",2020,"At follow-up, there was no difference in glycaemic control (-3.6 mmol/mol (95% CI -11.2 to 4.0)) between intervention and control groups or in secondary outcomes including, blood pressure, total cholesterol, medication intensification or utilisation of services.","['Conducted in 14 practices in Irish General Practice', 'patients with suboptimally controlled T2DM, defined as a glycated haemoglobin (HbA1c) ≥70\u2009mmol/mol and/or blood pressure ≥150/95\u2009mmHg', 'We recruited 14 practices and 134 patients', 'adults with suboptimally controlled type2 diabetes mellitus (T2DM']","['EC', 'intervention incorporated training and a web-based clinical decision support system which supported; (i) medication intensification actions; and (ii) non-pharmacological actions to support care']","['blood pressure, total cholesterol, medication intensification or utilisation of services', 'glycaemic control', 'HbA1c, medication intensification, blood pressure and lipids']","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",,0.103936,"At follow-up, there was no difference in glycaemic control (-3.6 mmol/mol (95% CI -11.2 to 4.0)) between intervention and control groups or in secondary outcomes including, blood pressure, total cholesterol, medication intensification or utilisation of services.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Murphy', 'Affiliation': 'Department of General Practice, HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, Ireland markmurphy@rcsi.ie.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'McSharry', 'Affiliation': 'Health Behaviour Change Research Group, School of Psycology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Health Behaviour Change Research Group, School of Psycology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Boland', 'Affiliation': 'Department of General Practice, HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Corrigan', 'Affiliation': 'Department of General Practice, HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Paddy', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'School of Business and Economics, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fahey', 'Affiliation': 'Department of General Practice, HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Department of General Practice, HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, Ireland.'}]",BMJ open,['10.1136/bmjopen-2019-032594'] 693,32051312,Tackling statin intolerance with n-of-1 trials (TaSINI) in primary care: protocol for a feasibility randomised trial to increase statin adherence.,"INTRODUCTION Statins reduce the incidence of cardiovascular disease (CVD) and cause few adverse effects. Half of patients prescribed statins discontinue treatment due to perceived intolerance. Placebo-controlled (blinded) n-of-1 trials have shown people with perceived intolerance that the statin does not cause adverse events and most resume treatment. However, blinded n-of-1 trials are impractical to deliver in routine practice. Tackling Statin Intolerance using n-of-1 trials (TaSINI) will test the feasibility of a general practitioner (GP)-delivered behavioural intervention endorsing an unblinded n-of-1 trial to increase adherence to statins relative to usual care. METHODS AND ANALYSIS TaSINI is a feasibility randomised controlled trial with a nested qualitative substudy. Ninety primary care patients who have discontinued statins due to intolerance or refused treatment will be randomised to an unblinded n-of-1 trial, a blinded n-of-1 trial (positive control) or usual care (negative control). Participants randomised to usual care will be advised to take statin therapy to prevent CVD. In both n-of-1 trial arms, GPs will deliver a behaviourally informed intervention that accessibly explains the benefits of statins, the prevalence of adverse effects and endorse the benefit of experimenting with medication. Participants will alternate between 4 weeks of medication and no medication (unblinded arm) or randomly sorted active and placebo (blinded arm) and will record adherence, symptoms and symptom attributions throughout. After 6 months, GPs will feedback symptom data during active/inactive treatment periods. All participants will be asked if they would like to initiate statin treatment. Measures of feasibility will be met if 4% of invited patients enrol, 50% of participants randomised to n-of-1 trials engage with the experiment and 25% more participants initiate statin in the unblinded n-of-1 arm than in usual care. ETHICS AND DISSEMINATION This study has been granted ethical approval by North of Scotland Research Ethics Service. The results will be written up for publication and show whether to progress to an effectiveness trial where the primary outcome would be differences in low-density lipoprotein concentration.",2020,"Tackling Statin Intolerance using n-of-1 trials (TaSINI) will test the feasibility of a general practitioner (GP)-delivered behavioural intervention endorsing an unblinded n-of-1 trial to increase adherence to statins relative to usual care. ","['Ninety primary care patients who have discontinued statins due to intolerance or refused treatment', 'primary care']","['Placebo', 'randomly sorted active and placebo', 'blinded n-of-1 trial (positive control) or usual care (negative control', 'general practitioner (GP)-delivered behavioural intervention']",['low-density lipoprotein concentration'],"[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",90.0,0.454544,"Tackling Statin Intolerance using n-of-1 trials (TaSINI) will test the feasibility of a general practitioner (GP)-delivered behavioural intervention endorsing an unblinded n-of-1 trial to increase adherence to statins relative to usual care. ","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Tudor', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK kate.tudor@phc.ox.ac.uk.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Howick', 'Affiliation': 'Faculty of Philosophy, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': 'Bicester Health Centre, Bicester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033070'] 694,32051317,Platelet rich plasma versus placebo for the management of Achilles tendinopathy: protocol for the UK study of Achilles tendinopathy management (ATM) multi-centre randomised trial.,"INTRODUCTION In the UK, 150 000 people every year experience mid-substance Achilles tendinopathy. Typically patients are offered a range of treatment options such as exercise, electrotherapy, injections and surgery. With large variations in current practice, there is a pressing need to establish which treatments are effective and which are not. This is the protocol for a multi-centre randomised trial of platelet rich plasma (PRP) versus placebo injection for patients with Achilles tendinopathy. METHODS AND ANALYSIS Adult patients with mid-substance Achilles tendinopathy for longer than 3 months will be screened. Randomisation will be on a 1:1 basis, stratified by centre and bilateral presentation. Participants will be allocated to either a single PRP injection or placebo injection. A minimum of 240 patients will be recruited into the study; this number will provide 90% power to detect a difference of 12 points in Victorian Institute of Sport Assessment-Achilles score at 6 months. Quality of life, pain and complications data will be collected at baseline, 2-week, 3-month and 6-month post-randomisation. The differences between treatment groups will be assessed on an intention-to-treat basis. ETHICS, REGISTRATION AND DISSEMINATION This trial was funded by Versus Arthritis and commenced on 1 September 2015 (Versus Arthritis 20831). National Research Ethic Committee approved this study on 30 October 2015 (15/WM/0359). It was registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry with reference number ISRCTN 13254422 on 28 October 2015. The first site opened to recruitment on 27 April 2016 and the trial was in active recruitment at the point of submitting the protocol paper. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice with regard to the treatment of Achilles tendinopathy.",2020,"This is the protocol for a multi-centre randomised trial of platelet rich plasma (PRP) versus placebo injection for patients with Achilles tendinopathy. ","['240 patients', 'Adult patients with mid-substance Achilles tendinopathy for longer than 3\u2009months will be screened', 'patients with Achilles tendinopathy', '30 October 2015 (15/WM/0359']","['PRP injection or placebo injection', 'Platelet rich plasma versus placebo', 'platelet rich plasma (PRP) versus placebo injection']","['Victorian Institute of Sport Assessment-Achilles score', 'Quality of life, pain and complications data']","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C3840085', 'cui_str': 'Disorder of Achilles tendon (disorder)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.397257,"This is the protocol for a multi-centre randomised trial of platelet rich plasma (PRP) versus placebo injection for patients with Achilles tendinopathy. ","[{'ForeName': 'Rebecca Samantha', 'Initials': 'RS', 'LastName': 'Kearney', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK R.S.Kearney@Warwick.ac.uk.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Trauma and Orthopaedic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034076'] 695,32060155,"Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study.","INTRODUCTION Stomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. METHODS AND ANALYSIS In this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10 mL 0.1 mg/mL; swish for 2 min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events. ETHICS AND DISSEMINATION All participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001). TRIAL REGISTRATION NUMBER UMIN Clinical Trials Registry (UMIN000030489).",2020,The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups.,"['women with breast cancer', '120 women with early breast cancer undergoing chemotherapy to use of a', 'patients undergoing chemotherapy for breast cancer', 'patients with early breast cancer']","['control group will receive chemotherapy and oral care', 'chemotherapy-induced stomatitis', 'dexamethasone-based elixir or standard oral care', 'chemotherapy, oral care and a dexamethasone-based elixir (10\u2009mL 0.1\u2009mg/mL; swish for 2\u2009min and spit', 'steroid-containing mouthwash', 'dexamethasone-based elixir mouthwash']","['quality of life', 'incidence of stomatitis', 'safety and efficacy', 'severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678430', 'cui_str': 'Elixir (basic dose form)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C1699290', 'cui_str': 'Swish - dosing instruction imperative'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0566528', 'cui_str': 'Does spit (finding)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.109158,The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups.,"[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Kuba', 'Affiliation': 'Surgery, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan skuba@nagasaki-u.ac.jp.'}, {'ForeName': 'Kosho', 'Initials': 'K', 'LastName': 'Yamanouchi', 'Affiliation': 'Surgery, National Hospital Organisation Nagasaki Medical Center, Omura, Nagasaki, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Surgical Oncology, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Surgery, National Hospital Organisation Nagasaki Medical Center, Omura, Nagasaki, Japan.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Hatachi', 'Affiliation': 'Surgery, Japanese Red Cross Nagasaki Atomic Bomb Hospital, Nagasaki, Japan.'}, {'ForeName': 'Soutome', 'Initials': 'S', 'LastName': 'Sakiko', 'Affiliation': 'Oral Management Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kawashita', 'Affiliation': 'Oral Management Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Michi', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Surgery, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Sakimura', 'Affiliation': 'Surgery, Nagasaki Harbor Medical Center City Hospital, Nagasaki, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Inamasu', 'Affiliation': 'Hakujujikai Sasebo Chuo Hospital, Sasebo, Nagasaki, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Shibata', 'Affiliation': 'Surgery, Japanese Red Cross Nagasaki Atomic Bomb Hospital, Nagasaki, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Otsubo', 'Affiliation': 'Surgical Oncology, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yano', 'Affiliation': 'Surgical Oncology, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Nose', 'Affiliation': 'Pharmacy, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Miyamoto', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kanetaka', 'Affiliation': 'Surgery, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Surgery, Japanese Red Cross Nagasaki Atomic Bomb Hospital, Nagasaki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Umeda', 'Affiliation': 'Clinical Oral Oncology, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagayasu', 'Affiliation': 'Surgical Oncology, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Eguchi', 'Affiliation': 'Surgery, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-033446'] 696,32075842,High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol.,"INTRODUCTION Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room. Standard oxygen therapy (SOT) is used to prevent hypoxaemia. Data suggest that risk factors for hypoxaemia under deep sedation during GIE are obstructive sleep apnoea syndrome, a body mass index above 30 kg/m², high blood pressure, diabetes, heart disease, age over 60 years old, high American Society of Anesthesiologists physical status class and the association of upper and lower GIE. High-flow nasal oxygenation (HFNO) may potentially improve oxygenation during GIE under deep sedation. We hypothesised that HFNO could decrease the incidence of hypoxaemia in comparison with SOT. METHODS AND ANALYSIS The ODEPHI (High-flow nasal o xygenation versus standar d oxygenation for gastrointestinal e ndosco p y wit h sedation. The prospect i ve multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room. Three hundred and eighty patients will be randomised with a 1:1 ratio in two parallel groups.The primary outcome is the occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO 2 ) below or equal to 92% during the GIE procedure. Secondary outcomes include prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events. ETHICS AND DISSEMINATION This study has been approved by the ethics committee (CPP Sud Est Paris V, France), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals. As provided for by French law, patients participating in the study are informed that they have the possibility to ask the investigators, once the study is completed, to be informed of the overall results of the study. Thus, a summary of the results will be sent by post to the participants on request. TRIAL REGISTRATION NUMBER ClinicalTrials.gov Registry (NCT03829293).",2020,The prospect i ve multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room.,['Three hundred and eighty patients'],"['High-flow nasal oxygenation versus standard oxygenation', 'HFNO', 'High-flow nasal oxygenation (HFNO', 'Standard oxygen therapy (SOT']","['occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO 2 ', 'prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events', 'incidence of hypoxaemia']","[{'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C2711376', 'cui_str': 'ScO2 - Capillary oxygen saturation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",380.0,0.118983,The prospect i ve multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room.,"[{'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Eugene', 'Affiliation': 'Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Fromont', 'Affiliation': 'Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Auvet', 'Affiliation': ""Medical Intensive Care Unit, Hospital Dax Côte d'Argent, Dax, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Baert', 'Affiliation': 'Anaesthesiology, Oréliance Health Centre, Saran, France.'}, {'ForeName': 'Willy-Serge', 'Initials': 'WS', 'LastName': 'Mfam', 'Affiliation': ""Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional d'Orleans, Orleans, France.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Remerand', 'Affiliation': 'Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Boulain', 'Affiliation': ""Medical Intensive Care Unit, Centre Hospitalier Régional d'Orleans, Orleans, France.""}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Medical Intensive Care Unit, Centre Hospitalier Régional d'Orleans, Orleans, France mai-anh.nay@chr-orleans.fr.""}]",BMJ open,['10.1136/bmjopen-2019-034701'] 697,32079573,"Evaluation of the effect of multidisciplinary simulation-based team training on patients, staff and organisations: protocol for a stepped-wedge cluster-mixed methods study of a national, insurer-funded initiative for surgical teams in New Zealand public hospitals.","INTRODUCTION NetworkZ is a national, insurer-funded multidisciplinary simulation-based team-training programme for all New Zealand surgical teams. NetworkZ is delivered in situ, using full-body commercial simulators integrated with bespoke surgical models. Rolled out nationally over 4 years, the programme builds local capacity through instructor training and provision of simulation resources. We aim to improve surgical patient outcomes by improving teamwork through regular simulation-based multidisciplinary training in all New Zealand hospitals. METHODS AND ANALYSIS Our primary hypothesis is that surgical patient outcomes will improve following NetworkZ. Our secondary hypotheses are that teamwork processes will improve, and treatment injury claims will decline. In addition, we will explore factors that influence implementation and sustainability of NetworkZ and identify organisational changes following its introduction. The study uses a stepped-wedge cluster design. The intervention will roll out at yearly intervals to four cohorts of five District Health Boards. Allocation to cohort was purposive for year 1, and subsequently randomised. The primary outcome measure is Days Alive and Out of Hospital at 90 days using patient data from an existing national administrative database. Secondary outcomes measures will include analysis of postoperative complications and treatment injury claims, surveys of teamwork and safety culture, in-theatre observations and stakeholder interviews. ETHICS AND DISSEMINATION We believe this is the first surgical team training intervention to be implemented on a national scale, and a unique opportunity to evaluate a nation-wide team-training intervention for healthcare teams. By using a pre-existing large administrative data set, we have the potential to demonstrate a difference to surgical patient outcomes. This will be of interest to those working in the field of healthcare teamwork, quality improvement and patient safety. New Zealand Health and Disability Ethic Committee approval (#16/NTB/143). TRIAL REGISTRATION NUMBER Australian and New Zealand Clinical Trials Registry ID ACTRN12617000017325 and the Universal Trial Number is U1111-1189-3992.",2020,"We aim to improve surgical patient outcomes by improving teamwork through regular simulation-based multidisciplinary training in all New Zealand hospitals. ","['patients, staff and organisations: protocol for a stepped-wedge cluster-mixed methods study of a national, insurer-funded initiative for surgical teams in New Zealand public hospitals']","['multidisciplinary simulation-based team training', 'NetworkZ', 'regular simulation-based multidisciplinary training']","['Days Alive and Out of Hospital at 90 days using patient data from an existing national administrative database', 'analysis of postoperative complications and treatment injury claims, surveys of teamwork and safety culture, in-theatre observations and stakeholder interviews']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021675', 'cui_str': 'Insurers'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4045992', 'cui_str': 'Safety Culture'}, {'cui': 'C0475307', 'cui_str': 'Theatre (environment)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",,0.281729,"We aim to improve surgical patient outcomes by improving teamwork through regular simulation-based multidisciplinary training in all New Zealand hospitals. ","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Weller', 'Affiliation': 'Centre for Medical and Health Sciences Education, The University of Auckland, Auckland, New Zealand j.weller@auckland.ac.nz.'}, {'ForeName': 'Jennifer Anne', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Centre for Medical and Health Sciences Education, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beaver', 'Affiliation': 'Centre for Medical and Health Sciences Education, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cumin', 'Affiliation': 'Department of Anaesthesiology, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, Christchurch School of Medicine and Health Sciences, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Garden', 'Affiliation': 'Anaesthesia, Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Department of Anaesthesiology, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Webster', 'Affiliation': 'Centre for Medical and Health Sciences Education, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Merry', 'Affiliation': 'Department of Anaesthesiology, The University of Auckland, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2019-032997'] 698,32086350,Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial.,"INTRODUCTION Chronic musculoskeletal pain is a complex medical condition that can significantly impact quality of life. Patients with chronic pain demonstrate attentional biases towards pain-related information. The therapeutic benefits of modifying attentional biases by implicitly training attention away from pain-related information towards neutral information have been supported in a small number of published studies. Limited research however has explored the efficacy of modifying pain-related biases via the internet. This protocol describes a randomised, double-blind, internet-delivered attentional bias modification intervention, aimed to evaluate the efficacy of the intervention on reducing pain interference. Secondary outcomes are pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment. This study will also explore the effects of training intensity on these outcomes, along with participants' perceptions about the therapy. METHODS AND ANALYSIS The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit. Participants with chronic musculoskeletal pain will be randomised to one of four groups: (1) 10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group. In the attentional modification groups, the probe-classification version of the visual-probe task will be used to implicitly train attention away from threatening information towards neutral information. Following the intervention, participants will complete a short interview exploring their perceptions about the online training. In addition, a subgroup analysis for participants aged 16-24 and 25-60 will be undertaken. ETHICS AND DISSEMINATION This study has been approved by the University of Southampton Research Ethics Committee. Results will be published in peer-reviewed journals, academic conferences, and in lay reports for pain charities and patient support groups. TRIAL REGISTRATION NUMBER NCT02232100; Pre-results.",2020,"The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit.","['Participants with chronic musculoskeletal pain', 'Patients with chronic pain demonstrate attentional biases towards pain-related information', 'participants aged 16-24 and 25-60 will be undertaken', 'chronic musculoskeletal pain']","['online attentional bias modification training versus placebo training', '10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group', 'Internet-delivered attentional bias modification training (iABMT']","['pain interference', 'pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment']","[{'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.504369,"The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Liossi', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK cliossi@soton.ac.uk.'}, {'ForeName': 'Tsampikos', 'Initials': 'T', 'LastName': 'Georgallis', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Hamilton', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Applied Statistics Group, Engineering, Design and Mathematics, University of the West of England, Bristol, Bristol, UK.'}, {'ForeName': 'Daniel Eric', 'Initials': 'DE', 'LastName': 'Schoth', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030607'] 699,32086355,Adding evidence of the effects of treatments into relevant Wikipedia pages: a randomised trial.,"OBJECTIVES To investigate the effects of adding high-grade quantitative evidence of outcomes of treatments into relevant Wikipedia pages on further information-seeking behaviour by the use of routinely collected data. SETTING Wikipedia, Cochrane summary pages and the Cochrane Library. DESIGN Randomised trial. PARTICIPANTS Wikipedia pages which were highly relevant to up-to-date Cochrane Schizophrenia systematic reviews that contained a Summary of Findings table. INTERVENTIONS Eligible Wikipedia pages in the intervention group were seeded with tables of best evidence of the effects of care and hyperlinks to the source Cochrane review. Eligible Wikipedia pages in the control group were left unchanged. MAIN OUTCOME MEASURES Routinely collected data on access to the full text and summary web page (after 12 months). RESULTS We randomised 70 Wikipedia pages (100% follow-up). Six of the 35 Wikipedia pages in the intervention group had the tabular format deleted during the study but all pages continued to report the same data within the text. There was no evidence of effect on either of the coprimary outcomes: full-text access adjusted ratio of geometric means 1.30, 95% CI: 0.71 to 2.38; page views 1.14, 95% CI: 0.6 to 2.13. Results were similar for all other outcomes, with exception of Altmetric score for which there was some evidence of clear effect (1.36, 95% CI: 1.05 to 1.78). CONCLUSIONS The pursuit of fair balance within Wikipedia healthcare pages is impressive and its reach unsurpassed. For every person who sought and clicked the reference on the 'intervention' Wikipedia page to seek more information (the primary outcome), many more are likely to have been informed by the page alone. Enriching Wikipedia content is, potentially, a powerful way to improve health literacy and it is possible to test the effects of seeding pages with evidence. This trial should be replicated, expanded and developed. TRIAL REGISTRATION NUMBER IRCT2017070330407N2.",2020,"Results were similar for all other outcomes, with exception of Altmetric score for which there was some evidence of clear effect (1.36, 95% CI: 1.05 to 1.78). ","['Wikipedia pages which were highly relevant to up-to-date Cochrane Schizophrenia systematic reviews that contained a Summary of Findings table', 'Wikipedia, Cochrane summary pages and the Cochrane Library']",[],"['Altmetric score', 'Eligible Wikipedia pages']","[{'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1955832', 'cui_str': 'Systematic Review'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0023621', 'cui_str': 'Libraries'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.201159,"Results were similar for all other outcomes, with exception of Altmetric score for which there was some evidence of clear effect (1.36, 95% CI: 1.05 to 1.78). ","[{'ForeName': 'Clive E', 'Initials': 'CE', 'LastName': 'Adams', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK clive.adams@nottingham.ac.uk.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Aburrow', 'Affiliation': 'Health Sciences, Research, John Wiley Ltd, Chichester, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Critical Care, East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Briley', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ebun', 'Initials': 'E', 'LastName': 'Carew', 'Affiliation': 'General Medicine, Nottingham University Hospitals Healthcare NHS Trust, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Suravi', 'Initials': 'S', 'LastName': 'Chatterjee-Woolman', 'Affiliation': 'Orthopaedics, Sherwood Forest Hospitals NHS Foundation Trust, Sutton-in-Ashfield, UK.'}, {'ForeName': 'Ghalia', 'Initials': 'G', 'LastName': 'Feddah', 'Affiliation': 'Emergency Department, Gold Coast University Hospitals, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Friedel', 'Affiliation': 'Faculty Management and Business Science, University of Aalen, Aalen, Germany.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Gibbard', 'Affiliation': 'The Acute Stroke Unit - Huggett Suite, Royal Lancaster Infirmary, Lancaster, UK.'}, {'ForeName': 'Euan', 'Initials': 'E', 'LastName': 'Haynes', 'Affiliation': 'Haematology, Gateshead Health NHS Foundation Trust, Gateshead, Gateshead, UK.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Department of Radiology, University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayaram', 'Affiliation': 'Psychaitry, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Naylor', 'Affiliation': 'Emergency Department, Gold Coast University Hospitals, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Perry', 'Affiliation': 'Department of Anaesthesia, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Schmidt', 'Affiliation': 'Bristol Medical School, University of Bristol Faculty of Health Sciences, Bristol, Bristol, UK.'}, {'ForeName': 'Umer', 'Initials': 'U', 'LastName': 'Siddique', 'Affiliation': 'Community Recovery Psychiatry, North East London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ayla Serena', 'Initials': 'AS', 'LastName': 'Tabaksert', 'Affiliation': 'Liaison Psychiatry, Northumbria Healthcare NHS Foundation Trust, North Shields, Tyne and Wear, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Wikimedia UK, Wikimedia Foundation, London, UK.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Velani', 'Affiliation': 'Acute Medicine, Lewisham and Greenwich NHS Trust, London, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Accident and Emergency, Epsom and Saint Helier University Hospitals NHS Trust Epsom Hospital, Epsom, Surrey, UK.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Nottingham Ningbo GRADE Centre, Nottingham China Health Institute, The University of Nottingham Ningbo, Ningbo, China.'}]",BMJ open,['10.1136/bmjopen-2019-033655'] 700,30677620,Implementation of a structured communication tool improves family satisfaction and expectations in the intensive care unit.,"BACKGROUND Intensive care unit (ICU) physicians should provide relatives of critically ill patients with appropriate and clear information, regarding prognosis, treatment options and expectations. OBJECTIVES To assess whether a structured communication tool improves satisfaction with care and engenders realistic expectations among relatives of critically ill patients. STUDY DESIGN A controlled, pre-post intervention design was implemented in the General and Medical ICUs in the Hadassah-Hebrew University Medical Center, Jerusalem, Israel. METHODS Forty relatives of patients who received usual communication from the medical staff (control group) were interviewed. We then implemented a structured communication tool and another forty family members were interviewed (intervention group). The ICU physicians who participated in the family meeting were also interviewed. RESULTS Satisfaction in the intervention group was higher regarding ease of obtaining the information (90% vs 70%, p = .025) and the consistency of information provided (92.5% vs 77.5%, p = .057). There was better correlation between physicians' and relatives' expectations in the intervention group regarding hospital survival (Kappa 0.322 vs 0.054, p = .01). Physicians predicted more accurately patients' actual hospital survival. CONCLUSIONS A structured communication tool was associated with improved family satisfaction with communication and expectations regarding hospital survival. Further research is required to evaluate this promising intervention.",2019,"There was better correlation between physicians' and relatives' expectations in the intervention group regarding hospital survival (Kappa 0.322 vs 0.054, p = .01).","['General and Medical ICUs in the Hadassah-Hebrew University Medical Center, Jerusalem, Israel', 'ICU physicians who participated in the family meeting were also interviewed', 'relatives of critically ill patients', 'Forty relatives of patients who received usual communication from the medical staff (control group) were interviewed']",['structured communication tool'],"['hospital survival', 'higher regarding ease of obtaining the information', ""patients' actual hospital survival"", 'family satisfaction with communication and expectations regarding hospital survival']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0025106', 'cui_str': 'Medical Staff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",,0.0551302,"There was better correlation between physicians' and relatives' expectations in the intervention group regarding hospital survival (Kappa 0.322 vs 0.054, p = .01).","[{'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Sviri', 'Affiliation': 'Medical Intensive Care Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. Electronic address: sigals@hadassah.org.il.'}, {'ForeName': 'Dekel', 'Initials': 'D', 'LastName': 'Geva', 'Affiliation': 'Medical Intensive Care Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Peter Vernon', 'Initials': 'PV', 'LastName': 'vanHeerden', 'Affiliation': 'General Intensive Care Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Romain', 'Affiliation': 'Medical Intensive Care Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Rawhi', 'Affiliation': 'General Intensive Care Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Abutbul', 'Affiliation': 'Medical Intensive Care Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Orenbuch-Harroch', 'Affiliation': 'Medical Intensive Care Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Netta', 'Initials': 'N', 'LastName': 'Bentur', 'Affiliation': 'Minerva Center for the Interdisciplinary Study of End of Life, Tel-Aviv University, Israel.'}]",Journal of critical care,['10.1016/j.jcrc.2019.01.011'] 701,32156479,The effect of renin-angiotensin-aldosterone system blockers on the progression of chronic kidney disease in hypertensive elderly patients without proteinuria: PROERCAN study. Rationale and design.,"INTRODUCTION Blood pressure (BP) control is fundamental to the care of patients with chronic kidney disease (CKD), and is relevant at all stages of CKD. Renin-angiotensin-aldosterone system (RAAS) blockers have shown to be effective, not only in BP control but also in reducing proteinuria and slowing CKD progression. However, there is a lack of evidence for recommending RAAS blockers in elderly patients with CKD without proteinuria. The primary outcome of the present study is to evaluate the impact of RAAS blockers on CKD progression in elderly patients without proteinuria. MATERIALS AND METHODS The PROERCAN trial (trial registration, NCT03195023) is a multicentre open-label, randomized controlled clinical trial with 110 participants over 65 years-old with hypertension and CKD stages 3-4 without proteinuria. Patients will be randomized in a 1:1 ratio to either receive RAAS blockers or other antihypertensive drugs, and will be followed up for three years. Primary outcome is the estimated glomerular filtration rate (eGFR) decline at 3 years. Secondary outcomes include BP control, renal and cardiovascular events, and mortality. RESULTS AND CONCLUSIONS The design of this trial is presented here. The results will show if antihypertensive treatment with RAAS blockers has an impact on CKD progression in elderly patients without proteinuria. Any differences in BP control, cardiovascular events, and mortality with each antihypertensive treatment will be also clarified.",2020,The results will show if antihypertensive treatment with RAAS blockers has an impact on CKD progression in elderly patients without proteinuria.,"['elderly patients without proteinuria', 'hypertensive elderly patients without proteinuria', 'elderly patients with CKD without proteinuria', '110 participants over 65 years-old with hypertension and CKD stages 3-4 without proteinuria', 'patients with chronic kidney disease (CKD']","['Blood pressure (BP) control', 'RAAS blockers', 'RAAS blockers or other antihypertensive drugs', 'Renin-angiotensin-aldosterone system (RAAS) blockers', 'renin-angiotensin-aldosterone system blockers']","['BP control, cardiovascular events, and mortality', 'chronic kidney disease', 'estimated glomerular filtration rate (eGFR) decline', 'BP control, renal and cardiovascular events, and mortality', 'CKD progression']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3539170', 'cui_str': 'OTHER ANTIHYPERTENSIVES in ATC'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3811844'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",110.0,0.0836877,The results will show if antihypertensive treatment with RAAS blockers has an impact on CKD progression in elderly patients without proteinuria.,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'García-Prieto', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain. Electronic address: anamgarciaprieto@gmail.com.'}, {'ForeName': 'Ú', 'Initials': 'Ú', 'LastName': 'Verdalles', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'de José', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Verde', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Aragoncillo', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Linares', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Barbieri', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goicoechea', 'Affiliation': 'Servicio Nefrología Hospital General Universitario Gregorio Marañón, Calle Doctor Esquerdo 46, 28007 Madrid, Spain; Spanish Research Network (REDINREN), Madrid, Spain.'}]",Hipertension y riesgo vascular,['10.1016/j.hipert.2020.02.005'] 702,32174573,Evaluation of Scheimpflug imaging system as an added tool in improving the accuracy of reference marking (as compared to the slit lamp marking system) for toric intraocular lens implantation.,"Purpose To assess the role of Scheimpflug imaging in improving the accuracy of reference marking for toric IOL implantation. Methods In this prospective, randomized, clinical trial all patients with cataract and pre-existing significant regular corneal astigmatism, who required implantation of a toric IOL were included in the study, and patients with any ocular pathology or abnormality were excluded. Patients were divided into two groups: For one group of patients, Group I (GI), reference marking was finalized using slit lamp only, and for the second group, Group II (GII), after slit lamp marking, the reference marks were checked using Goniometer of Scheimpflug imaging. The primary outcome was to determine the axis of toric intraocular lens (IOL) postoperatively (within 1 hour) and compare it with the desired axis of placement. Results We found a statistically significant difference in the two groups (P < 0.001) suggesting Group II (4 step technique) is better than Group I (3 step technique). Conclusion Scheimpflug imaging, an extra step preoperatively, is an effective measure to reduce errors in reference marking and thereby improving the refractive outcome of toric intraocular lens.",2020,"We found a statistically significant difference in the two groups (P < 0.001) suggesting Group II (4 step technique) is better than Group I (3 step technique). ","['patients with cataract and pre-existing significant regular corneal astigmatism, who required implantation of a toric IOL were included in the study, and patients with any ocular pathology or abnormality were excluded']",[],['axis of toric intraocular lens (IOL) postoperatively (within 1 hour) and compare it with the desired axis of placement'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]",[],"[{'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.030955,"We found a statistically significant difference in the two groups (P < 0.001) suggesting Group II (4 step technique) is better than Group I (3 step technique). ","[{'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Amber Eye Care and Micro Surgery Centre, Thane, Maharashtra, India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'Amber Eye Care and Micro Surgery Centre, Thane, Maharashtra, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1253_19'] 703,32174580,Surgically induced astigmatism and refractive outcomes following phacotrabeculectomy.,"Purpose To objectively evaluate surgically induced astigmatism (SIA) after phacotrabeculectomy using keratometry and topography and to compare the magnitude of SIA and the refractive outcomes of single-site and twin-site phacotrabeculectomies. Methods Forty prospective subjects were enrolled in the study and were randomized into single-site and twin-site cohorts. SIA was objectively assessed using keratometry and Orbscan before and at three months after surgery. For both cohorts, the changes in SIA were assessed using power vector analysis compared at the third month after surgery. Results Each cohort consisted of 20 eyes. The preoperative parameters and postoperative IOP were comparable and similar, respectively, in both the cohorts (P = 0.1). Majority of the patients in both the cohorts had preoperative against-the-rule (ATR) astigmatism. The median change in SIA at the three-month postoperative visit was similar in both the cohorts, with a small increase in ATR astigmatism. Although the SIA change measured by keratometry in the J0 component was similar in both the groups (P = 0.54), that of J45 was significantly different (P = 0.01). However, the median change in SIA was similar in both the groups for both the J0 (P = 0.52) and J45 components (P = 0.94) when measured by Orbscan. The SIA in both the groups measured with keratometry (P = 0.62) and topography (P = 0.52) were clinically and statistically similar. In both the groups, the refraction was similar at 1 month and 3 months. Conclusion The SIA as measured with keratometry and topography was similar in the single-site and twin-site phacotrabeculectomy cohorts at the end of 3-months. The postoperative refraction was stabilized in 1-month in both the groups.",2020,The SIA in both the groups measured with keratometry (P = 0.62) and topography (P = 0.52) were clinically and statistically similar.,['Methods\n\n\nForty prospective subjects were enrolled in the study and were randomized into single-site and twin-site cohorts'],['phacotrabeculectomy'],"['SIA change measured by keratometry in the J0 component', 'preoperative parameters and postoperative IOP', 'median change in SIA', 'postoperative refraction', 'ATR astigmatism']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0430885', 'cui_str': 'Keratometry (procedure)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C1720245', 'cui_str': 'Against-the-rule astigmatism'}]",40.0,0.0466958,The SIA in both the groups measured with keratometry (P = 0.62) and topography (P = 0.52) were clinically and statistically similar.,"[{'ForeName': 'Sirisha', 'Initials': 'S', 'LastName': 'Senthil', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'GMRV Campus, L V Prasad Eye Institute, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Kiranmaye', 'Initials': 'K', 'LastName': 'Turaga', 'Affiliation': 'GMRV Campus, L V Prasad Eye Institute, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Veerendranath', 'Initials': 'V', 'LastName': 'Pesala', 'Affiliation': 'Brien Holden Institute of Optometry and Vision Sciences, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Praveen K', 'Initials': 'PK', 'LastName': 'Bandela', 'Affiliation': 'Brien Holden Institute of Optometry and Vision Sciences, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Jonnadula', 'Initials': 'J', 'LastName': 'Ganesh', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Garudadri', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Bharadwaj', 'Affiliation': 'VST Glaucoma Center, L V Prasad Eye Institute, Banjara Hills, Hyderabad, Telangana, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_588_19'] 704,32174581,Intraoperative injection versus sponge-applied mitomycin C during trabeculectomy: One-year study.,"Purpose To determine the safety and efficacy of mitomycin C (MMC) injection versus sponge during trabeculectomy. Methods It is a prospective analysis of patients who underwent trabeculectomy with MMC and followed up for 1 year, divided into two groups, namely, group 1- injection (n = 21), group 2-> sponge (n = 21). The same concentration of MMC was used for both groups. Inclusion criteria were trabeculectomies with MMC for intraocular pressure (IOP) control in eyes with glaucoma (primary + secondary) with a follow-up of 1 year. Results Mean preoperative IOP in group 1 was 29.00 ± 11.92 mmHg and group 2 was 25.87 ± 11.09 mmHg, which reduced to 12.19 ± 4.03 and 15.56 ± 10.72 mmHg at final visit with P value of 0.0002 and 0.001, respectively. Mean preoperative number of antiglaucoma medications was 2.4 ± 0.87 in group 1 and 2.3 ± 0.96 in group 2, which reduced to 0.38 ± 0.5 and 0.91 ± 0.85 with P value of 0.001 and 0.0003, respectively. The complete success rate was 52.4% in the injection group and 26.1% in the sponge group at end of 1 year. Overall, success rate (complete + qualified) was 90.5% and 87% in group 1 and group 2 at final visit. All major complications were encountered in sponge group. 1 (11.1%) patient developed choroidal detachment and one had malignant glaucoma which got resolved by medical management. 33.3% cases had encapsulated bleb which received bleb needling. 44.4% cases underwent Argon laser suture lysis postoperatively. Conclusion The MMC injection may be as safe and as effective as conventional sponge application with comparable estimated complete treatment success.",2020,"Overall, success rate (complete + qualified) was 90.5% and 87% in group 1 and group 2 at final visit.","['Inclusion criteria were trabeculectomies with MMC for intraocular pressure (IOP) control in eyes with glaucoma (primary + secondary) with a follow-up of 1 year', 'patients who underwent']","['mitomycin C (MMC) injection', 'Argon laser suture lysis postoperatively', 'trabeculectomy with MMC', 'Intraoperative injection versus sponge-applied mitomycin C during trabeculectomy', 'bleb needling']","['choroidal detachment and one had malignant glaucoma', 'Mean preoperative IOP', 'success rate', 'Mean preoperative number of antiglaucoma medications', 'complete success rate', 'safety and efficacy']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0392247', 'cui_str': 'Argon Ion Lasers'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C3714607', 'cui_str': 'Filtering bleb'}]","[{'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C0271152', 'cui_str': 'Malignant glaucoma (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0609664,"Overall, success rate (complete + qualified) was 90.5% and 87% in group 1 and group 2 at final visit.","[{'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Kanduri', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': 'Ramakrishnan', 'Initials': 'R', 'LastName': 'Rengappa', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': 'Mohideen Abdul', 'Initials': 'MA', 'LastName': 'Kadar', 'Affiliation': 'Department of Glaucoma, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Tirunelveli, Tamil Nadu, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_963_19'] 705,32159070,Eating Pattern Response to a Low-Fat Diet Intervention and Cardiovascular Outcomes in Normotensive Women: The Women's Health Initiative.,"Background Women without cardiovascular disease (CVD) or hypertension at baseline assigned to intervention in the Women's Health Initiative Dietary Modification (DM) trial experienced 30% lower risk of coronary heart disease (CHD), whereas results in women with hypertension or prior CVD could have been confounded by postrandomization use of statins. Objectives Intervention participants reported various self-selected changes to achieve the 20% total fat goals. Reviewed are intervention compared with comparison group HRs for CHD, stroke, and total CVD in relation to specific dietary changes in normotensive participants. Methods Dietary change was assessed by comparing baseline with year 1 FFQ data in women ( n  = 10,371) without hypertension or CVD at baseline with intake of total fat above the median to minimize biases due to use of the FFQ in trial eligibility screening. Results Intervention participants self-reported compensating reduced energy intake from total fat by increasing carbohydrate and protein. Specifically they increased plant protein, with those in the upper quartile (increased total protein by ≥3.3% of energy) having a CHD HR of 0.39 (95% CI: 0.22, 0.71), compared with 0.92 (95% CI: 0.57, 1.48) for those in the lower quartile of change (decreased total protein ≥0.6% of energy), with P -trend of 0.04. CHD HR did not vary significantly with change in percentage energy from carbohydrate, and stroke HR did not vary significantly with any macronutrient changes. Scores reflecting adherence to recommended dietary patterns including the Dietary Approaches to Stop Hypertension Trial and the Healthy Eating Index showed favorable changes in the intervention group. Conclusions Intervention group total fat reduction replaced with increased carbohydrate and some protein, especially plant-based protein, was related to lower CHD risk in normotensive women without CVD who reported high baseline total fat intake. This trial was registered at clinicaltrials.gov as NCT00000611. Link to the WHI trial protocol: https://www.whi.org/about/SitePages/Dietary%20Trial.aspx.",2020,"Scores reflecting adherence to recommended dietary patterns including the Dietary Approaches to Stop Hypertension Trial and the Healthy Eating Index showed favorable changes in the intervention group. ","['women with hypertension or prior CVD', ""\n\n\nWomen without cardiovascular disease (CVD) or hypertension at baseline assigned to intervention in the Women's Health Initiative Dietary Modification (DM) trial experienced 30% lower risk of coronary heart disease (CHD"", 'Normotensive Women', 'normotensive participants']",['Low-Fat Diet Intervention'],"['CHD HR', 'percentage energy from carbohydrate, and stroke HR', 'plant protein', 'Healthy Eating Index', 'various self-selected changes to achieve the 20% total fat goals']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0086153', 'cui_str': 'Dietary Modification'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}]","[{'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032089', 'cui_str': 'Plant Proteins'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",10371.0,0.0609248,"Scores reflecting adherence to recommended dietary patterns including the Dietary Approaches to Stop Hypertension Trial and the Healthy Eating Index showed favorable changes in the intervention group. ","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Barbara V', 'Initials': 'BV', 'LastName': 'Howard', 'Affiliation': 'Center for Study of Sex Differences in Health, Aging, & Disease, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Allison', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carmen R', 'Initials': 'CR', 'LastName': 'Isasi', 'Affiliation': 'Department of Epidemiology & Population Health, and Department of Pediatrics, Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mossavar-Rahmani', 'Affiliation': 'Department of Epidemiology & Population Health, Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona Mel & Enid Zuckerman College of Public Health, Tucson, AZ, USA.'}, {'ForeName': 'Mara Z', 'Initials': 'MZ', 'LastName': 'Vitolin', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': 'Department of Epidemiology, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Current developments in nutrition,['10.1093/cdn/nzaa021'] 706,32162204,TrimetaziDine as a Performance-enhancING drug in heart failure with preserved ejection fraction (DoPING-HFpEF): rationale and design of a placebo-controlled cross-over intervention study.,"BACKGROUND Currently, no specific treatment exists for heart failure with preserved ejection fraction (HFpEF). Left ventricular (LV) relaxation during diastole is a highly energy-demanding process, while energy homeostasis is known to be compromised in HFpEF. We hypothesise that trimetazidine - a fatty acid β‑oxidation inhibitor - improves LV diastolic function in HFpEF, by altering myocardial substrate use and improving the myocardial energy status. OBJECTIVES To assess whether trimetazidine improves LV diastolic function by improving myocardial energy metabolism in HFpEF. METHODS The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF. The main inclusion criteria are: New York Heart Association functional class II to IV, LV ejection fraction ≥50%, and evidence of LV diastolic dysfunction. Patients are treated with one 20-mg trimetazidine tablet or placebo thrice daily (twice daily in the case of moderate renal dysfunction) for two periods of 3 months separated by a 2-week washout period. The primary endpoint is the change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation. Our key secondary endpoint is the myocardial phosphocreatine (PCr)/ATP ratio measured by phosphorus-31 magnetic resonance spectroscopy and its relation to the primary endpoint. Exploratory endpoints are 6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life. CONCLUSION The DoPING-HFpEF is a phase-II trial that evaluates the effect of trimetazidine, a metabolic modulator, on diastolic function and myocardial energy status in HFpEF. [EU Clinical Trial Register: 2018-002170-52; NTR registration: NL7830].",2020,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","['heart failure with preserved ejection fraction (DoPING-HFpEF', '25\xa0patients with stable HFpEF']","['trimetazidine -\xa0a\xa0fatty acid β‑oxidation inhibitor ', 'placebo', 'TrimetaziDine', 'trimetazidine and placebo', 'trimetazidine', 'trimetazidine tablet or placebo']","['myocardial phosphocreatine (PCr)/ATP ratio', '6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life', 'LV diastolic function', 'change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1533071', 'cui_str': 'N-terminal pro-brain natriuretic peptide measurement'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart (procedure)'}]",,0.228946,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'van de Bovenkamp', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Bakermans', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W E M', 'Initials': 'WEM', 'LastName': 'Kok', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Handoko', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. ml.handoko@amsterdamumc.nl.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01407-z'] 707,32134956,Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy.,"HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW). These populations use alcohol more heavily than the general population, and alcohol use disorders (AUDs) are more prevalent among them. Naltrexone (NTX) has documented efficacy and safety as a medication-assisted therapy for AUD. Its use has not been well-examined in persons with HIV (PWH) newly initiating antiretroviral therapy (ART) where the possibility of hepatotoxicity may be increased when initating multiple new medications. This study assessed the safety of oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART) in a double-blind randomized placebo-controlled trial of NTX in MSM/TW in Lima, Peru among MSM and TW with AUD (AUDIT score ≥ 8). We analyzed adverse event data from ART-naïve participants (N = 155) who were randomized (2:1) to initiate ART plus NTX (N = 103) or ART plus placebo (N = 52). Participants were monitored for 24 weeks while taking ART plus NTX/placebo, followed by 24 weeks receiving ART alone. Over 48 weeks, 135 grade 2 or 3 adverse events were reported, resulting in 1.3 clinical adverse events per participant equally represented in both treatment and placebo arms. Two serious adverse events occurred among two participants receiving NTX; neither was attributed to the study medication. No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points. These results suggest NTX is safe in MSM/TW PWH with AUD newly initiating ART, as no excess of clinical adverse events or transaminase elevation was associated with NTX use.",2020,No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points.,"['HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy', 'persons with HIV (PWH) newly initiating antiretroviral therapy (ART', 'HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW', 'ART-naïve participants (N = 155) who were randomized (2:1) to']","['oral naltrexone', 'NTX', 'placebo', 'ART plus placebo', 'initiate ART plus NTX', 'Naltrexone (NTX', 'ART plus NTX/placebo', 'oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART']","['proportion of subjects reporting any adverse events', 'adverse events']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",155.0,0.257235,No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Grieco', 'Affiliation': 'University of Illinois at Chicago, School of Public Health, Chicago, IL, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'White', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Ding', 'Affiliation': 'University of Washington, School of Medicine, Seattle, WA, United States of America.'}, {'ForeName': 'Rachel Bender', 'Initials': 'RB', 'LastName': 'Ignacio', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Pinto-Santini', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Duerr', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}]",PloS one,['10.1371/journal.pone.0228433'] 708,32047010,Does a web-based decision aid improve informed choice for fertility preservation in women with breast cancer (DECISIF)? Study protocol for a randomised controlled trial.,"INTRODUCTION Chemotherapy may cause infertility in young survivors of breast cancer. Various fertility preservation techniques increase the likelihood of survivors becoming genetic mothers. Disclosure of cancer diagnosis may impact decision making about fertility preservation. This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation. METHODS AND ANALYSIS This study will be conducted in three phases using mixed methods. In phase I, the aim is to develop a web-based patient decision aid (PDA) in French with a steering committee and using a focus group of five women already treated for breast cancer. In phase II, the face validity of the decision aid will be assessed using questionnaires. In phase III, the PDA will be assessed by a two-arm randomised controlled trial. This will involve a quantitative evaluation of the PDA in clinical practice comparing the quality of the decision-making process between usual care and the PDA. The primary outcome will be informed choice and its components. The secondary outcomes will be decisional conflict and anxiety. Data will be collected during and after an oncofertility consultation. Phase III is underway. Since September 2018, 52 participants have been enrolled in the study and have completed the survey. We expect to have results by February 2020 for a total of 186 patients. ETHICS AND DISSEMINATION This study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings. TRIAL REGISTRATION NUMBER The ClinicalTrials.gov registry .(NCT03591848).",2020,"This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation. ","['February 2020 for a total of 186 patients', 'women with breast cancer (DECISIF', 'young survivors of breast cancer', 'Since September 2018, 52 participants have been enrolled in the study and have completed the survey', 'survivors becoming genetic mothers']",['Chemotherapy'],['decisional conflict and anxiety'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",186.0,0.159322,"This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation. ","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Benoit', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Université, Caen, France alexandra.benoit@aphp.fr.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grynberg', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine-Béclère, Clamart, France.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Universite, Caen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sermondade', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Bondy, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Grandazzi', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Universite, Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Moutel', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Universite, Caen, France.'}]",BMJ open,['10.1136/bmjopen-2019-031739'] 709,32047011,Improving depression outcomes among Australian primary care patients: protocol for a cluster randomised controlled trial.,"INTRODUCTION Depression is a common and debilitating condition. In Australia, general practitioners (GPs) are the key providers of depression care. However, available evidence suggests that case finding for depression in primary care is poor. This study will examine whether a systematic approach to screening for depression and assessing patient preferences for depression care improves depression outcomes among primary care patients. METHODS AND ANALYSIS A cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12). Patients who are aged 18 and older, presenting for general practice care, will be eligible to participate. Eighty-three participants will be recruited at each clinic. Participants will be asked to complete a baseline survey administered on a touch screen computer at their GP clinic, and then a follow-up survey at 3, 6 and 12 months. Those attending usual care practices will receive standard care. GPs at intervention practices will complete an online Clinical e-Audit, and will be provided with provider and patient-directed resources for depression care. Patients recruited at intervention practices who score 10 or above on the Patient Health Questionnaire-9 will have feedback regarding their depression screening results and preferences for care provided to their GP. The primary analysis will compare the number of cases of depression between the intervention and control groups. ETHICS AND DISSEMINATION The study has been approved by the University of Newcastle Human Research Ethics Committee, and registered with Human Research Ethics Committees of the University of Wollongong, Monash University and University of New South Wales. Results will be disseminated through peer-reviewed journal publications and conference presentations. TRIAL REGISTRATION NUMBER ACTRN12618001139268; Pre-results.",2020,A cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12).,"['Patients recruited at intervention practices who score 10 or above on the Patient Health Questionnaire-9 will have feedback regarding their depression screening results and preferences for care provided to their GP', 'Eighty-three participants will be recruited at each clinic', 'Australian primary care patients', 'Patients who are aged 18 and older, presenting for general practice care, will be eligible to participate', 'primary care patients']",['usual care group'],"['number of cases of depression', 'depression outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0740218', 'cui_str': 'Depression screening (procedure)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",83.0,0.122334,A cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12).,"[{'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia Mariko.Carey@newcastle.edu.au.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Sanson-Fisher', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mazza', 'Affiliation': 'School of Primary and Allied Health Care, Department of General Practice, Monash University, Notting Hill, Victoria, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Meadows', 'Affiliation': 'Southern Synergy, Monash Health Adult Psychiatry Research, Training and Evaluation Centre, Dandenong, Victoria, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Piterman', 'Affiliation': 'School of Primary and Allied Health Care, Department of General Practice, Monash University, Notting Hill, Victoria, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Waller', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Deeming', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Searles', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Henskens', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032057'] 710,32047013,"Proximal Femoral Nail Unlocked versus Locked (ProFNUL): a protocol for a multicentre, parallel-armed randomised controlled trial for the effect of femoral nail mode of lag screw locking and screw configuration in the treatment of intertrochanteric femur fractures.","INTRODUCTION Intertrochanteric fractures are common fragility injuries in the elderly. Surgical fixation using intramedullary devices are one of the widely used management options. To date, evidence demonstrating the effects of lag screw configuration and the mode of lag screw locking in these devices is lacking. The purpose of this study is to investigate whether the lag screw configuration (single vs integrated dual interlocking screw) and the mode of lag screw locking (static vs dynamic) of a femoral nail device result in differences in clinical and functional outcomes. METHODS AND ANALYSIS A multicentre, pragmatic, single-blinded randomised controlled trial (RCT) with a three-arm parallel group design is proposed. Nine-hundred patients with intertrochanteric fractures (A1 and A2 AO/OTA) will be randomised to fracture treatment using a Gamma3 nail (Stryker; proximally dynamic) or a Trigen Intertan nail (Smith & Nephew) in a dynamic or static lag screw configuration. The primary outcome measure consists of radiological evidence of construct failure within 6 months following surgery, with failure being defined as breakage of the femoral nail or distal locking screw, a change in tip-apex distance of more than 10 mm or lag screw cut-out through the femoral head. Secondary outcomes include surgical data (operation time, fluoroscopy time), complications (surgical site infection, reoperation, patient death), return to mobility and home circumstances, functional independence, function and pain. Patients who are able to walk independently with or without a mobility aid and are able to answer simple questions and follow instructions will be asked to participate in three dimensional gait analysis at 6 weeks and 6 months to assess hip biomechanics from this cohort. Additional secondary measures of gait speed, hip range of motion, joint contact and muscle forces and gross activity monitoring patterns will be obtained in this subgroup. ETHICS AND DISSEMINATION The Central Adelaide Local Health Network Human Research Ethics Committee has approved the protocol for this RCT (HREC/17/RAH/433). The results will be disseminated via peer-reviewed publications and presentations at relevant conferences. TRIAL REGISTRATION NUMBER ACTRN12618001431213.",2020,Patients who are able to walk independently with or without a mobility aid and are able to answer simple questions and follow instructions will be asked to participate in three dimensional gait analysis at 6 weeks and 6 months to assess hip biomechanics from this cohort.,"['Nine-hundred patients with intertrochanteric fractures (A1 and A2 AO/OTA', 'intertrochanteric femur fractures']","['femoral nail mode of lag screw locking and screw configuration', 'lag screw configuration (single vs integrated dual interlocking screw', 'Gamma3 nail (Stryker; proximally dynamic) or a Trigen Intertan nail (Smith & Nephew', 'Proximal Femoral Nail Unlocked versus Locked (ProFNUL', 'lag screw locking (static vs dynamic) of a femoral nail device', 'Surgical fixation using intramedullary devices']","['radiological evidence of construct failure within 6\u2009months following surgery, with failure being defined as breakage of the femoral nail or distal locking screw, a change in tip-apex distance of more than 10\u2009mm or lag screw cut-out through the femoral head', 'surgical data (operation time, fluoroscopy time), complications (surgical site infection, reoperation, patient death), return to mobility and home circumstances, functional independence, function and pain', 'gait speed, hip range of motion, joint contact and muscle forces and gross activity monitoring patterns']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0337579', 'cui_str': 'Nephew (person)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C2584790', 'cui_str': 'Nail device'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0441273', 'cui_str': 'Locking screw (physical object)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0576002', 'cui_str': 'Joint movement: hip'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",900.0,0.178621,Patients who are able to walk independently with or without a mobility aid and are able to answer simple questions and follow instructions will be asked to participate in three dimensional gait analysis at 6 weeks and 6 months to assess hip biomechanics from this cohort.,"[{'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Sivakumar', 'Affiliation': 'Centre for Orthopaedic & Trauma Research (COTR), Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia arjun.sivakumar@adelaide.edu.au.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Thewlis', 'Affiliation': 'Centre for Orthopaedic & Trauma Research (COTR), Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ladurner', 'Affiliation': 'Department of Orthopaedics & Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'Adelaide Health Technology Assessment, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rickman', 'Affiliation': 'Department of Orthopaedics & Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032640'] 711,32086358,Tackling frailty at primary care: evaluation of the effectiveness of a multicomponent intervention through a randomised controlled trial: study protocol.,"INTRODUCTION This project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty. The final evaluation will be made at 12 months' follow-up. METHODS AND ANALYSIS Pragmatic multicentre cluster randomised controlled clinical trial, single blind with two arms: multifactorial intervention in PHC versus usual follow-up. The randomisation unit is the patient list and the analysis unit is the patient. In addition, a cost-effectiveness study and a qualitative study will be carried out, the latter based on semistructured interviews and focus groups. Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited. A baseline evaluation will be carried out prior to the intervention, with follow-up at 6 and 12 months. The main study variables considered will be functional capacity and incidence of adverse events; the secondary variables considered will be the patients' sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life. Data will be analysed according to the intention-to-treat principle using a 5% significance level. ETHICS AND DISSEMINATION The study will at all times be conducted in strict accordance with the provisions of the Declaration of Helsinki and with the national legislation regulating patients' autonomy. All patients recruited will be asked to provide written informed consent before taking part in the clinical trial. On completion of the study, the principal investigator expects to publish the results of this research in a peer-reviewed open access scientific journal. TRIAL REGISTRATION NUMBER ISRCTN17143761.",2020,"This project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty.","['primary healthcare (PHC', 'persons with frailty', 'Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited']","['multifactorial intervention in PHC versus usual follow-up', 'multifactorial intervention', 'multicomponent intervention']","['functional capacity and incidence of adverse events', 'sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4273559', 'cui_str': 'Functionally independent'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.071683,"This project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Rivas-Ruiz', 'Affiliation': 'Unidad de Investigación, Agencia Sanitaria Costa del Sol, Marbella, Málaga, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Machón', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain monica.machonsobrado@osakidetza.eus.'}, {'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Mateo-Abad', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Contreras-Fernández', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Güell', 'Affiliation': 'Instituto de Investigación Sanitaria Biodonostia, Grupo de Atención Primaria, San Sebastián, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Baro-Rodríguez', 'Affiliation': 'Área del Medicamento, Distrito Sanitario de Atencion Primaria Costa del Sol, Mijas, Spain.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Vrotsou', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Quirós-López', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Vergara', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034591'] 712,32086359,"Improving reproductive function in women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT): study protocol for a two-centre, three-armed randomised controlled trial.","INTRODUCTION Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and the leading cause of anovulatory infertility. Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI). A healthy lifestyle is recommended to improve overall health and fertility in PCOS but there is limited evidence on the isolated effects of exercise, especially for reproductive outcomes. Previous findings indicate superior metabolic health benefits after vigorous compared with moderate-intensity exercise. Our primary aim is to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS. METHODS AND ANALYSIS The study is a two-centre, randomised, controlled trial with three parallel groups. Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria will be randomly allocated (1:1:1) to high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27 kg/m 2 and study centre. Measurements for study end points will be undertaken at baseline, after a 16 week exercise intervention and at 12 months following baseline assessments. The primary outcome measure is menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings during a 12-month period. Secondary outcome measurements include markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise. ETHICS AND DISSEMINATION The Regional Committee Medical Research Ethics, Norway, and The Australian Catholic University Human Research Ethics Committee, Australia, have approved the trial protocol. This trial will provide new insight regarding the impact of exercise on fertility in PCOS. We expect this trial to contribute to new therapeutic exercise strategies as part of clinical care for women with PCOS. TRIAL REGISTRATION NUMBER Clinical trial gov NCT02419482.",2020,"Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI).","['Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria', 'women with PCOS', 'women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT']","['high-intensity interval training (HIT', 'high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27\u2009kg/m 2 and study centre']","['overall health and fertility in PCOS', 'menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings', 'markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0960740', 'cui_str': 'ImProv'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.352155,"Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI).","[{'ForeName': 'Ida Almenning', 'Initials': 'IA', 'LastName': 'Kiel', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Lionett', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Evelyn Bridget', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Programme, Mary Mackillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'Research Institute for Sport and Exercise Science (RISES), Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Maria Aurora Hernandez', 'Initials': 'MAH', 'LastName': 'Røset', 'Affiliation': 'Department of Obstetrics and Gynaecology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Unit of Applied Clinical Research, Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': 'Department of Obstetrics and Gynaecology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Moholdt', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway trine.moholdt@ntnu.no.'}]",BMJ open,['10.1136/bmjopen-2019-034733'] 713,31928864,An Exploration of the Application of Noninvasive Cerebellar Stimulation in the Neuro-rehabilitation of Dysphagia after Stroke (EXCITES) Protocol.,"BACKGROUND Poststroke dysphagia is common, associated with a poor outcome and has no definitive treatments. Repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum is a noninvasive technique requiring minimal physical or cognitive input from the patient, and has been shown to induce positive swallow-related brain changes in physiological studies as measured by increased cortical excitability. AIM To explore in patients with acute/sub-acute poststroke dysphagia: (1) the feasibility and immediate effect; and (2) the optimal dose for long-term benefit, of cerebellar rTMS in patients with dysphagia in acute/sub-acute stroke. METHODS Two double-blind sham-controlled randomized phase II trials. Participants will be recruited from stroke units in Nottingham and Greater Manchester. Dysphagia will be confirmed via baseline videofluoroscopy (VFS). Participants will be blinded to treatment and receive cerebellar rTMS or sham stimulation: (1) single treatment of (10Hz, 250 pulse) in 24 participants; (2) daily for 3 days, twice-daily for 5 days, or twice-daily sham treatment for 5 days, in 48 participants. RESULTS The severity of dysphagia will be assessed with VFS, using the penetration aspiration scale (PAS) at: (1) 1-hour, (2) 2-weeks, post-treatment. Additional comparative measures will be taken from: (1) pharyngeal motor evoked potential (MEP) amplitudes, (2) the functional oral intake score and dysphagia severity rating scale. CONCLUSIONS If these studies demonstrate feasibility and identify optimal dosing, further trials to assess the safety and efficacy of cerebellar rTMS as a treatment for poststroke dysphagia will be warranted.",2020,"Repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum is a noninvasive technique requiring minimal physical or cognitive input from the patient, and has been shown to induce positive swallow-related brain changes in physiological studies as measured by increased cortical excitability. ","['patients with acute/sub-acute poststroke dysphagia', 'patients with dysphagia in acute/sub-acute stroke', 'Participants will be recruited from stroke units in Nottingham and Greater Manchester']","['Repetitive transcranial magnetic stimulation (rTMS', 'cerebellar rTMS', 'cerebellar rTMS or sham stimulation']","['severity of dysphagia', 'Dysphagia', 'pharyngeal motor evoked potential (MEP) amplitudes, (2) the functional oral intake score and dysphagia severity rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C0454856', 'cui_str': 'Greater Manchester (geographic location)'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",250.0,0.382892,"Repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum is a noninvasive technique requiring minimal physical or cognitive input from the patient, and has been shown to induce positive swallow-related brain changes in physiological studies as measured by increased cortical excitability. ","[{'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Wilkinson', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom; Stroke, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Sasegbon', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Centre (MAHSC)), Salford, United Kingdom.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Manchester Centre for Clinical Neurosciences, Division of Cardiovascular Sciences, University of Manchester, Salford Royal Hospital, Manchester Academic Health Sciences Centre (MAHSC), Salford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rothwell', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, University College London, United Kingdom.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom; Stroke, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Hamdy', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Centre (MAHSC)), Salford, United Kingdom. Electronic address: shaheen.hamdy@manchester.ac.uk.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2019.104586'] 714,31663925,A Novel Patient-Specific Model for Predicting Severe Oliguria; Development and Comparison With Kidney Disease: Improving Global Outcomes Acute Kidney Injury Classification.,"OBJECTIVES The Kidney Disease: Improving Global Outcomes urine output criteria for acute kidney injury lack specificity for identifying patients at risk of adverse renal outcomes. The objective was to develop a model that analyses hourly urine output values in real time to identify those at risk of developing severe oliguria. DESIGN This was a retrospective cohort study utilizing prospectively collected data. SETTING A cardiac ICU in the United Kingdom. PATIENTS Patients undergoing cardiac surgery between January 2013 and November 2017. INTERVENTIONS None. MEASUREMENT AND MAIN RESULTS Patients were randomly assigned to development (n = 981) and validation (n = 2,389) datasets. A patient-specific, dynamic Bayesian model was developed to predict future urine output on an hourly basis. Model discrimination and calibration for predicting severe oliguria (< 0.3 mL/kg/hr for 6 hr) occurring within the next 12 hours were tested in the validation dataset at multiple time points. Patients with a high risk of severe oliguria (p > 0.8) were identified and their outcomes were compared with those for low-risk patients and for patients who met the Kidney Disease: Improving Global Outcomes urine output criterion for acute kidney injury. Model discrimination was excellent at all time points (area under the curve > 0.9 for all). Calibration of the model's predictions was also excellent. After adjustment using multivariable logistic regression, patients in the high-risk group were more likely to require renal replacement therapy (odds ratio, 10.4; 95% CI, 5.9-18.1), suffer prolonged hospital stay (odds ratio, 4.4; 95% CI, 3.0-6.4), and die in hospital (odds ratio, 6.4; 95% CI, 2.8-14.0) (p < 0.001 for all). Outcomes for those identified as high risk by the model were significantly worse than for patients who met the Kidney Disease: Improving Global Outcomes urine output criterion. CONCLUSIONS This novel, patient-specific model identifies patients at increased risk of severe oliguria. Classification according to model predictions outperformed the Kidney Disease: Improving Global Outcomes urine output criterion. As the new model identifies patients at risk before severe oliguria develops it could potentially facilitate intervention to improve patient outcomes.",2020,Classification according to model predictions outperformed the Kidney Disease:,"['Kidney Disease', 'A cardiac ICU in the United Kingdom', 'Patients with a high risk of severe oliguria (p > 0.8', 'Patients undergoing cardiac surgery between January 2013 and November 2017']",[],"['suffer prolonged hospital stay', 'severe oliguria', 'die in hospital', 'renal replacement therapy']","[{'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028961', 'cui_str': 'Oligurias'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],"[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028961', 'cui_str': 'Oligurias'}, {'cui': 'C0420302', 'cui_str': 'Died in hospital (finding)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",,0.0530416,Classification according to model predictions outperformed the Kidney Disease:,"[{'ForeName': 'Samuel H', 'Initials': 'SH', 'LastName': 'Howitt', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oakley', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Caiado', 'Affiliation': 'Department of Mathematical Sciences, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Mathematical Sciences, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Malagon', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McCollum', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Stuart W', 'Initials': 'SW', 'LastName': 'Grant', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}]",Critical care medicine,['10.1097/CCM.0000000000004074'] 715,31189686,Protocol for a feasibility study of a cohort embedded randomised controlled trial comparing NE phron S paring T reatment (NEST) for small renal masses.,"INTRODUCTION Small renal masses (SRMs; ≤4 cm) account for two-thirds of new diagnoses of kidney cancer, the majority of which are incidental findings. The natural history of the SRM seems largely indolent. There is an increasing concern regarding surgical overtreatment and the associated health burden in terms of morbidity and economy. Observational data support the safety and efficacy of percutaneous cryoablation but there is an unmet need for high-quality evidence on non-surgical management options and a head-to-head comparison with standard of care is lacking. Historical interventional trial recruitment difficulties demand novel study conduct approaches. We aim to assess if a novel trial design, the cohort embedded randomised controlled trial (RCT), will enable carrying out such a comparison. METHODS AND ANALYSIS Single-centre prospective cohort study of adults diagnosed with SRM (n=200) with an open label embedded interventional RCT comparing nephron sparing interventions. Cohort participants will be managed at patient and clinicians' discretion and agree with longitudinal clinical data and biological sample collection, with invitation for trial interventions and participation in comparator control groups. Cohort participants with biopsy-proven renal cell carcinoma eligible for both percutaneous cryoablation and partial nephrectomy will be randomly selected (1:1) and invited to consider percutaneous cryoablation (n=25). The comparator group will be robotic partial nephrectomy (n=25). The primary outcome of this feasibility study is participant recruitment. Qualitative research techniques will assess barriers and recruitment improvement opportunities. Secondary outcomes are participant trial retention, health-related quality of life, treatment complications, blood transfusion rate, intensive care unit admission and renal replacement requirement rates, length of hospital stay, time to return to pre-treatment activities, number of work days lost, and health technologies costs. ETHICS AND DISSEMINATION Ethical approval has been granted (UK HRA REC 19/EM/0004). Study outputs will be presented and published. TRIAL REGISTRATION ISRCTN18156881; Pre-results.",2019,"Secondary outcomes are participant trial retention, health-related quality of life, treatment complications, blood transfusion rate, intensive care unit admission and renal replacement requirement rates, length of hospital stay, time to return to pre-treatment activities, number of work days lost, and health technologies costs. ","['small renal masses', 'adults diagnosed with SRM (n=200) with an open label embedded interventional RCT comparing nephron sparing interventions', 'Cohort participants with biopsy-proven renal cell carcinoma eligible for both']","['NE phron S paring T reatment (NEST', 'percutaneous cryoablation and partial nephrectomy', 'robotic partial nephrectomy', 'percutaneous cryoablation']","['participant trial retention, health-related quality of life, treatment complications, blood transfusion rate, intensive care unit admission and renal replacement requirement rates, length of hospital stay, time to return to pre-treatment activities, number of work days lost, and health technologies costs']","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0027713', 'cui_str': 'Nephrons'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy (procedure)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0752189', 'cui_str': 'Health Technology'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",200.0,0.316856,"Secondary outcomes are participant trial retention, health-related quality of life, treatment complications, blood transfusion rate, intensive care unit admission and renal replacement requirement rates, length of hospital stay, time to return to pre-treatment activities, number of work days lost, and health technologies costs. ","[{'ForeName': 'Joana B', 'Initials': 'JB', 'LastName': 'Neves', 'Affiliation': 'Department of Surgical Biotechnology, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cullen', 'Affiliation': 'Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Grant', 'Affiliation': 'Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Walkden', 'Affiliation': 'Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Bandula', 'Affiliation': 'Department of Interventional Radiology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Patki', 'Affiliation': 'Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Barod', 'Affiliation': 'Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Faiz', 'Initials': 'F', 'LastName': 'Mumtaz', 'Affiliation': 'Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aitchison', 'Affiliation': 'Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'Department of Applied Health Research, Institute of Epidemiology and Health, University College London, London, UK.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Ranieri', 'Affiliation': 'Tavistock and Portman NHS Foundation Trust, London, UK.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Surgical Biotechnology, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wildgoose', 'Affiliation': 'Patient Representative, London, UK.'}, {'ForeName': 'Kurinchi', 'Initials': 'K', 'LastName': 'Gurusamy', 'Affiliation': 'Department of Surgical Biotechnology, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, University College London, London, UK.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'Department of Surgical Biotechnology, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Maxine G B', 'Initials': 'MGB', 'LastName': 'Tran', 'Affiliation': 'Department of Surgical Biotechnology, Division of Surgery and Interventional Science, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030965'] 716,32067256,"Effect of ciclosporin on safety, lymphocyte kinetics and left ventricular remodelling in acute myocardial infarction.","AIMS Following a favourable pilot trial using a single bolus of ciclosporin, it has been unclear why 2 large studies (CYCLE and CIRCUS) failed to prevent reperfusion injury and reduce infarct size in STEMI (ST elevation myocardial infarction). The purpose of this study was to assess the effect of ciclosporin on myocardial injury, left ventricular remodelling and lymphocyte kinetics in patients with acute STEMI undergoing primary percutaneous coronary intervention. METHODS In this double-blind, single centre trial, we randomly assigned 52 acute STEMI patients with an onset of pain of <6 hours and blocked culprit artery to a single bolus of ciclosporin (n = 26) or placebo (n = 26, control group) prior to reperfusion by stent percutaneous coronary intervention. The primary endpoint was infarct size at 12 weeks. RESULTS Mean infarct size at 12 weeks was identical in both groups (9.1% [standard deviation= 7.0] vs 9.1% [standard deviation = 7.0], P = .99; 95% confidence interval for difference: -4.0 to 4.1). CD3 T-lymphocytes dropped to similar levels at 90 minutes (867 vs 852 cells/μL, control vs ciclosporin) and increased to 1454 vs 1650 cells/μL at 24 hours. CONCLUSION In our pilot trial, a single ciclosporin bolus did not affect infarct size or left ventricular remodelling, matching the results from CYCLE and CIRCUS. Our study suggests that ciclosporin does either not reach ischaemic cardiomyocytes, or requires earlier application during first medical contact. Finally, 1 bolus of ciclosporin is not sufficient to inhibit CD4 T-lymphocyte proliferation during remodelling. We therefore believe that further studies are warranted. (Evaluating the effectiveness of intravenous Ciclosporin on reducing reperfusion injury in pAtients undergoing PRImary percutaneous coronary intervention [CAPRI]; NCT02390674).",2020,"CD3 T-lymphocytes dropped to similar levels at 90 min (867 vs 852 cells/ul, control vs ciclosporin) and increased to 1454 vs 1650 cells/ul at 24h. ","['pAtients undergoing PRImary percutaneous coronary intervention [CAPRI', 'acute myocardial infarction', '52 acute STEMI patients with an onset of pain of less than 6 hours and blocked culprit artery to a single bolus of', 'n=26) or', 'patients with acute STEMI undergoing primary PCI']","['placebo', 'control group) prior to reperfusion by stent PCI', 'ciclosporin', 'Ciclosporin']","['Mean infarct size', 'infarct size at 12 weeks', 'safety, lymphocyte kinetics and left ventricular remodelling', 'infarct size or LV remodelling', 'CD3 T-lymphocytes', 'myocardial injury, LV-remodelling, and lymphocyte kinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301654', 'cui_str': 'Single bolus (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0600519', 'cui_str': 'Myocardial Remodeling, Ventricular'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",52.0,0.597496,"CD3 T-lymphocytes dropped to similar levels at 90 min (867 vs 852 cells/ul, control vs ciclosporin) and increased to 1454 vs 1650 cells/ul at 24h. ","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Cormack', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Mohammed', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Panahi', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Steel', 'Affiliation': 'Newcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle University, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chadwick', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, UK.'}, {'ForeName': 'Mohaned', 'Initials': 'M', 'LastName': 'Egred', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Stellos', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ioakim', 'Initials': 'I', 'LastName': 'Spyridopoulos', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/bcp.14252'] 717,32160043,EFFECT OF GLUTEN-FREE DIET ON METABOLIC CONTROL AND ANTHROPOMETRIC PARAMETERS IN TYPE 1 DIABETES WITH SUBCLINICAL CELIAC DISEASE: A RANDOMIZED CONTROLLED TRIAL.,"Objective: It is unclear whether the institution of gluten-free diet (GFD) is beneficial in patients with type 1 diabetes (T1DM) and subclinical celiac disease (CD). Our primary objective was to evaluate the effect of GFD on the frequency of hypoglycemia, in patients with T1DM and subclinical CD. Our secondary objective was to investigate the effect of GFD on height, weight, glycosylated hemoglobin (HbA1c), insulin dose requirement, and bone mineral homeostasis. Methods: We carried out a prospective open label randomized controlled trial (RCT). Patients with T1DM and subclinical CD were randomized to receive GFD or a normal diet for 1 year. The primary outcome was the frequency of hypoglycemic episodes (blood glucose <70 mg/dL) measured by self-monitoring of blood glucose (SMBG) at the sixth month of the study in the 2 groups. Results: Screening for CD was carried out in 320 T1DM patients. Thirty eligible patients were randomized to receive GFD (n = 15) or a normal diet (n = 15). The mean number of hypoglycemic episodes/month recorded by SMBG and the mean time spent in hypoglycemia measured by CGM (minutes) in the GFD group versus the non-GFD group at six months was 2.3 minutes versus 3.4 minutes ( P = .5) and 124.1 minutes versus 356.9 minutes ( P = .1), respectively. The mean number of hypoglycemic episodes/month significantly declined in the GFD group (3.5 episodes at baseline versus 2.3 episodes at the sixth month; P = .03). The mean HbA1c declined by 0.73% in the GFD group and rose by 0.99% in non-GFD group at study completion. Conclusion: This is the first RCT to assess the effect of GFD in T1DM and subclinical CD. A trend towards a decrease in hypoglycemic episodes and better glycemic control was seen in patients receiving GFD. Abbreviations: BMC = bone mineral content; BMI = body mass index; CD = celiac disease; CGM = continuous glucose monitoring; GFD = gluten-free diet; Hb = hemoglobin; HbA1c = glycosylated hemoglobin; iPTH = intact parathyroid hormone; RCT = randomized controlled trial; SMBG = self-monitoring of blood glucose; T1DM = type 1 diabetes mellitus; tTG-IgA = tissue transglutaminase immunoglobulin A.",2020,"Mean HbA1c declined by 0.73% in GFD group and rose by 0.99% in non GFD group, at study completion. ","['patients with type 1 diabetes (T1DM) and subclinical celiac disease (CD', '30 eligible patients', '320 T1DM patients were screened for CD', 'patients with T1DM and subclinical CD', 'Patients with T1DM and subclinical CD']","['GFD', 'gluten free diet (GFD', 'normal diet']","['Mean number of hypoglycemic episodes/month recorded by SMBG and mean time spent in hypoglycemia', 'Mean HbA1c', 'height, weight, glycosylated hemoglobin (HbA1c), insulin dose requirement and bone mineral homeostasis', 'Mean number of hypoglycemic episodes', 'hypoglycemic episodes and better glycemic control', 'frequency of hypoglycemia', 'frequency of hypoglycemic episodes (blood glucose< 70 mg/dl) measured by self-monitoring of blood glucose (SMBG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}]",30.0,0.0696382,"Mean HbA1c declined by 0.73% in GFD group and rose by 0.99% in non GFD group, at study completion. ","[{'ForeName': 'Parjeet', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Agarwala', 'Affiliation': ''}, {'ForeName': 'Govind', 'Initials': 'G', 'LastName': 'Makharia', 'Affiliation': ''}, {'ForeName': 'Shinjini', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': ''}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': ''}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0479'] 718,32119677,Surgical decision making in the setting of severe traumatic brain injury: A survey of neurosurgeons.,"BACKGROUND Surgical decision-making in severe traumatic brain injury (TBI) is complex. Neurosurgeons weigh risks and benefits of interventions that have the potential to both maximize the chance of recovery and prolong suffering. Inaccurate prognostication can lead to over- or under-estimation of outcomes and influence treatment recommendations. OBJECTIVE To evaluate the impact of evidence-based risk estimates on neurosurgeon treatment recommendations and prognostic beliefs in severe TBI. METHODS In a survey-based randomized experiment, a total of 139 neurosurgeons were presented with two hypothetical patient with severe TBI and subdural hematoma; the intervention group received additional evidence-based risk estimates for each patient. The main outcome was neurosurgeon treatment recommendation of non-surgical management. Secondary outcomes included prediction of functional recovery at six months. RESULTS In the first patient scenario, 22% of neurosurgeons recommended non-surgical management and provision of evidence-based risk estimates increased the propensity to recommend non-surgical treatment (odds ratio [OR]: 2.81, 95% CI: 1.21-6.98; p = 0.02). Neurosurgeon prognostic beliefs of 6-month functional recovery were variable in both control (median 20%, IQR: 10%-40%) and intervention (30% IQR: 10%-50%) groups and neurosurgeons were less likely to recommend non-surgical management when they believed prognosis was favorable (odds ratio [OR] per percentage point increase in 6-month functional recovery: 0.97, 95% confidence interval [CI]: 0.95-0.99). The results for the second patient scenario were qualitatively similar. CONCLUSIONS Our findings show that the provision of evidence-based risk predictions can influence neurosurgeon treatment recommendations and prognostication, but the effect is modest and there remains large variability in neurosurgeon prognostication.",2020,"groups and neurosurgeons were less likely to recommend non-surgical management when they believed prognosis was favorable (odds ratio [OR] per percentage point increase in 6-month functional recovery: 0.97, 95% confidence interval [CI]: 0.95-0.99).","['139 neurosurgeons were presented with two hypothetical patient with severe TBI and subdural hematoma', 'severe traumatic brain injury']",[],"['prediction of functional recovery at six months', 'Neurosurgeon prognostic beliefs of 6-month functional recovery', 'neurosurgeon treatment recommendation of non-surgical management']","[{'cui': 'C0237427', 'cui_str': 'Neurological Surgeons'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0475059', 'cui_str': 'Subdural Hematoma, Traumatic'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0237427', 'cui_str': 'Neurological Surgeons'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",139.0,0.189545,"groups and neurosurgeons were less likely to recommend non-surgical management when they believed prognosis was favorable (odds ratio [OR] per percentage point increase in 6-month functional recovery: 0.97, 95% confidence interval [CI]: 0.95-0.99).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Williamson', 'Affiliation': 'Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Ryser', 'Affiliation': 'Department of Population Health Sciences, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Abdelgadir', 'Affiliation': 'Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Lemmon', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Mary Carol', 'Initials': 'MC', 'LastName': 'Barks', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Rasheedat', 'Initials': 'R', 'LastName': 'Zakare', 'Affiliation': 'Duke School of Medicine, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ubel', 'Affiliation': 'Duke School of Medicine, Duke University, Durham, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0228947'] 719,32119700,Depth of acid penetration and enamel surface roughness associated with different methods of interproximal enamel reduction.,"OBJECTIVES To assess and compare the enamel surface quality after interproximal enamel reduction (IPR) was performed with different systems and to study the relation between acid penetration depth and enamel surface quality as well as the importance of remineralization. METHODS Sixty-five extracted teeth were randomly allocated to five experimental groups: untreated control, manual with New Metal Strips, mechanical with oscillating segment (OS) discs, Safe-Tipped Bur Kit, and the Ortho-Strip, followed by 30 s of polishing with the Softflex system and the Compo-system after treating the tooth with OS discs. Mesial surfaces were demineralized for 24 h and distal surfaces were subjected to interchanging demineralization and remineralization cycles of 24 h each for 18 days. The analysis was carried out by profilometry, scanning electron microscopy, and polarization microscopy. RESULTS After IPR and polishing, enamel roughness was reduced for all systems tested except for the Essix Safe-Tipped Bur Kit. Subsequent demineralization increased enamel roughness in all groups except controls beyond the original level prior to IPR except for IPR with New Metal Strips or Ortho-Strips and subsequent polishing. Cyclic demineralization and remineralization for 18 days yielded a reduction in acid penetration depth and an increase in surface smoothness, which correlated with each other only for controls and treatment with New Metal Strips or Ortho-Strips. CONCLUSIONS Manual IPR, using New Metal Strips and, even more, the oscillating IPR system Ortho-Strips, yielded smoother interproximal enamel surfaces and less acid penetration depth than the IPR systems with OS discs and the Safe-Tipped Bur Kit after polishing and 18 days of cyclic demineralization and remineralization. Irrespective of the IPR procedure, proper remineralization of IPR-treated surfaces is advisable to reduce caries susceptibility.",2020,"After IPR and polishing, enamel roughness was reduced for all systems tested except for the Essix Safe-Tipped Bur Kit.",['Sixty-five extracted teeth'],"['untreated control, manual with New Metal Strips, mechanical with oscillating segment (OS) discs, Safe-Tipped Bur Kit, and the Ortho-Strip, followed by 30 s of polishing with the Softflex system and the Compo-system', 'interproximal enamel reduction (IPR']","['enamel roughness', 'acid penetration depth', 'surface smoothness', 'enamel surface quality']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0700351', 'cui_str': 'Bur (physical object)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",65.0,0.0219832,"After IPR and polishing, enamel roughness was reduced for all systems tested except for the Essix Safe-Tipped Bur Kit.","[{'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Danesh', 'Affiliation': 'Department of Orthodontics, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Pascal Kai Konstantin', 'Initials': 'PKK', 'LastName': 'Podstawa', 'Affiliation': 'Department of Orthodontics, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Cate-Emilia', 'Initials': 'CE', 'LastName': 'Schwartz', 'Affiliation': 'Department of Orthodontics, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kirschneck', 'Affiliation': 'Department of Orthodontics, University Medical Centre of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Bizhang', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Arnold', 'Affiliation': 'Department of Biological and Material Sciences in Dentistry, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}]",PloS one,['10.1371/journal.pone.0229595'] 720,32066605,Protocol for the feasibility and acceptability of a brief routine weight management intervention for postnatal women embedded within the national child immunisation programme: randomised controlled cluster feasibility trial with nested qualitative study (PIMMS-WL).,"INTRODUCTION On average women retain 5 to 9 kg 1 year after giving birth which can increase the risk of later obesity and chronic diseases. Some previous trials in this population have been effective in reducing weight, but are too intensive and costly to deliver at scale. There is a need for low-cost interventions to facilitate weight loss in this population. METHODS AND ANALYSIS The primary aim is to assess the feasibility of delivering a weight management intervention for overweight/obese postnatal women within child immunisation appointments. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. General practitioner practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. Eighty women will be recruited. The intervention group will be offered brief support that encourages self-management of weight when attending child immunisation appointments. Practice nurses will encourage women to weigh themselves weekly and record this, and to make healthy lifestyle choices through using an online weight management programme. Women will be advised to aim for 0.5 to 1 kg/week weight loss. At each child immunisation the nurse will assess progress by weighing women. The comparator group will receive a healthy lifestyle leaflet. Data on weight, body fat, depression, anxiety, body image, eating behaviours and physical activity will be collected at baseline and follow-up. Women and nurses will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on prespecified stop-go criteria. ETHICS AND DISSEMINATION Data will be stored securely at the University of Birmingham. Results will be disseminated through academic publications and presentations and will inform a possible phase III trial. The National Research Ethics Committee approved the study protocol. TRIAL REGISTRATION NUMBER ISRCTN12209332.",2020,"Data on weight, body fat, depression, anxiety, body image, eating behaviours and physical activity will be collected at baseline and follow-up.","['overweight/obese postnatal women within child immunisation appointments', 'Eighty women will be recruited', 'postnatal women embedded within the national child immunisation programme']","['routine weight management intervention', 'healthy lifestyle leaflet', 'weight management intervention']","['weight, body fat, depression, anxiety, body image, eating behaviours and physical activity', 'risk of later obesity and chronic diseases']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]",80.0,0.119087,"Data on weight, body fat, depression, anxiety, body image, eating behaviours and physical activity will be collected at baseline and follow-up.","[{'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Parretti', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, Public Health Building, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Birmingham Clinical Trials Unit, Public Health Building, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vince', 'Affiliation': 'Birmingham Clinical Trials Unit, Public Health Building, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Department of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Ruth V', 'Initials': 'RV', 'LastName': 'Pritchett', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK a.daley@lboro.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033027'] 721,32066607,"Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial.","INTRODUCTION People with diabetes are often associated with multifaceted factors and comorbidities. Diabetes management frameworks need to integrate a biopsychosocial, patient-centred approach. Despite increasing efforts in promotion and diabetes education, interventions integrating both physical and mental health components are still lacking in Malaysia. The Optimal Health Programme (OHP) offers an innovative biopsychosocial framework to promote overall well-being and self-efficacy, going beyond education alone and has been identified as relevant within the primary care system. Following a comprehensive cultural adaptation process, Malaysia's first OHP was developed under the name 'Pohon Sihat' (OHP). The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus. METHODS AND ANALYSIS This biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed. ETHICS AND DISSEMINATION This study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT03601884.",2020,"The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus. ","['patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia', 'primary care patients with diabetes mellitus', 'engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya']","['Health Programme (OHP', 'culturally adapted biopsychosocial intervention (POHON SIHAT', 'OHP', 'mental health-based self-management and wellness programme']","['self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.124889,"The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus. ","[{'ForeName': 'Aida Farhana', 'Initials': 'AF', 'LastName': 'Suhaimi', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Putrajaya Malaysia, Selangor, Malaysia aida.hjsuhaimi@gmail.com.'}, {'ForeName': 'Normala', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.'}, {'ForeName': 'Kit-Aun', 'Initials': 'KA', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.'}, {'ForeName': 'Umi Adzlin', 'Initials': 'UA', 'LastName': 'Silim', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Gaye', 'Initials': 'G', 'LastName': 'Moore', 'Affiliation': ""Centre for Palliative Care, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Brigid', 'Initials': 'B', 'LastName': 'Ryan', 'Affiliation': ""International Unit, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': ""Department of Psychiatry, St. Vincent's Mental Health, Melbourne, Victoria, Australia.""}]",BMJ open,['10.1136/bmjopen-2019-033920'] 722,32066608,Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial.,"INTRODUCTION Patellar tendinopathy is a degenerative disease of the patellar tendon, which affects athletes from a variety of sports, and is especially predominant in sports involving high-impact jumping. The aim of this study is to determine the additional effect of two interventions combined with eccentric exercise and compare which one is the most effective at short-term and long-term follow-up for patients with patellar tendinopathy. METHODS AND ANALYSIS This study is a randomised controlled trial with blinded participants. Measurements will be carried out by a specially trained blinded assessor. A sample of 57 patients with a medical diagnosis of patellar tendinopathy will participate in this study and will be divided into three treatment groups. Eligible participants will be randomly allocated to receive either: (a) treatment group with percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling. In addition, all groups will perform eccentric exercise. Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively. Participants will be assessed at baseline, at 10 weeks and at 22 weeks after baseline. The expected findings will allow us to advance in the treatment of this injury, as they will help determine whether a needling intervention has additional effects on an eccentric exercise programme and whether any of the needling modalities is more effective than the other. ETHICS AND DISSEMINATION This protocol has been approved by the Ethics Committee of Aragon (N° PI15/0017). The trial will be conducted in accordance with the Declaration of Helsinki. TRIAL REGISTRATION NUMBER NCT02498795.",2020,"Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively.","['patients with patellar tendinopathy', 'Eligible participants', 'patellar tendinopathy', '57 patients with a medical diagnosis of patellar tendinopathy']","['eccentric exercise', 'percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling']","['Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",57.0,0.19379,"Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively.","[{'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'López-Royo', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Facultad de Ciencias de la Salud y del Deporte, Universidad de Zaragoza, Campus de Huesca, Aragón, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ortiz-Lucas', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Rita Maria', 'Initials': 'RM', 'LastName': 'Galán-Díaz', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Ana Vanessa', 'Initials': 'AV', 'LastName': 'Bataller-Cervero', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Boloushi', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'Hamam-Alcober', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain pherrero@usj.es.'}]",BMJ open,['10.1136/bmjopen-2019-034304'] 723,32075830,Economic evaluation of the OSAC randomised controlled trial: oral corticosteroids for non-asthmatic adults with acute lower respiratory tract infection in primary care.,"OBJECTIVE To estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo. DESIGN Cost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work. SETTING Fifty-four National Health Service (NHS) general practices in England. PARTICIPANTS 398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days. INTERVENTIONS 2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets. OUTCOME MEASURES Quality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up. RESULTS 198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean 'profit' to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms. CONCLUSIONS The use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms. TRIAL REGISTRATION NUMBERS EudraCT 2012-000851-15 and ISRCTN57309858; Pre-results.",2020,"There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms. ","['non-asthmatic adults with acute lower respiratory tract infection in primary care', '398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days', 'non-asthmatic adults with ALRTI', ""of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean 'profit' to the NHS of £7.00"", 'Fifty-four National Health Service (NHS) general practices in England', 'asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with']","['intervention (prednisolone', 'placebo', 'mg oral prednisolone', 'corticosteroids', 'prednisolone']","['duration of cough or severity of symptoms', 'quality adjusted life years gain', 'quality of life and cost savings', 'Quality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom', 'prescription charges', 'NHS costs']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection (disorder)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0034380'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",398.0,0.499634,"There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms. ","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Moure-Fernandez', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK aidamoure@gmail.com.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hollinghurst', 'Affiliation': 'Centre for Academic Primary Care, University of Bristol, Bristol, UK.'}, {'ForeName': 'Fran E', 'Initials': 'FE', 'LastName': 'Carroll', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Downing', 'Affiliation': 'Centre for Academic Primary Care, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Brookes', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'May', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Gohary', 'Affiliation': 'Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harnden', 'Affiliation': 'Nuffield Department of Primay Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Natasher', 'Initials': 'N', 'LastName': 'Lafond', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Orton', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'Department of Family Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Timmins', 'Affiliation': 'Nuffield Department of Primay Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Nuffield Department of Primay Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033567'] 724,32075832,"Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial.","INTRODUCTION Problematic benzodiazepine use is a global health issue. Although the adverse side effects of long-term use of benzodiazepines are well known, it remains difficult to implement interventions for discontinuation in primary care. Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim of this study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD) use in the long term and evaluate the implementation process. METHODS AND ANALYSIS This study is a multicentre, pragmatic, cluster randomised controlled trial with 1200 patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of the general practice in a 1:1 ratio using a block randomisation system stratified per language. The study population consists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6 months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine. Secondary outcomes include discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach. The process of implementing blended care will be evaluated in a nested study. ETHICS AND DISSEMINATION This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (ref. S61194). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER NCT03937180.",2020,"Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice.","['adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6\u2009months', 'sleeping problems in primary care', '1200 patients, included by 120 general practitioners']","['blended care programme', 'benzodiazepines', 'benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD', 'benzodiazepine']","['proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine', 'discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033139', 'cui_str': 'Primary Insomnia'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C0251504', 'cui_str': 'zaleplon'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205472', 'cui_str': 'Toxicologic (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0042037'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",1200.0,0.169347,"Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice.","[{'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Coteur', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium kristien.coteur@kuleuven.be.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Van Nuland', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vanmeerbeek', 'Affiliation': 'Department of General Practice, Université de Liège, Liege, Belgium.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Henrard', 'Affiliation': 'Department of General Practice, Université de Liège, Liege, Belgium.'}, {'ForeName': 'Sibyl', 'Initials': 'S', 'LastName': 'Anthierens', 'Affiliation': 'Department of General Practice, University of Antwerp, Antwerpen, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Van den Broeck', 'Affiliation': 'Department of General Practice, University of Antwerp, Antwerpen, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'De Sutter', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Gent, Belgium.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Creupelandt', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Gent, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Devroey', 'Affiliation': 'Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Van Overmeire', 'Affiliation': 'Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Offermans', 'Affiliation': 'Department of General Medicine, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kacenelenbogen', 'Affiliation': 'Department of General Medicine, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Annouschka', 'Initials': 'A', 'LastName': 'Laenen', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics, Leuven, Belgium.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Mathei', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.'}]",BMJ open,['10.1136/bmjopen-2019-033688'] 725,32075834,Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial.,"INTRODUCTION Restless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD). METHODS AND ANALYSIS This is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes. ETHICS AND DISSEMINATION The study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03817554.",2020,"We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes. ","['ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital', '104 patients with uremic RLS receiving PD will be enrolled from four hospitals', 'patients with uremic RLS receiving peritoneal dialysis (PD', 'peritoneal dialysis patients with restless legs syndrome (RLS', 'patients with end stage renal disease']","['placebo', 'Pramipexole', 'pramipexole', 'placebo or pramipexole']","['psychological status, sleep disorder and quality of life and blood pressure', 'efficacy and safety']","[{'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0035258', 'cui_str': 'Wittmaack Ekbom Syndrome'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074710', 'cui_str': 'Pramipexole'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0034380'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",104.0,0.745715,"We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes. ","[{'ForeName': 'Tian-Tian', 'Initials': 'TT', 'LastName': 'Ma', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Zhikai', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Nephrology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Sainan', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Statistics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jing-Hong', 'Initials': 'JH', 'LastName': 'Zhao', 'Affiliation': 'Renal Division, Department of Medicine, Xinqiao Hospital, Chongqing, Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Renal Division, Department of Medicine, Xinqiao Hospital, Chongqing, Sichuan, China.'}, {'ForeName': 'Fu-Yun', 'Initials': 'FY', 'LastName': 'Sun', 'Affiliation': 'Renal Division, Department of Medicine, Cang Zhou Central Hospital, Cang Zhou, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Renal Division, Department of Medicine, Cang Zhou Central Hospital, Cang Zhou, China.'}, {'ForeName': 'Zu-Ying', 'Initials': 'ZY', 'LastName': 'Xiong', 'Affiliation': 'Renal Division, Department of Medicine, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Zi-Bo', 'Initials': 'ZB', 'LastName': 'Xiong', 'Affiliation': 'Renal Division, Department of Medicine, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Peking University First Hospital, Beijing, China jie.dong@bjmu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-033815'] 726,32075835,Recovery from recurrent depression with mindfulness-based cognitive therapy and antidepressants: a qualitative study with illustrative case studies.,"OBJECTIVES This study aimed to describe the recovery journeys of people with a history of recurrent depression who took part in a psychosocial programme designed to teach skills to prevent depressive relapse (mindfulness-based cognitive therapy (MBCT)), alongside maintenance antidepressant medication (ADM). DESIGN A qualitative study embedded within a multicentre, single blind, randomised controlled trial (the PREVENT trial). SETTING Primary care urban and rural settings in the UK. PARTICIPANTS 42 people who participated in the MBCT arm of the parent trial were purposively sampled to represent a range of recovery journeys. INTERVENTIONS MBCT involves eight weekly group sessions, with four refresher sessions offered in the year following the end of the programme. It was adapted to offer bespoke support around ADM tapering and discontinuation. METHODS Written feedback and structured in-depth interviews were collected in the 2 years after participants undertook MBCT. Data were analysed using thematic analysis and case studies constructed to illustrate the findings. RESULTS People with recurrent depression have unique recovery journeys that shape and are shaped by their pharmacological and psychological treatment choices. Their journeys typically include several over-arching themes: (1) beliefs about the causes of depression, both biological and psychosocial; (2) personal agency, including expectations about their role in recovery and treatment; (3) acceptance, both of depression itself and the recovery journey; (4) quality of life; (5) experiences and perspectives on ADM and ADM tapering-discontinuation; and (6) the role of general practitioners, both positive and negative. CONCLUSIONS People with recurrent depression describe unique, complex recovery journeys shaped by their experiences of depression, treatment and interactions with health professionals. Understanding how several themes coalesce for each individual can both support their recovery and treatment choices as well as health professionals in providing more accessible, collaborative, individualised and empowering care. TRIAL REGISTRATION NUMBER Clinical trial number ISRCTN26666654; post results.",2020,"Understanding how several themes coalesce for each individual can both support their recovery and treatment choices as well as health professionals in providing more accessible, collaborative, individualised and empowering care. ","['People with recurrent depression', 'people with a history of recurrent depression who took part in a', '42 people who participated in the MBCT arm of the parent trial were purposively sampled to represent a range of recovery journeys', 'Primary care urban and rural settings in the UK']","['psychosocial programme designed to teach skills to prevent depressive relapse (mindfulness-based cognitive therapy (MBCT)), alongside maintenance antidepressant medication (ADM', 'MBCT', 'mindfulness-based cognitive therapy and antidepressants']","['expectations about their role in recovery and treatment; (3) acceptance, both of depression itself and the recovery journey; (4) quality of life; (5) experiences and perspectives on ADM and ADM tapering-discontinuation; and (6) the role of general practitioners, both positive and negative']","[{'cui': 'C0221480', 'cui_str': 'Recurrent depression (disorder)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}]","[{'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",42.0,0.0519692,"Understanding how several themes coalesce for each individual can both support their recovery and treatment choices as well as health professionals in providing more accessible, collaborative, individualised and empowering care. ","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Tickell', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Byng', 'Affiliation': 'Peninsula Medical School, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Gradinger', 'Affiliation': 'Peninsula Medical School, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Department of Education, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cardy', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Weaver', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morant', 'Affiliation': 'Department of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK willem.kuyken@psych.ox.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033892'] 727,32029495,"NET-02 trial protocol: a multicentre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC).","INTRODUCTION Poorly differentiated (PD), extrapulmonary (EP), neuroendocrine carcinomas (NECs) are rare but aggressive neuroendocrine neoplasms. First-line treatment for advanced disease is an etoposide and platinum-based chemotherapy combination. There is no established second-line treatment for patients with PD-EP-NEC, and this is an area of unmet need. METHODS AND ANALYSIS NET-02 is a UK, multicentre, randomised (1:1), parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive PD-EP-NEC. One hundred and two eligible participants will be randomised to receive either nal-IRI/5-FU/folinic acid or docetaxel. The primary objective is to determine the 6-month progression-free survival (PFS) rate. The secondary objectives of this study are to determine PFS, overall survival, objective response rate, toxicity, quality of life and whether neuron-specific enolase is predictive of treatment response. If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial. If both treatments meet this target, prespecified selection criteria will be applied to establish which treatment to take forward. ETHICS AND DISSEMINATION This study has ethical approval from the Greater Manchester Central Research Ethics Committee (reference no. 18/NW/0031) and clinical trial authorisation from the Medicine and Healthcare Products Regulatory Agency. Results will be published in peer-reviewed journals and uploaded to the European Union Clinical Trials Register. TRIAL REGISTRATION NUMBERS ISRCTN10996604, NCT03837977, EudraCT Number: 2017-002453-11.",2020,"If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial.","['patients with progressive PD-EP-NEC', 'One hundred and two eligible participants', 'patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC']","['liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy', 'nal-IRI/5-FU/folinic acid or docetaxel', 'liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy', 'etoposide and platinum-based chemotherapy combination']","['PFS rate', 'PFS, overall survival, objective response rate, toxicity, quality of life', '6-month progression-free survival (PFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated (qualifier value)'}, {'cui': 'C0206695', 'cui_str': 'Carcinoma, Neuroendocrine'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",102.0,0.182193,"If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial.","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Craig', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Swain', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Batman', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Department of Oncology, Weston Park Hospital, Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Glasgow, UK.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Cave', 'Affiliation': 'Department of Oncology, University Hospital Southampton NHS Foundation Trust, Southampton, Southampton, UK.'}, {'ForeName': 'Rohini', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, Royal Marsden Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Department of Oncology, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lamarca', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hubner', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Debashis', 'Initials': 'D', 'LastName': 'Sarker', 'Affiliation': ""Comprehensive Cancer Centre, King's College Hospital, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Department of Oncology, University College London Cancer Institute, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Howard', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK Mairead.McNamara@christie.nhs.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034527'] 728,32029498,Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial.,"INTRODUCTION Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). METHODS AND ANALYSIS This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE. ETHICS AND DISSEMINATION The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER The Netherlands Trial Registry (NL8029); Pre-results.",2020,"This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). ",['Patients undergoing an LSG are included after obtaining informed consent'],"['TXA', 'tranexamic acid', 'Tranexamic acid (TXA', 'placebo infusion and (2) administration of 1500\u2009mg TXA', 'laparoscopic sleeve gastrectomy (LSG', 'placebo', 'sleeve gastrectomy (PATAS']","['rates of VTE', 'preoperative and postoperative haemorrhage rates', 'rates of venous thromboembolic events (VTEs', 'preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage', 'haemorrhage rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low (finding)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.447315,"This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). ","[{'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands m.leeman@franciscus.nl.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Huisbrink', 'Affiliation': 'Pharmacology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Julie M A', 'Initials': 'JMA', 'LastName': 'Wijnand', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'L Ulas', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Serge J C', 'Initials': 'SJC', 'LastName': 'Verbrugge', 'Affiliation': 'Anaesthesiology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-034572'] 729,32029497,Computerised cognitive training to improve cognition including delirium following coronary artery bypass grafting surgery: protocol for a blinded randomised controlled trial.,"INTRODUCTION Coronary artery bypass grafting (CABG) surgery is known to improve vascular function and cardiac-related mortality rates; however, it is associated with high rates of postoperative cognitive decline and delirium. Previous attempts to prevent post-CABG cognitive decline using pharmacological and surgical approaches have been largely unsuccessful. Cognitive prehabilitation and rehabilitation are a viable yet untested option for CABG patients. We aim to investigate the effects of preoperative cognitive training on delirium incidence, and preoperative and postoperative cognitive training on cognitive decline at 4 months post-CABG. METHODS AND ANALYSIS This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia. Those in the intervention group will complete 1-2 weeks of CCT preoperatively (45-60 min sessions, 3.5 sessions/week) and 12 weeks of CCT postoperatively (commencing 1 month following surgery, 45-60 min sessions, 3 sessions/week). All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1 year. The primary delirium outcome variable will be delirium incidence (presence vs absence); the primary cognitive decline variable will be at 4 months (significant decline vs no significant decline/improvement from baseline). Logistic regression modelling will be used, with age and gender as covariates. Secondary outcomes include cognitive decline from baseline to discharge, and at 6 months and 1 year post-CABG. ETHICS AND DISSEMINATION Ethics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee (South Australia, Australia) and the University of South Australia Human Ethics Committee, with original approval obtained on 13 December 2017. It is anticipated that approximately two to four publications and multiple conference presentations (national and international) will result from this research. TRIAL REGISTRATION NUMBER This clinical trial is registered with the Australian New Zealand Clinical Trials Registry and relates to the pre-results stage. Registration number: ACTRN12618000799257.",2020,"This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia.","['older adults undergoing CABG in Adelaide, South Australia', 'Registration number', 'CABG patients', 'All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1\u2009year']","['Coronary artery bypass grafting (CABG) surgery', 'Computerised cognitive training', 'computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group', 'preoperative cognitive training', 'coronary artery bypass grafting surgery']","['delirium incidence (presence vs absence); the primary cognitive decline', 'cognition including delirium', 'cognitive decline from baseline to discharge, and at 6\u2009months and 1\u2009year post-CABG']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]",,0.225326,"This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greaves', 'Affiliation': 'Cognitive Ageing and Impairment Neurosciences Laboratory (CAIN), School of Psychology, Social Work and Social Policy, University of South Australia Division of Education, Arts and Social Sciences, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Psaltis', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lampit', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel H J', 'Initials': 'DHJ', 'LastName': 'Davis', 'Affiliation': 'MRC Unit for Lifelong Health and Ageing, University College London, London, UK.'}, {'ForeName': 'Ashleigh E', 'Initials': 'AE', 'LastName': 'Smith', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Division of Health Sciences, Adelaide, South Australia, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Bourke', 'Affiliation': 'Department of Geriatric and Rehabilitation Medicine, Royal Adelaide Hospital, Central Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Worthington', 'Affiliation': 'Department of Cardiothoracic Surgery, Royal Adelaide Hospital, Central Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Valenzuela', 'Affiliation': 'Brain and Mind Centre and Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hannah A D', 'Initials': 'HAD', 'LastName': 'Keage', 'Affiliation': 'Cognitive Ageing and Impairment Neurosciences Laboratory (CAIN), School of Psychology, Social Work and Social Policy, University of South Australia Division of Education, Arts and Social Sciences, Adelaide, South Australia, Australia Hannah.Keage@unisa.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034551'] 730,31926623,Effects of diets high in animal or plant protein on oxidative stress in individuals with type 2 diabetes: A randomized clinical trial.,"High-protein diet is a promising strategy for diabetes treatment supporting body weight control, improving glycaemic status, cardiovascular risk factors and reducing liver fat. Here, we investigated effects of diets high in animal (AP) or plant (PP) protein on oxidative stress and antioxidant status in individuals with type 2 diabetes (T2DM). 37 obese individuals (age 64.3 ± 1.0 years) with T2DM were randomized to an isocaloric diet (30 energy(E)% protein, 30 E% fat and 40 E% carbohydrates) rich in AP or PP for 6 weeks. Markers of oxidative and nitrosative stress and antioxidant status in plasma and nitrate/nitrite levels in urine were assessed. Gene expression in subcutaneous adipose tissue (SAT) was analysed by RNA-Seq and real-time PCR. Both AP and PP diets similarly reduced plasma levels of malondialdehyde (P AP  = 0.003, P PP  = 1.6 × 10 -4 ) and protein carbonyls (P AP  = 1.2 × 10 -4 , P PP  = 3.0 × 10 -5 ) over 6 weeks. Nitrotyrosine (NT) increased upon both AP and PP diets (P AP  = 0.005, P PP  = 0.004). SAT expression of genes involved in nitric oxide (NO) and oxidative stress metabolism and urine NO metabolite (nitrate/nitrite) levels were not changed upon both diets. Plasma levels of carotenoids increased upon PP diet, whereas retinol, alpha- and gamma-tocopherol slightly decreased upon both diets. AP and PP diets similarly improve oxidative stress but increase nitrosative stress markers in individuals with T2DM. Mechanisms of the NT regulation upon high-protein diets need further investigation.",2020,"Both AP and PP diets similarly reduced plasma levels of malondialdehyde (P AP  = 0.003, P PP  = 1.6 ","['individuals with type 2 diabetes (T2DM', '37 obese individuals (age 64.3\xa0±\xa01.0 years) with T2DM', 'individuals with type 2 diabetes', 'individuals with T2DM']","['AP and PP diets', 'diets high in animal (AP) or plant (PP) protein', 'isocaloric diet (30 energy(E)% protein, 30\xa0E% fat and 40\xa0E% carbohydrates) rich in AP or PP', 'diets high in animal or plant protein', 'High-protein diet']","['protein carbonyls', 'Gene expression in subcutaneous adipose tissue (SAT', 'NO metabolite (nitrate/nitrite) levels', 'Nitrotyrosine (NT', 'SAT expression of genes involved in nitric oxide (NO) and oxidative stress metabolism and urine', 'retinol, alpha- and gamma-tocopherol slightly', 'Markers of oxidative and nitrosative stress and antioxidant status in plasma and nitrate/nitrite levels', 'oxidative stress and antioxidant status', 'nitrosative stress markers', 'plasma levels of malondialdehyde', 'Plasma levels of carotenoids', 'oxidative stress']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0032089', 'cui_str': 'Plant Proteins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0425403', 'cui_str': 'Diet, High-Protein'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0042037'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017054', 'cui_str': '3,4-Dihydro-2,7,8-trimethyl-2-(4,8,12-trimethyltridecyl)-2H-1-benzopyran-6-ol'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C4505047', 'cui_str': 'Nitrosative Stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}]",37.0,0.0299442,"Both AP and PP diets similarly reduced plasma levels of malondialdehyde (P AP  = 0.003, P PP  = 1.6 ","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pivovarova-Ramich', 'Affiliation': 'Dept. of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; Reseach Group Molecular Nutritional Medicine, Dept. of Molecular Toxicology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; German Center for Diabetes Research (DZD), München-Neuherberg, Germany; Dept. of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University of Medicine, Berlin, Germany. Electronic address: olga.ramich@dife.de.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Markova', 'Affiliation': 'Dept. of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'NutriAct-Competence Cluster Nutrition Research Berlin-Potsdam, Nuthetal, Germany; Department of Molecular Toxicology, German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), Nuthetal, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sucher', 'Affiliation': 'Dept. of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Hornemann', 'Affiliation': 'Dept. of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rudovich', 'Affiliation': 'Dept. of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; German Center for Diabetes Research (DZD), München-Neuherberg, Germany; Dept. of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University of Medicine, Berlin, Germany; Division of Endocrinology and Diabetes, Department of Internal Medicine, Spital Bülach, Bülach, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Raila', 'Affiliation': 'Institute of Nutritional Science, University of Potsdam, Nuthetal, Germany.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Sunaga-Franze', 'Affiliation': 'Max Delbrück Center for Molecular Medicine (MDC) in the Helmholtz Society, Berlin, Germany and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Sauer', 'Affiliation': 'Max Delbrück Center for Molecular Medicine (MDC) in the Helmholtz Society, Berlin, Germany and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Rohn', 'Affiliation': 'Institute for Food and Environmental Research e.V, Bad Belzig, Germany; Institute of Food Chemistry, Hamburg School of Food Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'Dept. of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany; German Center for Diabetes Research (DZD), München-Neuherberg, Germany; Dept. of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University of Medicine, Berlin, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Grune', 'Affiliation': 'German Center for Diabetes Research (DZD), München-Neuherberg, Germany; NutriAct-Competence Cluster Nutrition Research Berlin-Potsdam, Nuthetal, Germany; Department of Molecular Toxicology, German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), Nuthetal, Germany; Institute of Nutritional Science, University of Potsdam, Nuthetal, Germany; German Center for Cardiovascular Research (DZHK), Berlin, Germany.'}]",Redox biology,['10.1016/j.redox.2019.101397'] 731,31441769,Adult Health Status Among Native American Families Participating in the Growing Resilience Home Garden Study.,"Northern Arapaho and Eastern Shoshone tribes sharing the Wind River Indian Reservation (WRIR) in Wyoming reportedly die 30 years earlier than whites in the state. We analyzed data on the health status of 176 adults from 96 families who participated in a randomized controlled trial to assess health effects of home gardens. Measures of body mass index, waist circumference, blood pressure, hemoglobin A1c, vitamin D, low-density lipoprotein cholesterol, and household food security were collected from participating adults before the intervention. Results indicated that this group has considerably worse health status than average US adults and also fares worse than average American Indians/Alaska Natives. To help improve these disparities, Native Americans need access to appropriate and effective means of health promotion.",2019,Results indicated that this group has considerably worse health status than average US adults and also fares worse than average American Indians/Alaska Natives.,"['176 adults from 96 families who participated', 'Adult Health Status', 'Native American Families Participating in the Growing Resilience Home Garden Study']",[],"['health status', 'body mass index, waist circumference, blood pressure, hemoglobin A1c, vitamin D, low-density lipoprotein cholesterol, and household food security']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}]",176.0,0.0210917,Results indicated that this group has considerably worse health status than average US adults and also fares worse than average American Indians/Alaska Natives.,"[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Porter', 'Affiliation': 'Division of Kinesiology and Health, University of Wyoming, Laramie, Wyoming.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Wechsler', 'Affiliation': 'Division of Kinesiology and Health, University of Wyoming, 1000 E. University Ave, Department 3196, Laramie, WY 82071. Email: alywex@uwyo.edu.'}, {'ForeName': 'Shawn J', 'Initials': 'SJ', 'LastName': 'Hime', 'Affiliation': 'Wyoming Survey & Analysis Center, University of Wyoming, Laramie, Wyoming.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naschold', 'Affiliation': 'Department of Economics, University of Wyoming, Laramie, Wyoming.'}]",Preventing chronic disease,['10.5888/pcd16.190021'] 732,30690866,Effects of sodium intake on postural lightheadedness: Results from the DASH-sodium trial.,"Lightheadedness after standing contributes to adverse clinical events, including falls. Recommendations for higher sodium intake to treat postural lightheadedness have not been evaluated in a trial setting. The Dietary Approaches to Stop Hypertension (DASH)-Sodium trial (1998-1999) tested the effects of the DASH diet and sodium reduction on blood pressure (BP). Participants were randomly assigned to DASH or a typical Western diet (control). During either diet, participants ate three sodium levels (50, 100, 150 meq/d at 2100 kcal) in random order for 30-days, separated by 5-day breaks. Participants reported the presence and severity of postural lightheadedness at baseline and after each feeding period. There were 412 participants (mean age 48 years; 57% women; 57% black). Mean baseline SBP/DBP was 135/86 mm Hg; 9.5% reported baseline lightheadedness. Among those consuming the DASH diet, high vs low sodium increased lightheadedness (OR 1.71; 95% CI: 1.01, 2.90; P = 0.047) and severity of lightheadedness (P = 0.02), but did not affect lightheadedness in those consuming the control diet (OR 0.77; 95% CI: 0.46, 1.29; P = 0.32). Among those consuming high vs low sodium in the context of the DASH diet, adults <60 vs ≥60 years old experienced more lightheadedness (P-interaction = 0.04), along with obese vs non-obese adults (P-interaction = 0.01). In the context of the DASH diet, higher sodium intake was associated with more frequent and severe lightheadedness. These findings challenge traditional recommendations to increase sodium intake to prevent lightheadedness.",2019,"Among those consuming the DASH diet, high vs low sodium increased lightheadedness (OR 1.71; 95% CI: 1.01, 2.90; P = 0.047) and severity of lightheadedness (P = 0.02), but did not affect lightheadedness in those consuming the control diet (OR 0.77; 95% CI: 0.46, 1.29; P = 0.32).",['412 participants (mean age 48\xa0years; 57% women; 57% black'],"['sodium intake', 'DASH or a typical Western diet (control', 'DASH diet and sodium reduction']","['postural lightheadedness', 'Mean baseline SBP/DBP', 'presence and severity of postural lightheadedness', 'lightheadedness', 'Lightheadedness', 'baseline lightheadedness', 'blood pressure (BP', 'severity of lightheadedness', 'frequent and severe lightheadedness']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C3849996', 'cui_str': 'Western Dietary Pattern'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0234987', 'cui_str': 'Dizziness on standing up (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220870', 'cui_str': 'Lightheadedness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0254527,"Among those consuming the DASH diet, high vs low sodium increased lightheadedness (OR 1.71; 95% CI: 1.01, 2.90; P = 0.047) and severity of lightheadedness (P = 0.02), but did not affect lightheadedness in those consuming the control diet (OR 0.77; 95% CI: 0.46, 1.29; P = 0.32).","[{'ForeName': 'Allison W', 'Initials': 'AW', 'LastName': 'Peng', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Tang', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13487'] 733,32122153,Active chest tube clearance after aortic valve surgery did not influence amount residual pericardial fluid after aortic valve replacement in a randomised trial.,"Objective. Evaluate if the use of active clearance of chest tubes after aortic valve surgery influenced bleeding and reduced postoperative residual pericardial effusion. Design. Prospective randomised trial comparing PleuraFlow ® 32 F chest tube with FlowGlide™ active clearance to a standard Argyle ® 32 F chest tube in 100 patients undergoing aortic valve surgery. Chest tube outputs and pericardial effusion measurements assessed by two-dimensional transthoracic echocardiography were recorded before hospital discharge. Results. Postoperative chest tube outputs per hour did not differ between the two groups. The median chest tube output was 400 mL for patients who had a PleuraFlow ® chest tube vs . 490 mL for patients with an Argyle ® chest tube ( p  = .08). Pericardial effusions ≥ 2 mm were detected in 76% vs. 68% of the patients ( p  = .50) and postoperative atrial fibrillation occurred in 42% vs . 34% ( p  = .54), respectively. Conclusions. Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.",2020,"Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.",['100 patients undergoing aortic valve surgery'],['PleuraFlow ® 32\u2009F chest tube with FlowGlide™ active clearance to a standard Argyle ® 32\u2009F chest tube'],"['Postoperative chest tube outputs per hour', 'postoperative atrial fibrillation', 'postoperative bleeding or degree of pericardial effusion', 'median chest tube output']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0349077', 'cui_str': 'Pericardial effusion - noninflammatory (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",100.0,0.0694004,"Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.","[{'ForeName': 'Linnéa', 'Initials': 'L', 'LastName': 'Malgerud', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Maret', 'Affiliation': 'Department of Clinical Physiology, Karolinska University Hospital, and Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reitan', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm and Department of Cardiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Ivert', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2020.1728373'] 734,31138568,"Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study of the Penetration of a Monoclonal Antibody Combination (ASN100) Targeting Staphylococcus aureus Cytotoxins in the Lung Epithelial Lining Fluid of Healthy Volunteers.","ASN100 is a novel antibody combination of two fully human IgG1(κ) monoclonal antibodies (MAbs), ASN-1 and ASN-2, which neutralize six Staphylococcus aureus cytotoxins, alpha-hemolysin (Hla) and five bicomponent leukocidins. We assessed the safety, tolerability, and serum and lung pharmacokinetics of ASN100 in a randomized, double-blind, placebo-controlled single-dose-escalation first-in-human study. Fifty-two healthy volunteers were enrolled and randomized to receive either ASN-1, ASN-2, a combination of both MAbs (ASN100), or a corresponding placebo. Thirty-two subjects in the double-blind dose escalation portion of the study received ASN-1 or ASN-2 at a 200-, 600-, 1,800-, or 4,000-mg dose, or placebo. Eight subjects received both MAbs simultaneously in a 1:1 ratio (ASN100) at 3,600 or 8,000 mg, or they received placebos. Twelve additional subjects received open-label ASN100 at 3,600 or 8,000 mg to assess the pharmacokinetics of ASN-1 and ASN-2 in epithelial lining fluid (ELF) by bronchoalveolar lavage fluid sampling. Subjects were monitored for 98 days (double-blind cohorts) or 30 days (open-label cohorts) for safety assessment. No dose-limiting toxicities were observed, and all adverse events were mild and transient, with only two adverse events considered possibly related to the investigational product. ASN100 exhibited linear serum pharmacokinetics with a half-life of approximately 3 weeks and showed detectable penetration into the ELF. No treatment-emergent anti-drug antibody responses were detected. The toxin neutralizing potency of ASN100 in human serum was confirmed up to 58 days postdosing. The favorable safety profile, ELF penetration, and maintained functional activity in serum supported the further clinical development of ASN100.",2019,ASN100 exhibited linear serum PK with a half-life of approximately three weeks and showed detectable penetration into the ELF.,"['Lung Epithelial Lining Fluid', 'Healthy Volunteers', 'Twelve additional subjects received', 'Fifty-two healthy volunteers']","['placebo', 'Monoclonal Antibody Combination (ASN100', 'Placebo', 'ASN100', 'ASN-1, ASN-2, or a combination of both mAbs (ASN100), or corresponding placebo', 'ASN-1 or ASN-2', 'placebos', 'open-label ASN100']","['No dose-limiting toxicities', 'safety, tolerability, and serum and lung pharmacokinetics of ASN100']","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.259477,ASN100 exhibited linear serum PK with a half-life of approximately three weeks and showed detectable penetration into the ELF.,"[{'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Magyarics', 'Affiliation': 'Arsanis Biosciences GmbH, Vienna, Austria Zoltan.Magyarics@x4pharma.com bernd.jilma@meduniwien.ac.at.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Leslie', 'Affiliation': 'Arsanis, Inc., Waltham, Massachusetts USA.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bartko', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Rouha', 'Affiliation': 'Arsanis Biosciences GmbH, Vienna, Austria.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Luperchio', 'Affiliation': 'Arsanis, Inc., Waltham, Massachusetts USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schörgenhofer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwameis', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Derhaschnig', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Lagler', 'Affiliation': 'Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Stiebellehner', 'Affiliation': 'Department of Internal Medicine II, Division of Pulmonology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Arsanis Biosciences GmbH, Vienna, Austria.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Campanaro', 'Affiliation': 'Arsanis, Inc., Waltham, Massachusetts USA.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria Zoltan.Magyarics@x4pharma.com bernd.jilma@meduniwien.ac.at.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Nagy', 'Affiliation': 'EveliQure Biotechnologies GmbH, Vienna, Austria.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stevens', 'Affiliation': 'Arsanis, Inc., Waltham, Massachusetts USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00350-19'] 735,32047014,Hospital-wide ELectronic medical record evaluated computerised decision support system to improve outcomes of Patients with staphylococcal bloodstream infection (HELP): study protocol for a multicentre stepped-wedge cluster randomised trial.,"INTRODUCTION Staphylococci are the most commonly identified pathogens in bloodstream infections. Identification of Staphylococcus aureus in blood culture (SAB) requires a prompt and adequate clinical management. The detection of coagulase-negative staphylococci (CoNS), however, corresponds to contamination in about 75% of the cases. Nevertheless, antibiotic therapy is often initiated, which contributes to the risk of drug-related side effects. We developed a computerised clinical decision support system (HELP-CDSS) that assists physicians with an appropriate management of patients with Staphylococcus bacteraemia. The CDSS is evaluated using data of the Data Integration Cent ers (DIC) established at each clinic. DICs transform heterogeneous primary clinical data into an interoperable format, and the HELP-CDSS displays information according to current best evidence in bacteraemia treatment. The overall aim of the HELP-CDSS is a safe but more efficient allocation of infectious diseases specialists and an improved adherence to established guidelines in the treatment of SAB. METHODS AND ANALYSIS The study is conducted at five German university hospitals and is designed as a stepped-wedge cluster randomised trial. Over the duration of 18 months, 135 wards will change from a control period to the intervention period in a randomised stepwise sequence. The coprimary outcomes are hospital mortality for all patients to establish safety, the 90-day disease reoccurrence-free survival for patients with SAB and the cumulative vancomycin use for patients with CoNS bacteraemia. We will use a closed, hierarchical testing procedure and generalised linear mixed modelling to test for non-inferiority of the CDSS regarding hospital mortality and 90-day disease reoccurrence-free survival and for superiority of the HELP-CDSS regarding cumulative vancomycin use. ETHICS AND DISSEMINATION The study is approved by the ethics committee of Jena University Hospital and will start at each centre after local approval. Results will be published in a peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION NUMBER DRKS00014320.",2020,We developed a computerised clinical decision support system (HELP-CDSS) that assists physicians with an appropriate management of patients with Staphylococcus bacteraemia.,"['patients with Staphylococcus bacteraemia', 'Patients with staphylococcal bloodstream infection (HELP', 'five German university hospitals']","['Hospital-wide ELectronic medical record evaluated computerised decision support system', 'computerised clinical decision support system (HELP-CDSS', 'HELP-CDSS']","['hospital mortality', '90-day disease reoccurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",135.0,0.144612,We developed a computerised clinical decision support system (HELP-CDSS) that assists physicians with an appropriate management of patients with Staphylococcus bacteraemia.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hagel', 'Affiliation': 'Institute for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gantner', 'Affiliation': 'Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Cord', 'Initials': 'C', 'LastName': 'Spreckelsen', 'Affiliation': 'Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Ammon', 'Affiliation': 'IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Kutaiba', 'Initials': 'K', 'LastName': 'Saleh', 'Affiliation': 'IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Lo An', 'Initials': 'LA', 'LastName': 'Phan-Vogtmann', 'Affiliation': 'Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Heidel', 'Affiliation': 'IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Helhorn', 'Affiliation': 'IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Kruse', 'Affiliation': 'IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rißner', 'Affiliation': 'Center for Clinical Studies, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Haferkamp', 'Affiliation': 'IT Department, Data Integration Center, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Vorwerk', 'Affiliation': 'IT Department, Data Integration Center, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Deffge', 'Affiliation': 'Department of Intensive and Intermediate Care, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Marc Fabian', 'Initials': 'MF', 'LastName': 'Juzek-Küpper', 'Affiliation': 'Medical Faculty, Division of Infection Control and Infectious Diseases, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lippmann', 'Affiliation': 'Institute of Medical Microbiology and Epidemiology on Infectious Diseases, University Hospital Leipzig, Leipzig, Sachsen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lübbert', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Division of Infectious Diseases and Tropical Medicine, University Hospital Leipzig, Leipzig, Sachsen, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Trawinski', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Division of Infectious Diseases and Tropical Medicine, University Hospital Leipzig, Leipzig, Sachsen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wendt', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Division of Infectious Diseases and Tropical Medicine, University Hospital Leipzig, Leipzig, Sachsen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wendt', 'Affiliation': 'IT Department, Data Integration Center, University Hospital Leipzig, Leipzig, Sachsen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Dürschmid', 'Affiliation': 'IT Department, Data Integration Center, University Hospital Leipzig, Leipzig, Sachsen, Germany.'}, {'ForeName': 'Margarethe', 'Initials': 'M', 'LastName': 'Konik', 'Affiliation': 'Department of Nephrology, Clinic for Infectiology, University of Duisburg-Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Section of Clinical Infectious Diseases, University Hospital Halle, Halle, Sachsen-Anhalt, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tiller', 'Affiliation': 'IT Department, Data Integration Center, University Hospital Halle, Halle, Sachsen-Anhalt, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Röhrig', 'Affiliation': 'Institute of Medical Informatics, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Schulte-Coerne', 'Affiliation': 'Department of Informatics, Technical University of Munich, Munchen, Bayern, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Fortmann', 'Affiliation': 'Institute of Medical Informatics, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jonas', 'Affiliation': 'Department of Informatics, Technical University of Munich, Munchen, Bayern, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Institute for Infectious Diseases, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Peter-Michael', 'Initials': 'PM', 'LastName': 'Rath', 'Affiliation': 'Institute for Medical Microbiology, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Mathias W', 'Initials': 'MW', 'LastName': 'Pletz', 'Affiliation': 'Institute for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Scherag', 'Affiliation': 'Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany andre.scherag@med.uni-jena.de.'}]",BMJ open,['10.1136/bmjopen-2019-033391'] 736,32047015,"Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial.","INTRODUCTION Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomised controlled trials (RCTs) are lacking but are clearly required. METHODS AND ANALYSIS TJDBPS01 is a multicentre, prospective, randomised controlled, parallel-group, superiority trial in 14 centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay. ETHICS AND DISSEMINATION The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organisation. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER NCT03138213.",2020,Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated.,"['14 centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs', '656 patients who will undergo PD']","['Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01', 'TLPD group or OPD', 'Pancreatoduodenectomy (PD', 'TLPD', 'total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD']",['postoperative length of stay'],"[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",656.0,0.24767,Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated.,"[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Yechen', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Junfang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Rufu', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xuemin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pancreaticobiliary Surgery, Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China.'}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': ""Department of Hepatobiliary Surgery, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': ""Department of Hepatobiliary Surgery, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Dewei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, Chongqing Medical University First Affiliated Hospital, Chongqing, Sichuan, China.'}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatico-Hepatobiliary Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Pancreatico-Hepatobiliary Surgery, The Second Affiliated Hospital, Army Medical University, Chongqing, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatico-Hepatobiliary Surgery, The Second Affiliated Hospital, Army Medical University, Chongqing, Chongqing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Hepato-Pancreato-Biliary Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Hepato-Pancreato-Biliary Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Yahui', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Jilin University First Hospital, Changchun, Jilin, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wenxing', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Hepato-Pancreato-Biliary Surgery, Xuzhou Medical College Affiliated Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Heguang', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Hepato-Pancreato-Biliary Surgery, Fujian Medical University Union Hospital, Xiamen, Fujian, China.'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Hepatobiliary Pancreatic Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Renyi', 'Initials': 'R', 'LastName': 'Qin', 'Affiliation': 'Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China ryqin@tjh.tjmu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-033490'] 737,32051297,Cost-effectiveness analysis of cetuximab combined with chemotherapy as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer based on the TAILOR trial.,"OBJECTIVES Cetuximab plus leucovorin, fluorouracil and oxaliplatin (FOLFOX-4) is superior to FOLFOX-4 alone as a first-line treatment for patients with metastatic colorectal cancer with RAS wild-type (RAS wt mCRC), with significantly improved survival benefit by TAILOR, an open-label, randomised, multicentre, phase III trial. Nevertheless, the cost-effectiveness of these two regimens remains uncertain. The following study aims to determine whether cetuximab combined with FOLFOX-4 is a cost-effective regimen for patients with specific RAS wt mCRC in China. DESIGN A cost-effectiveness model combined decision tree and Markov model was built to simulate pateints with RAS wt mCRC based on health states of dead, progressive and stable. The health outcomes from the TAILOR trial and utilities from published data were used respectively. Costs were calculated with reference to the Chinese societal perspective. The robustness of the results was evaluated by univariate and probabilistic sensitivity analyses. PARTICIPANTS The included patients were newly diagnosed Chinese patients with fully RAS wt mCRC. INTERVENTIONS First-line treatment with either cetuximab plus FOLFOX-4 or FOLFOX-4. MAIN OUTCOME MEASURES The primary outcomes are costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). RESULTS Baseline analysis disclosed that the QALYs was increased by 0.383 caused by additional cetuximab, while an increase of US$62 947 was observed in relation to FOLFOX-4 chemotherapy. The ICER was US$164 044 per QALY, which exceeded the willingness-to-pay threshold of US$28 106 per QALY. CONCLUSIONS Despite the survival benefit, cetuximab combined with FOLFOX-4 is not a cost-effective treatment for the first-line regime of patients with RAS wt mCRC in China. TRIAL REGISTRATION NUMBER TAILOR trial (NCT01228734); Post-results.",2020,"Despite the survival benefit, cetuximab combined with FOLFOX-4 is not a cost-effective treatment for the first-line regime of patients with RAS wt mCRC in China. ","['The included patients were newly diagnosed Chinese patients with fully RAS wt mCRC', 'patients with RAS wild-type metastatic colorectal cancer based on the TAILOR trial', 'patients with metastatic colorectal cancer with RAS wild-type (RAS wt mCRC', 'patients with specific RAS wt mCRC in China', 'patients with RAS wt mCRC in China']","['cetuximab combined with FOLFOX-4', 'cetuximab plus FOLFOX-4 or FOLFOX-4', 'cetuximab combined with chemotherapy', 'Cetuximab plus leucovorin, fluorouracil and oxaliplatin (FOLFOX-4']","['QALYs', 'costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs', 'survival benefit']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0411793,"Despite the survival benefit, cetuximab combined with FOLFOX-4 is not a cost-effective treatment for the first-line regime of patients with RAS wt mCRC in China. ","[{'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Lingfei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Zhengyi', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': ""Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Department of Pharmacy, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Luo', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ""Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China fangluo@zju.edu.cn.""}]",BMJ open,['10.1136/bmjopen-2019-030738'] 738,32051303,A double-blind randomised placebo-controlled trial of melatonin as an adjuvant agent in induction of labour (MILO): a study protocol.,"INTRODUCTION Induction of labour (IOL) is a common practice. In Australia, up to 40% of women undergoing labour induction will ultimately have a caesarean section. As a biological role for melatonin in the onset and progress of labour has been demonstrated, we aim to test the hypothesis that addition of melatonin will reduce the need for caesarean section. METHODS AND ANALYSIS This is a double-blind, randomised, placebo-controlled trial in women undergoing IOL at term. We plan to randomise 722 women (1:1 ratio) to receive either melatonin (four doses of 10 mg melatonin: first dose-in the evening at the time of cervical balloon or Dinoprostone PGE 2 vaginal pessary insertion, second dose-at time of oxytocin infusion commencement, third dose-6 hours after the second dose, fourth dose-6 hours after the third dose) or placebo (same dosing regime). Participants who are having artificial rupture of the membranes only as the primary means of labour induction will receive up to three doses of the trial intervention. The primary outcome measure will be the requirement for a caesarean section. Secondary outcomes will include duration of each stage of labour and time from induction to birth, total dose of oxytocin administration, epidural rate, indication for caesarean section, rate of instrumental deliveries, birth within 24 hours of induction commencement, estimated blood loss, Apgar score at 5 min, neonatal intensive care unit admissions and participant satisfaction. Maternal melatonin levels will be measured immediately before commencement of the oxytocin intravenous infusion and 3 hours after and at the time of birth in order to determine any differences between the two trial arms. ETHICS AND DISSEMINATION The study is conducted in accordance with the conditions of Monash Health HREC (RES-17-0000-168A). Findings from the trial will be disseminated through peer-reviewed publications and conference presentations. PROTOCOL VERSION V.7.0, 30 July 2019. TRIAL REGISTRATION NUMBER ACTRN12616000311459, Universal trial number: (UTN) U1111-1195-3515.",2020,Participants who are having artificial rupture of the membranes only as the primary means of labour induction will receive up to three doses of the trial intervention.,"['VERSION\n\n\nV.7.0, 30 July 2019', '722 women (1:1 ratio', 'women undergoing IOL at term', 'Participants who are having artificial rupture of the membranes only as the primary means of labour induction']","['placebo', 'melatonin', 'Dinoprostone PGE']","['Maternal melatonin levels', 'duration of each stage of labour and time from induction to birth, total dose of oxytocin administration, epidural rate, indication for caesarean section, rate of instrumental deliveries, birth within 24\u2009hours of induction commencement, estimated blood loss, Apgar score at 5\u2009min, neonatal intensive care unit admissions and participant satisfaction', 'requirement for a caesarean section']","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery (procedure)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.723251,Participants who are having artificial rupture of the membranes only as the primary means of labour induction will receive up to three doses of the trial intervention.,"[{'ForeName': 'Kamala', 'Initials': 'K', 'LastName': 'Swarnamani', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Davies-Tuck', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia Miranda.davies@hudson.org.au.'}, {'ForeName': 'Euan', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mockler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032480'] 739,31999300,Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy.,"Importance Preservation of peripheral visual field (VF) is considered an advantage for anti-vascular endothelial growth factor agents compared with panretinal photocoagulation (PRP) for treatment of proliferative diabetic retinopathy. Long-term data on VF are important when considering either treatment approach. Objective To further evaluate changes in VF throughout 5 years among eyes enrolled in the Protocol S clinical trial, conducted by the DRCR Retina Network. Design, Setting, and Participants Post hoc analyses of an ancillary study within a multicenter (55 US sites) randomized clinical trial. Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included. Data were collected from February 2012 to February 2018. Analysis began in June 2018. Interventions Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab. Diabetic macular edema, whenever present, was treated with ranibizumab in both groups. Panretinal photocoagulation could be administered to eyes in the ranibizumab group when failure or futility criteria were met. Main Outcomes and Measures Mean change in total point score on VF testing with the Humphrey Field Analyzer 30-2 and 60-4 test patterns. Results Of 394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study. Of these, 167 (71.4%) had VF meeting acceptable quality criteria at baseline (median [interquartile range] age, 50 [43-58] years; 90 men [53.9%]). At 5 years, 79 (33.8%) had results available. The mean (SD) change in total point score in the PRP and ranibizumab groups was -305 (521) dB and -36 (486) dB at 1 year, respectively, increasing to -527 (635) dB and -330 (645) dB at 5 years, respectively (P = .04). After censoring VF results after PRP treatments in the ranibizumab group, the 5-year mean change in total point score was -201 (442) dB. In a longitudinal regression analysis of change in total point score including both treatment groups, laser treatment was associated with a mean point decrease of 208 (95% CI, 112-304) dB for the initial PRP session, 77 (95% CI, 21-132) dB for additional PRP sessions, and 325 (95% CI, 211-439) dB for endolaser. No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]). Conclusions and Relevance The limited data available from Protocol S suggest that there are factors besides PRP associated with VF loss in eyes treated for proliferative diabetic retinopathy. Further clinical research is warranted to clarify the finding. Trial Registration ClinicalTrials.gov identifier: NCT01489189.",2020,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]). ","['Proliferative Diabetic Retinopathy', '394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study', 'Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included', 'Data were collected from February 2012 to February 2018']","['Panretinal photocoagulation', 'panretinal photocoagulation (PRP', 'Panretinal Photocoagulation or Ranibizumab', 'Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab', 'ranibizumab', 'peripheral visual field (VF']","['total point score', 'mean (SD) change in total point score', 'Visual Field Changes', 'Main Outcomes and Measures\n\n\nMean change in total point score on VF testing', '5-year mean change in total point score', 'Diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]",,0.0737913,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]). ","[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Johnson', 'Affiliation': 'Visual Field Reading Center, University of Iowa, Iowa City.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Pieramici', 'Affiliation': 'California Retina Consultants, Santa Barbara.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5939'] 740,30425326,Benefits of mindfulness meditation in reducing blood pressure and stress in patients with arterial hypertension.,"The objective of this randomized controlled trial is to evaluate the benefits of mindfulness meditation in controlling ambulatory blood pressure (BP) and the impact of the intervention on anxiety, stress and depression levels in a Mediterranean population. Twenty-four and 18 patients [n = 42; mean age 56.5 (7.7) years; similar men and women proportions] with high-normal BP or grade I hypertension were enrolled to an intervention and a control group, respectively. For 2 h/week over 8 weeks, the intervention group received mindfulness training and the control group attended health education talks. The patients attended pre-intervention, week 4, week 8 and week 20 follow-up visits. 61.9% of the patients had anxiety, 21.4% depression, 19.0% were smokers and 14.2% were diabetic (no significant differences between the 2 groups). At baseline, the intervention group had non-significant higher clinically measured BP values, whereas both groups had similar ambulatory BP monitoring (ABPM) values. At week 8, the intervention group had statistically significant lower ABPM scores than the control group (124/77 mmHg vs 126/80 mmHg (p < 0.05) and 108/65 mmHg vs 114/69 mmHg (p < 0.05) for 24-h and night-time systolic BP (SBP), respectively) and also had lower clinically measured SBP values (130 mmHg vs 133 mmHg; p = 0.02). At week 20 (follow-up), means were lower in the intervention group (although not statistically significant). Improvements were observed in the intervention group in terms of being less judgemental, more accepting and less depressed. In conclusion, by week 8 the mindfulness group had lower clinically measured SBP, 24-h SBP, at-rest SBP and diastolic BP values.",2019,"At week 8, the intervention group had statistically significant lower ABPM scores than the control group (124/77 ","['I hypertension', 'Twenty-four and 18 patients [n\u2009=\u200942; mean age 56.5 (7.7) years; similar men and women proportions] with high-normal BP or grade', 'a Mediterranean population', 'patients with arterial hypertension']","['mindfulness training and the control group attended health education talks', 'mindfulness meditation']","['anxiety, stress and depression levels', 'SBP values', 'ambulatory BP monitoring (ABPM) values', 'SBP, 24-h SBP, at-rest SBP and diastolic BP values', 'ABPM scores', 'diabetic', 'ambulatory blood pressure (BP', '24-h and night-time systolic BP (SBP', 'BP values', 'blood pressure and stress']","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018701'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0150277'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.0350722,"At week 8, the intervention group had statistically significant lower ABPM scores than the control group (124/77 ","[{'ForeName': 'Paola Helena', 'Initials': 'PH', 'LastName': 'Ponte Márquez', 'Affiliation': 'Hospital Santa Creu i Sant Pau, Internal Medicine Service, Hypertension and Cardiovascular Risk Unit, Barcelona, Spain. paola_ponte@yahoo.com.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Institut de Recerca, Parc Sanitari Sant Joan de Deu, Teaching, Research and Innovation Unit Sant Boi de Llobregat, Llobregat, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Solé-Villa', 'Affiliation': 'Hospital Santa Creu i Sant Pau, Internal Medicine Service, Hypertension and Cardiovascular Risk Unit, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Matas-Pericas', 'Affiliation': 'Hospital Santa Creu i Sant Pau, Internal Medicine Service, Hypertension and Cardiovascular Risk Unit, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Filella-Agullo', 'Affiliation': 'Hospital Santa Creu i Sant Pau, Internal Medicine Service, Hypertension and Cardiovascular Risk Unit, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Ruiz-Herrerias', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Occupational Health Service, Barcelona, Spain.'}, {'ForeName': 'Joaquím', 'Initials': 'J', 'LastName': 'Soler-Ribaudi', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Psychiatry Service, Barcelona, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Roca-Cusachs Coll', 'Affiliation': 'Universitat Autònoma de Barcelona, School of Medicine, Bellaterra, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Arroyo-Díaz', 'Affiliation': 'Hospital Santa Creu i Sant Pau, Internal Medicine Service, Hypertension and Cardiovascular Risk Unit, Barcelona, Spain.'}]",Journal of human hypertension,['10.1038/s41371-018-0130-6'] 741,32041861,Protocol for a feasibility study: a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating.,"INTRODUCTION Adolescents with type 1 diabetes are at a higher risk of developing psychiatric disorders, particularly eating disorders, compared with their healthy peers. In turn, this increases the risk for sub-optimal glycaemic control and life-threatening diabetes-related complications. Despite these increased risks, standard diabetes care does not routinely provide psychological support to help prevent or reduce mental health risks. There is an urgent need to develop 'clinically usable' psychosocial interventions that are acceptable to patients and can be realistically integrated into clinical care. This study aims to examine the feasibility and acceptability of a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating behaviour. METHODS AND ANALYSIS This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group. Participants aged 12-16 years will be recruited from three diabetes outpatient clinics in Auckland, New Zealand. The brief self-compassion intervention is adapted from the standardised 'Making Friends with Yourself' intervention and will be delivered in a group format over two sessions. Apart from examining feasibility and acceptability through the flow of participants through the study and qualitative questions, we will assess changes to disordered eating behaviour (primary outcome), self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control (secondary outcomes). Such data will be used to calculate the required sample size for a fully powered randomised controlled trial. ETHICS AND DISSEMINATION This trial has received ethics approval from the Health and Disability Ethics Committee (research project number A+8467). Study results will be disseminated through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER ANZCTR (12619000541101).",2020,"This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group.","['adolescents with type 1 diabetes and disordered eating', 'Participants aged 12-16 years will be recruited from three diabetes outpatient clinics in Auckland, New Zealand', 'Adolescents with type 1 diabetes', 'adolescents with type 1 diabetes and disordered eating behaviour']","['brief self-compassion intervention', 'self-compassion intervention']","['feasibility and acceptability', 'disordered eating behaviour (primary outcome), self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control (secondary outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.112588,"This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group.","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Boggiss', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand abog579@aucklanduni.ac.nz.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Consedine', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Jefferies', 'Affiliation': ""Starship Children's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bluth', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2019-034452'] 742,31924544,Phase 1 Study of OPT-302 Inhibition of Vascular Endothelial Growth Factors C and D for Neovascular Age-Related Macular Degeneration.,"PURPOSE OPT-302 is a novel inhibitor of vascular endothelial growth factor (VEGF)-C and VEGF-D. A phase 1 trial assessed the safety of intravitreal OPT-302 as monotherapy or combined with ranibizumab (Lucentis; Genentech, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD). DESIGN Open-label, dose escalation followed by a randomized dose expansion. PARTICIPANTS Fifty-one patients with nAMD who were either treatment naïve (n = 25) or previously were treated with anti-VEGF A therapy (n = 26). METHODS In the dose escalation, groups of 5 patients in 4 cohorts received ascending doses of OPT-302 (0.3 mg, 1 mg, or 2 mg) in combination with ranibizumab (0.5 mg), or as monotherapy (2 mg). In the dose expansion, 31 patients were randomized (3:1) to OPT-302 (2 mg) in combination with ranibizumab (n = 23) or as monotherapy (n = 8). Participants received three intravitreal treatments of OPT-302 once every 4 weeks either with or without ranibizumab. MAIN OUTCOME MEASURES Safety and tolerability, OPT-302 pharmacokinetics and immunogenicity, effects on best-corrected visual acuity (BCVA), and anatomic changes. RESULTS Intravitreal OPT-302 with or without ranibizumab was well tolerated with low systemic exposure, no dose-limiting toxicities and no immunogenicity. In patients receiving OPT-302 monotherapy, 7 of 13 (54%) did not require rescue anti-VEGF-A therapy and the mean change in BCVA from baseline to week 12 was +5.6 letters (range, 0-18 letters). Mean BCVA gains from baseline to week 12 following combination OPT-302 with ranibizumab were +10.8 letters (95% confidence interval [CI], 4-17; n = 18) in treatment-naïve patients and +4.9 letters (95% CI, 3-7; n = 19) in previously treated patients, respectively. Corresponding reductions in mean central subfield thickness at week 12 in both groups were -119 μm (95% CI, -176 to -62 μm) and -54 μm (95% CI, -82 to -26 μm), respectively, whilst 50% of treatment-naïve patients also showed no detectable choroidal neovascularization at week 12 on fluorescein angiography. CONCLUSIONS Intravitreal OPT-302 inhibition of VEGF-C and -D was well tolerated, and OPT-302 combination therapy may overcome an escape mechanism to VEGF-A suppression in the management of nAMD.",2020,"Corresponding reductions in mean central subfield thickness at week 12 in both groups were -119 μm (95% CI, -176 to -62 μm) and -54 μm (95% CI, -82 to -26 μm), respectively, whilst 50% of treatment-naïve patients also showed no detectable choroidal neovascularization at week 12 on fluorescein angiography. ","['Fifty-one patients with nAMD who were either treatment naïve (n\xa0= 25) or previously were treated with', 'n\xa0= 26', 'Neovascular Age-Related Macular Degeneration', 'patients with neovascular age-related macular degeneration (nAMD']","['intravitreal OPT-302', 'ranibizumab (Lucentis; Genentech, South San Francisco, CA', 'OPT-302 (2 mg) in combination with ranibizumab', 'OPT-302', 'OPT-302 Inhibition of Vascular Endothelial Growth Factors C and D', 'ranibizumab', 'monotherapy', 'anti-VEGF A therapy']","['choroidal neovascularization', 'mean central subfield thickness', 'Safety and tolerability, OPT-302 pharmacokinetics and immunogenicity, effects on best-corrected visual acuity (BCVA), and anatomic changes', 'Mean BCVA gains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0388911', 'cui_str': 'Vascular Endothelial Growth Factor C'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",51.0,0.101285,"Corresponding reductions in mean central subfield thickness at week 12 in both groups were -119 μm (95% CI, -176 to -62 μm) and -54 μm (95% CI, -82 to -26 μm), respectively, whilst 50% of treatment-naïve patients also showed no detectable choroidal neovascularization at week 12 on fluorescein angiography. ","[{'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retina-Vitreous Associates Medical Group, Beverly Hills, California.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye Ear Nose & Throat Associates, Charlotte, North Carolina.'}, {'ForeName': 'Nathan C', 'Initials': 'NC', 'LastName': 'Steinle', 'Affiliation': 'California Retina Consultants, Santa Barbara, California.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Varenhorst', 'Affiliation': 'Vitreo-Retinal Consultants and Surgeons, Wichita, Kansas.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Pearlman', 'Affiliation': 'Retinal Consultants Medical Group, Sacramento, California.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Gillies', 'Affiliation': 'Save Sight Institute, Sydney University, Sydney, Australia.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Finger', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Baldwin', 'Affiliation': 'Opthea, Ltd, South Yarra, Australia.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Leitch', 'Affiliation': 'Opthea, Ltd, South Yarra, Australia. Electronic address: ian.leitch@opthea.com.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.10.008'] 743,31734069,Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial.,"BACKGROUND Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy. METHODS We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1-5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239. FINDINGS Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital. INTERPRETATION Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results. FUNDING US National Institutes of Health.",2020,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","['Between Aug 2, 2017, and Jan 15, 2019', '750 participants', 'recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy', 'patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs']","['Thermal ablation versus cryotherapy or loop excision', 'thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation', 'routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA', 'LLETZ']","['treatment success, defined as either human papillomavirus (HPV) type-specific clearance', 'severe pain', 'complication requiring medical consultation or admission to hospital', 'Treatment success']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",750.0,0.164652,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","[{'ForeName': 'Leeya F', 'Initials': 'LF', 'LastName': 'Pinder', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA; Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Groesbeck P', 'Initials': 'GP', 'LastName': 'Parham', 'Affiliation': 'Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia; Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France. Electronic address: basup@iarc.fr.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Muwonge', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Namakau', 'Initials': 'N', 'LastName': 'Nyambe', 'Affiliation': 'UNC Global Project-Zambia, Lusaka, Zambia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sauvaget', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Mulindi H', 'Initials': 'MH', 'LastName': 'Mwanahamuntu', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Newborn Hospital, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Rengaswamy', 'Initials': 'R', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Research Triangle Institute, International-India, Commercial Tower, Pullman Hotel Aerocity, New Delhi, India.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Prendiville', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30635-7'] 744,32057131,Imaginator: A Proof-of-Concept Feasibility Trial of a Brief Imagery-Based Psychological Intervention for Young People Who Self-Harm.,"OBJECTIVES The Imaginator study tested the feasibility of a short mental imagery-based psychological intervention for young people who self-harm and used a stepped-wedge design to investigate effects on self-harm frequency reduction at 3 and 6 months. METHOD A total of 38 participants aged 16-25 were recruited via community self-referral and mental health services. Participants were randomized to immediate delivery of Functional Imagery Training (FIT) or usual care followed by delayed delivery after 3 months. FIT comprised two face-to-face sessions, five phone sessions, and use of a smartphone app. Outcomes' assessment was blind to allocation. RESULTS Three quarters of those who began treatment completed face-to-face sessions, and 57% completed five or more sessions in total. Self-harm frequency data were obtained on 76% of the sample at 3 months (primary outcome) and 63% at 6 months. FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75). The Immediate FIT group maintained improvements from 3 to 6 months (d = 0.05). Participants receiving usual care also reduced self-harm (d = 0.47). CONCLUSIONS A brief mental imagery-based psychological intervention targeting self-harm in young people is feasible and may comprise a novel transdiagnostic treatment for self-harm.",2020,FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75).,"['young people', 'Young People', 'Participants receiving usual care also reduced self-harm (d\xa0=\xa00.47', '38 participants aged 16-25 were recruited via community self-referral and mental health services', 'Imaginator', 'young people who self-harm']","['mental imagery-based psychological intervention', 'Brief Imagery-Based Psychological Intervention', 'short mental imagery-based psychological intervention', 'Functional Imagery Training (FIT) or usual care followed by delayed delivery after 3\xa0months']",[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0237824', 'cui_str': 'Self-referral (procedure)'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0235863', 'cui_str': 'Delayed delivery'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],38.0,0.0348264,FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75).,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Di Simplicio', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Appiah-Kusi', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Meiser-Stedman', 'Affiliation': 'Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': ""Centre for Children's Health Research, School of Psychology & Counselling, Institute of Health & Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12620'] 745,32147276,The Effects of a Continuous Olfactory Stimulation Using Breast Milk (COSB) on Behavioral State and Physiological Responses in Korean Premature Infants.,"PURPOSE This study aimed to evaluate the effects of continuous olfactory stimulation with breast milk (COSB) on behavioral and physiologic states of Korean premature infants. DESIGN AND METHODS We examined the COSB effects on the behavioral states and physiological responses, including heart rate and oxygen saturation, in 30 premature infants using a non-equivalent control group pre- and post-test design. Sterile 2 cm × 2 cm gauzes wet with 2 cc breast milk were placed 10 cm away from the infants' nostrils 8 times per day for 3 consecutive days. We obtained five measurements each of the behavioral state, heart rate, and oxygen saturation of the premature infants in the neonatal intensive care unit (NICU). Statistical analysis was conducted using descriptive statistics and two-way repeated-measures ANOVA. RESULTS The experiment group presented significantly reduced heart rate variations (p = .039). There were significant differences in the heart rate at all time-points in the control group (p < .001) but not in the experimental group, indicating more stable (p > .089) heart rates in the latter group. There were positive COSB effects on the behavioral states of premature infants at some time points. CONCLUSIONS COSB can be a useful intervention program for high-risk infants for partial behavioral state stabilization and significant heart rate stabilization. PRACTICE IMPLICATIONS COSB might enable NICU nurses to provide a useful and safe developmental care plan for the premature infants hospitalized in the NICU to improve their physiologic and behavioral condition.",2020,"There were significant differences in the heart rate at all time-points in the control group (p < .001) but not in the experimental group, indicating more stable (p > .089)","['30 premature infants using a non-equivalent control group pre- and post-test design', 'premature infants in the neonatal intensive care unit (NICU', 'Korean premature infants']","['Sterile 2\xa0cm', 'continuous olfactory stimulation using breast milk (COSB', 'continuous olfactory stimulation with breast milk (COSB']","['behavioral state and physiological responses', 'heart rate variations', 'heart rate and oxygen saturation', 'heart rate', 'heart rates', 'positive COSB effects', 'behavioral state, heart rate, and oxygen saturation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}]","[{'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",30.0,0.02406,"There were significant differences in the heart rate at all time-points in the control group (p < .001) but not in the experimental group, indicating more stable (p > .089)","[{'ForeName': 'Young Ah', 'Initials': 'YA', 'LastName': 'Park', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ypark2016@khu.ac.kr.'}, {'ForeName': 'Yeo Jin', 'Initials': 'YJ', 'LastName': 'Im', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul, Republic of Korea. Electronic address: imyj@khu.ac.kr.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.02.042'] 746,32147306,The impact of Community intervention on the time from Symptom onset to first medical contact with acute coronary syndrome.,"OBJECTIVE Patient delay in the recognition of and response to the symptoms of acute coronary syndrome (ACS) is a worldwide problem. A community education program about chest pain was implemented in China, and was aimed at providing better community intervention. In this study, the impact of this program on the time of symptom onset to the first medical contact (SO-to-FMC) in ACS patients was investigated, as was the incidence of major adverse cardiac and cerebrovascular events (MACCE) in these patients. METHODS A total of 10 local communities were included in this study. A 9-month intensive community education program about chest pain was conducted in these communities. The data on the demographics, mode of transportation, procedures, clinical outcomes, and discharge diagnoses of all ACS patients in these communities were collected. RESULTS The study communities had a combined population of 361,609, and all community population sizes ranged from 12,823 to 66,127. The average SO-to-FMC time of the control period was 510 min, whereas, following community intervention, the average SO-to-FMC time was 256 min (P <  0.001). Furthermore, comparative analyses revealed that, following discharge from the hospital, the 1.5-year MACCE-free survival rate was higher in the community intervention group than in the control group (95.0 % vs. 90.5 %, P =  0.025), and the 1.5-year mortality rate was lower in the community intervention group than in the control group (3.3 % vs. 6.3 %, P =  0.03). CONCLUSIONS AND PRACTICAL IMPLICATIONS The Hangzhou Chest Pain Science Education Project(HCPSEP) was found to reduce the SO-to-FMC time and improve the outcome of ACS patients. This indicates that a scientific, educational program on chest pain can be effective in improving the knowledge and alertness of the local residents about chest pain. This type of program may be recognized and carried out in other regions.",2020,"This indicates that a scientific, educational program on chest pain can be effective in improving the knowledge and alertness of the local residents about chest pain.","['A total of 10 local communities', 'acute coronary syndrome', 'study communities had a combined population of 361,609, and all community population sizes ranged from 12,823 to 66,127']","['intensive community education program', 'Community intervention']","['1.5-year MACCE-free survival rate', 'average SO-to-FMC time', 'incidence of major adverse cardiac and cerebrovascular events (MACCE', '1.5-year mortality rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032683', 'cui_str': 'Population Size'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0009470', 'cui_str': 'Community Health Education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0194084,"This indicates that a scientific, educational program on chest pain can be effective in improving the knowledge and alertness of the local residents about chest pain.","[{'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Yong-Ran', 'Initials': 'YR', 'LastName': 'Cheng', 'Affiliation': 'Zhejiang Academy of Medical Sciences, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Gan', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Aliaweisali', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Min-Juan', 'Initials': 'MJ', 'LastName': 'Wu', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Kai-Han', 'Initials': 'KH', 'LastName': 'Ren', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Jun-Zhe', 'Initials': 'JZ', 'LastName': 'Bao', 'Affiliation': 'Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Zhan-Hui', 'Initials': 'ZH', 'LastName': 'Feng', 'Affiliation': 'Affiliated Hospital of Guizhou Medical University, Department of Neurology, Guiyang, China. Electronic address: h9450203@126.com.'}, {'ForeName': 'Xing-Wei', 'Initials': 'XW', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China. Electronic address: hsdzxw@126.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.041'] 747,32060156,"Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial.","INTRODUCTION In the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS. METHODS AND ANALYSIS In this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m 2 plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting. ETHICS AND DISSEMINATION The Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent's University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER ClinicalTrials.gov-Identifier: NCT03036800.European Clinical Trials Database-Identifier: EudraCT Number 2017-002998-20.",2020,"Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting. ","['384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m 2 plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea']","['Liraglutide', 'standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules']","['weight loss', 'comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2955667', 'cui_str': 'Does budget (finding)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",384.0,0.151608,"Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting. ","[{'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Papamargaritis', 'Affiliation': 'Diabetes Research Centre, Leicester General Hospital, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Obesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Crane', 'Affiliation': ""Institute of Diabetes, Endocrinology and Obesity (IDEO), Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Carel', 'Initials': 'C', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McGowan', 'Affiliation': ""Institute of Diabetes, Endocrinology and Obesity (IDEO), Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': ""O'Shea"", 'Affiliation': ""Department of Endocrinology and Diabetes Mellitus, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, Leicester General Hospital, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Clinical Research Group, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, Leicester General Hospital, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK melanie.davies@uhl-tr.nhs.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034137'] 748,32066598,Randomised controlled trial to investigate the relationship between mild hypercapnia and cerebral oxygen saturation in patients undergoing major surgery.,"OBJECTIVES The effects of hypercapnia on regional cerebral oxygen saturation (rSO 2 ) during surgery are unclear. We conducted a randomised controlled trial to investigate the relationship between mild hypercapnia and rSO 2 . We hypothesised that, compared with targeted normocapnia (TN), targeted mild hypercapnia (TMH) during major surgery would increase rSO 2 . DESIGN A prospective, randomised, controlled trial in adult participants undergoing elective major surgery. SETTING A single tertiary centre in Heidelberg, Victoria, Australia. PARTICIPANTS 40 participants were randomised to either a TMH or TN group (20 to each). INTERVENTIONS TMH (partial pressure of carbon dioxide in arterial blood, PaCO 2 , 45-55 mm Hg) or TN (PaCO 2 35-40 mm Hg) was delivered via controlled ventilation throughout surgery. PRIMARY AND SECONDARY OUTCOME MEASURES The primary endpoint was the absolute difference between the two groups in percentage change in rSO 2 from baseline to completion of surgery. Secondary endpoints included intraoperative pH, bicarbonate concentration, base excess, serum potassium concentration, incidence of postoperative delirium and length of stay (LOS) in hospital. RESULTS The absolute difference between the two groups in percentage change in rSO 2 from the baseline to the completion of surgery was 19.0% higher in both hemispheres with TMH (p<0.001). On both sides, the percentage change in rSO 2 was greater in the TMH group than the TN group throughout the duration of surgery. The difference between the groups became more noticeable over time. Furthermore, postoperative delirium was higher in the TN group (risk difference 0.3, 95% CI 0.1 to 0.5, p=0.02). LOS was similar between groups (5 days vs 5 days; p=0.99). CONCLUSION TMH was associated with a stable increase in rSO 2 from the baseline, while TN was associated with a decrease in rSO 2 in both hemispheres in patients undergoing major surgery. This resulted in a clear separation of percentage change in rSO 2 from the baseline between TMH and TN over time. Our findings provide the rationale for larger studies on TMH during surgery. TRIAL REGISTRATION NUMBER The Australian New Zealand Clinical Trials Registry (ACTRN12616000320459).",2020,"Furthermore, postoperative delirium was higher in the TN group (risk difference 0.3, 95% CI 0.1 to 0.5, p=0.02).","['A single tertiary centre in Heidelberg, Victoria, Australia', 'patients undergoing major surgery', 'adult participants undergoing elective major surgery', '40 participants']","['TMH', 'hypercapnia', 'TMH (partial pressure of carbon dioxide in arterial blood, PaCO 2 , 45-55\u2009mm Hg) or TN (PaCO 2 35-40\u2009mm Hg) was delivered via controlled ventilation throughout surgery', 'TMH or TN']","['LOS', 'regional cerebral oxygen saturation', 'mild hypercapnia and cerebral oxygen saturation', 'intraoperative pH, bicarbonate concentration, base excess, serum potassium concentration, incidence of postoperative delirium and length of stay (LOS) in hospital', 'postoperative delirium']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood (substance)'}, {'cui': 'C0450402', 'cui_str': '40mm (qualifier value)'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201985', 'cui_str': 'Base excess - observation'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",40.0,0.425041,"Furthermore, postoperative delirium was higher in the TN group (risk difference 0.3, 95% CI 0.1 to 0.5, p=0.02).","[{'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'The Department of Medicine, Austin Health, The Univesity of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Cowie', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Chong Oon', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tremewen', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Pearce', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Param', 'Initials': 'P', 'LastName': 'Pillai', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Dharshi', 'Initials': 'D', 'LastName': 'Karalapillai', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia laurence.weinberg@austin.org.au.'}]",BMJ open,['10.1136/bmjopen-2019-029159'] 749,32102813,"MinT-trial: Mindfulness versus cognitive behavioural therapy in Tinnitus patients: protocol for a randomised controlled, non-inferiority trial.","INTRODUCTION Chronic subjective tinnitus is a condition that affects 5.1% to 42.7% of the population, depending on the definition and studied population. Evidence-based treatment options are limited. Cognitive Behavioural Therapy (CBT) has been proven effective to improve quality of life and to diminish tinnitus distress. Positive short-term effects of mindfulness-based interventions on tinnitus distress have been reported; however, the longer term effects remain to be studied. METHODS AND ANALYSIS We designed a monocentre randomised controlled, non-inferiority trial to compare the effectiveness of mindfulness-based cognitive therapy (MBCT) and CBT in chronic tinnitus patients. Fifty-four patients (≥32 on the Tinnitus Functional Index (TFI), suffering from tinnitus for at least 6 months) will be included in the trial and randomised into one of two intervention groups. One group will receive MBCT, the other group will receive CBT. Our primary objective is to determine whether MBCT is non-inferior to (as good as) CBT on tinnitus distress (TFI) in chronic tinnitus patients at 12 months follow-up after end of therapy. Non-inferiority will be declared if the mean decrease in TFI score for MBCT is no worse than the mean decrease in TFI score in CBT, with statistical variability, with a margin of 13 points. Most secondary objectives (tinnitus severity of problem, tinnitus intrusiveness, quality of life, anxiety, depression, symptoms of psychopathology, perceived tinnitus complaints, coping style (mostly validated questionnaires)) are expected to show non-inferiority to MBCT compared with CBT. We expect a significant difference between MBCT and CBT for mindfulness awareness. ETHICS AND DISSEMINATION This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL67838.041.18, V.4, April 2019). The trial results will be made accessible to the public in a peer-review journal. TRIAL REGISTRATION NUMBER NL7745.",2020,"Most secondary objectives (tinnitus severity of problem, tinnitus intrusiveness, quality of life, anxiety, depression, symptoms of psychopathology, perceived tinnitus complaints, coping style (mostly validated questionnaires)) are expected to show non-inferiority to MBCT compared with CBT.","['Fifty-four patients (≥32 on the Tinnitus Functional Index (TFI), suffering from tinnitus for at least 6\u2009months', 'chronic tinnitus patients', 'Tinnitus patients']","['MBCT and CBT', 'cognitive behavioural therapy', 'Cognitive Behavioural Therapy (CBT', 'mindfulness-based cognitive therapy (MBCT) and CBT', 'mindfulness-based interventions', 'MBCT', 'CBT']","['objectives (tinnitus severity of problem, tinnitus intrusiveness, quality of life, anxiety, depression, symptoms of psychopathology, perceived tinnitus complaints, coping style (mostly validated questionnaires', 'quality of life', 'TFI score', 'tinnitus distress (TFI']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.158599,"Most secondary objectives (tinnitus severity of problem, tinnitus intrusiveness, quality of life, anxiety, depression, symptoms of psychopathology, perceived tinnitus complaints, coping style (mostly validated questionnaires)) are expected to show non-inferiority to MBCT compared with CBT.","[{'ForeName': 'Maaike Maartje', 'Initials': 'MM', 'LastName': 'Rademaker', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands m.m.rademaker-3@umcutrecht.nl.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Stegeman', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Lieftink', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Metten', 'Initials': 'M', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stokroos', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Adriana L', 'Initials': 'AL', 'LastName': 'Smit', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-033210'] 750,32024790,Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial.,"INTRODUCTION One potential stressor that can affect preimplantation and postimplantation embryonic growth after in vitro fertilisation (IVF) is the pH of the human embryo culture medium, but no evidence exists to indicate which pH level is optimal for IVF. Based on anecdotal evidence or mouse models, culture media manufacturers recommend a pH range of 7.2 to 7.4, and IVF laboratories routinely use a pH range of 7.25 to 7.3. Given the lack of randomised trials evaluating the effect of pH on live birth rate after IVF, this trial examines the effect of three different pH levels on the live birth rate. METHODS AND ANALYSIS This multicentre randomised trial will involve centres specialised in IVF in Egypt. Eligible couples for intracytoplasmic sperm injection (ICSI) will be randomised for embryo culture at pH 7.2, 7.3 or 7.4. The study is designed to detect 10 percentage points difference in live birth rate between the best and worst performing media with 93% power at a 1% significance level. The primary outcome is the rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation) after ICSI. Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation). Embryo development outcomes include fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation. ETHICS AND DISSEMINATION The study was reviewed and approved by the Ethics Review Boards of the participating centres. Eligible women will sign a written informed consent before enrolment. This study has an independent data monitoring and safety committee comprised international experts in trial design and in vitro culture. No plan exists to disseminate results to participants or health communities, except for the independent monitoring and safety committee of the trial. TRIAL REGISTRATION NUMBER NCT02896777.",2020,"Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation).",['live birth after ICSI in Egyptian IVF facilities'],"['pH', 'pH (Tri-pH', 'intracytoplasmic sperm injection (ICSI']","['rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation', 'fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation', 'biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1\u2009year from randomisation', 'live birth rate']","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0010405', 'cui_str': 'Cryofixation'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.6584,"Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fawzy', 'Affiliation': 'Ibnsina IVF Centre, IbnSina Hospital, Sohag, Egypt drfawzy001@me.com.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Emad', 'Affiliation': 'Ibnsina IVF Centre, IbnSina Hospital, Sohag, Egypt.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Centre for Biostatistics, University of Manchester, Manchester, UK.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Mansour', 'Affiliation': 'Egyptian IVF-ET Center, Cairo, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mahran', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Assiut University, Faculty of Medicine, Assiut, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fetih', 'Affiliation': 'Department of Obstetrics and Gynecology, Assiut University, Faculty of Medicine, Assiut, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Faculty of Medicine, Sohag, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'AbdelGhafar', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Faculty of Medicine, Sohag, Egypt.'}]",BMJ open,['10.1136/bmjopen-2019-034194'] 751,32029487,Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol.,"INTRODUCTION End-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD. METHODS AND ANALYSIS This international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years' follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness. ETHICS AND DISSEMINATION The CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness. TRIAL REGISTRATION NUMBER Netherlands National Trial Register (NTR 7138).",2020,"In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD.","['1800 ESKD adults treated with HD in nine European countries', 'adults with ESKD']","['high-dose haemodiafiltration versus high-flux haemodialysis', 'HDF versus continuation of conventional high-flux HD']","['cause mortality', 'cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.\nETHICS AND DISSEMINATION', 'cardiovascular mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}]",,0.118782,"In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Blankestijn', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands P.J.Blankestijn@umcutrecht.nl.'}, {'ForeName': 'Kathrin I', 'Initials': 'KI', 'LastName': 'Fischer', 'Affiliation': 'Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Center of Internal Medicine and Dermatology, Department of Psychosomatic Medicine, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Barth', 'Affiliation': 'B. Braun Avitum AG, Medical Scientific Affairs, Melsungen, Germany.'}, {'ForeName': 'Krister', 'Initials': 'K', 'LastName': 'Cromm', 'Affiliation': 'Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg v.d.H, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Canaud', 'Affiliation': 'Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg v.d.H, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'Department of Nephrology, University College of London, London, United Kingdom.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Hegbrant', 'Affiliation': 'Department of Nephrology, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Kit C', 'Initials': 'KC', 'LastName': 'Roes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rose', 'Affiliation': 'Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Center of Internal Medicine and Dermatology, Department of Psychosomatic Medicine, Berlin, Germany.'}, {'ForeName': 'Giovanni Fm', 'Initials': 'GF', 'LastName': 'Strippoli', 'Affiliation': 'Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Robin Wm', 'Initials': 'RW', 'LastName': 'Vernooij', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'G Ardine', 'Initials': 'GA', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Michiel L', 'Initials': 'ML', 'LastName': 'Bots', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-033228'] 752,32029493,Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial.,"INTRODUCTION Scalp nerve block has been proven to be an alternative choice to opioids in multimodal analgesia. However, for the infratentorial space-occupying craniotomy, especially the suboccipital retrosigmoid craniotomy, scalp nerve block is insufficient. METHODS AND ANALYSIS The study is a prospective, single-centre, randomised, paralleled-group controlled trial. Patients scheduled to receive elective suboccipital retrosigmoid craniotomy will be randomly assigned to the superficial cervical plexus block group or the control group. After anaesthesia induction, superficial cervical plexus nerve block will be performed under the guidance of ultrasound. The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery. Secondary outcomes include the cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score. ETHICS AND DISSEMINATION The protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER NCT04036812.",2020,The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery.,['patients undergoing craniotomy via suboccipital retrosigmoid approach'],"['Ultrasound-guided superficial cervical plexus block for analgesia', 'elective suboccipital retrosigmoid craniotomy', 'superficial cervical plexus block group or the control group']","['cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score', 'cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach (qualifier value)'}, {'cui': 'C0442178', 'cui_str': 'Retrosigmoid approach (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block (procedure)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach (qualifier value)'}, {'cui': 'C0442178', 'cui_str': 'Retrosigmoid approach (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]",,0.194922,The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery.,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dexiang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China florapym766@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034003'] 753,27872384,Dismantling prevention: Comparison of outcomes following media literacy and appearance comparison modules in a randomised controlled trial.,"A dismantling study of body dissatisfaction prevention was conducted. Adolescent girls ( N = 260) were randomly allocated to a media literacy (Happy Being Me - Media Literacy) or appearance comparison (Happy Being Me - Appearance Comparison) intervention or healthy eating behaviour control (Happy Being Me - Healthy Eating Behaviour) condition. In the Happy Being Me - Appearance Comparison condition, improvements from baseline to post-programme and follow-up for upward appearance comparison and fear of negative appearance evaluation were observed. In the Happy Being Me - Media Literacy condition, improvements were observed from baseline to post-programme for upward appearance comparison and realism scepticism. Findings were similar in a high-risk subsample and overall are moderately supportive of appearance comparison-based interventions, but less supportive of a stand-alone media literacy intervention.",2019,"In the Happy Being Me - Media Literacy condition, improvements were observed from baseline to post-programme for upward appearance comparison and realism scepticism.",['Adolescent girls ( N\u2009=\u2009260'],['media literacy (Happy Being Me - Media Literacy) or appearance comparison (Happy Being Me - Appearance Comparison) intervention or healthy eating behaviour control'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],260.0,0.0184165,"In the Happy Being Me - Media Literacy condition, improvements were observed from baseline to post-programme for upward appearance comparison and realism scepticism.","[{'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'La Trobe University, Australia.'}, {'ForeName': 'Eleanor H', 'Initials': 'EH', 'LastName': 'Wertheim', 'Affiliation': 'La Trobe University, Australia.'}, {'ForeName': 'Mathew D', 'Initials': 'MD', 'LastName': 'Marques', 'Affiliation': 'La Trobe University, Australia.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Paxton', 'Affiliation': 'La Trobe University, Australia.'}]",Journal of health psychology,['10.1177/1359105316678668'] 754,30690430,The relationship between self-report and performance-based measures of physical function following an ICU stay.,"PURPOSE To examine relationships between self-report and performance-based measures of physical function in ICU patients randomized to standardized rehabilitation therapy (SRT) or usual care (UC). METHODS Physical function was assessed in 257 ICU patients using self-report (physical functioning scale of the SF-36 (SF-36 PFS)) and the functional performance inventory-short form (FPI-SF) as well as performance-based measures (Short Physical Performance Battery (SPPB)) and muscular strength (MS). Assessments were at hospital discharge, 2, 4, and 6 months. RESULTS Correlations between self-report and performance-based measures were not significantly different between the two groups. When examining the entire cohort, a significant, but weak, correlation (r = 0.286) was found between the SF-36 PFS and the SPPB. At 2 months, moderate correlations were found between self-report and performance-based measures. The SF-36 PFS and FPI were significantly correlated with the SPPB (r = 0.536 and 0.553, respectively) and muscular strength (r = 0.413 and 0.431, respectively). Similar associations were seen at 4 and 6 months in both groups. CONCLUSION Self-report and performance-based measures of physical function appear to assess different constructs at hospital discharge. Following recovery, these measures converge, but indicate different constructs are being assessed. As such, both self-report and performance-based measures of physical function should be used with ICU patients.",2019,"The SF-36 PFS and FPI were significantly correlated with the SPPB (r = 0.536 and 0.553, respectively) and muscular strength (r = 0.413 and 0.431, respectively).",['257 ICU patients using self-report (physical functioning scale of the SF-36 (SF-36 PFS)) and the'],['standardized rehabilitation therapy (SRT) or usual care (UC'],"['SF-36 PFS and FPI', 'muscular strength', 'functional performance inventory-short form (FPI-SF) as well as performance-based measures (Short Physical Performance Battery (SPPB)) and muscular strength (MS']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}]",257.0,0.0196038,"The SF-36 PFS and FPI were significantly correlated with the SPPB (r = 0.536 and 0.553, respectively) and muscular strength (r = 0.413 and 0.431, respectively).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, USA. Electronic address: berry@wfu.edu.'}, {'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Love', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, USA.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Department of Internal Medicine, Wake Forest University School of Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Rita N', 'Initials': 'RN', 'LastName': 'Bakhru', 'Affiliation': 'Department of Internal Medicine, Wake Forest University School of Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Morris', 'Affiliation': 'Department of Internal Medicine, University of Kentucky, Lexington, KY, USA.'}]",Journal of critical care,['10.1016/j.jcrc.2019.01.020'] 755,31586949,Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study.,"OBJECTIVE To compare disease course in patients with Guillain-Barré syndrome (GBS) with a poor prognosis who were treated with one or with two intravenous immunoglobulin (IVIg) courses. METHODS From the International GBS Outcome Study, we selected patients whose modified Erasmus GBS Outcome Score at week 1 predicted a poor prognosis. We compared those treated with one IVIg course to those treated with two IVIg courses. The primary endpoint, the GBS disability scale at 4 weeks, was assessed with multivariable ordinal regression. RESULTS Of 237 eligible patients, 199 patients received a single IVIg course. Twenty patients received an 'early' second IVIg course (1-2 weeks after start of the first IVIg course) and 18 patients a 'late' second IVIg course (2-4 weeks after start of IVIg). At baseline and 1 week, those receiving two IVIg courses were more disabled than those receiving one course. Compared with the one course group, the adjusted OR for a better GBS disability score at 4 weeks was 0.70 (95%CI 0.16 to 3.04) for the early group and 0.66 (95%CI 0.18 to 2.50) for the late group. The secondary endpoints were not in favour of a second IVIg course. CONCLUSIONS This observational study did not show better outcomes after a second IVIg course in GBS with poor prognosis. The study was limited by small numbers and baseline imbalances. Lack of improvement was likely an incentive to start a second IVIg course. A prospective randomised trial is needed to evaluate whether a second IVIg course improves outcome in GBS.",2020,"Compared with the one course group, the adjusted OR for a better GBS disability score at 4 weeks was 0.70 (95%CI 0.16 to 3.04) for the early group and 0.66 (95%CI 0.18 to 2.50) for the late group.","['237 eligible patients', '199 patients received a single IVIg course', 'patients with Guillain-Barré syndrome (GBS) with a poor prognosis who were treated with one or with two intravenous immunoglobulin (IVIg) courses']",[],"['GBS disability scale', 'GBS disability score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0018378', 'cui_str': 'Landry-Guillain-Barre Syndrome'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",237.0,0.076685,"Compared with the one course group, the adjusted OR for a better GBS disability score at 4 weeks was 0.70 (95%CI 0.16 to 3.04) for the early group and 0.66 (95%CI 0.18 to 2.50) for the late group.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Verboon', 'Affiliation': 'Department of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'van den Berg', 'Affiliation': 'Department of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Cornblath', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Esmee', 'Initials': 'E', 'LastName': 'Venema', 'Affiliation': 'Department of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Gorson', 'Affiliation': ""Department of Neurology, St. Elizabeth's Medical Center, Boston, Massachusetts, USA.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Lunn', 'Affiliation': 'Department of Neurology, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van den Bergh', 'Affiliation': 'Department of Neurology, University Clinic St. Luc, Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harbo', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Bateman', 'Affiliation': 'Department of Neurology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Pereon', 'Affiliation': 'Department of Clinical Neurophysiology, Reference Centre for NMD, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Søren H', 'Initials': 'SH', 'LastName': 'Sindrup', 'Affiliation': 'Department of Neurology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Kusunoki', 'Affiliation': 'Department of Neurology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Royal Victoria Infirmary, Newcastle, UK.'}, {'ForeName': 'Zhahirul', 'Initials': 'Z', 'LastName': 'Islam', 'Affiliation': 'Department of Laboratory Sciences and Services Division, The International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Govindsinh', 'Initials': 'G', 'LastName': 'Chavada', 'Affiliation': 'Department of Neurology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Bart C', 'Initials': 'BC', 'LastName': 'Jacobs', 'Affiliation': 'Department of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Richard A C', 'Initials': 'RAC', 'LastName': 'Hughes', 'Affiliation': 'MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Pieter A', 'Initials': 'PA', 'LastName': 'van Doorn', 'Affiliation': 'Department of Neurology, Erasmus MC, Rotterdam, The Netherlands p.a.vandoorn@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-321496'] 756,31184255,Promoting Adherence to Influenza Vaccination Recommendations in Pediatric Practice.,"OBJECTIVES In the United States, nonadherence to seasonal influenza vaccination guidelines for children and adolescents is common and results in unnecessary morbidity and mortality. We conducted a quality improvement project to improve vaccination rates and test effects of 2 interventions on vaccination guidelines adherence. METHODS We conducted a cluster randomized control trial with 11 primary care practices (PRACTICE) that provided care for 11 293 individual children and adolescents in a children's health care system from September 2015 through April 2016. Practice sites (with their clinicians) were randomly assigned to 4 arms (no intervention [Control], computerized clinical decision support system [CCDSS], web-based training [WBT], or CCDSS and WBT [BOTH]). RESULTS During the study, 55.8% of children and adolescents received influenza vaccination, which improved modestly during the study period compared with the prior influenza season ( P = .009). Actual adherence to recommendations, including dosing, timeliness, and avoidance of missed opportunities, was 46.4% of patients cared for by the PRACTICE. The WBT was most effective in promoting adherence with vaccination recommendations with an estimated average odds ratio = 1.26, P < .05, to compare between preintervention and intervention periods. Over the influenza season, there was a significantly increasing trend in odds ratio in the WBT arm ( P < .05). Encouraging process improvements and providing longitudinal feedback on monthly rate of vaccination sparked some practice changes but limited impact on outcomes. CONCLUSIONS Web-based training at the start of influenza season with monthly reports of adherence can improve correct dose and timing of influenza vaccination with modest impact on overall vaccination rate.",2019,"The WBT was most effective in promoting adherence with vaccination recommendations with an estimated average odds ratio = 1.26, P < .05, to compare between preintervention and intervention periods.","['Pediatric Practice', ""11 primary care practices (PRACTICE) that provided care for 11 293 individual children and adolescents in a children's health care system from September 2015 through April 2016""]","['4 arms (no intervention [Control], computerized clinical decision support system [CCDSS], web-based training [WBT], or CCDSS and WBT [BOTH']","['overall vaccination rate', 'vaccination rates', 'odds ratio']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",,0.053822,"The WBT was most effective in promoting adherence with vaccination recommendations with an estimated average odds ratio = 1.26, P < .05, to compare between preintervention and intervention periods.","[{'ForeName': 'Lloyd N', 'Initials': 'LN', 'LastName': 'Werk', 'Affiliation': ""1 Nemours Children's Hospital, Orlando, FL, USA.""}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'Diaz', 'Affiliation': '3 Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cadilla', 'Affiliation': ""1 Nemours Children's Hospital, Orlando, FL, USA.""}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Franciosi', 'Affiliation': ""1 Nemours Children's Hospital, Orlando, FL, USA.""}, {'ForeName': 'Md Jobayer', 'Initials': 'MJ', 'LastName': 'Hossain', 'Affiliation': ""5 Nemours Children's Health System, Wilmington, DE, USA.""}]",Journal of primary care & community health,['10.1177/2150132719853061'] 757,32151333,"De-implementation strategy to reduce inappropriate use of intravenous and urinary catheters (RICAT): a multicentre, prospective, interrupted time-series and before and after study.","BACKGROUND Catheter-associated bloodstream infections and urinary tract infections are frequently encountered health care-associated infections. We aimed to reduce inappropriate use of catheters to reduce health care-associated infections. METHODS In this multicentre, interrupted time-series and before and after study, we introduced a de-implementation strategy with multifaceted interventions in seven hospitals in the Netherlands. Adult patients admitted to internal medicine, gastroenterology, geriatic, oncology, or pulmonology wards, and non-surgical acute admission units, and who had a (central or peripheral) venous or urinary catheter were eligible for inclusion. One of the interventions was that nurses in the participating wards attended educational meetings on appropriate catheter use. Data on catheter use were collected every 2 weeks by the primary research physician during the baseline period (7 months) and intervention period (7 months), which were separated by a 5 month transition period. The primary outcomes were percentages of short peripheral intravenous catheters and urinary catheters used inappropriately on the days of data collection. Indications for catheter use were based on international guidelines. This study is registered with Netherlands Trial Register, NL5438. FINDINGS Between Sept 1, 2016, and April 1, 2018, we screened 6157 patients for inclusion, of whom 5696 were enrolled: 2650 patients in the baseline group, and 3046 in the intervention group. Inappropriate use of peripheral intravenous catheters occurred in 366 (22·0%, 95% CI 20·0 to 24·0) of 1665 patients in the baseline group and in 275 (14·4%, 12·8 to 16·0) of 1912 patients in the intervention group (incidence rate ratio [IRR] 0·65, 95% CI 0·56 to 0·77, p<0·0001). Time-series analyses showed an absolute reduction in inappropriate use of peripheral intravenous catheters from baseline to intervention periods of 6·65% (95% CI 2·47 to 10·82, p=0·011). Inappropriate use of urinary catheters occurred in 105 (32·4%, 95% CI 27·3 to 37·8) of 324 patients in the baseline group compared with 96 (24·1%, 20·0 to 28·6) of 398 patients in the intervention group (IRR 0·74, 95% CI 0·56 to 0·98, p=0·013). Time-series analyses showed an absolute reduction in inappropriate use of urinary catheters of 6·34% (95% CI -12·46 to 25·13, p=0·524). INTERPRETATION Our de-implementation strategy reduced inappropriate use of short peripheral intravenous catheters in patients who were not in the intensive care unit. The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size. The strategy appears well suited for broad-scale implementation to reduce health care-associated infections. FUNDING Netherlands Organisation for Health Research and Development.",2020,"The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size.","['patients who were not in the intensive care unit', '6157 patients for inclusion, of whom 5696 were enrolled: 2650 patients in the baseline group, and 3046 in the intervention group', 'Adult patients admitted to internal medicine, gastroenterology, geriatic, oncology, or pulmonology wards, and non-surgical acute admission units, and who had a (central or peripheral) venous or urinary catheter were eligible for inclusion', 'seven hospitals in the Netherlands', 'Between Sept 1, 2016, and April 1, 2018']",['intravenous and urinary catheters (RICAT'],"['incidence rate ratio [IRR', 'Inappropriate use of peripheral intravenous catheters', 'percentages of short peripheral intravenous catheters and urinary catheters used inappropriately on the days of data collection', 'Inappropriate use of urinary catheters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]",6157.0,0.0611152,"The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size.","[{'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Laan', 'Affiliation': 'Infectious Diseases, Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: b.j.laan@amsterdamumc.nl.'}, {'ForeName': 'Jolanda M', 'Initials': 'JM', 'LastName': 'Maaskant', 'Affiliation': 'Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ingrid J B', 'Initials': 'IJB', 'LastName': 'Spijkerman', 'Affiliation': 'Medical Microbiology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marjon J', 'Initials': 'MJ', 'LastName': 'Borgert', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Mieke H', 'Initials': 'MH', 'LastName': 'Godfried', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Berend C', 'Initials': 'BC', 'LastName': 'Pasmooij', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Opmeer', 'Affiliation': 'Clinical Research Unit, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Margreet C', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': 'Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Infectious Diseases, Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30709-1'] 758,32147878,Effect of Tooth Preparation Design on Fracture Resistance of Zirconia-Reinforced Lithium Silicate Overlays.,"PURPOSE To assess the effect of tooth preparation design on fracture resistance of zirconia-reinforced lithium silicate overlays. MATERIALS AND METHODS This study evaluated 50 human maxillary first molars with no caries, restorations or anatomical defects. The teeth were randomly divided into five groups (n = 10/group) based on preparation design for the fabrication of overlay restorations: (O) anatomical occlusal reduction, (OS) anatomical occlusal reduction with round shoulder preparation, (OG) anatomical occlusal reduction with a central groove, (OSG) anatomical occlusal reduction with round shoulder preparation and central groove, and (C) no preparation of tooth (control group). All restorations were fabricated using zirconia-reinforced lithium silicate (Vita Suprinity). The specimens underwent thermomechanical fatigue loading in a masticatory simulator (1.2 million cycles at 98 N). Fracture resistance was measured using a universal testing machine. The mode of failure was determined as well. Data were analyzed using one-way ANOVA followed by Tukey's post-hoc test, paired t-test and Fisher's exact test (α = 0.05). RESULTS Group O showed significantly higher fracture resistance than groups OG and OSG (p = 0.002 and p = 0.001, respectively). The fracture resistance of group OS was significantly higher than that of group OSG (p = 0.008). The fracture resistance of the control group was significantly higher than that of OG and OSG (p = 0.001) and had no significant difference with other groups. CONCLUSIONS Group O (anatomical occlusal reduction alone), which had the most conservative preparation design, yielded the highest fracture resistance.",2020,The fracture resistance of group OS was significantly higher than that of group OSG (P = 0.008).,"['50 human maxillary first molars with no caries, restorations or anatomical defects', 'Fracture Resistance of Zirconia-Reinforced Lithium Silicate Overlays']","['thermomechanical fatigue loading in a masticatory simulator', 'preparation design for the fabrication of overlay restorations: (O) anatomical occlusal reduction, (OS) anatomical occlusal reduction with round shoulder preparation, (OG) anatomical occlusal reduction with a central groove, (OSG) anatomical occlusal reduction with round shoulder preparation and central groove, and (C) no preparation of tooth (control group']","['Fracture resistance', 'fracture resistance of group OS', 'fracture resistance']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0086983', 'cui_str': 'Silicates'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",50.0,0.0246171,The fracture resistance of group OS was significantly higher than that of group OSG (P = 0.008).,"[{'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Falahchai', 'Affiliation': 'Dental Sciences Research Center, Department of Prosthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Yasamin', 'Initials': 'Y', 'LastName': 'Babaee Hemmati', 'Affiliation': 'Dental Sciences Research Center, Department of Orthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Neshandar Asli', 'Affiliation': 'Dental Sciences Research Center, Department of Prosthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Rezaei', 'Affiliation': 'Dental Sciences Research Center, Department of Prosthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13160'] 759,31739184,Phase 2 study of the focal adhesion kinase inhibitor defactinib (VS-6063) in previously treated advanced KRAS mutant non-small cell lung cancer.,"OBJECTIVES KRAS mutations, which occur in approximately 25% of lung adenocarcinoma cases, represent a major unmet clinical need in thoracic oncology. Preclinical studies have demonstrated that KRAS mutant NSCLC cell lines and xenografts with additional alterations in either TP53 or CDKN2A (INK4A/ARF) loci are sensitive to focal adhesion kinase (FAK) inhibition. Defactinib (VS-6063) is a selective oral inhibitor of FAK. MATERIALS AND METHODS Patients with previously treated advanced KRAS mutant NSCLC were prospectively assigned to one of four molecularly defined cohorts based on the presence or absence of TP53 or CDKN2A alterations and received treatment with defactinib 400 mg orally BID until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS) at 12 weeks. RESULTS Fifty-five patients were enrolled. Mean age was 62 years; 51% were female. The median number of prior lines of therapy was 4 (range 1-8). Fifteen (28%) patients met the 12-week PFS endpoint, with one patient achieving a partial response. Median PFS was 45 days. Clinical efficacy did not correlate with TP53 or CDKN2A status. The most common adverse events were fatigue, gastrointestinal, and increased bilirubin, and were generally grade 1 or 2 in severity. CONCLUSION In heavily pretreated patients with KRAS mutant NSCLC, defactinib monotherapy demonstrated modest clinical activity. Efficacy was not associated with TP53 and CDKN2A status. Defactinib was generally well tolerated.",2020,"The most common adverse events were fatigue, gastrointestinal, and increased bilirubin, and were generally grade 1 or 2 in severity. ","['Patients with previously treated advanced KRAS mutant', 'Mean age was 62\u202fyears; 51% were female', 'heavily pretreated patients with KRAS mutant', 'Fifty-five patients were enrolled', 'previously treated advanced KRAS mutant non-small cell lung cancer']","['focal adhesion kinase inhibitor defactinib (VS-6063', 'defactinib 400\u202fmg orally BID']","['fatigue, gastrointestinal, and increased bilirubin', 'Clinical efficacy', 'tolerated', 'progression-free survival (PFS', 'Efficacy', 'partial response', 'median number of prior lines of therapy', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1565434', 'cui_str': 'Focal Adhesion Protein-Tyrosine Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3899400', 'cui_str': 'defactinib'}, {'cui': 'C2703169', 'cui_str': 'VS-6063'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",55.0,0.0587488,"The most common adverse events were fatigue, gastrointestinal, and increased bilirubin, and were generally grade 1 or 2 in severity. ","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Mail Code 8852, Dallas, TX 75390-8852, USA. Electronic address: david.gerber@utsouthwestern.edu.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Denver, 1665 Aurora Ct, Aurora, CO 80045, USA. Electronic address: ross.camidge@ucdenver.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Morgensztern', 'Affiliation': 'Washington University School of Medicine, 660 S. Euclid Avenue, St. Louis, MO 63110, USA. Electronic address: dmorgens@dom.wustl.edu.'}, {'ForeName': 'Jeremey', 'Initials': 'J', 'LastName': 'Cetnar', 'Affiliation': 'Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OH 97239, USA. Electronic address: cetnarj@ohsu.edu.'}, {'ForeName': 'Ronan J', 'Initials': 'RJ', 'LastName': 'Kelly', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 201 N Broadway St., Baltimore, MD 21287, USA. Electronic address: ronan.kelly@BSWHealth.org.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA 30322, USA. Electronic address: suresh.ramalingam@emory.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, 250 25th Ave N Ste 200, Nashville, TN 37203, USA. Electronic address: david.spigel@sarahcannon.com.'}, {'ForeName': 'Woondong', 'Initials': 'W', 'LastName': 'Jeong', 'Affiliation': 'University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA.'}, {'ForeName': 'Pier P', 'Initials': 'PP', 'LastName': 'Scaglioni', 'Affiliation': 'Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Mail Code 8852, Dallas, TX 75390-8852, USA. Electronic address: SCAGLIPR@ucmail.uc.edu.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Mail Code 8852, Dallas, TX 75390-8852, USA. Electronic address: song.zhang@utsouthwestern.edu.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX 77030, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Weaver', 'Affiliation': 'Verastem, Inc., 117 Kendrick Street, Suite 500, Needham, MA 02494, USA. Electronic address: dweaver@verastem.com.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Vaikus', 'Affiliation': 'Verastem, Inc., 117 Kendrick Street, Suite 500, Needham, MA 02494, USA. Electronic address: lvaikus@verastem.com.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Keegan', 'Affiliation': 'Verastem, Inc., 117 Kendrick Street, Suite 500, Needham, MA 02494, USA. Electronic address: mitch@bostonpharmaceuticals.com.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Horobin', 'Affiliation': 'Verastem, Inc., 117 Kendrick Street, Suite 500, Needham, MA 02494, USA. Electronic address: jhorobin@iderapharma.com.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Burns', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, University of Pittsburgh, 5117 Centre Avenue, Pittsburgh, PA 15213, USA. Electronic address: burnstf@upmc.edu.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.10.033'] 760,27888254,An evaluation of the Aerie Real campaign: Potential for promoting positive body image?,"This study evaluated the impact on young women's body satisfaction of an advertising campaign: Aerie Real, which included images of models who were not digitally modified. In total, 200 female students were randomly allocated to view either Aerie Real images or digitally modified images from previous campaigns. In the total sample, no condition differences appeared. However, participants with high appearance comparison reported a smaller decrease in body satisfaction after viewing the Aerie Real images as compared to those viewing previous images ( p = .003). Findings provide preliminary support for the Aerie Real campaign as less deleterious form of media for body image.",2019,"In the total sample, no condition differences appeared.","['200 female students', ""young women's body satisfaction of an advertising campaign""]",[],['body satisfaction'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",200.0,0.0272247,"In the total sample, no condition differences appeared.","[{'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Convertino', 'Affiliation': 'Northeastern University, USA.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Rodgers', 'Affiliation': 'Northeastern University, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Franko', 'Affiliation': 'Northeastern University, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Jodoin', 'Affiliation': 'Northeastern University, USA.'}]",Journal of health psychology,['10.1177/1359105316680022'] 761,32159313,High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans,"Background Because the reliability of repetitive transcranial magnetic stimulation (rTMS) in treating poststroke cognitive impairment has not been convincingly demonstrated, we systematically examined the effectiveness of this regimen with 2 protocols. Methods We randomly allocated 41 patients with poststroke cognitive impairment to receive 5 Hz rTMS (n = 11), intermittent theta burst stimulation (iTBS; n = 15) or sham stimulation (n = 15). Each group received 10 stimulation sessions over the left dorsolateral prefrontal cortex. We performed the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Beck Depression Inventory at baseline and after the intervention. Results The 5 Hz rTMS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.006), attention (p = 0.001) and delayed memory (p < 0.001). The iTBS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.005) and delayed memory (p = 0.007). The 5 Hz rTMS group exhibited a superior modulating effect in attention compared to the iTBS group (p = 0.016). Patients without comorbid hypertension (p = 0.008) were predisposed to favourable therapeutic outcomes. Limitations Although we included only patients with left hemispheric stroke, heterogeneity associated with cortical and subcortical implications existed. We did not investigate the remote effects of rTMS. Conclusion Our results demonstrated that both 5 Hz rTMS and iTBS were effective for poststroke cognitive impairment in terms of global cognition, attention and memory function; the domain of attention was susceptible to 5 Hz modulation. Treatment with 5 Hz rTMS may slow cognitive decline, representing both a pivotal process in poststroke cognitive impairment and an aspect of neuroplasticity that contributes to disease-modifying strategies. Clinical trial registration NCT02006615; clinicaltrials.gov/ct2/show/NCT02006615.",2020,The iTBS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.005) and delayed memory (p = 0.007).,"['41 patients with poststroke cognitive impairment to', 'poststroke cognitive impairment in humans']","['10 stimulation sessions', 'receive 5 Hz rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Hz rTMS and iTBS', 'intermittent theta burst stimulation (iTBS; n = 15) or sham stimulation', '5 Hz rTMS', 'High-frequency versus theta burst transcranial magnetic stimulation']","['RBANS total score', 'delayed memory', 'Neuropsychological Status (RBANS) and the Beck Depression Inventory', 'comorbid hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",41.0,0.0667168,The iTBS group showed significantly greater improvement than the sham group in RBANS total score (p = 0.005) and delayed memory (p = 0.007).,"[{'ForeName': 'Po-Yi', 'Initials': 'PY', 'LastName': 'Tsai', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Wang-Sheng', 'Initials': 'WS', 'LastName': 'Lin', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Kun-Ting', 'Initials': 'KT', 'LastName': 'Tsai', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Chia-Yu', 'Initials': 'CY', 'LastName': 'Kuo', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}, {'ForeName': 'Pei-Hsin', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan (Tsai, Tsai, Kuo); the National Yang-Ming University, School of Medicine, Taipei, Taiwan (Tsai, W. Lin); the Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan Branch, Yilan, Taiwan (W. Lin, P. Lin).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190060'] 762,32034016,"Neurokinin-1 antagonist orvepitant for EGFRI-induced pruritus in patients with cancer: a randomised, placebo-controlled phase II trial.","OBJECTIVE To evaluate the efficacy of orvepitant (10 or 30 mg given once daily, orally for 4 weeks), a neurokinin-1 receptor antagonist, compared with placebo in reducing the intensity of epidermal growth factor receptor inhibitor (EGFRI)-induced intense pruritus. DESIGN Randomised, double-blind, placebo-controlled clinical trial. SETTING 15 hospitals in Italy and five hospitals in the UK. PARTICIPANTS 44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment. INTERVENTION 30 or 10 mg orvepitant or placebo tablets once daily for 4 weeks (randomised 1:1:1). PRIMARY AND SECONDARY OUTCOME MEASURES The primary endpoint was change from baseline in mean patient-recorded numerical rating scale (NRS) score (over the last three recordings) at week 4. Secondary outcome measures were NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus. RESULTS The trial was terminated early because of recruitment challenges; only 44 of the planned 90 patients were randomised. All patients were analysed for efficacy and safety. Mean NRS score change from baseline to week 4 was -2.78 (SD: 2.64) points in the 30 mg group, -3.04 (SD: 3.06) points in the 10 mg group and -3.21 (SD: 1.77) points in the placebo group; the difference between orvepitant and placebo was not statistically significant. No safety signal was detected. Adverse events related to orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis) were all of mild or moderate severity. CONCLUSIONS Orvepitant was safe and well tolerated. No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint. A number of explanations for this outcome are possible. TRIAL REGISTRATION NUMBER EudraCT2013-002763-25.",2020,No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint.,"['patients with cancer', '15 hospitals in Italy and five hospitals in the UK', '44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment']","['placebo', 'Neurokinin-1 antagonist orvepitant']","['mean patient-recorded numerical rating scale (NRS) score', 'orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis', 'efficacy and safety', 'Mean NRS score change', 'NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus', 'safe and well tolerated', 'safety signal', 'NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C2983799', 'cui_str': 'orvepitant'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2983799', 'cui_str': 'orvepitant'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4274441', 'cui_str': 'Verbal Rating Scale score'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",44.0,0.759463,No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint.,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vincenzi', 'Affiliation': 'Medical Oncology, Universita Campus Bio-Medico di Roma Facolta di Medicina e Chirurgia, Roma, Italy.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Trower', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK mike.trower@nerretherapeutics.com.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Adnovate Clinical Development Strategies, East Sussex, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Guglielmini', 'Affiliation': 'Oncology Unit, ASO SS Antonio e Biagio e C Arrigo, Alessandria, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Harris', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Biometrics Division, Cromsource, Stirling, UK.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Emiliangelo', 'Initials': 'E', 'LastName': 'Ratti', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tonini', 'Affiliation': 'Medical Oncology, Universita Campus Bio-Medico di Roma Facolta di Medicina e Chirurgia, Roma, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Idfac, Devon, UK.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Ständer', 'Affiliation': 'Center for Chronic Pruritus, University Hospital Münster, Münster, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-030114'] 763,32041859,Comparison of autologous osteoperiosteal cylinder and osteochondral graft transplantation in the treatment of large cystic osteochondral lesions of the talus (OLTs): a protocol for a non-inferiority randomised controlled trial.,"INTRODUCTION Large cystic osteochondral lesions of the talus (OLTs) have been shown to have inferior clinical outcomes after reparative techniques such as bone marrow stimulation. Autologous osteochondral transplantation has been viewed as an alternative choice for treating these lesions, but donor-site morbidity has limited its application. Excellent clinical outcomes have been shown in repairing these types of lesions with autologous osteoperiosteal grafts, and these outcomes are achieved at a low cost and without donor-site morbidity in the normal knee joint. This will be the first randomised controlled trial to compare the two surgical techniques, and recommendations for the treatment of patients with large cystic OLTs will be provided. METHODS AND ANALYSIS A non-inferiority randomised controlled trial will be conducted. A total of 70 participants with clinically diagnosed large cystic OLTs will be randomly allocated to either the experimental group or the control group at a ratio of 1:1. The experimental group will be treated with autologous osteoperiosteal cylinder graft transplantation, while the control group will be treated with autologous osteochondral transplantation. The primary outcome measure will be the American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Score and the Short Form 12 (SF-12) questionnaire. Secondary outcome measures will include the secondary arthroscopy International Cartilage Repair Society score, the Magnetic Resonance Observation of Cartilage Repair Tissue score, the Tegner activity level score, the visual analogue scale, routine X-rays, CT and complications. These parameters will be evaluated preoperatively, as well as at 3, 6, 12, 24, 36 and 60 months postoperatively. In this trial, we hypothesised that both procedures offer good results for the treatment of patients with large cystic OLTs, and occurrence of donor-site morbidity in autologous osteoperiosteal cylinder graft transplantation group is less than that in autologous osteochondral transplantation group. ETHICS AND DISSEMINATION The current study was approved by the board of research ethics of Peking University Third Hospital Medical Science Research Ethics Committee. The results of this study will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03347877.",2020,"In this trial, we hypothesised that both procedures offer good results for the treatment of patients with large cystic OLTs, and occurrence of donor-site morbidity in autologous osteoperiosteal cylinder graft transplantation group is less than that in autologous osteochondral transplantation group. ","['large cystic osteochondral lesions of the talus (OLTs', '70 participants with clinically diagnosed large cystic OLTs', 'patients with large cystic OLTs']","['autologous osteochondral transplantation', 'autologous osteoperiosteal cylinder and osteochondral graft transplantation', 'Autologous osteochondral transplantation', 'autologous osteoperiosteal cylinder graft transplantation']","['American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Score and the Short Form 12 (SF-12) questionnaire', 'secondary arthroscopy International Cartilage Repair Society score, the Magnetic Resonance Observation of Cartilage Repair Tissue score, the Tegner activity level score, the visual analogue scale, routine X-rays, CT and complications', 'occurrence of donor-site morbidity']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205207', 'cui_str': 'Cystic (qualifier value)'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0039277', 'cui_str': 'Astragalus Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture (morphologic abnormality)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",70.0,0.177313,"In this trial, we hypothesised that both procedures offer good results for the treatment of patients with large cystic OLTs, and occurrence of donor-site morbidity in autologous osteoperiosteal cylinder graft transplantation group is less than that in autologous osteochondral transplantation group. ","[{'ForeName': 'En', 'Initials': 'E', 'LastName': 'Deng', 'Affiliation': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Qinwei', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing, China guoqinwei@vip.sina.com.'}]",BMJ open,['10.1136/bmjopen-2019-033850'] 764,31286656,Feasibility and effectiveness of two built environmental interventions on physical activity among 3-5-year-old preschoolers.,"PURPOSE The purpose was to examine the feasibility and preliminary effectiveness of two built environmental interventions with Head Start preschool children to increase minutes and intensity and total physical activity (PA). DESIGN AND METHODS A prospective, quasi-experimental, repeated measures design was conducted in two Head Start centers. Centers were randomly assigned to one of two intervention arms. Intervention Arm I added portable play equipment to the school environment; Arm II introduced portable play equipment plus PA education for staff and children. PA was measured during school using accelerometers and by observation using SOPLAY. The data were analyzed using repeated measures ANOVA. RESULTS Ninety-seven children and eight staff were enrolled; valid PA data were available for 56 children (58%). Minutes of PA were highest at baseline in both groups and declined over the intervention. PA in Arm I decreased 22 min from weeks one to three and 12 min (p < .001) from weeks 3 to 6. In Arm II, PA declined 33 min from weeks one to three and 20 min (p < .001) from weeks 3 to 6. PRACTICE IMPLICATIONS Nurses work to maintain and improve health at multiple levels of influence and are in strategic positions to educate and support PA to maintain and improve the health of all ages. School-based PA interventions have been reported with varying success. The feasibility of this study provides insight into the challenges in planning and conducting school-based interventions including enrollment, attrition, and accelerometer wear-time compliance. Despite our interventions, there was no positive response to either intervention, with PA declining at each time period in both groups. However, baseline PA was significantly higher than in previous studies. Schools can provide children with opportunities to accumulate PA.",2019,"In Arm II, PA declined 33 min from weeks one to three and 20 min (p < .001) from weeks 3 to 6. ","['3-5-year-old\xa0preschoolers', 'Head Start preschool children', 'Ninety-seven children and eight staff']","['built environmental interventions', 'School-based PA interventions']","['physical activity', 'baseline PA', 'PA', 'intensity and total physical activity (PA']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C0026118', 'cui_str': 'Situational Therapy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",97.0,0.0223241,"In Arm II, PA declined 33 min from weeks one to three and 20 min (p < .001) from weeks 3 to 6. ","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Robinson', 'Affiliation': 'School of Nursing, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Temple', 'Affiliation': 'Division of Associate Degree Nursing, Southwest Mississippi Community College, Summit, Mississippi.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Duck', 'Affiliation': 'School of Nursing, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Klamm', 'Affiliation': 'School of Nursing, University of Mississippi Medical Center, Jackson, Mississippi.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12262'] 765,32079472,Probiotics maintain the intestinal microbiome homeostasis of the sailors during a long sea voyage.,"The challenging conditions encountered during long sea voyages increase the risk of health-threatening physiological and psychological stress for sailors compared with land-based workers. However, how the intestinal microbiota responds to a long sea voyage and whether there is a feasible approach for protecting gut health during sea voyage are still unexplored. Here, we designed a 30-d longitudinal study including a placebo group ( n = 42) and a probiotic group ( n = 40) and used shotgun metagenomic sequencing to explore the impacts of sea voyage on the intestinal microbiome of sailors. By comparing the intestinal microbiome of subjects in the placebo group at baseline (d 0) and at the end of the sea voyage (d 30), we observed an alteration in the intestinal microbiome during the long sea voyage based on the microbial structure; the results revealed an increase in the species Streptococcus gordonii and Klebsiella pneumoniae as well as a decrease in some functional features. However, the change in the microbial structure of sailors in the probiotic group between d 0 and d 30 was limited, which indicated a maintenance effect of probiotics on intestinal microbiome homeostasis. At the metagenomic strain level, a generally positive correlation was observed between probiotics and the strains belonging to Bifidobacterium longum and Bifidobacterium animalis , whereas a common negative correlation was observed between probiotics and Clostridium leptum ; this result revealed the potential mechanism of maintaining intestinal microbiome homeostasis by probiotics. The present study provided a feasible approach for protecting gut health during a long sea voyage.",2020,"At the metagenomic strain level, a generally positive correlation was observed between probiotics and the strains belonging to Bifidobacterium longum and Bifidobacterium animalis , whereas a common negative correlation was observed between probiotics and Clostridium leptum ; this result revealed the potential mechanism of maintaining intestinal microbiome homeostasis by probiotics.",[],"['Probiotics', 'probiotic group ( n = 40) and used shotgun metagenomic sequencing', 'placebo']","['intestinal microbiome homeostasis', 'risk of health-threatening physiological and psychological stress']",[],"[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037003', 'cui_str': 'Shotguns'}, {'cui': 'C2717799', 'cui_str': 'Population Genomics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]",,0.0335748,"At the metagenomic strain level, a generally positive correlation was observed between probiotics and the strains belonging to Bifidobacterium longum and Bifidobacterium animalis , whereas a common negative correlation was observed between probiotics and Clostridium leptum ; this result revealed the potential mechanism of maintaining intestinal microbiome homeostasis by probiotics.","[{'ForeName': 'Jiachao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Jinshan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'College of Animal Science, Qingdao Agricultural University , Qingdao, P. R. China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Lv', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of General Surgery, 971 Hospital , Qingdao, P. R. China.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'De', 'Affiliation': 'Department of General Surgery, 971 Hospital , Qingdao, P. R. China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, 971 Hospital , Qingdao, P. R. China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}]",Gut microbes,['10.1080/19490976.2020.1722054'] 766,31467392,Attenuation of antidepressant and antisuicidal effects of ketamine by opioid receptor antagonism.,"We recently reported that naltrexone blocks antidepressant effects of ketamine in humans, indicating that antidepressant effects of ketamine require opioid receptor activation. However, it is unknown if opioid receptors are also involved in ketamine's antisuicidality effects. Here, in a secondary analysis of our recent clinical trial, we test whether naltrexone attenuates antisuicidality effects of ketamine. Participants were pretreated with naltrexone or placebo prior to intravenous ketamine in a double-blinded crossover design. Suicidality was measured with the Hamilton Depression Rating Scale item 3, Montgomery-Åsberg Depression Rating Scale item 10, and Columbia Suicide Severity Rating Scale. In the 12 participants who completed naltrexone and placebo conditions, naltrexone attenuated the antisuicidality effects of ketamine on all three suicidality scales/subscales (linear mixed model, fixed pretreatment effect, p < 0.01). Results indicate that opioid receptor activation plays a significant role in the antisuicidality effects of ketamine.",2019,"In the 12 participants who completed naltrexone and placebo conditions, naltrexone attenuated the antisuicidality effects of ketamine on all three suicidality scales/subscales (linear mixed model, fixed pretreatment effect, p < 0.01).",[],"['naltrexone or placebo', 'naltrexone and placebo', 'ketamine', 'naltrexone']","['suicidality scales/subscales', 'Suicidality', 'Hamilton Depression Rating Scale item 3, Montgomery-Åsberg Depression Rating Scale item 10, and Columbia Suicide Severity Rating Scale']",[],"[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}]",,0.0448683,"In the 12 participants who completed naltrexone and placebo conditions, naltrexone attenuated the antisuicidality effects of ketamine on all three suicidality scales/subscales (linear mixed model, fixed pretreatment effect, p < 0.01).","[{'ForeName': 'Nolan R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. nolanw@stanford.edu.'}, {'ForeName': 'Boris D', 'Initials': 'BD', 'LastName': 'Heifets', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Brandon S', 'Initials': 'BS', 'LastName': 'Bentzley', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Blasey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Sudheimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hawkins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lyons', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. afschatz@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0503-4'] 767,31039482,Getting to precision psychopharmacology: Combining clinical and genetic information to predict fat gain from aripiprazole.,"INTRODUCTION All atypical antipsychotics are associated with some degree of weight gain. We applied a novel statistical approach to identify moderators of aripiprazole-induced fat gain using clinical and genetic data from a randomized clinical trial (RCT) of treatment resistant depression in older adults. MATERIALS AND METHODS Adults aged ≥60 years with non-response to a prospective trial of venlafaxine were randomized to 12 weeks of aripiprazole augmentation (n = 91) or placebo (n = 90). Dual energy x-ray absorptiometry (DEXA) measured adiposity at baseline and 12 weeks. Independent moderators of total body fat gain were used to generate two combined multiple moderators, one including clinical data alone and one including both clinical and genetic data to characterize individuals who gained fat during aripiprazole augmentation. RESULTS The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49). Individuals who gained adiposity in this study were more likely to be female and younger in age, have lower weight, fasting glucose and lipids at baseline and positive for the HTR2C polymorphism. DISCUSSION These results demonstrate a combined multiple moderator approach, including both clinical and genetic moderators, can be applied to existing clinical trial data to understand adverse treatment effects. This method allowed for more specific characterization of individuals at risk for the outcome of interest. Further work is needed to identify additional genetic moderators and to validate the approach.",2019,"The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49).","['Adults aged ≥60 years with non-response to a prospective trial of', 'older adults']","['Dual energy x-ray absorptiometry (DEXA', 'placebo', 'venlafaxine', 'aripiprazole augmentation', 'aripiprazole-induced fat gain', 'aripiprazole']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",[],,0.0339439,"The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oughli', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Locke', 'Affiliation': 'Washington University School of Medicine, Department of Internal Medicine, St. Louis, MO, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Yingling', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'University of Pittsburgh Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Washington University School of Medicine, Division of Biostatistics, St. Louis, MO, USA.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'University of Pittsburgh Medical Center, Department of Psychiatry, Pittsburgh, PA, USA.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'University of Toronto, Department of Psychiatry and Center for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA; Thriving Mind South Florida, Miami, FL, USA.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Peterson', 'Affiliation': 'Washington University School of Medicine, Department of Internal Medicine, St. Louis, MO, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Müller', 'Affiliation': 'University of Toronto, Department of Psychiatry and Center for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA. Electronic address: nicolg@wustl.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.017'] 768,31806540,"Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND Metastatic castration-resistant prostate cancer is enriched in DNA damage response (DDR) gene aberrations. The TOPARP-B trial aims to prospectively validate the association between DDR gene aberrations and response to olaparib in metastatic castration-resistant prostate cancer. METHODS In this open-label, investigator-initiated, randomised phase 2 trial following a selection (or pick-the-winner) design, we recruited participants from 17 UK hospitals. Men aged 18 years or older with progressing metastatic castration-resistant prostate cancer previously treated with one or two taxane chemotherapy regimens and with an Eastern Cooperative Oncology Group performance status of 2 or less had tumour biopsies tested with targeted sequencing. Patients with DDR gene aberrations were randomly assigned (1:1) by a computer-generated minimisation method, with balancing for circulating tumour cell count at screening, to receive 400 mg or 300 mg olaparib twice daily, given continuously in 4-week cycles until disease progression or unacceptable toxicity. Neither participants nor investigators were masked to dose allocation. The primary endpoint of confirmed response was defined as a composite of all patients presenting with any of the following outcomes: radiological objective response (as assessed by Response Evaluation Criteria in Solid Tumors 1.1), a decrease in prostate-specific antigen (PSA) of 50% or more (PSA50) from baseline, or conversion of circulating tumour cell count (from ≥5 cells per 7·5 mL blood at baseline to <5 cells per 7·5 mL blood). A confirmed response in a consecutive assessment after at least 4 weeks was required for each component. The primary analysis was done in the evaluable population. If at least 19 (43%) of 44 evaluable patients in a dose cohort responded, then the dose cohort would be considered successful. Safety was assessed in all patients who received at least one dose of olaparib. This trial is registered at ClinicalTrials.gov, NCT01682772. Recruitment for the trial has completed and follow-up is ongoing. FINDINGS 711 patients consented for targeted screening between April 1, 2015, and Aug 30, 2018. 161 patients had DDR gene aberrations, 98 of whom were randomly assigned and treated (49 patients for each olaparib dose), with 92 evaluable for the primary endpoint (46 patients for each olaparib dose). Median follow-up was 24·8 months (IQR 16·7-35·9). Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort. Radiological response was achieved in eight (24·2%; 11·1-42·3) of 33 evaluable patients in the 400 mg cohort and six (16·2%; 6·2-32·0) of 37 in the 300 mg cohort; PSA50 response was achieved in 17 (37·0%; 23·2-52·5) of 46 and 13 (30·2%; 17·2-46·1) of 43; and circulating tumour cell count conversion was achieved in 15 (53·6%; 33·9-72·5) of 28 and 13 (48·1%; 28·7-68·1) of 27. The most common grade 3-4 adverse event in both cohorts was anaemia (15 [31%] of 49 patients in the 300 mg cohort and 18 [37%] of 49 in the 400 mg cohort). 19 serious adverse reactions were reported in 13 patients. One death possibly related to treatment (myocardial infarction) occurred after 11 days of treatment in the 300 mg cohort. INTERPRETATION Olaparib has antitumour activity against metastatic castration-resistant prostate cancer with DDR gene aberrations, supporting the implementation of genomic stratification of metastatic castration-resistant prostate cancer in clinical practice. FUNDING Cancer Research UK, AstraZeneca, Prostate Cancer UK, the Prostate Cancer Foundation, the Experimental Cancer Medicine Centres Network, and the National Institute for Health Research Biomedical Research Centres.",2020,"Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort.","['recruited participants from 17 UK hospitals', '161 patients had DDR gene aberrations, 98 of whom were randomly assigned and treated (49 patients for each olaparib dose), with 92 evaluable for the primary endpoint (46 patients for each olaparib dose', 'Patients with DDR gene aberrations', 'metastatic castration-resistant prostate cancer', 'patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B', 'Men aged 18 years or older with progressing metastatic castration-resistant prostate cancer previously treated with one or two taxane chemotherapy regimens and with an Eastern Cooperative Oncology Group performance status of 2 or less had tumour biopsies tested with targeted sequencing', '711 patients consented for targeted screening between April 1, 2015, and Aug 30, 2018']",['Olaparib'],"['prostate-specific antigen (PSA) of 50% or more (PSA50) from baseline, or conversion of circulating tumour cell count', 'anaemia', 'PSA50 response', 'Radiological response', 'radiological objective response', '19 serious adverse reactions', 'circulating tumour cell count conversion', 'Safety', 'composite response']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0012899', 'cui_str': 'DNA Repair'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",711.0,0.409267,"Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort.","[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Bianchini', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'McGovern', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow and Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Ralph', 'Affiliation': ""St James's Institute of Oncology, University of Leeds, Leeds, UK.""}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University, Belfast, UK.""}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Varughese', 'Affiliation': 'Musgrove Park Hospital, Taunton, UK.'}, {'ForeName': 'Omi', 'Initials': 'O', 'LastName': 'Parikh', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Royal Sussex County Hospital, Brighton, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'McLaren', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Lancaster Infirmary, Lancaster, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Tanguay', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Miranda', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Figueiredo', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Seed', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bertan', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Flohr', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Berni', 'Initials': 'B', 'LastName': 'Ebbs', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Rescigno', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Fowler', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Riisnaes', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Curcean', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chandler', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Gurel', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nava Rodrigues', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter McCallum Cancer Center, Melbourne, VIC, Australia.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Espinasse', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chatfield', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Tunariu', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Carreira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: johann.de-bono@icr.ac.uk.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30684-9'] 769,32028023,Topical 5% minoxidil versus topical 0.2% glyceryl trinitrate in treatment of chronic anal fissure: A randomized clinical trial.,"BACKGROUND Chronic anal fissure (CAF) is a common painful anal condition. Medical treatment of CAF involves the use of agents that induce chemical sphincterotomy. The present trial aimed to compare the efficacy and safety of topical minoxidil and glyceryl trinitrate (GTN) preparations in treatment of CAF. METHODS Adult patients with CAF were randomly assigned to one of two equal groups; group I received topical 5% minoxidil gel and group II received topical 0.2% GTN cream. The main outcome measures were healing of anal fissure, duration to healing, relief of symptoms, and adverse effects. RESULTS 62 patients (36 female and 26 male) were included to the study. Group I comprised 30 patients and group II comprised 32 patients. Healing of anal fissure was achieved in 23 (76.7%) patients in group I and 15 (46.9%) patients in group II (p = 0.03). The average duration to healing in group I was significantly shorter than group II (4.1 ± 1.9 vs 5.3 ± 2.7 weeks, p = 0.048). Adverse effects were recorded in 2 (6.6%) patients in group I and 13 (40.6%) patients in group II. The post-treatment pain score in the GTN group was significantly lower than the Minoxidil group. CONCLUSION Topical 5% minoxidil gel achieved greater and quicker healing of CAF and fewer adverse effects than topical 0.2% GTN cream. Post-treatment pain scores after GTN were significantly lower than minoxidil. TRIAL REGISTRATION NUMBER NCT03528772.",2020,Healing of anal fissure was achieved in 23 (76.7%) patients in group,"['Chronic Anal Fissure', '62 patients (36 female and 26 male', 'Adult patients with CAF']","['Minoxidil', 'topical 5% minoxidil gel and group II received topical 0.2% GTN cream', 'minoxidil', 'CAF', 'minoxidil gel', 'Topical 5% Minoxidil versus Topical 0.2% Glyceryl Trinitrate', 'topical minoxidil and glyceryl trinitrate (GTN']","['healing of anal fissure, duration to healing, relief of symptoms, and adverse effects', 'average duration to healing', 'efficacy and safety', 'adverse effects', 'Adverse effects', 'Healing of anal fissure', 'post-treatment pain score', 'pain scores', 'quicker healing of CAF']","[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0016167', 'cui_str': 'Anal Fissure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1291732', 'cui_str': 'Treatment pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",62.0,0.0357327,Healing of anal fissure was achieved in 23 (76.7%) patients in group,"[{'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: sameh200@hotmail.com.'}, {'ForeName': 'Mohamed Anwar', 'Initials': 'MA', 'LastName': 'Abdel-Razik', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: drmohamedanwar1981@yahoo.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elshobaky', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: elshobakyayman@yahoo.com.'}, {'ForeName': 'Samy Abbas', 'Initials': 'SA', 'LastName': 'Elbaz', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: sami_mrcsed@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khafagy', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: wkhafagy@yahoo.com.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Shalaby', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: mostafashalaby@mans.edu.eg.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.01.143'] 770,30882151,Variants in the CHRNA5-CHRNA3-CHRNB4 Region of Chromosome 15 Predict Gastrointestinal Adverse Events in the Transdisciplinary Tobacco Use Research Center Smoking Cessation Trial.,"INTRODUCTION Reducing adverse events from pharmacologic treatment is an important goal of precision medicine and identifying genetic predictors of adverse events is a step toward this goal. In 2012, King et al. reported associations between genetic variants and adverse events in a placebo-controlled smoking cessation trial of varenicline and bupropion. Strong associations were found between gastrointestinal adverse events and 11 variants in the CHRNA5-CHRNA3-CHRNB4 region of chromosome 15, a region repeatedly associated with smoking-related phenotypes. Our goal was to replicate, in an independent sample, the impact of variants in the CHRNA5-CHRNA3-CHRNB4 region on gastrointestinal adverse events and to extend the analyses to adherence and smoking cessation. METHODS The University of Wisconsin Transdisciplinary Tobacco Use Research Center (TTURC) conducted a multiarmed, placebo-controlled smoking cessation trial of bupropion and nicotine replacement therapy that included 985 genotyped European-ancestry participants. We evaluated relationships between our key variables using logistic regression. RESULTS Gastrointestinal adverse events were experienced by 31.6% TTURC participants. Each of the CHRNA5-CHRNA3-CHRNB4 associations from the King et al. study was found in TTURC, with the same direction of effect. Neither these variants nor the gastrointestinal adverse events themselves were associated with adherence to medication or successful smoking cessation. CONCLUSIONS Variants in the CHRNA5-CHRNA3-CHRNB4 region of chromosome 15 are associated with gastrointestinal adverse events in smoking cessation. Additional independent variants in this region strengthen the association. The consistency between the results of these two independent studies supports the conclusion that these findings reflect biological response to the use of smoking cessation medication. IMPLICATIONS The fact that our findings from the TTURC smoking cessation trial support the independent findings of King et al. suggest that associations of variants in the CHRNA5-CHRNA3-CHRNB4 region of chromosome 15 with gastrointestinal adverse events while taking medications for smoking cessation reflect biology. However, although adherence to medication was a strong predictor of successful smoking cessation in TTURC, neither adverse events nor the genetic variants associated with them predicted either adherence or successful cessation in this study. Thus, although we should strive to minimize adverse events during treatment, we should not expect that to increase successful smoking cessation substantially.",2020,"Strong associations were found between gastrointestinal adverse events and 11 variants in the CHRNA5-CHRNA3-CHRNB4 region of chromosome 15, a region repeatedly associated with smoking-related phenotypes.","['985 genotyped European-ancestry participants', 'The University of Wisconsin Transdisciplinary Tobacco Use Research Center (TTURC) conducted a multi-armed, placebo-controlled smoking cessation trial of']","['bupropion and nicotine replacement therapy (NRT', 'varenicline and bupropion']",['Gastrointestinal adverse events'],"[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0206919,"Strong associations were found between gastrointestinal adverse events and 11 variants in the CHRNA5-CHRNA3-CHRNB4 region of chromosome 15, a region repeatedly associated with smoking-related phenotypes.","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Culverhouse', 'Affiliation': 'John T. Milliken Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Yinjiao', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz044'] 771,31281061,Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial.,"BACKGROUND Previous studies have highlighted a relationship between reduction in rate of exacerbations with therapies containing inhaled corticosteroids (ICS) and baseline blood eosinophil count in patients with chronic obstructive pulmonary disease (COPD). The IMPACT trial showed that once-daily single-inhaler triple therapy significantly reduced exacerbations versus dual therapies. Blood eosinophil counts and smoking status could be important modifiers of treatment response to ICS. We aimed to model these relationships and their interactions, including outcomes other than exacerbations. METHODS IMPACT was a phase 3, randomised, double-blind, parallel-group, 52-week global study comparing once-daily single-inhaler triple therapy (fluticasone furoate-umeclidinium-vilanterol) with dual inhaled therapy (fluticasone furoate-vilanterol or umeclidinium-vilanterol). Eligible patients had moderate-to-very-severe COPD and at least one moderate or severe exacerbation in the previous year. We used fractional polynomials to model continuous blood eosinophil counts. We used negative binomial regression for numbers of moderate and severe exacerbations, severe exacerbations, and pneumonia. We modelled differences at week 52 in trough FEV 1 , St George's Respiratory Questionnaire (SGRQ) total score, and Transition Dyspnoea Index using repeated measurements mixed effect models. IMPACT was registered with ClinicalTrials.gov, number NCT02164513. FINDINGS The magnitude of benefit of regimens containing ICS (fluticasone furoate-umeclidinium-vilanterol n=4151 and fluticasone furoate-vilanterol n=4134) in reducing rates of moderate and severe exacerbations increased in proportion with blood eosinophil count, compared with a non-ICS dual long-acting bronchodilator (umeclidinium-vilanterol n=2070). The moderate and severe exacerbation rate ratio for triple therapy versus umeclidinium-vilanterol was 0·88 (95% CI 0·74 to 1·04) at blood eosinophil count less than 90 cells per μL and 0·56 (0·47 to 0·66) at counts of 310 cells per μL or more; the corresponding rate ratio for fluticasone furoate-vilanterol versus umeclidinium-vilanterol was 1·09 (0·91 to 1·29) and 0·56 (0·47 to 0·66), respectively. Similar results were observed for FEV 1 , Transition Dyspnoea Index, and SGRQ total score; however, the relationship with FEV 1 was less marked. At blood eosinophil counts less than 90 cells per μL and at counts of 310 cells per μL or more, the triple therapy versus umeclidinium-vilanterol treatment difference was 40 mL (95% CI 10 to 70) and 60 mL (20 to 100) for trough FEV 1 , -0·01 (-0·68 to 0·66) and 0·30 (-0·37 to 0·97) for Transition Dyspnoea Index score, and -0·01 (-1·81 to 1·78) and -2·78 (-4·64 to -0·92) for SGRQ total score, respectively. Smoking status modified the relationship between observed efficacy and blood eosinophil count for moderate or severe exacerbations, Transition Dyspnoea Index, and FEV 1 , with former smokers being more corticosteroid responsive at any eosinophil count than current smokers. INTERPRETATION This analysis of the IMPACT trial shows that assessment of blood eosinophil count and smoking status has the potential to optimise ICS use in clinical practice in patients with COPD and a history of exacerbations. FUNDING GlaxoSmithKline.",2019,"Smoking status modified the relationship between observed efficacy and blood eosinophil count for moderate or severe exacerbations, Transition Dyspnoea Index, and FEV 1 , with former smokers being more corticosteroid responsive at any eosinophil count than current smokers. ","['chronic obstructive pulmonary disease', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD and a history of exacerbations', 'Eligible patients had moderate-to-very-severe COPD and at least one moderate or severe exacerbation in the previous year']","['ICS (fluticasone furoate-umeclidinium-vilanterol n=4151 and fluticasone furoate-vilanterol n=4134', 'inhaled corticosteroids (ICS', 'triple and dual combination therapy', 'daily single-inhaler triple therapy (fluticasone furoate-umeclidinium-vilanterol) with dual inhaled therapy (fluticasone furoate-vilanterol or umeclidinium-vilanterol']","['FEV 1 , Transition Dyspnoea Index, and SGRQ total score', 'rates of moderate and severe exacerbations', 'Transition Dyspnoea Index score, and -0·01', 'Blood eosinophil counts and smoking status', ""trough FEV 1 , St George's Respiratory Questionnaire (SGRQ) total score, and Transition Dyspnoea Index"", 'moderate and severe exacerbation rate ratio']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.266631,"Smoking status modified the relationship between observed efficacy and blood eosinophil count for moderate or severe exacerbations, Transition Dyspnoea Index, and FEV 1 , with former smokers being more corticosteroid responsive at any eosinophil count than current smokers. ","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA. Electronic address: pascoesteve@yahoo.co.uk.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'GlaxoSmithKline, Brentford, UK; Barts and the London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brusselle', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hartley', 'Affiliation': 'Statistics and Programming, Veramed Ltd, Twickenham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; Medical Department, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, Gower Street, London, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Research Centre on Asthma and COPD, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Pneumologie, Cochin Hospital AP-HP, University Paris Descartes, Paris, France.'}, {'ForeName': 'Ralf J P', 'Initials': 'RJP', 'LastName': 'van der Valk', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, Manchester, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30190-0'] 772,31986096,"Letter by Mordi et al Regarding Article, ""Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial"".",,2020,,"['Patients', 'With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}]",[],[],,0.018247,,"[{'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, United Kingdom.'}, {'ForeName': 'Mohapradeep', 'Initials': 'M', 'LastName': 'Mohan', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, United Kingdom.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, United Kingdom.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.043268'] 773,32022945,A Daily Study Comparing Alcohol-Related Positive and Negative Consequences for Days With Only Alcohol Use Versus Days With Simultaneous Alcohol and Marijuana Use in a Community Sample of Young Adults.,"BACKGROUND Alcohol and marijuana are psychoactive substances commonly used by young adults and are independently associated with numerous acute and long-term consequences. Many young adults engage in simultaneous alcohol and marijuana (SAM) use to cross-fade (i.e., to enhance the effects of intoxication), although the extent to which alcohol use and alcohol-related consequences increase on SAM occasions compared to alcohol-only occasions is unclear. This study examines daily data among a sample of SAM users comparing SAM days to other days when young adults only used alcohol. METHODS A sample of 409 young adults (age 18 to 25; M age  = 21.6, SD = 2.2; 50.9% women) who reported SAM use in the past month completed 2 bursts of 14 days of daily surveys (28 days in total) assessing alcohol use, alcohol-related consequences, and SAM use. RESULTS Multilevel models based on alcohol-only and SAM days (n = 3,016 days; 391 individuals) indicated young adults drank more alcohol on SAM days compared to alcohol-only days (with no marijuana use). Similarly, days with SAM use were associated with more alcohol-related positive and negative consequences. The daily association between SAM use and positive consequences was statistically significant, after accounting for the amount of alcohol consumed; in contrast, the association between SAM use and negative consequences was diminished and nonsignificant. CONCLUSIONS Among young adult SAM users, days with SAM use were associated with more alcohol use and positive consequences compared to days they only drank alcohol. Further examination of the motivational context for engaging in SAM use, as well as potential physiological interactions between alcohol and marijuana use on alcohol's effects, is warranted. Alcohol interventions might benefit from addressing increased alcohol use and alcohol-related consequences as risks associated with SAM use.",2020,"3,016 days; 391 individuals) indicated young adults drank more alcohol on SAM days compared to alcohol-only days (with no marijuana use).","['409 young adults (age 18 to 25; M age \xa0=\xa021.6, SD\xa0=\xa02.2; 50.9% women) who reported SAM use in the past month completed 2 bursts of 14\xa0days of daily surveys (28\xa0days in total) assessing alcohol use, alcohol-related consequences, and SAM use', 'young adults only used alcohol', 'Young Adults']",['Alcohol interventions'],['SAM use and negative consequences'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",409.0,0.0174366,"3,016 days; 391 individuals) indicated young adults drank more alcohol on SAM days compared to alcohol-only days (with no marijuana use).","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, (MEP), University of Minnesota, Minneapolis, Minnesota.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cadigan', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Abdallah', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14279'] 774,31054484,Evacetrapib reduces preβ-1 HDL in patients with atherosclerotic cardiovascular disease or diabetes.,"BACKGROUND AND AIMS Cholesteryl ester transfer protein (CETP) inhibitor-mediated induction of HDL-cholesterol has no effect on the protection from cardiovascular disease (CVD). However, the mechanism is still unknown. Data on the effects of this class of drugs on subclasses of HDL are either limited or insufficient. In this study, we investigated the effect of evacetrapib, a CETP inhibitor, on subclasses of HDL in patients with atherosclerotic cardiovascular disease or diabetes. METHODS Baseline and 3-month post-treatment samples from atorvastatin 40 mg plus evacetrapib 130 mg (n = 70) and atorvastatin 40 mg plus placebo (n = 30) arms were used for this purpose. Four subclasses of HDL (large HDL, medium HDL, small HDL, and preβ-1 HDL) were separated according to their size and quantified by densitometry using a recently developed native polyacrylamide gel electrophoresis (PAGE) system. RESULTS Relative to placebo, while evacetrapib treatment dramatically increased large HDL and medium HDL subclasses, it significantly reduced small HDL (27%) as well as preβ-1 HDL (36%) particles. Evacetrapib treatment reduced total LDL, but also resulted in polydisperse LDL with LDL particles larger and smaller than the LDL subclasses of the placebo group. CONCLUSION Evacetrapib reduced preβ-1 HDL and small HDL in patients with ASCVD or diabetes on statin. Preβ-1 HDL and medium HDL are negatively interrelated. The results could give a clue to understand the effect of CETP inhibitors on cardiovascular outcomes.",2019,(CETP) inhibitor-mediated induction of HDL-cholesterol has no effect on the protection from cardiovascular disease (CVD).,"['patients with ASCVD or diabetes on statin', 'patients with atherosclerotic cardiovascular disease or diabetes']","['placebo', 'Cholesteryl ester transfer protein', 'atorvastatin 40\u202fmg plus evacetrapib 130\u202fmg (n\u202f=\u202f70) and atorvastatin', 'Evacetrapib', 'CETP inhibitors', 'evacetrapib, a CETP inhibitor']","['small HDL', 'preβ-1 HDL and small HDL', 'cardiovascular outcomes', 'total LDL', 'large HDL and medium HDL subclasses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol Ester Transport Protein, CETP'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3252279', 'cui_str': 'evacetrapib'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}]",,0.0551246,(CETP) inhibitor-mediated induction of HDL-cholesterol has no effect on the protection from cardiovascular disease (CVD).,"[{'ForeName': 'Yunqin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cell Biology, SUNY Downstate Medical Center, Brooklyn, NY, USA; Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'School of Pharmacy, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Obstetrics & Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Haozhu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: ge.junbo@zs-hospital.sh.cn.'}, {'ForeName': 'Xian-Cheng', 'Initials': 'XC', 'LastName': 'Jiang', 'Affiliation': 'Department of Cell Biology, SUNY Downstate Medical Center, Brooklyn, NY, USA; School of Pharmacy, Fudan University, Shanghai, China. Electronic address: XJiang@downstate.edu.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2019.04.211'] 775,30329038,"Maribavir for Refractory or Resistant Cytomegalovirus Infections in Hematopoietic-cell or Solid-organ Transplant Recipients: A Randomized, Dose-ranging, Double-blind, Phase 2 Study.","BACKGROUND Cytomegalovirus (CMV) infections that are refractory or resistant (RR) to available antivirals ([val]ganciclovir, foscarnet, cidofovir) are associated with higher mortality in transplant patients. Maribavir is active against RR CMV strains. METHODS Hematopoietic-cell or solid-organ transplant recipients ≥12 years old with RR CMV infections and plasma CMV deoxyribonucleic acid (DNA) ≥1000 copies/mL were randomized (1:1:1) to twice-daily dose-blinded maribavir 400, 800, or 1200 mg for up to 24 weeks. The primary efficacy endpoint was the proportion of patients with confirmed undetectable plasma CMV DNA within 6 weeks of treatment. Safety analyses included the frequency and severity of treatment-emergent adverse events (TEAEs). RESULTS From July 2012 to December 2014, 120 patients were randomized and treated (40 per dose group): 80/120 (67%) patients achieved undetectable CMV DNA within 6 weeks of treatment (95% confidence interval, 57-75%), with rates of 70%, 63%, and 68%, respectively, for maribavir 400, 800, and 1200 mg twice daily. Recurrent on-treatment CMV infections occurred in 25 patients; 13 developed mutations conferring maribavir resistance. Maribavir was discontinued due to adverse events in 41/120 (34%) patients, and 17/41 discontinued due to CMV infections. During the study, 32 (27%) patients died, 4 due to CMV disease. Dysgeusia was the most common TEAE (78/120; 65%) and led to maribavir discontinuation in 1 patient. Absolute neutrophil counts <1000/µL were noted in 12/106 (11%) evaluable patients, with rates similar across doses. CONCLUSIONS Maribavir ≥400 mg twice daily was active against RR CMV infections in transplant recipients; no new safety signals were identified. CLINICAL TRIALS REGISTRATION NCT01611974.",2019,Dysgeusia was the most common TEAE (78/120; 65%) and led to maribavir discontinuation in 1 patient.,"['transplant patients', 'Hematopoietic-cell or solid-organ transplant recipients ≥12 years old with RR CMV infections and plasma CMV deoxyribonucleic acid (DNA', 'Hematopoietic-cell or Solid-organ Transplant Recipients', 'From July 2012 to December 2014, 120 patients']",['undetectable CMV DNA'],"['Dysgeusia', 'Absolute neutrophil counts', 'frequency and severity of treatment-emergent adverse events (TEAEs', 'proportion of patients with confirmed undetectable plasma CMV DNA']","[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]","[{'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]",120.0,0.129525,Dysgeusia was the most common TEAE (78/120; 65%) and led to maribavir discontinuation in 1 patient.,"[{'ForeName': 'Genovefa A', 'Initials': 'GA', 'LastName': 'Papanicolaou', 'Affiliation': 'Infectious Disease Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Fernanda P', 'Initials': 'FP', 'LastName': 'Silveira', 'Affiliation': 'The Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amelia A', 'Initials': 'AA', 'LastName': 'Langston', 'Affiliation': 'The Winship Cancer Institute, Atlanta, Georgia.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Pereira', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Avery', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Uknis', 'Affiliation': 'Shire Pharmaceuticals, Wayne, Pennsylvania.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wijatyk', 'Affiliation': 'Shire Pharmaceuticals, Lexington, Massachusetts.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Shire Pharmaceuticals, Lexington, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': 'The Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Villano', 'Affiliation': 'Shire Pharmaceuticals, Wayne, Pennsylvania.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy706'] 776,32146127,Molecular lymph node staging for bladder cancer patients undergoing radical cystectomy with pelvic lymph node dissection.,"OBJECTIVE Presence of lymph node (LN) metastasis in bladder cancer (BCa) is a main risk factor for tumor recurrence after radical cystectomy (RC). Molecular analysis facilitates detection of small-volume LN metastases with higher sensitivity than standard histopathology. The aim of the present study was to establish molecular LN analysis in BCa patients undergoing RC with lymph node dissection (LND) and to determine its ability to predict tumor recurrence. PATIENTS AND METHODS Five transcripts with overexpression in BCa (FXYD3, KRT17, KRT20, SPINK1, UPKII) were evaluated for molecular LN analysis. We included 76 BCa patients from the prospective, randomized surgical phase-III trial (LEA AUO AB 25/02, NCT01215071) investigating extended vs. limited LND at RC. The primary endpoint was recurrence-free survival (RFS). As control, 136 LNs from 45 patients without BCa were analyzed to determine a threshold for pathologic gene expression. RESULTS About 1,319 LNs were investigated with molecular and histopathologic examination. Histopathology detected 39 LN metastases in 17 (22%) patients. Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+). In addition, FXYD3 reclassified 43 histopathologic negative LNs and 7 (9%) pN0-patients as molecular node-positive (pN0/molN+). Molecular and histopathologic LN status (pN0/molN0 vs. pN0/molN+ vs. pN+/molN+) was significantly associated with locally advanced disease (P = 0.006) and poor RFS (P < 0.001). Median RFS was not reached in LN-negative patients (pN0/molN0), 45 months (95%CI 8-83) in exclusively molecular positive patients (pN0/molN+) and 9 months (95%CI 5-13) in patients with histopathologic and molecular positive LNs (pN+/molN+). CONCLUSIONS Molecular LN analysis with FXYD3 identified additional LN metastases in histopathologic negative LNs and identified patients with elevated risk of tumor recurrence after RC. Thus, molecular LN analysis improves LN staging and might serve as a tool to guide adjuvant treatment.",2020,Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+).,"['45 patients without BCa', '76 BCa patients', 'BCa patients undergoing RC with lymph node dissection (LND', 'bladder cancer patients undergoing radical cystectomy with pelvic lymph node dissection', 'bladder cancer (BCa']","['pN0/molN+ vs. pN+/molN', 'radical cystectomy (RC']","['Median RFS', 'locally advanced disease', 'recurrence-free survival (RFS', 'poor RFS', 'Molecular and histopathologic LN status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",76.0,0.129531,Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+).,"[{'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Heck', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany. Electronic address: Matthias.Heck@tum.de.'}, {'ForeName': 'Florestan J', 'Initials': 'FJ', 'LastName': 'Koll', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Retz', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Autenrieth', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Magg', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Lunger', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Nawroth', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}]",Urologic oncology,['10.1016/j.urolonc.2020.01.018'] 777,31653510,"A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study.","OBJECTIVE Early-phase data have demonstrated induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821. We sought to determine if this combination decreases the hazard of progression or death compared to OPT-821 alone in patients with ovarian cancer in second/third clinical complete remission following chemotherapy. Secondary and translational objectives were overall survival (OS), safety, and immunogenicity. METHODS From 2010-2013, patients were randomized (1:1) to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11). Dose delay or reduction was not permitted. Patients were removed for pre-defined dose-limiting toxicity. RESULTS Of 171 patients randomized, 170 were treated. Most had disease of serous histology (85%), stage 3 disease at diagnosis (77%), and had received 2 prior regimens (68%). 32% received >6 treatment cycles [median 6, each arm (p = 0.33)]. 77% discontinued due to progression, 4% due to toxicity, and 1 due to myeloid dysplastic syndrome (MDS). Maximum toxicities included grade 4 MDS and depression/personality change (1 each, unlikely related), as well as grade 3 gastrointestinal disorders and others (n = 21, 4 related). Lesser adverse events were injection site reactions (82%) and fever (11%). Estimated HR for progression-free survival (PFS) of the vaccine + OPT-821 to OPT-821 arm was 0.98 (95% CI: 0.71-1.36). At a median follow-up of 60 months, median OS was 47 and 46 months, respectively. CONCLUSIONS Vaccine + OPT-821 compared to OPT-821 alone was modestly immunogenic and did not prolong PFS or OS. Multi-remission patients are a viable, well-defined population for exploring innovative consolidation and maintenance approaches. TRIAL REGISTRATION NCT00857545.",2019,"32% received >6 treatment cycles [median 6, each arm (p = 0.33)].","['171 patients randomized, 170 were treated', 'patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study', 'patients with ovarian cancer in second/third clinical complete remission following chemotherapy', 'From 2010-2013']","['OPT-821 alone', 'OPT-821±vaccine-KLH conjugate', 'polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821', 'polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384)\xa0+ OPT-821 versus OPT-821']","['overall survival (OS), safety, and immunogenicity', 'hazard of progression or death', 'disease of serous histology', 'median OS', 'PFS or OS', 'Estimated HR for progression-free survival (PFS', 'fever', 'Maximum toxicities included grade 4 MDS and depression/personality change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0064332', 'cui_str': 'KLH antigen'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1175421', 'cui_str': 'Globo-H'}, {'cui': 'C0119960', 'cui_str': 'GM2(NeuGc)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0240735', 'cui_str': 'Personality change (finding)'}]",170.0,0.384314,"32% received >6 treatment cycles [median 6, each arm (p = 0.33)].","[{'ForeName': 'Roisin E', 'Initials': 'RE', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: ocearbhr@mskcc.org.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'NRG Oncology Statistics & Data Management Center, Roswell Park Cancer Institute, Buffalo, NY, USA. Electronic address: wdeng@gogstats.org.'}, {'ForeName': 'Lee-May', 'Initials': 'LM', 'LastName': 'Chen', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA. Electronic address: lee-may.chen@ucsfmedctr.org.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Lucci', 'Affiliation': 'The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Joseph.A.Lucci@uth.tmc.edu.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Behbakht', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA. Electronic address: kian.behbakht@ucdenver.edu.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: nspirtos@wccenter.com.""}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Muller', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM, USA. Electronic address: cmuller@salud.unm.edu.'}, {'ForeName': 'Benedict B', 'Initials': 'BB', 'LastName': 'Benigno', 'Affiliation': 'University Gynecologic Oncology, Atlanta, GA, USA. Electronic address: benedict.benigno@ugynonc.com.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA. Electronic address: powellm@wudosis.wustl.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Berry', 'Affiliation': ""Northwestern Medicine Prentice Women's Hospital, Chicago, IL, USA. Electronic address: https://dremilyberry.com.""}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California Irvine Medical Center, Orange, CA, USA. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Hanjani', 'Affiliation': 'Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, Abington, PA, USA. Electronic address: phanjani@aol.com.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': 'NRG Oncology, Operations Center-Philadelphia East, Philadelphia PA and Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, USA. Electronic address: LankesH@NRGOncology.org.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: aghajanc@mskcc.org.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Sabbatini', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: sabbatip@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.09.015'] 778,30895944,Skin cancer precursor immunotherapy for squamous cell carcinoma prevention.,"BACKGROUND Topical calcipotriol plus 5-fluorouracil (5-FU) combination is an effective immunotherapy against actinic keratosis (AK), which is a precursor to squamous cell carcinoma (SCC). However, the long-term effectiveness of calcipotriol plus 5-FU treatment for SCC prevention is unknown. METHODS We performed a blinded prospective cohort study on participants of a randomized double-blind clinical trial in which a 4-day course of topical calcipotriol plus 5-FU combination was compared to Vaseline plus 5-FU (control) for AK treatment. SCC and basal cell carcinoma (BCC) incidences were assessed at 1, 2, and 3 years after trial. Tissues were analyzed for calcipotriol plus 5-FU-induced T cell immunity in the skin. RESULTS Calcipotriol plus 5-FU-induced tissue-resident memory T (Trm) cell formation in face and scalp skin associated with significantly higher erythema scores compared with control (P < 0.01). Importantly, more participants in the test cohort remained SCC-free over the more than 1,500-day follow-up period (P = 0.0765), and significantly fewer developed SCC on the treated face and scalp within 3 years (2 of 30 [7%] versus 11 of 40 [28%] in control group, hazard ratio 0.215 [95% CI: 0.048-0.972], P = 0.032). Accordingly, significantly more epidermal Trm cells persisted in the calcipotriol plus 5-FU-treated face and scalp skin compared with control (P = 0.0028). There was no significant difference in BCC incidence between the treatment groups. CONCLUSION A short course of calcipotriol plus 5-FU treatment on the face and scalp is associated with induction of robust T cell immunity and Trm formation against AKs and significantly lowers the risk of SCC development within 3 years of treatment. FUNDING This research was supported by internal academic funds and by grants from the Burroughs Wellcome Fund, Sidney Kimmel Foundation, Cancer Research Institute, and NIH.",2019,"There was no significant difference in BCC incidence between the treatment groups. ",['squamous cell carcinoma prevention'],"['calcipotriol plus 5-FU', 'Skin cancer precursor immunotherapy', 'Topical calcipotriol plus 5-fluorouracil (5-FU) combination', 'Vaseline plus 5-FU (control', 'topical calcipotriol plus 5-FU combination']","['SCC and basal cell carcinoma (BCC) incidences', 'SCC-free', 'BCC incidence', 'erythema scores', 'tissue-resident memory T (Trm) cell formation']","[{'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",,0.042956,"There was no significant difference in BCC incidence between the treatment groups. ","[{'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': 'Division of Dermatology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tabacchi', 'Affiliation': 'Division of Dermatology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Ngo', 'Affiliation': 'Center for Cancer Immunology and Cutaneous Biology Research Center, Department of Dermatology and Center for Cancer Research, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallendorf', 'Affiliation': 'Division of Biostatistics and.'}, {'ForeName': 'Ilana S', 'Initials': 'IS', 'LastName': 'Rosman', 'Affiliation': 'Division of Dermatology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Cornelius', 'Affiliation': 'Division of Dermatology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Shadmehr', 'Initials': 'S', 'LastName': 'Demehri', 'Affiliation': 'Center for Cancer Immunology and Cutaneous Biology Research Center, Department of Dermatology and Center for Cancer Research, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",JCI insight,['10.1172/jci.insight.125476'] 779,31068398,A Cluster Randomized Trial Comparing Strategies for Translating Self-Management Support into Primary Care Practices.,"INTRODUCTION Self-management support (SMS) is a key factor in diabetes care, but true SMS has not been widely adopted by primary care practices. Interactive behavior-change technology (IBCT) can provide efficient methods for adoption of SMS in primary care. Practice facilitation has been effective in assisting practices in implementing complex evidence-based interventions, such as SMS. This study was designed to study the incremental impact of practice education, the Connection to Health (CTH) IBCT tool, and practice facilitation as approaches to enhance the translation of SMS for patients with diabetes in primary care practices. METHODS A cluster-randomized trial compared the effectiveness of 3 implementation strategies for enhancing SMS for patients with diabetes in 36 primary care practices: 1) SMS education (SMS-ED); 2) SMS-ED plus CTH availability (CTH); and 3) SMS-ED, CTH availability, plus brief practice facilitation (CTH + PF). Outcomes including hemoglobin A1c (HbA1c) levels and SMS activities were assessed at 18 months post study initiation in a random sample of patients through medical record reviews. RESULTS A total of 488 patients enrolled in the CTH system (141 CTH, 347 CTH + PF). In the intent-to-treat analysis of patients with medical record reviews, HbA1c slopes did not differ between study arms (CTH vs SMS-ED: P = .2243, CTH + PF vs SMS-ED: P = .8601). However, patients from practices in the CTH + PF arm who used CTH showed significantly improved HbA1c trajectories over time compared with patients from SMS-ED practices ( P = .0422). SMS activities were significantly increased in CTH and CTH + PF study arms compared with SMS-ED (CTH vs SMS-ED: P = .0223, CTH + PF vs SMS-ED: P = .0013). The impact of CTH on SMS activities was a significant mediator of the impact of the CTH and CTH + PF interventions on HbA1c. CONCLUSION An interactive behavior change technology tool such as CTH can increase primary care practice SMS activities and improve patient HbA1c levels. Even brief practice facilitation assists practices in implementing SMS.",2019,"CTH vs SMS-ED: P = .2243, CTH + PF vs SMS-ED: P = .8601).","['488 patients enrolled in the CTH system (141 CTH, 347 CTH + PF', 'patients with diabetes in primary care practices', 'patients with diabetes in 36 primary care practices']","['SMS-ED plus CTH availability (CTH); and 3) SMS-ED, CTH availability, plus brief practice facilitation (CTH + PF', 'CTH and CTH + PF interventions', 'Self-management support (SMS', '3 implementation strategies for enhancing SMS', 'CTH + PF', 'CTH', 'Interactive behavior-change technology (IBCT']","['hemoglobin A1c (HbA1c) levels and SMS activities', 'SMS activities', 'HbA1c trajectories']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",488.0,0.0475032,"CTH vs SMS-ED: P = .2243, CTH + PF vs SMS-ED: P = .8601).","[{'ForeName': 'W Perry', 'Initials': 'WP', 'LastName': 'Dickinson', 'Affiliation': 'From the Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO (WPD, LMD, BTJ, DHF, MC); Department of Family and Community Medicine, University of California-San Francisco, San Francisco, CA (DMH, LF). perry.dickinson@ucdenver.edu.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': 'From the Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO (WPD, LMD, BTJ, DHF, MC); Department of Family and Community Medicine, University of California-San Francisco, San Francisco, CA (DMH, LF).'}, {'ForeName': 'Bonnie T', 'Initials': 'BT', 'LastName': 'Jortberg', 'Affiliation': 'From the Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO (WPD, LMD, BTJ, DHF, MC); Department of Family and Community Medicine, University of California-San Francisco, San Francisco, CA (DMH, LF).'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Hessler', 'Affiliation': 'From the Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO (WPD, LMD, BTJ, DHF, MC); Department of Family and Community Medicine, University of California-San Francisco, San Francisco, CA (DMH, LF).'}, {'ForeName': 'Douglas H', 'Initials': 'DH', 'LastName': 'Fernald', 'Affiliation': 'From the Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO (WPD, LMD, BTJ, DHF, MC); Department of Family and Community Medicine, University of California-San Francisco, San Francisco, CA (DMH, LF).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cuffney', 'Affiliation': 'From the Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO (WPD, LMD, BTJ, DHF, MC); Department of Family and Community Medicine, University of California-San Francisco, San Francisco, CA (DMH, LF).'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO (WPD, LMD, BTJ, DHF, MC); Department of Family and Community Medicine, University of California-San Francisco, San Francisco, CA (DMH, LF).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.03.180254'] 780,31704382,Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.,"OBJECTIVES To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory. METHODS Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254). RESULTS Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes. CONCLUSIONS Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.",2019,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","['535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of', 'patients with OUD']","['BUP-NX', 'XR-NTX', 'buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX', 'naltrexone and buprenorphine-naloxone']","['BUP-NX', 'XR-NTX']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],535.0,0.0141898,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","[{'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Center of Alcohol and Substance Use Studies, Graduate School of Applied and Professional Psychology, Rutgers University, New Brunswick, United States. Electronic address: lesia.ruglass@rutgers.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'New York State Psychiatric Institute, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Biostatistics Department, Mailman School of Public Health, Columbia University, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, York University, Canada.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'College of Nursing, Washington State University, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, United States.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School and McLean Hospital, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University School of Medicine, United States.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107649'] 781,31707827,Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography-Stratified Analysis of ORBITA.,"BACKGROUND Dobutamine stress echocardiography is widely used to test for ischemia in patients with stable coronary artery disease. In this analysis, we studied the ability of the prerandomization stress echocardiography score to predict the placebo-controlled efficacy of percutaneous coronary intervention (PCI) within the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina). METHODS One hundred eighty-three patients underwent dobutamine stress echocardiography before randomization. The stress echocardiography score is broadly the number of segments abnormal at peak stress, with akinetic segments counting double and dyskinetic segments counting triple. The ability of prerandomization stress echocardiography to predict the placebo-controlled effect of PCI on response variables was tested by using regression modeling. RESULTS At prerandomization, the stress echocardiography score was 1.56±1.77 in the PCI arm (n=98) and 1.61±1.73 in the placebo arm (n=85). There was a detectable interaction between prerandomization stress echocardiography score and the effect of PCI on angina frequency score with a larger placebo-controlled effect in patients with the highest stress echocardiography score ( P interaction =0.031). With our sample size, we were unable to detect an interaction between stress echocardiography score and any other patient-reported response variables: freedom from angina ( P interaction =0.116), physical limitation ( P interaction =0.461), quality of life ( P interaction =0.689), EuroQOL 5 quality-of-life score ( P interaction =0.789), or between stress echocardiography score and physician-assessed Canadian Cardiovascular Society angina class ( P interaction =0.693), and treadmill exercise time ( P interaction =0.426). CONCLUSIONS The degree of ischemia assessed by dobutamine stress echocardiography predicts the placebo-controlled efficacy of PCI on patient-reported angina frequency. The greater the downstream stress echocardiography abnormality caused by a stenosis, the greater the reduction in symptoms from PCI. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02062593.",2019,,['Stable Coronary Artery Disease'],"['Placebo', 'Percutaneous Coronary Intervention', 'Dobutamine Stress Echocardiography Ischemia']",[],"[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0949700', 'cui_str': 'Echocardiography, Stress, Dobutamine'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",[],,0.158421,,"[{'ForeName': 'Rasha K', 'Initials': 'RK', 'LastName': 'Al-Lamee', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Shun-Shin', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Howard', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Nowbar', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rajkumar', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Sukhjinder', 'Initials': 'S', 'LastName': 'Nijjer', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keeble', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Malik', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bual', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Yousif', 'Initials': 'Y', 'LastName': 'Ahmad', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Seligman', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Cardiff Royal Infirmary, UK (A.S.P.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerber', 'Affiliation': 'East Sussex Healthcare NHS Trust, Hastings, UK (R.G.).'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth and Christchurch NHS Trust, UK (S. Talwar).'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Assomull', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cole', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Niall G', 'Initials': 'NG', 'LastName': 'Keenan', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK (N.G.K., J.S.).'}, {'ForeName': 'Gajen', 'Initials': 'G', 'LastName': 'Kanaganayagam', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Joban', 'Initials': 'J', 'LastName': 'Sehmi', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK (N.G.K., J.S.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wensel', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Biostatistics, Nashville, TN (F.E.H.).'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Mayet', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042918'] 782,30737889,Acupuncture for patients with mild hypertension: A randomized controlled trial.,"Acupuncture may be beneficial for patients with mild hypertension, but the evidence is not convincing. We aimed to examine the effect of acupuncture on blood pressure (BP) reduction in patients with mild hypertension. We conducted a multicenter, single-blind, sham-controlled, randomized trial in eleven hospitals in China. The trial included 428 patients with systolic blood pressure (SBP) from 140 to 159 mm Hg and/or with diastolic blood pressure (DBP) from 90 to 99 mm Hg. The patients were randomly assigned to receive 18 sessions of affected meridian acupuncture (n = 107) or non-affected meridian acupuncture (n = 107) or sham acupuncture (n = 107) during 6 weeks, or to stay in a waiting-list control (n = 107). All patients received 24-hour ambulatory blood pressure monitoring at weeks 6, 9, and 12. We included 415 participants in the intention-to-treat analysis. The two acupuncture groups were pooled in the analysis, since they had no difference in all outcomes. SBP decreased at week 6 in acupuncture group vs sham acupuncture vs waiting-list group (7.2 ± 11.0 mm Hg vs 4.1 ± 11.5 mm Hg vs 4.1 ± 13.2 mm Hg); acupuncture was not superior to sham acupuncture (mean difference 2.7 mm Hg, 95% CI 0.4 to 5.9, adjusted P = 0.103) or waiting-list control (2.9 mm Hg, 95% CI -0.2 to 6.0, adjusted P = 0.078). However, acupuncture was superior to sham acupuncture (3.3 mm Hg, 95% CI 0.2 to 6.3, adjusted P = 0.035) and waiting-list control (4.8 mm Hg, 95% CI 1.8 to 7.8, P < 0.001) at week 9. Acupuncture had a small effect size on the reduction of BP in patients with mild hypertension.",2019,; acupuncture was not superior to sham acupuncture,"['415 participants in the intention-to-treat analysis', '428 patients with systolic blood pressure (SBP) from 140 to 159\xa0mm', 'eleven hospitals in China', 'patients with mild hypertension', 'Hg']","['Acupuncture', 'sham acupuncture', '24-hour ambulatory blood pressure monitoring', 'meridian acupuncture (n\xa0=\xa0107) or non-affected meridian acupuncture (n\xa0=\xa0107) or sham acupuncture', 'acupuncture']","['diastolic blood pressure (DBP', 'waiting-list control', 'reduction of BP', 'SBP', 'blood pressure (BP) reduction']","[{'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517775', 'cui_str': 'Four hundred and twenty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0085282', 'cui_str': 'Ching Lo'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",428.0,0.57927,; acupuncture was not superior to sham acupuncture,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Yin-Lan', 'Initials': 'YL', 'LastName': 'Huang', 'Affiliation': 'Traditional Chinese Medicine Department, General Hospital of Ningxia Medicine University, Ningxia, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Chang', 'Affiliation': 'Acupuncture and Tuina School, Hunan University of Traditional Chinese Medicine, Changsha, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Acupuncture and Tuina School, Hunan University of Traditional Chinese Medicine, Changsha, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Acupuncture and Tuina School, Guiyang University of Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Rui-Hui', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'Acupuncture and Tuina School, Shaanxi University of Chinese Medicine, Xian, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Acupuncture and Tuina School, Shaanxi University of Chinese Medicine, Xian, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Acupuncture and Tuina Department, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, China.'}, {'ForeName': 'Tai-Pin', 'Initials': 'TP', 'LastName': 'Guo', 'Affiliation': 'Acupuncture and Tuina School, Yunnan University of Traditional Chinese Medicine, Kunming, China.'}, {'ForeName': 'Fan-Rong', 'Initials': 'FR', 'LastName': 'Liang', 'Affiliation': 'Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13490'] 783,32024793,Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach.,"INTRODUCTION This protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary 'Care Support Team'. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability. METHODS AND ANALYSIS The UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of 'usual care'. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model. ETHICS AND DISSEMINATION The primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context. TRIAL REGISTRATION NUMBER ACTRN12617001595303; Pre-results.",2020,PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'.,"['patients with knee osteoarthritis (PARTNER) study', 'patients with knee osteoarthritis (PARTNER']",['telephone advice and support for OA management'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.060044,PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'.,"[{'ForeName': 'Jocelyn L', 'Initials': 'JL', 'LastName': 'Bowden', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, St Leonards, New South Wales, Australia jocelyn.bowden@sydney.edu.au.'}, {'ForeName': 'Thorlene', 'Initials': 'T', 'LastName': 'Egerton', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Briggs', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bunker', 'Affiliation': 'Medibank, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'French', 'Affiliation': 'Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Pirotta', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Schofield', 'Affiliation': 'Centre for Economic Impacts of Genomic Medicine, Macquarie Business School, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Zwar', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, St Leonards, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034526'] 784,30191779,Mamma Mia - A randomized controlled trial of an internet-based intervention for perinatal depression.,"BACKGROUND Studies suggest that 10-15% of perinatal women experience depressive symptoms. Due to the risks, problems with detection, and barriers to treatment, effective universal preventive interventions are needed. The aim of this study was to assess the effectiveness of an automated internet intervention ('Mamma Mia') on perinatal depressive symptoms. Mamma Mia is tailored specifically to the perinatal phase and targets risk and protective factors for perinatal depressive symptoms. METHODS A total of 1342 pregnant women were randomized to an intervention ('Mamma Mia') and control group. Data were collected at gestational week (gw) 21-25, gw37, 6 weeks after birth, and 3 and 6 months after birth. We investigated whether (1) the intervention group displayed lower levels of depressive symptoms compared with the control group, (2) the effect of Mamma Mia changed over time, (3) the effect on depressive symptoms was moderated by baseline depressive symptoms, previous depression, and parity, and (4) this moderation changed by time. Finally, we examined if the prevalence of mothers with possible depression [i.e. Edinburgh Postnatal Depression Scale (EPDS)-score ⩾10] differed between the intervention and control group. RESULTS Participants in the Mamma Mia group displayed less depressive symptoms than participants in the control group during follow-up [F(1) = 7.03, p = 0.008]. There were indications that the effect of Mamma Mia was moderated by EPDS score at baseline. The prevalence of women with EPDS-score ⩾10 was lower in the Mamma Mia group at all follow-up measurements. CONCLUSIONS The study demonstrated the effects of the automated web-based universal intervention Mamma Mia on perinatal depressive symptoms.",2019,"RESULTS Participants in the Mamma Mia group displayed less depressive symptoms than participants in the control group during follow-up [F(1) =",['1342 pregnant women'],"['internet-based intervention', ""automated internet intervention ('Mamma Mia"", 'automated web-based universal intervention Mamma Mia', ""intervention ('Mamma Mia') and control group""]","['perinatal depressive symptoms', 'baseline depressive symptoms, previous depression, and parity, and (4) this moderation changed by time', 'depressive symptoms', 'prevalence of mothers with possible depression [i.e. Edinburgh Postnatal Depression Scale (EPDS)-score ⩾10', 'prevalence of women with EPDS-score ⩾10', 'levels of depressive symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score (observable entity)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1342.0,0.163215,"RESULTS Participants in the Mamma Mia group displayed less depressive symptoms than participants in the control group during follow-up [F(1) =","[{'ForeName': 'Silje Marie', 'Initials': 'SM', 'LastName': 'Haga', 'Affiliation': 'Department for Infant Mental Health,Regional Centre for Child and Adolescent Mental Health,Eastern and Southern Norway, Oslo,Norway.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Drozd', 'Affiliation': 'Department for Infant Mental Health,Regional Centre for Child and Adolescent Mental Health,Eastern and Southern Norway, Oslo,Norway.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Lisøy', 'Affiliation': 'Department for Infant Mental Health,Regional Centre for Child and Adolescent Mental Health,Eastern and Southern Norway, Oslo,Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Wentzel-Larsen', 'Affiliation': 'Department for Infant Mental Health,Regional Centre for Child and Adolescent Mental Health,Eastern and Southern Norway, Oslo,Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Slinning', 'Affiliation': 'Department for Infant Mental Health,Regional Centre for Child and Adolescent Mental Health,Eastern and Southern Norway, Oslo,Norway.'}]",Psychological medicine,['10.1017/S0033291718002544'] 785,32146876,Comparing the efficacy of integrative body-mind-spirit intervention with cognitive behavioral therapy in patient-caregiver parallel groups for lung cancer patients using a randomized controlled trial.,"Purposes/objectives: This paper reports the comparative efficacies of integrative body-mind-spirit intervention (I-BMS) and cognitive behavioral therapy (CBT) in patient-caregiver parallel groups for Chinese patients with lung cancer. Design: Randomized controlled trial (RCT). Methods: One hundred and fifty-seven patient-caregiver dyads with no marked functional impairment were randomized into one of the two interventions with eight weekly patient-caregiver parallel groups. Assessments were conducted at baseline, within one, eight- and sixteen-weeks post-intervention. Effects of treatment group across time were analyzed by multilevel modeling. Findings: CBT led to greater reduction in emotional vulnerability than I-BMS. I-BMS resulted in greater increase in overall QoL and spiritual self-care, and more reduction in depression than CBT. Patients in both interventions experienced improvement in physical, emotional and spiritual, except social, domains of QoL. Conclusion: I-BMS was more efficacious for diverse domains of QoL, and CBT was more effective for emotional well-being, despite the relatively small between-group effect sizes. Implications for psychosocial providers/policy: (1) With the expanding repertoire of psychosocial interventions for families facing lung cancer, it has become imperative to investigate the comparative efficacies of empirically supported and culturally adapted interventions. (2) Our findings show that I-BMS was more effective for diverse domains of QoL, while CBT was more efficacious with emotional well-being, although both interventions led to significant improvements in physical, emotional and spiritual domains of patient QoL. (3) Patient-caregiver parallel groups have been shown to be effective for enhancing QoL of Chinese lung cancer patients. (4) Care professionals are encouraged to dispense interventions based on the idiosyncratic needs and preferences of the patients to maximize the treatment effects.",2020,"I-BMS resulted in greater increase in overall QoL and spiritual self-care, and more reduction in depression than CBT.","['Chinese lung cancer patients', 'Methods: One hundred and fifty-seven patient-caregiver dyads with no marked functional impairment', 'patient-caregiver parallel groups for lung cancer patients', 'patient-caregiver parallel groups for Chinese patients with lung cancer', 'families facing lung cancer']","['CBT', 'integrative body-mind-spirit intervention (I-BMS) and cognitive behavioral therapy (CBT', 'integrative body-mind-spirit intervention with cognitive behavioral therapy']","['physical, emotional and spiritual, except social, domains of QoL. Conclusion: I-BMS', 'emotional vulnerability', 'overall QoL and spiritual self-care']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]",,0.0356158,"I-BMS resulted in greater increase in overall QoL and spiritual self-care, and more reduction in depression than CBT.","[{'ForeName': 'Bobo H P', 'Initials': 'BHP', 'LastName': 'Lau', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, Hong Kong.'}, {'ForeName': 'Amy Y M', 'Initials': 'AYM', 'LastName': 'Chow', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ting-Kin', 'Initials': 'TK', 'LastName': 'Ng', 'Affiliation': 'Wofoo Joseph Lee Consulting and Counselling Psychology Research Centre, Lingnan University, Hong Kong.'}, {'ForeName': 'Yat-Lui', 'Initials': 'YL', 'LastName': 'Fung', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai-Chung', 'Initials': 'TC', 'LastName': 'Lam', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tsz-Him', 'Initials': 'TH', 'LastName': 'So', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jessie S M', 'Initials': 'JSM', 'LastName': 'Chan', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Celia H Y', 'Initials': 'CHY', 'LastName': 'Chan', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Michelle Y J', 'Initials': 'MYJ', 'LastName': 'Tam', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Miu-Wah', 'Initials': 'MW', 'LastName': 'Tsang', 'Affiliation': 'Hong Kong Cancer Fund, Hong Kong.'}, {'ForeName': 'Nikki S Y', 'Initials': 'NSY', 'LastName': 'Cheng', 'Affiliation': 'Hong Kong Cancer Fund, Hong Kong.'}, {'ForeName': 'Polly F M', 'Initials': 'PFM', 'LastName': 'Lim', 'Affiliation': 'Hong Kong Cancer Fund, Hong Kong.'}, {'ForeName': 'Sau-Fong', 'Initials': 'SF', 'LastName': 'Chow', 'Affiliation': 'Hong Kong Cancer Fund, Hong Kong.'}, {'ForeName': 'Cecilia L W', 'Initials': 'CLW', 'LastName': 'Chan', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Daniel F K', 'Initials': 'DFK', 'LastName': 'Wong', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1722981'] 786,31783823,Oral esketamine for treatment-resistant depression: rationale and design of a randomized controlled trial.,"BACKGROUND There is an urgent need to develop additional treatment strategies for patients with treatment-resistant depression (TRD). The rapid but short-lived antidepressant effects of intravenous (IV) ketamine as a racemic mixture have been shown repeatedly in this population, but there is still a paucity of data on the efficacy and safety of (a) different routes of administration, and (b) ketamine's enantiomers esketamine and arketamine. Given practical advantages of oral over IV administration and pharmacodynamic arguments for better antidepressant efficacy of esketamine over arketamine, we designed a study to investigate repeated administration of oral esketamine in patients with TRD. METHODS This study features a triple-blind randomized placebo-controlled trial (RCT) comparing daily oral esketamine versus placebo as add-on to regular antidepressant medications for a period of 6 weeks, succeeded by a follow-up of 4 weeks. The methods support examination of the efficacy, safety, tolerability, mechanisms of action, and economic impact of oral esketamine in patients with TRD. DISCUSSION This is the first RCT investigating repeated oral esketamine administration in patients with TRD. If shown to be effective and tolerated, oral esketamine administration poses important advantages over IV administration. TRIAL REGISTRATION Dutch Trial Register, NTR6161. Registered 21 October 2016.",2019,"This study features a triple-blind randomized placebo-controlled trial (RCT) comparing daily oral esketamine versus placebo as add-on to regular antidepressant medications for a period of 6 weeks, succeeded by a follow-up of 4 weeks.","['patients with TRD', 'patients with treatment-resistant depression (TRD']","['daily oral esketamine versus placebo', 'placebo', 'oral esketamine', 'Oral esketamine', 'intravenous (IV) ketamine']","['efficacy, safety, tolerability, mechanisms of action, and economic impact of oral esketamine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2825616'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524059', 'cui_str': 'mode of action'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2825616'}]",,0.312752,"This study features a triple-blind randomized placebo-controlled trial (RCT) comparing daily oral esketamine versus placebo as add-on to regular antidepressant medications for a period of 6 weeks, succeeded by a follow-up of 4 weeks.","[{'ForeName': 'Sanne Y', 'Initials': 'SY', 'LastName': 'Smith-Apeldoorn', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands. s.y.apeldoorn@umcg.nl.'}, {'ForeName': 'Jolien K E', 'Initials': 'JKE', 'LastName': 'Veraart', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Kamphuis', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Antoinette D I', 'Initials': 'ADI', 'LastName': 'van Asselt', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Aan Het Rot', 'Affiliation': 'Department of Psychology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schoevers', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2359-1'] 787,30146166,Monthly high-dose vitamin D3 supplementation and self-reported adverse events in a 4-year randomized controlled trial.,"BACKGROUND The use of high-dose vitamin D supplementation has increased in recent years. However, relatively little is known about the safety of long-term high doses. AIMS To investigate the safety of a monthly high-dose of vitamin D 3 supplementation taken for up to 4 years. METHODS Data were collected in a randomized, double blind, placebo-controlled trial of 5108 adults aged 50-84 years old from Auckland, New Zealand. Participants were given monthly doses of 100,000 IU vitamin D 3 or placebo, for a median of 3.3 years (range 2.5-4.2 years). They answered an open-ended question in a monthly questionnaire about any adverse events they attributed to the study capsules, which were coded blindly. Incidence rates per person months were calculated for categories of adverse events. Cox regression model used to calculate hazard ratio of time to first adverse-event. RESULTS In total, 419 (16.5%) participants taking vitamin D and 399 (15.8%) taking placebo reported ≥1 adverse event. Compared to placebo, the hazard ratio (HR) of reporting first adverse event in the vitamin D group was 1.03 (95% CI: 0.90, 1.18; p = 0.63). Despite a slightly higher incidence of recurrent adverse events in vitamin D arm, the incidence rate ratio (1.17) was not significantly higher in vitamin D (95% CI: 0.97, 1.41; p = 0.10). All regression results were adjusted for age, sex, and ethnicity. There was no difference between study arms in terms of participants' allocation perception (p = 0.52). CONCLUSION Monthly supplementation of 100,000 IU vitamin D3 for a median of 3.3 years did not affect participant-reported adverse events. TRIAL REGISTRATION clinicaltrials.gov Identifier: ACTRN12611000402943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12611000402943.",2019,"There was no difference between study arms in terms of participants' allocation perception (p = 0.52). ","['5108 adults aged 50-84 years old from Auckland, New Zealand']","['vitamin D supplementation', 'placebo', 'vitamin D 3 or placebo', 'vitamin D3 supplementation', 'vitamin D 3 supplementation', 'vitamin D3']","['incidence rate ratio', 'adverse event', ""participants' allocation perception"", 'hazard ratio (HR) of reporting first adverse event']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",5108.0,0.746346,"There was no difference between study arms in terms of participants' allocation perception (p = 0.52). ","[{'ForeName': 'Zarintaj', 'Initials': 'Z', 'LastName': 'Malihi', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of General Practice, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.07.034'] 788,30382806,Nutritional supplementation boosts aerobic exercise effects on functional brain systems.,"There is growing evidence that aerobic exercise protects against age-related cognitive decline and that cardiorespiratory fitness is an important factor for these benefits. Studies also suggest that combining physical activity with cognitive enrichment is beneficial. We further examine these predictions by comparing effects of a nutritional supplement promoting exercise capacity to a lower-intensity activity with cognitive enrichment on functional network and cognitive outcomes that otherwise decline with aging. Inactive healthy older adults were randomized to one of four groups including a low-intensity activity with complex cognitive demands (dancing), walking, walking+supplement, or an active control. Results showed that walking+supplement increased salience network functional connectivity (FC), with less training benefit for default mode network FC. Although cognitive performance did not increase for any training group, participants in the walking+supplement group who were on medication that boosted key neurotransmitters (e.g., selective serotonin reuptake inhibitors) showed improved processing speed. Overall, this study provides new insight into how to boost the protective effects of exercise on brain systems that otherwise deteriorate with aging. NEW & NOTEWORTHY Aerobic exercise effects on brain networks that otherwise decline with aging can be boosted with a nutritional supplement including beta-alanine. Beta-alanine supplementation could enhance the extent to which aerobic adaptations benefit the brain. In contrast, cognitive enrichment with low-intensity physical activity through dance did not affect functional networks. Medications that modulate neurotransmitters affected by aging (e.g., selective serotonin reuptake inhibitors) may modify effects of exercise on cognition.",2019,"Results showed that walking+supplement increased salience network functional connectivity (FC), with less training benefit for default mode network FC.",['Inactive healthy older adults'],"['Nutritional supplementation boosts aerobic exercise', 'nutritional supplement promoting exercise capacity', 'aerobic exercise', 'low-intensity activity with complex cognitive demands (dancing), walking, walking+supplement, or an active control', 'Beta-alanine supplementation']","['functional brain systems', 'processing speed', 'salience network functional connectivity (FC', 'cognitive performance']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}]",,0.0377968,"Results showed that walking+supplement increased salience network functional connectivity (FC), with less training benefit for default mode network FC.","[{'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Voss', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa , Iowa City, Iowa.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sutterer', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa , Iowa City, Iowa.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Weng', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa , Iowa City, Iowa.'}, {'ForeName': 'Agnieszka Z', 'Initials': 'AZ', 'LastName': 'Burzynska', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University , Fort Collins, Colorado.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign , Urbana, Illinois.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Salerno', 'Affiliation': 'Cancer Prevention Fellowship Program, Division of Cancer Prevention, National Cancer Institute , Bethesda, Maryland.'}, {'ForeName': 'Neha P', 'Initials': 'NP', 'LastName': 'Gothe', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign , Urbana, Illinois.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Ehlers', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign , Urbana, Illinois.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McAuley', 'Affiliation': 'The Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana-Champaign , Urbana, Illinois.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'The Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana-Champaign , Urbana, Illinois.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00917.2017'] 789,31606460,Pathological consequences of anti-citrullinated protein antibodies in tear fluid and therapeutic potential of pooled human immune globulin-eye drops in dry eye disease.,"PURPOSE To investigate the role of Anti-Citrullinated Protein autoantibodies (ACPAs) in the pathology of dry eye disease (DED) and the therapeutic potential of pooled human immune globulin-eye drops in these patients. METHODS We investigated the presence of citrullinated proteins and ACPAs in ocular surface wash (OSW) and conjunctival impressions from patients with DED and determined the pathological consequences of OSW with high ACPA using in vitro experiments and in vivo murine models. We performed a randomized, double-masked, pilot clinical trial to determine the safety, tolerability and preliminary efficacy of using pooled human immune globulin-eye drops to treat DED patients with ACPAs in OSW. RESULTS We found that neutrophils are a source of citrullinated proteins on the ocular surface of DED patients. We detected significantly higher immunoglobulin amount and presence of several species of ACPAs in OSW from DED patients. We also found that OSW with high ACPA contributes to production of NETs, and that ACPAs cause ocular surface disease in murine eyes, both of which are reduced with addition of Immune globulins. As compared to Vehicle treatment, pooled human immune globulin-eye drops (IVIG 4 mg/mL) twice a day for 8 weeks caused significant reduction in signs and symptoms of DED with no difference in tolerability or adverse events. CONCLUSIONS This is the first report demonstrating ACPAs in OSW of DED patients and their contribution to ocular surface disease. The first-in-human clinical trial suggests that pooled immune globulin-eye drops are a potential new class of biologic therapies for Dry Eye patients.",2020,We detected significantly higher immunoglobulin amount and presence of several species of ACPAs in OSW from DED patients.,"['Dry Eye patients', 'DED patients with ACPAs in OSW', 'pooled human immune globulin-eye drops in dry eye disease', 'patients with DED and determined the pathological consequences of OSW with high ACPA using in vitro experiments and in vivo murine models']","['pooled human immune globulin-eye drops', 'Anti-Citrullinated Protein autoantibodies (ACPAs']","['signs and symptoms of DED', 'safety, tolerability', 'tolerability or adverse events']","[{'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0253787', 'cui_str': 'acetyl-para-aminosalicylic acid'}]","[{'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0779988,We detected significantly higher immunoglobulin amount and presence of several species of ACPAs in OSW from DED patients.,"[{'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Bayasgalan', 'Initials': 'B', 'LastName': 'Surenkhuu', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Ilangovan', 'Initials': 'I', 'LastName': 'Raju', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Atassi', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mun', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Center for Clinical and Translational Science, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Monazzah Akbar', 'Initials': 'MA', 'LastName': 'Sarwar', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rosenblatt', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Anubhav', 'Initials': 'A', 'LastName': 'Pradeep', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Dhall', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mun', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Cornea Translational Biology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: jains@uic.edu.'}]",The ocular surface,['10.1016/j.jtos.2019.10.004'] 790,31056710,"Anxiety Sensitivity and Distress Tolerance in Smokers: Relations With Tobacco Dependence, Withdrawal, and Quitting Success†.","INTRODUCTION This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. METHODS Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of nicotine patch, nicotine patch plus nicotine lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. RESULTS DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus lozenge versus patch alone. CONCLUSIONS DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. IMPLICATIONS People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received nicotine patch plus nicotine lozenge rather than nicotine patch alone. TRIAL REGISTRATION NCT01553084.",2020,"DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at Week 4 with patch + lozenge versus patch alone. ","['Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African-American', 'Smokers with high distress tolerance', 'Smokers']","['nicotine patch plus nicotine lozenge rather than nicotine patch alone', 'nicotine patch, nicotine patch + nicotine lozenge, or varenicline']","['anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response', 'Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence', 'anxiety sensitivity, predicted abstinence', 'Anxiety Sensitivity and Distress Tolerance', 'anxiety, and anxiety disorder history']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C4517801', 'cui_str': '52.2 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1253423', 'cui_str': 'Nicotine Oral Lozenge'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]",,0.0745448,"DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at Week 4 with patch + lozenge versus patch alone. ","[{'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Stevens S', 'Initials': 'SS', 'LastName': 'Smith', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz070'] 791,30698272,Efficacy of ADAM Zolmitriptan for the Acute Treatment of Difficult-to-Treat Migraine Headaches.,"OBJECTIVE To understand the efficacy of zolmitriptan applied with Adhesive Dermally Applied Microarray (ADAM) in treating types of migraine (those with severe headache pain, the presence of nausea, treatment ≥2 hours after migraine onset, or migraine present upon awakening) that are historically considered to be less responsive to oral medications. BACKGROUND ADAM is an investigational system for intracutaneous drug administration. In a pivotal Phase 2b/3 study (ZOTRIP, N = 321 in the modified intention-to-treat population), ADAM zolmitriptan 3.8 mg provided superior pain freedom and freedom from patients' usual most bothersome associated symptom (MBS), compared with placebo at 2 hours post-dose. We undertook a post hoc analysis of data from the ZOTRIP trial to examine these same outcomes in subsets of patients whose migraine characteristics have been associated with poorer outcomes when treated with oral medications. METHODS The ZOTRIP trial was a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase 2b/3 study conducted at 36 sites in the United States. Presented here are post hoc subgroup analyses of patients with nausea (n = 110) or severe pain (n = 72) at baseline, those whose treatment was delayed 2 or more hours after onset (n = 75), and those who awoke with migraine (n = 80). The Cochran-Mantel-Haenszel test was used to assess whether patients in the ADAM zolmitriptan 3.8 mg group had superior treatment outcomes compared with placebo. RESULTS In patients with nausea, 2-hour pain freedom was achieved in 44% (26/59) in the ADAM zolmitriptan 3.8 mg group and 14% (7/51) in the placebo group (P = .005) (odds ratio = 5.11, 95% CI: 1.96-13.30), and 2-hour MBS freedom was achieved in 68% (40/59) in the active treatment group and 45% (23/51) of those receiving placebo (P = .009) (odds ratio = 2.86, 95% CI: 1.28-6.43). For those with severe pain, corresponding pain-free values were 26% (10/39) and 15% (5/33) (P = .249) (odds ratio = 2.14, 95% CI: 0.60-7.62), and MBS-free values were 64% (25/39) and 42% (14/33) (P = .038) (odds ratio = 2.86, 95% CI: 1.05-7.79). Among participants who awoke with migraine, 44% (16/36) and 16% (7/44) were pain-free in the ADAM zolmitriptan 3.8 mg and placebo groups, respectively (P = .006) (odds ratio = 4.29, 95% CI: 1.50-12.31), and 72% (26/36) vs 39% (17/44) were MBS-free, respectively (P = .003) (odds ratio = 4.40, 95% CI: 1.61-12.05). In those whose treatment was delayed ≥2 hours, pain freedom in the active treatment group and placebo group were 33% (12/36) and 10% (4/39), respectively (P = .017) (odds ratio = 4.33, 95% CI: 1.24-15.10), and MBS freedom was achieved in 69% (25/36) and 41% (16/39), respectively, in the delayed treatment group (P = .014) (odds ratio = 3.37, 95% CI: 1.27-8.95). No significant effects (overall interaction P = .353) were observed in logistical regression models of treatment by subgroup interaction. CONCLUSION Severe pain, delayed treatment, awakening with a headache, and the presence of nausea are factors that predict a poorer response to acute migraine treatment. In these post hoc analyses of subgroups of patients with each of these characteristics in the ZOTRIP trial, participants receiving ADAM zolmitriptan 3.8 mg displayed nearly uniformly better headache responses (2-hour headache freedom and 2-hour MBS freedom) compared with those who received placebo.",2019,"No significant effects (overall interaction P = .353) were observed in logistical regression models of treatment by subgroup interaction. ","['parallel group Phase 2b/3 study conducted at 36 sites in the United States', 'n\xa0=\xa075), and those who awoke with migraine (n\xa0=\xa080']","['ADAM zolmitriptan', 'placebo', 'Adhesive Dermally Applied Microarray (ADAM', 'zolmitriptan', 'ADAM Zolmitriptan']","['MBS-free', 'MBS freedom', 'pain-free values', '2-hour MBS freedom', 'nausea, 2-hour pain freedom', 'pain freedom', 'headache responses (2-hour headache freedom and 2-hour MBS freedom', 'severe pain', 'pain-free', 'nausea', 'MBS-free values']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0528166', 'cui_str': 'zolmitriptan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",,0.438609,"No significant effects (overall interaction P = .353) were observed in logistical regression models of treatment by subgroup interaction. ","[{'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, The Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Schmidt', 'Affiliation': 'Zosano Pharma, Fremont, CA, USA.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Kellerman', 'Affiliation': 'Zosano Pharma, Fremont, CA, USA.'}]",Headache,['10.1111/head.13482'] 792,32146698,Uptake of an exercise class and use of bone density measurement after advice by the health insurance fund: results from the osteoporotic fracture prevention program in rural areas (OFRA).,"BACKGROUND OFRA is a large health insurance fund-driven program which aims to reduce the risk of falls and fractures in older people living in rural areas. The programme offered specific mobility and falls prevention classes and bone density measurement by a DXA scan free of charge to more than 10,000 people, and was promoted by staff of the health insurance fund either by a visit at home, or a phone call, or a visit at home and a subsequent phone call. The aim of this study was to analyse the uptake of an exercise class and the use of a DXA scan after advice. METHODS Telephone interviews were conducted in a randomly selected subgroup of 780 persons 9 months after first contact. Rates of uptake of an exercise class or use of a DXA scan were calculated. Predictors of uptake and use were analysed applying logistic regression models. RESULTS The rate of uptake after advice for specific mobility and fall prevention class was 29.6%. For DXA scan, the rate of use after advice was 16.7%. Rates of uptake and use increased if the first contact by a visit at home or a phone call was followed by an additional subsequent phone call. CONCLUSION A direct motivational approach in older people by a health insurance fund is feasible and results in relevant participation and utilization rates in exercise classes and DXA scans.",2020,A direct motivational approach in older people by a health insurance fund is feasible and results in relevant participation and utilization rates in exercise classes and DXA scans.,"['Telephone interviews were conducted in a randomly selected subgroup of 780 persons 9\xa0months after first contact', 'older people living in rural areas', 'older people by a health insurance', 'rural areas (OFRA']",[],['rate of uptake after advice for specific mobility and fall prevention class'],"[{'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}]",[],"[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",,0.0419855,A direct motivational approach in older people by a health insurance fund is feasible and results in relevant participation and utilization rates in exercise classes and DXA scans.,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roigk', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Auerbachstraße 110, 70376, Stuttgart, Germany. Patrick.roigk@rbk.de.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Büchele', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rehm', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Auerbachstraße 110, 70376, Stuttgart, Germany.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Rapp', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Auerbachstraße 110, 70376, Stuttgart, Germany.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01506-2'] 793,31246117,Psycho-physiological response to pain among individuals with comorbid pain and opioid use disorder: Implications for patients with prolonged abstinence.,"Background : Individuals with comorbid opioid addiction and pain (COAP) relapse 3-5 times more often than patients with opioid use disorder (OUD) but without pain. However, psychophysiological responses to pain among a COAP population are unknown. Objectives : We hypothesized that those on Medications for Opioid Use Disorder (MOUD) with chronic pain, relative to opioid-naïve chronic pain individuals, would show greater psycho-physiological pain reactivity and slower recovery when exposed to acute pain. Methods : Four groups with chronic pain were recruited (N = 120; 60% Female): 1) MOUD-methadone; 2) MOUD-buprenorphine; 3) history of completed MOUD with prolonged opioid abstinence (PA; M abstinence = 121 weeks; SD = 23.3); and 4) opioid-naïve. We assessed heart rate (HR), galvanic skin conductance (GSC), peripheral temperature, and frontalis electromyography (EMG) during a cold pain task. Results : MOUD subjects had delayed HR reactivity to pain compared to those not on MOUD (PA & opioid-naïve; F(3,119) = 2.87, p < .04). The PA group showed a normal HR reactivity pattern, but had higher HR compared to the opioid-naïve group. The GSC group x time analysis showed the PA group had greater baseline levels and pain reactivity than the other groups (F(3,119) = 3.84, p < .02). The opioid-naïve group had lower reactivity on peripheral temperature compared to other groups (F(3,119) = 9.69, p < .001). Conclusion : Greater psychophysiological reactivity to pain was experienced by co-morbid OUD/chronic pain subjects who had been opioid abstinent for an extended period, possibly due to the lack of a buffering effect of opioid agonists. These subjects may develop coping skills to tolerate pain distress, thereby avoiding relapse in response to pain triggers. Understanding how pain creates more intense psychophysiological responses among COAP patients may lead to better treatments.",2019,"The opioid-naïve group had lower reactivity on peripheral temperature compared to other groups (F(3,119) = 9.69, p < .001). ","[' : Individuals with comorbid opioid addiction and pain', 'patients with prolonged abstinence', 'COAP patients', 'individuals with comorbid pain and opioid use disorder', 'Four groups with chronic pain were recruited (N = 120; 60% Female): 1) MOUD-methadone; 2) MOUD-buprenorphine; 3) history of completed MOUD with prolonged opioid abstinence (PA; M abstinence = 121 weeks; SD = 23.3); and 4) opioid-naïve']",[],"['heart rate (HR), galvanic skin conductance (GSC), peripheral temperature, and frontalis electromyography (EMG) during a cold pain task', 'baseline levels and pain reactivity', 'peripheral temperature', 'delayed HR reactivity to pain', 'normal HR reactivity pattern', 'psychophysiological reactivity to pain']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0687352,"The opioid-naïve group had lower reactivity on peripheral temperature compared to other groups (F(3,119) = 9.69, p < .001). ","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wachholtz', 'Affiliation': 'a Department of Psychology, University of Colorado Denver , Denver , CO , USA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Gonzalez', 'Affiliation': 'b Department of Psychiatry, University of Massachusetts Medical School , Worcester , MA , USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Ziedonis', 'Affiliation': 'b Department of Psychiatry, University of Massachusetts Medical School , Worcester , MA , USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1620260'] 794,31628954,Underwater versus conventional endoscopic resection of nondiminutive nonpedunculated colorectal lesions: a prospective randomized controlled trial (with video).,"BACKGROUND AND AIMS Incomplete resection of colorectal neoplasia decreases the efficacy of colonoscopy. Conventional resection (CR) of polyps, performed in a gas-distended colon, is the current standard, but incomplete resection rates of approximately 2% to 30% for nondiminutive (>5 mm), nonpedunculated lesions are reported. Underwater resection (UR) is a novel technique. The aim of this study was to determine the incomplete resection rates of colorectal lesions removed by UR versus CR. METHODS In a randomized controlled trial, patients with small (6-9 mm) and large (≥10 mm) nonpedunculated lesions were assigned to CR (gas-distended lumen) or UR (water-filled, gas-excluded lumen). Small lesions in both arms were removed with a dedicated cold snare. For CR, large lesions were removed with a hot snare after submucosal injection. For UR, large lesions were removed with a hot snare without submucosal injection. Four-quadrant biopsy samples around the resection sites were used to evaluate for incomplete resection. RESULTS Four hundred sixty-two eligible polyps (248 UR vs 214 CR) from 255 patients were removed. Incomplete resection rates for UR and CR were low and did not differ (2% vs 1.9%, P = .91). UR was performed significantly faster for lesions ≥10 mm in size (10-19 mm, 2.9 minutes vs 5.6 minutes, P < .0001); ≥20 mm, 7.3 minutes vs 9.5 minutes, P = .015). CONCLUSIONS Low incomplete resection rates are achievable with UR and CR. UR is effective and safe with the advantage of faster resection and potential cost savings for removal of larger (≥10 mm) lesions by avoiding submucosal injection. As an added approach, UR has potential to improve the cost-effectiveness of colonoscopy by increasing efficiency and reducing cost while maintaining quality. (Clinical trial registration number: NCT02889679.).",2020,"UR was performed significantly faster for lesions ≥10 mm in size (10-19 mm, 2.9 minutes vs 5.6 minutes, p<0.0001; ≥20 mm 7.3 minutes vs 9.5 minutes, p=0.015). ","['nondiminutive nonpedunculated colorectal lesions', 'patients with small (6-9 mm) and large (≥10 mm) nonpedunculated lesions were assigned to CR (gas-distended lumen) or UR (water-filled, gas-excluded lumen', 'Four hundred sixty-two eligible polyps (248 UR vs 214 CR) from 255 patients were removed']","['Underwater versus conventional endoscopic resection', 'Conventional resection (CR', 'Underwater resection (UR']","['Incomplete resection rates for UR and CR', 'incomplete resection rates of colorectal lesions']","[{'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",462.0,0.0761696,"UR was performed significantly faster for lesions ≥10 mm in size (10-19 mm, 2.9 minutes vs 5.6 minutes, p<0.0001; ≥20 mm 7.3 minutes vs 9.5 minutes, p=0.015). ","[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Yen', 'Affiliation': 'Sacramento Veterans Affairs Medical Center, VA Northern California Health Care System, Division of Gastroenterology, Mather, California, USA; University of California Davis School of Medicine, Sacramento, California, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leung', 'Affiliation': 'Sacramento Veterans Affairs Medical Center, VA Northern California Health Care System, Division of Gastroenterology, Mather, California, USA; University of California Davis School of Medicine, Sacramento, California, USA.'}, {'ForeName': 'Machelle D', 'Initials': 'MD', 'LastName': 'Wilson', 'Affiliation': 'Clinical and Translational Science Center, Department of Public Health Sciences, Division of Biostatistics, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Leung', 'Affiliation': 'Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System, Division of Gastroenterology, North Hills, California, USA; David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.09.039'] 795,32113625,Optimal Design of Population-Level Financial Incentives of Influenza Vaccination for the Elderly.,"OBJECTIVES To identify how monetary incentives affect influenza vaccination uptake rate using a randomized control experiment and to subsequently design an optimal incentive program in Singapore, a high-income country with a market-based healthcare system. METHODS 4000 people aged ≥65 were randomly assigned to 4 treatment groups (1000 each) and were offered a monetary incentive (in shopping vouchers) if they chose to participate. The baseline group was invited to complete a questionnaire with incentives of 10 Singapore dollars (SGD; where 1 SGD ≈ 0.73 USD), whereas the other three groups were invited to complete the questionnaire and be vaccinated against influenza at their own cost of around 32 SGD, in return for incentives of 10, 20, or 30 SGD. RESULTS Increasing the total incentive for vaccination and reporting from 10 to 20 SGD increased participation in vaccination from 4.5% to 7.5% (P < .001). Increasing the total incentive from 20 to 30 SGD increased the participation rate to 9.2%, but this was not statistically significantly different from a 20-SGD incentive. The group of nonworking elderly were more sensitive to changes in incentives than those who worked. In addition to working status, the effects of increasing incentives on influenza vaccination rates differed by ethnicity, socio-economic status, household size, and a measure of social resilience. There were no significant differential effects by age group, gender, or education, however. The cost of the program per completed vaccination under a 20-SGD incentive is 36.80 SGD, which was the lowest among the three intervention arms. For a hypothetical population-level financial incentive program to promote influenza vaccination among the elderly, accounting for transmission dynamics, an incentive between 10 and 20 SGD minimizes the cost per completed vaccination from both governmental and health system perspectives. CONCLUSIONS Appropriate monetary incentives can boost influenza vaccination rates. Increasing monetary incentives for vaccination from 10 to 20 SGD can improve the influenza vaccination uptake rate, but further increasing the monetary incentive to 30 SGD results in no additional gains. A partial incentive may therefore be considered to improve vaccination coverage in this high-risk group.",2020,"In addition to working status, the effects of increasing incentives on influenza vaccination rates differed by ethnicity, socio-economic status, household size, and a measure of social resilience.","['4000 people aged ≥65', 'Singapore, a high-income country with a market-based healthcare system']",['monetary incentive (in shopping vouchers'],"['influenza vaccination uptake rate', 'vaccination coverage', 'influenza vaccination rates', 'participation rate']","[{'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0150768', 'cui_str': 'Shopping (observable entity)'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}]",4000.0,0.0215498,"In addition to working status, the effects of increasing incentives on influenza vaccination rates differed by ethnicity, socio-economic status, household size, and a measure of social resilience.","[{'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Yue', 'Affiliation': 'School of Mathematical Sciences, University of Electronic Science and Technology of China, Chengdu, Sichuan, China; Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Chng Kiat', 'Initials': 'CK', 'LastName': 'Low', 'Affiliation': 'Department of Statistics and Applied Probability, National University of Singapore, Singapore.'}, {'ForeName': 'Joanne Su-Yin', 'Initials': 'JS', 'LastName': 'Yoong', 'Affiliation': 'Center for Economic and Social Research, University of Southern California, Los Angeles, CA, USA; Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Cook', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore; Department of Statistics and Applied Probability, National University of Singapore, Singapore; Duke-NUS Medical School Singapore, Singapore. Electronic address: alex.richard.cook@gmail.com.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.08.006'] 796,31263284,Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study.,"Metabolic syndrome is characterized by a constellation of comorbidities that predispose individuals to an increased risk of developing cardiovascular pathologies as well as type 2 diabetes mellitus 1 . The gut microbiota is a new key contributor involved in the onset of obesity-related disorders 2 . In humans, studies have provided evidence for a negative correlation between Akkermansia muciniphila abundance and overweight, obesity, untreated type 2 diabetes mellitus or hypertension 3-8 . Since the administration of A. muciniphila has never been investigated in humans, we conducted a randomized, double-blind, placebo-controlled pilot study in overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial. The primary end points were safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass). Secondary outcomes were gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition. In this single-center study, we demonstrated that daily oral supplementation of 10 10 A. muciniphila bacteria either live or pasteurized for three months was safe and well tolerated. Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02). Pasteurized A. muciniphila supplementation slightly decreased body weight (-2.27 ± 0.92 kg, P = 0.091) compared to the placebo group, and fat mass (-1.37 ± 0.82 kg, P = 0.092) and hip circumference (-2.63 ± 1.14 cm, P = 0.091) compared to baseline. After three months of supplementation, A. muciniphila reduced the levels of the relevant blood markers for liver dysfunction and inflammation while the overall gut microbiome structure was unaffected. In conclusion, this proof-of-concept study (clinical trial no. NCT02637115 ) shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.",2019,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","['overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial', 'overweight and obese human volunteers']","['placebo', 'Akkermansia muciniphila']","['safe and well tolerated', 'insulin sensitivity', 'reduced insulinemia', 'several metabolic parameters', 'body weight', 'fat mass', 'gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition', 'hip circumference', 'safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass', 'levels of the relevant blood markers for liver dysfunction and inflammation', 'plasma total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",40.0,0.293433,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Depommier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Everard', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Druart', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Plovier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Van Hul', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vieira-Silva', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Falony', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Barsy', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Loumaye', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Hermans', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Patrice.cani@uclouvain.be.'}]",Nature medicine,['10.1038/s41591-019-0495-2'] 797,30701596,Understanding adolescent and parent acceptability and feasibility experience in a large Type 1 diabetes mellitus behavioural trial.,"AIMS Using an 18-month, multisite randomized control trial as an exemplar, the aim of this study was to identify themes related to adolescent and parental feasibility and acceptability for participation in large behavioural trials designed to improve adolescents' Type 1 diabetes self-management. METHODS Thematic analysis methodology was used to develop themes describing factors related to acceptability and feasibility. RESULTS Based on a sample of interviews (N = 72), factors contributing to intervention acceptability and feasibility were identified. Aspects of acceptability included: a framework for goal-setting, the coach as a non-judgemental listener, perception of an ongoing benefit to participation and the delivery mode. Aspects of feasibility included: participants' altruism to help adolescents with Type 1 diabetes; pre-enrolment preparation for intervention content and duration; and the option of remote intervention delivery via telephone or video, which minimized travel time and costs. In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes. Participants also described potential revisions that may inform future trials. CONCLUSIONS Acceptability and feasibility of behavioural interventions with adolescents with chronic illness have multifactorial dimensions. While empowering adolescent self-management, parental support is also an under-appreciated aspect to consider. Potential revisions were identified for subsequent behavioural trials.",2020,"In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes.","[""adolescents' Type 1 diabetes self-management"", "" participants' altruism to help adolescents with Type 1 diabetes"", 'adolescents with chronic illness']",['behavioural interventions'],"['behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0002357', 'cui_str': 'Altruism'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]",[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0235187', 'cui_str': 'Attitude changed'}]",,0.0565679,"In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes.","[{'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Standiford', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Morwessel', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kichler', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'Division of Pediatric Endocrinology, Stanford University, Stanford, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Driscoll', 'Affiliation': ""Department of Pediatrics, Barbara Davis Center for Childhood Diabetes, The Children's Hospital of Colorado, Aurora, CO.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Seid', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13913'] 798,30674987,Effects of transcranial direct current stimulation on the cognitive control of negative stimuli in borderline personality disorder.,"Borderline personality disorder (BPD) is characterized by impairments in the cognitive control of negative information. These impairments in cognitive control are presumably due to blunted activity of the dorsolateral prefrontal cortex (dlPFC) along with enhanced activations of the limbic system. However, the impact of an excitatory stimulation of the dlPFC still needs to be elucidated. In the present study, we therefore assigned 50 patients with BPD and 50 healthy controls to receive either anodal or sham stimulation of the right dlPFC in a double-blind, randomized, between-subjects design. Participants performed a delayed working memory task with a distracter period during which a grey background screen, or neutral, or negative stimuli were presented. This experimental paradigm was first evaluated in a pilot study with 18 patients with BPD and 19 healthy controls. In both studies, patients with BPD showed an impairment of cognitive control when negative distracters were presented in the delay period of a working memory task. However, excitatory stimulation of the right dlPFC did not ameliorate cognitive control of negative stimuli in BPD, which raises questions about the specific role of the right dlPFC for the understanding of BPD psychopathology. Methodological limitations are discussed.",2019,"However, excitatory stimulation of the right dlPFC did not ameliorate cognitive control of negative stimuli in BPD, which raises questions about the specific role of the right dlPFC for the understanding of BPD psychopathology.","['borderline personality disorder', '50 patients with BPD and 50 healthy controls to receive either', 'Borderline personality disorder (BPD', '18 patients with BPD and 19 healthy controls']","['delayed working memory task with a distracter period during which a grey background screen, or neutral, or negative stimuli were presented', 'transcranial direct current stimulation', 'anodal or sham stimulation of the right dlPFC']",[],"[{'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]",[],50.0,0.0287266,"However, excitatory stimulation of the right dlPFC did not ameliorate cognitive control of negative stimuli in BPD, which raises questions about the specific role of the right dlPFC for the understanding of BPD psychopathology.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Clinical Psychology and Psychotherapy, Freie Universität Berlin, Berlin, Germany. lars.schulze@fu-berlin.de.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Grove', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Tamm', 'Affiliation': 'Experimental and Cognitive Neuropsychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Renneberg', 'Affiliation': 'Clinical Psychology and Psychotherapy, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Department of Psychiatry, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.'}]",Scientific reports,['10.1038/s41598-018-37315-x'] 799,30887470,The Clinical and Cost Effectiveness of Inotuzumab Ozogamicin for the Treatment of Adult Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia: An Evidence Review Group Evaluation of a NICE Single Technology Appraisal.,"The National Institute for Health and Care Excellence (NICE) invited Pfizer, the manufacturer of inotuzumab ozogamicin (henceforth inotuzumab), to submit clinical- and cost-effectiveness evidence for inotuzumab as part of NICE's single technology appraisal process. The Centre for Reviews and Dissemination and the Centre for Health Economics, both at the University of York, were commissioned as the independent evidence review group (ERG). The clinical-effectiveness data were from a multicentre randomised controlled trial that compared inotuzumab with standard of care (SoC), where SoC was the investigator's choice of chemotherapy. Inotuzumab demonstrated statistically significant improvements in response rates or in the proportion of patients progressing to haematopoietic stem cell transplant (HSCT) but failed to meet the second primary objective of longer overall survival. Treatment-emergent adverse events were more frequent in the SoC arm, except veno-occlusive disease, which was more frequent in the inotuzumab arm. The company's economic model split patients into three post-hoc subgroups and used a partitioned survival approach within each group, with a cure assumption 3 years after receiving HSCT. In contrast with the trial results, the economic model estimated substantial improvement in survival with inotuzumab compared with SoC, providing an additional 5.2 life-years and 2.2 quality-adjusted life-years (QALYs) using a discount rate of 1.5% per annum. The ERG's critique highlighted a number of concerns, including the use of a post-hoc post-randomisation patient subset for extrapolation, the choice of a 1.5% discount rate, the complexity of the parametric modelling, the assumption of further treatment benefit post-HSCT, the nature of the cure assumption, and the length of inpatient stay while receiving treatment. The combination of the ERG's adjustments resulted in an incremental cost-effectiveness ratio (ICER) of £122,174 per QALY gained using Kaplan-Meier survival estimates and £114,078 per QALY gained with parametric survival models fit to the trial data. The final determination of the appraisal followed four NICE Appraisal Committee meetings, an appeal by the company and other stakeholders, two patient access schemes, and a company response to each appraisal consultation. The final ICER post-consultation was between £33,749 and £37,497 per QALY gained compared with SoC (excluding the confidential discount for blinatumomab received as subsequent therapy). The Appraisal Committee concluded that the ICER for inotuzumab was within the range usually considered cost effective for end-of-life care and recommended inotuzumab within its licensed indication.",2019,"The final ICER post-consultation was between £33,749 and £37,497 per QALY gained compared with SoC (excluding the confidential discount for blinatumomab received as subsequent therapy).",['Adult Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia'],"['Inotuzumab Ozogamicin', 'inotuzumab with standard of care (SoC', 'HSCT']","['survival', 'response rates', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0006413', 'cui_str': 'Burkitt Cell Leukemia'}]","[{'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.052188,"The final ICER post-consultation was between £33,749 and £37,497 per QALY gained compared with SoC (excluding the confidential discount for blinatumomab received as subsequent therapy).","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Centre for Health Economics, University of York, York, YO10 5DD, UK. edward.cox@york.ac.uk.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Wade', 'Affiliation': 'Centre for Reviews and Dissemination (CRD), University of York, York, UK.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Peron', 'Affiliation': 'Centre for Health Economics, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Kristina Charlotte', 'Initials': 'KC', 'LastName': 'Dietz', 'Affiliation': 'Centre for Reviews and Dissemination (CRD), University of York, York, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Eastwood', 'Affiliation': 'Centre for Reviews and Dissemination (CRD), University of York, York, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'Centre for Health Economics, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'Centre for Health Economics, University of York, York, YO10 5DD, UK.'}]",PharmacoEconomics,['10.1007/s40273-019-00779-4'] 800,30660721,Model-based pain and function outcome trajectory types for patients undergoing knee arthroplasty: a secondary analysis from a randomized clinical trial.,"OBJECTIVE Knee arthroplasty (KA) is an effective surgical procedure. However, clinical studies suggest that a considerable number of patients continue to experience substantial pain and functional loss following surgical recovery. We aimed to estimate pain and function outcome trajectory types for persons undergoing KA, and to determine the relationship between pain and function trajectory types, and pre-surgery predictors of trajectory types. DESIGN Participants were 384 patients who took part in the KA Skills Training randomized clinical trial. Pain and function were assessed at 2-week pre- and 2-, 6-, and 12-months post-surgery. Piecewise latent class growth models were used to estimate pain and function trajectories. Pre-surgery variables were used to predict trajectory types. RESULTS There was strong evidence for two trajectory types, labeled as good and poor, for both Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores. Model estimated rates of the poor trajectory type were 18% for pain and function. Dumenci's latent kappa between pain and function trajectory types was 0.71 (95% CI: 0.61-0.80). Pain catastrophizing and number of painful body regions were significant predictors of poor pain and function outcomes. Outcome-specific predictors included low income for poor pain and baseline pain and younger age for poor function. CONCLUSIONS Among adults undergoing KA, approximately one-fifth continue to have persistent pain, poor function, or both. Although the poor pain and function trajectory types tend to go together within persons, a significant number experience either poor pain or function but not both, suggesting heterogeneity among persons who do not fully benefit from KA.",2019,"There was strong evidence for two trajectory types, labeled as good and poor, for both Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores.","['patients undergoing knee arthroplasty', 'persons undergoing KA', 'Participants were 384 patients who took part in the KA Skills Training randomized clinical trial']",['Knee arthroplasty (KA'],"['Pain catastrophizing and number of painful body regions', 'Pain and function', 'low income for poor pain and baseline pain and younger age for poor function', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005898', 'cui_str': 'Body Regions'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",384.0,0.047035,"There was strong evidence for two trajectory types, labeled as good and poor, for both Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dumenci', 'Affiliation': 'Department of Epidemiology and Biostatistics, 1301 Cecil B. Moore, Ave., Ritter Annex, Room 939, Temple University, Philadelphia, PA, USA. Electronic address: ldumenci@temple.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Perera', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Pain Prevention and Treatment Research, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Ang', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Slover', 'Affiliation': 'Department of Orthopaedic Surgery, New York University Longone Medical Center, New York, NY, USA.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Riddle', 'Affiliation': 'Departments of Physical Therapy, Orthopaedic Surgery and Rheumatology, Virginia Commonwealth University, Richmond, VA, USA.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.01.004'] 801,30508141,Feasibility of implementing mobile technology-delivered mental health treatment in routine adult sickle cell disease care.,"Sickle cell disease (SCD) is a severe hemoglobinopathy characterized by acute and chronic pain. Sufferers of the disease, most of whom are underrepresented minorities, are at increased risk for mental health disorders. The purpose of this study is to test the acceptability and implementation of a computerized cognitive behavioral therapy (cCBT) intervention, Beating the Blues, to improve depression, anxiety, and pain in patients with SCD. Adults with SCD and significant symptoms of depression (Patient Health Questionnaire [PHQ-9] score ≥ 10) or anxiety (Generalized Anxiety Disorder Scale [GAD-7] score ≥ 10) were eligible to participate and be randomized to either receive eight sessions of cCBT with care coach support or treatment as usual. Participants reported daily pain and mood symptoms using a mobile diary app. Depression, anxiety, and pain symptoms were assessed at 1, 3, and 6 months. Thirty patients were enrolled: 18 to cCBT, and 12 to control. The cCBT intervention was feasible to implement in clinical settings and acceptable to participants. Patients in the cCBT arm reported a marginally greater decrease in depression at 6 months (-3.82, SE = 1.30) than those in the control group (-0.50, SE = 1.60; p = .06). There were no significant effects of treatment on anxiety; however, cCBT was associated with improved daily pain reported via a mobile diary app (p = .014). cCBT, delivered via mobile device, is a feasible strategy to provide mental health care to adults living with SCD. cCBT was acceptable to the target population; was able to be implemented in real-world, nonideal conditions; and has the potential to improve patient-reported outcomes.",2020,"There were no significant effects of treatment on anxiety; however, cCBT was associated with improved daily pain reported via a mobile diary app (p = .014).","['Thirty patients were enrolled: 18 to cCBT, and 12 to control', 'patients with SCD', 'routine adult sickle cell disease care', 'adults living with SCD']","['computerized cognitive behavioral therapy (cCBT) intervention', 'cCBT intervention', 'implementing mobile technology-delivered mental health treatment', 'cCBT with care coach support or treatment as usual', 'cCBT']","['depression', 'Depression, anxiety, and pain symptoms', 'depression (Patient Health Questionnaire [PHQ-9] score ≥ 10) or anxiety', 'depression, anxiety, and pain', 'anxiety', 'daily pain', 'daily pain and mood symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",30.0,0.074803,"There were no significant effects of treatment on anxiety; however, cCBT was associated with improved daily pain reported via a mobile diary app (p = .014).","[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Jonassaint', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kemar V', 'Initials': 'KV', 'LastName': 'Prussien', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Yarboi', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Maureen S', 'Initials': 'MS', 'LastName': 'Sanger', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'J Deanna', 'Initials': 'JD', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Castro', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Nirmish', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'UCSF Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, University of California, San Francisco, CA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby107'] 802,30383540,An airway epithelial IL-17A response signature identifies a steroid-unresponsive COPD patient subgroup.,"BACKGROUND Chronic obstructive pulmonary disease (COPD) is a heterogeneous smoking-related disease characterized by airway obstruction and inflammation. This inflammation may persist even after smoking cessation and responds variably to corticosteroids. Personalizing treatment to biologically similar ""molecular phenotypes"" may improve therapeutic efficacy in COPD. IL-17A is involved in neutrophilic inflammation and corticosteroid resistance, and thus may be particularly important in a COPD molecular phenotype. METHODS We generated a gene expression signature of IL-17A response in bronchial airway epithelial brushings from smokers with and without COPD (n = 238), and validated it using data from 2 randomized trials of IL-17 blockade in psoriasis. This IL-17 signature was related to clinical and pathologic characteristics in 2 additional human studies of COPD: (a) SPIROMICS (n = 47), which included former and current smokers with COPD, and (b) GLUCOLD (n = 79), in which COPD participants were randomized to placebo or corticosteroids. RESULTS The IL-17 signature was associated with an inflammatory profile characteristic of an IL-17 response, including increased airway neutrophils and macrophages. In SPIROMICS the signature was associated with increased airway obstruction and functional small airways disease on quantitative chest CT. In GLUCOLD the signature was associated with decreased response to corticosteroids, irrespective of airway eosinophilic or type 2 inflammation. CONCLUSION These data suggest that a gene signature of IL-17 airway epithelial response distinguishes a biologically, radiographically, and clinically distinct COPD subgroup that may benefit from personalized therapy. TRIAL REGISTRATION ClinicalTrials.gov NCT01969344. FUNDING Primary support from the NIH, grants K23HL123778, K12HL11999, U19AI077439, DK072517, U01HL137880, K24HL137013 and R01HL121774 and contracts HHSN268200900013C, HHSN268200900014C, HHSN268200900015C, HHSN268200900016C, HHSN268200900017C, HHSN268200900018C, HHSN268200900019C and HHSN268200900020C.",2019,"The IL-17 signature was associated with an inflammatory profile characteristic of an IL-17 response, including increased airway neutrophils and macrophages.","['2 additional human studies of COPD: (a) SPIROMICS (n = 47), which included former and current smokers with COPD, and (b) GLUCOLD (n = 79), in which COPD participants', 'bronchial airway epithelial brushings from smokers with and without COPD (n = 238', 'Chronic obstructive pulmonary disease (COPD']","['IL-17 blockade', 'IL-17A', 'placebo or corticosteroids']","['airway obstruction and functional small airways disease', 'response to corticosteroids, irrespective of airway eosinophilic or type 2 inflammation']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3241966'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",238.0,0.244491,"The IL-17 signature was associated with an inflammatory profile characteristic of an IL-17 response, including increased airway neutrophils and macrophages.","[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Christenson', 'Affiliation': 'Department of Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'University Medical Center Groningen, Department of Pulmonary Diseases and Research Institute for Asthma and COPD (GRIAC), Groningen, Netherlands.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'University Medical Center Groningen, Department of Pulmonary Diseases and Research Institute for Asthma and COPD (GRIAC), Groningen, Netherlands.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Inkamp', 'Affiliation': 'University Medical Center Groningen, Department of Pulmonary Diseases and Research Institute for Asthma and COPD (GRIAC), Groningen, Netherlands.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Bhakta', 'Affiliation': 'Department of Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Luke R', 'Initials': 'LR', 'LastName': 'Bonser', 'Affiliation': 'Department of Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Lorna T', 'Initials': 'LT', 'LastName': 'Zlock', 'Affiliation': 'Department of Pathology, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Igor Z', 'Initials': 'IZ', 'LastName': 'Barjaktarevic', 'Affiliation': 'Department of Medicine, UCLA, Los Angeles, California, USA.'}, {'ForeName': 'R Graham', 'Initials': 'RG', 'LastName': 'Barr', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Boucher', 'Affiliation': 'Marsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Bowler', 'Affiliation': 'National Jewish Health, Denver, Colorado, USA.'}, {'ForeName': 'Alejandro P', 'Initials': 'AP', 'LastName': 'Comellas', 'Affiliation': 'Department of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Curtis', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Hansel', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Pieter S', 'Initials': 'PS', 'LastName': 'Hiemstra', 'Affiliation': 'Department of Pulmonology, University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kaner', 'Affiliation': 'Department of Medicine, Weill Cornell Medical Center, New York, New York, USA.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnanm', 'Affiliation': 'Breathe Chicago Center, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Medicine, Weill Cornell Medical Center, New York, New York, USA.'}, {'ForeName': 'Wanda K', 'Initials': 'WK', 'LastName': ""O'Neal"", 'Affiliation': 'Marsico Lung Institute, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paine', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Timens', 'Affiliation': 'University Medical Center Groningen, Department of Pathology and Medical Biology and Research Institute for Asthma and COPD (GRIAC), Groningen, Netherlands.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Avrum', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Erle', 'Affiliation': 'Department of Medicine, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Prescott G', 'Initials': 'PG', 'LastName': 'Woodruff', 'Affiliation': 'Department of Medicine, UCSF, San Francisco, California, USA.'}]",The Journal of clinical investigation,['10.1172/JCI121087'] 803,30389894,Identification of patients who will not achieve seizure remission within 5 years on AEDs.,"OBJECTIVE To identify people with epilepsy who will not achieve a 12-month seizure remission within 5 years of starting treatment. METHODS The Standard and New Antiepileptic Drug (SANAD) study is the largest prospective study in patients with epilepsy to date. We applied a recently developed multivariable approach to the SANAD dataset that takes into account not only baseline covariates describing a patient's history before diagnosis but also follow-up data as predictor variables. RESULTS Changes in number of seizures and treatment history were the most informative time-dependent predictors and were associated with history of neurologic insult, epilepsy type, age at start of treatment, sex, and having a first-degree relative with epilepsy. Our model classified 95% of patients. Of those classified, 95% of patients observed not to achieve remission at 5 years were correctly classified (95% confidence interval [CI] 89.5%-100%), with 51% identified by 3 years and 90% within 4 years of follow-up. Ninety-seven percent (95% CI 93.3%-98.8%) of patients observed to achieve a remission within 5 years were correctly classified. Of those predicted not to achieve remission, 76% (95% CI 58.5%-88.2%) truly did not achieve remission (positive predictive value). The predictive model achieved similar accuracy levels via external validation in 2 independent United Kingdom-based datasets. CONCLUSION Our approach generates up-to-date predictions of the patient's risk of not achieving seizure remission whenever new clinical information becomes available that could influence patient counseling and management decisions.",2018,"Of those predicted not to achieve remission, 76% (95% CI 58.5%-88.2%) truly did not achieve remission (positive predictive value).","['people with epilepsy who will not achieve a 12-month seizure remission within 5 years of starting treatment', 'patients with epilepsy to date']",[],['seizure remission'],"[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]",[],"[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0566354,"Of those predicted not to achieve remission, 76% (95% CI 58.5%-88.2%) truly did not achieve remission (positive predictive value).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hughes', 'Affiliation': 'From the Departments of Biostatistics (D.M.H., L.J.B., G.C., M.G.-F.) and Molecular and Clinical Pharmacology (A.G.M.), Institute of Translational Medicine, and Department of Eye and Vision Science (G.C.), Institute of Ageing & Chronic Disease, University of Liverpool, UK; and Department of Probability and Mathematical Statistics (A.K.), Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bonnett', 'Affiliation': 'From the Departments of Biostatistics (D.M.H., L.J.B., G.C., M.G.-F.) and Molecular and Clinical Pharmacology (A.G.M.), Institute of Translational Medicine, and Department of Eye and Vision Science (G.C.), Institute of Ageing & Chronic Disease, University of Liverpool, UK; and Department of Probability and Mathematical Statistics (A.K.), Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Czanner', 'Affiliation': 'From the Departments of Biostatistics (D.M.H., L.J.B., G.C., M.G.-F.) and Molecular and Clinical Pharmacology (A.G.M.), Institute of Translational Medicine, and Department of Eye and Vision Science (G.C.), Institute of Ageing & Chronic Disease, University of Liverpool, UK; and Department of Probability and Mathematical Statistics (A.K.), Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Arnošt', 'Initials': 'A', 'LastName': 'Komárek', 'Affiliation': 'From the Departments of Biostatistics (D.M.H., L.J.B., G.C., M.G.-F.) and Molecular and Clinical Pharmacology (A.G.M.), Institute of Translational Medicine, and Department of Eye and Vision Science (G.C.), Institute of Ageing & Chronic Disease, University of Liverpool, UK; and Department of Probability and Mathematical Statistics (A.K.), Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Marson', 'Affiliation': 'From the Departments of Biostatistics (D.M.H., L.J.B., G.C., M.G.-F.) and Molecular and Clinical Pharmacology (A.G.M.), Institute of Translational Medicine, and Department of Eye and Vision Science (G.C.), Institute of Ageing & Chronic Disease, University of Liverpool, UK; and Department of Probability and Mathematical Statistics (A.K.), Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'From the Departments of Biostatistics (D.M.H., L.J.B., G.C., M.G.-F.) and Molecular and Clinical Pharmacology (A.G.M.), Institute of Translational Medicine, and Department of Eye and Vision Science (G.C.), Institute of Ageing & Chronic Disease, University of Liverpool, UK; and Department of Probability and Mathematical Statistics (A.K.), Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic. martaf@liv.ac.uk.'}]",Neurology,['10.1212/WNL.0000000000006564'] 804,31975479,Implementation of a flexible visiting policy in intensive care unit: A randomized clinical trial.,"BACKGROUND Visitation is one of the most critical needs of patients in intensive care units (ICUs). Clinicians should enable a more flexible visitation policy to prevent the adverse effects of a restricted approach. AIM AND OBJECTIVES This study aimed at investigating the relationship between increasing visitation time and patients' physiological parameters in intensive units. Additionally, nurses' beliefs and attitudes towards visiting is examined in this research. DESIGN Parallel randomized clinical trial. METHODS This study was conducted in four general medical ICUs in Iran. In total, 60 patients and 57 nurses participated in this study. The patients' physiological parameters were measured at particular times in both groups. Moreover, the nurses responded to the questionnaire on beliefs and attitudes towards visitation in intensive units before and after the intervention. RESULTS Among all the physiological parameters, systolic and diastolic blood pressure and heart rate had a significant decrease within the normal range 10 and 30 minutes after visiting in the intervention group (P < .05), and nurses' beliefs and attitudes score were at the middle of the survey scoring range (0-120). However, no significant difference was found between nurses' belief and attitude score and intervention in any groups (P > .05). CONCLUSION The findings indicate that increasing visitation times can lead to a positive effect on the stability and balance of patients' physiological parameters. RELEVANCE TO CLINICAL PRACTICE A more flexible visiting policy can provide a therapeutic environment where not only patients' physiological disorders are minimised as much as possible but also a higher level of patients' health and satisfaction are reached.",2020,"However, no significant difference found between nurses' belief and attitude score and intervention in any groups (P > .05). CONCLUSION ","['Totally 60 patients and 57 nurses participated in this study', 'four general medical ICUs in Iran', 'patients in intensive care units (ICUs']",[],"['systolic and diastolic blood pressure and heart rate', ""nurses' belief and attitude score and intervention"", ""stability and balance of patients' physiological indices""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.057715,"However, no significant difference found between nurses' belief and attitude score and intervention in any groups (P > .05). CONCLUSION ","[{'ForeName': 'Reihane', 'Initials': 'R', 'LastName': 'Akbari', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Karimi Moonaghi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mazloum', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Bagheri Moghaddam', 'Affiliation': 'Internal Medicine and Critical Care, Faculty of Medicine, Mashhad University of Medical Science, Mashhad, Iran.'}]",Nursing in critical care,['10.1111/nicc.12499'] 805,30476335,The search for the ejecting chair: a mixed-methods analysis of tool use in a sedentary behavior intervention.,"Research is needed on interventions targeting sedentary behavior with appropriate behavior-change tools. The current study used convergent sequential mixed methods (QUAN + qual) to explore tool use during a edentary behavior intervention. Data came from a two-arm randomized sedentary behavior pilot intervention. Participants used a number of intervention tools (e.g., prompts and standing desks). Separate mixed-effects regression models explored associations between change in number of tools and frequency of tool use with two intervention targets: change in sitting time and number of sit-to-stand transitions overtime. Qualitative data explored participants' attitudes towards intervention tools. There was a significant relationship between change in total tool use and sitting time after adjusting for number of tools (β = -12.86, p = .02), demonstrating that a one-unit increase in tool use was associated with an almost 13 min reduction in sitting time. In contrast, there was a significant positive association between change in number of tools and sitting time after adjusting for frequency of tool use (β = 63.70, p = .001), indicating that increasing the number of tools without increasing frequency of tool use was associated with more sitting time. Twenty-four semistructured interviews were coded and a thematic analysis revealed four themes related to tool use: (a) prompts to disrupt behavior; (b) tools matching the goal; (c) tools for sit-to-stand were ineffective; and (d) tool use evolved over time. Participants who honed in on effective tools were more successful in reducing sitting time. Tools for participants to increase sit-to-stand transitions were largely ineffective. This study is registered at clincialtrials.gov. Identifier: NCT02544867.",2020,"There was a significant relationship between change in total tool use and sitting time after adjusting for number of tools (β = -12.86, p = .02), demonstrating that a one-unit increase in tool use was associated with an almost 13 min reduction in sitting time.",[],[],"['number of tools and sitting time', 'sitting time', 'successful in reducing sitting time', 'total tool use and sitting time', 'sitting time and number of sit-to-stand transitions overtime']",[],[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C2961731', 'cui_str': 'Overtime'}]",,0.0337136,"There was a significant relationship between change in total tool use and sitting time after adjusting for number of tools (β = -12.86, p = .02), demonstrating that a one-unit increase in tool use was associated with an almost 13 min reduction in sitting time.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Godbole', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Nebeker', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Madanat', 'Affiliation': 'Graduate School of Public Health, San Diego State University (SDSU), San Diego, CA, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'Department of Family Medicine and Public Health (FMPH), University of California, San Diego (UCSD), La Jolla, CA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby106'] 806,31978436,Perioperative prophylactic internal iliac artery balloon occlusion in the prevention of postpartum hemorrhage in placenta previa: a randomized controlled trial.,"BACKGROUND Placenta previa remains one of the major causes of massive postpartum hemorrhage and maternal mortality worldwide. OBJECTIVE To determine whether internal iliac artery balloon occlusion during cesarean delivery for placenta previa could reduce postpartum hemorrhage and other maternal complications. STUDY DESIGN This was a prospective randomized controlled trial conducted at a tertiary university obstetric unit in Hong Kong. Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2 cm from the internal os) and required cesarean delivery were invited to participate. Eligible pregnant women were randomized into internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group. Those randomized to the Occlusion group had internal iliac artery balloon catheter placement performed before cesarean delivery and then balloon inflation after delivery of the baby. The primary outcome was the reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion. Secondary outcome measures included hemoglobin drop after delivery; amount of blood product transfusion; incidence of hysterectomy; maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, and adult respiratory distress syndrome; length of stay in hospital; admission to intensive care unit; and maternal death. RESULTS Between May 2016 and September 2018, 40 women were randomized (20 in each group). Demographic and obstetric characteristics were similar between the 2 groups. In the Occlusion group, 3 women did not receive the scheduled procedure, as it was preceded by antepartum hemorrhage that required emergency cesarean delivery, and 1 woman had repeated scan at 36 weeks showing the placental edge was slightly more than 2 cm from the internal os. Intention-to-treat analysis found no significant differences between the Occlusion and the Control groups regarding to the median intraoperative blood loss (1451 [1024-2388] mL vs 1454 [888-2300] mL; P = .945), the median length of surgery (49 [30-62] min vs 37 [30-51] min; P = .204), or the need for blood transfusion during operation (57.9% vs 50.0%; P = .621). None of the patients had rebleeding after operation, complication related to internal iliac artery procedure, or any other maternal complications. Reanalyzing the data using on-treatment approach showed the same results. CONCLUSION The use of prophylactic internal iliac artery balloon occlusion in placenta previa patients undergoing cesarean delivery did not reduce postpartum hemorrhage or have any effect on maternal or neonatal morbidity.",2020,"None of the patients had rebleeding after operation, complication related to internal iliac artery procedure or any other maternal complications.","['ml vs 1454 (888-2300', 'tertiary university obstetric unit in Hong Kong', 'Eligible pregnant women', 'postpartum hemorrhage in placenta previa', 'Between May 2016 and Sep 2018, 40 women', 'placenta previa patients undergoing Cesarean delivery', 'Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2cm from the internal os) and required Cesarean delivery were invited to participate']","['Occlusion Group had internal iliac artery balloon catheter placement', 'internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group', 'internal iliac artery balloon occlusion', 'prophylactic internal iliac artery balloon occlusion', 'Perioperative prophylactic internal iliac artery balloon occlusion']","['hemoglobin drop after delivery, amount of blood product transfusion, incidence of hysterectomy, maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, adult respiratory distress syndrome, length of stay in hospital, admission to intensive care unit, and maternal death', 'median length of surgery', 'median intra-operative blood loss', 'reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion', 'postpartum hemorrhage', 'Demographic and obstetric characteristics', 'need for blood transfusion']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0227842', 'cui_str': 'Structure of internal os'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0012739', 'cui_str': 'Consumption Coagulopathy'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",40.0,0.221838,"None of the patients had rebleeding after operation, complication related to internal iliac artery procedure or any other maternal complications.","[{'ForeName': 'Simon Chun Ho', 'Initials': 'SCH', 'LastName': 'Yu', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Yvonne Kwun Yue', 'Initials': 'YKY', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Wing Ting', 'Initials': 'WT', 'LastName': 'Tse', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Daljit Singh', 'Initials': 'DS', 'LastName': 'Sahota', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Man Yan', 'Initials': 'MY', 'LastName': 'Chung', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Simon Sin Man', 'Initials': 'SSM', 'LastName': 'Wong', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Oi Ka', 'Initials': 'OK', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Tak Yeung', 'Initials': 'TY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong. Electronic address: tyleung@cuhk.edu.hk.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.024'] 807,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5'] 808,30085292,Effects of Intranasal Oxytocin on Stress-Induced Cigarette Craving in Daily Smokers.,"BACKGROUND Cigarette smoking is a well-known public health concern, and there is an urgent need to develop new treatments to reduce smoking or facilitate abstinence. One factor that is known to contribute to relapse is stress, making the stress response an important target for treatment. The neuropeptide oxytocin (OT) is believed to have stress-reducing effects, and in addition there is evidence that it reduces drug craving. The purpose of the present study was to examine the effects of intranasal OT on stress-induced cigarette craving in regular smokers after 12 h of abstinence. METHOD Daily smokers (n = 48) completed a stress induction task and a nonstressful control task at two different sessions, receiving intranasal OT (40 IU) or placebo (PBO) before or after the task. Subjects were randomly assigned to one of three groups: Group PP (n = 16) received PBO before and after the stress/control tasks, Group OP (n = 16) received OT before the tasks and PBO after, and Group PO (n = 16) received PBO before the tasks and OT shortly after completing the tasks. Cigarette craving as well as subjective and physiological responses to stress was assessed. RESULTS OT did not alter responses to stress, whether it was administered before or after the stressful task, on measures of cigarette craving, anxiety, heart rate, blood pressure, and cortisol levels. CONCLUSIONS The current study findings do not support several previous reports that OT reduced either stress or drug craving. IMPLICATIONS This study finds a null result of the neuropeptide oxytocin on stress-induced cigarette craving. Reporting null findings is part of the process of identifying potential treatments for addictive disorders.",2020,"Results OT did not alter responses to stress, whether it was administered before or after the stressful task, on measures of cigarette craving, anxiety, heart rate, blood pressure, and cortisol levels. ","['daily smokers', 'regular smokers after 12 hours of abstinence']","['neuropeptide oxytocin (OT', 'neuropeptide oxytocin', 'intranasal oxytocin', 'stress induction task and a non-stressful control task at two different sessions, receiving intranasal OT (40 IU) or placebo (PBO']","['stress-induced cigarette craving', 'Cigarette craving', 'cigarette craving, anxiety, heart rate, blood pressure, and cortisol levels']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0220557,"Results OT did not alter responses to stress, whether it was administered before or after the stressful task, on measures of cigarette craving, anxiety, heart rate, blood pressure, and cortisol levels. ","[{'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL.'}, {'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty159'] 809,32144531,Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial.,"PURPOSE Pilonidal sinus disease (PD) is a common acquired disease, responsible for discomfort and time off work. There is currently no consensus on the best surgical therapy. We aimed at comparing conservative sinusectomy (S) to excision and paramedian primary closure (PC). METHODS This is a randomized controlled trial compatible with the CONSORT statement standards. We included all patients with chronic PD between 2012 and 2017. We excluded patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps. Patients with chronic symptomatic PD were randomized to S or PC. Primary end-point was the rate of patients healed at 3 weeks, secondary outcomes were total healing time, pain, time off work, patient satisfaction and recurrence at 1 year. Patients were seen at a wound clinic until healed and contacted at 3, 6, and 12 months for follow-up. RESULTS After inclusion of 58 patients the study was stopped prematurely due to discrepancy between expected and observed outcomes. Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01). Median time to complete healing was 54 (23-328) days in the S group compared to 34 (13-141) in the PC group (p = 0.025). Number of outpatient visits, time off work, analgesia requirement, and recurrence rates at 12 months 4 (16%) in the S group and 3 (11.1%) in the PC group (p = 0.548) were similar. CONCLUSIONS PC leads to faster healing compared to S, with similar healthcare burden. TRIAL REGISTRATION The study was approved by the local ethics committee and registered in www.clinicaltrials.gov (REF: NCT03271996). The study was carried out at the Regional Hospital of Lugano, Switzerland.",2020,Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01).,"['patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps', 'patients with chronic PD between 2012 and 2017', 'pilonidal disease', 'Patients with chronic symptomatic PD']","['Conservative Sinusectomy vs. excision and primary off-midline closure', 'conservative sinusectomy (S) to excision and paramedian primary closure (PC']","['total healing time, pain, time off work, patient satisfaction and recurrence at 1\xa0year', 'Median time to complete healing', 'Number of outpatient visits, time off work, analgesia requirement, and recurrence rates', 'rate of patients healed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001304', 'cui_str': 'Acute abscess (morphologic abnormality)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C4544575', 'cui_str': 'Rotation flap (substance)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2317114', 'cui_str': 'Pilonidal disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0585074', 'cui_str': 'Amount of time off work'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]",,0.118992,Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01).,"[{'ForeName': 'Sotirios Georgios', 'Initials': 'SG', 'LastName': 'Popeskou', 'Affiliation': 'Department of Visceral Surgery and Transplantation, Geneva University Hospitals, Geneva, Switzerland. salvator10@yahoo.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pravini', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Panteleimonitis', 'Affiliation': 'School of Health Sciences and social work, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Antoniacopo Ferrario Di Tor', 'Initials': 'AFDT', 'LastName': 'Vajana', 'Affiliation': 'Department of Surgery, Regional Hospital of Bellinzona, Bellinzona, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vanoni', 'Affiliation': 'Department of Visceral Surgery, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Schmalzbauer', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Posabella', 'Affiliation': 'Department of Surgery, Standort Unispital Clarunis, Universitäres Bauchzentrum Basel, Basel, Switzerland.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Christoforidis', 'Affiliation': 'Department of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}]",International journal of colorectal disease,['10.1007/s00384-020-03551-9'] 810,30531234,Safety and Efficacy of Lofexidine for Medically Managed Opioid Withdrawal: A Randomized Controlled Clinical Trial.,"OBJECTIVES To investigate the safety and efficacy of lofexidine for treating opioid withdrawal syndrome (OWS) and facilitating completion of opioid withdrawal. METHODS A multicenter, double-blind, placebo-controlled study was conducted at 18 US centers from June 2013 to December 2014. Participants (n = 603) aged ≥18 years, dependent on short-acting opioids, and seeking withdrawal treatment, randomized 3:3:2 to receive lofexidine 2.88 mg/d (n = 222), lofexidine 2.16 mg/d (n = 230), or placebo (n = 151) for 7 days. Primary outcome was the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) scores rating withdrawal symptoms over days 1 to 7. RESULTS Participants were of mean age, 35 years; 71% male. Pairwise differences in overall SOWS-Gossop log-transformed least squares means were statistically significant for lofexidine 2.16 mg (difference, -0.21; 95% CI, -0.37 to -0.04; P = 0.02) and 2.88 mg (-0.26; 95% CI, -0.44 to -0.09; P = 0.003) compared with placebo. Fewer than half of participants in both groups completed the study. Completion rates for lofexidine 2.16 mg (41.5%; odds ratio [OR], 1.85; P = 0.007) and 2.88 mg (39.6%; OR, 1.71; P = 0.02) were significantly better compared with placebo (27.8%). Overall adverse event (AE) rates were similar across groups. Common AEs for lofexidine included orthostatic hypotension, hypotension, and bradycardia, but resulted in few study discontinuations. CONCLUSIONS Lofexidine 2.16 mg and 2.88 mg significantly reduced symptoms of OWS versus placebo, and increased absolute rates of completing the 7-day study by 14% and 12%, respectively (a relative increase of 85% and 71%). Data suggest that lofexidine is a generally safe and effective nonopioid treatment for opioid withdrawal. Lofexidine could serve as a withdrawal treatment option when a nonopioid agent is preferred or required, when agonist-assisted withdrawal is unavailable, when agonist discontinuation caused OWS, and during induction into maintenance treatment with opioid agonists or antagonists. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01863186.",2019,"Completion rates for lofexidine 2.16 mg (41.5%; odds ratio [OR], 1.85; P = 0.007) and 2.88 mg (39.6%; OR, 1.71; P = 0.02) were significantly better compared with placebo (27.8%).","['Participants (n\u200a', '603) aged ≥18 years, dependent on short-acting opioids, and seeking withdrawal treatment', '18 US centers from June 2013 to December 2014', 'Participants were of mean age, 35 years; 71% male', 'Medically Managed Opioid Withdrawal']","['lofexidine', 'placebo', 'Lofexidine']","['safety and efficacy', 'Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) scores rating withdrawal symptoms', 'orthostatic hypotension, hypotension, and bradycardia', 'absolute rates', 'Safety and Efficacy', 'Overall adverse event (AE) rates', 'Completion rates', 'overall SOWS-Gossop log-transformed least squares means', 'symptoms of OWS']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}]","[{'cui': 'C0065152', 'cui_str': 'lofexidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.706331,"Completion rates for lofexidine 2.16 mg (41.5%; odds ratio [OR], 1.85; P = 0.007) and 2.88 mg (39.6%; OR, 1.71; P = 0.02) were significantly better compared with placebo (27.8%).","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Department of Psychiatry, Johns Hopkins School of Medicine and Maryland Treatment Centers, Baltimore, MD (MF); CARMA Health, PLLC, Austin, TX (CT); Northwestern Medicine Central DuPage Hospital, Winfield, IL (DA); Pharmaceutical Development and Regulatory Affairs, US WorldMeds, LLC, Louisville, KY (KG); Biometrics, US WorldMeds, LLC, Louisville, KY (TC); Consultant to US WorldMeds, LLC, Louisville, KY (CWG).'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tirado', 'Affiliation': ''}, {'ForeName': 'Danesh', 'Initials': 'D', 'LastName': 'Alam', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Gullo', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clinch', 'Affiliation': ''}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Gorodetzky', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000474'] 811,30552176,"Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis.","OBJECTIVE To assess the efficacy, safety, pharmacokinetics and pharmacodynamics of the anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA). METHODS Patients with ≥1 erosive and ≥3 tender and/or swollen hand joints were randomised to placebo or lutikizumab 200 mg subcutaneously every 2 weeks for 24 weeks. The primary endpoint was change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score from baseline to 16 weeks. At baseline and week 26, subjects had bilateral hand radiographs and MRI of the hand with the greatest number of baseline tender and/or swollen joints. Continuous endpoints were assessed using analysis of covariance models, with treatment and country as main factors and baseline measurements as covariates. RESULTS Of 132 randomised subjects, 1 received no study drug and 110 completed the study (placebo, 61/67 (91%); lutikizumab, 49/64 (77%)). AUSCAN pain was not different among subjects treated with lutikizumab versus placebo at week 16 (least squares mean difference, 1.5 (95% CI -1.9 to 5.0)). Other clinical and imaging endpoints were not different between lutikizumab and placebo. Lutikizumab significantly decreased serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils. Lutikizumab pharmacokinetics were consistent with phase I studies and not affected by antidrug antibodies. Injection site reactions and neutropaenia were more common in the lutikizumab group; discontinuations because of adverse events occurred more frequently with lutikizumab (4/64) versus placebo (1/67). CONCLUSION Despite adequate blockade of IL-1, lutikizumab did not improve pain or imaging outcomes in erosive HOA compared with placebo.",2019,"Lutikizumab significantly decreased serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils.","['patients with erosive hand osteoarthritis', 'erosive hand osteoarthritis (HOA', 'Patients with ≥1 erosive and ≥3 tender and/or swollen hand joints', '132 randomised subjects']","['placebo', 'IL-1, lutikizumab', 'lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin', 'lutikizumab', 'Lutikizumab', 'lutikizumab versus placebo', 'anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981', 'placebo or lutikizumab']","['pain or imaging outcomes', 'serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils', 'adverse events', 'AUSCAN pain', 'efficacy, safety, pharmacokinetics and pharmacodynamics', 'change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score', 'Injection site reactions and neutropaenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439679', 'cui_str': 'Erosive (qualifier value)'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand (disorder)'}, {'cui': 'C0649652', 'cui_str': 'Benzenamine, 4-(hexyloxy)-'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0575805', 'cui_str': 'Swelling of hand'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}]",,0.624882,"Lutikizumab significantly decreased serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils.","[{'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Kloppenburg', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands g.kloppenburg@lumc.nl.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peterfy', 'Affiliation': 'Spire Sciences, Boca Raton, Florida, USA.'}, {'ForeName': 'Ida K', 'Initials': 'IK', 'LastName': 'Haugen', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Féline', 'Initials': 'F', 'LastName': 'Kroon', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Data and Statistical Sciences, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Development Design Center, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Levy', 'Affiliation': 'Pharmacovigilance and Patient Safety, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center at Dallas, Metroplex Clinical Research Center, Dallas, Texas, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Department of Rheumatology, Sorbonne Universités and Inserm, DHU i2B, APHP, Hospital Saint-Antoine, Paris, France.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'Scientific and Medical Services, PAREXEL, Waltham, Massachusetts, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wittoek', 'Affiliation': 'Department of Rheumatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Exploratory Statistics, Data Science and Statistics, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Yuni', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Drug Metabolism, Pharmacokinetics and Bioanalysis, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Saltarelli', 'Affiliation': 'Drug Metabolism, Pharmacokinetics and Bioanalysis, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Jeroen K', 'Initials': 'JK', 'LastName': 'Medema', 'Affiliation': 'Immunology Development, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Levesque', 'Affiliation': 'Immunology Development, AbbVie, North Chicago, Illinois, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2018-213336'] 812,29325171,"Maternal and Child Health Handbook use for maternal and child care: a cluster randomized controlled study in rural Java, Indonesia.","BACKGROUND Effectiveness of the Maternal and Child Health Handbook (MCHHB), a home-based booklet for pregnancy, delivery and postnatal/child health, was evaluated on care acquisition and home care in rural Java, a low service-coverage area. METHODS We conducted a health centre-based randomized trial, with a 2-year follow-up. Intervention included (i) MCHHB provision at antenatal care visits; (ii) records and guides by health personnel on and with the MCHHB; and (iii) sensitization of care by volunteers using the MCHHB. RESULTS The follow-up rate was 70.2% (183, intervention area; 271, control area). Respondents in the intervention area received consecutive MCH services including two doses of tetanus toxoid injections and antenatal care four times or more during pregnancy, professional assistance during child delivery and vitamin A supplements administration to their children, after adjustment for confounding variables and cluster effects (OR = 2.03, 95% CI: 1.19-3.47). In the intervention area, home care (continued breastfeeding; introducing complementary feeding; proper feeding order; varied foods feeding; self-feeding training; and care for cough), perceived support by husbands, and lower underweight rates and stunting rates among children were observed. CONCLUSION MCHHB use promoted continuous care acquisition and care at home from pregnancy to early child-rearing stages in rural Java.",2019,"BACKGROUND Effectiveness of the Maternal and Child Health Handbook (MCHHB), a home-based booklet for pregnancy, delivery and postnatal/child health, was evaluated on care acquisition and home care in rural Java, a low service-coverage area. ",[],"['Maternal and Child Health Handbook (MCHHB', 'MCHHB provision at antenatal care visits; (ii) records and guides by health personnel on and with the MCHHB; and (iii) sensitization of care by volunteers using the MCHHB', 'MCHHB', 'tetanus toxoid injections and antenatal care four times or more during pregnancy, professional assistance during child delivery and vitamin A supplements']",[],[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C3661611', 'cui_str': 'Vitamin A supplement'}]",[],,0.0346133,"BACKGROUND Effectiveness of the Maternal and Child Health Handbook (MCHHB), a home-based booklet for pregnancy, delivery and postnatal/child health, was evaluated on care acquisition and home care in rural Java, a low service-coverage area. ","[{'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Osaki', 'Affiliation': 'Japan International Cooperation Agency, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Hattori', 'Affiliation': 'Japan International Cooperation Agency, Jakarta, Indonesia.'}, {'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Toda', 'Affiliation': 'Japan International Cooperation Agency, Jakarta, Indonesia.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Mulati', 'Affiliation': 'Directorate of Medical Device and Household Product Inspection, Ministry of Health, Jakarta, Indonesia.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hermawan', 'Affiliation': 'Directorate of Family Health, Ministry of Health, Jakarta, Indonesia.'}, {'ForeName': 'Kirana', 'Initials': 'K', 'LastName': 'Pritasari', 'Affiliation': 'Agency for Development and Empowerment of Human Resources for Health, Ministry of Health, Jakarta, Indonesia.'}, {'ForeName': 'Saptawati', 'Initials': 'S', 'LastName': 'Bardosono', 'Affiliation': 'Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Soewarta', 'Initials': 'S', 'LastName': 'Kosen', 'Affiliation': 'Indonesia Agency for Health Research and Development, Ministry of Health, Jakarta, Indonesia.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdx175'] 813,30137242,Lower Pretreatment Gut Integrity Is Independently Associated With Fat Gain on Antiretroviral Therapy.,"BACKGROUND Fat accumulation and insulin resistance remain a threat to the success of antiretroviral therapy (ART). The role of gut dysfunction in metabolic complications associated with ART initiation is unclear. METHODS Human immunodeficiency virus (HIV)-infected ART-naive participants were randomized to tenofovir disoproxil fumarate/emtricitabine plus atazanavir/ritonavir, darunavir/ritonavir, or raltegravir (RAL). Changes in the gut integrity markers zonulin, lipopolysaccharide-binding protein (LBP), and intestinal fatty acid and ileal bile acid binding proteins (I-FABP and I-BABP) were assessed over 96 weeks. Wilcoxon rank-sum tests were used to compare changes between groups and linear regression models to quantify associations between gut markers, insulin resistance, body mass index (BMI), and visceral, subcutaneous, and total adipose tissue (VAT, SAT, and TAT). RESULTS : 90% were male and 48% were White non-Hispanic. The median age was 36 years, HIV-1 ribonucleic acid was 4.56 log10 copies/mL, and CD4 count was 338 cells/µL. An overall 1.7-fold increase in I-FABP was observed throughout 96 weeks, with no difference between arms. Zonulin levels increased with RAL compared to protease inhibitor-based regimens (week 96, P = .02); minimal changes in I-BABP or LBP levels were observed. Higher baseline I-FABP levels were associated with increases in VAT, TAT, and BMI (16%, 9%, and 2.5%, respectively; P < .04) over 96 weeks. CONCLUSIONS While ART induces changes in the markers of gut barrier dysfunction, the extent to which they improve or worsen the gut barrier function remains unclear. Nevertheless, markers of gut barrier dysfunction in ART-naive individuals predict increases in total and visceral abdominal fat with treatment initiation.",2019,"Zonulin levels increased with RAL compared to protease inhibitor-based regimens (week 96, P = .02); minimal changes in I-BABP or LBP levels were observed.","['Human immunodeficiency virus (HIV)-infected ART-naive participants', ' 90% were male and 48% were White non-Hispanic']","['tenofovir disoproxil fumarate/emtricitabine plus atazanavir/ritonavir, darunavir/ritonavir, or raltegravir (RAL']","['gut integrity markers zonulin, lipopolysaccharide-binding protein (LBP), and intestinal fatty acid and ileal bile acid binding proteins (I-FABP and I-BABP', 'total and visceral abdominal fat', 'I-FABP', 'Zonulin levels', 'minimal changes in I-BABP or LBP levels', 'Higher baseline I-FABP levels', 'gut markers, insulin resistance, body mass index (BMI), and visceral, subcutaneous, and total adipose tissue (VAT, SAT, and TAT', 'VAT, TAT, and BMI']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}]","[{'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0053579', 'cui_str': 'bile salt-binding proteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}]",,0.0480811,"Zonulin levels increased with RAL compared to protease inhibitor-based regimens (week 96, P = .02); minimal changes in I-BABP or LBP levels were observed.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'El Kamari', 'Affiliation': 'Case Western Reserve University, Ohio.'}, {'ForeName': 'Carlee', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Corrilynn O', 'Initials': 'CO', 'LastName': 'Hileman', 'Affiliation': 'Case Western Reserve University, Ohio.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'University of California Los Angeles.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Hunt', 'Affiliation': 'University of California San Francisco.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': 'Case Western Reserve University, Ohio.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy716'] 814,31976336,Impact of Short-Term Continuous and Interval Exercise Training on Endothelial Function and Glucose Metabolism in Prediabetes.,"Introduction The impact of interval (INT) vs. continuous (CONT) exercise training on endothelial function in relation to glucose metabolism prior to clinically meaningful weight loss is unknown in adults with prediabetes. Methods Twenty-six subjects with prediabetes (60 ± 1 y; 33 ± 1 kg/m 2 ; 2-hr-PG OGTT: 145 ± 7 mg/dl) were randomized to 60 min of CONT ( n = 12; 70% of HR peak ) or work-matched INT exercise training ( n = 14; alternating 3 min at 90 and 50% HR peak ) for 2 weeks. Aerobic fitness (VO 2peak ) and body composition (bioelectrical impedance) were assessed before and after training. Flow-mediated dilation (FMD) was measured during a 2 h 75 g OGTT (0, 60, and 120 min) to assess endothelial function. Postprandial FMD was calculated as incremental area under the curve (iAUC). Glucose tolerance and insulin were also calculated by iAUC. Fasting plasma VCAM, ICAM, and hs-CRP were also assessed as indicators of vascular/systemic inflammation. Results Both interventions increased VO 2peak ( P = 0.002) but had no effect on body fat ( P = 0.20). Although both treatments improved glucose tolerance ( P = 0.06) and insulin iAUC ( P = 0.02), VCAM increased ( P = 0.01). There was no effect of either treatment on ICAM, hs-CRP, or fasting as well as postprandial FMD. However, 57% of people improved fasting and iAUC FMD following CONT compared with only 42% after INT exercise (each: P = 0.04). Elevated VCAM was linked to blunted fasting FMD after training ( r = -0.38, P = 0.05). But, there was no correlation between fasting FMD or postprandial FMD with glucose tolerance ( r = 0.17, P = 0.39 and r = 0.02, P = 0.90, respectively) or insulin iAUC following training ( r = 0.34, P = 0.08 and r = 0.04, P = 0.83, respectively). Conclusion Endothelial function is not improved consistently after short-term training, despite improvements in glucose and insulin responses to the OGTT in obese adults with prediabetes.",2019,"Although both treatments improved glucose tolerance ( P = 0.06) and insulin iAUC ( P = 0.02), VCAM increased ( P = 0.01).","['obese adults with prediabetes', 'Methods\n\n\nTwenty-six subjects with prediabetes (60 ± 1 y; 33 ± 1 kg/m 2 ; 2-hr-PG OGTT: 145 ± 7 mg/dl', 'Prediabetes', 'adults with prediabetes']","['Short-Term Continuous and Interval Exercise Training', 'interval (INT) vs. continuous (CONT) exercise training', 'CONT', 'HR peak ) or work-matched INT exercise training']","['ICAM, hs-CRP, or fasting as well as postprandial FMD', 'blunted fasting FMD', 'Endothelial Function and Glucose Metabolism', 'Aerobic fitness (VO 2peak ) and body composition (bioelectrical impedance', 'insulin iAUC', 'body fat', 'fasting FMD or postprandial FMD with glucose tolerance', 'glucose tolerance', 'VCAM', 'glucose and insulin responses', 'endothelial function', 'Glucose tolerance and insulin', 'Postprandial FMD', 'fasting and iAUC FMD', 'Fasting plasma VCAM, ICAM, and hs-CRP', 'Elevated VCAM', 'VO 2peak', 'Flow-mediated dilation (FMD']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",26.0,0.0447675,"Although both treatments improved glucose tolerance ( P = 0.06) and insulin iAUC ( P = 0.02), VCAM increased ( P = 0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}]",Journal of diabetes research,['10.1155/2019/4912174'] 815,31926328,Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus.,"BACKGROUND In the new era of minimally invasive surgery, recent studies encouraged the adoption of endoscopic approaches as the most effective way to treat (pilonidal sinus disease) PSD but little is known about long-term results of minimally invasive procedures. MATERIALS AND METHODS A total of 145 patients with chronic non recurrent pilonidal sinus were enrolled for this randomized controlled trial. The follow-up rate was 97% at 5 years for a total of 74 patients assigned to the minimally invasive treatment group and 67 patients assigned to the conventional Bascom cleft lift treatment group. We evaluated the following outcomes: long-term recurrence rate, patients' satisfaction, cosmetic outcome and cost-effectiveness results. RESULTS Long-term data confirm that the recurrence rate was similar in both groups and, in minimally invasive patients, there were a higher satisfaction and better cosmetic results. Costs analysis revealed improved outcome in favour of VAAPS with a much lower mean global cost. CONCLUSION Minimally invasive treatment has all the characteristics of an ideal approach to PSD with advantages including minimal patient inconveniences, high satisfaction and good aesthetics results. It was also more cost effective to carry out the treatment.",2020,The follow-up rate was 97% at 5 years for a total of 74 patients assigned to the minimally invasive treatment group and 67 patients assigned to the conventional Bascom cleft lift treatment group.,"['pilonidal sinus', '145 patients with chronic non recurrent pilonidal sinus']","['endoscopic', 'conventional Bascom cleft lift treatment group']","[""recurrence rate, patients' satisfaction, cosmetic outcome and cost-effectiveness results"", 'cost effective', 'mean global cost', 'recurrence rate']","[{'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",145.0,0.0375773,The follow-up rate was 97% at 5 years for a total of 74 patients assigned to the minimally invasive treatment group and 67 patients assigned to the conventional Bascom cleft lift treatment group.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Milone', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy. Electronic address: milone.marco.md@gmail.com.'}, {'ForeName': 'Nunzio', 'Initials': 'N', 'LastName': 'Velotti', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Manigrasso', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vertaldi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Di Lauro', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Simone', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Cirillo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Maione', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gennarelli', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Loredana Maria', 'Initials': 'LM', 'LastName': 'Sosa Fernandez', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2019.12.033'] 816,31974806,Evaluation of a Falls and Fire Safety Program for Community-Dwelling Older Adults.,"Remembering When™ (RW) is a falls and fire prevention program delivered by fire service personnel and homecare organizations to help older adults live safely at home for as long as possible. This study evaluated changes in falls prevention and fire safety behaviors and perceptions and social support associated with falls and residential fires among older adults following delivery of the RW program by fire service personnel. In a convenience sample of adults 65 + years residing in five Iowa communities, 70 received the RW program during a home visit and 75 received the RW program in a group presentation followed by a home visit. Baseline and follow-up telephone interviews were conducted to assess changes in falls and fire safety behaviors, perceptions and social support. Changes were assessed using McNemar's exact test and paired sample t-tests. To control for dependence of 26 households with two participants, one participant was randomly selected and included in the analysis (n = 119). The RW program improved falls and residential fire prevention behaviors among older adults. Perceived efficacy to prevent falls increased from baseline (p = 0.047). Perceived susceptibility (p = 0.021) and control of fires (p = 0.000) increased while perceived severity (p = 0.025) and fear of residential fires (p = 0.019) decreased when compared to baseline. The proportion of participants reporting discussing falls with friends and family increased (p < 0.001), and more participants reported discussing fire prevention with healthcare professionals (p = 0.039). Fire service personnel can be effective deliverers of falls prevention information to older adults.",2020,"Baseline and follow-up telephone interviews were conducted to assess changes in falls and fire safety behaviors, perceptions and social support.","['Community-Dwelling Older Adults', '26 households with two participants, one participant was randomly selected and included in the analysis (n\u2009=\u2009119', 'adults 65 +\u2009years residing in five Iowa communities, 70 received the RW program during a home visit and 75 received the', 'older adults following delivery of the RW program by fire service personnel', 'older adults']","['RW program', 'Remembering When™ (RW', 'Falls and Fire Safety Program']","['control of fires', 'Perceived susceptibility', 'falls and residential fire prevention behaviors', 'changes in falls and fire safety behaviors, perceptions and social support', 'fear of residential fires']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",26.0,0.0335914,"Baseline and follow-up telephone interviews were conducted to assess changes in falls and fire safety behaviors, perceptions and social support.","[{'ForeName': 'Carri', 'Initials': 'C', 'LastName': 'Casteel', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, 145 N. Riverside Drive CPHB S314, Iowa City, IA, 52242, USA. carri-casteel@uiowa.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bruening', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, 145 N. Riverside Drive CPHB S314, Iowa City, IA, 52242, USA.'}, {'ForeName': 'McKyla', 'Initials': 'M', 'LastName': 'Carson', 'Affiliation': 'Department of Community and Behavioral Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Berard-Reed', 'Affiliation': 'National Fire Protection Association, Quincy, MA, USA.'}, {'ForeName': 'Sato', 'Initials': 'S', 'LastName': 'Ashida', 'Affiliation': 'Department of Community and Behavioral Health, University of Iowa, Iowa City, IA, USA.'}]",Journal of community health,['10.1007/s10900-019-00786-8'] 817,31268872,Allopurinol treatment adversely impacts left ventricular mass regression in patients with well-controlled hypertension.,"OBJECTIVES Previous studies have demonstrated that high-dose allopurinol is able to regress left ventricular (LV) mass in cohorts with established cardiovascular disease. The aim of this study was to assess whether treatment with high-dose allopurinol would regress LV mass in a cohort with essential hypertension, LV hypertrophy and well-controlled blood pressure but without established cardiovascular disease. METHODS We conducted a mechanistic proof-of-concept randomized, placebo-controlled, double-blind trial of allopurinol (600 mg/day) versus placebo on LV mass regression. Duration of treatment was 12 months. LV mass regression was assessed by Cardiac Magnetic Resonance. Secondary outcomes were changes in endothelial function (flow-mediated dilatation), arterial stiffness (pulse wave velocity) and biomarkers of oxidative stress. RESULTS Seventy-two patients were randomized into the trial. Mean baseline urate was 362.2 ± 96.7 μmol/l. Despite good blood pressure control, LV mass regression was significantly reduced in the allopurinol cohort compared with placebo (LV mass -0.37 ± 6.08 versus -3.75 ± 3.89 g; P = 0.012). Oxidative stress markers (thiobarbituric acid reactive substances) were significantly higher in the allopurinol group versus placebo (0.26 ± 0.85 versus -0.34 ± 0.83 μmol/l; P = 0.007). Other markers of vascular function were not significantly different between the two groups. CONCLUSION Treatment with high-dose allopurinol in normouricemic controlled hypertensive patients and LV hypertrophy is detrimental. It results in reduced LV mass regression and increased oxidative stress over a 12-month period. This may be because of an adverse impact on redox balance. Cohort selection for future cardiovascular trials with allopurinol is crucial.",2019,Oxidative stress markers (thiobarbituric acid reactive substances) were significantly higher in the allopurinol group versus placebo (0.26 ± 0.85 versus -0.34 ± 0.83 μmol/l; P = 0.007).,"['normouricemic controlled hypertensive patients', 'patients with well-controlled hypertension', 'Seventy-two patients']","['Allopurinol', 'allopurinol', 'placebo']","['oxidative stress', 'blood pressure control, LV mass regression', 'vascular function', 'changes in endothelial function (flow-mediated dilatation), arterial stiffness (pulse wave velocity) and biomarkers of oxidative stress', 'Oxidative stress markers (thiobarbituric acid reactive substances']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}]",72.0,0.657091,Oxidative stress markers (thiobarbituric acid reactive substances) were significantly higher in the allopurinol group versus placebo (0.26 ± 0.85 versus -0.34 ± 0.83 μmol/l; P = 0.007).,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gingles', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Symon', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Gandy', 'Affiliation': 'Department of Clinical Radiology.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Houston', 'Affiliation': 'Department of Clinical Radiology.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'MEMO and Hypertension Research Centre, University of Dundee, Dundee, UK.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Population Health Sciences Division.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee.'}]",Journal of hypertension,['10.1097/HJH.0000000000002189'] 818,31956660,Cod-Liver Oil Improves Metabolic Indices and hs-CRP Levels in Gestational Diabetes Mellitus Patients: A Double-Blind Randomized Controlled Trial.,"Objective To investigate the effects of cod-liver oil on metabolic status and high-sensitivity C-reactive protein (hs-CRP) in patients with gestational diabetes mellitus (GDM). Methods This study was a randomized, double-blinded, placebo-controlled trial with the allocation ratio of 1 : 1. The contents of EPA and DHA in cod-liver oil were measured using a gas chromatograph. A total of 550 GDM patients were randomly divided into the intervention group (cod-liver oil) and the control group (placebo, mineral oil), and both groups were given regular dietary care. Glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hour plasma glucose (2hPG), lipid profiles, homeostatic model assessment insulin resistance (HOMA-IR), and hs-CRP were measured. Primary outcomes were different in HbA1c, FPG, 2hPG, and HOMA-IR between the two groups after 4-week randomization. Secondary outcomes were the blood glucose levels and perinatal complications (pregnancy-induced hypertension, polyhydramnios, premature delivery, postpartum hemorrhage, postpartum infection, premature rupture of membranes, and cesarean section) between the two groups before and after 12-16 weeks of cod-liver oil intervention from middle pregnancy to late pregnancy. Results EPA and DHA were the main components of cod-liver oil with 76 mg/mL and 150 mg/mL, respectively. There was no significant difference for primary outcomes in the levels of HbA1c, FPG, 2hPG, HOMA-IR, and lipid profiles between the two groups ( P > 0.05). For the secondary outcomes, the levels of HbA1c, FPG, 2hPG, triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol ratio (LDL-C), HOMA-IR, and hs-CRP in the intervention group were significantly lower than those in the control group ( P < 0.05). The incidence of perinatal complications in the intervention group was lower than that in the control group too ( P < 0.05). Conclusions Cod-liver oil consumption effectively reduced the levels of blood glucose, lipid levels, hs-CRP, and HOMA-IR and the incidence of perinatal complications.",2019,"There was no significant difference for primary outcomes in the levels of HbA1c, FPG, 2hPG, HOMA-IR, and lipid profiles between the two groups ( P > 0.05).","['patients with gestational diabetes mellitus (GDM', '550 GDM patients', 'Gestational Diabetes Mellitus Patients']","['placebo', 'Cod-Liver Oil', 'intervention group (cod-liver oil) and the control group (placebo, mineral oil), and both groups were given regular dietary care', 'cod-liver oil intervention', 'cod-liver oil']","['contents of EPA and DHA in cod-liver oil', 'HbA1c, FPG, 2hPG, and HOMA-IR', 'Glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose (FPG', 'levels of HbA1c, FPG, 2hPG, triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol ratio (LDL-C), HOMA-IR, and hs-CRP', 'blood glucose levels and perinatal complications (pregnancy-induced hypertension, polyhydramnios, premature delivery, postpartum hemorrhage, postpartum infection, premature rupture of membranes, and cesarean section', 'incidence of perinatal complications', 'levels of HbA1c, FPG, 2hPG, HOMA-IR, and lipid profiles', 'levels of blood glucose, lipid levels, hs-CRP, and HOMA-IR and the incidence of perinatal complications', '2-hour plasma glucose (2hPG), lipid profiles, homeostatic model assessment insulin resistance (HOMA-IR), and hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009213', 'cui_str': 'Cod Liver Oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026156', 'cui_str': 'liquid paraffin'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0009213', 'cui_str': 'Cod Liver Oil'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0020224', 'cui_str': 'Hydramnios'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",,0.119203,"There was no significant difference for primary outcomes in the levels of HbA1c, FPG, 2hPG, HOMA-IR, and lipid profiles between the two groups ( P > 0.05).","[{'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China.'}, {'ForeName': 'Ruixin', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, The Second Hospital of Jilin University, Changchun 130041, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Jian', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130041, China.'}]",Journal of diabetes research,['10.1155/2019/7074042'] 819,31584222,Exercise increases caudate dopamine release and ventral striatal activation in Parkinson's disease.,"BACKGROUND The objective of this study was to examine the effects of aerobic exercise on evoked dopamine release and activity of the ventral striatum using positron emission tomography and functional magnetic resonance imaging in Parkinson's disease (PD). METHODS Thirty-five participants were randomly allocated to a 36-session aerobic exercise or control intervention. Each participant underwent an functional magnetic resonance imaging scan while playing a reward task before and after the intervention to determine the effect of exercise on the activity of the ventral striatum in anticipation of reward. A subset of participants (n = 25) completed [ 11 C] raclopride positron emission tomography scans to determine the effect of aerobic exercise on repetitive transcranial magnetic stimulation-evoked release of endogenous dopamine in the dorsal striatum. All participants completed motor (MDS-UPDRS part III, finger tapping, Timed-up-and-go) and nonmotor assessments (Starkstein Apathy Scale, Beck Depression Inventory, reaction time, Positive and Negative Affect Schedule, Trail Making Test [A and B], and Montreal Cognitive Assessment) before and after the interventions. RESULTS The aerobic group exhibited increased activity in the ventral striatum during functional magnetic resonance imaging in anticipation of 75% probability of reward (P = 0.01). The aerobic group also demonstrated increased repetitive transcranial magnetic stimulation-evoked dopamine release in the caudate nucleus (P = 0.04) and increased baseline nondisplaceable binding potential in the posterior putamen of the less affected repetitive transcranial magnetic stimulation-stimulated hemisphere measured by position emission tomography (P = 0.03). CONCLUSIONS Aerobic exercise alters the responsivity of the ventral striatum, likely related to changes to the mesolimbic dopaminergic pathway, and increases evoked dopamine release in the caudate nucleus. This suggests that the therapeutic benefits of exercise are in part related to corticostriatal plasticity and enhanced dopamine release. © 2019 International Parkinson and Movement Disorder Society.",2019,The aerobic group exhibited increased activity in the ventral striatum during functional magnetic resonance imaging in anticipation of 75% probability of reward (P = 0.01).,"['Thirty-five participants', ""Parkinson's disease"", ""Parkinson's disease (PD""]","['positron emission tomography and functional magnetic resonance imaging', 'functional magnetic resonance imaging scan while playing a reward task', '36-session aerobic exercise or control intervention', 'Aerobic exercise', 'aerobic exercise']","['motor (MDS-UPDRS part III, finger tapping, Timed-up-and-go) and nonmotor assessments (Starkstein Apathy Scale, Beck Depression Inventory, reaction time, Positive and Negative Affect Schedule, Trail Making Test', 'repetitive transcranial magnetic stimulation-evoked dopamine release', 'activity']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441633'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",35.0,0.101,The aerobic group exhibited increased activity in the ventral striatum during functional magnetic resonance imaging in anticipation of 75% probability of reward (P = 0.01).,"[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Sacheli', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Neva', 'Affiliation': 'Department of Physical Therapy, Brain Behaviour Laboratory, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bimal', 'Initials': 'B', 'LastName': 'Lakhani', 'Affiliation': 'Department of Physical Therapy, Brain Behaviour Laboratory, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Murray', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Vafai', 'Affiliation': 'Department of Physics and Astronomy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shahinfard', 'Affiliation': 'Department of Physics and Astronomy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'English', 'Affiliation': 'Department of Physics and Astronomy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McCormick', 'Affiliation': 'Department of Physics and Astronomy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Dinelle', 'Affiliation': 'Department of Physics and Astronomy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Neilson', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jessamyn', 'Initials': 'J', 'LastName': 'McKenzie', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schulzer', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Don C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Appel-Cresswell', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'McKeown', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Boyd', 'Affiliation': 'Department of Physical Therapy, Brain Behaviour Laboratory, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Sossi', 'Affiliation': 'Department of Physics and Astronomy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A Jon', 'Initials': 'AJ', 'LastName': 'Stoessl', 'Affiliation': ""Pacific Parkinson's Research Centre, Djavad Mowafaghian Centre for Brain Health, University of British Columbia & Vancouver Coastal Health, Vancouver, British Columbia, Canada.""}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27865'] 820,31499249,"Rapid Recurrence of Eosinophilic Esophagitis Activity After Successful Treatment in the Observation Phase of a Randomized, Double-Blind, Double-Dummy Trial.","BACKGROUND & AIMS Eosinophilic esophagitis (EoE) is chronic and recurs if treatment is discontinued. We aimed to determine rates of recurrence, and whether initial treatment with oral viscous budesonide (OVB) resulted in less recurrence than fluticasone from a multidose inhaler (MDI). METHODS This was the observation phase of a randomized, double-blind, double-dummy trial comparing OVB with MDI for initial EoE treatment. Subjects with a histologic response (<15 eosinophils/high-power field) in the trial entered an observation phase in which treatment was discontinued and symptoms were monitored. Patients underwent an endoscopy or a biopsy when symptoms recurred or at 1 year. We analyzed time to symptom recurrence and assessed endoscopic severity and histologic relapse (≥15 eosinophils/high-power field) at follow-up endoscopy. RESULTS Thirty-three of the 58 subjects (57%) had symptom recurrence before 1 year. The overall median time to symptom recurrence was 244 days. There was no difference in the rate of symptom recurrence for subjects treated with OVB vs MDI (hazard ratio, 1.04; 95% CI, 0.52-2.08). At symptom recurrence, 78% of patients had histologic relapse. The patients had significant increases in mean Dysphagia Symptom Questionnaire score (3.8 vs 8.7; P < .001), and the EoE Endoscopic Reference Score (1.3 vs 4.6; P < .001) compared with end of treatment. CONCLUSIONS EoE disease activity recurred rapidly after initial histologic response to topical steroids (either OVB or MDI). Because most subjects had recurrent endoscopic and histologic signs not reliably detected by symptoms, maintenance therapy should be recommended in EoE patients achieving histologic response to topical steroids. Clinicaltrials.gov no: NCT02019758.",2020,"The patients had significant increases in mean Dysphagia Symptom Questionnaire score (3.8 vs 8.7; P<.001), and the EoE Endoscopic Reference Score (1.3 vs 4.6; P<.001) compared to end-of-treatment. ",['Subjects with histologic response (fewer than 15 eosinophils/high-power field'],"['oral viscous budesonide (OVB', 'fluticasone', 'endoscopy or biopsy']","['histologic relapse', 'Eosinophilic Esophagitis Activity', 'mean Dysphagia Symptom Questionnaire score', 'overall median time to symptom recurrence', 'rate of symptom recurrence', 'symptom recurrence', 'histologic response', 'recurrent endoscopic and histologic signs', 'time to symptom recurrence and assessed endoscopic severity and histologic relapse', 'EoE Endoscopic Reference Score']","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4524105', 'cui_str': 'Symptom recurrence'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.697784,"The patients had significant increases in mean Dysphagia Symptom Questionnaire score (3.8 vs 8.7; P<.001), and the EoE Endoscopic Reference Score (1.3 vs 4.6; P<.001) compared to end-of-treatment. ","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina. Electronic address: edellon@med.unc.edu.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Woosley', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Arrington', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'McGee', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Covington', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Moist', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Gebhart', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Galanko', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Shaheen', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.08.050'] 821,28689056,Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.,"The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.",2017,"Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion.","['340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas', 'Eligible patients']","['annual low-dose computed tomography (CT) screening', 'CT-based lung cancer screening', 'usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion', 'telephone-based patient navigation']","['self-reported tobacco use and other patient-reported outcomes', 'lung cancer mortality']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",340.0,0.117557,"Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion.","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA; Medical Oncology Clinic, Parkland Health and Hospital System, Dallas, TX, USA; Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA; Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: david.gerber@UTSouthwestern.edu.'}, {'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Hamann', 'Affiliation': 'Departments of Psychology and Family and Community Medicine, University of Arizona, Tucson, AZ, USA; Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: heidihamann@email.arizona.edu.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Ambulatory Services, Parkland Health and Hospital System, Dallas, TX, USA. Electronic address: noel.santini@phhs.org.'}, {'ForeName': 'Suhny', 'Initials': 'S', 'LastName': 'Abbara', 'Affiliation': 'Departments of Radiology, UT Southwestern Medical Center, Parkland Health and Hospital System, Dallas, TX, USA. Electronic address: suhny.abbara@utsouthwestern.edu.'}, {'ForeName': 'Hsienchang', 'Initials': 'H', 'LastName': 'Chiu', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA; Lung Diagnostics Clinic, Parkland Health and Hospital System, Dallas, TX, USA. Electronic address: hsienchang.chiu@utsouthwestern.edu.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'McGuire', 'Affiliation': 'Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: molly2.mcguire@utsouthwestern.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Quirk', 'Affiliation': 'Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: lisa.quirk@utsouthwestern.edu.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA; Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: hong.zhu@utsouthwestern.edu.'}, {'ForeName': 'Simon J Craddock', 'Initials': 'SJC', 'LastName': 'Lee', 'Affiliation': 'Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA; Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: simoncraddock.lee@utsouthwestern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2017.07.003'] 822,29366724,Effects of Community-Based Exercise in Adults With Severe Burns: A Randomized Controlled Trial.,"OBJECTIVE To investigate the efficacy of community-based exercise programs in the rehabilitation of adult patients with burns compared with standard of care (SOC). DESIGN Randomized controlled trial, with 2:1 randomization. SETTING Assessments were performed in a hospital setting. The intervention was performed in a community setting. PARTICIPANTS Adult patients (N=45) with ≥30% total body surface area burns were randomized to participate in a community-based exercise program (n=31) or SOC (n=14). Patient sampling was consecutive and referred. INTERVENTIONS The community-based exercise program consisted of 12 weeks of exercise with a community-based trainer after hospital discharge. The SOC group did not receive exercise training. MAIN OUTCOME MEASURES Change in lean body mass index, peak torque, and peak oxygen consumption from discharge to 12 weeks postdischarge, presented as mean ± SE. RESULTS The community-based exercise program group showed a significant increase in peak oxygen consumption compared with SOC (community-based exercise program: Δ=7.723±1.522mL/kg/min, P=.0006; SOC: Δ=2.200±1.150mL/kg/min, P=.0765; community-based exercise program vs SOC, P=.0236). The community-based exercise program group exhibited a significant within group increase in lean body mass index (Δ=1.107±0.431kg/m 2 , P=.0003; SOC: Δ=1.323±0.873kg/m 2 , P=.2808). Both groups showed significant within-group increases in peak torque (community-based exercise program: Δ=35.645±7.566Nm, P=.0003; SOC: Δ=34.717±11.029Nm, P=.0082). No significant differences were noted between the 2 groups for lean body mass index or peak torque. CONCLUSIONS Patients who participate in a community-based exercise program show significant improvements in cardiopulmonary fitness compared with SOC, supporting the use of a community-based exercise program as an alternative therapy to SOC in adults with severe burns.",2020,"The community-based exercise program group showed a significant increase in peak oxygen consumption compared with SOC (community-based exercise program: Δ=7.723±1.522mL/kg/min, P=.0006; SOC: Δ=2.200±1.150mL/kg/min, P=.0765; community-based exercise program vs SOC, P=.0236).","['Adult patients (N=45) with ≥30% total body surface area burns', 'adults with severe burns', 'adult patients with burns compared with standard of care (SOC', 'Adults With Severe Burns']","['exercise training', 'community-based exercise program (n=31) or SOC', 'community-based exercise program', 'exercise with a community-based trainer', 'community-based exercise programs', 'Community-Based Exercise']","['lean body mass index, peak torque, and peak oxygen consumption from discharge to 12 weeks postdischarge, presented as mean ± SE', 'peak torque', 'lean body mass index or peak torque', 'peak oxygen consumption', 'cardiopulmonary fitness', 'lean body mass index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",45.0,0.0480262,"The community-based exercise program group showed a significant increase in peak oxygen consumption compared with SOC (community-based exercise program: Δ=7.723±1.522mL/kg/min, P=.0006; SOC: Δ=2.200±1.150mL/kg/min, P=.0765; community-based exercise program vs SOC, P=.0236).","[{'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Voigt', 'Affiliation': 'Department of Surgery, Creighton University, Omaha, NE.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Foncerrada', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Peña', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Guillory', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Andersen', 'Affiliation': 'Department of Preventative Medicine and Community Health, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Wolf', 'Affiliation': 'Division of Burns, Trauma, and Critical Care, Department of Surgery, University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Herndon', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Oscar E', 'Initials': 'OE', 'LastName': 'Suman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX. Electronic address: oesuman@utmb.edu.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2017.12.022'] 823,32406553,Alcohol Cue-Induced Ventral Striatum Activity Predicts Subsequent Alcohol Self-Administration.,"BACKGROUND Human laboratory paradigms are a pillar in medication development for alcohol use disorders (AUD). Neuroimaging paradigms, in which individuals are exposed to cues that elicit neural correlates of alcohol craving (e.g., mesocorticolimbic activation), are increasingly utilized to test the effects of AUD medications. Elucidation of the translational effects of these neuroimaging paradigms on human laboratory paradigms, such as self-administration, is warranted. The current study is a secondary analysis examining whether alcohol cue-induced activation in the ventral striatum is predictive of subsequent alcohol self-administration in the laboratory. METHODS Non-treatment-seeking heavy drinkers of East Asian descent (n = 41) completed a randomized, placebo-controlled, double-blind, crossover experiment on the effects of naltrexone on neuroimaging and human laboratory paradigms. Participants completed 5 days of study medication (or placebo); on day 4, they completed a neuroimaging alcohol taste cue-reactivity task. On the following day (day 5), participants completed a 60-minute alcohol self-administration paradigm. RESULTS Multilevel Cox regressions indicated a significant effect of taste cue-elicited ventral striatum activation on latency to first drink, Wald χ 2  = 2.88, p = 0.05, such that those with higher ventral striatum activation exhibited shorter latencies to consume their first drink. Similarly, ventral striatum activation was positively associated with total number of drinks consumed, F(1, 38) = 5.90, p = 0.02. These effects were significant after controlling for alcohol use severity, OPRM1 genotype, and medication. Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes. CONCLUSIONS Neuroimaging alcohol taste cue paradigms may be predictive of laboratory paradigms such as self-administration. Elucidation of the relationships among different paradigms will inform how these paradigms may be used synergistically in experimental medicine and medication development.",2020,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes. ",['Non-treatment-seeking heavy drinkers of East Asian descent (n\xa0=\xa041'],"['naltrexone', 'placebo']","['taste cue-elicited ventral striatum activation', 'ventral striatum activation']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",41.0,0.0517698,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes. ","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Meredith', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Donato', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burnette', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14342'] 824,31971899,Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial.,"OBJECTIVES This study compared the efficacy and safety of the VASCADE MVP Venous Vascular Closure System (VVCS) device (Cardiva Medical, Santa Clara, California) to manual compression (MC) for closing multiple access sites after catheter-based electrophysiology procedures. BACKGROUND The VASCADE MVP VVCS is designed to provide earlier ambulatory hemostasis than MC after catheter-based procedures. METHODS The AMBULATE (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore [VASCADE MVP] VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes) trial was a multicenter, randomized trial of device closure versus MC in patients who underwent ablation. Outcomes included time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, pain medication usage, and patient-reported outcomes. RESULTS A total of 204 patients at 13 sites were randomized to the device arm (n = 100; 369 access sites) or the MC arm (n = 104; 382 access sites). Baseline characteristics were similar between groups. Mean TTA, TPPT, TTDe, and TTH were substantially lower in the device arm (respective decreases of 54%, 54%, 52%, and 55%; all p < 0.0001). Opioid use was reduced by 58% (p = 0.001). There were no major access site complications. Incidence of minor complications was 1.0% for the device arm and 2.4% for the MC arm (p = 0.45). Patient satisfaction scores with duration of and comfort during bedrest were 63% and 36% higher in device group (both p < 0.0001). Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (p = 0.002) for patients with a previous ablation. CONCLUSIONS Use of the closure device for multiple access ablation procedures resulted in significant reductions in TTA, TPPT, TTH, TTDe, and opioid use, with increased patient satisfaction and no increase in complications. (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes [AMBULATE]; NCT03193021).",2020,"Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (","['patients who underwent ablation', '204 patients at 13 sites', 'patients with a previous ablation']","['device closure versus MC', 'Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures', 'Cardiva Mid-Bore VVCS to Manual Compression', 'VASCADE MVP Venous Vascular Closure System (VVCS) device (Cardiva Medical, Santa Clara, California) to manual compression (MC', 'Cardiva Mid-Bore [VASCADE MVP] VVCS to Manual Compression']","['time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, pain medication usage, and patient-reported outcomes', 'TTA, TPPT, TTH, TTDe, and opioid use, with increased patient satisfaction', 'Opioid use', 'Mean TTA, TPPT, TTDe, and TTH', 'Incidence of minor complications', 'Patient satisfaction scores with duration of and comfort during bedrest', 'Satisfaction with bedrest pain', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0449238', 'cui_str': 'Duration (attribute)'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",204.0,0.327771,"Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Dell Medical School, University of Texas, Austin, Texas; Case Western Reserve University, Cleveland, Ohio; Interventional Electrophysiology, Scripps Clinic, San Diego, California.""}, {'ForeName': 'Sanghamitra', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Dell Medical School, University of Texas, Austin, Texas.""}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Valley Health System and the Snyder Center for Comprehensive Atrial Fibrillation, Ridgewood, New Jersey.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'De Lurgio', 'Affiliation': 'Emory Healthcare, Atlanta, Georgia.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Horton', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Spear', 'Affiliation': 'Advocate Christ Medical Center, Oak Lawn, Illinois.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bunch', 'Affiliation': 'Intermountain Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Musat', 'Affiliation': 'Valley Health System and the Snyder Center for Comprehensive Atrial Fibrillation, Ridgewood, New Jersey.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Neill"", 'Affiliation': 'Mercy Medical Group, Sacramento, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Alaska Heart and Vascular Institute, Anchorage, Alaska.'}, {'ForeName': 'Mintu P', 'Initials': 'MP', 'LastName': 'Turakhia', 'Affiliation': 'Stanford University, Stanford, California; VA Palo Alto Health Care System, Palo Alto, California. Electronic address: mintu@stanford.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.08.013'] 825,31971914,A comparison of the effect of pressure on the KID21 (Youmen) and P6 (Neiguan) points on the severity of nausea and vomiting of pregnancy.,"Background Nausea and vomiting of pregnancy (NVP) is the most common problem for women in early pregnancy. The present study was conducted to compare the effect of pressure on KID21 and P6 on the severity of NVP. Methods This single-blind clinical trial was conducted on pregnant women in their first trimester with NVP, referring to the clinic of Ayatollah Rouhani Hospital of Babol, Iran, in 2017. Eighty-two participants were randomly divided into KID21 and P6 pressure groups. The researcher applied pressure on these two points 20 min each day for four consecutive days. The severity of nausea and vomiting was then assessed using the visual analog scale (VAS) by the patient and counting its frequency in 24 h, respectively. Finally, the collected data were analyzed using SPSS 22 by repeated measures ANOVA and paired sample T-Test. Results The severity of NVP in the 82 participating pregnant women decreased in both groups (p<0.001), and there was no significant difference between the two groups in terms of the severity of NVP (p=0.68), although the reduction in nausea was greater in the P6 group than KID21 group, and the reduction in vomiting was greater in the KID21 group than the P6 group. Effect size for vomiting and nausea was 0.28 and 0.16, respectively. No side-effects were observed in the two groups during these four days. Conclusions Pressure on P6 and KID21 points has no advantage over each other in the treatment of NVP, but acupressure is an effective, complication-free, inexpensive and accessible treatment for this complication.",2020,"The severity of NVP in the 82 participating pregnant women decreased in both groups (p<0.001), and there was no significant difference between the two groups in terms of the severity of NVP (p=0.68), although the reduction in nausea was greater in the P6 group than KID21 group, and the reduction in vomiting was greater in the KID21 group than the P6 group.","['Eighty-two participants were randomly divided into KID21 and P6 pressure groups', 'pregnant women in their first trimester with NVP, referring to the clinic of Ayatollah Rouhani Hospital of Babol, Iran, in 2017', 'women in early pregnancy', '82 participating pregnant women']",[],"['side-effects', 'reduction in vomiting', ' Nausea and vomiting of pregnancy (NVP', 'severity of nausea and vomiting', 'reduction in nausea', 'severity of NVP', 'visual analog scale (VAS', 'vomiting and nausea', 'nausea and vomiting of pregnancy']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",[],"[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",82.0,0.033634,"The severity of NVP in the 82 participating pregnant women decreased in both groups (p<0.001), and there was no significant difference between the two groups in terms of the severity of NVP (p=0.68), although the reduction in nausea was greater in the P6 group than KID21 group, and the reduction in vomiting was greater in the KID21 group than the P6 group.","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Galeshi', 'Affiliation': 'Clinical Research Development Unit of Rouhani Hospital, Master of Science, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Ghanbarpour', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Naeimi Rad', 'Affiliation': 'Clinical Research Development Unit of Rouhani Hospital, Master of Science, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Shokat', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Basic of Science, Rouhani Hospital, Babol University of Medical Science, Babol, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0035'] 826,31373922,The association of smoothness index of central blood pressure with ambulatory carotid femoral pulse wave velocity after 20-week treatment with losartan in combination with amlodipine versus hydrochlorothiazide.,"OBJECTIVES The aim of this study was to identify associations between the smoothness index of central SBP (CSBP) and changes of ambulatory carotid femoral pulse wave velocity in response to 20-week treatments with losartan and amlodipine vs. losartan and hydrochlorthiazide combinations. METHODS For 142 (losartan and hydrochlorthiazide: 72, losartan and hydrochlorthiazide: 70) patients examined with ambulatory central blood pressure (BP) monitoring device, we calculated smoothness indices and trough-to-peak ratios of brachial SBP, CSBP, ambulatory pulse pressure amplification (APPA), ambulatory augmentation index at heart rate 75 beats per minute (AAIx75) and ambulatory carotid femoral pulse wave velocity (AcfPWV). RESULTS Mean age was 58.9 ± 12.3 years, and women accounted for 25.9%. Changes in office SBP/DBP were not different between groups (losartan and hydrochlorthiazide: -15.2 ± 15.0/-7.8 ± 8.0 vs. losartan and amlodipine: -14.9 ± 13.7/-9.2 ± 7.5 mmHg). Reduction of 24-h CSBP was not significantly different (losartan and hydrochlorthiazide: 6.4 ± 1.1 vs. losartan and amlodipine: 9.2 ± 1.1 mmHg, P = 0.074). Reduction in nocturnal AcfPWV was greater in the losartan and amlodipine group (losartan and hydrochlorthiazide: 0.09 ± 0.05 vs. losartan and amlodipine: 0.26 ± 0.05 m/s, P = 0.0216). Intraindividual SIs for CSBP were higher in the losartan and amlodipine group (0.40 ± 0.57 vs. 0.65 ± 0.74, P = 0.022). In multivariable regression analysis, smoothness index of CSBP was independently associated with the losartan and amlodipine group. In model additionally considering the changes in arterial stiffness, decrease in AcfPWV instead of the treatment group was independently associated with smoothness indices. In mediation analysis, smoothness index was fully mediated by reduction in night-time AcfPWV. CONCLUSION Losartan and amlodipine combination was superior to the losartan and hydrochlorthiazide combination in terms of achieving higher smoothness index for CSBP after 20-week treatments. The effect of losartan and amlodipine on smoothness index was fully mediated by reduction of night-time AcfPWV.",2019,"Reduction of 24-h CSBP was not significantly different (losartan and hydrochlorthiazide: 6.4 ± 1.1 vs. losartan and amlodipine: 9.2 ± 1.1 mmHg, P = 0.074).","['Mean age was 58.9\u200a±\u200a12.3 years, and women accounted for 25.9']","['losartan', 'amlodipine', 'hydrochlorothiazide', 'losartan and hydrochlorthiazide', 'losartan and amlodipine', '142 (losartan and hydrochlorthiazide', 'losartan and amlodipine vs. losartan and hydrochlorthiazide combinations']","['nocturnal', 'SBP/DBP', 'Reduction of 24-h CSBP', 'smoothness index of CSBP', 'ambulatory central blood pressure (BP) monitoring device, we calculated smoothness indices and trough-to-peak ratios of brachial SBP, CSBP, ambulatory pulse pressure amplification (APPA), ambulatory augmentation index at heart rate 75 beats per minute (AAIx75) and ambulatory carotid femoral pulse wave velocity (AcfPWV', 'smoothness index', 'AcfPWV', 'arterial stiffness', 'smoothness index of central SBP (CSBP', 'Intraindividual SIs for CSBP']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C3652748', 'cui_str': 'losartan and amlodipine'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}]",,0.0167199,"Reduction of 24-h CSBP was not significantly different (losartan and hydrochlorthiazide: 6.4 ± 1.1 vs. losartan and amlodipine: 9.2 ± 1.1 mmHg, P = 0.074).","[{'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hanyang University Hospital, Seoul.'}, {'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul.'}, {'ForeName': 'Wook Jin', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Gil Hospital, Gachon University, Incheon.'}, {'ForeName': 'Ho Joong', 'Initials': 'HJ', 'LastName': 'Youn', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, St. Mary's Hospital.""}, {'ForeName': 'Eun Joo', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, St. Paul's Hospital, Catholic University.""}, {'ForeName': 'Ki Chul', 'Initials': 'KC', 'LastName': 'Sung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul.'}, {'ForeName': 'Shung Chull', 'Initials': 'SC', 'LastName': 'Chae', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu.'}, {'ForeName': 'Byung Su', 'Initials': 'BS', 'LastName': 'Yoo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju.'}, {'ForeName': 'Chang Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Seoul.'}, {'ForeName': 'Soon-Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Seoul.'}, {'ForeName': 'Taek Jong', 'Initials': 'TJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan.'}, {'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Bundang Seoul National University Hospital, Seongnam.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Ha', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University, Seoul.'}, {'ForeName': 'Young Jo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Daegu.'}, {'ForeName': 'Young Keun', 'Initials': 'YK', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju.'}, {'ForeName': 'Myeong-Chan', 'Initials': 'MC', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju.'}, {'ForeName': 'Soon Kil', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri.'}, {'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University, Seoul.'}, {'ForeName': 'Il-Suk', 'Initials': 'IS', 'LastName': 'Sohn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kyung Hee University at Gangdong.'}, {'ForeName': 'Chong-Jin', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'Kyunghee University Hospital at Gangdong, Seoul, South Korea.'}]",Journal of hypertension,['10.1097/HJH.0000000000002202'] 827,31971274,Early Screening for Aortic Dissection With Point-of-Care Ultrasound by Emergency Physicians: A Prospective Pilot Study.,"OBJECTIVES To investigate the effect of point-of-care ultrasound (POCUS) use by emergency physician (EPs) on the diagnosis, treatment, and safety of POCUS in patients with aortic dissection (AD) in emergency settings. METHODS Patients presenting to the emergency department of West China Hospital of Sichuan University with suspected AD from July 1, 2016, to December 31, 2016 were divided into a control group and an ultrasound (US) group. The control group was evaluated by routine procedures for triage, diagnosis, and treatment. In addition, an EP POCUS examination was performed in the US group. The patients in the US group were furtherly divided into subgroup A and subgroup B according to the Stanford type of AD. The sensitivity and specificity of EP POCUS compared to computed tomographic angiography (CTA) were compared. The door-to-CTA examination time, door-to-diagnosis time, door-to-targeted treatment time, and outcome were compared between the groups. RESULTS A total of 127 patients were enrolled: 72 in the US group and 55 in the control group. In the US group, compared with CTA, the sensitivity of EP POCUS was 86.4%, and the specificity was 100.0%. The door-to-diagnosis times were 10.5 minutes in the US group and 79.0 minutes in the control group (P < .05). The door-to-CTA examination time and the door-to-targeted-treatment time had no differences between the US and control groups (P > .05). The in-hospital mortality and mortality within 3 months after discharge were 4.2% and 25.0% in the US group and 9.1% and 20.8% in the control group (P > .05). CONCLUSIONS Compared with CTA, EP POCUS in patients suspected of having AD is highly sensitive and specific and has shown no adverse effect on the treatment start-up time, in-hospital mortality, and mortality within 3 months after discharge.",2020,The door-to-CTA examination time and the door-to-targeted-treatment time had no differences between the US and control groups (P > .05).,"['127 patients were enrolled: 72 in the US group and 55 in the control group', 'Patients presenting to the emergency department of West China Hospital of Sichuan University with suspected AD from July 1, 2016, to December 31, 2016 were divided into a control group and an ultrasound (US) group', 'Early Screening for Aortic Dissection With Point-of-Care Ultrasound by Emergency Physicians', 'patients with aortic dissection (AD) in emergency settings']","['CTA, EP POCUS', 'point-of-care ultrasound (POCUS', 'computed tomographic angiography (CTA']","['hospital mortality and mortality', 'sensitivity of EP POCUS', 'sensitivity and specificity of EP POCUS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0340643', 'cui_str': 'Aortic Dissection'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",127.0,0.0169226,The door-to-CTA examination time and the door-to-targeted-treatment time had no differences between the US and control groups (P > .05).,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Haifang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Emergency Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Emergency Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': 'Department of Emergency Medicine, West China Hospital, Sichuan University, Chengdu, China.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15223'] 828,31971279,Effects of Therapeutic Ultrasound Applied to the Lumbar Region on Renal Function: A Randomized Controlled Prospective Trial.,"OBJECTIVES Therapeutic ultrasound (TUS) is one of the most commonly used modalities in low back pain treatment. The objective of this study was to determine whether TUS applied to the low back region in patients with chronic low back pain had any effect on renal function. METHODS Forty patients with chronic low back pain were randomized to 2 groups by a block randomization method. Thirty-seven patients completed the final evaluation. All patients were treated for 5 sessions per week for 3 weeks with the same physiotherapy modalities (superficial heating and transcutaneous electrical nerve stimulation) and exercise therapy; in addition to these treatments, the second group was treated with TUS for 10 minutes (frequency, 1 MHz; intensity, 1.5 W/cm 2 ; and effective irradiation area of the transducer head, 5 cm 2 ). The serum creatinine, serum cystatin C, 24-hour urine creatinine, creatinine clearance, 24-hour urine microalbumin and microprotein, urine volume, and glomerular filtration rate were measured. The patients were evaluated at baseline (day 0) and the end of the treatment (day 21). RESULTS The serum cystatin C levels were increased in both groups, but this increase was not significant (P > .05). There was no difference between the groups in the percent change in all outcome measures (P > .05). CONCLUSIONS This showed that TUS applied to the low back region does not affect renal function.",2020,"The serum cystatin C levels were increased in both groups, but this increase was not significant (P > .05).","['Forty patients with chronic low back pain', 'patients with chronic low back pain had any effect on renal function', 'Lumbar Region on Renal Function', 'Thirty-seven patients completed the final evaluation']","['Therapeutic Ultrasound', 'physiotherapy modalities (superficial heating and transcutaneous electrical nerve stimulation) and exercise therapy', 'TUS', 'Therapeutic ultrasound (TUS']","['serum creatinine, serum cystatin C, 24-hour urine creatinine, creatinine clearance, 24-hour urine microalbumin and microprotein, urine volume, and glomerular filtration rate', 'renal function', 'serum cystatin C levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0740086', 'cui_str': 'Microalbuminuria measurement'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",40.0,0.0401921,"The serum cystatin C levels were increased in both groups, but this increase was not significant (P > .05).","[{'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Mengi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bagcilar Training and Research Hospital, Bagcilar, Istanbul, Turkey.'}, {'ForeName': 'Senay', 'Initials': 'S', 'LastName': 'Ozdolap', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bulent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Tugce', 'Initials': 'T', 'LastName': 'Koksal', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bulent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Furuzan', 'Initials': 'F', 'LastName': 'Kokturk', 'Affiliation': 'Department of Biostatistics, Bulent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Can', 'Affiliation': 'Department of Biochemistry, Bulent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Sarikaya', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bulent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15225'] 829,31960954,Drug therapy for delirium in terminally ill adults.,"BACKGROUND Delirium is a syndrome characterised by an acute disturbance of attention and awareness which develops over a short time period and fluctuates in severity over the course of the day. It is commonly experienced during inpatient admission in the terminal phase of illness. It can cause symptoms such as agitation and hallucinations and is distressing for terminally ill people, their families and staff. Delirium may arise from any number of causes and treatment should aim to address these causes. When this is not possible, or treatment is unsuccessful, drug therapy to manage the symptoms may become necessary. This is the second update of the review first published in 2004. OBJECTIVES To evaluate the effectiveness and safety of drug therapies to manage delirium symptoms in terminally ill adults. SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO from inception to July 2019, reference lists of retrieved papers, and online trial registries. SELECTION CRITERIA We included randomised controlled trials of drug therapies in any dose by any route, compared to another drug therapy, a non-pharmacological approach, placebo, standard care or wait-list control, for the management of delirium symptoms in terminally ill adults (18 years or older). DATA COLLECTION AND ANALYSIS We independently screened citations, extracted data and assessed risk of bias. Primary outcomes were delirium symptoms; agitation score; adverse events. Secondary outcomes were: use of rescue medication; cognitive status; survival. We applied the GRADE approach to assess the overall quality of the evidence for each outcome and we include eight 'Summary of findings' tables. MAIN RESULTS We included four studies (three new to this update), with 399 participants. Most participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium. Meta-analysis was not possible because no two studies examined the same comparison. Each study was at high risk of bias for at least one criterion. Most evidence was low to very low quality, downgraded due to very serious study limitations, imprecision or because there were so few data. Most studies reported delirium symptoms; two reported agitation scores; three reported adverse events with data on extrapyramidal effects; and none reported serious adverse events. 1. Haloperidol versus placebo There may be little to no difference between placebo and haloperidol in delirium symptoms within 24 hours (mean difference (MD) 0.34, 95% confidence interval (CI) -0.07 to 0.75; 133 participants). Haloperidol may slightly worsen delirium symptoms compared with placebo at 48 hours (MD 0.49, 95% CI 0.10 to 0.88; 123 participants with mild- to moderate-severity delirium). Haloperidol may reduce agitation slightly compared with placebo between 24 and 48 hours (MD -0.14, 95% -0.28 to -0.00; 123 participants with mild- to moderate-severity delirium). Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium). 2. Haloperidol versus risperidone There may be little to no difference in delirium symptoms with haloperidol compared with risperidone within 24 hours (MD -0.42, 95% CI -0.90 to 0.06; 126 participants) or 48 hours (MD -0.36, 95% CI -0.92 to 0.20; 106 participants with mild- to moderate-severity delirium). Agitation scores and adverse events were not reported for this comparison. 3. Haloperidol versus olanzapine We are uncertain whether haloperidol reduces delirium symptoms compared with olanzapine within 24 hours (MD 2.36, 95% CI -0.75 to 5.47; 28 participants) or 48 hours (MD 1.90, 95% CI -1.50 to 5.30, 24 participants). Agitation scores and adverse events were not reported for this comparison. 4. Risperidone versus placebo Risperidone may slightly worsen delirium symptoms compared with placebo within 24 hours (MD 0.76, 95% CI 0.30 to 1.22; 129 participants); and at 48 hours (MD 0.85, 95% CI 0.32 to 1.38; 111 participants with mild- to moderate-severity delirium). There may be little to no difference in agitation with risperidone compared with placebo between 24 and 48 hours (MD -0.05, 95% CI -0.19 to 0.09; 111 participants with mild- to moderate-severity delirium). Risperidone may increase extrapyramidal adverse effects compared with placebo (MD 0.73 95% CI 0.09 to 1.37; 111 participants with mild- to moderate-severity delirium). 5. Lorazepam plus haloperidol versus placebo plus haloperidol We are uncertain whether lorazepam plus haloperidol compared with placebo plus haloperidol improves delirium symptoms within 24 hours (MD 2.10, 95% CI -1.00 to 5.20; 50 participants with moderate to severe delirium), reduces agitation within 24 hours (MD 1.90, 95% CI 0.90 to 2.80; 52 participants), or increases adverse events (RR 0.70, 95% CI -0.19 to 2.63; 31 participants with moderate to severe delirium). 6. Haloperidol versus chlorpromazine We are uncertain whether haloperidol reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 0.37, 95% CI -4.58 to 5.32; 24 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with chlorpromazine (MD 0.46, 95% CI -4.22 to 5.14; 24 participants). 7. Haloperidol versus lorazepam We are uncertain whether haloperidol reduces delirium symptoms compared with lorazepam at 48 hours (MD -4.88, 95% CI -9.70 to 0.06; 17 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with lorazepam (MD -6.66, 95% CI -14.85 to 1.53; 17 participants). 8. Lorazepam versus chlorpromazine We are uncertain whether lorazepam reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 5.25, 95% CI 0.38 to 10.12; 19 participants), or increases adverse events (MD 7.12, 95% CI 1.08 to 15.32; 18 participants). Agitation scores were not reported. SECONDARY OUTCOMES use of rescue medication, cognitive impairment, survival There were insufficient data to draw conclusions or assess GRADE. AUTHORS' CONCLUSIONS We found no high-quality evidence to support or refute the use of drug therapy for delirium symptoms in terminally ill adults. We found low-quality evidence that risperidone or haloperidol may slightly worsen delirium symptoms of mild to moderate severity for terminally ill people compared with placebo. We found moderate- to low-quality evidence that haloperidol and risperidone may slightly increase extrapyramidal adverse events for people with mild- to moderate-severity delirium. Given the small number of studies and participants on which current evidence is based, further research is essential.",2020,"Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium).","['terminally ill adults', 'participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium', '123 participants with mild- to moderate-severity delirium', '399 participants', 'terminally ill adults (18 years or older', 'delirium in terminally ill adults', 'people with mild- to moderate-severity delirium']","['olanzapine', 'haloperidol', 'lorazepam plus haloperidol', 'Haloperidol', 'placebo, standard care or wait-list control', 'lorazepam', 'placebo plus haloperidol', 'risperidone', 'placebo Risperidone', 'placebo', 'chlorpromazine', 'Risperidone', 'Lorazepam', 'haloperidol and risperidone', 'Lorazepam plus haloperidol']","['Agitation scores and adverse events', 'Agitation scores', 'use of rescue medication; cognitive status; survival', 'extrapyramidal adverse events', 'reduces agitation', 'effectiveness and safety', 'rescue medication, cognitive impairment, survival There were insufficient data to draw conclusions or assess GRADE', 'extrapyramidal adverse effects', 'adverse events', 'delirium symptoms; agitation score; adverse events', 'delirium symptoms', 'agitation']","[{'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",123.0,0.609966,"Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium).","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Finucane', 'Affiliation': 'Marie Curie Hospice Edinburgh, 45 Frogston Road West, Edinburgh, UK, EH10 7DR.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Leurent', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Medical Statistics, London, UK.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stone', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tookman', 'Affiliation': 'Marie Curie Hospice, 11 Lyndhurst Gardens, Hamstead, London, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Candy', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004770.pub3'] 830,31467033,Consistent control of disease activity with fingolimod versus IFN β-1a in paediatric-onset multiple sclerosis: further insights from PARADIG MS .,"BACKGROUND In PARADIG MS , a double-blind phase III trial in 215 paediatric patients with multiple sclerosis (MS) (10 to <18 years), fingolimod administered for up to 2 years significantly reduced the annualised relapse rate (ARR) and rate of new/newly enlarged T2 (n/neT2) lesions compared with interferon (IFN) β-1a. OBJECTIVES To investigate (1) differences between treatment groups across subpopulations (treatment-naïve, younger/prepubertal patients); (2) disability progression. METHODS ARRs at 10, 11 and 12 years were estimated based on predefined modelling extrapolations. Changes in Expanded Disability Status Scale (EDSS), and in 3 month (3M) and 6 month (6M) confirmed disability progression (CDP) were evaluated post hoc. RESULTS In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population. Model-based ARR reductions in younger patients (≤12 years) were 91.9%-94.6%. Twice as many IFN β-1a-treated than fingolimod-treated patients had worse EDSS scores at study end (20.6% vs 10.5%, p=0.043). Risk reductions in 3M-CDP and 6M-CDP were 77.2% (p=0.007) and 80.2% (p=0.040), respectively. CONCLUSIONS Fingolimod in paediatric MS was associated with consistent control of disease activity versus IFN β-1a (including treatment-naïve and younger patients) and resulted in less disability progression for up to 2 years. TRIAL REGISTRATION NUMBER NCT01892722.",2020,"In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population.","['215 paediatric patients with multiple sclerosis (MS) (10 to <18 years', 'paediatric-onset multiple sclerosis', 'younger patients (≤12 years', 'ARRs at 10, 11 and 12 years were estimated based on predefined modelling extrapolations']","['interferon (IFN) β-1a', 'fingolimod versus IFN β-1a']","['Risk reductions in 3M-CDP and 6M-CDP', 'Expanded Disability Status Scale (EDSS), and in 3\u2009month (3M) and 6\u2009month (6M) confirmed disability progression (CDP', 'annualised relapse rate (ARR) and rate of new/newly enlarged T2 (n/neT2) lesions', 'disability progression', 'EDSS scores', 'ARR and n/neT2 lesions']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",215.0,0.0515039,"In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population.","[{'ForeName': 'Kumaran', 'Initials': 'K', 'LastName': 'Deiva', 'Affiliation': 'Department of Pediatric Neurology, National Referral Center for Rare Inflammatory Brain and Spinal Diseases, Hopitaux Universitaires Paris-Sud, Le Kremlin-Bicetre, France kumaran.deiva@bct.aphp.fr.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Huppke', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence, University Medical Center Göttingen, Gottingen, Germany.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Banwell', 'Affiliation': ""Perelman School of Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Tanuja', 'Initials': 'T', 'LastName': 'Chitnis', 'Affiliation': 'Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gärtner', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence, University Medical Center Göttingen, Gottingen, Germany.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Krupp', 'Affiliation': 'Pediatric MS Center, NYU Langone Health, New York City, New York, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Waubant', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Stites', 'Affiliation': 'Neuroscience Department, Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.'}, {'ForeName': 'Gregory Lewis', 'Initials': 'GL', 'LastName': 'Pearce', 'Affiliation': 'Statistics Department, GCE Solutions, Bloomington, Illinois, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Merschhemke', 'Affiliation': 'Neuroscience Development Unit, Novartis Pharma AG, Basel, Switzerland.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-321124'] 831,31474439,Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Phase 2 Trial.,"PURPOSE Geographic atrophy (GA), a late stage of age-related macular degeneration (AMD), is a major cause of blindness. Even while central visual acuity remains relatively well preserved, GA often causes considerable compromise of visual function and quality of life. No treatment currently exists. We evaluated the safety and efficacy of pegcetacoplan, a complement C3 inhibitor, for treatment of GA. DESIGN Prospective, multicenter, randomized, sham-controlled phase 2 study. PARTICIPANTS Two hundred forty-six patients with GA. METHODS Patients with GA were assigned randomly in a 2:2:1:1 ratio to receive intravitreal injections of 15 mg pegcetacoplan monthly or every other month (EOM) or sham intravitreal injections monthly or EOM for 12 months with follow-up at months 15 and 18. Area and growth of GA were measured using fundus autofluorescence imaging. MAIN OUTCOME MEASURES The primary efficacy end point was mean change in square root GA lesion area from baseline to month 12. Secondary outcome measures included mean change from baseline in GA lesion area without the square root transformation, distance of GA lesion from the fovea, best-corrected visual acuity (BCVA), low-luminance BCVA, and low-luminance visual acuity deficit. The primary safety end point was the number and severity of treatment-emergent adverse events. RESULTS In patients receiving pegcetacoplan monthly or EOM, the GA growth rate was reduced by 29% (95% confidence interval [CI], 9-49; P = 0.008) and 20% (95% CI, 0-40; P = 0.067) compared with the sham treatment group. Post hoc analysis showed that the effect was greater in the second 6 months of treatment, with observed reductions of 45% (P = 0.0004) and 33% (P = 0.009) for pegcetacoplan monthly and EOM, respectively. Two cases of culture-positive endophthalmitis and 1 case of culture-negative endophthalmitis occurred in the pegcetacoplan monthly group. New-onset investigator-determined exudative AMD was reported more frequently in pegcetacoplan-treated eyes (18/86 eyes [20.9%] and 7/79 eyes [8.9%] in monthly and EOM groups, respectively) than in sham-treated eyes (1/81 eyes [1.2%]). CONCLUSIONS Local C3 inhibition with pegcetacoplan resulted in statistically significant reductions in the growth of GA compared with sham treatment. Phase 3 studies will define the efficacy and safety profile further.",2020,"= 0.0004) and 33% (P = 0.009) for pegcetacoplan monthly and EOM, respectively.","['Geographic Atrophy Secondary to Age-Related Macular Degeneration', 'Patients with GA', 'Two hundred forty-six patients with GA']","['Complement C3 Inhibitor Pegcetacoplan', 'pegcetacoplan', 'intravitreal injections of 15 mg pegcetacoplan monthly or every other month (EOM) or sham intravitreal injections monthly or EOM']","['mean change in square root GA lesion area', 'GA growth rate', 'visual function and quality of life', 'culture-negative endophthalmitis', 'mean change from baseline in GA lesion area without the square root transformation, distance of GA lesion from the fovea, best-corrected visual acuity (BCVA), low-luminance BCVA, and low-luminance visual acuity deficit', 'growth of GA', 'New-onset investigator-determined exudative AMD', 'number and severity of treatment-emergent adverse events', 'Area and growth of GA', 'safety and efficacy']","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0009506', 'cui_str': 'Complement C3'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034380'}, {'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C0014236', 'cui_str': 'Ophthalmia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0234684', 'cui_str': 'Luminance, function (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0311438', 'cui_str': 'Exudative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",246.0,0.241444,"= 0.0004) and 33% (P = 0.009) for pegcetacoplan monthly and EOM, respectively.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liao', 'Affiliation': 'Retina-Vitreous Associates Medical Group, Beverly Hills, California. Electronic address: dave_liao@laretina.com.'}, {'ForeName': 'Federico V', 'Initials': 'FV', 'LastName': 'Grossi', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'El Mehdi', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Monica R', 'Initials': 'MR', 'LastName': 'Gerber', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Vitreoretinal Consultants, Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Singerman', 'Affiliation': 'Retina Associates of Cleveland, Cleveland, Ohio.'}, {'ForeName': 'Prema', 'Initials': 'P', 'LastName': 'Abraham', 'Affiliation': 'Black Hills Regional Eye Institute, Rapid City, Iowa.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Grassmann', 'Affiliation': 'Institute of Human Genetics, University of Regensburg, Regensburg, Germany; Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nuernberg', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernhard H F', 'Initials': 'BHF', 'LastName': 'Weber', 'Affiliation': 'Institute of Human Genetics, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Deschatelets', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Robert Y', 'Initials': 'RY', 'LastName': 'Kim', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Carol Y', 'Initials': 'CY', 'LastName': 'Chung', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Ramiro M', 'Initials': 'RM', 'LastName': 'Ribeiro', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamdani', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenfeld', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retina-Vitreous Associates Medical Group, Los Angeles, California.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Slakter', 'Affiliation': 'Vitreous Retina Macula Consultants of New York, New York; New York University School of Medicine, New York, New York.'}, {'ForeName': 'Cedric G', 'Initials': 'CG', 'LastName': 'Francois', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2019.07.011'] 832,31954158,Patient-centered change in the day-to-day impact of postmenopausal vaginal symptoms: results from a multicenter randomized trial.,"BACKGROUND Vulvovaginal symptoms, which include dryness, irritation, and pain with intercourse, are common among postmenopausal women and are associated with impaired sexual functioning and quality of life. Previous assessment of treatment strategies for these symptoms has been limited by a lack of sensitive patient-centered outcome measures that assess symptom impact on functional and quality-of-life domains. OBJECTIVE We aimed to (1) examine change in the impact of postmenopausal vulvovaginal symptoms on multiple aspects of well-being and functioning in relation to vaginal estradiol and moisturizer treatment and (2) guide meaningful interpretation of scores on a structured-item questionnaire measure of condition-specific impact. STUDY DESIGN Data were drawn from postmenopausal women who were enrolled in the Menopause Strategies: Finding Lasting Answers for Symptoms and Health Vaginal Health Trial (a 12-week, double-blind, placebo-controlled randomized trial of treatment for vulvovaginal symptoms) who were assigned to vaginal 10-μg estradiol tablet plus placebo gel (n=98), vaginal moisturizer plus placebo tablet (n=97), or dual placebo (n=94). At baseline and 12-week follow up, participants completed the Day-to-Day Impact of Vaginal Aging questionnaire to assess the impact of vaginal symptoms on 4 domains (activities of daily living, emotional well-being, sexual functioning, and body image), each on a 0-4 point scale. Day-to-Day Impact of Vaginal Aging sensitivity to change was assessed by the examination of the associations between change in Day-to-Day Impact of Vaginal Aging domain scores and vulvovaginal symptom severity from baseline to 12 weeks with analysis of covariance. Within-woman and between-group minimal clinically important improvement was assessed with the use of an anchor-based approach that relates change in Day-to-Day Impact of Vaginal Aging domain scores with self-reported benefit from treatment. RESULTS Participants in all treatment arms (n=289) demonstrated reduced impact of vulvovaginal symptoms on all domains of well-being and functioning as assessed by Day-to-Day Impact of Vaginal Aging at 12-week follow up, with no significant differences in improvement between women who were assigned to either estradiol tablet or vaginal moisturizer compared with placebo. For all Day-to-Day Impact of Vaginal Aging domains, mean impact scores were reduced when participants reported symptom improvement (-0.3 to -0.8 point change in Day-to-Day Impact of Vaginal Aging scores for <2-point symptom severity change vs -0.4 to -1.6 point change in Day-to-Day Impact of Vaginal Aging scores for 2+ point symptom severity change; all P<.001). Minimal clinically important change in Day-to-Day Impact of Vaginal Aging domain scale scores, which are anchored to self-reported meaningful benefit from treatment at 12 weeks, ranged from -0.4 to -1.3 (within-woman) and -0.2 to -0.7 (between-group). Observed change and minimal clinically important difference were largest for the sexual functioning domain. CONCLUSION The impact of vulvovaginal symptoms on day-to-day activities, sexual function, emotional well-being, and body image may be improved with low-dose vaginal estradiol, moisturizer, or topical placebo. The Day-to-Day Impact of Vaginal Aging questionnaire demonstrates sensitivity to change with treatment of vulvovaginal symptoms, particularly Day-to-Day Impact of Vaginal Aging scales that focus on symptom impact on sexual functioning and body image. Minimal clinically important improvement in the impact of vulvovaginal symptoms as measured by the Day-to-Day Impact of Vaginal Aging can be defined with the use of these measures.",2020,,['Postmenopausal Vaginal Symptoms'],[],[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],,0.0982499,,"[{'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Gibson', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, CA; Department of Psychiatry, University of California, San Francisco, CA. Electronic address: Carolyn.Gibson2@va.gov.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Larson', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN; Department of Medicine, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'LaCroix', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, CA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.270'] 833,30547820,"Lipid levels, insulin resistance and cardiovascular risk over 96 weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir.","BACKGROUND HIV infection and antiretroviral treatment are associated with changes in lipid levels, insulin resistance and risk of cardiovascular disease (CVD). We investigated these changes in the first 96 weeks of treatment with low-dose stavudine or tenofovir regimens. METHODS This is a secondary analysis of a double blind, randomised controlled trial performed in South-Africa, Uganda and India comparing low-dose stavudine (20 mg twice daily) with tenofovir in combination with efavirenz and lamivudine in antiretroviral-naïve adults (n = 1067) (Clinicaltrials.gov, NCT02670772). Over 96 weeks, data were collected on fasting lipids, glucose and insulin. Insulin resistance was assessed with the HOMA-IR index and 10-year CVD risk with the Framingham risk score (FRS). A generalized linear mixed model was used to estimate trends over time. RESULTS Participants were on average 35.3 years old, 57.6% female and 91.8% Black African. All lipid levels increased following treatment initiation, with the sharpest increase in the first 24 weeks of treatment. The increase in all lipid subcomponents over 96 weeks was higher among those in the stavudine than the tenofovir group. Insulin resistance increased steadily with no difference detected between study groups. FRS rose from 1.90% (1.84-1.98%) at baseline to 2.06 (1.98-2.15%) at week 96 for the total group, with no difference between treatment arms (p = 0.144). Lipid changes were more marked in Indian than African participants. CONCLUSION Lipid levels increased in both groups, with low-dose stavudine resulting in a worse lipid profile compared to tenofovir. Insulin resistance increased, with no difference between regimens. CVD risk increased over time and tended to increase more in the group on stavudine. The low CVD risk across both arms argues against routine lipid and glucose monitoring in the absence of other CVD risk factors. In high risk patients, monitoring may only be appropriate at least a year after treatment initiation.",2018,"Lipid levels increased in both groups, with low-dose stavudine resulting in a worse lipid profile compared to tenofovir.","['antiretroviral-naïve adults (n\u2009=\u20091067', 'Participants were on average 35.3\xa0years old, 57.6% female and 91.8% Black African']","['efavirenz and lamivudine', 'tenofovir', 'stavudine and tenofovir', 'stavudine or tenofovir', 'antiretroviral therapy', 'stavudine']","['all lipid subcomponents', 'Lipid levels', 'lipid levels, insulin resistance and risk of cardiovascular disease (CVD', 'HOMA-IR index and 10-year CVD risk with the Framingham risk score (FRS', 'Lipid levels, insulin resistance and cardiovascular risk', 'Insulin resistance', 'fasting lipids, glucose and insulin', 'Lipid changes', 'FRS', 'CVD risk', 'All lipid levels']","[{'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337824', 'cui_str': 'Black African (ethnic group)'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0164662', 'cui_str': 'Stavudine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.145524,"Lipid levels increased in both groups, with low-dose stavudine resulting in a worse lipid profile compared to tenofovir.","[{'ForeName': 'Alinda G', 'Initials': 'AG', 'LastName': 'Vos', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. avos@wrhi.ac.za.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Chersich', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Klipstein-Grobusch', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Moorhouse', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Samanta T', 'Initials': 'ST', 'LastName': 'Lalla-Edward', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kambugu', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'YRGCARE Medical Centre, CART Clinical Research Site, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Roos E', 'Initials': 'RE', 'LastName': 'Barth', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Willem D', 'Initials': 'WD', 'LastName': 'Venter', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}]",Retrovirology,['10.1186/s12977-018-0460-z'] 834,32143986,Randomized trial of a patient education tool about leiomyoma.,"OBJECTIVE Uterine leiomyomata are a frequent indication for women seeking gynecologic care [1]. The objective of our study was to assess whether patient knowledge about leiomyomata, anxiety, or satisfaction with counseling differed in patients who received multimedia counseling versus standard counseling. METHODS Women with leiomyomata who presented to the gynecology clinic at a single institution were randomized to standard counseling or multimedia counseling using the drawMD OB/GYN iPad™ application. Participants completed a pre-counseling questionnaire, received the designated method of counseling, and completed a post-counseling questionnaire. Outcomes of the study included assessment of patient knowledge, satisfaction, and anxiety. RESULTS Seventy-two participants were randomized. There was no significant difference in post-counseling anxiety between the groups (p = 0.86). For both groups, anxiety significantly improved after counseling. Both groups were satisfied with the counseling they received, however, there was no difference between groups. Participants in both groups significantly improved their knowledge about fibroids post-counseling. CONCLUSION Counseling of patients with leiomyomata improves patient satisfaction and knowledge. The addition of a multimedia tool may or may not enhance patient counseling. PRACTICE IMPLICATIONS This is the first prospective, randomized controlled trial evaluating the impact of a multimedia tool on patient education and counseling for patients with leiomyomata.",2020,There was no significant difference in post-counseling anxiety between the groups (p = 0.86).,"['Women with leiomyomata who presented to the gynecology clinic at a single institution', 'patients with', 'Seventy-two participants were randomized', 'patients with leiomyomata']","['leiomyomata', 'multimedia counseling versus standard counseling', 'patient education tool about leiomyoma', 'standard counseling or multimedia counseling using the drawMD OB/GYN iPad™ application']","['anxiety', 'patient knowledge about leiomyomata, anxiety, or satisfaction with counseling', 'knowledge about fibroids post-counseling', 'patient satisfaction and knowledge', 'patient knowledge, satisfaction, and anxiety', 'post-counseling anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",72.0,0.111555,There was no significant difference in post-counseling anxiety between the groups (p = 0.86).,"[{'ForeName': 'Prerna R', 'Initials': 'PR', 'LastName': 'Pandya', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA. Electronic address: prernaraj@gmail.com.'}, {'ForeName': 'Rebecka B', 'Initials': 'RB', 'LastName': 'Docken', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Nicole O', 'Initials': 'NO', 'LastName': 'Sonn', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Dara P', 'Initials': 'DP', 'LastName': 'Matthew', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Sung', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tsambarlis', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.031'] 835,29603407,Nutrition Support Team Guide to Maternal Diet for the Human-Milk-Fed Infant.,"BACKGROUND Human milk feeding is encouraged for all infants; however, the mammary gland depends on maternal dietary intake of vitamins A, B1, B2, B6, B12, D, docosahexaenoic acid (DHA), choline, and iodine. Nutrition support team knowledge of maternal feeding guidelines for these nutrient sources can therefore impact infant intake. We hypothesized that these key nutrients for lactation in the mother's diet would be less than the dietary guidelines in the United States. METHODS This was a secondary analysis of nutrition data collected during a randomized, controlled trial. Dietary records were analyzed from 16 mothers (13 with singleton and 3 with multiple births) completing the study. Mean dietary intakes of selected nutrients were calculated and compared with the current dietary reference intakes. RESULTS Mean maternal dietary intake for singletons was significantly (P < .05) lower than the dietary reference intakes for (vitamin A (58%), vitamin D (44%), and choline (58%);) DHA comprised only 5% of the current expert recommendation. Based on singleton recommendations, mothers to twins consumed an adequate intake except for DHA. CONCLUSIONS Women providing breast milk for singleton preterm infants did not consume dietary reference intakes for key nutrients. Twin mothers' diets were adequate except for DHA, but these guidelines are based on singleton pregnancies and remain poorly understood for twin needs. The nutrition support team can have a unique role in maternal dietary education to impact human milk nutrient delivery to the infant.",2018,"Mean maternal dietary intake for singletons was significantly (P < .05) lower than the dietary reference intakes for (vitamin A (58%), vitamin D (44%), and choline (58%);) DHA comprised only 5% of the current expert recommendation.","['16 mothers (13 with singleton and 3 with multiple births) completing the study', 'singleton preterm infants', ""Twin mothers' diets""]",[],"['Mean dietary intakes of selected nutrients', 'Mean maternal dietary intake for singletons']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2015861', 'cui_str': 'Multiple birth (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.0524316,"Mean maternal dietary intake for singletons was significantly (P < .05) lower than the dietary reference intakes for (vitamin A (58%), vitamin D (44%), and choline (58%);) DHA comprised only 5% of the current expert recommendation.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Copp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'DeFranco', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Kleiman', 'Affiliation': ""Department of Infectious Diseases, Cincinnati Children's Hospital, Cincinnati, Ohio, USA.""}, {'ForeName': 'Lynette K', 'Initials': 'LK', 'LastName': 'Rogers', 'Affiliation': ""Center for Perinatal Research, Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Ardythe L', 'Initials': 'AL', 'LastName': 'Morrow', 'Affiliation': ""Cincinnati Children's Hospital, Division of Neonatology, Cincinnati, Ohio, USA.""}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Valentine', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10071'] 836,31923061,Ropivacaine and Ketorolac Wound Infusion for Post-Cesarean Delivery Analgesia: A Randomized Controlled Trial.,"OBJECTIVE To evaluate the efficacy of wound infusion with ropivacaine plus ketorolac compared with placebo for post-cesarean delivery analgesia in women who received a multimodal analgesic regimen including intrathecal morphine. METHODS In a randomized double-blind study, women undergoing scheduled cesarean delivery under spinal or combined spinal epidural anesthesia were randomized to wound infusion with ropivacaine 0.2% plus ketorolac, or saline placebo using an elastometric pump for 48 hours. The primary outcome was pain score with movement at 24 hours after surgery (0-10 scale, 0=no pain and 10=worst possible pain). Secondary outcomes included pain scores at rest at 24 hours, pain scores at rest and with movement at 2 and 48 hours, opioid consumption, and time to first rescue analgesic. A sample size of 35 per group (n=70) was planned. RESULTS From November 8, 2016, to May 17, 2019, 247 women were screened, and 71 completed the study per protocol: 38 in the placebo group and 33 in the ropivacaine plus ketorolac group. Patient demographics and intraoperative characteristics were comparable between the groups. There was no significant difference between the groups in the primary outcome of pain score with movement at 24 hours (difference in median score 0, 95% CI -1 to 2, P=.94). There were also no significant differences between the placebo and ropivacaine plus ketorolac groups in pain scores at other time points, in total opioid consumption (difference in median consumption -12.5 mg, 95% CI -30 to 5, P=.11), or in time to rescue analgesics (median [interquartile range] 660 [9-1,496] vs 954 [244-1,710] minutes, hazard ratio 0.69, 95% CI 0.41 to 1.17, P=.16). CONCLUSION There was no benefit of wound infusion with ropivacaine and ketorolac in women who received intrathecal morphine and a multimodal analgesic regimen. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02829944. FUNDING SOURCE The study was supported in part by Avanos Medical Inc.",2020,"There were also no significant differences between the placebo and ropivacaine plus ketorolac groups in pain scores at other time points, in total opioid consumption (difference in median consumption -12.5 mg, 95% CI -30 to 5, P=.11), or in time to rescue analgesics (median [interquartile range] 660 [9-1,496] vs 954 [244-1,710] minutes, hazard ratio 0.69, 95% CI 0.41 to 1.17, P=.16). ","['women who received a multimodal analgesic regimen including intrathecal morphine', 'Post-Cesarean Delivery Analgesia', 'women undergoing scheduled cesarean delivery under spinal or combined spinal epidural anesthesia', 'From November 8, 2016, to May 17, 2019, 247 women were screened, and 71 completed the study per protocol: 38 in the placebo group and 33 in the']","['Ropivacaine', 'ropivacaine 0.2% plus ketorolac, or saline placebo', 'intrathecal morphine', 'placebo', 'ketorolac', 'ropivacaine', 'Ketorolac Wound Infusion', 'ropivacaine plus ketorolac']","['pain scores', 'total opioid consumption', 'pain score', 'pain scores at rest at 24 hours, pain scores at rest and with movement at 2 and 48 hours, opioid consumption, and time to first rescue analgesic', 'pain score with movement at 24 hours after surgery (0-10 scale, 0=no pain and 10=worst possible pain', 'time to rescue analgesics', 'Patient demographics and intraoperative characteristics']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0222045'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",247.0,0.785805,"There were also no significant differences between the placebo and ropivacaine plus ketorolac groups in pain scores at other time points, in total opioid consumption (difference in median consumption -12.5 mg, 95% CI -30 to 5, P=.11), or in time to rescue analgesics (median [interquartile range] 660 [9-1,496] vs 954 [244-1,710] minutes, hazard ratio 0.69, 95% CI 0.41 to 1.17, P=.16). ","[{'ForeName': 'Emily Z', 'Initials': 'EZ', 'LastName': 'Barney', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina; the Anesthesia Medical Group, Inc., Nashville, Tennessee; and the Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Pedro', 'Affiliation': ''}, {'ForeName': 'Brock H', 'Initials': 'BH', 'LastName': 'Gamez', 'Affiliation': ''}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Fuller', 'Affiliation': ''}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Dominguez', 'Affiliation': ''}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Habib', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003601'] 837,31923066,Effect of Surgery for Stress Incontinence on Female Sexual Function.,"OBJECTIVE To evaluate the effects of four different surgical interventions for stress urinary incontinence (SUI) on 2-year postoperative sexual function. METHODS This is a combined secondary analysis of SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings). Women in the original trials were randomized to receive surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function (assessed by the short version of the PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire]) was compared between groups at baseline, 12 and 24 months. Secondarily, the effects of subjective and objective surgical cure rates and the effect of concomitant surgical procedures on 24-month sexual function was explored. RESULTS Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed. Baseline characteristics (including PISQ-12 scores) were similar between the four treatment arms, with notable exceptions including race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries. After adjustment for differences between the groups, there was a clinically important improvement in PISQ-12 scores over the 24-month postoperative period for all treatment groups, with no significant differences attributed to the type of anti-incontinence procedure (baseline PISQ-12: 32.6, 33.1, 31.9, 31.4; 24-month PISQ-12: 37.7, 37.8, 36.9, 37.1, P<.01). There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97). Multivariable analysis showed independent associations between objective and subjective cure rates as well as concomitant procedures with a 24-month PISQ-12 score. CONCLUSION Women undergoing anti-incontinence surgery show overall improvement in sexual function from baseline to 24 months postoperatively, without significant differences based on surgical procedure performed. The majority of this improvement occurs in the first 12 months and is maintained over 24 months.",2020,"There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97).","['Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed', 'Stress Incontinence on Female Sexual Function']","['surgical interventions', 'TOMUS', 'surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS', 'Surgery', 'concomitant surgical procedures']","['mean PISQ-12 scores', 'Sexual function', 'PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire', 'objective and subjective cure rates', 'Baseline characteristics (including PISQ-12 scores', 'PISQ-12 scores', 'type of anti-incontinence procedure', 'race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries', 'sexual function', '24-month sexual function']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0563527', 'cui_str': 'Colposuspension (procedure)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}]","[{'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0563527', 'cui_str': 'Colposuspension (procedure)'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",924.0,0.049267,"There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Glass Clark', 'Affiliation': 'Department of Obstetrics and Gynecology and the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Virginia Commonwealth University Health System, and the Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Sima', 'Affiliation': ''}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Siff', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003648'] 838,31923073,Perineorrhaphy Compared With Pelvic Floor Muscle Therapy in Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear: A Randomized Controlled Trial.,"OBJECTIVE To evaluate outcomes after pelvic floor muscle therapy, as compared with perineorrhaphy and distal posterior colporrhaphy, in the treatment of women with a poorly healed second-degree obstetric injury diagnosed at least 6 months postpartum. METHODS We performed a single center, open-label, randomized controlled trial. After informed consent, patients with a poorly healed second-degree perineal tear at minimum 6 months postpartum were randomized to either surgery or physical therapy. The primary outcome was treatment success, as defined by Patient Global Impression of Improvement, at 6 months. Secondary outcomes included the Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the Hospital Anxiety and Depression Scale. Assuming a 60% treatment success in the surgery group and 20% in the physical therapy group, plus anticipating a 20% loss to follow-up, a total of 70 patients needed to be recruited. RESULTS From October 2015 to June 2018, 70 of 109 eligible patients were randomized, half into surgery and half into tutored pelvic floor muscle therapy. The median age of the study group was 35 years, and the median duration postpartum at enrollment in the study was 10 months. There were three dropouts in the surgery group postrandomization. In an intention-to-treat analysis, with worst case imputation of missing outcomes, subjective global improvement was reported by 25 of 35 patients (71%) in the surgery group compared with 4 of 35 patients (11%) in the physical therapy group (treatment effect in percentage points 60% [95% CI 42-78%], odds ratio 19 [95% CI 5-69]). The surgery group was superior to physical therapy regarding all secondary endpoints. CONCLUSION Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02545218.",2020,"Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum. ","['From October 2015 to June 2018, 70 of 109 eligible patients', 'Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear', 'patients with a poorly healed second-degree perineal tear at minimum 6 months postpartum', 'women with a poorly healed second-degree obstetric injury diagnosed at least 6 months postpartum']","['surgery or physical therapy', 'Pelvic Floor Muscle Therapy', 'pelvic floor muscle therapy', 'pelvic floor muscle training', 'perineorrhaphy and distal posterior colporrhaphy', 'Perineorrhaphy']","['treatment success, as defined by Patient Global Impression of Improvement', 'subjective global improvement', 'median duration postpartum', 'Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the Hospital Anxiety and Depression Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205169', 'cui_str': 'Bad (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0031064', 'cui_str': 'Perineorrhaphy (procedure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina (procedure)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}]",109.0,0.139692,"Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum. ","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Bergman', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and the Division of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Westergren Söderberg', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ek', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003653'] 839,31923074,Lidocaine-Prilocaine Cream Compared With Injected Lidocaine for Vulvar Biopsy: A Randomized Controlled Trial.,"OBJECTIVE To compare pain control during vulvar biopsy after either application of 5% lidocaine-prilocaine cream or injection of 1% lidocaine. METHODS In a single-site randomized trial, patients who needed vulvar biopsy on a non-hair-bearing surface were recruited from a gynecologic oncology clinic to compare lidocaine-prilocaine cream (placed at least 10 minutes before biopsy) with lidocaine injection (at least 1 minute prior). A sample size of 53 participants in each arm (N=106) was planned. Pain was recorded using a 100 mm visual analog scale at three time points: baseline, after application of anesthesia, and after biopsy. The primary outcome was highest pain score recorded. Secondary outcomes were pain score at biopsy, patient experience, and tolerability and acceptability. Linear regression was used to compare the primary outcome between arms while controlling for baseline vulvar pain. A convenience analysis was performed in March 2019. RESULTS From October 2018 to March 2019, 38 patients completed informed consent and were randomized. Participants were women with median age of 60 years. Most characteristics between groups were similar. Nineteen were analyzed in the lidocaine-prilocaine group, and 18 were analyzed in the lidocaine injection group. The median highest pain score in the lidocaine-prilocaine group was 20.0 mm vs 56.5 mm in the lidocaine injection group. Controlling for baseline pain, the highest pain score in the lidocaine-prilocaine arm was 25.7 mm lower than in the lidocaine injection arm (95% CI [-45.1 to -6.3]; P<.01). Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). CONCLUSION Lidocaine-prilocaine cream before vulvar biopsy resulted in a lower maximum pain score and a significantly better patient rating of the biopsy experience when compared with lidocaine injection. Lidocaine-prilocaine cream, alone, is a reasonable option to use for vulvar biopsy. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03654417.",2020,"Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). ","['patients who needed vulvar biopsy on a non-hair-bearing surface were recruited from a gynecologic oncology clinic to compare', 'From October 2018 to March 2019, 38 patients completed informed consent and were randomized', 'Vulvar Biopsy', 'Participants were women with median age of 60 years', '53 participants in each arm (N=106) was planned']","['lidocaine-prilocaine cream or injection of 1% lidocaine', 'lidocaine-prilocaine', 'lidocaine injection', 'Lidocaine-Prilocaine Cream', 'lidocaine-prilocaine cream', 'Lidocaine', 'lidocaine', 'Lidocaine-prilocaine cream']","['Pain', 'pain score at biopsy, patient experience, and tolerability and acceptability', 'median highest pain score', 'maximum pain score', 'highest pain score', 'baseline vulvar pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1744618', 'cui_str': 'Biopsy of vulva (procedure)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0617623', 'cui_str': 'Lidocaine / Prilocaine'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4081145', 'cui_str': 'Lidocaine Injection [Xylocaine]'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",53.0,0.27322,"Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). ","[{'ForeName': 'Logan K', 'Initials': 'LK', 'LastName': 'Williams', 'Affiliation': 'Department of Obstetrics and Gynecology, and Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, and the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': ''}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Lorenzo', 'Affiliation': ''}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Havrilesky', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003660'] 840,31975520,Emotional regulation training for intensive and critical care nurses.,"Professional quality of life is related to psychological well-being for nurses with implications for quality patient care. This study evaluated the effectiveness of emotional regulation training on depression, anxiety and stress, and professional quality of life for intensive and critical care nurses. In this experimental comparison trial, 60 intensive and critical care nurses were randomly assigned to treatment and wait-list control groups. The treatment group received six sessions of emotional regulation training, while the wait-list control group received no treatment. Outcome measures were: the Cognitive Emotion Regulation Questionnaire; the Depression, Anxiety and Stress Scale; and the Professional Quality of Life Scale in a pre-post design. The treatment group demonstrated greater improvements in burnout and compassion satisfaction compared with the wait-list control group. No significant reduction in compassion fatigue was found compared with controls. Some cognitive coping strategies improved in the treatment group compared with controls, with greater reductions in depression, anxiety, and stress. This study indicates the benefits of implementing emotional regulation training programs to improve psychological well-being and professional quality of life for intensive and critical care nurses.",2020,"Some cognitive coping strategies improved in the treatment group compared with controls, with greater reductions in depression, anxiety, and stress.","['intensive and critical care nurses', '60 intensive and critical care nurses']","['implementing emotional regulation training programs', 'six sessions of emotional regulation training, while the wait-list control group received no treatment', 'emotional regulation training', 'Emotional regulation training']","['depression, anxiety, and stress', 'compassion fatigue', 'depression, anxiety and stress, and professional quality of life', 'Cognitive Emotion Regulation Questionnaire; the Depression, Anxiety and Stress Scale; and the Professional Quality of Life Scale', 'cognitive coping strategies', 'burnout and compassion satisfaction', 'Professional quality of life']","[{'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0034380'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",60.0,0.0273817,"Some cognitive coping strategies improved in the treatment group compared with controls, with greater reductions in depression, anxiety, and stress.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Kharatzadeh', 'Affiliation': 'Department of Clinical Psychology, Faculty of Human Sciences, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mousa', 'Initials': 'M', 'LastName': 'Alavi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Visentin', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cleary', 'Affiliation': 'School of Nursing, College of Health and Medicine, University of Tasmania, Sydney, New South Wales, Australia.'}]",Nursing & health sciences,['10.1111/nhs.12679'] 841,31922265,Primary HPV testing with cytology versus cytology alone in cervical screening-A prospective randomized controlled trial with two rounds of screening in a Chinese population.,"We conducted a prospective randomized controlled trial with two screening rounds to evaluate the effectiveness of combining HPV testing with liquid-based cytology (LBC) as a co-test, compared to LBC only in cervical cancer screening of a Chinese population. First, 15,955 women aged 30-60 were randomized at a 1:1 ratio into an intervention group (Digene Hybrid Capture 2 HPV test with LBC) and a control group (LBC alone). Women in the intervention group would be referred for colposcopy and biopsy immediately if they were found to have high-risk HPV regardless of cytology results. The detection of cervical intraepithelial neoplasia grade 2 or above (CIN2+) lesions was significantly higher in the intervention group compared to the control (0.95% vs. 0.38%, OR 2.50, 95% CI 1.65-3.88). At the subsequent round of screening approximately 36 months later, CIN2+ detection was significantly lower in the intervention group (0.08% vs. 0.35%, OR 0.23, 95% CI 0.08-0.57). Over the two rounds of screening, the total detection of CIN2+ was higher in the intervention group (1.01% vs. 0.66%, OR 1.53, 95% CI 1.09-2.19). There was a fourfold increase (10.6% vs. 2.4%, p < 0.001) in the number of colposcopies performed in the intervention arm. Adding a high-risk HPV test to cytology for primary cervical screening led to earlier detection of clinically significant preinvasive lesions, resulting in a reduced detection of CIN2+ lesions in subsequent rounds and an increased rate of colposcopy.",2020,"The detection of cervical intraepithelial neoplasia grade 2 or above (CIN2+) lesions was significantly higher in the intervention group compared to the control (0.95% vs 0.38%, OR 2.50, 95% CI 1.65-3.88).","['cervical cancer screening of a Chinese population', 'Chinese population', '15,955 women aged 30-60']","['intervention group (Digene Hybrid Capture 2 HPV test with LBC) and a control group (LBC alone', 'Primary HPV testing with cytology versus cytology alone', 'HPV testing with liquid-based cytology (LBC']","['rate of colposcopy', 'detection of cervical intraepithelial neoplasia grade 2 or above (CIN2+) lesions', 'CIN2+ detection', 'total detection of CIN2']","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2 (disorder)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",60.0,0.155635,"The detection of cervical intraepithelial neoplasia grade 2 or above (CIN2+) lesions was significantly higher in the intervention group compared to the control (0.95% vs 0.38%, OR 2.50, 95% CI 1.65-3.88).","[{'ForeName': 'Karen K L', 'Initials': 'KKL', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Siew F', 'Initials': 'SF', 'LastName': 'Ngu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Mandy M Y', 'Initials': 'MMY', 'LastName': 'Chu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Ka Y', 'Initials': 'KY', 'LastName': 'Tse', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Lesley S K', 'Initials': 'LSK', 'LastName': 'Lau', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Annie N Y', 'Initials': 'ANY', 'LastName': 'Cheung', 'Affiliation': 'Department of Pathology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Hextan Y S', 'Initials': 'HYS', 'LastName': 'Ngan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.'}]",International journal of cancer,['10.1002/ijc.32861'] 842,31905331,Practitioner Education and Feedback to Decrease Ciprofloxacin Prescriptions in Patients with Acute Uncomplicated Cystitis.,"CONTEXT Current guidelines recommend a nonfluoroquinolone agent as first-line treatment of acute uncomplicated cystitis (AUC) because of concerns of antimicrobial resistance and adverse effects. OBJECTIVE To test whether a multifaceted intervention involving education and feedback reduced primary care practitioners' ciprofloxacin prescriptions for AUC therapy. DESIGN Primary care practitioners at 3 medical offices participated: 65 in the intervention group and 51 in the control group. Intervention group participants received an educational lecture and emailed summary of antimicrobial guidelines, their AUC prescriptions were audited, and feedback was provided on inappropriate antibiotic choices. Prescriptions at AUC encounters were tracked during baseline, intervention, and postintervention periods. MAIN OUTCOME MEASURES Proportion of AUC encounters at which ciprofloxacin was prescribed vs recommended first-line antibiotics. RESULTS Intervention group participants had 5262 eligible AUC encounters, and control group participants had 5473. At baseline, ciprofloxacin was prescribed at 29.7% and 33.7% of eligible AUC encounters in the intervention and control groups, respectively (p = 0.003). After intervention, ciprofloxacin was prescribed at 10.8% of eligible AUC encounters in the intervention group and 34.3% in the control (p < 0.001). Adjusted odds ratios of ciprofloxacin prescription for AUC therapy were significantly lower in the intervention group during postintervention and intervention periods vs baseline (0.29, 95% confidence interval = 0.20-0.44, p < 0.001 and 0.80, 95% confidence interval = 0.66-0.97, p = 0.03). Adjusted odds ratios did not change over time in the controls. CONCLUSION Educating primary care practitioners and conducting audit and feedback reduced their prescriptions of ciprofloxacin for AUC therapy.",2020,"Adjusted odds ratios of ciprofloxacin prescription for AUC therapy were significantly lower in the intervention group during postintervention and intervention periods vs baseline (0.29, 95% confidence interval = 0.20-0.44, p < 0.001 and 0.80, 95% confidence interval = 0.66-0.97, p = 0.03).","['Intervention group participants had 5262 eligible AUC encounters, and control group participants had 5473', 'Patients with Acute Uncomplicated Cystitis', 'Primary care practitioners at 3 medical offices participated: 65 in the intervention group and 51 in the control group']","['ciprofloxacin', 'Ciprofloxacin Prescriptions', ""multifaceted intervention involving education and feedback reduced primary care practitioners' ciprofloxacin prescriptions"", 'educational lecture and emailed summary of antimicrobial guidelines, their AUC prescriptions were audited, and feedback was provided on inappropriate antibiotic choices', 'ciprofloxacin for AUC therapy']",['Adjusted odds ratios of ciprofloxacin prescription for AUC therapy'],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.10024,"Adjusted odds ratios of ciprofloxacin prescription for AUC therapy were significantly lower in the intervention group during postintervention and intervention periods vs baseline (0.29, 95% confidence interval = 0.20-0.44, p < 0.001 and 0.80, 95% confidence interval = 0.66-0.97, p = 0.03).","[{'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Guo', 'Affiliation': 'Department of Hospital Medicine, Kaiser Permanente Northwest, Portland, OR.'}, {'ForeName': 'Dinh L', 'Initials': 'DL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Family Medicine, Kaiser Permanente San Diego Medical Center, CA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kaiser Permanente Los Angeles Medical Center, CA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nguyen', 'Affiliation': 'HealthCare Partners, Long Beach, CA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ko', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Vicki Y', 'Initials': 'VY', 'LastName': 'Chiu', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Dickter', 'Affiliation': 'Division of Infectious Diseases, City of Hope, Duarte, CA.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Becker', 'Affiliation': 'Department of Graduate Medical Education, Kaiser Permanente, Pasadena, CA.'}, {'ForeName': 'Philomena', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kaiser Permanente Fontana Medical Center, CA.'}]",The Permanente journal,['10.7812/TPP/18.036'] 843,31981556,Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial.,"BACKGROUND Innovative solutions are required to provide mental health support at scale in low-resource humanitarian contexts. We aimed to assess the effectiveness of a facilitator-guided, group-based, self-help intervention (Self-Help Plus) to reduce psychological distress in female refugees. METHODS We did a cluster randomised trial in rural refugee settlements in northern Uganda. Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6). The intervention comprised access to usual care and five 2-h audio-recorded stress-management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book. Villages were randomly assigned to either intervention (Self-Help Plus or enhanced usual care) on a 1:1 basis. Within 14 villages, randomly selected households were approached. Screening of women in households continued until 20-30 eligible participants were identified per site. The primary outcome was individual psychological distress, assessed using the Kessler 6 symptom checklist 1 week before, 1 week after, and 3 months after intervention, in the intention-to-treat population. All outcomes were measured at the individual (rather than cluster) level. Secondary outcomes included personally identified problems, post-traumatic stress, depression symptoms, feelings of anger, social interactions with other ethnic groups, functional impairment, and subjective wellbeing. Assessors were masked to allocation. This trial was prospectively registered at ISRCTN, number 50148022. FINDINGS Of 694 eligible participants (331 Self-Help Plus, 363 enhanced usual care), 613 (88%) completed all assessments. Compared with controls, we found stronger improvements for Self-Help Plus on psychological distress 3 months post intervention (β -1·20, 95% CI -2·33 to -0·08; p=0·04; d -0·26). We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36). Refugees with different trauma exposure, length of time in settlements, and initial psychological distress benefited similarly. With regard to safety considerations, the independent data safety management board responded to six adverse events, and none were evaluated to be concerns in response to the intervention. INTERPRETATION Self-Help Plus is an innovative, facilitator-guided, group-based self-help intervention that can be rapidly deployed to large numbers of participants, and resulted in meaningful reductions in psychological distress at 3 months among South Sudanese female refugees. FUNDING Research for Health in Humanitarian Crises (R2HC) Programme.",2020,We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36).,"['female refugees', 'South Sudanese female refugees in Uganda', 'Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6', 'women in households continued until 20-30 eligible participants', 'rural refugee settlements in northern Uganda', '694 eligible participants (331 Self-Help Plus']","['facilitator-guided, group-based, self-help intervention (Self-Help Plus', 'Self-Help', 'usual care and five 2-h audio-recorded stress-management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book', 'intervention (Self-Help Plus or enhanced usual care']","['personally identified problems, post-traumatic stress, depression symptoms, feelings of anger, social interactions with other ethnic groups, functional impairment, and subjective wellbeing', 'psychological distress', 'individual psychological distress, assessed using the Kessler 6 symptom checklist', 'length of time in settlements, and initial psychological distress']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0241297', 'cui_str': 'Sudanese (ethnic group)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0006002', 'cui_str': 'Books'}]","[{'cui': 'C0683510', 'cui_str': 'Identifying problems (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",694.0,0.0951295,We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36).,"[{'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Peter C Alderman Program for Global Mental Health, HealthRight International, New York, NY, USA. Electronic address: wtol@jhu.edu.'}, {'ForeName': 'Marx R', 'Initials': 'MR', 'LastName': 'Leku', 'Affiliation': 'Arua, Uganda.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Lakin', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Carswell', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Jura', 'Initials': 'J', 'LastName': 'Augustinavicius', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Adaku', 'Affiliation': 'Arua, Uganda; Department of Psychiatry, Arua Regional Referral Hospital, Arua, Uganda.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Au', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Brown', 'Affiliation': 'WarChild Holland, Amsterdam, Netherlands.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Garcia-Moreno', 'Affiliation': 'Department of Reproductive Health & Research, WHO, Geneva, Switzerland.'}, {'ForeName': 'Rashelle J', 'Initials': 'RJ', 'LastName': 'Musci', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section, UN High Commissioner for Refugees, Geneva, Switzerland.'}, {'ForeName': 'Ross G', 'Initials': 'RG', 'LastName': 'White', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30504-2'] 844,31981558,Cause-specific mortality of children younger than 5 years in communities receiving biannual mass azithromycin treatment in Niger: verbal autopsy results from a cluster-randomised controlled trial.,"BACKGROUND The Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial found that biannual mass distribution of azithromycin to children younger than 5 years in Niger reduced the primary outcome of all-cause mortality by 18%. We aimed to determine the causes of mortality among deceased children using verbal autopsy. METHODS In this 2-year cluster-randomised controlled trial, 594 community clusters in Niger were randomly allocated (1:1 ratio) to receive biannual mass distributions of either oral azithromycin (approximately 20 mg per kg of bodyweight) or placebo targeted to children aged 1-59 months. Participants, study investigators, and field workers were masked to treatment allocation. Between Nov 23, 2014, and July 31, 2017, 3615 child deaths were recorded by use of biannual house-to-house censuses, and verbal autopsies were done between May 26, 2015, and May 17, 2018, to identify cause of death. Cause-specific mortality, as assessed by verbal autopsy, was a prespecified secondary outcome. This trial is completed and is registered with ClinicalTrials.gov, NCT02047981. FINDINGS Between Nov 23, 2014, and July 31, 2017, 303 communities (n=40 375 children at baseline) in Niger received mass azithromycin and 291 communities (n=35 747 children at baseline) received placebo. Treatment coverage was 90·3% (SD 10·6) in the azithromycin group and 90·4% (10·1) in the placebo group. No communities were lost to follow-up. In total, 1727 child deaths in the azithromycin group and 1888 child deaths in the placebo group were reported from the population censuses. Of these, the cause of death for 1566 (90·7%) children in the azithromycin group and 1735 (91·9%) children in the placebo group were ascertained by verbal autopsy interviews. In the azithromycin group, 437 (27·9%) deaths were due to malaria, 252 (16·1%) deaths were due to pneumonia, and 234 (14·9%) deaths were due to diarrhoea. In the placebo group, 493 (28·4%) deaths were due to malaria, 275 (15·9%) deaths were due to pneumonia, and 251 (14·5%) deaths were due to diarrhoea. Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051). The distribution of causes of death did not differ significantly between the two study groups (p=0·98). INTERPRETATION Mass azithromycin distribution resulted in approximately a third fewer deaths in children aged 1-59 months due to meningitis and dysentery, and a fifth fewer deaths due to malaria and pneumonia. The lack of difference in the distribution of causes of death between the azithromycin and placebo groups could be attributable to the broad spectrum of azithromycin activity and the study setting, in which most childhood deaths were due to infections. FUNDING Bill & Melinda Gates Foundation.",2020,"Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051).","['deceased children using verbal autopsy', 'Between Nov 23, 2014, and July 31, 2017, 3615 child deaths', '594 community clusters in Niger', 'Between Nov 23, 2014, and July 31, 2017', ' 303 communities (n=40\u2008375 children at baseline) in Niger received mass', 'children younger than 5 years in communities receiving', 'and 291 communities (n=35\u2008747 children at baseline) received']","['oral azithromycin', 'placebo', 'azithromycin', 'biannual mass azithromycin']","['distribution of causes of death', 'Cause-specific mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0004398', 'cui_str': 'Postmortem Examination'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",594.0,0.47897,"Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA. Electronic address: jeremy.keenan@ucsf.edu.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Sanoussi', 'Initials': 'S', 'LastName': 'Elh Adamou', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ibrahim', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Mariama', 'Initials': 'M', 'LastName': 'Kiemago', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nana Fatima', 'Initials': 'NF', 'LastName': 'Galo', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Vanderschelden', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30540-6'] 845,31978010,Efficacy and Safety of Sodium Benzoate in The Management of Hyperammonemia in Decompensated Chronic Liver Disease of the Childhood-A Double-blind Randomized Controlled Trial.,"OBJECTIVE The objective was to evaluate the efficacy and safety of sodium benzoate in the management of hyperammonemia and hepatic encephalopathy (HE) in decompensated chronic liver disease. METHODS It was a prospective, interventional, double-blinded randomized controlled trial conducted from August 2017 to December 2018. Children with decompensated chronic liver disease and hyperammonemia were included in the study. Those with ammonia >400 μg/dL, already receiving sodium benzoate or with grade III ascites were excluded. Group A received sodium benzoate (400 mg/kg loading dose followed by 200 mg · kg · daymaintenance for 5 days) along with the standard medical therapy. Group B received standard medical therapy with placebo. RESULTS A total of 108 episodes of hyperammonemia occurred in 86 patients of whom 16 were excluded. The final analysis included 46 episodes in each group. The median decrease in ammonia from baseline to day 5 was 52 μg/dL in group A versus 42 μg/dL in group B (P = 0.321). There was a significant decrease in ammonia on days 1 and 2 in group A as compared to group B, but not on subsequent days. There was no significant difference in the resolution of HE (57.1% vs 50%; P = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%). CONCLUSIONS Addition of sodium benzoate significantly reduced the ammonia levels on the first 2 days of therapy but the effect was not sustained till day 5. The effect of sodium benzoate would probably be more sustained, if higher dosage (400 mg · kg · day) could be used under monitoring of benzoate levels. There was no effect on resolution of HE. Sodium benzoate caused an increasing trend of adverse events with no effect on short-term survival.",2020,"There was no significant difference in the resolution of HE (57.1% vs 50%; P = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%). ","['August 2017 to December 2018', 'A total of 108 episodes of hyperammonemia occurred in 86 patients of whom 16 were excluded', 'Children with decompensated chronic liver disease and hyperammonemia', 'decompensated chronic liver disease']","['sodium benzoate', 'sodium benzoate (400\u200amg/kg loading dose followed by 200\u200amg\u200a·\u200akg\u200a·\u200adaymaintenance for 5 days) along with the standard medical therapy', 'standard medical therapy with placebo', 'Sodium Benzoate']","['ammonia', 'Efficacy and Safety', 'resolution of HE', 'ammonia levels', 'median decrease in ammonia', 'adverse events', 'ascites']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0220994', 'cui_str': 'Hyperammonemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}]","[{'cui': 'C0142805', 'cui_str': 'Sodium Benzoate'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201879', 'cui_str': 'Ammonia measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]",,0.418311,"There was no significant difference in the resolution of HE (57.1% vs 50%; P = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%). ","[{'ForeName': 'Pandey', 'Initials': 'P', 'LastName': 'Snehavardhan', 'Affiliation': 'Department of Pediatric Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Bikrant B', 'Initials': 'BB', 'LastName': 'Lal', 'Affiliation': ''}, {'ForeName': 'Vikrant', 'Initials': 'V', 'LastName': 'Sood', 'Affiliation': ''}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': ''}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Alam', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002521'] 846,31965899,Effect of cementing on pulmonary arterial pressure in vertebroplasty: A comparison of two techniques.,"BACKGROUND Increase in intraosseous pressure and displacement of bone marrow contents leading to fat embolism and hypotension during cement injection in vertebroplasty (VP). We aimed to compare the effect of low and high viscosity cements during VP on pulmonary arterial pressure (PAP) with different cannula. MATERIALS AND METHODS Fifty-two patients having multilevel VP due to osteoporotic vertebral compression fractures were randomly treated either by a high viscosity cement (group A, n = 27 patients) and 2.8 mm cannula or a low viscosity cement (group B, n = 25 patients) injected through 4.2 mm cannula. PAP was measured by standard echocardiography and blood d-dimer values were recorded preoperatively, 24 h and third day after operation. RESULTS Mean age was 69 (62-87) years in group A and 70 (64-88) years in group B, and sex and comorbidities were similar. Average number of augmented levels was 5.4 in group A and 5.7 in group B. Preoperative mean PAP was 33 mm/Hg in group A, elevated to 41 mm/Hg on first day, and decreased to 36 mm/Hg on third day. The mean PAP in group B was 35 mm/Hg preoperatively, 51 mm/Hg on first day and 46 mm/Hg on third day ( p < 0.05). The average blood d-dimer values in group A increased from 2.1 µg/mL to 2.3 µg/mL and in group B from 2.2 µg/mL to 4.2 µg/mL. CONCLUSION The finding of this study showed that high viscosity cement injected through a narrower cannula results in lesser PAP increase and d-dimer levels when compared to low viscosity cement injected through a wider cannula. Higher PAP and d-dimer level may show possible thromboembolism. This finding may give spine surgeons to reconsider their choice of cement type and cannula size.",2020,"The average blood d-dimer values in group A increased from 2.1 µg/mL to 2.3 µg/mL and in group B from 2.2 µg/mL to 4.2 µg/mL. CONCLUSION ","['Mean age was 69 (62-87) years in group A and 70 (64-88) years in group B, and sex and comorbidities were similar', 'vertebroplasty', 'Fifty-two patients having multilevel VP due to osteoporotic vertebral compression fractures']","['high viscosity cement (group A, n = 27 patients) and 2.8 mm cannula or a low viscosity cement (group B, n = 25 patients) injected through 4.2 mm cannula', 'cementing']","['average blood d-dimer values', 'PAP increase and d-dimer levels', 'pulmonary arterial pressure (PAP', 'mean PAP', 'PAP', 'pulmonary arterial pressure', 'Average number of augmented levels']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4301986', 'cui_str': 'Viscosity (property) (qualifier value)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}]","[{'cui': 'C0005768'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0303112,"The average blood d-dimer values in group A increased from 2.1 µg/mL to 2.3 µg/mL and in group B from 2.2 µg/mL to 4.2 µg/mL. CONCLUSION ","[{'ForeName': 'Alauddin', 'Initials': 'A', 'LastName': 'Kochai', 'Affiliation': 'Orthopedic and Traumatology Department, Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Meric', 'Initials': 'M', 'LastName': 'Enercan', 'Affiliation': 'Istanbul Spine Center, Florence Nightingale Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Kahraman', 'Affiliation': 'Istanbul Spine Center, Florence Nightingale Hospital, Istanbul, Turkey.'}, {'ForeName': 'Cagatay', 'Initials': 'C', 'LastName': 'Ozturk', 'Affiliation': 'Liv Hospital Ulus Orthopedic and Spine Surgery, Istanbul, Turkey.'}, {'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Hamzaoglu', 'Affiliation': 'Istanbul Spine Center, Florence Nightingale Hospital, Istanbul, Turkey.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019897659'] 847,31965906,Effects of tourniquet application on enhanced recovery after surgery (ERAS) and ischemia-reperfusion post-total knee arthroplasty: Full- versus second half-course application.,"PURPOSE Pneumatic tourniquets are used in total knee arthroplasty (TKA) for surgical field visualization and improved cementation; however, their use is controversial. This study aimed to assess the effects of tourniquet application on enhanced recovery post-TKA. METHODS A prospective randomized single-blinded trial assessed tourniquet's effects on postoperative pain, swelling, and early outcome in TKA. One-hundred and two patients with knee osteoarthritis were randomized to full-course (FC) and second half-course (SHC) application ( n = 51/group). Tumor necrosis factor-alpha (TNF-α), C-C motif chemokine ligand 2(CCL-2), pentraxin-3 (PTX-3), prostaglandin E-2 (PGE-2), superoxide dismutase-1 (SOD-1), and myoglobin (Mb) were assessed by enzyme-linked immunosorbent assay, while the visual analog scale (VAS), range of motion (ROM), and thigh circumference growth rate were recorded. RESULTS Average tourniquet duration significantly differed between the SHC (37.5 ± 5.1 min) and FC (66.4 ± 7.2 min) groups ( p < 0.01); VAS and thigh circumference growth rate in the SHC group were much lower compared with the FC group, while ROM was higher within 48 h of tourniquet removal ( p < 0.01). Blood TNF-α, PTX3, CCL2, PGE2, SOD-1, and Mb were lower in the SHC group than the FC group ( p < 0.01). Additionally, intraoperative blood loss was significantly elevated in the SHC group than the FC group ( p < 0.01), with lower postoperative blood loss in the drain ( p = 0.001). Postoperative drainage volume was reduced in the SHC group compared with the FC group ( p < 0.01); five and two patients in the FC and SHC groups required blood transfusion, respectively ( p = 0.025). Hospital stay tended to be shorter in the SHC group ( p = 0.023), and no tourniquet-related complications were recorded. CONCLUSION Improved therapeutic outcome was observed in the SHC group, indicating patients should routinely undergo TKA with SHC tourniquet application.",2020,"Blood TNF-α, PTX3, CCL2, PGE2, SOD-1, and Mb were lower in the SHC group than the FC group ( p < 0.01).","['total knee arthroplasty (TKA', 'One-hundred and two patients with knee osteoarthritis']","['full-course (FC) and second half-course (SHC) application', 'tourniquet application', 'Pneumatic tourniquets']","['Postoperative drainage volume', 'Tumor necrosis factor-alpha (TNF-α), C-C motif chemokine ligand 2(CCL-2), pentraxin-3 (PTX-3), prostaglandin E-2 (PGE-2), superoxide dismutase-1 (SOD-1), and myoglobin (Mb', 'Blood TNF-α, PTX3, CCL2, PGE2, SOD-1, and Mb', 'postoperative blood loss', 'Average tourniquet duration', 'blood transfusion', 'therapeutic outcome', 'ROM', 'intraoperative blood loss', 'postoperative pain, swelling, and early outcome in TKA', 'VAS and thigh circumference growth rate', 'Hospital stay', 'visual analog scale (VAS), range of motion (ROM), and thigh circumference growth rate']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet (procedure)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0174234', 'cui_str': 'TNF-stimulated gene 14'}, {'cui': 'C0033559', 'cui_str': 'PGE'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}, {'cui': 'C0669516', 'cui_str': 'SOD-1 Protein'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0005768'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",102.0,0.050711,"Blood TNF-α, PTX3, CCL2, PGE2, SOD-1, and Mb were lower in the SHC group than the FC group ( p < 0.01).","[{'ForeName': 'Qinggang', 'Initials': 'Q', 'LastName': 'Cao', 'Affiliation': 'Department of Orthopaedic Surgery, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Orthopaedic Surgery, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Yongfei', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopaedic Surgery, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Department of Orthopaedic Surgery, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopaedic Surgery, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedic Surgery, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Nirong', 'Initials': 'N', 'LastName': 'Bao', 'Affiliation': 'Department of Orthopaedic Surgery, Jinling Hospital, Nanjing, China.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019896026'] 848,31879945,"Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306).","PIX306 was a phase 3, randomised, single-blind, multicentre trial conducted in adult patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after ≥1 rituximab-containing regimen and were not eligible for a stem cell transplant. Patients were randomised 1:1 to pixantrone 50 mg/m 2 or gemcitabine 1000 mg/m 2 on days 1, 8 and 15 of a 28-day cycle, combined with rituximab 375 mg/m 2 on day 1, for up to six cycles. Patients were followed for up to 96 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), complete response (CR) rate, overall response rate (ORR) and safety. Overall, 312 patients were randomised (median age 73·0 years). The study did not meet its primary endpoint. Median PFS [95% confidence interval (CI)] was 7·3 months (5·2-8·4) with pixantrone + rituximab (PIX + R) and 6·3 months (4·4-8·1) with gemcitabine + rituximab [GEM + R; hazard ratio (HR): 0·85; 95% CI 0·64-1·14; P = 0·28]. Median OS was 13·3 (10·1-19·8) months with PIX + R and 19·6 (12·4-31·9) months with GEM + R (HR: 1·13; 95% CI 0·83-1·53). ORR was 61·9% and 43·9% respectively and CR rate 35·5% and 21·7%. The incidence of adverse events, including cardiac events, was not statistically significant different between PIX + R and GEM + R.",2020,"The incidence of adverse events, including cardiac events, was not statistically significant different between PIX + R and GEM + R.","['adult patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after ≥1 rituximab-containing regimen and were not eligible for a stem cell transplant', '1000', '312 patients were randomised (median age 73·0\xa0years', '1·13', 'patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation']","['gemcitabine\xa0+\xa0rituximab [GEM', 'pixantrone 50', 'GEM\xa0+\xa0R (HR', 'PIX306', 'Pixantrone plus rituximab versus gemcitabine plus rituximab', 'rituximab', 'gemcitabine']","['ORR', 'Median OS', 'incidence of adverse events, including cardiac events', 'progression-free survival (PFS', 'overall survival (OS), complete response (CR) rate, overall response rate (ORR) and safety', 'Median PFS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C1264190', 'cui_str': ""Follicular non-Hodgkin's lymphoma, large cell (disorder)""}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0445501', 'cui_str': 'Gem (qualifier value)'}, {'cui': 'C0253355', 'cui_str': 'pixantrone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",312.0,0.218353,"The incidence of adverse events, including cardiac events, was not statistically significant different between PIX + R and GEM + R.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pettengell', 'Affiliation': ""St. George's Hospital, London, UK.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Długosz-Danecka', 'Affiliation': 'Department of Haematology, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Andorsky', 'Affiliation': 'Rocky Mountain Cancer Centers, US Oncology Research, Boulder, CO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Clinical Haematology, 4th Department of Internal Medicine, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'Pencho', 'Initials': 'P', 'LastName': 'Georgiev', 'Affiliation': 'Clinic of Oncology and Haematology, University Multiprofile Hospital for Active Treatment ""Sveti Georgi"" and Medical University, Plovdiv, Bulgaria.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Quick', 'Affiliation': 'Joe Arrington Cancer Research Treatment Center, Lubbock, TX, USA.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Singer', 'Affiliation': 'CTI Biopharma, Seattle, WA, USA.'}, {'ForeName': 'Simran B', 'Initials': 'SB', 'LastName': 'Singh', 'Affiliation': 'CTI Biopharma, Seattle, WA, USA.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Pallis', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Egorov', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Haematology Department, Hospices Civils de Lyon, Université Claude Bernard Lyon-1, Pierre-Bénite, France.'}]",British journal of haematology,['10.1111/bjh.16255'] 849,31932084,Efficacy and Safety of Alirocumab in Patients With Autosomal Dominant Hypercholesterolemia Associated With Proprotein Convertase Subtilisin/Kexin Type 9 Gain-of-Function or Apolipoprotein B Loss-of-Function Mutations.,"Autosomal dominant hypercholesterolemia results from mutations affecting the low-density lipoprotein receptor pathway, including proprotein convertase subtilisin/kexin type 9 (PCSK9) gain-of-function mutations (GoFm) and apolipoprotein B (APOB) loss-of-function mutations (LoFm). This study examined the long-term efficacy and safety of alirocumab in patients with PCSK9 GoFm and APOB LoFm who participated in the open-label extension to a Phase 2 double-blind study (NCT01604824). Of the 23 patients who completed the 14-week double-blind period and 8-week follow-up, 21 opted to continue in the open-label extension (PCSK9 GoFm, n = 15; APOB LoFm, n = 6). Patients received alirocumab 150 mg every 2 weeks from week 32 up to 3 years for PCSK9 GoFm and 2 years for APOB LoFm. Mean duration of alirocumab exposure was 129 weeks (median: 144 weeks). After initiation of alirocumab treatment, low-density lipoprotein cholesterol (LDL-C) decreased in both groups. At week 80, mean percent reduction in LDL-C from baseline was 58.0% and 47.1% for PCSK9 GoFm and APOB LoFm groups, respectively. Treatment-emergent adverse events were reported in 19 patients (90.5%); no patients discontinued treatment due to treatment-emergent adverse events. In patients with autosomal dominant hypercholesterolemia and elevated LDL-C levels despite receiving maximally tolerated lipid-lowering therapies, alirocumab 150 mg every 2 weeks resulted in clinically meaningful reductions in LDL-C, sustained through to 3 years and 2 years for patients with PCSK9 GoFm and APOB LoFm, respectively. Alirocumab was generally well tolerated with no unexpected safety concerns.",2020,"At week 80, mean percent reduction in LDL-C from baseline was 58.0% and 47.1% for PCSK9 GoFm and APOB LoFm groups, respectively.","['patients with autosomal dominant hypercholesterolemia and elevated LDL-C levels', 'patients with PCSK9 GoFm and APOB LoFm who participated in the open-label extension to a Phase 2 double-blind study (NCT01604824', 'Patients With Autosomal Dominant Hypercholesterolemia Associated With Proprotein Convertase Subtilisin/Kexin Type 9', '23 patients']","['alirocumab', 'Alirocumab', 'Apolipoprotein B']","['low-density lipoprotein cholesterol (LDL-C', 'LDL-C', 'Mean duration of alirocumab exposure', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0745103', 'cui_str': 'LDL Receptor Disorder'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0458937,"At week 80, mean percent reduction in LDL-C from baseline was 58.0% and 47.1% for PCSK9 GoFm and APOB LoFm groups, respectively.","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Krempf', 'Affiliation': 'Clinique Bretéché, Nantes, France. Electronic address: michel.krempf@univ-nantes.fr.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Hopkins', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': 'Hôpital de la Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Donahue', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New Jersey.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.12.028'] 850,31926883,Long-term Results of Trimethoprim-Sulfamethoxazole Versus Placebo to Reduce the Risk of Recurrent Toxoplasma gondii Retinochoroiditis.,"PURPOSE To compare the effects of 1 year of treatment with trimethoprim-sulfamethoxazole (TMP-SMZ) vs placebo in reducing the risk of recurrence of toxoplasmic retinochoroiditis during a 6-year follow-up period. DESIGN Randomized, double-masked clinical trial. METHODS This cohort included 141 subjects recruited in Campinas, Brazil. The inclusion criterion was unilateral active recurrent toxoplasmic retinochoroiditis. All subjects were treated with 1 dose of TMP-SMZ (160 mg/800 mg) twice daily for 45 days, and all lesions healed after this treatment. After this initial treatment, subjects were randomly assigned to group 1 (1 TMP-SMZ dose every other day for 311 days) or group 2 (1 identical placebo tablet containing starch with no active ingredients every other day for 311 days). Between the second and sixth years of follow-up appointments, none of the subjects received treatment unless a new recurrence episode had occurred. The primary outcomes were recurrent toxoplasmic retinochoroiditis within the first year of follow-up and recurrent toxoplasmic retinochoroiditis in the 6 years of follow-up. RESULTS The cumulative probability of recurrence 1, 2, 3, 4, 5, and 6 years after the initial infection was, respectively, 13.0% (9/69), 17.4% (12/69), 20.3% (14/69), 23.2% (16/69), 26.1% (18/69), and 27.5% (19/69) in the placebo group and 0%, 0%, 0%, 0%, 0%, and 1.4% (1/72) in the TMP-SMZ group (P < .001; log-rank test). There were 3 cases (3/69; 4.3%) of multiple recurrences in the same individual in the placebo group. No treatment-limiting toxicity or side effects were observed in either group. New recurrences were more frequent among female subjects. CONCLUSIONS TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis and may provide long-term benefits.",2020,No treatment-limiting toxicity or side effects were observed in either group.,"['female subjects', '141 subjects recruited in Campinas, Brazil']","['trimethoprim-sulfamethoxazole (TMP-SMZ', 'placebo tablet containing starch with no active ingredients', 'trimethoprim-sulfamethoxazole', 'placebo', 'TMP-SMZ']","['cumulative probability of recurrence', 'risk of recurrent Toxoplasma gondii retinochoroiditis', 'toxicity or side effects', 'unilateral active recurrent toxoplasmic retinochoroiditis', 'risk of recurrence of toxoplasmic retinochoroiditis', 'recurrent toxoplasmic retinochoroiditis within the first year of follow up and recurrent toxoplasmic retinochoroiditis']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040557', 'cui_str': 'Toxoplasma gondii'}, {'cui': 'C0008513', 'cui_str': 'Chorioretinitis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",141.0,0.225952,No treatment-limiting toxicity or side effects were observed in either group.,"[{'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Fernandes Felix', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil. Electronic address: joaopaulofelix@hotmail.com.'}, {'ForeName': 'Rodrigo Pessoa', 'Initials': 'RP', 'LastName': 'Cavalcanti Lira', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil; Federal University of Pernambuco (UFPE), Recife, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Hermano Lucio Gomes de', 'Initials': 'HLG', 'LastName': 'Assis Filho', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Alexandre Brito', 'Initials': 'AB', 'LastName': 'Cosimo', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Mauricio Abujamra', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Leite Arieta', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.025'] 851,31568587,Dose-dependent effect of aerobic exercise on inflammatory biomarkers in a randomized controlled trial of women at high risk of breast cancer.,"BACKGROUND Increased levels of inflammation are associated with many diseases, including cancer. Physical activity can lower breast cancer risk as well as levels of inflammation. The Women In Steady Exercise Research (WISER) Sister trial was a randomized controlled trial that investigated the effects of a dosed, moderate to vigorous, aerobic exercise intervention on levels of inflammation in premenopausal women who were at high risk of developing breast cancer. METHODS Participants were randomized to control (<75 minutes per week; 41 patients), low-dose exercise (150 minutes per week; 38 patients), or high-dose exercise (300 minutes per week; 37 patients) groups. The 5-menstrual cycles-long, home-based treadmill exercise intervention gradually increased in minutes per week and intensity up to a maximum of 80% of the age-predicted maximum heart rate. Blood was collected at baseline and at follow-up and assayed for chemokine (C-C motif) ligand 2 (CCL2), interleukin 10 (IL-10), interleukin 12 (IL-12), and tumor necrosis factor α (TNF-α). RESULTS A linear dose-response relationship was observed for the proinflammatory biomarkers CCL2 (%Δ of -5.44% in the control group, -0.03% in the low-dose exercise group, and 1.54% in the high-dose exercise group), IL-12 (%Δ of -21.5% in the control group, 38.2% in the low-dose exercise group, and 25.8% in the high-dose exercise group,) and TNF-α (%Δ of -4.69% in the control group, 9.51% in the low-dose exercise group, and 15.7% in the high-dose exercise group) but not for the anti-inflammatory biomarker IL-10 (%Δ of 5.05% in the control group, 6.05% in the low-dose exercise group, and 10.6% in the high-dose exercise group). For IL-12 and TNF-α, the percentage change was significantly higher in the low-dose (IL-12: P < .001; and TNF-α: P = .01) and high-dose (IL-12: P < .001; and TNF-α: P < .001) exercise groups compared with the control group. CONCLUSIONS Moderate to vigorous aerobic exercise appeared to increase levels of proinflammatory biomarkers in a dose-dependent manner in a population of healthy women at high risk of developing breast cancer. The results of the current study suggest that for healthy premenopausal women, the mechanism of reduced breast cancer risk observed in physically active individuals may not be a result of reduced levels of inflammation.",2020,"RESULTS A linear dose-response relationship was observed for the proinflammatory biomarkers CCL2 (%Δ of -5.44% in the control group, -0.03% in the low-dose exercise group, and 1.54% in the high-dose exercise group), IL-12 (%Δ of -21.5% in the control group, 38.2% in the low-dose exercise group, and 25.8% in the high-dose exercise group,) and TNF-α (%Δ of -4.69% in the control group, 9.51% in the low-dose exercise group, and 15.7% in the high-dose exercise group) but not for the anti-inflammatory biomarker IL-10 (%Δ of 5.05% in the control group, 6.05% in the low-dose exercise group, and 10.6% in the high-dose exercise group).","['Participants were randomized to control (<75\xa0minutes per week; 41 patients', 'healthy premenopausal women', 'women at high risk of breast cancer', 'premenopausal women who were at high risk of developing breast cancer']","['TNF-α', 'home-based treadmill exercise intervention', 'aerobic exercise intervention', 'low-dose exercise', 'Steady Exercise Research (WISER', 'aerobic exercise', 'vigorous aerobic exercise']","['interleukin 10 (IL-10), interleukin 12 (IL-12), and tumor necrosis factor α (TNF-α', 'IL-12', 'proinflammatory biomarkers', 'levels of inflammation', 'proinflammatory biomarkers CCL2']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C0035168'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0532071,"RESULTS A linear dose-response relationship was observed for the proinflammatory biomarkers CCL2 (%Δ of -5.44% in the control group, -0.03% in the low-dose exercise group, and 1.54% in the high-dose exercise group), IL-12 (%Δ of -21.5% in the control group, 38.2% in the low-dose exercise group, and 25.8% in the high-dose exercise group,) and TNF-α (%Δ of -4.69% in the control group, 9.51% in the low-dose exercise group, and 15.7% in the high-dose exercise group) but not for the anti-inflammatory biomarker IL-10 (%Δ of 5.05% in the control group, 6.05% in the low-dose exercise group, and 10.6% in the high-dose exercise group).","[{'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Haley', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hibler', 'Affiliation': 'Division of Cancer Epidemiology and Prevention, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Shouhao', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sturgeon', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}]",Cancer,['10.1002/cncr.32530'] 852,30215785,Extended Nicotine Patch Treatment Among Smokers With and Without Comorbid Psychopathology.,"INTRODUCTION Individuals with psychiatric conditions smoke at higher rates than the general population and may need more intensive treatment to quit. We examined whether or not extended treatment with nicotine patch, combined with behavior counseling, would disproportionally benefit smokers with versus without a lifetime psychiatric condition. METHODS We conducted a secondary analysis of data from an effectiveness trial of treatment with 12 counseling sessions (48 weeks) and 21-mg nicotine patch (8, 24, or 52 weeks) among 525 adult daily smokers. A structured clinical interview assessed past and current psychiatric disorders (major depression, generalized anxiety disorder, alcohol abuse and/or dependence, and substance abuse and/or dependence), as described in the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition). Abstinence was bioverified at week 52. Logistic regression evaluated the effect of the psychiatric status × treatment duration interaction on abstinence at week 52, covarying for sociodemographics, baseline psychological symptoms, and treatment adherence. RESULTS At baseline, 115 (21.9%) participants were diagnosed with one or more psychiatric conditions. The psychiatric status × treatment duration interaction was significant for week 52 abstinence (p = .027). Abstinence rates between smokers with versus without a psychiatric condition in the 24-week treatment arm (9.3% vs. 31.5% abstinent) significantly differed from the 8-week treatment arm (18.8% vs. 22.3%), p = .017. Abstinence rates for smokers with (22.5%) versus without a psychiatric condition (19.7%) in the 52-week treatment arm did not differ from those in the 8-week arm. CONCLUSIONS Targeted smoking cessation treatment, rather than extending treatment duration, may be especially warranted to optimize treatment for smokers with comorbid mood, anxiety, and substance use disorders. IMPLICATIONS Individuals with psychiatric conditions smoke at higher rates and have greater difficulty quitting compared to those in the general population, but little is known about how to best optimize treatment for this high tobacco burden population. The present study found that cessation response to extended duration treatment with the transdermal nicotine patch did not differ for smokers with versus without comorbid anxiety, mood, and substance use disorders in a large-scale clinical effectiveness trial. Development of targeted behavioral treatments may be required to optimize abstinence outcomes for this high-risk population, rather than simply extending the duration of pharmacotherapy treatments.",2020,The psychiatric status by treatment duration interaction was significant for Week 52 abstinence (p=.027).,"['smokers with comorbid mood, anxiety, and substance use disorders', 'Smokers With and Without Comorbid Psychopathology', '525 adult daily smokers (Schnoll et al 2015 JAMA Intern Med']","['Nicotine Patch', '12 counseling sessions (48 weeks) and 21-mg nicotine patch', 'nicotine patch, combined with behavior counseling']",['Abstinence rates'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],525.0,0.0551061,The psychiatric status by treatment duration interaction was significant for Week 52 abstinence (p=.027).,"[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Mathew', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, Presbyterian Medical Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Wileyto', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Miele', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty191'] 853,29183752,One-Year Comparison of a Community-Based Exercise Program Versus a Day Hospital-Based Exercise Program on Quality of Life and Mental Health in Severely Burned Children.,"OBJECTIVE To compare the effects of long-term psychosocial functioning and mental health of a ""day hospital""-based exercise program (DAYEX) versus a community-based exercise program (COMBEX). DESIGN A prospective design that consisted of 2 groups (DAYEX and COMBEX). SETTING A children's hospital specialized in burn care. PARTICIPANTS Patients (N=18; DAYEX [n=9], COMBEX [n=9]) were assessed at intensive care unit discharge and up to 1 year postburn. INTERVENTIONS The Child Health Questionnaires (CHQ-Child Form [CHQ-CF87] and CHQ-Parent Form [CHQ-PF28]) were used to assess changes in quality of life from discharge to 1 year postburn. MAIN OUTCOME MEASURES CHQ-PF28 and CHQ-CF87. RESULTS Demographic characteristics and total body surface area burned were similar in both groups. Length of hospital stay was significant in the COMBEX group. CHQ-CF87 and CHQ-PF28 documented significant improvements in both groups between discharge and 1 year. Significance was evident in Physical Functioning, Bodily Pain, Self-Esteem, Change in Health, and Family Activities. CHQ-CF87 showed improvement in Family Cohesion in COMBEX more than DAYEX. CHQ-PF28 showed improvement in Role/Social Limitations-Emotional, Bodily Pain, and Family Activities in COMBEX more than DAYEX. CONCLUSIONS The proposed COMBEX program is feasible and beneficial physically, psychosocially, and mentally. The results show some improvements in the COMBEX group in optimizing function and health in severely burned children. The COMBEX group performed at least as well as the DAYEX group. Larger-scale studies are needed to validate current findings.",2020,"CHQ-PF28 showed improvement in Role/Social Limitations-Emotional, Bodily Pain, and Family Activities in COMBEX more than DAYEX. ","[""A children's hospital specialized in burn care"", 'Severely Burned Children', 'severely burned children', 'Patients (N=18; DAYEX [n=9], COMBEX [n=9]) were assessed at intensive care unit discharge and up to 1 year postburn']","['COMBEX', 'Community-Based Exercise Program', 'Day Hospital-Based Exercise Program', 'long-term psychosocial functioning and mental health of a ""day hospital""-based exercise program (DAYEX) versus a community-based exercise program (COMBEX']","['Child Health Questionnaires (CHQ-Child Form [CHQ-CF87', 'Physical Functioning, Bodily Pain, Self-Esteem, Change in Health, and Family Activities', 'Role/Social Limitations-Emotional, Bodily Pain, and Family Activities', 'CHQ-CF87 and CHQ-PF28', 'CHQ-PF28 and CHQ-CF87', 'Quality of Life and Mental Health', 'Length of hospital stay']","[{'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C1276417', 'cui_str': 'Burn care'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0530492,"CHQ-PF28 showed improvement in Role/Social Limitations-Emotional, Bodily Pain, and Family Activities in COMBEX more than DAYEX. ","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Peña', 'Affiliation': 'Department of Psychology, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX. Electronic address: rapena@utmb.edu.'}, {'ForeName': 'Oscar E', 'Initials': 'OE', 'LastName': 'Suman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Psychology, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Andersen', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Herndon', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychology, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2017.10.023'] 854,29874567,Intermittent Fasting Confers Protection in CNS Autoimmunity by Altering the Gut Microbiota.,"Multiple sclerosis (MS) is more common in western countries with diet being a potential contributing factor. Here we show that intermittent fasting (IF) ameliorated clinical course and pathology of the MS model, experimental autoimmune encephalomyelitis (EAE). IF led to increased gut bacteria richness, enrichment of the Lactobacillaceae, Bacteroidaceae, and Prevotellaceae families and enhanced antioxidative microbial metabolic pathways. IF altered T cells in the gut with a reduction of IL-17 producing T cells and an increase in regulatory T cells. Fecal microbiome transplantation from mice on IF ameliorated EAE in immunized recipient mice on a normal diet, suggesting that IF effects are at least partially mediated by the gut flora. In a pilot clinical trial in MS patients, intermittent energy restriction altered blood adipokines and the gut flora resembling protective changes observed in mice. In conclusion, IF has potent immunomodulatory effects that are at least partially mediated by the gut microbiome.",2018,IF altered T cells in the gut with a reduction of IL-17 producing T cells and an increase in regulatory T cells.,[],[],"['gut bacteria richness, enrichment of the Lactobacillaceae, Bacteroidaceae, and Prevotellaceae families and enhanced antioxidative microbial metabolic pathways', 'regulatory T\xa0cells']",[],[],"[{'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0022937', 'cui_str': 'Lactobacillaceae'}, {'cui': 'C0004660', 'cui_str': 'Bacteroidaceae'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1291081', 'cui_str': 'Metabolic Pathway'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}]",,0.0336229,IF altered T cells in the gut with a reduction of IL-17 producing T cells and an increase in regulatory T cells.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cignarella', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cantoni', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ghezzi', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA; Neurology Unit, Department of Pathophysiology and Transplantation, University of Milan, Fondazione Cà Granda, IRCCS Ospedale Policlinico, Milan, Italy.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO 63110, USA.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Dorsett', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Weinstock', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA; Department of Clinical and Experimental Sciences, Brescia University Medical School, Brescia, Italy; CEINGE Biotecnologie Avanzate, Napoli, Italy.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Cross', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA; Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Yanjiao', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA. Electronic address: yazhou@uchc.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Piccio', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA; Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis, MO, USA. Electronic address: picciol@wustl.edu.'}]",Cell metabolism,['10.1016/j.cmet.2018.05.006'] 855,31981557,Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial.,"BACKGROUND HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi. METHODS In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316. FINDINGS Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group. INTERPRETATION Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing. FUNDING United States Agency for International Development.",2020,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","['outpatients in Malawi, with a minimal risk of adverse events', 'participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi', '5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group', '1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group', 'outpatients in Malawi', 'high-burden outpatient departments in Malawi']","['facility-based HIV self-testing', 'standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling']",['proportion of outpatients tested for HIV'],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",5885.0,0.0574598,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dovel', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA; Partners in Hope, Lilongwe, Malawi. Electronic address: kdovel@mednet.ucla.edu.'}, {'ForeName': 'Frackson', 'Initials': 'F', 'LastName': 'Shaba', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'O Agatha', 'Initials': 'OA', 'LastName': 'Offorjebe', 'Affiliation': 'Department of Medicine and David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA; School of Medicine, Charles R Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Balakasi', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Phiri', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Sundeep K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': 'USAID Global Health Bureau, Washington, DC, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Brooke E', 'Initials': 'BE', 'LastName': 'Nichols', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Refiloe', 'Initials': 'R', 'LastName': 'Cele', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lungu', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Masina', 'Affiliation': 'Malawi Ministry of Health, HIV/AIDS Unit, Lilongwe, Malawi.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Coates', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30534-0'] 856,31558040,Effects of mobile health on HIV risk reduction for men who have sex with men.,"Mobile health (M-Health) has become a novel method for HIV prevention and the effects need to be promoted. The study purpose was to exam how a smartphone application (app) reduces HIV risky behaviour in men who have sex with men (MSM). The Safe Behaviour and Screening (SBS) app was developed, and included five features: record, output, and resources connection; information provision; testing services; interaction; and online statistics. A random assignment was used. The experimental group used the SBS app for six months. The control group did not use any intervention. There were 130 participants in the experimental group, and 135 in the control group. The average age of all subjects was 27.38 (SD = 5.56). Compared to the control group, the experimental group had significantly higher mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests. The frequency of anal intercourse and recreational drug usage were significantly lower in the experimental group. The SBS app could decrease the HIV risky behaviour among MSM and be applied to HIV prevention and nursing intervention.",2020,"Compared to the control group, the experimental group had significantly higher mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests.","['130 participants in the experimental group, and 135 in the control group', 'men who have sex with men (MSM', 'men who have sex with men']","['mobile health', 'smartphone application (app', 'Mobile health (M-Health']","['frequency of anal intercourse and recreational drug usage', 'HIV risky behaviour', 'mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests', 'HIV risk reduction']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0242508', 'cui_str': 'Recreational Drugs'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0919842', 'cui_str': 'Syphilis Serodiagnosis'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",130.0,0.0204205,"Compared to the control group, the experimental group had significantly higher mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests.","[{'ForeName': 'Piao-Yi', 'Initials': 'PY', 'LastName': 'Chiou', 'Affiliation': 'Department of Nursing, Medical College, National Taiwan University, Taipei City, Taiwan (R.O.C).'}, {'ForeName': 'Pei-Hung', 'Initials': 'PH', 'LastName': 'Liao', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan (R.O.C.).'}, {'ForeName': 'Chieh-Yu', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Speech language pathology and audiology, National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan (R.O.C.).'}, {'ForeName': 'Yu-Tz', 'Initials': 'YT', 'LastName': 'Hsu', 'Affiliation': 'Department of Infection, Mackay Memorial Hospital, Taipei City, Taiwan (R.O.C.).'}]",AIDS care,['10.1080/09540121.2019.1668531'] 857,31279962,"Randomized trial of oral cyclophosphamide versus oral cyclophosphamide with celecoxib for recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.","BACKGROUND Oral metronomic chemotherapy, which has low toxicity, has demonstrated promising anti-tumor and anti-angiogenic properties that may lead to prolonged progression-free survival and improved response rates in patients with recurrent epithelial ovarian cancer (EOC). These effects may be enhanced by the co-administration of anti-angiogenic agents. METHODS We conducted a randomized phase II clinical trial to evaluate the therapeutic benefit of oral metronomic cyclophosphamide (CTX) alone and with the anti-angiogenic drug celecoxib in patients with gynecological malignancies. 52 patients were randomly assigned to two treatments arms: 50 mg oral CTX daily alone (Arm A) or with 400 mg celecoxib twice daily (Arm B). The primary endpoint was response rate. Secondary endpoints included toxicity, time to treatment failure, and overall survival. RESULTS In Arm A (n = 26), 3 patients (12%) had stable disease >6 months and 1 (4%) had a partial response. In Arm B, 5 (19%) had stable disease >6 months and 1 patient (4%) had a partial response. There were no significant between-group differences in overall survival (9.69 months [95% CI 3.84-13.18] vs. 12.55 months [6.67-17.61]) or in median time to treatment failure (1.84 months [1.68-2.76] vs. 1.92 months [1.64-5.22]). The most common adverse events were nausea, vomiting, and abdominal pain. CONCLUSIONS Oral metronomic CTX has activity with no major toxicities in heavily pretreated recurrent gynecological cancers and may be considered in patients with indolent disease. We did not observe any additional benefit of celecoxib treatment, though this may be due to small sample sizes.",2019,There were no significant between-group differences in overall survival (9.69 months [95% CI 3.84-13.18] vs. 12.55 months [6.67-17.61]) or in median time to treatment failure (1.84 months [1.68-2.76] vs. 1.92 months [1.64-5.22]).,"['52 patients', 'patients with recurrent epithelial ovarian cancer (EOC', 'patients with gynecological malignancies', 'recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer', 'heavily pretreated recurrent gynecological cancers', 'patients with indolent disease']","['50\u202fmg oral CTX daily alone (Arm A) or with 400\u202fmg celecoxib', 'Oral metronomic CTX', 'celecoxib', 'oral metronomic cyclophosphamide (CTX) alone and with the anti-angiogenic drug celecoxib', 'oral cyclophosphamide', 'cyclophosphamide with celecoxib']","['median time to treatment failure', 'toxicity, time to treatment failure, and overall survival', 'partial response', 'nausea, vomiting, and abdominal pain', 'response rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0596087', 'cui_str': 'Inhibitors, Angiogenetic'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}]",52.0,0.220798,There were no significant between-group differences in overall survival (9.69 months [95% CI 3.84-13.18] vs. 12.55 months [6.67-17.61]) or in median time to treatment failure (1.84 months [1.68-2.76] vs. 1.92 months [1.64-5.22]).,"[{'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Cristea', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frankel', 'Affiliation': 'Information Sciences, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ruel', 'Affiliation': 'Information Sciences, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Clinical Informatics, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Yingyu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical Informatics, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Morgan', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Lucille', 'Initials': 'L', 'LastName': 'Leong', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Chow', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Koczywas', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Koehler', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Thehang', 'Initials': 'T', 'LastName': 'Luu', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Martel', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McNamara', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Somlo', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yen', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Amanam', 'Initials': 'A', 'LastName': 'Idorenyi', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Tinsley', 'Initials': 'T', 'LastName': 'Raechelle', 'Affiliation': 'Clinical Trial Office, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Carroll', 'Affiliation': 'Clinical Trial Office, City of Hope National Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chung', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Cancer Center, Duarte, CA, United States. Electronic address: VChung@coh.org.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2019.100155'] 858,31965432,"A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size.","Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV in rights-constrained settings need support for antiretroviral therapy (ART) adherence due to barriers including stigma. The Shikamana intervention combined modified Next Step Counseling by providers with support from trained peers to improve adherence among GBMSM living with HIV in Kenya. A randomized controlled trial with 6-month follow-up was used to determine feasibility, acceptability, safety, and initial intervention effects. Generalized estimating equations examined differences in self-reported adherence and virologic suppression. Sixty men enrolled, with 27 randomly assigned to the intervention and 33 to standard care. Retention did not differ by arm, and no adverse events occurred. Feedback on feasibility and acceptability was positive based on exit interviews. After adjustment for baseline viral suppression and confounding, the intervention group had a sixfold increased odds of viral suppression during follow-up. A larger trial of a scaled-up intervention is needed.",2020,"Retention did not differ by arm, and no adverse events occurred.","['Who Have Sex with Men in Kenya', 'Sixty men enrolled, with 27 randomly assigned to the intervention and 33 to standard care', 'Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV in rights-constrained settings', 'Gay, Bisexual, and Other Men', 'GBMSM living with HIV in Kenya']","['Shikamana intervention combined modified Next Step Counseling', 'Shikamana Intervention']","['feasibility and acceptability', 'Feasibility, Acceptability, Safety and Initial Effect Size', 'feasibility, acceptability, safety', 'viral suppression']","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",60.0,0.0909481,"Retention did not differ by arm, and no adverse events occurred.","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Graham', 'Affiliation': 'Departments of Medicine, Global Health, and Epidemiology, University of Washington, 325 Ninth Avenue, Box 359909, Seattle, WA, 98104, USA. grahamsm@uw.edu.'}, {'ForeName': 'Murugi', 'Initials': 'M', 'LastName': 'Micheni', 'Affiliation': 'Clinical Research, Kenya Medical Research Institute - Wellcome Trust Programme, Kilifi, Kenya.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Chirro', 'Affiliation': 'Clinical Research, Kenya Medical Research Institute - Wellcome Trust Programme, Kilifi, Kenya.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nzioka', 'Affiliation': 'Clinical Research, Kenya Medical Research Institute - Wellcome Trust Programme, Kilifi, Kenya.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Secor', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Mugo', 'Affiliation': 'Clinical Research, Kenya Medical Research Institute - Wellcome Trust Programme, Kilifi, Kenya.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Kombo', 'Affiliation': 'Partners for Health and Development in Africa, Nairobi, Kenya.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'van der Elst', 'Affiliation': 'Clinical Research, Kenya Medical Research Institute - Wellcome Trust Programme, Kilifi, Kenya.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Eduard J', 'Initials': 'EJ', 'LastName': 'Sanders', 'Affiliation': 'Clinical Research, Kenya Medical Research Institute - Wellcome Trust Programme, Kilifi, Kenya.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Simoni', 'Affiliation': 'Departments of Psychology; Global Health; and Gender, Women, and Sexuality Studies, University of Washington, Seattle, WA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02786-5'] 859,31965445,Therapeutic response in children with ADHD: role of observers and settings.,"BACKGROUND This study aims at characterizing the extent of correlation of treatment response (TR) obtained in various observation settings (home, school, clinic) by different observers (parents, teachers, clinicians). METHODS Children with attention deficit hyperactivity disorder (ADHD) underwent a 2-week double-blind, randomized, cross-over clinical trial with methylphenidate and placebo, and various measures were obtained during the 2 weeks. Interrelationships of TR were examined using Pearson's correlation coefficients. RESULTS The study included 526 children (420 male, 106 female) with ADHD. TR between different observers shows a variable correlation between parents and teachers. No correlation is seen between parents/teacher evaluation of TR and laboratory-based measures (Continuous Performance Task; Restricted Academic Situation Scale). CONCLUSION The results firmly support the need to synthesize information from many sources in evaluating TR in ADHD.",2020,"No correlation is seen between parents/teacher evaluation of TR and laboratory-based measures (Continuous Performance Task; Restricted Academic Situation Scale). ","['children with ADHD', '526 children (420 male, 106 female) with ADHD', 'Children with attention deficit hyperactivity disorder (ADHD']",['methylphenidate and placebo'],['Therapeutic response'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}]",526.0,0.0933233,"No correlation is seen between parents/teacher evaluation of TR and laboratory-based measures (Continuous Performance Task; Restricted Academic Situation Scale). ","[{'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada. ridha.joober@mcgill.ca.'}]",World journal of pediatrics : WJP,['10.1007/s12519-019-00332-5'] 860,31960133,Prospective multicenter study of reduced port surgery combined with transvaginal specimen extraction for colorectal cancer resection.,"PURPOSE The relevance of transvaginal specimen extraction (TVSE) combined with reduced port surgery (RPS) remains unknown. This study investigated the feasibility of TVSE with RPS according to short-term outcomes and cosmesis. METHODS This prospective multicenter study enrolled ten patients at three institutions. For the semi-quantification of each parameter, we administered questionnaires to assess pain (visual analogue scale), subjective/objective wound healing esthetics [photo series questionnaires (PSQ)], and quality of life (QOL). RESULTS No operative complications occurred, except one case of urinary tract infection, which was promptly cured with antibiotics. On day 0, pain was rated at 2.3 ± 0.67 at rest and 4.9 ± 0.82 during sneezing; these ratings gradually declined over time. The PSQ showed that the patient ratings of wound esthetics after TVSE were not inferior to ratings from patients after conventional laparoscopy or single incision laparoscopic surgery, and they were significantly higher than the patient ratings of wounds after laparotomy (P < 0.05). The QOL scores showed that, in comparison to before surgery, after surgery, patients reported significant deterioration of their physical function (96.67 ± 1.49 vs. 87.33 ± 2.71), emotional function (93.33 ± 2.72 vs. 86.67 ± 2.22), fatigue (7.78 ± 3.72 vs. 26.67 ± 8.31), and pain (6.67 ± 3.69 vs. 18.33 ± 4.61). CONCLUSION TVSE with RPS for colorectal cancer was feasible and was associated with a low degree of postoperative pain.",2020,"The QOL scores showed that, in comparison to before surgery, after surgery, patients reported significant deterioration of their physical function (96.67 ± 1.49 vs. 87.33 ± 2.71), emotional function (93.33 ± 2.72 vs. 86.67 ± 2.22), fatigue (7.78 ± 3.72 vs. 26.67 ± 8.31), and pain (6.67 ± 3.69 vs. 18.33 ± 4.61). ","['colorectal cancer resection', 'enrolled ten patients at three institutions']","['TVSE with RPS', 'transvaginal specimen extraction (TVSE) combined with reduced port surgery (RPS', 'reduced port surgery combined with transvaginal specimen extraction']","['emotional function', 'patient ratings of wound esthetics', 'pain (visual analogue scale), subjective/objective wound healing esthetics [photo series questionnaires (PSQ)], and quality of life (QOL', 'operative complications', 'QOL scores', 'deterioration of their physical function', 'fatigue', 'pain', 'urinary tract infection']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",10.0,0.0322945,"The QOL scores showed that, in comparison to before surgery, after surgery, patients reported significant deterioration of their physical function (96.67 ± 1.49 vs. 87.33 ± 2.71), emotional function (93.33 ± 2.72 vs. 86.67 ± 2.22), fatigue (7.78 ± 3.72 vs. 26.67 ± 8.31), and pain (6.67 ± 3.69 vs. 18.33 ± 4.61). ","[{'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hamabe', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Colorectal and Pelvic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 227-8577, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Department of Surgery, Institute of Gastroenterology, Nagaoka Chuo General Hospital, 2041 Kawasaki-cho, Nagaoka, Niigata, 940-8653, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Itoh', 'Affiliation': 'Department of Colorectal and Pelvic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 227-8577, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Takemasa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan. itakemasa@sapmed.ac.jp.'}]",Surgery today,['10.1007/s00595-019-01946-y'] 861,31960275,Clinical and Metabolic Responses to Magnesium Supplementation in Women with Polycystic Ovary Syndrome.,"We hypothesized that magnesium supplementation might help improve metabolic profiles and clinical symptoms of polycystic ovary syndrome (PCOS) through its role in insulin action. The present study aimed to investigate the effect of magnesium supplementation on metabolic profiles and levels of sex hormones in women with PCOS. In this parallel randomized, double-blind, placebo-controlled clinical trial, 60 women with PCOS aged 20-45 years were recruited. After stratification for body mass index (BMI), age, and types of medications, participants were randomly assigned to consume magnesium supplements (containing 250 mg magnesium oxide) or placebo for 8 weeks. To assess biochemical indicators, a venous blood sample was taken after an overnight fasting. The mean age of study participants was 26.4 years. We found that magnesium supplementation for 8 weeks among women with PCOS had favorable effects on BMI compared with the placebo group (changes from baseline in intervention group: - 0.31 ± 0.07 vs. 0.07 ± 0.09 kg/m 2 in control group). In addition, the supplementation lead to preventing the increase in waist circumference in intervention group compared with the control group (0.02 vs. 1.15 cm). No significant effects on glycemic variables and lipid profile were seen following the magnesium supplementation. A significant increase in serum LH levels in intervention group and a decrease in placebo group were observed (P = 0.01). Although we found a significant decrease in serum testosterone levels in intervention and placebo groups, comparing the changes between the two groups, a marginally significant difference in serum testosterone levels was found (51.65 vs. 47.80 in intervention, 43.41 vs. 39.46 in placebo, P = 0.08). A significant increase in serum dehydroepiandrogens (DHEA) (136.32 vs. 172.37 intervention, 102.74 vs. 120.15 placebo, P = 0.01) was seen in two groups. Magnesium supplementation had no significant effects on FSH, 17OH-progesteron, sex hormone-binding globulin (SHBG), and free androgen index (FAI) levels. We found evidence indicating that magnesium supplementation did not influence serum lipid profiles and glycemic indicators among women with PCOS. Magnesium supplementation resulted in reduced BMI and testosterone levels as well as increased DHEA concentrations in women with PCOS. Also, magnesium supplementation may increase serum LH levels. ClinicalTrials.gov IRCT registration no. NCT02178150.",2020,"Magnesium supplementation had no significant effects on FSH, 17OH-progesteron, sex hormone-binding globulin (SHBG), and free androgen index (FAI) levels.","['women with PCOS', 'The mean age of study participants was 26.4\xa0years', '60 women with PCOS aged 20-45\xa0years were recruited', 'Women with Polycystic Ovary Syndrome']","['Magnesium Supplementation', 'Magnesium supplementation', 'placebo', 'consume magnesium supplements (containing 250\xa0mg magnesium oxide) or placebo', 'magnesium supplementation']","['serum dehydroepiandrogens (DHEA', 'BMI and testosterone levels', 'glycemic variables and lipid profile', 'BMI', 'serum testosterone levels', 'serum lipid profiles and glycemic indicators', 'waist circumference', 'FSH, 17OH-progesteron, sex hormone-binding globulin (SHBG), and free androgen index (FAI) levels', 'metabolic profiles and levels of sex hormones', 'DHEA concentrations', 'serum LH levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1268858', 'cui_str': 'Magnesium supplement'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1304771', 'cui_str': 'Serum LH measurement'}]",60.0,0.715522,"Magnesium supplementation had no significant effects on FSH, 17OH-progesteron, sex hormone-binding globulin (SHBG), and free androgen index (FAI) levels.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farsinejad-Marj', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Azadbakht', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Mardanian', 'Affiliation': 'Department of Obstetrics and Gynecology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parvane', 'Initials': 'P', 'LastName': 'Saneei', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. a-esmaillzadeh@sina.tums.ac.ir.'}]",Biological trace element research,['10.1007/s12011-019-01923-z'] 862,31736328,Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to Age: Insights From DAPA-HF.,"BACKGROUND The DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure) showed that dapagliflozin added to other guideline-recommended therapies reduced the risk of mortality and heart failure hospitalization and improved symptoms in patients with heart failure and reduced ejection fraction. We examined the effects of dapagliflozin according to age, given potential concerns about the efficacy and safety of therapies in the elderly. METHODS Patients in New York Heart Association functional class II or greater with a left ventricular ejection fraction ≤40% and a modest elevation of NT-proBNP (N-terminal pro-B-type natriuretic peptide) were eligible. Key exclusion criteria included systolic blood pressure <95 mm Hg and estimated glomerular filtration rate <30 mL·min -1 ·1.73 m -2 . The primary outcome was the composite of an episode of worsening heart failure (heart failure hospitalization or urgent heart failure visit) or cardiovascular death, whichever occurred first. RESULTS A total of 4744 patients 22 to 94 years of age (mean age, 66.3 [SD 10.9] years) were randomized: 636 patients (13.4%) were <55 years of age, 1242 (26.2%) were 55 to 64 years of age, 1717 (36.2%) were 65 to 74 years of age, and 1149 (24.2%) were ≥75 years of age. The rate of the primary outcome (per 100 person-years, placebo arm) in each age group was 13.6 (95% CI, 10.4-17.9), 15.7 (95% CI, 13.2-18.7), 15.1 (95% CI, 13.1-17.5), and 18.0 (95% CI, 15.2-21.4) with corresponding dapagliflozin/placebo hazard ratios of 0.87 (95% CI, 0.60-1.28), 0.71 (95% CI, 0.55-0.93), 0.76 (95% CI, 0.61-0.95), and 0.68 (95% CI, 0.53-0.88; P for interaction=0.76). Consistent benefits were observed for the components of the primary outcome, all-cause mortality, and symptoms. Although adverse events and study drug discontinuation increased with age, neither was significantly more common with dapagliflozin in any age group. CONCLUSIONS Dapagliflozin reduced the risk of death and worsening heart failure and improved symptoms across the broad spectrum of age studied in DAPA-HF. There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT03036124.",2020,"There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals. ","['Heart Failure', '95 mm Hg and estimated glomerular filtration rate <30 mL·min -1 ·1.73 m -2 ', '4744 patients 22 to 94 years of age (mean age, 66.3 [SD 10.9] years) were randomized: 636 patients (13.4%) were <55 years of age, 1242 (26.2%) were 55 to 64 years of age, 1717 (36.2%) were 65 to 74 years of age, and 1149 (24.2%) were ≥75 years of age', 'Patients in New York Heart Association functional class II or greater with a left ventricular ejection fraction ≤40% and a modest elevation of NT-proBNP (N-terminal pro-B-type natriuretic peptide) were eligible', 'patients with heart failure and reduced ejection fraction']","['placebo', 'Dapagliflozin', 'dapagliflozin']","['systolic blood pressure', 'tolerability or safety events', 'Efficacy and Safety', 'risk of death and worsening heart failure', 'composite of an episode of worsening heart failure (heart failure hospitalization or urgent heart failure visit) or cardiovascular death, whichever occurred first', 'Ejection Fraction']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3811844'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",636.0,0.305807,"There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals. ","[{'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Argentina (F.M.).'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Serenelli', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil (J.C.N.).'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taiwan (C.E.-C.).'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology of Russia, Moscow (S.T.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine (S.D.S.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (M.N.K.).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland (P.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group (M.S.S.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Dutkiewicz-Piasecka', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Warsaw, Poland (M.D.-P.).'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., M. Söjstrand, A.M.L.).'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., M. Söjstrand, A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., M. Söjstrand, A.M.L.).'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044133'] 863,31860203,[Efficiency estimation of diet therapy with protein component modification in patients with obesity and purine metabolism disorder].,"The development of a personalized nutritional approach to diet therapy for patients with obesity and hyperuricemia, aimed at increasing the treatment effectiveness of these patients, is an urgent task. The aim : to assess the impact of nutritional approach with a modification of the protein component on body composition and biochemical parameters in patients with obesity and purine metabolism disorder. Material and methods . A randomized controlled trial was conducted, and included 50 patients (average age 46.9±2.5 years) with obesity and purine metabolism disorder. All patients were divided into two groups of 25 people. Within 2 weeks patients of group 1 received the main version of a standard low-calorie diet (1730 kcal, protein - 87.4 g, fat - 61.4 g, carbohydrates - 207 g). Group 2 received a personalized version of the diet (2125 kcal, protein - 100.2 g, fat - 75.9 g, carbohydrate - 260 g) with the modification of the protein component: protein content of at least 90 g per day, restriction of animal products containing a high purine load. Results and discussion . During diet therapy the decrease in fat mass in group 1 patients averaged 4.4%, visceral fat area - 8.6% (p<0.05) and in patients of group 2 - 6.9 and 9.1% respectively (p<0.05). During treatment a significant decrease in muscle mass was observed in group 1 at average 3.9% (p<0.05), and in group 2 on the basis of personal nutritional approach there was a slight decrease in muscle mass at average of 1.5%. After treatment patients of the two groups showed improvement in a number of indicators of lipid and carbohydrate metabolism: a significant decrease (p<0.05) of glucose, total cholesterol, LDL cholesterol and triglycerides in blood serum by 18.2-19.1, 23.2-23.6, 24.2-25.0 и 28.5-30.4%. However, patients in group 1 showed a slight decrease in uric acid in blood serum at average 7.6%, and patients in group 2 who received a personal nutritional approach with a modification of the protein component showed a significant decrease in uric acid at average of 12.5% (p<0.05). Conclusion . The obtained data indicate the need for a personal nutritional approach with a modification of the protein component in patients with obesity and purine metabolism disorder, which will prevent the development and progression of complications associated with obesity.",2019,"During treatment a significant decrease in muscle mass was observed in group 1 at average 3.9% (p<0.05), and in group 2 on the basis of personal nutritional approach there was a slight decrease in muscle mass at average of 1.5%.","['patients with obesity and hyperuricemia', '50 patients (average age 46.9±2.5 years) with obesity and purine metabolism disorder', 'patients with obesity and purine metabolism disorder']","['diet therapy with protein component modification', 'personalized nutritional approach to diet therapy', 'personalized version of the diet (2125 kcal, protein - 100.2 g, fat - 75.9 g, carbohydrate - 260 g) with the modification of the protein component: protein content of at least 90 g per day, restriction of animal products containing a high purine load', 'standard low-calorie diet', 'protein component']","['uric acid in blood serum', 'fat mass', 'number of indicators of lipid and carbohydrate metabolism', 'uric acid', 'muscle mass', 'glucose, total cholesterol, LDL cholesterol and triglycerides in blood serum']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0268104', 'cui_str': 'Disorder of purine metabolism'}]","[{'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0868922', 'cui_str': 'Animal product'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220903', 'cui_str': 'purine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0302820', 'cui_str': 'Carbohydrate Metabolism'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",50.0,0.0165693,"During treatment a significant decrease in muscle mass was observed in group 1 at average 3.9% (p<0.05), and in group 2 on the basis of personal nutritional approach there was a slight decrease in muscle mass at average of 1.5%.","[{'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Lapik', 'Affiliation': 'Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Gapparova', 'Affiliation': 'Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia.'}, {'ForeName': 'Yu G', 'Initials': 'YG', 'LastName': 'Chehonina', 'Affiliation': 'Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia.'}]",Voprosy pitaniia,['10.24411/0042-8833-2019-10068'] 864,31950307,The Influence of Relationship Dynamics and Sexual Agreements on Perceived Partner Support and Benefit of PrEP Use Among Same-Sex Male Couples in the U.S.,"Use of Pre-exposure prophylaxis (PrEP) for HIV prevention by men who have sex with men (MSM) may be impacted by relationship dynamics. We assessed perceived partner support of PrEP use and benefit of PrEP by relationship characteristics among male couples. Baseline data from a randomized control trial of video-based HIV counseling and testing among male couples in the U.S. were used in adjusted multilevel regression models to assess individual and dyadic characteristics. Among 659 participants, 73.3% thought their partner would be supportive of their PrEP use; 26.7% reported their partner would not support PrEP use, which was significantly associated with intimate partner violence (IPV) (p = 0.008). Most (57.7%) did not believe PrEP would be beneficial to them or their partner. Couples with a sexual agreement allowing outside partners were significantly associated with higher perceived support of partners for PrEP (p < 0.001) and benefit of PrEP use (p < 0.001). Perceived partner support of PrEP was high but perceived benefit of PrEP was low, both shaped by relationship dynamics that highlight the need for tailored dyadic interventions. The association between perceived PrEP support and IPV points to the need to integrate relationship contexts in HIV prevention programs.",2020,Couples with a sexual agreement allowing outside partners were significantly associated with higher perceived support of partners for PrEP (p < 0.001) and benefit of PrEP use (p < 0.001).,"['male couples in the U.S', 'male couples', 'Same-Sex Male Couples in the U.S', 'men who have sex with men (MSM']","['video-based HIV counseling', 'Pre-exposure prophylaxis (PrEP', 'PrEP']",['intimate partner violence (IPV'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]",659.0,0.0471386,Couples with a sexual agreement allowing outside partners were significantly associated with higher perceived support of partners for PrEP (p < 0.001) and benefit of PrEP use (p < 0.001).,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Kahle', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA. ekahle@umich.edu.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02782-9'] 865,30170781,"Effects of a 6-month multi-strain probiotics supplementation in endotoxemic, inflammatory and cardiometabolic status of T2DM patients: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE The aim of this trial was to characterize the beneficial effects of probiotics on decreasing endotoxin levels and other cardiometabolic parameters in Arab patients with type 2 diabetes mellitus (T2DM). METHODS Saudi adults with naïve T2DM (n = 30; 12 males and 18 females) were randomly allocated to receive twice daily placebo or 2.5 × 10 9  cfu/g of Ecologic ® Barrier (multi-strain probiotics; n = 31; 14 males and 17 females) in a double-blind manner over a 6 month period, respectively. Anthropometrics were measured and fasting blood samples were collected to analyze endotoxin, glycemic parameters [glucose, insulin, c-peptide and homeostasis model assessment for insulin resistance (HOMA-IR)], lipids [triglycerides, total cholesterol, low and high-density lipoprotein (LDL and HDL, respectively) cholesterol and total/HDL-cholesterol ratio], inflammatory markers [tumor-necrosis factor-alpha (TNF-α), interleukin-6 (IL-6) and C-reactive protein (CRP)] and adipocytokines [leptin, adiponectin and resistin] at baseline and after 3 and 6 months of intervention. RESULTS Multi-strain probiotics supplementation for 6 months caused a significant decrease in circulating levels of endotoxin by almost 70% over 6 months, as well as glucose (38%), insulin (38%), HOMA-IR (64%), triglycerides (48%), total cholesterol (19%), total/HDL-cholesterol ratio (19%), TNF-α (67%), IL-6 (77%), CRP (53%), resistin (53%), and a significant increase in adiponectin (72%) as compared with baseline. Only HOMA-IR had a clinically significant reduction (-3.4, 64.2%) in the probiotics group as compared to placebo group at all time points. No other clinically significant changes were observed between the probiotic or placebo group at 3 and 6 months in other markers. CONCLUSION Multi-strain probiotic supplementation over 6 months as a monotherapy significantly decreased HOMA-IR in T2DM patients, with the probiotic treatment group highlighting reduced inflammation and improved cardiometabolic profile. As such, multi-strain probiotics is a promising adjuvant anti-diabetes therapy. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01765517.",2019,"Only HOMA-IR had a clinically significant reduction (-3.4, 64.2%) in the probiotics group as compared to placebo group at all time points.","['T2DM patients', 'n\xa0=\xa030; 12 males and 18 females', 'Saudi adults with naïve T2DM', 'Arab patients with type 2 diabetes mellitus (T2DM', 'n = 31; 14 males and 17 females']","['placebo or 2.5\xa0×\xa010 9 \xa0cfu/g of Ecologic ® Barrier (multi-strain probiotics', 'placebo', 'Multi-strain probiotic supplementation', 'probiotics', '6-month multi-strain probiotics supplementation']","['triglycerides', 'endotoxemic, inflammatory and cardiometabolic status', 'circulating levels of endotoxin', 'total cholesterol', 'total/HDL-cholesterol ratio', 'TNF-α', 'endotoxin, glycemic parameters [glucose, insulin, c-peptide and homeostasis model assessment for insulin resistance (HOMA-IR)], lipids [triglycerides, total cholesterol, low and high-density lipoprotein (LDL and HDL, respectively) cholesterol and total/HDL-cholesterol ratio], inflammatory markers [tumor-necrosis factor-alpha (TNF-α), interleukin-6 (IL-6) and C-reactive protein (CRP)] and adipocytokines [leptin, adiponectin and resistin', 'IL-6', 'CRP', 'adiponectin', 'endotoxin levels', 'inflammation and improved cardiometabolic profile', 'HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439362', 'cui_str': 'cfu/g'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.239221,"Only HOMA-IR had a clinically significant reduction (-3.4, 64.2%) in the probiotics group as compared to placebo group at all time points.","[{'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Sabico', 'Affiliation': 'Warwick Medical School, Division of Biomedical Sciences, University of Warwick, UHCW Trust, Clifford Bridge Road, Walsgrave, Coventry, CV2 2DX, UK; Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. Electronic address: s.l.sabico@warwick.ac.uk.'}, {'ForeName': 'Ayah', 'Initials': 'A', 'LastName': 'Al-Mashharawi', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Daghri', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Kaiser', 'Initials': 'K', 'LastName': 'Wani', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Osama E', 'Initials': 'OE', 'LastName': 'Amer', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Danish S', 'Initials': 'DS', 'LastName': 'Hussain', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Mohammed Ghouse', 'Initials': 'MG', 'LastName': 'Ahmed Ansari', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Masoud', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Majed S', 'Initials': 'MS', 'LastName': 'Alokail', 'Affiliation': 'Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'McTernan', 'Affiliation': 'School of Science and Technology, Department of Biosciences, Nottingham Trent University, Nottingham, NG1 8NS, UK. Electronic address: philip.mcTernan@ntu.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.08.009'] 866,30097364,Preoperative administration of Omega-3 fatty acids on postoperative pain and acute-phase reactants in patients undergoing Roux-en-Y gastric bypass: A randomized clinical trial.,"BACKGROUND The term ""Immunonutrition"" (IMN) describes the enteral administration of certain substrates with a theoretical immunomodulating function. From all the elements conforming these IMN formulas, Omega-3 fatty acids (O3FA) are hypothesized to be the most important component for immunomodulation, with increased anti-inflammatory and antioxidant effect. PATIENTS AND METHODS A prospective randomized clinical trial of all the patients undergoing laparoscopic Roux-en-Y gastric bypass was performed. Patients were randomly assigned into 2 groups: those patients receiving a preoperative balanced energy high-protein formula (Control Group) and those ones who received the same preoperative nutritional formula enriched with O3FA (Experimental Group). In both groups, there was a restriction to 900 Kcal/day. Nutritional intervention started 10 days before surgery and was maintained up to 8 h before the surgical act. Preoperative weight loss, postoperative pain, complications and acute phase reactants were investigated. RESULTS 40 patients were included in the study, 20 in each group. Preoperative excess weight loss (EWL) with the prescribed treatment was 10.6 ± 7.7% in Control Group and 14.1 ± 5.8% in the Experimental Group (p = 0.024). Mean postoperative pain was 25 ± 9.2 mm in Control group and 10,9 ± 4,4 mm in Experimental Group (p = 0.015). CRP determined 24 h after surgery was significantly lower in the Experimental Group than in the Control Group. There were not significant differences in complications, mortality or readmission rates between groups. CONCLUSIONS The use of a nutritional supplement enriched with O3FA is associated with a greater preoperative weight loss, reduced postoperative pain and decreased postoperative levels of C reactive protein.",2019,"There were not significant differences in complications, mortality or readmission rates between groups. ","['patients undergoing Roux-en-Y gastric bypass', '40 patients were included in the study, 20 in each group', 'patients undergoing']","['preoperative balanced energy high-protein formula (Control Group) and those ones who received the same preoperative nutritional formula enriched with O3FA (Experimental Group', 'laparoscopic Roux-en-Y gastric bypass', 'Omega-3 fatty acids']","['complications, mortality or readmission rates', 'Preoperative excess weight loss (EWL', 'postoperative pain and acute-phase reactants', 'Mean postoperative pain', 'Preoperative weight loss, postoperative pain, complications and acute phase reactants', 'preoperative weight loss, reduced postoperative pain', 'CRP determined 24\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C3853288', 'cui_str': 'High protein formula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4521952', 'cui_str': 'Acute phase reactant'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",40.0,0.0290055,"There were not significant differences in complications, mortality or readmission rates between groups. ","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Department of Surgery, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain. Electronic address: jruiztovar@gmail.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Blanca', 'Affiliation': 'Department of Endocrinology, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Department of Surgery, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Surgery, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Endocrinology, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Paniagua', 'Affiliation': 'Department of Endocrinology, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Prieto', 'Affiliation': 'Department of Endocrinology, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Ramallo', 'Affiliation': 'Department of Endocrinology, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Llanos', 'Affiliation': 'Clinical Research Unit, Instituto de Investigación Sanitaria-Fundacion Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'Department of Surgery, Bariatric Surgery Unit, University Hospital Rey Juan Carlos, Madrid, Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.07.026'] 867,31356986,Effect of remote ischemic preconditioning on electrophysiological parameters in nonvalvular paroxysmal atrial fibrillation: The RIPPAF Randomized Clinical Trial.,"BACKGROUND Atrial fibrillation (AF) remains the most relevant arrhythmia with a prevalence of 2%. The treatment options are either highly invasive and cost-intensive or limited by potential side effects or insufficient efficacy. However, no direct means of prevention that could reduce the burden of AF have been tested. OBJECTIVE The purpose of this study was to determine whether remote ischemic preconditioning (RIPC) has an impact on inducibility and sustainability of AF. METHODS A total of 146 patients with paroxysmal AF undergoing electrophysiology study were randomized to receive either RIPC, performed by short episodes of forearm ischemia, or sham intervention (clinicaltrials.gov identifier: NCT02779660). Effective refractory periods, conduction times, velocities, and conduction delays measured were analyzed by pacing from the coronary sinus (CS). End points of the study were the inducibility and sustainability of AF after prespecified rapid pacing sequences. RESULTS RIPC significantly reduces the inducibility (odds ratio 0.35; 95% confidence interval 0.17-0.71; P = .003) and sustainability (odds ratio 0.36; 95% confidence interval 0.16-0.81; P = .01) of AF. Furthermore, it decreased dispersion of atrial refractory periods (16.0 ± 14.0 ms vs 22.7 ± 19.0 ms; P = .021) as well as atrial conduction delays (49.2 ± 19.6 ms vs 56.2 ± 22.5 ms; P = .049 for proximal CS and 42.4 ± 16.6 ms vs 49.8 ± 22.2 ms; P = .029 for distal CS). In the whole cohort, longer atrial conduction delay (57.6 ± 22.2 ms vs 50.0 ± 20.5 ms; P = .044) and slower conduction velocity (1.74 ± 0.3 mm/ms vs 1.93 ± 0.5 mm/ms; P = .006) were associated with inducibility of AF whereas a wider dispersion of effective refractory periods (25.9 ± 18.3 ms vs 15.7 ± 11.6 ms; P = .028) maintained AF episodes. CONCLUSION RIPC reduces the inducibility and sustainability of AF, which is possibly mediated by changes in electrophysiological properties of the atria. It may be used as a simple noninvasive procedure to reduce AF burden.",2020,"RESULTS RIPC significantly reduces the inducibility (odds ratio 0.35; 95% confidence interval 0.17-0.71; P = .003) and sustainability (odds ratio 0.36; 95% confidence interval 0.16-0.81; P = .01) of AF.","['A total of 146 patients with paroxysmal AF undergoing electrophysiology study', 'nonvalvular paroxysmal atrial fibrillation']","['remote ischemic preconditioning (RIPC', 'RIPC, performed by short episodes of forearm ischemia, or sham intervention (clinicaltrials.gov identifier', 'remote ischemic preconditioning']","['inducibility of AF', 'Effective refractory periods, conduction times, velocities, and conduction delays', 'inducibility', 'longer atrial conduction delay', 'slower conduction velocity', 'dispersion of atrial refractory periods', 'atrial conduction delays', 'inducibility and sustainability of AF', 'electrophysiological parameters']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}]","[{'cui': 'C0428937', 'cui_str': 'Effective refractory period (cardiac conduction)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",146.0,0.137714,"RESULTS RIPC significantly reduces the inducibility (odds ratio 0.35; 95% confidence interval 0.17-0.71; P = .003) and sustainability (odds ratio 0.36; 95% confidence interval 0.16-0.81; P = .01) of AF.","[{'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Kosiuk', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany. Electronic address: jedrzejkosiuk@hotmail.com.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Langenhan', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Stegmann', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Uhe', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany; Department IV Cardiology, Division of Internal Medicine, Neurology and Dermatology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Dagres', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Dinov', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kircher', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Sommer', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany; Department of Electrophysiology, Heart and Diabetes Center NRW, University Hospital of the Ruhr University of Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Bertagnolli', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bollmann', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.'}]",Heart rhythm,['10.1016/j.hrthm.2019.07.026'] 868,31479563,Statin use and longitudinal changes in prostate volume; results from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial.,"OBJECTIVE To test the association between statin use and prostate volume (PV) change over time using data from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial, a 4-year randomised controlled trial testing dutasteride for prostate cancer chemoprevention. SUBJECTS/PATIENTS AND METHODS We identified men with a baseline negative prostate biopsy from REDUCE who did not undergo prostate surgery or develop prostate cancer over the trial period. Men reported statin use at baseline. PV was determined from transrectal ultrasonography performed to guide prostate biopsy at baseline, and 2- and 4-years after randomisation. Multivariable generalised estimating equations tested differences in PV change over time by statin use, overall and stratified by treatment arm. We tested for interactions between statins and time in association with PV using the Wald test. RESULTS Of 4106 men, 17% used statins at baseline. Baseline PV did not differ by statin use. Relative to non-users, statin users had decreasing PVs over the trial period (P = 0.027). Similar patterns were seen in the dutasteride and placebo arms, although neither reached statistical significance. The mean estimated PV was modestly but significantly lower in statin users relative to non-users in the dutasteride arm at 2-years (4.5%, P = 0.032) and 4-years (4.0%, P = 0.033), with similar (3-3.3%) but non-significant effects in the placebo arm. CONCLUSION If confirmed, our present findings support a role for statins in modestly attenuating PV growth, with a magnitude of effect in line with previously reported prostate-specific antigen-lowering effects of statins (~4%). Future studies are needed to assess whether this putative role for statins in PV growth could impact lower urinary tract symptom development or progression.",2020,"Mean estimated PV was modestly but significantly lower in statin users relative to non-users in the dutasteride arm at 2-years (4.5%, p=0.032) and 4-years (4.0%, p=0.033), with similar (3-3.3%) but non-significant effects in the placebo arm. ","['men with a baseline negative prostate biopsy from REDUCE who did not undergo prostate surgery or develop prostate cancer over the trial period', 'Of 4,106 men, 17% used statins at baseline']","['dutasteride', 'dutasteride and placebo']","['Baseline PV', 'Mean estimated PV']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",4106.0,0.2211,"Mean estimated PV was modestly but significantly lower in statin users relative to non-users in the dutasteride arm at 2-years (4.5%, p=0.032) and 4-years (4.0%, p=0.033), with similar (3-3.3%) but non-significant effects in the placebo arm. ","[{'ForeName': 'Emma H', 'Initials': 'EH', 'LastName': 'Allott', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Csizmadi', 'Affiliation': 'Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Howard', 'Affiliation': 'Duke Cancer Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Roberto L', 'Initials': 'RL', 'LastName': 'Muller', 'Affiliation': 'Division of Urology, Center of Oncologic Research (CEPON), Florianopolis, Santa Catarina, Brazil.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Moreira', 'Affiliation': 'Department of Urology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Claus G', 'Initials': 'CG', 'LastName': 'Roehrborn', 'Affiliation': 'Department of Urology, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",BJU international,['10.1111/bju.14905'] 869,31961490,"The Incredible Years Autism Spectrum and Language Delays Parent Program: A Pragmatic, Feasibility Randomized Controlled Trial.","Behavior problems in children with autism spectrum disorders (ASD) are common and particularly stressful for parents. This study aimed to examine the feasibility of delivering a parenting program in existing services, and the feasibility of conducting a future large-scale Randomized Controlled Trial evaluation of the effectiveness of the intervention. Parents of children aged 3-8 years with a diagnosis of ASD, or strongly suspected ASD were eligible to participate. A multicenter, pragmatic, feasibility randomized controlled trial was conducted in four specialist children's services in Wales. Families were randomly assigned to receive the Incredible Years® Autism Spectrum and Language Delays (IY-ASLD) parent program immediately or to a wait-list, treatment as usual control condition. IY-ASLD sessions were delivered once a week for 12 weeks. The primary outcomes related to feasibility (recruitment, retention, fidelity, and acceptability). Preliminary outcome analyses were conducted using covariance models controlling for study site and baseline scores. From October 5 to December 19, 2016, 58 families were randomized, 29 to IY-ASLD and 29 to control. Three parents did not attend any sessions while 19 (73%) completed the program. Fidelity of delivery was high (88%), as was satisfaction with the program. Fifty-three (91%) completed the follow-up measures. All 95% CIs for effect sizes included zero in exploratory outcome analyses. This study supports the feasibility of delivering the IY-ASLD in existing services with good levels of acceptability and fidelity evident. A larger randomized controlled trial is required to examine the effectiveness of the program. Autism Res 2020, 13: 1011-1022. © 2020 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: This study examined the feasibility and acceptability of delivering a parenting program for parents of children aged 3-8 years with Autism Spectrum Disorder in existing child services. Recruitment and retention in the study were good and parents rated all aspects of the program positively. Practitioners were able to deliver the program as intended and the measures used for program outcomes were appropriate. A larger study to examine program effectiveness would be feasible.",2020,This study examined the feasibility and acceptability of delivering a parenting program for parents of children aged 3-8 years with Autism Spectrum Disorder in existing child services.,"['parents of children aged 3-8\u2009years with Autism Spectrum Disorder in existing child services', 'Incredible Years Autism Spectrum and Language Delays Parent Program', 'Parents of children aged 3-8\u2009years with a diagnosis of ASD, or strongly suspected ASD were eligible to participate', 'From October 5 to December 19, 2016, 58 families', ""four specialist children's services in Wales"", 'children with autism spectrum disorders (ASD']","['Incredible Years® Autism Spectrum and Language Delays (IY-ASLD) parent program immediately or to a wait-list, treatment as usual control condition', 'parenting program']","['feasibility (recruitment, retention, fidelity, and acceptability', 'Fidelity of delivery', 'Behavior problems']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",4.0,0.108766,This study examined the feasibility and acceptability of delivering a parenting program for parents of children aged 3-8 years with Autism Spectrum Disorder in existing child services.,"[{'ForeName': 'Margiad E', 'Initials': 'ME', 'LastName': 'Williams', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Hastings', 'Affiliation': 'CEDAR, Faculty of Social Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hutchings', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2265'] 870,31712321,Impaired Metabolic Flexibility to High-Fat Overfeeding Predicts Future Weight Gain in Healthy Adults.,"The ability to switch fuels for oxidation in response to changes in macronutrient composition of diet (metabolic flexibility) may be informative of individuals' susceptibility to weight gain. Seventy-nine healthy, weight-stable participants underwent 24-h assessments of energy expenditure and respiratory quotient (RQ) in a whole-room calorimeter during energy balance (EBL) (50% carbohydrate, 30% fat) and then during 24-h fasting and three 200% overfeeding diets in a crossover design. Metabolic flexibility was defined as the change in 24-h RQ from EBL during fasting and standard overfeeding (STOF) (50% carbohydrate, 30% fat), high-fat overfeeding (HFOF) (60% fat, 20% carbohydrate), and high-carbohydrate overfeeding (HCOF) (75% carbohydrate, 5% fat) diets. Free-living weight change was assessed after 6 and 12 months. Compared with EBL, RQ decreased on average by 9% during fasting and by 4% during HFOF but increased by 4% during STOF and by 8% during HCOF. A smaller decrease in RQ, reflecting a smaller increase in lipid oxidation rate, during HFOF but not during the other diets predicted greater weight gain at both 6 and 12 months. An impaired metabolic flexibility to acute HFOF can identify individuals prone to weight gain, indicating that an individual's capacity to oxidize dietary fat is a metabolic determinant of weight change.",2020,"Compared to EBL, RQ decreased on average by 9% during fasting and by 4% during HFOF, while increasing by 4% during STOF and by 8% during HCOF.","['Healthy Adults', 'Seventy-nine healthy, weight-stable participants underwent 24-h assessments of energy expenditure and respiratory quotient (RQ) in a whole-room calorimeter during energy balance (EBL; 50% carbohydrate, 30% fat) and then during 24-h fasting and three 200% overfeeding diets in a crossover design']",[],"['EBL, RQ', 'RQ', 'Free-living weight change', 'lipid oxidation rate', 'Metabolic flexibility', 'weight gain']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}]",[],"[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",79.0,0.0186324,"Compared to EBL, RQ decreased on average by 9% during fasting and by 4% during HFOF, while increasing by 4% during STOF and by 8% during HCOF.","[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Begaye', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Karyne L', 'Initials': 'KL', 'LastName': 'Vinales', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hollstein', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Core Laboratory, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Bogardus', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ paolo.piaggi@gmail.com paolo.piaggi@nih.gov.'}]",Diabetes,['10.2337/db19-0719'] 871,31815717,Evaluating the effectiveness of implementation intentions in a pedometer worksite intervention.,"BACKGROUND Pedometer-based worksite interventions have been found to be successful in increasing physical activity (PA) but adherence is challenging. OBJECTIVE To examine the use of Implementation Intentions (II), a self-regulatory skill, with self-monitoring with a pedometer to initiate behavior change as well as post-intervention adherence in a worksite wellness intervention. METHODS University employees (N = 54) participated in an 8-week pedometer-based intervention. A 2-arm randomized trial was used to compare the effectiveness of 1) only pedometers (PED) (n = 28) and 2) pedometers and II (PED+II) (n = 26) on PA. RESULTS Significant differences were observed between time points (p < .0001) but not between groups. Post-hoc pairwise comparisons between the time points revealed difference between Baseline and Week 4 (mean difference: 2446.9 steps/ day; p < 0.001), Week 4 and 12 (mean difference: 2956.3 steps/ day; p < 0.001), and Week 8 and 12 (mean difference: 2228.8 steps/ day; p = 0.005). CONCLUSION The PED+II group had higher step increases during the intervention indicating that the behavioral strategy was effective. However, participants in both groups had a significant decrease in steps from the end of the intervention to the delayed-post assessment highlighting the challenge to maintain behavioral changes post-intervention.",2019,"However, participants in both groups had a significant decrease in steps from the end of the intervention to the delayed-post assessment highlighting the challenge to maintain behavioral changes post-intervention.",['University employees (N\u200a=\u200a54) participated in an'],"['Pedometer-based worksite interventions', '1) only pedometers (PED) (n\u200a=\u200a28) and 2) pedometers and II (PED+II) (n\u200a=\u200a26) on PA', '8-week pedometer-based intervention']",[],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],,0.0433753,"However, participants in both groups had a significant decrease in steps from the end of the intervention to the delayed-post assessment highlighting the challenge to maintain behavioral changes post-intervention.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rinaldi-Miles', 'Affiliation': 'School of Kinesiology and Recreation, Illinois State University, Normal, IL, USA.'}, {'ForeName': 'Bhibha M', 'Initials': 'BM', 'LastName': 'Das', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Rumit Singh', 'Initials': 'RS', 'LastName': 'Kakar', 'Affiliation': 'School of Rehabilitation Sciences, Old Dominion University, Norfolk, VA, USA.'}]","Work (Reading, Mass.)",['10.3233/WOR-193039'] 872,31847246,Non-Energy-Restricted Low-Carbohydrate Diet Combined with Exercise Intervention Improved Cardiometabolic Health in Overweight Chinese Females.,"This study aimed to examine the effects of four weeks of a low-carbohydrate diet (LC) and incorporated exercise training on body composition and cardiometabolic health. Fifty-eight overweight/obese Chinese females (age: 21.2 ± 3.3 years, body mass index (BMI): 25.1 ± 2.8 kg/m 2 ) were randomly assigned to the control group (CON, n = 15), the LC control group (LC-CON, n = 15), the LC and high-intensity interval training group (LC-HIIT, n = 15), or the LC and moderate-intensity continuous training group (LC-MICT, n = 13). Subjects consumed a four week LC, whereas LC-HIIT and LC-MICT received extra training 5 d/week (LC-HIIT: 10 × 6 s cycling interspersed with 9 s rest, MICT: 30 min continuous cycling at 50-60% VO 2peak ). After intervention, the three LC groups demonstrated significant reductions in body weight (-2.85 kg in LC-CON, -2.85 kg in LC-HIIT, -2.56 kg in LC-MICT, p < 0.001, η 2 = 0.510), BMI ( p < 0.001, η 2 = 0.504) and waist-to-hip ratio ( p < 0.001, η 2 = 0.523). Groups with extra training (i.e., LC-HIIT and LC-MICT) improved VO 2peak by 14.8 and 17.3%, respectively. However, fasting glucose and blood lipid levels remained unchanged in all groups. Short-term LC is a useful approach to improve body composition in overweight/obese Chinese females. Incorporated exercise training has no additional effects on weight loss, but has additional benefits on cardiorespiratory fitness, and HIIT is more time efficient than the traditional MICT (2.5 min vs. 30 min).",2019,"After intervention, the three LC groups demonstrated significant reductions in body weight (-2.85 kg in LC-CON, -2.85 kg in LC-HIIT, -2.56 kg in LC-MICT, p < 0.001, η 2 = 0.510), BMI ( p < 0.001, η 2 = 0.504) and waist-to-hip ratio ( p < 0.001, η 2 = 0.523).","['Fifty-eight overweight/obese Chinese females (age: 21.2 ± 3.3 years, body mass index (BMI): 25.1 ± 2.8 kg/m 2 ', 'overweight/obese Chinese females', 'Overweight Chinese Females']","['LC control group (LC-CON, n = 15), the LC and high-intensity interval training group (LC-HIIT, n = 15), or the LC and moderate-intensity continuous training group (LC-MICT', 'exercise training', 'low-carbohydrate diet (LC) and incorporated exercise training', 'LC-HIIT', 'Non-Energy-Restricted Low-Carbohydrate Diet Combined with Exercise Intervention']","['body weight', 'BMI', 'Cardiometabolic Health', 'body composition', 'fasting glucose and blood lipid levels', 'body composition and cardiometabolic health', 'weight loss']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",58.0,0.0147271,"After intervention, the three LC groups demonstrated significant reductions in body weight (-2.85 kg in LC-CON, -2.85 kg in LC-HIIT, -2.56 kg in LC-MICT, p < 0.001, η 2 = 0.510), BMI ( p < 0.001, η 2 = 0.504) and waist-to-hip ratio ( p < 0.001, η 2 = 0.523).","[{'ForeName': 'Shengyan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Institute of Physical Education, Huzhou University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Faculty of Education, University of Macau, Macao 999078, China.'}, {'ForeName': 'Qingde', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao 999078, China.'}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Faculty of Education, University of Macau, Macao 999078, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'College of Physical Education, Hebei Normal University, Shijiazhuang 050000, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Education, University of Macau, Macao 999078, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute, Macao 999078, China.'}]",Nutrients,['10.3390/nu11123051'] 873,31757794,Effects of Pioglitazone on Glucose-Dependent Insulinotropic Polypeptide-Mediated Insulin Secretion and Adipocyte Receptor Expression in Patients With Type 2 Diabetes.,"Incretin hormone dysregulation contributes to reduced insulin secretion and hyperglycemia in patients with type 2 diabetes mellitus (T2DM). Resistance to glucose-dependent insulinotropic polypeptide (GIP) action may occur through desensitization or downregulation of β-cell GIP receptors (GIP-R). Studies in rodents and cell lines show GIP-R expression can be regulated through peroxisome proliferator-activated receptor γ (PPARγ) response elements (PPREs). Whether this occurs in humans is unknown. To test this, we conducted a randomized, double-blind, placebo-controlled trial of pioglitazone therapy on GIP-mediated insulin secretion and adipocyte GIP-R expression in subjects with well-controlled T2DM. Insulin sensitivity improved, but the insulinotropic effect of infused GIP was unchanged following 12 weeks of pioglitazone treatment. In parallel, we observed increased GIP-R mRNA expression in subcutaneous abdominal adipocytes from subjects treated with pioglitazone. Treatment of cultured human adipocytes with troglitazone increased PPARγ binding to GIP-R PPREs. These results show PPARγ agonists regulate GIP-R expression through PPREs in human adipocytes, but suggest this mechanism is not important for regulation of the insulinotropic effect of GIP in subjects with T2DM. Because GIP has antilipolytic and lipogenic effects in adipocytes, the increased GIP-R expression may mediate accretion of fat in patients with T2DM treated with PPARγ agonists.",2020,"Insulin sensitivity improved, but the insulinotropic effect of infused GIP was unchanged following 12 weeks of pioglitazone treatment.","['subjects with T2DM', 'patients with T2DM treated with PPARγ agonists', 'patients with Type 2 Diabetes Mellitus (T2DM', 'Patients with Type 2 Diabetes', 'subjects with well controlled T2DM']","['placebo', 'troglitazone', 'pioglitazone', 'Pioglitazone']","['GIP-R mRNA expression', 'Insulin sensitivity', 'insulin secretion and hyperglycemia', 'GIP-mediated insulin secretion and adipocyte GIP-R expression', 'insulinotropic effect of infused GIP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245514', 'cui_str': 'troglitazone'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0206131', 'cui_str': 'Fat Cells'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}]",,0.0635476,"Insulin sensitivity improved, but the insulinotropic effect of infused GIP was unchanged following 12 weeks of pioglitazone treatment.","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Tharp', 'Affiliation': 'Department of Anesthesiology, University of Vermont Medical Center, Larner College of Medicine, University of Vermont, Burlington, VT.'}, {'ForeName': 'Dhananjay', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, VT.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sideleva', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, VT.'}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Deacon', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Elahi', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL richard.pratley@flhosp.org.'}]",Diabetes,['10.2337/db18-1163'] 874,31915696,Propofol Affects Optic Nerve Sheath Diameter less than Sevoflurane during Robotic Surgery in the Steep Trendelenburg Position.,"Background Robot-assisted laparoscopic radical prostatectomy (RLRP) can increase intracranial pressure (ICP) related to a change in position. Increasing ICP may result in various ocular complications, which are rare but serious, such as a corneal abrasion and ischemic optic neuropathy. We performed a prospective observational trial using ultrasonographic measurements to compare optic nerve sheath diameter (ONSD) related to ICP between patients who received either propofol or sevoflurane and underwent RLRP. Methods Thirty-two male patients scheduled to undergo RLRP were assigned into groups according to the anesthetic agent used (group P: propofol, n  = 16; group S: sevoflurane, n  = 16). ONSD, end-tidal partial pressure of CO 2 , and blood pressure were measured 10 min after induction of anesthesia (T0), 30 min (T1), 60 min (T2), and 90 min after changing to the steep Trendelenburg position and introducing a pneumoperitoneum (T3) and 10 min after returning the patient's position to supine (T4) during surgery. Results No significant differences were observed in the demographic data of the patients, surgery time, or intraoperative variables, including hemodynamic and respiratory variables, at any of the time points. The mean right ONSDs in the propofol and sevoflurane groups were 37.3 and 40.1 mm at 30 min ( p =0.003), respectively. The mean left ONSDs were 38.4 and 40.8 mm at 30 min ( p =0.021) after changing to the Trendelenburg position. The ONSDs between the two groups were significantly different during surgery. Conclusions ONSD increased more in the sevoflurane group than in the propofol group during RLRP. Intravenous anesthetics could alleviate the increase in ICP during RLRP.",2019,The mean left ONSDs were 38.4 and 40.8 mm at 30 min ( p =0.021) after changing to the Trendelenburg position.,['Methods\n\n\nThirty-two male patients scheduled to undergo RLRP'],"['\n\n\nRobot-assisted laparoscopic radical prostatectomy (RLRP', 'anesthetic agent used (group P: propofol, n \u2009=\u200916; group S: sevoflurane, n \u2009=\u200916', 'optic nerve sheath diameter (ONSD', 'propofol', 'propofol or sevoflurane and underwent RLRP', 'Propofol', 'sevoflurane', 'Sevoflurane']","['demographic data of the patients, surgery time, or intraoperative variables, including hemodynamic and respiratory variables', 'ICP', 'intracranial pressure (ICP', 'ONSD, end-tidal partial pressure of CO 2 , and blood pressure', 'mean right ONSDs', 'mean left ONSDs']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]",32.0,0.0436192,The mean left ONSDs were 38.4 and 40.8 mm at 30 min ( p =0.021) after changing to the Trendelenburg position.,"[{'ForeName': 'Yanghyun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Center, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Seomun', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Center, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Sungwoo', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Center, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Biostatistics Collaboration Team, Research Core Center, Research Institute, National Cancer Center, Gyeonggi-do, Republic of Korea.'}]",BioMed research international,['10.1155/2019/5617815'] 875,31100199,"The effect of intradialytic exercise twice a week on the physical capacity, inflammation, and nutritional status of dialysis patients: A randomized controlled trial.","INTRODUCTION Inactivity, uremia, and malnutrition in dialysis patients may lead to decreased muscle mass and physical capacity. As a preventative measure, dialysis patients are provided with an intradialytic exercise program. Our study aimed to determine the role of intradialytic exercise performed 2 times per week on physical capacity, inflammation, and nutritional status in dialysis patients and to determine which exercises are more suitable for this population. METHODS A randomized clinical trial in which participants were randomly assigned to 1 of 3 groups, i.e., a group of patients performing aerobic exercise, a group of patients performing a combination of aerobic and resistance exercise and the control group. The study was conducted at the Dialysis Unit of Dr. Cipto Mangunkusumo General Hospital, Jakarta for 12 weeks from February to May 2018. The inclusion criteria were dialysis patients aged over 18 years who had undergone routine dialysis for over 3 months. FINDINGS A total of one hundred twenty patients were included in the study. There was a significant increase in lower extremity strength in the group performing aerobic exercise and in the combined exercise group compared to the lower extremity strength of the control group. There was also a significant increase in the physical component score (PCS) of the KDQOL-SF™ instrument in the aerobic training and combination exercise groups compared to the PCS of the control group. No significant differences were found between the combination exercise group and the aerobic training group in any outcome. DISCUSSION Both types of exercise programs significantly increased the lower extremity muscle strength and the PCS of the quality of life index. Combination exercise was not more effective than aerobic exercise for dialysis patients.",2019,There was a significant increase in lower extremity strength in the group performing aerobic exercise and in the combined exercise group compared to the lower extremity strength of the control group.,"['dialysis patients aged over 18\u2009years who had undergone routine dialysis for over 3\u2009months', 'Dialysis Unit of Dr. Cipto Mangunkusumo General Hospital, Jakarta for 12\u2009weeks from February to May 2018', 'dialysis patients', 'A total of one hundred twenty patients were included in the study']","['aerobic training', 'aerobic exercise, a group of patients performing a combination of aerobic and resistance exercise and the control group', 'intradialytic exercise', 'intradialytic exercise program', 'aerobic exercise', 'Combination exercise']","['physical capacity, inflammation, and nutritional status', 'lower extremity strength', 'physical component score (PCS', 'lower extremity muscle strength and the PCS of the quality of life index', 'extremity strength']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]",120.0,0.0305706,There was a significant increase in lower extremity strength in the group performing aerobic exercise and in the combined exercise group compared to the lower extremity strength of the control group.,"[{'ForeName': '', 'Initials': '', 'LastName': 'Suhardjono', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Vidhia', 'Initials': 'V', 'LastName': 'Umami', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Deddy', 'Initials': 'D', 'LastName': 'Tedjasukmana', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Setiati', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12764'] 876,30626911,"A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.","NSI-189 is a novel neurogenic compound independent of monoamine reuptake pathways. This trial evaluated oral NSI-189 as monotherapy in major depressive disorder. To improve signal detection, the sequential-parallel comparison design (SPCD) was chosen. Two hundred and twenty subjects were randomized to NSI-189 40 mg daily, 80 mg daily, or placebo for 12 weeks. The primary outcome measure was the Montogmery Asberg Depression Rating Scale (MADRS). Secondary subject-rated measures included the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests. MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively). However, the 40 mg dose showed greater overall reduction in SDQ (pooled mean difference -8.2; Cohen's d for Stages 1 and 2 = -0.11 and -0.64, p = 0.04), and CPFQ scores (pooled mean difference -1.9; Cohen's d for Stages 1 and 2 = -0.28 and -0.47, p = 0.03) versus placebo, as well as QIDS-SR scores in Stage 2 of SPCD (-2.5; Cohen's d Stages 1 and 2 = -0.03 and -0.68, p = 0.04). The 40 mg dose also showed advantages on some objective cognitive measures of the CogScreen (absolute Cohen's d ranged between 0.12 and 1.12 in favor of NSI-189, p values between 0.002 and 0.048 for those with overall significance), but not the Cogstate test. Both doses were well tolerated. These findings replicate those of phase 1b study, and warrant further exploration of the antidepressant and pro-cognitive effects of NSI-189.",2020,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","['major depressive disorder', 'Two hundred and twenty subjects were randomized to NSI-189 40', 'outpatients with major depressive disorder']","['NSI-189 phosphate', 'NSI-189', 'placebo']","['Montogmery Asberg Depression Rating Scale (MADRS', 'MADRS score reduction', 'Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests', 'QIDS-SR scores', 'tolerated', 'overall reduction in SDQ', 'objective cognitive measures of the CogScreen', 'CPFQ scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",220.0,0.16936,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA. gpapakostas@partners.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johe', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hand', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corp., Saint Petersburg, Florida, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kashambwa', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martinson', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0334-8'] 877,31833064,A pilot randomised controlled trial of the management of systolic blood pressure during endovascular thrombectomy for acute ischaemic stroke.,"It is unknown whether systolic blood pressure augmentation during endovascular thrombectomy improves clinical outcomes. This pilot randomised controlled trial aimed to assess the feasibility of differential systolic blood pressure targeting during endovascular thrombectomy procedures for anterior circulation ischaemic stroke. Fifty-one eligible patients fulfilling the national criteria for endovascular thrombectomy were randomly assigned to receive either standard or augmented systolic blood pressure management from the start of anaesthesia to recanalisation of the target vessel. Systolic blood pressure targets for the standard and augmented groups were 130-150 mmHg and 160-180 mmHg, respectively. The study achieved all feasibility targets, including a recruitment rate of 3.5 participants per week and median (IQR [range]) of mean systolic blood pressure separation between groups of 139 (135-143 [115-154]) vs. 167 (150-175 [113-188]) mmHg, p < 0.001. Data completeness was 99%. Independent functional recovery at 90 days (modified Rankin Scale 0, 1 or 2) was achieved in 30 (59%) patients, which is consistent with previously published data. There were no safety concerns with trial procedures. In conclusion, a large randomised controlled efficacy trial of standard vs. augmented systolic blood pressure management during endovascular thrombectomy is feasible.",2020,"Independent functional recovery at 90 days (modified Rankin Scale 0, 1 or 2) was achieved in 30 (59%) patients, which is consistent with previously published data.","['acute ischaemic stroke', 'anterior circulation ischaemic stroke', 'Fifty-one eligible patients fulfilling the national criteria for endovascular thrombectomy']","['differential systolic blood pressure targeting during endovascular thrombectomy procedures', 'standard vs. augmented systolic blood pressure management', 'standard or augmented systolic blood pressure management']","['mean systolic blood pressure separation', 'Systolic blood pressure targets', 'systolic blood pressure augmentation', 'systolic blood pressure']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]",51.0,0.154022,"Independent functional recovery at 90 days (modified Rankin Scale 0, 1 or 2) was achieved in 30 (59%) patients, which is consistent with previously published data.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Diprose', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Eom', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Robertson', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Short', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brew', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Caldwell', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'McGuinness', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Barber', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}]",Anaesthesia,['10.1111/anae.14940'] 878,31672941,Athletes feature greater rates of muscle glucose transport and glycogen synthesis during lipid infusion.,"BACKGROUNDInsulin resistance results from impaired skeletal muscle glucose transport/phosphorylation, linked to augmented lipid availability. Despite greater intramuscular lipids, athletes are highly insulin sensitive, which could result from higher rates of insulin-stimulated glycogen synthesis or glucose transport/phosphorylation and oxidation. Thus, we examined the time course of muscle glycogen and glucose-6-phosphate concentrations during low and high systemic lipid availability.METHODSEight endurance-trained and 9 sedentary humans (VO2 peak: 56 ± 2 vs. 33 ± 2 mL/kg/min, P < 0.05) underwent 6-hour hyperinsulinemic-isoglycemic clamp tests with infusions of triglycerides or saline in a randomized crossover design. Glycogen and glucose-6-phosphate concentrations were monitored in vastus lateralis muscles using 13C/31P magnetic resonance spectroscopy.RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants. During Intralipid infusion, insulin sensitivity remained higher in the athletes (ΔRd: 25 ± 3 vs. 17 ± 3 μmol/kg/min, P < 0.05), supported by higher glucose transporter type 4 protein expression than in sedentary humans. Compared to saline infusion, AUC of glucose-6-phosphate remained unchanged during Intralipid infusion in athletes (1.6 ± 0.2 mmol/L vs. 1.4 ± 0.2 [mmol/L] × h, P = n.s.) but tended to decrease by 36% in sedentary humans (1.7 ± 0.4 vs. 1.1 ± 0.1 [mmol/L] × h, P < 0.059). This drop was accompanied by a 72% higher rate of net glycogen synthesis in the athletes upon Intralipid infusion (47 ± 9 vs. 13 ± 3 μmol/kg/min, P < 0.05).CONCLUSIONAthletes feature higher skeletal muscle glucose disposal and glycogen synthesis during increased lipid availability, which primarily results from maintained insulin-stimulated glucose transport with increased myocellular glucose-6-phosphate levels for subsequent glycogen synthesis.TRIAL REGISTRATIONClinicalTrials.gov NCT01229059.FUNDINGGerman Federal Ministry of Health (BMG).",2019,RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants.,[],"['endurance-trained and 9 sedentary humans (VO2 peak: 56 ± 2 vs. 33 ± 2 mL/kg/min, P < 0.05) underwent 6-hour hyperinsulinemic-isoglycemic clamp tests with infusions of triglycerides or saline']","['Glycogen and glucose-6-phosphate concentrations', 'insulin sensitivity', 'time course of muscle glycogen and glucose-6-phosphate concentrations', 'AUC of glucose-6-phosphate', 'insulin-stimulated glucose disposal rate (Rd', 'net glycogen synthesis', 'muscle glucose transport and glycogen synthesis']",[],"[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0672761', 'cui_str': 'glycerol-6-phosphate transporter'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}]",,0.0359948,RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants.,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Begovatz', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bierwagen', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Schaart', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}]",JCI insight,['10.1172/jci.insight.127928'] 879,31441328,"Outcomes of a Weight Loss Intervention to Prevent Diabetes Among Low-Income Residents of East Harlem, New York.","There is a need for diabetes prevention efforts targeting vulnerable populations. Our community-academic partnership, the East Harlem Partnership for Diabetes Prevention, conducted a randomized controlled trial to study the impact of peer led diabetes prevention workshops on weight and diabetes risk among an economically and racially diverse population in East Harlem, New York. We recruited overweight/obese adults from more than 50 community sites and conducted oral glucose tolerance testing and completed other clinical assessments and a health and lifestyle survey. We randomized prediabetic participants to intervention or delayed intervention groups. Intervention participants attended eight 90-minute peer-led workshop sessions at community sites. Participants in both groups returned for follow-up assessments 6 months after randomization. The main outcomes were the proportion of participants who achieved 5% weight loss, percentage weight loss, and change in the probability of developing diabetes over the next 7.5 years according to the San Antonio Diabetes Prediction Model. We enrolled 402 participants who were mainly female (85%), Latino (73%) or Black (23%), foreign born (64%), and non-English speaking (58%). At 6 months, the intervention group lost a greater percentage of their baseline weight, had significantly lower rise in HbA1c (glycated hemoglobin), decreased risk of diabetes, larger decreases in fat and fiber intake, improved confidence in nutrition label reading, and decrease in sedentary behavior as compared with the control group. Thus, in partnership with community stakeholders, we created an effective low-resource program that was less intensive than previously studied programs by incorporating strategies to engage and affect our priority population.",2019,"At 6 months, the intervention group lost a greater percentage of their baseline weight, had significantly lower rise in HbA1c (glycated hemoglobin), decreased risk of diabetes, larger decreases in fat and fiber intake, improved confidence in nutrition label reading, and decrease in sedentary behavior as compared with the control group.","['recruited overweight/obese adults from more than 50 community sites and conducted oral glucose tolerance testing and completed other clinical assessments and a health and lifestyle survey', 'Low-Income Residents of East Harlem, New York', 'weight and diabetes risk among an economically and racially diverse population in East Harlem, New York', '402 participants who were mainly female (85%), Latino (73%) or Black (23%), foreign born (64%), and non-English speaking (58']","['peer led diabetes prevention workshops', 'Weight Loss Intervention']","['percentage of their baseline weight', 'proportion of participants who achieved 5% weight loss, percentage weight loss, and change in the probability of developing diabetes', 'rise in HbA1c (glycated hemoglobin', 'Diabetes', 'risk of diabetes, larger decreases in fat and fiber intake, improved confidence in nutrition label reading, and decrease in sedentary behavior']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0424661', 'cui_str': 'Percentage weight loss (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}]",402.0,0.0369741,"At 6 months, the intervention group lost a greater percentage of their baseline weight, had significantly lower rise in HbA1c (glycated hemoglobin), decreased risk of diabetes, larger decreases in fat and fiber intake, improved confidence in nutrition label reading, and decrease in sedentary behavior as compared with the control group.","[{'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Mayer', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Vangeepuram', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kezhen', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hanlen-Rosado', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Guedy', 'Initials': 'G', 'LastName': 'Arniella', 'Affiliation': 'Institute for Family Health, New York, NY, USA.'}, {'ForeName': 'Rennie', 'Initials': 'R', 'LastName': 'Negron', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Fox', 'Affiliation': 'Rockefeller College of Public Affairs and Policy, University at Albany, State University of New York, Albany, NY, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lorig', 'Affiliation': 'Self-Management Resource Center, Palo Alto, CA, USA.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119868232'] 880,31894603,"A multicenter, prospective, randomized trial of pain and discomfort during maxillary expansion: Leaf expander versus hyrax expander.","BACKGROUND Pain suffered by the young patient is the most frequent symptom during orthodontic treatment and is the one that most frightens children and causes worry in their families. AIM To investigate pain perception and function impairment during the first week of activation of two palatal expansion screws. DESIGN A total of 101 subjects were randomly divided into two groups: RME group included patients treated with the standard hyrax expansion screw and LEAF group included patients treated with Leaf Expander appliance. Pain intensity was assessed via the Wong-Baker scale. A questionnaire on oral function impairments was also compiled by the patients. RESULTS The Pain Scale analysis showed that patients in the RME group suffered from a significantly higher level of pain than those in the LEAF group (88.6% vs 25%, P < .01). RME group showed highest pain indexes from day 1 to day 4 (51.4% RME vs 9.7% LEAF suffered at least once from strong pain in the first 4 days, P < .01). Furthermore, oral functions were similarly affected in both groups. CONCLUSIONS Pain reported during maxillary arch expansion is influenced by clinical activation protocol and by the screw type. Patients treated with Leaf Expander reported significantly lower pain level in the first 7 days of treatment.",2020,RME group showed highest pain indexes from day 1 to day 4,['101 subjects'],"['RME', 'standard hyrax\xa0expansion screw and LEAF group included patients treated with Leaf Expander appliance', 'LEAF']","['pain Scale analysis', 'level of pain', 'pain level', 'Pain intensity', 'highest pain indexes', 'pain perception and function impairment', 'oral function impairments']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020696', 'cui_str': 'Hyraxes'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0242724', 'cui_str': 'Plant Leaves'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243112'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",101.0,0.0236439,RME group showed highest pain indexes from day 1 to day 4,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ugolini', 'Affiliation': 'Department of Surgical and Diagnostic Sciences, University of Genova, Genoa, Italy.'}, {'ForeName': 'Gianguido', 'Initials': 'G', 'LastName': 'Cossellu', 'Affiliation': 'Department of Biomedical Surgical and Dental Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Farronato', 'Affiliation': 'Department of Biomedical Surgical and Dental Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Silvestrini-Biavati', 'Affiliation': 'Department of Surgical and Diagnostic Sciences, University of Genova, Genoa, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Lanteri', 'Affiliation': 'Department of Biomedical Surgical and Dental Sciences, University of Milan, Milan, Italy.'}]",International journal of paediatric dentistry,['10.1111/ipd.12612'] 881,31928085,Scandcleft Project Trial 3: Comparison of Speech Outcomes in Relation to Sequence in 2-Stage Palatal Repair Procedures in 5-Year-Olds With Unilateral Cleft Lip and Palate.,"OBJECTIVE To compare speech outcome following different sequencing of hard and soft palate closure between arms and centers within trial 3 and compare results to peers without cleft palate. DESIGN A prospective randomized clinical trial. SETTING Two Norwegian and 2 British centers. PARTICIPANTS One hundred thirty-six 5-year-olds with unilateral cleft lip and palate were randomized to either lip and soft palate closure at 3 to 4 months and hard palate closure at 12 months (arm A) or lip and hard palate closure at 3 to 4 months and soft palate closure at 12 months (arm D). MAIN OUTCOME MEASURES A composite measure of velopharyngeal competence (VPC), overall assessment of VPC from connected speech (VPC-Rate). Percentage of consonants correct (PCC), active cleft speech characteristics (CSCs), subdivided by oral retracted and nonoral errors, and developmental speech characteristics (DSCs). RESULTS Across the trial, 47% had VPC, with no statistically significant difference between arms within or across centers. Thirty-eight percent achieved a PCC score of >90%, with no difference between arms or centers. In one center, significantly more children in arm A produced ≥3 active CSCs ( P < .05). Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D). CONCLUSIONS Less than half of the 5-year-olds achieved VPC and around one-third achieved age-appropriate PCC scores. Cleft speech characteristics were more common in arm A, but outcomes varied within and across centers. Thus, outcome of the same surgical method can vary substantially across centers.",2020,"Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D). ","['peers without cleft palate', 'One hundred thirty-six 5-year-olds with unilateral cleft lip and palate', '5-Year-Olds With Unilateral Cleft Lip and Palate', 'Two Norwegian and 2 British centers']","['lip and soft palate closure at 3 to 4 months and hard palate closure at 12 months ', 'lip and hard palate closure at 3 to 4 months and soft palate closure']","['PCC score', 'active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D', 'Percentage of consonants correct (PCC), active cleft speech characteristics (CSCs), subdivided by oral retracted and nonoral errors, and developmental speech characteristics (DSCs', 'velopharyngeal competence (VPC), overall assessment of VPC from connected speech (VPC-Rate']","[{'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0030219', 'cui_str': 'Velum Palatinum'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}]","[{'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.217497,"Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D). ","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Persson', 'Affiliation': 'Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Nina-Helen', 'Initials': 'NH', 'LastName': 'Pedersen', 'Affiliation': 'Statped Vest, Bergen, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hayden', 'Affiliation': 'The Royal Hospital for Sick Children, Belfast, Northern Ireland.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bowden', 'Affiliation': ""Greater Manchester Cleft Unit, Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Aukner', 'Affiliation': 'Department of Speech and Language Disorders, Statped sørøst, Oslo, Norway.'}, {'ForeName': 'Hallvard A', 'Initials': 'HA', 'LastName': 'Vindenes', 'Affiliation': 'Center for Cleft Lip and Palate, Bergen University Hospital Haukeland, Bergen, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Åbyholm', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Withby', 'Affiliation': ""Greater Manchester Cleft Unit, Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lohmander', 'Affiliation': 'Division of Speech and Language Pathology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619896637'] 882,30929283,Compassion Meditation for Posttraumatic Stress Disorder in Veterans: A Randomized Proof of Concept Study.,"There is considerable interest in developing complementary and integrative approaches for ameliorating posttraumatic stress disorder (PTSD). Compassion meditation (CM) and loving-kindness meditation appear to offer benefits to individuals with PTSD, including symptom reduction. The present study was a pilot randomized controlled trial of CM for PTSD in veterans. The CM condition, an adaptation of Cognitively-Based Compassion Training (CBCT®), consists of exercises to stabilize attention, develop present-moment awareness, and foster compassion. We compared CM to Veteran.calm (VC), which consists of psychoeducation about PTSD, rationale for relaxation, relaxation training, and sleep hygiene. Both conditions consist of 10 weekly 90-min group sessions with between-session practice assignments. A total of 28 veterans attended at least one session of the group intervention and completed pre- and posttreatment measures of PTSD severity and secondary outcomes as well as weekly measures of PTSD, depressive symptoms, and positive and negative emotions. Measures of treatment credibility, attendance, practice compliance, and satisfaction were administered to assess feasibility. A repeated measures analysis of variance revealed a more substantive reduction in PTSD symptoms in the CM condition than in the VC condition, between-group d = -0.85. Credibility, attendance, and satisfaction were similar across CM and VC conditions thus demonstrating the feasibility of CM and the appropriateness of VC as a comparison condition. The findings of this initial randomized pilot study provide rationale for future studies examining the efficacy and effectiveness of CM for veterans with PTSD.",2019,"A repeated measures analysis of variance revealed a more substantive reduction in PTSD symptoms in the CM condition than in the VC condition, between-group d = -0.85.","['Posttraumatic Stress Disorder in Veterans', 'veterans', '28 veterans', 'veterans with PTSD']","['CM', 'Compassion Meditation', 'Compassion meditation (CM) and loving-kindness meditation']","['PTSD, depressive symptoms, and positive and negative emotions', 'treatment credibility, attendance, practice compliance, and satisfaction', 'PTSD symptoms', 'Credibility, attendance, and satisfaction']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0150277'}, {'cui': 'C0024028', 'cui_str': 'Love'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",28.0,0.0234825,"A repeated measures analysis of variance revealed a more substantive reduction in PTSD symptoms in the CM condition than in the VC condition, between-group d = -0.85.","[{'ForeName': 'Ariel J', 'Initials': 'AJ', 'LastName': 'Lang', 'Affiliation': 'VA San Diego Center of\xa0Excellence for Stress and Mental Health, San Diego, California, USA.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Malaktaris', 'Affiliation': 'VA San Diego Center of\xa0Excellence for Stress and Mental Health, San Diego, California, USA.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Casmar', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Selena A', 'Initials': 'SA', 'LastName': 'Baca', 'Affiliation': 'Veterans Medical Research Foundation, San Diego, California, USA.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Golshan', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Department of Religion, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lobsang', 'Initials': 'L', 'LastName': 'Negi', 'Affiliation': 'Department of Religion, Emory University, Atlanta, Georgia, USA.'}]",Journal of traumatic stress,['10.1002/jts.22397'] 883,30952158,Chloroquine Versus Dihydroartemisinin-Piperaquine With Standard High-dose Primaquine Given Either for 7 Days or 14 Days in Plasmodium vivax Malaria.,"BACKGROUND Primaquine is necessary for the radical cure of Plasmodium vivax malaria, but the optimum duration of treatment and best partner drug are uncertain. A randomized controlled trial was performed to compare the tolerability and radical curative efficacy of 7-day versus 14-day high-dose primaquine regimens (total dose 7mg/kg) with either chloroquine or dihydroartemisinin-piperaquine. METHODS Patients with uncomplicated P. vivax malaria on the Thailand-Myanmar border were randomized to either chloroquine (25mg base/kg) or dihydroartemisinin-piperaquine (dihydroartemisinin 7mg/kg and piperaquine 55mg/kg) plus primaquine, either 0.5 mg/kg/day for 14 days or 1 mg/kg/day for 7 days. Adverse events within 42 days and 1-year recurrence rates were compared and their relationship with day 6 drug concentrations assessed. RESULTS Between February 2012 and July 2014, 680 patients were enrolled. P. vivax recurrences (all after day 35) occurred in 80/654 (12%) patients; there was no difference between treatments. Compared to the 7-day primaquine groups the pooled relative risk of recurrence in the 14-day groups was 1.15 (95% confidence interval 0.7 to 1.8). Hematocrit reductions were clinically insignificant except in G6PD female heterozygotes, 2 of whom had hematocrit reductions to <23% requiring blood transfusion. CONCLUSION Radical cure should be deployed more widely. The radical curative efficacy in vivax malaria of 7-day high-dose primaquine is similar to the standard 14-day high-dose regimen. Chloroquine and dihydroartemisinin-piperaquine are both highly effective treatments of the blood stage infection. Quantitative point of care G6PD testing would ensure safe use of the 7-day high-dose primaquine regimen in G6PD heterozygous females. CLINICAL TRIALS REGISTRATION NCT01640574.",2019,The radical curative efficacy in vivax malaria of 7-day high-dose primaquine is similar to the standard 14-day high-dose regimen.,"['Patients with uncomplicated P. vivax malaria on the Thailand-Myanmar border', 'G6PD heterozygous females', 'Between February 2012 and July 2014, 680 patients were enrolled']","['Chloroquine Versus Dihydroartemisinin-Piperaquine With Standard High-dose Primaquine', 'chloroquine or dihydroartemisinin-piperaquine', 'Primaquine', '7-day versus 14-day high-dose primaquine', 'dihydroartemisinin-piperaquine (dihydroartemisinin 7mg/kg and piperaquine 55mg/kg) plus primaquine', 'chloroquine', 'primaquine', 'Chloroquine and dihydroartemisinin-piperaquine']","['hematocrit reductions', '1-year recurrence rates', 'Adverse events', 'P. vivax recurrences', 'tolerability and radical curative efficacy', 'relative risk of recurrence', 'Hematocrit reductions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024537', 'cui_str': 'Plasmodium vivax Malaria'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",680.0,0.229225,The radical curative efficacy in vivax malaria of 7-day high-dose primaquine is similar to the standard 14-day high-dose regimen.,"[{'ForeName': 'Cindy S', 'Initials': 'CS', 'LastName': 'Chu', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Aung Pyae', 'Initials': 'AP', 'LastName': 'Phyo', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Htun Htun', 'Initials': 'HH', 'LastName': 'Win', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Naw Pet', 'Initials': 'NP', 'LastName': 'Poe', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Widi', 'Initials': 'W', 'LastName': 'Yotyingaphiram', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Suradet', 'Initials': 'S', 'LastName': 'Thinraow', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Pornpimon', 'Initials': 'P', 'LastName': 'Wilairisak', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Rattanaporn', 'Initials': 'R', 'LastName': 'Raksapraidee', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Verena I', 'Initials': 'VI', 'LastName': 'Carrara', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Moo Kho', 'Initials': 'MK', 'LastName': 'Paw', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Jacher', 'Initials': 'J', 'LastName': 'Wiladphaingern', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Proux', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Bancone', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Kanlaya', 'Initials': 'K', 'LastName': 'Sriprawat', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Sue J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Atthanee', 'Initials': 'A', 'LastName': 'Jeeyapant', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Nosten', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy735'] 884,31577041,Short-term effects of hyaluronic acid on the subgingival microbiome in peri-implantitis: A randomized controlled clinical trial.,"BACKGROUND The aim of our study was to evaluate the effects of a hyaluronic acid (HA) gel at 45 days on the microbiome of implants with peri-implantitis with at least 1 year of loading. METHODS A randomized controlled trial was conducted in peri-implantitis patients. Swabs containing the samples were collected both at baseline and after 45 days of treatment. 16S rRNA sequencing techniques were used to investigate the effect of HA gel on the subgingival microbiome. RESULTS One hundred and eight samples of 54 patients were analyzed at baseline and after follow-up at 45 days. Three strata with different microbial composition were obtained in the samples at baseline, representing three main microbial consortia associated with peri-implantitis. Stratum 1 did not show any difference for any variable after treatment with HA, whereas in stratum 2, Streptococcus, Veillonella, Rothia, and Granulicatella did decrease (P < 0.05). Similarly, Prevotella and Campylobacter (P < 0.05) decreased in stratum 3 after treatment with HA. Microbial diversity was found to be decreased in stratum 3 (P < 0.05) after treatment with HA compared with the control group, in which an increase was found (P < 0.05). CONCLUSIONS HA reduced the relative abundance of peri-implantitis-related microorganisms, especially the early colonizing bacteria, suggesting a specific action during the first stages in the development of the disease. HA did not alter relative abundances of non-oral genera. The use of HA in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.",2020,"The use of hyaluronic acid in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.","['implants with peri-implantitis with at least one year of loading', 'peri-implantitis patients', 'peri-implantitis', '108 samples of 54 patients']","['hyaluronic acid', 'hyaluronic acid gel', 'Hyaluronic acid']","['microbial alpha diversity', 'Microbial diversity', 'relative abundances of non-oral genera']","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",,0.129597,"The use of hyaluronic acid in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Soriano-Lerma', 'Affiliation': 'Department of Physiology (Faculty of Pharmacy, Campus Universitario de Cartuja), Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Magán-Fernández', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gijón', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sánchez-Fernández', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Soriano', 'Affiliation': 'GENYO, Centre for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, PTS Granada, Granada, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'García-Salcedo', 'Affiliation': 'Microbiology Unit, Biosanitary Research Institute ibs.GRANADA, University Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Mesa', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}]",Journal of periodontology,['10.1002/JPER.19-0184'] 885,29696832,Progesterone administration does not acutely alter LH pulse secretion in the mid-follicular phase in women.,"It remains unclear how rapidly progesterone suppresses luteinizing hormone (LH) pulse frequency in women. Previous studies suggested that progesterone markedly increases LH pulse amplitude but does not slow LH pulse frequency within 10 h in estradiol-pretreated women studied during the late follicular phase. However, this experimental paradigm may be a model of preovulatory physiology, and progesterone may have different effects at other times of the cycle. We studied regularly cycling, nonobese women without hyperandrogenism to assess the acute effect of progesterone during the midfollicular phase and in the absence of estradiol pretreatment. The study involved two admissions in separate cycles (cycle days 5-9). For each admission, either oral micronized progesterone (100 mg) or placebo was administered at 0900 h in a randomized, double-blind fashion. Frequent blood sampling was performed between 0900 and 1900 h to define 10-h LH pulsatility. Treatment crossover (placebo exchanged for progesterone and vice versa) occurred in a subsequent cycle. After an interim futility analysis, the study was halted after 7 women completed study. Mean progesterone concentrations after placebo and progesterone administration were 0.5 ± 0.1 (mean ± SD) and 6.7 ± 1.6 ng/mL, respectively. Compared to placebo, progesterone was not associated with a significant difference in 10-h LH pulse frequency (0.79 ± 0.35 vs. 0.77 ± 0.28 pulses/h, P = 1.0) or amplitude (3.6 ± 2.8 vs. 4.3 ± 2.8 IU/L, P = 0.30). This study suggests that LH pulse frequency is not rapidly influenced by progesterone administration during the midfollicular phase.",2018,"Compared to placebo, progesterone was not associated with a significant difference in 10-h LH pulse frequency (0.79 ± 0.35 vs. 0.77 ± 0.28 pulses/h, P = 1.0) or amplitude (3.6 ± ","['nonobese women without hyperandrogenism', 'women']","['placebo', 'placebo, progesterone', 'progesterone', 'oral micronized progesterone', 'Progesterone', 'placebo and progesterone']","['Mean progesterone concentrations', 'slow LH pulse frequency', 'LH pulse secretion', 'LH pulse amplitude', 'luteinizing hormone (LH) pulse frequency', 'LH pulse frequency', '10-h LH pulse frequency']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenism'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}]",,0.211199,"Compared to placebo, progesterone was not associated with a significant difference in 10-h LH pulse frequency (0.79 ± 0.35 vs. 0.77 ± 0.28 pulses/h, P = 1.0) or amplitude (3.6 ± ","[{'ForeName': 'Su Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Burt Solorzano', 'Affiliation': 'Center for Research in Reproduction, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'McCartney', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia School of Medicine, Charlottesville, Virginia.'}]",Physiological reports,['10.14814/phy2.13680'] 886,31793162,Comparing the learning effects of debriefing modalities for the care of premature infants.,"The aim of this study was to compare the learning effects of debriefing methods used in the simulation of prematurity care by measuring: (i) academic self-efficacy; (ii) confidence in performance; (iii) self-assessed communication skills; and (iv) satisfaction. We employed a quasi-experimental design with three experimental groups that experienced instructor-directed, self-directed, and video-assisted, self-directed debriefing, respectively. Participants were 146 senior nursing students from three nursing schools. To compare learning effects, the same developed scenario for prematurity care was applied to all three groups. Significant differences were observed in the mean scores for the study variables among the three groups. The post-hoc analysis showed that the video-assisted, self-directed debriefing group obtained the highest mean score difference for confidence in performance, self-assessed communication skills, and satisfaction with the debriefing method. Thus, video-assisted, self-directed debriefing could be the most effective debriefing method for students.",2020,Significant differences were observed in the mean scores for the study variables among the three groups.,"['premature infants', 'Participants were 146 senior nursing students from three nursing schools']",[],"['prematurity care by measuring: (i) academic self-efficacy; (ii) confidence in performance; (iii) self-assessed communication skills; and (iv) satisfaction', 'performance, self-assessed communication skills, and satisfaction', 'mean scores']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0036380', 'cui_str': 'Nurse Training Schools'}]",[],"[{'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",146.0,0.0164641,Significant differences were observed in the mean scores for the study variables among the three groups.,"[{'ForeName': 'Myung-Nam', 'Initials': 'MN', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kangwon National University, Samcheok, Korea.'}, {'ForeName': 'Shin-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, Hallym University, Chuncheon, Korea.'}, {'ForeName': 'Kyung-Ah', 'Initials': 'KA', 'LastName': 'Kang', 'Affiliation': 'College of Nursing, Sahmyook University, Seoul, Korea.'}, {'ForeName': 'Sunghee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul, Korea.'}]",Nursing & health sciences,['10.1111/nhs.12662'] 887,31532029,"Ketamine effects on default mode network activity and vigilance: A randomized, placebo-controlled crossover simultaneous fMRI/EEG study.","In resting-state functional connectivity experiments, a steady state (of consciousness) is commonly supposed. However, recent research has shown that the resting state is a rather dynamic than a steady state. In particular, changes of vigilance appear to play a prominent role. Accordingly, it is critical to assess the state of vigilance when conducting pharmacodynamic studies with resting-state functional magnetic resonance imaging (fMRI) using drugs that are known to affect vigilance such as (subanesthetic) ketamine. In this study, we sought to clarify whether the previously described ketamine-induced prefrontal decrease of functional connectivity is related to diminished vigilance as assessed by electroencephalography (EEG). We conducted a randomized, double-blind, placebo-controlled crossover study with subanesthetic S-Ketamine in N = 24 healthy, young subjects by simultaneous acquisition of resting-state fMRI and EEG data. We conducted seed-based default mode network functional connectivity and EEG power spectrum analyses. After ketamine administration, decreased functional connectivity was found in medial prefrontal cortex whereas increased connectivities were observed in intraparietal cortices. In EEG, a shift of energy to slow (delta, theta) and fast (gamma) wave frequencies was seen in the ketamine condition. Frontal connectivity is negatively related to EEG gamma and theta activity while a positive relationship is found for parietal connectivity and EEG delta power. Our results suggest a direct relationship between ketamine-induced functional connectivity changes and the concomitant decrease of vigilance in EEG. The observed functional changes after ketamine administration may serve as surrogate end points and provide a neurophysiological framework, for example, for the antidepressant action of ketamine (trial name: 29JN1556, EudraCT Number: 2009-012399-28).",2020,"In EEG, a shift of energy to slow (delta, theta) and fast (gamma) wave frequencies was seen in the ketamine condition.","['N = 24 healthy, young subjects by simultaneous acquisition of resting-state fMRI and EEG data']","['placebo', 'ketamine', 'Ketamine', 'subanesthetic S-Ketamine']","['shift of energy to slow (delta, theta) and fast (gamma) wave frequencies', 'medial prefrontal cortex', 'functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",24.0,0.0489139,"In EEG, a shift of energy to slow (delta, theta) and fast (gamma) wave frequencies was seen in the ketamine condition.","[{'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Zacharias', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Musso', 'Affiliation': 'Department of Psychiatry, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lammers', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Saleh', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie und Kinderradiologie, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'London', 'Affiliation': 'Early Development and Clinical Pharmacology, Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Boer', 'Affiliation': 'Janssen Pharmaceutica, Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Winterer', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",Human brain mapping,['10.1002/hbm.24791'] 888,31791663,Intravitreal Combined Aflibercept + Anti-Platelet-Derived Growth Factor Receptor β for Neovascular Age-Related Macular Degeneration: Results of the Phase 2 CAPELLA Trial.,"PURPOSE To compare the efficacy and safety of intravitreal aflibercept + anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). DESIGN Phase 2, randomized, double-masked study. PARTICIPANTS A total of 505 patients (eyes) with nAMD. METHODS Patients were randomized 1:2:2 to low-dose combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone every 4 weeks through week 12. At week 12, patients in the HD combo and IAI groups were re-randomized to continue as assigned or switch to HD combo → IAI or IAI → HD combo and dosed every 4 weeks through week 28. During weeks 28 to 52, patients received treatment as needed per prespecified criteria. This report presents efficacy through week 28 and safety through week 52. MAIN OUTCOME MEASURES Mean best-corrected visual acuity (BCVA) change from baseline at week 12 (primary end point). RESULTS At week 12, mean BCVA gains from baseline were 5.8, 5.8, and 7.5 letters with LD combo, HD combo, and IAI, respectively (P = 0.21 for LD combo and P = 0.10 for HD combo vs. IAI). The corresponding proportions of eyes that gained ≥15 letters were 12%, 19%, and 22%, respectively. Mean reductions in central retinal thickness from baseline were 126.1, 127.1, and 126.9 μm, respectively. Proportions of eyes with complete resolution of fluid from baseline were 35%, 24%, and 42%, respectively. Vision and anatomic outcomes at week 28 were consistent with the week 12 results. Through week 52, the incidence of intraocular inflammation was 1.0%, 7.5%, 2.1%, 2.1%, and 0%, respectively. The incidence of Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events was 1.9%, 0.9%, 1.1%, 2.1%, and 1.9%, respectively. CONCLUSIONS Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone. Anatomic outcomes evaluating complete fluid resolution favored IAI. Adverse events were consistent with the reported IAI safety profile, except for a higher frequency of intraocular inflammation in the HD combo group.",2020,"CONCLUSIONS Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone.","['Patients', 'A total of 505 patients (eyes) with nAMD', 'Neovascular Age-Related Macular Degeneration', 'patients with treatment-naïve neovascular age-related macular degeneration (nAMD']","['Intravitreal Combined Aflibercept\xa0+ Anti-Platelet-Derived Growth Factor Receptor β', 'intravitreal aflibercept\xa0+ anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy', 'combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone']","['Mean reductions in central retinal thickness', 'intraocular inflammation', 'Mean best-corrected visual acuity (BCVA) change', ""incidence of Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events"", 'efficacy and safety', 'Adverse events', 'mean BCVA gains', 'incidence of intraocular inflammation', 'BCVA', 'Vision and anatomic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0071253', 'cui_str': 'Platelet-Derived Growth Factor Receptor'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]",505.0,0.165178,"CONCLUSIONS Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone.","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kitchens', 'Affiliation': 'Retina Associates of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'Retina Research Institute of Texas, Abilene, Texas.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vitti', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Lorah', 'Initials': 'L', 'LastName': 'Perlee', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Chu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leal', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Asmus', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Son', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmelter', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas. Electronic address: dmbmd@houstonretina.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.021'] 889,31934593,"The Effects of Nurse-Led Multidisciplinary Team Management on Glycosylated Hemoglobin, Quality of Life, Hospitalization, and Help-Seeking Behavior of People with Diabetes Mellitus.","Aim To evaluate the effect of community-nurse-led multidisciplinary team management on glycosylated hemoglobin (HbA1c), quality of life (QOL), hospitalization, and help-seeking behavior in people with type 2 diabetes mellitus (DM). Methods A quasi-experimental trial was conducted among people with type 2 DM from two community centers in China. The intervention group ( n = 88) received community-nurse-led multidisciplinary team management for 2 years, while the control group ( n = 91) received usual care. Data regarding HbA1c, QOL (assessed by the SF-36), hospitalization, and help-seeking behavior were collected at baseline and at 6, 12, and 24 months. Results During the 24-month project, the intervention group demonstrated 1.08% reduction in HbA1c, whereas the control group achieved an increase of 0.45%. The differences between the two groups were statistically significant ( P < 0.001). The intervention group showed greater increased in QOL scores (from 66.43 to 70.47, P < 0.001), more decrease in hospitalization (OR = 2.981, 95% CI: 1.016, 8.752 versus OR = 1.189, 95% CI: 0.411, 3.444; P = 0.028) when compared with the control group. The percentage increase of seeking help from nurses in the intervention group (from 12.5% to 57.3%, P < 0.001) was significantly greater than that in the control group after the intervention. Conclusions Nurse-led multidisciplinary team management is an effective intervention for improving glycemic control, QOL, hospitalization, and help-seeking behavior for people with DM in a community.",2019,"The intervention group showed greater increased in QOL scores (from 66.43 to 70.47, P < 0.001), more decrease in hospitalization (OR = 2.981, 95% CI: 1.016, 8.752 versus OR = 1.189, 95% CI: 0.411, 3.444; P = 0.028) when compared with the control group.","['people with type 2 DM from two community centers in China', 'People with Diabetes Mellitus', 'people with type 2 diabetes mellitus (DM']","['Nurse-Led Multidisciplinary Team Management', 'community-nurse-led multidisciplinary team management', 'community-nurse-led multidisciplinary team management for 2 years, while the control group ( n = 91) received usual care']","['Glycosylated Hemoglobin, Quality of Life, Hospitalization, and Help-Seeking Behavior', 'hospitalization', 'HbA1c, QOL (assessed by the SF-36), hospitalization, and help-seeking behavior', 'glycosylated hemoglobin (HbA1c), quality of life (QOL), hospitalization, and help-seeking behavior', 'QOL scores']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557521', 'cui_str': 'Community nurse (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0034380'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0697946,"The intervention group showed greater increased in QOL scores (from 66.43 to 70.47, P < 0.001), more decrease in hospitalization (OR = 2.981, 95% CI: 1.016, 8.752 versus OR = 1.189, 95% CI: 0.411, 3.444; P = 0.028) when compared with the control group.","[{'ForeName': 'Yunxia', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'West China Hospital/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Suzhen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'West China Hospital/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'West China Hospital/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': 'West China Hospital/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'West China Hospital/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Meilan', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Yulin Community Health Service Center, Chengdu, Sichuan Province, China.'}]",Journal of diabetes research,['10.1155/2019/9325146'] 890,31928313,In vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit in patients with acute exacerbations of chronic obstructive pulmonary disease.,"BACKGROUND Veno-venous extracorporeal carbon dioxide removal allows clearance of CO 2 from the blood and is becoming popular to enhance protective mechanical ventilation and assist in the management of acute exacerbations of chronic obstructive pulmonary disease, including the prevention of intubation. The main factor determining CO 2 transfer across a membrane lung for any given blood flow rate and venous CO 2 content is the sweep gas flow rate. The in vivo characteristics of CO 2 clearance using ultra-low blood flow devices in patients with acute exacerbations of chronic obstructive pulmonary disease has not been previously described. METHODS Patients commenced on extracorporeal carbon dioxide removal for acute exacerbations of chronic obstructive pulmonary disease recruited to a randomized controlled trial of non-invasive ventilation versus extracorporeal carbon dioxide removal had pre- and post-membrane circuit gases measured after each increment of sweep gas flow to allow calculation of the transmembrane CO 2 clearance. This was compared with the clearance reported by the device and also corrected to inlet PCO 2 to allow characterization of the CO 2 clearance of the device at different sweep gas flow rates. RESULTS CO 2 clearance was calculated using both the transmembrane CO 2 whole-blood content difference and CO 2 clearance reported by the device. The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2 of 0.92. The membrane CO 2 clearance was non-linear with nearly two thirds of total clearance achieved with sweep gas flow below 2 L/minute (VCO 2 of 40 ± 16.7 mL/minute) and a plateau above 5 L/minute sweep gas flow (VCO 2 64 ± 1 2.4 mL/minute). CONCLUSION The extracorporeal carbon dioxide removal device used in the study provides efficient clearance of CO 2 at low sweep flow rates which then plateaus. This has implications for how the device may be used in clinical practice, particularly during the weaning phase where the final discontinuation of the device may take longer than anticipated. (ClinicalTrials.gov: NCT02086084, registered 13 March 2014, https://clinicaltrials.gov/ct2/show/NCT02086084 ).",2020,The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2 of 0.92.,"['Patients commenced on', 'for acute exacerbations of chronic obstructive pulmonary disease', 'patients with acute exacerbations of chronic obstructive pulmonary disease']","['vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit', 'extracorporeal carbon dioxide removal device', 'non-invasive ventilation versus extracorporeal carbon dioxide removal had pre- and post-membrane circuit gases', 'ultra-low blood flow devices', 'extracorporeal carbon dioxide removal']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0398339', 'cui_str': 'Extracorporeal carbon dioxide removal (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",[],,0.210584,The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2 of 0.92.,"[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Barrett', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Camporota', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}]",Perfusion,['10.1177/0267659119896531'] 891,31926869,'Maths on the move': Effectiveness of physically-active lessons for learning maths and increasing physical activity in primary school students.,"OBJECTIVES This study evaluated the benefit of physically-active lessons for learning maths multiplication-tables. The impact of the intervention on general numeracy, physical activity (PA), aerobic fitness, body mass index (BMI) and school-day moderate to vigorous PA (MVPA) was also assessed. DESIGN Randomised controlled cross-over trial. METHOD Year 3 students (n=172, mean age 8.4±0.3 years, 48% male) were recruited from 10 classes across two urban primary schools. Participants were randomly assigned to a seated classroom (Classroom) group or physically-active lessons in the playground (Playground) and crossed over to the alternative condition in the subsequent school term. The 6-week intervention comprised 3×30min sessions/week. Multiplication-tables (teacher-designed test) and general maths (standardised test) were assessed pre- and post-intervention. Aerobic fitness was assessed via the shuttle-run. Pre- to post-intervention change scores were compared for analysis and effect sizes (ES) calculated. Total PA and MVPA were assessed with accelerometers in a subset of participants. RESULTS Multiplication scores improved significantly more in Playground than Classroom groups (ES=0.23; p=0.045), while no significant differences were observed in general numeracy (ES=0.05; p=0.66). Total PA and MVPA were substantially higher during Playground than Classroom lessons (ES: total PA=7.4, MVPA=6.5; p<0.001) but there were no differences in PA/MVPA between the groups throughout the rest of the school day. Aerobic fitness improved more in Playground than Classroom groups (ES=0.3; p<0.001) while the change in BMI was not different between groups (p=0.39). CONCLUSIONS Physically-active lessons may benefit the learning of maths multiplication-tables while favourably contributing to school-day PA/MVPA.",2020,"Aerobic fitness improved more in Playground than Classroom groups (ES=0.3; p<0.001) while the change in BMI was not different between groups (p=0.39). ","['Year 3 students (n=172, mean age 8.4±0.3 years, 48% male) were recruited from 10 classes across two urban primary schools', 'primary school students']","['physically-active lessons', 'seated classroom (Classroom) group or physically-active lessons in the playground (Playground) and crossed over to the alternative condition in the subsequent school term']","['Total PA and MVPA', 'Multiplication scores', 'general numeracy, physical activity (PA), aerobic fitness, body mass index (BMI) and school-day moderate to vigorous PA (MVPA', 'change in BMI', 'general numeracy', 'Aerobic fitness', 'PA/MVPA']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442596', 'cui_str': 'School playground (environment)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0580419,"Aerobic fitness improved more in Playground than Classroom groups (ES=0.3; p<0.001) while the change in BMI was not different between groups (p=0.39). ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vetter', 'Affiliation': 'Discipline of Exercise and Sport Science, Faculty of Medicine and Health Sciences, The University of Sydney, Camperdown NSW 2006, Australia. Electronic address: mvet2126@uni.sydney.edu.au.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': ""O'Connor"", 'Affiliation': 'Discipline of Exercise and Sport Science, Faculty of Medicine and Health Sciences, The University of Sydney, Camperdown NSW 2006, Australia; Charles Perkins Centre, The University of Sydney, Camperdown, NSW, 2006, Australia. Electronic address: helen.oconnor@sydney.edu.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': ""O'Dwyer"", 'Affiliation': 'Discipline of Exercise and Sport Science, Faculty of Medicine and Health Sciences, The University of Sydney, Camperdown NSW 2006, Australia. Electronic address: nicholas.odwyer@sydney.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chau', 'Affiliation': 'Department of Health Systems and Populations, Macquarie University, Level 3, 75 Talavera Road, NSW 2109, Australia. Electronic address: josephine.chau@mq.edu.au.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orr', 'Affiliation': 'Discipline of Exercise and Sport Science, Faculty of Medicine and Health Sciences, The University of Sydney, Camperdown NSW 2006, Australia; Charles Perkins Centre, The University of Sydney, Camperdown, NSW, 2006, Australia. Electronic address: rhonda.orr@sydney.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.12.019'] 892,31926951,Early gestational diabetes screening in obese women: a randomized controlled trial.,"BACKGROUND Although in 2013 the American College of Obstetricians and Gynecologists recommended early screening for gestational diabetes in obese women, no studies demonstrate an improvement in perinatal outcomes with this strategy. OBJECTIVE We sought to determine whether early screening for gestational diabetes improves perinatal outcomes in obese women. MATERIALS AND METHODS Randomized controlled trial comparing early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (body mass index ≥30 kg/m 2 ) at 2 tertiary care centers in the United States. Screening was performed using a 50-g, 1-hour glucose challenge test followed by a 100-g, 3-hour glucose tolerance test if the initial screen was ≥135 mg/dL. Gestational diabetes was diagnosed using Carpenter-Coustan criteria. Women not diagnosed at 14 to 20 weeks were rescreened at 24 to 28 weeks. Exclusion criteria were pre-existing diabetes, major medical illness, bariatric surgery, and prior cesarean delivery. The primary outcome was a composite of macrosomia (>4000 g), primary cesarean delivery, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth). RESULTS A total of 962 women were randomized, and outcomes were available for 922. Of these 922 women, 459 (49.8%) were assigned to early screen and 463 (50.2%) to routine screen. Baseline characteristics were balanced between groups. In the early screening group, 69 (15.0%; 95% confidence interval, 11.9-18.6%) were diagnosed with gestational diabetes: 29 (6.3%; 95% confidence interval, 4.3-8.9%) at <20 weeks and 40 (8.7%; 95% confidence interval, 6.3-11.7%) at >24 weeks. Of those randomized to routine screening, 56 (12.1%; 95% confidence interval, 9.3-15.4%) had gestational diabetes. Early screening did not reduce the incidence of the primary outcome (56.9% in the early screen versus 50.8% in the routine screen, P = .07; relative risk, 1.12; 95% confidence interval, 0.99-1.26). CONCLUSION Early screening for gestational diabetes in obese women did not reduce the composite perinatal outcome.",2020,"Early screening did not reduce the incidence of the primary outcome (56.9% in early screen vs 50.8% in routine screen, p=0.07, RR 1.12, 95% CI 0.99-1.26). ","['early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (BMI≥30 kg/m 2 ) at two tertiary care centers in the US', 'A total of 962 women', 'Early Gestational Diabetes Screening in Obese Women', 'obese women', 'gestational diabetes in obese women']",[],"['diagnosed with gestational diabetes', 'composite of macrosomia (>4000g), primary cesarean, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth', 'gestational diabetes']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",[],"[{'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0269825', 'cui_str': 'Shoulder girdle dystocia (disorder)'}, {'cui': 'C0857007', 'cui_str': 'Hyperbilirubinemia, Neonatal'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia (disorder)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",962.0,0.519412,"Early screening did not reduce the incidence of the primary outcome (56.9% in early screen vs 50.8% in routine screen, p=0.07, RR 1.12, 95% CI 0.99-1.26). ","[{'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL. Electronic address: lmharper@uabmc.edu.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jauk', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': ""Women's Services Center of Excellence, Ochsner Health System, New Orleans, LA.""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL; Women's Services Center of Excellence, Ochsner Health System, New Orleans, LA.""}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.021'] 893,31925529,Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial.,"BACKGROUND Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF. METHODS A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m 2 ). RESULTS At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35-1.98, p adj  = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61-1.11, p = 0.192, p int  = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71-1.71, p = 0.656, p int  = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (p int  = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (p int  = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF. CONCLUSIONS IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy. CLINICAL TRIAL REGISTRATION The trial has been registered with ClinicalTrials.gov, number NCT01813435.",2020,"There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy. ","['patients with IRF treated with ticagrelor monotherapy', 'after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate\u2009<\u200960']","['Ticagrelor', 'ticagrelor', 'ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin', 'ticagrelor monotherapy']","['rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization', 'BARC 3 or 5 type bleeding', 'rates of the primary endpoint or BARC 3 or 5 type bleeding', 'net adverse clinical events (POCE and BARC 3 or 5 type bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446165', 'cui_str': 'Immature reticulocyte fraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.145947,"There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy. ","[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus University Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Klimczak-Tomaniak', 'Affiliation': 'Department of Immunology, Transplantation and Internal Medicine, Department of Cardiology, Hypertension and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Xi'an, China.""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Xi'an, China.""}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rademaker-Havinga', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, The Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Curzen', 'Affiliation': 'University Hospital Southampton NHSF, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': 'Department of Cardiology, Städtische Kliniken Neuss, Neuss, Germany.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Kochman', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Deutsches Zentrum für Herz und Kreislauf Forschung, Standort Rhein-Main, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Cardiology Department, ACTION Study Group, Nîmes University Hospital, Montpellier University, Nîmes, France.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Capodanno', 'Affiliation': 'Division of Cardiology, A.O.U. ""Policlinico-Vittorio Emanuele"", University of Catania, Catania, Italy.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust, Cardiovascular Research Unit, Centre for Biomedical Research, Northern General Hospital, Sheffield, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Giessen, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'NHLI, Imperial College London, London, UK. patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'University Hospital of Wales, Cardiff, UK.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-019-01586-9'] 894,31925579,"Flurbiprofen axetil for postoperative analgesia in upper abdominal surgery: a randomized, parallel controlled, double-blind, multicenter clinical study.","PURPOSE To investigate the efficacy and safety of flurbiprofen axetil in postoperative analgesia in upper abdominal surgery. METHODS This was a multicenter, randomized, positive drug parallel controlled double-blind clinical study. Patients undergoing upper abdominal surgery were randomly divided to receive flurbiprofen axetil or tramadol. The VAS pain scores at rest and on coughing (pulmonary function training) were assessed immediately before drug usage (T1) to evaluate the efficacy of postoperative analgesia. Repeat assessment of the VAS was performed after T1. The timing of the recovery of the gastrointestinal function and the preoperative and postoperative IL-6, cortisol, and blood glucose levels were recorded as secondary endpoints. Vital signs and the occurrence of adverse reactions were evaluated for the assessment of safety. RESULTS A total of 240 patients were enrolled in the current study; 119 used flurbiprofen axetil for postoperative analgesia. The VAS scores at rest and on coughing did not differ between the two groups to a statistically significant extent (P > 0.05). However, the reduction of the VAS score at rest in the flurbiprofen axetil group was greater than that in the tramadol group at 4-24 h after T1. The reduction of the VAS score on coughing at 8 h after T1 was greater in the flurbiprofen axetil group. The incidence of adverse reactions was significantly lower in the flurbiprofen axetil group, with only one adverse reaction recorded. In contrast, 18 adverse reactions were reported in the tramadol group. CONCLUSION Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery. Flurbiprofen axetil was associated with a significantly lower incidence of adverse reactions in comparison to tramadol.",2020,Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery.,"['Patients undergoing upper abdominal surgery', '240 patients were enrolled in the current study; 119 used', 'early postoperative analgesia after upper abdominal surgery', 'upper abdominal surgery']","['flurbiprofen axetil or tramadol', 'flurbiprofen axetil', 'tramadol', 'Flurbiprofen axetil']","['adverse reactions', 'VAS pain scores at rest and on coughing (pulmonary function training', 'efficacy and safety', 'VAS scores at rest and on coughing', 'VAS score', 'VAS score on coughing', 'Vital signs and the occurrence of adverse reactions', 'incidence of adverse reactions', 'preoperative and postoperative IL-6, cortisol, and blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",240.0,0.0513386,Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery.,"[{'ForeName': 'Run-Dong', 'Initials': 'RD', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Anhui No. 2 Provincial People's Hospital, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Xu-Ren', 'Initials': 'XR', 'LastName': 'Sheng', 'Affiliation': ""Department of Liver Surgery, The First Affiliated Hospital of USTC, 17 Lujiang Road, Luyang, Hefei, Anhui, 230001, People's Republic of China.""}, {'ForeName': 'Wen-Xian', 'Initials': 'WX', 'LastName': 'Guan', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.""}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': ""Hepatological Surgery Department, Hunan Provincial People's Hospital, The First Hospital Affiliated with Hunan Normal University, Changsha, People's Republic of China.""}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""The Basic Surgical, Union Hospital Affiliated with Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': 'He-Guang', 'Initials': 'HG', 'LastName': 'Huang', 'Affiliation': ""The Basic Surgical, Union Hospital Affiliated with Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Ning-Li', 'Affiliation': ""Intestinal Microenvironment Treatment Center, Tenth People's Hospital of Tongji University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Jia', 'Affiliation': ""Department of Liver Surgery, The First Affiliated Hospital of USTC, 17 Lujiang Road, Luyang, Hefei, Anhui, 230001, People's Republic of China. jwd19680@sina.com.""}]",Surgery today,['10.1007/s00595-019-01951-1'] 895,31506246,Land- versus water-walking interventions in older adults: Effects on body composition.,"OBJECTIVES Increasing physical activity is a priority worldwide, including for older adults who may have difficulty performing traditional forms of exercise, and for whom retention of muscle mass is an important consideration. Water-based exercise may provide an alternative if benefits are comparable. We compared the impact on body composition of 24-week water- versus land-walking interventions in healthy but inactive older adults. DESIGN Randomised, controlled trial. METHODS 72 participants (62.5±6.8yr) were randomised to a land-walking (LW), water-walking (WW) or control (C) group in a supervised centre-based program. The exercise groups trained 3 times/week at matched intensity (%HRR), increasing from 40-45% to 55-65% heart rate reserve (HRR). Height, weight, body mass index (BMI), waist and hip girths were recorded; dual X-ray absorptiometry (DXA) provided fat and lean tissue masses. Participants were re-assessed 24 weeks after completion of the intervention. RESULTS There were no significant changes in body mass or BMI following either exercise protocol, however central adiposity was reduced in both exercise groups, and the WW group increased lower limb lean mass. These benefits did not persist over the follow-up period. CONCLUSIONS Exercise can confer beneficial effects on body composition which are not evident when examining weight or BMI. Both WW and LW improved body composition. Water walking can be recommended as an exercise strategy for this age group due to its beneficial effects on body composition which are similar to, or exceed, those associated with land-walking. For benefits to persist, it appears that exercise needs to be maintained.",2020,"There were no significant changes in body mass or BMI following either exercise protocol, however central adiposity was reduced in both exercise groups, and the WW group increased lower limb lean mass.","['72 participants (62.5±6.8yr', 'older adults', 'healthy but inactive older adults']","['Land- versus water-walking interventions', 'land-walking (LW), water-walking (WW) or control (C) group in a supervised centre-based program', '24-week water- versus land-walking interventions']","['body mass or BMI', 'Height, weight, body mass index (BMI), waist and hip girths', 'body composition', 'central adiposity', 'lower limb lean mass']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",72.0,0.0589762,"There were no significant changes in body mass or BMI following either exercise protocol, however central adiposity was reduced in both exercise groups, and the WW group increased lower limb lean mass.","[{'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Maslen', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia; School of Medicine, University of Western Australia, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Spence', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Australia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Robey', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Carter', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Australia; North Western Mental Health, Melbourne Health, Australia; School of Psychiatry & Clinical Neurosciences and WA Centre for Health & Ageing, University of Western Australia, Australia.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Australia.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of Western Australia, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia. Electronic address: danny.green@uwa.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.08.019'] 896,31871108,Effect of Vitamin D on Relapse-Free Survival in a Subgroup of Patients with p53 Protein-Positive Digestive Tract Cancer: A Post Hoc Analysis of the AMATERASU Trial.,"BACKGROUND The AMATERASU randomized trial of vitamin D3 supplementation (2,000 IU/day; UMIN000001977) showed the potential benefit of vitamin D in a subgroup of patients with digestive tract cancer. By conducting post hoc analyses of this trial, we further explored whether subgroups stratified by expression levels of p53, vitamin D receptor (VDR), and Ki-67 modify the effect of vitamin D supplementation. METHODS The primary outcome was relapse-free survival (RFS). On IHC using pathologic specimens, the degree of p53 protein expression parallel with TP53 missense mutations was classified as p53 positive (>10%) and p53 negative (≤10%). In addition, VDR and Ki-67 expression levels were divided into quartiles. RESULTS The p53 status of 372 patients' pathologic specimens was evaluated. In a subgroup of patients with p53-positive cancer ( n = 226), 5-year RFS was 79% in the vitamin D group, which was significantly higher than the 57% in the placebo group (HR, 0.52; 95% confidence interval, 0.31-0.88; P = 0.02). In the subgroup of patients with p53-negative cancer, 5-year RFS in the vitamin D group versus placebo group was 72% versus 84% (not significantly different), respectively. Effect modification by p53 positivity was significant ( P interaction = 0.02). However, no significant effect modification by either VDR or Ki-67 was observed. CONCLUSIONS These results generate a hypothesis that vitamin D supplementation may improve RFS in patients with p53-positive digestive tract cancer. IMPACT The results are still preliminary, but potentially important, because TP53 is the most frequently mutated gene across cancers at all sites.",2020,Effect modification by p53-positivity was significant (P=0.02 for interaction).,"['patients with digestive tract cancer', 'patients with p53 protein-positive digestive tract cancer', 'patients with p53-positive digestive tract cancer', ""372 patients' pathological specimens""]","['vitamin D supplementation', 'vitamin D3 supplementation', 'vitamin D', 'placebo']","['relapse-free survival', 'RFS', 'VDR or Ki-67', '5-year RFS', 'relapse-free survival (RFS', 'VDR and Ki-67 expression levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",372.0,0.272787,Effect modification by p53-positivity was significant (P=0.02 for interaction).,"[{'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Akutsu', 'Affiliation': 'Division of Molecular Epidemiology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Department of Pathology, International University of Health and Welfare Hospital, Otawara, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Hirooka', 'Affiliation': 'Department of Pathology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ikegami', 'Affiliation': 'Department of Pathology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ohdaira', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, Otawara, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, Otawara, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, The Jikei University School of Medicine, Tokyo, Japan. urashima@jikei.ac.jp.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0986'] 897,31743554,Novel topical skin hydration agent containing Anadenanthera colubrina polysaccharide-standardized herbal preparation.,"BACKGROUND Hydration is an important factor to promote skin barrier function, metabolism, and appearance. In this process, the presence of aquaglyceroporins, envelope and lipid synthesis, and metabolism proteins are essential to provide greater corneocyte cohesion and to form a barrier avoiding transepidermal water loss. OBJECTIVE We evaluated the effects of a new topical pigment-free agent containing an Anadenanthera colubrina polysaccharide-rich dermocosmetic preparation (ACP) on the aquaporin-3 (AQP-3), filaggrin (FLG), involucrin (INV), glucocerebrosidase (GBA), and elongation of very-long-chain fatty acid (ELOVL) proteins production in skin human fragments, as well as on the transepidermal water loss in a double-blind placebo-controlled clinical trial. METHODS AQP3, FLG, INV, GBA, and ELOVL3 levels were measured by immunofluorescence analysis in human skin explants. Clinical trial was conducted to evaluate the effects of ACP 1% and ACP 3% on the transepidermal water loss (TEWL). RESULTS Image and statistical analysis showed that ACP 3% significantly increased at 90% the expression of AQP3. Similarly, ACP 3% was able to promote a significant increase of 68% and 51% in FLG and INV, respectively. ACP 3% produced no effects on the GBA and ELOVL3 proteins. Transepidermal water loss was significantly reduced in human volunteers under treatment with ACP 1% and ACP 3%. CONCLUSION ACP reduced transepidermal water loss in a clinical trial, promoting human skin hydration. These effects were related to modulation of the AQP3, FLG, and INV as evidenced by immunofluorescence assay. This way, A colubrina polysaccharide-rich phytopharmaceutical preparation is an effective additive product to skin hydration.",2020,"These effects were related to modulation of the AQP3, FLG, and INV as evidenced by immunofluorescence assay.",['human volunteers'],"['new topical pigment-free agent containing an Anadenanthera colubrina polysaccharide-rich dermocosmetic preparation (ACP', 'ACP']","['transepidermal water loss', 'aquaporin-3 (AQP-3), filaggrin (FLG), involucrin (INV), glucocerebrosidase (GBA), and elongation of very-long-chain fatty acid (ELOVL) proteins production', 'FLG, INV, GBA, and ELOVL3 levels', 'Transepidermal water loss', 'GBA and ELOVL3 proteins', 'transepidermal water loss (TEWL']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0333610', 'cui_str': 'Pigmented (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1049796', 'cui_str': 'Colubrina'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0256421', 'cui_str': 'AQP3 Protein'}, {'cui': 'C0117738', 'cui_str': 'Stratum corneum basic protein'}, {'cui': 'C0063740', 'cui_str': 'involucrin'}, {'cui': 'C0017768', 'cui_str': 'Acid beta-Glucosidase'}, {'cui': 'C0542549', 'cui_str': 'Very long chain fatty acid (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033268'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0332107,"These effects were related to modulation of the AQP3, FLG, and INV as evidenced by immunofluorescence assay.","[{'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Katekawa', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Jeanifer', 'Initials': 'J', 'LastName': 'Caverzan', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mussi', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Flavio B', 'Initials': 'FB', 'LastName': 'Camargo-Junior', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Sufi', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Padovani', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Nazato', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nogueira', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Wagner V', 'Initials': 'WV', 'LastName': 'Magalhães', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Luiz C', 'Initials': 'LC', 'LastName': 'Di Stasi', 'Affiliation': 'Department of Pharmacology, Laboratory of Phytomedicines, Pharmacology and Biotechnology (PhytoPharmaTech), Institute of Biosciences, São Paulo State University (Unesp), Botucatu, Brazil.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13217'] 898,31828841,Randomised trial showed that rapid rehydration of severely malnourished children with dehydrating diarrhoea was as safe and effective as slow rehydration.,"AIM This study evaluated the effectiveness and safety of rapid and slow rehydration in children aged 6-60 months with dehydrating diarrhoea and severe malnutrition. METHODS A randomised controlled trial was conducted from July 2011 to March 2014 at the International Centre for Diarrhoeal Disease Research Bangladesh. We included children with weight for age and, or, weight for length Z-scores of less than -3 or with bipedal oedema and acute diarrhoea with severe dehydration. The children received intravenous fluid at different rates: 105 rapidly over six hours and 103 slowly over the 12 hours recommended by the World Health Organization. RESULTS All the children were successfully rehydrated. The admittance weights were similar for the slow and rapid groups: 8.4 kg and 8.3 kg. After 24 hours, the mean percentage weight gain was 8.5% and 9.0%, respectively. This confirmed that most of the children had been suffering from severe dehydration on admission. The respective proportions of children who received unscheduled intravenous fluid were 18% and 17%. None developed fluid overload or heart failure and most recovered normal renal function after rehydration. CONCLUSION Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.",2020,"CONCLUSION Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.","['July 2011 to March 2014 at the International Centre for Diarrhoeal Disease Research Bangladesh', 'children aged 6-60\xa0months with dehydrating diarrhoea and severe malnutrition', 'children with weight for age and, or, weight for length Z-scores of less than -3 or with bipedal oedema and acute diarrhoea with severe dehydration', 'severely malnourished children with dehydrating diarrhoea']","['rapid and slow rehydration', 'rapid rehydration']","['admittance weights', 'mean percentage weight gain', 'fluid overload or heart failure', 'normal renal function']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0035168'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C3472181', 'cui_str': 'Severe dehydration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0034997', 'cui_str': 'Rehydration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424660', 'cui_str': 'Percentage weight gain (observable entity)'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}]",105.0,0.33823,"CONCLUSION Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.","[{'ForeName': 'Nur H', 'Initials': 'NH', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ashraf', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nishat', 'Initials': 'N', 'LastName': 'Jahan', 'Affiliation': 'Department of Pharmacy, University of Asia Pacific, Dhaka, Bangladesh.'}, {'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Gyr', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15134'] 899,30122637,The Influence of the Instructional Approach on Acquiring Clinical Skills in Surgery: A Comparative Effectiveness Study.,"OBJECTIVE The instructional approach used to teach skills and competencies seems to have a critical impact on retaining and performing the learned skills/competencies. However, for most of them, the effect of different instructional approaches as well as evidence for appropriate approaches is unknown. The aim of the present study was to analyze and compare the impact of different instructional approaches in the acquisition of basic skills during undergraduate surgical training. DESIGN Randomized controlled cohort study. For the intervention, four instructional approaches ('See one - Do one', 'Video 4-Step Approach', 'Mental Group Mapping', and 'Control') were compared in six basic skills. Students completed a six-station OSCE (one for each skill) during their skills lab training week after the intervention. SETTING This study was conducted at the medical faculty of the Goethe University, Frankfurt, Germany. PARTICIPANTS Medical students in their fourth year completing their four week of obligatory surgical training. RESULTS A total of 151 students were included. The group 'Mental Group Mapping' scored significantly higher in comparison to 'See one - Do one' in four of the six skills and 'Control' in five skills. The group 'Video 4-Step Approach' scored significantly higher in comparison to 'See one - Do one' (three skills) in comparison to 'Control' (two skills). There were no significant differences between the approaches 'Mental Group Mapping' and 'Video 4-Step Approach' as well as between the approaches 'See one - Do one' and 'Control'. CONCLUSION Activating instructional approaches such as the '4-Step Approach' and 'Mental Group Mapping' have a significant impact on performing the learned skills and competencies.",2019,"There were no significant differences between the approaches 'Mental Group Mapping' and 'Video 4-Step Approach' as well as between the approaches 'See one - Do one' and 'Control'. ","['A total of 151 students were included', 'Surgery', 'Medical students in their fourth year completing their four week of obligatory surgical training', 'This study was conducted at the medical faculty of the Goethe University, Frankfurt, Germany']",['Instructional Approach'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0015537', 'cui_str': 'Faculty, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",[],151.0,0.0478837,"There were no significant differences between the approaches 'Mental Group Mapping' and 'Video 4-Step Approach' as well as between the approaches 'See one - Do one' and 'Control'. ","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ruesseler', 'Affiliation': 'Department of Trauma, Hand, and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: miriam.ruesseler@kgu.de.'}, {'ForeName': 'Mairen', 'Initials': 'M', 'LastName': 'Tomczak', 'Affiliation': 'Department of Trauma, Hand, and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: mairen@gmx.de.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thrun', 'Affiliation': 'Department of Trauma, Hand, and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: thrun.monika@gmail.com.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Pfau', 'Affiliation': 'Department of Trauma, Hand, and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: spfau@stud.uni-frankfurt.de.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Marzi', 'Affiliation': 'Department of Trauma, Hand, and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: marzi@trauma.uni-frankfurt.de.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Sterz', 'Affiliation': 'Department of Trauma, Hand, and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: jasmina.sterz@kgu.de.'}]",Journal of surgical education,['10.1016/j.jsurg.2018.07.008'] 900,31473464,Engaging Youth (Adolescents and Young Adults) to Change Frequent Marijuana Use: Motivational Enhancement Therapy (MET) in Primary Care.,"PURPOSE To characterize information elicited from adolescent/young adults with frequent cannabis use in Motivational Enhancement Therapy (MET), and determine whether differences exist across stages of change (SOC) for reducing use. DESIGN AND METHODS Primary care patients 15-24 years old using cannabis ≥3 times/week enrolled in a pilot randomized intervention trial. All youth were offered two 1-hour MET sessions. Content analysis was used to code and categorize main reasons for use, alternative behaviors, goals, values, pros and cons of change, and compared results between youth in Pre-Contemplation vs. Contemplation SOC. RESULTS Fifty-six youth completed MET session 1, 46 completed session 2. Most reported their main reason for use was related to emotional coping, negative feelings were a top-3 trigger, and distraction was an alternative way to meet their needs. Youth most frequently described progress in education or career/job as 1-year goals. More than half identified family as a very important value. They most frequently reported pros of using less related to achieving goals, self-improving, and saving money, and a con related to stress/coping. Compared to youth in Pre-Contemplation SOC, those in Contemplation were more likely to identify relationships as both a pro and con of using less cannabis. CONCLUSIONS MET can reveal developmentally appropriate goals, healthy values, and ambivalence about cannabis use that can be used to facilitate movement along the stages of behavior change toward reduction/cessation. PRACTICE IMPLICATIONS Brief motivational therapy can be used in primary care to gather information important in helping youth to reduce cannabis use.",2019,"Compared to youth in Pre-Contemplation SOC, those in Contemplation were more likely to identify relationships as both a pro and con of using less cannabis. ","['Engaging youth (adolescents and young adults', 'adolescent/young adults with frequent cannabis use in', 'Primary care patients 15-24\u202fyears old using cannabis ≥3 times/week enrolled']",['Motivational Enhancement Therapy (MET'],[],"[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],56.0,0.0207139,"Compared to youth in Pre-Contemplation SOC, those in Contemplation were more likely to identify relationships as both a pro and con of using less cannabis. ","[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Kells', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, United States of America. Electronic address: Meredith.kells@childrens.harvard.edu.""}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Burke', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, United States of America; Northeastern University Bouve College of Health Sciences, School of Nursing, United States of America.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, United States of America; Northeastern University Bouve College of Health Sciences, School of Nursing, United States of America.""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Jonestrask', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, United States of America.""}, {'ForeName': 'Lydia A', 'Initials': 'LA', 'LastName': 'Shrier', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, United States of America; Department of Pediatrics, Harvard Medical School, United States of America.""}]",Journal of pediatric nursing,['10.1016/j.pedn.2019.08.011'] 901,31929401,Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women.,"BACKGROUND Young women aged 15-24 years are disproportionately affected by the HIV epidemic. Two phase III trials of a vaginal ring containing 25-mg dapivirine demonstrated HIV-1 risk reduction in adult women older than 21 years but not in those aged 18-21 years. Lack of protection was correlated with low adherence. METHODS In this phase-IIa, randomized, double-blind, placebo-controlled, US, multicenter trial of the dapivirine ring in sexually active females, aged 15-17 years, participants were randomized 3:1 to a dapivirine or placebo ring to be inserted monthly for 6 months (NCT02028338). Primary safety end points included grade 2 product related adverse events and any grade 3 and higher adverse events. Adherence to ring use was assessed by plasma dapivirine concentrations, residual levels in used rings, and self-report. A plasma dapivirine concentration of >95 pg/mL was used to define short-term adherence; a residual ring level of <23.5 mg was used to define long-term adherence. Acceptability was assessed through computer-assisted self-interviews. RESULTS Ninety-six participants were enrolled across 6 US sites. The median age was 16.0 years. There were no differences in safety outcomes between treatment arms. Adherence to the dapivirine ring was demonstrated by both plasma measurements (87%) and residual drug levels in rings (95%). Forty-two percent (95% confidence interval: 32 to 52) of participants reported that they never removed the ring. Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits. CONCLUSION The dapivirine vaginal ring, a promising topical microbicide, was well tolerated and acceptable in young US adolescents.",2020,"Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits. ","['adult women older than 21 years but not in those aged 18-21 years', 'sexually active females, aged 15-17 years', 'Ninety-six participants were enrolled across 6 US sites', 'Forty-two percent', 'Adolescent Young Women', 'young US adolescents', 'Young women aged 15-24 years']","['vaginal ring containing 25-mg dapivirine', 'placebo', 'dapivirine or placebo', 'Vaginal Ring Containing Dapivirine', 'dapivirine ring']","['HIV-1 risk reduction', 'safety outcomes', 'grade 2 product related adverse events and any grade 3 and higher adverse events', 'plasma dapivirine concentrations, residual levels in used rings, and self-report', 'residual drug levels', 'Acceptability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",96.0,0.367086,"Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits. ","[{'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Bunge', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Szydlo', 'Affiliation': 'Fred Hutchinson Cancer Research Center- Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fred Hutchinson Cancer Research Center- Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA.'}, {'ForeName': 'Aditya H', 'Initials': 'AH', 'LastName': 'Gaur', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reirden', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Colorado, Denver, CO.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'The Fenway Institute, Boston, MA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Futterman', 'Affiliation': ""Department of Pediatrics, Children's Hospital at Montefiore Medical Center, The Bronx, NY.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hoesley', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Pamina M', 'Initials': 'PM', 'LastName': 'Gorbach', 'Affiliation': 'Department of Epidemiology, University of California at Los Angeles Fielding School of Public Health, Los Angeles, CA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Kapogiannis', 'Affiliation': 'Maternal and Pediatric Infectious Disease Branch, National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Squires', 'Affiliation': 'Merck Research Labs, Rahway, NJ.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002244'] 902,31877381,Association between Bone marrow lesions & synovitis and symptoms in symptomatic knee osteoarthritis.,"OBJECTIVE Bone marrow lesions (BMLs) on MRI are typically subchondral in location, however, a proportion occur at knee ligament attachments and also include a cyst-like component. Our aim was to determine whether the volume of BML subtypes and synovial tissue volume (STV) was associated with symptoms in symptomatic knee OA. METHOD Images were acquired in a sub-sample who had taken part in a randomised trial of vitamin D therapy in knee OA (UK-VIDEO). Contrast-enhanced (CE) MRI was performed annually. In those who had ≥1 follow-up and a baseline scan (N = 50), STV and BML volume was assessed. BMLs were categorised by location and by the presence/absence of a cyst-like component. WOMAC was assessed annually. We used fixed-effects panel-regression modelling to examine the association between volume and symptoms. RESULTS There was no association between knee pain and total subchondral BML volume (b = 0.3 WOMAC units, 95% CI -0.3 to 1.0) or total ligament-based BML volume (b = 1.9, 95% CI -1.6 to 5.3). The volume of subchondral BMLs with a cyst-like component was not associated with pain (b = 0.8, 95% CI -0.5 to 2.1) however, the volume of the cyst-like component itself was associated with pain (b = 51.8, 95% CI 14.2 to 89.3). STV was associated with pain (b = 2.2, 95% CI 0.6 to 3.7). CONCLUSION The volume of the cyst-like component from subchondral BMLs with a cyst-like component was associated with knee pain. BML location, however, did not influence symptoms. STV was also associated with knee symptoms.",2020,"STV was associated with pain (b = 2.2, 95% CI 0.6 to 3.7). ","['Images were acquired in a sub-sample who had taken part in a randomised trial of', 'Symptomatic Knee Osteoarthritis']","['vitamin D therapy', 'STV']","['WOMAC', 'Contrast-enhanced (CE) MRI', 'STV and BML volume', 'pain', 'volume of subchondral BMLs', 'volume of BML subtypes and synovial tissue volume (STV', 'total ligament-based BML volume', 'knee pain and total subchondral BML volume']","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}]",,0.0549919,"STV was associated with pain (b = 2.2, 95% CI 0.6 to 3.7). ","[{'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Perry', 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK. Electronic address: thomas.perry@postgrad.man.ac.uk.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Parkes', 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK. Electronic address: matthew.parkes@manchester.ac.uk.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Hodgson', 'Affiliation': 'Centre for Imaging Sciences, Institute of Population Health, University of Manchester, Manchester, UK. Electronic address: richard.hodgson@manchester.ac.uk.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; Clinical Epidemiology Research and Training Unit Boston University School of Medicine, Boston, MA, USA. Electronic address: dfelson@bu.edu.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; MRC Lifecourse Epidemiology Unit, Southampton University, Southampton, UK. Electronic address: nigel.arden@ndorms.ox.ac.uk.'}, {'ForeName': 'T W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; Department of Rheumatology, Salford Royal NHS Foundation Trust, Salford, UK. Electronic address: terence.oneill@manchester.ac.uk.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.12.002'] 903,31927162,"A randomized clinical trial of motivational interviewing plus skills training vs. Relaxation plus education and 12-Steps for substance using incarcerated youth: Effects on alcohol, marijuana and crimes of aggression.","BACKGROUND Motivational Interviewing plus Cognitive Behavior Therapy (MI/CBT) has been used to reduce adolescent substance use, but has rarely been applied in youth correctional settings. This trial compared MI/CBT against Relaxation Training plus Substance-Education/12-Steps (RT/SET) to reduce substance use and crime among incarcerated youth. METHODS Participants (N = 199) were incarcerated juveniles (64.8 % non-White, 10.1 % girls, mean age of 17.1 years). Two individual sessions of MI (or RT) were followed by 10 group sessions of CBT (or SET). Youth were randomized to condition with follow-ups at 3- and 6-months after release. Major outcomes included alcohol, marijuana and crimes involving aggression. RESULTS A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months. A significant treatment by time interaction was found for alcohol-related predatory aggression, with follow-up tests indicating fewer youth engaged in this behavior from 3 to 6 months within RT/SET, and weak evidence favoring MI/CBT over RT/SET at 3 months. General predatory aggression decreased from 3 to 6-months for both treatments. CONCLUSIONS Although weak evidence was found favoring MI/CBT with respect to alcohol-related predatory aggression, results generally support RT/SET in reducing percent heavy drinking days.",2020,"A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months.","['Participants (N\u202f=\u202f199) were incarcerated juveniles (64.8 % non-White, 10.1 % girls, mean age of 17.1 years']","['MI (or RT', 'Motivational Interviewing plus Cognitive Behavior Therapy (MI/CBT', 'motivational interviewing plus skills training vs. Relaxation plus education and 12-Steps for substance using incarcerated youth', 'MI/CBT against Relaxation Training plus Substance-Education/12-Steps (RT/SET']","['alcohol, marijuana and crimes involving aggression', 'General predatory aggression']","[{'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C3146221', 'cui_str': 'Juvenile (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.0213278,"A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months.","[{'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Department of Psychology, The University of Rhode Island, 130 Flagg Road, Kingston, RI 02881, United States; Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States; Department of Behavioral & Social Sciences, Brown University, Box G-S121-4, 121 South Main Street, Providence, RI 02912, United States; Rhode Island Training School, 300 New London Avenue, Cranston, RI 02920, United States. Electronic address: larstein@uri.edu.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Clair-Michaud', 'Affiliation': 'Rhode Island Training School, 300 New London Avenue, Cranston, RI 02920, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lebeau', 'Affiliation': 'Rhode Island Executive Office of Health & Human Services, 3 West Road, Cranston, RI 02920, United States.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Hurlbut', 'Affiliation': 'Administration of Justice, Salve Regina University, 100 Ochre Street, Newport, RI 02840, United States.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States; Department of Behavioral & Social Sciences, Brown University, Box G-S121-4, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Damaris', 'Initials': 'D', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107774'] 904,30920684,Examination of Treatment Effects on Hazardous Drinking Among Service Members With Posttraumatic Stress Disorder.,"Posttraumatic stress disorder (PTSD) and alcohol use disorder are frequently comorbid and present significant treatment challenges. Unfortunately, since the September 11, 2001, terrorist attacks in the United States, the rates of PTSD and hazardous drinking among active duty service members have increased significantly. Previous research on PTSD has typically excluded participants with current substance abuse. However, there is some research examining independent treatments for PTSD and substance abuse provided consecutively, concurrently, or as enhancements to other treatment. The current study examined the association between current hazardous drinking and PTSD treatment among 108 active duty service members with PTSD in a randomized controlled trial of group cognitive processing therapy and group present-centered therapy. Total scores above 8 on the Alcohol Use Disorders Identification Test defined hazardous alcohol use. At baseline, 25.0% of the sample was categorized as hazardous drinkers, and the hazardous and nonhazardous drinking groups did not differ in PTSD symptom severity, F(1, 106) = 0.08, p = .777, d = 0.06. Over the course of treatment, the two groups also did not differ significantly in PTSD symptom severity change on the PTSD Checklist, F(1, 106) = 1.20, p = .280, d = 0.33. Treatment for PTSD did not exacerbate hazardous drinking, and the hazardous drinking group showed significant reductions in drinking following PTSD treatment. Limitations and implications for treatment considerations are discussed.",2019,"Over the course of treatment, the two groups also did not differ significantly in PTSD symptom severity change on the PTSD Checklist, F(1, 106) =","['108 active duty service members with PTSD', 'participants with current substance abuse', 'Service Members With Posttraumatic Stress Disorder']",['cognitive processing therapy and group present-centered therapy'],"['Hazardous Drinking', 'PTSD symptom severity change', 'Total scores', 'rates of PTSD and hazardous drinking']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0081897,"Over the course of treatment, the two groups also did not differ significantly in PTSD symptom severity change on the PTSD Checklist, F(1, 106) =","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Jennifer Schuster', 'Initials': 'JS', 'LastName': 'Wachen', 'Affiliation': 'National Center for PTSD, VA Boston Healthcare System, Boston, Massachusetts, USA.'}, {'ForeName': 'Willie J', 'Initials': 'WJ', 'LastName': 'Hale', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Carson', 'Affiliation': 'Spinal Cord Injury Program, The Institute for Rehabilitation and Research, Memorial Hermann Hospital, Houston, Texas, USA.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'National Center for PTSD, VA Boston Healthcare System, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Department of Behavioral Health, Carl R. Darnall Army Medical Center, Fort Hood, Texas, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of traumatic stress,['10.1002/jts.22393'] 905,31923551,Effects of adjunctive inflammatory modulation on IL-1β in treatment resistant bipolar depression.,"BACKGROUND Adjunctive inflammatory modulation improved remission rates in treatment-resistant bipolar depression (TRBDD), but reliable biomarkers must be established to characterize the biosignature of TRBDD and the mechanisms underlying treatment response. In this molecular profiling study, we describe TRBDD and treatment response from the standpoint of interleukin-1 Beta (IL-1β) and KYN/TRP. METHODS 47 TRBDD patients with moderately severe HAMD-17 scores were randomized to receive either escitalopram (ESC) (10 mg-40 mg daily dose range) + celecoxib (CBX) (200 mg twice daily), or ESC (10 mg-40 mg daily dose range) + placebo (PBO) (twice daily). Plasma cytokine levels were measured in both treatment arms at baseline and week 8, and in a healthy control (HC) group of subjects (N = 43) once. A linear mixed model (LMM) was applied to evaluate whether clinical outcome is related to CBX and changes to biomarkers throughout treatment. A binary logistic regression model was formulated from this series to predict both the primary outcome of treatment response to CBX, and the secondary outcome of diagnosis of TRBDD using age, BMI, gender, and IL-1β at baseline. RESULTS Patients receiving ESC + CBX had 4.278 greater odds of responding (p = 0.021) with NNT = 3, and 15.300 times more likely to remit (p < 0.001) with NNT = 2, compared with ESC + PBO patients. Patient BMI (p = 0.003), baseline IL-1β (p = 0.004), and baseline KYN/TRP (p = 0.001) were most predictive of TRBDD diagnosis. By Week 8, responders showed a downtrend in IL-1β compared to non-responders in the ESC + CBX treatment arm. However, there was no statistical difference in the IL-1β or KYN/TRP change after treatment between placebo and ESC + CBX group responders/non-responders (p = 0.239, and p = 0.146, respectively). While baseline IL-1β was elevated in TRBDD compared to HC (p < 0.001), there was no difference in IL-1β between treatment responders at Week 8 compared to HC (p = 0.067). CONCLUSIONS Elevated IL-1β and low KYN/TRP at baseline are components of the TRBDD molecular signature. CBX but not baseline IL-1β or KYN/TRP predict treatment response. Change in IL-1β and KYN/TRP did not predict treatment response.",2020,"RESULTS Patients receiving ESC + CBX had 4.278 greater odds of responding (p=0.021) with NNT=3, and 15.300 times more likely to remit (p<0.001) with NNT=2, compared with ESC + PBO patients.",['47 TRBDD patients with moderately severe HAMD-17 scores'],"['ESC + CBX', 'ESC+CBX', 'escitalopram (ESC) (10mg - 40mg daily dose range) + celecoxib (CBX', 'placebo', 'Adjunctive Inflammatory Modulation', 'interleukin-1 Beta (IL-1β) and KYN/TRP', 'ESC (10mg - 40mg daily dose range) + placebo (PBO', 'CBX']","['remission rates', 'Plasma cytokine levels', 'Patient BMI', 'IL-1β', 'Elevated IL-1β and low KYN/TRP', 'Change in IL-1β and KYN/TRP', 'IL-1β or KYN/TRP change', 'baseline IL-1β']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.148927,"RESULTS Patients receiving ESC + CBX had 4.278 greater odds of responding (p=0.021) with NNT=3, and 15.300 times more likely to remit (p<0.001) with NNT=2, compared with ESC + PBO patients.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'Department of Orthopaedic Surgery, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoppensteadt', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Welborn', 'Affiliation': 'Department of Public Health Sciences, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Halaris', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA. Electronic address: ahalaris@lumc.edu.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.01.004'] 906,31944371,Adapted Dialectical Behavior Therapy for Adolescents with a High Risk of Suicide in a Community Clinic: A Pragmatic Randomized Controlled Trial.,"OBJECTIVE This study is a pragmatic randomized controlled trial, which compares the effectiveness of an adapted form of Dialectical Behavior Therapy for Adolescents (DBT-A) and treatment as usual plus group sessions (TAU + GS) to reduce suicidal risk for adolescents in a community health mental clinic. METHOD Thirty-five adolescents from a community outpatient clinic, with repetitive NSSI alone or with SA over the last 12 months and with current high suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), were enrolled. Participants were randomly assigned to undergo either DBT-A (n = 18) or TAU + GT (n = 17) treatments over a 16-week period. Primary outcomes were the difference between NSSI and SA recorded during the first 4 weeks and the final 4 weeks of treatment. Secondary outcomes included changes in Children's Global Assessment Scale (C-GAS), Suicidal Ideation Questionnaire (SIQ-JR), and Beck Depression Inventory-II (BDI-II). RESULTS Dialectical Behavior Therapy for Adolescents was more effective than TAU + GS at reducing NSSI, use of antipsychotics, and improving C-GAS. No SAs were reported in the two groups at the end of the treatment. Both treatments were equally effective in decreasing SIQ-JR and BDI-II scores. CONCLUSIONS These findings support the feasibility and effectiveness of DBT-A for adolescents at high risk of suicide in community settings.",2020,"RESULTS Dialectical Behavior Therapy for Adolescents was more effective than TAU + GS at reducing NSSI, use of antipsychotics, and improving C-GAS.","['adolescents in a community health mental clinic', 'Adolescents (DBT-A', 'adolescents at high risk of suicide in community settings', 'Thirty-five adolescents from a community outpatient clinic, with repetitive NSSI alone or with SA over the last 12\xa0months and with current high suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), were enrolled', 'Adolescents with a High Risk of Suicide in a Community Clinic']","['Dialectical Behavior Therapy', 'usual plus group sessions (TAU\xa0+\xa0GS', 'DBT-A (n\xa0=\xa018) or TAU\xa0+\xa0GT']","[""changes in Children's Global Assessment Scale (C-GAS), Suicidal Ideation Questionnaire (SIQ-JR), and Beck Depression Inventory-II (BDI-II"", 'NSSI and SA', 'SIQ-JR and BDI-II scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1271074', 'cui_str': 'High suicide risk'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3472495', 'cui_str': ""Children's global assessment scale""}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",35.0,0.0947995,"RESULTS Dialectical Behavior Therapy for Adolescents was more effective than TAU + GS at reducing NSSI, use of antipsychotics, and improving C-GAS.","[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Santamarina-Perez', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Mendez', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, Stanford University, Stanford, California.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, Stanford University, Stanford, California.'}, {'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Picado', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Font', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Moreno', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Morer', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Borràs', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Cosi', 'Affiliation': 'Department of Psychology, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12612'] 907,30057015,"The effects of probiotic and selenium co-supplementation on mental health parameters and metabolic profiles in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND AND AIMS The objective of this investigation was to assess the effects of probiotic and selenium co-supplementation on indicators of mental health and metabolic profiles in diabetic people with coronary heart disease (CHD). METHODS This randomized, double-blind, placebo-controlled trial was conducted among 54 diabetic people with CHD. Patients were randomly allocated into two groups to receive either 200 μg/day selenium plus 8 × 10 9  CFU/day probiotic (n = 27) or placebo (n = 27) for 12 weeks. RESULTS Probiotic and selenium co-supplementation significantly decreased Beck Depression Inventory index (β -1.46; 95% CI, -2.61, -0.31; P = 0.01) and Beck Anxiety Inventory index (β -1.23; 95% CI, -2.33, -0.12; P = 0.02) compared with the placebo. Consuming probiotic plus selenium lowered fasting plasma glucose (β -10.80 mg/dL; 95% CI, -17.68, -3.92; P = 0.003), serum insulin levels (β -3.42 μIU/mL; 95% CI, -4.93, -1.90; P < 0.001), insulin resistance (β -0.96; 95% CI, -1.45, -0.47; P < 0.001), and enhanced insulin sensitivity (β 0.01; 95% CI, 0.007, 0.01; P < 0.001) compared with the placebo. Additionally, co-supplementation reduced triglycerides (β -34.45 mg/dL; 95% CI, -56.18, -12.72; P = 0.003), VLDL- (β -6.89 mg/dL; 95% CI, -11.23, -2.54; P = 0.003), total cholesterol (β -18.13 mg/dL; 95% CI, -23.42, -2.83; P = 0.02) and high sensitivity C-reactive protein (β -1043.28 ng/mL; 95% CI, -1929.67, -156.89; P = 0.02), and increased nitric oxide (β 7.86 μmol/L; 95% CI, 5.63, 10.09; P < 0.001), total antioxidant capacity (β 119.30 mmol/L; 95% CI, 63.04, 175.57; P < 0.001) and total glutathione (β 154.16 μmol/L; 95% CI, 82.57, 225.74; P < 0.001) compared with the placebo. CONCLUSIONS Probiotic and selenium co-supplementation to diabetic people with CHD improved indicators of mental health and metabolic profiles. Registered under Clinical Trials.gov Identifier no. http://www.irct.ir: IRCT20170513033941N28.",2019,Consuming probiotic plus selenium lowered fasting plasma glucose (β -10.80 ,"['diabetic people with coronary heart disease (CHD', '54 diabetic people with CHD', 'http://www.irct.ir', 'type 2 diabetic patients with coronary heart disease']","['placebo', 'Probiotic and selenium co-supplementation', '200\xa0μg/day selenium plus 8\xa0×', 'dL', 'Consuming probiotic plus selenium', 'probiotic and selenium co-supplementation']","['triglycerides', 'total glutathione', 'mental health parameters and metabolic profiles', 'serum insulin levels', 'Beck Depression Inventory index', 'insulin resistance', 'total cholesterol', 'mental health and metabolic profiles', 'Beck Anxiety Inventory index', 'nitric oxide ', 'enhanced insulin sensitivity', 'VLDL', 'high sensitivity C-reactive protein', 'total antioxidant capacity', 'fasting plasma glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",,0.815232,Consuming probiotic plus selenium lowered fasting plasma glucose (β -10.80 ,"[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Raygan', 'Affiliation': 'Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran. Electronic address: asemi_r@yahoo.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.07.017'] 908,30420161,Effects of Trypanocidal Treatment on Echocardiographic Parameters in Chagas Cardiomyopathy and Prognostic Value of Wall Motion Score Index: A BENEFIT Trial Echocardiographic Substudy.,"BACKGROUND Serial echocardiographic studies in chronic Chagas cardiomyopathy are scarce. The aims of this study were to evaluate whether therapy with benznidazole modifies the progression of cardiac impairment and to identify baseline echocardiographic parameters related to prognosis. METHODS A prospective substudy was conducted in 1,508 patients with chronic Chagas cardiomyopathy randomized to benznidazole or placebo, who underwent two-dimensional echocardiography at enrollment, 2 years, and final follow-up (5.4 years). Left ventricular (LV) ejection fraction, LV wall motion score index (WMSI), indexed left atrial volume, and chamber dimensions were collected and correlated to all-cause death and a composite hard outcome using univariate and multivariate analyses. RESULTS At enrollment, most patients had normal chamber dimensions, and 70.5% had preserved LV ejection fractions. During follow-up, all chamber dimensions increased similarly in both treatment arms. LV ejection fraction was comparably reduced (55.7 ± 12.7% to 52.1 ± 14.6% vs 56.3 ± 12.7% to 52.8 ± 14.1%) and LV WMSI similarly increased (1.31 ± 0.41 to 1.49 ± 0.03 and 1.27 ± 0.38 to 1.51 ± 0.03) for the benznidazole and placebo groups, respectively (P > .05). A higher baseline LV WMSI was identified in subjects who died compared with those alive at final echocardiography (1.76 ± 0.517 vs 1.271 ± 0.393, P < .0001). There was a significant (P < .0001) graded increase in the risk for the composite outcome with worsening LV WMSI (hazard ratios, 2.27 [95% CI, 1.69-3.06] and 6.42 [95% CI, 4.94-8.33]) and also of death (hazard ratios, 2.45 [95% CI, 1.62-3.71] and 8.99 [95% CI, 6.3-12.82]) for 1 < LV WMSI < 1.5 and LV WMSI > 1.5, respectively. Both LV WMSI and indexed left atrial volume remained independent predictors in multivariate analysis. CONCLUSIONS Trypanocidal treatment had no effect on echocardiographic progression of chronic Chagas cardiomyopathy over 5.4 years. Despite normal global LV systolic function, regional wall motion abnormalities and indexed left atrial volume identified patients at higher risk for hard adverse clinical outcomes.",2019,"graded increase in the risk for the composite outcome with worsening LV WMSI (hazard ratios, 2.27","[' who underwent two-dimensional echocardiography at enrollment, 2\xa0years, and final follow-up (5.4\xa0years', '1,508 patients with chronic Chagas cardiomyopathy randomized to']","['benznidazole', 'benznidazole or placebo', 'Trypanocidal Treatment']","['Echocardiographic Parameters in Chagas Cardiomyopathy and Prognostic Value of Wall Motion Score Index', 'death', 'baseline LV WMSI', 'Left ventricular (LV) ejection fraction, LV wall motion score index (WMSI), indexed left atrial volume, and chamber dimensions', 'Despite normal global LV systolic function, regional wall motion abnormalities and indexed left atrial volume', 'echocardiographic progression of chronic Chagas cardiomyopathy', 'LV ejection fractions', 'LV WMSI and indexed left atrial volume', 'LV WMSI', 'normal chamber dimensions', 'LV ejection fraction']","[{'cui': 'C0013524', 'cui_str': 'Echocardiography, 2-D'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0007930', 'cui_str': 'Trypanosomiasis, Cardiovascular'}]","[{'cui': 'C0053230', 'cui_str': 'benznidazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007930', 'cui_str': 'Trypanosomiasis, Cardiovascular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0455816', 'cui_str': 'Left ventricular wall motion (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",1508.0,0.127112,"graded increase in the risk for the composite outcome with worsening LV WMSI (hazard ratios, 2.27","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Cardiology Division, Internal Medicine Department, Medical School of Ribeirão Preto, Ribeirão Preto, Brazil. Electronic address: aschmidt@fmrp.usp.br.'}, {'ForeName': 'Minna Moreira', 'Initials': 'MM', 'LastName': 'Dias Romano', 'Affiliation': 'Cardiology Division, Internal Medicine Department, Medical School of Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'José Antônio', 'Initials': 'JA', 'LastName': 'Marin-Neto', 'Affiliation': 'Cardiology Division, Internal Medicine Department, Medical School of Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Rassi', 'Affiliation': 'Hospital do Coração Anis Rassi, Goiânia, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Mattos', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Villena', 'Affiliation': 'Hospital Eduardo Eguia, Programa Chagas, Tupiza, Bolivia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sosa-Estani', 'Affiliation': 'Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben-Administración Nacional de Laboratórios e Institutos de Salud, CONICET, Instituto de Efectividad Clinica y Sanitaria, Buenos Aires, Argentina.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Bonilla', 'Affiliation': 'Hospital Nacional Rosales, San Salvador, El Salvador.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Benedito Carlos', 'Initials': 'BC', 'LastName': 'Maciel', 'Affiliation': 'Cardiology Division, Internal Medicine Department, Medical School of Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2018.09.006'] 909,31913324,Impact of an integrated mother-preterm infant intervention on birth hospitalization charges.,"OBJECTIVE To examine whether the H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) intervention reduced birth hospitalization charges yielding net savings after adjusting for intervention costs. STUDY DESIGN One hundred and twenty-one mother-preterm infant dyads randomized to H-HOPE or a control group had birth hospitalization data. Neonatal intensive care unit costs were based on billing charges. Linear regression, propensity scoring and regression analyses were used to describe charge differences. RESULTS Mean H-HOPE charges were $10,185 lower than controls (p = 0.012). Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants. Cost savings increased as hospital charges increased. The mean intervention cost was $680 per infant. CONCLUSIONS Lower birth hospitalization charges and the net cost savings of H-HOPE infants support implementation of H-HOPE as the standard of care for preterm infants.",2020,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[""Preterm Infant's Environment"", 'One hundred and twenty-one mother-preterm infant dyads randomized to', 'preterm infants']","['H-HOPE', 'H-HOPE (Hospital to Home', 'integrated mother-preterm infant intervention']","['birth hospitalization data', 'mean intervention cost', 'Mean H-HOPE charges', 'birth hospitalization charges', 'Cost savings']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",121.0,0.0351533,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[{'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Vonderheid', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA. vonde@uic.edu.'}, {'ForeName': 'Chang G', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rankin', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'White-Traut', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0567-7'] 910,31680410,Assessment of changes in biophysical parameters by dermocosmetic emulgel loaded with Cinnamomum tamala extract: A split-faced and placebo-controlled study.,"BACKGROUND Phenolic and flavonoid compounds found in plants alleviate the photo-damaging skin conditions by playing a major role in skin rejuvenation. AIMS The aim of the study was to explore the cosmeceutical effects of Cinnamomum tamala extract. OBJECTIVE Recent research was aimed to quantify phenols and flavonoids in the natural extract of C tamala leaves, to develop its phyto-cosmetic emulgel and to assess effects of emulgel on healthy human skin. METHOD Phenols and flavonoids in C tamala (CT) extract were quantified by using ELISA assay. Emulgel formulation loaded with 4% C tamala (CT emulgel) was developed, and its cosmetic effects were evaluated on the cheeks of 13 healthy female test volunteers by comparing with placebo (base). Facial parameters including melanin, erythema, sebum, and visible facial pores (size and area) were studied by using Mexameter ® , Sebumeter ® , and VisioFace ® at regular interval for 90 days. RESULTS Total phenolic content and total flavonoids content of C tamala leaves extract were found to be 73.08 ± 0.0078 mg GAE/g and 52.63 ± 0.0060 mg QE/g CT extract respectively. As compared to placebo (base), CT emulgel was found to be significantly (P ≤ .05) effective in minimizing skin photo-damaging effects by reducing the levels of melanin, erythema, and sebum and size and count of both fine and large facial pores. CONCLUSION Cinnamomum tamala leaves extract, being a rich source of phenols and flavonoids minimized the photo-damaging effects by reducing skin melanin, erythema, and excess sebum; improving the skin imperfections by reducing facial pore count and area as assessed by advanced imaging and bioengineering techniques.",2020,"As compared to placebo (base), CT emulgel was found to be significantly (P ≤ .05) effective in minimizing skin photo-damaging effects by reducing the levels of melanin, erythema, and sebum and size and count of both fine and large facial pores. ","['healthy human skin', '13 healthy female test volunteers by comparing with']","['placebo', 'Cinnamomum tamala extract', 'Emulgel formulation loaded with 4% C\xa0tamala (CT emulgel']","['Facial parameters including melanin, erythema, sebum, and visible facial pores (size and area', 'levels of melanin, erythema, and sebum and size and count of both fine and large facial pores']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0969704', 'cui_str': 'Cinnamomum'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",,0.0264018,"As compared to placebo (base), CT emulgel was found to be significantly (P ≤ .05) effective in minimizing skin photo-damaging effects by reducing the levels of melanin, erythema, and sebum and size and count of both fine and large facial pores. ","[{'ForeName': 'Wajeeha', 'Initials': 'W', 'LastName': 'Arshad', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}, {'ForeName': 'Haji Muhammad Shoaib', 'Initials': 'HMS', 'LastName': 'Khan', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Akhtar', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}, {'ForeName': 'Mehwish', 'Initials': 'M', 'LastName': 'Nawaz', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13198'] 911,31908178,The impact of posterior epidural adipose tissue on postoperative outcomes after posterior decompression surgery for lumbar spinal stenosis: A prospectively randomized non-inferiority trial.,"STUDY DESIGN The present study is a prospectively randomized study. OBJECTIVE The objective of the study was to evaluate the impact of posterior epidural adipose tissue (PAT) on postoperative outcome following lumbar decompression surgery for lumbar spinal stenosis (LSS) by whether PAT was removed or preserved during the surgical procedure. SUMMARY OF BACKGROUND DATA In posterior decompression surgery for LSS, PAT is routinely removed without knowledge of its role and significance. However, considering adipose tissue has regenerative properties of damaged neighboring tissues or itself, PAT, which is adipose tissue located at peridural space, might also have a potential to regenerate the neighboring damaged tissue, including dura and nerve root in the lumbar spine, but this has not been thoroughly studied. METHODS Of the 185 eligible patients screened for the current study, 181 patients were enrolled and randomly allocated into either group A (PAT removal, n = 90) or group B (PAT retention, n = 91). The primary outcome measure was pain intensity on the lower back and lower extremity. The secondary outcome measures were functional outcome based on the Oswestry disability index (ODI) and walking distance, complications during the surgical procedure, and surgical outcomes. RESULTS Postoperative pain intensity on the lower back and lower extremity was greater in group A than in group B. Functional status on ODI and walking distance was also worse in group B than in group A (64.9% in group A and 66.2% in group B). The number of patients with aggravated pain intensity and deteriorated functional status in postoperative follow-up times was significantly greater in group A than in group B. There were no significant differences in surgical outcome and complications between the groups. CONCLUSION Preserving epidural fat may be favorable in postoperative outcomes of posterior decompression surgery for LSS compared to removing epidural fat.",2020,The number of patients with aggravated pain intensity and deteriorated functional status in postoperative follow-up times was significantly greater in group A than in group,"['Of the 185 eligible patients screened for the current study, 181 patients', 'lumbar spinal stenosis (LSS', 'lumbar spinal stenosis']","['group A (PAT removal, n = 90) or group B (PAT retention', 'posterior epidural adipose tissue', 'posterior epidural adipose tissue (PAT', 'posterior decompression surgery', 'lumbar decompression surgery']","['functional outcome based on the Oswestry disability index (ODI) and walking distance, complications during the surgical procedure, and surgical outcomes', 'number of patients with aggravated pain intensity and deteriorated functional status', 'surgical outcome and complications', 'postoperative outcomes', 'lower back and lower extremity', 'ODI and walking distance', 'pain intensity on the lower back and lower extremity']","[{'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444749', 'cui_str': 'Exacerbated (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}]",181.0,0.0536714,The number of patients with aggravated pain intensity and deteriorated functional status in postoperative follow-up times was significantly greater in group A than in group,"[{'ForeName': 'Gun Woo', 'Initials': 'GW', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Spine Center, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Jong-Uk', 'Initials': 'JU', 'LastName': 'Mun', 'Affiliation': 'Department of Orthopaedic Surgery, Spine Center, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Myun-Whan', 'Initials': 'MW', 'LastName': 'Ahn', 'Affiliation': 'Department of Orthopaedic Surgery, Spine Center, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019896871'] 912,31466895,VR Simulation Leads to Enhanced Procedural Confidence for Surgical Trainees.,"OBJECTIVE Active learning techniques result in greater knowledge acquisition compared to passive methods. For medical students with limited hands-on operative experiences, virtual reality platforms represent active learning and may enhance procedural training. We hypothesize that virtual reality simulators like Toolkit for Illustration of Procedures in Surgery (TIPS) are a more effective modality in teaching laparoscopic surgical techniques to medical students when compared to passive learning tools like videos. DESIGN In this crossover study, participants were randomly assigned to perform either a TIPS laparoscopic appendectomy followed by video of a laparoscopic cholecystectomy, or video of a laparoscopic appendectomy followed by TIPS laparoscopic cholecystectomy. A knowledge assessment followed each intervention. A postsurvey was used to gather feedback and subjective impressions of the learning experience. SETTING University of Central Florida College of Medicine. PARTICIPANTS Second, third, and fourth-year medical students (n = 37). RESULTS Validation of the content assessments revealed strong internal consistency (Cronbach's α = 0.73). A 2-tailed Fisher's exact test revealed that the video had greater ease of use (p = 0.032), but TIPS had greater utility as a learning tool (p < 0.001) and instilled greater confidence in the ability to reproduce procedural steps (p < 0.001). A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS both enhanced different aspects of student learning; however, the active TIPS platform produced greater confidence in the ability to reproduce the steps of the procedure and had greater utility as a learning strategy. Videos are simple to use and can serve a complementary role in curriculum design.",2020,"A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS","['Second, third, and fourth-year medical students (n = 37', 'University of Central Florida College of Medicine']","['TIPS laparoscopic appendectomy followed by video of a laparoscopic cholecystectomy, or video of a laparoscopic appendectomy followed by TIPS laparoscopic cholecystectomy', 'Video and TIPS']",[],"[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0339897', 'cui_str': 'TIPSS'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.0281266,"A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lesch', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'University of Florida College of Engineering, Gainesville, Florida.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Cendán', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida. Electronic address: juan.cendan@ucf.edu.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.08.008'] 913,31808151,Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index.,"Sugammadex, a specific reversal agent for steroidal neuromuscular blocking drugs, has on occasion been reported to be associated with clinical signs of awakening. We performed a study to systematically search for an increase in bispectral index values and signs of awakening in patients maintained under general anaesthesia following sugammadex administration. Patients, scheduled to receive general anaesthesia with neuromuscular blockade, were included in this double-blind randomised crossover study. After surgery was completed, and while the train-of-four ratio was zero, intravenous anaesthesia was continued with the aim of maintaining the bispectral index in the range of 40-60. Patients then received either sugammadex 4 mg.kg -1 or saline. In cases of incomplete reversal of neuromuscular blockade after 5 min, patients received the other drug. Bispectral index and train-of-four monitoring were recorded every minute and clinical signs of awakening noted. Fifty-one patients completed the study. Median (IQR [range]) bispectral index values increased after sugammadex administration from 49 (43-53 [38-64]) to 63 (53-80 [45-97]) (p < 0.01) with an increase of ≥ 20 in 22 patients; 14 (27%) patients had clinical signs of awakening. Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade. This study confirms that reversal of neuromuscular blockade with sugammadex may be associated with clinical signs of awakening despite maintenance of anaesthesia. Intravenous anaesthesia should be maintained until complete recovery of muscle function is achieved, especially when sugammadex is administered.",2020,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","['Fifty-one patients completed the study', 'patients maintained under general anaesthesia following sugammadex administration', 'Patients, scheduled to receive general anaesthesia with neuromuscular blockade']","['sugammadex', 'sugammadex 4\xa0mg.kg -1 or saline', 'anaesthetic agents', 'Sugammadex', 'Saline']","['bispectral index values', 'clinical signs of awakening', 'Median (IQR [range', 'bispectral index values and signs of awakening', 'bispectral index values, clinical signs of awakening or degree of neuromuscular blockade', 'Bispectral index and train-of-four monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C1301770', 'cui_str': 'Train-of-Four Monitoring'}]",51.0,0.555859,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roussel', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chazot', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Dumont', 'Affiliation': 'Department of Electrical and Computer Engineering, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}]",Anaesthesia,['10.1111/anae.14897'] 914,31666284,Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial.,"BACKGROUND First-degree relatives (FDR) of patients with colorectal cancer are at risk for colorectal cancer, but may not be up to date with colorectal cancer screening. We sought to determine whether a one-time recommendation about needing colorectal cancer screening using patient navigation (PN) was better than just receiving the recommendation only. METHODS Participants were FDRs of patients with Lynch syndrome-negative colorectal cancer from participating Ohio hospitals. FDRs from 259 families were randomized to a website intervention (528 individuals), which included a survey and personal colorectal cancer screening recommendation, while those from 254 families were randomized to the website plus telephonic PN intervention (515 individuals). Primary outcome was adherence to the personal screening recommendation (to get screened or not to get screened) received from the website. Secondary outcomes examined who benefited from adding PN. RESULTS At the end of the 14-month follow-up, 78.6% of participants were adherent to their recommendation for colorectal cancer screening with adherence similar between arms ( P = 0.14). Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared with the website intervention (OR: 2.98; 95% confidence interval, 1.68-5.28). CONCLUSIONS Addition of PN to a website intervention did not improve adherence to a colorectal cancer screening recommendation overall; however, the addition of PN was more effective in increasing adherence among FDRs who needed screening immediately. IMPACT These findings provide important information as to when the additional costs of PN are needed to assure colorectal cancer screening among those at high risk for colorectal cancer.",2020,"Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared to the website intervention (OR: 2.98, 95% CI: (1.68, 5.28). ","['528 individuals), which included a survey and personal CRC screening recommendation, while those from 254 families', 'for those at Increased Risk Based on Family History', '259 families', 'First degree relatives (FDRs) of colorectal cancer (CRC) patients', 'Participants were FDRs of Lynch syndrome negative CRC patients from participating Ohio hospitals']","['Two Interventions to Increase Colorectal Cancer Screening', 'website plus telephonic PN intervention', 'CRC screening using patient navigation (PN', 'website intervention']","['adherence to the personal screening recommendation (to get screened or not to get screened', 'odds of receiving screening']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552100', 'cui_str': 'Lynch Syndrome'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",528.0,0.0678806,"Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared to the website intervention (OR: 2.98, 95% CI: (1.68, 5.28). ","[{'ForeName': 'Electra D', 'Initials': 'ED', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio. electra.paskett@osumc.edu.'}, {'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Bernardo', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Young', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Mira L', 'Initials': 'ML', 'LastName': 'Katz', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Reiter', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Cathy M', 'Initials': 'CM', 'LastName': 'Tatum', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Oliveri', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Cecilia R', 'Initials': 'CR', 'LastName': 'DeGraffinreid', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Darrell Mason', 'Initials': 'DM', 'LastName': 'Gray', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pearlman', 'Affiliation': 'Division of Human Genetics, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hampel', 'Affiliation': 'Division of Human Genetics, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0797'] 915,31924539,Effect of a differentiated service delivery model on virological failure in adolescents with HIV in Zimbabwe (Zvandiri): a cluster-randomised controlled trial.,"BACKGROUND Adolescents living with HIV face challenges to their wellbeing and antiretroviral therapy adherence and have poor treatment outcomes. We aimed to evaluate a peer-led differentiated service delivery intervention on HIV clinical and psychosocial outcomes among adolescents with HIV in Zimbabwe. METHODS 16 public primary care facilities (clusters) in two rural districts in Zimbabwe (Bindura and Shamva) were randomly assigned (1:1) to provide enhanced HIV care support (the Zvandiri intervention group) or standard HIV care (the control group) to adolescents (aged 13-19 years) with HIV. Eligible clinics had at least 20 adolescents in pre-ART or ART registers and were geographically separated by at least 10 km to minimise contamination. Adolescents were eligible for inclusion if they were living with HIV, registered for HIV care at one of the trial clinics, and either starting or already on ART. Exclusion criteria were being too physically unwell to attend clinic (bedridden), psychotic, or unable to give informed assent or consent. Adolescents with HIV at all clinics received adherence support through adult counsellors. At intervention clinics, adolescents with HIV were assigned a community adolescent treatment supporter, attended a monthly support group, and received text messages, calls, home visits, and clinic-based counselling. Implementation intensity was differentiated according to each adolescent's HIV vulnerability, which was reassessed every 3 months. Caregivers were invited to a support group. The primary outcome was the proportion of adolescents who had died or had a viral load of at least 1000 copies per μL after 96 weeks. In-depth qualitative data were collected and analysed thematically. The trial is registered with Pan African Clinical Trial Registry, number PACTR201609001767322. FINDINGS Between Aug 15, 2016, and March 31, 2017, 500 adolescents with HIV were enrolled, of whom four were excluded after group assignment owing to testing HIV negative. Of the remaining 496 adolescents, 212 were recruited at Zvandiri intervention sites and 284 at control sites. At enrolment, the median age was 15 years (IQR 14-17), 52% of adolescents were female, 81% were orphans, and 47% had a viral load of at least 1000 copies per μL. 479 (97%) had primary outcome data at endline, including 28 who died. At 96 weeks, 52 (25%) of 209 adolescents in the Zvandiri intervention group and 97 (36%) of 270 adolescents in the control group had an HIV viral load of at least 1000 copies per μL or had died (adjusted prevalence ratio 0·58, 95% CI 0·36-0·94; p=0·03). Qualitative data suggested that the multiple intervention components acted synergistically to improve the relational context in which adolescents with HIV live, supporting their improved adherence. No adverse events were judged to be related to study procedures. Severe adverse events were 28 deaths (17 in the Zvandiri intervention group, 11 in the control group) and 57 admissions to hospital (20 in the Zvandiri intervention group, 37 in the control group). INTERPRETATION Peer-supported community-based differentiated service delivery can substantially improve HIV virological suppression in adolescents with HIV and should be scaled up to reduce their high rates of morbidity and mortality. FUNDING Positive Action for Adolescents Program, ViiV Healthcare.",2020,No adverse events were judged to be related to study procedures.,"['Adolescents were eligible for inclusion if they were living with HIV, registered for HIV care at one of the trial clinics, and either starting or already on ART', 'adolescents with HIV in Zimbabwe (Zvandiri', 'Eligible clinics had at least 20 adolescents in pre-ART or ART registers and were geographically separated by at least 10 km to minimise contamination', 'Adolescents living with HIV', 'adolescents with HIV in Zimbabwe', '16 public primary care facilities (clusters) in two rural districts in Zimbabwe (Bindura and Shamva', '500 adolescents with HIV were enrolled, of whom four were excluded after group assignment owing to testing HIV negative', 'Between Aug 15, 2016, and March 31, 2017', 'Exclusion criteria were being too physically unwell to attend clinic (bedridden), psychotic, or unable to give informed assent or consent', 'adolescents with HIV', 'the control group) to adolescents (aged 13-19 years) with HIV', 'Of the remaining 496 adolescents, 212 were recruited at Zvandiri intervention sites and 284 at control sites', 'Adolescents with HIV at all clinics received adherence support through adult counsellors']","['differentiated service delivery model', 'peer-led differentiated service delivery intervention', 'community adolescent treatment supporter, attended a monthly support group, and received text messages, calls, home visits, and clinic-based counselling', 'Zvandiri intervention', 'provide enhanced HIV care support (the Zvandiri intervention group) or standard HIV care']","['HIV virological suppression', 'viral load', 'HIV viral load', 'virological failure', 'proportion of adolescents who had died or had a viral load', 'Severe adverse events', 'adverse events', 'HIV clinical and psychosocial outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4285956', 'cui_str': 'Physically unwell'}, {'cui': 'C0730261', 'cui_str': 'Attends outpatients'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",500.0,0.208804,No adverse events were judged to be related to study procedures.,"[{'ForeName': 'Webster', 'Initials': 'W', 'LastName': 'Mavhu', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: webster.mavhu@lstmed.ac.uk.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Willis', 'Affiliation': 'Africaid, Harare, Zimbabwe.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Mufuka', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bernays', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, Australia; MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Tshuma', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe.'}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Mangenah', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Institute of Psychology, Health, and Society, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Mangezi', 'Affiliation': 'Department of Psychiatry, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Tsitsi', 'Initials': 'T', 'LastName': 'Apollo', 'Affiliation': 'AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Health Services and Population Research Department, King's College London, London, UK.""}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Cowan', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30526-1'] 916,31483187,Increased Likelihood of Pregnancy Using an App-Connected Ovulation Test System: A Randomized Controlled Trial.,"Background: Women trying to conceive are increasingly using fertility-tracking software applications to time intercourse. This study evaluated the difference in conception rates between women trying to conceive using an application-connected ovulation test system, which measures urinary luteinizing hormone and an estrogen metabolite, versus those trying without using ovulation testing. Materials and Methods: This home-based study involved 844 volunteers aged 18-40 years seeking to conceive. Volunteers randomized to the test arm were required to use the test system for the duration of the study while those randomized to the control arm were instructed not to use ovulation testing. Pregnancy rate differences across one and two cycles between the two groups were examined. Results: Volunteers in the test ( n  = 382) and control arms ( n  = 403) had similar baseline demographics. The proportion of women pregnant after one cycle was significantly greater in the test arm (25.4%) compared with the control arm (14.7%; p  < 0.001). After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%; p  = 0.026). In the test arm, volunteers had intercourse less frequently per cycle compared with those not using ovulation testing (9 [range: 1-60] vs. 10 [range: 1-50]; p  = 0.027), but were more likely to target intercourse to a particular part of their cycle compared with those not using ovulation testing (88.5% vs. 57.8%; p  < 0.001). Conclusion: Using the test system to time intercourse within the fertile window increases the likelihood of conceiving within two menstrual cycles.",2020,"After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%; p  = 0.026).","['Results: Volunteers in the test ( n \u2009=\u2009382) and control arms ( n \u2009=\u2009403) had similar baseline demographics', '844 volunteers aged 18-40 years seeking to conceive']",[],"['conception rates', 'Pregnancy rate differences']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",844.0,0.0908595,"After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%; p  = 0.026).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Stanford', 'Affiliation': 'Division of Public Health, Department of Family and Preventive Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Warren', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bench-Capon', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zinaman', 'Affiliation': 'Department of Obstetrics and Gynecology, Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7850'] 917,30318090,Reward sensitivity predicts dopaminergic response in spatial neglect.,"It has recently been revealed that spatial neglect can be modulated by motivational factors including anticipated monetary reward. A number of dopaminergic agents have been evaluated as treatments for neglect, but the results have been mixed, with no clear anatomical or cognitive predictors of dopaminergic responsiveness. Given that the effects of incentive motivation are mediated by dopaminergic pathways that are variably damaged in stroke, we tested the hypothesis that the modulatory influences of reward and dopaminergic drugs on neglect are themselves related. We employed a single-dose, double-blind, crossover design to compare the effects of Co-careldopa and placebo on a modified visual cancellation task in patients with neglect secondary to right hemisphere stroke. Whilst confirming that reward improved visual search in this group, we showed that dopaminergic stimulation only enhances visual search in the absence of reward. When patients were divided into REWARD-RESPONDERs and REWARD-NON-RESPONDERs, we found an interaction, such that only REWARD-NON-RESPONDERs showed a positive response to reward after receiving Co-careldopa, whereas REWARD-RESPONDERs were not influenced by drug. At a neuroanatomical level, responsiveness to incentive motivation was most associated with intact dorsal striatum. These findings suggest that dopaminergic modulation of neglect follows an 'inverted U' function, is dependent on integrity of the reward system, and can be measured as a behavioural response to anticipated reward.",2020,"Whilst confirming that reward improved visual search in this group, we showed that dopaminergic stimulation only enhances visual search in the absence of reward.",['patients with neglect secondary to right hemisphere stroke'],['Co-careldopa and placebo'],['visual search'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",,0.183165,"Whilst confirming that reward improved visual search in this group, we showed that dopaminergic stimulation only enhances visual search in the absence of reward.","[{'ForeName': 'Korina', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Division of Brain Sciences, Imperial College London, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bentley', 'Affiliation': 'Division of Brain Sciences, Imperial College London, Charing Cross Hospital, London, UK; Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Halse', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Barker', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Guy's Campus, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Soto', 'Affiliation': 'Basque Center on Cognition, Brain and Language, San Sebastian, Spain; Ikerbasque, Basque Foundation for Science, Bilbao, Spain.'}, {'ForeName': 'Paresh A', 'Initials': 'PA', 'LastName': 'Malhotra', 'Affiliation': 'Division of Brain Sciences, Imperial College London, Charing Cross Hospital, London, UK; Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK. Electronic address: p.malhotra@imperial.ac.uk.'}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2018.09.002'] 918,31436325,Early MRI predictors of disease-free survival in locally advanced rectal cancer from the GRECCAR 4 trial.,"BACKGROUND Tailored neoadjuvant treatment of locally advanced rectal cancer (LARC) may improve outcomes. The aim of this study was to determine early MRI prognostic parameters with which to stratify neoadjuvant treatment in patients with LARC. METHODS All patients from a prospective, phase II, multicentre randomized study (GRECCAR4; NCT01333709) were included, and underwent rectal MRI before treatment, 4 weeks after induction chemotherapy and after completion of chemoradiotherapy (CRT). Tumour volumetry, MRI tumour regression grade (mrTRG), T and N categories, circumferential resection margin (CRM) status and extramural vascular invasion identified by MRI (mrEMVI) were evaluated. RESULTS A total of 133 randomized patients were analysed. Median follow-up was 41·4 (95 per cent c.i. 36·6 to 45·2) months. Thirty-one patients (23·3 per cent) developed tumour recurrence. In univariable analysis, mrEMVI at baseline was the only prognostic factor associated with poorer outcome (P = 0·015). After induction chemotherapy, a larger tumour volume on MRI (P = 0·019), tumour volume regression of 60 per cent or less (P = 0·002), involvement of the CRM (P = 0·037), mrEMVI (P = 0·026) and a poor mrTRG (P = 0·023) were associated with poor outcome. After completion of CRT, the absence of complete response on MRI (P = 0·004), mrEMVI (P = 0·038) and a poor mrTRG (P = 0·005) were associated with shorter disease-free survival. A final multivariable model including all significant variables (baseline, after induction, after CRT) revealed that Eastern Cooperative Oncology Group performance status (P = 0·011), sphincter involvement (P = 0·009), mrEMVI at baseline (P = 0·002) and early tumour volume regression of 60 per cent or less after induction (P = 0·007) were associated with relapse. CONCLUSION Baseline and early post-treatment MRI parameters are associated with prognosis in LARC. Future preoperative treatment should stratify treatment according to baseline mrEMVI status and early tumour volume regression.",2019,"After induction chemotherapy, a larger tumour volume on MRI (P = 0·019), tumour volume regression of 60 per cent or less (P = 0·002), involvement of the CRM (P = 0·037), mrEMVI (P = 0·026) and a poor mrTRG (P = 0·023) were associated with poor outcome.","['A total of 133 randomized patients were analysed', 'patients with LARC', 'locally advanced rectal cancer', 'locally advanced rectal cancer (LARC']",['induction chemotherapy and after completion of chemoradiotherapy (CRT'],"['tumour recurrence', 'Tumour volumetry, MRI tumour regression grade (mrTRG), T and N categories, circumferential resection margin (CRM) status and extramural vascular invasion identified by MRI (mrEMVI', 'early MRI prognostic parameters', 'sphincter involvement', 'shorter disease-free survival']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0436188', 'cui_str': 'Volumetry (procedure)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",133.0,0.0702971,"After induction chemotherapy, a larger tumour volume on MRI (P = 0·019), tumour volume regression of 60 per cent or less (P = 0·002), involvement of the CRM (P = 0·037), mrEMVI (P = 0·026) and a poor mrTRG (P = 0·023) were associated with poor outcome.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nougaret', 'Affiliation': 'Department of Radiology, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': 'Biometrics Unit, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'de Forges', 'Affiliation': 'Clinical Research Unit, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Vargas', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gallix', 'Affiliation': 'Department of Radiology, Royal Victoria Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': 'Biometrics Unit, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': 'Department of Surgical Oncology, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.11233'] 919,31773810,Comparing the Netra smartphone refractor to subjective refraction.,"BACKGROUND Among technologies targeting mobile eye care, EyeNetra is a smartphone-based subjective refraction system. This study compared the results from this system with those of professional subjective refraction. Participant visual comfort and preference of results were also measured. METHODS Thirty-six optometry-naïve participants (n = 36 eyes, aged 18-35 years), were randomly subjected to three refraction methods: professional subjective refraction, unassisted Netra (participants alone) and refined Netra (sphere results refined by a practitioner). Using a randomised, double-blind design, refraction results were mounted in a trial frame and distance logMAR visual acuities were measured. Subjective appreciation and visual comfort were assessed by questionnaire. Overall preference was ranked. RESULTS Unassisted Netra yielded a median myopic overcorrection of 0.60 D (interquartile range [IQR] 0.25 to 0.94) compared to professional subjective refraction. Median equivalent sphere with unassisted Netra (-1.40 D, IQR -3.10 to -0.90) was significantly more myopic than refined Netra (-0.70 D, IQR -1.60 to -0.30) and then subjective refraction (-0.80 D, IQR -1.60 to -0.30) (all p-values < 0.01). Median visual acuity with professional subjective refraction (-0.16, IQR -0.22 to -0.09) was superior than unassisted Netra (-0.08, IQR -0.20 to 0.03) (p < 0.01). Subjective refraction was ranked first in preference of trial framed results by 72 per cent of participants; median preference rank favoured professional subjective refraction to both Netra results (all p < 0.01). For all questionnaire items, visual comfort was higher with subjective refraction than with unassisted Netra (all p < 0.04). CONCLUSION The Netra device - especially when used without professional assistance and compared to subjective refraction - induces significant myopic overcorrection and lower levels of visual acuity, subjective preference and visual comfort.",2020,"The Netra device - especially when used without professional assistance and compared to subjective refraction - induces significant myopic overcorrection and lower levels of visual acuity, subjective preference and visual comfort.","['Thirty-six optometry-naïve participants (n = 36 eyes, aged 18-35 years']","['professional subjective refraction, unassisted Netra (participants alone) and refined Netra (sphere results refined by a practitioner']","['Subjective appreciation and visual comfort', 'visual comfort', 'Median equivalent sphere with unassisted Netra', 'visual acuity, subjective preference and visual comfort', 'Median visual acuity with professional subjective refraction', 'distance logMAR visual acuities', 'Overall preference', 'Subjective refraction', 'subjective refraction', 'median myopic overcorrection', 'professional subjective refraction']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0029147', 'cui_str': 'Optometry'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1301318', 'cui_str': 'M-Manifest refraction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1301318', 'cui_str': 'M-Manifest refraction'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0561932,"The Netra device - especially when used without professional assistance and compared to subjective refraction - induces significant myopic overcorrection and lower levels of visual acuity, subjective preference and visual comfort.","[{'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Tousignant', 'Affiliation': 'School of Optometry, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Garceau', 'Affiliation': 'School of Optometry, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Bouffard-Saint-Pierre', 'Affiliation': 'School of Optometry, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Maxime', 'Initials': 'MM', 'LastName': 'Bellemare', 'Affiliation': 'School of Optometry, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Hanssens', 'Affiliation': 'School of Optometry, Université de Montréal, Montréal, QC, Canada.'}]",Clinical & experimental optometry,['10.1111/cxo.13003'] 920,31908182,Daily blood loss transition after total knee arthroplasty with topical administration of tranexamic acid: Paradoxical blood loss after action of tranexamic acid.,"PURPOSE The purpose of this study was to compare the daily blood loss transition between groups with and without topical administration of tranexamic acid (TXA) after cruciate retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA). METHODS A total of 220 patients undergoing unilateral TKA were enrolled in CR and PS TKAs, which were divided into groups that received topical administration of TXA (TXA group) or without TXA (non-TXA group). Each group in both types of TKA included 55 patients. The daily transition of blood loss was compared between the TXA and the non-TXA groups in CR and PS TKAs. The blood loss was calculated through Nadler formula using the patient's blood volume and hemoglobin reduction rate. RESULTS Total blood loss was significantly lower in the TXA group in both CR and PS TKAs ( p < 0.001, respectively). The blood loss was lower for 0-24 h and 24-48 h after TKA. However, from 48 h to 72 h, it was greater in the TXA group (253.1 vs. 34.6 mL; p < 0.001) in CR TKAs. These tendencies were similar in PS TKAs after 48 h (186.2 vs. 134.9 mL, p = 0.223). CONCLUSIONS Topical administration of TXA for reduction of blood loss seemed to be effective up to 48 h after both CR and PS TKAs. The blood loss after 48 h tended to be even greater in the TXA group. Future studies will be required to identify the pharmacokinetic evidence for this clinical finding. LEVEL OF EVIDENCE Level II.",2020,"RESULTS Total blood loss was significantly lower in the TXA group in both CR and PS TKAs ( p < 0.001, respectively).",['220 patients undergoing unilateral TKA were enrolled in CR and PS TKAs'],"['tranexamic acid (TXA', 'topical administration of TXA (TXA group) or without TXA', 'cruciate retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA', 'tranexamic acid', 'TXA']","['Total blood loss', 'daily transition of blood loss', 'Paradoxical blood loss', 'blood loss']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001566', 'cui_str': 'Drug Administration, Topical'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205310', 'cui_str': 'Paradoxical (qualifier value)'}]",220.0,0.0975924,"RESULTS Total blood loss was significantly lower in the TXA group in both CR and PS TKAs ( p < 0.001, respectively).","[{'ForeName': 'Sang Jun', 'Initials': 'SJ', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Dae Kyung', 'Initials': 'DK', 'LastName': 'Bae', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul Sacred Heart General Hospital, Seoul, Korea.'}, {'ForeName': 'Cheol Hee', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Graduate School, Kyung Hee University, Seoul, Korea.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019895816'] 921,31405799,Struggling Prior to a Teaching Event Results in Superior Short-Term Skills Acquisition in Novice Learners.,"OBJECTIVE The act of generating an answer/solution before a learning episode has been shown to enhance performance, even if the learner produces incorrect answers/solutions. This phenomenon has been termed the pretesting effect. In essence, allowing a learner to struggle prior to instruction may be beneficial. The benefits of the pretesting effect have been demonstrated with declarative knowledge (i.e., facts). The objective of this study was to investigate whether the benefits of the pretesting effect extend to acquisition of procedural skill. DESIGN Prospective, randomized, pretest-posttest experiment. PARTICIPANTS AND SETTING Forty-two first- and second-year medical students enrolled at the University of Texas Health Science Center at San Antonio completed this study. INTERVENTIONS Participants were randomly assigned to 1 of 2 instructional conditions. Participants in the teach-first (TF) condition watched a detailed instructional video of laparoscopic intracorporeal suturing and knot-tying (ICSKT) with auditory and text step-by-step instructions prior to attempting the exercise. In contrast, participants in the struggle-first (SF) condition attempted the ICSKT exercise prior to watching the instructional video. All participants completed 4 trials of ICSKT. The first trial was scored as the pretest and the final trial was the post-test. RESULTS Participants in the TF group had higher pretest scores than participants in the SF group, however these differences were not significant. Despite the pretest deficit, participants in the SF group had higher post-test scores compared to the TF group (p = 0.03). CONCLUSIONS Allowing learners to struggle with a procedural skill prior to receiving instruction results in superior acquisition of psychomotor skills.",2020,"RESULTS Participants in the TF group had higher pretest scores than participants in the SF group, however these differences were not significant.","['Forty-two first- and second-year medical students enrolled at the University of Texas Health Science Center at San Antonio completed this study', 'Participants in the teach-first (TF) condition watched a', 'Novice Learners']",['detailed instructional video of laparoscopic intracorporeal suturing and knot-tying (ICSKT) with auditory and text step-by-step instructions prior to attempting the exercise'],"['higher post-test scores', 'higher pretest scores']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0429379,"RESULTS Participants in the TF group had higher pretest scores than participants in the SF group, however these differences were not significant.","[{'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Willis', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Surgery, San Antonio, Texas. Electronic address: willisr@uthscsa.edu.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Erwin', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Surgery, San Antonio, Texas.'}, {'ForeName': 'Fayette', 'Initials': 'F', 'LastName': 'Adelaja', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Surgery, San Antonio, Texas.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.07.022'] 922,31878810,Efficacy of Recombinant Human Epidermal Growth Factor (Regen-D 150) in Healing Diabetic Foot Ulcers: A Hospital-Based Randomized Controlled Trial.,"To validate the efficacy of recombinant human epidermal growth factor (hEGH) in healing diabetic foot ulcers (DFUs) at biochemical and molecular levels. A total of 50 noninfected DFU subjects were recruited for the study and divided into 2 groups based on the treatment application on the subjects. Group 1: DFU subjects treated with hEGH gel-based product called Regen-D 150 (n = 27) and group 2: DFU subjects treated with alternative placebo as the control group (n = 23). Patients were observed for 30 days and punch biopsy was taken at days 0 and 14. Histologic analysis was done to study the matrix alignment, cellular infiltration, and differentiation of epithelial layers. Biochemical analysis was done to quantitatively estimate the amount of collagen and proteoglycans regenerated in the wound area. Complete healing of ulcers was observed in 21 (78%) subjects in group 1, whereas only 12 (52%) subjects among group 2 reported of complete healing of ulcer after completion of the study period of 30 days. Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples. Healing time of the wound among the group 1 subjects was significantly less than the group 2 subjects (45 ± 12 vs 72 ± 18 days, P < .0001) and even showed a better blood glucose level. Early and regular application of the hEGH on DFUs will lead to prevention of leg amputations and would serve to act as a major treatment therapy for healing of chronic wounds.",2020,Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples.,"['Healing Diabetic Foot Ulcers', 'healing diabetic foot ulcers (DFUs', '50 noninfected DFU subjects']","['hEGH gel-based product called Regen-D 150', 'Recombinant Human Epidermal Growth Factor (Regen-D 150', 'recombinant human epidermal growth factor (hEGH', 'hEGH', 'DFU subjects treated with alternative placebo']","['blood glucose level', 'complete healing of ulcer', 'Healing time', 'Collagen and fibroblasts', 'Complete healing of ulcers']","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1509244', 'cui_str': 'nepidermin'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016030', 'cui_str': 'Fibroblasts'}]",,0.0185808,Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples.,"[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Viswanathan', 'Affiliation': 'MV Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre, WHO Collaborating Centre for Research, Education and Training in Diabetes & IDF Centre for Excellence in Diabetes Care, Chennai, India.'}, {'ForeName': 'Udyama', 'Initials': 'U', 'LastName': 'Juttada', 'Affiliation': 'MV Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre, WHO Collaborating Centre for Research, Education and Training in Diabetes & IDF Centre for Excellence in Diabetes Care, Chennai, India.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Babu', 'Affiliation': 'Central Leather Research Institute (CLRI), Chennai, India.'}]",The international journal of lower extremity wounds,['10.1177/1534734619892791'] 923,30951920,Sexual Function following Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy: Secondary Analysis of a Randomized Trial by the Italian Society of Gynecological Endoscopy Using a Validated Questionnaire.,"STUDY OBJECTIVE The effect of the different types of vaginal cuff closures on posthysterectomy sexual function has not been investigated in depth. We evaluated if there is a difference between transvaginal versus a laparoscopic closure after total laparoscopic hysterectomy (TLH) on female sexual function, using a validated questionnaire. DESIGN Secondary analysis of a prospective randomized controlled trial. SETTING Three academic research centers. PATIENTS Women consenting to telephone interviews on their sexual life before and after undergoing TLH were included. INTERVENTIONS Patients were randomly assigned to a laparoscopic or transvaginal approach for vaginal cuff closure at the end of TLH for benign indications. MEASUREMENTS AND MAIN RESULTS A validated questionnaire (the Female Sexual Function Index [FSFI]) was used to explore sexuality before and after the operation. Of the 1408 patients enrolled in the primary study, 400 patients were asked to complete the questionnaire. Of them, 182 (41.4%) were eligible and accepted enrollment in the present analysis. No difference was found in terms of pre- and postoperative FSFI scores between groups. Patients with a low preoperative FSFI score (<26.55) had a significantly higher likelihood of having a postoperative sexual disorder (p <.001). Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively). After multivariable analysis, both variables maintained at least a tendency toward an association with a lower postoperative FSFI score (odds ratio, 2.696; 95% confidence interval, 1.010-7.194; p = 0.048 and p = 0.053; odds ratio, 13.2; 95% confidence interval, .966-180.5, respectively). CONCLUSION Transvaginal and laparoscopic cuff closures after TLH have similar sexual postoperative outcomes. A patient with sexual problems before TLH is more likely to have a low FSFI score postoperatively. Premenopausal patients undergoing bilateral ovariectomy and those with postoperative vaginal cuff hematoma have a worse postoperative sexual life. (Clinicaltrials.gov, protocol number NCT02453165, registration date May 25, 2015.).",2020,"Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively).","['Three academic research centers', '1408 patients enrolled in the primary study, 400 patients', 'Women consenting to telephone interviews on their sexual life before and after undergoing TLH were included', 'Premenopausal patients undergoing bilateral ovariectomy and those with postoperative vaginal cuff hematoma']","['vaginal cuff closures', 'Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy', 'laparoscopic or transvaginal approach', 'transvaginal versus a laparoscopic closure after total laparoscopic hysterectomy (TLH']","['low preoperative FSFI score', 'likelihood of having a postoperative sexual disorder', 'pre- and postoperative FSFI scores', 'postoperative FSFI score', 'postoperative sexual life', 'Sexual Function']","[{'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0278321', 'cui_str': 'Castration, Female'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]","[{'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0549115', 'cui_str': 'Structure of vaginal vault'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",400.0,0.261765,"Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Uccella', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Uccella, Ferrari, and Zorzato), Ospedale degli Infermi, Biella, Italy; Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy. Electronic address: stefucc@libero.it.'}, {'ForeName': 'Vito Andrea', 'Initials': 'VA', 'LastName': 'Capozzi', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy; Obstetrics and Gynecology Department (Drs. Capozzi and Berretta), University of Parma, Parma, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': ""Ricco'"", 'Affiliation': ""Service for Health and Safety on the Workplaces (Dr. Ricco'), AUSL - I.R.C.C.S. di Reggio Emilia, Italy.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Perrone', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Zanello', 'Affiliation': ""Minimally Invasive Gynecological Surgery Unit (Drs. Zanello and Seracchioli), Sant'Orsola-Malpighi Hospital, Bologna, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Uccella, Ferrari, and Zorzato), Ospedale degli Infermi, Biella, Italy.'}, {'ForeName': 'Pier Carlo', 'Initials': 'PC', 'LastName': 'Zorzato', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Uccella, Ferrari, and Zorzato), Ospedale degli Infermi, Biella, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Seracchioli', 'Affiliation': ""Minimally Invasive Gynecological Surgery Unit (Drs. Zanello and Seracchioli), Sant'Orsola-Malpighi Hospital, Bologna, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cromi', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Cromi, Serati, and Ghezzi), University of Insubria, Del Ponte Hospital, Varese, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Serati', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Cromi, Serati, and Ghezzi), University of Insubria, Del Ponte Hospital, Varese, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Ergasti', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfani', 'Affiliation': 'Department of Medicine and Aging Sciences (Dr. Fanfani), University ""Gabriele d\'Annunzio"" of Chieti-Pescara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berretta', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Capozzi and Berretta), University of Parma, Parma, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Malzoni', 'Affiliation': 'Endoscopica Malzoni-Center for Advanced Endoscopic Gynecological Surgery (Dr. Malzoni), Avellino, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cianci', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Vizza', 'Affiliation': 'Department of Oncological Surgery, Gynecologic Oncologic Unit (Dr. Vizza), ""Regina Elena"" National Cancer Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guido', 'Affiliation': 'Division of Gynaecology, Department of Obstetrics and Gynaecology (Drs. Guido and Legge), ""F. Miulli"" General Hospital, Acquaviva delle Fonti, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Legge', 'Affiliation': 'Division of Gynaecology, Department of Obstetrics and Gynaecology (Drs. Guido and Legge), ""F. Miulli"" General Hospital, Acquaviva delle Fonti, Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ciravolo', 'Affiliation': 'Department of Obstetrics and Gynecology (Dr. Ciravolo), Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gueli Alletti', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Cromi, Serati, and Ghezzi), University of Insubria, Del Ponte Hospital, Varese, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Candiani', 'Affiliation': 'Gynecology Department (Dr. Candiani), IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.03.018'] 924,30084706,Functional and structural plasticity following action observation training in multiple sclerosis.,"BACKGROUND Hand motor deficits contribute to multiple sclerosis (MS)-related disability. Action observation training (AOT) is promising to improve upper limb function in neurologic patients. OBJECTIVES In this preliminary study, we investigated AOT effects on dominant-hand motor performance in MS patients with upper limb motor impairment and performed an explorative analysis of their anatomical and functional magnetic resonance imaging (MRI) substrates. METHODS In total, 46 healthy controls (HC) and 41 MS patients with dominant-hand motor impairment were randomized to AOT (HC-AOT = 23; MS-AOT = 20; watching daily-life action videos and execution) or control-training (HC-Control = 23; MS-Control = 21; watching landscapes videos and execution). Behavioral, structural, and functional (at rest and during object manipulation) MRI scans were acquired before and after a 2-week training. RESULTS After training, MS groups improved in right upper limb functions, mainly in AOT group ( p from 0.02 to 0.0001). All groups showed regional increased and decreased gray matter volume, with specific AOT effects in fronto-temporal areas in MS-AOT ( p  < 0.001), without white matter (WM) integrity modifications. Increased and reduced recruitments of the action observation matching system and its connections in MS-AOT were found ( p  < 0.001). Motor improvements were correlated with volumetric and functional MRI modifications ( r from -0.78 to 0.77, p  < 0.001). CONCLUSION The 10-day AOT promotes clinical improvements in MS patients through structural and functional modifications of the action observation matching system.",2019,"After training, MS groups improved in right upper limb functions, mainly in AOT group ( p from 0.02 to 0.0001).","['multiple sclerosis', 'MS patients with upper limb motor impairment', 'neurologic patients', '46 healthy controls (HC) and 41 MS patients with dominant-hand motor impairment']","['Action observation training (AOT', 'AOT (HC-AOT\u2009=\u200923; MS-AOT\u2009=\u200920; watching daily-life action videos and execution) or control-training (HC-Control\u2009=\u200923; MS-Control\u2009=\u200921; watching landscapes videos and execution', 'action observation training']","['gray matter volume, with specific AOT effects', 'MRI scans', 'action observation matching system and its connections in MS-AOT', 'right upper limb functions', 'Behavioral, structural, and functional (at rest and during object manipulation', 'volumetric and functional MRI modifications']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand (attribute)'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",46.0,0.018211,"After training, MS groups improved in right upper limb functions, mainly in AOT group ( p from 0.02 to 0.0001).","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy/Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Meani', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Fumagalli', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Pagani', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gatti', 'Affiliation': 'Laboratory of Movement Analysis, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy/Humanitas University and Humanitas Clinical and Research Center, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Martinelli-Boneschi', 'Affiliation': 'Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Esposito', 'Affiliation': 'Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Preziosa', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy/Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cordani', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy/Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458518792771'] 925,31778021,Randomized controlled double-blind study of a cleanser composed of 5-aminolevulinic acid and peptides on mild and moderate acne vulgaris.,"BACKGROUND Existing treatments of acne vulgaris may be complicated or elicit undesirable side effects. Therefore, new and safe therapeutic modalities are needed. OBJECTIVES We investigated the effects of a cleanser with 5-aminolevulinic acid and peptides on mild to moderate acne vulgaris. METHODS Sixty volunteers with mild to moderate acne vulgaris (IGA grade II-III) were randomly assigned to treatment or control groups of thirty respectively. Participants cleansed their faces twice a day for 8 weeks with either a cleanser with 5-aminolevulinic acid and peptides (treatment) or with basic cleanser (control). The number of acne lesions (comedones, papules, pustules, and nodules), Michaelson's acne severity, and IGA were measured every 2 weeks and patient satisfaction and adverse events at week 8. RESULTS Mean number of inflammatory acne lesions in treatment group decreased from 5.9 at baseline to 4.5 at week 4 and 4.1 at week 8 (in particular, P < .05). The mean number of noninflammatory lesions in treatment group decreased from 11.4 at baseline to 8.8 at week 4 and 7.4 at week 8 (in particular, P < .05). The mean value of Michaelson's acne severity index and IGA in treatment group also decreased from baseline to week 4 and week 8 (both in particular, P < .05). Investigator's assessment and patient satisfaction in treatment group at week 8 were better than control group. Adverse events in two groups were similar. CONCLUSIONS We think the cleanser with 5-aminolevulinic acid and peptides is a useful and safe therapeutic agent for mild to moderate acne vulgaris.",2020,"The mean number of noninflammatory lesions in treatment group decreased from 11.4 at baseline to 8.8 at week 4 and 7.4 at week 8 (in particular, P ","['mild to moderate acne vulgaris', 'mild and moderate acne vulgaris', 'Sixty volunteers with mild to moderate acne vulgaris (IGA grade II-III']","['5-aminolevulinic acid and peptides', 'cleanser', 'cleanser with 5-aminolevulinic acid and peptides (treatment) or with basic cleanser (control', 'cleanser with 5-aminolevulinic acid and peptides']","[""Investigator's assessment and patient satisfaction"", ""mean value of Michaelson's acne severity index and IGA"", 'Adverse events', ""number of acne lesions (comedones, papules, pustules, and nodules), Michaelson's acne severity, and IGA"", 'mean number of noninflammatory lesions', 'Mean number of inflammatory acne lesions']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0221228', 'cui_str': 'Comedone (disorder)'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}]",60.0,0.0232803,"The mean number of noninflammatory lesions in treatment group decreased from 11.4 at baseline to 8.8 at week 4 and 7.4 at week 8 (in particular, P ","[{'ForeName': 'Hyun Ji', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Kyung Duck', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Weon Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13232'] 926,31276165,Treatment-Specific Composition of the Gut Microbiota Is Associated With Disease Remission in a Pediatric Crohn's Disease Cohort.,"BACKGROUND The beneficial effects of antibiotics in Crohn's disease (CD) depend in part on the gut microbiota but are inadequately understood. We investigated the impact of metronidazole (MET) and metronidazole plus azithromycin (MET+AZ) on the microbiota in pediatric CD and the use of microbiota features as classifiers or predictors of disease remission. METHODS 16S rRNA-based microbiota profiling was performed on stool samples from 67 patients in a multinational, randomized, controlled, longitudinal, 12-week trial of MET vs MET+AZ in children with mild to moderate CD. Profiles were analyzed together with disease activity, and then used to construct random forest models to classify remission or predict treatment response. RESULTS Both MET and MET+AZ significantly decreased diversity of the microbiota and caused large treatment-specific shifts in microbiota structure at week 4. Disease remission was associated with a treatment-specific microbiota configuration. Random forest models constructed from microbiota profiles before and during antibiotic treatment with metronidazole accurately classified disease remission in this treatment group (area under the curve [AUC], 0.879; 95% confidence interval, 0.683-0.9877; sensitivity, 0.7778; specificity, 1.000; P < 0.001). A random forest model trained on pre-antibiotic microbiota profiles predicted disease remission at week 4 with modest accuracy (AUC, 0.8; P = 0.24). CONCLUSIONS MET and MET+AZ antibiotic regimens in pediatric CD lead to distinct gut microbiota structures at remission. It may be possible to classify and predict remission based in part on microbiota profiles, but larger cohorts will be needed to realize this goal.",2019,"RESULTS Both MET and MET+AZ significantly decreased diversity of the microbiota and caused large treatment-specific shifts in microbiota structure at week 4.","['16S rRNA-based microbiota profiling was performed on stool samples from 67 patients in a multinational', 'children with mild to moderate CD', ""Crohn's disease (CD""]","['metronidazole', 'MET+AZ', 'metronidazole (MET) and metronidazole plus azithromycin (MET+AZ']","['disease remission', 'Disease remission', 'classified disease remission']","[{'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.028647,"RESULTS Both MET and MET+AZ significantly decreased diversity of the microbiota and caused large treatment-specific shifts in microbiota structure at week 4.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sprockett', 'Affiliation': 'Department of Microbiology & Immunology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Fischer', 'Affiliation': 'Division of Infectious Diseases & Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Rotem Sigall', 'Initials': 'RS', 'LastName': 'Boneh', 'Affiliation': 'Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'The Juliet Keidan Institute of Pediatric Gastroenterology & Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jarek', 'Initials': 'J', 'LastName': 'Kierkus', 'Affiliation': ""Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Sladek', 'Affiliation': 'Department of Pediatrics, Gastroenterology and Nutrition, Jagiellonian University Medical College, Cracow, Poland.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Escher', 'Affiliation': ""Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Wine', 'Affiliation': 'Division of Pediatric Gastroenterology and Nutrition, Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Pediatric Gastroenterology Unit, Soroka University Medical Center, and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Jorge Amil', 'Initials': 'JA', 'LastName': 'Dias', 'Affiliation': 'Department of Pediatrics, Hospital de Sao Joao, Porto, Portugal.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': ""Pediatric Gastroenterology Unit, Ruth Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kori', 'Affiliation': 'Pediatric Day Care Unit, Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Snapper', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Holmes', 'Affiliation': 'Department of Statistics, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Bousvaros', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Relman', 'Affiliation': 'Department of Microbiology & Immunology, Stanford University School of Medicine, Stanford, California, USA.'}]",Inflammatory bowel diseases,['10.1093/ibd/izz130'] 927,31562875,Effectiveness of Paraffin and Sustained Stretch in Treatment of Shoulder Contractures Following a Burn Injury.,"OBJECTIVE To examine if range of motion of the shoulder treated with paraffin will be better than that of the shoulder treated with sustained stretch alone. DESIGN Pilot randomized controlled trial. SETTING Regional burn center. PARTICIPANTS Patients (N=23) who sustained a burn injury, with a shoulder active abduction and/or flexion in the +70° to +150° degree range, who were 14 years or older, were receiving follow-up physical therapy after discharge from hospital, and provided a signed consent to participate. INTERVENTIONS Group A received sustained stretch and paraffin, and group B received sustained stretch only. Both groups had 6 sessions of treatment over 2 weeks. MAIN OUTCOME MEASURES Active range of motion (AROM) and active-assisted range of motion (AAROM) for shoulder flexion (SF) and shoulder abduction (SA) were measured before and after each treatment session. RESULTS For pretreatment measurements, only the results for SF AAROM had significant time effects. For posttreatment measurements, SF AROM and SF AAROM had significant effects for time. Session 1 was significantly lower than sessions 2, 3, 4, and 6 for both measures, and additionally, session 1 was significantly lower than session 5 for SF AAROM. For SA AROM, a group-by-time interaction effect was significant, with scores for the paraffin group relatively stable across sessions, and the nonparaffin group had peaks at sessions 3 and 6. There were no significant effects for (1) within-session changes to examine improvement during a session or (2) presession scores across the 6 sessions showing maintenance of motion. Total change from the first session presession measurement to the sixth session postsession measurement for the 2 treatment groups were nonsignificantly different. CONCLUSIONS As shown in this study, sustained stretching with paraffin may be a valuable adjunct to range of motion intervention for the shoulder after burn injury.",2020,"Session 1 was found to be significantly lower than sessions 2, 3, 4, and 6 for both measures and additionally session 1 was significantly lower than session 5 for SF-AAROM.","[' Patients (N=23) who sustained a burn injury, with an shoulder active abduction and/or flexion in the +70°- +150° degree, who were ≥ 14 years of age, receiving follow-up physical therapy after discharge from hospital, and provided a signed consent to participate', 'Shoulder Contractures following a Burn Injury']","['paraffin', 'sustained stretch and paraffin and Group B received sustained stretch only', 'Paraffin and Sustained Stretch']","['Active Range of Motion (AROM) and Active-Assisted Range of Motion (AAROM) for Shoulder Flexion ', 'SF-AROM and SF-AAROM)) and Shoulder Abduction (SA-AROM and SA-AAROM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}]",,0.0436857,"Session 1 was found to be significantly lower than sessions 2, 3, 4, and 6 for both measures and additionally session 1 was significantly lower than session 5 for SF-AAROM.","[{'ForeName': 'Radha K', 'Initials': 'RK', 'LastName': 'Holavanahalli', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: Radha.holavanahalli@utsouthwestern.edu.'}, {'ForeName': 'Phala A', 'Initials': 'PA', 'LastName': 'Helm', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Kowalske', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': 'Department of Clinical Sciences, Division of Biostatistics, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.08.482'] 928,31886820,"Letter to the editor: Comment on Positive Effects of ""Textured Lunches"" Gatherings and Oral Exercises Combined with Physical Exercises on Oral and Physical Function in Older Individuals: A Cluster Randomized Controlled Trial.",,2020,,['Older Individuals'],['Oral Exercises Combined with Physical Exercises'],['Oral and Physical Function'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0655917,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hashimoto', 'Affiliation': 'Chihiro Hashimoto, Department of Nutrition, Nursing home Kagayanomori, 5-4-23 Kitakagaya, Suminoe Ward, Osaka city, Japan. Code; 559-0011, Tel: +81-6-6686-5301 Fax: +81-6-6686-5302, E-mail: chihiro6315@yahoo.co.jp.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Uno', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1281-z'] 929,31828492,Food Purchasing Behavior of Food Insecure Cancer Patients Receiving Supplemental Food Vouchers.,"PURPOSE Food insecure cancer patients experience worse health outcomes and poorer quality of life than food secure patients. There has been little research in programs to alleviate food insecurity in cancer patients. The objective of this paper is to report on the food purchasing behaviors of cancer patients enrolled in a supplemental food voucher program. METHODS This paper utilized data from a three-arm randomized controlled trial investigating the impact of food interventions on alleviating food insecurity in cancer patients receiving chemotherapy and/or radiation therapy. In one arm, patients received a monthly $230 voucher with which to purchase food. Receipts were collected for items purchased with the voucher and were coded to analyze purchasing behaviors. RESULTS Thirty-three patients provided receipts for more than 11,000 individual items. Patients spent 50% of voucher funds on animal protein, fruits, and vegetables. Patients spent, on average, 77% of voucher funds on items categorized as ""healthy."" CONCLUSIONS Patients who received a food voucher purchased more fruits and vegetables than national averages would suggest. They also spent less on sweetened beverages than national samples. Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients. Supplemental food vouchers for food insecure cancer patients resulted in the purchase of healthy food items.",2020,Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients.,"['cancer patients enrolled in a supplemental food voucher program', 'Food Insecure Cancer Patients Receiving Supplemental Food Vouchers', 'food insecure cancer patients', 'cancer patients receiving chemotherapy and/or radiation therapy', 'Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients', 'cancer patients']","['food interventions', 'Supplemental food vouchers']","['quality of life', 'purchase of healthy food items']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0034380'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",33.0,0.0469702,Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients.,"[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Paolantonio', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Soo Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ramirez', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Roberts-Eversley', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Melnic', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Minlun', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Devika R', 'Initials': 'DR', 'LastName': 'Jutagir', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Modupe', 'Initials': 'M', 'LastName': 'Oladele', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gany', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Department of Medicine, and Department of Public Health, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. ganyf@mskcc.org.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05183-4'] 930,31759465,Single-item teacher stress and coping measures: Concurrent and predictive validity and sensitivity to change.,"This study examined the concurrent and predictive validity of single-item scales for assessing teacher stress and coping. Correlations between the stress and coping items and present and end-of-year teacher-reported burnout and self-efficacy generally aligned with hypotheses, with stronger associations between coping and burnout and self-efficacy in comparison to the associations between stress and burnout and self-efficacy. Stress and coping items also predicted concurrent and future emotional exhaustion controlling for covariates; however, only coping consistently predicted additional variance in future emotional exhaustion with both stress and coping items in the model. Further, the coping item, not the stress item, demonstrated sensitivity to detect intervention effects; that is, teachers randomly assigned to receive a classroom management intervention (the Incredible Years Teacher Classroom Management program) had significantly higher coping scores compared to a wait-list comparison group. The results of this study provide support for the continued use of single-item stress and coping measures of teacher well-being, and areas for further research and potential use of these measures are discussed.",2019,"Stress and coping items also predicted concurrent and future emotional exhaustion controlling for covariates; however, only coping consistently predicted additional variance in future emotional exhaustion with both stress and coping items in the model.",[],['classroom management intervention'],['coping scores'],[],[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0141741,"Stress and coping items also predicted concurrent and future emotional exhaustion controlling for covariates; however, only coping consistently predicted additional variance in future emotional exhaustion with both stress and coping items in the model.","[{'ForeName': 'Colleen L', 'Initials': 'CL', 'LastName': 'Eddy', 'Affiliation': 'University of Missouri, Columbia, United States of America. Electronic address: colleen.eddy@mail.missouri.edu.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Herman', 'Affiliation': 'University of Missouri, Columbia, United States of America.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Reinke', 'Affiliation': 'University of Missouri, Columbia, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2019.05.001'] 931,31759466,Long-term impacts of the CARE program on teachers' self-reported social and emotional competence and well-being.,"Teacher stress is at an all-time high, negatively impacting the quality of education and student outcomes. In recent years, mindfulness-based interventions have been shown to promote well-being and reduce stress among healthy adults. In particular, mindfulness-based interventions enhance emotion regulation and reduce psychological distress. One such program specifically designed to address teacher stress is Cultivating Awareness and Resilience in Education (CARE). The present study examined teachers' self-reported data collected at three time points over two consecutive school years as part of a randomized controlled trial of CARE. The study involved 224 teachers in 36 elementary schools in high poverty areas of New York City. Teachers were randomly assigned within schools to receive CARE or to a waitlist control group. This study builds on previous experimental evidence of the impacts of CARE on teacher self-reported outcomes for this sample of teachers within one school year (Jennings et al., 2017). Results indicate that at the third assessment point (9.5 months after participating in the program), CARE teachers showed continued significant decreases in psychological distress, reductions in ache-related physical distress, continued significant increases in emotion regulation and some dimensions of mindfulness. Findings indicate that teachers who participated in mindfulness-based professional development through CARE reported both sustained and new benefits regarding their well-being at a follow-up assessment almost one-year post-intervention compared to teachers in the control condition. Implications for further research and policy are discussed.",2019,"In recent years, mindfulness-based interventions have been shown to promote well-being and reduce stress among healthy adults.","['healthy adults', '224 teachers in 36 elementary schools in high poverty areas of New York City']","['CARE program', 'CARE or to a waitlist control group']","[""teachers' self-reported social and emotional competence"", 'psychological distress', 'emotion regulation and some dimensions of mindfulness', 'psychological distress, reductions in ache-related physical distress']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032855', 'cui_str': 'Poverty Areas'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0234238', 'cui_str': 'Ache'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",224.0,0.0126363,"In recent years, mindfulness-based interventions have been shown to promote well-being and reduce stress among healthy adults.","[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Jennings', 'Affiliation': 'University of Virginia, USA. Electronic address: tishjennings@virginia.edu.'}, {'ForeName': 'Sebrina', 'Initials': 'S', 'LastName': 'Doyle', 'Affiliation': 'Fordham University, USA. Electronic address: sld40@psu.edu.'}, {'ForeName': 'Yoonkyung', 'Initials': 'Y', 'LastName': 'Oh', 'Affiliation': 'Fordham University, USA. Electronic address: yoonkyung.oh@uth.tmc.edu.'}, {'ForeName': 'Damira', 'Initials': 'D', 'LastName': 'Rasheed', 'Affiliation': 'Pennsylvania State University, USA. Electronic address: drasheed@gradcenter.cuny.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Frank', 'Affiliation': 'Fordham University, USA. Electronic address: jfrank@psu.edu.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Brown', 'Affiliation': 'Pennsylvania State University, USA. Electronic address: cjobrown@fordham.edu.'}]",Journal of school psychology,['10.1016/j.jsp.2019.07.009'] 932,31539169,Acceptance and commitment therapy for breast cancer survivors with fear of cancer recurrence: A 3-arm pilot randomized controlled trial.,"BACKGROUND Fear of cancer recurrence (FCR) has a profound negative impact on quality of life (QOL) for many cancer survivors. Breast cancer survivors (BCS) are particularly vulnerable, with up to 70% reporting clinically significant FCR. To the authors' knowledge, evidence-based interventions for managing FCR are limited. Acceptance and commitment therapy (ACT) promotes psychological flexibility in managing life's stressors. The current study examined the feasibility and preliminary efficacy of group-based ACT for FCR in BCS. METHODS Post-treatment BCS (91 patients with stage I-III disease) with clinical FCR randomly were assigned to ACT (6 weekly 2-hour group sessions), survivorship education (SE; 6 weekly 2-hour group sessions), or enhanced usual care (EUC; one 30-minute group coaching session with survivorship readings). FCR severity (primary outcome) and avoidant coping, anxiety, post-traumatic stress, depression, QOL, and other FCR-related variables (secondary outcomes) were assessed at baseline (T1), after the intervention (T2), 1 month after the intervention (T3), and 6 months after the intervention (T4) using intent-to-treat analysis. RESULTS Satisfactory recruitment (43.8%) and retention (94.5%) rates demonstrated feasibility. Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen d for effect sizes, 0.80; P < .001) and EUC (Cohen d, 0.61; P < .01). For 10 of 12 secondary outcomes, only ACT produced significant within-group reductions across all time points. By T4, significant moderate to large between-group comparisons favored ACT over SE and EUC with regard to avoidant coping, anxiety, depression, QOL, and FCR-related psychological distress. CONCLUSIONS Group-based ACT is a feasible and promising treatment for FCR and associated outcomes in BCS that warrants testing in larger, fully powered trials.",2020,"Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen","['Post-treatment BCS (91 patients with stage I-III disease) with clinical FCR randomly', 'breast cancer survivors\xa0with fear of cancer recurrence', 'Breast cancer\xa0survivors (BCS']","['Acceptance and commitment therapy (ACT', 'survivorship education (SE; 6\xa0weekly 2-hour group sessions), or enhanced usual care (EUC; one\xa030-minute group coaching session with survivorship readings', 'ACT']","['quality of life (QOL', 'FCR severity', 'avoidant coping, anxiety, depression, QOL, and FCR-related psychological distress', 'FCR severity (primary outcome) and avoidant coping, anxiety, post-traumatic stress, depression, QOL, and other FCR-related variables (secondary outcomes']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0038955'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",91.0,0.11198,"Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen","[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Johns', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Patrick V', 'Initials': 'PV', 'LastName': 'Stutz', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Tasneem L', 'Initials': 'TL', 'LastName': 'Talib', 'Affiliation': 'Center for Health Services Research, Regenstrief Institute, Inc., Indianapolis, Indiana.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Cohee', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, Indiana.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Beck-Coon', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, West Virginia University School of Medicine, Charleston, West Virginia.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'LaPradd', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, Indiana.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'R Brian', 'Initials': 'RB', 'LastName': 'Giesler', 'Affiliation': 'Department of Psychology, Butler University, Indianapolis, Indiana.'}]",Cancer,['10.1002/cncr.32518'] 933,31621175,A randomized trial comparing bipolar transurethral vaporization of the prostate with GreenLight laser (xps-180watt) photoselective vaporization of the prostate for treatment of small to moderate benign prostatic obstruction: outcomes after 2 years.,"OBJECTIVE To test the non-inferiority of bipolar transurethral vaporization of the prostate (TUVP) compared to GreenLight laser (GL) photoselective vaporization of the prostate (PVP) for reduction of benign prostatic hyperplasia-related lower urinary tract symptoms in a randomized trial. METHODS Eligible patients with prostate volumes of 30-80 mL were randomly allocated to GL-PVP (n = 58) or bipolar TUVP (n = 61). Non-inferiority of symptom score (International Prostate Symptom Score [IPSS]) at 24 months was evaluated. All peri-operative variables were recorded and compared. Urinary (IPSS, maximum urinary flow rate and post-void residual urine volume) and sexual (International Index of Erectile Function-15) outcome measures were evaluated at 1, 4, 12 and 24 months. Need for retreatment and complications, change in PSA level and health resources-related costs of both procedures were recorded and compared. RESULTS Baseline and peri-operative variables were similar in the two groups. At 1, 4, 12 and 24 months, 117, 116, 99 and 96 patients, respectively, were evaluable. Regarding urinary outcome measures, there was no significant difference between the groups. The mean ± sd IPSS at 1 and 2 years was 7.1 ± 3 and 7.9 ± 2.9 (P = 0.8), respectively, after GL-PVP and 6.3 ± 3.1 and 7.2 ± 2.8, respectively, after bipolar TUVP (P = 0.31). At 24 months, the mean difference in IPSS was 0.7 (95% confidence interval -0.6 to 2.3; P = 0.6). The median (range) postoperative PSA reduction was 64.7 (25-99)% and 65.9 (50-99)% (P = 0.006) after GL-PVP, and 32.1 (28.6-89.7)% and 39.3 (68.8-90.5)% (P = 0.005) after bipolar TUVP, at 1 and 2 years, respectively. After 2 years, retreatment for recurrent bladder outlet obstruction was reported in eight (13.8%) and 10 (16.4%) patients in the GL-PVP and bipolar TUVP groups, respectively (P = 0.8). The mean estimated cost per bipolar TUVP procedure was significantly lower than per GL-PVP procedure after 24 months (P = 0.01). CONCLUSIONS In terms of symptom control, bipolar TUVP was not inferior to GL-PVP at 2 years. Durability of the outcome needs to be tracked. The greater cost of GL-PVP compared with bipolar TUVP is an important concern.",2020,The mean estimated cost per B.TUVP procedure was significantly lower than per GL.PVP procedure after 24 months (P=0.01),"['Eligible patients with 30-80ml prostate', 'small to moderate Benign Prostatic Obstruction']","['Greenlight laser (GL.PVP) vaporization', 'GL.PVP', 'GL.PVP/XPS TM (58) and B.TUVP', 'Bipolar (B.TUVP', 'Bipolar Transurethral Vaporization of the Prostate versus GreenLight Laser (XPS-180Watt) Photoselective Vaporization']","['recurrent BOO', 'Urinary (IPSS, Q.max and PVR) and sexual (IIEF-15) outcome measures', 'mean estimated cost per B.TUVP procedure', 'Mean IPSS', 'IPSS', 'Median postoperative PSA reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction (disorder)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0846611,The mean estimated cost per B.TUVP procedure was significantly lower than per GL.PVP procedure after 24 months (P=0.01),"[{'ForeName': 'Fady K', 'Initials': 'FK', 'LastName': 'Ghobrial', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shoma', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elshal', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nasr', 'Initials': 'N', 'LastName': 'El-Tabey', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Nabeeh', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Shokeir', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",BJU international,['10.1111/bju.14926'] 934,31752105,Vitamin B12 Status Upon Short-Term Intervention with a Vegan Diet-A Randomized Controlled Trial in Healthy Participants.,"Vegans are at an increased risk for certain micronutrient deficiencies, foremost of vitamin B 12 . Little is known about the short-term effects of dietary change to plant-based nutrition on vitamin B 12 metabolism. Systemic biomarkers of vitamin B 12 status, namely, serum vitamin B 12 and holotranscobalamin, may respond quickly to a reduced intake of vitamin B 12 . To test this hypothesis, 53 healthy omnivore subjects were randomized to a controlled unsupplemented vegan diet (VD, n = 26) or meat-rich diet (MD, n = 27) for 4 weeks. Vitamin B 12 status was examined by measurement of serum vitamin B 12 , holotranscobalamin (holo-TC), methylmalonic acid (MMA) and total plasma homocysteine (tHcy). Holo-TC decreased significantly in the VD compared to the MD group after four weeks of intervention, whereas metabolites MMA and tHcy were unaffected. Body weight remained stable in both groups. VD intervention led to a significant reduction of cholesterol intake, and adequate profiles of nutrient and micronutrient status. Lower intake of vitamin B 12 was observed in VD, which was mirrored by a lower concentration of serum vitamin B 12 and reduced holo-TC after 4 weeks. Plasma holo-TC may be a fast-responding biomarker to monitor adequate supply of vitamin B 12 in plant-based individuals.",2019,"Lower intake of vitamin B 12 was observed in VD, which was mirrored by a lower concentration of serum vitamin B 12 and reduced holo-TC after 4 weeks.","['53 healthy omnivore subjects', 'Healthy Participants']","['Vitamin B12 Status Upon Short-Term Intervention with a Vegan Diet', 'controlled unsupplemented vegan diet (VD, n = 26) or meat-rich diet', 'VD intervention']","['Holo-TC', 'cholesterol intake, and adequate profiles of nutrient and micronutrient status', 'Body weight', 'metabolites MMA and tHcy', 'serum vitamin B 12 , holotranscobalamin (holo-TC), methylmalonic acid (MMA) and total plasma homocysteine (tHcy']","[{'cui': 'C0562693', 'cui_str': 'Omnivore (organism)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0344353', 'cui_str': 'Vegan dietary (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0025787', 'cui_str': 'Propanedioic acid, methyl-'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}]",53.0,0.017123,"Lower intake of vitamin B 12 was observed in VD, which was mirrored by a lower concentration of serum vitamin B 12 and reduced holo-TC after 4 weeks.","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Lederer', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Hannibal', 'Affiliation': 'Laboratory of Clinical Biochemistry and Metabolism, Department of General Pediatrics, Medical Center-University of Freiburg, Adolescent Medicine and Neonatology, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hettich', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Behringer', 'Affiliation': 'Laboratory of Clinical Biochemistry and Metabolism, Department of General Pediatrics, Medical Center-University of Freiburg, Adolescent Medicine and Neonatology, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Spiekerkoetter', 'Affiliation': 'Laboratory of Clinical Biochemistry and Metabolism, Department of General Pediatrics, Medical Center-University of Freiburg, Adolescent Medicine and Neonatology, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Steinborn', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Gründemann', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Amy Marisa', 'Initials': 'AM', 'LastName': 'Zimmermann-Klemd', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Simmet', 'Affiliation': 'Institute of Pharmacology of Natural Products & Clinical Pharmacology, Ulm University, 89081 Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schmiech', 'Affiliation': 'Institute of Pharmacology of Natural Products & Clinical Pharmacology, Ulm University, 89081 Ulm, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Maul-Pavicic', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Samstag', 'Affiliation': 'Institute of Immunology, Section Molecular Immunology, University of Heidelberg, 69120 Heidelberg, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Huber', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}]",Nutrients,['10.3390/nu11112815'] 935,29157055,Haptotherapy as a new intervention for treating fear of childbirth: a randomized controlled trial.,"OBJECTIVE To evaluate the effect of haptotherapy on severe fear of childbirth in pregnant women. DESIGN Randomized controlled trial. SETTING Community midwifery practices and a teaching hospital in the Netherlands. POPULATION OR SAMPLE Primi- and multigravida, suffering from severe fear of childbirth (N = 134). METHODS Haptotherapy, psycho-education via Internet and care as usual were randomly assigned at 20-24 weeks of gestation and the effects were compared at 36 weeks of gestation and 6 weeks and 6 months postpartum. Repeated measurements ANOVA were carried out on the basis of intention to treat. Since there were crossovers from psycho-education via Internet and care as usual to haptotherapy, the analysis was repeated according to the as treated principle. MAIN OUTCOME MEASURES Fear of childbirth score at the Wijma Delivery Expectancy/Experience Questionnaire. RESULTS In the intention to treat analysis, only the haptotherapy group showed a significant decrease of fear of childbirth, F(2,99) = 3.321, p = .040. In the as treated analysis, the haptotherapy group showed a greater reduction in fear of childbirth than the other two groups, F(3,83) = 6.717, p < .001. CONCLUSION Haptotherapy appears to be more effective in reducing fear of childbirth than psycho-education via Internet and care as usual.",2019,"In the intention to treat analysis, only the haptotherapy group showed a significant decrease of fear of childbirth, F(2,99) = 3.321, p = .040.","['Haptotherapy, psycho-education via Internet and care as usual', 'treating fear of childbirth', 'OR SAMPLE\n\n\nPrimi- and multigravida, suffering from severe fear of childbirth (N\u2009=\u2009134', 'pregnant women', 'Community midwifery practices and a teaching hospital in the Netherlands']","['Haptotherapy', 'haptotherapy']","['Fear of childbirth score at the Wijma Delivery Expectancy/Experience Questionnaire', 'fear of childbirth', 'severe fear of childbirth']","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia (finding)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0404831', 'cui_str': 'Multigravida (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]",[],"[{'cui': 'C0522187', 'cui_str': 'Tocophobia (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.197999,"In the intention to treat analysis, only the haptotherapy group showed a significant decrease of fear of childbirth, F(2,99) = 3.321, p = .040.","[{'ForeName': 'Gert A', 'Initials': 'GA', 'LastName': 'Klabbers', 'Affiliation': 'a Department of Medical and Clinical Psychology , Tilburg University , Tilburg , the Netherlands.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Wijma', 'Affiliation': 'b Unit of Medical Psychology, Department of Clinical and Experimental Medicine , Linköping University , Linköping , Sweden.'}, {'ForeName': 'K Marieke', 'Initials': 'KM', 'LastName': 'Paarlberg', 'Affiliation': 'c Department of Obstetrics and Gynaecology , Gelre Hospitals , Apeldoorn location , the Netherlands.'}, {'ForeName': 'Wilco H M', 'Initials': 'WHM', 'LastName': 'Emons', 'Affiliation': 'd Department of Methodology and Statistics , Tilburg University , Tilburg , the Netherlands.'}, {'ForeName': 'Ad J J M', 'Initials': 'AJJM', 'LastName': 'Vingerhoets', 'Affiliation': 'a Department of Medical and Clinical Psychology , Tilburg University , Tilburg , the Netherlands.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2017.1398230'] 936,31812890,Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer.,"OBJECTIVES The J-ALEX study compared the efficacy and safety of alectinib with crizotinib in Japanese patients with advanced ALK-positive non-small-cell lung cancer (NSCLC). Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 % confidence interval [CI]: 0.17-0.71, P < 0.0001). We report final PFS data and the second pre-planned interim analysis of overall survival (OS) and safety (data cutoff: June 30, 2018). METHODS Patients aged ≥20 years who were ALK inhibitor-naïve and chemotherapy-naïve, or had received one prior chemotherapy regimen, were randomized to receive alectinib 300 mg (n = 103) or crizotinib 250 mg (n = 104) twice daily. The primary end point was IRF-assessed PFS. Secondary end points included OS and safety. All patients entered survival follow-up in July 2018. RESULTS Median follow-up was 42.4 months for alectinib and 42.2 months for crizotinib. Sustained improvement in IRF-assessed PFS with alectinib was shown (HR 0.37, 95 % CI: 0.26-0.52; median PFS 34.1 months vs 10.2 months crizotinib). At the second interim OS analysis, superiority of alectinib to crizotinib could not be concluded (stratified HR 0.80, 99.8799 % CI: 0.35-1.82, stratified log-rank P = 0.3860; median OS not reached alectinib vs 43.7 months crizotinib). Fewer alectinib-treated patients experienced grade ≥3 adverse events (36.9 % vs 60.6 % crizotinib). CONCLUSIONS At the final PFS analysis, alectinib continued to demonstrate superiority in IRF-assessed PFS versus crizotinib in ALK-inhibitor-naïve ALK-positive NSCLC, with a favorable safety profile. OS follow-up continues.",2020,"Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 % confidence interval [CI]:","['Patients aged ≥20 years who were ALK inhibitor-naïve and chemotherapy-naïve, or had received one prior chemotherapy regimen', 'Japanese patients with advanced ALK-positive non-small-cell lung cancer (NSCLC']","['alectinib versus crizotinib', 'alectinib 300 mg (n = 103) or crizotinib', 'alectinib with crizotinib']","['IRF-assessed PFS', 'grade ≥3 adverse events', 'overall survival (OS) and safety', 'review facility (IRF)-assessed progression-free survival (PFS', 'OS and safety', 'efficacy and safety', 'IRF-assessed PFS with alectinib']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C1446165', 'cui_str': 'Immature reticulocyte fraction'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}]",,0.268989,"Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 % confidence interval [CI]:","[{'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2, Ohnohigashi, Osaka-sayama, Osaka 589-8511, Japan. Electronic address: nakagawa@med.kindai.ac.jp.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Hida', 'Affiliation': 'Department of Thoracic Oncology, Aichi Cancer Center, 1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan. Electronic address: 107974@aichi-cc.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. Electronic address: hnokihara@tokushima-u.ac.jp.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Morise', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65, Tsurumaicho, Nagoya Showa-ku, Aichi, 466-8550, Japan. Electronic address: morisem@med.nagoya-u.ac.jp.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Institution Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, 67 Asahi-machi, Kurume-shi, Fukuoka, 830-0011, Japan. Electronic address: azuma@med.kurume-u.ac.jp.'}, {'ForeName': 'Young Hak', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Respiratory Medicine, Kyoto University, 54 Shogoin-Kawaracho, Sakyo-ku, Kyoto 606-8507, Japan. Electronic address: ekim@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, 3-1-1 Notame, Minami-Ku, Fukuoka, 811-1395, Japan. Electronic address: setocruise@gmail.com.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. Electronic address: takiguchi@faculty.chiba-u.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto, Tokyo 135-8550, Japan. Electronic address: mnishio@jfcr.or.jp.'}, {'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Respiratory Medicine, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan. Electronic address: hgyoshioka@gmail.com.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kumagai', 'Affiliation': 'Department of Thoracic Oncology, Osaka International Cancer Institute, 3-1-69 Otemae Chuo-ku, Osaka 541-8567, Japan. Electronic address: torukumagai@ybb.ne.jp.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. Electronic address: khotta@md.okayama-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachidori, Chuouku, Niigata, 951-8510, Japan. Electronic address: satoshi7@med.niigata-u.ac.jp.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. Electronic address: kgoto@east.ncc.go.jp.'}, {'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Satouchi', 'Affiliation': 'Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, 13-70, Kitaoji-cho, Akashi, Hyogo, 673-8558, Japan. Electronic address: satouchi@hp.pref.hyogo.jp.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kozuki', 'Affiliation': 'Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-machi, Matsuyama City, Ehime Prefecture 791-0280, Japan. Electronic address: tokozuki@shikoku-cc.go.jp.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Koyama', 'Affiliation': 'Department of Respiratory Medicine, Juntendo University, 3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: rkoyama@juntendo.ac.jp.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Department of Surgery, Division of Thoracic Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, 377-2, Ohnohigashi, Osaka-sayama, Osaka 589-8511, Japan. Electronic address: mitsudom@med.kindai.ac.jp.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, 811-1, Kimiidera, Wakayama, 641-0012, Japan. Electronic address: nbyamamo@wakayama-med.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Asakawa', 'Affiliation': 'Clinical Information & Intelligence Department, Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-8324, Japan. Electronic address: asakawatks@chugai-pharm.co.jp.'}, {'ForeName': 'Morihiko', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Clinical Science & Strategy Department, Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-8324, Japan. Electronic address: hayashimrh@chugai-pharm.co.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Hasegawa', 'Affiliation': 'Clinical Science & Strategy Department, Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-8324, Japan. Electronic address: hasegawawkk@chugai-pharm.co.jp.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ""Thoracic Center, St. Luke's International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan. Electronic address: tamuratomohide@gmail.com.""}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.11.025'] 937,31765632,Stairways to the brain: Transcutaneous spinal direct current stimulation (tsDCS) modulates a cerebellar-cortical network enhancing verb recovery.,"It has long been assumed that the language function is hierarchically organized into specific cortical areas. Here, for the first time, we present direct evidence that the spinal cord takes part in language processing. In a randomized-double blind design, sixteen aphasics underwent a language treatment combined with transcutaneous spinal direct current stimulation (tsDCS). During the treatment, each subject received tsDCS (20 min, 2 mA) over the thoracic vertebrae (IX-X vertebrae) in two different conditions: (1) anodal, and (2) sham while performing a verb naming task. Each experimental condition was run in five consecutive daily sessions over two weeks. Before and after each condition, all patients underwent a resting state functional magnetic resonance imaging (rs-fMRI). After anodal tsDCS, significant functional connectivity changes were found in a cerebellar-cortical network recruiting regions such as the left cerebellum, the right parietal and premotor cortex known to be also involved in action-related verb processing. Indeed, this increase of connectivity significantly correlated with the greatest amount of improvement found in verb naming. In line with our experimental data, we also found a greater improvement after anodal tsDCS also on untreated items of the language test but only on tasks which required the use of verbs, such as verb naming and picture description. No significant changes were found in noun naming. Thus, this evidence emphasizes, for the first time, that the neural response due to tsDCS combined with language treatment changes during the course of recovery by enhancing activity into cortical regions which influence verb processing.",2020,No significant changes were found in noun naming.,[],"['brain: Transcutaneous spinal direct current stimulation (tsDCS', 'language treatment combined with transcutaneous spinal direct current stimulation (tsDCS', 'anodal, and (2) sham while performing a verb naming task']",['functional connectivity changes'],[],"[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0442831', 'cui_str': 'Direct current (physical force)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0447618,No significant changes were found in noun naming.,"[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Marangolo', 'Affiliation': 'Università Federico II, 80133, Naples, Italy; IRCCS, Fondazione Santa Lucia, 00179, Rome, Italy. Electronic address: paola.marangolo@gmail.com.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Fiori', 'Affiliation': 'IRCCS, Fondazione Santa Lucia, 00179, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'IRCCS, Fondazione Santa Lucia, 00179, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Incoccia', 'Affiliation': 'IRCCS, Fondazione Santa Lucia, 00179, Rome, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gili', 'Affiliation': 'IMT Scuola Alti Studi Lucca, 55100, Lucca, Italy. Electronic address: tommaso.gili@imtlucca.it.'}]",Brain research,['10.1016/j.brainres.2019.146564'] 938,31735618,"Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study.","INTRODUCTION Flibanserin is approved in the United States and Canada for the treatment of hypoactive sexual desire disorder in premenopausal women. AIM The purpose of this trial was to evaluate the safety of concomitant administration of flibanserin with alcohol. METHODS In this single-center, randomized, double-blind, single-dose, crossover study, participants were randomly assigned to 1 of 12 sequences to receive each of 7 treatments: flibanserin 100 mg or placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or flibanserin 100 mg only. Treatments were administered using a worst-case approach that included morning dosing and consumption of alcohol within 10 minutes. MAIN OUTCOME MEASURE The primary end point was the proportion of participants who experienced dizziness, syncope, or hypotension. Safety end points included orthostatic vital signs. RESULTS The study included 96 premenopausal women (mean age 31 ± 8 years). The incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol. Based on the available vital signs data, there was no effect of ethanol concentration on orthostatic blood pressure, vertigo, or hypotension; no instances of syncope were observed. The overall incidence of adverse events (AEs) was similar when flibanserin was administered alone (96.7%) or with ethanol (90.5-97.6%). CLINICAL IMPLICATIONS Consumption of the tested amounts of alcohol (0.2-0.6 g/kg) does not have an additive effect on the AE profile of flibanserin 100 mg in healthy premenopausal women. STRENGTHS & LIMITATIONS Strengths include the study population (premenopausal women, as indicated for flibanserin) and range of ethanol doses. Limitations include the morning dosing of study medication, which is inconsistent with the bedtime dosing recommended for flibanserin, and the method of handling missing vital sign measurements. CONCLUSION Co-administration of flibanserin 100 mg with varying doses of ethanol resulted in few AEs of special interest, with no notable alcohol dose response. However, a significantly greater percentage of participants administered flibanserin with 0.6 g/kg and 0.4 g/kg of alcohol were characterized as ""Participants in Whom Standing Blood Pressure Was Not Obtained"" compared with participants administered flibanserin alone. Simon JA, Clayton AH, Parish SJ, et al. Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. J Sex Med 2020;17:83-93.",2020,"The incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol.","['study population (premenopausal women, as indicated for flibanserin) and range of ethanol doses', '96 premenopausal women (mean age 31 ± 8 years', 'Healthy Premenopausal Women', 'hypoactive sexual desire disorder in premenopausal women', 'healthy premenopausal women']","['flibanserin 100 mg only', 'ethanol', 'flibanserin', 'Alcohol Administered With Flibanserin', 'flibanserin with alcohol', 'flibanserin 100 mg or placebo with ethanol', 'Flibanserin']","['orthostatic blood pressure, vertigo, or hypotension; no instances of syncope', 'proportion of participants who experienced dizziness, syncope, or hypotension', 'orthostatic vital signs', 'incidence of dizziness for ethanol\xa0+ flibanserin', 'overall incidence of adverse events (AEs']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020594', 'cui_str': 'Hypoactive Sexual Desire Disorder'}]","[{'cui': 'C4051422', 'cui_str': 'flibanserin 100 MG [Addyi]'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0518766'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.521132,"The incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University, Washington, DC, USA. Electronic address: jsimon@jamesasimonmd.com.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Parish', 'Affiliation': 'Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Stuart C', 'Initials': 'SC', 'LastName': 'Apfel', 'Affiliation': 'Albert Einstein College of Medicine, Yeshiva University, New York, New York, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Millheiser', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.004'] 939,31856945,Effects of smoking cessation treatment attendance on abstinence: The moderating role of psychologically based behavioral health conditions.,"Available smoking cessation treatments have shown only modest quit success. Presence of a psychologically based behavioral health condition (PBHC), such as depression, anxiety, or addiction, can impact smoking cessation treatment engagement and quit success; however, the differential effect of treatment engagement on smoking cessation outcomes across smokers with and without a PBHC is unknown. The current study examined the moderating effect presence (versus absence) of a PBHC on the relation between treatment attendance and early smoking abstinence following a 4-session smoking cessation treatment. Participants included 529 (45.9% male; Mage = 38.23 years, SD = 13.56; 75.4% White) smokers enrolled in a large randomized controlled trial evaluating the efficacy of a transdiagnostic smoking cessation treatment. A repeated-measures latent class analysis (RMLCA) was conducted to examine treatment attendance. The effects of treatment attendance, PBHC (present/absent), and their interaction were modeled on biochemically-verified point prevalence abstinence using a latent growth curve from 1-week to 1-month post-quit. The RMLCA provided evidence for three classes: Drop-outs (n = 197), Titrators (n = 89), and Completers (n = 243). A significant interaction emerged such that Completers without a PBHC were significantly more likely to be abstinent relative to Completers with a PBHC (b = 2.69, SE = 0.67, p < .001) and Titrators without a PBHC (b = 3.36, SE = 0.80, p < .001). These results provide novel data that implicate the clinical importance of treatment attendance and PBHC status on smoking abstinence.",2020,"A significant interaction emerged such that Completers without a PBHC were significantly more likely to be abstinent relative to Completers with a PBHC (b = 2.69, SE = 0.67, p < .001) and Titrators without a PBHC (b = 3.36, SE = 0.80, p < .001).","['Participants included 529 (45.9% male; Mage\u202f=\u202f38.23\u202fyears, SD\u202f=\u202f13.56; 75.4% White) smokers enrolled']","['transdiagnostic smoking cessation treatment', 'smoking cessation treatment attendance']",['abstinence'],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],529.0,0.0222721,"A significant interaction emerged such that Completers without a PBHC were significantly more likely to be abstinent relative to Completers with a PBHC (b = 2.69, SE = 0.67, p < .001) and Titrators without a PBHC (b = 3.36, SE = 0.80, p < .001).","[{'ForeName': 'Lorra', 'Initials': 'L', 'LastName': 'Garey', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Rogers', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Manning', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Smit', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jaye L', 'Initials': 'JL', 'LastName': 'Derrick', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Andres G', 'Initials': 'AG', 'LastName': 'Viana', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, United States of America.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America; HEALTH Institute, University of Houston, Houston, TX, United States of America. Electronic address: mjzvolen@central.uh.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.10.006'] 940,31747035,Augmentation of Positive Valence System-Focused Cognitive Behavioral Therapy by Inaudible High-Frequency Sounds for Anhedonia: A Trial Protocol for a Pilot Study.,"Importance Recent conceptualizations in Research Domain Criteria have indicated that anhedonia, 1 of 2 core symptoms of depression, which can be treatment resistant, is associated with deficits in the positive valence system, and inaudible high-frequency sound therapy has been shown to enhance reward-related brain circuitry. Hence, cognitive behavioral therapy focusing on the positive valence system enhanced with sound therapy could have a synergistic effect on anhedonia. Objective To test the augmentation effect of inaudible high-frequency sounds on the efficacy of positive valence system-focused cognitive behavioral therapy to treat anhedonia. Design, Setting, and Participants In this individual-level allocation, exploratory, single-center randomized superiority pilot trial, patients, therapists, and evaluators will be masked to intervention or placebo assignment. The trial will take place at a national psychiatric referral hospital in Tokyo, Japan, among 44 adult patients with clinically significant anhedonia and moderate to severe depression. Outcomes will be analyzed following the intent-to-treat principle using a repeated-measures mixed model. Intervention The intervention group will participate in 8 weekly sessions of positive valence system-focused cognitive behavioral therapy with in-session exposure to an inaudible high-frequency sound; the comparison group will undergo cognitive behavioral therapy with in-session exposure to a placebo sound. Main Outcomes and Measures The primary outcome is anhedonia assessed using the self-reported Snaith-Hamilton Pleasure Scale. The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale. Discussion Recruitment for this study began in May 2018, and the projected date of final allocation is January 2020. A total of 21 eligible patients were registered for participation as of May 30, 2019. To date, treatments for depression do not guarantee clinically successful outcomes. This pilot trial will provide preliminary evidence of the augmentation effect of high-frequency inaudible sounds on cognitive behavioral therapy for anhedonia. Overall, exposure to an inaudible high-frequency sounds does not require attentional or cognitive effort from either patients or therapists; therefore, results from a future confirmative trial could indicate that cognitive behavioral therapy can be augmented in an effortless manner. Trial Registration umin.ac.jp/ctr Identifier: UMIN000031948.",2019,"The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale. ","['44 adult patients with clinically significant anhedonia and moderate to severe depression', 'Anhedonia', '21 eligible patients were registered for participation as of May 30, 2019']","['Positive Valence System', 'positive valence system-focused cognitive behavioral therapy with in-session exposure to an inaudible high-frequency sound; the comparison group will undergo cognitive behavioral therapy with in-session exposure to a placebo sound', 'Focused Cognitive Behavioral Therapy', 'positive valence system-focused cognitive behavioral therapy']","['anhedonia assessed using the self-reported Snaith-Hamilton Pleasure Scale', 'anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0222045'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",44.0,0.0992092,"The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale. ","[{'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Miyamae', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Yokoyama', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Information Medicine, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ueno', 'Affiliation': 'Department of Information Medicine, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Maruo', 'Affiliation': 'University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Komazawa', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Niwa', 'Affiliation': 'National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Honda', 'Affiliation': 'Department of Information Medicine, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Horikoshi', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.15819'] 941,31059991,Efficacy of repetitive transcranial magnetic stimulation using a figure-8-coil or an H1-Coil in treatment of major depressive disorder; A randomized clinical trial.,"Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based treatment option for major depressive disorder (MDD). However, comparisons of efficacy between the two FDA-approved protocols of rTMS modalities are lacking. The aim of this industry-independent, randomized-controlled, single-blind trial was to evaluate clinical outcome of the two FDA-approved rTMS protocols delivered by H1-coil and the figure-8-coil, in MDD patients. A total of 228 MDD patients were randomized to 20 sessions of H1-coil or 8-coil as an adjunct to standard-of-care pharmacotherapy, or standard-of-care pharmacotherapy alone. Baseline MDD symptom severity was almost the same in the three groups. Hamilton depression rating scale (HAM-D17) mean score was 17 (5.3) in H1-coil, 17 (5.4) in 8-coil, and 19 (6.1) in control group. The primary outcome was the proportion of patients achieving remission defined as HAM-D17 score ≤7 at end-of-treatment at week-4. In the intention-to-treat analysis odds ratio for remission was 1.74 (CI95% 0.79-3.83) in H1-coil compared to the 8-coil group. The difference between two rTMS protocols was not significant. Remission rate was significantly greater in both HF-rTMS groups compared to the control: 60% (CI95% 48-71%), 43% (CI95% 31-55%) and 11% (CI95% 5-20%) respectively. The response was significantly better in H1-coil, than in 8-coil group OR = 2.33; CI95% 1.04-5.21 (P = 0.040). The HAM-D17 was lowered by 59% in the H1-coil, 41% in the 8-coil (P = 0.048), and 17% in the control group (P < 0.001 vs H1-coil; P = 0.003 vs 8-coil). Safety, tolerability, and the changes in quality of life were comparable. We confirmed the safety and efficacy of both FDA-approved protocols as adjunctive treatments of MDD. Better response rate and greater reduction of depression severity were observed in the H1-coil group, but without a significant difference in the remission rate between the two rTMS modalities. CLINICAL TRIALS REGISTRATION: Clinicaltrials.govNCT02917499.",2019,In the intention-to-treat analysis odds ratio for remission was 1.74 (CI95% 0.79-3.83) in H1-coil compared to the 8-coil group.,"['MDD patients', 'major depressive disorder', 'major depressive disorder (MDD', '228 MDD patients']","['repetitive transcranial magnetic stimulation', 'HF-rTMS', 'H1-coil or 8-coil as an adjunct to standard-of-care pharmacotherapy, or standard-of-care pharmacotherapy alone', 'Repetitive transcranial magnetic stimulation (rTMS']","['safety and efficacy', 'Hamilton depression rating scale (HAM-D17) mean score', 'depression severity', 'Baseline MDD symptom severity', 'remission rate', 'HAM-D17', 'Safety, tolerability', 'quality of life', 'Remission rate', 'proportion of patients achieving remission defined as HAM-D17 score ≤7']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",228.0,0.041933,In the intention-to-treat analysis odds ratio for remission was 1.74 (CI95% 0.79-3.83) in H1-coil compared to the 8-coil group.,"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Filipčić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Zagreb, Croatia; Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia. Electronic address: igor.filipcic@pbsvi.hr.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Šimunović Filipčić', 'Affiliation': 'Department of Psychological Medicine, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Milovac', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Zagreb, Croatia.'}, {'ForeName': 'Strahimir', 'Initials': 'S', 'LastName': 'Sučić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Gajšak', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Zagreb, Croatia.'}, {'ForeName': 'Ena', 'Initials': 'E', 'LastName': 'Ivezić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Zagreb, Croatia; Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Bašić', 'Affiliation': 'Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia; Department of Neurology, Dubrava University Hospital, Zagreb, Croatia.'}, {'ForeName': 'Žarko', 'Initials': 'Ž', 'LastName': 'Bajić', 'Affiliation': 'Psychiatric Hospital ""Sveti Ivan"", Zagreb, Croatia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.020'] 942,30782512,Effect of lurasidone vs olanzapine on neurotrophic biomarkers in unmedicated schizophrenia: A randomized controlled trial.,"Neurotrophic factors like Brain-Derived Neurotrophic Factor (BDNF), Neurotrophin 3 (NT3) and Nerve Growth Factor (NGF), play a role in neuroplasticity and neurogenesis contributing to the pathogenesis of schizophrenia. The objective of the present study was to investigate and compare the effect of olanzapine and lurasidone on the change in serum neurotrophins in patients with schizophrenia. The present study was a randomized, open-label, active-controlled, parallel design clinical trial. After randomization baseline evaluations of serum BDNF, NGF, NT3, Positive and Negative Syndrome Scale (PANSS) scoring, Social and Occupational Functioning Assessment Scale (SOFAS) scoring of 101 unmedicated schizophrenia patients were done. Patients were reassessed after 6 weeks of monotherapy with olanzapine or lurasidone. Serum BDNF increased after treatment with both the drug groups but rise with olanzapine was found to be significantly higher (916.22; 95 %CI: 866.07 to 966.37; p < 0.001) in comparison to lurasidone. Increase in levels NGF and NT3 was also observed but there was no significant difference between the groups (NGF: 2.32; CI: 3.54 to -3.53; p = 0.57 and NT3: 0.99; CI: 2.11 to 0.14; p = 0.086). The difference in improvement in PANSS and SOFASS with both the drugs was not statistically significant. Both the drugs alleviate the symptoms of schizophrenia but olanzapine was better tolerated. Our findings suggest that increase in serum BDNF with olanzapine monotherapy is significantly higher than that with lurasidone but there is no significant difference in change in serum NGF and NT3. TRIAL REGISTRATION: ClinicalTrials.gov identifier: (NCT03304457).",2019,Increase in levels NGF and NT3 was also observed but there was no significant difference between the groups (NGF: 2.32; CI: 3.54 to -3.53; p = 0.57 and NT3: 0.99; CI: 2.11 to 0.14; p = 0.086).,"['unmedicated schizophrenia', '101 unmedicated schizophrenia patients', 'patients with schizophrenia']","['olanzapine or lurasidone', 'lurasidone vs olanzapine', 'olanzapine monotherapy', 'olanzapine', 'olanzapine and lurasidone']","['serum BDNF', 'Serum BDNF', 'neurotrophic biomarkers', 'serum BDNF, NGF, NT3, Positive and Negative Syndrome Scale (PANSS) scoring, Social and Occupational Functioning Assessment Scale (SOFAS', 'levels NGF and NT3', 'PANSS and SOFASS', 'serum NGF and NT3']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C4704801', 'cui_str': 'Neurotrophic'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",101.0,0.0490748,Increase in levels NGF and NT3 was also observed but there was no significant difference between the groups (NGF: 2.32; CI: 3.54 to -3.53; p = 0.57 and NT3: 0.99; CI: 2.11 to 0.14; p = 0.086).,"[{'ForeName': 'Monalisa', 'Initials': 'M', 'LastName': 'Jena', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. Electronic address: pharm_monalisa@aiimsbhubaneswar.edu.in.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Ranjan', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Patna, India. Electronic address: rajeevranjan0087@gmail.com.'}, {'ForeName': 'Biswa Ranjan', 'Initials': 'BR', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. Electronic address: brm1678@gmail.com.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, KIMS, Bhubaneswar, India. Electronic address: archanapmv@gmail.com.'}, {'ForeName': 'Santanu', 'Initials': 'S', 'LastName': 'Nath', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. Electronic address: beta.santanu@gmail.com.'}, {'ForeName': 'Pallabi', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Psychiatry, KIMS, Bhubaneswar, India. Electronic address: pallabisamir@yahoo.com.'}, {'ForeName': 'Bikash Ranjan', 'Initials': 'BR', 'LastName': 'Meher', 'Affiliation': 'Department of Psychiatry, KIMS, Bhubaneswar, India. Electronic address: pharm_bikash@aiimsbhubaneswar.edu.in.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. Electronic address: pharm_anand@aiimsbhubaneswar.edu.in.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Maiti', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. Electronic address: pharm_rituparna@aiimsbhubaneswar.edu.in.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.02.007'] 943,31837624,Manualized cognitive behavioral group therapy to treat vasomotor symptoms for women diagnosed with mood disorders.,"OBJECTIVE This 6-week, prospective, single-arm study examined the feasibility, acceptability, and preliminary efficacy of cognitive behavioral group therapy in peri- and postmenopausal women with mood disorders (major depression or bipolar) and problematic vasomotor menopausal symptoms. METHODS 59 participants from an outpatient clinic with mood disorders and problematic vasomotor symptoms were enrolled. The primary outcomes were change from baseline to 6 weeks in Hot Flush Night Sweat Problem Rating, Hot Flash Related Daily Interference, and Quality of Life. Secondary outcomes were change in Hot Flush Frequency, depression, anxiety, perceived stress, anhedonia, beliefs and cognitive appraisals of menopause. ClinicalTrials.gov [identifier: NCT02860910]. RESULTS On the Hot Flush Night Sweat Problem Rating, 39.3% improved 2 or more points, which was clinically relevant. Changes in Quality of Life (p = .001) and the Hot Flash Related Daily Interference Scale were also significant (p < .001). Significant results were found on most secondary outcomes (hot flush frequency on the Hot Flush Daily Diary, depression, anxiety, perceived stress (p < .001) and anhedonia (p = .001). One of six subscales (control subscale) on the cognitive appraisal of menopause significantly improved (p < .001). Three subscales on the beliefs measure did not change significantly (p = .05, p = .91, and p = .14). Six-week study retention was robust (N = 55, 93%) and 94.2% of individuals reported that cognitive behavioral group therapy sessions were useful. CONCLUSION This exploratory study suggests that CBGT is acceptable, feasible, and efficacious in women with mood disorders and problematic menopause vasomotor symptoms. Further studies are needed using more rigorous and controlled methods.",2020,Changes in Quality of Life (p = .001) and the Hot Flash Related Daily Interference Scale were also significant (p < .001).,"['peri- and postmenopausal women with mood disorders (major depression or bipolar) and problematic vasomotor menopausal symptoms', 'women with mood disorders and problematic menopause vasomotor symptoms', '59 participants from an outpatient clinic with mood disorders and problematic vasomotor symptoms were enrolled', 'women diagnosed with mood disorders']","['Manualized cognitive behavioral group therapy', 'CBGT', 'cognitive behavioral group therapy']","['anhedonia', 'change in Hot Flush Frequency, depression, anxiety, perceived stress, anhedonia, beliefs and cognitive appraisals of menopause', 'Quality of Life', 'cognitive appraisal of menopause', 'Hot Flush Daily Diary, depression, anxiety, perceived stress', 'Hot Flash Related Daily Interference Scale', 'Hot Flush Night Sweat Problem Rating, Hot Flash Related Daily Interference, and Quality of Life']","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0028081', 'cui_str': 'Night sweats (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",59.0,0.0558083,Changes in Quality of Life (p = .001) and the Hot Flash Related Daily Interference Scale were also significant (p < .001).,"[{'ForeName': 'Danette Y', 'Initials': 'DY', 'LastName': 'Conklin', 'Affiliation': 'Department of Psychiatry and Reproductive Biology, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: Danette.Conklin@UHhospitals.org.'}, {'ForeName': 'Toyomi', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Center for Value-based Care Research, Cleveland Clinic Foundation, Cleveland, OH, USA. Electronic address: gotot@ccf.org.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ganocy', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA. Electronic address: sjg18@case.edu.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Loue', 'Affiliation': 'Departments of Bioethics, Epidemiology and Biostatics, Psychiatry, and Global Health, Case Western Reserve University School of Medicine, Cleveland, OH, USA. Electronic address: sxl54@case.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'LaGrotta', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai-SLW, New York, NY, USA. Electronic address: Christine.lagrotta@va.gov.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Delozier', 'Affiliation': 'Clinical Research Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: Sarah.Delozier@UHhospitals.org.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Brownrigg', 'Affiliation': 'Mood Disorders Research Program, University Hospitals Cleveland Medical Center, Department of Psychiatry, Cleveland, OH, USA. Electronic address: Brittany.Brownrigg@UHhospitals.org.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Conroy', 'Affiliation': 'Mood Disorders Program, Intervention and Services Research Center, University Hospitals Cleveland Medical Center, Department of Psychiatry, Cleveland, OH, USA. Electronic address: Carla.Conroy@UHhospitals.org.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': ""D'Arcangelo"", 'Affiliation': 'University Hospitals Cleveland Medical Center, Department of Psychiatry, Cleveland, OH, USA. Electronic address: nicole.darcangelo@averydennison.com.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Janes', 'Affiliation': 'Clinical Research Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: Jessica.Janes@UHhospitals.org.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Ogede', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA. Electronic address: doo6@case.edu.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: Martha.Sajatovic@UHhospitals.org.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109882'] 944,31866327,Adverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trials.,"BACKGROUND An important problem limiting treatment of latent tuberculosis infection is the occurrence of adverse events with isoniazid. We combined populations from phase 2 and phase 3 open-label, randomised controlled trials, to establish risk factors for adverse events during latent tuberculosis infection treatment. METHODS We did a post-hoc safety analysis based on data from two open-label, randomised controlled trials done in health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea. Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to rifampicin or isoniazid. Patients were centrally randomly assigned 1:1 to 4 months of daily 10 mg/kg rifampicin or 9 months of daily 5 mg/kg isoniazid. The primary outcome evaluated was adverse events (including grade 1-2 rash and all events of grade 3-5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug by a masked, independent, three-member adjudication panel (trial registration: NCT00170209; NCT00931736). FINDINGS Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3). The safety populations for each group comprised 3205 individuals receiving isoniazid and 3280 receiving rifampicin. Among those receiving isoniazid, 86 (2·7%) of 3205 had grade 1-2 rash or any grade 3-5 adverse events, more than the 50 (1·5%) of 3280 who had these events with rifampicin (risk difference -1·2%, 95% CI -1·9 to -0·5). Age was associated with adverse events in adults receiving isoniazid. Compared with individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years. With rifampicin, adverse events were associated with inconsistent medication adherence (adjusted OR 2·0, 1·1-3·6) and concomitant medication use (2·8, 1·5-5·2), but not age, with an adjusted OR of 1·1 (0·6-2·1) for individuals aged 35-64 years and 1·7 (0·5-4·7) for individuals aged 65-90 years. One treatment-related death occurred in the isoniazid group. INTERPRETATION In patients without a contraindication, rifampicin is likely to be the safest latent tuberculosis infection treatment option. With more widespread use of rifampicin, rare, but serious adverse events might be seen. However, within these randomised trials, rifampicin was safer than isoniazid and adverse events were not associated with older age. Therefore, rifampicin should become a primary treatment option for latent tuberculosis infection based on its safety. FUNDING Canadian Institutes of Health Research.",2020,"Compared with individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years.","['adults with latent tuberculosis infection receiving daily', 'health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea', '3205 individuals receiving', 'Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3', 'Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to', 'individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years']","['rifampicin or 9 months of daily 5 mg/kg isoniazid', 'rifampicin', 'isoniazid', 'rifampicin or isoniazid']","['grade 1-2 rash or any grade 3-5 adverse events', 'death', 'adverse events (including grade 1-2 rash and all events of grade 3-5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug', 'adverse events', 'Adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1609538', 'cui_str': 'Latent Tuberculosis Infection'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0005005', 'cui_str': 'Dahomey'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0018381', 'cui_str': 'Guinea, Republic of'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0086143'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0221191', 'cui_str': 'Judge (occupation)'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",,0.176653,"Compared with individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years.","[{'ForeName': 'Jonathon R', 'Initials': 'JR', 'LastName': 'Campbell', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Anete', 'Initials': 'A', 'LastName': 'Trajman', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Cook', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada; Provincial TB Services, British Columbia Centre for Disease Control, Vancouver, BC, Canada.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Johnston', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada; Provincial TB Services, British Columbia Centre for Disease Control, Vancouver, BC, Canada.'}, {'ForeName': 'Menonli', 'Initials': 'M', 'LastName': 'Adjobimey', 'Affiliation': 'National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin.'}, {'ForeName': 'Rovina', 'Initials': 'R', 'LastName': 'Ruslami', 'Affiliation': 'Department of Biomedical Sciences, Division of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eisenbeis', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fregonese', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Valiquette', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montréal, QC, Canada. Electronic address: dick.menzies@mcgill.ca.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30575-4'] 945,31866328,"Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial.","BACKGROUND Treatment of ventilated pneumonia is often unsuccessful, even when patients are treated according to established guidelines. Therefore, we aimed to investigate the efficacy of the combination drug device Amikacin Inhale as an adjunctive therapy to intravenous standard-of-care antibiotics for pneumonia caused by Gram-negative pathogens in intubated and mechanically ventilated patients. METHODS INHALE was a prospective, double-blind, randomised, placebo-controlled, phase 3 study comprising two trials (INHALE 1 and INHALE 2) done in 153 hospital intensive-care units in 25 countries. Eligible patients were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was documented as being caused by or showing two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6. Patients were stratified by region and disease severity (according to their Acute Physiology and Chronic Health Evaluation [APACHE] II score) and randomly assigned (1:1) via an interactive voice-recognition system to receive 400 mg amikacin (Amikacin Inhale) or saline placebo, both of which were aerosolised, administered every 12 h for 10 days via the same synchronised inhalation system, and given alongside standard-of-care intravenous antibiotics. All patients and all staff involved in administering devices and monitoring outcomes were masked to treatment assignment. The primary endpoint, survival at days 28-32, was analysed in all patients who received at least one dose of study drug, were infected with a Gram-negative pathogen, and had an APACHE II score of at least 10 at diagnosis. Safety analyses were done in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, numbers NCT01799993 and NCT00805168. FINDINGS Between April 13, 2013, and April 7, 2017, 807 patients were assessed for eligibility and 725 were randomly assigned to Amikacin Inhale (362 patients) or aerosolised placebo (363 patients). 712 patients received at least one dose of study drug (354 in the Amikacin Inhale group and 358 in the placebo group), although one patient assigned to Amikacin Inhale received placebo in error and was included in the placebo group for safety analyses. 508 patients (255 in the Amikacin Inhale group and 253 in the placebo group) were assessed for the primary endpoint. We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43). Similar proportions of patients in the two treatment groups had a treatment-emergent adverse event (295 [84%] of 353 patients in the Amikacin Inhale group vs 303 [84%] of 359 patients in the placebo group) or a serious treatment-emergent adverse event (101 [29%] patients vs 97 [27%] patients). INTERPRETATION Our findings do not support use of inhaled amikacin adjunctive to standard-of-care intravenous therapy in mechanically ventilated patients with Gram-negative pneumonia. FUNDING Bayer AG.",2020,"We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43).","['153 hospital intensive-care units in 25 countries', 'mechanically ventilated patients with Gram-negative pneumonia (INHALE', 'Eligible patients were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was documented as being caused by or showing two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6', 'Between April 13, 2013, and April 7, 2017, 807 patients were assessed for eligibility and 725 were randomly assigned to', '508 patients (255 in the Amikacin Inhale group and 253 in the', 'intubated and mechanically ventilated patients', 'mechanically ventilated patients with Gram-negative pneumonia', 'Patients were stratified by region and disease severity (according to their Acute Physiology and Chronic Health Evaluation [APACHE] II score) and randomly assigned (1:1) via an', '363 patients', '712 patients received at least one dose of study drug (354 in the Amikacin Inhale group and 358 in the']","['amikacin adjunctive to intravenous standard-of-care antibiotics', 'placebo', 'Amikacin Inhale received placebo', 'amikacin adjunctive', 'aerosolised placebo', 'interactive voice-recognition system to receive 400 mg amikacin (Amikacin Inhale) or saline placebo', 'Amikacin']","['survival', 'serious treatment-emergent adverse event', 'treatment-emergent adverse event']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0854248', 'cui_str': 'Pneumonia caused by Gram negative bacteria (disorder)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",807.0,0.74974,"We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43).","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Niederman', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, New York Presbyterian/Weill Cornell Medical Center, New York, NY, USA. Electronic address: msn9004@med.cornell.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Alder', 'Affiliation': 'Anti-Infective Consulting, Margaretville, NY, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bassetti', 'Affiliation': 'Infectious Diseases Clinic, Department of Health Sciences, University of Genoa and Policlinico San Martino Hospital, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Boateng', 'Affiliation': 'Bayer Healthcare Inc, Whippany, NJ, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Corkery', 'Affiliation': 'Novartis Pharmaceuticals, San Carlos, CA, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Dhand', 'Affiliation': 'Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lawatscheck', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McLeroth', 'Affiliation': 'Covance, Princeton, NJ, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Nicolau', 'Affiliation': 'Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'G Christopher', 'Initials': 'GC', 'LastName': 'Wood', 'Affiliation': 'Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, University of Tennessee, Memphis, TN, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Chastre', 'Affiliation': 'Intensive Care Unit, Sorbonne University Hospitals, Paris, France.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30574-2'] 946,31888378,Laboratory Findings After Urinary Tract Infection and Antimicrobial Prophylaxis in Children With Vesicoureteral Reflux.,"It is a common practice to monitor blood tests in patients receiving long-term trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis for recurrent urinary tract infections. This multicenter, randomized, placebo-controlled trial enrolled 607 children aged 2 to 71 months with vesicoureteral reflux diagnosed after symptomatic urinary tract infection. Study participants received TMP-SMZ (n = 302) or placebo (n = 305) and were followed for 2 years. Serum electrolytes (n ≥ 370), creatinine (n = 310), and complete blood counts (n ≥ 206) were measured at study entry and at the 24-month study conclusion. We found no significant electrolyte, renal, or hematologic abnormalities when comparing the treatment and placebo groups. We observed changes in several laboratory parameters in both treatment and placebo groups as would normally be expected with physiologic maturation. Changes were within the normal range for age. Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine. Our findings do not support routine monitoring of these laboratory tests in children receiving long-term TMP-SMZ prophylaxis.",2020,"Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine.","['patients receiving long-term', 'Children With Vesicoureteral Reflux', 'children receiving long-term TMP-SMZ prophylaxis', '607 children aged 2 to 71 months with vesicoureteral reflux diagnosed after symptomatic urinary tract infection']","['placebo', 'TMP-SMX', 'trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis', 'TMP-SMZ']","['Serum electrolytes (n ≥ 370), creatinine (n = 310), and complete blood counts (n ≥ 206', 'complete blood count, serum electrolytes, or creatinine', 'significant electrolyte, renal, or hematologic abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteral Reflux'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",607.0,0.253822,"Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine.","[{'ForeName': 'Milan Dattaram', 'Initials': 'MD', 'LastName': 'Nadkarni', 'Affiliation': 'Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Tej K', 'Initials': 'TK', 'LastName': 'Mattoo', 'Affiliation': ""Children's Hospital of Michigan, Detroit, MI, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gravens-Mueller', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Myra A', 'Initials': 'MA', 'LastName': 'Carpenter', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marva', 'Initials': 'M', 'LastName': 'Moxey-Mims', 'Affiliation': ""Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Saul P', 'Initials': 'SP', 'LastName': 'Greenfield', 'Affiliation': 'State University of New York at Buffalo, NY, USA.'}, {'ForeName': 'Ranjiv', 'Initials': 'R', 'LastName': 'Mathews', 'Affiliation': 'Southern Illinois University, Springfield, IL, USA.'}]",Clinical pediatrics,['10.1177/0009922819898185'] 947,31852312,"Complex Wound Healing Outcomes for Outpatients Receiving Care via Telemedicine, Home Health, or Wound Clinic: A Randomized Controlled Trial.","Use of telemedicine has expanded rapidly in recent years, yet there are few comparative studies to determine its effectiveness in wound care. To provide experimental data in the field of telemedicine with regard to wound care, a pilot project named ""Domoplaies"" was publicly funded in France in 2011. A randomized, controlled trial was performed to measure the outcomes of patients with complex wounds who received home wound care from a local clinician guided by an off-site wound care expert via telemedicine, versus patients who received in-home or wound clinic visits with wound care professionals. The publicly funded network of nurses and physicians highly experienced in wound healing was used to provide wound care recommendations via telemedicine for the study. The healing rate at 6 months was slightly better for patients who received wound care via telemedicine (61/89; 68.5%) versus wound care professional at home (38/59; 64.4%) versus wound care clinic (22/35; 62.9%), but the difference was not significant ( P = .860833). The average time to healing for the 121/183 wounds that healed within 6 months was 66.8 ± 32.8 days for the telemedicine group, 69.3 ± 26.7 for the wound care professional at home group, and 55.8 ± 25.0 days for the wound care clinic group. Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P < .01). Telemedicine performed by wound healing clinicians working in a network setting offered a safe option to remotely manage comorbid, complex wound care patients with reduced mobility.",2020,"Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P < .01).","['Outpatients', 'patients with complex wounds who received home wound care from a local clinician guided by an off-site wound care expert via telemedicine, versus patients who received in-home or wound clinic visits with wound care professionals']","['telemedicine', 'Receiving Care via Telemedicine, Home Health, or Wound Clinic', 'Telemedicine']","['average time to healing', 'Transportation costs', 'death rate', 'Complex Wound Healing Outcomes', 'healing rate']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]",,0.0417822,"Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P < .01).","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Téot', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Geri', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lano', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Cabrol', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Linet', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Mercier', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}]",The international journal of lower extremity wounds,['10.1177/1534734619894485'] 948,31849356,Comparison of single-layer continues or two-layer interrupted pancreatojejunal suture in Frey procedure for treatment of chronic pancreatitis: a prospective randomized study.,"BACKGROUND Many patients with chronic pancreatitis are elected for surgery when endoscopic interventions are ineffective. Duodenum preserving pancreatic head resection introduced by Charles F. Frey is the most common procedure used for surgical treatment of chronic pancreatitis. However, technical aspects of this procedure have not been studied extensively. Goal Our prospective randomized study is aimed to compare usage of single-layer continuous (I group) and two-layer interrupted sutures (II group) in constructing pancreatojejunostomy after Frey procedure. METHODS AND MATERIALS In a period between 2009 and 2016, a total of 103 patients, diagnosed with chronic pancreatitis and determined medical indications for surgical treatment were included into the study and randomized into group I (52 patients) and group II (51 patients). Preoperative, intraoperative patient characteristics and postoperative results were compared between both groups. RESULTS Mean duration of surgery was statistically shorter in group I - 210 min, while in group II - 240 min (p = 0.004). Pancreatojejunoanastomosis construction time was shorter in group I - 19 (±6) min versus 51 (±18) min in group II, p <0,001. No statistically relevant differences were observed in postoperative morbidity: group I - 51.9% and group II - 45,1% (p = 0.177) and mortality: group I - 3.8% and group II - 2% (p = 0.636). CONCLUSIONS Frey procedure using single-layer continuous pancreatojejunostomy is safe, fast and less complex method in surgical treatment of chronic pancreatitis.",2019,"No statistically relevant differences were observed in postoperative morbidity: group I - 51.9% and group II - 45,1% (p = 0.177) and mortality: group I - 3.8% and group II - 2% (p = 0.636). ","['patients with chronic pancreatitis', '103 patients, diagnosed with chronic pancreatitis and determined medical indications for surgical treatment', 'chronic pancreatitis']","['single-layer continuous (I group) and two-layer interrupted sutures', 'single-layer continues or two-layer interrupted pancreatojejunal suture in Frey procedure']","['Pancreatojejunoanastomosis construction time', 'Mean duration of surgery', 'postoperative morbidity', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",103.0,0.0307304,"No statistically relevant differences were observed in postoperative morbidity: group I - 51.9% and group II - 45,1% (p = 0.177) and mortality: group I - 3.8% and group II - 2% (p = 0.636). ","[{'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Šileikis', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Jurevičius', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Mykolas', 'Initials': 'M', 'LastName': 'Butvila', 'Affiliation': 'Vilnius University, Faculty of Medicine, Vilnius, Lithuania.'}, {'ForeName': 'Kęstutis', 'Initials': 'K', 'LastName': 'Strupas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}]",Polski przeglad chirurgiczny,['10.5604/01.3001.0013.5381'] 949,32108732,Interferential current: a new option for the treatment of sexual complaints in women with premature ovarian insufficiency using systemic hormone therapy: a randomized clinical trial.,"OBJECTIVE The aim of the study was to evaluate the efficacy of interferential current (IC) in the sexual function of women with premature ovarian insufficiency (POI) using systemic hormone therapy (HT), compared to topical estriol. METHODS A randomized clinical trial with 40 women with POI using systemic HT, who were sexually active and referred for dyspareunia and reduction of lubrication. The women were divided into two treatment groups for 4 weeks: IC group (eight electrotherapy sessions twice a week); or E group (estriol vaginal cream, daily application, 0.5 mg/d). The Female Sexual Function Index was used to evaluate pre-/posttreatment sexual function. RESULTS Mean age was 37.13 ± 7.27 years and mean treatment time with HT was 8.20 ± 8.73 years, similar data for both groups. There was an improvement in global sexual function, lubrication, and pain domains for both treatments. The differences between the pre-/posttreatment lubrication scores were respectively 0.75 ± 3.31 (P = 0.014) for IC and 1.16 ± 1.22 (P < 0.001) for estriol, whereas for dyspareunia the differences were 1.00 ± 1.47 (P = 0.005) for IC, and 0.68 ± 1.30 (P = 0.006) for estriol. There was no pre-/posttreatment difference for the desire and arousal domains. Only in the IC group did orgasm (difference 0.90 ± 1.42, P = 0.010) and satisfaction improve (difference 0.70 ± 1.28, P = 0.021). CONCLUSION The use of perineal IC seems to be a new option for women with POI using systemic HT and presenting with sexual complaints, leading to an improvement in pain, lubrication, satisfaction, and orgasm.",2020,"Only in the IC group did orgasm (difference 0.90 ± 1.42, P = 0.010) and satisfaction improve (","['40 women with POI using systemic HT, who were sexually active and referred for dyspareunia and reduction of lubrication', 'women with POI using systemic HT and presenting with sexual complaints', 'women with premature ovarian insufficiency (POI', 'Mean age was 37.13\u200a±\u200a7.27 years and mean treatment time with HT was 8.20\u200a±\u200a8.73 years, similar data for both groups', 'women with premature ovarian insufficiency using']","['systemic hormone therapy (HT', 'interferential current (IC', 'IC group (eight electrotherapy sessions twice a week); or E group (estriol vaginal cream, daily application, 0.5\u200amg/d', 'systemic hormone therapy', 'Interferential current', 'topical estriol']","['pre-/posttreatment lubrication scores', 'satisfaction improve ', 'global sexual function, lubrication, and pain domains', 'desire and arousal domains']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443045', 'cui_str': 'Poi (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1318469', 'cui_str': 'Lubrication'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C1251931', 'cui_str': 'Estriol Vaginal Cream'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0014927', 'cui_str': 'Estriol'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1318469', 'cui_str': 'Lubrication'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",40.0,0.107765,"Only in the IC group did orgasm (difference 0.90 ± 1.42, P = 0.010) and satisfaction improve (","[{'ForeName': 'Cristina L', 'Initials': 'CL', 'LastName': 'Benetti-Pinto', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, UNICAMP, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Helena P', 'Initials': 'HP', 'LastName': 'Giraldo', 'Affiliation': ''}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Giraldo', 'Affiliation': ''}, {'ForeName': 'Ticiana A', 'Initials': 'TA', 'LastName': 'Mira', 'Affiliation': ''}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Yela', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001501'] 950,31253485,Topical estradiol increases epidermal thickness and dermal collagen of foreskin prior to hypospadia surgery - Randomized double blinded controlled trial.,"INTRODUCTION The use of preoperative topical testosterone stimulation prior to hypospadias correction aims to increase penile size and achieve better surgical results. Topical estradiol has been shown to improve the quality of skin in other sites, but its use in boys with hypospadia has not yet been elucidated. OBJECTIVE This study aims to evaluate the primary effects in epidermal thickness and collagen distribution of estradiol compared to testosterone and placebo in skin of prepuce before hypospadia surgery. MATHERIALS AND METHODS Patients were randomized into three groups according to the topical hormone used: TG: Testosterone ointment; EG: Estradiol ointment; CG: Neutral base ointment. Fragments of foreskin were excised, fixed and then sectioned for histology. For each sample, epidermal thickness and dermal collagen expression was measured by specific computer analysis, P-values of <0.05. RESULTS Thirty-three patients with a mean age of 4.01 ± 2.92 years were included. Hypospadia classification was similar in all three groups. Mean epidermal thickness and collagen type I expression in EG were greater than those of the other groups. Collagen type III expression was similar in all groups. DISCUSSION Foreskin has a fundamental role in many techniques of hypospadias surgery and can be used either as a graft or a flap in the correction of the penile defect. Increase of epidermal thickness and dermal collagen observed in the present study has already been related to use of estradiol in other skin sites, but not yet in foreskin. Further studies are needed to evaluate the real significance of these findings in boys with hypospadias. CONCLUSION Use of topical estradiol before hypospadias surgery lead to greater epidermal thickness and increases dermal collagen expression in foreskin.",2019,Mean epidermal thickness and collagen type I expression in EG were greater than those of the other groups.,"['Thirty-three patients with a mean age of 4.01\xa0±\xa02.92 years were included', 'skin of prepuce before hypospadia surgery', 'Patients', 'boys with hypospadias']","['topical hormone used: TG', 'Topical estradiol', 'testosterone and placebo', 'topical estradiol', 'Testosterone ointment; EG: Estradiol ointment; CG', 'preoperative topical testosterone stimulation prior to hypospadias correction']","['epidermal thickness and dermal collagen expression', 'Hypospadia classification', 'Mean epidermal thickness and collagen type I expression in EG', 'Collagen type III expression', 'epidermal thickness and dermal collagen', 'dermal collagen expression', 'epidermal thickness and dermal collagen of foreskin']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0222196', 'cui_str': 'Skin of foreskin (body structure)'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0009332', 'cui_str': 'Collagen Type III'}, {'cui': 'C0227952', 'cui_str': 'Foreskin'}]",33.0,0.0409761,Mean epidermal thickness and collagen type I expression in EG were greater than those of the other groups.,"[{'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Casali', 'Affiliation': 'Department of Surgery - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil; Department of Surgery - Hospital e Maternidade Therezinha de Jesus of the School of Medical Science and Health of Juiz de Fora (HMTJ-SUPREMA), Minas Gerais, Brazil. Electronic address: casalithais@hotmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Christina de Castro Paiva', 'Affiliation': 'Department of Surgery - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil; Department of Surgery - Hospital e Maternidade Therezinha de Jesus of the School of Medical Science and Health of Juiz de Fora (HMTJ-SUPREMA), Minas Gerais, Brazil.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Rodrigues', 'Affiliation': 'Departament of Morphology - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Santana Silva', 'Affiliation': 'Department of Surgery - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avarese de Figueiredo', 'Affiliation': 'Department of Surgery - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Bessa', 'Affiliation': 'Department of Surgery - State University of Feira de Santana (UEFS), Bahia, Brazil.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Bastos', 'Affiliation': 'Departament of Morphology - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Marques Nogueira Castañon', 'Affiliation': 'Departament of Morphology - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bastos Netto', 'Affiliation': 'Department of Surgery - Federal University of Juiz de Fora (UFJF), Minas Gerais, Brazil; Department of Surgery - Hospital e Maternidade Therezinha de Jesus of the School of Medical Science and Health of Juiz de Fora (HMTJ-SUPREMA), Minas Gerais, Brazil.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.05.014'] 951,31250477,'MusiMath' and 'Academic Music' - Two music-based intervention programs for fractions learning in fourth grade students.,"Music and mathematics require abstract thinking and using symbolic notations. Controversy exists regarding transfer from musical training to math achievements. The current study examined the effect of two integrated intervention programs representing holistic versus acoustic approaches, on fraction knowledge. Three classes of fourth graders attended 12 lessons on fractions: One class attended the 'MusiMath' holistic program (n = 30) focusing on rhythm within the melody. Another class attended the 'Academic Music' acoustic program (Courey et al., Educ Stud Math 81:251, 2012) (n = 25) which uses rhythm only. The third class received regular fraction lessons (comparison group, n = 22). Students in both music programs learned to write musical notes and perform rhythmic patterns through clapping and drumming as part of their fraction lessons. They worked toward adding musical notes to produce a number (fraction), and created addition/subtraction problems with musical notes. The music programs used a 4/4 time signature with whole, half, quarter and eighth notes. In the math lessons, the students learned the analogy between musical durations and 1 2 , 1 4 , 1 8 fractions, but also practiced fractions other than 1 2 , 1 4 , 1 8 . Music and math were assessed before, immediately following, and 3- and 6-months post-intervention. Pre- to post-intervention analyses indicated that only the 'MusiMath' group showed greater transfer to intervention-trained and untrained fractions than the comparison group. The 'Academic Music' group showed a trend on trained fractions. Although both music groups outperformed the comparison group 3- and 6-months post-intervention on trained fractions, only the 'MusiMath' group demonstrated greater gains in untrained fractions. Gains were more evident in trained than in untrained fractions. A video abstract of this article can be viewed at https://youtu.be/uJ_KWWDO624.",2020,"Although both music groups outperformed the comparison group 3- and 6-months post-intervention on trained fractions, only the 'MusiMath' group demonstrated greater gains in untrained fractions.","['fourth grade students', 'Three classes of fourth graders attended 12 lessons on fractions']",['regular fraction lessons'],['Music and math'],"[{'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]",,0.0207043,"Although both music groups outperformed the comparison group 3- and 6-months post-intervention on trained fractions, only the 'MusiMath' group demonstrated greater gains in untrained fractions.","[{'ForeName': 'Libby', 'Initials': 'L', 'LastName': 'Azaryahu', 'Affiliation': 'School of Education, Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Susan Joan', 'Initials': 'SJ', 'LastName': 'Courey', 'Affiliation': 'Graduate School of Education, Touro College, New York, New York.'}, {'ForeName': 'Rivka', 'Initials': 'R', 'LastName': 'Elkoshi', 'Affiliation': 'Faculty of Music Education, Levinsky College of Education, Tel Aviv, Israel.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Adi-Japha', 'Affiliation': 'School of Education, Bar-Ilan University, Ramat Gan, Israel.'}]",Developmental science,['10.1111/desc.12882'] 952,32161366,Oxytocin induces long-lasting adaptations within amygdala circuitry in autism: a treatment-mechanism study with randomized placebo-controlled design.,"Intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly explored as a potential treatment for targeting the core symptoms of autism spectrum disorder (ASD). To date, however, the impact of multiple-dose IN-OT treatment on human neural circuitry is largely unknown, and also the possibility that long-term IN-OT use may induce long-lasting neural adaptations remains unexplored. Using a double-blind, randomized, placebo-controlled, between-subject design (including 38 adult men with ASD), this treatment-mechanism study showed that 4 weeks of daily oxytocin administration (24 IU/day) significantly altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus) up to 4 weeks and 1 year post treatment. The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors. These observations contribute to a deeper mechanistic understanding of the neural substrates that underlie behavioral effects of multiple-dose IN-OT treatment, and provide initial insights into the long-lasting neural consequences of chronic IN-OT use on amygdala circuitry. Future studies are however warranted to further elucidate the long-term impact of IN-OT treatment on human neural circuitry and its behavioral consequences.",2020,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"['38 adult men with ASD', 'autism']","['neuropeptide oxytocin (IN-OT', 'oxytocin', 'Oxytocin', 'placebo']","['altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0228237', 'cui_str': 'Structure of superior temporal sulcus'}]",38.0,0.130252,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"[{'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium. Kaat.Alaerts@kuleuven.be.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bernaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jellina', 'Initials': 'J', 'LastName': 'Prinsen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dillen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Steyaert', 'Affiliation': 'Department of Neurosciences, Group Biomedical Sciences, Psychiatry Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wenderoth', 'Affiliation': 'Department of Health Sciences and Technology, Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0653-8'] 953,30780190,Impact of Azithromycin-Based Extended-Spectrum Antibiotic Prophylaxis on Noninfectious Cesarean Wound Complications.,"OBJECTIVE Adding azithromycin to standard antibiotic prophylaxis for unscheduled cesarean delivery has been shown to reduce postcesarean infections. Because wound infection with ureaplasmas may not be overtly purulent, we assessed the hypothesis that azithromycin-based extended-spectrum antibiotic prophylaxis also reduces wound complications that are identified as noninfectious. STUDY DESIGN This is a secondary analysis of the C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) randomized controlled trial, which enrolled women with singleton pregnancies ≥24 weeks who were undergoing nonelective cesarean. Women were randomized to adjunctive azithromycin or identical placebo up to 1 hour preincision. All wound complications occurring within 6 weeks were adjudicated into infection and noninfectious wound complications (seroma, hematoma, local cellulitis, and other noninfectious wound breakdown). The primary outcome for this analysis is the composite of noninfectious wound complications. RESULTS At a total of 14 sites, 2,013 women were randomized to adjunctive azithromycin ( n  = 1,019) or placebo ( n  = 994). Groups were similar at baseline. Although there was a lower rate of noninfectious wound complications in the azithromycin group compared with placebo (2.9 vs. 3.8%), this was not statistically significant ( p  = 0.22). CONCLUSION While adding azithromycin to usual antibiotic prophylaxis for nonelective cesarean delivery does reduce the risk of postcesarean infections, it did not significantly reduce the risk of postcesarean noninfectious wound complications.",2019,"Although there was a lower rate of noninfectious wound complications in the azithromycin group compared with placebo (2.9 vs. 3.8%), this was not statistically significant ( p  = 0.22). ","['At a total of 14 sites, 2,013 women', 'enrolled women with singleton pregnancies ≥24 weeks who were undergoing nonelective cesarean']","['placebo', 'azithromycin', 'adjunctive azithromycin', 'Azithromycin-Based Extended-Spectrum Antibiotic Prophylaxis', 'adjunctive azithromycin or identical placebo']","['composite of noninfectious wound complications', 'infection and noninfectious wound complications (seroma, hematoma, local cellulitis, and other noninfectious wound breakdown', 'Noninfectious Cesarean Wound Complications', 'rate of noninfectious wound complications']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1096106'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0038940', 'cui_str': 'Surgical Wound Dehiscence'}]",2013.0,0.628106,"Although there was a lower rate of noninfectious wound complications in the azithromycin group compared with placebo (2.9 vs. 3.8%), this was not statistically significant ( p  = 0.22). ","[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Ausbeck', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Jauk', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Boggess', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Obstetrics and Gynecology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Erin A S', 'Initials': 'EAS', 'LastName': 'Clark', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Esplin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Cleary', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Kellett', 'Initials': 'K', 'LastName': 'Letson', 'Affiliation': 'Department of Obstetrics and Gynecology, Mission Hospital, Asheville, North Carolina.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Mississippi, Jackson, Mississippi.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Abramovici', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Sciences Center, Houston, Texas.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Andrews', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1679914'] 954,31303367,The Comparison of Traditional Radial Access and Novel Distal Radial Access for Cardiac Catheterization.,"OBJECTIVES The traditional radial access (TRA) has been used almost routinely in coronary interventions in our clinic. Recently, we have started to use distal radial artery point as distal radial access (DRA) more frequently. The aim of this study is to compare these techniques (DRA and TRA) in terms of their safety, feasibility, and effectiveness. BACKGROUND Recently, the distal transradial access novel techniques have started to be used in coronary interventions, such as the anatomical snuffbox (AS) and DRA. METHODS This prospective, randomized study was carried out in a single center. The patients were selected from the catheterization laboratory of Medicana Ankara Hospital, between October 2018 and December 2018. Consecutive patients with TRA (103 patients) and DRA (102 patients) were randomized for coronary intervention. RESULTS Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group. The radial artery spasm was observed in 4 cases in TRA group, whereas no radial artery spasm was seen in DRA group (p < 0.0001). The transradial access time in the DRA group (46.85 ± 2.41 s) lasted longer than the TRA (36.66 ± 5.16 s, p = 0.008).In DRA, hemostasis seems quicker than TRA. CONCLUSIONS DRA is feasible and safe for coronary angiography and interventions like TRA. It can be used as an alternative technique.",2020,"RESULTS Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group.","['patients were selected from the catheterization laboratory of Medicana Ankara Hospital, between October 2018 and December 2018', 'Consecutive patients with TRA (103 patients) and DRA (102 patients', 'cardiac catheterization']","['traditional radial access (TRA', 'TRA', 'DRA', 'traditional radial access and novel distal radial access', 'techniques (DRA and TRA']","['transradial access time', 'radial artery spasm', 'safety, feasibility, and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",103.0,0.0243291,"RESULTS Successful catheterization was achieved in 99 of 103 (96.1%) patients in the TRA group and in 97 patients of 102 (95.1%) patients in the DRA group.","[{'ForeName': 'Veli', 'Initials': 'V', 'LastName': 'Vefalı', 'Affiliation': 'Medicana International Hospital, Cardiology Clinic, Ankara, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Sarıçam', 'Affiliation': 'Medicana International Hospital, Cardiology Clinic, Ankara, Turkey. Electronic address: saricamersin@yahoo.com.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.07.001'] 955,31840815,"Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer.","Selective internal radiotherapy (SIRT) is a liver-directed treatment involving the injection of yttrium-90 microspheres into the blood supply of liver tumours. There are very few studies assessing health-related quality of life (HRQOL) in patients treated with SIRT. Patients with liver metastases from colorectal cancer (CRC) were randomised in the FOXFIRE (FFr; ISRCTN83867919), SIRFLOX (SF; NCT00724503) and FOXFIRE-Global (FFrG; NCT01721954) trials of first-line oxaliplatin-fluorouracil (FOLFOX) chemotherapy combined with SIRT versus FOLFOX alone. HRQOL was assessed using the three-level EQ-5D, European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and EORTC Colorectal Liver Metastases cancer module (EORTC QLQ-LMC21) at baseline, ≤3 months, 6 months, 12 months and annually thereafter from randomisation, and at disease progression. Analyses were conducted on an intention-to-treat basis. In total, 554 patients were randomised to SIRT + FOLFOX and 549 patients to FOLFOX alone. HRQOL was statistically significant lower in SIRT + FOLFOX patients ≤3 months after SIRT administration in all three instruments, particularly global health, physical and role functioning and symptoms of fatigue, nausea/vomiting and appetite loss. By accepted thresholds, these differences were deemed not clinically important. Differences between SIRT + FOLFOX and FOLFOX alone over the 2-year follow up and at disease progression were also not clinically important. Although there is some decrease in HRQOL for up to 3 months following SIRT, the addition of SIRT to FOLFOX chemotherapy does not change HRQOL to a clinically important degree in metastatic CRC patients.",2020,"HRQOL was statistically significant lower in SIRT+FOLFOX patients ≤3 months after SIRT administration in all 3 instruments, particularly global health, physical and role functioning, and symptoms of fatigue, nausea/vomiting and appetite loss.","['metastatic CRC patients', 'metastatic colorectal cancer', '554 patients were randomised to SIRT+FOLFOX and 549 patients to', 'patients treated with SIRT', 'Patients with liver metastases from colorectal cancer (CRC']","['FOLFOX', 'Selective internal radiotherapy (SIRT', 'selective internal radiotherapy', 'oxaliplatin-fluorouracil (FOLFOX) chemotherapy combined with SIRT versus FOLFOX alone', 'SIRT+FOLFOX and FOLFOX']","['3-level EQ-5D, European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30', 'Quality of life', 'HRQOL', 'global health, physical and role functioning, and symptoms of fatigue, nausea/vomiting and appetite loss']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1136177', 'cui_str': 'SIRTs'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0555352', 'cui_str': 'Internal radiotherapy'}, {'cui': 'C1136177', 'cui_str': 'SIRTs'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",554.0,0.0454899,"HRQOL was statistically significant lower in SIRT+FOLFOX patients ≤3 months after SIRT administration in all 3 instruments, particularly global health, physical and role functioning, and symptoms of fatigue, nausea/vomiting and appetite loss.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fusco', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moschandreas', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Pradeep S', 'Initials': 'PS', 'LastName': 'Virdee', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Van Hazel', 'Affiliation': 'University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'Western Hospital, Footscray, VIC, Australia.'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Wasan', 'Affiliation': 'Department of Oncology and Cancer Medicine, Imperial College Healthcare NHS Trust & Imperial College, London, United Kingdom.'}, {'ForeName': 'Ricky A', 'Initials': 'RA', 'LastName': 'Sharma', 'Affiliation': 'University College London Hospitals Biomedical Research Centre, NIHR, UCL Cancer Institute, University College London, London, United Kingdom.'}]",International journal of cancer,['10.1002/ijc.32828'] 956,31283096,Intermittent pneumatic compression in patients with ESRD. A systematic review.,"INTRODUCTION Patients with end-stage renal disease (ESRD) experience frequent hemodialysis (HD) complications. Intradialytic hypotension (IDH) is a common complication presenting in approximately between 20 and 50% of HD sessions. Available interventions such as volume replacement or vasoactive medications are associated with significant side effects. Intermittent pneumatic compression (IPC) has been proposed as a feasible intervention for the prevention of IDH, treatment of peripheral arterial disease and venous ulcers. These devices apply intermittent pressure to the legs improving arterial blood flow, mobilization of pooled blood with an increase in venous return increasing the effective circulatory volume. Our goal was to identify the published clinical evidence on whether IPC has a circulatory benefit and is it well-tolerated among patients receiving HD. METHODS We conducted a systematic review to identify studies assessing the efficacy and safety of IPC in patients with ESRD. Our primary outcome was IDH. Secondary outcomes such as HD comfort, ultrafiltration volume, and physical activity were collected. No restrictions where used and we included all observational and interventional studies. Two reviewers performed screening and study quality assessment. FINDINGS We included seven studies. Out of the seven studies, five addressed IDH, and the rest were included for secondary outcomes such as physical capacity and HD comfort. In one randomized crossover trial comparing exercise against IPC, 21 patients were randomized to 3 different arms (no intervention, cycling, IPC) a decrease in the rates of IDH with IPC was described (43%, 38%, and 24% respectively P = 0.014). The smaller studies corroborated these results. All studies where at high risk of bias. DISCUSSION IPC might offer significant benefits for patients undergoing HD not limited to prevention of IDH but also improvement of hemodialysis comfort and physical capacity. However, our results should be interpreted in the context of its limitations.",2019,"These devices apply intermittent pressure to the legs improving arterial blood flow, mobilization of pooled blood with an increase in venous return increasing the effective circulatory volume.","['Patients with end-stage renal disease (ESRD) experience frequent hemodialysis (HD) complications', 'patients with ESRD', 'patients undergoing HD', 'patients receiving HD']","['IPC', 'Intermittent pneumatic compression', 'Intermittent pneumatic compression (IPC', 'exercise against IPC']","['rates of IDH with IPC', 'physical capacity and HD comfort', 'Intradialytic hypotension (IDH', 'HD comfort, ultrafiltration volume, and physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0274417', 'cui_str': 'Complication of hemodialysis (disorder)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",21.0,0.0902348,"These devices apply intermittent pressure to the legs improving arterial blood flow, mobilization of pooled blood with an increase in venous return increasing the effective circulatory volume.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Department of Internal Medicine, John H. Stroger Jr. Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Harry E', 'Initials': 'HE', 'LastName': 'Fuentes', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Saadaldin', 'Affiliation': 'Department of Medicine, October 6 University, Cairo, Egypt.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Salazar', 'Affiliation': 'Department of Internal Medicine, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Paz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Diaz', 'Affiliation': 'Department of Internal Medicine, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Doukky', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, Division of Nephrology, John H. Stroger Jr. Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Alfonso J', 'Initials': 'AJ', 'LastName': 'Tafur', 'Affiliation': 'Department of Medicine, Division of Vascular Medicine, NorthShore University Health System, Evanston, Illinois, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12771'] 957,32409944,"Evidence for improved survival with bevacizumab treatment in recurrent high-grade gliomas: a retrospective study with (""pseudo-randomized"") treatment allocation by the health insurance provider.","INTRODUCTION Despite a large number of trials, the role of bevacizumab (BEV) in the treatment of recurrent high-grade gliomas is still controversial. Evidence regarding an effect on overall survival in this context is ultimately inconclusive. At the Department of Radiation Oncology at Erlangen, Germany we treated a large cohort of patients with recurrent gliomas where bevacizumab use was determined exclusively by the health care provider's approval of reimbursement. METHODS 61 patients (between 06/2008 and 01/2014) with recurrent high-grade gliomas had reimbursement requests for BEV sent to their health insurance. 37 patients out of 61 (60.7%) had their requests approved and therefore received bevacizumab (BEV-arm) as part of their treatment. The remaining 24 (39.3%) patients received standard therapy without bevacizumab (non-BEV-arm). Survival endpoints were defined with reference to the first BEV request to the health insurance provider. RESULTS Median overall survival (OS) for the whole cohort was 7.0 months. OS was significantly better for BEV vs. Non-BEV patients (median, 10.3 vs. 4.2 months, logrank p = 0.023). There was an increased BEV benefit in cases of higher-order recurrences (first order recurrence BEV vs. Non-BEV, 12.5 vs. 10.2 months, p = 0.578) (second or higher order of recurrence, 9.9 vs. 2.6 months, p = 0.010). On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant. CONCLUSION Our results suggest an influence of BEV on overall survival in a heavily pretreated patient population suffering from high-grade gliomas with BEV benefit being greatest in case of second or later recurrence.",2020,"On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant. ","['recurrent high-grade gliomas', '61 patients (between 06/2008 and 01/2014) with recurrent high-grade gliomas had reimbursement requests for BEV sent to their health insurance', '37 patients out of 61 (60.7%) had their requests approved and therefore received']","['standard therapy without bevacizumab', 'bevacizumab (BEV', 'bevacizumab']","['OS', 'overall survival', 'survival', 'Median overall survival (OS', 'BEV benefit', 'Survival endpoints']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",61.0,0.0806815,"On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant. ","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hofmann', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Manuel Alexander', 'Initials': 'MA', 'LastName': 'Schmidt', 'Affiliation': 'Department of Neuroradiology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weissmann', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Eyüpoglu', 'Affiliation': 'Department of Neurosurgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Annedore', 'Initials': 'A', 'LastName': 'Strnad', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Semrau', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Putz', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany. florian.putz@uk-erlangen.de.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lettmaier', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03533-5'] 958,31262379,Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma.,"Background: Spirometric lung age expresses lung function relative to chronological age. It has been effective in encouraging smoking cessation and has been used in the assessment of asthma. Reslizumab, a humanized anti-interleukin-5 monoclonal antibody, is approved as add-on therapy for adults with severe asthma and elevated blood eosinophils. Objective: To assess the effect of reslizumab versus placebo on the change in lung age over 52 weeks and the correlation between change in lung age and quality of life in moderate-to-severe asthma. Methods: This was a post hoc analysis of two randomized, double-blind, placebo-controlled trials. Patients ages 12-75 years with moderate-to-severe, inadequately controlled asthma and elevated blood eosinophils received intravenous reslizumab 3.0 mg/kg or placebo every 4 weeks for 1 year. Spirometry was performed every 4 weeks, and the Asthma Quality of Life Questionnaire (AQLQ) score was assessed at baseline and weeks 16, 32, and 52. Results: Mean improvement in lung-age deficit at week 52 was -8.73 years for reslizumab versus -3.80 years for placebo, a treatment difference of 5 years ( p < 0.0001). A statistically significant effect was seen as early as 4 weeks. In AQLQ responders (a ≥ 0.5 increase in AQLQ score), a statistically significant inverse relationship between the change from baseline in lung age and AQLQ score at weeks 16, 32, and 52 was observed among patients treated with reslizumab only. Among lung-age responders (≥5 years' reduction), a statistically significantly greater proportion of patients on reslizumab achieved ≥0.5 increase in the AQLQ score versus placebo at all time points. Conclusion: Reslizumab reduced lung-age deficit by 5 years in patients with moderate-to-severe inadequately controlled eosinophilic asthma. Improvement in lung age correlated with improved quality of life. Lung age is a simple indication of pulmonary function and could be a valuable tool in asthma education.Clinical trials NCT01287039 and NCT01285323, www.clinicaltrials.gov.",2019,"In AQLQ responders (a ≥ 0.5 increase in AQLQ score), a statistically significant inverse relationship between the change from baseline in lung age and AQLQ score at weeks 16, 32, and 52 was observed among patients treated with reslizumab only.","['patients with moderate-to-severe inadequately controlled eosinophilic asthma', 'Patients ages 12-75 years with moderate-to-severe, inadequately controlled asthma and elevated blood eosinophils received', 'adults with severe asthma and elevated blood eosinophils', 'patients with moderate-to-severe eosinophilic asthma']","[' ext-link-type=""uri"" xlink', 'placebo', 'reslizumab versus placebo', 'reslizumab', 'href=""http://www.clinicaltrials.gov"">www.clinicaltrials.gov 0.05). CONCLUSION This study demonstrated a very good tolerance rate on behalf of the significant results achieved.",2019,"The therapy had a significant effect on the difference between groups in all the outcomes (p < 0.05 in all cases) with a large effect size with exception of the RSP/F (p > 0.05). ","['Patients with probable AD diagnosis', 'Ninety elderly people participated in this study, precisely 50 women and 40 men aged 67-92 years (mean age = 81.17, SD = 5.24', ""patients with Alzheimer's disease (AD"", 'Nursing homes']","['global postural reeducation method (GPR', 'Global Postural Reeducation']","[""Neuropsychiatric Inventory, Mini Mental State Examination, Geriatric Depression Scale, Quality of Life in Alzheimer's Disease and Tinetti Scale and respiratory rate frequency (RSP/F""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0222045'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",50.0,0.0557736,"The therapy had a significant effect on the difference between groups in all the outcomes (p < 0.05 in all cases) with a large effect size with exception of the RSP/F (p > 0.05). ","[{'ForeName': 'Jasemin', 'Initials': 'J', 'LastName': 'Todri', 'Affiliation': 'Health Sciences Department, Universidad Catolica de Murcia UCAM, Murcia, Spain, jasemin.todri@gmail.com.'}, {'ForeName': 'Ardita', 'Initials': 'A', 'LastName': 'Todri', 'Affiliation': 'Statistics Specialist Area. Economics Faculty, Universiteti Aleksander Xhuvani, Elbasan, Albania.'}, {'ForeName': 'Orges', 'Initials': 'O', 'LastName': 'Lena', 'Affiliation': 'Health Sciences Department, Universidad Catolica de Murcia UCAM, Murcia, Spain.'}]",Dementia and geriatric cognitive disorders,['10.1159/000505397'] 981,31206593,"AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.","BACKGROUND MSB11022 is a proposed adalimumab biosimilar. OBJECTIVES To compare the efficacy, safety and immunogenicity of MSB11022 with reference adalimumab. METHODS AURIEL-PsO was a double-blind randomized controlled equivalence trial, in which patients with moderate-to-severe chronic plaque-type psoriasis were randomized 1 : 1 to MSB11022 or reference adalimumab. The primary end point was ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16, with a prespecified equivalence interval of ± 18%. Patients with a ≥50% improvement in PASI at week 16 were eligible to enter a double-blind extension period: patients receiving MSB11022 continued treatment, and patients receiving reference adalimumab were rerandomized 1 : 1 either to continue reference adalimumab or to switch to MSB11022. Other efficacy end points and safety, immunogenicity and pharmacokinetic parameters were evaluated at scheduled visits up to weeks 52 (efficacy and immunogenicity), 54 and 66 (safety). RESULTS In total, 443 patients were randomized. The difference in PASI 75 response rates at week 16 between the treatment arms was -1·9%, and the 95% confidence interval (-7·8% to 4·1%) was within the prespecified equivalence interval. No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the trial, and no new safety signals were observed. Following treatment switch at week 16, no clinically meaningful differences in safety or immunogenicity were seen between treatment arms through to the end of the observation period. CONCLUSIONS Therapeutic equivalence between MSB11022 and reference adalimumab was demonstrated. AURIEL-PsO provides evidence to support the similarity of both products with regard to efficacy, safety and immunogenicity. What's already known about this topic? Adalimumab is a fully human antitumour necrosis factor-α monoclonal antibody, indicated for the treatment of multiple inflammatory disorders, including psoriasis, psoriatic arthritis, rheumatoid arthritis, inflammatory bowel diseases and ankylosing spondylitis. MSB11022 is a proposed adalimumab biosimilar that has shown structural and functional similarity to the reference product in an extensive analytical comparability exercise. MSB11022 has demonstrated bioequivalence and comparable safety and immunogenicity profiles in a phase I study in healthy volunteers. What does this study add? This phase III study confirmed equivalent efficacy for MSB11022 and reference adalimumab in patients without any immunomodulation comedication in moderate-to-severe chronic plaque-type psoriasis at week 16. The efficacy, safety and immunogenicity of MSB11022 and reference adalimumab were similar over the respective observation periods (week 52 for efficacy and immunogenicity, week 66 for safety). A switch from reference adalimumab to MSB11022 at week 16 did not impact efficacy, safety or immunogenicity.",2020,"No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the trial, and no new safety signals were observed.","['patients with moderate-to-severe chronic plaque-type psoriasis', '443 patients were randomised', 'Patients with a ≥50% improvement in PASI at Week 16 were eligible to enter a double-blind extension period: patients receiving MSB11022 continued treatment, and patients receiving reference']","['adalimumab', 'MSB11022 or reference adalimumab', 'continue reference adalimumab or switch to MSB11022']","['safety or immunogenicity', 'efficacy, safety and immunogenicity', 'Psoriasis Area and Severity Index (PASI', 'PASI 75 response rates', 'efficacy endpoints, safety, immunogenicity and pharmacokinetic parameters', 'incidence of treatment-emergent adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",443.0,0.177122,"No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the trial, and no new safety signals were observed.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hercogová', 'Affiliation': 'Dermatology Department, 2nd Medical Faculty, Charles University and Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Chyrok', 'Affiliation': 'Fresenius Kabi, Eysin, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ullmann', 'Affiliation': 'Fresenius Kabi, Eysin, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vlachos', 'Affiliation': 'Cytel, Geneva, Switzerland.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': 'NIHR Clinical Research Facility, University of Southampton, Southampton, U.K.'}]",The British journal of dermatology,['10.1111/bjd.18220'] 982,29948858,Beneficial effects of adaptive servo-ventilation on natriuretic peptides and diastolic function in acute heart failure patients with preserved ejection fraction and sleep-disordered breathing.,"PURPOSE Adaptive servo-ventilation (ASV) is a ventilator algorithm able to correct breathing through anticyclic support of breathing in patients with central sleep apnea (CSA). So far, very few data exist regarding the role of ASV on acute heart failure with preserved ejection fraction (HFpEF). METHODS We performed a single-center prospective, randomized, case-control study in consecutive acute HFpEF (left ventricle ejection fraction, LVEF ≥ 45%) patients with sleep-disordered breathing (SDB, apnea-hypopnea index, AHI > 15/h) and prevalence of CSA. RESULTS We included ten consecutive patients randomized for ASV on top of standard therapy for acute heart failure (group 1) versus standard care alone (group 2). ASV therapy significantly reduced AHI and CSA. An improvement in cardiac diastolic function was seen in group 1 compared to group 2 (E/E' 17.5 to 9.6, p < 0.02 vs 18.5 to 14.5, p = 0.4). Brain natriuretic peptide (BNP) markedly decreased in cases, but not in controls (298 to 84 pg/ml, p < 0.02 vs 280 to 120 pg/ml, p = 0.06). Right ventricle (RV) function significantly improved in group 1, differently from group 2. CONCLUSIONS An acute use of ASV seems effective in reducing BNP and improving diastolic and RV function in acute HFpEF patients with SDB and CSA, compared to standard treatment.",2019,"An improvement in cardiac diastolic function was seen in group 1 compared to group 2 (E/E' 17.5 to 9.6, p < 0.02 vs 18.5 to 14.5, p = 0.4).","['acute heart failure patients with preserved ejection fraction and sleep-disordered breathing', 'consecutive acute HFpEF', 'patients with SDB and CSA', 'patients with central sleep apnea (CSA', 'acute HFpEF']","['ASV', 'standard care alone', 'adaptive servo-ventilation', 'Adaptive servo-ventilation (ASV', 'ASV therapy']","['sleep-disordered breathing (SDB, apnea-hypopnea index, AHI >\u200915/h) and prevalence of CSA', 'Brain natriuretic peptide (BNP', 'AHI and CSA', 'natriuretic peptides and diastolic function', 'cardiac diastolic function', 'BNP and improving diastolic and RV function', 'Right ventricle (RV) function']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4285752', 'cui_str': 'Adaptive support ventilation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0225883', 'cui_str': 'Right Ventricle'}]",10.0,0.028878,"An improvement in cardiac diastolic function was seen in group 1 compared to group 2 (E/E' 17.5 to 9.6, p < 0.02 vs 18.5 to 14.5, p = 0.4).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': ""D'Elia"", 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ferrero', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vittori', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Iacovoni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grosu', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Duino', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perlini', 'Affiliation': 'Clinica Medica 2 Internal Medicine Department IRCCS San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy. msenni@asst-pg23.it.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1681-z'] 983,29951886,Metoprolol has a similar therapeutic effect as amlodipine on BP lowering in hypertensive patients with obstructive sleep apnea.,"PURPOSE β-Blocker use has been controversial for a long time in the management of hypertensive patients with obstructive sleep apnea (OSA). The aim of present study was to compare the effects of metoprolol on BP lowering with amlodipine in hypertensive OSA patients. METHODS Hypertensive subjects with OSA were randomly assigned to metoprolol and amlodipine groups, receiving 12 weeks of oral either metoprolol (47.5 mg once daily) or amlodipine (5 mg once daily) treatment. At baseline and after the 12-week treatment period, 24-h ambulatory blood pressure monitoring was performed in both groups. RESULTS Both of metoprolol and amlodipine treatments significantly lowered 24-h blood pressure (BP) (from 143/88 to 132.3/81.6 mmHg; from 141.3/84.5 to 133.7/80.8 mmHg), daytime BP (from 146/90.2 to 136.4/84.6 mmHg; from 145.1/87.6 to 138.2/84.1 mmHg), and nighttime BP (from 139.1/83.9 to 125.7/76.2 mmHg; from 134.5/78.5 to 125.8/74.1 mmHg) (all P < 0.05). But there were no significant differences between the groups in BP variability (P > 0.05). Besides, metoprolol significantly reduced daytime heart rate (HR) (P < 0.05), while 24-h and nighttime HR values had no remarkable changes compared with baseline (P > 0.05). CONCLUSIONS Metoprolol had similar therapeutic effects on BP lowering as amlodipine and could not decrease HR during the nighttime in hypertensive patients with OSA.",2019,"Besides, metoprolol significantly reduced daytime heart rate (HR) (P < 0.05), while 24-h and nighttime HR values had no remarkable changes compared with baseline (P > 0.05). ","['hypertensive patients with OSA', 'hypertensive patients with obstructive sleep apnea', 'hypertensive patients with obstructive sleep apnea (OSA', 'hypertensive OSA patients', 'Hypertensive subjects with OSA']","['amlodipine', 'Metoprolol', 'metoprolol and amlodipine', 'metoprolol']","['24-h blood pressure (BP', '24-h ambulatory blood pressure monitoring', 'BP lowering', '24-h and nighttime HR values', 'BP variability', 'daytime heart rate (HR', 'nighttime BP', 'daytime BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C4301622', 'cui_str': 'metoprolol and amlodipine'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0131591,"Besides, metoprolol significantly reduced daytime heart rate (HR) (P < 0.05), while 24-h and nighttime HR values had no remarkable changes compared with baseline (P > 0.05). ","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Xianzhu', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Meijiao', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Danghui', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Wennan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China. ly99ly@vip.163.com.""}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1688-5'] 984,31839082,Effects of Intrathecal Bupivacaine and Bupivacaine Plus Fentanyl in Elderly Patients Undergoing Total Hip Arthroplasty.,"OBJECTIVE To determine and compare the clinical efficacy of spinal anesthesia with bupivacaine combined with fentanyl and bupivacaine alone in geriatric patients scheduled for total hip arthroplasty (THA). STUDY DESIGN Experimental study. PLACE AND DURATION OF STUDY Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China, from April 2016 to April 2017. METHODOLOGY Sixty-five geriatric patients were randomised into two groups. Group B was anesthetised with 0.5% bupivacaine 10 mg and Group F with 0.5% bupivacaine 7.5 mg plus fentanyl 20 μg. Hemodynamic stability, effect and satisfaction of anesthesia, time to the first postoperative analgesic requirement, adverse effects, and incidence of postoperative indwelling catheter were compared. RESULTS There was no significant difference in time to reach maximum sensory block level, maximum sensory block level, maximum motor block, duration of motor block, quality of anesthesia, adverse effects or the incidence of postoperative indwelling catheter between the two groups. However, Group F required less dosage of ephedrine for stable hemodynamics and longer time to use the primary postoperative analgesic in comparison to Group B (p<0.05). CONCLUSION Adding 20 μg fentanyl to a lower dose of 7.5 mg bupivacaine can provide safe and effective spinal anesthesia for THA in geriatric patients.",2019,"There was no significant difference in time to reach maximum sensory block level, maximum sensory block level, maximum motor block, duration of motor block, quality of anesthesia, adverse effects or the incidence of postoperative indwelling catheter between the two groups.","['Elderly Patients Undergoing Total Hip Arthroplasty', 'geriatric patients', 'geriatric patients scheduled for total hip arthroplasty (THA', 'Sixty-five geriatric patients', 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China, from April 2016 to April 2017']","['ephedrine', 'bupivacaine', 'bupivacaine combined with fentanyl and bupivacaine', 'Bupivacaine Plus Fentanyl', 'Intrathecal Bupivacaine', 'bupivacaine 7.5 mg plus fentanyl']","['safe and effective spinal anesthesia', 'Hemodynamic stability, effect and satisfaction of anesthesia, time to the first postoperative analgesic requirement, adverse effects, and incidence of postoperative indwelling catheter', 'time to reach maximum sensory block level, maximum sensory block level, maximum motor block, duration of motor block, quality of anesthesia, adverse effects or the incidence of postoperative indwelling catheter']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",65.0,0.0229986,"There was no significant difference in time to reach maximum sensory block level, maximum sensory block level, maximum motor block, duration of motor block, quality of anesthesia, adverse effects or the incidence of postoperative indwelling catheter between the two groups.","[{'ForeName': 'Huaxin', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhan', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yeda', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2019.12.1133'] 985,31256177,A web-based educational intervention module to improve knowledge and attitudes towards thalassaemia prevention in Malaysian young adults.,"BACKGROUND Thalassaemia is a public health burden in Malaysia and its prevention faces many challenges. In this study, we aimed to assess the effectiveness of a web-based educational module in improving knowledge and attitudes about thalassaemia prevention amongst Malaysian young adults. METHODS We designed an interactive web-based educational module in the Malay language wherein videos were combined with text and pictorial visual cues. Malaysians aged 18-40 years old who underwent the module had their knowledge and attitudes assessed at baseline, post-intervention and at 6-month follow-up using a selfadministered validated questionnaire. RESULTS Sixty-five participants: 47 Malays (72.3%), 15 Chinese (23.1%), three Indians (4.6%) underwent the module. Questionnaires were completed at baseline (n=65), postintervention (n=65) and at 6-month follow-up (n=60). Out of a total knowledge score of 21, significant changes were recorded across three time-points- median scores were 12 at pre-intervention, 19 at post-intervention and 16 at 6-month follow-up (p<0.001). Post-hoc testing comparing preintervention and 6-month follow-up scores showed significant retention of knowledge (p<0.001). Compared to baseline, attitudes at 6-month follow-up showed an increased acceptance for ""marriage avoidance between carriers"" (pre-intervention 20%, 6-month follow-up 48.3%, p<0.001) and ""prenatal diagnosis"" (pre-intervention 73.8%, 6-month follow-up 86.2%, p=0.008). Acceptance for selective termination however, remained low without significant change (pre-intervention 6.2%, 6-month follow-up 16.7%, p=0.109). CONCLUSION A web-based educational module appears effective in improving knowledge and attitudes towards thalassaemia prevention and its incorporation in thalassaemia prevention programs is potentially useful in Malaysia and countries with a high internet penetration rate.",2019,"Compared to baseline, attitudes at 6-month follow-up showed an increased acceptance for ""marriage avoidance between carriers"" (pre-intervention 20%, 6-month follow-up 48.3%, p<0.001) and ""prenatal diagnosis"" (pre-intervention 73.8%, 6-month follow-up 86.2%, p=0.008).","['Sixty-five participants: 47 Malays (72.3%), 15 Chinese (23.1', 'Malaysians aged 18-40 years old who underwent the module had their knowledge and attitudes assessed at baseline, post-intervention and at 6-month follow-up using a selfadministered validated questionnaire', 'Malaysian young adults']","['web-based educational module', 'interactive web-based educational module in the Malay language wherein videos were combined with text and pictorial visual cues']","['prenatal diagnosis', 'knowledge and attitudes towards thalassaemia prevention', 'acceptance for ""marriage avoidance', 'knowledge and attitudes about thalassaemia prevention']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0337905', 'cui_str': 'Malays'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0024549', 'cui_str': 'Malay language (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0033053', 'cui_str': 'Intrauterine Diagnosis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}]",65.0,0.0536071,"Compared to baseline, attitudes at 6-month follow-up showed an increased acceptance for ""marriage avoidance between carriers"" (pre-intervention 20%, 6-month follow-up 48.3%, p<0.001) and ""prenatal diagnosis"" (pre-intervention 73.8%, 6-month follow-up 86.2%, p=0.008).","[{'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Ngim', 'Affiliation': 'Monash University Malaysia, Jeffrey Cheah School of Medicine and Health Sciences, Malaysia. chin.fang.ngim@monash.edu.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Paediatrics, Institut Pediatrik, Hospital Kuala Lumpur, Malaysia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Abdullah', 'Affiliation': 'Hospital Sultanah Aminah, Department of Paediatrics, Johor Bahru, Malaysia.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Lai', 'Affiliation': ""Taylor's University, School of Medicine, Subang Jaya, Selangor, Malaysia.""}, {'ForeName': 'R K M', 'Initials': 'RKM', 'LastName': 'Tan', 'Affiliation': 'Monash University Malaysia, Jeffrey Cheah School of Medicine and Health Sciences, Malaysia.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Ng', 'Affiliation': 'Hospital Sultanah Aminah, Department of Nuclear Medicine, Johor Bahru, Malaysia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramadas', 'Affiliation': 'Monash University Malaysia, Jeffrey Cheah School of Medicine and Health Sciences, Malaysia.'}]",The Medical journal of Malaysia,[] 986,30995645,Ultrasound-Guided Continuous Femoral Nerve Block with Dexmedetomidine Combined with Low Concentrations of Ropivacaine for Postoperative Analgesia in Elderly Knee Arthroplasty.,"OBJECTIVES This study aims to investigate the clinical effect of dexmedetomidine (DEX) combined with low concentrations of ropivacaine in ultrasound-guided continuous fem-oral nerve block for postoperative analgesia in elderly patients with total knee arthroplasty (TKA). MATERIALS AND METHODS Patients were divided into three groups: group C, group D1, and group D2. For postoperative analgesia, patients in group C were given 0.15% ropivacaine, patients in group D1 were given 0.15% ropivacaine + 0.02 μg × kg-1 × h-1 DEX, and patients in group D2 were given 0.15% ropivacaine + 0.05 μg × kg-1 × h-1 DEX. The visual analogue scores in the resting state, active state (AVAS), and passive functional exercise state (PVAS), degree of joint bending, and Ramsay scores were recorded. RESULTS The Ramsay scores were significantly higher, AVAS scores were significantly lower, PVAS scores were significantly decreased, the degree of joint bending was significantly higher, and the time to the first postoperative ambulation was shorter in groups D1 and D2 than group C. Furthermore, the time to the first postoperative ambulation was shorter in group D2 than in group D1, patients in groups D1 and D2 were more satisfied than patients in group C, and patients in group D2 were more satisfied than patients in group D1. CONCLUSION The protocol of 0.05 μg × kg-1 × h-1 of DEX combined with 0.15% ro-pivacaine in ultrasound-guided continuous femoral nerve block for postoperative analgesia in elderly patients with TKA provides a better analgesic effect than without DEX performance. X.-Y.Z. and E.-F.Z. have contributed equally to this research.",2019,"The Ramsay scores were significantly higher, AVAS scores were significantly lower, PVAS scores were significantly decreased, the degree of joint bending were significantly higher, and the time for first postoperative ambulation was shorter in groups D1 and D2, compared to group C. Furthermore, the time for first postoperative ambulation was shorter in group D2 than in group D1, patients in groups D1 and D2 were more satisfied than patients in group C, and patients in group D2 were more satisfied than patients in group D1. ","['elderly patients with TKA', 'Patients', 'Elderly Knee Arthroplasty', 'elderly patients with total knee arthroplasty (TKA']","['dexmedetomidine (DEX', 'ropivacaine + 0.05 μg·kg-1·h-1 DEX', 'ropivacaine', 'ropivacaine + 0.02 μg·kg-1·h-1 DEX', 'Dexmedetomidine Combined with Low Concentrations of Ropivacaine', 'DEX combined with 0.15% ropivacaine']","['visual analogue scores in the resting state (RVAS), active state (AVAS) and passive functional exercise state (PVAS), degree of joint bending, and Ramasy scores', 'PVAS scores', 'time for first postoperative ambulation', 'Ramsay scores', 'degree of joint bending', 'AVAS scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0139386', 'cui_str': 'PVAS'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}]",,0.0427687,"The Ramsay scores were significantly higher, AVAS scores were significantly lower, PVAS scores were significantly decreased, the degree of joint bending were significantly higher, and the time for first postoperative ambulation was shorter in groups D1 and D2, compared to group C. Furthermore, the time for first postoperative ambulation was shorter in group D2 than in group D1, patients in groups D1 and D2 were more satisfied than patients in group C, and patients in group D2 were more satisfied than patients in group D1. ","[{'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Er-Fei', 'Initials': 'EF', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Yan'an University, Yan'an, China.""}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Bai', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Zi-Jian', 'Initials': 'ZJ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Peng-Yun', 'Initials': 'PY', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Yan-Nan', 'Initials': 'YN', 'LastName': 'Li', 'Affiliation': 'Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Jian-Xin', 'Initials': 'JX', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Shanxi Medical University, Taiyuan, China, yangjxin66@163.com.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000500261'] 987,31305506,REDUCTION OF POSTINTRAVITREAL INJECTION PAIN USING ICE: An Open-Label Interventional Randomized Controlled Trial.,"PURPOSE Intravitreal injections of intraocular therapeutic agents are a common and effective treatment for various retinal pathologies. Patient discomfort related to injection is a potential barrier to treatment. Our aim in this study was to evaluate whether cooling the eye using topical ice compresses before intravitreal injection will reduce pain or bleeding. METHODS This randomized controlled open-label study included 42 patients. All patients received a standard topical anesthesia protocol and then were randomly assigned to either receive a placement of ice packs (intervention group) or a room-temperature pack (control group) on the eyelid, 2 minutes before the intravitreal injection. Patients' discomfort, itching, burning and pain (using visual analog scale), and bleeding size (using photographs) were measured 1 and 10 minutes after the injection. Tolerability was calculated by averaging patients' discomfort, itching, burning, and pain scores. RESULTS At 1 minute, pain (1.95 vs. 4.27, P = 0.01) and overall tolerability (1.66 vs. 2.98, P = 0.03) were significantly lower in patients receiving ice packs. At 10 minutes, pain (1.6 vs. 3.73, P = 0.02), burning (0.9 vs. 3.09, P = 0.007), discomfort (2.1 vs. 4.27, P = 0.008), and overall tolerability (1.23 vs. 2.87, P = 0.004) were all significantly lower in the ice group compared with the controls. Bleeding size (area or circumference) was not statistical different between groups. CONCLUSION Topical ice patch administered before intravitreal injection significantly decreased pain and overall tolerability. This simple and inexpensive method may be used to ameliorated pain and improve tolerability.",2020,"At 10 minutes, pain (1.6 vs. 3.73, P = 0.02), burning (0.9 vs. 3.09, P = 0.007), discomfort (2.1 vs. 4.27, P = 0.008), and overall tolerability (1.23 vs. 2.87, P = 0.004) were all significantly lower in the ice group compared with the controls.",['42 patients'],"['ICE', 'standard topical anesthesia protocol', 'placement of ice packs (intervention group) or a room-temperature pack (control group']","['discomfort, itching, burning and pain (using visual analog scale), and bleeding size (using photographs', 'Bleeding size (area or circumference', 'pain and improve tolerability', 'pain', 'discomfort', 'pain and overall tolerability', 'discomfort, itching, burning, and pain scores', 'Tolerability', 'overall tolerability', 'pain or bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0181264', 'cui_str': 'Ice bag, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",42.0,0.0725399,"At 10 minutes, pain (1.6 vs. 3.73, P = 0.02), burning (0.9 vs. 3.09, P = 0.007), discomfort (2.1 vs. 4.27, P = 0.008), and overall tolerability (1.23 vs. 2.87, P = 0.004) were all significantly lower in the ice group compared with the controls.","[{'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Yahalomi', 'Affiliation': 'Department of Ophthalmology, Assuta Universitary Medical Center, Ashdod, Israel.'}, {'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Hecht', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Lagstein', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Achia', 'Initials': 'A', 'LastName': 'Nemet', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Peʼer', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'Hadad', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Keren-Yaar', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Rabea', 'Initials': 'R', 'LastName': 'Kassem', 'Affiliation': 'Department of Ophthalmology, Kaplan Medical Center, Rehovot and the Hebrew University of Jerusalem-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Zvia', 'Initials': 'Z', 'LastName': 'Burgansky-Eliash', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Asaf', 'Initials': 'A', 'LastName': 'Bar', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Asaf', 'Initials': 'A', 'LastName': 'Achiron', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002608'] 988,31174831,"The safety and immunogenicity of two novel live attenuated monovalent (serotype 2) oral poliovirus vaccines in healthy adults: a double-blind, single-centre phase 1 study.","BACKGROUND Use of oral live-attenuated polio vaccines (OPV), and injected inactivated polio vaccines (IPV) has almost achieved global eradication of wild polio viruses. To address the goals of achieving and maintaining global eradication and minimising the risk of outbreaks of vaccine-derived polioviruses, we tested novel monovalent oral type-2 poliovirus (OPV2) vaccine candidates that are genetically more stable than existing OPVs, with a lower risk of reversion to neurovirulence. Our study represents the first in-human testing of these two novel OPV2 candidates. We aimed to evaluate the safety and immunogenicity of these vaccines, the presence and extent of faecal shedding, and the neurovirulence of shed virus. METHODS In this double-blind, single-centre phase 1 trial, we isolated participants in a purpose-built containment facility at the University of Antwerp Hospital (Antwerp, Belgium), to minimise the risk of environmental release of the novel OPV2 candidates. Participants, who were recruited by local advertising, were adults (aged 18-50 years) in good health who had previously been vaccinated with IPV, and who would not have any contact with immunosuppressed or unvaccinated people for the duration of faecal shedding at the end of the study. The first participant randomly chose an envelope containing the name of a vaccine candidate, and this determined their allocation; the next 14 participants to be enrolled in the study were sequentially allocated to this group and received the same vaccine. The subsequent 15 participants enrolled after this group were allocated to receive the other vaccine. Participants and the study staff were masked to vaccine groups until the end of the study period. Participants each received a single dose of one vaccine candidate (candidate 1, S2/cre5/S15domV/rec1/hifi3; or candidate 2, S2/S15domV/CpG40), and they were monitored for adverse events, immune responses, and faecal shedding of the vaccine virus for 28 days. Shed virus isolates were tested for the genetic stability of attenuation. The primary outcomes were the incidence and type of serious and severe adverse events, the proportion of participants showing viral shedding in their stools, the time to cessation of viral shedding, the cell culture infective dose of shed virus in virus-positive stools, and a combined index of the prevalence, duration, and quantity of viral shedding in all participants. This study is registered with EudraCT, number 2017-000908-21 and ClinicalTrials.gov, number NCT03430349. FINDINGS Between May 22 and Aug 22, 2017, 48 volunteers were screened, of whom 15 (31%) volunteers were excluded for reasons relating to the inclusion or exclusion criteria, three (6%) volunteers were not treated because of restrictions to the number of participants in each group, and 30 (63%) volunteers were sequentially allocated to groups (15 participants per group). Both novel OPV2 candidates were immunogenic and increased the median blood titre of serum neutralising antibodies; all participants were seroprotected after vaccination. Both candidates had acceptable tolerability, and no serious adverse events occurred during the study. However, severe events were reported in six (40%) participants receiving candidate 1 (eight events) and nine (60%) participants receiving candidate 2 (12 events); most of these events were increased blood creatinine phosphokinase but were not accompanied by clinical signs or symptoms. Vaccine virus was detected in the stools of 15 (100%) participants receiving vaccine candidate 1 and 13 (87%) participants receiving vaccine candidate 2. Vaccine poliovirus shedding stopped at a median of 23 days (IQR 15-36) after candidate 1 administration and 12 days (1-23) after candidate 2 administration. Total shedding, described by the estimated median shedding index (50% cell culture infective dose/g), was observed to be greater with candidate 1 than candidate 2 across all participants (2·8 [95% CI 1·8-3·5] vs 1·0 [0·7-1·6]). Reversion to neurovirulence, assessed as paralysis of transgenic mice, was low in isolates from those vaccinated with both candidates, and sequencing of shed virus indicated that there was no loss of attenuation in domain V of the 5'-untranslated region, the primary site of reversion in Sabin OPV. INTERPRETATION We found that the novel OPV2 candidates were safe and immunogenic in IPV-immunised adults, and our data support the further development of these vaccines to potentially be used for maintaining global eradication of neurovirulent type-2 polioviruses. FUNDING Bill & Melinda Gates Foundation.",2019,Both novel OPV2 candidates were immunogenic and increased the median blood titre of serum neutralising antibodies; all participants were seroprotected after vaccination.,"['Participants, who were recruited by local advertising, were adults (aged 18-50 years) in good health who had previously been vaccinated with IPV, and who would not have any contact with immunosuppressed or unvaccinated people for the duration of faecal shedding at the end of the study', 'participants receiving vaccine candidate 1 and 13 (87%) participants receiving vaccine candidate 2', '48 volunteers were screened, of whom 15 (31%) volunteers were excluded for reasons relating to the inclusion or exclusion criteria, three (6%) volunteers were not treated because of restrictions to the number of participants in each group, and 30 (63%) volunteers', 'Between May 22 and Aug 22, 2017', 'isolated participants in a purpose-built containment facility at the University of Antwerp Hospital (Antwerp, Belgium', 'healthy adults']","['vaccine candidate (candidate 1, S2/cre5/S15domV/rec1/hifi3; or candidate 2, S2/S15domV/CpG40', 'novel live attenuated monovalent (serotype 2) oral poliovirus vaccines', 'vaccine', 'oral live-attenuated polio vaccines (OPV), and injected inactivated polio vaccines (IPV']","['median blood titre of serum neutralising antibodies', 'median shedding index', 'severe events', 'serious adverse events', 'blood creatinine phosphokinase', 'incidence and type of serious and severe adverse events, the proportion of participants showing viral shedding in their stools, the time to cessation of viral shedding, the cell culture infective dose of shed virus in virus-positive stools, and a combined index of the prevalence, duration, and quantity of viral shedding', 'Total shedding', 'safety and immunogenicity']","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture Techniques'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",48.0,0.0947478,Both novel OPV2 candidates were immunogenic and increased the median blood titre of serum neutralising antibodies; all participants were seroprotected after vaccination.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium. Electronic address: pierre.vandamme@uantwerpen.be.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'De Coster', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Ananda S', 'Initials': 'AS', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Revets', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kanchanamala', 'Initials': 'K', 'LastName': 'Withanage', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'De Smedt', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Suykens', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'M Steven', 'Initials': 'MS', 'LastName': 'Oberste', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Weldon', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Sue Ann', 'Initials': 'SA', 'LastName': 'Costa-Clemens', 'Affiliation': 'Institute for Global Health, University of Siena, Siena, Italy.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Clemens', 'Affiliation': 'Global Research in Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Modlin', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Weiner', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Macadam', 'Affiliation': 'National Institute for Biological Standards and Control, Ridge, UK.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Andino', 'Affiliation': 'Department of Microbiology and Immunology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Olen M', 'Initials': 'OM', 'LastName': 'Kew', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Konopka-Anstadt', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Burns', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Konz', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Rahnuma', 'Initials': 'R', 'LastName': 'Wahid', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31279-6'] 989,31302695,Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.,"OBJECTIVE This extension study of the Phase III, randomized, placebo-controlled Belimumab International SLE Study (BLISS)-52 and BLISS-76 studies allowed non-US patients with SLE to continue belimumab treatment, in order to evaluate its long-term safety and tolerability including organ damage accrual. METHODS In this multicentre, long-term extension study (GlaxoSmithKline Study BEL112234) patients received i.v. belimumab every 4 weeks plus standard therapy. Adverse events (AEs) were assessed monthly and safety-associated laboratory parameters were assessed at regular intervals. Organ damage (SLICC/ACR Damage Index) was assessed every 48 weeks. The study continued until belimumab was commercially available, with a subsequent 8-week follow-up period. RESULTS A total of 738 patients entered the extension study and 735/738 (99.6%) received one or more doses of belimumab. Annual incidence of AEs, including serious and severe AEs, remained stable or declined over time. Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study. Eleven deaths occurred (and two during post-treatment follow-up), including one (cardiogenic shock) considered possibly related to belimumab. Laboratory parameters generally remained stable. The mean (s.d.) SLICC/ACR Damage Index score was 0.6 (1.02) at baseline (prior to the first dose of belimumab) and remained stable. At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual. CONCLUSION Belimumab displayed a stable safety profile with no new safety signals. There was minimal organ damage progression over 8 years. TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov, NCT00424476 (BLISS-52), NCT00410384 (BLISS-76), NCT00732940 (BEL112232), NCT00712933 (BEL112234).",2020,"At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual. ","['patients with systemic lupus erythematosus treated with', '738 patients entered the extension study and 735/738 (99.6%) received one or more doses of', 'Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study']","['placebo', 'belimumab']","['Eleven deaths', 'Annual incidence of AEs, including serious and severe AEs', 'SLICC/ACR Damage Index score', 'minimal organ damage progression', 'Organ damage (SLICC/ACR Damage Index', 'Adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",738.0,0.202432,"At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual. ","[{'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.'}, {'ForeName': 'Sandra V', 'Initials': 'SV', 'LastName': 'Navarra', 'Affiliation': 'University of Santo Tomas Hospital, Manila, Philippines.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Levy', 'Affiliation': 'Rio de Janeiro State University, Pedro Ernesto University Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Kerala Institute of Medical Sciences (KIMS), Kerala, India.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Lustine', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Adamkovic', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fettiplace', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Mei-Lun', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Beulah', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez279'] 990,31838009,"Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial.","BACKGROUND Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. METHODS In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. FINDINGS Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41). INTERPRETATION Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors. FUNDING Dutch Cancer Society (KWF Kankerbestrijding).",2020,Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7,"['Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility', 'Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient', 'cancer survivors', 'recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma']","['eHealth application Oncokompas', 'intervention group (access to Oncokompas) or control group (access to Oncokompas']","['patient activation (knowledge, skills, and confidence for self-management', 'Patient activation']","[{'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",2953.0,0.21781,Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7,"[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'van der Hout', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Cornelia F', 'Initials': 'CF', 'LastName': 'van Uden-Kraan', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Holtmaat', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Jansen', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Grard A P', 'Initials': 'GAP', 'LastName': 'Nieuwenhuijzen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Hardillo', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Rotterdam, Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Baatenburg de Jong', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Rotterdam, Netherlands.'}, {'ForeName': 'Nicolette L', 'Initials': 'NL', 'LastName': 'Tiren-Verbeet', 'Affiliation': 'Department of Haematology, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Dirkje W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Medical Oncology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'de Heer', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Cees G', 'Initials': 'CG', 'LastName': 'Schaar', 'Affiliation': 'Department of Internal Medicine, Gelre ziekenhuis, Apeldoorn, Netherlands.'}, {'ForeName': 'Robert-Jan E', 'Initials': 'RE', 'LastName': 'Sedee', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Haaglanden MC, The Hague, Netherlands.'}, {'ForeName': 'Koop', 'Initials': 'K', 'LastName': 'Bosscha', 'Affiliation': 'Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands.'}, {'ForeName': 'Michiel W M', 'Initials': 'MWM', 'LastName': 'van den Brekel', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Japke F', 'Initials': 'JF', 'LastName': 'Petersen', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Department of Hematology, Northwest Clinics, Alkmaar, Netherlands.'}, {'ForeName': 'Jimmie', 'Initials': 'J', 'LastName': 'Honings', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Takes', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Houtenbos', 'Affiliation': 'Department of Hematology, Spaarne Gasthuis, Hoofddorp, Netherlands.'}, {'ForeName': 'Wim T', 'Initials': 'WT', 'LastName': 'van den Broek', 'Affiliation': 'Department of Surgery, St Anna Hospital, Geldrop, Netherlands.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'de Bree', 'Affiliation': 'Department of Head and Neck Surgical Oncology, Utrecht University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jansen', 'Affiliation': 'Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Simone E J', 'Initials': 'SEJ', 'LastName': 'Eerenstein', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'C René', 'Initials': 'CR', 'LastName': 'Leemans', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Lonneke V', 'Initials': 'LV', 'LastName': 'van de Poll-Franse', 'Affiliation': 'Department of Research, Netherlands Comprehensive Cancer Organisation, Eindhoven, Netherlands; Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Netherlands; Center of Research on Psychological and Somatic Disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Irma M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. Electronic address: im.verdonck@amsterdamumc.nl.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30675-8'] 991,31838010,"Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial.","BACKGROUND In hormone receptor-positive, HER2-negative early stage breast cancer, cyclin-dependent kinases 4 and 6 (CDK4/6) inhibition in combination with endocrine therapy could represent an alternative to multiagent chemotherapy. We aimed to evaluate the biological and clinical activity of neoadjuvant ribociclib plus letrozole in the luminal B subtype of early stage breast cancer. METHODS CORALLEEN is a parallel-arm, multicentre, randomised, open-label, phase 2 trial completed across 21 hospitals in Spain. We recruited postmenopausal women (≥18 years) with stage I-IIIA hormone receptor-positive, Eastern Cooperative Oncology Group Performance Status 0-1, HER2-negative breast cancer and luminal B by PAM50 with histologically confirmed, operable primary tumour size of at least 2 cm in diameter as measured by MRI. Patients were randomly assigned (1:1) using a web-based system and permuted blocks of 25 to receive either six 28-days cycles of ribociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily letrozole (oral 2·5 mg/day) or four cycles of doxorubicin (intravenous 60 mg/m 2 ) and cyclophosphamide (intravenous 600 mg/m 2 ) every 21 days followed by weekly paclitaxel (intravenous 80 mg/m 2 ) for 12 weeks. The total duration of the neoadjuvant therapy was 24 weeks. Randomisation was stratified by tumour size and nodal involvement. Samples were prospectively collected at baseline (day 0), day 15, and surgery. The primary endpoint was to evaluate the proportion of patients with PAM50 low-risk-of-relapse (ROR) disease at surgery in the modified intention-to-treat population including all randomly assigned patients who received study drug and had a baseline and at least one post-baseline measurement of ROR score. The PAM50 ROR risk class integrated gene expression data, tumour size, and nodal status to define prognosis. This trial was registered at ClinicalTrials.gov, NCT03248427. FINDINGS Between July 27, 2017 to Dec 7, 2018, 106 patients were enrolled. At baseline, of the 106 patients, 92 (87%) patients had high ROR disease (44 [85%] of 52 in the ribociclib and letrozole group and 48 [89%] of 54 in the chemotherapy group) and 14 (13%) patients had intermediate-ROR disease (eight [15%] and six [11%]). Median follow-up was 200·0 days (IQR 191·2-206·0). At surgery, 23 (46·9%; 95% CI 32·5-61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9-61·5) of 52 patients in the chemotherapy group were low-ROR. The most common grade 3-4 adverse events in the ribociclib plus letrozole group were neutropenia (22 [43%] of 51 patients) and elevated alanine aminotransferase concentrations (ten [20%]). The most common grade 3-4 adverse events in the chemotherapy group were neutropenia (31 [60%] of 52 patients) and febrile neutropenia (seven [13%]). No deaths were observed during the study in either group. INTERPRETATION Our results suggest that some patients with high-risk, early stage, hormone receptor-positive, HER2-negative breast cancer could achieve molecular downstaging of their disease with CDK4/6 inhibitor and endocrine therapy. FUNDING Novartis, Nanostring, Breast Cancer Research Foundation-AACR Career Development Award.",2020,"At surgery, 23 (46·9%; 95% CI 32·5-61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9-61·5) of 52 patients in the chemotherapy group were low-ROR.","['recruited postmenopausal women (≥18 years) with stage', '21 hospitals in Spain', 'Between July 27, 2017 to Dec 7, 2018, 106 patients were enrolled', 'postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN']","['ribociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily letrozole (oral 2·5 mg/day) or four cycles of doxorubicin (intravenous 60 mg/m 2 ) and cyclophosphamide (intravenous 600 mg/m 2 ) every 21 days followed by weekly paclitaxel', 'Ribociclib plus letrozole', 'neoadjuvant ribociclib plus letrozole', 'endocrine therapy', 'ribociclib plus letrozole', 'letrozole', 'chemotherapy']","['elevated alanine aminotransferase concentrations', 'proportion of patients with PAM50 low-risk-of-relapse (ROR) disease', 'high ROR disease', 'low-ROR', 'total duration', 'neutropenia', 'febrile neutropenia', 'deaths', 'intermediate-ROR disease', 'ROR score']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",106.0,0.215267,"At surgery, 23 (46·9%; 95% CI 32·5-61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9-61·5) of 52 patients in the chemotherapy group were low-ROR.","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain. Electronic address: alprat@clinic.cat.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hernando', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario of Valencia, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'González Farré', 'Affiliation': 'Department of Pathology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Fernández', 'Affiliation': 'Department of Pathology, Hospital Germans Trials i Pujol, Badalona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Chic', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'González Farré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital General de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""Department of Medical Oncology, Institut Català d'Oncologia Hospitalet, Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Arumi', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Ferrer', 'Affiliation': 'Department of Medical Oncology, Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Montaño', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Izarzugaza', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart-Cussac', 'Affiliation': 'Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bratos', 'Affiliation': 'Department of Medical Oncology, Centro Oncológico Internacional MD Anderson, Madrid, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'González Santiago', 'Affiliation': 'Department of Medical Oncology, Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Department of Medical Oncology, Consorcio Hospitalario Provincial of Castellón, Castellón de la Plana, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Hoyos', 'Affiliation': 'Department of Medical Oncology, Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Rojas', 'Affiliation': 'Department of Medical Oncology, Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Virizuela', 'Affiliation': 'Department of Medical Oncology, Hospital Virgen de la Macarena, Sevilla, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ortega', 'Affiliation': 'Department of Medical Oncology, Fundación Privada Asil de Granollers, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'Department of Medical Oncology, Complejo Universitario de Santiago de Compostela, Spain.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Céliz', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Villagrasa', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Gavilá', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Instituto Valenciano de Oncología, Valencia, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30786-7'] 992,31838011,"Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent sedation. In several phase 2 studies, olanzapine 5 mg has shown equivalent activity to olanzapine 10 mg and a favourable safety profile in relation to somnolence. We evaluated the efficacy of olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting caused by cisplatin-based chemotherapy. METHODS This was a randomised, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy of olanzapine 5 mg with triplet-combination antiemetic therapy done in 26 hospitals in Japan. Key inclusion criteria were patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with cisplatin (≥50 mg/m 2 ) for the first time, age between 20 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0-2. Eligible patients were randomly assigned (1:1) to receive either oral olanzapine 5 mg or placebo once daily on days 1-4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy). Patients were randomly assigned to interventions by use of a web entry system and the minimisation method with a random component, with sex, dose of cisplatin, and age as factors of allocation adjustment. Patients, medical staff, investigators, and individuals handling data were all masked to treatment assignment. The primary endpoint was the proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications in the delayed phase (24-120 h). All randomly assigned patients who satisfied eligibility criteria received a dose of cisplatin 50 mg/m 2 or more, and at least one study treatment, were included in efficacy analysis. All patients who received any treatment in this study were assessed for safety. This study is registered at UMIN Clinical Trials Registry, number UMIN000024676. FINDINGS Between Feb 9, 2017, and July 13, 2018, 710 patients were enrolled; 356 were randomly assigned to receive olanzapine and 354 were assigned to receive placebo. All eligible patients were observed 120 h after cisplatin initiation. One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses. One patient in the olanzapine group discontinued treatment on day 1 and was excluded from the efficacy analysis. In the delayed phase, the proportion of patients who achieved a complete response was 280 (79% [95% CI 75-83] of 354 patients in the olanzapine group and 231 (66% [61-71] of 351 patients in the placebo group (p<0·0001). One patient had grade 3 constipation and one patient had grade 3 somnolence related to treatment in the olanzapine group. INTERPRETATION Olanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone could be a new standard antiemetic therapy for patients undergoing cisplatin-based chemotherapy. FUNDING Japan Agency for Medical Research and Development.",2020,One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses.,"['patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with', '≥50 mg/m 2 ) for the first time, age between 20 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0-2', 'Between Feb 9, 2017, and July 13, 2018', '26 hospitals in Japan', '710 patients were enrolled; 356', 'patients undergoing cisplatin-based chemotherapy', 'Eligible patients']","['placebo', 'Olanzapine', 'cisplatin', 'olanzapine', 'oral olanzapine 5 mg or placebo once daily on days 1-4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy', 'Olanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone', 'cisplatin-based chemotherapy', 'web entry system and the minimisation method with a random component, with sex, dose of cisplatin', 'dexamethasone', 'Olanzapine 5 mg plus standard antiemetic therapy']","['nausea and vomiting', 'grade 3 somnolence', 'complete response', 'grade 3 constipation', 'nausea and vomiting (J-FORCE', 'proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1597589', 'cui_str': 'olanzapine 5 MG [Zyprexa]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",710.0,0.286863,One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses.,"[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Gynaecologic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan. Electronic address: ma.abe@scchr.jp.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Gynaecology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Mizutani', 'Affiliation': 'Department of Respiratory Medicine, Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan; Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Hoshina', 'Affiliation': 'Data Management Section, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Takako Yanai', 'Initials': 'TY', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Nakashima', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nakao', 'Affiliation': 'Department of Pharmacy, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Takei', 'Affiliation': 'Department of Pharmacy, Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Sadamoto', 'Initials': 'S', 'LastName': 'Zenda', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Mizukami', 'Affiliation': 'Department of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Michiru', 'Initials': 'M', 'LastName': 'Sakurai', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30678-3'] 993,31576437,154 compared to 54 mmol per liter of sodium in intravenous maintenance fluid therapy for adult patients undergoing major thoracic surgery (TOPMAST): a single-center randomized controlled double-blind trial.,"PURPOSE To determine the effects of the sodium content of maintenance fluid therapy on cumulative fluid balance and electrolyte disorders. METHODS We performed a randomized controlled trial of adults undergoing major thoracic surgery, randomly assigned (1:1) to receive maintenance fluids containing 154 mmol/L (Na154) or 54 mmol/L (Na54) of sodium from the start of surgery until their discharge from the ICU, the occurrence of a serious adverse event or the third postoperative day at the latest. Investigators, caregivers and patients were blinded to the treatment. Primary outcome was cumulative fluid balance. Electrolyte disturbances were assessed as secondary endpoints, different adverse events and physiological markers as safety and exploratory endpoints. FINDINGS We randomly assigned 70 patients; primary outcome data were available for 33 and 34 patients in the Na54 and Na154 treatment arms, respectively. Estimated cumulative fluid balance at 72 h was 1369 mL (95% CI 601-2137) more positive in the Na154 arm (p < 0.001), despite comparable non-study fluid sources. Hyponatremia < 135 mmol/L was encountered in four patients (11.8%) under Na54 compared to none under Na154 (p = 0.04), but there was no significantly more hyponatremia < 130 mmol/L (1 versus 0; p = 0.31). There was more hyperchloremia > 109 mmol/L under Na154 (24/35 patients, 68.6%) than under Na54 (4/34 patients, 11.8%) (p < 0.001). The treating clinicians discontinued the study due to clinical or radiographic fluid overload in six patients receiving Na154 compared to one patient under Na54 (excess risk 14.2%; 95% CI - 0.2-30.4%, p = 0.05). CONCLUSIONS In adult surgical patients, sodium-rich maintenance solutions were associated with a more positive cumulative fluid balance and hyperchloremia; hypotonic fluids were associated with mild and asymptomatic hyponatremia.",2019,"(95% CI 601-2137) more positive in the Na154 arm (p < 0.001), despite comparable non-study fluid sources.","['adult patients undergoing major thoracic surgery (TOPMAST', 'adults undergoing major thoracic surgery', 'adult surgical patients']","['54\xa0mmol per liter of sodium', 'maintenance fluids containing 154\xa0mmol/L (Na154) or 54\xa0mmol/L (Na54) of sodium']","['hyponatremia', 'cumulative fluid balance', 'adverse events and physiological markers as safety and exploratory endpoints', 'Estimated cumulative fluid balance', 'Hyponatremia', 'Electrolyte disturbances']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1704431', 'cui_str': 'Disorder of electrolytes (disorder)'}]",70.0,0.634376,"(95% CI 601-2137) more positive in the Na154 arm (p < 0.001), despite comparable non-study fluid sources.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Van Regenmortel', 'Affiliation': 'Department of Intensive Care Medicine, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium. niels.vanregenmortel@uza.be.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hendrickx', 'Affiliation': 'Department of Anesthesiology, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), Clinical Research Center Antwerp, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Baar', 'Affiliation': 'Department of Intensive Care Medicine, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Karolien', 'Initials': 'K', 'LastName': 'Dams', 'Affiliation': 'Department of Intensive Care Medicine, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Van Vlimmeren', 'Affiliation': 'Department of Anesthesiology, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Embrecht', 'Affiliation': 'Department of Anesthesiology, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Wittock', 'Affiliation': 'Department of Anesthesiology, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Hendriks', 'Affiliation': 'Department of Thoracic and Vascular Surgery, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lauwers', 'Affiliation': 'Department of Thoracic and Vascular Surgery, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Van Schil', 'Affiliation': 'Department of Thoracic and Vascular Surgery, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Amaryllis H', 'Initials': 'AH', 'LastName': 'Van Craenenbroeck', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610, Antwerp, Belgium.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Verbrugghe', 'Affiliation': 'Department of Intensive Care Medicine, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Manu L N G', 'Initials': 'MLNG', 'LastName': 'Malbrain', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Brussels (UZB), Laarbeeklaan 101, Jette, 1090, Brussels, Belgium.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Van den Wyngaert', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610, Antwerp, Belgium.'}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Jorens', 'Affiliation': 'Department of Intensive Care Medicine, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}]",Intensive care medicine,['10.1007/s00134-019-05772-1'] 994,31251473,Anatomy Learning from Prosected Cadaveric Specimens Versus Plastic Models: A Comparative Study of Upper Limb Anatomy.,"Human cadaveric prosections are a traditional, effective, and highly appreciated modality of anatomy learning. Plastic models are an alternative teaching modality, though few studies examine their effectiveness in learning of upper limb musculoskeletal anatomy. The purpose of this study is to investigate which modality is associated with a better outcome, as assessed by students' performance on examinations. Overall, 60 undergraduate medical students without previous knowledge of anatomy participated in the study. Students were assigned into two groups. Group 1 attended lectures and studied from cadaveric prosections (n = 30) and Group 2 attended lectures and used plastic models in the laboratory (n = 30). A knowledge assessment, including examination with tag questions (spot test) and written multiple-choice questions, was held after the end of the study. Students' perceptions were also investigated via an anonymous questionnaire. No significant difference in students' performance was observed between the group using prosections and the group using plastic models (32.2 ± 14.7 vs 35.0 ± 14.8, respectively; P = 0.477). Similarly, no statistically significant difference was found regarding students' satisfaction from using each learning modality (P = 0.441). Plastic models may be a valuable supplementary modality in learning upper limb musculoskeletal anatomy, despite their limitations. Easy to use and with no need for maintaining facilities, they are highly appreciated by students and can be useful when preparing for the use of cadaveric specimens.",2020,"No significant difference in students' performance was observed between the group using prosections and the group using plastic models (32.2 ±14.7 vs 35.0 ±14.8, respectively; P = 0.477).",['60 undergraduate medical students without previous knowledge of anatomy participated in the study'],['Anatomy learning from prosected cadaveric specimens versus plastic models'],"[""students' satisfaction"", ""students' performance""]","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0147001,"No significant difference in students' performance was observed between the group using prosections and the group using plastic models (32.2 ±14.7 vs 35.0 ±14.8, respectively; P = 0.477).","[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Mitrousias', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Theofilos S', 'Initials': 'TS', 'LastName': 'Karachalios', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Sokratis E', 'Initials': 'SE', 'LastName': 'Varitimidis', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Natsis', 'Affiliation': 'Department of Anatomy and Surgical Anatomy, School of Medicine, Faculty of Health and Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios L', 'Initials': 'DL', 'LastName': 'Arvanitis', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Aristeidis H', 'Initials': 'AH', 'LastName': 'Zibis', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, University of Thessaly, Larissa, Greece.'}]",Anatomical sciences education,['10.1002/ase.1911'] 995,31800496,Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial.,"OBJECTIVE The aim of this study was to evaluate the safety and feasibility of nonoperative treatment of acute nonperforated appendicitis in children during 5 years of follow-up. METHODS A 4-year follow-up of a previous randomized controlled pilot trial, including 50 children with acute nonperforated appendicitis, was performed. The patients were initially randomized to nonoperative treatment with antibiotics or appendectomy with 1-year follow-up previously reported. Data were extracted from the computerized notes and telephone interviews.The primary outcome was treatment failure, defined as need for a secondary intervention under general anesthesia, related to the previous diagnosis of acute nonperforated appendicitis. RESULTS The children were followed up for at least 5 years [median 5.3 (range 5.0-5.6)] after inclusion. There were no failures in the appendectomy group (0/26) and 11 failures in the nonoperative group (11/24). Nine failures had occurred during the first year after inclusion, 2 of whom had histologically confirmed appendicitis. There were 2 further patients with recurrent acute appendicitis 1 to 5 years after inclusion. Both these patients had uncomplicated laparoscopic appendectomies for histologically confirmed acute appendicitis. There were no losses to follow-up. CONCLUSIONS At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%). Treatment with antibiotics seems to be safe in the intermediate-term; none of the children previously treated nonoperatively re-presented with complicated appendicitis.",2020,"At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%).","['Acute Nonperforated Appendicitis in Children', '50 children with acute nonperforated appendicitis, was performed', 'acute nonperforated appendicitis in children during 5 years of follow-up']","['antibiotics', 'antibiotics or appendectomy', 'nonoperative treatment', 'Nonoperative Treatment Versus Appendectomy']","['recurrent acute appendicitis', 'safety and feasibility', 'acute appendicitis', 'treatment failure, defined as need for a secondary intervention under general anesthesia, related to the previous diagnosis of acute nonperforated appendicitis']","[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439589', 'cui_str': 'Recurrent acute (qualifier value)'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0162643'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis (contextual qualifier) (qualifier value)'}]",50.0,0.117108,"At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%).","[{'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Patkova', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Svenningsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Almström', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'Surgery Unit, UCL Institute of Child Health, London, United Kingdom, Department of Pediatric Surgery, Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Wester', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Svensson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",Annals of surgery,['10.1097/SLA.0000000000003646'] 996,31322974,Suboptimal Engagement of High-Level Cortical Regions Predicts Random-Noise-Related Gains in Sustained Attention.,"Interindividual variability in outcomes across individuals poses great challenges for the application of noninvasive brain stimulation in psychological research. Here, we examined how the effects of high-frequency transcranial random-noise stimulation (tRNS) on sustained attention varied as a function of a well-studied electrocortical marker: spontaneous theta:beta ratio. Seventy-two participants received sham, 1-mA, and 2-mA tRNS in a double-blind, crossover manner while they performed a sustained-attention task. Receiving 1-mA tRNS was associated with improved sustained attention, whereas the effect of 2-mA tRNS was similar to the effect of sham tRNS. Furthermore, individuals' baseline theta:beta ratio moderated the effects of 1-mA tRNS and provided explanatory power beyond baseline behavioral performance. The tRNS-related effects on sustained attention were also accompanied by reductions in theta:beta ratio. These findings impart novel insights into mechanisms underlying tRNS effects and emphasize how designing studies that link variability in cognitive outcomes to variability in neurophysiology can improve inferential power in neurocognitive research.",2019,"Furthermore, individuals' baseline theta:beta ratio moderated the effects of 1-mA tRNS and provided explanatory power beyond baseline behavioral performance.",[],"['high-frequency transcranial random-noise stimulation (tRNS', 'sham, 1-mA, and 2-mA tRNS']",['sustained attention'],[],"[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1172076', 'cui_str': '1-(PE)-MA'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}]",72.0,0.155692,"Furthermore, individuals' baseline theta:beta ratio moderated the effects of 1-mA tRNS and provided explanatory power beyond baseline behavioral performance.","[{'ForeName': 'Siobhán', 'Initials': 'S', 'LastName': 'Harty', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, University of Oxford.'}, {'ForeName': 'Roi', 'Initials': 'R', 'LastName': 'Cohen Kadosh', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, University of Oxford.'}]",Psychological science,['10.1177/0956797619856658'] 997,31291491,The role of high-intensity focused ultrasound as a symptomatic treatment for Parkinson's disease.,"MR-guided focused ultrasound is a novel, minimally invasive surgical procedure for symptomatic treatment of PD. With this technology, the ventral intermediate nucleus, STN, and internal globus pallidus have been targeted for therapeutic cerebral ablation, while also minimizing the risk of hemorrhage and infection from more invasive neurosurgical procedures. In a double-blinded, prospective, sham-controlled randomized controlled trial of MR-guided focused ultrasound thalamotomy for treatment of tremor-dominant PD, 62% of treated patients demonstrated improvement in tremor scores from baseline to 3 months postoperatively, as compared to 22% in the sham group. There has been only one open-label trial of MR-guided focused ultrasound subthalamotomy for patients with PD, demonstrating improvements of 71% for rigidity, 36% for akinesia, and 77% for tremor 6 months after treatment. Among the two open-label trials of MR-guided focused ultrasound pallidotomy for patients with PD, dyskinesia and overall motor scores improved up to 52% and 45% at 6 months postoperatively. Although MR-guided focused ultrasound thalamotomy is now approved by the U.S. Food and Drug Administration for treatment of parkinsonian tremor, additional high-quality randomized controlled trials are warranted and are underway to determine the safety and efficacy of MR-guided focused ultrasound subthalamotomy and pallidotomy for treatment of the cardinal features of PD. These studies will be paramount to aid clinicians to determine the ideal ablative target for individual patients. Additional work will be required to assess the durability of MR-guided focused ultrasound lesions, ideal timing of MR-guided focused ultrasound ablation in the course of PD, and the safety of performing bilateral lesions. © 2019 International Parkinson and Movement Disorder Society.",2019,"There has been only one open-label trial of MR-guided focused ultrasound subthalamotomy for patients with PD, demonstrating improvements of 71% for rigidity, 36% for akinesia, and 77% for tremor 6 months after treatment.","[""Parkinson's disease""]","['MR-guided focused ultrasound pallidotomy', 'MR-guided focused ultrasound thalamotomy', 'MR-guided focused ultrasound']","['dyskinesia and overall motor scores', 'tremor scores']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0195893', 'cui_str': 'Pallidotomy'}, {'cui': 'C0195894', 'cui_str': 'Thalamotomy (procedure)'}]","[{'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",,0.0535059,"There has been only one open-label trial of MR-guided focused ultrasound subthalamotomy for patients with PD, demonstrating improvements of 71% for rigidity, 36% for akinesia, and 77% for tremor 6 months after treatment.","[{'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Moosa', 'Affiliation': 'Department of Neurological Surgery, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Martínez-Fernández', 'Affiliation': 'CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur, CEU-San Pablo University, Móstoles, Madrid, Spain.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Elias', 'Affiliation': 'Department of Neurological Surgery, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Alamo', 'Affiliation': 'CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur, CEU-San Pablo University, Móstoles, Madrid, Spain.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Eisenberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Fishman', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27779'] 998,31274710,FOVEA-SPARING VERSUS COMPLETE INTERNAL LIMITING MEMBRANE PEELING IN VITRECTOMY FOR THE TREATMENT OF MACULAR HOLES.,"PURPOSE To compare the anatomical and functional outcomes of vitrectomy involving complete internal limiting membrane peeling (CP) with those of vitrectomy involving fovea-sparing internal limiting membrane peeling (FSP) for the treatment of macular holes measuring >250 µm. METHODS This prospective, randomized, comparative study included 46 eyes with a medium or large macular hole that was randomized to undergo complete (CP group) or fovea-sparing (FSP group) internal limiting membrane peeling during vitrectomy. The main outcome measures included the foveal retinal sensitivity, visual acuity, and central retinal thickness. RESULTS Both groups showed significantly improved foveal retinal sensitivity after surgery; the mean foveal retinal sensitivity change at 12 months after surgery was +2.8 ± 2.1 dB in the CP group and +7.2 ± 2.3 dB in the FSP group. The visual acuity also showed a significant improvement in both groups, with no significant differences in values at any time point. Regarding central retinal thickness, there was a significant decrease in the CP group and no change in the FSP group. Nicks or dimples in the inner retinal layers were visible in the fovea and perifovea of nine eyes in the CP group. CONCLUSION Our findings suggest that both CP and FSP are safe and effective treatments leading to functional and anatomical improvements in patients with all size macular holes. However, the fovea-sparing technique may provide better functional outcomes because of a greater improvement in foveal retinal sensitivity.",2020,"Nicks or dimples in the inner retinal layers were visible in the fovea and perifovea of nine eyes in the CP group. ","['patients with all size macular holes', '46 eyes with a medium or large macular hole that was randomized to']","['vitrectomy involving complete internal limiting membrane peeling (CP', 'undergo complete (CP group) or fovea-sparing (FSP group) internal limiting membrane peeling during vitrectomy', 'vitrectomy involving fovea-sparing internal limiting membrane peeling (FSP', 'CP and FSP']","['foveal retinal sensitivity', 'visual acuity', 'mean foveal retinal sensitivity change', 'central retinal thickness', 'foveal retinal sensitivity, visual acuity, and central retinal thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",46.0,0.0427441,"Nicks or dimples in the inner retinal layers were visible in the fovea and perifovea of nine eyes in the CP group. ","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morescalchi', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Bahja', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gambicorti', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cancarini', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Department of Health Sciences, Eye Clinic, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002612'] 999,32127178,Randomized control trial of opioid- versus nonopioid-based analgesia after thyroidectomy.,"BACKGROUND Opioid-based analgesia is the most common method for pain control in the postoperative period. Limited data exist to compare the adequacy of pain control in the post thyroidectomy period with nonopioid-based analgesia. We aimed to evaluate the efficacy of nonopioid-based, postoperative analgesia. METHODS After institutional review board approval, patients were randomized to 1 of 2 pain control regimens. Sample size was calculated to assess for a pain score difference of 1 based on a visual analog scale. The control group received opioid-based, postoperative analgesia, whereas the study group received nonopioid-based analgesia of acetaminophen and ibuprofen. Pain scores (measured on visual analog scale) and opioid use (converted to morphine equivalent dose) were measured after completion of the operation. RESULTS The sample sizes for the study and control groups were 49 and 46 patients, respectively. The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference. Morphine equivalent opioid requirement for pain control in the postoperative period was 0.8 vs 6.9 mg (P < .01), respectively. CONCLUSION In a randomized control trial, we showed that patients treated with nonopioid analgesia had similar pain scores to those treated with opioids, with the benefit of having lower opioid exposure in the perioperative period.",2020,"The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference.",[],"['nonopioid-based analgesia of acetaminophen and ibuprofen', 'opioid-based, postoperative analgesia', 'opioid- versus nonopioid-based analgesia after thyroidectomy', 'nonopioid analgesia', 'Morphine']","['pain score', 'pain control', 'pain scores', 'Pain scores']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",,0.118298,"The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference.","[{'ForeName': 'Vardan', 'Initials': 'V', 'LastName': 'Papoian', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC. Electronic address: vpapoian@gmail.com.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Handy', 'Affiliation': 'Department of Anesthesiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Villano', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Tolentino', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Mohamed T', 'Initials': 'MT', 'LastName': 'Hassanein', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Nosanov', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Felger', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}]",Surgery,['10.1016/j.surg.2020.01.011'] 1000,31233129,Effect of Drug Disposal Bag Provision on Proper Disposal of Unused Opioids by Families of Pediatric Surgical Patients: A Randomized Clinical Trial.,"Importance Although opioids are an important component of pain management for children recovering from surgery, postoperative opioid prescribing has contributed to the current opioid crisis in the United States because these medications are often prescribed in excess and are rarely properly disposed. One potential strategy to combat opioid misuse is to remove excess postoperative opioids from circulation by providing patients with drug disposal products that enable safe disposal of opioids in the home garbage. Objective To determine whether the provision of a drug disposal bag increases proper opioid disposal among the families of pediatric patients undergoing ambulatory surgery. Design, Setting, and Participants This randomized clinical trial enrolled 202 parents or guardians of children 1 to 17 years of age who underwent otolaryngologic or urologic surgery at the outpatient surgery centers of a tertiary children's hospital in Columbus, Ohio, from June to December 2018 and who received an opioid prescription prior to discharge. Interventions Families randomized to intervention were provided a drug disposal bag containing activated charcoal and instructions for use plus standard postoperative discharge instructions on opioid use, storage, and disposal. Families in standard care arm received standard postoperative discharge instructions only. All participants completed a baseline survey and a follow-up survey 2 to 4 weeks postoperatively. Main Outcomes and Measures Primary outcome was proper opioid disposal, defined as disposal using a drug disposal bag or a disposal method recommended by the US Food and Drug Administration. Results Of 202 parents or guardians enrolled, 181 completed follow-up (92 in intervention arm and 89 in standard care arm). Most patients in both groups were white (75 [73.5%] vs 79 [80.6%]) and male (63 [61.2%] vs 54 [54.6%]), and the median (interquartile range) age was 6 (5-9) years in the intervention arm and 7 (6-10) years in the standard care arm. For intention-to-treat analyses, 92 families receiving a disposal bag and 89 families not receiving a disposal bag were included. Among them, 66 families (71.7%) randomized to receive a disposal bag reported properly disposing of their child's opioids, whereas 50 parents (56.2%) who did not receive a disposal bag reported proper opioid disposal (difference in proportions, 15.5%; 95% CI, 1.7%-29.3%; P = .03). Among only those families who filled an opioid prescription and had leftover opioids after resolution of their child's pain, 66 of 77 parents or guardians (85.7%) who had received a disposal bag and 50 of 77 parents or guardians (64.9%) who had received standard care reported properly disposing of their child's opioids (difference in proportions, 20.8%; 95% CI, 7.6%-34.0%). Conclusions and Relevance Results of this study indicated that providing drug disposal bags to families of children receiving postoperative opioids increased the likelihood of excess opioid disposal. Greater availability of disposal products may complement ongoing prescribing reduction efforts aimed at decreasing opioid misuse. Trial Registration ClinicalTrials.gov identifier: NCT03575377.",2019,"To determine whether the provision of a drug disposal bag increases proper opioid disposal among the families of pediatric patients undergoing ambulatory surgery. ","[""202 parents or guardians of children 1 to 17 years of age who underwent otolaryngologic or urologic surgery at the outpatient surgery centers of a tertiary children's hospital in Columbus, Ohio, from June to December 2018 and who received an opioid prescription prior to discharge"", '202 parents or guardians enrolled', '92 families receiving a disposal bag and 89 families not receiving a disposal bag were included', 'Unused Opioids by Families of Pediatric Surgical Patients', 'pediatric patients undergoing ambulatory surgery']","['drug disposal bag containing activated charcoal and instructions for use plus standard postoperative discharge instructions', 'standard postoperative discharge instructions only', 'Drug Disposal Bag Provision']","['opioid disposal, defined as disposal using a drug disposal bag or a disposal method recommended by the US Food and Drug Administration']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1321139', 'cui_str': 'Same day surgery center'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0001275', 'cui_str': 'medicinal charcoal'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0948693', 'cui_str': 'Post procedural drainage'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}]",202.0,0.109924,"To determine whether the provision of a drug disposal bag increases proper opioid disposal among the families of pediatric patients undergoing ambulatory surgery. ","[{'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Lawrence', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Carsel', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Leonhart', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Holden W', 'Initials': 'HW', 'LastName': 'Richards', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Calista M', 'Initials': 'CM', 'LastName': 'Harbaugh', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Waljee', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'McLeod', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Walz', 'Affiliation': ""Department of Otolaryngology, Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Minneci', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Deans', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Cooper', 'Affiliation': ""Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.1695'] 1001,31715440,Long-term naturalistic follow-up of chronic pain in adults with prescription opioid use disorder.,"BACKGROUND Chronic pain is common in patients with prescription opioid use disorder (OUD), and pain severity has been shown to predict opioid use for those with chronic pain. However, recent research suggests that focusing on pain status (i.e., the presence or absence of chronic pain) at treatment initiation may not reflect the clinical significance of pain over the long-term course of OUD. Reports of variability in chronic pain and its clinical significance over time have yet to be investigated in patients with prescription OUD. The present study examined variability in chronic pain status from entry into prescription OUD treatment through 3.5-year follow-up. Additionally, we examined the association between concurrent chronic pain and opioid use at three follow-up time points. METHODS This secondary analysis (N = 309) of a national, randomized, controlled trial of prescription OUD treatment used generalized estimating equations to assess variability in the prevalence of chronic pain from study entry to 3.5-year follow-up, and the association between chronic pain status and concurrent opioid use. RESULTS Fifty-three percent of participants reported variability in chronic pain status over time. The prevalence of chronic pain decreased from study entry through follow-up (aOR = 0.47, p < 0.001). Chronic pain was associated with increased opioid use at each follow-up assessment (aOR = 3.56, p < 0.001). CONCLUSIONS Chronic pain status may vary over time in those with prescription OUD, and chronic pain appears to be associated with concurrent opioid use. The present findings highlight the importance of assessing chronic pain throughout the course of prescription OUD.",2019,"The prevalence of chronic pain decreased from study entry through follow-up (aOR = 0.47, p < 0.001).","['patients with prescription opioid use disorder (OUD', 'adults with prescription opioid use disorder', 'patients with prescription OUD']",['prescription OUD treatment used generalized estimating equations'],"['prevalence of chronic pain', 'Chronic pain', 'chronic pain status', 'chronic pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",309.0,0.0785515,"The prevalence of chronic pain decreased from study entry through follow-up (aOR = 0.47, p < 0.001).","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'McDermott', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychology, Florida State University, Tallahassee, FL 32304, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Griffin', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': 'Laboratory for Psychiatric Biostatistics, McLean Hospital, Belmont, MA 02478, USA; Department of Biostatistics, Harvard School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Jamison', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Provost', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA. Electronic address: rweiss@mclean.harvard.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107675'] 1002,31208393,"Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: a randomized, blinded, multicenter clinical trial.","BACKGROUND This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). METHODS This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. RESULTS At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by - 6.60 for CN and - 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by - 13.03 ± 19.63 for CN and - 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation. CONCLUSIONS The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. TRIAL REGISTRATION KCT0002180 , retrospectively registered on 23 December 2016.",2019,"The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups.","['retrospectively registered on 23 December 2016', 'A total of 153 DED patients', 'dry eye patients']","['cyclosporine (CN) and 3% diquafosol (DQ', 'CN', 'cyclosporine and 3% diquafosol solution']","['Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score', 'safety evaluation', 'level of improvement regarding NEI, TBUT, and OSDI scores', 'mean instillation frequency of CN', 'NEI scaled scores', 'TBUT and Schirmer values for CN', 'Mean OSDI score differences']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C1955479', 'cui_str': ""diuridine 5'-(pentahydrogen tetraphosphate) tetrasodium salt""}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0222045'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",153.0,0.221216,"The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups.","[{'ForeName': 'Chang Hyun', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 10, 63-ro, Yeongdeungpo-gu, Seoul, 07345, Republic of Korea.""}, {'ForeName': 'Hyung Keun', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Mee Kum', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Chul', 'Initials': 'EC', 'LastName': 'Kim', 'Affiliation': ""Department of Ophthalmology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Im', 'Initials': 'TI', 'LastName': 'Kim', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hong Kyun', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Jong Suk', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Chul', 'Initials': 'KC', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Do Hyung', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chul Young', 'Initials': 'CY', 'LastName': 'Choi', 'Affiliation': 'Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 10, 63-ro, Yeongdeungpo-gu, Seoul, 07345, Republic of Korea. sara514@catholic.ac.kr.""}]",BMC ophthalmology,['10.1186/s12886-019-1136-8'] 1003,31138732,Acute Effects of Oscillatory PEP and Thoracic Compression on Secretion Removal and Impedance of the Respiratory System in Non-Cystic Fibrosis Bronchiectasis.,"BACKGROUND Bronchiectasis is characterized by abnormal and permanent dilatation of the bronchi, caused mainly by the progression of inflammatory processes and loss of the ability to remove mucus. Techniques to clear the airways are essential for the treatment of these patients. In this study, we aimed to evaluate the acute effects of oscillatory PEP and thoracic compression on both the clearance of secretions and impedance of airways in subjects with bronchiectasis. METHODS This was a randomized crossover single-blinded study that involved both subjects with bronchiectasis and healthy subjects evaluated by using an impulse oscillometry system, which assessed resistance at 5 Hz and resistance 20 Hz, reactance at 5 Hz, reactance area, and resonant frequency, before, after, and 30 min after oscillatory PEP, chest compression, or control sessions. Dry and total weights, adhesiveness, purulence of the expectorated secretions, the dyspnea scale score, the acceptability and tolerance scale score, pulse oximetry, and difficulty in expectoration were also assessed. RESULTS The dry and total weights of secretions were higher after the use of the oscillatory PEP technique than those in a control session ( P = .005 and P = .039, respectively). In the bronchiectasis group, there was a decrease after oscillatory PEP in total airway resistance ( P = .04), peripheral resistance ( P = .005), and reactance area ( P = .001). After compression, there was a decrease in peripheral resistance Hz ( P = .001) and reactance area ( P = .001). In the healthy group, there was an increase in resistance at 5 Hz ( P = .02) after oscillatory PEP. There were no differences in acceptability and tolerance, dyspnea, and oxygen saturation. CONCLUSIONS The oscillatory PEP technique was effective for the removal of secretions and in decreasing total and peripheral respiratory system resistance; thoracic compression had comparable positive effects on the peripheral resistance. Both techniques were safe and well tolerated by the subjects with bronchiectasis. ClinicalTrials.gov registration NCT02509637.).",2019,"In the healthy group, there was an increase in resistance at 5 Hz ( P = .02) after oscillatory PEP.","['subjects with bronchiectasis and healthy subjects', 'subjects with bronchiectasis', 'Non-Cystic Fibrosis Bronchiectasis']","['oscillatory PEP and thoracic compression', 'Oscillatory PEP and Thoracic Compression']","['acceptability and tolerance, dyspnea, and oxygen saturation', 'safe and well tolerated', 'peripheral resistance Hz', 'peripheral resistance', 'dry and total weights of secretions', 'Secretion Removal and Impedance of the Respiratory System', 'Dry and total weights, adhesiveness, purulence of the expectorated secretions, the dyspnea scale score, the acceptability and tolerance scale score, pulse oximetry, and difficulty in expectoration', 'resistance at 5 Hz', 'oscillatory PEP in total airway resistance']","[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C3541375', 'cui_str': 'RESPIRATORY SYSTEM'}, {'cui': 'C0001515', 'cui_str': 'Adhesiveness'}, {'cui': 'C0854358', 'cui_str': 'Purulence'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0232024', 'cui_str': 'Total airway resistance (observable entity)'}]",,0.0323122,"In the healthy group, there was an increase in resistance at 5 Hz ( P = .02) after oscillatory PEP.","[{'ForeName': 'Letícia Helena', 'Initials': 'LH', 'LastName': 'de Souza Simoni', 'Affiliation': 'Department of Health Science, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Daniele Oliveira', 'Initials': 'DO', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Health Science, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Hugo Celso Dutra', 'Initials': 'HCD', 'LastName': 'de Souza', 'Affiliation': 'Department of Health Science, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Baddini-Martinez', 'Affiliation': 'Internal Medicine Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Marcel Koenigkam', 'Initials': 'MK', 'LastName': 'Santos', 'Affiliation': 'Internal Medicine Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Ada Clarice', 'Initials': 'AC', 'LastName': 'Gastaldi', 'Affiliation': 'Department of Health Science, University of São Paulo, Ribeirão Preto, Brazil. ada@fmrp.usp.br.'}]",Respiratory care,['10.4187/respcare.06025'] 1004,31867145,Two-Year Follow-up of a Sequential Mixed-Mode Experiment in the U.S. National Monitoring the Future Study.,"This study examines the two-year follow up (data collected in 2016 at modal age 21/22) of an original mixed-mode longitudinal survey experiment (data collected at modal age 19/20 in 2014). The study compares participant retention in the experimental conditions to retention in the standard Monitoring the Future (MTF) control condition (participants who completed an in-school baseline survey in 12 th grade in 2012 or 2013 and were selected to participate in the first follow-up survey by mail in 2014, N =2,451). A supplementary sample who completed the 12 th grade baseline survey in 2012 or 2013 but were not selected to participate in the main MTF follow-up ( N =4,950) were recruited and randomly assigned to one of three experimental conditions: 1: Mail Push, 2: Web Push, 3: Web Push + Email in 2014 and again in 2016. Results from the first experiment indicated that Condition 3 (Web Push + Email) was promising based on similar response rates and lower costs (Patrick et al. 2018). The current study examines how experimental condition and type of 2014 response were associated with response in 2016, the extent to which response mode and device type changed from 2014 to 2016, and cumulative cost comparisons across conditions. Results indicated that responding via web in 2014 was associated with greater odds of participation again in 2016 regardless of condition; respondents tended to respond in the same mode although the ""push"" condition did move respondents toward web over paper; device type varied between waves; and the cumulative cost savings of Web Push + Email grew larger compared to the MTF Control. The web push strategy is therefore promising for maintaining respondent engagement while reducing cost.",2019,"The study compares participant retention in the experimental conditions to retention in the standard Monitoring the Future (MTF) control condition (participants who completed an in-school baseline survey in 12 th grade in 2012 or 2013 and were selected to participate in the first follow-up survey by mail in 2014, N =2,451).","['participants who completed an in-school baseline survey in 12 th grade in 2012 or 2013 and were selected to participate in the first follow-up survey by mail in 2014, N =2,451', 'two-year follow up (data collected in 2016 at modal age 21/22) of an original mixed-mode longitudinal survey experiment (data collected at modal age 19/20 in 2014', 'A supplementary sample who completed the 12 th grade baseline survey in 2012 or 2013 but were not selected to participate in the main MTF follow-up ( N =4,950']",['standard Monitoring the Future (MTF) control condition'],['cumulative cost savings'],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0086569', 'cui_str': 'Longitudinal Survey'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",2016.0,0.0218921,"The study compares participant retention in the experimental conditions to retention in the standard Monitoring the Future (MTF) control condition (participants who completed an in-school baseline survey in 12 th grade in 2012 or 2013 and were selected to participate in the first follow-up survey by mail in 2014, N =2,451).","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Mick P', 'Initials': 'MP', 'LastName': 'Couper', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Bohyun Joy', 'Initials': 'BJ', 'LastName': 'Jang', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Laetz', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Schulenberg', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lloyd D', 'Initials': 'LD', 'LastName': 'Johnston', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Bachman', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': ""O'Malley"", 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan.'}]",Survey practice,['10.29115/SP-2019-0003'] 1005,31233135,Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial.,"Importance Many patients receive suboptimal rehabilitation therapy doses after stroke owing to limited access to therapists and difficulty with transportation, and their knowledge about stroke is often limited. Telehealth can potentially address these issues. Objectives To determine whether treatment targeting arm movement delivered via a home-based telerehabilitation (TR) system has comparable efficacy with dose-matched, intensity-matched therapy delivered in a traditional in-clinic (IC) setting, and to examine whether this system has comparable efficacy for providing stroke education. Design, Setting, and Participants In this randomized, assessor-blinded, noninferiority trial across 11 US sites, 124 patients who had experienced stroke 4 to 36 weeks prior and had arm motor deficits (Fugl-Meyer [FM] score, 22-56 of 66) were enrolled between September 18, 2015, and December 28, 2017, to receive telerehabilitation therapy in the home (TR group) or therapy at an outpatient rehabilitation therapy clinic (IC group). Primary efficacy analysis used the intent-to-treat population. Interventions Participants received 36 sessions (70 minutes each) of arm motor therapy plus stroke education, with therapy intensity, duration, and frequency matched across groups. Main Outcomes and Measures Change in FM score from baseline to 4 weeks after end of therapy and change in stroke knowledge from baseline to end of therapy. Results A total of 124 participants (34 women and 90 men) had a mean (SD) age of 61 (14) years, a mean (SD) baseline FM score of 43 (8) points, and were enrolled a mean (SD) of 18.7 (8.9) weeks after experiencing a stroke. Among those treated, patients in the IC group were adherent to 33.6 of the 36 therapy sessions (93.3%) and patients in the TR group were adherent to 35.4 of the 36 assigned therapy sessions (98.3%). Patients in the IC group had a mean (SD) FM score change of 8.36 (7.04) points from baseline to 30 days after therapy (P < .001), while those in the TR group had a mean (SD) change of 7.86 (6.68) points (P < .001). The covariate-adjusted mean FM score change was 0.06 (95% CI, -2.14 to 2.26) points higher in the TR group (P = .96). The noninferiority margin was 2.47 and fell outside the 95% CI, indicating that TR is not inferior to IC therapy. Motor gains remained significant when patients enrolled early (<90 days) or late (≥90 days) after stroke were examined separately. Conclusions and Relevance Activity-based training produced substantial gains in arm motor function regardless of whether it was provided via home-based telerehabilitation or traditional in-clinic rehabilitation. The findings of this study suggest that telerehabilitation has the potential to substantially increase access to rehabilitation therapy on a large scale. Trial Registration ClinicalTrials.gov identifier: NCT02360488.",2019,"Motor gains remained significant when patients enrolled early (<90 days) or late (≥90 days) after stroke were examined separately. ","['Adults', '124 participants (34 women and 90 men) had a mean (SD) age of 61 (14) years, a mean (SD) baseline FM score of 43 (8) points, and were enrolled a mean (SD) of 18.7 (8.9) weeks after experiencing a stroke', '124 patients who had experienced stroke 4 to 36 weeks prior and had arm motor deficits (Fugl-Meyer [FM] score, 22-56 of 66) were enrolled between September 18, 2015, and December 28, 2017, to receive']","['Home-Based Telerehabilitation vs In-Clinic Therapy', 'telerehabilitation therapy in the home (TR group) or therapy at an outpatient rehabilitation therapy clinic (IC group', 'suboptimal rehabilitation therapy', 'arm movement delivered via a home-based telerehabilitation (TR) system']","['covariate-adjusted mean FM score change', 'stroke knowledge', 'FM score', 'mean (SD) FM score change', 'Motor gains']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",124.0,0.226829,"Motor gains remained significant when patients enrolled early (<90 days) or late (≥90 days) after stroke were examined separately. ","[{'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Cramer', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dodakian', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Vu', 'Initials': 'V', 'LastName': 'Le', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'See', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Augsburger', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McKenzie', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Nina L', 'Initials': 'NL', 'LastName': 'Chiu', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Heckhausen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Cassidy', 'Affiliation': 'Department of Neurology, University of California, Irvine.'}, {'ForeName': 'Walt', 'Initials': 'W', 'LastName': 'Scacchi', 'Affiliation': 'Institute for Software Research, University of California, Irvine.'}, {'ForeName': 'Megan Therese', 'Initials': 'MT', 'LastName': 'Smith', 'Affiliation': 'Department of Statistics, University of California, Irvine.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Barrett', 'Affiliation': 'Department of Stroke Rehabilitation Research, Kessler Foundation, West Orange, New Jersey.'}, {'ForeName': 'Jayme', 'Initials': 'J', 'LastName': 'Knutson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Brain Stimulation and Robotics Laboratory, Burke Neurological Institute, White Plains, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Putrino', 'Affiliation': 'Department of Telemedicine and Virtual Rehabilitation, Burke Medical Research Institute, White Plains, New York.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Agrawal', 'Affiliation': 'Department of Clinical Neurosciences, University of California, San Diego, La Jolla.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngo', 'Affiliation': 'Brooks Rehabilitation Clinical Research Center, Brooks Rehabilitation, Jacksonville, Florida.'}, {'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Roth', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Tirschwell', 'Affiliation': 'Department of Neurology, University of Washington, Seattle.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Woodbury', 'Affiliation': 'Department of Health Science and Research, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Zafonte', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, Massachusetts.'}, {'ForeName': 'Wenle', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Spilker', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Wolf', 'Affiliation': 'Division of Physical Therapy Education, Department of Rehabilitation Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.1604'] 1006,31894444,Pathways for HIV Prevention Behaviors Following a Home-Based Couples Intervention for Pregnant Women and Male Partners in Kenya.,"Pregnancy is a time of heightened HIV risk, but also a phase when a couple can prioritize family health. We conducted secondary analysis of a home-based intervention in rural Kenya to explore couple-level adherence to HIV prevention behaviors. The intervention included health education, relationship-building skills, and Couples HIV Testing and Counseling. Pregnant women were randomized to the intervention (n = 64) or standard care (n = 63) along with male partners. Of 96 couples, 82 (85.0%) were followed to 3 months postpartum, when 31.0% of couples reported perfect adherence to HIV prevention. In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32). A structural equation model found the intervention had moderate effects on couple communication, large effects on couple efficacy to take action around HIV, which in turn improved HIV prevention behaviors (CFI = 0.969; TLI = 0.955; RMSEA = 0.049). Strengthening couple communication and efficacy may help prevent the spread of HIV to infants or partners around the time of pregnancy.",2020,"In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32).","['rural Kenya to explore couple-level adherence to HIV prevention\xa0behaviors', 'Pregnant women', 'Pregnant Women and Male Partners in Kenya']","['Home-Based Couples Intervention', 'standard care']","['HIV prevention behaviors', 'health education, relationship-building skills, and Couples HIV Testing and Counseling']","[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018701'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",96.0,0.0433479,"In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32).","[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'Division of HIV/AIDS, Department of Medicine, University of California, 995 Potrero Avenue, Building 80, San Francisco, CA, 94110, USA. hatchera@globalhealth.ucsf.edu.'}, {'ForeName': 'Lynae', 'Initials': 'L', 'LastName': 'Darbes', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Kwena', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Musoke', 'Affiliation': 'Department of Global Health and Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Anna Joy', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Global Health and Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Owino', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Anderson', 'Affiliation': 'Sparkman Center for Global Health, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Oyaro', 'Affiliation': 'Research Care and Training Programme, Family AIDS Care and Educational Services, Kisumu, Kenya.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02774-4'] 1007,31943605,Comparison of three-dimensional and 4K imaging systems in novice surgeons: a cross-over study.,"BACKGROUND Laparoscopy has revolutionized the surgical field with the advent of minimally invasive techniques leading to smaller surgical wounds, enhanced recovery, early discharge from the hospital and early return to work. Since the initiation of three-dimensional (3D) systems, studies have failed to prove significant advantages over traditional two-dimensional systems which could be attributed to suboptimal image quality, poor illumination and high cost of earlier systems. Recent advances in stereoscopy have led to the introduction of high-definition (HD) systems with improvement in image quality in both two-dimensional and 3D systems. With HD and new 4K imaging system, the previous data are now obsolete. METHODS We devised a cross-over study using the Olympus 4K camera imaging system compared with the HD 3D systems using 40 novice surgeons with no prior surgical skills to perform standardized surgical tasks and the groups were crossed over to assess any difference in the learning curve with the imaging systems. RESULTS The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle. The time taken to perform those tasks was comparable except in knot tying where there was significant reduction in the time taken to tie knots with a P-value of <0.001 in both groups. CONCLUSION The study showed no significant difference in the time to perform tasks. The precision of the tasks was significantly improved with the 3D systems.",2020,"The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle.","['40 novice surgeons with no prior surgical skills', 'novice surgeons']",[],"['time to perform tasks', 'precision of the tasks']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",40.0,0.0235963,"The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle.","[{'ForeName': 'Abdullah Muhammad', 'Initials': 'AM', 'LastName': 'Rana', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Abdul Ahad', 'Initials': 'AA', 'LastName': 'Rana', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hewett', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}]",ANZ journal of surgery,['10.1111/ans.15653'] 1008,31218911,Fluoxetine in progressive multiple sclerosis: The FLUOX-PMS trial.,"BACKGROUND Preclinical studies suggest that fluoxetine has neuroprotective properties that might reduce axonal degeneration in multiple sclerosis (MS). OBJECTIVE To determine whether fluoxetine slows accumulation of disability in progressive MS. METHODS In a double-blind multicenter phase 2 trial, patients with primary or secondary progressive MS were randomized to fluoxetine 40 mg/day or placebo for a period of 108 weeks. Clinical assessments were performed every 12 weeks by trained study nurses who visited the patients at their home. The primary outcome was the time to a 12-week confirmed 20% increase in the Timed 25 Foot Walk or 9-Hole Peg test. Secondary outcomes included the Hauser ambulation index, cognitive tests, fatigue, and brain magnetic resonance imaging (MRI). RESULTS In the efficacy analysis, 69 patients received fluoxetine and 68 patients received placebo. Using the log-rank test ( p  = 0.258) and Cox regression analysis ( p  = 0.253), we found no significant difference in the primary outcome between the two groups. Due to an unexpected slow rate of progression in the placebo group, there was insufficient statistical power to detect a potential benefit of fluoxetine. We found no differences between the two groups for secondary outcomes. CONCLUSION The trial failed to demonstrate a neuroprotective effect of fluoxetine in patients with progressive MS.",2019,"We found no differences between the two groups for secondary outcomes. ","['patients with progressive MS', '69 patients received', 'patients with primary or secondary progressive MS', 'progressive multiple sclerosis']","['fluoxetine', 'fluoxetine 40\u2009mg/day or placebo', 'placebo', 'Fluoxetine']","['Timed 25 Foot Walk or 9-Hole', 'Hauser ambulation index, cognitive tests, fatigue, and brain magnetic resonance imaging (MRI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1592239', 'cui_str': 'Fluoxetine 40 MG [Prozac]'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",,0.0766187,"We found no differences between the two groups for secondary outcomes. ","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Cambron', 'Affiliation': 'Department of Neurology, UZ Brussel, Brussel, Belgium/Center for Neurosciences (C4N) Vrije Universiteit Brussel (VUB), Brussels, Belgium/ Department of Neurology, AZ Sint-Jan, Bruges, Belgium.'}, {'ForeName': 'Jop', 'Initials': 'J', 'LastName': 'Mostert', 'Affiliation': 'Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': ""D'Hooghe"", 'Affiliation': 'Department of Neurology, UZ Brussel, Brussel, Belgium/Center for Neurosciences (C4N) Vrije Universiteit Brussel (VUB), Brussels, Belgium/Nationaal MS Centrum Melsbroek, Steenokkerzeel, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Nagels', 'Affiliation': 'Department of Neurology, UZ Brussel, Brussel, Belgium/Center for Neurosciences (C4N) Vrije Universiteit Brussel (VUB), Brussels, Belgium/Nationaal MS Centrum Melsbroek, Steenokkerzeel, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Willekens', 'Affiliation': 'Department of Neurology, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Debruyne', 'Affiliation': 'Department of Neurology, University Hospital Gent, Gent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Algoed', 'Affiliation': 'Department of Neurology, AZ Maria Middelares, Gent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Verhagen', 'Affiliation': 'Department of Neurology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hupperts', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Heersema', 'Affiliation': 'Department of Neurology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'De Keyser', 'Affiliation': 'Department of Neurology, UZ Brussel, Brussel, Belgium/Center for Neurosciences (C4N) Vrije Universiteit Brussel (VUB), Brussels, Belgium/ Department of Neurology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519843051'] 1009,31246237,"Association Between Change in Visual Acuity and Change in Central Subfield Thickness During Treatment of Diabetic Macular Edema in Participants Randomized to Aflibercept, Bevacizumab, or Ranibizumab: A Post Hoc Analysis of the Protocol T Randomized Clinical Trial.","Importance The determination of optical coherence tomography (OCT) central subfield thickness (CST) is an objective measure, and visual acuity (VA) is a subjective measure. Therefore, using OCT CST changes as a surrogate for VA changes in diabetic macular edema seems reasonable. However, studies suggest that change in OCT CST following anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema is correlated with changes in VA but varies substantially among individuals, and so may not be a good surrogate for changes in VA. Objective To determine associations between changes in VA and changes in OCT CST across 3 anti-VEGF agents (aflibercept, bevacizumab, or ranibizumab) used in a randomized clinical trial for diabetic macular edema. Design, Setting, and Participants Post hoc analyses were conducted of DRCR Retina Network Protocol T among 652 of 660 participants (98.8%) meeting inclusion criteria for this investigation. The study was conducted between August 22, 2012, and September 23, 2015. The post hoc data collection and analysis were performed from May 29 to July 11, 2018. Interventions Six monthly intravitreous anti-VEGF injections (unless success was achieved after 3-5 months) were administered; subsequent injections or focal/grid laser photocoagulation treatments were given as needed per protocol to achieve stability. Main Outcomes and Measures Association between changes in VA letter score with changes in CST at 12, 52, and 104 weeks after randomization to aflibercept, bevacizumab, or ranibizumab. Results Of the 652 participants, 304 were women (46.6%); median age was 61 years (interquartile range, 54-67 years). The correlation between CST and VA at the follow-up visits was 0.24 (95% CI, 0.16-0.31) in 616 patients at 12 weeks, 0.31 (95% CI, 0.24-0.38) in 609 patients at 52 weeks, and 0.23 (95% CI, 0.15-0.31) in 566 patients at 104 weeks. The correlation coefficients of change in VA vs change in OCT CST for these time intervals were 0.36 (95% CI, 0.29-0.43) at 12 weeks, 0.36 (95% CI, 0.29-0.43) at 52 weeks, and 0.33 (95% CI, 0.26-0.41) at 104 weeks. Conclusions and Relevance Changes in CST appear to account for only a small proportion of the total variation in changes in VA. These findings do not support using changes in OCT CST as a surrogate for changes in VA in phase 3 clinical trials evaluating anti-VEGF for diabetic macular edema or as a guide to inform the physician or patient about changes in VA after anti-VEGF treatment. Trial Registration ClinicalTrials.gov identifier: NCT01627249.",2019,"The correlation coefficients of change in VA vs change in OCT CST for these time intervals were 0.36 (95% CI, 0.29-0.43) at 12 weeks, 0.36 (95% CI, 0.29-0.43) at 52 weeks, and 0.33 (95% CI, 0.26-0.41) at 104 weeks. ","[' 304 were women (46.6%); median age was 61 years (interquartile range, 54-67 years', '652 participants', 'diabetic macular edema', 'August 22, 2012, and September 23, 2015']","['intravitreous anti-VEGF injections', 'OCT CST', 'VEGF agents (aflibercept, bevacizumab, or ranibizumab', 'aflibercept, bevacizumab', 'optical coherence tomography (OCT) central subfield thickness (CST', 'Aflibercept, Bevacizumab, or Ranibizumab']",['Visual Acuity and Change in Central Subfield Thickness'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",304.0,0.312687,"The correlation coefficients of change in VA vs change in OCT CST for these time intervals were 0.36 (95% CI, 0.29-0.43) at 12 weeks, 0.36 (95% CI, 0.29-0.43) at 52 weeks, and 0.33 (95% CI, 0.26-0.41) at 104 weeks. ","[{'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Isoken', 'Initials': 'I', 'LastName': 'Odia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mathew W', 'Initials': 'MW', 'LastName': 'MacCumber', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rosberger', 'Affiliation': 'MaculaCare, New York, New York.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.1963'] 1010,31112442,In-Clinic and Standalone Internet Cognitive Behavior Therapy Treatment for Social Anxiety in Stuttering: A Randomized Trial of iGlebe.,"Purpose iGlebe is an individualized, fully automated Internet cognitive behavior therapy (CBT) treatment program that requires no clinician contact. Phase I and II trials have demonstrated that it may be efficacious for treating the social anxiety commonly associated with stuttering. The present trial sought to establish whether the outcomes achieved by iGlebe are noninferior to those associated with in-clinic CBT from clinical psychologists. Method Fifty adults with stuttering were randomized to receive in-clinic CBT for anxiety or 5 months online access to iGlebe. The design was a noninferiority randomized controlled trial with outcomes assessed at prerandomization and at 6 and 12 months postrandomization. Primary outcomes were CIDI-Auto-2.1 diagnoses for anxiety and mood disorders and Brief Fear of Negative Evaluation scale scores ( Carleton, McCreary, Norton, & Asmundson, 2006 ). Secondary outcomes included speech, psychology, and quality-of-life measures. Results Outcomes consistently showed clinically significant improvements of around a medium effect size for the cohort as a whole from prerandomization to 6 months postrandomization, which were maintained at 12 months postrandomization. Comparisons between the 2 treatments showed little difference between iGlebe and in-clinic treatment for all primary and secondary outcomes, with last observation carried forward for missing data. Conclusions iGlebe is a promising individualized treatment for social anxiety for adults who stutter and offers a viable and inexpensive alternative to in-clinic CBT with clinical psychologists. An issue to emerge from this trial, which requires clarification during future clinical trials of iGlebe, is the posttreatment relation between percentage of syllables stuttered and self-reported stuttering severity ratings.",2019,"Comparisons between the 2 treatments showed little difference between iGlebe and in-clinic treatment for all primary and secondary outcomes, with last observation carried forward for missing data.","['Social Anxiety in Stuttering', 'Method Fifty adults with stuttering']","['Standalone Internet Cognitive Behavior Therapy Treatment', 'clinic CBT']","['CIDI-Auto-2.1 diagnoses for anxiety and mood disorders and Brief Fear of Negative Evaluation scale scores ( Carleton, McCreary, Norton, & Asmundson, 2006 ', 'speech, psychology, and quality-of-life measures']","[{'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",50.0,0.056176,"Comparisons between the 2 treatments showed little difference between iGlebe and in-clinic treatment for all primary and secondary outcomes, with last observation carried forward for missing data.","[{'ForeName': 'Ross G', 'Initials': 'RG', 'LastName': 'Menzies', 'Affiliation': 'Australian Stuttering Research Centre, The University of Sydney, New South Wales.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Packman', 'Affiliation': 'Australian Stuttering Research Centre, The University of Sydney, New South Wales.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Onslow', 'Affiliation': 'Australian Stuttering Research Centre, The University of Sydney, New South Wales.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': ""O'Brian"", 'Affiliation': 'Australian Stuttering Research Centre, The University of Sydney, New South Wales.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Fjóla Dögg', 'Initials': 'FD', 'LastName': 'Helgadóttir', 'Affiliation': 'Australian Stuttering Research Centre, The University of Sydney, New South Wales.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-S-18-0340'] 1011,31792949,The effect of a low-dose naloxone infusion on the incidence of respiratory depression after intrathecal morphine administration for major open hepatobiliary surgery: a randomised controlled trial.,"Intrathecal morphine is an analgesic option for major hepatopancreaticobiliary procedures but is associated with a risk of respiratory depression. We hypothesised that a postoperative low-dose naloxone infusion would reduce the incidence of respiratory depression without an increase in pain scores. Patients scheduled for major open hepatopancreaticobiliary surgery and who were receiving 10 μg.kg -1 intrathecal morphine were eligible for inclusion. Patients were allocated randomly to receive a postoperative infusion of naloxone 5 μg.kg -1 .h -1 (naloxone group) or saline at an identical infusion rate (control group) until the morning after surgery. Clinicians, nursing staff and patients were blinded to group allocation. The primary outcome measure was the incidence of respiratory depression (respiratory rate < 10 breaths.min -1 and/or oxygen saturation < 90%). Secondary outcome measures included: arterial partial pressure of carbon dioxide; pain score; requirement for supplemental analgesic; and incidence of nausea and vomiting, pruritus and sedation. In total, data from 95 patients (48 in the naloxone group and 47 in the control group) were analysed. The incidence of respiratory depression was lower in the naloxone group compared with the control group (10/48 vs. 21/47 patients, respectively; p = 0.037, relative risk 0.47 (95%CI 0.25-0.87). Maximum pain scores were greater for patients allocated to the naloxone group compared with control (median 5 (95%CI 4-6) vs. 4 (95%CI 2-4), respectively; p < 0.001). A low-dose naloxone infusion decreases the incidence of respiratory depression following intrathecal morphine administration in patients having major hepatopancreaticobiliary surgery at the expense of a small increase in postoperative pain.",2020,"Maximum pain scores were greater for patients allocated to the naloxone group compared with control (median 5 (95%CI 4-6) vs. 4 (95%CI 2-4), respectively; p < 0.001).","['95 patients (48 in the naloxone group and 47 in the control group) were analysed', 'major open hepatobiliary surgery', 'Patients scheduled for major open hepatopancreaticobiliary surgery and who were receiving 10', 'patients having major hepatopancreaticobiliary surgery']","['Intrathecal morphine', 'intrathecal morphine', 'naloxone infusion', 'naloxone group) or saline', 'naloxone', 'naloxone 5\xa0μg.kg -1 .h -1']","['respiratory depression', 'pain scores', 'postoperative pain', 'arterial partial pressure of carbon dioxide; pain score; requirement for supplemental analgesic; and incidence of nausea and vomiting, pruritus and sedation', 'incidence of respiratory depression', 'Maximum pain scores', 'incidence of respiratory depression (respiratory rate <\xa010 breaths.min -1 and/or oxygen saturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",,0.429976,"Maximum pain scores were greater for patients allocated to the naloxone group compared with control (median 5 (95%CI 4-6) vs. 4 (95%CI 2-4), respectively; p < 0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cosgrave', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vencken', 'Affiliation': 'Clinical Research Centre, University College Dublin, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Galligan', 'Affiliation': 'Clinical Research Centre, University College Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soukhin', 'Affiliation': 'Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'McMullan', 'Affiliation': 'Department of Anaesthesia, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Liver transplantation and cardiac anaesthesia, Kings College Hospital NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Puttappa', 'Affiliation': 'Department of Anaesthesia, Addenbrookes Hospital, Cambridge University Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boylan', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hussain', 'Affiliation': ""Clinical Research Centre, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Conlon', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': ""Department of Intensive Care Medicine, St. Vincent's University Hospital, Dublin, Ireland.""}]",Anaesthesia,['10.1111/anae.14931'] 1012,31227804,Fatty acid regio-specificity of triacylglycerol molecules may affect plasma lipid responses to dietary fats-a randomised controlled cross-over trial.,"BACKGROUND/OBJECTIVES Hypercholesterolaemic effects of saturated fatty acids (SFA) may be influenced not only by the chain length, but also by their specific location within the triacylglycerol (TAG) molecule. We examined the hypothesis that dietary fats rich in SFA, but containing mostly unsaturated fatty acids in the sn-2 position with most SFA in sn-1 and -3 (palm olein [PO] and cocoa butter [CB]) will have similar serum lipid outcomes to unsaturated olive oil (OO). SUBJECTS/METHODS Thirty-eight participants (20-40 yr, 18.5- ≤ 27.5 kg/m 2 ) completed a 4-week randomised 3 × 3 crossover feeding intervention, preceded by 2-week run-in and separated by 2-week washout periods. Background diet contained 35 percentage of total energy (%E) fat, 18%E protein, 48%E carbohydrates, differing in test fats only (palm olein (PO), CB, OO; 20%E). Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions, were assessed pre- and post-intervention. Data were analysed using mixed effects longitudinal models with a P-value < 0.05 considered significant. RESULTS Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB. No differences were seen for TC/HDL-C (mean [95%CI] change for PO, 0.08[0.00, 0.15] mmol/L; CB, 0.06 [-0.05, 0.16] mmol/L; and OO, -0.01 [-0.15, 0.13] mmol/L; P = 0.53] or any other parameter including LDL sub-fractions. OO decreased IDL-A compared to PO (-2.2 [-4.31, -0.21] mg/dL, P = 0.03). CONCLUSION In healthy young participants, plasma lipid responses to PO and CB, enriched in SFA but having primarily unsaturated fatty acid in the sn-2 position of TAG, did not differ from OO.",2020,"RESULTS Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","['Thirty-eight participants (20-40\u2009yr, 18.5-\u2009≤\u200927.5', 'healthy young participants']",['saturated fatty acids (SFA'],"['plasma fatty acids', 'plasma lipid responses', 'TC/HDL-C', 'OO and C18:0', 'Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",38.0,0.0699815,"RESULTS Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","[{'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia. welma.stonehouse@csiro.au.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'James-Martin', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mahinda', 'Initials': 'M', 'LastName': 'Abeywardena', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0452-7'] 1013,31784904,Bioprofiles and mechanistic pathways associated with Cheyne-Stokes respiration: insights from the SERVE-HF trial.,"INTRODUCTION The SERVE-HF trial included patients with heart failure and reduced ejection fraction (HFrEF) with sleep-disordered breathing, randomly assigned to treatment with Adaptive-Servo Ventilation (ASV) or control. The primary outcome was the first event of death from any cause, lifesaving cardiovascular intervention, or unplanned hospitalization for worsening heart failure. A subgroup analysis of the SERVE-HF trial suggested that patients with Cheyne-Stokes respiration (CSR) < 20% (low CSR) experienced a beneficial effect from ASV, whereas in patients with CSR ≥ 20% ASV might have been harmful. Identifying the proteomic signatures and the underlying mechanistic pathways expressed in patients with CSR could help generating hypothesis for future research. METHODS Using a large set of circulating protein-biomarkers (n = 276, available in 749 patients; 57% of the SERVE-HF population) we sought to investigate the proteins associated with CSR and to study the underlying mechanisms that these circulating proteins might represent. RESULTS The mean age was 69 ± 10 years and > 90% were male. Patients with CSR < 20% (n = 139) had less apnoea-hypopnea index (AHI) events per hour and less oxygen desaturation. Patients with CSR < 20% might have experienced a beneficial effect of ASV treatment (primary outcome HR [95% CI] = 0.55 [0.34-0.88]; p = 0.012), whereas those with CSR ≥ 20% might have experienced a detrimental effect of ASV treatment (primary outcome HR [95% CI] = 1.39 [1.09-1.76]; p = 0.008); p for interaction = 0.001. Of the 276 studied biomarkers, 8 were associated with CSR (after adjustment and with a FDR1%-corrected p value). For example, higher PAR-1 and ITGB2 levels were associated with higher odds of having CSR < 20%, whereas higher LOX-1 levels were associated with higher odds of CSR ≥ 20%. Signalling, metabolic, haemostatic and immunologic pathways underlie the expression of these biomarkers. CONCLUSION We identified proteomic signatures that may represent underlying mechanistic pathways associated with patterns of CSR in HFrEF. These hypothesis-generating findings require further investigation towards better understanding of CSR in HFrEF. SUMMARY OF THE FINDINGS PAR-1 proteinase-activated receptor 1, ADM adrenomedullin, HSP-27 heat shock protein-27, ITGB2 integrin beta 2, GLO1 glyoxalase 1, ENRAGE/S100A12 S100 calcium-binding protein A12, LOX-1 lectin-like LDL receptor 1, ADAM-TS13 disintegrin and metalloproteinase with a thrombospondin type 1 motif, member13 also known as von Willebrand factor-cleaving protease.",2020,"For example, higher PAR-1 and ITGB2 levels were associated with higher odds of having CSR < 20%, whereas higher LOX-1 levels were associated with higher odds of CSR ≥ 20%.","['patients with heart failure and reduced ejection fraction (HFrEF) with sleep-disordered breathing', 'patients with CSR', 'The mean age was 69\u2009±\u200910\xa0years and\u2009>\u200990% were male']",['Adaptive-Servo Ventilation (ASV) or control'],"['LOX-1 levels', 'first event of death from any cause, lifesaving cardiovascular intervention, or unplanned hospitalization for worsening heart failure', 'apnoea-hypopnea index (AHI) events per hour and less oxygen desaturation', 'PAR-1 and ITGB2 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4285752', 'cui_str': 'Adaptive support ventilation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",749.0,0.0442647,"For example, higher PAR-1 and ITGB2 levels were associated with higher odds of having CSR < 20%, whereas higher LOX-1 levels were associated with higher odds of CSR ≥ 20%.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Centre d'Investigation Clinique Inserm, CHU, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, INSERM CIC-P 1433, CHRU de Nancy, INSERM U1116, FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), 4, rue du Morvan, 54500, Vandoeuvre-les-Nancy, France.""}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Duarte', 'Affiliation': ""Centre d'Investigation Clinique Inserm, CHU, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, INSERM CIC-P 1433, CHRU de Nancy, INSERM U1116, FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), 4, rue du Morvan, 54500, Vandoeuvre-les-Nancy, France.""}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Woehrle', 'Affiliation': 'ResMed Science Center, ResMed Germany Inc, Martinsried, Germany.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Cowie', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Angermann', 'Affiliation': 'Department of Medicine and Comprehensive Heart Failure Center, University Hospital and University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Marie-Pia', 'Initials': 'MP', 'LastName': ""d'Ortho"", 'Affiliation': 'University Paris Diderot, Sorbonne Paris Cité, Hôpital Bichat, Explorations Fonctionnelles, DHU FIRE, AP-HP, Paris, France.'}, {'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Erdmann', 'Affiliation': 'Heart Center, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Levy', 'Affiliation': 'University of Grenoble Alpes, Inserm, HP2 lab, Grenoble, France.'}, {'ForeName': 'Anita K', 'Initials': 'AK', 'LastName': 'Simonds', 'Affiliation': 'Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Virend K', 'Initials': 'VK', 'LastName': 'Somers', 'Affiliation': 'Mayo Clinic and Mayo Foundation, Rochester, MN, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Teschler', 'Affiliation': 'Department of Pneumology, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bresso', 'Affiliation': 'Université de Lorraine, CNRS, Inria, LORIA, Nancy, 54500, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Dominique-Devignes', 'Affiliation': 'Université de Lorraine, CNRS, Inria, LORIA, Nancy, 54500, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Centre d'Investigation Clinique Inserm, CHU, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, INSERM CIC-P 1433, CHRU de Nancy, INSERM U1116, FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), 4, rue du Morvan, 54500, Vandoeuvre-les-Nancy, France.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Centre d'Investigation Clinique Inserm, CHU, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, INSERM CIC-P 1433, CHRU de Nancy, INSERM U1116, FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), 4, rue du Morvan, 54500, Vandoeuvre-les-Nancy, France. f.zannad@chru-nancy.fr.""}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-019-01578-9'] 1014,31190958,Postoperative pain control after the use of dexmedetomidine and propofol to sedate patients undergoing ankle surgery under spinal anesthesia: a randomized controlled trial.,"Background: Dexmedetomidine is widely used for conscious sedation in patients undergoing lower-extremity surgery under regional anesthesia. We evaluated the postoperative analgesic effects of intravenous dexmedetomidine given during ankle surgery under spinal anesthesia. Methods: Forty-three participants underwent repair of lateral angle ligaments under spinal anesthesia. For sedation during surgery, participants were allocated to a dexmedetomidine group (n=22) that received a loading dose of 1 mcg.kg -1 over 10 min, followed by a maintenance dose of 0.2-0.7 μg.kg -1 .h -1 ; and a propofol group (n=21) that received an effective site concentration of 0.5-2.0 μg.mL -1 via target-controlled infusion. The primary outcome was the postoperative, cumulative, intravenous (IV) morphine equivalent dose delivered via IV patient-controlled anesthesia (PCA) and rescue analgesic consumption in the first 24 h after surgery. We recorded sensory and motor block durations. Results: The postoperative IV morphine equivalent dose was 14.5 mg (0.75-31.75 mg) in the dexmedetomidine group compared to 48.0 mg (31.5-92.5 mg) in the propofol group (median difference, 33.2 mg; 95% confidence interval, 21.0-54.8 mg; P <0.001). The time to the first complaint of surgical site pain was significantly prolonged in the dexmedetomidine group ( P <0.001), but the duration of motor block was comparable between the two groups ( P =0.55). Conclusion: IV dexmedetomidine given as a sedative during ankle surgery under spinal anesthesia reduced postoperative opioid consumption in the first 24 h. Thus, intraoperative dexmedetomidine is a versatile sedative adjunct. Level of evidence: Level I, prospective randomized trial.",2019,"The time to the first complaint of surgical site pain was significantly prolonged in the dexmedetomidine group ( P <0.001), but the duration of motor block was comparable between the two groups ( P =0.55). ","['patients undergoing lower-extremity surgery under regional anesthesia', 'ankle surgery under spinal anesthesia', 'sedate patients undergoing ankle surgery under spinal anesthesia']","['dexmedetomidine and propofol', 'Dexmedetomidine', 'propofol', 'repair of lateral angle ligaments under spinal anesthesia', 'dexmedetomidine']","['postoperative opioid consumption', 'Postoperative pain control', 'postoperative, cumulative, intravenous (IV) morphine equivalent dose delivered via IV patient-controlled anesthesia (PCA) and rescue analgesic consumption', 'duration of motor block', 'postoperative analgesic effects', 'time to the first complaint of surgical site pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",43.0,0.526576,"The time to the first complaint of surgical site pain was significantly prolonged in the dexmedetomidine group ( P <0.001), but the duration of motor block was comparable between the two groups ( P =0.55). ","[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Seon', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Huigyeong', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ki-Sun', 'Initials': 'KS', 'LastName': 'Sung', 'Affiliation': 'Department of Orthopedics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Soo Joo', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Mi Sook', 'Initials': 'MS', 'LastName': 'Gwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gaab Soo', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae Soo', 'Initials': 'TS', 'LastName': 'Hahm', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Justin Sangwook', 'Initials': 'JS', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Journal of pain research,['10.2147/JPR.S195745'] 1015,31734510,An artificial tear containing flaxseed oil for treating dry eye disease: A randomized controlled trial.,"PURPOSE To evaluate the efficacy and safety of a nano-emulsion artificial tear (OM3) containing carboxymethylcellulose (CMC) and glycerin, flaxseed oil and castor oil, and three osmoprotectants (levocarnitine, erythritol, and trehalose) compared with an artificial tear (Refresh Optive Advanced [ROA]) containing the same ingredients with the exception of trehalose and flaxseed oil. METHODS In this multicenter, double-masked, randomized, two-arm, parallel-group, 6-visit study (screening, baseline, and days 7, 30, 60, and 90), subjects with dry eye disease underwent an open-label, 7-day run-in with CMC 0.5% (Refresh Plus), before 1:1 randomization to OM3 or ROA for 90 days (both instilled ≥2 daily). Ocular Surface Disease Index (OSDI; primary endpoint change from baseline at day 90), tear film breakup time (TBUT), and ocular staining (combined/corneal/conjunctival) were assessed; change from baseline in these parameters was calculated at each timepoint. Treatment-related adverse events (AEs) were assessed at each visit. RESULTS Overall, 242 subjects were randomized (OM3, n = 120; ROA, n = 122). At day 90, significant improvements in OSDI, ocular staining and TBUT were evident in both treatment groups. Significant (P < 0.05) between-group differences in favor of OM3 were observed for combined ocular staining (all timepoints), corneal staining (day 90), and conjunctival staining (day 30). Treatment-related AEs were higher in the ROA (9.8%) versus OM3 (6.7%) group; blurred vision was among the most commonly reported AE (OM3 0% vs ROA 4.1%). CONCLUSION These findings support the application of OM3, a novel preservative-free, nano-emulsion tear formulation with trehalose and flaxseed oil, for the treatment of dry eye disease.",2020,"< 0.05) between-group differences in favor of OM3 were observed for combined ocular staining (all timepoints), corneal staining (day 90), and conjunctival staining (day 30).","['242 subjects were randomized (OM3, n\u202f=\u202f120; ROA, n\u202f=\u202f122']","['artificial tear containing flaxseed oil', 'OM3 or ROA', 'nano-emulsion artificial tear (OM3) containing carboxymethylcellulose (CMC) and glycerin, flaxseed oil and castor oil, and three osmoprotectants (levocarnitine, erythritol, and trehalose) compared with an artificial tear (Refresh Optive Advanced [ROA', 'subjects with dry eye disease underwent an open-label, 7-day run-in with CMC 0.5% (Refresh Plus']","['OSDI, ocular staining and TBUT', 'OM3', 'efficacy and safety', 'blurred vision', 'tear film breakup time (TBUT), and ocular staining (combined/corneal/conjunctival', 'Ocular Surface Disease Index']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0023754', 'cui_str': 'flaxseed oil'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0007068', 'cui_str': 'thylose'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0007343', 'cui_str': 'Castor Oil'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0014757', 'cui_str': 'Erythritol'}, {'cui': 'C0040815', 'cui_str': 'Trehalose'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",242.0,0.0609629,"< 0.05) between-group differences in favor of OM3 were observed for combined ocular staining (all timepoints), corneal staining (day 90), and conjunctival staining (day 30).","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Downie', 'Affiliation': 'Department of Optometry and Vision Sciences, University of Melbourne, Parkville, VIC, Australia. Electronic address: ldownie@unimelb.edu.au.'}, {'ForeName': 'Milton M', 'Initials': 'MM', 'LastName': 'Hom', 'Affiliation': 'Canyon City Eyecare, Azusa, CA, USA.'}, {'ForeName': 'Gregg J', 'Initials': 'GJ', 'LastName': 'Berdy', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA; Ophthalmology Associates, St. Louis, MO, USA.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'El-Harazi', 'Affiliation': 'Lugene Eye Institute, Glendale, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Verachtert', 'Affiliation': 'Moyes Eye Center, Kansas City, MO, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'University of New South Wales, School of Optometry and Vision Science, Sydney, Australia.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Allergan Plc, Irvine, CA, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Carlisle-Wilcox', 'Affiliation': 'Allergan Plc, Irvine, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Simmons', 'Affiliation': 'University of New South Wales, School of Optometry and Vision Science, Sydney, Australia; Allergan Plc, Irvine, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vehige', 'Affiliation': 'Allergan Plc, Irvine, CA, USA.'}]",The ocular surface,['10.1016/j.jtos.2019.11.004'] 1016,31672172,Changes in pain following an interaction period of resistance training and green tea extract consumption in sedentary hypertensive women: impact of blood pressure swings.,"BACKGROUND Changes in blood pressure (BP) may affect pain. However, the interaction effect of resistance training and green tea on BP and pain has not been studied. The primary aim of this study was to evaluate the impact of resistance training and green tea extract (GTE) on pain variables in hypertensive patients. Secondary aim included determining the effects of BP alterations on pain responses. METHODS In a randomized, double-blind, placebo-controlled study, 30 middle-aged sedentary women were randomly divided into resistance training and green tea extract (GR, n = 8), resistance training (R, n = 8), green tea (G, n = 7), and control groups (C, n = 7). The study period consisted of 3 weeks of GTE (~ 245 mg total polyphenols) consumption twice a day followed by 6 weeks of interaction with resistance training. GR and R groups performed two circuits of training with ten repetitions at 50% of 1RM 2 days a week while other two groups had no any regular exercise training. R and C groups also received placebo capsules (maltodextrin) with the same timing. Pain threshold and perception, BP, and heart rate were recorded following the first and last session of training at rest and 5th and 15th minute. RESULTS Pain perception of training groups after the last session was significantly higher than control conditions, and at this time, the magnitude of BP responses was lower in training groups. In proportion to pain threshold, there were no significant differences between groups. CONCLUSION It seems that training-induced hypotension can alter pain perception in hypertensive women through changes in baroreceptor activation.",2019,"RESULTS Pain perception of training groups after the last session was significantly higher than control conditions, and at this time, the magnitude of BP responses was lower in training groups.","['sedentary hypertensive women', 'hypertensive women', 'hypertensive patients', '30 middle-aged sedentary women']","['resistance training and green tea extract consumption', 'regular exercise training', 'resistance training and green tea extract (GR, n\u2009=\u20098), resistance training (R, n\u2009=\u20098), green tea', 'GTE (~\u2009245\u2009mg total polyphenols) consumption twice a day followed by 6\xa0weeks of interaction with resistance training', 'placebo', 'placebo capsules (maltodextrin', 'training-induced hypotension', 'resistance training and green tea extract (GTE', 'resistance training and green tea']","['pain responses', 'Pain perception', 'pain variables', 'BP responses', 'BP and pain', 'blood pressure (BP', 'pain perception', 'Pain threshold and perception, BP, and heart rate']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1384640', 'cui_str': 'Green Tea'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.110919,"RESULTS Pain perception of training groups after the last session was significantly higher than control conditions, and at this time, the magnitude of BP responses was lower in training groups.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Arazi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, P.O.Box: 1438, Rasht, Iran. hamidarazi@yahoo.com.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Taati', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, P.O.Box: 1438, Rasht, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Kheirkhah', 'Affiliation': 'Department of Cardiology, Healthy Heart Research Center, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Ramezanpour', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, P.O.Box: 1438, Rasht, Iran.'}]","Journal of health, population, and nutrition",['10.1186/s41043-019-0188-y'] 1017,31785587,Kinetics of oxytocin effects on amygdala and striatal reactivity vary between women and men.,"Accumulating evidence suggests that intranasal oxytocin (OXT; 24 IU) reduces amygdala responses to fear-related stimuli in men, while exerting inverse effects in women. However, OXT enhances activity of the brain reward system in both sexes. Importantly, a crucial and still open question is whether there are sex-specific dose-response relationships for the amygdala and striatal regions. To address this question, a total of 90 healthy women participated in a double-blind, placebo-controlled crossover functional magnetic resonance imaging (fMRI) study and the results were compared with our previous findings from men. Participants were randomly assigned to three doses of OXT (6 IU, 12 IU, and 24 IU) and completed an emotional face recognition task including fearful and happy faces of varying emotional intensities. Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women. While treatment effects on amygdala reactivity were evident at each given dose, the OXT effect on striatal responses to social stimuli was more pronounced with higher doses, but this dose-dependent effect did not survive correction for multiple comparisons. Importantly, OXT effects on amygdala and striatal activation significantly differed between sexes and striatal baseline sexual-dimorphic response patterns were diminished after administration of OXT. Our findings suggest that OXT increases the salience of social signals by strengthening the sensitivity for these signals in the amygdala and in the striatum in women, while OXT may primarily induce anxiolysis by reducing amygdala responses in men.",2020,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","['90 healthy women participated in a double-blind', 'women and men']","['OXT', 'placebo-controlled crossover functional magnetic resonance imaging (fMRI', 'oxytocin', 'intranasal oxytocin (OXT', 'placebo', 'emotional face recognition task including fearful and happy faces of varying emotional intensities']","['amygdala reactivity', 'amygdala and striatal reactivity', 'OXT effects on amygdala and striatal activation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",90.0,0.234159,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lieberz', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany. Dirk-Scheele@gmx.de.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Institute for Psychology, University of Freiburg, 79104, Freiburg, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Matheisen', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Lìa', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kinfe', 'Affiliation': 'Department of Neurosurgery, Division of Functional Neurosurgery and Stereotaxy, Friedrich-Alexander University (FAU) Erlangen-Nürnberg, 91054, Erlangen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0582-6'] 1018,31774519,Follow-up of Intervention to Prevent Dental Caries Among Indigenous Children in Australia: A Secondary Analysis of a Randomized Clinical Trial.,"Importance For an intervention delivered in early childhood to have meaningful translational effect, long-term follow-up is necessary, especially among underserved indigenous children among whom preventable dental disease is common. Objectives To test the long-term effectiveness of an early-childhood dental intervention through a follow-up at age 5 years among Aboriginal children in Australia. Design, Setting, and Participants This secondary analysis of a randomized clinical trial followed up on participants of the Baby Teeth Talk Study, a 2-group parallel, outcome assessor-blinded, randomized clinical trial conducted among Aboriginal children in South Australia, Australia. Participants included 448 mother or caregiver-child dyads who were enrolled in the Baby Teeth Talk trial between February 2010 and May 2011 and were randomized in the present trial to the immediate intervention group or the delayed intervention group. Intention-to-treat principles were used for all data analyses to estimate the effect of the intervention on dental caries experience. Data analysis was performed from April 10 to May 27, 2019. Interventions The intervention comprised 4 services to participants: (1) dental care to mothers during pregnancy, (2) application of fluoride varnish to children's teeth, (3) anticipatory guidance in the form of oral health educational packages, and (4) motivational interviewing for pregnant mothers and children at ages 6, 12, and 18 months in the immediate intervention group and at ages 24, 30, and 36 months in the delayed intervention group. Main Outcomes and Measures The primary outcome was the mean number, in the primary dentition, of decayed, missing, or filled teeth (dmft) at age 5 years. Individual components of the dmft index were examined, as was the prevalence of dmft greater than 0. Results Of the 449 Aboriginal mothers and children recruited, 223 (49.7%) were randomized to the immediate intervention group and 225 (50.1%) to the delayed intervention group. The mean dmft at age 5 years was 2.10 (95% CI, 2.04 to 2.16) for children in the immediate intervention group and 2.91 (95% CI, 2.83 to 3.00) for children in the delayed intervention group (adjusted mean difference, -1.02; 95% CI, -1.81 to -0.22). When considering children in nonmetropolitan locations, the differences were stark; the mean dmft was 2.46 (95% CI, 2.38-2.54) for children in the immediate intervention group and 3.65 (95% CI, 3.53 to 3.78) for children in the delayed intervention group, with an adjusted mean difference of -1.52 (95% CI, -2.61 to -0.43). Most of this difference was accounted for by missing teeth, with the mean number of missing teeth of children in the immediate intervention group living in nonmetropolitan locations being 0.29 (95% CI, 0.27 to 0.31) compared with 1.02 (95% CI, 0.96 to 1.07) for their counterparts in the delayed intervention group. A 3-fold difference was observed in the percentage of missing teeth greater than 0 between children in the immediate intervention group and those in the delayed intervention group (10.8 [95% CI, 10.2 to 11.4] vs 31.0 [95% CI, 30.1 to 31.8]). Conclusions and Relevance This trial found that a multifaceted initiative to reduce early-childhood caries continued to be efficacious in participating indigenous children aged 5 years, especially those residing in nonmetropolitan locations and with teeth missing because of dental disease. Trial Registration anzctr.org.au Identifier: ACTRN12611000111976.",2019,"A 3-fold difference was observed in the percentage of missing teeth greater than 0 between children in the immediate intervention group and those in the delayed intervention group (10.8 [95% CI, 10.2 to 11.4] vs 31.0 [95% CI, 30.1 to 31.8]). ","['participating indigenous children aged 5 years', 'Aboriginal children in South Australia, Australia', '449 Aboriginal mothers and children recruited, 223 (49.7', 'participants of the Baby Teeth Talk Study', 'Participants included 448 mother or caregiver-child dyads who were enrolled in the Baby Teeth Talk trial between February 2010 and May 2011', 'Indigenous Children in Australia', 'Aboriginal children in Australia']","[""4 services to participants: (1) dental care to mothers during pregnancy, (2) application of fluoride varnish to children's teeth, (3) anticipatory guidance in the form of oral health educational packages, and (4) motivational interviewing"", 'early-childhood dental intervention', 'multifaceted initiative', 'delayed intervention group', 'immediate intervention group or the delayed intervention group']","['mean number, in the primary dentition, of decayed, missing, or filled teeth (dmft', 'percentage of missing teeth', 'Dental Caries']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0150134', 'cui_str': 'Anticipatory guidance'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0029162'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0399066', 'cui_str': 'Pack filling'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}]",448.0,0.131019,"A 3-fold difference was observed in the percentage of missing teeth greater than 0 between children in the immediate intervention group and those in the delayed intervention group (10.8 [95% CI, 10.2 to 11.4] vs 31.0 [95% CI, 30.1 to 31.8]). ","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jamieson', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smithers', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hedges', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mills', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Kapellas', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Diep', 'Initials': 'D', 'LastName': 'Ha', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Loc', 'Initials': 'L', 'LastName': 'Do', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Ju', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.15611'] 1019,31771648,Comparison of the anatomical and functional success of fascia and perichondrium grafts in transcanal endoscopic type 1 tympanoplasty.,"BACKGROUND There are no studies in the literature, comparing the functional and anatomical successes of the use of fascial and perichondrial grafts in endoscopic type 1 tympanoplasties. OBJECTIVES To compare the anatomical and functional outcomes of grafting with the fascia of the temporalis muscle and with the perichondrium of the tragal cartilage in patients undergoing primary transcanal type 1 tympanoplasty with endoscopy. METHODS We enrolled a total of 151 patients (80 females and 71 males with a mean age of 26.0 ± 9.3 years in the age range between 18-57) with MERI scores ranging from 1 to 3 and who underwent a transcanal endoscopic type 1 tympanoplasty without tympanomeatal flap elevation. The patients were assigned to two groups according to the type of the graft used. The patients were assigned to either the tragal cartilage perichondrium group (Group A) or the fascia of the temporal muscle (Group B). The groups were compared according to the pre- and postoperative air-bone gaps and to the status of the tympanic membrane. RESULTS There were no statistically significant differences in the distribution of the age, gender, localization, MERI scores, the duration of the operation, and the size of the perforation (all p values> 0.05). The pre-operative air-bone gap values of Group A and B did not show a statistically significant difference (p = 0.073). The postoperative improvement in the air-bone gap value did not demonstrate a significant difference between Group A and B (p = 0.202). The graft retention rates were 94.9 and 97.2% in Group A and in Group B respectively. There were no statistically significant differences between the two groups in terms of the graft retention success rates (p = 0.743). CONCLUSION Perichondrium and fascia were suitable for use in endoscopic tympanoplasties.",2019,The postoperative improvement in the air-bone gap value did not demonstrate a significant difference between Group A and B (p = 0.202).,"['transcanal endoscopic type 1 tympanoplasty', 'patients undergoing primary transcanal type 1 tympanoplasty with endoscopy', '151 patients (80 females and 71 males with a mean age of 26.0\u2009±\u20099.3\u2009years in the age range between 18-57) with MERI scores ranging from 1 to 3 and who underwent a transcanal endoscopic type 1 tympanoplasty without tympanomeatal flap elevation']","['fascia and perichondrium grafts', 'tragal cartilage perichondrium group (Group A) or the fascia of the temporal muscle']","['distribution of the age, gender, localization, MERI scores, the duration of the operation, and the size of the perforation', 'graft retention success rates', 'pre-operative air-bone gap values', 'graft retention rates']","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0225361', 'cui_str': 'Perichondrium (body structure)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0039487', 'cui_str': 'Temporal Muscle'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",151.0,0.0359134,The postoperative improvement in the air-bone gap value did not demonstrate a significant difference between Group A and B (p = 0.202).,"[{'ForeName': 'Kadir', 'Initials': 'K', 'LastName': 'Özdamar', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Private Lotus Hospital, Şanlıurfa, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Medical Faculty, Harran University, Şanlıurfa, Turkey. dralpersen@gmail.com.'}]",Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale,['10.1186/s40463-019-0386-z'] 1020,31115153,Preemptive one lung ventilation enhances lung collapse during thoracoscopic surgery: A randomized controlled trial.,"In routine practice, one lung ventilation (OLV) is initiated upon pleural opening. We conducted a randomized controlled trial to compare lung collapse after preemptive OLV versus conventional OLV in thoracoscopic surgery. A total of 67 patients were enrolled (34 with conventional OLV; 33 with preemptive OLV). Preemptive OLV was conducted by closing the DLT lumen to the non-ventilated lung immediately upon assuming the lateral position with the distal port closed to the atmosphere until pleural opening (>6 minutes in all cases). Lung collapse was assessed at 1, 5, 10, 20, 30 and 40 minutes after pleural opening using a 10-point rating scale (10: complete collapse). The primary end point was the duration from pleural opening to satisfactory lung collapse (score of 8). Secondary end points included PaO 2 and hypoxemia. The duration from pleural opening to satisfactory lung collapse was shorter in the preemptive OLV group (9.1 ± 1.2 vs. 14.1 ± 4.7 minutes, P < 0.01). PaO 2 was comparable between the two groups prior to anesthetic induction (T0), and 20 (T2), 40 minutes (T3) after pleural incision, but was lower in the preemptive OLV group at zero minutes after pleural incision (T1) (457.5 ± 19.0 vs. 483.1 ± 18.1 mmHg, P < 0.01). No patients in either group developed hypoxemia. In summary, preemptive OLV expedites lung collapse during thoracoscopic surgery with minimal safety concern.",2019,"PaO 2 was comparable between the two groups prior to anesthetic induction (T0), and 20 (T2), 40 minutes (T3) after pleural incision, but was lower in the preemptive OLV group at zero minutes after pleural incision (T1) (457.5 ± 19.0 vs. 483.1 ± 18.1 mmHg, P < 0.01).","['67 patients were enrolled (34 with conventional OLV; 33 with preemptive OLV', 'thoracoscopic surgery']","['preemptive OLV versus conventional OLV', 'Preemptive one lung ventilation', 'Preemptive OLV', 'thoracoscopic surgery']","['Lung collapse', 'hypoxemia', 'PaO 2 and hypoxemia', 'duration from pleural opening to satisfactory lung collapse', 'duration from pleural opening to satisfactory lung collapse (score of 8']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0559312', 'cui_str': 'Single-Lung Ventilation'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}]","[{'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",67.0,0.0425045,"PaO 2 was comparable between the two groups prior to anesthetic induction (T0), and 20 (T2), 40 minutes (T3) after pleural incision, but was lower in the preemptive OLV group at zero minutes after pleural incision (T1) (457.5 ± 19.0 vs. 483.1 ± 18.1 mmHg, P < 0.01).","[{'ForeName': 'Yunxiao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Wanpu', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The First Department of Thoracic Surgery, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xiaozheng', 'Initials': 'X', 'LastName': 'Kang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The First Department of Thoracic Surgery, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The First Department of Thoracic Surgery, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The First Department of Thoracic Surgery, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jiheng', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Thoracic cancer,['10.1111/1759-7714.13091'] 1021,31202641,Complementary low-density lipoprotein-cholesterol lowering and pharmacokinetics of adding bempedoic acid (ETC-1002) to high-dose atorvastatin background therapy in hypercholesterolemic patients: A randomized placebo-controlled trial.,"BACKGROUND Bempedoic acid is an oral, once-daily, first-in-class medication being developed to treat hypercholesterolemia. OBJECTIVE The aim of the study was to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy of bempedoic acid added to stable high-intensity atorvastatin background therapy and multiple-dose plasma pharmacokinetics of atorvastatin alone and combined with steady-state bempedoic acid. METHODS This was a phase 2 study in patients with hypercholesterolemia (NCT02659397). Patients received once-daily open-label atorvastatin 80 mg for 4 weeks then were randomized 2:1 at baseline to receive double-blind bempedoic acid 180 mg (n = 45) or placebo (n = 23) plus open-label atorvastatin 80 mg for 4 weeks. Efficacy was assessed 4 weeks after randomization. Atorvastatin and metabolites' steady-state levels were analyzed before first dosing with bempedoic acid and after 2 weeks of treatment. RESULTS The 4-week stabilization phase with 80 mg atorvastatin resulted in approximately 40% lowering of LDL-C values from screening. The placebo-adjusted least squares mean lowering of LDL-C from baseline to Day 29 with bempedoic acid was 22% (P = .003). Placebo-adjusted reductions from baseline with bempedoic acid also were significant for total cholesterol (-10%; P = .014), non-high-density lipoprotein cholesterol (-13%; P = .015), apolipoprotein B (-15%; P = .004), and high-sensitivity C-reactive protein (-44%; P = .002). Point estimates of bempedoic acid effects on steady-state atorvastatin and ortho-hydroxy atorvastatin area under the curve were <30% and not clinically meaningful. CONCLUSIONS Bempedoic acid 180 mg added to stable high-dose atorvastatin therapy effectively lowers LDL-C in patients with hypercholesterolemia without causing clinically important increases in atorvastatin exposure.",2019,The 4-week stabilization phase with 80 mg atorvastatin resulted in approximately 40% lowering of LDL-C values from screening.,"['hypercholesterolemic patients', 'patients with hypercholesterolemia', 'patients with hypercholesterolemia (NCT02659397']","['Bempedoic acid 180\xa0mg added to stable high-dose atorvastatin therapy', 'placebo', 'once-daily open-label atorvastatin 80\xa0mg for 4\xa0weeks then were randomized 2:1 at baseline to receive double-blind bempedoic acid 180\xa0mg (n\xa0=\xa045) or placebo (n\xa0=\xa023) plus open-label atorvastatin 80\xa0mg for 4\xa0weeks', 'atorvastatin alone and combined with steady-state bempedoic acid', 'Placebo', 'atorvastatin background therapy', 'atorvastatin']","['Efficacy', ""Atorvastatin and metabolites' steady-state levels"", 'total cholesterol', 'non-high-density lipoprotein cholesterol', 'low-density lipoprotein cholesterol (LDL-C)-lowering efficacy', 'LDL-C values', 'LDL-C', 'high-sensitivity C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]","[{'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1124482', 'cui_str': 'atorvastatin 80 MG'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.223283,The 4-week stabilization phase with 80 mg atorvastatin resulted in approximately 40% lowering of LDL-C values from screening.,"[{'ForeName': 'Narendra D', 'Initials': 'ND', 'LastName': 'Lalwani', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA. Electronic address: nlalwani@esperion.com.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Hanselman', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}, {'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'MacDougall', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}, {'ForeName': 'Lulu R', 'Initials': 'LR', 'LastName': 'Sterling', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}, {'ForeName': 'Clay T', 'Initials': 'CT', 'LastName': 'Cramer', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.05.003'] 1022,31789457,Accelerated hair growth by combining thread monofilament and minoxidil in female androgenetic alopecia.,"BACKGROUND Monofilament thread therapy (PLLA) and minoxidil have been used as alternative treatments for female androgenetic alopecia. AIM The aim was to determine the efficacy and safety of thread therapy combined with minoxidil in female androgenetic alopecia. PATIENT AND METHODS Twenty-seven women were enrolled in this randomized half-split study based on a left-head to the right-head pattern. Thread therapy (PLLA) treatment was unilaterally performed (once); minoxidil was bilaterally applied for 6 months. Global photographs and dermoscopy assessments were performed in the baseline and every 2 months till the end of treatment. Global photographs underwent blinded review by three independent dermatologists. RESULTS Mean hair density increased from 114 ± 27 to 143 ± 25/cm 2 (P < .001) in the combined group and from 113 ± 24 to 123 ± 19/cm 2 in the minoxidil group (P < .001). The mean change from baseline between the two groups was also compared (P = .003). Global photographs showed improvement in 93% (25/27) patients in the combined group and 52% (14/27) patients in the minoxidil group. CONCLUSION Poly-l-lactic acid microthread therapy combined with minoxidil may improve hair density, hair thickness, and hair appearance better than minoxidil alone.",2020,"RESULTS Mean hair density increased from 114 ± 27 to 143 ± 25/cm 2 (P < .001) in the combined group and from 113 ± 24 to 123 ± 19/cm 2 in the minoxidil group (P < .001).","['female androgenetic alopecia', 'Twenty-seven women were enrolled in this randomized half-split study based on a left-head to the right-head pattern']","['Monofilament thread therapy (PLLA) and minoxidil', 'Thread therapy (PLLA', 'minoxidil']","['efficacy and safety', 'Mean hair density', 'hair density, hair thickness, and hair appearance better']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",27.0,0.0389189,"RESULTS Mean hair density increased from 114 ± 27 to 143 ± 25/cm 2 (P < .001) in the combined group and from 113 ± 24 to 123 ± 19/cm 2 in the minoxidil group (P < .001).","[{'ForeName': 'Fathia M', 'Initials': 'FM', 'LastName': 'Khattab', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Hagar', 'Initials': 'H', 'LastName': 'Bessar', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13228'] 1023,31786121,"Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND Immunotherapy in combination with chemotherapy has shown promising efficacy across many different tumour types. We report the prespecified second interim overall survival analysis of the phase 3 IMpassion130 study assessing the efficacy and safety of atezolizumab plus nab-paclitaxel in patients with unresectable, locally advanced or metastatic triple-negative breast cancer. METHODS In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 246 academic centres and community oncology practices in 41 countries, patients aged 18 years or older, with previously untreated, histologically documented, locally advanced or metastatic triple-negative breast cancer, and Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Patients were randomly assigned (1:1) using a permuted block method (block size of four) and an interactive voice-web response system. Randomisation was stratified by previous taxane use, liver metastases, and PD-L1 expression on tumour-infiltrating immune cells. Patients received atezolizumab 840 mg or matching placebo intravenously on day 1 and day 15 of every 28-day cycle and nab-paclitaxel 100 mg/m 2 of body surface area intravenously on days 1, 8, and 15 until progression or unacceptable toxicity. Investigators, patients, and the funder were masked to treatment assignment. Coprimary endpoints were investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival, assessed in the intention-to-treat population and in patients with PD-L1 immune cell-positive tumours (tumours with ≥1% PD-L1 expression). The final progression-free survival results were previously reported at the first interim overall survival analysis. The prespecified statistical testing hierarchy meant that overall survival in the subgroup of PD-L1 immune cell-positive patients could only be formally tested if overall survival was significantly different between the treatment groups in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02425891. FINDINGS Between June 23, 2015, and May 24, 2017, 902 patients were enrolled, of whom 451 were randomly assigned to receive atezolizumab plus nab-paclitaxel and 451 were assigned to receive placebo plus nab-paclitaxel (the intention-to-treat population). Six patients from each group did not receive treatment. At the second interim analysis (data cutoff Jan 2, 2019), median follow-up was 18·5 months (IQR 9·6-22·8) in the atezolizumab group and 17·5 months (8·4-22·4) in the placebo group. Median overall survival in the intention-to-treat patients was 21·0 months (95% CI 19·0-22·6) with atezolizumab and 18·7 months (16·9-20·3) with placebo (stratified hazard ratio [HR] 0·86, 95% CI 0·72-1·02, p=0·078). In the exploratory overall survival analysis in patients with PD-L1 immune cell-positive tumours, median overall survival was 25·0 months (95% CI 19·6-30·7) with atezolizumab versus 18·0 months (13·6-20·1) with placebo (stratified HR 0·71, 0·54-0·94]). As of Sept 3, 2018 (the date up to which updated safety data were available), the most common grade 3-4 adverse events were neutropenia (38 [8%] of 453 patients in the atezolizumab group vs 36 [8%] of 437 patients in the placebo group), peripheral neuropathy (25 [6%] vs 12 [3%]), decreased neutrophil count (22 [5%] vs 16 [4%]), and fatigue (17 [4%] vs 15 [3%]). Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure). No new treatment-related deaths have been reported since the primary clinical data cutoff date (April 17, 2018). INTERPRETATION Consistent with the first interim analysis, this second interim overall survival analysis of IMpassion130 indicates no significant difference in overall survival between the treatment groups in the intention-to-treat population but suggests a clinically meaningful overall survival benefit with atezolizumab plus nab-paclitaxel in patients with PD-L1 immune cell-positive disease. However, this positive result could not be formally tested due to the prespecified statistical testing hierarchy. For patients with PD-L1 immune cell-positive metastatic triple-negative breast cancer, atezolizumab plus nab-paclitaxel is an important therapeutic option in a disease with high unmet need. FUNDING F Hoffmann-La Roche and Genentech.",2020,Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure).,"['patients with unresectable, locally advanced or metastatic triple-negative breast cancer', 'Between June 23, 2015, and May 24, 2017, 902 patients were enrolled, of whom 451', 'unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130', 'patients with PD-L1 immune cell-positive metastatic triple-negative breast cancer', 'patients with PD-L1 immune cell-positive disease', '246 academic centres and community oncology practices in 41 countries, patients aged 18 years or older, with previously untreated, histologically documented, locally advanced or metastatic triple-negative breast cancer, and Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible']","['atezolizumab plus nab-paclitaxel', 'atezolizumab', 'Atezolizumab plus nab-paclitaxel', 'placebo', 'permuted block method (block size of four) and an interactive voice-web response system', 'placebo plus nab-paclitaxel', 'atezolizumab 840 mg or matching placebo']","['peripheral neuropathy', 'investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival', 'efficacy and safety', 'septic shock', 'overall survival', 'median overall survival', 'neutropenia', 'Median overall survival', 'neutrophil count', 'deaths', 'fatigue', 'final progression-free survival results']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",902.0,0.735947,Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: p.schmid@qmul.ac.uk.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Cancer Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil; Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Grupo Oncoclínicas, Porto Alegre, Brazil.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France; Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Henschel', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Molinero', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Maiya', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Amreen', 'Initials': 'A', 'LastName': 'Husain', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Leisha A', 'Initials': 'LA', 'LastName': 'Emens', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30689-8'] 1024,31775574,The feasibility of a purpose-renewal intervention after treatment for early stage breast cancer: A brief report.,"This feasibility study evaluated the acceptability, implementability, and preliminary efficacy of a brief purpose renewal intervention (the Compass Course) using a one-group pretest-posttest design. Fifteen women who had completed treatment for early-stage breast cancer enrolled in the study. Twelve completed the eight-session group intervention that was designed to help participants identify daily priorities (actual and aspired) that most align with their personal strengths, values, and sources of meaning, that is, their inner compass. The intervention was found to be acceptable and implementable. Preliminary pre- and post-intervention outcomes suggested that participants experienced greater purpose in daily life at posttest but that they did not make demonstrable changes in their activities or roles. Results suggest that the Compass Course was feasible and further study related to purpose renewal for adults with early-stage cancer is warranted.",2020,Preliminary pre- and post-intervention outcomes suggested that participants experienced greater purpose in daily life at posttest but that they did not make demonstrable changes in their activities or roles.,"['early stage breast cancer', 'adults with early-stage cancer', 'Fifteen women who had completed treatment for early-stage breast cancer enrolled in the study']",[],['daily life'],"[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",15.0,0.0200507,Preliminary pre- and post-intervention outcomes suggested that participants experienced greater purpose in daily life at posttest but that they did not make demonstrable changes in their activities or roles.,"[{'ForeName': 'Mary Vining', 'Initials': 'MV', 'LastName': 'Radomski', 'Affiliation': 'Courage Kenny Research Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen K', 'Initials': 'KK', 'LastName': 'Swenson', 'Affiliation': 'Virginia Piper Cancer Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mattie', 'Initials': 'M', 'LastName': 'Anheluk', 'Affiliation': 'Courage Kenny Rehabilitation Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joette', 'Initials': 'J', 'LastName': 'Zola', 'Affiliation': 'Courage Kenny Rehabilitation Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kreiger', 'Affiliation': 'Courage Kenny Research Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Rabusch', 'Affiliation': 'Courage Kenny Research Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Halsten', 'Affiliation': 'Courage Kenny Rehabilitation Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Kath', 'Affiliation': 'Courage Kenny Research Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Carroll', 'Affiliation': 'Courage Kenny Research Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Zust', 'Affiliation': 'Gustavus Adolphus College, St Peter, Minnesota, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2019.1692990'] 1025,31707286,Effectiveness of vitamin D supplementation in Swedish children may be negatively impacted by BMI and serum fructose.,"In regions where sunlight exposure is limited, dietary vitamin D intake becomes important for maintaining status. However, Swedish children have been shown to have deficient or marginal status during the winter months even if the recommended dietary intake is met. Since low vitamin D status has been associated with several disease states, this study investigated the metabolic changes associated with improved vitamin D status due to supplementation. During the 3 winter months, 5-7-year-old children (n=170) in northern (Umeå, 63° N) and southern (Malmö, 55° N) Sweden were supplemented daily with 2 (placebo), 10 or 25 μg of vitamin D. BMI-for-age z-scores (BAZ), S-25(OH)D concentrations, insulin concentrations and the serum metabolome were assessed at baseline and follow-up. S-25(OH)D concentrations increased significantly in both supplementation groups (P<.001). Only arginine and isopropanol concentrations exhibited significant associations with improvements in S-25(OH)D. Furthermore, the extent to which S-25(OH)D increased was correlated with a combination of baseline BAZ and the change in serum fructose concentrations from baseline to follow up (P=.012). In particular, the change in S-25(OH)D concentrations was negatively correlated (P=.030) with the change in fructose concentrations for subjects with BAZ ≥0 and consuming at least 20 μg vitamin D daily. These results suggest that although the metabolic changes associated with improved vitamin D status are small, the effectiveness of dietary supplementation may be influenced by serum fructose concentrations.",2020,"In particular, the change in S-25(OH)D concentrations was negatively correlated (P=.030) with the change in fructose concentrations for subjects with BAZ ≥0 and consuming at least 20 μg vitamin D daily.","['N', 'Swedish children', '5-7-year-old children (n=170) in northern (Umeå, 63° N) and southern (Malmö, 55°']","['Sweden were supplemented daily with 2 (placebo', 'vitamin D supplementation']","['S-25(OH)D concentrations, insulin concentrations and the serum metabolome', 'BMI and serum fructose', 'serum fructose concentrations', 'change in S-25(OH)D concentrations', 'S-25(OH)D concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0663555,"In particular, the change in S-25(OH)D concentrations was negatively correlated (P=.030) with the change in fructose concentrations for subjects with BAZ ≥0 and consuming at least 20 μg vitamin D daily.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McClorry', 'Affiliation': 'Department of Nutrition and Technology, University of California, Davis, CA, USA. Electronic address: svmcclorry@ucdavis.edu.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Slupsky', 'Affiliation': 'Department of Nutrition and Technology, University of California, Davis, CA, USA; Department of Food Science and Technology, University of California, Davis, CA, USA. Electronic address: cslupsky@ucdavis.edu.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden,. Electronic address: torbjorn.lind@umu.se.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Karlsland Åkeson', 'Affiliation': 'Faculty of Medicine, Department of Clinical Sciences, Pediatrics, Lund University, Malmö/Lund, Sweden. Electronic address: Pia.Karlsland_Akeson@med.lu.se.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Hernell', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden,. Electronic address: olle.hernell@umu.se.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Öhlund', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden,. Electronic address: inger.ohlund@umu.se.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.108251'] 1026,31769596,A randomized study showing improved skin quality and aesthetic appearance of dorsal hands after hyaluronic acid gel treatment in a Chinese population.,"BACKGROUND Patients are increasingly aware of the aesthetic appearance of aging hands. AIMS To evaluate efficacy and safety of a hyaluronic acid gel for improving skin quality in aged skin of the dorsal hand. METHODS This was a 15-month randomized, multi-center, evaluator-blinded, split-hand, no treatment-controlled study. Three treatments with hyaluronic acid gel were administered in the same hand in adult Chinese subjects with grade 2 or 3 (mild or moderate aging) on the Hand Grading Scale (HGS). The primary objective was to evaluate the difference at 3 months between treated and untreated hands, based on the blinded evaluator's HGS assessment. Secondary assessments included the Global Aesthetic Improvement Scale (GAIS), biophysical measurements (skin elasticity, skin roughness and hydration), and subject satisfaction. Safety was evaluated by incidence of adverse events. RESULTS A total of 100 subjects were enrolled. Clinically relevant differences in HGS favored HA gel (P < .0001). At 15 months, 87%-96% of treated hands were still improved according to GAIS (per evaluator and subject, respectively). Objective measures of skin quality improved, confirmed by evaluators and highly satisfied subjects. Treatment was well tolerated. CONCLUSIONS Hyaluronic acid treatment improved skin quality and reduced the aging appearance of the hand, with high subject satisfaction.",2020,Clinically relevant differences in HGS favored HA gel (P < .0001).,"['adult Chinese subjects with grade 2 or 3 (mild or moderate aging) on the Hand Grading Scale (HGS', 'aged skin of the dorsal hand', 'a Chinese population', '100 subjects were enrolled']","['Hyaluronic acid', 'hyaluronic acid gel']","['Global Aesthetic Improvement Scale (GAIS), biophysical measurements (skin elasticity, skin roughness and hydration), and subject satisfaction', 'skin quality and aesthetic appearance of dorsal hands', 'skin quality', 'tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222045'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity (observable entity)'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}]",100.0,0.0514832,Clinically relevant differences in HGS favored HA gel (P < .0001).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Air Force General Hospital PLA, Beijing, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Fudan University Huashan Hospital, Shanghai, China.'}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Ruiyan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Air Force General Hospital PLA, Beijing, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Fudan University Huashan Hospital, Shanghai, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13221'] 1027,31823786,Social capital is associated with lower mosquito vector indices: secondary analysis from a cluster randomised controlled trial of community mobilisation for dengue prevention in Mexico.,"BACKGROUND Control of the Aedes aegypti mosquito is central to reducing the risk of dengue, zika, chikungunya, and yellow fever. Randomised controlled trials, including the Camino Verde trial in Mexico and Nicaragua, demonstrate the convincing impact of community mobilisation interventions on vector indices. These interventions might work through building social capital but little is known about the relationship between social capital and vector indices. METHODS A secondary analysis used data collected from 45 intervention clusters and 45 control clusters in the impact survey of the Mexican arm of the Camino Verde cluster randomised controlled trial. Factor analysis combined responses to questions about aspects of social capital to create a social capital index with four constructs, their weighted averages then combined into a single scale. We categorised households as having high or low social capital based on their score on this scale. We examined associations between social capital and larval and pupal vector indices, taking account of the effects of other variables in a multivariate analysis. We report associations as odds ratios and 95% confidence intervals. RESULTS The four social capital constructs were involvement, participation, investment, and communication. Among the 10,112 households, those in rural communities were much more likely to have a high social capital score (OR 4.51, 95% CIca 3.26-6.26). Households in intervention sites had higher social capital, although the association was not significant at the 5% level. Households with high social capital were more likely to be negative for larvae or pupae (OR 1.38, 95% CIca 1.12-1.69) and for pupae specifically (OR 1.37, 95% CIca 1.08-1.74). There was interaction between intervention status and social capital; in multivariate analysis, a combined variable of intervention/high social capital remained associated with larvae or pupae (ORa l.56, 95% CIca 1.19-2.04) and with pupae specifically (ORa 1.65, 95% CIca 1.20-2.28). CONCLUSION This is the first report of an association of high social capital with low vector indices. Our findings support the idea that the Camino Verde community mobilisation intervention worked partly through an interaction with social capital. Understanding such interactions may help to maximise the impact of future community mobilisation interventions.",2019,Our findings support the idea that the Camino Verde community mobilisation intervention worked partly through an interaction with social capital.,"['10,112 households, those in rural communities', 'A secondary analysis used data collected from 45 intervention clusters and 45 control clusters in the impact survey of the Mexican arm of the Camino Verde cluster randomised controlled trial']",[],"['negative for larvae or pupae', 'high social capital score', 'higher social capital']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0023047', 'cui_str': 'Larva'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0387085,Our findings support the idea that the Camino Verde community mobilisation intervention worked partly through an interaction with social capital.,"[{'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Alvarado-Castro', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Paredes-Solís', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México. srgprds@gmail.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nava-Aguilera', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México.'}, {'ForeName': 'Arcadio', 'Initials': 'A', 'LastName': 'Morales-Pérez', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Flores-Moreno', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Legorreta-Soberanis', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Jaimes-Néstor', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cockcroft', 'Affiliation': 'Department of Family Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino s/n. Colonia El Roble, CP, 39640, Acapulco, Guerrero, México.'}]",Population health metrics,['10.1186/s12963-019-0199-3'] 1028,31210361,The role of peer mindsets in students' learning: An experimental study.,"BACKGROUND Research indicates that implicit theories of intelligence, specifically growth mindset, are conducive to students' academic achievement and engagement. While much research has focused on the role of teachers and parents, it is unclear how implicit theories of intelligence operate in the peer context. AIMS This study examined the effects of peers' mindsets on students' learning outcomes. We predicted that participants surrounded by peers endorsing a growth mindset would show increased learning outcomes; in contrast, such outcomes would be dampened for individuals in a fixed mindset peer context. We also expected that perceptions of peers' competence would serve as a mechanism underlying the effects of growth mindset. SAMPLE A total of 134 undergraduate students (88 females) participated in the study. Students were of diverse ethnic background. METHODS Participants were randomly assigned to one of two experimental conditions where they interacted with trained confederates who endorsed either a growth or fixed mindset viewpoint. Confederates were trained to include specific phrases regarding the nature of ability in a conversation they had with the participants. Participants subsequently completed a problem-solving task and a survey. RESULTS Participants who interacted with peers endorsing a growth (vs. fixed) mindset viewpoint showed increased task value on the problem-solving task. Perceptions of peers' competence mediated the relationship between a growth mindset peer context and participants' task value. CONCLUSIONS Findings provide preliminary evidence that peer mindsets can influence individuals' valuing of a task. As such, peers may be an important resource to be considered when designing growth mindset interventions.",2020,"RESULTS Participants who interacted with peers endorsing a growth (vs. fixed) mindset viewpoint showed increased task value on the problem-solving task.","[""students' learning"", ""peers' mindsets on students' learning outcomes"", 'Participants subsequently completed a problem-solving task and a survey', '134 undergraduate students (88 females) participated in the study', 'Participants']",['trained confederates who endorsed either a growth or fixed mindset viewpoint'],['learning outcomes'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}]",134.0,0.0318474,"RESULTS Participants who interacted with peers endorsing a growth (vs. fixed) mindset viewpoint showed increased task value on the problem-solving task.","[{'ForeName': 'Pamela C', 'Initials': 'PC', 'LastName': 'Sheffler', 'Affiliation': 'University of California, Riverside, California, USA.'}, {'ForeName': 'Cecilia S', 'Initials': 'CS', 'LastName': 'Cheung', 'Affiliation': 'University of California, Riverside, California, USA.'}]",The British journal of educational psychology,['10.1111/bjep.12299'] 1029,31781732,Is the Effect of a High-Intensity Functional Exercise Program on Functional Balance Influenced by Applicability and Motivation among Older People with Dementia in Nursing Homes?,"BACKGROUND AND OBJECTIVES Exercise can be an important way of maintaining balance function in people with dementia, but further investigation is needed to determine the optimal way of exercising. The objective was to evaluate whether exercise applicability (i.e., attendance, exercise intensity, and adverse events) and motivation were associated with the effect on functional balance of a high-intensity functional exercise program for older people with dementia in nursing homes. DESIGN, SETTING AND PARTICIPANTS Exercise intervention participants (n = 81; 60 women, 21 men) from a randomized controlled trial (UMDEX) were included. Their mean age was 84 and mean Mini-Mental State Examination score was 15. INTERVENTION Groups of 3-8 participants participated in the High-Intensity Functional Exercise (HIFE) Program, with 5 sessions per 2-week period, for 4 months (total, 40 sessions). MEASUREMENTS Outcome was the Berg Balance Scale (BBS), assessed at baseline and follow up, and the score difference, dichotomized to classify participants into two groups: responders (≥5-point increase) and non-responders (<5-point increase). Target variables were measures of applicability and motivation. Associations between each target variable and the outcome were analyzed using multivariable logistic regression. Baseline characteristics and new medical conditions developing during the intervention period were compared between responders and non-responders and included in the analyses when p < 0.10. RESULTS The BBS score was 28.6 ± 14.3 at baseline and 31.2 ± 15.3 at follow up, with the difference between follow-up and baseline scores ranging from -35 to 24. Twenty-nine (35.8%) participants were responders. The multivariable models showed no significant association between responders vs. non-responders and any target variable. CONCLUSION Participation in a 4-month high-intensity functional exercise program can improve balance in many individuals with dementia in nursing homes, despite the progressiveness of dementia disorders and several co-existing medical conditions. Predicting balance exercise response based on applicability and motivation seem not to be possible, which lends no support for excluding this group from functional exercise, even when exercise intensity or motivation is not high.",2019,"The BBS score was 28.6 ± 14.3 at baseline and 31.2 ± 15.3 at follow up, with the difference between follow-up and baseline scores ranging from -35 to 24.","['older people with dementia in nursing homes', 'people with dementia', 'Exercise intervention participants (n = 81; 60 women, 21 men', 'Older People with Dementia in Nursing Homes']","['High-Intensity Functional Exercise (HIFE', 'High-Intensity Functional Exercise Program', 'high-intensity functional exercise program', 'intensity functional exercise program']","['Berg Balance Scale (BBS', 'BBS score', 'mean Mini-Mental State Examination score', 'exercise applicability (i.e., attendance, exercise intensity, and adverse events) and motivation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",60.0,0.0709431,"The BBS score was 28.6 ± 14.3 at baseline and 31.2 ± 15.3 at follow up, with the difference between follow-up and baseline scores ranging from -35 to 24.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sondell', 'Affiliation': 'Anna Sondell, Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, SE-90187 Umeå, Sweden, Phone: +46907865289, Fax: +469058093, Email: anna.sondell@umu.se.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Littbrand', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Holmberg', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lindelöf', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1269-8'] 1030,31468247,Role of Organizational Support on Implementation of an Environmental Change Intervention to Improve Child Fruit and Vegetable Intake: a Randomized Cross-Over Design.,"Little is known about the role of organizational or administrative support in implementation of health promotion interventions, particularly outside of school settings. The purpose was to determine the change in fruit and vegetable (FV) intake among children living in residential children's homes (RCHs) and assess the relationships among change in organizational support, intervention implementation, and child nutrition outcomes. Data were collected from 29 RCHs and 614 children living in RCHs, as part of a group randomized design with delayed intervention, at three cross-sectional waves: 2004, 2006, and 2008. RCH staff made environmental changes to increase intake of FV. Implementation and organizational support data were collected from staff at the RCHs. Child FV intake were measured via 24-h dietary recalls. A two-way (condition by time) repeated measures ANOVA was conducted to test whether FV intake increased in response to the intervention. A two-level path analysis with a robust maximum likelihood estimator was used to explore the relationships among organizational support, intervention implementation fidelity, and child FV intake. There was a significant increase in FV intake within all RCHs from 2004 to 2006 (P = 0.022 for the intervention group, P = 0.015 for the control group). This increase was maintained in both groups from 2006 to 2008 (post-intervention mean servings: intervention = 3.2 vs control = 3.4). Increases in organizational support resulted in greater overall implementation fidelity. When RCH staff, supervisors, and the RCH CEO were perceived to be supportive of the intervention, more environmental changes were made to encourage eating FV. Fostering organizational support may improve implementation of interventions.",2019,"There was a significant increase in FV intake within all RCHs from 2004 to 2006 (P = 0.022 for the intervention group, P = 0.015 for the control group).","[""children living in residential children's homes (RCHs"", '614 children living in RCHs']",[],"['change in fruit and vegetable (FV) intake', 'FV intake', 'Child FV intake', 'overall implementation fidelity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442513', 'cui_str': ""Children's home (environment)""}]",[],"[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",614.0,0.0405036,"There was a significant increase in FV intake within all RCHs from 2004 to 2006 (P = 0.022 for the intervention group, P = 0.015 for the control group).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Gay', 'Affiliation': 'Department of Health Promotion & Behavior, University of Georgia, Athens, GA, USA. jlgay@uga.edu.'}, {'ForeName': 'Ruth P', 'Initials': 'RP', 'LastName': 'Saunders', 'Affiliation': 'Department of Health Promotion, Education and Behavior, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rees-Punia', 'Affiliation': 'American Cancer Society, Atlanta, GA, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Dowda', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'van den Berg', 'Affiliation': 'Division of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin, TX, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01043-z'] 1031,31771924,Does Initiating Vaginal Sexual Intercourse During a Safer Sex Media Campaign Influence Life Satisfaction Among African American Adolescents?,"PURPOSE Addressing adolescent sexual risk behaviors in the STI/HIV prevention literature is well documented; however, intervention impacts on life satisfaction are relatively unexplored. This study is a secondary analysis of data (N = 1,658) from a randomized, multisite, multilevel safer sex media campaign (Project iMPPACS) analyzing life satisfaction across baseline and follow-up data collected from 2006 to 2008 among participants (mean age 15.08 years) who reported never having had vaginal sex at baseline (n = 787). METHODS Participants were separated into groups based on whether they reported having vaginal sex (yes/no) at baseline. Then taking into account the nested study design and controlling for confounders, a mixed model repeated measures analysis of variance assessed whether differences in mean total life satisfaction (LS) were associated across time in the media and nonmedia study conditions separately by gender. RESULTS A significant interaction between time and media condition was detected (p = .039) where mean total LS increased +.065 units from baseline (M = 5.364) to last contact in media cities and decreased -.084 units from baseline (M = 5.557) to last contact in nonmedia cities when controlling for the effect of initiating vaginal sex. No significant differences in LS at baseline were observed between media and nonmedia intervention cities. Results by gender suggest most positive change in LS was observed for females with mixed findings for males. CONCLUSIONS Although Project iMPPACS was not designed with the intent on improving participants' life satisfaction, results advance the LS literature by demonstrating a temporal sequence for sexual risk taking and LS over time.",2020,A significant interaction between time and media condition was detected (p = .039),"['females with mixed findings for males', 'Participants were separated into groups based on whether they reported having vaginal sex (yes/no) at baseline', 'African American Adolescents', 'data (N\xa0= 1,658) from a randomized, multisite, multilevel safer sex media campaign (Project iMPPACS) analyzing life satisfaction across baseline and follow-up data collected from 2006 to 2008 among participants (mean age 15.08\xa0years) who reported never having had vaginal sex at baseline (n\xa0= 787']",[],"['mean total LS', 'time and media condition', 'mean total life satisfaction (LS', 'LS']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0713719,A significant interaction between time and media condition was detected (p = .039),"[{'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Zullig', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Public Health, West Virginia University, Morgantown, West Virginia. Electronic address: kzullig@hsc.wvu.edu.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Valois', 'Affiliation': 'Department of Health Promotion, Education & Behavior, Arnold School of Public Health, Columbia, South Carolina.'}, {'ForeName': 'Gerald R', 'Initials': 'GR', 'LastName': 'Hobbs', 'Affiliation': 'Department of Statistics, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Romer', 'Affiliation': 'Adolescent Communication Institute, Public Policy Center, Annenberg School for Communication, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'The Centers for Behavioral & Preventive Medicine, The Miriam Hospital and Brown University, Providence, Rhode Island.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'DiClemente', 'Affiliation': 'Department of Social & Behavioral Sciences, College of Global Public Health, New York University, New York, New York.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Vanable', 'Affiliation': 'Department of Psychology, Center for Health & Behavior, Syracuse University, Syracuse, New York.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.09.001'] 1032,29974545,Efficacy of Cyberbullying Prevention on Somatic Symptoms-Randomized Controlled Trial Applying a Reasoned Action Approach.,"The theory of reasoned action (ToRA) has been proposed as a framework for cyberbullying prevention design, targeting attitudes and norms. In this study effects of a long (10 weekly sessions) and a short (one day, four sessions) cyberbullying prevention program based on the ToRA were compared with a control group over 9 months. Longitudinal data from 722 students (mean age = 13.36) on cyberbullying, somatic symptoms, attitudes, and norms were analyzed within a structural equation model. Participation in the long intervention group significantly reduced cyberbullying (d = -0.584) and somatic symptoms (d = -0.316). No between-group differences emerged for attitudes and norms. Developmental trajectories and associations were found to be as suggested by ToRA in both cross-sectional and change-score analyses.",2019,Participation in the long intervention group significantly reduced cyberbullying (d = -0.584) and somatic symptoms (d = -0.316).,"['722 students (mean age\xa0=\xa013.36) on cyberbullying, somatic symptoms, attitudes, and norms were analyzed within a structural equation\xa0model']","['Cyberbullying Prevention', 'reasoned action (ToRA']",['somatic symptoms'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}]","[{'cui': 'C3178746', 'cui_str': 'Cyberbullying'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}]",722.0,0.0184843,Participation in the long intervention group significantly reduced cyberbullying (d = -0.584) and somatic symptoms (d = -0.316).,"[{'ForeName': 'Pavle', 'Initials': 'P', 'LastName': 'Zagorscak', 'Affiliation': 'Freie Universität Berlin.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Schultze-Krumbholz', 'Affiliation': 'Technische Universität Berlin.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Heinrich', 'Affiliation': 'Freie Universität Berlin.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wölfer', 'Affiliation': 'University of Oxford.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Scheithauer', 'Affiliation': 'Freie Universität Berlin.'}]",Journal of research on adolescence : the official journal of the Society for Research on Adolescence,['10.1111/jora.12429'] 1033,31911074,"Assessing the effects of 6 weeks of intermittent aerobic exercise on aerobic capacity, muscle fatigability, and quality of life in diabetic burned patients: Randomized control study.","BACKGROUND Both burn and diabetes mellitus (DM) cause functional and psychosocial disabilities. A low-cost and safe approach is greatly required to reduce these disabilities and the effects of aerobic exercise have generated varied evidence to date. The aim of the study was to explore the effects of 6 weeks of intermittent aerobic exercise (IAE) on aerobic capacity, muscle fatigability, and quality of life (QoL) in diabetic burned patients (DBPs). METHODS The study design was a prospective, single-blind, randomized controlled trial. Between March 2018 and July 2019 thirty-six (22 males and 16 females) diabetic burned patients were included in the study, their age ranged 35-55 years. They were clinically diagnosed with type 2 DM and total body surface area (TBSA) was 15-30%. The participants were randomly assigned to the IAE group (n = 18) and controls (n = 18). Aerobic capacity, muscle fatigability, and QoL were assessed initially and repeated after 6 weeks of intervention. RESULTS Initial data demonstrated non-significant differences between the IAE and control groups (p > 0.05). Comparing pre- and post-intervention outcomes showed significant improvement of VO 2 max, muscle fatigability, QoL domains in the IAE group after 6 weeks intervention (p < 0.05) and non-significant changes in the control group (p > 0.05). The IAE group showed statistically significant improvement more than the control group in all outcome measures (p < 0.05). CONCLUSIONS 6 weeks of intermittent aerobic exercise is an effective alternative modality to improve aerobic capacity, muscle fatigability, and QoL in DBPs. Adherence to intermittent aerobic exercise should be practicable into mainstream clinical intervention for those patients.",2020,"Comparing pre- and post-intervention outcomes showed significant improvement of VO 2 max, muscle fatigability, QoL domains in the IAE group after 6 weeks intervention (p < 0.05) and non-significant changes in the control group (p > 0.05).","['diabetic burned patients (DBPs', 'diabetic burned patients', 'Between March 2018 and July 2019 thirty-six (22 males and 16 females) diabetic burned patients were included in the study, their age ranged 35-55 years']","['IAE', 'intermittent aerobic exercise', 'intermittent aerobic exercise (IAE']","['VO 2 max, muscle fatigability, QoL domains', 'aerobic capacity, muscle fatigability, and QoL in DBPs', 'aerobic capacity, muscle fatigability, and quality of life', 'total body surface area (TBSA', 'Aerobic capacity, muscle fatigability, and QoL', 'aerobic capacity, muscle fatigability, and quality of life (QoL']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0058453', 'cui_str': 'discoidin-binding polysaccharide'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0231230', 'cui_str': 'Fatigability (finding)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0058453', 'cui_str': 'discoidin-binding polysaccharide'}, {'cui': 'C0034380'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.0474954,"Comparing pre- and post-intervention outcomes showed significant improvement of VO 2 max, muscle fatigability, QoL domains in the IAE group after 6 weeks intervention (p < 0.05) and non-significant changes in the control group (p > 0.05).","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt. Electronic address: walidkamal.wr@gmail.com.'}, {'ForeName': 'Nermeen Mohamed', 'Initials': 'NM', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Egypt.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.12.013'] 1034,31704535,Postural balance in pediatric posterior fossa tumor survivors: Through impairments to rehabilitation possibilities.,"BACKGROUND The rehabilitation after pediatric brain tumors is a pressing issue in current neuro-oncology. The purpose of this study was to reveal the peculiarities of postural stability in pediatric posterior fossa tumor survivors as compared to the healthy controls. Additionally, we aimed to determine the feasibility of the balance biofeedback training for these patients. METHODS We measured 6 postural stability parameters with the eyes opened and closed in 35 patients and 25 healthy controls aged 7-17. Further, the patients were divided into two groups: the intervention and waitlist. The intervention group was the first to undergo a 2-week biofeedback training designed to enhance balance control, while the waitlist group performed only the usual exercises. Then the groups were interchanged. Pre- and post-stability scores were measured in each condition. FINDINGS The current results suggest the pronounced deficiency of stability in the patients. Their results in both opened and closed eyes conditions were similar. The post-training measurements revealed that some stability parameters were improved: ellipse square and mean root square oscillations in the frontal and sagittal planes. INTERPRETATION The patients predictably demonstrated the significantly worse stability measurements as compared to the healthy controls. Moreover, they were shown not to use visual information to correct postural balance thus prompting us to assume severe deficits of the eye movements control due to the cerebellar pathology. This specificity, as well as the post-training significant improvement, emphasizes the clinical necessity to consider them when designing the rehabilitation protocols for posterior fossa tumor survivors.",2020,"The post-training measurements revealed that some stability parameters were improved: ellipse square and mean root square oscillations in the frontal and sagittal planes. ","['pediatric posterior fossa tumor survivors', '35 patients and 25 healthy controls aged 7-17']","['balance biofeedback training', 'biofeedback training designed to enhance balance control, while the waitlist group performed only the usual exercises']","['Pre- and post-stability scores', 'ellipse square and mean root square oscillations', 'stability measurements', 'Postural balance']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021432', 'cui_str': 'Posterior Fossa Tumors'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}]",,0.0137478,"The post-training measurements revealed that some stability parameters were improved: ellipse square and mean root square oscillations in the frontal and sagittal planes. ","[{'ForeName': 'Anna A', 'Initials': 'AA', 'LastName': 'Dreneva', 'Affiliation': 'Faculty of Psychology, Lomonosov Moscow State University, Mokhovaya st. 11/9, 125009 Moscow, Russia. Electronic address: annadreneva@msupsy.ru.'}, {'ForeName': 'Dmitry V', 'Initials': 'DV', 'LastName': 'Skvortsov', 'Affiliation': 'Clinical Rehabilitation Research Center, Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Samory Mashela str. 1, 117997 Moscow, Russia.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.10.025'] 1035,31867715,Carbetocin at elective caesarean section: a sequential allocation trial to determine the minimum effective dose in obese women.,"Postpartum haemorrhage is a leading cause of maternal death during childbirth. There is an increasing incidence of atonic postpartum haemorrhage in developed countries, and maternal obesity has been proposed as a contributing factor. The dose-response relationship of carbetocin in obese women has not yet been determined. We conducted a double-blind, dose-finding study of carbetocin using a biased coin up-and-down design in women with a body mass index ≥ 40 kg.m -2 undergoing elective caesarean section. The determinant for a successful response was satisfactory uterine tone, with no intra-operative need for additional uterotonic drugs. Secondary outcomes included the use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration. Thirty women were recruited to the study. The median (IQR [range]) body mass index was 44.93 (41.5-55.2 [40-66.5]) kg.m -2 . The ED 90 of carbetocin was estimated as 62.9 (95%CI 57.0-68.7) μg using the truncated Dixon and Mood method, and 68 (95%CI 52-77) μg using the isotonic regression method. The estimated blood loss was 880 (621-1178 [75-2442]) ml. The overall rates of hypotension and hypertension after delivery were 40% and 6.7%, respectively, while nausea occurred in 26.7% of women. The ED 90 for carbetocin in obese women at elective caesarean section is lower than the dose of 100 μg currently recommended by the Society of Obstetricians and Gynaecologists of Canada, but is approximately four times higher than the previously demonstrated ED 90 of 14.8 μg in women with body mass index < 40 kg.m -2 .",2020,"Secondary outcomes included the use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration.","['obese women at elective caesarean section', '40', 'kg.m -2 undergoing elective caesarean section', 'women with a body mass index ≥', 'Carbetocin at elective caesarean section', 'obese women', 'Thirty women were recruited to the study']",['carbetocin'],"['estimated blood loss', 'nausea', 'use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration', 'overall rates of hypotension and hypertension after delivery', 'median (IQR [range]) body mass index']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0054670', 'cui_str': 'oxytocin, 1-desamino-1-monocarba-(tyrosine(O-methyl))(2)-'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0054670', 'cui_str': 'oxytocin, 1-desamino-1-monocarba-(tyrosine(O-methyl))(2)-'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0054670', 'cui_str': 'oxytocin, 1-desamino-1-monocarba-(tyrosine(O-methyl))(2)-'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",30.0,0.442657,"Secondary outcomes included the use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Drew', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balki', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Farine', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Downey', 'Affiliation': ''}, {'ForeName': 'J C A', 'Initials': 'JCA', 'LastName': 'Carvalho', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, ON, Canada.'}]",Anaesthesia,['10.1111/anae.14944'] 1036,31204284,"Telemonitoring-supported exercise training, metabolic syndrome severity, and work ability in company employees: a randomised controlled trial.","BACKGROUND Metabolic syndrome is a predisposing factor for cardiovascular and metabolic disease, but also has socioeconomic relevance by affecting the health and productivity of workers. We tested the effect of regular telemonitoring-supported physical activity on metabolic syndrome severity and work ability in company employees. METHODS This was a prospective, randomised, parallel-group, and assessor-blind study done in workers in the main Volkswagen factory (Wolfsburg, Germany). Volunteers with diagnosed metabolic syndrome according to American Heart Association/National Heart, Lung, and Blood Institute criteria were randomly assigned (1:1) to a 6-month lifestyle intervention focusing on regular exercise (exercise group), or to a waiting-list control group, using a computer-based assignment list with variable block length. Participants in the exercise group received individual recommendations for exercise at face-to-face meetings and via a smartphone application, with the aim of doing 150 min physical activity per week. Activities were supervised and adapted using activity-monitor data, which were transferred to a central database. Participants in the control group continued their current lifestyle and were informed about the possibility to receive the supervised intervention after study completion. The primary outcome was the change in metabolic syndrome severity (metabolic syndrome Z score) after 6 months in the intention-to treat population. This trial is registered with ClinicalTrials.gov, number NCT03293264, and is closed to new participants. FINDINGS 543 individuals were screened between Oct 10, 2017, and Feb 27, 2018, of whom 314 (mean age 48 years [SD 8]) were randomly assigned to receive the intervention (n=160; exercise group) or to a waiting list (n=154; control group). The mean metabolic syndrome Z score for the exercise group was significantly reduced after the 6-month intervention period (0·93 [SD 0·63] before and 0·63 [0·64] after the intervention) compared with the control group (0·95 [0·55] and 0·90 [0·61]; difference between groups -0·26 [95% CI -0·35 to -0·16], p<0·0001). We documented 11 adverse events in the exercise group, with only one event (a twisted ankle) regarded as directly caused by the intervention. INTERPRETATION A 6-month exercise-focused intervention using telemonitoring systems reduced metabolic syndrome severity. This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease. FUNDING Audi BKK health insurance and the German Research Foundation through the Cluster of Excellence REBIRTH.",2019,"This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease. ","['543 individuals were screened between Oct 10, 2017, and Feb 27, 2018, of whom 314 (mean age 48 years [SD 8', 'Volunteers with diagnosed metabolic syndrome according to American Heart Association/National Heart, Lung, and Blood Institute criteria', 'company employees', 'workers in the main Volkswagen factory (Wolfsburg, Germany']","['intervention (n=160; exercise group) or to a waiting list', 'lifestyle intervention focusing on regular exercise (exercise group), or to a waiting-list control group, using a computer-based assignment list with variable block length', 'regular telemonitoring-supported physical activity', 'Telemonitoring-supported exercise training', 'individual recommendations for exercise at face-to-face meetings and via a smartphone application']","['change in metabolic syndrome severity (metabolic syndrome Z score', 'mean metabolic syndrome Z score', 'metabolic syndrome severity', 'mental health, work ability, and productivity-related outcomes']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C1955970', 'cui_str': 'National Heart, Lung, and Blood Institute'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0442614', 'cui_str': 'Factory (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",543.0,0.10718,"This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease. ","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany. Electronic address: haufe.sven@mh-hannover.de.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Kerling', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Protte', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Bayerle', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rolff', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Thorben', 'Initials': 'T', 'LastName': 'Sundermeier', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kück', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Ensslen', 'Affiliation': 'Volkswagen AG, Wolfsburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nachbar', 'Affiliation': 'Volkswagen AG, Wolfsburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lauenstein', 'Affiliation': 'Audi BKK Health Insurance, Ingolstadt, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Böthig', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Terkamp', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': 'Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hilfiker-Kleiner', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}]",The Lancet. Public health,['10.1016/S2468-2667(19)30075-1'] 1037,31786983,Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study).,"Mineralocorticoid receptors (MRs) are implicated in the pathology of hypertension. MR blockers are recommended for the treatment of salt-sensitive or resistant hypertension. However, use of currently available MR blockers is limited by adverse events. This phase 3 multicenter, randomized, double-blind study compared the efficacy and safety of esaxerenone, a new selective nonsteroidal MR blocker, at 2.5 and 5 mg/day and eplerenone 50 mg/day in Japanese patients with essential hypertension. After a 4-week washout period, 1001 eligible adults with hypertension were randomized evenly to esaxerenone 2.5 or 5 mg/day or eplerenone 50 mg/day treatments, taken orally once daily for 12 weeks. Primary end points were changes in sitting systolic or diastolic blood pressure (BP) from baseline at the end of treatment. Esaxerenone 2.5 mg/day was noninferior to eplerenone for reductions in sitting and 24-hour BP. Reductions in BP with esaxerenone 5 mg/day were significantly greater than those with esaxerenone 2.5 mg/day. Changes in diurnal BP showed persistent 24-hour antihypertensive effects in all treatment groups. The proportions of patients achieving target sitting BP (<140/90 mm Hg) were 31.5%, 41.2%, and 27.5% with esaxerenone 2.5 and 5 mg/day and eplerenone 50 mg/day, respectively. Incidences of adverse events (all mild or moderate) were similar across treatment groups. These results indicate that esaxerenone is an effective and well-tolerated MR blocker in Japanese patients with essential hypertension, with BP-lowering activity at least equivalent to eplerenone. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT02890173.",2020,Reductions in BP with esaxerenone 5 mg/day were significantly greater than those with esaxerenone 2.5 mg/day.,"['Patients With Essential Hypertension (ESAX-HTN Study', '1001 eligible adults with hypertension', 'Japanese patients with essential hypertension']","['Esaxerenone', 'esaxerenone', 'Mineralocorticoid receptors (MRs', 'eplerenone', 'esaxerenone 2.5 or 5 mg/day or eplerenone', 'MR blockers', 'Esaxerenone (CS-3150) and Eplerenone']","['24-hour antihypertensive effects', 'sitting systolic or diastolic blood pressure (BP', 'sitting and 24-hour BP', 'efficacy and safety', 'proportions of patients achieving target sitting BP', 'Incidences of adverse events', 'Reductions in BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C3541395', 'cui_str': 'Mineralocorticoids'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4278755', 'cui_str': 'CS-3150'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",1001.0,0.0655234,Reductions in BP with esaxerenone 5 mg/day were significantly greater than those with esaxerenone 2.5 mg/day.,"[{'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'From the Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan (S.I.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Endocrinology, Metabolism and Nephrology, Keio University, School of Medicine, Tokyo, Japan (H.I.).'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Japan (H.R.).'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan (Y.O., M.Y., S.Y.).'}, {'ForeName': 'Motonobu', 'Initials': 'M', 'LastName': 'Yoshimura', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan (Y.O., M.Y., S.Y.).'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamakawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan (Y.O., M.Y., S.Y.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13569'] 1038,31585796,Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial.,"BACKGROUND Tracheal intubation is common in the care of critically ill adults and is frequently complicated by hypotension, cardiac arrest, or death. We aimed to evaluate administration of an intravenous fluid bolus to prevent cardiovascular collapse during intubation of critically ill adults. METHODS We did a pragmatic, multicentre, unblinded, randomised trial in nine sites (eight ICUs and one emergency department) around the USA. Critically ill adults (≥18 years) undergoing tracheal intubation were randomly assigned (1:1, block sizes of 2, 4, and 6, stratified by study site) to either an intravenous infusion of 500 mL of crystalloid solution or no fluid bolus. The primary outcome, assessed in the intention-to-treat population, was cardiovascular collapse, defined as a new systolic blood pressure <65 mm Hg; new or increased vasopressor receipt between induction and 2 min after tracheal intubation; or cardiac arrest or death within 1 h of tracheal intubation. Adverse events were assessed in the as-treated population. This trial, which is now complete, is registered with ClinicalTrials.gov, number NCT03026777. FINDINGS Patients were enrolled from Feb 6, 2017, to Jan 9, 2018, when the data and safety monitoring board stopped the trial on the basis of futility. By trial termination, 337 (63%) of 537 screened adults had been randomly assigned. Cardiovascular collapse occurred in 33 (20%) of 168 patients in the fluid bolus group compared with 31 (18%) of 169 patients in the no fluid bolus group (absolute difference 1·3% [95% CI -7·1% to 9·7%]; p=0·76). The individual components of the cardiovascular collapse composite outcome did not differ between groups (new systolic blood pressure <65 mm Hg 11 [7%] in the bolus group vs ten [6%] in the no-bolus group, new or increased vasopressor 32 [19%] vs 31 [18%], cardiac arrest within 1 h seven [4%] vs two [1%], death within 1 h of intubation two [1%] vs one [1%]). In-hospital mortality was not significantly different in the fluid bolus group (48 [29%]) compared with no fluid bolus (59 [35%]). INTERPRETATION Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial. FUNDING US National Institutes of Health.",2019,"INTERPRETATION Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial. ","['Critically ill adults (≥18 years) undergoing tracheal intubation', 'critically ill adults undergoing tracheal intubation (PrePARE', 'critically ill adults', 'Patients were enrolled from Feb 6, 2017, to Jan 9, 2018, when the data and safety monitoring board stopped the trial on the basis of futility', 'nine sites (eight ICUs and one emergency department) around the USA', '337 (63%) of 537 screened adults had been randomly assigned']","['fluid bolus', 'intravenous fluid bolus', 'intravenous infusion of 500 mL of crystalloid solution or no fluid bolus']","['intention-to-treat population, was cardiovascular collapse, defined as a new systolic blood pressure <65 mm Hg; new or increased vasopressor receipt', 'cardiac arrest', 'cardiac arrest or death within 1 h of tracheal intubation', 'cardiovascular collapse', 'Cardiovascular collapse', 'death', 'hospital mortality', 'Adverse events', 'overall incidence of cardiovascular collapse', 'systolic blood pressure']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949757', 'cui_str': 'Data and Safety Monitoring Boards'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036974', 'cui_str': 'Circulatory Collapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",168.0,0.742292,"INTERPRETATION Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial. ","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care Medicine, and Allergy and Immunology, Louisiana State University School of Medicine New Orleans, New Orleans, LA, USA. Electronic address: djanz@lsuhsc.edu.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dargin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, MA, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Section of Emergency Medicine, Louisiana State University School of Medicine New Orleans, New Orleans, LA, USA; Department of Pulmonary and Critical Care Medicine, Ochsner Health System New Orleans, New Orleans, LA USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Dischert', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'West', 'Affiliation': 'Department of Emergency Medicine, Lincoln Medical Center, The Bronx, New York, NY, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, MA, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, MA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Caputo', 'Affiliation': 'Department of Emergency Medicine, Lincoln Medical Center, The Bronx, New York, NY, USA.'}, {'ForeName': 'Brent E', 'Initials': 'BE', 'LastName': 'Heideman', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Aline N', 'Initials': 'AN', 'LastName': 'Zouk', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Stigler', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30246-2'] 1039,31773199,Bowel preparation prior to minimally invasive sacrocolpopexy: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS The objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function. METHODS In this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon's perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher's exact test, the Wilcoxon test and the Chi-squared test. RESULTS Of 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as ""more difficult than average"" (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation. CONCLUSIONS Although there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon's perception of case complexity.",2020,"The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08,","['105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation', 'women undergoing MIS']","['minimally invasive sacrocolpopexy (MIS', 'Bowel preparation prior to minimally invasive sacrocolpopexy', 'pre-operative bowel preparation or no bowel preparation']","['report strain', ""surgeon's perception of case difficulty"", 'Baseline characteristics and rates of complications', 'ITT', 'post-operative abdominal PAC-SYM subscale', 'Constipation Symptoms (PAC-SYM', 'post-operative constipation']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",105.0,0.298916,"The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08,","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA, 15218, USA. sassanijc@upmc.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kantartzis', 'Affiliation': 'Banner University Medical Center, University of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fabio', 'Affiliation': 'Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA, 15218, USA.'}]",International urogynecology journal,['10.1007/s00192-019-04120-7'] 1040,31733813,"Task-sharing of psychological treatment for antenatal depression in Khayelitsha, South Africa: Effects on antenatal and postnatal outcomes in an individual randomised controlled trial.","The study's objective was to determine the effectiveness of a task-sharing psychological treatment for perinatal depression using non-specialist community health workers. A double-blind individual randomised controlled trial was conducted in two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town. Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS) were randomised into the intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls). The primary outcome was response on the Hamilton Depression Rating Scale (HDRS) at three months postpartum (minimum 40% score reduction from baseline) among participants who did not experience pregnancy or infant loss (modified intention-to-treat population) (registered on Clinical Trials: NCT01977326). Of 2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n = 200; intervention: n = 184). There were no significant differences in response on the HDRS at three months postpartum between the intervention and control arm. A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa. The findings give cause for reflection on the strategy of task-sharing in low-resource settings.",2020,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","['two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town', 'antenatal depression in Khayelitsha, South Africa', 'perinatal depression using non-specialist community health workers', 'Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS', '2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n\u202f=\u202f200; intervention: n\u202f=\u202f184', 'women living in Khayelitsha, South Africa']","['Task-sharing of psychological treatment', 'intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls', 'task-sharing psychological treatment']","['HDRS', 'Hamilton Depression Rating Scale (HDRS']","[{'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0222045'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",2187.0,0.206439,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","[{'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa; King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: crick.lund@uct.ac.za.""}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Garman', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Davies', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Memory', 'Initials': 'M', 'LastName': 'Munodawafa', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Honikman', 'Affiliation': 'Perinatal Mental Health Project, Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Medical Research Council, Durban, South Africa; Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bass', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bolton', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joska', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Kagee', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prince', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa; MRC Unit on Risk & Resilience in Mental Disorders, Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Hanani', 'Initials': 'H', 'LastName': 'Tabana', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa, And School of Nursing and Midwifery, Queens University, Belfast, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK; Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.""}, {'ForeName': 'Atalay', 'Initials': 'A', 'LastName': 'Alem', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Susser', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, USA; New York State Psychiatric Institute, New York, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103466'] 1041,31378648,Increasing Intake of an Unfamiliar Vegetable in Preschool Children Through Learning Using Storybooks and Sensory Play: A Cluster Randomized Trial.,"BACKGROUND Most children eat fewer vegetables than recommended. Storybooks and sensory play may increase vegetable intake. OBJECTIVE This study tested the effects on intake of learning about an unfamiliar vegetable (celeriac) through storybooks and sensory play. It was predicted that an illustrated, congruent storybook would increase intake of celeriac compared to an incongruent storybook (carrot); and that adding congruent sensory play with celeriac to the storybook would produce a synergistic effect on intake of celeriac. DESIGN Children from 12 UK preschools were randomly assigned by clusters to four intervention conditions using a 2×2 factorial design. The factors were vegetable congruency (sensory play and/or storybook were congruent, or incongruent [carrot] with celeriac) and intervention type (storybook only or storybook combined with sensory play). PARTICIPANTS/SETTING Three hundred and thirty-seven children aged 2 to 5 years were recruited to take part in November 2017. INTERVENTION Over a 2-week period, children in all four conditions were read a vegetable storybook featuring celeriac or carrot. In addition, two conditions received sensory play with either carrot or celeriac added to the storybook method. MAIN OUTCOME MEASURES Intake of the unfamiliar vegetable (celeriac) was measured at baseline and after the 2-week intervention. STATISTICAL ANALYSIS PERFORMED Complex samples logistic regression and general linear modeling were performed to examine group differences at post-intervention. RESULTS Children receiving the congruent (celeriac) storybook had higher odds of eating celeriac compared to children who received the incongruent (carrot) storybook. Receiving congruent sensory play increased the odds of eating celeriac, whereas receiving incongruent sensory play did not. From the 267 children who completed both baseline and post-intervention assessments, 85 ate no celeriac at baseline and were classed as non-eaters. Sensory play (congruent or incongruent) increased the odds of eating some celeriac in non-eaters compared to storybook only conditions. CONCLUSIONS Congruency between storybook and vegetable increased intake; sensory play with celeriac increased the likelihood of eating celeriac. Storybooks and sensory play are simple interventions to increase willingness to try an unfamiliar vegetable.",2019,"Sensory play (congruent or incongruent) increased the odds of eating some celeriac in non-eaters compared to storybook only conditions. ","['Children from 12 UK preschools', '267 children who completed both baseline and post-intervention assessments, 85 ate no celeriac at baseline and were classed as non-eaters', 'Three hundred and thirty-seven children aged 2 to 5 years were recruited to take part in November\xa02017', 'Preschool Children Through Learning']","['sensory play with either carrot or celeriac added to the storybook method', 'vegetable congruency (sensory play and/or storybook were congruent, or incongruent [carrot] with celeriac) and intervention type (storybook only or storybook combined with sensory play', 'learning about an unfamiliar vegetable (celeriac) through storybooks and sensory play']","['odds of eating celeriac', 'Intake of the unfamiliar vegetable (celeriac', 'likelihood of eating celeriac', 'eating celeriac']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3853014', 'cui_str': 'Apium graveolens var. rapaceum'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1141640', 'cui_str': 'Carrots'}, {'cui': 'C3853014', 'cui_str': 'Apium graveolens var. rapaceum'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3853014', 'cui_str': 'Apium graveolens var. rapaceum'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",337.0,0.0440557,"Sensory play (congruent or incongruent) increased the odds of eating some celeriac in non-eaters compared to storybook only conditions. ","[{'ForeName': 'Chandani', 'Initials': 'C', 'LastName': 'Nekitsing', 'Affiliation': ''}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Blundell-Birtill', 'Affiliation': ''}, {'ForeName': 'Jennie E', 'Initials': 'JE', 'LastName': 'Cockroft', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Fildes', 'Affiliation': ''}, {'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Hetherington', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.017'] 1042,31013499,Effects of Acupuncture Treatment on Lower Limb Spasticity in Patients Following Hemorrhagic Stroke: A Pilot Study.,"BACKGROUND AND PURPOSE Lower limb spasticity is often a significant problem in stoke rehabilitation. The purpose of this study was to investigate the effects of acupuncture treatment on lower limb spasticity in patients following hemorrhagic stroke. METHODS Fifty-nine patients following hemorrhagic stroke were randomized to receive acupuncture treatment combined with conventional treatment (treatment group [TG]) or conventional treatment only (control group [CG]). Acupuncture treatments were given in 24 sessions over 4 weeks. Blinded evaluation was based on Modified Ashworth Scale (MAS), short intracortical inhibition (SICI), and Hmax/Mmax ratio as the primary outcomes. In addition, Fugl-Meyer Assessment (FMA), Barthel Index (BI), motor evoked potential (MEP) and surface integrated electromyogram (IEMG) were employed as the secondary outcomes. All the evaluations were performed at 14 and 28 days after the start of the treatment. RESULTS Compared with the CG, the TG showed a significantly greater over-time decrease in MAS for knee (p = 0.022) and ankle (p = 0.017), SICI (p = 0.000) and Hmax/Mmax ratio (p = 0.000). In all patients of TG, we found a greater improvement in lower-limb FMA and MEP but not in BI. IEMG show that TG obtained a greater reduction in spastic agonist muscles and a greater enhancement in spastic antagonist muscles. A significant correlation between a greater decrease in ankle MAS and a greater increase in SICI for spastic muscles was found (r = 0.390, p = 0.002). CONCLUSIONS Acupuncture could improve the lower limb spasticity and motor function, thus providing a safe and economical approach for treating stroke patients. The potential mechanism underpinning the greater improvement may be attributed to a reshape of corticospinal plasticity induced by acupuncture.",2019,"A significant correlation between a greater decrease in ankle MAS and a greater increase in SICI for spastic muscles was found (r = 0.390, p = 0.002). ","['patients following hemorrhagic stroke', 'Fifty-nine patients following hemorrhagic stroke', 'Patients Following Hemorrhagic Stroke']","['Acupuncture Treatment', 'acupuncture treatment combined with conventional treatment (treatment group [TG]) or conventional treatment only (control group [CG', 'Acupuncture', 'IEMG', 'acupuncture']","['spastic agonist muscles', 'SICI for spastic muscles', 'limb spasticity', 'Lower Limb Spasticity', 'Modified Ashworth Scale (MAS), short intracortical inhibition (SICI), and Hmax/Mmax ratio', 'lower-limb FMA and MEP', 'spastic antagonist muscles', 'Fugl-Meyer Assessment (FMA), Barthel Index (BI), motor evoked potential (MEP) and surface integrated electromyogram (IEMG', 'MAS for knee', 'Hmax/Mmax ratio', 'ankle MAS', 'SICI', 'lower limb spasticity and motor function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}]",59.0,0.107652,"A significant correlation between a greater decrease in ankle MAS and a greater increase in SICI for spastic muscles was found (r = 0.390, p = 0.002). ","[{'ForeName': 'Hai-Qiao', 'Initials': 'HQ', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China, haiqiaodr@163.com.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': ""Department of Neurology and Rehabilitation, Qingdao Women and Children's Hospital, Qingdao University, Qingdao, China.""}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Bao', 'Affiliation': 'Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}]",European neurology,['10.1159/000499133'] 1043,31209097,Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions.,"INTRODUCTION Severe hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence. METHODS AND ANALYSIS A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol. ETHICS AND DISSEMINATION The protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups. TRIAL REGISTRATION NUMBER NCY02940873; Pre-results.",2019,"A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services.","['96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services', 'People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc']","['HARPdoc versus Blood Glucose Awareness Training', 'Hypoglycaemia Awareness Restoration Programme', 'novel intervention addressing cognitions']","['rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures', 'SH rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0041657', 'cui_str': 'Unconscious State'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",96.0,0.118026,"A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services.","[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Amiel', 'Affiliation': ""Diabetes Department, Denmark Hill Campus, King's College London Faculty of Life Sciences and Medicine, London, UK.""}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""Diabetes Department, Denmark Hill Campus, King's College London Faculty of Life Sciences and Medicine, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jacob', 'Affiliation': ""Diabetes Department, Denmark Hill Campus, King's College London Faculty of Life Sciences and Medicine, London, UK.""}, {'ForeName': 'Emma Lauretta', 'Initials': 'EL', 'LastName': 'Smith', 'Affiliation': ""Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'De Zoysa', 'Affiliation': ""Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gonder-Frederick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Kendall', 'Affiliation': ""Diabetes Department, Denmark Hill Campus, King's College London Faculty of Life Sciences and Medicine, London, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'School of Medicine and Biomedical Sciences, University of Sheffield Faculty of Medicine Dentistry and Health, Sheffield, UK.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Brooks', 'Affiliation': 'Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Toschi', 'Affiliation': 'Joslin Diabetes Center, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Dulmini', 'Initials': 'D', 'LastName': 'Kariyawasam', 'Affiliation': ""Department of Diabetes, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Potts', 'Affiliation': 'Department of Biostatistics, Department of Health Services and Population Research, Institute of Psychiatry Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Healy', 'Affiliation': 'Department of Biostatistics, Department of Health Services and Population Research, Institute of Psychiatry Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rogers', 'Affiliation': ""Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Sevdalis', 'Affiliation': 'Centre for Implementation Science, Health Sciences and Population Research Department, Institute of Psychiatry Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Stadler', 'Affiliation': ""Diabetes Department, Denmark Hill Campus, King's College London Faculty of Life Sciences and Medicine, London, UK.""}, {'ForeName': 'Mustabshira', 'Initials': 'M', 'LastName': 'Qayyum', 'Affiliation': ""Diabetes Department, Denmark Hill Campus, King's College London Faculty of Life Sciences and Medicine, London, UK.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Bakolis', 'Affiliation': 'Department of Biostatistics, Department of Health Services and Population Research, Institute of Psychiatry Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': 'Department of Biostatistics, Department of Health Services and Population Research, Institute of Psychiatry Psychology and Neuroscience, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030356'] 1044,31378647,Taste Exposure Increases Intake and Nutrition Education Increases Willingness to Try an Unfamiliar Vegetable in Preschool Children: A Cluster Randomized Trial.,"BACKGROUND Intake of vegetables in children remains low. OBJECTIVE To compare taste exposure (TE), nutrition education (NE) and TE+NE together on intake of an unfamiliar vegetable (mooli/daikon radish) in preschool-aged children. DESIGN Children attending 11 preschools in England were randomly assigned by clusters to four intervention conditions using a 2×2 factorial design: TE, NE, TE+NE, and no intervention (control). PARTICIPANTS Two hundred nineteen children aged 2 to 5 years participated from September 2016 to June 2017. INTERVENTION The intervention period was 10 weeks preceded and followed by measurements of raw mooli intake as a snack. Preschools were randomized to receive weekly TE at snack time (n=62 children); NE (n=68) using the PhunkyFoods program; TE+NE (n=55) received both weekly taste exposures at snack and lessons from the PhunkyFoods program; and the control condition (n=34), received NE after the final follow-up measurement. MAIN OUTCOME MEASURES Individual measured intakes of mooli at Week 1 (baseline), Week 12 (postintervention), and Week 24 and Week 36 (follow-ups). STATISTICAL ANALYSIS Differences in intakes were analyzed by cluster. Logistic regressions were conducted to examine odds ratios for intake patterns. RESULTS Data from 140 children with complete mooli intake assessments were analyzed. TE increased intake from 4.7±1.4 g to 17.0±2.0 g and this was maintained at both follow-ups. Children assigned to the NE conditions were more likely to eat some of the mooli than children who were not in the NE conditions (odds ratio 6.43, 95% CI 1.5 to 27.8). Combining TE and NE produced no additional benefit to intake beyond TE alone. CONCLUSIONS Taste exposures encouraged children to eat more of the unfamiliar vegetable, whereas nutrition education encouraged children who were noneaters to try the vegetable. Both approaches were effective and can be used to produce different outcomes.",2019,"Children assigned to the NE conditions were more likely to eat some of the mooli than children who were not in the NE conditions (odds ratio 6.43, 95% CI 1.5 to 27.8).","['preschool-aged children', 'Preschool Children', 'Children attending 11 preschools in England', 'Two hundred nineteen children aged 2 to 5 years participated from September 2016 to June\xa02017', '140 children with complete mooli intake assessments', 'n=62 children); NE (n=68) using the']","['PhunkyFoods program; TE+NE (n=55) received both weekly taste exposures at snack and lessons from the PhunkyFoods program; and the control condition', 'TE at snack time', 'taste exposure (TE), nutrition education (NE) and TE+NE together on intake of an unfamiliar vegetable (mooli/daikon radish', 'TE, NE, TE+NE, and no intervention (control', 'NE']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0585041', 'cui_str': 'Snack time (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0330515', 'cui_str': 'Radish'}]",[],219.0,0.0781016,"Children assigned to the NE conditions were more likely to eat some of the mooli than children who were not in the NE conditions (odds ratio 6.43, 95% CI 1.5 to 27.8).","[{'ForeName': 'Chandani', 'Initials': 'C', 'LastName': 'Nekitsing', 'Affiliation': ''}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Blundell-Birtill', 'Affiliation': ''}, {'ForeName': 'Jennie E', 'Initials': 'JE', 'LastName': 'Cockroft', 'Affiliation': ''}, {'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Hetherington', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.012'] 1045,31197364,Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial.,"BACKGROUND Self-applied and professional fluorides are key elements to limit caries-related side-effects during orthodontic treatment with fixed appliances. OBJECTIVE To evaluate the effectiveness of a new fluoride varnish formula containing 1.5% ammonium fluoride in preventing white spot lesions (WSLs) in adolescents undergoing multi-bracket orthodontic treatment. SUBJECTS AND METHODS The study employed a randomized controlled triple-blinded design with two parallel arms. One hundred eighty-two healthy adolescents (12-18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled. Informed consent was obtained from 166 patients and they were randomly allocated to a test or a placebo group (with aid of a computer program, generating sequence numbers in blocks of 15). In the test group, fluoride varnish was applied in a thin layer around the bracket base every sixth week during the orthodontic treatment, while patients in the placebo group received a varnish without fluoride. The intervention started at onset of the fixed appliances and continued until debonding. The endpoint was prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score. RESULTS One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the placebo group (dropout rate 10.8%). The total prevalence of WSL's on subject level after debonding was 41.8% in the test group and 43.8% in the placebo group. The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1. LIMITATIONS The multicentre design with somewhat diverging routines at the different clinics may have increased risk for performance bias. No health-economic evaluation was carried out. CONCLUSIONS Regular applications of an ammonium fluoride varnish reduced the prevalence of advanced WSL during treatment with fixed orthodontic appliances. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov (NCT03725020). PROTOCOL The protocol was not published before trial commencement.",2020,"The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1. ","['166 patients', 'One hundred eighty-two healthy adolescents (12-18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled', 'white spot lesions during orthodontic treatment with fixed appliances', 'adolescents undergoing multi-bracket orthodontic treatment', 'One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the']","['placebo', 'fluoride varnish', 'varnish without fluoride', 'Fluoride varnish', 'new fluoride varnish formula containing 1.5% ammonium fluoride']","[""total prevalence of WSL's on subject level after debonding"", 'severe lesions', 'prevalence of advanced WSL', 'absolute risk reduction', 'prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score', 'white spot lesions (WSLs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0051717', 'cui_str': 'ammonium fluoride'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023759', 'cui_str': 'Lip'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}]",182.0,0.527974,"The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1. ","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sonesson', 'Affiliation': 'Department of Orthodontics, Faculty of Odontology, Malmö University.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brechter', 'Affiliation': 'Bernhold Ortodonti, Private Practice, Helsingborg, Sweden.'}, {'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Abdulraheem', 'Affiliation': 'Department of Orthodontics, Faculty of Odontology, Malmö University.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Lindman', 'Affiliation': 'Ortodonti Syd, Private Practice, Hässleholm, Sweden.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Twetman', 'Affiliation': 'Department of Odontology, Section for Cariology & Endodontics and Pediatric Dentistry & Clinical Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",European journal of orthodontics,['10.1093/ejo/cjz045'] 1046,31189509,"Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial.","BACKGROUND Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease. METHODS REWIND was a multicentre, randomised, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum values measured in local laboratories every 12 months. The primary outcome (first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes of this trial have been reported elsewhere. In this exploratory analysis, we investigate the renal component of the composite microvascular outcome, defined as the first occurrence of new macroalbuminuria (UACR >33·9 mg/mmol), a sustained decline in eGFR of 30% or more from baseline, or chronic renal replacement therapy. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). At baseline, 791 (7·9%) had macroalbuminuria and mean eGFR was 76·9 mL/min per 1·73 m 2 (SD 22·7). During a median follow-up of 5·4 years (IQR 5·1-5·9) comprising 51 820 person-years, the renal outcome developed in 848 (17·1%) participants at an incidence rate of 3·5 per 100 person-years in the dulaglutide group and in 970 (19·6%) participants at an incidence rate of 4·1 per 100 person-years in the placebo group (hazard ratio [HR] 0·85, 95% CI 0·77-0·93; p=0·0004). The clearest effect was for new macroalbuminuria (HR 0·77, 95% CI 0·68-0·87; p<0·0001), with HRs of 0·89 (0·78-1·01; p=0·066) for sustained decline in eGFR of 30% or more and 0·75 (0·39-1·44; p=0·39) for chronic renal replacement therapy. INTERPRETATION Long-term use of dulaglutide was associated with reduced composite renal outcomes in people with type 2 diabetes. FUNDING Eli Lilly and Company.",2019,"INTERPRETATION Long-term use of dulaglutide was associated with reduced composite renal outcomes in people with type 2 diabetes. ","['type 2 diabetes', 'Between Aug 18, 2011, and Aug 14, 2013, 9901 participants', 'Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors', 'people with type 2 diabetes', '371 sites in 24 countries', 'group (hazard ratio [HR', 'people with type 2 diabetes at risk for cardiovascular disease']","['placebo', 'GLP-1 receptor agonist dulaglutide', 'subcutaneous injection of dulaglutide (1·5 mg) or placebo', 'glucagon-like peptide-1', 'GLP-1) receptor agonists', 'dulaglutide']","['composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes', 'renal outcome', 'Dulaglutide and renal outcomes', 'macroalbuminuria and mean eGFR', 'Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs', 'renal outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3811844'}]",9901.0,0.759824,"INTERPRETATION Long-term use of dulaglutide was associated with reduced composite renal outcomes in people with type 2 diabetes. ","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumologie, Université Laval, Québec City, QC, Canada.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'ECLA, Estudios Clínicos Latinoamérica, Rosario, Argentina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': ""St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Fady T', 'Initials': 'FT', 'LastName': 'Botros', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health & Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia and University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Namsik', 'Initials': 'N', 'LastName': 'Chung', 'Affiliation': 'Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital MSWiA, Warsaw, Poland.'}, {'ForeName': 'Nicolae', 'Initials': 'N', 'LastName': 'Hancu', 'Affiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.'}, {'ForeName': 'Markolf', 'Initials': 'M', 'LastName': 'Hanefeld', 'Affiliation': 'Department of Internal Medicine, Dresden Technical University, Dresden, Germany.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Holt', 'Affiliation': 'Victoria University of Wellington, Wellington, New Zealand.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Research Institute, FOSCAL and Medical School, Universidad de Santander UDES, Bucaramanga, Colombia.'}, {'ForeName': 'Ernesto German', 'Initials': 'EG', 'LastName': 'Cardona Munoz', 'Affiliation': 'Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Centre, Sofia, Bulgaria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31150-X'] 1047,31786652,Pre-treatment ADC image-based random forest classifier for identifying resistant rectal adenocarcinoma to neoadjuvant chemoradiotherapy.,"OBJECTIVE To develop a predicting model for tumor resistance to neoadjuvant chemoradiotherapy (NCRT) in locally advanced rectal cancer (LARC) by using pre-treatment apparent diffusion coefficient (ADC) image-derived radiomics features. METHOD A total of 89 patients with LARC were randomly assigned into training (N = 66) and testing cohorts (N = 23) at the ratio of 3:1. Radiomics features were derived from manually determined tumor region of pre-treatment ADC images. Random forest algorithm was used to determine the most relevant features and then to construct a predicting model for identifying resistant tumor. Stability and diagnostic performance of the random forest model was evaluated with the testing cohort. RESULTS The top 10 most relevant features (entropy mean , inverse variance, energy mean , small area emphasis, ADC min , ADC mean , sdGa02, small gradient emphasis, age, and size) were determined from clinical characteristics and 133 radiomics features. In the prediction of resistant tumor of the testing cohort, the random forest model constructed based on these most relevant features achieved an area under the receiver operating characteristic curve of 0.83, with the highest accuracy of 91.3%, a sensitivity of 88.9%, and a specificity of 92.8%. CONCLUSION The random forest classifier based on radiomics features derived from pre-treatment ADC images have the potential to predict tumor resistance to NCRT in patients with LARC, and the use of predicting model may facilitate individualized management of rectal cancer.",2020,"OBJECTIVE To develop a predicting model for tumor resistance to neoadjuvant chemoradiotherapy (NCRT) in locally advanced rectal cancer (LARC) by using pre-treatment apparent diffusion coefficient (ADC) image-derived radiomics features. ","['89 patients with LARC', 'locally advanced rectal cancer (LARC']","['Pre-treatment ADC image-based random forest classifier', 'neoadjuvant chemoradiotherapy (NCRT', 'neoadjuvant chemoradiotherapy']","['Stability and diagnostic performance', 'energy mean , small area emphasis, ADC min , ADC mean , sdGa02, small gradient emphasis, age, and size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0086312', 'cui_str': 'Forestlands'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",89.0,0.0487211,"OBJECTIVE To develop a predicting model for tumor resistance to neoadjuvant chemoradiotherapy (NCRT) in locally advanced rectal cancer (LARC) by using pre-treatment apparent diffusion coefficient (ADC) image-derived radiomics features. ","[{'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, No. 180, Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Ze-Kun', 'Initials': 'ZK', 'LastName': 'Jiang', 'Affiliation': 'Shandong Key Laboratory of Medical Physics and Image Processing Technology, School of Physics and Electronics, Shandong Normal University, Jinan, Shandong, China.'}, {'ForeName': 'Li-Heng', 'Initials': 'LH', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, No. 180, Fenglin Road, Shanghai, 200032, China. llh9821@163.com.'}, {'ForeName': 'Meng-Su', 'Initials': 'MS', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, No. 180, Fenglin Road, Shanghai, 200032, China.'}]",International journal of colorectal disease,['10.1007/s00384-019-03455-3'] 1048,30853354,Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial: Design and rationale.,"BACKGROUND Although extensive substrate modification in addition to pulmonary vein isolation (PVI) has been recommended in catheter ablation for persistent atrial fibrillation (AF), recent randomized controlled trials have not demonstrated efficacy of such additional ablations. METHODS AND STUDY DESIGN The Osaka Cardiovascular Conference will conduct a multicenter, randomized, open-label trial aiming to examine whether PVI alone is non-inferior to PVI plus additional ablation such as linear ablation and/or complex fractionated atrial electrogram ablation in patients with persistent AF. The primary outcome is recurrence of AF documented by scheduled or symptom-driven electrocardiogram tests during a 1-year follow-up period after the index ablation. The key secondary endpoints include all-cause death, occurrence of symptomatic stroke, complications related to the procedure, and quality of life assessment using the 36-item Short-Form Health Survey. The clinical impact of the presence or absence of AF trigger foci, and their origins in cases with them, on the results of catheter ablation will also be investigated as an exploratory endpoint. A total of 512 patients will be enrolled and followed up to 1 year. CONCLUSIONS The EARNEST-PVI trial is a randomized controlled trial designed to assess whether PVI alone is non-inferior to extended substrate ablation for patients with persistent AF undergoing a first catheter ablation.",2019,The EARNEST-PVI trial is a randomized controlled trial designed to assess whether PVI alone is non-inferior to extended substrate ablation for patients with persistent AF undergoing a first catheter ablation.,"['512 patients will be enrolled and followed up to 1 year', 'patients with persistent AF', 'Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation (EARNEST-PVI) trial', 'patients with persistent AF undergoing a first catheter ablation']","['PVI alone', 'Extensive Ablation']","['cause death, occurrence of symptomatic stroke, complications related to the procedure, and quality of life assessment using the 36-item Short-Form Health Survey', 'recurrence of AF documented by scheduled or symptom-driven electrocardiogram tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",512.0,0.144063,The EARNEST-PVI trial is a randomized controlled trial designed to assess whether PVI alone is non-inferior to extended substrate ablation for patients with persistent AF undergoing a first catheter ablation.,"[{'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Dohi', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Daisaku', 'Initials': 'D', 'LastName': 'Nakatani', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Shungo', 'Initials': 'S', 'LastName': 'Hikoso', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan; Department of Medical Therapeutics for Heart Failure, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: hikoso@cardiology.med.osaka-u.ac.jp.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Oka', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Keio University, Department of Mathematics, Yokohama, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Egami', 'Affiliation': 'Division of Cardiology, Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Kashiwase', 'Affiliation': 'Cardiovascular Division, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Hirata', 'Affiliation': 'Cardiovascular Division, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiology, Osaka Hospital, Japan Community Healthcare Organization, Osaka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Takeda', 'Affiliation': 'Department of Medical Informatics, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Informatics, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Mizuno', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minamiguchi', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Department of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Suna', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kojima', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hirota', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Oeun', 'Initials': 'O', 'LastName': 'Bolrathanak', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Okuyama', 'Affiliation': 'Cardiovascular Division, Osaka Minami Medical Center, Kawachinagano, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiology,['10.1016/j.jjcc.2019.01.010'] 1049,31189511,"Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.","BACKGROUND Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A 1c (HbA 1c ) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control. METHODS This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA 1c 7·2% [IQR 6·6-8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79-0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001). INTERPRETATION Dulaglutide could be considered for the management of glycaemic control in middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors. FUNDING Eli Lilly and Company.",2019,"All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067).","['Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors', '46·3%] women', 'type 2 diabetes (REWIND', '371 sites in 24 countries', 'individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control', 'middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors', 'Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA 1c 7·2% [IQR 6·6-8·1], 4589', 'people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin']","['placebo', 'GLP-1 receptor agonist dulaglutide', 'subcutaneous injection of dulaglutide (1·5 mg) or placebo', 'glucagon-like peptide-1', 'GLP-1) receptor agonists', 'dulaglutide']","['All-cause mortality', 'cardiovascular outcomes', 'gastrointestinal adverse event', 'first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population', 'Dulaglutide and cardiovascular outcomes']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}]",9901.0,0.806952,"All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067).","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumologie, Université Laval, Québec City, QC, Canada.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'ECLA, Estudios Clínicos Latinoamérica, Rosario, Argentina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': ""St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Riesmeyer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health & Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia and University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Namsik', 'Initials': 'N', 'LastName': 'Chung', 'Affiliation': 'Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital MSWiA, Warsaw, Poland.'}, {'ForeName': 'Nicolae', 'Initials': 'N', 'LastName': 'Hancu', 'Affiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.'}, {'ForeName': 'Markolf', 'Initials': 'M', 'LastName': 'Hanefeld', 'Affiliation': 'Department of Internal Medicine, Dresden Technical University, Dresden, Germany.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Holt', 'Affiliation': 'Victoria University of Wellington, Wellington, New Zealand.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Research Institute, FOSCAL and Medical School, Universidad de Santander UDES, Bucaramanga, Colombia.'}, {'ForeName': 'Ernesto German', 'Initials': 'EG', 'LastName': 'Cardona Munoz', 'Affiliation': 'Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Centre, Sofia, Bulgaria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31149-3'] 1050,30997657,Comparative analysis of microleakage of temporary filling materials used for multivisit endodontic treatment sessions in primary teeth: an in vitro study.,"PURPOSE Coronal leakage is an important factor contributing to the failure of endodontic treatment. The use of an efficient temporary restoration between sessions of multiple-visit pulpectomies is irrefutable. Two cements have long been used in endodontics-IRM, which is a reinforced zinc oxide cement and Cavit G, a calcium sulphate based cement. The aim of this study was to compare the microleakage of nano silver containing UDMA-based cements with routinely used zinc oxide and calcium sulphate-based temporary cements in primary teeth. METHODS Standardized access cavities of 3 × 3 mm were prepared in the sixty caries-free primary molars. The teeth were divided randomly into four groups of 14 teeth each-Group I: IRM, Group II: Cavit G, Group III: Orafil-G and Group IV: Dia-Temp. Temporary restorative materials were applied according to the manufacturer's instructions. The teeth were subjected to thermocycling and then immersed in 0.5% basic fuchsin for 24 h. The specimens were sectioned and evaluated under a digital microscope at 20× magnification and were scored for microleakage. The collected data were tabulated and subjected to statistical analysis. RESULTS Dia-Temp presented the least microleakage values. The highest score for microleakage was shown by IRM followed by Orafil-G and Cavit-G. There was a significant difference between IRM and Diatemp groups (p value = 0.009), and among Orafil G and Diatemp groups (p value = 0.025). CONCLUSION Among the four materials tested, Dia-Temp exhibited the best sealing ability and its use is recommended in between sessions of endodontic treatment in primary teeth.",2019,The highest score for microleakage was shown by IRM followed by Orafil-G and Cavit-G.,"['Standardized access cavities of 3\u2009×\u20093\xa0mm were prepared in the sixty caries-free primary molars', 'primary teeth']","['Cavit G, Group III: Orafil-G and Group IV: Dia-Temp', 'multivisit endodontic treatment sessions', 'nano silver containing UDMA-based cements with routinely used zinc oxide and calcium sulphate-based temporary cements']",[],"[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}]","[{'cui': 'C0054898', 'cui_str': 'Cavit G'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0172658', 'cui_str': '4-(4-dihexadecylaminostyryl)N-methylpyridium iodide'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}]",[],60.0,0.0131306,The highest score for microleakage was shown by IRM followed by Orafil-G and Cavit-G.,"[{'ForeName': 'N S V', 'Initials': 'NSV', 'LastName': 'Babu', 'Affiliation': 'Department of Pediatric and Preventive dentistry, Vokkaligara Sangha Dental College and Hospital, Bangalore, Karnataka, 560004, India. drnsvbabu@gmail.com.'}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Bhanushali', 'Affiliation': 'Department of Pediatric and Preventive dentistry, Vokkaligara Sangha Dental College and Hospital, Bangalore, Karnataka, 560004, India.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Bhanushali', 'Affiliation': 'Terna Dental College and Hospital, Nerul, Navi Mumbai, Maharashtra, 400706, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Pediatric and Preventive dentistry, Vokkaligara Sangha Dental College and Hospital, Bangalore, Karnataka, 560004, India.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-019-00436-6'] 1051,31029455,Clinical comparative study regarding interrupted and uninterrupted dabigatran therapy during perioperative periods of cryoballoon ablation for paroxysmal atrial fibrillation.,"BACKGROUND Catheter manipulation in the left-sided heart is known as a risk for cerebral embolisms (CEs). However, anticoagulation therapy is terminated before catheter ablation (CA) of atrial fibrillation (AF) concerning adverse bleeding events. Little is known whether uninterrupted direct oral anticoagulants (DOACs) during perioperative period of CA could render the ablation procedure safer and reduce the incidence of CEs compared to interrupted DOACs. The aim of this study was to investigate the safety and usefulness of uninterrupted dabigatran during the periprocedural period for CA of AF. METHODS We included 333 patients with paroxysmal AF undergoing cryoballoon CA (CBA). They were prospectively divided into 2 groups based on whether DOACs were interrupted on the day of the CA (Group A, n=228) or dabigatran was not interrupted throughout perioperative period (Group B, n=105) in a non-randomized fashion. When the Group B patients had taken other DOACs rather than dabigatran before assignment, we changed those DOACs to dabigatran. Brain magnetic resonance imaging (MRI) was undertaken on the following day of the CA. Serious bleeding event cases were excluded from the study. RESULTS The baseline characteristics including the CHADs2 score did not exhibit any significant differences between the groups. The brain MRI revealed an acute CEs in 82 patients, and was significantly higher in Group A than B (29% vs. 13%, respectively, p<0.01). There were no significant differences regarding the bleeding events (7% vs. 4%, respectively, p=0.62). CONCLUSION Uninterrupted dabigatran therapy during the CBA of paroxysmal AF could significantly reduce the incidence of CEs.",2019,"There were no significant differences regarding the bleeding events (7% vs. 4%, respectively, p=0.62). ","['paroxysmal atrial fibrillation', '333 patients with paroxysmal AF undergoing cryoballoon CA (CBA']","['CA', 'dabigatran', 'interrupted and uninterrupted dabigatran therapy', 'Brain magnetic resonance imaging (MRI', 'uninterrupted dabigatran', 'cryoballoon ablation']","['CHADs2 score', 'incidence of CEs', 'bleeding events', 'brain MRI revealed an acute CEs']","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C2585876', 'cui_str': 'CHADS2 score'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}]",333.0,0.0205759,"There were no significant differences regarding the bleeding events (7% vs. 4%, respectively, p=0.62). ","[{'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Okishige', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan. Electronic address: okishige@yo.rim.or.jp.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Shigeta', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kurabayashi', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasuteru', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, Yokohama, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Sasano', 'Affiliation': 'Arrhythmia Center, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Arrhythmia Center, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.02.003'] 1052,30904993,Evaluation of remineralisation potential of experimental nano hydroxyapatite pastes using scanning electron microscope with energy dispersive X-ray analysis: an in-vitro trial.,"AIM To analyse the remineralisation potential of experimental nano hydroxyapatite (nHAP) paste on artificial caries lesions using scanning electron microscope (SEM) with energy dispersive X-ray analysis (EDX). METHODS Sixty-five enamel specimens were randomly divided into 4 test groups (n = 15): 1% commercially available nHAP paste (CnHAP) group, 1% experimental nHAP paste (EnHAP) group, 10% EnHAP group, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) group and control group (n = 5). Artificial carious lesions were induced in all the specimens and treated with respective paste twice daily for 14 days. The specimens were subjected to EDX analysis at baseline, after demineralisation and after remineralisation. The surface characteristics of the remineralised enamel specimens were evaluated by SEM. RESULTS All the test groups showed significant change in calcium and phosphorus weight percentage (wt%) after remineralisation. The 10 % EnHAP showed higher mean value of calcium and phosphorus wt% followed by 1% CnHAP, 1% EnHAP and CPP-ACP. After remineralisation, both 10% EnHAP and CPP-ACP showed favourable enamel surface changes in SEM analysis. CONCLUSION Commercially available and experimental nHAP have the potential to remineralise artificially induced carious lesions.",2019,"After remineralisation, both 10% EnHAP and CPP-ACP showed favourable enamel surface changes in SEM analysis. ",['Sixty-five enamel specimens'],"['available nHAP paste (CnHAP) group, 1% experimental nHAP paste (EnHAP) group, 10% EnHAP group, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP', 'scanning electron microscope (SEM) with energy dispersive X-ray analysis (EDX', 'experimental nano hydroxyapatite (nHAP) paste', 'nHAP', 'scanning electron microscope with energy dispersive X-ray analysis']","['calcium and phosphorus weight percentage', 'higher mean value of calcium and phosphorus', 'Artificial carious lesions']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0645108', 'cui_str': 'NHAP'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'Ca9(PO4)6'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0181845', 'cui_str': 'Electron microscope'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}]",65.0,0.0128437,"After remineralisation, both 10% EnHAP and CPP-ACP showed favourable enamel surface changes in SEM analysis. ","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vijayasankari', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, 637215, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Asokan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, 637215, India. asokansharath@yahoo.com.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'GeethaPriya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, 637215, India.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-018-00411-7'] 1053,31163319,Attachment-related attention bias plays a causal role in trust in maternal support.,"The current study was designed to test whether children's ability to flexibly shift their attention (from their mother during distress to peers during exploration and vice versa) causally increases children's trust in the mother's support. We trained attention flexibility using a gaze-contingent music reward design. A total of 85 children (9-13 years of age; 46% boys) were randomly assigned to this training or a comparable yoked control condition. Attentional preferences were measured via eye tracking. Before and after the manipulation, we measured self-reported trust. Results showed that the training condition increased children's attention flexibility. Training-related increased attentional focus on the mother during distress was linked with increased trust.",2019,Training-related increased attentional focus on the mother during distress was linked with increased trust.,['85 children (9-13\u202fyears of age; 46% boys'],[],"['Attentional preferences', ""children's attention flexibility""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]",[],"[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",85.0,0.0268242,Training-related increased attentional focus on the mother during distress was linked with increased trust.,"[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Bosmans', 'Affiliation': 'Parenting and Special Education Research Group, KU Leuven, 3000 Leuven, Belgium. Electronic address: guy.bosmans@kuleuven.be.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Sanchez-Lopez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, 9000 Gent, Belgium; Department of Clinical Psychology, Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Finet', 'Affiliation': 'Parenting and Special Education Research Group, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, 9000 Gent, Belgium.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.04.017'] 1054,31173551,Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial.,"PURPOSE In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy. PATIENTS AND METHODS A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (g BRCA mut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed g BRCA mut (non-g BRCA mut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to g BRCA mut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index. RESULTS Progression-free survival was improved in patients treated with niraparib compared with placebo in both the g BRCA mut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-g BRCA mut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes. CONCLUSION Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.",2019,"No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes. ","['patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy', 'patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy', 'Patients With Recurrent Ovarian Cancer', '203 patients with a germline BRCA mutation (g BRCA mut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed g BRCA mut (non-g BRCA mut), 173 had a PR and 177 had a CR', 'A total of 553 patients were enrolled in the trial']","['Niraparib Maintenance Therapy', 'Last Platinum-Based Chemotherapy', 'placebo']","['incidence of any-grade and grade 3 or greater adverse events', 'Ovarian cancer-specific symptoms and quality of life', 'Progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",553.0,0.0700869,"No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes. ","[{'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Malander', 'Affiliation': 'Nordic Society of Gynaecological Oncology (NSGO) and Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': ""Centre Hospitalier de L'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Follana', 'Affiliation': ""Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Centre Antoine Lacassagne, Nice, France.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Waters', 'Affiliation': 'National Cancer Research Institute (NCRI) and Kent Oncology Centre, Maidstone Hospital, Kent, United Kingdom.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Berek', 'Affiliation': ""Stanford Women's Cancer Center, Stanford Cancer Institute, Stanford, CA.""}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Woie', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': 'AGO and Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gil-Martin', 'Affiliation': ""GEICO and Institut Català d'Oncologia-IDIBELL, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lesoin', 'Affiliation': 'GINECO and Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St Joseph's Hospital, Phoenix, AZ.""}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': 'NSGO and Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'McGill University, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Benigno', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'TESARO: A GSK Company, Waltham, MA.'}, {'ForeName': 'Sebastien J', 'Initials': 'SJ', 'LastName': 'Hazard', 'Affiliation': 'TESARO: A GSK Company, Waltham, MA.'}, {'ForeName': 'Mansoor R', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'NSGO and Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02238'] 1055,31176632,Pharmacokinetics and efficacy of a novel formulation of carbidopa-levodopa (Accordion Pill ® ) in Parkinson's disease.,"INTRODUCTION Dopamine replacement via levodopa (LD) remains the most effective treatment for Parkinson's disease (PD), yet its use is often associated with motor complications within several years of continued use. The Accordion Pill ® (AP-CD/LD) is a novel drug delivery system based on gastric retention of multilayer films containing immediate-release (IR) carbidopa (CD) and immediate- and controlled-release LD. The AP-CD/LD was designed to improve the consistency of LD in the bloodstream while offering patients with PD more consistent symptom management. METHODS This phase 2, multicenter, open-label, two-way randomized crossover study included 4 cohorts of participants with PD, each receiving AP-CD/LD (50/250 mg, 50/375 mg or 50/500 mg) twice daily in one treatment period and an active comparator in the other treatment period. Pharmacokinetics (PK) and efficacy were evaluated for AP-CD/LD vs IR-CD/LD. Treatment-emergent adverse events (TEAEs) and patient- and investigator-reported measures were also evaluated. RESULTS Compared with IR-CD/LD, treatment with either AP-CD/LD dose resulted in more stable LD plasma concentrations in both fluctuating and non-fluctuating PD patients, and significantly decreased C max (57.1% and 66.8% decreases among fluctuating and non-fluctuating patients, respectively). Both AP doses significantly improved standard measures of motor symptoms: (daily OFF time, total ON time, and good ON time), as well as patient- and investigator-assessed measures, versus IR-CD/LD. The safety and tolerability profile of AP-CD/LD was consistent with the known properties of IR-CD/LD. CONCLUSIONS AP technology demonstrated effective controlled-release PK performance and reduced motor response fluctuations in advanced PD patients. A phase 3 randomized controlled trial is currently underway.",2019,The Accordion Pill ® (AP-CD/LD) is a novel drug delivery system based on gastric retention of multilayer films containing immediate-release (IR) carbidopa (CD) and immediate- and controlled-release LD.,"['advanced PD patients', ""Parkinson's disease"", '4 cohorts of participants with PD, each receiving AP-CD/LD (50/250\u202fmg, 50/375\u202fmg or 50/500\u202fmg) twice daily in one treatment period and an active comparator in the other treatment period', ""Parkinson's disease (PD""]","['carbidopa-levodopa (Accordion Pill ® ', 'Dopamine replacement via levodopa (LD']","['standard measures of motor symptoms: (daily OFF time, total ON time, and good ON time', 'effective controlled-release PK performance', 'motor response fluctuations', 'C max', 'stable LD plasma concentrations', 'Pharmacokinetics (PK) and efficacy']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0353697', 'cui_str': 'Carbidopa / Levodopa'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0216964,The Accordion Pill ® (AP-CD/LD) is a novel drug delivery system based on gastric retention of multilayer films containing immediate-release (IR) carbidopa (CD) and immediate- and controlled-release LD.,"[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'LeWitt', 'Affiliation': 'Departments of Neurology, Henry Ford Hospital and Wayne State University School of Medicine, 6777 West Maple Road, West Bloomfield, MI, 38322, USA. Electronic address: plewitt1@hfhs.org.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Giladi', 'Affiliation': 'Neurological Institute, Tel Aviv Medical Center, Sackler School of Medicine, Sagol School of Neuroscience, Tel Aviv University, Israel.'}, {'ForeName': 'Nadav', 'Initials': 'N', 'LastName': 'Navon', 'Affiliation': 'Intec Pharma, Ltd, Hartom 12, POB 45219, Jerusalem, 91450, Israel.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.05.032'] 1056,31180620,"Repetitive transcranial magnetic stimulation for functional tremor: A randomized, double-blind, controlled study.","OBJECTIVES The objective of this study was to compare the effect on functional tremor of active versus sham repetitive transcranial magnetic stimulation and investigate whether the addition of hypnosis might help to prolong any repetitive transcranial magnetic stimulation-induced therapeutic effect. METHODS We compared the effect of 5 consecutive daily sessions of active/sham repetitive transcranial magnetic stimulation on functional tremor, at 1 and 2 months, in a randomized, double-blind, 2-arm, parallel-controlled study. In a second open-label phase, all patients underwent 3 weekly sessions of hypnosis combined with single sessions of real repetitive transcranial magnetic stimulation. The primary outcome was a change in the Psychogenic Movement Disorder Rating Scale at month 1 when compared with baseline. Secondary outcomes were changes in the Psychogenic Movement Disorder Rating Scale and Tremor subscores, the 36-item Short Form Health Survey, the Self-Report Hospital Anxiety and Depression Scale, the Hamilton Depression Rating Scale, and the Clinical Global Impression Scale assessed at months 1, 2, 6, and 12. RESULTS A total of 33 outpatients affected by functional tremor were screened, and 18 outpatients fulfilling the inclusion criteria (8 men, 10 women) were randomized. One month after the intervention, the mean Psychogenic Movement Disorder Rating Scale score had decreased in both groups, but the differences from baseline were only significant in the active repetitive transcranial magnetic stimulation group (P < .001). This remained significant at month 2 (P < .001). The significant decrease of the Psychogenic Movement Disorder Rating Scale and Tremor subscores were maintained at months 6 and 12 for the active repetitive transcranial magnetic stimulation group. For the control group, the Psychogenic Movement Disorder Rating Scale score had returned almost to its baseline value by month 2 and remained unchanged at months 6 and 12. CONCLUSION Repetitive transcranial magnetic stimulation could represent a valuable therapeutic option in the management of functional tremor. © 2019 International Parkinson and Movement Disorder Society.",2019,The significant decrease of the Psychogenic Movement Disorder Rating Scale and Tremor subscores were maintained at months 6 and 12 for the active repetitive transcranial magnetic stimulation group.,"['functional tremor', '33 outpatients affected by functional tremor were screened, and 18 outpatients fulfilling the inclusion criteria (8 men, 10 women']","['hypnosis combined with single sessions of real repetitive transcranial magnetic stimulation', 'active/sham repetitive transcranial magnetic stimulation', 'Repetitive transcranial magnetic stimulation', 'active versus sham repetitive transcranial magnetic stimulation']","['Psychogenic Movement Disorder Rating Scale score', 'Psychogenic Movement Disorder Rating Scale and Tremor subscores', 'mean Psychogenic Movement Disorder Rating Scale score', 'Psychogenic Movement Disorder Rating Scale', 'Psychogenic Movement Disorder Rating Scale and Tremor subscores, the 36-item Short Form Health Survey, the Self-Report Hospital Anxiety and Depression Scale, the Hamilton Depression Rating Scale, and the Clinical Global Impression Scale']","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3267131', 'cui_str': 'Psychogenic movement disorder'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}]",33.0,0.229356,The significant decrease of the Psychogenic Movement Disorder Rating Scale and Tremor subscores were maintained at months 6 and 12 for the active repetitive transcranial magnetic stimulation group.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Taib', 'Affiliation': 'Psychiatry and Medical Psychology Department, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Ory-Magne', 'Affiliation': 'Toulouse NeuroImaging Center, Toulouse University-Institut National de la Santé et de la Recherche Médicale (INSERM)-University of Toulouse, Toulouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brefel-Courbon', 'Affiliation': 'Toulouse NeuroImaging Center, Toulouse University-Institut National de la Santé et de la Recherche Médicale (INSERM)-University of Toulouse, Toulouse, France.'}, {'ForeName': 'Ysé', 'Initials': 'Y', 'LastName': 'Moreau', 'Affiliation': 'Toulouse NeuroImaging Center, Toulouse University-Institut National de la Santé et de la Recherche Médicale (INSERM)-University of Toulouse, Toulouse, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Thalamas', 'Affiliation': 'Clinical Investigation Center, Toulouse University Hospital, INSERM, Toulouse, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Arbus', 'Affiliation': 'Psychiatry and Medical Psychology Department, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simonetta-Moreau', 'Affiliation': 'Toulouse NeuroImaging Center, Toulouse University-Institut National de la Santé et de la Recherche Médicale (INSERM)-University of Toulouse, Toulouse, France.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27727'] 1057,31763933,Pathways to Recovery among Homeless People with Mental Illness: Is Impulsiveness Getting in the Way?,"OBJECTIVE This study investigates the association between impulsiveness and six dimensions of recovery among homeless people with mental illness. METHOD The sample was composed of 418 participants of a randomized controlled trial of Housing First, a recovery-oriented program that provides immediate access to permanent housing. The reliable change index method was used to provide an estimate of the statistical and clinical significance of the change from baseline to 24 months (i.e., clinically meaningful improvement), on outcomes that pertain to recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential). We tested for the effect of impulsiveness, assessed with the Barratt Impulsiveness Scale-11, on clinically meaningful improvement on each specific outcome, adjusting for age, gender and intervention assignment, as both intervention arms were included in the analysis. RESULTS For every increase in total impulsiveness score by one standard deviation, the odds of experiencing clinically meaningful improvement decreased by 29% ( OR = 0.71, 95% CI, 0.55 to 0.91) on the clinical dimension and by 53% ( OR = 0.47, 95% CI, 0.32 to 0.68) on the existential dimension. However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness. CONCLUSIONS Findings highlight the importance of addressing impulsiveness in the context of recovery-oriented interventions for homeless people with mental illness. Further research may be required to improve interventions that are responsive to unique needs of impulsive individuals to support clinical and existential recovery.",2020,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness. ","['418 participants', 'homeless people with mental illness', 'Homeless People with Mental Illness']",[],"['recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential', 'physical, functional, criminological, and social dimensions', 'total impulsiveness score']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",418.0,0.0674948,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness. ","[{'ForeName': 'Marichelle C', 'Initials': 'MC', 'LastName': 'Leclair', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Lemieux', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Roy', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': 'Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Crocker', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719885477'] 1058,31178421,"Inhaled hypertonic saline in preschool children with cystic fibrosis (SHIP): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND Inhaled hypertonic saline enhances mucociliary clearance, improves lung function, and reduces pulmonary exacerbations in people with cystic fibrosis older than age 6 years. We aimed to assess the effect of inhaled hypertonic saline on the lung clearance index (LCI 2·5 )-a measure of ventilation inhomogeneity-in children aged 3-6 years with cystic fibrosis. METHODS The Saline Hypertonic in Preschoolers (SHIP) Study was a randomised, double-blind, placebo-controlled trial at 25 cystic fibrosis centres in Canada and the USA. Eligible participants were aged 36-72 months; had a confirmed diagnosis of cystic fibrosis; were able to comply with medication use, study visits, and study procedures; and were able to complete at least two technically acceptable trials of multiple breath washout (MBW). Participants were randomly assigned (1:1) via a web-based data entry system that confirmed enrolment eligibility to inhaled 7% hypertonic saline or 0·9% isotonic saline nebulised twice daily (for no more than 15 min per dose) for 48 weeks. Permuted block randomisation was done separately for participants aged 36-54 months and those aged 55-72 months to ensure approximate balance by treatment group in the two age groups. The primary endpoint was the change in the LCI 2·5 measured by nitrogen MBW from baseline to week 48. All study sites were trained and certified in MBW. Analysis was by intention to treat. This study is registered with Clinicaltrials.gov, number NCT02378467. FINDINGS Between April 21, 2015, and Aug 4, 2017, 150 participants were enrolled and randomly assigned, 76 to the hypertonic saline group and 74 to the isotonic saline group. Overall 89% of the MBW tests produced acceptable data. At 48 weeks, treatment with hypertonic saline was associated with a significant decrease (ie, improvement) in LCI 2·5 compared with isotonic saline (mean treatment effect -0·63 LCI 2·5 units [95% CI -1·10 to -0·15]; p=0·010). Six participants in the hypertonic saline group had ten serious adverse events and eight participants in the isotonic saline group had nine serious adverse events. The serious adverse events reported were cough (two patients [3%] in the hypertonic saline group vs three [4%] in the isotonic saline group), gastrostomy tube placement or rupture (two [3%] vs one [1%]), upper gastrointestinal disorders (one [1%] vs two [3%]), distal intestinal obstruction syndrome (one [1%] vs one [1%]), and decreased pulmonary function (none vs one [1%]). None of these serious adverse events was judged to be treatment related. INTERPRETATION Inhaled hypertonic saline improved the LCI 2·5 in children aged 3-6 years, and could be a suitable early intervention in cystic fibrosis. FUNDING Cystic Fibrosis Foundation.",2019,"At 48 weeks, treatment with hypertonic saline was associated with a significant decrease (ie, improvement) in LCI 2·5 compared with isotonic saline (mean treatment effect -0·63","['people with cystic fibrosis older than age 6 years', 'participants aged 36-54 months and those aged 55-72 months to ensure approximate balance by treatment group in the two age groups', 'preschool children with cystic fibrosis (SHIP', 'Eligible participants were aged 36-72 months; had a confirmed diagnosis of cystic fibrosis', 'Between April 21, 2015, and Aug 4, 2017, 150 participants were enrolled and randomly assigned, 76 to the', 'children aged 3-6 years with cystic fibrosis', 'children aged 3-6 years', '25 cystic fibrosis centres in Canada and the USA']","['inhaled hypertonic saline', 'placebo', 'isotonic saline', 'hypertonic saline or 0·9% isotonic saline nebulised twice daily', 'hypertonic saline', 'Saline Hypertonic', 'Inhaled hypertonic saline']","['pulmonary exacerbations', 'pulmonary function', 'gastrostomy tube placement or rupture', 'nine serious adverse events', 'upper gastrointestinal disorders', 'change in the LCI 2·5 measured by nitrogen MBW', 'serious adverse events', 'lung clearance index (LCI 2·5 )-a measure of ventilation inhomogeneity', 'distal intestinal obstruction syndrome']","[{'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0036971', 'cui_str': 'Ships'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0150595', 'cui_str': 'Gastrostomy tube (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0810300', 'cui_str': 'Upper gastrointestinal disorder'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0398349', 'cui_str': 'Distal intestinal obstruction syndrome (disorder)'}]",150.0,0.616061,"At 48 weeks, treatment with hypertonic saline was associated with a significant decrease (ie, improvement) in LCI 2·5 compared with isotonic saline (mean treatment effect -0·63","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ratjen', 'Affiliation': 'Division of Respiratory Medicine, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON Canada; University of Toronto, Toronto, ON, Canada; Translational Medicine, Research Institute, SickKids, Toronto, ON, Canada. Electronic address: felix.ratjen@sickkids.ca.'}, {'ForeName': 'Stephanie D', 'Initials': 'SD', 'LastName': 'Davis', 'Affiliation': 'Division of Pediatric Pulmonology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Stanojevic', 'Affiliation': 'University of Toronto, Toronto, ON, Canada; Translational Medicine, Research Institute, SickKids, Toronto, ON, Canada.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Kronmal', 'Affiliation': 'Collaborative Health Studies Coordinating Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Hinckley Stukovsky', 'Affiliation': 'Collaborative Health Studies Coordinating Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Jorgensen', 'Affiliation': 'Collaborative Health Studies Coordinating Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenfeld', 'Affiliation': ""Division of Pulmonary Medicine, Seattle Children's Hospital, Seattle, WA, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30187-0'] 1059,30680633,A pilot randomized controlled trial of 6-week combined exercise program on fasting insulin and fitness levels in individuals with spinal cord injury.,"PURPOSE The aim of this randomized controlled trial study was to investigate the effect of combined exercise program on the fasting insulin and fitness levels of people with spinal cord injury (SCI). METHODS A total of 19 individuals with SCI participated in a combined exercise program consisting of aerobic and resistance exercises for 60 min per day, 3 days per week for 6 weeks. Peak oxygen consumption, body mass index, percent body fat, waist circumference, shoulder abduction and adduction, shoulder flexion and extension, elbow flexion and extension, fasting insulin levels, and homeostasis model assessment of insulin resistance (HOMA-IR) levels were measured at baseline and after the intervention. RESULTS The 6-week exercise program significantly decreased the average fasting insulin (baseline: 7.5 ± 4.7 µU/ml vs. post-intervention: 4.5 ± 2.2 µU/ml, p < 0.05) and HOMA-IR (baseline: 1.5 ± 1.0 vs. post-intervention: 0.9 ± 0.4, p < 0.05) in the exercise group, whereas there was no change in control group (between group difference, mean fasting insulin: - 3.2 µU/ml, p = 0.003; mean HOMA-IR: - 0.66, p = 0.001). In addition, muscle strength of the shoulder flexors, extensors, abductors, adductors, and elbow flexors was significantly improved in the exercise group compared to the controls. CONCLUSION A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI. These slides can be retrieved under Electronic Supplementary Material.",2019,A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI.,"['people with spinal cord injury (SCI', '19 individuals with SCI participated in a', 'individuals with spinal cord injury']","['combined exercise program', 'combined exercise program consisting of aerobic and resistance exercises']","['Peak oxygen consumption, body mass index, percent body fat, waist circumference, shoulder abduction and adduction, shoulder flexion and extension, elbow flexion and extension, fasting insulin levels, and homeostasis model assessment of insulin resistance (HOMA-IR) levels', 'fasting insulin and HOMA-IR levels', 'average fasting insulin', 'fasting insulin and fitness levels', 'mean fasting insulin', 'muscle strength of the shoulder flexors, extensors, abductors, adductors, and elbow flexors', 'HOMA-IR']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",19.0,0.0718928,A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI.,"[{'ForeName': 'Dong-Il', 'Initials': 'DI', 'LastName': 'Kim', 'Affiliation': 'Department of Professional Therapy, Graduate School of Professional Therapy, Gachon University, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Can Ozan', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hyuna', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Sport Industry Studies, Exercise Medicine and Rehabilitation Laboratory, Yonsei University, 50 Yonsei-Ro, Seodaemun-Gu, Seoul, 120-749, Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ""Korea Disabled People's Development Institute, Seoul, Korea.""}, {'ForeName': 'Sang-Yong', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Gachon University, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Kyong-Mee', 'Initials': 'KM', 'LastName': 'Chung', 'Affiliation': 'Department of Psychology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Young-Hee', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Yonsei University Wonju College of Medicine, Wonju, Gangwon-do, Korea.'}, {'ForeName': 'Bum-Suk', 'Initials': 'BS', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Hospital, Seoul, Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Sport Industry Studies, Exercise Medicine and Rehabilitation Laboratory, Yonsei University, 50 Yonsei-Ro, Seodaemun-Gu, Seoul, 120-749, Korea. jjeon@yonsei.ac.kr.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05885-7'] 1060,31175001,"Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial.","BACKGROUND Patients with relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute myeloid leukaemia have a poor prognosis, including high frequency of relapse, poorer response to salvage therapy, and shorter overall survival than those with FLT3 wild-type disease. We aimed to assess whether single-agent quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, improves overall survival versus salvage chemotherapy. METHODS QuANTUM-R is a randomised, controlled, phase 3 trial done at 152 hospitals and cancer centres in 19 countries. Eligible patients aged 18 years or older with ECOG performance status 0-2 with relapsed or refractory (duration of first composite complete remission ≤6 months) FLT3-ITD acute myeloid leukaemia after standard therapy with or without allogeneic haemopoietic stem-cell transplantation were randomly assigned (2:1; permuted block size of 6; stratified by response to previous therapy and choice of chemotherapy via a phone-based and web-based interactive response system) to quizartinib (60 mg [30 mg lead-in] orally once daily) or investigator's choice of preselected chemotherapy: subcutaneous low-dose cytarabine (subcutaneous injection of cytarabine 20 mg twice daily on days 1-10 of 28-day cycles); intravenous infusions of mitoxantrone (8 mg/m 2 per day), etoposide (100 mg/m 2 per day), and cytarabine (1000 mg/m 2 per day on days 1-5 of up to two 28-day cycles); or intravenous granulocyte colony-stimulating factor (300 μg/m 2 per day or 5 μg/kg per day subcutaneously on days 1-5), fludarabine (intravenous infusion 30 mg/m 2 per day on days 2-6), cytarabine (intravenous infusion 2000 mg/m 2 per day on days 2-6), and idarubicin (intravenous infusion 10 mg/m 2 per day on days 2-4 in up to two 28-day cycles). Patients proceeding to haemopoietic stem-cell transplantation after quizartinib could resume quizartinib after haemopoietic stem-cell transplantation. The primary endpoint was overall survival in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02039726, and follow-up is ongoing. FINDINGS Between May 7, 2014, and Sept 13, 2017, 367 patients were enrolled, of whom 245 were randomly allocated to quizartinib and 122 to chemotherapy. Four patients in the quizartinib group and 28 in the chemotherapy group were not treated. Median follow-up was 23·5 months (IQR 15·4-32·3). Overall survival was longer for quizartinib than for chemotherapy (hazard ratio 0·76 [95% CI 0·58-0·98; p=0·02]). Median overall survival was 6·2 months (5·3-7·2) in the quizartinib group and 4·7 months (4·0-5·5) in the chemotherapy group. The most common non-haematological grade 3-5 treatment-emergent adverse events (within ≤30 days of last dose or >30 days if suspected to be a treatment-related event) for quizartinib (241 patients) and chemotherapy (94 patients) were sepsis or septic shock (46 patients [19%] for quizartinib vs 18 [19%] for chemotherapy), pneumonia (29 [12%] vs eight [9%]), and hypokalaemia (28 [12%] vs eight [9%]). The most frequent treatment-related serious adverse events were febrile neutropenia (18 patients [7%]), sepsis or septic shock (11 [5%]), QT prolongation (five [2%]), and nausea (five [2%]) in the quizartinib group, and febrile neutropenia (five [5%]), sepsis or septic shock (four [4%]), pneumonia (two [2%]), and pyrexia (two [2%]) in the chemotherapy group. Grade 3 QT prolongation in the quizartinib group was uncommon (eight [3%] by central reading, ten [4%] by investigator report); no grade 4 events occurred. There were 80 (33%) treatment-emergent deaths in the quizartinib group (31 [13%] of which were due to adverse events) and 16 (17%) in the chemotherapy group (nine [10%] of which were due to adverse events). INTERPRETATION Treatment with quizartinib had a survival benefit versus salvage chemotherapy and had a manageable safety profile in patients with rapidly proliferative disease and very poor prognosis. Quizartinib could be considered a new standard of care. Given that there are only a few available treatment options, this study highlights the value of targeting the FLT3-ITD driver mutation with a highly potent and selective FLT3 inhibitor. FUNDING Daiichi Sankyo.",2019,Overall survival was longer for quizartinib than for chemotherapy (hazard ratio 0·76 [95% CI 0·58-0·98; p=0·02]).,"['Patients proceeding to haemopoietic stem-cell transplantation after quizartinib could resume quizartinib after haemopoietic stem-cell transplantation', 'Eligible patients aged 18 years or older with ECOG performance status 0-2 with relapsed or refractory (duration of first composite complete remission ≤6 months) FLT3-ITD acute myeloid leukaemia after standard therapy with or without allogeneic haemopoietic stem-cell transplantation', 'relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R', 'Between May 7, 2014, and Sept 13, 2017, 367 patients were enrolled, of whom 245 were randomly allocated to quizartinib and 122 to chemotherapy', '152 hospitals and cancer centres in 19 countries', 'Patients with relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute myeloid leukaemia']","['cytarabine', 'mitoxantrone', 'etoposide', 'Quizartinib versus salvage chemotherapy', 'cytarabine (intravenous infusion 2000 mg/m 2 per day on days 2-6), and idarubicin', 'fludarabine', 'intravenous granulocyte colony-stimulating factor', ""chemotherapy via a phone-based and web-based interactive response system) to quizartinib (60 mg [30 mg lead-in] orally once daily) or investigator's choice of preselected chemotherapy: subcutaneous low-dose cytarabine (subcutaneous injection of cytarabine""]","['pyrexia', 'febrile neutropenia', 'treatment-emergent deaths', 'sepsis or septic shock', 'hypokalaemia', 'nausea', 'Overall survival', 'pneumonia', 'QT prolongation', 'Median overall survival', 'overall survival', 'Grade 3 QT prolongation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",367.0,0.408052,Overall survival was longer for quizartinib than for chemotherapy (hazard ratio 0·76 [95% CI 0·58-0·98; p=0·02]).,"[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: jcortes@mdanderson.org.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Khaled', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola FC, Italy.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Perl', 'Affiliation': 'Abramson Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'The University of Kansas Health System, Kansas City, KS, USA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Russell', 'Affiliation': 'Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Universität Heidelberg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': 'University Paris Diderot, Paris, France.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hogge', 'Affiliation': 'Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Jonas', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Anskar Yu-Hung', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Mehta', 'Affiliation': 'University Hospitals Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari I Politècnic La Fe, València, Spain; CIBERONC, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Radsak', 'Affiliation': 'University Medical Center of Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Sica', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli-IRCCS, Istituto di Ematologia Università Cattolica Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Arunachalam', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Holmes', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Namuyinga', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Nanxiang', 'Initials': 'N', 'LastName': 'Ge', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Yver', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Yufen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Levis', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30150-0'] 1061,31174214,Fiber Intake Predicts Weight Loss and Dietary Adherence in Adults Consuming Calorie-Restricted Diets: The POUNDS Lost (Preventing Overweight Using Novel Dietary Strategies) Study.,"BACKGROUND The effects of dietary composition on weight loss are incompletely understood. In addition to energy intake, fiber intake, energy density, macronutrient composition, and demographic characteristics have all been suggested to contribute to weight loss. OBJECTIVE The primary aim of this analysis was to assess the role of dietary fiber as a predictor of weight loss in participants who consumed calorie-restricted diets (-750 kcal/d from estimated energy needs) for 6 mo, using data from the POUNDS Lost (Preventing Overweight Using Novel Dietary Strategies) Study-a randomized trial that examined the effects of calorie-restricted diets varying in macronutrient composition on weight loss in adults. METHODS Data were randomly partitioned to a training data set (70%) in which the effects of fiber and other weight-loss predictors were identified using adjusted Least Absolute Shrinkage and Selection Operator and model averaging. The retained predictors were then fit on the testing data set to assess predictive performance. RESULTS Three hundred and forty-five participants (53.9% female) provided dietary records at baseline and 6 mo. Mean ± SD age and BMI for the full sample was 52.5 ± 8.7 y and 32.6 ± 3.9 kg/m2, respectively. Mean ± SD (99% CI) weight change at 6 mo for the full sample was -7.27 ± 5.6 kg (-8.05, -6.48 kg). The final, best fit model (R2 = 0.41) included fiber, energy density, fat, age, adherence, baseline weight, race, and changes from baseline in carbohydrate, fiber, PUFA, and MUFA intake, but the most influential predictor was fiber intake ($\hat{\beta }$ = -0.37; P < 0.0001). In addition, fiber was strongly associated with adherence to the macronutrient prescriptions (P < 0.0001). Interactions between race and adherence, age, baseline weight, carbohydrate, energy density, and MUFAs were also retained in the final model. CONCLUSION Dietary fiber intake, independently of macronutrient and caloric intake, promotes weight loss and dietary adherence in adults with overweight or obesity consuming a calorie-restricted diet. This trial was registered at clinicaltrials.gov as NCT00072995.",2019,"In addition, fiber was strongly associated with adherence to the macronutrient prescriptions (P < 0.0001).","['Adults', 'adults with overweight or obesity consuming a calorie-restricted diet', 'Three hundred and forty-five participants (53.9% female) provided dietary records at baseline and 6 mo', 'participants who consumed calorie-restricted diets (-750 kcal/d from estimated energy needs) for 6 mo, using data from the POUNDS Lost (Preventing Overweight', 'adults']","['Consuming Calorie-Restricted Diets', 'calorie-restricted diets varying in macronutrient composition']","['weight loss', 'Mean\xa0±\xa0SD age and BMI', 'fiber, energy density, fat, age, adherence, baseline weight, race, and changes from baseline in carbohydrate, fiber, PUFA, and MUFA intake', 'Mean\xa0±\xa0SD (99% CI) weight change', 'fiber intake ($\\hat{\\beta ', 'weight loss and dietary adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",345.0,0.0751273,"In addition, fiber was strongly associated with adherence to the macronutrient prescriptions (P < 0.0001).","[{'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Miketinas', 'Affiliation': ""Department of Nutrition and Food Sciences, Texas Woman's University, Houston, TX, USA.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz117'] 1062,31154664,Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation.,"OBJECTIVE We characterized lipid trajectories and investigated lipids and rate of pregnancy lipid change with the risk of pregnancy loss or preterm delivery <37 weeks. STUDY DESIGN In a secondary analysis of 337 women with one to two prior losses assigned to placebo in a randomized controlled trial at four centers (2007-2012), cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides were measured up to 6 months prepregnancy (time 0) and pregnancy up to 7 visits. Trajectories were created using linear mixed models. Multivariable logistic regression with adjustment for maternal characteristics and cholesterol was performed. RESULTS Lipids decreased from prepregnancy to 4 to 5 weeks, followed by an increase, and were biphasic or triphasic depending on the lipid component. Between 4 and 8 weeks, for every 1-unit increase in HDL-C, there was a 22% decreased odds of loss <14 weeks (odds ratio: 0.78; 95% confidence interval: 0.60, 0.99) and 24% decreased odds of loss or preterm delivery 14 to <37 weeks (odds ratio: 0.76; 95% confidence interval: 0.60, 0.96). CONCLUSION There were no associations with other lipid components or other time points. An impaired rise of HDL-C early in pregnancy may signal maladaptation to pregnancy that is associated with pregnancy loss or preterm delivery.",2020,There were no associations with other lipid components or other time points.,['337 women with one to two prior losses assigned to'],['placebo'],"['HDL-C', 'Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation', 'cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",337.0,0.217667,There were no associations with other lipid components or other time points.,"[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Grantz', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Elmi', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Pugh', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Catov', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science and Department of Epidemiology, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Albert', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}]",American journal of perinatology,['10.1055/s-0039-1689000'] 1063,29754952,"Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes.","Intermittent fasting (IF) improves cardiometabolic health; however, it is unknown whether these effects are due solely to weight loss. We conducted the first supervised controlled feeding trial to test whether IF has benefits independent of weight loss by feeding participants enough food to maintain their weight. Our proof-of-concept study also constitutes the first trial of early time-restricted feeding (eTRF), a form of IF that involves eating early in the day to be in alignment with circadian rhythms in metabolism. Men with prediabetes were randomized to eTRF (6-hr feeding period, with dinner before 3 p.m.) or a control schedule (12-hr feeding period) for 5 weeks and later crossed over to the other schedule. eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite. We demonstrate for the first time in humans that eTRF improves some aspects of cardiometabolic health and that IF's effects are not solely due to weight loss.",2018,"eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite.","['Men with prediabetes', 'Men with Prediabetes']","['eTRF', 'Intermittent fasting ']","['weight loss', 'cardiometabolic health', 'eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite', 'Insulin Sensitivity, Blood Pressure, and Oxidative Stress']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",,0.0190782,"eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite.","[{'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Sutton', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Kate S', 'Initials': 'KS', 'LastName': 'Early', 'Affiliation': 'Health, Physical Education, and Exercise Science, Columbus State University, Columbus, GA 31907, USA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Cefalu', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA; American Diabetes Association, Arlington, VA 22202, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA; Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL 35294, USA. Electronic address: cpeterso@uab.edu.'}]",Cell metabolism,['10.1016/j.cmet.2018.04.010'] 1064,31168287,Trust and Glycemic Control in Black Patients With Diabetic Retinopathy: A Pilot Study.,"Diabetic retinopathy (DR) is more prevalent in blacks than whites because, compared to whites, blacks on average have worse glycemic control. Both of these racial disparities reflect differences in sociocultural determinants of health, including physician mistrust. This randomized, controlled 6-month pilot trial compared the efficacy of a culturally tailored behavioral health/ophthalmologic intervention called Collaborative Care for Depression and Diabetic Retinopathy (CC-DDR) to enhanced usual care (EUC) for improving glycemic control in black patients with DR ( n = 33). The mean age of participants was 68 years (SD 6.1 years), 76% were women, and the mean A1C was 8.7% (SD 1.5%). At baseline, 14 participants (42%) expressed mistrust about ophthalmologic diagnoses. After 6 months, CC-DDR participants had a clinically meaningful decline in A1C of 0.6% (SD 2.1%), whereas EUC participants had an increase of 0.2% (SD 1.1%) ( f [1, 28] = 1.9; P = 0.176). Within CC-DDR, participants with trust had a reduction in A1C (1.4% [SD 2.5%]), whereas participants with mistrust had an increase in A1C (0.44% [SD 0.7%]) ( f [1, 11] = 2.11; P = 0.177). EUC participants with trust had a reduction in A1C (0.1% [SD 1.1%]), whereas those with mistrust had an increase in A1C (0.70% [SD 1.1%]) ( f [1, 16] = 2.01; P = 0.172). Mistrust adversely affected glycemic control independent of treatment. This finding, coupled with the high rate of mistrust, highlights the need to target mistrust in new interventions to improve glycemic control in black patients with DR.",2019,"EUC participants with trust had a reduction in A1C (0.1% [SD 1.1%]), whereas those with mistrust had an increase in A1C (0.70% [SD 1.1%])","['With Diabetic Retinopathy', 'Black Patients', 'black patients with DR', 'black patients with DR ( n = 33']","['enhanced usual care (EUC', 'culturally tailored behavioral health/ophthalmologic intervention called Collaborative Care']","['reduction in A1C', 'Diabetic retinopathy (DR', 'A1C']","[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0205481', 'cui_str': 'Ophth. - Ophthalmologic'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]",76.0,0.0374122,"EUC participants with trust had a reduction in A1C (0.1% [SD 1.1%]), whereas those with mistrust had an increase in A1C (0.70% [SD 1.1%])","[{'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Rovner', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Casten', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA.'}]",Diabetes spectrum : a publication of the American Diabetes Association,['10.2337/ds18-0037'] 1065,31167902,Effect of menthol cigarette and other menthol tobacco product bans on tobacco purchases in the RTI iShoppe virtual convenience store.,"OBJECTIVE To test how a potential US ban of menthol products or replacement with 'green' products and ads could influence tobacco purchases. METHODS US adult menthol smokers (N=1197) were recruited via an online panel and randomly assigned to complete a shopping task in one of four versions (experimental conditions) of the RTI iShoppe virtual store: (1) no ban, (2) replacement of menthol cigarettes and ads with green replacement versions, (3) menthol cigarette ban and (4) all menthol tobacco product ban. Logistic regressions assessed the effect of condition on tobacco purchases. RESULTS Participants in the menthol cigarette ban (OR=0.67, 95% CI 0.48 to 0.92) and all menthol product ban conditions (OR=0.60, 95% CI 0.43 to 0.83) were less likely to purchase cigarettes of any type than participants in the no ban condition. Participants in the green replacement (OR=1.74, 95% CI 1.13 to 2.70), menthol cigarette ban (OR=3.40, 95% CI 2.14 to 5.41) and all menthol product ban conditions (OR=3.14, 95% CI 1.97 to 5.01) were more likely to purchase a cigarette brand different from their usual brand than participants in the no ban condition. CONCLUSIONS Our findings suggest that menthol bans could have great public health impact by reducing cigarette purchases. However, tobacco marketing strategies, such as creating green (or other replacement) versions of menthol cigarettes, may undermine public health benefits of a menthol ban by prompting purchases of non-menthol cigarettes. Our findings highlight the importance of taking tobacco marketing tactics into consideration in tobacco product regulation.",2020,"Participants in the green replacement (OR=1.74, 95% CI 1.13 to 2.70), menthol cigarette ban (OR=3.40, 95% CI 2.14 to 5.41) and all menthol product ban conditions (OR=3.14, 95% CI 1.97 to 5.01) were more likely to purchase a cigarette brand different from their usual brand than participants in the no ban condition. ","['US adult menthol smokers (N=1197', 'tobacco purchases in the RTI iShoppe virtual convenience store']","['shopping task in one of four versions (experimental conditions) of the RTI iShoppe virtual store: (1) no ban, (2) replacement of menthol cigarettes and ads with green replacement versions, (3) menthol cigarette ban and (4) all menthol tobacco product ban', 'menthol cigarette and other menthol tobacco product']",['menthol cigarette'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}]","[{'cui': 'C0150768', 'cui_str': 'Shopping (observable entity)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0105185', 'cui_str': 'BANS'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",1197.0,0.0670835,"Participants in the green replacement (OR=1.74, 95% CI 1.13 to 2.70), menthol cigarette ban (OR=3.40, 95% CI 2.14 to 5.41) and all menthol product ban conditions (OR=3.14, 95% CI 1.97 to 5.01) were more likely to purchase a cigarette brand different from their usual brand than participants in the no ban condition. ","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Guillory', 'Affiliation': 'Prime Affect Research, Dublin, Ireland jamieguillory.contractor@rti.org.'}, {'ForeName': 'Annice E', 'Initials': 'AE', 'LastName': 'Kim', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bradfield', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Nathaniel Harlan', 'Initials': 'NH', 'LastName': 'Taylor', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Dutra', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Feld', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-054997'] 1066,31867987,Individual and organizational characteristics predicting intervention use for children with autism in schools.,"LAY ABSTRACT Several interventions or treatment programs have been shown through research to improve social outcomes for children with autism, but they often are not used in schools. This study examined individual (school personnel) and organizational (school level) factors associated with the use of a research-informed social engagement intervention, Remaking Recess, for children with autism in elementary schools. A total of 28 school personnel from 12 schools in 5 districts in the northeastern United States participated. Schools were randomly assigned to (1) training in Remaking Recess only or (2) training in Remaking Recess with implementation support (tailored strategies to remove barriers to increase use of Remaking Recess). School personnel rated their attitudes about research-informed interventions, organizational readiness (school's readiness to use a research-informed intervention), and fidelity or the degree to which an intervention is used as it was originally designed. Observers rated school personnel's fidelity at baseline (pre-intervention training) and exit (post-intervention training). The results suggest that self-rated fidelity was lower when staff perceived the use of Remaking Recess was required; however, observer-rated fidelity was lower when staff rated Remaking Recess as appealing. In addition, self-rated fidelity was higher when there was a sufficient number of staff, positive individual growth, and organizational adaptability. The results also indicated higher observer-rated fidelity when staff perceived positive influence over their coworkers. The results suggest that both individual (attitudes) and organizational (influence, staffing, growth, adaptability) characteristics may affect implementation success in schools. A collaborative decision-making approach for evidence-based practice use is recommended.",2020,Observers rated school personnel's fidelity at baseline (pre-intervention training) and exit (post-intervention training).,"['children with autism', 'children with autism in elementary schools', '28 school personnel from 12 schools in 5 districts in the northeastern United States participated', 'children with autism in schools']",['training in Remaking Recess only or (2) training in Remaking Recess with implementation support (tailored strategies to remove barriers to increase use of Remaking Recess'],"['self-rated fidelity', ""Observers rated school personnel's fidelity""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036375', 'cui_str': 'School'}]",,0.0181544,Observers rated school personnel's fidelity at baseline (pre-intervention training) and exit (post-intervention training).,"[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Locke', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kang-Yi', 'Affiliation': 'University of Pennsylvania, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Frederick', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Mandell', 'Affiliation': 'University of Pennsylvania, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361319895923'] 1067,31152080,"Phase II, Multicenter, Randomized Trial of Docetaxel plus Prednisone with or Without Cediranib in Men with Chemotherapy-Naive Metastatic Castrate-Resistant Prostate Cancer.","LESSONS LEARNED The negative results are consistent with the negative results of large phase III trials in which docetaxel plus antiangiogenic agents were used in patients with metastatic castrate-resistant prostate cancer (mCRPC).The negative data underscore that, despite a sound biological rationale and supportive early-phase clinical results, adding antiangiogenic agents to docetaxel for mCRPC is a great challenge. BACKGROUND Inhibition of vascular endothelial growth factor (VEGF) signaling abrogates tumor-induced angiogenesis to constrain tumor growth, and can be exploited therapeutically by using cediranib, an oral tyrosine kinase inhibitor of VEGF receptor signaling. Our preliminary phase I trial data showed that adding cediranib to docetaxel plus prednisone (DP) was safe and feasible, with early evidence for efficacy in patients with metastatic castrate-resistant prostate cancer (mCRPC). METHODS This multicenter phase II trial assessed whether adding cediranib to DP improves efficacy of DP in patients with mCRPC. Chemotherapy-naive patients with mCRPC were randomly assigned to receive either docetaxel (75 mg/m 2 intravenously every 3 weeks) with prednisone (5 mg twice daily) plus cediranib (30 mg once daily; the DP+C arm) or DP only (the DP arm). The primary endpoint was to compare 6-month progression-free survival (PFS) rate between the two arms. Secondary endpoints included 6-month overall survival (OS), objective tumor and prostate-specific antigen (PSA) response rates, biomarkers, and adverse events. RESULTS The 6-month PFS rate in a total of 58 patients was only numerically higher in the DP+C arm (61%) compared with the DP arm (57%). Similarly, the 6-month OS rate, objective tumor and PSA response rates, and biomarkers were not significantly different between the two arms. Increased baseline levels of interleukin 6 (IL-6), however, were significantly associated with increased risk of progression. Neutropenia was the only grade 4 toxicity (38% in the DP+C arm vs. 18% in the DP arm). CONCLUSION Combining cediranib with docetaxel + prednisone failed to demonstrate superior efficacy, compared with docetaxel + prednisone, and added toxicity. Our data do not support pursuing the combination further in patients with mCRPC.",2019,"Similarly, the 6-month OS rate, objective tumor and PSA response rates, and biomarkers were not significantly different between the two arms.","['patients with metastatic castrate-resistant prostate cancer (mCRPC', 'naive patients with mCRPC', 'patients with mCRPC', 'patients with metastatic castrate-resistant prostate cancer', 'Men with Chemotherapy-Naive Metastatic Castrate-Resistant Prostate Cancer']","['Chemotherapy', 'Docetaxel plus Prednisone with or Without Cediranib', 'cediranib', 'docetaxel', 'cediranib to DP', 'prednisone', 'cediranib to docetaxel plus prednisone (DP', 'docetaxel + prednisone', 'docetaxel plus antiangiogenic agents']","['6-month overall survival (OS), objective tumor and prostate-specific antigen (PSA) response rates, biomarkers, and adverse events', '6-month OS rate, objective tumor and PSA response rates, and biomarkers', 'risk of progression', '6-month PFS rate', 'toxicity', 'Neutropenia', '6-month progression-free survival (PFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}, {'cui': 'C0596087', 'cui_str': 'Inhibitors, Angiogenetic'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",58.0,0.0616348,"Similarly, the 6-month OS rate, objective tumor and PSA response rates, and biomarkers were not significantly different between the two arms.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Heath', 'Affiliation': 'Department of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA heathe@karmanos.org.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Heilbrun', 'Affiliation': 'Department of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Mannuel', 'Affiliation': 'Division of Hematology/Oncology, University of Maryland School of Medicine and Greenebaum Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Division of Hematology/Oncology, University of Wisconsin School of Medicine and Public Health and Carbone Cancer Center, Madison, Wisconsin, USA.'}, {'ForeName': 'Primo', 'Initials': 'P', 'LastName': 'Lara', 'Affiliation': 'Division of Hematology/Oncology, University of California Davis School of Medicine and Cancer Center, Sacramento, California, USA.'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Monk', 'Affiliation': 'Division of Medical Oncology, Ohio State University School of Medicine and Cancer Center - James, Columbus, Ohio, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Flaig', 'Affiliation': 'Division of Medical Oncology, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Zurita', 'Affiliation': 'Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mack', 'Affiliation': 'Division of Hematology/Oncology, University of California Davis School of Medicine and Cancer Center, Sacramento, California, USA.'}, {'ForeName': 'Ulka', 'Initials': 'U', 'LastName': 'Vaishampayan', 'Affiliation': 'Department of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Stella', 'Affiliation': 'IHA Hematology/Oncology, Ypsilanti, Michigan, USA.'}, {'ForeName': 'Daryn', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bolton', 'Affiliation': 'Department of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Division of Hematology/Oncology, University of Maryland School of Medicine and Greenebaum Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Al-Janadi', 'Affiliation': 'Michigan State University Breslin Cancer Center, Lansing, Michigan, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silbiger', 'Affiliation': 'Case Western Reserve University School of Medicine University Hospitals, Cleveland, Ohio, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Usman', 'Affiliation': 'Department of Oncology, Wayne State University School of Medicine and Karmanos Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'S Percy', 'Initials': 'SP', 'LastName': 'Ivy', 'Affiliation': 'National Institutes of Health National Cancer Institute, Bethesda, Maryland, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0331'] 1068,26416127,Mammography Adherence in African-American Women: Results of a Randomized Controlled Trial.,"BACKGROUND Breast cancer is the second leading cause of cancer mortality among women in the developed world. Mammography screening is especially important for African-Americans because they experience a greater mortality (OR = 1.38) than Caucasians despite having a lower incidence of breast cancer. PURPOSE The purpose of this study was to compare the effects of two interventions with usual care on mammography adherence among African-American women. METHODS A subsample of African-American women (n = 244) aged 41-65 years who had not had a mammogram in the last 15 months and no history of breast cancer was randomly assigned to receive (1) mailed interactive DVD, (2) computer-tailored telephone counseling, or (3) usual care. RESULTS The DVD intervention was five times more effective than usual care for promoting mammography screening at 6 months follow-up among women who earned less than $30,000 (OR = 5.3). Compared to usual care, neither the DVD nor phone produced significant effects for women with household incomes >$30,000. CONCLUSION Use of a mailed DVD for low-income African-American women may be an effective way to increase mammography adherence.",2016,"Compared to usual care, neither the DVD nor phone produced significant effects for women with household incomes >$30,000. ","['low-income African-American women', 'African-American Women', 'African-Americans', 'African-American women', 'women in the developed world', 'women with household incomes >$30,000', 'A subsample of African-American women (n\u2009=\u2009244) aged 41-65 years who had not had a mammogram in the last 15 months and no history of breast cancer']","['mailed interactive DVD, (2) computer-tailored telephone counseling, or (3) usual care', 'Mammography screening', 'usual care']","['mammography adherence', 'Mammography Adherence']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557163', 'cui_str': 'Household income (observable entity)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}]",,0.0308438,"Compared to usual care, neither the DVD nor phone produced significant effects for women with household incomes >$30,000. ","[{'ForeName': 'Wambui G', 'Initials': 'WG', 'LastName': 'Gathirua-Mwangi', 'Affiliation': 'Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, 714 N Senate Avenue, Suite EF 209, Indianapolis, IN, 46202, USA. ggathiru@iupui.edu.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, 714 N Senate Avenue, Suite EF 209, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Stump', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'University of Texas Southwestern Harold C Simmons Cancer Center, Dallas, TX, USA.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-015-9733-0'] 1069,31569012,High-intensity interval training modulates male factor infertility through anti-inflammatory and antioxidative mechanisms in infertile men: A randomized controlled trial.,"The effects of 24 weeks of high-intensity interval training (HIIT) on markers of male reproductive function in infertile patients were studied. Infertile men (n = 441) were randomized to exercise (EX, n = 221) or non-exercise (NON-EX, n = 220) group. Patients in the EX group performed an interval training (1:1 work:rest ratio) 3 times per week at 75-95% of maximal oxygen consumption, for 24 weeks (VO 2max ). Markers of inflammation and oxidative stress in the seminal plasma, as well as semen parameters, sperm DNA fragmentation and rates of pregnancy, were measured at baseline, on weeks 12, 24; and 7 and 30 days thereafter during the recovery period. The intervention resulted in decreased seminal levels of proinflammatory cytokines (IL-1β, IL-6, IL-8, and TNF-α) and markers of oxidative stress (ROS, MDA, and 8-isoprostane) (P < 0.05). The concentrations of seminal antioxidants were unaltered with HIIT intervention. These changes further coincide with promising developments in semen parameters, sperm DNA integrity and rates of pregnancy (P < 0.05). This may indicate that HIIT induced beneficial effects on markers of male reproductive function through decreased oxidative damage and proinflammatory status. Findings highlight the possibility that HIIT may be an effective intervention for male factor infertility and support the need for further human studies.",2020,"The intervention resulted in decreased seminal levels of proinflammatory cytokines (IL-1β, IL-6, IL-8, and TNF-α) and markers of oxidative stress (ROS, MDA, and 8-isoprostane) (P < 0.05).","['infertile patients', 'Infertile men (n\u202f=\u202f441', 'infertile men', 'male factor infertility']","['exercise (EX, n\u202f=\u202f221) or non-exercise (NON-EX, n\u202f=\u202f220) group', 'interval training', 'high-intensity interval training (HIIT', 'High-intensity interval training']","['Markers of inflammation and oxidative stress', 'concentrations of seminal antioxidants', 'semen parameters, sperm DNA integrity and rates of pregnancy', 'seminal levels of proinflammatory cytokines (IL-1β, IL-6, IL-8, and TNF-α) and markers of oxidative stress (ROS, MDA, and 8-isoprostane']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}]",441.0,0.163522,"The intervention resulted in decreased seminal levels of proinflammatory cytokines (IL-1β, IL-6, IL-8, and TNF-α) and markers of oxidative stress (ROS, MDA, and 8-isoprostane) (P < 0.05).","[{'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Hajizadeh Maleki', 'Affiliation': 'Department of Sports Medicine, Justus-Liebig-University, Giessen, Germany. Electronic address: behzad.hajizadeh-maleki@sport.uni-giessen.de.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Department of Sports Injuries, Faculty of Physical Education and Sports Sciences, Allameh Tabataba'i University, Tehran, Iran.""}]",Cytokine,['10.1016/j.cyto.2019.154861'] 1070,31155223,An online healthy relationship tool and safety decision aid for women experiencing intimate partner violence (I-DECIDE): a randomised controlled trial.,"BACKGROUND Evidence for online interventions to help women experiencing intimate partner violence is scarce. We assessed whether an online interactive healthy relationship tool and safety decision aid (I-DECIDE) would increase women's self-efficacy and improve depressive symptoms compared with an intimate partner violence information website. METHODS In this two-group pragmatic randomised controlled trial, we enrolled women who had screened positive for any form of intimate partner violence or fear of a partner in the 6 months before recruitment. Women aged 16-50 years currently residing in Australia, who had safe access to a computer and an internet connection, and who answered positively to one of the screening questions in English were eligible for inclusion. Participants were randomly assigned (1:1) by computer to receive either the intervention or control website. The intervention website consisted of modules on healthy relationships, abuse and safety, and relationship priority setting, and a tailored action plan. The control website was a static intimate partner violence information website. As the initial portion of the website containing the baseline questions was identical for both groups, there was no way for women to tell which group they had been allocated to, and the research team were also masked to participant allocation until after analysis of the 12-month data. Data were collected at baseline, immediately after completion of the website, at 6 months, and 12 months. Primary outcomes were mean general self-efficacy score (immediately after website completion, and at 6 months and 12 months) and mean depression score (at 6 months and 12 months). Data analyses were done according to intention-to-treat principles, accounting for missing data, and adjusted for outcome baseline scores. This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN 12614001306606. FINDINGS Between Jan 16, and Aug 28, 2015, 584 patients registered for the study and were assessed for eligibility. 422 eligible participants were randomly allocated to the intervention group (227 patients) or control group (195 patients). 179 (79%) participants in the intervention group and 156 (80%) participants in the control group completed 12-month follow-up. Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3 [95% CI 0·3 to 2·3]; 12 months: 27·8 [SD 5·4] vs 29·0 [5·0], imputed mean difference 1·6 [95% CI 0·5 to 2·7]). We found no difference between groups in depressive symptoms at 6 months or 12 months (6 months: 22·5 [SD 17·1] vs 24·2 [17·2], imputed mean difference -0·3 [95% CI -3·5 to 3·0]; 12 months: 21·9 [SD 19·3] vs 21·5 [19·3], imputed mean difference -1·9 [95% CI -5·6 to 1·7]). Qualitative findings indicated that participants found the intervention supportive and a motivation for action. INTERPRETATION Our findings highlight the need for further research, development, and refinement of online interventions for women experiencing intimate partner violence, particularly into the duration needed for interventions. Although we detected no meaningful differences between groups, our qualitative results indicated that some women find an online tool a helpful source of motivation and support. FUNDING Australian Research Council.",2019,"Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3","['1·6', 'Women aged 16-50 years currently residing in Australia, who had safe access to a computer and an internet connection, and who answered positively to one of the screening questions in English were eligible for inclusion', 'women experiencing intimate partner violence', 'enrolled women who had screened positive for any form of intimate partner violence or fear of a partner in the 6 months before recruitment', '422 eligible participants', 'women experiencing intimate partner violence (I-DECIDE', 'Between Jan 16, and Aug 28, 2015, 584 patients registered for the study and were assessed for eligibility']",['intervention or control website'],"['mean depression score', 'Mean self-efficacy', 'depressive symptoms', 'mean general self-efficacy score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",422.0,0.227019,"Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3","[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hegarty', 'Affiliation': ""Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia; The Royal Women's Hospital, Melbourne, VIC, Australia. Electronic address: k.hegarty@unimelb.edu.au.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tarzia', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Valpied', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'eHealth Unit, Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Novy', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'Department of Population Health, Deakin University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}]",The Lancet. Public health,['10.1016/S2468-2667(19)30079-9'] 1071,31756536,Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplant for Patients with Multiple Myeloma: Long-Term Follow-Up Results from the Blood and Marrow Transplant Clinical Trials Network 0102 Trial.,"Allogeneic hematopoietic cell transplant (HCT) may improve long-term multiple myeloma (MM) control through the graft-versus-myeloma effect. The Blood and Marrow Transplant Clinical Trials Network 0102 trial was a biologic assignment trial comparing tandem autologous transplant (auto-auto) versus autologous followed by reduced-intensity allogeneic (auto-allo) transplant in patients with newly diagnosed MM with standard-risk (n = 625) or high-risk (n = 85; β 2 -microglobulin at diagnosis ≥ 4 mg/dL or deletion of chromosome 13 by conventional karyotyping) disease. Although the initial 3-year analysis showed no difference in progression-free survival (PFS) between arms in either risk group, we hypothesized that long-term follow-up may better capture the impact of the graft-versus-myeloma effect. Median follow-up of survivors was over 10 years. Among standard-risk patients there was no difference in PFS (hazard ratio [HR], 1.11; 95% confidence interval [CI], .93 to 1.35; P = .25) or OS (HR, 1.03; 95% CI, .82 to 1.28; P = .82). The 6-year PFS was 25% in the auto-auto arm versus 22% in the auto-allo arm (P = .32), and 6-year overall survival (OS) was 60% and 59%, respectively (P = .85). In the high-risk group, although there was no statistically significant difference in PFS (HR, .66; 95% CI, .41 to 1.07; P = .07) and OS (HR, 1.01; 95% CI, .60 to 1.71; P = .96), a reduction in 6-year risk of relapse of 77% versus 47% (P = .005) was reflected in better PFS of 13% versus 31% (P = .05) but similar OS, at 47% versus 51% (P = .69). Allogeneic HCT can lead to long-term disease control in patients with high-risk MM and needs to be explored in the context of modern therapy.",2020,"Among standard risk patients there was no difference in PFS (HR 1.11, 95% C.I. 0.93- 1.35, P=0.25) or OS (HR 1.03, 95% C.I. 0.82-1.28, P=0.82).","['Patients with Multiple Myeloma', 'patients with high risk MM', 'patients with newly diagnosed MM with standard (N=625) or high-risk (beta 2 microglobulin at diagnosis ≥ 4 mg/dl or deletion of chromosome 13 by conventional karyotyping) disease (N=85']","['Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplantation', 'tandem autologous transplant (auto-auto) vs. autologous followed by reduced intensity allogeneic (auto-allo) transplantation', 'Allogeneic HCT', 'Allogeneic hematopoietic cell transplantation (HCT']","['6-year PFS', 'progression-free survival (PFS', '6-year risk of relapse', '6-year overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0008655', 'cui_str': 'Chromosome 13'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0022526', 'cui_str': 'Karyotype Analysis Methods'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",625.0,0.209154,"Among standard risk patients there was no difference in PFS (HR 1.11, 95% C.I. 0.93- 1.35, P=0.25) or OS (HR 1.03, 95% C.I. 0.82-1.28, P=0.82).","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: GiraltS@mskcc.org.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maloney', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Fei', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Division of Hematologic Malignancies, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Brunstein', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'National Institutes of Health-National Heart, Lung, and Blood Institute Government Agency Partners, Bethesda, Maryland.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'VA Tennessee Valley HCS HSCT Program Nashville, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Logan', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin; Division of Biostatistics, Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lowsky', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University Medical, Stanford, California.'}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Sahebi', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Somlo', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey; Lombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Vogl', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Vesole', 'Affiliation': 'John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Pasquini', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Stadtmauer', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.11.018'] 1072,31166248,A RANDOMIZED PAIRED-EYE TRIAL OF INTRAVITREAL DEXAMETHASONE IMPLANT FOR CYSTOID MACULAR EDEMA IN RETINITIS PIGMENTOSA.,"PURPOSE To evaluate the efficacy and safety of intravitreal dexamethasone (DEX) implant in retinitis pigmentosa patients with cystoid macular edema (CME). METHODS In this randomized, noncontrolled, paired-eye, single crossover clinical trial, one eye of retinitis pigmentosa patients with bilateral CME with central macular thickness of >250 µm was randomized to intravitreal DEX implant while the fellow eye was observed. Both eyes were started on topical dorzolamide. At Month 6, DEX implant was eligible for both eyes when CME was >250 µm. Patients were followed up until Month 12. Primary outcome measures were the central macular thickness and best-corrected visual acuity changes from baseline at Month 2. RESULTS Fourteen patients with bilateral RP-CME were included. Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6. Intravitreal DEX implant at Month 6 produced comparable efficacy to baseline treatment in 11 fellow eyes and 12 study eyes. Topical dorzolamide did not show significant therapeutic efficacy. During 12 months, elevated intraocular pressure of >21 mmHg and cataract progression were observed in 14.3% and 40.0% of study eyes. CONCLUSION Intravitreal DEX implant can both reduce macular thickness and improve vision in RP-CME, while repeated injection is required.",2020,"Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6.","['11 fellow eyes and 12 study eyes', 'retinitis pigmentosa patients with cystoid macular edema (CME', 'retinitis pigmentosa patients with bilateral CME with central macular thickness of >250 µm', 'Fourteen patients with bilateral RP-CME']","['Intravitreal DEX', 'DEX', 'intravitreal dexamethasone (DEX) implant', 'intravitreal DEX', 'topical dorzolamide', 'Topical dorzolamide']","['macular thickness', 'central macular thickness and best-corrected visual acuity changes', 'central macular thickness decrease', 'best-corrected visual acuity improvement', 'therapeutic efficacy', 'efficacy and safety', 'elevated intraocular pressure of >21 mmHg and cataract progression']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0165590', 'cui_str': 'dorzolamide'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",14.0,0.0728424,"Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6.","[{'ForeName': 'Un Chul', 'Initials': 'UC', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Dae Joong', 'Initials': 'DJ', 'LastName': 'Ma', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'In Hwan', 'Initials': 'IH', 'LastName': 'Cho', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Baek-Lok', 'Initials': 'BL', 'LastName': 'Oh', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Hyeong Gon', 'Initials': 'HG', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002589'] 1073,31751805,Phase II study of S-1 in patients with previously-treated invasive thymoma and thymic carcinoma: North Japan lung cancer study group trial 1203.,"OBJECTIVES Invasive thymoma (IT) and thymic carcinoma (TC) are rare epithelial neoplasms arising in the anterior mediastinum. Platinum-based chemotherapies are widely used for first-line treatment of unresectable IT and TC, but no standard treatment has been established for previously-treated IT and TC thus far. Because promising efficacy of S-1 (tegafur, gimeracil and oteracil combination) has been reported in some retrospective studies, we conducted the first prospective phase II trial to evaluate its efficacy in previously-treated patients with advanced IT and TC. MATERIALS AND METHODS Patients progressing after at least one regimen of systemic chemotherapy received S-1 orally at a dose based on body surface area for 2 weeks followed by one week of rest until tumor progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity profile. We defined an ORR of 25% as indicating potential usefulness while ORR of 10% was the lower limit of interest. RESULTS Forty patients were enrolled (IT, n = 20; TC, n = 20). ORR was 17.5% (95% CI 7.3-32.8; IT, 10%; TC, 25%), disease control rate was 85% (IT, 95%; TC, 75%). Median PFS was 7.0 months (IT, 11.3 months; TC, 5.4 months), and median OS was 40.3 months (IT, 58.5 months; TC, 22.7 months) with a median follow-up of 51.9 months. Major toxicities (grade 3-4) were anorexia (10%), neutropenia (7.5%) and pneumonitis (5%). No treatment-related death was observed. CONCLUSION Although the primary endpoint was not met, S-1 monotherapy did have effects similar to recently reported immunotherapies for TC but at much lower cost. S-1 could represent a treatment option for previously-treated advanced TC. This trial was registered as UMIN 000008174.",2020,"Although the primary endpoint was not met, S-1 monotherapy did have effects similar to recently reported immunotherapies for TC but at much lower cost. S-1 could represent a treatment option for previously-treated advanced TC.","['Forty patients were enrolled (IT, n\u2009=\u200920; TC, n\u2009=\u200920', 'previously-treated patients with advanced IT and TC', 'Patients progressing after at least one regimen of', 'patients with previously-treated invasive thymoma and thymic carcinoma']","['S-1 (tegafur, gimeracil and oteracil combination', 'systemic chemotherapy received S-1 orally', 'S-1', 'Platinum-based chemotherapies']","['ORR', 'death', 'median OS', 'disease control rate', 'neutropenia', 'overall response rate (ORR) and secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity profile', 'Median PFS', 'anorexia', 'Major toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0040100', 'cui_str': 'Thymoma'}, {'cui': 'C0205969', 'cui_str': 'Thymic Carcinoma'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'gimeracil'}, {'cui': 'C0030032', 'cui_str': 'Oteracil'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",40.0,0.0317067,"Although the primary endpoint was not met, S-1 monotherapy did have effects similar to recently reported immunotherapies for TC but at much lower cost. S-1 could represent a treatment option for previously-treated advanced TC.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tsukita', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, 980 8574, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Palliative Medicine, Tohoku University School of Medicine, Sendai, 980 8575, Japan. Electronic address: akira.inoue.b2@tohoku.ac.jp.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, 980 0873, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Kuyama', 'Affiliation': 'Department of Respiratory Medicine, Iwakuni Clinical Center, Iwakuni, 740 8510, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Thoracic Surgery, Omagari Kosei Medical Center, Daisen, 014 0027, Japan.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Harada', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, 791 0280, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, 036 8562, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, 981 1293, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Division of Respiratory medicine, Iwate Prefectural Central Hospital, Morioka, 020 0066, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, 062 8618, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Hino', 'Affiliation': 'Department of Respiratory Medicine, Yamagata Prefectural Central Hospital, Yamagata, 990 2292, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Fujii', 'Affiliation': 'Department of Respiratory Medicine, Kobe Red Cross Hospital, Kobe, 651 0073, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Ichinose', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, 980 8574, Japan.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.10.016'] 1074,31130504,Randomized open-label trial comparing topical prescription triamcinolone to over-the-counter hydrocortisone for the treatment of phimosis.,"BACKGROUND Phimosis is a common condition affecting most infant boys and generally resolves over time without symptoms. Severe cases of phimosis can lead to balanoposthitis, urinary tract infections, and urinary retention. Medical treatment for symptomatic phimosis includes topical corticosteroids with manual foreskin retraction. OBJECTIVE Over-the-counter hydrocortisone 1% cream was compared in a randomized controlled fashion with prescription triamcinolone 0.1% cream for the medical management of symptomatic phimosis. METHODS The study institution conducted a randomized open-label trial for the treatment of grades 4-5 phimosis (phimosis grade scale 0-5). Boys aged 3-13 years were randomized to hydrocortisone 1% cream or triamcinolone 0.1% cream dosed at least twice daily for a course of 12 weeks. Instructions were provided for appropriate application and manual retraction of the foreskin. Evaluations were performed at 4, 8, and 12 weeks. Successful completion of the study was determined by reaching phimosis grade 2 or less or after completing 12 weeks of treatment. RESULTS A total of 52 boys enrolled in the trial, with a total of 32 boys completing the 12-week duration. Of the 13 boys in the hydrocortisone arm, there was a 30.8% success rate at 4 weeks, 53.8% success rate at 8 weeks, and 61.5% success rate at 12 weeks. Of the 19 boys in the triamcinolone arm, there was a 31.6% success rate at 4 weeks, 52.6% success rate at 8 weeks, and 68.4% success rate at 12 weeks. There was no statistical difference between the two arms at each interval. DISCUSSION To the study authors' knowledge, this is the first open-label trial with direct comparison of hydrocortisone 1% cream with triamcinolone 0.1% cream. The study results support those reported in other studies when each topical steroid was compared with placebo. Limitations of the study include loss to follow-up, unblinded treatment allocation, and reduced power to detect differences by treatment frequency and duration. CONCLUSION Over-the-counter hydrocortisone 1% cream is not inferior to triamcinolone 0.1% cream when paired with manual retraction for the treatment of grade 4-5 phimosis. Successful treatment response may be seen up to 12 weeks.",2019,"There was no statistical difference between the two arms at each interval. ","['grades 4-5 phimosis (phimosis grade scale 0-5', 'Boys aged 3-13 years', 'phimosis', 'A total of 52 boys enrolled in the trial, with a total of 32 boys completing the 12-week duration']","['placebo', 'triamcinolone 0.1% cream', 'topical prescription triamcinolone', 'hydrocortisone', 'triamcinolone', 'hydrocortisone 1% cream or triamcinolone 0.1% cream']","['balanoposthitis, urinary tract infections, and urinary retention', 'success rate']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0031538', 'cui_str': 'Phimosis'}, {'cui': 'C0222045'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0004691', 'cui_str': 'Balanoposthitis (disorder)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}]",52.0,0.0377056,"There was no statistical difference between the two arms at each interval. ","[{'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Chamberlin', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dorgalli', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abdelhalim', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA; Mansoura Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.""}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Davis-Dao', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Chalmers', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kelly', 'Affiliation': 'Department of Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Z T', 'Initials': 'ZT', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Division of Urology, Western University, London, ON, Canada.'}, {'ForeName': 'K-W', 'Initials': 'KW', 'LastName': 'Chuang', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'McAleer', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Stephany', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Wehbi', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Khoury', 'Affiliation': ""Department of Urology, University of California, Irvine, CA, USA; CHOC Children's Hospital of Orange County, Orange, CA, USA. Electronic address: aekhoury@uci.edu.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.04.021'] 1075,30497999,To Prompt or Not to Prompt? A Microrandomized Trial of Time-Varying Push Notifications to Increase Proximal Engagement With a Mobile Health App.,"BACKGROUND Mobile health (mHealth) apps provide an opportunity for easy, just-in-time access to health promotion and self-management support. However, poor user engagement with these apps remains a significant unresolved challenge. OBJECTIVE This study aimed to assess the effect of sending versus not sending a push notification containing a contextually tailored health message on proximal engagement, measured here as self-monitoring via the app. Secondary aims were to examine whether this effect varies by the number of weeks enrolled in the program or by weekday versus weekend. An exploratory aim was to describe how the effect on proximal engagement differs between weekday versus weekend by the time of day. METHODS The study analyzes the causal effects of push notifications on proximal engagement in 1255 users of a commercial workplace well-being intervention app over 89 days. The app employs a microrandomized trial (MRT) design to send push notifications. At 1 of 6 times per day (8:30 am, 12:30 pm, 5:30 pm, 6:30 pm, 7:30 pm, and 8:30 pm; selected randomly), available users were randomized with equal probability to be sent or not sent a push notification containing a tailored health message. The primary outcome of interest was whether the user self-monitored behaviors and feelings at some time during the next 24 hours via the app. A generalization of log-linear regression analysis, adapted for use with data arising from an MRT, was used to examine the effect of sending a push notification versus not sending a push notification on the probability of engagement over the next 24 hours. RESULTS Users were estimated to be 3.9% more likely to engage with the app in the next 24 hours when a tailored health message was sent versus when it was not sent (risk ratio 1.039; 95% CI 1.01 to 1.08; P<.05). The effect of sending the message attenuated over the course of the study, but this effect was not statistically significant (P=.84). The effect of sending the message was greater on weekends than on weekdays, but the difference between these effects was not statistically significant (P=.18). When sent a tailored health message on weekends, the users were 8.7% more likely to engage with the app (95% CI 1.01 to 1.17), whereas on weekdays, the users were 2.5% more likely to engage with the app (95% CI 0.98 to 1.07). The effect of sending a tailored health message was greatest at 12:30 pm on weekends, when the users were 11.8% more likely to engage (90% CI 1.02 to 1.13). CONCLUSIONS Sending a push notification containing a tailored health message was associated with greater engagement in an mHealth app. Results suggested that users are more likely to engage with the app within 24 hours when push notifications are sent at mid-day on weekends.",2018,"The effect of sending the message attenuated over the course of the study, but this effect was not statistically significant (P=.84).",['1255 users of a commercial workplace well-being intervention app over 89 days'],"['equal probability to be sent or not sent a push notification containing a tailored health message', 'sending versus not sending a push notification containing a contextually tailored health message']",['user self-monitored behaviors and feelings at some time during the next 24 hours via the app'],"[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]",,0.0685337,"The effect of sending the message attenuated over the course of the study, but this effect was not statistically significant (P=.84).","[{'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Bidargaddi', 'Affiliation': 'Personal Health Informatics, College of Medicine & Public Health, Adelaide, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Insitute for Social Research, Michigan University, Ann Arbor, MI, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Department of Statistics, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Insitute for Social Research, Michigan University, Ann Arbor, MI, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kovalcik', 'Affiliation': 'Insitute for Social Research, Michigan University, Ann Arbor, MI, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pituch', 'Affiliation': 'Jool Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Maaieh', 'Affiliation': 'Jool Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Strecher', 'Affiliation': 'Jool Health, Ann Arbor, MI, United States.'}]",JMIR mHealth and uHealth,['10.2196/10123'] 1076,31728860,Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC.,"Atezolizumab (Tecentriq ® ), a humanized, anti-programmed cell death ligand-1 (PD-L1) monoclonal antibody, in combination with bevacizumab, carboplatin and paclitaxel (ABCP) or with carboplatin and nab-paclitaxel (ACnP) has been approved as first-line treatment for metastatic nonsquamous NSCLC, based on results from the randomized IMpower150 and IMpower130 studies in chemotherapy-naïve patients with nonsquamous metastatic NSCLC. In IMpower150, ABCP prolonged progression-free survival (PFS) and overall survival (OS) relative to BCP, regardless of EGFR or ALK status, liver metastases at baseline or PD-L1 expression levels. In IMpower130, ACnP prolonged PFS and OS relative to CnP in patients without EGFR or ALK genetic aberrations. ABCP and ACnP had manageable tolerability profiles, which were consistent with the profile of the individual components of the regimen. Immune-related adverse events with ABCP and ACnP were largely mild or moderate in severity, and most were reversible with interruption of atezolizumab and initiation of appropriate treatment. Current evidence indicates that ABCP and ACnP are valuable emerging first-line treatment options for metastatic nonsquamous NSCLC.",2019,"In IMpower130, ACnP prolonged PFS and OS relative to CnP in patients without EGFR or ALK genetic aberrations.","['chemotherapy-naïve patients with nonsquamous metastatic NSCLC', 'Metastatic Nonsquamous NSCLC']","['Atezolizumab First-Line Combination Therapy', 'bevacizumab, carboplatin and paclitaxel (ABCP) or with carboplatin and nab-paclitaxel (ACnP', 'Atezolizumab (Tecentriq ® ', 'ABCP and ACnP']","['IMpower150, ABCP prolonged progression-free survival (PFS) and overall survival (OS) relative to BCP, regardless of EGFR or ALK status, liver metastases at baseline or PD-L1 expression levels', 'manageable tolerability profiles']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C4238884', 'cui_str': 'Tecentriq'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0534533,"In IMpower130, ACnP prolonged PFS and OS relative to CnP in patients without EGFR or ALK genetic aberrations.","[{'ForeName': 'Sohita', 'Initials': 'S', 'LastName': 'Dhillon', 'Affiliation': 'Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.'}, {'ForeName': 'Yahiya Y', 'Initials': 'YY', 'LastName': 'Syed', 'Affiliation': 'Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. demail@springer.com.'}]",Targeted oncology,['10.1007/s11523-019-00686-w'] 1077,31864178,Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials.,"BACKGROUND Previous analyses of BREAK-2 and BREAK-3 showed that durable outcomes lasting ≥3 years are achievable with dabrafenib in some patients with BRAF V600-mutant metastatic melanoma (MM); however, additional follow-up is needed to fully characterise the long-term impact of dabrafenib in these patients. METHODS BREAK-2 was a single-arm phase 2 study evaluating dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM. BREAK-3, a randomised (3:1) phase 3 study, assessed dabrafenib versus dacarbazine in previously untreated unresectable or metastatic BRAF V600E-mutant melanoma. Five-year analyses were performed. RESULTS All BREAK-2 patients (N = 92 [V600E, n = 76; V600K, n = 16]) discontinued treatment by the data cutoff. Median follow-up was 13.0 months. In BRAF V600E patients, 5-year progression-free survival (PFS) and overall survival (OS) were 11% and 20%, respectively. Subsequent immunotherapy was received by 22% of patients. In BREAK-3, median follow-up was 17.0 and 12.0 months in the dabrafenib (n = 187) and dacarbazine (n = 63) arms, respectively. Thirty-seven patients (59%) receiving dacarbazine crossed over to dabrafenib following disease progression as per protocol. Five-year PFS was 12% in the dabrafenib arm; all dacarbazine-arm patients progressed or were censored by 5 years. Dabrafenib improved PFS versus dacarbazine, regardless of baseline lactate dehydrogenase levels. Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively. Subsequent therapy in each arm included anti-CTLA-4 (dabrafenib [24%] and dacarbazine [24%]) and/or anti-PD-1 (8% and 2%) treatment. No new safety signals were observed. CONCLUSIONS AND RELEVANCE These data, representing extended follow-up for dabrafenib monotherapy, demonstrate that durable benefit lasting ≥5 years is achievable in a subset of patients. TRIAL REGISTRATION ClinicalTrials.gov (BREAK-2, NCT01153763; BREAK-3, NCT01227889).",2020,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","['previously untreated unresectable or metastatic BRAF V600E-mutant melanoma', 'patients with BRAF V600-mutant metastatic melanoma (MM', 'patients with BRAF V600-mutant metastatic melanoma receiving']","['dabrafenib versus dacarbazine', 'dabrafenib monotherapy', 'dacarbazine', 'dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM', 'dabrafenib']","['baseline lactate dehydrogenase levels', '5-year progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",37.0,0.387792,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. Electronic address: ahauschild@dermatology.uni-kiel.de.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione ""G. Pascale,"" Naples, Italy.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kiecker', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Lev V', 'Initials': 'LV', 'LastName': 'Demidov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'APHP Dermatology and CIC Department, Hôpital Saint-Louis, INSERM U976, University Paris Diderot, Paris, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Haas', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': ""D'Amelio"", 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Bijoyesh', 'Initials': 'B', 'LastName': 'Mookerjee', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Chapman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.033'] 1078,30926571,Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa.,"OBJECTIVE To examine whether maternal depressed mood at birth moderated the protective effect of a home-visiting intervention on the quality of caregiving for children growing up in a low- and middle-income country. METHOD Almost all pregnant mothers in 24 Cape Town neighborhoods were recruited into a cluster randomized controlled trial matched by neighborhoods to the Philani home-visiting condition (HVC) or the standard care condition (SC). At 3 years after birth, the quality of mother-child interactions between HVC and SC mothers with and without antenatal depressed mood was assessed in a representative subset by rating videotaped observations of mother-child interactions on 10 dimensions of caregiving. RESULTS As predicted, maternal depressed mood at birth moderated the effect of the HVC on the quality of mother-child interactions. Among nondepressed mothers, mothers and their children in the HVC scored significantly higher on 5 of the 10 dimensions of the maternal-child interaction scale than mothers in the SC: mothers exhibited more maternal sensitivity, talked more, had more harmonious interactions, and had children who paid more attention and exhibited more positive affect. However, being in the HVC did not significantly affect the mother-child interaction scores among mothers with depressed mood. Among HVC children, those with mothers with depressed mood showed significantly less positive affect and talked less with their mothers than children with nondepressed mothers. SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers. CONCLUSION Home visiting resulted in a better quality of caregiving for mothers without depressive symptoms. Future interventions need to specifically target maternal depression and positive mother-child interactions. CLINICAL TRIAL REGISTRATION INFORMATION Mentor Mothers: A Sustainable Family Intervention in South African Townships; https://clinicaltrials.gov; NCT00972699; Philani Home-based Nutrition Intervention Program; https://clinicaltrials.gov; NCT00995592.",2019,"SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers. ","['South Africa', 'pregnant mothers in 24 Cape Town neighborhoods', 'children growing up in a low- and middle-income country', 'Mentor Mothers', 'SC children with mothers with depressed mood', 'mothers without depressive symptoms']","['HVC', 'neighborhoods to the Philani home-visiting condition (HVC) or the standard care condition (SC', 'home-visiting intervention']","['maternal sensitivity', 'quality of mother-child interactions', 'quality of caregiving', 'maternal-child interaction scale', 'Quality of Mother and Child Interactions', 'mother-child interaction scores']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0396728,"SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers. ","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Christodoulou', 'Affiliation': 'Semel Institute, University of California-Los Angeles. Electronic address: jchristodoulou@mednet.ucla.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Semel Institute, University of California-Los Angeles.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Bradley', 'Affiliation': 'Institute for Life Course Health Research, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Stellenbosch University, Stellenbosch, South Africa; School of Nursing and Midwifery, Queens University, Belfast, UK.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.03.016'] 1079,31755321,Intrigue: Phase III study of ripretinib versus sunitinib in advanced gastrointestinal stromal tumor after imatinib.,"Ripretinib (DCC-2618) is a novel, type II tyrosine switch control inhibitor designed to broadly inhibit activating and drug-resistant mutations in KIT and PDGFRA . Ripretinib has emerged as a promising investigational agent for the treatment of gastrointestinal stromal tumor owing to targeted inhibition of secondary resistance mutations that may develop following treatment with prior line(s) of tyrosine kinase inhibitors. Here we describe the rationale and design of intrigue (NCT03673501), a global, randomized (1:1), open-label, Phase III study comparing the safety and efficacy of ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumor following imatinib. The primary end point is progression-free survival and key secondary objectives include objective response rate and overall survival. Clinical Trial Registration: NCT03673501.",2020,Ripretinib has emerged as a promising investigational agent for the treatment of gastrointestinal stromal tumor owing to targeted inhibition of secondary resistance mutations that may develop following treatment with prior line(s) of tyrosine kinase inhibitors.,"['patients with advanced gastrointestinal stromal tumor following imatinib', 'advanced gastrointestinal stromal tumor after imatinib']","['Ripretinib (DCC-2618', 'ripretinib versus sunitinib']","['progression-free survival', 'objective response rate and overall survival', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0380732,Ripretinib has emerged as a promising investigational agent for the treatment of gastrointestinal stromal tumor owing to targeted inhibition of secondary resistance mutations that may develop following treatment with prior line(s) of tyrosine kinase inhibitors.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nemunaitis', 'Affiliation': 'The University of Toledo College of Medicine & Life Sciences, Toledo, OH\xa043606, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'West German Cancer Center, Deparment of Medical Oncology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Centre Léon Bérard, Unicancer, LYRICAN and Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Choucair', 'Affiliation': 'The University of Toledo College of Medicine & Life Sciences, Toledo, OH\xa043606, USA.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, MA\xa002215, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'University Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Margaret von', 'Initials': 'MV', 'LastName': 'Mehren', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA 19111, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, School of Public Health & Preventive Medicine, Monash University & Department of Medical Oncology Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Haroun', 'Initials': 'H', 'LastName': 'Achour', 'Affiliation': 'Deciphera Pharmaceuticals, LLC, Waltham, MA 02451, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ruiz-Soto', 'Affiliation': 'Deciphera Pharmaceuticals, LLC, Waltham, MA 02451, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Heinrich', 'Affiliation': 'Portland VA Health Care System & OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR 97239, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0633'] 1080,31146547,Therapy competence in delivering a brief cognitive behavioural therapy intervention to reduce maternal anxiety associated with child food allergy.,"Child food allergy is increasingly prevalent, and caring for such children is associated with elevated parental anxiety. We previously carried out a randomized-controlled trial (RCT) of brief cognitive behavioural therapy (CBT) for parental anxiety associated with child food allergy which found that treatment to be effective. This study describes the manualized brief CBT intervention and assesses the acquisition of competence in delivering this therapy. Three healthcare professionals were trained and supervised in the delivery of brief CBT to 98 mothers of food-allergic children. Competency was assessed using the Revised Cognitive Therapy Scale (CTS-R), with 'competency' defined as a CTS-R score ≥3. All therapists' CTS-R scores increased over time. In the first four months, the mean (SD) CTS-R score was 2.31 (0.56), increasing to 3.14 (0.41) in the second four months ( p < .001). Overall, 13/19 (68%) of CBT sessions were rated with a CTS-R score ≥3 in the second four months. After eight months, all therapists were performing CBT at a competent level (17 of the 18 sessions or 94%). The therapists participated in a RCT that reduced maternal anxiety (reported elsewhere). We have shown that therapists not previously trained in CBT can be trained in specific interventions and reach competent levels quickly.",2019,"After eight months, all therapists were performing CBT at a competent level (17 of the 18 sessions or 94%).",['98 mothers of food-allergic children'],"['cognitive behavioural therapy intervention', 'manualized brief CBT intervention', 'cognitive behavioural therapy (CBT']","[""Revised Cognitive Therapy Scale (CTS-R), with 'competency' defined as a CTS-R score ≥3"", 'mean (SD) CTS-R score', 'maternal anxiety', 'maternal anxiety associated with child food allergy']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0222045'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}]",,0.0350675,"After eight months, all therapists were performing CBT at a competent level (17 of the 18 sessions or 94%).","[{'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Vickers', 'Affiliation': ""1 South West London and St Georges' Mental Health NHS Trust, Springfield Hospital, London, UK.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Boyle', 'Affiliation': '2 Department of Paediatrics, Imperial College London, London, UK.'}, {'ForeName': 'Thisanayagam', 'Initials': 'T', 'LastName': 'Umasunthar', 'Affiliation': '2 Department of Paediatrics, Imperial College London, London, UK.'}, {'ForeName': 'Jared G', 'Initials': 'JG', 'LastName': 'Smith', 'Affiliation': ""4 Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hodes', 'Affiliation': '5 Centre for Psychiatry, Imperial College London, London, UK.'}]",Journal of child health care : for professionals working with children in the hospital and community,['10.1177/1367493519853436'] 1081,31131912,Temporal dynamic modulation of acute stress on error processing in healthy males.,"Error processing is critical for adaptive behaviors. Acute stress has been found to influence error processing. However, the neural dynamic correlates underlying this modulation remain elusive. To address this issue, we recruited 39 healthy male participants, who performed a two-session task before and after an acute stress test while their behavioral and EEG data were recorded. The participants were randomly exposed to either a stress condition (Maastricht Acute Stress Test) or a control condition. The stress test consisted of several hand immersion tasks (ice-cold water, 2°C) and mental arithmetic tasks. A color-word Stroop task was used to investigate the stress effect on error responses. Based on the level of stress-induced cortisol, the participants in the stress group were further classified as low (N = 13) or high (N = 13) cortisol responders. The results indicated that only in the high cortisol responders, the error-related negativity (ERN) amplitude was reduced after acute stress. In addition, the ∆ERN in the high cortisol responders was significantly smaller than that in the low cortisol responders. These results suggest that acute stress impairs error detection. However, the error positivity amplitudes increased in the stress group compared to the control group, indicating that acute stress leads to greater error assessment. Taken together, these results suggest that acute stress impairs error detection, which is modulated by individuals' response level following acute stress, and leads to more emotional and/or motivational responses to the error signal once the error is consciously realized.",2019,"The results indicated that only in the high cortisol responders, the error-related negativity (ERN) amplitude was reduced after acute stress.","['39 healthy male participants', 'healthy males']","['stress condition (Maastricht Acute Stress Test) or a control condition', 'several hand immersion tasks (ice-cold water, 2°C) and mental arithmetic tasks']","['error positivity amplitudes', 'error-related negativity (ERN) amplitude']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0456963', 'cui_str': 'Ice cold - sensation (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",39.0,0.0168135,"The results indicated that only in the high cortisol responders, the error-related negativity (ERN) amplitude was reduced after acute stress.","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Quanshan', 'Initials': 'Q', 'LastName': 'Long', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Antao', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}]",Psychophysiology,['10.1111/psyp.13398'] 1082,31132209,Effects of game-based and standard executive control training on cognitive and academic abilities in elementary school children.,"Several studies indicate that executive functions (EF), such as working memory (WM), inhibition or flexibility can be improved by training and that these training-related benefits in WM capacity generalize to reading and mathematical abilities. However, the results of these studies are inconsistent and most of them focused on WM training in children with learning difficulties. Evidence for typically developing children is rare and no study has investigated inhibition training or flexibility training. There is also a lack of studies taking motivational factors into account. Therefore, this study compared the effects of game-based and standard training regimens targeting WM, inhibition, or flexibility in children. One hundred and fifty-three typically developing elementary school students (mean age = 9.6 years, standard deviations  = 0.8) were investigated in an intervention design with a pretest, 21 sessions of training, a posttest and a follow-up after three months. They were randomized into one of six training groups or a control group. We found training gains in all training groups and higher self-reported motivation in the game-based as compared to the standard training groups. Furthermore, there was domain-specific transfer to untrained EF tasks across all training groups. We found greater performance improvements in reading ability (but not mathematics) in the game-based flexibility training group and the game-based inhibition training group as compared to the control group. Transfer effects were still significant at follow-up. In sum, our findings provide first evidence for a systematic comparison of training on different domains of EF and their differential effects on academic abilities.",2020,We found training gains in all training groups and higher self-reported motivation in the game-based as compared to the standard training groups.,"['children', 'One hundred and fifty-three typically developing elementary school students (mean age\xa0', 'elementary school children', 'children with learning difficulties']",['game-based and standard executive control training'],"['Transfer effects', 'cognitive and academic abilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0424939', 'cui_str': 'Learning difficulties (finding)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",153.0,0.0126508,We found training gains in all training groups and higher self-reported motivation in the game-based as compared to the standard training groups.,"[{'ForeName': 'Verena E', 'Initials': 'VE', 'LastName': 'Johann', 'Affiliation': 'Department of Psychology, University of Koblenz-Landau, Landau in der Pfalz, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Karbach', 'Affiliation': 'Department of Psychology, University of Koblenz-Landau, Landau in der Pfalz, Germany.'}]",Developmental science,['10.1111/desc.12866'] 1083,31122901,"Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial.","BACKGROUND Atezolizumab (a monoclonal antibody against PD-L1), which restores anticancer immunity, improved overall survival in patients with previously treated non-small-cell lung cancer and also showed clinical benefit when combined with chemotherapy as first-line treatment of non-small-cell lung cancer. IMpower130 aimed to assess the efficacy and safety of atezolizumab plus chemotherapy versus chemotherapy alone as first-line therapy for non-squamous non-small-cell lung cancer. METHODS IMpower130 was a multicentre, randomised, open-label, phase 3 study done in 131 centres across eight countries (the USA, Canada, Belgium, France, Germany, Italy, Spain, and Israel). Eligible patients were aged 18 years or older, and had histologically or cytologically confirmed stage IV non-squamous non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0 or 1, and received no previous chemotherapy for stage IV disease. Patients were randomly assigned (2:1; permuted block [block size of six] with an interactive voice or web response system) to receive atezolizumab (1200 mg intravenously every 3 weeks) plus chemotherapy (carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m 2 intravenously every week]) or chemotherapy alone for four or six 21-day cycles followed by maintenance therapy. Stratification factors were sex, baseline liver metastases, and PD-L1 tumour expression. Co-primary endpoints were investigator-assessed progression-free survival and overall survival in the intention-to-treat wild-type (ie, EGFR wt and ALK wt ) population. The safety population included patients who received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, number NCT02367781. FINDINGS Between April 16, 2015, and Feb 13, 2017, 724 patients were randomly assigned and 723 were included in the intention-to-treat population (one patient died before randomisation, but was assigned to a treatment group; this patient was excluded from the intention-to-treat population) of the atezolizumab plus chemotherapy group (483 patients in the intention-to-treat population and 451 patients in the intention-to-treat wild-type population) or the chemotherapy group (240 patients in the intention-to-treat population and 228 patients in the intention-to-treat wild-type population). Median follow-up in the intention-to-treat wild-type population was similar between groups (18·5 months [IQR 15·2-23·6] in the atezolizumab plus chemotherapy group and 19·2 months [15·4-23·0] in the chemotherapy group). In the intention-to-treat wild-type population, there were significant improvements in median overall survival (18·6 months [95% CI 16·0-21·2] in the atezolizumab plus chemotherapy group and 13·9 months [12·0-18·7] in the chemotherapy group; stratified hazard ratio [HR] 0·79 [95% CI 0·64-0·98]; p=0·033) and median progression-free survival (7·0 months [95% CI 6·2-7·3] in the atezolizumab plus chemotherapy group and 5·5 months [4·4-5·9] in the chemotherapy group; stratified HR 0·64 [95% CI 0·54-0·77]; p<0·0001]). The most common grade 3 or worse treatment-related adverse events were neutropenia (152 [32%] of 473 in the atezolizumab plus chemotherapy group vs 65 [28%] of 232 in the chemotherapy group), anaemia (138 [29%] vs 47 [20%]), and decreased neutrophil count (57 [12%] vs 19 [8%]). Treatment-related serious adverse events were reported in 112 (24%) of 473 patients in the atezolizumab plus chemotherapy group and 30 (13%) of 232 patients in the chemotherapy group. Treatment-related (any treatment) deaths occurred in eight (2%) of 473 patients in the atezolizumab plus chemotherapy group and one (<1%) of 232 patients in the chemotherapy group. INTERPRETATION IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations. No new safety signals were identified. This study supports the benefit of atezolizumab, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer. FUNDING F. Hoffmann-La Roche.",2019,"INTERPRETATION IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations.","['patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations', 'Between April 16, 2015, and Feb 13, 2017', '724 patients were randomly assigned and 723 were included in the intention-to-treat population (one patient died before randomisation', 'Eligible patients were aged 18 years or older, and had histologically or cytologically confirmed stage IV non-squamous non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0 or 1, and received no previous chemotherapy for stage IV disease', '0·79', '131 centres across eight countries (the USA, Canada, Belgium, France, Germany, Italy, Spain, and Israel', 'patients with previously treated non-small-cell lung cancer', 'patients who received at least one dose of the study drug', 'metastatic non-squamous non-small-cell lung cancer (IMpower130', 'non-squamous non-small-cell lung cancer', 'group (240 patients in the intention-to-treat population and 228 patients in the intention-to-treat wild-type population']","['atezolizumab plus chemotherapy group (483 patients in the intention-to-treat population and 451 patients in the intention-to-treat wild-type population) or the chemotherapy', 'chemotherapy alone', 'chemotherapy (carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m 2 intravenously every week]) or chemotherapy alone', 'platinum-based chemotherapy', 'block [block size of six] with an interactive voice or web response system) to receive atezolizumab', 'carboplatin plus nab-paclitaxel chemotherapy', 'Atezolizumab', 'atezolizumab plus chemotherapy versus chemotherapy', 'atezolizumab', 'atezolizumab plus chemotherapy']","['hazard ratio [HR', 'anaemia', 'efficacy and safety', 'median progression-free survival', 'progression-free survival', 'investigator-assessed progression-free survival and overall survival', 'neutropenia', 'median overall survival', 'serious adverse events', 'overall survival', 'neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517866', 'cui_str': 'Seven hundred and twenty-three'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",724.0,0.387435,"INTERPRETATION IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations.","[{'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'West', 'Affiliation': 'Thoracic Oncology Program, Swedish Cancer Institute, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCleod', 'Affiliation': 'Sarah Cannon Research Institute, Florida Cancer Specialists, Fort Myers, FL, USA.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Sarah Cannon Research Institute, Florida Cancer Specialists, Leesburg, FL, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Thoracic Medical Oncology, National Cancer Institute, IRCCS Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Rittmeyer', 'Affiliation': 'Department of Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen, Germany.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Conter', 'Affiliation': 'Department of Medicine, William Osler Health System, Brampton, ON, Canada.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert Bosch Centrum für Tumorerkrankungen, Klinik Schillerhöhe, Stuttgart, Germany.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, TN, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McCune', 'Affiliation': 'Northwest Georgia Oncology Centers, Marietta, GA, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mekhail', 'Affiliation': 'Florida Hospital Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Zer', 'Affiliation': 'Thoracic Oncology Unit, Rabin Medical Center, Tel Aviv University, Petah-Tikva, Israel.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Thoracic Oncology, Asklepios Clinics Munich-Gauting, Gauting, Germany.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sadiq', 'Affiliation': 'Fort Wayne Medical Oncology and Hematology, Fort Wayne, IN, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sandler', 'Affiliation': 'Clinical Science, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Clinical Science, Genentech, South San Francisco, CA, USA; Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Ochi Lohmann', 'Affiliation': 'PD Oncology, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Venice', 'Initials': 'V', 'LastName': 'Archer', 'Affiliation': 'PD Oncology, Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kowanetz', 'Affiliation': 'Oncology Biomarker Development, Genentech, South San Francisco, CA, USA; Biotherapeutics, Inc., Redwood City, CA, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Cappuzzo', 'Affiliation': 'Department of Oncology and Hematology, AUSL Romagna, Ravenna, Italy. Electronic address: f.cappuzzo@gmail.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30167-6'] 1084,31759183,Randomized masked trial of the clinical efficacy of MGO Manuka Honey microemulsion eye cream for the treatment of blepharitis.,"PURPOSE To assess the clinical efficacy of a novel MGO Manuka Honey microemulsion (MHME) eye cream for the management of blepharitis. METHODS Fifty-three participants (32 females, 21 males; mean ± SD age, 60 ± 12 years) with clinical signs of blepharitis were enrolled in a prospective, investigator-masked, randomized, paired-eye trial. The MHME eye cream (Manuka Health New Zealand) was applied to the closed eyelids of one eye (randomized) overnight for 3 months. Visual acuity, ocular surface characteristics, symptoms and tear film parameters were assessed at baseline, day 30, and day 90. Eyelid swab microbiology cultures were evaluated at baseline and day 90. RESULTS Baseline measurements did not differ between treated and control eyes (all p > 0.05). Significant reductions in SANDE and SPEED symptomology scores were detected in treated eyes on days 30 and 90 (all p < 0.05), while clinical improvements in non-invasive tear film breakup time, lipid layer thickness, and inferior lid wiper epitheliopathy were observed on day 90 (all p < 0.05). Following the 3-month treatment period, ocular Demodex, Corynebacterium macginleyi, Propionibacterium acnes, and Staphylococcus epidermidis load decreased significantly in treated eyes (all p ≤ 0.001). There were no changes in visual acuity during the 90-day period (all p > 0.05), and no major adverse events were reported. CONCLUSION Topical overnight application of the MHME eye cream effected significant improvements in ocular surface symptomology, tear film stability and lipid layer thickness, and reduced lid margin staining, ocular Demodex and bacterial load. The favourable clinical efficacy and tolerability profile suggests promise for the MHME eye cream as a treatment for blepharitis management. TRIAL REGISTRATION NUMBER ACTRN12616000539437.",2020,"Significant reductions in SANDE and SPEED symptomology scores were detected in treated eyes on days 30 and 90 (all p < 0.05), while clinical improvements in non-invasive tear film breakup time, lipid layer thickness, and inferior lid wiper epitheliopathy were observed on day 90 (all p < 0.05).","['blepharitis', 'Fifty-three participants (32 females, 21 males; mean\u202f±\u202fSD age, 60\u202f±\u202f12 years) with clinical signs of blepharitis']","['MGO Manuka Honey microemulsion eye cream', 'MHME eye cream', 'novel MGO Manuka Honey microemulsion (MHME) eye cream', 'MHME eye cream (Manuka Health New Zealand']","['non-invasive tear film breakup time, lipid layer thickness, and inferior lid wiper epitheliopathy', 'SANDE and SPEED symptomology scores', 'ocular Demodex, Corynebacterium macginleyi, Propionibacterium acnes, and Staphylococcus epidermidis load', 'ocular surface symptomology, tear film stability and lipid layer thickness, and reduced lid margin staining, ocular Demodex and bacterial load', 'Eyelid swab microbiology cultures', 'Visual acuity, ocular surface characteristics, symptoms and tear film parameters', 'visual acuity']","[{'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]","[{'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0993163', 'cui_str': 'Ophthalmic Cream'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0323683', 'cui_str': 'Demodex (organism)'}, {'cui': 'C1007419', 'cui_str': 'Corynebacterium macginleyi (organism)'}, {'cui': 'C0033477', 'cui_str': 'Propionibacterium acnes'}, {'cui': 'C0038174', 'cui_str': 'Staphylococcus epidermidis'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure (procedure)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",53.0,0.0480352,"Significant reductions in SANDE and SPEED symptomology scores were detected in treated eyes on days 30 and 90 (all p < 0.05), while clinical improvements in non-invasive tear film breakup time, lipid layer thickness, and inferior lid wiper epitheliopathy were observed on day 90 (all p < 0.05).","[{'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cruzat', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Ophthalmology Department, Pontificia Universidad Católica of Chile, Santiago, Chile.'}, {'ForeName': 'Isabella M Y', 'Initials': 'IMY', 'LastName': 'Cheung', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'Watters', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}]",The ocular surface,['10.1016/j.jtos.2019.11.009'] 1085,31131621,Can Parental Engagement in Social Media Enhance Outcomes of an Online Healthy Lifestyle Program for Preschool-Aged Children?,"This study explored parental engagement, child BMI and secondary outcomes from the social media component of an online healthy lifestyle program for parents of preschool-aged children. Intervention group participants received access to an online program and Facebook group. Data were collected at baseline and 3- and 6-months follow-up. Facebook usage data on comments and posts were used to determine total active engagement. There was a high level of Facebook group membership and most parents actively engaged at least once. Although there were varying levels of engagement between modules and cohorts, it was modest overall. User acceptability of the Facebook group was lower than expected. Children of parents in the intervention who engaged more in the Facebook group (by posting and commenting) demonstrated greater sleep duration over time (estimate 1.79, 95% CI 0.42 to 3.17, p = .01 ) Children of parents who engaged more in the Facebook group also participated in less moderate- to vigorous-intensity physical activity (estimate -0.14, 95% CI -0.26 to -0.01, p = .03 ). This study is one of the first parent-focussed healthy lifestyle interventions to include a social media component. Further research is recommended with larger sample sizes and longer duration to further explore the potential of social media in childhood obesity interventions.",2020,"Children of parents in the intervention who engaged more in the Facebook group (by posting and commenting) demonstrated greater sleep duration over time (estimate 1.79, 95% CI 0.42 to 3.17, p = .01 )","['Preschool-Aged Children', 'parents of preschool-aged children']","['access to an online program and Facebook group', 'Online Healthy Lifestyle Program', 'social media component of an online healthy lifestyle program']","['User acceptability', 'sleep duration', 'moderate- to vigorous-intensity physical activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0264559,"Children of parents in the intervention who engaged more in the Facebook group (by posting and commenting) demonstrated greater sleep duration over time (estimate 1.79, 95% CI 0.42 to 3.17, p = .01 )","[{'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Hammersley', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong.'}, {'ForeName': 'Marijka J', 'Initials': 'MJ', 'LastName': 'Batterham', 'Affiliation': 'Statistical Consulting Service, National Institute for Applied Statistics Research Australia, School of Mathematics and Applied Statistics, University of Wollongong.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong.'}]",Health communication,['10.1080/10410236.2019.1620423'] 1086,31162597,Glucose- and Lipid-Related Biomarkers Are Affected in Healthy Obese or Hyperglycemic Adults Consuming a Whole-Grain Pasta Enriched in Prebiotics and Probiotics: A 12-Week Randomized Controlled Trial.,"BACKGROUND Synbiotic foods, which combine the action of prebiotics and probiotics along the gastrointestinal tract, can affect inflammatory and glucose-related markers. OBJECTIVE The aim of this study was to investigate the effects on inflammatory and glycemia-related markers of a whole-grain pasta containing barley β-glucans and Bacillus coagulans BC30, 6086 in healthy overweight or obese volunteers. METHODS A single-blind, parallel, randomized, placebo-controlled dietary intervention study was carried out. Forty-one healthy sedentary overweight (body mass index [BMI] 25-29.9 kg/m2) and obese (BMI ≥30) volunteers, aged 30-65 y and low consumers of fruit and vegetables, ate 1 serving/d of whole-grain control (CTR) or innovative (INN) pasta for 12 wk and maintained their habitual diets. Biological samples were collected at baseline and every 4 wk for primary (plasma high-sensitivity C-reactive protein [hs-CRP] and fasting plasma lipid profile) and secondary outcomes (glycemia-related markers, blood pressure, fecal microbiota composition, and body weight). Between (CTR compared with INN) and within (among weeks) group differences were tested for the whole population and for subgroups stratified by baseline values of BMI (≥30) and glycemia (≥100 mg/dL). RESULTS INN or CTR pasta consumption had no effect on primary and secondary outcomes over time, except for a significant increase in plasma γ-glutamyltransferase (GGT) after 12 wk of CTR pasta consumption. Comparisons between intervention groups revealed differences only at 12 wk: plasma GGT was higher in the CTR group; plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp. were lower in the INN subgroup of obese volunteers; plasma resistin was lower and Faecalibacterium prausnitzii abundance was higher in the INN subgroup of hyperglycemic volunteers. CONCLUSIONS A daily serving of a synbiotic whole-grain pasta had limited effects on primary and secondary outcomes in the entire group of volunteers but affected glycemia- and lipid-related markers and resistin in a subgroup of healthy obese or hyperglycemic volunteers. This trial was registered at clinicaltrials.gov as NCT02236533.",2019,"Comparisons between intervention groups revealed differences only at 12 wk: plasma GGT was higher in the CTR group; plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp.","['BMI] 25-29.9 kg/m2) and obese (BMI ≥30) volunteers, aged 30-65 y and low consumers of fruit and vegetables, ate 1 serving/d of whole-grain control (CTR) or innovative (INN) pasta for 12 wk and maintained their habitual diets', 'Forty-one healthy sedentary overweight (body mass index', 'Healthy Obese or Hyperglycemic Adults Consuming a Whole-Grain Pasta Enriched in Prebiotics and Probiotics', 'healthy overweight or obese volunteers', 'healthy obese or hyperglycemic volunteers']","['placebo-controlled dietary intervention', 'synbiotic whole-grain pasta']","['plasma γ-glutamyltransferase (GGT', 'fasting plasma lipid profile) and secondary outcomes (glycemia-related markers, blood pressure, fecal microbiota composition, and body weight', 'plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp', 'Faecalibacterium prausnitzii abundance', 'plasma GGT']","[{'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0317558', 'cui_str': 'Fusobacterium prausnitzii'}]",41.0,0.183307,"Comparisons between intervention groups revealed differences only at 12 wk: plasma GGT was higher in the CTR group; plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp.","[{'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Angelino', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Martina', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Veronesi', 'Affiliation': 'Public Health Unit, Department of Medicine and Surgery.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Antonini', 'Affiliation': 'Division of Endocrinology, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Ilario', 'Initials': 'I', 'LastName': 'Mennella', 'Affiliation': 'Department of Agricultural and Food Science, University of Naples ""Federico II"", Portici, Naples, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural and Food Science, University of Naples ""Federico II"", Portici, Naples, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Grioni', 'Affiliation': 'Epidemiology and Prevention Unit, Fondazione IRCSS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Zavaroni', 'Affiliation': 'Division of Endocrinology, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fares', 'Affiliation': 'Council for Agricultural Research and Economics-Centre for Cereal Research and Industrial Crops, Foggia, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Torriani', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Pellegrini', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}]",The Journal of nutrition,['10.1093/jn/nxz071'] 1087,31912695,Efficacy of remote limb ischemic conditioning on poststroke cognitive impairment.,"The impact of remote limb ischemic conditioning on poststroke cognitive impairment was evaluated with 104 first-time patients of noncardiac ischemic stroke. During the acute phase the patients were randomized into control and remote limb ischemic conditioning groups. Both groups received standard treatment, while the remote limb ischemic conditioning group received additional remote limb ischemic conditioning treatment for 6 months. All participants underwent neuropsychological evaluation, transcranial Doppler detection, P300 event-related potential and brachial-ankle pulse wave velocity measurements, and determination of serum intercellular adhesion molecule-1 and endothelin-1 levels both at admission and 6 months poststroke. The number of cases with poststroke cognitive impairment in each group was evaluated 6 months poststroke. No statistically significant difference was found in demographic data or baseline detection indices at admission between the two groups. However, at 6 months poststroke, the remote limb ischemic conditioning group had significantly higher total Montreal Cognitive Assessment score and its domains of visuospatial and executive functioning and attention scores, significantly lower activity of daily living scale score, shorter P300 latency, and higher amplitude compared with the control group. Moreover, the middle cerebral artery, average blood flow velocity was significantly higher, while the middle cerebral artery-pulsation index, basilar artery pulsation index, and the levels of brachial-ankle pulse wave velocity, intercellular adhesion molecule-1, and endothelin-1 were significantly lower in the remote limb ischemic conditioning group compared with the control group. These results demonstrate that remote limb ischemic conditioning causes a significant improvement in cognitive domains, such as visuospatial and executive functioning and attention, and is therefore linked with reduced incidence of poststroke cognitive impairment.",2019,"However, at 6 months poststroke, the remote limb ischemic conditioning group had significantly higher total Montreal Cognitive Assessment score and its domains of visuospatial and executive functioning and attention scores, significantly lower activity of daily living scale score, shorter P300 latency, and higher amplitude compared with the control group.",['104 first-time patients of noncardiac ischemic stroke'],"['remote limb ischemic conditioning group received additional remote limb ischemic conditioning treatment', 'remote limb ischemic conditioning']","['cognitive domains, such as visuospatial and executive functioning and attention', 'total Montreal Cognitive Assessment score and its domains of visuospatial and executive functioning and attention scores, significantly lower activity of daily living scale score, shorter P300 latency, and higher amplitude', 'poststroke cognitive impairment', 'demographic data or baseline detection indices at admission', 'number of cases with poststroke cognitive impairment', 'middle cerebral artery-pulsation index, basilar artery pulsation index, and the levels of brachial-ankle pulse wave velocity, intercellular adhesion molecule-1, and endothelin-1', 'middle cerebral artery, average blood flow velocity', 'transcranial Doppler detection, P300 event-related potential and brachial-ankle pulse wave velocity measurements, and determination of serum intercellular adhesion molecule-1 and endothelin-1 levels']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3) (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0004811', 'cui_str': 'Basilar Artery'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0282541', 'cui_str': 'Evoked Potentials, P300 Component'}, {'cui': 'C0436191', 'cui_str': 'Velocity measurement (procedure)'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0244125,"However, at 6 months poststroke, the remote limb ischemic conditioning group had significantly higher total Montreal Cognitive Assessment score and its domains of visuospatial and executive functioning and attention scores, significantly lower activity of daily living scale score, shorter P300 latency, and higher amplitude compared with the control group.","[{'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Soochow University, Jiangsu Province, 215006, P. R. China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, Zhabei Central Hospital, Jing'an District, Shanghai 200070, P. R. China.""}, {'ForeName': 'Zongwen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tianyou Hospital, Tongji University, Shanghai 200331, P. R. China.'}, {'ForeName': 'Luojun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Zhabei Central Hospital, Jing'an District, Shanghai 200070, P. R. China.""}, {'ForeName': 'Xunhao', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Department of Neurology, Zhabei Central Hospital, Jing'an District, Shanghai 200070, P. R. China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Zhabei Central Hospital, Jing'an District, Shanghai 200070, P. R. China.""}, {'ForeName': 'Shouru', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Soochow University, Jiangsu Province, 215006, P. R. China.'}]",Journal of integrative neuroscience,['10.31083/j.jin.2019.04.1192'] 1088,28002986,Evaluating the effects of copper supplement during pregnancy on premature rupture of membranes and pregnancy outcome.,"OBJECTIVE To evaluate the effects of copper (Cu) supplementation during pregnancy on the rupture of membranes and pregnancy outcomes. METHODS Study was conducted as a triple-blind randomized clinical trial. In one group, Cu in a dose of 1000 mg per day, and in the other group, placebo was prescribed orally from 16th week of pregnancy. RESULTS The women of the two groups did not have significant difference according to age, gestational age at recruitment, BMI, and socioeconomic conditions. There was no statistically significant difference between case and control group regarding the incidence of PPROM, PROM, preterm labor, vaginal bleeding during pregnancy, preeclampsia, and the incidence of placenta abruption. There was a 75% and 90% decrease in depressive symptoms in 2nd trimester and 3rd trimester in supplemented group, respectively. Also, there was a 45% and 80% decrease in anxiety symptoms in 2nd trimester and 3rd trimester in the supplemented group, respectively The rate of infection during pregnancy was significantly higher in control group (p = 0.046). There was no difference between the two groups according to neonatal outcomes. CONCLUSIONS Cu supplementation during pregnancy could not influence positively on ROM; however, it could improve some mood status of the women.",2018,"There was a 75% and 90% decrease in depressive symptoms in 2nd trimester and 3rd trimester in supplemented group, respectively.",[],"['copper supplement', 'placebo', 'Cu supplementation', 'copper (Cu) supplementation']","['depressive symptoms', 'ROM', 'rate of infection during pregnancy', 'anxiety symptoms', 'premature rupture of membranes and pregnancy outcome', 'incidence of PPROM, PROM, preterm labor, vaginal bleeding during pregnancy, preeclampsia, and the incidence of placenta abruption']",[],"[{'cui': 'C0521937', 'cui_str': 'Copper supplement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0729264', 'cui_str': 'PPROM'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C3163625', 'cui_str': 'Bleeding from female genital tract co-occurrent with pregnancy'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}]",,0.133679,"There was a 75% and 90% decrease in depressive symptoms in 2nd trimester and 3rd trimester in supplemented group, respectively.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'a Department of Obstetrics & Gynecology, Akbarabadi Teaching Hospital , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Hasti', 'Initials': 'H', 'LastName': 'Hadizadeh', 'Affiliation': 'b Medical Student Research Committee (MSRC), Faculty of Medicine, Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Faghankhani', 'Affiliation': 'c Research Associate, Tehran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Nazemi', 'Affiliation': 'd Social Security Organization , Bahman Hospital , Tehran , Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Sheikhansari', 'Affiliation': 'e Student of Public Health, Faculty of Medicine , University of Southampton , Southampton , UK.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2016.1274299'] 1089,31749412,Myocardial protection technique structured on cardiac mass.,"OBJECTIVE Myocardial protection is crucial in cardiac surgery: quantification is often difficult as there is a significant mismatch between body weight and heart weight as per geometric remodeling. This study has the objective to compare two groups of patients on the administration of myocardial protection in valvular pathologies: the first group has indexed the administration with left ventricular mass index; the second has indexed it on the body weight or on the body surface area. The primary endpoint of double-blind case-control study is to detect the difference in incidence in terms of post-operative low cardiac output syndrome. METHODS A single-center double-blind case-control study in a specialized regional tertiary cardiac surgery center in Italy. Between March 2017 and September 2018, 200 adults (100 per Group A vs. Group B) were scheduled for elective procedures: Group A (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation of left ventricular mass index with echocardiographic measures (Formula Group A); Group B (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation indexed on the body surface area, Du Bois Method (Formula Group B). RESULTS A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029). No statistically significant differences in patients undergoing mitral valve repair surgery. CONCLUSION The study group in the aortic valve surgery that administered myocardial protection indexed for the left ventricular mass index and showed a statistically significant lower incidence for post-operative low cardiac output syndrome compared to the control group.",2020,"A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029).","['patients undergoing mitral valve repair surgery', 'specialized regional tertiary cardiac surgery center in Italy', 'Between March 2017 and September 2018, 200 adults (100 per Group A vs. Group B) were scheduled for']","['elective procedures: Group A (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation of left ventricular mass index with echocardiographic measures (Formula Group A); Group B (50 aortic valve', 'Epinephrine', 'epinephrine', 'replacement-50 mitral valve repair in minimally invasive cardiac surgery']","['incidence in terms of post-operative low cardiac output syndrome', 'stroke volume shift']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0747973', 'cui_str': 'Elective procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0005768'}, {'cui': 'C0007200', 'cui_str': 'Cardioplegic Solutions'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]",200.0,0.0343474,"A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029).","[{'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Condello', 'Affiliation': 'Department of Cardiovascular Surgery, Anthea Hospital, GVM Care & Research, Bari, Italy.'}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Lancellotti', 'Affiliation': 'Department of Cardiology, University of Liège, Heart Valve Clinic, CHU Sart Tilman, Liège, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Speziale', 'Affiliation': 'Department of Cardiovascular Surgery, Anthea Hospital, GVM Care & Research, Bari, Italy.'}]",Perfusion,['10.1177/0267659119886717'] 1090,31145388,Effects of Maximal vs. Submaximal Isometric Fatiguing Exercise on Subsequent Submaximal Exercise Performance.,"Miller, WM, Ye, X, and Jeon, S. Effects of maximal vs. submaximal isometric fatiguing exercise on subsequent submaximal exercise performance. J Strength Cond Res 34(7): 1875-1883, 2020-Exercise-induced muscle fatigue directly influences subsequent exercise performance. Thus, we examined task failure times for submaximal intermittent fatiguing isometric contractions performed after a bout of sustained maximal vs. submaximal isometric fatiguing contractions with the dominant elbow flexors. Twenty physically active individuals 8 men (mean ± SD = 21.4 ± 1.8 years; 80.9 ± 12.5 kg; 180 ± 6.4 cm) and 12 women (mean ± SD = 21.4 ± 2.7; 66.8 ± 15.6 kg; 165.7 ± 7.1 cm) participated in a 3-visit randomized cross-over study. Visit 1 included familiarization, and 2 and 3 were randomized for sustained maximal (until force was below 50% of the maximal force value) or submaximal conditions (50% of maximal force until task failure), followed by submaximal intermittent isometric contractions to task failure. Surface electromyography was recorded through the biceps brachii during all fatiguing contractions. Task failure time was significantly shorter for the maximal compared with submaximal condition, and no significant difference in sex or condition was found for the subsequent fatiguing condition. Electromyography amplitude significantly increased in the submaximal intermittent isometric contractions from prefatigue and first and final postfatigue with no condition or sex differences. Electromyography mean frequency significantly decreased from prefatigue and first and final postfatigue for both sexes, with no condition or sex differences. With both maximal and submaximal exercises inducing the same level of force deficit, our results suggested that both exercises might have imposed a similar burden on the neuromuscular system, thereby not providing differential effects on the subsequent submaximal exercise performance.",2020,"Task failure time was significantly shorter for the maximal compared with submaximal condition, and no significant difference in sex or condition was found for the subsequent fatiguing condition.",['Twenty physically active individuals 8 men (mean ± SD = 21.4 ± 1.8 years; 80.9 ± 12.5 kg; 180 ± 6.4 cm) and 12 women (mean ± SD = 21.4 ± 2.7; 66.8 ± 15.6 kg; 165.7 ± 7.1 cm) participated in a 3-visit randomized cross-over study'],"['J Strength Cond Res XX(X', 'Maximal vs. Submaximal Isometric Fatiguing Exercise']","['Electromyography amplitude', 'Electromyography mean frequency', 'Task failure time', 'subsequent submaximal exercise performance', 'Subsequent Submaximal Exercise Performance']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",20.0,0.027755,"Task failure time was significantly shorter for the maximal compared with submaximal condition, and no significant difference in sex or condition was found for the subsequent fatiguing condition.","[{'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Miller', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, University of Mississippi, University, Mississippi.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Sunggun', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003200'] 1091,31748884,Laparoscopic Major Hepatectomy: Do Not Underestimate the Impact of Specimen Extraction Site.,"BACKGROUND In laparoscopic major hepatectomy, analysis of outcomes according to specimen extraction site remains poorly described. The aim was to compare postoperative outcomes according to specimen extraction site. METHODS From 2000 to 2017, all laparoscopic major hepatectomies were reviewed and postoperative outcomes were analyzed according to specimen extraction site: subcostal (Group 1), midline (Group 2), or suprapubic (Group 3) incision. RESULTS Among 163 patients, 15 (9.2%) belonged to Group 1, 49 (30.1%) in Group 2, and 99 (60.7%) in Group 3. The proportion of right-sided, left-sided, or central hepatectomies, mortality, and overall and severe complications were comparable between groups. Group 1 had larger tumors (61 vs. 38 vs. 47 mm; P = 0.014), higher operative time (338 vs. 282 vs. 260 min; P < 0.008), higher adjacent organ resection rate (46.6 vs. 16.3 vs. 7.1%; P < 0.001), and tended to increase pulmonary complications (40.0 vs. 12.2 vs. 18.2%; P = 0.064). In Group 2, a previous midline incision scar was more frequently used for specimen extraction site (65.3 vs. 26.6 and 30.3%, Group 1 and 3; P < 0.001). Postoperative incisional hernia was observed in 16.4% (n = 23) and was more frequent in Group 2 (26.6 vs. 6.6% and 10.1%, Group 1 and Group 3; P = 0.030). Finally, Group 2 (HR 2.63, 95% CI 1.41-3.53; P = 0.032) was the only independent predictive factor of postoperative incisional hernia. CONCLUSIONS While using a previous incision makes sense, the increased risk of postoperative incisional hernia after midline incision promotes the suprapubic incision.",2020,"Postoperative incisional hernia was observed in 16.4% (n = 23) and was more frequent in Group 2 (26.6 vs. 6.6% and 10.1%, Group 1 and Group 3; P = 0.030).","['From 2000 to 2017, all laparoscopic major hepatectomies']","['suprapubic (Group 3) incision', 'Laparoscopic Major Hepatectomy']","['pulmonary complications', 'higher adjacent organ resection rate', 'higher operative time', 'Postoperative incisional hernia', 'midline incision scar', 'risk of postoperative incisional hernia', 'proportion of right-sided, left-sided, or central hepatectomies, mortality, and overall and severe complications']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0205498', 'cui_str': 'Suprapubic approach (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}, {'cui': 'C0456276', 'cui_str': 'Midline incision (procedure)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0443246', 'cui_str': 'Left sided (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",163.0,0.0809945,"Postoperative incisional hernia was observed in 16.4% (n = 23) and was more frequent in Group 2 (26.6 vs. 6.6% and 10.1%, Group 1 and Group 3; P = 0.030).","[{'ForeName': 'Théophile', 'Initials': 'T', 'LastName': 'Guilbaud', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France. theo.guilbaud@gmail.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Feretti', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Waclaw', 'Initials': 'W', 'LastName': 'Holowko', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Giovanni Maria', 'Initials': 'GM', 'LastName': 'Garbarino', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Marchese', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sarran', 'Affiliation': 'Department of Radiology and Medical Imaging, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Beaussier', 'Affiliation': 'Department of Anesthesiology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Gayet', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fuks', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}]",World journal of surgery,['10.1007/s00268-019-05285-4'] 1092,31122893,Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study.,"BACKGROUND Patients with idiopathic pulmonary fibrosis (IPF) treated with PRM-151, a recombinant human pentraxin 2 protein, in a phase 2 double-blind, randomised controlled trial had significantly reduced decline in percentage of predicted forced vital capacity (FVC) and stabilised 6-min walking distance compared with placebo over a 28-week period. Here we report the 76-week results of an open-label extension study. METHODS Patients who completed the 28-week double-blind period of the PRM-151-202 trial were eligible to participate in the open-label extension study. Patients previously enrolled in the PRM-151 group continued this treatment and those previously in the placebo group crossed over to PRM-151. All patients received PRM-151 in 28-week cycles with loading doses of 10 mg/kg by 60 min intravenous infusions on days 1, 3, and 5 in the first week of each cycle followed by one infusion of 10 mg/kg every 4 weeks. The primary objective of the open-label extension study was to assess the long-term safety and tolerability of PRM-151, which were assessed by analysing adverse events (AEs) up to week 76 in all patients who received at least one dose of PRM-151 during the open-label extension study. Exploratory efficacy analyses were done by assessing changes from baseline in percentage of predicted FVC and 6-min walking distance, with descriptive statistics to week 76 and with random-intercept mixed models to week 52. This study is registered with ClinicalTrials.gov, number NCT02550873, and with EudraCT, number 2014-004782-24. FINDINGS Of 116 patients who completed the double-blind treatment period, 111 entered the open-label extension study (74 from the PRM-151 group and 37 from the placebo group). 84 (76%) of 111 patients received concomitant IPF therapy (pirfenidone n=55 or nintedanib n=29). AEs were consistent with long-term IPF sequelae. 31 (28%) patients had serious AEs. Those occurring in two or more patients were pneumonia (six [5%] of 111), IPF exacerbation (four [4%]), IPF progression (four [4%]), and chest pain (two [2%]). 21 (19%) patients had severe AEs, of which IPF exacerbation and IPF progression each occurred in two (2%) patients. Two (2%) patients experienced life-threatening AEs (one had pneumonia and one had small-cell lung cancer extensive stage). A persistent treatment effect was observed for PRM-151 in patients who continued treatment, with a decline in percentage of predicted FVC of -3·6% per year and in 6-min walking distance of -10·5 m per year at week 52. In patients who started PRM-151 during the open-label extension study, compared with the slopes for placebo, decline reduced for percentage of predicted FVC (from -8·7% per year in weeks 0-28 to -0·9% per year in weeks 28-52, p<0·0001) and 6-min walking distance (from -54·9 m per year to -3·5 m per year, p=0·0224). INTERPRETATION Long-term treatment with PRM-151 was well tolerated and the effects on percentage of predicted FVC and 6-min walking distance were persistent on continuation and positive in patients who crossed over from placebo. These findings support further study of PRM-151 in larger populations of patients with IPF. FUNDING Promedior.",2019,"INTERPRETATION Long-term treatment with PRM-151 was well tolerated and the effects on percentage of predicted FVC and 6-min walking distance were persistent on continuation and positive in patients who crossed over from placebo.","['Patients who completed the 28-week double-blind period of the PRM-151-202 trial were eligible to participate in the open-label extension study', 'patients with IPF', '116 patients who completed the double-blind treatment period, 111 entered the open-label extension study (74 from the PRM-151 group and 37 from the placebo group', 'patients with idiopathic pulmonary fibrosis', 'Patients with idiopathic pulmonary fibrosis (IPF) treated with']","['concomitant IPF therapy (pirfenidone', 'recombinant human pentraxin 2 protein', 'placebo', 'PRM-151', 'PRM-151, a recombinant human pentraxin 2 protein']","['forced vital capacity (FVC) and stabilised 6-min walking distance', 'percentage of predicted FVC', '6-min walking distance', 'chest pain', 'IPF exacerbation and IPF progression each', 'IPF progression', 'serious AEs', 'IPF exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2976397', 'cui_str': 'PRM-151'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2976397', 'cui_str': 'PRM-151'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.312157,"INTERPRETATION Long-term treatment with PRM-151 was well tolerated and the effects on percentage of predicted FVC and 6-min walking distance were persistent on continuation and positive in patients who crossed over from placebo.","[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'Center for Interstitial Lung Diseases, Department of Medicine and Laboratory Medicine, University of Washington, Seattle, WA, USA. Electronic address: graghu@uw.edu.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'van den Blink', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hamblin', 'Affiliation': 'Pulmonary and Critical Care Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'A Whitney', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Golden', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Ho', 'Affiliation': 'Center for Interstitial Lung Diseases, Department of Medicine and Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus MC, University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vasakova', 'Affiliation': 'Department of Respiratory Medicine, First Faculty of Medicine of Charles University and Thomayer Hospital, Prague, Czech Republic.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pesci', 'Affiliation': 'School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Antin-Ozerkis', 'Affiliation': 'Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Meyer', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Thoraxklinik, University of Heidelberg and German Center for Lung, Research, Heidelberg, Germany.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Moran', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Santin-Janin', 'Affiliation': 'Venn Life Sciences, Paris, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Aubin', 'Affiliation': 'Venn Life Sciences, Paris, France.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Mulder', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30172-9'] 1093,31122894,"Eosinophil-guided corticosteroid therapy in patients admitted to hospital with COPD exacerbation (CORTICO-COP): a multicentre, randomised, controlled, open-label, non-inferiority trial.","BACKGROUND Treatment with systemic corticosteroids in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) is associated with debilitating adverse effects. Therefore, strategies to reduce systemic corticosteroid exposure are urgently required and might be offered by a personalised biomarker-guided approach to treatment. The aim of this study was to determine whether an algorithm based on blood eosinophil counts could safely reduce systemic corticosteroid exposure in patients admitted to hospital with acute exacerbations of COPD. METHODS We did a multicentre, randomised, controlled, open-label, non-inferiority trial at the respiratory departments of three different university-affiliated hospitals in Denmark. Eligible participants were patients included within 24h of admission to the participating sites, aged at least 40 years, with known airflow limitation (defined as a post-bronchodilator FEV 1 /forced vital capacity [FVC] ratio ≤0·70) and a specialist-verified diagnosis of COPD, who were designated to start on systemic corticosteroids by the respiratory medicine physician on duty. We randomly assigned patients (1:1) to either eosinophil-guided therapy or standard therapy with systemic corticosteroids. Both investigators and patients were aware of the group assignment. All patients received 80 mg of intravenous methylprednisolone on the first day. The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3 × 10 9 cells per L. On days when the eosinophil count was lower, prednisolone was not administered. If a patient was discharged during the treatment period, a treatment based on the last measured eosinophil count was prescribed for the remaining days within the 5-day period (last observation carried forward). The control group received 37·5 mg of prednisolone tablets daily from the second day for 4 days. The primary outcome was the number of days alive and out of hospital within 14 days after recruitment, assessed by intention to treat (ITT). Secondary outcomes included treatment failure at day 30 (ie, recurrence of acute exacerbation of COPD resulting in emergency room visits, admission to hospital, or need to intensify pharmacological treatment), number of deaths on day 30, and duration of treatment with systemic corticosteroids. The non-inferiority margin was 1·2 days (SD 3·8). This trial is registered at ClinicalTrials.gov, number NCT02857842, and was completed in January, 2019. FINDINGS Between Aug 3, 2016, and Sept 30, 2018, 159 patients in the eosinophil-guided group and 159 patients in the control group were included in the ITT analyses. There was no between-group difference for days alive and out of hospital within 14 days after recruitment: mean 8·9 days (95% CI 8·3-9·6) in the eosinophil-guided group versus 9·3 days (8·7-9·9) in the control group (absolute difference -0·4, 95% CI -1·3 to 0·5; p=0·34). Treatment failure at 30 days occurred in 42 (26%) of 159 patients in the eosinophil-guided group and 41 (26%) of 159 in the control group (difference 0·6%, 95% CI -9·0 to 10·3; p=0·90). At 30 days nine patients (6%) of 159 in the eosinophil-guided group and six (4%) of 159 in the control group had died (difference 1·9%, 95% CI -2·8 to 6·5; p=0·43). Median duration of systemic corticosteroid therapy was lower in the eosinophil-guided group: 2 days (IQR 1·0 to 3·0) compared with 5 days (5·0 to 5·0) in the control group, p<0·0001. INTERPRETATION Eosinophil-guided therapy was non-inferior compared with standard care for the number of days alive and out of hospital, and reduced the duration of systemic corticosteroid exposure, although we could not entirely exclude harm on some secondary outcome measures. Larger studies will help to determine the full safety profile of this strategy and its role in the management of COPD exacerbations. FUNDING The Danish Regions Medical Fund and the Danish Council for Independent Research.",2019,There was no between-group difference for days alive and out of hospital within 14 days after recruitment:,"['respiratory departments of three different university-affiliated hospitals in Denmark', 'patients with acute exacerbations of chronic obstructive pulmonary disease (COPD', 'patients admitted to hospital with acute exacerbations of COPD', 'Between Aug 3, 2016, and Sept 30, 2018, 159 patients in the eosinophil-guided group and 159 patients in the control group were included in the ITT analyses', 'Eligible participants were patients included within 24h of admission to the participating sites, aged at least 40 years, with known airflow limitation (defined as a post-bronchodilator FEV 1 /forced vital capacity [FVC] ratio ≤0·70) and a specialist-verified diagnosis of COPD, who were designated to start on systemic corticosteroids by the respiratory medicine physician on duty', 'patients admitted to hospital with COPD exacerbation (CORTICO-COP']","['37·5 mg of prednisolone', 'Eosinophil-guided corticosteroid therapy', 'eosinophil-guided therapy or standard therapy with systemic corticosteroids', 'systemic corticosteroids', 'intravenous methylprednisolone', 'Eosinophil-guided therapy was non-inferior compared with standard care', 'prednisolone']","['number of days alive and out of hospital within 14 days after recruitment, assessed by intention to treat (ITT', 'Treatment failure', 'treatment failure at day 30 (ie, recurrence of acute exacerbation of COPD resulting in emergency room visits, admission to hospital, or need to intensify pharmacological treatment), number of deaths on day 30, and duration of treatment with systemic corticosteroids', 'Median duration of systemic corticosteroid therapy', 'eosinophil count', 'died']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0162643'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]",,0.360106,There was no between-group difference for days alive and out of hospital within 14 days after recruitment:,"[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark. Electronic address: pradeesh.s@dadlnet.dk.'}, {'ForeName': 'Therese S', 'Initials': 'TS', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus R', 'Initials': 'RR', 'LastName': 'Laub', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Bech', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Eklöf', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Freja S', 'Initials': 'FS', 'LastName': 'Holm', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Armbruster', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Praleene', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Mosbech', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Aras K M', 'Initials': 'AKM', 'LastName': 'Ali', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Seersholm', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Jon T', 'Initials': 'JT', 'LastName': 'Wilcke', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brøndum', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Tine P', 'Initials': 'TP', 'LastName': 'Sonne', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rønholt', 'Affiliation': 'Department of Internal Medicine, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle F', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark; Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jens-Ulrik S', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of infectious diseases, Rigshospitalet, Copenhagen, Denmark.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30176-6'] 1094,31115611,Preoperative predictors and a prediction score for perception of improvement after mesh prolapse surgery.,"INTRODUCTION AND HYPOTHESIS Pelvic organ prolapse (POP) surgery using a mesh has a complication rate of 26%, and an estimated 10% of those operated on do not consider it brings improvement. The objective of this study was to identify preoperative predictors of improvement after POP repair with mesh to develop a predictive score. METHODS This is a secondary analysis of the randomized multicenter trial PROSPERE, which compared morbidity after prolapse repair with mesh according to the vaginal or laparoscopic approach. Improved women [PGI-I score at 1-year follow-up = 1 (much better) or 2 (better)] were compared with unimproved women. Two hundred fifty-five women were included to derive the prediction score based on multiple logistic regression. An internal validation by bootstrapping estimated the unbiased performance of the model. RESULTS Criteria independently related to improvement were: (1) cystocele stage > II [OR: 2.93 95% CI (1.22-7.04), p = 0.015]; (2) preoperative expectation related to bulge symptom improvement [OR: 2.57 95% CI (1.07-6.04), p = 0.031] and (3) absence of chronic pelvic pain [OR: 4.55 95% CI (1.77-11.46), p = 0.001]. A score (scored from 0 to 11) was constructed from the aOR of the predictive model: the ROC-AUC of the score was 0.75, and a score ≥ 9 predicted a 97% chance of improvement (95% CI 92-99), with a specificity of 85% (95% CI 68-94). The ROC-AUC corrected for optimism by the bootstrap procedure was 0.70. CONCLUSIONS This score could be used by surgeons in preoperative counseling of women.",2020,"RESULTS Criteria independently related to improvement were: (1) cystocele stage > II [OR: 2.93 95% CI (1.22-7.04), p = 0.015]; (2) preoperative expectation related to bulge symptom improvement [OR: 2.57 95% CI (1.07-6.04), p = 0.031] and (3) absence of chronic pelvic pain [OR: 4.55 95% CI (1.77-11.46), p = 0.001].",['Two hundred fifty-five women'],[],['chronic pelvic pain'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]",255.0,0.208497,"RESULTS Criteria independently related to improvement were: (1) cystocele stage > II [OR: 2.93 95% CI (1.22-7.04), p = 0.015]; (2) preoperative expectation related to bulge symptom improvement [OR: 2.57 95% CI (1.07-6.04), p = 0.031] and (3) absence of chronic pelvic pain [OR: 4.55 95% CI (1.77-11.46), p = 0.001].","[{'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Chattot', 'Affiliation': 'EA 7285 Research Unit ""Risk and Safety in Clinical Medicine for Women and Perinatal Health"", Versailles-Saint-Quentin University (UVSQ), 78180, Montigny-le-Bretonneux, France. cchattot@gmail.com.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Deffieux', 'Affiliation': 'EA 7285 Research Unit ""Risk and Safety in Clinical Medicine for Women and Perinatal Health"", Versailles-Saint-Quentin University (UVSQ), 78180, Montigny-le-Bretonneux, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lucot', 'Affiliation': 'Gynecological Surgery Unit, Centre Hospitalier Universitaire Jeanne de Flandre, 59 000, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Fritel', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Centre Hospitalier Universitaire de Poitiers, 86021, Poitier, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Fauconnier', 'Affiliation': 'EA 7285 Research Unit ""Risk and Safety in Clinical Medicine for Women and Perinatal Health"", Versailles-Saint-Quentin University (UVSQ), 78180, Montigny-le-Bretonneux, France.'}]",International urogynecology journal,['10.1007/s00192-019-03953-6'] 1095,31165950,Efficacy and safety of rivaroxaban on the resolution of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation patients.,"Data on LA/LAA thrombus resolution after rivaroxaban treatment has not been established. The aim of the present study was to compare the efficacy and safety on the resolution of LA/LAA thrombus between rivaroxaban and warfarin in nonvalvular atrial fibrillation (AF) patients. 80 AF patients with LA/LAA thrombus between January 2013 and June 2016 were randomized divided into warfarin group (n = 40) and rivaroxaban group (n = 40). Compared to warfarin group, thrombin time (TT; p < 0.0001), plasma prothrombin time (PT; p < 0.0001), and activated partial thromboplastin time (APTT; p = 0.0019) were significantly lower, and fibrinogen (FIB; p < 0.0001) was significantly higher in rivaroxaban group. TEE shown the average length (p < 0.0001), average width (p = 0.0008) and average area (p < 0.0001) of thrombus were significantly lower in rivaroxaban group compared to warfarin group after 6-week treatments. No major or fatal bleeding and ischemic stroke occurred in both two groups. The 20 mg dose Rivaroxaban is more effective than warfarin on the resolution of LA/LAA thrombus in nonvalvular AF patients especially after 6-week treatments. The results suggest that rivaroxaban is a potential option for the treatment of LA/LAA thrombus in patients with nonvalvular AF.",2019,"Compared to warfarin group, thrombin time (TT; p < 0.0001), plasma prothrombin time (PT; p < 0.0001), and activated partial thromboplastin time (APTT; p = 0.0019) were significantly lower, and fibrinogen (FIB; p < 0.0001) was significantly higher in rivaroxaban group.","['80 AF patients with LA/LAA thrombus between January 2013 and June 2016', 'nonvalvular atrial fibrillation (AF) patients', 'nonvalvular atrial fibrillation patients', 'patients with nonvalvular AF']","['TEE', 'Rivaroxaban', 'rivaroxaban', 'warfarin', 'rivaroxaban and warfarin']","['fatal bleeding and ischemic stroke', 'thrombin time', 'average length', 'plasma prothrombin time', 'activated partial thromboplastin time', 'average width', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0295063,"Compared to warfarin group, thrombin time (TT; p < 0.0001), plasma prothrombin time (PT; p < 0.0001), and activated partial thromboplastin time (APTT; p = 0.0019) were significantly lower, and fibrinogen (FIB; p < 0.0001) was significantly higher in rivaroxaban group.","[{'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Ke', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, China.'}, {'ForeName': 'Xiang-Wei', 'Initials': 'XW', 'LastName': 'Lv', 'Affiliation': ""Department of Cardiology, People's Hospital of Guilin, Guilin, China.""}, {'ForeName': 'En-Hao', 'Initials': 'EH', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, China.'}, {'ForeName': 'Jin-Yi', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, China. 17834968@qq.com.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-019-01876-z'] 1096,31648053,"Regarding: ""The LACC Trial and Minimally Invasive Surgery in Cervical Cancer"".",,2020,,['Cervical Cancer'],[],[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]",[],[],,0.0371369,,"[{'ForeName': 'Philippe R', 'Initials': 'PR', 'LastName': 'Koninckx', 'Affiliation': 'Dubai, United Arab Emirates, Rome, Italy, Leuven, Belgium, and Oxford, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puga', 'Affiliation': 'Santiago, Chile.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ussia', 'Affiliation': 'Rome, Italy.'}, {'ForeName': 'Errico', 'Initials': 'E', 'LastName': 'Zupi', 'Affiliation': 'Siena, Italy.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Keckstein', 'Affiliation': 'Villach, Austria, and Ulm, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Adamian', 'Affiliation': 'Moscow, Russia.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Solima', 'Affiliation': 'Milan, Italy.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Wattiez', 'Affiliation': 'Dubai, United Arab Emirates, and Strasbourg, France.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.10.008'] 1097,31047857,Adherence to multidomain interventions for dementia prevention: Data from the FINGER and MAPT trials.,"INTRODUCTION Multidomain interventions, targeting multiple risk factors simultaneously, could be effective dementia prevention strategies, but may be burdensome and not universally acceptable. METHODS We studied adherence rates and predictors in the Finnish Geriatric Intervevntion Study to Prevent Cognitive Impairment and Disability and Multidomain Alzheimer Preventive Trial prevention trials, for all intervention components (separately and simultaneously). Finnish Geriatric Intervevntion Study to Prevent Cognitive Impairment and Disability participants received a 2-year multidomain lifestyle intervention (physical training, cognitive training, nutritional counseling, and cardiovascular monitoring). Multidomain Alzheimer Preventive Trial participants received a 3-year multidomain lifestyle intervention (cognitive training, physical activity counseling, and nutritional counseling) with either an omega-3 supplement or placebo. RESULTS Adherence decreased with increasing intervention complexity and intensity: it was highest for cardiovascular monitoring, nutritional counseling, and the omega-3 supplement, and lowest for unsupervised computer-based cognitive training. The most consistent baseline predictors of adherence were smoking and depressive symptoms. DISCUSSION Reducing participant burden, while ensuring that technological tools are suitable for older individuals, maintaining face-to-face contacts, and taking into account participant characteristics may increase adherence in future trials.",2019,"RESULTS Adherence decreased with increasing intervention complexity and intensity: it was highest for cardiovascular monitoring, nutritional counseling, and the omega-3 supplement, and lowest for unsupervised computer-based cognitive training.","['dementia prevention', 'Cognitive Impairment and Disability participants']","['multidomain lifestyle intervention (physical training, cognitive training, nutritional counseling, and cardiovascular monitoring', 'multidomain lifestyle intervention (cognitive training, physical activity counseling, and nutritional counseling) with either an omega-3 supplement or placebo', 'multidomain interventions']",[],"[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0161959', 'cui_str': 'Cardiovascular monitoring (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.026668,"RESULTS Adherence decreased with increasing intervention complexity and intensity: it was highest for cardiovascular monitoring, nutritional counseling, and the omega-3 supplement, and lowest for unsupervised computer-based cognitive training.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Coley', 'Affiliation': 'INSERM-University of Toulouse UMR 1027, Toulouse, France; Department of Epidemiology and Public Health, Toulouse University Hospital, Toulouse, France. Electronic address: nicola.coley@inserm.fr.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Department of Public Health Solutions, Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Lehtisalo', 'Affiliation': 'Department of Public Health Solutions, Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland; Department of Public Health, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Neurocenter, Neurology, Kuopio University Hospital, Kuopio, Finland; Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'INSERM-University of Toulouse UMR 1027, Toulouse, France; Gerontopole, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Edo', 'Initials': 'E', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Neurology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Department of Public Health Solutions, Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden; Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'INSERM-University of Toulouse UMR 1027, Toulouse, France; Department of Epidemiology and Public Health, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1016/j.jalz.2019.03.005'] 1098,31740114,Early outcomes with durable left ventricular assist device replacement using the HeartMate 3.,"BACKGROUND The HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement. METHODS An institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery. RESULTS There was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3. CONCLUSIONS LVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement.",2020,"The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P ","['19 consecutive patients who underwent', 'patients with chronic heart failure', 'group 1) versus 85 consecutive control patients who underwent', 'patients requiring LVAD replacement', 'Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3']","['pump replacement to HM3', 'Ventricular Assist Device', 'durable left ventricular assist device replacement', 'pump replacement to either Heartmate II or HeartWare', 'HeartMate 3 (HM3) left ventricular assist device (LVAD']","['number of previous sternotomies', 'composite of freedom from death or need for another replacement surgery', 'body mass index', 'greater number of previous LVAD implants', 'freedom from either death or need for another replacement', 'thrombosis events', 'postoperative adverse event rates', 'heart failure etiology']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0015127', 'cui_str': 'causes'}]",19.0,0.051187,"The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P ","[{'ForeName': 'Yaron D', 'Initials': 'YD', 'LastName': 'Barac', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC. Electronic address: yaronbar@icloud.com.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Wojnarski', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Parichart', 'Initials': 'P', 'LastName': 'Junpaparp', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Billard', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Mani A', 'Initials': 'MA', 'LastName': 'Daneshmand', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agrawal', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Devore', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Jacob N', 'Initials': 'JN', 'LastName': 'Schroder', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Carmelo A', 'Initials': 'CA', 'LastName': 'Milano', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.151'] 1099,31074333,Design and analysis of stratified clinical trials in the presence of bias.,"BACKGROUND Among various design aspects, the choice of randomization procedure have to be agreed on, when planning a clinical trial stratified by center. The aim of the paper is to present a methodological approach to evaluate whether a randomization procedure mitigates the impact of bias on the test decision in clinical trial stratified by center. METHODS We use the weighted t test to analyze the data from a clinical trial stratified by center with a two-arm parallel group design, an intended 1:1 allocation ratio, aiming to prove a superiority hypothesis with a continuous normal endpoint without interim analysis and no adaptation in the randomization process. The derivation is based on the weighted t test under misclassification, i.e. ignoring bias. An additive bias model combing selection bias and time-trend bias is linked to different stratified randomization procedures. RESULTS Various aspects to formulate stratified versions of randomization procedures are discussed. A formula for sample size calculation of the weighted t test is derived and used to specify the tolerated imbalance allowed by some randomization procedures. The distribution of the weighted t test under misclassification is deduced, taking the sequence of patient allocation to treatment, i.e. the randomization sequence into account. An additive bias model combining selection bias and time-trend bias at strata level linked to the applied randomization sequence is proposed. With these before mentioned components, the potential impact of bias on the type one error probability depending on the selected randomization sequence and thus the randomization procedure is formally derived and exemplarily calculated within a numerical evaluation study. CONCLUSION The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design. It enables the choice of the best practice procedure. The evaluation stimulates the discussion about the level of evidence resulting in those kind of clinical trials.",2020,The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design.,[],[],['tolerated imbalance'],[],[],[],,0.0810538,The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design.,"[{'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Manolov', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heussen', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Statistics, George Mason University, Fairfax, VA, USA.'}]",Statistical methods in medical research,['10.1177/0962280219846146'] 1100,31759193,In pursuit of a sensitive EEG functional connectivity outcome measure for clinical trials in Alzheimer's disease.,"OBJECTIVE In clinical trials in Alzheimer's Disease (AD), an improvement of impaired functional connectivity (FC) could provide biological support for the potential efficacy of the drug. Electroencephalography (EEG) analysis of the SAPHIR-trial showed a treatment induced improvement of global relative theta power but not of FC measured by the phase lag index (PLI). We compared the PLI with the amplitude envelope correlation with leakage correction (AEC-c), a presumably more sensitive FC measure. METHODS Patients with early AD underwent 12 weeks of placebo or treatment with PQ912, a glutaminylcyclase inhibitor. Eyes-closed task free EEG was measured at baseline and follow-up (PQ912 n = 47, placebo n = 56). AEC-c and PLI were measured in multiple frequency bands. Change in FC was compared between treatment groups by using two models of covariates. RESULTS A significant increase in global AEC-c in the alpha frequency band was found with PQ912 treatment compared to placebo (p = 0.004, Cohen's d = 0.58). The effect remained significant when corrected for sex, country, ApoE ε4 carriage, age, baseline value (model 1; p = 0.006) and change in relative alpha power (model 2; p = 0.004). CONCLUSIONS Functional connectivity in early AD, measured with AEC-c in the alpha frequency band, improved after PQ912 treatment. SIGNIFICANCE AEC-c may be a robust and sensitive FC measure for detecting treatment effects.",2020,"A significant increase in global AEC-c in the alpha frequency band was found with PQ912 treatment compared to placebo (p = 0.004,","[""Alzheimer's Disease (AD"", ""Alzheimer's disease"", 'Patients with early AD underwent 12\u202fweeks of']","['placebo or treatment with PQ912, a glutaminylcyclase inhibitor', 'placebo']","['global AEC-c', 'Eyes-closed task free EEG', 'AEC-c and PLI', 'Change in FC']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0711372,"A significant increase in global AEC-c in the alpha frequency band was found with PQ912 treatment compared to placebo (p = 0.004,","[{'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Briels', 'Affiliation': 'Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands; Department of Clinical Neurophysiology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands. Electronic address: c.briels@vumc.nl.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Stam', 'Affiliation': 'Department of Clinical Neurophysiology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Scheltens', 'Affiliation': 'Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bruins', 'Affiliation': 'Probiodrug AG, Halle, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Lues', 'Affiliation': 'Probiodrug AG, Halle, Germany.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Gouw', 'Affiliation': 'Department of Clinical Neurophysiology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2019.09.014'] 1101,31111151,Statin therapy increases lipoprotein(a) levels.,"AIMS Lipoprotein(a) [Lp(a)] is elevated in 20-30% of people. This study aimed to assess the effect of statins on Lp(a) levels. METHODS AND RESULTS This subject-level meta-analysis includes 5256 patients (1371 on placebo and 3885 on statin) from six randomized trials, three statin-vs.-placebo trials, and three statin-vs.-statin trials, with pre- and on-treatment (4-104 weeks) Lp(a) levels. Statins included atorvastatin 10 mg/day and 80 mg/day, pravastatin 40 mg/day, rosuvastatin 40 mg/day, and pitavastatin 2 mg/day. Lipoprotein(a) levels were measured with the same validated assay. The primary analysis of Lp(a) is based on the log-transformed data. In the statin-vs.-placebo pooled analysis, the ratio of geometric means [95% confidence interval (CI)] for statin to placebo is 1.11 (1.07-1.14) (P < 0.0001), with ratio >1 indicating a higher increase in Lp(a) from baseline in statin vs. placebo. The mean percent change from baseline ranged from 8.5% to 19.6% in the statin groups and -0.4% to -2.3% in the placebo groups. In the statin-vs.-statin pooled analysis, the ratio of geometric means (95% CI) for atorvastatin to pravastatin is 1.09 (1.05-1.14) (P < 0.0001). The mean percent change from baseline ranged from 11.6% to 20.4% in the pravastatin group and 18.7% to 24.2% in the atorvastatin group. Incubation of HepG2 hepatocytes with atorvastatin showed an increase in expression of LPA mRNA and apolipoprotein(a) protein. CONCLUSION This meta-analysis reveals that statins significantly increase plasma Lp(a) levels. Elevations of Lp(a) post-statin therapy should be studied for effects on residual cardiovascular risk.",2020,"Incubation of HepG2 hepatocytes with atorvastatin showed an increase in expression of LPA mRNA and apolipoprotein(a) protein. ","['20-30% of people', '5256 patients (1371 on placebo and 3885 on statin) from six randomized trials, three']","['statin-vs.-placebo', 'placebo', 'pravastatin', 'atorvastatin', 'pravastatin 40\u2009mg/day, rosuvastatin 40\u2009mg/day, and pitavastatin', 'Lipoprotein(a) [Lp(a']","['ratio of geometric means', 'lipoprotein(a) levels', 'Lipoprotein(a) levels', 'Lp(a', 'expression of LPA mRNA and apolipoprotein(a) protein', 'plasma Lp(a) levels', 'Lp(a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.303257,"Incubation of HepG2 hepatocytes with atorvastatin showed an increase in expression of LPA mRNA and apolipoprotein(a) protein. ","[{'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Vascular Medicine Program, Sulpizio Cardiovascular Center, Division of Cardiovascular Diseases, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0682, USA.'}, {'ForeName': 'Philip L S M', 'Initials': 'PLSM', 'LastName': 'Gordts', 'Affiliation': 'Department of Cellular and Molecular Medicine, Glycobiology Research and Training Center, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0682, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Nora', 'Affiliation': 'Department of Cellular and Molecular Medicine, Glycobiology Research and Training Center, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0682, USA.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Yeang', 'Affiliation': 'Vascular Medicine Program, Sulpizio Cardiovascular Center, Division of Cardiovascular Diseases, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0682, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolism, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0682, USA.'}]",European heart journal,['10.1093/eurheartj/ehz310'] 1102,31638341,TheraP: a randomized phase 2 trial of 177 Lu-PSMA-617 theranostic treatment vs cabazitaxel in progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603).,"OBJECTIVE To assess the activity and safety of cabazitaxel chemotherapy vs that of treatment with 177 Lu-PSMA-617, a novel radiolabelled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), in men with metastatic castration-resistant prostate cancer (mCRPC) who have received prior docetaxel treatment. PATIENTS AND METHODS The TheraP trial (ANZUP 1603) is an open-label, randomized, stratified, two-arm multicentre phase 2 trial comparing the activity and safety of cabazitaxel chemotherapy vs 177 Lu-PSMA-617 therapy in the treatment of men with mCRPC. Key eligibility criteria include prior docetaxel chemotherapy, rising prostate-specific antigen (PSA) level, sufficient PSMA avidity, as defined by centrally reviewed 68 Ga-PSMA-11 and fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) with no discordant FDG-avid PSMA-negative sites of disease. Patients in the control group receive standard treatment with cabazitaxel (20 mg/m 2 ) i.v. every 3 weeks with prednisolone 10 mg daily orally, for a maximum of 10 cycles. Patients in the experimental group receive 177 Lu-PSMA-617 (8.5 GBq decreasing by 0.5 GBq per cycle) i.v. every 6 weeks, for up to a maximum of six cycles. In the event of an exceptional response as defined on centrally reviewed post-therapy single-photon emission CT imaging, treatment will be suspended but can recommence on progression. The trial aims to include 200 patients who will be centrally randomized to one of the two treatment groups, in a 1:1 ratio. The primary endpoint is PSA response. Secondary endpoints are overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events. The treatment and outcomes of patients excluded on the basis of low PSMA avidity or discordant FDG-avid disease on screening 68 Ga-PSMA-11 and Fluorine-18 ( 18 F)-FDG-PET/CT scan will also be assessed. Enrolment in the study commenced on 29 January 2018. RESULTS AND CONCLUSIONS 177 Lu-PSMA-617 offers a potential additional life-prolonging treatment option for men with mCRPC. The results of this trial will determine, for the first time in a randomized design, the activity and safety of 177 Lu-PSMA-617, as compared with cabazitaxel chemotherapy in men with progressive mCRPC.",2019,"Secondary endpoints are overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events.","['men with mCRPC', '200 patients who will be centrally randomized to one of the two treatment groups, in a 1:1 ratio', 'progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603', 'men with progressive mCRPC', '29 January 2018', 'men with metastatic castration-resistant prostate cancer (mCRPC) who have received prior docetaxel treatment', 'patients excluded on the basis of low PSMA avidity or discordant FDG-avid disease on screening 68 Ga-PSMA-11 and Fluorine-18 ( 18']","['prednisolone', 'F)-FDG-PET/CT scan', 'cabazitaxel', 'cabazitaxel chemotherapy vs 177 Lu-PSMA-617 therapy', 'TheraP', 'fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT', 'Lu-PSMA-617 theranostic treatment vs cabazitaxel', 'cabazitaxel chemotherapy']","['activity and safety', 'PSA response', 'overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C2599718', 'cui_str': 'Trial Protocols'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C4078835', 'cui_str': 'PSMA-617'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C4046052', 'cui_str': 'Theranostics'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.185373,"Secondary endpoints are overall survival, progression-free survival (PFS), radiographic PFS, PSA PFS, objective tumour response, pain response, pain PFS, health-related quality of life, and frequency and severity of adverse events.","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Emmett', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Violet', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Y Zhang', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Lawrence', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stockler', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Roslyn J', 'Initials': 'RJ', 'LastName': 'Francis', 'Affiliation': 'Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Iravani', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Azad', 'Affiliation': 'Peter MacCallum Cancer Centre, and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McJannett', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}]",BJU international,['10.1111/bju.14876'] 1103,31057807,A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial.,"Background Family carepartner management and support can improve stroke survivor recovery, yet research has placed little emphasis on how to integrate families into the rehabilitation process without increasing negative carepartner outcomes. Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor. The purpose of this study is to explore a novel, web-based intervention (Carepartner and Constraint-Induced Therapy; CARE-CITE) designed to facilitate positive carepartner involvement during a home-based application of constraint-induced movement therapy (CIMT) for the upper extremity. Methods The primary aim of the study is to determine feasibility of CARE-CITE for both stroke survivors and their carepartners. Carepartner mental health, family conflict surrounding stroke recovery, and stroke survivor upper extremity function will be evaluated using an evaluator blinded, two-group experimental design (blocked randomization protocol according to a 2:1 randomization schema) with 32 intervention dyads and 16 control dyads (who will receive CIMT without structured carepartner involvement). CARE-CITE consists of online education modules for the carepartner to review in parallel to the 30-h CIMT that the stroke survivor receives. The intent of CARE-CITE is to enhance the home-based intervention of CIMT, by helping the carepartner support the therapy and create a therapeutic home environment encouraging practice of the weaker arm in functional tasks. Discussion The CARE-CITE study is testing the feasibility of a family-integrated rehabilitation approach applied in the home environment, and results will provide the foundation for larger clinical studies. The overall significance of this research plan is to increase the understanding and further development of interventions that may serve as models to promote family involvement in the rehabilitation process. Trial registration ClinicalTrials.gov, NCT02703532. Registered 9 March 2016.",2019,Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor.,['persons with stroke'],"['constraint-induced movement therapy (CIMT', 'web-based intervention (Carepartner and Constraint-Induced Therapy; CARE-CITE', 'A web-based carepartner-integrated rehabilitation program', 'CARE-CITE']",[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0350999,Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blanton', 'Affiliation': '1Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, 1441 Clifton Road NE, Room 213, Atlanta, GA 30322 USA.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Clark', 'Affiliation': '2Byrdine F. Lewis School of Nursing, Georgia State University, Atlanta, GA USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lyles', 'Affiliation': '3Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, 1518 Clifton Road, NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': '3Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, 1518 Clifton Road, NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Jones', 'Affiliation': '4Interactive Media Technology Center, Georgia Institute of Technology, 85 Fifth Street Northwest, Atlanta, GA 30308 USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Reiss', 'Affiliation': '5Emory University School of Medicine, 1441 Clifton Road NE, Room 206, Atlanta, GA 30322 USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Wolf', 'Affiliation': '1Division of Physical Therapy, Department of Rehabilitation Medicine, Emory University School of Medicine, 1441 Clifton Road NE, Room 213, Atlanta, GA 30322 USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dunbar', 'Affiliation': '7Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Road, NE, Atlanta, GA 30322 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-019-0439-0'] 1104,31055222,An omega-3 fatty acid plasma index ≥4% prevents progression of coronary artery plaque in patients with coronary artery disease on statin treatment.,"BACKGROUND AND AIMS Higher blood levels of the omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have been associated with fewer cardiovascular events and lower mortality in prospective studies. Our aim was to determine a target level of EPA and DHA to prevent progression of coronary artery plaque. METHODS 218 subjects with stable coronary artery disease on statins were randomized to high-dose EPA and DHA (3.36 g daily) or no omega-3 for 30 months. Coronary plaque volume was measured by coronary computed tomographic angiography. Plasma phospholipid levels of EPA, DHA and total fatty acids were measured by gas chromatography mass spectrometry. The omega-3 fatty acid index was calculated as EPA+DHA/total fatty acid. RESULTS Mean (SD) age was 62.9 (7.8) years; mean (SD) LDL-C level 78.6 (27.3) mg/dL and median triglyceride level 122 mg/dL. Subjects assigned to EPA and DHA had increased plasma EPA and DHA levels variably from 1.85% to 13.02%. Plasma omega-3 fatty acid index ≥4% prevented progression of fibrous, noncalcified, calcified and total plaque in nondiabetic subjects whereas those in the lowest quartile (<3.43%) had significant progression of fibrous, calcified and total plaque. No difference was observed in diabetic subjects. CONCLUSIONS EPA and DHA added to statins prevented coronary plaque progression in nondiabetic subjects with mean LDL-C <80 mg/dL, when an omega-3 index ≥4% was achieved. Low omega-3 index <3.43% identified nondiabetic subjects at risk of coronary plaque progression despite statin therapy. These findings highlight the importance of measuring plasma levels of omega-3 fatty acids early and at trial conclusion. Targeting an omega-3 index ≥4% maximizes cardiovascular benefit.",2019,"Plasma omega-3 fatty acid index ≥4% prevented progression of fibrous, noncalcified, calcified and total plaque in nondiabetic subjects whereas those in the lowest quartile (<3.43%) had significant progression of fibrous, calcified and total plaque.","['218 subjects with stable coronary artery disease on statins were randomized to high-dose EPA and DHA (3.36', 'patients with coronary artery disease on statin treatment', 'nondiabetic subjects']","['no omega-3', 'EPA and DHA', 'omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['Coronary plaque volume', 'diabetic subjects', 'Plasma omega-3 fatty acid index ≥4% prevented progression of fibrous, noncalcified, calcified and total plaque', 'plasma EPA and DHA levels', 'Mean (SD) age', 'coronary plaque progression', 'omega-3 fatty acid index', 'Plasma phospholipid levels of EPA, DHA and total fatty acids']","[{'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439709', 'cui_str': 'Fibrous (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]",218.0,0.0245803,"Plasma omega-3 fatty acid index ≥4% prevented progression of fibrous, noncalcified, calcified and total plaque in nondiabetic subjects whereas those in the lowest quartile (<3.43%) had significant progression of fibrous, calcified and total plaque.","[{'ForeName': 'Abdulhamied', 'Initials': 'A', 'LastName': 'Alfaddagh', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Tarec K', 'Initials': 'TK', 'LastName': 'Elajami', 'Affiliation': 'Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Saleh', 'Affiliation': 'Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Donya', 'Initials': 'D', 'LastName': 'Mohebali', 'Affiliation': 'Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Bistrian', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Francine K', 'Initials': 'FK', 'LastName': 'Welty', 'Affiliation': 'Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA. Electronic address: fwelty@bidmc.harvard.edu.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2019.04.213'] 1105,31743542,"Effect of a sphingolipid-mimetic compound on the promotion of hair growth: A randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND Pattern hair loss is a very common skin disorder, but more therapeutic modalities for hair growth are still required. OBJECTIVE We investigated the effect of a newly synthesized sphingolipid-mimetic compound (pseudo-ceramide: bis-oleamide isopropyl alcohol [BOI]) on the promotion of hair growth for patients with mild pattern hair loss. METHODS A total of 58 patients with mild pattern hair loss participated in this clinical trial. A randomized, double-blind, placebo-controlled clinical trial was conducted for 6 months. Participants in the experimental group applied 1% BOI lotion (ceramide HS) on the whole scalp once a day for 6 months. Participants in the control group applied simulacrum using the same protocol. We evaluated daily hair loss, hair density, hair thickness, and hair length at intervals of 3 months; patient satisfaction and adverse events were evaluated at 6 months. RESULTS At 6 months in the experimental group, daily hair loss at baseline (52.52 ± 33.98) decreased to 40.41 ± 24.78, vertex hair density at baseline (131.07 ± 43.73) increased to 156.00 ± 39.59, frontal hair density at baseline (104.21 ± 30.72) increased to 124.10 ± 28.28, thickness of vertex hair at baseline (0.067 ± 0.012 cm) increased to 0.075 ± 0.014 cm, thickness of frontal hair at baseline (0.070 ± 0.009 cm) increased to 0.076 ± 0.012 cm, and hair growth rate was 16.17 ± 1.89 mm/month. CONCLUSION Ceramide HS may be a new candidate for the treatment of pattern hair loss.",2020,"At 6 months in the experimental group, daily hair loss at baseline (52.52 ± 33.98) decreased to 40.41 ± 24.78, vertex hair density at baseline (131.07 ± 43.73) increased to 156.00 ± 39.59, frontal hair density at baseline (104.21 ± 30.72) increased to 124.10 ± 28.28, thickness of vertex hair at baseline (0.067 ± 0.012 cm) increased to 0.075 ± 0.014 cm, thickness of frontal hair at baseline (0.070 ± 0.009 cm) increased to 0.076 ± 0.012 cm, and hair growth rate was 16.17 ± ","['58 patients with mild pattern hair loss participated in this clinical trial', 'patients with mild pattern hair loss']","['placebo', 'newly synthesized sphingolipid-mimetic compound (pseudo-ceramide: bis-oleamide isopropyl alcohol [BOI', 'BOI lotion (ceramide HS', 'sphingolipid-mimetic compound']","['hair growth rate', 'daily hair loss, hair density, hair thickness, and hair length at intervals of 3\xa0months; patient satisfaction and adverse events', 'vertex hair density', 'thickness of vertex hair', 'thickness of frontal hair', 'daily hair loss', 'frontal hair density', 'promotion of hair growth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037900', 'cui_str': 'Sphingolipids'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0377344', 'cui_str': 'oleylamide'}, {'cui': 'C0022237', 'cui_str': 'rubbing alcohol'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}]","[{'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",58.0,0.410382,"At 6 months in the experimental group, daily hair loss at baseline (52.52 ± 33.98) decreased to 40.41 ± 24.78, vertex hair density at baseline (131.07 ± 43.73) increased to 156.00 ± 39.59, frontal hair density at baseline (104.21 ± 30.72) increased to 124.10 ± 28.28, thickness of vertex hair at baseline (0.067 ± 0.012 cm) increased to 0.075 ± 0.014 cm, thickness of frontal hair at baseline (0.070 ± 0.009 cm) increased to 0.076 ± 0.012 cm, and hair growth rate was 16.17 ± ","[{'ForeName': 'Weon Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Chihyeon', 'Initials': 'C', 'LastName': 'Sohng', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Kyung Duck', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Jang', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Seok-Jong', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13220'] 1106,31712086,Neurophysiological aftereffects of 10 Hz and 20 Hz transcranial alternating current stimulation over bilateral sensorimotor cortex.,"Alpha (8-12 Hz) and beta (13-30 Hz) oscillations are believed to be involved in motor control. Their modulation with transcranial alternating current stimulation (tACS) has been shown to alter motor behavior and cortical excitability. The aim of the present study was to determine whether tACS applied bilaterally over sensorimotor cortex at 10 Hz and 20 Hz modulates interhemispheric interactions and corticospinal excitability. Thirty healthy volunteers participated in a randomized, cross-over, sham-controlled, double-blind protocol. Sham and active tACS (10 Hz, 20 Hz, 1 mA) were applied for 20 min over bilateral sensorimotor areas. The physiological effects of tACS on corticospinal excitability and interhemispheric inhibition were assessed with transcranial magnetic stimulation. Physiological mirror movements were assessed to measure the overflow of motor activity to the contralateral M1 during voluntary muscle contraction. Bilateral 10 Hz tACS reduced corticospinal excitability. There was no significant effect of tACS on physiological mirror movements and interhemispheric inhibition. Ten Hz tACS was associated with response patterns consistent with corticospinal inhibition in 57% of participants. The present results indicate that application of tACS at the alpha frequency can induce aftereffects in sensorimotor cortex of healthy individuals.",2020,There was no significant effect of tACS on physiological mirror movements and interhemispheric inhibition.,"['Thirty healthy volunteers', 'Bilateral 10']","['Hz tACS', 'tACS', 'Sham and active tACS (10Hz, 20 Hz, 1 mA', '10 Hz and 20 Hz transcranial alternating current stimulation', 'transcranial alternating current stimulation (tACS']","['physiological mirror movements and interhemispheric inhibition', 'corticospinal excitability and interhemispheric inhibition', 'corticospinal excitability']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1172076', 'cui_str': '1-(PE)-MA'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0454455', 'cui_str': 'Mirror movements'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",30.0,0.167692,There was no significant effect of tACS on physiological mirror movements and interhemispheric inhibition.,"[{'ForeName': 'Louis-Philippe', 'Initials': 'LP', 'LastName': 'Lafleur', 'Affiliation': 'Department of psychologie, Université de Montréal, Montréal, Canada; Centre de recherche du Centre Hospitalier Universitaire Sainte-Justine, Montréal, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Klees-Themens', 'Affiliation': 'Department of psychologie, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chouinard-Leclaire', 'Affiliation': 'Department of psychologie, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Larochelle-Brunet', 'Affiliation': 'Department of psychologie, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tremblay', 'Affiliation': 'Department of Psychology, Carleton University, Ottawa, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Lepage', 'Affiliation': 'Département de Pédiatrie, Médecine nucléaire et radiobiologie, Centre de recherche du CHU Sherbrooke, Sherbrooke, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Théoret', 'Affiliation': 'Department of psychologie, Université de Montréal, Montréal, Canada; Centre de recherche du Centre Hospitalier Universitaire Sainte-Justine, Montréal, Canada. Electronic address: hugo.theoret@umontreal.ca.'}]",Brain research,['10.1016/j.brainres.2019.146542'] 1107,31081030,The relationship between an electronic mental health stigma campaign and suicidal thoughts and behaviours: a two-arm randomized controlled trial in the Australian construction industry.,"Males employed in the construction industry are at greater risk of suicide than other employed males. It is plausible that a high level of stigma against mental health problems explains the elevated rates of suicide among this group. This study sought to test the effectiveness of an electronic mental health stigma intervention on suicide ideation, communication about suicide and attempts. Participants were randomly assigned to receive either a series of brief contact interventions over a 6-week period or a wait list control. Suicidal ideation, communication about suicide and suicide attempts were assessed using the Suicidal Behaviors Questionnaire-Revised at post-intervention. We used linear regression to assess effectiveness at post-intervention, adjusting for relevant covariates using both conventional methods and a propensity score approach. Results indicate that the intervention had no significant impact on suicidal thoughts, communication or suicide attempts. There was some indication that individuals in the intervention group reported a slight increase in attempts and communication about suicide. These observations underscore an urgent need for more research to understand the complex and nuanced relationship between stigma and suicide in non-clinical populations.",2020,"Suicidal ideation, communication about suicide and suicide attempts were assessed using the Suicidal Behaviors Questionnaire-Revised at post-intervention.",[],"['brief contact interventions over a 6-week period or a wait list control', 'electronic mental health stigma intervention']","['Suicidal ideation, communication about suicide and suicide attempts', 'attempts and communication about suicide', 'suicidal thoughts, communication or suicide attempts', 'Suicidal Behaviors Questionnaire-Revised']",[],"[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0821599,"Suicidal ideation, communication about suicide and suicide attempts were assessed using the Suicidal Behaviors Questionnaire-Revised at post-intervention.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Milner', 'Affiliation': 'Melbourne School of Population and Global Health, Centre for Health Equity, University of Melbourne, Australia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Aitken', 'Affiliation': 'Melbourne School of Population and Global Health, Centre for Health Equity, University of Melbourne, Australia.'}, {'ForeName': 'P C F', 'Initials': 'PCF', 'LastName': 'Law', 'Affiliation': 'Melbourne School of Population and Global Health, Centre for Health Equity, University of Melbourne, Australia.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'LaMontagne', 'Affiliation': 'School of Health and Social Development, Centre for Population Health Research, Deakin University, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mann', 'Affiliation': 'Incolink - Victoria, 1 Pelham Street, Carlton, VIC 3053, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cooper', 'Affiliation': 'Incolink - Victoria, 1 Pelham Street, Carlton, VIC 3053, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Witt', 'Affiliation': 'Turning Point, Eastern Health Clinical School, Monash University, Australia.'}]",Health promotion international,['10.1093/heapro/daz034'] 1108,31735613,"A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial.","INTRODUCTION There are only a few studies on the clinical utility of filler injections for penile augmentation (PA) in patients with small penis syndrome (SPS), which is a type of anxiety or body dysmorphic disorder, not a true micropenis. AIM To compare the clinical outcomes of hyaluronic acid (HA) with polylactic acid (PLA) filler injection for temporary PA in patients with SPS. METHODS Our prospective, patient/evaluator-blind, comparative, randomized, non-inferiority trial consisted of a single filler injection and a 24-week post-injection period. Seventy-four men with SPS were included between November 2017 and February 2018. Patients were divided into those injected with HA (n = 39) and those injected with PLA filler (n = 35). MAIN OUTCOME MEASURE The psychological effects of PA, based on the Beliefs about Penis Size Scale, penile girth, and satisfaction, were assessed at baseline and at 4, 12, and 24 weeks post-injection. RESULTS At 24 weeks, the mean penile girth increases were 2.1 ± 1.0 cm (P < .001) in the HA group and 1.6 ± 0.9 cm (P < .001) in the PLA group, with a mean difference of 0.5 ± 0.2 cm between groups (P = .031). In both groups, satisfaction levels significantly increased at 24 weeks, with 1.8 ± 1.7 and 1.6 ± 1.4 mean increases in the visual analog scale for penile appearance satisfaction in the HA and PLA groups, respectively (each P < .001), and 1.0 ± 1.1 and 0.7 ± 1.2 mean increases in the visual analog scale for sexual life satisfaction in the HA and PLA groups, respectively (each P < .001), with no significant differences between groups (P = .950 and P = .287). The mean Beliefs about Penis Size Scale scores significantly decreased at 24 weeks, with 7.8 ± 8.3 and 5.3 ± 7.2 mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920). There were no serious adverse events, but filler injection-related adverse events in the HA and the PLA groups were reported in 2 cases (5.13%) and 5 cases (14.29%), respectively (P = .245). CLINICAL IMPLICATIONS Our study provides an overview of clinical course after HA and PLA filler injections for PA and suggests that filler injections can be considered an alternative approach in patients with SPS. STRENGTHS & LIMITATIONS Our study is the first to assess the psychological symptoms in patients with SPS who received the filler injection for PA; however, the follow-up duration was insufficient to prove the long-term outcomes of fillers. CONCLUSION Without serious adverse events, HA and PLA filler injections for PA significantly resulted in not only an augmentative effect but also improvement of psychological distress, and the clinical utility was comparable between the fillers. Yang DY, Jeong HC, Ahn ST, et al. A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial. J Sex Med 2020;17:133-141.",2020,"mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920).","['patients with small penis syndrome (SPS', 'patients with SPS', 'Patients with Small Penis Syndrome', 'patients with SPS who received the', 'Seventy-four men with SPS were included between November 2017 and February 2018']","['filler injection for PA', 'Hyaluronic Acid and Polylactic Acid Filler Injections', 'PLA filler', 'hyaluronic acid (HA) with polylactic acid (PLA) filler injection']","['mean penile girth increases', 'Beliefs about Penis Size Scale, penile girth, and satisfaction', 'psychological distress', 'psychological symptoms', 'clinical utility', 'satisfaction levels', 'filler injection-related adverse events', 'visual analog scale for penile appearance satisfaction', 'visual analog scale for sexual life satisfaction', 'serious adverse events', 'mean Beliefs about Penis Size Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0240701', 'cui_str': 'Small penis (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0071443', 'cui_str': 'poly(lactic acid)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0426331', 'cui_str': 'Penis size'}, {'cui': 'C0222045'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",74.0,0.0414166,"mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920).","[{'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Chuncheon, Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Chuncheon, Korea.'}, {'ForeName': 'Sun Tae', 'Initials': 'ST', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Woong Jin', 'Initials': 'WJ', 'LastName': 'Bae', 'Affiliation': 'Department of Urology, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Du Geon', 'Initials': 'DG', 'LastName': 'Moon', 'Affiliation': 'Department of Urology, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Sae Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Chuncheon, Korea. Electronic address: rheewk@hanmail.net.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.006'] 1109,31053180,Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis.,"Background: GSP301 is an investigational fixed-dose combination nasal spray that contains the antihistamine, olopatadine hydrochloride (HCl), and the corticosteroid, mometasone furoate. Objective: To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). Methods: In this double-blind, randomized, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to intranasal GSP301 (olopatadine 665 μg and mometasone 25 μg), olopatadine HCl (665 μg), mometasone furoate (25 μg), or placebo for 14 days of twice-daily treatment. The primary end point was the mean change from baseline in the average A.M. and P.M. 12-hour reflective Total Nasal Symptom Score (rTNSS) analyzed by using mixed-effect model repeated measures ( p < 0.05 indicates statistical significance). Additional assessments included instantaneous TNSS (iTNSS), individual nasal symptoms, reflective Total Ocular Symptom Score (rTOSS) and instantaneous Total Ocular Symptom Score (iTOSS), onset of action, Physician-assessed Nasal Symptom Score (PNSS), quality of life, and adverse events (AE). Results: A total of 1180 patients were randomized. Over 14 days of treatment, GSP301 significantly improved average A.M. and P.M. rTNSS versus placebo (least squares mean difference -0.98 [95% confidence interval, -1.38 to -0.57]; p < 0.001) and versus olopatadine (p = 0.003), and approached statistical significance versus mometasone (p = 0.059). GSP301 also significantly improved average A.M. and P.M. iTNSS versus placebo and both monotherapies (p < 0.05, all). Further, GSP301 significantly improved individual nasal symptoms, overall ocular symptoms (rTOSS and iTOSS), and overall quality of life versus placebo (p < 0.01, all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent time points assessed. Results for the PNSS also were significant for GSP301 versus placebo (p < 0.001). The percentages of patients with treatment-emergent AEs treated with GSP301, olopatadine, mometasone, and placebo were 12.9, 12.5, 7.1, and 9.4%, respectively. Conclusion: GSP301 was efficacious and well tolerated for the treatment of SAR symptoms compared with placebo, with a rapid onset of action of 15 minutes in patients ≥12 years of age.Clinical trial NCT02631551, www.clinicaltrials.gov.",2019,"GSP301 also significantly improved average A.M. and P.M. iTNSS versus placebo and both monotherapies (p < 0.05, all).","['patients with seasonal allergic rhinitis (SAR', 'patients with seasonal allergic rhinitis', 'patients (≥12 years of age) with SAR', '1180 patients were randomized']","[' ext-link-type=""uri"" xlink', 'corticosteroid, mometasone furoate', 'mometasone', 'intranasal GSP301 (olopatadine 665 μg and mometasone 25 μg), olopatadine HCl (665 μg), mometasone furoate (25 μg), or placebo', 'placebo', 'antihistamine, olopatadine hydrochloride (HCl', 'GSP301, olopatadine, mometasone, and placebo', 'href=""http://www.clinicaltrials.gov"">www.clinicaltrials.gov50%) after LSG or RYGB; the second primary outcome was defined as a composite endpoint of at least one major complication. Secondary objectives were regression of comorbidities and improvement in quality of life. RESULTS Two hundred and seventy-seven patients were included (91 RYGBP, 186 LSG). The mean age was 41.1±11.1 years, and average preoperative body mass index of 45.3±5.5kg/m 2 . After 36months, the %EWL>50% was not inferior in the case of LSG (82.2%) relative to LRYGB (82.1%); while major complications rates were significantly higher in LRYGB (15.4%) vs. LSG (5.4%, P=0.005). After 36months, all secondary objectives were comparable between groups while only gastroesophageal reflux disease (GERD) increased in LSG group and decreased in LRYGB group. CONCLUSIONS LSG was found non-inferior to LRYGB with respect to weight loss and was associated with lower risk of major complications during a 3-year follow-up. But GERD increased in LSG group and decreased in LRYGB group.",2019,"CONCLUSIONS LSG was found non-inferior to LRYGB with respect to weight loss and was associated with lower risk of major complications during a 3-year follow-up.","['University hospital and bariatric surgery centers, France', 'Two hundred and seventy-seven patients were included (91 RYGBP, 186 LSG', '277 patients, 3 years follow-up']","['Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en Y gastric bypass (LRYGB', 'LSG and RYGBP', 'sleeve gastrectomy and Roux-en-Y gastric bypass']","['But GERD', 'gastroesophageal reflux disease (GERD', 'joint hypothesis during the 36-month follow-up: the first primary outcome pertained to the frequency of patients with an excess weight loss (EWL', 'quality of life', 'weight loss and morbimortality', 'composite endpoint of at least one major complication', 'major complications rates']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0034380'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",277.0,0.0268406,"CONCLUSIONS LSG was found non-inferior to LRYGB with respect to weight loss and was associated with lower risk of major complications during a 3-year follow-up.","[{'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Catheline', 'Affiliation': 'Department of digestive surgery, centre hospitalier de Saint-Denis, 2, rue du Docteur-Delafontaine, 93205 Saint-Denis, France. Electronic address: jmcatheline@orange.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fysekidis', 'Affiliation': 'Department of endocrinology, hôpital Avicenne, AP-HP, 125, rue de Stalingrad, 93000 Bobigny, France. Electronic address: fisekidis_marinos@hotmail.com.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bendacha', 'Affiliation': 'Department of digestive surgery, centre hospitalier de Saint-Denis, 2, rue du Docteur-Delafontaine, 93205 Saint-Denis, France. Electronic address: yasmina.bendacha@ch-stdenis.fr.'}, {'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Portal', 'Affiliation': 'Clinical research unit, hôpital Fernand-Widal, AP-HP, 200, rue du Faubourg-Saint-Denis, 75475 Paris, France. Electronic address: jean-jacques.portal@aphp.fr.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Huten', 'Affiliation': 'Department of digestive surgery, CHU de Tours, 2, boulevard Tonnellé, 37000 Tours, France. Electronic address: huten@med.univ-tours.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chouillard', 'Affiliation': 'Department of digestive surgery, CHI de Poissy, 10, rue du Champ-Gaillard, 78303 Poissy, France. Electronic address: chouillard@yahoo.com.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': 'Department of digestive surgery, CHU de Nice, 151, route Saint-Antoine-de-Ginestière, 06202 Nice, France. Electronic address: gugenheim.j@chu-nice.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fourtanier', 'Affiliation': 'Department of digestive surgery, CHU de Toulouse, 1, avenue du Professeur-Jean-Poulhès, 31400 Toulouse, France. Electronic address: gilles@fourtanier.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Arapis', 'Affiliation': 'Department of digestive surgery, hôpital Bichat, AP-HP, 46, rue Henri-Huchard, 75877 Paris, France. Electronic address: konstantinos.arapis@bch.aphp.fr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of digestive surgery, hôpital Louis-Mourier, AP-HP, 178, rue des Renouillers, 92700 Colombes, France. Electronic address: simon.msika@aphp.fr.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Fabre', 'Affiliation': 'Department of digestive surgery, CHU de Montpellier, 80, avenue Augustin-Fiche, 34000 Montpellier, France. Electronic address: jm-fabre@chu-montpellier.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sodji', 'Affiliation': 'Department of digestive surgery, clinique des Émailleurs, 1, rue Victor-Schoelcher, 87000 Limoges, France. Electronic address: maximesodji87@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Clinical research unit, hôpital Fernand-Widal, AP-HP, 200, rue du Faubourg-Saint-Denis, 75475 Paris, France. Electronic address: eric.vicaut@aphp.fr.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dbouk', 'Affiliation': 'Department of digestive surgery, centre hospitalier de Saint-Denis, 2, rue du Docteur-Delafontaine, 93205 Saint-Denis, France. Electronic address: rami.dbouk@ch-stdenis.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Roussel', 'Affiliation': 'Department of digestive surgery, centre hospitalier de Saint-Denis, 2, rue du Docteur-Delafontaine, 93205 Saint-Denis, France. Electronic address: jyroussel@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of digestive surgery, centre hospitalier de Saint-Denis, 2, rue du Docteur-Delafontaine, 93205 Saint-Denis, France. Electronic address: regis.cohen@ch-stdenis.fr.'}]",Journal of visceral surgery,['10.1016/j.jviscsurg.2019.04.013'] 1112,31746546,Factors affecting the outcome of the suction blisters using two different harvesting techniques in vitiligo patients.,"BACKGROUND Suction blister grafting (SBG) technique has been used for long to treat various skin conditions. Different suction methods have been used such as syringes, Chinese cups, and suction device. There are some limitations of its use as time consumption, failure of induction or incomplete blister formation and pain. AIM The aim of this work was to evaluate the outcome of using two different suction techniques, namely the syringes and the Chinese cups in induction of suction blisters. The effect of the device diameter and preheating of the donor area on the suction blister induction time (SBIT) was studied. The effect of saline injection in the blister formation and its completion was also evaluated. METHODS The study was a left-right comparative study that included 50 patients with stable nonsegmental vitiligo. They were classified into four groups: Group 1 included 15 patients where different diameters of syringes (1.3, 1.7, and 2 cm) were compared against each other, group 2 included 15 patients where different diameters of cups (2, 3.5, and 5 cm) were compared against each other, group 3 included 20 patients subdivided into two groups; 10 patients each, where the effect of preheating the skin on blister induction was tested with use of cups (3a) and syringes (3b). Lastly, group 4 included randomly chosen 40 incomplete or multilocular blisters where the effect of saline injection on blister completion and coalescence of multilobulation was examined. SBIT was calculated in all patients. RESULTS The use of the small diameter syringes or cups gave shorter SBIT; however, the difference, which was significant between all sizes of cups, was significant between the 1.3- and 2-cm-diameter syringes only. Preheating of the donor area shorten SBIT significantly. No complications were reported at the donor site except for transient postinflammatory hyperpigmentation in all patients. CONCLUSION The small diameter syringes or cups and preheating of the donor area shorten the SBIT, while intra-blister saline injection increased the blister size and turns the multilocular blisters to unilocular ones.",2020,"No complications were reported at the donor site except for transient postinflammatory hyperpigmentation in all patients. ","['vitiligo patients', '50 patients with stable nonsegmental vitiligo']","['Suction blister grafting (SBG) technique', 'saline injection']","['SBIT', 'suction blister induction time (SBIT', 'transient postinflammatory hyperpigmentation']","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1319688', 'cui_str': 'Blister - unit of product usage'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1319688', 'cui_str': 'Blister - unit of product usage'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation (morphologic abnormality)'}]",40.0,0.0404801,"No complications were reported at the donor site except for transient postinflammatory hyperpigmentation in all patients. ","[{'ForeName': 'Tag S', 'Initials': 'TS', 'LastName': 'Anbar', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Hasan M', 'Initials': 'HM', 'LastName': 'El-Fakahany', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'El-Khayyat', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Amal T', 'Initials': 'AT', 'LastName': 'Abdel-Rahman', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Enas K', 'Initials': 'EK', 'LastName': 'Saad', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Matay Central Hospital, Minia, Egypt.""}]",Journal of cosmetic dermatology,['10.1111/jocd.13222'] 1113,31891449,Oral roxadustat three times weekly in ESA-naïve and ESA-converted patients with anemia of chronic kidney disease on hemodialysis: Results from two phase 3 studies.,"Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for anemia of dialysis-dependent chronic kidney disease (CKD). Japanese hemodialysis patients with anemia of CKD previously naïve to, or converted from, erythropoiesis-stimulating agents (ESAs) were enrolled in two open-label, noncomparative studies of titrated oral roxadustat administered three times weekly. ESA-naïve patients (n = 75) were randomized to roxadustat (initial dose, 50 or 70 mg) for 24 weeks; ESA-converted patients (n = 164) were assigned to roxadustat (initial dose, 70 or 100 mg based on prior ESA dose) for 52 weeks. Efficacy outcomes included average hemoglobin (Hb, weeks 18-24 or 46-52), change of Hb from baseline to weeks 18 to 24 (ΔHb 18-24 ) or weeks 46 to 52 (ΔHb 46-52 ), and maintenance rate (proportion of patients who achieved average Hb of 10.0-12.0 g/dL for weeks 18-24 or weeks 46-52). Treatment-emergent adverse events (TEAEs) were monitored. Mean (SD) Hb was 10.93 (0.79) g/dL (weeks 18-24) (ESA-Naïve Study), and 10.93 (0.69; weeks 18-24) g/dL and 11.11 (0.67; weeks 46-52) g/dL (ESA-Converted Study). Mean (SD) ΔHb 18-24 was 2.26 (1.02) g/dL (ESA-Naïve Study) and -0.03 (0.90) g/dL (ESA-Converted Study); mean (SD) ΔHb 46-52 was 0.12 (0.83) g/dL (ESA-Converted Study). The overall maintenance rate was 73.0% (54/74) (ESA-Naïve Study) (weeks 18-24), and 79.1% (129/163; weeks 18-24) and 71.2% (116/163; weeks 46-52) (ESA-Converted Study). Nasopharyngitis was the most common TEAE. Two deaths, considered unrelated to roxadustat, occurred in the ESA-Converted Study. Roxadustat effectively corrected and maintained Hb, regardless of previous ESA treatment, in Japanese anemic CKD patients on hemodialysis.",2019,"Roxadustat effectively corrected and maintained Hb, regardless of previous ESA treatment, in Japanese anemic CKD patients on hemodialysis.","['Japanese hemodialysis patients with anemia of CKD previously naïve to, or converted from, erythropoiesis-stimulating agents (ESAs', 'Patients With Anemia of Chronic Kidney Disease on Hemodialysis', 'ESA-naïve patients (n=75', 'Japanese anemic CKD patients on hemodialysis']","['dL', 'ESA-converted patients (n=164) were assigned to roxadustat']","['average hemoglobin', 'overall maintenance rate', 'Nasopharyngitis']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]","[{'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4310578'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",,0.022293,"Roxadustat effectively corrected and maintained Hb, regardless of previous ESA treatment, in Japanese anemic CKD patients on hemodialysis.","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Shiga', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Astellas Pharma Europe B.V., Leiden, The Netherlands.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13468'] 1114,31721407,Tubeless supra-costal percutaneous nephrolithotomy is associated with significantly less hydrothorax: a prospective randomized clinical study.,"OBJECTIVES To evaluate prospectively whether a tubeless (JJ stent-only) percutaneous nephrolithotomy (PCNL) might reduce the risk of hydrothorax, compared to an approach where a nephrostomy tube is left. MATERIALS AND METHODS We conducted a two-arm open-label prospective randomized study (NCT02036398) comparing tubeless supra-costal PCNL (with a JJ stent only) to standard PCNL (with nephrostomy tube and JJ stent) using intention-to-treat (ITT) and per-protocol (PP) analyses. All patients underwent a standard single-stage prone supra-costal procedure with single-tract access. Complication data were collected according to the Clavien-Dindo grading system. The primary endpoint was the rate of hydrothorax, and secondary endpoints included stone-free rate (SFR) and complication rate. Multivariable logistic regression analysis identified factors associated with hydrothorax formation. RESULTS Out of 101 patients approached, 75 were finally analysed. No differences were observed between the two arms with regard to baseline demographic and stone characteristics. The mean largest stone size ranged between 23 and 24.2 mm. No significant difference was seen in the mean operating time and length of hospital stay. The incidence of hydrothorax was significantly higher in the nephrostomy group in comparison to the tubeless group (37.8% vs 15.8%, P = 0.031, and 38.4% vs 13.8%, P = 0.016, in the ITT and PP analyses, respectively). The SFR and complication rate were similar in both groups using the ITT and PP analyses. Multivariable logistic regression analysis showed that nephrostomy tube placement was the only covariate associated in a statistically significant manner to hydrothorax (odds ratio 3.628, 95% confidence interval 1.073-12.265; P = 0.038). CONCLUSION The rate of hydrothorax in supra-costal PCNL is associated with the type of postoperative drainage left. When possible, a tubeless approach should be applied as it may confer a lower risk of hydrothorax.",2020,"The incidence of hydrothorax was significantly higher in the nephrostomy group in comparison to the tubeless group (37.8% vs. 15.8%, p=0.031, and 38.4% vs. 13.8%, p=0.016, in the ITT and PP analyses, respectively).","['101 patients approached, a total of 75 patients were finally analyzed']","['tubeless (double-J stent only) percutaneous nephrolithotomy (PN', 'tubeless supra-costal PN (with double-J stent only) to standard PN (with nephrostomy tube and double-J stent) using intention-to-treat (ITT) and per protocol (PP) analysis', 'Tubeless Supracostal Percutaneous Nephrolithotomy', 'standard single-stage prone supra-costal procedure with single tract access']","['incidence of hydrothorax', 'stone-free-rate and complication rate', 'mean largest stone size', 'rate of hydrothorax', 'mean operative time and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0441293', 'cui_str': 'JJ-stent (physical object)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184149', 'cui_str': 'Nephrostomy tube (physical object)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020312', 'cui_str': 'Hydrothorax'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",101.0,0.0896166,"The incidence of hydrothorax was significantly higher in the nephrostomy group in comparison to the tubeless group (37.8% vs. 15.8%, p=0.031, and 38.4% vs. 13.8%, p=0.016, in the ITT and PP analyses, respectively).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Goldberg', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Amihay', 'Initials': 'A', 'LastName': 'Nevo', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Yariv', 'Initials': 'Y', 'LastName': 'Shtabholtz', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lubin', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Ehrlich', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lifshitz', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}]",BJU international,['10.1111/bju.14950'] 1115,31732485,"Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial.","BACKGROUND New anti-tuberculosis regimens that are shorter, simpler, and less toxic than those that are currently available are needed as part of the global effort to address the tuberculosis epidemic. We aimed to investigate the bactericidal activity and safety profile of combinations of bedaquiline, pretomanid, moxifloxacin, and pyrazinamide in the first 8 weeks of treatment of pulmonary tuberculosis. METHODS In this multicentre, open-label, partially randomised, phase 2b trial, we prospectively recruited patients with drug-susceptible or rifampicin-resistant pulmonary tuberculosis from seven sites in South Africa, two in Tanzania, and one in Uganda. Patients aged 18 years or older with sputum smear grade 1+ or higher were eligible for enrolment, and a molecular assay (GeneXpert or MTBDRplus) was used to confirm the diagnosis of tuberculosis and to distinguish between drug-susceptible and rifampicin-resistant tuberculosis. Patients who were HIV positive with a baseline CD4 cell count of less than 100 cells per uL were excluded. Patients with drug-susceptible tuberculosis were randomly assigned (1:1:1) using numbered treatment packs with sequential allocation by the pharmacist to receive 56 days of treatment with standard tuberculosis therapy (oral isoniazid, rifampicin, pyrazinamide, and ethambutol; HRZE), or pretomanid (oral 200 mg daily) and pyrazinamide (oral 1500 mg daily) with either oral bedaquiline 400 mg daily on days 1-14 then 200 mg three times per week (B load PaZ) or oral bedaquiline 200 mg daily (B 200 PaZ). Patients with rifampicin-resistant tuberculosis received 56 days of the B 200 PaZ regimen plus moxifloxacin 400 mg daily (BPaMZ). All treatment groups were open label, and randomisation was not stratified. Patients, trial investigators and staff, pharmacists or dispensers, laboratory staff (with the exception of the mycobacteriology laboratory staff), sponsor staff, and applicable contract research organisations were not masked. The primary efficacy outcome was daily percentage change in time to sputum culture positivity (TTP) in liquid medium over days 0-56 in the drug-susceptible tuberculosis population, based on non-linear mixed-effects regression modelling of log 10 (TTP) over time. The efficacy analysis population contained patients who received at least one dose of medication and who had efficacy data available and had no major protocol violations. The safety population contained patients who received at least one dose of medication. This study is registered with ClinicalTrials.gov, NCT02193776, and all patients have completed follow-up. FINDINGS Between Oct 24, 2014, and Dec 15, 2015, we enrolled 180 patients with drug-susceptible tuberculosis (59 were randomly assigned to B load PaZ, 60 to B 200 PaZ, and 61 to HRZE) and 60 patients with rifampicin-resistant tuberculosis. 57 patients in the B load PaZ group, 56 in the B 200 PaZ group, and 59 in the HRZE group were included in the primary analysis. B 200 PaZ produced the highest daily percentage change in TTP (5·17% [95% Bayesian credibility interval 4·61-5·77]), followed by B load PaZ (4·87% [4·31-5·47]) and HRZE group (4·04% [3·67-4·42]). The bactericidal activity in B 200 PaZ and B load PaZ groups versus that in the HRZE group was significantly different. Higher proportions of patients in the B load PaZ (six [10%] of 59) and B 200 PaZ (five [8%] of 60) groups discontinued the study drug than in the HRZE group (two [3%] of 61) because of adverse events. Liver enzyme elevations were the most common grade 3 or 4 adverse events and resulted in the withdrawal of ten patients (five [8%] in the B load PaZ group, three [5%] in the B 200 PaZ group, and two [3%] in the HRZE group). Serious treatment-related adverse events affected two (3%) patients in the B load PaZ group and one (2%) patient in the HRZE group. Seven (4%) patients with drug-susceptible tuberculosis died and four (7%) patients with rifampicin-resistant tuberculosis died. None of the deaths were considered to be related to treatment. INTERPRETATION B 200 PaZ is a promising regimen to treat patients with drug-susceptible tuberculosis. The bactericidal activity of both these regimens suggests that they have the potential to shorten treatment, and the simplified dosing schedule of B 200 PaZ could improve treatment adherence in the field. However, these findings must be investigated further in a phase 3 trial assessing treatment outcomes. FUNDING TB Alliance, UK Department for International Development, Bill & Melinda Gates Foundation, US Agency for International Development, Directorate General for International Cooperation of the Netherlands, Irish Aid, Australia Department of Foreign Affairs and Trade, and the Federal Ministry for Education and Research of Germany.",2019,"B 200 PaZ produced the highest daily percentage change in TTP (5·17% [95% Bayesian credibility interval 4·61-5·77]), followed by B load PaZ (4·87% [4·31-5·47]) and HRZE group (4·04% [3·67-4·42]).","['57 patients in the B load PaZ group, 56 in the B 200 PaZ group, and 59 in the HRZE group were included in the primary analysis', 'Patients, trial investigators and staff, pharmacists or dispensers, laboratory staff (with the exception of the mycobacteriology laboratory staff), sponsor staff, and applicable contract research organisations were not masked', 'Patients with rifampicin-resistant tuberculosis', 'pulmonary tuberculosis', 'Patients aged 18 years or older with sputum smear grade 1+ or higher were eligible for enrolment, and a molecular assay (GeneXpert or MTBDRplus) was used to confirm the diagnosis of tuberculosis and to distinguish between drug-susceptible and rifampicin-resistant tuberculosis', 'Patients who were HIV positive with a baseline CD4 cell count of less than 100 cells per uL were excluded', 'Patients with drug-susceptible tuberculosis', 'Between Oct 24, 2014, and Dec 15, 2015, we enrolled 180 patients with drug-susceptible tuberculosis (59', 'patients with drug-susceptible or drug-resistant pulmonary tuberculosis', 'patients with drug-susceptible or rifampicin-resistant pulmonary tuberculosis from seven sites in South Africa, two in Tanzania, and one in Uganda', 'patients with drug-susceptible tuberculosis']","['oral bedaquiline', 'standard tuberculosis therapy (oral isoniazid, rifampicin, pyrazinamide, and ethambutol; HRZE), or pretomanid (oral 200 mg daily) and pyrazinamide (oral 1500 mg daily) with either oral bedaquiline', 'Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide', 'bedaquiline, pretomanid, moxifloxacin, and pyrazinamide', 'HRZE', 'rifampicin-resistant tuberculosis', 'moxifloxacin 400 mg daily (BPaMZ']","['Liver enzyme elevations', 'adverse events', 'daily percentage change in time to sputum culture positivity (TTP', 'bactericidal activity', 'TTP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0035168'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1664205', 'cui_str': 'bedaquiline'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C4310440'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}]","[{'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity (observable entity)'}]",180.0,0.193834,"B 200 PaZ produced the highest daily percentage change in TTP (5·17% [95% Bayesian credibility interval 4·61-5·77]), followed by B load PaZ (4·87% [4·31-5·47]) and HRZE group (4·04% [3·67-4·42]).","[{'ForeName': 'Conor D', 'Initials': 'CD', 'LastName': 'Tweed', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK. Electronic address: c.tweed@ucl.ac.uk.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'University of Cape Town Lung Institute, Cape Town, South Africa; Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Divan A', 'Initials': 'DA', 'LastName': 'Burger', 'Affiliation': 'Department of Statistics, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Almari', 'Initials': 'A', 'LastName': 'Conradie', 'Affiliation': 'TB Alliance, Pretoria, South Africa.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Mendel', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Conradie', 'Affiliation': 'Clinical HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'TASK Applied Science, Bellville, South Africa; Division of Physiology, Department of Medical Biochemistry, Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Nyanda E', 'Initials': 'NE', 'LastName': 'Ntinginya', 'Affiliation': 'NIMR-Mbeya Medical Research Centre, Mbeya, Tanzania.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Everitt', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Haraka', 'Affiliation': 'Ifakara Health Institute Bagamoyo Research and Training Center, Bagamoyo, Tanzania.'}, {'ForeName': 'Mengchun', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'Christo H', 'Initials': 'CH', 'LastName': 'van Niekerk', 'Affiliation': 'TB Alliance, Pretoria, South Africa.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Okwera', 'Affiliation': 'Uganda Case Western Reserve University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mohammed S', 'Initials': 'MS', 'LastName': 'Rassool', 'Affiliation': 'Clinical HIV Research Unit, Helen Joseph Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Reither', 'Affiliation': 'Ifakara Health Institute Bagamoyo Research and Training Center, Bagamoyo, Tanzania; Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Modulakgotla A', 'Initials': 'MA', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Tembisa Hospital, Tembisa, South Africa.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Staples', 'Affiliation': 'THINK, Durban, South Africa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'MDR Unit, Klerksdorp Tshepong Hospital, Klerksdorp, South Africa.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Spigelman', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30366-2'] 1116,31553661,"Adjuvant Whole-Brain Radiation Therapy Compared With Observation After Local Treatment of Melanoma Brain Metastases: A Multicenter, Randomized Phase III Trial.","PURPOSE The brain is a common site of metastasis for patients with high-risk melanoma. Although surgery or stereotactic radiosurgery are highly effective local treatments for a small number of metastases, there is a high risk of developing additional brain metastases. The role of adjuvant whole-brain radiotherapy (WBRT) in reducing new metastases is controversial, with a lack of high-level evidence specifically for melanoma. METHODS In this randomized phase III trial, patients who had local treatment of one to three melanoma brain metastases were randomly assigned to WBRT or observation. The primary end point was distant intracranial failure within 12 months, and secondary end points included time to intracranial failure, survival, and time to deterioration in performance status. RESULTS Between April 2009 and September 2017, 215 patients were randomly assigned from 24 centers. Median follow-up was 48.1 months (range, 39.6 to 68 months). Forty-two percent of patients in the WBRT group and 50.5% of those in the observation developed distant intracranial failure within 12 months (odds ratio, 0.71; 95% CI, 0.41 to 1.23; P = .22) and the rates over the entire follow-up period were 52.0% and 57.9%, respectively (odds ratio, 0.79; 95% CI, 0.45 to 1.36; P = .39). Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03). At 12 months, 41.5% of patients in the WBRT group and 51.4% of patients in the observation group had died ( P = .28), with no difference in the rate of neurologic death. Median time to deterioration in performance status was 3.8 months after WBRT and 4.4 months with observation ( P = .32). WBRT was associated with more grade 1 to 2 acute toxicity. CONCLUSION After local treatment of one to three melanoma brain metastases, adjuvant WBRT does not provide clinical benefit in terms of distant intracranial control, survival, or preservation of performance status.",2019,Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03).,"['patients who had local treatment of one to three melanoma brain metastases', 'patients with high-risk melanoma', 'Melanoma Brain Metastases', 'Between April 2009 and September 2017, 215 patients were randomly assigned from 24 centers']","['Observation', 'Adjuvant Whole-Brain Radiation Therapy', 'WBRT', 'WBRT or observation', 'adjuvant whole-brain radiotherapy (WBRT', 'stereotactic radiosurgery']","['Local failure rate', 'died', 'time to intracranial failure, survival, and time to deterioration in performance status', 'Median time to deterioration in performance status', 'distant intracranial failure', 'rate of neurologic death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",215.0,0.297748,Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03).,"[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Hong', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gerald B', 'Initials': 'GB', 'LastName': 'Fogarty', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Dolven-Jacobsen', 'Affiliation': 'Oslo University Hospital, The Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'Burmeister', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Serigne N', 'Initials': 'SN', 'LastName': 'Lo', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Haydu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Janette L', 'Initials': 'JL', 'LastName': 'Vardy', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'University of Western Australia, WA, Australia.'}, {'ForeName': 'Haryana M', 'Initials': 'HM', 'LastName': 'Dhillon', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tasnia', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brindha', 'Initials': 'B', 'LastName': 'Shivalingam', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Menzies', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hruby', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Katharine J', 'Initials': 'KJ', 'LastName': 'Drummond', 'Affiliation': 'Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mandel', 'Affiliation': 'Swinburne University of Technology, Hawthorn, VIC, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'National Institute for Health Research Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Claudius H', 'Initials': 'CH', 'LastName': 'Reisse', 'Affiliation': 'Oslo University Hospital, The Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Paton', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Steel', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Narelle C', 'Initials': 'NC', 'LastName': 'Williams', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Scolyer', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Morton', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Thompson', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01414'] 1117,31106351,Physiotherapeutic intervention to promote self-care: exploratory study on Spanish caregivers of patients with dementia.,"The caregivers of dependent persons should benefit from social-health interventions that empower them. Physiotherapists can play an important role as facilitators of self-care learning by boosting the mind-body interaction. The aim of this study was to analyse the efficacy of a physiotherapeutic intervention centered on the promotion of self-care within a sample of caregivers, members of four Spanish Associations of Relative of Alzheimer's and other dementias. To fulfill the study goal, a pre-experimental study was developed with two different groups. Group 1 participated in four training sessions based exclusively on the communication of information and which addressed, among other aspects, the most frequent health problems in caregivers and the powerful role of self-care to face such problems. Group 2 received the same theoretical information as group 1, followed by 10 sessions of practical training in several concrete strategies of body-mind self-care. The results obtained support the usefulness of combining theoretical and practical training in mind-body strategies (relaxation, self-massage and stretching), as such combination managed to favor their implication to self-care and certain dimensions of psychological well-being, while attenuating the burden. Conversely, training based solely on theoretical approaches was not beneficial. Besides evidencing the usefulness of combining passive and active methodologies to favor self-care, the data provided calls for greater consideration of aspects close to philosophical perspectives like personal growth.",2020,Physiotherapists can play an important role as facilitators of self-care learning by boosting the mind-body interaction.,"['Spanish caregivers of patients with dementia', ""sample of caregivers, members of four Spanish Associations of Relative of Alzheimer's and other dementias""]","['practical training in several concrete strategies of body-mind self-care', 'physiotherapeutic intervention', 'Physiotherapeutic intervention']",[],"[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0557857', 'cui_str': 'Concrete (substance)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]",[],,0.0147349,Physiotherapists can play an important role as facilitators of self-care learning by boosting the mind-body interaction.,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Alonso-Cortés', 'Affiliation': 'SALBIS Research Group, Department of Nursing and Physiotherapy, School of Health Sciences, University of León, Avenida Astorga s/n, Ponferrada 24401, León, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Seco-Calvo', 'Affiliation': 'Department of Nursing and Physiotherapy, School of Health Sciences, University of León, Avenida Astorga s/n, Ponferrada 24401, León, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'González-Cabanach', 'Affiliation': 'Department of Evolutionary Psychology and Education, University of A Coruña, Campus de Elviña, 15071 A Coruña, Spain.'}]",Health promotion international,['10.1093/heapro/daz045'] 1118,31624988,Visual acuity and defocus curves with six multifocal intraocular lenses.,"PURPOSE The purpose of this prospective, randomized, double-masked, study was to compare the visual performance of patients after bilateral implantation of six different IOLs. METHODS The following IOLs were used in the study: SV25T0 (n = 19), ATLISA 809M (n = 18), ATLISA Tri 839MP (n = 19), ZKB00 (n = 20), ZLB00 (n = 20) and Symfony ZXR00 (n = 20). Visual performance was assessed by the monocular distance-corrected visual acuity at 4 m (CDVA), distance-corrected intermediate visual acuity (DCIVA) at 60 cm and distance-corrected near visual acuity (DCNVA) at 40 cm. Binocular defocus curves were obtained for a range of defocus from + 1.50 D to - 4.50 D, in 0.50 D steps. Quality of life was assessed with the VF-14 questionnaire. RESULTS CDVA was better with the Symfony ZXR00 than with the SV25T0 (p = 0.032), ATLISA Tri 839MP (p = 0.032) and ATLISA 809M (p = 0.018). The Symfony ZXR00 offered the best DCIVA, followed by the ZKB00. The best and worst DCNVA results corresponded to the ZLB00, and the SV25T0 and Symfony ZXR00, respectively. Defocus curves at distance were good in all groups, although the Symfony had a wider range of clear vision (- 1.50 D to + 0.50 D), with no decay. For intermediate vision, only the Symfony obtained sharp visual acuity. The ATLISA 809M, ATLISA Tri 839MP and ZLB00 were superior at near distance. CONCLUSIONS The extended depth of focus of the Symfony ZXR00 offers a superior range of clear vision at far and intermediate distances than other multifocal designs, with worse results at near distance. Visual outcomes reflect the particular optical, geometrical and power distribution characteristics of each IOL.",2020,"Defocus curves at distance were good in all groups, although the Symfony had a wider range of clear vision (- 1.50 D to + 0.50 D), with no decay.",['patients after bilateral implantation of six different IOLs'],"['ZLB00 (n\u2009=\u200920) and Symfony ZXR00', 'ZKB00', 'ATLISA']","['visual performance', 'Visual performance', 'Quality of life', 'monocular distance-corrected visual acuity at 4\xa0m (CDVA), distance-corrected intermediate visual acuity (DCIVA) at 60\xa0cm and distance-corrected near visual acuity (DCNVA', 'wider range of clear vision', 'Visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",[],"[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",,0.128996,"Defocus curves at distance were good in all groups, although the Symfony had a wider range of clear vision (- 1.50 D to + 0.50 D), with no decay.","[{'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Gil', 'Affiliation': 'Ophthalmology Department, Santa Creu and Sant Pau Hospital, carrer de Sant Quintí, 89, 08041, Barcelona, Spain.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Varón', 'Affiliation': 'Department of Optics and Optometry, Terrassa School of Optics and Optometry, Universitat Politècnica de Catalunya, carrer Violinista Vellsolà, 37, 08222, Terrassa, Catalonia, Spain.'}, {'ForeName': 'Genis', 'Initials': 'G', 'LastName': 'Cardona', 'Affiliation': 'Department of Optics and Optometry, Terrassa School of Optics and Optometry, Universitat Politècnica de Catalunya, carrer Violinista Vellsolà, 37, 08222, Terrassa, Catalonia, Spain. genis.cardona@upc.edu.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Buil', 'Affiliation': 'Ophthalmology Department, Santa Creu and Sant Pau Hospital, carrer de Sant Quintí, 89, 08041, Barcelona, Spain.'}]",International ophthalmology,['10.1007/s10792-019-01196-4'] 1119,31083052,Moderators of Response to Cognitive Behavior Therapy for Major Depression in Patients With Heart Failure.,"OBJECTIVE Although cognitive behavior therapy (CBT) is efficacious for major depression in patients with heart failure (HF), approximately half of patients do not remit after CBT. To identify treatment moderators that may help guide treatment allocation strategies and serve as new treatment targets, we performed a secondary analysis of a randomized clinical trial. Based on evidence of their prognostic relevance, we evaluated whether clinical and activity characteristics moderate the effects of CBT. METHODS Participants were randomized to enhanced usual care (UC) alone or CBT plus enhanced UC. The single-blinded outcomes were 6-month changes in Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9). Actigraphy was used to assess daily physical activity patterns. We performed analyses to identify the specific activity and clinical moderators of the effects of CBT in 94 adults (mean age = 58, 49% female) with HF and major depressive disorder. RESULTS Patients benefited more from CBT (versus UC) if they had the following: more medically severe HF (i.e., a higher New York Heart Association class or a lower left ventricular ejection fraction), more stable activity patterns, wider active periods, and later evening settling times. These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). CONCLUSIONS These findings suggest that increasing the cross-daily stability of activity patterns, and prolonging the daily active period, might help increase the efficacy of CBT. Given moderating effects of HF severity measures, research is also needed to clarify and address factors in patients with less severe HF that diminish the efficacy of CBT. CLINICAL TRIAL REGISTRATION clinicaltrials.gov identifier: NCT01028625.",2019,"These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). ","['patients with heart failure (HF', 'patients with less severe HF', 'Patients With Heart Failure', '94 adults (mean age = 58, 49% female) with HF and major depressive disorder', 'Participants']","['cognitive behavior therapy (CBT', 'Cognitive Behavior Therapy', 'enhanced usual care (UC) alone or CBT plus enhanced UC', 'CBT']","['daily physical activity patterns', 'Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",,0.103956,"These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). ","[{'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Smagula', 'Affiliation': 'From the Department of Psychiatry (Smagula, Wallace), School of Medicine, University of Pittsburgh; Department of Epidemiology (Smagula), Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA; Department of Psychiatry (Freedland, Steinmeyer, R.M. Carney), Washington University School of Medicine; and Division of Cardiology (M.W. Carney), Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Freedland', 'Affiliation': ''}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Steinmeyer', 'Affiliation': ''}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000712'] 1120,31732742,Effect of alirocumab on cardiovascular outcomes after acute coronary syndromes according to age: an ODYSSEY OUTCOMES trial analysis.,"AIMS Lowering low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular risk irrespective of age, but the evidence is less strong for older patients. METHODS AND RESULTS This prespecified analysis from ODYSSEY OUTCOMES compared the effect of alirocumab vs. placebo in 18 924 patients with recent acute coronary syndrome (ACS) according to age. We examined the effect of assigned treatment on occurrence of the primary study outcome, a composite of coronary heart disease death, myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization [major adverse cardiovascular event (MACE)] and all-cause death. Relative risk reductions were consistent for patients ≥65 vs. <65 years for MACE [hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.68-0.91 vs. 0.89, 0.80-1.00; Pinteraction = 0.19] and all-cause death [HR 0.77, 0.62-0.95 vs. 0.94, 0.77-1.15; Pinteraction = 0.46], and consistent for MACE when dichotomizing at age 75 years (HR 0.85, 0.64-1.13 in ≥75 vs. 0.85, 0.78-0.93 in <75, Pinteraction = 0.19). When considering age as a continuous variable in regression models, advancing age increased risk of MACE, as well as the absolute reduction in MACE with alirocumab, with numbers-needed-to-treat for MACE at 3 years of 43 (25-186) at age 45 years, 26 (15-97) at age 75 years, and 12 (6-81) for those at age 85 years. Although adverse events were more frequent in older patients, there were no differences between alirocumab and placebo. CONCLUSION In patients with recent ACS, alirocumab improves outcomes irrespective of age. Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.",2020,Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.,"['acute coronary syndromes according to age', 'older patients after ACS', '18\xa0924 patients with recent acute coronary syndrome (ACS) according to age', 'older patients']","['alirocumab vs. placebo', 'alirocumab', 'AIMS\n\n\nLowering low-density lipoprotein cholesterol (LDL-C']","['composite of coronary heart disease death, myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization [major adverse cardiovascular event (MACE', 'cardiovascular outcomes', 'adverse events', 'Relative risk reductions']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.153476,Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.,"[{'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Box B130, Aurora, CO 80045, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University Medical Center, 200 Morris Street, Durham, NC 27701, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'Department of Cardiology, Amphia Ziekenhuis Molengracht, 4818 CK Breda, Netherlands.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Shih-Pai Road, 11217 Taipei, Taiwan.'}, {'ForeName': 'Roger M', 'Initials': 'RM', 'LastName': 'Correa Flores', 'Affiliation': 'Department of Internal Medicine, Cardiology, Alberto Sabogal Sologuren, ESSALUD, Jirón Colina 1081, Bellavista - Callao, Lima CA01, Peru.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Cardiology Department, Instituto Cardiovascular de Rosario, Paraguay 160, Santa Fe, Rosario 2000, Argentina.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dorobantu', 'Affiliation': 'Cardiology Department, Emergency Clinical Hospital of Bucharest, 8 Calea Floreasca, ET 6 014461 Bucharest, Romania.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, 87 Ave NW, Edmonton, Alberta T6G 2E1, Canada.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, Netherlands.'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'R&D Clinical Development, Sanofi, 1 avenue Pierre Brossolette, 91380 Chilly-Mazarin, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Clinical Sciences - Cardiovascular & Metabolism Therapeutics, Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Rd, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University Medical Center, 200 Morris Street, Durham, NC 27701, USA.'}, {'ForeName': 'Rody G', 'Initials': 'RG', 'LastName': 'Sy', 'Affiliation': 'Cardiovascular Institute, Cardinal Santos Medical Center, Wilson Street, San Juan, 1502 Metro Manila, Philippines.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Downstate School of Public Health, State University of New York, 450 Clarkson Avenue, MS 43, Brooklyn, NY 11203 USA.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland 20 City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hopital Bichat, Universiteé de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Assistance Publique-Hopitaux de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz809'] 1121,31058771,A Randomized Trial of Maternal Docosahexaenoic Acid Supplementation to Reduce Inflammation in Extremely Preterm Infants.,"Maternal supplementation with 1000 mg/day docosahexaenoic acid (DHA) provides third trimester DHA accretion levels in breast milk for the preterm infant. We hypothesized that DHA supplementation to mothers providing breastmilk for extremely preterm infants would result in decreased inflammatory markers, in the infant. Mother/infant dyads (n = 27) were enrolled at birth and mothers were assigned to receive 200 or 1000 mg/day of DHA. Milk and plasma samples were analyzed for fatty acids and inflammatory markers. Decreases in inflammation were observed in both maternal and infant plasma and correlated with red blood cell (RBC) DHA levels. The fact that maternal DHA supplementation decreases infant markers of inflammation implies that DHA, delivered through breastmilk, has the potential to decrease inflammation in the infant.",2019,"We hypothesized that DHA supplementation to mothers providing breastmilk for extremely preterm infants would decrease inflammatory markers, in the infant.","['Extremely Preterm Infants', 'Mother/infant dyads (n\u200a=\u200a27) were enrolled at birth and mothers']","['DHA supplementation', 'Maternal Docosahexaenoic Acid Supplementation', 'Maternal supplementation with 1000\u200amg/day docosahexaenoic acid (DHA']","['red blood cell (RBC) DHA levels', 'inflammation']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.273033,"We hypothesized that DHA supplementation to mothers providing breastmilk for extremely preterm infants would decrease inflammatory markers, in the infant.","[{'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Valentine', 'Affiliation': 'The University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Dingess', 'Affiliation': 'Biomolecular Mass Spectrometry and Proteomics, Bijvoet Center for Biomolecular Research and Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, The Netherlands.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Kleiman', 'Affiliation': ""Cincinnati Children's Hospital, Center for Infectious Diseases, Cincinnati.""}, {'ForeName': 'Ardythe L', 'Initials': 'AL', 'LastName': 'Morrow', 'Affiliation': 'The University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Lynette K', 'Initials': 'LK', 'LastName': 'Rogers', 'Affiliation': ""The Research Institute at Nationwide Children's Hospital, Columbus, OH.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002375'] 1122,31741252,Vibrator-Assisted Start-Stop Exercises Improve Premature Ejaculation Symptoms: A Randomized Controlled Trial.,"Premature ejaculation (PE) is associated with decreased quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties. Here we investigated the effectiveness of vibrator-assisted start-stop exercises for treatment of PE, and whether the treatment effect could be enhanced by an additional psychobehavioral intervention. Fifty participants with a mean age of 41.7 years were included and randomized into two treatment groups and a waiting list control group. Participants were instructed to perform start-stop exercises while stimulating the penis with a purpose-made vibrator, 3 times a week for 6 weeks. Additionally, participants in one of the treatment groups received additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week. Data were gathered through online questionnaires before and after treatment, as well as 3 and 6 months after treatment. The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group). The additional psychobehavioral intervention did not further reduce PE symptoms, but did decrease PE-associated negative symptoms such as levels of sexual distress, anxiety, and depression. No side effects were reported. Vibrator-assisted start-stop exercises can be offered as an adequate treatment option for PE.",2020,"The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group).",['Fifty participants with a mean age of 41.7\xa0years'],"['Vibrator-Assisted Start-Stop Exercises', 'waiting list control group', 'additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week', 'vibrator-assisted start-stop exercises', 'Vibrator-assisted start-stop exercises']","['Premature Ejaculation Symptoms', 'Premature ejaculation (PE', 'sexual distress, anxiety, and depression', 'PE symptoms', 'quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184304', 'cui_str': 'Vibrator, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441633'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",50.0,0.0493297,"The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ventus', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Fabriksgatan 2, 20500, Turku, Finland. dventus@abo.fi.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Gunst', 'Affiliation': 'Department of Psychology, University of Turku, Turku, Finland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Katarina G', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Zamore-Söderström', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Kärnä', 'Affiliation': ', Turku, Finland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jern', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Fabriksgatan 2, 20500, Turku, Finland.'}]",Archives of sexual behavior,['10.1007/s10508-019-01520-0'] 1123,31015099,Treatment of anxiety and mood comorbidities in cognitive-behavioral and psychodynamic therapies for panic disorder.,"BACKGROUND It is not known whether common anxiety/mood comorbidities of panic disorder (PD) improve with panic-focused psychological treatment, nor whether there is differential efficacy between therapies in treating comorbidities. METHODS In a randomized controlled trial for PD with and without agoraphobia comparing Cognitive-Behavioral Therapy (CBT) and Panic-Focused Psychodynamic Psychotherapy (PFPP), symptomatic comorbidities of agoraphobia, MDD, GAD, and social anxiety disorder (SAD) were assessed pre-to-post treatment with the Anxiety Disorders Interview Schedule (ADIS). Comparative efficacy of CBT versus PFPP for treating comorbid disorders was tested at termination and 1 year's follow-up. Covariance between panic and comorbidity improvements was also analyzed. RESULTS Most treatment completers (n = 120) evidenced diagnostic remission of their comorbidity (range = 54-69%), which typically reflected a subclinical score on the ADIS (mean range = 1.3 to 1.8). These improvements were generally retained at follow-up. However, patients with MDD dropped out significantly more often (HR = 2.79). No significant symptom change or remission differences emerged between CBT and PFPP for any comorbidity at termination or at follow-up. Panic change was strongly related to improvements in agoraphobia (r = 0.70) and MDD (r = 0.53), moderately related for GAD (r = 0.31), and not significantly related for SAD (r = 0.20). DISCUSSION Patients completing panic-focused psychotherapies often experience meaningful remission for diagnoses of agoraphobia, MDD, GAD, and SAD, with no detectable differences between treatments, although sample sizes for the MDD and SAD comparisons were small. In addition, additional efforts may be needed to keep MDD-comorbid patients in treatment.",2019,No significant symptom change or remission differences emerged between CBT and PFPP for any comorbidity at termination or at follow-up.,['panic disorder'],"['CBT versus PFPP', 'PD with and without agoraphobia comparing Cognitive-Behavioral Therapy (CBT) and Panic-Focused Psychodynamic Psychotherapy (PFPP', 'cognitive-behavioral and psychodynamic therapies']","['agoraphobia', 'agoraphobia, MDD, GAD, and social anxiety disorder (SAD', 'MDD', 'Panic change', 'diagnostic remission of their comorbidity']","[{'cui': 'C0030319', 'cui_str': 'Panic Disorder'}]","[{'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",120.0,0.0231392,No significant symptom change or remission differences emerged between CBT and PFPP for any comorbidity at termination or at follow-up.,"[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Keefe', 'Affiliation': 'University of Pennsylvania, Department of Psychology, 425 S. University Avenue, Levin Building, 4th Floor, Philadelphia, PA, 19104, USA; Weill Cornell Medical College, Department of Psychiatry, New York, NY, USA. Electronic address: jack.keefe@gmail.com.'}, {'ForeName': 'Dianne L', 'Initials': 'DL', 'LastName': 'Chambless', 'Affiliation': 'University of Pennsylvania, Department of Psychology, 425 S. University Avenue, Levin Building, 4th Floor, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Adelphi University, Gordon F. Derner School of Psychology, Garden City, NY, USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Milrod', 'Affiliation': 'Weill Cornell Medical College, Department of Psychiatry, New York, NY, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.009'] 1124,31727347,Effects of Chinese square dancing on older adults with mild cognitive impairment.,"The present study aimed to explore the effects of square dancing on global cognition, depressive symptoms, balance, and quality of life of older adults with mild cognitive impairment. We studied 66 older adults with mild cognitive impairment in a large nursing home. Participants were assigned to the intervention group (n = 33) or the control group (n = 33), according to their residential floor, which was determined by coin tossing. The intervention group underwent a 12-week Chinese square dancing routine, while the control group maintained usual lifestyle (without square dancing). Outcomes were assessed at baseline and at weeks 6 and 12. The results showed positive effects of square dancing on all outcomes assessed, especially on depressive symptoms and quality of life-related mental well-being of the participants. This study showed that square dancing is a promising strategy for older adults with mild cognitive impairment and that long-term adherence can be beneficial.",2020,"The results showed positive effects of square dancing on all outcomes assessed, especially on depressive symptoms and quality of life-related mental well-being of the participants.","['66 older adults with mild cognitive impairment in a large nursing home', 'older adults with mild cognitive impairment']","['12-week Chinese square dancing routine, while the control group maintained usual lifestyle', 'Chinese square dancing', 'square dancing']","['global cognition, depressive symptoms, balance, and quality of life', 'depressive symptoms and quality of life-related mental']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",66.0,0.0510252,"The results showed positive effects of square dancing on all outcomes assessed, especially on depressive symptoms and quality of life-related mental well-being of the participants.","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Xiangfei', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Binghan', 'Initials': 'B', 'LastName': 'Shang', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Qiuyan', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Lufang', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China. Electronic address: lishengwang@ymail.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China. Electronic address: chen_care@126.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.10.009'] 1125,31728731,Efficiency of desensitizing materials in xerostomic patients with head and neck cancer: a comparative clinical study.,"OBJECTIVES To assess the clinical effectiveness of four desensitizing materials in patients who are xerostomic due to radiotherapy for head and neck cancer (HNC) in comparison to a healthy group with normal salivation. METHODS AND MATERIALS The study was conducted as a split-mouth randomized clinical trial. Forty HNC patients (group A) and 46 healthy patients (group B) suffering from dentin hypersensitivity (DH) were included. Salivary flow was determined through a scialometric test. Hypersensitivity was assessed with air stimulus and tactile stimulus. The materials used as desensitizing agents were Vertise Flow, Universal Dentin Sealant, Clearfil Protect Bond, and Flor-Opal Varnish. The response was recorded before application of the materials, immediately after, and at 1 week, 4 weeks, and 12 weeks. RESULTS Salivary flow rates in groups A/B were 0.15/0.53 mL/min (unstimulated) and 0.54/1.27 mL/min (stimulated), respectively. In group A, 100 hypersensitive teeth were included. Application of the desensitizing agents significantly decreased the hypersensitivity immediately and throughout the 4-week follow-up (p < 0.001). However, after the 12-week timepoint, a loss of efficacy was detected in all agents (p = 0.131). In group B, 116 hypersensitive teeth were included. The materials performed a more stable action, although a loss of effectiveness was detected at 12-week control (p = 0.297). CONCLUSION The efficiency of the desensitizing agents after the first application was similar in both groups. In the radiated group, this effect lasted for shorter periods than in healthy controls. CLINICAL RELEVANCE HNC patients with hyposalivation may be a new risk group for DH.",2020,Application of the desensitizing agents significantly decreased the hypersensitivity immediately and throughout the 4-week follow-up (p < 0.001).,"['100 hypersensitive teeth were included', 'patients who are xerostomic due to radiotherapy for head and neck cancer (HNC) in comparison to a healthy group with normal salivation', 'Forty HNC patients (group A) and 46 healthy patients (group B) suffering from dentin hypersensitivity (DH) were included', 'xerostomic patients with head and neck cancer', '116 hypersensitive teeth were included', 'HNC patients with hyposalivation may be a new risk group for DH']",['desensitizing materials'],"['hypersensitivity', 'Hypersensitivity', 'loss of efficacy', 'Salivary flow']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0576991', 'cui_str': 'Normal salivation (finding)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C1278418', 'cui_str': 'MAY BE A'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",,0.01637,Application of the desensitizing agents significantly decreased the hypersensitivity immediately and throughout the 4-week follow-up (p < 0.001).,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pinna', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy. rpinna@uniss.it.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Milia', 'Affiliation': 'Department of Medicine, Surgery and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Usai', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Crivelli', 'Affiliation': 'Department of Medicine, Surgery and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pagano', 'Affiliation': 'Department of Surgical and Biomedical Sciences, University of Perugia, Perugia, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Department of Medicine, Surgery and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schmalz', 'Affiliation': 'Department of Conservative and Operative Dentistry, University Hospital Regensburg, Regensburg, Germany.'}]",Clinical oral investigations,['10.1007/s00784-019-03081-x'] 1126,31044556,Ultralow dose computed tomography protocol for hook-wire localization of solitary pulmonary nodules prior to video-assisted thoracoscopic surgery.,"BACKGROUND This study prospectively investigated the efficacy and radiation dose of ultralow dose computed tomography (CT)-guided hook-wire localization (HWL) at 100 kV with tin filtration (100Sn kV) for small solitary pulmonary nodules. METHODS All HWL procedures were performed on a third generation dual-source CT system. Eighty-eight consecutive patients undergoing CT-guided HWL were randomly assigned to standard dose CT (Group A: n = 44; reference 110 kV and 50 mA) or ultralow dose CT (Group B: n =44; 100 Sn kV and 96 mA) protocols. The technical success rate, complications, subjective image quality, and radiation dose were compared between the groups. RESULTS The mean volume CT dose index and total dose-length product were significantly lower in Group B compared to Group A (0.32 mGy vs. 3.2 ± 1.1 mGy and 12.1 ± 0.97 mGy-cm vs. 120 ± 40.6 mGy-cm; P < 0.001). The effective dose in Group B was significantly lower than in Group A (0.17 ± 0.01 mSv vs. 1.68 ± 0.57 mSv, -89.8%; P < 0.001). The technical success rates were 100% for both groups. There were no significant differences in complication rates between the protocols (P > 0.05). The image quality of ultralow dose CT met the requirements for HWL procedure. CONCLUSION Ultralow dose CT-guided HWL of solitary pulmonary nodules performed at 100 Sn kVp spectral shaping significantly reduced the radiation dose compared to standard dose CT, with high technical success and acceptable patient safety.",2019,"Sn kVp spectral shaping significantly reduced the radiation dose compared to standard dose CT, with high technical success and acceptable patient safety.","['small solitary pulmonary nodules', 'Eighty-eight consecutive patients undergoing CT-guided HWL']","['ultralow dose CT', 'Ultralow dose computed tomography protocol', 'video-assisted thoracoscopic surgery', 'ultralow dose computed tomography (CT)-guided hook-wire localization (HWL) at 100 kV with tin filtration (100Sn kV', 'standard dose CT']","['mean volume CT dose index and total dose-length product', 'technical success rates', 'complication rates', 'technical success rate, complications, subjective image quality, and radiation dose']","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C2350019', 'cui_str': 'Solitary Pulmonary Nodule'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0181209', 'cui_str': 'Hook (attribute)'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]",88.0,0.0268142,"Sn kVp spectral shaping significantly reduced the radiation dose compared to standard dose CT, with high technical success and acceptable patient safety.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""Department of Respiratory Medicine, Dezhou People's Hospital, Dezhou, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, Jinan Central Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Radiology, Xiamen Hospital of Traditional Chinese Medicine, Xiamen, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Chunhai', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}]",Thoracic cancer,['10.1111/1759-7714.13075'] 1127,32078609,Racial Differences in Pain Management for Patients Receiving Hospice Care.,"OBJECTIVES To investigate racial differences in implementation of 11 evidence-based cancer pain management strategies in a matched sample of patients in hospice. SAMPLE & SETTING 32 African American and 32 Caucasian American older adults (aged 65 years or older) with cancer pain receiving hospice care in the midwestern United States. METHODS & VARIABLES Matched cohort secondary data analysis of postintervention data in a cluster randomized controlled trial was used. Main outcomes are the summative and individual Cancer Pain Practice Index scores. RESULTS There were few statistically significant or clinically meaningful differences in implementation of individual best practices for pain management by race. Assessment of primary pain characteristics and management of opioid-induced constipation with a bowel regimen was significantly lower in African Americans than in Caucasian Americans. IMPLICATIONS FOR NURSING African American older adults receiving hospice care at the end of life received pain management that was, overall, comparable to matched Caucasian American older adults. Hospice and oncology nurses play a critical role in effective pain management and should continue to implement evidence-based guidelines for pain management into daily practice. Diffusing the hospice model and principles of pain and symptom management into other settings and specialty care areas may reduce widespread pain disparities.",2020,There were few statistically significant or clinically meaningful differences in implementation of individual best practices for pain management by race.,"['11 evidence-based cancer pain management strategies in a matched sample of patients in hospice', 'African American older adults receiving hospice care at the end of life', 'African Americans than in Caucasian Americans', 'matched Caucasian American older adults', 'Patients Receiving Hospice Care', '32 African American and 32 Caucasian American older adults (aged 65 years or older) with cancer pain receiving hospice care in the midwestern United States']",['pain management'],"['summative and individual Cancer Pain Practice Index scores', 'Pain Management']","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]",,0.0442802,There were few statistically significant or clinically meaningful differences in implementation of individual best practices for pain management by race.,"[{'ForeName': 'Staja Q', 'Initials': 'SQ', 'LastName': 'Booker', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Keela A', 'Initials': 'KA', 'LastName': 'Herr', 'Affiliation': 'University of Iowa.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Wilson Garvan', 'Affiliation': 'University of Florida.'}]",Oncology nursing forum,['10.1188/20.ONF.228-240'] 1128,31647470,Participant-Centered Online Active Surveillance for Adverse Events Following Vaccination in a Large Clinical Trial: Feasibility and Usability Study.,"BACKGROUND Active participant monitoring of adverse events following immunization (AEFI) is a recent development to improve the speed and transparency of vaccine safety postmarketing. Vaxtracker, an online tool used to monitor vaccine safety, has successfully demonstrated its usefulness in postmarketing surveillance of newly introduced childhood vaccines. However, its use in older participants, or for monitoring patients participating in large clinical trials, has not been evaluated. OBJECTIVE The objective of this study was to monitor AEFIs in older participants enrolled in the Australian Study for the Prevention through the Immunisation of Cardiovascular Events (AUSPICE) trial, and to evaluate the usefulness and effectiveness of Vaxtracker in this research setting. METHODS AUSPICE is a multicenter, randomized, placebo-controlled, double-blinded trial in which participants aged 55 to 61 years were given either the pneumococcal polysaccharide vaccine (23vPPV) or 0.9% saline placebo. Vaxtracker was used to monitor AEFIs in participants in either treatment arm through the administration of two online questionnaires. A link to each questionnaire was sent to participants via email or short message service (SMS) text message 7 and 28 days following vaccination. Data were collated and analyzed in near-real time to identify any possible safety signals indicating problems with the vaccine or placebo. RESULTS All 4725 AUSPICE participants were enrolled in Vaxtracker. Participant response rates for the first and final survey were 96.47% (n=4558) and 96.65% (n=4525), respectively. The online survey was completed by 90.23% (4083/4525) of Vaxtracker participants within 3 days of receiving the link. AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination. Dominant symptoms for vaccine and placebo recipients were pain at the injection site (587/2340, 25.09%) and fatigue (103/2332, 4.42%), respectively. Females were more likely to report symptoms following vaccination with 23vPPV compared with males (433/1138, 38.05% versus 372/1202, 30.95%; P<.001). CONCLUSIONS Vaxtracker is an effective tool for monitoring AEFIs in the 55 to 61 years age group. Participant response rates were high for both surveys, in both treatment arms and for each method of sending the survey. This study indicates that administration of 23vPPV was well-tolerated in this cohort. Vaxtracker has successfully demonstrated its application in the monitoring of adverse events in near-real time following vaccination in people participating in a national clinical trial. TRIAL REGISTRATION Australian New Zealand Trial Registry Number (ACTRN) 12615000536561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368506.",2019,AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination.,"['All 4725 AUSPICE participants were enrolled in Vaxtracker', 'older participants enrolled in the Australian Study for the Prevention through the Immunisation of Cardiovascular Events (AUSPICE) trial', 'participants aged 55 to 61 years', 'older participants, or for monitoring patients participating in large clinical trials']","['placebo', 'immunization (AEFI', 'pneumococcal polysaccharide vaccine (23vPPV) or 0.9% saline placebo', '23vPPV']","['AEFIs', 'Participant response rates', 'fatigue']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0305065', 'cui_str': 'Pneumococcal Polysaccharide Vaccine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.671419,AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination.,"[{'ForeName': 'Sally-Anne', 'Initials': 'SA', 'LastName': 'Munnoch', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cashman', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Roseanne', 'Initials': 'R', 'LastName': 'Peel', 'Affiliation': 'University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Hure', 'Affiliation': 'University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Durrheim', 'Affiliation': 'Hunter New England Local Health District, Wallsend, Australia.'}]",Journal of medical Internet research,['10.2196/14791'] 1129,31725441,Simulation-Based Team Leadership Training Improves Team Leadership During Actual Trauma Resuscitations: A Randomized Controlled Trial.,"OBJECTIVES Trauma resuscitations are complex critical care events that present patient safety-related risk. Simulation-based leadership training is thought to improve trauma care; however, there is no robust evidence supporting the impact of leadership training on clinical performance. The objective of this study was to assess the clinical impact of simulation-based leadership training on team leadership and patient care during actual trauma resuscitations. DESIGN Randomized controlled trial. SETTING Harborview Medical Center (level 1 trauma center). SUBJECTS Seventy-nine second- and third-year residents were randomized and 360 resuscitations were analyzed. INTERVENTIONS Subjects were randomized to a 4-hour simulation-based leadership training (intervention) or standard orientation (control) condition. MEASUREMENTS AND MAIN RESULTS Participant-led actual trauma resuscitations were video recorded and coded for leadership behaviors and patient care. We used random coefficient modeling to account for the nesting effect of multiple observations within residents and to test for post-training group differences in leadership behaviors while controlling for pre-training behaviors, Injury Severity Score, postgraduate training year, and days since training occurred. Sixty participants completed the study. There was a significant difference in post-training leadership behaviors between the intervention and control conditions (b1 = 4.06, t (55) = 6.11, p < 0.001; intervention M = 11.29, SE = 0.66, 95% CI, 9.99-12.59 vs control M = 7.23, SE = 0.46, 95% CI, 6.33-8.13, d = 0.92). Although patient care was similar between conditions (b = 2.00, t (55) = 0.99, p = 0.325; predicted means intervention M = 62.38, SE = 2.01, 95% CI, 58.43-66.33 vs control M = 60.38, SE = 1.37, 95% CI, 57.69-63.07, d = 0.15), a test of the mediation effect between training and patient care suggests leadership behaviors mediate an effect of training on patient care with a significant indirect effect (b = 3.44, 95% CI, 1.43-5.80). Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001). CONCLUSIONS Leadership training resulted in the transfer of complex skills to the clinical environment and may have an indirect effect on patient care through better team leadership.",2020,"Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001). ","['Harborview Medical Center (level 1 trauma center', 'Sixty participants completed the study', 'Seventy-nine second- and third-year residents were randomized and 360 resuscitations were analyzed']","['4-hour simulation-based leadership training (intervention) or standard orientation (control) condition', 'Simulation-based leadership training', 'Simulation-Based Team Leadership Training Improves Team Leadership', 'leadership training', 'simulation-based leadership training', 'Leadership training']",['post-training leadership behaviors'],"[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",60.0,0.142068,"Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001). ","[{'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Fernandez', 'Affiliation': 'Center for Experiential Learning and Simulation, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, FL.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Rosenman', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Olenick', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Misisco', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Brolliar', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Chipman', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Vrablik', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Kalynych', 'Affiliation': 'Department of Emergency Medicine, Office of Educational Affairs, University of Florida College of Medicine - Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Arbabi', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, WA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD.'}, {'ForeName': 'Steve W J', 'Initials': 'SWJ', 'LastName': 'Kozlowski', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Georgia T', 'Initials': 'GT', 'LastName': 'Chao', 'Affiliation': 'Department of Management, Michigan State University, East Lansing, MI.'}]",Critical care medicine,['10.1097/CCM.0000000000004077'] 1130,31029230,"Effect of a behaviour change intervention on the quality of peri-urban sanitation in Lusaka, Zambia: a randomised controlled trial.","BACKGROUND Poor sanitation in peri-urban areas is a growing public health problem. We tested a scalable, demand-side behaviour change intervention to motivate landlords to improve the quality of shared toilets within their plots. METHODS We did a residential plot-randomised controlled trial in a peri-urban community in Lusaka, Zambia. We enrolled adult resident landlords on plots where at least one tenant lived. We allocated landlords 1:1 to intervention and control arms on the basis of a random number sequence. The intervention was developed using the Behaviour Centred Design approach and consisted of a series of group meetings designed to motivate sanitation quality improvement as a way to build wealth and reduce on-plot conflict; no subsidies or materials were provided. The control group received no intervention. The four primary outcomes were having a rotational cleaning system in place (to improve hygiene); having a solid door on the toilet used by tenants with an inside lock (for privacy); having an outside lock (for security); and having a sealed toilet (to reduce smell and contamination). We measured outcomes 1 month before the start of the intervention and 4 months after the end of the intervention. Data collectors measuring outcomes were blinded to group assignment. We analysed outcomes by intention to treat, including all landlords with study-end results. Because the outcomes were assumed to not be independent, we used a family-wise error rate of 0·05 to calculate an adjusted significance level of 0·0253. This study was registered with ClinicalTrials.gov, number NCT03174015. FINDINGS Between June 9 and July 6, 2017, 1085 landlords were enrolled and randomly assigned to the intervention (n=543) or the control group (n=542). The intervention was delivered from Aug 1, 2017, and evaluated from Feb 15 to March 5, 2018. Analysis was based on the 474 intervention and 454 control landlords surveyed at study end. The intervention was associated with improvements in the prevalence of cleaning rotas (relative risk 1·16, 95% CI 1·05-1·30; p=0·0011), inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063). INTERPRETATION It is possible to improve the structural quality and cleanliness of shared sanitation by targeting landlords with a scalable, theory-driven behaviour change intervention without subsidy or provision of the relevant infrastructure. FUNDING Sanitation and Hygiene Applied Research for Equity.",2019,"inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063). ","['peri-urban sanitation in Lusaka, Zambia', 'Between June 9 and July 6, 2017, 1085 landlords were enrolled and randomly assigned to the intervention (n=543) or the control group (n=542', 'peri-urban community in Lusaka, Zambia']","['behaviour change intervention', 'no intervention']","['rotational cleaning system in place (to improve hygiene); having a solid door on the toilet used by tenants with an inside lock (for privacy); having an outside lock (for security); and having a sealed toilet (to reduce smell and contamination', 'prevalence of cleaning rotas']","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}, {'cui': 'C1140607', 'cui_str': 'Toilets'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",1085.0,0.115879,"inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063). ","[{'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Tidwell', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel St, London, UK. Electronic address: ben.tidwell@lshtm.ac.uk.'}, {'ForeName': 'Jenala', 'Initials': 'J', 'LastName': 'Chipungu', 'Affiliation': 'Center for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bosomprah', 'Affiliation': 'Center for Infectious Disease Research in Zambia, Lusaka, Zambia; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Aunger', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel St, London, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Curtis', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel St, London, UK.'}, {'ForeName': 'Roma', 'Initials': 'R', 'LastName': 'Chilengi', 'Affiliation': 'Center for Infectious Disease Research in Zambia, Lusaka, Zambia.'}]",The Lancet. Planetary health,['10.1016/S2542-5196(19)30036-1'] 1131,31695168,Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder.,"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear. It is also unclear whether functional connectivity can be used as a predictive biomarker of treatment response. Here, we used whole-brain functional connectivity analysis to identify neural signatures of remission following antidepressant treatment, and to identify connectomic predictors of treatment response. 163 MDD and 62 healthy individuals underwent functional MRI during pre-treatment baseline and 8-week follow-up sessions. Patients were randomized to escitalopram, sertraline or venlafaxine-XR antidepressants and assessed at follow-up for remission. Baseline measures of intrinsic functional connectivity between each pair of 333 regions were analyzed to identify pre-treatment connectomic features that distinguish remitters from non-remitters. We then interrogated these connectomic differences to determine if they changed post-treatment, distinguished patients from controls, and were modulated by medication type. Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks. This baseline hypo-connectivity for non-remitters also distinguished them from controls and increased following treatment. In contrast, connectivity for remitters was higher than controls at baseline and also following remission, suggesting a trait-like connectomic characteristic. Increased functional connectivity within and between large-scale intrinsic brain networks may characterize acute recovery with antidepressants in depression.",2020,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.",['163 MDD and 62 healthy individuals underwent'],"['escitalopram, sertraline or venlafaxine-XR antidepressants', 'functional MRI']","['connectivity for remitters', 'intrinsic functional connectivity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",163.0,0.0349942,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.","[{'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. m.korgaonkar@sydney.edu.au.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fornito', 'Affiliation': 'Brain and Mental Health Research Hub, Turner Institute for Brain and Mental Health & Monash Biomedical Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. leawilliams@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0574-2'] 1132,30851442,Efficacy and Safety of Ceritinib (450 mg/d or 600 mg/d) With Food Versus 750-mg/d Fasted in Patients With ALK Receptor Tyrosine Kinase (ALK)-Positive NSCLC: Primary Efficacy Results From the ASCEND-8 Study.,"INTRODUCTION In an earlier report of the ASCEND-8 study (open-label, phase I, three-arm study, treatment-naive patients and pre-treated patients with advanced/metastatic NSCLC), it was shown that ceritinib 450 mg with food had comparable exposure and better gastrointestinal tolerability than 750-mg fasted. METHODS Here, we report efficacy and updated safety data from primary efficacy analysis of the ASCEND-8 study. Key secondary endpoints were overall response rate and duration of response, assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors 1.1. RESULTS In total, 306 patients were randomized to ceritinib 450-mg fed (n = 108) or 600-mg fed (n = 87) or 750-mg fasted (n = 111), of which 304 patients were included in safety analysis and 198 treatment-naive patients (ALK receptor tyrosine kinase [ALK]-positive by immunohistochemistry) were included in the efficacy analysis (450-mg fed [n = 73], 600-mg fed [n = 51], and 750-mg fasted [n = 74]). The BIRC-assessed overall response rate was 78.1% (95% confidence interval [CI]: 66.9-86.9), 72.5% (95% CI: 58.3-84.1), and 75.7% (95% CI: 64.3-84.9), respectively; and the median duration of response (months) by BIRC was not estimable (NE) (95% CI: 11.2-NE), 20.7 (95% CI: 15.8-NE), and 15.4 (95% CI: 8.3-NE), respectively. Based on the safety analysis (n = 304), the 450-mg fed arm showed the highest median relative dose intensity (100% versus 78.5% versus 83.7%), lowest proportion of patients with dose reductions (24.1% versus 65.1% versus 60.9%), and lowest proportion of patients with gastrointestinal toxicities (75.9% versus 82.6% versus 91.8%). CONCLUSION Ceritinib at a dose of 450 mg with food compared to 750-mg fasted showed consistent efficacy and less gastrointestinal toxicity.",2019,"The BIRC-assessed overall response rate was 78.1% (95% confidence interval [CI]: 66.9-86.9), 72.5% (95% CI: 58.3-84.1), and 75.7% (95% CI: 64.3-84.9), respectively; and the median duration of response (months) by BIRC was not estimable (NE) (95% CI: 11.2-NE), 20.7 (95% CI: 15.8-NE), and 15.4 (95% CI: 8.3-NE), respectively.","['naive patients and pre-treated patients with advanced/metastatic NSCLC', '306 patients were randomized to ceritinib 450-mg fed (n\xa0= 108) or 600-mg fed (n\xa0= 87) or 750-mg fasted (n\xa0= 111), of which 304 patients were included in safety analysis and 198 treatment-naive patients (ALK receptor tyrosine kinase [ALK]-positive by immunohistochemistry) were included in the efficacy analysis (450-mg fed [n\xa0= 73], 600-mg fed [n\xa0= 51], and 750-mg fasted [n\xa0= 74']","['ALK Receptor Tyrosine Kinase (ALK)-Positive NSCLC', 'Ceritinib (450 mg/d or 600 mg/d']","['gastrointestinal toxicity', 'BIRC-assessed overall response rate', 'overall response rate and duration of response, assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors 1.1', 'gastrointestinal tolerability', 'gastrointestinal toxicities', 'highest median relative dose intensity', 'Efficacy and Safety', 'median duration of response (months) by BIRC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C3818721', 'cui_str': 'ceritinib'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3818721', 'cui_str': 'ceritinib'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",306.0,0.217461,"The BIRC-assessed overall response rate was 78.1% (95% confidence interval [CI]: 66.9-86.9), 72.5% (95% CI: 58.3-84.1), and 75.7% (95% CI: 64.3-84.9), respectively; and the median duration of response (months) by BIRC was not estimable (NE) (95% CI: 11.2-NE), 20.7 (95% CI: 15.8-NE), and 15.4 (95% CI: 8.3-NE), respectively.","[{'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: CBC1971@yuhs.ac.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Obermannova', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno-střed-Staré Brno, Czech Republic.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bearz', 'Affiliation': 'Centro di Riferimento Oncologico-IRCCS, Aviano, Italy.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McKeage', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Dong-Wang', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ullas', 'Initials': 'U', 'LastName': 'Batra', 'Affiliation': 'Rajiv Gandhi Cancer Institute, Rohini, New Delhi, India.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Borra', 'Affiliation': 'Az. Osp. Univ.Maggiore della Carità, Italy.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Orlov', 'Affiliation': 'State Pavlov Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sarayut L', 'Initials': 'SL', 'LastName': 'Geater', 'Affiliation': 'Songklanagarind Hospital, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Pieter E', 'Initials': 'PE', 'LastName': 'Postmus', 'Affiliation': 'The Clatterbridge Centre NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Laurie', 'Affiliation': 'Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Yang', 'Affiliation': 'Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ardizzoni', 'Affiliation': 'S.Orsola-Malpighi University Hospital, Bologna, Italy.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Bettini', 'Affiliation': 'A.S.S.T. Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Kiertsman', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yvonne Y', 'Initials': 'YY', 'LastName': 'Lau', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Kalyanee', 'Initials': 'K', 'LastName': 'Viraswami-Appanna', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Vanessa Q', 'Initials': 'VQ', 'LastName': 'Passos', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Dziadziuszko', 'Affiliation': 'Rafal Dziadziuszko, Medical University of Gdansk, Gdansk, Poland.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.03.002'] 1133,31021313,"The impact of content, frame and social identity on the effectiveness of smoking cessation messages in urban young adults.","The current study examined the impact of health versus economic content, as well as gain versus loss frame, in smoking cessation intervention messages on intention, motivation, and planning to quit smoking. Gender, race, Socioeconomic Status (SES), nicotine dependence, and smoker identity variables were investigated as moderators of the relationship between message content and outcomes. Self-identified smokers were randomly assigned to read a gain or loss framed message with economic or health content. Intention, motivation, and planning to quit smoking were measured before and after message exposure. Results showed average gains in intention, motivation, and planning to quit smoking, regardless of message received. However, change in motivation and intention was greater for participants exposed to the economic message. There were no effects of message frame. Years of smoking and race moderated the effects of message content on intention and motivation. Implications for developing tailored messages for smoking cessation in young adults are discussed.",2019,There were no effects of message frame.,"['urban young adults', 'young adults', 'Self-identified smokers']",['read a gain or loss framed message with economic or health content'],"['intention, motivation, and planning to quit smoking', 'average gains in intention, motivation, and planning to quit smoking, regardless of message received', 'Intention, motivation, and planning to quit smoking', 'Gender, race, Socioeconomic Status (SES), nicotine dependence, and smoker identity variables', 'motivation and intention']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.0220499,There were no effects of message frame.,"[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Shevorykin', 'Affiliation': 'a Department of Psychology and Mental Health Counseling , Pace University , Pleasantville , New York , USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Yali', 'Affiliation': 'b Department of Psychology , The City College of New York , New York , USA.'}]",Journal of prevention & intervention in the community,['10.1080/10852352.2019.1603677'] 1134,31725692,Impact of Preoperative Acetaminophen and Carbohydrate Loading on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Nonmelanoma Skin Cancers.,"BACKGROUND Preoperative acetaminophen and carbohydrate loading has been shown to improve the functional recovery of surgical patients. OBJECTIVE To determine the effects of preoperative acetaminophen and carbohydrates on functional outcomes and the use of pain medications after surgery in patients undergoing Mohs Micrographic Surgery (MMS) for nonmelanoma skin cancer (NMSC). MATERIALS AND METHODS One hundred patients treated with MMS for NMSC at an academic center were randomized into a control group receiving standard preoperative care or an intervention group receiving acetaminophen and carbohydrate drinks immediately before surgery. Patients rated levels of pain, thirst, hunger, anxiety, and fatigue on the day of surgery on a scale of 0 to 100, and reported through a phone interview the use of pain medications within 48 hours of surgery. RESULTS There was no significant difference between intervention and control groups in maximum pain score on the day of surgery; maximum pain score 48 hours after surgery; use of nonopioid pain medications; and use of opioids. However, the intervention group had lower anxiety levels during and at the end of surgery. CONCLUSION Patients undergoing MMS for NMSC reported very low levels of pain during and after surgery. Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.",2020,Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.,"['patients undergoing Mohs Micrographic Surgery (MMS) for nonmelanoma skin cancer (NMSC', 'One hundred patients treated with MMS for NMSC at an academic center', 'Patients Undergoing Mohs Micrographic Surgery for Nonmelanoma Skin Cancers']","['Preoperative Acetaminophen and Carbohydrate Loading', 'preoperative acetaminophen and carbohydrates', 'control group receiving standard preoperative care or an intervention group receiving acetaminophen and carbohydrate drinks immediately before surgery', 'acetaminophen and carbohydrate loading', 'Preoperative acetaminophen and carbohydrate loading']","['levels of pain, thirst, hunger, anxiety, and fatigue', 'lower anxiety levels', 'maximum pain score', 'pain levels', 'Pain and Functional Status', 'levels of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4277655', 'cui_str': 'Diet, Carbohydrate Loading'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033061', 'cui_str': 'Preoperative Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",100.0,0.0310906,Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Aleisa', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Naccarato', 'Affiliation': 'Department of Dermatology, Tufts School of Medicine, Department of Dermatology, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Gramz', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jalak', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Bichchau', 'Initials': 'B', 'LastName': 'Nguyen', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002161'] 1135,28870461,Enhanced plasmacytoid dendritic cell antiviral responses after omalizumab.,"BACKGROUND Atopy and viral respiratory tract infections synergistically promote asthma exacerbations. IgE cross-linking inhibits critical virus-induced IFN-α responses of plasmacytoid dendritic cells (pDCs), which can be deficient in patients with allergic asthma. OBJECTIVE We sought to determine whether reducing IgE levels in vivo with omalizumab treatment increases pDC antiviral IFN-α responses in inner-city children with asthma. METHODS PBMCs and pDCs isolated from children with exacerbation-prone asthma before and during omalizumab treatment were stimulated ex vivo with rhinovirus and influenza in the presence or absence of IgE cross-linking. IFN-α levels were measured in supernatants, and mRNA expression of IFN-α pathway genes was determined by using quantitative RT-PCR (qRT-PCR) in cell pellets. FcεRIα protein levels and mRNA expression were measured in unstimulated cells by using flow cytometry and qRT-PCR, respectively. Changes in these outcomes and associations with clinical outcomes were analyzed, and statistical modeling was used to identify risk factors for asthma exacerbations. RESULTS Omalizumab treatment increased rhinovirus- and influenza-induced PBMC and rhinovirus-induced pDC IFN-α responses in the presence of IgE cross-linking and reduced pDC surface FcεRIα expression. Omalizumab-induced reductions in pDC FcεRIα levels were significantly associated with a lower asthma exacerbation rate during the outcome period and correlated with increases in PBMC IFN-α responses. PBMC FcεRIα mRNA expression measured on study entry significantly improved an existing model of exacerbation prediction. CONCLUSIONS These findings indicate that omalizumab treatment augments pDC IFN-α responses and attenuates pDC FcεRIα protein expression and provide evidence that these effects are related. These results support a potential mechanism underlying clinical observations that allergic sensitization is associated with increased susceptibility to virus-induced asthma exacerbations.",2018,Omalizumab-induced reductions in pDC FcεRIα levels were significantly associated with a lower asthma exacerbation rate during the outcome period and correlated with increases in PBMC IFN-α responses.,"['inner-city children with asthma', 'patients with allergic asthma', 'children with exacerbation-prone asthma before and during omalizumab treatment were stimulated ex\xa0vivo with rhinovirus and influenza in the presence or absence of IgE cross-linking']","['omalizumab treatment', 'omalizumab']","['plasmacytoid dendritic cell antiviral responses', 'rhinovirus- and influenza-induced PBMC and rhinovirus-induced pDC IFN-α responses', 'IFN-α levels', 'asthma exacerbation rate', 'pDC FcεRIα levels', 'PBMC IFN-α responses', 'pDC IFN-α responses', 'pDC antiviral IFN-α responses', 'PBMC FcεRIα mRNA expression', 'FcεRIα protein levels and mRNA expression']","[{'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035473', 'cui_str': 'Rhinovirus'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1956385', 'cui_str': 'Plasmacytoid Dendritic Cells'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0035473', 'cui_str': 'Rhinovirus'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",,0.0417648,Omalizumab-induced reductions in pDC FcεRIα levels were significantly associated with a lower asthma exacerbation rate during the outcome period and correlated with increases in PBMC IFN-α responses.,"[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Gill', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex; Department of Internal Medicine, Division of Allergy & Immunology, University of Texas Southwestern Medical Center, Dallas, Tex. Electronic address: Michelle.Gill@UTSouthwestern.edu.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Liu', 'Affiliation': ""Children's Hospital Colorado and the Department of Pediatrics, Division of Pulmonary Medicine, University of Colorado School of Medicine, Aurora, Colo.""}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Calatroni', 'Affiliation': 'Rho, Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Rebecca Z', 'Initials': 'RZ', 'LastName': 'Krouse', 'Affiliation': 'Rho, Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Baomei', 'Initials': 'B', 'LastName': 'Shao', 'Affiliation': 'Department of Internal Medicine, Division of Allergy & Immunology, University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Schiltz', 'Affiliation': ""Children's Hospital Colorado and the Department of Pediatrics, Division of Pulmonary Medicine, University of Colorado School of Medicine, Aurora, Colo.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Gern', 'Affiliation': 'Department of Medicine, Division of Allergy & Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Alkis', 'Initials': 'A', 'LastName': 'Togias', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Department of Medicine, Division of Allergy & Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2017.07.035'] 1136,31021304,Reducing inhalant use in Latino adolescents through synchronized parent-adolescent interventions.,"This article presents the effects of a synchronized Latino youth/parent intervention on adolescent inhalant use. The analytic sample included only Latino adolescents ( n  = 487) between the ages of 12 and 14. Randomized at the school-level, the design included three possible conditions: (1) child and parent received the prevention interventions, (2) only the parent received the prevention intervention, (3) neither child or parent received the prevention interventions. Drawing from the eco-developmental perspective, the overall hypothesis was that youth randomly assigned to the condition with both interventions will report the strongest inhalant use prevention outcomes. Descriptive statistics and regression tests of significant group differences by treatment condition confirmed the overall hypothesis. Children receiving the youth intervention and whose parents received the synchronized parenting intervention reported the strongest desired inhalant prevention effects. The findings are interpreted from an eco-developmental perspective and implications for practice, policy, and future research are discussed.",2019,Children receiving the youth intervention and whose parents received the synchronized parenting intervention reported the strongest desired inhalant prevention effects.,"['Latino adolescents through synchronized parent-adolescent interventions', 'Latino adolescents ( n \u2009=\u2009487) between the ages of 12 and 14']","['synchronized parenting intervention', 'prevention interventions, (2) only the parent received the prevention intervention, (3) neither child or parent received the prevention interventions', 'synchronized Latino youth/parent intervention']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],487.0,0.0173387,Children receiving the youth intervention and whose parents received the synchronized parenting intervention reported the strongest desired inhalant prevention effects.,"[{'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'a Southwest Interdisciplinary Research Center, School of Social Work , Arizona State University , Phoenix , Arizona , USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'a Southwest Interdisciplinary Research Center, School of Social Work , Arizona State University , Phoenix , Arizona , USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kiehne', 'Affiliation': 'a Southwest Interdisciplinary Research Center, School of Social Work , Arizona State University , Phoenix , Arizona , USA.'}]",Journal of prevention & intervention in the community,['10.1080/10852352.2019.1603675'] 1137,31021404,"The conventional protocol vs. a protocol including illumination with a fabric-based biophotonic device (the Phosistos protocol) in photodynamic therapy for actinic keratosis: a randomized, controlled, noninferiority clinical study.","BACKGROUND Topical photodynamic therapy (PDT) using methyl aminolaevulinate is a noninvasive treatment option suitable to treat clinical and subclinical actinic keratosis (AK) over a large area (field cancerization). The most widely used, conventional protocol in Europe includes illumination with a red-light lamp. This illumination commonly causes pain, and patients often cannot complete the treatment. OBJECTIVES The aims of this paper are twofold. The first aim is to introduce a novel protocol, the Phosistos protocol (P-PDT), which includes illumination with a fabric-based biophotonic device. The second and major aim is to assess the noninferiority, in terms of efficacy for PDT of AK, of P-PDT compared with the conventional protocol (C-PDT). METHODS A randomized, controlled, multicentre, intraindividual clinical study was conducted. Forty-six patients with grade I-II AK of the forehead and scalp were treated with P-PDT on one area (280 AK lesions) and with C-PDT on the contralateral area (280 AK lesions). The primary end point was the lesion complete response (CR) rate at 3 months, with an absolute noninferiority margin of -10%. Secondary end points included pain scores, incidence of adverse effects and cosmetic outcome. RESULTS Three months following treatment, the lesion CR rate of P-PDT was noninferior to that of C-PDT (79·3% vs. 80·7%, respectively; absolute difference -1·6%; one-sided 95% confidence interval -4·5% to infinity). The noninferiority of P-PDT to C-PDT in terms of the lesion CR rate remained at the 6-month follow-up (94·2% vs. 94·9%, respectively; absolute difference -0·6%; one-sided 95% confidence interval -2·7% to infinity). Moreover, the pain score at the end of illumination was significantly lower for P-PDT than for C-PDT (mean ± SD 0·3 ± 0·6 vs. 7·4 ± 2·3; P < 0·001). CONCLUSIONS P-PDT is noninferior to C-PDT in terms of efficacy for treating AK of the forehead and scalp and resulted in much lower pain scores and fewer adverse effects. What's already known about this topic? Topical photodynamic therapy using methyl aminolaevulinate is effective for treating actinic keratosis. In Europe, the conventional protocol involves illumination with a red-light lamp. Unfortunately, pain is often experienced by patients undergoing this protocol. An alternative protocol that uses daylight illumination has recently been shown to be as effective as the conventional protocol while being nearly painless. However, this alternative protocol can be conducted only in suitable weather conditions. What does this study add? The Phosistos protocol is demonstrated to be as effective as the conventional protocol, nearly as painless as the daylight protocols and suitable year round for treatment of actinic keratosis.",2020,"Three months following treatment, the lesion CR rate of P-PDT was non-inferior to that of C-PDT (79.3% vs. 80.7%, respectively; absolute difference, -1.6%; one-sided 95% confidence interval, -4.5% to infinity).","['Forty-six patients with grade I-II AK of the forehead and scalp were treated with P-PDT on one area (n=280 AK lesions) and with C-PDT on the contralateral area (n=280 AK lesions', 'actinic keratosis']","['conventional protocol versus a protocol including illumination with a fabric-based biophotonic device', 'photodynamic therapy', 'Topical photodynamic therapy (PDT) using methyl aminolevulinate']","['lesion CR rate of P-PDT', 'lesion complete response (CR) rate', 'pain scores, incidence of adverse effects and cosmetic outcome', 'pain scores', 'pain score', 'lesion CR rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1964256', 'cui_str': 'Illumination - action'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1134467', 'cui_str': 'methyl aminolevulinate'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}]",46.0,0.137662,"Three months following treatment, the lesion CR rate of P-PDT was non-inferior to that of C-PDT (79.3% vs. 80.7%, respectively; absolute difference, -1.6%; one-sided 95% confidence interval, -4.5% to infinity).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mordon', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Vignion-Dewalle', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Abi-Rached', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thecua', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lecomte', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vicentini', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Deleporte', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Béhal', 'Affiliation': 'University of Lille, CHU Lille, EA 2694 - Santé Publique: Epidémiologie et Qualité des Soins, Unité de Biostatistiques, F-59000, Lille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kerob', 'Affiliation': 'Galderma International SAS, F-92927, La Défense, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hommel', 'Affiliation': 'Department of Dermatology and Allergology, Klinikum Vest GmbH, D-45657, Recklinghausen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'University of Lille, CHU Lille, EA 2694 - Santé Publique: Epidémiologie et Qualité des Soins, Unité de Biostatistiques, F-59000, Lille, France.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Szeimies', 'Affiliation': 'Department of Dermatology and Allergology, Klinikum Vest GmbH, D-45657, Recklinghausen, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'University of Lille, INSERM, CHU Lille, U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, F-59000, Lille, France.'}]",The British journal of dermatology,['10.1111/bjd.18048'] 1138,31541874,Peripheral proinflammatory markers are upregulated in abstinent alcohol-dependent patients but are not affected by cognitive bias modification: Preliminary findings.,"BACKGROUND Inflammatory pathways are known to be negatively affected in patients with alcohol use disorder (AUD). Cognitive bias modification (CBM), an emerging behavioral treatment that involves the 're-training' of cognitive biases using computerized tasks, has been reported to reduce alcohol craving and relapse rates. The aim of this study was to compare peripheral concentrations of the proinflammatory biomarkers IL-18, IL-6, IL-1β, TNF-α and CRP in AUD patients versus controls and to identify whether CBM treatment affected these biomarkers in AUD patients. METHODS This 3-week double-blind randomized controlled study tested 36 male abstinent AUD patients receiving CBM or placebo-training, who were also compared to 18 male healthy controls. The approach avoidance task (AAT) was used to test the AUD patients before and after training. CBM training took place over 6 sessions, using a joystick-based approach-avoidance task. Blood samples were collected after the pre- and post-AAT test sessions for the AUD groups, and during an outpatient appointment with the controls. RESULTS AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031). No changes in the CBM versus placebo groups were noted in IL-18, TNF-α and CRP concentrations following pre-post change or within group pretest- posttest analysis. IL-6 and IL-1β levels fell under the lower detection limit, thus were not included in the final analyses. CONCLUSIONS This study confirms that the inflammatory system is altered in AUD. This was the first study that investigated whether CBM training affected proinflammatory markers in AUD patients.",2019,"RESULTS AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031).","['AUD patients', '18 male healthy controls', 'patients with alcohol use disorder (AUD', '36 male abstinent AUD patients receiving']","['CBM', 'IL-6', 'CBM training', 'placebo', 'Cognitive bias modification (CBM', 'CBM or placebo-training']","['IL-18, TNF-α and CRP concentrations', 'proinflammatory markers', 'peripheral concentrations of the proinflammatory biomarkers IL-18, IL-6, IL-1β, TNF-α and CRP', 'Blood samples', 'alcohol craving and relapse rates', 'Peripheral proinflammatory markers', 'plasma levels of TNF- α']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",18.0,0.108888,"RESULTS AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031).","[{'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Portelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Corinde E', 'Initials': 'CE', 'LastName': 'Wiers', 'Affiliation': 'Laboratory of Neuroimaging, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Deschaine', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Gray R', 'Initials': 'GR', 'LastName': 'McDiarmid', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bermpohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Germany; Berlin School of Mind and Brain, Humboldt Universität zu Berlin, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, USA; Center for Alcohol and Addiction Studies, Brown University, Providence, RI, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107553'] 1139,30676482,Effect of continuous positive airway pressure in patients with true refractory hypertension and sleep apnea: a post-hoc intention-to-treat analysis of the HIPARCO randomized clinical trial.,"RATIONALE Continuous positive airway pressure (CPAP) can significantly reduce blood pressure (BP) levels in patients with resistant hypertension and sleep apnea (OSA); however, the effect on patients with refractory hypertension (RfH) is not known. This study seeks to evaluate the effect of CPAP treatment on BP levels in patients with OSA and RfH, compared with those with OSA and resistant hypertension. METHODS Post-hoc analysis of the HIPARCO randomized clinical trial on the effect of CPAP treatment on BP levels in patients with resistant hypertension. Those patients with uncontrolled 24-h ambulatory BP monitoring readings (>130 and/or >80 mmHg) in SBP or DBP were considered to have resistant hypertension (if they were taking three or four antihypertensive drugs) or RfH (if they were taking at least five drugs). OSA patients were randomized to receive CPAP or usual care for 3 months. They underwent a second 24-h ambulatory BP monitoring study to establish the effect of CPAP treatment on BP levels in both groups. RESULTS A total of 98 patients were randomized to CPAP (19 RfH/79 resistant hypertension) and 96 to usual care (21 RfH/75 resistant hypertension). BP readings dropped more marked in patients with RfH than resistant hypertension, in both 24-h SBP (-9 vs. -1.6 mmHg, P = 0.021) and 24-h DBP (-7.3 vs. -2.3 mmHg, P = 0.074), especially at night (-11.3 vs. -3.8, P = 0.121 and -8.8 vs. -2.2, P = 0.054) respectively. Adjusted difference between groups was statistically significant in 24-h SBP levels (-7.4 mmHg, P = 0.021). CONCLUSION CPAP lowers BP levels in both resistant hypertension and RfH patients although the degree of this reduction is higher in those with RfH especially during the night.",2019,"Adjusted difference between groups was statistically significant in 24-h SBP levels (-7.4 mmHg, P = 0.021). ","['98 patients', 'patients with OSA and RfH, compared with those with OSA and resistant hypertension', 'Those patients with uncontrolled 24-h ambulatory BP monitoring readings (>130 and/or >80\u200ammHg) in SBP or DBP were considered to have resistant hypertension (if they were taking three or four antihypertensive drugs) or RfH (if they were taking at least five drugs', 'patients with resistant hypertension', 'patients with refractory hypertension (RfH', 'patients with true refractory hypertension and sleep apnea', 'OSA patients', '19 RfH/79 resistant hypertension) and 96 to usual care (21 RfH/75 resistant hypertension', 'patients with resistant hypertension and sleep apnea (OSA']","['Continuous positive airway pressure (CPAP', 'CPAP', 'continuous positive airway pressure']","['BP readings', '24-h DBP', '24-h SBP levels', 'blood pressure (BP) levels', 'CPAP lowers BP levels', 'BP levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205449', 'cui_str': 'Three'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0860493', 'cui_str': 'Blood pressure increased refractory'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",98.0,0.0621344,"Adjusted difference between groups was statistically significant in 24-h SBP levels (-7.4 mmHg, P = 0.021). ","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Navarro-Soriano', 'Affiliation': 'Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia.'}, {'ForeName': 'Miguel-Angel', 'Initials': 'MA', 'LastName': 'Martínez-García', 'Affiliation': 'Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Torres', 'Affiliation': 'Internal Medicine Service, Hospital Universitari de Santa María.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'Institut de Recerca Biomédica, IRB Lleida, Lleida.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero-Eraso', 'Affiliation': 'Respiratory Department, Hospital Universitario Virgen del Rocío, Institute of Biomedicine of Seville (IBiS), Seville.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lloberes', 'Affiliation': 'Respiratory Department, Hospital Universitario Vall Hebrón, Barcelona.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Diaz Cambriles', 'Affiliation': 'Respiratory Department, Hospital Universitario 12 de Octubre, Madrid.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Somoza', 'Affiliation': 'Respiratory Department, Consorcio Sanitario de Terrassa, Barcelona.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, Hospital Universitario San Pedro de Alcántara, Cáceres.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mañas', 'Affiliation': 'Respiratory Department, Hospital Universitario Ramón y Cajal, Madrid.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'de la Peña', 'Affiliation': 'Respiratory Department, Hospital Universitario Son Espases, Palma de Mallorca.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'García-Río', 'Affiliation': 'Respiratory Department, Hospital Universitario La Paz, IdiPAZ, Madrid.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Montserrat', 'Affiliation': 'Respiratory Department, Hospital Clinic-IDIBAPS, Barcelona.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Muriel', 'Affiliation': 'Biostatistic Unit, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Oscullo', 'Affiliation': 'Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Feced Olmos', 'Affiliation': 'Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'García-Ortega', 'Affiliation': 'Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Calhoun', 'Affiliation': 'Vascular Biology and Hypertension Program, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Campos-Rodriguez', 'Affiliation': 'Respiratory Department, Hospital Universitario ValmE, Institute of Biomedicine of Seville (IBiS), Seville.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hypertension,['10.1097/HJH.0000000000002053'] 1140,31017851,Individual Versus Small Group Treatment of Morphological Errors for Children With Developmental Language Disorder.,"Purpose This study examines the effects of enhanced conversational recast for treating morphological errors in preschoolers with developmental language disorder. The study assesses the effectiveness of this treatment in an individual or group ( n = 2) setting and the possible benefits of exposing a child to his or her partner's treatment target in addition to his or her own. Method Twenty children were assigned to either an individual ( n = 10) or group ( n = 10, 2 per group) condition. Each child received treatment for 1 morpheme (the target morpheme) for approximately 5 weeks. Children in the group condition had a different target from their treatment partner. Pretreatment and end treatment probes were used to compare correct usage of the target morpheme and a control morpheme. For children in the group condition, the correct usage of their treatment partner's target morpheme was also examined. Results Significant treatment effects occurred for both treatment conditions only for morphemes treated directly (target morpheme). There was no statistically significant difference between the treatment conditions at the end of treatment or at follow-up. Children receiving group treatment did not demonstrate significant gains in producing their partner's target despite hearing the target modeled during treatment. Conclusions This study provides the evidence base for enhanced conversational recast treatment in a small group setting, a treatment used frequently in school settings. Results indicate the importance of either attention to the recast or expressive practice (or both) to produce gains with this treatment. Supplemental Material https://doi.org/10.23641/asha.7859975.",2019,Children receiving group treatment did not demonstrate significant gains in producing their partner's target despite hearing the target modeled during treatment.,"['Children', 'preschoolers with developmental language disorder']","['enhanced conversational recast', 'Supplemental Material https://doi.org/10.23641/asha.7859975']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023014', 'cui_str': 'Speech or Language, Developmental Disorder'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",[],20.0,0.0152889,Children receiving group treatment did not demonstrate significant gains in producing their partner's target despite hearing the target modeled during treatment.,"[{'ForeName': 'Sunniva S', 'Initials': 'SS', 'LastName': 'Eidsvåg', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Norway.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Plante', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Trianna', 'Initials': 'T', 'LastName': 'Oglivie', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Privette', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Marja-Liisa', 'Initials': 'ML', 'LastName': 'Mailend', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}]","Language, speech, and hearing services in schools",['10.1044/2018_LSHSS-18-0033'] 1141,31607143,Effects of Intensive Versus Standard Ambulatory Blood Pressure Control on Cerebrovascular Outcomes in Older People (INFINITY).,"BACKGROUND Subcortical microvascular disease represented by brain white matter hyperintensity on magnetic resonance imaging is associated with functional decline in older people with hypertension. The effects of 2 levels of 24-hour average systolic blood pressure (BP) on mobility, white matter disease progression, and cognitive function over 3 years were studied. METHODS This trial was a prospective, randomized, blinded end-points study in patients ≥75 years of age with systolic hypertension and magnetic resonance imaging evidence of white matter hyperintensity lesions. Patients were randomized to a 24-hour mean systolic BP of ≤130 mm Hg (intensive treatment) versus ≤145 mm Hg (standard treatment) with antihypertensive therapies. Primary study outcomes were changes in mobility (gait speed) and accrual of white matter hyperintensity volume after 3 years. Changes in cognitive function (executive processing) and adverse events were also evaluated. RESULTS In 199 randomized patients, the mean age of the cohort was 80.5 years, and 54% were women; the average 24-hour systolic BP was 149 mm Hg. Goal BPs were achieved after a median treatment period of 3 to 4 months; at that time, the mean 24-hour systolic BP was 127.7 mm Hg in the intensive treatment group and 144.0 mm Hg in the standard treatment group for an average difference of 16.3 mm Hg. Changes in gait speed were not different between treatment groups (0.40±2.0 versus 0.42±2.7 s in the intensive treatment and standard treatment groups, respectively; P =0.91), whereas changes from baseline in white matter hyperintensity volumes were smaller (0.29%) in the intensive treatment group compared with the standard treatment group (0.48%; P =0.03). Cognitive outcomes also were not different between the treatment groups. Major adverse cardiovascular events were higher in the standard treatment group compared with the intensive treatment group (17 versus 4 patients; P =0.01). Falls, with or without injury, and syncope were comparable in the treatment groups. CONCLUSIONS Intensive lowering of ambulatory BP reduction in older patients with hypertension did not result in differences in mobility outcomes but was associated with a reduction in accrual of subcortical white matter disease. Over periods >3 years, a reduction in the accumulation of white matter disease may be a factor in conserving function. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01650402.",2019,Intensive lowering of ambulatory BP reduction in older patients with hypertension did not result in differences in mobility outcomes but was associated with a reduction in accrual of subcortical white matter disease.,"['199 randomized patients, the mean age of the cohort was 80.5 years, and 54% were women; the average 24-hour systolic BP was 149 mm\u2009Hg', 'older people with hypertension', 'Older People (INFINITY', 'patients ≥75 years of age with systolic hypertension and magnetic resonance imaging evidence of white matter hyperintensity lesions', 'older patients with hypertension']","['Intensive Versus Standard Ambulatory Blood Pressure Control', '24-hour mean systolic BP of ≤130 mm\u2009Hg (intensive treatment) versus ≤145 mm\u2009Hg (standard treatment) with antihypertensive therapies']","['mean 24-hour systolic BP', 'changes in mobility (gait speed) and accrual of white matter hyperintensity volume', 'white matter hyperintensity volumes', 'cognitive function (executive processing) and adverse events', 'Goal BPs', 'Falls, with or without injury, and syncope', 'Cognitive outcomes', 'mobility outcomes', '24-hour average systolic blood pressure (BP) on mobility, white matter disease progression, and cognitive function', 'Major adverse cardiovascular events', 'ambulatory BP reduction', 'Cerebrovascular Outcomes', 'Changes in gait speed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension (disorder)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0682708'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",199.0,0.106976,Intensive lowering of ambulatory BP reduction in older patients with hypertension did not result in differences in mobility outcomes but was associated with a reduction in accrual of subcortical white matter disease.,"[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center (W.B.W.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Dorothy B', 'Initials': 'DB', 'LastName': 'Wakefield', 'Affiliation': 'Department of Neurology (D.B.W., L.W.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Moscufo', 'Affiliation': ""Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.M., C.R.G.G.).""}, {'ForeName': 'Charles R G', 'Initials': 'CRG', 'LastName': 'Guttmann', 'Affiliation': ""Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.M., C.R.G.G.).""}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Kaplan', 'Affiliation': 'Department of Psychiatry (R.F.K.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Bohannon', 'Affiliation': 'College of Pharmacy and Health Sciences, Campbell University, Buies Creek, NC (R.W.B.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fellows', 'Affiliation': 'Department of Diagnostic Imaging (D.F.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Hall', 'Affiliation': 'Department of Epidemiology and Population Health and Saul B. Korey Department of Neurology, Albert Einstein College of Medicine, Bronx, NY (C.B.H.).'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wolfson', 'Affiliation': 'Department of Neurology (D.B.W., L.W.), University of Connecticut School of Medicine, Farmington.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041603'] 1142,30664050,"Transcranial Direct Current Stimulation on Opium Craving, Depression, and Anxiety: A Preliminary Study.","OBJECTIVES Transcranial direct current stimulation can be effective in reducing the craving for food, alcohol, and methamphetamine. Because its effects have not been tested on patients with opium use disorder, we investigated its efficacy when it is combined with a standard methadone maintenance therapy protocol. METHODS We carried out a pretest-posttest control group method to evaluate the effect of transcranial direct current stimulation at the dorsolateral prefrontal cortex (right anodal/left cathodal) on opium craving, depression, and anxiety symptoms. We considered opium craving as a primary outcome as well as depression and anxiety symptoms as secondary outcomes. Sixty participants with opium use disorder were randomly assigned into 3 groups (n = 20 for each group): (1) an active transcranial direct current stimulation with methadone maintenance treatment (active tDCS group), (2) sham transcranial direct current stimulation with methadone maintenance treatment (sham tDCS group), and (3) only methadone maintenance treatment (methadone maintenance treatment group). All participants completed the Desire for Drug Questionnaire, Obsessive-Compulsive Drug Use Scale, Beck Depression Inventory II, and Beck Anxiety Inventory a week before and a week after the treatment. The outcomes were assessed by independent assessors who were blind to the treatment conditions. RESULTS The active tDCS group had a significant reduction in opium craving, depression, and anxiety symptoms compared with the other 2 groups. CONCLUSIONS Our results provide a preliminary support for using the transcranial direct current stimulation along with methadone maintenance therapy in the treatment of patients with opium use disorder.",2019,"The active tDCS group had a significant reduction in opium craving, depression, and anxiety symptoms compared with the other 2 groups. ","['patients with opium use disorder', 'Sixty participants with opium use disorder']","['transcranial direct current stimulation at the dorsolateral prefrontal cortex (right anodal/left cathodal', 'active transcranial direct current stimulation with methadone maintenance treatment (active tDCS group), (2) sham transcranial direct current stimulation with methadone maintenance treatment (sham tDCS group), and (3) only methadone maintenance treatment (methadone maintenance treatment group', 'methadone maintenance therapy', 'Transcranial Direct Current Stimulation']","['Desire for Drug Questionnaire, Obsessive-Compulsive Drug Use Scale, Beck Depression Inventory II, and Beck Anxiety Inventory', 'depression and anxiety symptoms', 'opium craving, depression, and anxiety symptoms', 'Opium Craving, Depression, and Anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4704679', 'cui_str': 'Opium Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0029112', 'cui_str': 'Opium'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",60.0,0.101382,"The active tDCS group had a significant reduction in opium craving, depression, and anxiety symptoms compared with the other 2 groups. ","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Taremian', 'Affiliation': 'From the Substance Abuse and Dependence Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Nazari', 'Affiliation': 'School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Latif', 'Initials': 'L', 'LastName': 'Moradveisi', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Moloodi', 'Affiliation': 'From the Substance Abuse and Dependence Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",The journal of ECT,['10.1097/YCT.0000000000000568'] 1143,31010703,Leap Motion Controller-based training for upper extremity rehabilitation in children and adolescents with physical disabilities: A randomized controlled trial.,"STUDY DESIGN Randomized controlled trial. INTRODUCTION Juvenile idiopathic arthritis (JIA), cerebral palsy (CP), and brachial plexus birth injury (BPBI) are the most common disorders that cause upper extremity impairments in children and adolescents. Leap Motion Controller-based training (LMCBT) is a novel therapeutic method for upper extremity rehabilitation. PURPOSE OF THE STUDY The aim of the present study was to investigate the potential efficacy of an 8-week LMCBT program set as an upper extremity rehabilitation program by comparing conventional rehabilitation program in children and adolescents with physical disabilities such as JIA, CP, and BPBI. METHODS A randomized control trial which included children and adolescents of different disabilities (JIA, CP, BPBI) were grouped according to their diagnosis. All patients were randomized into 2 groups namely LMCBT (group I) and conventional treatment (group II) for the treatment (3 days/8 weeks). Duruoz Hand Index and Jebson Taylor Hand Function Test were used as primary outcomes. Secondary outcomes included the nine-hole peg test, Childhood Health Assessment Questionnaire, and assessments of grip and pinch strength using a dynamometer. RESULTS One hundred three patients were included in the study, and 92 of them completed the treatment. After treatment, significant differences were found in Childhood Health Assessment Questionnaire, Duruoz Hand Index, Jebson Taylor Hand Function Test, nine-hole peg test, and grip and pinch strength scores in almost all groups (effect size [ES] = 0.10 to -0.77 for group I and 0.09 to -0.70 for group II in CP; ES = 0.31 to 2.65 for the group I and 0.12 to 1.66 for group II in JIA; and ES = 0 to -0.44 for group I and 0.08 to -0.62 for group II in BPBI) (P < .05). Comparisons between LMCBT and conventional treatment groups showed similar results in all parameters in all disease groups (P > .05). CONCLUSIONS This study has quantitatively shown that LMCBT should be used as an effective alternative treatment option in children and adolescents with physical disabilities.",2020,"Comparisons between LMCBT and conventional treatment groups showed similar results in all parameters in all disease groups (P > .05). ","['children and adolescents with physical disabilities such as JIA, CP, and BPBI', 'children and adolescents of different disabilities (JIA, CP, BPBI', 'One hundred three patients were included in the study, and 92 of them completed the treatment', 'children and adolescents with physical disabilities', 'children and adolescents']","['conventional treatment', 'Leap Motion Controller-based training (LMCBT', 'BPBI', 'LMCBT program', 'Leap Motion Controller-based training', 'LMCBT', 'conventional rehabilitation program']","['nine-hole peg test, Childhood Health Assessment Questionnaire, and assessments of grip and pinch strength using a dynamometer', 'Childhood Health Assessment Questionnaire, Duruoz Hand Index, Jebson Taylor Hand Function Test, nine-hole peg test, and grip and pinch strength scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}, {'cui': 'C2732494', 'cui_str': 'Childhood health assessment questionnaire (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",103.0,0.0321016,"Comparisons between LMCBT and conventional treatment groups showed similar results in all parameters in all disease groups (P > .05). ","[{'ForeName': 'Ela', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Faculty of Health Sciences, Department of Neurological Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Bakirkoy, Istanbul, Turkey. Electronic address: fztela@hotmail.com.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Arman', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Bakirkoy, Istanbul, Turkey.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Tarakci', 'Affiliation': 'Faculty of Health Sciences, Department of Ergotherapy, Istanbul Medipol University, Bakirkoy, Istanbul, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Kasapcopur', 'Affiliation': 'Medical Faculty of Cerrahpasa, Department of Pediatric Rheumatology, Istanbul University-Cerrahpasa, Bakirkoy, Istanbul, Turkey.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.03.012'] 1144,30974479,Cognitive functional therapy in patients with non-specific chronic low back pain-a randomized controlled trial 3-year follow-up.,"OBJECTIVES This randomized controlled trial investigated the efficacy of cognitive functional therapy (CFT) compared with manual therapy and exercise (MT-EX) for people with non-specific chronic low back pain (NSCLBP) at 3-year follow-up. METHODS Hundred and twenty-one patients were randomized to CFT (n = 62) or MT-EX (n = 59). Three-year data were available for 30 (48.4%) participants in the CFT group, and 33 (55.9%) participants in the MT-EX group. The primary outcomes were disability (Oswestry disability Index [ODI]) and pain intensity (numerical rating scale) and secondary outcomes were anxiety/depression (Hopkins Symptoms Checklist) and pain-related fear (Fear-Avoidance Belief Questionnaire). A full intention to treat analysis was conducted using linear mixed models. RESULTS Significantly greater reductions in disability were observed for the CFT group, with ODI scores at 3 years 6.6 points lower in the CFT than the MT-EX group (95%CI:-10.1 to -3.1, p < 0.001, standardized effect size = 0.70). There was no significant difference in pain intensity between the groups at 3 years (0.6 points 95%CI:-1.4-0.3, p = 0.195). Significantly greater reductions were also observed for the CFT group for Hopkins Symptoms Checklist and Fear-Avoidance Belief Questionnaire (Work). CONCLUSIONS CFT is more effective at reducing disability, depression/anxiety and pain-related fear, but not pain, at 3-year follow-up than MT-EX. SIGNIFICANCE Cognitive functional therapy (CFT) was more effective than manual therapy and exercise (MT-EX) in reducing disability at 3-year follow-up, in people with non-specific chronic low back pain. The sustained reduction in disability without concomitant reductions in pain intensity in the CFT group suggests a de-coupling of the pain-disability relationship. CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX. The findings support the long-term benefits of a individualized behaviourally orientated intervention that targets pain beliefs, functional restoration and lifestyle factors.",2019,"CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX.","['patients with non-specific chronic low back pain', 'people with non-specific chronic low back pain', 'Hundred and twenty-one patients', 'people with non-specific chronic low back pain (NSCLBP) at 3-year follow-up']","['CFT', 'cognitive functional therapy (CFT', 'manual therapy and exercise (MT-EX', 'Cognitive functional therapy (CFT', 'MT-EX', 'Cognitive functional therapy']","['anxiety and depression, and pain-related fear regarding work', 'disability (Oswestry disability Index [ODI]) and pain intensity (numerical rating scale) and secondary outcomes were anxiety/depression (Hopkins Symptoms Checklist) and pain-related fear (Fear-Avoidance Belief Questionnaire', 'pain beliefs, functional restoration and lifestyle factors', 'Hopkins Symptoms Checklist and Fear-Avoidance Belief Questionnaire (Work', 'pain intensity', 'disability, depression/anxiety and pain-related fear', 'disability', 'ODI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",21.0,0.144855,"CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX.","[{'ForeName': 'Kjartan', 'Initials': 'K', 'LastName': 'Vibe Fersum', 'Affiliation': 'Physiotherapy Research Group, Department of Public Health and Primary Health Care, University of Bergen, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'School of Physiotherapy, Curtin University, Bentley, WA, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kvåle', 'Affiliation': 'Research group Movement and Function, Western Norway University of Applied Science, Bergen, Norway.'}, {'ForeName': 'Jan Sture', 'Initials': 'JS', 'LastName': 'Skouen', 'Affiliation': 'Physiotherapy Research Group, Department of Public Health and Primary Health Care, University of Bergen, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy, Curtin University, Bentley, WA, Australia.'}]","European journal of pain (London, England)",['10.1002/ejp.1399'] 1145,30844881,"Transcranial Direct Current Stimulation Reduces Craving in Substance Use Disorders: A Double-blind, Placebo-Controlled Study.","OBJECTIVES The use of transcranial direct current stimulation (tDCS) in addiction disorders is still on its rise in comparison with pharmacological and psychotherapeutic strategies that still show low level of evidence. In this study, we aimed to evaluate the efficacy of the anodic tDCS for the short-term treatment of substance craving and other psychiatric symptoms. METHODS In this randomized, double-blind, sham-controlled trial, inclusion criteria included the diagnosis of substance use disorder and/or gambling disorder. The protocol includes 5 consecutive days of active or sham tDCS session. Cathode was placed over the left dorsolateral prefrontal cortex. Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Young Mania Rating Scale, Barratt Impulsiveness Scale, South Oaks Gambling Screen, and visual analog scale (VAS) 1 to 10 for craving were administered at the baseline (T0) and after 5 days of treatment (T1). RESULTS Thirty-four treatment-seeking subjects were randomized to sham (n = 16) and active stimulation (n = 18) groups. A statistically significant reduction of values at T1 was found in all subjects considering VAS (P < 0.001), Hamilton Depression Rating Scale (P < 0.001), Hamilton Anxiety Rating Scale (P < 0.001), and Barratt Impulsiveness Scale 11 (P = 0.032). A significant reduction for VAS craving in favor of the active stimulation (P = 0.011) was found. CONCLUSIONS Our findings reveal a statistically significant rapid reduction of craving in the active tDCS group on the right dorsolateral prefrontal cortex with respect to sham group, confirming the scientific literature trend. Large samples, with maintenance tDCS therapy and long-term follow-up, are required to establish the potential of this noninvasive and easily delivered brain stimulation strategy.",2019,"A significant reduction for VAS craving in favor of the active stimulation (P = 0.011) was found. ","['Substance Use Disorders', 'Thirty-four treatment-seeking subjects']","['transcranial direct current stimulation (tDCS', 'Placebo', 'active stimulation', 'anodic tDCS', 'Transcranial Direct Current Stimulation']","['Hamilton Anxiety Rating Scale', 'Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Young Mania Rating Scale, Barratt Impulsiveness Scale, South Oaks Gambling Screen, and visual analog scale (VAS) 1 to 10 for craving', 'Barratt Impulsiveness Scale', 'Hamilton Depression Rating Scale', 'VAS craving']","[{'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",34.0,0.110315,"A significant reduction for VAS craving in favor of the active stimulation (P = 0.011) was found. ","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinotti', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lupi', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Montemitro', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Miuli', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Di Natale', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Spano', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Mancini', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lorusso', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Stigliano', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tambelli', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Carlo', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Di Caprio', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Fraticelli', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Chillemi', 'Affiliation': 'Struttura Residenziale Psichiatrica ""Villa Maria Pia,"" Rome, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Pettorruso', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Gianna', 'Initials': 'G', 'LastName': 'Sepede', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'di Giannantonio', 'Affiliation': 'From the Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}]",The journal of ECT,['10.1097/YCT.0000000000000580'] 1146,30988853,Post-Activation Potentiation: Is there an Optimal Training Volume and Intensity to Induce Improvements in Vertical Jump Ability in Highly-Trained Subjects?,"The aim of this study was to compare the acute effects of performing half squats (HSs) with different loading intensities (1, 3, and 5 repetitions maximum [RM], and 60% 1RM) and a different number of sets (1, 2, and 3) on the countermovement jump (CMJ) performance of 18 highly-trained male subjects. Participants were submitted to four experimental conditions (1RM, 3RM, 5RM, and 60% 1RM) in randomized order. The CMJ was assessed before and after each set. Differences in CMJ performance between the distinct experimental conditions and individual responses in CMJ performance induced by the different protocols were analyzed via the magnitude-based inference method. Overall, significant improvements were detected in individual CMJ heights after each activation protocol. It can be concluded that the use of 1 to 3 sets of HSs performed at moderate-to-high loads may be an effective strategy to improve jump performance in highly-trained subjects. Nevertheless, despite the high efficiency of the protocols tested here, coaches and researchers are strongly encouraged to perform individualized assessments within the proposed range of loads and sets, to find optimal and tailored post-activation potentiation protocols.",2019,Differences in CMJ performance between the distinct experimental conditions and individual responses in CMJ performance induced by the different protocols were analyzed via the magnitude-based inference method.,['18 highly-trained male subjects'],"['Post-Activation Potentiation', 'performing half squats (HSs']","['jump performance', 'individual CMJ heights', 'CMJ performance', 'countermovement jump (CMJ) performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.021219,Differences in CMJ performance between the distinct experimental conditions and individual responses in CMJ performance induced by the different protocols were analyzed via the magnitude-based inference method.,"[{'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Kobal', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Lucas A', 'Initials': 'LA', 'LastName': 'Pereira', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Anderson C', 'Initials': 'AC', 'LastName': 'Paulo', 'Affiliation': 'Academic Department of Physical Education of the Federal Technological University of Paraná, São Paulo, Brazil.'}, {'ForeName': 'Henrique A', 'Initials': 'HA', 'LastName': 'Ramos', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Everton C', 'Initials': 'EC', 'LastName': 'Carmo', 'Affiliation': 'Physical Education, Senac University Center, São Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valmor', 'Initials': 'V', 'LastName': 'Tricoli', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': 'Faculty of Science and Technology, London Sports Institute, Middlesex University, London, UK.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}]",Journal of human kinetics,['10.2478/hukin-2018-0071'] 1147,31006262,No effect of femoral canal jet-lavage on the stability of cementless stems in primary hip arthroplasty: a randomised RSA study with 6 years follow-up.,"INTRODUCTION In contrast to cemented hip prostheses, the effect of washing the bone bed with jet-lavage prior to insertion of cementless stem components in primary hip arthroplasty (THA) is unclear. Jet-lavage potentially decreases the risk of fat embolisation during rasping and stem insertion and might help in avoiding bacterial contamination. An earlier animal study has shown less debris and better-organised trabecular structure of new bone when jet-lavage was used. We hypothesised that the primary stability of cementless femoral stems implanted after jet-lavage of the femoral canal prior to stem insertion would improve with earlier stabilisation, as measured with Radiostereometry (RSA), compared with insertion without prior jet-lavage. METHODS 40 patients with primary osteoarthritis operated on with a cementless titanium grit blasted stem are included in the study. The patients were randomised to either jet-lavage or control without any lavage of the femoral canal prior to insertion of the prosthesis. The stem migration pattern was measured with RSA at 0, 3, 12, 24 and 72 months. RESULTS At 6 years, 19 patients remained for analysis in the jet-lavage and 18 in the control group. We found no difference in extent or pattern of migration as measured with RSA. Both groups seemed to have stabilised within 3 months after a slight subsidence and retroversion. No stem was revised or considered loose as measured with RSA. CONCLUSIONS Washing the bone bed with jet-lavage prior to insertion of cementless stems does not affect the stability of cementless femoral components. No adverse effects were observed.",2020,Washing the bone bed with jet-lavage prior to insertion of cementless stems does not affect the stability of cementless femoral components.,"['primary hip arthroplasty (THA', '40 patients with primary osteoarthritis operated on with a cementless titanium grit blasted stem are included in the study', 'primary hip arthroplasty']","['femoral canal jet-lavage', 'jet-lavage or control without any lavage of the femoral canal prior to insertion of the prosthesis']","['adverse effects', 'stability of cementless femoral components', 'risk of fat embolisation']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384584', 'cui_str': 'Generalized osteoarthritis (disorder)'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C3813727', 'cui_str': 'Grits (substance)'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0225269', 'cui_str': 'Femoral canal structure'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]",40.0,0.0539229,Washing the bone bed with jet-lavage prior to insertion of cementless stems does not affect the stability of cementless femoral components.,"[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Zampelis', 'Affiliation': 'Department of Orthopaedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Department of Orthopaedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Uldis', 'Initials': 'U', 'LastName': 'Kesteris', 'Affiliation': 'Department of Orthopaedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019843123'] 1148,30986148,Does Animation Facilitate Understanding of Graphic Symbols Representing Verbs in Children With Autism Spectrum Disorder?,"Purpose The effects of animation on identification of graphic symbols for verbs were studied using the Autism Language Program Graphic Symbols Set in children diagnosed with mild-to-severe autism spectrum disorder between the ages of 3 and 7 years. Method The participants were randomly assigned to an animated symbol condition or a static symbol condition. Static symbols were spliced from the animated symbols to ensure that the symbols differed only in terms of the absence or presence of movement. The participants were asked to identify a target symbol among foils given the spoken label. Results There were no significant differences between the groups with respect to chronological age, autism severity, and receptive target verb knowledge. An independent t test revealed that animated symbols were more readily identified than static symbols. Conclusions Animation enhances the identification of verbs in children with autism spectrum disorder. Clinicians are encouraged to take advantage of animation when introducing graphic symbols representing verbs. Limitations and implications for future research are discussed.",2019,"There were no significant differences between the groups with respect to chronological age, autism severity, and receptive target verb knowledge.","['children diagnosed with mild-to-severe autism spectrum disorder between the ages of 3 and 7 years', 'children with autism spectrum disorder', 'Children With Autism']",['animated symbol condition or a static symbol condition'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]",[],,0.0196636,"There were no significant differences between the groups with respect to chronological age, autism severity, and receptive target verb knowledge.","[{'ForeName': 'Ralf W', 'Initials': 'RW', 'LastName': 'Schlosser', 'Affiliation': 'Departments of Communication Sciences and Disorders and Applied Psychology, Northeastern University, Boston, MA.'}, {'ForeName': 'Kris L', 'Initials': 'KL', 'LastName': 'Brock', 'Affiliation': 'Department of Communication Sciences and Disorders, Idaho State University, Pocatello.'}, {'ForeName': 'Rajinder', 'Initials': 'R', 'LastName': 'Koul', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Texas at Austin.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Shane', 'Affiliation': ""Department of Otolaryngology and Communication Enhancement, Boston Children's Hospital, MA.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Flynn', 'Affiliation': 'Department of Linguistics, Massachusetts Institute of Technology, Cambridge.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2018_JSLHR-L-18-0243'] 1149,30973454,Continuation Electroconvulsive Therapy for Patients With Clozapine-Resistant Schizophrenia: A Pilot Study.,"OBJECTIVES The risk of relapse after a successful acute course of treatment is a clinical challenge in electroconvulsive therapy (ECT) practice, particularly in patients with a history of marked resistance to previous treatments. Research suggests that a gradual decrease of ECT or its long-term continuation might be the best strategy. Notwithstanding, current studies do not address the role of continuation ECT in the truly refractory cases, that is, the clozapine-resistant patients. Our group published a randomized controlled trial of ECT augmentation of clozapine in clozapine-resistant patients with schizophrenia, where the augmentation was vastly superior in efficacy for the acute treatment. The aim of the current study is to evaluate the efficacy of continuation ECT for patients who showed response to the combination of acute ECT and clozapine for treatment-resistant schizophrenia. METHODS Continuation ECT was offered to all patients who completed the acute study and who met response criterion. We followed a tapered schedule of 4 weekly ECT sessions, followed by 4 ECT sessions every 2 weeks and 2 monthly ECT sessions for a total of 10 sessions. RESULTS Patients sustained the gains achieved with the acute course of ECT, and no individual patient presented with clinically relevant worsening of symptoms. Moreover, the long-term use of ECT was not associated with added adverse effects. CONCLUSIONS This is an open pilot study with a small sample size, and results should be interpreted accordingly, but this report offers a relevant starting point for much needed future studies.",2019,"Moreover, the long-term use of ECT was not associated with added adverse effects. ","['Patients With Clozapine-Resistant Schizophrenia', 'patients who completed the acute study and who met response criterion', 'resistant patients with schizophrenia', 'patients who showed response to the combination of acute ECT and clozapine for treatment-resistant schizophrenia', 'patients with a history of marked resistance to previous treatments']","['continuation ECT', 'clozapine', 'electroconvulsive therapy (ECT) practice', 'ECT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}]",[],,0.0528118,"Moreover, the long-term use of ECT was not associated with added adverse effects. ","[{'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Braga', 'Affiliation': 'From the Division of Psychiatry Research, The Zucker Hillside Hospital, Northwell Health, Glen Oaks; and The Feinstein Institute for Medical Research, Manhasset, NY.'}, {'ForeName': 'Majnu', 'Initials': 'M', 'LastName': 'John', 'Affiliation': ''}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Schooler', 'Affiliation': ''}, {'ForeName': 'Samuel H', 'Initials': 'SH', 'LastName': 'Bailine', 'Affiliation': ''}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Malur', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Mendelowitz', 'Affiliation': ''}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Petrides', 'Affiliation': ''}]",The journal of ECT,['10.1097/YCT.0000000000000588'] 1150,30972746,Continued treatment with secukinumab is associated with high retention or regain of response.,"BACKGROUND Conventional analyses present aggregate data, masking late responders and efficacy reductions. Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, shows sustained efficacy in moderate-to-severe psoriasis. OBJECTIVES To determine stability of response to secukinumab, changes in efficacy were assessed in individual patients. METHODS This is a post hoc analysis of two phase III randomized controlled trials, FIXTURE (trial registration: NCT01358578) and CLEAR (trial registration: NCT02074982). Patients received secukinumab 300 mg (FIXTURE and CLEAR), etanercept 50 mg (FIXTURE) or ustekinumab 45 or 90 mg (CLEAR) over 52 weeks. Mutually exclusive response categories were defined: ≥ 90% improvement in the Psoriasis Area and Severity Index (PASI 90) ('excellent'), ≥ 75% improvement in PASI (PASI 75) and < PASI 90 ('good') and < PASI 75 ('insufficient'). Reductions in efficacy were defined as shifts from higher to lower response categories between two consecutive visits maintained for a third consecutive visit. Loss of efficacy was defined as a reduction of efficacy resulting in 'insufficient' response. All comparisons are descriptive. RESULTS At 52 weeks, in CLEAR, 90·2% (303/336) of patients on secukinumab achieved stable efficacy without loss and 77·7% (261/336) showed stable efficacy without any reduction of response [74·3% (252/339) and 59·9% (203/339) of patients for ustekinumab]. In FIXTURE, 83·5% (273/327) and 66·4% (217/327) of patients on secukinumab had stable efficacy without loss or reduction of response [58·3% (190/326) and 42·6% (139/326) for etanercept]. Response was regained by continuing secukinumab treatment in 50% (8/16) of patients in CLEAR and 26% (9/34) in FIXTURE. Similar patterns were observed for other response definitions. CONCLUSIONS Efficacy with secukinumab was stable over 52 weeks of treatment in most patients. Continued treatment with secukinumab resulted in regain of efficacy in some patients. Persistent loss of response was uncommon. What's already known about this topic? Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, shows significant and sustained efficacy in the treatment of moderate-to-severe psoriasis. Secondary loss of response may be experienced by a minority of patients treated with secukinumab, as with other biologics, but the extent of this and the potential for regain of efficacy with continued treatment is not well understood. What does this study add? To determine stability of response to secukinumab and inform clinical practice, changes in efficacy were assessed at individual patient level using response categories. Efficacy with secukinumab was stable over 52 weeks of treatment in most patients, and continued treatment with secukinumab resulted in efficacy regain after loss in some patients. Persistent loss of response was uncommon. Patient factors such as body weight may affect the likelihood of loss of efficacy.",2020,"Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, shows sustained efficacy in moderate-to-severe psoriasis. ",['individual patients'],"['secukinumab 300\xa0mg (FIXTURE and CLEAR), etanercept 50\xa0mg (FIXTURE) or ustekinumab 45 or 90\xa0mg (CLEAR', 'FIXTURE', 'secukinumab']","['regain of efficacy', ""Psoriasis Area and Severity Index (PASI 90) ('excellent'), ≥ 75% improvement in PASI""]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}]",,0.0900575,"Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, shows sustained efficacy in moderate-to-severe psoriasis. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institute of Health Services Research in Dermatology and Nursing, University Medical Center of Hamburg Eppendorf, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaci', 'Affiliation': 'Comprehensive Centre of Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eyerich', 'Affiliation': 'Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Radtke', 'Affiliation': 'Institute of Health Services Research in Dermatology and Nursing, University Medical Center of Hamburg Eppendorf, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lauffer', 'Affiliation': 'Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pariser', 'Affiliation': 'Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sieder', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Melzer', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Dermatologikum Berlin and SCIderm Research Institute, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.17991'] 1151,30797389,Do self-administered positive psychology exercises work in persons in recovery from problematic substance use? An online randomized survey.,"Quality of life and psychological well-being are increasingly being recognized as important factors in and outcomes of substance use treatment. Very little empirical evidence exists, however, to indicate if and how positive psychological outcomes could be targeted within treatment. Using a randomized survey administered online, we examined 5 brief, self-administered happiness exercises, and tested if completion of these exercises resulted in increases in in-the-moment happiness compared to 2 control exercises. Participants were n = 531 adults describing themselves as seeking or being in recovery from problematic substance use, who were recruited online from recovery-focused websites. Participants rated in-the-moment happiness immediately pre- and post-completing randomized text-entry-based exercises. Results indicate that in-the-moment happiness increased in participants randomized to happiness exercises while it decreased in controls (F(1, 444) = 9.94, p = 0.0017). Greatest pre-post increases in happiness were observed for the ""Reliving Happy Moments"" exercise (g av  = 0.15), followed by ""Savoring"" (g av  = 0.09) and ""Rose, Thorn, Bud"" (g av  = 0.07). Our modified ""3 Good Things"" exercises performed relatively poorly (g av  = 0.02). The control exercise ""3 Hard Things"" resulted in the greatest negative pre-post difference (g av  = -0.10). Exercises took on average 4 ± 4 min to complete and most participants (93%) felt they could complete them as part of their daily routine. Effectiveness, ease of use, and positive views of the tested brief, self-administered positive psychology exercises render them promising tools to bolster happiness during treatment, which may have utility in supporting long-term recovery. Observed decreases in happiness in response to the ""3 Hard Things"" exercise underscore the importance of offsetting the challenges of recovery with positive experiences.",2019,"Greatest pre-post increases in happiness were observed for the ""Reliving Happy Moments"" exercise (g av  = 0.15), followed by ""Savoring"" (g av  = 0.09) and ""Rose, Thorn, Bud"" (","['Participants were n\u202f=\u202f531 adults describing themselves as seeking or being in recovery from problematic substance use, who were recruited online from recovery-focused websites']",[],['happiness exercises'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]",[],"[{'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",531.0,0.103763,"Greatest pre-post increases in happiness were observed for the ""Reliving Happy Moments"" exercise (g av  = 0.15), followed by ""Savoring"" (g av  = 0.09) and ""Rose, Thorn, Bud"" (","[{'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Recovery Research Institute, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. Electronic address: bhoeppner@mgh.harvard.edu.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Schick', 'Affiliation': 'Recovery Research Institute, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Carlon', 'Affiliation': 'Recovery Research Institute, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Recovery Research Institute, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.006'] 1152,30823563,Consumption of Animal-Source Protein is Associated with Improved Height-for-Age z Scores in Rural Malawian Children Aged 12⁻36 Months.,"Linear growth faltering, caused by insufficient diet, recurrent infections and environmental enteric dysfunction (EED), continues to plague young children in low- and middle-income countries (LMICs). Diets in LMICs are primarily plant based, and thus have poor-quality protein and low levels of essential micronutrients. The aim of this study was to assess the association of the type and protein quality of food consumed with stunting, EED and acute malnutrition in children aged 6⁻36 months in Limera and Masenjere, two rural Southern Malawian communities. This is a secondary analysis of two randomized controlled trials that tested the effects of common bean and cowpea flour on stunting in children aged 6⁻36 months. We used data from two interactive 24-h dietary recalls conducted 12 weeks after enrolment into each trial. Food intakes were compared between the regions using Chi-square and Student's t -test. There were 355 children that participated in the dietary recalls. The diets of children were of poor quality, but the children from Limera consumed more fish (54% vs. 35%, p = 0.009) and more bioavailable protein (26.0 ± 10.3 g/day vs. 23.1 ± 8.1 g/day, p = 0.018, respectively) than children in Masenjere. Food type and protein quality were not associated with any of the outcomes except an association between animal protein consumption and improvement in height-for-age z scores in children aged 12⁻36 months ( p = 0.047). These findings support the notion that animal-source food (ASF) consumption in this vulnerable population promotes linear growth.",2019,Food type and protein quality were not associated with any of the outcomes except an association between animal protein consumption and improvement in height-for-age z scores in children aged 12⁻36 months ( p = 0.047).,"['children aged 6⁻36 months in Limera and Masenjere, two rural Southern Malawian communities', 'Rural Malawian Children Aged 12⁻36 Months', '355 children that participated in the dietary recalls', 'plague young children in low- and middle-income countries (LMICs', 'children aged 6⁻36 months']",['common bean and cowpea flour'],"['Food type and protein quality', 'Food intakes', 'bioavailable protein']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032064', 'cui_str': 'Yersinia pestis Infection'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0996862', 'cui_str': 'Vigna'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]",355.0,0.0643817,Food type and protein quality were not associated with any of the outcomes except an association between animal protein consumption and improvement in height-for-age z scores in children aged 12⁻36 months ( p = 0.047).,"[{'ForeName': 'Yankho', 'Initials': 'Y', 'LastName': 'Kaimila', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. ykaimila1@gmail.com.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Divala', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. odivala@yahoo.com.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Agapova', 'Affiliation': 'Washington University School of Medicine, Department of Pediatrics, Campus Box 8116, St. Louis, MO 63110, USA. shtepaz@gmail.com.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Stephenson', 'Affiliation': 'Washington University School of Medicine, Department of Pediatrics, Campus Box 8116, St. Louis, MO 63110, USA. kbstephe@gmail.com.'}, {'ForeName': 'Chrissie', 'Initials': 'C', 'LastName': 'Thakwalakwa', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. cthakwalakwa@yahoo.com.'}, {'ForeName': 'Indi', 'Initials': 'I', 'LastName': 'Trehan', 'Affiliation': 'Washington University School of Medicine, Department of Pediatrics, Campus Box 8116, St. Louis, MO 63110, USA. itrehan@wustl.edu.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. manarymj@wustl.edu.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Private Bag 360, Blantyre 3, Malawi. kmaleta@medcol.mw.'}]",Nutrients,['10.3390/nu11020480'] 1153,30959546,Effect of Partial Fibula Osteotomy Combined with Arthroscopic Debridement Surgery in the Treatment of Medial Compartment Knee Osteoarthritis.,"This study aimed to investigate the effect of partial fibula osteotomy combined with arthroscopic debridement surgery on the treatment of medial compartment knee osteoarthritis. From January 2013 to June 2016, 17 patients who suffered from medial compartment knee osteoarthritis were assigned to two groups: groups A ( n  = 5) and B ( n  = 12). Group A patients were treated with arthroscopic debridement surgery only, while group B patients received additional fibula osteotomy in addition to arthroscopic debridement operation. Visual analogue score (VAS) and hospital for special surgery (HSS) knee score were evaluated and compared between the two groups. Group B had significant reduction in the VAS after the procedure (3.1 ± 0.8) compared with that before the procedure (6.9 ± 1.0) or group A after surgery (5.4), respectively, p  < 0.05. In contrast, the HSS knee score increased significantly in group B after the procedure (83.6 ± 2.5) compared with that before the procedure (63.0 ± 3.8) or group A after the surgery (68.2 ± 2.8), respectively, p  < 0.05. Partial fibula osteotomy combined with arthroscopic debridement surgery is superior to arthroscopic debridement surgery only in the treatment of medial compartment knee osteoarthritis.",2020,"Group B had significant reduction in the VAS after the procedure (3.1 ± 0.8) compared with that before the procedure (6.9 ± 1.0) or group A after surgery (5.4), respectively, p  < 0.05.","['Medial Compartment Knee Osteoarthritis', 'From January 2013 to June 2016, 17 patients who suffered from medial compartment knee osteoarthritis', 'medial compartment knee osteoarthritis']","['Partial fibula osteotomy combined with arthroscopic debridement surgery', 'partial fibula osteotomy combined with arthroscopic debridement surgery', 'additional fibula osteotomy in addition to arthroscopic debridement operation', 'Partial Fibula Osteotomy Combined with Arthroscopic Debridement Surgery', 'arthroscopic debridement surgery']","['Visual analogue score (VAS) and hospital for special surgery (HSS) knee score', 'HSS knee score', 'VAS']","[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0016068', 'cui_str': 'Fibula'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",,0.0220754,"Group B had significant reduction in the VAS after the procedure (3.1 ± 0.8) compared with that before the procedure (6.9 ± 1.0) or group A after surgery (5.4), respectively, p  < 0.05.","[{'ForeName': 'Ying-Ming', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, P.R. China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, P.R. China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Kong', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, P.R. China.'}, {'ForeName': 'De-Wan', 'Initials': 'DW', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, P.R. China.'}, {'ForeName': 'Qi-Chun', 'Initials': 'QC', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, P.R. China.'}]",The journal of knee surgery,['10.1055/s-0039-1685158'] 1154,28944500,"Social, cognitive, and physiological aspects of humour perception from 4 to 8 months: Two longitudinal studies.","Infants laugh by 4 months, but whether they understand humour based on social or cognitive factors is unclear. We conducted two longitudinal studies of 4-, 6-, and 8-month-olds (N = 60), and 5-, 6-, and 7-month-olds (N = 53) to pinpoint the onset of independent humour perception and determine when social and cognitive factors are most salient. Infants were shown six events in randomized repeated-measures designs: two ordinary events and two absurd iterations of those events, with parents' affect manipulated (laugh or neutral) during the latter. Four-month-olds did not smile/laugh more at absurd events, but exhibited a significant heart rate deceleration. Five-month-olds independently appraised absurd events as humorous, smiling/laughing despite their parents' neutrality. Parent laughter did not influence infants of any age to smile more, but captured 4-month-olds' attention. Results suggest that 4-month-olds laugh in response to social cues, while 5-month-olds' can laugh in response to cognitive features. Statement of contribution What is already known on this subject? By 6 months, infants can independently appraise absurd events as humorous, but it is not known whether younger infants can. What does this study add? This study replicated the finding on younger infants, showing that 5-month-olds are similarly capable of independent humour appraisal. These studies also found that although 4-month-olds do not respond to absurd events with positive affect, they do exhibit a heart rate decrease that is unrelated to looking. These studies help delineate when social and cognitive factors contribute to infant humour perception.",2018,"Parent laughter did not influence infants of any age to smile more, but captured 4-month-olds' attention.",[],[],['heart rate deceleration'],[],[],"[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}]",,0.0175048,"Parent laughter did not influence infants of any age to smile more, but captured 4-month-olds' attention.","[{'ForeName': 'Gina C', 'Initials': 'GC', 'LastName': 'Mireault', 'Affiliation': 'Department of Behavioral Sciences, Johnson State College, Johnson, Vermont, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Crockenberg', 'Affiliation': 'University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Heilman', 'Affiliation': 'University of North Carolina Medical School, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Sparrow', 'Affiliation': 'University of New Hampshire, Manchester, New Hampshire, USA.'}, {'ForeName': 'Kassandra', 'Initials': 'K', 'LastName': 'Cousineau', 'Affiliation': 'Department of Behavioral Sciences, Johnson State College, Johnson, Vermont, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Rainville', 'Affiliation': 'Department of Behavioral Sciences, Johnson State College, Johnson, Vermont, USA.'}]",The British journal of developmental psychology,['10.1111/bjdp.12216'] 1155,30957654,"""Sex Offender"" Versus ""Person"": The Influence of Labels on Willingness to Volunteer With People Who Have Sexually Abused.","The present study examined the effect of offense-based labels on community members' willingness to volunteer with people convicted for varying offenses and any priming effect of labeling language. Participants ( N = 310) were randomly assigned to a label condition or a neutral condition and completed an anonymous online survey about their willingness to volunteer with different groups. The labeling condition utilized labels (e.g., ""sex offenders,"" ""murderers""), whereas the control condition utilized neutral descriptors (e.g., ""people who have committed crimes of a sexual nature""). Overall, findings supported the hypothesis that offense-based labels were associated with less willingness to volunteer, with findings most pronounced for the ""sex offender"" and ""child sex offender"" labels. Participants in the labeling condition showed greater voluntary use of labels compared with neutral language and were more likely to use labels compared with participants in the neutral condition. Implications for influencing public opinion are discussed.",2020,Participants in the labeling condition showed greater voluntary use of labels compared with neutral language and were more likely to use labels compared with participants in the neutral condition.,"['Participants ( N = 310', 'Sex Offender"" Versus ""Person']",['label condition or a neutral condition and completed an anonymous online survey about their willingness to volunteer with different groups'],[],"[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],310.0,0.0359579,Participants in the labeling condition showed greater voluntary use of labels compared with neutral language and were more likely to use labels compared with participants in the neutral condition.,"[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Lowe', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Gwenda', 'Initials': 'G', 'LastName': 'Willis', 'Affiliation': 'The University of Auckland, New Zealand.'}]",Sexual abuse : a journal of research and treatment,['10.1177/1079063219841904'] 1156,30918861,Diets along with interval training regimes improves inflammatory & anti-inflammatory condition in obesity with type 2 diabetes subjects.,"Background Different physical activities and diets change the regulation of inflammations in both type 2 diabetes (T2D) patients and obese individuals, but the effect of both (Physical activity and diet) on pro/anti-inflammations has remained unknown. We investigated pro/anti-inflammations control, cardiovascular function, and total physiological parameters before and after 24 weeks of low volume high intensity interval training (HIIT) on a cycle ergometer along with four dietary regimes in obesity with T2D patients. Methods 33 non-active obesity T2D patients (BMI ≥ 30) midges (47 yrs. ± 5) were volunteered to participate and randomly divided into three experimental( n  = 11) [(1) LCD = low Carbohydrate Diet, (2) LFD = Low Fat Diet and (3) HFD = High Fat Diet)] and one control ( n  = 9) [ND = normal diet] groups. The whole groups performed underwent 8-week dietary regimes and then performed 3 days/weeks (3 set 10 × 60 s) HIIT on a cycle ergometer for 12 weeks, which followed by a 4-week diet period again. Also, prior to and after 8 weeks diet-12 weeks High Intensity Interval Training (HIIT) and 4 weeks diet 2-h oral glucose tolerance test (OGTT), resting blood pressure, incremental maximal oxygen uptake (VO2peak) cycle ergometer test and blood sample was collected from the subjects in order to measure pro/anti-inflammatory cytokines (IL-6, TNF-α, leptin, resistin, adiponectin, and FGF21). Results After 24 weeks of intervention, the results indicated that the highest improvement in the percentage of changes in glucose happened in LCD (-34.76), insulin in ND (+16.43), cholesterol in LCD (-33.35), LDL in LFD (-9.14), HDL in LCD (+41.81), TG in LCD (-40.71), weight in LCD (-12.49) and HOMA-IR in HFD (-6.82). The results also indicated that after 24 weeks of HIIT and diet interventions, highest benefit percentage change IL-6, resistin and leptin occurred in LCD (-32.10, -28.29 and - 53.92, respectively), TNF-α, FGF21 and adiponectin in LFD (-48.06, +55.30 and + 42.32, respectively). However, these changes were observed in other groups. Conclusions These results demonstrated that HIIT along with low carbohydrate regimes improves overall cardiovascular parameters and reduce pro-inflammatory markers and increase anti-inflammatory markers in type 2 diabetic patients. Additionally, as with HIIT along with low carbohydrate, HIIT coupled with low fat would improve inflammation markers, though these effects were less significant. These findings suggest that HIIT along with low carbohydrate is a beneficial exercise and dietary strategy in T2D patients.",2018,"The results also indicated that after 24 weeks of HIIT and diet interventions, highest benefit percentage change IL-6, resistin and leptin occurred in LCD (-32.10, -28.29 and - 53.92, respectively), TNF-α, FGF21 and adiponectin in LFD (-48.06, +55.30 and + 42.32, respectively).","['T2D patients (BMI\u2009≥\u200930) midges (47\xa0yrs', 'type 2 diabetes (T2D) patients and obese individuals', 'Methods\n\n\n33 non-active obesity', '±\u20095) were volunteered to participate and randomly divided into three experimental( n \u2009=\u200911', 'T2D patients', 'type 2 diabetic patients', 'obesity with T2D patients', 'obesity with type 2 diabetes subjects']","['High Intensity Interval Training (HIIT) and 4\xa0weeks', 'low volume high intensity interval training (HIIT']","['overall cardiovascular parameters and reduce pro-inflammatory markers and increase anti-inflammatory markers', 'percentage of changes in glucose happened in LCD (-34.76), insulin in ND (+16.43), cholesterol in LCD (-33.35), LDL in LFD (-9.14), HDL in LCD (+41.81), TG in LCD (-40.71), weight in LCD (-12.49) and HOMA-IR', 'diet 2-h oral glucose tolerance test (OGTT), resting blood pressure, incremental maximal oxygen uptake (VO2peak) cycle ergometer test and blood sample', 'TNF-α, FGF21 and adiponectin in LFD', 'pro/anti-inflammatory cytokines (IL-6, TNF-α, leptin, resistin, adiponectin, and FGF21', 'inflammation markers', 'IL-6, resistin and leptin occurred in LCD', 'inflammatory & anti-inflammatory condition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026074', 'cui_str': 'Midge (organism)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0065190', 'cui_str': 'low density lipoprotein inhibitor'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0129392,"The results also indicated that after 24 weeks of HIIT and diet interventions, highest benefit percentage change IL-6, resistin and leptin occurred in LCD (-32.10, -28.29 and - 53.92, respectively), TNF-α, FGF21 and adiponectin in LFD (-48.06, +55.30 and + 42.32, respectively).","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Asle Mohammadi Zadeh', 'Affiliation': '1Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Hezar Jerib Street, P.O. Box 81746-7344, Isfahan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Kargarfard', 'Affiliation': '1Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Hezar Jerib Street, P.O. Box 81746-7344, Isfahan, Iran.'}, {'ForeName': 'Syed Mohamad', 'Initials': 'SM', 'LastName': 'Marandi', 'Affiliation': '1Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Hezar Jerib Street, P.O. Box 81746-7344, Isfahan, Iran.'}, {'ForeName': 'Abdolhamid', 'Initials': 'A', 'LastName': 'Habibi', 'Affiliation': '2Department of Physical Education and Sport Sciences, Shahid Chamran University, Ahwaz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-018-0368-0'] 1157,30908136,Effectiveness of mindfulness-based coloring for university students' test anxiety.,"Objective : This study compared the effectiveness of mindfulness coloring (mandala), free drawing/coloring, and a noncoloring control activity for university students' test anxiety, and assessed the relationship of dispositional mindfulness and response to intervention on mindfulness and test anxiety states. Participants : University students ( n  = 167; 81.4% female; M age = 21.29 years, SD  = 4.46) were randomly assigned to a mandala ( n  = 57), free draw/coloring ( n  = 58), or noncoloring condition ( n  = 52). Methods : Participants completed standardized measures assessing test anxiety and state mindfulness pre-postactivity before completing a test, and two dispositional mindfulness measures. Results : Participants in both coloring conditions reported significant decreases in test anxiety and significant increases in state mindfulness pre-postintervention, and participants in the control condition reported significant increases in test anxiety. Reports of preintervention state mindfulness and test anxiety fully mediated relations between dispositional mindfulness and postintervention state mindfulness and test anxiety. Conclusions : Implications for research and practice on mindfulness coloring and test anxiety are discussed.",2020,"RESULTS Participants in both coloring conditions reported significant decreases in test anxiety and significant increases in state mindfulness pre-postintervention, and participants in the control condition reported significant increases in test anxiety.","['University students (n\u2009=\u2009167; 81.4% female; M age = 21.29\u2009years, SD\u2009=\u20094.46', ""university students' test anxiety""]","['mindfulness-based coloring', 'mindfulness coloring (mandala), free drawing/coloring']","['state mindfulness pre-postintervention', 'test anxiety']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0181674,"RESULTS Participants in both coloring conditions reported significant decreases in test anxiety and significant increases in state mindfulness pre-postintervention, and participants in the control condition reported significant increases in test anxiety.","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Carsley', 'Affiliation': 'Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Heath', 'Affiliation': 'Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2019.1583239'] 1158,31536809,"A religiously-tailored, multilevel intervention in African American churches to increase HIV testing: Rationale and design of the Taking It to the Pews cluster randomized trial.","HIV continues to disproportionately impact African American (AA) communities. Due to delayed HIV diagnosis, AAs tend to enter HIV treatment at advanced stages. There is great need for increased access to regular HIV testing and linkage to care services for AAs. AA faith institutions are highly influential and have potential to increase the reach of HIV testing in AA communities. However, well-controlled full-scale trials have not been conducted in the AA church context. We describe the rationale and design of a 2-arm cluster randomized trial to test a religiously-tailored HIV testing intervention (Taking It to the Pews [TIPS]) against a standard information arm on HIV testing rates among AA church members and community members they serve. Using a community-engaged approach, TIPS intervention components are delivered by trained church leaders via existing multilevel church outlets using religiously-tailored HIV Tool Kit materials and activities (e.g., sermons, responsive readings, video/print testimonials, HIV educational games, text messages) to encourage testing. Church-based HIV testing events and linkage to care services are conducted by health agency partners. Control churches receive standard, non-tailored HIV information via multilevel church outlets. Secondarily, HIV risk/protective behaviors and process measures on feasibility, fidelity, and dose/exposure are assessed. This novel study is the first to fully test an HIV testing intervention in AA churches - a setting with great reach and influence in AA communities. It could provide a faith-community engagement model for delivering scalable, wide-reaching HIV prevention interventions by supporting AA faith leaders with religiously-appropriate HIV toolkits and health agency partners.",2019,There is great need for increased access to regular HIV testing and linkage to care (LTC) services for AAs.,"['African American churches', 'AA churches - a setting with great reach and influence in AA communities']","['Control churches receive standard HIV education information', 'religiously-tailored HIV testing intervention (Taking It to the Pews [TIPS']","['feasibility, fidelity, and dose/exposure', 'HIV testing rates']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}]",,0.0373933,There is great need for increased access to regular HIV testing and linkage to care (LTC) services for AAs.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berkley-Patton', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America. Electronic address: berkleypattonj@umkc.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bowe Thompson', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City & Schools of Medicine and Pharmacy, University of Missouri-Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City & Department of Pediatrics, University of Missouri, Kansas City, MO, United States of America.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'The Institute for Community Research, Hartford, CT, United States of America.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Derose', 'Affiliation': 'Pardee RAND Graduate School, RAND Corporation, Santa Monica, CA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Center for Health Communication Research, School of Public Health, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Allsworth', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Simon', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105848'] 1159,31633520,Comparison of the effects of two different teaching methods in blood pressure measurement training: a randomized controlled study.,"OBJECTIVE To compare the effects of a high-fidelity simulator and conventional teaching model used during blood pressure measurement training on students' self-confidence, self-efficacy and anxiety levels. METHODS A randomized controlled trial design was used. The study was conducted on 59 first-year nursing students of a university in Amasya, Turkey. 'Self-Confidence Scale,' 'general Self-Efficacy Scale' and 'Beck Anxiety Scale' were used to collect the data. A high-fidelity simulator used in blood pressure measurement training was applied to the experimental group, while the conventional method in which the students practice on their peers was applied to the control group. Chi-square, Mann-Whitney U test and the Wilcoxon signed-rank test were used to determine the difference between the two groups' average. RESULTS No statistically significant difference was found between students' pre-test and post-test total scores of self-confidence, general self-efficacy and anxiety scales with the high-fidelity simulator and the conventional model (P > 0.05). A significant increase was noted in inner self-confidence and self-efficacy scores of the group working on the high-fidelity simulator (P < 0.05). CONCLUSIONS The high-fidelity simulator was effective on the students' increased levels of self-confidence and self-efficacy, whereas it was not effective on their anxiety levels. However, this study can also be conducted on a larger sample group using a variety of training methods.",2019,"No statistically significant difference was found between students' pre-test and post-test total scores of self-confidence, general self-efficacy and anxiety scales with the high-fidelity simulator and the conventional model (P > 0.05).","['59 first-year nursing students of a university in Amasya, Turkey. ']",['high-fidelity simulator and conventional teaching model used during blood pressure measurement training'],"['inner self-confidence and self-efficacy scores', 'blood pressure measurement training', ""students' self-confidence, self-efficacy and anxiety levels"", ""students' pre-test and post-test total scores of self-confidence, general self-efficacy and anxiety scales"", ""Self-Confidence Scale,' 'general Self-Efficacy Scale' and 'Beck Anxiety Scale"", 'levels of self-confidence and self-efficacy']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0211908,"No statistically significant difference was found between students' pre-test and post-test total scores of self-confidence, general self-efficacy and anxiety scales with the high-fidelity simulator and the conventional model (P > 0.05).","[{'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Terzi', 'Affiliation': 'Akdeniz University, Faculty of Nursing, Akdeniz University Dumlupinar Bulvari, Akdeniz Üniversitesi Yerleşkesi Konyaalti, Antalya.'}, {'ForeName': 'Eylem', 'Initials': 'E', 'LastName': 'Topbaş', 'Affiliation': 'Amasya University, Faculty of Health Sciences, Amasya University İpekköy Yerleşkesi Shell karşisi İpekköy/Amasya, Turkey.'}, {'ForeName': 'Gülay', 'Initials': 'G', 'LastName': 'Bingöl', 'Affiliation': 'Amasya University, Faculty of Health Sciences, Amasya University İpekköy Yerleşkesi Shell karşisi İpekköy/Amasya, Turkey.'}, {'ForeName': 'Saadet Gonca', 'Initials': 'SG', 'LastName': 'Mavi Aydoğdu', 'Affiliation': 'Amasya University, Faculty of Health Sciences, Amasya University İpekköy Yerleşkesi Shell karşisi İpekköy/Amasya, Turkey.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000401'] 1160,31714371,Number of Previous Absences Is a Predictor of Sustained Attendance After Return-to-Work in Workers With Absence due to Common Mental Disorders: A Cohort 3-Year Study.,"OBJECTIVE This study evaluated the relationship of the number of previous episodes due to common mental disorders (CMDs) with long-term outcomes and sustainability of attendance after return-to-work (RTW). METHODS Participants were assigned to the following three groups: workers having one (Group 1), two (Group 2), and three or more (Group 3) previous episodes. Outcomes were a recurrent absence and the sustainability rate of attendance after RTW. RESULTS The sustainability rate in Group 1 was significantly higher than that in Group 3 throughout the observation period. The sustainability rates for Group 2 were significantly higher than for Group 3 at 30 and 36 months. CONCLUSIONS The number of previous episodes was shown to affect sustainability of attendance after RTW due to CMDs, indicating that repeated previous absences are a significant prognostic factor.",2020,"The sustainability rates for Group 2 were significantly higher than for Group 3 at 30 and 36 months. ","['Workers With Absence due to Common Mental Disorders', 'Participants']",[],"['sustainability rate of attendance after RTW', 'sustainability rates', 'sustainability rate']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],[],,0.0479466,"The sustainability rates for Group 2 were significantly higher than for Group 3 at 30 and 36 months. ","[{'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Mishima', 'Affiliation': 'Daihatsu Health Care Center, Ikeda-city, Osaka (Dr Mishima); Health and Counseling Center, Osaka University, Machikaneyama-cho, Toyonaka-city, Osaka (Dr Adachi); Department of Breast Surgery, Itami City Hospital, Koyaike, Itami-city, Hyogo (Dr Mishima), Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Adachi', 'Affiliation': ''}, {'ForeName': 'Chieko', 'Initials': 'C', 'LastName': 'Mishima', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001763'] 1161,30121721,Clinical study on the efficacy of LED phototherapy for pain control in an orthodontic procedure.,"Pain is an unpleasant and emotional subjective sensory experience that occurs during orthodontic procedures. Currently, LED phototherapy is an alternative to the use of laser light as analgesic agent due to similarity of response and lower cost. This case-control, quantitative, qualitative, and longitudinal study aimed to investigate the effect of IR LED phototherapy (λ846 ± 20 nm) in pain during the process of tooth separation during orthodontic treatment. After approval by the Institution Ethics Committee, 40 patients (30 female/10 male, 20-30 years old, average age 24.5 ± 2.6 years old) fulfilling the inclusion criteria entered the study and received a set of four visual analog scales (VAS) for scoring pain immediately, 48 h, 72 h, and 7 days after the insertion of the separating elastics. The patients were randomly distributed into two groups (experimental and control). The patients of experimental group received LED phototherapy (180 mW, 22 s, 4 J, 8 J/cm 2 , 0.36 W/cm 2 , spot of 0.5 cm 2 , spot diameter 0.8 cm) at the same times in which VAS was performed, and control patients were not irradiated. It was found that, in both groups, there was an increase in pain 48 h after insertion of the elastic tooth separator, decreasing 72 h after its installation and reached the lowest level of pain after 7 days. Comparison between groups showed that pain level in the LED group was always statistically significantly lower (p < 0.05), except for the time of installation (T1). The use of LED light was effective in significantly reducing the level of pain after insertion of the elastic tooth separators when compared to the control group.",2019,"Comparison between groups showed that pain level in the LED group was always statistically significantly lower (p < 0.05), except for the time of installation (T1).","['40 patients (30 female/10 male, 20-30\xa0years old, average age 24.5\u2009±\u20092.6\xa0years old) fulfilling the inclusion criteria entered the study and received a set of four', 'pain control in an orthodontic procedure', 'λ846\u2009±\u200920\xa0nm) in pain during the process of tooth separation during orthodontic treatment']","['visual analog scales (VAS', 'LED phototherapy', 'IR LED phototherapy']","['level of pain', 'pain level', 'pain 48\xa0h', 'lowest level of pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.0477519,"Comparison between groups showed that pain level in the LED group was always statistically significantly lower (p < 0.05), except for the time of installation (T1).","[{'ForeName': 'I Z', 'Initials': 'IZ', 'LastName': 'Figueira', 'Affiliation': 'Prof. José Martins Soares Édimo Center for Orthodontics and Dentofacial Orthopedics, School of Dentistry, Federal University of Bahia - UFBA, Av. Araújo Pinho, 62, Canela, Salvador, BA, 40110-150, Brazil.'}, {'ForeName': 'A P C', 'Initials': 'APC', 'LastName': 'Sousa', 'Affiliation': 'Center of Biophotonics, School of Dentistry, Federal University of Bahia - UFBA, Av. Araújo Pinho, 62, Canela, Salvador, BA, 40110-150, Brazil.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Machado', 'Affiliation': 'Prof. José Martins Soares Édimo Center for Orthodontics and Dentofacial Orthopedics, School of Dentistry, Federal University of Bahia - UFBA, Av. Araújo Pinho, 62, Canela, Salvador, BA, 40110-150, Brazil.'}, {'ForeName': 'F A L', 'Initials': 'FAL', 'LastName': 'Habib', 'Affiliation': 'Prof. José Martins Soares Édimo Center for Orthodontics and Dentofacial Orthopedics, School of Dentistry, Federal University of Bahia - UFBA, Av. Araújo Pinho, 62, Canela, Salvador, BA, 40110-150, Brazil.'}, {'ForeName': 'L G P', 'Initials': 'LGP', 'LastName': 'Soares', 'Affiliation': 'Prof. José Martins Soares Édimo Center for Orthodontics and Dentofacial Orthopedics, School of Dentistry, Federal University of Bahia - UFBA, Av. Araújo Pinho, 62, Canela, Salvador, BA, 40110-150, Brazil.'}, {'ForeName': 'A L B', 'Initials': 'ALB', 'LastName': 'Pinheiro', 'Affiliation': 'Center of Biophotonics, School of Dentistry, Federal University of Bahia - UFBA, Av. Araújo Pinho, 62, Canela, Salvador, BA, 40110-150, Brazil. albp@ufba.br.'}]",Lasers in medical science,['10.1007/s10103-018-2617-3'] 1162,31926638,"Efficacy and safety of 5 mg olanzapine combined with aprepitant, granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in patients with gynecologic cancer: A multi-institution phase II study.","PURPOSE The aim of this study was to investigate the efficacy and safety of prophylactic administration of 5 mg olanzapine (OLZ) combined with neurokinin 1 receptor antagonist (NK 1 RA), 5-hydroxytryptamine type-3 receptor antagonist (5-HT 3 RA), and dexamethasone (DEX) to prevent nausea and vomiting in carboplatin (CBDCA) combination therapy for patients with gynecological cancer. METHODS We conducted a single-arm, multi-institution, phase II study. Gynecological cancer patients scheduled to receive AUC ≥4 mg/mL/min CBDCA were enrolled. All patients received 5 mg OLZ (once daily after supper on days 1-4) combined with NK 1 RA, 5-HT 3 RA, and DEX. The primary end point was complete response (CR; no emesis and rescue therapy) during overall phase (120 h after the start of carboplatin administration). RESULTS Between May 2018 and June 2019, 60 patients were enrolled from 3 institutions in Japan. A total of 57 patients who met the criteria were included in the efficacy and safety analysis. The CR rate for the overall phase was 78.9%. Acute (0-24 h) and delayed phases (24-120 h) were 96.5% and 80.7%, respectively. Somnolence was observed in 73.7% patients. However, somnolence of grade 2 or higher was observed in only 3.5% of cases. There were no grade 3 or 4 toxicities associated with OLZ. CONCLUSIONS Preventive use of OLZ combined with standard triplet therapy had promising activity with manageable safety, suggesting that this combination could be an effective standard treatment option for patients with AUC ≥4 mg/mL/min CBDCA combination therapy.",2020,"There were no grade 3 or 4 toxicities associated with OLZ. ","['Gynecological cancer patients scheduled to receive AUC ≥4', 'patients with gynecologic cancer', 'Between May 2018 and June 2019, 60 patients were enrolled from 3 institutions in Japan', 'patients with gynecological cancer', '57 patients who met the criteria']","['olanzapine combined with aprepitant, granisetron and dexamethasone', 'olanzapine (OLZ) combined with neurokinin 1 receptor antagonist (NK 1 RA), 5-hydroxytryptamine type-3 receptor antagonist (5-HT 3 RA), and dexamethasone (DEX', 'mg/mL/min CBDCA', 'OLZ', 'carboplatin (CBDCA) combination therapy', 'OLZ combined with standard triplet therapy']","['efficacy and safety', 'Efficacy and safety', 'somnolence of grade 2 or higher', 'complete response (CR; no emesis and rescue therapy', 'CR rate', 'Somnolence', 'nausea and vomiting']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4521486', 'cui_str': 'Neurokinin 1 receptor antagonist'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",60.0,0.0784812,"There were no grade 3 or 4 toxicities associated with OLZ. ","[{'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Iihara', 'Affiliation': 'Department of Pharmacy, Gifu University Hospital, Gifu, Japan; Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, Gifu, Japan. Electronic address: dai0920@gifu-u.ac.jp.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Cancer Biostatistics Laboratory, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan; Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Yoh', 'Initials': 'Y', 'LastName': 'Hayasaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Yukiyoshi', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Division of Pharmacy, Gunma Prefectural Cancer Center, Gunma, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Division of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Takenaka', 'Affiliation': 'Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Senri', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Pharmacy, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Division of Pharmacy, Gunma Prefectural Cancer Center, Gunma, Japan.'}, {'ForeName': 'Michiru', 'Initials': 'M', 'LastName': 'Sakurai', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gynecology, Gunma Prefectural Cancer Center, Gunma, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Kado', 'Affiliation': 'Division of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Murase', 'Affiliation': 'Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Shimaoka', 'Affiliation': 'Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pharmacy, Gifu University Hospital, Gifu, Japan; Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, Gifu, Japan.'}, {'ForeName': 'Ken-Ichirou', 'Initials': 'KI', 'LastName': 'Morishige', 'Affiliation': 'Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, Gifu, Japan.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.01.004'] 1163,32407242,Exogenous ketosis impacts neither performance nor muscle glycogen breakdown in prolonged endurance exercise.,"Available evidence indicates that ketone bodies inhibit glycolysis in contracting muscles. Therefore, we investigated whether acute exogenous ketosis by oral ketone ester (KE) intake early in a simulated cycling race can induce transient glycogen sparing by glycolytic inhibition, thereby increasing glycogen availability in the final phase of the event. In a randomized crossover design, 12 highly trained male cyclists completed a simulated cycling race (RACE), which consisted of 3-h intermittent cycling (IMT 180' ), a 15-min time trial (TT 15' ), and a maximal sprint (SPRINT). During RACE, subjects received 60 g carbohydrates/h combined with three boluses (25, 20, and 20 g) ( R )-3-hydroxybutyl ( R )-3-hydroxybutyrate (KE) or a control drink (CON) at 60 and 20 min before and at 30 min during RACE. KE intake transiently increased blood d-β-hydroxybutyrate to ~3 mM (range: 2.6-5.2 mM) during the first half of RACE ( P < 0.001 vs. CON). Blood pH concomitantly decreased from approximately 7.42 to 7.36 (range: 7.29-7.40), whereas bicarbonate dropped from 26.0 to 21.6 mM (range: 20.1-23.7; both P < 0.001 vs. CON) . Net muscle glycogen breakdown during IMT 180' [KE: -78 ± 30 (SD); CON: -60 ± 22 mmol/kg wet wt; P = 0.08] and TT 15' (KE: -9 ± 18; CON: -18 ± 18 mmol/kg wet wt; P = 0.35) was similar between KE and CON. Accordingly, mean power output during TT 15' (KE: 273 ± 38; CON: 272 ± 37 W; P = 0.83) and time-to-exhaustion in the SPRINT (KE: 59 ± 16; CON: 58 ± 17 s; P = 0.66) were similar between conditions. In conclusion, KE intake during a simulated cycling race does not cause glycogen sparing, nor does it affect all-out performance in the final stage of a simulated race. NEW & NOTEWORTHY Exogenous ketosis produced by oral ketone ester ingestion during the early phase of prolonged endurance exercise and against the background of adequate carbohydrate intake neither causes muscle glycogen sparing nor improves performance in the final stage of the event. However, such exogenous ketosis may decrease buffering capacity in the approach of the final episode of the event. Furthermore, ketone ester intake during exercise may reduce appetite immediately after exercise.",2020,"CON: -60±22 mmol/kg ww, p=0.08) and TT 15' (KE: -9±18; CON: -18±18 mmol/kg ww, p=0.35) was similar between KE and CON.",['12 highly-trained male cyclists completed a simulated cycling race (RACE'],"[""IMT 180' (KE: -78±30 (SD"", 'R)-3-hydroxybutyl (R)-3-hydroxybutyrate (KE) or a control drink (CON', 'oral ketone ester (KE', 'maximal sprint (SPRINT']","['time-to-exhaustion', 'Blood pH', 'Net muscle glycogen breakdown']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C3529323', 'cui_str': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0596624', 'cui_str': 'Glycogenolysis'}]",,0.132524,"CON: -60±22 mmol/kg ww, p=0.08) and TT 15' (KE: -9±18; CON: -18±18 mmol/kg ww, p=0.35) was similar between KE and CON.","[{'ForeName': 'Chiel', 'Initials': 'C', 'LastName': 'Poffé', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ramaekers', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hespel', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00092.2020'] 1164,31561882,Cost-effectiveness Analysis of Empagliflozin in Japan Based on Results From the Asian subpopulation in the EMPA-REG OUTCOME Trial.,"PURPOSE The goal of this study was to assess the cost-effectiveness of empagliflozin in Japan based on the Asian subpopulation in the EMPA-REG OUTCOME trial. METHODS The trial has shown a reduction in the risk for cardiovascular (CV) and renal events with empagliflozin in patients with type 2 diabetes mellitus and established CV disease. A cost-effectiveness analysis based on the overall population of the EMPA-REG OUTCOME trial was reported previously by using a lifetime discrete event simulation model. The same modeling frame was adapted to evaluate the cost-effectiveness of treatment with empagliflozin added to standard of care (SoC) compared with SoC alone in Japan. The time to relevant clinical events and the hazard ratios were derived from an Asian subpopulation in the EMPA-REG OUTCOME trial. The costs for each event were estimated from a Japanese medical claims database. Direct medical costs, life expectancy, and quality-adjusted life years (QALYs) were calculated from the public health care perspective. FINDINGS Treatment with empagliflozin was estimated to increase life expectancy by 6.2 years and 2.7 QALYs, whereas total cost increased by 1,115,475 yen compared with treatment with SoC alone. The incremental cost-effectiveness ratio was 415,849 yen/QALY. In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY). IMPLICATIONS Based on the Asian subpopulation in the EMPA-REG OUTCOME trial, our results suggest that empagliflozin added to SoC is highly cost-effective compared with SoC alone in Japan.",2019,"In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY). ","['Japan', 'Japan based on the Asian population in the EMPA-REG OUTCOME trial', 'patients with type 2 diabetes mellitus and established CV disease', 'in Japan']","['Empagliflozin', 'empagliflozin', 'SoC alone']","['Direct medical costs, life expectancy, and quality-adjusted life years (QALYs', 'incremental cost-effectiveness ratio', 'total cost', 'cost-effectiveness', 'life expectancy']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0407188,"In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY). ","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Haneda', 'Affiliation': 'Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sakamaki', 'Affiliation': 'Kanagawa University of Human Services School of Health Innovation, Kawasaki, Japan.'}, {'ForeName': 'Atsutaka', 'Initials': 'A', 'LastName': 'Yasui', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan. Electronic address: atsutaka.yasui@boehringer-ingelheim.com.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Murata', 'Affiliation': 'CRECON Medical Assessment Inc, Tokyo, Japan.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ustyugova', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim/Rhein, Germany.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Chin', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Tetsuaki', 'Initials': 'T', 'LastName': 'Hirase', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Tsunehisa', 'Initials': 'T', 'LastName': 'Shibahara', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Anuraag', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim/Rhein, Germany.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.016'] 1165,30955478,The effect of educational text message based on health belief model on osteoporosis preventive behaviors in women: a randomized controlled clinical trial.,"The purpose of this study was to investigate the effect of educational text messages, based on the health belief model, on osteoporosis preventive behaviors among women aged 30-45 years. This trial was conducted on 121 women from November until September 2017 in Shabestar, Iran. The intervention group received a daily educational text message about osteoporosis for one month, and the control group received educational text messages on frequently occurring cancers in women. Two months after the training, data were collected using the osteoporosis health belief scale, a food frequency questionnaire and the International Physical Activity Questionnaire. No significant differences were observed at baseline between the two groups, except for the perceived benefits construct. After the intervention, controlling for baseline score and adjusting for educational level, a statistically significant difference was observed between the two groups in HBM structures and nutrition performance, while no significant difference was observed in physical activity between the two groups. This study showed that educational text messages can be effective in increasing awareness, perceived susceptibility and severity, and nutritional behavior change related to risk of osteoporosis.",2019,"This study showed that educational text messages can be effective in increasing awareness, perceived susceptibility and severity, and nutritional behavior change related to risk of osteoporosis.","['121 women from November until September 2017 in Shabestar, Iran', 'women aged 30-45\xa0years', 'women']","['daily educational text message about osteoporosis for one month, and the control group received educational text messages', 'educational text messages', 'educational text message']","['HBM structures and nutrition performance', 'physical activity', 'osteoporosis health belief scale, a food frequency questionnaire and the International Physical Activity Questionnaire']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0222045'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",121.0,0.0321182,"This study showed that educational text messages can be effective in increasing awareness, perceived susceptibility and severity, and nutritional behavior change related to risk of osteoporosis.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Parandeh', 'Affiliation': ""Department of Midwifery, Students' Research Committee, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Fahimeh Sehhati', 'Initials': 'FS', 'LastName': 'Shafaie', 'Affiliation': 'Nursing and Midwifery Faculty, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Malakouti', 'Affiliation': 'Nursing and Midwifery Faculty, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Nursing and Midwifery Faculty, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Biostatistics, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Women & health,['10.1080/03630242.2019.1590495'] 1166,30943128,¡Activate Ya! Co-learning about school-based tobacco prevention and physical activity promotion in secondary school students in Uruguay.,"PURPOSE ¡Activate Ya! was a group-randomized controlled intervention trial aimed at developing and evaluating the impact of a school-based intervention on preventing cigarette smoking and promoting physical activity (PA) in secondary school students in Uruguay. Secondary aims were to evaluate the program's impact on students' smoking- and PA-related psychosocial risk and protective factors. METHODS Sixteen schools and n = 654 students participated in the study. The one-year intervention included a classroom-based curriculum, an afterschool program, activity breaks, and final showcase event. A self-administered questionnaire measured outcomes at three time points. Fixed effects regression models tested for differences in outcomes by study condition. RESULTS While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected. Past 7-day PA, measured by the PAQ-C, was significantly higher among intervention school students overall ( p = .048) and for girls ( p = .03) at posttest, and intervention girls reported significantly higher athletic identity PA competence, friend and teacher PA support at posttest, and PA enjoyment at follow-up ( p < .05). CONCLUSION The positive short-term effects of ¡Activate Ya! on PA and related outcomes for girls support the utility of school-based health promotion in Uruguay. Additional research is needed to determine the most effective strategies to prevent tobacco use among students and promote PA among boys in this setting.",2020,"While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected.","['\n\n\nSixteen schools and n = 654 students participated in the study', 'secondary school students in Uruguay']","['school-based intervention', 'classroom-based curriculum, an afterschool program, activity breaks, and final showcase event', 'Activate Ya', 'Activate Ya! Co-learning about school-based tobacco prevention and physical activity promotion']","['cigarette smoking and promoting physical activity (PA', ""students' smoking- and PA-related psychosocial risk and protective factors"", 'athletic identity PA competence, friend and teacher PA support at posttest, and PA enjoyment', 'selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0042113', 'cui_str': 'Uruguay'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}]",654.0,0.0188797,"While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected.","[{'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Springer', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Harrell', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Martínez Gomensoro', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Traversa Fresco', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Florines', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Joowon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Perry', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bianco', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Estol', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}]",Global health promotion,['10.1177/1757975918813049'] 1167,30910410,Randomized double-blind clinical trial evaluation of bone healing after third molar surgery with the use of leukocyte- and platelet-rich fibrin.,"The objective of this study was to evaluate the use of leukocyte- and platelet-rich fibrin (L-PRF) in bone healing after mandibular third molar extraction. In this prospective, double-blind, split-mouth study, 34 extractions were performed. On one side, the socket was sutured primarily (control side); on the other side, L-PRF was inserted before suturing. The patients were assessed for postoperative bone regeneration, pain and soft tissue healing. The primary outcome was bone regeneration, which was performed through tomographic evaluation in the immediate postoperative period and 3 months after the procedure. The ITK-SNAP software was used for image evaluation by the intensity of grey of each voxel. Pain was analysed using a visual analogue scale (VAS), and soft tissue healing was analysed both based on the modified healing index of Landry et al., and by comparing pre- and postoperative periodontal probing at the distal of the lower second molar. The application of L-PRF improved bone density, which was higher in test group (p=0.007). There was no statistical difference related to pain or soft tissue between the groups (p>0.05). There was evidence for improved bone healing in response to L-PRF. However, to better understand the effect of L-PRF more clinical trials with larger samples are necessary.",2019,"The application of L-PRF improved bone density, which was higher in test group (p=0.007).",['bone healing after mandibular third molar extraction'],"['leukocyte- and platelet-rich fibrin', 'leukocyte- and platelet-rich fibrin (L-PRF']","['bone healing', 'visual analogue scale (VAS), and soft tissue healing', 'Pain', 'postoperative bone regeneration, pain and soft tissue healing', 'pain or soft tissue', 'bone density', 'bone regeneration']","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C4505052', 'cui_str': 'L-PRF'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",34.0,0.190128,"The application of L-PRF improved bone density, which was higher in test group (p=0.007).","[{'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Ritto', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pimentel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil. Electronic address: pimentelthais@outlook.com.'}, {'ForeName': 'J V S', 'Initials': 'JVS', 'LastName': 'Canellas', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Junger', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Medeiros', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.01.020'] 1168,30916381,"Assessment of the effects of immunogenicity on the pharmacokinetics, efficacy and safety of tildrakizumab.","BACKGROUND We evaluated antidrug antibody (ADA) development in patients with chronic plaque psoriasis from three clinical trials of tildrakizumab, a humanized anti-interleukin-23p19 monoclonal antibody (P05495, reSURFACE 1 and reSURFACE 2). OBJECTIVES To determine the effects of immunogenicity on the pharmacokinetics, efficacy and safety of tildrakizumab. METHODS In 1400 (weeks 12-16) and 780 (weeks 52-64) evaluable patients randomized to tildrakizumab 100 or 200 mg, treatment-emergent ADA-positive (TE-POS) patients were identified and characterized for neutralizing antibodies (NAbs). Pharmacokinetics, safety and efficacy were evaluated by ADA status. RESULTS In patients treated with tildrakizumab 100 or 200 mg continuously, < 7% were inconclusive at 52-64 weeks. In long-term data through 52-64 weeks, the incidence of TE-POS was 6·5% (100 mg) and 8·2% (200 mg) and the incidence of TE-POS NAb-POS was 2·5% (100 mg) and 3·2% (200 mg). TE-POS NAb-POS patients had modestly increased median tildrakizumab clearance (36·5%) compared with ADA-NEG patients. Percentage Psoriasis Area and Severity Index improvements in TE-POS NAb-POS vs. ADA-NEG patients on continuous treatment through week 52 were 76% (n = 10) vs. 91% (n = 342) for 100 mg and 77% (n = 12) vs. 87% (n = 299) for 200 mg. The incidence of potential immunogenicity-related adverse events did not indicate a clear trend in any positive ADA patient category compared with ADA-NEG patients through weeks 52-64. The effects of ADA on pharmacokinetics, efficacy and safety at 12-16 weeks were also summarized. CONCLUSIONS ADA development with tildrakizumab treatment for 52-64 weeks was low; around 3% of patients developed TE-POS NAb-POS ADAs and showed lower serum concentrations and corresponding reduced efficacy. No relationship between ADAs and safety was observed. What's already known about this topic? Unwanted immune responses - for example immunogenicity and antidrug antibodies (ADAs) - have been observed with therapeutic monoclonal antibodies and can affect efficacy and safety. Tildrakizumab is a humanized monoclonal antibody targeting interleukin-23 and is currently approved for patients with plaque psoriasis. What does this study add? ADA development in tildrakizumab-treated patients with psoriasis over 52 weeks was low. The small proportion of patients who had treatment-emergent ADAs and had neutralizing antibodies experienced lower serum tildrakizumab concentrations and reduced efficacy. No relationship between ADAs and safety events was observed.",2020,The incidence of potential immunogenicity-related adverse events did not indicate a clear trend in any positive ADA patient category compared with ADA-NEG patients through weeks 52-64.,['patients with chronic plaque psoriasis'],"['tildrakizumab 100 or 200 mg, treatment-emergent ADA-positive (TE-POS', 'tildrakizumab', 'ADA']","['Percentage Psoriasis Area and Severity Index improvements', 'median tildrakizumab clearance', 'pharmacokinetics, efficacy and safety', 'ADAs and safety', 'potential immunogenicity-related adverse events', 'serum concentrations', 'incidence of TE-POS', 'Pharmacokinetics, safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0484722,The incidence of potential immunogenicity-related adverse events did not indicate a clear trend in any positive ADA patient category compared with ADA-NEG patients through weeks 52-64.,"[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Kimball', 'Affiliation': 'Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kerbusch', 'Affiliation': 'Certara U.S.A., Inc., Princeton, NJ, U.S.A.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'van Aarle', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Certara U.S.A., Inc., Princeton, NJ, U.S.A.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation center, Hamburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Montgomery', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17918'] 1169,31714309,Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.,"BACKGROUND Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections. METHODS Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI). FINDINGS In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection. INTERPRETATION Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.",2020,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"['healthy patient group', 'Eligible donors', '293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm', 'Renal Donation (POWAR']","['hand-assisted laparoscopic donor nephrectomy (HALDN', 'Placebo', 'preoperative single-dose intravenous co-amoxiclav or saline', 'placebo']","['clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI', 'LRTIs', 'Superficial SSIs', 'total infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",293.0,0.709113,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"[{'ForeName': 'Zubir', 'Initials': 'Z', 'LastName': 'Ahmed', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Uwechue', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chandak', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Dellen', 'Affiliation': 'Dept of Renal and Pancreas Transplantation, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Barwell', 'Affiliation': 'Renal Transplant Unit, Derriford Hospital, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heap', 'Affiliation': ""Renal Transplant Unit, St. George's Hospital, London, UK.""}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Szabo', 'Affiliation': ""Department of Microbiology and Infection, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hemsley', 'Affiliation': 'Department of Nephrology & Transplant Surgery, University Hospital of Wales, Cardiff & Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Olsburgh', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Kessaris', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nizam', 'Initials': 'N', 'LastName': 'Mamode', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}]",Annals of surgery,['10.1097/SLA.0000000000003666'] 1170,32407216,Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung Cancer.,"PURPOSE To evaluate the efficacy of pemetrexed plus cisplatin versus vinorelbine plus cisplatin as postoperative adjuvant chemotherapy in patients with pathologic stage II-IIIA nonsquamous non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan. Patients with completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC were randomly assigned to receive either pemetrexed (500 mg/m 2 , day 1) plus cisplatin (75 mg/m 2 , day 1) or vinorelbine (25 mg/m 2 , days 1 and 8) plus cisplatin (80 mg/m 2 , day 1) with stratification by sex, age, pathologic stage, EGFR mutation, and institution. These treatments were planned to be given every 3 weeks for 4 cycles. The primary end point was recurrence-free survival in the modified intent-to-treat population, excluding ineligible patients. RESULT Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin). Of 784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had EGFR -sensitive mutations. At a median follow-up of 45.2 months, median recurrence-free survival was 37.3 months for vinorelbine plus cisplatin and 38.9 months for pemetrexed plus cisplatin, with a hazard ratio of 0.98 (95% CI, 0.81 to 1.20; 1-sided P = .474). Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively). One treatment-related death occurred in each arm. CONCLUSION Although this study failed to show the superiority of pemetrexed plus cisplatin for patients with resected nonsquamous NSCLC, this regimen showed a better tolerability as adjuvant chemotherapy.",2020,"Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively).","['nonsquamous NSCLC', 'patients with pathologic stage II-IIIA nonsquamous non-small-cell lung cancer (NSCLC', 'We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan', '784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had EGFR -sensitive mutations', 'Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung Cancer', 'Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to', 'patients with resected nonsquamous NSCLC', 'Patients with completely resected pathologic stage II-IIIA (TNM 7th edition']","['vinorelbine', 'Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin', 'cisplatin', 'vinorelbine plus cisplatin', 'pemetrexed plus cisplatin', 'vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin', 'pemetrexed']","['febrile neutropenia', 'neutropenia', 'death', 'anemia', 'recurrence-free survival', 'Grade 3-4 toxicities', 'median recurrence-free survival']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",804.0,0.219795,"Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively).","[{'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Katsuo', 'Initials': 'K', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Chest Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Thoracic Surgery, National Hospital Organization, Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Toyooka', 'Affiliation': 'Department of General Thoracic Surgery, Breast and Endocrinological Surgery, Okayama University, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Date', 'Affiliation': 'Department of Thoracic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yokoi', 'Affiliation': 'Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02674'] 1171,31701526,Brief Report on PROSPER Academic Outcomes: Extended Model of Crossover Effects on Young Adult College Success.,"This study examines crossover effects of adolescent substance misuse preventive interventions on academic success in college. It evaluates pathways of influence on college grades, via effects on school engagement, problem-solving skills, and substance misuse in high school. Data were collected as part of an Randomized Controlled Trial (RCT) evaluating a multicomponent intervention conducted in 28 school districts with middle school students. At age 19, study participants (N = 1,488) enrolled in college reported on college grades. The model fit the data, supporting hypothesized pathways of intervention impacts. Inclusion of a significant direct effect on college grades further improved model fit. Results support the potential for universal substance misuse preventive interventions delivered by community partnerships during middle school to yield effects on long-term academic success.",2019,"It evaluates pathways of influence on college grades, via effects on school engagement, problem-solving skills, and substance misuse in high school.","['college', 'Young Adult College Success', 'At age 19, study participants (N\xa0=\xa01,488) enrolled in college reported on college grades', '28 school districts with middle school students']",['adolescent substance misuse preventive interventions'],"['academic success', 'school engagement, problem-solving skills, and substance misuse']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0700132', 'cui_str': 'Academic Success'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}]",1488.0,0.0199592,"It evaluates pathways of influence on college grades, via effects on school engagement, problem-solving skills, and substance misuse in high school.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Spoth', 'Affiliation': 'Iowa State University.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Trudeau', 'Affiliation': 'Iowa State University.'}, {'ForeName': 'Cleve', 'Initials': 'C', 'LastName': 'Redmond', 'Affiliation': 'Iowa State University.'}, {'ForeName': 'Chungyeol', 'Initials': 'C', 'LastName': 'Shin', 'Affiliation': 'Iowa State University.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Feinberg', 'Affiliation': 'Pennsylvania State University.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Greenberg', 'Affiliation': 'Pennsylvania State University.'}]",Child development,['10.1111/cdev.13321'] 1172,29948856,Diet associated with exercise improves baroreflex control of sympathetic nerve activity in metabolic syndrome and sleep apnea patients.,"PURPOSE We tested the hypothesis that (i) diet associated with exercise would improve arterial baroreflex (ABR) control in metabolic syndrome (MetS) patients with and without obstructive sleep apnea (OSA) and (ii) the effects of this intervention would be more pronounced in patients with OSA. METHODS Forty-six MetS patients without (noOSA) and with OSA (apnea-hypopnea index, AHI > 15 events/h) were allocated to no treatment (control, C) or hypocaloric diet (- 500 kcal/day) associated with exercise (40 min, bicycle exercise, 3 times/week) for 4 months (treatment, T), resulting in four groups: noOSA-C (n = 10), OSA-C (n = 12), noOSA-T (n = 13), and OSA-T (n = 11). Muscle sympathetic nerve activity (MSNA), beat-to-beat BP, and spontaneous arterial baroreflex function of MSNA (ABR MSNA , gain and time delay) were assessed at study entry and end. RESULTS No significant changes occurred in C groups. In contrast, treatment in both patients with and without OSA led to a significant decrease in weight (P < 0.05) and the number of MetS factors (P = 0.03). AHI declined only in the OSA-T group (31 ± 5 to 17 ± 4 events/h, P < 0.05). Systolic BP decreased in both treatment groups, and diastolic BP decreased significantly only in the noOSA-T group. Treatment decreased MSNA in both groups. Compared with baseline, ABR MSNA gain increased in both OSA-T (13 ± 1 vs. 24 ± 2 a.u./mmHg, P = 0.01) and noOSA-T (27 ± 3 vs. 37 ± 3 a.u./mmHg, P = 0.03) groups. The time delay of ABR MSNA was reduced only in the OSA-T group (4.1 ± 0.2 s vs. 2.8 ± 0.3 s, P = 0.04). CONCLUSIONS Diet associated with exercise improves baroreflex control of sympathetic nerve activity and MetS components in patients with MetS regardless of OSA.",2019,"AHI declined only in the OSA-T group (31 ± 5 to 17 ± 4 events/h, P < 0.05).","['metabolic syndrome (MetS) patients with and without obstructive sleep apnea (OSA) and (ii', 'Forty-six MetS patients without (noOSA) and with OSA (apnea-hypopnea index, AHI >\u200915\xa0events/h', 'metabolic syndrome and sleep apnea patients', 'patients with MetS regardless of OSA']","['hypocaloric diet (-\u2009500\xa0kcal/day) associated with exercise (40\xa0min, bicycle exercise']","['AHI', 'Muscle sympathetic nerve activity (MSNA), beat-to-beat BP, and spontaneous arterial baroreflex function of MSNA (ABR MSNA , gain and time delay', 'MSNA', 'time delay of ABR MSNA', 'Systolic BP', 'baroreflex control of sympathetic nerve activity and MetS components', 'diastolic BP', 'arterial baroreflex (ABR) control', 'number of MetS factors', 'ABR MSNA gain', 'weight']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",46.0,0.0133989,"AHI declined only in the OSA-T group (31 ± 5 to 17 ± 4 events/h, P < 0.05).","[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Toschi-Dias', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil. edgardias@usp.br.'}, {'ForeName': 'Ivani C', 'Initials': 'IC', 'LastName': 'Trombetta', 'Affiliation': 'Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'Valdo J D', 'Initials': 'VJD', 'LastName': 'Silva', 'Affiliation': 'Biological Sciences Institute, Triangulo Mineiro Federal University, Uberaba, MG, Brazil.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'Maki-Nunes', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Felipe X', 'Initials': 'FX', 'LastName': 'Cepeda', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Janieire N N', 'Initials': 'MJNN', 'LastName': 'Alves', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Glauce L', 'Initials': 'GL', 'LastName': 'Carvalho', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Negrão', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Urbana P B', 'Initials': 'MUPB', 'LastName': 'Rondon', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1675-x'] 1173,30911991,"Bacillus coagulans Unique IS2 in Constipation: A Double-Blind, Placebo-Controlled Study.","Functional constipation has a high prevalence in both adults and children affecting quality of life. Evidence suggests that probiotics can reduce the symptoms of constipation. As the effects of probiotics are strain specific, the efficacy of Bacillus coagulans Unique IS2 in the treatment of functional constipation in adults was evaluated. Subjects (n = 100) diagnosed with functional constipation were supplemented with either B. coagulans Unique IS2 (2 billion CFU) or placebo capsules once daily for 4 weeks. Subjects were evaluated for treatment success (defined as three or more spontaneous stools per week), stool consistency, difficulty of defecation, defecation and abdominal pain. By the end of the fourth week, there was a statistically significant (p < 0.001) increase in number of bowel movements in the probiotic treated group as compared to placebo. Ninety eight percent of subjects in the probiotic group achieved normal stool consistency as compared to placebo (74%). Moreover, there was relief from symptoms of incomplete evacuation, painful defecation and abdominal pain associated with constipation in probiotic treated group as compared to placebo. In conclusion, B. coagulans Unique IS2 significantly decreased the symptoms of constipation indicating effectiveness of the strain in the treatment of constipation.Trial registration: CTRI/2017/11/010539.",2020,"By the end of the fourth week, there was a statistically significant (p < 0.001) increase in number of bowel movements in the probiotic treated group as compared to placebo.","['Bacillus coagulans Unique IS2 in Constipation', 'Subjects (n\u2009=\u2009100) diagnosed with functional constipation']","['Placebo', 'placebo']","['number of bowel movements', 'stool consistency, difficulty of defecation, defecation and abdominal pain', 'normal stool consistency', 'symptoms of constipation', 'relief from symptoms of incomplete evacuation, painful defecation and abdominal pain associated with constipation']","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0237326', 'cui_str': 'Dyschezia'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]",,0.116527,"By the end of the fourth week, there was a statistically significant (p < 0.001) increase in number of bowel movements in the probiotic treated group as compared to placebo.","[{'ForeName': 'Ratna Sudha', 'Initials': 'RS', 'LastName': 'Madempudi', 'Affiliation': 'Centre for Research and Development, Unique Biotech Ltd., Plot No. 2, Phase II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India. sudha@uniquebiotech.com.'}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Neelamraju', 'Affiliation': 'Centre for Research and Development, Unique Biotech Ltd., Plot No. 2, Phase II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Jayesh J', 'Initials': 'JJ', 'LastName': 'Ahire', 'Affiliation': 'Centre for Research and Development, Unique Biotech Ltd., Plot No. 2, Phase II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Sandeep K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Paediatrics, MV Hospital and Research Centre, First Floor, Room No. 01 314/30 Mirza Mandi Chowk, Lucknow, Uttar Pradesh, 226003, India.'}, {'ForeName': 'Vineet K', 'Initials': 'VK', 'LastName': 'Shukla', 'Affiliation': 'Department of Paediatrics, KRM Hospital and Research Centre, First Floor, Room No. 01 3/92-93 Vijayant Khand, Lucknow, Uttar Pradesh, 226010, India.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-019-09542-9'] 1174,30955420,Don't Fear the Reefer-Evidence Mounts for Plant-Based Cannabidiol as Treatment for Epilepsy.,"Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome Devinsky O, Patel AD, Cross JH, et al; GWPCARE3 Study Group. N Engl J Med. 2018;378:1888-1897. BACKGROUND Cannabidiol has been used for treatment-resistant seizures in patients with severe early-onset epilepsy. We investigated the efficacy and safety of cannabidiol added to a regimen of conventional antiepileptic medication to treat drop seizures in patients with the Lennox-Gastaut syndrome, a severe developmental epileptic encephalopathy. METHODS In this double-blind, placebo-controlled trial conducted at 30 clinical centers, we randomly assigned patients with the Lennox-Gastaut syndrome (age range, 2-55 years) who had had 2 or more drop seizures per week during a 28-day baseline period to receive cannabidiol oral solution at a dose of 20 mg/kg of body weight (20-mg cannabidiol group) or 10 mg/kg (10-mg cannabidiol group) or matching placebo, administered in 2 equally divided doses daily for 14 weeks. The primary outcome was the percentage change from baseline in the frequency of drop seizures (average per 28 days) during the treatment period. RESULTS A total of 225 patients were enrolled; 76 patients were assigned to the 20-mg cannabidiol group, 73 to the 10-mg cannabidiol group, and 76 to the placebo group. During the 28-day baseline period, the median number of drop seizures was 85 in all trial groups combined. The median percentage reduction from baseline in drop seizure frequency during the treatment period was 41.9% in the 20-mg cannabidiol group, 37.2% in the 10-mg cannabidiol group, and 17.2% in the placebo group ( P = .005 for the 20-mg cannabidiol group vs placebo group, and P = .002 for the 10-mg cannabidiol group vs placebo group). The most common adverse events among the patients in the cannabidiol groups were somnolence, decreased appetite, and diarrhea; these events occurred more frequently in the higher dose group. Six patients in the 20-mg cannabidiol group and 1 patient in the 10-mg cannabidiol group discontinued the trial medication because of adverse events and were withdrawn from the trial. Fourteen patients who received cannabidiol (9%) had elevated liver aminotransferase concentrations. CONCLUSIONS Among children and adults with the Lennox-Gastaut syndrome, the addition of cannabidiol at a dose of 10 or 20 mg/kg/d to a conventional antiepileptic regimen resulted in greater reductions in the frequency of drop seizures than placebo. Adverse events with cannabidiol included elevated liver aminotransferase concentrations. (Funded by GW Pharmaceuticals; GWPCARE3 ClinicalTrials.gov number, NCT02224560.) Long-Term Safety and Treatment Effects of Cannabidiol in Children and Adults With Treatment-Resistant Epilepsies: Expanded Access Program Results Szaflarski JP, Bebin EM, Comi AM, et al; CBD EAP Study Group. Epilepsia. 2018;59(8):1540-1548. OBJECTIVE Since 2014, cannabidiol (CBD) has been administered to patients with treatment-resistant epilepsies (TREs) in an ongoing expanded access program (EAP). We report interim results on the safety and efficacy of CBD in EAP patients treated through December 2016. METHODS Twenty-five US-based EAP sites enrolling patients with TRE taking stable doses of antiepileptic drugs (AEDs) at baseline were included. During the 4-week baseline period, parents/caregivers kept diaries of all countable seizure types. Patients received oral CBD starting at 2 to 10 mg/kg/d, titrated to a maximum dose of 25 to 50 mg/kg/d. Patient visits were every 2 to 4 weeks through 16 weeks and every 2 to 12 weeks thereafter. Efficacy end points included the percentage change from baseline in median monthly convulsive and total seizure frequency and percentage of patients with ≥50%, ≥75%, and 100% reductions in seizures versus baseline. Data were analyzed descriptively for the efficacy analysis set and using the last-observation-carried-forward method to account for missing data. Adverse events (AEs) were documented at each visit. RESULTS Of 607 patients in the safety data set, 146 (24%) withdrew; the most common reasons were lack of efficacy (89 [15%]) and AEs (32 [5%]). Mean age was 13 years (range, 0.4-62). Median number of concomitant AEDs was 3 (range, 0-10). Median CBD dose was 25 mg/kg/d; median treatment duration was 48 weeks. Add-on CBD reduced median monthly convulsive seizures by 51% and total seizures by 48% at 12 weeks; reductions were similar through 96 weeks. Proportion of patients with ≥50%, ≥75%, and 100% reductions in convulsive seizures were 52%, 31%, and 11%, respectively, at 12 weeks, with similar rates through 96 weeks. Cannabidiol was generally well tolerated; most common AEs were diarrhea (29%) and somnolence (22%). SIGNIFICANCE Results from this ongoing EAP support previous observational and clinical trial data, showing that add-on CBD may be an efficacious long-term treatment option for TRE. Randomized, Dose-Ranging Safety Trial of Cannabidiol in Dravet Syndrome Devinsky O, Patel AD, Thiele EA, et al; GWPCARE1 Part A Study Group. Neurology. 2018;90(14):e1204-e1211. OBJECTIVE To evaluate the safety and preliminary pharmacokinetics of a pharmaceutical formulation of purified cannabidiol (CBD) in children with Dravet syndrome. METHODS Patients aged 4 to 10 years were randomized 4:1 to CBD (5, 10, or 20 mg/kg/d) or placebo taken twice daily. The double-blind trial comprised 4-week baseline, 3-week treatment (including titration), 10-day taper, and 4-week follow-up periods. Completers could continue in an open-label extension. Multiple pharmacokinetic blood samples were taken on the first day of dosing and at end of treatment for measurement of CBD, its metabolites 6-OH-CBD, 7-OH-CBD, and 7-COOH-CBD, and antiepileptic drugs (AEDs; clobazam and metabolite N-desmethylclobazam [N-CLB], valproate, levetiracetam, topiramate, and stiripentol). Safety assessments were clinical laboratory tests, physical examinations, vital signs, electrocardiograms, adverse events (AEs), seizure frequency, and suicidality. RESULTS Thirty-four patients were randomized (10, 8, and 9 to the 5, 10, and 20 mg/kg/d CBD groups and 7 to placebo); 32 (94%) completed treatment. Exposure to CBD and its metabolites was dose proportional (AUC 0-t ). Cannabidiol did not affect concomitant AED levels, apart from an increase in N-CLB (except in patients taking stiripentol). The most common AEs on CBD were pyrexia, somnolence, decreased appetite, sedation, vomiting, ataxia, and abnormal behavior. Six patients taking CBD and valproate developed elevated transaminases; none met criteria for drug-induced liver injury and all recovered. No other clinically relevant safety signals were observed. CONCLUSIONS Exposure to CBD and its metabolites increased proportionally with dose. An interaction with N-CLB was observed, likely related to CBD inhibition of cytochrome P450 subtype 2C19. Cannabidiol resulted in more AEs than placebo but was generally well tolerated. CLASSIFICATION OF EVIDENCE This study provides class I evidence that for children with Dravet syndrome, CBD resulted in more AEs than placebo but was generally well tolerated.",2019,Add-on CBD reduced median monthly convulsive seizures by 51% and total seizures by 48% at 12 weeks; reductions were similar through 96 weeks.,"['Fourteen patients who received cannabidiol (9%) had elevated liver aminotransferase concentrations', '30 clinical centers, we randomly assigned patients with the Lennox-Gastaut syndrome (age range, 2-55 years) who had had 2 or more drop seizures per week during a 28-day baseline period to receive', 'Twenty-five US-based EAP sites enrolling patients with TRE taking stable doses of antiepileptic drugs (AEDs) at baseline were included', 'EAP patients treated through December 2016', 'Mean age was 13 years (range, 0.4-62', 'patients with severe early-onset epilepsy', 'children with Dravet syndrome', 'A total of 225 patients were enrolled; 76 patients', 'Patients aged 4 to 10 years', 'children and adults with the Lennox-Gastaut syndrome', 'Children and Adults With Treatment-Resistant Epilepsies', 'patients with the Lennox-Gastaut syndrome, a severe developmental epileptic encephalopathy']","['valproate', 'placebo', 'cannabidiol oral solution at a dose of 20 mg/kg of body weight (20-mg cannabidiol group) or 10 mg/kg (10-mg cannabidiol group) or matching placebo', 'CBD', 'purified cannabidiol (CBD', 'conventional antiepileptic medication', 'valproate, levetiracetam, topiramate, and stiripentol', 'oral CBD', 'Cannabidiol']","['convulsive seizures', 'safety and efficacy', 'Median number of concomitant AEDs', 'tolerated', 'somnolence, decreased appetite, and diarrhea', 'concomitant AED levels', 'Multiple pharmacokinetic blood samples', 'CBD were pyrexia, somnolence, decreased appetite, sedation, vomiting, ataxia, and abnormal behavior', 'total seizures', 'clinical laboratory tests, physical examinations, vital signs, electrocardiograms, adverse events (AEs), seizure frequency, and suicidality', 'elevated transaminases', 'frequency of drop seizures', 'efficacy and safety', 'elevated liver aminotransferase concentrations', 'median monthly convulsive and total seizure frequency', 'percentage change from baseline in the frequency of drop seizures', 'diarrhea', 'Adverse events (AEs', 'somnolence', 'median number of drop seizures']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0270846', 'cui_str': 'Atonic Seizures'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444864', 'cui_str': 'AM 13 (qualifier value)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0751122', 'cui_str': 'Myoclonic Epilepsy, Severe, Of Infancy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0543888', 'cui_str': 'Epileptic encephalopathy (disorder)'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0270846', 'cui_str': 'Atonic Seizures'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",14.0,0.546653,Add-on CBD reduced median monthly convulsive seizures by 51% and total seizures by 48% at 12 weeks; reductions were similar through 96 weeks.,"[{'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Perry', 'Affiliation': ''}]",Epilepsy currents,['10.1177/1535759719835671'] 1175,31712981,Root caries lesions inhibition and repair using commercial high-fluoride toothpastes with or without tri-calcium phosphate and conventional toothpastes containing or not 1.5% arginine CaCO 3 : an in situ investigation.,"OBJECTIVES This double-blind, crossover, and in situ study evaluated the effect of commercial high-F toothpastes with or without functionalized β-tri-calcium phosphate (fTCP) and conventional-F toothpaste containing or not 1.5% arginine-CaCO 3 in preventing and repairing root caries-like lesions. METHODS Twelve volunteers wore palatal appliances containing sound (S) and pre-demineralized (PD) bovine root dentin blocks in 4 phases of 14 days/each. They used F toothpastes, 3×/day: (i) 1,450 μg F/g (conventional-F); (ii) 1,450 μg F/g + 1.5% arginine-CaCO 3 (conventional-F + arginine/CaCO 3 ); (iii) 5,000 μg F/g (high-F); and (iv) 5,000 μg F/g (high-F + fTCP). Sucrose solution (20%) was dropped 8×/day on the S blocks. The demineralization in the S blocks and the remineralization in the PD ones were estimated by % of surface hardness difference (%SH-S) and % of SH recovery (%SHR-PD), respectively. Caries lesion area (ΔS) was determined in the blocks. Statistical analyses were performed by one-way ANOVA/Kruskal-Wallis and multiple comparisons tests (p < 0.05). RESULTS Both high-F toothpastes presented similar effect to prevent early caries lesions and it was higher than conventional-F + arginine/CaCO 3. All treatments resulted in significantly lower ΔS values compared with conventional-F toothpaste (p < 0.0001). High-F + fTCP showed non-significantly higher preventive and reversible effect compared to high-F. The effect of conventional-F + arginine/CaCO 3 was similar to high-F and lower than high-F + fTCP in preventing and reverting in-deep caries lesions. CONCLUSIONS Overall, high-F toothpastes seem to be more effective and interesting feasible strategy for both prevention and remineralization actions in root dentin. CLINICAL RELEVANCE With the trend of increasing dentin root caries, this study brings new evidences about the preventive and repair effect of high-F toothpastes with or without fTCP in root caries and support the use of arginine in toothpastes.",2020,Both high-F toothpastes presented similar effect to prevent early caries lesions and it was higher than conventional-F + arginine/CaCO 3. ,"['i) 1,450\xa0μg', 'Twelve volunteers wore', 'iii) 5,000\xa0μg']","['commercial high-F toothpastes with or without functionalized β-tri-calcium phosphate (fTCP) and conventional-F toothpaste containing or not 1.5% arginine-CaCO', 'palatal appliances containing sound (S) and pre-demineralized (PD) bovine root dentin blocks', 'conventional-F toothpaste', 'F toothpastes, 3×/day', 'F/g (conventional-F); (ii) 1,450\xa0μg', 'High-F + fTCP', 'Sucrose solution', 'high-F + fTCP', 'commercial high-fluoride toothpastes with or without tri-calcium phosphate and conventional toothpastes containing or not 1.5% arginine CaCO 3 ', 'F/g\u2009+\u20091.5% arginine-CaCO 3 (conventional-F + arginine/CaCO 3 ']","['early caries lesions', 'dentin root caries', 'SH recovery', 'Caries lesion area (ΔS']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0243112'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0649543', 'cui_str': '4-fluoro-1-(1-(2-thienyl)cyclohexyl)piperidine'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0162644', 'cui_str': 'Root Caries'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",12.0,0.0474595,Both high-F toothpastes presented similar effect to prevent early caries lesions and it was higher than conventional-F + arginine/CaCO 3. ,"[{'ForeName': 'Marilia Mattar', 'Initials': 'MM', 'LastName': 'de Amoêdo Campos Velo', 'Affiliation': 'Department of Operative Dentistry, Endodontics and Dental Materials, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75 Vila Universitária, Bauru, SP, Brazil.'}, {'ForeName': 'Maria Angélica Silvério', 'Initials': 'MAS', 'LastName': 'Agulhari', 'Affiliation': 'Department of Operative Dentistry, Endodontics and Dental Materials, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75 Vila Universitária, Bauru, SP, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75, Bauru, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Magalhães', 'Affiliation': 'Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Al. Dr Octávio Pinheiro Brisolla 9-75, Bauru, SP, Brazil.'}, {'ForeName': 'Heitor Marques', 'Initials': 'HM', 'LastName': 'Honório', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75, Bauru, SP, Brazil.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Operative Dentistry, Endodontics and Dental Materials, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75 Vila Universitária, Bauru, SP, Brazil. wang.linda@usp.br.'}]",Clinical oral investigations,['10.1007/s00784-019-03084-8'] 1176,30936683,"Dexmedetomidine for the prevention of emergence delirium and postoperative behavioral changes in pediatric patients with sevoflurane anesthesia: a double-blind, randomized trial.","Objectives Emergence delirium (ED) is a common neurologic complication that can not only distress children and their families in the early postanesthetic period, but can also have adverse effects on children in the long-term. This study aimed to investigate the effects of single-dose dexmedetomidine on ED in children with sevoflurane anesthesia and to observe postoperative behavioral changes through long-term follow-up. Methods Patients aged 2-7 years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy were randomized to receive dexmedetomidine 0.5 μg/kg (Group D) or volume-matched normal saline (Group C) over 10 minutes after induction of anesthesia. The primary outcome was the incidence of ED within 30 minutes after extubation. Other outcomes were the incidence of pain, extubation time, post-anesthesia care unit (PACU) length of stay after extubation, adverse events, and the incidence of negative postoperative behavioral changes (NPOBCs). Results Ninety children completed the study. Compared with the control group (Group C), dexmedetomidine decreased the incidence of ED (31.1% vs 53.3%; P =0.033) and pain (28.9% vs 57.8%; P =0.006), but it prolonged extubation time ( P ⩽0.001). PACU length of stay after extubation and the percentage of adverse events were similar between groups. The incidence of NPOBCs in Group D was significantly lower at 1 and 7 days after discharge (33.3% vs 60.0%; P =0.011% and 24.4% vs 46.7%; P =0.028, respectively) than it was in Group C, but no significant difference was found at the 30th day. Conclusion Dexmedetomidine 0.5 μg/kg reduced the incidence of ED after sevoflurane anesthesia and might be used to prevent NPOBCs. Clinical trials registration ChiCTR1800016828.",2019,"Compared with the control group (Group C), dexmedetomidine decreased the incidence of ED (31.1% vs 53.3%; P =0.033) and pain (28.9% vs 57.8%; P =0.006), but it prolonged extubation time ( P ⩽0.001).","['Patients aged 2-7 years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy', 'children with sevoflurane anesthesia and to observe postoperative behavioral changes through long-term follow-up', 'Ninety children completed the study', 'pediatric patients with sevoflurane anesthesia']","['dexmedetomidine', 'Dexmedetomidine', 'dexmedetomidine 0.5 μg/kg (Group D) or volume-matched normal saline']","['incidence of NPOBCs', 'prolonged extubation time', 'pain', 'incidence of pain, extubation time, post-anesthesia care unit (PACU) length of stay after extubation, adverse events, and the incidence of negative postoperative behavioral changes (NPOBCs', 'PACU length of stay after extubation and the percentage of adverse events', 'incidence of ED within 30 minutes after extubation', 'incidence of ED']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}]",90.0,0.474378,"Compared with the control group (Group C), dexmedetomidine decreased the incidence of ED (31.1% vs 53.3%; P =0.033) and pain (28.9% vs 57.8%; P =0.006), but it prolonged extubation time ( P ⩽0.001).","[{'ForeName': 'Mengzhu', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Miao', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Tianchu', 'Initials': 'T', 'LastName': 'Gu', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Dongyue', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Jindong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China, liujindong1818@163.com.'}]","Drug design, development and therapy",['10.2147/DDDT.S196075'] 1177,32407239,Effect of histamine-receptor antagonism on leg blood flow during exercise.,"Histamine mediates vasodilation during inflammatory and immune responses, as well as following endurance exercise. During exercise, intramuscular histamine concentration increases, and its production, appears related to exercise intensity and duration. However, whether histamine contributes to exercise hyperemia and promotes exercise blood flow in an intensity- or duration-dependent pattern is unknown. The purpose of this study was to compare leg blood flow across a range of exercise intensities, before and after prolonged exercise, with and without histamine-receptor antagonism. It was hypothesized that combined oral histamine H 1 /H 2 -receptor antagonism would decrease leg blood flow, and the effect would be greater at higher intensities and following prolonged exercise. Sixteen (7F, 9M) volunteers performed single-leg knee-extension exercise after consuming either placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade). Exercise consisted of two graded protocols at 20, 40, 60, and 80% of peak power, separated by 60 min of knee-extension exercise at 60% of peak power. Femoral artery blood flow was measured by ultrasonography. Femoral artery blood flow increased with exercise intensity up to 2,660 ± 97 mL/min at 80% of peak power during Placebo ( P < 0.05). Blood flow was further elevated with Blockade to 2,836 ± 124 mL/min ( P < 0.05) at 80% peak power (9.1 ± 4.8% higher than placebo). These patterns were not affected by prolonged exercise ( P = 0.13). On average, femoral blood flow during prolonged exercise was 12.7 ± 2.8% higher with Blockade vs. Placebo ( P < 0.05). Contrary to the hypothesis, these results suggest that histamine receptor antagonism during exercise, regardless of intensity or duration, increases leg blood flow measured by ultrasonography. NEW & NOTEWORTHY Leg blood flow during exercise was increased by taking antihistamines, which block the receptors for histamine, a molecule often associated with inflammatory and immune responses. The elevated blood flow occurred over exercise intensities ranging from 20 to 80% of peak capacity and during exercise of 60 min duration. These results suggest that exercise-induced elevations in histamine concentrations are involved in novel, poorly understood, and perhaps complex ways in the exercise response.",2020,Blood flow was further elevated with Blockade to 2836±124 ml·min -1 (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,[],"['Placebo', 'single-leg knee-extension exercise after consuming either Placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade', 'histamine-receptor antagonism', 'histamine', 'Histamine']","['leg blood flow', 'Blood flow', 'Femoral artery blood flow', 'femoral blood flow']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0034813', 'cui_str': 'Histamine receptor'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.0688832,Blood flow was further elevated with Blockade to 2836±124 ml·min -1 (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'La Salle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Trinity', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00689.2019'] 1178,30401918,Management and diagnosis of mitochondrial fatty acid oxidation disorders: focus on very-long-chain acyl-CoA dehydrogenase deficiency.,"Mitochondrial fatty acid oxidation disorders (FAODs) are caused by defects in β-oxidation enzymes, including very long-chain acyl-CoA dehydrogenase (VLCAD), trifunctional protein (TFP), carnitine palmitoyltransferase-2 (CPT2), carnitine-acylcarnitine translocase (CACT) and others. During prolonged fasting, infection, or exercise, patients with FAODs present with hypoglycemia, rhabdomyolysis, cardiomyopathy, liver dysfunction, and occasionally sudden death. This article describes the diagnosis, newborn screening, and treatment of long-chain FAODs with a focus on VLCAD deficiency. VLCAD deficiency is generally classified into three phenotypes based on onset time, but the classification should be comprehensively determined based on genotype, residual enzyme activity, and clinical course, due to a lack of apparent genotype-phenotype correlation. With the expansion of newborn screening for FAODs, several issues have arisen, such as missed detection, overdiagnosis (including detection of benign/asymptomatic type), and poor prognosis of the neonatal-onset form. Meanwhile, dietary management and restriction of exercise have been unnecessary for patients with the benign/asymptomatic type of VLCAD deficiency with a high fatty acid oxidation flux score. Although L-carnitine therapy for VLCAD/TFP deficiency has been controversial, supplementation with L-carnitine may be accepted for CPT2/CACT and multiple acyl-CoA dehydrogenase deficiencies. Recently, a double-blind, randomized controlled trial of triheptanoin (seven-carbon fatty acid triglyceride) versus trioctanoin (regular medium-chain triglyceride) was conducted and demonstrated improvement of cardiac functions on triheptanoin. Additionally, although the clinical efficacy of bezafibrate remains controversial, a recent open-label clinical trial showed efficacy of this drug in improving quality of life. These drugs may be promising for the treatment of FAODs, though further studies are required.",2019,"With the expansion of newborn screening for FAODs, several issues have arisen, such as missed detection, overdiagnosis (including detection of benign/asymptomatic type), and poor prognosis of the neonatal-onset form.",['patients with the benign/asymptomatic type of VLCAD deficiency with a high fatty acid oxidation flux score'],"['bezafibrate', 'triheptanoin (seven-carbon fatty acid triglyceride) versus trioctanoin (regular medium-chain triglyceride']",['quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3887523', 'cui_str': 'Acadvl'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0077030', 'cui_str': 'glycerol tricaprylate'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]",[{'cui': 'C0034380'}],,0.025148,"With the expansion of newborn screening for FAODs, several issues have arisen, such as missed detection, overdiagnosis (including detection of benign/asymptomatic type), and poor prognosis of the neonatal-onset form.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Pediatrics, Shimane University Faculty of Medicine, 89-1, Ennya, Izumo, Shimane, 693-8501, Japan. k-yamada@med.shimane-u.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Taketani', 'Affiliation': 'Department of Pediatrics, Shimane University Faculty of Medicine, 89-1, Ennya, Izumo, Shimane, 693-8501, Japan.'}]",Journal of human genetics,['10.1038/s10038-018-0527-7'] 1179,31887280,Comparison of Perioperative Parameters in Femtosecond Laser-Assisted Cataract Surgery Using 3 Nuclear Fragmentation Patterns.,"PURPOSE The purpose of this study was to compare the perioperative parameters of quadrant, sextant, and grid lens fragmentation patterns in femtosecond laser-assisted cataract surgery (FLACS). DESIGN Prospective randomized clinical trial. METHODS Setting: Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. STUDY POPULATION A total of 894 eyes in 661 patients with cataracts were enrolled. Intervention or observation procedures: the nuclear density was graded according to the Emery-Little classification. Patients received lens fragmentation using a quadrant, sextant, or grid pattern after random allocation. Evaluations included intraoperative parameters, complications, and postoperative outcomes. MAIN OUTCOME MEASUREMENTS effective phacoemulsification time (EPT), intraoperative complications, visual acuity and intraocular pressure at one day postoperatively, as well as endothelial cell density, endothelial cell loss, and central corneal thickness at 1 week postoperatively. RESULTS In grade 1 nuclei, the mean EPT in the grid group was the shortest compared to those in the quadrant (P = 0.011) and sextant (P = 0.001) groups. In grade 2 nuclei, all 3 patterns showed no significant differences in the mean EPT (P > 0.05). In grade 3 nuclei, the sextant group revealed shorter mean EPT than the grid (P = 0.017) and quadrant (P > 0.05) groups. In grades 4 and 5 nuclei, the quadrant pattern had the shortest mean EPT among all 3 patterns (P < 0.05). The grid pattern is associated with higher intraocular pressure in hard nuclei (grades 4 and 5) than the other 2 patterns (P < 0.05). CONCLUSIONS The grid and quadrant patterns allow for shorter EPT in soft (grade 1) and hard (grades 4 and 5) nuclei, respectively. All 3 patterns can be selected for treating grade 2 nuclei. The sextant pattern may be the best option when treating grade 3 nuclei. The grid pattern should be avoided in hard nuclei combined with glaucoma or glaucoma suspect.",2020,"In grade 2 nuclei, all three patterns showed no significant difference in the mean EPT (p > 0.05).","['A total of 894 eyes in 661 patients with cataracts were enrolled', 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China']","['femtosecond laser-assisted cataract surgery (FLACS', 'Femtosecond Laser-assisted Cataract Surgery']","['mean EPT', 'nuclear density', 'endothelial cell density (ECD), endothelial cell loss (ECL) and central corneal thickness (CCT', 'intraoperative parameters, complications, and postoperative outcomes', 'Effective phacoemulsification time (EPT), intraoperative complications, visual acuity and intraocular pressure (IOP', 'shorter mean EPT']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",661.0,0.031457,"In grade 2 nuclei, all three patterns showed no significant difference in the mean EPT (p > 0.05).","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Lyu', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Zeren', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China; Department of Plastic Surgery, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Ni', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China. Electronic address: xlren@zju.edu.cn.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.017'] 1180,31837201,Effectiveness of a self-management retraining program improving the quality of life of people receiving continuous ambulatory peritoneal dialysis.,"People receiving continuous ambulatory peritoneal dialysis (CAPD) are often faced with technical difficulties while performing self-dialysis, which can compromise outcomes and health-related quality of life. This mixed-methods exploratory sequential study aims to implement a repeated-measures experimental design to assess the effectiveness of a self-management retraining program. The sample consisted of 41 participants living with chronic kidney disease aged 20 to 80 years who were receiving CAPD. Participants were purposively selected and randomized into experimental and control groups. The experimental group received the self-management retraining program. The control group received standard care. We compared health-related quality of life, self-management behavior, and perceived self-management self-efficacy levels at baseline and 3 and 6 months after enrollment. Participants demonstrated statistically significant increases in self-management behavior (medical adherence) and mental health status. Perceived self-efficacy in self-management was improved; however, this change did not reach statistical significance. We conclude that an self-management retraining program can improve self-management, self-efficacy behaviors, and health-related quality of life in persons receiving CAPD.",2020,"Perceived self-efficacy in self-management was improved; however, this change did not reach statistical significance.","['41 participants living with chronic kidney disease aged 20 to 80\u2009years who were receiving CAPD', 'people receiving continuous ambulatory peritoneal dialysis', 'persons receiving CAPD']","['People receiving continuous ambulatory peritoneal dialysis (CAPD', 'self-management retraining program', 'standard care']","['Perceived self-efficacy', 'quality of life', 'health-related quality of life, self-management behavior, and perceived self-management self-efficacy levels', 'self-management, self-efficacy behaviors, and health-related quality of life', 'self-management behavior (medical adherence) and mental health status']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031140', 'cui_str': 'CAPD'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0031140', 'cui_str': 'CAPD'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",41.0,0.0308888,"Perceived self-efficacy in self-management was improved; however, this change did not reach statistical significance.","[{'ForeName': 'Wanicha', 'Initials': 'W', 'LastName': 'Pungchompoo', 'Affiliation': 'Department of Medical Nursing, Faculty of Nursing, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Saowaros', 'Initials': 'S', 'LastName': 'Parinyajittha', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sirirat', 'Initials': 'S', 'LastName': 'Pungchompoo', 'Affiliation': 'Department of Chemical Engineering, Faculty of Engineer, Rajamangala University of Technology Srivijaya, Songkhla, Thailand.'}, {'ForeName': 'Paweena', 'Initials': 'P', 'LastName': 'Kumtan', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Nursing & health sciences,['10.1111/nhs.12672'] 1181,30900195,A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial.,"Parents of children with Autism experience high levels of stress. Resiliency is the ability to cope and adapt when faced with stressful events. This randomized, waitlist controlled pilot trial examines the feasibility, acceptability, and preliminary efficacy of an adapted virtual mind-body group intervention for parents of children with ASD. The intervention was feasible and acceptable. The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively). Findings showed promising feasibility, acceptability, and preliminary efficacy for parents of children with ASD.",2020,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","['parents of children with ASD', 'Parents of children with Autism experience high levels of stress', 'Parents of Children with Autism']","['adapted virtual mind-body group intervention', 'Virtual Resiliency Intervention']","['resiliency and stress reactivity/coping relative', 'distress']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0497679,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Kuhlthau', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA. kkuhlthau@mgh.harvard.edu.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Lindly', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chad-Friedman', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Proszynski', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03976-4'] 1182,31383366,Insulin Glargine U100 Improved Glycemic Control and Reduced Nocturnal Hypoglycemia in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease Stages 3 and 4.,"PURPOSE Glycemic control in patients with chronic kidney disease (CKD) is particularly hard to achieve because of a slower insulin degradation by the kidney. It might modify the long-acting insulin analogue pharmacokinetics, increasing its time-action and the risk of hypoglycemia. However, because this insulin has no peak action, it might be a more tolerable approach to patients with CKD. This hypothesis remains to be tested, because no study has thus far examined the efficacy and safety profile of long-acting basal analogues in patients with significant loss of renal function. The purpose of this study was to compare the glycemic response to treatment with glargine U100 or neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus (T2DM) and CKD stages 3 and 4. METHODS Thirty-four patients were randomly assigned to glargine U100 or NPH insulin after a 2-way crossover open-label design. The primary end point was the difference in glycosylated hemoglobin (HbA 1c ) and in the number of hypoglycemic events between weeks 1 and 24, whereas secondary end points included changes in glycemic patterns, weight and body mass index, and total daily dose of insulin. HbA 1c was determined by ion-exchange HPLC, and hypoglycemia was defined as glucose concentration of 54 mg/dL (3.0 mmol/L) detected by self-monitoring of plasma glucose or continuous glucose monitoring. FINDINGS After 24 weeks, mean HbA 1c decreased on glargine U100 treatment (-0.91%; P < 0.001), but this benefit was not observed for NPH (0.23%; P = 0.93). Moreover, incidence of nocturnal hypoglycemia was 3 times lower with glargine than with NPH insulin (P = 0.047). IMPLICATIONS Our results found that insulin glargine U100 could be effective, once it improved glycemic control, reducing HbA 1c with fewer nocturnal hypoglycemia episodes compared with NPH insulin in this population. These clinical benefits justify the use of basal insulin analogues, despite their high cost to treat patients with T2DM and CKD stages 3 and 4. Clinical Trials identifier: NCT02451917.",2019,"After 24 weeks, mean HbA 1c decreased on glargine U100 treatment (-0.91%; P < 0.001), but this benefit was not observed for NPH (0.23%; P = 0.93).","['patients with CKD', 'patients with type 2 diabetes mellitus (T2DM) and CKD stages 3 and 4', 'Thirty-four patients', 'patients with significant loss of renal function', 'patients with chronic kidney disease (CKD', 'Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease Stages 3 and 4']","['Insulin Glargine', 'glargine', 'glargine U100 or neutral protamine Hagedorn (NPH) insulin', 'glargine U100 or NPH insulin', 'insulin glargine']","['mean HbA 1c decreased on glargine U100 treatment', 'glycemic response', 'glycemic patterns, weight and body mass index, and total daily dose of insulin', 'glycosylated hemoglobin (HbA 1c ) and in the number of hypoglycemic events', 'Nocturnal Hypoglycemia', 'incidence of nocturnal hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",34.0,0.0142166,"After 24 weeks, mean HbA 1c decreased on glargine U100 treatment (-0.91%; P < 0.001), but this benefit was not observed for NPH (0.23%; P = 0.93).","[{'ForeName': 'Carolina C', 'Initials': 'CC', 'LastName': 'Betônico', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Silvia Maria O', 'Initials': 'SMO', 'LastName': 'Titan', 'Affiliation': 'Nephrology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Aécio', 'Initials': 'A', 'LastName': 'Lira', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tatiana S', 'Initials': 'TS', 'LastName': 'Pelaes', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Lúcia C', 'Initials': 'MLC', 'LastName': 'Correa-Giannella', 'Affiliation': 'Laboratory of Carbohydrates and Radioimmunoassays (LIM-18), Discipline of Endocrinology and Metabolism, Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Nery', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Queiroz', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil. Electronic address: marciasqz@gmail.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.011'] 1183,30818406,Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial.,"OBJECTIVE To evaluate whether real-time continuous glucose monitoring improves glycemic control over intermittent self-monitoring of blood glucose in gestational diabetes. STUDY DESIGN We performed a single-institution randomized controlled trial. Patients with gestational diabetes were randomized to use either real-time or blinded continuous glucose monitoring. The primary outcome was mean sensor glucose level during the fourth week of continuous glucose monitoring use. Secondary outcomes included glycemic control and a composite of obstetric and neonatal outcomes. RESULTS Of the 40 enrolled patients, 12 (60%) patients in the blinded continuous glucose monitoring group and 11 (55%) in the real-time continuous glucose monitoring group completed 4 weeks of monitoring and were included in the final analysis. There was no significant difference in mean sensor glucose level between the blinded continuous glucose monitoring group (98.9 ± 8.9 mg/dL) and the real-time continuous glucose monitoring group (107.5 ± 11.4 mg/dL). There were also no significant differences in the time spent in glycemic target, maternal, or neonatal outcomes. CONCLUSION Our study shows that the use of continuous glucose monitoring with real-time feedback did not significantly decrease mean glucose values compared with intermittent self-monitoring of blood glucose after 4 weeks of continuous glucose monitoring use.",2019,Our study shows that the use of continuous glucose monitoring with real-time feedback did not significantly decrease mean glucose values compared with intermittent self-monitoring of blood glucose after 4 weeks of continuous glucose monitoring use.,"['Gestational Diabetes', '40 enrolled patients, 12 (60%) patients', 'Patients with gestational diabetes', 'gestational diabetes']","['real-time continuous glucose monitoring', 'Real-Time Continuous Glucose Monitoring', 'real-time or blinded continuous glucose monitoring']","['mean glucose values', 'time spent in glycemic target, maternal, or neonatal outcomes', 'glycemic control and a composite of obstetric and neonatal outcomes', 'mean sensor glucose level']","[{'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",40.0,0.051507,Our study shows that the use of continuous glucose monitoring with real-time feedback did not significantly decrease mean glucose values compared with intermittent self-monitoring of blood glucose after 4 weeks of continuous glucose monitoring use.,"[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Lane', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia.'}, {'ForeName': 'Malgorzata A', 'Initials': 'MA', 'LastName': 'Mlynarczyk', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'de Veciana', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Green', 'Affiliation': 'Healthcare Analytics and Delivery Science Institute, Eastern Virginia Medical School, Norfolk, Virginia.'}, {'ForeName': 'Dana I', 'Initials': 'DI', 'LastName': 'Baraki', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, Virginia.'}, {'ForeName': 'Alfred Z', 'Initials': 'AZ', 'LastName': 'Abuhamad', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia.'}]",American journal of perinatology,['10.1055/s-0039-1678733'] 1184,31472414,Does pectoralis minor stretching provide additional benefit over an exercise program in participants with subacromial pain syndrome? A randomized controlled trial.,"BACKGROUND Adaptive shortening of the pectoralis minor is one of the biomechanical mechanisms associated with subacromial pain syndrome (SPS). OBJECTIVE To compare the effects of an exercise program alone with an exercise program in combination with pectoralis minor stretching in participants with SPS. DESIGN Randomized controlled trial. METHODS Eighty adult participants with SPS were randomly allocated to two groups. The control group (n = 40) received a 12-week specific exercise program and the intervention group (n = 40) received the same program plus stretching exercises of the pectoralis minor muscle. The primary outcome measure was shoulder function assessed by a Constant-Murley questionnaire, and the secondary outcomes were the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, visual analog scale (VAS), and pectoralis minor resting length. RESULTS The present study shows no difference between the two interventions according to the Constant-Murley questionnaire (1.5 points; p = 0.58), VAS at rest (0.2 cm; p = 0.11), VAS at movement (0.5 cm; p = 0.08), and pectoralis minor resting length (0.3 cm; p = 0.06). The DASH questionnaire showed greater functional improvement in the control group (5.4 points; p = 0.02). Finally, only pectoralis minor length index showed difference statistical significant in favor of intervention group (0.3%; p = 0.04). CONCLUSION In the short-term, the addition of a program of stretching exercises of the pectoralis minor does not provide significant clinical benefit with respect to functional improvement or pain reduction in participants with SPS. TRIAL REGISTRATION Brazilian registry of clinical trials UTN number U1111-1210-3555. Registered 5 March 2018.",2019,The DASH questionnaire showed greater functional improvement in the control group (5.4 points; p = 0.02).,"['Eighty adult participants with SPS', 'participants with SPS', 'participants with subacromial pain syndrome']","['exercise program', 'specific exercise program and the intervention group (n\u202f=\u202f40) received the same program plus stretching exercises of the pectoralis minor muscle', 'exercise program alone with an exercise program']","['Constant-Murley questionnaire', 'shoulder function assessed by a Constant-Murley questionnaire, and the secondary outcomes were the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, visual analog scale (VAS), and pectoralis minor resting length', 'functional improvement', 'pain reduction']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",80.0,0.14676,The DASH questionnaire showed greater functional improvement in the control group (5.4 points; p = 0.02).,"[{'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Gutiérrez-Espinoza', 'Affiliation': 'Faculty of Health, Universidad de las Américas, Santiago, Chile; Physical Therapy Department, Clinical Hospital San Borja Arriarán, Santiago, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Araya-Quintanilla', 'Affiliation': 'Faculty of Health, Universidad de las Américas, Santiago, Chile; Faculty of Health, Universidad SEK, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gutiérrez-Monclus', 'Affiliation': 'Orthopedic Surgeon, Instituto Traumatológico, Santiago, Chile.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ríos-Riquelme', 'Affiliation': 'Department Sciences in Physical Activity, Universidad de Santiago, Santiago, Chile.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Álvarez-Bueno', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain; Universidad Politécnica y Artística del Paraguay, Asunción, Paraguay. Electronic address: celia.alvarezbueno@uclm.es.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martínez-Vizcaino', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain; Facultad de Ciencias de la Salud, Universidad Autónoma de Chile, Talca, Chile.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Cavero-Redondo', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain; Universidad Politécnica y Artística del Paraguay, Asunción, Paraguay.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2019.102052'] 1185,31131679,A Randomized Study of Passive versus Active PrEP Patient Navigation for a Heterogeneous Population at Risk for HIV in South Florida.,"Effective approaches to promoting pre-exposure prophylaxis (PrEP) and linkage to PrEP care among those who may benefit the most from PrEP has proven to be a major challenge. We designed and pilot tested a strengths-based case management (SBCM) intervention for PrEP linkage. Adults interested in PrEP and meeting criteria (n = 61) were randomized to passive referral (control) or active SBCM (treatment). Outcomes measured were completion of provider visit, initiation of PrEP, and time to initiation of PrEP. Overall, 34% initiated PrEP by 12 weeks: 9 (29%) in the control group and 12 (40%) in the treatment group. The mean time to PrEP initiation was 13.1 weeks (95% confidence interval, 12.0-14.2) with no difference between groups ( P = .382). There was a 21% difference in achieving a provider visit between the treatment and control groups (53.3% versus 32.3%) by 12 weeks ( P = .096). Participants encountered financial, logistical, social, and provider-related barriers to PrEP access. Strengths-based case management-based patient navigation is a promising strategy for assisting PrEP seekers in obtaining a medical provider visit and initiating PrEP.",2019,Strengths-based case management-based patient navigation is a promising strategy for assisting PrEP seekers in obtaining a medical provider visit and initiating PrEP.,"['Heterogeneous Population at Risk for HIV in South Florida', 'Adults interested in PrEP and meeting criteria (n = 61']","['Strengths-based case management-based patient navigation', 'passive referral (control) or active SBCM (treatment', 'strengths-based case management (SBCM) intervention', 'Passive versus Active PrEP Patient Navigation']","['mean time to PrEP initiation', 'achieving a provider visit', 'completion of provider visit, initiation of PrEP, and time to initiation of PrEP']","[{'cui': 'C0242444', 'cui_str': 'Population at Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",61.0,0.08251,Strengths-based case management-based patient navigation is a promising strategy for assisting PrEP seekers in obtaining a medical provider visit and initiating PrEP.,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Doblecki-Lewis', 'Affiliation': '1 Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Stefani', 'Initials': 'S', 'LastName': 'Butts', 'Affiliation': '1 Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Botero', 'Affiliation': '1 Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Klose', 'Affiliation': '1 Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cardenas', 'Affiliation': '2 Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Feaster', 'Affiliation': '2 Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Journal of the International Association of Providers of AIDS Care,['10.1177/2325958219848848'] 1186,30860654,The effect of a hemodialysis patient education program on fluid control and dietary compliance.,"INTRODUCTION Some hemodialysis patients may experience problems in completing activities of daily living and adhering to diet and fluid restrictions due to a decrease in self-care power and a loss of competence. METHODS The study was conducted with 78 people assigned to the intervention (N = 38) and control groups (N = 40). Data were collected using the sociodemographic characteristics questionnaire, dialysis diet and fluid nonadherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS). The participants in the intervention group were given the ""Nutrition Education Booklet for Dialysis Patients"". The participants in the intervention group were trained through four education sessions across 4 months, and the measurement tools were administered to them. The participants in the control group were interviewed twice, once at the onset of the study and once 2 months later and the measurement tools were administered to them. FINDINGS In the intervention group, a decrease was observed in the pre- and postdialysis interdialytic weight gain, ultrafiltration (UF) volume, and blood pressure values of the patients after the training. There was a statistically significant decrease in the mean scores for the frequency and degree of nonadherence to diet restriction, and for the frequency and degree of nonadherence to fluid restriction in the participants in the intervention group compared to the participants in the control group (P < 0.05). There was a statistically significant increase in the mean scores obtained from the FCHPS and its subscales by the participants in the intervention group compared to the participants in the control group (P < 0.05). CONCLUSION The training given to the hemodialysis patients positively contributed to their adherence to diet and fluid restrictions. The patients' adherence to diet and fluid restriction increased.",2019,"There was a statistically significant decrease in the mean scores for the frequency and degree of nonadherence to diet restriction, and for the frequency and degree of nonadherence to fluid restriction in the participants in the intervention group compared to the participants in the control group (P < 0.05).",['78 people assigned to the intervention (N = 38) and control groups (N = 40'],"['hemodialysis patient education program', 'Nutrition Education Booklet']","['fluid control and dietary compliance', 'pre- and postdialysis interdialytic weight gain, ultrafiltration (UF) volume, and blood pressure values', 'mean scores', 'sociodemographic characteristics questionnaire, dialysis diet and fluid nonadherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS', 'mean scores for the frequency and degree of nonadherence to diet restriction', 'frequency and degree of nonadherence to fluid restriction']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0336604', 'cui_str': 'Patient scale, device (physical object)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}]",78.0,0.0209364,"There was a statistically significant decrease in the mean scores for the frequency and degree of nonadherence to diet restriction, and for the frequency and degree of nonadherence to fluid restriction in the participants in the intervention group compared to the participants in the control group (P < 0.05).","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Başer', 'Affiliation': 'Internal Medicine Nursing, Department of Nursing, Faculty of Health Science, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Mukadder', 'Initials': 'M', 'LastName': 'Mollaoğlu', 'Affiliation': 'Internal Medicine Nursing, Department of Nursing, Faculty of Health Science, Sivas Cumhuriyet University, Sivas, Turkey.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12744'] 1187,30784924,"The effect of Xinkeshu tablets on depression and anxiety symptoms in patients with coronary artery disease: Results from a double-blind, randomized, placebo-controlled study.","A large proportion of patients with coronary artery disease (CAD) suffer from depression or anxiety symptoms and this is associated with increased mortality [1]. This double-blinded, randomized, placebo-controlled, clinical trial (ChiCTR-IPR-17010940) aimed to explore whether Xinkeshu tablets can reduce anxiety or depressive symptoms in CAD patients and how this is related to the concentration of plasma cytokines. Sixty patients with CAD anda Hospital Anxiety and Depression Scale (HADS-a/HADS-d) score of ≥8 were treated with Xinkeshu tablets or placebo for 12 weeks following percutaneous revascularization. Depressive/anxiety symptoms and the levels of 440 peripheral blood cytokines were evaluated at baseline and after 12 weeks treatment. Results showed significantly lower (P < 0.05) HADS-a/HADS-d and PHQ-9 scores in CAD patients treated with Xinkeshu tablets than in those who received placebo. These improvements were associated with changes in certain peripheral blood cytokines; most notably trappin-2, adiponectin, interleukin 1β (IL-1β), thrombopoietin, activated leukocyte cell adhesion molecule (ALCAM), neurotrophin-3 (NT-3), and transferrin. A significant correlation between anxiety/depression symptoms and trappin-2, NT-3, transferrin, and ALCAM (p < 0.05) were observed in an independent cohort of patients with CAD. These findings were in-keeping with the anti-depressive effects of Xinkeshu tablets. This trial demonstrates that Xinkeshu tablets can improve anxiety and depression symtoms effectively address in patients with coronary heart disease possibly through increasing the blood ratio of anti-inflammatory:pro-inflammatory cytokines.",2019,Results showed significantly lower (P < 0.05) HADS-a/HADS-d and PHQ-9 scores in CAD patients treated with Xinkeshu tablets than in those who received placebo.,"['CAD patients', 'patients with coronary artery disease (CAD', 'patients with coronary heart disease', 'patients with coronary artery disease', 'Sixty patients with CAD anda Hospital Anxiety and Depression Scale (HADS-a/HADS-d) score of ≥8 were treated with']","['Xinkeshu tablets', 'Xinkeshu tablets or placebo', 'placebo']","['certain peripheral blood cytokines; most notably trappin-2, adiponectin, interleukin 1β (IL-1β), thrombopoietin, activated leukocyte cell adhesion molecule (ALCAM), neurotrophin-3 (NT-3), and transferrin', 'anxiety/depression symptoms and trappin-2, NT-3, transferrin, and ALCAM', 'anxiety or depressive symptoms', 'depression and anxiety symptoms', 'Depressive/anxiety symptoms and the levels of 440 peripheral blood cytokines', 'HADS-a/HADS-d and PHQ-9 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2934627', 'cui_str': 'xinkeshu'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}, {'cui': 'C0295967', 'cui_str': 'CD166 Antigens'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.393623,Results showed significantly lower (P < 0.05) HADS-a/HADS-d and PHQ-9 scores in CAD patients treated with Xinkeshu tablets than in those who received placebo.,"[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong, China; Shantou University Medical College, Shantou, Guangdong, China.""}, {'ForeName': 'YunLian', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ""Department of Statistics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Daozheng', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Intensive Care Unit of Guangdong Geriatric Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'The Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'The Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'The Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. Electronic address: Minzhouzhang@aliyun.com.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2019.108639'] 1188,30862274,The Comparative Effects of Upper Thoracic Spine Thrust Manipulation Techniques in Individuals With Subacromial Pain Syndrome: A Randomized Clinical Trial.,"BACKGROUND Subacromial pain syndrome (SPS) accounts for as much as 44% of shoulder pain encountered by physical therapists. Thoracic spine thrust manipulation (TSTM) is effective in the short term for improving pain and function in individuals with SPS, but its mechanisms remain elusive. Furthermore, it is unknown whether individuals with SPS respond differently based on the TSTM technique received. OBJECTIVES To compare the immediate effects of a supine TSTM, seated TSTM, and sham manipulation on the primary outcomes of self-reported pain, function, and satisfaction and secondary biomechanical impairments examined in individuals with SPS. METHODS Participants in this randomized clinical trial were randomized to receive a seated TSTM (n = 20), supine TSTM (n = 20), or sham manipulation (n = 20). The primary outcomes of self-reported pain, function, and satisfaction were measured via the Penn Shoulder Score. Secondary outcomes were changes in scapular upward rotation and posterior tilt; peak force generated in tests for the middle trapezius, lower trapezius, and serratus anterior; and pectoralis minor muscle length. Impairment measures were immediately reassessed, and the Penn Shoulder Score was reassessed after 48 hours. RESULTS There were no significant between-group differences in immediate or short-term follow-up outcomes. CONCLUSION Two TSTM techniques resulted in no differences in pain, satisfaction, and function when compared to a sham manipulation. Thoracic spine thrust manipulation did not have an immediate effect on the scapular impairments examined. LEVEL OF EVIDENCE Therapy, level 1. J Orthop Sports Phys Ther 2019;49(10):716-724. Epub 12 Mar 2019. doi:10.2519/jospt.2019.8484 .",2019,"Secondary outcomes were changes in scapular upward rotation and posterior tilt, peak force generated in tests for the middle trapezius, lower trapezius, and serratus anterior, and pectoralis minor muscle length.","['Individuals With Subacromial Pain Syndrome', 'individuals with SPS', 'Subjects']","['sham manipulation', 'supine TSTM, seated TSTM, and sham manipulation', 'seated TSTM', 'supine TSTM', 'Upper Thoracic Spine Thrust Manipulation Techniques', 'Thoracic spine thrust manipulation (TSTM', 'TSTM']","['immediate or short-term follow-up outcomes', 'changes in scapular upward rotation and posterior tilt, peak force generated in tests for the middle trapezius, lower trapezius, and serratus anterior, and pectoralis minor muscle length', 'pain, function, and satisfaction', 'pain, satisfaction and function', 'self-reported pain, function, and satisfaction were measured through the Penn Shoulder Score']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4255078', 'cui_str': 'SPS'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure (body structure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.23532,"Secondary outcomes were changes in scapular upward rotation and posterior tilt, peak force generated in tests for the middle trapezius, lower trapezius, and serratus anterior, and pectoralis minor muscle length.","[{'ForeName': 'Jason K', 'Initials': 'JK', 'LastName': 'Grimes', 'Affiliation': ''}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Puentedura', 'Affiliation': ''}, {'ForeName': 'M Samuel', 'Initials': 'MS', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Amee L', 'Initials': 'AL', 'LastName': 'Seitz', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8484'] 1189,28939629,"Successful reduction of overexposure in patients with rheumatoid arthritis with high serum adalimumab concentrations: an open-label, non-inferiority, randomised clinical trial.","OBJECTIVE High adalimumab serum concentrations do not result in better response in patients with rheumatoid arthritis (RA), suggesting overexposure. We investigated whether patients with adalimumab concentrations >8 µg/mL can prolong their dosing interval by 50% without a clinically relevant change in disease activity. METHODS Consecutive patients with RA, treated with adalimumab 40 mg every other week for at least 28 weeks, were approached for this randomised, open-label, non-inferiority trial. Patients with adalimumab trough concentrations >8 µg/mL were randomly (1:1) assigned to dose-interval prolongation of once every 3 weeks or continuation of every other week. Primary outcome was the change in disease activity score of 28 joints (ΔDAS28-ESR) after 28 weeks, with a non-inferiority margin of 0.6 points. RESULTS In total, 147 patients were screened. Fifty-five patients had concentrations >8 µg/mL and were randomised. Mean ΔDAS28 after 28 weeks was -0.14±SD 0.61 in the prolongation group and 0.30±0.52 in the continuation group. Mean difference was significantly in favour of the prolongation group: 0.44 (95% CI 0.12 to 0.76, p=0.01). CONCLUSIONS Adalimumab-treated patients with RA with trough concentrations >8 µg/mL can prolong their standard dosing interval to once every 3 weeks without loss of disease control. TRIAL REGISTRATION NUMBER NTR3509; Results.",2018,Mean ΔDAS28 after 28 weeks was -0.14±SD 0.61 in the prolongation group and 0.30±0.52 in the continuation group.,"['Patients with adalimumab trough concentrations >8\u2009µg/mL', '40\u2009mg every other week for at least 28 weeks', 'patients with rheumatoid arthritis with high serum adalimumab concentrations', 'Fifty-five patients had concentrations >8\u2009µg/mL and were randomised', 'Consecutive patients with RA, treated with', 'patients with rheumatoid arthritis (RA', '147 patients were screened']","['adalimumab', 'overexposure']","['Mean ΔDAS28', 'change in disease activity score of 28 joints (ΔDAS28-ESR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]",147.0,0.298615,Mean ΔDAS28 after 28 weeks was -0.14±SD 0.61 in the prolongation group and 0.30±0.52 in the continuation group.,"[{'ForeName': 'Merel J', 'Initials': 'MJ', 'LastName': ""l'Ami"", 'Affiliation': 'Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Amsterdam, Netherlands.'}, {'ForeName': 'Charlotte Lm', 'Initials': 'CL', 'LastName': 'Krieckaert', 'Affiliation': 'Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Amsterdam, Netherlands.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Nurmohamed', 'Affiliation': 'Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Amsterdam, Netherlands.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Amsterdam, Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Rispens', 'Affiliation': 'Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam, Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': 'Rheumatology, Amsterdam Rheumatology and Immunology Center, Location VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Gerrit Jan', 'Initials': 'GJ', 'LastName': 'Wolbink', 'Affiliation': 'Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Amsterdam, Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2017-211781'] 1190,30837190,Endoscopic cartilage tympanoplasty: full thickness and partial thickness tragal graft.,"INTRODUCTION Cartilage is the grafting material of choice for certain disorders of the middle ear. The indications for its routine use remain controversial due to the possible detrimental effect on post-operative hearing. OBJECTIVE The present study was carried out to report a personal experience with ""tragal cartilage shield"" tympanoplasty to compare the results, in terms of graft uptake and hearing improvement, of endoscopic cartilage shield technique using either partial thickness or full thickness tragal cartilage for type 1 tympanoplasty and to highlight the tips for single-handed endoscopic ear surgery. METHODS Fifty patients with safe chronic suppurative otitis media, assisted at out-patient department from February 2014 to September 2015 were selected. They were randomly allocated into two groups, 25 patients were included in group A where a full thickness tragal cartilage was used and 25 patients included in group B where a partial thickness tragal cartilage was used. Audiometry was performed 2 months after the surgery in all cases and the patients were followed for one year. RESULTS Out of the total of 50 patients 39 (78%) had a successful graft take up, amongst these 22 belonged to group A and 17 belonged to the group B. The hearing improvement was similar in both groups. CONCLUSION This study reveals that endoscopic tragal cartilage shield tympanoplasty is a reliable technique; with a high degree of graft take and good hearing results, irrespective of the thickness. Furthermore, the tragal cartilage is easily accessible, adaptable, resistant to resorption and single-handed endoscopic ear surgery is minimally invasive, sutureless and provides a panoramic view of the middle ear.",2020,"The hearing improvement in both the groups was very similar. ","['report personal experience with ""tragal cartilage shield"" tympanoplasty', 'Fifty patients with safe chronic suppurative otitis media, presenting in our out-patient department from February 2014 to September 2015 were selected']",['Endoscopic cartilage tympanoplasty'],"['successful graft take', 'hearing improvement']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0018767', 'cui_str': 'Audition'}]",50.0,0.0221733,"The hearing improvement in both the groups was very similar. ","[{'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Parelkar', 'Affiliation': 'Grant Government Medical College & Sir J.J. Hospitals, Mumbai, India. Electronic address: kartikparelkar@gmail.com.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Thorawade', 'Affiliation': 'Grant Government Medical College & Sir J.J. Hospitals, Mumbai, India.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Marfatia', 'Affiliation': 'K.E.M. Hospital, Department of ENT, Parel, Mumbai, India.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Shere', 'Affiliation': 'Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Kalwa, Thane, India.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2018.12.006'] 1191,30840141,Endothelial cell density and corneal graft thickness following excimer laser vs. femtosecond laser-assisted penetrating keratoplasty-a prospective randomized study.,"PURPOSE The study aims to compare the impact of non-mechanical excimer laser-assisted (EXCIMER) and femtosecond laser-assisted (FEMTO) trephinations on graft endothelial cell density (ECD) and graft thickness before and after suture removal following penetrating keratoplasty (PK). METHODS The inclusion criteria for this prospective, randomized, clinical study were as follows: (1) surgeries performed by one surgeon; (2) primary central PK; (3) keratoconus (KC) or Fuchs' dystrophy (FUCHS); (4) no previous intraocular surgery; (5) graft oversize, 0.1 mm; and (6) 16-bite double-running suture. In 68 eyes of 68 patients (mean age: 53.3 ± 19.8 years), PK was performed using either 193-nm MEL70 excimer laser (""EXCIMER"": 17 KC, 18 FUCHS) or 60-KHz femtosecond laser (""FEMTO"": 17 KC, 16 FUCHS) trephination. Specular microscopy (EM 3000) and pachymetry (EM 3000; Pentacam HR; Casia SS-1000) were performed before removing the first suture (11.4 ± 1.9 months) and after removing the second suture (22.6 ± 3.8 months), but before any additional ophthalmic surgery. RESULTS ECD did not differ significantly (P ≥ 0.436) between EXCIMER and FEMTO either with ""all-sutures-in"" (1887 ± 409 vs. 1886 ± 438) or with ""all-sutures-out"" (1703 ± 379 vs. 1737 ± 362). Central corneal thickness and corneal thickness at the thinnest point of the cornea did not differ significantly between EXCIMER and FEMTO either with all-sutures-in (P ≥ 0.096 and P ≥ 0.653) or with all-sutures-out (P ≥ 0.636 and P ≥ 0.717). CONCLUSIONS EXCIMER and FEMTO trephinations from the epithelial side seem to have no disadvantages regarding endothelial cell loss after PK, and both surgical procedures are safe for the endothelium. A larger sample size and longer follow-up are needed to evaluate the long-term impact of EXCIMER and FEMTO trephinations on ECD.",2019,"RESULTS ECD did not differ significantly (P ≥ 0.436) between EXCIMER and FEMTO either with ""all-sutures-in"" (1887 ± 409 vs. 1886 ± 438) or with ""all-sutures-out"" (1703 ± 379 vs. 1737 ± 362).","['68 eyes of 68 patients (mean age: 53.3\u2009±\u200919.8\xa0years', 'penetrating keratoplasty (PK']","['193-nm MEL70 excimer laser (""EXCIMER"": 17 KC, 18 FUCHS) or 60-KHz femtosecond laser', 'mechanical excimer laser-assisted (EXCIMER) and femtosecond laser-assisted (FEMTO) trephinations', ""primary central PK; (3) keratoconus (KC) or Fuchs' dystrophy (FUCHS); (4) no previous intraocular surgery; (5) graft oversize, 0.1\xa0mm; and (6) 16-bite double-running suture"", 'excimer laser vs. femtosecond laser-assisted penetrating keratoplasty']","['graft endothelial cell density (ECD) and graft thickness', 'Central corneal thickness and corneal thickness', 'Endothelial cell density and corneal graft thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022592', 'cui_str': 'Keratoplasty, Penetrating'}]","[{'cui': 'C0392265', 'cui_str': 'Lasers, Excimer'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0040836', 'cui_str': 'Trepanning'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0333606', 'cui_str': 'Dystrophy (morphologic abnormality)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C4521130', 'cui_str': 'Intraocular (intended site)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0022592', 'cui_str': 'Keratoplasty, Penetrating'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0010042', 'cui_str': 'Grafting, Corneal'}]",,0.0337269,"RESULTS ECD did not differ significantly (P ≥ 0.436) between EXCIMER and FEMTO either with ""all-sutures-in"" (1887 ± 409 vs. 1886 ± 438) or with ""all-sutures-out"" (1703 ± 379 vs. 1737 ± 362).","[{'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Tóth', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, Kirrberger Str. 100, 66424, Homburg/Saar, Germany. gabortothgabor@gmail.com.'}, {'ForeName': 'Teona', 'Initials': 'T', 'LastName': 'Butskhrikidze', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, Kirrberger Str. 100, 66424, Homburg/Saar, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Seitz', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, Kirrberger Str. 100, 66424, Homburg/Saar, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Langenbucher', 'Affiliation': 'Experimental Ophthalmology, Saarland University, Kirrberger Str. 100, 66424, Homburg/Saar, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hager', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, Kirrberger Str. 100, 66424, Homburg/Saar, Germany.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Akhmedova', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, Kirrberger Str. 100, 66424, Homburg/Saar, Germany.'}, {'ForeName': 'Moatasem', 'Initials': 'M', 'LastName': 'El-Husseiny', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, Kirrberger Str. 100, 66424, Homburg/Saar, Germany.'}, {'ForeName': 'Nóra', 'Initials': 'N', 'LastName': 'Szentmáry', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, Kirrberger Str. 100, 66424, Homburg/Saar, Germany.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-019-04263-9'] 1192,30856378,Estimating patient-specific treatment advantages in the 'Treatment for Adolescents with Depression Study'.,"The 'Treatment for Adolescents with Depression Study' (TADS, ClinicalTrials.gov, identifier: NCT00006286) was a cornerstone, randomized controlled trial evaluating the effectiveness of standard treatment options for major depression in adolescents. Whereas previous TADS analyses examined primarily effect modifications of treatment-placebo differences by various patient characteristics, less is known about the modification of inter-treatment differences, and hence, patient characteristics that might guide treatment selection. We sought to fill this gap by estimating patient-specific inter-treatment differences as a function of patients' baseline characteristics. We did so by applying the 'model-based random forest', a recently-introduced machine learning-based method for evaluating effect heterogeneity that allows for the estimation of patient-specific treatment effects as a function of arbitrary baseline characteristics. Treatment conditions were cognitive-behavioural therapy (CBT) alone, fluoxetine (FLX) alone, and the combination of CBT and fluoxetine (COMB). All inter-treatment differences (CBT vs. FLX; CBT vs. COMB; FLX vs. COMB) were evaluated across 23 potential effect modifiers extracted from previous studies. Overall, FLX was superior to CBT, while COMB was superior to both CBT and FLX. Evidence for effect heterogeneity was found for the CBT-FLX difference and the FLX-COMB difference, but not for the CBT-COMB difference. Baseline depression severity modified the CBT-FLX difference; whereas baseline depression severity, patients' treatment expectations, and childhood trauma modified the FLX-COMB difference. All modifications were quantitative rather than qualitative, however, meaning that the differences varied only in magnitude, but not direction. These findings imply that combining CBT with fluoxetine may be superior to either therapy used alone across a broad range of patients.",2019,"Evidence for effect heterogeneity was found for the CBT-FLX difference and the FLX-COMB difference, but not for the CBT-COMB difference.","['Adolescents with Depression Study', 'major depression in adolescents']","['fluoxetine', 'cognitive-behavioural therapy (CBT) alone, fluoxetine (FLX) alone, and the combination of CBT and fluoxetine (COMB']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3854046', 'cui_str': 'Comb'}]",[],,0.0408323,"Evidence for effect heterogeneity was found for the CBT-FLX difference and the FLX-COMB difference, but not for the CBT-COMB difference.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Foster', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001, Zürich, Switzerland; Swiss Research Institute for Public Health and Addiction Associated with the University of Zurich, Konradstrasse 32, 8031, Zurich, Switzerland; Department of Child and Adolescent Psychiatry and Psychotherapy (KJPP), University Hospital of Psychiatry Zurich, University of Zurich, Neumünsterallee 9, 8032, Zurich, Switzerland. Electronic address: simon.foster@uzh.ch.'}, {'ForeName': 'Meichun', 'Initials': 'M', 'LastName': 'Mohler-Kuo', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001, Zürich, Switzerland; Swiss Research Institute for Public Health and Addiction Associated with the University of Zurich, Konradstrasse 32, 8031, Zurich, Switzerland; Department of Child and Adolescent Psychiatry and Psychotherapy (KJPP), University Hospital of Psychiatry Zurich, University of Zurich, Neumünsterallee 9, 8032, Zurich, Switzerland; La Source, School of Nursing Sciences, HES-SO University of Applied Sciences and Arts of Western Switzerland, Av. Vinet 30, 1004, Lausanne, Switzerland.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Tay', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001, Zürich, Switzerland.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Hothorn', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001, Zürich, Switzerland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Seibold', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001, Zürich, Switzerland.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.02.021'] 1193,30882604,"A pilot double-blind randomized placebo-controlled crossover pharmacodynamic study of the centrally active aminopeptidase A inhibitor, firibastat, in hypertension.","OBJECTIVES We conducted a pilot multicenter double-blind randomized placebo-controlled crossover pharmacodynamic study to evaluate the blood pressure (BP) and the hormonal effects of firibastat, a first-in-class aminopeptidase A inhibitor prodrug, in patients with hypertension. METHODS Thirty-four patients with daytime ambulatory BP of at least 135/85 mmHg and less than 170/105 mmHg, after a 2-week run-in period were randomly assigned to receive either firibastat (250 mg b.i.d. for 1 week uptitrated to 500 mg b.i.d. for 3 weeks) and then placebo for 4 weeks each or vice versa, with a 2-week washout period on placebo. RESULTS At 4 weeks, daytime ambulatory systolic BP (SBP) decreased by 2.7 mmHg (95% confidence interval -6.5 to +1.1 mmHg) with firibastat versus placebo (P = 0.157). Office SBP decreased by 4.7 mmHg (95% confidence interval -11.1 to +1.8 mmHg) with firibastat versus placebo (P = 0.151). However, more the basal daytime ambulatory SBP was elevated, more the firibastat-induced BP decrease was marked. Firibastat did not influence 24h-ambulatory heart rate. Firibastat had no effect on plasma renin, aldosterone, apelin and copeptin concentrations. No major adverse events occurred. There was one episode of reversible skin allergy with facial edema. CONCLUSION In patients with hypertension, a 4-week treatment with firibastat, tended to decrease daytime SBP relative to placebo. Firibastat did not modify the activity of the systemic renin-angiotensin system These results have justified designing a larger, powered trial of longer duration to fully assess its safety and effectiveness. CLINICAL TRIAL REGISTRATION http://www.clinicaltrials.gov. NCT02322450.",2019,Office SBP decreased by 4.7 mmHg (95% confidence interval -11.1 to +1.8 mmHg) with firibastat versus placebo (P = 0.151).,"['patients with hypertension', 'Thirty-four patients with daytime ambulatory BP of at least 135/85\u200ammHg and less than 170/105']","['firibastat', 'placebo']","['firibastat-induced BP decrease', 'Office SBP', 'daytime SBP relative', 'blood pressure (BP', 'basal daytime ambulatory SBP', 'daytime ambulatory systolic BP (SBP', 'reversible skin allergy with facial edema', 'safety and effectiveness', 'plasma renin, aldosterone, apelin and copeptin concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0585186', 'cui_str': 'Cutaneous hypersensitivity (disorder)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}, {'cui': 'C0056279', 'cui_str': 'C-terminal provasopressin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",34.0,0.304107,Office SBP decreased by 4.7 mmHg (95% confidence interval -11.1 to +1.8 mmHg) with firibastat versus placebo (P = 0.151).,"[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Azizi', 'Affiliation': 'Université Paris-Descartes.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Courand', 'Affiliation': 'University of Lyon.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Denolle', 'Affiliation': 'Cardiology Department, Hôpital Arthur Gardiner, Dinard.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Delsart', 'Affiliation': 'CHU Lille, Institut Cœur Poumon.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zhygalina', 'Affiliation': 'Université Paris-Descartes.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Amar', 'Affiliation': 'Université Paris-Descartes.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lantelme', 'Affiliation': 'University of Lyon.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mounier-Vehier', 'Affiliation': 'CHU Lille, University of Lille, Lille.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'De Mota', 'Affiliation': 'Laboratory of Central Neuropeptides in the Regulation of Body Fluid Homeostasis and Cardiovascular Functions, Center for Interdisciplinary Research in Biology, College de France, PSL Research University, INSERM U1050, CNRS UMR7241, Paris, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Balavoine', 'Affiliation': 'Quantum Genomics SA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Llorens-Cortes', 'Affiliation': 'Laboratory of Central Neuropeptides in the Regulation of Body Fluid Homeostasis and Cardiovascular Functions, Center for Interdisciplinary Research in Biology, College de France, PSL Research University, INSERM U1050, CNRS UMR7241, Paris, France.'}]",Journal of hypertension,['10.1097/HJH.0000000000002092'] 1194,31610337,No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis.,"BACKGROUND & AIMS Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. Topical tacrolimus is effective and safe in patients with refractory UP. However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP. METHODS We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. The primary outcome was clinical response (decrease in Mayo score of 3 or more). Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Outcomes were compared using Fisher's exact test and Mann-Whitney U test. RESULTS Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P = .812); proportions of patients in clinical remission were 46% and 38%, respectively (P = .638). Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P = .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P = .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P = .395). Adverse event rates did not differ significantly between groups. CONCLUSIONS In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. There were no significant differences in adverse events rates. Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416.",2020,"Adverse event rates did not differ significantly between groups. ","['Patients With Refractory Ulcerative Proctitis', 'Eighty-five patients with refractory UP (65% women', 'patients with UP refractory to 5-ASA', 'patients with refractory UP', '8 hospitals in The Netherlands and Belgium from 2014 through 2017']","['Topical tacrolimus', 'tacrolimus', 'tacrolimus suppositories', 'beclomethasone', 'tacrolimus and beclomethasone suppositories', 'Beclomethasone Suppositories', 'Tacrolimus Suppositories', 'Tacrolimus and beclomethasone suppositories', '5-aminosalicylic acid (5-ASA) suppositories']","['clinical response (decrease in Mayo score of 3 or more', 'clinical remission, endoscopic response and remission, adverse events and quality of life', 'Adverse event rates', 'adverse events rates', 'clinical remission', 'endoscopic remission rates', 'endoscopic response', 'inflammatory bowel disease questionnaire score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2937222', 'cui_str': 'Chronic ulcerative proctitis (disorder)'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0004905', 'cui_str': 'Beclomethasone'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",85.0,0.444439,"Adverse event rates did not differ significantly between groups. ","[{'ForeName': 'Mitchell R K L', 'Initials': 'MRKL', 'LastName': 'Lie', 'Affiliation': 'Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Joany E', 'Initials': 'JE', 'LastName': 'Kreijne', 'Affiliation': 'Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Dijkstra', 'Affiliation': 'Gastroenterology and Hepatology, University Medical Center Groningen and University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Löwenberg', 'Affiliation': 'Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'van Assche', 'Affiliation': 'Gastroenterology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'West', 'Affiliation': 'Gastroenterology and Hepatology, Franciscus Hospital and Vlietland Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'van Noord', 'Affiliation': 'Gastroenterology and Hepatology, Franciscus Hospital and Vlietland Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'van der Meulen-de Jong', 'Affiliation': 'Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Rianne J', 'Initials': 'RJ', 'LastName': 'Zaal', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Bettina E', 'Initials': 'BE', 'LastName': 'Hansen', 'Affiliation': 'Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands; Center for Liver Disease, Toronto General Hospital, Toronto, Canada.'}, {'ForeName': 'Annemarie C', 'Initials': 'AC', 'LastName': 'de Vries', 'Affiliation': 'Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Christien', 'Initials': 'C', 'LastName': 'Janneke van der Woude', 'Affiliation': 'Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands. Electronic address: c.vanderwoude@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.09.049'] 1195,30864058,Comparing Computer-Assisted and Teacher-Implemented Visual Matching Instruction for Children with ASD and/or Other DD.,"This paper compared the effectiveness and efficiency of using computer-assisted instruction (CAI) and teacher-implemented instruction (TII) to teach visual matching skills to students with autism spectrum disorder and/or other developmental disabilities. Four school-aged students participated in this study with an alternating treatment design. The CAI incorporated discrete trial instruction with the gesture-tracking application, while the TII involved traditional one-to-one instruction using flashcards. The results indicated that all students acquired the target matching skills with generalization to similar untaught skills and maintained acquired skills at a high level for up to 5 weeks under both CAI and TII. Both CAI and TII were effective. However, CAI was more efficient than TII in regards to the prompts provided and the duration of instructional sessions. CAI also resulted in more student engagement in independent learning.",2020,The results indicated that all students acquired the target matching skills with generalization to similar untaught skills and maintained acquired skills at a high level for up to 5 weeks under both CAI and TII.,"['Four school-aged students', 'Children with ASD and/or Other DD', 'students with autism spectrum disorder and/or other developmental disabilities']","['Computer-Assisted and Teacher-Implemented Visual Matching Instruction', 'computer-assisted instruction (CAI) and teacher-implemented instruction (TII) to teach visual matching skills']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009597', 'cui_str': 'Self-Instruction Programs, Computerized'}]",[],,0.01382,The results indicated that all students acquired the target matching skills with generalization to similar untaught skills and maintained acquired skills at a high level for up to 5 weeks under both CAI and TII.,"[{'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Special Education, Education Research Center for Children with ASD, Faculty of Education, Beijing Normal University, Rm 408, YingDong Building, Xin Jie Kou Wai Da Jie #19, Beijing, China.'}, {'ForeName': 'Gabrielle T', 'Initials': 'GT', 'LastName': 'Lee', 'Affiliation': 'Faculty of Education, Western University, 1137 Western Road, Room 1105, London, ON, N6G 1G7, Canada.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Tsai', 'Affiliation': 'Department of Computer Science and Engineering, Yuan Ze University, 135 Yuandong Road, Zhongli District, Taoyuan, Taiwan, ROC.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Education Technology, Faculty of Education, Beijing Normal University, Rm 215, Yanbo Building, Xin Jie Kou Wai Da Jie #19, Beijing, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'School of Education Technology, Faculty of Education, Beijing Normal University, Mailbox #65, Xin Jie Kou Wai Da Jie #19, Beijing, China. caisu@bnu.edu.cn.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03978-2'] 1196,30559073,Cetuximab monotherapy and cetuximab plus capecitabine as first-line treatment in older patients with RAS- and BRAF wild-type metastatic colorectal cancer. Results of the multicenter phase II trial SAKK 41/10.,"INTRODUCTION While the anti-VEGF antibody bevacizumab was studied repeatedly as part of low-intensity regimens in less fit elderly patients with metastatic colorectal cancer (mCRC), anti-EGFR antibodies as upfront treatment modality have been scarcely investigated. MATERIAL AND METHODS In SAKK 41/10, the benefit of cetuximab, either alone or in combination with capecitabine, was evaluated in vulnerable elderly patients with RAS/BRAF-wild-type mCRC. RESULTS AND DISCUSSION The trial was stopped prematurely due to slow accrual after the inclusion of 24 patients (11 in the monotherapy arm, 13 in the combination arm). Median patient age was 80 years (range 71-89), median CIRS-G score 7 (range 2-13), and median IADL score 7 (range 3-8). At week 12, 6 of 11 patients (55%) were progression-free in the cetuximab monotherapy arm and 9 of 13 patients (69%) in the combination arm. Response rate was 9% in the monotherapy arm and 38% combination arm. The 6 patients with right-sided primary tumors were not responsive to cetuximab. NGS revealed additional mutations affecting the RAS/RAF/MAP kinase pathway in 5 patients; 4 of these patients showed early disease progression. Cetuximab was generally well tolerated and a trend toward an improvement of symptom-related QoL was observed. In the combination arm, a higher incidence of toxicities and treatment stoppings was observed. In conclusion, trial recruitment - requiring both geriatric as well as molecular eligibility criteria - proved more difficult than expected. Bearing in mind the very small sample size, upfront cetuximab treatment appeared tolerable and showed promising activity in left-sided tumors in both treatment arms.",2019,Cetuximab was generally well tolerated and a trend toward an improvement of symptom-related QoL was observed.,"['6 patients with right-sided primary tumors', 'older patients with RAS- and BRAF wild-type metastatic colorectal cancer', '24 patients (11 in the monotherapy arm, 13 in the combination arm', 'vulnerable elderly patients with RAS/BRAF-wild-type mCRC', 'elderly patients with metastatic colorectal cancer (mCRC', 'Median patient age was 80\u202fyears (range 71-89), median CIRS-G score 7 (range 2-13), and median IADL score 7 (range 3-8']","['Cetuximab', 'Cetuximab monotherapy and cetuximab plus capecitabine', 'capecitabine', 'VEGF antibody bevacizumab', 'cetuximab']","['tolerated', 'symptom-related QoL', 'toxicities', 'Response rate', 'progression-free']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",6.0,0.0284383,Cetuximab was generally well tolerated and a trend toward an improvement of symptom-related QoL was observed.,"[{'ForeName': 'Dirk L', 'Initials': 'DL', 'LastName': 'Kienle', 'Affiliation': 'Kantonsspital Graubünden, Chur, und Universitätsklinikum Ulm, Switzerland. Electronic address: DirkLars.Kienle@ksgr.ch.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dietrich', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ribi', 'Affiliation': 'International Breast Cancer Study Group, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wicki', 'Affiliation': 'Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Quagliata', 'Affiliation': 'Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Ralph C', 'Initials': 'RC', 'LastName': 'Winterhalder', 'Affiliation': 'Kantonsspital Luzern, Luzern, Switzerland.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Koeberle', 'Affiliation': 'Claraspital Basel, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Horber', 'Affiliation': 'Kantonsspital, St. Gallen, Switzerland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bastian', 'Affiliation': 'Kantonsspital Graubünden, Chur, und Universitätsklinikum Ulm, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kueng', 'Affiliation': 'Hôpital Fribourgeois, Fribourg, Switzerland.'}, {'ForeName': 'Piercarlo', 'Initials': 'P', 'LastName': 'Saletti', 'Affiliation': 'Instituto Oncologia della Svizzera Italiana, Bellinzona, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Helbling', 'Affiliation': 'Onkozentrum AG, Zuerich, Zürich, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Baertschi', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Lugli', 'Affiliation': 'Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Juerg', 'Initials': 'J', 'LastName': 'Bernhard', 'Affiliation': 'International Breast Cancer Study Group, Bern, Switzerland; Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Andrieu', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'von Moos', 'Affiliation': 'Kantonsspital Graubünden, Chur, und Universitätsklinikum Ulm, Switzerland.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2018.11.011'] 1197,30445275,Effects of time-varying changes in tobacco and alcohol use on depressive symptoms following pharmaco-behavioral treatment for smoking and heavy drinking.,"BACKGROUND Complete abstinence from alcohol as well as smoking cessation have been shown to predict reductions in depressive symptoms over time. However, whether reducing alcohol use or smoking positively affect depressive symptoms has yet to be examined. The current study examined depressive symptoms as a function of time-varying changes in alcohol use and smoking status following a pharmaco-behavioral treatment addressing smoking cessation and alcohol reduction. METHODS Participants were heavy-drinking smokers (n = 150) followed for 26 weeks after their quit smoking date, with assessments of smoking, alcohol use, and depressive symptoms at baseline and 2, 8, 16, and 26 weeks. RESULTS Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01). Exploratory analyses, which excluded observations in which a participant was abstinent, revealed a significant effect of percent change in cigarettes smoked, modeled continuously, on depressive symptoms, (B = 4.39). By contrast, no differences were observed in depressive symptoms in relation to changes in alcohol use. CONCLUSION It appears that smoking abstinence is associated with improvements in depression as compared to any level of sustained or reduced use and that the magnitude of smoking reduction may be associated with lower depressive symptoms among those who did not quit successfully. If replicated, these findings may inform treatment for individuals for whom depression is a major barrier to cessation and who have been unable or are unwilling to be completely abstinent from smoking.",2019,"RESULTS Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01).","['depressive symptoms following pharmaco-behavioral treatment for smoking and heavy drinking', 'Participants were heavy-drinking smokers (n\u2009=\u2009150) followed for 26 weeks after their quit smoking date, with assessments of smoking, alcohol use, and depressive symptoms at baseline and 2, 8, 16, and 26 weeks']",[],['depressive symptoms'],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0199516,"RESULTS Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01).","[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychological Sciences, Kent State University, 144 Kent Hall, P.O. Box 5190, Kent, OH, 44242-0001, USA; Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA. Electronic address: wlechner@kent.edu.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Sidhu', 'Affiliation': 'Department of Psychological Sciences, Kent State University, 144 Kent Hall, P.O. Box 5190, Kent, OH, 44242-0001, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.09.030'] 1198,32408153,Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis.,"BACKGROUND Fasting-mimicking diets have shown promise in experimental autoimmune encephalitis and are currently being investigated among people with multiple sclerosis (MS). Ensuring adherence to diet changes is critical to determining the efficacy of such interventions. OBJECTIVE Our primary aim was to evaluate the safety and feasibility of several fasting-mimicking diets and investigate whether various levels of clinical support improve diet adherence among people with MS. Secondarily, this study evaluated the impact of fasting-mimicking diets on weight and patient-reported outcomes (PROs). METHODS We conducted three pilot studies (two randomized controlled for 6 months; one randomized with transition to single arm) restricting either the amount or timing of calorie intake over 24 or 48 weeks. Interventions included calorie restriction (daily or intermittently) or time-restricted feeding. Adherence measures varied across studies but were collected at study visits along with weight and PRO data. RESULTS A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported. Overall adherence to the calorie restriction diets was poor. When participants were tasked with maintaining a diet in a pragmatic setting, neither previously completed intense clinical support and education, nor weekly electronic communication throughout the diet period appeared to improve diet adherence. Participants who were able to adhere to a calorie restriction diet predictably lost weight. In contrast to calorie restriction, adherence to a time-restricted feeding (TRF) diet was relatively good. No statistically significant changes in PROs were observed in an intention-to-treat analysis. CONCLUSION The role diet may play in clinical outcomes in MS remains unknown, as class I evidence is lacking. Diet adherence remains a primary barrier to the feasible conduct of large, randomized controlled diet trials. Strict adherence to a TRF dietary change may be more feasible than calorie restriction and should be considered in future fasting-mimicking diet trials. ClinicalTrials.gov Registry:A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis - NCT02647502. A Pragmatic Trial of Dietary Programs in People with Multiple Sclerosis (MS) - NCT02846558.",2020,"No statistically significant changes in PROs were observed in an intention-to-treat analysis. ","['people with MS', 'Participants who were able to adhere to a calorie restriction diet predictably lost weight', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'People with Multiple Sclerosis (MS) - NCT02846558', 'A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported']","['Dietary Programs', 'various fasting-mimicking diets', 'Intermittent Calorie Restriction', 'several fasting-mimicking diets']","['PROs', 'calorie restriction (daily or intermittently) or time-restricted feeding', 'Overall adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",90.0,0.0618671,"No statistically significant changes in PROs were observed in an intention-to-treat analysis. ","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Roman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State. Electronic address: sroman6@jhmi.edu.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Mowry', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102149'] 1199,20427350,Concomitant chemoradiation versus radical radiotherapy in advanced squamous cell carcinoma of oropharynx and nasopharynx using weekly cisplatin: a phase II randomized trial.,"BACKGROUND To know the effectiveness and tolerance of weekly cisplatin added to radiotherapy (RT) in advanced carcinoma of oropharynx and nasopharynx. PATIENTS AND METHODS Stage II-IV cancer patients were randomly assigned to either radical RT, 70 Gy/35 fractions over 7 weeks (RT arm), or chemoradiotherapy (CRT), cisplatin 40 mg/m² weekly for seven doses plus RT. Primary end points were (i) the responses, (ii) toxicity profile, and (iii) overall survival (OS) in two groups. Study period was from June 2003 to July 2005. RESULTS One hundred and fifty-three patients were randomly allocated to the study, 76 in RT arm and 77 in CRT arm. Seventy-one in each arm completed the planned treatment; complete response (CR): 67.1% versus 80.5% in RT and CRT arms (P = 0.04). Grade III and IV toxicity were 16% and 40% in RT and CRT arms, respectively (P = 0.01). There were frequent treatment interruptions (9.3% versus 28.9%; P = 0.003) and hospitalization (20% versus 40.8%) in the CRT group. OS was superior in the CRT arm (P = 0.02): 27 months [95% confidence interval (CI) 15.2-36.8] for RT versus not reached for CRT. Three-year OS was 42% for RT and 62% for CRT group. CRT and CR were independent prognostic factors. CONCLUSION This trial on Indian head and neck squamous cell carcinoma patients confirms that the use of weekly cisplatin is safe and CRT is superior to RT alone resulting in higher OS.",2010,There were frequent treatment interruptions (9.3% versus 28.9%; P = 0.003) and hospitalization (20% versus 40.8%) in the CRT group.,"['Indian head and neck squamous cell carcinoma patients', 'One hundred and fifty-three patients were randomly allocated to the study, 76 in RT arm and 77 in CRT arm', 'advanced squamous cell carcinoma of oropharynx and nasopharynx using weekly', 'advanced carcinoma of oropharynx and nasopharynx', 'Stage II-IV cancer patients']","['cisplatin', 'cisplatin added to radiotherapy (RT', 'radical RT', 'Concomitant chemoradiation versus radical radiotherapy', 'chemoradiotherapy (CRT), cisplatin 40 mg/m² weekly for seven doses plus RT']","['i) the responses, (ii) toxicity profile, and (iii) overall survival (OS', 'hospitalization', 'Grade III and IV toxicity']","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280313', 'cui_str': 'Cancer of oropharynx, squamous cell'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",153.0,0.0863068,There were frequent treatment interruptions (9.3% versus 28.9%; P = 0.003) and hospitalization (20% versus 40.8%) in the CRT group.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Medical Oncology. Electronic address: Atul1@hotmail.com.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Mohanti', 'Affiliation': 'Department of Radiation Oncology.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thakar', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bahadur', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhasker', 'Affiliation': 'Department of Radiation Oncology.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq219'] 1200,31701238,"[""Memory acute""-treatment concept for inpatient remobilization of acutely ill patients with dementia].","BACKGROUND Acute hospitals are generally not designed for people with dementia. Behavioral issues pose the greatest challenge. This article reports on the results of a prospective controlled study designed to assess whether dementia patients benefit from a remobilization strategy in a memory clinic (IG-MA) following hospital discharge. METHODS Between January and September 2018 patients with moderate to severe dementia discharged from hospital following acute episodes were admitted to an IG-MA for remobilization. The IG-MA unit provides specially qualified personnel and an adapted environment. Control groups were formed from the standard remobilization unit (KG1-AGR) and four care homes (KG2-PWH). RESULTS Patients in the IG-MA (n = 22) had a worse functional status at admission according to the Barthel index (BI), the timed ""up and go"" test (TUG) and the Esslinger transfer scale (ETS) than patients in the KG1-AGR (n = 59). Outcomes significantly improved in both groups (IG-MA and KG1-AGR) without a clear difference between groups: IG-MA (BI from 35 to 57.8 points, TUG from 30.8 s to 23 s, ETS from 2.1 to 1.1 points) vs. KG1-AGR (BI from 44.7 to 62.4 points, TUG from 28.6 s to 20.2 s, ETS from 1.7 to 0.9 points). There were differences in cognitive ability at admission (mini mental state examination, MMSE: IG-MA 13.6 points vs. KG1-AGR 20 points). The length of stay in the IG-MA was on average 5 days longer. Early discharge was mostly the result of complications and transfer to acute hospitals in the IG-MA group (22.7%) and in the KG1-AGR group this was mostly due to care issues (27.1%). The KG2-PWH group did not show any significant functional improvements in the first 4 weeks as measured by the BI. CONCLUSION Moderate to severely affected dementia patients with behavioral problems benefited from treatment in a specially designed remobilization unit following hospital discharge after an acute event.",2020,"There were differences in cognitive ability at admission (mini mental state examination, MMSE: IG-MA 13.6 points vs. KG1-AGR 20 points).","['Between January and September 2018 patients with moderate to severe dementia discharged from hospital following acute episodes were admitted to an IG-MA for remobilization', 'Moderate to severely affected dementia patients with behavioral problems', 'people with dementia', 'acutely ill patients with dementia', 'dementia patients benefit from a\xa0remobilization strategy in a\xa0memory clinic (IG-MA) following hospital discharge']","['KG1-AGR', 'IG-MA', 'standard remobilization unit (KG1-AGR) and four care homes (KG2-PWH', 'KG2-PWH']","['timed ""up and go"" test (TUG) and the Esslinger transfer scale (ETS', 'length of stay', 'cognitive ability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0185113', 'cui_str': 'Remobilization'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185113', 'cui_str': 'Remobilization'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0222045'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",2018.0,0.0332966,"There were differences in cognitive ability at admission (mini mental state examination, MMSE: IG-MA 13.6 points vs. KG1-AGR 20 points).","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Pichler', 'Affiliation': 'Albert Schweitzer Klinik Graz, Albert Schweitzer Gasse\xa036, 8020, Graz, Österreich. gerald.pichler@stadt.graz.at.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fink', 'Affiliation': 'Albert Schweitzer Klinik Graz, Albert Schweitzer Gasse\xa036, 8020, Graz, Österreich.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Weidinger', 'Affiliation': 'Albert Schweitzer Klinik Graz, Albert Schweitzer Gasse\xa036, 8020, Graz, Österreich.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Schmidt', 'Affiliation': 'Joanneum Research Forschungsgesellschaft mbH - Health, Graz, Österreich.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Augustin', 'Affiliation': 'Joanneum Research Forschungsgesellschaft mbH - Health, Graz, Österreich.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Schippinger', 'Affiliation': 'Albert Schweitzer Klinik Graz, Albert Schweitzer Gasse\xa036, 8020, Graz, Österreich.'}]",Zeitschrift fur Gerontologie und Geriatrie,['10.1007/s00391-019-01642-z'] 1201,30789583,Chronic Effects of Static and Dynamic Stretching on Hamstrings Eccentric Strength and Functional Performance: A Randomized Controlled Trial.,"Barbosa, GM, Trajano, GS, Dantas, GAF, Silva, BR, and Vieira, WHB. Chronic effects of static and dynamic stretching on hamstrings eccentric strength and functional performance: A randomized controlled trial. J Strength Cond Res 34(7): 2031-2039, 2020-The purpose of this study was to investigate the effect of static or dynamic stretching training program on hamstrings eccentric peak torque and functional performance. Forty-five active healthy men were randomly allocated into 3 groups (n = 15 per group): no stretching (control), static stretching (3 sets of 30 seconds), and dynamic stretching (3 sets of 30 repetitions). Static and dynamic stretching protocols on the hamstring muscles were performed 3 times a week until complete 10 sessions. Isokinetic knee flexor eccentric peak torque (60°·s), triple hop distance, and modified 20-m sprint time were assessed in a random order before and after stretching training. A mixed-design analysis of variance was performed, with an alpha level of 0.05. There was a significant decrease of eccentric peak torque (p ≤ 0.0001, -15.4 ± 10.4%, within-group effect size: 1.03) after static stretching training. The static stretching training reduced eccentric torque when compared with no stretching (-7.6 ± 21.7%, between-group effect size: 0.50) and dynamic stretching (-7.8 ± 29.8%, between-group effect size: 0.51). Moreover, the reached distance on triple hop test was also reduced after static stretching protocol (p = 0.009, -3.7 ± 4.1%, within-group effect size: 0.29). These findings suggest that static stretching training is sufficient to produce meaningful reductions on hamstrings eccentric torque and functional performance. Based on the results of this study, caution should be taken when prescribing of static stretching training in isolation when the purpose is to improve performance, and indirectly, to prevent hamstring strain injuries due to its possible negative effects on hopping performance and knee flexor eccentric torque.",2020,"Moreover, the reached distance on triple hop test was also reduced after static stretching protocol (p = 0.009, -3.7 ± 4.1%, within-group effect size: 0.29).",['Forty-five active healthy men'],"['J Strength Cond Res XX(X', 'Static and dynamic stretching protocols', 'static and dynamic stretching', 'Static and Dynamic Stretching', 'static stretching training', 'static or dynamic stretching training program', 'no stretching (control), static stretching (3 sets of 30 seconds), and dynamic stretching']","['hamstrings eccentric strength and functional performance', 'Isokinetic knee flexor eccentric peak torque (60°·s), triple hop distance, and modified 20-m sprint time', 'Hamstrings Eccentric Strength and Functional Performance', 'eccentric torque', 'hamstrings eccentric peak torque and functional performance', 'Barbosa, GM, Trajano, GS, Dantas, GAF, Silva, BR, and Vieira, WHB', 'eccentric peak torque', 'hamstrings eccentric torque and functional performance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1720869', 'cui_str': 'Dynamic Stretching'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",45.0,0.0212715,"Moreover, the reached distance on triple hop test was also reduced after static stretching protocol (p = 0.009, -3.7 ± 4.1%, within-group effect size: 0.29).","[{'ForeName': 'Germanna M', 'Initials': 'GM', 'LastName': 'Barbosa', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Trajano', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Glauko A F', 'Initials': 'GAF', 'LastName': 'Dantas', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Bianca R', 'Initials': 'BR', 'LastName': 'Silva', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Wouber H Brito', 'Initials': 'WHB', 'LastName': 'Vieira', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003080'] 1202,30798143,An evaluation of an integrated fluency and resilience program for early developmental stuttering disorders.,"PURPOSE The temperament construct of effortful control, an index of self-regulation and resilience, has been found to be predictive of stuttering severity in children and is a potential indicator of clinical prognosis. Evidence supports early intervention for preschool stuttering, and the successful effect of parents as agents of change in their children's stuttering therapy. However, no previous studies have trained parents to improve self-regulation in their children as a component of stuttering therapy. This study aimed to explore the effects of addressing self-regulation, as a component of stuttering treatment, on child fluency as well as parent and child psychosocial outcomes. METHODS This study implemented a preliminary parent administered resilience component in conjunction with stuttering therapy for children who stutter, and compared outcomes to a cohort of children who stutter who received stuttering therapy only. Twenty-eight children who stutter were randomly allocated to one of the two treatment groups. Dependent variables tested pre- and post-treatment included stuttered speech severity, parenting practices, and child resilience indicators. Outcomes were compared between groups at post treatment. RESULTS Stuttered speech severity decreased in both treatment groups. A reduction in behavioural and emotional problems, and increase in resilience was observed in the children who stutter whose parents received the additional resilience component of therapy. Furthermore, a significant improvement in parenting practices was demonstrated in this group. No significant changes in emotional and behavioural problems in children or parents were observed in the group of children who received fluency therapy only. CONCLUSION Results demonstrate that implementation of the resilience component was successful in positively shifting parenting practices and increasing behavioural resilience in children who stutter. This has clinical implications for successfully managing fluency while concurrently targeting the concomitant behavioural and emotional impacts of the disorder on both children and parents, potentially a key future prognostic indicator of the maintenance of fluency outcomes.",2019,"No significant changes in emotional and behavioural problems in children or parents were observed in the group of children who received fluency therapy only. ","['early developmental stuttering disorders', 'children who stutter, and compared outcomes to a cohort of children who stutter who received stuttering therapy only', 'children who stutter', 'Twenty-eight children who stutter']",['integrated fluency and resilience program'],"['behavioural and emotional problems', 'stuttered speech severity, parenting practices, and child resilience indicators', 'parenting practices', 'behavioural resilience', 'emotional and behavioural problems']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0751529', 'cui_str': 'Stuttering, Developmental'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]",28.0,0.0395576,"No significant changes in emotional and behavioural problems in children or parents were observed in the group of children who received fluency therapy only. ","[{'ForeName': 'Kerianne C', 'Initials': 'KC', 'LastName': 'Druker', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Western Australia, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Mazzucchelli', 'Affiliation': 'School of Psychology, Curtin University, Western Australia, Australia.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Beilby', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Western Australia, Australia. Electronic address: J.Beilby@curtin.edu.au.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2019.02.002'] 1203,30797045,"C-reactive protein, Epstein-Barr virus, and cortisol trajectories in refugee and non-refugee youth: Links with stress, mental health, and cognitive function during a randomized controlled trial.","Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion. Relatively few studies have examined, longitudinally, alterations to inflammatory processes during adolescence, especially outside Western contexts; none have evaluated biomarker trajectories for at-risk youth in response to a structured behavioral intervention. We conducted a randomized controlled trial evaluating the efficacy of a humanitarian intervention targeting stress-alleviation, with 12-18 year-old Syrian refugees (n = 446) and Jordanian non-refugees (n = 371) living side-by-side in war-affected communities in Jordan. We measured C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC) at three timepoints (pre/post intervention and 11 month follow-up), and assessed three main outcomes (psychosocial stress, mental health, and cognitive function). Using growth mixture models, regressions, and growth curve models, we identified three distinct trajectories for CRP, two for EBV, and three for HCC, and examined their associations with age, gender, BMI, poverty, and trauma. We found associations with BMI for CRP, refugee status for EBV, and BMI and gender with HCC trajectory. In terms of health outcomes, we found associations between rising CRP levels and perceived stress (B =  -2.92, p = .007), and between HCC hypersecretion and insecurity (B = 7.21, p = .017). In terms of responses to the intervention, we observed no differential impacts by CRP or EBV trajectories, unlike HCC. These results suggest that commonly-assayed biomarkers do not associate with health outcomes and respond to targeted interventions in straightforward ways. Our study is the first to examine multiple biomarker trajectories in war-affected adolescents, in order to better evaluate the extent, timing, and malleability of the biological signatures of poverty, conflict, and forced displacement.",2020,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.",['12-18\u202fyear-old Syrian refugees (n\u202f=\u202f446) and Jordanian non-refugees (n\u202f=\u202f371) living side-by-side in war-affected communities in Jordan'],['humanitarian intervention'],"['main outcomes (psychosocial stress, mental health, and cognitive function', 'C-reactive protein, Epstein-Barr virus, and cortisol trajectories', 'C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC', 'rising CRP levels and perceived stress', 'HCC hypersecretion and insecurity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0236525', 'cui_str': 'Epstein-Barr virus antibody (substance)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0233497', 'cui_str': 'Insecurity (finding)'}]",,0.0231915,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Panter-Brick', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA. Electronic address: catherine.panter-brick@yale.edu.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Wiley', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Sancilio', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Dajani', 'Affiliation': 'Department of Biology and Biotechnology, Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Hadfield', 'Affiliation': 'Department of Biological and Experimental Psychology, Queen Mary University of London, UK.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.02.015'] 1204,31742849,Five-year results of a modified left atrial maze IV procedure in the treatment of atrial fibrillation: a randomized study.,"BACKGROUND The left atrial maze IV (LAM-IV) alone has been used to eliminate atrial fibrillation (AF) without severe right heart diseases. However, we felt that it could be improved and developed a modified LAM-IV (MLAM-IV). In this prospective trial, we aimed to investigate 5-year clinical outcomes of AF in patients treated by the novel MLAM-IV technique. METHODS Between September 2012 and October 2013, 120 patients who underwent valve surgery and bipolar radiofrequency ablation for AF were randomized into the LAM-IV group (n = 60) or MLAM-IV group (n = 60). At postoperative follow-up examinations, data were recorded at 1, 3 and 6 months, and annually thereafter. RESULTS The mean ablation time and postoperative ventilation time were shorter in the MLAM-IV group than in the LAM-IV group (P < 0.001 and P = 0.03, respectively). At 5 years, the rate of freedom from AF was 69.0% in the MLAM-IV group and 60.0% in the LAM-IV group (hazard ratio 0.71, 95% confidence interval 0.39 to 1.32, P = 0.42). There were no differences with respect to the early operative mortality and major complications, late mortality, and major adverse events. CONCLUSIONS The MLAM-IV provides a technically simpler ablation process. The MLAM-IV was associated with less ventilation support in the early postoperative period. The long-term efficacy of the MLAM-IV in the treatment of AF is comparable to that of the LAM-IV.",2020,"The mean ablation time and postoperative ventilation time were shorter in the MLAM-IV group than in the LAM-IV group (P < 0.001 and P = 0.03, respectively).","['atrial fibrillation', 'Between September 2012 and October 2013, 120 patients who underwent', 'patients treated by the novel MLAM-IV technique']","['modified left atrial maze IV procedure', 'MLAM-IV', 'LAM-IV group (n =\u200960) or MLAM-IV group', 'valve surgery and bipolar radiofrequency ablation for AF']","['rate of freedom from AF', 'mean ablation time and postoperative ventilation time', 'early operative mortality and major complications, late mortality, and major adverse events']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.0358957,"The mean ablation time and postoperative ventilation time were shorter in the MLAM-IV group than in the LAM-IV group (P < 0.001 and P = 0.03, respectively).","[{'ForeName': 'Dengshen', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Huayan', 'Initials': 'H', 'LastName': 'Quan', 'Affiliation': 'West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yingqiang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}]",ANZ journal of surgery,['10.1111/ans.15486'] 1205,30783449,Efficacy of dexmedetomidine in reducing post-operative pain and improving the quality of recovery in patients with burn wounds undergoing tangential excision skin grafting.,"Burn-induced acute post-operative pain and the associated stress response may result in prolonged convalescence. The present study investigated the effects of dexmedetomidine (DEX) administration on post-operative pain and the quality of recovery following surgical treatment of moderate-to-severe burn injuries. A total of 60 adult patients undergoing tangential excision skin grafting were randomized into two groups. The DEX group (Group D) received an intravenous (i.v.) single-dose bolus injection of DEX 0.5 µg/kg >10 min prior to induction of anesthesia. Patient-controlled intravenous analgesia (PCIA) was provided to the patients from the end of the surgery, which consisted of 100 µg sufentanil plus 200 µg DEX. The control group (Group C) received an equal volume of normal saline as a pre-operative bolus and post-operative PCIA of 100 µg sufentanil infusion. The Visual Analogue Scale (VAS) score at rest and during movement, the cumulative dose of sufentanil and the 40-item quality of recovery questionnaire (QoR-40) score were assessed at various time-points after the surgery. During the first 24 h post-surgery, patients in Group D exhibited a lower VAS score at rest and during movement, a lower number of PCIA pump presses (29.17±1.91 vs. 34.13±2.73) and lower sufentanil consumption (62.58±0.96 vs. 65.27±1.26) compared with those in Group C (P<0.05). Furthermore, the QoR-40 recovery score of patients in Group D at 24 h post-surgery was higher compared with that in Group C (P<0.01). In conclusion, the present study indicated that a pre-operative bolus of DEX (0.5 µg/kg) followed by DEX plus sufentanil by PCIA subsequent to surgery improved the quality of analgesia and promoted the quality of recovery at 24 h following tangential excision skin grafting treatment of patients with moderate-to-severe burn injuries compared to PCIA of 100 µg sufentanil only. The present study was retrospectively registered with the trial registration no. ChiCTR1800016646 (date of registration, 14/06/2018).",2019,"During the first 24 h post-surgery, patients in Group D exhibited a lower VAS score at rest and during movement, a lower number of PCIA pump presses (29.17±1.91 vs. 34.13±2.73) and lower sufentanil consumption (62.58±0.96 vs. 65.27±1.26) compared with those in Group C (P<0.05).","['moderate-to-severe burn injuries', 'patients with burn wounds undergoing tangential excision skin grafting', '60 adult patients undergoing tangential excision skin grafting']","['dexmedetomidine (DEX', 'DEX', 'equal volume of normal saline', 'Patient-controlled intravenous analgesia (PCIA', 'DEX plus sufentanil', 'dexmedetomidine', 'sufentanil plus 200 µg DEX']","['quality of recovery', 'Visual Analogue Scale (VAS) score at rest and during movement, the cumulative dose of sufentanil and the 40-item quality of recovery questionnaire (QoR-40) score', 'QoR-40 recovery score', 'number of PCIA pump presses', 'VAS score', 'quality of analgesia', 'sufentanil consumption']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.136596,"During the first 24 h post-surgery, patients in Group D exhibited a lower VAS score at rest and during movement, a lower number of PCIA pump presses (29.17±1.91 vs. 34.13±2.73) and lower sufentanil consumption (62.58±0.96 vs. 65.27±1.26) compared with those in Group C (P<0.05).","[{'ForeName': 'Meiru', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}, {'ForeName': 'Qiaoxia', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}, {'ForeName': 'Ganggang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': 'Operating Room, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}, {'ForeName': 'Jiahai', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2019.7155'] 1206,20439345,Liposomal cisplatin combined with paclitaxel versus cisplatin and paclitaxel in non-small-cell lung cancer: a randomized phase III multicenter trial.,"BACKGROUND Liposomal cisplatin is a new formulation developed to reduce the systemic toxicity of cisplatin while simultaneously improving the targeting of the drug to the primary tumor and to metastases by increasing circulation time in the body fluids and tissues. The primary objectives were to determine nephrotoxicity, gastrointestinal side-effects, peripheral neuropathy and hematological toxicity and secondary objectives were to determine the response rate, time to tumor progression (TTP) and survival. PATIENTS AND METHODS Two hundred and thirty-six chemotherapy-naive patients with inoperable non-small-cell lung cancer were randomly allocated to receive either 200 mg/m² of liposomal cisplatin and 135 mg/m² paclitaxel (arm A) or 75 mg/m² cisplatin and 135 mg/m² paclitaxel (arm B), once every 2 weeks on an outpatient basis. Two hundred and twenty-nine patients were assessable for toxicity, response rate and survival. Nine treatment cycles were planned. RESULTS Arm A patients showed statistically significant lower nephrotoxicity, grade 3 and 4 leucopenia, grade 2 and 3 neuropathy, nausea, vomiting and fatigue. There was no significant difference in median and overall survival and TTP between the two arms; median survival was 9 and 10 months in arms A and B, respectively, and TTP was 6.5 and 6 months in arms A and B, respectively. CONCLUSIONS Liposomal cisplatin in combination with paclitaxel has been shown to be much less toxic than the original cisplatin combined with paclitaxel. Nephrotoxicity in particular was negligible after liposomal cisplatin administration. TTP and survival were similar in both treatment arms.",2010,"There was no significant difference in median and overall survival and TTP between the two arms; median survival was 9 and 10 months in arms A and B, respectively, and TTP was 6.5 and 6 months in arms A and B, respectively. ","['non-small-cell lung cancer', 'Two hundred and thirty-six chemotherapy-naive patients with inoperable non-small-cell lung cancer']","['200 mg/m² of liposomal cisplatin and 135 mg/m² paclitaxel (arm A) or 75 mg/m² cisplatin and 135 mg/m² paclitaxel', 'Liposomal cisplatin', 'Liposomal cisplatin combined with paclitaxel versus cisplatin and paclitaxel', 'paclitaxel']","['median survival', 'response rate, time to tumor progression (TTP) and survival', 'toxicity, response rate and survival', 'median and overall survival and TTP', 'TTP and survival', 'systemic toxicity', 'nephrotoxicity, gastrointestinal side-effects, peripheral neuropathy and hematological toxicity', 'Nephrotoxicity', 'nephrotoxicity, grade 3 and 4 leucopenia, grade 2 and 3 neuropathy, nausea, vomiting and fatigue']","[{'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",236.0,0.266192,"There was no significant difference in median and overall survival and TTP between the two arms; median survival was 9 and 10 months in arms A and B, respectively, and TTP was 6.5 and 6 months in arms A and B, respectively. ","[{'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Stathopoulos', 'Affiliation': 'First Oncology Clinic, Errikos Dunant Hospital. Electronic address: dr-gps@ath.forthnet.gr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Antoniou', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dimitroulis', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Michalopoulou', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bastas', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Marosis', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stathopoulos', 'Affiliation': 'First Oncology Clinic, Errikos Dunant Hospital.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Provata', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Yiamboudakis', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Veldekis', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lolis', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Georgatou', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toubis', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Pappas', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tsoukalas', 'Affiliation': 'Pneumonology Clinics, Hospital of Thoracic Disorders, Athens, Greece.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq234'] 1207,30777988,Transfascial suture versus tack fixation of mesh in totally extraperitoneal repair of inguinal hernia: A prospective comparative study.,"Purpose Among laparoscopic surgeries in inguinal hernias, totally extraperitoneal (TEP) repair has demonstrated favourable results in reduction of post-operative pain and mean operative times with early return to physical activity. We have done a prospective comparative study on two different techniques of mesh fixation, i.e., transfascial suture and tack fixation. Materials and Methods It was a prospective, non-randomised comparative study done on inguinal hernia patients operated by TEP repair from October 2014 to September 2016. These data were compared in two techniques of mesh fixation (tack and transfascial sutures) in terms of post-operative complications, pain scores by visual analogue scale (VAS) and cost analysis of the procedure. Results Our study on 69 total patients (44 tack fixation and 25 suture fixation group) revealed that mean VAS scores for post-operative pain were not having any statistically significant difference in the tack group versus suture group (2.42 ± 0.24 vs. 2.2 ± 0.24) at 24 h, but VAS scores in the follow-up period at 1 week, 1 month, 3 months and 6 months were 1.14 ± 0.33 versus 0.67 ± 0.27; 0.78 ± 0.24 versus 0.07 ± 0.06; 0.42 ± 0.17 versus 0.07 ± 0.06 and 0.5 ± 0.11 versus 0.07 ± 0.06, respectively, which showed significant difference at 1 and 3 months, suggesting less pain in the suture group. No significant difference was noted in other post-operative complications. Conclusion Transfascial suture fixation of mesh in TEP repair of inguinal hernia can be a cost-effective procedure with a comparable safety profile as compared to tack fixation.",2019,"No significant difference was noted in other post-operative complications. ","['totally extraperitoneal repair of inguinal hernia', '69 total patients (44 tack fixation and 25 suture fixation group', 'inguinal hernia patients operated by TEP repair from October 2014 to September 2016']","['inguinal hernias, totally extraperitoneal (TEP) repair', 'laparoscopic surgeries', 'Transfascial suture versus tack fixation of mesh', 'transfascial suture and tack fixation', 'mesh fixation (tack and transfascial sutures']","['mean VAS scores for post-operative pain', 'VAS scores', 'pain', 'pain scores by visual analogue scale (VAS) and cost analysis of the procedure']","[{'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3874006', 'cui_str': 'Tack'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C3874006', 'cui_str': 'Tack'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0010171', 'cui_str': 'Cost Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",69.0,0.0325498,"No significant difference was noted in other post-operative complications. ","[{'ForeName': 'Awanish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgery, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Pal', 'Affiliation': 'Department of Surgery, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Anuraag', 'Initials': 'A', 'LastName': 'Choudhary', 'Affiliation': 'Department of Surgery, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Surgery, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Abhinav Arun', 'Initials': 'AA', 'LastName': 'Sonkar', 'Affiliation': 'Department of Surgery, King George Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Harvinder Singh', 'Initials': 'HS', 'LastName': 'Pahwa', 'Affiliation': 'Department of Surgery, King George Medical University, Lucknow, Uttar Pradesh, India.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_192_18'] 1208,30797381,"Comparing satisfaction, alliance and intervention components in electronically delivered and in-person brief interventions for substance use among childbearing-aged women.","Electronic delivery of Screening, Brief Intervention, and Referral to Treatment (e-SBIRT) may be a low-cost and high-reach method for screening and brief intervention in health care settings. However, its relative acceptability, ability to build a therapeutic alliance, and delivery of key intervention components compared to in-person SBIRT (SBIRT) is unclear. The association of these factors with intervention outcomes is also not known. We compared SBIRT and e-SBIRT on satisfaction, alliance, and receipt of intervention components, and evaluated the extent to which these intervention dimensions were related to later substance use. Data were collected as part of a randomized clinical trial (N = 439) examining SBIRT, e-SBIRT, and enhanced usual care for childbearing-aged women in two reproductive healthcare clinics (see Martino et al. (2018) for main trial findings). Participants receiving SBIRT or e-SBIRT (N = 270) rated satisfaction and alliance following a single-session, brief intervention, based on motivational interviewing that targeted hazardous substance use (tobacco, alcohol, illicit drugs and prescribed medications). Trained raters coded audio-recorded SBIRT sessions for the presence of six major intervention components, and evaluated the occurrence of these components in the e-SBIRT software. Overall, participants in both groups reported strong satisfaction (on average, ""considerably"" to ""extremely"" satisfied) and perceived working alliance (on average, ""very often"" to ""always"" allied). SBIRT participants provided higher overall alliance ratings, felt more encouraged to make their own decisions, and rated the intervention's likely helpfulness to other women higher. Fewer e-SBIRT participants received intervention components focusing on personalized feedback, developing importance of and confidence in making changes to substance use, and developing a plan to change, compared to SBIRT participants. However, e-SBIRT participants were equally or more likely to receive components seeking to help them understand their use, discussing reasons for use, and summarizing and supporting what the patients elected to do. Notably, satisfaction, alliance, and number of intervention components received were not associated with total days of substance use. Although we found no evidence that the intervention characteristics evaluated in this study were associated with outcomes, acceptability and alliance may have other important implications. Findings suggest areas for improvement with respect to e-SBIRT satisfaction and alliance formation. ClinicalTrials.govregistration number: NCT01539525.",2019,"SBIRT participants provided higher overall alliance ratings, felt more encouraged to make their own decisions, and rated the intervention's likely helpfulness to other women higher.","['childbearing-aged women in two reproductive healthcare clinics (see Martino et al', 'childbearing-aged women']","['SBIRT', 'motivational interviewing that targeted hazardous substance use (tobacco, alcohol, illicit drugs and prescribed medications', 'Electronic delivery of Screening, Brief Intervention, and Referral to Treatment (e-SBIRT']","['overall alliance ratings', 'strong satisfaction', 'satisfaction, alliance, and number of intervention components']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0018626', 'cui_str': 'Hazardous Materials'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",,0.0455781,"SBIRT participants provided higher overall alliance ratings, felt more encouraged to make their own decisions, and rated the intervention's likely helpfulness to other women higher.","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Loree', 'Affiliation': 'VA Connecticut Healthcare System, 950 Campbell Ave, West Haven, CT 06516, USA; Department of Psychiatry, Yale University School of Medicine, 300 George St, Suite 900, New Haven, CT 06511, USA. Electronic address: aloree1@hfhs.org.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George St, Suite 900, New Haven, CT 06511, USA. Electronic address: kimberly.yonkers@yale.edu.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Merrill Palmer Skillman Institute, Department of Psychiatry & Behavioral Neurosciences, Wayne State University, 71 E. Ferry St, Detroit, MI 48201, USA. Electronic address: s.ondersma@wayne.edu.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George St, Suite 900, New Haven, CT 06511, USA. Electronic address: kathryn.gilstad-hayden@yale.edu.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'VA Connecticut Healthcare System, 950 Campbell Ave, West Haven, CT 06516, USA; Department of Psychiatry, Yale University School of Medicine, 300 George St, Suite 900, New Haven, CT 06511, USA. Electronic address: steve.martino@yale.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.007'] 1209,30797394,Factors influencing recruitment to a randomised placebo-controlled trial of oral naltrexone and extended release implant naltrexone: Qualitative study.,"AIMS To understand the influences on recruitment to the Naltrexone Enhanced Addiction Treatment (NEAT) study, a randomised placebo-controlled trial of extended-release naltrexone (XR-NTX) implants for opioid use disorder (OUD), to learn lessons for the design and conduct of similar future research. METHODS 29 face-to-face, semi-structured qualitative interviews were conducted with patients recruited to NEAT (n = 6), patients not recruited (n = 11), researchers who designed the trial (n = 5), and staff who delivered the trial (n = 7). The social marketing mix was used as a framework to guide the data analyses. RESULTS Dimensions of the 7Ps of the social marketing mix - product, price, place, promotion, physical environment, people, and processes all influenced recruitment to the NEAT trial. Among other things, the potential to receive a naltrexone implant (product); the provision of transport passes and shopping vouchers (price); clear verbal explanations (promotion); familiarity of the trial setting (physical environment); and approachable, friendly and informative trial delivery staff (people) positively influenced recruitment. Whereas, wanting a less medical approach to recovery (product); the perceived time, physical, and psychological costs of taking part (price); service ideological opposition to naltrexone in recovery (place); inaccessible written information (promotion); the location and nature of the trial setting (physical environment); a lack of knowledge about implants (people); and the blind allocation and potential of placebo (processes) deterred people from joining the trial. CONCLUSIONS Qualitative research informed by the social marketing mix as an analytical framework yielded detailed insights into understanding the factors and circumstances that influenced recruitment to the NEAT trial. Our findings have implications for the planning and implementation of future addiction trials, especially trials of extended-release formulations.",2019,"To understand the influences on recruitment to the Naltrexone Enhanced Addiction Treatment (NEAT) study, a randomised placebo-controlled trial of extended-release naltrexone (XR-NTX) implants for opioid use disorder (OUD), to learn lessons for the design and conduct of similar future research. ","['29 face-to-face, semi-structured qualitative interviews were conducted with patients recruited to NEAT (n\u202f=\u202f6), patients not recruited (n\u202f=\u202f11), researchers who designed the trial (n\u202f=\u202f5), and staff who delivered the trial (n\u202f=\u202f7']","['placebo', 'naltrexone (XR-NTX', 'naltrexone', 'oral naltrexone', 'Naltrexone']","['time, physical, and psychological costs of taking part (price); service ideological opposition to naltrexone in recovery (place); inaccessible written information (promotion); the location and nature of the trial setting (physical environment']","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0557720', 'cui_str': 'Physical environment (environment)'}]",,0.0942228,"To understand the influences on recruitment to the Naltrexone Enhanced Addiction Treatment (NEAT) study, a randomised placebo-controlled trial of extended-release naltrexone (XR-NTX) implants for opioid use disorder (OUD), to learn lessons for the design and conduct of similar future research. ","[{'ForeName': 'Charlotte N E', 'Initials': 'CNE', 'LastName': 'Tompkins', 'Affiliation': ""King's College London, National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, 4 Windsor Walk, London SE5 8BB, United Kingdom. Electronic address: Charlotte.tompkins@kcl.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""King's College London, National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, 4 Windsor Walk, London SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, Australia; South London & Maudsley (SLaM) NHS Foundation Trust, Maudsley Hospital, Denmark Hill, London SE5 8BB, United Kingdom. Electronic address: Joanne.neale@kcl.ac.uk.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': ""King's College London, National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, 4 Windsor Walk, London SE5 8BB, United Kingdom. Electronic address: John.marsden@kcl.ac.uk.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""King's College London, National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, 4 Windsor Walk, London SE5 8BB, United Kingdom; South London & Maudsley (SLaM) NHS Foundation Trust, Maudsley Hospital, Denmark Hill, London SE5 8BB, United Kingdom. Electronic address: John.strang@kcl.ac.uk.""}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.012'] 1210,30762895,Lusutrombopag for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Invasive Procedures (L-PLUS 2).,"Thrombocytopenia may be associated with increased bleeding risk impacting timing and outcome of invasive procedures in patients with chronic liver disease (CLD). Lusutrombopag, a small-molecule, thrombopoietin (TPO) receptor agonist, was evaluated as a treatment to raise platelet counts (PCs) in patients with thrombocytopenia and CLD undergoing invasive procedures. L-PLUS 2 was a global, phase 3, randomized, double-blind, placebo-controlled study. Adults with CLD and baseline PCs < 50 × 10 9 /L were randomized to receive once-daily lusutrombopag 3 mg or placebo ≤ 7 days before an invasive procedure scheduled 2-7 days after the last dose. The primary endpoint was avoidance of preprocedure platelet transfusion and avoidance of rescue therapy for bleeding. A key secondary endpoint was number of days PCs were ≥ 50 × 10 9 /L throughout the study. Safety analysis was performed on patients who received at least one dose of study drug. This study occurred between June 15, 2015, and April 19, 2017, with a total of 215 randomized patients (lusutrombopag, 108; placebo, 107); 64.8% (70/108) of patients in the lusutrombopag group versus 29.0% (31/107) in the placebo group met the primary endpoint (P < 0.0001; difference of proportion 95% confidence interval [CI], 36.7 [24.9, 48.5]). The median duration of PCs ≥ 50 × 10 9 /L was 19.2 days with lusutrombopag (without platelet transfusion) compared with 0.0 in the placebo group (with platelet transfusion) (P = 0.0001). Most adverse events were mild or moderate in severity, and rates were similar in the lusutrombopag and placebo groups (47.7% and 48.6%, respectively). Conclusion: Lusutrombopag was superior to placebo for reducing the need for platelet transfusions and achieved durable PC response in patients with thrombocytopenia and CLD undergoing invasive procedures, with a safety profile similar to placebo.",2019,"Lusutrombopag was superior to placebo for reducing the need for platelet transfusions and achieved durable PC response in patients with thrombocytopenia and CLD undergoing invasive procedures, with a safety profile similar to placebo.","['patients with thrombocytopenia and CLD undergoing invasive procedures', 'Patients With Chronic Liver Disease Undergoing Invasive Procedures (L-PLUS 2', 'June 15, 2015, and April 19, 2017, with a total of 215 randomized patients (lusutrombopag, 108; placebo, 107); 64.8% (70/108) of patients in the lusutrombopag group versus 29.0% (31/107) in the', 'Adults with CLD and baseline PCs < 50 × 10 9 /L', 'patients with chronic liver disease (CLD']","['Lusutrombopag', 'lusutrombopag 3 mg or placebo', 'placebo']","['median duration of PCs', 'avoidance of preprocedure platelet transfusion and avoidance of rescue therapy for bleeding', 'number of days PCs were\xa0≥', 'durable PC response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0055926', 'cui_str': 'endogenous clonidine-like substance'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4309207', 'cui_str': 'lusutrombopag'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4309207', 'cui_str': 'lusutrombopag'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",215.0,0.721738,"Lusutrombopag was superior to placebo for reducing the need for platelet transfusions and achieved durable PC response in patients with thrombocytopenia and CLD undergoing invasive procedures, with a safety profile similar to placebo.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Peck-Radosavljevic', 'Affiliation': 'Abteilung Innere Medizin & Gastroenterologie, mit Zentraler Aufnahme & Erstversorgung, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Simon', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Gastroenterology, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Hassanein', 'Affiliation': 'Southern California Research Center, Coronado, CA.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, University of California, Riverside, Rialto, CA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'Institut national de la santé et la recherche médicale (INSERM), Unit 1065, Centre Méditerranéen de Médecine Moléculaire (C3M), Team 8: ""Chronic liver diseases associated with obesity and alcohol"", Nice, France.'}, {'ForeName': 'Mihaly', 'Initials': 'M', 'LastName': 'Makara', 'Affiliation': 'Dél-pesti Centrumkórház-Országos Hematológiai és Infektológiai Intézet, Budapest, Hungary.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Ben Ari', 'Affiliation': 'Liver Disease Center, Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': 'Department of Gastroenterology, Rabin Medical Center Belinson Campus, Petah-Tikva, Israel.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mitrut', 'Affiliation': 'Spitalul Clinic Judetean de Urgenta Craiova, Craiova, Romania.'}, {'ForeName': 'Sheng-Shun', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Division of Gastroenterology & Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Akdogan', 'Affiliation': 'Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Pirisi', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Shionogi Ltd., Holborn, London, United Kingdom.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Motomiya', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Tsutae', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Nezam', 'Initials': 'N', 'LastName': 'Afdhal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30561'] 1211,29134819,Web-Based Intervention to Improve Implantable Cardioverter Defibrillator Patients' Shock-Related Anxiety and Quality of Life: A Randomized Controlled Trial.,"In spite of its effectiveness, implantable cardioverter defibrillator (ICD) patients face psychological problems such as shock-related anxiety due to device shocks. The aim of this study was to evaluate whether a web-based intervention program for ICD patients would reduce shock-related anxiety and improve quality of life compared with usual care. This was a randomized controlled trial study including a total of 76 patients. Data were collected using Turkish versions of the Florida Shock Anxiety Scale and Short Form Health Survey (SF-36) at 0 (baseline), 3, and 6 months. Following intervention, there was a significant decrease in shock anxiety levels of patients and a statistically significant increase in social functioning, role-physical, mental health, vitality, and bodily pain subdimensions of SF-36. While no statistically significant difference was found between groups in terms of summary scores of SF-36, our results suggest that web-based interventions can be useful for ICD patients.",2019,"Following intervention, there was a significant decrease in shock anxiety levels of patients and a statistically significant increase in social functioning, role-physical, mental health, vitality, and bodily pain subdimensions of SF-36.","['ICD patients', 'a total of 76 patients']",['implantable cardioverter defibrillator (ICD'],"['social functioning, role-physical, mental health, vitality, and bodily pain subdimensions of SF-36', 'Anxiety and Quality of Life', 'Florida Shock Anxiety Scale and Short Form Health Survey (SF-36', 'shock anxiety levels', 'shock-related anxiety and improve quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",76.0,0.103682,"Following intervention, there was a significant decrease in shock anxiety levels of patients and a statistically significant increase in social functioning, role-physical, mental health, vitality, and bodily pain subdimensions of SF-36.","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Yardımcı', 'Affiliation': '1 Sinop University School of Health, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Mert', 'Affiliation': '2 Dokuz Eylül University Faculty of Nursing, Izmir, Turkey.'}]",Clinical nursing research,['10.1177/1054773817741427'] 1212,29217375,"Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials.","BACKGROUND A safe, effective, and rapidly scalable vaccine against Zika virus infection is needed. We developed a purified formalin-inactivated Zika virus vaccine (ZPIV) candidate that showed protection in mice and non-human primates against viraemia after Zika virus challenge. Here we present the preliminary results in human beings. METHODS We did three phase 1, placebo-controlled, double-blind trials of ZPIV with aluminium hydroxide adjuvant. In all three studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA. Vaccinations were given intramuscularly on days 1 and 29. The primary objective was safety and immunogenicity of the ZPIV candidate. We recorded adverse events and Zika virus envelope microneutralisation titres up to day 57. These trials are registered at ClinicalTrials.gov, numbers NCT02963909, NCT02952833, and NCT02937233. FINDINGS We enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017. One was excluded and 67 participants received two injections of Zika vaccine (n=55) or placebo (n=12). The vaccine caused only mild to moderate adverse events. The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]). By day 57, 52 (92%) of vaccine recipients had seroconverted (microneutralisation titre ≥1:10), with peak geometric mean titres seen at day 43 and exceeding protective thresholds seen in animal studies. INTERPRETATION The ZPIV candidate was well tolerated and elicited robust neutralising antibody titres in healthy adults. FUNDING Departments of the Army and Defense and National Institute of Allergy and Infectious Diseases.",2018,"The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]).","['We enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017', 'healthy adults', 'human beings']","['placebo', 'purified formalin-inactivated Zika virus vaccine (ZPIV', 'Zika vaccine', 'ZPIV with aluminium hydroxide adjuvant', 'computer-generated list to receive 5 μg ZPIV or saline placebo']","['tenderness', 'adverse events and Zika virus envelope microneutralisation titres', 'malaise', 'headache', 'safety and immunogenicity']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",68.0,0.549153,"The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]).","[{'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'George', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA; Saint Louis VA Medical Center, Saint Louis, MO, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sondergaard', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tennant', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Barrett', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Kosel', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center and Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Meyer', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brien', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Crowell', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Blazevic', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Mosby', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Larocca', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abbink', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Bricault', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Basil', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tonwe', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hoft', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA; Saint Louis VA Medical Center, Saint Louis, MO, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA. Electronic address: nelson.l.michael2.mil@mail.mil.'}]","Lancet (London, England)",['10.1016/S0140-6736(17)33106-9'] 1213,31693429,Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.,"PURPOSE Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) fare poorly, with limited treatment options. The antibody-drug conjugate polatuzumab vedotin targets CD79b, a B-cell receptor component. METHODS Safety and efficacy of polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG) was evaluated in a single-arm cohort. Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR) was compared with bendamustine and rituximab (BR) in a randomly assigned cohort of patients with transplantation-ineligible R/R DLBCL (primary end point: independent review committee [IRC] assessed complete response [CR] rate at the end of treatment). Duration of response, progression-free survival (PFS), and overall survival (OS) were analyzed using Kaplan-Meier and Cox regression methods. RESULTS Pola-BG and pola-BR had a tolerable safety profile. The phase Ib/II pola-BG cohort (n = 27) had a CR rate of 29.6% and a median OS of 10.8 months (median follow-up, 27.0 months). In the randomly assigned cohort (n = 80; 40 per arm), pola-BR patients had a significantly higher IRC-assessed CR rate (40.0% v 17.5%; P = .026) and longer IRC-assessed PFS (median, 9.5 v 3.7 months; hazard ratio [HR], 0.36, 95% CI, 0.21 to 0.63; P < .001) and OS (median, 12.4 v 4.7 months; HR, 0.42; 95% CI, 0.24 to 0.75; P = .002; median follow-up, 22.3 months). Pola-BR patients had higher rates of grade 3-4 neutropenia (46.2% v 33.3%), anemia (28.2% v 17.9%), and thrombocytopenia (41% v 23.1%), but similar grade 3-4 infections (23.1% v 20.5%), versus the BR group. Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients. CONCLUSION Polatuzumab vedotin combined with BR resulted in a significantly higher CR rate and reduced the risk of death by 58% compared with BR in patients with transplantation-ineligible R/R DLBCL.",2020,"Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients. ","['patients with transplantation-ineligible R/R DLBCL (primary end point', 'Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL']","['polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG', 'Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR', 'bendamustine and rituximab (BR']","['risk of death', 'complete response [CR] rate', 'rates of grade 3-4 neutropenia', 'longer IRC-assessed PFS', 'anemia', 'CR rate', 'Duration of response, progression-free survival (PFS), and overall survival (OS', 'tolerable safety profile', 'IRC-assessed CR rate', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4078806', 'cui_str': 'polatuzumab vedotin'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",,0.250087,"Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients. ","[{'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alex F', 'Initials': 'AF', 'LastName': 'Herrera', 'Affiliation': 'City of Hope, Duarte, CA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Manali K', 'Initials': 'MK', 'LastName': 'Kamdar', 'Affiliation': 'University of Colorado, Aurora, CO.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': 'Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hertzberg', 'Affiliation': 'Prince of Wales Hospital and University of NSW, Sydney, NSW, Australia.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Assouline', 'Affiliation': 'Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Elicia', 'Initials': 'E', 'LastName': 'Penuel', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Paulson', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'F. Hoffman-La Roche, Mississauga, Ontario, Canada.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ku', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00172'] 1214,30737183,Effects of suvorexant on sleep apnea in patients with heart failure: A protocol of crossover pilot trial.,"BACKGROUND Suvorexant, an orexin receptor antagonist, is known as a safe and effective sleep medication. Many patients with heart failure (HF) have sleep-disordered breathing (SDB) and are short sleepers, and it is unknown whether suvorexant is effective in HF patients and can improve insomnia safely. The aim of this study is to examine the effect of suvorexant on SDB in patients with HF. METHODS The Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial) is a multicenter trial with a randomized double crossover design. We will enroll a total of 30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital. Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order. Before the study night, patients in the suvorexant first group will receive suvorexant for 4 consecutive days. There are at least 3 wash-out days between the study nights with and without suvorexant. Primary outcome measures of the non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB, and the results will be compared between the study nights with and without suvorexant. CONCLUSION The present study can determine whether suvorexant can be used in HF patients without affecting their SDB. This is a pilot study to primarily assess whether suvorexant affects the severity of SDB in patients with HF. Therefore, further study is warranted to investigate whether suvorexant alters short- and long-term clinical outcomes by providing longer and better sleep in patients with HF.",2019,Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order.,"['Many patients with heart failure (HF', 'patients with HF.\nMETHODS\n\n\nThe Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial', 'patients with heart failure', 'Eligible patients will undergo', 'patients with HF', 'HF patients without affecting their SDB', '30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital']","['portable sleep monitoring twice with or without oral administration of suvorexant', 'suvorexant']","['sleep apnea', 'non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0001563', 'cui_str': 'Drug Administration, Oral'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",30.0,0.0926004,Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shitara', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sleep and Sleep Disordered Breathing Center, Juntendo University Hospital, Tokyo, Japan. Electronic address: kasai-t@mx6.nisiq.net.'}, {'ForeName': 'Sato', 'Initials': 'S', 'LastName': 'Akihiro', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Yatsu', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Suda', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Ogita', 'Affiliation': 'Department of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Yanagisawa', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Fujibayashi', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Nojiri', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Nishizaki', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Ono', 'Affiliation': 'Faculty of International Liberal Arts, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Suwa', 'Affiliation': 'Department of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daida', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2018.12.021'] 1215,31557067,Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node.,"PURPOSE We have previously reported on the 3-year results of the phase III German Dermatologic Cooperative Oncology Group trial (DeCOG; ClinicalTrials.gov identifier: NCT02434107) comparing distant metastasis-free survival (DMFS), recurrence-free survival (RFS), and overall survival (OS) in patients with positive sentinel lymph-node biopsy who were randomly assigned to complete lymph node dissection (CLND) or observation. Here, we report the final analysis with 72 months of median follow up. PATIENTS AND METHODS The multicenter randomized phase III trial included patients with cutaneous melanoma of the trunk and extremities who were randomly assigned (1:1) to undergo CLND or observation. DMFS was analyzed as the primary end point, and RFS, OS, and recurrences in the regional lymph node basin were secondary end points. The analysis was by intention to treat. Disease and survival information were collected quarterly. RESULTS From January 2006 to December 2014, 5,547 patients were screened to identify 1,256 with metastases in the sentinel lymph node (SLN). Of these, 483 (39%) were included: 241 in the observation arm and 242 in the CLND arm. In the final analysis, median follow up was 72 months (interquartile range, 67-77 months). No significant treatment-related difference was seen in the 5-year DMFS between the observation and CLND arms (67.6% v 64.9%, respectively; hazard ratio [HR], 1.08; P = .87). The 5-year RFS and OS also showed no difference (HR, 1.01 and 0.99, respectively). Grade 3 and 4 adverse effects occurred in 32 patients (13%) in the CLND arm; lymphedema (n = 20) and delayed wound healing (n = 5) were most common and no serious adverse events were reported. CONCLUSION The final results of the German Dermatologic Cooperative Oncology Group trial with a median follow up of 72 months showed higher event rates, but similar HRs compared with those at the 3-year analysis. These results confirm that immediate CLND in SLN-positive patients is not superior to observation in terms of DMFS, RFS, or OS and support not recommending CLND in patients with SLN metastasis.",2019,"These results confirm that immediate CLND in SLN-positive patients is not superior to observation in terms of DMFS, RFS, or OS and support not recommending CLND in patients with SLN metastasis.","['From January 2006 to December 2014, 5,547 patients were screened to identify 1,256 with metastases in the sentinel lymph node (SLN', 'Patients With Melanoma', 'patients with positive sentinel lymph-node biopsy', '483 (39%) were included: 241 in the observation arm and 242 in the CLND arm', 'patients with SLN metastasis', 'patients with cutaneous melanoma of the trunk and extremities who were randomly assigned (1:1) to undergo']","['CLND or observation', 'complete lymph node dissection (CLND) or observation']","['DMFS', '5-year RFS and OS', 'distant metastasis-free survival (DMFS), recurrence-free survival (RFS), and overall survival (OS', 'delayed wound healing', 'Grade 3 and 4 adverse effects', 'Disease and survival information', '5-year DMFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",5547.0,0.306993,"These results confirm that immediate CLND in SLN-positive patients is not superior to observation in terms of DMFS, RFS, or OS and support not recommending CLND in patients with SLN metastasis.","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Leiter', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Stadler', 'Affiliation': 'Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Mauch', 'Affiliation': 'University of Köln/Bonn, Cologne, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Norbert H', 'Initials': 'NH', 'LastName': 'Brockmeyer', 'Affiliation': 'Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Berking', 'Affiliation': 'Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Cord', 'Initials': 'C', 'LastName': 'Sunderkötter', 'Affiliation': 'University of Munster, Munster, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaatz', 'Affiliation': 'SRH Wald-Klinikum Gera, Gera, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schatton', 'Affiliation': 'University of Düsseldorf, Dusseldorf, Germany.'}, {'ForeName': 'Percy', 'Initials': 'P', 'LastName': 'Lehmann', 'Affiliation': 'HELIOS-Klinikum Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vogt', 'Affiliation': 'University of Homburg, Homburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ulrich', 'Affiliation': 'University of Magdeburg, Quedlinburg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Herbst', 'Affiliation': 'HELIOS-Klinikum Erfurt, Erfurt, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gehring', 'Affiliation': 'Carl Von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Jan-Christoph', 'Initials': 'JC', 'LastName': 'Simon', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Keim', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Verver', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02306'] 1216,31697244,A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial.,"BACKGROUND Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. OBJECTIVE This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. METHODS Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (t 1 ), midintervention (t 4 =4 weeks after t 1 ) and postintervention (t 8 =8 weeks after t 1 ). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. RESULTS Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete t 4 and t 8 assessments were equally distributed between groups (t 4 : control group=34.6% [83/240] and intervention group=40.8% [102/250]; P=.16; t 8 : control group=29.9% [47/157] and intervention group=21.6% [32/148]; P=.10). Both groups showed a significant increase in general well-being as a function of time (F 2,426 =5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F 2,426 =8.92; P<.001), as well as a significant reduction in work-related and overall stress (F 2,426 =5.50; P=.004 and F 2,426 =8.59; P<.001, respectively). CONCLUSIONS The well-being mobile app was effective in reducing employee stress and improving well-being. TRIAL REGISTRATION Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.",2019,"Both groups showed a significant increase in general well-being as a function of time (F 2,426 =5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F 2,426 =8.92; P<.001), as well as a significant reduction in work-related and overall stress (F 2,426 =5.50; P=.004 and F 2,426 =8.59; P<.001, respectively). ","['653 individuals self-enrolled through the website', 'Working Women', 'Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads', 'randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol', 'Eligible participants were randomized between control (n=240) and intervention (n=250) groups']",[],"['employee stress and improving well-being', 'conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization', 'general well-being as a function of time', 'work-related and overall stress']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043215', 'cui_str': 'Women, Working'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600191', 'cui_str': 'Intranets'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",185.0,0.0876708,"Both groups showed a significant increase in general well-being as a function of time (F 2,426 =5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F 2,426 =8.92; P<.001), as well as a significant reduction in work-related and overall stress (F 2,426 =5.50; P=.004 and F 2,426 =8.59; P<.001, respectively). ","[{'ForeName': 'Cássia Canha', 'Initials': 'CC', 'LastName': 'Coelhoso', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Patricia Renovato', 'Initials': 'PR', 'LastName': 'Tobo', 'Affiliation': 'Natura Cosméticos SA, Cajamar, Brazil.'}, {'ForeName': 'Shirley Silva', 'Initials': 'SS', 'LastName': 'Lacerda', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Alex Heitor', 'Initials': 'AH', 'LastName': 'Lima', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Carla Regina Camara', 'Initials': 'CRC', 'LastName': 'Barrichello', 'Affiliation': 'Natura Cosméticos SA, Cajamar, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Elisa Harumi', 'Initials': 'EH', 'LastName': 'Kozasa', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}]",Journal of medical Internet research,['10.2196/14269'] 1217,31550051,Developing efficient and effective behavioral treatment for insomnia in cancer survivors: Results of a stepped care trial.,"BACKGROUND Insomnia is common among cancer survivors. Although behavioral treatments for insomnia are effective, access is limited. Stepped care delivery models may provide insomnia treatment that is more efficient and accessible to cancer survivors. METHODS Fifty-one survivors (mean age, 55 years) with elevated Insomnia Severity Index (ISI) scores (≥12) first participated in Sleep Training Education Program (STEP)-1: a single, sleep education session. Those reporting elevated ISI scores 1 month later were offered STEP-2: a 3-session, group cognitive behavioral treatment for insomnia that has been demonstrated to be efficacious. Participants were considered treatment responders if their ISI score improved by ≥6 points and were considered as having remitted if their posttreatment ISI score was <12. Mood was assessed with the Profile of Mood States-Short Form (POMS-SF). RESULTS Following STEP-1, ISI scores improved (17.1 to 11.2; P < .001), with 45% responding and 41% remitted. Insomnia remission after STEP-1 was associated with lower insomnia severity and shorter duration of sleep problems at baseline. Of the 30 (59%) survivors with unremitted insomnia after STEP-1, 14 (47%) participated in STEP-2. Following STEP-2, ISI scores improved (16.9 to 8.8; P < .001), with 79% responding and 71% remitted. STEP-2 participation was associated with interest in sleep treatment at baseline, but not demographic/health-related variables. Mood improved significantly following both STEP-1 and STEP-2 (P < .001). CONCLUSION A stepped care approach to treating insomnia among cancer survivors has the potential to improve treatment accessibility. A sizable proportion of survivors can benefit from 2 different low-intensity approaches that could be delivered by nonsleep specialists. For individuals who require more intensive care, assessing treatment interest can identify those who are likely to engage.",2020,Mood improved significantly following both STEP-1 and STEP-2,"['Fifty-one survivors (mean age, 55\xa0years) with elevated Insomnia Severity Index (ISI) scores (≥12) first participated in', 'cancer survivors']","['STEP-1 and STEP-2', 'Sleep Training Education Program (STEP)-1: a single, sleep education session']","['ISI score', 'Insomnia remission', 'insomnia severity and shorter duration of sleep problems', 'ISI scores']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4706228', 'cui_str': 'Insomnia Severity Index score (observable entity)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C1301776', 'cui_str': 'Step 1'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]",51.0,0.0672453,Mood improved significantly following both STEP-1 and STEP-2,"[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Zhou', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Alexis L', 'Initials': 'AL', 'LastName': 'Michaud', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Recklitis', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts.""}]",Cancer,['10.1002/cncr.32509'] 1218,30735015,Proportional assist ventilation feasibility in the early stage of respiratory failure: a prospective randomized multicenter trial.,"BACKGROUND Proportional assist ventilation (PAV+) is an assisted ventilator mode usually applied during weaning. We aimed to determine the feasibility of using PAV+ in the early phase of acute respiratory failure compared to volume-assist control ventilation (V-ACV) in order to shorten the length of mechanical ventilation (MV). METHODS We conducted a prospective randomized trial comparing high-assistance PAV+ (gain 80%) vs. V-ACV in four university hospital Intensive Care Units. Patients were included based on a previous pilot trial. Length of MV was the main objective. Secondary objectives were length of stay (LOS) in ICU/hospital, and ICU/hospital/60-day mortality. Statistics - Mann-Whitney U Test and Fisher's Exact Test. RESULTS We could not find differences in length of MV or any of the analyzed variables between the 52 patients with PAV+ and 50 patients with V-ACV. The high PAV+ failure rate (42%) was attributed to excessive sedation, high respiratory rate, and high respiratory effort. CONCLUSIONS The use of high-assistance PAV+ in the early phase of MV does not present benefits compared to V-ACV. The high rate of PAV+ failure reinforces the need for sedative optimization, learning curve, and better patient selection.",2019,We could not find differences in length of MV or any of the analyzed variables between the 52 patients with PAV+ and 50 patients with V-ACV.,"['4 university hospital intensive care units', '52 patients with PAV+ and 50 patients with V-ACV', 'early stage of respiratory failure']","['high-assistance PAV+ (gain 80%) vs. V-ACV', 'Proportional assist ventilation (PAV', 'volume-assist control ventilation (V-ACV', 'PAV']","['high PAV+ failure rate', 'length of MV', 'length of mechanical ventilation (MV', 'Length of MV', 'length of stay (LOS) in ICU/hospital, and ICU/hospital/60-day mortality']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231959', 'cui_str': 'Airway closing volume, function (observable entity)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0231959', 'cui_str': 'Airway closing volume, function (observable entity)'}, {'cui': 'C3178855', 'cui_str': 'Proportional Assist Ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0419014', 'cui_str': 'Assisted controlled mandatory ventilation (procedure)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.171603,We could not find differences in length of MV or any of the analyzed variables between the 52 patients with PAV+ and 50 patients with V-ACV.,"[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Delgado', 'Affiliation': 'Department of Anesthesiology, Intensive Care Unit, Bürgerspital Solothurn, Solothurn, Switzerland - marcosdelgado1976@gmail.com.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Subirá', 'Affiliation': 'Intensive Care Unit, Hospital Sant Joan de Deu, Althaia Xarxa Assistencial, Manresa, Spain.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Hermosa', 'Affiliation': 'Intensive Care Unit, University Hospital of Henares, Coslada, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Gordo', 'Affiliation': 'Intensive Care Unit, University Hospital of Henares, Coslada, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Riera', 'Affiliation': ""Intensive Care Unit, Hospital of Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fernández', 'Affiliation': 'Intensive Care Unit, Hospital Sant Joan de Deu, Althaia Xarxa Assistencial, Manresa, Spain.'}]",Minerva anestesiologica,['10.23736/S0375-9393.19.12618-1'] 1219,30204734,Effect of Vitamin D Deficiency on Hypertrophic Scarring.,"BACKGROUND Although many different diseases have been reported with vitamin D deficiency, the authors failed to find any studies on the association of hypertrophic scarring (HS) in the literature. OBJECTIVE The authors aimed to determine the relationship between vitamin D deficiency and HS and investigate the effect of replacement therapy on HS development in patients with vitamin D deficiency. PATIENTS AND METHODS Patients who presented to the authors' outpatient clinic with HS between 2013 and 2016 were included in the study. In the first stage, all the patients with HS complaints were assessed for vitamin D levels. In the second stage, 50 patients with a vitamin D level less than 25 ng/mL and a linear scar after at least 1 year of trauma were randomly divided into 3 groups. Group 1: patients who did not accept any medical or surgical treatment; Group 2: patients who were subjected to vitamin D replacement only; Group 3: patients who underwent surgical excision and suturation after vitamin D replacement. RESULTS A statistically significant correlation was found between HS and vitamin D levels (p < .05). A statistically significant decrease in scar width was observed in Group 3 (p < .05). CONCLUSION Increasing vitamin D levels to above 25 ng/mL before scar revision and vitamin D deficiency in patients with HS may help reduce scar width.",2019,"A statistically significant decrease in scar width was observed in Group 3 (p < .05). ","['Hypertrophic Scarring', '50 patients with a vitamin D level less than 25 ng/mL and a linear scar after at least 1 year of trauma', 'patients with vitamin D deficiency', ""Patients who presented to the authors' outpatient clinic with HS between 2013 and 2016 were included in the study"", 'Group 1: patients who did not accept any medical or surgical treatment; Group 2: patients who were subjected to']","['vitamin D replacement', 'Vitamin D Deficiency', 'replacement therapy', 'surgical excision and suturation after vitamin D replacement']","['HS and vitamin D levels', 'vitamin D levels', 'scar width']","[{'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",50.0,0.0570305,"A statistically significant decrease in scar width was observed in Group 3 (p < .05). ","[{'ForeName': 'Bilsev', 'Initials': 'B', 'LastName': 'Ince', 'Affiliation': '*All authors are affiliated with the Department of Plastic, Reconstructive and Aesthetic Surgery, Meram Faculty of Medicine, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Uyar', 'Affiliation': ''}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Dadaci', 'Affiliation': 'All authors are affiliated with the Department of Plastic, Reconstructive and Aesthetic Surgery, Meram Faculty of Medicine, Necmettin Erbakan University, Konya, Turkey.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001680'] 1220,30269534,Implementing e-learning and e-tools for care home staff supporting residents with dementia and challenging behaviour: A process evaluation of the ResCare study using normalisation process theory.,"Dementia-related symptoms, sometimes termed challenging or distressing behaviour, can give rise to significant distress in care homes. Individualised formulation-led interventions show promise in reducing these behaviours. ResCare, a cluster randomised controlled trial in England, tested an online individualised intervention, comprising e-learning and decision support e-tools, designed to enable staff to better support residents with such symptoms. Normalisation process theory was used to understand the implementation processes. We analysed contextual process data for all 27 'intervention' care homes and identified three implementation mechanisms. These were examined for four illustrative case study homes. Seven qualitative interviews with care home staff and one interview with two research therapists informed this understanding. The main barrier to implementation was difficulty in conveying a sustained understanding of the value of individually tailored interventions. Emphasis was placed on training rather than practice change. Implementation seemed easier in smaller homes and in those with flexible managerial styles where transfer of knowledge and skill might have been easier to achieve. Take up of e-learning and e-tools proved hard. There may be a need to continually promote 'buy-in' of the potential benefits of individualised formulation-led interventions, and this would have to be congruent with other priorities. Interventions within care homes need to consider organisational readiness, capacity for innovation and ongoing appraisal and adjustment to maintain changes in practice.",2020,Implementation seemed easier in smaller homes and in those with flexible managerial styles where transfer of knowledge and skill might have been easier to achieve.,"['care home staff supporting residents with dementia and challenging behaviour', ""all 27 'intervention' care homes and identified three implementation mechanisms""]",[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0474414', 'cui_str': 'Challenging behavior (finding)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}]",[],[],,0.0272904,Implementation seemed easier in smaller homes and in those with flexible managerial styles where transfer of knowledge and skill might have been easier to achieve.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Keenan', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Manthorpe', 'Affiliation': ""Social Care Workforce Research Unit, King's College London, UK.""}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Hart', 'Affiliation': 'R&D Department, Humber NHS Foundation Trust, UK.'}, {'ForeName': 'Esme', 'Initials': 'E', 'LastName': 'Moniz-Cook', 'Affiliation': 'Faculty of Health Sciences, School of Health and Social Care, University of Hull, UK.'}]","Dementia (London, England)",['10.1177/1471301218803195'] 1221,31475572,Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes.,"BACKGROUND The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol ≥70 mg/dL or non-high-density lipoprotein cholesterol ≥100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. METHODS In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. RESULTS Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; P interaction =0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; P interaction =0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P interaction =0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P interaction =0.661). CONCLUSIONS The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402.",2019,"The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P interaction =0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P interaction =0.661). ","['Of 18\u2009924 participants followed for a median of 2.8 years, 11\u2009935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions', 'patients with low-density lipoprotein cholesterol ≥70', 'Acute Coronary Syndromes', 'patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy', 'patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events']","['lipid-lowering therapies', 'placebo', 'Alirocumab', 'mg/dL or non-high-density lipoprotein cholesterol ≥100', 'alirocumab or placebo']","['absolute risk reduction for major adverse cardiovascular events with alirocumab', 'American College of Cardiology/American Heart Association risk category', 'adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina', 'Major adverse cardiovascular events', 'adverse cardiovascular events']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}]","[{'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}]",,0.0447947,"The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P interaction =0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P interaction =0.661). ","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (M.T.R., R.D.L.).'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY (Q.H.L., M.J.L.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (D.L.B.).""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'University of Alabama at Birmingham (V.A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Argentina (R.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St Michael's Hospital, Toronto, Canada (S.G.G.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford University Medical Center, CA (R.A.H.).'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Leiden University Medical Center, the Netherlands (J.W.J.).'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Fundación Oftalmológica de Santander (FOSCAL), Medical School (UDES), Floridablanca, Colombia (P.L.-J.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (M.T.R., R.D.L.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY (Q.H.L., M.J.L.).'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'University of Kansas Medical Center, Kansas City, MO (P.M.M.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York (SUNY) Downstate Medical Center, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vogel', 'Affiliation': 'University of Colorado, Aurora (R.V., G.G.S.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, New Zealand (H.D.W.).'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany (A.M.Z.).'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi, Montpellier, France (M.T.B.-D.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), Institut National de la Santé et de la Recherche Médicale (INSERM) U1148, France (P.G.S.).'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'University of Colorado, Aurora (R.V., G.G.S.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042551'] 1222,32407786,Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine.,"BACKGROUND Surgical site infections after cesarean delivery are a cause of maternal morbidity and are typically caused by skin microbial flora. Preadmission application of chlorhexidine gluconate using impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora. OBJECTIVE To determine whether the application of chlorhexidine gluconate cloths the night before and the morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks postoperatively compared with placebo. STUDY DESIGN In this single-center, double-blind, placebo-controlled trial, patients were randomized (1:1) to receive either Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo) to apply to 6 skin sites on the body (neck, shoulders and chest, armpits, arm and hands, abdomen and groin, left leg and foot, right leg and foot, back and buttocks) the night before and after a shower the morning of scheduled cesarean delivery. Routine clinical and operative procedures were followed. The primary outcome was surgical site infections (superficial or deep incisional with or without organ space endometritis) by 6 weeks after cesarean delivery. The secondary outcomes were surgical site infections by 2 weeks and other wound-related complications by 2 and 6 weeks after cesarean delivery. RESULTS From April 2015 to August 2019, 1356 patients were enrolled: 682 were assigned to the chlorhexidine group and 674 to the placebo group. The groups were similar in demographic and medical characteristics. A total of 14 patients were lost to follow-up before cesarean delivery (10 in chlorhexidine and 4 in placebo) and 33 were lost to follow-up after cesarean delivery (10 in chlorhexidine and 23 in placebo). Among the remaining 1309 (97%), no difference was found in surgical site infections by 6 weeks between the 2 groups (2.6% in chlorhexidine vs 3.7% in placebo; P=.24). There were no differences in secondary outcomes at 2 or 6 weeks and no differences in primary outcome in a per-protocol analysis. CONCLUSION Preadmission use of chlorhexidine gluconate cloths compared with placebo does not reduce the risk of surgical site infection after scheduled cesarean deliveries. Following the standard of care guidelines results in a low risk of surgical site infections in this group of patients.",2020,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"['1,356 patients were enrolled: 682', 'From April 2015 through August 2019', 'Prior to Elective Cesarean Deliveries (STRIPES', 'Fourteen patients were lost to follow-up prior to cesarean delivery (10 in']","['chlorhexidine gluconate-impregnated cloths', 'chlorhexidine and 23 in placebo', 'chlorhexidine', 'Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo', 'chlorhexidine gluconate', 'chlorhexidine and 4 in placebo', 'placebo']","['risk of surgical site infections', 'surgical site infection', 'surgical site infections (superficial or deep -incisional and/or organ space-endometritis', 'surgical site infections by 2 weeks and other wound-related complications', 'Infection', 'surgical site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1532935', 'cui_str': 'Striped'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0031000', 'cui_str': 'Perfume'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",1356.0,0.327365,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: joanne.stone@mssm.edu.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Monro', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overybey', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cadet', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Katie Hyewon', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pena', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Robles', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Mella', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kathy C', 'Initials': 'KC', 'LastName': 'Matthews', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Factor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.021'] 1223,31685304,Gentle facemask ventilation during induction of anesthesia.,"BACKGROUND To determine the level of inspiratory pressure minimizing the risk of gastric insufflation while providing adequate pulmonary ventilation. METHODS In this prospective, randomized, double-blind study, patients were allocated to one of the two groups (P10, P15) defined by the inspiratory pressure applied during controlled-pressure ventilation: 10 and 15 cm H 2 O. Anesthesia was induced using propofol and sufentanil; no neuromuscular-blocking agent was administered. Once loss of eyelash reflex occurred, facemask ventilation was started for a 2-min period. The cross-sectional antral area was measured using ultrasonography before and after facemask ventilation. Respiratory parameters were recorded. RESULTS Forty patients were analyzed. Mean tidal volume was about 7 ml/kg in group P10, and was >11 ml/kg in group P15 in the same period. As indicated by ultrasonography test, the antral area in P15 group was markedly incresed compared with P10 group. CONCLUSION Inspiratory pressure of 10 cm H 2 O allowed for reduced occurrence of gastric insufflation with proper lung ventilation during induction of anesthesia with sufentanil and propofol in nonparalyzed and nonobese patients.",2020,"As indicated by ultrasonography test, the antral area in P15 group was markedly incresed compared with P10 group. ","['Forty patients were analyzed', 'nonparalyzed and nonobese patients']","['Gentle facemask ventilation', 'propofol and sufentanil; no neuromuscular-blocking agent', 'sufentanil and propofol']","['eyelash reflex', 'Inspiratory pressure', 'Mean tidal volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular Blockers'}]","[{'cui': 'C0422906', 'cui_str': 'Eyelash reflex (observable entity)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}]",40.0,0.0642312,"As indicated by ultrasonography test, the antral area in P15 group was markedly incresed compared with P10 group. ","[{'ForeName': 'Qingfu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.""}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.""}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China. Electronic address: zhangjunfeng16@126.com.""}, {'ForeName': 'Daqiang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China. Electronic address: daqiangzhao23@yeah.net.""}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158399'] 1224,31688194,Online Learning and Residents' Acquisition of Mechanical Ventilation Knowledge: Sequencing Matters.,"OBJECTIVE Rapid advancements in medicine and changing standards in medical education require new, efficient educational strategies. We investigated whether an online intervention could increase residents' knowledge and improve knowledge retention in mechanical ventilation when compared with a clinical rotation and whether the timing of intervention had an impact on overall knowledge gains. DESIGN A prospective, interventional crossover study conducted from October 2015 to December 2017. SETTING Multicenter study conducted in 33 PICUs across eight countries. SUBJECTS Pediatric categorical residents rotating through the PICU for the first time. We allocated 483 residents into two arms based on rotation date to use an online intervention either before or after the clinical rotation. INTERVENTIONS Residents completed an online virtual mechanical ventilation simulator either before or after a 1-month clinical rotation with a 2-month period between interventions. MEASUREMENTS AND MAIN RESULTS Performance on case-based, multiple-choice question tests before and after each intervention was used to quantify knowledge gains and knowledge retention. Initial knowledge gains in residents who completed the online intervention (average knowledge gain, 6.9%; SD, 18.2) were noninferior compared with those who completed 1 month of a clinical rotation (average knowledge gain, 6.1%; SD, 18.9; difference, 0.8%; 95% CI, -5.05 to 6.47; p = 0.81). Knowledge retention was greater following completion of the online intervention when compared with the clinical rotation when controlling for time (difference, 7.6%; 95% CI, 0.7-14.5; p = 0.03). When the online intervention was sequenced before (average knowledge gain, 14.6%; SD, 15.4) rather than after (average knowledge gain, 7.0%; SD, 19.1) the clinical rotation, residents had superior overall knowledge acquisition (difference, 7.6%; 95% CI, 2.01-12.97;p = 0.008). CONCLUSIONS Incorporating an interactive online educational intervention prior to a clinical rotation may offer a strategy to prime learners for the upcoming rotation, augmenting clinical learning in graduate medical education.",2020,"Initial knowledge gains in residents who completed the online intervention (average knowledge gain, 6.9%; SD, 18.2) were noninferior compared with those who completed 1 month of a clinical rotation (average knowledge gain, 6.1%; SD, 18.9; difference, 0.8%; 95% CI, -5.05 to 6.47; p = 0.81).","['Multicenter study conducted in 33 PICUs across eight countries', 'Pediatric categorical residents rotating through the PICU for the first time', 'from October 2015 to December 2017']","['Mechanical Ventilation Knowledge', 'Residents completed an online virtual mechanical ventilation simulator', 'interactive online educational intervention', 'online intervention']","['superior overall knowledge acquisition', 'Initial knowledge gains', 'Knowledge retention', 'knowledge gains and knowledge retention']","[{'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",483.0,0.070347,"Initial knowledge gains in residents who completed the online intervention (average knowledge gain, 6.9%; SD, 18.2) were noninferior compared with those who completed 1 month of a clinical rotation (average knowledge gain, 6.1%; SD, 18.9; difference, 0.8%; 95% CI, -5.05 to 6.47; p = 0.81).","[{'ForeName': 'Traci A', 'Initials': 'TA', 'LastName': 'Wolbrink', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Sandrijn M', 'Initials': 'SM', 'LastName': 'van Schaik', 'Affiliation': 'Division of Pediatric Critical Care Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Turner', 'Affiliation': ""Division of Pediatric Critical Care, Department of Pediatrics, Duke Children's Hospital, Durham, NC.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Staffa', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Keller', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Boyer', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chong', 'Affiliation': ""Division of Pediatric Critical Care, University of Chicago, Comer Children's Hospital, Chicago, IL.""}, {'ForeName': 'Jarrod', 'Initials': 'J', 'LastName': 'Cross', 'Affiliation': ""Paediatric Critical Care, Perth Children's Hospital, WA, Australia.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Del Castillo', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feng', 'Affiliation': 'Kapiolani Medical Center for Women and Children, Honolulu, HI.'}, {'ForeName': 'R Stanley', 'Initials': 'RS', 'LastName': 'Hum', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Ebor', 'Initials': 'E', 'LastName': 'Jacob James', 'Affiliation': 'Christian Medical College, Vellore, India.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': ""Division of Pediatric Critical Care Medicine, University of Massachusetts Children's Medical Center, Worcester, MA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kandil', 'Affiliation': 'Department of Pediatrics, Critical Care Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kneyber', 'Affiliation': ""Beatrix Children's Hospital, University Medical Center Groninger, University of Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Rameshkumar', 'Affiliation': 'Division of Pediatric Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': ""Division of Critical Care Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Muralidharan', 'Initials': 'M', 'LastName': 'Jayashree', 'Affiliation': 'Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Olivero', 'Affiliation': ""Helen DeVos Children's Hospital, Grand Rapids, MI.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Oberender', 'Affiliation': ""Pediatric Critical Care Medicine, Monash Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Rahul S', 'Initials': 'RS', 'LastName': 'Panesar', 'Affiliation': ""Stony Brook Children's Hospital, Stony Brook, NY.""}, {'ForeName': 'Puneet A', 'Initials': 'PA', 'LastName': 'Pooni', 'Affiliation': 'Dayanand Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Rehder', 'Affiliation': ""Division of Pediatric Critical Care, Department of Pediatrics, Duke Children's Hospital, Durham, NC.""}, {'ForeName': 'Shuba', 'Initials': 'S', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Pediatrics, Sri Ramachandra Medical College and Research Institute, Porur, Chennai, India.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Scheffler', 'Affiliation': ""Hasbro Children's Hospital, Providence, RI.""}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Sharara-Chami', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Siems', 'Affiliation': ""Division of Critical Care Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Rajakumar', 'Initials': 'R', 'LastName': 'Padur Sivaraman', 'Affiliation': ""Hasbro Children's Hospital, Providence, RI.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tegtmeyer', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Valentine', 'Affiliation': ""Division of Pediatric Critical Care Medicine, University of Massachusetts Children's Medical Center, Worcester, MA.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Villois', 'Affiliation': 'Garrahan Hospital, Buenas Aires, Argentina.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'von Saint Andre-von Arnim', 'Affiliation': ""Division of Pediatric Critical Care, Department of Pediatrics, Seattle Children's and University of Washington, Seattle, WA.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dede', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Burns', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004071'] 1225,31845316,The effect of intrathecal bupivacaine/morphine on quality of recovery in robot-assisted radical prostatectomy: a randomised controlled trial.,"Robot-assisted radical prostatectomy causes discomfort in the immediate postoperative period. This randomised controlled trial investigated if intrathecal bupivacaine/morphine, in addition to general anaesthesia, could be beneficial for the postoperative quality of recovery. One hundred and fifty-five patients were randomly allocated to an intervention group that received intrathecal 12.5 mg bupivacaine/300 μg morphine (20% dose reduction in patients > 75 years) or a control group receiving a subcutaneous sham injection and an intravenous loading dose of 0.1 mg.kg -1 morphine. Both groups received standardised general anaesthesia and the same postoperative analgesic regimen. The primary outcome was a decrease in the Quality of Recovery-15 (QoR-15) questionnaire score on postoperative day 1. The intervention group (n = 76) had less reduction in QoR-15 on postoperative day 1; median (IQR [range]) 10% (1-8 [-60% to 50%]) vs. 13% (5-24 [-6% to 50%]), p = 0.019, and used less morphine during the admission; 2 mg (1-7 [0-41 mg]) vs. 15 mg (12-20 [8-61 mg]), p < 0.001. Furthermore, they perceived lower pain scores during exertion; numeric rating scale (NRS) 3 (1-6 [0-9]) vs. 5 (3-7 [0-9]), p = 0.001; less bladder spasms (NRS 1 (0-2 [0-10]) vs. 2 (0-5 [0-10]), p = 0.001 and less sedation; NRS 2 (0-3 [0-10]) vs. 3 (2-6 [0-10]), p = 0.005. Moreover, the intervention group used less rescue medication. Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000. We conclude that despite a modest increase in the incidence of pruritus, multimodal pain management with intrathecal bupivacaine/morphine remains a viable option for robot-assisted radical prostatectomy.",2020,"Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000.","['One hundred and fifty-five patients', 'robot-assisted radical prostatectomy']","['control group receiving a subcutaneous sham injection and an intravenous loading dose of 0.1\xa0mg.kg -1 morphine', 'morphine', 'Robot-assisted radical prostatectomy', 'bupivacaine/morphine', 'standardised general anaesthesia', 'intrathecal 12.5\xa0mg bupivacaine/300\xa0μg morphine', 'intrathecal bupivacaine/morphine']","['Pruritus', 'bladder spasms', 'pain scores during exertion; numeric rating scale (NRS', 'Quality of Recovery-15 (QoR-15) questionnaire score', 'rescue medication', 'quality of recovery']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0426390', 'cui_str': 'Spasm of bladder (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",155.0,0.246728,"Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000.","[{'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Koning', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Vlieger', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'A J W', 'Initials': 'AJW', 'LastName': 'Teunissen', 'Affiliation': 'Department of Anaesthesiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gan', 'Affiliation': 'Department of Urology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Ruijgrok', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'de Graaff', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'J S H A', 'Initials': 'JSHA', 'LastName': 'Koopman', 'Affiliation': 'Department of Anaesthesiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Stolker', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}]",Anaesthesia,['10.1111/anae.14922'] 1226,31682542,Gefitinib Alone Versus Gefitinib Plus Chemotherapy for Non-Small-Cell Lung Cancer With Mutated Epidermal Growth Factor Receptor: NEJ009 Study.,"PURPOSE Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor combined with cytotoxic chemotherapy is highly effective for the treatment of advanced non-small-cell lung cancer (NSCLC) with EGFR mutations; however, little is known about the efficacy and safety of this combination compared with that of standard therapy with EGFR- tyrosine kinase inhibitors alone. METHODS We randomly assigned 345 patients with newly diagnosed metastatic NSCLC with EGFR mutations to gefitinib combined with carboplatin plus pemetrexed or gefitinib alone. Progression-free survival (PFS), PFS2, and overall survival (OS) were sequentially analyzed as primary end points according to a hierarchical sequential testing method. Secondary end points were objective response rate (ORR), safety, and quality of life. RESULTS The combination group demonstrated a better ORR and PFS than the gefitinib group (ORR, 84% v 67% [ P < .001]; PFS, 20.9 v 11.9 months; hazard ratio for death or disease progression, 0.490 [ P < .001]), although PFS2 was not significantly different (20.9 v 18.0 months; P = .092). Median OS in the combination group was also significantly longer than in the gefitinib group (50.9 v 38.8 months; hazard ratio for death, 0.722; P = .021). The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3% v 31.0%); there were no differences in quality of life. One treatment-related death was observed in the combination group. CONCLUSION Compared with gefitinib alone, gefitinib combined with carboplatin plus pemetrexed improved PFS in patients with untreated advanced NSCLC with EGFR mutations with an acceptable toxicity profile, although its OS benefit requires further validation.",2020,"The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3% v 31.0%); there were no differences in quality of life.","['345 patients with newly diagnosed metastatic NSCLC with EGFR mutations to gefitinib combined with', 'patients with untreated advanced NSCLC with EGFR mutations', 'advanced non-small-cell lung cancer (NSCLC) with EGFR mutations', 'Non-Small-Cell Lung Cancer']","['carboplatin plus pemetrexed or gefitinib alone', 'gefitinib alone, gefitinib combined with carboplatin plus pemetrexed', 'Gefitinib Alone Versus Gefitinib Plus Chemotherapy', 'cytotoxic chemotherapy']","['rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities', 'Progression-free survival (PFS), PFS2, and overall survival (OS', 'PFS', 'death', 'quality of life', 'objective response rate (ORR), safety, and quality of life', 'ORR and PFS', 'PFS2', 'hazard ratio for death or disease progression', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034380'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",345.0,0.0966276,"The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3% v 31.0%); there were no differences in quality of life.","[{'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Japan Community Health Care Organization Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Minato', 'Affiliation': 'Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Takamura', 'Affiliation': 'Obihiro Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Saitama Medical University, Hidaka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Tohoku University, Sendai, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Tohoku University School of Medicine, Sendai, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01488'] 1227,32407919,Application of a Microsurgical Space Restrictor in Microsurgical Simulation Training.,"OBJECTIVE To investigate the effect of the application of a microsurgical space restrictor in microsurgical simulation training. METHODS A microsurgical space restrictor that can restrict the operation space was designed and produced. Forty neurosurgery residents with standardized training were selected as the study subjects and were randomly divided into the experimental group (group A) and the control group (group B). Group A was trained using the space restrictor, and group B was trained using the traditional method. The skills and overall performance of the 2 groups of trainees were assessed by the Stanford Microsurgery and Resident Training (SMaRT) scale. The assessment was divided into 2 stages: the unobstructed microsurgery test, and the test with the microsurgical operation space restrictor. RESULTS In group A, the score for the first stage (A1) was 3.9 ± 0.6, the score for the second stage (A2) was 3.4 ± 0.6, and the score for A1 was better than that for A2 (P = 0.000); in group B, the score for the first stage (B1) was 3.57 ± 0.6, the score for the second stage (B2) was 3.0 ± 0.6, and the score for B1 was better than that for B2 (P = 0.000). Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009). CONCLUSIONS Microsurgical space restrictor use can improve the effect of microsurgical simulation training and help trainees better master microsurgical operation skills.",2020,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009). ",['Forty neurosurgery residents with standardized training were selected as the study subjects'],"['microsurgical simulation training', 'Microsurgical Space Restrictor']",['Stanford Microsurgery and Resident Training (SMaRT) scale'],"[{'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0137644,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009). ","[{'ForeName': 'Zuowei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China; Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Xingwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Fengzeng', 'Initials': 'F', 'LastName': 'Jian', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China. Electronic address: jianfengzeng@xwh.ccmu.edu.cn.""}]",World neurosurgery,['10.1016/j.wneu.2020.05.031'] 1228,30705500,Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial.,"IN BRIEF Hispanic patients with type 2 diabetes have poorer glycemic control and are at higher risk of severe diabetes complications and mortality than non-Hispanic white patients. This post hoc analysis investigated the safety and efficacy of insulin degludec versus insulin glargine 100 units/mL (glargine U100) in the Hispanic patient subpopulation from the SWITCH 2 trial. In Hispanic patients, hypoglycemia was consistently lower and nocturnal hypoglycemia was significantly lower with degludec versus glargine U100 at similar levels of glycemic control. Overall, results in Hispanic patients in SWITCH 2 were consistent with those in non-Hispanic patients.",2019,"In Hispanic patients, hypoglycemia was consistently lower and nocturnal hypoglycemia was significantly lower with degludec versus glargine U100 at similar levels of glycemic control.","['Hispanic patients with type 2 diabetes', 'Hispanic patient subpopulation from the SWITCH 2 trial', 'Hispanic Patients With Type 2 Diabetes', 'Hispanic patients']","['insulin degludec versus insulin glargine 100 units/mL (glargine U100', 'Insulin Degludec Versus Insulin Glargine U100']","['Hypoglycemia', 'hypoglycemia', 'nocturnal hypoglycemia']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia (disorder)'}]",,0.0319873,"In Hispanic patients, hypoglycemia was consistently lower and nocturnal hypoglycemia was significantly lower with degludec versus glargine U100 at similar levels of glycemic control.","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chaykin', 'Affiliation': 'Meridien Research, Bradenton, FL.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes and Endocrinology Research Center, Des Moines, IA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'de la Rosa', 'Affiliation': 'Paducah Endocrinology, Paducah, KY.'}, {'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Wysham', 'Affiliation': 'Rockwood Clinic, University of Washington, Spokane, WA.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nørgård Troelsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Signe H', 'Initials': 'SH', 'LastName': 'Østoft', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}]",Clinical diabetes : a publication of the American Diabetes Association,['10.2337/cd18-0016'] 1229,32107269,"Electroacupuncture for treatment-resistant insomnia: study protocol for a randomised, controlled, assessor-blinded, pilot clinical trial.","INTRODUCTION A considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia. METHODS AND ANALYSIS This is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment. ETHICS AND DISSEMINATION Ethical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference. TRIAL REGISTRATION NUMBER KCT0003235.",2020,The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7.,['Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months'],"['Electroacupuncture', 'usual care group will not receive EA treatment', 'EA', 'brochure containing educational information', 'electroacupuncture (EA', 'EA group or a usual care']","['mean change of the total score of the Insomnia Severity Index', 'quality of life', 'sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",50.0,0.115802,The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7.,"[{'ForeName': 'Jung-Hwa', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, Yangsan-si, Gyeongsanganm-do, Korea (the Republic of).'}, {'ForeName': 'Kyung-Ok', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Department of Oriental Neuropsychiatry, Dongshin University College of Korean Medicine, Gwangju, Korea (the Republic of).'}, {'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry of Korean Medicine, Pohang Korean Medicine Hospital, Daegu Haany University College of Oriental Medicine, Pohang-si, Gyeongsangbuk-do, Korea (the Republic of).'}, {'ForeName': 'Chang-Wan', 'Initials': 'CW', 'LastName': 'Kang', 'Affiliation': 'Division of Industrial Convergence System Engineering, Dong Eui University, Busan, Busan, Korea (the Republic of).'}, {'ForeName': 'Bo-Kyung', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, Yangsan-si, Gyeongsanganm-do, Korea (the Republic of) npjolie@hanmail.net.'}]",BMJ open,['10.1136/bmjopen-2019-034239'] 1230,29524005,The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England.,"BACKGROUND Nivolumab was the first programmed death receptor 1 (PD-1) immune checkpoint inhibitor to demonstrate long-term survival benefit in a clinical trial setting for advanced melanoma patients. OBJECTIVE To evaluate the cost effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England. METHODS A Markov state-transition model was developed to estimate the lifetime costs and benefits of nivolumab versus ipilimumab and dacarbazine for BRAF mutation-negative patients and versus ipilimumab, dabrafenib, and vemurafenib for BRAF mutation-positive patients. Covariate-adjusted parametric curves for time to progression, pre-progression survival, and post-progression survival were fitted based on patient-level data from two trials and long-term ipilimumab survival data. Indirect treatment comparisons between nivolumab, ipilimumab, and dacarbazine were informed by these covariate-adjusted parametric curves, controlling for differences in patient characteristics. Kaplan-Meier data from the literature were digitised and used to fit progression-free and overall survival curves for dabrafenib and vemurafenib. Patient utilities and resource use data were based on trial data or the literature. Patients are assumed to receive nivolumab until there is no further clinical benefit, assumed to be the first of progressive disease, unacceptable toxicity, or 2 years of treatment. RESULTS Nivolumab is the most cost-effective treatment option in BRAF mutation-negative and mutation-positive patients, with incremental cost-effectiveness ratios of £24,483 and £17,362 per quality-adjusted life year, respectively. The model results are most sensitive to assumptions regarding treatment duration for nivolumab and the parameters of the fitted parametric survival curves. CONCLUSIONS Nivolumab is a cost-effective treatment for advanced melanoma patients in England.",2018,"The model results are most sensitive to assumptions regarding treatment duration for nivolumab and the parameters of the fitted parametric survival curves. ","['BRAF mutation-positive patients', 'advanced melanoma patients in England', 'BRAF mutation-negative patients and versus', 'advanced melanoma patients']","['nivolumab monotherapy', 'ipilimumab, dabrafenib, and vemurafenib', 'nivolumab, ipilimumab, and dacarbazine', 'nivolumab versus ipilimumab and dacarbazine']","['Covariate-adjusted parametric curves for time to progression, pre-progression survival, and post-progression survival', 'cost effectiveness', 'cost-effectiveness']","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.256899,"The model results are most sensitive to assumptions regarding treatment duration for nivolumab and the parameters of the fitted parametric survival curves. ","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'BresMed Health Solutions, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK. ymeng@bresmed.com.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hertel', 'Affiliation': 'Bristol-Myers Squibb Pharmaceuticals, Uxbridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ellis', 'Affiliation': 'Bristol-Myers Squibb Pharmaceuticals, Uxbridge, UK.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Morais', 'Affiliation': 'Bristol-Myers Squibb Pharmaceuticals, Uxbridge, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Helen Johnson Consulting Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Philips', 'Affiliation': 'BresMed Health Solutions, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Roskell', 'Affiliation': 'BresMed Health Solutions, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'BresMed Health Solutions, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-018-0964-4'] 1231,20142410,Long-term follow-up after risk-adapted treatment in clinical stage 1 (CS1) nonseminomatous germ-cell testicular cancer (NSGCT) implementing adjuvant CVB chemotherapy. A SWENOTECA study.,"BACKGROUND To offer minimized risk-adapted adjuvant treatment on a community and nationwide basis for patients with clinical stage 1 (CS1) nonseminomatous germ-cell testicular cancer (NSGCT). The aim was to reduce the risk of relapse and thereby reducing the need of later salvage chemotherapy while maintaining a high cure rate. PATIENTS AND METHODS From July 1995 to January 1998, a total of 232 Swedish and Norwegian patients were treated for CS1 NSGCT. All were eligible for inclusion into one of two community-based multicenter Swedish and Norwegian Testicular Cancer Project (SWENOTECA) III studies. One study was a prospective randomized study for patients without vascular invasion in the testicular tumor (VASC-), evaluating the effect of one adjuvant course of cisplatin, vinblastine and bleomycin (CVB) compared with surveillance. The second study was a prospective study evaluating the effect of two adjuvant courses of CVB for VASC+ patients. RESULTS Due to slow accrual and emerging data on toxicity of CVB, the studies were prematurely closed for inclusion in 1998. Of the 232 CS1 patients treated during the study period, only 97 were included in the studies. As all remaining patients were managed according to the SWENOTECA III protocol, although not randomized, the data were pooled. At a median follow-up of 10.1 years, there have been 24 relapses. While one course of CVB to VASC- patients had limited effect on the relapse rate, two courses of adjuvant CVB reduced the relapse rate among VASC+ patients by >90%. Toxicity was high in patients administered adjuvant CVB as 24% of patients experienced grade 3 or 4 obstipation/ileus and 23% grade 3 or 4 infection. CONCLUSIONS There was no statistical difference in relapse rate between one course of adjuvant CVB and surveillance for VASC- NSGCT patients. Two courses of adjuvant CVB for VASC+ NSGCT patients reduced the relapse rate with >90% in comparison to the surveillance group. Toxicity was unacceptably high for all patients receiving CVB. Adjuvant CVB chemotherapy has no place in the treatment of CS1 NSGCT.",2010,There was no statistical difference in relapse rate between one course of adjuvant CVB and surveillance for VASC- NSGCT patients.,"['232 CS1 patients treated during the study period, only 97 were included in the studies', 'VASC+ patients', 'All were eligible for inclusion into one of two community-based multicenter Swedish and Norwegian Testicular Cancer Project (SWENOTECA', 'patients with clinical stage 1 (CS1) nonseminomatous germ-cell testicular cancer (NSGCT', 'patients without vascular invasion in the testicular tumor (VASC', 'From July 1995 to January 1998, a total of 232 Swedish and Norwegian patients']","['CVB', 'CS1 NSGCT', 'cisplatin, vinblastine and bleomycin (CVB', 'Adjuvant CVB chemotherapy', 'VASC+ NSGCT']","['risk of relapse', 'relapse rate', 'Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0153594', 'cui_str': 'Cancer of Testis'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0017471', 'cui_str': 'Germ-Line Cells'}, {'cui': 'C0039590', 'cui_str': 'Testis Neoplasms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",232.0,0.0350929,There was no statistical difference in relapse rate between one course of adjuvant CVB and surveillance for VASC- NSGCT patients.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tandstad', 'Affiliation': 'Department of Oncology, St Olavs University Hospital, Trondheim, Norway. Electronic address: torgrim.tandstad@stolav.no.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cohn-Cedermark', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dahl', 'Affiliation': 'Department of Oncology, Haukeland University Hospital and Section of Oncology, Institute of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Stierner', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Gothenburg.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cavallin-Stahl', 'Affiliation': 'Department of Oncology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Bremnes', 'Affiliation': 'Institute of Clinical Medicine, University of Tromsø.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Klepp', 'Affiliation': 'Department of Oncology, Ålesund Hospital, Ålesund, Norway.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq026'] 1232,20150572,Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL).,"BACKGROUND Bevacizumab, the anti-vascular endothelial growth factor agent, provides clinical benefit when combined with platinum-based chemotherapy in first-line advanced non-small-cell lung cancer. We report the final overall survival (OS) analysis from the phase III AVAiL trial. PATIENTS AND METHODS Patients (n = 1043) received cisplatin 80 mg/m(2) and gemcitabine 1250 mg/m(2) for up to six cycles plus bevacizumab 7.5 mg/kg (n = 345), bevacizumab 15 mg/kg (n = 351) or placebo (n = 347) every 3 weeks until progression. Primary end point was progression-free survival (PFS); OS was a secondary end point. RESULTS Significant PFS prolongation with bevacizumab compared with placebo was maintained with longer follow-up {hazard ratio (HR) [95% confidence interval (CI)] 0.75 (0.64-0.87), P = 0.0003 and 0.85 (0.73-1.00), P = 0.0456} for the 7.5 and 15 mg/kg groups, respectively. Median OS was >13 months in all treatment groups; nevertheless, OS was not significantly increased with bevacizumab [HR (95% CI) 0.93 (0.78-1.11), P = 0.420 and 1.03 (0.86-1.23), P = 0.761] for the 7.5 and 15 mg/kg groups, respectively, versus placebo. Most patients ( approximately 62%) received multiple lines of poststudy treatment. Updated safety results are consistent with those previously reported. CONCLUSIONS Final analysis of AVAiL confirms the efficacy of bevacizumab when combined with cisplatin-gemcitabine. The PFS benefit did not translate into a significant OS benefit, possibly due to high use of efficacious second-line therapies.",2010,"The PFS benefit did not translate into a significant OS benefit, possibly due to high use of efficacious second-line therapies.","['Patients (n = 1043) received', 'nonsquamous non-small-cell lung cancer']","['placebo', 'cisplatin 80 mg/m(2) and gemcitabine 1250 mg/m(2) for up to six cycles plus bevacizumab', 'cisplatin-gemcitabine and bevacizumab or placebo', 'cisplatin-gemcitabine', 'bevacizumab', 'Bevacizumab', 'platinum-based chemotherapy']","['Overall survival', 'progression-free survival (PFS); OS', 'PFS prolongation', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.370411,"The PFS benefit did not translate into a significant OS benefit, possibly due to high use of efficacious second-line therapies.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Krankenhaus Grosshansdorf, Grosshansdorf. Electronic address: dr.martin.reck@web.de.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'von Pawel', 'Affiliation': 'Pneumology Clinic, Asklepios Fachkliniken, München-Gauting, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zatloukal', 'Affiliation': 'Department of Pneumology and Thoracic Surgery, 3rd Faculty of Medicine, Charles University, Faculty Hospital Bulovka and Postgraduate Medical School, Prague, Czech Republic.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Regional Center for Lung Disease, Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Poznan, Poland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gorbounova', 'Affiliation': 'Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hirsh', 'Affiliation': 'Medical Oncology Department, McGill University Health Centre-Royal Victoria Hospital, Montreal.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Leighl', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Hospital, Toronto, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mezger', 'Affiliation': 'Medical Department II, St Vincentius-Kliniken, Karlsruhe, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Archer', 'Affiliation': 'Department of Late-Stage Clinical Development, F. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Manegold', 'Affiliation': 'Department of Surgery, Interdisciplinary Thoracic Oncology, Heidelberg University Medical Center, Mannheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq020'] 1233,31546056,Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis.,"BACKGROUND & AIMS Little is known about the association between rectal bleeding and increased stool frequency with endoscopic findings in patients with mild to moderate ulcerative colitis (UC). We evaluated the associations between rectal bleeding or stool frequency and endoscopic remission in this population. METHODS We performed a post-hoc analysis of data from a phase 3 non-inferiority trial of 817 adults with mild to moderate UC who received treatment with mesalazine. We obtained information on rectal bleeding, stool frequency, and Mayo endoscopic subscores (MESs) at weeks 0, 8, and 38. The sensitivity, specificity, and positive and negative predictive values with which rectal bleeding and stool frequency identified patients with MESs of 0 and/or 1 were calculated at weeks 8 and 38 of treatment. The associations between change in rectal bleeding and stool frequency and change in MES after treatment were quantified using the Spearman's rank correlation coefficient. RESULTS Among patients with a MES of 0, 7/82 patients (9%) had a rectal bleeding score of 1 or more and 40/82 patients (49%) had a stool frequency score of 1 or more at week 8; at week 38, 6/167 patients (4%) had a rectal bleeding score of 1 or more and 63/167 patients (38%) had a stool frequency score of 1 or more. Among patients with MESs of 0 or 1, 50/310 patients (16%) had a rectal bleeding score of 1 or more and 162/310 patients (52%) had had a stool frequency score of 1 or more at week 8; at week 38, 18/363 patients (5%) had a rectal bleeding score of 1 or more and 141/363 patients (39%) had a stool frequency score of 1 or more. The Spearman rank correlation coefficients for change in rectal bleeding and stool frequency with change in MES at week 8 were 0.39 (95% CI, 0.32-0.45) and 0.34 (95% CI, 0.27-0.40), respectively. In patients with reduced MESs at week 8, 39/389 patients (10%) had unchanged or worsening rectal bleeding and 81/389 patients (21%) had unchanged or increasing stool frequencies. CONCLUSIONS In a post-hoc analysis of data from a phase 3 trial of adults with mild to moderate UC treated with mesalazine, we found absence of rectal bleeding to identify patients in endoscopic remission. However, many patients in remission still have increased stool frequency, indicating that it may not be a sensitive marker of disease activity in patients with mild to moderate UC.",2020,"The Spearman rank correlation coefficients for change in rectal bleeding and stool frequency with change in MES at week 8 were 0.39 (95% CI, 0.32-0.45) and 0.34 (95% CI, 0.27-0.40), respectively.","['adults with mild to moderate UC treated with', 'patients with mild to moderate UC', '817 adults with mild to moderate UC who received treatment with', 'patients with mild to moderate ulcerative colitis (UC']",['mesalazine'],"['rectal bleeding or stool frequency and endoscopic remission', 'rectal bleeding score', 'stool frequency score', 'Mucosal Inflammation', 'rectal bleeding and stool frequency and change in MES', 'worsening rectal bleeding', 'rectal bleeding, stool frequency, and Mayo endoscopic subscores (MESs', 'rectal bleeding', 'sensitivity, specificity, and positive and negative predictive values with which rectal bleeding and stool frequency', 'stool frequencies', 'stool frequency', 'rectal bleeding and stool frequency with change in MES']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]","[{'cui': 'C0127615', 'cui_str': 'mesalazine'}]","[{'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",817.0,0.0770266,"The Spearman rank correlation coefficients for change in rectal bleeding and stool frequency with change in MES at week 8 were 0.39 (95% CI, 0.32-0.45) and 0.34 (95% CI, 0.27-0.40), respectively.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada; Robarts Clinical Trials, Inc, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Robarts Clinical Trials, Inc, London, Ontario, Canada; Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Robarts Clinical Trials, Inc, London, Ontario, Canada; Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Guangyong', 'Initials': 'G', 'LastName': 'Zou', 'Affiliation': 'Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Stitt', 'Affiliation': 'Robarts Clinical Trials, Inc, London, Ontario, Canada.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Ashwin N', 'Initials': 'AN', 'LastName': 'Ananthakrishnan', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Parambir S', 'Initials': 'PS', 'LastName': 'Dulai', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Division of Gastroenterology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Division of Gastroenterology, Western University, London, Ontario, Canada. Electronic address: vjairath@uwo.ca.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Division of Gastroenterology, Western University, London, Ontario, Canada.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.09.021'] 1234,32407947,"Intralymphatic immunotherapy for mountain cedar pollinosis: A randomized, double-blind, placebo-controlled trial.","BACKGROUND Allergen immunotherapy can provide long-term benefits, including symptomatic relief and reduced disease progression, but it requires a lengthy regimen that presents barriers to patient adherence. Thus, there is a need for improved approaches to immunotherapy. Recently, several clinical trials have reported successful results from intralymphatic immunotherapy. OBJECTIVE To evaluate the efficacy, safety, and tolerability of intralymphatic immunotherapy for allergies caused by mountain cedar pollen in a proof-of-concept study. METHODS A total of 21 patients with allergic rhinoconjunctivitis because of mountain cedar pollen were randomized to receive 3 monthly intralymphatic injections of allergenic extract or placebo before the 2018-2019 mountain cedar pollen season. Safety was monitored during treatment to the end of the pollen season using structured and spontaneous reports. Clinical efficacy information was collected using a daily electronic diary of symptoms and allergy medication. Allergen-specific serum immunoglobulin E was assessed before treatment and at the end of the study. RESULTS There were no serious adverse events or systemic reactions in either group. A total of 4 patients experienced mild injection-site reactions. Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (P < .001), and the active treatment group had lower average total combined scores on 20 of 27 days during the peak pollen season (P < .05). There was no significant difference among groups in changes to mean mountain cedar-specific serum immunoglobulin E levels. CONCLUSION In this proof-of-concept trial, intralymphatic immunotherapy was well tolerated and improved the symptoms and medication use associated with allergic rhinoconjunctivitis caused by mountain cedar pollen. TRIAL REGISTRATION This study was registered at ClinicalTrials.gov under the registration number NCT03682965 before the enrollment of the first subject.",2020,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"['mountain cedar pollinosis', 'prior to the 2018-2019 mountain cedar pollen season', 'Twenty-one patients with allergic rhinoconjunctivitis due to mountain cedar pollen']","['allergenic extract or placebo', 'intralymphatic immunotherapy', 'Intralymphatic immunotherapy', 'placebo']","['Safety', 'allergy symptoms and medication use relative', 'serious adverse events or systemic reactions', 'efficacy, safety and tolerability', 'mild injection-site reactions', 'mean mountain cedar-specific serum IgE levels', 'average total combined scores']","[{'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0440386', 'cui_str': 'Mountain cedar pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0440016', 'cui_str': 'Allergenic extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",21.0,0.239599,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Thompson', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Silvers', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Mark Adam', 'Initials': 'MA', 'LastName': 'Shapiro', 'Affiliation': 'Pharma Initiatives Consulting, Chapel Hill, North Carolina. Electronic address: mshapiro@pharmainitiatives.com.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.030'] 1235,30667502,Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial.,"Importance Pediatric guidelines for the management of nonalcoholic fatty liver disease (NAFLD) recommend a healthy diet as treatment. Reduction of sugary foods and beverages is a plausible but unproven treatment. Objective To determine the effects of a diet low in free sugars (those sugars added to foods and beverages and occurring naturally in fruit juices) in adolescent boys with NAFLD. Design, Setting, and Participants An open-label, 8-week randomized clinical trial of adolescent boys aged 11 to 16 years with histologically diagnosed NAFLD and evidence of active disease (hepatic steatosis >10% and alanine aminotransferase level ≥45 U/L) randomized 1:1 to an intervention diet group or usual diet group at 2 US academic clinical research centers from August 2015 to July 2017; final date of follow-up was September 2017. Interventions The intervention diet consisted of individualized menu planning and provision of study meals for the entire household to restrict free sugar intake to less than 3% of daily calories for 8 weeks. Twice-weekly telephone calls assessed diet adherence. Usual diet participants consumed their regular diet. Main Outcomes and Measures The primary outcome was change in hepatic steatosis estimated by magnetic resonance imaging proton density fat fraction measurement between baseline and 8 weeks. The minimal clinically important difference was assumed to be 4%. There were 12 secondary outcomes, including change in alanine aminotransferase level and diet adherence. Results Forty adolescent boys were randomly assigned to either the intervention diet group or the usual diet group (20 per group; mean [SD] age, 13.0 [1.9] years; most were Hispanic [95%]) and all completed the trial. The mean decrease in hepatic steatosis from baseline to week 8 was significantly greater for the intervention diet group (25% to 17%) vs the usual diet group (21% to 20%) and the adjusted week 8 mean difference was -6.23% (95% CI, -9.45% to -3.02%; P < .001). Of the 12 prespecified secondary outcomes, 7 were null and 5 were statistically significant including alanine aminotransferase level and diet adherence. The geometric mean decrease in alanine aminotransferase level from baseline to 8 weeks was significantly greater for the intervention diet group (103 U/L to 61 U/L) vs the usual diet group (82 U/L to 75 U/L) and the adjusted ratio of the geometric means at week 8 was 0.65 U/L (95% CI, 0.53 to 0.81 U/L; P < .001). Adherence to the diet was high in the intervention diet group (18 of 20 reported intake of <3% of calories from free sugar during the intervention). There were no adverse events related to participation in the study. Conclusions and Relevance In this study of adolescent boys with NAFLD, 8 weeks of provision of a diet low in free sugar content compared with usual diet resulted in significant improvement in hepatic steatosis. However, these findings should be considered preliminary and further research is required to assess long-term and clinical outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT02513121.",2019,"There were no adverse events related to participation in the study. ","['≥45', 'Forty adolescent boys', 'group (20 per group; mean [SD] age, 13.0 [1.9] years; most were Hispanic [95%]) and all completed the trial', 'group at 2 US academic clinical research centers from August 2015 to July 2017; final date of follow-up was September 2017', 'Adolescent Boys', 'adolescent boys with NAFLD', 'adolescent boys aged 11 to 16 years with histologically diagnosed NAFLD and evidence of active disease (hepatic steatosis']","['Low Free Sugar Diet vs Usual Diet', 'diet low in free sugars (those sugars added to foods and beverages and occurring naturally in fruit juices', 'intervention diet group or the usual diet', 'Usual diet participants consumed their regular diet', 'intervention diet group or usual diet', 'individualized menu planning and provision of study meals for the entire household to restrict free sugar intake to less than 3% of daily calories']","['alanine aminotransferase level', 'hepatic steatosis', 'Nonalcoholic Fatty Liver Disease', 'change in alanine aminotransferase level and diet adherence', 'alanine aminotransferase level and diet adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0524819', 'cui_str': 'Food and Beverages'}, {'cui': 'C0452453', 'cui_str': 'Fruit Juices'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",40.0,0.0766749,"There were no adverse events related to participation in the study. ","[{'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, School of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ugalde-Nicalo', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, School of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Welsh', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Angeles', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, School of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cordero', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Harlow', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, School of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adina', 'Initials': 'A', 'LastName': 'Alazraki', 'Affiliation': ""Department of Radiology, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Durelle', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, School of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Knight-Scott', 'Affiliation': ""Department of Radiology, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Newton', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, School of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cleeton', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Knott', 'Affiliation': 'Altman Clinical and Translational Research Institute, School of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Juna', 'Initials': 'J', 'LastName': 'Konomi', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Middleton', 'Affiliation': 'Liver Imaging Group, Department of Radiology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Travers', 'Affiliation': 'Pediatric Biostatistics Core, Department of Pediatrics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Claude B', 'Initials': 'CB', 'LastName': 'Sirlin', 'Affiliation': 'Liver Imaging Group, Department of Radiology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Ahlia', 'Initials': 'A', 'LastName': 'Sekkarie', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'McCracken', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University, Atlanta, Georgia.'}]",JAMA,['10.1001/jama.2018.20579'] 1236,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery. STUDY DESIGN A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques. SETTING A tertiary health care referral center. SUBJECTS AND METHODS The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate. RESULTS Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009). CONCLUSION Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Nassar', 'Initials': 'N', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087'] 1237,32408022,Supporting Syrian families displaced by armed conflict: A pilot randomized controlled trial of the Caregiver Support Intervention.,"BACKGROUND The impact of armed conflict and displacement on children's mental health is strongly mediated by compromised parenting stemming from persistently high caregiver stress. Parenting interventions for refugees emphasize the acquisition of parenting knowledge and skills, while overlooking the deleterious effects of chronic stress on parenting. War Child Holland's Caregiver Support Intervention (CSI) aims to strengthen parenting by lowering stress and improving psychosocial wellbeing among refugee parents, while also increasing knowledge and skill related to positive parenting. The CSI is a nine-session group intervention delivered by non-specialist providers. OBJECTIVE We describe the findings of a two-arm pilot randomized controlled trial of the CSI with Syrian refugees in Lebanon. The primary aim was to test the feasibility of our study methodology prior to conducting a definitive RCT. METHODS We recruited 78 families (151 parents), who were randomized to the CSI or a waitlist control group. Data were collected at baseline and post-intervention. RESULTS Randomization was successful, retention was high (99 %), as was intervention completion (95 % among women, 86 % among men). Implementation fidelity was excellent. Blinding was largely, though not completely effective. The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management. CSI parents reported increased child psychosocial wellbeing. Control families showed no significant change on any variable. CONCLUSIONS Findings demonstrate the feasibility of our methodology for a definitive RCT, and suggest that the CSI shows promise as a scalable approach to strengthening parenting in refugee communities. Trial registration # ISRCTN33665023.",2020,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","['78 families (151 parents', ""children's mental health""]","['CSI', 'Caregiver Support Intervention', ""War Child Holland's Caregiver Support Intervention (CSI""]","['parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management', 'child psychosocial wellbeing']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",78.0,0.126032,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Kenneth.Miller@warchild.nl.'}, {'ForeName': 'Gabriela V', 'Initials': 'GV', 'LastName': 'Koppenol-Gonzalez', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Gabriela.Koppenol@warchild.nl.'}, {'ForeName': 'Maguy', 'Initials': 'M', 'LastName': 'Arnous', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Maguy.Arnous@warchild.nl.'}, {'ForeName': 'Fadila', 'Initials': 'F', 'LastName': 'Tossyeh', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Fadila.Tossyeh@warchild.nl.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Harvard University, United States. Electronic address: Alexandra.chen@post.harvard.edu.'}, {'ForeName': 'Nayla', 'Initials': 'N', 'LastName': 'Nahas', 'Affiliation': 'University of Balamand, Lebanon. Electronic address: Nayla.Nahas@balamand.edu.lb.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands; Amsterdam Institute of Social Science Research, University of Amsterdam, The Netherlands. Electronic address: Mark.Jordans@warchild.nl.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104512'] 1238,29059349,Using Elastic Net Penalized Cox Proportional Hazards Regression to Identify Predictors of Imminent Smoking Lapse.,"Introduction Machine learning algorithms such as elastic net regression and backward selection provide a unique and powerful approach to model building given a set of psychosocial predictors of smoking lapse measured repeatedly via ecological momentary assessment (EMA). Understanding these predictors may aid in developing interventions for smoking lapse prevention. Methods In a randomized-controlled smoking cessation trial, smartphone-based EMAs were collected from 92 participants following a scheduled quit date. This secondary analysis utilized elastic net-penalized cox proportional hazards regression and model approximation via backward elimination to (1) optimize a predictive model of time to first lapse and (2) simplify that model to its core constituent predictors to maximize parsimony and generalizability. Results Elastic net proportional hazards regression selected 17 of 26 possible predictors from 2065 EMAs to model time to first lapse. The predictors with the highest magnitude regression coefficients were having consumed alcohol in the past hour, being around and interacting with a smoker, and having cigarettes easily available. This model was reduced using backward elimination, retaining five predictors and approximating to 93.9% of model fit. The retained predictors included those mentioned above as well as feeling irritable and being in areas where smoking is either discouraged or allowed (as opposed to not permitted). Conclusions The strongest predictors of smoking lapse were environmental in nature (e.g., being in smoking-permitted areas) as opposed to internal factors such as psychological affect. Interventions may be improved by a renewed focus of interventions on these predictors. Implications The present study demonstrated the utility of machine learning algorithms to optimize the prediction of time to smoking lapse using EMA data. The two models generated by the present analysis found that environmental factors were most strongly related to smoking lapse. The results support the use of machine learning algorithms to investigate intensive longitudinal data, and provide a foundation for the development of highly tailored, just-in-time interventions that can target on multiple antecedents of smoking lapse.",2019,The present study demonstrated the utility of machine learning algorithms to optimize the prediction of time to smoking lapse using EMA data.,['92 participants following a scheduled quit date'],"['smartphone-based EMAs', 'machine learning algorithms']",[],"[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002045'}]",[],92.0,0.0137798,The present study demonstrated the utility of machine learning algorithms to optimize the prediction of time to smoking lapse using EMA data.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Emily T', 'Initials': 'ET', 'LastName': 'Hébert', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, Oklahoma City, OK.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ma', 'Affiliation': ""Division of Population Health, Children's Medical Center, Dallas, TX.""}, {'ForeName': 'Darla E', 'Initials': 'DE', 'LastName': 'Kendzor', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, Oklahoma City, OK.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Businelle', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, Oklahoma City, OK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntx201'] 1239,30473033,"Effects of Delayed Cord Clamping on 4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment: A Randomized Controlled Trial.","OBJECTIVE To evaluate whether placental transfusion influences brain myelination at 4 months of age. STUDY DESIGN A partially blinded, randomized controlled trial was conducted at a level III maternity hospital in the US. Seventy-three healthy term pregnant women and their singleton fetuses were randomized to either delayed umbilical cord clamping (DCC, >5 minutes) or immediate clamping (ICC, <20 seconds). At 4 months of age, blood was drawn for ferritin levels. Neurodevelopmental testing (Mullen Scales of Early Learning) was administered, and brain myelin content was measured with magnetic resonance imaging. Correlations between myelin content and ferritin levels and group-wise DCC vs ICC brain myelin content were completed. RESULTS In the DCC and ICC groups, clamping time was 172 ± 188 seconds vs 28 ± 76 seconds (P < .002), respectively; the 48-hour hematocrit was 57.6% vs 53.1% (P < .01). At 4 months, infants with DCC had significantly greater ferritin levels (96.4 vs 65.3 ng/dL, P = .03). There was a positive relationship between ferritin and myelin content. Infants randomized to the DCC group had greater myelin content in the internal capsule and other early maturing brain regions associated with motor, visual, and sensory processing/function. No differences were seen between groups in the Mullen testing. CONCLUSION At 4 months, infants born at term receiving DCC had greater ferritin levels and increased brain myelin in areas important for early life functional development. Endowment of iron-rich red blood cells obtained through DCC may offer a longitudinal advantage for early white matter development. TRIAL REGISTRATION ClinicalTrials.gov: NCT01620008.",2018,"Infants randomized to the DCC group had greater myelin content in the internal capsule and other early maturing brain regions associated with motor, visual, and sensory processing/function.","['level III maternity hospital in the US', 'Seventy-three healthy term pregnant women and their singleton fetuses']","['Delayed Cord Clamping', 'placental transfusion', 'delayed umbilical cord clamping (DCC, >5 minutes) or immediate clamping (ICC', 'iron-rich red blood cells obtained through DCC', 'DCC']","['4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment', 'motor, visual, and sensory processing/function', '48-hour hematocrit', 'clamping time', 'ferritin levels', 'Neurodevelopmental testing (Mullen Scales of Early Learning']","[{'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0026969', 'cui_str': 'Myelin'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",73.0,0.220685,"Infants randomized to the DCC group had greater myelin content in the internal capsule and other early maturing brain regions associated with motor, visual, and sensory processing/function.","[{'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Mercer', 'Affiliation': 'College of Nursing, University of Rhode Island, Kingston, RI; Pediatrics, Alpert School of Medicine, Brown University, Providence, RI; Department of Pediatrics, Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Erickson-Owens', 'Affiliation': 'College of Nursing, University of Rhode Island, Kingston, RI; Department of Pediatrics, Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Sean C L', 'Initials': 'SCL', 'LastName': 'Deoni', 'Affiliation': 'Advanced Baby Imaging Lab, Memorial Hospital of Rhode Island, Pawtucket, RI; Department of Radiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Dean', 'Affiliation': 'Waisman Center, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Parker', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Meijia', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Joelson', 'Affiliation': 'Advanced Baby Imaging Lab, Memorial Hospital of Rhode Island, Pawtucket, RI.'}, {'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'Mercer', 'Affiliation': 'Advanced Baby Imaging Lab, Memorial Hospital of Rhode Island, Pawtucket, RI.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Padbury', 'Affiliation': 'Pediatrics, Alpert School of Medicine, Brown University, Providence, RI; Department of Pediatrics, Women and Infants Hospital of Rhode Island, Providence, RI.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2018.06.006'] 1240,30498836,Pre Frail 80: Multifactorial Intervention to Prevent Progression of Pre-Frailty to Frailty in the Elderly.,"OBJECTIVES Preventing or delaying frailty has important benefits in the elderly, and in health and social services. Studies have demonstrated the effectiveness of multifactorial interventions in the frail elderly, but there are fewer studies on community-dwelling pre-frail individuals. Identifying pre-frail individuals susceptible to intervention could prevent or delay frailty and its consequences and associated disability and might reverse the state from pre-frail to robust. To evaluate a multifactorial, interdisciplinary primary care intervention in community-dwelling pre-frail elderly patients aged ≥ 80 years. DESIGN Randomized clinical trial in a Barcelona primary healthcare centre. SETTING We included 200 community-dwelling subjects aged ≥ 80 years meeting the Fried pre-frailty criteria. Participants were randomized to intervention and control groups. INTERVENTION The intervention group received a 6-month interdisciplinary intervention based on physical exercise, Mediterranean diet advice, assessment of inadequate prescribing in polypharmacy patients and social assessment, while the control group received standard primary healthcare treatment. RESULTS 173 pre-frail participants (86.5%) completed the study; mean age 84.5 years, 64.5% female. At twelve months, frailty was lower in the intervention group (RR 2.90; 95%CI 1.45 to 8.69). Reversion to robustness was greater in the intervention group (14.1% vs.1.1%, p <0.001). Functional and nutritional status, adherence to Mediterranean diet, quality of life, and functional mobility were improved in the intervention group (p ≤0.001). CONCLUSION A multifactorial, interdisciplinary primary healthcare intervention focused on physical exercise, nutrition, review of polypharmacy and social assessment prevented frailty in pre-frail elderly patients, and improved functional capacity, quality of life and adherence to the Mediterranean diet.",2018,"Functional and nutritional status, adherence to Mediterranean diet, quality of life, and functional mobility were improved in the intervention group (p ≤0.001). ","['pre-frail elderly patients', 'community-dwelling pre-frail elderly patients aged ≥ 80 years', '200 community-dwelling subjects aged ≥ 80 years meeting the Fried pre-frailty criteria', 'Barcelona primary healthcare centre', '173 pre-frail participants (86.5%) completed the study; mean age 84.5 years, 64.5% female']","['6-month interdisciplinary intervention based on physical exercise, Mediterranean diet advice, assessment of inadequate prescribing in polypharmacy patients and social assessment, while the control group received standard primary healthcare treatment', 'interdisciplinary primary care intervention']","['Functional and nutritional status, adherence to Mediterranean diet, quality of life, and functional mobility', 'Reversion to robustness', 'functional capacity, quality of life and adherence']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0079377', 'cui_str': 'Frail Elders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1320310', 'cui_str': 'Social assessment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0034380'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",200.0,0.0316325,"Functional and nutritional status, adherence to Mediterranean diet, quality of life, and functional mobility were improved in the intervention group (p ≤0.001). ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gené Huguet', 'Affiliation': ""L. Gené Huguet Specialist family physician, Centro de Salud Borrell, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE), Barcelona, Spain, laiagenehuguet@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Navarro González', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kostov', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ortega Carmona', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Colungo Francia', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Carpallo Nieto', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hervás Docón', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vilarrasa Sauquet', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'García Prado', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sisó-Almirall', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-018-1089-2'] 1241,30378203,Efficacy of a Mediterranean diet supplemented with fatty fish in ameliorating inflammation in paediatric asthma: a randomised controlled trial.,"BACKGROUND Childhood asthma is the most common respiratory disorder worldwide, being associated with increased morbidity and a decreased quality of life. Omega-3 fatty acids have anti-inflammatory and immunomodulating properties; however, their efficacy in asthma is controversial. The present study aimed to examine the efficacy of a Mediterranean diet supplemented with a high omega-3 'fatty' fish intake in Greek asthmatic children. METHODS A single-centred, 6-month, parallel randomised controlled trial compared the consumption of a Mediterranean diet supplemented with two meals of 150 g of cooked fatty fish weekly (intervention) with the usual diet (control) with respect to pulmonary function in children (aged 5-12 years) with mild asthma. Pulmonary function was assessed using spirometry and bronchial inflammation by fractional exhaled nitric oxide analysis. RESULTS Sixty-four children (52% male, 48% female) successfully completed the trial. Fatty fish intake increased in the intervention group from 17 g day -1 at baseline to 46 g day -1 at 6 months (P < 0.001). In the unadjusted analysis, the effect of the intervention was of borderline significance (P = 0.06, β = -11.93; 95% confidence interval = -24.32 to 0.46). However, after adjusting for age, sex, body mass index and regular physical activity, a significant effect was observed (P = 0.04, β = -14.15 ppb; 95% confidence interval = -27.39 to -0.91). No difference was observed for spirometry, asthma control and quality of life scores. CONCLUSIONS A Mediterranean diet supplemented with two fatty fish meals per week might be a potential strategy for reducing airway inflammation in childhood asthma. Future robust clinical trials are warranted to replicate and corroborate these findings.",2019,"No difference was observed for spirometry, asthma control and quality of life scores. ","['Sixty-four children (52% male, 48% female) successfully completed the trial', 'paediatric asthma', 'Greek asthmatic children', 'children (aged 5-12\xa0years) with mild asthma']","[""Mediterranean diet supplemented with a high omega-3 'fatty' fish intake"", 'Mediterranean diet supplemented with fatty fish', 'Omega-3 fatty acids', 'Mediterranean diet supplemented with two meals of 150\xa0g of cooked fatty fish weekly (intervention) with the usual diet (control']","['Fatty fish intake', 'Pulmonary function', 'spirometry, asthma control and quality of life scores']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0554965', 'cui_str': 'Greek (NMO) (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0556218', 'cui_str': 'Fatty fish intake (observable entity)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",64.0,0.121515,"No difference was observed for spirometry, asthma control and quality of life scores. ","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Papamichael', 'Affiliation': 'Department of Rehabilitation, Nutrition & Sport, School of Allied Health, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Katsardis', 'Affiliation': 'National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lambert', 'Affiliation': 'Department of Public Health, School of Psychology & Public Health, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tsoukalas', 'Affiliation': 'European Institute of Nutritional Medicine, Rome, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koutsilieris', 'Affiliation': 'National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Erbas', 'Affiliation': 'Department of Public Health, School of Psychology & Public Health, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Itsiopoulos', 'Affiliation': 'Department of Rehabilitation, Nutrition & Sport, School of Allied Health, La Trobe University, Melbourne, VIC, Australia.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12609'] 1242,30657434,Feasibility and Acceptability of e-Screening and Brief Intervention and Tailored Text Messaging for Marijuana Use in Pregnancy.,"Background: There are at present no evidence-based interventions for marijuana use during pregnancy, despite it being by far the most commonly used illicit drug during pregnancy. Lack of treatment-seeking, combined with implementation challenges, has limited the extent to which at-risk women receive interventions of any kind. This study sought to evaluate the feasibility and acceptability of two high-reach technology-based interventions: electronic screening and brief intervention (e-SBI) and tailored text messaging, delivered either alone or in combination. Materials and Methods: In this exploratory feasibility trial, pregnant women seeking prenatal care services and scoring positive for marijuana use risk ( n  = 45) were randomly assigned to e-SBI, text messaging, or e-SBI plus text messaging. We examined completion rates and acceptability ratings as a function of intervention condition and participant characteristics. Results: All participants assigned to receive the e-SBI ( n  = 30) were able to complete it during the in-clinic baseline session. Participants assigned to text messaging ( n  = 30) received a median of 24 text messages before giving birth; 6 of 30 (20%) chose to end text messages before giving birth. Acceptability ratings for the e-SBI were high, with most being above 4.4 on a 5-point scale ( e.g ., for ease of use, respectfulness, and helpfulness). Acceptability ratings for some aspects of the texting intervention were also high ( e.g ., for ease of understanding and respectfulness). Participants in the combined e-SBI plus texting condition chose to stop messages at a rate of 13.3% (2 of 15), versus 26.7% (4 of 15) in the texting-only condition ( p  = 0.37). Conclusions: These two high-reach intervention elements showed strong feasibility and modest to high acceptability. Future efforts evaluating efficacy are warranted, and should specifically examine the possibility that combining text messaging with a brief intervention may promote retention.",2019,"Participants in the combined e-SBI plus texting condition chose to stop messages at a rate of 13.3% (2 of 15), versus 26.7% (4 of 15) in the texting-only condition (p = 0.37). ","['Marijuana Use in Pregnancy', 'pregnant women seeking prenatal care services and scoring positive for marijuana use risk (n\u2009=\u200945']","['e-SBI, text messaging, or e-SBI plus text messaging', 'e-Screening and Brief Intervention and Tailored Text Messaging', 'two high-reach technology-based interventions: electronic screening and brief intervention (e-SBI) and tailored text messaging, delivered either alone or in combination']","['completion rates and acceptability ratings', 'Acceptability ratings', 'feasibility and acceptability']","[{'cui': 'C4316909', 'cui_str': 'Marijuana Use'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",45.0,0.0613142,"Participants in the combined e-SBI plus texting condition chose to stop messages at a rate of 13.3% (2 of 15), versus 26.7% (4 of 15) in the texting-only condition (p = 0.37). ","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Beatty', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Karoline S', 'Initials': 'KS', 'LastName': 'Puder', 'Affiliation': 'Department of Obstetrics & Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Janisse', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Dace S', 'Initials': 'DS', 'LastName': 'Svikis', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7169'] 1243,30428059,Improvement of social support in empty-nest elderly: results from an intervention study based on the Self-Mutual-Group model.,"BACKGROUND China has the world's largest elderly population and an increasing number of empty-nest elderly. The purpose of this study is to evaluate the effectiveness of the Self-Mutual-Group model on social support of the empty-nest elderly, thus providing reference for improving their quality of life. METHODS A intervention study was conducted between October 2016 and May 2017 at six communities in Taiyuan, Shanxi Province, China. A total of 350 empty-nest elderly aged 60-88 years were randomly assigned in the intervention group (n = 167) with a 7-month SMG-based intervention or to a control group (n = 183) with no intervention. The social support of the participating elderly (n = 350) was assessed by the Social Support Rating Scale (SSRS) at the baseline and 7 months later, respectively. RESULTS A 7-month follow-up showed an increasing mean scores of SSRS, objective support, subjective support and support utilization of the intervention group, and reached statistical significance (P < 0.05). CONCLUSIONS The Self-Mutual-Group model was considered to be a positive intervention and was effective in increasing social support among the empty-nest elderly. Furthermore, future research should extend the intervention period and introduce multi-point measurement to better evaluate the intervention process and outcomes. TRIAL REGISTRATION Study on the 'SMG' Health Management Model Based on Community Organization Theory among empty-nest elderly (ChiCTR1800015884).",2019,"A 7-month follow-up showed an increasing mean scores of SSRS, objective support, subjective support and support utilization of the intervention group, and reached statistical significance (P < 0.05). ","['350 empty-nest elderly aged 60-88 years', 'empty-nest elderly', 'October 2016 and May 2017 at six communities in Taiyuan, Shanxi Province, China']","['SMG-based intervention or to a control group (n = 183) with no intervention', 'Self-Mutual-Group model']","['mean scores of SSRS, objective support, subjective support and support utilization', 'Social Support Rating Scale (SSRS']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0037438'}, {'cui': 'C0222045'}]",167.0,0.0148325,"A 7-month follow-up showed an increasing mean scores of SSRS, objective support, subjective support and support utilization of the intervention group, and reached statistical significance (P < 0.05). ","[{'ForeName': 'Chichen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'School of Management, Shanxi Medical University, No. 56, Xinjian South Road, Taiyuan, Shanxi, China.'}, {'ForeName': 'Huining', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'School of Management, Shanxi Medical University, No. 56, Xinjian South Road, Taiyuan, Shanxi, China.'}, {'ForeName': 'Ruifang', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'School of Nursing, Shanxi Medical University, No. 56, Xinjian South Road, Taiyuan, Shanxi, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'School of Management, Shanxi Medical University, No. 56, Xinjian South Road, Taiyuan, Shanxi, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'School of Management, Shanxi Medical University, No. 56, Xinjian South Road, Taiyuan, Shanxi, China.'}, {'ForeName': 'Xiaozhao Yousef', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Political Science and Sociology, Murray State University, 102 Curris Center, Murray, KY, USA.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'College of Humanities and Social Sciences, Harbin Medical University, No. 194, Xuefu Road, Nangang District, Harbin, Heilongjiang, China.'}, {'ForeName': 'Tingzhong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'School of Medicine, Zhejiang University, No. 866, Yuhangtang Road, Hangzhou, Zhejiang, China.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdy185'] 1244,31334554,A Mediterranean Diet Rich in Extra-Virgin Olive Oil Is Associated with a Reduced Prevalence of Nonalcoholic Fatty Liver Disease in Older Individuals at High Cardiovascular Risk.,"BACKGROUND Adherence to a Mediterranean diet (MedDiet) is thought to reduce liver steatosis. OBJECTIVES To explore the associations with liver steatosis of 3 different diets: a MedDiet + extra-virgin olive oil (EVOO), MedDiet + nuts, or a control diet. METHODS This was a subgroup analysis nested within a multicenter, randomized, parallel-group clinical trial, PREvención con DIeta MEDiterránea (PREDIMED trial: ISRCTN35739639), aimed at assessing the effect of a MedDiet on the primary prevention of cardiovascular disease. One hundred men and women (mean age: 64 ± 6 y), at high cardiovascular risk (62% with type 2 diabetes) from the Bellvitge-PREDIMED center were randomly assigned to a MedDiet supplemented with EVOO, a MedDiet supplemented with mixed nuts, or a control diet (advice to reduce all dietary fat). No recommendations to lose weight or increase physical activity were given. Main measurements were the percentage of liver fat and the diagnosis of steatosis, which were determined by NMR imaging. The association of diet with liver fat content was analyzed by bivariate analysis after a median follow-up of 3 y. RESULTS Baseline adiposity and cardiometabolic risk factors were similar among the 3 treatment arms. At 3 y after the intervention hepatic steatosis was present in 3 (8.8%), 12 (33.3%), and 10 (33.3%) of the participants in the MedDiet + EVOO, MedDiet + nuts, and control diet groups, respectively (P = 0.027). Respective mean values of liver fat content were 1.2%, 2.7%, and 4.1% (P = 0.07). A tendency toward significance was observed for the MedDiet + EVOO group compared with the control group. Median values of urinary 12(S)-hydroxyeicosatetraenoic acid/creatinine concentrations were significantly (P = 0.001) lower in the MedDiet + EVOO (2.3 ng/mg) than in the MedDiet + nuts (5.0 ng/mg) and control (3.9 ng/mg) groups. No differences in adiposity or glycemic control changes were seen between groups. CONCLUSIONS An energy-unrestricted MedDiet supplemented with EVOO, a food with potent antioxidant and anti-inflammatory properties, is associated with a reduced prevalence of hepatic steatosis in older individuals at high cardiovascular risk.",2019,"At 3 y after the intervention hepatic steatosis was present in 3 (8.8%), 12 (33.3%), and 10 (33.3%) of the participants in the MedDiet + EVOO, MedDiet + nuts, and control diet groups, respectively (P = 0.027).","['Older Individuals at High Cardiovascular Risk', 'older individuals at high cardiovascular risk', 'One hundred men and women (mean age: 64\xa0±\xa06 y), at high cardiovascular risk (62% with type 2 diabetes) from the Bellvitge-PREDIMED center']","['MedDiet supplemented with EVOO, a MedDiet supplemented with mixed nuts, or a control diet (advice to reduce all dietary fat', 'MedDiet\xa0+\xa0extra-virgin olive oil (EVOO), MedDiet\xa0+\xa0nuts, or a control diet', 'Mediterranean diet (MedDiet']","['adiposity or glycemic control changes', 'percentage of liver fat and the diagnosis of steatosis', 'weight or increase physical activity', 'hepatic steatosis', 'Baseline adiposity and cardiometabolic risk factors', 'Median values of urinary 12(S)-hydroxyeicosatetraenoic acid/creatinine concentrations', 'liver fat content']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0453347', 'cui_str': 'Mixed nuts (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020349', 'cui_str': 'HETE'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",100.0,0.061293,"At 3 y after the intervention hepatic steatosis was present in 3 (8.8%), 12 (33.3%), and 10 (33.3%) of the participants in the MedDiet + EVOO, MedDiet + nuts, and control diet groups, respectively (P = 0.027).","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fanlo-Maresma', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Emili', 'Initials': 'E', 'LastName': 'Corbella', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Corbella', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'M Teresa', 'Initials': 'MT', 'LastName': 'Mitjavila', 'Affiliation': 'Departament de Biologia Cel.lular, Fisiologia i Immunologia, Facultat de Biologia, INSA-UB, Universidad de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Moreno', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxz147'] 1245,29861437,Short-Term Particulate Air Pollution Exposure is Associated with Increased Severity of Respiratory and Quality of Life Symptoms in Patients with Fibrotic Sarcoidosis.,"This study aimed to determine if short-term exposure to particulate matter (PM 2.5 ) and ozone (O₃) is associated with increased symptoms or lung function decline in fibrotic sarcoidosis. Sixteen patients with fibrotic sarcoidosis complicated by frequent exacerbations completed pulmonary function testing and questionnaires every three months for one year. We compared 7-, 10-, and 14-day average levels of PM 2.5 and O₃ estimated at patient residences to spirometry (forced expiratory volume in 1 s (FEV1), to forced vital capacity (FVC), episodes of FEV1 decline > 10%) and questionnaire outcomes (Leicester cough questionnaire (LCQ), Saint George Respiratory Questionnaire (SGRQ), and King's Sarcoidosis Questionnaire (KSQ)) using generalized linear mixed effect models. PM 2.5 level averaged over 14 days was associated with lower KSQ general health status (score change -6.60 per interquartile range (IQR) PM 2.5 increase). PM 2.5 level averaged over 10 and 14 days was associated with lower KSQ lung specific health status (score change -6.93 and -6.91, respectively). PM 2.5 levels were not associated with FEV₁, FVC, episodes of FEV₁ decline > 10%, or respiratory symptoms measured by SGRQ or LCQ. Ozone exposure was not associated with any health outcomes. In this small cohort of patients with fibrotic sarcoidosis, PM 2.5 exposure was associated with increased severity of respiratory and quality of life symptoms.",2018,PM 2.5 level averaged over 14 days was associated with lower KSQ general health status (score change -6.60 per interquartile range (IQR) PM 2.5 increase).,"['Sixteen patients with fibrotic sarcoidosis', 'Patients with Fibrotic Sarcoidosis']",['particulate matter (PM 2.5 ) and ozone (O₃'],"['Severity of Respiratory and Quality of Life Symptoms', 'KSQ general health status', 'KSQ lung specific health status', ""14-day average levels of PM 2.5 and O₃ estimated at patient residences to spirometry (forced expiratory volume in 1 s (FEV1), to forced vital capacity (FVC), episodes of FEV1 decline > 10%) and questionnaire outcomes (Leicester cough questionnaire (LCQ), Saint George Respiratory Questionnaire (SGRQ), and King's Sarcoidosis Questionnaire (KSQ"", 'FEV₁, FVC, episodes of FEV₁ decline > 10%, or respiratory symptoms', 'severity of respiratory and quality of life symptoms']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036202', 'cui_str': ""Boeck's Sarcoid""}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0036202', 'cui_str': ""Boeck's Sarcoid""}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}]",16.0,0.0199598,PM 2.5 level averaged over 14 days was associated with lower KSQ general health status (score change -6.60 per interquartile range (IQR) PM 2.5 increase).,"[{'ForeName': 'Cheryl S', 'Initials': 'CS', 'LastName': 'Pirozzi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Utah, Salt Lake City, UT 84132, USA. cheryl.pirozzi@hsc.utah.edu.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Mendoza', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Utah, Salt Lake City, UT 84132, USA. Daniel.Mendoza@utah.edu.'}, {'ForeName': 'Yizhe', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Population Health Science, University of Utah, Salt Lake City, UT 84132, USA. yizhe.xu@hsc.utah.edu.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Divisions of Epidemiology and Public Health, Department of Internal Medicine, University of Utah, Salt Lake City, UT 84132, USA. zhang.yue@hsc.utah.edu.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Scholand', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Utah, Salt Lake City, UT 84132, USA. mary.beth.scholand@hsc.utah.edu.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Baughman', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati, Cincinnati, OH 45219, USA. BAUGHMRP@ucmail.uc.edu.'}]",International journal of environmental research and public health,['10.3390/ijerph15061077'] 1246,31666906,Post-Activation Potentiation: Is there an Optimal Training Volume and Intensity to Induce Improvements in Vertical Jump Ability in Highly-Trained Subjects?,"The aim of this study was to compare the acute effects of performing half squats (HSs) with different loading intensities (1, 3, and 5 repetitions maximum [RM], and 60% 1RM) and a different number of sets (1, 2, and 3) on the countermovement jump (CMJ) performance of 18 highly-trained male subjects. Participants were submitted to four experimental conditions (1RM, 3RM, 5RM, and 60% 1RM) in randomized order. The CMJ was assessed before and after each set. Differences in CMJ performance between the distinct experimental conditions and individual responses in CMJ performance induced by the different protocols were analyzed via the magnitude-based inference method. Overall, significant improvements were detected in individual CMJ heights after each activation protocol. It can be concluded that the use of 1 to 3 sets of HSs performed at moderate-to-high loads may be an effective strategy to improve jump performance in highly-trained subjects. Nonetheless, despite the high efficiency of the protocols tested here, coaches and researchers are strongly encouraged to perform individualized assessments within the proposed range of loads and sets, to find optimal and tailored post-activation potentiation protocols.",2019,Differences in CMJ performance between the distinct experimental conditions and individual responses in CMJ performance induced by the different protocols were analyzed via the magnitude-based inference method.,['18 highly-trained male subjects'],"['Post-Activation Potentiation', 'performing half squats (HSs']","['individual CMJ heights', 'CMJ performance', 'countermovement jump (CMJ) performance', 'jump performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]",18.0,0.0215646,Differences in CMJ performance between the distinct experimental conditions and individual responses in CMJ performance induced by the different protocols were analyzed via the magnitude-based inference method.,"[{'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Kobal', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Lucas A', 'Initials': 'LA', 'LastName': 'Pereira', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Anderson C', 'Initials': 'AC', 'LastName': 'Paulo', 'Affiliation': 'Academic Department of Physical Education of the Federal Technological University of Paraná, Paraná Brazil.'}, {'ForeName': 'Henrique A', 'Initials': 'HA', 'LastName': 'Ramos', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Everton C', 'Initials': 'EC', 'LastName': 'Carmo', 'Affiliation': 'Physical Education, Senac University Center, São Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valmor', 'Initials': 'V', 'LastName': 'Tricoli', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': 'Faculty of Science and Technology, London Sports Institute, Middlesex University, London, UK.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'NAR - Nucleus of High Performance in Sport, São Paulo, Brazil.'}]",Journal of human kinetics,['10.2478/hukin-2019-0016'] 1247,29988125,Verapamil and beta cell function in adults with recent-onset type 1 diabetes.,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking. We previously reported that the approved antihypertensive calcium-channel blocker verapamil, by decreasing the expression of thioredoxin-interacting protein, promotes the survival of insulin-producing beta cells and reverses diabetes in mouse models 1 . To translate these findings into humans, we conducted a randomized double-blind placebo-controlled phase 2 clinical trial ( NCT02372253 ) to assess the efficacy and safety of oral verapamil added for 12 months to a standard insulin regimen in adult subjects with recent-onset T1D. Verapamil treatment, compared with placebo was well tolerated and associated with an improved mixed-meal-stimulated C-peptide area under the curve, a measure of endogenous beta cell function, at 3 and 12 months (prespecified primary endpoint), as well as with a lower increase in insulin requirements, fewer hypoglycemic events and on-target glycemic control (secondary endpoints). Thus, addition of once-daily oral verapamil may be a safe and effective novel approach to promote endogenous beta cell function and reduce insulin requirements and hypoglycemic episodes in adult individuals with recent-onset T1D.",2018,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking.","['adult subjects with recent-onset T1D', 'adults with recent-onset type 1 diabetes', 'adult individuals with recent-onset T1D']","['Verapamil', 'placebo', 'verapamil', 'oral verapamil', 'antihypertensive calcium-channel blocker verapamil', 'Verapamil treatment']","['insulin requirements, fewer hypoglycemic events and on-target glycemic control (secondary endpoints', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.123525,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Grimes', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Guanlan', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anish J', 'Initials': 'AJ', 'LastName': 'Patel', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Truman B', 'Initials': 'TB', 'LastName': 'Grayson', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Thielen', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anath', 'Initials': 'A', 'LastName': 'Shalev', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. shalev@uab.edu.'}]",Nature medicine,['10.1038/s41591-018-0089-4'] 1248,31676953,Effect of Early Adverse Events on Survival Outcomes of Patients with Metastatic Colorectal Cancer Treated with Ramucirumab.,"BACKGROUND Studies of patients treated with bevacizumab and other vascular epithelial growth factor (VEGF) inhibitors have reported that hypertension adverse events (AEs) are associated with improved overall survival (OS) or progression-free survival (PFS). OBJECTIVE Our objective was to evaluate the association between early AEs and survival outcomes for patients treated with ramucirumab, an antibody targeting the VEGF receptor-2 (VEGFR-2), plus FOLFIRI for metastatic colorectal cancer (mCRC). METHODS Data from 529 patients treated with ramucirumab plus FOLFIRI for mCRC in the RAISE clinical trial (NCT01183780) were evaluated to see whether early (first 6 weeks of therapy) AEs predicted subsequent OS and PFS. A Cox proportional hazard approach was used to evaluate associations between early AEs and survival outcomes. A secondary analysis between FOLFIRI and placebo was conducted as a sensitivity analysis. RESULTS Of 529 patients treated with ramucirumab plus FOLFIRI, 479 were alive and progression free at 6 weeks after commencing therapy. No significant association was identified between hypertension occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and OS (grade 1-2, hazard ratio [HR] 0.90 [95% confidence interval (CI) 0.66-1.24]; grade 3+, HR 1.02 [95% CI 0.67-1.55]; P = 0.803) or PFS (grade 1-2, HR 0.98 [95% CI 0.74-1.28]; grade 3+, HR 0.93 [95% CI 0.64-1.37]; P = 0.93). However, there was a significant association between diarrhea occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and worse OS (grade 1-2, HR 0.96 [95% CI 0.76-1.20]; grade 3+, HR 2.72 [95% CI 1.67-4.44]; P = 0.001) and PFS (grade 1-2, HR 1.01 [95% CI 0.83-1.23]; grade 3+, HR 2.22 [95% CI 1.43-3.45]; P = 0.005). No other AEs were significantly associated with OS or PFS. CONCLUSIONS Ramucirumab-induced hypertension was not associated with improved OS and PFS in patients with mCRC treated with ramucirumab and FOLFIRI, but severe diarrhea was associated with poorer OS and PFS. CLINICAL TRIAL REGISTRATION No. NCT01183780.",2019,"No significant association was identified between hypertension occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and OS (grade 1-2, hazard ratio [HR] 0.90 [95% confidence interval (CI) 0.66-1.24]; grade 3+, HR 1.02","['patients treated with ramucirumab, an antibody targeting the VEGF receptor-2 (VEGFR-2), plus FOLFIRI for metastatic colorectal cancer (mCRC', 'Patients with Metastatic Colorectal Cancer Treated with', '529 patients treated with']","['FOLFIRI and placebo', 'Ramucirumab', 'ramucirumab plus FOLFIRI', 'bevacizumab and other vascular epithelial growth factor (VEGF) inhibitors', 'ramucirumab plus FOLFIRI for mCRC']","['severe diarrhea', 'overall survival (OS) or progression-free survival (PFS', 'OS and PFS', 'hypertension', 'Survival Outcomes', 'PFS', 'diarrhea', 'subsequent OS and PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0378796', 'cui_str': 'Flk-1 Protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",479.0,0.295579,"No significant association was identified between hypertension occurring within the first 42 days of ramucirumab plus FOLFIRI therapy and OS (grade 1-2, hazard ratio [HR] 0.90 [95% confidence interval (CI) 0.66-1.24]; grade 3+, HR 1.02","[{'ForeName': 'Huezin H', 'Initials': 'HH', 'LastName': 'Lim', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia. lim0654@flinders.edu.au.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Hoi Y', 'Initials': 'HY', 'LastName': 'Yuen', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, 5042, Australia.'}]",Targeted oncology,['10.1007/s11523-019-00683-z'] 1249,30610424,Bevacizumab versus bevacizumab and macular grid photocoagulation for macular edema in eyes with non-ischemic branch retinal vein occlusion: results from a prospective randomized study.,"BACKGROUND The objective of the study was the investigation of the effects of intravitreal bevacizumab (BEV) with or without additional macular grid laser photocoagulation (GRID) for macular edema (ME) secondary to branch retinal vein occlusion (BRVO). METHODS Prospective, randomized, monocentric study. Thirty-two patients were included. Initially, all eyes in both groups received three monthly injections of BEV, followed by additional injections if re-treatment criteria were met. In the BEV + GRID group, photocoagulation was performed 2 weeks after the first BEV injection and laser re-treatment was allowed. The follow-up was 38 weeks. Main outcome measures were best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Changes of foveal avascular zone (FAZ) and of retinal ischemia, as well as the number of injections were also evaluated. RESULTS Sixteen eyes were randomized into each group. At baseline, BCVA was similar in both groups (BEV + GRID: 20/71; BEV: 20/60; P = 0.51). At 38 weeks, BCVA significantly improved in the two groups (BEV + GRID gain of 9 ± 11.2 letters and 16.25 ± 10.08 letters in the BEV) with no difference between them (P < 0.06). With regard to anatomical findings, initial CRT in BEV + GRID was 496.2 μm ± 138.4 μm and 538.9 μm ± 156.9 μm in BEV (P < 0.1697). At 38 weeks, CRT decreased in both groups significantly, 98.2 μm in the BEV + GRID (P = 0.02) and 141.7 μm in the BEV group (P = 0.01), with no significant difference between groups (P < 0.17). The area of FAZ a significantly increased in both groups (41% (P = 0.04) in BEV + GRID; 35% (P = 0.03) in BEV) during the study and the grade of peripheral ischemia remained unchanged. The mean number of injections was 3.8 (range 3-6) with no significant difference between groups. CONCLUSIONS Our data demonstrate a beneficial effect of bevacizumab in ME in eyes with BRVO. A loading phase of three injections led to a significant improvement in vision in both groups, which persisted at week 38. Additional grid laser photocoagulation exhibited no beneficial functional or anatomical effect during the study, nor did it reduce the number of injections. The FAZ area increased significantly in both groups, but overall retinal ischemia did not. Further studies investigating more numerous eyes and longer follow-up are needed to confirm these data.",2019,The area of FAZ a significantly increased in both groups (41% (P = 0.04) in BEV + GRID; 35% (P = 0.03) in BEV) during the study and the grade of peripheral ischemia remained unchanged.,"['Thirty-two patients were included', 'macular edema in eyes with non-ischemic branch retinal vein occlusion', 'eyes with BRVO', 'Sixteen eyes']","['bevacizumab', 'Additional grid laser photocoagulation', 'Bevacizumab', 'intravitreal bevacizumab (BEV) with or without additional macular grid laser photocoagulation (GRID', 'bevacizumab and macular grid photocoagulation']","['area of FAZ', 'grade of peripheral ischemia', 'corrected visual acuity (BCVA) and central retinal thickness (CRT', 'vision', 'mean number of injections', 'foveal avascular zone (FAZ) and of retinal ischemia', 'BEV + GRID', 'overall retinal ischemia', 'BCVA', 'FAZ area', 'CRT']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion (disorder)'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C1302035', 'cui_str': 'Grid photocoagulation'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0235490', 'cui_str': 'Peripheral ischemia (disorder)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0162291', 'cui_str': 'Retinal ischemia (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",32.0,0.0538105,The area of FAZ a significantly increased in both groups (41% (P = 0.04) in BEV + GRID; 35% (P = 0.03) in BEV) during the study and the grade of peripheral ischemia remained unchanged.,"[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Callizo', 'Affiliation': 'Department of Ophthalmology, University Medical Center Goettingen, Robert-Koch-Str 40, 37075, Goettingen, Germany. josep.callizo@med.uni-goettingen.de.'}, {'ForeName': 'Abed', 'Initials': 'A', 'LastName': 'Atili', 'Affiliation': 'Augen Praxis Klinik Esslingen, Adler-Str6, 73728, Esslingen, Germany.'}, {'ForeName': 'Nina Antonia', 'Initials': 'NA', 'LastName': 'Striebe', 'Affiliation': 'Department of Ophthalmology, University Medical Center Goettingen, Robert-Koch-Str 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bemme', 'Affiliation': 'Department of Ophthalmology, University Medical Center Goettingen, Robert-Koch-Str 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Feltgen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Goettingen, Robert-Koch-Str 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hoerauf', 'Affiliation': 'Department of Ophthalmology, University Medical Center Goettingen, Robert-Koch-Str 40, 37075, Goettingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bertelmann', 'Affiliation': 'Department of Ophthalmology, University Medical Center Goettingen, Robert-Koch-Str 40, 37075, Goettingen, Germany.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-018-04223-9'] 1250,29195590,"Age differences in outcomes among patients in the ""Stimulant Abuser Groups to Engage in 12-Step"" (STAGE-12) intervention.","Emerging adults (roughly 18-29years) with substance use disorders can benefit from participation in twelve-step mutual-help organizations (TSMHO), however their attendance and participation in such groups is relatively low. Twelve-step facilitation therapies, such as the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), may increase attendance and involvement, and lead to decreased substance use. AIMS Analyses examined whether age moderated the STAGE-12 effects on substance use and TSMHO meeting attendance and participation. DESIGN We utilized data from a multisite randomized controlled trial, with assessments at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3- and 6- months post-randomization. PARTICIPANTS Participants were adults with DSM-IV diagnosed stimulant abuse or dependence (N=450) enrolling in 10 intensive outpatient substance use treatment programs across the U.S. ANALYSIS A zero-inflated negative binomial random-effects regression model was utilized to examine age-by-treatment interactions on substance use and meeting attendance and involvement. FINDINGS Younger age was associated with larger treatment effects for stimulant use. Specifically, younger age was associated with greater odds of remaining abstinent from stimulants in STAGE-12 versus Treatment-as-Usual; however, among those who were not abstinent during treatment, younger age was related to greater rates of stimulant use at follow-up for those in STAGE-12 compared to TAU. There was no main effect of age on stimulant use. Younger age was also related to somewhat greater active involvement in different types of TSMHO activities among those in STAGE-12 versus TAU. There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition. These results suggest that STAGE-12 can be beneficial for some emerging adults with stimulant use disorder, and ongoing assessment of continued use is of particular importance.",2018,"There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition.","['Emerging adults (roughly 18-29years) with substance use disorders', 'Participants were adults with DSM-IV diagnosed stimulant abuse or dependence (N=450) enrolling in 10 intensive outpatient substance use treatment programs across the U.S']",['STAGE-12'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1456332', 'cui_str': 'Stimulant abuse'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",[],450.0,0.0236687,"There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition.","[{'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Garrett', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States. Electronic address: ghungus@uw.edu.'}, {'ForeName': 'Suzanne R', 'Initials': 'SR', 'LastName': 'Doyle', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States.'}, {'ForeName': 'K Michelle', 'Initials': 'KM', 'LastName': 'Peavy', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States; Evergreen Treatment Services, 1700 Airport Way South, Seattle, WA 98134, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Wells', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States.'}, {'ForeName': 'Mandy D', 'Initials': 'MD', 'LastName': 'Owens', 'Affiliation': 'Health Services Research & Development, VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA 98118, United States.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Shores-Wilson', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 5390-9119, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'DiCenzo', 'Affiliation': 'Zuckerberg San Francisco General Hospital, 1001 Potrero Ave Rm 1C12, San Francisco, CA 94110, United States.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2017.10.012'] 1251,24700332,Internet-delivered treatment for substance abuse: a multisite randomized controlled trial.,"OBJECTIVE Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. METHOD Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255). TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment as usual consisted of individual and group counseling at the participating programs. The primary outcome measures were abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment. RESULTS Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35). This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry (N=228) (odds ratio=2.18, 95% CI=1.30, 3.68). CONCLUSIONS Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes. Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES.",2014,"Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35).","['Adult men and women', 'substance abuse', 'N=507) entering 10 outpatient addiction treatment programs']","['Therapeutic Education System (TES', 'usual (N=252) or treatment as usual plus TES']","['dropout rate', 'abstinence rate', 'abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment', 'positive urine drug or breath alcohol screen']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",10.0,0.0998591,"Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35).","[{'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Stitzer', 'Affiliation': ''}, {'ForeName': 'Gloria M', 'Initials': 'GM', 'LastName': 'Miele', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Turrigiano', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Walters', 'Affiliation': ''}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': ''}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Kyle', 'Affiliation': ''}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Wahle', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Veldhuisen', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Babcock', 'Affiliation': ''}, {'ForeName': 'Patricia Quinn', 'Initials': 'PQ', 'LastName': 'Stabile', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}, {'ForeName': 'Udi E', 'Initials': 'UE', 'LastName': 'Ghitza', 'Affiliation': ''}]",The American journal of psychiatry,['10.1176/appi.ajp.2014.13081055'] 1252,30610875,Concurrent anodal transcranial direct-current stimulation and motor task to influence sensorimotor cortex activation.,"Functional targeting with anodal high-definition transcranial direct current stimulation (HD-atDCS) of involved brain areas during performance of a motor task (online) may facilitate sensorimotor cortex neuroplasticity compared to performing the motor task after HD-atDCS (offline). The aim of this study was to employ functional near-infrared spectroscopy to compare the time course of motor task-related changes in sensorimotor cortex activation between online and offline HD-atDCS. We hypothesized that online HD-atDCS would have a greater effect on task-related sensorimotor cortex activation than offline HD-atDCS. In a within-subject sham controlled and randomized study design, 9 healthy participants underwent 3 HD-atDCS sessions (online, offline and sham) targeting the left sensorimotor cortex separated by 1 week. Functional near-infrared spectroscopy hemodynamic changes were measured from the left sensorimotor cortex during a simple finger opposition motor task before (Pre), immediately (T1) and 30 min after (T2) each session. The movement rates were not different between (online, offline, sham) or within (Pre, T1, T2) sessions. At T2, online HD-atDCS was associated with a significant increase (large effect size) in sensorimotor cortex activation (Hedges g = 1.01, p < 0.001) when compared to sham; there was a nonsignificant trend to increase activation between offline and sham (Hedges g = 0.52, p = 0.05) and between online and offline (Hedges g = 0.53, p = 0.06). Concurrent application of HD-atDCS during a motor task may produce larger sensorimotor cortex activation than sequential application.",2019,"At T2, online HD-atDCS was associated with a significant increase (large effect size) in sensorimotor cortex activation (Hedges g = 1.01, p < 0.001) when compared to sham; there was a nonsignificant trend to increase activation between offline and sham (Hedges g = 0.52, p = 0.05) and between online and offline (Hedges g = 0.53, p = 0.06).",['9 healthy participants underwent 3'],"['anodal high-definition transcranial direct current stimulation (HD-atDCS', 'HD-atDCS sessions (online, offline and sham) targeting the left sensorimotor cortex separated by 1\u202fweek', 'Concurrent anodal transcranial direct-current stimulation and motor task', 'HD-atDCS']","['increase activation', 'sensorimotor cortex activation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}]",9.0,0.0401089,"At T2, online HD-atDCS was associated with a significant increase (large effect size) in sensorimotor cortex activation (Hedges g = 1.01, p < 0.001) when compared to sham; there was a nonsignificant trend to increase activation between offline and sham (Hedges g = 0.52, p = 0.05) and between online and offline (Hedges g = 0.53, p = 0.06).","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Besson', 'Affiliation': 'EuroMov, Univ. Montpellier, Montpellier, France.'}, {'ForeName': 'Makii', 'Initials': 'M', 'LastName': 'Muthalib', 'Affiliation': 'EuroMov, Univ. Montpellier, Montpellier, France; SilverLine Research Services, Brisbane, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Dray', 'Affiliation': ""LG2IP, Ecole des Mines d'Ales, France.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rothwell', 'Affiliation': 'Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Perrey', 'Affiliation': 'EuroMov, Univ. Montpellier, Montpellier, France. Electronic address: stephane.perrey@umontpellier.fr.'}]",Brain research,['10.1016/j.brainres.2019.01.003'] 1253,30610210,Hyaluronic acid injection in glans penis for treatment of premature ejaculation: a randomized controlled cross-over study.,"This randomized controlled cross-over study aimed to assess the efficacy and safety of glans penis injection with hyaluronic acid (HA) in treating premature ejaculation (PE). A total of 30 patients with PE were randomly allocated into two groups: group 1 (n = 15) which was subjected to glans penis HA injection and group 2 (n = 15) which was injected with saline as a control then both groups were subjected to follow-up at 1 week and 1 month after injection. These subjects were evaluated by intra-vaginal ejaculation latency time (IELT) and the Arabic validated index of premature ejaculation (AIPE). After a wash-out period, cross-over and re-evaluation of both groups were carried. Additionally, patients with reported improvement after 1 month of HA injection (n = 20) were subjected to extended evaluation by IELT at 3, 6, and 9 months intervals. Two-way repeated measures ANOVA indicated significant improvement after HA in comparison with saline across the follow-up periods (F(1.66: 91.37) = 24.85, p = 0.001). Post-hoc Bonferroni test indicated no significant difference after 1 week period in comparison with baseline IELT, but a significant difference after 1 month of injection in comparison with baseline IELT (p < 0.001) and after 1 week (p < 0.001). After 1 month of HA, IELT increased by a median of 2.6 folds while 1.1 folds increase was observed after 1 month of saline injection. Total AIPE scores improved significantly after HA injection compared with baseline (p = 0.003) and saline scores (p = 0.002). Reported adverse effects were minimal and self-limited. It could be concluded that glans penis injection with HA for treatment of PE is a safe method that ensures a modest but significant increase in IELT and improves couple sexual satisfaction.",2019,Total AIPE scores improved significantly after HA injection compared with baseline (p = 0.003) and saline scores (p = 0.002).,"['treating premature ejaculation (PE', '30 patients with PE', 'premature ejaculation']","['glans penis injection with hyaluronic acid (HA', 'glans penis HA injection and group 2 (n\u2009=\u200915) which was injected with saline', 'Hyaluronic acid injection']","['intra-vaginal ejaculation latency time (IELT) and the Arabic validated index of premature ejaculation (AIPE', 'adverse effects', 'Total AIPE scores', 'IELT', 'efficacy and safety']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030851', 'cui_str': 'Penile structure (body structure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0566549,Total AIPE scores improved significantly after HA injection compared with baseline (p = 0.003) and saline scores (p = 0.002).,"[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Alahwany', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed W', 'Initials': 'MW', 'LastName': 'Ragab', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt. dr.wa2el@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaghloul', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Abdallah', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Taymour', 'Initials': 'T', 'LastName': 'Mostafa', 'Affiliation': 'Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",International journal of impotence research,['10.1038/s41443-018-0104-9'] 1254,31679812,Effectiveness of group visits for elderly patients with type 2 diabetes in an urban community in China.,"The purpose of this study is to evaluate the effectiveness of a group visit intervention in comparison with the usual care for elderly patients with type 2 diabetes in a community. We randomized 109 community elderly patients with type 2 diabetes to the intervention group (n = 55) of monthly group visits sessions or to a control group (n = 54) of usual care. Repeated measures analysis of variance was used to compare the changes in HbA1 C , diabetes knowledge, self-efficacy, and self-management behavior in both groups. At the 6-month follow-up, although no significant difference was observed between the groups regarding HbA1 C (p = 0.272). Diabetes knowledge, self-efficacy and self-management scores were higher in patients in the intervention group than that in the control group (p < 0.05). The group visits model increased diabetes knowledge and self-efficacy and improved patients' self-management behavior. The model was found suitable for helping these elderly patients with type 2 diabetes achieve effective self-management.",2020,"Diabetes knowledge, self-efficacy and self-management scores were higher in patients in the intervention group than that in the control group (p < 0.05).","['109 community elderly patients with type 2 diabetes to the intervention group (n\u202f=\u202f55) of', 'elderly patients with type 2 diabetes in a community', 'elderly patients with type 2 diabetes in an urban community in China', 'elderly patients with type 2 diabetes']",['monthly group visits sessions or to a control group (n\u202f=\u202f54) of usual care'],"[""diabetes knowledge and self-efficacy and improved patients' self-management behavior"", 'Diabetes knowledge, self-efficacy and self-management scores', 'changes in HbA1 C , diabetes knowledge, self-efficacy, and self-management behavior']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",109.0,0.0131256,"Diabetes knowledge, self-efficacy and self-management scores were higher in patients in the intervention group than that in the control group (p < 0.05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Qingdao University, Qingdao, Shandong province, China.'}, {'ForeName': 'Liangxiu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Medical College, Quzhou College of Technology, Quzhou, Zhejiang province, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Cui', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'The Anbu community of Harbin, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China. Electronic address: 13603618212@126.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.10.001'] 1255,31747786,Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial.,"BACKGROUND The use of nonsteroidal anti-inflammatory drugs (NSAIDs) with oral anticoagulants has been associated with an increased risk of bleeding. We investigated the risk of bleeding and major cardiovascular outcomes in patients with atrial fibrillation taking NSAIDs and apixaban or warfarin. METHODS The ARISTOTLE trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; n=18 201) compared apixaban with warfarin in patients with atrial fibrillation at an increased risk of stroke. Patients in ARISTOTLE without severe renal (creatine clearance ≤30 mL/min) or liver disease were included in this analysis (n=17 423). NSAID use at baseline, NSAID use during the trial (incident NSAID use), and never users were described. The primary outcome was major bleeding. Secondary outcomes included clinically relevant nonmajor bleeding, gastrointestinal bleeding, heart failure hospitalization, stroke or systemic embolism, and all-cause mortality. NSAID use during the trial, and the interaction between randomized treatment, was analyzed using time-dependent Cox proportional hazards models. RESULTS Those with baseline NSAID use (n=832 [4.8%]), incident NSAID use (n=2185 [13.2%]), and never users were similar in median age (age [25th, 75th]; 70 [64, 77] versus 70 [63, 75] versus 70 [62, 76]). Those with NSAID use at baseline and incident NSAID use were more likely to have a history of bleeding than never users (24.5% versus 21.0% versus 15.6%, respectively). During a median follow-up (25th, 75th) of 1.8 (1.4, 2.3) years and when excluding those taking NSAID at baseline, we found that incident NSAID use was associated with an increased risk of major bleeding (hazard ratio [HR], 1.61 [95% CI, 1.11-2.33]) and clinically relevant nonmajor bleeding (HR, 1.70 [95% CI, 1.16-2.48]), but not gastrointestinal bleeding. No significant interaction was observed between NSAID use and randomized treatment for any outcome. CONCLUSIONS A substantial number of patients in the ARISTOTLE trial took NSAIDs. Incident NSAID use was associated with major and clinically relevant nonmajor bleeding, but not with gastrointestinal bleeding. The safety and efficacy of apixaban versus warfarin appeared not significantly to be altered by NSAID use. This study warrants more investigation of the effect of NSAIDs on the outcomes of patients treated with apixaban. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00412984.",2020,No significant interaction was observed between NSAID use and randomized treatment for any outcome. ,"['patients with atrial fibrillation (AF) taking NSAIDs and apixaban or warfarin', 'Patients with Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants', 'Patients in ARISTOTLE without severe renal (creatine clearance ≤30 mL/min) or liver disease were included in this analysis (n=17,423', 'patients with AF at increased risk of stroke', 'patients treated with apixaban']","['nonsteroidal anti-inflammatory drugs (NSAIDs) with oral anticoagulants', 'apixaban versus warfarin', 'NSAIDs', 'apixaban with warfarin']","['gastrointestinal bleeding', 'risk of major bleeding (hazard ratio [HR', 'history of bleeding', 'clinically relevant non-major (CRNM) bleeding, gastrointestinal bleeding, heart failure hospitalization, stroke or systemic embolism, and all-cause mortality', 'major bleeding', 'risk of bleeding', 'risk of bleeding and major cardiovascular outcomes', 'clinically relevant non-major bleeding', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.18801,No significant interaction was observed between NSAID use and randomized treatment for any outcome. ,"[{'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, Hellerup, Denmark (F.D.).'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Sweden (C.H., L.W.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Institute of Cardiology, University of Pisa, Italy (R.D.).'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Washam', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hylek', 'Affiliation': 'Boston University School of Medicine, MA (E.M.H.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Garcia', 'Affiliation': 'University of Washington School of Medicine, Seattle, (D.A.G.).'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN (B.J.G.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Sweden (C.H., L.W.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041296'] 1256,30950300,Peers Keep It Real: Re-engaging Adults in HIV Care.,"BACKGROUND After diagnosis, a substantial number of people with HIV disease fall out of care. Effective interventions are needed for this priority population. METHODS The ""Peers Keep It Real"" study aimed to help adults who were disengaged from HIV treatment. Peers, lay individuals living with HIV, facilitated intervention sessions. Participants were randomized to immediately receive the peer-facilitated intervention or were wait-listed. RESULTS Considerable attrition occurred in the control group. Pre-/postanalyses showed that among participants (n = 23) who received the intervention, 65% had viral load suppression and 100% remained in care at 12 months postintervention. Impact on viral load was significant ( P = .0326), suggesting that peers are effective change agents who positively impacted outcomes for individuals struggling with adherence to HIV treatment. CONCLUSION Future endeavors should consider providing all individuals from this priority population with an active peer intervention from the onset to enhance retention and adherence.",2019,"Impact on viral load was significant ( P = .0326), suggesting that peers are effective change agents who positively impacted outcomes for individuals struggling with adherence to HIV treatment. ","['people with HIV disease fall out of care', 'Peers, lay individuals living with HIV, facilitated intervention sessions']",['peer-facilitated intervention or were wait-listed'],"['viral load', 'Considerable attrition', 'viral load suppression']","[{'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",,0.0855689,"Impact on viral load was significant ( P = .0326), suggesting that peers are effective change agents who positively impacted outcomes for individuals struggling with adherence to HIV treatment. ","[{'ForeName': 'Maithe', 'Initials': 'M', 'LastName': 'Enriquez', 'Affiliation': '1 Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'An-Lin', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': '2 School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McKinsey', 'Affiliation': '3 Metro Infectious Disease Consultants, Kansas City, MO, USA.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Farnan', 'Affiliation': '4 Truman Medical Center-Hospital Hill, Kansas City, MO, USA.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Ortego', 'Affiliation': '4 Truman Medical Center-Hospital Hill, Kansas City, MO, USA.'}, {'ForeName': 'Deana', 'Initials': 'D', 'LastName': 'Hayes', 'Affiliation': '4 Truman Medical Center-Hospital Hill, Kansas City, MO, USA.'}, {'ForeName': 'LaTrischa', 'Initials': 'L', 'LastName': 'Miles', 'Affiliation': '5 Kansas City Care Clinic, Kansas City, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reese', 'Affiliation': '5 Kansas City Care Clinic, Kansas City, MO, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Downes', 'Affiliation': '6 AIDS United, Washington, DC, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Enriquez', 'Affiliation': '7 ReDiscover, Lees Summit, MO, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Akright', 'Affiliation': '1 Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'El Atrouni', 'Affiliation': '8 KU Medical Center, Kansas City, KS, USA.'}]",Journal of the International Association of Providers of AIDS Care,['10.1177/2325958219838858'] 1257,27410922,Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting.,"BACKGROUND We examined the efficacy of olanzapine for the prevention of nausea and vomiting in patients receiving highly emetogenic chemotherapy. METHODS In a randomized, double-blind, phase 3 trial, we compared olanzapine with placebo, in combination with dexamethasone, aprepitant or fosaprepitant, and a 5-hydroxytryptamine type 3-receptor antagonist, in patients with no previous chemotherapy who were receiving cisplatin (≥70 mg per square meter of body-surface area) or cyclophosphamide-doxorubicin. The doses of the three concomitant drugs administered before and after chemotherapy were similar in the two groups. The two groups received either 10 mg of olanzapine orally or matching placebo daily on days 1 through 4. Nausea prevention was the primary end point; a complete response (no emesis and no use of rescue medication) was a secondary end point. RESULTS In the analysis, we included 380 patients who could be evaluated (192 assigned to olanzapine, and 188 to placebo). The proportion of patients with no chemotherapy-induced nausea was significantly greater with olanzapine than with placebo in the first 24 hours after chemotherapy (74% vs. 45%, P=0.002), the period from 25 to 120 hours after chemotherapy (42% vs. 25%, P=0.002), and the overall 120-hour period (37% vs. 22%, P=0.002). The complete-response rate was also significantly increased with olanzapine during the three periods: 86% versus 65% (P<0.001), 67% versus 52% (P=0.007), and 64% versus 41% (P<0.001), respectively. Although there were no grade 5 toxic effects, some patients receiving olanzapine had increased sedation (severe in 5%) on day 2. CONCLUSIONS Olanzapine, as compared with placebo, significantly improved nausea prevention, as well as the complete-response rate, among previously untreated patients who were receiving highly emetogenic chemotherapy. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02116530.).",2016,"The complete-response rate was also significantly increased with olanzapine during the three periods: 86% versus 65% (P<0.001), 67% versus 52% (P=0.007), and 64% versus 41% (P<0.001), respectively.","['patients receiving highly emetogenic chemotherapy', '380 patients who could be evaluated (192 assigned to', 'patients with no previous chemotherapy who were receiving']","['dexamethasone, aprepitant or fosaprepitant, and a 5-hydroxytryptamine type 3-receptor antagonist', 'placebo', 'cyclophosphamide-doxorubicin', 'cisplatin', 'olanzapine orally or matching placebo', 'olanzapine', 'olanzapine, and 188 to placebo', 'Olanzapine', 'olanzapine with placebo']","['nausea and vomiting', 'Nausea and Vomiting', 'Nausea prevention', 'complete response (no emesis and no use of rescue medication', 'nausea prevention', 'complete-response rate', 'proportion of patients with no chemotherapy-induced nausea', 'sedation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",380.0,0.328044,"The complete-response rate was also significantly increased with olanzapine during the three periods: 86% versus 65% (P<0.001), 67% versus 52% (P=0.007), and 64% versus 41% (P<0.001), respectively.","[{'ForeName': 'Rudolph M', 'Initials': 'RM', 'LastName': 'Navari', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Qin', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Powell', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Bajaj', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Dietrich', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Biggs', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Lafky', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'From Indiana University School of Medicine-South Bend, South Bend (R.M.N.); Alliance Statistics and Data Center, Mayo Clinic (R.Q., H.L.), and Mayo Clinic (K.J.R., J.M.L., C.L.L.), Rochester, MN; Sanford NCORP (National Cancer Institute Community Oncology Research Program) of the North Central Plains, Sioux Falls, SD (S.F.P.); Illinois Cancer Care-Peoria, Peoria (M.B.); Gundersen Lutheran Medical Center, La Crosse, WI (L.D.); and Delaware-Christiana Care NCORP, Newark, DE (D.B.).'}]",The New England journal of medicine,['10.1056/NEJMoa1515725'] 1258,30471795,Acute consumption of Andalusian aged wine and gin decreases the expression of genes related to atherosclerosis in men with high cardiovascular risk: Randomized intervention trial.,"BACKGROUND Atherosclerosis is an inflammatory disease. Previous studies have suggested the beneficial effects of moderate consumption of alcoholic beverages on reducing cardiovascular risk (CVR). The aim of this study was to evaluate the effects of acute consumption of Andalusian aged wine (AAW) and gin by analyzing the expression of genes related to the appearance and progression of atherosclerosis in men with high CVR. METHODS We performed an open, randomized, controlled, crossover trial including 41 men with high CVR between 55 and 80 years age, who received a single dose of AAW or gin (0.5 g ethanol/kg). The expression of 10 genes related to atherosclerosis was determined by RT-PCR at baseline and 4 h after the intervention. RESULTS Gene expression analysis 4 h after consumption of each alcoholic beverage showed a significant decrease in Toll-like receptors 4 and 6 (TLR4, TLR6) and Caspase-1 (p < 0.05 all). Additionally, TLR2, Interleukin-1 receptor, chemokine receptor 3 and inflammasome expression decreased after AAW intake (p < 0.05, all) while only chemokine receptor 5 decreased after gin consumption (p = 0.039). CONCLUSION The decrease in the expression of several genes related to the appearance and progression of atherosclerosis was greater after AAW than gin intake, suggesting that the phenolic content of AAW may play a protective role against atherosclerosis.",2019,"Additionally, TLR2, Interleukin-1 receptor, chemokine receptor 3 and inflammasome expression decreased after AAW intake (p < 0.05, all) while only chemokine receptor 5 decreased after gin consumption (p = 0.039). ","['men with high cardiovascular risk', 'men with high CVR', '41 men with high CVR between 55 and 80 years age, who received a single dose of AAW or gin (0.5\xa0g ethanol/kg']",['Andalusian aged wine (AAW'],"['TLR2, Interleukin-1 receptor, chemokine receptor 3 and inflammasome expression decreased after AAW intake', 'cardiovascular risk (CVR', 'Toll-like receptors 4 and 6 (TLR4, TLR6) and Caspase-1']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0452241', 'cui_str': 'Gin (substance)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}]","[{'cui': 'C0043188', 'cui_str': 'Wine'}]","[{'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0524914'}, {'cui': 'C2936529', 'cui_str': 'Pyroptosomes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1411976', 'cui_str': 'Toll-4 Receptor'}, {'cui': 'C0534519', 'cui_str': 'IL-1 beta Convertase'}]",41.0,0.0541161,"Additionally, TLR2, Interleukin-1 receptor, chemokine receptor 3 and inflammasome expression decreased after AAW intake (p < 0.05, all) while only chemokine receptor 5 decreased after gin consumption (p = 0.039). ","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn), Instituto de Salud Carlos III (ISCIII), Spain.""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Ribó-Coll', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain.""}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Doménech', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain.""}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Lamuela-Raventós', 'Affiliation': 'CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn), Instituto de Salud Carlos III (ISCIII), Spain; Nutrition and Food Science Department-XaRTA, INSA, Pharmacy School, University of Barcelona, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn), Instituto de Salud Carlos III (ISCIII), Spain. Electronic address: restruch@clinic.ub.es.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.07.014'] 1259,31657794,Impact of High-intensity Interval Exercise and Moderate-Intensity Continuous Exercise on the Cardiac Troponin T Level at an Early Stage of Training.,"An elevation in cardiac troponin T (cTnT), as a highly specific biomarker of cardiomyocyte damage, after moderate-intensity continuous exercise (MCE) has been described. The exercise-induced cTnT response distorts the diagnostic role of the cTnT assay. Although high-intensity interval exercise (HIE) is growing in popularity and concerns remain about its safety, available data related to cTnT release after HIE is limited, which hampers the use of HIE as a health intervention. Here, we present three representative HIE protocols [traditional HIE (repeated 4 min cycling at 90% V̇O2max interspersed with 3 min rest, 200 kJ/session); sprint interval exercise (SIE, repeated 1 min cycling at 120% V̇O2max interspersed with 1.5 min rest, 200 kJ/session); and repeated sprint exercise (RSE, 40 x 6 s all-out sprints interspersed with 9 s rest)] and one representative MCE protocol (continuous cycling exercise at an intensity of 60% V̇O2max, 200 kJ/session). Forty-seven sedentary, overweight young women were randomly assigned to one of four groups (HIE, SIE, RSE, and MCE). Six bouts of respective exercise were performed by every single group, with each being 48 h apart. Meanwhile, for four groups, the duration of the entire testing period was identical, being 10 days. Before and after the first and final exercise bouts, an assessment was conducted of cTnT. The current study provides a frame of reference giving a clear picture of how a specific exercise session affects the circulating cTnT concentration at the early stage of training. The information may assist with clinical interpretations of post-exercise cTnT elevation and guide the prescription of exercise, especially for HIE.",2019,"An elevation in cardiac troponin T (cTnT), as a highly specific biomarker of cardiomyocyte damage, after moderate-intensity continuous exercise (MCE) has been described.","['Forty-seven sedentary, overweight young women']","['high-intensity interval exercise (HIE', 'V̇O2max interspersed with 3 min rest, 200 kJ/session); sprint interval exercise (SIE, repeated 1 min cycling at 120% V̇O2max interspersed with 1.5 min rest, 200 kJ/session); and repeated sprint exercise (RSE, 40 x 6 s all-out sprints interspersed with 9 s rest)] and one representative MCE protocol (continuous cycling exercise', 'High-intensity Interval Exercise and Moderate-Intensity Continuous Exercise']",['Cardiac Troponin T Level'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0256930', 'cui_str': 'mesochlorin e6 monoethylenediamine'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",47.0,0.0471502,"An elevation in cardiac troponin T (cTnT), as a highly specific biomarker of cardiomyocyte damage, after moderate-intensity continuous exercise (MCE) has been described.","[{'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Physical Education College, Hebei Normal University; Hebei Provincial Key Lab of Measurement and Evaluation in Human Movement and Bio-Information.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute; jnie@ipm.edu.mo.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Faculty of Education, University of Macau.'}, {'ForeName': 'Xiangui', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Physical Education College, Hebei Normal University.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Physical Education College, Hebei Normal University.'}, {'ForeName': 'Qingde', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute.'}]",Journal of visualized experiments : JoVE,['10.3791/60252'] 1260,30430294,Impact of vascular access site on procedural time of endomyocardial biopsy.,"Endomyocardial biopsy (EMB) is widely used for the diagnosis of unexplained ventricular dysfunction and for assessment of cardiac allograft rejection. But, the impact of vascular access site on procedural time of EMB is not well-known. From February 2014 to May 2016, consecutive patients requiring EMB were prospectively enrolled in this study. Vascular access, by either the jugular or femoral vein, was randomly assigned. EMB was randomly performed by 3 pre-identified physicians based on practical experience in EMB. Each case was required to obtain at least 3 samples. The primary endpoint was to compare the total time spent in acquiring EMB from the right ventricular septum between the jugular and femoral vein access groups. The secondary endpoints were evaluation of each set (1st to 3rd attempt) of EMB times and safety. In addition, factors affecting the EMB procedural times were evaluated. A total of 49 consecutive patients requiring EMB (3.9 attempts/patient) were enrolled (the jugular group: 23, the femoral group: 26), and 156 myocardial samples (3.2 samples/patient) were obtained. There were no significant differences in total biopsy procedural time between the 2 groups (16.3 ± 7.4 vs. 20.8 ± 9.9 min, p = 0.075). Independent predictors for longer procedural time of the 1st attempt included femoral access, non-expert operators, and larger right atrium according to multiple linear regression analysis. The complication rates were not significantly different between the 2 groups, except for catheter kinking as a technical factor. Total biopsy time was not significantly different between the jugular and femoral venous access groups. However, the 1st attempt EMB procedural time by non-expert operators was longer when using the femoral approach, especially in cases involving a larger right atrium diameter.",2019,"However, the 1st attempt EMB procedural time by non-expert operators was longer when using the femoral approach, especially in cases involving a larger right atrium diameter.","['49 consecutive patients requiring EMB (3.9 attempts/patient) were enrolled (the jugular group: 23, the femoral group: 26), and 156 myocardial samples (3.2 samples/patient) were obtained', 'From February 2014 to May 2016, consecutive patients requiring EMB']","['EMB', 'Endomyocardial biopsy (EMB']","['EMB times and safety', 'complication rates', 'femoral access, non-expert operators, and larger right atrium', 'total time spent in acquiring EMB from the right ventricular septum between the jugular and femoral vein access groups', 'Total biopsy time', 'procedural time of endomyocardial biopsy', 'total biopsy procedural time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy (procedure)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0225844', 'cui_str': 'Right Atrium'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0225870', 'cui_str': 'Interventricular septum structure'}, {'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy (procedure)'}]",49.0,0.0318315,"However, the 1st attempt EMB procedural time by non-expert operators was longer when using the femoral approach, especially in cases involving a larger right atrium diameter.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Nakano', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Niwa', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Division of Biostatistics, Clinical Research Center, Aichi Medical University, Nagakute, Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Waseda', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan. waseda-circ@umin.ac.jp.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Aichi, Japan.'}]",Heart and vessels,['10.1007/s00380-018-1298-y'] 1261,30489104,Smoking cessation intervention trial outcomes for sexual and gender minority young adults.,"OBJECTIVE Sexual and gender minority (SGM) individuals are more likely to smoke than are non-SGM individuals. It is unclear whether smoking cessation interventions for young adults are effective in the SGM population. The purpose of this study was to compare smoking cessation, other health risk behaviors, and intervention usability between SGM and non-SGM young adult smokers participating in a digital smoking cessation intervention trial. METHODS Young adult smokers ( N = 500; 135 SGM) were assigned to a 90-day Facebook smoking cessation intervention (treatment) or referred to Smokefree.gov (control). Intervention participants were assigned to private Facebook groups tailored to their readiness to quit smoking. Participants reported their smoking status and other health risk behaviors at baseline, 3, 6, and 12 months. Usability of the intervention (i.e., perceptions of the intervention and treatment engagement) was assessed in the intervention group at 3 months. RESULTS Smoking cessation and intervention usability did not significantly differ between SGM participants and non-SGM participants. A greater proportion of SGM participants were at high risk for physical inactivity over the 12-month follow-up period (odds ratio [OR] = 1.55, p = .005). CONCLUSION SGM and non-SGM young adult smokers did not differ in their smoking cessation rates, perceptions of, or engagement in a digital intervention. Health risk behavior patterns were mostly similar; however, the disparity in physical activity between SGM and non-SGM smokers widened over time. Tailored interventions for SGM young adult smokers could increase focus on SGM experiences that can underlie multiple health risk behaviors, such as discrimination and the normativity of smoking. (PsycINFO Database Record (c) 2018 APA, all rights reserved).",2019,"CONCLUSION SGM and non-SGM young adult smokers did not differ in their smoking cessation rates, perceptions of, or engagement in a digital intervention.","['SGM young adult smokers', 'young adult smokers', 'sexual and gender minority young adults', 'young adults', 'Sexual and gender minority', 'young adult smokers participating in a digital smoking cessation intervention trial', 'Young adult smokers ( N = 500; 135 SGM']","['90-day Facebook smoking cessation intervention (treatment) or referred to Smokefree.gov (control', 'private Facebook groups tailored to their readiness to quit smoking', 'SGM and non-SGM']","['smoking status and other health risk behaviors', 'physical inactivity', 'Health risk behavior patterns', 'Smoking cessation and intervention usability']","[{'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4505097', 'cui_str': 'Health Risk Behaviors'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0137882,"CONCLUSION SGM and non-SGM young adult smokers did not differ in their smoking cessation rates, perceptions of, or engagement in a digital intervention.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Humfleet', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000698'] 1262,30612116,"Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial.","OBJECTIVES Cyclophosphamide induction regimens are effective for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), but are associated with infections, malignancies and infertility. Mycophenolate mofetil (MMF) has shown high remission rates in small studies of AAV. METHODS We conducted a randomised controlled trial to investigate whether MMF was non-inferior to cyclophosphamide for remission induction in AAV. 140 newly diagnosed patients were randomly assigned to MMF or pulsed cyclophosphamide. All patients received the same oral glucocorticoid regimen and were switched to azathioprine following remission. The primary endpoint was remission by 6 months requiring compliance with the tapering glucocorticoid regimen. Patients with an eGFR <15 mL/min were excluded from the study. RESULTS At baseline, ANCA subtype, disease activity and organ involvement were similar between groups. Non-inferiority was demonstrated for the primary remission endpoint, which occurred in 47 patients (67%) in the MMF group and 43 patients (61%) in the cyclophosphamide group (risk difference 5.7%, 90% CI -7.5% to 19%). Following remission, more relapses occurred in the MMF group (23 patients, 33%) compared with the cyclophosphamide group (13 patients, 19%) (incidence rate ratio 1.97, 95% CI 0.96 to 4.23, p=0.049). In MPO-ANCA patients, relapses occurred in 12% of the cyclophosphamide group and 15% of the MMF group. In PR3-ANCA patients, relapses occurred in 24% of the cyclophosphamide group and 48% of the MMF group. Serious infections were similar between groups (26% MMF group, 17% cyclophosphamide group) (OR 1.67, 95% CI 0.68 to 4.19, p=0.3). CONCLUSION MMF was non-inferior to cyclophosphamide for remission induction in AAV, but resulted in higher relapse rate. TRIAL REGISTRATION NUMBER NCT00414128.",2019,"Following remission, more relapses occurred in the MMF group (23 patients, 33%) compared with the cyclophosphamide group (13 patients, 19%) (incidence rate ratio 1.97, 95% CI 0.96 to 4.23, p=0.049).","['ANCA-associated vasculitis', '140 newly diagnosed patients', 'Patients with an eGFR']","['glucocorticoid', 'Mycophenolate mofetil versus cyclophosphamide', 'cyclophosphamide', 'Mycophenolate mofetil (MMF', 'MMF', 'PR3-ANCA', 'azathioprine', 'Cyclophosphamide induction regimens', 'MMF or pulsed cyclophosphamide']","['Serious infections', 'relapses', 'ANCA subtype, disease activity and organ involvement', 'remission by 6 months requiring compliance']","[{'cui': 'C2717865', 'cui_str': 'Pauci-Immune Vasculitis'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",140.0,0.18704,"Following remission, more relapses occurred in the MMF group (23 patients, 33%) compared with the cyclophosphamide group (13 patients, 19%) (incidence rate ratio 1.97, 95% CI 0.96 to 4.23, p=0.049).","[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Hiemstra', 'Affiliation': 'School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Ballarin', 'Affiliation': 'Department of Nephrology, Fundació Puigvert, Barcelona, Spain.'}, {'ForeName': 'Daniel Engelbert', 'Initials': 'DE', 'LastName': 'Blockmans', 'Affiliation': 'Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brogan', 'Affiliation': 'Department of Paediatric Rheumatology, University College London Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Cid', 'Affiliation': ""Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona, Institut d'investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dahlsveen', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Janak', 'Initials': 'J', 'LastName': 'de Zoysa', 'Affiliation': 'Renal Service, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Georgína', 'Initials': 'G', 'LastName': 'Espigol-Frigolé', 'Affiliation': ""Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona, Institut d'investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Department of Rheumatology, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Department of Renal Medicine, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Vaglio', 'Affiliation': ""Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Firenze, Firenze, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Departments of Medicine and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Walsh', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Department of Renal Medicine, Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'Institute of Clinical Sciences, University of Birmingham, Birmingham, UK l.harper@bham.ac.uk l.harper@bham.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2018-214245'] 1263,31253718,Evidence that an intervention weakens the relationship between adolescent electronic cigarette use and tobacco smoking: a 24-month prospective study.,"BACKGROUND The electronic cigarette (e-cigarette) use to subsequent smoking relationship in adolescents has received much attention. Whether an intervention to reduce smoking initiation attenuated this relationship was assessed. METHOD Data were from 3994 adolescent never smokers (aged 13-14 years at baseline) as part of a cluster randomised controlled trial. Self-report measures of smoking, e-cigarette use and covariates were assessed and used to predict ever smoked cigarettes, any recent tobacco smoking and regularly smoked cigarettes at 24-month follow-up. RESULTS Baseline ever use of e-cigarettes was associated with ever smoked cigarettes (OR=4.03, 95% CI 3.33 to 4.88; controlling for covariates, OR=2.78, 95% CI 2.20 to 3.51), any recent tobacco smoking (OR=3.38, 95% CI 2.72 to 4.21; controlling for covariates, OR=2.17, 95% CI 1.76 to 2.69) and regularly smoked cigarettes (OR=3.60, 95% CI 2.35 to 5.51; controlling for covariates, OR=1.27, 95% CI 1.17 to 1.39) at follow-up. For ever smoked cigarettes only, the impact of e-cigarette use was attenuated in the intervention (OR=1.83) compared with control (OR=4.53) condition. For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)). CONCLUSIONS This is one of the first studies to show that e-cigarette use was robustly associated with measures of smoking over 24 months and the first to show an intervention to attenuate the relationship. Further research with a broader age range of adolescents is required.",2020,"For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)). ",['Data were from 3994 adolescent never smokers (aged 13-14 years at baseline'],[],"['adolescent electronic cigarette use and tobacco smoking', 'regularly smoked cigarettes', 'recent tobacco smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]",,0.0288669,"For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)). ","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK m.t.conner@leeds.ac.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grogan', 'Affiliation': 'Department of Psychology, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Simms-Ellis', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Flett', 'Affiliation': 'Faculty of Health Sciences, Staffordshire University, Staffordshire, UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Sykes-Muskett', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cowap', 'Affiliation': 'Faculty of Health Sciences, Staffordshire University, Staffordshire, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Armitage', 'Affiliation': 'Psychology, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Schmitt', 'Affiliation': 'Academic Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Torgerson', 'Affiliation': 'Education, Durham University, Durham, Durham, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Institute of Health Sciences, University of York, York, North Yorkshire, UK.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054905'] 1264,31673858,"Incidence of postoperative pain after canal shaping by using Reciproc and Twisted File Adaptive systems: a prospective, randomized clinical trial.","OBJECTIVES The aim of this prospective clinical trial was to investigate the incidence of postoperative pain after initial root canal treatment using Twisted File Adaptive (TFA) and Reciproc systems. MATERIALS AND METHODS A total of sixty-four previously initiated or necrotic posterior teeth were randomly assigned to two groups based on the rotary system used; TFA (SybronEndo, Orange, Ca) (n = 35) and Reciproc (VDW, Munich, Germany) (n = 29). All teeth were treated in a single visit. Patients were contacted to assess the level of postoperative pain on a visual analog scale after treatment by 6 h, 24 h, 48 h, 72 h, and 1 week. Patients were also asked to report if any medication was taken during the follow-up period. The postoperative pain scores were analyzed by Mann-Whitney test with respect to follow-up interval at a significance level of 0.05. RESULTS Patients treated with TFA reported significantly lower postoperative pain levels at 24 h, 48 h, and 72 h compared with those in Reciproc group (p < 0.01). There were no significant differences between the two groups at 6 h and 1-week follow-up intervals (p > 0.05). About 11% (TFA) and 24% (Reciproc) of the treated patients took analgesics, but none of them took antibiotics during the follow-up period. CONCLUSIONS The tested rotary systems induced postoperative pain after root canal treatment. The TFA system was found to induce less pain scores compared with the Reciproc system after the treatment by 24 h, 48 h, and 72 h. CLINICAL RELEVANCE The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.",2020,The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.,['A total of sixty-four previously initiated or necrotic posterior teeth'],"['initial root canal treatment using Twisted File Adaptive (TFA) and Reciproc systems', 'rotary system used; TFA (SybronEndo, Orange, Ca) (n = 35) and Reciproc (VDW, Munich, Germany', 'canal shaping by using Reciproc and Twisted File Adaptive systems', 'TFA']","['postoperative pain', 'pain scores', 'postoperative pain scores', 'level of postoperative pain on a visual analog scale', 'level of postoperative pain', 'postoperative pain levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",64.0,0.0357202,The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.,"[{'ForeName': 'Taher', 'Initials': 'T', 'LastName': 'AlOmari', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Ghadah', 'Initials': 'G', 'LastName': 'AlThobiti', 'Affiliation': 'Specialized Dental Center, Department of Endodontics, Ministry of Health, Taif, Saudi Arabia.'}, {'ForeName': 'Sabri', 'Initials': 'S', 'LastName': 'AlThobaiti', 'Affiliation': 'King Abdulaziz Medical City, Ministry of National Guard-Health Affairs, Jeddah, Saudi Arabia.'}, {'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'AlOufi', 'Affiliation': 'Department of Endodontics, Dental Specialist Center, King Fahad Hospital, Ministry of Health, Medina, Saudi Arabia.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Masuadi', 'Affiliation': 'Department of Medical Education, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Jamleh', 'Affiliation': 'Department of Medical Education, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. aojamleh@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-019-03106-5'] 1265,31670998,Intramuscular 17α-hydroxyprogesterone caproate to decrease preterm delivery in women with placenta praevia: a randomised controlled trial.,"We tested the hypothesis that 17α-hydroxyprogesterone caproate (17α-OHP-C) may decrease preterm delivery (PTD) in women with placenta praevia. This was a randomised controlled trial included 114 women with placenta praevia (between 24 and 28 weeks). They were randomly assigned to group I (17α-OHP-C) who received weekly injection of 17α-OHP-C (250 mg/IM) till completing 37 weeks' gestation or group II (Non 17α-OHP-C). The percentage of placenta praevia patients went into PTD in the 17α-OHP-C group was significantly less in comparison to the PTD in the Non 17α-OHP-C group (∼37% vs. 63.5%, p  = .004). Furthermore, the mean gestational age was significantly longer (36.7 ± 0.7 vs. 34.9 ± 1.2 weeks, p  < .000), the mean number of bleeding attacks was significantly less and the mean birth weight was significantly higher (2841 ± 159 vs. 2561 ± 168 g, p  < .000). In conclusion, maintenance tocolysis with intramuscular 17α-OHP-C in placenta praevia women appears beneficial in decreasing the number of bleeding attacks, the percentage of PTD and the neonatal ICU admission.IMPACT STATEMENT What is already known on this subject? Over the last two decades, a large number of studies indicated that placenta praevia is a major risk factor for preterm labour and prematurity with its neonatal complications. Increasing caesarean section rates had proportionally increased the incidence of placenta praevia. What do the results of this study add? Up to now, the effective and safe tocolytic agent among these patients is not established. The results of this study (prospective, randomised and controlled with calculated sample size) added a considerable support for hydroxyprogesterone caproate as an effective, safe and cheap tocolytic agent with excellent patient compliance. What are the implications of these findings for clinical practice and/or further research? Our findings may prompt researchers to conduct a large multicentre study to evaluate the prophylactic use of hydroxyprogesterone caproate to decrease preterm labour due to placenta praevia.",2020,"The percentage of placenta praevia patients went into PTD in the 17α-OHP-C group was significantly less in comparison to the PTD in the Non 17α-OHP-C group (∼37% vs. 63.5%, ","['placenta praevia women', '114 women with placenta praevia (between 24 and 28\u2009weeks', 'women with placenta praevia']","['IMPACT', 'hydroxyprogesterone caproate', '17α-OHP-C', '17α-hydroxyprogesterone caproate (17α-OHP-C', 'Intramuscular 17α-hydroxyprogesterone caproate']","['number of bleeding attacks', 'mean birth weight', 'preterm delivery', 'mean gestational age', 'mean number of bleeding attacks', 'incidence of placenta praevia', 'preterm delivery (PTD', 'Increasing caesarean section rates']","[{'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0044971', 'cui_str': 'hydroxyprogesterone caproate (USP)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]",114.0,0.135369,"The percentage of placenta praevia patients went into PTD in the 17α-OHP-C group was significantly less in comparison to the PTD in the Non 17α-OHP-C group (∼37% vs. 63.5%, ","[{'ForeName': 'Ayman H', 'Initials': 'AH', 'LastName': 'Shaamash', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, Woman's Health Hospital, Assiut University, Assiut, Egypt.""}, {'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, Woman's Health Hospital, Assiut University, Assiut, Egypt.""}, {'ForeName': 'Khalid M', 'Initials': 'KM', 'LastName': 'Attyia', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, Woman's Health Hospital, Assiut University, Assiut, Egypt.""}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1645099'] 1266,31595955,Growth During Infancy and Early Childhood and Its Association With Metabolic Risk Biomarkers at 11.5 Years of Age.,"The evidence that fetal life and early infancy are ""critical"" or ""sensitive"" ages for later development of cardiometabolic disease is based on flawed methods for comparing different age periods. Moreover, most previous studies have limited their focus to weight gain, rather than growth in length/height or body mass index (weight (kg)/height (m)2). We undertook a secondary analysis of data from the Promotion of Breastfeeding Intervention Trial (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, that had repeated measurements of weight and length/height taken from birth to 11.5 years of age. We used mixed-effects linear models to analyze associations of changes in standardized weight, length/height, and body mass index during 5 age periods (conception to birth, birth to age 3 months, ages 3-12 months, ages 12 months-6.5 years, and ages 6.5-11.5 years) with fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin at age 11.5 years. We observed strong associations between the metabolic markers and all 3 growth measures, with the largest magnitudes being observed during the latest age period (ages 6.5-11.5 years) and negligible associations during gestation and the first year of life. Later age periods appear more ""sensitive"" than earlier periods to the adverse metabolic association with rapid growth in childhood.",2020,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","['PROBIT (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, with repeated measures of weight and length/height from birth to 11.5 years of age', 'at age 11.5 years']",[],"['standardized weight, length/height, and BMI', 'fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2930714', 'cui_str': 'Republic of Belarus'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",,0.020093,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","[{'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, Bristol, United Kingdom.'}, {'ForeName': 'Izzuddin M', 'Initials': 'IM', 'LastName': 'Aris', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Seungmi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Author affiliations: Department of Pediatrics, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}]",American journal of epidemiology,['10.1093/aje/kwz234'] 1267,30587088,Recruitment of Schools for Intervention Research to Reduce Health Disparities for Sexual and Gender Minority Students.,"Recruiting schools for intervention research can be daunting. This study examined the experiences of researchers recruiting public high schools for a randomized controlled trial to reduce suicide disparities for sexual and gender minority (SGM) youth by implementing evidence-based strategies to enhance school environments. We enrolled 42 schools throughout New Mexico between August 2016 and April 2017. Based on qualitative analysis of recruitment efforts, three groups of factors affected enrollment: (1) non-SGM-specific factors, (2) SGM-specific factors, and (3) facilitating factors. Non-SGM-specific factors negatively impacted the willingness or ability to participate (e.g., demanding staff workloads and beliefs that ""outsiders"" should not assist with school-based interventions). Notable SGM-specific factors centered on influences in socially conservative community environments and beliefs that schools lacked SGM students. Advocacy, leveraging relationships, and persistence were facilitating factors for overcoming recruitment obstacles. Our findings have implications for researchers and school nurses interested in school-based interventions, especially those focused on SGM youth.",2018,"Non-SGM-specific factors negatively impacted the willingness or ability to participate (e.g., demanding staff workloads and beliefs that ""outsiders"" should not assist with school-based interventions).","['Sexual and Gender Minority Students', 'We enrolled 42 schools throughout New Mexico between August 2016 and April 2017']",[],[],"[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],[],42.0,0.0188143,"Non-SGM-specific factors negatively impacted the willingness or ability to participate (e.g., demanding staff workloads and beliefs that ""outsiders"" should not assist with school-based interventions).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Shattuck', 'Affiliation': '1 Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}, {'ForeName': 'Janie Lee', 'Initials': 'JL', 'LastName': 'Hall', 'Affiliation': '1 Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': '3 The Trevor Project, Los Angeles, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Greenberg', 'Affiliation': '1 Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Peñaloza', 'Affiliation': '5 Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': '5 Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Willging', 'Affiliation': '1 Behavioral Health Research Center of the Southwest, Pacific Institute for Research and Evaluation, Albuquerque, NM, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840518820103'] 1268,30596538,The impact of a planned health educational program on the compliance and knowledge of Jordanian pregnant women with anemia.,"Iron deficiency anemia is a major public health problem among pregnant women in developing countries. This study aimed to use a randomized controlled trial to evaluate the effectiveness of a health information package in Jordanian anemic pregnant women's knowledge regarding anemia, compliance with iron supplementation, and hemoglobin level. Two hundred pregnant anemic women were recruited and randomly assigned into intervention or control group from April to July 2016. The intervention group received a video presentation of the Health Information Package Program (HIPP), narrated by a midwife, combined with PowerPoint slides to educate women about anemia in pregnancy. The participants in the control group received standard care in antenatal clinics, including iron supplementation. No significant differences were observed between the groups in age, gestational age, health problems, and total income. Only education and source of information differed significantly between the groups. Women in the intervention group had higher scores on the compliance checklist, knowledge, food selection ability, and hemoglobin level than women in the control group. The health information package program was effective. Policymakers should adopt a health information package program and apply it as a comprehensive national strategy for the prevention of anemia during pregnancy.",2019,"Women in the intervention group had higher scores on the compliance checklist, knowledge, food selection ability, and hemoglobin level than women in the control group.","['Jordanian pregnant women with anemia', 'Two hundred pregnant anemic women', ""Jordanian anemic pregnant women's"", 'pregnant women in developing countries']","['video presentation of the Health Information Package Program (HIPP), narrated by a midwife, combined with PowerPoint slides', 'standard care in antenatal clinics, including iron supplementation', 'health information package', 'planned health educational program']","['knowledge regarding anemia, compliance with iron supplementation, and hemoglobin level', 'compliance checklist, knowledge, food selection ability, and hemoglobin level']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011750', 'cui_str': 'Under-Developed Nations'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0016488', 'cui_str': 'Food Selection'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",200.0,0.0522715,"Women in the intervention group had higher scores on the compliance checklist, knowledge, food selection ability, and hemoglobin level than women in the control group.","[{'ForeName': 'Sanaa', 'Initials': 'S', 'LastName': 'Abujilban', 'Affiliation': 'a Department of Maternal, Child and Family Health Nursing , Hashemite University College of Nursing , Zarqa , Jordan.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Hatamleh', 'Affiliation': 'b Department of Nursing , Jordan University of Science and Technology , Irbid , Jordan.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Al-Shuqerat', 'Affiliation': ""c Department of Nursing , Al-Hussein Bin Talal University , Ma'an , Jordan.""}]",Women & health,['10.1080/03630242.2018.1549644'] 1269,31605663,Exercise-induced attenuation of treatment side-effects in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy: a randomised controlled trial.,"OBJECTIVES (i) To assess whether exercise training attenuates the adverse effects of treatment in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy (ADT), and (ii) to examine whether exercise-induced improvements are sustained after the withdrawal of supervised exercise. PATIENTS AND METHODS In all, 50 patients with prostate cancer scheduled for ADT were randomised to an exercise group (n = 24) or a control group (n = 26). The exercise group completed 3 months of supervised aerobic and resistance exercise training (twice a week for 60 min), followed by 3 months of self-directed exercise. Outcomes were assessed at baseline, 3- and 6-months. The primary outcome was difference in fat mass at 3-months. Secondary outcomes included: fat-free mass, cardiopulmonary exercise testing variables, QRISK ® 2 (ClinRisk Ltd, Leeds, UK) score, anthropometry, blood-borne biomarkers, fatigue, and quality of life (QoL). RESULTS At 3-months, exercise training prevented adverse changes in peak O 2 uptake (1.9 mL/kg/min, P = 0.038), ventilatory threshold (1.7 mL/kg/min, P = 0.013), O 2 uptake efficiency slope (0.21, P = 0.005), and fatigue (between-group difference in Functional Assessment of Chronic Illness Therapy-Fatigue score of 4.5 points, P = 0.024) compared with controls. After the supervised exercise was withdrawn, the differences in cardiopulmonary fitness and fatigue were not sustained, but the exercise group showed significantly better QoL (Functional Assessment of Cancer Therapy-Prostate difference of 8.5 points, P = 0.034) and a reduced QRISK2 score (-2.9%, P = 0.041) compared to controls. CONCLUSION A short-term programme of supervised exercise in patients with prostate cancer beginning ADT results in sustained improvements in QoL and cardiovascular events risk profile.",2020,A short-term programme of supervised exercise for prostate cancer patients beginning ADT results in sustained improvements in QoL and cardiovascular event risk profile.,"['newly diagnosed prostate cancer patients beginning androgen deprivation therapy', 'Fifty prostate cancer patients scheduled for ADT', 'prostate cancer patients beginning ADT', 'newly diagnosed prostate cancer patients beginning androgen deprivation therapy (ADT), and 2']","['exercise group', 'Exercise-induced attenuation', 'exercise training', 'supervised aerobic and resistance exercise training', 'supervised exercise']","['fat-free mass, cardiopulmonary exercise testing variables, QRISK2 score, anthropometry, blood-borne biomarkers, fatigue, and quality of life (QoL', 'fat mass', 'ventilatory threshold', 'cardiopulmonary fitness and fatigue', 'higher QoL', 'reduced QRISK2 score', 'oxygen uptake efficiency slope', 'QoL and cardiovascular event risk profile', 'adverse changes in peak oxygen uptake', 'fatigue']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",,0.140773,A short-term programme of supervised exercise for prostate cancer patients beginning ADT results in sustained improvements in QoL and cardiovascular event risk profile.,"[{'ForeName': 'Wilphard', 'Initials': 'W', 'LastName': 'Ndjavera', 'Affiliation': 'Department of Urology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Orange', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alasdair F', 'Initials': 'AF', 'LastName': ""O'Doherty"", 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Leicht', 'Affiliation': 'Sport and Exercise Science, College of Healthcare Sciences, James Cook University, Townsville, QLD, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rochester', 'Affiliation': 'Department of Urology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mills', 'Affiliation': 'Department of Urology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Saxton', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}]",BJU international,['10.1111/bju.14922'] 1270,31653265,Cervical trans-spinal direct current stimulation: a modelling-experimental approach.,"BACKGROUND Trans-spinal direct current stimulation (tsDCS) is a non-invasive technique with promising neuromodulatory effects on spinal cord (SC) circuitry. Computational studies are essential to guide effective tsDCS protocols for specific clinical applications. This study aims to combine modelling and experimental studies to determine the electrode montage that maximizes electric field (E-field) delivery during cervical tsDCS. METHODS Current and E-field distributions in the cervical SC were predicted for four electrode montages in a human realistic model using computational methods. A double-blind crossover and randomized exploratory study was conducted using the montage that maximized E-field delivery. tsDCS was applied for 15 min in 10 healthy subjects (anodal, cathodal, sham, with polarity assigned to the cervical electrode), with a current intensity of 2.5 mA, resulting in a total current charge density delivery of 90 mC/cm 2 . Upper limb motor (transcranial magnetic stimulation) and sensory evoked potentials (MEP, SEP), M-waves, H-reflex and F-wave responses were analysed. Central and peripheral conduction times were determined using MEP. Repeated measures ANOVA and Friedman test were used for statistical analysis (significance level α = 0.05). RESULTS All montages presented higher current density and E-field magnitudes in the cervical SC region between the electrodes. However, electrodes at C3 and T3 spinous processes (C3-T3) originated the highest E-field magnitude (0.50 V/m). Using C3-T3 montage we observed significant changes in N9 SEP latency (p = 0.006), but significance did not persist in pairwise comparisons (sham-anodal: p = 0.022; sham-cathodal: p = 0.619; anodal-cathodal: p = 0.018; α = 0.017, Bonferroni corrected). MEP latency and central motor conduction time (CMCT) modified significantly on stimulation (p = 0.007 and p = 0.015, respectively). In addition, pairwise comparisons confirmed significant differences between sham and cathodal conditions after Bonferroni correction for MEP latency (sham-anodal: p = 0.868; sham-cathodal: p = 0.011; anodal-cathodal: p = 0.023) and CMCT (sham-anodal: p = 0.929; sham-cathodal: p = 0.010; anodal-cathodal: p = 0.034). CONCLUSIONS Computational models predicted higher E-field delivery in the cervical SC for the C3-T3 montage. Polarity-dependent effects in motor responses were reported using this montage consistent with spinal motor modulation. tsDCS experimental protocol designs should be guided by modelling studies to improve effectiveness.",2019,"MEP latency and central motor conduction time (CMCT) modified significantly on stimulation (p = 0.007 and p = 0.015, respectively).",['10 healthy subjects'],"['Trans-spinal direct current stimulation (tsDCS', 'Cervical trans-spinal direct current stimulation', 'Bonferroni correction for MEP latency (sham-anodal', 'tsDCS', 'C3-T3', 'CMCT']","['Upper limb motor (transcranial magnetic stimulation) and sensory evoked potentials (MEP, SEP), M-waves, H-reflex and F-wave responses', 'MEP latency and central motor conduction time (CMCT', 'N9 SEP latency', 'Central and peripheral conduction times']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current (physical force)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0110177', 'cui_str': '1-cyclohexyl-3-(2-(4-morpholinyl)ethyl)carbodiimide tosylate'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0015214', 'cui_str': 'Evoked Potentials'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0110177', 'cui_str': '1-cyclohexyl-3-(2-(4-morpholinyl)ethyl)carbodiimide tosylate'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",90.0,0.145767,"MEP latency and central motor conduction time (CMCT) modified significantly on stimulation (p = 0.007 and p = 0.015, respectively).","[{'ForeName': 'Sofia Rita', 'Initials': 'SR', 'LastName': 'Fernandes', 'Affiliation': 'Instituto de Fisiologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Avenida Professor Egas Moniz, 1649-028, Lisbon, Portugal. srcfernandes@fc.ul.pt.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': 'Instituto de Fisiologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Avenida Professor Egas Moniz, 1649-028, Lisbon, Portugal.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salvador', 'Affiliation': 'Neuroelectrics, Avinguda Tibidabo, 47 bis, 08035, Barcelona, Spain.'}, {'ForeName': 'Pedro Cavaleiro', 'Initials': 'PC', 'LastName': 'Miranda', 'Affiliation': 'Instituto de Biofísica e Engenharia Biomédica, Faculdade de Ciências, Universidade de Lisboa, Campo Grande, 1749-016, Lisbon, Portugal.'}, {'ForeName': 'Mamede', 'Initials': 'M', 'LastName': 'de Carvalho', 'Affiliation': 'Instituto de Fisiologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Avenida Professor Egas Moniz, 1649-028, Lisbon, Portugal.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0589-6'] 1271,29926433,The Effect of Educational Intervention Based on PRECEDE Model on Promoting Skin Cancer Preventive Behaviors in High School Students.,"School-based education programs can be an effective way of educating adolescents about the dangers of exposure to sunlight and about preventive measures against this exposure and its relation to skin cancer. The aim of this study is to survey the effect of educational intervention based on the PRECEDE model on promoting skin cancer preventive behaviors in high school students of Fasa City, Fars Province, Iran. In this quasi-experimental study, 300 students (150 in experimental group and 150 in control group) in Fasa City, Fars Province, Iran, were selected in 2016-2017. The educational intervention for the experimental group consisted of six training sessions. A questionnaire consisting of demographic information, PRECEDE constructs (knowledge, attitude, self-efficacy, enabling factors, and social support), was used to measure skin cancer preventive behaviors before and 4 months after the intervention. Data were analyzed using SPSS 22 and paired t test, independent t test, and chi-square test at a significance level of p < 0.05. The mean age of the students was 16.05 ± 1.76 years in the experimental group and 16.20 ± 1.71 years in the control group. Four months after the intervention, the experimental group showed a significant increase in the knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors compared to the control group. This study showed the effectiveness of the intervention based on the PRECEDE constructs in adoption of skin cancer preventive behaviors in 4 months post-intervention in students. Hence, this model can act as a framework for designing and implementing educational intervention for the prevention of skin cancer.",2019,"Four months after the intervention, the experimental group showed a significant increase in the knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors compared to the control group.","['The mean age of the students was 16.05\u2009±\u20091.76\xa0years in the experimental group and 16.20\u2009±\u20091.71\xa0years in the control group', 'skin cancer preventive behaviors in 4\xa0months post-intervention in students', 'High School Students', '300 students (150 in experimental group and 150 in control group) in Fasa City, Fars Province, Iran, were selected in 2016-2017', 'high school students of Fasa City, Fars Province, Iran']","['Educational Intervention', 'educational intervention', 'School-based education programs']","['knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors', 'Skin Cancer Preventive Behaviors', 'skin cancer preventive behaviors']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0014024', 'cui_str': 'Enabling Factors'}, {'cui': 'C0037438'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",300.0,0.0173,"Four months after the intervention, the experimental group showed a significant increase in the knowledge, attitude, self-efficacy, enabling factors, social support, and skin cancer preventive behaviors compared to the control group.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khani Jeihooni', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran. khani_1512@yahoo.com.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Moradi', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1376-y'] 1272,30575682,High-salt intake affects sublingual microcirculation and is linked to body weight change in healthy volunteers: a randomized cross-over trial.,"BACKGROUND The pathophysiology of salt-sensitive hypertension remains uncertain, but may involve microvascular alterations. High-salt intake decreases microvascular density in hypertensive patients, but due to lack of studies in normotensive patients the causal pathway remains unclear. We studied whether high-salt intake decreases sublingual microvascular density in normotensive individuals and assessed the influence of body weight on changes in microvascular density. METHODS In an open label randomized cross-over trial 18 healthy men were included to study the effect of a 2-week high-salt (>12 g/day) and low-salt (<3 g/day) diet on microvascular (diameter <20 μm) density with sublingual sidestream darkfield imaging. We used sublingual nitroglycerin (NTG) to recruit microvessels. RESULTS There was no significant difference in microvascular density between diets (0.96 ± 3.88 mm/mm; P = 0.31, following NTG; and -0.03 ± 1.64 mm/mm; P = 0.95, without NTG). Increased salt intake was correlated with a decrease in microvascular density following NTG (r = -0.47; P = 0.047), but not without NTG (r = 0.06; P = 0.800). The decrease in microvascular density following high-salt intake was significantly larger for those with a large change in body weight as compared with those with a small changer in body weight (-0.79 ± 1.35 and 0.84 ± 1.56 mm/mm respectively, P = 0.031). CONCLUSION We demonstrate in healthy volunteers that higher salt intake is correlated with decreased sublingual microvascular density following administration of NTG and; larger changes in body weight following high-salt intake coincide with a larger decrease in microvascular density. Changes in microvascular density occurred without blood pressure effects, indicating that high-salt load as such contributes to microvascular changes, and may precede hypertension development.",2019,"There was no significant difference in microvascular density between diets (0.96 ± 3.88 mm/mm; P = 0.31, following NTG; and -0.03 ± 1.64 mm/mm; P = 0.95, without NTG).","['normotensive individuals', '18 healthy men', 'healthy volunteers', 'hypertensive patients']","['NTG', 'High-salt intake', 'high-salt intake', 'low-salt (<3\u200ag/day) diet on microvascular (diameter <20\u200aμm) density with sublingual sidestream darkfield imaging', 'NTG ', 'sublingual nitroglycerin (NTG']","['microvascular density', 'Increased salt intake', 'body weight', 'sublingual microvascular density']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}]",18.0,0.0522311,"There was no significant difference in microvascular density between diets (0.96 ± 3.88 mm/mm; P = 0.31, following NTG; and -0.03 ± 1.64 mm/mm; P = 0.95, without NTG).","[{'ForeName': 'Nienke M G', 'Initials': 'NMG', 'LastName': 'Rorije', 'Affiliation': 'Section Nephrology.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rademaker', 'Affiliation': 'Section Nephrology.'}, {'ForeName': 'Esmee M', 'Initials': 'EM', 'LastName': 'Schrooten', 'Affiliation': 'Section Nephrology.'}, {'ForeName': 'Rosa D', 'Initials': 'RD', 'LastName': 'Wouda', 'Affiliation': 'Section Nephrology.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Homan Van Der Heide', 'Affiliation': 'Section Nephrology.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'Van Den Born', 'Affiliation': 'Section Vascular Medicine, Department of Internal Medicine, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Section Nephrology.'}]",Journal of hypertension,['10.1097/HJH.0000000000002015'] 1273,30293128,Functional Behavior-Based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children with Autism Spectrum Disorder: A Randomized Controlled Trial.,"Children with autism spectrum disorder (ASD) experience obsessions and compulsions similar to those specified in DSM-5 for obsessive compulsive disorder yet little controlled research exists on treating these behaviours. Thirty-seven children (7-13 years old) were randomly assigned to a 9-week functional behavior-based cognitive behavior therapy (Fb-CBT) or Treatment As Usual. Independent assessors administered measures pre- and post-treatment and at 6-months. Two primary outcome measures indicated statistically significant differences between groups, with large corrected effect sizes (Hedge's g = 1.00 and 1.15, respectively). This is the first known RCT to exclusively treat obsessive compulsive behaviors (OCBs) in children and youth with high functioning (IQ ≥ 70) ASD, and suggests that Fb-CBT treatment shows promise in decreasing these behaviors and improving quality of life. Trial Registration This trial was registered with ClinicalTrials.gov (ID: NCT03123146).",2020,"Two primary outcome measures indicated statistically significant differences between groups, with large corrected effect sizes (Hedge's g = 1.00 and 1.15, respectively).","['Children with Autism', 'Thirty-seven children (7-13\xa0years old', 'Spectrum Disorder', 'Children with autism spectrum disorder (ASD', 'children and youth with high functioning (IQ\u2009≥\u200970) ASD']","['9-week functional behavior-based cognitive behavior therapy (Fb-CBT) or Treatment As Usual', 'Functional Behavior-Based Cognitive-Behavioral Therapy']",['Obsessive Compulsive Behavior'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}]",37.0,0.127394,"Two primary outcome measures indicated statistically significant differences between groups, with large corrected effect sizes (Hedge's g = 1.00 and 1.15, respectively).","[{'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Vause', 'Affiliation': 'Departments of Child and Youth Studies and Applied Disability Studies, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada. tvause@brocku.ca.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaksic', 'Affiliation': 'Department of Applied Disability Studies, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Neil', 'Affiliation': 'Department of Applied Disability Studies, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Frijters', 'Affiliation': 'Department of Child and Youth Studies, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Jackiewicz', 'Affiliation': 'Private Practice, Niagara Falls, ON, Canada.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Departments of Child and Youth Studies and Applied Disability Studies, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}]",Journal of autism and developmental disorders,['10.1007/s10803-018-3772-x'] 1274,32409277,Community perspectives on difference of sex development (DSD) diagnoses: A crowdsourced survey.,"INTRODUCTION AND OBJECTIVES Differences of sex development (DSD) engender ethical, social and psychosexual complexities that can complicate medical decision-making. We performed a web-based pilot study to estimate the utility value of a DSD diagnosis and to identify community concerns regarding DSD management. METHODS A cross-sectional survey was posted on Amazon's Mechanical Turk, an online crowdsourcing platform. Respondents were ≥18y and were randomized to receive information on one of three common DSD conditions: Congenital Adrenal Hyperplasia (CAH), Mixed Gonadal Dysgenesis (MGD), and Partial Androgen Insensitivity Syndrome (PAIS). Time trade-off methodology was used to estimate utility values. Likert scale and statement-ranking questions were used to assess respondent perceptions. RESULTS Of 1,628 respondents, median age was 34y; most respondents were parents (59.1%), white (77.1%), and previously unfamiliar with DSD (60.4%). The median overall utility value was 0.70 (IQR 0.50-0.90), similar to moderately severe chronic health conditions. Utility estimates varied based on the DSD scenario presented (0.80 CAH vs. 0.70 MGD vs. 0.80 PAIS, p = 0.0006), respondent gender (p < 0.0001), race (p = 0.002), religion (p = 0.005), and prior knowledge of DSD (p < 0.0001). Reported concerns included gender identity (23.4%), urinary function (20.5%) and surgical complications (17.4%). Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y. COMMENT Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results. Given the nature of this pilot study, the representation of families with children with DSD within the study is severely limited given the rarity of DSDs. This means that their opinions may be diluted by the large sample size. However, because utility values are classically estimated according to community opinions, the utility data presented should be taken to reflect that of the specific sample studied and is not reflective of that of families with a vested interest in such cases. CONCLUSIONS Community-based respondents perceived that DSD conditions were associated with a reduction in utility values (0.70-0.80), on par with moderately severe chronic health conditions. Estimates varied based on respondents' gender, race, religion and prior knowledge of DSD. Gender identity was the most concerning aspect for respondents.",2020,"Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y. COMMENT Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results.","[""A cross-sectional survey was posted on Amazon's Mechanical Turk, an online crowdsourcing platform"", 'families with children with DSD', '1,628 respondents']","['DSD conditions: Congenital Adrenal Hyperplasia (CAH), Mixed Gonadal Dysgenesis (MGD), and Partial Androgen Insensitivity Syndrome (PAIS']","['urinary function', 'median overall utility value', 'utility values', 'surgical complications']","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2930619', 'cui_str': 'Disorder of sexual differentiation'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C2930619', 'cui_str': 'Disorder of sexual differentiation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001627', 'cui_str': 'Congenital adrenal hyperplasia'}, {'cui': 'C0018055', 'cui_str': 'Mixed gonadal dysgenesis'}, {'cui': 'C0268301', 'cui_str': 'Reifenstein syndrome'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0455143,"Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y. COMMENT Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results.","[{'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Alkazemi', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Johnston', 'Affiliation': 'Department of Surgery, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Meglin', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Routh', 'Affiliation': 'Department of Surgery, Duke University School of Medicine, Durham, NC, USA. Electronic address: jonathan.routh@duke.edu.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.03.023'] 1275,30352036,"Immediate effect of mind sound resonance technique (MSRT - a yoga-based relaxation technique) on blood pressure, heart rate, and state anxiety in individuals with hypertension: a pilot study.","Background Mind sound resonance technique (MSRT) is a yoga-based relaxation technique. Previous studies on MSRT demonstrated its potential health-benefiting effects in both clinical and nonclinical population. Present study intended to assess the acute effect of MSRT intervention on blood pressure, heart rate (HR), and state anxiety in patients with essential hypertension (HTN). Methods Thirty participants (13 females) with HTN, within the age range 30-60 years (with mean±SD: 57.23±11.3 years), who visited SVYASA University campus to attend 1-week residential yoga program for HTN treatment, were considered for this study based on inclusion and exclusion criteria. All participants received a 4-day MSRT orientation sessions prior to the study. Each participant underwent 30-min session of both MSRT and supine rest (SR) on 2 successive days. Systolic and diastolic blood pressures, pulse rate, and state anxiety were measured before and immediately after both MSRT and SR sessions. Data were analyzed using SPSS version 16. Repeated-measure analysis of variance was applied to assess within-subjects changes. Results After MSRT session, significant decrease in systolic blood pressure (SBP), diastolic blood pressure (DBP), HR, and state anxiety was observed compared to baseline. Similarly, after SR session, significant changes were found in HR and state anxiety. No significant change was seen in SBP and DBP following SR compared to SR session; MSRT session showed significantly better improvement in SBP, DBP, HR, and state anxiety. Conclusion Present study demonstrated the usefulness of single session of MSRT in reducing blood pressure, HR, and state anxiety among individuals with HTN as compared to SR. These findings encourage the further studies with larger sample size and long-term intervention with a robust research design.",2018,"No significant change was seen in SBP and DBP following SR compared to SR session; MSRT session showed significantly better improvement in SBP, DBP, HR, and state anxiety.","['individuals with hypertension', 'Methods Thirty participants (13 females) with HTN, within the age range 30-60 years (with mean±SD: 57.23±11.3 years), who visited SVYASA University campus to attend 1-week residential yoga program for HTN treatment, were considered for this study based on inclusion and exclusion criteria', 'patients with essential hypertension (HTN']","['mind sound resonance technique (MSRT - a yoga-based relaxation technique', '4-day MSRT orientation sessions', ' Mind sound resonance technique (MSRT', 'MSRT and supine rest (SR', 'MSRT intervention', 'MSRT']","['systolic blood pressure (SBP), diastolic blood pressure (DBP), HR, and state anxiety', 'Systolic and diastolic blood pressures, pulse rate, and state anxiety', 'SBP and DBP', 'HR and state anxiety', 'blood pressure, heart rate (HR), and state anxiety', 'blood pressure, HR, and state anxiety', 'SBP, DBP, HR, and state anxiety', 'blood pressure, heart rate, and state anxiety']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0231881', 'cui_str': 'Resonance, function (observable entity)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035029', 'cui_str': 'Relaxation Technics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",30.0,0.0153467,"No significant change was seen in SBP and DBP following SR compared to SR session; MSRT session showed significantly better improvement in SBP, DBP, HR, and state anxiety.","[{'ForeName': 'Yuni', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'SVYASA University, Bengaluru, India.'}, {'ForeName': 'Kashinath G', 'Initials': 'KG', 'LastName': 'Metri', 'Affiliation': 'SVYASA University, Bengaluru, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'SVYASA University, Bengaluru, India.'}, {'ForeName': 'Nagaratna', 'Initials': 'N', 'LastName': 'Raghuram', 'Affiliation': 'Holistic Health Center, SVYASA University, Bengaluru, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2017-0177'] 1276,31650314,Evaluation of effect of warm local anesthetics on pain perception during dental injections in children: a split-mouth randomized clinical trial.,"OBJECTIVES The present study evaluates the efficacy of warm local anesthetic (37 °C) administration and injections of local anesthetics at room temperature (21 °C) in reducing pain during injections in children undergoing dental procedures. MATERIALS AND METHODS Enrolled for this split-mouth randomized clinical study were 100 children aged 5-8 years. Within the random crossover design selected for the study, each patient was randomly assigned to receive either a body or room temperature local anesthesia in the first session and the other local anesthesia on the second session. During the injection, the Wong-Baker Faces Pain Rating Scale was used as a subjective measure of discomfort, and heart rate as an objective measure. The Face, Legs, Arms, Cry, and Consolability (FLACC) scale was used to record the child's pain, based on the perception of the dental assistant. The data were analyzed using a Wilcoxon sign rank test and a paired t test. RESULTS Based on the score of the Wong-Baker Faces Pain Rating Scale, the FLACC scale, and heart rate, the sensation of pain during dental injection in both girls and boys is statistically significantly lower at body temperature than at room temperature (p < 0.05). CONCLUSIONS It was determined that the application of local anesthetic at body temperature reduces dental injection pain significantly when compared with local anesthetics administered at room temperature. CLINICAL RELEVANCE The successful management of dental injection pain is an important issue during dental procedures in children. Accordingly, warming the local anesthesia prior to use in children can be recommended to clinicians.",2020,"It was determined that the application of local anesthetic at body temperature reduces dental injection pain significantly when compared with local anesthetics administered at room temperature. ","['children', 'children undergoing dental procedures', '100 children aged 5-8 years']","['warm local anesthetics', 'body or room temperature local anesthesia', 'warm local anesthetic (37 °C) administration and injections of local anesthetics at room temperature (21 °C']","['Face, Legs, Arms, Cry, and Consolability (FLACC) scale', 'dental injection pain', 'subjective measure of discomfort, and heart rate', 'pain', 'pain perception', 'score of the Wong-Baker Faces Pain Rating Scale, the FLACC scale, and heart rate, the sensation of pain', 'Wong-Baker Faces Pain Rating Scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",100.0,0.0334838,"It was determined that the application of local anesthetic at body temperature reduces dental injection pain significantly when compared with local anesthetics administered at room temperature. ","[{'ForeName': 'Hüsniye', 'Initials': 'H', 'LastName': 'Gümüş', 'Affiliation': 'Faculty of Dentistry, Department of Pediatric Dentistry, Erciyes University, Kayseri, Turkey. husniyegumus@yahoo.com.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Aydinbelge', 'Affiliation': 'Faculty of Dentistry, Department of Pediatric Dentistry, Erciyes University, Kayseri, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-019-03086-6'] 1277,31650315,"Effectiveness of a reciprocating single file, single cone endodontic treatment approach: a randomized controlled pragmatic clinical trial.","OBJECTIVES To compare the root filling quality, the sealer extrusion, and the healing rates of apical lesions addressed via two endodontic treatment approaches. The hypothesis tested was that both techniques present similar apical periodontitis healing results. MATERIALS AND METHODS This study was a parallel-design, pragmatic, and randomized clinical trial. One hundred twenty anterior teeth with necrotic pulps and apical periodontitis were randomly allocated to be either instrumented with hand files and obturated with the lateral compaction technique or instrumented with a single file in a reciprocating movement and obturated with a single-cone technique. The root canal filling quality, the occurrence of sealer extrusion, and apical periodontitis healing were the outcomes of interest. Data were analyzed through chi-square analysis, and the odds ratio for healing was adjusted using a logistic regression model (α = 0.05). RESULTS No significant differences were observed between the endodontic techniques regarding the root filling quality or sealer extrusion. Six months after treatment, both endodontic techniques presented equivalent results regarding apical periodontitis healing. The healing rate was affected only by the periapical status at baseline. CONCLUSIONS The obturation of the root canal of the anterior teeth using reciprocating file-matched single cones presented a similar quality to that obtained with manual instrumentation followed by the lateral condensation technique. Similar healing rates of apical lesions were also observed. CLINICAL RELEVANCE For treating anterior teeth with apical periodontitis, a reciprocating single-file, single-treatment protocol was as effective as a traditional protocol combining hand instrumentation and the lateral compaction obturation technique.",2020,No significant differences were observed between the endodontic techniques regarding the root filling quality or sealer extrusion.,"['For treating anterior teeth with apical periodontitis', 'One hundred twenty anterior teeth with necrotic pulps and apical periodontitis']",['instrumented with hand files and obturated with the lateral compaction technique or instrumented with a single file in a reciprocating movement and obturated with a single-cone technique'],"['healing rates of apical lesions', 'root canal filling quality, the occurrence of sealer extrusion, and apical periodontitis healing', 'root filling quality or sealer extrusion', 'apical periodontitis healing', 'healing rate', 'odds ratio for healing']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}]","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0035848', 'cui_str': 'Endodontic Obturation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0449942', 'cui_str': 'Sealer (attribute)'}, {'cui': 'C0443213', 'cui_str': 'Extrusion (qualifier value)'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",120.0,0.082917,No significant differences were observed between the endodontic techniques regarding the root filling quality or sealer extrusion.,"[{'ForeName': 'Fabricio Eneas Diniz', 'Initials': 'FED', 'LastName': 'de Figueiredo', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Bairro Sanatório, Aracaju, SE, CEP 49060-100, Brazil. fabricioeneas@hotmail.com.'}, {'ForeName': 'Laila F', 'Initials': 'LF', 'LastName': 'Lima', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}, {'ForeName': 'Ludmila S', 'Initials': 'LS', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Dentistry, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}, {'ForeName': 'Marcos B', 'Initials': 'MB', 'LastName': 'Correa', 'Affiliation': 'Department of Restorative Dentistry and Dental Materials, Federal University of Pelotas, 457, Gonçalves Chaves St. 5th floor, Pelotas, RS, 96015-560, Brazil.'}, {'ForeName': 'Manoel', 'Initials': 'M', 'LastName': 'Brito-Junior', 'Affiliation': 'Department of Dentistry, State University of Montes Claros, Av. Dr. Ruy Braga, s/n, Vila Mauriceia, Montes Claros, MG, 39401-089, Brazil.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Faria-E-Silva', 'Affiliation': 'Department of Dentistry, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-019-03077-7'] 1278,31356580,Therapeutic Hypothermia in Organ Donors: Follow-up and Safety Analysis.,"BACKGROUND In a recent trial, targeted mild hypothermia in brain-dead organ donors significantly reduced the incidence of delayed graft function after kidney transplantation. This trial was stopped early for efficacy. Here, we report long-term graft survival for all organs along with donor critical care end points. METHODS We assessed graft survival through 1 year of all solid organs transplanted from 370 donors who had been randomly assigned to hypothermia (34-35°C) or normothermia (36.5-37.5°C) before donation. Additionally, changes in standardized critical care end points were compared between donors in each group. RESULTS Mild hypothermia was associated with a nonsignificant improvement in 1-year kidney transplant survival (95% versus 92%; hazard ratio, 0.61 [0.31-1.20]; P = 0.15). Mild hypothermia was associated with higher 1-year graft survival in the subgroup of standard criteria donors (97% versus 93%; hazard ratio, 0.39 [0.15 to -1.00]; P = 0.05). There were no significant differences in graft survival of extrarenal organs. There were no differences in critical care end points between groups. CONCLUSIONS Mild hypothermia in the donor safely reduced the rate of delayed graft function in kidney transplant recipients without adversely affecting donor physiology or extrarenal graft survival. Kidneys from standard criteria donors who received targeted mild hypothermia had improved 1-year graft survival.",2019,"Mild hypothermia was associated with a nonsignificant improvement in one-year kidney transplant survival (95% vs. 92%, hazards ratio [HR]",['370 donors who had been randomly assigned to hypothermia (34-35°C) or normothermia (36.5-37.5°C) prior to donation'],[],"['Mild hypothermia', 'year graft survival', 'graft survival of extra-renal organs', 'hazards ratio [HR', 'year kidney transplant survival', 'rate of DGF', 'graft survival']","[{'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]",[],"[{'cui': 'C0445043', 'cui_str': 'Mild hypothermia (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.288728,"Mild hypothermia was associated with a nonsignificant improvement in one-year kidney transplant survival (95% vs. 92%, hazards ratio [HR]","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Malinoski', 'Affiliation': 'Section of Surgical Critical Care, VA Portland Healthcare System, Portland, OR.'}, {'ForeName': 'Madhukar S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Axelrod', 'Affiliation': 'University of Iowa Transplant Institute, Iowa City, IA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Berry Consultants, LLC, Austin, TX.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants, LLC, Austin, TX.'}, {'ForeName': 'Tahnee', 'Initials': 'T', 'LastName': 'Groat', 'Affiliation': 'Section of Surgical Critical Care, VA Portland Healthcare System, Portland, OR.'}, {'ForeName': 'Claus U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA.'}]",Transplantation,['10.1097/TP.0000000000002890'] 1279,30032464,Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial.,"PURPOSE Upper airway exercises for snoring treatment can be effective but difficult to administer and monitor. We hypothesized that a brief, relatively simple daily upper airway exercise regimen, administered by a smartphone application, would reduce snoring and encourage compliance. METHODS Targeted vowel sounds causing tongue base movements were incorporated into a voice-controlled smartphone game application. Participants with habitual snoring, apnea hypopnea index (AHI) ≤ 14 events/h, and BMI ≤ 32 kg/m 2 were randomly assigned to perform 15 min of daily gameplay (intervention group) or 5 s of daily voice recording (control group) and to audio record their snoring for 2 nights/week for up to 12 weeks. Sounds above 60 dB were extracted from recordings for snore classification with machine learning support vector machine classifiers. RESULTS Sixteen patients (eight in each group) completed the protocol. Groups were similar at baseline in gender distribution (five males, three females), mean BMI (27.5 ± 3.8 vs 27.4 ± 3.8 kg/m 2 ), neck circumference (15.1 ± 1.6 vs 14.7 ± 1.7 in.), Epworth Sleepiness Score (8 ± 3.5 vs 7 ± 4.0), and AHI (9.2 ± 4.0 vs 8.2 ± 3.2 events/h). At 8 weeks, the absolute change in snoring rate (> 60 dB/h) was greater for the intervention group than the control group (- 49.3 ± 55.3 vs - 6.23 ± 23.2; p = 0.037), a 22 and 5.6% reduction, respectively. All bed partners of participants in the intervention group reported reduced snoring volume and frequency, whereas no change was reported for the control group. CONCLUSIONS Smartphone application-administered upper airway training reduces objective and subjective snoring measures and improves sleep quality. TRIAL REGISTRATION ClinicalTrials.gov ; no.: NCT03264963; URL: www.clinicaltrials.gov.",2019,"At 8 weeks, the absolute change in snoring rate (> 60 dB/h) was greater for the intervention group than the control group (- 49.3 ± 55.3 vs - 6.23 ± 23.2; p = 0.037), a 22 and 5.6% reduction, respectively.","['Participants with habitual snoring, apnea hypopnea index (AHI)\u2009≤\u200914\xa0events/h, and BMI\u2009≤\u200932\xa0kg/m 2', 'snoring', 'Groups were similar at baseline in gender distribution (five males, three females), mean BMI (27.5\u2009±\u20093.8 vs 27.4\u2009±\u20093.8\xa0kg/m 2 ), neck circumference (15.1\u2009±\u20091.6 vs 14.7\u2009±']","['perform 15\xa0min of daily gameplay (intervention group) or 5\xa0s of daily voice recording (control group) and to audio record their snoring', 'Smartphone-based delivery of oropharyngeal exercises', 'Smartphone application-administered upper airway training']","[' Epworth Sleepiness Score', 'reduced snoring volume and frequency', 'sleep quality', 'objective and subjective snoring measures', 'absolute change in snoring rate']","[{'cui': 'C4510110', 'cui_str': 'Habitual snoring (finding)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0439565,"At 8 weeks, the absolute change in snoring rate (> 60 dB/h) was greater for the intervention group than the control group (- 49.3 ± 55.3 vs - 6.23 ± 23.2; p = 0.037), a 22 and 5.6% reduction, respectively.","[{'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Goswami', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, 420 Delaware St. S.E, MMC 276, Minneapolis, MN, 55455, USA. goswa009@umn.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Black', 'Affiliation': 'Medical Devices Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Krohn', 'Affiliation': 'Medical Devices Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Meyers', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, 420 Delaware St. S.E, MMC 276, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Iber', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, 420 Delaware St. S.E, MMC 276, Minneapolis, MN, 55455, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1690-y'] 1280,30025941,Computerized Residency Interview Scheduling: A Randomized Controlled Trial of Categorical General Surgery Applicants.,"OBJECTIVE Scheduling interviews can be stressful and time-intensive for general surgery applicants and program coordinators. The objectives of this study were to determine whether computerized scheduling program (CSP) would decrease time to schedule interviews, reduce workload for residency coordinators, and improve applicant satisfaction. DESIGN A prospective randomized controlled trial of 2 interview-scheduling methods was conducted. All categorical general surgery applicants selected to interview for the 2017 match were randomized to either standard e-mail/phone scheduling or CSP using InterviewBroker. Time required to schedule an interview, number of communications, reschedules, withdrawals, and cancellations were all recorded. Additionally, applicants completed a voluntary, anonymous 9-question paper survey on their interview date. The program director and interviewers were blinded to the experimental groups. SETTING A single general surgery residency program. PARTICIPANTS Participants in the study included all categorical general surgery applicants selected for an interview in the 2017 match cycle (N = 62 standard group, N = 62 CSP group). RESULTS The CSP group took less time to schedule interviews (9 minutes vs. 80 minutes; p < 0.01), had fewer e-mail/phone communications (3 vs. 1; p < 0.01), and more total rescheduling events (26 vs. 4; p = 0.03) when compared to the standard group. Survey responses showed that 55% of applicants used CSPs at 5 or fewer other programs. The CSP group reported increased overall satisfaction (80% vs. 56% very satisfied; p = 0.02) and access to preferred interview dates (80% vs. 53% very satisfied; p = 0.02). Overall, 77% of applicants responded that CSPs should be widely adopted among general surgery residency programs. CONCLUSIONS CSPs expedited interview scheduling, decreased workload for program coordinators, and improved general surgery applicant satisfaction. However, despite the benefits of CSPs for programs and applicants, CSP use is not widespread among general surgery residency programs. Adoption of CSPs by all programs could greatly improve interview-scheduling processes for applicants and programs.",2019,"The CSP group took less time to schedule interviews (9 minutes vs. 80 minutes; p < 0.01), had fewer e-mail/phone communications (3 vs. 1; p < 0.01), and more total rescheduling events (26 vs. 4; p = 0.03) when compared to the standard group.","['All categorical general surgery applicants selected to interview for the 2017 match', 'Participants in the study included all categorical general surgery applicants selected for an interview in the 2017 match cycle (N\u202f=\u202f62 standard group, N\u202f=\u202f62 CSP group', 'A single general surgery residency program']","['standard e-mail/phone scheduling or CSP using InterviewBroker', 'computerized scheduling program (CSP', 'CSP', 'CSPs', 'Computerized Residency Interview Scheduling']","['access to preferred interview dates', 'Time required to schedule an interview, number of communications, reschedules, withdrawals, and cancellations', 'overall satisfaction', 'total rescheduling events']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205541', 'cui_str': 'Rescheduled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0612386,"The CSP group took less time to schedule interviews (9 minutes vs. 80 minutes; p < 0.01), had fewer e-mail/phone communications (3 vs. 1; p < 0.01), and more total rescheduling events (26 vs. 4; p = 0.03) when compared to the standard group.","[{'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Hoops', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, Portland, Oregon. Electronic address: hoops@ohsu.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Brasel', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Caroline Q', 'Initials': 'CQ', 'LastName': 'Stephens', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Anderson', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Krishnaswami', 'Affiliation': 'Department of Surgery, Oregon Health and Science University, Portland, Oregon.'}]",Journal of surgical education,['10.1016/j.jsurg.2018.06.001'] 1281,31667685,Effects of Selenium Supplementation on Asymmetric Dimethylarginine and Cardiometabolic Risk Factors in Patients with Polycystic Ovary Syndrome.,"Polycystic ovary syndrome (PCOS) is characterized by various reproductive and cardiometabolic disorders. Asymmetric dimethylarginine (ADMA) is associated with cardiovascular, metabolic, and hormonal status. Selenium, a micronutrient with antioxidant properties, could affect multiple physiological pathways. This study aimed to investigate the effect of selenium supplementation on ADMA, cardiometabolic risk factors, and hormonal status in women with PCOS. In this randomized, double-blind, placebo-controlled clinical trial, 66 women with PCOS, aged 18-45 years, were randomly assigned to receive either 200 μg/day selenium or placebo, for 12 weeks. Circulating concentrations of ADMA, testosterone, sex hormone-binding globulin (SHBG), lipid profiles, and glycemic parameters were assessed at baseline and following supplementation. ADMA concentration decreased significantly compared to baseline values (85.14 ± 75 to 56.4 ± 38.64 ng/l, p = 0.02) in the selenium group. This change was marginally significant compared with the placebo group (28.74 ± 68.63 vs. - 1.77 ± 52.88 ng/l, p = 0.056). Serum testosterone levels declined significantly in the intervention compared to the placebo group (0.01 ± 0.17 vs. - 0.08 ± 0.18 ng/ml, p = 0.038). Pre- to post-Apo-B100/Apo-A1 ratio declined considerably in the intervention group (0.72 ± 0.16 to 0.65 ± 0.16, p = 0.003). No further differences were observed in SHBG, lipid profiles, Apo-A1, Apo-B100, Apo-B100/Apo-A1 ratio, and glycemic control between the two groups at the end of the study. Selenium supplementation for 12 weeks had beneficial effects on reduction of circulating ADMA and total testosterone levels in women with PCOS. No significant improvements were seen in other cardiometabolic risk factors. The effects of selenium supplementation on hormonal, reproductive, and cardiometabolic disorders, considering the potential mediating role of ADMA, should be further investigated.",2020,ADMA concentration decreased significantly compared to baseline values (85.14 ± 75 to 56.4 ± 38.64 ,"['Polycystic ovary syndrome (PCOS', 'women with PCOS', '66 women with PCOS, aged 18-45\xa0years', 'Patients with Polycystic Ovary Syndrome']","['Selenium Supplementation', 'placebo', 'Asymmetric dimethylarginine (ADMA', 'selenium supplementation', 'Selenium supplementation', '200\xa0μg/day selenium or placebo']","['Apo-B100/Apo-A1 ratio', 'hormonal, reproductive, and cardiometabolic disorders', 'SHBG, lipid profiles, Apo-A1, Apo-B100, Apo-B100/Apo-A1 ratio, and glycemic control', 'cardiometabolic risk factors', 'Serum testosterone levels', 'Circulating concentrations of ADMA, testosterone, sex hormone-binding globulin (SHBG), lipid profiles, and glycemic parameters', 'ADMA, cardiometabolic risk factors, and hormonal status', 'ADMA concentration', 'Asymmetric Dimethylarginine and Cardiometabolic Risk Factors', 'circulating ADMA and total testosterone levels']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0853934', 'cui_str': 'Measurement of apolipoprotein A-I (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",66.0,0.280255,ADMA concentration decreased significantly compared to baseline values (85.14 ± 75 to 56.4 ± 38.64 ,"[{'ForeName': 'Batool Hossein', 'Initials': 'BH', 'LastName': 'Rashidi', 'Affiliation': 'Vali-E-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohammad Hosseinzadeh', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, No#44, Hojjatdoust St., Naderi St., Keshavarz Blvd, Tehran, 141556117, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Alipoor', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, No#44, Hojjatdoust St., Naderi St., Keshavarz Blvd, Tehran, 141556117, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, No#44, Hojjatdoust St., Naderi St., Keshavarz Blvd, Tehran, 141556117, Iran. hosseinzadeh.md.phd@gmail.com.'}]",Biological trace element research,['10.1007/s12011-019-01954-6'] 1282,31653801,Unilateral Elbow Flexion and Leg Press Training Induce Cross-Education But Not Global Training Gains in Children.,"PURPOSE Whereas cross-education has been extensively investigated with adults, there are far fewer youth investigations. Two studies suggested that children had greater global responses to unilateral knee extensor fatigue and training, respectively, than adults. The objective of this study was to compare global training responses and cross-education effects after unilateral elbow flexion (EFlex) and leg press (LP) training. METHODS Forty-three prepubertal youths (aged 10-13 y) were randomly allocated into dominant LP (n = 15), EFlex (n = 15) training groups, or a control (n = 13). Experimental groups trained 3 times per week for 8 weeks and were tested pretraining and posttraining for ipsilateral and contralateral 1-repetition maximum LP; knee extensor, knee flexors, elbow flexors; and handgrip maximum voluntary isometric contractions (MVIC), and countermovement jump. RESULTS In comparison to no significant changes with the control group, dominant elbow flexors training demonstrated significant ( P < .001) improvements only with ipsilateral and contralateral upper body testing (EFlex MVIC [15.9-21.5%], EFlex 1-repetition maximum [22.9-50.8%], handgrip MVIC [5.5-13.8%]). Dominant LP training similarly exhibited only significant ( P < .001) improvements for ipsilateral and contralateral lower body testing (LP 1-repetition maximum [59.6-81.8%], knee extensor MVIC [12.4-18.3%], knee flexor MVIC [7.9-22.3%], and countermovement jump [11.1-18.1%]). CONCLUSIONS The ipsilateral and contralateral training adaptations in youth were specific to upper or lower body training, respectively.",2020,"In comparison to no significant changes with the control group, dominant elbow flexors training demonstrated significant ( P < .001) improvements only with ipsilateral and contralateral upper body testing","['Forty-three prepubertal youths (aged 10-13\xa0y', 'Children']","['EFlex', 'tested pretraining and posttraining for ipsilateral and contralateral 1-repetition maximum LP; knee extensor, knee flexors, elbow flexors; and handgrip maximum voluntary isometric contractions (MVIC), and countermovement jump', 'Dominant LP training', 'Unilateral Elbow Flexion and Leg Press Training Induce Cross-Education', 'unilateral elbow flexion (EFlex) and leg press (LP) training', 'LP']","['global responses', 'ipsilateral and contralateral lower body testing (LP 1-repetition maximum', 'knee extensor MVIC', 'ipsilateral and contralateral upper body testing', 'knee flexor MVIC']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",,0.0154133,"In comparison to no significant changes with the control group, dominant elbow flexors training demonstrated significant ( P < .001) improvements only with ipsilateral and contralateral upper body testing","[{'ForeName': 'Aymen', 'Initials': 'A', 'LastName': 'Ben Othman', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Chaouachi', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Makhlouf', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Farthing', 'Affiliation': 'University of Saskatchewan.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'University of Potsdam.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': 'Memorial University of Newfoundland.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Chaouachi', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}]",Pediatric exercise science,['10.1123/pes.2019-0079'] 1283,30130424,Correlation Between Paramedic Disaster Triage Accuracy in Screen-Based Simulations and Immersive Simulations.,"Background: Disaster triage is an infrequent, high-stakes skill set used by emergency medical services (EMS) personnel. Screen-based simulation (SBS) provides easy access to asynchronous disaster triage education. However, it is unclear if the performance during a SBS correlates with immersive simulation performance. Methods: This was a nested cohort study within a randomized controlled trial (RCT). The RCT compared triage accuracy of paramedics and emergency medical technicians (EMTs) who completed an immersive simulation of a school shooting, interacted with an SBS for 13 weeks, and then completed the immersive simulation again. The participants were divided into two groups: those exposed vs. those not exposed to 60 Seconds to Survival © (60S) , a disaster triage SBS. The aim of the study was to measure the correlation between SBS triage accuracy and immersive simulation triage accuracy. Improvements in triage accuracy were compared among participants in the nested study before and after interacting with 60S , and with improvements in triage accuracy in a previous study in which immersive simulations were used as an educational intervention. Results: Thirty-nine participants completed the SBS; 26 (67%) completed at least three game plays and were included in the evaluation of outcomes of interest. The mean number of plays was 8.5 (SD =7.4). Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004). There was no correlation between the amount of improvement in overall SBS triage accuracy, instances of overtriage (P = 0.101), instances of undertriage (P = 0.523), and improvement in the second immersive simulation. A comparison of the pooled data from a previous immersive simulation study with the nested cohort data showed similar improvement in triage accuracy (P = 0.079). Conclusions: SBS education was associated with a significant increase in triage accuracy in an immersive simulation, although triage accuracy demonstrated in the SBS did not correlate with the performance in the immersive simulation. This improvement in accuracy was similar to the improvement seen when immersive simulation was used as the educational intervention in a previous study.",2019,"Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004).",['Thirty-nine participants completed the SBS; 26 (67%) completed at least three game plays'],['Screen-based simulation (SBS'],"['accuracy', 'triage accuracy', 'mean number of plays', 'overall SBS triage accuracy, instances of overtriage']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",39.0,0.0365779,"Subjects correctly triaged 12.4% more patients in the immersive simulation at study completion (73.1% before, 85.8% after, P = 0.004).","[{'ForeName': 'Mark X', 'Initials': 'MX', 'LastName': 'Cicero', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Whitfill', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Maria Carmen G', 'Initials': 'MCG', 'LastName': 'Diaz', 'Affiliation': ''}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Arteaga', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Scherzer', 'Affiliation': ''}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Goldberg', 'Affiliation': ''}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Madhok', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': ''}, {'ForeName': 'Geno', 'Initials': 'G', 'LastName': 'Paesano', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Redlener', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Munjal', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2018.1475530'] 1284,30012268,Exposure to improved nutrition from conception to age 2 years and adult cardiometabolic disease risk: a modelling study.,"BACKGROUND Low-income and middle-income countries with populations that are chronically undernourished in early life are undergoing a nutrition transition and are experiencing an epidemic of cardiometabolic disease. These dual burdens are thought to be causally related; therefore, the extent to which improvements in early-life nutrition can offset adult-onset disease is important. The aim of this study was to examine whether improvement of protein-energy nutrition from conception to age 2 years can attenuate the risk of cardiometabolic disease. METHODS We followed up a cohort of 2392 individuals born between Jan 1, 1962, and Feb 28, 1977, in four villages in Guatemala who had participated in a cluster-randomised protein-energy nutritional supplementation (Atole) trial. Of 1661 participants available for follow-up from Feb 26, 2015, to April 29, 2017, we studied 684 women and 455 men. We assessed cardiometabolic disease risk at ages 37-54 years using anthropometry, fasting and post-challenge glucose, fasting lipid concentrations, and blood pressure. We used generalised linear and logistic regression modelling to estimate the effect of Atole from conception to age 2 years (the first 1000 days) on cardiometabolic disease risk. FINDINGS Exposure to Atole from conception to age 2 years was associated with increased fatness (body-mass index [1·29 kg/m 2 , 95% CI 0·08 to 2·50], body fat [1·73%, 0·20 to 3·26], and obesity [odds ratio 1·94, 1·11 to 3·40]), diastolic blood pressure (1·59 mm Hg, -0·74 to 3·92), and blood lipids (total cholesterol [10·10 mg/dL, 0·80 to 19·40] and non-HDL cholesterol [10·41 mg/dL, 1·51 to 19·31]), reduced post-challenge glucose (-5·84 mg/dL, -12·51 to 0·83), and reduced odds of diabetes (odds ratio 0·46, 0·21 to 0·97). We found stratum heterogeneity by sex in pooled models for non-HDL cholesterol (4·34 mg/dL, 95% CI -6·86 to 15·55 for women vs 19·84 mg/dL, 5·86 to 33·82 for men) and post-challenge glucose (-0·19 mg/dL, -8·63 to 8·24 for women vs -13·10 mg/dL, -23·64 to -2·56 for men). p values for interaction of sex and exposure to Atole from conception to age 2 years were 0·09 and 0·04, respectively. INTERPRETATION Improved protein-energy nutrition from conception to the 2nd birthday reduced the odds of diabetes at ages 37-54 years; however, this protein-energy supplementation also increased the risk of obesity and several obesity-related conditions. Our findings suggest a mixed ability of protein-energy nutritional supplementation in early life to prevent adult cardiometabolic disease incidence in the context of high childhood stunting and high adult overweight and obesity. FUNDING National Institutes of Health.",2018,"reduced post-challenge glucose (-5·84 mg/dL, -12·51 to 0·83), and reduced odds of diabetes (odds ratio 0·46, 0·21 to 0·97).","['at ages 37-54 years using anthropometry, fasting and post-challenge glucose, fasting lipid concentrations, and blood pressure', '2392 individuals born between Jan 1, 1962, and Feb 28, 1977, in four villages in Guatemala who had participated in a cluster-randomised protein-energy nutritional supplementation (Atole) trial', '1661 participants available for follow-up from Feb 26, 2015, to April 29, 2017, we studied 684 women and 455 men']","['non-HDL cholesterol [10·41 mg/dL, 1·51 to 19·31', 'protein-energy nutritional supplementation']","['blood lipids (total cholesterol', 'diastolic blood pressure', 'cardiometabolic disease risk']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}]","[{'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",684.0,0.0303925,"reduced post-challenge glucose (-5·84 mg/dL, -12·51 to 0·83), and reduced odds of diabetes (odds ratio 0·46, 0·21 to 0·97).","[{'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'Ford', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jere R', 'Initials': 'JR', 'LastName': 'Behrman', 'Affiliation': 'Departments of Economics and Sociology, School of Arts and Sciences, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hoddinott', 'Affiliation': 'Division of Nutritional Sciences and Charles H Dyson School of Applied Economics and Management, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Maluccio', 'Affiliation': 'Department of Economics, Middlebury College, Middlebury, VT, USA.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'Institute of Nutrition of Central America and Panama Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, GA, USA. Electronic address: aryeh.stein@emory.edu.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30231-6'] 1285,30004818,Effects of in home high dose accelerometer-based feedback on perceived and actual use in participants chronic post-stroke.,"Purpose To explore the effects of home-based high dose accelerometer-based feedback on (1) perception of paretic upper extremity (UE) use; (2) actual amount of use (AOU); and (3) capability. The secondary purpose was to characterize paretic UE use in the home setting. Materials and Methods : Prospective experimental pre/post design (trial reg: NCT02995213). Eight participants chronic post-stroke (57.03 ± 6.64 y.o.) wore bilateral wrist accelerometers for 3 weeks during which seven sessions of accelerometer-based feedback were administered in the home. Accelerometer data (overall use, unimanual use, bimanual use, paretic/nonparetic use ratio, different intensities of use) were collected at all follow-up visits; clinical outcomes/questionnaires were collected at baseline, mid-study, and post-intervention. Results : After receiving high dose accelerometer-based feedback, participants had significant perceived gains in how much ( p  = 0.017) and how well ( p  = 0.050) they used the paretic UE. However, there were no significant group changes in actual paretic UE AOU or capability. Conclusions : In home high dose accelerometer-based feedback increased perceived paretic UE use and overall awareness of paretic UE use. Perception of use may serve as a first step to promote the behavioral change necessary to encourage actual paretic UE use, potentially decreasing the maladaptive effects of learned nonuse on participation.",2020,"After receiving high dose accelerometer-based feedback, participants had significant perceived gains in how much (p = 0.017) and how well (p = 0.050) they used the paretic UE.","['participants chronic post-stroke', 'Eight participants chronic post-stroke (57.03\xa0±\xa06.64 y.o']","['home-based high dose accelerometer-based feedback', 'home high dose accelerometer-based feedback', 'wore bilateral wrist accelerometers']","['paretic upper extremity (UE) use; (2) actual amount of use (AOU); and (3) capability', 'Accelerometer data (overall use, unimanual use, bimanual use, paretic/nonparetic use ratio, different intensities of use', 'actual paretic UE AOU or capability']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",8.0,0.0233413,"After receiving high dose accelerometer-based feedback, participants had significant perceived gains in how much (p = 0.017) and how well (p = 0.050) they used the paretic UE.","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Whitford', 'Affiliation': 'Doctor of Physical Therapy Program, Cleveland State University , Cleveland, OH, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Schearer', 'Affiliation': 'Department of Mechanical Engineering, Cleveland State University , Cleveland, OH, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rowlett', 'Affiliation': 'Psychology Department, Cleveland State University , Cleveland, OH, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1493759'] 1286,31644931,Trait and state approach-motivated positive affects interactively influence stress cardiovascular recovery.,"One of the potential mechanisms of positive affect (PA) in promoting physical health is by speeding up stress cardiovascular recovery. However, little is known whether high and low approach-motivated PA (AMPA) equally speed stress cardiovascular recovery and whether these effects are affected by personality traits that are associated with approach motivation. The present study investigated the impact of trait AMPA (assessed by sensation seeking) and state AMPA (elicited by positive stimuli) on stress cardiovascular recovery. After completion of Sensation Seeking Scale (SSS-V), 165 undergraduate students were subjected to a stress protocol, and then randomized to watch high AMPA, low AMPA and neutral pictures. Baseline, stress exposure, and post-stress cardiovascular data were collected. Results showed that compared to neutral and state low AMPA conditions, state high AMPA prolonged stress HR recovery. Moreover, individuals low in sensation seeking exhibited delayed SBP and DBP recovery under state high AMPA condition relative to state low AMPA and neutral conditions. Individuals high in sensation seeking exhibited comparable stress BP recovery across the three conditions. These findings suggest that the association between PA and stress cardiovascular recovery is contingent on approach motivational intensity, which might have health implications.",2019,Individuals high in sensation seeking exhibited comparable stress BP recovery across the three conditions.,['165 undergraduate students'],['trait AMPA (assessed by sensation seeking) and state AMPA (elicited by positive stimuli'],"['Baseline, stress exposure, and post-stress cardiovascular data', 'stress HR recovery', 'stress BP recovery', 'stress cardiovascular recovery']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0051318', 'cui_str': 'AMPA'}, {'cui': 'C0871336', 'cui_str': 'Sensation seeking'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449265', 'cui_str': 'Elicited by (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",,0.0314218,Individuals high in sensation seeking exhibited comparable stress BP recovery across the three conditions.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Shaanxi Key Laboratory of Behavior and Cognitive Neuroscience, Shaanxi Key Research Center for Children Mental and Behavioral Health, School of Psychology, Shaanxi Normal University, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lü', 'Affiliation': 'Shaanxi Key Laboratory of Behavior and Cognitive Neuroscience, Shaanxi Key Research Center for Children Mental and Behavioral Health, School of Psychology, Shaanxi Normal University, China. Electronic address: xuan006@126.com.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Hughes', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Lukasz D', 'Initials': 'LD', 'LastName': 'Kaczmarek', 'Affiliation': 'Institute of Psychology, Adam Mickiewicz University, Poland.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.08.011'] 1287,31634450,Impact of prefrontal intermittent theta-burst stimulation on working memory and executive function in Parkinson's disease: A double-blind sham-controlled pilot study.,"Cognitive impairment is a prevalent non-motor feature of Parkinson's disease (PD) which can present even in early stages of the disease. Impairments in executive processing and working memory (WM) are common and have been attributed, in part, to abnormalities within the dorsolateral prefrontal cortex (DLPFC) and broader fronto-striatal circuitry. Previous studies in cognitively normal adults have suggested intermittent Theta Burst Stimulation (iTBS), an excitatory plasticity-inducing non-invasive brain stimulation technique, can enhance these cognitive functions. Fourteen participants with a diagnosis of idiopathic PD received either Active or Sham iTBS over the left DLPFC across two separate experimental sessions as part of a double-blind sham-controlled crossover experimental design. The Berg's Card Sorting Test (BCST) and N-Back tasks, which measure executive function and WM respectively, were administered prior to iTBS and again five- and 30-minutes following stimulation. Despite being well-tolerated, iTBS failed to modulate performance on any of the cognitive outcome measures. This finding was further supported by Bayes Factor analyses which indicated moderate levels of support for the null hypothesis overall. This initial pilot study therefore does not support single-session iTBS as an efficacious method for modulating either executive processes or WM in PD. We discuss potential reasons for this finding along with directions for future research.",2020,This initial pilot study therefore does not support single-session iTBS as an efficacious method for modulating either executive processes or WM in PD.,"['Fourteen participants with a diagnosis of idiopathic PD', 'cognitively normal adults', ""Parkinson's Disease""]","['Prefrontal Intermittent Theta-Burst Stimulation', 'Active or Sham iTBS']","['Working Memory and Executive Function', 'executive processing and working memory (WM']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",14.0,0.171816,This initial pilot study therefore does not support single-session iTBS as an efficacious method for modulating either executive processes or WM in PD.,"[{'ForeName': 'Aron T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Neurology Department, The Alfred Hospital, Melbourne, Australia; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, ON, Canada. Electronic address: aron.hill@camh.ca.'}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'McModie', 'Affiliation': 'Neurology Department, The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Fung', 'Affiliation': 'Neurology Department, The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth HealthCare and Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Monash Alfred Psychiatry Research Centre, The Alfred and Monash University, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Sung-Wook', 'Initials': 'SW', 'LastName': 'Chung', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, The Alfred and Monash University, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Bertram', 'Affiliation': 'Neurology Department, The Alfred Hospital, Melbourne, Australia; Neurosciences, Central Clinical School, Monash University, Victoria, Australia.'}]",Brain research,['10.1016/j.brainres.2019.146506'] 1288,31863497,A Two-way Street: Mentor Stress and Depression Influence Relational Satisfaction and Attachment in Youth Mentoring Relationships.,"Over the past two decades, youth mentoring programs have increased in popularity as an intervention for children exposed to a range of stressful life circumstances. Such programs have been shown to promote positive youth development and reduce risk for emotional and behavioral problems; yet, the effect size of youth gains remains small. The current study examined the influence of college student mentors' history of early life stress and baseline depressive symptoms on their effectiveness in youth mentoring relationships using 340 randomized mentor-youth pairs from College Mentors for Kids, a well-established mentoring program with chapters across the United States. Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship. In contrast, mentors who experienced higher levels of early life stress had youth who reported greater satisfaction in the mentoring relationship and decreased relational anxiety. These findings are some of the first to examine the impact of mentor characteristics on mentor-youth relationships and highlight the importance of considering factors relevant to psychosocial functioning and emotional distress when recruiting, training, and supporting college student mentors.",2020,Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship.,"['youth mentoring relationships using 340 randomized mentor-youth pairs from College Mentors for Kids, a well-established mentoring program with chapters across the United States', 'Youth Mentoring Relationships']",[],['relational anxiety'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",340.0,0.05768,Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship.,"[{'ForeName': 'Emma G', 'Initials': 'EG', 'LastName': 'Preston', 'Affiliation': 'Department of Psychological Sciences, William & Mary, Williamsburg, VA, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Raposa', 'Affiliation': 'Department of Psychological Sciences, William & Mary, Williamsburg, VA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12412'] 1289,31863582,Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV.,"BACKGROUND People living with HIV in the USA smoke at a rate nearly three times that of the general population, and Black women are disproportionately affected by HIV infection. PURPOSE This study was conducted to test the preliminary efficacy of a digital storytelling intervention for smoking cessation in U.S. women living with HIV. METHODS Participants in the treatment arm viewed a film in which women living with HIV talk about quitting smoking, and those in the control arm viewed an attention-control film in which women talk about living with HIV infection. Participants in both arms received eight weekly video-call counseling sessions focused on smoking cessation and nicotine patches or gum during the same period. Participants were followed on a monthly basis from quit day for 3 months. RESULTS Of the 53 participants randomized, four withdrew before receiving any intervention, one dropped out during the intervention, and 48 (90.6%) completed the study. No difference was found in the baseline characteristics between the two arms with the exception that the treatment arm had higher nicotine dependence scores [t(1.51) = 2.30, p = .03] than the control arm. Seven day point-prevalence abstinence rates at 3 month follow-up were not found to differ between the two arms. However, the odds of achieving 3 month prolonged abstinence were four times greater (odds ratio = 4.23, 95% confidence interval = 1.10, 16.23) in the treatment arm than the control arm when the analysis was performed with those (n = 49, 92.5%) who received any part of the allotted intervention. CONCLUSIONS A digital storytelling intervention seems to be a valuable strategy to enhance the effect of conventional tobacco dependence treatment for women living with HIV. However, the underlying mechanism of the effect of digital storytelling necessitates further investigations in a large RCT.Clinical Trials Registration No. NCT03289676.",2020,No difference was found in the baseline characteristics between the two arms with the exception that the treatment arm had higher nicotine dependence scores [t(1.51) =,"['Participants in the treatment arm viewed a film in which women living with HIV talk about quitting smoking, and those in the', '53 participants randomized', 'U.S. women living with HIV', 'Women Living With HIV', 'women living with HIV']","['video-call counseling sessions focused on smoking cessation and nicotine patches or gum', 'control arm viewed an attention-control film', 'digital storytelling intervention', 'Digital Storytelling Intervention']","['odds of achieving 3 month prolonged abstinence', 'prevalence abstinence rates']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",53.0,0.102643,No difference was found in the baseline characteristics between the two arms with the exception that the treatment arm had higher nicotine dependence scores [t(1.51) =,"[{'ForeName': 'Sun S', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Sang A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Mejia', 'Affiliation': 'Department of Psychology, College of Liberal Arts and Sciences, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cooley', 'Affiliation': 'Phyllis F. Cantor Center, Research in Nursing and Patient Care Services, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Rosanna F', 'Initials': 'RF', 'LastName': 'Demarco', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz062'] 1290,30344582,Effect of bone graft granule volume on postoperative fusion after lumber spinal internal fixation: A retrospective analysis of 82 cases.,"Objective To investigate the effect of bone graft volume on postoperative fusion and symptom improvement in lumbar posterior lumbar fusion and internal fixation. Methods A total of 82 patients receiving pedicle screw rod system internal fixation with Cage bone graft fusion in the First Hospital of Baoding City, Hebei Province were selected and randomly divided into three groups. The excised autologous laminar bones were bitten into different sizes of bone fragments. And different sizes of bone grafts were implanted during the operation. Group-A (n=28) was implanted by bone graft granule with the average volume of 0.2 cm 3 , Group-B (n=27) was implanted by bone graft granule with the average volume of 0.1 cm 3 , and Group-C (n=27) was implanted by bone graft granule with the average volume of 0.05 cm 3 . The bone graft granule volume, clinical effect, bone graft fusion rate and intervertebral space height were compared. Results The three groups had significantly different bone graft granule volumes (P<0.05), but similar intervertebral bone graft total volumes and Cage heights (P>0.05). In the final follow-up, VAS and ODI of low back pain and two lower limbs pain significantly reduced compared with those before surgery (P<0.05), but the three groups had similar results (P>0.05). The bone graft fusions of Group-B one and two years after surgery were significantly higher than those of Group-A and Group-C, and the values of Group-A exceeded those of Group-C (P<0.05). In the final follow-up, the intervertebral space height change of Group-B was significantly smaller than those of Group-A and Group-C (P<0.05). Conclusion Size of bone graft granule has no significant effect on postoperative symptoms. However, middle-sized volume bone graft granule (0.1 cm 3 /granule) showed increased postoperative intervertebral fusion rate and reduced intervertebral space height loss in our study.",2018,"In the final follow-up, VAS and ODI of low back pain and two lower limbs pain significantly reduced compared with those before surgery (P<0.05), but the three groups had similar results (P>0.05).","['82 cases', '82 patients receiving pedicle screw rod system internal fixation with Cage bone graft fusion in the First Hospital of Baoding City, Hebei Province', 'after lumber spinal internal fixation']","['bone graft granule volume', 'bone graft volume']","['bone graft granule volume, clinical effect, bone graft fusion rate and intervertebral space height', 'postoperative symptoms', 'postoperative intervertebral fusion rate and reduced intervertebral space height loss', 'VAS and ODI of low back pain and two lower limbs pain', 'bone graft fusions', 'bone graft granule volumes', 'intervertebral bone graft total volumes and Cage heights', 'postoperative fusion']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0206427', 'cui_str': 'Retinal Rod'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0223088', 'cui_str': 'Structure of intervertebral space'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442106', 'cui_str': 'Intervertebral (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}]",82.0,0.017846,"In the final follow-up, VAS and ODI of low back pain and two lower limbs pain significantly reduced compared with those before surgery (P<0.05), but the three groups had similar results (P>0.05).","[{'ForeName': 'Jianxue', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Jianxue Hao, Baoding First Hospital, Baoding 071000, P. R. China.'}, {'ForeName': 'Chongchao', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Chongchao Yan, Baoding First Hospital, Baoding 071000, P. R. China.'}, {'ForeName': 'Suoli', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Suoli Liu, Baoding First Hospital, Baoding 071000, P. R. China.'}, {'ForeName': 'Pengfa', 'Initials': 'P', 'LastName': 'Tu', 'Affiliation': 'Pengfa Tu, Baoding First Hospital, Baoding 071000, P. R. China.'}]",Pakistan journal of medical sciences,['10.12669/pjms.345.14971'] 1291,30285151,Feasibility of a Smartphone-Based Tobacco Treatment for HIV-Infected Smokers.,"BACKGROUND Cigarette smoking is common among persons living with HIV (PLWH) in the United States. It is the leading cause of mortality in this group, and efforts to promote cessation have been largely unsuccessful. METHODS From 2015 to 2017, we performed a randomized controlled trial of Positively Smoke Free-Mobile (PSF-M) versus standard care. PSF-M is a mobile Web site that offers a 42-day text message-based quit-smoking program with smartphone features including quit-day selection/calendar, educational/motivational videos, and HELP button for cravings. RESULTS One hundred individuals enrolled, 48 were randomized to PSF-M (mean age = 45 years, 54% male, 81% black, 31% Latino) and 52 to the standard care condition. All participants were offered a 3-month supply of nicotine patches. Participants randomized to the mobile intervention visited the PSF-M home page a mean of 83 times, viewed 5.6/8 videos, logged in on 13 of 42 possible days, and received 131 texts. Among them, 77% tapped HELP for cravings, and craving response options were used by the following proportions: phone-a-friend, 58%; play-a-game, 29%; play-a-song, 4%. Older age and nonblack race were both associated with higher levels of engagement with the site. Of participants, 61% rated PSF-M very or extremely helpful, and 98% would recommend PSF-M to PLWH family or friends. Abstinence at 3 months, quit attempts, and daily cigarette intake all favored PSF-M over standard care but did not achieve statistical significance in our pilot sample. CONCLUSIONS Smartphone-based tobacco treatment for PLWH was feasible and achieved moderate-high rates of engagement and satisfaction in a middle-aged, ethnic or racial minority group in the poorest urban community in the United States. IMPLICATIONS Cigarette smoking has emerged as the leading killer of PLWH. Behavioral interventions have achieved only limited success in promoting cessation in this population. In this study, we explore the feasibility and preliminary efficacy of a multimodal, Web-based, quit-smoking intervention delivered to PLWH smokers via their smartphones.",2020,"In the current study we explore the feasibility and preliminary efficacy of a multimodal, web-based, quit-smoking intervention delivered to PLWH smokers via their smartphones.","['HIV-infected smokers', 'One hundred individuals enrolled, 48 were randomized to PSF-M (mean', 'persons living with HIV (PLWH', 'Older age and non-Black race', 'Methods\n\n\nFrom 2015-2017', '54% male, 81% Black, 31% Latino) and 52 to the standard care condition']","['Behavioral interventions', 'Positively Smoke Free- Mobile (PSF-M) vs. standard care', 'multimodal, web-based, quit-smoking intervention', 'smartphone-based tobacco treatment', 'nicotine patches']","['cravings, and craving response options']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}]",100.0,0.0550869,"In the current study we explore the feasibility and preliminary efficacy of a multimodal, web-based, quit-smoking intervention delivered to PLWH smokers via their smartphones.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuter', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Ryung S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'An', 'Affiliation': 'Department of Medicine, Center for Health Communications Research, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty208'] 1292,31509645,Impact of Background Music on Medical Student Anxiety and Performance During Anatomical Dissections: A Cluster Randomized Interventional Trial.,"Anatomical dissection on cadavers can be a source of anxiety for medical students. Studies in other stressful settings have shown a reduction in anxiety when there is background music. The objective of this study was to determine if music can have an impact on student anxiety, student satisfaction, and student performance in dissection room. This cluster randomized interventional trial included 187 second-year medical students. The intervention was standardized background music, selected based on the literature, with a tempo of between 60 and 80 bpm. Six balanced clusters were randomized (1:1) to music or no music during dissection sessions. The main assessment criterion was a validated self-evaluation scale score for anxiety, the State Trait Anxiety Inventory. Student satisfaction was measured using a visual analog scale and dissection performance was evaluated by an examination. The outcomes were analyzed with mixed models adjusted on group effect, chronic anxiety, and confounding factors. A significant (58%) relative decrease in acute anxiety, odds ratio 0.423 [0.160; 0.710] was found for the music intervention group. Music also had a positive impact on performance with students in the intervention group attaining higher grades than those in the control group (0.42/10 higher, P = 0.0016). The study also showed a nonsignificant increase in satisfaction with 0.37 extra points (P = 0.137) in the intervention group. Background music had a significant impact on anxiety in the dissection room and on technical and theoretical performance in the subsequent anatomy examination. This music intervention could be extended to other stressful work environments.",2020,"Music also had a positive impact on performance with students in the intervention group attaining higher grades than those in the control group (0.42/10 higher, P = 0.0016).",['187 second year medical students'],"['background music', 'music or no music during dissection sessions']","['visual analog scale and dissection performance', 'Student satisfaction', 'student anxiety, student satisfaction and student performance', 'chronic anxiety and confounding factors', 'anxiety', 'medical student anxiety and performance', 'acute anxiety', 'validated self-evaluation scale score for anxiety, the State Trait Anxiety Inventory', 'satisfaction']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0581386', 'cui_str': 'Chronic anxiety (finding)'}, {'cui': 'C0009673', 'cui_str': 'Confounding Variables'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",187.0,0.156582,"Music also had a positive impact on performance with students in the intervention group attaining higher grades than those in the control group (0.42/10 higher, P = 0.0016).","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bellier', 'Affiliation': 'French Alpes Laboratory of Anatomy, Department of Anatomy, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Secheresse', 'Affiliation': 'Faculty of Medicine, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Stoeckle', 'Affiliation': 'Faculty of Medicine, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dols', 'Affiliation': 'Department of Medical Evaluation, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Philippe C', 'Initials': 'PC', 'LastName': 'Chaffanjon', 'Affiliation': 'French Alpes Laboratory of Anatomy, Department of Anatomy, Grenoble Alpes University, Grenoble, France.'}]",Anatomical sciences education,['10.1002/ase.1918'] 1293,30235949,Is music-with-movement intervention better than music listening and social activities in alleviating agitation of people with moderate dementia? A randomized controlled trial.,"AIM Interactive music intervention is generally perceived as more effective on clinical outcomes than a receptive approach because it can better engage the people with dementia. The aim of this study is to compare the effects of the 6-week music-with-movement intervention on agitation of people with moderate dementia, music listening and social activity. METHODS A multi-centre randomized controlled trial was conducted on 165 nursing home residents with moderate dementia. The participants were randomly allocated into three groups: music-with-movement, music listening or social activities groups. Participants in the music-with-movement group listened to preferred music and moved their body parts for 45 minutes, twice a week for 6 weeks. While the participants in the music listening group only listened to their preferred music and social activity group chatted with the other group members. The agitation level was examined with the Chinese Cohen-Mansfield Agitation Inventory - Nursing Home version. Total scores and sub-scores (physically aggressive, physical non-aggressive, verbal aggressive and verbal non-aggressive) were compared at baseline, at post-intervention and 6 weeks post-intervention. RESULTS The results showed that there are no significant differences in agitation among three groups. Repeated measures univariate analyses revealed that all three groups yielded significant improvement in agitation from baseline to post-intervention, of which music-with-movement presented the largest effect size. CONCLUSION This study showed that interactive or receptive type of music intervention or social activities may be helpful in managing agitation although there is no statistically significant difference among them.",2020,"Total scores and sub-scores (physically aggressive, physical non-aggressive, verbal aggressive and verbal non-aggressive) were compared at baseline, at post-intervention and 6 weeks post-intervention.","['people with moderate dementia, music listening and social activity', '165 nursing home residents with moderate dementia']","['music-with-movement group listened to preferred music and moved their body parts', 'music listening group only listened to their preferred music and social activity', 'music-with-movement intervention', 'music-with-movement, music listening or social activities groups', 'music listening and social activities', 'Interactive music intervention']","['agitation level', 'Total scores and sub-scores (physically aggressive, physical non-aggressive, verbal aggressive and verbal non-aggressive', 'agitation']","[{'cui': 'C3494871', 'cui_str': 'Moderate dementia'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0229962', 'cui_str': 'Anatomic part'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]",165.0,0.16085,"Total scores and sub-scores (physically aggressive, physical non-aggressive, verbal aggressive and verbal non-aggressive) were compared at baseline, at post-intervention and 6 weeks post-intervention.","[{'ForeName': 'Daphne Sze Ki', 'Initials': 'DSK', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'Claudia Kam Yuk', 'Initials': 'CKY', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Mason Chin Pang', 'Initials': 'MCP', 'LastName': 'Leung', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}]","Dementia (London, England)",['10.1177/1471301218800195'] 1294,30217699,A daily multidisciplinary assessment of older adults undergoing elective colorectal cancer surgery is associated with reduced delirium and geriatric syndromes.,"OBJECTIVES Comprehensive geriatric assessment (CGA) has shown to benefit older patients undergoing urological and orthopedic surgery. However, this approach has been scarcely assessed in patients elected for colorectal surgery. MATERIALS AND METHODS Retrospective cohort of patients aged ≥70 years admitted for elective colorectal cancer surgery to a single hospital between 2008 and 2012. Upon admission, patients were assigned to a usual care (UC) plan or a CGA-based care (GS) plan conducted by a multidisciplinary team, according to standard clinical criteria.Analyzed outcomes included the incidence of delirium and other geriatric syndromes during hospital stay, mortality, readmissions, andnumber of perioperative complications. RESULTS The cohort included 310 patients, 203 assigned to the GS group and 107 to the UC group. Patients in the GS group had significantly lower Barthel and Lawton scores, higher prevalence of dementia and heart failure, and higher comorbidity burden. Fifty-four (17.5%) patientsexperienced delirium (23 [11.3%] and 31 [29.2%] in the GS and UC groups, respectively; p < .001), and 49 (15.8%) patient experienced other geriatric syndromes (21 [10.3%] and 28 [26.2%] in the GS and UC groups, respectively; p < .001). Serious complications were more frequent in the GS group: 154 (75.9%) vs 60 (56.1%) in the UC group; p < .001. No significant differences were observed between groups regarding readmissions, and in-hospital and post-discharge (1 year follow-up) mortality. CONCLUSIONS Despite the poorer clinical condition of patients in the GS group, the CGA-based intervention resulted in a lower incidence of delirium and other geriatric syndromes compared with the UC group.",2019,"No significant differences were observed between groups regarding readmissions, and in-hospital and post-discharge (1 year follow-up) mortality. ","['Retrospective cohort of patients aged ≥70\u202fyears admitted for elective colorectal cancer surgery to a single hospital between 2008 and 2012', '310 patients, 203 assigned to the GS group and 107 to the UC group', 'older patients undergoing urological and orthopedic surgery', 'older adults undergoing elective colorectal cancer surgery', 'patients elected for colorectal surgery']","['Comprehensive geriatric assessment (CGA', 'usual care (UC) plan or a CGA-based care (GS) plan conducted by a multidisciplinary team']","['Barthel and Lawton scores', 'prevalence of dementia and heart failure', 'Serious complications', 'delirium and other geriatric syndromes', 'incidence of delirium and other geriatric syndromes during hospital stay, mortality, readmissions, andnumber of perioperative complications', 'readmissions, and in-hospital and post-discharge (1\u202fyear follow-up) mortality', 'geriatric syndromes', 'patientsexperienced delirium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",310.0,0.0848307,"No significant differences were observed between groups regarding readmissions, and in-hospital and post-discharge (1 year follow-up) mortality. ","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tarazona-Santabalbina', 'Affiliation': 'Division of Geriatrics, Hospital Universitario de La Ribera (Alzira, Valencia, Spain), School of Nursing and Medicine, Universidad Católica de Valencia, San Vicente Martir, Spain. Electronic address: fjtarazona@hospital-ribera.com.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Llabata-Broseta', 'Affiliation': 'Division of Geriatrics, Hospital Universitario de La Ribera (Alzira, Valencia, Spain), School of Nursing and Medicine, Universidad Católica de Valencia, San Vicente Martir, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Belenguer-Varea', 'Affiliation': 'Division of Geriatrics, Hospital Universitario de La Ribera (Alzira, Valencia, Spain), School of Nursing and Medicine, Universidad Católica de Valencia, San Vicente Martir, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Álvarez-Martínez', 'Affiliation': 'Division of General and Digestive Surgery, Hospital Universitario de La Ribera (Alzira, Valencia, Spain), Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuesta-Peredo', 'Affiliation': 'Division of Records and Medical Documentation, UniversidadCatólica de Valencia, San Vicente Mártir, Spain.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Avellana-Zaragoza', 'Affiliation': 'Division of Geriatrics, Hospital Universitario de La Ribera (Alzira, Valencia, Spain), School of Nursing and Medicine, Universidad Católica de Valencia, San Vicente Martir, Spain.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2018.08.013'] 1295,30033738,Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State.,"OBJECTIVE The purpose of this study was to evaluate changes in the synovial fluid proteome following acute anterior cruciate ligament (ACL) injury. DESIGN This study represents a secondary analysis of synovial fluid samples collected from the placebo group of a previous randomized trial. Arthrocentesis was performed twice on 6 patients with an isolated acute ACL tear at a mean of 6 and 14 days postinjury. Synovial fluid was analyzed by a highly multiplexed assay of 1129 proteins (SOMAscan version 3, SomaLogic, Inc., Boulder, CO). Pathway analysis using DAVID was performed; genes included met 3 criteria: significant change between the 2 study time points using a paired t test, significant change between the 2 study time points using a Mann-Whitney nonparametric test, and significant Benjamini post hoc analysis. RESULTS Fifteen analytes demonstrated significant increases between time points. Five of the 15 have been previously associated with the onset and/or severity of rheumatoid arthritis, including apoliopoprotein E and isoform E3, vascular cell adhesion protein 1, interleukin-34, and cell surface glycoprotein CD200 receptor 1. Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury: MMP-1 ( P = 0.08, standardized response mean [SRM] = 1.00), MMP-3 ( P = 0.05, SRM = 0.90), ADAM12 ( P = 0.03, SRM = 1.31), aggrecan ( P = 0.08, SRM = 1.13), and CTX-II ( P = 0.07, SRM = 0.56). Notable pathways that were differentially expressed following injury were the cytokine-cytokine receptor interaction and osteoclast differentiation pathways. CONCLUSIONS The proteomic results and pathway analysis demonstrated a pattern of cartilage degeneration, not only consistent with previous findings but also changes consistent with an inflammatory arthritogenic process post-ACL injury.",2020,Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury:,"['injury', 'acute anterior cruciate ligament (ACL) injury', 'Anterior Cruciate Ligament Rupture']","['placebo', 'ADAM12']","['MMP-3', 'MMP-1', 'Chondrodegenerative enzymes and products of cartilage degeneration']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}]",6.0,0.0632535,Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury:,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'King', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Rowland', 'Affiliation': 'Central Texas Sports Medicine & Orthopedics, Bryan, TX, USA.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Villasante Tezanos', 'Affiliation': 'College of Health Sciences, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Kraus', 'Affiliation': 'Duke Molecular Physiology Institute, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': ""Department of Orthopaedic Surgery, Harvard Medical School and Brigham and Women's Hosptial, Chestnut Hill, MS, USA.""}, {'ForeName': 'Cale A', 'Initials': 'CA', 'LastName': 'Jacobs', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY, USA.'}]",Cartilage,['10.1177/1947603518790009'] 1296,29926431,"French Therapeutic Education Programme Aimed at Improving the Quality of Life of Laryngectomised Patients and their Close Relations: the Three Stages (Observational and Interventional Randomised) of the Study ""PETAL"".","The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology. Total laryngectomy is a mutilating surgical procedure having a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important and alter the quality of life of patients and their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on some technical procedures during hospital admission. The intervention of a speech therapist, often serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems. This report presents the therapeutic education programme protocol ""PETAL"" for laryngectomised patients and their close relations to improve their quality of life. The trial will be conducted over three phases: (1) the ""pilot"" phase aims at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations and developed a pluridisciplinary therapeutic education program, (2) the prospective intervention ""replication"" phase aims at evaluating the programme's transferability in three centres and (3) the cluster-randomised multicentric comparative intervention phase, will assess the benefits of the developed programme. Phase I identified nine themes of workshops related to therapeutic education, training and coordination of care. The developed programme should reinforce town-hospital links to improve help, follow-up and support for patients and their close relations.",2019,"The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology.",['of Laryngectomised Patients and their Close Relations'],['Total laryngectomy'],['Quality of Life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0189231', 'cui_str': 'Total laryngectomy (procedure)'}]",[{'cui': 'C0034380'}],,0.0187779,"The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology.","[{'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Heutte', 'Affiliation': 'UNIROUEN, CETAPS EA 3832, University of Normandy, Mont Saint-Aignan, France. natacha.heutte@univ-rouen.fr.'}, {'ForeName': 'Moumainn', 'Initials': 'M', 'LastName': 'Abouzayd', 'Affiliation': 'Head and Neck Department, University of Tours, Tours, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Plisson', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Trocmé', 'Affiliation': ""Lille University, UMR CNRS 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Rue du Barreau 59653, 60149, Villeneuve d'Ascq cedex, BP, France.""}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Seillier', 'Affiliation': ""CERFEP, CARSAT, Villeneuve d'Ascq cedex, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Christophe', 'Affiliation': ""Lille University, UMR CNRS 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Rue du Barreau 59653, 60149, Villeneuve d'Ascq cedex, BP, France.""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Guittet', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Grandazzi', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Babin', 'Affiliation': 'UMR 1086 INSERM « ANTICIPE » and University of Normandy, Caen, France.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1380-2'] 1297,29890086,Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial.,"RATIONALE New isolation of Pseudomonas aeruginosa (Pa) is generally treated with inhaled antipseudomonal antibiotics such as tobramycin inhalation solution (TIS). A therapeutic approach that complements traditional antimicrobial therapy by reducing the risk of pulmonary exacerbation and inflammation may ultimately prolong the time to Pa recurrence. OBJECTIVES To test the hypothesis that the addition of azithromycin to TIS in children with cystic fibrosis and early Pa decreases the risk of pulmonary exacerbation and prolongs the time to Pa recurrence. METHODS The OPTIMIZE (Optimizing Treatment for Early Pseudomonas aeruginosa Infection in Cystic Fibrosis) trial was a multicenter, double-blind, randomized, placebo-controlled, 18-month trial in children with CF, 6 months to 18 years of age, with early Pa. Azithromycin or placebo was given 3× weekly with standardized TIS. MEASUREMENTS AND MAIN RESULTS The primary endpoint was the time to pulmonary exacerbation requiring antibiotics and the secondary endpoint was the time to Pa recurrence, in addition to other clinical and safety outcomes. A total of 221 participants (111 placebo, 110 azithromycin) out of a planned 274 were enrolled. Enrollment was stopped early by the NHLBI because the trial had reached the prespecified interim boundary for efficacy. The risk of pulmonary exacerbation was reduced by 44% in the azithromycin group as compared with the placebo group (hazard ratio, 0.56; 95% confidence interval, 0.37-0.83; P = 0.004). Weight increased by 1.27 kg in the azithromycin group compared with the placebo group (95% confidence interval, 0.01-2.52; P = 0.046). No significant differences were seen in microbiological or other clinical or safety endpoints. CONCLUSIONS Azithromycin was associated with a significant reduction in the risk of pulmonary exacerbation and a sustained improvement in weight, but had no impact on microbiological outcomes in children with early Pa. Clinical trial registered with clinicaltrials.gov (NCT02054156).",2018,"Weight increased by 1.27 kg in the azithromycin group compared with the placebo group (95% confidence interval, 0.01-2.52; P = 0.046).","['Early Pseudomonas aeruginosa Infection in Cystic Fibrosis', 'children with CF, 6 months to 18 years of age, with early Pa', '221 participants (111 placebo, 110 azithromycin) out of a planned 274 were enrolled', 'was given 3× weekly with standardized TIS', 'children with cystic fibrosis', 'Cystic Fibrosis']","['placebo', 'Azithromycin', 'azithromycin', 'tobramycin inhalation solution (TIS', 'Azithromycin or placebo']","['microbiological outcomes', 'microbiological or other clinical or safety endpoints', 'risk of pulmonary exacerbation and prolongs the time to Pa recurrence', 'time to pulmonary exacerbation requiring antibiotics', 'Weight', 'risk of pulmonary exacerbation', 'time to Pa recurrence, in addition to other clinical and safety outcomes']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1154181', 'cui_str': 'Inhalation Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",274.0,0.656618,"Weight increased by 1.27 kg in the azithromycin group compared with the placebo group (95% confidence interval, 0.01-2.52; P = 0.046).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mayer-Hamblett', 'Affiliation': '1 Department of Pediatrics and.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Retsch-Bogart', 'Affiliation': '4 Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kloster', 'Affiliation': ""2 Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Accurso', 'Affiliation': '5 Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenfeld', 'Affiliation': '1 Department of Pediatrics and.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Albers', 'Affiliation': '7 Department of Pediatrics, Saint Louis University School of Medicine, Saint Louis, Missouri.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Black', 'Affiliation': ""8 Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': ""9 St. Luke's Regional Medical Center, Boise, Idaho.""}, {'ForeName': 'AnneMarie', 'Initials': 'A', 'LastName': 'Cairns', 'Affiliation': '10 Maine Medical Center, Portland, Maine.'}, {'ForeName': 'Stephanie D', 'Initials': 'SD', 'LastName': 'Davis', 'Affiliation': '11 Indiana University Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Gavin R', 'Initials': 'GR', 'LastName': 'Graff', 'Affiliation': '13 Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Gwendolyn S', 'Initials': 'GS', 'LastName': 'Kerby', 'Affiliation': '5 Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Orenstein', 'Affiliation': ""15 UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Buckingham', 'Affiliation': ""2 Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': '1 Department of Pediatrics and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201802-0215OC'] 1298,28637922,Targeting factor D of the alternative complement pathway reduces geographic atrophy progression secondary to age-related macular degeneration.,"Geographic atrophy is an advanced form of age-related macular degeneration (AMD) and a leading cause of vision loss for which there are no approved treatments. Genetic studies in AMD patients have implicated dysregulation of the alternative complement pathway in the pathogenesis of geographic atrophy. Lampalizumab is a potential therapeutic that targets complement factor D, a pivotal activator of the alternative complement pathway. The MAHALO phase 2 clinical trial was a multicenter, randomized, controlled study that evaluated lampalizumab administered by intravitreal injection monthly ( n = 42) and every other month ( n = 41) versus sham control ( n = 40) in patients with geographic atrophy secondary to AMD. The primary endpoint was the mean change in lesion area from baseline to month 18 as measured by fundus autofluorescence. Specific AMD-associated genetic polymorphisms were also analyzed. The MAHALO study met its primary efficacy endpoint with an acceptable safety profile; monthly lampalizumab treatment demonstrated a 20% reduction in lesion area progression versus sham control [80% confidence interval (CI), 4 to 37%]. A more substantial monthly treatment benefit of 44% reduction in geographic atrophy area progression versus sham control (95% CI, 15 to 73%) was observed in a subgroup of complement factor I ( CFI ) risk-allele carriers (57% of the patients analyzed were CFI risk-allele carriers). The MAHALO study shows a potential treatment effect in patients with geographic atrophy and supports therapeutic targeting of the alternative complement pathway for treating AMD pathogenesis.",2017,"Lampalizumab is a potential therapeutic that targets complement factor D, a pivotal activator of the alternative complement pathway.","['AMD patients', 'patients with geographic atrophy secondary to AMD', 'patients with geographic atrophy and supports therapeutic targeting of the alternative complement pathway for treating AMD pathogenesis']","['lampalizumab administered by intravitreal injection', 'Lampalizumab', 'sham control']","['lesion area progression', 'mean change in lesion area', 'geographic atrophy area progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009546', 'cui_str': 'Properdin Pathway'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0699748', 'cui_str': 'Pathogenesis (attribute)'}]","[{'cui': 'C4054668', 'cui_str': 'lampalizumab'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]",,0.038866,"Lampalizumab is a potential therapeutic that targets complement factor D, a pivotal activator of the alternative complement pathway.","[{'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Yaspan', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Williams', 'Affiliation': 'VitreoRetinal Surgery, PA, Minneapolis, MN 55404, USA.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Regillo', 'Affiliation': 'Wills Eye Hospital, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dressen', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'van Lookeren Campagne', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Kha N', 'Initials': 'KN', 'LastName': 'Le', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Graham', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Beres', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Tushar R', 'Initials': 'TR', 'LastName': 'Bhangale', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Honigberg', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Henry', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Ho', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA.'}, {'ForeName': 'Erich C', 'Initials': 'EC', 'LastName': 'Strauss', 'Affiliation': 'Genentech Inc., South San Francisco, CA 94080, USA. strauss.erich@gene.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Science translational medicine,['10.1126/scitranslmed.aaf1443'] 1299,31662328,Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial.,"OBJECTIVE To evaluate the neuroprotective effect of therapeutic hypothermia (TH) induced by phase changing material (PCM) on MRI biomarkers in infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting. DESIGN Open-label randomised controlled trial. SETTING One neonatal intensive care unit in a tertiary care centre in India. PATIENTS 50 term/near-term infants admitted within 5 hours after birth with predefined physiological criteria and signs of moderate/severe HIE. INTERVENTIONS Standard care (n=25) or standard care plus 72 hours of hypothermia (33.5°C±0.5°C, n=25) induced by PCM. MAIN OUTCOME MEASURES Primary outcome was fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat. RESULTS Primary outcome was available for 22 infants (44%, 11 in each group). Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts. After adjusting for sex, birth weight and gestational age, the mean difference in PLIC FA between groups was 0.026 (95% CI 0.004 to 0.048, p=0.023). Conventional MRI was available for 46 infants and demonstrated significantly less moderate/severe abnormalities in the cooled (n=2, 9%) than in the non-cooled (n=10, 43%) infants. There was no difference in adverse events between groups. CONCLUSIONS This study confirmed that TH induced by PCM reduced brain injury detected on MRI in infants with moderate HIE in a neonatal intensive care unit in India. Future research should focus on optimal supportive treatment during hypothermia rather than looking at efficacy of TH in low-resource settings. TRIAL REGISTRATION NUMBER CTRI/2013/05/003693.",2020,Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts.,"['50 term/near-term infants admitted within 5\u2009hours after birth with predefined physiological criteria and signs of moderate/severe HIE', 'infants with moderate HIE in a neonatal intensive care unit in India', 'neonatal hypoxic-ischaemic encephalopathy in India (THIN study', 'infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting', 'One neonatal intensive care unit in a tertiary care centre in India']","['PCM', 'Standard care (n=25) or standard care plus 72\u2009hours of hypothermia', 'Therapeutic hypothermia', 'TH', 'therapeutic hypothermia (TH) induced by phase changing material (PCM']","['adverse events', 'MRI biomarkers', 'PLIC FA', 'moderate/severe abnormalities', 'fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat']","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C1442467', 'cui_str': '5 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0152341', 'cui_str': 'Capsula Interna'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",,0.202317,Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts.,"[{'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Aker', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway karoline.aker@ntnu.no.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Støen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Live', 'Initials': 'L', 'LastName': 'Eikenes', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martinez-Biarge', 'Affiliation': 'Department of Paediatrics, Imperial College London, London, UK.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Nakken', 'Affiliation': 'Norwegian Advisory Unit for Functional MRI, Department of Radiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Asta Kristine', 'Initials': 'AK', 'LastName': 'Håberg', 'Affiliation': 'Norwegian Advisory Unit for Functional MRI, Department of Radiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Gibikote', 'Affiliation': 'Department of Radiology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Neonatology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-317311'] 1300,30301427,Blunted serum 25(OH)D response to vitamin D 3 supplementation in children with autism.,"Introduction: Data suggest a potential role for vitamin D in autism spectrum disorder (ASD) prevention and treatment. It is likely that the serum response to vitamin D supplementation contributes to its effectiveness. Multiple factors affect serum vitamin D 25(OH)D response to supplementation. Methods: We conducted post-hoc analysis of two double-blind, randomized, placebo-controlled trials (RCT) of vitamin D 3 supplementation, one RCT involving children with ASD and another involving children with asthma. Both trials were conducted in the same geographic location (Dublin, Ireland, 53°N), conducted over Winter season and utilized the same vitamin D 3 dose (2000 IU/day). Results: We included 18 children with ASD and 17 children with asthma. There was no significant difference in 25(OH)D or age at baseline, however, BMI was significantly lower in ASD ( P = 0.03). Compliance with vitamin D supplementation was high in both trials. Despite a significantly longer intervention period (20w vs. 15w; P  < 0.0001), ASD children had a significantly lower absolute increase (+26 vs. +45 nmol/l) in 25(OH)D ( P  = 0.04). Conclusions: Despite similar demographics, children with ASD had a lower increase in 25(OH)D levels with supplementation. Potential mechanisms include altered absorption/metabolism as well as well genetic factors. Clinical and research work relating to vitamin D is ASD should measure 25(OHO)D response to supplementation to assess therapeutic doses.",2020,"Despite a significantly longer intervention period (20w vs. 15w; P < 0.0001), ASD children had a significantly lower absolute increase (+26 vs. +45 nmol/l) in 25(OH)D (P = 0.04). ","['children with ASD and another involving children with asthma', '18 children with ASD and 17 children with asthma', 'children with autism']","['vitamin D', 'vitamin D 3 supplementation', 'vitamin D supplementation', 'placebo']","['BMI', 'serum vitamin D 25(OH)D response', '25(OH)D levels', 'Blunted serum 25(OH)D response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}]",18.0,0.262184,"Despite a significantly longer intervention period (20w vs. 15w; P < 0.0001), ASD children had a significantly lower absolute increase (+26 vs. +45 nmol/l) in 25(OH)D (P = 0.04). ","[{'ForeName': 'Conor P', 'Initials': 'CP', 'LastName': 'Kerley', 'Affiliation': ""Department of Paediatric Medicine, National Children's Hospital, Dublin 24, Ireland.""}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Elnazir', 'Affiliation': ""Paediatric Respiratory Department, National Children's Hospital, Dublin 24, Ireland.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Greally', 'Affiliation': ""Paediatric Respiratory Department, National Children's Hospital, Dublin 24, Ireland.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coghlan', 'Affiliation': ""Department of Paediatric Medicine, National Children's Hospital, Dublin 24, Ireland.""}]",Nutritional neuroscience,['10.1080/1028415X.2018.1529342'] 1301,31653669,Low-dose (0.01%) atropine eye-drops to reduce progression of myopia in children: a multicentre placebo-controlled randomised trial in the UK (CHAMP-UK)-study protocol.,"BACKGROUND/AIMS To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low-dose atropine (0.01%) eye-drops for reducing progression of myopia in UK children. METHODS Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6-12 years with myopia of -0.50 dioptres or worse in both eyes.We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for 2 years and attend a research centre every 6 months. The vehicle and preservative will be the same in both study arms.The primary outcome is SER of both eyes measured by autorefractor under cycloplegia at 2 years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events. CONCLUSIONS The Childhood Atropine for Myopia Progression in the UK study will be the first randomised trial reporting outcomes of low-dose atropine eye-drops for children with myopia in a UK population. TRIAL REGISTRATION NUMBER ISRCTN99883695, NCT03690089.",2020,"Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years.","['289 participants with an allocation ratio of 2:1 (193', 'children with myopia in a UK population', 'enrol children aged 6-12 years with myopia of -0.50 dioptres or worse in both eyes', 'children', 'UK children']","['atropine eye-drops', 'Childhood Atropine', 'atropine; 96 placebo', 'placebo', 'atropine']","['axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability', 'SER of both eyes measured by autorefractor under cycloplegia at 2\u2009years (adjusted for baseline', 'progression of myopia', 'peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness', 'refractive error and adverse events']","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0034380'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1275634', 'cui_str': 'Autorefractor'}, {'cui': 'C0235238', 'cui_str': 'Ciliary muscle paresis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0003151', 'cui_str': 'Anterior Chamber'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0022077', 'cui_str': 'Iris'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008779', 'cui_str': 'Corpus Ciliare'}, {'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}]",289.0,0.694121,"Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years.","[{'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Azuara-Blanco', 'Affiliation': ""Centre for Public Health, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK a.azuara-blanco@qub.ac.uk.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Logan', 'Affiliation': 'School of Life & Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Strang', 'Affiliation': 'Department of Vision Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Saunders', 'Affiliation': 'School of Biomedical Sciences, Ulster University, Coleraine, UK.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Allen', 'Affiliation': 'Department of Optometry and Ophthalmic Dispensing, Anglia Ruskin University, Cambridge, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Weir', 'Affiliation': 'NICTU, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Doherty', 'Affiliation': 'NICTU, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Adams', 'Affiliation': 'NICTU, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Evie', 'Initials': 'E', 'LastName': 'Gardner', 'Affiliation': 'NICTU, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Hogg', 'Affiliation': ""Centre for Public Health, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McFarland', 'Affiliation': 'Department of Pharmacy, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Preston', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Rejina', 'Initials': 'R', 'LastName': 'Verghis', 'Affiliation': 'NICTU, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Loughman', 'Affiliation': 'Optometry Department, Dublin Institute of Technology, Dublin, Ireland.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Flitcroft', 'Affiliation': 'Department of Ophthalmology, Childrens University Hospital, Dublin, Ireland.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mackey', 'Affiliation': 'Centre for Ophthalmology and Visual Science, University of Western Australia, Lions Eye Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Samantha Sze-Yee', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Centre for Ophthalmology and Visual Science, University of Western Australia, Lions Eye Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hammond', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, King's College London, London, UK.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Congdon', 'Affiliation': ""Centre for Public Health, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK.""}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-314819'] 1302,30243503,"Impact of colonic fermentation on sterols after the intake of a plant sterol-enriched beverage: A randomized, double-blind crossover trial.","BACKGROUND Cholesterol microbial transformation has been widely studied using in vitro fermentation assays, but less information is available on the biotransformation of plant sterols (PS). The excretion percentage of animal sterols (AS) (67-73%) is considerably greater than that of PS (27-33%) in feces from healthy humans following a Western diet. However, a lower content of AS in feces from subjects following a vegetarian, vegan or low-fat animal diet has been seen when compared to omnivorous subjects. Although only one human study has reported fecal sterol excretion after the consumption of PS-enriched food (8.6 g PS/day), it was found that the target group showed an increase in the excretion of cholesterol and a 57% decrease in its metabolites compared to the control group. OBJECTIVE Evaluation of the impact of a PS-enriched milk based fruit beverage intake on fecal sterol excretion and the microbial conversion of sterols in postmenopausal women with mild hypercholesterolemia. METHODS Forty postmenopausal women participated in a randomized, double-blind, crossover study with two beverages, with a PS-enriched (2 g PS/day) or without. The women were divided in two groups: 20 women consumed the PS-enriched beverage and the other 20 women consumed a placebo (without PS) beverage for 6 weeks. After a four-week washout period, the type of beverage was exchanged and consumed for another 6 weeks. Feces were collected at the start (0 and 10 weeks) and end of each intervention period (6 and 16 weeks), and fecal sterols were determined by capillary gas chromatography with mass spectrometry. RESULTS The intake of the PS-enriched beverage modified the fecal sterol excretion profile. A significant increase mainly in PS and their metabolites versus the placebo intervention period was observed. Although the same effect was not observed in the case of AS, a tendency towards increased cholesterol and decreased coprostanol (the main metabolite of cholesterol) was recorded after PS-enriched beverage intake versus placebo. Furthermore, the PS-enriched beverage also modified the microbial conversion of sterols. In this context, an important decrease in the conversion percentage of cholesterol in 16 women (between 11% and 50%) and of sitosterol in 24 women (between 15% and 61%) was observed. CONCLUSIONS The results obtained suggest that the microbiota could preferably use PS as a substrate, when present in a greater proportion compared with cholesterol. Besides, a lower sitosterol and cholesterol conversion trend would mean that intake of the PS-enriched beverage could modulate the metabolic activity of the gut microbiota. Therefore, further studies on the impact of PS-enriched foods upon gut microbiota modulation are needed. Clinical Trial Registry Number: NCT02065024 listed on the NIH website: ClinicalTrials.gov. Clinical Trial Registry Name: Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols (foodmagenpol). The full trial protocol is available upon request to the corresponding author.",2019,"Although the same effect was not observed in the case of AS, a tendency towards increased cholesterol and decreased coprostanol (the main metabolite of cholesterol) was recorded after PS-enriched beverage intake versus placebo.","['Forty postmenopausal women participated', 'sterols after the intake of a plant sterol-enriched beverage', 'postmenopausal women with mild hypercholesterolemia']","['placebo', 'Beta-cryptoxanthin and Phytosterols (foodmagenpol', 'colonic fermentation', 'PS-enriched milk based fruit beverage intake', 'PS-enriched beverage and the other 20 women consumed a placebo (without PS) beverage for 6 weeks']","['fecal sterol excretion profile', 'fecal sterol excretion', 'conversion percentage of cholesterol', 'excretion of cholesterol', 'excretion percentage of animal sterols (AS', 'PS and their metabolites']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038323', 'cui_str': 'Sterols'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0896117', 'cui_str': 'Beta-Cryptoxanthin'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0038323', 'cui_str': 'Sterols'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",40.0,0.214849,"Although the same effect was not observed in the case of AS, a tendency towards increased cholesterol and decreased coprostanol (the main metabolite of cholesterol) was recorded after PS-enriched beverage intake versus placebo.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Cuevas-Tena', 'Affiliation': 'Nutrition and Food Science Area, Faculty of Pharmacy, University of Valencia, Avda. Vicent Andrés Estellés s/n, 46100, Burjassot, Valencia, Spain. Electronic address: maria.cuevas-tena@uv.es.'}, {'ForeName': 'José D', 'Initials': 'JD', 'LastName': 'Bermúdez', 'Affiliation': 'Department of Statistics and Operations Research, University of Valencia, C/ Dr. Moliner 50, 46100, Burjassot, Valencia, Spain. Electronic address: Jose.D.Bermudez@uv.es.'}, {'ForeName': 'Ramona de Los Ángeles', 'Initials': 'RLÁ', 'LastName': 'Silvestre', 'Affiliation': 'Clinical Biochemistry, Hospital Universitario Puerta de Hierro-Majadahonda, Universidad Autónoma de Madrid, C/ Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. Electronic address: ramonaangeles.silvestre@salud.madrid.org.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Alegría', 'Affiliation': 'Nutrition and Food Science Area, Faculty of Pharmacy, University of Valencia, Avda. Vicent Andrés Estellés s/n, 46100, Burjassot, Valencia, Spain. Electronic address: amparo.alegria@uv.es.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Lagarda', 'Affiliation': 'Nutrition and Food Science Area, Faculty of Pharmacy, University of Valencia, Avda. Vicent Andrés Estellés s/n, 46100, Burjassot, Valencia, Spain. Electronic address: m.j.lagarda@uv.es.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.08.012'] 1303,29496516,Magnetic resonance imaging and spectroscopy evidence of efficacy for adrenal and gonadal hormone replacement therapy in anorexia nervosa.,"PURPOSE Dehydroepiandrosterone (DHEA)+estrogen/progestin therapy for adolescent girls with anorexia nervosa (AN) has the potential to arrest bone loss. The primary aim of this study was to test the effects of DHEA+estrogen/progestin therapy in adolescent girls with AN on bone marrow in the distal femur using magnetic resonance imaging (MRI) and spectroscopy. METHODS Seventy adolescent girls with AN were enrolled in a double blind, randomized, placebo-controlled trial at two urban hospital-based programs. INTERVENTION Seventy-six girls were randomly assigned to receive 12months of either oral micronized DHEA or placebo. DHEA was administered with conjugated equine estrogens (0.3mg daily) for 3months, then an oral contraceptive (20μg ethinyl estradiol/ 0.1mg levonorgestrel) for 9months. The primary outcome measure was bone marrow fat by MRI and magnetic resonance spectroscopy (MRS). RESULTS T2 of the water resonance dropped significantly less in the active vs. placebo group over 12months at both the medial and lateral distal femur (p=0.02). Body mass index (BMI) was a significant effect modifier for T1 and for T2 of unsaturated (T2 unsat ) and saturated fat (T2 sat ) in the lateral distal femur. Positive effects of the treatment of DHEA+estrogen/progestin were seen primarily for girls above a BMI of about 18kg/m 2 . CONCLUSIONS These findings suggest treatment with oral DHEA+estrogen/progestin arrests the age- and disease-related changes in marrow fat composition in the lateral distal femur reported previously in this population.",2018,"RESULTS T2 of the water resonance dropped significantly less in the active vs. placebo group over 12months at both the medial and lateral distal femur (p=0.02).","['adolescent girls with AN on bone marrow in the distal femur using magnetic resonance imaging (MRI) and spectroscopy', 'Seventy adolescent girls with AN', 'anorexia nervosa', 'adolescent girls with anorexia nervosa (AN', 'controlled trial at two urban hospital-based programs', 'Seventy-six girls']","['DHEA+estrogen/progestin therapy', 'placebo', 'Dehydroepiandrosterone (DHEA)+estrogen/progestin therapy', 'DHEA+estrogen/progestin', 'oral micronized DHEA or placebo', 'oral DHEA+estrogen/progestin', 'adrenal and gonadal hormone replacement therapy', 'conjugated equine estrogens', 'oral contraceptive (20μg ethinyl estradiol/ 0.1mg levonorgestrel', 'DHEA']","['bone marrow fat by MRI and magnetic resonance spectroscopy (MRS', 'Body mass index (BMI']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0301819', 'cui_str': 'Gonadal Hormones'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",76.0,0.639269,"RESULTS T2 of the water resonance dropped significantly less in the active vs. placebo group over 12months at both the medial and lateral distal femur (p=0.02).","[{'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Vajapeyam', 'Affiliation': ""Department of Radiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Ecklund', 'Affiliation': ""Department of Radiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'Mulkern', 'Affiliation': ""Department of Radiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': ""O'Donnell"", 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'DiVasta', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Clifford J', 'Initials': 'CJ', 'LastName': 'Rosen', 'Affiliation': 'Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Gordon', 'Affiliation': ""Division of Adolescent and Transition Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: catherine.gordon@cchmc.org.""}]",Bone,['10.1016/j.bone.2018.02.021'] 1304,30289026,"The pharmacodynamic profile of ""Blackadder"" blackcurrant juice effects upon the monoamine axis in humans: A randomised controlled trial.","Emerging evidence from human intervention trials indicates health benefits of consuming blackcurrant fruit, including improvements to cognitive performance, modulation of blood flow, regulation of blood glucose and inhibition of enzymes underpinning normal cognitive function. Of particular relevance is our previous demonstration of monoamine oxidase (MAO)-A and B inhibition after the consumption of a New Zealand ""Blackadder"" blackcurrant juice in humans. The current study uses a double-blind, placebo-controlled, randomised cross- over design to assess the pharmacodynamics of the effects on platelet MAO-B inhibition and associated substrates, plasma prolactin levels and blood glucose levels after consumption of a single serve of ""Blackadder"" blackcurrant juice standardised to 500 mg polyphenols. Eight healthy male (20--35 years) participants completed the trial. Measurements were obtained at baseline 15, 30, 45, 60, 100, 120, 150, 180, 240 mins and 24 h post dose. A fast, absolute and reversible inhibition of blood platelet MAO-B ( P  < 0.001) and a significant but delayed reduction in plasma prolactin ( P  < 0.001) were observed following the consumption of ""Blackadder"" blackcurrant juice when compared to a placebo control. No interpretable changes in substrates of MAO or associated metabolites were seen. These data provide a clear time course of the reversible inhibition of MAO-B after the single consumption of a of New Zealand ""Blackadder"" blackcurrant juice standardised at 500 mg of polyphenols and, therefore, provide a therapeutic window on which to base future nutritional interventions.",2020,"A fast, absolute and reversible inhibition of blood platelet MAO-B (P < 0.001) and a significant but delayed reduction in plasma prolactin (P < 0.001) were observed following the consumption of ""Blackadder"" blackcurrant juice when compared to a placebo control.","['Eight healthy male (20--35 years) participants completed the trial', 'humans']",['placebo'],"['plasma prolactin', 'platelet MAO-B inhibition and associated substrates, plasma prolactin levels and blood glucose levels', 'cognitive performance, modulation of blood flow, regulation of blood glucose and inhibition of enzymes underpinning normal cognitive function', 'blood platelet MAO-B', 'substrates of MAO or associated metabolites']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0857712', 'cui_str': 'Plasma prolactin'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0026456', 'cui_str': 'MAO-B'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1277971', 'cui_str': 'Plasma prolactin measurement'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0026454', 'cui_str': 'MAO'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",8.0,0.15244,"A fast, absolute and reversible inhibition of blood platelet MAO-B (P < 0.001) and a significant but delayed reduction in plasma prolactin (P < 0.001) were observed following the consumption of ""Blackadder"" blackcurrant juice when compared to a placebo control.","[{'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Watson', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne NE1 8ST, UK.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Scheepens', 'Affiliation': 'The New Zealand Institute for Plant & Food Research Ltd, Auckland 1025, New Zealand.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Kennedy', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne NE1 8ST, UK.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Cooney', 'Affiliation': 'The New Zealand Institute for Plant & Food Research Ltd, Auckland 1025, New Zealand.'}, {'ForeName': 'Tania M', 'Initials': 'TM', 'LastName': 'Trower', 'Affiliation': 'The New Zealand Institute for Plant & Food Research Ltd, Auckland 1025, New Zealand.'}, {'ForeName': 'Crystal F', 'Initials': 'CF', 'LastName': 'Haskell-Ramsay', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne NE1 8ST, UK.'}]",Nutritional neuroscience,['10.1080/1028415X.2018.1525950'] 1305,30271716,Effects of spinal manipulation and pain education on pain in patients with chronic low back pain: a protocol of randomized sham-controlled trial.,"Background Low back pain (LBP) has more than doubled in the last 20 years, probably influenced by biopsychosocial factors. Noninvasive treatments have been applied in individuals with chronic nonspecific LBP as spinal manipulation and pain education. However, the neurophysiological effects of these treatments are not clear. The aim of this research is to verify the pain control, functional and neurophysiological effects of spinal manipulation, and pain education in individuals with chronic nonspecific LBP. Methods This research is an assessor and subject blinded, 2-arm, randomized sham-controlled trial and will be conducted at Governador Celso Ramos Hospital, Florianópolis, Brazil. One hundred and twenty-eight individuals with chronic nonspecific LBP will be recruited for this study. Individuals will be randomly allocated into one of the two groups: (1) spinal manipulation plus pain education or (2) sham treatment plus pain education. Each group will be received two sessions per week over six weeks of treatment. The measures will be applied at baseline, six weeks, and three months after randomization. The primary outcome will be a pain intensity at six weeks postrandomization. Secondary outcomes will be pressure pain threshold, disability, fear and avoidance beliefs, kinesiophobia, risk of poor prognosis, quality of life, and inflammatory biomarkers. Discussion Evidence has shown that psychosocial factors are more involved in chronic pain than we thought a few years ago. Then, studies investigating both functional and neurophysiological effects of these interventions to evaluate the effectiveness of treatment and what else is happening at the cellular level in nervous system are needed.",2018,Individuals will be randomly allocated into one of the two groups: (1) spinal manipulation plus pain education or (2) sham treatment plus pain education.,"['patients with chronic low back pain', 'individuals with chronic nonspecific LBP', 'One hundred and twenty-eight individuals with chronic nonspecific LBP']","['spinal manipulation and pain education', 'spinal manipulation plus pain education or (2) sham treatment plus pain education']","['pressure pain threshold, disability, fear and avoidance beliefs, kinesiophobia, risk of poor prognosis, quality of life, and inflammatory biomarkers', 'pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",128.0,0.183872,Individuals will be randomly allocated into one of the two groups: (1) spinal manipulation plus pain education or (2) sham treatment plus pain education.,"[{'ForeName': 'Clécio', 'Initials': 'C', 'LastName': 'Vier', 'Affiliation': 'Graduate Program in Neurosciences, Center of Biological Sciences, Federal University of Santa Catarina, Trindade, Florianópolis, Brazil.'}, {'ForeName': 'Marcelo Anderson', 'Initials': 'MA', 'LastName': 'Bracht', 'Affiliation': 'Graduate Program in Neurosciences, Center of Biological Sciences, Federal University of Santa Catarina, Trindade, Florianópolis, Brazil.'}, {'ForeName': 'Marcos Lisboa', 'Initials': 'ML', 'LastName': 'Neves', 'Affiliation': 'Graduate Program in Neurosciences, Center of Biological Sciences, Federal University of Santa Catarina, Trindade, Florianópolis, Brazil.'}, {'ForeName': 'Maíra', 'Initials': 'M', 'LastName': 'Junkes-Cunha', 'Affiliation': 'Graduate Program in Neurosciences, Center of Biological Sciences, Federal University of Santa Catarina, Trindade, Florianópolis, Brazil.'}, {'ForeName': 'Adair Roberto Soares', 'Initials': 'ARS', 'LastName': 'Santos', 'Affiliation': 'Graduate Program in Neurosciences, Center of Biological Sciences, Federal University of Santa Catarina, Trindade, Florianópolis, Brazil.'}]",Integrative medicine research,['10.1016/j.imr.2018.04.003'] 1306,31680395,"A randomized, patient/evaluator-blinded, split-face study to compare the efficacy and safety of polycaprolactone and polynucleotide fillers in the correction of crow's feet: The latest biostimulatory dermal filler for crow's feet.","BACKGROUND No data on the clinical results and safety profiles of the polycaprolactone (PCL) -based dermal filler for crow's feet correction have been published. AIMS This study was designed to compare the efficacy and safety of a novel PCL-based dermal filler, DLMR01, with that of RJR, a purified polynucleotide dermal filler. PATIENTS/METHODS A total of 30 subjects with symmetric crow's feet of 2-4 points on the Crow's Feet Grading Scale (CFGS) were enrolled in this randomized, patient/evaluator-blinded, split-face study. Each subject was randomized to receive injections of DLMR01 or RJR in their right or left crow's feet. At 4 and 12 weeks, all participants were evaluated via CFGS, Global Aesthetic Improvement Scale (GAIS), and PRIMOS software system. RESULTS No significant difference in CFGS, GAIS, and R a value was detected between DLMR01 side and RJR at 12 weeks (improvement rate in CFGS from baseline at week 12-DLMR01: 48.28% [14/29], RJR: 41.38% [12/29]). CONCLUSION The novel PCL-based dermal filler DLMR01 shows suitable efficacy and safety, widening the selection possibilities for clinicians and patients in the treatment crow's feet.",2020,"No significant difference in CFGS, GAIS, and R a value was detected between DLMR01 side and RJR at 12 weeks (improvement rate in CFGS from baseline at week 12-DLMR01: 48.28% [14/29], RJR: 41.38% [12/29]). ","[""30 subjects with symmetric crow's feet of 2-4 points on the Crow's Feet Grading Scale (CFGS"", ""crow's feet""]","['DLMR01 or RJR', 'polycaprolactone (PCL) -based dermal filler', 'polycaprolactone and polynucleotide fillers', 'novel PCL-based dermal filler, DLMR01, with that of RJR']","['via CFGS, Global Aesthetic Improvement Scale (GAIS), and PRIMOS software system', 'efficacy and safety', 'CFGS, GAIS, and R a value']","[{'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0222045'}]","[{'cui': 'C0137734', 'cui_str': 'polycaprolactone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042850', 'cui_str': 'Skin Fillers'}, {'cui': 'C0032550', 'cui_str': 'Polynucleotides'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0511324,"No significant difference in CFGS, GAIS, and R a value was detected between DLMR01 side and RJR at 12 weeks (improvement rate in CFGS from baseline at week 12-DLMR01: 48.28% [14/29], RJR: 41.38% [12/29]). ","[{'ForeName': 'Guk Jin', 'Initials': 'GJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ga Ram', 'Initials': 'GR', 'LastName': 'Ahn', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13199'] 1307,29936918,Vitamin D supplementation and inflammatory and metabolic biomarkers in patients with knee osteoarthritis: post hoc analysis of a randomised controlled trial.,"The aim of this study was to determine whether vitamin D supplementation and maintaining vitamin D sufficiency are associated with changes in inflammatory and metabolic biomarkers in patients with knee osteoarthritis (OA) and vitamin D deficiency. A total of 413 participants with symptomatic knee OA and vitamin D deficiency were enrolled in a randomised, placebo-controlled trial and received 1·25 mg vitamin D3 or placebo monthly for 24 months across two sites. In this post hoc analysis, 200 participants from one site (ninety-four from the placebo group and 106 from the vitamin D group; mean age 63·1 (sd 7·3) years, 53·3 % women) were randomly selected for measurement of serum levels of inflammatory and metabolic biomarkers at baseline and 24 months using immunoassays. In addition, participants were classified into two groups according to serum 25-hydroxyvitamin D (25(OH)D) levels at months 3 and 24: (1) not consistently sufficient (25(OH)D≤50 nmol/l at either month 3 or 24, n 61), and (2) consistently sufficient (25(OH)D>50 nmol/l at both months 3 and 24, n 139). Compared with placebo, vitamin D supplementation had no significant effect on change in serum high-sensitive C-reactive protein, IL-6, IL-8, IL-10, leptin, adiponectin, resistin, adipsin and apelin. Being consistently vitamin D sufficient over 2 years was also not associated with changes in these biomarkers compared with not being consistently sufficient. Vitamin D supplementation and maintaining vitamin D sufficiency did not alter serum levels of inflammatory and metabolic biomarkers over 2 years in knee OA patients who were vitamin D insufficient, suggesting that they may not affect systemic inflammation in knee OA patients.",2018,"Compared with placebo, vitamin D supplementation had no significant effect on change in serum high-sensitive C-reactive protein, IL-6, IL-8, IL-10, leptin, adiponectin, resistin, adipsin and apelin.","['patients with knee osteoarthritis', 'patients with knee osteoarthritis (OA) and vitamin D deficiency', '413 participants with symptomatic knee OA and vitamin D deficiency', 'at months 3 and 24: (1) not consistently sufficient (25(OH)D≤50 nmol/l at either month 3 or 24, n 61), and (2) consistently sufficient (25(OH)D>50 nmol/l at both months 3 and 24, n 139', 'knee OA patients', '200 participants from one site (ninety-four from the placebo group and 106 from the vitamin D group; mean age 63·1 (sd 7·3) years, 53·3 % women']","['vitamin D supplementation', 'placebo', '1·25 mg vitamin D3 or placebo', 'Vitamin D supplementation', 'placebo, vitamin D supplementation']","['serum levels of inflammatory and metabolic biomarkers', 'serum 25-hydroxyvitamin D (25(OH)D) levels', 'serum high-sensitive C-reactive protein, IL-6, IL-8, IL-10, leptin, adiponectin, resistin, adipsin and apelin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0033457', 'cui_str': 'Properdin Factor D'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}]",413.0,0.311416,"Compared with placebo, vitamin D supplementation had no significant effect on change in serum high-sensitive C-reactive protein, IL-6, IL-8, IL-10, leptin, adiponectin, resistin, adipsin and apelin.","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': '2Department of Epidemiology and Preventive Medicine,Monash University,VIC,Australia.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Xingzhong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': '2Department of Epidemiology and Preventive Medicine,Monash University,VIC,Australia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Wluka', 'Affiliation': '2Department of Epidemiology and Preventive Medicine,Monash University,VIC,Australia.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Blizzard', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': '1Menzies Institute for Medical Research,University of Tasmania,Hobart,TAS,Australia.'}]",The British journal of nutrition,['10.1017/S0007114518001174'] 1308,31557064,Neoadjuvant Modified FOLFOX6 With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Final Results of the Chinese FOWARC Trial.,"PURPOSE In the multicenter, open-label, phase III FOWARC trial, modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy resulted in a higher pathologic complete response rate than fluorouracil plus radiotherapy in Chinese patients with locally advanced rectal cancer. Here, we report the final results. METHODS Adults ages 18 to 75 years with stage II/III rectal cancer were randomly assigned (1:1:1) to five cycles of infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2 over 48 hours) plus radiotherapy (46.0 to 50.4 Gy delivered in 23 to 25 fractions during cycles 2 to 4) followed by surgery and seven cycles of infusional fluorouracil, the same treatment plus intravenous oxaliplatin 85 mg/m 2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. The primary end point was 3-year disease-free survival (DFS). RESULTS In total, 495 patients were randomly assigned to treatment. After a median follow-up of 45.2 months, DFS events were reported in 46, 39, and 46 patients in the fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy, and mFOLFOX6 arms. In each arm, the probability of 3-year DFS was 72.9%, 77.2%, and 73.5% ( P = .709 by the log-rank test), the 3-year probability of local recurrence after R0/1 resection was 8.0%, 7.0%, and 8.3% ( P = .873 by the log-rank test), and the 3-year overall survival rate was 91.3%, 89.1%, and 90.7% ( P = .971 by log-rank test), respectively. CONCLUSION mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer. No significant difference in outcomes was found between mFOLFOX6 without radiotherapy and fluorouracil with radiotherapy, which requires additional investigation of the role of radiotherapy in these regimens.",2019,"CONCLUSION mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","['Locally Advanced Rectal Cancer', 'Adults ages 18 to 75 years with stage II/III rectal cancer', 'patients with locally advanced rectal cancer', '495 patients', 'Chinese patients with locally advanced rectal cancer']","['fluorouracil with radiotherapy', 'fluorouracil with radiation', 'fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy', 'infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2 over 48 hours) plus radiotherapy', 'infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy', 'fluorouracil plus radiotherapy', 'Without Radiation Versus Fluorouracil Plus Radiation', 'infusional fluorouracil', 'oxaliplatin 85 mg/m 2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6', 'Neoadjuvant Modified FOLFOX6']","['3-year overall survival rate', 'probability of 3-year DFS', '3-year probability of local recurrence', '3-year DFS', '3-year disease-free survival (DFS', 'DFS events']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",495.0,0.0663218,"CONCLUSION mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","[{'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lan', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Daoda', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Xiehe Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""The First People's Hospital, Guangzhou City, People's Republic of China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ""The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital, Foshan City, People's Republic of China.""}, {'ForeName': 'Zonghai', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Zhujiang Hospital, Nanfang University of Medical Science, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guanfu', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ""Guangdong Provincial Peoples Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhongcheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""General Hospital, Hunan Province, Changsha, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""The First Affiliated Hospital, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Xinhua Hospital, Dongguan, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhiyang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Meijin', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02309'] 1309,29801123,Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials.,"Importance Geographic atrophy (GA) secondary to age-related macular degeneration is a leading cause of visual disability in older individuals. A phase 2 trial suggested that lampalizumab, a selective complement factor D inhibitor, reduced the rate of GA enlargement, warranting phase 3 trials. Objective To assess the safety and efficacy of lampalizumab vs sham procedure on enlargement of GA. Design, Setting, and Participants Two identically designed phase 3 double-masked, randomized, sham-controlled clinical trials, Chroma and Spectri, enrolled participants from August 28, 2014, to October 6, 2016, at 275 sites in 23 countries. Participants were aged 50 years or older, with bilateral GA and no prior or active choroidal neovascularization in either eye and GA lesions in the study eye measuring 2.54 to 17.78 mm2 with diffuse or banded fundus autofluorescence patterns. Interventions Participants were randomized 2:1:2:1 to receive 10 mg of intravitreous lampalizumab every 4 weeks, sham procedure every 4 weeks, 10 mg of lampalizumab every 6 weeks, or sham procedure every 6 weeks, through 96 weeks. Main Outcomes and Measures Safety and efficacy assessed as mean change from baseline in GA lesion area at week 48 from centrally read fundus autofluorescence images of the lampalizumab arms vs pooled sham arms, in the intent-to-treat population and by complement factor I-profile genetic biomarker. Results A total of 906 participants (553 women and 353 men; mean [SD] age, 78.1 [8.1] years) were enrolled in Chroma and 975 participants (578 women and 397 men; mean [SD] age, 77.9 [8.1] years) were enrolled in Spectri; 1733 of the 1881 participants (92.1%) completed the studies through 48 weeks. The adjusted mean increases in GA lesion area from baseline at week 48 were 1.93 to 2.09 mm2 across all groups in both studies. Differences in adjusted mean change in GA lesion area (lampalizumab minus sham) were -0.02 mm2 (95% CI, -0.21 to 0.16 mm2; P = .80) for lampalizumab every 4 weeks in Chroma, 0.16 mm2 (95% CI, 0.00-0.31 mm2; P = .048) for lampalizumab every 4 weeks in Spectri, 0.05 mm2 (95% CI, -0.13 to 0.24 mm2; P = .59) for lampalizumab every 6 weeks in Chroma, and 0.09 mm2 (95% CI, -0.07 to 0.24 mm2; P = .27) for lampalizumab every 6 weeks in Spectri. No benefit of lampalizumab was observed across prespecified subgroups, including by complement factor I-profile biomarker. Endophthalmitis occurred after 5 of 12 447 injections (0.04%) or in 5 of 1252 treated participants (0.4%) through week 48. Conclusions and Relevance In Chroma and Spectri, the largest studies of GA conducted to date, lampalizumab did not reduce GA enlargement vs sham during 48 weeks of treatment. Results highlight the substantial and consistent enlargement of GA, at a mean of approximately 2 mm2 per year. Trial Registration ClinicalTrials.gov Identifier: NCT02247479 and NCT02247531.",2018,"Differences in adjusted mean change in GA lesion area (lampalizumab minus sham) were -0.02 mm2 (95% CI, -0.21 to 0.16 mm2; P = .80) for lampalizumab every 4 weeks in Chroma, 0.16 mm2 (95% CI, 0.00-0.31 mm2; P = .048) for lampalizumab every 4 weeks in Spectri, 0.05 mm2 (95% CI, -0.13 to 0.24 mm2; P = .59) for lampalizumab every 6 weeks in Chroma, and 0.09 mm2 (95% CI, -0.07 to 0.24 mm2; P = .27) for lampalizumab every 6 weeks in Spectri.","['Participants were aged 50 years or older, with bilateral GA and no prior or active choroidal neovascularization in either eye and GA lesions in the study eye measuring 2.54 to 17.78 mm2 with diffuse or banded fundus autofluorescence patterns', 'Participants\n\n\nTwo identically designed phase 3 double-masked, randomized, sham-controlled clinical trials, Chroma and Spectri, enrolled participants from August 28, 2014, to October 6, 2016, at 275 sites in 23 countries', '1733 of the 1881 participants (92.1%) completed the studies through 48 weeks', '906 participants (553 women and 353 men; mean [SD] age, 78.1 [8.1] years) were enrolled in Chroma and 975 participants (578 women and 397 men; mean [SD] age, 77.9 [8.1] years) were enrolled in Spectri', 'Age-Related Macular Degeneration', 'older individuals', 'Geographic Atrophy']","['Lampalizumab', 'intravitreous lampalizumab', 'lampalizumab']","['safety and efficacy', 'GA lesion area', 'Measures\n\n\nSafety and efficacy assessed as mean change from baseline in GA lesion area', 'rate of GA enlargement', 'Endophthalmitis', 'Efficacy and Safety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0423103', 'cui_str': 'Eye measure'}, {'cui': 'C0456786', 'cui_str': 'square millimeters'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C4517911', 'cui_str': '975 (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]","[{'cui': 'C4054668', 'cui_str': 'lampalizumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0014236', 'cui_str': 'Ophthalmia'}]",906.0,0.539779,"Differences in adjusted mean change in GA lesion area (lampalizumab minus sham) were -0.02 mm2 (95% CI, -0.21 to 0.16 mm2; P = .80) for lampalizumab every 4 weeks in Chroma, 0.16 mm2 (95% CI, 0.00-0.31 mm2; P = .048) for lampalizumab every 4 weeks in Spectri, 0.05 mm2 (95% CI, -0.13 to 0.24 mm2; P = .59) for lampalizumab every 6 weeks in Chroma, and 0.09 mm2 (95% CI, -0.07 to 0.24 mm2; P = .27) for lampalizumab every 6 weeks in Spectri.","[{'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Busbee', 'Affiliation': 'Tennessee Retina, Nashville.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Tufail', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Brittain', 'Affiliation': 'Genentech Inc, a Member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ferrara', 'Affiliation': 'Genentech Inc, a Member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Genentech Inc, a Member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Honigberg', 'Affiliation': 'Genentech Inc, a Member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Genentech Inc, a Member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Tong', 'Affiliation': 'Genentech Inc, a Member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Ehrlich', 'Affiliation': 'Genentech Inc, a Member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2018.1544'] 1310,31619065,Do Infant Cleft Dimensions Have an Influence on Occlusal Relations? A Subgroup Analysis Within an RCT of Primary Surgery in Patients With Unilateral Cleft Lip and Palate.,"AIM To investigate whether infant cleft dimensions, in a surgical protocol with early or delayed hard palate closure, influence occlusion before orthodontics. DESIGN Subgroup analysis within a randomized trial of primary surgery (Scandcleft). SETTING Tertiary health care. One surgical centre. PATIENTS AND METHODS A total of 122 unilateral cleft lip and palate infants received primary cheilo-rhinoplasty and soft palate closure at age 4 months and were randomized for hard palate closure at age 12 versus 36 months. A novel 3D analysis of cleft size and morphology was performed on digitized presurgical models. Occlusion was scored on 8-year models using the modified Huddarth-Bodenham (MHB) Index and the Goslon Yardstick. MAIN OUTCOME MEASUREMENTS Differences in MHB and Goslon scores among the 2 surgical groups adjusted for cleft size. RESULTS The crude analysis showed no difference between the 2 surgical groups in Goslon scores but a better MHB ( P = .006) for the group who received delayed hard palate closure. When adjusting for the ratio between cleft surface and palatal surface (3D Infant Cleft Severity Ratio) and for posterior cleft dimensions at tuberosity level, the delayed hard palate closure group received 3.65 points better for MHB (confidence interval: 1.81; 5.48; P < .001) and showed a trend for reduced risk of receiving a Goslon of 4 or 5 ( P = .052). For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group ( P = .033). CONCLUSIONS Seen from an orthodontic perspective, when the soft palate is closed first, and the cleft is large, the timing of hard palate closure should be planned in relation to posterior cleft size.",2020,"For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group ( P = .033). ","['122 unilateral cleft lip and palate infants received', 'Tertiary health care', 'Patients With Unilateral Cleft Lip and Palate']","['primary cheilo-rhinoplasty and soft palate closure at age 4 months and were randomized for hard palate closure', 'primary surgery (Scandcleft']","['Goslon scores', 'MHB and Goslon scores', 'Goslon score']","[{'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0030219', 'cui_str': 'Velum Palatinum'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",122.0,0.151436,"For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group ( P = .033). ","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Botticelli', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Küseler', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Marcusson', 'Affiliation': 'Maxillofacial Unit, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mølsted', 'Affiliation': 'Copenhagen Cleft Palate Center-University Hospital of Copenhagen-Denmark.'}, {'ForeName': 'Sven E', 'Initials': 'SE', 'LastName': 'Nørholt', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aarhus University Hospital-Denmark.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cattaneo', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Pedersen', 'Affiliation': 'Section of Orthodontics, Aarhus University, Aarhus, Denmark.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619875320'] 1311,29768152,Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome.,"BACKGROUND Cannabidiol has been used for treatment-resistant seizures in patients with severe early-onset epilepsy. We investigated the efficacy and safety of cannabidiol added to a regimen of conventional antiepileptic medication to treat drop seizures in patients with the Lennox-Gastaut syndrome, a severe developmental epileptic encephalopathy. METHODS In this double-blind, placebo-controlled trial conducted at 30 clinical centers, we randomly assigned patients with the Lennox-Gastaut syndrome (age range, 2 to 55 years) who had had two or more drop seizures per week during a 28-day baseline period to receive cannabidiol oral solution at a dose of either 20 mg per kilogram of body weight (20-mg cannabidiol group) or 10 mg per kilogram (10-mg cannabidiol group) or matching placebo, administered in two equally divided doses daily for 14 weeks. The primary outcome was the percentage change from baseline in the frequency of drop seizures (average per 28 days) during the treatment period. RESULTS A total of 225 patients were enrolled; 76 patients were assigned to the 20-mg cannabidiol group, 73 to the 10-mg cannabidiol group, and 76 to the placebo group. During the 28-day baseline period, the median number of drop seizures was 85 in all trial groups combined. The median percent reduction from baseline in drop-seizure frequency during the treatment period was 41.9% in the 20-mg cannabidiol group, 37.2% in the 10-mg cannabidiol group, and 17.2% in the placebo group (P=0.005 for the 20-mg cannabidiol group vs. placebo group, and P=0.002 for the 10-mg cannabidiol group vs. placebo group). The most common adverse events among the patients in the cannabidiol groups were somnolence, decreased appetite, and diarrhea; these events occurred more frequently in the higher-dose group. Six patients in the 20-mg cannabidiol group and 1 patient in the 10-mg cannabidiol group discontinued the trial medication because of adverse events and were withdrawn from the trial. Fourteen patients who received cannabidiol (9%) had elevated liver aminotransferase concentrations. CONCLUSIONS Among children and adults with the Lennox-Gastaut syndrome, the addition of cannabidiol at a dose of 10 mg or 20 mg per kilogram per day to a conventional antiepileptic regimen resulted in greater reductions in the frequency of drop seizures than placebo. Adverse events with cannabidiol included elevated liver aminotransferase concentrations. (Funded by GW Pharmaceuticals; GWPCARE3 ClinicalTrials.gov number, NCT02224560 .).",2018,"The most common adverse events among the patients in the cannabidiol groups were somnolence, decreased appetite, and diarrhea; these events occurred more frequently in the higher-dose group.","['Fourteen patients who received cannabidiol (9%) had elevated liver aminotransferase concentrations', 'patients with severe early-onset epilepsy', 'A total of 225 patients were enrolled; 76 patients', 'children and adults with the Lennox-Gastaut syndrome', '30 clinical centers, we randomly assigned patients with the Lennox-Gastaut syndrome (age range, 2 to 55 years) who had had two or more drop seizures per week during a 28-day baseline period to receive', 'patients with the Lennox-Gastaut syndrome, a severe developmental epileptic encephalopathy']","['conventional antiepileptic medication', 'cannabidiol oral solution at a dose of either 20 mg per kilogram of body weight (20-mg cannabidiol group) or 10 mg per kilogram (10-mg cannabidiol group) or matching placebo', 'placebo', 'Cannabidiol']","['somnolence, decreased appetite, and diarrhea', 'frequency of drop seizures', 'efficacy and safety', 'elevated liver aminotransferase concentrations', 'percentage change from baseline in the frequency of drop seizures', 'median number of drop seizures']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0270846', 'cui_str': 'Atonic Seizures'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0543888', 'cui_str': 'Epileptic encephalopathy (disorder)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0270846', 'cui_str': 'Atonic Seizures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",225.0,0.52034,"The most common adverse events among the patients in the cannabidiol groups were somnolence, decreased appetite, and diarrhea; these events occurred more frequently in the higher-dose group.","[{'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Devinsky', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Anup D', 'Initials': 'AD', 'LastName': 'Patel', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'J Helen', 'Initials': 'JH', 'LastName': 'Cross', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Villanueva', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Wirrell', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Privitera', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Greenwood', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Kevan E', 'Initials': 'KE', 'LastName': 'VanLandingham', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': 'Sameer M', 'Initials': 'SM', 'LastName': 'Zuberi', 'Affiliation': ""From New York University Langone Comprehensive Epilepsy Center, New York (O.D.); Nationwide Children's Hospital and the Ohio State University College of Medicine, Columbus (A.D.P.), and the University of Cincinnati Medical Center, Department of Neurology, Cincinnati (M.P.) - all in Ohio; UCL Great Ormond Street Institute of Child Health, London (J.H.C.), GW Research Ltd., Cambridge (S.M.G., C.R., D.C.), and the Royal Hospital for Children and School of Medicine, University of Glasgow, Glasgow (S.M.Z.) - all in the United Kingdom; Refractory Epilepsy Unit, Neurology Service, Hospital Universitario y Politécnico La Fe, Valencia, Spain (V.V.); the Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology, Mayo Clinic, Rochester, MN (E.C.W.); and Greenwich Biosciences, Carlsbad, CA (K.E.V.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1714631'] 1312,29730489,Does frontal knee kinematics predict treatment outcomes? Exploratory analyses from the Intensive Diet and Exercise for Arthritis (IDEA) trial.,"BACKGROUND Pain is a cardinal symptom of knee osteoarthritis (OA) and although conservative treatments such as exercise and diet related interventions can reduce pain, effects are modest and can be improved. Frontal plane knee joint motion has been associated with knee pain, and is suggested as a patient-specific characteristic on which to tailor interventions. RESEARCH QUESTION Does the association between baseline frontal plane knee joint kinematics and pain-relief differ among overweight and obese people with knee OA who underwent an intervention from the Intensive Diet and Exercise for Arthritis (IDEA) clinical trial: diet-only, exercise-only, and combined diet and exercise intervention? METHODS 323 participants with knee OA were included in the analysis (77% females; 66 ± 6 years; 33.5 ± 3.7 kg/m 2 ). At baseline, frontal plane knee joint kinematics during walking were measured using 3-dimensional gait analysis and characterised as peak varus-valgus knee angle, peak varus-valgus excursion, and peak varus angular velocity. Pain was assessed at baseline and 18-month follow-up using the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale. Linear regressions were performed unadjusted and adjusted for covariates to determine if the associations between baseline frontal plane knee joint kinematics and 18-month change in pain differed according to intervention. RESULTS The interaction terms between the intervention and measures of frontal plane knee joint kinematics were not statistically significant (all P ≥ 0.05). SIGNIFICANCE We found no evidence to suggest that 18-months of either exercise, diet, or a combination of diet and exercise could be more effective than the other to improve pain based on frontal plane measures of knee kinematics.",2018,"The interaction terms between the intervention and measures of frontal plane knee joint kinematics were not statistically significant (all P ≥ 0.05). ","['overweight and obese people with knee OA who underwent an intervention from the Intensive Diet and Exercise for Arthritis (IDEA) clinical trial', '323 participants with knee OA were included in the analysis (77% females; 66\u202f±\u202f6\u202fyears; 33.5\u202f±\u202f3.7\u202fkg/m 2 ']","['diet-only, exercise-only, and combined diet and exercise intervention']","['peak varus-valgus knee angle, peak varus-valgus excursion, and peak varus angular velocity', 'Pain', 'frontal plane knee joint kinematics', 'Western Ontario and McMaster Universities Osteoarthritis Index pain subscale']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551585', 'cui_str': 'Frontal plane'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}]",323.0,0.0405872,"The interaction terms between the intervention and measures of frontal plane knee joint kinematics were not statistically significant (all P ≥ 0.05). ","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, The University of Melbourne, VIC, Australia. Electronic address: halm@unimelb.edu.au.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, The University of Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Division of Public Health Sciences, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Tim V', 'Initials': 'TV', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, The University of Melbourne, VIC, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DeVita', 'Affiliation': 'Department of Kinesiology, College of Health and Human Performance, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, JB Snow Biomechanics Laboratory, Wake Forest University, Winston-Salem, NC, 27109, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2018.04.045'] 1313,31268132,A Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program Targeted to Women and Children in the First 1000 Days Increases Attainment of Language and Motor Milestones among Young Burundian Children.,"BACKGROUND Child development is affected by multiple factors throughout pregnancy and childhood. Multisectoral programs addressing these factors may improve children's development. OBJECTIVE We evaluated the impact of a food-assisted multisectoral nutrition program (Tubaramure) on children's (4-41.9 mo) motor and language development. Tubaramure was targeted to Burundian women and children in the first 1000 d and provided micronutrient-fortified food rations; nutrition, health, and hygiene behavior change communication; and health system-strengthening activities. METHODS Program impact was assessed using a cluster-randomized controlled trial with repeated cross-sections: 2010 (baseline, children 4-41.9 mo), 2012 (follow-up during implementation, children 4-23.9 mo), and 2014 (follow-up postimplementation, children 24-41.9 mo). Sixty villages were randomly assigned to 4 groups with varying timing and duration of food rations: pregnancy-24 mo; pregnancy-18 mo; 0-24 mo; and control, no direct Tubaramure benefits. Treatment groups were pooled and compared with control using difference-in-difference estimates. We examined impact pathways by assessing program impacts on intermediary variables and their associations with development outcomes. RESULTS At first follow-up, Tubaramure positively affected language (0.4 milestones, P < 0.05) but not motor development among children aged 4-23.9 mo. Among the 12-23.9 mo age subgroup, the program positively affected language (0.7 milestones, P < 0.01) and motor (0.6 milestones, P = 0.08) development. At second follow-up, among children aged 24-41.9 mo, Tubaramure marginally affected motor development (0.4 milestones, P = 0.09). In age subgroup analyses, program impacts were limited to children aged 24-29.9 mo [0.4 motor (P = 0.09) and 1.0 language (P < 0.01) milestones]. Pathway analyses revealed significant positive impacts on diet, health, and nutritional indicators of children aged 12-23.9 mo and health and nutritional indicators of children aged 24-29.9 mo, supporting the plausibility of program impacts on child development. CONCLUSIONS Tubaramure had small positive impacts on children's motor and language development through multiple pathways, demonstrating the role multisectoral nutrition programs can play in improving children's development. This trial was registered at clinicaltrials.gov as NCT01072279.",2019,"At second follow-up, among children aged 24-41.9 mo, Tubaramure marginally affected motor development (0.4 milestones, P = 0.09).","['Sixty villages', 'children 4-41.9 mo), 2012 (follow-up during implementation, children 4-23.9 mo), and 2014 (follow-up postimplementation, children 24-41.9 mo', 'Young Burundian Children', ""children's (4-41.9 mo) motor and language development""]","['Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program', 'food rations: pregnancy-24 mo; pregnancy-18 mo; 0-24 mo; and control, no direct Tubaramure benefits', 'food-assisted multisectoral nutrition program (Tubaramure']","['Attainment of Language and Motor Milestones', 'diet, health, and nutritional indicators', 'motor development']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0243107', 'cui_str': 'development'}]",60.0,0.0661882,"At second follow-up, among children aged 24-41.9 mo, Tubaramure marginally affected motor development (0.4 milestones, P = 0.09).","[{'ForeName': 'Deanna K', 'Initials': 'DK', 'LastName': 'Olney', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Jef L', 'Initials': 'JL', 'LastName': 'Leroy', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Bliznashka', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Ruel', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz133'] 1314,31271193,The Phenylalanine Requirement of Elderly Men and Women Measured by Direct 13C Carbon Oxidation Method Is Similar to That of Young Adults.,"BACKGROUND The phenylalanine requirement of the elderly is not known. Current recommendations are based on studies in young adults and are derived from a combined estimate of the total aromatic amino acids, phenylalanine, and tyrosine. OBJECTIVES The purpose of this study was to determine the dietary phenylalanine requirement of adults aged >65 y, using the direct amino acid oxidation method, by measuring the oxidation of l-[1-13C]phenylalanine to 13CO2 in response to graded phenylalanine intakes in the presence of excess tyrosine. METHODS Twelve subjects (6 men, 6 women), aged 73.8 ± 6.7 y (mean ± SD) and with a BMI (in kg/m2) of 26.4 ± 4.8 and 25.2 ± 4.4 for men and women, respectively, were randomized to phenylalanine intakes ranging from 7.20 to 40.0 mg .kg-1 .d-1 for a total of 66 studies. Study diets were isocaloric and isonitrogenous, providing protein and energy at 1.0 g .kg-1 .d-1 and 1.5 × resting energy expenditure (REE), respectively. Protein was provided as an amino acid mixture patterned after egg protein, with an excess of tyrosine and alanine to balance the nitrogen as phenylalanine intakes were varied. Two days prior to the study day, subjects were adapted to a milkshake diet providing protein at 1.0 g.kg-1 .d-1 and energy at 1.7 × REE. The mean phenylalanine requirement was determined using biphase linear regression analysis, which identified a breakpoint in the F13CO2 in response to graded phenylalanine intakes. RESULTS The mean and upper 95% CIs (approximating the recommended dietary allowance) of phenylalanine requirements were estimated to be 9.03 and 15.9 mg.kg-1 .d-1, respectively. CONCLUSION These results are similar to previously derived estimates of 9.1 and 13.6 mg.kg-1 .d-1 in young adult men and suggest that higher protein needs of the elderly to stimulate similar muscle protein synthesis rates as young adults are not driven by an increased requirement for phenylalanine. This trial was registered at clinicaltrials.gov as NCT02971059.",2019,"The mean phenylalanine requirement was determined using biphase linear regression analysis, which identified a breakpoint in the F13CO2 in response to graded phenylalanine intakes. ","['young adults', 'adults aged >65 y', 'Twelve subjects (6 men, 6 women), aged 73.8\xa0±\xa06.7 y (mean\xa0±\xa0SD) and with a BMI (in kg/m2) of 26.4\xa0±\xa04.8 and 25.2\xa0±\xa04.4 for men and women', 'Elderly Men and Women', 'young adult men']",['phenylalanine intakes ranging from 7.20 to 40.0 mg .kg-1'],['mean phenylalanine requirement'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}]","[{'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}]",,0.0667737,"The mean phenylalanine requirement was determined using biphase linear regression analysis, which identified a breakpoint in the F13CO2 in response to graded phenylalanine intakes. ","[{'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Mahroukh', 'Initials': 'M', 'LastName': 'Rafii', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sylwia', 'Initials': 'S', 'LastName': 'Szwiega', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz137'] 1315,31933020,A Behavioral Adherence Intervention Improves Rates of Viral Suppression Among Adherence-Challenged People Living with HIV in South India.,"The success of antiretroviral therapy (ART) has led to both extended life expectancy and improved quality of life among people living with HIV (PLWH). To maximize the efficacy of first line ART regimens in low- and middle-income countries (LMIC), we need culturally-relevant interventions that empower participants to reduce barriers to long-term uninterrupted adherence. The Chetana adherence intervention trial was designed in collaboration with local community groups as a comprehensive wellness program for adherence-challenged PLWH and included peer-led adherence support, yoga, nutrition, information about local resources, and individual counseling using motivational interviewing techniques. Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm. They were also about twice as likely as control arm participants to self-report ≥ 95% adherence (AOR = 1.86, 95% CI [1.09, 3.15]), and as having eliminated individual adherence barriers (AOR = 2.33, 95% CI [1.51, 3.62]) and clinic attendance barriers (AOR = 2.01, 95% CI [1.20, 3.38]) These low-cost strategies can be implemented by local NGOs, making it both scalable and sustainable in this and similar settings.",2020,"Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm.","['low- and middle-income countries (LMIC', 'Living with HIV in South India', 'people living with HIV (PLWH', 'Adherence-Challenged People']","['comprehensive wellness program for adherence-challenged PLWH and included peer-led adherence support, yoga, nutrition, information about local resources, and individual counseling using motivational interviewing techniques', 'Behavioral Adherence Intervention', 'antiretroviral therapy (ART']","['quality of life', 'Viral Suppression', 'clinic attendance barriers']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0034380'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0717147,"Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm.","[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA. Maria.Ekstrand@ucsf.edu.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': ""St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': ""D'Souza"", 'Affiliation': ""St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Shoba', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Ranjani', 'Initials': 'R', 'LastName': 'Shamsundar', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'B N Ravi', 'Initials': 'BNR', 'LastName': 'Kumar', 'Affiliation': 'Karnataka State AIDS Prevention Society, Bangalore, India.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Chandy', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}]",AIDS and behavior,['10.1007/s10461-020-02785-6'] 1316,31620073,Neurocognitive and Quality of Life Improvements Associated With Aerobic Training for Individuals With Persistent Symptoms After Mild Traumatic Brain Injury: Secondary Outcome Analysis of a Pilot Randomized Clinical Trial.,"Objective: To report secondary neurocognitive and quality of life outcomes for a pilot randomized clinical trial (RCT) of aerobic training for management of prolonged symptoms after a mild traumatic brain injury (mTBI) in adolescents. Setting: Outpatient research setting. Participants: Thirty adolescents between the ages of 12 and 17 years who sustained a mTBI and had between 4 and 16 weeks of persistent post-concussive symptoms. Design: Secondary outcome analysis of a partially masked RCT of sub-symptom exacerbation aerobic training compared with a full-body stretching program highlighting cognitive and quality of life outcomes. Main Measures: The secondary outcomes assessed included neurocognitive changes in fluid and crystallized age-adjusted cognition using the National Institutes of Health (NIH) toolbox and self and parent-reported total quality of life using the Pediatric Quality of Life Inventory. Results: Twenty-two percent of eligible participants enrolled in the trial. General linear models did not reveal statistically significant differences between groups. Within group analyses using paired t -tests demonstrated improvement in age-adjusted fluid cognition [ t (13) = 3.39, p = 0.005, Cohen's d = 0.61] and crystallized cognition [ t (13) = 2.63, p = 0.02, Cohen's d = 0.70] within the aerobic training group but no significant improvement within the stretching group. Paired t -tests demonstrated significant improvement in both self-reported and parent-reported total quality of life measures in the aerobic training group [self-report t (13) = 3.51, p = 0.004, Cohen's d = 0.94; parent-report t (13) = 6.5, p < 0.0001, Cohen's d = 1.80] and the stretching group [self-report t (14) = 4.20, p = 0.0009, Cohen's d = 1.08; parent-report t (14) = 4.06, p = 0.0012, Cohen's d = 1.045]. Conclusion: Quality of life improved significantly in both the aerobic exercise and stretching groups; however, this study suggests that only sub-symptom exacerbation aerobic training was potentially beneficial for neurocognitive recovery, particularly the fluid cognition subset in the NIH Toolbox. Limited sample size and variation in outcomes measures limited ability to detect between group differences. Future research should focus on developing larger studies to determine optimal timing post-injury and intensity of active rehabilitation to facilitate neurocognitive recovery and improve quality of life after mTBI. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02035579.",2019,"Paired t -tests demonstrated significant improvement in both self-reported and parent-reported total quality of life measures in the aerobic training group [self-report t (13) = 3.51, p = 0.004, Cohen's d = 0.94; parent-report t (13) = 6.5, ","['Results: Twenty-two percent of eligible participants enrolled in the trial', 'prolonged symptoms after a mild traumatic brain injury (mTBI) in adolescents', 'Individuals With Persistent Symptoms', 'After Mild Traumatic Brain Injury', 'Participants: Thirty adolescents between the ages of 12 and 17 years who sustained a mTBI and had between 4 and 16 weeks of persistent post-concussive symptoms']","['Aerobic Training', 'aerobic exercise and stretching groups', 'aerobic training']","['cognitive and quality of life outcomes', 'crystallized cognition', 'Quality of life', 'Neurocognitive and Quality of Life Improvements', 'total quality of life measures', 'neurocognitive changes in fluid and crystallized age-adjusted cognition using the National Institutes of Health (NIH) toolbox and self and parent-reported total quality of life using the Pediatric Quality of Life Inventory']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",30.0,0.182068,"Paired t -tests demonstrated significant improvement in both self-reported and parent-reported total quality of life measures in the aerobic training group [self-report t (13) = 3.51, p = 0.004, Cohen's d = 0.94; parent-report t (13) = 6.5, ","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Gladstone', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth and Case Western Reserve College of Medicine, Cleveland, OH, United States.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Narad', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, United States.""}, {'ForeName': 'Fadhil', 'Initials': 'F', 'LastName': 'Hussain', 'Affiliation': 'College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, United States.'}, {'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Quatman-Yates', 'Affiliation': ""Division of Occupational Therapy and Physical Therapy, Department of Physical Therapy, Cincinnati Children's Hospital Medical Center, The Ohio State University, Columbus, OH, United States.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hugentobler', 'Affiliation': ""Division of Occupational Therapy and Physical Therapy, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, United States.""}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Gubanich', 'Affiliation': ""Division of Sports Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University College of Medicine, Cincinnati, OH, United States.""}, {'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Departments of Pediatrics and Neurology and Rehabilitation Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, United States.""}]",Frontiers in neurology,['10.3389/fneur.2019.01002'] 1317,31576438,Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial.,"PURPOSE Data on the benefit or or harmful effects of oxygen level on ischemic reperfusion injuries in cardiac surgery are insufficient. We hypothesized that hyperoxia during cardiopulmonary bypass decreases the incidence of postoperative atrial fibrillation (POAF) and ventricular fibrillation, and therefore decreases cardiovascular morbidity (CARDIOX study). METHODS An open-label, randomized clinical trial including adults undergoing elective cardiac surgery, i.e. cardiopulmonary bypass (CPB) randomized 1:1 to an intervention group or standard group at two French University Hospitals from June 2016 to October 2018. The intervention consisted in delivering of an inspired fraction of oxygen of one to one during CPB. The standard care consisted in delivering oxygen to achieve a partial arterial blood pressure less than 150 mmHg. The primary endpoint was the occurrence of POAF and/or ventricular tachycardia/ventricular fibrillation (VT/VF) within the 15 days following cardiac surgery. The secondary endpoint was the occurrence of major adverse cardiovascular events (MACCE: in-hospital mortality, stroke, cardiac arrest, acute kidney injury, and mesenteric ischemia). RESULTS 330 patients were randomly assigned to either the intervention group (n = 161) or the standard group (n = 163). Mean PaO 2 was 447 ± 98 mmHg and 161 ± 60 mmHg during CPB, for the intervention and standard group (p < 0.0001) respectively. The incidence of POAF or VT/VF were similar in the intervention group and the standard group (30% [49 of 161 patients] and 30% [49 of 163 patients], absolute risk reduction 0.4%; 95% CI, - 9.6-10.4; p = 0.94). MACCE was similar between groups with, an occurrence of 24% and 21% for the intervention group and the standard groups (absolute risk reduction 3.4%; 95% CI, - 5.7-12.5; p = 0.47) respectively. After adjustment, the primary and secondary endpoints remained similar for both groups. CONCLUSION Hyperoxia did not decrease POAF and cardiovascular morbidity following cardiac surgery with CPB. CLINICALTRIAL. GOV IDENTIFIER NCT02819739.",2019,"MACCE was similar between groups with, an occurrence of 24% and 21% for the intervention group and the standard groups (absolute risk reduction 3.4%; 95% CI, - 5.7-12.5; p = 0.47) respectively.","['330 patients', 'adults undergoing elective cardiac surgery, i.e. cardiopulmonary bypass (CPB) randomized 1:1 to an intervention group or standard group at two French University Hospitals from June 2016 to October 2018', 'cardiac surgery']","['Hyperoxia', 'hyperoxia', 'oxygen level']","['occurrence of major adverse cardiovascular events (MACCE: in-hospital mortality, stroke, cardiac arrest, acute kidney injury, and mesenteric ischemia', 'POAF and cardiovascular morbidity', 'incidence of postoperative atrial fibrillation (POAF) and ventricular fibrillation', 'occurrence of POAF and/or ventricular tachycardia/ventricular fibrillation (VT/VF', 'incidence of POAF or VT/VF', 'MACCE', 'cardiovascular complications']","[{'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1412000', 'cui_str': 'Mesenteric Ischemia'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C0042514', 'cui_str': 'Tachycardia, Ventricular'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",330.0,0.148733,"MACCE was similar between groups with, an occurrence of 24% and 21% for the intervention group and the standard groups (absolute risk reduction 3.4%; 95% CI, - 5.7-12.5; p = 0.47) respectively.","[{'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Abou-Arab', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France. osama.abouarab@gmail.com.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Huette', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Martineau', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Beauvalot', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Dijon University Hospital, 14033, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Beyls', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Josse', 'Affiliation': 'Department of Clinical Research, Amiens Picardy University Hospital, 80054, Amiens, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Touati', 'Affiliation': 'Department of Cardiac Surgery, Amiens Picardy University Hospital, 80054, Amiens, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouchot', 'Affiliation': 'Department of Cardiac Surgery, Dijon University Hospital, 14033, Dijon, France.'}, {'ForeName': 'Belaïd', 'Initials': 'B', 'LastName': 'Bouhemad', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Dijon University Hospital, 14033, Dijon, France.'}, {'ForeName': 'Momar', 'Initials': 'M', 'LastName': 'Diouf', 'Affiliation': 'Department of Clinical Research, Amiens Picardy University Hospital, 80054, Amiens, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Lorne', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France.'}, {'ForeName': 'Pierre-Grégoire', 'Initials': 'PG', 'LastName': 'Guinot', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Dijon University Hospital, 14033, Dijon, France.'}]",Intensive care medicine,['10.1007/s00134-019-05761-4'] 1318,31628838,Effect of Endogenous Clostridioides difficile Toxin Antibodies on Recurrence of C. difficile Infection.,"BACKGROUND Endogenous antibodies (eAbs) against Clostridioides (Clostridium) difficile toxins may protect against recurrence of C. difficile infection (rCDI). This hypothesis was tested using placebo group data from MODIFY (Monoclonal Antibodies for C. difficile Therapy) I and II (NCT01241552 and NCT01513239, respectively), global, randomized phase 3 trials that assessed the efficacy and safety of the antitoxin monoclonal antibodies bezlotoxumab and actoxumab in participants receiving antibiotic therapy for CDI. METHODS A placebo infusion (normal saline) was administered on study day 1. Serum samples were collected on day 1, week 4, and week 12, and eAb-A and eAb-B titers were measured by 2 validated electrochemiluminescence immunoassays. Rates of initial clinical cure and rCDI were summarized by eAb titer category (low, medium, high) at each time point. RESULTS Serum eAb titers were available from a total of 773 participants. The proportion of participants with high eAb-A and eAb-B titers increased over time. Rates of initial clinical cure were similar across eAb titer categories. There was no correlation between eAb-A titers and rCDI rate at any time point. However, there was a negative correlation between rCDI and eAb-B titer on day 1 and week 4. rCDI occurred in 22% of participants with high eAb-B titers at baseline compared with 35% with low or medium titers (P = .015). CONCLUSIONS Higher eAb titers against toxin B, but not toxin A, were associated with protection against rCDI. These data are consistent with the observed efficacy of bezlotoxumab, and lack of efficacy of actoxumab, in the MODIFY trials. CLINICAL TRIALS REGISTRATION NCT01241552 and NCT01513239.",2020,"High titers of endogenous antibodies to Clostridioides difficile toxin B, but not toxin A, were associated with reduced recurrence of C. difficile infection.",['participants receiving antibiotic therapy for CDI'],"['antitoxin monoclonal antibodies bezlotoxumab and actoxumab', 'Endogenous Clostridioides difficile Toxin Antibodies', 'MODIFY (Monoclonal Antibodies for C. difficile Therapy', 'placebo', 'bezlotoxumab', 'placebo infusion (normal saline']","['rCDI', 'Rates of initial clinical cure and rCDI', 'eAb-A titers and rCDI rate', 'efficacy and safety', 'Rates of initial clinical cure', 'Recurrence of C. difficile Infection']","[{'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C0003445', 'cui_str': 'Antitoxins'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C4308583', 'cui_str': 'actoxumab'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",773.0,0.302785,"High titers of endogenous antibodies to Clostridioides difficile toxin B, but not toxin A, were associated with reduced recurrence of C. difficile infection.","[{'ForeName': 'Ciarán P', 'Initials': 'CP', 'LastName': 'Kelly', 'Affiliation': 'Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Poxton', 'Affiliation': 'University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Judong', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospitals and University of Leeds, United Kingdom.'}, {'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Omar F', 'Initials': 'OF', 'LastName': 'Laterza', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Railkar', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Dalya', 'Initials': 'D', 'LastName': 'Guris', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz809'] 1319,29654420,"Comparison of gingival depigmentation with Er,Cr:YSGG laser and surgical stripping, a 12-month follow-up.","Gingival melanin hyperpigmentation is an esthetic concern for many individuals. In this study, we compared the standard surgical removal method with two different Er,Cr:YSGG laser settings in order to find the best treatment method. In 33 dental arches, the following three treatment groups were comparatively evaluated: (1) surgical stripping, (2) removal with laser setting 1 (4.5 W, 50 Hz, 100% water, 80% air, 60 μs, 800 μm Tip; MZ8), and (3) laser setting 2 (2.5 W, 50 Hz, 20% water, 40% air, 700 μs, 800 μm Tip; MZ8). We comparatively evaluated pain, patient satisfaction and wound healing, treatment time, and the amount of bleeding. Re-pigmentation was evaluated after 1 and 12 months by Hedin and Dummet pigmentation scores. Laser setting 1 had the best results regarding pain and patient satisfaction, although not statistically significant (P > 0.05). Wound healing results were better using lasers compared to surgical stripping (P < 0.05). Laser setting 1 was a faster procedure with mild amounts of bleeding. The least amount of bleeding was seen with laser setting 2. After 1 month, only two cases of the laser setting 2-treated areas showed an isolated pigmented area in the papilla; at 12 months, the mean Hedin indexes were still less than 2 and mean Dummett index less than 1 in all treatment techniques, with the lowest scores seen in the laser setting 1 sites. Based on our results, Er,Cr:YSGG laser can be more convenient for gingival depigmentation compared to surgical blade. Although not statistically significant, laser setting 1 with shorter pulse duration and higher water spray showed better overall results. However, laser setting 2, with longer pulse duration and less water spray, resulted in better coagulative effects and can be used to control bleeding wherever necessary in clinical practice.",2018,"Laser setting 1 had the best results regarding pain and patient satisfaction, although not statistically significant (P > 0.05).",[],"['gingival depigmentation with Er,Cr:YSGG laser and surgical stripping', 'standard surgical removal method with two different Er,Cr:YSGG laser settings']","['pain and patient satisfaction', 'Wound healing results', 'isolated pigmented area in the papilla', 'mean Hedin indexes', 'least amount of bleeding', 'coagulative effects', 'pain, patient satisfaction and wound healing, treatment time, and the amount of bleeding', 'Re-pigmentation']",[],"[{'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0162835', 'cui_str': 'Hypomelanosis'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",,0.0202421,"Laser setting 1 had the best results regarding pain and patient satisfaction, although not statistically significant (P > 0.05).","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Gholami', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Somayeh Ansari', 'Initials': 'SA', 'LastName': 'Moghaddam', 'Affiliation': 'Oral and Dental research center, Department of Periodontology, Faculty of Dentistry, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mohammad Ayoub', 'Initials': 'MA', 'LastName': 'Rigi Ladiz', 'Affiliation': 'Oral and Dental research center, Department of Periodontology, Faculty of Dentistry, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Molai Manesh', 'Affiliation': 'Dentist, Oral and Dental research center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hashemzehi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran. Hashemzehi@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Fallah', 'Affiliation': 'Laser Dental Center, Aachen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Gutknecht', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, RWTH Aachen, Aachen, Germany.'}]",Lasers in medical science,['10.1007/s10103-018-2501-1'] 1320,31553471,Association of BCG Vaccination in Childhood With Subsequent Cancer Diagnoses: A 60-Year Follow-up of a Clinical Trial.,"Importance The BCG vaccine is currently the only approved tuberculosis vaccine and is widely administered worldwide, usually during infancy. Previous studies found increased rates of lymphoma and leukemia in BCG-vaccinated populations. Objective To determine whether BCG vaccination was associated with cancer rates in a secondary analysis of a BCG vaccine trial. Design, Setting, and Participants Retrospective review (60-year follow-up) of a clinical trial in which participants were assigned to the vaccine group by systematic stratification by school district, age, and sex, then randomized by alternation. The original study was conducted at 9 sites in 5 US states between December 1935 and December 1998. Participants were 2963 American Indian and Alaska Native schoolchildren younger than 20 years with no evidence of previous tuberculosis infection. Statistical analysis was conducted between August 2018 and July 2019. Interventions Single intradermal injection of either BCG vaccine or saline placebo. Main Outcomes and Measures The primary outcome was diagnosis of cancer after BCG vaccination. Data on participant interval health and risk factors, including smoking, tuberculosis infection, isoniazid use, and other basic demographic information, were also collected. Results A total of 2963 participants, including 1540 in the BCG vaccine group and 1423 in the placebo group, remained after exclusions. Vaccination occurred at a median (interquartile range) age of 8 (5-11) years; 805 participants (52%) in the BCG group and 710 (50%) in the placebo group were female. At the time of follow-up, 97 participants (7%) in the placebo group and 106 participants (7%) in the BCG vaccine group could not be located; total mortality was 633 participants (44%) in the placebo group and 632 participants (41%) in the BCG group. The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia. The rate of lung cancer was significantly lower in BCG vs placebo recipients (18.2 vs 45.4 cases per 100 000 person-years; hazard ratio, 0.38; 95% CI, 0.20-0.74; P = .005), controlling for sex, region, alcohol overuse, smoking, and tuberculosis. Conclusions and Relevance Childhood BCG vaccination was associated with a lower risk of lung cancer development in American Indian and Alaska Native populations. This finding has potentially important health implications given the high mortality rate associated with lung cancer and the availability of low-cost BCG vaccines.",2019,"The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia.","['A total of 2963 participants, including 1540 in the BCG vaccine group and 1423 in the placebo group, remained after exclusions', '9 sites in 5 US states between December 1935 and December 1998', 'Childhood With Subsequent Cancer Diagnoses', 'Participants were 2963 American Indian and Alaska Native schoolchildren younger than 20 years with no evidence of previous tuberculosis infection']","['BCG Vaccination', 'BCG vaccination', 'BCG vaccine or saline placebo', 'placebo', 'vaccine', 'BCG vaccine']","['located; total mortality', 'participant interval health and risk factors, including smoking, tuberculosis infection, isoniazid use, and other basic demographic information', 'overall rate of cancer diagnosis', 'rate of lung cancer', 'Vaccination', 'cancer rates', 'rates of lymphoma and leukemia', 'diagnosis of cancer after BCG vaccination']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]",805.0,0.459933,"The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia.","[{'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Usher', 'Affiliation': 'Infectious Diseases Division, Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Division of Vaccines and Related Product Applications, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Howard', 'Affiliation': 'Department of Research Programs, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Research Programs, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Harrison', 'Affiliation': 'Infectious Diseases Epidemiology Research Unit, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Health Systems Program, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Aronson', 'Affiliation': 'Infectious Diseases Division, Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12014'] 1321,29528960,Knee Kinetics During Squats of Varying Loads and Depths in Recreationally Trained Women.,"Flores, V, Becker, J, Burkhardt, E, and Cotter, J. Knee kinetics during squats of varying loads and depths in recreationally trained women. J Strength Cond Res 34(7): 1945-1952, 2020-The back squat exercise is typically practiced with varying squat depths and barbell loads. However, depth has been inconsistently defined, resulting in unclear safety precautions when squatting with loads. In addition, women exhibit anatomical and kinematic differences to men, which may predispose them to knee joint injuries. The purpose of this study was to characterize peak knee extensor moments (pKEMs) at 3 commonly practiced squat depths of above-parallel, parallel, and full depths, and with 3 loads of 0 (unloaded), 50, and 85% depth-specific 1 repetition maximum (1RM) in recreationally active women. Nineteen women (age, 25.1 ± 5.8 years; body mass, 62.5 ± 10.2 kg; height, 1.6 ± 0.10 m; mean ± SD) performed squats of randomized depth and load. Inverse dynamics were used to obtain pKEMs from 3-dimensional knee kinematics. Depth and load had significant interaction effects on pKEMs (p = 0.014). Significantly greater pKEMs were observed at full depth compared with parallel depth with 50% 1RM load (p = 0.001, d = 0.615) and 85% 1RM load (p = 0.010, d = 0.714). Greater pKEMs were also observed at full depth compared with above-parallel depth with 50% 1RM load (p = 0.003, d = 0.504). Results indicate that effect of load on female pKEMs do not follow a progressively increasing pattern with either increasing depth or load. Therefore, when high knee loading is a concern, individuals must carefully consider both the depth of squat being performed and the relative load they are using.",2020,"Significantly greater pKEMs were observed at full depth compared to parallel depth with 50% 1RM load (p = 0.001, d = 0.615), and 85% 1RM load (p = 0.010, d = 0.714).","['Nineteen females (age, 25.1 ± 5.8 years; body mass, 62.5 ± 10.2 kg; height, 1.6 ± 0.10 m; mean ± SD) performed squats of randomized depth and load', 'Recreationally Trained Females']",['back squat exercise'],['peak knee extensor moments (pKEMs'],"[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",,0.114981,"Significantly greater pKEMs were observed at full depth compared to parallel depth with 50% 1RM load (p = 0.001, d = 0.615), and 85% 1RM load (p = 0.010, d = 0.714).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flores', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': 'College of Education, Health, and Human Development, Montana State University, Bozeman, Montana.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Burkhardt', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, California.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cotter', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, California.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002509'] 1322,29469602,Can 5 minutes of repetitive prone press-ups and sustained prone press-ups following a period of spinal loading reverse spinal shrinkage?,"Objective : The objective of this study is to investigate if sustained and repetitive prone press-ups could reverse decreased spinal height following spinal loading and if there was a correlation between the degree of end range of motion spinal extension and spinal height gains. Design : Pretest-posttest crossover design is used in this study. Setting : Study was carried out in research laboratory. Subjects : Forty-one healthy men and women were included in this study. Intervention : Participants were seated in the stadiometer for 5 min with a 4.5-kg weight placed on each shoulder; the load was removed for 5 min and spinal height was measured using a stadiometer before and after 5 min of repetitive or sustained prone press-ups. Main Measures : Two-by-two repeated-measures ANOVA to identify significant interactions and main effects is used in this study. Significance of α  = 0.05. A Pearson correlation coefficient was used to assess the correlation between spinal height changes and spinal extension ROM. Results : Participants 24.1 ± 2.03 years grew using both repetitive (4.85 ± 3.01 mm) and sustained press ups (4.46 ± 2.57 mm). There was no significant interaction between the repetitive versus sustained press-ups and the time before and after each prone press-ups strategy and no main effect for strategy (sustained vs. repetitive press-ups). There was a significant main effect for time (before vs. after press-ups) ( F (1,30)  = 140.771; p  < 0.0001; partial η 2  = 0.82). No correlation was found between the degree of end ROM spinal extension and spinal height changes following press-ups strategies. Conclusion : Following periods of spinal loading, both repetitive and sustained press-ups increased spinal height. Such strategies could be used to help recover spinal height and limit the effects of decreased spinal height as a result of activities of daily living.",2019,There was no significant interaction between the repetitive versus sustained press-ups and the time before and after each prone press-ups strategy and no main effect for strategy (sustained vs. repetitive press-ups).,['Forty-one healthy men and women were included in this study'],[],"['spinal height changes and spinal extension ROM', 'degree of end ROM spinal extension and spinal height changes', 'spinal height']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",41.0,0.0284328,There was no significant interaction between the repetitive versus sustained press-ups and the time before and after each prone press-ups strategy and no main effect for strategy (sustained vs. repetitive press-ups).,"[{'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Munster', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Brismée', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Phillip S', 'Initials': 'PS', 'LastName': 'Sizer', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Browne', 'Affiliation': 'The University of Texas at El Paso, El Paso, TX, USA.'}, {'ForeName': 'Birendra', 'Initials': 'B', 'LastName': 'Dewan', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Litke', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Pape', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Sobczak', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1442539'] 1323,29461420,"Effect of Ibuprofen on Muscle, Hematological and Renal Function, Hydric Balance, Pain, and Performance During Intense Long-Distance Running.","de Souza, RF, de Matos, DG, Ferreira, ARP, Chilibeck, P, Barros, NdA, de Oliveira, AS, Cercato, LM, da Silva, DS, and Aidar, FJ. Effect of ibuprofen on muscle, hematological and renal function, hydric balance, pain, and performance during intense long-distance running. J Strength Cond Res 34(7): 2076-2083, 2020-The aim of this study was to investigate the effect of prophylactic use of nonsteroidal anti-inflammatory drugs (i.e., ibuprofen) on physical performance, vertical jump, muscle biomarkers, liver, kidney, acute pain, and hydration status of participants in the 42-km Trail Running Challenge, a long-distance race integrated over mountain routes. The sample consisted of 20 men randomly divided into 2 groups: a control group (CG) and an experimental group (EG), with 12 completing the race (41.1 ± 8.8 years; 75.7 ± 12.1 kg) and included in the final analysis. The EG were administered an ibuprofen capsule (400 mg) 15 minutes before the beginning of the race and again after 5 hours of racing if the route was not yet completed. There were significant time main effects for creatine kinase (p = 0.001; f Cohen = 0.25), lactate dehydrogenase (p < 0.001; f Cohen = 2.05), aspartate aminotransferase (p = 0.002; f Cohen = 1.53), creatinine (p = 0.002; f Cohen = 2.24), urea (p = 0.001; f Cohen = 2.25), heart rate (p < 0.001; f Cohen = 4.88), and pain scores (p < 0.001; f Cohen = 1.93) all of which increased during the race. There was a group × time interaction for squat jump, which significantly decreased only in the CG (p = 0.045; f Cohen = 2.17). This may have been related to increased frequency of pain reported after the race in the gastrocnemius of the CG compared with the EG (p ≤ 0.05). It was concluded that ibuprofen intake did not reduce muscle damage during the competition but maintained leg muscular power performance (i.e., vertical jump), possibly by reducing gastrocnemius muscle pain.",2020,"There were significant time main effects for creatine kinase (CK) (p=0.001; f Cohen=0.25), lactate dehydrogenase (LDH) (p<0.001; f Cohen=2.05), aspartate aminotransferase (AST) (p=0.002; f Cohen=1.53), creatinine (p=0.002; f Cohen=2.24), urea (p=0.001; f Cohen=2.25), heart rate (HR) (p<0.001; f Cohen=4.88) and pain scores (p<0.001; f Cohen=1.93) which all increased during the race.","['participants in the 42 km Trail Running Challenge, a long-distance race integrated over mountain routes']","['nonsteroidal anti-inflammatory drugs (NSAID, i.e. Ibuprofen', 'ibuprofen capsule', 'ibuprofen', 'control group (CG']","['gastrocnemius muscle pain', 'time interaction for squat jump (SJ', 'creatine kinase (CK', 'heart rate (HR', 'muscle, hematological and renal function, hydric balance, pain, and performance during intense long-distance running', 'pain scores', 'physical performance, vertical jump, muscle biomarkers, liver, kidney, acute pain and hydration status', 'lactate dehydrogenase (LDH', 'aspartate aminotransferase (AST']","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2607857'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}]",20.0,0.0674108,"There were significant time main effects for creatine kinase (CK) (p=0.001; f Cohen=0.25), lactate dehydrogenase (LDH) (p<0.001; f Cohen=2.05), aspartate aminotransferase (AST) (p=0.002; f Cohen=1.53), creatinine (p=0.002; f Cohen=2.24), urea (p=0.001; f Cohen=2.25), heart rate (HR) (p<0.001; f Cohen=4.88) and pain scores (p<0.001; f Cohen=1.93) which all increased during the race.","[{'ForeName': 'Raphael Fabricio', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Dihogo Gama', 'Initials': 'DG', 'LastName': 'de Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports-GEPEPS, the Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Alexandre Reis Pires', 'Initials': 'ARP', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Natalie de Almeida', 'Initials': 'NA', 'LastName': 'Barros', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports-GEPEPS, the Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Alan Santos', 'Initials': 'AS', 'LastName': 'Oliveira', 'Affiliation': 'Department of Physiology and Pharmacology Inflammatory Process, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Luana Mendonça', 'Initials': 'LM', 'LastName': 'Cercato', 'Affiliation': 'Department of Physiology and Pharmacology Inflammatory Process, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Danielle Soares', 'Initials': 'DS', 'LastName': 'da Silva', 'Affiliation': 'Research center and attention to worker health, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Felipe José', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002502'] 1324,29435849,Denosumab: A Review in Postmenopausal Osteoporosis.,"Denosumab (Prolia ® ; Pralia ® ) is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once every 6 months and is approved for various indications, including the treatment of postmenopausal (PM) women with osteoporosis at increased/high risk of fracture or failure/intolerance of other osteoporosis therapies (indications featured in this review). Denosumab showed benefit in several phase 3 or 4 studies in PM women with osteoporosis or low bone mineral density (BMD), including the pivotal 3-year double-blind FREEDOM trial and its 7-year open-label extension. Denosumab reduced the risk of vertebral, nonvertebral and hip fractures and increased BMD across skeletal sites versus placebo in FREEDOM, with these benefits maintained over up to 10 years' therapy in the extension. The drug was also more effective in improving BMD than bisphosphonates, including in women switched from a bisphosphonate regimen, in 1-year trials; however, whether these differences translate into differences in anti-fracture efficacy is unclear. Denosumab was generally well tolerated over up to 10 years' treatment, although an increased risk of multiple vertebral fractures was observed after discontinuation of the drug. Thus, denosumab is a key treatment option for PM women with osteoporosis who have an increased/high risk of fracture or failure/intolerance of other osteoporosis therapies, although the potential for multiple vertebral fractures to occur after discontinuation of the drug requires consideration of subsequent management options.",2018,"Denosumab reduced the risk of vertebral, nonvertebral and hip fractures and increased BMD across skeletal sites versus placebo in FREEDOM, with these benefits maintained over up to 10 years' therapy in the extension.","['postmenopausal (PM) women with osteoporosis at increased/high risk of fracture or failure/intolerance of other osteoporosis therapies (indications featured in this review', 'Postmenopausal Osteoporosis', 'PM women with osteoporosis or low bone mineral density (BMD', 'PM women with osteoporosis who have an increased/high risk of fracture or failure/intolerance of other osteoporosis therapies']","['denosumab', 'placebo', 'Denosumab', 'Denosumab (Prolia ® ; Pralia ® ']","['risk of vertebral, nonvertebral and hip fractures and increased BMD', 'risk of multiple vertebral fractures', 'BMD', 'tolerated']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0029694', 'cui_str': 'Other osteoporosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2917754', 'cui_str': 'Prolia'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}]",,0.0203466,"Denosumab reduced the risk of vertebral, nonvertebral and hip fractures and increased BMD across skeletal sites versus placebo in FREEDOM, with these benefits maintained over up to 10 years' therapy in the extension.","[{'ForeName': 'Emma D', 'Initials': 'ED', 'LastName': 'Deeks', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs & aging,['10.1007/s40266-018-0525-7'] 1325,31599035,Short-term numerosity training promotes symbolic arithmetic in children with developmental dyscalculia: The mediating role of visual form perception.,"Studies have shown that numerosity-based arithmetic training can promote arithmetic learning in typically developing children as well as children with developmental dyscalculia (DD), but the cognitive mechanism underlying this training effect remains unclear. The main aim of the current study was to examine the role of visual form perception in arithmetic improvement through an 8-day numerosity training for DD children. Eighty DD children were selected from four Chinese primary schools. They were randomly divided into the intervention and control groups. The intervention group received training on an apple-collecting game, whereas the control group received an English dictation task. Children's cognitive and arithmetic performances were assessed before and after training. The results showed that the intervention group showed a significant improvement in arithmetic performance, approximate number system (ANS) acuity, and visual form perception, but not in spatial processing and sentence comprehension. The control group showed no significant improvement in any cognitive ability. Mediation analysis further showed that training-related improvement in arithmetic performance was fully mediated by the improvement in visual form perception. The results suggest that short-term numerosity training enhances the arithmetic performance of DD children by improving their visual form perception.",2020,"The results showed that the intervention group showed a significant improvement in arithmetic performance, ANS acuity, and visual form perception, but not in spatial processing and sentence comprehension.","['DD children', 'children with developmental dyscalculia', 'children with developmental dyscalculia (DD', 'Eighty DD children were selected from four Chinese primary schools']","['Short-term numerosity training', 'numerosity-based arithmetic training', 'training on an apple-collecting game, whereas the control group received an English dictation task', 'short-term numerosity training']","[""Children's cognitive and arithmetic performance"", 'arithmetic performance', 'arithmetic performance, ANS acuity, and visual form perception, but not in spatial processing and sentence comprehension', 'cognitive ability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1395913', 'cui_str': 'Developmental Dyscalculia'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0016563', 'cui_str': 'Contour Perception'}, {'cui': 'C3850026', 'cui_str': 'Auditory Spatial Processing'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",80.0,0.0169951,"The results showed that the intervention group showed a significant improvement in arithmetic performance, ANS acuity, and visual form perception, but not in spatial processing and sentence comprehension.","[{'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'Chinese Teaching Department, Beijing Chinese Language and Culture College, Beijing, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA, USA.'}, {'ForeName': 'Jieying', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Business School, Beijing Wuzi University, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatric Neurology, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Xinlin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}]",Developmental science,['10.1111/desc.12910'] 1326,31587470,Racing dragons and remembering aliens: Benefits of playing number and working memory games on kindergartners' numerical knowledge.,"Sources that contribute to variation in mathematical achievement include both numerical knowledge and general underlying cognitive processing abilities. The current study tested the benefits of tablet-based training games that targeted each of these areas for improving the mathematical knowledge of kindergarten-age children. We hypothesized that playing a number-based game targeting numerical magnitude knowledge would improve children's broader numerical skills. We also hypothesized that the benefits of playing a working memory (WM) game would transfer to children's numerical knowledge given its important underlying role in mathematics achievement. Kindergarteners from diverse backgrounds (n = 148; 52% girls; M age  = 71.87 months) were randomly assigned to either play a number-based game, a WM game, or a control game on a tablet for 10 sessions. Structural equation modeling was used to model children's learning gains in mathematics and WM across time. Overall, our results suggest that playing the number game improved kindergarten children's numerical knowledge at the latent level, and these improvements remained stable as assessed 1 month later. However, children in the WM group did not improve their numerical knowledge compared to children in the control condition. Playing both the number game and WM game improved children's WM at the latent level. Importantly, the WM group continued to improve their WM for at least a month after playing the games. The results demonstrate that computerized games that target both domain-specific and domain-general skills can benefit a broad range of kindergarten-aged children.",2020,"Overall, our results suggest that playing the number game improved kindergarten children's numerical knowledge at the latent level, and these improvements remained stable as assessed one month later.","['Kindergarteners from diverse backgrounds (n\xa0=\xa0148; 52% girls; M age \xa0=\xa071.87\xa0months', 'kindergarten-age children', 'kindergarten-aged children']","['Playing Number and Working Memory Games', 'computerized games that target both domain-specific and domain-general skills', 'Structural equation modeling (SEM', 'play a number-based game, a WM game, or a control game']","[""number game improved kindergarten children's numerical knowledge"", 'numerical knowledge']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0369623,"Overall, our results suggest that playing the number game improved kindergarten children's numerical knowledge at the latent level, and these improvements remained stable as assessed one month later.","[{'ForeName': 'Geetha B', 'Initials': 'GB', 'LastName': 'Ramani', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'Daubert', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Grace C', 'Initials': 'GC', 'LastName': 'Lin', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Snigdha', 'Initials': 'S', 'LastName': 'Kamarsu', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Alaina', 'Initials': 'A', 'LastName': 'Wodzinski', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Jaeggi', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, CA, USA.'}]",Developmental science,['10.1111/desc.12908'] 1327,31624837,Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR).,"OBJECTIVE To examine the effects of filgotinib, an oral, selective Janus kinase 1 inhibitor, on health-related quality of life (HRQoL) using the Psoriatic Arthritis Impact of Disease (PsAID)9 questionnaire in active PsA. METHODS Patients were randomized 1 : 1 to filgotinib 200 mg or placebo once daily for 16 weeks in EQUATOR, a multicentre, double-blind, phase 2 randomized controlled trial. HRQoL was assessed with PsAID9 at Weeks 4 and 16. Change from baseline in total and individual domain scores, plus the proportions of patients achieving minimal clinically important improvement (MCII; ⩾3 points) and patient-accepted symptom status (PASS; score <4), were evaluated. Correlation with the 36-item short-form health survey (SF-36) was investigated. RESULTS One hundred and thirty-one patients were randomized to filgotinib or placebo. Filgotinib effects on PsAID9 were observed from Week 4. At Week 16, mean (s.d.) change from baseline in PsAID9 was -2.3 (1.8) and -0.8 (2.2) for filgotinib and placebo, respectively (least-squares mean of group difference -1.48 [95% CI -2.12, -0.84], P < 0.0001), with significant improvements in all domains vs placebo. Significantly more patients on filgotinib achieved MCII (group difference 25.4% [95% CI 8.92, 39.99], P = 0.0022) and PASS (group difference 29.6% [95% CI 10.65, 45.60], P = 0.0018) at Week 16 vs placebo. Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36. CONCLUSION Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9. To our knowledge, EQUATOR is the first randomized controlled trial to evaluate PsAID9. TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show, NCT03101670.",2020,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36. CONCLUSION Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","['Patients', 'One hundred and thirty-one patients', 'active psoriatic arthritis', 'patients with active PsA']","['placebo', 'filgotinib', 'filgotinib or placebo', 'filgotinib 200 mg or placebo']","['HRQoL', 'health-related quality of life', 'PsAID9', 'SF-36', 'filgotinib achieved MCII']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}]",131.0,0.800834,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36. CONCLUSION Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Rheumatology, Royal National Hospital for Rheumatic Diseases.'}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Department of Rheumatology & Immunology, Singapore General Hospital, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Meuleners', 'Affiliation': 'Biostatistics, Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Hendrikx', 'Affiliation': 'Medical Affairs, Galapagos BV, Leiden, Netherlands.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez408'] 1328,29489714,Effects of Combined Balance and Plyometric Training on Athletic Performance in Female Basketball Players.,"Bouteraa, I, Negra, Y, Shephard, RJ, and Chelly, MS. Effects of combined balance and plyometric training on athletic performance in female basketball players. J Strength Cond Res 34(7): 1967-1973, 2020-The purpose of this study was to examine the effect of 8 weeks combined balance and plyometric training on the physical fitness of female adolescent basketball players. Twenty-six healthy regional-level players were randomly assigned to either an experimental group (E; n = 16, age = 16.4 ± 0.5) or a control group (C; n = 10, age = 16.5 ± 0.5). C maintained their normal basketball training schedule, whereas for 8 weeks E replaced a part of their standard regimen by biweekly combined training sessions. Testing before and after training included the squat jump (SJ), countermovement jump (CMJ), drop jump (DJ), 5-, 10-, and 20-m sprints, Stork balance test (SBT), Y-balance test (YBT) and modified Illinois change of direction test (MICODT). Results indicated no significant intergroup differences in SJ and CMJ height; however, E increased their DJ height (p < 0.05, Cohens'd = 0.11). No significant intergroup differences were found for sprint performance or SBT, but dynamic YBT tended to a significant group interaction (p = 0.087, d = 0.006). Post hoc analysis also showed a significant increase of MICODT for E (Δ 6.68%, p = 0.041, d = 0.084). In summary, the addition of 8 weeks of balance and plyometric training to regular in-season basketball training proved a safe and feasible intervention that enhanced DJ height, balance, and agility for female adolescent basketball players relative to the standard basketball training regimen.",2020,"No significant inter-group differences were found for sprint performance or SBT, but dynamic YBT tended to a significant group interaction (p = 0.087, d = 0.006).","['female adolescent basketball players', 'Twenty six healthy regional-level players', 'female basketball players']","['combined balance and plyometric training', 'plyometric training to regular in-season basketball training']","['sprint performance or SBT, but dynamic YBT', 'SJ and CMJ height', 'Squat Jump (SJ), Countermovement Jump (CMJ), Drop Jump (DJ), 5, 10 and 20-m sprints, Stork Balance Test (SBT), Y-Balance Test (YBT) and Modified Illinois Change of Direction Test (MICODT', 'DJ height, balance, and agility', 'DJ height', 'athletic performance']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0325459', 'cui_str': 'Stork'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]",26.0,0.0116676,"No significant inter-group differences were found for sprint performance or SBT, but dynamic YBT tended to a significant group interaction (p = 0.087, d = 0.006).","[{'ForeName': 'Ichrak', 'Initials': 'I', 'LastName': 'Bouteraa', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba,"" Tunis, Tunisia.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba,"" Tunis, Tunisia.'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba,"" Tunis, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002546'] 1329,29385007,Alcohol After Resistance Exercise Does Not Affect Muscle Power Recovery.,"Levitt, DE, Idemudia, NO, Cregar, CM, Duplanty, AA, Hill, DW, and Vingren, JL. Alcohol after resistance exercise does not affect muscle power recovery. J Strength Cond Res 34(7): 1938-1944, 2020-The purpose of this study was to investigate the effect of alcohol consumed after heavy eccentric resistance exercise on measures of muscle power. After familiarization and an initial eccentric exercise bout to control for the ""repeated-bout effect,"" 10 recreationally resistance-trained men completed 2 identical heavy eccentric squat bouts (4 sets of 10 repetitions at 110% of concentric 1-repetition maximum) 1 week apart. Each exercise bout was followed by ingestion of a beverage containing either alcohol (1.09 g ethanol·kg fat-free body mass) or no alcohol (placebo; volume of alcohol replaced with water). Vertical jump (VJ) peak power, VJ peak force, VJ jump height, change-of-direction ability (shuttle run), sprint acceleration (sprint test), and muscle soreness were measured before (PRE), 24 hours after (24H), and 48 hours after (48H) each eccentric exercise bout. Although the exercise bout resulted in significantly (p ≤ 0.05) decreased VJ peak power at 24H, significantly decreased VJ jump height at 24H, and significantly increased muscle soreness at 24H and 48H, consuming alcohol after the exercise bout did not affect any of the performance outcome measures. When consumed after a non-novel heavy eccentric resistance exercise bout, alcohol did not affect soreness or recovery of muscular power. Practitioners can use this information to advise their athletes with regard to responsible alcohol use after non-novel exercise. Although short-term anaerobic performance does not seem compromised as a result of acute postexercise alcohol ingestion, practitioners and athletes should be aware of potential long-term effects of such alcohol use.",2020,"Although the exercise bout resulted in significantly (p < 0.05) decreased VJ peak power at 24H, significantly decreased VJ jump height at 24H, and significantly increased muscle soreness at 24H and 48H, consuming alcohol after the exercise bout did not affect any of the performance outcome measures.",[],"['exercise bout was followed by ingestion of a beverage containing either alcohol (1.09 g ethanol[BULLET OPERATOR]kg fat-free body mass) or no alcohol (placebo; volume of alcohol replaced with water', 'initial eccentric exercise bout to control for the ""repeated-bout effect,"" ten recreationally resistance-trained men completed two identical heavy eccentric squat bouts', 'alcohol consumed after heavy eccentric resistance exercise', 'Alcohol after Resistance Exercise']","['VJ peak power', 'VJ jump height', 'Vertical jump (VJ) peak power, VJ peak force, VJ jump height, change-of-direction ability (shuttle run), sprint acceleration (sprint test), and muscle soreness', 'measures of muscle power', 'soreness or recovery of muscular power', 'muscle soreness']",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4517490', 'cui_str': '1.09 (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}]",,0.030715,"Although the exercise bout resulted in significantly (p < 0.05) decreased VJ peak power at 24H, significantly decreased VJ jump height at 24H, and significantly increased muscle soreness at 24H and 48H, consuming alcohol after the exercise bout did not affect any of the performance outcome measures.","[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Levitt', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Nosakhare O', 'Initials': 'NO', 'LastName': 'Idemudia', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Carianne M', 'Initials': 'CM', 'LastName': 'Cregar', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Duplanty', 'Affiliation': ""Department of Kinesiology, Texas Woman's University, Denton, Texas.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hill', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Jakob L', 'Initials': 'JL', 'LastName': 'Vingren', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002455'] 1330,29891538,Antitumor Activity Associated with Prolonged Persistence of Adoptively Transferred NY-ESO-1 c259 T Cells in Synovial Sarcoma.,"We evaluated the safety and activity of autologous T cells expressing NY-ESO-1 c259 , an affinity-enhanced T-cell receptor (TCR) recognizing an HLA-A2-restricted NY-ESO-1/LAGE1a-derived peptide, in patients with metastatic synovial sarcoma (NY-ESO-1 c259 T cells). Confirmed antitumor responses occurred in 50% of patients (6/12) and were characterized by tumor shrinkage over several months. Circulating NY-ESO-1 c259 T cells were present postinfusion in all patients and persisted for at least 6 months in all responders. Most of the infused NY-ESO-1 c259 T cells exhibited an effector memory phenotype following ex vivo expansion, but the persisting pools comprised largely central memory and stem-cell memory subsets, which remained polyfunctional and showed no evidence of T-cell exhaustion despite persistent tumor burdens. Next-generation sequencing of endogenous TCRs in CD8 + NY-ESO-1 c259 T cells revealed clonal diversity without contraction over time. These data suggest that regenerative pools of NY-ESO-1 c259 T cells produced a continuing supply of effector cells to mediate sustained, clinically meaningful antitumor effects. Significance: Metastatic synovial sarcoma is incurable with standard therapy. We employed engineered T cells targeting NY-ESO-1, and the data suggest that robust, self-regenerating pools of CD8 + NY-ESO-1 c259 T cells produce a continuing supply of effector cells over several months that mediate clinically meaningful antitumor effects despite prolonged exposure to antigen. Cancer Discov; 8(8); 944-57. ©2018 AACR. See related commentary by Keung and Tawbi, p. 914 This article is highlighted in the In This Issue feature, p. 899 .",2018,Circulating NY-ESO-1 c259 T cells were present postinfusion in all patients and persisted for at least 6 months in all responders.,"['Cancer Discov; 8(8); 944-57', 'Synovial Sarcoma', 'patients with metastatic synovial sarcoma (NY-ESO-1 c259 T cells']",[],"['Circulating NY-ESO-1 c259 T cells', 'antitumor responses', 'Antitumor Activity']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0039101', 'cui_str': 'Synovioma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",[],"[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",914.0,0.0417299,Circulating NY-ESO-1 c259 T cells were present postinfusion in all patients and persisted for at least 6 months in all responders.,"[{'ForeName': 'Sandra P', 'Initials': 'SP', 'LastName': ""D'Angelo"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York. E-mail:dangelos@mskcc.org.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Melchiori', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Merchant', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glod', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Rosandra', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Grupp', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chagin', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Gwendolyn K', 'Initials': 'GK', 'LastName': 'Binder', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Samik', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Lowther', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Ruoxi', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bath', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Tipping', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Betts', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Ramachandran', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Navenot', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Wells', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Winkle', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Kari', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Trupti', 'Initials': 'T', 'LastName': 'Trivedi', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Holdich', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Lini', 'Initials': 'L', 'LastName': 'Pandite', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Amado', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Mackall', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}]",Cancer discovery,['10.1158/2159-8290.CD-17-1417'] 1331,29523415,Combined Analysis of Mifepristone for Psychotic Depression: Plasma Levels Associated With Clinical Response.,"BACKGROUND Patients with psychotic depression exhibit elevated cortisol levels. Competitively antagonizing cortisol at the glucocorticoid receptor with mifepristone demonstrated therapeutic benefit in early studies of patients with psychotic depression. We present a combined analysis of all controlled phase 2 and 3 studies to report antipsychotic differences between treatment with mifepristone or placebo and to evaluate the relative contributions to response of attaining an a priori-defined, high mifepristone plasma level and markers of glucocorticoid receptor antagonism (increases in adrenocorticotropin hormone and cortisol) with treatment. METHODS Data from five similarly designed double-blind phase 2 or 3 studies evaluating the efficacy and safety of 7-day treatment with mifepristone for the psychotic symptoms of psychotic depression were pooled for analysis (mifepristone n = 833; placebo n = 627). Clinical assessments were performed at baseline and on days 7, 14, 28, 42, and 56. Mifepristone, adrenocorticotropin hormone, and cortisol samples were collected at baseline and day 7. RESULTS Combined results demonstrated meaningful efficacy (p < .004) for mifepristone in reducing psychotic symptoms with wide safety margins. Patients in the a priori-defined, high mifepristone plasma level group (≥1637 ng/mL) demonstrated a more significant treatment effect over placebo (p = .0004). A number needed to treat of 7 and 48 was observed in the high and low mifepristone plasma level groups, respectively. Adverse events were similar in mifepristone- and placebo-treated patients. CONCLUSIONS A high mifepristone plasma level carried the strongest association with response, followed by changes in adrenocorticotropin hormone and cortisol. Therapeutic plasma levels of mifepristone were most likely to be achieved with the 1200 mg/day dose.",2018,"RESULTS Combined results demonstrated meaningful efficacy (p < .004) for mifepristone in reducing psychotic symptoms with wide safety margins.","['Patients with psychotic depression exhibit elevated cortisol levels', 'patients with psychotic depression', 'n\xa0= 627']","['Mifepristone', 'mifepristone or placebo', 'placebo', 'mifepristone']","['Adverse events', 'psychotic symptoms', 'psychotic symptoms of psychotic depression', 'Mifepristone, adrenocorticotropin hormone, and cortisol samples', 'efficacy and safety', 'meaningful efficacy', 'Therapeutic plasma levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.326391,"RESULTS Combined results demonstrated meaningful efficacy (p < .004) for mifepristone in reducing psychotic symptoms with wide safety margins.","[{'ForeName': 'Thaddeus S', 'Initials': 'TS', 'LastName': 'Block', 'Affiliation': 'Corcept Therapeutics, Inc, Menlo Park, California; Stanford University School of Medicine, Stanford, California. Electronic address: tblock@corcept.com.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Kushner', 'Affiliation': 'Biomedical Computer Research Institute, Inc, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ned', 'Initials': 'N', 'LastName': 'Kalin', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health - Madison, Madison, Wisconsin.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Belanoff', 'Affiliation': 'Corcept Therapeutics, Inc, Menlo Park, California; Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}]",Biological psychiatry,['10.1016/j.biopsych.2018.01.008'] 1332,31493695,How much of the effect of exercise and advice for subacute low back pain is mediated by depressive symptoms?,"BACKGROUND Exercise and advice can reduce pain and disability in patients with subacute low back pain. However, the mechanisms by which this combined intervention works are unclear. Our objective was to estimate how much of the effect of a physiotherapist-directed exercise and advice intervention on pain and disability is mediated via changes in depressive symptoms. METHODS Causal mediation analysis of a randomized controlled trial. We measured our hypothesized mediator - depressive symptoms (Depression, Anxiety, Stress Scale-21) at 6 weeks, and the outcomes - pain (numerical rating scale) and disability (Roland Morris Disability Questionnaire) at 3 months, estimating the average causal mediation effect (ACME), average direct effect (ADE), and total effect. We pre-specified a causal model to identify potential confounders of the mediator-outcome effect and conducted sensitivity analyses to assess the robustness of the ACME under varying levels of unknown confounding. RESULTS Data from 240 patients were analyzed (average age 50.5 (SD 15.6) years, 52% male, median depressive symptoms score 4). The effect of exercise combined with advice was not mediated via depressive symptoms: ACME on pain (0.05, 95%CI -0.24 to 0.15), ACME on disability (-0.10, 95%CI -0.59 to 0.38). However depressive symptoms were associated with pain (regression coefficient 0.06; SE 0.03)) and disability (regression coefficient 0.17; SE 0.05).) CONCLUSIONS: Depressive symptoms did not mediate the effect of exercise and/or advice in this sample. However, depressive symptoms were associated with pain and disability.",2019,"The effect of exercise combined with advice was not mediated via depressive symptoms: ACME on pain (0.05, 95%CI -0.24 to 0.15), ACME on disability (-0.10, 95%CI -0.59 to 0.38).","['patients with subacute low back pain', 'Data from 240 patients were analyzed (average age 50.5 (SD 15.6) years, 52% male, median depressive symptoms score 4']","['exercise and advice', 'Exercise and advice', 'physiotherapist-directed exercise and advice intervention', 'ACME']","['pain and disability', 'Depressive symptoms', 'depressive symptoms', 'average causal mediation effect (ACME), average direct effect (ADE), and total effect', 'mediator - depressive symptoms (Depression, Anxiety, Stress Scale-21', 'pain', 'outcomes - pain (numerical rating scale) and disability (Roland Morris Disability Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",240.0,0.36918,"The effect of exercise combined with advice was not mediated via depressive symptoms: ACME on pain (0.05, 95%CI -0.24 to 0.15), ACME on disability (-0.10, 95%CI -0.59 to 0.38).","[{'ForeName': 'Vera Ae', 'Initials': 'VA', 'LastName': 'Baadjou', 'Affiliation': 'Adelante Centre of Expertise in Rehabilitation and Audiology, Hoensbroek, the Netherlands; Department of Rehabilitation Medicine, School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands. Electronic address: vera.baadjou@maastrichtuniversity.nl.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; School of Medicine and Public Health, The University of Newcastle, Newcastle, NSW, Australia; Hunter Medical Research Institute, Newcastle, NSW, Australia; Centre for Pain, Health and Lifestyle, Australia.'}, {'ForeName': 'Rob Jem', 'Initials': 'RJ', 'LastName': 'Smeets', 'Affiliation': 'Department of Rehabilitation Medicine, School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands; Libra Rehabilitation and Audiology, Eindhoven/Weert, the Netherlands.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Kamper', 'Affiliation': 'Centre for Pain, Health and Lifestyle, Australia; Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, Australia.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2019.102055'] 1333,31899170,Cost-Effectiveness of Three Doses of a Behavioral Intervention to Prevent or Delay Type 2 Diabetes in Rural Areas.,"BACKGROUND Rural Americans have higher prevalence of obesity and type 2 diabetes (T2D) than urban populations and more limited access to behavioral programs to promote healthy lifestyle habits. Descriptive evidence from the Rural Lifestyle Intervention Treatment Effectiveness trial delivered through local cooperative extension service offices in rural areas previously identified that behavioral modification with both nutrition education and coaching resulted in a lower program delivery cost per kilogram of weight loss maintained at 2-years compared with an education-only comparator intervention. OBJECTIVE This analysis extended earlier Rural Lifestyle Intervention Treatment Effectiveness trial research regarding weight loss outcomes to assess whether nutrition education with behavioral coaching delivered through cooperative extension service offices is cost-effective relative to nutrition education only in reducing T2D cases in rural areas. DESIGN A cost-utility analysis was conducted. PARTICIPANTS/SETTING Trial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy. INTERVENTION Trial participants were randomly assigned to low, moderate, or high doses of behavioral coaching with nutrition education (ie, 16, 32, or 48 sessions over 24 months) or a comparator intervention that included 16 sessions of nutrition education without coaching. Participant glycated hemoglobin level was measured at baseline and the end of the trial to assess T2D status. MAIN OUTCOME MEASURES T2D categories by treatment arm were used to estimate participants' expected annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon. Discounted incremental costs and QALYs were used to calculate incremental cost-effectiveness ratios for each behavioral coaching intervention dose relative to the education-only comparator. STATISTICAL ANALYSES PERFORMED Using a third-party payer perspective, Markov transition matrices were used to model participant transitions between T2D states. Replications of the individual participant behavior were conducted using Monte Carlo simulation. RESULTS All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator. The moderate dose behavioral coaching intervention was associated with higher estimated QALYs but was costlier than the low dose; the moderate dose was favored over the low dose with willingness to pay thresholds over $107,895/QALY. The low dose behavioral coaching intervention was otherwise favored. CONCLUSIONS Because most rural Americans live in counties with cooperative extension service offices, nutrition education with behavioral coaching programs similar to those delivered through this trial may be effective and efficient in preventing or delaying T2D-associated consequences of obesity for rural adults.",2020,All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator.,"['T2D cases in rural areas', 'rural Americans live in counties with cooperative extension service offices', 'Rural Americans', 'Delay Type 2 Diabetes in Rural Areas', 'Trial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy', 'rural adults']","['comparator intervention that included 16 sessions of nutrition education without coaching', 'behavioral coaching intervention', 'behavioral coaching with nutrition education', 'Behavioral Intervention']","['annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon', 'total costs', 'Participant glycated hemoglobin level', 'Cost-Effectiveness']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2014.0,0.0572379,All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator.,"[{'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Radcliff', 'Affiliation': ''}, {'ForeName': 'Murray J', 'Initials': 'MJ', 'LastName': 'Côté', 'Affiliation': ''}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Daniels', 'Affiliation': ''}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Bobroff', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Janicke', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.10.025'] 1334,29570574,Sequencing Effects of Plyometric Training Applied Before or After Regular Soccer Training on Measures of Physical Fitness in Young Players.,"Ramirez-Campillo, R, Alvarez, C, Gentil, P, Loturco, I, Sanchez-Sanchez, J, Izquierdo, M, Moran, J, Nakamura, FY, Chaabene, H, and Granacher, U. Sequencing effects of plyometric training applied before or after regular soccer training on measures of physical fitness in young players. J Strength Cond Res 34(7): 1959-1966, 2020-To compare the effects of short-term (i.e., 7 weeks) plyometric jump training applied before (PJT-B) or after (PJT-A) soccer practice on components of physical fitness in young soccer players, a single-blind randomized controlled trial was conducted. Postpubertal boys aged 17.0 ± 0.5 years were allocated to 3 groups: PJT-B (n = 12), PJT-A (n = 14), and control (CON; n = 12). The outcome measures included tests to evaluate 20-m speed, standing long jump (SLJ), squat jump (SJ), countermovement jump (CMJ), and drop jump (DJ), 20-m multistage shuttle run endurance (MSSRT), and Illinois change-of-direction speed (ICODT). Although the CON performed soccer-specific training, the PJT-A and PJT-B groups conducted the same soccer-specific sessions but replaced ∼11% of their time with plyometric training. The PJT-B group performed plyometric exercises after a warm-up program, and the PJT-A group conducted plyometric exercises ∼10 minutes after the completion of soccer training. Analyses of variance were used to detect differences between groups in all variables for pretraining and posttraining tests. Main effects of time (all p < 0.01; d = 0.19-0.79) and group × time interactions (all p ≤ 0.05; d = 0.17-0.76) were observed for all examined variables. Post hoc analyses revealed significant increases in the PJT-B group (SLJ: 9.4%, d = 1.7; CMJ: 11.2%, d = 0.75; 20-m MSSRT: 9.0%, d = 0.77) and the PJT-A group (SLJ: 3.1%, d = 0.7; CMJ: 4.9%, d = 0.27; 20-m MSSRT: 9.0%, d = 0.76). Post hoc analyses also revealed significant increases in the PJT-B group (20-m speed: -7.4%, d = 0.75; 20-cm DJ reactive strength index: 19.1%, d = 1.4; SJ: 6.3%, d = 0.44; ICODT results: -4.2%, d = 1.1). In general, our study revealed that plyometric training is effective in improving measures of physical fitness in young male soccer players when combined with regular soccer training. More specifically, larger training-induced effects on physical fitness were registered if plyometric training was conducted before soccer-specific training.",2020,Main effects of time (all p<.01; d=0.19-0.79) and group x time interactions (all p<.05; d=0.17-0.76) were observed for all examined variables.,"['Young Players', 'Post-pubertal boys aged 17.0±0.5 years', 'young soccer players', 'young male soccer players']","['plyometric training', 'PJT-A group conducted plyometric exercises ∼10 minutes after the completion of soccer training', 'plyometric exercises', 'Plyometric Training Applied Before or After Regular Soccer Training', 'plyometric training applied before (PJT-B) or after (PJT-A) soccer practice']","['physical fitness', 'Physical Fitness', 'tests to evaluate 20-m speed, standing long jump [SLJ], squat jump [SJ], countermovement jump [CMJ], and drop jump [DJ], 20-m multistage shuttle running speed [MSSRT], and Illinois change of direction speed [ICODT', '20-cm DJ reactive strength index']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1626404', 'cui_str': 'Post-pubertal'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.012117,Main effects of time (all p<.01; d=0.19-0.79) and group x time interactions (all p<.05; d=0.17-0.76) were observed for all examined variables.,"[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, Universidad de Los (University of Los Lagos), Lagos, Osorno, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, Universidad de Los (University of Los Lagos), Lagos, Osorno, Chile.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goias, Goiânia, Brazil.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'Nucleus of High Performance in Sport (NAR), São Paulo, Brazil.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanchez-Sanchez', 'Affiliation': 'Research Group Planning and Assessment of Training and Athletic Performance, Pontifical University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarre, Navarra, Spain.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moran', 'Affiliation': 'Department of Sport, University Center Hartpury, University of the West of England, Bristol, United Kingdom.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'The College of Healthcare Sciences, James Cook University, Queensland, Australia.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'High Institute of Sports and Physical Education, University of Jendouba, El Kef, Tunisia.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002525'] 1335,29507824,Similar acute physiological responses from effort and duration matched leg press and recumbent cycling tasks.,"The present study examined the effects of exercise utilising traditional resistance training (leg press) or 'cardio' exercise (recumbent cycle ergometry) modalities upon acute physiological responses. Nine healthy males underwent a within session randomised crossover design where they completed both the leg press and recumbent cycle ergometer conditions. Conditions were approximately matched for effort and duration (leg press: 4 × 12RM using a 2 s concentric and 3 s eccentric repetition duration controlled with a metronome, thus each set lasted  60 s; recumbent cycle ergometer: 4 × 60 s bouts using a resistance level permitting 80-100 rpm but culminating with being unable to sustain the minimum cadence for the final 5-10 s). Measurements included VO 2 , respiratory exchange ratio (RER), blood lactate, energy expenditure, muscle swelling, and electromyography. Perceived effort was similar between conditions and thus both were well matched with respect to effort. There were no significant effects by 'condition' in any of the physiological responses examined (all p  > 0.05). The present study shows that, when both effort and duration are matched, resistance training (leg press) and 'cardio' exercise (recumbent cycle ergometry) may produce largely similar responses in VO 2 , RER, blood lactate, energy expenditure, muscle swelling, and electromyography. It therefore seems reasonable to suggest that both may offer a similar stimulus to produce chronic physiological adaptations in outcomes such as cardiorespiratory fitness, strength, and hypertrophy. Future work should look to both replicate the study conducted here with respect to the same, and additional physiological measures, and rigorously test the comparative efficacy of effort and duration matched exercise of differing modalities with respect to chronic improvements in physiological fitness.",2018,There were no significant effects by 'condition' in any of the physiological responses examined (all p  > 0.05).,"['60', 'Nine healthy males']","['leg press and recumbent cycle ergometer conditions', 'recumbent cycle ergometer: 4\xa0×', ""resistance training (leg press) and 'cardio' exercise (recumbent cycle ergometry"", ""exercise utilising traditional resistance training (leg press) or 'cardio' exercise (recumbent cycle ergometry) modalities""]","['VO 2 , respiratory exchange ratio (RER), blood lactate, energy expenditure, muscle swelling, and electromyography', 'VO 2 , RER, blood lactate, energy expenditure, muscle swelling, and electromyography']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",9.0,0.0182387,There were no significant effects by 'condition' in any of the physiological responses examined (all p  > 0.05).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'School of Sport, Health, and Social Sciences, Southampton Solent University, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Butler', 'Affiliation': 'School of Sport, Health, and Social Sciences, Southampton Solent University, United Kingdom.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Comerford', 'Affiliation': 'School of Sport, Health, and Social Sciences, Southampton Solent University, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Dyer', 'Affiliation': 'School of Sport, Health, and Social Sciences, Southampton Solent University, United Kingdom.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Lloyd', 'Affiliation': 'School of Sport, Health, and Social Sciences, Southampton Solent University, United Kingdom.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'School of Sport, Health, and Social Sciences, Southampton Solent University, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'School of Sport, Health, and Social Sciences, Southampton Solent University, United Kingdom.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'Faculty of Physical Education, Federal University of Goiás, Brazil.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'Department of Exercise, Health, and Sport Sciences, University of Southern Maine, United States of America.'}, {'ForeName': 'Hayao', 'Initials': 'H', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Health and Sports Science, Jutendo University, Japan.'}]",PeerJ,['10.7717/peerj.4403'] 1336,31630089,Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT).,"BACKGROUND One-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP. METHODS 206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6-8 weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models. RESULTS CFT reduced disability more than the group intervention at 6 months (mean difference, 8.65; 95% CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95% CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056) or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134). CONCLUSION CFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients. TRIAL REGISTRATION NUMBER ClinicalTrials.gov registry (NCT02145728).",2020,An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT).,"['206 adults with CLBP', 'chronic low back pain']","['Cognitive functional therapy compared with a group-based exercise and education intervention', 'CFT', 'physiotherapist-delivered individualised intervention (CFT', 'physiotherapist-delivered group-based exercise and education', 'individualised intervention called cognitive functional therapy (CFT', 'CFT (n=106) or group-based exercise and education']","['pain intensity', 'disability and pain intensity', 'disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",206.0,0.198245,An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT).,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'Institute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia mary.okeeffe@sydney.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Shenton Park, Perth, Western Australia, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Purtill', 'Affiliation': 'Department of Mathematics & Statistics, Faculty of Science & Engineering, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Bargary', 'Affiliation': 'Department of Mathematics & Statistics, Faculty of Science & Engineering, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}]",British journal of sports medicine,['10.1136/bjsports-2019-100780'] 1337,31860632,Oral Health-Related Quality of Life and the Use of Oral and Topical Nonsteroidal Anti-Inflammatory Drugs for Pericoronitis.,"BACKGROUND Pericoronitis is inflammation of the tissue surrounding a third molar, or wisdom tooth. This study aimed to evaluate the effects of oral and topical analgesic nonsteroidal anti-inflammatory drugs (NSAIDs) on oral health-related quality of life (OHQoL), in terms of oral health and lifestyle, in patients with symptomatic pericoronitis. MATERIAL AND METHODS The study included 60 patients who presented with pericoronitis and who did not undergo surgery within the following seven days. The patients were randomly assigned to three groups and were treated with oral diclofenac (N=20), oral flurbiprofen (N=20), and topical benzydamine (N=20). OHQoL was assessed for all study participants with a self-reported eight-item scale that was developed to evaluate pericoronitis. The total OHQoL scores were calculated for each day during the seven-day study period. RESULTS The study group treated with topical benzydamine had a significantly greater improvement in the OHQoL scores compared with the oral diclofenac and oral flurbiprofen groups on the first four days. Comparison of patients treated with diclofenac and flurbiprofen showed no significant differences for all seven days. A significant initial improvement in OHQoL was found on day 1 for the benzydamine group, on day 2 for the flurbiprofen group, and day 3 for the diclofenac group. CONCLUSIONS In this study, topical benzydamine was found to be a more effective alternative to oral NSAID analgesics, diclofenac and flurbiprofen, in improving OHQoL in patients with pericoronitis.",2019,The study group treated with topical benzydamine had a significantly greater improvement in the OHQoL scores compared with the oral diclofenac and oral flurbiprofen groups on the first four days.,"['patients with pericoronitis', '60 patients who presented with pericoronitis and who did not undergo surgery within the following seven days', 'patients with symptomatic pericoronitis']","['benzydamine', 'oral diclofenac', 'diclofenac', 'oral flurbiprofen', 'flurbiprofen', 'topical benzydamine', 'diclofenac and flurbiprofen', 'oral and topical analgesic nonsteroidal anti-inflammatory drugs (NSAIDs']","['OHQoL scores', 'oral health-related quality of life (OHQoL', 'OHQoL', 'total OHQoL scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031055', 'cui_str': 'Pericoronitis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",60.0,0.0217708,The study group treated with topical benzydamine had a significantly greater improvement in the OHQoL scores compared with the oral diclofenac and oral flurbiprofen groups on the first four days.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alalwani', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Near East University, Nicosia, Mersin, Turkey.'}, {'ForeName': 'Oğuz', 'Initials': 'O', 'LastName': 'Buhara', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Near East University, Nicosia, Mersin, Turkey.'}, {'ForeName': 'Mustafa Şenol', 'Initials': 'MŞ', 'LastName': 'Tüzüm', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Near East University, Nicosia, Mersin, Turkey.'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.918085'] 1338,31618177,Acute effects of essential oil blend containing phlai oil on mood among healthy male volunteers: Randomized controlled trial.,"Background Essential oil blend (ESOB) containing Zingiber montanum or Phlai and Zingiber tenuiscapus oils as the major components has high levels of terpenes such as sabinene, terpinene, terpinolene, and terpine-4-ol. Phlai is well known for its analgesic property, but its effects on mood remain unclear. This study aimed to investigate the acute effects of inhaling the ESOB containing phlai essential oils on mood and stress among healthy volunteers. Methods A prospective, randomized, double-blinded, controlled trial pilot study was conducted among 38 healthy male volunteers; 19 in the ESOB containing phlai oil group and 19 in the control group, which used olive oil. One single inhalation was provided continuously for 15 min via hot steam. Mood status was assessed pre- and post-intervention using the Visual Analog Scales for Mood, Anxiety, Stress and Alertness (MASA). Rorschach tests, in a modified analysis, were also employed. One-way ANCOVA was used to determine statistical differences of the mood test results between ESOB containing phlai oil and olive oil. Results Mean age of the participants was 22.11 (SD 2.1) years. Both ESOB containing phlai oil and olive oil increased the post-test scores of positive mood and reduced the scores of negative mood. However, no difference was observed regarding the mood test scores between groups, except concerning the Rorschach stress test (F (1,38)=6.486, p=0.015). The variance of change, explained by the model (R square), was 32.8%, while the adjusted R-squared was 0.290. Conclusions Single inhalation aromatherapy using ESOB containing phlai oil or olive oil showed an immediate improvement of mood states among healthy young male volunteers by easing the negative emotions and enhancing positive emotions, especially feelings of pleasure and contentment. Natural blend of phlai essential oils was more efficacious than olive oil in reducing emotional stress.",2019,"However, no difference was observed regarding the mood test scores between groups, except concerning the Rorschach stress test (F (1,38)=6.486, p=0.015).","['38 healthy male volunteers; 19 in the ESOB containing phlai oil group and 19 in the control group, which used olive oil', 'healthy young male volunteers', 'healthy male volunteers', 'Mean age of the participants was 22.11 (SD 2.1) years', 'healthy volunteers']","['ESOB containing phlai essential oils', 'ESOB containing phlai oil or olive oil', 'essential oil blend containing phlai oil', ' Essential oil blend (ESOB) containing Zingiber montanum or Phlai and Zingiber tenuiscapus oils', 'olive oil', 'ESOB containing phlai oil and olive oil']","['emotional stress', 'mood test scores', 'Mood status', 'Visual Analog Scales for Mood, Anxiety, Stress and Alertness (MASA', 'scores of negative mood', 'mood states', 'mood and stress']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0086209', 'cui_str': 'Emotional Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0622231', 'cui_str': 'MASA'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",38.0,0.156993,"However, no difference was observed regarding the mood test scores between groups, except concerning the Rorschach stress test (F (1,38)=6.486, p=0.015).","[{'ForeName': 'Warangkana', 'Initials': 'W', 'LastName': 'Arpornchayanon', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sumittra', 'Initials': 'S', 'LastName': 'Gomonchareonsiri', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Chansakaow', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Tinakon', 'Initials': 'T', 'LastName': 'Wongpakaran', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pairada', 'Initials': 'P', 'LastName': 'Varnado', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nahathai', 'Initials': 'N', 'LastName': 'Wongpakaran', 'Affiliation': 'Psychiatry, Chiang Mai University, 110 Intawaroros Rd., Chiang Mai 50200, Thailand.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0097'] 1339,31618127,"Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer.","PURPOSE Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM). PATIENTS AND METHODS A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading. RESULTS Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing. CONCLUSION GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712) has begun.",2019,"With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days).","['223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with', 'For Head and Neck Cancer', 'head and neck cancer']","['definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin', 'Radiotherapy and Cisplatin', 'GC4419, a superoxide dismutase mimetic, with placebo', 'GC4419 Versus Placebo', 'radiation therapy (RT', 'placebo', 'GC4419 or to receive placebo']","['SOM duration, incidence, and severity with acceptable safety', 'Safety', 'WHO grade of OM', 'efficacy and safety', 'duration, incidence, and severity of severe OM (SOM', 'SOM duration', 'Severe Oral Mucositis', 'GC4419-specific toxicity', 'SOM incidence', 'duration of SOM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",223.0,0.508431,"With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days).","[{'ForeName': 'Carryn M', 'Initials': 'CM', 'LastName': 'Anderson', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Cancer Care Northwest, Spokane, WA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Saunders', 'Affiliation': 'North East Cancer Centre, Health Sciences North, Northern Ontario School of Medicine, Sudbury, Ontario, Canada.'}, {'ForeName': 'Amarinthia', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'Spartanburg Medical Center, Spartanburg, SC.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Dunlap', 'Affiliation': 'University of Louisville/James Graham Brown Cancer Center, Louisville, KY.'}, {'ForeName': 'Chaitali', 'Initials': 'C', 'LastName': 'Nangia', 'Affiliation': 'University of California Irvine Medical Center, Orange, CA.'}, {'ForeName': 'Arielle S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'HOPE Cancer Center of East Texas, Tyler, TX.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Gordon', 'Affiliation': 'East Carolina University, Greenville, NC.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kovoor', 'Affiliation': 'Texas Oncology, Plano West, Plano, TX.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Arevalo-Araujo', 'Affiliation': 'Pasco Pinellas Cancer Center, Holiday, FL.'}, {'ForeName': 'Voichita', 'Initials': 'V', 'LastName': 'Bar-Ad', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Abhinand', 'Initials': 'A', 'LastName': 'Peddada', 'Affiliation': 'Renown Regional Medical Center, Reno, NV.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Colvett', 'Affiliation': 'Mountain States Health Alliance, Johnson City, TN.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Jersey Shore University Medical Center, Neptune, NJ.'}, {'ForeName': 'Anshu K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Ashland-Bellefonte Cancer Center, Ashland, KY.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wheeler', 'Affiliation': 'Goshen Center for Cancer Care, Goshen, IN.'}, {'ForeName': 'Dukagjin', 'Initials': 'D', 'LastName': 'Blakaj', 'Affiliation': 'James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Bonomi', 'Affiliation': 'James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Sanjiv S', 'Initials': 'SS', 'LastName': 'Agarwala', 'Affiliation': ""St Luke's Cancer Center and Temple University, Easton, PA.""}, {'ForeName': 'Madhur', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Worden', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Holmlund', 'Affiliation': 'Galera Therapeutics, Malvern, PA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Brill', 'Affiliation': 'Galera Therapeutics, Malvern, PA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Downs', 'Affiliation': 'Statistics Collaborative, Washington, DC.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Sonis', 'Affiliation': 'Primary Endpoint Solutions, Watertown, MA.'}, {'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Katz', 'Affiliation': 'Willis-Knighton Cancer Center, Shreveport, LA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Buatti', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01507'] 1340,31618382,A communication and information strategy in health and preparation for childbirth: a randomized cluster trial (PRENACEL).,"PRENACEL is a study that incorporates two innovative approaches to maternal and perinatal health: the need to improve women's level of satisfaction with the birthing experience and an assessment of the impacts of information and communication technologies in health. The approaches involve a communication program via short cellphone text messages, developed for Brazilian pregnant women in prenatal care in the Brazilian Unified National Health System. The analysis aims to determine whether the program contributes positively to women's perceived preparedness for childbirth. A randomized cluster trial was performed in 20 primary care units in Ribeirão Preto, São Paulo State, in 2015 and 2016. Data were collected for 1,210 women from interviews and patient charts. The data were submitted to two analytical models, per protocol and intention-to-treat. Women that had received information from the PRENACEL program during pregnancy were more likely to feel prepared for labor and delivery and to feel that prenatal care had helped them feel more prepared. There were also positive impacts on bonding with the newborn and breastfeeding in the delivery room and on knowledge of obstetric interventions. No differences were seen in the other maternal and perinatal outcomes, including women's satisfaction with the birthing care. PRENACEL can help expand women's access to strategic information for them to feel better prepared for the birthing experience.",2019,PRENACEL can help expand women's access to strategic information for them to feel better prepared for the birthing experience.,"['Brazilian pregnant women in prenatal care in the Brazilian Unified National Health System', '1,210 women from interviews and patient charts', '20 primary care units in Ribeirão Preto, São Paulo State, in 2015 and 2016', 'health and preparation for childbirth']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1268547', 'cui_str': 'Patient chart'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}]",[],[],1210.0,0.0540124,PRENACEL can help expand women's access to strategic information for them to feel better prepared for the birthing experience.,"[{'ForeName': 'Ana Carolina Arruda', 'Initials': 'ACA', 'LastName': 'Franzon', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Lívia', 'Initials': 'L', 'LastName': 'Oliveira-Ciabati', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Lívia Pimenta', 'Initials': 'LP', 'LastName': 'Bonifácio', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Elisabeth Meloni', 'Initials': 'EM', 'LastName': 'Vieira', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Magna Santos', 'Initials': 'MS', 'LastName': 'Andrade', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Jazmin Andrea Cifuentes', 'Initials': 'JAC', 'LastName': 'Sanchez', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Giordana Campos', 'Initials': 'GC', 'LastName': 'Braga', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Nogueira-Pileggi', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Fernandes', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Souza', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brasil.'}]",Cadernos de saude publica,['10.1590/0102-311X00111218'] 1341,31619131,The utility of cognitive changes in identifying those with acute graft vs. host disease following allogeneic hematopoietic cell transplant.,"Objectives: Acute graft versus host disease (aGVHD) is a common complication of allogeneic hematopoietic cell transplant (HCT) and is associated with morbidity and mortality. Identifying those at risk for developing aGVHD is crucial for early intervention. The current study assessed whether scores on a brief cognitive screening measure could identify those that develop aGVHD by 100 days post-HCT. Methods: Participants were 37 patients undergoing allogeneic HCT, assessed prior to transplant, and at 30- and 100-days post-HCT. Of those completing all evaluations, patients were divided into those who did ( n  = 14) and did not ( n  = 16) develop aGVHD by day 100 post-HCT. At 100 days post-transplant, groups did not differ on relevant demographic factors, disease, conditioning regimen, relatedness of donor, stem cell source, steroid use, total body irradiation use, human leukocyte antigens (HLA) match, or frequency of infection. Results: At 100 days post-HCT, those with aGVHD performed significantly worse on a working memory measure than those without aGvHD. The presence of aGVHD at day 100 increased significantly with every one standard deviation decrease in working memory from baseline to 30 days post-HCT (odds ratio = 3.08; 95% CI: 1.00-9.36). These findings were observed despite a small sample size and statistically controlling for multiple analyses. Conclusions: While this study is exploratory in nature, and has a small sample size, findings suggest that early detection of working memory declines could coincide with, or signal the development of, aGVHD. Potential etiologies are discussed. Implementing early cognitive screening within the first 30 days post-HCT may be useful in identifying patients at risk for aGVHD.",2020,"At 100 days post-HCT, those with aGVHD performed significantly worse on a working memory measure than those without aGvHD.","['Participants were 37 patients undergoing allogeneic HCT, assessed prior to transplant, and at 30- and 100-days post-HCT', 'allogeneic hematopoietic cell transplant']",['Acute graft versus host disease (aGVHD'],"['presence of aGVHD', 'relevant demographic factors, disease, conditioning regimen, relatedness of donor, stem cell source, steroid use, total body irradiation use, human leukocyte antigens (HLA) match, or frequency of infection', 'working memory', 'working memory measure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}]","[{'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",100.0,0.0274128,"At 100 days post-HCT, those with aGVHD performed significantly worse on a working memory measure than those without aGvHD.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Hoodin', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Attaphol', 'Initials': 'A', 'LastName': 'Pawarode', 'Affiliation': 'Department of Internal Medicine, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giordani', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Votruba', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1672791'] 1342,31619357,Macular Atrophy in Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial Comparing Ranibizumab and Aflibercept (RIVAL Study).,"PURPOSE To investigate differences in the development of macular atrophy (MA) over 24 months between treat-and-extend (T&E) ranibizumab and aflibercept in patients with neovascular age-related macular degeneration (nAMD). DESIGN A phase 4 randomized, partially masked, multicenter study. PARTICIPANTS Individuals 50 years of age or older diagnosed with active, treatment-naïve subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity (BCVA) of 23 logarithm of minimum angle of resolution letters or more. METHODS Patients were randomized 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2.0 mg and were treated according to the same reading center-guided T&E regimen after 3 initial monthly injections. MAIN OUTCOME MEASURES The primary outcome was mean change in square root area of MA from baseline to month 24. Key secondary outcomes included number of injections and mean change in BCVA from baseline to months 12 and 24. RESULTS Two hundred seventy-eight patients were included in the analysis (ranibizumab 0.5 mg, n = 141; aflibercept 2.0 mg, n = 137). Mean change in square root area of MA from baseline to month 24 was +0.36 mm (95% confidence interval [CI], 0.27-0.45 mm) for ranibizumab and +0.28 mm (95% CI, 0.19-0.37 mm) for aflibercept (treatment difference, +0.08 mm [95% CI, -0.05 to 0.21 mm]; P = 0.24). The proportion of patients with MA increased from 7% (10/141) to 37% (43/117) for ranibizumab and from 6% (8/137) to 32% (35/108) for aflibercept from baseline to month 24. The average number of injections received per year was similar between both groups: 9.6 (95% CI, 9.2-10.0) for ranibizumab and 9.5 (95% CI, 9.1-9.9) for aflibercept. The mean change in BCVA from baseline to month 24 was +6.6 letters (95% CI,4.7-8.5 letters) for the ranibizumab group and +4.6 letters (95% CI, 2.7-6.6 letters) for the aflibercept group ( P = 0.15). Rates of adverse events (AEs) were similar between both groups. CONCLUSIONS No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.",2020,No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.,"['patients with neovascular age-related macular degeneration (nAMD', 'Patients', 'Neovascular Age-Related Macular Degeneration', 'Two hundred seventy-eight patients were included in the analysis ', 'Individuals 50 years of age or older diagnosed with active, treatment-naïve subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity (BCVA) of 23 logarithm of minimum angle of resolution letters or more']","['ranibizumab', 'treat-and-extend (T&E) ranibizumab and aflibercept', 'Ranibizumab and Aflibercept', 'ranibizumab and aflibercept', 'intravitreal injections of ranibizumab 0.5 mg or aflibercept']","['mean change in square root area of MA', 'proportion of patients with MA', 'Mean change in square root area of MA', 'rate of development or growth of MA', 'average number of injections received per year', 'mean change in BCVA', 'number of injections and mean change in BCVA', 'Rates of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal (qualifier value)'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",278.0,0.510127,No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Gillies', 'Affiliation': 'Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia. Electronic address: mark.gillies@sydney.edu.au.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Hunyor', 'Affiliation': 'Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia; Retina Associates, Chatswood, Australia.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Arnold', 'Affiliation': 'Marsden Eye Specialists, Parramatta, Australia.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital and Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Francois L', 'Initials': 'FL', 'LastName': 'Pecheur', 'Affiliation': 'Healthcare Professionals Group Pty Ltd, Sydney, Australia.'}, {'ForeName': 'Marion R', 'Initials': 'MR', 'LastName': 'Munk', 'Affiliation': 'Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'McAllister', 'Affiliation': 'Center for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia.'}]",Ophthalmology,['10.1016/j.ophtha.2019.08.023'] 1343,31862277,The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial.,"BACKGROUND AND OBJECTIVES Burn patients experience a high level of anxiety and poor sleep quality due to their special physical and psychological conditions. The present study aimed to investigate the effect of progressive muscle relaxation on anxiety and sleep quality in burn patients. METHODOLOGY AND PARTICIPANTS In this randomized controlled clinical trial, a total of 80 patients admitted to burn ward were enrolled using convenient sampling and randomly assigned to one of the experimental or control groups. In the experimental group, patients were intervened using Jacobson's relaxation technique 20-30min daily for three consecutive days. During this period, the control group received only routine care and treatment. Patients' anxiety and their sleep quality were measured and recorded before and after the intervention using the Spielberger State-Trait Anxiety Inventory (STAI) and St Mary's Hospital Sleep Quality Questionnaire (SMHSQ) respectively. Eventually, data analysis was conducted using SPSS version 20.0 software (IBM Corp., Armonk, N.Y., USA). RESULTS The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05). CONCLUSION Relaxation as a complementary method can be used along with modern medicine to reduce anxiety and improve sleep quality in burn patients.",2020,"The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05). ","['80 patients admitted to burn ward', 'burn patients', 'Burn patients experience a high level of anxiety and poor sleep quality due to their special physical and psychological conditions']",['progressive muscle relaxation'],"['sleep quality', ""Spielberger State-Trait Anxiety Inventory (STAI) and St Mary's Hospital Sleep Quality Questionnaire (SMHSQ"", ""Patients' anxiety and their sleep quality"", 'anxiety', 'anxiety and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",80.0,0.0416758,"The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05). ","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Faculty of Nursing, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. Electronic address: m.harorani@yahoo.com.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Faculty of Nursing, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Masmouei', 'Affiliation': 'Faculty of Nursing, Department of Nursing, School of Nursing Hazrat Zahra(P.B.U.H) Abadeh, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.11.021'] 1344,31628482,"A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis.","OBJECTIVES 3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease activity. METHODS We conducted a randomized double-blind placebo-controlled 12 week trial of lovastatin vs placebo in 64 RA patients with mild clinical disease activity but an elevated CRP. The primary efficacy end point was the reduction in mean log CRP. Secondary end points included disease activity, RF and anti-CCP antibody titres. Mechanistic end points included levels of serum cytokines. Safety was assessed; hepatic and muscle toxicities were of particular interest. RESULTS Baseline features were similar between groups. No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group. Mechanistic analyses did not reveal significant changes in any biomarkers. A post hoc analysis of subjects not using biologic therapy demonstrated a significantly greater proportion achieving ⩾20% reduction in CRP from baseline in the lovastatin group compared with placebo (P-value = 0.007). No difference was observed in subjects receiving biologics. Lovastatin was well tolerated with no serious safety concerns. CONCLUSION This study showed no anti-inflammatory or clinical effects on RA disease activity after 12 weeks of treatment with lovastatin. Lovastatin had a modest effect on CRP in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients. TRIAL REGISTRATION ClinicalTrials.gov, http://clinicaltrials.gov, NCT00302952.",2020,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","['mildly active rheumatoid arthritis', 'hyperlipidaemia', 'patients with RA with', '64 RA patients with mild clinical disease activity but an elevated CRP']","['lovastatin', '3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins', 'lovastatin therapy', 'placebo', 'lovastatin vs placebo', 'Lovastatin']","['mean log CRP', 'CRP', 'hepatic and muscle toxicities', 'mean log CRP reduction', 'disease activity, RF and anti-CCP antibody titres', 'RA disease activity', 'disease activity', 'levels of serum cytokines']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4318437', 'cui_str': 'Anti-CCP'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.344131,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cush', 'Affiliation': 'Division of Rheumatology, Baylor University Medical Center, Dallas, USA.'}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': 'Division of Rheumatology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Striebich', 'Affiliation': 'Division of Rheumatology, University of Colorado, Denver, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""Dall'era"", 'Affiliation': 'Division of Rheumatology, University of California, San Francisco, USA.'}, {'ForeName': 'Meggan', 'Initials': 'M', 'LastName': 'Mackay', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Olech', 'Affiliation': 'Department of Internal Medicine, University of Nevada School of Medicine, Las Vegas, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Internal Medicine, University of Utah, Internal Medicine, Salt Lake City, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Box', 'Affiliation': 'Box Arthritis & Rheumatology of the Carolinas, Charlotte, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keating', 'Affiliation': 'Division of Rheumatology, Scripps Green Hospital, La Jolla, USA.'}, {'ForeName': 'Mary Chester', 'Initials': 'MC', 'LastName': 'Wasko', 'Affiliation': 'Division of Rheumatology, Western Pennsylvania Hospital, Pittsburgh, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'St Clair', 'Affiliation': 'Division of Rheumatology and Immunology, Duke University School of Medicine, Durham, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Weiquang', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'PetaGay', 'Initials': 'P', 'LastName': 'Ricketts', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Welch', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Spychala', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'York', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez471'] 1345,29217376,"Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials.","BACKGROUND The Zika virus epidemic and associated congenital infections have prompted rapid vaccine development. We assessed two new DNA vaccines expressing premembrane and envelope Zika virus structural proteins. METHODS We did two phase 1, randomised, open-label trials involving healthy adult volunteers. The VRC 319 trial, done in three centres, assessed plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera), and the VRC 320, done in one centre, assessed plasmid VRC5283 (wild-type Zika virus). Eligible participants were aged 18-35 years in VRC19 and 18-50 years in VRC 320. Participants were randomly assigned 1:1 by a computer-generated randomisation schedule prepared by the study statistician. All participants received intramuscular injection of 4 mg vaccine. In VRC 319 participants were assigned to receive vaccinations via needle and syringe at 0 and 8 weeks, 0 and 12 weeks, 0, 4, and 8 weeks, or 0, 4, and 20 weeks. In VRC 320 participants were assigned to receive vaccinations at 0, 4, and 8 weeks via single-dose needle and syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA) in each deltoid. Both trials followed up volunteers for 24 months for the primary endpoint of safety, assessed as local and systemic reactogenicity in the 7 days after each vaccination and all adverse events in the 28 days after each vaccination. The secondary endpoint in both trials was immunogenicity 4 weeks after last vaccination. These trials are registered with ClinicalTrials.gov, numbers NCT02840487 and NCT02996461. FINDINGS VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group). One participant in VRC 319 and two in VRC 320 withdrew after one dose of vaccine, but were included in the safety analyses. Both vaccines were safe and well tolerated. All local and systemic symptoms were mild to moderate. In both studies, pain and tenderness at the injection site was the most frequent local symptoms (37 [46%] of 80 participants in VRC 319 and 36 [80%] of 45 in VRC 320) and malaise and headache were the most frequent systemic symptoms (22 [27%] and 18 [22%], respectively, in VRC 319 and 17 [38%] and 15 [33%], respectively, in VRC 320). For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. INTERPRETATION VRC5283 was well tolerated and has advanced to phase 2 efficacy testing. FUNDING Intramural Research Program of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health.",2018,"For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. ","['VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group', 'In VRC 320 participants', 'Eligible participants were aged 18-35 years in VRC19 and 18-50 years in VRC 320', 'In VRC 319 participants', 'healthy adult volunteers', 'healthy adults']","['syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA', 'Zika virus DNA vaccine candidates', 'intramuscular injection of 4 mg vaccine', 'vaccinations via needle and syringe']","['safe and well tolerated', 'geometric mean titre', 'malaise and headache', 'adverse events', 'local symptoms', 'pain and tenderness', 'plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera', 'local and systemic reactogenicity', 'systemic symptoms', 'Safety, tolerability, and immunogenicity']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0234242', 'cui_str': 'Pain and tenderness (finding)'}, {'cui': 'C0032136', 'cui_str': 'Plasmids'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0014047', 'cui_str': 'Japanese encephalitis virus'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",320.0,0.194294,"For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. ","[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Houser', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kaitlyn M', 'Initials': 'KM', 'LastName': 'Morabito', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Yamshchikov', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ro Shauna', 'Initials': 'RS', 'LastName': 'Rothwell', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Floreliz', 'Initials': 'F', 'LastName': 'Mendoza', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jamie G', 'Initials': 'JG', 'LastName': 'Saunders', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Novik', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Hendel', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Josephine H', 'Initials': 'JH', 'LastName': 'Cox', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Hope Clinic of the Emory Vaccine Center, Emory School of Medicine, Decatur, GA, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'McArthur', 'Affiliation': 'University of Maryland Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Hope Clinic of the Emory Vaccine Center, Emory School of Medicine, Decatur, GA, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'University of Maryland Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ginny E', 'Initials': 'GE', 'LastName': 'Cummings', 'Affiliation': 'University of Maryland Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sitar', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bryant M', 'Initials': 'BM', 'LastName': 'Foreman', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Burgomaster', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Pelc', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Gordon', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'DeMaso', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Dowd', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Laurencot', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Schwartz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Pierson', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: grace.chen@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(17)33105-7'] 1346,29912070,The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study.,"OBJECTIVES The purpose of this pilot study was three-fold: 1) to evaluate the safety and feasibility of instituting massage therapy in the immediate postoperative period after congenital heart surgery, 2) to examine the preliminary results on effects of massage therapy versus standard of care plus three reading visits on postoperative pain and anxiety, and 3) to evaluate preliminary effects of opioid and benzodiazepine exposure in patients receiving massage therapy compared with reading controls. DESIGN Prospective, randomized controlled trial. SETTING An academic children's hospital. SUBJECTS Sixty pediatric heart surgery patients between ages 6 and 18 years. INTERVENTIONS Massage therapy and reading. MEASUREMENT AND MAIN RESULTS There were no adverse events related to massage or reading interventions in either group. Our investigation found no statistically significant difference in Pain or State-Trait Anxiety scores in the initial 24 hours after heart surgery (T1) and within 48 hours of transfer to the acute care unit (T2) after controlling for age, gender, and Risk Adjustment for Congenital Heart Surgery 1 score. However, children receiving massage therapy had significantly lower State-Trait Anxiety scores after receiving massage therapy at time of discharge (T3; p = 0.0075) than children receiving standard of care plus three reading visits. We found no difference in total opioid exposure during the first 3 postoperative days between groups (median [interquartile range], 0.80 mg/kg morphine equivalents [0.29-10.60] vs 1.13 mg/kg morphine equivalents [0.72-6.14]). In contrast, children receiving massage therapy had significantly lower total benzodiazepine exposure in the immediate 3 days following heart surgery (median [interquartile range], 0.002 mg/kg lorazepam equivalents [0-0.03] vs 0.03 mg/kg lorazepam equivalents [0.02-0.09], p = 0.0253, Wilcoxon rank-sum) and number of benzodiazepine PRN doses (0.5 [0-2.5] PRN vs 2 PRNs (1-4); p = 0.00346, Wilcoxon rank-sum). CONCLUSIONS Our pilot study demonstrated the safety and feasibility of implementing massage therapy in the immediate postoperative period in pediatric heart surgery patients. We found decreased State-Trait Anxiety scores at discharge and lower total exposure to benzodiazepines. Preventing postoperative complications such as delirium through nonpharmacologic interventions warrants further evaluation.",2018,"Our investigation found no statistically significant difference in Pain or State-Trait Anxiety scores in the initial 24 hours after heart surgery (T1) and within 48 hours of transfer to the acute care unit (T2) after controlling for age, gender, and Risk Adjustment for Congenital Heart Surgery 1 score.","['Sixty pediatric heart surgery patients between ages 6 and 18 years', 'patients receiving massage therapy compared with reading controls', ""An academic children's hospital"", 'pediatric heart surgery patients']","['massage therapy', 'Massage and Reading', 'Massage therapy and reading', 'opioid and benzodiazepine', 'massage therapy versus standard of care plus three reading visits', 'implementing massage therapy', 'instituting massage therapy']","[""Children's Pain and Anxiety"", 'safety and feasibility', 'State-Trait Anxiety scores', 'Pain or State-Trait Anxiety scores', 'number of benzodiazepine PRN doses', 'total opioid exposure', 'total benzodiazepine exposure']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3536731', 'cui_str': 'Massage Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C3536731', 'cui_str': 'Massage Therapy'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0558288', 'cui_str': 'prn'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",60.0,0.0837471,"Our investigation found no statistically significant difference in Pain or State-Trait Anxiety scores in the initial 24 hours after heart surgery (T1) and within 48 hours of transfer to the acute care unit (T2) after controlling for age, gender, and Risk Adjustment for Congenital Heart Surgery 1 score.","[{'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Staveski', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Research in Patient Services, Cincinnati, OH.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Boulanger', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Massage Therapy Service, Palo Alto, CA.""}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Erman', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Massage Therapy Service, Palo Alto, CA.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Research in Patient Services, Cincinnati, OH.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Almgren', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Patient Services - Advanced Practice Nursing, Palo Alto, CA.""}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Journel', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Patient Services - Advanced Practice Nursing, Palo Alto, CA.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Roth', 'Affiliation': ""Department of Cardiology and Critical Care, Lucile Packard Children's Hospital Stanford, Palo Alto, CA.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Golianu', 'Affiliation': 'Department of Pediatrics, Stanford University, School of Medicine, Palo Alto, CA.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001615'] 1347,31861049,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effectiveness of a Food Supplement Containing Creatine and D-Ribose Combined with a Physical Exercise Program in Increasing Stress Tolerance in Patients with Ischemic Heart Disease.","The aim of this study is to establish whether a supplement of creatine and ribose combined with a physical exercise program can improve the total work capacity during exercise in a population of patients with known ischemic heart disease. A double-blind, six-month study was designed in which 53 patients were enrolled and randomized to take either a nutraceutical composition containing creatine, D-ribose, vitamin B 1 , and vitamin B 6 (active treatment) or the placebo. Both the nutraceutical supplement and the placebo were supplied by Giellepi S.p.A. Health Science in Lissone, Italy. After six months of study, the cardiac double product at the peak of the load, the delta double product, and the chronotropic index were higher in the active treatment group than in the placebo group. We can conclude that a supplementation with creatine, D-ribose, vitamin B 1 , and vitamin B 6 , in addition to standard therapy and a physical exercise program, seems to be helpful in improving exercise tolerance compared to the placebo in a population with cardiovascular disease. However, this needs to be further studied, given that there is no clear evidence that the double product can be used as a surrogate measure of exercise tolerance.",2019,"After six months of study, the cardiac double product at the peak of the load, the delta double product, and the chronotropic index were higher in the active treatment group than in the placebo group.","['Patients with Ischemic Heart Disease', '53 patients', 'patients with known ischemic heart disease']","['Placebo', 'nutraceutical composition containing creatine, D-ribose, vitamin B 1 , and vitamin B 6 (active treatment) or the placebo', 'creatine and ribose combined with a physical exercise program', 'Ribose Combined with a Physical Exercise Program', 'placebo', 'supplementation with creatine, D-ribose, vitamin B 1 , and vitamin B 6 , in addition to standard therapy and a physical exercise program', 'Food Supplement Containing Creatine and D']","['Stress Tolerance', 'exercise tolerance', 'total work capacity', 'chronotropic index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0035549', 'cui_str': 'Ribose'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0520943', 'cui_str': 'Stress tolerance'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",53.0,0.54215,"After six months of study, the cardiac double product at the peak of the load, the delta double product, and the chronotropic index were higher in the active treatment group than in the placebo group.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pasqualotto', 'Affiliation': 'Section of Cardiology, Department of Medicine, University of Verona, 37017 Verona, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Catena', 'Affiliation': 'Cardiologic Unit, ASL of Teramo, 64100 Teramo, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Maggi', 'Affiliation': 'Cardiologic Unit, Poliambulanza Foundation, 25020 Brescia, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.'}]",Nutrients,['10.3390/nu11123075'] 1348,31862174,Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial.,"INTRODUCTION The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown. AIM To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension. METHODS We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg). MAIN OUTCOME MEASURE The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years. RESULTS At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = -1.17; 95% CI = -1.92, -0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity. CLINICAL IMPLICATIONS The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude. STRENGTH & LIMITATIONS Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed. CONCLUSION In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238-248.",2020,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","['men with hypertension, but without diabetes', 'men with hypertension', '1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk', 'Hypertensive Men']","['Intensive vs Standard Blood Pressure Treatment', 'intensive blood pressure control', 'intensive systolic blood pressure (SBP) lowering', 'intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg']","['erectile function', 'erectile function, testosterone, other androgen, and estrogen levels', '5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21', 'change in erectile function', 'incidence of ED', 'intensive blood pressure lowering', 'IIEF-5 score', 'cardiovascular events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1255.0,0.183276,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","[{'ForeName': 'Capri G', 'Initials': 'CG', 'LastName': 'Foy', 'Affiliation': 'Division of Public Health Sciences, Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: cfoy@wakehealth.edu.'}, {'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Newman', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Greg B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford VA Hospital, Bedford, MA, and Boston University School of Medicine and Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': ""Michael E. DeBakey Veterans' Administration Medical Center, Houston, TX, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Burgner', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Thaddeus Y', 'Initials': 'TY', 'LastName': 'Carson', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Doumas', 'Affiliation': 'Second Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Robin Y', 'Initials': 'RY', 'LastName': 'Hughes', 'Affiliation': 'University Hospitals Case Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Robert Wood Johnson Medical School, Rutgers University, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Peter van', 'Initials': 'PV', 'LastName': 'Buren', 'Affiliation': ""Department of Internal Medicine, Dallas Veterans' Administration Medical Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.11.256'] 1349,31626067,"Does It Work for Everyone? The Effect of the Take a Stand! Sitting-Intervention in Subgroups Defined by Socio-Demographic, Health-Related, Work-Related, and Psychosocial Factors.","OBJECTIVE Take a Stand! was a multicomponent workplace-based intervention reducing sitting among office-workers. This study tested whether the effect of Take a Stand! differed across subgroups. METHODS A cluster-randomized controlled trial with objectively measured sitting-time as primary outcome evaluated Take a Stand! Main analysis was reanalyzed in strata defined by four levels of preselected factors: socio-demographic (eg, sex); health-related (eg, smoking); work-related (eg, workhours); and psychosocial (eg, motivation to change sitting). RESULTS No notable differences in the effect were observed: across all assessed subgroups sitting time was ∼60 minutes less after 1 month and ∼40 minutes less after 3 months in intervention as compared with control group. CONCLUSION There was no differential effect of Take a Stand! indicating that the intervention was effective in all groups. This knowledge is advantageous when disseminating similar interventions to different populations of office workers.",2020,"No notable differences in the effect was observed: across all assessed subgroups sitting time was ∼60 min less after 1 month and ∼40 min after 3 months in intervention as compared to control group. ",[],['Sitting-Intervention'],['subgroups sitting time'],[],"[{'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0921429,"No notable differences in the effect was observed: across all assessed subgroups sitting time was ∼60 min less after 1 month and ∼40 min after 3 months in intervention as compared to control group. ","[{'ForeName': 'Ida H', 'Initials': 'IH', 'LastName': 'Danquah', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Janne S', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001737'] 1350,31628486,An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs.,"OBJECTIVES The objective of this trial was to compare effectiveness of certolizumab pegol added to conventional synthetic DMARDs (csDMARDs) in RA patients, followed by continuing vs discontinuing background csDMARDs after treatment response. METHODS Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible. At 3 or 6 months, patients who achieved a change (Δ) in DAS28 of ⩾1.2 were randomized to continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO) (unblinded). The primary outcome was non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity at 18 months (non-inferiority margin: 15 percentile units). RESULTS A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45). No significant differences were observed between groups in baseline age, gender, race, RF status or prior biologics (16% vs 11%). Although the rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement at 18 months was clinically comparable between the two groups (72% vs 69%), non-inferiority assumptions were not met [absolute risk difference (upper limit of 90% CI): 2.6% (19.1%)]. Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28 ⩾ 1.2, and 41% each remission. CONCLUSION Among RA patients achieving a therapeutic response on combination therapy with certolizumab pegol and csDMARDs, withdrawing csDMARDs was not non-inferior to maintaining csDMARDs but improvements were sustained in both groups at 18 months.",2020,"Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28","['RA patients', 'Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible', 'A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45']","['certolizumab pegol added to conventional synthetic DMARDs (csDMARDs', 'certolizumab pegol combined with DMARDs', 'ΔDAS28', 'continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO']","['RF status or prior biologics', 'rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement', 'non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity', 'DAS28 low disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",88.0,0.172243,"Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'Department of Medicine, University of Western Ontario, ON.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Rampakakis', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Vaillancourt', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Department of Medicine, Laval University, Québec, QC.'}, {'ForeName': 'Juris', 'Initials': 'J', 'LastName': 'Lazovskis', 'Affiliation': 'Department of Medicine, Dalhousie University, Saint John, NB.'}, {'ForeName': 'Boulos', 'Initials': 'B', 'LastName': 'Haraoui', 'Affiliation': 'Institut de Rhumatologie de Montréal, Montréal, QC.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sampalis', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez470'] 1351,31526767,Dopamine replacement improves motor learning of an upper extremity task in people with Parkinson disease.,"BACKGROUND Dopamine replacement medication has positive effects on existing motor skills for people with Parkinson disease (PD), but may have detrimental effects on the learning of motor skills necessary for effective rehabilitation according to the dopamine overdose hypothesis. OBJECTIVES This study aimed to determine whether dopamine replacement medication (i.e. levodopa) affects: learning of a novel upper extremity task, decrements in skill following withdrawal of practice, the rate of learning, and the transfer of movement skill to untrained upper extremity tasks compared to training ""off"" medication, in people with PD. METHODS Participants with mild-moderate PD (Hoehn and Yahr stage 2) were randomized to train ""on"" (n = 12) or ""off"" (n = 11) levodopa medication. Participants practiced 10 blocks of five trials of a functional motor task with their non-dominant upper extremity over three consecutive days (acquisition period), followed by a single block of five trials two and nine days later. Participants were also assessed ""on"" levodopa with two transfer tasks (the nine-hole peg test and a functional dexterity task) prior to any practice and nine days after the end of the acquisition period. RESULTS Participants who practiced ""on"" levodopa medication learned the upper extremity task to a greater extent that those who practiced ""off"" medication, as determined by retained performance two days after practice. Skill decrement and skill transfer were not significantly different between groups. Rate of learning was unable to be modelled in this sample. CONCLUSIONS Levodopa medication improved the learning of an upper extremity task in people with mild-moderate PD.",2020,Skill decrement and skill transfer were not significantly different between groups.,"['people with mild-moderate PD', 'Participants who practiced ""on"" levodopa medication learned the', 'Participants with mild-moderate PD (Hoehn and Yahr stage 2', 'people with Parkinson disease', 'people with Parkinson disease (PD']","['Dopamine replacement', 'dopamine replacement medication (i.e. levodopa', 'Levodopa medication', 'Dopamine replacement medication', 'train ""on"" (n\u202f=\u202f12) or ""off"" (n\u202f=\u202f11) levodopa medication', 'functional motor task with their non-dominant upper extremity']","['Skill decrement and skill transfer', 'upper extremity task', 'learning of an upper extremity task', 'Rate of learning', 'motor learning of an upper extremity task']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",10.0,0.136439,Skill decrement and skill transfer were not significantly different between groups.,"[{'ForeName': 'Serene S', 'Initials': 'SS', 'LastName': 'Paul', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA; Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, 75 East St, Lidcombe, NSW, 2141, Australia. Electronic address: serene.paul@sydney.edu.au.'}, {'ForeName': 'Leland E', 'Initials': 'LE', 'LastName': 'Dibble', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Genevieve N', 'Initials': 'GN', 'LastName': 'Olivier', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA; Department of Physical Therapy, University of Arkansas for Medical Sciences, 1125 N College Ave, Fayetteville, AR, 72703, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Duff', 'Affiliation': ""Center for Alzheimer's Care, Imaging & Research, Department of Neurology, University of Utah, 650 Komas Dr 106A, Salt Lake City, UT, 84108, USA.""}, {'ForeName': 'Sydney Y', 'Initials': 'SY', 'LastName': 'Schaefer', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA; Department of Biological and Health Systems Engineering, Arizona State University, 501 E Tyler Mall, MC 9709, Tempe, AZ, 85287, USA.'}]",Behavioural brain research,['10.1016/j.bbr.2019.112213'] 1352,31597624,"Efficacy of early controlled motion of the ankle compared with immobilisation in non-operative treatment of patients with an acute Achilles tendon rupture: an assessor-blinded, randomised controlled trial.","BACKGROUND Early controlled motion (ECM) of the ankle is widely used in the non-operative treatment of acute Achilles tendon rupture, although its safety and efficacy have not been investigated properly in a randomised set-up. PURPOSE/AIM OF THE STUDY To investigate if ECM of the ankle was superior to immobilisation in the treatment of acute Achilles tendon rupture. MATERIALS AND METHODS This was an assessor-blinded, randomised controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18-70 years were eligible for inclusion. The ECM group performed movements of the ankle five times a day from week 3 to week 8 after rupture. The control group was immobilised for 8 weeks. The primary outcome was the Achilles tendon Total Rupture Score (ATRS) evaluated at 1-year postinjury. The secondary outcomes were heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture. Analysis was conducted as intention-to-treat using inverse probability weighting. FINDINGS/RESULTS 189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016. There were 64 patients in the ECM group and 58 in the immobilisation group. There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively. HRW was 60% (21) and 60% (21) of the uninjured limb, and elongation was 18 mm (13) and 16 mm (11), respectively. Correspondingly, there were six and seven reruptures. CONCLUSIONS ECM revealed no benefit compared with immobilisation in any of the investigated outcomes. TRIAL REGISTRATION NUMBER NCT02015364.",2020,"There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively.","['Patients aged 18-70 years were eligible for inclusion', 'acute Achilles tendon rupture', '64 patients in the ECM group and 58 in the immobilisation group', '189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016', 'patients with an acute Achilles tendon rupture']","['ECM', 'immobilisation']","['heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture', 'HRW', 'Achilles tendon Total Rupture Score (ATRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",189.0,0.402862,"There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively.","[{'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Department of Orthopeadic Surgery, Copenhagen University Hospital Hvidovre, Sports Orthopeadic Research Center - Copenhagen (SORC-C), Copenhagen, Denmark kbarfod@dadlnet.dk.'}, {'ForeName': 'Maria Swennergren', 'Initials': 'MS', 'LastName': 'Hansen', 'Affiliation': 'Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hölmich', 'Affiliation': 'Department of Orthopeadic Surgery, Copenhagen University Hospital Hvidovre, Sports Orthopeadic Research Center - Copenhagen (SORC-C), Copenhagen, Denmark.'}, {'ForeName': 'Morten Tange', 'Initials': 'MT', 'LastName': 'Kristensen', 'Affiliation': 'Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopaedic Surgery, Clinical Orthopaedic Research Hvidovre, Copenhagen University Hospital, Copenhagen, Denmark.'}]",British journal of sports medicine,['10.1136/bjsports-2019-100709'] 1353,29188882,Nutrient Intake During Diet-Induced Weight Loss and Exercise Interventions in a Randomized Trial in Older Overweight and Obese Adults.,"OBJECTIVES Dietary restriction in obese older adults undergoing weight loss may exacerbate nutrient deficiencies common in this group; the nutritional health of older adults is a factor in their quality of life, disability, and mortality. This study examined the effect of an 18-month weight loss program based in social cognitive theory incorporating partial meal replacements, on nutrient intake in older overweight and obese adults. DESIGN The following analysis is from the Intensive Diet and Exercise for Arthritis (IDEA) trial, a single-blind, randomized controlled trial. Individuals were randomized into one of three 18-month interventions: exercise (E); intensive diet-induced weight loss (D); or intensive diet-induced weight loss plus exercise (D+E). SETTING The study setting was at a university research facility. PARTICIPANTS Overweight and obese older adults (n=388; BMI=33.7±3.8 kg/m2; 65.8±6.1 years) were recruited. INTERVENTIONS The D and D+E interventions (group mean goal of ≥10% loss by 18-months) utilized partial meal replacements (2 meal replacement shakes/day for 6-months). Exercise training for E and D+E was 3 days/week, 60 minutes/day. MEASUREMENTS Three day food records were collected at baseline, 6-months, and 18-months and analyzed for total energy and macro- and micronutrient intake. Comparisons of dietary intake among treatment groups were performed at 6 and 18 months using mixed linear models. RESULTS Weight loss at 18-months was 11.3±8.3% (D), 10.3±6.8% (D+E), and 1.2±4.2% (E). Meal replacements were used by more than 60% (6-months) and 50% (18-months) of D and D+E participants, compared to ≤15% for E. Both D and D+E consumed less energy and fat, and more carbohydrates and selected micronutrients than E during follow-up. More than 50% of all participants consumed less than the recommended intake of particular vitamins and minerals. CONCLUSIONS The diet intervention improved intakes of several nutrients. However, inadequate intake of several vitamins and minerals of concern for older adults suggests they need further guidance to assure adequate intake.",2017,"Meal replacements were used by more than 60% (6-months) and 50% (18-months) of D and D+E participants, compared to ≤15% for E.","['Older Overweight and Obese Adults', 'obese older adults undergoing weight loss', 'Overweight and obese older adults (n=388; BMI=33.7±3.8 kg/m2; 65.8±6.1 years) were recruited', 'older adults', 'older overweight and obese adults', 'The study setting was at a university research facility']","['weight loss program based in social cognitive theory incorporating partial meal replacements', 'exercise (E); intensive diet-induced weight loss (D); or intensive diet-induced weight loss plus exercise (D+E', 'Diet-Induced Weight Loss and Exercise Interventions', 'Exercise training']","['Nutrient Intake', 'total energy and macro- and micronutrient intake', 'intakes of several nutrients', 'Weight loss']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0341311,"Meal replacements were used by more than 60% (6-months) and 50% (18-months) of D and D+E participants, compared to ≤15% for E.","[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Gary D. Miller, PhD, Box 7868 Reynolda Station, Department Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109-7868, millergd@wfu.edu; 336-758-1901; 336-758-4680 (fax).'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hamm', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Mihalko', 'Affiliation': ''}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-017-0892-5'] 1354,31487231,Comparative Effects of High-Tech Visual Scene Displays and Low-Tech Isolated Picture Symbols on Engagement From Students With Multiple Disabilities.,"Purpose Augmentative and alternative communication (AAC) is an intervention approach that can promote communication and language in children with multiple disabilities who are beginning communicators. While a wide range of AAC technologies are available, little is known about the comparative effects of specific technology options. Given that engagement can be low for beginning communicators with multiple disabilities, the current study provides initial information about the comparative effects of 2 AAC technology options-high-tech visual scene displays (VSDs) and low-tech isolated picture symbols-on engagement. Method Three elementary-age beginning communicators with multiple disabilities participated. The study used a single-subject, alternating treatment design with each technology serving as a condition. Participants interacted with their school speech-language pathologists using each of the 2 technologies across 5 sessions in a block randomized order. Results According to visual analysis and nonoverlap of all pairs calculations, all 3 participants demonstrated more engagement with the high-tech VSDs than the low-tech isolated picture symbols as measured by their seconds of gaze toward each technology option. Despite the difference in engagement observed, there was no clear difference across the 2 conditions in engagement toward the communication partner or use of the AAC. Conclusions Clinicians can consider measuring engagement when evaluating AAC technology options for children with multiple disabilities and should consider evaluating high-tech VSDs as 1 technology option for them. Future research must explore the extent to which differences in engagement to particular AAC technologies result in differences in communication and language learning over time as might be expected.",2019,"Despite the difference in engagement observed, there was no clear difference across the 2 conditions in engagement toward the communication partner or use of the AAC.","['Method Three elementary-age beginning communicators with multiple disabilities participated', 'Participants interacted with their school speech-language pathologists', 'children with multiple disabilities who are beginning communicators', 'children with multiple disabilities', 'Students With Multiple Disabilities']","['Augmentative and alternative communication (AAC', 'High-Tech Visual Scene Displays and Low-Tech Isolated Picture Symbols']",[],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0935560', 'cui_str': 'Multiple disability'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}]",[],,0.0210846,"Despite the difference in engagement observed, there was no clear difference across the 2 conditions in engagement toward the communication partner or use of the AAC.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Holyfield', 'Affiliation': 'Department of Rehabilitation, Human Resources, and Communication Disorders, University of Arkansas, Fayetteville.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Department of Speech-Language Pathology, Fort Smith Public Schools, Arkansas.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Schluterman', 'Affiliation': 'Department of Speech-Language Pathology, Fort Smith Public Schools, Arkansas.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-19-0007'] 1355,31605983,"Do sociodemographic features, pain sensitivity or pain catastrophizing relate to clinic-based adherence to physiotherapy in people suffering from chronic spinal pain? Secondary analysis of a randomized clinical trial.","PURPOSE Examining whether socio-demographic variables, pain or functionality are related to the degree of clinic-based therapy adherence in patients suffering from nonspecific chronic spinal pain (nCSP). DESIGN Secondary analysis of a randomized clinical trial. SETTING University hospital of Ghent and Brussels. METHODS Dutch speakers, 18-65 years old, experiencing nCSP for at least 3 months. 120 participants were randomly allocated to two interventional groups, of which 94 completed all therapy sessions. MAIN OUTCOME MEASURES Degree of clinic-based adherence, defined as the amount of completed therapy sessions. RESULTS Demographic data (sex, age or education) were not significantly associated with adherence in the total sample or the neuroscience group. For the traditional physiotherapy group, educational level was associated with attendance of at least 50% of the therapy sessions. Regarding pain-, belief- and function-related measures, only the association between change in kinesiophobia and adherence was significant for the traditional physiotherapy group. CONCLUSIONS Factors related to therapy adherence in the total group or the neuroscience group could not be found. Educational level and change in kinesiophobia were however related to therapy adherence in the traditional physiotherapy group.",2019,"RESULTS Demographic data (sex, age or education) were not significantly associated with adherence in the total sample or the neuroscience group.","['University hospital of Ghent and Brussels', 'patients suffering from nonspecific chronic spinal pain (nCSP', 'Dutch speakers, 18-65 years old, experiencing nCSP for at least 3 months', '120 participants']",[],"['Educational level and change in kinesiophobia', 'educational level', 'Degree of clinic-based adherence, defined as the amount of completed therapy sessions']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine (finding)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",120.0,0.0791258,"RESULTS Demographic data (sex, age or education) were not significantly associated with adherence in the total sample or the neuroscience group.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lenoir', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, Building F, 1090, Brussel, Belgium. Electronic address: dorine.lenoir@ugent.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Coppieters', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, Building F, 1090, Brussel, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Laarbeeklaan 101, 1090, Brussel, Belgium.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Willaert', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, Building F, 1090, Brussel, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kregel', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, Building F, 1090, Brussel, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Danneels', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cagnie', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Meeus', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Rehabilitation Sciences and Physiotherapy (MOVANT), Faculty of Medicine and Health Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, 2610, Wilrijk, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, Building F, 1090, Brussel, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Laarbeeklaan 101, 1090, Brussel, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malfliet', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Building B3, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, Building F, 1090, Brussel, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Laarbeeklaan 101, 1090, Brussel, Belgium; Research Foundation, Flanders (FWO), Brussels, Belgium.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2019.102066'] 1356,31600474,The Impact of Dose and Dose Frequency on Word Learning by Kindergarten Children With Developmental Language Disorder During Interactive Book Reading.,"Purpose The goal was to determine whether interactive book reading outcomes for children with developmental language disorder (DLD) were affected by manipulation of dose (i.e., the number of exposures to the target word during a book reading session) and dose frequency (i.e., the number of repeated book reading sessions) and whether pretreatment factors predicted treatment response variation. Method Thirty-four kindergarten children with DLD (aged 5;0-6;2 [years;months]) were taught 1 set of words using the Dose 6 and Dose Frequency 6 format from a prior study (Storkel, Voelmle, et al., 2017) and taught a different set of words using an alternative format, either Dose 4 × Dose Frequency 9 or Dose 9 × Dose Frequency 4, determined through random assignment. Word learning was tracked for each treatment via a definition task prior to, during, and after treatment. Results Results showed that children with DLD learned a significant number of words during treatment regardless of the dose and dose frequency format but that significant forgetting of newly learned words occurred in all formats once treatment was withdrawn. Individual differences in word learning were related to Clinical Evaluation of Language Fundamentals Core Language and Understanding Spoken Paragraphs scores. Conclusion When administered at an adequate intensity, variation in the dose and dose frequency of interactive book reading does not appear to influence word learning by children with DLD. Although interactive book reading continues to show promise as an effective word learning intervention for children with DLD, further development is needed to enhance the effectiveness of this treatment approach. Supplemental Material https://doi.org/10.23641/asha.9745181.",2019,Results Results showed that children with DLD learned a significant number of words during treatment regardless of the dose and dose frequency format but that significant forgetting of newly learned words occurred in all formats once treatment was withdrawn.,"['Method Thirty-four kindergarten children with DLD (aged 5;0-6;2 [years;months', 'children with DLD', 'Kindergarten Children', 'children with developmental language disorder (DLD', 'With Developmental Language Disorder']",[],"['Clinical Evaluation of Language Fundamentals Core Language and Understanding Spoken Paragraphs scores', 'Word learning']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023014', 'cui_str': 'Speech or Language, Developmental Disorder'}]",[],"[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0397097,Results Results showed that children with DLD learned a significant number of words during treatment regardless of the dose and dose frequency format but that significant forgetting of newly learned words occurred in all formats once treatment was withdrawn.,"[{'ForeName': 'Holly L', 'Initials': 'HL', 'LastName': 'Storkel', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Rouzana', 'Initials': 'R', 'LastName': 'Komesidou', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Mollee J', 'Initials': 'MJ', 'LastName': 'Pezold', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Adrienne R', 'Initials': 'AR', 'LastName': 'Pitt', 'Affiliation': 'Department of Speech-Language-Hearing: Sciences & Disorders, University of Kansas, Lawrence.'}, {'ForeName': 'Kandace K', 'Initials': 'KK', 'LastName': 'Fleming', 'Affiliation': 'Life Span Institute, University of Kansas, Lawrence.'}, {'ForeName': 'Rebecca Swinburne', 'Initials': 'RS', 'LastName': 'Romine', 'Affiliation': 'Life Span Institute, University of Kansas, Lawrence.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-VOIA-18-0131'] 1357,31599602,Parental report of outcomes from a randomized trial of in-home family services.,"This study conducted a randomized trial to examine the efficacy of the Boys Town In-Home Family Services (IHFS) program for families of high-risk youth. Participants were recruited from a state helpline for families struggling with poor family functioning and child emotional or behavioral issues. Consent was obtained for 300 of which 152 were randomly assigned to participate in IHFS for 3-4 months and 148 were assigned to the services as usual comparison group. For the families in the treatment group, 18% did not participant in the intervention, and 66% of families received 20 or more service hours. Parent report data were collected at intake, post, as well 6 and 12 months after post data collection. Data were collected on constructs such as caregiver strain, family functioning, parenting, family resources, and parent report of child behavior. Piecewise analyses of the intake to post data indicated significantly greater reductions in caregiver strain for the treatment condition. Given the conservative corrections for the use of multiple tests, no other measures demonstrated significant differences. For the piecewise model of the maintenance phase, there were no significant differences between groups aside from caregiver strain that showed a significant improvement for the comparison condition. Supplementary dose-response analyses indicated that for most families there was an ideal dosage of about 25-75 hr to bring about the largest improvements in caregiver strain, parenting skills, and child behavior. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Piecewise analyses of the intake to post data indicated significantly greater reductions in caregiver strain for the treatment condition.,"['Participants were recruited from a state helpline for families struggling with poor family functioning and child emotional or behavioral issues', 'Boys Town In-Home Family Services (IHFS) program for families of high-risk youth']",[],"['caregiver strain, parenting skills, and child behavior']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}]",152.0,0.046319,Piecewise analyses of the intake to post data indicated significantly greater reductions in caregiver strain for the treatment condition.,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Duppong Hurley', 'Affiliation': 'Department of Special Education and Communication Disorders, University of Nebraska-Lincoln.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Lambert', 'Affiliation': 'Department of Special Education and Communication Disorders, University of Nebraska-Lincoln.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Patwardhan', 'Affiliation': ""Father Flanagan's Boys Home.""}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Ringle', 'Affiliation': ""Father Flanagan's Boys Home.""}, {'ForeName': 'Ronald W', 'Initials': 'RW', 'LastName': 'Thompson', 'Affiliation': ""Father Flanagan's Boys Home.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Farley', 'Affiliation': 'Department of Special Education and Communication Disorders, University of Nebraska-Lincoln.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000594'] 1358,31608773,Functional ability is associated with higher adherence to behavioral interventions in mild cognitive impairment.,"Objective: Behavioral interventions during early memory decline hold promise in delaying the development of dementia. In the present study, participants in a multimodal behavioral intervention study were assessed for post-intervention adherence and predictors of adherence. Methods: Participants ( N  = 272, mean age = 75.04 ± 7.54) diagnosed with amnestic Mild Cognitive Impairment (aMCI) were assigned to intervention groups receiving four out of five behavioral intervention components, including yoga, memory compensation training, computerized cognitive training, support groups, and/or wellness education. Length of the intervention was 10 days, 4 h per day, with post-intervention follow-up at 6, 12, and 18 months. Results: Two-hundred and thirty-seven participants completed the 6-month post-intervention follow-up measures, 228 participants completed the 12-month measures, and 218 participants completed the 18-month measures. Participants fully adhered to a mean of 2 out of the 4 taught intervention components. Eighty-nine percent of participants were at least partially adherent to one or more taught intervention components at 6-, 12-, and 18-month post-intervention follow-up. Physical activity was the most adhered to intervention while group support was the least adhered to intervention across all three follow-up time-points. Higher educational level, higher baseline depressive symptoms, higher baseline global cognitive functioning, and better baseline and concurrent functional abilities were associated post-intervention adherence. Conclusion: Changes in functional abilities are associated with disease progression among persons with aMCI. In the present study, individuals with aMCI who have higher education, higher depressive symptoms, and better baseline functioning abilities are more likely to adhere to behavioral intervention components over time. Post-intervention adherence also associates with concurrent daily function.",2020,Physical activity was the most adhered to intervention while group support was the least adhered to intervention across all three follow-up time-points.,"['persons with aMCI', 'mild cognitive impairment', 'Eighty-nine percent of participants were at least partially adherent to one or more taught intervention components at 6-, 12-, and 18-month post-intervention follow-up', 'Participants ( N \u2009=\u2009272', 'individuals with aMCI who have higher education, higher depressive symptoms', 'Two-hundred and thirty-seven participants completed the 6-month post-intervention follow-up measures, 228 participants completed the 12-month measures, and 218 participants completed the 18-month measures', 'mean age\u2009=\u200975.04\u2009±\u20097.54) diagnosed with amnestic Mild Cognitive Impairment (aMCI']","['Behavioral interventions', 'behavioral intervention components, including yoga, memory compensation training, computerized cognitive training, support groups, and/or wellness education']","['Physical activity', 'Higher educational level, higher baseline depressive symptoms, higher baseline global cognitive functioning, and better baseline and concurrent functional abilities']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0424933', 'cui_str': 'Higher education (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",237.0,0.0943486,Physical activity was the most adhered to intervention while group support was the least adhered to intervention across all three follow-up time-points.,"[{'ForeName': 'Priscilla A Amofa', 'Initials': 'PAA', 'LastName': 'Sr', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'DeFeis', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'De Wit', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': ""O'Shea"", 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mejia', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Chandler', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Dona E C', 'Initials': 'DEC', 'LastName': 'Locke', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic Arizona, Scottsdale, AZ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fields', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic Minnesota, Rochester, MN, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Phatak', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Dean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Crook', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1672792'] 1359,30498827,Dairy-Based and Energy-Enriched Berry-Based Snacks Improve or Maintain Nutritional and Functional Status in Older People in Home Care.,"OBJECTIVE Consumption of energy- and nutrient-dense snacks are recommended for older people to maintain adequate nutrition. We evaluated the effects of dairy-based and energy-enriched berry products consumed as snacks on nutritional and functional status among vulnerable older people receiving home care services. DESIGN Randomised controlled study. SETTING AND PARTICIPANTS The study sample consisted of 85 home care clients, with mean age of 81.9 (SD 7.1) years in the intervention group (n=50) and 83.7 (SD 8.1) years in the control group (n=35), and 72% women in both groups. INTERVENTION In the intervention group, the participants consumed both high-protein dairy-based products and energy-enriched berry purées for three months. The snack products provided nearly 300 kcal and 14 g protein per day. MEASUREMENTS The Mini Nutritional Assessment (MNA), body mass index (BMI), mid-arm muscular area (MAMA) and concentrations of plasma albumin and prealbumin and blood haemoglobin were used to determine nutritional status, and handgrip strength was used to determine functional status at baseline and after the intervention. RESULTS After adjustment for age and gender, the intervention showed a significant effect on MNA scores (2.1, 95% [CI]: 1.0 to 3.3) (p=0.003), albumin concentration (2.0 g/L, 95% [CI]: 1.1 to 3.2) (p=0.006) and handgrip strength of the right hand in women (2.4 kg, 95% [CI]: 1.2 to 3.3) (p=0.007). The MNA scores improved in the intervention group, while albumin concentration and handgrip strength decreased in the control group. CONCLUSIONS Regular use of dairy- and energy-enriched berry-based snacks may improve or maintain nutritional and functional status among older people in home care.",2018,"The MNA scores improved in the intervention group, while albumin concentration and handgrip strength decreased in the control group. ","['older people to maintain adequate nutrition', 'vulnerable older people receiving home care services', 'older people in home care', 'Older People in Home Care', '85 home care clients, with mean age of 81.9 (SD 7.1) years in the intervention group (n=50) and 83.7 (SD 8.1) years in the control group (n=35), and 72% women in both groups']","['dairy- and energy-enriched berry-based snacks', 'dairy-based and energy-enriched berry products consumed as snacks', 'energy- and nutrient-dense snacks', 'Dairy-Based and Energy-Enriched Berry-Based Snacks']","['albumin concentration', 'Mini Nutritional Assessment (MNA), body mass index (BMI), mid-arm muscular area (MAMA) and concentrations of plasma albumin and prealbumin and blood haemoglobin', 'nutritional status, and handgrip strength', 'handgrip strength', 'albumin concentration and handgrip strength', 'MNA scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0019855', 'cui_str': 'Domiciliary Care'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1260311', 'cui_str': 'Plasma Albumin'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0005768'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0434736,"The MNA scores improved in the intervention group, while albumin concentration and handgrip strength decreased in the control group. ","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Nykänen', 'Affiliation': 'Irma Nykänen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211 Kuopio, Finland Phone: +358 40 355 2991, Fax: +358 17 162 131, E-mail: Irma.Nykanen@uef.fi.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Törrönen', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schwab', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-018-1076-7'] 1360,31599810,Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial.,"OBJECTIVE To evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline. BACKGROUND SSI is a common complication after gastrointestinal surgery. To date, there is a lack of evidence whether subcutaneous wound irrigation is beneficial in terms of reduction of SSI. METHODS The RECIPE trial was an investigator initiated single-center, single-blind prospective, randomized controlled trial with 2 parallel treatment groups, comparing wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution in elective laparotomies. Primary endpoint was the rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria. RESULTS Between February 02, 2015, and May 23, 2018, 456 patients were randomly assigned to saline (n = 228) or polyhexanide (n = 228). Final cohort for analysis comprised 393 patients (202 in the saline and 191 in the polyhexanide group). Overall rate of SSI was 28.2%, n = 111. Simple analysis with cross tabulation revealed that significantly fewer SSIs occurred in the polyhexanide group: n = 70 (34.7%) versus n = 41 (21.5%); P = 0.004. In a multiple logistic regression model the factor wound irrigation with polyhexanide [odds ratio (OR) 0.44; 95% confidence interval (CI) 0.27-0.72; P = 0.001) was associated with risk reduction of SSI. Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI. CONCLUSIONS Intraoperative subcutaneous wound irrigation with antiseptic 0.04% polyhexanide solution is effective in reducing SSI after elective laparotomies.",2020,"Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI. ","['Between February 02, 2015, and May 23, 2018, 456 patients', '393 patients (202 in the saline and 191 in the polyhexanide group']","['Antiseptica (RECIPE', 'intraoperative subcutaneous wound irrigation with 0.04% polyhexanide', 'saline', 'antiseptic 0.04% polyhexanide solution', 'wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution', 'polyhexanide']","['Overall rate of SSI', 'SSIs', 'rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria', 'surgical site infection (SSI', 'risk reduction of SSI', 'Preoperative anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0150410', 'cui_str': 'Irrigation of wound (procedure)'}, {'cui': 'C4517407', 'cui_str': 'Zero point zero four'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",456.0,0.287261,"Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI. ","[{'ForeName': 'Rahel M', 'Initials': 'RM', 'LastName': 'Strobel', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Leonhardt', 'Affiliation': 'Innlandet Hospital Trust, Norwegian National Advisory Unit on Concurrent Substance Abuse and Mental Health Disorders, Brumunddal, Norway.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Krochmann', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Neumann', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Speichinger', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartmann', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Lucas D', 'Initials': 'LD', 'LastName': 'Lee', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Daum', 'Affiliation': 'Department of Gastroenterology, Rheumatology and Infectious Diseases, Charité Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Kreis', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Lauscher', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000003645'] 1361,29110187,Outcomes from a community-based hypertension educational programme: the West of Ireland Hypertension study.,"BACKGROUND Hypertension is a leading modifiable risk factor for premature cardiovascular disease. Research indicates a growing prevalence of hypertension among adults worldwide, with accompanying low levels of patient knowledge, and sub-optimal clinical management. AIMS This study aims to explore the impact of a structured hypertension educational intervention on patient knowledge, lifestyle behaviours and blood pressure control. DESIGN An observational, prospective cohort design was selected. METHODS Participants were recruited through a public blood pressure screening event in a community-based setting. They were asked to complete a self-report questionnaire followed by an assessment of their blood pressure. Participants with high blood pressure were randomly assigned to either a control group or an intervention group. Those in the intervention group received an educational intervention on hypertension 4 weeks later. Both groups were recalled 4 months later for a repeat of the same initial assessment. RESULTS Eighty-one participants with a mean age of 64 years were included in this study. There were no significant differences in the baseline measures between the two groups. Significant improvements were found in the intervention group compared with the control group in levels of hypertension knowledge and awareness (p = <0.001), exercise levels (p = 0.002) and weight (p = 0.003). Participants who underwent the intervention showed a greater reduction in both systolic (SBP) and diastolic (DBP) blood pressure (SBP 158.8 to 141.6 mmHg, p < 0.0001 and DBP 84.7 to 77.7 mmHg, p < 0.001). CONCLUSION Providing a tailored educational intervention can positively impact on hypertension knowledge, self-care management and control within community-based settings.",2018,"Providing a tailored educational intervention can positively impact on hypertension knowledge, self-care management and control within community-based settings.","['Participants with high blood pressure', 'Participants were recruited through a public blood pressure screening event in a community-based setting', 'Eighty-one participants with a mean age of 64\xa0years']","['educational intervention', 'community-based hypertension educational programme', 'tailored educational intervention', 'structured hypertension educational intervention', 'control group or an intervention group']","['levels of hypertension knowledge and awareness', 'patient knowledge, lifestyle behaviours and blood pressure control', 'exercise levels', 'systolic (SBP) and diastolic (DBP) blood pressure']","[{'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",81.0,0.0350492,"Providing a tailored educational intervention can positively impact on hypertension knowledge, self-care management and control within community-based settings.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Darrat', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland. miladmustafa7@yahoo.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Houlihan', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gibson', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabbitt', 'Affiliation': 'Croí, West of Ireland Cardiac Foundation, Galway, Ireland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Flaherty', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}]",Irish journal of medical science,['10.1007/s11845-017-1706-9'] 1362,31600472,Learning While Playing: A Randomized Trial of Serious Games as a Tool for Word Mastery.,"Objectives The aim of this study was to determine whether college students build their vocabularies by playing a serious game that incorporates principles of learning and memory. Design This study used a single-site, prospective, randomized trial with 2 branches: immediate and delayed treatment. Outcome measures were obtained after a 1-month intervention and, for the immediate group only, after a 1-month retention interval. Setting College students from the University of Iowa were recruited via mass e-mail. The intervention took place in the participants' homes; the testing took place in a university laboratory. Participants Forty undergraduates (32 women, 8 men) who planned to take the Graduate Record Examinations (GRE; Educational Testing Service, 2018) within the year following the treatment participated in the study. Participants were allocated to 1 of the 2 treatment branches via biased coin randomization. Intervention The treatment consisted of vocabulary training on Vocabulary.com for a minimum of 20 min (dose) 4 times per week (frequency) for 4 weeks (treatment duration), for a total cumulative treatment intensity of 320 min. Outcome Measures The prespecified primary outcome measures of word learning were the number of words mastered during Vocabulary.com play and the percentage of mastered words accurately defined. The depth of information included in the definitions was a secondary outcome. The prespecified primary outcome measure of functional impact was change in the verbal GRE practice test scores from pre- to posttreatment. The examiners scoring the definitions were blind to treatment assignment. All other outcomes were measured automatically by the relevant computer program so blinding was moot. Results The participants averaged 5.33 hr of play during the treatment interval and mastered 124 words. Amount of play and mastery were highly correlated. Accuracy of definitions was 55% or 59% (depending on treatment branch) after treatment and 55% 1 month later, an insignificant decline. The game itself did not result in GRE gains, but participants who mastered more words per minute of play had higher GRE scores than other participants. Conclusion Vocabulary.com, an evidence-based game, showed promise as a way to build vocabulary knowledge, but at the intensity of treatment provided, it did not result in gains in high-stakes test performance. Trial Registration This trial was not preregistered. Supplemental Material https://doi.org/10.23641/asha.9936374.",2019,"Accuracy of definitions was 55% or 59% (depending on treatment branch) after treatment and 55% 1 month later, an insignificant decline.","['Setting College students from the University of Iowa were recruited via mass e-mail', 'college students', 'Participants Forty undergraduates (32 women, 8 men) who planned to take the Graduate Record Examinations (GRE; Educational Testing Service, 2018) within the year following the treatment participated in the study']","['Intervention', 'Supplemental Material https://doi.org/10.23641/asha.9936374', 'vocabulary training']","['functional impact', 'verbal GRE practice test scores', 'word learning were the number of words mastered during Vocabulary.com play and the percentage of mastered words accurately defined', 'GRE scores', 'GRE gains']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0018122', 'cui_str': 'Graduate Records Examination'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",32.0,0.146163,"Accuracy of definitions was 55% or 59% (depending on treatment branch) after treatment and 55% 1 month later, an insignificant decline.","[{'ForeName': 'Karla K', 'Initials': 'KK', 'LastName': 'McGregor', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Marshall', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}, {'ForeName': 'Samantha K', 'Initials': 'SK', 'LastName': 'Julian', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, The University of Iowa, Iowa City.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-VOIA-18-0121'] 1363,31600473,The Effect of Vocabulary Intervention on Text Comprehension: Who Benefits?,"Purpose Vocabulary intervention can improve comprehension of texts containing taught words, but it is unclear if all middle school readers get this benefit. This study tests 2 hypotheses about variables that predict response to vocabulary treatment on text comprehension: gains in vocabulary knowledge due to treatment and pretreatment reading comprehension scores. Method Students in Grade 6 ( N = 23) completed a 5-session intervention based on robust vocabulary instruction (RVI). Knowledge of the semantics of taught words was measured pre- and posttreatment. Participants then read 2 matched texts, 1 containing taught words (treated) and 1 not (untreated). Treated texts and taught word lists were counterbalanced across participants. The difference between text comprehension scores in treated and untreated conditions was taken as a measure of the effect of RVI on text comprehension. Results RVI resulted in significant gains in knowledge of taught words ( d RM = 2.26) and text comprehension ( d RM = 0.31). The extent of gains in vocabulary knowledge after vocabulary treatment did not predict the effect of RVI on comprehension of texts. However, untreated reading comprehension scores moderated the effect of the vocabulary treatment on text comprehension: Lower reading comprehension was associated with greater gains in text comprehension. Readers with comprehension scores below the mean experienced large gains in comprehension, but those with average/above average reading comprehension scores did not. Conclusion Vocabulary instruction had a larger effect on text comprehension for readers in Grade 6 who had lower untreated reading comprehension scores. In contrast, the amount that children learned about taught vocabulary did not predict the effect of vocabulary instruction on text comprehension. This has implications for the identification of 6th-grade students who would benefit from classroom instruction or clinical intervention targeting vocabulary knowledge.",2019,Results RVI resulted in significant gains in knowledge of taught words ( d RM = 2.26) and text comprehension ( d RM = 0.31).,['Method Students in Grade 6 ( N = 23) completed a'],"['Vocabulary Intervention', '5-session intervention based on robust vocabulary instruction (RVI']","['text comprehension', 'text comprehension scores', 'Text Comprehension', 'knowledge of taught words']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0188581,Results RVI resulted in significant gains in knowledge of taught words ( d RM = 2.26) and text comprehension ( d RM = 0.31).,"[{'ForeName': 'Dawna', 'Initials': 'D', 'LastName': 'Duff', 'Affiliation': 'Department of Communication Science and Disorders, University of Pittsburgh, PA.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-VOIA-18-0001'] 1364,29094414,Chronic sleep restriction differentially affects implicit biases toward food among men and women: preliminary evidence.,"Chronic sleep restriction and obesity are two major public health concerns. This study investigated how chronic sleep restriction changes implicit attitudes towards low- and high-calorie foods. In a randomized, counterbalanced cross-over design, 17 participants (eight females, nine males) underwent two laboratory testing sessions where they were either sleep-restricted for 3 weeks (i.e. underwent three weekly cycles of 5 nights of 4 h of sleep followed by 2 nights of 8 h of sleep opportunity) or received 3 weeks of control sleep (i.e. 8 h of sleep opportunity per night for 3 weeks). There was evidence for a significant sleep condition x sex interaction (F (1, 20)  = 4.60, P = 0.04). After chronic sleep restriction, men showed a trend towards a significant decrease in their implicit attitudes favouring low-calorie foods (P = 0.08), whereas women did not show a significant change (P = 0.16). Men may be at increased risk of weight gain when sleep-deprived due to a reduced bias towards low-calorie foods.",2018,"After chronic sleep restriction, men showed a trend towards a significant decrease in their implicit attitudes favouring low-calorie foods (P = 0.08), whereas women did not show a significant change (P = 0.16).","['men and women', '17 participants (eight females, nine males']","['5 nights of 4\xa0h of sleep followed by 2 nights of 8\xa0h of sleep opportunity) or received 3\xa0weeks of control sleep', 'chronic sleep restriction changes implicit attitudes towards low- and high-calorie foods']","['sleep condition x sex interaction', 'weight gain', 'implicit attitudes favouring low-calorie foods']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0453838', 'cui_str': 'Low energy food (substance)'}]",17.0,0.0199014,"After chronic sleep restriction, men showed a trend towards a significant decrease in their implicit attitudes favouring low-calorie foods (P = 0.08), whereas women did not show a significant change (P = 0.16).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Alkozei', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'William D S', 'Initials': 'WDS', 'LastName': 'Killgore', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Dailey', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Bajaj', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Raikes', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Haack', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]",Journal of sleep research,['10.1111/jsr.12629'] 1365,31609137,The impact of chewing gum on postoperative bowel activity and postoperative pain after total laparoscopic hysterectomy.,"We aimed to investigate the effects of chewing gum on bowel activity and postoperative pain in patients undergoing laparoscopic hysterectomy. Patients were randomised into two groups ( n  = 58, study; n  = 51, control). In the study group, patients started chewing sugarless gum every 2 h for 15 min, beginning at the second postoperative hour. The control group did not chew gum, and they received standard postoperative care. Both groups were compared primarily in terms of the amount of time until the first bowel movement, the time of the first passage of flatus and the time of first defaecation. The amount of time until the first bowel movement, the time of the first passage of flatus and the time of the first defaecation were found to be significantly shorter in the chewing gum group ( p  < .001). The amount of postoperative analgesics that were needed and VAS scores at 6-hours and 24-hours postoperatively, were found to be lower in the study group than in the control group ( p  < .001). Chewing gum was found to have beneficial effects on bowel motility and postoperative pain in patients undergoing laparoscopic hysterectomy. This affordable and simple method could be recommended to patients after total laparoscopic hysterectomy.Impact statement What is already known on this subject? Postoperative gastrointestinal dysfunction remains a source of morbidity and the major determinant of length of stay after abdominal operation. The mechanism of enhanced recovery from postoperative gastrointestinal dysfunction with the help of chewing gum is believed to be the cephalic-vagal stimulation of digestion which increases the promotability of neural and humoral factors that act on different parts of the gastrointestinal tract. What do the results of this study add? The findings of previous randomised controlled studies have been inconsistent regarding the effect of chewing gum on postoperative bowel function following abdominal gynecological surgery. In this randomised prospective study, we found that chewing gum early in the postoperative period after total laparoscopic hysterectomy hastened time to bowel motility and flatus. To our knowledge this is the first study of the impact of chewing gum on bowel motility after total laparoscopic hysterectomy. What are the implications of these findings for clinical practice and/or further research? Chewing gum early in the postoperative period following laparoscopic hysterectomy hastens time to bowel motility and flatus. The use of chewing gum is a simple and cheap strategy for promoting the recovery of gastrointestinal functions.",2020,"Both groups were compared primarily in terms of the amount of time until the first bowel movement, the time of the first passage of flatus and the time of first defaecation.","['abdominal gynecological surgery', 'patients after total laparoscopic hysterectomy', 'patients undergoing laparoscopic hysterectomy', 'after total laparoscopic hysterectomy']",['chewing gum'],"['amount of time until the first bowel movement, the time of the first passage of flatus and the time of first defaecation', 'bowel activity and postoperative pain', 'VAS scores', 'bowel motility and postoperative pain', 'postoperative bowel activity and postoperative pain', 'bowel motility', 'bowel motility and flatus', 'amount of time until the first bowel movement, the time of the first passage of flatus and the time of the first defaecation']","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}]","[{'cui': 'C4321298', 'cui_str': 'Chewing gum'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.0148859,"Both groups were compared primarily in terms of the amount of time until the first bowel movement, the time of the first passage of flatus and the time of first defaecation.","[{'ForeName': 'Ünal', 'Initials': 'Ü', 'LastName': 'Turkay', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Yavuz', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'İsmet', 'Initials': 'İ', 'LastName': 'Hortu', 'Affiliation': 'Department of Obstetrics & Gynecology, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Terzi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kale', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences Derince Training and Research Hospital, Kocaeli, Turkey.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1652891'] 1366,31595499,Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension.,"BACKGROUND Dupilumab (monoclonal antibody inhibiting IL-4/IL-13 signalling) is approved for use in adolescents aged ≥ 12 years with inadequately controlled moderate-to-severe atopic dermatitis (AD). Dupilumab significantly improved AD signs/symptoms in a 16-week, randomised, placebo-controlled phase III trial in adolescents (NCT03054428). OBJECTIVES To characterize the pharmacokinetics of dupilumab, and long-term safety and efficacy in adolescents. METHODS This was a global, multicentre, phase IIa, open-label, ascending-dose, sequential cohort study with a phase III open-label extension (OLE) in adolescents with moderate-to-severe AD. In the phase IIa study, patients received one dupilumab dose (2 mg kg -1 or 4 mg kg -1 ) and 8 weeks of pharmacokinetic sampling. Thereafter, patients received the same dose weekly for 4 weeks, with 8-week safety follow-up. Patients then enrolled in the OLE, continuing 2 mg kg -1 or 4 mg kg -1 dupilumab weekly. Primary end points were dupilumab concentration-time profile and incidence of treatment-emergent adverse events (TEAEs). Secondary outcomes included Eczema Area and Severity Index (EASI). RESULTS Forty adolescents received dupilumab in the phase IIa study; 36 enrolled in the OLE. Dupilumab showed nonlinear, target-mediated pharmacokinetics. Mean ± SD trough dupilumab concentrations in serum at week 48 (OLE) were 74 ± 19 mg L -1 and 161 ± 60 mg L -1 for 2 mg kg -1 and 4 mg kg -1 , respectively. Dupilumab was well tolerated over 52 weeks; the most common TEAEs were nasopharyngitis (week 52: 41% [2 mg kg -1 ], 47% [4 mg kg -1 ]) and AD exacerbation (29%, 42%). After one dupilumab dose in the phase IIa study, EASI improved from baseline to week 2 [mean ± SD reduction -34% ± 20% (2 mg kg -1 ) and -51% ± 29% (4 mg kg -1 )]. With continuing treatment, EASI scores improved further [week 52: -85% ± 12% (2 mg kg -1 ) and -84% ± 20% (4 mg kg -1 )]. CONCLUSIONS In adolescents with moderate-to-severe AD, dupilumab's pharmacokinetic profile was similar to that in adults. These 52-week safety and efficacy data support long-term use of dupilumab in this patient population. What's already known about this topic? Adolescents with moderate-to-severe atopic dermatitis (AD) have high unmet medical need, with significant disease burden and limited treatment options. Dupilumab (monoclonal antibody against interleukin-4 receptor α) is approved for the treatment of adolescents with moderate-to-severe AD who are inadequately responsive to standard of care (U.S.A.) or candidates for systemic therapy (European Union). A 16-week, randomized, placebo-controlled phase III trial in adolescents demonstrated significant improvements in AD signs/symptoms with an acceptable safety profile. What does this study add? These studies demonstrate the long-term safety and efficacy of dupilumab in adolescents with moderate-to-severe AD for up to 52 weeks of treatment, thus extending and reinforcing the findings from the 16-week dupilumab phase III trial. The data from these studies also support the use of dupilumab in combination with current standard of care (topical corticosteroids), which was not evaluated in the 16-week phase III monotherapy trial.",2020,"With continuing treatment, EASI scores improved further [week 52: -85% ± 12% (2 mg kg -1 ) and -84% ± 20% (4 mg kg -1 )]. ","['adolescents with uncontrolled moderate-to-severe atopic dermatitis', 'adolescents', 'adolescents aged ≥ 12 years with inadequately controlled moderate-to-severe atopic dermatitis (AD', 'adolescents with moderate-to-severe AD who are inadequately responsive to standard of care (U.S.A.) or candidates for systemic therapy (European Union', 'adolescents with moderate-to-severe AD', 'Forty adolescents received dupilumab in the phase IIa study; 36 enrolled in the OLE', 'Adolescents with moderate-to-severe atopic dermatitis (AD']","['placebo', 'Dupilumab (monoclonal antibody against interleukin-4 receptor α', 'phase III open-label extension (OLE', 'dupilumab in combination with current standard of care (topical corticosteroids', 'dupilumab', 'Dupilumab']","['tolerated', 'Eczema Area and Severity Index (EASI', 'nasopharyngitis', 'AD exacerbation', 'EASI scores', 'dupilumab concentration-time profile and incidence of treatment-emergent adverse events (TEAEs', 'AD signs/symptoms', 'Mean ± SD trough dupilumab concentrations']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0123771', 'cui_str': 'Receptors, IL-4'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}]",40.0,0.077416,"With continuing treatment, EASI scores improved further [week 52: -85% ± 12% (2 mg kg -1 ) and -84% ± 20% (4 mg kg -1 )]. ","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': ""The University of Sheffield, Sheffield Children's Hospital, Sheffield, U.K.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ""University of California San Diego, Rady Children's Hospital, San Diego, CA, U.S.A.""}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Arkwright', 'Affiliation': ""University of Manchester, Royal Manchester Children's Hospital, Manchester, U.K.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'DiCioccio', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18476'] 1367,29532078,Comparison of Surgical and Medical Therapy for Type 2 Diabetes in Severely Obese Adolescents.,"Importance Because of the substantial increase in the occurrence of type 2 diabetes in the pediatric population and the medical complications of this condition, therapies are urgently needed that will achieve better glycemic control than standard medical management. Objective To compare glycemic control in cohorts of severely obese adolescents with type 2 diabetes undergoing medical and surgical interventions. Design, Setting, and Participants A secondary analysis of data collected by the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) consortia was performed. Teen-LABS enrolled 242 adolescents (≤19 years of age) from March 1, 2007, through December 31, 2011. TODAY randomized 699 participants (aged 10-17 years) from July 24, 2004, through February 25, 2009. Data analysis was performed from July 6, 2015, to June 24, 2017. Anthropometric, clinical, and laboratory data from adolescents with severe obesity and type 2 diabetes who underwent treatment with metabolic or bariatric surgery in the Teen-LABS study or medical therapy in the TODAY study were compared. Interventions Teen-LABS participants underwent a primary bariatric surgical procedure; TODAY participants were randomized to receive metformin therapy alone or in combination with rosiglitazone or an intensive lifestyle intervention; insulin therapy was given in cases of progression of disease. Main Outcomes and Measures Glycemic control, body mass index, prevalence of elevated blood pressure, dyslipidemia, abnormal kidney function, and clinical adverse events were measured. Results Data from 30 participants from Teen-LABS (mean [SD] age at baseline, 16.9 [1.3] years; 21 [70%] female; 18 [66%] white) and 63 from TODAY (mean [SD] age at baseline, 15.3 [1.3] years; 28 [44%] female; 45 [71%] white) were analyzed. During 2 years, mean hemoglobin A1c concentration decreased from 6.8% (95% CI, 6.4%-7.3%) to 5.5% (95% CI, 4.7% -6.3%) in Teen-LABS and increased from 6.4% (95% CI, 6.1%-6.7%) to 7.8% (95% CI, 7.2%-8.3%) in TODAY. Compared with baseline, the body mass index decreased by 29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY. Twenty-three percent of Teen-LABS participants required a subsequent operation during the 2-year follow-up. Conclusions and Relevance Compared with medical therapy, surgical treatment of severely obese adolescents with type 2 diabetes was associated with better glycemic control, reduced weight, and improvement of other comorbidities. These data support the need for a well-designed, prospective controlled study to define the role of surgery for adolescents with type 2 diabetes, including health and surgical outcomes.",2018,"Compared with baseline, the body mass index decreased by 29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY.","['severely obese adolescents with type 2 diabetes', 'Interventions\n\n\nTeen-LABS participants underwent a primary bariatric surgical procedure; TODAY participants', 'Type 2 Diabetes in Severely Obese Adolescents', '699 participants (aged 10-17 years) from July 24, 2004, through February 25, 2009', 'adolescents with severe obesity and type 2 diabetes who underwent treatment with metabolic or bariatric surgery in the Teen-LABS study or medical therapy in the TODAY study were compared', 'cohorts of severely obese adolescents with type 2 diabetes undergoing medical and surgical interventions', '30 participants from Teen-LABS (mean [SD] age at baseline, 16.9 [1.3] years; 21 [70%] female; 18 [66%] white) and 63 from TODAY (mean [SD] age at baseline, 15.3 [1.3] years; 28 [44%] female; 45 [71%] white) were analyzed', 'adolescents with type 2 diabetes', 'Teen-LABS enrolled 242 adolescents (≤19 years of age) from March 1, 2007, through December 31, 2011']","['metformin therapy alone or in combination with rosiglitazone or an intensive lifestyle intervention; insulin therapy', 'Bariatric Surgery (Teen-LABS', 'Surgical and Medical Therapy']","['body mass index', 'Measures\n\n\nGlycemic control, body mass index, prevalence of elevated blood pressure, dyslipidemia, abnormal kidney function, and clinical adverse events', 'mean hemoglobin A1c concentration']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517578', 'cui_str': '15.3'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",699.0,0.0702868,"Compared with baseline, the body mass index decreased by 29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY.","[{'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Inge', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital Colorado, University of Colorado, Denver, Aurora.""}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Department of Pediatrics, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Jenkins', 'Affiliation': ""Department of Pediatrics and Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Natasha I', 'Initials': 'NI', 'LastName': 'Leibel', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, New York.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Brandt', 'Affiliation': ""Michael E. Debakey Department of Surgery, Texas Children's Hospital, Baylor College of Medicine, Houston.""}, {'ForeName': 'Morey', 'Initials': 'M', 'LastName': 'Haymond', 'Affiliation': ""Michael E. Debakey Department of Surgery, Texas Children's Hospital, Baylor College of Medicine, Houston.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Department of Pediatrics and Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Lawrence M', 'Initials': 'LM', 'LastName': 'Dolan', 'Affiliation': ""Department of Pediatrics and Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado, Denver, Aurora.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2017.5763'] 1368,31593484,Oxaliplatin-Based Adjuvant Chemotherapy for Rectal Cancer After Preoperative Chemoradiotherapy (ADORE): Long-Term Results of a Randomized Controlled Trial.,"PURPOSE We evaluated the role of oxaliplatin as adjuvant chemotherapy in patients with rectal cancer who received preoperative chemoradiotherapy (CRT) with fluoropyrimidine monotherapy and total mesorectal excision (TME). METHODS The ADORE trial (adjuvant oxaliplatin in rectal cancer) is a multicenter, randomized trial in patients with postoperative ypStage II (ypT3-4N0) or III (ypT any N1-2) rectal cancer after fluoropyrimidine-based preoperative CRT and TME. Patients were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL (fluorouracil 380 mg/m 2 and leucovorin 20 mg/m 2 ) or FOLFOX (oxaliplatin 85 mg/m 2 , leucovorin 200 mg/m 2 , and fluorouracil bolus 400 mg/m 2 on day 1, fluorouracil infusion 2,400 mg/m 2 for 46 hours). Stratification factors included ypStage and participating center. Primary end point was disease-free survival (DFS). RESULTS A total of 321 patients were enrolled between November 19, 2008, and June 12, 2012. Six-year DFS rates were 68.2% in the FOLFOX arm versus 56.8% in the FL arm, with a stratified hazard ratio of 0.63 (95% CI, 0.43 to 0.93; P = .018) by intention-to-treat analysis. In the subgroup analysis for DFS, FOLFOX was favorable versus FL in patients with ypStage III, ypN1b, ypN2, high-grade histology, minimally regressed tumor, and an absence of lymphovascular or perineural invasion. Six-year overall survival rate was 78.1% in the FOLFOX arm versus76.4% in the FL arm (hazard ratio, 0.73; 95% CI, 0.45 to 1.19; P = .21). In the subgroup analysis for OS, FOLFOX was favorable versus FL in patients with ypN2 and minimally regressed tumor. CONCLUSION Adjuvant FOLFOX improved DFS in patients with rectal cancer with ypStage II and III disease after preoperative CRT. Adjuvant FOLFOX may be considered on the basis of the postoperative pathologic stage in those who received preoperative CRT and TME.",2019,"In the subgroup analysis for DFS, FOLFOX was favorable versus FL in patients with ypStage III, ypN1b, ypN2, high-grade histology, minimally regressed tumor, and an absence of lymphovascular or perineural invasion.","['rectal cancer', '321 patients were enrolled between November 19, 2008, and June 12, 2012', 'patients with rectal cancer with ypStage II and III disease after preoperative CRT', 'patients with postoperative ypStage II (ypT3-4N0) or III', 'Rectal Cancer', 'patients with rectal cancer who received']","['adjuvant chemotherapy either with FL (fluorouracil 380 mg/m 2 and leucovorin 20 mg/m 2 ) or FOLFOX (oxaliplatin 85 mg/m 2 , leucovorin 200 mg/m 2 , and fluorouracil bolus 400', 'FOLFOX', 'Preoperative Chemoradiotherapy (ADORE', 'Oxaliplatin-Based Adjuvant Chemotherapy', 'preoperative chemoradiotherapy (CRT) with fluoropyrimidine monotherapy and total mesorectal excision (TME', 'fluorouracil', 'fluoropyrimidine-based preoperative CRT and TME', 'Adjuvant FOLFOX', 'oxaliplatin']","['Six-year overall survival rate', 'disease-free survival (DFS', 'Six-year DFS rates', 'DFS']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4276318', 'cui_str': 'Leucovorin 200 MG'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",321.0,0.157101,"In the subgroup analysis for DFS, FOLFOX was favorable versus FL in patients with ypStage III, ypN1b, ypN2, high-grade histology, minimally regressed tumor, and an absence of lymphovascular or perineural invasion.","[{'ForeName': 'Yong Sang', 'Initials': 'YS', 'LastName': 'Hong', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'The Institute of Advanced Clinical and Biomedical Research, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu-Pyo', 'Initials': 'KP', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon Oh', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Baek', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seok-Byung', 'Initials': 'SB', 'LastName': 'Lim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chang Sik', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Cheon', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Hyeon', 'Initials': 'SH', 'LastName': 'Yun', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Hong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Chul', 'Initials': 'HC', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00016'] 1369,31474354,"Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial.","BACKGROUND Platinum-based chemotherapy is the foundation of treatment for platinum-sensitive recurrent ovarian cancer, but has substantial toxicity. Bevacizumab and maintenance poly(ADP-ribose) polymerase (PARP) inhibitors both significantly improve efficacy versus standard therapy, primarily in terms of progression-free survival, and offer the potential for chemotherapy-free treatment. AVANOVA2 compared niraparib and bevacizumab versus niraparib alone as definitive treatment for platinum-sensitive recurrent ovarian cancer. METHODS This open-label, randomised, phase 2, superiority trial in 15 university hospitals in Denmark, Sweden, Finland, Norway, and the USA enrolled women aged 18 years or older with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer. Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2, and had to have previously received platinum-containing therapy for primary disease but ≤1 prior non-platinum-containing regimen for recurrent disease. Previous treatment with bevacizumab or first-line maintenance PARP inhibitors was permitted. Eligible patients were randomly assigned 1:1 (by random permuted blocks with block sizes of two and four, no masking), stratified by homologous recombination deficiency status and chemotherapy-free interval, to receive once-daily oral niraparib 300 mg alone or with intravenous bevacizumab 15 mg/kg once every 3 weeks until disease progression. The primary endpoint was progression-free survival, assessed by the investigators in the intention-to-treat population after events in at least 62 patients. Safety was analysed in all patients who received at least one dose of study drug. This ongoing trial is registered with ClinicalTrials.gov, number NCT02354131. FINDINGS Between May 23, 2016, and March 6, 2017, 97 patients were enrolled and randomly assigned: 48 to niraparib plus bevacizumab and 49 to single-agent niraparib. Median follow-up was 16·9 months (IQR 15·4-20·9). Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months [95% CI 8·5-16·7] vs 5·5 months [3·8-6·3], respectively; adjusted hazard ratio [HR] 0·35 [95% CI 0·21-0·57], p<0·0001). Grade 3 or worse adverse events occurred in 31 (65%) of 48 patients who received niraparib plus bevacizumab and 22 (45%) of 49 who received single-agent niraparib. The most common grade 3 or worse adverse events in both groups were anaemia (7 [15%] of 48 vs 9 [18%] of 49) and thrombocytopenia (5 [10%] vs 6 [12%]), and hypertension in the combination group (10 [21%] vs 0). Niraparib plus bevacizumab was associated with increased incidences of any-grade proteinuria (10 [21%] of 48 patients vs 0) and hypertension (27 [56%] of 48 vs 11 [22%] of 49) compared with niraparib alone. No treatment-related deaths occurred. INTERPRETATION The efficacy observed with this chemotherapy-free combination of approved agents in women with platinum-sensitive recurrent ovarian cancer warrants further evaluation. A randomised phase 3 trial investigating niraparib plus bevacizumab versus chemotherapy plus bevacizumab in platinum-sensitive recurrent ovarian cancer is planned. FUNDING Nordic Society of Gynaecological Oncology and Tesaro.",2019,Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months,"['platinum-sensitive recurrent ovarian cancer', 'Eligible patients', 'Between May 23, 2016, and March 6, 2017, 97 patients were enrolled and randomly assigned: 48 to', 'Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2, and had to have previously received platinum-containing therapy for primary disease but ≤1 prior non-platinum-containing regimen for recurrent disease', 'women with platinum-sensitive recurrent ovarian cancer', '15 university hospitals in Denmark, Sweden, Finland, Norway, and the USA enrolled women aged 18 years or older with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer', 'platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24']","['niraparib alone', 'bevacizumab', 'Niraparib plus bevacizumab', 'niraparib and bevacizumab', 'block sizes of two and four, no masking), stratified by homologous recombination deficiency status and chemotherapy-free interval, to receive once-daily oral niraparib 300 mg alone or with intravenous bevacizumab', 'AVANOVA2', 'Bevacizumab and maintenance poly(ADP-ribose) polymerase (PARP) inhibitors', 'Platinum-based chemotherapy', 'niraparib plus bevacizumab', 'chemotherapy plus bevacizumab']","['Grade 3 or worse adverse events', 'adverse events', 'progression-free survival', 'incidences of any-grade proteinuria', 'thrombocytopenia', 'hypertension', 'anaemia', 'Safety']","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",97.0,0.32479,Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months,"[{'ForeName': 'Mansoor Raza', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: mansoor.raza.mirza@regionh.dk.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Åvall Lundqvist', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'dePont Christensen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Research Unit of General Practice University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gitte-Bettina', 'Initials': 'GB', 'LastName': 'Nyvang', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Malander', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Anttila', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Werner', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lindahl', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sakari', 'Initials': 'S', 'LastName': 'Hietanen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Peen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dimoula', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Roed', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ør Knudsen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Synnöve', 'Initials': 'S', 'LastName': 'Staff', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology and Tays Cancer Centre, Faculty of Medicine and Health Technology, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Krog Vistisen', 'Affiliation': 'Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Bjørge', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway; Center for Cancer Biomarkers CCBIO, Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Johanna U', 'Initials': 'JU', 'LastName': 'Mäenpää', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology and Tays Cancer Centre, Faculty of Medicine and Health Technology, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30515-7'] 1370,28698987,"The effects of traditional, superset, and tri-set resistance training structures on perceived intensity and physiological responses.","PURPOSE Investigate the acute and short-term (i.e., 24 h) effects of traditional (TRAD), superset (SS), and tri-set (TRI) resistance training protocols on perceptions of intensity and physiological responses. METHODS Fourteen male participants completed a familiarisation session and three resistance training protocols (i.e., TRAD, SS, and TRI) in a randomised-crossover design. Rating of perceived exertion, lactate concentration ([Lac]), creatine kinase concentration ([CK]), countermovement jump (CMJ), testosterone, and cortisol concentrations was measured pre, immediately, and 24-h post the resistance training sessions with magnitude-based inferences assessing changes/differences within/between protocols. RESULTS TRI reported possible to almost certainly greater efficiency and rate of perceived exertion, although session perceived load was very likely lower. SS and TRI had very likely to almost certainly greater lactate responses during the protocols, with changes in [CK] being very likely and likely increased at 24 h, respectively. At 24-h post-training, CMJ variables in the TRAD protocol had returned to baseline; however, SS and TRI were still possibly to likely reduced. Possible increases in testosterone immediately post SS and TRI protocols were reported, with SS showing possible increases at 24-h post-training. TRAD and SS showed almost certain and likely decreases in cortisol immediately post, respectively, with TRAD reporting likely decreases at 24-h post-training. CONCLUSIONS SS and TRI can enhance training efficiency and reduce training time. However, acute and short-term physiological responses differ between protocols. Athletes can utilise SS and TRI resistance training, but may require additional recovery post-training to minimise effects of fatigue.",2017,"TRAD and SS showed almost certain and likely decreases in cortisol immediately post, respectively, with TRAD reporting likely decreases at 24-h post-training. ",['Fourteen male participants completed a'],"['traditional (TRAD), superset (SS), and tri-set (TRI) resistance training protocols', 'familiarisation session and three resistance training protocols (i.e., TRAD, SS, and TRI', 'SS and TRI', 'traditional, superset, and tri-set resistance training structures']","['training efficiency and reduce training time', 'efficiency and rate of perceived exertion', 'lactate responses', 'SS and TRI', 'Rating of perceived exertion, lactate concentration ([Lac]), creatine kinase concentration ([CK]), countermovement jump (CMJ), testosterone, and cortisol concentrations']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",14.0,0.0201426,"TRAD and SS showed almost certain and likely decreases in cortisol immediately post, respectively, with TRAD reporting likely decreases at 24-h post-training. ","[{'ForeName': 'Jonathon J S', 'Initials': 'JJS', 'LastName': 'Weakley', 'Affiliation': 'Room G03, Macaulay Hall, Institute for Sport, Physical Activity and Leisure, Centre for Sports Performance, Headingley Campus, Leeds Beckett University, West Yorkshire, LS6 3GZ, UK. j.j.weakley@leedsbeckett.ac.uk.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Till', 'Affiliation': 'Room G03, Macaulay Hall, Institute for Sport, Physical Activity and Leisure, Centre for Sports Performance, Headingley Campus, Leeds Beckett University, West Yorkshire, LS6 3GZ, UK.'}, {'ForeName': 'Dale B', 'Initials': 'DB', 'LastName': 'Read', 'Affiliation': 'Room G03, Macaulay Hall, Institute for Sport, Physical Activity and Leisure, Centre for Sports Performance, Headingley Campus, Leeds Beckett University, West Yorkshire, LS6 3GZ, UK.'}, {'ForeName': 'Gregory A B', 'Initials': 'GAB', 'LastName': 'Roe', 'Affiliation': 'Room G03, Macaulay Hall, Institute for Sport, Physical Activity and Leisure, Centre for Sports Performance, Headingley Campus, Leeds Beckett University, West Yorkshire, LS6 3GZ, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Darrall-Jones', 'Affiliation': 'Room G03, Macaulay Hall, Institute for Sport, Physical Activity and Leisure, Centre for Sports Performance, Headingley Campus, Leeds Beckett University, West Yorkshire, LS6 3GZ, UK.'}, {'ForeName': 'Padraic J', 'Initials': 'PJ', 'LastName': 'Phibbs', 'Affiliation': 'Room G03, Macaulay Hall, Institute for Sport, Physical Activity and Leisure, Centre for Sports Performance, Headingley Campus, Leeds Beckett University, West Yorkshire, LS6 3GZ, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Room G03, Macaulay Hall, Institute for Sport, Physical Activity and Leisure, Centre for Sports Performance, Headingley Campus, Leeds Beckett University, West Yorkshire, LS6 3GZ, UK.'}]",European journal of applied physiology,['10.1007/s00421-017-3680-3'] 1371,31582358,"Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial.","BACKGROUND Since the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might have clinical benefit for patients with influenza infection, but definitive data do not exist. We aimed to evaluate the safety and efficacy of hIVIG in a randomised controlled trial. METHODS This randomised, double-blind, placebo-controlled trial was planned for 45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013-14 to 2017-18. Adults (≥18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned (1:1) to receive standard care plus either a single 500-mL infusion of high-titre hIVIG (0·25 g/kg bodyweight, 24·75 g maximum; hIVIG group) or saline placebo (placebo group). Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms began no more than 7 days before randomisation. Pregnant and breastfeeding women were excluded, as well as any patients for whom the treatment would present a health risk. Separate randomisation schedules were generated for each participating clinical site using permuted block randomisation. Treatment assignments were obtained using a web-based application by the site pharmacist who then masked the solution for infusion. Patients and investigators were masked to study treatment. The primary endpoint was a six-category ordinal outcome of clinical status at day 7, ranging in severity from death to resumption of normal activities after discharge. The choice of day 7 was based on haemagglutination inhibition titres from a pilot study. It was analysed with a proportional odds model, using all six categories to estimate a common odds ratio (OR). An OR greater than 1 indicated that, for a given category, patients in the hIVIG group were more likely to be in a better category than those in the placebo group. Prespecified primary analyses for safety and efficacy were based on patients who received an infusion and for whom eligibility could be confirmed. This trial is registered with ClinicalTrials.gov, NCT02287467. FINDINGS 313 patients were enrolled in 34 sites between Dec 11, 2014, and May 28, 2018. We also used data from 16 patients enrolled at seven of the 34 sites during the pilot study between Jan 15, 2014, and April 10, 2014. 168 patients were randomly assigned to the hIVIG group and 161 to the placebo group. 21 patients were excluded (12 from the hIVIG group and 9 from the placebo group) because they did not receive an infusion or their eligibility could not be confirmed. Thus, 308 were included in the primary analysis. hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres. Based on the proportional odds model, the OR on day 7 was 1·25 (95% CI 0·79-1·97; p=0·33). In subgroup analyses for the primary outcome, the OR in patients with influenza A was 0·94 (0·55-1·59) and was 3·19 (1·21-8·42) for those with influenza B (interaction p=0·023). Through 28 days of follow-up, 47 (30%) of 156 patients in the hIVIG group and in 45 (30%) of 152 patients in the placebo group had the composite safety outcome of death, a serious adverse event, or a grade 3 or 4 adverse event (hazard ratio [HR] 1·06, 95% CI 0·70-1·60; p=0·79). Six (4%) patients in the hIVIG group and five (3%) in the placebo group died, but these deaths were not necessarily related to treatment. INTERPRETATION When administered alongside standard care (most commonly oseltamivir), hIVIG was not superior to placebo for adults hospitalised with influenza infection. By contrast with our prespecified subgroup hypothesis that hIVIG would result in more favourable responses in patients with influenza A than B, we found the opposite effect. The clinical benefit of hIVIG for patients with influenza B is supported by antibody affinity analyses, but confirmation is warranted. FUNDING NIAID and NIH. Partial support was provided by the Medical Research Council (MRC_UU_12023/23) and the Danish National Research Foundation.",2019,hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres.,"['21 patients were excluded (12 from the hIVIG group and 9 from the', 'adults hospitalised with influenza infection', '313 patients were enrolled in 34 sites between Dec 11, 2014, and May 28, 2018', '45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013-14 to 2017-18', '16 patients enrolled at seven of the 34 sites during the pilot study between Jan 15, 2014, and April 10, 2014', 'Pregnant and breastfeeding women', 'patients with influenza B', 'adults with influenza A or B infection (FLU-IVIG', 'Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms began no more than 7 days before randomisation', 'patients with influenza infection', '168 patients', 'Adults (≥18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned ']","['placebo', 'saline placebo (placebo', 'Anti-influenza hyperimmune intravenous immunoglobulin', 'standard care plus either a single 500-mL infusion of high-titre hIVIG (0·25 g/kg bodyweight, 24·75']","['six-category ordinal outcome of clinical status at day 7, ranging in severity from death to resumption of normal activities', 'haemagglutination inhibition titres', 'safety and efficacy', 'composite safety outcome of death, a serious adverse event, or a grade 3 or 4 adverse event (hazard ratio [HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0249692', 'cui_str': 'human immunodeficiency virus hyperimmune globulin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0249692', 'cui_str': 'human immunodeficiency virus hyperimmune globulin'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",313.0,0.679544,hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres.,"[{'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. Electronic address: rdavey@niaid.nih.gov.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fernández-Cruz', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Servicio de Immunología Clínica, Madrid, Spain.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Markowitz', 'Affiliation': 'Henry Ford Hospital, Division of Infectious Diseases, Detroit, MI, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wentworth', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Surender', 'Initials': 'S', 'LastName': 'Khurana', 'Affiliation': 'Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Engen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Gordin', 'Affiliation': 'Veteran Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Kan', 'Affiliation': 'Veteran Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Polizzotto', 'Affiliation': 'The Kirby Institute, University of New South Wales Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Riska', 'Affiliation': 'Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; The HIV Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Zelalem', 'Initials': 'Z', 'LastName': 'Temesgen', 'Affiliation': 'Mayo Clinic Hospital, Saint Marys Campus, Rochester, MN, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'CHIP Centre of Excellence for Health, Immunity, and Infections, Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30253-X'] 1372,29967969,"A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections.","BACKGROUND Local hemostatic agents have a role in limiting bleeding complications associated with liver resection. METHODS In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T 4 ) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T 2 , T 3 , T 5 , T 7 , and T 10 . RESULTS The rate of hemostasis by T 4 was 92.8% in the FS Grifols group (n = 163) and 80.5% in the Surgicel® group (n = 162) (p = 0.01). The mean TTH was significantly shorter (p < 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by T 2 , T 5 , and T 7 was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%). CONCLUSIONS FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.",2018,"The rate of hemostasis by T 2 , T 5 , and T 7 was higher and statistically superior in the FS Grifols group compared to Surgicel®.",['Hepatic Surgery Resections'],"['Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®', 'Fibrin Sealant Grifols']","['safe and well tolerated', 'mean TTH', 'hypotension', 'time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis', 'adverse events (AE', 'procedural pain', 'rate of hemostasis', 'proportion of patients achieving hemostasis at target bleeding sites (TBS', 'nausea', 'efficacy and safety']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0007649', 'cui_str': 'Absorbable Cellulose'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C0075660', 'cui_str': 'Surgicel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0352819,"The rate of hemostasis by T 2 , T 5 , and T 7 was higher and statistically superior in the FS Grifols group compared to Surgicel®.","[{'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Bjelović', 'Affiliation': 'Department for Minimally Invasive Upper Digestive Surgery, Clinical Center of Serbia, Hospital for Digestive Surgery - First Surgical Hospital, Dr Koste Todorovica Street No 66, Belgrade, 11000, Serbia. milos.bjelovic@gmail.com.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Ayguasanosa', 'Affiliation': 'Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Robin D', 'Initials': 'RD', 'LastName': 'Kim', 'Affiliation': 'Division of Transplantation and Advanced Hepatobiliary Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Stojanović', 'Affiliation': 'HBP unit Clinical Center Niš, General Surgery Clinic, Niš, Serbia.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Vereczkei', 'Affiliation': 'Department of Surgery, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Nikolić', 'Affiliation': 'Clinic of Surgical Oncology, Institute of Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Winslow', 'Affiliation': 'Department of Surgery, University of Wisconsin Hospital and Clinics, Madison, WI, USA.'}, {'ForeName': 'Sukru', 'Initials': 'S', 'LastName': 'Emre', 'Affiliation': 'Department of Surgery: Transplant & Immunology, Yale-New Haven Hospital, New Haven, CT, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'Division of Multi-Organ Transplantation and Hepato-Pancreato-Biliary Surgery, Department of Surgery, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Navarro-Puerto', 'Affiliation': 'Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Kecia', 'Initials': 'K', 'LastName': 'Courtney', 'Affiliation': 'Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': 'Gladis', 'Initials': 'G', 'LastName': 'Barrera', 'Affiliation': 'Bioscience Research Group, Grifols, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-018-3852-4'] 1373,31584525,Successful Treatment of Multiple Common Warts With Intralesional Ozone.,"BACKGROUND Although there are multiple treatments for warts, wart management remains a challenge. Ozone therapy is an emerging treatment for infectious and noninfectious dermatological diseases. OBJECTIVE To assess intralesional ozone gas safety and efficacy in multiple warts management. MATERIALS AND METHODS Seventy-four adult patients with multiple common warts were included in this study. They were randomly assigned into 2 groups: first group comprised 44 patients treated with intralesional ozone gas, and the second group comprised 30 patients who received intralesional saline injection. In both groups, warts in all patients were directly injected weekly until complete clearance occurred or for a maximum of 10 treatment sessions. The subjects were followed for 6 months to record any recurrences. RESULTS In the ozone group, 25 patients (56.8%) had a complete response with an excellent cosmetic outcome, 15 patients (34.1%) showed a partial response, and 4 patients (9.1%) had no response. More subjects responded to ozone than to saline (p < .001). Ozone therapy was associated with mild side effects, including pain at time of injection, numbness, and fatigue. CONCLUSION Intralesional ozone is effective and safe for the treatment of multiple warts.",2020,More subjects responded to ozone than to saline (p < .001).,['Seventy-four adult patients with multiple common warts were included in this study'],"['intralesional ozone gas', 'Intralesional Ozone', 'intralesional saline injection', 'Ozone therapy']","['complete response with an excellent cosmetic outcome', 'mild side effects, including pain at time of injection, numbness, and fatigue', 'partial response']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0043037', 'cui_str': 'Verruca vulgaris (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",74.0,0.0479414,More subjects responded to ozone than to saline (p < .001).,"[{'ForeName': 'Alshimaa M', 'Initials': 'AM', 'LastName': 'Ibrahim', 'Affiliation': '*All authors are affiliated with the Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Reham A', 'Initials': 'RA', 'LastName': 'Elkot', 'Affiliation': ''}, {'ForeName': 'Shrook A', 'Initials': 'SA', 'LastName': 'Khashaba', 'Affiliation': 'All authors are affiliated with the Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002174'] 1374,31138728,"Resistance Training With Elastic Tubing Improves Muscle Strength, Exercise Capacity, and Post-Exercise Creatine Kinase Clearance in Subjects With COPD.","BACKGROUND Among the types of physical exercise, resistance exercises have been gaining significant attention in the COPD population. The aim of this study was to compare effects of conventional resistance training and of training by using elastic tubes on muscle strength, exercise capacity, and creatine kinase clearance in subjects with COPD. METHODS Twenty-eight subjects with COPD were randomized into the following: resistance training with the elastic tubing group and resistance training with the weight-machine training group (conventional resistance group), performed 3 times a week for 12 weeks. The subjects were submitted to spirometry, functional exercise capacity (the 6-min walk test), muscle strength (dynamometry), and the repetition maximum test. Differences between the initial and final evaluations (Δ) and the (final - initial evaluations)/initial evaluations ×100 (Δ%) of each group were expressed as mean [95% CI]. RESULTS Nineteen subjects (FEV 1 % predicted, 52 ± 18; years, 65 ± 8) completed the training program. Similar improvements were observed in both modalities on muscle strength (knee extension, Δ%18 [6 to 29]; knee flexion, Δ%35 [17 to 54]; elbow flexion, Δ%28 [9 to 48]; shoulder abduction, Δ%41 [25 to 58] and shoulder flexion, Δ%31 [11 to 51] in the weight-machine training group (conventional resistance group); knee extension, Δ%15 [8 to 21]; knee flexion, Δ%28 [15 to 41]; elbow flexion, Δ%36 [22 to 51]; and shoulder abduction, Δ%43 [32 to 55] and shoulder flexion, Δ%43 [25 to 61] in the elastic tubing group, P < .05 for intra-group analysis and P > .05 for between groups analysis), 6-min walk test (baseline 493 ± 67m vs 12 weeks 526 ± 78 in the weight-machine training group ( P = .10); baseline 493 ± 71 vs 12 weeks 524 ± 68 in the elastic tubing group ( P < .01), P = .88 between groups). The elastic tubing group had lower accumulated creatine kinase levels between 24 and 72 h ((Δ%-24 [-31 to 16] than subjects in the weight-machine training group Δ%3 [-21 to 28], P = .042 between the groups. CONCLUSIONS Training with elastic resistance provided similar changes in muscle strength and exercise capacity to conventional resistance group in the subjects with COPD. The elastic tubing group had faster creatine kinase clearance after a training session than the weight-machine training group (conventional resistance group). The ease of its application associated with similar training benefits to conventional training supported its application in clinical routine.",2019,The elastic tubing group had faster creatine kinase clearance after a training session than the weight-machine training group (conventional resistance group).,"['Twenty-eight subjects with COPD', 'Subjects With COPD', 'subjects with COPD', '9 to 48]; shoulder abduction, Δ%41 [25 to 58] and shoulder flexion, Δ%31 [11 to 51] in the weight-machine training group (conventional resistance group); knee extension, Δ%15 [8 to 21]; knee flexion, Δ%28', 'Nineteen subjects (FEV 1 % predicted, 52 ± 18; years, 65 ± 8) completed the training program']","['resistance training with the elastic tubing group and resistance training with the weight-machine training group (conventional resistance group', 'physical exercise, resistance exercises', 'conventional resistance training and of training by using elastic tubes']","['muscle strength and exercise capacity', '6-min walk test', 'muscle strength', 'creatine kinase levels', 'Muscle Strength, Exercise Capacity, and Post-Exercise Creatine Kinase Clearance', 'muscle strength, exercise capacity, and creatine kinase clearance', 'creatine kinase clearance', 'shoulder flexion']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184165', 'cui_str': 'Tubing (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0750863', 'cui_str': 'Finding of creatine kinase level'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",28.0,0.0344015,The elastic tubing group had faster creatine kinase clearance after a training session than the weight-machine training group (conventional resistance group).,"[{'ForeName': 'Bruna Sa', 'Initials': 'BS', 'LastName': 'Silva', 'Affiliation': 'Skeletal Muscle Assessment Laboratory, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Dionei', 'Initials': 'D', 'LastName': 'Ramos', 'Affiliation': 'Department of Physical Therapy, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camillo', 'Affiliation': 'University of Londrina, Department of Physiotherapy, Londrina, Paraná, Brazil and University Pitágoras UNOPAR, Departmentt of Rehabilitation Sciences, Londrina, Paraná, Brazil.'}, {'ForeName': 'Iara B', 'Initials': 'IB', 'LastName': 'Trevisan', 'Affiliation': 'Department of Physical Therapy, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Giovanna A', 'Initials': 'GA', 'LastName': 'Arévalo', 'Affiliation': 'Department of Physical Therapy, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Ana Paula Cf', 'Initials': 'APC', 'LastName': 'Freire', 'Affiliation': 'Department of Physical Therapy, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Marceli R', 'Initials': 'MR', 'LastName': 'Leite', 'Affiliation': 'Department of Physical Therapy, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Fabiano F', 'Initials': 'FF', 'LastName': 'de Lima', 'Affiliation': 'Department of Physical Therapy, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Gobbo', 'Affiliation': 'Skeletal Muscle Assessment Laboratory, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Ercy Mc', 'Initials': 'EM', 'LastName': 'Ramos', 'Affiliation': 'Department of Physical Therapy, São Paulo State University (UNESP), Presidente Prudente, São Paulo, Brazil. ercy@bol.com.br.'}]",Respiratory care,['10.4187/respcare.05975'] 1375,32412358,A Randomized Placebo Controlled Clinical Trial Demonstrating Safety & Efficacy of EnXtra ® in Healthy Adults.,"Objective: The present randomized, placebo-controlled study aimed to assess the long-term safety and perceivable mental acuity benefits of EnXtra ® in healthy individuals. Methods: Study participants were administered EnXtra ® with or without caffeine for a period of 12 weeks. The cardiovascular safety was evaluated by assessing change in QT interval, blood pressure and heart rate. Further, other efficacy variables evaluated were change in perceived alertness and calmness by Bond and Lader mood scales, Sleep disturbance by Pittsburgh sleep quality Index and daytime sleepiness by Epworth sleepiness scale. Results: None of the study group showed any significant change in the ECG or haemodynamic parameters as compared to baseline (p > 0.05). Post consumption, alertness and calmness scores were significantly increased in the EnXtra ® , and EnXtra ® plus caffeine group (p < 0.001) as compared to placebo. Daytime sleep scores decreased in the EnXtra ® group however change was not significant. Sleep quality remained undisturbed in all three arms. Conclusion: The findings demonstrated the psychostimulant efficacy of EnXtra ® with no safety concerns on long-term usage.",2020,"Post consumption, alertness and calmness scores were significantly increased in the EnXtra ® , and EnXtra ® plus caffeine group (p < 0.001) as compared to placebo.","['Healthy Adults', 'healthy individuals']","['EnXtra ®', 'Placebo', 'EnXtra ® with or without caffeine', 'placebo']","['perceived alertness and calmness by Bond and Lader mood scales, Sleep disturbance by Pittsburgh sleep quality Index and daytime sleepiness by Epworth sleepiness scale', 'QT interval, blood pressure and heart rate', 'Sleep quality', 'Daytime sleep scores', 'Post consumption, alertness and calmness scores', 'cardiovascular safety', 'ECG or haemodynamic parameters']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.181249,"Post consumption, alertness and calmness scores were significantly increased in the EnXtra ® , and EnXtra ® plus caffeine group (p < 0.001) as compared to placebo.","[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Department of Clinical development, Enovate Biolife, Mumbai, Maharashtra, India.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mennemeier', 'Affiliation': 'Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Jayesh Anand', 'Initials': 'JA', 'LastName': 'Chaudhary', 'Affiliation': 'Vedic Lifesciences, Mumbai, Maharashtra, India.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1753129'] 1376,31444917,"Effects of poloxamer-based thermo-sensitive sol-gel agent on urethral stricture after transurethral resection of the prostate for benign prostatic hyperplasia: a multicentre, single-blinded, randomised controlled trial.","OBJECTIVE To evaluate the effectiveness of poloxamer-based thermo-sensitive sol-gel instillation, after transurethral resection of the prostate (TURP), for preventing urethral stricture. PATIENTS AND METHODS In all, 198 patients underwent TURP for benign prostatic hyperplasia. Recruited patients were randomly divided into two groups: groups A and B. Patients in Group A (100 patients, experimental group) received poloxamer-based thermo-sensitive sol-gel instillation and patients in the Group B (98 patients, control group) received lubricant instillation after TURP. Each patient was evaluated at 4 (V1), 12 (V2), and 24 weeks (V3) after TURP. The effectiveness of poloxamer-based thermo-sensitive sol-gel instillation was evaluated based on the International Prostate Symptom Score (IPSS), IPSS-Quality of Life (QoL), Overactive bladder questionnaire (OAB-q), maximum urinary flow rate (Q max ), post-void residual urine volume (PVR), and cystoscopy. RESULTS Amongst the initial 198 participants, 80 patients in Group A and 83 in Group B completed the study. There were no significant differences in IPSS-QoL and OAB-q between the groups. However, Q max was significantly different between groups A and B, at a mean (SD) of 18.92 (9.98) vs 15.58 (9.24) mL/s (P = 0.028) at 24 weeks after TURP. On cystoscopic examination, urethral stricture after TURP was found in two of the 80 patients in Group A and 10 of 83 in Group B (P = 0.023). CONCLUSIONS Poloxamer-based thermo-sensitive sol-gel instillation after TURP lowered the incidence of urethral stricture.",2020,There were no significant differences in IPSS-QoL and OAB-q between groups.,"['urethral stricture after transurethral resections of the prostate for benign prostatic hyperplasia', '198 initial participants, 80 patients in group A and 83 patients in group B had completed the experiment', '198 patients underwent TURP for benign prostatic hyperplasia']","['poloxamer-based thermo-sensitive sol-gel', 'lubricant instillation after TURP', 'poloxamer-based thermo-sensitive sol-gel instillation', 'poloxamer-based thermo-sensitive sol-gel instillation after transurethral resection of the prostate (TURP']","['International Prostate Symptom Score (IPSS)-Quality of Life (QoL), Overactive bladder questionnaire (OAB-q), peak urine flow rate (Qmax), postvoid residual volume (PVR), and cystoscopy', 'IPSS-QoL and OAB-q', 'cystoscopic examination, urethral stricture after TURP', 'incidence of urethral stricture']","[{'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0086827', 'cui_str': 'Poloxamers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0701413', 'cui_str': 'Sol'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",198.0,0.0269043,There were no significant differences in IPSS-QoL and OAB-q between groups.,"[{'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyu Shik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Duck', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'Department of Urology, Eulji Medical Center, Eulji University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Tae Hyo', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Departments of Urology, College of Medicine, Dong-A University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Ki Soo', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Departments of Urology, College of Medicine, Dong-A University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Cheol Young', 'Initials': 'CY', 'LastName': 'Oh', 'Affiliation': 'Department of Urology, Hallym University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joon Hwa', 'Initials': 'JH', 'LastName': 'Noh', 'Affiliation': 'Department of Urology, Kwangju Christian Hospital, Gwangju, South Korea.'}, {'ForeName': 'Jun Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Kwangju Christian Hospital, Gwangju, South Korea.'}, {'ForeName': 'Won Tae', 'Initials': 'WT', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, College of Medicine, Chungbuk National University, Cheongju, South Korea.'}, {'ForeName': 'Seung Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Heon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Tae Nam', 'Initials': 'TN', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Huh', 'Affiliation': 'Daewoong Pharmaceutical Co. Ltd, Seoul, South Korea.'}, {'ForeName': 'Seung Wook', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hanyang University College of Medicine, Seoul, South Korea.'}]",BJU international,['10.1111/bju.14902'] 1377,30281073,Randomised study demonstrates sustained benefits of a pre-school intervention designed to improve nutrition and physical activity practices.,"BACKGROUND Health-promoting programmes must demonstrate sustained efficacy in order to make a true impact on public health. This study aimed to determine the effect of the Healthy Incentive for Pre-schools project on health-promoting practices in full-day-care pre-schools 18 months after a training intervention. METHODS Thirty-seven pre-schools completed the initial study and were included in this follow-up study. The intervention consisted of one training session with either the pre-school 'manager-only' or 'manager and staff' using a specifically developed needs-based training resource pack comprised of written educational material and a validated health-promoting practice evaluation tool. Direct observation data of health-promoting practices were collected and allocated a score using the evaluation tool by a research dietitian at three time points; pre-intervention, between 6 and 9 months post-intervention and at 18-month follow-up. An award system was used to incentivise pre-schools to improve their scores. RESULTS Health-promoting practice scores improved significantly (P < 0.001) from the 6-9 month post-intervention to the 18-month follow-up evaluation. No significant differences were observed between 'manager-only' and 'manager and staff' trained pre-schools. CONCLUSIONS The introduction of a pre-school evaluation tool supported by a training resource was successfully used to incentivise pre-schools to sustain and improve health-promoting practices 18 months after intervention training.",2019,"Results Health-promoting practice scores improved significantly (P < 0.001) from the 6-9 month post-intervention to the 18-month follow-up evaluation.","['Methods\n\n\nThirty-seven pre-schools completed the initial study and were included in this follow-up study', 'Healthy Incentive for Pre-schools project on health-promoting practices in full-day-care pre-schools 18 months after a training intervention']","['pre-school intervention', ""one training session with either the pre-school 'manager-only' or 'manager and staff' using a specifically developed needs-based training resource pack comprised of written educational material and a validated health-promoting practice evaluation tool""]","[""manager-only' and 'manager and staff' trained pre-schools.\nConclusions"", 'Results\n\n\nHealth-promoting practice scores']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0288204,"Results Health-promoting practice scores improved significantly (P < 0.001) from the 6-9 month post-intervention to the 18-month follow-up evaluation.","[{'ForeName': 'Diewerke', 'Initials': 'D', 'LastName': 'de Zwarte', 'Affiliation': 'School of Biological Sciences, Dublin Institute of Technology, Dublin 8, Republic of Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kearney', 'Affiliation': 'School of Biological Sciences, Dublin Institute of Technology, Dublin 8, Republic of Ireland.'}, {'ForeName': 'Clare A', 'Initials': 'CA', 'LastName': 'Corish', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Glennon', 'Affiliation': ""Community Nutrition and Dietetic Service, Health Service Executive Dublin Mid-Leinster, Primary Care Unit, St. Loman's Hospital Campus, Co. Westmeath, Republic of Ireland.""}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Maher', 'Affiliation': ""Community Nutrition and Dietetic Service, Health Service Executive Dublin Mid-Leinster, Primary Care Unit, St. Loman's Hospital Campus, Co. Westmeath, Republic of Ireland.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Johnston Molloy', 'Affiliation': ""Community Nutrition and Dietetic Service, Health Service Executive Dublin Mid-Leinster, Primary Care Unit, St. Loman's Hospital Campus, Co. Westmeath, Republic of Ireland.""}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdy173'] 1378,30115425,Comparison of Frequency of Atherosclerotic Cardiovascular and Safety Events With Systolic Blood Pressure <120mm Hg Versus 135-139mm Hg in a Systolic Blood Pressure Intervention Trial Primary Prevention Subgroup.,"Whether the benefit of intensive blood pressure (BP) control reduces atherosclerotic cardiovascular disease (ASCVD) risk without increasing risks of serious adverse events (SAEs) is unknown. We sought to assess differences in incident ASCVD and SAE with intensive BP control across the spectrum of 10-year ASCVD risk in the Systolic Blood Pressure Intervention Trial (SPRINT). SPRINT randomized 9,361 participants who were ≥50years old and ≥1 CVD risk factor to standard or intensive BP control (<120 or 130 to 139mm Hg). We excluded adults with clinical ASCVD or age ≥80. We included 6,875 participants. We compared hazard ratios (HR) and risk differences (RD) of incident ASCVD events or SAEs in all and across quartiles of baseline risk. Median predicted ASCVD risk was 15.9%. Intensive BP control significantly reduced ASCVD events (HR 0.75, 95% confidence interval 0.58, 0.97, p = 0.03; RD -0.94; -1.8, -0.1; p = 0.03). There was no difference in effect across quartiles of ASCVD risk. There was a non-significant increase in SAE with intensive BP control (HR 1.08, 1.00, 1.17 p = 0.06; RD 2.1, -0.1, 4.4, p = 0.03), and no difference in this effect across quartiles of risk. In SPRINT participants without baseline clinical ASCVD, the benefit of intensive BP control for primary prevention of ASCVD may extend to lower risk participants without an increase in SAE. In conclusion, lower risk adults with stage 1 hypertension meeting SPRINT eligibility may benefit from initiation of antihypertensives.",2018,"Intensive BP control significantly reduced ASCVD events (HR 0.75, 95% confidence interval 0.58, 0.97, p = 0.03; RD -0.94; -1.8, -0.1; p = 0.03).","['adults with clinical ASCVD or age ≥80', '6,875 participants', '9,361 participants who were ≥50years old and ≥1 CVD risk factor to standard or intensive BP control (<120 or 130 to 139mm Hg', '135-139mm Hg in a Systolic Blood Pressure Intervention Trial Primary Prevention Subgroup']","['Systolic Blood Pressure', 'intensive blood pressure (BP) control']","['ASCVD events', 'hazard ratios (HR) and risk differences (RD) of incident ASCVD events or SAEs', 'SAE with intensive BP control', 'Median predicted ASCVD risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",9361.0,0.260396,"Intensive BP control significantly reduced ASCVD events (HR 0.75, 95% confidence interval 0.58, 0.97, p = 0.03; RD -0.94; -1.8, -0.1; p = 0.03).","[{'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont. Electronic address: Timothy.Plante@uvm.edu.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts; Division of General Internal Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Welch Center for Prevention, Epidemiology, and Clinical Research, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Division of General Internal Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Welch Center for Prevention, Epidemiology, and Clinical Research, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Division of General Internal Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Welch Center for Prevention, Epidemiology, and Clinical Research, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cushman', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont; Department of Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Littenberg', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}]",The American journal of cardiology,['10.1016/j.amjcard.2018.06.041'] 1379,28871440,"Triheptanoin versus trioctanoin for long-chain fatty acid oxidation disorders: a double blinded, randomized controlled trial.","BACKGROUND Observational reports suggest that supplementation that increases citric acid cycle intermediates via anaplerosis may have therapeutic advantages over traditional medium-chain triglyceride (MCT) treatment of long-chain fatty acid oxidation disorders (LC-FAODs) but controlled trials have not been reported. The goal of our study was to compare the effects of triheptanoin (C7), an anaplerotic seven-carbon fatty acid triglyceride, to trioctanoin (C8), an eight-carbon fatty acid triglyceride, in patients with LC-FAODs. METHODS A double blinded, randomized controlled trial of 32 subjects with LC-FAODs (carnitine palmitoyltransferase-2, very long-chain acylCoA dehydrogenase, trifunctional protein or long-chain 3-hydroxy acylCoA dehydrogenase deficiencies) who were randomly assigned a diet containing 20% of their total daily energy from either C7 or C8 for 4 months was conducted. Primary outcomes included changes in total energy expenditure (TEE), cardiac function by echocardiogram, exercise tolerance, and phosphocreatine recovery following acute exercise. Secondary outcomes included body composition, blood biomarkers, and adverse events, including incidence of rhabdomyolysis. RESULTS Patients in the C7 group increased left ventricular (LV) ejection fraction by 7.4% (p = 0.046) while experiencing a 20% (p = 0.041) decrease in LV wall mass on their resting echocardiogram. They also required a lower heart rate for the same amount of work during a moderate-intensity exercise stress test when compared to patients taking C8. There was no difference in TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis, or any secondary outcome measures between the groups. CONCLUSIONS C7 improved LV ejection fraction and reduced LV mass at rest, as well as lowering heart rate during exercise among patients with LC-FAODs. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov NCT01379625.",2017,"There was no difference in TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis, or any secondary outcome measures between the groups. ","['patients with LC-FAODs', '32 subjects with LC-FAODs (carnitine palmitoyltransferase-2, very long-chain acylCoA dehydrogenase, trifunctional protein or long-chain 3-hydroxy acylCoA dehydrogenase deficiencies']","['Triheptanoin versus trioctanoin', 'triheptanoin (C7), an anaplerotic seven-carbon fatty acid triglyceride, to trioctanoin (C8', 'diet containing 20% of their total daily energy from either C7 or C8']","['left ventricular (LV) ejection fraction', 'heart rate', 'lowering heart rate', 'TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis', 'LV ejection fraction and reduced LV mass', 'body composition, blood biomarkers, and adverse events, including incidence of rhabdomyolysis', 'LV wall mass on their resting echocardiogram', 'changes in total energy expenditure (TEE), cardiac function by echocardiogram, exercise tolerance, and phosphocreatine recovery following acute exercise']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007262', 'cui_str': 'Carnitine Acyltransferase I'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0077030', 'cui_str': 'glycerol tricaprylate'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]",32.0,0.635348,"There was no difference in TEE, phosphocreatine recovery, body composition, incidence of rhabdomyolysis, or any secondary outcome measures between the groups. ","[{'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'Gillingham', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA. gillingm@ohsu.edu.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': ""Neurogenetics and Metabolism, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.""}, {'ForeName': 'Areeg Hassan', 'Initials': 'AH', 'LastName': 'El-Gharbawy', 'Affiliation': ""Division of Medical Genetics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Deward', 'Affiliation': ""Division of Medical Genetics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Lasarev', 'Affiliation': 'Center for Research on Occupational and Environmental Toxicology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Pollaro', 'Affiliation': 'Advanced Imaging Research Center, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'DeLany', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Burchill', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Goodpaster', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shoemaker', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Saint Louis University, Saint Louis, MO, USA.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Matern', 'Affiliation': 'Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Graduate Programs in Human Nutrition, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""Division of Medical Genetics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}]",Journal of inherited metabolic disease,['10.1007/s10545-017-0085-8'] 1380,31075722,A controlled study of the efficacy and safety of tandospirone citrate combined with escitalopram in the treatment of vascular depression: A pilot randomized controlled trial at a single-center in China.,"Vascular depression can respond poorly to antidepressants. This study aimed to explore the efficacy and safety of tandospirone plus escitalopram for treating vascular depression with anxiety. This pilot randomized controlled trial included consecutive inpatients/outpatients with vascular depression/anxiety at the Department of Neurology, Fujian Medical University Union Hospital, China (January 2014 to December 2016). Among 157 patients screened, 100 were randomly divided into the tandospirone + escitalopram (combination therapy) and escitalopram (monotherapy) groups equally, and then followed for 8 weeks. Efficacy was evaluated using the Hamilton Depression (HAMD), Hamilton Anxiety (HAMA), Clinical Global Impression (CGI) and Mini-Mental State examination (MMSE) scales. Adverse events (AEs) were assessed with the Treatment Emergent Symptom Scale (TESS). HAMD and HAMA scores decreased progressively, showing reductions versus baseline at 1, 2, 4 and 8 weeks in both groups (P < 0.001). HAMD and HAMA scores were lower in the tandospirone + escitalopram group than those in the escitalopram group at 1 and 2 weeks (P < 0.001), but not at 4 and 8 weeks. Improvements in CGI scores (severity, improvement and efficacy indexes) were greater in the tandospirone + escitalopram group than that in the escitalopram group at 1 and 2 weeks (P < 0.01), but not at 4 and 8 weeks. The tandospirone + escitalopram group had higher MMSE scores than that in the escitalopram group at 4 and 8 weeks (P < 0.01). All AEs were mild, and the rates were comparable between groups. Augmentation of escitalopram with tandospirone accelerates the onset of anti-depressive and anxiolytic effects and improves cognitive function in patients with vascular depression and anxiety.",2019,"Improvements in CGI scores (severity, improvement and efficacy indexes) were greater in the tandospirone + escitalopram group than that in the escitalopram group at 1 and 2 weeks (P < 0.01), but not at 4 and 8 weeks.","['patients with vascular depression and anxiety', '157 patients screened, 100 were randomly divided into the', 'vascular depression', 'consecutive inpatients/outpatients with vascular depression/anxiety at the Department of Neurology, Fujian Medical University Union Hospital, China (January 2014 to December 2016']","['tandospirone citrate combined with escitalopram', 'tandospirone\xa0+\xa0escitalopram (combination therapy) and escitalopram (monotherapy', 'tandospirone', 'tandospirone plus escitalopram']","['Efficacy', 'cognitive function', 'Hamilton Depression (HAMD), Hamilton Anxiety (HAMA), Clinical Global Impression (CGI) and Mini-Mental State examination (MMSE) scales', 'HAMD and HAMA scores', 'Vascular depression', 'Treatment Emergent Symptom Scale (TESS', 'MMSE scores', 'efficacy and safety', 'Adverse events (AEs', 'CGI scores (severity, improvement and efficacy indexes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0074676', 'cui_str': 'tandospirone'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",100.0,0.0652773,"Improvements in CGI scores (severity, improvement and efficacy indexes) were greater in the tandospirone + escitalopram group than that in the escitalopram group at 1 and 2 weeks (P < 0.01), but not at 4 and 8 weeks.","[{'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Qianwen', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Yongsen', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China. Electronic address: m13365910685@163.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.024'] 1381,31828490,Effects of an exercise-based oncology rehabilitation program and age on strength and physical function in cancer survivors.,"PURPOSE Cancer therapy diminishes strength and physical function in cancer survivors. Whether oncology rehabilitation (OR) exercise training following therapy can correct these deficits, and whether its effectiveness differs by age, is not clear. We examine the utility of a clinically based, 12-week, combined aerobic and resistance training intervention on muscle strength and physical function in two age groups of cancer survivors. METHODS Strength and physical function measures were assessed in middle-aged (45 to 64 years) and older (≥ 65 years) patients following treatment for stage 0-III cancer before and after the OR training program. RESULTS Older patients had lower physical function compared to middle-aged patients across a range of subjective and objective measures at baseline, and exercise improved all indices of physical function and strength in both age groups. Compared to the middle-aged individuals, older participants tended to have less improvement leg strength and the 5 time sit to stand (5TSTS) test as a result of OR. In models predicting post-intervention measures, older age contributed to less improvement in walking distance and power as well as the 5TSTS test. CONCLUSION Prior to beginning the OR exercise program, middle-aged patients had higher physical function compared to older patients. However, a 12-week aerobic and resistance training intervention improved physical function across both age groups, although older age did limit responsiveness in some physical function measures. The physical function and strength of middle-aged and older cancer survivors improve in response to an exercise-based OR program after cancer treatment.",2020,"RESULTS Older patients had lower physical function compared to middle-aged patients across a range of subjective and objective measures at baseline, and exercise improved all indices of physical function and strength in both age groups.","['cancer survivors', 'Older patients', 'middle-aged and older cancer survivors', 'middle-aged (45 to 64 years) and older (≥ 65 years', 'two age groups of cancer survivors']","['aerobic and resistance training intervention', 'oncology rehabilitation (OR) exercise training', 'combined aerobic and resistance training intervention', 'exercise-based oncology rehabilitation program', 'exercise-based OR program']","['muscle strength and physical function', 'physical function and strength', 'physical function', 'improvement leg strength', 'walking distance and power as well as the 5TSTS test', 'strength and physical function']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.015497,"RESULTS Older patients had lower physical function compared to middle-aged patients across a range of subjective and objective measures at baseline, and exercise improved all indices of physical function and strength in both age groups.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'Department of Internal Medicine, Vermont Center on Behavior and Health, University of Vermont, Given E-214, 89 Beaumont Ave, Burlington, VT, 05405, USA. kim.dittus@vtmednet.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Toth', 'Affiliation': 'Departments of Internal Medicine and Molecular Physiology and Biophysics, College of Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Priest', 'Affiliation': 'Medical Biostatistics Unit, University of Vermont, Burlington, VT, 05405, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Internal Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kokinda', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ades', 'Affiliation': 'Department of Internal Medicine, Vermont Center on Behavior and Health, University of Vermont, Given E-214, 89 Beaumont Ave, Burlington, VT, 05405, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05163-8'] 1382,32412597,"Snacking on whole almonds for 6 weeks improves endothelial function and lowers LDL cholesterol but does not affect liver fat and other cardiometabolic risk factors in healthy adults: the ATTIS study, a randomized controlled trial.","BACKGROUND There is convincing evidence that daily whole almond consumption lowers blood LDL cholesterol concentrations, but effects on other cardiometabolic risk factors such as endothelial function and liver fat are still to be determined. OBJECTIVES We aimed to investigate whether isoenergetic substitution of whole almonds for control snacks with the macronutrient profile of average snack intakes, had any impact on markers of cardiometabolic health in adults aged 30-70 y at above-average risk of cardiovascular disease (CVD). METHODS The study was a 6-wk randomized controlled, parallel-arm trial. Following a 2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n = 51) or control snacks (n = 56), providing 20% of daily estimated energy requirements. Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy), and secondary outcomes as markers of cardiometabolic disease risk were assessed at baseline and end point. RESULTS Almonds, compared with control, increased endothelium-dependent vasodilation (mean difference 4.1%-units of measurement; 95% CI: 2.2, 5.9), but there were no differences in liver fat between groups. Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability. However, the long-phase heart rate variability parameter, very-low-frequency power, was increased during nighttime following the almond treatment compared with control (mean difference 337 ms2; 95% CI: 12, 661), indicating greater parasympathetic regulation. CONCLUSIONS Whole almonds consumed as snacks markedly improve endothelial function, in addition to lowering LDL cholesterol, in adults with above-average risk of CVD.This trial was registered at clinicaltrials.gov as NCT02907684.",2020,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","['adults aged 30-70 y at above-average risk of cardiovascular disease (CVD', 'healthy adults']","['2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n\xa0=\xa051) or control snacks']","['liver fat', 'endothelial function', 'cardiometabolic health', 'blood LDL cholesterol concentrations', 'liver fat and other cardiometabolic risk factors', 'endothelial function and lowers LDL cholesterol', 'Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy', 'cardiometabolic disease risk', 'triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability', 'endothelium-dependent vasodilation', 'Plasma LDL cholesterol concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0452660', 'cui_str': 'Muffin'}, {'cui': 'C0440286', 'cui_str': 'Almond'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",,0.564696,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Dikariyanto', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Francis', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Eslem', 'Initials': 'E', 'LastName': 'Kusaslan', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Callaghan-Latham"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Palanche', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Annibale"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Christodoulou', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Basty', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Whitcher', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Shuaib', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Charles-Edwards', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Chowienczyk', 'Affiliation': ""Department of Clinical Pharmacology, School of Cardiovascular Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ellis', 'Affiliation': ""Biopolymers Group, Departments of Biochemistry and Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sarah E E', 'Initials': 'SEE', 'LastName': 'Berry', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa100'] 1383,31488360,"Health-related quality of life and neurocognitive functioning with lomustine-temozolomide versus temozolomide in patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09): a randomised, multicentre, open-label, phase 3 trial.","BACKGROUND The CeTeG/NOA-09 trial showed significantly longer overall survival with combined lomustine-temozolomide therapy compared with standard temozolomide for patients with glioblastoma with methylated MGMT promoter. The trial also aimed to investigate the effect of lomustine-temozolomide therapy on health-related quality of life (HRQOL) and neurocognitive function, which we report here. METHODS In this randomised, multicentre, open-label, phase 3 trial, newly diagnosed, chemoradiotherapy-naive patients with MGMT-methylated glioblastoma, aged 18-70 years, with a Karnofsky performance score of 70% or higher, were recruited and enrolled at 17 university hospitals in Germany. Patients received standard radiotherapy (60 Gy) and were randomly assigned (1:1, stratified by centre by allocating complete blocks of six to a centre, without masking) to either six 6-week courses of oral combined lomustine (100 mg/m 2 on day 1) plus temozolomide (100-200 mg/m 2 on days 2-6) or standard oral temozolomide (75 mg/m 2 daily during radiotherapy plus six 4-week courses of temozolomide [150-200 mg/m 2 ] on days 1-5, every 4 weeks). The primary endpoint was overall survival. HRQOL, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 and the EORTC brain cancer module (BN20); and neurocognitive function, assessed using the Mini Mental State Examination (MMSE), plus a neurocognitive test battery (NOA-07), including Trail Making Test A and B (TMT-A and B), working memory tests, and tests for lexical (Controlled Oral Word Association [COWA]) and semantic verbal fluency, were secondary endpoints analysed in the modified intention-to-treat population (mITT; all randomly assigned patients who received at least one dose of study chemotherapy). We used linear mixed-model analyses to investigate differences between treatment groups regarding HRQOL (clinically relevant ≥10 points) and MMSE scores (clinically relevant ≥3 points). The trial is registered with ClinicalTrials.gov, NCT01149109. FINDINGS Between June 17, 2011 and April 8, 2014, 141 patients were randomly assigned and 129 patients began treatment and were included in the mITT population (63 in the temozolomide and 66 in the lomustine-temozolomide group). Median follow-up for HRQOL (the item global health) was 19·4 months (IQR 7·8-38·6), for MMSE was 15·3 months (4·1-29·6), and for COWA was 11·0 months (0-27·5). We found no significant impairment regarding any item of HRQOL in the lomustine-temozolomide group (difference between the groups for global health 0·30 [95% CI -0·23 to 0·83]; p=0·26). Differences in MMSE were in favour of the temozolomide group (difference -0·11 [95% CI -0·19 to -0·03]; p=0·0058) but were not clinically relevant (1·76/30 points over 4 years). We found no significant difference between the groups in any subtest of the neurocognitive test battery (difference for COWA 0·04 [95% CI -0·01 to 0·09]; p=0·14). INTERPRETATION The absence of systematic and clinically relevant changes in HRQOL and neurocognitive function combined with the survival benefit of lomustine-temozolomide versus temozolomide alone suggests that a long-term net clinical benefit exists for patients with newly diagnosed glioblastoma with methylation of the MGMT promoter and supports the use of lomustine-temozolomide as a treatment option for these patients. FUNDING German Federal Ministry of Education and Research.",2019,We found no significant impairment regarding any item of HRQOL in the lomustine-temozolomide group (difference between the groups for global health 0·30,"['patients with glioblastoma with methylated MGMT promoter', 'Between June 17, 2011 and April 8, 2014, 141 patients were randomly assigned and 129 patients began treatment and were included in the mITT population (63 in the', 'newly diagnosed, chemoradiotherapy-naive patients with MGMT-methylated glioblastoma, aged 18-70 years, with a Karnofsky performance score of 70% or higher, were recruited and enrolled at 17 university hospitals in Germany', 'patients with newly diagnosed glioblastoma with methylation of the MGMT promoter', 'patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09', 'group']","['temozolomide', 'standard temozolomide', 'standard oral temozolomide', 'oral combined lomustine', 'lomustine-temozolomide versus temozolomide', 'lomustine-temozolomide therapy', 'lomustine-temozolomide', 'standard radiotherapy (60 Gy']","['HRQOL, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 and the EORTC brain cancer module (BN20); and neurocognitive function, assessed using the Mini Mental State Examination (MMSE), plus a neurocognitive test battery (NOA-07), including Trail Making Test A and B (TMT-A and B), working memory tests, and tests for lexical (Controlled Oral Word Association [COWA]) and semantic verbal fluency', 'overall survival', 'MMSE', 'HRQOL', 'global health 0·30', 'health-related quality of life (HRQOL) and neurocognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0153633', 'cui_str': 'Brain Cancer'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",141.0,0.416338,We found no significant impairment regarding any item of HRQOL in the lomustine-temozolomide group (difference between the groups for global health 0·30,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Weller', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Theophilos', 'Initials': 'T', 'LastName': 'Tzaridis', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Mack', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Joachim Peter', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schlegel', 'Affiliation': 'Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hau', 'Affiliation': 'Department of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Krex', 'Affiliation': 'Department of Neurosurgery, University of Dresden, Dresden, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grauer', 'Affiliation': 'Department of Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Goldbrunner', 'Affiliation': 'Department of Neurosurgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bähr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Uhl', 'Affiliation': 'Department of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Seidel', 'Affiliation': 'Department of Radiation Oncology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Tabatabai', 'Affiliation': 'Interdisciplinary Division of Neurooncology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Brehmer', 'Affiliation': 'Department of Neurosurgery, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Department of Internal Medicine, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Galldiks', 'Affiliation': 'Department of Neurology, University of Cologne, Cologne, Germany; Institute of Neuroscience and Medicine, Forschungszentrum Juelich, Juelich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schaub', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Sied', 'Initials': 'S', 'LastName': 'Kebir', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Stummer', 'Affiliation': 'Department of Neurosurgery, University of Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Department of Neurosurgery, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Coch', 'Affiliation': 'Study Center Bonn, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Glas', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and West German Cancer Center, German Cancer Consortium, Partner Site Essen, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Herrlinger', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany. Electronic address: ulrich.herrlinger@ukbonn.de.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Schäfer', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30502-9'] 1384,27276026,Commentary: Can't WaSH Without Water: Instrumental Variables Evidence from a Randomized Trial.,,2016,,[],"[""Can't WaSH""]",[],[],"[{'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}]",[],,0.14883,,"[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bor', 'Affiliation': 'From the Departments of Global Health and Epidemiology, Boston University School of Public Health, Boston, MA.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000000523'] 1385,26482674,Promoting HPV Vaccination in Safety-Net Clinics: A Randomized Trial.,"OBJECTIVES Evaluate effects of a multicomponent intervention (human papillomavirus [HPV] vaccine-specific brochure and recalls) on HPV vaccination and secondarily examine if race/ethnicity moderates effects. METHODS Unvaccinated girls aged 11 to 18 years attending 4 safety-net pediatric clinics and their parent/guardian (n = 814 dyads) were randomized to (1) active comparison (general adolescent vaccine brochure), or (2) intervention consisting of a HPV vaccine-specific brochure, telephone recalls to parents who declined, and recalls to patients overdue for doses 2 and 3. HPV 1-dose and 3-dose coverages were assessed via electronic health records 12 months after randomization. Multivariate logistic regressions estimated adjusted odds and marginal predicted vaccine coverage by study arm and race/ethnicity. RESULTS Intent-to-treat analyses found no main effect of the HPV vaccine-specific brochure on 1-dose coverage (42.0% vs 40.6%); however, secondary analyses found race/ethnicity was a significant moderator such that the intervention was effective only for Hispanic individuals (adjusted odds ratio [AOR] 1.43; 95% confidence interval [CI] 1.02-2.02), and not effective for black individuals (AOR 0.64; 95% CI 0.41-1.13). Recalls to parents who declined the vaccine during the index visit were not effective, but recalls to patients overdue for doses 2 and 3 were effective at increasing 3-dose coverage regardless of race/ethnicity (AOR 1.99; 95% CI 1.16-3.45). CONCLUSIONS Educational materials describing only the HPV vaccine were effective for Hispanic but not black individuals. Future research should test mechanisms that may mediate intervention effects for different racial/ethnic groups, such as different informational needs or vaccine schemas (experiences, beliefs, norms).",2015,"Recalls to parents who declined the vaccine during the index visit were not effective, but recalls to patients overdue for doses 2 and 3 were effective at increasing 3-dose coverage regardless of race/ethnicity (AOR 1.99; 95% CI 1.16-3.45). ",['Unvaccinated girls aged 11 to 18 years attending 4 safety-net pediatric clinics and their parent/guardian (n = 814 dyads'],"['active comparison (general adolescent vaccine brochure), or (2) intervention consisting of a HPV vaccine-specific brochure, telephone recalls to parents who declined, and recalls to patients overdue for doses 2 and 3', 'multicomponent intervention (human papillomavirus [HPV] vaccine-specific brochure and recalls', 'HPV vaccine-specific brochure']","['HPV 1-dose and 3-dose coverages', '1-dose coverage']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}]",814.0,0.176642,"Recalls to parents who declined the vaccine during the index visit were not effective, but recalls to patients overdue for doses 2 and 3 were effective at increasing 3-dose coverage regardless of race/ethnicity (AOR 1.99; 95% CI 1.16-3.45). ","[{'ForeName': 'Jasmin A', 'Initials': 'JA', 'LastName': 'Tiro', 'Affiliation': 'University of Texas Southwestern Medical Center and Simmons Cancer Center, Dallas, Texas; jasmin.tiro@utsouthwestern.edu.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Sanders', 'Affiliation': 'University of Texas Southwestern Medical Center and Simmons Cancer Center, Dallas, Texas;'}, {'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Pruitt', 'Affiliation': 'University of Texas Southwestern Medical Center and Simmons Cancer Center, Dallas, Texas;'}, {'ForeName': 'Clare Frey', 'Initials': 'CF', 'LastName': 'Stevens', 'Affiliation': 'Rand Corporation, Arlington, Virginia; and.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'University of Texas Southwestern Medical Center and Simmons Cancer Center, Dallas, Texas;'}, {'ForeName': 'Wendy P', 'Initials': 'WP', 'LastName': 'Bishop', 'Affiliation': 'University of Texas Southwestern Medical Center and Simmons Cancer Center, Dallas, Texas;'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Fuller', 'Affiliation': 'Parkland Health and Hospital System, Dallas, Texas.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Persaud', 'Affiliation': 'Parkland Health and Hospital System, Dallas, Texas.'}]",Pediatrics,['10.1542/peds.2015-1563'] 1386,28129069,Placement and Format of Risk Information on Direct-to-Consumer Prescription Drug Websites.,"We investigated whether the location and format of risk information on branded prescription drug websites influence consumers' knowledge and perceptions of the drug's risks. Participants (Internet panelists with high cholesterol [n = 2,609] or seasonal allergies [n = 2,637]) were randomly assigned to view a website promoting a fictitious prescription drug for their condition. The website presented risk information at the bottom of the homepage, or at the bottom of the homepage with a signal above indicating that the risk information was located below, or on a linked secondary page. We also varied the format of risk information (paragraph, checklist, bulleted list, highlighted box). Participants then answered questions on risk recall and perceptions. Participants recalled fewer drug risks when the risks were placed on a secondary page. The signal had little effect, and risk information format did not affect outcomes. The location of risk information on prescription drug websites can affect consumer knowledge of drug risks; however, signals and special formatting may not be necessary for websites to adequately inform consumers about drug risks. We recommend that prescription drug websites maintain risk information on their homepages to achieve ""fair balance"" as required by the U.S. Food and Drug Administration.",2017,We investigated whether the location and format of risk information on branded prescription drug websites influence consumers' knowledge and perceptions of the drug's risks.,"['2,609] or seasonal allergies [n\xa0=\xa02,637', 'Participants (Internet panelists with high cholesterol [n\xa0']",[],"['risk recall and perceptions', 'drug risks']","[{'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",,0.0176115,We investigated whether the location and format of risk information on branded prescription drug websites influence consumers' knowledge and perceptions of the drug's risks.,"[{'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': 'a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}, {'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': 'a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rupert', 'Affiliation': 'b RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Jessica Fitts', 'Initials': 'JF', 'LastName': 'Willoughby', 'Affiliation': 'b RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}]",Journal of health communication,['10.1080/10810730.2016.1258745'] 1387,29533303,"Brief Report: Changes in Plasma RANKL-Osteoprotegerin in a Prospective, Randomized Clinical Trial of Initial Antiviral Therapy: A5260s.","BACKGROUND The contributions of the receptor activator of nuclear factor kappa-B ligand (RANKL)/osteoprotegerin (OPG) axis to cardiovascular and bone disease in treated HIV-1 infection are not well defined. SETTING Prospective, observational, longitudinal study. METHODS In a subset analysis of a prospective randomized clinical trial, 234 HIV-1-infected antiretroviral therapy-naive participants received tenofovir-emtricitabine plus either atazanavir/ritonavir, darunavir/ritonavir, or raltegravir and achieved plasma HIV-1 RNA <50 copies per milliliter by week 24 and thereafter. Associations between plasma RANKL, OPG, or RANKL/OPG ratio levels with total, hip, and spine bone mineral density (BMD) loss or progression of carotid artery intima-media thickness were assessed longitudinally over 96 weeks. RESULTS Over 96 weeks, all treatment groups had similar and sustained declines in plasma RANKL, increases in plasma OPG, and subsequently, decreases in the RANKL/OPG ratio. There were no associations between plasma RANKL or RANKL/OPG ratio levels with total, hip, and spine BMD loss or progression of carotid artery intima-media thickness; however, plasma OPG in successfully treated HIV-infected patients (week 48 and 96) was associated with spine BMD loss. CONCLUSIONS In virologically suppressed HIV-infected patients, the evolution of bone disease could be linked to plasma OPG levels; however, the role of plasma levels of RANKL and RANKL/OPG ratio in the prediction of morbidity in treated HIV-1 infection may be limited.",2018,"There were no associations between plasma RANKL or RANKL/OPG ratio levels with total, hip, and spine BMD loss or progression of carotid artery intima-media thickness; however, plasma OPG in successfully treated HIV-infected patients (week 48 and 96) was associated with spine BMD loss. ",['234 HIV-1-infected antiretroviral therapy-naive participants received'],"['tenofovir-emtricitabine plus either atazanavir/ritonavir, darunavir/ritonavir, or raltegravir and achieved plasma HIV-1 RNA']","['RANKL)/osteoprotegerin (OPG) axis to cardiovascular and bone disease', 'plasma RANKL or RANKL/OPG ratio levels with total, hip, and spine BMD loss or progression of carotid artery intima-media thickness; however, plasma OPG', 'plasma OPG, and subsequently, decreases in the RANKL/OPG ratio', 'HIV-1', 'spine BMD loss', 'plasma RANKL, OPG, or RANKL/OPG ratio levels with total, hip, and spine bone mineral density (BMD) loss or progression of carotid artery intima-media thickness']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",234.0,0.0484364,"There were no associations between plasma RANKL or RANKL/OPG ratio levels with total, hip, and spine BMD loss or progression of carotid artery intima-media thickness; however, plasma OPG in successfully treated HIV-infected patients (week 48 and 96) was associated with spine BMD loss. ","[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Kelesidis', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Carlee B', 'Initials': 'CB', 'LastName': 'Moser', 'Affiliation': 'Department of Medicine, Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': 'Department of Medicine, Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dube', 'Affiliation': 'Department of Medicine, Keck School of Medicine at the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Otto O', 'Initials': 'OO', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': 'Department of Medicine, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Keck School of Medicine at the University of Southern California, Los Angeles, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001679'] 1388,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants. METHODS By way of two separately conducted between-subjects experiments, effects of 1) a low (29 g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80 g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood. RESULTS Experiment-1: The 29 g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30 min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90 min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80 g sucrose containing beverage caused a large (72%) glycemic peak response at +30 min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80 g sugar beverage, blood glucose concentrations remained elevated (13%) at +120 min and returned to lower baseline values in the direction of hypoglycemia levels at +165 min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood. CONCLUSIONS The current findings indicate that instead of a low (29 g) sugar-containing beverage, a high (80 g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165 min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht, Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology, Maastricht, Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916'] 1389,32416072,"Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma. METHODS This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857. FINDINGS Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths. INTERPRETATION Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma. FUNDING Agios Pharmaceuticals.",2020,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"['mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma', 'patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1', 'Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients']","['Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy', 'ivosidenib or placebo', 'Placebo', 'oral ivosidenib 500 mg or matched placebo', 'ivosidenib', 'ivosidenib (AG-120)-a small-molecule targeted inhibitor', 'placebo']","['Safety', 'tolerated', 'progression-free survival', 'Median follow-up for progression-free survival', 'adverse event', 'efficacy and safety', 'Progression-free survival', 'Serious adverse events']","[{'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C4682397', 'cui_str': 'ivosidenib'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3827169', 'cui_str': 'AG-120'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",230.0,0.76452,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Milind M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lubner', 'Affiliation': 'Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Department of Hematology-Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Medical Oncology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Harris', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Murphy', 'Affiliation': 'Department of Oncology-Gastrointestinal Cancer, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whisenant', 'Affiliation': 'Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City, UT, USA.'}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachna T', 'Initials': 'RT', 'LastName': 'Shroff', 'Affiliation': 'Department of Medicine, University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christina X', 'Initials': 'CX', 'LastName': 'Chamberlain', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Gliser', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Shuchi S', 'Initials': 'SS', 'LastName': 'Pandya', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; Jiahui International Cancer Center, Jiahui Health, Shanghai, China. Electronic address: azhu@mgh.harvard.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30157-1'] 1390,32492824,A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study.,"BACKGROUND Our aim was to understand cancer survivor needs prior to, and following the Alberta Cancer Exercise (ACE) pilot randomized trial as a means to inform implementation of a province-wide cancer-specific, community-based exercise program. METHODS Questionnaires and semi-structured stakeholder engagement sessions were conducted with cancer survivors to explore preferences, barriers and facilitators/benefits at two timepoints: (1) pre-ACE: prior to initiation of the ACE pilot trial ( n = 13 survivors and n = 5 caregivers); and (2) post-ACE: following participation in the ACE pilot trial ( n = 20 survivors). Descriptive statistics were used to summarize quantitative data from questionnaires. Stakeholder engagement data were analyzed using a framework analysis approach. Emergent themes were then mapped to actionable outcomes. RESULTS Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible. Post-ACE, participants identified (1) a lack of exercise counseling from health care providers, (2) the need for earlier introduction of exercise in the care pathway, and (3) supported referral to exercise programming. CONCLUSIONS An integrated knowledge translation approach identified actionable outcomes to address survivor needs related to exercise in clinical cancer and community-based contexts.",2020,"Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible.",[],['Questionnaires and semi-structured stakeholder engagement sessions'],[],[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4704677', 'cui_str': 'Stakeholder Engagement'}]",[],,0.0432749,"Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible.","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Suderman', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Dolgoy', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Yurick', 'Affiliation': 'Cross Cancer Institute, Alberta Health Services, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sellar', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Anil A', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Cross Cancer Institute, Alberta Health Services, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17113911'] 1391,31552526,Omalizumab versus intranasal steroids in the post-operative management of patients with allergic fungal rhinosinusitis.,"PURPOSE Allergic fungal rhinosinusitis (AFRS) is a common disorder with a high prevalence and a very high incidence of recurrence. Management includes surgery and medical treatment in the form of local and/or systemic steroids. However, some cases are resistant to the action of steroids and further treatment is warranted. Being an immune-mediated disorder, targeting IgE seems a logical step. Immunotherapy drugs acting on the IgE (e.g. omalizumab) can modify the clinical course of the disease. This study aimed at evaluating the effect of omalizumab on the clinical course of patients undergoing surgery for AFRS. MATERIALS AND METHODS This is a two-arm prospective, randomized, single blind clinical trial among patients with AFRS. Twenty patients were included and randomly divided into two groups: Group A; 10 patients received a single subcutaneous injection of omalizumab (Xolair ' Novartis) (150 mg) 2 weeks postoperatively. Group B: 10 patients received local steroids nasal sprays (budesonide or mometasone furoate, 100 μg twice daily for 6 months, starting 2 weeks postoperatively. All patients underwent history, examination, CT scan and IgE level estimation and were submitted to endoscopic sinus surgery. They were evaluated at 4 weeks interval for 6 months. RESULTS In both groups there were highly significant differences between pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores. Comparison between the two study groups at 24 weeks showed a highly significant difference (p = 0.001) between post-operative SNOT 20 and TNSS scores in favour of group A. There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores. There were two recurrences in both arms, but no significant side effects. DISCUSSION We compared a single post operative injection of omalizumab with twice daily intranasal steroid spray for 6 months. Both treatments were effective, but the omalizumab group showed a more significant clinical and endoscopic response. There were no significant side effects in both arms. This novel approach used a single low dose injection of omalizumab increased the compliance of the patients with minimal complications. Longer follow-up of the patients is ongoing to determine the optimal time for re-injection. The only downside was the higher cost of omalizumab compared to that of local steroids.",2020,There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores.,"['patients undergoing surgery for AFRS', 'patients with allergic fungal rhinosinusitis', '10 patients received', 'patients with AFRS', 'Allergic fungal rhinosinusitis (AFRS', 'Twenty patients', 'patients with minimal complications']","['endoscopic sinus surgery', 'omalizumab', 'Omalizumab versus intranasal steroids', ""single subcutaneous injection of omalizumab (Xolair ' Novartis"", 'omalizumab with twice daily intranasal steroid spray', 'local steroids nasal sprays (budesonide or mometasone furoate']","['side effects', 'TNSS scores', 'clinical and endoscopic response', 'pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores', 'postoperative total IgE or Philpott-Javer scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0948780', 'cui_str': 'Rhinosinusitis'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C1174773', 'cui_str': 'Xolair'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.0231268,There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores.,"[{'ForeName': 'Badr Eldin', 'Initials': 'BE', 'LastName': 'Mostafa', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt. bemostafa@med.asu.edu.eg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fadel', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}, {'ForeName': 'Mohammed Amir', 'Initials': 'MA', 'LastName': 'Mohammed', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}, {'ForeName': 'Tarek Abdel Hamid', 'Initials': 'TAH', 'LastName': 'Hamdi', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}, {'ForeName': 'Anas Mohammed', 'Initials': 'AM', 'LastName': 'Askoura', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Ain-Shams University, 75 El Nozha Street, Heliopolis-Cairo, 11351, Egypt.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05650-y'] 1392,27933425,Ethical Issues in Using Social Media to Deliver an HIV Prevention Intervention: Results from the HOPE Peru Study.,"Social media technologies have become increasingly useful tools for research-based interventions. However, participants and social media users have expressed ethical concerns with these studies, such as risks and benefits of participation, as well as privacy, confidentiality, and informed consent issues. This study was designed to follow up with and assess experiences and perceptions of ethics-related issues among a sample of 211 men who have sex with men who participated in the Harnessing Online Peer Education (HOPE) Peru study, a randomized controlled HIV prevention intervention conducted in Peru. We found that after adjusting for age, highest educational attainment, race, sexual orientation, and prior HIV research experience, participants in the intervention group were more likely than those in the control group to have safe sex (p = 0.0051) and get tested for HIV regularly (p = 0.0051). As a result of their participation, those in the intervention group benefited more positively than participants in the control group in improving HIV care (p = 0.0077) and learning where to receive sexual health services (p = 0.0021). Participants in the intervention group expressed higher levels of comfort than those in the control group in joining and seeing other people in the Facebook group (p = 0.039), seeing other people's posts (p = 0.038) and having other group members talk to them online (p = 0.040). We discuss the implications of these results as they relate to social media-based HIV research.",2017,"Participants in the intervention group expressed higher levels of comfort than those in the control group in joining and seeing other people in the Facebook group (p = 0.039), seeing other people's posts (p = 0.038) and having other group members talk to them online (p = 0.040).",['211 men who have sex with men who participated in the Harnessing Online Peer Education (HOPE'],['HIV Prevention Intervention'],"['higher levels of comfort', 'improving HIV care']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C3873748', 'cui_str': 'Harness (physical object)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0392347', 'cui_str': 'Hope'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",211.0,0.0222352,"Participants in the intervention group expressed higher levels of comfort than those in the control group in joining and seeing other people in the Facebook group (p = 0.039), seeing other people's posts (p = 0.038) and having other group members talk to them online (p = 0.040).","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Garett', 'Affiliation': 'LCSW, ElevateU, Los Angeles, CA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Menacho', 'Affiliation': 'Espacio Commun (Epicentro), Lima, Peru.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'UCLA Center for Digital Behavior, Department of Family Medicine, University of California, Los Angeles (UCLA), 10880 Wilshire Blvd., Suite 1800, Los Angeles, CA, 90024, USA. sdyoung@mednet.ucla.edu.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-016-0739-z'] 1393,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial. MATERIAL AND METHODS A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed. RESULTS Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. CONCLUSION Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006'] 1394,31562059,"Bubble continuous positive airway pressure for children with high-risk conditions and severe pneumonia in Malawi: an open label, randomised, controlled trial.","BACKGROUND Pneumonia is the leading cause of death among children globally. Most pneumonia deaths in low-income and middle-income countries (LMICs) occur among children with HIV infection or exposure, severe malnutrition, or hypoxaemia despite antibiotics and oxygen. Non-invasive bubble continuous positive airway pressure (bCPAP) is considered a safe ventilation modality that might improve child pneumonia survival. bCPAP outcomes for high-risk African children with severe pneumonia are unknown. Since most child pneumonia hospitalisations in Africa occur in non-tertiary district hospitals without daily physician oversight, we aimed to examine whether bCPAP improves severe pneumonia mortality in such settings. METHODS This open-label, randomised, controlled trial was done in the general paediatric ward of Salima District Hospital, Malawi. We enrolled children aged 1-59 months old with WHO-defined severe pneumonia and either HIV infection or exposure, severe malnutrition, or an oxygen saturation of less than 90%. Children were randomly assigned 1:1 to low-flow nasal cannula oxygen or nasal bCPAP. Non-physicians administered care; the primary outcome was hospital survival. Primary analyses were by intention-to-treat and interim and adverse events analyses per protocol. This trial is registered with ClinicalTrials.gov, number NCT02484183, and is closed. FINDINGS We screened 1712 children for eligibility between June 23, 2015, and March 21, 2018. The data safety and monitoring board stopped the trial for futility after 644 of the intended 900 participants were enrolled. 323 children were randomly assigned to oxygen and 321 to bCPAP. 35 (11%) of 323 children who received oxygen died in hospital, as did 53 (17%) of 321 who received bCPAP (relative risk 1·52; 95% CI 1·02-2·27; p=0·036). 13 oxygen and 17 bCPAP patients lacked hospital outcomes and were considered lost to follow-up. Suspected adverse events related to treatment occurred in 11 (3%) of 321 children receiving bCPAP and 1 (<1%) of 323 children receiving oxygen. Four bCPAP and one oxygen group deaths were classified as probable aspiration episodes, one bCPAP death as probable pneumothorax, and six non-death bCPAP events included skin breakdown around the nares. INTERPRETATION bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen. The use of bCPAP within certain patient populations and non-intensive care settings might carry risk that was not previously recognised. bCPAP in LMICs needs further evaluation before wider implementation for child pneumonia care. FUNDING Bill & Melinda Gates Foundation, International AIDS Society, Health Empowering Humanity.",2019,"INTERPRETATION bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen.","['high-risk African children with severe pneumonia', '321 children receiving', '323 children', 'general paediatric ward of Salima District Hospital, Malawi', '1712 children for eligibility between June 23, 2015, and March 21, 2018', '323 children receiving oxygen', 'children with HIV infection or exposure, severe malnutrition, or hypoxaemia despite antibiotics and oxygen. Non-invasive bubble continuous positive airway pressure (bCPAP', 'futility after 644 of the intended 900 participants were enrolled', 'children with high-risk conditions and severe pneumonia in Malawi', 'enrolled children aged 1-59 months old with WHO-defined severe pneumonia and either HIV infection or exposure, severe malnutrition, or an oxygen saturation of less than 90']","['bCPAP', 'Bubble continuous positive airway pressure', 'low-flow nasal cannula oxygen or nasal bCPAP']","['hospital mortality', 'severe pneumonia mortality', 'hospital survival', 'intention-to-treat and interim and adverse events analyses per protocol', 'hospital outcomes', 'bCPAP outcomes']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",900.0,0.254718,"INTERPRETATION bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen.","[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: emccoll3@jhmi.edu.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi; Department of Pediatrics, School of Medicine, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eckerle', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Davie', 'Initials': 'D', 'LastName': 'Kondowe', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Makonokaya', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Dhananjay', 'Initials': 'D', 'LastName': 'Vaidya', 'Affiliation': 'BEAD Core, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Billioux', 'Affiliation': 'BEAD Core, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Chalira', 'Affiliation': 'Malawi Ministry of Heath, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Malawi Ministry of Heath, Lilongwe, Malawi.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Mofolo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi; Division of Infectious Disease, University of North Carolina at Chapel Hill, NC, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30243-7'] 1395,31924485,A Comparative Study of Two Tube Feeding Methods in Patients with Dysphagia After Stroke: A Randomized Controlled Trial.,"BACKGROUND Dysphagia is a common symptom seen in stroke patients, it not only affects patients' nutrition supply, but also causes aspiration pneumonia. To solve the problem of nutritional support for patients with dysphagia after stroke, nasogastric tubes are routinely indwelling to provide nutrition in China. However, this feeding method sometimes causes food reflux, aspiration, pneumonia, and often affects the patients' comfort and self-image acceptance. AIM The aim of this study was to determine whether a new feeding method called intermittent oroesophageal (IOE) tube feeding compared with continuous nasogastric tube feeding as a practical and beneficial mean of decreasing the rate of stroke associated pneumonia (SAP), and improving patients' swallowing function, comfort, psychological status. DESIGN This was an assessor-blinded, single-center, randomized controlled trial. METHODS Ninety-seven hospitalized stroke patients with dysphagia in the rehabilitation department from January to December 2018 were randomized to a control group and an intervention group. Patients in both groups received routine nursing, rehabilitation treatment and swallowing therapy. Patients in the intervention group were given IOE tube feeding, while those in the control group were fed by indwelling nasogastric tube. Outcomes were assessed at admission, discharge or the end of the tube feeding. RESULTS The incidence of SAP in the intervention group was 16.33% lower than that (31.25%) in the control group; the comfort score (2.08 ± .64), anxiety score (10.98 ± 2.28), depression score (7.39 ± 2.16) were lower than those (3.02 ± .70), (12.10 ± 2.18), (8.42 ± 2.34) in the control group. The improvement rate of swallowing function in the intervention group was 83.67% higher than that (66.67%) in the control group (all P < .05). CONCLUSIONS The IOE tube feeding compared with continuous tube feeding may reduce the incidence of SAP, and improve patients' swallowing function, comfort, psychological status in patients with dysphagia after stroke.",2020,"The IOE tube feeding compared with continuous tube feeding may reduce the incidence of SAP, and improve patients' swallowing function, comfort, psychological status in patients with dysphagia after stroke.","['Patients with Dysphagia After Stroke', 'stroke patients', 'Ninety-seven hospitalized stroke patients with dysphagia in the rehabilitation department from January to December 2018', 'patients with dysphagia after stroke', 'patients with dysphagia after stroke, nasogastric tubes']","['new feeding method called intermittent oroesophageal (IOE) tube feeding compared with continuous nasogastric tube feeding', 'indwelling nasogastric tube', 'Two Tube Feeding Methods', 'IOE tube feeding', 'routine nursing, rehabilitation treatment and swallowing therapy']","['incidence of SAP', 'comfort score', ""rate of stroke associated pneumonia (SAP), and improving patients' swallowing function, comfort, psychological status"", 'admission, discharge or the end of the tube feeding', 'depression score', ""patients' swallowing function, comfort, psychological status"", 'improvement rate of swallowing function', 'anxiety score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric tube feeding'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589274', 'cui_str': 'Swallowing promotion therapy (regime/therapy)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",97.0,0.0515318,"The IOE tube feeding compared with continuous tube feeding may reduce the incidence of SAP, and improve patients' swallowing function, comfort, psychological status in patients with dysphagia after stroke.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Juan', 'Affiliation': 'Department of Rehabilitation Medicine, Guangzhou Panyu Central Hospital, China. Electronic address: chenxi1105@163.com.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Zhen', 'Affiliation': 'Department of Rehabilitation Medicine, Guangzhou Panyu Central Hospital, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yan-Ying', 'Affiliation': 'Nursing Department, Guangzhou Panyu Central Hospital, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hui-Xian', 'Affiliation': 'Department of Rehabilitation Medicine, Guangzhou Panyu Central Hospital, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Rehabilitation Medicine, Guangzhou Panyu Central Hospital, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Pei-Fen', 'Affiliation': 'Department of Rehabilitation Medicine, Guangzhou Panyu Central Hospital, China.'}, {'ForeName': 'Huo', 'Initials': 'H', 'LastName': 'Jian-Tian', 'Affiliation': 'Department of Rehabilitation Medicine, Guangzhou Panyu Central Hospital, China.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2019.104602'] 1396,31575509,"Pamrevlumab, an anti-connective tissue growth factor therapy, for idiopathic pulmonary fibrosis (PRAISE): a phase 2, randomised, double-blind, placebo-controlled trial.","BACKGROUND Connective tissue growth factor (CTGF) is a secreted glycoprotein that has a central role in the process of fibrosis. This study was designed to assess the safety, tolerability, and efficacy of pamrevlumab (FG-3019), a fully recombinant human monoclonal antibody against CTGF, in idiopathic pulmonary fibrosis. The aim was to establish whether pamrevlumab could slow, stop, or reverse progression of idiopathic pulmonary fibrosis. METHODS The phase 2, randomised, double-blind, placebo-controlled PRAISE trial was done at 39 medical centres in seven countries (Australia, Bulgaria, Canada, India, New Zealand, South Africa, and the USA). Patients with idiopathic pulmonary fibrosis and percentage of predicted forced vital capacity (FVC) of 55% or greater were enrolled and randomly assigned (1:1) by use of interactive responsive technology to intravenous infusion of pamrevlumab 30 mg/kg or placebo every 3 weeks over 48 weeks (16 infusions). The primary efficacy outcome was change from baseline in percentage of predicted FVC at week 48. Disease progression (defined as a decline from baseline in percentage of predicted FVC of ≥10%, or death) at week 48 was a key secondary efficacy outcome. All patients in the pamrevlumab group received at least one dose of the study drug and were analysed for safety. Two patients in the placebo group were excluded from the intention-to-treat population for the efficacy analyses because of enrolment error. This trial is registered with ClinicalTrials.gov, NCT01890265. FINDINGS Between Aug 17, 2013, and July 21, 2017, 103 patients were randomly assigned (50 to pamrevlumab and 53 to placebo). Pamrevlumab reduced the decline in percentage of predicted FVC by 60·3% at week 48 (mean change from baseline -2·9% with pamrevlumab vs -7·2% with placebo; between-group difference 4·3% [95% CI 0·4-8·3]; p=0·033). The proportion of patients with disease progression was lower in the pamrevlumab group than in the placebo group at week 48 (10·0% vs 31·4%; p=0·013). Pamrevlumab was well tolerated, with a safety profile similar to that of placebo. Treatment-emergent serious adverse events were observed in 12 (24%) patients in the pamrevlumab group and eight (15%) in the placebo group, with three patients on pamrevlumab and seven on placebo discontinuing treatment. Of the three (6%) deaths in the pamrevlumab group and six (11%) in the placebo group, none was considered treatment related. INTERPRETATION Pamrevlumab attenuated progression of idiopathic pulmonary fibrosis and was well tolerated. Now in phase 3 development, pamrevlumab shows promise as a novel, safe, and effective treatment for idiopathic pulmonary fibrosis. FUNDING FibroGen.",2020,The proportion of patients with disease progression was lower in the pamrevlumab group than in the placebo group at week 48 (10·0% vs 31·4%; p=0·013).,"['Patients with idiopathic pulmonary fibrosis and percentage of predicted forced vital capacity (FVC) of 55% or greater were enrolled and randomly assigned (1:1) by use of', 'idiopathic pulmonary fibrosis', 'idiopathic pulmonary fibrosis (PRAISE', '39 medical centres in seven countries (Australia, Bulgaria, Canada, India, New Zealand, South Africa, and the USA', 'Between Aug 17, 2013, and July 21, 2017, 103 patients']","['Pamrevlumab, an anti-connective tissue growth factor therapy', 'placebo', 'Connective tissue growth factor (CTGF', 'interactive responsive technology to intravenous infusion of pamrevlumab 30 mg/kg or placebo', 'recombinant human monoclonal antibody against CTGF', 'pamrevlumab and 53 to placebo', 'pamrevlumab (FG-3019']","['proportion of patients with disease progression', 'Disease progression', 'safety, tolerability, and efficacy', 'Treatment-emergent serious adverse events', 'percentage of predicted FVC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C2919678', 'cui_str': 'Percentage of predicted forced vital capacity (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0557963', 'cui_str': 'Praising (procedure)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C0110610', 'cui_str': 'IGF-Binding Protein-Related Protein-2'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C2985186', 'cui_str': 'FG 3019'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",103.0,0.649002,The proportion of patients with disease progression was lower in the pamrevlumab group than in the placebo group at week 48 (10·0% vs 31·4%; p=0·013).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: luca.richeldi@policlinicogemelli.it.'}, {'ForeName': 'Evans R', 'Initials': 'ER', 'LastName': 'Fernández Pérez', 'Affiliation': 'National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Costabel', 'Affiliation': 'Ruhrlandklinik, University Hospital, Essen, Germany.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Albera', 'Affiliation': 'University of Torino, Italy.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ettinger', 'Affiliation': ""St Luke's Hospital, Chesterfield, MO, USA.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perez', 'Affiliation': 'University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Scholand', 'Affiliation': 'University of Utah, Lung Health Research, Salt Lake City, UT, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'MedQIA, Los Angeles, CA, USA.'}, {'ForeName': 'Kin-Hung', 'Initials': 'KH', 'LastName': 'Peony Yu', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gorina', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kouchakji', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington Medical Center, Seattle, WA, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30262-0'] 1397,31568390,Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients: A Randomized Controlled Trial.,"BACKGROUND New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven. METHODS We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints. RESULTS Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, -446; 95% confidence interval [CI], -3184 to 2292; P = 0.748), insulin sensitivity (mean difference, -0.45; 95% CI, -1.34 to 0.44; P = 0.319), or disposition index (mean difference, -940; 95% CI, -5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, -1.537 kg; 95% CI, -2.947 to -0.127; P = 0.033), and improvement in weight (mean difference, -2.47 kg; 95% CI, -4.01 to -0.92; P = 0.002). No serious adverse events were noted. CONCLUSIONS Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.",2020,Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446,"['130 nondiabetic kidney transplant recipients with stable function between 3-24 months post transplantation', 'Between August 17 2015 and December 18 2017, 130 individuals were recruited of whom 103 completed the study (drop-out rate 20.8', 'kidney allograft recipients (CAVIAR']","['active versus passive lifestyle intervention', 'active intervention (lifestyle advice delivered by renal dietitians using behaviour change techniques) versus passive intervention (leaflet advice alone']","['insulin sensitivity', 'six-month change in insulin secretion, insulin sensitivity and disposition index', 'reduced incidence of post transplantation diabetes', 'patient-reported outcomes, cardio-metabolic parameters, clinical outcomes and safety endpoints', 'disposition index', 'surrogate markers of glucose metabolism', 'glucose metabolism; insulin secretion', 'reduction in fat mass', 'weight', 'serious adverse events']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C2347573', 'cui_str': 'Caviar (substance)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0586938', 'cui_str': 'Renal dietitian (occupation)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",130.0,0.460737,Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446,"[{'ForeName': 'Kulli', 'Initials': 'K', 'LastName': 'Kuningas', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Driscoll', 'Affiliation': 'Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mair', 'Affiliation': 'Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Smith', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dutton', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'And Adnan', 'Initials': 'AA', 'LastName': 'Sharif', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}]",Transplantation,['10.1097/TP.0000000000002969'] 1398,32419540,Fractional CO 2 -assisted photodynamic therapy improves the clinical outcome and patient's satisfaction in toenail onychomycosis treatment: an intra-patient comparative single-center study.,"Background: Device-based therapies have been used for onychomycosis patients with intolerance to systemic treatments. Photodynamic therapy (PDT) improves onychomycosis, while fractional carbon dioxide (FrCO 2 ) augments the topical drug delivery. Comparative studies between PDT alone and laser-assisted one are lacking. Objective: We aimed to evaluate the efficacy of PDT alone versus FrCO 2 -assisted PDT for treatment of onychomycosis. Methods: Twenty-one patients with bilateral onychomycosis of toenails with nearly the same degree of affection were enrolled in this prospective intra-patient-controlled study. The right affected toenail was treated via PDT alone. The left toenail was treated via a FrCO 2 followed immediately by PDT. The sessions were bimonthly for a total of six sessions. Direct microscopy, fungal cultures, clinical evaluation, onychomycosis severity index scoring, and patient's satisfaction were assessed before and 12 weeks after the last session. Results: Both treatments reduced significantly the onychomycosis severity index ( p  < .05) without significant difference between them. The improvement in nail appearance and patient's satisfaction were higher in laser-assisted PDT than PDT alone ( p  < .05). Conclusion: Both treatments effectively reduced the severity of onychomycosis with a high degree of safety and tolerability. Fractional CO 2 -assisted PDT enhanced the clinical outcome via improving the nail appearance and patient's satisfaction.Key messagePhotodynamic therapy has a good success rate in clearing onychomycosis. Addition of fractional CO 2 to photodynamic therapy improves the nail appearance and induces better satisfaction to treatment.",2020,Both treatments reduced significantly the onychomycosis severity index (p < 0.05) without significant difference between them.,"['onychomycosis patients with intolerance to systemic treatments', 'Twenty-one patients with bilateral onychomycosis of toenails with nearly the same degree of affection']","['Photodynamic therapy (PDT', 'Fractional CO 2 -assisted photodynamic therapy', 'photodynamic therapy', 'Photodynamic therapy', 'PDT alone versus FrCO']","['onychomycosis severity index', ""nail appearance and patient's satisfaction"", 'safety and tolerability', 'nail appearance', ""Direct microscopy, fungal cultures, clinical evaluation, onychomycosis severity index scoring, and patient's satisfaction"", 'severity of onychomycosis']","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1274470', 'cui_str': 'Onychomycosis of toenails'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600070', 'cui_str': 'Direct microscopy'}, {'cui': 'C0200954', 'cui_str': 'Mycology culture'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]",21.0,0.0238875,Both treatments reduced significantly the onychomycosis severity index (p < 0.05) without significant difference between them.,"[{'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Abdallah', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mustafa M', 'Initials': 'MM', 'LastName': 'Abu-Ghali', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Taha', 'Initials': 'MT', 'LastName': 'El-Sayed', 'Affiliation': 'Department of Microbiology and Immunology, Faculty of Veterinary Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Marwa Y', 'Initials': 'MY', 'LastName': 'Soltan', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1771252'] 1399,31553469,Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial.,"Importance Owing to biological, behavioral, and societal factors, sleep duration in teenagers is often severely truncated, leading to pervasive sleep deprivation. Objective To determine whether a novel intervention, using both light exposure during sleep and cognitive behavioral therapy (CBT), would increase total sleep time in teenagers by enabling them to go to sleep earlier than usual. Design, Setting, and Participants This double-blind, placebo-controlled, randomized clinical trial, conducted between November 1, 2013, and May 31, 2016, among 102 adolescents enrolled full-time in grades 9 to 12, who expressed difficulty going to bed earlier and waking up early enough, was composed of 2 phases. In phase 1, participants were assigned to receive either 3 weeks of light or sham therapy and were asked to try to go to sleep earlier. In phase 2, participants received 4 brief CBT sessions in addition to a modified light or sham therapy. All analyses were performed on an intent-to-treat basis. Interventions Light therapy consisted of receiving a 3-millisecond light flash every 20 seconds during the final 3 hours of sleep (phase 1) or final 2 hours of sleep (phase 2). Sham therapy used an identical device, but delivered 1 minute of light pulses (appearing in 20-second intervals, for a total of 3 pulses) per hour during the final 3 hours of sleep (phase 1) or 2 hours of sleep (phase 2). Light therapy occurred every night during the 4-week intervention. Cognitive behavioral therapy consisted of four 50-minute in-person sessions once per week. Main Outcomes and Measures Primary outcome measures included diary-based sleep times, momentary ratings of evening sleepiness, and subjective measures of sleepiness and sleep quality. Results Among the 102 participants (54 female [52.9%]; mean [SD] age, 15.6 [1.1] years), 72 were enrolled in phase 1 and 30 were enrolled in phase 2. Mixed-effects models revealed that light therapy alone was inadequate in changing the timing of sleep. However, compared with sham therapy plus CBT alone, light therapy plus CBT significantly moved sleep onset a mean (SD) of 50.1 (27.5) minutes earlier and increased nightly total sleep time by a mean (SD) of 43.3 (35.0) minutes. Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale. Conclusions and Relevance This study found that light exposure during sleep, in combination with a brief, motivation-focused CBT intervention, was able to consistently move bedtimes earlier and increase total sleep time in teenagers. This type of passive light intervention in teenagers may lead to novel therapeutic applications. Trial Registration ClinicalTrials.gov identifier: NCT01406691.",2019,"Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale. ","['teenagers', 'Adolescents', 'November 1, 2013, and May 31, 2016, among 102 adolescents enrolled full-time in grades 9 to 12, who expressed difficulty going to bed earlier and waking up early enough, was composed of 2 phases', '102 participants (54 female [52.9%]; mean [SD] age, 15.6 [1.1] years), 72 were enrolled in phase 1 and 30 were enrolled in phase 2', 'teenagers by enabling them to go to sleep earlier than usual']","['4 brief CBT sessions in addition to a modified light or sham therapy', 'light therapy', 'Light therapy plus CBT', 'CBT intervention', 'light or sham therapy', 'light exposure during sleep and cognitive behavioral therapy (CBT', 'Adjunct Cognitive Behavioral Therapy', 'placebo', 'Cognitive behavioral therapy', 'Light Flashes vs Sham Therapy', 'Light therapy', 'passive light intervention']","['total sleep time', 'subjective evening sleepiness', 'Sleep Quality', 'diary-based sleep times, momentary ratings of evening sleepiness, and subjective measures of sleepiness and sleep quality', 'nightly total sleep time', '7-point sleepiness scale', 'bedtime compliance']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085635', 'cui_str': 'Photopsia (disorder)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",102.0,0.0521975,"Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale. ","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Kaplan', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Meital', 'Initials': 'M', 'LastName': 'Mashash', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Rayma', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Batchelder', 'Affiliation': 'Palo Alto University, Palo Alto, California.'}, {'ForeName': 'Lolly', 'Initials': 'L', 'LastName': 'Starr-Glass', 'Affiliation': 'Palo Alto University, Palo Alto, California.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zeitzer', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11944'] 1400,31567579,How Does Perioperative Ketorolac Affect Opioid Consumption and Pain Management After Ankle Fracture Surgery?,"BACKGROUND The investigation of nonnarcotic drug regimens for postoperative pain management is important in addressing the opioid epidemic. NSAIDs can be a powerful adjunct in managing postoperative pain, but the possibility of delayed bone healing is a major concern for orthopaedic surgeons. Our recent retrospective study on ketorolac administration demonstrated that the NSAID is not associated with an increased risk of delayed union or nonunion after ankle fracture surgery. QUESTIONS/PURPOSES To determine whether postoperative ketorolac (1) reduces opioid consumption, (2) improves VAS pain control, and (3) affects fracture healing after open reduction and internal fixation of ankle fractures. METHODS Between August 2016 and December 2017, 128 patients undergoing open reduction and internal fixation of an acute ankle fracture were randomized before surgery via simple randomization to treatment with or without ketorolac. No patients changed treatment regimen groups or opted out of randomization. All other aspects of perioperative care were treated identically. A once-daily survey was distributed via email on postoperative Days 1 to 7. Unblinded participants were asked to report their daily opioid consumption, pain level, and sleep interference using the VAS, and pain frequency using a five-point Likert scale, and side effects with the VAS. For VAS pain, > 20 mm/100 mm on the VAS scale was required to be considered ""improved."" In all, 83% (106 of 128) patients completed all seven postoperative surveys with 14 in the control group and eight in the ketorolac group lost to follow-up. Fifty-six patients were administered ketorolac with opioid medication (treatment group) and 50 were administered opioids alone (control group). Participants were comprised of 42% men (44), and 58% women (62); mean age was 48 years. The treating surgeon assessed clinical healing based on the patient's ability to ambulate comfortably at 12 weeks postoperatively. Radiographic healing was assessed by two fellowship-trained orthopaedic foot and ankle surgeons blinded to the patient's name and time since surgery. The surgeons evaluated randomized standard ankle series (anteroposterior, mortise, and lateral) radiographs for resolution of each fracture line to determine fracture union, with delayed union being defined as fracture lines present on radiographs taken at 12-week postoperative visits. Intention-to-treat analysis was performed. RESULTS Patients in the treatment group consumed a mean of 14 opioid pills, which was less than the mean of 19.3 opioids pills consumed by patients in the control group (p = 0.037). Patients with ketorolac had lower median VAS scores for pain (p < 0.035) postoperatively on postoperative Days 1 and 2 than did control patients. By contrast, patient-reported pain scores and scores for sleep did not convincingly show a benefit to the use of ketorolac. For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961). CONCLUSIONS In this randomized study, adding ketorolac to the postoperative drug regimen decreased the use of opioid medication after open reduction and internal fixation of ankle fractures in the early postoperative period, and there were mixed, small effects on pain reduction. This NSAID is a valuable tool in helping patients manage postoperative pain with less use of narcotic analgesia. However, our study was underpowered to determine the true safety of this drug in terms of fracture healing and side effects and these questions warrant higher-powered randomized study investigation. LEVEL OF EVIDENCE Level I, therapeutic study.",2020,"For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961). ","['Between August 2016 and December 2017, 128 patients undergoing open reduction and internal fixation of an acute ankle fracture', 'Participants were comprised of 42% men (44), and 58% women (62); mean age was 48 years', 'Fifty-six patients were administered']","['postoperative ketorolac', 'ketorolac with opioid medication', 'opioids alone (control group', 'surgery via simple randomization to treatment with or without ketorolac', 'ketorolac']","['VAS scale', 'risk of delayed union or nonunion', 'median VAS scores for pain', 'radiographic healing', 'VAS pain control, and (3) affects fracture healing', 'fracture healing and side effects', 'mean of 14 opioid pills', 'Pain Management', 'clinical healing', 'pain scores and scores for sleep', 'Radiographic healing', 'pain reduction', 'daily opioid consumption, pain level, and sleep interference using the VAS, and pain frequency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",128.0,0.0907682,"For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961). ","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'McDonald', 'Affiliation': 'E. L. McDonald, J. N. Daniel, R. G. Rogero, R. J. Shakked, K. Nicholson, D. I. Pedowitz, S. M. Raikin, B. S. Winters, Rothman Orthopaedic Institute, Philadelphia, PA, USA E. L. McDonald, R. G. Rogero, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA V. Bilolikar, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Daniel', 'Affiliation': ''}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Rogero', 'Affiliation': ''}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Shakked', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nicholson', 'Affiliation': ''}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Pedowitz', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Raikin', 'Affiliation': ''}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bilolikar', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Winters', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000978'] 1401,27825963,Mailed Outreach Program Increases Ultrasound Screening of Patients With Cirrhosis for Hepatocellular Carcinoma.,"BACKGROUND & AIMS Surveillance of patients with cirrhosis increases early detection of hepatocellular carcinoma (HCC) and prolongs survival. However, its effectiveness is limited by underuse, particularly among racial/ethnic minorities and individuals of low socioeconomic status. We compared the effectiveness of mailed outreach strategies, with and without patient navigation, in increasing the numbers of patients with cirrhosis undergoing surveillance for HCC in a racially diverse and socioeconomically disadvantaged cohort. METHODS We performed a prospective study of patients with documented or suspected cirrhosis at a large safety-net health system from December 2014 through March 2016. Patients were assigned randomly (1:1:1) to groups that received mailed invitations for an ultrasound screening examination (n = 600), mailed invitations for an ultrasound screening examination and patient navigation (barrier assessment and motivational education for patients who declined screening; n = 600), or usual care (visit-based screening; n = 600). Patients who did not respond to outreach invitations within 2 weeks received up to 3 reminder telephone calls. The primary outcome was completion of abdominal imaging within 6 months of randomization. RESULTS Baseline characteristics were similar among groups. Cirrhosis was documented, based on International Classification of Diseases, 9th revision, codes, for 79.6% of patients, and suspected, based on noninvasive markers of fibrosis, for 20.4%. In an intent-to-treat analysis, significantly greater proportions of patients who received the mailed invitation and navigation (47.2%) or the mailed invitation alone (44.5%) underwent HCC screening than patients who received usual care (24.3%) (P < .001 for both comparisons). However, screening rates did not differ significantly between outreach the outreach groups (P = .25). The effects of the outreach program were consistent in all subgroups, including Caucasian vs non-Caucasian race, documented vs suspected cirrhosis, Child-Pugh A vs B cirrhosis, and receipt of gastroenterology care. CONCLUSIONS In a prospective study, we found outreach strategies to double the percentage of patients with cirrhosis who underwent ultrasound screening for HCC. However, adding patient navigation to telephone reminders provided no significant additional benefit. ClinicalTrials.gov no: NCT02312817.",2017,"However, screening rates did not differ significantly between outreach the outreach groups (P = .25).","['Patients who did not respond to outreach invitations within 2 weeks received up to 3 reminder telephone calls', 'patients with documented or suspected cirrhosis at a large safety-net health system from December 2014 through March 2016', 'Caucasian vs non-Caucasian race, documented vs suspected cirrhosis, Child', 'With Cirrhosis for Hepatocellular Carcinoma', 'patients with cirrhosis undergoing surveillance for HCC in a racially diverse and socioeconomically disadvantaged cohort', 'patients with cirrhosis increases early detection of hepatocellular carcinoma (HCC) and prolongs survival', 'patients with cirrhosis who underwent ultrasound screening for HCC']","['mailed invitations for an ultrasound screening examination (n\xa0= 600), mailed invitations for an ultrasound screening examination and patient navigation (barrier assessment and motivational education for patients who declined screening; n\xa0= 600), or usual care (visit-based screening', 'mailed outreach strategies, with and without patient navigation']","['completion of abdominal imaging within 6 months of randomization', 'screening rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0007457', 'cui_str': 'Caucasoid Race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",,0.101406,"However, screening rates did not differ significantly between outreach the outreach groups (P = .25).","[{'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Singal', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; Parkland Health and Hospital System, Dallas, Texas; Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: amit.singal@utsouthwestern.edu.'}, {'ForeName': 'Jasmin A', 'Initials': 'JA', 'LastName': 'Tiro', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Marrero', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mejias', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Adamson', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Wendy Pechero', 'Initials': 'WP', 'LastName': 'Bishop', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Parkland Health and Hospital System, Dallas, Texas.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; Parkland Health and Hospital System, Dallas, Texas; Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Gastroenterology,['10.1053/j.gastro.2016.10.042'] 1402,27591991,Role of olanzapine in chemotherapy-induced nausea and vomiting on platinum-based chemotherapy patients: a randomized controlled study.,"PURPOSE Even with the use of modern antiemetic drugs, chemotherapy-induced nausea and vomiting (CINV) is still a cause of great distress to the patients. Olanzapine, primarily marketed as an antipsychotic, was found to reduce nausea and vomiting in some chemotherapy patients. But it was never tested in Indian population with a diverse genetic background. The present study aims to evaluate the role of olanzapine in CINV in patients receiving platinum-based chemotherapy. METHODS The study was a randomized, controlled, assessor-blinded study on 100 chemotherapy-naïve consenting patients receiving any one from cisplatin, carboplatin or oxaliplatin. The control group (n = 50) received palonosetron and dexamethasone in the approved therapeutic dose from the day 1 of chemotherapy. The test group (n = 50) received additional olanzapine 10 mg/day from day 1 for five consecutive days. CINV and quality of life (QoL) were assessed. RESULTS Vomiting was significantly less among the olanzapine-treated patients. Control of delayed emesis was significantly better in this group (complete response among 96 vs. 42 % in the control group, p value <0.0001). Incidence and severity of nausea was significantly less in this group. Failure of anti-CINV measure was 4 % in this group compared to 26 % of the patients of the control group during overall days 1-5. Though sedation was more in these olanzapine-treated patients, there was no dose-limiting adverse event. Quality of life was also better among the olanzapine-treated patients. CONCLUSION Olanzapine was found to be effective as add-on in the control of CINV.",2017,"Control of delayed emesis was significantly better in this group (complete response among 96 vs. 42 % in the control group, p value <0.0001).","['platinum-based chemotherapy patients', 'patients receiving platinum-based chemotherapy', 'Indian population with a diverse genetic background', '100 chemotherapy-naïve consenting patients receiving any one from']","['olanzapine', 'Olanzapine', 'cisplatin, carboplatin or oxaliplatin', 'palonosetron and dexamethasone', 'additional olanzapine']","['CINV and quality of life (QoL', 'nausea and vomiting', 'Failure of anti-CINV measure', 'Quality of life', 'nausea and vomiting (CINV', 'Vomiting', 'delayed emesis', 'Incidence and severity of nausea']","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4042916', 'cui_str': 'Genetic Background'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0034380'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",100.0,0.0282426,"Control of delayed emesis was significantly better in this group (complete response among 96 vs. 42 % in the control group, p value <0.0001).","[{'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Faculty of Pharmacology & Assistant Coordinator of Pharmacovigilance, Department of Pharmacology, Burdwan Medical College, Burdwan, West Bengal, PIN-713102, India. sandipcmcl@gmail.com.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kwatra', 'Affiliation': 'Department of Pharmacology, Christian Medical College, Ludhiana, Punjab, PIN-141008, India.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Alice K', 'Affiliation': 'Department of Radiation Oncology, Christian Medical College, Ludhiana, Punjab, PIN-141008, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Badyal', 'Affiliation': 'Department of Pharmacology, Christian Medical College, Ludhiana, Punjab, PIN-141008, India.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,[] 1403,32492600,Cross-fading motives for simultaneous alcohol and marijuana use: Associations with young adults' use and consequences across days.,"BACKGROUND Many young adults engage in simultaneous alcohol and marijuana (SAM) use so that their effects overlap. Little is known about motivations for dual substance use and associations with use and consequences. This study examined daily-level associations between cross-fading motives and levels of alcohol and marijuana use and consequences. METHODS Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts. Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women). Multilevel models assessed between- and within-person effects of cross-fading motives (i.e., to enhance the effects of marijuana and/or alcohol use by using them simultaneously) on alcohol and marijuana use and consequences, after adjusting for general enhancement, social, coping, and conformity motives and the amount of alcohol and marijuana used that day. RESULTS On 76 % of SAM use days, participants endorsed cross-fading motives (i.e., to enhance the effect of alcohol or marijuana or to get drunk and high at the same time). Having stronger cross-fading motives was associated with greater alcohol use, perceived intoxication, and positive alcohol consequences at the between- and within-person levels. In addition, between-person, individuals who reported stronger cross-fading motives on average reported more negative alcohol consequences and positive marijuana consequences on average. Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. CONCLUSIONS Cross-fading motives were common and varied from day to day. Understanding the motivational context for dual substance use may support future interventions for cross-fading.",2020,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. ","['Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women', 'Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts']",[],['negative alcohol consequences and positive marijuana consequences'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",1049.0,0.0152649,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. ","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, University of Minnesota, 1100 Washington Ave S., Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108077'] 1404,31567611,Pooled Subject-Reported Outcomes From 2 Phase 3 Studies of OnabotulinumtoxinA for Simultaneous Treatment of Forehead and Glabellar Lines.,"BACKGROUND Understanding the subjects' perspective is critical for successfully treating upper facial lines. OBJECTIVE To understand subjects' self-perception and overall satisfaction after onabotulinumtoxinA treatment for forehead and glabellar lines. METHODS This analysis pooled data from two 12-month, pivotal phase 3 studies in which toxin-naive subjects received onabotulinumtoxinA 40 U or placebo for treatment of upper facial lines. OnabotulinumtoxinA was administered as 0.1-mL injections at 10 prespecified sites (frontalis: 20 U; glabellar complex: 20 U). Each study used 3 reliable and validated patient-reported outcome instruments to evaluate subject satisfaction and appearance-related psychological effects: the Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire. In total, data for 865 subjects (608, onabotulinumtoxinA 40 U; 257, placebo) were analyzed. RESULTS Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo. SPA results demonstrated that a significant proportion of subjects in the pooled analysis felt they looked younger after treatment than at baseline (all, p < .0001 vs placebo). CONCLUSION This study demonstrates a high level of treatment satisfaction and significantly improved appearance-related psychological outcomes among toxin-naive subjects after onabotulinumtoxinA 40 U treatment.",2020,"RESULTS Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo.","['toxin-naive subjects after onabotulinumtoxinA 40 U treatment', '865 subjects (608, onabotulinumtoxinA 40 U; 257']","['placebo', 'onabotulinumtoxinA 40 U or placebo', 'OnabotulinumtoxinA']","['appearance-related psychological outcomes', 'Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire']","[{'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",865.0,0.14096,"RESULTS Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ogilvie', 'Affiliation': 'Skin Concept, Munich, Germany.'}, {'ForeName': 'Alexander Z', 'Initials': 'AZ', 'LastName': 'Rivkin', 'Affiliation': 'David Geffen School of Medicine, UCLA, Los Angeles, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dayan', 'Affiliation': 'DeNova Research, Chicago, Illinois.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Yoelin', 'Affiliation': 'Medical Associates Inc., Newport Beach, California.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Larsen', 'Affiliation': 'Peloton Advantage, Parsippany, New Jersey.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Varon', 'Affiliation': 'Health Economics and Outcomes Research, Allergan plc, Irvine, California.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Garcia', 'Affiliation': 'Health Economics and Outcomes Research, Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002153'] 1405,32414425,Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis.,"BACKGROUND In clinical practice, temporary interruption of rheumatoid arthritis (RA) therapy is common for various reasons including side effects, non-compliance, or necessity for surgery. To characterize temporary interruptions of baricitinib and placebo-matched tablets in phase 3 studies of patients with moderate-to-severe rheumatoid arthritis (RA) and describe their impact on efficacy and safety. METHODS During 4 baricitinib phase 3 studies, investigators documented timing, reason, and duration of investigator-initiated temporary interruptions of study drug. In 2 studies, patients recorded RA symptoms in daily diaries for 12 weeks. Post hoc analyses investigated changes in symptom scores during interruptions and resumption of treatment. Interruptions were evaluated for reoccurrence of adverse events or laboratory abnormalities after retreatment. RESULTS Across the placebo-controlled studies, interruptions occurred in larger proportions of baricitinib- (2 mg, 18%; 4 mg, 18%) vs placebo-treated (9%) patients in only one study (bDMARD-inadequate responder patients, RA-BEACON). In the active comparator-controlled studies, the lowest rates of interruption were in the baricitinib monotherapy arm (9%) of RA-BEGIN (vs methotrexate monotherapy or combination therapy), and proportions were similar for baricitinib (10%) and adalimumab (9%) in RA-BEAM. Adverse events were the most common reason for interruption, but their reoccurrence after drug restart was infrequent. Most interruptions lasted ≤ 2 weeks. Daily diaries indicated modest symptom increases during interruption with return to pre-interruption levels or better after resumption. Interruptions had no impact on long-term efficacy outcomes. CONCLUSIONS Consistent with its pharmacologic properties, brief interruptions of baricitinib during phase 3 studies were associated with minor increases in RA symptoms that resolved following retreatment. This analysis provides useful information for clinicians, as temporary interruption of antirheumatic therapy is common in the care of patients with RA. TRIAL REGISTRATION ClinicalTrials.gov; NCT01710358, NCT01711359, NCT01721057, NCT01721044.",2020,"Interruptions had no impact on long-term efficacy outcomes. ","['patients with rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA', 'patients with RA']","['baricitinib', 'baricitinib and placebo-matched tablets', 'adalimumab']","['Adverse events', 'long-term efficacy outcomes', 'efficacy and safety', 'RA symptoms', 'reoccurrence of adverse events or laboratory abnormalities', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.490948,"Interruptions had no impact on long-term efficacy outcomes. ","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Muscoloskeletal Biomedical Research Centre/Chapel Allerton Hospital, Chapeltown Rd, Leeds, LS7 4SA, UK. P.Emery@leeds.ac.uk.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Cardillo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schlichting', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Beattie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Helt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.'}]",Arthritis research & therapy,['10.1186/s13075-020-02199-8'] 1406,31563866,Effect of posterior vitreous detachment on treat-and-extend versus monthly ranibizumab for neovascular age-related macular degeneration.,"AIMS To investigate the impact of posterior vitreous detachment (PVD) on the efficacy of treat-and-extend (T&E) ranibizumab in neovascular age-related macular degeneration. METHODS In a post hoc analysis of a randomised controlled clinical trial, spectral-domain optical coherence tomography images of treatment-naïve patients randomised to receive T&E (n=265) or monthly (n=264) ranibizumab for 12 months were included. Certified, masked graders diagnosed the presence or the absence of complete PVD. The main outcome measures were the mean change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 12, the number of administered ranibizumab injections and the proportion of patients extended to more than 8 weeks. RESULTS At baseline, complete PVD was present in 51% and 56% of patients in the monthly and T&E arms, respectively. Mean change in BCVA at month 12 was +9.0 (PVD) vs +9.5 letters (no PVD, p=0.78) in monthly treated eyes, and +6.0 (PVD) vs +7.5 letters (no PVD, p=0.42) in T&E treated eyes. Conversely, mean change in CRT at month 12 was -174 (PVD) vs -173 µm (no PVD, p=0.98) in the monthly arm, and -175 (PVD) vs -164 µm (no PVD, p=0.58) in the T&E arm. In T&E treated patients, the median number of injections was eight vs nine (p=0.035). 71% of PVD eyes were extended successfully, compared with 55% of eyes without PVD (p=0.005). CONCLUSION PVD was not found to impact functional and anatomical outcomes of T&E ranibizumab therapy. However, patients without a complete PVD required more retreatments and were significantly less likely to be successfully extended. TRIAL REGISTRATION NUMBER NCT01948830.",2020,"In T&E treated patients, the median number of injections was eight vs nine (p=0.035).","['n=265) or monthly (n=264', 'neovascular age-related macular degeneration']","['ranibizumab', 'T&E', 'posterior vitreous detachment (PVD', 'treat-and-extend (T&E) ranibizumab', 'posterior vitreous detachment']","['Mean change in BCVA', 'median number of injections', 'complete PVD', 'mean change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT']","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0423361', 'cui_str': 'Posterior Vitreous Detachment'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",,0.266402,"In T&E treated patients, the median number of injections was eight vs nine (p=0.035).","[{'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Waldstein', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Coulibaly', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Riedl', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sadeghipour', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Bianca S', 'Initials': 'BS', 'LastName': 'Gerendas', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ursula Margarethe', 'Initials': 'UM', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria ursula.schmidt-erfurth@meduniwien.ac.at.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-314661'] 1407,27173787,HCV NS3Ag: a reliable and clinically useful predictor of antiviral outcomes in genotype 1b hepatitis C virus-infected patients.,"Since hepatitis C virus (HCV) non-structural 3 (NS3) protease inhibitor (PI) combined with pegylated interferon/ribavirin (PR) has been approved for chronic HCV genotype (GT) 1b infection, a reliable and clinically useful predictor combining with serum HCV RNA to predict early virologic response, breakthrough, and relapse is important during HCV antiviral treatment. We evaluated the role of HCV NS3 antigen (HCV NS3Ag) on the prediction of virologic response in patients with HCV GT1b during PR or PR/simeprevir (triple) therapy. Three hundred patients were recruited, and HCV RNA and HCV NS3Ag were tested at baseline and weeks 2, 4, 12, 24, 48, and 72. NS3Ag and HCV RNA were significantly related (r(2) = 0.67) in the whole patient selection. The kinetic pattern of HCV RNA and HCV NS3Ag during triple treatment was similar. HCV NS3Ag levels in the triple group closely followed those of HCV RNA; the r(2) values were 0.756 (baseline), 0.837 (2 weeks), 0.989 (4 weeks), and 0.993 (12 weeks), respectively. For patients treated with PR, the positive and negative predictive values (PPVs and NPVs) for viral response were 96.31 % and 67.19 %, respectively, at week 4 by using the decrease of NS3Ag (dHCV NS3Ag) combined with HCV RNA. At week 12, the PPV was similar at 94.16 %, while the NPV reached 87.26 %. The PPV and NPV for the prediction of relapse and breakthrough were 90.6 % and 76.7 %, respectively. HCV NS3Ag is a valuable marker and could be a supplementary predictor of HCV RNA for the prediction of antiviral response, breakthrough, or relapse during HCV antiviral treatment.",2016,"HCV NS3Ag is a valuable marker and could be a supplementary predictor of HCV RNA for the prediction of antiviral response, breakthrough, or relapse during HCV antiviral treatment.","['genotype 1b hepatitis C virus-infected patients', 'patients with HCV GT1b during PR or PR/simeprevir (triple) therapy', 'Three hundred patients were recruited, and HCV RNA and HCV NS3Ag were tested at baseline and weeks 2, 4, 12, 24, 48, and 72']","['pegylated interferon/ribavirin (PR', 'HCV NS3 antigen (HCV NS3Ag', 'HCV NS3Ag']","['HCV NS3Ag levels', 'NS3Ag and HCV RNA', 'relapse and breakthrough', 'positive and negative predictive values (PPVs and NPVs) for viral response', 'kinetic pattern of HCV RNA and HCV NS3Ag', 'virologic response']","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2605855', 'cui_str': 'simeprevir'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",300.0,0.0289423,"HCV NS3Ag is a valuable marker and could be a supplementary predictor of HCV RNA for the prediction of antiviral response, breakthrough, or relapse during HCV antiviral treatment.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': ""Beijing You'an Hospital, Capital Medical University, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': ""Beijing You'an Hospital, Capital Medical University, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Beijing Municipal Liver Diseases Institute, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Beijing You'an Hospital, Capital Medical University, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Beijing You'an Hospital, Capital Medical University, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': ""Beijing Municipal Liver Diseases Institute, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': ""Beijing Municipal Liver Diseases Institute, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': ""Beijing Municipal Liver Diseases Institute, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China. xl811cn@163.com.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Beijing You'an Hospital, Capital Medical University, No. 8 Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, People's Republic of China. chenxydoc@163.com.""}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-016-2653-5'] 1408,32091443,Oral Intake of Lactobacilli Can Be Helpful in Symptomatic Bacterial Vaginosis: A Randomized Clinical Study.,"OBJECTIVE The aim of the study was to explore a role of oral intake of a mixture of 3 Lactobacillus species in recurrence of bacterial vaginosis (BV). MATERIALS AND METHODS A phase 2 randomized parallel group prospective placebo-controlled study conducted at 7 clinical centers enrolled 18- to 45-years-old women with recent symptomatic BV cured with metronidazole. Within 48 hours after completion of metronidazole therapy, eligible women received 1 capsule of the verum (5.4 billion Lactobacillus crispatus LMG S-29995, Lactobacillus brevis, and Lactobacillus acidophilus in proportion of 60%, 20%, and 20%, respectively), or the placebo supplement 2 times daily for the first 7 days and 1 time daily for the next 8 to 120 days. The primary outcome measure was the percentage of recurrence of BV, which was defined as 3 of 4 Amsel criteria plus abnormal vaginal discharge/vulvar odor during 4 months of intake of the test dietary supplement. Differences between the groups were assessed with Z test for proportions. RESULTS One hundred sixty-six women were analyzed in the verum (82 patients) and the placebo group (82 patients). Recurrence of BV was documented in 15 (18.3%) of 82 women in the verum group and 27 (32.1%) of 84 in the placebo group (p = .014). Rates of survival without BV rates were higher in the verum group (Cox F test, p = .018). Both verum and placebo supplements were well tolerated. CONCLUSIONS Oral intake of L. crispatus LMG S-29995, L. brevis, and L. acidophilus can significantly decrease percent of recurrences of BV in recently treated women and prolong time to recurrence of the disease.",2020,"Rates of survival without BV rates were higher in the verum group (Cox F test, p = .018).","['Symptomatic Bacterial Vaginosis', '7 clinical centers enrolled 18- to 45-years-old women with recent symptomatic BV cured with', 'One hundred sixty-six women']","['placebo', 'Lactobacilli', 'mixture of 3 Lactobacillus species', 'metronidazole']","['tolerated', 'Recurrence of BV', 'percentage of recurrence of BV, which was defined as 3 of 4 Amsel criteria plus abnormal vaginal discharge/vulvar odor during 4 months of intake of the test dietary supplement', 'Rates of survival without BV rates', 'recurrence of bacterial vaginosis (BV']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0297096', 'cui_str': 'arsenotriglutathione'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0566986', 'cui_str': 'Vaginal discharge problem (finding)'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}]",166.0,0.341847,"Rates of survival without BV rates were higher in the verum group (Cox F test, p = .018).","[{'ForeName': 'Halyna', 'Initials': 'H', 'LastName': 'Reznichenko', 'Affiliation': 'Zaporizhzhia State Medical University, Zaporizhzhia, Ukraine.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Henyk', 'Affiliation': 'Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Maliuk', 'Affiliation': 'Odessa National Medical University, Odessa, Ukraine.'}, {'ForeName': 'Tetyana', 'Initials': 'T', 'LastName': 'Khyzhnyak', 'Affiliation': 'Lviv Community Emergency Care Clinical Hospital, Lviv, Ukraine.'}, {'ForeName': 'Yevhenia', 'Initials': 'Y', 'LastName': 'Tynna', 'Affiliation': 'Lviv Community Emergency Care Clinical Hospital, Lviv, Ukraine.'}, {'ForeName': 'Ihor', 'Initials': 'I', 'LastName': 'Filipiuk', 'Affiliation': 'The 3rd Lviv Community Clinical Hospital, Lviv, Ukraine.'}, {'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Veresniuk', 'Affiliation': 'Lviv State Center for the Reproductive Health, Lviv, Ukraine.'}, {'ForeName': 'Larysa', 'Initials': 'L', 'LastName': 'Zubrytska', 'Affiliation': 'Medical Center ""MediVit,"" Ternopil, Ukraine.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Quintens', 'Affiliation': 'Vésale Pharma, Éghezée, Belgium.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Richir', 'Affiliation': 'Vésale Pharma, Éghezée, Belgium.'}, {'ForeName': 'Sergiy', 'Initials': 'S', 'LastName': 'Gerasymov', 'Affiliation': 'MedianaStatistics, Lviv, Ukraine.'}]",Journal of lower genital tract disease,['10.1097/LGT.0000000000000518'] 1409,32418801,Primary Care Cluster RCT to Increase Diabetes Prevention Program Referrals.,"INTRODUCTION The Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic. STUDY DESIGN A pragmatic, cluster randomized, mixed-methods study. SETTING/PARTICPANTS Clusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians. INTERVENTION Implementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes. MAIN OUTCOME MEASURES The primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019. RESULTS Study clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful. CONCLUSIONS Intervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.",2020,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","['Diabetes Prevention Program referrals at a primary care clinic', 'Clusters were teams of primary care clinicians from 2 primary care clinics', '2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4']",[],['referral of patients with prediabetes to the institutional Diabetes Prevention Program'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}]",[],"[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",2992.0,0.0201638,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Keck', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky; Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky. Electronic address: james.keck@uky.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Roper', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Hieronymus', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky; University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Alisha R', 'Initials': 'AR', 'LastName': 'Thomas', 'Affiliation': 'Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Zhengyuan', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Fowlkes', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cardarelli', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.008'] 1410,32418659,Extracorporeal Shockwave Therapy and Knee Osteoarthritis: Defining a Placebo Group.,,2020,,['and Knee Osteoarthritis'],"['Extracorporeal Shockwave Therapy', 'Placebo']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.018528,,"[{'ForeName': 'Goksel', 'Initials': 'G', 'LastName': 'Tanigor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Hepguler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.018'] 1411,32416538,"Peer outreach point-of-care testing as a bridge to hepatitis C care for people who inject drugs in Toronto, Canada.","BACKGROUND People who inject drugs have high rates of hepatitis C (HCV) and yet many remain undiagnosed and untreated. HCV treatment guidelines and elimination strategies recommend task-shifting to expand where, and by whom, HCV testing and care is delivered. METHODS A randomized controlled trial design was used to evaluate if point-of-care (POC) HCV antibody testing by peer outreach workers outside of health and social service spaces would improve engagement in HCV care. People with a lifetime history of injection drug use without prior knowledge of HCV antibody status were randomized to receive HCV outreach plus either POC or referral to community-based HCV program for testing as usual. The study was co-designed by people with lived experience of HCV. RESULTS 920 people were approached to participate over 14 weeks. After refusals, withdrawals and removal of duplicates, there were 380 study participants. Outreach took place primarily in public spaces (66%) such as parks, coffee shops and apartment lobbies. Participants reported very high rates of poverty, housing instability and recent injection drug use. Despite being at high risk for HCV, 61% had no history or knowledge of past HCV testing (n = 230). Of those who received a POC test 77/195 (39%) were positive for HCV antibodies. There was no change in rates of engagement in HCV care among those who received the POC (n = 6; 3%) compared to those who did not (n = 5; 3%). CONCLUSION Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing. This improved participants' knowledge of their HCV antibody status, but that knowledge in itself did not lead to any change in participant's subsequent engagement in HCV care. Future work is required to evaluate strategies such as incentives or peer navigators to improve linkage to HCV care after diagnosis.",2020,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"['people with lived experience of HCV', '920 people were approached to participate over 14 weeks', 'by peer outreach workers outside of health and social service spaces', 'People with a lifetime history of injection drug use without prior knowledge of HCV antibody status', 'people who inject drugs in Toronto, Canada']","['HCV outreach plus either POC or referral to community-based HCV program', 'care (POC) HCV antibody testing']",['rates of engagement in HCV care'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]",920.0,0.0380034,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mason', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Guyton', 'Affiliation': 'Sherbourne Health, 333 Sherbourne St, Toronto, ON M5A 2S5, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Lettner', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada; Regent Park Community Health Centre, 465 Dundas St East, Toronto, ON M5A 2B2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'University Health Network, 235 - 200 Elizabeth St, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Powis', 'Affiliation': 'Michael Garron Hospital, 825 Coxwell Ave, Toronto, ON M4C 3E7, Canada. Electronic address: jeff.powis@tehn.ca.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102755'] 1412,31454851,Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial.,"BACKGROUND Acute pancreatitis is a serious complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this noninferiority study was to evaluate the effectiveness of pancreatic duct (PD) stenting plus pharmacological prophylaxis vs. pharmacological prophylaxis alone in the prevention of post-ERCP pancreatitis (PEP) in high risk patients. METHODS In this randomized, controlled, double-blind, noninferiority trial, patients at high risk of developing PEP were randomly allocated to pharmacological prophylaxis (rectal indomethacin, sublingual isosorbide dinitrate, and intravenous hydration with Ringer's lactate) plus PD stenting (group A) or pharmacological prophylaxis alone (group B). The rate and severity of PEP, serum amylase levels, and length of hospital stay after ERCP were assessed. RESULTS During 21 months, a total of 414 patients (mean age 55.5 ± 17.0 years; 60.2 % female) were enrolled (207 in each group). PEP occurred in 59 patients (14.3 %, 95 % confidence interval [CI] 11.1 % - 17.9 %: 26 patients [12.6 %, 95 %CI 8.6 % - 17.6 %] in group A and 33 [15.9 %, 95 %CI 11.4 % - 21.4 %] in group B). There was no significant difference between the two groups in PEP severity ( P  = 0.59), amylase levels after 2 hours ( P  = 0.31) or 24 hours ( P  = 0.08), and length of hospital stay ( P  = 0.07). CONCLUSIONS The study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with PD stenting plus pharmacological prophylaxis in the prevention of PEP in high risk patients.",2019,"There was no significant difference between the two groups in PEP severity ( P  = 0.59), amylase levels after 2 hours ( P  = 0.31) or 24 hours ( P  = 0.08), and length of hospital stay ( P  = 0.07). ","['high risk patients', 'patients at high risk of developing PEP', '414 patients (mean age 55.5\u200a±\u200a17.0 years; 60.2\u200a% female) were enrolled (207 in each group']","['Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis', 'endoscopic retrograde cholangiopancreatography (ERCP', 'pancreatic duct (PD) stenting plus pharmacological prophylaxis vs. pharmacological prophylaxis alone', ""pharmacological prophylaxis (rectal indomethacin, sublingual isosorbide dinitrate, and intravenous hydration with Ringer's lactate) plus PD stenting (group A) or pharmacological prophylaxis alone"", 'PD stenting plus pharmacological prophylaxis']","['length of hospital stay', 'rate and severity of PEP, serum amylase levels, and length of hospital stay after ERCP', 'amylase levels', 'PEP severity', 'PEP']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure (body structure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0022252', 'cui_str': 'Isosorbide Dinitrate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0428349', 'cui_str': 'Serum amylase (pancreatic) measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}]",414.0,0.140876,"There was no significant difference between the two groups in PEP severity ( P  = 0.59), amylase levels after 2 hours ( P  = 0.31) or 24 hours ( P  = 0.08), and length of hospital stay ( P  = 0.07). ","[{'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Sotoudehmanesh', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ali-Asgari', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Khatibian', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mohamadnejad', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Keshtkar', 'Affiliation': 'Department of Health Science Educational Development, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagheri', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Delavari', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Amani', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Vahedi', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Siavosh', 'Initials': 'S', 'LastName': 'Nasseri-Moghaddam', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamad A', 'Initials': 'MA', 'LastName': 'Eloubeidi', 'Affiliation': 'Anniston Digestive Health, Anniston, Alabama, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Malekzadeh', 'Affiliation': 'Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",Endoscopy,['10.1055/a-0977-3119'] 1413,32418809,Effect of transspinal direct current stimulation on afferent pain signalling in humans.,"Anodal transspinal Direct Current Stimulation (tsDCS) has been suggested as a means to treat neuropathic pain by reducing pain signalling/processing and Laser Evoked Potentials (LEPs) likewise as a method to evaluate such reduction. However, results in previous studies are disagreeing. To evaluate these claims using rigorous methodology, LEPs were evoked from hands and feet in healthy volunteers. The N2 potential and three psychophysic parameters (general- and pinprick pain, warmth) were used to evaluate the signalling and appreciation of pain respectively. This was made at three time points; at baseline, directly- and 30 min after low thoracic tsDCS (20 min, 2.5 mA, cathode on shoulder). The study was randomized, cross over, double blinded and placebo controlled. At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (p < 0.05 - p < 0.001). These reductions began during stimulation and became more pronounced during the 30 min after its cessation (p < 0.05 - p < 0.01). The LEP parameter alteration mirroring these changes was latency prolongation (p < 0.05 - p < 0.001) whereas amplitude reductions were in par with placebo stimulation. Similar but less pronounced and only transient (during stimulation, p < 0.05 - p < 0.001) changes, were seen for hand stimulation. The interindividual variation was large. The findings indicate that anodal tsDCS may become a technique to treat neuropathic pain by reducing pain signalling/processing and LEPs likewise a method to evaluate such reduction.",2020,"At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (","['healthy volunteers', 'humans']","['placebo', 'anodal tsDCS', 'Anodal transspinal Direct Current Stimulation (tsDCS', 'transspinal direct current stimulation']","['pain qualities', 'latency prolongation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",,0.0976847,"At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Thordstein', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden. Electronic address: magnus.thordstein@liu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Svantesson', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Rahin', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.04.116'] 1414,32416635,The efficacy and safety of fractional radiofrequency nanoneedle system in the treatment of atrophic acne scars in Asians.,"BACKGROUND Multiple treatment modalities have been developed to treat atrophic acne scars with varying degrees of success. Post-inflammatory hyperpigmentation (PIH) after acne scar treatments remain a major concern in Asian patients. Fractional radiofrequency (FRF) has been used in many dermatological skin conditions including acne scars. AIMS To determine the efficacy and safety of FRF nanoneedle system in the treatment of acne scars in Asians. METHODS This is a prospective, evaluator-blinded study with 25 subjects diagnosed with moderate to severe acne scarring. All subjects received 3 monthly treatments of the FRF nanoneedle system on both cheeks. Primary outcome was the clinical improvement of acne scars graded by 2 blinded dermatologists at baseline, 1-, 3-, and 6-month follow-ups. Objective scar volume analysis was done using ultraviolet A (UVA) light video camera. Subjects' self-assessment, pain score, and adverse events were also recorded. RESULTS Twenty-three out of 25 subjects completed the study and attended all follow-up. Clinical improvement of acne scars was observed as early as 1-month follow-up. Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (P < .005). Majority of the subjects (48%) reported marked improvement in their acne scars. Adverse events such as pain, erythema, burning sensation, edema, scab formation, and PIH were mild and temporary. CONCLUSIONS FRF nanoneedle system is a safe and effective treatment for acne scars in Asians. However, despite the significant changes in the scar volume, caution should be used to avoid excessive coagulation resulting in PIH.",2020,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"['Asian patients', 'acne scars in Asians', '25 subjects diagnosed with moderate to severe acne scarring', 'Twenty-three out of 25 subjects completed the study and attended all follow-up', 'atrophic acne scars in Asians']","['ultraviolet A (UVA) light video camera', 'FRF nanoneedle system', 'fractional radiofrequency nanoneedle system', 'Fractional radiofrequency (FRF']","['clinical improvement of acne scars graded by 2 blinded dermatologists', 'acne scars', 'acne scar volume', ""Subjects' self-assessment, pain score and adverse events"", 'Adverse events such as pain, erythema, burning sensation, edema, scab formation and PIH were mild and temporary', 'efficacy and safety']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0074125', 'cui_str': 'SCAB protocol'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.0167839,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"[{'ForeName': 'Sunatra', 'Initials': 'S', 'LastName': 'Nitayavardhana', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13484'] 1415,30838661,"Concerning ""Triheptanoin vs trioctanoin for long-chain fatty acid oxidation disorders: A double blinded, randomized controlled trial"" by Gillingham et al.",,2019,,[],['Triheptanoin vs trioctanoin'],[],[],"[{'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0077030', 'cui_str': 'glycerol tricaprylate'}]",[],,0.609616,,"[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Shoffner', 'Affiliation': 'Neurology, Biochemical Genetics, Molecular Genetics, Atlanta, GA.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12078'] 1416,30776324,"Cognitive Behavioral Treatment for Acute Posttrauma Distress: A Randomized, Controlled Proof-of-Concept Study Among Hospitalized Adults With Burns.","OBJECTIVE (1) To evaluate the feasibility of conducting a randomized controlled trial (RCT) of the Safety, Meaning, Activation and Resilience Training (SMART) intervention vs nondirective supportive psychotherapy (NDSP) in an acutely hospitalized adult survivor of burn injury sample; and (2) to assess the preliminary effect of SMART on acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and major depressive disorder (MDD) symptom reduction as secondary prevention. DESIGN Proof-of-concept, parallel group RCT design. SETTING Regional burn center. PARTICIPANTS Acutely injured, hospitalized adult survivors of burn injury (N=50) were randomly assigned to SMART (n=28) or nondirective supportive psychotherapy (n=22). Due to dropout and missing data, final sample size was 40, SMART (n=21) and nondirective supportive psychotherapy (n=19). INTERVENTIONS SMART is a manualized, 4-session cognitive behavioral therapy-based psychological intervention targeting ASD, PTSD, and MDD symptoms. NDSP is a manualized, 4-session protocol. MAIN OUTCOME MEASURES Davidson Trauma Scale ([DTS]; diagnostic proxy for ASD and PTSD; clinical cutoff=40, with higher score=higher severity) and the Patient Health Questionnaire-9 ([PHQ-9]; diagnostic proxy for MDD; clinical cutoff=10, with higher score=higher severity) at pretreatment, immediate posttreatment, and 1 month posttreatment. RESULTS At baseline, median DTS scores and PHQ-9 scores were above clinical cutoffs and did not differ across groups. At 1 week and 1 month posttreatment, median DTS and PHQ-9 scores were beneath clinical cutoffs in the SMART group; scores remained above clinical cutoffs in the NDSP group at these time points. CONCLUSIONS It is feasible to conduct an RCT of SMART in hospitalized adult survivors of burn injury. SMART has the potential to yield clinically significant outcomes. Additional studies are needed to replicate and extend these findings.",2020,"At 1 week and 1 month posttreatment, median DTS and PHQ-9 scores were beneath clinical cutoffs in the SMART group; scores remained above clinical cutoffs in the NDSP group at these time points. ","['Hospitalized Adults With Burns', 'hospitalized adult survivors of burn injury', 'Regional burn center', 'Acute Posttrauma Distress', 'Acutely injured, hospitalized adult survivors of burn injury (N=50', 'acutely hospitalized adult survivor of burn injury sample']","['Meaning, Activation and Resilience Training (SMART) intervention vs nondirective supportive psychotherapy (NDSP', 'NDSP', 'SMART', 'Cognitive Behavioral Treatment', 'nondirective supportive psychotherapy']","['median DTS and PHQ-9 scores', 'Davidson Trauma Scale ([DTS]; diagnostic proxy for ASD and PTSD', 'acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and major depressive disorder (MDD) symptom reduction', 'median DTS scores and PHQ-9 scores', 'Patient Health Questionnaire-9']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006418', 'cui_str': 'Burn Centers'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0222045'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0236816', 'cui_str': 'Stress Disorders, Acute'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",50.0,0.0801417,"At 1 week and 1 month posttreatment, median DTS and PHQ-9 scores were beneath clinical cutoffs in the SMART group; scores remained above clinical cutoffs in the NDSP group at these time points. ","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Fauerbach', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: jfauerb1@jhmi.edu.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gehrke', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Shawn T', 'Initials': 'ST', 'LastName': 'Mason', 'Affiliation': 'Johnson and Johnson Health and Wellness Solutions, New Brunswick, New Jersey.'}, {'ForeName': 'Neda F', 'Initials': 'NF', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Milner', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Surgery, Division of Plastics and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Caffrey', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Surgery, Division of Plastics and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2018.11.027'] 1417,31873772,"Etanercept biosimilar (recombinant human tumor necrosis factor-α receptor II: IgG Fc fusion protein) and methotrexate combination therapy in Chinese patients with moderate-to-severe plaque psoriasis: a multicentre, randomized, double-blind, placebo-controlled trial.","Etanercept biosimilar recombinant human tumour necrosis factor-α receptor II: IgG Fc fusion protein (rhTNFR-Fc, trade name Yisaipu) has shown good efficacy in the treatment of moderate-to-severe plaque psoriasis. To compare the efficacy and safety of rhTNFR-Fc plus methotrexate (MTX) and rhTNFR-Fc plus placebo in Chinese patients with moderate-to-severe plaque psoriasis. In this multicentre, randomized, placebo-controlled trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned in a 1:1 ratio to receive rhTNFR-Fc plus MTX or rhTNFR-Fc plus placebo. The primary endpoint was the proportion of patients achieving Psoriasis Area and Severity Index improvement of at least 75% (PASI 75) from baseline at week 24. Adverse events (AEs) were recorded to evaluate safety. Efficacy analysis was performed using the intent-to-treat principle. A total of 466 patients were enrolled and randomly received rhTNFR-Fc plus MTX (combination group, n = 233) or rhTNFR-Fc plus placebo (monotherapy group, n = 233). PASI 75 at week 24 was significantly higher in the combination group than in the monotherapy group (81.86% vs. 65.50%, p < 0.001). Similar results were observed in other PASI improvement scores at week 12 [PASI 75, 62.39% vs. 44.54% (p < 0.001); PASI 50, 87.17% vs. 75.55% (p = 0.001); and PASI 90, 34.07% vs. 18.78% (p < 0.001)] and week 24 [PASI 50, 92.48% vs. 85.59% (p = 0.019); and PASI 90, 64.16% vs. 42.36% (p < 0.001)]. Significantly more patients had a static Physicians' Global Assessment of clear or almost clear in the combination group than in the monotherapy group at week 12 (26.46% vs. 12.50%, p < 0.001) and week 24 (62.38% vs. 40.83%, p < 0.001). The most common AEs in the two groups were upper respiratory tract infection and abnormal liver function. The combination therapy of rhTNFR-Fc plus MTX was an effective therapy for moderate-to-severe plaque psoriasis with an acceptable safety and tolerability profile, indicating that it was feasible and well tolerated for patients.",2020,"PASI 75 at week 24 was significantly higher in the combination group than in the monotherapy group (81.86% vs. 65.50%, p < 0.001).","['Chinese patients with moderate-to-severe plaque psoriasis', 'Etanercept biosimilar recombinant human tumour necrosis factor-α receptor II', '466 patients', 'patients with moderate-to-severe plaque psoriasis']","['rhTNFR-Fc plus MTX', 'IgG Fc fusion protein (rhTNFR-Fc, trade name Yisaipu', 'rhTNFR-Fc plus MTX (combination group, n\u2009=\u2009233) or rhTNFR-Fc plus placebo (monotherapy', 'rhTNFR-Fc plus MTX or rhTNFR-Fc plus placebo', 'rhTNFR-Fc plus methotrexate (MTX) and rhTNFR-Fc plus placebo', 'placebo', 'Etanercept biosimilar (recombinant human tumor necrosis factor-α receptor II: IgG Fc fusion protein) and methotrexate combination therapy']","['proportion of patients achieving Psoriasis Area and Severity Index improvement', 'efficacy and safety', 'Adverse events (AEs', ""static Physicians' Global Assessment of clear or almost clear"", 'PASI improvement scores', 'upper respiratory tract infection and abnormal liver function']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein product'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1448177', 'cui_str': 'tumor necrosis factor-alpha promoter allele-2 protein, human'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}]",466.0,0.297147,"PASI 75 at week 24 was significantly higher in the combination group than in the monotherapy group (81.86% vs. 65.50%, p < 0.001).","[{'ForeName': 'Lun-Fei', 'Initials': 'LF', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, No. 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, No. 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Dermatology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Jin-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong-Zhong', 'Initials': 'HZ', 'LastName': 'Jin', 'Affiliation': 'Department of Dermatology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Xiao-Wen', 'Initials': 'XW', 'LastName': 'Pang', 'Affiliation': ""Department of Dermatology, Chinese People's Liberation Army Air Force General Hospital, Beijing, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, Southwest Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Zai-Pei', 'Initials': 'ZP', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lai', 'Affiliation': 'Department of Dermatology, The Third Affiliated Hospital of Sun Yat-Sen University, Zhongshan, China.'}, {'ForeName': 'Pan-Gen', 'Initials': 'PG', 'LastName': 'Cui', 'Affiliation': 'Department of Dermatology, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of Zhejiang University, Zhejiang, China.'}, {'ForeName': 'Cheng-Zhi', 'Initials': 'CZ', 'LastName': 'Lyu', 'Affiliation': 'Department of Dermatology, Dalian Dermatosis Hospital, Dalian, China.'}, {'ForeName': 'Yu-Zhen', 'Initials': 'YZ', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Dermatology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Hong-Fu', 'Initials': 'HF', 'LastName': 'Xie', 'Affiliation': 'Department of Dermatology, XiangYa Hospital Central South University, Changsha, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, The University of Hong Kong-Shen Zhen Hospital, Shenzhen, China.'}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Shi', 'Affiliation': ""Department of Dermatology, Tenth People's Hospital of Tongj University, Shanghai, China.""}, {'ForeName': 'Nai-Qing', 'Initials': 'NQ', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, College of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, College of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, No. 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China. minz@zju.edu.cn.'}]",Archives of dermatological research,['10.1007/s00403-019-02024-6'] 1418,32419119,The Effectiveness and Cost-effectiveness of a Parenting Intervention Integrated with Primary Health Care on Early Childhood Development: a Cluster-Randomized Controlled Trial.,"Developing countries require interventions that can sustainably improve early childhood development (ECD) at scale because hundreds of millions of children are at risk of poor development. This study examined the effectiveness and cost-effectiveness of a parenting intervention integrated with primary health care in terms of ECD. A cluster-randomized controlled trial was conducted in 20 urban communities in China, with 82 and 86 children aged 1-2 months enrolled in the intervention and control groups, respectively, and 71 and 69 children, respectively, followed to 14 months of age. All children in both groups received routine primary health care services. Intervention caregivers received a parenting pamphlet and two parenting training sessions during well-child clinic visits; those with children with suspected developmental delay received additional parenting guidance by telephone. Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention. The intervention cost per child was $50.87, and the costs for increasing the communication, fine motor, and overall ASQ-C scores by one SD were $195.65, $267.74, and $203.48, respectively. Our findings indicate that the integration of a parenting intervention with existing primary health care is a cost-effective way to improve ECD.",2020,"Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention.","['20 urban communities in China, with 82 and 86 children aged 1-2\xa0months enrolled in the intervention and control groups, respectively, and 71 and 69 children, respectively, followed to 14\xa0months of age']","['parenting pamphlet and two parenting training sessions during well-child clinic visits; those with children with suspected developmental delay received additional parenting guidance by telephone', 'routine primary health care services', 'Parenting Intervention Integrated with Primary Health Care', 'parenting intervention integrated with primary health care']","['costs for increasing the communication, fine motor, and overall ASQ-C scores', 'Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C', 'fine motor', 'effectiveness and cost-effectiveness', 'Effectiveness and Cost-effectiveness']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.116487,"Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention.","[{'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, 168 Litang Road, Changping District, Beijing, 102218, China. lixuejun0627@163.com.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies (CCHDS), Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Jingxu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China. xlwang@bjmu.edu.cn.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01126-2'] 1419,31847717,Duration of treatment with inhaled corticosteroids in nonasthmatic eosinophilic bronchitis: a randomized open label trial.,"BACKGROUND Nonasthmatic eosinophilic bronchitis (NAEB) responds well to inhaled corticosteroids (ICS), while recurrence is common after discontinuing treatment. There are no data available to show whether treatment duration of ICS in patients with NAEB is related to recurrence. We aim to evaluate the effect of different duration of treatment with ICS on relapse of NAEB. METHODS A total of 101 patients with NAEB were recruited to the open label, randomized, parallel-group trial. Patients were randomized to receive 1-month, 2-month, or 4-month treatment with inhaled budesonide (200 μg, twice daily). Sputum induction, cough visual analogue scale (VAS), and cough symptom score (CSS) were conducted at baseline and after completion of treatment. The patients were followed up for 1 year after treatment. The primary outcome was the relapse rate of NAEB in 1 year. RESULTS ICS significantly decreased cough VAS, CSS, and sputum eosinophilia among these groups. There were no statistically significant between-group differences in cough VAS, CSS scores, and sputum eosinophil counts at the end of treatment, and no significant between-group differences in those changes from baseline to post-treatment. Significantly, more participants in the 1-month treatment group experienced a recurring episode of NAEB than those in the 3-month treatment group (41.9% versus 12.0%, p  = 0.0137) at 1-year follow-up. The 2-month treatment group showed a lower tendency, with a relapse rate of 20.0% ( p  = 0.0644). CONCLUSIONS Our results suggest that inhaled corticosteroids should be administrated for at least 2 months to reduce the relapse of NAEB. CLINICAL TRIAL REGISTRATION The study was registered on ClinicalTrials.gov (NCT02002715). The reviews of this paper are available via the supplemental material section.",2019,"There were no statistically significant between-group differences in cough VAS, CSS scores, and sputum eosinophil counts at the end of treatment, and no significant between-group differences in those changes from baseline to post-treatment.","['nonasthmatic eosinophilic bronchitis', '101 patients with NAEB', 'patients with NAEB']","['ICS', 'inhaled corticosteroids', 'inhaled budesonide']","['relapse rate', 'cough VAS, CSS, and sputum eosinophilia', 'relapse rate of NAEB', 'recurring episode of NAEB', 'relapse of NAEB', 'cough VAS, CSS scores, and sputum eosinophil counts', 'Sputum induction, cough visual analogue scale (VAS), and cough symptom score (CSS']","[{'cui': 'C1698398', 'cui_str': 'Eosinophilic bronchitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",101.0,0.170444,"There were no statistically significant between-group differences in cough VAS, CSS scores, and sputum eosinophil counts at the end of treatment, and no significant between-group differences in those changes from baseline to post-treatment.","[{'ForeName': 'Wenzhi', 'Initials': 'W', 'LastName': 'Zhan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Jiaman', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Baojuan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Qiaoli', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.'}, {'ForeName': 'Kefang', 'Initials': 'K', 'LastName': 'Lai', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, Guangdong, P. R. China.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466619891520'] 1420,32417537,Dual X-ray absorptiometry has limited utility in detecting bone pathology in children with hypophosphatasia: A pooled post hoc analysis of asfotase alfa clinical trial data.,"Asfotase alfa is an enzyme replacement therapy approved for treatment of patients with pediatric-onset hypophosphatasia (HPP), a rare, inherited, systemic disease causing impaired skeletal mineralization, short stature, and reduced physical function in children. The role of dual X-ray absorptiometry (DXA) in the assessment of children with HPP has been insufficiently explored. This post hoc analysis included pooled DXA data from 2 open-label, multicenter studies in 19 children with HPP. The study population was aged ≥5 to <18 years and had received asfotase alfa for ≤6.6 years at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7]; treatment duration: 6.3 y [range: 0.1-6.6]. Baseline height Z-scores indicated short stature (median [min, max]: -1.26 [-6.6, 0]); mean [SD]: -2.30 [1.97]), thus requiring height adjustment of DXA Z-scores. At Baseline, few patients had height-adjusted bone mineral density (BMD ht ) Z-scores of -2 or less for whole body (n = 3) or lumbar spine (n = 5). In treated patients, mean whole body and lumbar spine BMD ht Z-scores did not change over time, but whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores increased significantly from Baseline to Last Assessment (P ≤ 0.0056). Improvements in Radiographic Global Impression of Change (RGI-C) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores. Improvements in Rickets Severity Score (RSS) correlated significantly with increases in lumbar spine BMD ht Z-scores and whole body BMC ht Z-scores (P < 0.05). No significant correlations were observed between any DXA and bone histomorphometry measure. These findings suggest that DXA BMD Z-scores, which are commonly used in clinical practice, have limited utility in assessing deficient bone mineralization in patients with HPP. Although BMC ht Z-scores increased significantly over time with asfotase alfa therapy, the lack of significant changes in more than one DXA parameter suggests that this tool may not be useful in everyday clinical practice. Furthermore, the use of BMC as an independent metric is not typical or recommended by guidelines. Complementary measures, such as skeletal radiographs supplemented with age-appropriate functional assessments, should be considered.",2020,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores.,"['patients with pediatric-onset hypophosphatasia (HPP', 'children with hypophosphatasia', 'The study population was aged ≥5 to <18\u202fyears and had received asfotase alfa for ≤6.6\u202fyears at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6', '19 children with HPP', 'patients with HPP', 'children with HPP']","['dual X-ray absorptiometry (DXA', 'Dual X-ray absorptiometry']","['BMC ht Z-scores', 'whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores', 'mean [SD', 'Rickets Severity Score (RSS', 'mean whole body and lumbar spine BMD ht Z-scores', 'Radiographic Global Impression of Change (RGIC) scale scores', 'DXA and bone histomorphometry measure', 'lumbar spine BMD ht Z-scores and whole body', 'height-adjusted bone mineral density (BMD ht ) Z-scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.0447297,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores.,"[{'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Vanderbilt University, Village at Vanderbilt, 1500 21st Ave South, Suite 1514, Nashville, TN 37212, USA. Electronic address: jill.h.simmons@vumc.org.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Rush', 'Affiliation': ""Department of Pediatrics, Children's Mercy Kansas City, Adele Hall Campus, 2401 Gillham Rd, Kansas City, MO 64108, USA; University of Missouri - Kansas City School of Medicine, 2411 Holmes St, Kansas City, MO 64108, USA; University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: etrush@cmh.edu.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Petryk', 'Affiliation': 'Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210, USA. Electronic address: Anna.Petryk@alexion.com.'}, {'ForeName': 'Shanggen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Clinical Development Services-Corporate, Covance, Inc., 210 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: shanggen.zhou@covance.com.'}, {'ForeName': 'Gabriel Á', 'Initials': 'GÁ', 'LastName': 'Martos-Moreno', 'Affiliation': 'Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, IIS La Princesa, Av. de Menéndez Pelayo, 65, 28009 Madrid, Spain; Department of Pediatrics, Universidad Autónoma de Madrid, Calle Arzobispo Morcillo, 4, 28029 Madrid, Spain; CIBERobn, Instituto de Salud Carlos III, C/ Sinesio Delgado, 4, 28029 Madrid, Spain. Electronic address: gabrielangelmartos@yahoo.es.'}]",Bone,['10.1016/j.bone.2020.115413'] 1421,32424253,Closed-loop digital meditation for neurocognitive and behavioral development in adolescents with childhood neglect.,"Adverse childhood experiences are linked to poor attentive behaviors during adolescence, as well as increased risk for mental health disorders in adults. However, no study has yet tested targeted interventions to optimize neurocognitive processes in this population. Here, we investigated closed-loop digital interventions in a double-blind randomized controlled study in adolescents with childhood neglect, and evaluated the outcomes using multimodal assessments of neuroimaging, cognitive, behavioral, and academic evaluations. In the primary neuroimaging results, we demonstrate that a closed-loop digital meditation intervention can strengthen functional connectivity of the dorsal anterior cingulate cortex (dACC) in the cingulo-opercular network, which is critically developing during the adolescent period. Second, this intervention enhanced sustained attention and interference-resolution abilities, and also reduced behavioral hyperactivity at a 1-year follow-up. Superior academic performance was additionally observed in adolescents who underwent the digital meditation intervention. Finally, changes in dACC functional connectivity significantly correlated with improvements in sustained attention, hyperactivity, and academic performance. This first study demonstrates that closed-loop digital meditation practice can facilitate development of important aspects of neurocognition and real-life behaviors in adolescents with early childhood neglect.",2020,This first study demonstrates that closed-loop digital meditation practice can facilitate development of important aspects of neurocognition and real-life behaviors in adolescents with early childhood neglect.,"['mental health disorders in adults', 'adolescents with early childhood neglect', 'adolescents with childhood neglect']","['closed-loop digital interventions', 'closed-loop digital meditation intervention', 'digital meditation intervention', 'Closed-loop digital meditation']","['dACC functional connectivity', 'Superior academic performance', 'sustained attention, hyperactivity, and academic performance', 'behavioral hyperactivity', 'sustained attention and interference-resolution abilities']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0298422,This first study demonstrates that closed-loop digital meditation practice can facilitate development of important aspects of neurocognition and real-life behaviors in adolescents with early childhood neglect.,"[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA. jymishra@ucsd.edu.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sagar', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Parveen', 'Affiliation': 'Department of Pediatric Neurology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Kumaran', 'Affiliation': 'Department of Nuclear Magnetic Resonance, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Modi', 'Affiliation': 'Udayan Care, New Delhi, India.'}, {'ForeName': 'Vojislav', 'Initials': 'V', 'LastName': 'Maric', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}]",Translational psychiatry,['10.1038/s41398-020-0820-z'] 1422,31057139,"Personally salient, emotionally negative task contexts provoke goal neglect in depression.","BACKGROUND Goal neglect refers to a dissociation between intended and actual action. Although commonly associated with frontal brain damage, this phenomenon is also characteristic of clinical depression. To date, tests of goal neglect typically require individuals to switch between subtasks populated with neutral stimuli. This study examined the impact of affective and personally salient stimulus contexts on goal neglect in clinical depression. METHODS Participants were randomly allocated to either positively or negatively-valenced versions of the Affective Six Elements Test (A-SET). We hypothesised that depressed individuals (n = 30) would exhibit an overall impairment in A-SET performance by neglecting entire subtasks and allocating suboptimal time to each task, relative to never-depressed peers (n = 30), with effects being strongest for the negatively-valenced version. RESULTS Findings showed that depressed individuals exhibited specific deficits, relative to controls on these measures in the negative A-SET only, with a magnitude comparable to that found in brain injured patients. CONCLUSIONS Individuals with depression are impaired in their ability to monitor performance and implement strategies that are optimal for the purpose of pursuing an overarching goal when the task context is negatively-valenced. Potential mechanisms are discussed.",2020,"RESULTS Findings showed that depressed individuals exhibited specific deficits, relative to controls on these measures in the negative A-SET only, with a magnitude comparable to that found in brain injured patients. ",['Participants'],[],['specific deficits'],[],[],"[{'cui': 'C0205369', 'cui_str': 'Specified'}]",30.0,0.0246317,"RESULTS Findings showed that depressed individuals exhibited specific deficits, relative to controls on these measures in the negative A-SET only, with a magnitude comparable to that found in brain injured patients. ","[{'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Dahm', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Golden', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Manly', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dalgleish', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}]",Psychological medicine,['10.1017/S0033291719000886'] 1423,32417348,Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy. METHODS Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP). RESULTS 188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found. CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.",2020,"CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: yungan.tao@gustaveroussy.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; INSERM 1018, Villefjuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France; Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France; Centre francois Baclesse, Caen, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes, France; Institut du Cancer de Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France; Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021'] 1424,29304083,Combined evaluation of sexually transmitted infections in HIV-infected pregnant women and infant HIV transmission.,"BACKGROUND Sexually transmitted infections (STIs) including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Treponema pallidum (TP), and cytomegalovirus (CMV) may lead to adverse pregnancy and infant outcomes. The role of combined maternal STIs in HIV mother-to-child transmission (MTCT) was evaluated in mother-infant pairs from NICHD HPTN 040. METHODOLOGY Urine samples from HIV-infected pregnant women during labor were tested by polymerase chain reaction (PCR) for CT, NG, and CMV. Infant HIV infection was determined by serial HIV DNA PCR testing. Maternal syphilis was tested by VDRL and confirmatory treponemal antibodies. RESULTS A total of 899 mother-infant pairs were evaluated. Over 30% had at least one of the following infections (TP, CT, NG, and/or CMV) detected at the time of delivery. High rates of TP (8.7%), CT (17.8%), NG (4%), and CMV (6.3%) were observed. HIV MTCT was 9.1% (n = 82 infants). HIV MTCT was 12.5%, 10.3%, 11.1%, and 26.3% among infants born to women with CT, TP, NG or CMV respectively. Forty-two percent of HIV-infected infants were born to women with at least one of these 4 infections. Women with these infections were nearly twice as likely to have an HIV-infected infant (aOR 1.9, 95% CI 1.1-3.0), particularly those with 2 STIs (aOR 3.4, 95% CI 1.5-7.7). Individually, maternal CMV (aOR 4.4 1.5-13.0) and infant congenital CMV (OR 4.1, 95% CI 2.2-7.8) but not other STIs (TP, CT, or NG) were associated with an increased risk of HIV MTCT. CONCLUSION HIV-infected pregnant women identified during labor are at high risk for STIs. Co-infection with STIs including CMV nearly doubles HIV MTCT risk. CMV infection appears to confer the largest risk of HIV MTCT. TRIAL REGISTRATION NCT00099359.",2018,"High rates of TP (8.7%), CT (17.8%), NG (4%), and CMV (6.3%) were observed.","['Urine samples from HIV-infected pregnant women during labor', 'HIV-infected pregnant women and infant HIV transmission', 'A total of 899 mother-infant pairs', 'HIV mother-to-child transmission (MTCT) was evaluated in mother-infant pairs from NICHD HPTN 040']",['combined maternal STIs'],"['High rates of TP', 'Maternal syphilis', 'Infant HIV infection', 'risk of HIV MTCT', 'maternal CMV', 'infant congenital CMV (OR']","[{'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0282474', 'cui_str': 'Mother-to-Child Transmission'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0036916', 'cui_str': 'STDs'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0039128', 'cui_str': 'Great Pox'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}]",899.0,0.0901702,"High rates of TP (8.7%), CT (17.8%), NG (4%), and CMV (6.3%) were observed.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Adachi', 'Affiliation': 'David Geffen UCLA School of Medicine, Los Angeles, CA, United States of America.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Westat, Rockville, MD, United States of America.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Yeganeh', 'Affiliation': 'David Geffen UCLA School of Medicine, Los Angeles, CA, United States of America.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Camarca', 'Affiliation': 'Westat, Rockville, MD, United States of America.'}, {'ForeName': 'Mariza G', 'Initials': 'MG', 'LastName': 'Morgado', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'D Heather', 'Initials': 'DH', 'LastName': 'Watts', 'Affiliation': 'Office of the Global AIDS Coordinator, U.S. Department of State, Washington D.C., United States of America.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Mofenson', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington D.C., United States of America.'}, {'ForeName': 'Valdilea G', 'Initials': 'VG', 'LastName': 'Veloso', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Jose Henrique', 'Initials': 'JH', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, RJ, Brazil.'}, {'ForeName': 'Esau', 'Initials': 'E', 'LastName': 'Joao', 'Affiliation': 'Hospital Federal dos Servidores do Estado, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': 'SAMRC and Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Stellenbosch University/Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Conceicao, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Hospital Femina, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Kreitchmann', 'Affiliation': 'Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Marisa M', 'Initials': 'MM', 'LastName': 'Mussi-Pinhata', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Ceriotto', 'Affiliation': 'Foundation for Maternal and Infant Health (FUNDASAMIN), Buenos Aires, Argentina.'}, {'ForeName': 'Daisy Maria', 'Initials': 'DM', 'LastName': 'Machado', 'Affiliation': 'Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Yvonne J', 'Initials': 'YJ', 'LastName': 'Bryson', 'Affiliation': 'David Geffen UCLA School of Medicine, Los Angeles, CA, United States of America.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moye', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Klausner', 'Affiliation': 'David Geffen UCLA School of Medicine, Los Angeles, CA, United States of America.'}, {'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Bristow', 'Affiliation': 'UCSD School of Medicine, La Jolla, CA, United States of America.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Dickover', 'Affiliation': 'UC Davis School of Medicine, Davis, CA, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nielsen-Saines', 'Affiliation': 'David Geffen UCLA School of Medicine, Los Angeles, CA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0189851'] 1425,26265201,Impact of Risk Assessment and Tailored versus Nontailored Risk Information on Colorectal Cancer Testing in Primary Care: A Randomized Controlled Trial.,"BACKGROUND Colorectal cancer screening is effective but underused. Guidelines for which tests are recommended and at what intervals depend on specific risks. We developed a tablet-based Cancer Risk Intake System (CRIS) that asks questions about risk prior to appointments and generates tailored printouts for patients and physicians summarizing and matching risk factors with guideline-based recommendations. METHODS Randomized controlled trial among patients who: (i) used CRIS and they and their physicians received tailored printouts; (ii) used CRIS to answer questions but received standard information about cancer screening while their physicians received a standard electronic chart prompt indicating they were age-eligible but not currently adherent for colorectal cancer screening; or (iii) comprised a no-contact group that neither used CRIS nor received any information while their physicians received the standard prompt. Participation in testing was assessed via electronic medical record at 12 months. RESULTS Participation in any colorectal cancer testing was three times higher for those who used the CRIS and received any printed materials, compared with no-contact controls (47% vs. 16%; P < 0.0001). Among CRIS users ages 50 and older, participation in any testing was higher in the tailored group (53% vs. 44%, P = 0.023). CONCLUSION Use of CRIS and receipt of any information facilitated participation in testing. There was more testing participation in the CRIS-tailored than nontailored group. IMPACT Asking patients questions about their specific risk factors and giving them and their providers information just prior to an appointment may increase participation in colorectal cancer testing. Tailoring the information has some added benefit.",2015,"RESULTS Participation in any colorectal cancer testing was three times higher for those who used the CRIS and received any printed materials, compared with no-contact controls (47% vs. 16%; P < 0.0001).","['patients who: (i) used', 'Colorectal Cancer Testing in Primary Care']","['CRIS and they and their physicians received tailored printouts; (ii) used CRIS to answer questions but received standard information about cancer screening while their physicians received a standard electronic chart prompt indicating they were age-eligible but not currently adherent for colorectal cancer screening; or (iii) comprised a no-contact group that neither used CRIS nor received any information while their physicians received the standard prompt', 'Risk Assessment and Tailored versus Nontailored Risk Information', 'tablet-based Cancer Risk Intake System (CRIS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer (procedure)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],,0.0409229,"RESULTS Participation in any colorectal cancer testing was three times higher for those who used the CRIS and received any printed materials, compared with no-contact controls (47% vs. 16%; P < 0.0001).","[{'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Simmons Cancer Center, The University of Texas Southwestern Medical Center, Dallas, Texas. Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas. celette.skinner@utsouthwestern.edu.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Simmons Cancer Center, The University of Texas Southwestern Medical Center, Dallas, Texas. Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas. Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Wendy Pechero', 'Initials': 'WP', 'LastName': 'Bishop', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Simmons Cancer Center, The University of Texas Southwestern Medical Center, Dallas, Texas. Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Veterans Affairs San Diego Healthcare System, Division of Gastroenterology, Department of Internal Medicine, and the Moores Cancer Center, University of California San Diego, San Diego, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Durham, North Carolina.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Morrow', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Julka', 'Affiliation': 'Department of Family and Community Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Sanders', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Marks', 'Affiliation': 'Department of Clinical Sciences, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'Indiana University School of Nursing and Simon Cancer Center, Indianapolis, Indiana.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-15-0122'] 1426,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL). MATERIALS AND METHODS Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week). RESULTS The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found. CONCLUSION No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020'] 1427,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD). METHODS This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks. RESULTS Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo. CONCLUSIONS Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878'] 1428,32417770,"The MARBLE Study Protocol: Modulating ApoE Signaling to Reduce Brain Inflammation, DeLirium, and PostopErative Cognitive Dysfunction.","BACKGROUND Perioperative neurocognitive disorders (PND) are common complications in older adults associated with increased 1-year mortality and long-term cognitive decline. One risk factor for worsened long-term postoperative cognitive trajectory is the Alzheimer's disease (AD) genetic risk factor APOE4. APOE4 is thought to elevate AD risk partly by increasing neuroinflammation, which is also a theorized mechanism for PND. Yet, it is unclear whether modulating apoE4 protein signaling in older surgical patients would reduce PND risk or severity. OBJECTIVE MARBLE is a randomized, blinded, placebo-controlled phase II sequential dose escalation trial designed to evaluate perioperative administration of an apoE mimetic peptide drug, CN-105, in older adults (age≥60 years). The primary aim is evaluating the safety of CN-105 administration, as measured by adverse event rates in CN-105 versus placebo-treated patients. Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity. METHODS 201 patients undergoing non-cardiac, non-neurological surgery will be randomized to control or CN-105 treatment groups and receive placebo or drug before and every six hours after surgery, for up to three days after surgery. Chart reviews, pre- and postoperative cognitive testing, delirium screening, and blood and CSF analyses will be performed to examine effects of CN-105 on perioperative adverse event rates, cognition, and neuroinflammation. Trial results will be disseminated by presentations at conferences and peer-reviewed publications. CONCLUSION MARBLE is a transdisciplinary study designed to measure CN-105 safety and efficacy for preventing PND in older adults and to provide insight into the pathogenesis of these geriatric syndromes.",2020,"Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity. ","['older adults', 'treated patients', '201 patients undergoing non-cardiac, non-neurological surgery', 'older surgical patients', ""Alzheimer's disease (AD) genetic risk factor"", 'older adults (age≥60 years']","['CN-105 versus placebo', 'CN-105', 'control or CN-105 treatment groups and receive drug or placebo', 'placebo']","['perioperative adverse event rates, cognition, and neuroinflammation', '1-year mortality', 'adverse event rates', 'postoperative neuroinflammation and PND severity', 'Brain Inflammation, DeLirium, and PostopErative Cognitive Dysfunction', 'CN-105 safety and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",201.0,0.0801323,"Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity. ","[{'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'VanDusen', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sarada', 'Initials': 'S', 'LastName': 'Eleswarpu', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Eugene W', 'Initials': 'EW', 'LastName': 'Moretti', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Devinney', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Crabtree', 'Affiliation': 'Duke Office of Clinical Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Laskowitz', 'Affiliation': 'Department of Neurology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Marty G', 'Initials': 'MG', 'LastName': 'Woldorff', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Roberts', 'Affiliation': 'Center for Cognitive Neuroscience, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Whittle', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Browndyke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cooter', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Oke', 'Initials': 'O', 'LastName': 'Anakwenze', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bolognesi', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Easley', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Ferrandino', 'Affiliation': 'Department of Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Jiranek', 'Affiliation': 'Department of Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191185'] 1429,32416996,"Restricted versus liberal intraoperative benzodiazepine use in cardiac anaesthesia for reducing delirium (B-Free Pilot): a pilot, multicentre, randomised, cluster crossover trial.","BACKGROUND Delirium is common after cardiac surgery and is associated with adverse outcomes. Perioperative benzodiazepine use is associated with delirium and is common during cardiac surgery, which may increase the risk of postoperative delirium. We undertook a pilot study to inform the feasibility of a large randomised cluster crossover trial examining whether an institutional policy of restricted benzodiazepine administration during cardiac surgery (compared with liberal administration) would reduce delirium. METHODS We conducted a two-centre, pilot, randomised cluster crossover trial with four 4 week crossover periods. Each centre was randomised to a policy of restricted or liberal use, and then alternated between the two policies during the remaining three periods. Our feasibility outcomes were adherence to each policy (goal ≥80%) and outcome assessment (one delirium assessment per day in the ICU in ≥90% of participants). We also evaluated the incidence of intraoperative awareness in one site using serial Brice questionnaires. RESULTS Of 800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium. Of these, 355/389 (91.3%) received benzodiazepines during the liberal benzodiazepine periods and 363/411 (88.3%) did not receive benzodiazepines during the restricted benzodiazepine periods. Amongst the 800 patients, 740 (92.5%) had ≥1 postoperative delirium assessment per day in the ICU. Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness. CONCLUSIONS This pilot study demonstrates the feasibility of a large, multicentre, randomised, cluster crossover trial examining whether an institutional policy of restricted vs liberal benzodiazepine use during cardiac surgery will reduce postoperative delirium. CLINICAL TRIAL REGISTRATION NCT03053869.",2020,"Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness. ","['521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted', '800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium']","['benzodiazepines', 'benzodiazepine', 'liberal intraoperative benzodiazepine']",['postoperative delirium assessment'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0919727', 'cui_str': 'Awareness During Anesthesia'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",800.0,0.304096,"Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness. ","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spence', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada; Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada. Electronic address: Jessica.Spence@phri.ca.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Belley-Côté', 'Affiliation': 'Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada; Department of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Shun Fu', 'Initials': 'SF', 'LastName': 'Lee', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': 'Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Surgery (Cardiac Surgery), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Bangdiwala', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Syed', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Sarkaria', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacIsaac', 'Affiliation': 'School of Medicine, Faculty of Medicine, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lengyel', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Um', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'McIntyre', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Morvarid', 'Initials': 'M', 'LastName': 'Kavosh', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fast', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': 'Department of Critical Care, University of Manitoba, Winnipeg, MB, Canada; Department of Surgery (Cardiac Surgery), University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lamy', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Surgery (Cardiac Surgery), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.03.030'] 1430,31170973,Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment.,"BACKGROUND Lifestyle interventions regularly rely on study staff to implement the intervention and collect outcomes data directly from study participants. This study describes the experiences of project staff in two randomized controlled trials of a postpartum lifestyle intervention to reduce risk factors for type 2 diabetes in Latinas. Latinas are the fastest growing minority group in the U.S. and have the highest rates of type 2 diabetes after a diagnosis of gestational diabetes mellitus. The challenges of implementing lifestyle interventions for postpartum women have been poorly documented. METHODS A qualitative focus group was conducted with eight staff members (five health educators and three health interviewers) involved in Proyecto Mamá and Estudio Parto. The discussion was audio recorded, transcribed, and coded in NVivo. Focus group topics included: 1) participant recruitment, 2) participant retention, 3) implementation of the lifestyle intervention, 4) assessment of behavior change, 5) overall challenges and rewarding aspects of the trial, and 6) recommended changes for future trials. RESULTS Key themes emerged regarding enabling factors and barriers to implementing a lifestyle intervention in postpartum Latinas. Enabling factors included: a) the staff's belief in the importance of the intervention, b) opportunities associated with the longitudinal nature of the trial, c) belief that the staff could empower participants to make behavior change, d) benefits of flexible intervention sessions, and e) connection with participants due to shared cultural backgrounds. Barriers included: a) participant stressors: home, food, and financial insecurity, b) low health literacy, c) issues related to recent immigration to the continental U.S., d) handling participant resistance to behavior change, e) involvement of family members in assessment visits, f) limitations of the assessment tools, and g) time limitations. CONCLUSIONS Findings highlight the challenging contexts that many study participants face, and shed light on the potentially influential role of health educators and interviewers in intervention implementation and data collection. Specific recommendations are made for strategies to improve adherence to diabetes prevention programs in postpartum underserved and minority populations in this challenging, transitional period of life. TRIAL REGISTRATION NCT01679210 . Registered 5 September 2012; NCT01868230 . Registered 4 June 2013.",2019,A qualitative focus group was conducted with eight staff members (five health educators and three health interviewers) involved in Proyecto Mamá and Estudio Parto.,"['with participants due to shared cultural backgrounds', 'Latinas', 'eight staff members (five health educators and three health interviewers) involved in Proyecto Mamá and Estudio Parto', 'type 2 diabetes in Latinas', 'postpartum women']","['postpartum lifestyle intervention', 'flexible intervention sessions, and e) connection', 'postpartum diabetes prevention program']","['food, and financial insecurity, b) low health literacy, c) issues related to recent immigration to the continental U.S., d) handling participant resistance to behavior change, e) involvement of family members in assessment visits, f) limitations of the assessment tools, and g) time limitations']","[{'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0010447', 'cui_str': 'Cultural Background'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1136362', 'cui_str': 'Health Educators'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0233497', 'cui_str': 'Insecurity (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0020942', 'cui_str': 'Immigration'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0362033,A qualitative focus group was conducted with eight staff members (five health educators and three health interviewers) involved in Proyecto Mamá and Estudio Parto.,"[{'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gubrium', 'Affiliation': 'Department of Health Promotion and Policy, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Leckenby', 'Affiliation': 'Department of Health Promotion and Policy, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Megan Ward', 'Initials': 'MW', 'LastName': 'Harvey', 'Affiliation': 'Department of Biostatistics & Epidemiology, School of Public Health & Health Sciences, 401 Arnold House, University of Massachusetts, 715 North Pleasant Street, Amherst, MA, 01003-9304, USA.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Milagros C', 'Initials': 'MC', 'LastName': 'Rosal', 'Affiliation': 'Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chasan-Taber', 'Affiliation': 'Department of Biostatistics & Epidemiology, School of Public Health & Health Sciences, 401 Arnold House, University of Massachusetts, 715 North Pleasant Street, Amherst, MA, 01003-9304, USA. LCT@schoolph.umass.edu.'}]",BMC health services research,['10.1186/s12913-019-4207-x'] 1431,32417634,"Supplemental selenium and coenzyme Q10 reduce glycation along with cardiovascular mortality in an elderly population with low selenium status - A four-year, prospective, randomised, double-blind placebo-controlled trial.","BACKGROUND A low intake of selenium has been shown to increase the risk of cardiovascular mortality, and supplementation of selenium and coenzyme Q10 influences this. The mechanism behind is unclear although effects on inflammation, oxidative stress and microRNA expression have been reported. Fructosamine, a marker of long-term glycaemic control, is also a marker of increased risk of heart disease and death, even in non-diabetics. OBJECTIVE To analyse the impact of selenium and coenzyme Q10 supplementation on the concentration of fructosamine. Also, the relation between pre-intervention serum selenium concentration and the effect on fructosamine of the intervention was studied. METHODS Fructosamine plasma concentration was determined in 219 participants after six and 42 months of intervention with selenium yeast (200 μg/day) and coenzyme Q10 (200 mg/ day) (n = 118 of which 20 had diabetes at inclusion), or placebo (n = 101 of which 18 had diabetes at inclusion). Pre-intervention, the serum selenium levels were 67 μg/L (active treatment group: 66.6 μg/L; placebo group: 67.4 μg/L), corresponding to an estimated intake of 35 μg/day. Changes in concentrations of fructosamine following intervention were assessed by the use of T-tests, repeated measures of variance, and ANCOVA analyses. RESULTS Post-intervention selenium concentrations were 210 μg/L in the active group and 72 μg/L in the placebo group. A lower concentration of fructosamine could be seen as a result of the intervention in the total population (P = 0.001) in both the males (P = 0.04) and in the females (P = 0.01) in the non-diabetic population (P = 0.002), and in both the younger (<76 years) (P = 0.01) and the older (≥76 years) participants (P = 0.03). No difference could be demonstrated in fructosamine concentration in the diabetic patients, but the total sample was small (n = 38). In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level. CONCLUSION A significantly lower concentration of fructosamine was observed in the elderly community-living participants supplemented with selenium and coenzyme Q10 for 42 months compared to those on the placebo. As oxidative mechanisms are involved in the glycation of proteins, less glycoxidation could be a result of the supplementation of selenium and coenzyme Q10, which could have contributed to lower cardiac mortality and less inflammation, as has earlier been reported. This study was registered at Clinicaltrials.gov, and has the identifier NCT01443780.",2020,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level. ","['219 participants after six and 42 months of intervention with selenium yeast (200\u202fμg/day) and', 'elderly population with low selenium status - A four-year', '\u202f101 of which 18 had diabetes at inclusion']","['Fructosamine', 'selenium and coenzyme Q10', 'coenzyme Q10 ', 'selenium and coenzyme Q10 supplementation', 'placebo (n', 'Supplemental selenium and coenzyme Q10 reduce glycation', 'placebo']","['serum selenium levels', 'fructosamine', 'concentration of fructosamine', 'fructosamine concentration']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",219.0,0.328184,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level. ","[{'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Alehagen', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University, SE-581 85 Linköping, Sweden. Electronic address: Urban.Alehagen@liu.se.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aaseth', 'Affiliation': 'Research Department, Innlandet Hospital Trust, N-2381 Brumunddal, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Norwegian Institute of Public Health, P.O. Box 222 Skøyen, N-0213 Oslo, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johansson', 'Affiliation': 'Department of Social and Welfare studies. Department of Medical and Health Sciences, Linköping University, SE-601 74 Norrköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, SE-751 85 Uppsala, Sweden.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126541'] 1432,32418142,Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.,"INTRODUCTION Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients. METHODS In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. The primary efficacy endpoint was a composite of cardiac death, myocardial infarction, and stroke. Safety endpoints included the Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events. Propensity score matching (PSM) was used to compare baseline characteristics between the < 12-month and ≥ 12-month DAPT groups. RESULTS In this cohort of ACS patients (n = 10,016), MMACS patients (n = 2967) were less likely to use DAPT at 12 (31.64% vs. 67.47%, P < 0.0001) and 24 (13.82% vs. 18.71%, P < 0.0001) months and experienced more ischemic events at 12 (4.55% vs. 3.40%, P = 0.006) and 24 (6.88% vs. 5.08%, P = 0.0004) months than those treated with percutaneous coronary intervention (n = 7049). Among MMACS patients, the rate of primary efficacy endpoint occurring within the second year was significantly higher in the < 12-month DAPT group than in the ≥ 12-month group both before (2.88% vs. 1.60%, P = 0.040) and after (3.19% vs. 1.71%, P = 0.045) PSM. After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups. CONCLUSION MMACS patients with insufficient DAPT management experienced relatively more ischemic events. DAPT for at least 1 year may be beneficial to this special population without significantly increasing the bleeding risks. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT01735305.",2020,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups. ","['Medically Managed Acute Coronary Syndrome Patients', 'Chinese Patients with Coronary Artery Disease', 'medically managed acute coronary syndrome (ACS) (MMACS) patients']","['DAPT', 'antiplatelet therapy (DAPT) duration', 'percutaneous coronary intervention', 'MMACS']","['rate of primary efficacy endpoint', 'Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events', 'Propensity score matching (PSM', 'bleeding risks', 'ischemic events', 'all bleeding, BARC 2-5, and BARC 3-5 bleeding', 'efficacy and safety of\u2009≥', 'composite of cardiac death, myocardial infarction, and stroke']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0365972,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups. ","[{'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Miaohan', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China. han1320288258@qq.com.'}]",Advances in therapy,['10.1007/s12325-020-01376-0'] 1433,29569727,Iron isomaltoside is superior to iron sucrose in increasing hemoglobin in gynecological patients with iron deficiency anemia.,,2018,,['gynecological patients with iron deficiency anemia'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]",[],[],,0.041596,,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Roman', 'Affiliation': 'Lakes Research, Miami Lakes, Florida.'}, {'ForeName': 'Gioi N', 'Initials': 'GN', 'LastName': 'Smith-Nguyen', 'Affiliation': 'Grossmont Center for Clinical Research, La Mesa, California.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Achebe', 'Affiliation': ""Division of Hematology, Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical and Non-clinical Research, Pharmacosmos A/S, Holbaek, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Georgetown University School of Medicine, Washington, District of Columbia.'}]",American journal of hematology,['10.1002/ajh.25094'] 1434,32418361,"Baseline demographic, clinical, and cognitive characteristics of the Alzheimer's Prevention Initiative (API) Autosomal-Dominant Alzheimer's Disease Colombia Trial.","INTRODUCTION The API AutosomalDominant AD (ADAD) Colombia Trial is a placebo-controlled clinical trial of crenezumab in 252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1) E280A kindred members, including mutation carriers randomized to active treatment or placebo and non-carriers who receive placebo. METHODS Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity. RESULTS We summarize demographic, clinical, cognitive, and behavioral data from 167 mutation carriers and 75 non-carriers, 30 to 53 years of age. Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores. DISCUSSION Although PSEN1 E280A mutation carriers in the Trial are cognitively unimpaired, they have slightly lower MMSE and memory scores than non-carriers. Their demographic characteristics are representative of the local population.",2020,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores. ","['167 mutation carriers and 75 non-carriers, 30 to 53 years of age', '252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1', 'Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity', 'E280A kindred members, including mutation carriers randomized to active treatment or']","['API AutosomalDominant AD (ADAD', 'placebo and non-carriers who receive placebo', 'crenezumab', 'placebo']",['Mini Mental Status Exam (MMSE) scores'],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0299212', 'cui_str': 'Presenilin 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.37236,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores. ","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Rios-Romenets', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lopera', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Cho', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Mackey', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Langbaum', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Thomas', 'Affiliation': 'University of California, San Diego, California, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Giraldo-Chica', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tobon', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Acosta-Baena', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ospina', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Tirado', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Henao', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Yamile', 'Initials': 'Y', 'LastName': 'Bocanegra', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Dhruman', 'Initials': 'D', 'LastName': 'Goradia', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Thiyyagura', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'VanGilder', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ghisays', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Malek-Ahmadi', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Protas', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yakeel T', 'Initials': 'YT', 'LastName': 'Quiroz', 'Affiliation': 'Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reiman', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12109'] 1435,32424335,Clonidine versus phenobarbital as adjunctive therapy for neonatal abstinence syndrome.,"OBJECTIVE To compare clonidine versus phenobarbital as adjunctive therapy in infants who failed monotherapy with morphine for neonatal abstinence syndrome (NAS). STUDY DESIGN Prospective, randomized, open-label study of infants ≥ 35 weeks' gestation. Infants received clonidine or phenobarbital per protocol. Primary outcome was morphine treatment days. Secondary outcomes were inpatient adjunctive days, length of stay (LOS), triple therapy, safety, and readmission rates. RESULTS A total of 25 infants were treated with clonidine (n = 14) or phenobarbital (n = 11). Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026). The clonidine group also had higher inpatient adjunctive days (mean: 33.8 days [SD = 14.3] vs. 22 days [SD = 12.6], p = 0.042) and LOS (mean: 41.8 days [SD = 10.9] vs. 31 days [SD = 10]; p = 0.018) compared with phenobarbital. CONCLUSIONS Phenobarbital, as adjunctive therapy, led to significantly shorter duration of morphine therapy, inpatient adjunctive days, and length of stay compared with clonidine.",2020,"Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026).","['infants who failed monotherapy with morphine for neonatal abstinence syndrome (NAS', ""infants\u2009≥\u200935 weeks' gestation"", 'neonatal abstinence syndrome', '25 infants']","['clonidine', 'clonidine or phenobarbital', 'clonidine versus phenobarbital', 'phenobarbital', 'Clonidine', 'morphine']","['Mean morphine treatment duration', 'LOS', 'shorter duration of morphine therapy, inpatient adjunctive days, and length of stay', 'higher inpatient adjunctive days', 'inpatient adjunctive days, length of stay (LOS), triple therapy, safety, and readmission rates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",25.0,0.0725641,"Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026).","[{'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Brusseau', 'Affiliation': 'Department of Pharmacy, University of Tennessee Medical Center, Knoxville, TN, USA. cbrussea@utmck.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Burnette', 'Affiliation': 'Department of Neonatology, University of Tennessee Medical Center, Knoxville, TN, USA.'}, {'ForeName': 'R Eric', 'Initials': 'RE', 'LastName': 'Heidel', 'Affiliation': 'Department of Surgery, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0685-2'] 1436,32418547,Consuming decaffeinated coffee with milk and sugar added before a high-glycaemic index meal improves postprandial glycaemic and insulinaemic responses in healthy adults.,"The present study aimed to compare the effects of drinking different types of coffee before a high-glycaemic index (GI) meal on postprandial glucose metabolism and to assess the effects of adding milk and sugar into coffee. In this randomised, crossover, acute feeding study, apparently healthy adults (n 21) consumed the test drink followed by a high-GI meal in each session. Different types of coffee (espresso, instant, boiled and decaffeinated, all with milk and sugar) and plain water were tested in separate sessions, while a subset of the participants (n 10) completed extra sessions using black coffees. Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1) and nitrotyrosine between different test drinks were compared using linear mixed models. Results showed that only preloading decaffeinated coffee with milk and sugar led to significantly lower glucose incremental AUC (iAUC; 14 % lower, P = 0·001) than water. Preloading black coffees led to greater postprandial glucose iAUC than preloading coffees with milk and sugar added (12-35 % smaller, P < 0·05 for all coffee types). Active GLP-1 and nitrotyrosine levels were not significantly different between test drinks. To conclude, preloading decaffeinated coffee with milk and sugar led to a blunted postprandial glycaemic response after a subsequent high-GI meal, while adding milk and sugar into coffee could mitigate the impairment effect of black coffee towards postprandial glucose responses. These findings may partly explain the positive effects of coffee consumption on glucose metabolism.",2020,"Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1), and nitrotyrosine between different test drinks were compared using linear mixed models.","['healthy adults', 'apparently healthy adults (n = 21']","['Consuming decaffeinated coffee with milk and sugar added before a high glycaemic index meal', 'preloading decaffeinated coffee with milk and sugar', 'drinking different types of coffee before a high glycaemic index (GI) meal', 'consumed the test drink followed by a high GI meal', 'coffee (espresso, instant, boil, and decaffeinated, all with milk and sugar) and plain water']","['postprandial glycaemic response', 'postprandial glucose metabolism', 'glucose incremental area-under-curves', 'postprandial glycaemic and insulinaemic responses', 'Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1), and nitrotyrosine between different test drinks', 'postprandial glucose responses', 'postprandial glucose iAUCs', 'glucose metabolism', 'Active GLP-1 and nitrotyrosine levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0452434', 'cui_str': 'Coffee with milk and sugar'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0242301', 'cui_str': 'Furuncle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0047645', 'cui_str': '3-nitrotyrosine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",21.0,0.0270596,"Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1), and nitrotyrosine between different test drinks were compared using linear mixed models.","[{'ForeName': 'Tommy H T', 'Initials': 'THT', 'LastName': 'Wong', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Pokfulam, Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Jennifer M F', 'Initials': 'JMF', 'LastName': 'Wan', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Pokfulam, Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Iris M Y', 'Initials': 'IMY', 'LastName': 'Tse', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Pokfulam, Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Sit', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Pokfulam, Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Jimmy C Y', 'Initials': 'JCY', 'LastName': 'Louie', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Pokfulam, Hong Kong, Hong Kong Special Administrative Region.'}]",The British journal of nutrition,['10.1017/S0007114520001750'] 1437,25743855,"Aprepitant versus metoclopramide, both combined with dexamethasone, for the prevention of cisplatin-induced delayed emesis: a randomized, double-blind study.","BACKGROUND A combination of aprepitant, a 5-HT3 receptor antagonist (r.a.), and dexamethasone is recommended for the prophylaxis of cisplatin-induced nausea and vomiting in the acute phase, and aprepitant + dexamethasone (A + D) in the delayed phase. The aim of this study was to verify if A + D is superior to metoclopramide plus dexamethasone (M + D) in preventing delayed emesis in cancer patients receiving the same prophylaxis for acute emesis. PATIENTS AND METHODS A randomized double-blind study comparing A + D versus M + D was completed in previously untreated cancer patients. Before chemotherapy, all patients were treated with intravenous palonosetron 0.25 mg and dexamethasone 12 mg, and oral aprepitant 125 mg. On day 2-4, patients randomly received oral dexamethasone 8 mg plus aprepitant 80 mg once daily (days 2-3) or metoclopramide 20 mg four times daily plus dexamethasone 8 mg bid. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) in day 2-5 after chemotherapy. RESULTS Due to difficulty in the accrual of patients, 303 of the 480 planned patients were enrolled, 284 were fully evaluable, 147 receiving A + D, 137 M + D. Day 1 results were similar in both arms. On day 2-5, complete response rate was not significantly different (80.3% with A + D versus 82.5% with M + D, P < 0.38, respectively), and all secondary endpoints were also similar (complete protection, total control, no vomiting, no nausea, and score of Functional Living Index-Emesis; P < 0.24). Adverse events incidence was not significantly different between the two treatments. CONCLUSIONS In cancer patients submitted to cisplatin-based chemotherapy, receiving the same antiemetic prophylaxis for acute emesis, A + D is not superior to M + D in preventing delayed emesis, and both treatments present similar toxicity. CLINICALTRIALSGOV NUMBER NCT00869310.",2015,"Adverse events incidence was not significantly different between the two treatments. ","['cancer patients receiving the same prophylaxis for acute emesis', 'previously untreated cancer patients', ' 303 of the 480 planned patients were enrolled, 284 were fully evaluable, 147 receiving A + D, 137 M + D. Day 1 results were similar in both arms']","['metoclopramide', 'cisplatin', 'dexamethasone', 'metoclopramide plus dexamethasone (M + D', ' D versus M + D', 'oral dexamethasone', 'cisplatin-based chemotherapy', 'intravenous palonosetron 0.25 mg and dexamethasone', 'metoclopramide 20 mg four times daily plus dexamethasone']","['Adverse events incidence', 'rate of complete response (no vomiting, no rescue treatment', 'total control, no vomiting, no nausea, and score of Functional Living Index-Emesis', 'complete response rate', 'delayed emesis']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4691686', 'cui_str': 'palonosetron 0.25 MG'}, {'cui': 'C0585291', 'cui_str': 'Four times daily (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",,0.273069,"Adverse events incidence was not significantly different between the two treatments. ","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Roila', 'Affiliation': ""Medical Oncology Division, 'S. Maria' Hospital, Terni. Electronic address: roila.fausto@libero.it.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ruggeri', 'Affiliation': 'Clinical Governance, ASUR Marche, Ascoli Piceno.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ballatori', 'Affiliation': ""Internal Medicine and Public Health, University of L'Aquila, Spinetoli.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fatigoni', 'Affiliation': ""Medical Oncology Division, 'S. Maria' Hospital, Terni.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Caserta', 'Affiliation': ""Medical Oncology Division, 'S. Maria' Hospital, Terni.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Medical Oncology, National Cancer Institute, Milano.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirabile', 'Affiliation': 'Medical Oncology, National Cancer Institute, Milano.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Ionta', 'Affiliation': 'Medical Oncology II, University Hospital, Cagliari.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massidda', 'Affiliation': 'Medical Oncology II, University Hospital, Cagliari.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Medical Oncology, Piacenza Hospital, Piacenza.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Palladino', 'Affiliation': 'Medical Oncology, Piacenza Hospital, Piacenza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tocci', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera di Legnano, Legnano.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fava', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera di Legnano, Legnano.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Colantonio', 'Affiliation': 'Medical Oncology, Santa Croce e Carle Hospital, Cuneo.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Angelelli', 'Affiliation': 'Medical Oncology, ASUR Marche, Ascoli Piceno.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ciuffreda', 'Affiliation': 'Medical Oncology, Molinette Hospital, Torino.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fasola', 'Affiliation': 'Medical Oncology, University Hospital S. Maria della Misericordia, Udine.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zerilli', 'Affiliation': 'Medical Oncology, S. Antonio Abate Hospital, Trapani, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv132'] 1438,31092125,Model Simulations Challenge Reductionist Research Approaches to Studying Chronic Low Back Pain.,"BACKGROUND Traditionally, low back pain (LBP) is studied using a reductionist approach, in which the factors contributing to the clinical presentation of LBP are studied in isolation to identify the primary pathology or condition linked to LBP. We argue that reductionism may not be suitable for studying LBP, considering the complex, multifactorial nature of this condition. OBJECTIVES To quantify the likelihood of successfully subclassifying patients with LBP and effectively targeting treatment based on a single dominant factor contributing to LBP. METHODS Both analytical and numerical simulations (Monte Carlo) of 1 million patients with LBP were performed. Several factors contributing to LBP were randomly assigned to each individual. The following outcome measures were computed, as a function of the number of factors: the percentage of individuals who could be subclassified by identifying a single factor exceeding a certain threshold, and the average reduction in LBP when treatment eliminates the largest contributing factor versus a multimodal treatment that eliminates a number of the randomly selected factors. RESULTS With an increasing number of factors, the probability of subclassifying an individual to a subgroup based on a single factor tends toward zero. A multimodal treatment arbitrarily addressing any 2 or more factors was more effective than diagnosing and treating a single factor that maximally contributed to LBP. CONCLUSION Results suggest that reductionism is not appropriate for subclassifying patients with LBP or for targeting treatment. The use of reductionist approaches may explain some of the challenges when creating LBP classification systems and designing effective treatment interventions. J Orthop Sports Phys Ther 2019;49(6):477-481. Epub 15 May 2019. doi:10.2519/jospt.2019.8791 .",2019,"RESULTS With an increasing number of factors",['1 million patients with LBP'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],0.0,0.0243796,"RESULTS With an increasing number of factors","[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Cholewicki', 'Affiliation': ''}, {'ForeName': 'Pramod K', 'Initials': 'PK', 'LastName': 'Pathak', 'Affiliation': ''}, {'ForeName': 'N Peter', 'Initials': 'NP', 'LastName': 'Reeves', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Popovich', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8791'] 1439,32420683,"Discovery of Intake Biomarkers of Lentils, Chickpeas, and White Beans by Untargeted LC-MS Metabolomics in Serum and Urine.","SCOPE To identify reliable biomarkers of food intake (BFIs) of pulses. METHODS AND RESULTS A randomized crossover postprandial intervention study is conducted on 11 volunteers who consumed lentils, chickpeas, and white beans. Urine and serum samples are collected at distinct postprandial time points up to 48 h, and analyzed by LC-HR-MS untargeted metabolomics. Hypaphorine, trigonelline, several small peptides, and polyphenol-derived metabolites prove to be the most discriminating urinary metabolites. Two arginine-related compounds, dopamine sulfate and epicatechin metabolites, with their microbial derivatives, are identified only after intake of lentils, whereas protocatechuic acid is identified only after consumption of chickpeas. Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, are found after white bean consumption. Most of the metabolites identified in the postprandial study are replicated as discriminants in 24 h urine samples, demonstrating that in this case the use of a single, noninvasive sample is suitable for revealing the consumption of pulses. CONCLUSIONS The results of the present untargeted metabolomics work reveals a broad list of metabolites that are candidates for use as biomarkers of pulse intake. Further studies are needed to validate these BFIs and to find the best combinations of them to boost their specificity.",2020,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","['11 volunteers who consumed lentils, chickpeas and white beans']","['Hypaphorine, trigonelline', 'dopamine sulfate and epicatechin metabolites']",['Urine and serum samples'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0446305', 'cui_str': 'White bean'}]","[{'cui': 'C0064754', 'cui_str': 'lenticin'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}]",11.0,0.0132396,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Garcia-Aloy', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Marynka', 'Initials': 'M', 'LastName': 'Ulaszewska', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Center for Omics Sciences, Proteomics and Metabolomics Facility - ProMeFa, Milan, 20132, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Franceschi', 'Affiliation': ""Computational Biology Unit, Research and Innovation Center, Fondazione Edmund Mach, San Michele all'Adige, 38010, Italy.""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Estruel-Amades', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Christoph H', 'Initials': 'CH', 'LastName': 'Weinert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Federal Research Institute of Nutrition and Food, Karlsruhe, 76131, Germany.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Tor-Roca', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Urpi-Sarda', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Center, Fondazione Edmund Mach (FEM), San Michele all'Adige, 38010, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andres-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901137'] 1440,25833335,"Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance.","Telegenetics-genetic counseling via live videoconferencing-can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost. We report cost, patient satisfaction and CGC attendance from a randomized trial comparing telegenetics with in-person CGC among individuals referred to CGC in four rural oncology clinics. Participants (n = 162) were randomized to receive CGC at their local oncology clinic in-person or via telegenetics. Cost analyses included telegenetics system; mileage; and personnel costs for genetic counselor, IT specialist, and clinic personnel. CGC attendance was tracked via study database. Patient satisfaction was assessed 1 week post-CGC via telephone survey using validated scales. Total costs were $106 per telegenetics patient and $244 per in-person patient. Patient satisfaction did not differ by group on either satisfaction scale. In-person patients were significantly more likely to attend CGC than telegenetics patients (89 vs. 79 %, p = 0.03), with bivariate analyses showing an association between lesser computer comfort and lower attendance rate (Chi-square = 5.49, p = 0.02). Our randomized trial of telegenetics vs. in-person counseling found that telegenetics cost less than in-person counseling, with high satisfaction among those who attended. This study provides support for future randomized trials comparing multiple service delivery models on longer-term psychosocial and behavioral outcomes.",2015,"Telegenetics-genetic counseling via live videoconferencing-can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost.","['individuals referred to CGC in four rural oncology clinics', 'Participants (n\u2009=\u2009162']","['telegenetics vs. in-person counseling', 'Telegenetics-genetic counseling via live videoconferencing', 'CGC at their local oncology clinic in-person or via telegenetics']","['computer comfort and lower attendance rate', 'Patient satisfaction', 'satisfaction scale', 'CGC attendance', 'Total costs', 'personnel costs for genetic counselor, IT specialist, and clinic personnel']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0017382', 'cui_str': 'Genetic Counseling'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",4.0,0.207459,"Telegenetics-genetic counseling via live videoconferencing-can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost.","[{'ForeName': 'Adam H', 'Initials': 'AH', 'LastName': 'Buchanan', 'Affiliation': 'Genomic Medicine Institute, Geisinger Health System, M.C. 26-20, 100 N. Academy Ave., Danville, PA, 17822, USA. ahbuchanan@geisinger.edu.'}, {'ForeName': 'Santanu K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Department of Clinical Sciences and Harold C Simmons Cancer Center, University of Texas - Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Hollowell', 'Affiliation': 'Department of Biology, North Carolina Central University, Durham, NC, USA.'}, {'ForeName': 'Henry F', 'Initials': 'HF', 'LastName': 'Beresford', 'Affiliation': 'School of Nursing, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Freeland', 'Affiliation': 'Office of Information Technology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boling', 'Affiliation': 'School of Nursing, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'P Kelly', 'Initials': 'PK', 'LastName': 'Marcom', 'Affiliation': 'Genomic Medicine Institute, Geisinger Health System, M.C. 26-20, 100 N. Academy Ave., Danville, PA, 17822, USA.'}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Adams', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}]",Journal of genetic counseling,['10.1007/s10897-015-9836-6'] 1441,31775515,Self-efficacy and response-efficacy: critical components of sexual and reproductive health interventions targeting condom use intention among American Indian adolescents.,"The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age). This paper seeks to identify critical program components of the RCL intervention for replication of impacts on condom use intention (CUI) when scaling to additional communities. RCL was tested among AI adolescents through a cluster randomized controlled trial (N = 267) embedded in an 8-day basketball camp. Data were collected at baseline, immediately post-camp, at 6 and 12 months post-camp. Previously established predictors of CUI that were statistically significantly impacted by RCL at the post-camp time point were tested as mediators of RCL impact on CUI. Condom use self-efficacy and response efficacy fully mediated the effect of RCL on CUI. The indirect path through condom use self-efficacy had the greatest effect on CUI, explaining 79% of the direct effect. When stratified by gender, there was only evidence of mediation among girls. Results indicate condom use self-efficacy and response efficacy are critical components of the RCL intervention for AI girls, and sexual/reproductive health programs should include practical skills training to improve these constructs to maximize intervention impact on CUI.",2020,"The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age).","['American Indian (AI) adolescents (13-19 years of age', 'American Indian adolescents']","['RCL intervention', 'RCL', 'sexual and reproductive health interventions']",[],"[{'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0242667', 'cui_str': 'Reproductive Health'}]",[],,0.0257323,"The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age).","[{'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Rosenstock', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Angelita', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Whiteriver, USA.'}, {'ForeName': 'Novalene', 'Initials': 'N', 'LastName': 'Goklish', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Whiteriver, USA.'}, {'ForeName': 'Francene', 'Initials': 'F', 'LastName': 'Larzelere', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Whiteriver, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA.'}]",AIDS care,['10.1080/09540121.2019.1695726'] 1442,32425222,Repurposing chlorpromazine to treat COVID-19: The reCoVery study.,"OBJECTIVES The ongoing COVID-19 pandemic has caused approximately 2,350,000 infections worldwide and killed more than 160,000 individuals. In Sainte-Anne Hospital (GHU PARIS Psychiatrie & Neuroscience, Paris, France) we have observed a lower incidence of symptomatic forms of COVID-19 among patients than among our clinical staff. This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties. Chlorpromazine (CPZ), a phenothiazine derivative, is also known for its antiviral activity via the inhibition of clathrin-mediated endocytosis. Recentin vitro studies have reported that CPZ exhibits anti-MERS-CoV and anti-SARS-CoV-1 activity. METHODS In this context, the ReCoVery study aims to repurpose CPZ, a molecule with an excellent tolerance profile and a very high biodistribution in the saliva, lungs and brain. We hypothesize that CPZ could reduce the unfavorable course of COVID-19 infection among patients requiring respiratory support without the need for ICU care, and that it could also reduce the contagiousness of SARS-CoV-2. For this purpose, we plan a pilot, multicenter, randomized, single blind, controlled, phase III therapeutic trial (standard treatment vs. CPZ+standard treatment). CONCLUSION This repurposing of CPZ for its anti-SARS-CoV-2 activity could offer an alternative, rapid strategy to alleviate infection severity. This repurposing strategy also avoids numerous developmental and experimental steps, and could save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easily managed side effects.",2020,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.",[],"['Chlorpromazine (CPZ', 'chlorpromazine', 'phenothiazine derivative', 'CPZ', 'CPZ + standard treatment']",[],[],"[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0585347,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for Medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research University, Univ Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 Evolutionary Genomics of RNA Viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France; GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.05.006'] 1443,31182400,Antimicrobial prophylaxis for urinary tract infections: implications for adherence assessment.,"BACKGROUND Continuous antimicrobial prophylaxis (prophylaxis) is associated with a reduction in recurrent urinary tract infections in children with vesicoureteral reflux. However, adherence to daily medications has been shown to be poor. OBJECTIVE To determine patient/caregiver factors associated with non-adherence and to determine whether adherence alters the effect of prophylaxis on recurrent UTIs and renal scarring. STUDY DESIGN We conducted a secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux trial. We stratified adherence scores into quartiles to assess trends within the data. We assessed predictors of non-adherence using ordinal logistic regression. We then examined the efficacy of prophylaxis stratified by adherence quartiles. RESULTS Six hundred patients were included in the analysis. The quartiles of adherence were as follows: 1st quartile-0-70% adherence; 2nd quartile-71-91% adherence; 3rd quartile-92-96% adherence; and 4th quartile->96% adherence. Neither demographic factors nor disease severity was associated with non-adherence. In the subanalysis of patients who were toilet trained at baseline, increasing bladder and bowel dysfunction (BBD) symptom score was associated with non-adherence (adjusted odds ratio, aOR = 1.1, 95% confidence interval [CI] 1.0-1.2). Patients least adherent were 2.5 times more likely (95%CI 1.1-5.6) to have a recurrent UTI compared with patients most adherent. After controlling for treatment arm, age, sex, degree of reflux, BBD, and number of UTIs, patients least adherent (taking the study medication less than <70% of the time) were at highest risk for renal scarring (aOR = 24.2, 95%CI 3.0-197). In contrast, among the most adherent quartile, the probability of renal scarring was highest in those assigned prophylaxis (16.2% compared with 1.7% in those most adherent to placebo). CONCLUSIONS Adherence is distinctly related to clinical outcomes in children with VUR. Non-adherence is common and represents a distinct clinical entity that is associated with renal scarring. Adherence should be assessed in prophylaxis management algorithms.",2019,Patients least adherent were 2.5 times more likely (95%CI 1.1-5.6) to have a recurrent UTI compared with patients most adherent.,"['children with vesicoureteral reflux', 'children with VUR', 'Six hundred patients were included in the analysis', 'Children with Vesicoureteral Reflux trial', 'urinary tract infections']","['antimicrobial prophylaxis (prophylaxis', 'Antimicrobial prophylaxis']","['bladder and bowel dysfunction (BBD) symptom score', 'probability of renal scarring', 'renal scarring']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteral Reflux'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]","[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C2004461', 'cui_str': 'Bowel dysfunction (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1700247', 'cui_str': 'Renal scarring'}]",600.0,0.0984212,Patients least adherent were 2.5 times more likely (95%CI 1.1-5.6) to have a recurrent UTI compared with patients most adherent.,"[{'ForeName': 'T W', 'Initials': 'TW', 'LastName': 'Gaither', 'Affiliation': 'Department of Urology, University of California, San Francisco, USA.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Copp', 'Affiliation': 'Department of Urology, University of California, San Francisco, USA. Electronic address: Hillary.Copp@ucsf.edu.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.04.019'] 1444,25613105,Gender-based Outcomes and Acceptability of a Computer-assisted Psychosocial Intervention for Substance Use Disorders.,"BACKGROUND Digital technologies show promise for increasing treatment accessibility and improving quality of care, but little is known about gender differences. This secondary analysis uses data from a multi-site effectiveness trial of a computer-assisted behavioral intervention, conducted within NIDA's National Drug Abuse Clinical Trials Network, to explore gender differences in intervention acceptability and treatment outcomes. METHODS Men (n=314) and women (n=192) were randomly assigned to 12-weeks of treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week. TES is composed of 62 Web-delivered, multimedia modules, covering skills for achieving and maintaining abstinence plus prize-based incentives contingent on abstinence and treatment adherence. Outcomes were: (1) abstinence from drugs and heavy drinking in the last 4weeks of treatment, (2) retention, (3) social functioning, and (4) drug and alcohol craving. Acceptability was the mean score across five indicators (i.e., interesting, useful, novel, easy to understand, and satisfaction). RESULTS Gender did not moderate the effect of treatment on any outcome. Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12. Acceptability was positively associated with abstinence, but only among women (p=.01). CONCLUSIONS Findings suggest that men and women derive similar benefits from participating in a computer-assisted intervention, a promising outcome as technology-based treatments expand. Acceptability was associated with abstinence outcomes among women. Future research should explore characteristics of women who report less satisfaction with this modality of treatment and ways to improve overall acceptability.",2015,"Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12.",['Men (n=314) and women (n=192'],"['TES', 'Computer-assisted Psychosocial Intervention', 'treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week', 'computer-assisted behavioral intervention']","['acceptability scores', 'Acceptability', 'abstinence from drugs and heavy drinking in the last 4weeks of treatment, (2) retention, (3) social functioning, and (4) drug and alcohol craving']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}]",,0.163251,"Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12.","[{'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': ""Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA; Mount Sinai St. Luke's Hospital Department of Psychiatry and Behavioral Health, 1111 Amsterdam Ave, New York, NY 10025, USA. Electronic address: anc2002@columbia.edu.""}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Mailman School of Public Health Department of Biostatistics, 722 West 168th Street, 6th Floor, New York, NY 10032, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hatch-Maillette', 'Affiliation': 'University of Washington Department of Psychiatry and Behavioral Sciences and Alcohol and Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Box 354805, Seattle, WA 98105, USA.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Columbia University Medical Center, Department of Psychiatry, 630 West 168th Street, New York, NY 10032, USA.'}, {'ForeName': 'Genie L', 'Initials': 'GL', 'LastName': 'Bailey', 'Affiliation': 'Stanley Street Treatment and Research Center and Brown University Alpert Medical School, 386 Stanley St, Fall River, MA 02720, USA.'}, {'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Sugarman', 'Affiliation': 'Harvard Medical School, Department of Psychiatry and McLean Hospital Division of Alcohol and Drug Abuse, 115 Mill Street, Belmont, MA 02478, USA.'}, {'ForeName': 'Gloria M', 'Initials': 'GM', 'LastName': 'Miele', 'Affiliation': 'Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Rieckmann', 'Affiliation': 'Oregon Health and Science University School of Medicine, 3181S.W. Sam Jackson Park Rd., Portland, OR 97239, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Shores-Wilson', 'Affiliation': 'University of Texas Southwestern Medical Center Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75390, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Turrigiano', 'Affiliation': 'Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School, Department of Psychiatry and McLean Hospital Division of Alcohol and Drug Abuse, 115 Mill Street, Belmont, MA 02478, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2014.12.006'] 1445,32425361,"Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.","BACKGROUND Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza. PURPOSE To determine the safety and efficacy of LH capsule in patients with Covid-19. METHODS We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery. RESULTS We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported. CONCLUSION In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.",2020,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P <0.001) and clinical cure (78.9% vs. 66.2%, P= 0.017) was also higher in treatment group.","['patients with Covid-19', '284 patients (142 each in treatment and control group) in the full-analysis set', 'Patients with Coronavirus disease 2019']","['LH capsule', 'Lianhuaqingwen Capsules, a repurposed Chinese Herb', 'usual treatment alone or in combination with LH capsules']","['Efficacy and Safety', 'rate of improvement in chest computed tomographic manifestations', 'coughing', 'Time to recovery of fever', 'fatigue', 'rate of symptom (fever, fatigue, coughing) recovery', 'rate of conversion to severe cases or viral assay findings', 'clinical cure', 'safety and efficacy', 'serious adverse events', 'median time to symptom recovery', 'recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",284.0,0.213016,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P <0.001) and clinical cure (78.9% vs. 66.2%, P= 0.017) was also higher in treatment group.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang province, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'The First Teaching Hospital of Tianjin University of traditional Chinese medicine.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of traditional Chinese medicine, Beijing, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Youan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Shanghai University of traditional Chinese medicine, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Fuyang Second People's Hospital, Fuyang, China.""}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, Hubei province, China.'}, {'ForeName': 'Chaomin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Jia', 'Affiliation': 'Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province 050035 PR China. Electronic address: jzhjiazhenhua@163.com.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China. Electronic address: nanshan@vip.163.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153242'] 1446,32425482,Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes.,"Objectives We aim to evaluate our policy of index admission management of gall bladder empyema and the effect of the timing of surgery on the outcomes. Methods We analyzed a series of 5400 laparoscopic cholecystectomies. Data were collected prospectively over 26 y. Patients were divided into two groups: group 1, intervention within 72 h, and group 2, intervention after 72 h of admission. We had a policy of intention to treat during the index admission, but delays sometimes occurred because of late referral, a need to optimize patients, availability of theater time, or the biliary surgeon being on leave. The groups were then compared with regard to the duration of surgery, the difficulty grading, complications, hospital stay, and conversion rate. Results A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2). There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate. The difference in total hospital stay was, however, statistically significant. Conclusion Surgical management of empyema should be offered as soon as possible after admission as with any acute cholecystitis. Surgery carried out after 72 h of admission is only associated with longer hospital stay but no statistically significant differences in other outcome parameters. In the presence of specialist expertise, fitness for surgery should be the determining factor of whether or not to offer surgery to these patients, regardless of the interval since their admission.",2020,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","['5400 laparoscopic cholecystectomies', 'Gall Bladder Empyema', 'A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2']",[],"['difficulty grading, complications, hospital stay, and conversion rate', 'longer hospital stay', 'operation time, conversion rate, and complications rate', 'total hospital stay']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0014012', 'cui_str': 'Empyema of gallbladder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]",[],"[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",372.0,0.051755,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","[{'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'El Zanati', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ahmad H M', 'Initials': 'AHM', 'LastName': 'Nassar', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Zino', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Katbeh', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Hwei Jene', 'Initials': 'HJ', 'LastName': 'Ng', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abdellatif', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00015'] 1447,31318033,"Moderate Postmeal Walking Has No Beneficial Effects Over Resting on Postprandial Lipemia, Glycemia, Insulinemia, and Selected Oxidative and Inflammatory Parameters in Older Adults with a Cardiovascular Disease Risk Phenotype: A Randomized Crossover Trial.","BACKGROUND Research suggests that postprandial events, as risk factors for cardiovascular diseases (CVDs), are influenced by meal composition and exercise. OBJECTIVES We investigated the effect of walking versus rest on postprandial metabolic, inflammatory, and oxidative events following the consumption of test meals reflecting 2 different dietary patterns in older adults with an increased CVD risk. METHODS A randomized crossover trial was conducted in 26 men and women (aged 70 ± 5 y; BMI 30.3 ± 2.3 kg/m2). Each adult participated in 4 treatments combining 1 of 2 iso-energetic (4300 kJ) meals [Western diet high-fat meal (WD): total fat, 59.4 g; saturated fatty acids, 32.0 g, dietary fiber, 4.2 g; or Mediterranean-type diet meal (MD): total fat, 40.1 g; saturated fatty acids, 5.1 g; dietary fiber, 14.5 g] with 30 min walking (4.6 ± 0.1 km/h) or rest. Primary (serum triglycerides) and secondary [serum nonesterified fatty acids (NEFAs); parameters of glucose metabolism, inflammation, endothelial activation, oxidation; blood pressure/heart rate] outcomes were measured at fasting and 1.5, 3.0, and 4.5 h postprandially. Data were analyzed by linear mixed models. RESULTS Triglycerides were higher after the WD than after the MD [AUC in mmol/L × min: Western diet high-fat meal plus postprandial walking (WD-W), 218 ± 15.2; Western diet high-fat meal plus postprandial resting (WD-R), 207 ± 12.6; Mediterranean-type diet meal plus postprandial walking (MD-W), 139 ± 9.83; Mediterranean-type diet meal plus postprandial resting (MD-R), 149 ± 8.15; P  < 0.001]. No meal or activity effect was observed for NEFAs based on AUC data (WD-W, -43.5 ± 7.08; WD-R, -49.2 ± 6.94; MD-W, -48.0 ± 11.6; MD-R, -67.6 ± 7.58). Plasma glucose was higher after the MD than after the WD (WD-W, 222 ± 34.9; WD-R, 177 ± 32.8; MD-W, 314 ± 44.4; MD-R, 275 ± 57.8; P  < 0.001), as was serum insulin (AUC in nmol/L × min: WD-W, 82.0 ± 10.3; WD-R, 88.6 ± 12.8; MD-W, 129 ± 14.7; MD-R, 138 ± 20.5; P < 0.001). Plasma IL-6 was higher after walking than after resting (AUC in pg/mL × min: WD-W, 72.0 ± 34.0; WD-R, 14.3 ± 38.8; MD-W, 70.8 ± 39.4; MD-R, 5.60 ± 26.0; P < 0.05). Plasma vitamin C was higher after the MD than after the WD (P < 0.001) and after walking than after resting (P < 0.05; AUC in mg/L × min: WD-W, -305 ± 59.6; WD-R, -396 ± 84.0; MD-W, 113 ± 56.4; MD-R, -44.5 ± 48.1). We observed no meal or activity effects on parameters of oxidation and endothelial adhesion molecules. Our data revealed no significant meal × activity effects on all outcomes. CONCLUSIONS In older adults with an increased CVD risk, the MD was associated with superior effects on several postprandial parameters (e.g., triglycerides), in comparison to the WD. Data revealed no relevant differences regarding the effects of postmeal walking and resting. None of the 4 treatments can be rated as superior regarding their acute effects on the shown postprandial metabolic, oxidative, and inflammatory parameters. The trial was registered at German Clinical Trials Register (DRKS; http://www.germanctr.de and http://www.drks.de) under identifier DRKS00012409.",2019,Plasma vitamin C was higher after the MD than after the WD (P ,"['older adults with an increased CVD risk', '26 men and women (aged 70\xa0±\xa05', 'Older Adults with a Cardiovascular Disease Risk Phenotype']","['Western diet high-fat meal plus postprandial walking (WD-W), 218\xa0±\xa015.2; Western diet high-fat meal plus postprandial resting (WD-R), 207\xa0±\xa012.6; Mediterranean-type diet meal plus postprandial walking (MD-W), 139\xa0±\xa09.83; Mediterranean-type diet meal plus postprandial resting (MD-R), 149\xa0±\xa08.15', '2 iso-energetic (4300 kJ) meals [Western diet high-fat meal (WD): total fat, 59.4 g; saturated fatty acids, 32.0 g, dietary fiber, 4.2 g; or Mediterranean-type diet meal (MD): total fat, 40.1 g; saturated fatty acids, 5.1 g; dietary fiber, 14.5 g] with 30 min walking (4.6\xa0±\xa00.1 km/h) or rest']","['Postprandial Lipemia, Glycemia, Insulinemia, and Selected Oxidative and Inflammatory Parameters', 'Primary (serum triglycerides) and secondary [serum nonesterified fatty acids (NEFAs); parameters of glucose metabolism, inflammation, endothelial activation, oxidation', 'postprandial metabolic, oxidative, and inflammatory parameters', 'serum insulin (AUC', 'Plasma IL-6', 'Triglycerides', 'No meal or activity effect', 'postprandial metabolic, inflammatory, and oxidative events', 'Plasma glucose', 'blood pressure/heart rate] outcomes', 'Plasma vitamin C', 'oxidation and endothelial adhesion molecules']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C3849996', 'cui_str': 'Western Dietary Pattern'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439494', 'cui_str': 'km/h'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1706412', 'cui_str': 'Lipemia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",,0.0643944,Plasma vitamin C was higher after the MD than after the WD (P ,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Diekmann', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Huber', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Preuß', 'Affiliation': 'Human Resources Development and Career, Healthy Campus Bonn, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preuß', 'Affiliation': 'University Sports, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Central Laboratory, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Informatics and Epidemiology, Institute of Medical Biometry, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stehle', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Egert', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}]",The Journal of nutrition,['10.1093/jn/nxz148'] 1448,31399438,Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial.,"OBJECTIVE To explore gallbladder- and biliary tract-related events reported for the liraglutide and placebo groups in the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial. RESEARCH DESIGN AND METHODS LEADER was an international, randomized, double-blind, controlled cardiovascular (CV) outcomes trial. Participants with type 2 diabetes at high risk for CV events ( n = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily; n = 4,668) or placebo ( n = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years). Acute gallstone disease was a medical event of special interest. This post hoc analysis categorized captured events of acute gallbladder or biliary disease into four groups: uncomplicated gallbladder stones, complicated gallbladder stones, cholecystitis, and biliary obstruction. Time to first event by treatment group was analyzed using Cox regression. RESULTS There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n = 141 of 4,668 vs. n = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09; P < 0.001). Similar trends were observed for each of the four categories of gallbladder- or biliary tract-related events. Cholecystectomy was performed more frequently in liraglutide-treated patients (HR 1.56; 95% CI 1.10, 2.20; P = 0.013) but for similar proportions of the patients who experienced gallbladder- or biliary tract-related events (57% with liraglutide vs. 59% with placebo). CONCLUSIONS Although LEADER was not specifically designed to assess acute gallbladder or biliary disease, the trial showed an increased risk of gallbladder- or biliary tract-related events with liraglutide versus placebo, which appeared to be consistent across four categories of these events. Further studies should investigate the relevant mechanisms.",2019,"There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n = 141 of 4,668 vs. n = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09; P < 0.001).","['Participants with type 2 diabetes at high risk for CV events ( n = 9,340', 'Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Liraglutide', 'liraglutide', 'liraglutide and placebo', 'placebo', 'Placebo', 'liraglutide versus placebo']","['gallbladder- or biliary tract-related events', 'risk of acute gallbladder or biliary disease', 'gallbladder stones, complicated gallbladder stones, cholecystitis, and biliary obstruction', 'Acute Gallbladder or Biliary Disease']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0005423', 'cui_str': 'Biliary System'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}, {'cui': 'C0008325', 'cui_str': 'Gallbladder Inflammation'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",4672.0,0.459866,"There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n = 141 of 4,668 vs. n = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09; P < 0.001).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany michael.nauck@rub.de.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Muus Ghorbani', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Eskil', 'Initials': 'E', 'LastName': 'Kreiner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0415'] 1449,25084694,Depressive Symptoms and Associated Clinical Characteristics in Outpatients Seeking Community-Based Treatment for Alcohol and Drug Problems.,"BACKGROUND Comorbid psychiatric and substance use disorders are common and associated with poorer treatment engagement, retention, and outcomes. This study examines the presence of depressive symptoms and the demographic and clinical correlates in a diverse sample of substance abuse treatment seekers to better characterize patients with co-occurring depressive symptoms and substance use disorders and understand potential treatment needs. METHODS Baseline data from a randomized clinical effectiveness trial of a computer-assisted, Web-delivered psychosocial intervention were analyzed. Participants (N = 507) were recruited from 10 geographically diverse outpatient drug treatment programs. Assessments included the self-report Patient Health Questionnaire, and measures of coping strategies, social functioning, physical health status, and substance use. RESULTS One fifth (21%; n = 106) of the sample screened positive for depression; those screening positive for depression were significantly more likely to screen positive for anxiety (66.9%) and posttraumatic stress disorder (PTSD; 42.9%). After controlling for anxiety and PTSD symptoms, presence of depressive symptoms remained significantly associated with fewer coping strategies (P = .001), greater impairment in social adjustment (P < .001), and poorer health status (P < .001), but not to days of drug use in the last 90 days (P = .14). CONCLUSIONS Depression is a clinically significant problem among substance abusers, and, in this study, patients who screened positive for depression were more likely to have co-occurring symptoms of anxiety and PTSD. Additionally, the presence of depressive symptoms was associated with fewer coping strategies and poorer social adjustment. Coping skills are a significant predictor of addiction outcomes, and it may be especially important to screen for and enhance coping among depressed patients. Evidence-based interventions that target coping skills and global functioning among substance abusers with depressive symptoms may be important adjuncts to usual treatment.",2015,"After controlling for anxiety and PTSD symptoms, presence of depressive symptoms remained significantly associated with fewer coping strategies (P = .001), greater impairment in social adjustment (P < .001), and poorer health status (P < .001), but not to days of drug use in the last 90 days (P = .14). ","['Participants (N = 507) were recruited from 10 geographically diverse outpatient drug treatment programs', 'patients with co-occurring depressive symptoms and substance use disorders', 'substance abusers with depressive symptoms', 'Outpatients Seeking Community-Based Treatment for Alcohol and Drug Problems']","['computer-assisted, Web-delivered psychosocial intervention']","['Depressive Symptoms', 'coping strategies and poorer social adjustment', 'depressive symptoms', 'self-report Patient Health Questionnaire, and measures of coping strategies, social functioning, physical health status, and substance use', 'screen positive for anxiety', 'poorer health status', 'greater impairment in social adjustment', 'anxiety and PTSD symptoms, presence of depressive symptoms', 'posttraumatic stress disorder']","[{'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0338666', 'cui_str': 'Drug Users'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0037395', 'cui_str': 'Social Adjustment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",507.0,0.0597959,"After controlling for anxiety and PTSD symptoms, presence of depressive symptoms remained significantly associated with fewer coping strategies (P = .001), greater impairment in social adjustment (P < .001), and poorer health status (P < .001), but not to days of drug use in the last 90 days (P = .14). ","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sanchez', 'Affiliation': 'a School of Social Work , The University of Texas at Arlington , Arlington , Texas , USA.'}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Greer', 'Affiliation': ''}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Grannemann', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': ''}]",Substance abuse,['10.1080/08897077.2014.937845'] 1450,24229749,Treating nicotine dependence by targeting attention-deficit/ hyperactivity disorder (ADHD) with OROS methylphenidate: the role of baseline ADHD severity and treatment response.,"OBJECTIVE To determine whether treatment of attention-deficit/hyperactivity disorder (ADHD) with osmotic-release oral system (OROS) methylphenidate promotes abstinence from smoking among smokers with ADHD who have greater severity of ADHD symptoms at baseline or greater improvement in ADHD during treatment. METHOD This is a secondary analysis of data from a randomized, double-blind, 11-week trial conducted between December 2005 and January 2008 at 6 clinical sites; the original trial was sponsored by the National Drug Abuse Clinical Trials Network. Adult cigarette smokers (aged 18-55 years) who met DSM-IV criteria for ADHD were randomly assigned to OROS methylphenidate (72 mg/d) (n = 127) or matching placebo (n = 128). All participants received nicotine patches (21 mg/d) and weekly individual smoking cessation counseling. Logistic regression was used to model prolonged abstinence from smoking (ascertained by self-report and breath carbon monoxide testing) as a function of treatment, baseline ADHD Rating Scale-IV (ADHD-RS) score, change in ADHD-RS score during treatment, and their interactions. RESULTS Treatment interacted with both ADHD-RS score at baseline (P = .01) and change in ADHD-RS score during treatment (P = .008). Among patients with higher ADHD-RS scores (> 36) at baseline and the most improvement in ADHD during treatment (ADHD-RS change score ≥ 24), 70.0% of those who took OROS methylphenidate achieved abstinence from smoking compared to 36.8% of those who took placebo (P = .02). In contrast, among patients with the lowest ADHD-RS baseline scores (≤ 30), 30.3% of those who took OROS methylphenidate achieved abstinence from smoking compared to 60.7% of those who took placebo (P = .02). CONCLUSIONS OROS methylphenidate, in combination with nicotine patch, may be an effective treatment for nicotine dependence among smokers with more severe ADHD and more robust response of ADHD symptoms to medication. OROS methylphenidate may be counterproductive among smokers with lower severity of ADHD. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00253747.",2013,"RESULTS Treatment interacted with both ADHD-RS score at baseline (P = .01) and change in ADHD-RS score during treatment (P = .008).","['smokers with ADHD who have greater severity of ADHD symptoms at baseline or greater improvement in ADHD during treatment', 'Adult cigarette smokers (aged 18-55 years) who met DSM-IV criteria for ADHD', 'December 2005 and January 2008 at 6 clinical sites; the original trial was sponsored by the National Drug Abuse Clinical Trials Network', 'smokers with lower severity of ADHD']","['OROS methylphenidate', 'osmotic-release oral system (OROS) methylphenidate', 'matching placebo', 'placebo', 'nicotine patches', 'individual smoking cessation counseling', 'nicotine patch']","['abstinence from smoking', 'change in ADHD-RS score', 'ADHD-RS score', 'baseline ADHD Rating Scale-IV (ADHD-RS) score, change in ADHD-RS score']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",,0.120895,"RESULTS Treatment interacted with both ADHD-RS score at baseline (P = .01) and change in ADHD-RS score during treatment (P = .008).","[{'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, 1051 Riverside Drive, Unit 51, Room 3717, New York, NY 10032 nunesed@nyspi.columbia.edu.'}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': ''}, {'ForeName': 'Eugene C', 'Initials': 'EC', 'LastName': 'Somoza', 'Affiliation': ''}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.12m08155'] 1451,24106976,Family discord is associated with increased substance use for pregnant substance users.,"Childhood abuse and partner violence are associated with prenatal substance abuse, but the potential impact of current family discord, which reflects broader family relationships and encompasses problems less severe than violence, has had little evaluation in pregnant substance users. Using data from 196 pregnant substance users participating in a NIDA Clinical Trials Network randomized clinical trial, we examined the relationship of baseline family discord to substance use and treatment session attendance. Family discord was assessed using items from the family composite of the Addiction Severity Index. Substance use was assessed by the Substance Use Calendar and urine drug screens (UDS). Assessments were weekly for four weeks and at two- and four-month post-randomization. Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month. Specific treatment interventions targeting pregnant women with family discord may be warranted.",2014,"Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month.","['196 pregnant substance users participating in a NIDA Clinical Trials Network randomized clinical trial', 'pregnant women with family discord', 'pregnant substance users']",[],['positive UDS'],"[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0338666', 'cui_str': 'Drug Users'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",196.0,0.0502409,"Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month.","[{'ForeName': 'Wayne H', 'Initials': 'WH', 'LastName': 'Denton', 'Affiliation': '1Florida State University, Family and Child Sciences , Tallahassee, Florida , USA.'}, {'ForeName': 'Bryon H', 'Initials': 'BH', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Substance use & misuse,['10.3109/10826084.2013.840002'] 1452,32059724,Why do family dementia caregivers reject caregiver support services? Analyzing types of rejection and associated health-impairments in a cluster-randomized controlled intervention trial.,"BACKGROUND Although there are a number of support services accessible for most family dementia caregivers, many caregivers reject available and affordable support. Previous research suggests that rejections of support services may result from insufficient fit of available services with caregivers' unmet needs and a lack of acknowledgement of caregivers' unmet needs and associated support services. The present study investigates (a) the number, proportion and types of caregivers' rejection on recommended tailored support, (b) socio-demographic and clinical determinants of caregiver's rejection of both people with dementia (PwD) and caregivers, and (c) caregivers' health-related variables related to caregivers' rejection. METHODS Caregivers' rejection of tailored support services was identified based on a standardized, computerized unmet needs assessment conducted by dementia-specific qualified nurses. The present analysis is based on data of n = 226 dyads of caregivers and their community-dwelling PwD who participated in a general practitioner (GP)-based, cluster-randomized intervention trial. The trial was approved by the Ethical Committee of the Chamber of Physicians of Mecklenburg-Western Pomerania, registry number BB 20/11. Data analyses were conducted using Stata/IC 13.1. We conducted Welch's t-test, Pearson's product-moment correlation, and conditional negative binomial regression models with random effects for GP to account for over-dispersed count data. RESULTS In sum, n = 505 unmet needs were identified and the same number of tailored recommendations were identified for n = 171 family dementia caregivers from the intervention group at baseline. For n = 55 family dementia caregivers not a single unmet need and recommendation were identified. A total of 17.6% (n = 89) of the recommendations were rejected by caregivers. Rejection rates of caregivers differed by type of recommendation. Whereas caregivers' rejection rate on recommendations concerning mental health (3.6%), physical health (2.5%), and social, legal, and financial affairs (0%) were low, caregivers' rejection rates concerning social integration (especially caregiver supporting groups) was high (71.7%). Thus, the rejections of family dementia caregivers are mainly linked to the delegation to caregiver supporting groups. Caregivers' rejections were mainly related to personal factors of caregivers (n = 66), service-related factors (n = 6), relational factors (n = 1), and other factors (n = 17). Furthermore, our results showed that the number of caregivers' rejections was associated with a higher functional status of the PwD and are mainly associated with the rejection of caregiver supporting groups. Thus, caregivers visit supporting groups more often when the PwD shows low abilities in activities of daily living. Importantly, this is independent of the status of cognition and depression of the PwD as well as the physical and mental health of the family dementia caregivers. CONCLUSIONS Our results underline the importance of understanding factors that determine caregivers' rejection of support services. These need to be specifically addressed in tailored solutions for caregivers' support services. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01401582 (date: July 25, 2011, prospective registered).",2020,"Whereas caregivers' rejection rate on recommendations concerning mental health (3.6%), physical health (2.5%), and social, legal, and financial affairs (0%) were low, caregivers' rejection rates concerning social integration (especially caregiver supporting groups) was high (71.7%).","['n\u2009=\u2009226 dyads of caregivers and their community-dwelling PwD who participated in a general practitioner (GP)-based, cluster-randomized intervention trial', ""people with dementia (PwD) and caregivers, and (c) caregivers' health-related variables related to caregivers' rejection"", ""Caregivers' rejection of tailored support services was identified based on a standardized, computerized unmet needs assessment conducted by dementia-specific qualified nurses""]",[],"['physical health', 'Rejection rates']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0558005', 'cui_str': 'Needs Assessment'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]",,0.044246,"Whereas caregivers' rejection rate on recommendations concerning mental health (3.6%), physical health (2.5%), and social, legal, and financial affairs (0%) were low, caregivers' rejection rates concerning social integration (especially caregiver supporting groups) was high (71.7%).","[{'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Zwingmann', 'Affiliation': 'European University of Applied Science (EUFH), Werftstrasse 5, 18057, Rostock, Germany. i.zwingmann@eufh.de.'}, {'ForeName': 'Adina', 'Initials': 'A', 'LastName': 'Dreier-Wolfgramm', 'Affiliation': 'University of Applied Science Hamburg, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Esser', 'Affiliation': 'German Alzheimer Association regional association Mecklenburg-Western Pomerania, Rostock, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Wucherer', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Jochen René', 'Initials': 'JR', 'LastName': 'Thyrian', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Tilly', 'Initials': 'T', 'LastName': 'Eichler', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Kaczynski', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Monsees', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Keller', 'Affiliation': 'German Alzheimer Association regional association Mecklenburg-Western Pomerania, Rostock, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Kilimann', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Teipel', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Michalowsky', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hoffmann', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Rostock, Germany.'}]",BMC health services research,['10.1186/s12913-020-4970-8'] 1453,32421603,Efficacy and cost-effectiveness of intensive short-term dynamic psychotherapy for treatment resistant depression: 18-Month follow-up of the Halifax depression trial.,"BACKGROUND Depressed patients with chronic and complex health issues commonly relapse; therefore, examining longer-term outcomes is an important consideration. For treatment resistant depression (TRD), the post-treatment efficacy of time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP) has been demonstrated but longer-term outcomes and cost-effectiveness are unclear. METHOD In this superiority trial, 60 patients referred to Community Mental Health Teams (CMHT) were randomised to 2 groups (ISTDP=30 and CMHT=30). The primary outcome was Hamilton Depression Rating scale (HAM-D) scores at 18 months. Secondary outcomes included Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission. A health economic evaluation examined mental health costs with quality-adjusted life years (QALYs). RESULTS Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up. Group differences in depression were in the moderate to large range on both the observer rated (Cohen's d = .64) and self-report measures (Cohen's d = .70). At 18 months follow-up the remission rate in ISTDP patients was 40.0%, and 23.4% had discontinued antidepressants. Health economic analysis suggests that ISTDP was more cost-effective than CMHT at 18 months. Probabilistic analysis suggests that there is a 64.5% probability of ISTDP being cost-effective at a willingness to pay for a QALY of $25,000 compared to CMHT at 18 months. LIMITATIONS Replication of these findings is necessary in larger samples and future cost analyses should also consider indirect costs. CONCLUSIONS ISTDP demonstrates long-term efficacy and cost-effectiveness in TRD.",2020,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,['60 patients referred to Community Mental Health Teams (CMHT'],"['ISTDP', 'intensive short-term dynamic psychotherapy', 'time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP']","['Hamilton Depression Rating scale (HAM-D) scores', 'Efficacy and cost-effectiveness', 'Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission', 'remission rate', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",60.0,0.0697056,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,"[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada. Electronic address: joel.town@dal.ca.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'The Institute of Work Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry & Faculty of Computer Science, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernier', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berrigan', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.04.035'] 1454,32421440,Implementation of Minimally Invasive Esophagectomy From a Randomized Controlled Trial Setting to National Practice.,"PURPOSE The aim of this study was to examine the external validity of the randomized TIME trial, when minimally invasive esophagectomy (MIE) was implemented nationally in the Netherlands, using data from the Dutch Upper GI Cancer Audit (DUCA) for transthoracic esophagectomy. METHODS Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017). Multivariate analysis, with adjustment for patient factors, tumor factors, and year of surgery, was performed for the effect of MIE versus open esophagectomy on clinical outcomes. RESULTS One hundred fifteen patients from the TIME trial (59 MIE v 56 open) and 4,605 patients from the DUCA dataset (2,652 MIE v 1,953 open) were included. In the TIME trial, univariate analysis showed that MIE reduced pulmonary complications and length of hospital stay. On the contrary, in the DUCA dataset, MIE was associated with increased total and pulmonary complications and reoperations; however, benefits included increased proportion of R0 margin and lymph nodes harvested, and reduced 30-day mortality. Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61). In the DUCA dataset, MIE was associated with increased total complications (OR, 1.36; 95% CI, 1.19 to 1.57), pulmonary complications (OR, 1.50; 95% CI, 1.29 to 1.74), reoperations (OR, 1.74; 95% CI, 1.42 to 2.14), and length of hospital stay. Multivariate analysis of the combined and MIE datasets showed that inclusion in the TIME trial was associated with a reduction in reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay. CONCLUSION When adopted nationally outside the TIME trial, MIE was associated with an increase in total and pulmonary complications and reoperation rate. This may reflect nonexpert surgeons outside of high-volume centers performing this minimally invasive technique in a nonstandardized fashion outside of a controlled environment.",2020,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","['Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017', 'One hundred fifteen patients from the TIME trial (59 MIE v 56 open) and 4,605 patients from the DUCA dataset ']","['MIE versus open esophagectomy', 'Minimally Invasive Esophagectomy', 'minimally invasive esophagectomy (MIE']","['total complications', 'total and pulmonary complications and reoperation rate', 'pulmonary complications', 'pulmonary complications and length of hospital stay', 'length of hospital stay', 'reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay', '30-day mortality', 'total and pulmonary complications and reoperations', 'MIE reduced pulmonary complications']","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",115.0,0.249686,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","[{'ForeName': 'Sheraz R', 'Initials': 'SR', 'LastName': 'Markar', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'van der Werf', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Straatman', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Hanna', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02483'] 1455,23305820,Impulsivity is associated with treatment non-completion in cocaine- and methamphetamine-dependent patients but differs in nature as a function of stimulant-dependence diagnosis.,"Greater impulsivity, assessed by the Barratt Impulsiveness Scale-11 (BIS-11) and Stroop interference scores, has been associated with treatment completion in cocaine-dependent patients. This study evaluated the relationships among impulsivity, stimulant-dependence diagnosis, and treatment completion. Six sites evaluating 12-step facilitation for stimulant abusers obtained the BIS-11 and Stroop from 182 methamphetamine- and/or cocaine-dependent participants. Methamphetamine-dependent, relative to cocaine-dependent, participants evidenced significantly greater BIS-11 non-planning and total scores. There was a trend for poorer response inhibition, measured by the Stroop, in cocaine-dependent, relative to methamphetamine-dependent, participants. Accounting for other factors related to treatment completion, BIS-11 motor score, assessing the tendency to act without thinking, predicted treatment completion for both cocaine-dependent and methamphetamine-dependent patients. These results suggest that methamphetamine-dependent and cocaine-dependent patients may have different impulsivity profiles but that the BIS-11 may be useful in identifying both methamphetamine-dependent and cocaine-dependent patients who are at risk for treatment non-completion.",2013,"There was a trend for poorer response inhibition, measured by the Stroop, in cocaine-dependent, relative to methamphetamine-dependent, participants.",['stimulant abusers obtained the BIS-11 and Stroop from 182 methamphetamine- and/or cocaine-dependent participants'],"['methamphetamine', 'Methamphetamine']","['Greater impulsivity', 'Impulsivity', 'poorer response inhibition', 'BIS-11 non-planning and total scores', 'Barratt Impulsiveness Scale-11 (BIS-11) and Stroop interference scores']","[{'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0222045'}]",,0.0299686,"There was a trend for poorer response inhibition, measured by the Stroop, in cocaine-dependent, relative to methamphetamine-dependent, participants.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH 45220, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': ''}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Seamans', 'Affiliation': ''}, {'ForeName': 'Candace C', 'Initials': 'CC', 'LastName': 'Hodgkins', 'Affiliation': ''}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Dicenzo', 'Affiliation': ''}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Botero', 'Affiliation': ''}, {'ForeName': 'Davina R', 'Initials': 'DR', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Somoza', 'Affiliation': ''}]",Journal of substance abuse treatment,['10.1016/j.jsat.2012.12.005'] 1456,22936099,Effects of magnitude and magnitude predictability of postural perturbations on preparatory cortical activity in older adults with and without Parkinson's disease.,"The goal of this study was to identify whether impaired cortical preparation may relate to impaired scaling of postural responses of people with Parkinson's disease (PD). We hypothesized that impaired scaling of postural responses in participants with PD would be associated with impaired set-dependent cortical activity in preparation for perturbations of predictable magnitudes. Participants performed postural responses to backward surface translations. We examined the effects of perturbation magnitude (predictable small vs. predictable large) and predictability of magnitude (predictable vs. unpredictable-in-magnitude) on postural responses (center-of-pressure (CoP) displacements) and on preparatory electroencephalographic (EEG) measures of contingent negative variation (CNV) and alpha and beta event-related desynchronization (ERD). Our results showed that unpredictability of perturbation magnitude, but not the magnitude of the perturbation itself, was associated with increased CNV amplitude at the CZ electrode in both groups. While control participants scaled their postural responses to the predicted magnitude of the perturbation, their condition-related changes in CoP displacements were not correlated with condition-related changes in EEG preparatory activity (CNV or ERD). In contrast, participants with PD did not scale their postural responses to the predicted magnitude of the perturbation, but they did demonstrate greater beta ERD in the condition of predictably small-magnitude perturbations and greater beta ERD than the control participants at the CZ electrode. In addition, increased beta ERD in PD was associated with decreased adaptability of postural responses, suggesting that preparatory cortical activity may have a more direct influence on postural response scaling for people with PD than for control participants.",2012,"While control participants scaled their postural responses to the predicted magnitude of the perturbation, their condition-related changes in CoP displacements were not correlated with condition-related changes in EEG preparatory activity (CNV or ERD).","[""people with Parkinson's disease (PD"", ""older adults with and without Parkinson's disease"", 'participants with PD']",['postural perturbations'],"['CoP displacements', 'preparatory electroencephalographic (EEG) measures of contingent negative variation (CNV) and alpha and beta event-related desynchronization (ERD', 'CNV amplitude', 'EEG preparatory activity (CNV or ERD', 'postural response scaling', 'adaptability of postural responses', 'postural responses (center-of-pressure (CoP) displacements']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]","[{'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009850', 'cui_str': 'Contingent Negative Variation'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",,0.0385319,"While control participants scaled their postural responses to the predicted magnitude of the perturbation, their condition-related changes in CoP displacements were not correlated with condition-related changes in EEG preparatory activity (CNV or ERD).","[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Smith', 'Affiliation': 'Balance Disorders Laboratory, Departments of Neurology and Behavioral Neuroscience, Oregon Health and Science University, 505 NW 185th Ave., Beaverton, OR 97006, USA. smitbeth@ohsu.edu'}, {'ForeName': 'Jesse V', 'Initials': 'JV', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': ''}]",Experimental brain research,['10.1007/s00221-012-3232-3'] 1457,22889694,Predictors of treatment response in adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder.,"Attention-Deficit/Hyperactivity Disorder (ADHD) frequently co-occurs with substance use disorder (SUD) and is associated with poor substance-use treatment outcomes. A trial evaluating osmotic-release oral system methylphenidate (OROS-MPH) for adolescents with ADHD and SUD, concurrently receiving behavioral therapy, revealed inconsistent medication effects on ADHD or SUD. Clinical care for this population would be advanced by knowledge of treatment outcome predictors. Data from the randomized placebo-controlled trial (n = 299) were analyzed. Significant treatment predictors included: 1) Substance use severity, associated with poorer ADHD and SUD outcomes, 2) ADHD severity, associated with better ADHD and SUD outcomes, 3) comorbid conduct disorder, associated with poorer ADHD outcomes, and 4) court-mandated status, associated with better SUD outcomes but poorer treatment completion. An interaction effect showed that OROS-MPH improved SUD outcomes in adolescents with comorbid conduct disorder compared to placebo. While severe SUD may require more intensive psychosocial treatment, OROS-MPH may improve substance treatment outcomes in adolescents with co-morbid attention and conduct problems.",2013,"A trial evaluating osmotic-release oral system methylphenidate (OROS-MPH) for adolescents with ADHD and SUD, concurrently receiving behavioral therapy, revealed inconsistent medication effects on ADHD or SUD.","['adolescents with ADHD and SUD', 'adolescents with co-morbid attention and conduct problems', 'adolescents with comorbid conduct disorder', 'adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder']","['OROS-MPH', 'placebo', 'osmotic-release oral system methylphenidate (OROS-MPH']","['SUD outcomes', ' 1) Substance use severity, associated with poorer ADHD and SUD outcomes, 2) ADHD severity, associated with better ADHD and SUD outcomes, 3) comorbid conduct disorder, associated with poorer ADHD outcomes, and 4) court-mandated status, associated with better SUD outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0149654', 'cui_str': 'Conduct Disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0149654', 'cui_str': 'Conduct Disorder'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",299.0,0.101792,"A trial evaluating osmotic-release oral system methylphenidate (OROS-MPH) for adolescents with ADHD and SUD, concurrently receiving behavioral therapy, revealed inconsistent medication effects on ADHD or SUD.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. leanne.tamm@cchmc.org""}, {'ForeName': 'Kathlene', 'Initials': 'K', 'LastName': 'Trello-Rishel', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Riggs', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Nakonezny', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Acosta', 'Affiliation': ''}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Journal of substance abuse treatment,['10.1016/j.jsat.2012.07.001'] 1458,31916941,Tracheal intubation in microgravity: a simulation study comparing direct laryngoscopy and videolaryngoscopy † .,"BACKGROUND The risk of severe medical and surgical events during long-duration spaceflight is significant. In space, many environmental and psychological factors may make tracheal intubation more difficult than on Earth. We hypothesised that, in microgravity, tracheal intubation may be facilitated by the use of a videolaryngoscope compared with direct laryngoscopy. METHODS In a non-randomised, controlled, cross-over simulation study, we compared intubation performance of novice operators and experts, using either a direct laryngoscope or a videolaryngoscope, in weightlessness and in normogravity. The primary outcome was the success rate of tracheal intubation. Time to intubation and the confidence score into the success of tube placement were also recorded. RESULTS When novices attempted to intubate the trachea in microgravity, the success rate of tracheal intubation using a videolaryngoscope was significantly higher (20/25 [80%]; 95% confidence interval [CI], 64.3-95.7 vs eight/20 [40%]; 95% CI, 18.5-61.5; P=0.006), and intubation time was shorter, compared with using a direct laryngoscope. In normogravity, the success rate of tracheal intubation by experts was significantly higher than that by novices (16/20 [80%]; 95% CI, 62.5-97.5 vs seven/25 [28%]; 95% CI, 10.4-45.6; P=0.001), but in microgravity, there was no significant difference between the experts and novices (19/20 [95%]; 95% CI, 85.4-100 vs 20/25 [80%]; 95% CI, 64.3-95.7; P=0.113). Higher confidence scores were achieved with videolaryngoscopy compared with direct laryngoscopy by both experts and novices in both microgravity and normogravity. CONCLUSIONS Videolaryngoscopy was associated with higher intubation success rate and speed, and higher confidence for correct tube placement by novice operators in microgravity, and as such may represent the best technique for advanced airway management during long-duration spaceflight.",2020,"Higher confidence scores were achieved with videolaryngoscopy compared with direct laryngoscopy by both experts and novices in both microgravity and normogravity. ",['Tracheal intubation in microgravity'],"['videolaryngoscopy', 'direct laryngoscopy and videolaryngoscopy † ']","['intubation time', 'Time to intubation and the confidence score into the success of tube placement', 'success rate of tracheal intubation']","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0242535', 'cui_str': 'Microgravity'}]","[{'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",,0.245476,"Higher confidence scores were achieved with videolaryngoscopy compared with direct laryngoscopy by both experts and novices in both microgravity and normogravity. ","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Starck', 'Affiliation': 'Anesthesiology and Intensive Care Department, University Hospital of Brest, Brest, France; Space Medicine Group, European Society of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Séamus', 'Initials': 'S', 'LastName': 'Thierry', 'Affiliation': 'Space Medicine Group, European Society of Aerospace Medicine, Cologne, Germany; Anesthesiology Department, South Brittany General Hospital, Lorient, France; Laboratoire Psychologie, Cognition, Communication, Comportement, Université Bretagne Sud, Vannes, France. Electronic address: s.thierry@ghbs.bzh.'}, {'ForeName': 'Cécile Isabelle', 'Initials': 'CI', 'LastName': 'Bernard', 'Affiliation': 'Laboratoire Psychologie, Cognition, Communication, Comportement, Université Bretagne Sud, Vannes, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Morineau', 'Affiliation': 'Laboratoire Psychologie, Cognition, Communication, Comportement, Université Bretagne Sud, Vannes, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jaulin', 'Affiliation': 'Sorbonne Medical University, Assistance Publique des Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chapelain', 'Affiliation': 'Medical Simulation Center C3S, Lorient, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Komorowski', 'Affiliation': 'Space Medicine Group, European Society of Aerospace Medicine, Cologne, Germany; Department of Surgery and Cancer, Imperial College London, London, UK.'}]",British journal of anaesthesia,['10.1016/j.bja.2019.11.029'] 1459,24999283,Identifying patients with problematic drug use in the emergency department: results of a multisite study.,"STUDY OBJECTIVE Drug-related emergency department (ED) visits have steadily increased, with substance users relying heavily on the ED for medical care. The present study aims to identify clinical correlates of problematic drug use that would facilitate identification of ED patients in need of substance use treatment. METHODS Using previously validated tests, 15,224 adult ED patients across 6 academic institutions were prescreened for drug use as part of a large randomized prospective trial. Data for 3,240 participants who reported drug use in the past 30 days were included. Self-reported variables related to demographics, substance use, and ED visit were examined to determine their correlative value for problematic drug use. RESULTS Of the 3,240 patients, 2,084 (64.3%) met criteria for problematic drug use (Drug Abuse Screening Test score ≥ 3). Age greater than or equal to 30 years, tobacco smoking, daily or binge alcohol drinking, daily drug use, primary noncannabis drug use, resource-intense ED triage level, and perceived drug-relatedness of ED visit were highly correlated with problematic drug use. Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use. CONCLUSION Clinical correlates of drug use problems may assist the identification of ED patients who would benefit from comprehensive screening, intervention, and referral to treatment. A clinical decision rule is proposed. The correlation between problematic drug use and resource-intense ED triage levels suggests that ED-based efforts to reduce the unmet need for substance use treatment may help decrease overall health care costs.",2014,"Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use. ","['Identifying patients with problematic drug use in the emergency department', '3,240 participants who reported drug use in the past 30 days were included', 'ED patients who would benefit from comprehensive screening, intervention, and referral to treatment', 'Of the 3,240 patients, 2,084 (64.3%) met criteria for problematic drug use (Drug Abuse Screening Test score ≥ 3', 'primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use', '15,224 adult ED patients across 6 academic institutions']",[],"['tobacco smoking, daily or binge alcohol drinking, daily drug use, primary noncannabis drug use, resource-intense ED triage level']","[{'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451130', 'cui_str': 'Drug abuse screening test (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]",[],"[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",15224.0,0.0486456,"Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use. ","[{'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Macias Konstantopoulos', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA; Harvard Medical School, Boston, MA. Electronic address: wmacias@mgh.harvard.edu.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Dreifuss', 'Affiliation': 'Department of Psychiatrys, Boston, MA; Harvard Medical School, Boston, MA; Behavioral Health Partial Program, McLean Hospital, Belmont, MA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'McDermott', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA.'}, {'ForeName': 'Blair Alden', 'Initials': 'BA', 'LastName': 'Parry', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Howell', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Raul N', 'Initials': 'RN', 'LastName': 'Mandler', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, MA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bogenschutz', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatrys, Boston, MA; Harvard Medical School, Boston, MA; Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2014.05.012'] 1460,24911028,"Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.","OBJECTIVE To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. METHOD A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. RESULTS There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²₁ = 15.26, P < .0001), reflecting an increase in cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n = 39; χ²₁ = 0.14, P = .70). CONCLUSIONS The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01641159.",2014,There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use.,"['Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase', '6 clinical sites between August 2012 and June 2013', 'cocaine dependence']","['buspirone', 'placebo']","['maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085163', 'cui_str': 'Crack Cocaine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",,0.274459,There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use.,"[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'University of Cincinnati, Department of Psychiatry, 3131 Harvey Ave, Cincinnati, OH 45229 winhust@uc.edu.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Hodgkins', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chartier', 'Affiliation': ''}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': ''}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'VanVeldhuisen', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'May', 'Affiliation': ''}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.13m08862'] 1461,24128381,Achieving smoking abstinence is associated with decreased cocaine use in cocaine-dependent patients receiving smoking-cessation treatment.,"BACKGROUND Past research suggests that a significant relationship exists between cigarette smoking and illicit-stimulant abuse. The present study evaluated the association between achieving smoking abstinence in response to smoking-cessation treatment (SCT) and illicit-stimulant abstinence in cocaine- and/or methamphetamine-dependent participants. METHODS Secondary analysis of a randomized, 10-week trial conducted at 12 substance use disorder (SUD) treatment programs. Two hundred and sixty seven adults, meeting DSM-IV-TR criteria for cocaine and/or methamphetamine-dependence and interested in quitting smoking were randomized to SUD treatment as usual plus SCT consisting of weekly individual smoking cessation counseling, extended-release (XL) bupropion (300 mg/day), nicotine inhaler, and contingency management for smoking abstinence. Illicit-stimulant-abstinence was measured by self-report and urine drug screens. Smoking abstinence was assessed via self-report and carbon monoxide levels. RESULTS A significant effect was found for the cocaine-dependent subsample (N=147) in which participants who stopped smoking were abstinent for illicit stimulants an average of 78.2% of the post-smoking-quit weeks (weeks 4-10) relative to 63.6% in participants who continued smoking (X(2)(1)=8.55, p<.01, d=0.36). No significant effects were found for the sample as a whole (N=249) or for the methamphetamine-dependent subsample (N=102). CONCLUSIONS The present results suggest that cocaine-dependent patients achieving smoking abstinence in response to SCT might evidence not only improved smoking outcomes but improved cocaine-use outcomes as well. Future research to replicate this finding appears warranted.",2014,"No significant effects were found for the sample as a whole (N=249) or for the methamphetamine-dependent subsample (N=102). ","['dependent participants', '12 substance use disorder (SUD) treatment programs', 'Two hundred and sixty seven adults, meeting DSM-IV-TR criteria for cocaine and/or methamphetamine-dependence and interested in quitting smoking']","['methamphetamine', 'nicotine inhaler, and contingency management for smoking abstinence', 'SUD treatment as usual plus SCT consisting of weekly individual smoking cessation counseling, extended-release (XL) bupropion', 'smoking-cessation treatment (SCT) and illicit-stimulant abstinence in cocaine']","['Illicit-stimulant-abstinence', 'smoking outcomes', 'Smoking abstinence']","[{'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0814019', 'cui_str': 'Nicotine inhaler'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0195245,"No significant effects were found for the sample as a whole (N=249) or for the methamphetamine-dependent subsample (N=102). ","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA. Electronic address: winhust@ucmail.uc.edu.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2013.09.019'] 1462,23808868,"Preliminary evaluation of a model of stimulant use, oxidative damage and executive dysfunction.","BACKGROUND Illicit stimulant use increases oxidative stress and oxidative stress has been found to be associated with deficits in memory, attention and problem-solving. OBJECTIVE To test a model of the association among oxidative DNA damage, a severe form of oxidative stress, and stimulant use, executive function and stimulant-use outcomes. METHODS Six sites evaluating 12-step facilitation for stimulant abusers obtained peripheral blood samples from methamphetamine-dependent (n = 45) and cocaine-dependent (n = 120) participants. The blood samples were submitted to a comet assay to assess oxidative DNA damage. Executive Dysfunction was assessed with the Frontal Systems Behavior Scale (FrSBe), which is a reliable and valid self-report assessment of executive dysfunction, disinhibition and apathy. Stimulant-use measures included self-reported stimulant use and stimulant urine drug screens (UDS). RESULTS While more recent cocaine use (<30 days abstinence) was associated with greater oxidative DNA damage (W = 2.4, p < 0.05, d = 0.36), the results did not support the hypothesized relationship between oxidative DNA damage, executive dysfunction and stimulant use outcomes for cocaine-dependent patients. Support for the model was found for methamphetamine-dependent patients, with oxidative DNA damage significantly greater in methamphetamine-dependent patients with executive dysfunction (W = 2.2, p < 0.05, d = 0.64) and with executive dysfunction being a significant mediator of oxidative DNA damage and stimulant use during active treatment (ab = 0.089, p < 0.05). As predicted, neither disinhibition nor apathy were significant mediators of oxidative damage and future stimulant use. CONCLUSION These findings provide preliminary support for a model in which oxidative damage resulting from methamphetamine use results in executive dysfunction, which in turn increases vulnerability to future stimulant use.",2013,"While more recent cocaine use (<30 days abstinence) was associated with greater oxidative DNA damage (W = 2.4, p < 0.05, d = 0.36), the results did not support the hypothesized relationship between oxidative DNA damage, executive dysfunction and stimulant use outcomes for cocaine-dependent patients.",['Six sites evaluating 12-step facilitation for stimulant abusers obtained peripheral blood samples from methamphetamine-dependent (n\u2009=\u200945) and cocaine-dependent (n\u2009=\u2009120) participants'],[],"['Frontal Systems Behavior Scale (FrSBe', 'Executive Dysfunction', 'oxidative damage and executive dysfunction', 'oxidative DNA damage']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]",[],"[{'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}]",120.0,0.026922,"While more recent cocaine use (<30 days abstinence) was associated with greater oxidative DNA damage (W = 2.4, p < 0.05, d = 0.36), the results did not support the hypothesized relationship between oxidative DNA damage, executive dysfunction and stimulant use outcomes for cocaine-dependent patients.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Somoza', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Somoza', 'Affiliation': ''}]",The American journal of drug and alcohol abuse,['10.3109/00952990.2013.798663'] 1463,32422244,"Implementation of basic life support training for school children: Online education for potential instructors? Results of a cluster randomised, controlled, non-inferiority trial.","AIM OF THE STUDY Comprehensive training of the population in basic life support (BLS) increases the chance of survival in cardiac arrest. To implement BLS trainings at schools a high number of instructors will be needed. This non-inferiority study investigated, if online education is effective to prepare instructors to teach BLS compared to face-to-face education. METHODS A cluster randomised, controlled, single blinded study was performed in 2018 in Hamburg, Germany. A mixed group of potential instructors were allocated alternately to either the intervention or control group and participated in a four-hour instructor training. The instructor training of the control group was realised by trained educators. The intervention group participated in a self-regulated online training with hands-on training supported by peers. Instructors provided BLS training for high school students. The primary endpoint was a mean score in the BLS skills assessment of the students. The secondary endpoint was teaching effectiveness of the instructors. RESULTS BLS assessments of 808 students of 46 classes, who were taught by 74 instructors could be analysed. The students trained by interventional instructors achieved 0.14 points less (95% CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48). The non-inferiority could not be confirmed. The teaching performance in the intervention group was better in some aspects compared to the control group. CONCLUSION Integrating all results of this study, online education may be an effective alternative to prepare potential BLS instructors. Using free online courses, motivated persons can independently acquire necessary skills to become instructors and autonomously realise low cost BLS trainings at schools.",2020,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"['808 students of 46 classes, who were taught by 74 instructors could be analysed', '2018 in Hamburg, Germany', 'high school students', 'school children']","['Basic life support training', 'BLS training', 'self-regulated online training with hands-on training supported by peers', 'intervention or control group and participated in a four-hour instructor training']","['mean score in the BLS skills assessment of the students', 'teaching effectiveness of the instructors']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",,0.042077,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Kosan', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hoffend', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Breitfeld', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Doehn', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kubitz', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany. Electronic address: st.beck@uke.de.'}]",Resuscitation,['10.1016/j.resuscitation.2020.04.041'] 1464,25369890,Calcifediol versus vitamin D3 effects on gait speed and trunk sway in young postmenopausal women: a double-blind randomized controlled trial.,"UNLABELLED In this double-blind RCT, 4-month treatment with calcifediol compared with vitamin D3 improved gait speed by 18% among young postmenopausal women. Consistently, change in 25(OH)D blood levels over time were significantly correlated with improvement in gait speed in these women. No effect could be demonstrated for trunk sway. INTRODUCTION The aim of this study is to test the effect of calcifediol compared with vitamin D3 on gait speed and trunk sway. METHODS Twenty healthy postmenopausal women with an average 25(OH)D level of 13.2 ng/ml (SD = ±3.9) and a mean age of 61.5 years (SD = ±7.2) were randomized to either 20 μg of calcifediol or 20 μg (800 IU) of vitamin D3 per day in a double-blind manner. At baseline and at 4 months of follow-up, the same physiotherapist blinded to treatment allocation tested 8-m gait speed and a body sway test battery (Sway star pitch and roll angle plus velocity while walking 8 m, and standing on both legs on a hard and soft surface). All analyses adjusted for baseline measurement, age, and body mass index. RESULTS Mean 25(OH)D levels increased to 69.3 ng/ml (SD = ±9.5) in the calcifediol group and to 30.5 ng/ml (SD = ±5.0) in the vitamin D3 group (p < 0.0001). Women receiving calcifediol compared with vitamin D3 had an 18% greater improvement in gait speed at 4-month follow-up (p = 0.046) adjusting for baseline gait speed, age, and body mass index. Also, change in gait speed was significantly correlated with change in serum 25(OH)D concentrations (r = 0.5; p = 0.04). Across three tests of trunk sway, there were no consistent differences between groups and no significant correlation between change in 25(OH)D serum concentrations and change in trunk sway. CONCLUSIONS Calcifediol improved gait speed in early postmenopausal women compared with vitamin D3 and change in 25(OH)D level was moderately correlated with improvement in gait speed. A benefit on trunk sway could not be demonstrated.",2015,Mean 25(OH)D levels increased to 69.3 ng/ml (SD = ±9.5) in the calcifediol group and to 30.5 ng/ml (SD = ±5.0) in the vitamin D3 group (p < 0.0001).,"['young postmenopausal women', 'early postmenopausal women', 'Twenty healthy postmenopausal women with an average 25(OH)D level of 13.2 ng/ml (SD\u2009=\u2009±3.9) and a mean age of 61.5 years (SD\u2009=\u2009±7.2']","['gait speed and a body sway test battery (Sway star pitch and roll angle plus velocity while walking 8 m, and standing on both legs on a hard and soft surface', 'calcifediol', 'Calcifediol versus vitamin D3', 'vitamin D3']","['25(OH)D blood levels', 'change in gait speed', 'serum 25(OH)D concentrations', '25(OH)D serum concentrations and change in trunk sway', 'trunk sway', 'gait speed', '25(OH)D level', 'gait speed and trunk sway', 'Mean 25(OH)D levels']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",20.0,0.421858,Mean 25(OH)D levels increased to 69.3 ng/ml (SD = ±9.5) in the calcifediol group and to 30.5 ng/ml (SD = ±5.0) in the vitamin D3 group (p < 0.0001).,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Meyer', 'Affiliation': 'Geriatric Clinic, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sidelnikov', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Grob', 'Affiliation': ''}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Staehelin', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Theiler', 'Affiliation': ''}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Kressig', 'Affiliation': ''}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Simmen', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': ''}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-014-2949-1'] 1465,24932624,Application of Peak Nasal Inspiratory Flow reference values in the treatment of allergic rhinitis.,"OBJECTIVE To assess the applicability of the Peak Nasal Inspiratory Flow (PNIF) curves in follow-up of children in the treatment of allergic rhinitis. METHODS Prospective study of 40 patients with AR, grouped in corticosteroid spray versus physiological saline solution use. Follow up for 10 weeks through clinical score and PNIF percentages in relation to the reference curves, with was-out at week 8. Statistical assessment of the effect of treatment on variation of PNIF and clinical score was calculated by ANOVA model and Multiple Comparison of Means Test - Least Significant Difference. RESULTS There was a statistically significant influence of the group, time and interaction between time and group on PNIF percentages. Throughout follow up, patients from the treatment group had mean PNIF percentages significantly higher than the placebo group. Clinical score results also demonstrated a statistically significant influence between the groups, time and interaction between time and group. CONCLUSION Increase in PNIF percentage values observed in children treated with intranasal corticosteroids revealed the applicability of PNIF curves in their follow up.",2014,"Throughout follow up, patients from the treatment group had mean PNIF percentages significantly higher than the placebo group.","['allergic rhinitis', '40 patients with AR']","['intranasal corticosteroids', 'corticosteroid spray versus physiological saline solution use', 'placebo']","['PNIF curves', 'Peak Nasal Inspiratory Flow (PNIF) curves', 'variation of PNIF and clinical score', 'mean PNIF percentages']","[{'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",40.0,0.0199262,"Throughout follow up, patients from the treatment group had mean PNIF percentages significantly higher than the placebo group.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'de Souza Campos Fernandes', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ribeiro de Andrade', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'da Cunha Ibiapina', 'Affiliation': ''}]",Rhinology,['10.4193/Rhino13.158'] 1466,24778230,Field experiments of success-breeds-success dynamics.,"Seemingly similar individuals often experience drastically different success trajectories, with some repeatedly failing and others consistently succeeding. One explanation is preexisting variability along unobserved fitness dimensions that is revealed gradually through differential achievement. Alternatively, positive feedback operating on arbitrary initial advantages may increasingly set apart winners from losers, producing runaway inequality. To identify social feedback in human reward systems, we conducted randomized experiments by intervening in live social environments across the domains of funding, status, endorsement, and reputation. In each system we consistently found that early success bestowed upon arbitrarily selected recipients produced significant improvements in subsequent rates of success compared with the control group of nonrecipients. However, success exhibited decreasing marginal returns, with larger initial advantages failing to produce much further differentiation. These findings suggest a lesser degree of vulnerability of reward systems to incidental or fabricated advantages and a more modest role for cumulative advantage in the explanation of social inequality than previously thought.",2014,In each system we consistently found that early success bestowed upon arbitrarily selected recipients produced significant improvements in subsequent rates of success compared with the control group of nonrecipients.,['human reward systems'],[],['subsequent rates of success'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],[],,0.0329269,In each system we consistently found that early success bestowed upon arbitrarily selected recipients produced significant improvements in subsequent rates of success compared with the control group of nonrecipients.,"[{'ForeName': 'Arnout', 'Initials': 'A', 'LastName': 'van de Rijt', 'Affiliation': 'Departments of Sociology andInstitute for Advanced Computational Science, Stony Brook, NY 11794; arnout.vanderijt@stonybrook.edu.'}, {'ForeName': 'Soong Moon', 'Initials': 'SM', 'LastName': 'Kang', 'Affiliation': 'Department of Management Science and Innovation, University College London, London WC1E 6BT, United Kingdom; and.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Restivo', 'Affiliation': 'Department of Sociology, State University of New York, Geneseo, NY 14454.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Computer Science, State University of New York, Stony Brook, NY 11794;'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1316836111'] 1467,24075226,"A tale of two stimulants: mentholated cigarettes may play a role in cocaine, but not methamphetamine, dependence.","BACKGROUND Research suggests that mentholated cigarettes may play a role in cocaine dependence. The purpose of the present study was to expand upon the research on mentholated cigarettes and cocaine dependence and to evaluate the role of mentholated cigarettes in methamphetamine dependence. METHODS Secondary analysis of a multisite, randomized trial evaluating the impact of smoking-cessation treatment in stimulant-dependent outpatients (N=538). Participants' reasons for concurrent use of cigarettes and illicit stimulants were assessed via self-report. Stimulant-abstinence was measured by self-report and urine drug screens. Smoking cessation was assessed via self-report and carbon monoxide levels. RESULTS Of the 301 cocaine-dependent participants, 201 (67%) were menthol and 100 (33%) were non-menthol cigarette smokers. Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]). No parallel differences were found between menthol and non-menthol methamphetamine-dependent smokers. The prevalence of Caucasian menthol smokers was significantly greater in the cocaine-dependent participants (37.2%) than in the methamphetamine-dependent participants (17.61%), (X(2)(1)=14.4, p<.001, OR=2.77 [95% CI:1.62-4.73]). Smoking cessation was not significantly associated with cigarette type for either cocaine- or methamphetamine-dependent participants. CONCLUSIONS The present results suggest that mentholated cigarettes play a role in cocaine, but not methamphetamine, dependence.",2013,"Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]).","['Of the 301 cocaine-dependent participants, 201 (67%) were menthol and 100 (33%) were non-menthol cigarette smokers', 'stimulant-dependent outpatients (N=538']","['Cocaine', 'smoking-cessation treatment']","['Smoking cessation', 'prevalence of Caucasian menthol smokers']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",,0.0387282,"Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]).","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Cincinnati Addiction Research Treatment and Education Center (CinARTEC), Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gardin', 'Affiliation': ''}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Sonne', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Udi', 'Initials': 'U', 'LastName': 'Ghitza', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2013.09.002'] 1468,23815427,Relationship of age to impulsivity and decision making: a baseline secondary analysis of a behavioral treatment study in stimulant use disorders.,"Because stimulant use disorders remain prevalent across the lifespan, cognition is an important area of clinical care and research focus among aging adults with stimulant use disorders. This secondary analysis of a National Institute on Drug Abuse Clinical Trials Network study suggests that decision making, verbal learning/memory, executive function, and set shifting are important cognitive domains to screen clinically and treat in aging adults with stimulant use disorders. Some suggestions are made on how clinical treatment providers can practically use these results. An important direction for future research is the development of cognitively remediating treatments for impaired cognitive domains in aging adults with stimulant use disorders.",2013,An important direction for future research is the development of cognitively remediating treatments for impaired cognitive domains in aging adults with stimulant use disorders.,['aging adults with stimulant use disorders'],[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],[],,0.0209896,An important direction for future research is the development of cognitively remediating treatments for impaired cognitive domains in aging adults with stimulant use disorders.,"[{'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Kalapatapu', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA. kalapatapu.raj.k@gmail.com'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': ''}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Journal of addictive diseases,['10.1080/10550887.2013.795471'] 1469,32421612,Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.,"INTRODUCTION Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up. METHODS Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period. RESULTS Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms. LIMITATIONS As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors. CONCLUSION MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.",2020,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","['patients with recurrent or chronic depression', 'recurrent depression', 'recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up', 'Patients were recruited between July 2013 and December 2014 (N\xa0=\xa0122']","['MBCL', 'TAU', 'mindfulness-based compassionate living (MBCL', 'intervention', 'Mindfulness-Based Cognitive Therapy (MBCT', 'mindfulness-based compassionate living compared with treatment-as-usual']","['depressive symptoms', 'severity of depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0570495,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","[{'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Schuling', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: rhoda.schuling@radboudumc.nl.'}, {'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'van Ravesteijn', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.182'] 1470,32421444,"Neoadjuvant Chemotherapy in High-Risk Soft Tissue Sarcomas: Final Results of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG) Sarcoma Groups.","PURPOSE To determine whether the administration of histology-tailored neoadjuvant chemotherapy (HT) was superior to the administration of standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I) in high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall. PATIENTS AND METHODS This was a randomized, open-label, phase III trial. Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS). Patients were randomly assigned in a 1:1 ratio to receive three cycles of A+I or HT. The HT regimens were as follows: trabectedin in HG-MLPS; gemcitabine plus dacarbazine in LMS; high-dose prolonged-infusion ifosfamide in SS; etoposide plus ifosfamide in MPNST; and gemcitabine plus docetaxel in UPS. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors. The study is registered at ClinicalTrials.gov (identifier NCT01710176). RESULTS Between May 2011 and May 2016, 287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8%]) were randomly assigned to either A+I or HT. At the final analysis, with a median follow-up of 52 months, the projected DFS and OS probabilities were 0.55 and 0.47 (log-rank P = .323) and 0.76 and 0.66 (log-rank P = .018) at 60 months in the A+I arm and HT arm, respectively. No treatment-related deaths were observed. CONCLUSION In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.",2020,"In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.","['high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall', 'patients with high-risk STS', 'Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG', 'High-Risk Soft Tissue Sarcomas', 'Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS', '287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8']","['ifosfamide in SS; etoposide plus ifosfamide', 'histology-tailored neoadjuvant chemotherapy (HT', 'Neoadjuvant Chemotherapy', 'A+I or HT', 'gemcitabine plus docetaxel', 'standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I', 'gemcitabine plus dacarbazine']","['projected DFS and OS probabilities', 'disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0459558', 'cui_str': 'Body wall structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206634', 'cui_str': 'Myxoid liposarcoma'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0039101', 'cui_str': 'Synovial sarcoma'}, {'cui': 'C0751690', 'cui_str': 'Malignant peripheral nerve sheath tumor'}, {'cui': 'C0334463', 'cui_str': 'Fibrous histiocytoma, malignant'}, {'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0039101', 'cui_str': 'Synovial sarcoma'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.10756,"In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Palmerini', 'Affiliation': 'Chemotherapy Unit, IRCCS, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Quagliuolo', 'Affiliation': 'Department of Surgery, Istituto Clinico Humanitas, Rozzano, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martin Broto', 'Affiliation': 'Medical Oncology Department, University Hospital Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez Pousa', 'Affiliation': 'Department of Cancer Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Grignani', 'Affiliation': ""Department of Cancer Medicine, Fondazione del Piemonte per l'Oncologia, IRCCS, Candiolo, Turin, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Brunello', 'Affiliation': 'Department of Oncology, Medical Oncology 1 Unit, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Cancer Medicine, Centre Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Tendero', 'Affiliation': 'Department of Surgery, Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Diaz Beveridge', 'Affiliation': 'Department of Cancer Medicine, Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Department of Cancer Medicine, Istituto Regina Elena, Rome, Italy.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Lugowska', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Centrum Onkologii, Instytutim, Marii Sklodowskiej-Curie, Warszawa, Poland.'}, {'ForeName': 'Domenico Franco', 'Initials': 'DF', 'LastName': 'Merlo', 'Affiliation': 'Research and Statistics Infrastructure, Azienda Unità Sanitaria Locale, IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Fontana', 'Affiliation': 'Clinical Trial Center and Department of Epidemiology, IRCCS Azienda Ospedaliera Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Marchesi', 'Affiliation': 'Clinical Trial Center, Italian Sarcoma Group, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Braglia', 'Affiliation': 'Research and Statistics Infrastructure, Azienda Unità Sanitaria Locale, IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Davide Maria', 'Initials': 'DM', 'LastName': 'Donati', 'Affiliation': 'Department of Orthopedic Oncology, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Palassini', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bianchi', 'Affiliation': 'Department of Orthopedic Oncology, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marrari', 'Affiliation': 'Department of Cancer Medicine, Istituto Clinico Humanitas, Rozzano, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Morosi', 'Affiliation': 'Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Stacchiotti', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bagué', 'Affiliation': 'Department of Pathology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Coindre', 'Affiliation': 'Department of Pathology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Angelo Paolo', 'Initials': 'AP', 'LastName': 'Dei Tos', 'Affiliation': 'Department of Pathology, Treviso General Hospital Treviso, Padova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Picci', 'Affiliation': 'Laboratory of Oncologic Research, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'Clinical Trial Center and Department of Epidemiology, IRCCS Azienda Ospedaliera Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'Paolo Giovanni', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03289'] 1471,32421593,Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response.,"BACKGROUND Bipolar disorder is a heritable disorder, and we aimed to assess the impact of family history of mental disorders in first-degree relatives on the severity and course of bipolar disorder. METHODS The Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium) comparative effectiveness studies were similar trials among bipolar disorder outpatients studying four different randomized treatment arms for 24 weeks. Patients self-reported on six severe mental disorders among first-degree relatives. We performed ANOVA and linear regression regarding disease severity measures, sociodemographic and cardiometabolic markers and mixed effects linear regression to evaluate treatment response. RESULTS Among 757 patients, 644 (85.1%) reported at least one first-degree relative with a severe mental disorder (mean=2.8; standard deviation=2.2; range=0-13). Depression (67.1%), alcohol abuse (51.0%) and bipolar disorder (47.0%) were the most frequently reported disorders. Familial psychiatric history correlated with several disease severity measures (hospitalizations, suicide attempts, and earlier onset) and sociodemographic markers (lower education and household income) but not with cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score. Patients with familial psychiatric history tended to require more psychopharmacological treatment (p=0.054) but responded similarly (all p>0.1) to all four treatment arms. CONCLUSIONS Our findings indicate that familial psychiatric history is common among outpatients with bipolar disorder and correlates with disease severity and sociodemographic measures. Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.",2020,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"['Patients with familial psychiatric history', 'bipolar disorder outpatients', 'outpatients with bipolar disorder']",['Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium'],"['severe mental disorder', 'Depression', 'cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score', 'bipolar disorder', 'alcohol abuse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse'}]",757.0,0.044469,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark; Department of Clinical Medicin, Aarhus University, Aarhus, Denmark; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: karkoe@rm.dk.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Ruberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Fung', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital; Department of Medicine, Harvard Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Overhage', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH and Lindner Center of HOPE, Mason, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.157'] 1472,22908326,TNF blockers show distinct patterns of immune response to the pandemic influenza A H1N1 vaccine in inflammatory arthritis patients.,"OBJECTIVE To evaluate the immunogenicity of the anti-influenza A H1N1/2009 vaccine in RA and spondyloarthritis (SpA) patients receiving distinct classes of anti-TNF agents compared with patients receiving DMARDs and healthy controls. METHODS One hundred and twenty patients (RA, n = 41; AS, n = 57; PsA, n = 22) on anti-TNF agents (monoclonal, n = 94; soluble receptor, n = 26) were compared with 116 inflammatory arthritis patients under DMARDs and 117 healthy controls. Seroprotection, seroconversion (SC), geometric mean titre, factor increase in geometric mean titre and adverse events were evaluated 21 days after vaccination. RESULTS After immunization, SC rates (58.2% vs 74.3%, P = 0.017) were significantly lower in SpA patients receiving anti-TNF therapy, whereas no difference was observed in RA patients receiving this therapy compared with healthy controls (P = 0.067). SpA patients receiving mAbs (infliximab/adalimumab) had a significantly lower SC rate compared with healthy controls (51.6% vs 74.3%, P = 0.002) or those on DMARDs (51.6% vs 74.7%, P = 0.005), whereas no difference was observed for patients on etanercept (86.7% vs 74.3%, P = 0.091). Further analysis of non-seroconverting and seroconverting SpA patients revealed that the former group had a higher mean age (P = 0.003), a higher frequency of anti-TNF (P = 0.031) and mAbs (P = 0.001) and a lower frequency of MTX (P = 0.028). In multivariate logistic regression, only older age (P = 0.015) and mAb treatment (P = 0.023) remained significant factors for non-SC in SpA patients. CONCLUSION This study revealed a distinct disease pattern of immune response to the pandemic influenza vaccine in inflammatory arthritis patients receiving anti-TNF agents, illustrated by a reduced immunogenicity solely in SpA patients using mAbs. TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT01151644.",2012,"After immunization, SC rates (58.2% vs 74.3%, P = 0.017) were significantly lower in SpA patients receiving anti-TNF therapy, whereas no difference was observed in RA patients receiving this therapy compared with healthy controls (P = 0.067).","['inflammatory arthritis patients receiving anti-TNF agents, illustrated by a reduced immunogenicity solely in SpA patients using mAbs', 'inflammatory arthritis patients', 'RA and spondyloarthritis (SpA) patients receiving distinct classes of anti-TNF agents compared with patients receiving DMARDs and healthy controls', 'One hundred and twenty patients (RA, n = 41; AS, n = 57; PsA, n = 22) on anti-TNF agents (monoclonal, n = 94; soluble receptor, n = 26) were compared with 116 inflammatory arthritis patients under DMARDs and 117 healthy controls']","['SpA patients receiving mAbs (infliximab/adalimumab', 'TNF blockers', 'pandemic influenza vaccine']","['frequency of anti-TNF', 'Seroprotection, seroconversion (SC), geometric mean titre, factor increase in geometric mean titre and adverse events', 'SC rates', 'SC rate']","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",26.0,0.0338541,"After immunization, SC rates (58.2% vs 74.3%, P = 0.017) were significantly lower in SpA patients receiving anti-TNF therapy, whereas no difference was observed in RA patients receiving this therapy compared with healthy controls (P = 0.067).","[{'ForeName': 'Ivan Leonardo Avelino', 'Initials': 'IL', 'LastName': 'França', 'Affiliation': 'Disciplina de Reumatologia, Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Arnaldo, n° 455, 3° andar, sala 3190, Cerqueira César São Paulo, 05403-010, São Paulo, Brazil.'}, {'ForeName': 'Ana Cristina Medeiros', 'Initials': 'AC', 'LastName': 'Ribeiro', 'Affiliation': ''}, {'ForeName': 'Nádia Emi', 'Initials': 'NE', 'LastName': 'Aikawa', 'Affiliation': ''}, {'ForeName': 'Carla Gonçalves Schain', 'Initials': 'CG', 'LastName': 'Saad', 'Affiliation': ''}, {'ForeName': 'Julio Cesar Bertacine', 'Initials': 'JC', 'LastName': 'Moraes', 'Affiliation': ''}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Goldstein-Schainberg', 'Affiliation': ''}, {'ForeName': 'Ieda Maria Magalhães', 'Initials': 'IM', 'LastName': 'Laurindo', 'Affiliation': ''}, {'ForeName': 'Alexander Roberto', 'Initials': 'AR', 'LastName': 'Precioso', 'Affiliation': ''}, {'ForeName': 'Maria Akiko', 'Initials': 'MA', 'LastName': 'Ishida', 'Affiliation': ''}, {'ForeName': 'Ana Marli Christovam', 'Initials': 'AM', 'LastName': 'Sartori', 'Affiliation': ''}, {'ForeName': 'Clovis Artur', 'Initials': 'CA', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Bonfa', 'Affiliation': ''}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kes202'] 1473,32036492,Randomized phase II/III study of 5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel administered to patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G).,"BACKGROUND Oral fluoropyrimidine plus cisplatin is often not tolerated by patients with severe peritoneal metastases of gastric cancer. Combination of 5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX) has promising activity for such patients. We conducted a phase II/III study comparing FLTAX with 5-FU/l-LV. METHODS Eligibility criteria included: unresectable or recurrent gastric adenocarcinoma; 20-75 years; performance status (PS) 0-2; peritoneal metastases + ; massive ascites and/or inadequate oral intake; no prior chemotherapy. Patients were randomly assigned to receive 5-FU/l-LV or FLTAX. The primary endpoint of phase III was overall survival: UMIN000010949. RESULTS We enrolled 101 patients. Early deaths occurred in patients with PS 2 having massive ascites and inadequate oral intake simultaneously; the protocol was amended to exclude such patients. Median survival times were 6.1 and 7.3 months for the 5-FU/l-LV and the FLTAX arms, respectively (HR 0.792; 80% CI 0.596-1.053; one-sided p = 0.1445). FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)]. Grade 3/4 adverse events such as leucopenia and anorexia were more frequently observed in the 5-FU/l-LV arm. In the 5-FU/l-LV arm, two deaths were treatment-related. In the 5-FU/l-LV and FLTAX arms, 12 and 3 deaths occurred within 30 days after the last protocol treatment, respectively. CONCLUSIONS Chemotherapy was indicated for patients with severe peritoneal metastases excluding patients with PS 2 having massive ascites and inadequate oral intake simultaneously. FLTAX did not confer a significant survival benefit but may be preferred because of longer PFS and acceptable toxicity.",2020,"FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)].","['We enrolled 101 patients', 'patients with severe peritoneal metastases of gastric cancer', 'patients with severe peritoneal metastases excluding patients with PS 2 having massive ascites and inadequate oral intake simultaneously', 'patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G', 'Eligibility criteria included: unresectable or recurrent gastric adenocarcinoma; 20-75\xa0years; performance status (PS) 0-2; peritoneal metastases\u2009+\u2009; massive ascites and/or inadequate oral intake; no prior chemotherapy']","['FLTAX with 5-FU/l-LV', 'FLTAX', '5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel', '5-FU/l-LV or FLTAX', '5-FU/l-LV and FLTAX', '5-FU/l-LV', 'fluoropyrimidine plus cisplatin', '5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX']","['Early deaths', 'Median survival times', 'Grade 3/4 adverse events such as leucopenia and anorexia', 'longer progression-free survival (PFS', 'overall survival: UMIN000010949']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C3714435', 'cui_str': 'Inadequate oral intake (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",101.0,0.0523077,"FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)].","[{'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. tnakajima@marianna-u.ac.jp.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Department of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'West Japan Oncology Group (WJOG) Data Center Division, Yokohama, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01043-x'] 1474,22209655,Injection behaviors among injection drug users in treatment: the role of hepatitis C awareness.,"BACKGROUND Injection drug use (IDU) is a primary vector for blood-borne infections. Awareness of Hepatitis C virus (HCV) infection status may affect risky injection behaviors. This study determines the prevalence of risky injection practices and examines associations between awareness of positive HCV status and risky injection behaviors. METHODS We surveyed individuals seeking treatment for substance use at 12 community treatment programs as part of a national HIV screening trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Participants reported socio-demographic characteristics, substance use, risk behaviors, and HCV status. We used multivariable logistic regression to test associations between participant characteristics and syringe/needle sharing. RESULTS The 1281 participants included 244 (19.0%) individuals who reported injecting drugs in the past 6 months and 37.7% of IDUs reported being HCV positive. During the six months preceding baseline assessment, the majority of IDUs reported obtaining sterile syringes from pharmacies (51.6%) or syringe exchange programs (25.0%), but fewer than half of IDUs always used a sterile syringe (46.9%). More than one-third (38.5%) shared syringe/needles with another injector in the past 6 months. Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis. CONCLUSIONS Risky injection behaviors remain prevalent and awareness of HCV infection was associated with increased risky injection behaviors. New approaches are needed to broadly implement HCV prevention interventions for IDUs seeking addiction treatment.",2012,"Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis. ","['We surveyed individuals seeking treatment for substance use at 12 community treatment programs as part of a national HIV screening trial conducted within the National Drug Abuse Treatment Clinical Trials Network', '1281 participants included 244 (19.0%) individuals who reported injecting drugs in the past 6 months and 37.7% of IDUs reported being HCV positive']",[],"['risky injection behaviors', 'Injection behaviors', 'socio-demographic characteristics, substance use, risk behaviors, and HCV status']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",[],"[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",1281.0,0.065065,"Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis. ","[{'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Department of Medicine and Department of Public Health and Preventive Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. korthuis@ohsu.edu'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': ''}, {'ForeName': 'Zoilyn L', 'Initials': 'ZL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Moupali', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tross', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ''}, {'ForeName': 'Raul N', 'Initials': 'RN', 'LastName': 'Mandler', 'Affiliation': ''}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Sorensen', 'Affiliation': ''}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Colfax', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McCarty', 'Affiliation': ''}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Penn', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Lape', 'Affiliation': ''}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': ''}]",Addictive behaviors,['10.1016/j.addbeh.2011.12.001'] 1475,22073385,"Treatment of depression associated with age-related macular degeneration: a double-blind, randomized, controlled study.","BACKGROUND Depression is frequently found in patients with age-related macular degeneration (AMD). The purpose of this study was to assess the effectiveness of escitalopram in treating major and minor depression in AMD patients. METHODS We conducted a crossover, randomized, double-blind, placebo-controlled, 16-week study comparing escitalopram with placebo. Inclusion criteria included reduced vision from AMD and major or minor depression, with a 17-item Hamilton Rating Scale for Depression (HAMD-17) score of ≥10. Participants were randomly assigned to receive either escitalopram or placebo for 8 weeks and then crossed over to the other treatment. The primary outcome was change on the total HAMD-17 score with escitalopram treatment compared with placebo. RESULTS We enrolled 16 AMD patients (mean age 79.1), 12 with major depression and 4 with minor depression. Mean HAMD-17 score at enrollment was 16.1 ± 4.2, and mean visual acuity in the better eye was 20/70. During escitalopram treatment, participants showed a significant reduction in HAMD-17 scores compared with placebo treatment (P = .01). CONCLUSIONS These findings suggest escitalopram may be an effective treatment for depressive symptoms associated with major or minor depression in AMD patients with vision loss.",2011,"During escitalopram treatment, participants showed a significant reduction in HAMD-17 scores compared with placebo treatment (P = .01). ","['patients with age-related macular degeneration (AMD', 'AMD patients with vision loss', 'AMD patients', '16 AMD patients (mean age 79.1), 12 with major depression and 4 with minor depression', 'depression associated with age-related macular degeneration']","['escitalopram or placebo', 'escitalopram', 'placebo']","['reduced vision from AMD and major or minor depression, with a 17-item Hamilton Rating Scale for Depression (HAMD-17) score of ≥10', 'mean visual acuity', 'HAMD-17 scores', 'total HAMD-17 score', 'Mean HAMD-17 score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042798', 'cui_str': 'Vision, Diminished'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",16.0,0.635951,"During escitalopram treatment, participants showed a significant reduction in HAMD-17 scores compared with placebo treatment (P = .01). ","[{'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Brody', 'Affiliation': 'Department of Ophthalmology, Division of Biostatistics, University of California, San Diego, La Jolla, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Field', 'Affiliation': ''}, {'ForeName': 'Anne-Catherine', 'Initials': 'AC', 'LastName': 'Roch-Levecq', 'Affiliation': ''}, {'ForeName': 'Christine Y', 'Initials': 'CY', 'LastName': 'Moutier', 'Affiliation': ''}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Edland', 'Affiliation': ''}, {'ForeName': 'Stuart I', 'Initials': 'SI', 'LastName': 'Brown', 'Affiliation': ''}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[] 1476,22085803,Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.,"Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.",2012,Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments.,['500 participants enrolled in 10 outpatient substance abuse treatment programs'],['computer-assisted intervention'],['effectiveness and cost-effectiveness'],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",500.0,0.0825457,Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments.,"[{'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': 'New York State Psychiatric Institute, Department of Psychiatry, Columbia University College of Physicians and Surgeons, 1051 Riverside Drive, New York, NY 10032, United States. anc2002@columbia.edu'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Gloria M', 'Initials': 'GM', 'LastName': 'Miele', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Udi E', 'Initials': 'UE', 'LastName': 'Ghitza', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Turrigiano', 'Affiliation': ''}, {'ForeName': 'Genie L', 'Initials': 'GL', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'VanVeldhuisen', 'Affiliation': ''}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Chapdelaine', 'Affiliation': ''}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Froias', 'Affiliation': ''}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Clingerman', 'Affiliation': ''}, {'ForeName': 'Livangelie', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': ''}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McClure', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': ''}, {'ForeName': 'A Rebecca', 'Initials': 'AR', 'LastName': 'Crowell', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2011.11.001'] 1477,25179753,Brief intervention for patients with problematic drug use presenting in emergency departments: a randomized clinical trial.,"IMPORTANCE Medical treatment settings such as emergency departments (EDs) present important opportunities to address problematic substance use. Currently, EDs do not typically intervene beyond acute medical stabilization. OBJECTIVE To contrast the effects of a brief intervention with telephone boosters (BI-B) with those of screening, assessment, and referral to treatment (SAR) and minimal screening only (MSO) among drug-using ED patients. DESIGN, SETTING, AND PARTICIPANTS Between October 2010 and February 2012, 1285 adult ED patients from 6 US academic hospitals, who scored 3 or greater on the 10-item Drug Abuse Screening Test (indicating moderate to severe problems related to drug use) and who were currently using drugs, were randomized to MSO (n = 431), SAR (n = 427), or BI-B (n = 427). Follow-up assessments were conducted at 3, 6, and 12 months by blinded interviewers. INTERVENTIONS Following screening, MSO participants received only an informational pamphlet. The SAR participants received assessment plus referral to addiction treatment if indicated, and the BI-B participants received assessment and referral as in SAR, plus a manual-guided counseling session based on motivational interviewing principles and up to 2 ""booster"" sessions by telephone during the month following the ED visit. MAIN OUTCOMES AND MEASURES Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug, days using any drug, days of heavy drinking, and drug use based on analysis of hair samples. The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up. RESULTS Follow-up rates were 89%, 86%, and 81% at 3, 6, and 12 months, respectively. For the primary outcome, estimated differences in number of days of use (95% CI) were as follows: MSO vs BI-B, 0.72 (-0.80 to 2.24), P (adjusted) = .57; SAR vs BI-B, 0.70 (-0.83 to 2.23), P (adjusted) = .57; SAR vs MSO, -0.02 (-1.53 to 1.50), P (adjusted) = .98. There were no significant differences between groups in self-reported days using the primary drug, days using any drug, or heavy drinking days at 3, 6, or 12 months. At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280 [95%]) than did participants in the MSO group (253 of 287 [88%]) or the BI-B group (244 of 275 [89%]). Hair analysis differences between groups at other time points were not significant. CONCLUSIONS AND RELEVANCE In this sample of drug users seeking emergency medical treatment, a relatively robust brief intervention did not improve substance use outcomes. More work is needed to determine how drug use disorders may be addressed effectively in the ED. TRIAL REGISTRATION clinicaltrials.gov Identifier:NCT01207791.",2014,"At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280 [95%]) than did participants in the MSO group (253 of 287 [88%]) or the BI-B group (244 of 275 [89%]).","['Between October 2010 and February 2012, 1285 adult ED patients from 6 US academic hospitals, who scored 3 or greater on the 10-item Drug Abuse Screening Test (indicating moderate to severe problems related to drug use) and who were currently using drugs', 'patients with problematic drug use presenting in emergency departments']","['Brief intervention', 'telephone boosters (BI-B) with those of screening, assessment, and referral to treatment (SAR) and minimal screening only (MSO', 'MSO']","['number of days of use', 'self-reported days using the patient-defined primary problem drug, days using any drug, days of heavy drinking, and drug use based on analysis of hair samples', 'self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up', 'rate of hair samples positive']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0451130', 'cui_str': 'Drug abuse screening test (assessment scale)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444095', 'cui_str': 'Hair specimen (specimen)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",1285.0,0.12509,"At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280 [95%]) than did participants in the MSO group (253 of 287 [88%]) or the BI-B group (244 of 275 [89%]).","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bogenschutz', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Sciences Center, Albuquerque2Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Alcohol & Drug Abuse Institute, University of Washington, Seattle4Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Raul N', 'Initials': 'RN', 'LastName': 'Mandler', 'Affiliation': 'National Institute on Drug Abuse, Bethesda, Maryland.'}, {'ForeName': 'Harold I', 'Initials': 'HI', 'LastName': 'Perl', 'Affiliation': 'National Institute on Drug Abuse, Bethesda, Maryland.'}, {'ForeName': 'Alyssa A', 'Initials': 'AA', 'LastName': 'Forcehimes', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Sciences Center, Albuquerque2Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Crandall', 'Affiliation': 'Department of Emergency Medicine, University of New Mexico Health Sciences Center, Albuquerque.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Oden', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Metsch', 'Affiliation': 'Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McCormack', 'Affiliation': 'Department of Emergency Medicine, New York University School of Medicine, New York.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Macias-Konstantopoulos', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston12Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA internal medicine,['10.1001/jamainternmed.2014.4052'] 1478,22613054,Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world.,"Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60 mg/day) for cocaine-relapse prevention. The study includes pilot (N=60) and full-scale (estimated N=264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention.",2012,All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS).,"['participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge', 'National Institute on Drug Abuse (NIDA', 'adults with cocaine dependence']","['buspirone', 'placebo']","['UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance', 'maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1513899', 'cui_str': 'NIDA (US)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}]","[{'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",,0.0762513,All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS).,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH 45220, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Stitzer', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Woody', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': ''}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Sparenborg', 'Affiliation': ''}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vanveldhuisen', 'Affiliation': ''}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Somoza', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2012.05.003'] 1479,32423706,The prognostic value of voiding chart data in therapy-resistant enuresis.,"INTRODUCTION The case history is the primary tool when investigating the enuretic child. To further determine whether nocturnal polyuria or detrusor overactivity is present, a full voiding chart, is the method of choice. However, there is no robust evidence that daytime voiding chart data actually do predict nocturnal detrusor function. AIM The aim of this study was to assess the predictive value of anamnestic data and the voiding chart in the treatment of children with therapy-resistant enuresis. PATIENTS AND METHODS The patients all suffered from enuresis resistant to first-line therapy. None of the children had daytime incontinence. In accordance with international recommendations, the children were first treated with anticholinergics. If the therapeutic effect was not satisfactory dosage was adjusted and desmopressin was added. If sufficient treatment effect was not achieved, antidepressant therapy was tried next, combined with desmopressin if needed. Since this was an evaluation of clinical practice, not a randomized trial, treatment success was graded according to family satisfaction, not the actual frequency of wet nights. Thus, only children who reported that they were completely dry were regarded as full responders and those who stated that there was a substantial and useful reduction of wet nights were labeled intermediate responders. RESULTS In total, 154 patients were included. Few and inconsistent differences were found between the groups responding or not responding to the various treatment regimens, and this was true both for anamnestic and voiding chart data (see Table). The only statistically significant findings were that responders to antidepressant therapy were older (p = 0.013) than non-responders, and patients who benefited from addition of desmopressin had a higher micturition frequency than those who did not (p = 0.027). The children who needed desmopressin as part of combination treatment to become dry did not have significantly higher nocturnal urine production than those who had no such benefit (p = 0.619). Neither the presence of urgency nor a history of previous daytime incontinence was significantly more common in children responding to anticholinergics (p = 0.375 and 0.072, respectively). DISCUSSION No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens. Not even urgency could predict anticholinergic efficacy. Somewhat surprisingly, no association between nocturnal polyuria and desmopressin benefit was found. CONCLUSION In this study no prognostic value was found in anamnestic or voiding chart data in children with therapy resistant enuresis.",2020,No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens.,"['children with therapy resistant enuresis', '154 patients were included', 'children with therapy-resistant enuresis']","['anticholinergics', 'desmopressin']","['daytime incontinence', 'nocturnal polyuria and desmopressin benefit', 'presence of urgency nor a history of previous daytime incontinence', 'micturition frequency', 'nocturnal urine production', 'anticholinergic efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0848232', 'cui_str': 'Nocturnal polyuria'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",154.0,0.0265485,No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens.,"[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Lundmark', 'Affiliation': 'Dept. of Women´s and Children´s Health, Uppsala University, Akademiska Barnsjukhuset, SE-751 85 Uppsala, Sweden. Electronic address: elisabet.lundmark@kbh.uu.se.'}, {'ForeName': 'Tryggve', 'Initials': 'T', 'LastName': 'Neve Us', 'Affiliation': 'Dept. of Women´s and Children´s Health, Uppsala University, Akademiska Barnsjukhuset, SE-751 85 Uppsala, Sweden.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.02.020'] 1480,32423734,"Right Ventricular Systolic Assessment by Transesophageal Versus Transthoracic Echocardiography: Displacement, Velocity, and Myocardial Deformation.","OBJECTIVE First, to compare tricuspid annular displacement and velocity in transthoracic and transesophageal echocardiography (TTE, TEE) using conventional angle-dependent technologies. Second, to evaluate both alternative TEE views as well as an alternative technology (speckle tracking) for overcoming proposed differences in TTE and TEE. DESIGN Prospective, comparative, cross-over study with a randomized order of image acquisition. SETTING University hospital. PARTICIPANTS Adults undergoing cardiac surgery. INTERVENTIONS Postinduction standardized image acquisition and analysis in TTE and TEE by 2 echocardiographers. MEASUREMENTS AND MAIN RESULTS The authors measured tricuspid annular plane systolic excursion (TAPSE) by M-mode and velocity by tissue Doppler (S') in the apical 4-chamber TTE view and midesophageal 4-chamber TEE view (AP4C, ME4C). They then examined (1) the same measurements in alternative TEE views with proposed better ultrasound angulation; and (2) speckle tracking-based endpoints (TAPSE by speckle tracking, strain, and strain rate). Data were available in 24 of 25 patients. Conventional TAPSE by M-mode and velocity by tissue Doppler (TDI) were underestimated in the ME4C compared with the AP4C reference (mean ± standard deviation: TAPSE: 13.1 ± 3.8 mm v 17.3 ± 4.0 mm; S': 6.7 ± 2.1 cm/s v 9.1 ± 2.2 cm/s; both p < 0.001). Neither a modified deep transgastric view (TAPSE 14.5 ± 4.7 mm, p = 0.017; S' 6.8 ± 1.8 cm/s, p < 0.001) nor a transgastric right ventricular inflow view (TAPSE 12.3 ± 4.0 mm, p = 0.001; S' 6.0 ± 1.3 cm/s, p < 0.001) was similar to the AP4C. Speckle tracking TAPSE was unbiased but with high variability (mean bias = -0.3 mm, 95% limits of agreement = -9.1 to 8.4); strain and strain rate were higher in TEE than for TTE (-17.7 ± 3.6 v -12.6 ± 2.1, p < 0.001; -1.0 ± 0.2/s v -0.7 ± 0.1/s, p < 0.001). CONCLUSIONS Right ventricular displacement, velocity, and myocardial deformation measured by TEE versus TTE are different. Neither alternative transesophageal echocardiography views nor speckle tracking-based deformation is promising; TAPSE by speckle tracking is unbiased but imprecise.",2020,"Neither a modified deep transgastric view (TAPSE 14.5 ± 4.7 mm, p = 0.017; S' 6.8 ± 1.8 cm/s, p < 0.001) nor a transgastric right ventricular inflow view (TAPSE 12.3 ± 4.0 mm, p = 0.001; S' 6.0 ± 1.3 cm/s, p < 0.001) was similar to the AP4C. Speckle tracking TAPSE was unbiased but with high variability (mean bias = -0.3 mm, 95% limits of agreement = -9.1 to 8.4); strain and strain rate were higher in TEE than for TTE (-17.7 ± 3.6 v -12.6 ± 2.1, p < 0.001; -1.0 ± 0.2/s v -0.7 ± 0.1/s, p < 0.001). ","['University hospital', 'Adults undergoing cardiac surgery']","['transthoracic and transesophageal echocardiography (TTE, TEE']","[""tricuspid annular plane systolic excursion (TAPSE) by M-mode and velocity by tissue Doppler (S') in the apical 4-chamber TTE view and midesophageal 4-chamber TEE view (AP4C, ME4C"", 'Right ventricular displacement, velocity, and myocardial deformation', 'Conventional TAPSE by M-mode and velocity by tissue Doppler (TDI', 'strain and strain rate', 'transgastric right ventricular inflow view']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]","[{'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0631478', 'cui_str': ""adenosine 5' P(1)-tetraphosphate-P(4)-5'''-cytidine""}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0442355', 'cui_str': 'Transgastric'}]",,0.044055,"Neither a modified deep transgastric view (TAPSE 14.5 ± 4.7 mm, p = 0.017; S' 6.8 ± 1.8 cm/s, p < 0.001) nor a transgastric right ventricular inflow view (TAPSE 12.3 ± 4.0 mm, p = 0.001; S' 6.0 ± 1.3 cm/s, p < 0.001) was similar to the AP4C. Speckle tracking TAPSE was unbiased but with high variability (mean bias = -0.3 mm, 95% limits of agreement = -9.1 to 8.4); strain and strain rate were higher in TEE than for TTE (-17.7 ± 3.6 v -12.6 ± 2.1, p < 0.001; -1.0 ± 0.2/s v -0.7 ± 0.1/s, p < 0.001). ","[{'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Mauermann', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium; Department of Anesthesiology, University Hospital Basel, Basel, Switzerland. Electronic address: Eckhard.Mauermann@usb.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vandenheuvel', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'François', 'Affiliation': 'Department of Cardiac Surgery, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Bouchez', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wouters', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.009'] 1481,25179587,"Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.","Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders.",2014,NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group.,"['cannabis cessation in adults (ages 18-50', 'Approximately 300 treatment-seeking cannabis-dependent adults']","['placebo', 'N-acetylcysteine (NAC) versus placebo (PBO', 'NAC', 'NAC combined with a behavioral intervention', 'twice-daily orally-administered NAC', 'cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT']",[],"[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0947697', 'cui_str': 'Accent'}]",[],,0.133498,NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group.,"[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States. Electronic address: mccluree@musc.edu.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Sonne', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, 950 Campbell Ave, West Haven, CT 06516, United States.'}, {'ForeName': 'Udi E', 'Initials': 'UE', 'LastName': 'Ghitza', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Boulevard, MSC 9557, Bethesda, MD 20892, United States.'}, {'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McRae-Clark', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Veldhuisen', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Vandrey', 'Affiliation': 'Johns Hopkins University, School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Columbia University/New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, United States.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, 115 Mill St., Belmont, MA 02478, United States; Department of Psychiatry, Harvard Medical School, 25 Shattuck St., Boston, MA 02115, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Mooney', 'Affiliation': 'University of California, Los Angeles, David Geffen School of Medicine, 1640 S. Sepulveda Blvd., Suite 120, Los Angeles, CA 90025, United States.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Haynes', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, United States.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Sparenborg', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Boulevard, MSC 9557, Bethesda, MD 20892, United States.'}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Hasson', 'Affiliation': 'University of California, Los Angeles, David Geffen School of Medicine, 1640 S. Sepulveda Blvd., Suite 120, Los Angeles, CA 90025, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2014.08.011'] 1482,24345356,A randomized trial of concurrent smoking-cessation and substance use disorder treatment in stimulant-dependent smokers.,"OBJECTIVE To evaluate the impact of concurrent treatments for substance use disorder and nicotine-dependence for stimulant-dependent patients. METHOD A randomized, 10-week trial with follow-up at 3 and 6 months after smoking quit date conducted at 12 substance use disorder treatment programs between February 2010 and July 2012. Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking were randomized to treatment as usual (n = 271) or treatment as usual with smoking-cessation treatment (n = 267). All participants received treatment as usual for substance use disorder treatment. Participants assigned to treatment as usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion (300 mg/d) during weeks 1-10. During post-quit treatment (weeks 4-10), participants assigned to treatment as usual with smoking-cessation treatment received a nicotine inhaler and contingency management for smoking abstinence. Weekly proportion of stimulant-abstinent participants during the treatment phase, as assessed by urine drug screens and self-report, was the primary outcome. Secondary measures included other substance/nicotine use outcomes and treatment attendance. RESULTS There were no significant treatment effects on stimulant-use outcomes, as measured by the primary outcome and stimulant-free days, on drug-abstinence, or on attendance. Participants assigned to treatment as usual with smoking-cessation treatment, relative to those assigned to treatment as usual, had significantly better outcomes for drug-free days at 6-month follow-up (χ(2)(1) = 4.09, P <.05), with a decrease in drug-free days from baseline of -1.3% in treatment as usual with smoking-cessation treatment and of -7.6% in treatment as usual. Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001; OR =18.2). CONCLUSIONS These results suggest that providing smoking-cessation treatment to illicit stimulant-dependent patients in outpatient substance use disorder treatment will not worsen, and may enhance, abstinence from nonnicotine substance use. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01077024.",2014,"Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001;","['stimulant-dependent smokers', 'Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking', 'stimulant-dependent patients', '12 substance use disorder treatment programs between February 2010 and July 2012']","['nicotine inhaler and contingency management for smoking abstinence', 'usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion', 'concurrent smoking-cessation and substance use disorder treatment', 'usual with smoking-cessation treatment']","['stimulant-free days, on drug-abstinence, or on attendance', 'smoking point-prevalence abstinence', 'substance/nicotine use outcomes and treatment attendance']","[{'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0814019', 'cui_str': 'Nicotine inhaler'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0628819,"Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001;","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'University of Cincinnati, 3210 Jefferson Ave, Cincinnati, OH 45220 winhusen@carc.uc.edu.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gardin', 'Affiliation': ''}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Penn', 'Affiliation': ''}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Hodgkins', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCann', 'Affiliation': ''}, {'ForeName': 'Lee D', 'Initials': 'LD', 'LastName': 'Love', 'Affiliation': ''}, {'ForeName': 'Eliot', 'Initials': 'E', 'LastName': 'DeGravelles', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Bachrach', 'Affiliation': ''}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Sonne', 'Affiliation': ''}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Hiott', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'VanVeldhuisen', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Udi', 'Initials': 'U', 'LastName': 'Ghitza', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.13m08449'] 1483,32078486,Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial.,"Background and Purpose- While combination aspirin and clopidogrel reduces recurrent stroke compared with aspirin alone in patients with transient ischemic attack (TIA) or minor stroke, the effect on disability is uncertain. Methods- The POINT trial (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) randomized patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel versus aspirin alone. The primary outcome measure was a composite of stroke, myocardial infarction, or vascular death. We performed a post hoc exploratory analysis to examine the effect of treatment on overall disability (defined as modified Rankin Scale score >1) at 90 days, as well as disability ascribed by the local investigator to index or recurrent stroke. We also evaluated predictors of disability. Results- At 90 days, 188 of 1964 (9.6%) of patients enrolled with TIA and 471 of 2586 (18.2%) of those enrolled with stroke were disabled. Overall disability was similar between patients assigned DAPT versus aspirin alone (14.7% versus 14.3%; odds ratio, 0.97 [95% CI, 0.82-1.14]; P =0.69). However, there were numerically fewer patients with disability in conjunction with a primary outcome event in the DAPT arm (3.0% versus 4.0%; odds ratio, 0.73 [95% CI, 0.53-1.01]; P =0.06) and significantly fewer patients in the DAPT arm with disability attributed by the investigators to either the index event or recurrent stroke (5.9% versus 7.4%; odds ratio, 0.78 [95% CI, 0.62-0.99]; P =0.04). Notably, disability attributed to the index event accounted for the majority of this difference (4.5% versus 6.0%; odds ratio, 0.74 [95% CI, 0.57-0.96]; P =0.02). In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability. Conclusions- In addition to reducing recurrent stroke in patients with acute minor stroke and TIA, DAPT might reduce stroke-related disability. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00991029.",2020,"In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability.","['patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with', 'patients with transient ischemic attack (TIA) or minor stroke']","['DAPT', 'aspirin', 'aspirin and clopidogrel', 'Methods', ' and Purpose', 'aspirin plus clopidogrel versus aspirin alone', 'Conclusions']","['overall disability', 'index event or recurrent stroke', 'female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events', 'composite of stroke, myocardial infarction, or vascular death', 'Overall disability', 'recurrent stroke', 'ischemic stroke, serious adverse events, and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0348593', 'cui_str': 'Subsequent myocardial infarction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.144752,"In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability.","[{'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Cucchiara', 'Affiliation': 'From the Department of Neurology, University of Pennsylvania, Philadelphia (B.C.).'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neurosciences, Radiology and Community Health Sciences, University of Calgary, Hotchkiss Brain Institute, AB, Canada (S.B.C.).'}, {'ForeName': 'Joshua Z', 'Initials': 'JZ', 'LastName': 'Willey', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY (J.Z.W.).'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Biros', 'Affiliation': 'Emergency Medicine, University of Minnesota, Minneapolis (M.H.B.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Ross', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA (M.A.R.).'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Emergency Medicine Dean's Office, Dell Medical School, University of Texas-Austin (S.C.J.).""}]",Stroke,['10.1161/STROKEAHA.119.027465'] 1484,22771145,Frontal systems deficits in stimulant-dependent patients: evidence of pre-illness dysfunction and relationship to treatment response.,"BACKGROUND Frontal systems dysfunction is present in stimulant-dependent patients. However, it is unclear whether this dysfunction is a pre-morbid risk factor or stimulant-induced, is severe enough to be clinically relevant, and if it is relevant to treatment response. These questions were addressed using the Frontal Systems Behavior Scale (FrSBe), a reliable and valid self-report assessment of three neurobehavioral domains associated with frontal systems functioning (Apathy, Disinhibition, and Executive Dysfunction, summed for a Total), that assesses both pre- and post-morbid functioning, and has a specific cutoff for defining clinically significant abnormalities. METHOD Six sites evaluating 12-step facilitation for stimulant abusers obtained the FrSBe from 180 methamphetamine- and/or cocaine-dependent participants. Dichotomous treatment response measures included self-reported stimulant use, stimulant urine drug screens, and treatment completion. RESULTS A substantial percentage of participants retrospectively reported clinically significant neurobehavioral abnormalities prior to lifetime stimulant abuse initiation (e.g., 67.5% on FrSBe-Total) with a significant increase in the proportion reporting such abnormalities for current functioning (86% on FrSBe-Total; p<0.0001). Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40). CONCLUSION These findings suggest that frontal systems dysfunction is present prior to stimulant-abuse onset and worsens with stimulant use. Disinhibition may be a prime target for intervention in stimulant-dependent individuals.",2013,"Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40). ",['Six sites evaluating 12-step facilitation for stimulant abusers obtained the FrSBe from 180 methamphetamine- and/or cocaine-dependent participants'],[],"['Frontal Systems Behavior Scale (FrSBe', 'self-reported stimulant use, stimulant urine drug screens, and treatment completion']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",[],"[{'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.04162,"Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40). ","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Eugene C', 'Initials': 'EC', 'LastName': 'Somoza', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Frankie B', 'Initials': 'FB', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Viviana Elizabeth', 'Initials': 'VE', 'LastName': 'Horigian', 'Affiliation': ''}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2012.06.017'] 1485,31399440,Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials.,"OBJECTIVE The impact of major affective disorders on the effectiveness of diabetes prevention programs at promoting health behaviors has not been established. We investigated whether depression modifies the effectiveness of two pragmatic diabetes prevention programs at promoting increased physical activity. RESEARCH DESIGN AND METHODS This study pooled data from two cluster randomized controlled trials (Walking Away from Type 2 Diabetes and Let's Prevent Type 2 Diabetes) that included individuals at high risk of type 2 diabetes who were recruited from primary care. The trials used very similar intervention methods to promote physical activity and had annual follow-up over a 36-month period. Depressive symptoms were measured by the Hospital Anxiety and Depression Scale, and physical activity was measured by a piezoelectric pedometer (Let's Prevent Type 2 Diabetes) or an accelerometer (Walking Away from Type 2 Diabetes) and expressed as steps per day. RESULTS This analysis included 1,163 individuals (571 control, 592 intervention) who had concurrent baseline and follow-up data for ambulatory activity, depression, and anxiety. The median depression score was 3 at baseline; 11% of individuals were classified as having mild to severe depression. Those with no depressive symptoms at baseline or during follow-up increased their ambulatory activity by 592 steps per day ( P < 0.001); this effect decayed by 88 steps per day (95% CI 21, 155) for every additional depressive symptom score at baseline, and each increase in the depressive symptom score between baseline and follow-up further attenuated the intervention effect by 99 steps per day (95% CI 2, 196). CONCLUSIONS Both depressive symptom burden at baseline and change in this burden are associated with a graded reduction in the effectiveness of diabetes prevention programs at increasing physical activity in primary care.",2019,Both depressive symptom burden at baseline and change in this burden are associated with a graded reduction in the effectiveness of diabetes prevention programs at increasing physical activity in primary care.,"['1,163 individuals (571 control, 592 intervention) who had concurrent baseline and follow-up data for ambulatory activity, depression, and anxiety', 'Primary Care', ""Type 2 Diabetes and Let's Prevent Type 2 Diabetes) that included individuals at high risk of type 2 diabetes who were recruited from primary care""]","['piezoelectric pedometer ', 'diabetes prevention programs']","['Depressive symptoms', 'ambulatory activity', 'depressive symptom score', 'median depression score', 'Hospital Anxiety and Depression Scale, and physical activity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",1163.0,0.137956,Both depressive symptom burden at baseline and change in this burden are associated with a graded reduction in the effectiveness of diabetes prevention programs at increasing physical activity in primary care.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K. ty20@le.ac.uk.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}]",Diabetes care,['10.2337/dc19-0400'] 1486,31399442,Effect of Linagliptin on Cognitive Performance in Patients With Type 2 Diabetes and Cardiorenal Comorbidities: The CARMELINA Randomized Trial.,"OBJECTIVE Type 2 diabetes is associated with cognitive dysfunction and an increased dementia risk, particularly in individuals with concomitant cardiovascular and/or kidney disease. Incretin therapies may modulate this risk via glycemic and nonglycemic pathways. We explored if the dipeptidyl peptidase 4 inhibitor linagliptin could prevent cognitive decline in people with type 2 diabetes with cardiorenal disease. RESEARCH DESIGN AND METHODS The CArdiovascular and Renal Microvascular outcomE study with LINAgliptin (CARMELINA)-COG substudy was an integral part of CARMELINA (NCT01897532) that randomized participants with cardiorenal disease to linagliptin 5 mg or placebo once daily (1:1), in addition to standard of care. The primary cognitive outcome was the occurrence of accelerated cognitive decline at the end of treatment, defined as a regression-based index score ≤16th percentile on the Mini-Mental State Examination (MMSE) or a composite measure of attention and executive functioning and analyzed in participants with a baseline MMSE ≥24. Effects across subgroups by baseline factors, as well as absolute cognitive changes, were also assessed. RESULTS Of the 6,979 participants in CARMELINA, CARMELINA-COG included 1,545 (mean ± SD age, 68 ± 8 years; MMSE, 28.3 ± 1.7; estimated glomerular filtration rate, 52 ± 23 mL/min/1.73 m 2 ; and HbA 1c , 7.8 ± 0.9% [61.4 ± 10.1 mmol/mol]). Over a median treatment duration of 2.5 years, accelerated cognitive decline occurred in 28.4% (linagliptin) vs. 29.3% (placebo) (odds ratio 0.96 [95% CI 0.77, 1.19]). Consistent effects were observed across subgroups by baseline characteristics. Absolute cognitive performance changes were also similar between treatment groups. CONCLUSIONS In a large international cardiovascular outcome trial in people with type 2 diabetes and cardiorenal disease, linagliptin did not modulate cognitive decline over 2.5 years.",2019,"Absolute cognitive performance changes were also similar between treatment groups. ","['people with type 2 diabetes and cardiorenal disease', 'individuals with concomitant cardiovascular and/or kidney disease', 'randomized participants with cardiorenal disease to', 'Patients With Type 2 Diabetes and Cardiorenal Comorbidities', '6,979 participants in CARMELINA', 'people with type 2 diabetes with cardiorenal disease']","['Linagliptin', 'LINAgliptin', 'linagliptin 5 mg or placebo', 'dipeptidyl peptidase 4 inhibitor linagliptin', 'linagliptin']","['accelerated cognitive decline', 'Absolute cognitive performance changes', 'occurrence of accelerated cognitive decline at the end of treatment, defined as a regression-based index score ≤16th percentile on the Mini-Mental State Examination (MMSE) or a composite measure of attention and executive functioning', 'cognitive decline', 'Cognitive Performance']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease (disorder)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.508857,"Absolute cognitive performance changes were also similar between treatment groups. ","[{'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Biessels', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands g.j.biessels@umcutrecht.nl.'}, {'ForeName': 'Chloë', 'Initials': 'C', 'LastName': 'Verhagen', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'Janssen', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van den Berg', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Dallas, TX.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Therapeutic Area Cardiometabolism, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Passera', 'Affiliation': 'HMS Analytical Software GmbH, Sulzbach, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim, Biberach, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0783'] 1487,22364776,"Attention-deficit/hyperactivity disorder (ADHD) symptoms, craving to smoke, and tobacco withdrawal symptoms in adult smokers with ADHD.","BACKGROUND Tobacco withdrawal symptoms may be confounded with attention-deficit/hyperactivity disorder (ADHD) symptoms among smokers with ADHD. OBJECTIVE (1) To assess overlap between ADHD symptoms and tobacco/nicotine withdrawal symptoms and craving; (2) to assess the relationship between craving or withdrawal symptoms and the effect of osmotic-release oral system methylphenidate (OROS-MPH) on ADHD symptoms; (3) to assess the association of ADHD symptoms, craving, and withdrawal symptoms with abstinence. METHODS Secondary analysis of a randomized, placebo controlled smoking cessation trial assessing the efficacy of OROS-MPH taken in addition to nicotine patch among individuals with ADHD. ADHD symptoms, withdrawal symptoms, and craving were assessed at baseline and 2, 4 and 6 weeks after a target quit day. RESULTS Withdrawal symptoms and craving showed limited and modest overlap with ADHD symptoms prior to abstinence but more extensive and stronger correlation after quit day. Compared to placebo, OROS-MPH reduced ADHD symptoms; this effect was attenuated by controlling for withdrawal symptoms, but not by craving. Craving, but not ADHD symptoms and withdrawal symptoms, was associated with abstinence during the trial. CONCLUSION When treating smokers with ADHD (1) craving, rather than tobacco withdrawal symptoms or ADHD symptoms may be the more effective therapeutic smoking cessation targets; (2) careful distinction of craving, withdrawal symptoms, and ADHD symptoms when assessing withdrawal phenomena is needed.",2012,"Compared to placebo, OROS-MPH reduced ADHD symptoms; this effect was attenuated by controlling for withdrawal symptoms, but not by craving.","['smokers with ADHD', 'individuals with ADHD', 'adult smokers with ADHD', 'smokers with ADHD (1) craving, rather than tobacco withdrawal symptoms or ADHD symptoms']","['OROS-MPH', 'nicotine patch', 'placebo', 'osmotic-release oral system methylphenidate (OROS-MPH']","['ADHD symptoms, withdrawal symptoms, and craving', 'OROS-MPH reduced ADHD symptoms', 'ADHD symptoms and withdrawal symptoms', 'ADHD symptoms, craving, and withdrawal symptoms with abstinence', 'ADHD) symptoms, craving to smoke, and tobacco withdrawal symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1167842', 'cui_str': 'Tobacco withdrawal symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1167842', 'cui_str': 'Tobacco withdrawal symptoms'}]",,0.118462,"Compared to placebo, OROS-MPH reduced ADHD symptoms; this effect was attenuated by controlling for withdrawal symptoms, but not by craving.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Berlin', 'Affiliation': ""Département de Pharmacologie, Hôpital Pitié-Salpêtrière, AP-HP, Faculté de médicine, Université P. & M. Curie--INSERM U894, 47, bd de l'Hôpital, 75013 Paris, France. ivan.berlin@psl.aphp.fr""}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2012.01.019'] 1488,32422285,Randomized trial of topical periocular castor oil treatment for blepharitis.,"PURPOSE To evaluate the effects of topical castor oil application to the eyelids on ocular surface and tear film parameters in patients with blepharitis. METHODS Twenty-six participants (14 females, 12 males; mean ± SD age, 38 ± 21 years) with clinical signs of blepharitis were enrolled in a prospective, investigator-masked, randomized, paired-eye trial. A 100% cold pressed castor oil formulation (Lotus Garden Botanicals, Biddeford, ME, USA) was applied to the eyelids of one eye (randomized), twice daily for 4 weeks. Ocular surface characteristics, symptoms, and tear film parameters were assessed at baseline and day 28. RESULTS Baseline measurements did not differ between treated and control eyes (all p > 0.05). A significant reduction in OSDI symptomology score was observed following the four-week treatment period (p = 0.001). Clinical improvements in eyelid margin thickening, telangiectasia, eyelash matting, madarosis, cylindrical dandruff, and lid wiper epitheliopathy were limited to treated eyes (all p < 0.01), while greater decreases in staphylococcal and seborrheic eyelash crusting were observed in treated than control eyes (both p < 0.05). No adverse events were reported during the treatment period. CONCLUSION Topical castor oil application effected significant improvements in ocular surface signs and symptoms in patients with blepharitis. The favourable therapeutic profile would suggest that castor oil demonstrates promise as a potential treatment for blepharitis, and support the conduct of further efficacy trials with longer follow up. TRIAL REGISTRATION NUMBER ACTRN12618000856213.",2020,"RESULTS Baseline measurements did not differ between treated and control eyes (all p > 0.05).","['Twenty-six participants (14 females, 12 males; mean\u202f±\u202fSD age, 38\u202f±\u202f21 years) with clinical signs of blepharitis', 'patients with blepharitis', 'blepharitis']","['topical castor oil application', 'cold pressed castor oil formulation (Lotus Garden Botanicals, Biddeford, ME, USA', 'topical periocular castor oil treatment', 'castor oil']","['staphylococcal and seborrheic eyelash crusting', 'Ocular surface characteristics, symptoms, and tear film parameters', 'OSDI symptomology score', 'ocular surface and tear film parameters', 'adverse events', 'ocular surface signs and symptoms', 'eyelid margin thickening, telangiectasia, eyelash matting, madarosis, cylindrical dandruff, and lid wiper epitheliopathy']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0007343', 'cui_str': 'Castor Oil'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0330839', 'cui_str': 'Lotus'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015422', 'cui_str': 'Structure of eyelash'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0271321', 'cui_str': 'Madarosis of eyelid'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0221244', 'cui_str': 'Seborrheic dermatitis of scalp'}]",26.0,0.0298868,"RESULTS Baseline measurements did not differ between treated and control eyes (all p > 0.05).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Muntz', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sandford', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Tauranga Eye Specialists, Tauranga, New Zealand.'}, {'ForeName': 'Marna', 'Initials': 'M', 'LastName': 'Claassen', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Curd', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Jackson', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Watters', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}]",The ocular surface,['10.1016/j.jtos.2020.05.007'] 1489,31834138,Effects of a Transdiagnostic Preventive Intervention on Anxiety and Depression Among Workers in Japan: A Pre- and Posttest Study.,"OBJECTIVE This study examined the effectiveness of a newly developed transdiagnostic preventive intervention for anxiety and depressive symptoms among workers in a pre- and posttest study design. METHODS Participants were recruited from six companies and one medical clinic. The program was developed based on Unified Protocol. The outcomes were anxiety symptoms (GAD7), depressive symptoms (BDI-II), and psychological distress (K6), measured at baseline, 3-week, and 6-week follow-up. A mixed model for repeated measures was conducted for the whole sample and for a subgroup with higher psychological distress. RESULTS Among 75 participants, this program showed no significant effects on improving any outcome in the whole sample, but a significant improvement of psychological distress among the high-distress subgroup. CONCLUSIONS The program may be effective in improving psychological distress among those who have high symptom levels.",2020,"Among 75 participants, this program showed no significant effects on improving any outcome in the whole sample, but a significant improvement of psychological distress among the high-distress subgroup. ","['Participants were recruited from six companies and one medical clinic', 'Workers in Japan', '75 participants', 'anxiety and depressive symptoms among workers in a pre- and posttest study design']","['Transdiagnostic Preventive Intervention', 'transdiagnostic preventive intervention']","['psychological distress', 'anxiety symptoms (GAD7), depressive symptoms (BDI-II), and psychological distress (K6', 'Anxiety and Depression']","[{'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",75.0,0.0259193,"Among 75 participants, this program showed no significant effects on improving any outcome in the whole sample, but a significant improvement of psychological distress among the high-distress subgroup. ","[{'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Hidaka', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan (Dr Hidaka, Dr Imamura, Dr Sekiya, Dr Watanabe, and Dr Kawakami).'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Imamura', 'Affiliation': ''}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sekiya', 'Affiliation': ''}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001796'] 1490,22971593,The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial.,"BACKGROUND The President's National HIV/AIDS Strategy calls for coupling HIV screening and prevention services with substance abuse treatment programs. Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral. METHODS We measured the cost-effectiveness of three HIV testing strategies evaluated in a randomized trial conducted in 12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk-reduction counseling. Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence (0.4%) and program costs. The Cost-Effectiveness of Preventing AIDS Complications (CEPAC) computer simulation model was used to project life expectancy, lifetime costs, and quality-adjusted life years (QALYs) for HIV-infected individuals. Incremental cost-effectiveness ratios (2009 US $/QALY) were calculated after adding costs of testing HIV-uninfected individuals; costs and QALYs were discounted at 3% annually. RESULTS Referral for off-site testing is less efficient (dominated) compared to offering on-site testing with information only. The cost-effectiveness ratio for on-site testing with information is $60,300/QALY in the base case, or $76,300/QALY with 0.1% undiagnosed HIV prevalence. HIV risk-reduction counseling costs $36 per person more without additional benefit. CONCLUSIONS A strategy of on-site rapid HIV testing offer with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio <$100,000/QALY. Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested.",2013,Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested.,"['12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk-reduction counseling', 'substance abuse treatment']",['rapid HIV testing'],"['Cost-Effectiveness', 'life expectancy', 'project life expectancy, lifetime costs, and quality-adjusted life years (QALYs', 'cost-effectiveness ratio', 'Incremental cost-effectiveness ratios', 'HIV risk-reduction counseling costs', 'cost-effectiveness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0446511,Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested.,"[{'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Public Health, Weill Cornell Medical College, 402 East 67th Street, New York, NY 10065, USA. brs2006@med.cornell.edu'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': ''}, {'ForeName': 'Grant N', 'Initials': 'GN', 'LastName': 'Colfax', 'Affiliation': ''}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Callie A', 'Initials': 'CA', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Gooden', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': ''}, {'ForeName': 'Louise F', 'Initials': 'LF', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Paltiel', 'Affiliation': ''}, {'ForeName': 'Rochelle P', 'Initials': 'RP', 'LastName': 'Walensky', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2012.08.009'] 1491,22661830,"Adjunctive cognitive remediation for schizophrenia using yoga: an open, non-randomized trial.","BACKGROUND: Yoga therapy (YT) improves cognitive function in healthy individuals, but its impact on cognitive function among persons with schizophrenia (SZ) has not been investigated. AIMS: Evaluate adjunctive YT for cognitive domains impaired in SZ. METHODS: Patients with SZ received YT or treatment as usual (TAU; n = 65, n = 23, respectively). Accuracy and speed for seven cognitive domains were assessed using a computerized neurocognitive battery (CNB), thus minimizing observer bias. Separately, YT was evaluated among patients with Bipolar I disorder (n = 40), Major Depressive Disorder (n = 37), and cardiology outpatients (n = 68). All patients also received routine pharmacotherapy. Patients were not randomized to YT or TAU. RESULTS: Compared with the SZ/TAU group, the SZ/YT group showed significantly greater improvement with regard to measures of attention following corrections for multiple comparisons; the changes were more prominent among the men. In the other diagnostic groups, differing patterns of improvements were noted with small to medium effect sizes. CONCLUSIONS: Our initial analyses suggest nominally significant improvement in cognitive function in schizophrenia with adjunctive therapies such as YT. The magnitude of the change varies by cognitive domain and may also vary by diagnostic group.",2012,"Compared with the SZ/TAU group, the SZ/YT group showed significantly greater improvement with regard to measures of attention following corrections for multiple comparisons; the changes were more prominent among the men.","['persons with schizophrenia (SZ', 'healthy individuals', 'patients with Bipolar I disorder (n = 40), Major Depressive Disorder (n = 37), and cardiology outpatients (n = 68']","['Yoga therapy (YT', 'routine pharmacotherapy', 'SZ/TAU']","['cognitive function', 'Accuracy and speed for seven cognitive domains']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",68.0,0.0526059,"Compared with the SZ/TAU group, the SZ/YT group showed significantly greater improvement with regard to measures of attention following corrections for multiple comparisons; the changes were more prominent among the men.","[{'ForeName': 'Triptish', 'Initials': 'T', 'LastName': 'Bhatia', 'Affiliation': 'Training Program for Psychiatric Genetics in India, Post-graduate Institute for Medical Education and Research, Dr Ram Manohar Lohia Hospital, Delhi, India.'}, {'ForeName': 'Akhilesh', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': ''}, {'ForeName': 'Gyandeepak', 'Initials': 'G', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Richard', 'Affiliation': ''}, {'ForeName': 'Raquel E', 'Initials': 'RE', 'LastName': 'Gur', 'Affiliation': ''}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': ''}, {'ForeName': 'Vishwajit L', 'Initials': 'VL', 'LastName': 'Nimgaonkar', 'Affiliation': ''}, {'ForeName': 'Sati', 'Initials': 'S', 'LastName': 'Mazumdar', 'Affiliation': ''}, {'ForeName': 'Smita N', 'Initials': 'SN', 'LastName': 'Deshpande', 'Affiliation': ''}]",Acta neuropsychiatrica,[] 1492,31539295,Negative Hyperselection of Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer Who Received Panitumumab-Based Maintenance Therapy.,"PURPOSE We assessed the prognostic/predictive role of primary tumor sidedness and uncommon alterations of anti-epidermal growth factor receptor (EGFR) primary resistance (primary resistance in RAS and BRAF wild-type metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with RAS / BRAF wild-type (wt) metastatic colorectal cancer (mCRC) who were randomly assigned to panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino trial (ClinicalTrials.gov identifier: NCT02476045). PATIENTS AND METHODS This prespecified retrospective analysis included 199 evaluable patients with RAS / BRAF wt. The PRESSING panel included the following: immunohistochemistry (IHC) and in situ hybridization for HER2/MET amplification, IHC with or without RNA sequencing for ALK/ROS1/NTRKs/RET fusions, next-generation sequencing for HER2 / PIK3CAex.20/PTEN / AKT1 and RAS mutations with low mutant allele fraction, and multiplex polymerase chain reaction for microsatellite instability. PRESSING status (any positive biomarker v all negative) and sidedness were correlated with overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) in the study population and by treatment arm. RESULTS Overall, left- and right-sided tumors were 85.4% and 14.6%, respectively, and PRESSING-negative and -positive tumors were 75.4% and 24.6%, respectively. At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2% v 74.1%; P = .037), PFS (8.4 v 11.5 months; P = .026), and OS (2-year rate: 50.2% v 65.1%; P = .062). Similar results were observed in the PRESSING-positive versus PRESSING-negative subgroup for ORR (59.2% v 75.3%; P = .030), PFS (7.7 v 12.1 months; P < .001), and OS (2-year rate: 48.1% v 68.1%; P = .021). The PFS benefit of FU plus LV added to panitumumab maintenance, reported in the study, was independent from sidedness and PRESSING status (interaction for PFS P = .293 and .127, respectively). However, outcomes were extremely poor in patients who received single-agent panitumumab and had right-sided tumors (median PFS, 7.7 months; 2-year OS, 38.5%) or PRESSING-positive tumors (median PFS, 7.4 months; 2-year OS, 47.0%). CONCLUSION The combined assessment of sidedness and molecular alterations of anti-EGFR primary resistance identified a consistent proportion of patients with RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs.",2019,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2% v 74.1%; P = .037), PFS (8.4 v 11.5 months; P = .026), and OS (2-year rate: 50.2% v 65.1%; P = .062).","['199 evaluable patients with RAS / BRAF wt', 'Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer', 'patients with RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs', 'metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with RAS / BRAF wild-type (wt) metastatic colorectal cancer (mCRC']","['Panitumumab-Based Maintenance Therapy', 'panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino']","['Overall, left- and right-sided tumors', 'overall response rate (ORR), progression-free survival (PFS), and overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",199.0,0.168706,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2% v 74.1%; P = .037), PFS (8.4 v 11.5 months; P = .026), and OS (2-year rate: 50.2% v 65.1%; P = .062).","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Humanitas Cancer Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Murialdo', 'Affiliation': 'University of Genoa and IRCCS Azienda Ospedaliera Universitaria (AOU) San Martino-IST, Genoa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sartore-Bianchi', 'Affiliation': 'Niguarda Cancer Center, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Azienda Socio-Sanitaria Territoriale Ospedale di Cremona, Cremona, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Racca', 'Affiliation': 'AOU Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Adamo', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Annunziata', 'Initials': 'A', 'LastName': 'Gloghini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Busico', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Palermo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milione', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01254'] 1493,31577396,Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm.,"BACKGROUND Moderate therapeutic hypothermia is currently recommended to improve neurologic outcomes in adults with persistent coma after resuscitated out-of-hospital cardiac arrest. However, the effectiveness of moderate therapeutic hypothermia in patients with nonshockable rhythms (asystole or pulseless electrical activity) is debated. METHODS We performed an open-label, randomized, controlled trial comparing moderate therapeutic hypothermia (33°C during the first 24 hours) with targeted normothermia (37°C) in patients with coma who had been admitted to the intensive care unit (ICU) after resuscitation from cardiac arrest with nonshockable rhythm. The primary outcome was survival with a favorable neurologic outcome, assessed on day 90 after randomization with the use of the Cerebral Performance Category (CPC) scale (which ranges from 1 to 5, with higher scores indicating greater disability). We defined a favorable neurologic outcome as a CPC score of 1 or 2. Outcome assessment was blinded. Mortality and safety were also assessed. RESULTS From January 2014 through January 2018, a total of 584 patients from 25 ICUs underwent randomization, and 581 were included in the analysis (3 patients withdrew consent). On day 90, a total of 29 of 284 patients (10.2%) in the hypothermia group were alive with a CPC score of 1 or 2, as compared with 17 of 297 (5.7%) in the normothermia group (difference, 4.5 percentage points; 95% confidence interval [CI], 0.1 to 8.9; P = 0.04). Mortality at 90 days did not differ significantly between the hypothermia group and the normothermia group (81.3% and 83.2%, respectively; difference, -1.9 percentage points; 95% CI, -8.0 to 4.3). The incidence of prespecified adverse events did not differ significantly between groups. CONCLUSIONS Among patients with coma who had been resuscitated from cardiac arrest with nonshockable rhythm, moderate therapeutic hypothermia at 33°C for 24 hours led to a higher percentage of patients who survived with a favorable neurologic outcome at day 90 than was observed with targeted normothermia. (Funded by the French Ministry of Health and others; HYPERION ClinicalTrials.gov number, NCT01994772.).",2019,"Mortality at 90 days did not differ significantly between the hypothermia group and the normothermia group (81.3% and 83.2%, respectively; difference, -1.9 percentage points; 95% CI, -8.0 to 4.3).","['patients with nonshockable rhythms (asystole or pulseless electrical activity', 'From January 2014 through January 2018, a total of 584 patients from 25 ICUs underwent randomization, and 581 were included in the analysis (3 patients withdrew consent', 'adults with persistent coma after resuscitated out-of-hospital cardiac arrest', 'patients with coma who had been admitted to the intensive care unit (ICU) after resuscitation from cardiac arrest with nonshockable rhythm', 'patients with coma who had been resuscitated from cardiac arrest with nonshockable rhythm, moderate']",['moderate therapeutic hypothermia (33°C during the first 24 hours) with targeted normothermia'],"['survival with a favorable neurologic outcome', 'incidence of prespecified adverse events', 'Cerebral Performance Category (CPC) scale', 'Mortality', 'Mortality and safety', 'neurologic outcomes', 'alive with a CPC score', 'therapeutic hypothermia', 'favorable neurologic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0222045'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}]",584.0,0.122199,"Mortality at 90 days did not differ significantly between the hypothermia group and the normothermia group (81.3% and 83.2%, respectively; difference, -1.9 percentage points; 95% CI, -8.0 to 4.3).","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Merdji', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Gwenhael', 'Initials': 'G', 'LastName': 'Colin', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Grillet', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Girardie', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Coupez', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Boulain', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Brule', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pichon', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Landais', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Plantefeve', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Chakarian', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Sirodot', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Legriel', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Letheulle', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Thevenin', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Desachy', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Delahaye', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Botoc', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Vimeux', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Martino', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reignier', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1906661'] 1494,20855467,Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma.,"BACKGROUND Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®)) is made by covalently conjugating the essential fatty acid DHA to the paclitaxel molecule. Preclinical studies of DHA-paclitaxel have demonstrated increased activity relative to paclitaxel and the potential for an improved therapeutic ratio. In the present study, the efficacy and toxicity profiles of DHA-paclitaxel were compared with those of dacarbazine. METHODS In this study, 393 chemonaive patients with metastatic melanoma were randomly assigned to receive either DHA-paclitaxel at a starting dose of 900 mg/m(2) IV on day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m(2) IV on day 1 every 3 weeks. The primary end point of the study was the comparison of overall survival (OS). RESULTS No significant difference in OS was noted between patients in the DHA-paclitaxel and dacarbazine arms. Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs. Safety results of the two drugs were as predicted from prior studies. Myelosuppression was more common with DHA-paclitaxel. CONCLUSIONS DHA-paclitaxel was not superior to dacarbazine. We conclude that further studies with the drug on an every 3-week schedule in melanoma are not warranted.",2011,"Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs.","['patients with metastatic malignant melanoma', '393 chemonaive patients with metastatic melanoma']","['dacarbazine', 'Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®', 'docosahexaenoic acid-paclitaxel versus dacarbazine', 'DHA-paclitaxel']","['OS', 'Myelosuppression', 'efficacy and toxicity profiles', 'overall survival (OS', 'response rate, duration of response, time to progression, and time to treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860594', 'cui_str': 'Malignant melanoma, metastatic'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C1134470', 'cui_str': 'DHA-paclitaxel'}, {'cui': 'C1135143', 'cui_str': 'Taxoprexin'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",393.0,0.327994,"Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs.","[{'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Bedikian', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston. Electronic address: abedikia@mdanderson.org.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'DeConti', 'Affiliation': 'Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'Division of Hematology & Oncology, Kirkland Clinic at Acton Road, Birmingham.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agarwala', 'Affiliation': ""Department of Hematology/Oncology, St Luke's Cancer Center, Bethlehem.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Papadopoulos', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Kim', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ernstoff', 'Affiliation': 'Department of Hematology/Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq438'] 1495,31714584,The economic research of arsenic trioxide for the treatment of newly diagnosed acute promyelocytic leukemia in China.,"BACKGROUND The objective of this study was to conduct the first systematic evaluation of the long-term economic impact of arsenic trioxide (ATO) plus all-trans retinoic acid (ATRA) for the treatment of patients with newly diagnosed acute promyelocytic leukemia (APL) from the perspective of the Chinese health care system. METHODS On the basis of clinical data from a randomized phase 3 trial, a time-dependent Markov model with 4 health states (complete remission, relapse or treatment failure, post-treatment failure, and death) was used to evaluate the incremental costs per quality-adjusted life-year (QALY) gained from the ATO plus ATRA regimen compared with the ATRA plus chemotherapy (CT) regimen over a 30-year period. All costs were adjusted to 2018 levels based on the Chinese Consumer Price Index. Both costs and health outcomes were discounted by 3% annually. One-way sensitivity analysis and probability sensitivity analysis were performed. RESULTS Compared with the ATRA plus CT strategy, the ATO plus ATRA strategy was associated with 1.38 additional QALYs gained and $392.05 (estimated in 2018 US dollars) in incremental costs per patient over 30 years. Consequently, the incremental cost-effectiveness ratio was $284.02 per QALY gained, which was far below the Chinese willingness-to-pay threshold of $29,306 per QALY gained. Sensitivity analyses demonstrated the robustness of these results. CONCLUSIONS From the perspective of the Chinese health care system, the ATO plus ATRA strategy is cost-effective for patients with newly diagnosed APL compared with the ATRA plus CT strategy. Therefore, the authors strongly suggest that China's health authorities choose the former strategy for these patients, whether for the elderly or for young people.",2020,"Compared with the ATRA plus CT strategy, the ATO plus ATRA strategy was associated with 1.38 additional QALYs gained and $392.05 (estimated in 2018 US dollars) in incremental costs per patient over 30 years.","['patients with newly diagnosed acute promyelocytic leukemia (APL) from the perspective of the Chinese health care system', 'newly diagnosed acute promyelocytic leukemia in China', 'patients with newly diagnosed APL']","['ATRA plus CT', 'ATRA plus chemotherapy (CT', 'arsenic trioxide', 'arsenic trioxide (ATO) plus all-trans retinoic acid (ATRA']","['incremental cost-effectiveness ratio', 'costs and health outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0820965,"Compared with the ATRA plus CT strategy, the ATO plus ATRA strategy was associated with 1.38 additional QALYs gained and $392.05 (estimated in 2018 US dollars) in incremental costs per patient over 30 years.","[{'ForeName': 'Xichuang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Pharmacy, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': ""Department of Pharmacy, Wuxi Children's Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, Ningbo No. 6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'You', 'Affiliation': ""Department of Pharmacy, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""Department of Pharmacy, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Zhihu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Oncology, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Wuxi Children's Hospital, Wuxi, Jiangsu, China.""}]",Cancer,['10.1002/cncr.32519'] 1496,20696676,"A randomized phase II study comparing induction or consolidation chemotherapy with cisplatin-docetaxel, plus radical concurrent chemoradiotherapy with cisplatin-docetaxel, in patients with unresectable locally advanced non-small-cell lung cancer.","BACKGROUND In stage III non-small-cell lung cancer (NSCLC), the role of systemic chemotherapy preceding or following concurrent chemo-radiotherapy (CT-RT) is unclear. We carried out a randomized phase II study to study the toxicity involved-field CT-RT with either induction or consolidation cisplatin-docetaxel (Taxotere). PATIENTS AND METHODS Patients were randomly assigned to receive two cycles of docetaxel (D) 75 mg/m(2) on day 1 and cisplatin (C) 40 mg/m(2) on days 1 and 2, either preceding (IND arm) or following (CON arm) concurrent CT-RT, where 66 Gy was delivered using involved-fields concurrent with weekly D 20 mg/m(2) and C 20 mg/m(2). Patients at higher risk for lung toxicity (V(20) > 35%) crossed over to IND arm. Seventy patients were needed to exclude grade (G)3-4 esophagitis in >25%. RESULTS Of the 70 eligible patients, 26 were treated in IND and 34 CON; five with V(20) >35% switched from CON to IND. The differences in G3-4 esophagitis observed (32/2% IND versus 21/3% CON) were not significantly different from the hypothesized 25% rate. Rates of G≥2 pneumonitis were similar, but IND arm had less G3-4 neutropenia. One-year survival was 63.2% [95% confidence interval (CI) 48.4% to 78.0%] and 65.5% (95% CI 48.2% to 82.8%) for the IND and CON arms, respectively. CONCLUSION Both study arms merit further testing in patients with limited volume stage III NSCLC.",2011,"One-year survival was 63.2% [95% confidence interval (CI) 48.4% to 78.0%] and 65.5% (95% CI 48.2% to 82.8%) for the IND and CON arms, respectively. ","['70 eligible patients', ' 26 were treated in IND and 34 CON; five with V(20', 'Patients at higher risk for lung toxicity (V(20) > 35%) crossed over to IND arm', 'Patients', 'patients with limited volume stage III NSCLC', 'Seventy patients were needed to exclude grade (G)3-4 esophagitis in >25', 'patients with unresectable locally advanced non-small-cell lung cancer']","['concurrent chemo-radiotherapy (CT-RT', 'consolidation cisplatin-docetaxel (Taxotere', 'consolidation chemotherapy with cisplatin-docetaxel, plus radical concurrent chemoradiotherapy with cisplatin-docetaxel', 'docetaxel (D) 75 mg/m(2) on day 1 and cisplatin (C) 40 mg/m(2) on days 1 and 2, either preceding (IND arm) or following (CON arm) concurrent CT-RT']","['Rates of G≥2 pneumonitis', 'G3-4 esophagitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]",70.0,0.0831541,"One-year survival was 63.2% [95% confidence interval (CI) 48.4% to 78.0%] and 65.5% (95% CI 48.2% to 82.8%) for the IND and CON arms, respectively. ","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, VU Medical Center, Amsterdam, The Netherlands. Electronic address: s.senan@vumc.nl.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cardenal', 'Affiliation': ""Department of Medical Oncology, Institut Catala d'Oncologia, Barcelona, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Respiratory Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stigt', 'Affiliation': 'Isala Klinieken, Pulmonology, Zwolle, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Akyol', 'Affiliation': 'Department of Radiation Oncology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Medical Affairs and Clinical Operations, sanofi-aventis, Gouda, The Netherlands.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Dupont', 'Affiliation': 'PRA-International, Paris, France.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Thoracic Oncology, San Luigi Hospital.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Ricardi', 'Affiliation': 'Department of Radiation Oncology, Ospedal San Giovanni Battista, University of Torino, Torino, Italy.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'van Meerbeeck', 'Affiliation': 'Department of Thoracic Oncology, Ghent University Hospital, Gent, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq388'] 1497,21567262,Α-defensin expression of inflammatory response in open and laparoscopic colectomy for colorectal cancer.,"BACKGROUND Surgical procedures are related to the activation of the inflammatory reaction. This is called surgical stress. It is believed that diminished surgical trauma reduces surgical stress. The laparoscopic approach reduces trauma, but the systemic immune responses are still invariably activated. Cytokines and C-reactive protein (CRP) are the main markers in the study of inflammatory or stress response. α-Defensins play an important role in host defense, acting early in phagocytosis. α-Defensins, as early markers-earlier than cytokines-of the inflammatory response, have been used, together with high-sensitivity CRP (hs-CRP) and interleukin-6 (IL-6), to determine the inflammatory response in laparoscopic and open colectomy for cancer. MATERIALS AND METHODS A total of 40 patients with colorectal cancer were randomized to two groups: group A (n = 20), open colectomy; group B (n = 20), laparoscopic colectomy. One hour preoperatively an epidural catheter was placed in all patients and rupivacaine was administered perioperatively and again 48 h postoperatively. Blood samples were taken for calculating α-defensins, IL-6, and hs-CRP levels preoperatively, 5 min after division of the colon (group A), or 5 min after deflation of pneumoperitoneum (group B), 6 h and 24 h postoperatively. RESULTS The mean operative time was 115 min for group A and 142 min for group B (p < 0.05). The mean blood loss was 240 ml and 105 ml, respectively (p < 0.001). The mean hospital stay was 8 days and 5 days, respectively (p < 0.05). α-Defensin levels were statistically significantly lower in group B than in group A, 5 min and 24 h postoperatively (p < 0.002 and p < 0.007, respectively). The IL-6 levels were statistically significantly lower in group B than in group A, 6 h and 24 h postoperatively (p < 0.0001 at both time intervals), whereas the levels of hs-CRP were significantly lower in group B than in group A 24 h postoperatively (p < 0.001). CONCLUSIONS The present study confirms the results of previous studies, that the inflammatory immune response and surgical stress are significantly less after laparoscopic colectomy versus open colectomy for colorectal cancer. More investigation is needed to study if surgical stress has any influence on survival of these patients.",2011,"α-Defensin levels were statistically significantly lower in group B than in group A, 5 min and 24 h postoperatively (p < 0.002 and p < 0.007, respectively).","['colorectal cancer', '40 patients with colorectal cancer']","['rupivacaine', 'open colectomy', 'laparoscopic colectomy versus open colectomy', 'laparoscopic colectomy']","['mean hospital stay', 'IL-6 levels', 'α-Defensin levels', 'mean blood loss', 'levels of hs-CRP', 'Α-defensin expression of inflammatory response', 'mean operative time']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0057256', 'cui_str': 'Defensins'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",40.0,0.0357961,"α-Defensin levels were statistically significantly lower in group B than in group A, 5 min and 24 h postoperatively (p < 0.002 and p < 0.007, respectively).","[{'ForeName': 'Konstantinos E', 'Initials': 'KE', 'LastName': 'Tsimogiannis', 'Affiliation': 'Department of Surgery, ""G. Hatzikosta"" General Hospital, Ioannina, Greece. ktsimogiannis@gmail.com'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Telis', 'Affiliation': ''}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Tselepis', 'Affiliation': ''}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Pappas-Gogos', 'Affiliation': ''}, {'ForeName': 'Evangelos C', 'Initials': 'EC', 'LastName': 'Tsimoyiannis', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Basdanis', 'Affiliation': ''}]",World journal of surgery,['10.1007/s00268-011-1140-5'] 1498,31941381,Homocysteine Level Predicts Response to Dual Antiplatelet in Women With Minor Stroke or Transient Ischemic Attack: Subanalysis of the CHANCE Trial.,"OBJECTIVES To investigate the relationship of homocysteine levels with the efficacy and safety of dual antiplatelet therapy in female and male patients. Approach and Results: The CHANCE trial (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events) randomized patients with acute minor ischemic stroke or high-risk transient ischemic attack to clopidogrel plus aspirin or aspirin alone from October 1, 2009, to July 30, 2012, in China. A subgroup of 3044 consecutive patients with baseline homocysteine levels from 73 (64%) prespecified clinical sites was analyzed. Participants were grouped by sex. Primary outcome was stroke recurrence within 90 days. Secondary outcomes consisted of composite vascular events and independent living or death. Safety outcome was any bleeding. Cox proportional-hazards models were used to assess the interaction of homocysteine levels with randomized antiplatelet therapy on efficacy and safety outcomes. A significant interaction between homocysteine levels and the randomized antiplatelet therapies was found on recurrent stroke after adjustment for confounding factors in women ( P =0.010) but not in men ( P =0.595). Compared with aspirin alone, clopidogrel plus aspirin significantly reduced the risk of recurrent stroke in women without elevated homocysteine levels (adjusted hazard ratio, 0.459 [95% CI, 0.271-0.776]; P =0.004). Such benefit disappeared in female patients with increased homocysteine level. No significant interaction on functional outcome or bleeding rate was observed. CONCLUSIONS Homocysteine could be a potential biomarker to discriminate the effects of dual and single antiplatelet therapy in female patients with minor ischemic stroke or high-risk transient ischemic attack. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00979589.",2020,A significant interaction between homocysteine levels and the randomized antiplatelet therapies was found on recurrent stroke after adjustment for confounding factors in women ( P =0.010) but not in men ( P =0.595).,"['female patients with increased homocysteine level', 'Women With Minor Stroke or Transient Ischemic Attack', '3044 consecutive patients with baseline homocysteine levels from 73 (64%) prespecified clinical sites was analyzed', 'alone from October 1, 2009, to July 30, 2012, in China', 'female and male patients', 'High-Risk Patients With Acute Nondisabling Cerebrovascular Events) randomized patients with acute minor ischemic stroke or high-risk transient ischemic attack to', 'female patients with minor ischemic stroke or high-risk transient ischemic attack']","['clopidogrel plus aspirin', 'aspirin', 'clopidogrel plus aspirin or aspirin', 'dual antiplatelet therapy']","['stroke recurrence', 'functional outcome or bleeding rate', 'efficacy and safety outcomes', 'recurrent stroke', 'homocysteine levels', 'bleeding', 'composite vascular events and independent living or death', 'risk of recurrent stroke']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",3044.0,0.246809,A significant interaction between homocysteine levels and the randomized antiplatelet therapies was found on recurrent stroke after adjustment for confounding factors in women ( P =0.010) but not in men ( P =0.595).,"[{'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zuo', 'Affiliation': 'Department of Anesthesiology, University of Virginia Health System, Charlottesville (Z.Z.).'}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Anxin', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (J. Li, Yilong Wang., H.L., J. Lin, A.W., X.Z., L.L., Yongjun Wang).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.119.313741'] 1499,32076003,Short-term and long-term effects of a social network intervention on friendships among university students.,"Informal social relations, such as friendships, are crucial for the well-being and success of students at all levels of education. Network interventions can aim at providing contact opportunities in school settings to prevent the social isolation of individuals and facilitate integration between otherwise segregated social groups. We investigate the short-term and long-term effects of one specific network intervention in an undergraduate cohort freshly admitted to an engineering department ([Formula: see text]). In this intervention, we randomly assigned students into small groups at an introduction event two months prior to their first day at university. The groups were designed to increase mixed-gender contact opportunities. Two months after the intervention, we find a higher rate of friendships, common friends, and mixed-gender friendships in pairs of students who were assigned to the same group than in pairs from different groups (short-term effects). These effects gradually diminish over the first academic year (long-term effects). Using stochastic actor-oriented models, we investigate the long-term trajectory of the intervention effects, while considering alternative network processes, such as reciprocity, transitivity, homophily, and popularity. The results suggest that even though the induced friendship ties are less stable than other friendships, they may serve as early seeds for complex social network processes. Our study shows that simple network interventions can have a pronounced short-term effect and indirect long-term effects on the evolution and structure of student communities.",2020,"Informal social relations, such as friendships, are crucial for the well-being and success of students at all levels of education.","['undergraduate cohort freshly admitted to an engineering department ([Formula', 'friendships among university students']","['specific network intervention', 'social network intervention']",[],"[{'cui': 'C0014279', 'cui_str': 'Engineerings'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",[],,0.0271311,"Informal social relations, such as friendships, are crucial for the well-being and success of students at all levels of education.","[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Boda', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland. zsofia.boda@gess.ethz.ch.'}, {'ForeName': 'Timon', 'Initials': 'T', 'LastName': 'Elmer', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Vörös', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stadtfeld', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland. christoph.stadtfeld@ethz.ch.'}]",Scientific reports,['10.1038/s41598-020-59594-z'] 1500,32430272,Diagnostic efficacy of three suction techniques for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions: protocol for a multicenter randomized cross-over clinical trial.,"BACKGROUND How suction technique affects endoscopic ultrasound-guided tissue acquisition (EUS-TA) remains unclear. A standardized protocol is currently lacking, with most previous studies being restricted to EUS-guided fine-needle aspiration (EUS-FNA). The research related to EUS-guided fine-needle biopsy (EUS-FNB) is sparse. AIMS The aim of this study is to evaluate the diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate of three common suction techniques (standard suction, slow-pull, and wet suction) used for EUS-FNB of solid pancreatic masses. METHODS This is a multicenter single-blind randomized cross-over superiority trial. A total of 300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China. All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization. Cytological and histological specimens obtained with each of the three techniques will be assessed independently. Outcomes among the three suction techniques will be compared. DISCUSSION To the best of our knowledge, this is the largest multicenter randomized cross-over trial designed to determine the optimal suction technique for the diagnosis of solid pancreatic masses. This study may contribute to standardizing the suction technique for EUS-FNB.",2020,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.",['300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China'],"['endoscopic ultrasound-guided fine-needle biopsy', 'three common suction techniques (standard suction, slow-pull, and wet suction']","['diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate', 'Diagnostic efficacy']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",300.0,0.0776443,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.","[{'ForeName': 'Shi-Yu', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, Sichuan Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, Second Clinical Medical Sciences of Jinan University, Shenzhen, Guangdong Province, China.""}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Qingdao University, Medical College of Qingdao University, Qingdao, Shandong Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: zhendjin@126.com.'}, {'ForeName': 'Kai-Xuan', 'Initials': 'KX', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: wangkaixuan224007@163.com.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.026'] 1501,31477545,"Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care in patients with mild-to-moderate hypertension in Sri Lanka: a within-trial and modelled economic evaluation of the TRIUMPH trial.","BACKGROUND Elevated blood pressure incurs a major health and economic burden, particularly in low-income and middle-income countries. The Triple Pill versus Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial showed a greater reduction in blood pressure in patients using fixed-combination, low-dose, triple-pill antihypertensive therapy (consisting of amlodipine, telmisartan, and chlorthalidone) than in those receiving usual care in Sri Lanka. We aimed to assess the cost-effectiveness of the triple-pill strategy. METHODS We did a within-trial (6-month) and modelled (10-year) economic evaluation of the TRIUMPH trial, using the health system perspective. Health-care costs, reported in 2017 US dollars, were determined from trial records and published literature. A discrete-time simulation model was developed, extrapolating trial findings of reduced systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality. The primary outcomes were the proportion of people reaching blood pressure targets (at 6 months from baseline) and disability-adjusted life-years (DALYs) averted (at 10 years from baseline). Incremental cost-effectiveness ratios were calculated to estimate the cost per additional participant achieving target blood pressure at 6 months and cost per DALY averted over 10 years. FINDINGS The triple-pill strategy, compared with usual care, cost an additional US$9·63 (95% CI 5·29 to 13·97) per person in the within-trial analysis and $347·75 (285·55 to 412·54) per person in the modelled analysis. Incremental cost-effectiveness ratios were estimated at $7·93 (95% CI 6·59 to 11·84) per participant reaching blood pressure targets at 6 months and $2842·79 (-28·67 to 5714·24) per DALY averted over a 10-year period. INTERPRETATION Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension. Scaled up investment in the triple pill for hypertension management in Sri Lanka should be supported to address the high population burden of cardiovascular disease. FUNDING Australian National Health and Medical Research Council.",2019,"Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension.","['Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial', 'patients with mild-to-moderate hypertension in Sri Lanka', 'patients with mild-to-moderate hypertension']","['amlodipine, telmisartan, and chlorthalidone', 'Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care', 'Triple Pill versus Usual Care Management']","['disability-adjusted life-years (DALYs) averted', 'systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality', 'proportion of people reaching blood pressure targets', 'blood pressure', 'Incremental cost-effectiveness ratios', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0038088', 'cui_str': 'Ceylon'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.167717,"Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. Electronic address: tlung@georgeinstitute.org.au.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Guggilla', 'Affiliation': 'Department of Population Medicine and Civilization Diseases Prevention, Faculty of Medicine with the Division of Dentistry and Division of Medical Education in English, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India; The George Institute for Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Naik', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Arjuna P', 'Initials': 'AP', 'LastName': 'de Silva', 'Affiliation': 'Department of Medicines, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Senaka', 'Initials': 'S', 'LastName': 'Rajapakse', 'Affiliation': 'Department of Medicines, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Gotabhaya', 'Initials': 'G', 'LastName': 'Ranasinghe', 'Affiliation': 'Institute of Cardiology, National Hospital of Sri Lanka, Colombo, Sri Lanka.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control, New Delhi, India.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Hyderabad, India.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Selak', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Stepien', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Lea-Laba', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30343-2'] 1502,31532518,Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial.,"Importance Parents of children with serious illness, such as cancer, experience high stress and distress. Few parent-specific psychosocial interventions have been evaluated in randomized trials. Objective To determine if individual- or group-based delivery of a novel intervention called Promoting Resilience in Stress Management for Parents (PRISM-P) improves parent-reported resilience compared with usual care. Design, Setting, and Participants This parallel, phase 2 randomized clinical trial with enrollment from December 2016 through December 2018 and 3-month follow-up was conducted at Seattle Children's Hospital. English-speaking parents or guardians of children who were 2 to 24 years old, who had received a diagnosis of a new malignant neoplasm 1 to 10 weeks prior to enrollment, and who were receiving cancer-directed therapy at Seattle Children's Hospital were included. Parents were randomized 1:1:1 to the one-on-one or group PRISM-P intervention or to usual care. Data were analyzed in 2019 (primary analyses from January to March 2019; final analyses in July 2019). Interventions The PRISM-P is a manualized, brief intervention targeting 4 skills: stress management, goal setting, cognitive reframing, and meaning making. For one-on-one delivery, skills were taught privately and in person for 30 to 60 minutes approximately every other week. For group delivery, the same skills were taught in a single session with at least 2 parents present. Main Outcomes and Measures Participants completed patient-reported outcome surveys at enrollment and at 3 months. Linear regression modeling evaluated associations in the intention-to-treat population between each delivery format and the primary outcome (Connor-Davidson Resilience Scale scores, ranging from 0 to 40, with higher scores reflecting greater resilience) and secondary outcomes (benefit finding, social support, health-related quality of life, stress, and distress) at 3 months. Results In total, 94 parents enrolled, were randomized to 1 of the 3 groups, and completed baseline surveys (32 parents in one-on-one sessions, 32 in group sessions, and 30 in usual care). Their median (interquartile range) ages were 35 to 38 (31-44) years across the 3 groups, and they were predominantly white, college-educated mothers. Their children had median (interquartile range) ages of 5 to 8 (3-14) years; slightly more than half of the children were boys, and the most common cancer type was leukemia or lymphoma. One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001). No significant associations were detected between either platform and other parent-reported outcomes. Conclusions and Relevance When delivered individually, PRISM-P was associated with improved parent-reported resilience and benefit finding. This scalable psychosocial intervention may help parents cope and find meaning after their child receives a diagnosis of a serious illness. Trial Registration ClinicalTrials.gov identifier: NCT02998086.",2019,"One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001).","['94 parents enrolled, were randomized to 1 of the 3 groups, and completed baseline surveys (32 parents in one-on-one sessions, 32 in group sessions, and 30 in usual care', 'Their median (interquartile range) ages were 35 to 38 (31-44) years across the 3 groups, and they were predominantly white, college-educated mothers', ""English-speaking parents or guardians of children who were 2 to 24 years old, who had received a diagnosis of a new malignant neoplasm 1 to 10 weeks prior to enrollment, and who were receiving cancer-directed therapy at Seattle Children's Hospital were included"", ""enrollment from December 2016 through December 2018 and 3-month follow-up was conducted at Seattle Children's Hospital"", 'Parents of Children With Cancer (PRISM-P']","['individual- or group-based delivery of a novel intervention called Promoting Resilience in Stress Management for Parents (PRISM-P', 'Stress Management Intervention', 'one or group PRISM-P intervention or to usual care']","['secondary outcomes (benefit finding, social support, health-related quality of life, stress, and distress']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0037438'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",94.0,0.115915,"One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001).","[{'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Children's Core for Biomedical Statistics, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Junkins', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sherr', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kross', 'Affiliation': 'Cambia Palliative Care Center of Excellence, University of Washington, Seattle.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Cambia Palliative Care Center of Excellence, University of Washington, Seattle.'}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.11578'] 1503,31532520,Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial.,"Importance Planning complex operations such as robotic-assisted partial nephrectomy requires surgeons to review 2-dimensional computed tomography or magnetic resonance images to understand 3-dimensional (3-D), patient-specific anatomy. Objective To determine surgical outcomes for robotic-assisted partial nephrectomy when surgeons reviewed 3-D virtual reality (VR) models during operative planning. Design, Setting, and Participants A single-blind randomized clinical trial was performed. Ninety-two patients undergoing robotic-assisted partial nephrectomy performed by 1 of 11 surgeons at 6 large teaching hospitals were prospectively enrolled and randomized. Enrollment and data collection occurred from October 2017 through December 2018, and data analysis was performed from December 2018 through March 2019. Interventions Patients were assigned to either a control group undergoing usual preoperative planning with computed tomography and/or magnetic resonance imaging only or an intervention group where imaging was supplemented with a 3-D VR model. This model was viewed on the surgeon's smartphone in regular 3-D format and in VR using a VR headset. Main Outcomes and Measures The primary outcome measure was operative time. It was hypothesized that the operations performed using the 3-D VR models would have shorter operative time than those performed without the models. Secondary outcomes included clamp time, estimated blood loss, and length of hospital stay. Results Ninety-two patients (58 men [63%]) with a mean (SD) age of 60.9 (11.6) years were analyzed. The analysis included 48 patients randomized to the control group and 44 randomized to the intervention group. When controlling for case complexity and other covariates, patients whose surgical planning involved 3-D VR models showed differences in operative time (odds ratio [OR], 1.00; 95% CI, 0.37-2.70; estimated OR, 2.47), estimated blood loss (OR, 1.98; 95% CI, 1.04-3.78; estimated OR, 4.56), clamp time (OR, 1.60; 95% CI, 0.79-3.23; estimated OR, 11.22), and length of hospital stay (OR, 2.86; 95% CI, 1.59-5.14; estimated OR, 5.43). Estimated ORs were calculated using the parameter estimates from the generalized estimating equation model. Referent group values for each covariate and the corresponding nephrometry score were summed across the covariates and nephrometry score, and the sum was exponentiated to obtain the OR. A mean of the estimated OR weighted by sample size for each nephrometry score strata was then calculated. Conclusions and Relevance This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay. Trial Registration ClinicalTrials.gov identifiers (1 registration per site): NCT03334344, NCT03421418, NCT03534206, NCT03542565, NCT03556943, and NCT03666104.",2019,"This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay. ","['Ninety-two patients (58 men [63%]) with a mean (SD) age of 60.9 (11.6) years were analyzed', 'Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes', 'Ninety-two patients undergoing robotic-assisted partial nephrectomy performed by 1 of 11 surgeons at 6 large teaching hospitals', '48 patients randomized to the control group and 44 randomized to the intervention group']","['control group undergoing usual preoperative planning with computed tomography and/or magnetic resonance imaging only or an intervention group where imaging was supplemented with a 3-D VR model', '3-Dimensional Virtual Reality Models', 'robotic-assisted partial nephrectomy']","['estimated blood loss', 'clamp time', 'length of hospital stay', 'operative time', 'clamp time, estimated blood loss, and length of hospital stay', 'operative time, estimated blood loss, clamp time, and length of hospital stay']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy (procedure)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy (procedure)'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",92.0,0.171402,"This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay. ","[{'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Shirk', 'Affiliation': 'David Geffen School of Medicine, Department of Urology, University of California, Los Angeles.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Thiel', 'Affiliation': 'Department of Urology, Mayo Clinic Florida, Jacksonville.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Wallen', 'Affiliation': 'Chapel Hill School of Medicine, Department of Urology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Linehan', 'Affiliation': ""John Wayne Cancer Institute, Providence St John's Health Center, Santa Monica, California.""}, {'ForeName': 'Wesley M', 'Initials': 'WM', 'LastName': 'White', 'Affiliation': 'Department of Urology, The University of Tennessee Medical Center, Knoxville.'}, {'ForeName': 'Ketan K', 'Initials': 'KK', 'LastName': 'Badani', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Porter', 'Affiliation': 'Swedish Urology Group, Seattle, Washington.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11598'] 1504,28369278,Cytomegalovirus Urinary Shedding in HIV-infected Pregnant Women and Congenital Cytomegalovirus Infection.,"Background Cytomegalovirus (CMV) urinary shedding in pregnant women infected with human immunodeficiency virus (HIV) was evaluated to determine whether it poses an increased risk for congenital CMV infection (cCMV). Methods A subset of mother-infant pairs enrolled in the perinatal NICHD HPTN 040 study (distinguished by no antiretroviral use before labor) was evaluated. Maternal and infant urines were tested by qualitative real-time polymerase chain reaction (RT-PCR) for CMV DNA with quantitative RT-PCR performed on positive specimens. Results Urine specimens were available for 260 women with 85.4% from the Americas and 14.6% from South Africa. Twenty-four women (9.2%) had detectable CMV viruria by qualitative PCR. Maternal CMV viruria was not associated with mean CD4 cell counts or HIV viral load but was associated with younger maternal age (P = .02). Overall, 10 of 260 infants (3.8%) had cCMV. Women with detectable peripartum CMV viruria were more likely to have infants with cCMV than those without: 20.8% (5/24) versus 2.1% (5/236), (P = .0001). Women with CMV viruria had significantly higher rates of HIV perinatal transmission (29.2% vs. 8.1%, P = .002). They were 5 times (adjusted odds ratio [aOR] = 5.6, 95% confidence interval [CI] 1.9-16.8) and nearly 30 times (aOR, 29.7; 95% CI, 5.4-164.2) more likely to transmit HIV and CMV to their infants, respectively. Maternal gonorrhea (aOR, 19.5; 95% CI, 2.5-151.3) and higher maternal HIV log10 viral load (OR, 2.8; 95% CI, 1.3-6.3) were also significant risk factors for cCMV. Conclusion In this cohort of HIV-infected pregnant women not on antiretrovirals, urinary CMV shedding was a significant risk factor for CMV and HIV transmission to infants. Clinical Trials Registration Number NCT00099359.",2017,"Maternal gonorrhea (aOR, 19.5; 95% CI, 2.5-151.3) and higher maternal HIV log10 viral load (OR, 2.8; 95% CI, 1.3-6.3) were also significant risk factors for cCMV. ","['260 women with 85.4% from the Americas and 14.6% from South Africa', 'pregnant women infected with human immunodeficiency virus (HIV', 'A subset of mother-infant pairs enrolled in the perinatal NICHD HPTN 040 study (distinguished by no antiretroviral use before labor) was evaluated', 'HIV-infected Pregnant Women and Congenital Cytomegalovirus Infection']",[],"['cCMV', 'rates of HIV perinatal transmission', 'mean CD4 cell counts or HIV viral load', 'Cytomegalovirus Urinary Shedding', 'maternal HIV log10 viral load', 'Maternal CMV viruria', 'detectable CMV viruria by qualitative PCR', 'Maternal gonorrhea']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0158945', 'cui_str': 'Congenital cytomegalovirus infection (disorder)'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0042766', 'cui_str': 'Viruria (finding)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}]",260.0,0.292425,"Maternal gonorrhea (aOR, 19.5; 95% CI, 2.5-151.3) and higher maternal HIV log10 viral load (OR, 2.8; 95% CI, 1.3-6.3) were also significant risk factors for cCMV. ","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Adachi', 'Affiliation': 'David Geffen University of California, Los Angeles School of Medicine, Los Angeles, California.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Westat, Rockville, Maryland.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ank', 'Affiliation': 'David Geffen University of California, Los Angeles School of Medicine, Los Angeles, California.'}, {'ForeName': 'D Heather', 'Initials': 'DH', 'LastName': 'Watts', 'Affiliation': 'Office of the Global AIDS Coordinator, US Department of State, Washington, DC.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Mofenson', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jose Henrique', 'Initials': 'JH', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu.'}, {'ForeName': 'Esau', 'Initials': 'E', 'LastName': 'Joao', 'Affiliation': 'Hospital Federal dos Servidores do Estado, Rio de Janeiro.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Conceicao, Porto Alegre.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Hospital Femina, Porto Alegre.'}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Kreitchmann', 'Affiliation': 'Irmandade da Santa Casa de Misericordia de Porto Alegre, Rio Grande do Sul.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Minas Gerais, Belo Horizonte, Minas Gerais.'}, {'ForeName': 'Marisa M', 'Initials': 'MM', 'LastName': 'Mussi-Pinhata', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Brazil.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': 'SAMRC and Perinatal HIV Research Unit, University of Witwatersrand.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynecology, Stellenbosch University/Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Mariza G', 'Initials': 'MG', 'LastName': 'Morgado', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Yvonne J', 'Initials': 'YJ', 'LastName': 'Bryson', 'Affiliation': 'David Geffen University of California, Los Angeles School of Medicine, Los Angeles, California.'}, {'ForeName': 'Valdilea G', 'Initials': 'VG', 'LastName': 'Veloso', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Klausner', 'Affiliation': 'David Geffen University of California, Los Angeles School of Medicine, Los Angeles, California.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moye', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nielsen-Saines', 'Affiliation': 'David Geffen University of California, Los Angeles School of Medicine, Los Angeles, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/cix222'] 1505,32424045,C-reactive protein-guided antibiotic prescribing for COPD exacerbations: a qualitative evaluation.,"BACKGROUND Antibiotics are prescribed to >70% of patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The PACE randomised controlled trial found that a C-reactive protein point-of-care test (CRP-POCT) management strategy for AECOPD in primary care resulted in a 20% reduction in patient-reported antibiotic consumption over 4 weeks. AIM To understand perceptions of the value of CRP-POCT for guiding antibiotic prescribing for AECOPD; explore possible mechanisms, mediators, and pathways to effects; and identify potential barriers and facilitators to implementation from the perspectives of patients and clinicians. DESIGN AND SETTING Qualitative process evaluation in UK general practices. METHOD Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study. Interviews were audio-recorded, transcribed, and analysed using framework analysis. RESULTS Patients and clinicians felt that CRP-POCT was useful in guiding clinicians' antibiotic prescribing decisions for AECOPD, and were positive about introduction of the test in routine care. The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients. Some clinicians thought the CRP-POCT should be routinely used in consultations for AECOPD; others favoured use only when there was decisional uncertainty. CRP-POCT cartridge preparation time and cost were potential barriers to implementation. CONCLUSION CRP-POCT-guided antibiotic prescribing for AECOPD had high acceptability, but commissioning arrangements and further simplification of the CRP-POCT need attention to facilitate implementation in routine practice.",2020,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","['Qualitative process evaluation in UK general practices', 'COPD exacerbations', 'Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study', 'patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD']","['C-reactive protein point-of-care test (CRP-POCT', 'C-reactive protein-guided antibiotic prescribing']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],20.0,0.0494891,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","[{'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Singh-Mehta', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gal', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Melbye', 'Affiliation': 'General Practice Research Unit, Department of Community Medicine, UIT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""Population Health and Environment Sciences, King's College London, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X709865'] 1506,32424169,Aerobic exercise impacts the anterior cingulate cortex in adolescents with subthreshold mood syndromes: a randomized controlled trial study.,"Aerobic exercise is effective in alleviating mood symptoms while the mechanism is poorly understood. There are limited clinical trials that investigated the effect of exercise on the anterior cingulate cortex (ACC), a key brain region involved in mood regulations, in adolescents with subthreshold mood syndromes. This randomized controlled trial (RCT) of aerobic exercise was undertaken in a middle school in Guangzhou, China. Participants were adolescents aged 12-14 with subthreshold mood syndromes including depressive and manic symptoms and were randomly assigned to an aerobic exercise intervention or a psychoeducation control group. Participants in the exercise group received moderate-intensity exercise intervention, consisting of 30 mins running, 4 days per week for 3 months. The primary outcome in this study was structural changes in the ACC from baseline to post intervention. The trial was registered with ClinicalTrial.gov (NCT03300778). Of 56 participants who met the criteria for subthreshold mood syndromes, 39 (41.03% males) had complete MRI data, with 20 and 19 subjects in the exercise and control group, respectively. At baseline, demographic information (e.g., age and sex), clinical symptoms, and the gray matter volume and cortical thickness of ACC were matched between the two groups. After 12 weeks of treatment, participants in the exercise group displayed increased gray matter volume of the left rostral ACC (F 1,30  = 5.73, p = 0.02) and increased cortical thickness of the right rostral ACC (F 1,30  = 7.83, p = 0.01) when compared with the control group. No significant differences were found for caudal ACC cortical thickness and gray matter volume. Our data demonstrate that 12-week, moderate-intensity aerobic exercise can induce structural changes in the rostral ACC in adolescents with subthreshold mood syndromes.",2020,No significant differences were found for caudal ACC cortical thickness and gray matter volume.,"['adolescents with subthreshold mood syndromes', '56 participants who met the criteria for subthreshold mood syndromes, 39 (41.03% males) had complete MRI data, with 20 and 19 subjects in the exercise and control group, respectively', 'Participants were adolescents aged 12-14 with subthreshold mood syndromes including depressive and manic symptoms', 'middle school in Guangzhou, China']","['Aerobic exercise', 'moderate-intensity exercise intervention', 'aerobic exercise intervention or a psychoeducation control group', 'aerobic exercise']","['gray matter volume and cortical thickness of ACC', 'caudal ACC cortical thickness and gray matter volume', 'gray matter volume of the left rostral ACC', 'cortical thickness of the right rostral ACC']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",56.0,0.118219,No significant differences were found for caudal ACC cortical thickness and gray matter volume.,"[{'ForeName': 'Kangguang', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China. linkangguang@163.com.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stubbs', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Guangzhou Medical University (GuangzhouHuiai Hospital), Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Weicong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Academician workstation of Mood and Brain Sciences, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Academician workstation of Mood and Brain Sciences, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Guangzhou Medical University (GuangzhouHuiai Hospital), Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Yuanxuan Middle School, Huadu district, Guangzhou, China.'}, {'ForeName': 'Yanxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Mabel Ngai Kiu', 'Initials': 'MNK', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Runhua', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Bess Yin-Hung', 'Initials': 'BY', 'LastName': 'Lam', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. bess.lam@polyu.edu.hk.'}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}]",Translational psychiatry,['10.1038/s41398-020-0840-8'] 1507,20974645,"An open-label, randomized clinical trial assessing immunogenicity, safety and tolerability of pandemic influenza A/H1N1 MF59-adjuvanted vaccine administered sequentially or simultaneously with seasonal virosomal-adjuvanted influenza vaccine to paediatric kidney transplant recipients.","BACKGROUND The aim of this study was to investigate the immunogenicity, safety and tolerability of the 2009 A/H1N1 MF59-adjuvanted influenza vaccine, administered sequentially or simultaneously with the seasonal 2009-10 virosomal-adjuvanted influenza vaccine, to paediatric kidney transplant recipients. METHODS Thirty-two children and adolescents with transplanted kidneys and 32 age- and gender-matched healthy controls were randomized 1:1 to receive the pandemic vaccine upon enrolment and the seasonal vaccine 1 month later (16 transplant recipients and 16 healthy controls), or to receive the two vaccines simultaneously upon enrolment (16 transplant recipients and 16 healthy controls). RESULTS When the pandemic vaccine was administered sequentially to the seasonal vaccine, it was significantly less immunogenic in the patients than in the controls (P < 0.05); when it was administered together with the seasonal vaccine, the immune response of both patients (P < 0.05) and controls (P < 0.05) was significantly greater than when it was administered sequentially. Seroconversion rates and the geometric mean titres of all of the seasonal antigens were significantly lower in the patients, regardless of the type of vaccine administration (P < 0.05). Simultaneous administration was associated with a better immune response against A/H1N1 and A/H3N2 antigens in both patients and controls, and did not increase the mild local and systemic reactions. No impact on renal function was observed. CONCLUSIONS Paediatric kidney transplant recipients have a lower immune response to the pandemic influenza A/H1N1 MF59-adjuvanted and seasonal virosomal-adjuvanted influenza vaccines than healthy controls. The simultaneous administration of the two vaccines seems to increase immune response to both pandemic and seasonal A/H1N1 and A/H3N2 antigens, and has the same safety profile as that of the pandemic vaccine administered sequentially to the seasonal vaccine.",2011,"Simultaneous administration was associated with a better immune response against A/H1N1 and A/H3N2 antigens in both patients and controls, and did not increase the mild local and systemic reactions.","['paediatric kidney transplant recipients', '16 transplant recipients and 16 healthy controls', 'Thirty-two children and adolescents with transplanted kidneys and 32 age- and gender-matched healthy controls', 'Paediatric kidney transplant recipients']","['pandemic influenza A/H1N1 MF59-adjuvanted vaccine administered sequentially or simultaneously with seasonal virosomal-adjuvanted influenza vaccine', 'pandemic vaccine upon enrolment and the seasonal vaccine 1\xa0month later (16 transplant recipients and 16 healthy controls), or to receive the two vaccines simultaneously upon enrolment', 'H1N1 MF59-adjuvanted influenza vaccine, administered sequentially or simultaneously with the seasonal 2009-10 virosomal-adjuvanted influenza vaccine']","['mild local and systemic reactions', 'immunogenicity, safety and tolerability', 'Seroconversion rates and the geometric mean titres', 'renal function', 'immune response']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",32.0,0.0219477,"Simultaneous administration was associated with a better immune response against A/H1N1 and A/H3N2 antigens in both patients and controls, and did not increase the mild local and systemic reactions.","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': ""Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Meregalli', 'Affiliation': ''}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Daleno', 'Affiliation': ''}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Ghio', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Tagliabue', 'Affiliation': ''}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Valzano', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Galeone', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Edefonti', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Principi', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfq657'] 1508,31527093,Is faster better? A randomised crossover study comparing algorithms for closed-loop automatic oxygen control.,"OBJECTIVE Closed-loop automatic control (CLAC) of the fractional inspired oxygen (FiO 2 ) improved oxygen administration to preterm infants on respiratory support. We investigated whether a revised CLAC algorithm (CLAC fast , ≤2 FiO 2 adjustments/min), compared with routine manual control (RMC only ), increased the proportion of time with arterial haemoglobin oxygen saturation measured by pulse oximetry within prespecified target ranges (Target%) while not being inferior to the original algorithm (CLAC slow : ≤0.3 FiO 2 adjustments/min). DESIGN Unblinded randomised controlled crossover study comparing three modes of FiO 2 control in random order for 8 hours each: RMC supported by CLAC fast was compared with RMC only and RMC supported by CLAC slow . A computer-generated list of random numbers using a block size of six was used for the allocation sequence. SETTING Two German tertiary university neonatal intensive care units. PATIENTS Of 23 randomised patients, 19 were analysed (mean±SD gestational age 27±2 weeks; age at randomisation 24±10 days) on non-invasive (n=18) or invasive (n=1) respiratory support at FiO 2 >0.21. MAIN OUTCOME MEASURE Target%. RESULTS Mean±SD [95% CI] Target% was 68%±11% [65% to 71%] for CLAC fast versus 65%±11% [61% to 68%] for CLAC slow versus 58%±11% [55% to 62%] for RMC only . Prespecified hypothesis tests of: (A) superiority of CLAC fast versus RMC only and (B) non-inferiority of CLAC fast versus CLAC slow with margin of 5% yielded one-sided p values of <0.001 for both comparisons. CONCLUSIONS This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm. TRIAL REGISTRATION NUMBER NCT03163108.",2020,"This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm. ","['Two German tertiary university neonatal intensive care units', 'preterm infants on respiratory support', 'Of 23 randomised patients, 19 were analysed (mean±SD gestational age 27±2 weeks; age at randomisation 24±10 days) on non-invasive (n=18) or invasive (n=1) respiratory support at FiO 2 >0.21']","['closed-loop automatic oxygen control', 'Mean±SD', 'Closed-loop automatic control (CLAC) of the fractional inspired oxygen (FiO 2 ) improved oxygen administration']",['proportion of time with arterial haemoglobin oxygen saturation'],"[{'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C4517437', 'cui_str': '0.21 (qualifier value)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",,0.198641,"This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm. ","[{'ForeName': 'Christoph E', 'Initials': 'CE', 'LastName': 'Schwarz', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany C.Schwarz@med.uni-tuebingen.de.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kidszun', 'Affiliation': 'Department of Neonatology, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Bieder', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany.""}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany.""}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mildenberger', 'Affiliation': 'Department of Neonatology, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Seyfang', 'Affiliation': 'Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Urschitz', 'Affiliation': 'Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Mainz, Germany.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-317029'] 1509,32431211,Accurately Reflecting Uncertainty When Using Patient-Level Simulation Models to Extrapolate Clinical Trial Data.,"Introduction. Patient-level simulation models facilitate extrapolation of clinical trial data while allowing for heterogeneity, prior history, and nonlinearity. However, combining different types of uncertainty around within-trial and extrapolated results remains challenging. Methods. We tested 4 methods to combine parameter uncertainty (around the regression coefficients used to predict future events) with sampling uncertainty (uncertainty around mean risk factors within the finite sample whose outcomes are being predicted and the effect of treatment on these risk factors). We compared these 4 methods using a simulation study based on an economic evaluation extrapolating the AFORRD randomized controlled trial using the UK Prospective Diabetes Study Outcomes Model version 2. This established type 2 diabetes model predicts patient-level health outcomes and costs. Results. The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value). Allowing for sampling uncertainty as well as parameter uncertainty widened confidence intervals by 6.3-fold and gave 96.3% coverage. Methods adjusting for baseline risk factors that combine sampling and parameter uncertainty overcame the bias that can result from between-group baseline imbalance and gave confidence intervals around 50% wider than those just considering parameter uncertainty, with 99.8% coverage. Conclusions. Analyses extrapolating data for individual trial participants should include both sampling uncertainty and parameter uncertainty and should adjust for any imbalance in baseline covariates.",2020,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).",[],[],[],[],[],[],,0.0800414,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).","[{'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research & Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20916442'] 1510,31367916,Placebo therapy for cancer-related pain: an alternative to psychotherapy or health misinformation?,,2020,,['cancer-related pain'],['Placebo therapy'],[],"[{'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.106219,,"[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Braillon', 'Affiliation': 'University Hospital, 80000, Amiens, France. braillon.alain@gmail.com.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Ross', 'Affiliation': ', London, UK.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fisken', 'Affiliation': ', Berkshire, UK.'}, {'ForeName': 'Edzard', 'Initials': 'E', 'LastName': 'Ernst', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Colquhoun', 'Affiliation': 'University College London, London, UK.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05010-w'] 1511,31856947,"""Take Charge, Get Cured"": Pilot testing a targeted mHealth treatment decision support tool for methadone patients with hepatitis C virus for acceptability and promise of efficacy.","Hepatitis C (HCV) is a highly prevalent infection in current and former IV drug users. Current estimates indicate that over 70% of those in methadone maintenance treatment programs (MMTs) have HCV, but only 11% have initiated treatments despite availability of new treatments that are easily tolerated and can cure infection in about 8 weeks. We conducted a pilot randomized trial at four Philadelphia, PA MMTs to test acceptability, feasibility and promise of efficacy of our ""Take Charge, Get Cured"" mobile health (mHealth) treatment decision tool, developed through extensive formative work that included methadone patients' input and targeted directly to concerns of methadone patients with Hepatitis C (HCV). We compared its impact on perceptions and knowledge about HCV and HCV treatment, decisional conflict, intention to and actual initiation of HCV care to a web-based Cochrane-reviewed, non-targeted HCV decision tool. Subjects (n = 122) were randomized, administered baseline questionnaires, interacted with the targeted or non-targeted decision tool on an electronic tablet, and answered post-test questions. After 3-months subjects (n = 93; 76%) were surveyed for follow up. ""Take Charge, Get Cured"" users were more likely to report the tool helped with decision making and demonstrated greater improvement in knowledge, decisional conflict, and intention to be treated for their HCV infections than users of the non-targeted decision tool. They were significantly more likely to say the targeted tool was helpful and that they would recommend it to others. At three month follow up, targeted group participants were more likely to say the tool helped them make a better decision about treatment and prepared them to talk to their doctor about what matters most to them about treatment. No differences were seen in actions to initiate HCV care, but more targeted group participants reported talking to their doctors about HCV treatment. Results indicate a highly targeted mHealth decision tool is an important strategy to affect perceptions and knowledge of HCV treatment that lowers decisional conflict about initiating treatment, key components in decision making. We believe this highly acceptable and feasible intervention could be utilized in clinical settings to address the important barriers to initiating HCV treatment in a vulnerable population.",2020,"At three month follow up, targeted group participants were more likely to say the tool helped them make a better decision about treatment and prepared them to talk to their doctor about what matters most to them about treatment.","['patients with Hepatitis C (HCV', 'Subjects (n\u202f=\u202f122', 'methadone patients with hepatitis C']","['methadone', 'baseline questionnaires, interacted with the targeted or non-targeted decision tool on an electronic tablet, and answered post-test questions', 'Hepatitis C (HCV']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}]",[],,0.0431352,"At three month follow up, targeted group participants were more likely to say the tool helped them make a better decision about treatment and prepared them to talk to their doctor about what matters most to them about treatment.","[{'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Jessop', 'Affiliation': 'Western Michigan University, Public health Program, 200 Ionia Ave, NW, 4th Floor, Grand Rapids, MI 49503, USA; HepTREC, 141 Whitemarsh Rd, Ardmore, PA 19003, USA. Electronic address: amy.jessop@wmich.edu.'}, {'ForeName': 'Sarah Bauerle', 'Initials': 'SB', 'LastName': 'Bass', 'Affiliation': 'Temple University, Department of Social and Behavioral Sciences, Risk Communication Laboratory, College of Public Health, Ritter Annex, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Brajuha', 'Affiliation': 'Temple University, Department of Social and Behavioral Sciences, Risk Communication Laboratory, College of Public Health, Ritter Annex, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alhajji', 'Affiliation': 'Temple University, Department of Social and Behavioral Sciences, Risk Communication Laboratory, College of Public Health, Ritter Annex, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Burke', 'Affiliation': 'HepTREC, 141 Whitemarsh Rd, Ardmore, PA 19003, USA.'}, {'ForeName': 'Muhamed Tahar', 'Initials': 'MT', 'LastName': 'Gashat', 'Affiliation': 'HepTREC, 141 Whitemarsh Rd, Ardmore, PA 19003, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Wellington', 'Affiliation': 'Temple University, Department of Social and Behavioral Sciences, Risk Communication Laboratory, College of Public Health, Ritter Annex, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ventriglia', 'Affiliation': 'Temple University, Department of Social and Behavioral Sciences, Risk Communication Laboratory, College of Public Health, Ritter Annex, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Temple University, Department of Social and Behavioral Sciences, Risk Communication Laboratory, College of Public Health, Ritter Annex, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""D'Avanzo"", 'Affiliation': 'Temple University, Department of Social and Behavioral Sciences, Risk Communication Laboratory, College of Public Health, Ritter Annex, Philadelphia, PA 19122, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.11.001'] 1512,32431191,Topical tacrolimus with different frequency for exfoliative cheilitis: a pilot study.,"Background: Tacrolimus is a new type immunosuppressant. The aim of this study was to evaluate the effectiveness of topical tacrolimus 0.1% ointment at 2 different frequencies in treating patients with exfoliative cheilitis. Methods: A total of 40 patients with exfoliative cheilitis were randomly divided into the QD group receiving topical tacrolimus 0.1% ointment once a day or the QOD group receiving topical tacrolimus 0.1% ointment once-two-day. Patients were also applied wet dressing of saline twice a day. The effectiveness of treatment was defined as the percentage of improvement in signs or symptoms. Results: 37 patients completed the 2-week treatment. And, a full set was analyzed. The effectiveness of topical tacrolimus 0.1% ointment for relief in objective sign and subjective symptom was 50% and 67.5%% in the QD group, respectively. For the QOD group, the effectiveness of sign and symptom relief was 50% and 73.5%. There was no significant difference of effectiveness between application topical tacrolimus once a day and once 2 days. Conclusion: Our data suggested that application of topical tacrolimus 0.1% ointment once a day and once 2 days had similar clinical effectiveness for sign and symptom relief in patients with exfoliative cheilitis.",2020,"The effectiveness of topical tacrolimus 0.1% ointment for relief in objective sign and subjective symptom was 50% and 67.5%% in QD group, respectively.","['37 patients completed the 2-week treatment', 'exfoliative cheilitis', '40 patients with exfoliative cheilitis', 'patients with exfoliative cheilitis']","['Tacrolimus', 'topical tacrolimus 0.1% ointment once a day or QOD group receiving topical tacrolimus 0.1% ointment once-two-day', 'topical tacrolimus', 'Topical tacrolimus']","['objective sign and subjective symptom', 'effectiveness of sign and symptom relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0341058', 'cui_str': 'Exfoliative cheilitis'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0939241', 'cui_str': 'Tacrolimus-containing product in cutaneous dose form'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",40.0,0.0834622,"The effectiveness of topical tacrolimus 0.1% ointment for relief in objective sign and subjective symptom was 50% and 67.5%% in QD group, respectively.","[{'ForeName': 'Qian-Qian', 'Initials': 'QQ', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral Mucosal Diseases, Shangehai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""Department of Oral Mucosal Diseases, Shangehai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Department of Oral Mucosal Diseases, Shangehai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Liu', 'Affiliation': ""Department of Oral Mucosal Diseases, Shangehai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Jiang', 'Affiliation': ""Department of Oral Mucosal Diseases, Shangehai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1771258'] 1513,31856954,Postoperative opioid misuse in patients with opioid use disorders maintained on opioid agonist treatment.,"BACKGROUND Patients recovering from opioid use disorders (OUD) may be prone to relapse and opioid misuse in the postoperative period due to re-exposure to prescription opioids for pain control. This retrospective study analyzed the incidence of confirmed opioid misuse in the postoperative period in patients with OUDs enrolled in an opioid agonist treatment (OAT) program. METHODS The study population was US veterans with a diagnosis of OUD who enrolled in the OAT program at VA Maryland Health Care System (Baltimore, Maryland, USA) between 1/1/2000 and 12/31/2016. The patients were excluded if they were enrolled in OAT for less than a year, or if they had surgery within the first 180 days after OAT admission. The surgical group consisted of veterans who had surgery or an invasive procedure during their enrollment in the OAT program. The control (reference) group consisted of enrolled veterans who did not have any invasive procedure. The primary outcome was the first opioid misuse within 365 days after surgery date in the surgical group or a randomly assigned sham surgery date in controls. Opioid misuse was defined as either inappropriate use of opioids detected via urinalysis or admission with a diagnosis of an opioid overdose. RESULTS From a total of 1352 patients enrolled in the OAT program, 413 were excluded because they were enrolled for less than a year, and 26 were excluded because they had surgery within the first 180 days after admission to the OAT program. Of the 923 eligible patients, 87 had surgery while enrolled and 836 did not. Using propensity scores, all 87 of the surgical cases were matched to 249 of the control cases. In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p = 0.034) in logistic regression. CONCLUSION Among patients with a history of opioid use disorders, the postoperative period was associated with an increased risk of opioid misuse. Moreover, opioid misuse among patients in an opioid agonist treatment program may well be considered a surgical hazard.",2020,"In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p = 0.034) in logistic regression. ","['patients with a history of opioid use disorders', 'patients were excluded if they were enrolled in OAT for less than a year, or if they had surgery within the first 180 days after OAT admission', '923 eligible patients, 87 had surgery while enrolled and 836 did not', 'veterans who had surgery or an invasive procedure during their enrollment in the OAT program', 'enrolled veterans who did not have any invasive procedure', 'Patients recovering from opioid use disorders (OUD', '1352 patients enrolled in the OAT program, 413 were excluded because they were enrolled for less than a year, and 26 were excluded because they had surgery within the first 180\u202fdays after admission to the OAT program', 'patients with OUDs enrolled in an opioid agonist treatment (OAT) program', 'study population was US veterans with a diagnosis of OUD who enrolled in the OAT program at VA Maryland Health Care System (Baltimore, Maryland, USA) between 1/1/2000 and 12/31/2016', 'patients with opioid use disorders maintained on opioid agonist treatment']",[],"['postoperative opioid misuse', 'risk of opioid misuse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1352.0,0.0472194,"In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p = 0.034) in logistic regression. ","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America. Electronic address: Khodadad.namiranian@va.gov.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Norris', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'Minu', 'Initials': 'M', 'LastName': 'Aghevli', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Covington', 'Affiliation': 'Neurological Institute (Emeritus), Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.10.007'] 1514,32430167,Gamification in rehabilitation of metacarpal fracture using cost-effective end-user device: A randomized controlled trial.,"STUDY DESIGN This is a two-group randomized controlled trial. INTRODUCTION Finger stiffness after treatment for metacarpal fractures often occurs due to poor compliance to the conventional rehabilitation programs. Gamification has shown success in improving adherence to and effectiveness of various therapies. PURPOSE OF THE STUDY The purpose of this study was to evaluate whether gamification, using cost-effective devices was comparable with conventional physiotherapy in improving hand functions and adherence to rehabilitation in metacarpal fractures. METHODS A 2-group randomized controlled trial involving 19 patients was conducted. Participants were randomized to a control (conventional physiotherapy, n = 10) or interventional group (gamification, n = 9). The grips strength and composite finger range of motion were measured at the baseline and each follow-up together with Patient-Rated Wrist and Hand Evaluation scores and compliance. RESULTS There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886). However, the gamification group showed better results in Patient-Rated Wrist and Hand Evaluation (mean 0.44 vs 8.45, P = .038) and compliance (P < .05). No adverse events were reported. DISCUSSION Our results suggest that gamification using a cost-effective device demonstrated similar effectiveness as conventional physiotherapy in post-metacarpal fracture rehabilitation. CONCLUSIONS Gamification using a mobile device is an inexpensive and safe alternative to conventional physiotherapy for hand rehabilitation after metacarpal fractures. It effectively serves as a guide for future development of cost-effective technology-enhanced therapy.",2020,"There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886).",['19 patients was conducted'],"['conventional physiotherapy', 'control (conventional physiotherapy, n\xa0=\xa010) or interventional group (gamification, n\xa0=\xa09']","['Patient-Rated Wrist and Hand Evaluation', 'composite finger range of motion', 'grip strength', 'adverse events', 'grips strength and composite finger range of motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0575830', 'cui_str': 'Finger joint - range of movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",19.0,0.0811644,"There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886).","[{'ForeName': 'Jun Wei', 'Initials': 'JW', 'LastName': 'Then', 'Affiliation': 'Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia. Electronic address: drjwthen_1004@yahoo.com.my.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Shivdas', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tunku Sara', 'Initials': 'TS', 'LastName': 'Tunku Ahmad Yahaya', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nor Izzati', 'Initials': 'NI', 'LastName': 'Ab Razak', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Pee Terh', 'Initials': 'PT', 'LastName': 'Choo', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.029'] 1515,32430896,Correction to: Endoscopic Argon Plasma Coagulation Vs. Multidisciplinary Evaluation in the Management of Weight Regain after Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,In the original article the captions for Figs. 1-3 are incorrect.,2020,1-3 are incorrect.,['after Gastric Bypass Surgery'],"['SHAM', 'Endoscopic Argon Plasma Coagulation Vs']",['Weight Regain'],"[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.102734,1-3 are incorrect.,"[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04478-4'] 1516,31433930,Fornix-Region Deep Brain Stimulation-Induced Memory Flashbacks in Alzheimer's Disease.,,2019,,"[""Alzheimer's Disease""]",['Fornix-Region Deep Brain Stimulation-Induced Memory Flashbacks'],[],"[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0152334', 'cui_str': 'Cerebral fornix structure'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks (disorder)'}]",[],,0.0516592,,"[{'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Deeb', 'Affiliation': 'University of Florida, Gainesville, FL wissam.deeb@neurology.ufl.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Salvato', 'Affiliation': 'Florida State University, Tallahassee, FL.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Almeida', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Foote', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Amaral', 'Affiliation': 'Douglas Mental Health University Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Germann', 'Affiliation': 'Douglas Mental Health University Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Tang-Wai', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Burke', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Salloway', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Marwan N', 'Initials': 'MN', 'LastName': 'Sabbagh', 'Affiliation': 'Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV.'}, {'ForeName': 'M Mallar', 'Initials': 'MM', 'LastName': 'Chakravarty', 'Affiliation': 'Douglas Mental Health University Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Gwenn S', 'Initials': 'GS', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Constantine G', 'Initials': 'CG', 'LastName': 'Lyketsos', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Lozano', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'University of Florida, Gainesville, FL.'}]",The New England journal of medicine,['10.1056/NEJMc1905240'] 1517,31916678,"Specificity, Dose Dependency, and Kinetics of Markers of Chicken and Beef Intake Using Targeted Quantitative LC-MS/MS: A Human Intervention Trial.","SCOPE Common methods for food intake assessment are error-prone. Estimating food intake via metabolite biomarkers in blood/urine is challenged by inter-individual variation. Here, meat intake markers based on criteria defined within the FoodBAll consortium, including dose dependency, specificity, kinetics, and their ability to predict meat dose, are evaluated. METHODS AND RESULTS In two randomized human interventions, meat at different doses are consumed. Plasma concentrations of 100 analytes, including previously proposed meat intake markers, are determined at different time points up to 24 h after meat ingestion using targeted liquid chromatography-tandem mass spectrometry. Plasma concentrations of π-methylhistidine (π-M-His) correlated best with the chicken meat amount consumed even after 24 h (R 2 = 0.96). Both, anserine and π-M-His show first-order elimination kinetics, irrespective of meat dose (t 1/2 is 1.4 and 5.9 h, respectively). Surprisingly, π-M-His best predicted the amount of beef consumed, albeit at lower concentrations. Furthermore, trimethylamine-N-oxide (TMAO) increases only after beef, while dimethylglycine only after chicken consumption. The lack of baseline concentrations for π-M-His and anserine is likely the strength of these compounds to predict meat dose. CONCLUSION Quantitative assessment of meat intake within 24 h is most accurate with π-M-His, whereas TMAO and dimethylglycine best discriminate between chicken and beef.",2020,Plasma concentrations of π-methylhistidine correlated best with the amount of chicken meat consumed even after 24h (R 2 = 0.96).,[],[],"['Specificity, Dose Dependency, and Kinetics of Markers of Chicken and Beef Intake', 'Plasma concentrations', 'Plasma concentrations of π-methylhistidine', 'TMAO']",[],[],"[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus domesticus'}, {'cui': 'C0556203', 'cui_str': 'Beef intake (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025780', 'cui_str': 'Methylhistidines'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}]",,0.0388879,Plasma concentrations of π-methylhistidine correlated best with the amount of chicken meat consumed even after 24h (R 2 = 0.96).,"[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Giesbertz', 'Affiliation': 'Department of Nutritional Physiology, Technical University of Munich, 85354, Freising, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Brandl', 'Affiliation': 'ZIEL Institute for Food and Health, Technical University of Munich, 85354, Freising, Germany.'}, {'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Else Kröner-Fresenius-Center of Nutritional Medicine, Technical University of Munich, 85354, Freising, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hauner', 'Affiliation': 'ZIEL Institute for Food and Health, Technical University of Munich, 85354, Freising, Germany.'}, {'ForeName': 'Hannelore', 'Initials': 'H', 'LastName': 'Daniel', 'Affiliation': 'Department of Nutritional Physiology, Technical University of Munich, 85354, Freising, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Skurk', 'Affiliation': 'ZIEL Institute for Food and Health, Technical University of Munich, 85354, Freising, Germany.'}]",Molecular nutrition & food research,['10.1002/mnfr.201900921'] 1518,32127212,"Re: Electromagnetic Low-intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-controlled, Double-blind, Randomized Prospective Study.",,2020,,['Patients with Erectile Dysfunction'],['Re: Electromagnetic Low-intensity Extracorporeal Shock Wave Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]",[],,0.308369,,"[{'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kałka', 'Affiliation': 'Cardiosexology Unit, Department of Pathophysiology, Wrocław Medical University, Wrocław, Poland; Mens Heath Centre, Wrocław, Poland. Electronic address: dariusz.kalka@gmail.com.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Gebala', 'Affiliation': 'Cardiosexology Students Club, Wrocław Medical University, Wrocław, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Biernikiewicz', 'Affiliation': 'Studio Słowa, Wrocław, Poland.'}]",European urology,['10.1016/j.eururo.2020.02.018'] 1519,31557777,[French comment on article Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial].,,2019,,['high risk patients'],['pancreatic duct stenting plus pharmacological prophylaxis'],[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure (body structure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]",[],,0.0225803,,[],Endoscopy,['10.1055/a-1000-5840'] 1520,32432326,"Intrauterine insemination performance characteristics and post-processing total motile sperm count in relation to live birth for couples with unexplained infertility in a randomised, multicentre clinical trial.","STUDY QUESTION Are intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC) related to live birth rate in couples with unexplained infertility? SUMMARY ANSWER Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success. WHAT IS ALREADY KNOWN We previously determined that some baseline characteristics of couples with unexplained infertility, including female age, duration of infertility, history of prior loss and income, were related to live birth rate across a course of ovarian stimulation and IUI treatment. However, the relationship between treatment outcomes and per-cycle characteristics, including ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC, are controversial, and most prior investigations have not evaluated live birth outcome. STUDY DESIGN, SIZE, DURATION This was a secondary analyses of 2462 cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. This prospective, randomised, multicentre clinical trial determined live birth rates following IUI after ovarian stimulation with clomiphene citrate, letrozole or gonadotropins in 854 couples with unexplained infertility. It was conducted between 2011 and 2014, and couples could undergo up to four consecutive treatment cycles. PARTICIPANTS/MATERIALS, SETTING, METHODS AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites. Participants were women with unexplained infertility who were between 18 and 40 years of age. Cluster-weighted generalised estimating equations (GEE), which account for informative clustering of multiple IUI treatment cycles within the same patient, were used to determine associations between IUI performance characteristics, including inseminate TMC, and live birth rate. Efficiency curves were also generated to examine the relationship between inseminate TMC and live birth rate. MAIN RESULTS AND THE ROLE OF CHANCE After adjustment for treatment group and baseline factors previously associated with live birth across a course of OS-IUI treatment, patient discomfort during the IUI procedure was associated with a reduction in live birth rate (aRR 0.40 (0.16-0.96)). Time from hCG trigger injection to IUI was not significantly associated with outcome. Higher TMC was associated with greater live birth rate (TMC 15.1-20.0 million (14.8%) compared to ≤5 million (5.5%)) (aRR 2.09 (1.31-3.33)). However, live births did occur with TMC ≤ 1 million (5.1%). LIMITATIONS, REASONS FOR CAUTION This investigation is a secondary analysis, and AMIGOS was not designed to address the present question. Since timed intercourse was allowed as part of the AMIGOS trial, we cannot rule out the possibility that any given pregnancy resulted from intercourse rather than IUI. WIDER IMPLICATIONS OF THE FINDINGS Most factors associated with the performance of IUI were not significantly related to obtaining live birth. Our findings suggest that higher TMC inseminated leads to an increase in live birth rate up to TMC ~20 million. However, there may be no reasonable threshold below which live birth is not possible with IUI. STUDY FUNDING/COMPETING INTEREST(S) Funding was received through grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): U10 HD077680, U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936 and U10 HD055925. This research was made possible by funding by the American Recovery and Reinvestment Act. Dr Hansen reports grants from NIH/NICHD and Yale University during the conduct of the study, grants from Roche Diagnostics and grants from Ferring International Pharmascience Center US outside the submitted work. Dr Peck reports support from Ferring Pharmaceuticals outside the submitted work. Dr Coward has nothing to disclose. Dr Wild reports grants from NICHD during the conduct of the study. Dr Trussell has nothing to disclose. Dr Krawetz reports grants from NICHD during the conduct of the study, grants from Merck and support from Taylor and Frances and from Springer, outside the submitted work. Dr Diamond reports grants from NIH/NICHD, Yale University, during the conduct of the study and support from Advanced Reproductive Care AbbVie, Bayer and ObsEva, outside the submitted work. Dr Legro reports support from Bayer, Kindex, Odega, Millendo and AbbVie and grants and support from Ferring, outside the submitted work. Dr Coutifaris reports grants from NICHD/NIH and personal fees from American Society for Reproductive Medicine, outside the submitted work. Dr Alvero has nothing to disclose. Dr Robinson reports grants from NIH during the conduct of the study. Dr Casson has nothing to disclose. Dr Christman reports grants from NICHD during the conduct of the study. Dr Santoro reports grants from NIH during the conduct of the study. Dr Zhang reports grants from NIH during the conduct of the study and support from Shangdong University outside the submitted work. TRIAL REGISTRATION NUMBER n/a.",2020,"SUMMARY ANSWER Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success. ","['Participants were women with unexplained infertility who were between 18 and 40\xa0years of age', 'AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites', '854 couples with unexplained infertility', '2462\xa0cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial', '2011 and 2014, and couples could undergo up to four consecutive treatment cycles', 'couples with unexplained infertility']","['intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC', 'clomiphene citrate, letrozole or gonadotropins', 'Intrauterine insemination performance characteristics and post-processing total motile sperm count']","['live birth across a course of OS-IUI treatment, patient discomfort', 'live birth rate', 'ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0242668', 'cui_str': 'Medicine, Reproductive'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0449935', 'cui_str': 'Post-processing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",854.0,0.111279,"SUMMARY ANSWER Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success. ","[{'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peck', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, UNC School of Medicine, 2113 Physicians Office Building CB#7235, Chapel Hill, NC 27599-7235, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trussell', 'Affiliation': 'Department of Urology, Upstate University Hospital, 750 East Adams Street, Syracuse, NY 13210, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology and Molecular Medicine and Genetics, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, PA 17033, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Randal D', 'Initials': 'RD', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, TX 78229, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, VT 05446, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06520, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa027'] 1521,29657029,The Hormone FGF21 Stimulates Water Drinking in Response to Ketogenic Diet and Alcohol.,"Alcohol and ketogenic diets increase water consumption. Here, we show that the hormone FGF21 is required for this drinking response in mice. Circulating levels of FGF21 are increased by alcohol consumption in humans and by both alcohol and ketogenic diets in mice. Pharmacologic administration of FGF21 stimulates water drinking behavior in mice within 2 hr. Concordantly, mice lacking FGF21 fail to increase water intake in response to either alcohol or a ketogenic diet. The effect of FGF21 on drinking is mediated in part by SIM1-positive neurons of the hypothalamus and is inhibited by β-adrenergic receptor antagonists. Given that FGF21 also is known to suppress alcohol intake in favor of pure water, this work identifies FGF21 as a fundamental neurotropic hormone that governs water balance in response to specific nutrient stresses that can cause dehydration.",2018,"Concordantly, mice lacking FGF21 fail to increase water intake in response to either alcohol or a ketogenic diet.",[],"['FGF21', 'Alcohol and ketogenic diets']",[],[],"[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}]",[],,0.0118931,"Concordantly, mice lacking FGF21 fail to increase water intake in response to either alcohol or a ketogenic diet.","[{'ForeName': 'Parkyong', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zechner', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Genaro', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cánovas', 'Affiliation': 'Departments of Biochemistry and Molecular Biophysics and Neuroscience, Columbia College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Sondhi', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stadlbauer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Department of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria; Center for Biomarker Research in Medicine (CBmed), 8010 Graz, Austria.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Department of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria; Center for Biomarker Research in Medicine (CBmed), 8010 Graz, Austria.'}, {'ForeName': 'Ming Chang', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Orson W', 'Initials': 'OW', 'LastName': 'Moe', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Physiology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mangelsdorf', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Howard Hughes Medical Institute, UT Southwestern Medical Center, Dallas, TX 75390, USA. Electronic address: davo.mango@utsouthwestern.edu.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kliewer', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Molecular Biology, UT Southwestern Medical Center, Dallas, TX 75390, USA. Electronic address: steven.kliewer@utsouthwestern.edu.'}]",Cell metabolism,['10.1016/j.cmet.2018.04.001'] 1522,32432795,"The effect of mindfulness-based training on stress, anxiety, depression and job satisfaction among ward nurses: A randomized control trial.","AIM To assess the effect of a 4-week mindfulness-based training intervention on improving stress, anxiety, depression and job satisfaction among ward nurses. BACKGROUND Previous literature showed that mindfulness-based training is useful for helping nurses cope with stress. METHOD Nurses who have mild to moderate levels of stress, anxiety and depression identified from a teaching hospital were invited to a randomized control trial. The intervention group had a 2-hr Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website. Both the intervention group (n = 118) and the control group (n = 106) were evaluated pre- and post-intervention, and 8 weeks later (follow-up) using the Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale and Mindful Attention Awareness Scale. RESULTS There was a significant effect over time on stress, anxiety, depression and mindfulness level (p < .05). Regarding the difference between the groups and interaction between time and group, there was a significant effect for anxiety (p = .037 p = .008) and job satisfaction (p < .001, p = .40), respectively, with moderate effect size for anxiety reduction (.465) and small for job satisfaction increment (.221). CONCLUSION Mindfulness-Based Training is effective in improving anxiety and job satisfaction among nurses. CLINICAL IMPLICATIONS FOR NURSING MANAGEMENT Mindfulness-Based Training can be included as hospital policy to reduce anxiety and increase job satisfaction among nurses.",2020,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","['Nurses who have mild to moderate levels of stress, anxiety, and depression identified from a teaching hospital', 'Among Ward Nurses']","['Mindfulness-Based Training', '4-week Mindfulness-Based Training intervention', '2-hour Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website', 'mindfulness training']","['stress, anxiety, depression and mindful level (p˂.05', 'anxiety', 'anxiety and job satisfaction', 'Stress, Anxiety, Depression, and Job Satisfaction', 'anxiety reduction', 'Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale, and Mindful Attention Awareness Scale', 'job satisfaction', 'stress, anxiety, depression, and job satisfaction']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0175315,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","[{'ForeName': 'Sajed Faisal', 'Initials': 'SF', 'LastName': 'Ghawadra', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Khatijah', 'Initials': 'K', 'LastName': 'Lim Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan Yuen', 'Initials': 'WY', 'LastName': 'Choo', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Danaee', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Cheng Kar', 'Initials': 'CK', 'LastName': 'Phang', 'Affiliation': 'Behavioral Health Centre, Sunway Medical Centre, Selangor, Malaysia.'}]",Journal of nursing management,['10.1111/jonm.13049'] 1523,32428648,Hickman Central Venous Catheters in Children: Open Versus Percutaneous Technique.,"BACKGROUND The ideal technique for insertion of tunneled central venous catheters (CVCs) in children is still debatable. This study aimed to compare the outcomes of open versus percutaneous technique for the insertion of tunneled CVCs. METHODS The study included 279 patients who had CVCs insertions from 2010 to 2020. Patients were divided into two groups according to the technique of insertion: group 1 (n = 90) included patients who had the open cutdown method and group 2 (n = 189) included patients who had the percutaneous technique. RESULTS There was no difference in age and gender distribution between groups (P = 0.152 and 0.102, respectively). Chemotherapy was the most common indication of insertion (77 [85.56%] vs. 165 [87.30%]); in group 1 vs. 2, P = 0.688). The left external jugular was the most common site of insertion in group 1 (n = 66; 73.33%), and the left subclavian was the most common site in group 2 (n = 77; 40.74%). Complications of insertion were nonsignificantly higher in group 2 (P = 0.170). Nine patients in group 2 required conversion to cutdown technique (4.76%). Complications during removal were nonsignificantly higher in group 2 (P = 0.182), and the most common was bleeding (n = 4; 2.12%). The most common indication for catheter removal was the completion of the treatment (36 [40%] vs. 85 [44.97%] in groups 1 and 2, respectively). CONCLUSIONS Percutaneous and open tunneled central venous catheter insertion are safe in pediatric patients who require long-term venous access. Both techniques have a low complication rate. The choice of each method should be tailored to the condition of each patient.",2020,Complications during removal were non-significantly higher in group 2 (p= 0.182) and the most common was bleeding (n= 4; 2.12%).,"['279 patients who had CVCs insertions from 2010 to 2020', 'Patients were divided into two groups according to the technique of insertion; group 1 (n= 90) included patients who had the open cut-down method, and group 2 (n= 189) included patients who had the percutaneous technique', 'pediatric patients who require long-term venous access', 'children']","['tunneled central venous catheters (CVCs', 'Percutaneous and open tunneled central venous catheter insertion', 'Chemotherapy', 'Hickman central venous catheters', 'open versus percutaneous technique', 'percutaneous technique']","['Complications during removal', 'conversion to cut-down technique', 'catheter removal', 'Complications of insertion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0457431', 'cui_str': 'Percutaneous techniques'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0457431', 'cui_str': 'Percutaneous techniques'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",279.0,0.0687854,Complications during removal were non-significantly higher in group 2 (p= 0.182) and the most common was bleeding (n= 4; 2.12%).,"[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Bawazir', 'Affiliation': 'Pediatric Surgery and Pediatric Urology, Department of Surgery, Faculty of Medicine in Umm Al-Qura University at Makkah, Makkah, Saudi Arabia; King Faisal Specialist Hospital & Research Centre, Department of Surgery, Jeddah, Saudi Arabia. Electronic address: obawazir@yahoo.com.'}, {'ForeName': 'Tariq I', 'Initials': 'TI', 'LastName': 'Altokhais', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, College of Medicine and King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.04.059'] 1524,31556399,Secondary re-analysis of the FEAST trial.,,2019,,[],[],[],[],[],[],,0.165992,,"[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Quartagno', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London WC1V 6LJ, UK. Electronic address: m.quartagno@ucl.ac.uk.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'De Stavola', 'Affiliation': 'Great Ormond Street Institute of Child Health, Faculty of Population Health Sciences, University College London, London WC1V 6LJ, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Carpenter', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London WC1V 6LJ, UK; Medical Statistics Department, London School of Hygiene and Tropical Medicine, London, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30270-X'] 1525,31556400,Secondary re-analysis of the FEAST trial - Authors' reply.,,2019,,[],[],[],[],[],[],,0.1196,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levin', 'Affiliation': 'Section of Paediatric Infectious Diseases, Department of Infectious Disease, Imperial College London, London W2 1PG, UK. Electronic address: m.levin@imperial.ac.uk.'}, {'ForeName': 'Aubrey J', 'Initials': 'AJ', 'LastName': 'Cunnington', 'Affiliation': 'Section of Paediatric Infectious Diseases, Department of Infectious Disease, Imperial College London, London W2 1PG, UK.'}, {'ForeName': 'Clive J', 'Initials': 'CJ', 'LastName': 'Hoggart', 'Affiliation': 'Section of Paediatric Infectious Diseases, Department of Infectious Disease, Imperial College London, London W2 1PG, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30264-4'] 1526,31556398,Secondary re-analysis of the FEAST trial.,,2019,,[],[],[],[],[],[],,0.165992,,"[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Maitland', 'Affiliation': ""Department of Medicine, Imperial College London, St Mary's Campus, London W2 1PG, UK. Electronic address: k.maitland@imperial.ac.uk.""}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Babiker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30272-3'] 1527,31801164,"[Strategies to Recruit Refugees for Intervention Studies: Lessons Learned from the ""Sanadak"" Trial].","OBJECTIVE Recruitment of so called rare populations, including refugees, for participation in research studies is challenging. We aim to share our lessons learned regarding recruitment strategies used in the ""Sanadak"" trial, a randomized controlled trial for the evaluation of a self-help app for Syrian refugees with posttraumatic stress. METHODS We conducted an interim evaluation of our recruitment strategies. A quantitative analysis addressed how potential study participants first learned about ""Sanadak"" and in which way they made first contact with us. A qualitative part included problem-centered interviews with our Syrian study nurses (n=3) regarding the success of various recruitment strategies and perceived barriers. RESULTS Data were available for the recruitment of 140 Syrian refugees. Almost half of the sample (44%) was recruited via personal contact, about another third (36%) by means of study promotion (e. g. Facebook ads), and about a fifth (19%) through multipliers. Typical barriers were concerns regarding data protection, anonymity and stigmatization. DISCUSSION Snowball sampling was an effective recruitment strategy in our trial. This is also the most acknowledged recruitment strategy for rare populations. In addition, other strategies were useful to increase sample variance. The interim evaluation helped to direct efforts towards effective recruitment strategies and to identify and address barriers. CONCLUSION Multi-strategic recruitment with a focus on snowball sampling, multiple options to make contact with the study team, and having culturally sensitive members in the study team contributed towards successful recruitment in the ""Sanadak""-trial.",2019,"A quantitative analysis addressed how potential study participants first learned about ""Sanadak"" and in which way they made first contact with us.",[],[],[],[],[],[],,0.165927,"A quantitative analysis addressed how potential study participants first learned about ""Sanadak"" and in which way they made first contact with us.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Roehr', 'Affiliation': 'Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Universität Leipzig, Leipzig.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Wittmann', 'Affiliation': 'Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Universität Leipzig, Leipzig.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Jung', 'Affiliation': 'Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Universität Leipzig, Leipzig.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Hoffmann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters, Medizinische Fakultät, Universität Leipzig, Leipzig.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig, Leipzig.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Institut für Gesundheitsökonomie und Versorgungsforschung, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Hamburg.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grochtdreis', 'Affiliation': 'Institut für Gesundheitsökonomie und Versorgungsforschung, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Hamburg.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Kersting', 'Affiliation': 'Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig, Leipzig.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Institut für Gesundheitsökonomie und Versorgungsforschung, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Hamburg.'}, {'ForeName': 'Steffi G', 'Initials': 'SG', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Universität Leipzig, Leipzig.'}]","Psychotherapie, Psychosomatik, medizinische Psychologie",['10.1055/a-1030-4570'] 1528,31839873,Using Adaptive Designs to Avoid Selecting the Wrong Arms in Multiarm Comparative Effectiveness Trials.,"Limited resources are a challenge when planning comparative effectiveness studies of multiple promising treatments, often prompting study planners to reduce the sample size to meet the financial constraints. The practical solution is often to increase the efficiency of this sample size by selecting a pair of treatments among the pool of promising treatments before the clinical trial begins. The problem with this approach is that the investigator may inadvertently leave out the most beneficial treatment. This paper demonstrates a possible solution to this problem by using Bayesian adaptive designs. We use a planned comparative effectiveness clinical trial of treatments for sialorrhea in amyotrophic lateral sclerosis as an example of the approach. Rather than having to guess at the two best treatments to compare based on limited data, we suggest putting more arms in the trial and letting response adaptive randomization (RAR) determine better arms. To ground this study relative to previous literature we first compare RAR, adaptive equal randomization (ER), arm(s) dropping, and a fixed design. Given the goals of this trial we demonstrate that we may avoid 'type III errors' - inadvertently leaving out the best treatment - with little loss in power compared to a two-arm design, even when choosing the correct two arms for the two-armed design. There are appreciable gains in power when the two arms are prescreened at random.",2019,"Given the goals of this trial we demonstrate that we may avoid 'type III errors' - inadvertently leaving out the best treatment - with little loss in power compared to a two-arm design, even when choosing the correct two arms for the two-armed design.",[],[],[],[],[],[],,0.0742287,"Given the goals of this trial we demonstrate that we may avoid 'type III errors' - inadvertently leaving out the best treatment - with little loss in power compared to a two-arm design, even when choosing the correct two arms for the two-armed design.","[{'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS 66160, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Statland', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Mail Stop 2012, 3901 Rainbow Blvd., Kansas City, KS 66160, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Mail Stop 2012, 3901 Rainbow Blvd., Kansas City, KS 66160, USA.'}]",Statistics in biopharmaceutical research,['10.1080/19466315.2019.1610044'] 1529,32007609,"An Invited Commentary on ""Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus"" (Int J Surg 2020; 74:81-5).",,2020,,[],['endoscopic versus conventional treatment of pilonidal sinus'],[],[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}]",[],,0.0178456,,"[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Crocetti', 'Affiliation': 'Department of Surgery ""P. Valdoni"", Sapienza University of Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Cavallaro', 'Affiliation': 'Department of Surgery ""P. Valdoni"", Sapienza University of Rome, Italy. Electronic address: giuseppe.cavallaro@uniroma1.it.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.01.132'] 1530,17435976,[Preoperative administration of angiotensin-converting enzyme inhibitors].,"INTRODUCTION The discussion about perioperative withdrawal or continuation of angiotensin-converting enzyme inhibitors (ACEI) remains controversial. Should it be continued to avoid peaks in blood pressure and heart rate during anesthesia? Or should it be discontinued the day before to avoid clinically relevant hypotonia? What is the greater risk? Since there are only a few studies dealing with this question, we compared the cardio-circulatory reaction during anesthesia after withdrawal and with continuation of ACEI therapy. METHODS A total of 100 hypertonic patients chronically treated with ACEIs were included in this prospective, randomized, double blind study. The last ACEI medication was given with the premedication in the morning (premed) or on the day before (withdrawal). Blood pressure and heart rate during induction and termination of anesthesia were compared between both groups. A threshold value for vasopressor therapy was determined to be a mean arterial pressure of 60 mmHg. RESULTS In the premed group Akrinor was necessary significantly more often and in higher dosages. Nevertheless, following induction the blood pressure and heart rates were significantly lower compared to the withdrawal group. The highest blood pressure and heart rate during induction and termination of anesthesia did not differ between the groups. CONCLUSIONS The continuation of ACEI therapy in the morning is not associated with a better control of blood pressure and heart rate but causes a more pronounced hypotension which forced a therapy more often. Patients chronically treated with ACEI should receive the ACEI the last time on the day before the operation and not with the premedication in the morning.",2007,The continuation of ACEI therapy in the morning is not associated with a better control of blood pressure and heart rate but causes a more pronounced hypotension which forced a therapy more often.,['100 hypertonic patients chronically treated with ACEIs'],"['angiotensin-converting enzyme inhibitors (ACEI', 'ACEI', 'angiotensin-converting enzyme inhibitors']","['blood pressure and heart rates', 'Blood pressure and heart rate', 'highest blood pressure and heart rate during induction and termination of anesthesia', 'blood pressure and heart rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",100.0,0.0417535,The continuation of ACEI therapy in the morning is not associated with a better control of blood pressure and heart rate but causes a more pronounced hypotension which forced a therapy more often.,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schirmer', 'Affiliation': 'Abteilung Kardioanästhesiologie, Universitätsklinikum Ulm, Steinhövelstr. 9, 89075, Ulm. uwe.schirmer@uniklinik-ulm.de'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Schürmann', 'Affiliation': ''}]",Der Anaesthesist,[] 1531,32430458,Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial.,"OBJECTIVE To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in children and adolescents (6-17 years old) with type 1 diabetes. RESEARCH DESIGN AND METHODS EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90-130 mg/dL (5.0-7.2 mmol/L), with continuation of prior prandial insulin. The primary end point was change in HbA 1c from baseline to week 26. Other assessments included change in fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events. RESULTS In 463 randomized participants (Gla-300, n = 233; Gla-100, n = 230), comparable least squares (LS) mean (SE) reductions in HbA 1c were observed from baseline to week 26 (-0.40% [0.06%] for both groups), with LS mean between-group difference of 0.004% (95% CI -0.17 to 0.18), confirming noninferiority at the prespecified 0.3% (3.3 mmol/mol) margin. Mean FPG change from baseline to week 26 was also similar between groups. During the 6-month treatment period, incidence and event rates of severe or documented (≤70 mg/dL [≤3.9 mmol/L]) hypoglycemia were similar between groups. Incidence of severe hypoglycemia was 6.0% with Gla-300 and 8.8% with Gla-100 (relative risk 0.68 [95% CI 0.35-1.30]). Incidence of any hyperglycemia with ketosis was 6.4% with Gla-300 and 11.8% with Gla-100. CONCLUSIONS Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.",2020,"Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.","['With Type 1 Diabetes', 'children and adolescents (6-17 years old) with type 1 diabetes', 'Children and Adolescents (6-17 years', 'children and adolescents with type 1 diabetes']","['insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100', 'Gla-300', 'Insulin Glargine 300 Units/mL', 'Insulin Glargine 100 Units/mL (Gla-100', 'Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90-130 mg/dL']","['Efficacy and Safety', 'Mean FPG change', 'change in HbA 1c', 'fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events', 'incidence and event rates of severe', 'Incidence of severe hypoglycemia', 'Incidence of any hyperglycemia with ketosis', 'hypoglycemia', 'efficacy and safety']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",463.0,0.0547279,"Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital AUF DER BULT, Hannover Medical School, Hannover, Germany danne@hka.de.""}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Oleg A', 'Initials': 'OA', 'LastName': 'Malievsky', 'Affiliation': 'Department of Pediatrics, Bashkir State Medical University, Ufa, Russian Federation.'}, {'ForeName': 'Denise R', 'Initials': 'DR', 'LastName': 'Franco', 'Affiliation': 'CPCLIN Clinical Research Center, São Paulo, Brazil.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Department of Pediatrics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Demissie', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Wardecki', 'Affiliation': 'Sanofi, Warsaw, Poland.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""UMC - University Children's Hospital and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}]",Diabetes care,['10.2337/dc19-1926'] 1532,31600471,"Accelerating Adolescent Vocabulary Growth: Development of an Individualized, Web-Based, Vocabulary Instruction Program.","Purpose Improving vocabulary knowledge is important for many adolescents, but there are few evidence-based vocabulary instruction programs available for high school students. The purpose of this article is to describe the iterative development of the DictionarySquared research platform, a web-based vocabulary program that provides individualized vocabulary instruction, and to report the results of 2 pilot studies examining the feasibility of implementation and potential effectiveness with high school students. Method We describe our theory of change and 5 phases of iterative development. In Phases 1 and 2, we evaluated the initial implementation of DictionarySquared and revised the instructional materials. In Phase 3, we conducted a feasibility study involving 169 high school students who used the program for 4 weeks. Student usage data and feedback from teachers were used to guide program revisions in Phase 4. In Phase 5, we examined potential effectiveness for 264 high school students who were assigned to use the program for 1 semester. Results Results of the Phase 3 study indicated that implementation of the program was feasible, although usage was below assigned levels. Results of the Phase 5 study indicated that the duration of active program usage significantly predicted posttest vocabulary scores on the proximal assessment after controlling for pretest standardized vocabulary scores. Analyses using propensity score matching revealed positive, but nonsignificant, gains on standardized assessments between pre- and posttests. Conclusion Together, the results of early-stage pilot studies are promising and suggest that a more rigorous test of efficacy is warranted. Successful implementation of the DictionarySquared research program, as well as lessons learned from the program development process, will expand the range of evidence-based treatment options that clinicians and educators can use to improve adolescent vocabulary and reading comprehension skills. Supplemental Material https://doi.org/10.23641/asha.9765161.",2019,"Analyses using propensity score matching revealed positive, but nonsignificant, gains on standardized assessments between pre- and posttests.","['264 high school students', '169 high school students who used the program for 4 weeks']",['Supplemental Material https://doi.org/10.23641/asha.9765161'],[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",[],169.0,0.0141311,"Analyses using propensity score matching revealed positive, but nonsignificant, gains on standardized assessments between pre- and posttests.","[{'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Adlof', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Carolina, Columbia.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Baron', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Carolina, Columbia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Scoggins', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Carolina, Columbia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kapelner', 'Affiliation': 'Department of Mathematics, Queens College, City University of New York, NY.'}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'McKeown', 'Affiliation': 'Learning Research and Development Center, University of Pittsburgh, PA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Perfetti', 'Affiliation': 'Learning Research and Development Center, University of Pittsburgh, PA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Carolina, Columbia.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Soterwood', 'Affiliation': 'Littleforest Consulting, LLC, Santa Clara, CA.'}, {'ForeName': 'Yaacov', 'Initials': 'Y', 'LastName': 'Petscher', 'Affiliation': 'Florida Center for Reading Research, College of Social Work, Florida State University, Tallahassee.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-VOIA-18-0143'] 1533,31757693,Re: Randomized double-blind clinical trial evaluation of bone healing after third molar surgery with the use of leukocyte- and platelet-rich fibrin.,,2020,,[],['leukocyte- and platelet-rich fibrin'],[],[],"[{'cui': 'C4505052', 'cui_str': 'L-PRF'}]",[],,0.63846,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pimentel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil. Electronic address: pimentelthais@outlook.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ritto', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Canellas', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Junger', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Medeiros', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.10.018'] 1534,31553693,"High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008.","PURPOSE The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases. METHODS From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and P value were corrected for the three previous interim analyses by the inverse normal method. RESULTS Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44; P = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm. CONCLUSION In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.",2019,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16).","['Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases', 'From 2000 to 2015, we enrolled patients older than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases', 'Ewing Sarcoma', 'Selected patients requiring radiotherapy to an axial primary site', 'Of 543 potentially eligible patients']","['standard chemotherapy with WLI', 'busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI', 'Standard Chemotherapy and Lung Radiation', 'radiotherapy and busulfan', 'chemotherapy', 'High-Dose Chemotherapy', 'BuMel', 'vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI', 'VAI plus WLI']","['severe acute toxicities', 'Event-free survival', 'survival outcomes', 'overall survival', 'hazard ratio (HR']","[{'cui': 'C0553580', 'cui_str': ""Ewing's Tumor""}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0153678', 'cui_str': 'Secondary malignant neoplasm of pleura (disorder)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",287.0,0.239424,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16).","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Dirksen', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Centre Oscar Lambret, Lille; and Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Cozic', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van den Berg', 'Affiliation': 'Emma Children Hospital - Amsterdam University Medical Centres, Amsterdam, the Netherlands.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bhadri', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Brichard', 'Affiliation': 'Cliniques Universitaires Saint Luc, Brussels, Belgium.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Claude', 'Affiliation': 'Centre Léon Bérard, Lyon; France.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Craft', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Amler', 'Affiliation': 'Westfalian Wilhelms University Muenster, Muenster; and Friedrich- Loeffler Institute, Greifswald-Insel Riems, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gorlick', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Holcombe E', 'Initials': 'HE', 'LastName': 'Grier', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guinbretiere', 'Affiliation': 'Hôpital René-Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hauser', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hjorth', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Janeway', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Juergens', 'Affiliation': 'Universitaetskinderklinik Muenster, Muenster, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'Royal Marsden Foundation NHS Trust, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Krailo', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jarmila', 'Initials': 'J', 'LastName': 'Kruseova', 'Affiliation': 'Charles University Prague, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuehne', 'Affiliation': ""University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Lervat', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Lewis', 'Affiliation': 'University of Leeds, Liverpool, United Kingdom.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Linassier', 'Affiliation': 'Centre Hospitalier Universitaire, Tours, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Marec-Berard', 'Affiliation': 'Institute of Pediatric Onco-Haematology, Lyon, France.'}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'Five Time Therapeutics, South San Francisco, CA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women and Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pacquement', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paulussen', 'Affiliation': 'Witten/Herdecke University, Datteln, Germany.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'University of California Davis, Sacramento, CA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ranft', 'Affiliation': 'Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Le Teuff', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Womer', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Oberlin', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00915'] 1535,31804860,EMERGING-CTONG 1103: For Achieving High-Quality Evidence in a Randomized Phase II Trial.,,2020,,['CTONG 1103'],[],[],[],[],[],,0.0279451,,"[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Tateishi', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ishiki', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Kubo', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Satomi', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01976'] 1536,32063029,Adding new experimental arms to randomised clinical trials: Impact on error rates.,"BACKGROUND Experimental treatments pass through various stages of development. If a treatment passes through early-phase experiments, the investigators may want to assess it in a late-phase randomised controlled trial. An efficient way to do this is adding it as a new research arm to an ongoing trial while the existing research arms continue, a so-called multi-arm platform trial. The familywise type I error rate is often a key quantity of interest in any multi-arm platform trial. We set out to clarify how it should be calculated when new arms are added to a trial some time after it has started. METHODS We show how the familywise type I error rate, any-pair and all-pairs powers can be calculated when a new arm is added to a platform trial. We extend the Dunnett probability and derive analytical formulae for the correlation between the test statistics of the existing pairwise comparison and that of the newly added arm. We also verify our analytical derivation via simulations. RESULTS Our results indicate that the familywise type I error rate depends on the shared control arm information (i.e. individuals in continuous and binary outcomes and primary outcome events in time-to-event outcomes) from the common control arm patients and the allocation ratio. The familywise type I error rate is driven more by the number of pairwise comparisons and the corresponding (pairwise) type I error rates than by the timing of the addition of the new arms. The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30. CONCLUSIONS The findings we present in this article can be used to design trials with pre-planned deferred arms or to add new pairwise comparisons within an ongoing platform trial where control of the pairwise error rate or familywise type I error rate (for a subset of pairwise comparisons) is required.",2020,"The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30. ",[],[],[],[],[],[],,0.202982,"The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30. ","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Choodari-Oskooei', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bratton', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Gannon', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Meade', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mahesh Kb', 'Initials': 'MK', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774520904346'] 1537,31969713,Correction to: Effectiveness and tolerability of lidocaine 5% spray in the treatment of lifelong premature ejaculation patients: a randomized single-blind placebo-controlled clinical trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['lifelong premature ejaculation patients'],"['lidocaine', 'placebo']",['Effectiveness and tolerability'],"[{'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0706763,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Mohammed Abu', 'Initials': 'MA', 'LastName': 'El-Hamd', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University, Sohag, Egypt. mohammedadva@yahoo.com.'}]",International journal of impotence research,['10.1038/s41443-020-0229-5'] 1538,31986098,"Response by Bergmark et al to Letter Regarding Article, ""Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial"".",,2020,,"['Patients', 'With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}]",[],[],,0.0160972,,"[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.A.B., D.L.B., B.M.S.).""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.A.B., D.L.B., B.M.S.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.A.B., D.L.B., B.M.S.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.044819'] 1539,32007610,"Pilonidal sinus disease: If many methods stand time's test, the best may mirror all the rest. A commentary on: ""Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus"" [Int. J. Surg. 2020;74:81-5].",,2020,,[],[],[],[],[],[],,0.0191392,,"[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Department of Gastrosurgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.01.134'] 1540,32428718,Prospective Randomized Study on the Effects of Improved Sleep Quality After Craniotomy on Melatonin Concentrations and Inflammatory Response in Neurosurgical Intensive Care Patients.,"OBJECTIVE Sleep disorders in intensive care units after a craniotomy can decrease melatonin secretion and increase the inflammatory stress response. The aim of this study was to investigate the influence of improving sleep quality via eye patches and earplugs on melatonin secretion and inflammatory mediator release. METHODS The study enrolled 41 patients who underwent craniotomy. Patients were randomized into 2 groups. ""Group Intervention"" received a sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while ""Group Control"" received standard care. Blood levels of C-reactive protein and interleukin 1 and interleukin 6 along with urine levels of 6-sulphatoxymelatonin (aMT6) were measured preoperatively (baseline) and on postoperative days 1 and 3. Sleep quality was assessed with the Richards-Campbell Sleep Questionnaire. RESULTS Sleep quality was higher in the intervention group (Richards-Campbell score:80.61 ± 11.96 vs. 33.50 ± 16.32; P < 0.001). Urine aMT6 levels increased significantly in the intervention group in spot urine samples from 10.15 (5.38-14.40) ng/mL at baseline to 14.52 (6.24-29.11) and 11.51 (7.88-29.05) ng/mL on postoperative days 1 and 3. They also increased in 24-hour urine samples from 25.73 (8.24-52.73) ng/mL at baseline to 35.38 (11.48-95.65) and 39.18 (2.36-125.23) ng/mL on postoperative days 1 and 3 (P = 0.001 and P = 0.005, respectively). The aMT6 concentration did not change significantly in the control group. The C-reactive protein concentrations increased postoperatively compared with baseline concentrations in both groups (P = 0.001 and P < 0.001). CONCLUSIONS Melatonin secretion significantly increased as a result of improving postoperative sleep quality by noise and light isolation in neurosurgical intensive care unit patients after craniotomy.",2020,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001). ","['neurosurgical ICU patients after craniotomy', 'neurosurgical intensive-care patients 2 ', '41 patients who underwent craniotomy']","['sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while Group Control received standard care']","['levels', 'Blood levels of C reactive protein (CRP) and interleukin 1(IL-1) and 6 (IL-6) along with urine levels of 6-sulphatoxymelatonin (aMT6', '24-hour urine samples', 'aMT6 concentration', 'Urine aMT6', 'Sleep quality', 'postoperative sleep quality', 'CRP concentrations', 'melatonin secretion', 'sleep quality', 'inflammatory stress response']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C1135964', 'cui_str': 'Ear plug'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0049713', 'cui_str': '6-sulfatoxymelatonin'}, {'cui': 'C0456209', 'cui_str': '24 hour urine sample'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",41.0,0.140342,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001). ","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arık', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey. Electronic address: emineincearik@yahoo.com.'}, {'ForeName': 'Habibullah', 'Initials': 'H', 'LastName': 'Dolgun', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Hanalioglu', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Omer Selcuk', 'Initials': 'OS', 'LastName': 'Sahin', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ucar', 'Affiliation': 'Department of Clinical Biochemistry, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yazicioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Dogan', 'Affiliation': 'Department of Neurosurgery, Ankara University, İbn-i Sina Hospital, Ankara, Turkey.'}, {'ForeName': 'Erdal Resit', 'Initials': 'ER', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}]",World neurosurgery,['10.1016/j.wneu.2020.05.017'] 1541,31050763,Effect of Cognitive Behavioral Therapy on Clinical Disease Course in Adolescents and Young Adults With Inflammatory Bowel Disease and Subclinical Anxiety and/or Depression: Results of a Randomized Trial.,"BACKGROUND Anxiety and depressive symptoms are prevalent in patients with inflammatory bowel disease (IBD) and may negatively influence disease course. Disease activity could be affected positively by treatment of psychological symptoms. We investigated the effect of cognitive behavioral therapy (CBT) on clinical disease course in 10-25-year-old IBD patients experiencing subclinical anxiety and/or depression. METHODS In this multicenter parallel group randomized controlled trial, IBD patients were randomized to disease-specific CBT in addition to standard medical care (CBT + care us usual [CAU]) or CAU only. The primary outcome was time to first relapse in the first 12 months. Secondary outcomes were clinical disease activity, fecal calprotectin, and C-reactive protein (CRP). Survival analyses and linear mixed models were performed to compare groups. RESULTS Seventy patients were randomized (CBT+CAU = 37, CAU = 33), with a mean age of 18.3 years (±50% < 18 y, 31.4% male, 51.4% Crohn's disease, 93% in remission). Time to first relapse did not differ between patients in the CBT+CAU group vs the CAU group (n = 65, P = 0.915). Furthermore, clinical disease activity, fecal calprotectin, and CRP did not significantly change over time between/within both groups. Exploratory analyses in 10-18-year-old patients showed a 9% increase per month of fecal calprotectin and a 7% increase per month of serum CRP in the CAU group, which was not seen in the CAU+CBT group. CONCLUSIONS CBT did not influence time to relapse in young IBD patients with subclinical anxiety and/or depression. However, exploratory analyses may suggest a beneficial effect of CBT on inflammatory markers in children.",2019,"Time to first relapse did not differ between patients in the CBT+CAU group vs the CAU group (n = 65, P = 0.915).","['children', 'IBD patients', 'Adolescents and Young Adults With Inflammatory Bowel Disease and Subclinical Anxiety', 'young IBD patients with subclinical anxiety and/or depression', 'patients with inflammatory bowel disease (IBD', '10-25-year-old IBD patients experiencing subclinical anxiety and/or depression', ""Seventy patients were randomized (CBT+CAU = 37, CAU = 33), with a mean age of 18.3 years (±50% < 18 y, 31.4% male, 51.4% Crohn's disease, 93% in remission""]","['cognitive behavioral therapy (CBT', 'disease-specific CBT in addition to standard medical care (CBT + care us usual', 'CAU', 'Cognitive Behavioral Therapy', 'CBT']","['fecal calprotectin', 'clinical disease activity, fecal calprotectin, and C-reactive protein (CRP', 'Time to first relapse', 'serum CRP', 'clinical disease activity, fecal calprotectin, and CRP', 'time to first relapse', 'Disease activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",70.0,0.145073,"Time to first relapse did not differ between patients in the CBT+CAU group vs the CAU group (n = 65, P = 0.915).","[{'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'van den Brink', 'Affiliation': ""Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Luuk', 'Initials': 'L', 'LastName': 'Stapersma', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Anna Sophia', 'Initials': 'AS', 'LastName': 'Bom', 'Affiliation': ""Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Rizopolous', 'Affiliation': 'Department of Biostatistics, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'C Janneke', 'Initials': 'CJ', 'LastName': 'van der Woude', 'Affiliation': 'Department of Gastroenterology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Rogier J L', 'Initials': 'RJL', 'LastName': 'Stuyt', 'Affiliation': 'Department of Gastroenterology, Haga Hospital, Den Haag, the Netherlands.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Hendriks', 'Affiliation': ""Department of Pediatrics, Juliana Children's Hospital, Den Haag, the Netherlands.""}, {'ForeName': 'Joyce A T', 'Initials': 'JAT', 'LastName': 'van der Burg', 'Affiliation': ""Department of Pediatrics, Juliana Children's Hospital, Den Haag, the Netherlands.""}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Beukers', 'Affiliation': 'Department of Gastroenterology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Thea A', 'Initials': 'TA', 'LastName': 'Korpershoek', 'Affiliation': 'Department of Gastroenterology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Sabine D M', 'Initials': 'SDM', 'LastName': 'Theuns-Valks', 'Affiliation': 'Department of Pediatrics, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Elisabeth M W J', 'Initials': 'EMWJ', 'LastName': 'Utens', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Escher', 'Affiliation': ""Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.""}]",Inflammatory bowel diseases,['10.1093/ibd/izz073'] 1542,31884564,24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients.,"OBJECTIVE The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG). METHODS This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs). RESULTS At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. CONCLUSIONS Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364.",2020,"After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. ","['Glaucoma Patients', 'patients with open-angle glaucoma (OAG', 'adult patients with OAG (N\xa0=\u200975) received']","['topical bimatoprost 0.03% once daily', 'Bimatoprost SR', 'Bimatoprost Sustained-Release Implant (Bimatoprost SR', 'biodegradable bimatoprost sustained-release implant (Bimatoprost SR']","['safety and intraocular pressure (IOP)-lowering effects', 'overall AE incidence', 'adverse events (AEs', 'IOP change', 'favorable efficacy and safety profiles', 'mean IOP reduction']","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C4517402', 'cui_str': '0.03 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.167087,"After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. ","[{'ForeName': 'E Randy', 'Initials': 'ER', 'LastName': 'Craven', 'Affiliation': 'Johns Hopkins University School of Medicine, 600 N. Wolfe Street, 110, Baltimore, MD, 21287, USA. erandycraven@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walters', 'Affiliation': 'Keystone Research, Ltd, Austin, TX, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Christie', 'Affiliation': 'Scott & Christie and Associates, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Day', 'Affiliation': 'Coastal Research Associates, Roswell, GA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Sacramento Eye Consultants, Sacramento, CA, USA.'}, {'ForeName': 'Margot L', 'Initials': 'ML', 'LastName': 'Goodkin', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Wangsadipura', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Robinson', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bejanian', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-019-01248-0'] 1543,32430507,"Impact of Myc in HIV-associated Non-Hodgkin Lymphomas Treated with EPOCH, and Outcomes with Vorinostat (AMC075 Trial).","EPOCH is a preferred regimen for HIV-NHLs, which are frequently EBV+ or HHV-8+. The histone deacetylase (HDAC) inhibitor vorinostat disrupts EBV/HHV-8 latency, enhances chemotherapy-induced cell death, and may clear HIV reservoirs. To assess whether vorinostat increases EPOCH efficacy and/or HIV clearance we performed a randomized phase 2 study in 90 patients (45 per arm) with aggressive HIV-NHLs using dose-adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle. Up to 1 prior cycle of systemic chemotherapy was allowed. The primary endpoint was complete response (CR). In 86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1), CR rates were 74% versus 68% for EPOCH versus EPOCH-vorinostat, respectively (1-sided P=0.72). Patients with CD4+ count <200 cells/mm3 had a lower CR rate. EPOCH-vorinostat did not eliminate HIV reservoirs and resulted in more frequent grade 4 neutropenia and thrombocytopenia (47% and 29%, respectively) versus EPOCH (20% and 2%, respectively). The overall and event-free survival (EFS) rates were similar between arms. Overall, patients with Myc+ DLBCL had significantly lower EFS (44% at 3-yr, versus 83% in Myc- DLBCL). Low diagnosis-to-treatment interval (DTI) was also associated with inferior outcomes, while pre-protocol therapy had no negative impact. In conclusion, EPOCH had broad efficacy against highly aggressive HIV-NHLs, while vorinostat had no benefit; patients with Myc-driven DLBCL, low CD4, and low DTI had less favorable outcomes. Permitting pre-protocol therapy facilitated accruals without compromising outcomes. NCT0119384.",2020,The overall and event-free survival (EFS) rates were similar between arms.,"['86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1', '90 patients (45 per arm) with aggressive HIV-NHLs using dose']",['adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle'],"['CR rates', 'EPOCH efficacy', 'complete response (CR', 'Low diagnosis-to-treatment interval (DTI', 'EFS', 'overall and event-free survival (EFS) rates', 'and/or HIV clearance', 'frequent grade 4 neutropenia and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0079746', 'cui_str': ""Diffuse non-Hodgkin's lymphoma, immunoblastic (clinical)""}, {'cui': 'C1292753', 'cui_str': 'Primary effusion lymphoma'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",90.0,0.175059,The overall and event-free survival (EFS) rates were similar between arms.,"[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Weill Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Reid', 'Affiliation': 'Moores UCSD Cancer Center, La Jolla, California, United States.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Siegel', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States.'}, {'ForeName': 'Page C', 'Initials': 'PC', 'LastName': 'Moore', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Rubinstein', 'Affiliation': 'John H. Stroger Hospital of Cook County, Chicago, Illinois, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Durand', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Cesarman', 'Affiliation': 'Weill Cornell Medicine, New York, New York, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Aboulafia', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Baiocchi', 'Affiliation': 'Ohio State University, Colmubus, Ohio, United States.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ratner', 'Affiliation': 'Washington University, St. Louis, Missouri, United States.'}, {'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'University of California, San Francisco, San Francisco, California, United States.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Capoferri', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'U. of Arkansas for Medical Sciences, :Little Rock, Arkansas, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'UCLA, Los Angeles, California, United States.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Noy', 'Affiliation': 'Weill Cornell Medicine, United States.'}]",Blood,['10.1182/blood.2019003959'] 1544,31697587,Bevacizumab As Maintenance Treatment in Patients With Ovarian Cancer: Wait for BRCA Testing.,,2020,,['Patients With Ovarian Cancer'],['Bevacizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0204737,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Farolfi', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02055'] 1545,32428227,The role of the inferior parietal lobule in writer's cramp.,"Humans have a distinguishing ability for fine motor control that is subserved by a highly evolved cortico-motor neuronal network. The acquisition of a particular motor skill involves a long series of practice movements, trial and error, adjustment and refinement. At the cortical level, this acquisition begins in the parieto-temporal sensory regions and is subsequently consolidated and stratified in the premotor-motor cortex. Task-specific dystonia can be viewed as a corruption or loss of motor control confined to a single motor skill. Using a multimodal experimental approach combining neuroimaging and non-invasive brain stimulation, we explored interactions between the principal nodes of the fine motor control network in patients with writer's cramp and healthy matched controls. Patients and healthy volunteers underwent clinical assessment, diffusion-weighted MRI for tractography, and functional MRI during a finger tapping task. Activation maps from the task-functional MRI scans were used for target selection and neuro-navigation of the transcranial magnetic stimulation. Single- and double-pulse TMS evaluation included measurement of the input-output recruitment curve, cortical silent period, and amplitude of the motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation in a randomized, sham-controlled design. Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions were facilitatory and inhibitory, respectively, in healthy volunteers, whereas the interactions were converse and significantly different in writer's cramp. Baseline PMv-M1 interactions were inhibitory and similar between the groups. The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed. Cortical silent period was significantly prolonged in writer's cramp. Making a long term depression-like plastic change to dIPL node transformed the aIPL-M1 interaction to inhibitory (similar to healthy volunteers) and cancelled the PMv-M1 inhibition only in the writer's cramp group. These findings suggest that the parietal multimodal sensory association region could have an aberrant downstream influence on the fine motor control network in writer's cramp, which could be artificially restored to its normal function.",2020,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[""patients with writer's cramp and healthy matched controls"", ""writer's cramp"", 'Patients and healthy volunteers', 'healthy volunteers']","['motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation', 'multimodal experimental approach combining neuroimaging and non-invasive brain stimulation', 'Single- and double-pulse TMS']","['structural connectivity', 'Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions', 'dIPL-PMv resting state functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154676', 'cui_str': ""Organic writer's cramp""}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0232120', 'cui_str': 'Double pulse'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0340364', 'cui_str': 'Familial mitral valve prolapse'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0317236,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[{'ForeName': 'Shabbir Hussain I', 'Initials': 'SHI', 'LastName': 'Merchant', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangos', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradson', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Vial-Undurraga', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Leodori', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Bushnell', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Silvina G', 'Initials': 'SG', 'LastName': 'Horovitz', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Traian', 'Initials': 'T', 'LastName': 'Popa', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa138'] 1546,31246224,Effect of Introducing a Default Order in the Electronic Medical Record on Unnecessary Daily Imaging During Palliative Radiotherapy for Adults With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial.,,2019,,['Adults With Cancer'],['Palliative Radiotherapy'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.230884,,"[{'ForeName': 'Sonam', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Guttmann', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Penn Center for Cancer Care Innovation at the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, Penn Medicine Center for Innovation, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Penn Center for Cancer Care Innovation at the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bekelman', 'Affiliation': 'Penn Center for Cancer Care Innovation at the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA oncology,['10.1001/jamaoncol.2019.1432'] 1547,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS. METHODS The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period. RESULTS The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2 = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. CONCLUSIONS Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. ","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. ","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106'] 1548,31515173,"Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial.","BACKGROUND Combination nicotine replacement therapy shows additive cessation benefits. We aimed to find out the effectiveness of combining nicotine patches with an e-cigarette (with and without nicotine) on six-month smoking abstinence. METHODS We did a pragmatic, three-arm, parallel-group trial in New Zealand in adult smokers who were e-cigarette naive and motivated to quit smoking. Participants were recruited from the general population using national media advertising. Participants were randomly assigned (1:4:4), with the use of stratified block randomisation, to receive 14 weeks (2 weeks before the agreed quit date) of 21 mg, 24h nicotine patches, patches plus an 18 mg/L nicotine e-cigarette, or patches plus a nicotine-free e-cigarette. We advised participants to use one patch daily, with e-cigarette use as and when necessary or desired. Participants and researchers were masked to e-liquid nicotine content. We offered 6 weeks of telephone-delivered behavioural support. The primary outcome was exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months after the agreed quit date. Primary analysis was by intention to treat, with sensitivity analysis by per protocol, treatment adherence, varying CO cutoffs, and complete case analysis. This paper presents the main analyses and is registered with ClinicalTrials.gov, NCT02521662. FINDINGS Between March 17, 2016 and Nov 30, 2017, 1124 people were assigned to nicotine patches (patches only group, n=125), patches plus a nicotine e-cigarette (patches plus nicotine e-cigarette group, n=500), or patches plus a nicotine-free e-cigarette (patches plus nicotine-free e-cigarette group, n=499). 62 (50%) of 125 participants in the patches only group withdrew or were lost to follow-up by 6 months compared with 161 (32%) of 500 in the patches plus nicotine e-cigarette group and 162 (33%) of 499 in the patches plus nicotine-free e-cigarette group. 35 (7%) participants in the patches plus nicotine e-cigarette group had CO-verified continuous abstinence at 6 months compared with 20 (4%) in the patches plus nicotine-free e-cigarette group (risk difference [RD] 2·99 [95% CI 0·17-5·81]), and three (2%) people in the patches only group (RD 4·60 [1·11-8·09]). 18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group. In the patches plus nicotine e-cigarette group, two life-threatening serious adverse events were reported (two separate heart attacks in the one participant). In the patches plus nicotine-free e-cigarette group, one death occurred (accidental drug overdose) and one life-threatening serious adverse event (heart attack). No significant between-group differences were noted for serious adverse events, and none were treatment-related. INTERPRETATION Combining reduced-harm nicotine products, such as nicotine patches with a nicotine e-cigarette, can lead to a modest improvement in smoking cessation over and above that obtained from using patches plus a nicotine-free e-cigarette (or patches alone), with no indication of any serious harm in the short-term. Future e-cigarette trials should focus on their use alone or in combination with usual smoking cessation support, given issues with differential loss to follow-up and withdrawal if a usual care group is used as a comparator. FUNDING Health Research Council of New Zealand.",2020,18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group.,"['adult smokers who were e-cigarette naive and motivated to quit smoking', 'Participants were recruited from the general population using national media advertising', '62 (50%) of 125 participants in the patches', 'Between March 17, 2016 and Nov 30, 2017, 1124 people were assigned to']","['nicotine e-cigarette', 'nicotine-free e-cigarette group', 'nicotine patches, patches plus an 18 mg/L nicotine e-cigarette, or patches plus a nicotine-free e-cigarette', 'nicotine patches with an e-cigarette (with and without nicotine', 'Nicotine patches used in combination with e-cigarettes (with and without nicotine', 'telephone-delivered behavioural support', 'nicotine replacement therapy', 'nicotine patches (patches only group, n=125), patches plus a nicotine e-cigarette (patches plus nicotine e-cigarette group, n=500), or patches plus a nicotine-free e-cigarette (patches plus nicotine-free e-cigarette']","['intention to treat, with sensitivity analysis by per protocol, treatment adherence, varying CO cutoffs, and complete case analysis', 'CO-verified continuous abstinence', '18 serious adverse events', 'smoking cessation', 'death occurred (accidental drug overdose) and one life-threatening serious adverse event (heart attack', 'serious adverse events', 'exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0520803', 'cui_str': 'Accidental drug overdose (disorder)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",125.0,0.0725699,18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group.,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: n.walker@auckland.ac.nz.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parag', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Verbiest', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Laking', 'Affiliation': 'Department of Oncology, School of Medical Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Laugesen', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, The University of Auckland, Auckland, New Zealand.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30269-3'] 1549,29485340,Incentive spirometry and positive expiratory pressure improve ventilation and recruitment in postoperative recovery: A randomized crossover study.,"Introduction : Impairment of global and regional pulmonary ventilations is a well-known consequence of general anesthesia. Positive expiratory pressure (PEP) or incentive spirometry (IS) is commonly prescribed, albeit their efficacy is poorly demonstrated. The aim of this study was to assess the effects of PEP and IS on lung ventilation and recruitment in patients after surgery involving anesthesia using electrical impedance tomography (EIT). Method : Ten male subjects (age = 61.2 ± 16.3 years; BMI = 25.3 ± 3.8 kg/m 2 ), free of pulmonary disease before being anesthetized, were recruited. Two series of manoeuvers (PEP and volume-oriented IS) were randomly performed with quiet breathing interposed between these phases. Pulmonary ventilation (ΔEELVVT ( i  -  e )) and recruitment (ΔEELI) were evaluated continuously in a semi-seated position during all phases by EIT. Comparisons between rest and treatment were performed by Wilcoxon signed rank test. Rest phases were compared by a mixed ANOVA. Bonferroni method was used for post-hoc comparisons. Results : ΔEELVVT ( i  -  e ) and ΔEELI were significantly increased by both techniques (+422% [ p  < 0.001]; +138% [ p  = 0.040] and +296% [ p  < 0.001]; +638% [ p  < 0.001] for PEP and IS, respectively). No difference was observed between both manoeuvers neither on ventilation nor on recruitment. This positive effect disappeared during the quiet breathing phases. Conclusion : IS and PEP improved ventilation and recruitment instantaneously without remnant effect after stopping the exercise.",2019,No difference was observed between both manoeuvers neither on ventilation nor on recruitment.,"['patients after surgery involving anesthesia using electrical impedance tomography (EIT', 'Ten male subjects (age\xa0=\xa061.2\xa0±\xa016.3\xa0years; BMI\xa0=\xa025.3\xa0±\xa03.8\xa0kg/m 2 ), free of pulmonary disease before being anesthetized, were recruited', 'postoperative recovery']","['PEP', 'Incentive spirometry and positive expiratory pressure improve ventilation']","['ΔEELI', 'Positive expiratory pressure (PEP) or incentive spirometry (IS', 'Pulmonary ventilation (ΔEELVVT (i\xa0-\xa0e)) and recruitment (ΔEELI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry (regime/therapy)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry (regime/therapy)'}, {'cui': 'C0035213', 'cui_str': 'Respiratory Airflow'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",10.0,0.0460672,No difference was observed between both manoeuvers neither on ventilation nor on recruitment.,"[{'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Valeska', 'Initials': 'V', 'LastName': 'Uribe Rodriguez', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Cheryl Elizabeth', 'Initials': 'CE', 'LastName': 'Hickmann', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': ""Service d'Urologie, Cliniques universitaires Saint-Luc, Brussels, Belgium.""}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Feyaerts', 'Affiliation': ""Service d'Urologie, Cliniques universitaires Saint-Luc, Brussels, Belgium.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Roeseler', 'Affiliation': 'Service de Soins Intensifs, Cliniques universitaires Saint-Luc, Brussels, Belgium.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1443185'] 1550,31845007,Pilot study of a telehealth perioperative physical activity intervention for older adults with cancer and their caregivers.,"BACKGROUND Older adults undergoing cancer surgery are at greater risk for poor postoperative outcomes. Caregivers also endure significant burden. Participation in perioperative physical activity may improve physical functioning and enhance overall well-being for both patients and caregivers. In this study, we assessed the feasibility of a personalized telehealth intervention to enhance physical activity for older (≥ 65 years) gastrointestinal (GI) and lung cancer surgery patients/caregivers. METHODS Participants completed four telehealth sessions with physical therapy/occupational therapy (PT/OT) before surgery and up to 2 weeks post-discharge. Outcomes included preop geriatric assessment, functional measures, and validated measures for symptoms and psychological distress. Pre/post-intervention trends/trajectories for outcomes were explored. RESULTS Thirty-four patient/caregiver dyads (16, GI; 18, lung) were included. Accrual rate was 76% over 8 months; retention rate was 88% over 2 months. Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores improved from baseline to postop. Participant satisfaction scores were high. CONCLUSION Our conceptually based, personalized, multimodal, telehealth perioperative physical activity intervention for older patient/caregiver dyads is feasible and acceptable. It offers an opportunity to improve postoperative outcomes by promoting functional recovery through telehealth, behavior change, and self-monitoring approaches. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03267524.",2020,"Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores improved from baseline to postop.","['Thirty-four patient/caregiver dyads (16', '65\xa0years) gastrointestinal (GI) and lung cancer surgery patients/caregivers', 'older patient/caregiver dyads', 'Participants completed four', 'older adults with cancer and their caregivers', 'older (≥', 'Older adults undergoing cancer surgery']","['telehealth perioperative physical activity intervention', 'telehealth sessions with physical therapy/occupational therapy (PT/OT', 'personalized telehealth intervention']","['retention rate', 'preop geriatric assessment, functional measures, and validated measures for symptoms and psychological distress', 'Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores', 'Participant satisfaction scores', 'Accrual rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0920424'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0476829,"Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores improved from baseline to postop.","[{'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Lafaro', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Raz', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Hite', 'Affiliation': 'Department of Rehabilitation, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Ruel', 'Affiliation': 'Department of Information Sciences, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Gouri', 'Initials': 'G', 'LastName': 'Varatkar', 'Affiliation': 'Department of Rehabilitation, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Erhunmwunsee', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Melstrom', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Byrne', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Yuman', 'Initials': 'Y', 'LastName': 'Fong', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Sun', 'Affiliation': 'Department of Surgery, City of Hope, Duarte, CA, USA. vsun@coh.org.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05230-0'] 1551,31514168,"Effect of Drop Height on Vertical Jumping Performance in Pre-, Circa-, and Post-Pubertal Boys and Girls.","PURPOSE To examine the effect of drop height on vertical jumping performance in children with respect to sex and maturity status. METHODS Thirty-seven pre-pubertal, 71 circa-pubertal, and 69 post-pubertal boys and girls performed, in a randomized order, 2 squat jumps, 2 countermovement jumps, and 2 drop jumps (DJ) from heights of 20, 30, 40, 50, 60, and 70 cm. The trial with the best jump height in each test was used for analysis. RESULTS No significant sex × maturity status × jump type interaction for jump height was observed. However, on average, the children jumped higher in the countermovement jump than in squat jump and DJs (+1.2 and +1.6 cm, P < .001, respectively), with no significant differences between DJs and squat jumps or between DJs when increasing drop heights. Regarding DJs, 59.3% of the participants jumped higher from drop heights of 20 to 40 cm. CONCLUSIONS Children, independent of sex and maturity status, performed best in the countermovement jump, and no performance gain was obtained by dropping from heights of 20 to 70 cm. During maturation, the use of drop heights between 20 and 40 cm may be considered in plyometric training, but the optimum height must be obtained individually.",2020,"However, on average, the children jumped higher in the countermovement jump than in squat jump and DJs (+1.2 and +1.6 cm, P < .001, respectively), with no significant differences between DJs and squat jumps or between DJs when increasing drop heights.","['69 post-pubertal boys and girls', 'Pre-, Circa-, and Post-Pubertal Boys and Girls', 'children with respect to sex and maturity status', 'Thirty-seven pre-pubertal, 71 circa-pubertal, and']",['Drop Height'],['performance gain'],"[{'cui': 'C1626404', 'cui_str': 'Post-pubertal'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}]","[{'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]",[],37.0,0.0389517,"However, on average, the children jumped higher in the countermovement jump than in squat jump and DJs (+1.2 and +1.6 cm, P < .001, respectively), with no significant differences between DJs and squat jumps or between DJs when increasing drop heights.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Birat', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebillaud', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bourdier', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Doré', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duché', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Edith Cowan University.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Patikas', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Ratel', 'Affiliation': 'Université Clermont Auvergne.'}]",Pediatric exercise science,['10.1123/pes.2019-0120'] 1552,31514191,Evaluating the Outcome of Two Different Regimes in Adhesive Capsulitis: A Prospective Clinical Study.,"OBJECTIVE Adhesive capsulitis or frozen shoulder is a painful condition affecting up to 5% of the general population. We conducted this study with the aim of evaluating the results of physiotherapy plus intra-articular methylprednisolone injection versus physiotherapy alone in idiopathic frozen shoulder. METHODS This prospective clinical study was conducted in a tertiary care center between August 2016 and August 2018. Patients who were diagnosed with idiopathic frozen shoulder were included in the study, and each patient was randomly allocated to one of two groups: physiotherapy alone (group A) and physiotherapy plus intra-articular steroid injection (group B). RESULTS A total of 52 cases diagnosed with idiopathic frozen shoulder were included and treated with the two modalities. There was a significant improvement in group B compared to group A at 6 weeks and 3 months in the range of flexion, abduction, and external rotation. The Shoulder Pain and Disability Index showed improvement in both pain and disability score in group B -compared to group A, and improvement was significant at 6 weeks and 3 months. CONCLUSION The results demonstrate the advantages of physiotherapy plus intra-articular steroid injection in idiopathic frozen shoulder. The predictability of results with physiotherapy plus intra-articular steroid injection in selected patients is excellent, and it is a better modality of treatment compared to physiotherapy alone.",2020,"There was a significant improvement in Group B as compared to Group A at 6 weeks and 3 months in the range of flexion, abduction and external rotation.","['52 cases diagnosed with idiopathic frozen shoulder', 'tertiary care centre between August 2016 to August 2018', 'Patients who were diagnosed with idiopathic frozen shoulder were included in the study and each patient', 'idiopathic frozen shoulder', 'Adhesive Capsulitis']","['intra-articular methylprednisolone with physiotherapy versus physiotherapy alone', 'intra-articular steroid plus physiotherapy', 'physiotherapy alone and physiotherapy and intra articular injection', 'physiotherapy alone (Group A) and physiotherapy and intra-articular steroid injection (Group B']","['Shoulder pain and disability index (SPADI', 'pain and disability score']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0429527,"There was a significant improvement in Group B as compared to Group A at 6 weeks and 3 months in the range of flexion, abduction and external rotation.","[{'ForeName': 'Rashid', 'Initials': 'R', 'LastName': 'Anjum', 'Affiliation': 'ASCOMS & Hospital, Jammu, India, raashidanjum@gmail.com.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Aggarwal', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Gautam', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Aryan', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000503317'] 1553,31518717,Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial.,"BACKGROUND & AIMS Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.",2020,"Proportions of patients with dysphagia decreased from 15% to 7% (P<.005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P<.001) from study entry to 1-year after MSA (Combined P<.001).","['Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n=152', 'patients with moderate to severe regurgitation despite once-daily PPI therapy', 'n=50) at 20 sites, from July 2015 through February 2017', 'Regurgitative gastroesophageal reflux disease (GERD']","['Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors', 'twice-daily PPIs', 'PPI therapy', 'MSA', 'proton-pump inhibitors (PPIs', 'laparoscopic MSA', 'magnetic sphincter augmentation (MSA', 'PPI therapy, MSA']","['peri-operative events, device explants, erosions, or migrations', 'control of regurgitation', 'Proportions of patients with dysphagia', 'GERD health-related quality of life improvement scores', 'bloating', 'regurgitation', 'foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use', 'Regurgitation, foregut scores, esophageal acid exposure, and adverse events', 'esophageal acid exposure time', 'severe regurgitation and excess reflux episodes', 'Relief of regurgitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",,0.0512771,"Proportions of patients with dysphagia decreased from 15% to 7% (P<.005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P<.001) from study entry to 1-year after MSA (Combined P<.001).","[{'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Bell', 'Affiliation': 'Institute of Esophageal and Reflux Surgery, Englewood, Colorado. Electronic address: reg@iersurgery.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lipham', 'Affiliation': 'Department of Surgery, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Louie', 'Affiliation': 'Division of Thoracic Surgery, Swedish Medical Center, Seattle, Washington.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': ""Thoracic Surgery Department, St. Elizabeth's Healthcare, Edgewood, Kentucky.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luketich', 'Affiliation': 'Division of Thoracic Surgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Surgery, Adirondack Medical Center and Adirondack Surgical Group, Saranac Lake, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Richards', 'Affiliation': 'Department of Surgery, University of South Alabama, Mobile, Alabama.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Dunst', 'Affiliation': 'Department of Surgery, Oregon Clinic, Portland, Oregon.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lister', 'Affiliation': 'Arkansas Heartburn Treatment Center, Baptist Health Medical Center, Heber Springs, Arkansas.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McDowell-Jacobs', 'Affiliation': 'Department of Surgery, Knox Community Hospital, Mount Vernon, Ohio.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Reardon', 'Affiliation': 'Department of Surgery, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Woods', 'Affiliation': 'Department of Medicine, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Gould', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'F Paul', 'Initials': 'FP', 'LastName': 'Buckley', 'Affiliation': 'Department of Surgery and Perioperative Care, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Shanu', 'Initials': 'S', 'LastName': 'Kothari', 'Affiliation': 'Department of Surgery, Prisma Health, Greenville, South Carolina.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Khaitan', 'Affiliation': 'Department of Surgery, Digestive Health Institute, University Hospitals, Cleveland Medical Center, Cleveland, Cleveland, Ohio.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Smith', 'Affiliation': 'Esophageal Institute of Atlanta, Atlanta, Georgia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Anne Arundel Health System and Johns Hopkins Medicine, Annapolis, Maryland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Albany Surgical PC, Albany, Georgia.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Surgery, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Abbas', 'Affiliation': 'Division of Thoracic Surgery, West Virginia University School of Medicine, Morgantown, West Virginia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Katz', 'Affiliation': 'Department of Gastroenterology, Weill Cornell Medicine, New York, New York.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.08.056'] 1554,32434813,"Correction: Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) .",,2020,,['patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) '],['ixekizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}]",[],,0.135237,,[],Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216118corr1'] 1555,32025741,Post hoc analysis of the improvement in shoulder spasticity and safety observed following treatment with incobotulinumtoxinA.,"OBJECTIVE The Titration study in lOWer and uppER-limb spasticity (TOWER) study (NCT01603459), evaluated incobotulinumtoxinA for upper- and lower-limb spasticity. This post hoc analysis assessed shoulder spasticity in patients who received injections into the shoulder. METHODS Subjects received 3 injection cycles with escalating incobotulinumtoxinA doses on the same side (400, 600, 600-800 U; ≤ 600 U per limb including optional shoulder dose, planned range 100-250 U). Joint function was assessed with the Ashworth Scale shoulder sumscore (AS-SSS) in subjects treated in the shoulder vs those who were not. Safety was assessed in subjects treated in the shoulder, and in those who had upper-limb treatment without shoulder treatment. RESULTS The proportion of subjects receiving shoulder treatment increased with escalating dose at each cycle (n = 84/140 (60.0%) by cycle 3; mean (standard deviation (SD)) shoulder dose 118.4 U (SD 60.2)). From baseline to 4-weeks post-injection, mean AS-SSS improved by -1.1 (SD 1.9), -1.7 (SD 1.8) and -1.7 (1.8) in cycles 1, 2 and 3, respectively, in subjects treated in the shoulder, and -0.5 (SD 1.3), -0.8 (SD 1.6) and -0.9 (SD 1.4) in subjects who were not. A significant dose effect on AS-SSS was observed in cycle 3 (p = 0.0081). No unexpected safety concerns were reported. CONCLUSION The results demonstrate an improvement in shoulder spasticity and safety following incobotulinumtoxinA treatment.",2020,Joint function was assessed with the Ashworth Scale shoulder sumscore (AS-SSS) in subjects treated in the shoulder vs those who were not.,"['patients who received injections into the shoulder', 'subjects treated in the shoulder, and in those who had upper-limb treatment without shoulder treatment', 'Subjects received']","['3 injection cycles with escalating incobotulinumtoxinA', 'incobotulinumtoxinA']","['Ashworth Scale shoulder sumscore (AS-SSS', 'AS-SSS', 'shoulder spasticity', 'Joint function', 'proportion of subjects receiving shoulder treatment', 'Safety', 'shoulder spasticity and safety', 'mean AS-SSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}]","[{'cui': 'C0222045'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.125484,Joint function was assessed with the Ashworth Scale shoulder sumscore (AS-SSS) in subjects treated in the shoulder vs those who were not.,"[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Wissel', 'Affiliation': ''}, {'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': ''}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Scheschonka', 'Affiliation': ''}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Flatau-Baqué', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Simpson', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2651'] 1556,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support. METHODS We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record. RESULTS We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes. CONCLUSION It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026'] 1557,32434381,Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.,"BACKGROUND In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention. METHODS The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021. RESULTS Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; P noni nferiority =0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; P <0.0001). CONCLUSIONS The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.",2020,"Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77","['Results: Between December 14, 2015 and April 21, 2017', 'comers patient population treated with percutaneous coronary intervention', '1,572 patients, 1,966 lesions) or to the Orsiro stent (1,579 patients, 1,985 lesions', '3,151 patients']","['Polymer-Free Biolimus-Coated BioFreedom Stent with the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent', 'modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent', 'Percutaneous Coronary Intervention', 'BioFreedom stent']","['composite of cardiac death, myocardial infarction not related to any segment other than the target lesion or target lesion revascularization within 1 year, analyzed by intention-to-treat', 'target lesion revascularization', 'acute coronary syndromes', 'major adverse cardiovascular events (MACE']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}]",3151.0,0.23069,"Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77","[{'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Raungaard', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark (B.R., A.B.V., M.K.C., J.A., L.T., P.F., S.E.J.).'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Kahlert', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University, Denmark (J.K.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ellert', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Anton Boel', 'Initials': 'AB', 'LastName': 'Villadsen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark (B.R., A.B.V., M.K.C., J.A., L.T., P.F., S.E.J.).'}, {'ForeName': 'Karsten Tange', 'Initials': 'KT', 'LastName': 'Veien', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Steen Dalby', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Ahlehoff', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Carstensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Martin Kirk', 'Initials': 'MK', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark (B.R., A.B.V., M.K.C., J.A., L.T., P.F., S.E.J.).'}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstroem', 'Affiliation': ''}, {'ForeName': 'Knud Nørregaard', 'Initials': 'KN', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aaroe', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark (B.R., A.B.V., M.K.C., J.A., L.T., P.F., S.E.J.).'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thim', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark (B.R., A.B.V., M.K.C., J.A., L.T., P.F., S.E.J.).'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Freeman', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark (B.R., A.B.V., M.K.C., J.A., L.T., P.F., S.E.J.).'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Aziz', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Eftekhari', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Svend Eggert', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark (B.R., A.B.V., M.K.C., J.A., L.T., P.F., S.E.J.).'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Henrik Steen', 'Initials': 'HS', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.O.J., J.E., K.T.V., O.A., K.N.H., A.A., A.J., J.F.L., H.S.H.).'}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.040241'] 1558,32034028,"Effects of switching from a dipeptidyl peptidase-4 inhibitor to luseogliflozin on nocturnal blood pressure in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group comparison study.","INTRODUCTION Nocturnal hypertension is clinically important for patients with type 2 diabetes (T2D), considering its strong correlation with cardiovascular events. We aim to test the hypothesis that the sodium-glucose cotransporter 2 inhibitor, luseogliflozin, ameliorates nocturnal hypertension more effectively than a dipeptidyl peptidase (DPP)-4 inhibitor in patients with T2D. METHODS AND ANALYSIS This study is a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group trial. Sixty participants with T2D and hypertension who have been treated with a DPP-4 inhibitor for more than 4 weeks and who have a glycated haemoglobin A1c (HbA1c) level of 6.0%-9.0% will be randomised based on age, body mass index (BMI) and HbA1c to continue taking their DPP-4 inhibitor or to switch to luseogliflozin 2.5 mg once daily for 8 weeks. Twenty-four-hour ambulatory blood pressure monitoring (ABPM) will be performed twice at baseline and at the end of the study. All participants will continue their diet and exercise therapy, and the doses of concomitant medications will not be adjusted during the study. The primary endpoint is the effect of luseogliflozin on the mean change in systolic blood pressure (SBP) during the night, as measured by ABPM. The secondary endpoints are mean change in diastolic blood pressure (DBP) during the night, 24 hours of SBP and DBP, daytime SBP and DBP, pulse rate, BP M-value, trough SBP and DBP for 1 hour before the next dose, and other laboratory parameters. The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments. ETHICS AND DISSEMINATION The Ethics Review Board of Hokkaido University Hospital has approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBERS The University Hospital Medical Information Network (UMIN000031451); Japan Registry of Clinical Trials (jRCTs011180019); Pre-results.",2020,"The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments. ","['patients with T2D.\nMETHODS AND', 'patients with type 2 diabetes (T2D', 'Sixty participants with T2D and hypertension who have been treated with a DPP-4 inhibitor for more than 4 weeks and who have a glycated haemoglobin A1c (HbA1c) level of 6.0%-9.0% will be randomised based on age, body mass index (BMI) and HbA1c to continue taking their', 'patients with type 2 diabetes']","['sodium-glucose cotransporter 2 inhibitor, luseogliflozin', 'luseogliflozin', 'dipeptidyl peptidase-4 inhibitor to luseogliflozin', 'DPP-4 inhibitor or to switch to luseogliflozin 2.5\u2009mg once daily for 8 weeks']","['mean change in diastolic blood pressure (DBP) during the night, 24 hours of SBP and DBP, daytime SBP and DBP, pulse rate, BP M-value, trough SBP and DBP for 1\u2009hour before the next dose, and other laboratory parameters', 'ambulatory blood pressure monitoring (ABPM', 'mean change in systolic blood pressure (SBP', 'nocturnal blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",60.0,0.0678005,"The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments. ","[{'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Kawata', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeuchi', 'Affiliation': 'Sapporo Diabetes and Thyroid Clinic, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'So', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Centre, NTT East Corporation, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Division of Diabetes and Obesity, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan hmiyoshi@med.hokudai.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2019-034883'] 1559,16630091,An evaluation of the impact of oral magnesium lactate on the corrected QT interval of patients receiving sotalol or dofetilide to prevent atrial or ventricular tachyarrhythmia recurrence.,"BACKGROUND Intravenous magnesium reduces the QTc interval of patients receiving ibutilide. Whether oral magnesium can reduce the QTc interval associated with oral sotalol and dofetilide is not known. This study was undertaken to evaluate the impact of oral magnesium on the QTc interval and whether an inherent intracellular magnesium deficiency exists among patients with arrhythmias. METHODS Participants receiving sotalol or dofetilide for atrial or ventricular arrhythmias were randomized to receive magnesium l-lactate (504 mg elemental magnesium daily, Niche Pharmaceuticals, Roanoke, TX) or placebo for 48 hours. A 12-lead electrocardiogram (ECG) was obtained at baseline, 3 hours, and 51 hours after dosing to correspond to the Tmax after oral ingestion. The QTc interval was measured from the ECGs and compared between groups. Intracellular magnesium concentrations were determined by energy-dispersive x-ray analysis at baseline and 51 hours after dosing (Intracellular Diagnostics, Inc., Foster City, CA). RESULTS The QTc interval reductions from baseline were greater in the magnesium group than placebo at 3 and 51 hours (P = 0.015 and P < 0.001, respectively). Sixty-three percent of patients (regardless of experimental group) had baseline intracellular magnesium concentrations below the normal reference range of 33.9-41.9 mEq/IU, with an average level of 32.6 +/- 2.2 mEq/IU. CONCLUSIONS Oral magnesium l-lactate raises intracellular magnesium concentrations and lowers the QTc interval of patients receiving sotalol or dofetilide.",2006,"The QTc interval reductions from baseline were greater in the magnesium group than placebo at 3 and 51 hours (P = 0.015 and P < 0.001, respectively).","['patients receiving ibutilide', 'patients receiving sotalol or dofetilide to prevent atrial or ventricular tachyarrhythmia recurrence', 'patients with arrhythmias', 'Participants receiving sotalol or dofetilide for atrial or ventricular arrhythmias']","['placebo', 'oral magnesium lactate', 'oral magnesium', 'magnesium', 'magnesium l-lactate (504 mg elemental magnesium daily, Niche Pharmaceuticals, Roanoke, TX) or placebo']","['12-lead electrocardiogram (ECG', 'QTc interval reductions', 'Intracellular magnesium concentrations', 'QTc interval', 'baseline intracellular magnesium concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0082966', 'cui_str': 'ibutilide'}, {'cui': 'C0037707', 'cui_str': 'Sotalol'}, {'cui': 'C0114771', 'cui_str': 'dofetilide'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0042514', 'cui_str': 'Tachycardia, Ventricular'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0717900', 'cui_str': 'Magnesium lactate'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C1881354', 'cui_str': 'L-lactate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.242478,"The QTc interval reductions from baseline were greater in the magnesium group than placebo at 3 and 51 hours (P = 0.015 and P < 0.001, respectively).","[{'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'McBride', 'Affiliation': 'School of Pharmacy, University of Connecticut, Storrs, USA.'}, {'ForeName': 'Bokyung', 'Initials': 'B', 'LastName': 'Min', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kluger', 'Affiliation': ''}, {'ForeName': 'Danette', 'Initials': 'D', 'LastName': 'Guertin', 'Affiliation': ''}, {'ForeName': 'Nickole N', 'Initials': 'NN', 'LastName': 'Henyan', 'Affiliation': ''}, {'ForeName': 'Craig I', 'Initials': 'CI', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'Burton B', 'Initials': 'BB', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'White', 'Affiliation': ''}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",[] 1560,31845149,"Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men Who Have Sex with Men.","We sought to identify and compare correlates of condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (< 25 years) and older (≥ 25 years) Hispanic/Latino, black/African-American, and white men who have sex with men (MSM). Baseline data from the Evaluation of Rapid HIV Self-Testing among MSM Project (eSTAMP), a randomized controlled trial with MSM (n = 2665, analytical sample size = 2421), were used. Potential correlates included participants' sociodemographic characteristics and HIV status as well as the characteristics of participants' partners. Younger Hispanic/Latino and black men were most likely to report having older sex partners (≥ 50% of partners being at least 5 years older), and having older partners was a significant correlate of CRAI among younger Hispanic/Latino and white men. Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men. HIV prevention initiatives could address these and other correlates specific to race/ethnicity groups to target their prevention resources and messaging.",2020,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","['Hispanic/Latino, black/African-American, and white men who have sex with men (MSM', 'condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (<\u200925\xa0years) and older (≥\u200925\xa0years', 'Younger Hispanic/Latino and black men', 'Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men', 'n\u2009=\u20092665, analytical sample size\u2009=\u20092421', 'Who Have Sex with Men']","['MSM', 'MSM Project (eSTAMP']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",[],[],,0.04104,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA. ymizuno@cdc.gov.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Emory University School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}]",Archives of sexual behavior,['10.1007/s10508-019-01534-8'] 1561,31515632,Effects of New Zealand blackcurrant extract on sport climbing performance.,"PURPOSE Blood flow to skeletal muscles and removal of metabolic by-products during a sport climb are essential to optimise performance and recovery. New Zealand blackcurrant (NZBC) extract has enhanced blood flow and performance in other exercise modalities. We examined the effect of NZBC extract on sport climbing performance and recovery. METHODS The study employed a double-blind, randomised, crossover design. Male sport climbers (n = 18, age 24 ± 6 years, height 179 ± 6 cm, mass 71.4 ± 7.8 kg, French grade 6a-8b) undertook 7 days supplementation of NZBC extract (600 mg day -1 CurraNZ™ containing 210 mg anthocyanins) or a placebo (PL). Climbing ability was assessed through hang time (HT), pull-ups and total climbing time (TCT) in 3 intermittent climbing bouts on a Treadwall M6 rotating climbing wall to exhaustion with 20 min recovery between climbs. Heart rate (HR), blood lactate (BL), forearm girth (FG) and hand grip strength (HGS) were recorded. RESULTS NZBC extract had no effect on pull-ups but provided a trend for higher HT and significantly improved TCT (+23%) compared to PL (-11%) over three climbs. HR, BL, FG and HGS all indicated that 20 min was insufficient for physiological recovery between the three climbing bouts indicating accumulative fatigue regardless of supplement condition. CONCLUSION Despite indices of progressive fatigue across three bouts of climbing, NZBC extract facilitated not only a maintenance of TCT but an improved climbing endurance as compared with the PL condition. Blackcurrant anthocyanin-derived metabolites seem to affect physiological responses that facilitate sport climbing performance.",2020,NZBC extract had no effect on pull-ups but provided a trend for higher HT and significantly improved TCT (+23%) compared to PL (-11%) over three climbs.,"['Male sport climbers (n\u2009=\u200918, age 24\u2009±\u20096\xa0years, height 179\u2009±\u20096\xa0cm, mass 71.4\u2009±\u20097.8\xa0kg, French grade 6a-8b) undertook 7\xa0days supplementation of']","['NZBC extract', 'New Zealand blackcurrant extract', 'placebo (PL', 'New Zealand blackcurrant (NZBC) extract', 'NZBC extract (600\xa0mg\xa0day -1 CurraNZ™ containing 210\xa0mg anthocyanins']","['climbing endurance', 'HR, BL', 'TCT', 'Climbing ability', 'hang time (HT), pull-ups and total climbing time (TCT', 'pull-ups', 'Heart rate (HR), blood lactate (BL), forearm girth (FG) and hand grip strength (HGS', 'sport climbing performance', 'blood flow and performance']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Black Currant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}]","[{'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",,0.382105,NZBC extract had no effect on pull-ups but provided a trend for higher HT and significantly improved TCT (+23%) compared to PL (-11%) over three climbs.,"[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Potter', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester, PO19 6PE, UK. j.potter@chi.ac.uk.'}, {'ForeName': 'C I', 'Initials': 'CI', 'LastName': 'Hodgson', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester, PO19 6PE, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Broadhurst', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester, PO19 6PE, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Howell', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester, PO19 6PE, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester, PO19 6PE, UK.'}, {'ForeName': 'M E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester, PO19 6PE, UK.'}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Perkins', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester, PO19 6PE, UK.'}]",European journal of applied physiology,['10.1007/s00421-019-04226-2'] 1562,32101915,A Randomized Controlled Trial on Optimal Sampling Sequence in Radial Guide Sheath Endobronchial Ultrasound Lung Biopsy.,"BACKGROUND An optimal sampling sequence in radial guide sheath endobronchial ultrasound lung biopsy (R-EBUS) is unclear. This prospective single-center pilot randomized controlled trial aimed to determine if the initial method and sequence of sampling affect the diagnostic accuracy of the procedure. METHODS Consecutive patients undergoing R-EBUS for lesions >15 mm with a bronchus sign were randomly assigned (1:1:1) to biopsy first (group A), brushings first (group B) or combination (group C). The primary outcome was a positive diagnosis from any sampling method. RESULTS Fifty-four patients were randomized. The overall diagnostic yield of the procedure was 77.8% (95% confidence interval: 66%-89%), with no difference between groups. A higher rate of positive cytology from brushings was seen if the biopsies were performed before brushings (77.8% in group A vs. 44.4% in group B, P=0.03). The rate of positive cytology from washings was higher if the washings were obtained just after the brushings (61.1% in group A vs. 11.1% in group B, P=0.02). There was no difference in the rate of positive biopsy histology in the groups (P=0.27). All 3 sampling modalities were more likely to be positive in group A (50.0% vs. 11.1% in group B and 22.2% in group C, P=0.04). Complications rate was low and not significantly different between groups. CONCLUSION The overall rate of a positive R-EBUS procedure was not affected by the initial sampling method or sequence. However, all 3 sampling modalities were more likely to be positive if biopsies were performed first, followed by brushings and washings.",2020,"The overall diagnostic yield of the procedure was 77.8% (95% confidence interval: 66%-89%), with no difference between groups.","['Consecutive patients undergoing R-EBUS for lesions >15\u2009mm with a bronchus sign', 'Fifty-four patients were randomized']",[],"['rate of positive biopsy histology', 'positive diagnosis from any sampling method', 'overall diagnostic yield', 'rate of positive cytology', 'Complications rate', 'rate of positive cytology from washings', 'overall rate of a positive R-EBUS procedure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0006255', 'cui_str': 'Bronchi'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",54.0,0.230392,"The overall diagnostic yield of the procedure was 77.8% (95% confidence interval: 66%-89%), with no difference between groups.","[{'ForeName': 'Chinthaka B', 'Initials': 'CB', 'LastName': 'Samaranayake', 'Affiliation': 'Department of Respiratory Medicine, Sunshine Coast University Hospital, Sunshine Coast.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Department of Respiratory Medicine, Sunshine Coast University Hospital, Sunshine Coast.'}, {'ForeName': 'Shiv', 'Initials': 'S', 'LastName': 'Erigadoo', 'Affiliation': 'Department of Respiratory Medicine, Sunshine Coast University Hospital, Sunshine Coast.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Azzopardi', 'Affiliation': 'Department of Respiratory Medicine, Sunshine Coast University Hospital, Sunshine Coast.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Putt', 'Affiliation': 'Department of Respiratory Medicine, Sunshine Coast University Hospital, Sunshine Coast.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bint', 'Affiliation': 'Department of Respiratory Medicine, Sunshine Coast University Hospital, Sunshine Coast.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000651'] 1563,31285591,Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial).,"BACKGROUND Chemotherapy with biologics followed by liver surgery improves the resection rate and survival of patients with colorectal liver metastasis (CRLM). However, no prospective study has compared the outcomes of chemotherapy with bevacizumab (BEV) versus cetuximab (CET). METHODS The ATOM study is the first randomised trial comparing BEV and CET for initially unresectable CRLM. Patients were randomly assigned in a 1:1 ratio to receive mFOLFOX6 plus either BEV or CET. The primary endpoint was progression-free survival (PFS). RESULTS Between May 2013 and April 2016, 122 patients were enrolled. Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33). Patients with a smaller-number but larger-sized metastases did better in the CET group. In the BEV and CET groups, the response rates were 68.4% and 84.7% and the resection rates were 56.1% and 49.2%, respectively. CONCLUSION Although CET achieved a better response rate than BEV for patients with a small number of large liver metastases, both biologics had similar efficacy regarding liver resection and acceptable safety profiles. To achieve optimal PFS, biologics should be selected in accordance with patient conditions. TRIAL REGISTRATION This trial is registered at ClinicalTrials.gov (number NCT01836653), and UMIN Clinical Trials Registry (UMIN-CTR number UMIN000010209).",2019,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"['Between May 2013 and April 2016, 122 patients were enrolled', 'patients with colorectal liver metastasis (CRLM']","['mFOLFOX6 plus either BEV or CET', 'CET', 'mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab', 'chemotherapy with bevacizumab (BEV) versus cetuximab (CET']","['progression-free survival (PFS', 'resection rates', 'response rates', 'response rate', 'resection rate and survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",122.0,0.166579,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. okieiji@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Emi', 'Affiliation': 'Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hatano', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ojima', 'Affiliation': 'Department of Surgery, Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Department of Surgery, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Surgery, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Katayose', 'Affiliation': 'Department of Hepatobiliary and Pancreatic, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Divison of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.'}]",British journal of cancer,['10.1038/s41416-019-0518-2'] 1564,31810797,"Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study.","BACKGROUND Treatment for renal cell carcinoma has been revolutionised by inhibitors of VEGF receptor. Previous studies have suggested that treatment with a VEGF receptor (VEGFR) tyrosine kinase inhibitor might be effective in patients who had previous checkpoint inhibitor therapy. Therefore, TIVO-3 was designed to compare the efficacy and safety of tivozanib (a potent and selective VEGFR inhibitor) with those of sorafenib as third-line or fourth-line therapy in patients with metastatic renal cell carcinoma. METHODS In this open-label, randomised, controlled trial done at 120 academic hospitals in 12 countries, we enrolled eligible patients older than 18 years with histologically or cytologically confirmed metastatic renal cell carcinoma and at least two previous systemic treatments (including at least one previous treatment with a VEGFR inhibitor), measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were excluded if they had received previous treatment with tivozanib or sorafenib. Patients were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy and randomised (1:1) with a complete permuted block design (block size of four) to either tivozanib 1·5 mg orally once daily in 4-week cycles or sorafenib 400 mg orally twice daily continuously. Investigators and patients were not masked to treatment. The primary endpoint was progression-free survival by independent review in the intention-to-treat population. Safety analyses were done in all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT02627963. FINDINGS Between May 24, 2016, and Aug 14, 2017, 350 patients were randomly assigned to receive tivozanib (175 patients) or sorafenib (175 patients). Median follow-up was 19·0 months (IQR 15·0-23·4). Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016). The most common grade 3 or 4 treatment-related adverse event was hypertension (35 [20%] of 173 patients treated with tivozanib and 23 [14%] of 170 patients treated with sorafenib). Serious treatment-related adverse events occurred in 19 (11%) patients with tivozanib and in 17 (10%) patients with sorafenib. No treatment-related deaths were reported. INTERPRETATION Our study showed that tivozanib as third-line or fourth-line therapy improved progression-free survival and was better tolerated compared with sorafenib in patients with metastatic renal cell carcinoma. FUNDING AVEO Oncology.",2020,"Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016).","['patients with advanced renal cell carcinoma (TIVO-3', 'patients who had previous checkpoint inhibitor therapy', 'renal cell carcinoma', 'Between May 24, 2016, and Aug 14, 2017, 350 patients', 'patients with metastatic renal cell carcinoma', '120 academic hospitals in 12 countries, we enrolled eligible patients older than 18 years with histologically or cytologically confirmed metastatic renal cell carcinoma and at least two previous systemic treatments (including at least one previous treatment with a VEGFR inhibitor), measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'Patients were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy and randomised (1:1) with a complete permuted block design (block size of four) to either']","['VEGF receptor (VEGFR) tyrosine kinase inhibitor', 'tivozanib', 'tivozanib 1·5 mg orally once daily in 4-week cycles or sorafenib 400 mg orally twice daily continuously', 'sorafenib', 'Tivozanib versus sorafenib', 'tivozanib or sorafenib']","['adverse events', 'progression-free survival', 'efficacy and safety', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2827667', 'cui_str': 'tivozanib'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",350.0,0.273877,"Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016).","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA. Electronic address: rinib2@ccf.org.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Kidney Cancer Program, City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Escudier', 'Affiliation': 'Department of Oncology Medicine, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Department of Medical Oncology, Georgetown Lombardi University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Urologic Oncology, Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia Chief, Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verzoni', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Needle', 'Affiliation': 'AVEO Oncology, Cambridge, MA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30735-1'] 1565,30010228,Interplay Between Sensation Seeking and Parental Rules in the Emergence of Heavy Episodic Drinking.,"This study examined the parallel mediational processes between sensation seeking and parental rules on alcohol, in the emergence of heavy episodic drinking (HED) in adolescents. Data were drawn from a U.K. clustered randomized control trial (control arm only, N ≈ 6,300, M age at baseline = 12.5). Using parallel process latent growth curve analysis, stricter parental rules at baseline were found to be associated with greater declines in sensation seeking over time and a lower risk of HED at follow-up (+33 months). Higher initial levels of sensation seeking predicted a faster relaxation of parental rules and a greater risk of HED. By maintaining strict rules about alcohol, parents may promote a positive reduction in sensation seeking and a lower risk of HED.",2019,Higher initial levels of sensation seeking predicted a faster relaxation of parental rules and a greater risk of HED.,['heavy episodic drinking (HED) in adolescents'],[],['risk of HED'],"[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0177105,Higher initial levels of sensation seeking predicted a faster relaxation of parental rules and a greater risk of HED.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Percy', 'Affiliation': ""Queen's University Belfast.""}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McKay', 'Affiliation': 'University of Liverpool.'}, {'ForeName': 'Jon C', 'Initials': 'JC', 'LastName': 'Cole', 'Affiliation': 'University of Liverpool.'}]",Journal of research on adolescence : the official journal of the Society for Research on Adolescence,['10.1111/jora.12435'] 1566,31806543,"Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial.","BACKGROUND Denosumab is a fully human monoclonal antibody that binds to, and inhibits, the receptor activator of RANKL (TNFSF11) and might affect breast cancer biology, as shown by preclinical evidence. We aimed to assess whether denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments would increase bone metastasis-free survival in women with breast cancer. METHOD In this international, double-blind, randomised, placebo-controlled, phase 3 study (D-CARE), patients were recruited from 389 centres in 39 countries. We enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1. On eligibility confirmation, investigators at each site telephoned an interactive voice response system to centrally randomly assign patients (1:1) based on a fixed stratified permuted block randomisation list (block size 4) to receive either denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy, for about 6 months and then every 12 weeks for a total duration of 5 years. Stratification factors were breast cancer therapy, lymph node status, hormone receptor and HER2 status, age, and geographical region. The primary endpoint was the composite endpoint of bone metastasis-free survival. This trial is registered with ClinicalTrials.gov, NCT01077154. FINDINGS Between June 2, 2010, and Aug 24, 2012, 4509 women were randomly assigned to receive denosumab (n=2256) or placebo (n=2253) and included in the intention-to-treat analysis. The primary analysis of the study was done when all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017. The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70). The most common grade 3 or worse treatment-emergent adverse events, reported in patients who had at least one dose of the investigational product (2241 patients with denosumab vs 2218 patients with placebo), were neutropenia (340 [15%] vs 328 [15%]), febrile neutropenia (112 [5%] vs 142 [6%]), and leucopenia (62 [3%] vs 61 [3%]). Positively adjudicated osteonecrosis of the jaw occurred in 122 (5%) of 2241 patients treated with denosumab versus four (<1%) of 2218 patients treated with placebo; treatment-emergent hypocalcaemia occurred in 152 (7%) versus 82 (4%). Two treatment-related deaths occurred in the placebo group due to acute myeloid leukaemia and depressed level of consciousness. INTERPRETATION Despite preclinical evidence suggesting RANKL inhibition might delay bone metastasis or disease recurrence in patients with early-stage breast cancer, in this study, denosumab did not improve disease-related outcomes for women with high-risk early breast cancer. FUNDING Amgen.",2020,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","['enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'women with breast cancer', 'patients with early-stage breast cancer', 'all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017', 'early breast cancer (D-CARE', 'Between June 2, 2010, and Aug 24, 2012, 4509 women', 'patients were recruited from 389 centres in 39 countries', 'women with high-risk early breast cancer']","['Adjuvant denosumab', 'placebo', 'denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy', 'denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments', 'denosumab']","['febrile neutropenia', 'bone metastasis-free survival', 'deaths', 'acute myeloid leukaemia and depressed level of consciousness', 'neutropenia', 'composite endpoint of bone metastasis-free survival', 'emergent hypocalcaemia', 'leucopenia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0549249', 'cui_str': 'Depressed Level of Consciousness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",2218.0,0.71545,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK. Electronic address: r.e.coleman@sheffield.ac.uk.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Finkelstein', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nayoya, Japan.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Hospital Pérola Byington and Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'UCLA School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Alvaro Montaño', 'Initials': 'AM', 'LastName': 'Periañez', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Tonkin', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Deleu', 'Affiliation': 'Oncology Center, AZ Nikolass, Sint-Niklaas, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Crown', 'Affiliation': 'All-Ireland Co-Operative Oncology Research Group, Dublin, Ireland.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Dai', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Jandial', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre Western Australia and School of Medicine, Curtin University, Perth, WA, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30687-4'] 1567,31512050,"Effectiveness of a brief psychotherapeutic intervention compared with treatment as usual for adolescent nonsuicidal self-injury: a single-centre, randomised controlled trial.","Although nonsuicidal self-injury (NSSI) is a clinically significant behavior, evidence-based, specific, time-, and cost-effective treatment approaches are lacking. The aim of this study was to compare the efficacies of a brief cognitive-behavioral psychotherapy manual, the Cutting Down Programme (CDP), and treatment as usual (TAU) in the treatment of adolescent NSSI. We conducted a single-centre randomised controlled trial (RCT). Eligible participants were aged 12-17 years engaging in repetitive NSSI (at least 5 times within the past 6 months). We randomly allocated 74 participants to CDP (n = 37) or TAU (n = 37; in a 1:1 ratio). Outcome measures were administered before treatment (T0), directly after CDP or 4 months after baseline evaluation in the TAU group (T1), and another 6 months later (T2; primary endpoint). Primary outcome was a 50% reduction in NSSI frequency within the past 6 months at 10-month follow-up (T2). Regarding the primary outcome, there were no significant differences between the CDP (n = 26; 70.3%) and TAU group [n = 27; 73.0%; χ 2 (1) = 0.07; p = 0.797]; NSSI frequency within the past 6 months was significantly reduced at T2 [χ 2 (1) = 12.45; p < 0.001] with no between-group difference [χ 2 (1) = 0.14; p = 0.704]. However, we found a significant group x point of measurement interaction [χ 2 (2) = 7.78; p = 0.021] regarding NSSI within the last month indicating at T1. CDP was equally effective and achieved faster recovery compared to a significantly more intensive TAU in treating adolescent NSSI. The CDP could provide a brief and pragmatic first treatment within a stepped-care model for NSSI in routine clinical care.Clinical Trial Registration The trial was prospectively registered in the German Registry of Clinical Trials (https://www.drks.de; DRKS00003605) and is now complete.",2020,Primary outcome was a 50% reduction in NSSI frequency within the past 6 months at 10-month follow-up (T2).,"['adolescent NSSI', 'Eligible participants were aged 12-17\xa0years engaging in repetitive NSSI', 'adolescent nonsuicidal self-injury']","['CDP', 'TAU', 'cognitive-behavioral psychotherapy manual, the Cutting Down Programme (CDP', 'psychotherapeutic intervention']",['NSSI frequency'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}]","[{'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",74.0,0.188995,Primary outcome was a 50% reduction in NSSI frequency within the past 6 months at 10-month follow-up (T2).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kaess', 'Affiliation': 'University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern, Stöckli, Bolligenstrasse 141c, 3000, Bern 60, Switzerland. michael.kaess@upd.ch.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Edinger', 'Affiliation': 'Section for Translational Psychobiology in Child and Adolescent Psychiatry, Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Fischer-Waldschmidt', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Parzer', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Romuald', 'Initials': 'R', 'LastName': 'Brunner', 'Affiliation': 'Clinic and Policlinic of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Regensburg, Regensburg District Hospital, Regensburg, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Resch', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01399-1'] 1568,31759471,A pilot study to examine the feasibility and acceptability of a coordinated intervention design to address treatment engagement challenges in school mental health services.,"Treatment engagement is a significant challenge in school mental health services. Despite a growing evidence base on effective interventions for treatment engagement, attempts to address these challenges rarely leverage the available relevant research. To close this gap, this pilot study examined the feasibility, acceptability, and initial implementation outcomes of a coordinated knowledge system (CKS) designed to support the efforts of school mental health (SMH) professionals to address treatment engagement challenges. A sample of four supervisors and their supervisees (n = 17) with master's of social work degrees serving youth within an urban SMH program were randomly assigned to either (a) a CKS condition that offered a unified set of resources to structure decisions about treatment engagement or (b) a survey plus practice guidelines (SPG) condition, in which resources were provided without an explicit model for their coordinated use. Feasibility was assessed quantitatively, acceptability was assessed quantitatively and qualitatively, and initial implementation outcomes were evaluated using a behavioral observation coding system. Results provided strong support for the feasibility and acceptability of the study design, instrumentation, and interventions. It appears that the CKS can be feasibly implemented with good acceptability. Patterns of initial implementation strongly suggested that, relative to the SPG, the CKS supports identification of engagement problems as well as intervention selection and planning. Findings also identified modifications to study procedures that would be necessary in a future study. A larger trial using similar methodology and instrumentation could yield important findings about the effectiveness of the CKS in clinical practice and could articulate the mechanisms by which it operates.",2019,"To close this gap, this pilot study examined the feasibility, acceptability, and initial implementation outcomes of a coordinated knowledge system (CKS) designed to support the efforts of school mental health (SMH) professionals to address treatment engagement challenges.","[""A sample of four supervisors and their supervisees (n\u202f=\u202f17) with master's of social work degrees serving youth within an urban SMH program"", 'school mental health services']","['coordinated knowledge system (CKS', 'CKS', 'CKS condition that offered a unified set of resources to structure decisions about treatment engagement or (b) a survey plus practice guidelines (SPG) condition, in which resources were provided without an explicit model for their coordinated use']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0936005', 'cui_str': 'Practice Guideline'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",[],,0.0207747,"To close this gap, this pilot study examined the feasibility, acceptability, and initial implementation outcomes of a coordinated knowledge system (CKS) designed to support the efforts of school mental health (SMH) professionals to address treatment engagement challenges.","[{'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, University of South Carolina, 1512 Pendleton Street, Columbia, SC 29208, United States of America. Electronic address: beckerkd@mailbox.sc.edu.'}, {'ForeName': 'Alayna L', 'Initials': 'AL', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Franz Hall, Los Angeles, CA 90095, United States of America.'}, {'ForeName': 'Maya M', 'Initials': 'MM', 'LastName': 'Boustani', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Franz Hall, Los Angeles, CA 90095, United States of America.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Franz Hall, Los Angeles, CA 90095, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2019.07.013'] 1569,31513531,Comparing the effects of cold compress and Xyla-p cream on hemodynamic changes in hemodialysis patients during venipuncture.,"Background The vital signs reflect the physiological state of patients in various clinical conditions. The purpose of this study was to compare the effects of cold compress and Xyla-P cream on hemodynamical changes during venipuncture in hemodialysis patients. Methods and Material In this clinical trial study, 50 patients under hemodialysis were selected by simple random sampling. The patients were then randomly assigned to either Xyla-P cream, cold compress or placebo groups. The vital signs (blood pressure and pulse) were measured upon two intermittent hemodialysis sessions before and after venipuncture. Data were analyzed using repeated measures analysis of variance. Results The mean alternation in systolic blood pressure was significantly different comparing the placebo and cold compress groups before and after intervention (p<0.001). However, the difference was not significant between the Xyla-P cream group and either placebo (p=0.402) or ice compress (p=0.698) groups. The difference of the mean diastolic blood pressure was significant comparing the placebo group with either the Xyla-P cream group (p=0.003) or cold compress group (p<0.001) before and after intervention. In addition, there was a significant difference in the mean number of heartbeats comparing the control group with either the Xyla-P cream group (p<0.001) or cold compress group (p<0.001) before and after the intervention. Conclusions Considering the beneficial effects of ice compress and the Xyla-P cream on reduction of cardiovascular parameters, it is recommended to use these methods in hemodialysis patients during venipuncture.",2019,The difference of the mean diastolic blood pressure was significant comparing the placebo group with either the Xyla-P cream group (p=0.003) or cold compress group (p<0.001) before and after intervention.,"['50 patients under hemodialysis were selected by simple random sampling', 'hemodialysis patients during venipuncture', 'hemodialysis patients']","['Xyla-P cream,\xa0cold compress or placebo', 'Xyla-P cream', 'placebo', 'cold compress and Xyla-p cream', 'cold\xa0compress and Xyla-P cream']","['hemodynamic changes', 'vital signs (blood pressure and pulse', 'hemodynamical changes', 'mean diastolic blood pressure', 'mean alternation in systolic blood pressure', 'mean number of heartbeats']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0919661', 'cui_str': 'Heart alternation'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",50.0,0.035888,The difference of the mean diastolic blood pressure was significant comparing the placebo group with either the Xyla-P cream group (p=0.003) or cold compress group (p<0.001) before and after intervention.,"[{'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Ghoreyshi', 'Affiliation': 'Shohada Hospital, Mashhad University of Medical Sciences, Quchan, Iran (Islamic Republic of).'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Amerian', 'Affiliation': 'Clinical Research Development Unit, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran (Islamic Republic of).'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Amanpour', 'Affiliation': 'Clinical Research Development Unit, Bahar Hospital, Shahroud University of Medical Sciences, Shahroud, Iran (Islamic Republic of).'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Randomized Controlled Trial Research Center, Shahroud University of Medical Sciences, 7th Sq., Shahroud, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0154'] 1570,31602689,Reducing the Biological and Psychological Toxicity of Poverty-related Stress: Initial Efficacy of the BaSICS Intervention for Early Adolescents.,"This proof-of-concept study tests the initial efficacy of the Building a Strong Identity and Coping Skills (BaSICS) intervention, a selective prevention of internalizing problems program for early adolescents exposed to high levels of poverty-related stress. Eighty-four early adolescents (M age  = 11.36 years) residing in very low-income neighborhoods were randomized to receive the 16-session intervention (n = 44) or to an assessment-only control condition (n = 40). BaSICS teaches coping skills, social identity development, and collective social action to empower youth with the ability to connect with members of their communities and cope with poverty-related stress in positive and collaborative ways. Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping. In addition, HPA reactivity was significantly reduced in the intervention youth, but not controls. Finally, intervention youth's internalizing and somatic symptoms as reported by both youth and their parents, showed significant reductions over time, whereas control youth had no such changes. Results provide strong support for this approach to strength-building and symptom reduction in a population of early adolescents exposed to poverty-related stress.",2020,Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping.,"['Early Adolescents', '11.36\xa0years) residing in very low-income neighborhoods', 'early adolescents exposed to high levels of poverty-related stress', 'Eighty-four early adolescents (M age \xa0']","['Building a Strong Identity and Coping Skills (BaSICS) intervention', '16-session intervention (n\xa0=\xa044) or to an assessment-only control condition', 'BaSICS Intervention']","['HPA reactivity', 'problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring (regime/therapy)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",84.0,0.0212825,Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping.,"[{'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Wadsworth', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Celina M', 'Initials': 'CM', 'LastName': 'Joos', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jarl A', 'Initials': 'JA', 'LastName': 'Ahlkvist', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Sarah E D', 'Initials': 'SED', 'LastName': 'Perzow', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Emile M', 'Initials': 'EM', 'LastName': 'Tilghman-Osborne', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Creavey', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Brelsford', 'Affiliation': 'Penn State University Harrisburg, Middletown, PA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12400'] 1571,31498308,Home-Based Prescribed Pulmonary Exercise in Patients with Stable Chronic Obstructive Pulmonary Disease.,"As a systemic disease, chronic obstructive pulmonary disease (COPD) affects the respiratory system, inducing restless and exercise dyspnea. It also impacts exercise capacity and forms a vicious circle in which it further aggravates the condition of patients and accelerates disease progression. As a functional holistic exercise, traditional Chinese exercises (TCE) play an important role in the rehabilitation of COPD on the basis of adjusting the breath and performing coordinated movements. This study investigates the effects of prescribed pulmonary exercises (which are modified from TCE) on exercise capacity of upper and lower limbs, endurance exercise capacity, and quality of life in stable COPD patients. The goal is to determine the accessibility of these prescribed exercises in COPD rehabilitation. Participants are randomly divided into a non-exercise control group (CG) or prescribed pulmonary exercise group (PG) at a ratio of 1: 1. The PG receives intervention for 60 min twice per day, 7 days a week, for a total of 3 months. The intensity is measured using the Borg category-ratio 10 scale and with a heart-rate monitor. Then, an exercise capacity test and quality of life questionnaire are scheduled at 1 week before and after the formal intervention. After 3 months of intervention, the 30 s arm curl test, 30 s sit-to-stand test, 6 min walking test, and quality of life show significant improvement in COPD patients (p < 0.05). These findings indicate that prescribed pulmonary exercises can be applied as alternative, convenient, and effective home- and community-based exercises for stable COPD patients.",2019,"After 3 months of intervention, the 30 s arm curl test, 30 s sit-to-stand test, 6 min walking test, and quality of life show significant improvement in COPD patients (p < 0.05).","['Patients with Stable Chronic Obstructive Pulmonary Disease', 'stable COPD patients']","['Home-Based Prescribed Pulmonary Exercise', 'non-exercise control group (CG) or prescribed pulmonary exercise group (PG', 'prescribed pulmonary exercises (which are modified from TCE', 'functional holistic exercise, traditional Chinese exercises (TCE']","['exercise capacity test and quality of life questionnaire', 'exercise capacity of upper and lower limbs, endurance exercise capacity, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]",,0.0226112,"After 3 months of intervention, the 30 s arm curl test, 30 s sit-to-stand test, 6 min walking test, and quality of life show significant improvement in COPD patients (p < 0.05).","[{'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine; Institute of Rehabilitation Medicine, Shanghai Academy of Traditional Chinese Medicine.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Yufan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Shan', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine; Institute of Rehabilitation Medicine, Shanghai Academy of Traditional Chinese Medicine; tcm4463@outlook.com.'}, {'ForeName': 'Weibing', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport; wwb75@126.com.'}]",Journal of visualized experiments : JoVE,['10.3791/59765'] 1572,32043630,Changes in skin barrier function following single and repeated applications of 4 types of moisturizers: a randomized controlled trial.,,2020,"Here, we compared the effect of 4 types of moisturizers containing humectant (A), occlusive (B), ceramide (C) and hydrating (D) ingredients on healthy skin barrier function, after single application as well as after two weeks of repeated use (table 1).",['4 types of moisturizers'],"['moisturizers containing humectant (A), occlusive (B), ceramide (C) and hydrating (D) ingredients']","['skin barrier function', 'healthy skin barrier function']","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2936383', 'cui_str': 'Humectants'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.116952,"Here, we compared the effect of 4 types of moisturizers containing humectant (A), occlusive (B), ceramide (C) and hydrating (D) ingredients on healthy skin barrier function, after single application as well as after two weeks of repeated use (table 1).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samadi', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ahmad Nasrollahi', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maghsoudi Ashtiani', 'Affiliation': 'Pharmaceutical sciences branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Abels', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Firooz', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16288'] 1573,31455090,"""You must leave but I didn't want to leave"": qualitative evaluation of the integration of ART into postnatal maternal and child health services in Cape Town, South Africa.","Postpartum HIV care retention rates are well below retention rates of the general adult population. The Maternal-Child Health Antiretroviral Therapy (MCH-ART) trial tested the benefit of integrating postpartum maternal ART and pediatric care through the end of breastfeeding compared to the standard of care of immediate postpartum referral of mother and infant to separate services. After the trial, twenty-one participants completed in-depth interviews to understand the acceptability of the service integration and the potentially differing ""lived"" experiences of the women randomized to the two conditions. Key findings include: (1) the MCH-ART integrated service was found to be acceptable, (2) women in the intervention condition expressed more negative feelings around the need to be transferred to general ART services and (3) women in the intervention condition perceived that they had more influence in selecting the clinic to which they would be transferred compared to those in the control group, although there was no actual difference by study design. Future work should more directly evaluate the impact of shared decision-making and long-term relationships with clinic staff on patient engagement and retention in HIV care.",2020,"Key findings include: (1) the MCH-ART integrated service was found to be acceptable, (2) women in the intervention condition expressed more negative feelings around the need to be transferred to general ART services and (3) women in the intervention condition perceived that they had more influence in selecting the clinic to which they would be transferred compared to those in the control group, although there was no actual difference by study design.",[],[],['negative feelings'],[],[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",21.0,0.0861463,"Key findings include: (1) the MCH-ART integrated service was found to be acceptable, (2) women in the intervention condition expressed more negative feelings around the need to be transferred to general ART services and (3) women in the intervention condition perceived that they had more influence in selecting the clinic to which they would be transferred compared to those in the control group, although there was no actual difference by study design.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Pellowski', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Alison Z', 'Initials': 'AZ', 'LastName': 'Weber', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Tamsin K', 'Initials': 'TK', 'LastName': 'Phillips', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brittain', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zerbe', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}]",AIDS care,['10.1080/09540121.2019.1659913'] 1574,31382171,"Omega-3-polyunsatured fatty acids (O3PUFAs), compared to placebo, reduced symptoms of occupational burnout and lowered morning cortisol secretion.","BACKGROUND Occupational burnout is both a serious health concern at both public and individual levels. Treatment options are psychopharmacological, psychological and physical activity-related interventions. Here, we tested whether, compared to placebo, omega-3-polyunsaturated fatty acids (O3PUFAs) have a positive impact on burnout and morning cortisol secretion. METHOD A total of 43 individuals (mean age: 38.4 years, 76.7% females) took part in the present double-blind and placebo-controlled intervention. Participants were randomly assigned either to the O3PUFA or to the placebo condition. At baseline and again eight weeks later, participants completed the Maslach Burnout Inventory and collected morning saliva samples for analysis of the cortisol awakening response (CAR). RESULTS Emotional exhaustion and depersonalization decreased, and sense of personal accomplishment increased over time, but more so in the O3PUFA condition than in the placebo condition. Likewise, CAR decreased over time, but again more so in the O3PUFA condition than in the placebo condition. CONCLUSIONS The present pattern of results suggests that, compared to placebo, administration of daily omega-3-polyunsaturated fatty acids for eight consecutive weeks positively influences both psychological and physiological markers of occupational burnout.",2019,"Likewise, CAR decreased over time, but again more so in the O3PUFA condition than in the placebo condition. ","['43 individuals (mean age: 38.4 years, 76.7% females) took part in the present double-blind and']","['Omega-3-polyunsatured fatty acids (O3PUFAs', 'placebo-controlled intervention', 'placebo', 'O3PUFA', 'placebo, omega-3-polyunsaturated fatty acids (O3PUFAs']","['Emotional exhaustion and depersonalization decreased, and sense of personal accomplishment', 'symptoms of occupational burnout and lowered morning cortisol secretion', 'cortisol awakening response (CAR']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006433', 'cui_str': 'Career Burnout'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}]",43.0,0.270199,"Likewise, CAR decreased over time, but again more so in the O3PUFA condition than in the placebo condition. ","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Jahangard', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical sciences, Hamadan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical sciences, Hamadan, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Abbasalipourkabir', 'Affiliation': 'Department of Biochemistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ahmadpanah', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faryadras', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Mikoteit', 'Affiliation': 'University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; University of Basel, Psychiatric Hospital Solothurn, Solothurn, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Isfahan University of Medical Sciences, Neurosciences Research Center, Alzahra Research Institute, Isfahan, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland. Electronic address: serge.brand@upk.ch.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104384'] 1575,31800067,Association of β-Blocker Use With Heart Failure Hospitalizations and Cardiovascular Disease Mortality Among Patients With Heart Failure With a Preserved Ejection Fraction: A Secondary Analysis of the TOPCAT Trial.,"Importance β-Blockers are prescribed to most patients with heart failure (HF) with a preserved ejection fraction (HFpEF), but their effect on HFpEF remains unclear. Objective To determine the association of β-blocker use with HF hospitalizations and cardiovascular disease (CVD) mortality, overall and in strata of patients with an ejection fraction (EF) of 50% or greater or less than 50%. Design, Setting, and Participants For 1761 participants from North and South America enrolled in the multicenter, double-blinded Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist randomized clinical trial of spironolactone for patients with HFpEF between August 10, 2006, and January 31, 2012, the association of baseline β-blocker use with HF hospitalization and CVD mortality was analyzed using unadjusted and adjusted Cox proportional hazards regression models, overall and in strata of patients with an EF of 50% or greater or less than 50%. Participants had symptomatic HF with a left ventricular EF of 45% or greater, with enrollment based on either hospitalization attributed to decompensated HF in the prior year or elevated natriuretic peptide levels. Statistical analysis was performed from January 31 to May 2, 2019. Exposure Use of β-blockers. Main Outcomes and Measures Incident HF hospitalization and CVD mortality. Results Among 1761 participants included in the analysis (879 women and 882 men; mean [SD] age, 71.5 [9.6] years), 1394 (79.2%) reported β-blocker use and 1567 (89.0%) had an EF of 50% or greater. Hospitalizations for HF occurred for 399 participants (22.7%), and CVD mortality occurred for 229 participants (13.0%). Use of β-blockers was associated with a higher risk of HF hospitalization among patients with HFpEF with an EF of 50% or greater (hazard ratio, 1.74 [95% CI, 1.28-2.37]; P < .001) but not among patients with an EF between 45% and 49% (hazard ratio, 0.68 [95% CI, 0.28-1.63]; P = .39). There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03). Use of β-blockers was not associated with a change in CVD mortality. Conclusions and Relevance For patients with an EF of 50% or greater, β-blocker use was associated with an increased risk of HF hospitalizations but not CVD mortality. For patients with an EF between 45% and 49%, there was no such association.",2019,There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03).,"['patients with an ejection fraction (EF) of 50% or greater or less than 50', 'Patients With Heart Failure', '1761 participants included in the analysis (879 women and 882 men; mean [SD] age, 71.5 [9.6] years), 1394 (79.2%) reported β-blocker use and 1567 (89.0%) had an EF of 50% or greater', 'Participants had symptomatic HF with a left ventricular EF of 45% or greater, with enrollment based on either hospitalization attributed to decompensated HF in the prior year or elevated natriuretic peptide levels', 'patients with an EF of 50% or greater or less than 50', '1761 participants from North and South America enrolled in the multicenter, double-blinded Treatment of Preserved Cardiac Function Heart Failure with an', 'patients with heart failure (HF) with a preserved ejection fraction (HFpEF']","['Aldosterone Antagonist', 'Preserved Ejection Fraction', 'spironolactone']","['Cardiovascular Disease Mortality', 'HF hospitalizations and cardiovascular disease (CVD) mortality', 'Measures\n\n\nIncident HF hospitalization and CVD mortality', 'risk of HF hospitalizations', 'HF hospitalization and CVD mortality', 'higher risk of HF hospitalization', 'Hospitalizations for HF', 'CVD mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]",1761.0,0.150451,There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03).,"[{'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Silverman', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Infeld', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Callas', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Geoff B', 'Initials': 'GB', 'LastName': 'Dougherty', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16598'] 1576,32433572,Effect of antiseptic gels in the microbiologic colonization of the suture threads after oral surgery.,"Three different bioadhesive gels were evaluated in a double-blind randomized clinical trial in which microbial growth in the suture thread was assessed following post-surgical application of the aforementioned gels. Also assessed in this trial were, the intensity of post-surgical pain as well as the degree of healing of the patients' surgical wounds. A total of 21 patients (with 42 wisdom teeth) participated in this trial. Chlorhexidine gel, chlorhexidine-chitosan gel, and hyaluronic acid gel were evaluated, with a neutral water-based gel serving as the control agent. The aerobic and facultative anaerobic bacterial recovery on blood agar was lower in the placebo group than in the experimental groups. The most significant difference (p = 0.04) was observed in the chlorhexidine-chitosan group. in which the growth of Blood Agar and Mitis Salivarius Agar was significantly higher than in the placebo group. The intensity of post-surgical pain was very similar among all the groups. Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01). Through our microbiological analyses, we were able to conclude that none of the bioadhesive gels tested resulted in beneficial reductions in the bacterial/fungal populations. However, the healing rates of patients who were treated with chlorhexidine-chitosan were better than those of the patients who used either the placebo gel or the hyaluronic acid gel.",2020,"Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01).","['21 patients (with 42 wisdom teeth', 'microbiologic colonization of the suture threads after oral surgery']","['chlorhexidine-chitosan gel', 'placebo gel or the hyaluronic acid gel', 'hyaluronic acid gel', 'chlorhexidine', 'Chlorhexidine gel, chlorhexidine-chitosan gel, and hyaluronic acid gel', 'chlorhexidine-chitosan', 'antiseptic gels', 'placebo']","['blood agar', 'intensity of post-surgical pain', 'Blood Agar and Mitis Salivarius Agar', 'healing rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}]","[{'cui': 'C3266603', 'cui_str': 'Blood agar'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001771', 'cui_str': 'Agar'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",21.0,0.0631417,"Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Rodríguez Zorrilla', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain. samuel.rodriguez.zorrilla@outlook.com.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Blanco Carrión', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'García García', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry. Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo Moreno', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Xabier', 'Initials': 'X', 'LastName': 'Marichalar Mendía', 'Affiliation': 'Department of Stomatology II. School of Medicine and Dentistry, Leioa, Bizkaia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Seoane Prado', 'Affiliation': 'Microbiology Unit. School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Pérez Estévez', 'Affiliation': 'Microbiology Unit. School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Pérez-Sayáns', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry. Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain.'}]",Scientific reports,['10.1038/s41598-020-65007-y'] 1577,32103310,"A commentary on ""Impact of postoperative instructions on physical activity following pelvic reconstructive surgery: a randomized controlled trial"".",,2020,,['pelvic reconstructive surgery'],['postoperative instructions'],['physical activity'],"[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.220389,,"[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Rostaminia', 'Affiliation': 'NorthShore University HealthSystem, Skokie, IL, USA. ghazalerostaminia@yahoo.com.'}]",International urogynecology journal,['10.1007/s00192-020-04269-6'] 1578,31502906,A Comparative Effectiveness Trial of Two Patient-Centered Interventions for Women with Unmet Social Needs: Personalized Support for Progress and Enhanced Screening and Referral.,"Background: Despite recent widespread acceptance that unmet social needs are critically relevant to health, limited guidance exists about how best to address them in the context of women's health care delivery. We aimed to evaluate two interventions: enhanced screening and referral (ESR), a screening intervention with facilitated referral and follow-up calls, and personalized support for progress (PSP), a community health worker intervention tailored to women's priorities. Materials and Methods: Women >18 years were screened for presence of elevated depressive symptoms in three women's health clinics serving primarily Medicaid-eligible patients. If eligible and interested, we enrolled and randomized women to ESR or PSP. Pre- and postintervention assessments were conducted. Primary outcomes were satisfaction, depression, and quality of life (QOL). Planned analyses of subgroup differences were also explored. Results: A total of 235 participants were randomized; 54% identified as African American, 19% as White, and 15% as Latina. Participant mean age was 30 years; 77% reported annual incomes below US $20,000/year; and 30% were pregnant at enrollment. Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001). There were no differences between groups for the primary outcomes. Subgroups reporting greater improvement in QOL in PSP compared with ESR included participants who at baseline reported anxiety ( p  = 0.05), lack of access to depression treatment ( p  = 0.02), pain ( p  = 0.04), and intimate partner violence ( p  = 0.02). Conclusions: Clinics serving women with unmet social needs may benefit from offering PSP or ESR. Distinguishing how best to use these interventions in practice is the next step.",2020,Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001).,"['Women with Unmet Social Needs', ""Women >18 years were screened for presence of elevated depressive symptoms in three women's health clinics serving primarily Medicaid-eligible patients"", 'Participant mean age was 30 years; 77% reported annual incomes below US $20,000/year; and 30% were pregnant at enrollment', 'A total of 235 participants were randomized; 54% identified as African American, 19% as White, and 15% as Latina']","[""interventions: enhanced screening and referral (ESR), a screening intervention with facilitated referral and follow-up calls, and personalized support for progress (PSP), a community health worker intervention tailored to women's priorities"", 'ESR or PSP', 'Two Patient-Centered Interventions']","['lack of access to depression treatment', 'depression', 'pain', 'QOL in PSP', 'anxiety', 'satisfaction, depression, and quality of life (QOL', 'intimate partner violence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",235.0,0.12693,Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001).,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Poleshuck', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Hugh F', 'Initials': 'HF', 'LastName': 'Crean', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Juskiewicz', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Bell', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harrington', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cerulli', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7640'] 1579,31890657,"Anti-inflammatory effects of vitamin D and resistance training in men with type 2 diabetes mellitus and vitamin D deficiency: a randomized, double-blinded, placebo-controlled clinical trial.","Objectives The present study aimed to investigate the anti-inflammatory effects of vitamin D and resistance training in men with type 2 diabetes mellitus and vitamin D deficiency. Design This study was a randomized, placebo-controlled, double-blinded clinical trial. Trial registration code : IRCT20190204042621N1. Participants Forty-eight patients with type 2 diabetes aged 40-65 (from a total of 52 volunteers in Ardabil diabetes clinic) were randomly assigned to either the vitamin D supplementation with resistance training group (VD + RT: n  = 12), the resistance training group (RT: n  = 12), the vitamin D supplementation group (VD: n  = 12), or the control group (CON: n  = 12). Intervention The subjects in VD group took vitamin D supplements at 50000 IU per 2 weeks for 3 months; the subjects in RT group exercised 3 times per week for 12 weeks; and the subjects in VD + RT group participated in both treatments. Subjects in CON group were asked to maintain normal daily life pattern for the duration of the study. Measurements Serum Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α) and C-reactive protein (CRP) levels were determined at pre and post-test and the data were compared among the four groups and between two tests (4 × 2) using two-way ANOVA with repeated measures. Results IL-6 decreased significantly ( P  = 0.001) in all groups (VD + RT = % -71.73, RT = % -65.85, VD = % -61.70). TNF-α decreased significantly ( P  = 0.001) in VD + RT (% -44.90) and RT (% -40) groups. CRP showed no significant change in any group ( P  > 0.05). Conclusion Results demonstrated that vitamin D supplementation in addition to resistance training had positive effects on some inflammatory markers in T2D and vitamin D deficient men. Vitamin D supplementation was especially effective when it was complemented with exercise training.",2019,TNF-α decreased significantly ( P  = 0.001) in VD + RT (% -44.90) and RT (% -40) groups.,"['Participants\n\n\nForty-eight patients with type 2 diabetes aged 40-65 (from a total of 52 volunteers in Ardabil diabetes clinic', 'men with type 2 diabetes mellitus and vitamin D deficiency']","['vitamin D supplements', 'vitamin D and resistance training', 'Vitamin D supplementation', 'vitamin D supplementation', 'placebo', 'vitamin D supplementation with resistance training group (VD\u2009+\u2009RT: n \u2009=\u200912), the resistance training group (RT: n \u2009=\u200912), the vitamin D supplementation group (VD: n \u2009=\u200912), or the control group (CON: n \u2009=\u200912']","['CRP', 'TNF-α', 'IL-6', 'Measurements\n\n\nSerum Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α) and C-reactive protein ', 'CRP) levels']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",52.0,0.147183,TNF-α decreased significantly ( P  = 0.001) in VD + RT (% -44.90) and RT (% -40) groups.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dadrass', 'Affiliation': 'Department of Physical Education and Sport Sciences, Sanandaj Branch, Islamic Azad University, Pasdaran st, Sanandaj, 6616947443 Iran.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Mohamadzadeh Salamat', 'Affiliation': 'Department of Physical Education and Sport Sciences, Sanandaj Branch, Islamic Azad University, Pasdaran st, Sanandaj, 6616947443 Iran.'}, {'ForeName': 'Kamaladdin', 'Initials': 'K', 'LastName': 'Hamidi', 'Affiliation': 'Department of Biology, Mohaggheg Ardabili University, Ardabil, Iran.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Azizbeigi', 'Affiliation': 'Department of Physical Education and Sport Sciences, Sanandaj Branch, Islamic Azad University, Pasdaran st, Sanandaj, 6616947443 Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-019-00416-z'] 1580,31292608,Opening of ATP-sensitive potassium channels causes migraine attacks: a new target for the treatment of migraine.,"Migraine is one of the most disabling and prevalent of all disorders. To improve understanding of migraine mechanisms and to suggest a new therapeutic target, we investigated whether opening of ATP-sensitive potassium channels (KATP) would cause migraine attacks. In this randomized, double-blind, placebo-controlled, crossover study, 16 patients aged 18-49 years with one to five migraine attacks a month were randomly allocated to receive an infusion of 0.05 mg/min KATP channel opener levcromakalim and placebo on two different days (ClinicalTrials.gov number, NCT03228355). The primary endpoints were the difference in incidence of migraine attacks, headaches and the difference in area under the curve (AUC) for headache intensity scores (0-12 h) and for middle cerebral artery blood flow velocity (0-2 h) between levcromakalim and placebo. Between 24 May 2017 and 23 November 2017, 16 patients randomly received levcromakalim and placebo on two different days. Sixteen patients (100%) developed migraine attacks after levcromakalim compared with one patient (6%) after placebo (P = 0.0001); the difference of incidence is 94% [95% confidence interval (CI) 78-100%]. The incidence of headache over the 12 h observation period was higher but not significant after levcromakalim (n = 16) than after placebo (n = 7) (P = 0.016) (95% CI 16-71%). The AUC for headache intensity was significantly larger after levcromakalim compared to placebo (AUC0-12h, P < 0.0001). There was no change in mean middle cerebral artery blood flow velocity after levcromakalim compared to placebo (AUC0-2hP = 0.46). Opening of KATP channels caused migraine attacks in all patients. This suggests a crucial role of these channels in migraine pathophysiology and that KATP channel blockers could be potential targets for novel drugs for migraine.",2019,"The AUC for headache intensity was significantly larger after levcromakalim compared to placebo (AUC0-12h, P < 0.0001).","['16 patients aged 18-49 years with one to five migraine attacks a month', 'Between 24 May 2017 and 23 November 2017, 16 patients randomly received']","['KATP channel blockers', 'placebo', 'infusion of 0.05 mg/min KATP channel opener levcromakalim and placebo', 'levcromakalim and placebo']","['migraine attacks', 'mean middle cerebral artery blood flow velocity', 'incidence of headache', 'AUC for headache intensity', 'incidence of migraine attacks, headaches and the difference in area under the curve (AUC) for headache intensity scores (0-12 h) and for middle cerebral artery blood flow velocity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439420', 'cui_str': 'mg/min'}, {'cui': 'C0244960', 'cui_str': 'Levcromakalim'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.285709,"The AUC for headache intensity was significantly larger after levcromakalim compared to placebo (AUC0-12h, P < 0.0001).","[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jakob Møller', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Brain : a journal of neurology,['10.1093/brain/awz199'] 1581,31302249,Oral geranylgeranylacetone treatment increases heat shock protein expression in human atrial tissue.,"BACKGROUND Heat shock proteins (HSPs) are important chaperones that regulate the maintenance of healthy protein quality control in the cell. Impairment of HSPs is associated with aging-related neurodegenerative and cardiac diseases. Geranylgeranylacetone (GGA) is a compound well known to increase HSPs through activation of heat shock factor-1 (HSF1). GGA increases HSPs in various tissues, but whether GGA can increase HSP expression in human heart tissue is unknown. OBJECTIVE The purpose of this study was to test whether oral GGA treatment increases HSP expression in the atrial appendages of patients undergoing cardiac surgery. METHODS HSPB1, HSPA1, HSPD1, HSPA5, HSF1, and phosphorylated HSF1 levels were measured by western blot analysis in right and left atrial appendages (RAAs and LAAs, respectively) collected from patients undergoing coronary artery bypass grafting (CABG) who were treated with placebo (n = 13) or GGA 400 mg/da(n = 13) 3 days before surgery. Myofilament fractions were isolated from LAAs to determine the levels of HSPB1 and HSPA1 present in these fractions. RESULTS GGA treatment significantly increased HSPB1 and HSPA1 expression levels in RAA and LAA compared to the placebo group, whereas HSF1, phosphorylated HSF1, HSPD1, and HSPA5 were unchanged. In addition, GGA treatment significantly enhanced HSPB1 levels at the myofilaments compared to placebo. CONCLUSION Three days of GGA treatment is associated with higher HSPB1 and HSPA1 expression levels in RAA and LAA of patients undergoing CABG surgery and higher HSPB1 levels at the myofilaments. These findings pave the way to study the role of GGA as a protective compound against other cardiac diseases, including postoperative atrial fibrillation.",2020,Three days of GGA treatment is associated with higher HSPB1 and HSPA1 expression levels in RAA and LAA of patients undergoing CABG surgery and higher HSPB1 levels at the myofilaments.,"['patients undergoing coronary artery bypass grafting (CABG) who were treated with', 'patients undergoing cardiac surgery', 'human atrial tissue']","['oral GGA', 'placebo', 'Geranylgeranylacetone (GGA', 'GGA', 'Oral geranylgeranylacetone']","['HSF1, phosphorylated HSF1, HSPD1, and HSPA5', 'HSPA1, HSPD1, HSPA5, HSF1, and phosphorylated HSF1 levels', 'HSP expression', 'HSPB1 and HSPA1 expression levels', 'heat shock protein expression', 'HSPB1 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061231', 'cui_str': 'teprenone'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0018850', 'cui_str': 'Stress Proteins'}]",,0.0390482,Three days of GGA treatment is associated with higher HSPB1 and HSPA1 expression levels in RAA and LAA of patients undergoing CABG surgery and higher HSPB1 levels at the myofilaments.,"[{'ForeName': 'Denise M S', 'Initials': 'DMS', 'LastName': 'van Marion', 'Affiliation': 'Department of Physiology, Amsterdam UMC, Vrije Universiteit, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Dorsch', 'Affiliation': 'Department of Physiology, Amsterdam UMC, Vrije Universiteit, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Hoogstra-Berends', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Kakuchaya', 'Affiliation': 'A.N. Bakulev National Medical Research Center of Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Bockeria', 'Affiliation': 'A.N. Bakulev National Medical Research Center of Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'Natasja M S', 'Initials': 'NMS', 'LastName': 'de Groot', 'Affiliation': 'Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Bianca J J M', 'Initials': 'BJJM', 'LastName': 'Brundel', 'Affiliation': 'Department of Physiology, Amsterdam UMC, Vrije Universiteit, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. Electronic address: b.brundel@amsterdamumc.nl.'}]",Heart rhythm,['10.1016/j.hrthm.2019.07.010'] 1582,31808921,Effect of True and Sham Acupuncture on Radiation-Induced Xerostomia Among Patients With Head and Neck Cancer: A Randomized Clinical Trial.,"Importance Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Objective To determine if acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy. Design, Setting, and Participants This 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centers in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Intervention Either TA or SA using a validated acupuncture placebo device was performed 3 times per week during a 6- to 7-week course of radiation therapy. Main Outcomes and Measures The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes. Results Of 399 patients randomized, 339 were included in the final analysis (mean [SD] age, 51.3 [11.7] years; age range, 21-79 years; 258 [77.6%] men), including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45). Conclusions and Relevance This randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China. Trial Registration ClinicalTrials.gov identifier: NCT01266044.",2019,"TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45). ","['399 patients randomized, 339 were included in the final analysis (mean [SD] age, 51.3 [11.7] years; age range, 21-79 years; 258 [77.6%] men), including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group', 'patients with head and neck cancer undergoing radiation therapy', 'Patients were enrolled between December 16, 2011, and July 7, 2015', 'patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centers in the United States and China', 'Patients With Head and Neck Cancer', 'patients with head and neck cancer']","['TA or SA', 'TA', 'True and Sham Acupuncture', 'acupuncture placebo device', 'Importance\n\n\nRadiation-induced xerostomia (RIX', 'standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA', 'acupuncture']","['RIX, as determined by the Xerostomia Questionnaire', 'SA', 'adjusted least square mean (SD) xerostomia score', 'incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes', 'severe RIX symptoms', 'xerostomia', 'Quality of life', 'Radiation-Induced Xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1275047', 'cui_str': 'Radiation-induced xerostomia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0729650', 'cui_str': 'Constituents (substance)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1275047', 'cui_str': 'Radiation-induced xerostomia'}]",339.0,0.161611,"TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45). ","[{'ForeName': 'M Kay', 'Initials': 'MK', 'LastName': 'Garcia', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chambers', 'Affiliation': 'Department of Dental Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Chaosu', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Caijun', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Bei', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Prinsloo', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Department of Anesthesiology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lopez', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16910'] 1583,32066599,Multicentre randomised controlled trial to evaluate the efficacy of pre-emptive inferior mesenteric artery embolisation during endovascular aortic aneurysm repair on aneurysm sac change: protocol of Clarify IMA study.,"INTRODUCTION Type II endoleak (EL) is frequently seen after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) and is often considered responsible for aneurysm sac enlargement if it persists. In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres. At present, there is a lack of robust evidence to support the efficacy of pre-emptive embolisation of IMA on reduction of persistent type II EL with subsequent sac shrinkage. METHOD AND ANALYSIS This multicentre, randomised controlled trial will recruit 200 patients who have fusiform AAA ≥50 mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a pre-emptive IMA embolisation group or non-embolisation control group in a ratio of 1:1. The primary endpoint is the difference of aneurysm sac volume change assessed by CT scans between the pre-emptive IMA embolisation group and the control group at 12 months after EVAR. The secondary endpoints are defined as change of aneurysm sac volume in both groups at 6 and 24 months, freedom from sac enlargement at 12 and 24 months after EVAR, prevalence of type II EL at 1, 6, 12 and 24 months evaluated by contrast-enhanced CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation. ETHICS AND DISSEMINATION The protocol has been reviewed and approved by the ethics committee of Nara Medical University (No. 2113). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications, scientific conferences and the University Hospital Medical Information Network Clinical Trials Registry home page. TRIAL REGISTRATION NUMBER UMIN000035502.",2020,"In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres.","['200 patients who have fusiform AAA ≥50\u2009mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a', 'Nara Medical University']","['pre-emptive inferior mesenteric artery embolisation', 'endovascular aneurysm repair (EVAR', 'endovascular aortic aneurysm repair', 'pre-emptive IMA embolisation group or non-embolisation control']","['freedom from sac enlargement', 'change of aneurysm sac volume', 'difference of aneurysm sac volume change assessed by CT scans', 'CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332493', 'cui_str': 'Fusiform shape (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0162860', 'cui_str': 'Mesenteric Artery, Inferior'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0397942', 'cui_str': 'Aortic aneurysm repair (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]",200.0,0.126967,"In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres.","[{'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Ichihashi', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan shigeoichivasc@gmail.com.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': 'Department of Diabetes Care Medicine and Department of Metabolic Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Fujimura', 'Affiliation': 'Vascular Surgery, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Nagatomi', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwakoshi', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bolstad', 'Affiliation': 'Clinical English, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Kichikawa', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-031758'] 1584,32103495,Omega-3 PUFA and aspirin as adjuncts to periodontal debridement in patients with periodontitis and type 2 diabetes mellitus: Randomized clinical trial.,"BACKGROUND Supplementation with omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA) have been proposed as a host modulation regimen to control chronic inflammatory diseases. The aim of this study was to investigate the clinical and immunological impact of orally administered ω-3 PUFA and ASA as adjuncts to periodontal debridement for the treatment of periodontitis in patients type 2 diabetes. METHODS Seventy-five patients (n = 25/group) were randomly assigned to receive placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) after periodontal debridement (test group [TG]1), or ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) before periodontal debridement (TG2). Periodontal parameters and GCF were collected at baseline (t0), 3 months after periodontal debridement and ω-3 PUFA + ASA or placebo for TG1 and CG (t1), after ω-3 PUFA + ASA (before periodontal debridement) for TG2 (t1), and 6 months after periodontal debridement (all groups) (t2). GCF was analyzed for cytokine levels by multiplex ELISA. RESULTS Ten patients (40%) in TG1 and nine patients (36%) in TG2 achieved the clinical endpoint for treatment (less than or equal to four sites with probing depth ≥ 5 mm), as opposed to four (16%) in CG. There was clinical attachment gain in moderate and deep pockets for TG1. IFN-γ and interleukin (IL)-8 levels decreased over time for both test groups. IL-6 levels were lower for TG1. HbA1c levels reduced for TG1. CONCLUSION Adjunctive ω-3 and ASA after periodontal debridement provides clinical and immunological benefits to the treatment of periodontitis in patients with type 2 diabetes.",2020,IFN-γ and IL-8 levels decreased over time for both test groups.,"['patients with periodontitis and type 2 diabetes mellitus', 'patients with type 2 diabetes', 'Seventy-five patients (n = 25/group', 'patients type 2 diabetes']","['Omega-3 PUFA and aspirin', 'ω-3 PUFA + ASA or placebo', 'ω-3 PUFA and ASA', 'placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) after periodontal debridement (Test Group [TG]1), or ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) before periodontal debridement (TG2', 'omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA']","['clinical attachment gain', 'HbA1c levels', 'IFN-γ and IL-8 levels', 'IL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936227', 'cui_str': 'Nonsurgical Periodontal Debridement'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.114601,IFN-γ and IL-8 levels decreased over time for both test groups.,"[{'ForeName': 'Nidia C', 'Initials': 'NC', 'LastName': 'Castro Dos Santos', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Naira M R B', 'Initials': 'NMRB', 'LastName': 'Andere', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Cássia F', 'Initials': 'CF', 'LastName': 'Araujo', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'de Marco', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Alpdogan', 'Initials': 'A', 'LastName': 'Kantarci', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Van Dyke', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Mauro P', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0613'] 1585,32494981,Comparison of S-1-cisplatin every 5 weeks with capecitabine-cisplatin every 3 weeks for HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced): pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.,"BACKGROUND We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC). We performed a pooled analysis of HERBIS-4A and HERBIS-2, the phase II trial comparing SP with XP in HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of ≥ 6 months. PATIENTS AND METHODS Patients were randomly assigned to receive either SP [S-1 (40-60 mg twice daily for 21 days) plus cisplatin (60 mg/m 2  on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m 2  twice daily for 14 days) plus cisplatin (80 mg/m 2 on day 1), every 3 weeks]. RESULTS In the pooled analysis, SP (n = 44-50) showed a longer progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P = 0.062], overall survival (14.8 versus 10.6 months; HR, 0.695; P = 0.099), and time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P = 0.045) as well as a higher disease control rate (86.4% versus 68.1%, P = 0.149) compared with XP (n = 47-51). A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach. CONCLUSION Our pooled analysis supports the use of SP in the first-line setting for patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of ≥ 6 months. CLINICAL TRIAL REGISTRATION The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105.",2020,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach. ","['HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of\u2009≥\u20096\xa0months', 'Patients', 'chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC', 'HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced', 'patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of\u2009≥\u20096\xa0months']","['S-1 plus cisplatin (SP) with\xa0capecitabine plus cisplatin (XP', 'XP', 'S-1-cisplatin', 'capecitabine-cisplatin', 'SP [S-1', 'cisplatin', 'XP [capecitabine']","['time to treatment failure', 'longer progression-free survival', 'overall survival', 'disease control rate']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.153097,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach. ","[{'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, 377-2 Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan. kawakami_h@med.kindai.ac.jp.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka Prefectural General Medical Center, Osaka-shi, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, Ikeda, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Kindai University, Osaka-sayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Makari', 'Affiliation': 'Department of Medical Oncology, Kindai University Nara Hospital, Ikoma, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Cancer Center, Izumi City General Hospital, Izumi, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-020-01711-z'] 1586,31626327,When a randomized controlled trial is unlikely: Propensity score analysis of blinatumomab in adults with relapsed/refractory Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia.,,2020,,['adults with relapsed/refractory Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia'],['blinatumomab'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C1292769', 'cui_str': 'c-ALL'}]","[{'cui': 'C3853839', 'cui_str': 'blinatumomab'}]",[],,0.253247,,"[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Cassaday', 'Affiliation': 'Division of Hematology, Department of Medicine, University of Washington School of Medicine, Seattle, Washington.'}]",Cancer,['10.1002/cncr.32565'] 1587,31799694,Are Lactobacillus salivarius G60 and inulin more efficacious to treat patients with oral halitosis and tongue coating than the probiotic alone and placebo? A randomized clinical trial.,"BACKGROUND The combination of probiotics and prebiotics might be useful to treat oral halitosis. The aim of this study was to assess the effect of Lactobacillus salivarius G60 (LS) and inulin on oral halitosis and tongue coating. METHODS In this double-masked, randomized, phase II clinical trial, 45 patients (aged 35 ± 15 years, 66% female) with oral halitosis and tongue coating were allocated to three treatment groups (n = 15) using gums of oral dissolution (one gum every 12 hours) for 10 days. Each gum contained LS (1 billion colony forming units [CFUs]) + inulin (1 g), LS (1 billion CFU) or placebo. Primary outcomes were organoleptic test, Halimeter, and tongue coating, whereas secondary outcomes were quality of life (QOL) and treatment safety. Generalized linear models were used, adjusting for age and sex. In vitro tests were performed to verify whether LS interacts with inulin and whether LS inhibits the growth of Porphyromonas gingivalis and Prevotella intermedia. RESULTS Forty-four patients (97%) completed the study. Patients treated with LS + inulin showed greater reduction in halitosis measured by Halimeter compared with placebo (adjusted post-intervention average: 96.7 versus 142.5 ppb; P = 0.003), whereas LS and placebo did not differ (115.7 versus 142.5 ppb; P = 0.097). Organoleptic measurements and coating index showed a similar decrease for all groups. QOL improved in patients treated with LS + inulin compared with placebo (P = 0.029). Side effects were mild and transient in all groups. LS did not metabolize inulin but inhibited the growth of P. gingivalis and P. intermedia after 72 hours. CONCLUSIONS Treatment with L. salivarius G60 combined or not with inulin showed significant decrease in the outcomes organoleptic test, Halimeter, and coating index, improving oral halitosis. However, no significant difference was obtained between the groups.",2020,Quality of life improved in patients treated with LS+inulin compared to placebo (p = 0.029).,"['Forty-four patients (97%) completed the study', '45 patients (35 ± 15 years old, 66% female) with oral halitosis and tongue coating']","['placebo', 'Lactobacillus salivarius G60 (LS) and inulin', 'gums of oral dissolution', 'LS+inulin']","['organoleptic test, Halimeter and tongue coating', 'quality of life and treatment safety', 'Organoleptic measurements and coating index', 'reduction in halitosis', 'Quality of life', 'outcomes organoleptic test, Halimeter and coating index, improving oral halitosis', 'Side effects']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317593', 'cui_str': 'Lactobacillus salivarius'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.197802,Quality of life improved in patients treated with LS+inulin compared to placebo (p = 0.029).,"[{'ForeName': 'Camila Rafaela', 'Initials': 'CR', 'LastName': 'Mousquer', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Della Bona', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Daiane Cristina', 'Initials': 'DC', 'LastName': 'Milani', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Sidia Maria', 'Initials': 'SM', 'LastName': 'Callegari-Jacques', 'Affiliation': 'Department of Statistics, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Microbiology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcia Pinto Alves', 'Initials': 'MPA', 'LastName': 'Mayer', 'Affiliation': 'Department of Microbiology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cassiano Kuchenbecker', 'Initials': 'CK', 'LastName': 'Rösing', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fornari', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0089'] 1588,14599044,Prebiotic concept for infant nutrition.,"In the neonatal period, the intestine is colonised in a stepwise process that depends on mode of delivery, environmental factors, bacterial interactions, and the host itself resulting in a colonisation with a complex heterogeneous bacterial flora. Oligosaccharides have been identified as an important prebiotic factor of human milk As long as analogues of human milk oligosaccharides are not available now and in the near future it is aimed to resemble the prebiotic effect of human milk by oligosaccharides from available sources. In the present study in preterm infants, a mixture of 90% galacto-oligosaccharides and 10% fructo-oligosaccharides has been tested. The mixture of GOS/FOS was composed to mimic the molecule size distribution of human milk oligosaccharides. Microbiological analysis of the faces was performed before and 7, 14, and 28 days after start of supplementation and stool characteristics have been recorded. Maltodextrin was used as placebo and infants fed human milk have been used as reference. After a 28 days feeding period, the number of bifidobacteria of the group fed the oligosaccharide supplemented formula was in the upper range of the reference group whereas the numbers of the group fed the formula supplemented with the placebo were in the lower range of the reference group (placebo: 7.9 +/- 0.83 and GOS/FOS mixture: 10,0 +/- 2.05 log 10 CFU/g wet stool; reference (M +/- SD): 7.14-10.7 log 10 CFU/g wet stool). Stool characteristics in the group fed the supplemented formula were close to those found in the human milk fed infants. In summary, supplementation of a preterm formula with a mixture of galacto- and fructo-oligosaccharides has a stimulating effect on the growth of bifidobacteria in the intestine and results in more frequent produced and softer stools. Thus, prebiotic mixtures such like the studied oligosaccharide mixture might help in improving intestinal tolerance to enteral feeding in preterm infants.",2003,"After a 28 days feeding period, the number of bifidobacteria of the group fed the oligosaccharide supplemented formula was in the upper range of the reference group whereas the numbers of the group fed the formula supplemented with the placebo were in the lower range of the reference group (placebo: 7.9 +/-","['human milk', 'preterm infants']","['Maltodextrin', 'reference group (placebo: 7.9 ', 'placebo']","['intestinal tolerance', 'Stool characteristics', 'number of bifidobacteria']","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0430283,"After a 28 days feeding period, the number of bifidobacteria of the group fed the oligosaccharide supplemented formula was in the upper range of the reference group whereas the numbers of the group fed the formula supplemented with the placebo were in the lower range of the reference group (placebo: 7.9 +/-","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Boehm', 'Affiliation': 'Numico Research, Friedrichsdorf, Germany. Gunther.Boehm@Milupa.de'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fanaro', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jelinek', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Stahl', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marini', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992). Supplement",[] 1589,31493942,Findings from the recovery initiation and management after overdose (RIMO) pilot study experiment.,"This pilot study evaluated the feasibility of the Recovery Initiation and Management after Overdose (RIMO) intervention to link individuals to medication-assisted treatment (MAT) following an opioid overdose. The study team worked with the Chicago Fire Department to train Emergency Medical Service (EMS) teams to request permission from individuals after an opioid overdose reversal to release their contact information; individuals were subsequently contacted by the study team for participation. A mixed-methods study design comprised: (1) an experimental pilot study that examined participation at each stage of the intervention and compared the odds of treatment received for individuals who were randomly assigned to either the RIMO intervention (n = 16) or a passive referral control (n = 17); and (2) a focus group that was subsequently conducted with participants in the RIMO group to obtain their feedback on the intervention components. Quantitative data was collected on participant characteristics at study intake and treatment received was based on self-report at a 30-day follow-up. The RIMO group had higher odds of receiving any treatment for opioid use (OR = 7.94) and any MAT (OR = 20.2), and received significantly more days of opioid treatment (Ms=15.2 vs. 3.4) and more days of MAT in the 30 days post-randomization (Ms=11.2 vs. 0.76), relative to the control group (all p < .05). Qualitative data illustrated that participants valued the assertive outreach, engagement, and persistent follow-up components of RIMO, which differed from their prior experiences. The pilot study suggests that the RIMO intervention is able to address the challenges of linking and engaging individuals into MAT after an opioid overdose.",2020,"The RIMO group had higher odds of receiving any treatment for opioid use (OR = 7.94) and any MAT (OR = 20.2), and received significantly more days of opioid treatment (Ms=15.2 vs. 3.4) and more days of MAT in the 30 days post-randomization (Ms=11.2 vs. 0.76), relative to the control group (all p < .05).",['study team worked with the Chicago Fire Department to train Emergency Medical Service (EMS) teams to request permission from individuals after an opioid overdose reversal to release their contact information; individuals were subsequently contacted by the study team for participation'],"['RIMO intervention', 'Recovery Initiation and Management after Overdose (RIMO) intervention', 'RIMO intervention (n\u202f=\u202f16) or a passive referral control']",[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0239607,"The RIMO group had higher odds of receiving any treatment for opioid use (OR = 7.94) and any MAT (OR = 20.2), and received significantly more days of opioid treatment (Ms=15.2 vs. 3.4) and more days of MAT in the 30 days post-randomization (Ms=11.2 vs. 0.76), relative to the control group (all p < .05).","[{'ForeName': 'Christy K', 'Initials': 'CK', 'LastName': 'Scott', 'Affiliation': 'Lighthouse Institute, Chestnut Health Systems, Chicago, IL 221 W. Walton, Chicago, IL 60610, United States of America. Electronic address: cscott@chestnut.org.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Dennis', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Drive, Normal, IL 61761, United States of America. Electronic address: mdennis@chestnut.org.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Grella', 'Affiliation': 'Chestnut Health Systems, Chicago, IL 221 W. Walton, Chicago, IL 60610, United States of America. Electronic address: cegrella@chestnut.org.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nicholson', 'Affiliation': 'Chestnut Health Systems, Chicago, IL 221 W. Walton, Chicago, IL 60610, United States of America. Electronic address: lnicholson@chestnut.org.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Sumpter', 'Affiliation': 'Chestnut Health Systems, Chicago, IL 221 W. Walton, Chicago, IL 60610, United States of America. Electronic address: jesumpter@chestnut.org.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kurz', 'Affiliation': 'Chestnut Health Systems, Chicago, IL 221 W. Walton, Chicago, IL 60610, United States of America. Electronic address: rkurz@chestnut.org.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Funk', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Drive, Normal, IL 61761, United States of America. Electronic address: rfunk@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.004'] 1590,31812686,Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial.,"INTRODUCTION Clinical research and management of postmenopausal vaginal symptoms have been limited by the lack of validated measures for assessing symptom impact. AIM To evaluate convergent-divergent validity of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire among postmenopausal women with moderate-to-severe vulvovaginal symptoms and identify demographic and clinical factors associated with greater symptom impact. METHODS We examined baseline data from postmenopausal women with moderate-to-severe vulvovaginal itching, pain, irritation, dryness, or pain with intercourse in a randomized trial of vaginal estradiol, moisturizer, or placebo. In addition to completing the DIVA questionnaire, participants rated the severity of their most bothersome vulvovaginal symptom, underwent assessment of vaginal pH and epithelial cytology, and completed other self-report measures including the Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), and Patient Health Questionnaire-8 for depression (PHQ-8). MAIN OUTCOME MEASURE The main outcome measures were the unadjusted correlations and multivariable-adjusted associations with 4 DIVA domain scales designed to assess symptom impact on day-to-day activities, sexual functioning, emotional well-being, and body image/self-concept on a scale of 0 to 4. RESULTS Among 301 women, we detected moderately strong correlations between the DIVA emotional well-being scale and PHQ-8 scores (Pearson correlation coefficient [r] = 0.39) and strong correlations between the DIVA sexual functioning scale and FSFI and FSDS scores (r > 0.50). No significant correlations were detected between any DIVA scales and vaginal pH or epithelial cytology. In adjusted linear-regression analyses, greater vulvovaginal symptom severity was associated with worse DIVA scores for emotional well-being, sexual functioning, and self-concept/body image (average 0.3- to 0.5-point higher DIVA score for each 1-point difference in vulvovaginal symptom severity). Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score). Women reporting recent sexual activity had lower symptom impact on sexual functioning and self-concept/body image domains (-0.3- to -0.4-point lower DIVA score with weekly sexual activity). CLINICAL IMPLICATIONS Findings suggest that the impact of postmenopausal vaginal symptoms on functioning and well-being is greater in women with co-morbid depression symptoms and less frequent sexual activity, independent of symptom severity. STRENGTHS & LIMITATIONS Strengths include the multicenter sample and wide array of measures. Results may not generalize to women with mild symptoms. CONCLUSION Our results support the construct validity of the DIVA questionnaire for clinical practice and research and indicate that depression and lower frequency of sexual activity are markers of greater impact of postmenopausal vaginal symptoms on multiple dimensions of functioning and quality of life. Hunter MM, Guthrie KA, Larson JC, et al. Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial. J Sex Med 2020;17:117-125.",2020,Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score).,"['postmenopausal women with moderate-to-severe vulvovaginal symptoms', 'women with mild symptoms', '301 women', 'postmenopausal women with moderate-to-severe vulvovaginal itching, pain, irritation, dryness, or pain with intercourse']","['Vaginal Aging (DIVA) questionnaire', 'vaginal estradiol, moisturizer, or placebo']","['DIVA scores for emotional well-being, sexual functioning, and self-concept/body image', 'DIVA sexual functioning scale and FSFI and FSDS scores', 'worse DIVA scores for activities of daily living and emotional well-being', 'severity of their most bothersome vulvovaginal symptom', 'DIVA scales and vaginal pH or epithelial cytology', 'vulvovaginal symptom severity', 'Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), and Patient Health Questionnaire-8 for depression (PHQ-8', 'symptom impact on day-to-day activities, sexual functioning, emotional well-being, and body image/self-concept on a scale of 0 to\xa04', 'DIVA emotional well-being scale and PHQ-8 scores', 'Depression symptoms']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",301.0,0.0763158,Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score).,"[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Hunter', 'Affiliation': 'School of Nursing, University of California San Francisco, San Francisco, CA. Electronic address: mary.hunter@ucsf.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Larson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Obstetrics and Gynecology, University of Washington, Seattle, WA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': 'Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.010'] 1591,31871115,Anti-PD-L1 (atezolizumab) as an immune primer and concurrently with extended-field chemoradiotherapy for node-positive locally advanced cervical cancer.,"BACKGROUND There is a lack of data exploring the use and optimal timing of immunotherapy and chemoradiation therapy (CRT) in node-positive cervical cancer. Further translational research into mechanisms of response and resistance to immunotherapy in advanced cervical cancer is warranted. PRIMARY OBJECTIVES To determine if sequencing of atezolizumab and CRT result in differential immune activation, as determined by clonal expansion of T cell receptor beta (TCRB) repertoires in peripheral blood on day 21. STUDY HYPOTHESIS There is a difference for clonal expansion of T cell receptor beta repertoires in the peripheral blood at day 21 between the priming and concurrent atezolizumab and CRT in Arm A vs the concurrent atezolizumab and CRT in Arm B. TRIAL DESIGN Locally advanced cervical cancer patients with lymph node-positive disease will be randomized on this open-label, randomized trial with two experimental arms. Arm A will get one dose of atezolizumab prior to cisplatin CRT, and then two subsequent doses of atezolizumab during the CRT, and Arm B will get three doses during CRT. Patients will be followed for 2 years to assess outcomes. MAJOR INCLUSION/EXCLUSION CRITERIA Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes. Exclusion criteria include those who had a prior hysterectomy or lymph node dissection. PRIMARY ENDPOINTS Clonal expansion of TCRB) repertoires in peripheral blood on day 21. SAMPLE SIZE The sample size will be 40 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS We estimate accrual to finish by the summer of 2020 with presentation of results to follow in 2021. TRIAL REGISTRATION NCT03738228.",2020,"There is a difference for clonal expansion of T cell receptor beta repertoires in the peripheral blood at day 21 between the priming and concurrent atezolizumab and CRT in Arm A vs the concurrent atezolizumab and CRT in Arm B. ","['Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes', '40 patients', 'node-positive locally advanced cervical cancer', 'Exclusion criteria include those who had a prior hysterectomy or lymph node dissection', 'advanced cervical cancer', 'node-positive cervical cancer', 'Locally advanced cervical cancer patients with lymph node-positive disease']","['Anti-PD-L1 (atezolizumab', 'immunotherapy and chemoradiation therapy (CRT', 'atezolizumab and CRT', 'atezolizumab', 'atezolizumab prior to cisplatin CRT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous cell carcinoma'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0740255', 'cui_str': 'Para-aortic lymph node group (body structure)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0229789', 'cui_str': 'Para-aortic node (body structure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",[],,0.173007,"There is a difference for clonal expansion of T cell receptor beta repertoires in the peripheral blood at day 21 between the priming and concurrent atezolizumab and CRT in Arm A vs the concurrent atezolizumab and CRT in Arm B. ","[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mayadev', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego Medical Center, La Jolla, California, USA jmayadev@ucsd.edu.'}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Zamarin', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Biostatistics and Bioinformatics, NRG Oncology, Clinical Trial Development Division, Buffalo, New York, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lankes', 'Affiliation': ""Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001012'] 1592,31859246,"CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis.","BACKGROUND Cyclin-dependent kinase 4/6 inhibitors (CDKIs) are indicated with endocrine therapy as first-line or second-line treatment for hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer. We aimed to investigate the benefit of adding CDKIs to endocrine therapy in patients whose tumours might have differing degrees of endocrine sensitivity. METHODS We pooled individual patient data from all phase 3 randomised breast cancer trials of CDKIs plus endocrine therapy submitted to the US Food and Drug Administration before Jan 1, 2019, in support of marketing applications. Our pooled analysis included all randomly assigned patients in these trials who received at least one dose of CDKI or placebo with endocrine therapy (an aromatase inhibitor [letrozole or anastrazole] or fulvestrant). We did prespecified subgroup analyses in patients with progesterone receptor-negative disease; patients with a disease-free interval of 12 months or less; patients with de-novo metastases, lobular histology, and bone-only disease; patients with visceral metastases; and patients aged up to 40 years. Patients who were not treated, who received tamoxifen as endocrine therapy, or who were treated with an aromatase inhibitor but who had received previous chemotherapy in the metastatic setting (not first-line) were excluded from our pooled analyses. All studies had a primary endpoint of investigator-assessed progression-free survival, defined as time from date of randomisation to the initial date of documented cancer progression or death, whichever occurred first. Median progression-free survival was estimated with Kaplan-Meier methods. Hazard ratios (HR) with 95% CIs for progression-free survival were estimated by means of Cox regression models. FINDINGS The seven studies meeting this study's inclusion criteria were done between Feb 22, 2013, and Nov 3, 2017, with a median duration of follow-up of 19·7 months (IQR 15·9-25·9). 4200 patients were included in the pooled analysis, of whom 1320 received an aromatase inhibitor plus a CDKI, 932 received placebo plus an aromatase inhibitor, 1296 received fulvestrant plus a CDKI, and 652 received fulvestrant plus placebo. Across all seven pooled trials, the difference in estimated median progression-free survival was 8·8 months in favour of CDKI plus endocrine therapy over placebo plus endocrine therapy (range across the trials 6·8-13·3 months; HR 0·59, 95% CI 0·54-0·64). Progression-free survival results favoured the CDKI group in all prespecified clinicopathological subgroups analysed, with similar HRs to that for the broader intended-use population. In first-line aromatase inhibitor-treated patients (n=2252), the median progression-free survival in the CDKI plus aromatase inhibitor group was 28·0 months (95% CI 25·3-29·1) versus 14·9 months (14·0-16·7) in the placebo plus aromatase inhibitor group (difference 13·1 months; range across the trials 13·0-13·3 months; HR 0·55, 95% CI 0·49-0·62). In first-line fulvestrant-treated patients (n=396), the median progression-free survival was 18·6 months (95% CI 14·8-23·5) in the placebo plus fulvestrant group and not estimable (22·4 to not estimable) in the CDKI plus fulvestrant group (difference not estimable; HR 0·58, 95% CI 0·42-0·80). In the patients treated with fulvestrant in the second-line setting and beyond (n=1552), the difference in estimated median progression-free survival between the CDKI plus fulvestrant group and the placebo plus fulvestrant group was 6·9 months in favour of the CDKI group (range across the trials 5·5-7·3 months; HR 0·56, 95% CI 0·49-0·64). INTERPRETATION Since the addition of CDKI to endocrine therapy seemed to benefit all clinicopathological subgroups of interest in this pooled analysis, further research is needed to identify patient subgroups for whom endocrine therapy alone might be appropriate for first-line or second-line treatment of hormone receptor-positive, HER2-negative metastatic breast cancer. FUNDING None.",2020,"Progression-free survival results favoured the CDKI group in all prespecified clinicopathological subgroups analysed, with similar HRs to that for the broader intended-use population.","['patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer', 'patients whose tumours might have differing degrees of endocrine sensitivity', 'Patients who were not treated, who received tamoxifen as endocrine therapy, or who were treated with an aromatase inhibitor but who had received previous chemotherapy in the metastatic setting (not first-line', '4200 patients were included in the pooled analysis, of whom 1320 received an', 'patients with progesterone receptor-negative disease; patients with a disease-free interval of 12 months or less; patients with de-novo metastases, lobular histology, and bone-only disease; patients with visceral metastases; and patients aged up to 40 years']","['placebo plus fulvestrant', 'CDK4/6 inhibitor treatment', 'CDKI or placebo with endocrine therapy (an aromatase inhibitor [letrozole or anastrazole] or fulvestrant', 'aromatase inhibitor plus a CDKI, 932 received placebo plus an aromatase inhibitor, 1296 received fulvestrant plus a CDKI, and 652 received fulvestrant plus placebo', 'fulvestrant', 'placebo plus aromatase inhibitor', 'placebo plus endocrine therapy', 'CDKIs plus endocrine therapy']","['Median progression-free survival', 'median progression-free survival', 'Progression-free survival', 'investigator-assessed progression-free survival', 'progression-free survival', 'cancer progression or death', 'estimated median progression-free survival', 'Hazard ratios (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205417', 'cui_str': 'Lobular (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",4200.0,0.348473,"Progression-free survival results favoured the CDKI group in all prespecified clinicopathological subgroups analysed, with similar HRs to that for the broader intended-use population.","[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: jennifer.gao@fda.hhs.gov.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Office of Translational Sciences, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Office of Translational Sciences, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'Palantir Technologies, Palo Alto, CA, USA.'}, {'ForeName': 'Suparna B', 'Initials': 'SB', 'LastName': 'Wedam', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Office of Translational Sciences, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA; Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Tatiana M', 'Initials': 'TM', 'LastName': 'Prowell', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30804-6'] 1593,31451521,"Effect of Intermittent Versus Continuous Low-Dose Aspirin on Nasal Epithelium Gene Expression in Current Smokers: A Randomized, Double-Blinded Trial.","A chemopreventive effect of aspirin (ASA) on lung cancer risk is supported by epidemiologic and preclinical studies. We conducted a randomized, double-blinded study in current heavy smokers to compare modulating effects of intermittent versus continuous low-dose ASA on nasal epithelium gene expression and arachidonic acid (ARA) metabolism. Fifty-four participants were randomized to intermittent (ASA 81 mg daily for one week/placebo for one week) or continuous (ASA 81 mg daily) for 12 weeks. Low-dose ASA suppressed urinary prostaglandin E2 metabolite (PGEM; change of -4.55 ± 11.52 from baseline 15.44 ± 13.79 ng/mg creatinine for arms combined, P = 0.02), a surrogate of COX-mediated ARA metabolism, but had minimal effects on nasal gene expression of nasal or bronchial gene-expression signatures associated with smoking, lung cancer, and chronic obstructive pulmonary disease. Suppression of urinary PGEM correlated with favorable changes in a smoking-associated gene signature ( P < 0.01). Gene set enrichment analysis (GSEA) showed that ASA intervention led to 1,079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database. In conclusion, low-dose ASA had minimal effects on known carcinogenesis gene signatures in nasal epithelium of current smokers but results in wide-ranging genomic changes in the nasal epithelium, demonstrating utility of nasal brushings as a surrogate to measure gene-expression responses to chemoprevention. PGEM may serve as a marker for smoking-associated gene-expression changes and systemic inflammation. Future studies should focus on NSAIDs or agent combinations with broader inhibition of pro-inflammatory ARA metabolism to shift gene signatures in an anti-carcinogenic direction.",2019,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"['Fifty-four participants were randomized to intermittent ', 'current heavy smokers', 'current smokers']","['intermittent versus continuous low dose ASA', 'aspirin (ASA', 'placebo', 'intermittent versus continuous low dose aspirin', 'ASA intervention', 'ASA']","['nasal epithelium gene expression', 'lung cancer risk', 'Suppression of urinary PGEM', 'urinary prostaglandin E2 metabolite (PGEM', 'nasal epithelium gene expression and arachidonic acid (ARA) metabolism']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C3241966'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0599331', 'cui_str': 'Nasal Epithelium'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",54.0,0.22044,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"[{'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Garland', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona. lgarland@azcc.arizona.edu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guillen-Rodriguez', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Chiu-Hsieh', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Merenstein', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Lel', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Hanqiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Avrum E', 'Initials': 'AE', 'LastName': 'Spira', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Beane', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wojtowicz', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'H-H Sherry', 'Initials': 'HS', 'LastName': 'Chow', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0036'] 1594,31486832,Assessment of Treatment With Sorafenib Plus Doxorubicin vs Sorafenib Alone in Patients With Advanced Hepatocellular Carcinoma: Phase 3 CALGB 80802 Randomized Clinical Trial.,"Importance Previous communication has reported significant improvement in overall survival (OS) when using doxorubicin plus sorafenib in the treatment of advanced hepatocellular cancer (HCC). Objective To determine if doxorubicin added to sorafenib therapy improves OS, with stratification for locally advanced and metastatic disease. Design, Setting, and Participants This unblinded randomized phase 3 clinical trial was led by Alliance in collaboration with Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Canadian Cancer Trials Group, and Southwest Oncology Group. It was launched in February 2010 and completed in May 2015; data were also analyzed during this time frame. Patients with histologically proven advanced HCC, no prior systemic therapy, Child-Pugh grade A score, Eastern Cooperative Oncology Group performance status of 0 to 2 (later amended to 0-1), and adequate hematologic, hepatic, renal, and cardiac function were eligible. The OS primary end point had a final analysis planned with 364 events observed among 480 total patients with 90% power to detect a 37% increase in median OS. Interventions or Exposures Patients received either 60 mg/m2 of doxorubicin every 21 days plus 400 mg of sorafenib orally twice daily or the sorafenib alone, adjusted to half doses for patients with bilirubin levels of 1.3 to 3.0 mg/dL. Main Outcomes and Measures The primary end point was OS, and progression-free survival (PFS) was a secondary end point. Results Of 356 patients included in the study, the mean (SD) age was 62 (10.1) years, and 306 (86.0%) were men. Although it was planned to include 480 patients, the study was halted after accrual of 356 patients (180 patients treated with doxorubicin plus sorafenib and 176 with sorafenib alone) with a futility boundary crossed at a planned interim analysis. Median OS was 9.3 months (95% CI, 7.3-10.8 months) in the doxorubicin plus sorafenib arm and 9.4 months (95% CI, 7.3-12.9 months) in the sorafenib alone arm (hazard ratio, 1.05; 95% CI, 0.83-1.31). The median PFS was 4.0 months (95% CI, 3.4-4.9 months) in the doxorubicin plus sorafenib arm and 3.7 months (95% CI, 2.9-4.5 months) in the sorafenib alone arm (hazard ratio, 0.93; 95% CI, 0.75-1.16). Grade 3 or 4 neutropenia and thrombocytopenia adverse events occurred in 61 (36.8%) and 29 (17.5%) patients, respectively, being treated with doxorubicin plus sorafenib vs 1 (0.6%) and 4 (2.4%) patients treated with sorafenib. Conclusions and Relevance This multigroup study of the addition of doxorubicin to sorafenib therapy did not show improvement of OS or PFS in patients with HCC. Trial Registration ClinicalTrials.gov identifier: NCT01015833.",2019,"Grade 3 or 4 neutropenia and thrombocytopenia adverse events occurred in 61 (36.8%) and 29 (17.5%) patients, respectively, being treated with doxorubicin plus sorafenib vs 1 (0.6%) and 4 (2.4%) patients treated with sorafenib. ","['collaboration with Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Canadian Cancer Trials Group, and Southwest Oncology Group', 'mean (SD) age was 62 (10.1) years, and 306 (86.0%) were men', 'and 176 with sorafenib alone) with a futility boundary crossed at a planned interim analysis', '356 patients included in the study', 'Patients with histologically proven advanced HCC, no prior systemic therapy, Child', '480 patients, the study was halted after accrual of 356 patients (180 patients treated with', 'advanced hepatocellular cancer (HCC', 'patients with HCC', 'Patients With Advanced Hepatocellular Carcinoma']","['60 mg/m2 of doxorubicin', 'sorafenib orally twice daily or the sorafenib alone', 'Sorafenib Plus Doxorubicin vs Sorafenib Alone', 'doxorubicin plus sorafenib', 'doxorubicin', 'sorafenib therapy', 'doxorubicin to sorafenib therapy']","['Grade 3 or 4 neutropenia and thrombocytopenia adverse events', 'OS, and progression-free survival (PFS', 'median PFS', 'median OS', 'OS or PFS', 'overall survival (OS', 'Median OS', 'adequate hematologic, hepatic, renal, and cardiac function']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",480.0,0.121298,"Grade 3 or 4 neutropenia and thrombocytopenia adverse events occurred in 61 (36.8%) and 29 (17.5%) patients, respectively, being treated with doxorubicin plus sorafenib vs 1 (0.6%) and 4 (2.4%) patients treated with sorafenib. ","[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Knox', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kaubisch', 'Affiliation': 'Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Posey', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Tan', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kavan', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Goel', 'Affiliation': 'Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Lammers', 'Affiliation': 'Meharry Medical College, Nashville, Tennessee.'}, {'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Tam', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Rajdev', 'Affiliation': 'Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}, {'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'El Dika', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ryan I', 'Initials': 'RI', 'LastName': 'Potaracke', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Balletti', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Harding', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Suga', 'Affiliation': 'Kaiser Permanente Vallejo Medical Center, Vallejo, California.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2792'] 1595,31478763,A Randomized Trial of a 1-Hour Troponin T Protocol in Suspected Acute Coronary Syndromes: The Rapid Assessment of Possible Acute Coronary Syndrome in the Emergency Department With High-Sensitivity Troponin T Study (RAPID-TnT).,"BACKGROUND High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. RESULTS In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P <0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P <0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P <0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0-99.9%) for 30-day death or myocardial infarction. CONCLUSIONS This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505.",2019,The 0/1-hour hs-TnT protocol was not inferior to standard care,"['Patients', 'Median age was 59 (49-70) years, and 47% were female', 'Suspected Acute Coronary Syndromes', 'patients with newly recognized troponin T elevation', 'suspected ACS patients presenting to the emergency department (ED', '3378 participants with an emergency presentation were randomized between August 2015 and April 2019', 'Ninety participants were deemed ineligible or withdrew consent', 'suspected ACS patients']","['0/1-hour high-sensitivity troponin T (hs-cTnT) protocol compared with a 0/3-hour masked hs-cTnT protocol', '0/1-hour hs-cTnT', '1-Hour Troponin T Protocol', 'care guided either by the 0 /1-hour hs-cTnT protocol (n=1646) or the 3-hour standard masked hs-cTnT protocol', 'Possible ACS']","['median ED length of stay', 'cause death and MI. Non-inferiority', 'myocardial injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",90.0,0.236706,The 0/1-hour hs-TnT protocol was not inferior to standard care,"[{'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Chew', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lambrakis', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blyth', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Seshadri', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Michael J R', 'Initials': 'MJR', 'LastName': 'Edmonds', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Briffa', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth (T.B.).'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Cullen', 'Affiliation': ""Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Australia (L.A.C.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Department of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia (S.Q.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Karnon', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Chuang', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Nelson', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide (D.P.C., A.J.C.).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Horsfall', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'French', 'Affiliation': 'Department of Cardiology, University of New South Wales, Sydney, Australia (J.K.F.).'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Papendick', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042891'] 1596,31474116,Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus.,"BACKGROUND Patients with type 2 diabetes mellitus (T2DM) are at increased risk of developing heart failure. Sodium-glucose cotransporter-2 inhibitors reduce the risk of hospitalization for heart failure (HHF) in patients with T2DM. We aimed to develop and validate a practical clinical risk score for HHF in patients with T2DM and assess whether this score can identify high-risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor. METHODS We developed a clinical risk score for HHF in 8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53). Candidate variables were assessed using multivariable Cox regression, and independent clinical risk indicators achieving statistical significance of P <0.001 were included in the risk score. We externally validated the score in 8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58). The relative and absolute risk reductions in HHF with the sodium-glucose cotransporter-2 inhibitor dapagliflozin were assessed by baseline HHF risk. RESULTS Five clinical variables were independent risk predictors of HHF: prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio. A simple integer-based score (0-7 points) using these predictors identified a >20-fold gradient of HHF risk ( P for trend <0.001) in both the derivation and validation cohorts, with C indices of 0.81 and 0.78, respectively. Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively. CONCLUSIONS Risk stratification using a novel clinical risk score for HHF in patients with T2DM identifies patients at higher risk for HHF who derive greater absolute benefit from sodium-glucose cotransporter-2 inhibition. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01107886 and NCT01730534.",2019,"Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively. ","['Patients', 'patients with T2DM', '8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58', 'risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor', 'Patients With Type 2 Diabetes Mellitus', 'Patients with type 2 diabetes mellitus (T2DM', '8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53']","['dapagliflozin', 'Sodium-Glucose Cotransporter-2 Inhibitors', 'Saxagliptin', 'Sodium-glucose cotransporter-2 inhibitors']","['HHF: prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio', 'risk of hospitalization for heart failure (HHF', 'absolute risk reductions', 'HHF risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C3811844'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.0836097,"Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively. ","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Canada (L.A.L.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'University of Liverpool, United Kingdom (J.P.H.W.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042685'] 1597,30380365,Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer.,"BACKGROUND There are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer. METHODS In this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than -7.2 percentage points (i.e., closer to zero). RESULTS A total of 319 patients were assigned to minimally invasive surgery and 312 to open surgery. Of the patients who were assigned to and underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% robot-assisted surgery. Overall, the mean age of the patients was 46.0 years. Most patients (91.9%) had stage IB1 disease. The two groups were similar with respect to histologic subtypes, the rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy. The rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of -10.6 percentage points (95% confidence interval [CI], -16.4 to -4.7). Minimally invasive surgery was associated with a lower rate of disease-free survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30). CONCLUSIONS In this trial, minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. (Funded by the University of Texas M.D. Anderson Cancer Center and Medtronic; LACC ClinicalTrials.gov number, NCT00614211 .).",2018,"Minimally invasive surgery was associated with a lower rate of disease-free survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30). ","['patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma', 'Cervical Cancer', '319 patients', 'women with early-stage cervical cancer']","['minimally invasive surgery and 312 to open surgery', 'abdominal radical hysterectomy', 'laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery', 'minimally invasive radical hysterectomy', 'minimally invasive surgery or open surgery', 'minimally invasive surgery', 'abdominal radical hysterectomy (open surgery', 'laparoscopy and 15.6% robot-assisted surgery', 'Minimally Invasive versus Abdominal Radical Hysterectomy']","['hazard ratio for disease recurrence or death', 'rate of disease-free survival', 'rates of disease-free survival and overall survival', 'stage IB1 disease', 'rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1 (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous cell carcinoma'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C3179006', 'cui_str': 'Tumor Grading'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]",319.0,0.376832,"Minimally invasive surgery was associated with a lower rate of disease-free survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30). ","[{'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frumovitz', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Vieira', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Reitan', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Shuzhong', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Naven', 'Initials': 'N', 'LastName': 'Chetty', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Tamura', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Behan', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Nicklin', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': ""From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).""}]",The New England journal of medicine,['10.1056/NEJMoa1806395'] 1598,32439849,Effects of caffeine intake and exercise intensity on executive and arousal vigilance.,"During physical efforts and sport practice, vigilance is responsible for maintaining an optimal state of activation, guaranteeing the ability to quickly respond and detect unexpected, but critical, stimuli over time. Caffeine and physical exercise are able to modulate the activation state, affecting vigilance performance. The aim of the present work was to assess the specific effects and modulations of caffeine intake and two physical intensities on vigilance components. Participants performed an attentional task (ANTI-Vea) to measure the executive and arousal components of vigilance, in six double-blinded counterbalanced sessions combining caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise. Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates. Instead, caffeine intake generally improved arousal vigilance. In conclusion, caffeine and acute exercise seems to moderate executive and arousal vigilance in different ways.",2020,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.",[],"['Caffeine and physical exercise', 'caffeine', 'attentional task (ANTI-Vea', 'caffeine and acute exercise', 'caffeine intake and exercise intensity', 'caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise']","['arousal vigilance', 'moderate executive and arousal vigilance', 'executive and arousal vigilance', 'executive vigilance with faster overall reaction time (RT), without impairing error rates']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0355207,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanchis', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain. carlos.sanchis@ucv.es.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Blasco', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain. jlupiane@ugr.es.'}]",Scientific reports,['10.1038/s41598-020-65197-5'] 1599,31623622,Advantages of using 3D virtual reality based training in persons with Parkinson's disease: a parallel study.,"BACKGROUND Parkinson's disease (PD) is a slowly progressive neurodegenerative disease. There are mixed reports on success of physiotherapy in patients with PD. Our objective was to investigate the functional improvements, motivation aspects and clinical effectiveness when using immersive 3D virtual reality versus non-immersive 2D exergaming. METHODS We designed a randomized parallel study with 97 patients, but only 20 eligible participants were randomized in 2 groups; the one using 3D Oculus Rift CV1 and the other using a laptop. Both groups participated in the 10-session 3 weeks training with a pick and place task in the virtual world requiring precise hand movement to manipulate the virtual cubes. The kinematics of the hand was traced with Leap motion controller, motivation effect was assessed with modified Intrinsic Motivation Inventory and clinical effectiveness was evaluated with Box & Blocks Test (BBT) and shortened Unified Parkinson's disease rating scale (UPDRS) before and after the training. Mack-Skilling non-parametrical statistical test was used to identify statistically significant differences (p < 0.05) and Cohen's U3 test to find the effect sizes. RESULTS Participants in the 3D group demonstrated statistically significant and substantially better performance in average time of manipulation (group x time, p = 0.009), number of successfully placed cubes (group x time, p = 0.028), average tremor (group x time, p = 0.002) and UPDRS for upper limb (U3 = 0.35). The LCD and 3D groups substantially improved their BBT score with training (U3 = 0.7, U3 = 0.6, respectively). However, there were no statistically significant differences in clinical tests between the groups (group x time, p = 0.2189, p = 0.2850, respectively). In addition the LCD group significantly decreased the pressure/tension (U3 = 0.3), the 3D did not show changes (U3 = 0.5) and the differences between the groups were statistically different (p = 0.037). The 3D group demonstrated important increase in effort (U3 = 0.75) and perceived competences (U3 = 0.9). CONCLUSIONS The outcomes of the study demonstrated that the immersive 3D technology may bring increased interests/enjoyment score resulting in faster and more efficient functional performance. But the 2D technology demonstrated lower pressure/tension score providing similar clinical progress. A study with much larger sample size may also confirm the clinical effectiveness of the approaches. TRIAL REGISTRATION The small scale randomized pilot study has been registered at ClinicalTrials.gov Identifier: NCT03515746 , 4 May 2018.",2019,"The 3D group demonstrated important increase in effort (U3 = 0.75) and perceived competences (U3 = 0.9). ","[""persons with Parkinson's disease"", 'patients with PD', '97 patients, but only 20 eligible participants']","['immersive 3D virtual reality versus non-immersive 2D exergaming', '3D virtual reality based training', 'LCD']","['average tremor', 'interests/enjoyment score', 'number of successfully placed cubes', 'modified Intrinsic Motivation Inventory and clinical effectiveness', 'pressure/tension score', 'average time of manipulation', 'BBT score', 'clinical tests', 'functional improvements, motivation aspects and clinical effectiveness', ""Box & Blocks Test (BBT) and shortened Unified Parkinson's disease rating scale (UPDRS"", 'pressure/tension']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation, function (observable entity)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}]",,0.0553687,"The 3D group demonstrated important increase in effort (U3 = 0.75) and perceived competences (U3 = 0.9). ","[{'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Cikajlo', 'Affiliation': 'University Rehabilitation Institute, Republic of Slovenia, Linhartova 51, SI-1000, Ljubljana, Slovenia. imre.cikajlo@ir-rs.si.'}, {'ForeName': 'Karmen', 'Initials': 'K', 'LastName': 'Peterlin Potisk', 'Affiliation': 'University Rehabilitation Institute, Republic of Slovenia, Linhartova 51, SI-1000, Ljubljana, Slovenia.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0601-1'] 1600,31442936,Externalizing trajectories predict elevated inflammation among adolescents exposed to early institutional rearing: A randomized clinical trial.,"BACKGROUND There has been mounting interest in the pathophysiological relation between inflammation and psychopathology. In this paper, we examined associations between internalizing and externalizing psychopathology and inflammation in adolescents with a history of severe psychosocial deprivation and children reared in typical family contexts. METHOD The Bucharest Early Intervention Project is a longitudinal randomized trial of high-quality foster care as an alternative to institutional care. This report is based on 56 institutionalized children randomized to care as usual, 59 institutionalized children randomized to foster care, and 101 never institutionalized children who were recruited as an in-country comparison sample. Externalizing and internalizing behaviors were reported by parents and teachers at ages 8, 12, and 16. At age 16, C-reactive protein (CRP) was derived from blood spots in a subset of participants (n = 127). Multiple-group latent growth curve models were used to examine externalizing and internalizing trajectories and their associations with CRP. RESULTS Among children assigned to care as usual, higher levels of externalizing behaviors at age 8, as well as smaller decreases in these behaviors from 8 to 16 years predicted higher levels of CRP at age 16. In the same group of children, higher internalizing behaviors at age 8, but not the rate of change in these behaviors, also predicted higher levels of CRP. In contrast, these relations were not observed in the children assigned to foster care and never institutionalized controls. CONCLUSIONS Early institutional rearing is associated with a coupling of psychopathology and inflammation, whereas early placement into foster care buffers against these risks. These findings have implications for promoting healthy mental and physical development amongst institutionalized children.",2019,"Among children assigned to care as usual, higher levels of externalizing behaviors at age 8, as well as smaller decreases in these behaviors from 8 to 16 years predicted higher levels of CRP at age 16.","['56 institutionalized children randomized to care as usual, 59 institutionalized children randomized to foster care, and 101 never institutionalized children who were recruited as an in-country comparison sample', 'institutionalized children', 'adolescents exposed to early institutional rearing', 'adolescents with a history of severe psychosocial deprivation and children reared in typical family contexts']",[],"['externalizing behaviors', 'internalizing behaviors', 'levels of CRP', 'Externalizing and internalizing behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033962', 'cui_str': 'Psychosocial Deprivation'}, {'cui': 'C0008091', 'cui_str': 'Child Rearing'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.05392,"Among children assigned to care as usual, higher levels of externalizing behaviors at age 8, as well as smaller decreases in these behaviors from 8 to 16 years predicted higher levels of CRP at age 16.","[{'ForeName': 'Alva', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, United States. Electronic address: alvatang@umd.edu.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, MA, United States; Harvard Graduate School of Education, Cambridge, MA, United States.""}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Slopen', 'Affiliation': 'Shool of Public Health, University of Maryland, College Park, MD, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104408'] 1601,29995456,MEF2 as upstream regulator of the transcriptome signature in human skeletal muscle during unloading.,"Our understanding of skeletal muscle structural and functional alterations during unloading has increased in recent decades, yet the molecular mechanisms underpinning these changes have only started to be unraveled. The purpose of the current investigation was to assess changes in skeletal muscle gene expression after 21 days of bed rest, with a particular focus on predicting upstream regulators of muscle disuse. Additionally, the association between differential microRNA expression and the transcriptome signature of bed rest were investigated. mRNAs from musculus vastus lateralis biopsies obtained from 12 men before and after the bed rest were analyzed using a microarray. There were 54 significantly upregulated probesets after bed rest, whereas 103 probesets were downregulated (false discovery rate 10%; fold-change cutoff ≥1.5). Among the upregulated genes, transcripts related to denervation-induced alterations in skeletal muscle were identified, e.g., acetylcholine receptor subunit delta and perinatal myosin. The most downregulated transcripts were functionally enriched for mitochondrial genes and genes involved in mitochondrial biogenesis, followed by a large number of contractile fiber components. Upstream regulator analysis identified a robust inhibition of the myocyte enhancer factor-2 (MEF2) family, in particular MEF2C, which was suggested to act upstream of several key downregulated genes, most notably peroxisome proliferator-activated receptor γ coactivator 1-α (PGC-1α)/peroxisome proliferator-activated receptors (PPARs) and CRSP3. Only a few microRNAs were identified as playing a role in the overall transcriptome picture induced by sustained bed rest. Our results suggest that the MEF2 family is a key regulator underlying the transcriptional signature of bed rest and, hence, ultimately also skeletal muscle alterations induced by systemic unloading in humans.",2018,"Upstream regulator analysis identified a robust inhibition of the myocyte enhancer factor-2 (MEF2) family, in particular MEF2C, which was suggested to act upstream of several key downregulated genes, most notably peroxisome proliferator-activated receptor γ coactivator 1-α (PGC-1α)/peroxisome proliferator-activated receptors (PPARs) and CRSP3.",[],[],[],[],[],[],,0.0500948,"Upstream regulator analysis identified a robust inhibition of the myocyte enhancer factor-2 (MEF2) family, in particular MEF2C, which was suggested to act upstream of several key downregulated genes, most notably peroxisome proliferator-activated receptor γ coactivator 1-α (PGC-1α)/peroxisome proliferator-activated receptors (PPARs) and CRSP3.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullman', 'Affiliation': 'Department of Laboratory Medicine, Clinical Physiology, Karolinska Institutet and Karolinska University Hospital , Stockholm , Sweden.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernandez-Gonzalo', 'Affiliation': 'Department of Laboratory Medicine, Clinical Physiology, Karolinska Institutet and Karolinska University Hospital , Stockholm , Sweden.'}, {'ForeName': 'Igor B', 'Initials': 'IB', 'LastName': 'Mekjavić', 'Affiliation': 'Department of Automation, Biocybernetics and Robotics, Jozef Stefan Institute , Ljubljana , Slovenia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Laboratory Medicine, Clinical Physiology, Karolinska Institutet and Karolinska University Hospital , Stockholm , Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Eiken', 'Affiliation': 'Department of Environmental Physiology, Swedish Aerospace Physiology Centre, KTH Royal Institute of Technology , Stockholm , Sweden.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00452.2017'] 1602,31740726,"Neuromodulation of the prefrontal cortex facilitates diet-induced weight loss in midlife women: a randomized, proof-of-concept clinical trial.","BACKGROUND High body mass index (BMI) is associated with neurocognitive impairments that contribute to overeating and interfere with weight loss efforts. Overweight and obesity at midlife can accelerate neurodegenerative changes and increase the risk of late-life dementia. Noninvasive neuromodulation represents a novel, affordable and scalable approach to improve neurocognitive function in this context. The purpose of this proof-of-concept study was to examine whether transcranial direct current stimulation (tDCS) aimed at enhancing prefrontal cortex activity could enhance weight loss, in combination with a hypocaloric diet, and study underlying mechanisms. METHODS Overall, 38 women with BMI 25-35 kg/m 2 underwent a 4 week randomized, double-blinded, sham-controlled, and parallel-design intervention, during which they received eight sessions of tDCS (n = 18 sham, n = 20 active) in combination with a diet (caloric goal of 20 kcal/kg/day). We evaluated longitudinal changes in body weight, appetite and food craving. In addition, we examined the contribution of cognitive-executive processes via food-modified computerized tasks. RESULTS We found that the active group had more reduction in body weight than the sham group throughout the study (p = 0.020) and significant weekly weight loss. At 4 weeks, the active group lost 2.32% of initial body weight (sham: 1.29%). Components of subjective appetite and food craving showed a trend toward more reduction in the active group. These changes were paralleled by significant improvements in task performance in the active group, particularly in a dual task that required inhibitory control and working memory (p = 0.007-0.031). Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003). No significant adverse effects were observed. CONCLUSIONS Our results provide proof-of-concept validation of prefrontal-targeted tDCS, combined with a diet, in midlife women with excess body weight, paving the way for larger studies evaluating clinical efficacy and long-term effects of this intervention.",2020,"Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003).","['38 women with BMI 25-35\u2009kg/m 2', 'midlife women with excess body weight', 'midlife women']","['transcranial direct current stimulation (tDCS', 'tDCS (n\u2009=\u200918 sham, n\u2009=\u200920 active) in combination with a diet']","['neurocognitive function', 'body weight', 'body weight, appetite and food craving', 'weight loss', 'task performance', 'inhibitory control and working memory', 'subjective appetite and food craving', 'adverse effects', 'lack of control overeating']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]",38.0,0.115754,"Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Amo Usanos', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Villa', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Santiago Milla', 'Initials': 'SM', 'LastName': 'Navarro', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Andresa Evelem de', 'Initials': 'AE', 'LastName': 'Melo Aroeira', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Amo Usanos', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Martínez Cancio', 'Affiliation': 'Primary Care Unit, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cuesta Villa', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Section on Genetics and Epidemiology, Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. migalonsoalonso@alumni.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0486-x'] 1603,31935026,Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,"Importance Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. Objective To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. Design, Setting, and Participants The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017. Interventions Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). Main Outcomes and Measures The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. Results Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]). Conclusions and Relevance Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. Trial Registration ClinicalTrials.gov Identifier: NCT01238172.",2020,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","['Men', '64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis', 'men with early-stage prostate cancer', 'men with early-stage prostate cancer managed with active surveillance', ""Participants\n\n\nThe Men's Eating and Living (MEAL) Study (CALGB 70807"", 'With Early-Stage Prostate Cancer', '478 patients randomized (mean [SD] age', '91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group\u2009=\u20091 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level', 'prostate cancer survivors']","['Guidelines endorsing vegetable-enriched diets', 'counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n\u2009=\u2009237) or a control group, which received written information about diet and prostate cancer (n\u2009=\u2009241', 'behavioral intervention that increased vegetable intake', 'Behavioral Intervention to Increase Vegetable Consumption']","['time to progression; progression', 'Cancer Progression', 'PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade', 'cancer progression', '24-month Kaplan-Meier progression-free percentages', 'time to progression', 'risk of prostate cancer progression', 'prostate cancer progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",478.0,0.259409,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","[{'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Hansel', 'Affiliation': 'Department of Pathology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Stroup', 'Affiliation': 'Department of Urology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Veldhuizen', 'Affiliation': 'Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.'}, {'ForeName': 'Lannis', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",JAMA,['10.1001/jama.2019.20207'] 1604,31469938,Complex and subtle structural changes in prefrontal cortex induced by inhibitory control training from childhood to adolescence.,"A number of training interventions have been designed to improve executive functions and inhibitory control (IC) across the lifespan. Surprisingly, no study has investigated the structural neuroplasticity induced by IC training from childhood to late adolescence, a developmental period characterized by IC efficiency improvement and protracted maturation of prefrontal cortex (PFC) subregions involved in IC. The aim of the present study was to investigate the behavioral and structural changes induced by a 5-week computerized and adaptive IC training in school-aged children (10-year-olds) and in adolescents (16-year-olds). Sixty-four children and 59 adolescents were randomly assigned to an IC (i.e. Color-Word Stroop and Stop-Signal tasks) or an active control (AC) (knowledge- and vocabulary-based tasks) training group. In the pre- and posttraining sessions, participants performed the Color-Word Stroop and Stop-signal tasks, and an anatomical resonance imaging (MRI) was acquired for each of them. Children's IC efficiency improved from the pre- to the posttraining session in boys but not in girls. In adolescents, IC efficiency did not improve after IC training. Similar to the neuroplastic mechanisms observed during brain maturation, we observed IC training-related changes in cortical thickness and cortical surface area in several PFC subregions (e.g. the pars opercularis, triangularis, and orbitalis of the inferior frontal gyri) that were age- and gender-specific. Because no correction for multiple comparisons was applied, the results of our study provide only preliminary evidence of the complex structural neuroplastic mechanisms at the root of behavioral changes in IC efficiency from pre- to posttraining in school-aged children and adolescents.",2020,Children's IC efficiency improved from the pre- to the posttraining session in boys but not in girls.,"['childhood to adolescence', 'school-aged children (10-year-olds) and in adolescents (16-year-olds', 'school-aged children and adolescents', 'Sixty-four children and 59 adolescents']","['IC (i.e., Color-Word Stroop and Stop-Signal tasks) or an active control (knowledge- and vocabulary-based tasks) training group', '5-week computerized and adaptive IC training', 'inhibitory control training']","[""Children's IC efficiency""]","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",64.0,0.0290699,Children's IC efficiency improved from the pre- to the posttraining session in boys but not in girls.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Delalande', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Moyon', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Cloélia', 'Initials': 'C', 'LastName': 'Tissier', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Dorriere', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guillois', 'Affiliation': 'Hôpital Clemenceau, CHU de Caen, Caen, France.'}, {'ForeName': 'Katel', 'Initials': 'K', 'LastName': 'Mevell', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Charron', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Salvia', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Poirel', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lion', 'Affiliation': 'Biomarkers of Brain Development and Disorders, Institute of Psychiatry and Neuroscience of Paris, INSERM UMR894, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Oppenheim', 'Affiliation': 'Biomarkers of Brain Development and Disorders, Institute of Psychiatry and Neuroscience of Paris, INSERM UMR894, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Houdé', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Borst', 'Affiliation': 'Université de Paris, LaPsyDÉ, CNRS, Paris, France.'}]",Developmental science,['10.1111/desc.12898'] 1605,32439957,A randomized trial of intravenous acetaminophen versus indomethacin for treatment of hemodynamically significant PDAs in VLBW infants.,"Objective was to compare the rate of successful treatment of hsPDA based on echocardiogram criteria after use of IV acetaminophen or IV indomethacin in very low-birthweight infants. The study was a multi-center, randomized controlled trial. Infants born prior to 32 weeks with birthweight ≤ 1500 g were included if PDA treatment was indicated within the 21 days after birth. hsPDA was defined by strict echocardiogram criteria. Eligible infants were randomized to treatment with either IV acetaminophen or IV indomethacin. Of 86 eligible infants, 17 infants were randomized to acetaminophen and 20 to indomethacin. One (5.9%) hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002). Eight (47%) in the acetaminophen group and 3 (15%) in the indomethacin group received transcatheter PDA closure (p = 0.07). IV indomethacin was more effective than IV acetaminophen for treatment of hsPDAs. More infants in the acetaminophen group received transcatheter closure.",2020,hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002).,"['Eligible infants', 'very low-birthweight infants', 'Infants born prior to 32 weeks with birthweight ≤\u20091500\u2009g were included if', '86 eligible infants, 17 infants', 'VLBW infants']","['indomethacin', 'IV acetaminophen or IV indomethacin', 'IV indomethacin', 'PDA', 'transcatheter closure', 'acetaminophen', 'acetaminophen or IV indomethacin']","['transcatheter PDA closure', 'hsPDA']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",17.0,0.0650303,hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002).,"[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Davidson', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA. jhendr20@uthsc.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ivey', 'Affiliation': 'Mednax/Germantown Hospital, Germantown, TN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Philip', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Weems', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Talati', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0694-1'] 1606,30930211,Effect of Low-pressure Pulmonary Recruitment Maneuver on Postlaparoscopic Shoulder Pain: Randomized Controlled Trial.,"STUDY OBJECTIVE Postlaparoscopic shoulder pain (PLSP) is effectively reduced by a pulmonary recruitment maneuver (PRM). The goal of this study is to assess the efficacy of a PRM using maximal inspiratory pressure of 30 cm H 2 O, which is lower than previously studied pressure for reducing PLSP. DESIGN Randomized controlled trial. SETTING University hospital. PATIENTS Eighty-four patients who were undergoing elective gynecologic laparoscopy. INTERVENTIONS Patients were randomly assigned to the control (n = 42) or the PRM (n = 42) group. MEASUREMENTS AND MAIN RESULTS The primary outcome was the intensity of the shoulder pain using the visual analog scale (VAS). The VAS score of shoulder pain (median [interquartile range]) was significantly lower in the PRM group than in the control group at 24 hours (0 [0-0] vs 1.5 [0-4.0], p <.001) and 48 hours (0 [0-0] vs 1.0 [0-2.0], p <.001) after surgery. Other variables, including surgical pain score and vital signs, were similar between the 2 groups. CONCLUSION The PRM with 30 cm H 2 O can be a simple method to reduce PLSP. Therefore, it would be helpful to perform the PRM with 30 cm H 2 O routinely.",2020,The VAS score of shoulder pain (median [interquartile range]) was significantly lower in the PRM group than in the control group at 24 hours (0,"['Eighty-four patients who were undergoing elective gynecologic laparoscopy', 'University hospital', 'Postlaparoscopic shoulder pain (PLSP']","['PRM', 'Low-pressure Pulmonary Recruitment Maneuver']","['intensity of the shoulder pain using the visual analog scale (VAS', 'Postlaparoscopic Shoulder Pain', 'surgical pain score and vital signs', 'VAS score of shoulder pain']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0518766'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",84.0,0.137009,The VAS score of shoulder pain (median [interquartile range]) was significantly lower in the PRM group than in the control group at 24 hours (0,"[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Chunghyun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Jihee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Ki', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Cha', 'Affiliation': 'Obstetrics and Gynecology (Dr. Cha), CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine (Dr. J. Y. Kim), Ajou University School of Medicine, Suwon, Korea.. Electronic address: kjyeop@ajou.ac.kr.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.03.020'] 1607,31148204,Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial.,"Thromboelastography (TEG) provides a more comprehensive global coagulation assessment than routine tests (international normalized ratio [INR] and platelet [PLT] count), and its use may avoid unnecessary blood component transfusion in patients with advanced cirrhosis and significant coagulopathy who have nonvariceal upper gastrointestinal (GI) bleeding. A total of 96 patients with significant coagulopathy (defined in this study as INR >1.8 and/or PLT count < 50 × 10 9 /L) and nonvariceal upper GI bleed (diagnosed after doing upper gastrointestinal endoscopy, which showed ongoing bleed from a nonvariceal source) were randomly allocated to TEG-guided transfusion strategy (TEG group; n = 49) or standard-of-care (SOC) group (n = 47). In the TEG group, only 26.5% patients were transfused with all three blood components (fresh frozen plasma [FFP], PLTs, and cryoprecipitate) versus 87.2% in the SOC group (P < 0.001). Although 7 (14.3%) patients in the TEG group received no blood component transfusion, there were no such patients in the SOC group (P = 0.012). Also, there was a significantly lower use of blood components (FFP, PLTs, and cryoprecipitate) in the TEG group compared with the SOC group. Failure to control bleed, failure to prevent rebleeds, and mortality between the two groups were similar. Conclusion: In patients with advanced cirrhosis with coagulopathy and nonvariceal upper GI bleeding, TEG-guided transfusion strategy leads to a significantly lower use of blood components compared with SOC (transfusion guided by INR and PLT count), without an increase in failure to control bleed, failure to prevent rebleed, and mortality.",2020,"Also, there was a significantly lower use of blood components (FFP, PLTs, and cryoprecipitate) in the TEG group compared to the SOC group.","['Patients With Cirrhosis With Nonvariceal Bleeding', '96 patients with significant coagulopathy (defined in this study as INR >1.8 and/or PLT count <50 × 10 9 /L) and nonvariceal upper GI bleed (diagnosed after doing upper gastrointestinal endoscopy [UGIE], which showed ongoing bleed from a nonvariceal source', 'patients with advanced cirrhosis and significant coagulopathy who have nonvariceal upper gastrointestinal (GI) bleeding', 'patients with advanced cirrhosis with coagulopathy and nonvariceal upper GI bleeding, TEG-guided transfusion strategy']","['TEG-guided transfusion strategy (TEG group; n = 49) or standard-of-care (SOC', 'Thromboelastography (TEG', 'TEG', 'Thromboelastography-Guided Blood Component Use']","['failure to control bleed, failure to prevent rebleed, and mortality', 'blood component transfusion', 'Failure to control bleed, failure to prevent rebleeds, and mortality', 'blood components (FFP, PLTs, and cryoprecipitate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1263666', 'cui_str': 'Advanced cirrhosis'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0450129', 'cui_str': 'Blood component (substance)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085430', 'cui_str': 'Blood Component Transfusion'}, {'cui': 'C0450129', 'cui_str': 'Blood component (substance)'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}]",96.0,0.0330223,"Also, there was a significantly lower use of blood components (FFP, PLTs, and cryoprecipitate) in the TEG group compared to the SOC group.","[{'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Ahmad', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Maiwall', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Bajpai', 'Affiliation': 'Department of Transfusion Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Lalita G', 'Initials': 'LG', 'LastName': 'Mitra', 'Affiliation': 'Department of Critical Care Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Saluja', 'Affiliation': 'Department of Critical Care Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Mohan Agarwal', 'Affiliation': 'Department of Critical Care Medicine, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Chhagan', 'Initials': 'C', 'LastName': 'Bihari', 'Affiliation': 'Department of Pathology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Saggere Muralikrishna', 'Initials': 'SM', 'LastName': 'Shasthry', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Clinical Research, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Biostatistics, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv K', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30794'] 1608,31211448,Randomized phase I clinical trial of anti-α-synuclein antibody BIIB054.,"BACKGROUND Pathological and genetic evidence implicates toxic effects of aggregated α-synuclein in the pathophysiology of neuronal dysfunction and degeneration in Parkinson's disease. Immunotherapy targeting aggregated α-synuclein is a promising strategy for delaying disease progression. OBJECTIVE This study (NCT02459886) evaluated the safety, tolerability, and pharmacokinetics of BIIB054, a human-derived monoclonal antibody that preferentially binds to aggregated α-synuclein, in healthy volunteers and participants with Parkinson's disease. METHODS A total of 48 healthy volunteers (age 40-65, 19 women) and 18 Parkinson's disease participants (age 47-75, 5 women, Hoehn and Yahr stage ≤2.5) were in the study. Volunteers were enrolled into 6 single-dose cohorts of BIIB054 (range 1-135 mg/kg) or placebo, administered intravenously; Parkinson's disease participants received a single dose of BIIB054 (15 or 45 mg/kg) or placebo. All participants were evaluated for 16 weeks with clinical, neuroimaging, electrocardiogram, and laboratory assessments. Serum and cerebrospinal fluid BIIB054 concentrations were measured. BIIB054/α-synuclein complexes were measured in plasma. RESULTS Most adverse events were mild and assessed by investigators as unrelated to the study drug. Pharmacokinetic parameters for volunteers and the Parkinson's disease participants were similar. BIIB054 serum exposure and maximum concentrations were dose proportional during the dose range studied. In volunteers and the Parkinson's disease participants, the serum half-life of BIIB054 was 28 to 35 days; the cerebrospinal fluid-to-serum ratio ranged from 0.13% to 0.56%. The presence of BIIB054/α-synuclein complexes in plasma was confirmed; all Parkinson's disease participants showed almost complete saturation of the BIIB054/α-synuclein complex formation. CONCLUSIONS BIIB054 has favorable safety, tolerability, and pharmacokinetic profiles in volunteers and Parkinson's disease participants, supporting further clinical development. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.",2019,"The presence of BIIB054/α-synuclein complexes in plasma was confirmed; all Parkinson's disease participants showed almost complete saturation of the BIIB054/α-synuclein complex formation. ","[""volunteers and Parkinson's disease participants"", ""volunteers and the Parkinson's disease participants"", ""48 healthy volunteers (age 40-65, 19 women) and 18 Parkinson's disease participants (age 47-75, 5 women, Hoehn and Yahr stage ≤2.5"", ""healthy volunteers and participants with Parkinson's disease""]",['placebo'],"['Serum and cerebrospinal fluid BIIB054 concentrations', 'cerebrospinal fluid-to-serum ratio', 'BIIB054/α-synuclein complexes', 'safety, tolerability, and pharmacokinetics', 'BIIB054 serum exposure and maximum concentrations', 'Pharmacokinetic parameters', 'favorable safety, tolerability, and pharmacokinetic profiles']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007807'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0165073', 'cui_str': 'Synucleins'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",48.0,0.168373,"The presence of BIIB054/α-synuclein complexes in plasma was confirmed; all Parkinson's disease participants showed almost complete saturation of the BIIB054/α-synuclein complex formation. ","[{'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Brys', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fanning', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Hung', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ellenbogen', 'Affiliation': 'Michigan Institute for Neurological Disorders, Farmington Hills, Michigan, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Penner', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Welch', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Koenig', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'David', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Fox', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Shavy', 'Initials': 'S', 'LastName': 'Makh', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Aldred', 'Affiliation': 'Selkirk Neurology & Inland Northwest Neurological, Spokane, Washington, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Goodman', 'Affiliation': 'The Compass Clinic, Orlando, Florida, USA.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Pepinsky', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'YuTing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Weihofen', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jesse M', 'Initials': 'JM', 'LastName': 'Cedarbaum', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27738'] 1609,31476757,The Effect of Resin Infiltration on the Progression of Proximal Caries Lesions: A Randomized Clinical Trial.,"OBJECTIVE The aim of this clinical trial was to assess the effect of resin infiltration on the progression of proximal caries lesions. SUBJECTS AND METHODS Forty-one patients, aged between 15 and 33 years, with 2 or more non-cavitated proximal caries lesions were included. In 41 of the adolescent and young adults, 45 pairs of proximal lesions with radiological extension into the inner and outer half of the enamel, or into the outer third of the dentin, were randomly allocated to the test groups (resin infiltration application + fluoridated toothpaste and flossing use) or to the control group (fluoridated toothpaste and flossing use). Standardized geometrically aligned digital bitewing radiographs were obtained using individual biting holders. The radiographic progression of the lesions was assessed after 1 year by digital-subtraction radiography. The McNemar test was used for statistical analysis. RESULTS In the test group 1/45 of the lesions (2.2%) and in the control group 9/45 of the lesions (20%) showed progression. The caries progression rate of the control group was significantly higher than that of the test group (p < 0.05). CONCLUSIONS Resin infiltration of proximal caries lesions is effective in reducing progression of the lesion.",2020,"The caries progression rate of the control group was significantly higher than that of the test group (p< 0.05). ","['In 41 of the adolescent and young adults 45 pairs of proximal lesions with radiological extension into the inner and outer half of the enamel, or into the outer third of the dentin', 'Forty-one patients, aged 15 to 33 years, with 2 or more non-cavitated proximal caries lesions were included']","['test groups (resin infiltration application + fluoridated toothpaste and flossing use) or to the control group (fluoridated toothpaste and flossing use', 'resin infiltration', 'Resin Infiltration']","['radiographic progression of the lesions', 'caries progression rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}]",41.0,0.0412558,"The caries progression rate of the control group was significantly higher than that of the test group (p< 0.05). ","[{'ForeName': 'Soley', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Erciyes University, Kayseri, Turkey, soley@erciyes.edu.tr.'}, {'ForeName': 'Melek Hilal', 'Initials': 'MH', 'LastName': 'Kaplan', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000503053'] 1610,31623958,Effects of flexibility and strength interventions on optimal lengths of hamstring muscle-tendon units.,"OBJECTIVES The aim of the present study was to determine the effects of altering both hamstring flexibility and strength on hamstring optimal lengths. DESIGN Controlled laboratory study. METHODS A total of 20 male and 20 female college students (aged 18-24 years) participated in this study and were randomly assigned to either a flexibility intervention group or a strength intervention group. Passive straight leg raise and isokinetic strength test were performed before and after interventions. Paired T-tests were performed to determine hamstring flexibility or strength intervention effects on hamstring optimal lengths. RESULTS Male participants in the flexibility intervention group significantly increased range of hip joint flexion (P=0.001) and optimal lengths of semimembranosus and biceps long head (P≤0.026). Male participants in the strength intervention group significantly increased hamstring strength (P=0.001), the range of hip joint flexion (P=0.037), and optimal lengths of all three bi-articulated hamstring muscles (P≤0.041). However, female participants did not significantly increase their hamstring optimal lengths in either intervention groups (P≥0.097) although both groups significantly increased the range of hip joint flexion and strength (P≤0.009). CONCLUSION Hamstring optimal lengths can be modified through flexibility intervention as well as strength intervention for male participants, but not for female participants in this study. Hamstring optimal lengths should be considered as hamstring flexibility measures in future prospective studies to identify potentially modifiable risk factors for hamstring injury.",2020,"RESULTS Male participants in the flexibility intervention group significantly increased range of hip joint flexion (P=0.001) and optimal lengths of semimembranosus and biceps long head (P≤0.026).","['hamstring muscle-tendon units', 'male participants', '20 male and 20 female college students (aged 18-24 years', 'Male participants in the']","['flexibility and strength interventions', 'flexibility intervention', 'flexibility intervention group or a strength intervention group', 'strength intervention']","['range of hip joint flexion', 'hamstring strength', 'hamstring optimal lengths', 'optimal lengths of semimembranosus and biceps long head', 'range of hip joint flexion and strength']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}]",,0.0170704,"RESULTS Male participants in the flexibility intervention group significantly increased range of hip joint flexion (P=0.001) and optimal lengths of semimembranosus and biceps long head (P≤0.026).","[{'ForeName': 'Shangxiao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, China.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Garrett', 'Affiliation': 'Duke University Sports Medicine Center, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Best', 'Affiliation': 'Miami Sports Medicine Institute, University of Miami, USA.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, China.'}, {'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, China. Electronic address: liuhuibupe@163.com.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Center for Human Movement Science, The University of North Carolina at Chapel Hill, USA. Electronic address: byu@med.unc.edu.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.09.017'] 1611,30826311,Efficacy of topical clotrimazole vs. topical tolnaftate in the treatment of otomycosis. A randomized controlled clinical trial.,"INTRODUCTION Otomycosis, an infection of the ear canal by fungi, is prevalent in hot and humid weather. Nevertheless, there is not sufficient evidence for the effectiveness of different topical antifungal treatments. Tolnaftate, is a topical antifungal agent described to be effective in the treatment of otomycosis. Currently there are not sufficient studies that prove its efficacy. OBJECTIVES To compare the efficacy of clotrimazole and tolnaftate administration in the treatment of otomycosis. MATERIAL AND METHODS A controlled, randomized and open clinical trial included patients diagnosed with fungal external otitis who were treated with topical antifungals, randomized into two treatment groups: (1) clotrimazole cream; (2) tolnaftate solution. They were microscopically evaluated at one and two weeks of treatment to determine resolution of disease. Recurrence and complications were recorded. Demographic and clinical variables were collected and analyzed. Follow-up and final outcomes (absence of infection) were compared between groups. RESULTS Forty eight patients were included, 28 in the clotrimazole group and 20 in the tolnaftate group. Spring was the weather most commonly associated with otomycosis, while otic manipulation was the risk factor more common in both groups. Predominant symptoms were itching and otic fullness. Aspergillus niger organism was isolated most frequently. Treatment with clotrimazole resulted in 75% resolution vs 45% resolution with treatment with tolnaftate at one week of treatment (p=0.007). The Tolnaftate treatment group demonstrated higher recurrence rates and treatment failures, 20% and 15% respectively. CONCLUSIONS Clotrimazole cream treatment is more effective than tolnaftate for uncomplicated otomycosis. More studies are needed to corroborate our results.",2020,"The Tolnaftate treatment group demonstrated higher recurrence rates and treatment failures, 20% and 15% respectively. ","['Forty eight patients were included, 28 in the Clotrimazole group and 20 in the Tolnaftate group', 'patients diagnosed with fungal external otitis who were treated with']","['topical clotrimazole vs. topical tolnaftate', 'clotrimazole', 'topical antifungals', 'Clotrimazole cream']","['itching and otic fullness', 'recurrence rates and treatment failures', 'Recurrence and complications']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040379', 'cui_str': 'Tolnaftate'}, {'cui': 'C0029878', 'cui_str': 'External Otitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0040379', 'cui_str': 'Tolnaftate'}, {'cui': 'C4552580', 'cui_str': 'Antifungal (disposition)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C4521969', 'cui_str': 'Otic'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0162643'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",48.0,0.127742,"The Tolnaftate treatment group demonstrated higher recurrence rates and treatment failures, 20% and 15% respectively. ","[{'ForeName': 'Lesly', 'Initials': 'L', 'LastName': 'Jimenez-Garcia', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Celis-Aguilar', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico. Electronic address: erikacelis@hotmail.com.'}, {'ForeName': 'Gaudencio', 'Initials': 'G', 'LastName': 'Díaz-Pavón', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Muñoz Estrada', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Mycology Department, Culiacán, Mexico.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Castro-Urquizo', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Nemiliztli', 'Initials': 'N', 'LastName': 'Hernández-Castillo', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Amaro-Flores', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2018.12.007'] 1612,32439860,A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis.,"Gastroenteritis accounts for nearly 500,000 deaths in children younger than 5 years annually. Although probiotics have been touted as having the potential to expedite diarrhea resolution, recent clinical trials question their effectiveness. A potential explanation is a shift in pathogens following the introduction of a rotavirus vaccine. Here, we report the results of a multi-center, double-blind trial of 816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens. Participants were randomized to receive a probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo. We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment. We provide pathophysiological and microbiologic evidence to support the clinical findings and conclude that our data do not support routine probiotic administration to children with acute gastroenteritis, regardless of the infecting virus.",2020,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","['children younger than 5 years annually', '816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens', 'children with acute gastroenteritis']","['combination probiotic', 'probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],816.0,0.233591,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada. Stephen.freedman@ahs.ca.""}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Pang', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chui', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnadower', 'Affiliation': 'University of Cincinnati, 3333 Burnet Ave, Cincinnati, OH, UCA 45229, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schuh', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Sherman', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Bonita E', 'Initials': 'BE', 'LastName': 'Lee', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Université de Montréal, 3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Farion', 'Affiliation': 'University of Ottawa, 401 Smyth Rd, Ottawa, ON, K1H 8L1, Canada.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'University of Western Ontario, 800 Commissioners Road E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Katrina F', 'Initials': 'KF', 'LastName': 'Hurley', 'Affiliation': 'Dalhousie University, 5980 University Avenue, PO Box 9700, Halifax, NS, B3K 6R8, Canada.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Binal', 'Initials': 'B', 'LastName': 'Ghandi', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Lloyd', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-020-16308-3'] 1613,31651335,"Effects of virtual reality-based planar motion exercises on upper extremity function, range of motion, and health-related quality of life: a multicenter, single-blinded, randomized, controlled pilot study.","BACKGROUND Virtual reality (VR)-based rehabilitation is considered a beneficial therapeutic option for stroke rehabilitation. This pilot study assessed the clinical feasibility of a newly developed VR-based planar motion exercise apparatus (Rapael Smart Board™ [SB]; Neofect Inc., Yong-in, Korea) for the upper extremities as an intervention and assessment tool. METHODS This single-blinded, randomized, controlled trial included 26 stroke survivors. Patients were randomized to the intervention group (SB group) or control (CON) group. During one session, patients in the SB group completed 30 min of intervention using the SB and an additional 30 min of standard occupational therapy; however, those in the CON group completed the same amount of conventional occupational therapy. The primary outcome was the change in the Fugl-Meyer assessment (FMA) score, and the secondary outcomes were changes in the Wolf motor function test (WMFT) score, active range of motion (AROM) of the proximal upper extremities, modified Barthel index (MBI), and Stroke Impact Scale (SIS) score. A within-group analysis was performed using the Wilcoxon signed-rank test, and a between-group analysis was performed using a repeated measures analysis of covariance. Additionally, correlations between SB assessment data and clinical scale scores were analyzed by repeated measures correlation. Assessments were performed three times (baseline, immediately after intervention, and 1 month after intervention). RESULTS All functional outcome measures (FMA, WMFT, and MBI) showed significant improvements (p < 0.05) in the SB and CON groups. AROM showed greater improvements in the SB group, especially regarding shoulder abduction and internal rotation. There was a significant effect of time × group interactions for the SIS overall score (p = 0.038). Some parameters of the SB assessment, such as the explored area ratio, mean reaching distance, and smoothness, were significantly associated with clinical upper limb functional measurements with moderate correlation coefficients. CONCLUSIONS The SB was available for improving upper limb function and health-related quality of life and useful for assessing upper limb ability in stroke survivors. TRIAL REGISTRATION The study was registered with the clinical research information service (CRIS) ( KCT0003783 , registered 15 April 2019; retrospectively registered).",2019,"The SB was available for improving upper limb function and health-related quality of life and useful for assessing upper limb ability in stroke survivors. ",['26 stroke survivors'],"['VR-based planar motion exercise apparatus (Rapael Smart Board™ [SB', 'conventional occupational therapy', 'virtual reality-based planar motion exercises', 'intervention group (SB group) or control (CON']","['SIS overall score', 'upper extremity function, range of motion, and health-related quality of life', 'SB assessment data and clinical scale scores', 'All functional outcome measures (FMA, WMFT, and MBI', 'change in the Fugl-Meyer assessment (FMA) score, and the secondary outcomes were changes in the Wolf motor function test (WMFT) score, active range of motion (AROM) of the proximal upper extremities, modified Barthel index (MBI), and Stroke Impact Scale (SIS) score', 'shoulder abduction and internal rotation']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}]",,0.0676936,"The SB was available for improving upper limb function and health-related quality of life and useful for assessing upper limb ability in stroke survivors. ","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Myoung-Hwan', 'Initials': 'MH', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chonbuk National University Medical School, Jeonju, South Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Yeong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Yeajin', 'Initials': 'Y', 'LastName': 'Ham', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hyoseok', 'Initials': 'H', 'LastName': 'Yi', 'Affiliation': 'Neofect, Yong-in, South Korea.'}, {'ForeName': 'Younggeun', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Neofect, Yong-in, South Korea.'}, {'ForeName': 'Dokyeong', 'Initials': 'D', 'LastName': 'Ha', 'Affiliation': 'Neofect, Yong-in, South Korea.'}, {'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea. asfreelyas@gmail.com.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0595-8'] 1614,31462766,Reward related ventral striatal activity and differential response to sertraline versus placebo in depressed individuals.,"Medications to treat major depressive disorder (MDD) are not equally effective across patients. Given that neural response to rewards is altered in MDD and given that reward-related circuitry is modulated by dopamine and serotonin, we examined, for the first time, whether reward-related neural activity moderated response to sertraline, an antidepressant medication that targets these neurotransmitters. A total of 222 unmedicated adults with MDD randomized to receive sertraline (n = 110) or placebo (n = 112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task. We tested whether an index of reward system function in the ventral striatum (VS), a key reward circuitry region, moderated differential response to sertraline versus placebo, assessed with the Hamilton Rating Scale for Depression (HSRD) over 8 weeks. We observed a significant moderation effect of the reward index, reflecting the temporal dynamics of VS activity, on week-8 depression levels (Fs ≥ 9.67, ps ≤ 0.002). Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms. Thus, a more abnormal pattern of pretreatment VS dynamic response to reward expectancy (expected outcome value) and prediction error (difference between expected and actual outcome), likely reflecting serotonergic and dopaminergic deficits, was associated with better response to sertraline than placebo. Pretreatment measures of reward-related VS activity may serve as objective neural markers to advance efforts to personalize interventions by guiding individual-level choice of antidepressant treatment.",2020,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","['depressed individuals', '222 unmedicated adults with MDD randomized to receive']","['placebo (n\u2009=\u2009112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task', 'sertraline', 'placebo', 'sertraline versus placebo']","['Hamilton Rating Scale for Depression (HSRD', 'depression symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",222.0,0.129786,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","[{'ForeName': 'Tsafrir', 'Initials': 'T', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. greenbergt@upmc.edu.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Stiffler', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Toups', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Peltier', 'Affiliation': 'Functional MRI Laboratory, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Departments of Psychiatry and Behavioral Science & Radiology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0490-5'] 1615,31781724,Physical Function and Strength in Relation to Inflammation in Older Adults with Obesity and Increased Cardiometabolic Risk.,"BACKGROUND Inflammation is implicated in functional decline and the development of disability in aging. This study aimed to investigate the association of inflammation with physical function and muscle strength in older adults with obesity and increased cardiometabolic risk. DESIGN In baseline assessments from the CROSSROADS randomized controlled trial, serum interleukin-6 (IL-6), tumor necrosis factor-α (TNFα) and C-reactive protein (hs-CRP) were assayed in 163 older adults (37% males, 24% African American, BMI 34±3, age 70±5yrs) with hypertension, dyslipidemia and/or diabetes. Physical function was assessed by six-minute walk test (6MWT), chair sit-and-reach (CSR), hand-grip and knee-extension strength; specific-strength as muscle strength/mass ratio. Analyses included ANCOVA and multiple linear regression adjusted for thigh skeletal muscle (MRI), arm lean mass (DXA) and moderate-to-vigorous intensity physical activity (MVPA; accelerometry). RESULTS Higher hs-CRP (p<0.01) and IL-6 (p=0.07) were associated with lower 6MWT and CSR, respectively. A composite inflammation score combining all 3 inflammatory markers showed the strongest inverse association with 6MWT (p<0.01). MVPA moderated associations such that amongst participants who engaged in low MVPA, 6MWT distances and CSR scores were significantly lower in those with high IL-6 and TNFα (p<0.05), respectively. In participants with high MVPA, higher hs-CRP (p<0.05) and TNFα (p=0.07) were associated with poorer upper-extremity specific-strength. CONCLUSIONS Chronic inflammation was associated with poorer physical function and specific strength in older adults with obesity and increased cardiometabolic risk. This association was strongest in participants with multiple elevated inflammatory markers. Physical activity levels below current recommendations mitigated the deleterious effects of inflammation on lower body mobility, underscoring the benefits of exercise for preserving physical function with age.",2019,"In participants with high MVPA, higher hs-CRP (p<0.05) and TNFα (p=0.07) were associated with poorer upper-extremity specific-strength. ","['participants with multiple elevated inflammatory markers', 'Older Adults with Obesity and Increased Cardiometabolic Risk', 'older adults with obesity and increased cardiometabolic risk', '163 older adults (37% males, 24% African American, BMI 34±3, age 70±5yrs) with hypertension, dyslipidemia and/or diabetes']",[],"['six-minute walk test (6MWT), chair sit-and-reach (CSR), hand-grip and knee-extension strength; specific-strength as muscle strength/mass ratio', 'physical function and specific strength', 'IL-6', '6MWT distances and CSR scores', 'poorer upper-extremity specific-strength', 'serum interleukin-6 (IL-6), tumor necrosis factor-α (TNFα) and C-reactive protein (hs-CRP', 'Physical function', 'ANCOVA and multiple linear regression adjusted for thigh skeletal muscle (MRI), arm lean mass (DXA) and moderate-to-vigorous intensity physical activity (MVPA; accelerometry']","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],"[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]",163.0,0.0521846,"In participants with high MVPA, higher hs-CRP (p<0.05) and TNFα (p=0.07) were associated with poorer upper-extremity specific-strength. ","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tay', 'Affiliation': 'Jeannie Tay, Department of Nutrition Sciences, University of Alabama at Birmingham, 514 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360, USA. Email: jeantay@uab.edu.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Goss', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Locher', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gower', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1260-4'] 1616,31735634,Are Dilated Fundus Examinations Needed for OCT-Guided Retreatment of Exudative Age-Related Macular Degeneration?,"PURPOSE To determine whether presence of macular hemorrhage on dilated fundus examination (DFE) or fundus photography influences vision outcomes with OCT-guided pro re nata (PRN) ranibizumab retreatment in patients with neovascular age-related macular degeneration (nAMD), we investigated whether hemorrhage without OCT-detectable fluid impacted vision outcomes. DESIGN Post hoc analysis of prospectively collected data from the 24-month pHase III, double-masked, multicenter, randomized, Active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0 mg Ranibizumab administered monthly or on an as-needed Basis (PRN) in patients with subfoveal neOvascular age-related macular degeneration (HARBOR) trial (ClinicalTrials.gov identifier, NCT00891735). PARTICIPANTS This post hoc analysis examined 1097 patients from the intention-to-treat population of HARBOR. METHODS Dilated fundus examination and fundus photography were evaluated for hemorrhage, and spectral-domain (SD) OCT images from HARBOR participants were analyzed for macular fluid secondary to macular neovascularization. Agreement between methods was determined for each time point. Visual outcomes were evaluated for 82 patients with evidence of hemorrhage on DFE or fundus photography at 3 months and no evidence of SD-exudative activity requiring retreatment at month 3. MAIN OUTCOME MEASURES Pooled data from the intention-to-treat population of HARBOR were analyzed for hemorrhage on DFE or fundus photography and exudative activity on SD OCT. A subgroup of PRN patients were analyzed for best-corrected visual acuity gains at 24 months. RESULTS Most study eyes (89% [973/1095]) showed macular hemorrhages at baseline, declining to 31% (319/1042) at month 3 and stabilizing at 11% (111/989) by month 6 of follow-up. After baseline, exudative activity was detected on SD-OCT in more than 89% of eyes when hemorrhage was present on DFE or fundus photography. Patients not requiring a month 3 PRN ranibizumab injection achieved similar visual gains over 24 months, regardless of month 3 hemorrhage presence versus absence: 9.4 and 8.7 Early Treatment Diabetic Retinopathy Study letter scores, respectively (P = 0.74). CONCLUSIONS After 3 initial ranibizumab injections, SD-OCT detected nAMD activity in 89% of eyes when hemorrhage was present on fundus photography. Ranibizumab retreatment guided by monthly SD-OCT achieved similar vision gains with or without injection when hemorrhage was present without OCT-detectable fluid. This suggests that macular hemorrhages without OCT-detectable macular fluid may not require treatment and DFE may not be needed at every visit. These conclusions should be confirmed in a prospective randomized trial before firm recommendations regarding clinical practice can be made.",2020,Ranibizumab retreatment guided by monthly SD-OCT achieved similar vision gains with or without injection when hemorrhage was present without OCT-detectable fluid.,"['patients with neovascular age-related macular degeneration (nAMD', '1097 patients from the intention-to-treat population of HARBOR', '82 patients with evidence of hemorrhage on DFE or fundus photography', 'patients with subfoveal neOvascular age-related macular degeneration (HARBOR']","['Ranibizumab', 'Ranibizumab administered monthly or on an as-needed Basis (PRN', 'OCT-guided pro re nata (PRN) ranibizumab retreatment']","['SD-OCT', 'similar visual gains', 'visual acuity gains', 'efficacy and safety', 'SD-OCT detected nAMD activity', 'vision gains', 'hemorrhage on DFE or fundus photography and exudative activity on SD OCT', 'macular hemorrhages', 'exudative activity', 'Visual outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography (procedure)'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal (qualifier value)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0558288', 'cui_str': 'prn'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0067792', 'cui_str': 'NATA'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography (procedure)'}, {'cui': 'C0311438', 'cui_str': 'Exudative (qualifier value)'}]",1097.0,0.435633,Ranibizumab retreatment guided by monthly SD-OCT achieved similar vision gains with or without injection when hemorrhage was present without OCT-detectable fluid.,"[{'ForeName': 'Yogin', 'Initials': 'Y', 'LastName': 'Patel', 'Affiliation': 'Cincinnati Eye Institute, Cincinnati, Ohio.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Miller', 'Affiliation': 'Cincinnati Eye Institute, Cincinnati, Ohio. Electronic address: dmiller@CincinnatiEye.com.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Fung', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.09.006'] 1617,12200889,ORACLE--antibiotics for preterm prelabour rupture of the membranes: short-term and long-term outcomes.,"UNLABELLED Preterm prelabour rupture of the foetal membranes (pPROM) is the most common antecedent of preterm birth and can lead to death, neonatal disease and long-term disability. Previous small trials of antibiotics for pPROM suggested some health benefits for the neonate, but the results were inconclusive. A large, randomized, multicentre trial was undertaken to try to resolve this issue. In total, 4826 women with pPROM were randomized to one of four treatments: 325 mg co-amoxiclav plus 250 mg erythromycin, co-amoxiclav plus erythromycin placebo, erythromycin plus co-amoxiclav placebo, or co-amoxiclav placebo plus erythromycin placebo, four times daily for 10 d or until delivery. The primary outcome measure was a composite of neonatal death, chronic lung disease or major cerebral abnormality on ultrasonography before discharge from hospital. The analysis was undertaken by intention to treat. Indications of short-term respiratory function, chronic lung disease and major neonatal cerebral abnormality were reduced with the prescription of erythromycin. In contrast, the use of co-amoxiclav was associated with a significant increase in the occurrence of neonatal necrotizing enterocolitis. CONCLUSION Prophylactic antibiotics can play a role in preterm prelabour rupture of the membranes in reducing infant morbidity.",2002,"Indications of short-term respiratory function, chronic lung disease and major neonatal cerebral abnormality were reduced with the prescription of erythromycin.",['4826 women with pPROM'],"['erythromycin', '325 mg co-amoxiclav plus 250 mg erythromycin, co-amoxiclav plus erythromycin placebo, erythromycin plus co-amoxiclav placebo, or co-amoxiclav placebo plus erythromycin placebo']","['chronic lung disease and major neonatal cerebral abnormality', 'occurrence of neonatal necrotizing enterocolitis', 'composite of neonatal death, chronic lung disease or major cerebral abnormality on ultrasonography before discharge from hospital']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0729264', 'cui_str': 'PPROM'}]","[{'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}]",4826.0,0.450396,"Indications of short-term respiratory function, chronic lung disease and major neonatal cerebral abnormality were reduced with the prescription of erythromycin.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kenyon', 'Affiliation': 'ORACLE Clinical Co-ordinating Centre, Department of Obstetrics, Clinical Sciences Building, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, UK. oracle@ie.ac.uk'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'W O', 'Initials': 'WO', 'LastName': 'Tarnow-Mordi', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992). Supplement",[] 1618,31422858,A multicenter randomized controlled trial of a modified Valsalva maneuver for cardioversion of supraventricular tachycardias.,"CLINICAL QUESTION Valsalva maneuver is a recognized treatment for supraventricular tachycardia, but in clinical setting it has a low chance to achieve successful cardioversion. Studies suggested that the postural modification of valsalva maneuver may improve the rate of cardioversion. We further modified the maneuver and conduct a multicenter randomized controlled trial to test its efficacy. RESEARCH IN CONTEXT Appelboam A, Reuben A, Mann C, et al. Postural modification of the standard Valsalva maneuver for emergency treatment for supraventricular tachycardias (REVERT): a randomized controlled trial. Lancet 2015; 386 (10005):1747-53 [1]. Allison Michaud, PhD, Eddy Lang. Leg lift Valsalva maneuver for treatment of supraventricular tachycardias. CJEM 2017; 19(3):235-237 [2]. OBJECTIVE To verify the efficacy of the modified Valsalva maneuver in SVT in Chinese population and simplify the operation process further.",2020,Postural modification of the standard Valsalva maneuver for emergency treatment for supraventricular tachycardias (REVERT): a randomized controlled trial.,['supraventricular tachycardias (REVERT'],"['modified Valsalva maneuver', 'standard Valsalva maneuver', 'Leg lift Valsalva maneuver', 'modified Valsalva maneuver in SVT']",['rate of cardioversion'],"[{'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}]","[{'cui': 'C0042293', 'cui_str': 'Valsalva Maneuver'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}]","[{'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}]",,0.0422851,Postural modification of the standard Valsalva maneuver for emergency treatment for supraventricular tachycardias (REVERT): a randomized controlled trial.,"[{'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Cardiac Center, Beijing Chaoyang Hospital affiliated to Capital Medical University, China; Jiangsu People's Hospital of Xuzhou branch (Xuzhou Third People's Hospital), China. Electronic address: doctorchenchaofeng@163.com.""}, {'ForeName': 'Tsz Kin', 'Initials': 'TK', 'LastName': 'Tam', 'Affiliation': 'Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': ""Shanxi provincial people's hospital, China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Jiangsu People's Hospital of Xuzhou branch (Xuzhou Third People's Hospital), China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Teng', 'Affiliation': 'Xuzhou mine hospital, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Xuzhou mine hospital, China.'}, {'ForeName': 'Liujian', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Shanghai prison general hospital, China.'}, {'ForeName': 'Xingpeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Cardiac Center, Beijing Chaoyang Hospital affiliated to Capital Medical University, China. Electronic address: xpliu71@vip.sina.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158371'] 1619,32439224,Effect of Vehicle and Agitation Methods on the Penetration of Calcium Hydroxide Paste in the Dentinal Tubules.,"INTRODUCTION The aim of this ex vivo study was to analyze the effect of different vehicles combined with agitation methods on the penetration of calcium hydroxide (CH) paste in the dentinal tubules. METHODS Sixty freshly extracted, single-rooted human premolars were prepared using WaveOne Gold (Dentsply Sirona, York, PA) and randomized into 6 experimental groups (n = 10) according to the vehicle and method of paste agitation as follows: propylene glycol (PG) + Lentulo, PG + Lentulo + ultrasound, PG + Lentulo + sonic, distilled water (DW) + Lentulo, DW + Lentulo + ultrasonic, and DW + Lentulo + sonic. The CH paste was manipulated with sodium fluorescein dye and was inserted to completely fill the root canal. Two 1-mm thick sections at 2 mm and 5 mm from the apex of each root were obtained. The sections were scanned using confocal laser scanning microscopy, and the images were analyzed using ImageJ software (Bethesda, MD) to calculate the percentage penetration and maximum penetration depth of CH paste. Statistical analysis was performed using 1-way analysis of variance and Tukey honestly significant difference post hoc tests. RESULTS No statistically significant differences between study factors at a distance of 2 mm from the apex were observed (P > .05). However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG. CONCLUSIONS Vehicles interfered with the penetration of CH in the dentinal tubules at 5 mm from the apex with better results for PG.",2020,"However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG. ","['Sixty freshly extracted, single-rooted human premolars']","['Vehicle and Agitation Methods', 'sodium fluorescein dye', 'WaveOne Gold (Dentsply Sirona, York, PA', 'calcium hydroxide', 'paste agitation as follows: propylene glycol (PG) + Lentulo, PG + Lentulo + ultrasound, PG + Lentulo + sonic, distilled water (DW) + Lentulo, DW + Lentulo + ultrasonic, and DW + Lentulo + sonic']",['Penetration of Calcium Hydroxide Paste'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0147866', 'cui_str': 'Fluorescein sodium stain'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]",60.0,0.0523159,"However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG. ","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'de Almeida Barbosa', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Kauhanna Vianna', 'Initials': 'KV', 'LastName': 'de Oliveira', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Vinícius Rodrigues', 'Initials': 'VR', 'LastName': 'Dos Santos', 'Affiliation': 'Piracicaba Dental School, Universidade Estadual de Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Wander José', 'Initials': 'WJ', 'LastName': 'da Silva', 'Affiliation': 'Piracicaba Dental School, Universidade Estadual de Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Flávia Sens Fagundes', 'Initials': 'FSF', 'LastName': 'Tomazinho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Flares', 'Initials': 'F', 'LastName': 'Baratto-Filho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Marilisa Carneiro Leão', 'Initials': 'MCL', 'LastName': 'Gabardo', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil. Electronic address: marilisagabardo@gmail.com.'}]",Journal of endodontics,['10.1016/j.joen.2020.03.026'] 1620,32439422,Development and piloting of a blended learning training programme for physicians and medical students to enhance their competences in evidence-based decision-making.,"INTRODUCTION In 2016, the German Network for Evidence-based Medicine revised its basic curriculum for competences in evidence-based medicine. A curriculum-based training programme for physicians and medical students to enhance their competences in evidence-based decision-making was developed. The training programme was planned on the basis of problem-based learning. The aim of this qualitative pilot study was to explore the feasibility and acceptability of the training programme. Hypotheses concerning its influence on critical health literacy and the attitude toward evidence-based decision-making were to be generated. METHODS Participating healthcare professionals received a structured training in a blended learning format. Data collection was conducted during the training sessions. The lessons were observed and protocolled and the working results were documented. Two focus group interviews were conducted after the training blocks with focus on acceptability and feasibility of the training programme. Interview transcripts and protocols were analysed using qualitative content analysis according to Mayring. Data saturation was intended by an iterative process of testing, analysing and revising the training programme. In addition, critical health literacy was assessed using the validated Critical Health Competence test. Levels of competence were calculated to measure the effect of the training on critical health competences. RESULTS Two pilot courses with 29 physicians and other healthcare professionals were conducted between January and March 2019. Overall, the training programme proved to be feasible. The participants rated the comprehensibility of the learning modules as high. However, the practical exercises (e.g. role plays in shared decision-making) revealed that relevant subjects were insufficiently understood (e.g. the difference between the benefits and harms of a diagnostic test and its test accuracy). The interactive instructional design was appreciated. The participants appraised the work tasks as comprehensible but also challenging and requested a theoretical introduction to statistical terms in preparation for work tasks. The programme was revised iteratively according to the results. Critical health competences increased significantly after the training. Mean values (±SD) of levels of competence were 571.21 (±82.87) before training and 671.90 (±51.38) after training (p<0.0001) (levels of competence with a range from 0 to 1,000). CONCLUSION The training programme is feasible and was well accepted by the participants. It should be established as a continuing medical education opportunity for practitioners. Evaluation in a randomised controlled trial is recommended. Furthermore, the training can easily be adapted for interprofessional training. A concept for long-term implementation is needed.",2020,Critical health competences increased significantly after the training.,"['physicians and medical students', 'Participating healthcare professionals', '29 physicians and other healthcare professionals were conducted between January and March 2019']","['curriculum-based training programme', 'structured training in a blended learning format', 'blended learning training programme']","['feasibility and acceptability', 'Critical health competences', 'Mean values (±SD) of levels of competence']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0398525,Critical health competences increased significantly after the training.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hinneburg', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: jana.hinneburg@medizin.uni-halle.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hecht', 'Affiliation': 'School of Nursing Science, Faculty of Health, University of Witten/Herdecke, Witten/Herdecke, Germany. Electronic address: hecht@red-institut.de.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Buhse', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lühnen', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Steckelberg', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}]","Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen",['10.1016/j.zefq.2020.02.004'] 1621,31468650,Lactate infusion increases brain energy content during euglycemia but not hypoglycemia in healthy men.,"A special characteristic of the brain is the usage of lactate as alternative fuel instead of glucose to preserve its energy homeostasis. This physiological function is valid for sufficient cerebral glucose supply, as well as presumably during hypoglycemia, given that exogenous lactate infusion suppresses hormonal counterregulation. However, it is not yet clarified whether this effect is mediated by the use of lactate as an alternative cerebral energy substrate or any other mechanism. We hypothesized that under conditions of limited access to glucose (ie, during experimental hypoglycemia) lactate infusion would prevent hypoglycemia-induced neuroenergetic deficits in a neuroprotective way. In a randomized, double-blind, crossover study, lactate vs placebo infusion was compared during hyperinsulinemic-hypoglycemic clamps in 16 healthy young men. We measured the cerebral high-energy phosphate content - ie, adenosine triphosphate (ATP), phosphocreatine (PCr) and inorganic phosphate (Pi) levels - by 31 P-magnetic resonance spectroscopy as well as the neuroendocrine stress response. During euglycemia, lactate infusion increased ATP/Pi as well as PCr/Pi ratios compared with baseline values and placebo infusion. During hypoglycemia, there were no differences between the lactate and the placebo condition in both ratios. Hormonal counterregulation was significantly diminished upon lactate infusion. Our data demonstrate an elevated cerebral high-energy phosphate content upon lactate infusion during euglycemia, whereas there was no such effect during experimental hypoglycemia. Nevertheless, lactate infusion suppressed hypoglycemic hormonal counterregulation. Lactate thus adds to cerebral energy provision during euglycemia and may contribute to an increase in ATP reserves, which in turn protects the brain against neuroglucopenia under recurrent hypopglycemic conditions, eg, in diabetic patients.",2019,"During euglycemia, lactate infusion increased ATP/Pi as well as PCr/Pi ratios compared with baseline values and placebo infusion.","['16 healthy young men', 'diabetic patients', 'healthy men']","['hyperinsulinemic-hypoglycemic clamps', 'Lactate infusion', 'lactate vs placebo']","['cerebral high-energy phosphate content\xa0-\xa0ie, adenosine triphosphate (ATP), phosphocreatine (PCr) and inorganic phosphate (Pi) levels\xa0', 'hypoglycemic hormonal counterregulation', 'Hormonal counterregulation', 'euglycemia, lactate infusion increased ATP/Pi as well as PCr/Pi ratios']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0523827', 'cui_str': 'Phosphate, inorganic measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",16.0,0.0681699,"During euglycemia, lactate infusion increased ATP/Pi as well as PCr/Pi ratios compared with baseline values and placebo infusion.","[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Doerte', 'Initials': 'D', 'LastName': 'Rabe', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duysen', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Uwe H', 'Initials': 'UH', 'LastName': 'Melchert', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}]",NMR in biomedicine,['10.1002/nbm.4167'] 1622,32006613,"An Individualized, Interactive, and Advance Care Planning Intervention Promotes Transitions in Prognostic Awareness States Among Terminally Ill Cancer Patients in Their Last Six Months-A Secondary Analysis of a Randomized Controlled Trial.","CONTEXT/OBJECTIVES To examine whether an advance care planning intervention randomized controlled trial facilitates terminally ill cancer patients' transitions to accurate prognostic awareness (PA) and the time spent in the accurate PA state in patients' last six months. METHODS Participants (N = 460) were randomized 1:1 to experimental (interactive intervention tailored to participants' readiness for advance care planning/prognostic information) and control (symptom management education) arms with similar formats. PA was categorized into four states: 1) unknown and not wanting to know; 2) unknown but wanting to know; 3) inaccurate awareness; and 4) accurate awareness. Intervention effectiveness in the two outcomes was evaluated by intention-to-treat analysis with multistate Markov modeling (effect size ≥0.2 as minimal clinically important difference). RESULTS The final sample constituted 188 and 184 experimental arm and control arm participants who died and were repeatedly assessed, respectively. Experimental arm participants in States 1-3 had a higher probability of shifting to accurate PA (23.0%-35.4% vs. 15.2%-26.2%) than control arm participants, and all effect sizes met the minimal clinically important difference criterion (effect sizes 0.22-0.49). In their last six months, experimental arm participants spent more time in States 3 and 4 (0.18 vs. 0.08 and 2.94 vs. 2.38 months, respectively) but less time in States 1 and 2 (2.70 vs. 3.19 and 0.18 vs. 0.36 months, respectively) (effect sizes 0.11-0.19). CONCLUSION Our intervention meaningfully facilitated participants' transition toward accurate PA and more time spent in the accurate PA state (State 4). Our intervention can help health care professionals foster cancer patients' accurate PA earlier in the terminal illness trajectory to make informed end-of-life care decisions tailored to their readiness for prognostic information.",2020,Experimental-arm participants in states 1-3 had a higher probability of shifting to accurate PA (23.0-35.4% vs. 15.2-26.2%) than control-arm participants and all effect sizes met the MCID criterion (effect sizes=0.22-0.49).,"[""ill cancer patients' transitions"", 'Participants (N=460', 'terminally ill cancer patients']","[""experimental (interactive intervention tailored to participants' readiness for ACP/prognostic information) and control (symptom-management education) arms with similar formats"", 'advance-care planning (ACP) intervention', 'individualized, interactive, advance-care planning intervention']","['Intervention effectiveness', 'higher probability of shifting to accurate PA']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}]",460.0,0.0752918,Experimental-arm participants in states 1-3 had a higher probability of shifting to accurate PA (23.0-35.4% vs. 15.2-26.2%) than control-arm participants and all effect sizes met the MCID criterion (effect sizes=0.22-0.49).,"[{'ForeName': 'Chen Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chou', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Chia-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Fur-Hsing', 'Initials': 'FH', 'LastName': 'Wen', 'Affiliation': 'Department of International Business, Soochow University, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Siew Tzuh', 'Initials': 'ST', 'LastName': 'Tang', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China; School of Nursing, Medical College, Chang Gung University, Kwei-Shan, Tao-Yuan, Taiwan, Republic of China; Department of Nursing, Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung, Taiwan, Republic of China. Electronic address: sttang@mail.cgu.edu.tw.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.012'] 1623,31449470,Neoadjuvant Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation Versus Chemoradiation for Locally Advanced Cervical Cancer: A Randomized Phase II Trial.,"PURPOSE Although chemoradiation therapy (CRT) with cisplatin remains the standard treatment of patients with locally advanced cervical cancer (LACC), 40% of patients present with disease recurrence. Additional treatment strategies are required to improve outcomes. We conducted a trial to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine followed by CRT. METHODS In this phase II trial, patients with LACC (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes) were randomly assigned to three cycles of NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life. RESULTS From 107 patients enrolled in the trial, 55 were randomly assigned to the NAC arm and 52 to the CRT-alone arm. The majority of patients had squamous cell carcinoma (87.8%). After a median follow-up of 31.7 months, NAC was associated with an inferior PFS, with 3-year PFS rates of 40.9% v 60.4% in the CRT arm (hazard ratio, 1.84; 95% CI, 1.04 to 3.26; P = .033). NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006). After treatment completion, complete response rates were 56.3% in the NAC arm and 80.3% in the CRT arm ( P = .008). Toxicities were similar in both arms, with the exception of hypomagnesemia and neuropathy being more common with NAC. CONCLUSION This study shows that the addition of NAC consisting of cisplatin and gemcitabine to standard CRT is not superior and is possibly inferior to CRT alone for the treatment of LACC.",2019,"NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006).","['Locally Advanced Cervical Cancer', '107 patients enrolled in the trial, 55', 'patients with LACC (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes', 'patients with locally advanced cervical cancer (LACC']","['NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone', 'neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine', 'Chemoradiation Versus Chemoradiation', 'cisplatin and gemcitabine', 'Neoadjuvant Chemotherapy With Cisplatin and Gemcitabine', 'chemoradiation therapy (CRT) with cisplatin', 'NAC']","['Toxicities', '3-year PFS rates', '3-year progression-free survival (PFS', 'complete response rates', 'efficacy and safety', 'response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life', 'squamous cell carcinoma']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}]",55.0,0.172895,"NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006).","[{'ForeName': 'Samantha Cabral S', 'Initials': 'SCS', 'LastName': 'da Costa', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata Colombo', 'Initials': 'RC', 'LastName': 'Bonadio', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Flavia Carolina G', 'Initials': 'FCG', 'LastName': 'Gabrielli', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Aranha', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Luiza N', 'Initials': 'MLN', 'LastName': 'Dias Genta', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanessa C', 'Initials': 'VC', 'LastName': 'Miranda', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Freitas', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Abdo Filho', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Patrícia A O', 'Initials': 'PAO', 'LastName': 'Ferreira', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Karime K', 'Initials': 'KK', 'LastName': 'Machado', 'Affiliation': 'Hospital Sírio-Libanês, Brasília, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Scaranti', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Heloísa de A', 'Initials': 'HA', 'LastName': 'Carvalho', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Del Pilar', 'Initials': 'MDP', 'LastName': 'Estevez-Diz', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00674'] 1624,31447129,"Efficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial.","PURPOSE Multimodal analgesia with acetaminophen and/or nonsteroidal anti-inflammatory drugs is recommended for the treatment of postoperative pain. Although oral fixed-dose combinations (FDCs) are available, parenteral administration may be clinically justified. The goal of this study was to investigate the clinical efficacy and safety of an intravenous FDC of ibuprofen and acetaminophen after bunionectomy. METHODS This study was a prospective, randomized, double-blind, multicenter, placebo-controlled factorial clinical trial conducted at 2 clinical research centers in the United States between November 2016 and June 2017. Eligible patients (male and female subjects, aged 18-65 years, reporting pain intensity levels ≥40 mm on a 100-mm visual analog scale (VAS) after distal, first metatarsal bunionectomy) were randomized (3:3:3:2) to receive the FDC (ibuprofen 300 mg + acetaminophen 1000 mg), ibuprofen 300 mg, acetaminophen 1000 mg, or placebo (vehicle), administered as 15-minute intravenous infusions every 6 hours for 48 hours. The primary efficacy end point was the time-adjusted sum of pain intensity differences from baseline over 48 hours (SPID 48 ). In addition to VAS pain intensity scores, pain relief scores, time to perceptible and meaningful pain relief, the use of rescue medication, and participant's global evaluations of the study drug were recorded. Adverse events occurring during the 48-hour treatment period were included in the safety analysis. FINDINGS A total of 276 participants were enrolled; most were female (82%), the mean age was 42.4 years, and the median baseline VAS was 67 mm, indicating moderate to severe pain. SPID 48 was significantly higher for the FDC (23.4 [2.5] mm) than for ibuprofen (9.5 [2.5] mm), acetaminophen (10.4 [2.5] mm), and placebo (-1.3 [3.1] mm; all, P < 0.001). The superior analgesic effect of the FDC was supported by a range of secondary end points, including reduced opioid usage rates (75% for FDC, 92% for ibuprofen, 93% for acetaminophen, and 96% for placebo; all, P < 0.005). The safety profile of the FDC was comparable to that of intravenous ibuprofen or acetaminophen alone. Three participants withdrew from the study due to adverse events: 2 in the ibuprofen group and 1 in the acetaminophen group. IMPLICATIONS The study found that repeated administration of an intravenous FDC of ibuprofen and acetaminophen provided statistically significant improvement in SPID 48 over comparable doses of either monotherapy without an increase in adverse events. ClinicalTrials.gov identifier: NCT02689063.",2019,"The superior analgesic effect of the FDC was supported by a range of secondary end points, including reduced opioid usage rates (75% for FDC, 92% for ibuprofen, 93% for acetaminophen, and 96% for placebo; all, P < 0.005).","['Eligible patients (male and female subjects, aged 18-65 years, reporting pain intensity levels ≥40\xa0mm on a 100-mm visual analog scale (VAS) after distal, first metatarsal bunionectomy', 'A total of 276 participants were enrolled; most were female (82%), the mean age was 42.4 years, and the median baseline VAS was 67\xa0mm, indicating moderate to severe pain', '2 clinical research centers in the United States between November 2016 and June 2017']","['acetaminophen', 'placebo', 'ibuprofen 300\xa0mg, acetaminophen 1000\xa0mg, or placebo (vehicle', 'FDC (ibuprofen 300\xa0mg\xa0+\xa0acetaminophen', 'Acetaminophen/Ibuprofen Fixed-dose Combination', 'monotherapy', 'ibuprofen', 'Placebo', 'ibuprofen and acetaminophen']","[""VAS pain intensity scores, pain relief scores, time to perceptible and meaningful pain relief, the use of rescue medication, and participant's global evaluations"", 'reduced opioid usage rates', 'adverse events', 'Adverse events', 'time-adjusted sum of pain intensity differences', 'SPID 48', 'Efficacy and Safety', 'clinical efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0986665', 'cui_str': 'Ibuprofen 300 MG'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C2047874', 'cui_str': 'Acetaminophen / Ibuprofen'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}]",276.0,0.696606,"The superior analgesic effect of the FDC was supported by a range of secondary end points, including reduced opioid usage rates (75% for FDC, 92% for ibuprofen, 93% for acetaminophen, and 96% for placebo; all, P < 0.005).","[{'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Daniels', 'Affiliation': 'Optimal Research LLC, Austin, TX, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playne', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Stanescu', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand. Electronic address: ioana@aftpharm.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand.'}, {'ForeName': 'Ira J', 'Initials': 'IJ', 'LastName': 'Gottlieb', 'Affiliation': 'Chesapeake Research Group, Pasadena, MD, USA.'}, {'ForeName': 'Hartley C', 'Initials': 'HC', 'LastName': 'Atkinson', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.008'] 1625,31473769,Radiofrequency microtenotomy: a promising method for treatment of rotator cuff tendinopathy.,"PURPOSE Subacromial pain syndrome is a common disorder. Arthroscopic subacromial decompression is currently the preferred treatment method. Bipolar radiofrequency microtenotomy has shown promising results in treating tendinosis. In this study, the authors compare the results after arthroscopic acromioplasty with bipolar radiofrequency microtenotomy for patients with subacromial pain syndrome. METHODS A total of 27 patients, with subacromial pain syndrome, were followed for 2 years. There were 14 patients in the arthroscopic acromioplasty group and 13 patients in the radiofrequency microtenotomy group. Clinical outcome data included pain reported using a visual analog scale, Constant score, and strength. Magnetic resonance imaging of the affected shoulder was performed before and 2 years after intervention for an evaluation of the tendinosis grade. RESULTS All patients attended the final follow-up 2 years after intervention. No significant differences were found at baseline between the groups. Pain measured by the visual analog scale revealed a significant reduction in both groups at 12 weeks, 6 months and 2 years compared with baseline. There was no significant difference between the groups in terms of visual analog scale, Constant score, or strength. The magnetic resonance imaging revealed a significant improvement in the tendinosis score in both groups, without any significant difference between the groups. CONCLUSION In this prospective randomized study, the clinical assessments revealed a significant improvement in terms of the visual analog scale, strength, Constant score, and tendinosis score 2 years after intervention with either arthroscopic acromioplasty or radiofrequency microtenotomy in patients with subacromial pain syndrome. However, no significant differences were found between the groups. This study reveals that there are surgical options other than acromioplasty in patients with SAPS. LEVEL OF EVIDENCE II.",2019,"Pain measured by the visual analog scale revealed a significant reduction in both groups at 12 weeks, 6 months and 2 years compared with baseline.","['patients with subacromial pain syndrome', '14 patients in the arthroscopic acromioplasty group and 13 patients in the radiofrequency microtenotomy group', 'patients with SAPS', '27 patients, with subacromial pain syndrome, were followed for 2\xa0years', 'rotator cuff tendinopathy']","['Arthroscopic subacromial decompression', 'arthroscopic acromioplasty or radiofrequency microtenotomy', 'Radiofrequency microtenotomy', 'arthroscopic acromioplasty with bipolar radiofrequency microtenotomy', 'Bipolar radiofrequency microtenotomy']","['visual analog scale, strength, Constant score, and tendinosis score 2\xa0years', 'visual analog scale, Constant score, or strength', 'pain reported using a visual analog scale, Constant score, and strength', 'visual analog scale', 'tendinosis score', 'Pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0408088', 'cui_str': 'Arthroscopic acromioplasty (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}]","[{'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint (procedure)'}, {'cui': 'C0408088', 'cui_str': 'Arthroscopic acromioplasty (procedure)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1568363', 'cui_str': 'Tendinosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0367196,"Pain measured by the visual analog scale revealed a significant reduction in both groups at 12 weeks, 6 months and 2 years compared with baseline.","[{'ForeName': 'Zeiad', 'Initials': 'Z', 'LastName': 'Al-Ani', 'Affiliation': 'Department of Radiology, University Hospital North Norway, 9038, Tromsö, Norway.'}, {'ForeName': 'Eivind Wergeland', 'Initials': 'EW', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Orthopedics, University Hospital North Norway, 9038, Tromsö, Norway.'}, {'ForeName': 'Jüri-Toomas', 'Initials': 'JT', 'LastName': 'Kartus', 'Affiliation': 'Department of Orthopedics, NU-Hospital Group, University of Gothenburg, Trollhättan, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Knutsen', 'Affiliation': 'Department of Orthopedics, University Hospital North Norway, 9038, Tromsö, Norway.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Meknas', 'Affiliation': 'Department of Orthopedics, University Hospital North Norway, 9038, Tromsö, Norway. khaled.meknas@uit.no.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05689-8'] 1626,31473982,The effect of family-centered empowerment program on the family caregiver burden and the activities of daily living of Iranian patients with stroke: a randomized controlled trial study.,"Dependence of stroke survivors regarding the ability to perform activities of daily living imposes a burden on family caregivers. The study evaluated the effect of the family-centered empowerment program on the ability of Iranian patients with stroke to perform activities of daily living, as well as on family caregiver burden. In this randomized controlled trial study, a total of 90 pairs of patients with stroke and their family caregivers was selected and randomly assigned to the intervention or control groups. Patients and their family caregivers participated in four family-centered empowerment program sessions over four consecutive days while the patient was hospitalized. The difference in the ability of patients with stroke in the intervention and control groups to perform activities of daily living was not significant 2 weeks after the intervention. However, the ability of patients with stroke in the intervention group to perform activities of daily living increased significantly 2 months after the intervention compared with the control group: 66 ± 35.95 and 51.31 ± 36.28, respectively (p = 0.047). Two weeks after the intervention, the family caregiver burden significantly decreased in the intervention group (29.55 ± 15.38) compared with the control group (38.77 ± 18.53 and p = 0.012). The burden in the intervention group also decreased 2 months after the intervention compared with the control group: 22.95 ± 15.68 and 36.11 ± 18.88, respectively (p < 0.001). Nurses can use the family-centered empowerment program to improve the quality of life of patients with stroke, and to reduce the burden of family caregivers.",2020,The difference in the ability of patients with stroke in the intervention and control groups to perform activities of daily living was not significant 2 weeks after the intervention.,"['Iranian patients with stroke', '90 pairs of patients with stroke and their family caregivers', 'family caregivers']",['family-centered empowerment program'],"['family caregiver burden', 'perform activities of daily living']","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",90.0,0.0418953,The difference in the ability of patients with stroke in the intervention and control groups to perform activities of daily living was not significant 2 weeks after the intervention.,"[{'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Deyhoul', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Vasli', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran. p-vasli@sbmu.ac.ir.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Rohani', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran.'}, {'ForeName': 'Nezhat', 'Initials': 'N', 'LastName': 'Shakeri', 'Affiliation': 'Department of Biostatistics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meimanat', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01321-4'] 1627,32439861,Physiological and Behavioral Synchrony Predict Group Cohesion and Performance.,"Interpersonal synchrony contributes to social functioning in dyads, but it remains unknown how synchrony shapes group experiences and performance. To this end, we designed a novel group drumming task in which participants matched their drumming to either predictable or unpredictable tempos. Fifty-one three-person groups were randomly assigned to one of two conditions: synchronized or asynchronized drumming. Outcome measures included electrocardiograms and self-reports of group cohesion and synchrony. The drumming task elicited an increase in physiological synchrony between group members (specifically their hearts' interbeat intervals). We also found that physiological synchronization and behavioral synchronization predicted individuals' experience of group cohesion. Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together. The findings suggest that the behavioral and physiological consequences of synchronization contribute to the formation of group bonds and coordination. They also confirm that insights from translational social neuroscience can inform our knowledge of the development of cohesive and efficacious groups.",2020,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"['participants matched their drumming to either predictable or unpredictable tempos', 'Fifty-one three-person groups']",['synchronized or asynchronized drumming'],"['electrocardiograms and self-reports of group cohesion and synchrony', 'physiological synchrony']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0139198,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"[{'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel. Ilanit.gordon@biu.ac.il.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gilboa', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Milstein', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Haimovich', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Pinhasi', 'Affiliation': 'The Psychology Department, Rupin College, Emeq-Hefer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Siegman', 'Affiliation': 'The Department of Computer Science, Bar Ilan University, Ramat-Gan, Israel.'}]",Scientific reports,['10.1038/s41598-020-65670-1'] 1628,32440004,Arm-pull thrust in human swimming and the effect of post-activation potentiation.,"The aim of this study was to analyse the front-crawl arm-pull kinetics and kinematics, comparing it before and after post-activation potentiation (PAP), and the associations between variables describing of the arm-pull kinetics. Twelve male competitive swimmers were randomly assigned to perform two different warm-ups in a crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition). PAP consisted of 2 × 5 arm-pulls with resistance bands by both upper-limbs. Eight minutes later, participants underwent a 25 m all-out trial in front-crawl arm-pull. Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation) were collected by an in-house customised system composed of differential pressure sensors, speedo-meter and underwater camera. There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74). There were non-significant and small effects of PAP on speed (P = 0.307, d = 0.18) and speed fluctuation (P = 0.498, d = 0.04). Correlation coefficients among kinetic variables were significant with large associations (0.51 < R < 0.90, 0.001 < P < 0.088). In conclusion, warm-ups including PAP conditioning sets elicit a large improvement in the thrust, but with small improvement in performance. Variables used to characterise thrust are strongly correlated and hence can be used interchangeably.",2020,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).",['Twelve male competitive swimmers'],['crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition'],"['Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation', 'arm-pull kinetics', 'speed fluctuation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]",12.0,0.0288481,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).","[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore. tiago.barbosa@nie.edu.sg.'}, {'ForeName': 'Jia Wen', 'Initials': 'JW', 'LastName': 'Yam', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Lum', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Govindasamy', 'Initials': 'G', 'LastName': 'Balasekaran', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports, Health and Human Development - CIDESD, Vila Real, Portugal.'}]",Scientific reports,['10.1038/s41598-020-65494-z'] 1629,31430032,Reframing the individual stress response: Balancing our knowledge of stress to improve responsivity to stressors.,"Although responses to stressors have both adverse and positive consequences on health, many believe that stress is entirely negative. Research revealed that negative beliefs about stress can hinder well-being and result in the avoidance of stressors. Stress-optimizing interventions that target various stress appraisal processes may be a useful tool to reframe how individuals understand and respond to stressors. The current study extends previous findings on stress reframing and sought to examine the extent to which the presentation of information about stress outcomes may influence the individual to respond to subsequent stressors. Seventy-seven undergraduate students (96% female) were randomized into one of four reframing conditions (balanced stress outcomes, negative stress outcomes, positive stress outcomes, and control) and underwent a psychosocial stressor. Results highlight similarities between balanced and positive framings of stress across measures of heart rate and blood pressure, whereas subjective ratings of stress and electrodermal activity suggest balanced framing may be efficacious in attenuating stress. Findings are discussed in the context of differing stress-optimizing interventions and consider the complexities of the individual stress response.",2019,Stress-optimizing interventions that target various stress appraisal processes may be a useful tool to reframe how individuals understand and respond to stressors.,['Seventy-seven undergraduate students (96% female'],[],['heart rate and blood pressure'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0135946,Stress-optimizing interventions that target various stress appraisal processes may be a useful tool to reframe how individuals understand and respond to stressors.,"[{'ForeName': 'Jenny Jing Wen', 'Initials': 'JJW', 'LastName': 'Liu', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Reed', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Vickers', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, Ontario, Canada.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2893'] 1630,31466693,"Development of a transdiagnostic, low-intensity, psychological intervention for common adolescent mental health problems in Indian secondary schools.","BACKGROUND The PRIDE programme aims to establish a suite of transdiagnostic psychological interventions organised around a stepped care system in Indian secondary schools. This paper describes the development of a low-intensity, first-line component of the PRIDE model. METHOD Contextual and global evidence informed an intervention 'blueprint' with problem solving as the primary practice element. Successive iterations were tested and modified across two pilot cohort studies (N = 45; N = 39). Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools. RESULTS The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists. However, delivery was not feasible within the intended 6-week schedule, and participants struggled to use materials outside 'guidance' sessions. In Pilot 2, a modified counsellor-led problem-solving intervention was implemented by less experienced counsellors over a 3-4 week schedule. Outcomes were maintained, with indications of enhanced feasibility and acceptability. High demand was observed across both pilots, leading to more stringent eligibility criteria and a modified sensitisation plan. DISCUSSION Findings have shaped a first-line intervention for common adolescent mental health problems in low-resource settings. A forthcoming randomised controlled trial will test its effectiveness.",2020,"The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists.","['Indian secondary schools', 'common adolescent mental health problems in Indian secondary schools', 'Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools']","['modified counsellor-led problem-solving intervention', 'transdiagnostic, low-intensity, psychological intervention']",[],"[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",[],,0.0559856,"The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Malik', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Krishna', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Bhat', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'Sangath, Goa and New Delhi, India; Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Kallol', 'Initials': 'K', 'LastName': 'Roy', 'Affiliation': 'Shree Krishna Hospital, Gujarat, India.'}, {'ForeName': 'Akankasha', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rooplata', 'Initials': 'R', 'LastName': 'Sahu', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Bhagwant', 'Initials': 'B', 'LastName': 'Chilhate', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Department of Psychology, Loma Linda University, Los Angeles, USA.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology, University of California at Los Angeles, Los Angeles, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath, Goa and New Delhi, India; Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA; Harvard TH Chan School of Public Health, Boston, USA. Electronic address: Vikram_Patel@hms.harvard.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103439'] 1631,11095657,A comparison of on-line hemodiafiltration and high-flux hemodialysis: a prospective clinical study.,"Some of the morbidity associated with chronic hemodialysis is thought to result from retention of large molecular weight solutes that are poorly removed by diffusion in conventional hemodialysis. Hemodiafiltration combines convective and diffusive solute removal in a single therapy. The hypothesis that hemodiafiltration provides better solute removal than high-flux hemodialysis was tested in a prospective, randomized clinical trial. Patients were randomized to either on-line postdilution hemodiafiltration or high-flux hemodialysis. The groups did not differ in body size, treatment time, blood flow rate, or net fluid removal. The filtration volume in hemodiafiltration was 21 +/-1 L. Therapy prescriptions were unchanged for a 12-mo study period. Removal of both small (urea and creatinine) and large (ss(2)-microglobulin and complement factor D) solutes was significantly greater for hemodiafiltration than for high-flux hemodialysis. The increased urea and creatinine removal did not result in lower pretreatment serum concentrations in the hemodiafiltration group. Pretreatment plasma beta(2)-microglobulin concentrations decreased with time (P< 0.001); however, the decrease was similar for both therapies (P = 0.317). Pretreatment plasma complement factor D concentrations also decreased with time (P<0.001), and the decrease was significantly greater with hemodiafiltration than with high-flux hemodialysis (P = 0.010). The conclusion is that on-line hemodiafiltration provides superior solute removal to high-flux hemodialysis over a wide molecular weight range. The improved removal may not result in lower pretreatment plasma concentrations, however, possibly because of limitations in mass transfer rates within the body.",2000,"Pretreatment plasma beta(2)-microglobulin concentrations decreased with time (P< 0.001); however, the decrease was similar for both therapies (P = 0.317).",[],"['hemodiafiltration', 'line postdilution hemodiafiltration or high-flux hemodialysis', 'line hemodiafiltration and high-flux hemodialysis']","['increased urea and creatinine removal', 'Pretreatment plasma beta(2)-microglobulin concentrations', 'filtration volume', 'Removal of both small (urea and creatinine) and large (ss(2)-microglobulin and complement factor D) solutes', 'Pretreatment plasma complement factor D concentrations', 'body size, treatment time, blood flow rate, or net fluid removal']",[],"[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0033457', 'cui_str': 'Properdin Factor D'}, {'cui': 'C0005901', 'cui_str': 'Body Size'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",,0.0156498,"Pretreatment plasma beta(2)-microglobulin concentrations decreased with time (P< 0.001); however, the decrease was similar for both therapies (P = 0.317).","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Ward', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, Kentucky, USA. richard.ward@louisville.edu'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hullin', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Hillebrand', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Samtleben', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,[] 1632,31462117,Efficacy and safety of Tramadol as an analgesic in women undergoing vaginoscopic hysteroscopy: a randomized placebo-controlled trial.,"Pain or discomfort during the hysteroscopy remains a challenge even after the introduction of small calibre instruments and vaginoscopic techniques. Tramadol, a centrally acting analgesic, is one among the medications used to reduce pain; however, the experience with its use in the vaginoscopic technique is limited. This was a randomised double-blind placebo-controlled trial conducted to study the effectiveness of oral Tramadol as an analgesic in 100 women undergoing diagnostic vaginoscopic hysteroscopy. Median pain score assessed by the Visual Analogue Scale was lower in the study group compared to the placebo group during the procedure (7 versus 8; p  < .001) and immediately after the procedure (6 versus 7; p  < .001) Ease of entry, procedure entry time and the adverse effects were similar in both the groups. Administration of oral Tramadol 50 mg, 1 h prior to the procedure may be a safe and effective analgesic in women undergoing diagnostic vaginoscopic hysteroscopy.Impact statement What is already known on this subject? Even with the use of newer hysteroscopes with small calibres and vaginoscopic techniques, pain and discomfort to the patient during negotiation through the cervix remain the main challenge to the surgeon. Among the several medications reported to reduce pain during the procedure, Tramadol a centrally acting drug with dual analgesic action, both by the µ opioid receptor agonist action and by the inhibiting uptake of serotonin and norepinephrine, can be used. However, studies using oral Tramadol during vaginoscopic hysteroscopy are limited. What do the results of this study add? The median pain score assessed by the Visual Analogue Scale was lower in the study group compared to the placebo group during the procedure (7 versus 8; p < .001) and immediately after the procedure (6 versus 7; p < .001). Ease of entry, procedure entry time and the adverse effects were similar in both the groups. What are the implications of these findings for clinical practice and/or further research? This study suggests that administration of oral Tramadol 50 mg, 1 h prior to the procedure, may be used as a safe and effective analgesic in women undergoing diagnostic vaginoscopic hysteroscopy. Future trial with a larger sample size is required to confirm the tolerability of its use, as the incidence of adverse effects was low in the study.",2020,Median pain score assessed by the Visual Analogue Scale was lower in the study group compared to the placebo group during the procedure (7 versus 8; p  < .001) and immediately after the procedure (6 versus 7; p  < .001),"['women undergoing diagnostic vaginoscopic hysteroscopy', '100 women undergoing diagnostic vaginoscopic hysteroscopy', 'women undergoing vaginoscopic hysteroscopy']","['oral Tramadol', 'placebo', 'Tramadol']","['pain', 'median pain score', 'Median pain score', 'Ease of entry, procedure entry time and the adverse effects', 'Visual Analogue Scale', 'Efficacy and safety', 'Pain or discomfort']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",100.0,0.108645,Median pain score assessed by the Visual Analogue Scale was lower in the study group compared to the placebo group during the procedure (7 versus 8; p  < .001) and immediately after the procedure (6 versus 7; p  < .001),"[{'ForeName': 'Shree', 'Initials': 'S', 'LastName': 'Bharathi', 'Affiliation': 'Department of Obstetrics & Gynaecology, Jawaharlal Institute of Post-graduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Dilip Kumar', 'Initials': 'DK', 'LastName': 'Maurya', 'Affiliation': 'Department of Obstetrics & Gynaecology, Jawaharlal Institute of Post-graduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Keepanasseril', 'Affiliation': 'Department of Obstetrics & Gynaecology, Jawaharlal Institute of Post-graduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Kubera', 'Affiliation': 'Department of Obstetrics & Gynaecology, Jawaharlal Institute of Post-graduate Medical Education & Research, Puducherry, India.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1647525'] 1633,31212071,Indwelling Intrauterine Foley Balloon Catheter for Intraoperative and Postoperative Bleeding in Cesarean Scar Pregnancy.,"STUDY OBJECTIVE Cesarean scar pregnancy (CSP) is a rare type of ectopic pregnancy, and a significant concern in the management of this condition is the control and prevention of bleeding. We aimed to determine the efficacy and value of an indwelling, intrauterine Foley balloon catheter in controlling and preventing intraoperative and postoperative bleeding in patients with CSP. DESIGN Retrospective case series. SETTING University-affiliated hospital. PATIENTS Between January 1, 2015 and May 31, 2017, 70 patients presented with CSP. INTERVENTIONS All patients underwent uterine curettage under hysteroscopic guidance and ultrasound monitoring. Patients were then assigned to 2 groups: the study group, with an indwelling Foley balloon catheter placed in the uterine cavity during surgery and retained for 24 to 48 hours, and the control group, without catheter placement. Data were collected to compare the 2 groups in terms of intraoperative and postoperative complications, surgical time, and status of menstruation resumption. MEASUREMENTS AND MAIN RESULTS The average daily volume of postoperative blood loss during the first 3 postoperative days in the study group was 23.1 mL compared with 31.5 mL observed in the control group (p = .041). Moreover, the study group had significantly shorter average duration of bleeding (p = .027) and fewer menstruation abnormalities than the control group. Uterine ultrasonography performed after resumption of menstruation showed that none of the enrolled patients had any intrauterine abnormalities. CONCLUSIONS The use of an indwelling, intrauterine Foley balloon catheter has positive results in the management of CSP.",2020,"Moreover, the study group had significantly shorter average duration of bleeding (p = .027) and fewer menstruation abnormalities than the control group.","['Between January 1, 2015 and May 31, 2017, 70 patients presented with CSP', 'Cesarean scar pregnancy (CSP', 'patients with CSP', 'A university-affiliated hospital', 'Cesarean Scar Pregnancy']","['Uterine ultrasonography', 'uterine curettage under hysteroscopic guidance and ultrasound monitoring', 'indwelling Foley balloon catheter placed', 'intrauterine Foley balloon catheter', 'control group without catheter placement', 'Intrauterine Foley Balloon Catheter']","['average daily volume of postoperative blood loss', 'cesarean scar pregnancy', 'intraoperative and postoperative complications, surgical time, and status of menstruation resumption', 'average duration of bleeding', 'menstruation abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.0493816,"Moreover, the study group had significantly shorter average duration of bleeding (p = .027) and fewer menstruation abnormalities than the control group.","[{'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Lu', 'Affiliation': 'Department of Gynecology and Obstetrics, The Affiliated Shengjing Hospital, China Medical University, Shenyang, China (all authors).. Electronic address: luyanming555@163.com.'}, {'ForeName': 'Ya-Ru', 'Initials': 'YR', 'LastName': 'Guo', 'Affiliation': 'Department of Gynecology and Obstetrics, The Affiliated Shengjing Hospital, China Medical University, Shenyang, China (all authors).'}, {'ForeName': 'Meng-Ya', 'Initials': 'MY', 'LastName': 'Zhou', 'Affiliation': 'Department of Gynecology and Obstetrics, The Affiliated Shengjing Hospital, China Medical University, Shenyang, China (all authors).'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology and Obstetrics, The Affiliated Shengjing Hospital, China Medical University, Shenyang, China (all authors).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.02.024'] 1634,31125720,Comparison of Carbon Dioxide Absorption Rates in Gynecologic Laparoscopy with a Valveless versus Standard Insufflation System: Randomized Controlled Trial.,"STUDY OBJECTIVE The primary objective was to compare carbon dioxide (CO 2 ) absorption rates in patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg. Secondary objectives were assessment of surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO 2 (etCO 2 ), and patients' report of postoperative shoulder pain. DESIGN A randomized controlled trial using an equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation/IAP 10 mm Hg, and valveless insufflation/IAP 15 mm Hg. SETTING Single tertiary care academic institution. PATIENTS Women ≥ 18 years old undergoing nonemergent conventional or robotic gynecologic laparoscopic surgery. INTERVENTIONS A standard or valveless insufflation system at IAPs of 10 or 15 mm Hg. MEASUREMENTS AND MAIN RESULTS One hundred thirty-two patients were enrolled and randomized with 33 patients per group. There were 84 robotic cases and 47 conventional laparoscopic cases. CO 2 absorption rates (mL/kg*min) did not differ across groups with mean rates of 4.00 ± 1.3 in the valveless insufflation groups and 4.00 ± 1.1 in the standard insufflation groups. The surgeons' rating of overall visualization of the operative field on a 10-point Likert scale favored the valveless insufflation system (median visualization, 9.0 ± 2.0 cm and 9.5 ± 1.8 cm at 10 and 15 mm Hg, respectively) over standard insufflation (7.0 ± 3.0 cm and 7.0 ± 2.0 cm at 10 and 15 mm Hg, respectively; p <.001). The anesthesiologists' ability to maintain adequate etCO 2 was similar across groups (p = .417). Postoperative shoulder pain scores were low overall with no significant difference across groups (p >.05). CONCLUSION CO 2 absorption rates, anesthesiologists' ability to maintain adequate etCO 2 , and postoperative shoulder pain did not differ based on insufflation system type or IAP. Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.",2020,Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.,"['Gynecologic Laparoscopy with a Valveless versus Standard Insufflation System', 'patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg', 'One hundred thirty-two patients were enrolled and randomized with 33 patients per group', 'Women ≥ 18 years old undergoing', 'Single tertiary care academic institution']","['nonemergent conventional or robotic gynecologic laparoscopic surgery', 'equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation']","[""Surgeons' rating of visualization of the operative field"", 'Postoperative shoulder pain scores', 'carbon dioxide (CO 2 ) absorption rates', 'Carbon Dioxide Absorption Rates', 'postoperative shoulder pain', 'CO 2 absorption rates', ""surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO 2 (etCO 2 ), and patients' report of postoperative shoulder pain""]","[{'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",132.0,0.215547,Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.,"[{'ForeName': 'Obianuju S', 'Initials': 'OS', 'LastName': 'Madueke-Laveaux', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York. Electronic address: somadueke@gmail.com.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Advincula', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Grimes', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Walters', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Khara', 'Initials': 'K', 'LastName': 'Simpson', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Truong', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Landau', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Ryntz', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.05.005'] 1635,31424957,"The Evaluation of TUNEL, PCNA and SOX2 Expressions in Lens Epithelial Cells of Cataract Patients with Pseudoexfoliation Syndrome.","Purpose : This study aims to determine the expression patterns of terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling (TUNEL), proliferating cell nuclear antigen (PCNA) and SOX2 in lens epithelial cells (LEC) of cataract patients with pseudoexfoliation syndrome (PEX), and to determine the effect of apoptosis, proliferative activity and stem/progenitor cells on cataract formation in patients with PEX. This is a prospective, randomized clinical trial. Materials and Methods : Setting: institutional. 50 eyes of 50 patients were included. Anterior capsule samples were obtained during phacoemulsification surgery. The specimens of LEC were also examined using the TUNEL, PCNA and SOX2 immunohistochemical staining method. To detect the number of immunopositive cells, the total number of cells in a 3 mm 2 area was counted using a microscope under x20 magnification and the percentage of cells stained positive was determined. Results : In Group 1, increased expression was observed with TUNEL, while decreased expression was detected with PCNA ( p = .008, p = .015). The average percentage of TUNEL immunopositive cells was significantly higher in Group 1 than in Group 2, but there was no statistically meaningful SOX2 expression in Group 1 and Group 2 ( P = .44). Apoptosis rates were 61.75 ± 14.5% and 36.91 ± 14.6% in Groups 1 and 2, respectively. Proliferation rates were 40.96 ± 16.8% and 65.45 ± 16.9% in Groups 1 and 2, respectively. Conclusion : We found increased apoptosis and decreased proliferation of LECs in cataract patients with PEX. We suspected that this could be related to oxidative stress.",2020,"The average percentage of TUNEL immunopositive cells was significantly higher in Group 1 than in Group 2, but there was no statistically meaningful SOX2 expression in Group 1 and Group 2 ( P = .44).","['cataract patients with PEX', '50 eyes of 50 patients were included', 'patients with PEX', 'Cataract Patients with Pseudoexfoliation Syndrome', 'cataract patients with pseudoexfoliation syndrome (PEX']","['Materials and Methods ', 'terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling (TUNEL), proliferating cell nuclear antigen (PCNA) and SOX2']","['Proliferation rates', 'expression', 'average percentage of TUNEL immunopositive cells', 'proliferation of LECs', 'Apoptosis rates', 'meaningful SOX2 expression', 'number of immunopositive cells, the total number of cells', 'increased expression']","[{'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206368', 'cui_str': 'Glaucoma Capsulare'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0687124', 'cui_str': 'Terminal deoxynucleotidyl transferase stain'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0072108', 'cui_str': 'PCNA'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0600528', 'cui_str': 'TUNEL'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",50.0,0.0445749,"The average percentage of TUNEL immunopositive cells was significantly higher in Group 1 than in Group 2, but there was no statistically meaningful SOX2 expression in Group 1 and Group 2 ( P = .44).","[{'ForeName': 'Gulay', 'Initials': 'G', 'LastName': 'Turan', 'Affiliation': 'Faculty of Medicine, Department of Pathology, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Meydan', 'Initials': 'M', 'LastName': 'Turan', 'Affiliation': 'Department of Ophthalmology, Balikesir Ataturk City Hospital, Balikesir, Turkey.'}]",Current eye research,['10.1080/02713683.2019.1657463'] 1636,31416768,"Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial.","BACKGROUND Infants are a key target population for new tuberculosis vaccines. We assessed the safety and immunogenicity of the live-attenuated Mycobacterium tuberculosis vaccine candidate MTBVAC in adults and infants in a region where transmission of tuberculosis is very high. METHODS We did a randomised, double-blind, BCG-controlled, dose-escalation trial at the South African Tuberculosis Vaccine Initiative site near Cape Town, South Africa. Healthy adult community volunteers who were aged 18-50 years, had received BCG vaccination as infants, were HIV negative, had negative interferon-γ release assay (IGRA) results, and had no personal history of tuberculosis or current household contact with someone with tuberculosis were enrolled in a safety cohort. Infants born to HIV-negative women with no personal history of tuberculosis or current household contact with a person with tuberculosis and who were 96 h old or younger, generally healthy, and had not yet received routine BCG vaccination were enrolled in a separate infant cohort. Eligible adults were randomly assigned (1:1) to receive either BCG Vaccine SSI (5 × 10 5 colony forming units [CFU] of Danish strain 1331 in 0·1 mL diluent) or MTBVAC (5 × 10 5 CFU in 0·1 mL) intradermally in the deltoid region of the arm. After favourable review of 28-day reactogenicity and safety data in the adult cohort, infants were randomly assigned (1:3) to receive either BCG Vaccine SSI (2·5 × 10 5 CFU in 0·05 mL diluent) or MTBVAC in three sequential cohorts of increasing MTBVAC dose (2·5 × 10 3 CFU, 2·5 × 10 4 CFU, and 2·5 × 10 5 CFU in 0·05 mL) intradermally in the deltoid region of the arm. QuantiFERON-TB Gold In-Tube IGRA was done on days 180 and 360. For both randomisations, a pre-prepared block randomisation schedule was used. Participants (and their parents or guardians in the case of infant participants), investigators, and other clinical and laboratory staff were masked to intervention allocation. The primary outcomes, which were all measured in the infant cohort, were solicited and unsolicited local adverse events and serious adverse events until day 360; non-serious systemic adverse events until day 28 and vaccine-specific CD4 and CD8 T-cell responses on days 7, 28, 70, 180, and 360. Secondary outcomes measured in adults were local injection-site and systemic reactions and haematology and biochemistry at study day 7 and 28. Safety analyses and immunogenicity analyses were done in all participants who received a dose of vaccine. This trial is registered with ClinicalTrials.gov, number NCT02729571. FINDINGS Between Sept 29, 2015, and Nov 16, 2015, 62 adults were screened and 18 were enrolled and randomly assigned, nine each to the BCG and MTBVAC groups. Between Feb 12, 2016, and Sept 21, 2016, 36 infants were randomly assigned-eight to the BCG group, nine to the 2·5 × 10 3 CFU MTBVAC group, nine to the 2·5 × 10 4 CFU group, and ten to the 2·5 × 10 5 CFU group. Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 10 5 CFU MTBVAC group, with no evidence of local or regional injection-site complications. Systemic adverse events were evenly distributed across BCG and MTBVAC dose groups, and were mostly mild in severity. Eight serious adverse events were reported in seven vaccine recipients (one adult MTBVAC recipient, one infant BCG recipient, one infant in the 2·5 × 10 3 CFU MTBVAC group, two in the 2·5 × 10 4 CFU MTBVAC group, and two in the 2·5 × 10 5 CFU MTBVAC group), including one infant in the 2·5 × 10 3 CFU MTBVAC group treated for unconfirmed tuberculosis and one in the 2·5 × 10 5 CFU MTBVAC group treated for unlikely tuberculosis. One infant died as a result of possible viral pneumonia. Vaccination with all MTBVAC doses induced durable antigen-specific T-helper-1 cytokine-expressing CD4 cell responses in infants that peaked 70 days after vaccination and were detectable 360 days after vaccination. For the highest MTBVAC dose (ie, 2·5 × 10 5 CFU), these responses exceeded responses induced by an equivalent dose of the BCG vaccine up to 360 days after vaccination. Dose-related IGRA conversion was noted in three (38%) of eight infants in the 2·5 × 10 3 CFU MTBVAC group, six (75%) of eight in the 2·5 × 10 4 CFU MTBVAC group, and seven (78%) of nine in the 2·5 × 10 5 CFU MTBVAC group at day 180, compared with none of seven infants in the BCG group. By day 360, IGRA reversion had occurred in all three infants (100%) in the 2·5 × 10 3 CFU MTBVAC group, four (67%) of the six in the 2·5 × 10 4 CFU MTBVAC group, and three (43%) of the seven in the 2·5 × 10 5 CFU MTBVAC group. INTERPRETATION MTBVAC had acceptable reactogenicity, and induced a durable CD4 cell response in infants. The evidence of immunogenicity supports progression of MTBVAC into larger safety and efficacy trials, but also confounds interpretation of tests for M tuberculosis infection, highlighting the need for stringent endpoint definition. FUNDING Norwegian Agency for Development Cooperation, TuBerculosis Vaccine Initiative, UK Department for International Development, and Biofabri.",2019,"Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 10 5 CFU MTBVAC group, with no evidence of local or regional injection-site complications.","['Between Sept 29, 2015, and Nov 16, 2015, 62 adults were screened and 18', 'Infants born to HIV-negative women with no personal history of tuberculosis or current household contact with a person with tuberculosis and who were 96 h old or younger, generally healthy, and had not yet received routine BCG vaccination were enrolled in a separate infant cohort', 'Participants (and their parents or guardians in the case of infant participants), investigators, and other clinical and laboratory staff were masked to intervention allocation', 'Between Feb 12, 2016, and Sept 21, 2016, 36 infants', 'adults and infants in a region where transmission of tuberculosis is very high', 'adult cohort, infants', 'adults and neonates', 'Eligible adults', 'Healthy adult community volunteers who were aged 18-50 years, had received BCG vaccination as infants, were HIV negative, had negative interferon-γ release assay (IGRA) results, and had no personal history of tuberculosis or current household contact with someone with tuberculosis were enrolled in a safety cohort', 'South African Tuberculosis Vaccine Initiative site near Cape Town, South Africa']","['Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG', 'vaccine', 'QuantiFERON-TB Gold', 'BCG', 'BCG vaccine', 'live-attenuated Mycobacterium tuberculosis vaccine candidate MTBVAC', 'BCG Vaccine SSI (2·5\u2008×\u200810 5 CFU in 0·05 mL diluent) or MTBVAC', 'BCG Vaccine SSI (5\u2008×\u200810 5 colony forming units [CFU] of Danish strain 1331 in 0·1 mL diluent) or MTBVAC ']","['durable CD4 cell response', 'local injection-site and systemic reactions and haematology and biochemistry', 'IGRA conversion', 'solicited and unsolicited local adverse events and serious adverse events until day 360; non-serious systemic adverse events until day 28 and vaccine-specific CD4 and CD8 T-cell responses', 'IGRA reversion', 'safety and immunogenicity', 'Systemic adverse events', 'durable antigen-specific T-helper-1 cytokine-expressing CD4 cell responses', 'Mild injection-site reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0424945', 'cui_str': 'Social / personal history observable'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041305', 'cui_str': 'Tuberculosis Vaccines'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1274119', 'cui_str': 'Haematology (specialty)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}]",62.0,0.353474,"Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 10 5 CFU MTBVAC group, with no evidence of local or regional injection-site complications.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tameris', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mearns', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Penn-Nicholson', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Gregg', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bilek', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Mabwe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hennie', 'Initials': 'H', 'LastName': 'Geldenhuys', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Shenje', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Angelique Kany Kany', 'Initials': 'AKK', 'LastName': 'Luabeya', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Murillo', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Doce', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Nacho', 'Initials': 'N', 'LastName': 'Aguilo', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Dessislava', 'Initials': 'D', 'LastName': 'Marinova', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Puentes', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Rodríguez', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Gonzalo-Asensio', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Fritzell', 'Affiliation': 'Tuberculosis Vaccine Initiative, Lelystad, Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Thole', 'Affiliation': 'Tuberculosis Vaccine Initiative, Lelystad, Netherlands.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain; Servicio de Microbiología, Hospital Miguel Servet, ISS Aragon, Zaragoza, Spain.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Scriba', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hatherill', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. Electronic address: mark.hatherill@uct.ac.za.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30251-6'] 1637,30918843,Substitution of red meat with soybean but not non- soy legumes improves inflammation in patients with type 2 diabetes; a randomized clinical trial.,"Background and aims Several studies have documented that consumption of legumes including soybean is inversely associated with systemic inflammation and oxidative stress. This study was done to assess the effects of soy beans or non-soy legumes consumption on C-reactive protein (CRP) and malondialdehyde (MDA) among Patients with Type 2 Diabetes (T2D). Methods 75 persons with T2D participated in this randomized controlled clinical trial. Participants were randomized to one of the following 3 groups for 8 weeks: soy bean group (taking a cup of cooked soy beans three days a week), legumes group (taking a cup of cooked non-soy legumes three days a week) and control group (taking two servings of red meat three days a week). Anthropometric indices, dietary intakes, and serum MDA and CRP were measured at baseline and after intervention. Results A Significant decrease was observed in serum CRP of soy bean group ( P  = 0.01) which was significantly more than the controls ( p  = 0.001), while no significant changes of CRP was observed in legume group. Serum MDA changed significantly in none of the 3 groups. Conclusions In conclusion, we found that substitution of red meat with soybean but not non- soy legumes may reduce inflammatory factors with no effects on oxidative stress in diabetic patients.",2018,"A Significant decrease was observed in serum CRP of soy bean group ( P  = 0.01) which was significantly more than the controls ( p  = 0.001), while no significant changes of CRP was observed in legume group.","['75 persons with T2D participated', 'Patients with Type 2 Diabetes (T2D', 'patients with type 2 diabetes', 'diabetic patients']","['red meat with soybean but not non- soy legumes', 'soy bean group (taking a cup of cooked soy beans three days a week), legumes group (taking a cup of cooked non-soy legumes three days a week) and control group (taking two servings of red meat three days a week', 'soy beans or non-soy legumes consumption']","['oxidative stress', 'serum CRP', 'Anthropometric indices, dietary intakes, and serum MDA and CRP', 'CRP', 'Serum MDA', 'C-reactive protein (CRP) and malondialdehyde (MDA']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}, {'cui': 'C0453184', 'cui_str': 'Legumes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}]",75.0,0.0708769,"A Significant decrease was observed in serum CRP of soy bean group ( P  = 0.01) which was significantly more than the controls ( p  = 0.001), while no significant changes of CRP was observed in legume group.","[{'ForeName': 'Zeynab', 'Initials': 'Z', 'LastName': 'Hematdar', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Ghasemifard', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Phishdad', 'Affiliation': '2Department of Internal Medicine, Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Faghih', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-018-0346-6'] 1638,31478939,Rigid Mini-Thoracoscopy Versus Semirigid Thoracoscopy in Undiagnosed Exudative Pleural Effusion: The MINT Randomized Controlled Trial.,"BACKGROUND There is debate regarding the ideal instrument for medical thoracoscopy. The authors compared rigid mini-thoracoscopy with semirigid thoracoscopy for thoracoscopic pleural biopsy. METHODS Consecutive subjects with undiagnosed exudative pleural effusion were randomized (1:1 ratio) to mini-thoracoscopy or semirigid thoracoscopy groups. The primary objective was a comparison of the diagnostic yield of pleural biopsy. Key secondary outcomes were the comparison of sedative/analgesic dose, operator-rated and patient-rated pain on visual analog scale (VAS), operator-rated overall procedural satisfaction (VAS), pleural biopsy size, and complications between the groups. RESULTS Of the 88 screened subjects, 73 were randomized: 36 to mini-thoracoscopy and 37 to semirigid thoracoscopy. Diagnostic yield of pleural biopsy in the mini-thoracoscopy (69.4%) and semirigid thoracoscopy groups (81.1%) was similar on intention-to-treat analysis (P=0.25). Although the operator-rated overall procedure satisfaction scores were similar between groups (P=0.87), operator-rated pain [VAS (mean±SD), 43.5±16.7 vs. 31.7±15.8; P<0.001] and patient-rated pain (VAS, 41.9±17.3 vs. 32.1±16.5; P=0.02) scores were greater in the mini-thoracoscopy group. Mean dose of fentanyl and midazolam received was similar between the 2 groups (P=0.28 and 0.68, respectively). Biopsy size was larger in the mini-thoracoscopy group (16.1±4.5 vs. 8.3±2.9 mm; P<0.001). Three minor complications occurred in the mini-thoracoscopy group and 6 in the semirigid thoracoscopy group (P=0.11). There were no serious adverse events or procedure-related mortality. CONCLUSION Diagnostic yield of rigid mini-thoracoscopy is not superior to semirigid thoracoscopy. Use of semirigid thoracoscope may provide greater patient comfort.",2020,"Mean dose of fentanyl and midazolam received was similar between the 2 groups (P=0.28 and 0.68, respectively).","['88 screened subjects', 'Undiagnosed Exudative Pleural Effusion', 'Consecutive subjects with undiagnosed exudative pleural effusion']","['rigid mini-thoracoscopy with semirigid thoracoscopy', 'rigid mini-thoracoscopy', 'semirigid thoracoscope', 'midazolam', 'mini-thoracoscopy or semirigid thoracoscopy groups', 'mini-thoracoscopy and 37 to semirigid thoracoscopy', 'Rigid Mini-Thoracoscopy Versus Semirigid Thoracoscopy', 'semirigid thoracoscopy']","['comparison of sedative/analgesic dose, operator-rated and patient-rated pain on visual analog scale (VAS), operator-rated overall procedural satisfaction (VAS), pleural biopsy size, and complications between the groups', 'operator-rated pain [VAS (mean±SD', 'serious adverse events or procedure-related mortality', 'procedure satisfaction scores', 'diagnostic yield of pleural biopsy', 'Biopsy size', 'patient-rated pain', 'minor complications', 'Diagnostic yield of pleural biopsy']","[{'cui': 'C3887491', 'cui_str': 'Exudative pleural effusion (disorder)'}]","[{'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0183932', 'cui_str': 'Pleuroscopes'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0176531', 'cui_str': 'Biopsy of pleura (procedure)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]",73.0,0.16166,"Mean dose of fentanyl and midazolam received was similar between the 2 groups (P=0.28 and 0.68, respectively).","[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}, {'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Pathology.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Arava', 'Affiliation': 'Pathology.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Hadda', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}, {'ForeName': 'Prabhat', 'Initials': 'P', 'LastName': 'Malik', 'Affiliation': 'Medical Oncology.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gopi C', 'Initials': 'GC', 'LastName': 'Khilnani', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Madan', 'Affiliation': 'Departments of Pulmonary, Critical Care and Sleep Medicine.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000620'] 1639,12958610,Increased plasma levels of plasminogen activator inhibitor-1 and soluble vascular cell adhesion molecule after triacylglycerol infusion in man.,"Increased plasma plasminogen activator inhibitor-1 (PAI-1) has been implicated in the development of vascular disease. In type 2 diabetes mellitus high PAI-1 levels are associated with increased plasma concentrations of free fatty acids (FFA) and triacylglycerol indicating an association or a causal relationship. To answer that question, the effect of FFA/triacylglycerol on plasma PAI-1 was examined. Ten healthy male volunteers were studied for 6 h during infusion of triacylglycerol [1.5 ml/min]/heparin [0.2 IU/(kg.min)] (LIP; n=10), saline only (SAL; n=10), and saline/heparin (HEP; n=5). Plasma insulin concentrations were kept constant at approximately 35 pmol/l by intravenous somatostatin-insulin infusions and there was no significant change in plasma glucose levels during any of the study protocols. LIP increased plasma triacylglycerol and FFA approximately 3- (p < 0.001) and approximately 8- (p < 0.000001) fold, respectively, within 90 min. Baseline plasma PAI-1 measured by a bio-immunoassay was similar in HEP (11.4 +/- 2.8 ng/ml), SAL (16.6 +/- 3.6 ng/ml), and LIP studies (15.2 +/- 3.4 ng/ml). Since studies were initiated in the morning, PAI-1 decreased (p < 0.025) over time following its normal diurnal variation to 6.4 +/- 2.0 ng/ml and 4.0 +/- 2.4 ng/ml at 360 min in SAL and HEP, respectively. During LIP, however, PAI-1 increased to approximately 2.6 fold higher levels than during SAL at 360 min (16.4 +/- 4.0 ng/ml, p < 0.01). While tissue plasminogen activator (tPA) and adipsin, an adipocyte derived protease, were unaffected by LIP, changes in soluble vascular cell adhesion molecule-1 (sVCAM-1) were significantly correlated (p = 0.02) with those seen for PAI-1. This suggests that hyperlipidemia independent of insulin and plasma glucose levels stimulates vascular tissue and in turn might induce an increase in plasma PAI-1. PAI-1 then could contribute to the development of atherothrombotic vascular disease.",2003,Increased plasma plasminogen activator inhibitor-1,"['man', 'Ten healthy male volunteers']","['SAL', 'FFA/triacylglycerol', 'saline/heparin', 'triacylglycerol [1.5 ml/min]/heparin']","['soluble vascular cell adhesion molecule-1 (sVCAM-1', 'Baseline plasma PAI-1', 'plasma levels of plasminogen activator inhibitor-1 and soluble vascular cell adhesion molecule', 'plasma plasminogen activator inhibitor-1', 'plasma triacylglycerol and FFA', 'Plasma insulin concentrations', 'plasma glucose levels', 'While tissue plasminogen activator (tPA) and adipsin']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0033457', 'cui_str': 'Properdin Factor D'}]",10.0,0.277387,Increased plasma plasminogen activator inhibitor-1,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krebs', 'Affiliation': 'Department of Vascular Biology and Thrombosis Research, University of Vienna, Schwarzspanierstrasse 17, A-1090 Vienna, Austria.'}, {'ForeName': 'Margarethe', 'Initials': 'M', 'LastName': 'Geiger', 'Affiliation': ''}, {'ForeName': 'Kaija', 'Initials': 'K', 'LastName': 'Polak', 'Affiliation': ''}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Vales', 'Affiliation': ''}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Schmetterer', 'Affiliation': ''}, {'ForeName': 'Oswald F', 'Initials': 'OF', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Waldhäusl', 'Affiliation': ''}, {'ForeName': 'Bernd R', 'Initials': 'BR', 'LastName': 'Binder', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': ''}]",Thrombosis and haemostasis,[] 1640,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041'] 1641,32440977,Persistence of Inflammation After Uncomplicated Cataract Surgery: A 6-Month Laser Flare Photometry Analysis.,"PURPOSE To evaluate, by laser photometry, the persistency of anterior chamber flare after uneventful phacoemulsification in asymptomatic patients with no signs of inflammation on slit lamp examination. METHOD Seventy-five patients previously enrolled in a randomized clinical trial that evaluated inflammation after uneventful phacoemulsification in eyes treated with dexamethasone 0.1% ophthalmic suspension (group 1) or bromfenac 0.09% ophthalmic solution (group 2) for 2 weeks. Anterior chamber inflammation was investigated by laser flare photometry. At 30 days after surgery, laser flare showed persistently elevated values. For this reason, patients were further analyzed at 3 and 6 months. Additionally, optical coherence tomography was used to measure the central macular thickness (CMT) and to assess for postoperative pseudophakic macular edema. RESULTS When compared to preoperative values, laser flare photometry demonstrated persistent ocular inflammation at postoperative days 90 and 180 in group 1, but not in group 2. Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001). The increase in mean CMT at days 90 and 180 with respect to baseline was statistically significant in group 1 but not in group 2, in which it decreased to levels similar to preoperative value. Group 1 showed a higher increase in mean CMT compared to group 2 throughout all the follow-up (p < 0.001). The proportion of patients that developed pseudophakic cystoid macular edema (CME) was 14% (n = 5) and 0% (n = 0) in group 1 and group 2, respectively (p = 0.02). The bivariate analysis demonstrated a positive correlation between laser flare and CMT values in group 1 but not in group 2. CONCLUSION Anterior chamber inflammation persists for more than 30 days in a significant proportion of patients after uncomplicated cataract surgery and may be responsible for late onset of cystoid macular edema cases. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03317847.",2020,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"['asymptomatic patients with no signs of inflammation on slit lamp examination', 'Seventy-five patients previously enrolled']","['dexamethasone 0.1% ophthalmic suspension (group\xa01) or bromfenac 0.09% ophthalmic solution', 'optical coherence tomography']","['Anterior chamber inflammation', 'central macular thickness (CMT', 'pseudophakic cystoid macular edema (CME', 'Persistence of Inflammation', 'ocular inflammation', 'Laser flare values', 'mean CMT']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1562105', 'cui_str': 'Bromfenac (as bromfenac sodium) 900 microgram/mL eye solution'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",75.0,0.0199933,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Maria', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Coassin', 'Affiliation': 'Ophthalmology, University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mastrofilippo', 'Affiliation': 'Clinical Trials and Statistics Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cimino', 'Affiliation': 'Ocular Immunology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Iannetta', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. luifonta@gmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01383-1'] 1642,31411950,Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy in EGFR -Mutated Lung Cancer.,"PURPOSE Standard first-line therapy for EGFR -mutant advanced non-small-cell lung cancer (NSCLC) is an epidermal growth factor receptor (EGFR)-directed oral tyrosine kinase inhibitor. Adding pemetrexed and carboplatin chemotherapy to an oral tyrosine kinase inhibitor may improve outcomes. PATIENTS AND METHODS This was a phase III randomized trial in patients with advanced NSCLC harboring an EGFR -sensitizing mutation and a performance status of 0 to 2 who were planned to receive first-line palliative therapy. Random assignment was 1:1 to gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m 2 and carboplatin area under curve 5 intravenously every 3 weeks for four cycles, followed by maintenance pemetrexed (gefitinib plus chemotherapy [Gef+C]). The primary end point was progression-free survival (PFS); secondary end points included overall survival (OS), response rate, and toxicity. RESULTS Between 2016 and 2018, 350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174). Twenty-one percent of patients had a performance status of 2, and 18% of patients had brain metastases. Median follow-up time was 17 months (range, 7 to 30 months). Radiologic response rates were 75% and 63% in the Gef+C and Gef arms, respectively ( P = .01). Estimated median PFS was significantly longer with Gef+C than Gef (16 months [95% CI, 13.5 to 18.5 months] v 8 months [95% CI, 7.0 to 9.0 months], respectively; hazard ratio for disease progression or death, 0.51 [95% CI, 0.39 to 0.66]; P < .001). Estimated median OS was significantly longer with Gef+C than Gef (not reached v 17 months [95% CI, 13.5 to 20.5 months]; hazard ratio for death, 0.45 [95% CI, 0.31 to 0.65]; P < .001). Clinically relevant grade 3 or greater toxicities occurred in 51% and 25% of patients in the Gef+C and Gef arms, respectively ( P < .001). CONCLUSION Adding pemetrexed and carboplatin chemotherapy to gefitinib significantly prolonged PFS and OS but increased toxicity in patients with NSCLC.",2020,Estimated median OS was significantly longer with Gef+C than Gef (not reached v 17 months,"['350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174', 'EGFR -mutant advanced non-small-cell lung cancer (NSCLC', 'EGFR -Mutated Lung Cancer', 'Between 2016 and 2018', 'patients with advanced NSCLC harboring an EGFR -sensitizing mutation and a performance status of 0 to 2 who were', 'patients with NSCLC']","['planned to receive first-line palliative therapy', 'pemetrexed (gefitinib plus chemotherapy [Gef+C', 'Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy', 'Gef+C', 'gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m 2 and carboplatin', 'pemetrexed and carboplatin chemotherapy']","['Estimated median PFS', 'hazard ratio for death', 'brain metastases', 'overall survival (OS), response rate, and toxicity', 'Radiologic response rates', 'progression-free survival (PFS', 'hazard ratio for disease progression or death', 'Clinically relevant grade 3 or greater toxicities', 'Estimated median OS', 'toxicity']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0030231', 'cui_str': 'Palliative Supportive Care'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4074670', 'cui_str': 'pemetrexed 500 MG'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",350.0,0.130639,Estimated median OS was significantly longer with Gef+C than Gef (not reached v 17 months,"[{'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vijay Maruti', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Chougule', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Janu', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nilendu', 'Initials': 'N', 'LastName': 'Purandare', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'More', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Goud', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nandkumar', 'Initials': 'N', 'LastName': 'Kadam', 'Affiliation': 'Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Daware', 'Affiliation': 'Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Srushti', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vaishakhi', 'Initials': 'V', 'LastName': 'Trivedi', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vichitra', 'Initials': 'V', 'LastName': 'Behel', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dutt', 'Affiliation': 'Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Shripad Dinanath', 'Initials': 'SD', 'LastName': 'Banavali', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01154'] 1643,31443919,"Initial and Sustained Response Effects of 3 Vagal Maneuvers in Supraventricular Tachycardia: A Randomized, Clinical Trial.","BACKGROUND For acute termination of supraventricular tachycardia (SVT), vagal maneuvers, including the standard Valsalva maneuver (sVM), modified Valsalva (mVM) maneuver, and carotid sinus massage (CSM), are first-line interventions. There is no criterion standard technique. OBJECTIVE This prospective, randomized study was aimed at analyzing the success rates of these 3 vagal maneuvers as measured by sustaining sinus rhythm at the fifth minute and SVT termination. METHODS We conducted this prospective, randomized controlled study in an emergency department (ED). We enrolled all the patients who were admitted to the ED and diagnosed with SVT. We randomly assigned them to 3 groups receiving sVM, mVM, and CSM and recorded the patients' responses to the vagal maneuvers and SVT recurrence after vagal maneuvers. RESULTS The study was completed with 98 patients. A total of 25 (25.5%) instances of SVT were initially treated successfully with vagal maneuvers. The success rate was 43.7% (14/32 cases) from mVM, 24.2% (8/33) for sVM, and 9.1 % (3/33) for CSM (p < 0.05). At the end of the fifth minute, only 12.2% (12/98) of all patients had sinus rhythm. Sinus rhythm persisted in 28.1% (9/32) of patients in the mVM group, 6.1% (2/33) of patients in the sVM group, and 3% (1/33) in the CSM group at the fifth minute (p < 0.05). CONCLUSION mVM is superior to the CSM maneuver in terminating SVT and maintaining rhythm. We conclude that it is beneficial to use mVM, which is more effective and lacks side effects.",2019,"The success rate was 43.7% (14/32 cases) from mVM, 24.2% (8/33) for sVM, and 9.1 % (3/33) for CSM (p < 0.05).","['98 patients', 'patients who were admitted to the ED and diagnosed with SVT', 'Supraventricular Tachycardia']","['standard Valsalva maneuver (sVM), modified Valsalva (mVM) maneuver, and carotid sinus massage (CSM', '3 Vagal Maneuvers', 'sVM, mVM, and CSM']","['sinus rhythm', 'Sinus rhythm', 'success rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042293', 'cui_str': 'Valsalva Maneuver'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1112431', 'cui_str': 'Carotid sinus massage'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}]","[{'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}]",,0.026862,"The success rate was 43.7% (14/32 cases) from mVM, 24.2% (8/33) for sVM, and 9.1 % (3/33) for CSM (p < 0.05).","[{'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Ceylan', 'Affiliation': 'Department of Emergency Medicine, Sanlıurfa Research and Training Hospital, Sanlıurfa, Turkey.'}, {'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Ozpolat', 'Affiliation': 'Department of Emergency Medicine, Marmara University Pendik Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Onur', 'Affiliation': 'Department of Emergency Medicine, Sanlıurfa Research and Training Hospital, Sanlıurfa, Turkey.'}, {'ForeName': 'Haldun', 'Initials': 'H', 'LastName': 'Akoglu', 'Affiliation': 'Department of Emergency Medicine, Marmara University Pendik Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Denizbasi', 'Affiliation': 'Department of Emergency Medicine, Marmara University Pendik Research and Training Hospital, Istanbul, Turkey.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.06.008'] 1644,31298466,Effect of Synbiotic Supplementation in a Very-Low-Calorie Ketogenic Diet on Weight Loss Achievement and Gut Microbiota: A Randomized Controlled Pilot Study.,"SCOPE Little is known about the changes that a very-low-calorie ketogenic diet (VLCKD) produces in gut microbiota or the effect of synbiotics during the diet. The aim of this study is to evaluate changes in gut microbiota produced by a VLCKD and synbiotic supplementation. METHODS AND RESULTS A randomized, single-blind, parallel-design trial is conducted in 33 obese patients who follow a weight-loss program (PnK-Method) that include a VLCKD followed by a low-calorie diet (LCD). Subjects are randomly allocated to three groups: one supplemented with synbiotics, a second group supplemented with a placebo during the VLCKD and synbiotics during the LCD phase, and a control group given a placebo. Although symbiotic administration do not produce an effect on microbial diversity, an increase in short-chain fatty aciding producing bacteria and anti-inflammatory mediator signals such as Odoribacter and Lachnospira is shown. The administration of Bifidobacterium animalis subsp. lactis and prebiotics fiber during the LCD is significantly associated with the percentage of weight loss and change in glucose, C-reactive protein and lipopolysaccharide-binding protein. CONCLUSIONS VLCKD produces important changes in gut microbiota. The administration of synbiotics during VLCKD can improve weight loss through the amelioration of inflammation, which may be mediated by the gut microbiota.",2019,"Although symbiotic administration do not produce an effect on microbial diversity, an increase in short-chain fatty aciding producing bacteria and anti-inflammatory mediator signals such as Odoribacter and Lachnospira is shown.",['33 obese patients who follow a weight-loss program (PnK-Method) that include a VLCKD followed by a low-calorie diet (LCD'],"['VLCKD and synbiotic supplementation', 'placebo', 'Synbiotic Supplementation', 'VLCKD']","['Weight Loss Achievement and Gut Microbiota', 'weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",33.0,0.0311945,"Although symbiotic administration do not produce an effect on microbial diversity, an increase in short-chain fatty aciding producing bacteria and anti-inflammatory mediator signals such as Odoribacter and Lachnospira is shown.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gutiérrez-Repiso', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hernández-García', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'García-Almeida', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Bellido', 'Affiliation': 'División de Endocrinología, Complejo Hospitalario Universitario de Ferrol, Universidad de La Coruña, Ferrol, 15405, Spain.'}, {'ForeName': 'Gracia María', 'Initials': 'GM', 'LastName': 'Martín-Núñez', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Sánchez-Alcoholado', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Alcaide-Torres', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sajoux', 'Affiliation': 'Medical Department Pronokal, Pronokal Group, Barcelona, 08009, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Moreno-Indias', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, 29010, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.201900167'] 1645,32122634,An Integrated Infant and Young Child Feeding and Small-Quantity Lipid-based Nutrient Supplementation Program Is Associated with Improved Gross Motor and Communication Scores of Children 6-18 Months in the Democratic Republic of Congo.,"OBJECTIVE To evaluate the impact of an infant, young child feeding practices-small-quantity lipid nutrient supplements (SQ-LNS) intervention on child development scores in children aged 6-18 months in the Katanga Province, Democratic Republic of Congo (DRC). STUDY DESIGN We analyzed data of 2595 children from 2 health zones in a quasi-experimental design with preimplementation and postimplementation surveys to evaluate program impact on child development scores. Standard care was received in the comparison health zone and the intervention health zone received standard care plus enhanced infant, young child feeding practices with a monthly supply of 28 SQ-LNS sachets for up to 1 year. Program exposure and communication and motor domains of the Ages and Stages questionnaire were collected to assess changes in child development scores. A quasi-intent-to-treat and adjusted difference-in-difference analyses were used to quantify impact of the enhanced compared with the standard package. RESULTS In adjusted models contrasting endline with baseline, there was a greater relative increase in proportion of children with normal communication (difference-in-difference, +13.7% [95%CI, 7.9-19.6; P < .001] and gross motor scores, +7.4% [95% CI: 1.3-13.5; P < .001]) in the intervention vs comparison health zones. Further, in separate analyses among children of intervention health zone at endline, each additional SQ-LNS distribution was associated with +0.09 (95% CI, 0.03-0.16) z-score unit increase in gross motor scores (P < .01). CONCLUSIONS The integrated infant, young child feeding practice-SQ-LNS intervention was positively associated with larger relative improvements in measures of child communication and motor development in the Katanga province of DRC.",2020,"The integrated infant, young child feeding practice-SQ-LNS intervention was positively associated with larger relative improvements in measures of child communication and motor development in the Katanga province of DRC.","['children aged 6-18\xa0months in the Katanga Province, Democratic Republic of Congo (DRC', 'infant, young child feeding practices', '2595 children from 2 health zones in a quasi-experimental design with preimplementation and postimplementation surveys to evaluate program impact on child development scores']",['small-quantity lipid nutrient supplements (SQ-LNS) intervention'],"['gross motor scores', 'proportion of children with normal communication']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0206006', 'cui_str': 'Katanga'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",2595.0,0.0281091,"The integrated infant, young child feeding practice-SQ-LNS intervention was positively associated with larger relative improvements in measures of child communication and motor development in the Katanga province of DRC.","[{'ForeName': 'O Yaw', 'Initials': 'OY', 'LastName': 'Addo', 'Affiliation': 'Emory University Rollins School of Public, Hubert Department of Global Health & Global Health Institute, Atlanta, GA; McKing Consulting Corporation, Atlanta, GA; International Micronutrient Malnutrition Prevention and Control (IMMPaCT) Program, Nutrition Branch, Centers for Disease Control and Prevention, Atlanta, GA. Electronic address: Yaw.Addo@cdc.gov.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Tripp', 'Affiliation': 'International Micronutrient Malnutrition Prevention and Control (IMMPaCT) Program, Nutrition Branch, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Simeon', 'Initials': 'S', 'LastName': 'Nanama', 'Affiliation': 'UNICEF-DRC, Kinshasa and Lubumbashi, Democratic Republic of Congo, DRC.'}, {'ForeName': 'Bope', 'Initials': 'B', 'LastName': 'Albert', 'Affiliation': 'National Statistics Institute, Lubumbashi, DRC.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Sandalinas', 'Affiliation': 'UNICEF-WCARO, Dakar, Senegal.'}, {'ForeName': 'Ambroise', 'Initials': 'A', 'LastName': 'Nanema', 'Affiliation': 'UNICEF-DRC, Kinshasa and Lubumbashi, Democratic Republic of Congo, DRC.'}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Jefferds', 'Affiliation': 'International Micronutrient Malnutrition Prevention and Control (IMMPaCT) Program, Nutrition Branch, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Clayton', 'Affiliation': 'International Micronutrient Malnutrition Prevention and Control (IMMPaCT) Program, Nutrition Branch, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Ralph D', 'Initials': 'RD', 'LastName': 'Whitehead', 'Affiliation': 'International Micronutrient Malnutrition Prevention and Control (IMMPaCT) Program, Nutrition Branch, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Aashima', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': ""United Nations Children's Fund (UNICEF) Headquarters, New York, NY.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kupka', 'Affiliation': ""United Nations Children's Fund (UNICEF) Headquarters, New York, NY.""}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Locks', 'Affiliation': ""Harvard TH Chan School of Public Health, Boston, MA, USA; United Nations Children's Fund (UNICEF) Headquarters, New York, NY.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.01.023'] 1646,31440823,Randomized open-label phase II trial of 5-day aprepitant plus ondansetron compared to ondansetron alone in the prevention of chemotherapy-induced nausea-vomiting (CINV) in glioma patients receiving adjuvant temozolomide.,"PURPOSE CINV remains a distressing side effect experienced by glioma patients receiving multi-day temozolomide therapy, in spite of guideline-based antiemetic therapy with selective serotonin-receptor-antagonists. Antiemetic research with aprepitant has routinely excluded glioma patients. In this randomized open-label phase II study, use of a nonstandard 5-day regimen of aprepitant for glioma patients was investigated. METHODS One hundred thirty-six glioma patients receiving their first cycle of adjuvant temozolomide (150-200 mg/m 2 /day × 5 days every 28 days) were randomized to Arm-A (ondansetron 8 mg days 1-5 with aprepitant day 1: 125 mg, days 2-5: 80 mg) or Arm-B (ondansetron). Randomization was stratified by tumor grade and number of prior chemotherapy regimens. The primary endpoint was the percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescue medication over the 7-day study period. Secondary endpoints included CINV efficacy in the acute phase (≤ 24 h) and delayed phase (days 2-7), as well as safety and quality of life (QoL). RESULTS Patients were 61% male, 97% white, 48% with KPS > 90%, 60% non-smokers, mean age 54, 92% with low alcohol use, and 46% with a CINV history. The CC was 58.6% (Arm-A) and 54.5% (Arm-B). Acute-complete response (CR) rates, defined as CC on day 1 in Arm-A and -B, were 97.1% and 87.9%, respectively (p = 0.056). Treatment-related toxicities were mild or moderate in severity. CONCLUSIONS Aprepitant plus ondansetron may increase acute-CR, may have benefit regarding CINV's effect on QoL, and is safe for 5-day temozolomide compared to ondansetron. This study provides no evidence that aprepitant increases CC rate over ondansetron alone.",2020,The CC was 58.6% (Arm-A) and 54.5% (Arm-B).,"['One hundred thirty-six glioma patients receiving their first cycle of', 'glioma patients receiving adjuvant', 'glioma patients receiving multi-day', 'Patients were 61% male, 97% white, 48% with KPS >\u200990%, 60% non-smokers, mean age 54, 92% with low alcohol use, and 46% with a CINV history', '150-200\xa0mg/m']","['5-day aprepitant plus ondansetron', 'ondansetron 8\xa0mg\xa0days 1-5 with aprepitant day 1: 125\xa0mg, days 2-5: 80\xa0mg) or Arm-B (ondansetron', 'temozolomide therapy', 'adjuvant temozolomide', 'temozolomide', 'ondansetron']","['toxicities', 'percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescue medication', 'CINV efficacy in the acute phase (≤\u200924\xa0h) and delayed phase (days 2-7), as well as safety and quality of life (QoL', 'nausea-vomiting (CINV', 'CC rate', 'Acute-complete response (CR) rates']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1596254', 'cui_str': 'Ondansetron 8 MG [Zofran]'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0013973', 'cui_str': 'Emetic Agents'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",136.0,0.033613,The CC was 58.6% (Arm-A) and 54.5% (Arm-B).,"[{'ForeName': 'Mallika P', 'Initials': 'MP', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, Duke University Hospital, Durham, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Woodring', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Dina M', 'Initials': 'DM', 'LastName': 'Randazzo', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Henry S', 'Initials': 'HS', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Desjardins', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Healy', 'Affiliation': 'Duke Cancer Center Biostatistics, Durham, NC, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Herndon', 'Affiliation': 'Duke Cancer Center Biostatistics, Durham, NC, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'McSherry', 'Affiliation': 'Duke Cancer Center Biostatistics, Durham, NC, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Lipp', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Peters', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Affronti', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA. mary.affronti@duke.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05039-x'] 1647,31975352,Impaired Fibrinolysis Predicts Adverse Outcome in Acute Coronary Syndrome Patients with Diabetes: A PLATO Sub-Study.,"Hypofibrinolysis is a key abnormality in diabetes but the role of impaired clot lysis in predicting vascular events and mortality in this population is yet to be determined. We aimed to investigate the relationship between fibrin clot properties and clinical outcomes in patients with diabetes and recent acute coronary syndrome (ACS). Plasma samples were collected at hospital discharge from 974 ACS patients with diabetes randomised to clopidogrel or ticagrelor in the PLATO trial. A validated turbidimetric assay was employed to study fibrin clot lysis and maximum turbidity. One-year rates of cardiovascular (CV) death, spontaneous myocardial infarction (MI) and PLATO-defined major bleeding events were assessed after sample collection. Hazard ratios (HRs) were determined using Cox proportional analysis. After adjusting for CV risk factors, each 50% increase in lysis time was associated with increased risk of CV death/MI (HR 1.21; 95% confidence interval [CI] 1.02-1.44; p  = 0.026) and CV death alone (HR 1.38; 1.08-1.76; p  = 0.01). Similarly, each 50% increase in maximum turbidity was associated with increased risk of CV death/MI (HR 1.25; 1.02-1.53; p  = 0.031) and CV death alone (HR 1.49; 1.08-2.04; p  = 0.014). The relationship between lysis time and the combined outcome of CV death and MI remained significant after adjusting for multiple prognostic vascular biomarkers ( p  = 0.034). Neither lysis time nor maximum turbidity was associated with major bleeding events. Impaired fibrin clot lysis predicts 1-year CV death and MI in diabetes patients following ACS. CLINICAL TRIAL REGISTRATION:  URL: http://www.clinicaltrials.gov. Unique identifier NCT00391872.",2020,Neither lysis time nor maximum turbidity was associated with major bleeding events.,"['diabetes patients following ACS', 'Acute Coronary Syndrome Patients with Diabetes', '974 ACS patients with diabetes randomised to', 'patients with diabetes and recent acute coronary syndrome (ACS']","['clopidogrel or ticagrelor', 'fibrin clot lysis']","['lysis time', 'lysis time nor maximum turbidity', 'risk of CV death/MI', 'CV death and MI', 'cardiovascular (CV) death, spontaneous myocardial infarction (MI) and PLATO-defined major bleeding events', 'maximum turbidity', 'Hazard ratios (HRs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}]","[{'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4319582', 'cui_str': 'Turbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0043566', 'cui_str': 'PLATO'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",974.0,0.217135,Neither lysis time nor maximum turbidity was associated with major bleeding events.,"[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Sumaya', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Gabrysch', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Ajjan', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}]",Thrombosis and haemostasis,['10.1055/s-0039-1701011'] 1648,31422923,Ten-year outcomes from a randomised comparison of zotarolimus-eluting and sirolimus-eluting stents: the SORT OUT III study.,,2019,,[],['zotarolimus-eluting and sirolimus-eluting stents'],[],[],"[{'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]",[],,0.01768,,"[{'ForeName': 'Manan', 'Initials': 'M', 'LastName': 'Pareek', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Madsen', 'Affiliation': ''}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Warnakula Olesen', 'Affiliation': ''}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'Okkels Jensen', 'Affiliation': ''}, {'ForeName': 'Evald', 'Initials': 'E', 'LastName': 'Høj Christiansen', 'Affiliation': ''}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Dalby Kristensen', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Flensted Lassen', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': ''}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00503'] 1649,32069472,Efficacy of Magnesium Sulfate Treatment in Children with Acute Asthma.,"OBJECTIVE Systemic administration of magnesium sulfate (MgSO4) has been proposed as a treatment for pediatric patients with acute asthma. However, previous trials show mixed results and uncertain evidence of benefit. The aim of the study was to ascertain whether intravenous (IV) MgSO4 improves lung function parameters in children with acute asthma. METHODS This was a prospective clinical trial. All patients with acute asthma received 40-50 mg/kg or maximum 1,500 mg (>30 kg) of single dose IV MgSO4, administered over 60 min. Spirometry was conducted before and 15 min after MgSO4 infusion. RESULTS One hundred and fifteen children aged 6 to 17 years presenting with acute asthma and FEV1 between 40% and 75% of predicted were included. Then, the patients were classified into 2 groups; mild asthma attack (FEV1 ranged from 60% to 75%; n = 50) or moderate asthma attack (FEV1 ranged from 40% to 59%; n = 65). The baseline characteristics were similar in both groups. The mean percent predicted pre and post values for FEV1/FVC ratio (mild group: 82.59 ± 9.46 vs. 85.06 ± 8.95; moderate group: 77.31 ± 11.17 vs. 79.99 ± 11.77), FEV1 (mild group: 67.14 ± 4.99 vs. 72.29 ± 8.05; moderate group: 48.50 ± 6.81 vs. 53.78 ± 9.81), PEF (mild group: 65.49 ± 12.32 vs. 71.37 ± 12.96; moderate group: 47.56 ± 11.78 vs. 51.97 ± 13.98), and FEF25-75 (mild group: 58.20 ± 12.24 vs. 66.57 ± 16.95; moderate group: 37.77 ± 11.37 vs. 43.41 ± 14.19) showed a statistically significant (p < 0.05 for all) bronchodilator effect after MgSO4 infusion in both groups with few side effects. CONCLUSION Administration of IV MgSO4 was associated with improved pulmonary function in children with acute asthma.",2020,"The mean percent predicted pre and post values for FEV1/FVC ratio (mild group:82,59± 9,46 vs 85,06± 8,95; moderate group:77,31± 11,17 vs 79,99± 11,77),","['children with acute asthma', 'fifteen children aged 6 to 17 years presenting with acute asthma and FEV1 between 40% to 75% of predicted were included', 'patients were classified into 2 groups; mild asthma attack (FEV1 ranged 60% to 75%; n=50) or moderate asthma attack (FEV1 ranged 40% to 59%; n=65', 'All patients with acute asthma', 'One hundred', 'pediatric patients with acute asthma']","['IV MgSO4', 'SULPHATE', 'intravenous (IV) MgSO4', 'magnesium sulphate (MgSO4']","['pulmonary function', 'lung function measurements']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",115.0,0.416135,"The mean percent predicted pre and post values for FEV1/FVC ratio (mild group:82,59± 9,46 vs 85,06± 8,95; moderate group:77,31± 11,17 vs 79,99± 11,77),","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Özdemir', 'Affiliation': 'Pediatric Pulmonary Section, Department of Pediatrics, Mersin City Training and Research Hospital, Mersin, Turkey, aliozdemir@hotmail.com.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Doğruel', 'Affiliation': 'Pediatric Allergy Section, Department of Pediatrics, University of Cukurova, Adana, Turkey.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000506595'] 1650,31218668,"Safety and efficacy of topical formulations containing 0·5, 1 and 2% glycopyrronium bromide in patients with primary axillary hyperhidrosis: a randomized, double-blind, placebo-controlled study.",,2020,"Overall prevalence was reported to be 16% in German adults, with axillary hyperhidrosis being the most common form of HH.","['subjects with axillary hyperhidrosis', 'patients with primary axillary hyperhidrosis', '1,2']","['topical formulations containing 0.5, 1 and 2% glycopyrronium bromide', 'glycopyrronium bromide (GPB', 'placebo']","['Overall prevalence', 'safety and tolerability, efficacy and pharmacokinetics', 'Safety and efficacy']","[{'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.414405,"Overall prevalence was reported to be 16% in German adults, with axillary hyperhidrosis being the most common form of HH.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Masur', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Soeberdt', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Knie', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Abels', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18234'] 1651,32234359,The effect of gaming on accommodative and vergence facilities after exposure to virtual reality head-mounted display.,"BACKGROUND To investigate the change between accommodative and vergence facilities before and after exposure to gaming in a virtual reality (VR) device amongst participants with normal binocular visual function. METHODS 62 participants between the ages of 18-30 years with normal binocular visual function and inter-pupillary distances between 51 and 70 mm were selected for the study. Spectacle and contact lenses users were excluded. The experimental group (n = 42) was exposed to gaming using Samsung Gear VR(SM -R323) whilst the control group (n = 20) watched a television film projected on a two-dimensional screen at 1 m. Pre-test and post-test binocular amplitude-scaled facilities and vergence facilities were obtained for both groups after exposures of 25 min. RESULTS Binocular accommodative facilities for the experimental group had a mean pre-test and post-test facility of 11.14 ± 3.67 cpm and 13.38 ± 3.63 cpm, respectively, after gaming using VR device. The vergence facilities for the experimental group had a mean pre-test and post-test facility of 11.41 ± 3.86 cpm and 15.28 ± 4.93 cpm, respectively, after gaming using a VR device. Binocular accommodative facilities for the control group had a mean pre-test and post-test facility of 11.70 ± 3.2 cpm and 11.95 ± 3.4 cpm, respectively. Vergence facilities for the control group had a mean pre-test and post-test facility of 11.55 ± 6.4 cpm and 11.70 ± 4.9 cpm, respectively. The mean change for binocular accommodative facilities was 2.24 ± 3.43 cpm and 0.25 ± 1.25 cpm for the experimental and control group, respectively. The mean change for vergence facilities was 3.81 ± 3.09 cpm and 0.15 ± 2.72 cpm for the experimental and control group, respectively. Binocular accommodative facilities and vergence facility showed a statistically significant mean increase greater than the control group after gaming using a VR device using an independent t-test (p < 0.05). CONCLUSION The results showed that binocular accommodative facilities and vergence facilities increased after 25 min of VR gaming in emmetropic participants under 30 years of age with inter-pupillary distances between 51 mm and 70 mm.",2020,"Binocular accommodative facilities and vergence facility showed a statistically significant mean increase greater than the control group after gaming using a VR device using an independent t-test (p < 0.05). ","['participants with normal binocular visual function', '62 participants between the ages of 18-30 years with normal binocular visual function and inter-pupillary distances between 51 and 70 mm were selected for the study']",[],"['Binocular accommodative facilities', 'mean change for vergence facilities', 'mean change for binocular accommodative facilities', 'Binocular accommodative facilities and vergence facility', 'binocular accommodative facilities and vergence facilities', 'Vergence facilities']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",62.0,0.0234961,"Binocular accommodative facilities and vergence facility showed a statistically significant mean increase greater than the control group after gaming using a VR device using an independent t-test (p < 0.05). ","[{'ForeName': 'Alvin J', 'Initials': 'AJ', 'LastName': 'Munsamy', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa. Electronic address: munsamya1@ukzn.ac.za.'}, {'ForeName': 'Husna', 'Initials': 'H', 'LastName': 'Paruk', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Gopichunder', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Anela', 'Initials': 'A', 'LastName': 'Luggya', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Thembekile', 'Initials': 'T', 'LastName': 'Majola', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Sneliswa', 'Initials': 'S', 'LastName': 'Khulu', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}]",Journal of optometry,['10.1016/j.optom.2020.02.004'] 1652,32437664,"First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial.","BACKGROUND Addition of trastuzumab to first-line chemotherapy improves overall survival in patients with HER2-positive metastatic gastric cancer. We assessed the safety and activity of pembrolizumab in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer. METHODS This study was an investigator-initiated, open-label, non-randomised, single-arm, single centre, phase 2 trial in patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer. Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53%. Patients were eligible to receive an initial induction cycle of 200 mg flat dose of intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab. For subsequent cycles, patients received 130 mg/m 2 of intravenous oxaliplatin or 80 mg/m 2 of cisplatin on day 1, 850 mg/m 2 of oral capecitabine twice a day for 2 weeks followed by 1 week off (or intravenous 5-fluorouracil, 800 mg/m 2 per day on days 1-5), and a 200 mg flat dose of intravenous pembrolizumab, and 6 mg/kg of trastuzumab, administered on day 1 of each 3-week cycle. The primary endpoint was 6-month progression-free survival, defined as the proportion of patients alive and free of progression at 6 months, assessed in patients who received at least one dose of trastuzumab and pembrolizumab. The regimen would be considered worthy of further investigation if 26 or more of 37 patients were progression-free at 6 months. This trial is registered with ClinicalTrials.gov, NCT02954536, and is ongoing, but closed to enrolment. FINDINGS Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled. At the time of data cutoff on Aug 6, 2019, median follow-up among survivors was 13·0 months (IQR 11·7-23·5). The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months. The most common treatment-related adverse event of any grade was neuropathy, which was reported in 36 (97%) of 37 patients. The most common grade 3 or 4 adverse events were lymphocytopenia (seven [19%] patients with grade 3 and two [5%] with grade 4), grade 3 decreased electrolytes (six [16%] patients), and grade 3 anaemia (four [11%] patients). Serious adverse events occurred in two patients patients (both grade 3 nephritis leading to treatment discontinuation). Four patients discontinued pembrolizumab because of immune-related adverse events. There were no treatment-related deaths. INTERPRETATION Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer. A randomised phase 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric cancer is underway. FUNDING Merck & Co.",2020,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"['HER2-positive metastatic oesophagogastric cancer', 'Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53', 'patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer', 'first-line HER2-positive metastatic oesophagogastric cancer', 'HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer', 'Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled', 'first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer', 'patients with HER2-positive metastatic gastric cancer']","['oxaliplatin', 'intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab', 'trastuzumab and pembrolizumab', 'trastuzumab to first-line chemotherapy', 'trastuzumab and chemotherapy', 'capecitabine', 'cisplatin', 'pembrolizumab, and 6 mg/kg of trastuzumab', 'pembrolizumab versus placebo', 'First-line pembrolizumab and trastuzumab', '5-fluorouracil', 'pembrolizumab']","['safety and activity', '6-month progression-free survival, defined as the proportion of patients alive and free of progression', 'overall survival', 'grade 3 decreased electrolytes', 'grade 3 anaemia', 'efficacy and safety', 'Serious adverse events']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0740464', 'cui_str': 'Electrolytes NOS decreased'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.193351,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"[{'ForeName': 'Yelena Y', 'Initials': 'YY', 'LastName': 'Janjigian', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA. Electronic address: janjigiy@mskcc.org.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Maron', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Walid K', 'Initials': 'WK', 'LastName': 'Chatila', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Tri-Institutional Program in Computational Biology and Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Millang', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shweta S', 'Initials': 'SS', 'LastName': 'Chavan', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Alterman', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Segal', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc Z', 'Initials': 'MZ', 'LastName': 'Simmons', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Momtaz', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Shcherba', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zervoudakis', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Won', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kelsen', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Nagy', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lanman', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Ptashkin', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark T A', 'Initials': 'MTA', 'LastName': 'Donoghue', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Solit', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Schultz', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jaclyn F', 'Initials': 'JF', 'LastName': 'Hechtman', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30169-8'] 1653,32437690,Effect of Anodal Transcranial Direct Current Stimulation at the Right Dorsolateral Prefrontal Cortex on the Cognitive Function in Patients With Mild Cognitive Impairment: A Randomized Double-Blind Controlled Trial.,"OBJECTIVES To study the effect of anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC) on cognitive function and side effects in patients with mild cognitive impairment. DESIGN Experimental double-blind randomized, sham-controlled trial. SETTING Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital PARTICIPANTS: Volunteers (N=45) with mild cognitive impairment. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES The atDCS group (n=23) were stimulated at 2 mA for 20 minutes with the anode on the right DLPFC and the cathode on the left supraorbital area. The control group (n=22) received placebo stimulation. Baseline cognitive function was assessed using the Cambridge Neuropsychological Test Automated Battery test. Participants were treated 3 times per week for 4 weeks (12 sessions). Cognitive function and side effects were assessed immediately after the first stimulation, the last session, and 4 weeks after treatment. RESULTS Cambridge Neuropsychological Test Automated Battery results revealed a significant improvement in the accuracy of the visual sustained attention (VSA) in the atDCS group at all 3 time points, the spatial working memory and visual memory (VM) immediately after the first stimulation, and a decreased VM reaction time after 12 sessions. A long-lasting effect on VSA and VM were found 4 weeks after treatment. CONCLUSIONS Anodal tDCS over the right DLPFC enhanced the VSA, spatial working memory, and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions. A long-lasting effect on VSA and VM was found 4 weeks after treatment. This study corroborated atDCS as a safe technique to improve cognitive function.",2020,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[' Participants (45) who met the inclusion criteria', 'patients with mild cognitive impairment', 'Department of Rehabilitation Medicine, Tertiary Hospital SUBJECTS', 'patients with mild cognitive impairment (MCI']","['anodal transcranial direct current stimulation', 'anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC', 'placebo stimulation']","['Baseline cognitive function', 'reaction time of VM', 'VSA, SWM and VM accuracy', 'spatial working memory (SWM) and visual memory (VM', 'Cognitive function and side effects', 'VM reaction time', 'cognitive function', 'accuracy of the visual sustained attention (VSA', 'VSA and VM', 'Cambridge Neuropsychological Test Automated Battery (CANTAB) test', 'cognitive function and side effects']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",45.0,0.0855784,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[{'ForeName': 'Chernkhuan', 'Initials': 'C', 'LastName': 'Stonsaovapak', 'Affiliation': 'Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Solaphat', 'Initials': 'S', 'LastName': 'Hemrungroj', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of Neuroscience Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Terachinda', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Krisna', 'Initials': 'K', 'LastName': 'Piravej', 'Affiliation': 'Department of Neuroscience Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand; Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: Krisna.P@chula.ac.th.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.023'] 1654,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8'] 1655,31422680,Assessment of Bioabsorbable Hydroxyapatite for Secondary Bone Grafting in Unilateral Alveolar Clefts.,"PURPOSE To evaluate the utility and efficacy of bioabsorbable hydroxyapatite and collagen complex (HA/Col) for secondary bone grafting in unilateral alveolar clefts. PATIENTS AND METHODS Between 2015 and 2016, 21 patients with unilateral cleft lips and alveolar clefts were enrolled. In group I, a cancellous iliac bone graft was placed at the alveolar cleft (6 males, 5 females). In group II, a bioabsorbable HA/Col was placed at the alveolar cleft (4 males, 7 females). RESULTS The groups did not differ in age, cleft volume, or surgical duration. There was a significant difference in intraoperative blood loss between the 2 groups (6.7 ± 1.89 mL in group II vs 38.8 ± 9.73 mL in group I [ P < .01]). The use of patient-controlled intravenous analgesia was also significantly lower in group II than in group I (2.2 ± 1.9 times vs 12.2 ± 4.4 times [ P < .01]). Only 1 female in group II who had maxillary sinusitis did not achieve osteosynthesis. With the exception of this patient, the 12-month bone volumes in groups I and II were 0.567 ± 0.066 and 0.596 ± 0.073 mL, respectively, without significant difference ( P = .18). CONCLUSION Compared with an autogenous bone, bioabsorbable HA/Col significantly reduces postoperative pain. In addition, the use of HA/Col alone produced the same result as an autologous bone and is effective in filling the alveolar cleft.",2020,The use of patient-controlled intravenous analgesia was also significantly lower in group II than in group,"['Secondary Bone Grafting in Unilateral Alveolar Clefts', 'Between 2015 and 2016, 21 patients with unilateral cleft lips and alveolar clefts were enrolled']","['Bioabsorbable Hydroxyapatite', 'autogenous bone, bioabsorbable HA/Col', 'cancellous iliac bone graft', 'bioabsorbable HA/Col', 'bioabsorbable hydroxyapatite and collagen complex (HA/Col']","['postoperative pain', 'osteosynthesis', 'intraoperative blood loss', '12-month bone volumes']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392006'}]","[{'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C4521397', 'cui_str': 'US Military Commissioned Officer O6'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.031584,The use of patient-controlled intravenous analgesia was also significantly lower in group II than in group,"[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Orthodontics, Tokyo Dental College, Mihama Ward, Chiba, Japan.'}, {'ForeName': 'Tekenobu', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Orthodontics, Tokyo Dental College, Mihama Ward, Chiba, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Keio University School of Medicine, Shinjuku, Tokyo, Japan.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619866372'] 1656,31418814,"Quantity and Quality of Antibodies After Acellular Versus Whole-cell Pertussis Vaccines in Infants Born to Mothers Who Received Tetanus, Diphtheria, and Acellular Pertussis Vaccine During Pregnancy: A Randomized Trial.","BACKGROUND The blunting effect of pertussis immunization during pregnancy on infant antibody responses induced by whole-cell pertussis (wP) vaccination is not well-defined. METHODS This randomized controlled trial (NCT02408926) followed term infants born to mothers vaccinated with tetanus, diphtheria, and acellular pertussis (Tdap) vaccine during pregnancy in Thailand. Infants received either acellular pertussis (aP)- or wP-containing vaccine at 2, 4, 6, and 18 months of age. A comparison group comprised wP-vaccinated children born to mothers not vaccinated during pregnancy. Antibodies against pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) were evaluated using commercial enzyme-linked immunosorbent assays. Functionality of antibodies against Bordetella pertussis was measured using Bordetella pertussis growth inhibition assay. RESULTS After maternal Tdap vaccination, 158 infants vaccinated with aP-containing vaccines possessed higher antibody levels (P < .001) against all tested B. pertussis antigens postpriming compared to 157 infants receiving wP-containing vaccines. At 1 month postbooster, only anti-FHA and anti-PRN antibodies were still significantly higher (P < .001) in the aP group. Significantly higher anti-PT and anti-FHA (P < .001), but not anti-PRN immunoglobulin G, were observed among 69 wP-vaccinated infants born to control mothers compared with wP-vaccinated infants of Tdap-vaccinated mothers after primary and booster vaccination. The antibody functionality was higher in all wP-vaccinated infants at all times. CONCLUSIONS Maternal Tdap vaccination inhibited more pertussis-specific responses in wP-vaccinated infants compared to aP-vaccinated infants, and the control group of unvaccinated women had highest PT-specific responses, persisting until after the booster dose. Antibody functionality was better in the wP groups. CLINICAL TRIALS REGISTRATION NCT02408926.Infant whole-cell pertussis (wP) vaccine responses are blunted after maternal Tdap vaccination. Pertussis antibody titers are higher in acellular pertussis (aP)- than wP-vaccinated infants of immunized mothers, yet quality of antibodies, measured as serum-mediated bacterial growth inhibition, is better after wP than aP vaccination.",2020,"Significantly higher anti-PT and anti-FHA (p < 0.001), but not anti-PRN IgG, were observed among 69 wP-vaccinated infants born to control mothers compared to wP-vaccinated infants of Tdap-vaccinated mothers after primary and booster vaccination.","['infants born to mothers who received Tdap during pregnancy', 'infants born to mothers vaccinated with tetanus-diphtheria-acellular pertussis (Tdap)-vaccine during pregnancy in Thailand']","['acellular pertussis (aP)- or wP-containing vaccine', 'acellular versus whole cell pertussis vaccines', 'Antibodies against pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (PRN']","['antibody functionality', 'Antibody functionality', 'pertussis-specific responses', 'antibody levels', 'Quantity and quality of antibodies']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0020731', 'cui_str': 'Histamine-Sensitizing Factor'}, {'cui': 'C0136166', 'cui_str': 'pertactin'}, {'cui': 'C0558288', 'cui_str': 'prn'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",158.0,0.0249392,"Significantly higher anti-PT and anti-FHA (p < 0.001), but not anti-PRN IgG, were observed among 69 wP-vaccinated infants born to control mothers compared to wP-vaccinated infants of Tdap-vaccinated mothers after primary and booster vaccination.","[{'ForeName': 'Nasamon', 'Initials': 'N', 'LastName': 'Wanlapakorn', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Maertens', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}, {'ForeName': 'Sompong', 'Initials': 'S', 'LastName': 'Vongpunsawad', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jiratchaya', 'Initials': 'J', 'LastName': 'Puenpa', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thao Mai Phuong', 'Initials': 'TMP', 'LastName': 'Tran', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Belgium.'}, {'ForeName': 'Niel', 'Initials': 'N', 'LastName': 'Hens', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Thiriard', 'Affiliation': 'Université de Lille, Centre National de la Recherche Scientifique , Inserm, Centre Hospitalier Régional Universitaire Lille, Institut Pasteur de Lille, U1019-UMR8204, Center for Infection and Immunity of Lille, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Raze', 'Affiliation': 'Université de Lille, Centre National de la Recherche Scientifique , Inserm, Centre Hospitalier Régional Universitaire Lille, Institut Pasteur de Lille, U1019-UMR8204, Center for Infection and Immunity of Lille, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Locht', 'Affiliation': 'Université de Lille, Centre National de la Recherche Scientifique , Inserm, Centre Hospitalier Régional Universitaire Lille, Institut Pasteur de Lille, U1019-UMR8204, Center for Infection and Immunity of Lille, France.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Poovorawan', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Leuridan', 'Affiliation': 'Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz778'] 1657,31416765,Cost Analysis of Pneumatic Retinopexy versus Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment.,"PURPOSE To perform a cost-utility analysis and comparison between pneumatic retinopexy (PR) and pars plana vitrectomy (PPV) for primary rhegmatogenous retinal detachment (RRD) repair. DESIGN A cost-utility analysis using decision analysis. PARTICIPANTS There were no participants. METHODS A decision analysis model was constructed based on results from the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial to calculate the costs, lifetime usefulness, and lifetime cost per quality-adjusted life year (QALY) for the treatment of RRD with PR or PPV. Data from the Centers for Medicare and Medicaid Services were used to calculate the associated adjusted costs in facility and nonfacility practice settings. MAIN OUTCOME MEASURES Cost of intervention, utility gain over natural history, QALY gained, and cost per QALY. RESULTS The total imputed costs (all in 2019 United States dollars) for primary repair of RRD in facility and nonfacility settings were $4451 and $2456, respectively, in the PR group and $7108 and $4514, respectively, in the PPV group. The estimated lifetime QALYs gained were 5.9 and 5.4 in the PR and PPV groups, respectively. The cost per QALY for facility and nonfacility settings was $751 and $414, respectively, in the PR group and $1312 and $833, respectively, in the PPV group. CONCLUSIONS Cost-utility analysis of both PR and PPV demonstrated excellent results for both methods for RRD repair, with the metrics for PR somewhat more favorable independent of the practice settings (facility or nonfacility based).",2019,"The cost per QALY for facility and nonfacility settings was $751 and $414, respectively, in the PR group and $1312 and $833, respectively, in the PPV group. ","['primary rhegmatogenous retinal detachment (RRD) repair', 'Rhegmatogenous Retinal Detachment']","['pneumatic retinopexy (PR) and pars plana vitrectomy (PPV', 'Pneumatic Retinopexy versus Vitrectomy', 'Pneumatic Retinopexy versus Pars Plana Vitrectomy']","['total imputed costs', 'costs, lifetime usefulness, and lifetime cost per quality-adjusted life year (QALY', 'Cost of intervention, utility gain over natural history, QALY gained, and cost per QALY', 'cost per QALY for facility and nonfacility settings', 'estimated lifetime QALYs gained']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy (procedure)'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach (procedure)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0362475,"The cost per QALY for facility and nonfacility settings was $751 and $414, respectively, in the PR group and $1312 and $833, respectively, in the PPV group. ","[{'ForeName': 'Abdelrahman M', 'Initials': 'AM', 'LastName': 'Elhusseiny', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Ophthalmology, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Yannuzzi', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Smiddy', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: wsmiddy@med.miami.edu.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.06.003'] 1658,32495974,Double recurrence of double cancers: Rhabdomyosarcoma and secondary AML.,,2020,,[],[],[],[],[],[],,0.361475,,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kajita', 'Affiliation': 'Division of Hematology/Oncology, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Division of Hematology/Oncology, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Makimoto', 'Affiliation': 'Division of Pathology and Laboratory Medicine, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Division of Pathology, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yuza', 'Affiliation': 'Division of Hematology/Oncology, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14172'] 1659,32496203,Feasibility and Acceptability of a Text Message-Based Intervention to Reduce Overuse of Alcohol in Emergency Department Patients: Controlled Proof-of-Concept Trial.,"BACKGROUND Emergency department (ED) patients have high rates of risky alcohol use, and an ED visit offers an opportunity to intervene. ED-based screening, brief intervention, and referral to treatment (SBIRT) reduces alcohol use and health care costs. Mobile health (mHealth) interventions may expand the impact of SBIRTs but are understudied in low-resource ED populations. OBJECTIVE The objective of this study was to assess the feasibility of and patient satisfaction with a text-based mHealth extension of an ED screening program to reduce risky alcohol use in low-income, urban patients. METHODS Research assistants screened a convenience sample of ED patients in person for risky alcohol use via the Alcohol Use Disorders Identification Test (AUDIT). Patients who reported AUDIT scores ≥8 and <20 were informed of their AUDIT score and risk. RAs invited patients with SMS text message-capable phones to receive mROAD (mobilizing to Reduce Overuse of Alcohol in the ED), an SMS text message-based extension of the ED screening program. mROAD is a 7-day program of twice-daily SMS text messages based on the National Institutes of Health's Rethinking Drinking campaign. Participants were allocated to a control group (daily sham text messages without specific guidance on behaviors, such as ""Thanks for taking part!"") or to the mROAD intervention group. Patients were interviewed at 30 days to assess acceptability, satisfaction, and changes in drinking behavior. Satisfaction was examined descriptively. Pre and post measurements of drinking behaviors and motivation were compared, as were differences in change scores between the intervention arms. RESULTS Of 1028 patients screened, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 23/95 (24%) of those patients did not own an SMS text messaging-capable phone; this left 72/95 (76%) eligible patients. Among eligible participants, 48/72 (67%) agreed to enroll; 31/48 (65%) achieved follow-up (18/24 (75%) in the intervention group and 13/24 (55%) in the control group). Participants who completed follow-up reported high satisfaction. Changes in behavior were similar between the arms. Overall, the number of drinking days reported in the prior 30 days decreased by 5.0 (95% CI 1.7-8.3; P=.004), and the number of heavy drinking days decreased by 4.1 (95% CI 1.0 to 7.15, P=.01). Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire. The were no statistical differences in drinking days, heavy drinking days, or motivation to change between the arms. CONCLUSIONS The mROAD trial was feasible. Over three-quarters of ED patients with risky alcohol use owned a text message-capable phone, and two-thirds of these patients were willing to participate; only 1 patient opted out of the intervention. Although 35% of patients were lost to follow-up at 30 days, those patients who did follow up had favorable impressions of the program; more than 90% reported that SMS text messages were a ""good way to teach,"" and 89% of intervention arm participants enjoyed the program and found that the messages were motivating. Both the mROAD and sham message groups showed promising changes in alcohol use and motivation to change. mROAD is a feasible intervention that may reduce rates of risky alcohol use in ED patients. TRIAL REGISTRATION ClinicalTrials.gov NCT02158949; https://clinicaltrials.gov/ct2/show/NCT02158949.",2020,"Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire.","['Research assistants screened a convenience sample of ED patients in person for risky alcohol use via the Alcohol Use Disorders Identification Test (AUDIT', 'ED patients', 'low-income, urban patients', 'Emergency Department Patients', '1028 patients screened, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 23/95 (24%) of those patients did not own an SMS text messaging-capable phone; this left 72/95 (76%) eligible patients']","['Text Message-Based Intervention', 'text-based mHealth extension of an ED screening program', 'Mobile health (mHealth) interventions', 'control group (daily sham text messages without specific guidance on behaviors, such as ""Thanks for taking part!"") or to the mROAD intervention group']","['drinking behaviors and motivation', 'Changes in behavior', 'drinking days, heavy drinking days, or motivation to change between the arms', 'acceptability, satisfaction, and changes in drinking behavior', 'Satisfaction', 'number of drinking days', 'number of heavy drinking days']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.101456,"Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burner', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Terp', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ford Bench', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Chun Nok', 'Initials': 'CN', 'LastName': 'Lam', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Jesus R', 'Initials': 'JR', 'LastName': 'Torres', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Menchine', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/17557'] 1660,31558730,Network-based Responses to the Psychomotor Vigilance Task during Lapses in Adolescents after Short and Extended Sleep.,"Neuroimaging studies of the Psychomotor Vigilance Task (PVT) have revealed brain regions involved in attention lapses in sleep-deprived and well-rested adults. Those studies have focused on individual brain regions, rather than integrated brain networks, and have overlooked adolescence, a period of ongoing brain development and endemic short sleep. This study used functional MRI (fMRI) and a contemporary analytic approach to assess time-resolved peri-stimulus response of key brain networks when adolescents complete the PVT, and test for differences across attentive versus inattentive periods and after short sleep versus well-rested states. Healthy 14-17-year-olds underwent a within-subjects randomized protocol including 5-night spans of extended versus short sleep. PVT was performed during fMRI the morning after each sleep condition. Event-related independent component analysis (eICA) identified coactivating functional networks and corresponding time courses. Analysis of salient time course characteristics tested the effects of sleep condition, lapses, and their interaction. Seven eICA networks were identified supporting attention, executive control, motor, visual, and default-mode functions. Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks. Well-circumscribed networks respond during the PVT in adolescents, with timing and intensity impacted by attentional lapses regardless of experimentally shortened or extended sleep.",2019,"Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks.","['Healthy 14-17-year-olds', 'Adolescents after Short and Extended Sleep']","['functional MRI (fMRI', 'PVT', '5-night spans of extended versus short sleep', 'Psychomotor Vigilance Task (PVT']","['sleep condition, lapses, and their interaction']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0320693,"Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks.","[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'DiFrancesco', 'Affiliation': ""Pediatric Neuroimaging Research Consortium, Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. mark.difrancesco@cchmc.org.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Van Dyk', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Altaye', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'S P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash Institute for Cognitive and Clinical Neuroscience, School of Psychological Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}]",Scientific reports,['10.1038/s41598-019-50180-6'] 1661,32441852,Effectiveness and Safety of Fast Enteral Advancement in Preterm Infants Between 1000 and 2000 g of Birth Weight.,"BACKGROUND The advancement of enteral nutrition in premature infants is still controversial. Clinicians must provide adequate caloric intake but avoiding feeding intolerance and necrotizing enterocolitis (NEC). The aim of this study was to establish the safety and effectiveness of fast enteral advancement by comparing it with traditional advancement. METHODS This is a controlled randomized clinical trial. Feeding was advanced at 30 mL/kg/d vs 20 mL/kg/d in premature infants under 34 weeks between 1000 and 1499g birth weight, and at 40 mL/kg/d vs 20 mL/kg/day in those weighing 1500-1999 g. Outcomes included time to reach total enteral nutrition, days of parenteral nutrition (PN) and/or intravenous fluid (IVF), days to recover birth weight, episodes of feeding intolerance, growth and weight gain at 40 weeks, sepsis, hypoglycemia, hyperbilirubinemia, NEC, and mortality. Student t-test or Mann-Whitney U test, Fisher test or χ 2 test, and multiple linear regression were used. RESULTS Differences were found in days to reach total enteral nutrition (slow: 7 [IQR(interquartile range), 6-9], fast: 4 [IQR, 4-6]; P < .001) and days of IVF or PN (slow: 6 [IQR, 4-8], fast: 3 [IQR, 3-5]; P < .001). Fast advancement decreases time to total enteral nutrition by 3 days and PN and/or IVF by up to 5 days. There were no differences in other outcomes. CONCLUSIONS Fast enteral advancement decreases the days to reach total enteral nutrition and the days of PN and/or IVF without causing greater feeding intolerance. Additional studies are required for more evidence.",2020,"There were no differences in feeding intolerance episodes or other outcomes. ","['Preterm Infants Between 1000 and 2000 g of Birth Weight', 'premature infants']",['Fast Enteral Advancement'],"['days of IVF or PN', 'Effectiveness and Safety', 'time to reach total enteral nutrition, days of parenteral nutrition and/or intravenous fluids, days to recover birth weight, episodes of feeding intolerance, growth and weight gain at 40 weeks, sepsis, hypoglycaemia, hyperbilirubinemia, NEC and mortality', 'feeding intolerance episodes', 'total enteral nutrition']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}]",,0.0922506,"There were no differences in feeding intolerance episodes or other outcomes. ","[{'ForeName': 'Adriana Del Pilar', 'Initials': 'ADP', 'LastName': 'Montealegre-Pomar', 'Affiliation': 'Pediatrics Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Cra 7#40-62, Bogotá, 11001, Colombia.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Bertolotto-Cepeda', 'Affiliation': 'Pediatrics Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Cra 7#40-62, Bogotá, 11001, Colombia.'}, {'ForeName': 'Yoliseth', 'Initials': 'Y', 'LastName': 'Romero-Marquez', 'Affiliation': 'Pediatrics Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Cra 7#40-62, Bogotá, 11001, Colombia.'}, {'ForeName': 'Kelly José', 'Initials': 'KJ', 'LastName': 'Muñoz-Ramírez', 'Affiliation': 'Pediatrics Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Cra 7#40-62, Bogotá, 11001, Colombia.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1925'] 1662,31422028,Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis.,"BACKGROUND Phase 3 clinical data has shown higher proportions of patients with objective response, longer response duration, and longer overall survival with nivolumab versus docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival. METHODS We pooled data from four clinical studies of nivolumab in patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003) to evaluate survival outcomes. Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included. Comparisons of nivolumab versus docetaxel included all randomised patients from the phase 3 CheckMate 017 and 057 studies. We did landmark analyses by response status at 6 months to determine post-landmark survival outcomes. We excluded patients who did not have a radiographic tumour assessment at 6 months. Safety analyses included all patients who received at least one dose of nivolumab. FINDINGS Across all four studies, 4-year overall survival with nivolumab was 14% (95% CI 11-17) for all patients (n=664), 19% (15-24) for those with at least 1% PD-L1 expression, and 11% (7-16) for those with less than 1% PD-L1 expression. In CheckMate 017 and 057, 4-year overall survival was 14% (95% CI 11-18) in patients treated with nivolumab, compared with 5% (3-7) in patients treated with docetaxel. Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52 (0·37-0·71) for nivolumab and 0·80 (0·61-1·04) for docetaxel. Long-term data did not show any new safety signals. INTERPRETATION Patients with advanced NSCLC treated with nivolumab achieved a greater duration of response compared with patients treated with docetaxel, which was associated with a long-term survival advantage. FUNDING Bristol-Myers Squibb.",2019,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","['patients with previously treated advanced non-small-cell lung cancer (NSCLC', 'patients from the phase 3 CheckMate 017 and 057 studies', 'patients who did not have a radiographic tumour assessment at 6 months', 'patients with previously treated advanced non-small-cell lung cancer', 'patients who received at least one dose of nivolumab', 'patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003', 'Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included']","['docetaxel', 'nivolumab versus docetaxel', 'nivolumab or docetaxel', 'nivolumab']","['survival outcomes', 'duration of response', '4-year overall survival with nivolumab', '4-year overall survival', 'Survival subsequent to response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]",664.0,0.50406,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","[{'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. Electronic address: scott.antonia@duke.edu.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Castro Carpeño', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pluzanski', 'Affiliation': 'Klinika Nowotworow Pluca i Klatki Piersiowej, Centrum Onkologii-Instytut Im Marii Sklodowskiej-Curie, Warsaw, Poland.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Burgio', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garassino', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Crinò', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Institut Gustave Roussy, Department of Medical Oncology, Thoracic Group, Villejuif, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wojcik-Tomaszewska', 'Affiliation': 'Wojewodzkie Centrum Onkologii, Gdańsk, Poland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Otterson', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Penrod', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30407-3'] 1663,31415003,Randomized Comparison of Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis After Esophagectomy.,"OBJECTIVE This prospective randomized phase-II trial examined whether gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis(RY) minimized gastroduodenal reflux and delayed gastric emptying compared with standard gastric reconstruction. SUMMARY BACKGROUND DATA There is no established standard surgical procedure to prevent both gastroduodenal reflux and delayed gastric emptying simultaneously. METHODS Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction were randomly allocated to standard gastric reconstruction (non-RY, n = 31) or gastric reconstruction with duodenal diversion plus RY (n = 29) groups. Primary endpoint was quality of life assessed by DAUGS-32 score 1 year after surgery. Secondary endpoints were the extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status. RESULTS Preoperative clinicopathological characteristics and postoperative morbidity did not differ significantly between groups. However, operation time and blood loss volume were significantly higher in the RY group. Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group. Postoperative endoscopic examination showed residual gastric content in 7 of 17 patients in the non-RY group but in none in the RY group (P = 0.012). Quality of life was significantly favorable in the RY group with regard to reflux symptoms and food passage dysfunction. Postoperative body weight changes, serum albumin levels, and peripheral blood lymphocyte counts were not significantly different between groups. CONCLUSION Gastric reconstruction with duodenal diversion plus RY is effective in improving both gastroduodenal reflux and delayed gastric emptying.",2020,"Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group.",['Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction'],"['Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis', 'standard gastric reconstruction', 'gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis(RY', 'standard gastric reconstruction (non-RY, n = 31) or gastric reconstruction with duodenal diversion plus RY']","['quality of life assessed by DAUGS-32 score 1 year after surgery', 'Quality of life', 'gastroduodenal reflux and delayed gastric emptying', 'operation time and blood loss volume', 'Preoperative clinicopathological characteristics and postoperative morbidity', 'extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status', 'gastroduodenal reflux and delayed gastric emptying simultaneously', 'Postoperative body weight changes, serum albumin levels, and peripheral blood lymphocyte counts', 'reflux symptoms and food passage dysfunction', 'Pancreatic amylase concentrations', 'residual gastric content']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0442179', 'cui_str': 'Retrosternal (qualifier value)'}, {'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}]","[{'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y Anastomosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal (qualifier value)'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0227306', 'cui_str': 'Duodenal juice (substance)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0301812', 'cui_str': 'Pancreatic amylase (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0038352', 'cui_str': 'Stomach Contents'}]",60.0,0.0257535,"Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group.","[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Motoori', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Sakon', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}]",Annals of surgery,['10.1097/SLA.0000000000003557'] 1664,32437921,Central Review of Radiation Therapy Planning Among Patients with Breast-Conserving Surgery: Results from a Quality Assurance Process Integrated into the INSEMA Trial.,"PURPOSE After publication of the radiation field design in the American College of Surgeons Oncology Group Z0011 trial, a radiation therapy quality assurance review was integrated into the Intergroup-Sentinel-Mamma (INSEMA) trial. We aimed to investigate the role of patient characteristics, extent of axillary surgery, and radiation techniques for dose distribution in ipsilateral axillary levels. METHODS AND MATERIALS INSEMA (NCT02466737) has randomized 5542 patients who underwent breast-conserving surgery. Of these, 276 patients from 108 radiation therapy facilities were included in the central review, using the planning records of the first 3 patients treated at each site. RESULTS Of the 276 patients, 41 had major deviations (ie, no axillary contouring or submission of insufficient records) leading to exclusion. A total of 235 (85.1%) radiation therapy planning records were delineated according to the INSEMA protocol, including 9 (3.8%) cases with minor deviations. At least 25% of INSEMA patients were unintentionally treated with ≥95% of the prescribed breast radiation dose in axillary level I. Approximately 50% of patients were irradiated with a median radiation dose of more than 85% of prescription dose in level I. Irradiated volumes and applied doses were significantly lower in levels II and III compared with level I. However, 25% of patients still received a median radiation dose of ≥75% of prescription dose to level II. Subgroup analysis revealed a significant association between incidental radiation dose in the axilla and obesity. Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution. CONCLUSIONS Assuming ≥80% of prescribed breast dose as the optimal dose for curative radiation of low-volume disease in axillary lymph nodes, at least 50% of reviewed INSEMA patients received an adequate dose in level I, even with contemporary 3-dimensional techniques. Dose coverage was much less in axillary levels II and III, and far below therapeutically relevant doses.",2020,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution. ","['axillary lymph nodes', '5,542 patients with breast-conserving surgery', '276 patients', '276 patients from 108 radiotherapy facilities were included in the central review using the planning records of the first three patients treated at each site', 'patients with breast-conserving surgery']","['radiation therapy planning', 'XXX']",[],"[{'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",[],5542.0,0.0393912,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution. ","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Angrit', 'Initials': 'A', 'LastName': 'Stachs', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': 'Breast Center, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Wolter', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'Department of Obstetrics and Gynecology, Interdisciplinary Breast Center, Esslingen, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Zierhut', 'Affiliation': 'Department of Radio-Oncology and Radiotherapy, Klinikum Hanau GmbH, Hanau, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sedlmayer', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kaiser', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Reitsamer', 'Affiliation': 'Breast Center, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Breast Unit, University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Toralf', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany. Electronic address: toralf.reimer@med.uni-rostock.de.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.042'] 1665,32438071,Baseline urinary metabolites predict albuminuria response to spironolactone in type 2 diabetes.,"The mineralocorticoid receptor antagonist spironolactone significantly reduces albuminuria in subjects with diabetic kidney disease, albeit with a large variability between individuals. Identifying novel biomarkers that predict response to therapy may help to tailor spironolactone therapy. We aimed to identify a set of metabolites for prediction of albuminuria response to spironolactone in subjects with type 2 diabetes. Systems biology molecular process analysis was performed a priori to identify metabolites linked to molecular disease processes and drug mechanism of action. Individual subject data and urine samples were used from 2 randomized placebo controlled double blind clinical trials (NCT01062763, NCT00381134). A urinary metabolite score was developed to predict albuminuria response to spironolactone therapy using penalized ridge regression with leave-one-out cross validation. Bioinformatic analysis identified a set of 18 metabolites linked to a diabetic kidney disease molecular model and potentially affected by spironolactone mechanism of action. Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively. In the test cohort, UACR reduction was higher in the lowest tertile of the baseline urinary metabolite score compared with middle and upper tertiles -58% (25th to 75% percentile -78 to 33), -28% (25th to 75% percentile -46 to 8), -40% (25th to 75% percentile -52% to 31), respectively, P = 0.001 for trend). In the replication cohort, UACR reduction was -54% (25th to 75% percentile -65 to -50), -41 (25th to 75% percentile -46% to 30), and -17% (25th to 75% percentile -36 to 5), respectively, P = 0.010 for trend). We identified a set of 18 urinary metabolites through systems biology to predict albuminuria response to spironolactone in type 2 diabetes. These data suggest that urinary metabolites may be used as a tool to tailor optimal therapy and move in the direction of personalized medicine.",2020,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","['subjects with diabetic kidney disease', 'type 2 diabetes', 'subjects with type 2 diabetes']","['spironolactone', 'mineralocorticoid receptor antagonist spironolactone', 'Spironolactone', 'spironolactone therapy', 'placebo']","['baseline urinary metabolite score', 'UACR reduction', 'albuminuria response', 'UACR relative']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0356557,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perco', 'Affiliation': 'Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Oxlund', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Uzma F', 'Initials': 'UF', 'LastName': 'Mehdi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hankemeier', 'Affiliation': 'Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Ib A', 'Initials': 'IA', 'LastName': 'Jacobsen', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: m.pena@umcg.nl.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.04.010'] 1666,31432432,Effects of Tai Chi on beta endorphin and inflammatory markers in older adults with chronic pain: an exploratory study.,"The purpose of this exploratory study was to examine the effects of Tai Chi on blood levels of beta endorphin (β-endorphin) and inflammatory markers in older adults with chronic pain. Forty community-dwelling older adults with chronic pain were randomized to Tai Chi or light physical exercise, and each offered twice weekly for 12 weeks. Following the 12-week intervention, neither Tai Chi nor light physical exercise changed levels of β-endorphin and inflammatory markers. However, in older adults who completed 70% or more classes, Tai Chi significantly lowered levels of β-endorphin (p < 0.05), whereas light physical exercise did not change levels of β-endorphin. The results suggest that Tai Chi may reduce levels of β-endorphin in older adults with chronic pain. Future studies are needed to better understand the role of the opioid analgesic system and immune system in regulating pain with aging and the long-term effects of Tai Chi on pain-related biomarkers.",2020,"Following the 12-week intervention, neither Tai Chi nor light physical exercise changed levels of β-endorphin and inflammatory markers.","['Forty community-dwelling older adults with chronic pain', 'older adults with chronic pain']","['Tai Chi nor light physical exercise', 'Tai Chi', 'Tai Chi or light physical exercise']","['levels of β-endorphin', 'light physical exercise', 'beta endorphin and inflammatory markers', 'β-endorphin and inflammatory markers', 'blood levels of beta endorphin (β-endorphin) and inflammatory markers']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014242', 'cui_str': 'Endorphins'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005210', 'cui_str': 'beta-Endorphin (1-31)'}, {'cui': 'C0005768'}]",40.0,0.0485784,"Following the 12-week intervention, neither Tai Chi nor light physical exercise changed levels of β-endorphin and inflammatory markers.","[{'ForeName': 'Tongjian', 'Initials': 'T', 'LastName': 'You', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA. tongjian.you@umb.edu.'}, {'ForeName': 'Elisa F', 'Initials': 'EF', 'LastName': 'Ogawa', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Saurja', 'Initials': 'S', 'LastName': 'Thapa', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Yurun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 02215, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': 'Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Leveille', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01316-1'] 1667,31209171,Training on Abacus-Based Mental Calculation Enhances Visuospatial Working Memory in Children.,"Abacus-based mental calculation (AMC) involves temporary storage and manipulation of an imaginary abacus closely related to the function of visuospatial working memory (VSWM). The present study thus investigated the effects of AMC training on VSWM and its neural correlates. A total of 144 human subjects (67 boys) were assigned to AMC or control groups at their entry to primary school. The AMC group received 2 h AMC training per week for 5 school years, whereas the control group spent the time in activities, such as conventional calculation and reading. Raven's Intelligence Test was administered both before and after training. Two arithmetic tests and a VSWM task were conducted after training. Among these participants, fMRI data were collected from 64 children for the VSWM task. Behavioral results indicated that the AMC group outperformed controls on both arithmetic and VSWM tasks, but not on Raven's Intelligence Test. While the two groups activated similar regions during the VSWM task, the AMC group showed greater activation than the controls in frontal, parietal, and occipital areas. Interestingly, the activation of right middle frontal gyrus mediated the relation between the arithmetic ability and the VSWM performance in the AMC group, suggesting that the frontal region may be the neural substrate underlying the transfer effect from AMC training to VSWM. Although the transfer effects seem quite limited considering the length and intensity of the training, these findings suggest that long-term AMC training not only improves arithmetic ability but also has a potential positive effect on VSWM. SIGNIFICANCE STATEMENT Plasticity of working memory is one of the most rapidly expanding research fields in the developmental and cognitive sciences. Previous studies suggest that abacus-based mental calculation (AMC) relies on a visuospatial imaginary strategy, which is closely related to visuospatial working memory (VSWM). However, the impacts of AMC training on VSWM and the underlying neural basis remain unclear. Here, we found that AMC training enhanced VSWM in children, which was accompanied by altered activation in frontal, parietal, and occipital areas. Moreover, we observed that activation in right middle frontal gyrus played a significant mediation role in the transfer of AMC training to VSWM. These findings provide a new perspective to VSWM training and also advance our understanding of related brain plasticity.",2019,"While the two groups activated similar regions during the VSWM task, the AMC group showed greater activation than the controls in frontal, parietal and occipital areas.","['children', 'One hundred and forty-four human subjects (67 boys']","['AMC', 'Abacus-based mental calculation (AMC', '2-hour AMC training', 'AMC training']","[""Raven's intelligence test"", 'arithmetic and VSWM tasks', 'VSWM performance', 'arithmetic ability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0382121', 'cui_str': '(3H)-AMC'}, {'cui': 'C3878323', 'cui_str': 'Abacus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1449597', 'cui_str': 'Ravens'}, {'cui': 'C0021705', 'cui_str': 'Intelligence Tests'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",144.0,0.0146081,"While the two groups activated similar regions during the VSWM task, the AMC group showed greater activation than the controls in frontal, parietal and occipital areas.","[{'ForeName': 'Chunjie', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Tianyong', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Fengji', 'Initials': 'F', 'LastName': 'Geng', 'Affiliation': 'Department of Curriculum and Learning Sciences, College of Education, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310027, China, and huyuzheng@zju.edu.cn chenfy@zju.edu.cn.'}, {'ForeName': 'Yunqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of International Studies, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Huafeng', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Modern Optical Instrumentation, Department of Optical Engineering, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Feiyan', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou 310027, China, huyuzheng@zju.edu.cn chenfy@zju.edu.cn.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3195-18.2019'] 1668,31116891,Effect of local infiltration with oxytocin on hemodynamic response to surgical incision and postoperative pain in patients having open laparoscopic surgery under general anesthesia.,"BACKGROUND Preemptive analgesia encompasses different perioperative interventions that have the final aim of decreasing postoperative pain and improving recovery. Recently, peripheral analgesic effects of oxytocinergic modulation have been suggested. In this regard, we tested the potential analgesic effects of subcutaneous oxytocin (OT) infiltration in patients submitted to laparoscopic cholecystectomy. METHODS Thirty patients with similar general characteristics and medical physical conditions were evaluated. The patients were assigned by simple random selection to one of three groups: (a) OT group (n = 10), which received preincisional subcutaneous OT (4 µg/4 ml saline) in the surgical sites for trocar placements; (b) Lidocaine group (n = 10), which received subcutaneous lidocaine 1% (4 ml) in the surgical sites; and (c) Control group (n = 10), which did not receive any treatment. Then we measured the effect of those treatments on the hemodynamic variations produced as responses to the surgical incisions and trocar insertions (open port placements using the Hasson technique). Moreover, we assessed the intensity of postoperative pain with the visual analogue scale during recovery and 24 hr after surgery. RESULTS Hemodynamic parameters were stable in both intervention groups (subcutaneous OT and lidocaine) during the surgical incisions and trocar placements, whereas a most likely sympathetic activation due to trocar insertions (open port placements) was not blunted in the placebo group. Furthermore, postoperative pain was diminished in both OT and lidocaine groups when compared to the control group. CONCLUSIONS Preincisional subcutaneous OT administration reduced the hemodynamic response produced by the latter. Furthermore, OT also diminished postoperative pain.",2019,"RESULTS Hemodynamic parameters were stable in both intervention groups (subcutaneous OT and lidocaine) during the surgical incisions and trocar placements, whereas a most likely sympathetic activation due to trocar insertions (open port placements) was not blunted in the placebo group.","['patients submitted to laparoscopic cholecystectomy', 'patients having open laparoscopic surgery under general anesthesia', 'Thirty patients with similar general characteristics and medical physical conditions were evaluated']","['Lidocaine', 'lidocaine', 'preincisional subcutaneous OT (4\xa0µg/4 ml saline', 'subcutaneous lidocaine', 'subcutaneous oxytocin (OT) infiltration', 'Preincisional subcutaneous OT', 'oxytocin']","['postoperative pain', 'hemodynamic response', 'intensity of postoperative pain with the visual analogue scale', 'sympathetic activation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",30.0,0.0233861,"RESULTS Hemodynamic parameters were stable in both intervention groups (subcutaneous OT and lidocaine) during the surgical incisions and trocar placements, whereas a most likely sympathetic activation due to trocar insertions (open port placements) was not blunted in the placebo group.","[{'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Zayas-González', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Abimael', 'Initials': 'A', 'LastName': 'González-Hernández', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Manzano-García', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Donaciano', 'Initials': 'D', 'LastName': 'Hernández-Rivero', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'García-Cuevas', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Granados-Mortera', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Vaca-Aguirre', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Flores-Fierro', 'Affiliation': 'Hospital Regional de Petróleos Mexicanos, Salamanca, México.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Martínez-Lorenzana', 'Affiliation': 'Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Condés-Lara', 'Affiliation': 'Departamento de Neurobiología del Desarrollo y Neurofisiología, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}]","European journal of pain (London, England)",['10.1002/ejp.1427'] 1669,31416685,"Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial.","BACKGROUND Transoral robotic surgery (TORS) with concurrent neck dissection has supplanted radiotherapy in the USA as the most common treatment for oropharyngeal squamous cell carcinoma (OPSCC), yet no randomised trials have compared these modalities. We aimed to evaluate differences in quality of life (QOL) 1 year after treatment. METHODS The ORATOR trial was an investigator-initiated, multicentre, international, open-label, parallel-group, phase 2, randomised study. Patients were enrolled at six hospitals in Canada and Australia. We randomly assigned (1:1) patients aged 18 years or older, with Eastern Cooperative Oncology Group scores of 0-2, and with T1-T2, N0-2 (≤4 cm) OPSCC tumour types to radiotherapy (70 Gy, with chemotherapy if N1-2) or TORS plus neck dissection (with or without adjuvant chemoradiotherapy, based on pathology). Following stratification by p16 status, patients were randomly assigned using a computer-generated randomisation list with permuted blocks of four. The primary endpoint was swallowing-related QOL at 1 year as established using the MD Anderson Dysphagia Inventory (MDADI) score, powered to detect a 10-point improvement (a clinically meaningful change) in the TORS plus neck dissection group. All analyses were done by intention to treat. This study is registered with ClinicalTrials.gov (NCT01590355) and is active, but not currently recruiting. FINDINGS 68 patients were randomly assigned (34 per group) between Aug 10, 2012, and June 9, 2017. Median follow-up was 25 months (IQR 20-33) for the radiotherapy group and 29 months (23-43) for the TORS plus neck dissection group. MDADI total scores at 1 year were mean 86·9 (SD 11·4) in the radiotherapy group versus 80·1 (13·0) in the TORS plus neck dissection group (p=0·042). There were more cases of neutropenia (six [18%] of 34 patients vs none of 34), hearing loss (13 [38%] vs five [15%]), and tinnitus (12 [35%] vs two [6%]) reported in the radiotherapy group than in the TORS plus neck dissection group, and more cases of trismus in the TORS plus neck dissection group (nine [26%] vs one [3%]). The most common adverse events in the radiotherapy group were dysphagia (n=6), hearing loss (n=6), and mucositis (n=4), all grade 3, and in the TORS plus neck dissection group, dysphagia (n=9, all grade 3) and there was one death caused by bleeding after TORS. INTERPRETATION Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change. Toxicity patterns differed between the groups. Patients with OPSCC should be informed about both treatment options. FUNDING Canadian Cancer Society Research Institute Grant (#701842), Ontario Institute for Cancer Research Clinician-Scientist research grant, and the Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers grant.",2019,"INTERPRETATION Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change.","['Patients were enrolled at six hospitals in Canada and Australia', 'oropharyngeal squamous cell carcinoma (OPSCC', 'patients aged 18 years or older, with Eastern Cooperative Oncology Group scores of 0-2, and with T1-T2, N0-2 (≤4 cm) OPSCC tumour types to', '68 patients were randomly assigned (34 per group) between Aug 10, 2012, and June 9, 2017', 'Patients with OPSCC', 'oropharyngeal squamous cell carcinoma (ORATOR']","['radiotherapy (70 Gy, with chemotherapy if N1-2) or TORS plus neck dissection (with or without adjuvant chemoradiotherapy, based on pathology', 'Radiotherapy', 'radiotherapy', 'transoral robotic surgery and neck dissection', 'Transoral robotic surgery (TORS) with concurrent neck dissection']","['Toxicity patterns', 'dysphagia', 'hearing loss', 'superior swallowing-related QOL scores', 'neutropenia', 'swallowing-related QOL at 1 year as established using the MD Anderson Dysphagia Inventory (MDADI) score', 'cases of trismus', 'dysphagia (n=6), hearing loss (n=6), and mucositis', 'quality of life (QOL', 'MDADI total scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0280313', 'cui_str': 'Cancer of oropharynx, squamous cell'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Radiochemotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",68.0,0.207144,"INTERPRETATION Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change.","[{'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada. Electronic address: anthony.nichols@lhsc.on.ca.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Theurer', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Prisman', 'Affiliation': 'Department of Otolaryngology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berthelet', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'de Almeida', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': 'Department of Radiation Oncology, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Goldstein', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hier', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Sultanem', 'Affiliation': 'Department of Radiation Oncology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Richardson', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mlynarek', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Suren', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'S Danielle', 'Initials': 'SD', 'LastName': 'MacNeil', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winquist', 'Affiliation': 'Department of Medical Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'J Alex', 'Initials': 'JA', 'LastName': 'Hammond', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Varagur', 'Initials': 'V', 'LastName': 'Venkatesan', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kuruvilla', 'Affiliation': 'Department of Medical Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Corsten', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Johnson-Obaseki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'Department of Radiation Oncology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Odell', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Department of Audiology, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Wehrli', 'Affiliation': 'Department of Pathology, Western University, London, ON, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Kwan', 'Affiliation': 'Department of Pathology, Western University, London, ON, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30410-3'] 1670,31805396,Nocturnal bilevel positive airway pressure for the treatment of asthma.,"Nocturnal worsening of asthma may be due to reduced lung volumes and fewer sigh breaths, which have been shown to increase airway resistance and bronchoreactivity. We hypothesized that mimicking deep inspiration using nocturnal mechanical support would improve symptoms in patients with asthma. Subjects with asthma underwent usual care and bilevel positive airway pressure (PAP) therapy for 4 weeks, separated by 4 weeks, and methacholine challenge (PC 20 ) and subjective assessments. 13 patients with asthma alone and 8 with asthma + OSA completed the protocol. Change in bronchoreactivity (ratio of Post/Pre PC 20 ) was not significantly different during usual care and bilevel PAP [0.86 (IQR 0.19, 1.82) vs 0.94 (IQR 0.56, 2.5), p = 0.88], nor was the change in Asthma Control Test different: 0.1 ± 2.2 vs. -0.2 ± 2.9, p = 0.79, respectively. Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.",2020,"Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.","['patients with asthma', 'Subjects with asthma underwent', '13 patients with asthma alone and 8 with asthma\u202f+\u202fOSA completed the protocol', 'asthma']","['usual care and bilevel positive airway pressure (PAP) therapy', 'Bilevel PAP therapy']","['Change in bronchoreactivity', 'Nocturnal bilevel positive airway pressure', 'subjective or objective measures of asthma severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity (regime/therapy)'}]",,0.0264125,"Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, San Diego, CA, United States. Electronic address: rowens@ucsd.edu.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Campana', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Foster', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Schomer', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, San Diego, CA, United States.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2019.103355'] 1671,32495521,Fall Prevention and Anti-Osteoporosis in Osteopenia Patients of 80 Years of Age and Older: A Randomized Controlled Study.,"To evaluate the effects of two fall-prevention and anti-osteoporotic protocols in elderly patients with osteopenia (OPA). METHODS The present randomized controlled study included patients with OPA (n =123). The age of these patients was ≥80 years old, with the mean age of 83.54 ± 2.99 years, and the male-to-female ratio was 2.97:1.00. Fall-prevention guidance was given to all patients. Patients in the experiment group (n = 62) orally received 600 mg/d of calcium carbonate, 0.5 μg/d of alfacalcidol, and 70 mg/week of alendronate, while patients in the control group (n = 61) orally received 600 mg/d of calcium carbonate and 0.5 μg/d of alfacalcidol for 18 months. The grip strength, gait speed, bone turnover markers, serum calcium, serum phosphorus, parathyroid hormone (PTH), and bone mineral density were measured, and the Timed Up and Go (TUG) test and the chair rising test (CRT) were performed. Falls, fragility fractures, medication compliance, and side effects of the drugs were recorded. RESULTS The serum levels of bone turnover markers (type I procollagen amino-terminal peptide [P1NP], type I collagen carboxyl terminal peptide [β-CTx], and osteocalcin [OC]) decreased, while the bone mineral density of the lumbar spine and bilateral femoral neck increased after treatment in the experiment group (P < 0.05, P < 0.01). The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01). After treatment, the proportion of patients with increased hip T scores in the experiment group (66.1%, 41/62) was significantly higher than the proportion (35.0%, 21/60) in the control group (P = 0.001). The incidence of fall decreased in both groups after treatment compared to that before treatment (54.8% vs 33.9% and 54.1% vs 36.7%, respectively; P < 0.05). The incidence of fragility fractures was lower in the experiment group than the control group (8.1% vs 20.0%, P = 0.057). During the intervention period, the incidence of fragility fractures in patients who did not fall (3.8%, 3/79) was significantly lower than that in patients who fell (32.6%, 14/43) (P = 0.000). The risk of fragility fractures was significantly lower in patients who did not fall compared to patients who fell (relative risk: 0.117, 95% confidence interval: 0.035-0.384). CONCLUSION The combination of alendronate sodium with alfacalcidol and calcium can significantly improve the bone mineral density of the lumbar spine and femoral neck. For older patients with OPA, subjectively paying attention to avoiding falls can significantly reduce the risk of fragility fractures.",2020,"The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01).","['older patients with OPA', 'Osteopenia Patients of 80\u2009Years of Age and Older', 'The age of these patients was ≥80\u2009years old, with the mean age of 83.54 ±\u20092.99\u2009years, and the male-to-female ratio was 2.97:1.00', 'patients with OPA (n =123', 'elderly patients with osteopenia (OPA']","['calcium carbonate, 0.5 μg/d of alfacalcidol, and 70 mg/week of alendronate', 'calcium carbonate and 0.5 μg/d of alfacalcidol', 'fall-prevention and anti-osteoporotic protocols', 'alendronate sodium with alfacalcidol and calcium']","['risk of fragility fractures', 'serum levels of bone turnover markers (type I procollagen amino-terminal peptide', 'hip T scores', 'incidence of fragility fractures', 'rate of change in bone mineral density of the bilateral femoral neck', 'bone mineral density of the lumbar spine and bilateral femoral neck', 'grip strength, gait speed, bone turnover markers, serum calcium, serum phosphorus, parathyroid hormone (PTH), and bone mineral density', 'Timed Up and Go (TUG) test and the chair rising test (CRT', 'Falls, fragility fractures, medication compliance, and side effects', 'incidence of fall', 'bone mineral density of the lumbar spine and femoral neck', 'type I collagen carboxyl terminal peptide [β-CTx], and osteocalcin [OC']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0700482', 'cui_str': 'Alendronate sodium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}]",,0.0191453,"The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University Key Laboratory of Otolaryngology Head and Neck Surgery (Ministry of Education of China), Beijing institute of Otolaryngology, Beijing, China.'}, {'ForeName': 'Ming-Zhao', 'Initials': 'MZ', 'LastName': 'Qin', 'Affiliation': 'Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jin-Ping', 'Initials': 'JP', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}]",Orthopaedic surgery,['10.1111/os.12701'] 1672,32495742,Simulation-Based Education for Staff Managing Aggression and Externalizing Behaviors in Children With Autism Spectrum Disorder in the Hospital Setting: Pilot and Feasibility Study Protocol for a Cluster Randomized Controlled Trial.,"BACKGROUND Children with autism spectrum disorder (ASD) frequently demonstrate aggression and externalizing behaviors in the acute care hospital environment. Pediatric acute care nursing staff are often not trained in managing aggression and, in particular, lack confidence in preventing and managing externalizing behaviors in children with ASD. High-fidelity simulation exercises will be used in this study to provide deliberate practice for acute care pediatric nursing staff in the management of aggressive and externalizing behaviors. OBJECTIVE The purpose of this study is to conduct a pilot and feasibility cluster randomized controlled trial (RCT) to evaluate the effectiveness of simulation-based education for staff in managing aggression and externalizing behaviors of children with ASD in the hospital setting. METHODS This study has a mixed design, with between-group and within-participant comparisons to explore the acceptability and feasibility of delivering a large-scale cluster RCT. The trial process, including recruitment, completion rates, contamination, and completion of outcome measures, will be assessed and reported as percentages. This study will assess the acceptability of the simulation-based training format for two scenarios involving an adolescent with autism, with or without intellectual disability, who displays aggressive and externalizing behaviors and the resulting change in confidence in managing clinical aggression. Two pediatric wards of similar size and patient complexity will be selected to participate in the study; they will be randomized to receive either simulation-based education plus web-based educational materials or the web-based educational materials only. Change in confidence will be assessed using pre- and posttraining surveys for bedside nursing staff exposed to the training and the control group who will receive the web-based training materials. Knowledge retention 3 months posttraining, as well as continued confidence and exposure to clinical aggression, will be assessed via surveys. Changes in confidence and competence will be compared statistically with the chi-square test using before-and-after data to compare the proportion of those who have high confidence between the two arms at baseline and at follow-up. The simulation-based education will be recorded with trained assessors reviewing participants' abilities to de-escalate aggressive behaviors using a validated tool. This data will be analyzed using mean values and SDs to understand the variation in performance of individuals who undertake the training. Data from each participating ward will be collected during each shift for the duration of the study to assess the number of aggressive incidents and successful de-escalation for patients with ASD. Total change in Code Grey activations will also be assessed, with both datasets analyzed using descriptive statistics. RESULTS This study gained ethical approval from The Royal Children's Hospital Melbourne Human Research Ethics Committee (HREC) on November 1, 2019 (HREC reference number: 56684). Data collection was completed in February 2020. Data analysis is due to commence with results anticipated by August 2020. CONCLUSIONS We hypothesize that this study is feasible to be conducted as a cluster RCT and that simulation-based training will be acceptable for acute care pediatric nurses. We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000139976; http://www.ANZCTR.org.au/ACTRN12620000139976.aspx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/18105.",2020,"We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining. ","['children with ASD', 'patients with ASD', 'Children With Autism', 'adolescent with autism, with or without intellectual disability, who displays aggressive and externalizing behaviors and the resulting change in confidence in managing clinical aggression', 'Children with autism spectrum disorder (ASD', 'children with ASD in the hospital setting']","['simulation-based education plus web-based educational materials or the web-based educational materials only', 'simulation-based education for staff']",['Total change in Code Grey activations'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C1269776', 'cui_str': 'Gray color'}]",,0.196978,"We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining. ","[{'ForeName': 'Marijke Jane', 'Initials': 'MJ', 'LastName': 'Mitchell', 'Affiliation': ""Department of Neurodevelopment and Disability, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Fiona Helen', 'Initials': 'FH', 'LastName': 'Newall', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sokol', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Katrina Jane', 'Initials': 'KJ', 'LastName': 'Williams', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, Australia.'}]",JMIR research protocols,['10.2196/18105'] 1673,31937856,Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,"Vitamin D deficiency may contribute to etiology of type 2 diabetes in Asian Indians. The objectives of this study was to evaluate effect of vitamin D supplementation on glycemic profile and body composition in prediabetic and vitamin D deficient overweight/obese Asian Indian women. In this open-label randomized placebo-controlled trial (78 weeks duration), 121 females (aged 20-60 years) with prediabetes and vitamin D deficiency were randomly allocated in intervention (n, 61) and placebo (n, 60) groups. The primary outcome variables were fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia. In Intention-to-treat analysis, at the end of intervention, we observed significant decrease in FBG [-5.0 (-12.6-2.4), p = 0.04], 2-h blood glucose post OGTT [-11(-49.3-26.9), p = 0.02], hemoglobin A1c [-0.41 (5.89, 6.55), p = 0.05] and increase in 25(OH) D [7.5 (-6.0-20.9), p = 0.002] levels in intervention as compared to the placebo group. Changes in glycemic category based on FBG were as follows; intervention group: normal FBG, 58.6%; impaired fasting glucose (IFG), 39%; and type 2 diabetes mellitus (T2DM), 2.4%; placebo group: normal FBG, 48.8%; IFG, 46.3%; and T2DM, 4.9%. Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%. After intervention, subscapular skinfold (visit I st compared to visit III rd ) and suprailiac skinfold (visit II nd compared to visit III rd ) were significantly lower in intervention group vs. control group. In conclusion, we observed significant reduction in FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia in overweight/obese prediabetic vitamin D deficient Asian Indian women after 78 weeks of vitamin D supplementation.",2020,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","['prediabetic and vitamin D deficient overweight/obese Asian Indian women', 'Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat', '121 females (aged 20-60 years) with prediabetes and vitamin D deficiency']","['Placebo', 'Vitamin D deficiency', 'vitamin D supplementation', 'Vitamin D Supplementation', 'placebo']","['FBG', 'fasting glucose (IFG', 'subscapular skinfold (visit I st compared to visit III rd ) and suprailiac skinfold', 'normal glucose tolerance', 'hemoglobin A1c', 'glycemic category based on\xa0FBG', 'FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia', 'glycemic profile and body composition', 'fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia', '25(OH']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0943356,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-019-56904-y'] 1674,32441870,"Ripple Effects of a Community-Based Randomized Trial for Rural Women: Strong Hearts, Healthy Communities.","OBJECTIVE This study aimed to examine (1) whether the Strong Hearts, Healthy Communities intervention (SHHC) improved social network members' (SNMs') weight, exercise, and diet and (2) whether SNMs' weight and behavioral changes were modified by their relationship closeness and/or spatial closeness with trial participants. METHODS Eight towns received the SHHC intervention, which focused on building individual healthy behaviors and creating supportive social and built environments for exercise and healthy eating. Eight towns received an education-only control intervention. SNMs (n = 487) were recruited to complete a questionnaire at baseline and at 6 months that asked about demographics, weight, height, exercise, and eating habits. RESULTS SHHC's effect on SNMs differed depending on their relationship closeness with trial participants. Among SNMs who had a very close relationship with trial participants, those associated with the intervention group lost more weight and decreased BMI more than those associated with the control group (weight [kilograms] between-group difference: Δ = -1.68; 95% CI: -3.10 to -0.25; P = 0.021; BMI between-group difference: Δ = -0.60; 95% CI: -1.16 to -0.04; P = 0.034). Spatial closeness did not modify any of SHHC's ripple effects. CONCLUSIONS Relationship closeness, rather than spatial closeness, played an important role in influencing a rural community-based intervention's ripple effects.",2020,"Spatial closeness did not modify any of SHHC's ripple effects. ","['Rural Women: Strong Hearts, Healthy Communities', 'SNMs (n\xa0=\xa0487', 'Eight towns received the']","['SHHC intervention, which focused on building individual healthy behaviors and creating supportive social and built environments for exercise and healthy eating', ""Strong Hearts, Healthy Communities intervention (SHHC) improved social network members' (SNMs') weight, exercise, and diet and (2) whether SNMs' weight"", 'education-only control intervention']",['weight and decreased BMI'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4505382', 'cui_str': 'Built Environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}]",487.0,0.0803002,"Spatial closeness did not modify any of SHHC's ripple effects. ","[{'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Lo', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University, College Station, Texas, USA.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Donoso', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': 'Bassett Research Institute, Bassett Healthcare Network, Cooperstown, New York, USA.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Lynn C', 'Initials': 'LC', 'LastName': 'Paul', 'Affiliation': 'College of Education, Health and Human Development, Montana State University, Bozeman, Montana, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Cornell Statistical Consulting Unit, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University, College Station, Texas, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22817'] 1675,32139235,The Effect of Nursing Care Provided to Turkish Mothers of Infants Born With Cleft Lip and Palate on Maternal Attachment and Self-efficacy: A Quasi-Experimental Study.,"PURPOSE The present study evaluated the effect of the nursing care provided to the mothers of the infants born with a cleft lip and palate (CLP) until the time of cleft palate (CP) repair surgery, on maternal attachment and self-efficacy. DESIGN AND METHODS The present study was designed as a quasi-experimental study with a pre-test and post-test control group design. The study included 32 mothers whose infants were born with CLP and had undergone CL repair surgery. Nursing care was provided to the mothers and the infants included in the study group through a total of seven home visits over a period of nine weeks. The data for the study were collected using a socio-demographic form, a home-care needs evaluation form, the Maternal Attachment Inventory (MAI), and the Parental Self-Efficacy Scale (PSE). RESULTS The scores for the mothers in the intervention group increased as the visits progressed, and it was observed that by the end of the ninth week, the difference between the mothers in the intervention group and those in the control group in terms of post-test MAI and PSE had become statistically significant. CONCLUSIONS Providing nine weeks of home-based nursing care to the mothers and the infants has the potential of reducing the problems experienced by the mothers of infants born with CLP. PRACTICE IMPLICATIONS Obtaining a better understanding of the barriers to the nursing care provided to the mothers of the infants born with CLP in-home setting would contribute immensely to the development of appropriate nursing-care practices.",2020,"The scores for the mothers in the intervention group increased as the visits progressed, and it was observed that by the end of the ninth week, the difference between the mothers in the intervention group and those in the control group in terms of post-test MAI and PSE had become statistically significant. ","['Turkish mothers of infants born with cleft lip and palate on maternal attachment and self-efficacy', 'mothers of the infants born with a cleft lip and palate (CLP) until the time of cleft palate (CP) repair surgery, on maternal attachment and self-efficacy', '32 mothers whose infants were born with CLP and had undergone CL repair surgery']",['nursing care'],['Parental Self-Efficacy Scale (PSE'],"[{'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008924', 'cui_str': 'Harelip'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0028682', 'cui_str': 'Nursing Care'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}]",32.0,0.0224741,"The scores for the mothers in the intervention group increased as the visits progressed, and it was observed that by the end of the ninth week, the difference between the mothers in the intervention group and those in the control group in terms of post-test MAI and PSE had become statistically significant. ","[{'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Çınar', 'Affiliation': 'Pediatric Nursing Department, Faculty of Health Sciences, Artvin Çoruh University, Artvin, Turkey. Electronic address: cinarsevil87@gmail.com.'}, {'ForeName': 'Gulten', 'Initials': 'G', 'LastName': 'Koc', 'Affiliation': 'Faculty of Nursing, Department of Obstetrics and Gynecologic Nursing, Hacettepe University, Ankara, Turkey.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.02.032'] 1676,31427204,"Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial.","BACKGROUND In the ongoing phase 3 CheckMate 214 trial, nivolumab plus ipilimumab showed superior efficacy over sunitinib in patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma, with a manageable safety profile. In this study, we aimed to assess efficacy and safety after extended follow-up to inform the long-term clinical benefit of nivolumab plus ipilimumab versus sunitinib in this setting. METHODS In the phase 3, randomised, controlled CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to open-label nivolumab (3 mg/kg intravenously) plus ipilimumab (1 mg/kg intravenously) every 3 weeks for four doses, followed by nivolumab (3 mg/kg intravenously) every 2 weeks; or sunitinib (50 mg orally) once daily for 4 weeks (6-week cycle). Randomisation was done through an interactive voice response system, with a block size of four and stratified by risk status and geographical region. The co-primary endpoints for the trial were overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients. Secondary endpoints were overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events in all treated patients. In this Article, we report overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety after extended follow-up. Efficacy outcomes were assessed in all randomly assigned patients; safety was assessed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02231749, and is ongoing but now closed to recruitment. FINDINGS Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients were randomly assigned to nivolumab plus ipilimumab or sunitinib (550 vs 546 in the intention-to-treat population; 425 vs 422 intermediate-risk or poor-risk patients, and 125 vs 124 favourable-risk patients). With extended follow-up (median follow-up 32·4 months [IQR 13·4-36·3]), in intermediate-risk or poor-risk patients, results for the three co-primary efficacy endpoints showed that nivolumab plus ipilimumab continued to be superior to sunitinib in terms of overall survival (median not reached [95% CI 35·6-not estimable] vs 26·6 months [22·1-33·4]; hazard ratio [HR] 0·66 [95% CI 0·54-0·80], p<0·0001), progression-free survival (median 8·2 months [95% CI 6·9-10·0] vs 8·3 months [7·0-8·8]; HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001). Similarly, in intention-to-treat patients, nivolumab and ipilimumab showed improved efficacy compared with sunitinib in terms of overall survival (median not reached [95% CI not estimable] vs 37·9 months [32·2-not estimable]; HR 0·71 [95% CI 0·59-0·86], p=0·0003), progression-free survival (median 9·7 months [95% CI 8·1-11·1] vs 9·7 months [8·3-11·1]; HR 0·85 [95% CI 0·73-0·98], p=0·027), and the proportion of patients achieving an objective response (227 [41%] of 550 vs 186 [34%] of 546 p=0·015). In all treated patients, the most common grade 3-4 treatment-related adverse events in the nivolumab and ipilimumab group were increased lipase (57 [10%] of 547), increased amylase (31 [6%]), and increased alanine aminotransferase (28 [5%]), whereas in the sunitinib group they were hypertension (90 [17%] of 535), fatigue (51 [10%]), and palmar-plantar erythrodysaesthesia (49 [9%]). Eight deaths in the nivolumab plus ipilimumab group and four deaths in the sunitinib group were reported as treatment-related. INTERPRETATION The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories. FUNDING Bristol-Myers Squibb and ONO Pharmaceutical.",2019,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","['patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries', 'Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to', 'advanced renal cell carcinoma', 'patients with previously untreated advanced renal cell carcinoma across all risk categories', 'Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients', 'patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma']","['nivolumab plus ipilimumab or sunitinib', 'Nivolumab plus ipilimumab versus sunitinib', 'open-label nivolumab (3 mg/kg intravenously) plus ipilimumab', 'sunitinib', 'nivolumab plus ipilimumab']","['Efficacy outcomes', 'fatigue', 'alanine aminotransferase', 'overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients', 'overall survival', 'adverse events', 'increased amylase', 'progression-free survival', 'overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events', 'progression-free survival ', 'efficacy', 'efficacy and safety', 'hypertension', 'palmar-plantar erythrodysaesthesia', 'proportion of patients achieving an objective response', 'overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety', 'lipase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",1390.0,0.285576,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology and Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Arén Frontera', 'Affiliation': 'Department of Medical Oncology, Centro de Invetigación Clínica Bradford Hill, Santiago, Chile.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Salman', 'Affiliation': 'Department of Medical Oncology, Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Beuselinck', 'Affiliation': 'Department of Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Levine Cancer Institute, Atrium Healthcare, Charlotte, NC, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Neiman', 'Affiliation': 'Department of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel; Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Department of Oncology, Ospedale San Donato, Azienda USL Toscana Sud-Est, IstitutoToscanoTumori, Arezzo, Italy.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Department of Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Raya', 'Initials': 'R', 'LastName': 'Leibowitz-Amit', 'Affiliation': 'Oncology Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Sjoukje F', 'Initials': 'SF', 'LastName': 'Oosting', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redman', 'Affiliation': 'Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Department of Cancer Services: Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Service de Cancérologie Médicale Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pook', 'Affiliation': 'Department of Oncology, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Division of Medical Oncology, Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Mekan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30413-9'] 1677,31417322,Blood pressure lowering effects of a novel isometric exercise device following a 4-week isometric handgrip intervention.,"Background: Hypertension is the leading risk factor for global mortality. Isometric resistance exercise training reduces blood pressure (BP). However, the protocols used are often limited by cost/immobility and the use of rigid exercise modalities. In response, a novel more versatile, isometric exercise (IE) device, the IsoBall (IB) was created. Purpose: The aim of this study was to test the BP-lowering effectiveness of this prototype. Methods: Twenty-three healthy participants (29.10±2.19 years old, 173.95±3.83 cm, 75.43±5.06 kg, SBP 127.10±10.37 mmHg, DBP 70.40±6.77 mmHg) were randomly allocated to either a control group (CON) or 2 isometric handgrip (IHG) training groups that used the Zona plus (ZON) and IB devices. The intervention groups completed 3 sessions each week of 4, 2 min IHG at 30% maximal voluntary contraction, with a 1-min rest, for 4 weeks. Resting BP, heart rate (HR) and IHG strength were measured in all groups at baseline and postintervention. Results: Postintervention systolic BP (SBP) was significantly lower in both ZON (114.5±8.2 mmHg, p  = 0.000) and IB (119.9±7.0 mmHg, p  = 0.000) compared to control (131.0±12.4 mmHg). Postintervention diastolic BP (DBP) was reduced in both intervention groups (ZON 66.6±7.4 mmHg, p  = 0.004; IB 65.7±10.0 mmHg, p  = 0.012) compared to CON (71.1±8.8 mmHg). Mean arterial pressure (MAP) was reduced in both groups (ZON 82.6±6.8 mmHg, p  = 0.000; IB 84.3±9.1 mmHg, p  = 0.000) compared to control (91.0±9.7 mmHg). No significant changes were seen in HR or strength ( p > 0.05). Conclusion: The results of this study indicate that both the ZON and IB devices elicit significant SBP, DBP and MAP reductions. Despite the ZON group having larger reductions in BP, no significant differences were found between the two devices. Thus, this study indicates the IB device to be an effective alternative to the ZON that can also be used to perform other IE modalities.",2019,"Postintervention diastolic BP (DBP) was reduced in both intervention groups (ZON 66.6±7.4 mmHg, p  = 0.004; IB 65.7±10.0 mmHg, p  = 0.012) compared to CON (71.1±8.8 mmHg).","['Methods: Twenty-three healthy participants (29.10±2.19 years old, 173.95±3.83 cm, 75.43±5.06 kg, SBP 127.10±10.37 mmHg, DBP 70.40±6.77']","['novel isometric exercise device', 'ZON', 'control group (CON) or 2 isometric handgrip (IHG) training groups that used the Zona plus (ZON) and IB devices', 'Isometric resistance exercise training']","['Mean arterial pressure (MAP', 'Postintervention systolic BP (SBP', 'HR or strength', 'SBP, DBP and MAP reductions', 'Resting BP, heart rate (HR) and IHG strength', 'Postintervention diastolic BP (DBP', 'blood pressure (BP']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",23.0,0.0242792,"Postintervention diastolic BP (DBP) was reduced in both intervention groups (ZON 66.6±7.4 mmHg, p  = 0.004; IB 65.7±10.0 mmHg, p  = 0.012) compared to CON (71.1±8.8 mmHg).","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Baddeley-White', 'Affiliation': 'Department of Life & Sport Sciences, University of Greenwich, Medway Campus, London, UK.'}, {'ForeName': 'Cheri L', 'Initials': 'CL', 'LastName': 'McGowan', 'Affiliation': 'Department of Kinesiology, Faculty of Human Kinetics, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Howden', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte, Charlotte, NC, USA.'}, {'ForeName': 'Benjamin Dh', 'Initials': 'BD', 'LastName': 'Gordon', 'Affiliation': 'Department of Exercise and Rehabilitative Sciences, Slippery Rock University, Slippery Rock, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kyberd', 'Affiliation': 'Department of Engineering Science, University of Greenwich, Medway Campus, London, UK.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': 'Department of Life & Sport Sciences, University of Greenwich, Medway Campus, London, UK.'}]",Open access journal of sports medicine,['10.2147/OAJSM.S193008'] 1678,31416769,"Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study.","BACKGROUND Idiopathic interstitial pneumonias are often complicated by pulmonary hypertension, increasing morbidity and mortality. There are no approved treatments for pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP). We aimed to evaluate the efficacy and safety of riociguat in patients with PH-IIP. METHODS RISE-IIP was a double-blind, randomised, placebo-controlled study done at 65 pulmonary hypertension and interstitial lung disease centres in 19 countries to evaluate the efficacy and safety of riociguat in patients with PH-IIP. Eligible patients were adults (aged 18-80 years) diagnosed with idiopathic interstitial pneumonia (as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines), forced vital capacity (FVC) of at least 45%, 6MWD of 150-450 m, WHO functional classes II-IV, precapillary pulmonary hypertension confirmed by right heart catheterisation, systolic blood pressure of at least 95 mm Hg, and no signs or symptoms of hypotension. Patients were randomly allocated (1:1) using an interactive voice and web response system to riociguat (0·5-2·5 mg three times daily) or placebo for 26 weeks (main study), after which they could enter an open-label extension in which all patients received riociguat. The primary endpoint was change in 6-min walking distance (6MWD) in the intention-to-treat population. Prespecified safety variables included adverse events and serious adverse events, laboratory parameters, and adverse events of special interest (haemoptysis and symptomatic hypotension), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02138825. FINDINGS Between June 4, 2014, and May 5, 2016, we enrolled 229 participants. After the exclusion of 82 participants, 147 were randomly allocated to treatment (73 to riociguat, 74 to placebo). The study was terminated early (median treatment duration 157 days [range 6-203]) at the request of the data monitoring committee owing to increased serious adverse events (main study: 27 [37%] of 73 participants in the riociguat group vs 17 [23%] of 74 in the placebo group) and mortality in patients receiving riociguat, and the absence of efficacy signals in the riociguat group. 11 patients died in the main study (eight in the riociguat group, three in the placebo group), and nine died in the extension phase (one in the riociguat group, eight in the former placebo group; all received riociguat). In the main study, the most common adverse events were peripheral oedema (16 [22%] of 73 in the riociguat group vs seven [9%] of 74 in the placebo group) and diarrhoea (11 [15%] vs seven [9%]). The most common serious adverse events were worsening of interstitial lung disease (main study: six [8%] of 73 in the riociguat group vs five [7%] of 74 in the placebo group) and pneumonia (four [5%] vs one [1%]). Riociguat did not improve 6MWD versus placebo at 26 weeks (least-squares mean difference 21 m; 95% CI -9 to 52). INTERPRETATION In patients with PH-IIP, riociguat was associated with increased serious adverse events and mortality, and an unfavourable risk-benefit profile. Riociguat should not be used in patients with PH-IIP. FUNDING Bayer AG and Merck & Co.",2019,"Riociguat did not improve 6MWD versus placebo at 26 weeks (least-squares mean difference 21 m; 95% CI -9 to 52). ","['Between June 4, 2014, and May 5, 2016', 'idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP', 'patients with PH-IIP', 'enrolled 229 participants', '65 pulmonary hypertension and interstitial lung disease centres in 19 countries', 'Eligible patients were adults (aged 18-80 years) diagnosed with idiopathic interstitial pneumonia (as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines), forced vital capacity (FVC) of at least 45%, 6MWD of 150-450 m, WHO functional classes II-IV, precapillary pulmonary hypertension confirmed by right heart catheterisation, systolic blood pressure of at least 95 mm Hg, and no signs or symptoms of hypotension']","['placebo', 'Riociguat', 'interactive voice and web response system to riociguat (0·5-2·5 mg three times daily) or placebo', 'riociguat']","['diarrhoea', 'adverse events and serious adverse events, laboratory parameters, and adverse events of special interest (haemoptysis and symptomatic hypotension), assessed in the intention-to-treat population', 'mortality', 'serious adverse events', '6MWD', 'pneumonia', 'efficacy and safety of riociguat', 'peripheral oedema', 'serious adverse events and mortality', '6-min walking distance (6MWD']","[{'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C3696954', 'cui_str': 'Precapillary pulmonary hypertension'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0019079', 'cui_str': 'Hemoptysis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",229.0,0.546608,"Riociguat did not improve 6MWD versus placebo at 26 weeks (least-squares mean difference 21 m; 95% CI -9 to 52). ","[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'The Advanced Lung Disease and Transplant Program, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA. Electronic address: steven.nathan@inova.org.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Behr', 'Affiliation': 'Department of Internal Medicine V, Ludwig Maximilians University of Munich, Munich, Germany; Asklepios Fachkliniken München-Gauting, German Center for Lung Research, Munich, Germany.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Collard', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Department of Respiratory Medicine, Louis Pradel Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Marius M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Clinic for Respiratory Medicine, Hannover Medical School, German Center for Lung Research, Hannover, Germany.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, NSW, Australia; University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Keogh', 'Affiliation': ""St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Leuchte', 'Affiliation': 'Department of Internal Medicine II, Neuwittelsbach Academic Hospital, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Mogulkoc', 'Affiliation': 'Pulmonology, Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Clinic of Pulmonology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Wim A', 'Initials': 'WA', 'LastName': 'Wuyts', 'Affiliation': 'Unit for Interstitial Lung Diseases, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Bayer HealthCare, Beijing, China.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Boateng', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NY, USA.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'Royal Brompton Hospital, London, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30250-4'] 1679,31415040,Relationship Gender Equality and Couples' Uptake of Oral Human Immunodeficiency Virus Self-Testing Kits Delivered by Pregnant Women in Kenya.,"BACKGROUND Higher gender equality is associated with many human immunodeficiency virus (HIV) preventive behaviors, including HIV testing. HIV self-testing is a relatively new testing technology that could assist with HIV prevention. However, there are no studies examining gender equality and HIV self-testing. We examined the associations between gender equality and couples' uptake of HIV self-testing among heterosexual couples expecting a child in central Kenya. METHODS This analysis used data from a HIV self-testing randomized intervention trial among pregnant women attending antenatal care and their male partners. The primary exposures were gender equality (measured by the male partner's attitudes toward intimate partner violence, and the woman's report on her household decision making power), and the primary outcome was couples' uptake of HIV self-testing. Generalized linear mixed models framework was used to account for site-level clustering. RESULTS In comparison to male partners reporting high acceptance of intimate partner violence, couples with male partners reporting medium acceptance (odds ratio, 2.36; 95% confidence interval, 0.99-5.63) or low acceptance (odds ratio, 2.50; 95% confidence interval, 1.20-5.21) were significantly more likely to use HIV self-testing. Gender equality measured by decision making power was not associated with couples' uptake of HIV self-testing. CONCLUSIONS This study is the first of its kind to examine the association between gender equality and couples' HIV self-testing. This holds important implications for HIV self-testing as we strive to achieve the United Nations Programme on HIV/acquired immune deficiency syndrome goal that 90% of individuals living with HIV should know their status.",2019,"In comparison to male partners reporting high acceptance of intimate partner violence, couples with male partners reporting medium acceptance (odds ratio, 2.36; 95% confidence interval, 0.99-5.63) or low acceptance (odds ratio, 2.50; 95% confidence interval, 1.20-5.21) were significantly more likely to use HIV self-testing.","['pregnant women attending antenatal care and their male partners', 'Pregnant Women in Kenya', 'heterosexual couples expecting a child in central Kenya']",['Oral Human Immunodeficiency Virus Self-Testing Kits'],"[""couples' uptake of HIV self-testing"", ""gender equality (measured by the male partner's attitudes toward intimate partner violence, and the woman's report on her household decision making power""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}]",,0.0350884,"In comparison to male partners reporting high acceptance of intimate partner violence, couples with male partners reporting medium acceptance (odds ratio, 2.36; 95% confidence interval, 0.99-5.63) or low acceptance (odds ratio, 2.50; 95% confidence interval, 1.20-5.21) were significantly more likely to use HIV self-testing.","[{'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Vrana-Diaz', 'Affiliation': 'From the Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Korte', 'Affiliation': 'From the Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Mulugeta', 'Initials': 'M', 'LastName': 'Gebregziabher', 'Affiliation': 'From the Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Richey', 'Affiliation': 'Section of Infectious Disease, Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Anbesaw', 'Initials': 'A', 'LastName': 'Selassie', 'Affiliation': 'From the Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sweat', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gichangi', 'Affiliation': 'Jhpiego, Ring Rd, Arlington block, Nairobi, Kenya.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001037'] 1680,32496604,Response of preterm infants with transient hypothyroxinaemia of prematurity to the thyrotropin-releasing hormone stimulation test is characterized by a delayed decrease in thyroid-stimulating hormone after the peak.,"OBJECTIVES We evaluated the response to the thyrotropin-releasing hormone (TRH) stimulation test in very low-birth weight (VLBW) infants to elucidate the aetiology of transient hypothyroxinaemia of prematurity (THOP). DESIGN AND METHODS We performed TRH stimulation tests on 43 VLBW infants. Subjects were divided into two groups; a THOP group (N = 11; basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a non-THOP group (N = 32; basal TSH < 15 mU/L and basal FT4 > 0.8 ng/dL). Basal FT4 and FT3 were measured before, and TSH (0, 30, 60, 90, 120 and 180 minutes) was measured after, the administration of TRH (7 µg/kg). We calculated the ratio of TSH 180 minutes to THS 0 minute as the primary outcome. We also collected data on T3 and rT3 in this study. RESULTS In both groups, TSH 30 minutes values were the highest. However, the ratios of TSH 180 minutes to THS 0 minutes in the non-THOP group and the THOP group were (median [IQR]) 1.3 [1.0-1.7] and 3.0 [1.5-5.3] (P < .01). No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, P = .06). However, in the THOP group, rT3 was significantly lower than that of the non-THOP group (168.0 [148.1-197.0] and 92.9 [74.7-101.6] pg/mL, P < .01). CONCLUSIONS The delayed decrease in the TSH concentration after the peak for the TRH tests and decreased levels of rT3 suggest that the main aetiology for THOP is suppression at the level of the hypothalamus, but not inactivation of peripheral thyroid hormone metabolism.",2020,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","['preterm infants with transient hypothyroxinemia of prematurity', 'very low birth weight (VLBW) infants', '43 VLBW infants']","['basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a Non-THOP group (N=32; basal TSH', 'THOP', 'thyrotropin-releasing hormone (TRH) stimulation test', 'basal FT4']","['Basal FT4 and FT3', 'rT3', 'TSH concentration']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0439342', 'cui_str': 'mU/L'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040162', 'cui_str': 'Thyrotropin-Releasing Hormone'}, {'cui': 'C0201780', 'cui_str': 'Stimulation test'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.0682753,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kogoro', 'Initials': 'K', 'LastName': 'Iwanaga', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukura', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Fusako', 'Initials': 'F', 'LastName': 'Niwa', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Takita', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Clinical endocrinology,['10.1111/cen.14260'] 1681,32007138,"Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAF V600 -mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial.","BACKGROUND Adjuvant dabrafenib plus trametinib reduced the risk of relapse versus placebo in patients with resected, BRAF V600 -mutant, stage III melanoma in the phase 3 COMBI-AD trial. This prespecified exploratory biomarker analysis aimed to evaluate potential prognostic or predictive factors and mechanisms of resistance to adjuvant targeted therapy. METHODS COMBI-AD is a randomised, double-blind, placebo-controlled, phase 3 trial comparing dabrafenib 150 mg orally twice daily plus trametinib 2 mg orally once daily versus two matched placebos. Study participants were at least 18 years of age and underwent complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma, per American Joint Committee on Cancer 7th edition criteria, with a BRAF V600E or BRAF V600K mutation. Patients were randomly assigned (1:1) to the two treatment groups by an interactive voice response system, stratified by mutation type and disease stage. Patients, physicians, and the investigators who analysed data were masked to treatment allocation. The primary outcome was relapse-free survival, defined as the time from randomisation to disease recurrence or death from any cause. Biomarker assessment was a prespecified exploratory outcome of the trial. We assessed intrinsic tumour genomic features by use of next-generation DNA sequencing and characteristics of the tumour microenvironment by use of a NanoString RNA assay, which might provide prognostic and predictive information. This trial is registered with ClinicalTrials.gov, number NCT01682083, and is ongoing but no longer recruiting participants. FINDINGS Between Jan 31, 2013, and Dec 11, 2014, 870 patients were enrolled in the trial. Median follow-up at data cutoff (April 30, 2018) was 44 months (IQR 38-49) in the dabrafenib plus trametinib group and 42 months (21-49) in the placebo group. Intrinsic tumour genomic features were assessed in 368 patients (DNA sequencing set) and tumour microenvironment characteristics were assessed in 507 patients (NanoString biomarker set). MAPK pathway genomic alterations at baseline did not affect treatment benefit or clinical outcome. An IFNγ gene expression signature higher than the median was prognostic for prolonged relapse-free survival in both treatment groups. Tumour mutational burden was independently prognostic for relapse-free survival in the placebo group (high TMB, top third; hazard ratio [HR] 0·56, 95% CI 0·37-0·85, p=0·0056), but not in the dabrafenib plus trametinib group (0·83, 95% CI 0·53-1·32, p=0·44). Patients with tumour mutational burden in the lower two terciles seem to derive a substantial long-term relapse-free survival benefit from targeted therapy (HR [versus placebo] 0·49, 95% CI 0·35-0·68, p<0·0001). However, patients with high tumour mutational burden seem to have a less pronounced benefit with targeted therapy (HR [versus placebo] 0·75, 95% CI 0·44-1·26, p=0·27), especially if they had an IFNγ signature lower than the median (HR 0·88 [95% CI 0·40-1·93], p=0·74). INTERPRETATION Tumour mutational burden alone or in combination with IFNγ gene expression signature or other markers for an adaptive immune response might be of relevance for identifying patients with stage III melanoma who might derive clinical benefit from targeted therapy. Further validation in prospective clinical trials is warranted. FUNDING Novartis Pharmaceuticals.",2020,"Tumour mutational burden was independently prognostic for relapse-free survival in the placebo group (high TMB, top third; hazard ratio [HR] 0·56, 95% CI 0·37-0·85, p=0·0056), but not in the dabrafenib plus trametinib group (0·83, 95% CI 0·53-1·32, p=0·44).","['368 patients (DNA sequencing set) and tumour microenvironment characteristics were assessed in 507 patients (NanoString biomarker set', 'Study participants were at least 18 years of age and underwent complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma, per American Joint Committee on Cancer 7th edition criteria, with a BRAF V600E or BRAF V600K mutation', 'patients with stage III melanoma', 'patients with resected, BRAF V600 -mutant, stage III melanoma (COMBI-AD', 'patients with resected, BRAF V600 -mutant, stage III melanoma in the phase 3 COMBI-AD trial', 'Between Jan 31, 2013, and Dec 11, 2014, 870 patients were enrolled in the trial', '0·49']","['placebo', 'Adjuvant dabrafenib plus trametinib versus placebo', 'dabrafenib 150 mg orally twice daily plus trametinib 2 mg orally once daily versus two matched placebos']","['risk of relapse', 'relapse-free survival', 'substantial long-term relapse-free survival benefit', 'relapse-free survival, defined as the time from randomisation to disease recurrence or death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917792', 'cui_str': 'DNA Sequencing'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C3644516', 'cui_str': 'trametinib 2 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",870.0,0.798016,"Tumour mutational burden was independently prognostic for relapse-free survival in the placebo group (high TMB, top third; hazard ratio [HR] 0·56, 95% CI 0·37-0·85, p=0·0056), but not in the dabrafenib plus trametinib group (0·83, 95% CI 0·53-1·32, p=0·44).","[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zürich, Switzerland. Electronic address: reinhard.dummer@usz.ch.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garrett', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Catarina D', 'Initials': 'CD', 'LastName': 'Campbell', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Squires', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gusenleitner', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Macquarie University and Westmead Hospital, Sydney, NSW, Australia; Melanoma Institute Australia and The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia and The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30062-0'] 1682,31557061,A Mechanism Study of Electroacupuncture for Dry Eye Syndrome by Targeting Conjunctival Cytokine Expressions.,"Aim : To discuss the immunological mechanism in electroacupuncture (EA) treatment of dry eye syndrome (DES) by targeting the changes in conjunctival cytokine expression profile. Method : Eligible DES patients were randomized into an EA group (EAG) or an acupuncture group (AG). The ocular surface disease index (OSDI), amount of tear production, and tear film break-up time (BUT) were observed to evaluate the efficacy. Conjunctival cells were collected from both effective and invalid cases to observe the expressions of cytokines by protein microarray. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) were used for functional cluster and signaling pathway analysis of the differentially expressed proteins. Enzyme-linked immunosorbent assay (ELISA) was used to verify the specific differential proteins. Result : After treatment, OSDI dropped and BUT extended in both groups, and the tear production increased only in the EAG (all P < .01). Compared with the AG, the improvement in tear production was more significant in the EAG ( P < .01). There were 17 differentially expressed conjunctival cytokines between the effective and invalid cases in the EAG, and those expressed higher than the limit of detection (LOD) included monocyte chemoattractant protein 1 (MCP-1), macrophage colony-stimulating factor (M-CSF), regulated on activation in normal T-cell expressed and secreted (RANTES) and tissue inhibitor of metalloproteinases 1 (TIMP-1). GO analysis showed that the differential cytokines were mainly involved in cellular interaction, signaling pathways and reactions to stimuli. KEGG analysis revealed that the signaling pathways of these cytokines were mainly responsible for interactions between cytokines or between cytokines and their receptors, such as Jak-STAT signaling pathway, chemokine signaling pathway, and tumor necrosis factor signaling pathway. Conclusion : EA can effectively treat DES by improving the symptoms, increasing tear secretion and extending BUT, which is possibly related to its regulation on the conjunctival cytokine expressions.",2020,"Compared with the AG, the improvement in tear production was more significant in the EAG ( P < .01).","['Method : Eligible DES patients', 'dry eye syndrome (DES']","['electroacupuncture (EA', 'EA group (EAG) or an acupuncture', 'EA', 'Electroacupuncture', 'Enzyme-linked immunosorbent assay (ELISA']","['Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG', 'OSDI dropped and BUT', 'conjunctival cytokines', 'limit of detection (LOD) included monocyte chemoattractant protein 1 (MCP-1), macrophage colony-stimulating factor (M-CSF), regulated on activation in normal T-cell expressed and secreted (RANTES) and tissue inhibitor of metalloproteinases 1 (TIMP-1', 'ocular surface disease index (OSDI), amount of tear production, and tear film break-up time (BUT', 'Conjunctival cells', 'tear production']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Syndromes'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}]","[{'cui': 'C1138831', 'cui_str': 'Gene Ontology'}, {'cui': 'C0014095', 'cui_str': 'Encyclopedias'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C2718050', 'cui_str': 'Limit of Detection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079784', 'cui_str': 'CSF-1'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0145947', 'cui_str': 'TIMP-1'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2363241', 'cui_str': 'Tear production, function (observable entity)'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time (observable entity)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",17.0,0.0134036,"Compared with the AG, the improvement in tear production was more significant in the EAG ( P < .01).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Acupuncture-moxibustion and Immunology, Shanghai Research Institute of Acupuncture and Meridian, Xuhui, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture-moxibustion, Tuina and Rehabilitation, Yunnan University of Traditional Chinese Medicine, Chenggong, Kunming, Yunnan, China.'}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Acupuncture-moxibustion and Immunology, Shanghai Research Institute of Acupuncture and Meridian, Xuhui, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Acupuncture-moxibustion and Immunology, Shanghai Research Institute of Acupuncture and Meridian, Xuhui, Shanghai, China.'}, {'ForeName': 'Dan-Yan', 'Initials': 'DY', 'LastName': 'Wu', 'Affiliation': 'Yueyang Clinical Medical College, Shanghai University of Traditional Chinese Medicine, Hongkou, Shanghai, China.'}, {'ForeName': 'Xiao-Xu', 'Initials': 'XX', 'LastName': 'Liu', 'Affiliation': 'Yueyang Clinical Medical College, Shanghai University of Traditional Chinese Medicine, Hongkou, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Key Laboratory of Acupuncture-moxibustion and Immunology, Shanghai Research Institute of Acupuncture and Meridian, Xuhui, Shanghai, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Key Laboratory of Acupuncture-moxibustion and Immunology, Shanghai Research Institute of Acupuncture and Meridian, Xuhui, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Acupuncture-moxibustion and Immunology, Shanghai Research Institute of Acupuncture and Meridian, Xuhui, Shanghai, China.'}, {'ForeName': 'Xiao-Peng', 'Initials': 'XP', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Acupuncture-moxibustion and Immunology, Shanghai Research Institute of Acupuncture and Meridian, Xuhui, Shanghai, China.'}]",Current eye research,['10.1080/02713683.2019.1666997'] 1683,30477032,Does Time of Wound Complication after Cesarean Delivery Differ by Type of Skin Closure?,"OBJECTIVE A high proportion of postcesarean wound complications occur after patients have been discharged from the hospital, increasing personal and health care costs. We undertook this study to evaluate the association between skin closure methods (suture vs. staple) following a cesarean delivery and the frequency of wound complications occurring after hospital discharge. STUDY DESIGN This is a secondary analysis of data from a randomized trial in which women undergoing cesarean delivery at ≥24 weeks' gestation were randomized to receive metallic staples or subcuticular suture for skin closure after surgery. Staples were removed at the time of hospital discharge on postoperative days 3 to 4 for Pfannenstiel incisions or days 7 to 10 for vertical. The primary outcome for this analysis was any wound complication occurring after hospital discharge. Wound complications were infections or any wound disruption without infection (including seromas and hematomas). Associations were examined using chi-square and Fisher's exact tests, as appropriate, and multivariable logistic regression. RESULTS A total of 350 patients with follow-up through 4 to 6 weeks postpartum were included in the analysis: n  = 171 received suture closure and n  = 179 received staples. In the primary trial, wound complications occurred in 14.5% ( n  = 26) of individuals with staples and 5.9% ( n  = 10) with sutures ( p  = 0.008). Twenty-one (58.3%) of the 36 wound complications occurred after hospital discharge. The incidence of wound complications occurring after hospital discharge was 6.7% ( n  = 12) of patients receiving staples and 5.3% ( n  = 9) of those receiving sutures; p  = 0.57; relative risk [95% confidence interval]: 1.27 [0.55-2.95]). After multivariable adjustment, type of skin closure method was not associated with wound complication after discharge from the hospital (odds ratio: 1.29; 0.52-3.17). CONCLUSION Although suture closure compared with staples was associated with fewer wound complications after cesarean delivery, we found no significant differences between closure types in the frequency of wound complications occurring after hospital discharge.",2019,"In the primary trial, wound complications occurred in 14.5% ( n  = 26) of individuals with staples and 5.9% ( n  = 10) with sutures ( p  = 0.008).","[""women undergoing cesarean delivery at ≥24 weeks' gestation"", '350 patients with follow-up through 4 to 6 weeks postpartum were included in the analysis: n \u2009=\u2009171 received']","['metallic staples or subcuticular suture for skin closure after surgery', 'suture closure and n \u2009=\u2009179 received staples', 'skin closure methods (suture vs. staple']","['incidence of wound complications occurring after hospital discharge', 'wound complication', 'frequency of wound complications', 'wound complication occurring after hospital discharge', 'wound complications']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1096106'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",350.0,0.368154,"In the primary trial, wound complications occurred in 14.5% ( n  = 26) of individuals with staples and 5.9% ( n  = 10) with sutures ( p  = 0.008).","[{'ForeName': 'Shontreal M', 'Initials': 'SM', 'LastName': 'Cooper', 'Affiliation': 'Department of Obstetrics and Gynecology, Drexel College of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christina T', 'Initials': 'CT', 'LastName': 'Blanchard', 'Affiliation': 'Department of Biostatistics, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Jeffery M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': 'Department of Biostatistics, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama School of Medicine, Birmingham, Alabama.'}]",American journal of perinatology,['10.1055/s-0038-1675767'] 1684,32163431,Preliminary Efficacy of a Cognitive Behavioral Therapy Text Messaging Intervention Targeting Alcohol Use and Antiretroviral Therapy Adherence: A Randomized Clinical Trial.,"TRIAL REGISTRATION This trial was registered with ClinicalTrials.gov, NCT02603471.",2020,"This trial was registered with ClinicalTrials.gov, NCT02603471.",[],['Cognitive Behavioral Therapy Text Messaging Intervention Targeting Alcohol Use and Antiretroviral Therapy Adherence'],[],[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],,0.399739,"This trial was registered with ClinicalTrials.gov, NCT02603471.","[{'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Chokron Garneau', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ang', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rawson', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Mansfield, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0229557'] 1685,32493441,Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome. TRIAL DESIGN A phase 3 prospective, multi-center, interventional, open label, 6-arm 2x2 factorial design study. PARTICIPANTS Subjects will be recruited at the specialized COVID-19 wards and/or ICUs at 16 Belgian participating hospitals. Only adult (≥18y old) patients will be recruited with recent (≤16 days) COVID-19 infection and acute hypoxia (defined as PaO2/FiO2 below 350mmHg or PaO2/FiO2 below 280 on supplemental oxygen and immediately requiring high flow oxygen device or mechanical ventilation) and signs of systemic cytokine release syndrome characterized by high serum ferritin, or high D-dimers, or high LDH or deep lymphopenia or a combination of those, who have not been on mechanical ventilation for more than 24 hours before randomisation. Patients should have had a chest X-ray and/or CT scan showing bilateral infiltrates within the last 2 days before randomisation. Patients with active bacterial or fungal infection will be excluded. INTERVENTION AND COMPARATOR Patients will be randomized to 1 of 5 experimental arms versus usual care. The experimental arms consist of Anakinra alone (anti-IL-1 binding the IL-1 receptor), Siltuximab alone (anti-IL-6 chimeric antibody), a combination of Siltuximab and Anakinra, Tocilizumab alone (humanised anti-IL-6 receptor antibody) or a combination of Anakinra with Tocilizumab in addition to standard care. Patients treated with Anakinra will receive a daily subcutaneous injection of 100mg for a maximum of 28 days or until hospital discharge, whichever comes first. Siltuximab (11mg/kg) or Tocilizumab (8mg/kg, with a maximum dose of 800mg) are administered as a single intravenous injection immediately after randomization. MAIN OUTCOMES The primary end point is the time to clinical improvement defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death. This ordinal scale is composed of (1) Death; (2) Hospitalized, on invasive mechanical ventilation or ECMO; (3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, not requiring supplemental oxygen; (6) Not hospitalized. RANDOMISATION Patients will be randomized using an Interactive Web Response System (REDCap). A 2x2 factorial design was selected with a 2:1 randomization regarding the IL-1 blockade (Anakinra) and a 1:2 randomization regarding the IL-6 blockade (Siltuximab and Tocilizumab). BLINDING (MASKING) In this open-label trial neither participants, caregivers, nor those assessing the outcomes are blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive Siltuximab alone, 76 patients will receive Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab. TRIAL STATUS COV-AID protocol version 3.0 (15 Apr 2020). Participant recruitment is ongoing and started on April 4 th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment. TRIAL REGISTRATION The trial was registered on Clinical Trials.gov on April 1st, 2020 (ClinicalTrials.gov Identifier: NCT04330638) and on EudraCT on April 3rd 2020 (Identifier: 2020-001500-41). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients with active bacterial or fungal infection will be excluded', 'severely ill COVID-19 patients with anti-interleukin drugs (COV-AID', '342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive', '3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, not requiring supplemental oxygen; (6) Not hospitalized', 'on April 3rd 2020 (Identifier: 2020-001500-41', 'Only adult (≥18y old) patients will be recruited with recent (≤16 days', 'patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome', 'Subjects will be recruited at the specialized COVID-19 wards and/or ICUs at 16 Belgian participating hospitals']","['Interactive Web Response System (REDCap', 'Siltuximab alone', 'EudraCT', 'Anakinra alone (anti-IL-1 binding the IL-1 receptor), Siltuximab alone (anti-IL-6 chimeric antibody), a combination of Siltuximab and Anakinra, Tocilizumab alone (humanised anti-IL-6 receptor antibody) or a combination of Anakinra with Tocilizumab', 'Tocilizumab', 'individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care', 'Siltuximab', 'invasive mechanical ventilation or ECMO', 'IL-6 blockade (Siltuximab and Tocilizumab', 'Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab']","['time to clinical improvement defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death', 'COVID-19 infection and acute hypoxia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1609931', 'cui_str': 'siltuximab'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",342.0,0.275166,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04453-5'] 1686,32224318,Perspectives on the model-based approach to proton therapy trials: A retrospective study of a lung cancer randomized trial.,"PURPOSE The goal of this study was to assess whether a model-based approach applied retrospectively to a completed randomized controlled trial (RCT) would have significantly altered the selection of patients of the original trial, using the same selection criteria and endpoint for testing the potential clinical benefit of protons compared to photons. METHODS AND MATERIALS A model-based approach, based on three widely used normal tissue complication probability (NTCP) models for radiation pneumonitis (RP), was applied retrospectively to a completed non-small cell lung cancer RCT (NCT00915005). It was assumed that patients were selected by the model-based approach if their expected ΔNTCP value was above a threshold of 5%. The endpoint chosen matched that of the original trial, the first occurrence of severe (grade ≥3) RP. RESULTS Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for lung cancer using RP as the normal tissue endpoint. The analyzed lung trial showed that less than 19% (32/165) of patients enrolled in the completed trial would have been enrolled in a model-based trial, prescribing photon therapy to all other patients. The number of patients enrolled was also found to be dependent on the type of NTCP model used for evaluating RP, with the three models enrolling 3%, 13% or 19% of patients. This result does show limitations in NTCP models which would affect the success of a model-based trial approach. No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. CONCLUSIONS Uncertainties in the outcome models to predict NTCP are the inherent drawback of a model-based approach to clinical trials. The impact of these uncertainties on enrollment in model-based trials depends on the predicted difference between the two treatment arms and on the set threshold for patient stratification. Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for specific treatment sites, such as lung cancer, depending on the chosen normal tissue endpoint.",2020,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. ",[],[],[],[],[],[],,0.0324994,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. ","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McNamara', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA. Electronic address: amcnamara2@mgh.harvard.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Shusharina', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ajdari', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Paganetti', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.022'] 1687,32501914,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population. METHODS Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications. RESULTS The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group. CONCLUSIONS There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients. LEVEL OF EVIDENCE Level I.",2020,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480'] 1688,32501613,The causal pathway effects of a physical activity intervention on adiposity in children: The KISS Study cluster randomized clinical trial.,"BACKGROUND Very little information on the potential mechanisms of the physical activity interventions effects on adiposity is available. We evaluated the possible mediating factors of a physical activity school-based intervention on the sum of skinfolds in children. METHODS This is a cluster randomized trial, secondary analysis of the KISS study. Children (n = 499) from the first and fifth grades were randomly assigned to intervention or control group. Adiposity was estimated by four skinfolds, aerobic fitness assessed by the shuttle run test, and insulin, triglycerides, total cholesterol, high-density lipoprotein (HDL), and glucose collected via fasting blood samples. RESULTS The intervention affected aerobic fitness (0.140 SD, 95% CI 0.011 to 0.270), triglycerides (0.217 SD, 95% CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95% CI -0.334 to -0.047), glucose (-0.330 SD, 95% CI -0.538 to -0.121), and skinfolds (-0.122 SD, 95% CI -0.189 to -0.056). No intervention effect on insulin was found. We observed that changes in aerobic fitness impacted children's triglycerides and cholesterol/HDL ratio and consecutively the glucose levels mediating 30% of the intervention effect on skinfolds. CONCLUSIONS Our findings provided evidence of the positive metabolic distress caused by a physical activity intervention on adiposity levels in children.",2020,"The intervention affected aerobic fitness (0.140 SD, 95%CI 0.011 to 0.270), triglycerides (0.217 SD, 95%CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95%CI -0.334 to -0.047), glucose (-0.330 SD, 95%CI -0.538 to -0.121) and skinfolds (-0.122 SD, 95%CI -0.189 to -0.056).","['Children (n=499) from the first and fifth grades', 'children']","['physical activity intervention', 'physical activity school-based intervention']","['aerobic fitness', 'aerobic fitness assessed by the shuttle run test, and insulin, triglycerides, total cholesterol, high-density lipoprotein (HDL) and glucose collected via fasting blood samples', 'Adiposity', 'triglycerides', 'adiposity levels', ""aerobic fitness impacted children's triglycerides and cholesterol/HDL ratio"", 'cholesterol/HDL ratio']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.117116,"The intervention affected aerobic fitness (0.140 SD, 95%CI 0.011 to 0.270), triglycerides (0.217 SD, 95%CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95%CI -0.334 to -0.047), glucose (-0.330 SD, 95%CI -0.538 to -0.121) and skinfolds (-0.122 SD, 95%CI -0.189 to -0.056).","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sports Science, University of Graz, Graz, Austria.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Susi', 'Initials': 'S', 'LastName': 'Kriemler', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13741'] 1689,32499503,Reconsolidation-based treatment for fear of public speaking: a systematic pilot study using propranolol.,"Pharmacological manipulation of memory reconsolidation opens up promising new avenues for anxiety disorder treatment. However, few studies have directly investigated reconsolidation-based approaches in subclinical or clinical populations, leaving optimal means of fear memory reactivation unknown. We conducted a systematic pilot study to assess whether a reconsolidation-based treatment could tackle public speaking anxiety in a subclinical sample (N = 60). As lab studies indicate that the duration of reactivation may be important for inducing reconsolidation, we investigated several speech lengths to help inform further translational efforts. Participants underwent a stress-inducing speech task composed of 3-min preparation, and from 0 to 9 min of public speaking, in 1-min increments. They then received either 40 mg of propranolol (n = 40) or placebo (n = 20), double-blind, allocated 4:2 for each speech duration. Participants performed a second speech 1 week post treatment, and were followed up with questionnaires 1- and 3 months later. Both self-reported speech distress and questionnaire measures of public speaking anxiety showed clear reductions following treatment. However, propranolol did not reliably outperform placebo, regardless of speech duration at treatment. Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test. These findings highlight the challenges facing the translation of laboratory research on memory reconsolidation into clinical interventions. Lack of explicit controls for factors beyond duration, such as 'prediction error', could explain these null findings, but positive results in clinical interventions are needed to demonstrate that taking such factors into account can deliver the promises of reconsolidation-based therapy.",2020,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"['fear of public speaking', 'tackle public speaking anxiety in a subclinical sample (N\u2009=\u200960']","['stress-inducing speech task composed of 3-min preparation, and from 0 to 9\u2009min of public speaking', 'propranolol', 'placebo']",['Physiological responses (heart rate and salivary cortisol'],"[{'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0293513,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"[{'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Elsey', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands. j.w.b.elsey@uva.nl.'}, {'ForeName': 'Anna I', 'Initials': 'AI', 'LastName': 'Filmer', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harriet R', 'Initials': 'HR', 'LastName': 'Galvin', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Kurath', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vossoughi', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linnea S', 'Initials': 'LS', 'LastName': 'Thomander', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zavodnik', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",Translational psychiatry,['10.1038/s41398-020-0857-z'] 1690,32502772,The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.,"OBJECTIVE To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS). DESIGN Single centre double blind randomised controlled trial. PARTICIPANTS Women aged 18 years or over who had a CS. INTERVENTIONS All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group). MAIN OUTCOME MEASURES The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate. RESULTS 324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups. CONCLUSIONS This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.",2020,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","['Women aged 18 years or over who had a CS', '324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group', 'surgical site infection following caesarean section']","['caesarean section (CS', 'copper impregnated wound dressings', 'copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group']","['SSI rates', 'infection rate', 'length of hospital stay, and readmission rate', 'incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire', 'surgical site infection (SSI) rate', 'Length of hospital stay, and readmission rate', 'incidence of superficial/deep SSI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",324.0,0.239103,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","[{'ForeName': 'Linda P', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Research Fellow, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: l.p.arendsen@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Consultant Obstetrician and Urogynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: ranee.thakar@nhs.net.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, Amersham, United Kingdom. Electronic address: paul@statsconsultancy.co.uk.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Consultant Obstetrician and UroGynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, Croydon, CR7 7YE, United Kingdom Honorary Reader, St George's University of London. Electronic address: abdulsultan@nhs.net.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.016'] 1691,32502775,"Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial.","STUDY OBJECTIVE Comparison of ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB) in patients undergoing total hip arthroplasty (THA). DESIGN Randomized equivalence trial. SETTING University Hospital. PATIENTS Sixty patients undergoing primary THA. INTERVENTIONS Patients were randomly allocated to receive ultrasound-guided LPB (n = 30) or SIFIB (n = 30). The local anesthetic agent (40 mL of levobupivacaine 0.25% with epinephrine 5 μg/mL) and block adjuvant (4 mg of intravenous dexamethasone) were identical in all subjects. Postoperatively, all patients received patient-controlled intravenous analgesia (morphine) as well as acetaminophen and ketoprofen during 48 h. MEASUREMENTS A blinded investigator recorded morphine consumption at 24 and 48 h as well as time to first morphine request, pain scores at 3, 6, 12, 24 and 48 h, incidence of adverse events, time to readiness for discharge, and length of hospital stay. The blinded investigator also carried out sensorimotor block assessment at 3, 6 and 24 h using a 10-point sensorimotor composite scale. MAIN RESULTS No intergroup differences were found in terms of cumulative morphine consumption at 24 h (95% CI: -4.0 mg to 2.0 mg) and 48 h (95% CI, -5.0 mg to 2.0 mg) or time to first morphine request. Furthermore, pain scores were similar at all time intervals after 3 h. There were no intergroup differences in terms of composite sensorimotor scores at 3 and 6 h. However, SIFIB lasted longer than lumbar plexus block as evidenced by a higher composite score at 24 h. No intergroup differences were found in terms of complications. Compared with LPB, SIFIB was associated with shorter time to readiness for discharge (3 [1-4] vs. 2 [1-3] days; P = 0.042) and length of hospital stay (3 [2-5] vs. 3 [2-4] days; P = 0.048). CONCLUSIONS For THA, no differences were found between LPB and SIFIB in terms of breakthrough morphine requirement and pain control. However, SIFIB resulted in a longer block and was associated with shorter time to readiness for discharge as well as decreased hospital stay.",2020,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"['Sixty patients undergoing primary THA', 'University Hospital', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['block adjuvant (4\xa0mg of intravenous dexamethasone', 'acetaminophen and ketoprofen', 'levobupivacaine', 'ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB', 'epinephrine', 'patient-controlled intravenous analgesia (morphine', 'ultrasound-guided LPB', 'Lumbar plexus block versus suprainguinal fascia iliaca block']","['shorter time to readiness for discharge', 'breakthrough morphine requirement and pain control', 'cumulative morphine consumption', 'length of hospital stay', 'complications', 'composite sensorimotor scores', 'adverse events, time to readiness for discharge, and length of hospital stay', 'hospital stay', 'Furthermore, pain scores', 'morphine consumption at 24 and 48\xa0h as well as time to first morphine request, pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",60.0,0.130543,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456. Electronic address: dbravoadvis@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Barrientos', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Wulf', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Montreal General Hospital, Department of Anesthesiology, McGill University, 1650 Ave Cedar, D10-D144, Montreal, Quebec H3G-1A4, Canada.'}, {'ForeName': 'De Q', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': ""St. Mary's Hospital, Department of Anesthesiology, McGill University, 3830 Ave Lacombe, Montreal, Quebec H3T-1M5, Canada.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109907'] 1692,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities. RESEARCH QUESTION Is underwater gait training or overground gait training more effective in severe stroke patients? METHODS A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training. RESULTS Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm). SIGNIFICANCE In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking. CLINICAL TRIAL REGISTRATION NUMBER KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022'] 1693,32503663,Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The hypothesis of the proposed intervention is that Granulocyte-macrophage colony-stimulating factor (GM-CSF) has profound effects on antiviral immunity, and can provide the stimulus to restore immune homeostasis in the lung with acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. Sargramostim is a man-made form of the naturally-occurring protein GM-CSF. TRIAL DESIGN A phase 4 academic, prospective, 2 arm (1:1 ratio), randomized, open-label, controlled trial. PARTICIPANTS Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen. Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels > 2000 μg/mL. INTERVENTION AND COMPARATOR Inhaled sargramostim 125 μg twice daily for 5 days in addition to standard care. Upon progression of disease requiring mechanical ventilation or to acute respiratory distress syndrome (ARDS) and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125 μg/m 2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment. Intervention will be compared to standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards in the standard of care group will have the option (clinician's decision) to initiate IV sargramostim 125m μg/m 2 body surface area once daily for 5 days. MAIN OUTCOMES The primary endpoint of this intervention is measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen). RANDOMISATION Patients will be randomized in a 1:1 ratio. Randomization will be done using REDCap (electronic IWRS system). BLINDING (MASKING) In this open-label trial neither participants, caregivers, nor those assessing the outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group. TRIAL STATUS SARPAC protocol Version 2.0 (April 15 2020). Participant recruitment is ongoing in 5 Belgian Hospitals (i.e. University Hospital Ghent, AZ Sint-Jan Bruges, AZ Delta Roeselare, University Hospital Brussels and ZNA Middelheim Antwerp). Participant recruitment started on March 26 th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment. TRIAL REGISTRATION The trial was registered on Clinical Trials.gov on March 30 th , 2020 (ClinicalTrials.gov Identifier: NCT04326920) - retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT on March 24th, 2020 (Identifier: 2020-001254-22). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a', 'on March 24th, 2020', 'Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels ', '2000', 'patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC', '80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group']","['https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT', 'Sargramostim', 'Inhaled sargramostim', 'PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen']","['measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2939461', 'cui_str': 'Myeloid neoplasm'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0216231', 'cui_str': 'sargramostim'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0232010', 'cui_str': 'Alveolar pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",80.0,0.333777,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04451-7'] 1694,32508211,The Influence of Evidence-Based Exercise and Age Reattribution on Physical Function in Hispanic Older Adults: Results From the ¡Caminemos! Randomized Controlled Trial.,"Older Hispanics routinely exhibit unhealthy beliefs about ""normal"" aging trajectories, particularly related to exercise and physical function. We evaluated the prospective effects of age reattribution on physical function in older Hispanics. Participants ( n = 565, ≥60 years) were randomly assigned into (a) treatment group-attribution-retraining, or (b) control group-health education. Each group separately engaged in four weekly 1-hr group discussions and 1-hr exercise classes, followed by monthly maintenance sessions. The Short Physical Performance Battery (SPPB) measured physical function throughout the 24-month intervention. No significant difference in physical function between intervention arms was evident over time. However, both groups experienced significant improvements in physical function at 24 months (β = 0.43, 95% confidence interval [CI] = [0.16, 0.70]). Participating in the exercise intervention was associated with improvements in physical function, although no additional gains were apparent for age attribution-retraining. Future research should consider strengthening or modifying intervention content for age reattribution or dosage received.",2020,"However, both groups experienced significant improvements in physical function at 24 months (β = 0.43, 95% confidence interval [CI] = [0.16, 0.70]).","['older Hispanics', 'Participants ( n = 565, ≥60 years', 'Older Hispanics', 'Hispanic Older Adults']","['exercise intervention', 'treatment group-attribution-retraining, or (b) control group-health education', 'Evidence-Based Exercise and Age Reattribution']","['physical function', 'Short Physical Performance Battery (SPPB) measured physical function']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0233899,"However, both groups experienced significant improvements in physical function at 24 months (β = 0.43, 95% confidence interval [CI] = [0.16, 0.70]).","[{'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Burrows', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Flavia Cristina Drumond', 'Initials': 'FCD', 'LastName': 'Andrade', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Lissette', 'Initials': 'L', 'LastName': 'Piedra', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Aguiñaga', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Nessa', 'Initials': 'N', 'LastName': 'Steinberg', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sarkisian', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Hernandez', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820927171'] 1695,32235883,Safety and immunogenicity of Ad26 and MVA vaccines in acutely treated HIV and effect on viral rebound after antiretroviral therapy interruption.,"We administered Ad26, modified vaccinia Ankara vectors containing mosaic HIV-1 antigens or placebo in 26 individuals who initiated antiretroviral therapy during acute human immunodeficiency virus infection as an exploratory study to determine the safety and duration of viremic control after treatment interruption. The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).",2020,"The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).",['26 individuals who initiated antiretroviral therapy during acute human immunodeficiency virus infection'],"['Ad26 and MVA vaccines', 'Ad26, modified vaccinia Ankara vectors containing mosaic HIV-1 antigens or placebo', 'placebo']",['delayed time to viral rebound'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0343752', 'cui_str': 'Acute HIV infection'}]","[{'cui': 'C3178367', 'cui_str': 'MVA vaccine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439750', 'cui_str': 'Mosaic'}, {'cui': 'C0369498', 'cui_str': 'HIV-1 antigen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}]",26.0,0.159031,"The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).","[{'ForeName': 'Donn J', 'Initials': 'DJ', 'LastName': 'Colby', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sarnecki', 'Affiliation': 'Janssen Vaccines, Bern, Switzerland.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Tipsuk', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, the Netherlands.'}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Kroon', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schuetz', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Jintana', 'Initials': 'J', 'LastName': 'Intasan', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Sacdalan', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Suteeraporn', 'Initials': 'S', 'LastName': 'Pinyakorn', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Pornsuk', 'Initials': 'P', 'LastName': 'Grandin', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Hongshuo', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Sodsai', 'Initials': 'S', 'LastName': 'Tovanabutra', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Shubin', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Paquin-Proulx', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'de Souza', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Wieczorek', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Victoria R', 'Initials': 'VR', 'LastName': 'Polonis', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Pagliuzza', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Montréal, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chomont', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Montréal, Canada.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vingerhoets', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, the Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, the Netherlands.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Michael', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. mrobb@hivresearch.org.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jintanat', 'Initials': 'J', 'LastName': 'Ananworanich', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}]",Nature medicine,['10.1038/s41591-020-0774-y'] 1696,32500154,The poor long-term outcomes of owl's eye pulmonary reconstruction technique after arterial switch operation.,"OBJECTIVES This study aims to compare the early- and long-term outcomes of patients who undergo owl's eye pulmonary artery (PA) reconstruction to those of patients who undergo conventional PA reconstruction. METHODS From January 2016 to January 2017, 64 consecutive patients underwent an arterial switch operation. The patients were divided into 2 groups in terms of neo-PA reconstruction method: 30 patients who underwent neo-PA reconstruction by owl's eye technique were defined as group 1 and 34 patients who underwent neo-PA reconstruction by the conventional approach were defined as group 2. In the final model, after propensity matching, 23 patients from each group with similar propensity scores were included in the study. RESULTS There was no significant difference between the groups regarding patient characteristics and operative findings. In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03). In the late period, the rate of severe neo-PS and reintervention was significantly higher in the owl's eye group (P = 0.02 and 0.04). Furthermore, the rates of 3-year freedom from pulmonary reintervention and freedom from moderate-severe neo-PS were significantly lower in group 1 (P = 0.04). In addition, the owl's eye reconstruction was the only factor independently related to moderate-severe neo-PS in the long term (hazard ratios = 11.2, P = 0.02). CONCLUSIONS We have abandoned the owl's eye method for neo-PA reconstruction of the neo-PA because of serious complications. According to our series and the literature, reconstruction of the neo-PA with an oversized, pantaloon-shaped fresh autologous pericardial patch is still superior to the other techniques.",2020,"In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03).","['From January 2016 to January 2017, 64 consecutive patients underwent an arterial switch operation', ""patients who undergo owl's eye pulmonary artery (PA) reconstruction to those of patients who undergo conventional PA reconstruction"", '23 patients from each group with similar propensity scores were included in the study']","[""neo-PA reconstruction method: 30 patients who underwent neo-PA reconstruction by owl's eye technique were defined as group 1 and 34 patients who underwent neo-PA reconstruction by the conventional approach"", ""owl's eye pulmonary reconstruction technique after arterial switch operation""]","['duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS', 'rates of 3-year freedom from pulmonary reintervention and freedom from moderate-severe neo-PS', 'rate of severe neo-PS and reintervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0397344', 'cui_str': 'Arterial switch operation'}, {'cui': 'C0326066', 'cui_str': 'Family Strigidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0326066', 'cui_str': 'Family Strigidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0397344', 'cui_str': 'Arterial switch operation'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0034089', 'cui_str': 'Pulmonic valve stenosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",64.0,0.0188175,"In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Dedemoğlu', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Mersin City Training and Research Hospital, Mersin, Turkey.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Korun', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gültekin', 'Initials': 'G', 'LastName': 'Coşkun', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Özdemir', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Gazi Yaşargil Education and Research Hospital, Diyarbakır, Turkey.'}, {'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Yurdakök', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Çiçek', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Biçer', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Health Sciences University Erzurum Region Education and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Nurgül', 'Initials': 'N', 'LastName': 'Yurtseven', 'Affiliation': 'Department of Anesthesia and Reanimation, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Şaşmazel', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Numan Ali', 'Initials': 'NA', 'LastName': 'Aydemir', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa067'] 1697,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM). METHODS In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. RESULTS At least 296 participants and approximately 75 peer supporters will be enrolled. DISCUSSION Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes. TRIAL REGISTRATION The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. ","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. ","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048'] 1698,32497927,Influence of type 1 diabetes on the postural control of women in the third gestational trimester.,"BACKGROUND Diabetes can cause biomechanical alterations that may be responsible for additional changes to those existing in a regular gestational period. The way a maternal body responds when affected by diabetes has not been clearly understood. This study aimed to describe the influence of type 1 diabetes on pregnant women's postural control. METHODS Forty pregnant women in their third gestational trimester were allocated in two equal groups - the control group and the type 1 diabetic group. The variables related to postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure). FINDINGS The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles. In the baropodometry, the anteroposterior distance and the amplitude of the center of pressure displacement with eyes open and closed were higher. INTERPRETATION The findings suggest that type 1 diabetes mellitus in the third trimester of pregnancy is associated with postural changes, a decrease in the active ankle range of motion and increase in the anteroposterior oscillation of the center of pressure, with negative repercussions for postural control.",2020,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","['Forty pregnant women in their third gestational trimester', 'women in the third gestational trimester', ""pregnant women's postural control""]",[],"['postural analysis, lower head protrusion and pelvic anteversion angles', 'postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure', 'cervical lordosis, thoracic kyphosis, and lumbar lordosis angles']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",[],"[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024003', 'cui_str': 'Lordosis accentuated'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",40.0,0.0325439,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","[{'ForeName': 'Paola Marini', 'Initials': 'PM', 'LastName': 'Valerio', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: paola.marini@usp.br.'}, {'ForeName': 'Vanessa Ellen', 'Initials': 'VE', 'LastName': 'Gonçalves', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: vanessa.ellen.goncalves@usp.br.'}, {'ForeName': 'Catarina Clapis', 'Initials': 'CC', 'LastName': 'Zordão', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: catarina.zordao@usp.br.'}, {'ForeName': 'Monique Silva', 'Initials': 'MS', 'LastName': 'Rezende', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: moniquerezende@usp.br.'}, {'ForeName': 'Elaine Christine Dantas', 'Initials': 'ECD', 'LastName': 'Moisés', 'Affiliation': 'Postgraduate Program in Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: elainemoises@fmrp.usp.br.'}, {'ForeName': 'Elaine Caldeira de Olveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105062'] 1699,32503545,Post-hospital medical respite care for homeless people in Denmark: a randomized controlled trial and cost-utility analysis.,"BACKGROUND Being homeless entails higher mortality, morbidity, and prevalence of psychiatric diseases. This leads to more frequent and expensive use of health care services. Medical respite care enables an opportunity to recuperate after a hospitalization and has shown a positive effect on readmissions, but little is known about the cost-effectiveness of medical respite care for homeless people discharged from acute hospitalization. Therefore, the aim of the present study was to investigate the cost-effectiveness of a 2-week stay in post-hospital medical respite care. METHODS A randomized controlled trial and cost-utility analysis, from a societal perspective, was conducted between April 2014 and March 2016. Homeless people aged > 18 years with an acute admission were included from 10 different hospitals in the Capital Region of Denmark. The intervention group (n = 53) was offered a 2-week medical respite care stay at a Red Cross facility and the control group (n = 43) was discharged without any extra help (usual care), but with the opportunity to seek help in shelters and from street nurses and doctors in the municipalities. The primary outcome was the difference in health care costs 3 months following inclusion in the study. Secondary outcomes were change in health-related quality of life and health care costs 6 months following inclusion in the study. Data were collected through Danish registries, financial management systems in the municipalities and at the Red Cross, and by using the EQ-5D questionnaire. RESULTS After 3 and 6 months, the intervention group had €4761 (p = 0.10) and €8515 (p = 0.04) lower costs than the control group, respectively. Crude costs at 3 months were €8448 and €13,553 for the intervention and control group respectively. The higher costs in the control group were mainly related to acute admissions. Both groups had minor quality-adjusted life year gains. CONCLUSIONS This is the first randomized controlled trial to investigate the cost-effectiveness of a 2-week medical respite care stay for homeless people after hospitalization. The study showed that the intervention is cost-effective. Furthermore, this study illustrates that it is possible to perform research with satisfying follow-up with a target group that is hard to reach. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02649595.",2020,,['homeless people in Denmark'],[],[],"[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]",[],[],,0.129307,,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Bring', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark. camillabring@hotmail.com.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kruse', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Mikkel Z', 'Initials': 'MZ', 'LastName': 'Ankarfeldt', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Brünés', 'Affiliation': 'Patient Care, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}]",BMC health services research,['10.1186/s12913-020-05358-4'] 1700,32504593,Low-dose fractionated radiation with induction docetaxel and cisplatin followed by concurrent cisplatin and radiation therapy in locally advanced nasopharyngeal cancer: A randomized phase II-III trial.,"OBJECTIVE/BACKGROUND To evaluate the efficacy and outcome of adding low-dose fractionated radiotherapy (LDFRT) to induction chemotherapy plus concurrent chemoradiation in locally advanced nasopharyngeal carcinoma (LANPC). METHODS A single-institute, phase II-III, prospectively controlled randomized clinical trial was performed at King Faisal Specialist Hospital and Research Centre. Patients aged 18-70 years with WHO type II and III, stage III-IVB nasopharyngeal carcinoma, Eastern Cooperative Oncology Group performance score of 0-2, with adequate hematological, renal, and hepatic function were eligible. In total, 108 patients were enrolled in this trial. All patients received two cycles of induction docetaxel and cisplatin (75 mg/m 2 each) chemotherapy on Days 1 and 22, followed by concurrent chemoradiation therapy. Radiation therapy consisted of 70 Gy in 33 fractions, with concurrent cisplatin 25 mg/m 2 for 4 days on Days 43 and 64. Patients were randomly assigned to either adding LDFRT (0.5 Gy twice daily 6 hours apart for 2 days) to induction chemotherapy in the experimental arm (54 patients) or induction chemotherapy alone in the control arm (54 patients). RESULTS There was no significant difference in the post-induction response rates (RRs) or in toxicity between the two treatment arms. The 3-year overall survival (OS), locoregional control (LRC), and distant metastases-free survival (DMFS) rates for experimental arm and control arm were 94% versus 93% (p = .8), 84.8% versus 87.5% (p = .58), and 84.1% versus 91.6% (p = .25), respectively. CONCLUSION The results showed no benefit from adding LDFRT to induction chemotherapy in terms of RR, OS, LRC, and DMFS.",2020,There was no significant difference in the post-induction response rates (RRs) or in toxicity between the two treatment arms.,"['Patients aged 18-70\u202fyears with WHO type II and III, stage III-IVB nasopharyngeal carcinoma, Eastern Cooperative Oncology Group performance score of 0-2, with adequate hematological, renal, and hepatic function were eligible', '108 patients were enrolled in this trial', 'A single-institute, phase II-III, prospectively controlled randomized clinical trial was performed at King Faisal Specialist Hospital and Research Centre', 'locally advanced nasopharyngeal carcinoma (LANPC', 'locally advanced nasopharyngeal cancer']","['Low-dose fractionated radiation with induction docetaxel and cisplatin followed by concurrent cisplatin and radiation therapy', 'LDFRT', 'concurrent cisplatin', 'induction chemotherapy alone', 'induction chemotherapy plus concurrent chemoradiation', 'induction chemotherapy', 'induction docetaxel and cisplatin', 'low-dose fractionated radiotherapy (LDFRT']","['RR, OS, LRC, and DMFS', '3-year overall survival (OS), locoregional control (LRC), and distant metastases-free survival (DMFS) rates', 'post-induction response rates (RRs) or in toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0153392', 'cui_str': 'Malignant tumor of nasopharynx'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",108.0,0.058704,There was no significant difference in the post-induction response rates (RRs) or in toxicity between the two treatment arms.,"[{'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Rajhi', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia. Electronic address: nrajhi@kfshrc.edu.sa.'}, {'ForeName': 'Ehab M', 'Initials': 'EM', 'LastName': 'Khalil', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Shoaib', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Soudy', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'AlGhazi', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Doha M', 'Initials': 'DM', 'LastName': 'Fatani', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Memon', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Moheieldin', 'Initials': 'M', 'LastName': 'Abouzied', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Khafaga', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}]",Hematology/oncology and stem cell therapy,['10.1016/j.hemonc.2020.05.005'] 1701,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995'] 1702,32507490,TEMPORARY REMOVAL: Comparison of Preadministered and Coadministered Lidocaine for Treating Pain and Distress Associated With Intranasal Midazolam Administration in Children: A Randomized Clinical Trial.,"The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.",2020,Coadministered lidocaine is noninferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration and was preferred by clinicians.,"['Fifty-one patients were analyzed, with a median age of 2 years', 'Children', 'Children aged 6 months to 7 years undergoing laceration repair received']","['midazolam (preadministered lidocaine', 'Midazolam', 'intranasal lidocaine', 'lidocaine', 'Coadministered lidocaine', 'Preadministered and Coadministered Lidocaine', 'preadministered lidocaine', 'midazolam', 'lidocaine with midazolam', 'intranasal midazolam with preadministered or coadministered lidocaine']","[""Children's Hospital of Eastern Ontario Pain Scale (CHEOPS); Faces, Legs, Activity, Cry, Consolability (FLACC) scale; and cry duration (secondary outcomes"", 'OSBD-R, CHEOPS, FLACC scores, and cry duration', 'OSBD-R scores', 'pain and distress', 'Observational Scale of Behavioral Distress-Revised (OSBD-R', 'CHEOPS and FLACC scores and cry duration', 'adverse events, clinician and caregiver satisfaction, and pain and distress associated with intranasal lidocaine administration', 'Pain and distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3701948', 'cui_str': 'Laceration repair'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",51.0,0.201182,Coadministered lidocaine is noninferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration and was preferred by clinicians.,"[{'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY; Department of Emergency Medicine, Westchester Medical Center, Valhalla, NY.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Woodward', 'Affiliation': ""Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY; NewYork-Presbyterian Morgan Stanley Children's Hospital, New York, NY.""}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Flores-Sanchez', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Son H', 'Initials': 'SH', 'LastName': 'McLaren', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ieni', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'McKinley', 'Affiliation': ""Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY; Division of Emergency Medicine, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Sripriya T', 'Initials': 'ST', 'LastName': 'Shen', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Dayan', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Tsze', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.04.025'] 1703,32505213,"A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-Cell lymphoma: final analysis of GOYA.","BACKGROUND Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) is the current standard therapy for diffuse large B cell lymphoma (DLBCL). Obinutuzumab (G), a glycoengineered, type II anti-CD20 monoclonal antibody, has shown activity and an acceptable safety profile when combined with CHOP (G-CHOP) in patients with advanced DLBCL. We present the final analysis results of the Phase III GOYA study (NCT01287741), which compared the efficacy and safety of G-CHOP versus R-CHOP in patients with previously untreated DLBCL. METHODS Patients aged ≥ 18 years with previously untreated advanced DLBCL were randomly assigned to receive eight 21-day cycles of R or G, plus six or eight cycles of CHOP. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival, other time-to-event endpoints, and safety; investigator-assessed PFS by cell of origin subgroup was an exploratory endpoint. RESULTS A total of 1418 patients were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; R-CHOP, N = 710). Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48). The results of the secondary efficacy endpoints did not show a benefit of G-CHOP over R-CHOP. In the exploratory analysis, a trend towards benefit with G-CHOP over R-CHOP was apparent in the patients with germinal center B cell DLBCL. The safety profile of G-CHOP was as expected, and no new safety signals were observed. More grade 3-5 (75.1% vs 65.8%), serious (44.4% vs 38.4%), and fatal (6.1% vs 4.4%) adverse events (AEs) were observed in the G-CHOP arm compared with the R-CHOP arm, respectively, with the most common fatal AEs being infections. A higher incidence of late-onset neutropenia occurred in the G-CHOP arm (8.7%) versus the R-CHOP arm (4.9%). CONCLUSIONS The final analysis, similar to the primary analysis, did not show a PFS benefit of G-CHOP over R-CHOP in previously untreated patients with DLBCL. The results of the secondary endpoints were consistent with the primary endpoint. Further exploratory analyses and investigation of biomarkers are ongoing.",2020,"Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48).","['patients with advanced DLBCL', 'patients with germinal center B cell DLBCL', 'patients with previously untreated DLBCL', 'A total of 1418 patients were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; R-CHOP, N = 710', 'diffuse large B cell lymphoma (DLBCL', 'patients with previously untreated diffuse large B-Cell lymphoma', 'Patients aged ≥ 18\u2009years with previously untreated advanced DLBCL']","['obinutuzumab or rituximab plus CHOP', 'Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP', 'R or G, plus six or eight cycles of CHOP', 'G-CHOP', 'G-CHOP versus R-CHOP', 'CHOP (G-CHOP', 'Obinutuzumab (G']","['investigator-assessed progression-free survival (PFS', 'overall survival, other time-to-event endpoints, and safety; investigator-assessed PFS', 'benefit of G-CHOP over R-CHOP', 'PFS benefit of G-CHOP', 'efficacy and safety', 'late-onset neutropenia', 'PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0282491', 'cui_str': 'Structure of germinal center of lymph node'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3805247', 'cui_str': 'Late onset neutropenia'}]",1418.0,0.285844,"Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48).","[{'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'BC Cancer Centre for Lymphoid Cancer and the University of British Columbia, Vancouver, BC, Canada. Lsehn@bccancer.bc.ca.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Martelli', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trněný', 'Affiliation': 'Charles University General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Roche Pharma Development, Shanghai, China.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bolen', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Knapp', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Sahin', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Sellam', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Candiolo Cancer Institute, FPO-IRCCS, (Turin), Candiolo, Italy.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00900-7'] 1704,32511749,Clinical outcomes and safety profile of Tenecteplase in wake-up stroke.,"BACKGROUND Tenecteplase has probably pharmacological and clinical advantages in the treatment of acute ischemic stroke. There are lacking data about safety and efficacy of tenecteplase in wake-up stroke (WUPS). AIMS To investigate safety and efficacy of tenecteplase compared to alteplase in WUPS patients included in NOR-TEST. METHODS WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch. Included patients randomly assigned (1:1) to receive intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase 0.9 mg/kg (to a maximum of 90 mg). Neurological improvement was defined as 1) favorable functional outcome at 90 days modified Rankin Scale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS) of 4 points within 24 hours as compared to admission NIHSS or NIHSS 0 at 24 hours. RESULTS Of 1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients. Of these, 5 patients were stroke mimics and excluded. Of the remaining 40 patients (3.6%), 24 were treated with alteplase (60%). There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group. Patients treated with tenecteplase showed a better early neurological improvement (87.5% vs 54.2%, P = 0.027). No ICH was detected on MRI/CT 24-28 hours after thrombolysis. CONCLUSIONS In WUPS patients treated in NOR-TEST, there was no difference in clinical outcomes at 90 days and no ICH events or deaths were observed in either alteplase- or tenecteplase-treated patients. Clinical Trial Registration-URL: https://www.clinicaltrials.gov. Unique identifier: NCT01949948.",2020,There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group.,"['1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients', 'WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch', 'WUPS patients included in NOR-TEST']",['intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase'],"['early neurological improvement', 'number of patients achieving a good clinical outcome', 'clinical outcomes', 'favorable functional outcome at 90 days modified RankinScale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS', 'safety and efficacy', 'ICH events or deaths', 'Neurological improvement']","[{'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1100.0,0.0389672,There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group.,"[{'ForeName': 'Hassan Khan', 'Initials': 'HK', 'LastName': 'Ahmed', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Logallo', 'Affiliation': 'Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Thomassen', 'Affiliation': 'Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Novotny', 'Affiliation': 'Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Mathisen', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Martin W', 'Initials': 'MW', 'LastName': 'Kurz', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}]",Acta neurologica Scandinavica,['10.1111/ane.13296'] 1705,32511774,Dietary sodium intake and cortisol measurements.,"OBJECTIVES To assess the influence of a dietary sodium intake intervention on cortisol measurements within the general population. DESIGN Cross-over intervention. PATIENTS Six hundred thirty adults without known Cushing syndrome, cardiovascular or renal disease completed a restricted dietary sodium diet (10 mmol/d, 230 mg/d) followed by cross-over to a liberalized dietary sodium diet (200 mmol/d, 4600 mg/d). Twenty-four-hour urine collection and biochemical investigations were performed at the end of each dietary intervention. RESULTS Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs 121.3 ± 65.6 nmol/d, P < .001). Nearly all participants (84%) had an increase in the urinary free cortisol following liberalized sodium intake. This translated to a substantial difference in the proportion of participants exceeding categorical thresholds of urinary cortisol on liberalized vs restricted sodium intake: 62% vs 27% for 138 nmol/d (50 mcg/d), 46% vs 17% for 166 nmol/d (60 mcg/d), 32% vs 10% for 193 nmol/d (70 mcg/d), 23% vs 6% for 221 nmol/d (80 mcg/d), 17% vs 4% for 248 nmol/d (90 mcg/d). In parallel, there was a small decrease in morning total serum cortisol with liberalized sodium intake (303.0 ± 117.3 vs 326.4 ± 162.5 nmol/L, P < .001). CONCLUSIONS Increased dietary sodium intake increases urinary free cortisol excretion and may increase the risk for false-positive results. Variations in dietary sodium intake may influence the interpretations of cortisol measurements performed to evaluate for hypercortisolism.",2020,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","['630 adults without known Cushing syndrome, cardiovascular or renal disease completed a']","['restricted dietary sodium diet (10 mmol/day, 230 mg/day) followed by cross-over to a liberalized dietary sodium diet', 'dietary sodium intake intervention']","['Mean 24-hour urinary free cortisol', 'Dietary Sodium Intake and Cortisol Measurements', 'morning total serum cortisol', 'urinary free cortisol', 'cortisol measurements']","[{'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439433', 'cui_str': 'mmol/24h'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}]",630.0,0.0210742,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Andrea V', 'Initials': 'AV', 'LastName': 'Haas', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Williams', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical endocrinology,['10.1111/cen.14262'] 1706,32512513,The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.,"BACKGROUND Craving is a central feature of addiction. Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder (OUD). However, trials in large populations of patients with OUDs are lacking. METHODS We randomly assigned 118 male heroin patients into three groups (i.e., 10 Hz rTMS, 1 Hz rTMS and a wait-list control group) from two addiction rehabilitation centers. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 daily consecutive sessions. FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group. The treatment effects lasted for up to 60 days after rTMS treatment cessation. INTERPRETATION Our results suggest that rTMS applied to the DLPFC is effective in reducing craving severity in heroin use disorder patients. Our results also suggest that such treatment effects can last for up to 60 days after treatment cessation.",2020,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","['male patients with heroin use disorder', '118 male heroin patients into three groups (i.e., 10', 'heroin use disorder patients', 'patients with opioid use disorder (OUD']","['repetitive transcranial magnetic stimulation', 'rTMS', 'Hz rTMS, 1\u202fHz rTMS and a wait-list control group) from two addiction rehabilitation centers']","['cue-induced craving scores', 'craving severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",118.0,0.0241904,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China; Ningbo Key Laboratory of Sleep Medicine, Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT, U.S.A.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, U.S.A.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, U.S.A.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, China; Key Laboratory of Brain and Cognitive Neurosience, Liaoning Province, China. Electronic address: luowb@lnnu.edu.cn.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ont., Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102809'] 1707,32512517,Association between cellular HIV-1 DNA level and mortality in HIV-1 infected African adults starting ART with high CD4 counts.,"BACKGROUND High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa. METHODS In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality. FINDINGS 2019 patients were followed for 9253 patient-years (median 4.9 years). At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3]. During follow-up, 86 participants died. In univariate analysis, the hazard ratio [HR] of death was 2.67 (95% CI, 1.68-4.22) for patients with HIV-1 DNA ≥3 log 10 copies/million PBMC vs. others, and 2.10 (95% CI, 1.38-3.21) for patients with HIV-1 RNA ≥5 log10 copies/ml vs. others. In multivariate Cox regression analysis, HIV-1 DNA levels ≥3 log 10 copies/million PBMC were strongly associated mortality (adjusted HR = 2.09, 95% CI 1.24-3.52, p= 0.005) while the association between baseline plasma HIV-1 RNA and mortality was not significant. INTERPRETATION In these African adults who started ART with high CD4 counts, HIV-1 DNA was a strong independent predictor of death. The HIV reservoir still plays a prognostic role in the early ART era. FUNDING This trial was supported by the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France; Grants ANRS 12136, 12224 and 12253).",2020,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","['HIV-infected adults in a trial of early ART in West Africa', '2019 patients were followed for 9253 patient-years (median 4.9 years', 'HIV-infected adults', 'HIV-1 infected African adults starting ART with high CD4 counts']",[],"['median plasma HIV-1 RNA', 'hazard ratio [HR] of death', 'HIV-1 DNA and mortality', 'HIV-1 DNA', 'mortality', 'median CD4 count', 'baseline plasma HIV-1 RNA and mortality', 'CD4 count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2019.0,0.300537,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': ""N'takpe"", 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire. Electronic address: jean-baptiste.ntakpe@u-bordeaux.fr.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gardiennet', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Emieme', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': ""Thomas-d'Aquin"", 'Initials': 'TD', 'LastName': 'Toni', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Jérome Le', 'Initials': 'JL', 'LastName': 'Carrou', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ménan', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': ""PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102815'] 1708,32512963,"[Influences of acute hypervolemic hemodilution on serum levels of S-100β protein, NSE and POCD in elderly patients with spinal surgery].","OBJECTIVE To explore the influences of acute hypervolemic hemodilution(AHH) on serum levels of S-100β protein, neuron specific enolase(NSE) and postoperative cognitive dysfunction POCD in elderly patients with spinal surgery. METHODS A total of 80 cases elderly patients requiring elective spinal operation were divided into AHH group and C group according to random digits table, 40 cases in each group, with ASA grade I-II. The patients in AHH group were infused 6% hydroxyethyl starch 130/0.4 at a rate of 20 ml/min after anesthesia induction, and blood volume increased by about 20%, the patients in C group were not received AHH, anesthesia and surgical methods were the same as those in AHH group. Intraoperative blood volume, allogeneic blood transfusion and urine volume were recorded. Mean arterial pressure(MAP), heart rate(HR), central venous pressure(CVP) at preoperative 1 d, 1 h after the start of surgery, end of operation, 12 h after surgery were observed. Arterial blood oxygen content (CaO₂), venous blood oxygen content (CjvO₂), arteriovenous oxygen content difference (Da-jvO₂), and cerebral oxygen uptake(CERO₂) were measured at 1 d before surgery, 15 min after surgery, 45 min after surgery, end of surgery. Mini-mental state examination(MMSE) score and serum levels of S-100β protein, NSE were measured at 1 d before surgery, 1, 3, 7 d after surgery. POCD rates of two groups were recorded. RESULTS Intraoperative blood loss and allogeneic blood transfusion in AHH group was significantly lower than those in C group( P <0.05), and the urine volume was significantly higher than that in C group ( P <0.05). Compared with preoperative 1 day, MAP was decreased and CVP was increased at end of surgery in AHH group, compared with C group at the same time, MAP was lower and CVP was higher in AHH group, but both were in normal range. Compared with preoperative 1 day and C group, the levels of Da-jvO₂ and CERO₂ in AHH group was decreased at 15, 45 min after the start of the operation and end of surgery( P <0.05). Compared with preoperative 1 day, MMSE scores of two groups at 1 day after surgery was decreased ( P <0.05), the levels of S-100β protein and NSE were increased( P <0.05), and restored at 3, 7 days after surgery. There was statistical difference in MMSE scores, the levels of S-100β protein, NSE at 1 day after surgery between two groups ( P <0.05). There was no statistical difference in POCD rate between two groups( P >0.05). CONCLUSIONS AHH can significantly reduce intraoperative blood loss and blood transfusion in elderly patients with spinal surgery, and decrease the levels of S-100β protein and NSE, does not increase the risk of the occurrence of POCD.",2019,"There was statistical difference in MMSE scores, the levels of S-100β protein, NSE at 1 day after surgery between two groups ( P <0.05).","['elderly patients with spinal surgery', '80 cases elderly patients requiring elective spinal operation']","['hydroxyethyl starch', 'acute hypervolemic hemodilution', 'acute hypervolemic hemodilution(AHH']","['Intraoperative blood loss and allogeneic blood transfusion', 'Mini-mental state examination(MMSE) score and serum levels of S-100β protein, NSE', 'levels of S-100β protein and NSE', 'serum levels of S-100β protein, NSE and POCD', 'Mean arterial pressure(MAP), heart rate(HR), central venous pressure(CVP', 'Arterial blood oxygen content (CaO₂), venous blood oxygen content (CjvO₂), arteriovenous oxygen content difference (Da-jvO₂), and cerebral oxygen uptake(CERO₂', 'POCD rates', 'MMSE scores', 'blood volume', 'MMSE scores, the levels of S-100β protein, NSE', 'intraoperative blood loss and blood transfusion', 'levels of Da-jvO₂ and CERO₂', 'CVP', 'urine volume', 'Intraoperative blood volume, allogeneic blood transfusion and urine volume', 'POCD rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0185908', 'cui_str': 'Operative procedure on spinal structure'}]","[{'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0042486', 'cui_str': 'Venous pressure'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]",80.0,0.0408016,"There was statistical difference in MMSE scores, the levels of S-100β protein, NSE at 1 day after surgery between two groups ( P <0.05).","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China; qw6654359@163.com.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Qi', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.3969/j.issn.1003-0034.2019.10.010'] 1709,32513273,The effect of transtheoretical model-lead intervention for knee osteoarthritis in older adults: a cluster randomized trial.,"BACKGROUND Knee osteoarthritis (KOA) is a common joint disease in people over 60 years old. Exercise therapy is one of the most effective non-pharmacological treatments for KOA, but low exercise adherence needs to be improved. The present study aimed to evaluate the effect of the transtheoretical model-lead home exercise intervention (TTM-HEI) program on exercise adherence, KOA symptoms, and knee function in older adults with KOA. METHODS A two-arm, superiority, assessor-blinded, cluster randomized trial was conducted. Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China, via print and social media advertisements from April to October 2018. The present study lasted 48 weeks, with an intervention duration of 0-24 weeks and follow-up time of 24-48 weeks. The intervention was a two-stage and 24-week TTM-based exercise program, and the control group underwent a same-length exercise program guidance without any exercise adherence interventions. The primary outcome was exercise adherence to the prescribed home exercise program and was measured using an 11-point numerical (0 = not at all through and 10 = completely as instructed) self-rating scale at weeks 4, 12, 24, 36, and 48 after the program started. KOA symptoms (pain intensity and joint stiffness) were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and knee function (lower limb muscle strength and balance) was measured using the Five-Times-Sit-to-Stand Test (FTSST) and the Timed Up and Go Test (TUG) at baseline, week 24, and week 48. Latent growth model (GLM), repeated measures ANOVA, and independent t test were the main statistical tests used. RESULTS A total of 189 older adults (intervention group: n = 103, control group: n = 86) were enrolled. Differences of any outcome measures at baseline were not significant between groups. The growth rate of exercise adherence in the intervention group increased 2.175 units compared with that in the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants' exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48. In addition, the TTM-HEI program showed significant effects on relieving KOA symptoms and improving knee function. CONCLUSION Over time, TTM-HEI could improve participants' exercise adherence, KOA symptoms, and knee function. TRIAL REGISTRATION This study was approved by the ethics committee (IRB00001052-17066) in July 2017 and was registered at the Chinese Clinical Trial Registry (website: www.chictr.org.cn, registry number: ChiCTR1800015458).",2020,"The growth rate of exercise adherence in the intervention group increased 2.175 units compared with that in the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants' exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48.","['Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China, via print and social media advertisements from April to October 2018', 'knee osteoarthritis in older adults', 'older adults with KOA', '189 older adults (intervention group: n\u2009=\u2009103, control group: n\u2009=\u200986) were enrolled', 'people over 60\u2009years old']","['transtheoretical model-lead home exercise intervention (TTM-HEI) program', 'TTM-based exercise program, and the control group underwent a same-length exercise program guidance without any exercise adherence interventions', 'Exercise therapy', 'transtheoretical model-lead intervention']","['growth rate of exercise adherence', 'exercise adherence to the prescribed home exercise program and was measured using an 11-point numerical (0\u2009=\u2009not at all through and 10\u2009=\u2009completely as instructed) self-rating scale', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and knee function (lower limb muscle strength and balance', ""participants' exercise adherence, KOA symptoms, and knee function"", 'relieving KOA symptoms and improving knee function', 'exercise adherence, KOA symptoms, and knee function', 'exercise adherence', 'KOA symptoms (pain intensity and joint stiffness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}]",189.0,0.106611,"The growth rate of exercise adherence in the intervention group increased 2.175 units compared with that in the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants' exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48.","[{'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Yunlin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Jieru', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Recovery, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Qiaoqin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Shaomei', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China. shangshaomei@126.com.'}]",Arthritis research & therapy,['10.1186/s13075-020-02222-y'] 1710,32517117,Manipulating Self-Avatar Body Dimensions in Virtual Worlds to Complement an Internet-Delivered Intervention to Increase Physical Activity in Overweight Women.,"Virtual reality has been found to be a useful tool for positively influencing relevant psychological variables in order to increase physical activity (PA), especially in the overweight population. This study investigates the use of avatars and their physical variations to extend the effectiveness of existing interventions to promote PA. The main objective is to analyze the influence of the avatars' body dimensions on the efficacy of an Internet intervention to increase PA levels and improve other relevant variables (motivation toward PA, enjoyment, anxiety, self-efficacy, and PA goals). A total of 42 overweight women received a brief online intervention, and they were randomly assigned to one of three conditions: the ""Ideal avatar"" (IAC: participants are represented by avatars with ideal body dimensions); the ""Real avatar"" (RAC: participants are represented by avatars with participants' current body dimensions); and the ""Non avatar"" (NAC: participants are not represented by avatars). Results showed that the online intervention was effective in increasing PA practice and self-efficacy expectations. However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.",2020,"However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.","['Overweight Women', '42 overweight women']","['Internet intervention', 'Non avatar"" (NAC', 'brief online intervention', 'Ideal avatar"" (IAC: participants are represented by avatars with ideal body dimensions); the ""Real avatar"" (RAC']","['PA practice and self-efficacy expectations', 'PA levels and improve other relevant variables (motivation toward PA, enjoyment, anxiety, self-efficacy, and PA goals']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0668624', 'cui_str': 'AKT1 protein, human'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",42.0,0.0140915,"However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de investigación e Innovación en Bioingenieria, Universitat Politécnica de Valencia, 46022 Valencia, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Borrego', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de investigación e Innovación en Bioingenieria, Universitat Politécnica de Valencia, 46022 Valencia, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17114045'] 1711,32517582,Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial.,"BACKGROUND AND PURPOSE Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source. METHODS Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily. RESULTS During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7-4.3]), East Asia region (HR, 2.5 [95% CI, 1.6-3.9]), systolic blood pressure ≥160 mm Hg (HR, 2.2 [95% CI, 1.2-3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m 2 decrease, [95% CI, 1.0-1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin. CONCLUSIONS Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.",2020,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","['Patients With Embolic Strokes of Undetermined Source', 'patients with recent embolic stroke of undetermined source', 'Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global trial) embolic stroke', '15 patients with intracerebral hemorrhage, 2 (13%) were fatal']","['rivaroxaban', 'rivaroxaban 15 mg daily with aspirin 100 mg daily']","['annualized rate of intracerebral hemorrhage', 'systolic blood pressure, and impaired renal function', 'systolic blood pressure', 'glomerular filtration rate', 'Distribution of bleeding sites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3247999', 'cui_str': 'rivaroxaban 15 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}]","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",15.0,0.431584,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulík', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University Brno, Czech Republic (R.M.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eckstein', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Switzerland (J.E.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M.).'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Rudilosso', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience (S.R.), Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Veroníca V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Department of Neurology and Psychiatry, Faculty of Medicine, Universidad del Desarrollo, Clínica Alemana de Santiago, Santiago, Chile (V.V.O.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Chamorro', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience (A.C.), Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Hospital de La Santa Creu Isant Pau, Barcelona, Spain (J.M.-F.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Imperial College London, United Kingdom (R.V.).'}, {'ForeName': 'Şerefnur', 'Initials': 'Ş', 'LastName': 'Öztürk', 'Affiliation': 'Department of Neurology, Selcuk University Faculty of Medicine, Turkey (S.O.).'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden (T.T.).'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, TX (W.F.P.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ (S.D.B.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}]",Stroke,['10.1161/STROKEAHA.119.027995'] 1712,32519957,Polidocanol versus phenol in oil injection sclerotherapy in treatment of internal hemorrhoids: A randomized controlled trial.,"BACKGROUND/AIMS Management of Haemorrhoids is suboptimal and is largely based on traditional practices in the Indian population. Though injection sclerotherapy is a well-accepted treatment modality in early grade haemorrhoids, there is no consensus on the effectiveness of the drugs used for sclerotherapy. The study was done to compare the safety and efficacy of a standard sclerosant (polidocanol) and the conventionally used phenol in oil in bleeding grade-1 and 2 internal haemorrhoids. MATERIALS AND METHODS All patients with grade-1 and 2 hemorrhoids, were selected and randomised into two groups, 3% polidocanol and 5% phenol group. All patients were followed-up for three months and observed for ""free of bleeding"" or ""persistent bleeding."" Pain, pruritus and patient satisfaction following the procedure was also assessed. RESULTS A total of 150 patients were enrolled, 75 in each group. At the end of the first sclerotherapy session with polidocanol, 60.6% of patients versus 38.1% in phenol group had stopped per rectal bleeding (p=0.009). After the second sclerotherapy session, 94.7% of patients in the polidocanol group and 84% of patients in the phenol group were treated successfully. Polidocanol group required significantly fewer treatment sessions than the phenol group (1.39±0.49 vs. 1.62±0.49; p=0.035), and the total volume of injected sclerosant was also less (3.30±0.96 mL vs. 4.86±1.46 mL; p=0.001). The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). CONCLUSION 3% polidocanol is safe and more effective than 5% phenol in oil when used as injection sclerotherapy in the treatment of first and second-degree internal hemorrhoids.",2020,"The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). ","['All patients with grade-1 and 2 hemorrhoids', 'A total of 150 patients were enrolled, 75 in each group', 'internal hemorrhoids']","['polidocanol and 5% phenol group', 'polidocanol', 'standard sclerosant (polidocanol', 'Polidocanol versus phenol in oil injection sclerotherapy', 'injection sclerotherapy', 'Polidocanol']","['Pain, pruritus and patient satisfaction', 'total volume of injected sclerosant', 'patient satisfaction', 'safety and efficacy', 'free of bleeding"" or ""persistent bleeding', 'stopped per rectal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}]","[{'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036426', 'cui_str': 'Sclerosing agent'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0036426', 'cui_str': 'Sclerosing agent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}]",150.0,0.0796908,"The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). ","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Thirthar Palanivelu', 'Initials': 'TP', 'LastName': 'Elamurugan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Sadasivan', 'Initials': 'S', 'LastName': 'Jagdish', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19276'] 1713,32498073,Systematic manipulations of the biological stress systems result in sex-specific compensatory stress responses and negative mood outcomes.,"Women are twice as likely as men to be diagnosed with anxiety and mood disorders. One potential underlying mechanism is sex differences in physiological and psychological responses to stress; however, no studies to date have investigated this proposed mechanism experimentally. In a double-blind, placebo-controlled design, pharmacological challenges were administered to individually suppress the hypothalamic-pituitary-adrenal (HPA) axis, or the sympathetic nervous system (SNS) prior to stress exposure, to investigate sex differences in the resulting cross talk among the physiological and psychological stress responses. Sex-specific compensatory patterns and psychological effects emerged when the stress systems were manipulated. Men demonstrated heightened SNS reactivity to stress when the HPA axis was suppressed, and greater HPA reactivity after SNS suppression. This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects. In women, higher baseline activation (but dampened reactivity to stress) of SNS or HPA was observed when the other system was suppressed. This was coupled with worsened mood in response to stress when either stress system was compromised. Our results indicate that men and women may be differentially sensitive to fluctuations of their stress systems. This might be a potential link that underlies the sexual dimorphism in vulnerability for psychopathology.",2020,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.",[],['placebo'],['HPA reactivity'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0182391,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0726-8'] 1714,32502443,"Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study.","BACKGROUND Dual blockade of PD-L1 and VEGF has enhanced anticancer immunity through multiple mechanisms and augmented antitumour activity in multiple malignancies. We aimed to assess the efficacy and safety of atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF) in patients with unresectable hepatocellular carcinoma. METHODS GO30140 is an open-label, multicentre, multiarm, phase 1b study that enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide. The study included five cohorts, and the two hepatocellular carcinoma cohorts, groups A and F, are described here. Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1. In group A, all patients received atezolizumab (1200 mg) and bevacizumab (15 mg/kg) intravenously every 3 weeks. In group F, patients were randomly assigned (1:1) to receive intravenous atezolizumab (1200 mg) plus intravenous bevacizumab (15 mg/kg) every 3 weeks or atezolizumab alone by interactive voice-web response system using permuted block randomisation (block size of two) and stratification factors of geographical region; macrovascular invasion, extrahepatic spread, or both; and baseline α-fetoprotein concentration. Primary endpoints were confirmed objective response rate in all patients who received the combination treatment for group A and progression-free survival in the intention-to-treat population in group F, both assessed by an independent review facility according to Response Evaluation Criteria in Solid Tumors version 1.1. In both groups, safety was assessed in all patients who received at least one dose of any study treatment. This study is registered with ClinicalTrials.gov, NCT02715531, and is closed to enrolment. FINDINGS In group A, 104 patients were enrolled between July 20, 2016, and July 31, 2018, and received atezolizumab plus bevacizumab. With a median follow-up of 12·4 months (IQR 8·0-16·2), 37 (36%; 95% CI 26-46) of 104 patients had a confirmed objective response. The most common grade 3-4 treatment-related adverse events were hypertension (13 [13%]) and proteinuria (seven [7%]). Treatment-related serious adverse events occurred in 25 (24%) patients and treatment-related deaths in three (3%) patients (abnormal hepatic function, hepatic cirrhosis, and pneumonitis). In group F, 119 patients were enrolled and randomly assigned (60 to atezolizumab plus bevacizumab; 59 to atezolizumab monotherapy) between May 18, 2018, and March 7, 2019. With a median follow-up of 6·6 months (IQR 5·5-8·5) for the atezolizumab plus bevacizumab group and 6·7 months (4·2-8·2) for the atezolizumab monotherapy group, median progression-free survival was 5·6 months (95% CI 3·6-7·4) versus 3·4 months (1·9-5·2; hazard ratio 0·55; 80% CI 0·40-0·74; p=0·011). The most common grade 3-4 treatment-related adverse events in group F were hypertension (in three [5%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group) and proteinuria (in two [3%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group). Treatment-related serious adverse events occurred in seven (12%) patients in the atezolizumab plus bevacizumab group and two (3%) patients in the atezolizumab monotherapy group. There were no treatment-related deaths. INTERPRETATION Our study shows longer progression-free survival with a combination of atezolizumab plus bevacizumab than with atezolizumab alone in patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy. Therefore, atezolizumab plus bevacizumab might become a promising treatment option for these patients. This combination is being compared with standard-of-care sorafenib in a phase 3 trial. FUNDING F Hoffmann-La Roche/Genentech.",2020,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"['119 patients', 'patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy', 'unresectable hepatocellular carcinoma (GO30140', 'Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1', 'enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide', '104 patients were enrolled between July 20, 2016, and July 31, 2018, and received', 'patients with unresectable hepatocellular carcinoma']","['atezolizumab alone', 'intravenous atezolizumab (1200 mg) plus intravenous bevacizumab', 'atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF', 'atezolizumab', 'atezolizumab alone by interactive voice-web response system', 'Atezolizumab with or without bevacizumab', 'standard-of-care sorafenib', 'atezolizumab monotherapy', 'bevacizumab', 'atezolizumab plus bevacizumab']","['median progression-free survival', 'progression-free survival', 'efficacy and safety', 'serious adverse events', 'proteinuria', 'objective response rate', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",104.0,0.146586,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Stein', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Aiwu Ruth', 'Initials': 'AR', 'LastName': 'He', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Electronic address: kyunghunlee@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30156-X'] 1715,32503602,Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials.,"OBJECTIVES The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination. TRIAL DESIGN Two separate multi-centre placebo-controlled parallel group randomized trials PARTICIPANTS: (1) Health care personnel working in the hospital or ambulance service where they will take care of patients with the COVID-19 infection and (2) elderly ≥60 years. The HCW trial is being undertaken in 9 hospitals. The elderly trial is being undertaken in locations in the community in Nijmegen, Utrecht, and Veghel, in the Netherlands, using senior citizen organisations to facilitate recruitment. INTERVENTION AND COMPARATOR For both trials the intervention group will be randomized to vaccination with 0.1 ml of the licensed BCG vaccine (Danish strain 1331, SSI, Denmark, equivalent to 0.075 mg attenuated M. bovis). The placebo group consists of 0.1 ml 0.9% NaCl, which is the same amount, and has the same colour and appearance as the suspended BCG vaccine. MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. RANDOMISATION Participants will be randomized to BCG vaccine or placebo (1;1) centrally using a computer- based system, stratified by study centre. BLINDING (MASKING) Subjects, investigators, physicians and outcome assessors are blinded for the intervention. Only the pharmacist assistant that prepares- and research personnel that administers- study medicines are unblinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): (1) The sample size for the first trial is N=1500 HCWs randomised 1:1 to either BCG vaccine (n=750) and placebo (n=750) and (2) The sample size for the second trial is N=1600 elderly persons randomised to BCG vaccine (n=800) and the placebo group (n=800). TRIAL STATUS HCW: version 4.0, 24-04-2020. Recruitment began 25-03-2020 and was completed on the 23-04-2020. Elderly: version 3.0, 04-04-2020. Recruitment began 16-04- 2020 and is ongoing. TRIAL REGISTRATION The HCWs trial was registered 31-03-2020 at clinicaltrials.gov (identifier: NCT04328441) and registered 20-03-2020 at the Dutch Trial Registry (trialregister.nl, identifier Trial NL8477). The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547. FULL PROTOCOL The full protocols will be attached as additional files, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. ","['N=1600 elderly persons randomised to', 'The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547', 'Recruitment began 25-03-2020 and was completed on the 23-04-2020', 'patients with the COVID-19 infection and (2) elderly ≥60 years', 'HCW: version 4.0, 24-04-2020', 'health care workers and hospital admission by elderly persons during the COVID-19 pandemic']","['Bacillus Calmette-Guérin Vaccination', 'BCG vaccine', 'BCG vaccine or placebo', 'placebo']","['cumulative incidence of hospital admission', '1) Number of days of unplanned work absenteeism in HCWs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.395304,"MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. ","[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Ten Doesschate', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands. t.tendoesschate@umcutrecht.nl.'}, {'ForeName': 'Simone J C F M', 'Initials': 'SJCFM', 'LastName': 'Moorlag', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'van der Vaart', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Taks', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Debisarun', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Ten Oever', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Chantal P', 'Initials': 'CP', 'LastName': 'Bleeker-Rovers', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Patricia Bruijning', 'Initials': 'PB', 'LastName': 'Verhagen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Arief', 'Initials': 'A', 'LastName': 'Lalmohamed', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Ter Heine', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'van de Wijgert', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Axel B', 'Initials': 'AB', 'LastName': 'Janssen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Bonten', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04389-w'] 1716,32504895,Patterns of daytime physical activity in patients with chronic fatigue syndrome.,"OBJECTIVES To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type. METHODS 579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group. RESULTS 124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. CONCLUSION We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication.",2020,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. ","['patients with chronic fatigue syndrome', '579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy', 'patients with chronic fatigue syndrome (CFS']",[],"['sleep disturbance', 'daytime physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],"[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",641.0,0.0298142,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. ","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beynon', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, Weston Education Centre, London, UK. Electronic address: Trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'White', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110154'] 1717,32506539,Neurodevelopmental outcomes of a randomised trial of intact cord resuscitation.,"AIM It has been suggested that intact cord resuscitation can reduce the risk of brain damage. We investigated the effects on neurodevelopment at two years of age. METHODS This study was performed in Kathmandu, Nepal. In 2016, 231 late preterm and term infants born vaginally and not breathing were randomised to resuscitation with an intact cord or the standard practice of early cord clamping (CC). At two years of age, the World Health Organization's Infant and Young Child Development tool was used to assess the child's neurodevelopment, during telephone interviews with caregivers. RESULTS We followed up 138 infants (59.7%) at a mean age of 24.8 ± 0.8 months. A significant difference was seen in the development for age Z-score, between the group resuscitated with an intact umbilical cord and the group resuscitated with early CC. The median (range) scores were 1.0 (0.1-2.1) vs 0.9 (-2.0 to 1.8), respectively (P = .04). There was no difference in the motor, language-cognitive and socio-emotional domains. CONCLUSION Neurodevelopment improvements were observed at two years of age in infants resuscitated with an intact rather than early clamped umbilical cord. No definitive conclusions could be drawn due to protocol violations and a low follow-up rate. More research is needed.",2020,"A significant difference was seen in the development for age Z-score, between the group resuscitated with an intact umbilical cord and the group resuscitated with early CC.","['138 infants (59.7%) at a mean age of 24.8 ±0.8 months', 'In 2016, 231 late preterm and term infants born vaginally and not breathing']","['intact cord resuscitation', 'resuscitation with an intact cord or the standard practice of early cord clamping (CC']","['median (range) scores', 'motor, language-cognitive and socio-emotional domains']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.119022,"A significant difference was seen in the development for age Z-score, between the group resuscitated with an intact umbilical cord and the group resuscitated with early CC.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Isacson', 'Affiliation': 'Department of Clinical Sciences, Lund, Pediatrics/Neonatology, Lund University, Lund, Sweden.'}, {'ForeName': 'Rejina', 'Initials': 'R', 'LastName': 'Gurung', 'Affiliation': 'Golden Community, Kathmandu, Nepal.'}, {'ForeName': 'Omkar', 'Initials': 'O', 'LastName': 'Basnet', 'Affiliation': 'Golden Community, Kathmandu, Nepal.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Sciences, Lund, Pediatrics/Neonatology, Lund University, Lund, Sweden.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Kc', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15401'] 1718,32508341,"Combined effects of backward treadmill training and botulinum toxin type A therapy on gait and balance in patients with chronic stroke: A pilot, single-blind, randomized controlled trial.","BACKGROUND Backward walking is recommended to improve the components of physiological gait in neurological disease. Botulinum toxin type A is an effective safe first line-treatment for post-stroke spasticity. OBJECTIVE To compare the effects of backward treadmill training (BTT) versus standard forward treadmill training (FTT) on motor impairment in patients with chronic stroke receiving botulinum toxin type A therapy. METHODS Eighteen chronic stroke patients were randomly assigned to receive BTT (n = 7) or FTT (n = 11) as adjunct to botulinum toxin type A therapy. A total of twelve 40-minute sessions (3 sessions/week for 4 weeks) of either BTT or FTT were conducted. A blinded assessor evaluated the patients before and after treatment. The primary outcome was the 10-meter Walking Test (10 MWT). Secondary outcomes were the modified Ashworth Scale, gait analysis, and stabilometric assessment. RESULTS Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment. CONCLUSIONS Greater improvement in gait and balance was noted after BTT than after FTT as an adjunct to botulinum toxin therapy in patients with chronic stroke.",2020,"RESULTS Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment. ","['patients with chronic stroke receiving botulinum toxin type A therapy', 'Eighteen chronic stroke patients', 'patients with chronic stroke']","['BTT or FTT', 'BTT', 'backward treadmill training (BTT) versus standard forward treadmill training (FTT', 'backward treadmill training and botulinum toxin type', 'botulinum toxin type A therapy', 'Botulinum toxin type A', 'FTT', 'botulinum toxin therapy']","['length of CoP', 'stabilometric assessment [length of centre of pressure CoP', 'modified Ashworth Scale, gait analysis, and stabilometric assessment', '10\u200aMWT', '10-meter Walking Test (10\u200aMWT', 'gait and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",18.0,0.0763676,"RESULTS Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment. ","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serina', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Disarò', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Modenese', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203067'] 1719,32171767,Endothelial Safety and Efficacy of Ex Vivo Collagen Cross-linking of Human Corneal Transplants.,"PURPOSE To assess endothelial safety and efficacy of ex vivo corneal collagen cross-linking (CXL) in human corneal transplants stored in 2 different culture media. DESIGN Fellow-eye controlled laboratory study of ex vivo human donor corneas. METHODS Three sets of paired human donor corneas, 5 pairs each, were stored in organ culture medium before deswelling either at 31 C or at room temperature. One eye of each pair was cross-linked by 0.1% riboflavin in hydroxylpropyl methylcellulose (HPMC) instillation for 10 minutes followed by 10 minutes of ultraviolet-A (9 mW/cm 2 ) irradiation while contralateral eyes served as controls. In Set 1, endothelial cell densities were determined. In Set 2, paired samples were assigned to the 2 deswelling media and CXL efficacy was assessed comparing to untreated controls using collagenase-A-assisted enzymatic digestion. In Set 3, biomechanical testing was performed in the eye pairs (treated vs control) by stress/strain measurements. RESULTS There was no difference in endothelial cell counts between CXL samples and controls (P = .21). No statistically significant difference in digestion dynamics was found between tissues stored in the 2 different culture media. Complete enzymatic digestion was slowed down by 3 hours in the cross-linked samples (P = .036). Stress needed for a 12% strain was increased by 34% in the treatment group compared to control (P = .04). CONCLUSIONS Ex vivo CXL of human donor tissue is an effective and safe procedure with no difference regarding efficacy between 2 commercially available deswelling media. Biochemical and biomechanical resistance were significantly increased after CXL. Patients requiring keratoplasty owing to corneal melting might benefit from the strengthening effect of preoperative CXL of donor tissue.",2020,"Stress needed for a 12% strain was increased by 34% in the treatment group compared to control (P = .04). ","['Human Corneal Transplants', 'Three sets of paired human donor corneas, 5 pairs each, were stored in organ culture medium before deswelling either at 31 C or at room temperature', 'Fellow-eye controlled laboratory study of ex\xa0vivo human donor corneas', 'human corneal transplants stored in 2 different culture media']","['ex\xa0vivo corneal collagen cross-linking (CXL', 'riboflavin']","['Endothelial Safety and Efficacy', 'Stress needed for a 12% strain', 'digestion dynamics', 'Complete enzymatic digestion', 'Biochemical and biomechanical resistance', 'CXL efficacy', 'endothelial cell densities', 'endothelial cell counts', 'endothelial safety and efficacy']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0029205', 'cui_str': 'Organ Culture'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010454', 'cui_str': 'Culture medium'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}]",,0.0228488,"Stress needed for a 12% strain was increased by 34% in the treatment group compared to control (P = .04). ","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lammer', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria. Electronic address: jan.lammer@meduniwien.ac.at.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Laggner', 'Affiliation': 'Division of Thoracic Surgery, Medical University of Vienna, Vienna, Austria; Vienna Business Agency Project 2343727 ""APOSEC to Clinic"", Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Pircher', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Isaak', 'Initials': 'I', 'LastName': 'Fischinger', 'Affiliation': 'Department of Ophthalmology, Augentagesklinik Spreebogen Berlin, Berlin, Germany; Department of Ophthalmology, Johannes Kepler Universität, Kepler Universitätsklinikum Linz, Linz, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Hofmann', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Schmidinger', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.024'] 1720,32512272,Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis.,"INTRODUCTION Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective. METHODS A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups. RESULTS Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of $138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of $150,000 per QALY CONCLUSION: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies.",2020,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","['patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy', 'patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial', 'stage III non-small-cell lung cancer']","['durvalumab consolidation therapy', 'durvalumab', 'Durvalumab vs placebo consolidation therapy after chemoradiotherapy', 'placebo']","['total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'mean lifetime costs and effectiveness', 'OS rates', 'cost effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0947434,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, PR China. Electronic address: gongyouling@hotmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.011'] 1721,32512291,"Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease.","There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II-mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. METHODS: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2-infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). SUMMARY: The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2-infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.",2020,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"['hospitalized SARS-CoV-2-infected patients', 'hospitAlized patieNts with SARS-COV-2 Infection Disease', 'severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients', 'adult hospitalized SARS-CoV-2-infected patients (n = 651']","['valsartan', 'ARB valsartan', 'angiotensin receptor blockers (ARBs', 'placebo arm will receive matching placebo', 'placebo']","['occurrence of ICU admission, mechanical ventilation, and death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.592181,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"[{'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Sara-Joan', 'Initials': 'SJ', 'LastName': 'Pinto-Sietsma', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Konst', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Mensink', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Cortenbach', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Dominique V M', 'Initials': 'DVM', 'LastName': 'Verhaert', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Maxim J P', 'Initials': 'MJP', 'LastName': 'Rooijakkers', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Anouke', 'Initials': 'A', 'LastName': 'van Rumund', 'Affiliation': 'Department of Neurology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Biostatistics, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Hassing', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Jan-Hein', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Experimental Cardiology, UMCG, Groningen, the Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk-Noordergraaf', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2020.05.010'] 1722,32512314,Women's unmet needs in early labour: Qualitative analysis of free-text survey responses in the M@NGO trial of caseload midwifery.,"OBJECTIVE to analyse women's experiences of early labour care in caseload midwifery in Australia. DESIGN this study sits within a multi-site randomised controlled trial of caseload midwifery versus standard care. Participant surveys were conducted at 6-weeks and 6-months after birth. Free-text responses about experiences of care were subject to critical thematic analysis in NVivo 11 software. SETTING two urban Australian hospitals in different states. PARTICIPANTS women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial. INTERVENTIONS participants were randomised to caseload midwifery or standard care for antenatal, labour and birth and postpartum care. MEASUREMENTS AND FINDINGS The 6-week survey response rate was 58% (n = 1,019). The survey included five open questions about women's experiences of pregnancy, labour and birth, and postnatal care. Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories. The category of early labour contained data from 84 individual participants (caseload care n = 44; standard care n = 40). Descriptive themes were: (1) needing permission; (2) doing the 'wrong' thing; and (3) being dismissed. Analytic themes were: (1) Seeking: women wanting to be ""close to those who know what's going on""; and (2) Shielding: midwives defending resources and normal birth. KEY CONCLUSIONS Regardless of model of care, early labour care was primarily described in negative terms. This could be attributed to reporting bias, because women who were neutral about early labour care may not comment. Nevertheless, the findings demonstrate a gap in knowledge about early labour care in caseload midwifery models. IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.",2020,"IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","['two urban Australian hospitals in different states', 'Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories', '84 individual participants (caseload care n\xa0=\xa044; standard care n\xa0=\xa040', ""Women's unmet needs in early labour"", ""women's experiences of early labour care in caseload midwifery in Australia"", ""women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial""]","['caseload midwifery versus standard care', 'caseload midwifery or standard care for antenatal, labour and birth and postpartum care']","['pregnancy, labour and birth, and postnatal care']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]",,0.0808094,"IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","[{'ForeName': 'Jyai', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; School of Nursing and Midwifery, Griffith University, Meadowbrook, Queensland, Australia. Electronic address: jyai.allen@griffith.edu.au.'}, {'ForeName': 'Bec', 'Initials': 'B', 'LastName': 'Jenkinson', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia. Electronic address: bec.jenkinson@mater.uq.edu.au.'}, {'ForeName': 'Sally K', 'Initials': 'SK', 'LastName': 'Tracy', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia. Electronic address: sally.tracy@sydney.edu.au.""}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Hartz', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia; College of Nursing and Midwifery, Charles Darwin University, Sydney Campus, New South Wales, Australia. Electronic address: donna.hartz@cdu.edu.au.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': ""Department of Paediatrics and Child health Westmead Children's Clinical School, The University of Sydney, Westmead, New South Wales, Australia; Westmead Neonatal Intensive Care Unit, Westmead Hospital, Western Sydney Local Health District, New South Wales, Australia. Electronic address: mark.tracy@sydney.edu.au.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kildea', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; Molly Wardaguga Research Centre, College of Nursing and Midwifery, Charles Darwin University, Queensland, Australia. Electronic address: sue.kildea@cdu.edu.au.'}]",Midwifery,['10.1016/j.midw.2020.102751'] 1723,32512353,A Randomized Controlled Trial of Transcultural Validation of Group-Based Psychosocial Intervention for Patients with Bipolar Disorder.,"Adjunctive psychosocial interventions are part of the preferred method to treat bipolar disorder (BD). This study aimed to conduct a randomized control and protocol-guided trial, in order to evaluate the feasibility and effectiveness of adjunctive group-based treatments for Chinese outpatients with BD. A single-blind trial in which 68 outpatients with BD were randomly assigned to either treatment as usual (TAU) or to an experimental group with 12 additional weekly sessions and 3 monthly booster sessions. Participants were assessed at baseline for mood condition, suicidal ideation, medication adherence, and quality of life (QoL), with follow-up assessments every 3 months over a 1-year period. The overall retention rate of this study was 89.7%. The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed. The results of this study support the transcultural validity and efficacy of group-based psychosocial intervention as anadjunct to TAU among Chinese outpatients with BD to promote improvements during the course of the illness including achieving euthymia, reducing depressive symptoms, and improving QoL.",2020,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","['68 outpatients with BD', 'Patients with Bipolar Disorder', 'Chinese outpatients with BD']","['Adjunctive psychosocial interventions', 'psychosocial intervention', 'Group-Based Psychosocial Intervention']","['mood condition, suicidal ideation, medication adherence, and quality of life (QoL', 'medication adherence, reduction in manic symptoms, or suicidal ideation', 'feasibility and effectiveness', 'depression symptoms', 'transcultural validity and efficacy', 'depressive symptoms, and improving QoL', 'overall retention rate']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",68.0,0.0479467,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","[{'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Health and Welfare Policy, National Yang-Ming University.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Yang', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Taiwan Adventist Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-I', 'Initials': 'SI', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Audiology and Speech Language Pathology, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hung', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'I-Chieh', 'Initials': 'IC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'School of Medicine, Deakin University, Victoria, Australia.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan. Electronic address: maryliuyip@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113139'] 1724,32517382,Post-Exercise Recovery of Ultra-Short-Term Heart Rate Variability after Yo-Yo Intermittent Recovery Test and Repeated Sprint Ability Test.,"This study aimed to examine the agreement and acceptance of ultra-short-term heart rate (HR) variability (HRV UST ) measures during post-exercise recovery in college football players. Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study. The participants completed both a repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1) in a randomized order and separated by 7 days. Electrocardiographic signals (ECG) were recorded in a supine position 10 min before and 30 min after the exercise protocols. The HR and HRV data were analyzed in the time segments of baseline 5~10 min (Baseline), post-exercise 0~5 min (Post 1), post-exercise 5~10 min (Post 2), and post-exercise 25~30 min (Post 3). The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST and 5-min criterion (HRV criterion ) of each time segment. The correlation of time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio were calculated. The results showed that the HRV UST of LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio showed trivial to small effect sizes (ES) (-0.00~0.49), very large and nearly perfect interclass correlation coefficients (ICC) (0.74~0.95), and relatively small values of bias (RSA: 0.01~-0.12; YYIR1: -0.01~-0.16) to the HRV criterion in both exercise protocols. In addition, the HRV UST of LnLF, LnHF, and LnLF:LnHF showed trivial to small ES (-0.04~-0.54), small to large ICC (-0.02~0.68), and relatively small values of bias (RSA: -0.02~0.65; YYIR1: 0.03~-0.23) to the HRV criterion in both exercise protocols. Lastly, the 1-min LnSDNN:LnRMSSD ratio was significantly correlated to the 5-min LnLF:LnHF ratio with moderate~high level ( r = 0.43~0.72; p < 0.05) during 30-min post-exercise recovery. The post-exercise 1-min HRV assessment in LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio was acceptable and accurate in the RSA and YYIR1 tests, compared to the 5-min time segment of measurement. The moderate to high correlation coefficient of the HRV UST LnSDNN:LnRMSSD ratio to the HRV criterion LnLF:LnHF ratio indicated the capacity to facilitate the post-exercise shortening duration of HRV measurement after maximal anaerobic or aerobic shuttle running. Using ultra-short-term record of LnSDNN:LnRMSSD ratio as a surrogate for standard measure of LnLF:LnHF ratio after short-term bouts of maximal intensity field-based shuttle running is warranted.",2020,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST and 5-min criterion (HRV criterion ) of each time segment.","['college football players', 'Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study']",['repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1'],"['natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio', 'Electrocardiographic signals (ECG', 'agreement and acceptance of ultra-short-term heart rate (HR) variability', 'HRV UST ) measures', 'HR and HRV data', 'time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517489', 'cui_str': '1.08'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",25.0,0.0701879,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST and 5-min criterion (HRV criterion ) of each time segment.","[{'ForeName': 'Chin-Hwai', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Chien', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Crowley-McHattan', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Lismore 2480, Australia.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17114070'] 1725,32228137,The Effects of Expert and Augmented Feedback on Learning a Complex Medical Skill.,"Many medical skills are complex due to their requirements for integration of declarative (biomedical) knowledge with perceptual-motor and perceptual-cognitive proficiency. While feedback generally helps learners guide their actions, it is unclear how feedback supports the integration of declarative knowledge with skills. Thus, we investigated the effect of expert and augmented feedback on acquisition and retention of a complex medical skill (acquiring a transthoracic echocardiogram) in a simulation study. We randomly assigned 36 medical undergraduate students to one of three feedback sources: Expert (EF), Augmented visual (HS), and Expert plus Help Screen (EF + HS). Participants practiced until reaching proficiency. Outcome measures (knowledge test and practical skill ratings on a 5-point scale), were gathered at initial acquisition and at retention after 11 days, the time needed to obtain the images and the quality of images obtained. We divided the knowledge test into three topics: names of the images, manipulation of the probe, and anatomy of the heart. At acquisition, immediately after training, EF group participants were faster at obtaining images than participants in the two other groups. On the retention test, there were no group differences for speed of obtaining images, but the EF + HS group scored significantly higher than the other two groups on image quality. Thus, expert feedback best assisted initial acquisition and combined augmented and expert feedback best assisted retention of this complex medical task. Expert assistance reduced learners' cognitive load during initial practice, helping learners integrate declarative knowledge with physical skills.",2020,"On the retention test, there were no group differences for speed of obtaining images, but the EF + HS group scored significantly higher than the other two groups on image quality.",['36 medical undergraduate students to one of three'],"['feedback sources: Expert (EF), Augmented visual (HS), and Expert plus Help Screen (EF\u2009+\u2009HS', 'Expert and Augmented Feedback']","['time needed to obtain the images and the quality of images obtained', 'Outcome measures (knowledge test and practical skill ratings on a 5-point scale']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",36.0,0.0200039,"On the retention test, there were no group differences for speed of obtaining images, but the EF + HS group scored significantly higher than the other two groups on image quality.","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cecilio-Fernandes', 'Affiliation': 'Center for Education Development and Research in Health Professions, research group LEARN, University of Groningen and University Medical Center Groningen.'}, {'ForeName': 'Fokie', 'Initials': 'F', 'LastName': 'Cnossen', 'Affiliation': 'Institute of Artificial Intelligence and Cognitive Engineering, University of Groningen.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Coster', 'Affiliation': 'Department of Cardiology, University of Groningen and University Medical Center Groningen.'}, {'ForeName': 'Ad Debbie C', 'Initials': 'ADC', 'LastName': 'Jaarsma', 'Affiliation': 'Center for Education Development and Research in Health Professions, research group LEARN, University of Groningen and University Medical Center Groningen.'}, {'ForeName': 'René A', 'Initials': 'RA', 'LastName': 'Tio', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.'}]",Perceptual and motor skills,['10.1177/0031512520914680'] 1726,32521324,"Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.","OBJECTIVE To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities. METHODS Prospective, randomized, controlled, open, 12-month trial (NCT02374749). PARTICIPANTS consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group). MAIN OUTCOME change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management). RESULTS 502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). CONCLUSIONS AND RELEVANCE This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.",2020,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). ","['consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM', 'patients with axial spondyloarthritis', '502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y', 'young population of patients with axSpA']","['nurse-led program of systematic screening', 'nurse-led program', 'single-visit nurse-led program']",['weighted comorbidity management score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",502.0,0.0692749,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France. Electronic address: anna.molto@aphp.fr.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM, Paris France; Pitié Salpêtrière hospital, APHP, Rheumatology department, Paris, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, F-94010, Créteil, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, Toulouse, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale, Paris, France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU Brest, LabEx IGO, Brest, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.012'] 1727,32521358,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. METHODS The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. ETHICS AND DISSEMINATION The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132'] 1728,32521394,Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.,"OBJECTIVE Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty. PATIENTS AND METHODS Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device. RESULTS VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups. CONCLUSIONS Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.",2020,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","['patients undergoing posterior spinal fusion surgery', 'Eighty patients who underwent posterior spinal fusion', 'patients undergoing posterior lumbar spinal fusion surgery']","['Perioperative magnesium sulfate infusion', 'magnesium and saline', 'magnesium', 'perioperative magnesium sulfate infusion']","['postoperative analgesia', 'intraoperative bleeding', 'Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen', 'morphine consumption', 'cell count, magnesium concentration and coagulation status', 'Morphine consumption', 'intraoperative blood loss', 'pain score', 'activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT', 'Cumulative PCA morphine consumption', 'intraoperative blood loss and postoperative analgesia', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",80.0,0.140799,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","[{'ForeName': 'Masih Ebrahimy', 'Initials': 'ME', 'LastName': 'Dehkordy', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Tavanaei', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Younesi', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khorasanizade', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza Azizi', 'Initials': 'HA', 'LastName': 'Farsani', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraee-Yazdani', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Saeed_o_yazdani@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105983'] 1729,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended. METHOD To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website. RESULTS Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). CONCLUSION Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). ",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). ","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177'] 1730,32521472,Improvement of dynamic postural stability by an exercise program.,"BACKGROUND Central processing of multi-sensory feedback and motor commands responsible for force production are critical for postural control. An exercise program was developed to realign spinal curvature, but its effect on postural control is unknown. RESEARCH QUESTION To what extent would the exercise program influence on center of pressure (CoP) sway on stable and unstable surfaces? METHODS Subjects (n = 30) were randomly assigned into one of three groups: exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n = 10), exercise on a flat surface (n = 10), and a control group that laid supine on a flat surface (n = 10). Standing posture of each subject was quantified using anterior-, posterior-, and lateral-view photography. Each subject's CoP sway was measured while standing on a static and dynamic platform with eyes open and eyes closed. Subjects were instructed to stand still when the platform was held stationary (e.g., no tilt) during the static condition. During the dynamic condition the platform was allowed to tilt in response to changes of CoP and subjects were instructed to maintain the platform in a horizontal position. RESULTS Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). SIGNIFICANCE It is speculated that performing the exercise program on the tube might enhance a) central processing of somatosensory and vestibular inputs, b) motor commands responsible for force production in postural control, and c) biomechanical advantage by the realigned posture. The exercise program can be used by a variety of populations as home-exercise to realign the neck and pelvic posture and improve dynamic postural stability.",2020,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). ",['Subjects (n\u202f=\u202f30'],"['exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n\u202f=\u202f10), exercise on a flat surface (n\u202f=\u202f10), and a control group that laid supine']","['dynamic postural stability', 'neck flexion and pelvis tilt decreased, and CoP sway']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0135493,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). ","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibata', 'Affiliation': 'Athletic Training Education Program, Department of Health Exercise and Sports Sciences, University of New Mexico, New Mexico, USA. Electronic address: diceshibata@unm.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.044'] 1731,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers. METHODS A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study. RESULTS Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups. CONCLUSIONS Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT02629289 (C1221001); NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x'] 1732,32524500,"Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis.","INTRODUCTION The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients. METHODS Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed. RESULTS Of 1718 total enrolled patients, 196 Asian patients (denosumab, n = 103; zoledronic acid, n = 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively. CONCLUSION Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov NCT01345019.",2020,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","['Newly Diagnosed Multiple Myeloma', 'adults with newly diagnosed multiple myeloma (MM', 'Asian patients', 'Patients', 'Asian patients with newly diagnosed MM with lytic bone lesions', '1718 total enrolled patients, 196 Asian patients (denosumab, n\u2009=\u2009103; zoledronic acid, n\u2009=\u200993', 'All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE']","['standard-of-care first-line antimyeloma treatment', 'zoledronic acid', 'Denosumab Versus Zoledronic Acid', 'denosumab versus zoledronic acid', 'denosumab 120\xa0mg subcutaneously or zoledronic acid']","['diarrhea', 'skeletal-related events (SREs', 'treatment-emergent hypocalcemia', 'renal toxicity', 'pyrexia', 'efficacy and safety', 'Efficacy and safety outcomes', 'crude incidence of SREs', 'nausea']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",196.0,0.620923,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","[{'ForeName': 'Shang-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Wee Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore, National University Health System, Singapore, Republic of Singapore.'}, {'ForeName': 'Cheng-Shyong', 'Initials': 'CS', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Raymond Siu-Ming', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Sir Y.K. Pao Centre for Cancer and Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Seasea', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Gordon', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Glennane', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Department of Hematology, Seoul St. Mary's Hospital, Seoul, Republic of Korea. ckmin@catholic.ac.kr.""}]",Advances in therapy,['10.1007/s12325-020-01395-x'] 1733,32525036,"One layer or two: Does it matter when performing a handsewn bowel anastomosis? Invited Commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastamosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.075286,,"[{'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA. Electronic address: gwakam@med.umich.edu.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.088'] 1734,32131146,Washing with water alone versus soap in maintaining remission of eczema.,"BACKGROUND There is no consensus on the use of soap in skin care for atopic dermatitis in Japan. Thus, this study aimed to evaluate the efficacy of soap to maintain eczema remission in atopic dermatitis patients during the fall-winter period in Japan. METHODS This assessor-blinded, pragmatic randomized, non-inferiority study enrolled atopic dermatitis patients whose eczema was controlled by regular steroid ointment application less than or equal to 2 days / week (tacrolimus ointment was permitted). For 8 ± 3 weeks, participants washed their upper and lower limbs on one side with soap (soap side) and on the other side with water alone (water side). The primary outcome was an Eczema Area and Severity Index score at week 8 ± 3. RESULTS Twenty-nine participants were analyzed. The Eczema Area and Severity Index scores at week 8 ± 3 of the water and soap sides were 0.0 (0.0-0.4) and 0.0 (0.0-0.4), respectively (P = 0.18). The difference between both sides was -0.02 (-0.11-0.08), and the limits of the 95% confidence interval did not reach the prespecified non-inferiority margin. The average Patient-Oriented Eczema Measure score was 1.27 ± 1.7 and 1.32 ± 1.8 for the water and soap sides, respectively (P = 0.92). The total number of additional steroid ointment applications was four (0-20) times and six (0-23) times, respectively (P = 0.98). Participants were categorized according to self-assessments of the usefulness of soap, with 2, 24, and 3 participants in the water-effective, invariant, and soap-effective groups, respectively. CONCLUSIONS For children with controlled atopic dermatitis, washing with water alone was not inferior to washing with soap for maintaining remission of eczema during the fall-winter period in Japan.",2020,"For children with controlled atopic dermatitis, washing with water alone was not inferior to washing with soap for maintaining remission of eczema during the fall-winter period in Japan.","['atopic dermatitis patients during the fall-winter period in Japan', 'Twenty-nine participants were analyzed', 'atopic dermatitis patients whose eczema was controlled by regular', 'children with controlled atopic dermatitis', 'atopic dermatitis in Japan']","['soap', 'steroid ointment application within 2 days/week (tacrolimus ointment', 'Washing with Water Alone versus Soap']","['Eczema Area and Severity Index scores', 'Eczema Area and Severity Index score', 'average Patient-Oriented Eczema Measure score', 'total number of additional steroid ointment applications']","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4304940', 'cui_str': 'Patient-Oriented Eczema Measure score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",29.0,0.0508418,"For children with controlled atopic dermatitis, washing with water alone was not inferior to washing with soap for maintaining remission of eczema during the fall-winter period in Japan.","[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Inuzuka', 'Affiliation': 'Division of Pediatrics, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Natsume', 'Affiliation': 'Division of Pediatrics, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Matsunaga', 'Affiliation': 'Division of Pediatrics, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Monna', 'Affiliation': 'Division of Pediatrics, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Eisaku', 'Initials': 'E', 'LastName': 'Okada', 'Affiliation': 'Division of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Division of Pediatrics, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Taguchi', 'Affiliation': 'Division of Pediatrics, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14216'] 1735,32497520,"39·0°C versus 38·5°C ear temperature as fever limit in children with neutropenia undergoing chemotherapy for cancer: a multicentre, cluster-randomised, multiple-crossover, non-inferiority trial.","BACKGROUND Fever in neutropenia is the most frequent complication of chemotherapy for cancer. The temperature limit defining fever used clinically varies. A higher limit can avoid unnecessary diagnoses in patients spontaneously recovering from fever. This trial primarily aimed to determine if a limit of 39·0°C ear temperature is non-inferior to 38·5°C regarding safety. METHODS This cluster-randomised, multiple crossover, non-blinded, non-inferiority trial was done in six Swiss Paediatric Oncology Group centres (clusters) in Switzerland. Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5°C ear temperature limits for diagnosis of fever in neutropenia. Diagnosis below the randomised limit was allowed for clinical reasons. Such a diagnosis implied emergency hospitalisation, examinations (including blood culture), as-needed antipyretics, and empirical intravenous broad-spectrum antibiotics. The primary outcome was the rate of fever in neutropenia with safety relevant events (SRE) per chemotherapy year; we also assessed efficacy in terms of rate of fever in neutropenia. The non-inferiority margin was 1·33 for safety, and for effiacy, the superiority margin was 1·00. This trial is registered at ClinicalTrials.gov, number NCT02324231. FINDINGS 269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis. Patients were repeatedly randomly assigned, with 1210 (48%) of 2547 randomisation periods and 92 (47%) of 195 chemotherapy years randomised to 39·0°C. SREs were diagnosed in 72 (20%) of 360 fever in neutropenia episodes (zero deaths, 16 intensive care unit admissions, 22 cases of severe sepsis, and 56 cases of bacteraemia). In 92 chemotherapy years randomised to the 39·0°C fever limit, 151 episodes of fever with neutropenia were diagnosed (1·64 per year), including 22 (15%) with SRE (0·24 per year). In 103 chemotherapy years randomised to 38·5°C, 209 episodes were diagnosed (2·03 per year), including 50 (24%) with SRE (0·49 per year). The mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE in 39·0°C versus 38·5°C was 0·56 (95% upper confidence bound 0·72). The corresponding RR of fever in neutropenia was 0·83 (95% upper confidence bound 0·98). INTERPRETATION In children with neutropenia and chemotherapy for cancer, 39·0°C ear temperature was safe and seemed efficacious. For Switzerland and comparable settings, 39·0°C can be recommended as new evidence-based standard fever limit except for patients with acute myeloid leukaemia or haematopoietic stem cell transplantation. FUNDING Swiss Cancer League (KLS-3645-02-2015).",2020,The corresponding RR of fever in neutropenia was 0·83,"['patients spontaneously recovering from fever', 'children with neutropenia undergoing chemotherapy for cancer', '269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis', '103 chemotherapy years randomised to 38·5', 'six Swiss Paediatric Oncology Group centres (clusters) in Switzerland', 'patients with acute myeloid leukaemia or haematopoietic stem cell transplantation', 'Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5']",[],"['rate of fever in neutropenia', 'fever with neutropenia', 'mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE', 'SREs', 'corresponding RR of fever in neutropenia', 'rate of fever in neutropenia with safety relevant events (SRE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",269.0,0.380971,The corresponding RR of fever in neutropenia was 0·83,"[{'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Koenig', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bodmer', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Philipp K A', 'Initials': 'PKA', 'LastName': 'Agyeman', 'Affiliation': 'Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Niggli', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Adam', 'Affiliation': 'Unit of Pediatric Hematology-Oncology, Woman-Mother-Child Department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, University Hospital of Geneva, Geneva, Switzerland; Department of Paediatrics, CANSEARCH Research Laboratory, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Eisenreich', 'Affiliation': ""Department of Pediatric Oncology and Hematology, Children's Hospital Lucerne, Lucerne, Switzerland.""}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Keller', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Leibundgut', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nadal', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Roessler', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Scheinemann', 'Affiliation': ""Division of Pediatric Hematology and Oncology, Department of Pediatrics, Kantonsspital Aarau, Aarau, Switzerland; Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland; Department of Pediatrics, McMaster Children's Hospital and McMaster University, Hamilton, ON, Canada.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital Medical Centre, University Hospital of Saarland, Homburg, Germany.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Teuffel', 'Affiliation': 'University of Tuebingen, Tuebingen, Germany; Division of Oncology, Medical Services of the Statutory Health Insurance, Baden-Wuerttemberg, Germany.'}, {'ForeName': 'Nicolas X', 'Initials': 'NX', 'LastName': 'von der Weid', 'Affiliation': ""Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeller', 'Affiliation': 'Swiss Paediatric Oncology Group, Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Zimmermann', 'Affiliation': ""Children's Research Centre, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland; Department Public Health-Nursing Science, Faculty of Medicine, University Basel, Basel, Switzerland.""}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Ammann', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: roland.ammann@insel.ch.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30092-4'] 1736,32506665,The association between serum sex steroid hormone concentrations and intraprostatic inflammation in men without prostate cancer and irrespective of clinical indication for biopsy in the placebo arm of the Prostate Cancer Prevention Trial.,"BACKGROUND Intraprostatic inflammation is an emerging prostate cancer risk factor. Estrogens are pro-inflammatory while androgens are anti-inflammatory. Thus, we investigated whether serum sex steroid hormone concentrations are associated with intraprostatic inflammation to inform mechanistic links among hormones, inflammation, and prostate cancer. METHODS We conducted a cross-sectional study among 247 men in the placebo arm of the Prostate Cancer Prevention Trial who had a negative end-of-study biopsy, most (92.7%) performed without clinical indication per trial protocol. Serum estradiol, estrone, and testosterone were previously measured by immunoassay in pooled baseline and Year 3 serum. Free estradiol and free testosterone were calculated. Inflammation was visually assessed (median of three prostate biopsy cores per man). Polytomous or logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (CI) of some or all cores inflamed (both vs none) or any core inflamed (vs none) by hormone tertile, adjusting for age, race, and family history. We evaluated effect modification by waist circumference and body mass index (BMI). RESULTS In all, 51.4% had some and 26.3% had all cores inflamed. Free (P-trend = .11) but not total estradiol was suggestively inversely associated with all cores inflamed. In men with waist circumference greater than or equal to 102 cm (P-trend = .021) and BMI ≥ 27.09 kg/m 2 (P-trend = .0037) free estradiol was inversely associated with any core inflamed. Estrone was inversely associated with all cores inflamed (T3: OR = 0.36, 95% CI 0.14-0.95, P-trend = .036). Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05) testosterone were positively associated with any core inflamed, especially free testosterone in men with waist circumference less than 102 cm (T3: OR = 3.51, 95% CI 1.03-12.11, P-trend = .05). CONCLUSIONS In this first study in men without prostate cancer and irrespective of clinical indication for biopsy, contrary to the hypothesis, circulating estrogens appeared to be inversely associated, especially in heavy men, whereas androgens appeared to be positively associated with intraprostatic inflammation.",2020,"Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05)","['247 men in the placebo arm of the Prostate Cancer Prevention Trial who had a negative end-of-study biopsy, most (92.7%) performed without clinical indication per trial protocol', 'men without prostate cancer']",[],"['Free estradiol and free testosterone', 'testosterone', 'Inflammation', 'total estradiol', 'waist circumference and body mass index (BMI', 'Serum estradiol, estrone, and testosterone', 'Estrone']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]",[],"[{'cui': 'C0369189', 'cui_str': 'Free estradiol'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",247.0,0.209464,"Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05)","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chadid', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Barber', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Nelson', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Gurel', 'Affiliation': 'The Institute of Cancer Research, The Royal Marsden, London, UK.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'The Cancer Therapy and Research Center, CHRISTUS Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'Departments of Obstetrics and Gynecology, and Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Lippman', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Platz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",The Prostate,['10.1002/pros.24023'] 1737,32509046,Ultrasound-Guided Inactivation of Trigger Points Combined with Muscle Fascia Stripping by Liquid Knife in Treatment of Postherpetic Neuralgia Complicated with Abdominal Myofascial Pain Syndrome: A Prospective and Controlled Clinical Study.,"Objective To evaluate ultrasound-guided inactivation of myofascial trigger points (MTrPs) combined with abdominal muscle fascia stripping by liquid knife in the treatment of postherpetic neuralgia (PHN) complicated with abdominal myofascial pain syndrome (AMPS). Methods From January 2015 to July 2018, non-head-and-neck PHN patients in the Pain Department, The First Affiliated Hospital of Soochow University, were treated with routine oral drugs and weekly paraspinal nerve block for two weeks. Patients with 2 < VAS (visual analogue scale) score < 6 were subjects of the study. They were assigned into control group 1 (C1, n  = 33) including those with PHN and without myofascial pain syndrome (MPS) and control group 2 (C2, n  = 33) including those with PHN complicated with MPS and observation group 1 (PL, n  = 33) including those with PHN complicated with limb myofascial pain syndrome (LMPS) and observation group 2 (PA, n  = 33) including those with PHN complicated with AMPS. All groups received zero-grade treatment: routine oral drugs and weekly paraspinal nerve block. PL and PA groups were also treated step by step once a week: primary ultrasound-guided inactivation of MTrPs with dry needling, secondary ultrasound-guided inactivation of MTrPs with dry and wet needling, and tertiary ultrasound-guided dry and wet needling combined with muscle fascia stripping by liquid knife. At one week after primary treatment, patients with a VAS score > 2 proceeded to secondary treatment. If the VAS score was <2, the treatment was maintained, and so on, until the end of the four treatment cycles. Pain assessment was performed by specialized nurses at one week after each treatment, including VAS score, McGill pain questionnaire (MPQ) score, pressure pain sensory threshold (PPST), and pressure pain tolerance threshold (PPTT). VAS score was used as the main index and VAS <2 indicated effective treatment. At 3 months after treatment, outpatient and/or telephone follow-up was performed. The recurrence rate was observed and VAS > 2 was regarded as recurrence. Results At one week after primary treatment, the effective rate was 66.7% in PL group, significantly higher than that in PA group (15.2%, P < 0.05). At one week after secondary treatment, the effective rate was 100% and 37.5% in PL and PA groups, respectively, with significant difference between the groups ( P < 0.05). The effective rate increased to 90.6% in PA group at one week after tertiary treatment. At one week after the end of treatment cycles, the scores of VAS and MPQ were significantly lower in C1, PL, and PA groups than in C2 group ( P < 0.05), while PPST and PPTT were significantly higher than in C2 group ( P < 0.05). There was no significant difference between C1 group and PL group ( P > 0.05). At follow-up at 3 months after treatment, the recurrence rate was low in each group, with no significant difference between the groups ( P > 0.05). Conclusion About 57% of PHN patients with mild to moderate pain are complicated with MPS, and ultrasound-guided inactivation of MTrPs with dry and wet needling can effectively treat PHN patients complicated with LMPS. However, patients with PHN complicated with AMPS need to be treated with ultrasound-guided MTrPs inactivation combined with muscle fascia stripping by liquid knife as soon as possible.",2020,"At follow-up at 3 months after treatment, the recurrence rate was low in each group, with no significant difference between the groups ( P > 0.05). ","['Patients with 2\u2009<\u2009VAS (visual analogue scale) score < 6 were subjects of the study', 'postherpetic neuralgia (PHN) complicated with abdominal myofascial pain syndrome (AMPS', 'Postherpetic Neuralgia Complicated with Abdominal Myofascial Pain Syndrome', 'From January 2015 to July 2018, non-head-and-neck PHN patients in the Pain Department, The First Affiliated Hospital of Soochow University', 'patients with PHN complicated with AMPS']","['ultrasound-guided inactivation of myofascial trigger points (MTrPs) combined with abdominal muscle fascia stripping by liquid knife', 'Muscle Fascia Stripping by Liquid Knife', 'PHN and without myofascial pain syndrome (MPS) and control group 2 (C2, n \u2009=\u200933) including those with PHN complicated with MPS and observation group 1 (PL, n \u2009=\u200933) including those with PHN complicated with limb myofascial pain syndrome (LMPS) and observation group 2 (PA, n \u2009=\u200933) including those with PHN complicated with AMPS', 'ultrasound-guided MTrPs inactivation combined with muscle fascia stripping by liquid knife', 'Ultrasound-Guided Inactivation of Trigger Points', 'primary ultrasound-guided inactivation of MTrPs with dry needling, secondary ultrasound-guided inactivation of MTrPs with dry and wet needling, and tertiary ultrasound-guided dry and wet needling combined with muscle fascia stripping by liquid knife', 'zero-grade treatment: routine oral drugs and weekly paraspinal nerve block']","['VAS score', 'VAS score, McGill pain questionnaire (MPQ) score, pressure pain sensory threshold (PPST), and pressure pain tolerance threshold (PPTT', 'scores of VAS and MPQ', 'effective rate', 'Pain assessment', 'recurrence rate', 'PPST and PPTT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C0185460', 'cui_str': 'Stripping of fascia'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442145', 'cui_str': 'Paraspinal'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4305047', 'cui_str': 'McGill Pain Questionnaire score'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036677', 'cui_str': 'Sensory threshold'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0157686,"At follow-up at 3 months after treatment, the recurrence rate was low in each group, with no significant difference between the groups ( P > 0.05). ","[{'ForeName': 'Xiang-Hong', 'Initials': 'XH', 'LastName': 'Lu', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Xiao-Lan', 'Initials': 'XL', 'LastName': 'Chang', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Si-Lan', 'Initials': 'SL', 'LastName': 'Liu', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Jing-Ya', 'Initials': 'JY', 'LastName': 'Xu', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Gou', 'Affiliation': 'Central Laboratory, Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai, Shanghai 201999, China.'}]",Pain research & management,['10.1155/2020/4298509'] 1738,32505861,The affect of goserelin on the QoL of women having chemotherapy for EBC: Results from the OPTION trial.,"BACKGROUND The OPTION trial results showed that premenopausal women with early stage breast cancer (EBC) receiving chemotherapy benefited from ovarian function protection with goserelin. The impact of treatments on patient reported Quality of Life (QoL) were also examined. PATIENTS AND METHODS 227 pre-menopausal women with EBC, were randomly assigned to chemotherapy±goserelin (C±G); 132 (58%) were ER-ve. Patients were stratified by age (≤40 years and >40 years). QoL was assessed with the Functional Assessment of Cancer Therapy - Breast, and Endocrine Symptom checklist at baseline (pre-treatment), 3, 6, 12, 18 and 24 months, then annually to 5 years. Treatment Outcome Index (TOI) score was the primary outcome. RESULTS 213 patients were available for QoL analysis. There was a significant decrease in TOI scores for both treatment groups at 3 and 6 months that returned to pre-treatment levels at 12 months, then continued to increase reflecting improved QoL. By 3 months there was a significant difference from baseline in both groups for menopausal symptoms, and between groups in the proportion experiencing hot flushes at any time. The C + G group experienced higher levels of vasomotor symptoms generally during the treatment phase; by 24 months, the short-term negative effect of goserelin was reversed, with hot flushes twice as frequent in the chemotherapy only group (40.9% vs 21.3%). CONCLUSIONS These results show that young women diagnosed with breast cancer experienced only a short-term decrease in QoL from the addition of goserelin, in order to preserve ovarian function during chemotherapy treatment.",2020,"There was a significant decrease in TOI scores for both treatment groups at 3 and 6 months that returned to pre-treatment levels at 12 months, then continued to increase reflecting improved QoL. By 3 months there was a significant difference from baseline in both groups for menopausal symptoms, and between groups in the proportion experiencing hot flushes at any time.","['213 patients were available for QoL analysis', 'Patients were stratified by age (≤40 years and >40 years', 'women having chemotherapy for EBC', '227 pre-menopausal women with EBC', 'young women diagnosed with breast cancer', 'premenopausal women with early stage breast cancer (EBC) receiving']","['chemotherapy', 'chemotherapy±goserelin (C±G', 'goserelin']","['Functional Assessment of Cancer Therapy - Breast, and Endocrine Symptom checklist', 'Quality of Life (QoL', 'ovarian function', 'vasomotor symptoms', 'TOI scores', 'Treatment Outcome Index (TOI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",213.0,0.103562,"There was a significant decrease in TOI scores for both treatment groups at 3 and 6 months that returned to pre-treatment levels at 12 months, then continued to increase reflecting improved QoL. By 3 months there was a significant difference from baseline in both groups for menopausal symptoms, and between groups in the proportion experiencing hot flushes at any time.","[{'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'R', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, United Kingdom.'}, {'ForeName': 'Yellowlees', 'Initials': 'Y', 'LastName': 'A', 'Affiliation': 'Quantics Consulting Ltd, Edinburgh, United Kingdom.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'J', 'Affiliation': ""Department of Oncology, Guy's and St Thomas' NHS Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Fallowfield', 'Initials': 'F', 'LastName': 'L', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE -C) University of Sussex, United Kingdom.'}, {'ForeName': 'Jenkins', 'Initials': 'J', 'LastName': 'V', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE -C) University of Sussex, United Kingdom. Electronic address: val@sussex.ac.uk.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.05.009'] 1739,32505866,"Compared to Facebook, Instagram use causes more appearance comparison and lower body satisfaction in college women.","The current experiment tested the effect of social media use on college women's appearance comparisons, mood, and body satisfaction. We randomly assigned 308 undergraduate women (aged 18-26) to use Facebook, use Instagram, or play a matching game (the control condition) on an iPad for seven minutes. Compared to the Facebook condition, Instagram users retrospectively reported spending more time viewing images or videos containing people. Participants in both the Facebook and Instagram conditions also retrospectively reported engaging in more appearance comparisons relative to those in the control condition, but Instagram users reported significantly more appearance comparisons than those in the Facebook condition. Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect. Results are consistent with previous research suggesting social media use influences body satisfaction and social comparison, and that Instagram may be a particularly harmful platform when it comes to body image because of its focus on photos over text.",2020,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[""college women's"", '308 undergraduate women (aged 18-26) to use', 'college women']","['Facebook, use Instagram, or play a matching game (the control condition']","['body satisfaction', 'appearance comparisons, mood, and body satisfaction']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",308.0,0.0383295,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Engeln', 'Affiliation': 'Department of Psychology, Northwestern University, United States. Electronic address: rengeln@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Loach', 'Affiliation': 'Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Imundo', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zola', 'Affiliation': 'Oxford Internet Institute, University of Oxford, United Kingdom.'}]",Body image,['10.1016/j.bodyim.2020.04.007'] 1740,32505867,Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators are equivalent in the assessment of photosensitivity: Clinical and research implications.,"The assessment of the effect of photic stimulation is an integral component of an EEG exam and is especially important in patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy. A positive test result relies on eliciting a specific abnormality defined as the ""photoparoxysmal response"". Reliability of this assessment is strongly influenced by technical and procedural variables, a critical one represented by the physical properties of the stimulators used. Established clinical norms are based on data acquired with the ""gold-standard"" Grass PS stimulators. These are no longer commercially available and have been replaced by stimulators using light emitting diode (LED) technology. To our knowledge no comparative study on their efficacy has been conducted. To address this gap, we recruited 39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity in a prospective randomized single-blind cross-over study to compare two commercially available LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device. Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.",2020,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"['39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity', 'patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy']","['Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators', 'LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device', 'photic stimulation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0014548', 'cui_str': 'Generalized epilepsy'}, {'cui': 'C0349506', 'cui_str': 'Photosensitivity'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]",[],39.0,0.0265254,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"[{'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center Utrecht, Utrecht, the Netherlands; Nesmos Department, Faculty of Medicine and Psychology, Sapienza University, Roma, Italy.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Checa-Ros', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK; Department of Pediatrics, Faculty of Medicine, University of Granada, Spain.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Seri', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK. Electronic address: s.seri@aston.ac.uk.""}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106377'] 1741,32505932,Audiological assessment of neonatal hyperbilirubinemia.,"OBJECT To evaluate the hearing of infants with history of neonatal hyperbilirubinemia using ABR. METHODS A prospective randomized study carried on 100 infants whose hearing was assessed by ABR. Infants were allocated into two groups; case group which involve 60 infants with history of neonatal hyperbilirubinemia (bilirubin more than17 mg/dl and less than 30 mg/dl) and control group involve 40 healthy infants. Each group was divided into 3 groups based on their age i.e. ≤ 6 months, > 6-9 months &> 9-12 months. The evaluated variables were latency time & inter peak latency time. RESULTS The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave I did not show a significant difference between the two study groups (P > 0.05). The mean inter wave latencies I-III, I-V& III-V of ABR were significantly higher in the case group compared with the controls. There was a negative correlation between age and the studied variables. CONCLUSION Hyperbilirubinemia have an adverse effect on neonatal hearing which was reflected by ABR parameters of this study.",2020,The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave,"['40 healthy infants', '60 infants with history of neonatal hyperbilirubinemia (bilirubin more than17', 'neonatal hyperbilirubinemia', '100 infants whose hearing was assessed by ABR', 'hearing of infants with history of neonatal hyperbilirubinemia using ABR']",[],"['mean latencies of wave III&V of ABR', 'mean latencies of wave', 'mean inter wave latencies I-III, I-V& III-V of ABR', 'latency time & inter peak latency time']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",100.0,0.0141002,The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave,"[{'ForeName': 'Yasser Mohammad', 'Initials': 'YM', 'LastName': 'Mandour', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: ghader_massoud@yahoo.com.'}, {'ForeName': 'Mohamed Aly', 'Initials': 'MA', 'LastName': 'El Sayed', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: drmohamedalyelsayed@yahoo.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'El Sayed Morgan', 'Affiliation': 'Faculty of Medicine, Department of Audio Vestibular Medicine, Mansoura University, Mansoura Faculty of Medicine, Egypt. Electronic address: ashraf_morgan75@yahool.com.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Bassam', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: ghadeer_masoud@yahoo.com.'}, {'ForeName': 'Hamada', 'Initials': 'H', 'LastName': 'Fadl', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: fadl_hamada@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elrefae', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: refae_ahmed@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110126'] 1742,32516744,Evaluation of factors influencing obesity and the effect of a 12-week home-based exercise program in people with epilepsy - Randomized control trial.,"BACKGROUND Association of obesity, quality of life (QoL), and physical fitness in people with epilepsy (PWE) is rarely reported. We evaluate the effect of a 12-week home-based exercise program on weight reduction and physical capacity in PWE. METHODS In 173 PWE, physical fitness was assessed by using six-minute walk test (6MWT) and one-minute step test. Self-reported QoL data was collected using a 12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores were derived. Effect of exercise was evaluated using randomized study of 110 PWE, divided into control and exercise groups of 55 each. RESULTS At baseline, mean age of study population was 25.85 ± 9.62 years with 77 (44.5%) women. Average body mass index (BMI) was 29.33 ± 6.17 kg/m 2 . Mean PCS and MCS were 45.95 ± 7.92 and 45.72 ± 10.40 respectively. In 124 (71.7%) PWE with obesity, while high-density lipoprotein (HDL-C) (46.10 ± 12.32 vs. 39.30 ± 10.39 mg/dL; p < .001) was lower, low-density lipoprotein (LDL-C) (101.60 ± 37.51 vs. 113.89 ± 32.65 mg/dL; p = .035) was high. Both the randomized groups were comparable for type and number of antiepileptic drugs (AEDs) used. At 12-week follow-up, PWE in the exercise group reduced 7.65 ± 5.62 kg while control group gained an average of 4.01 ± 4.74 kg (p < .001). Distance walked in 6MWT (293.07 ± 118.73 vs. 464.29 ± 55.33 m; p = .007) and PCS (48.59 ± 8.57 vs. 52.62 ± 4.03; p = .006) were higher in exercise group whereas MCS did not differ between the groups. None of the participants reported seizure during the 12-week follow-up period. CONCLUSION People with epilepsy have low PCS and MCS scores; PWE with obesity have altered metabolic profile when compared to PWE without obesity. A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used. Trials with larger sample size and longer follow-up are required to validate our findings.",2020,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","['110 PWE, divided into control and exercise groups of 55 each', 'people with epilepsy - Randomized control trial', 'At baseline, mean age of study population was 25.85\u202f±\u202f9.62\u202fyears with 77 (44.5%) women', 'people with epilepsy (PWE']",['home-based exercise program'],"['12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores', 'Average body mass index (BMI', 'physical fitness', 'Distance walked in 6MWT', 'weight and improves physical capacity', 'weight reduction and physical capacity', 'Mean PCS and MCS', 'low-density lipoprotein (LDL-C']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0800908,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","[{'ForeName': '', 'Initials': '', 'LastName': 'SudhindraVooturi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India. Electronic address: sudhindragupta@gmail.com.'}, {'ForeName': 'A N R', 'Initials': 'ANR', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Physiology, Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar, Telangana, India.'}, {'ForeName': 'Sita', 'Initials': 'S', 'LastName': 'Jayalakshmi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107148'] 1743,32522414,"Immunogenicity and safety of two-visit, intradermal pre-exposure rabies prophylaxis simultaneously administrated with chimeric live-attenuated Japanese encephalitis vaccine in children living in rabies and Japanese encephalitis endemic country.","BACKGROUND Reducing the number of doses required for pre-exposure prophylaxis (PrEP) would make it more feasible and cost-effective to implement in children at the highest risk of rabies exposure in Asia. We studied immune response of 2-site intradermal (ID) injection of rabies vaccine on days 0 and 28 for rabies PrEP simultaneously administrated with live-attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) for children living in endemic area. RESEARCH DESIGN AND METHODS Seronegative children (n = 49) aged 12-16 months were randomized 2:1 into two groups: Group A subjects were vaccinated with 0.1-mL ID injection of purified Vero cell rabies vaccine (PVRV), each at two sites on day (D) 0 and D28; Group B subjects were vaccinated with conventional 0.5-mL intramuscular PVRV on D0, D7 and D28. Both groups received one dose of JE-CV subcutaneously on D0 and D365. Rabies virus neutralizing antibody (RVNA) titers were measured on D0, D42 and D365 after vaccination; Japanese Encephalitis (JE) neutralizing antibody titers were determined on D0, D42, D365 and D379. RESULTS All children had RVNA ≥ 0.5 IU/mL on D42 (geometric mean titers [GMTs] of RVNA 14.35 IU/mL [Group A] and 14.83 IU/mL [Group B], p > 0.05]). On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL (p > 0.05), respectively. All children had seroprotection following booster dose of JE-CV. There were no vaccine-related SAEs observed. CONCLUSION The 2-site ID PrEP with PVRV on days 0 and 28 co-administrated with JE-CV are safe and immunogenic.",2020,"On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL","['All children had RVNA\xa0≥', 'children at the highest risk of rabies exposure in Asia', 'Seronegative children (n\xa0=\xa049) aged 12-16\xa0months', 'children living in rabies and Japanese encephalitis endemic country', 'children living in endemic area']","['pre-exposure prophylaxis (PrEP', 'rabies PrEP simultaneously administrated with live-attenuated Japanese encephalitis chimeric virus vaccine (JE-CV', 'two-visit, intradermal pre-exposure rabies prophylaxis simultaneously administrated with chimeric live-attenuated Japanese encephalitis vaccine', '2-site intradermal (ID) injection of rabies vaccine', 'JE-CV subcutaneously on D0 and D365', '0.1-mL ID injection of purified Vero cell rabies vaccine (PVRV', '14.83\xa0IU/mL', 'IU/mL']",['Immunogenicity and safety'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034497', 'cui_str': 'Rabies virus'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0014057', 'cui_str': 'Japanese encephalitis virus disease'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014057', 'cui_str': 'Japanese encephalitis virus disease'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1320204', 'cui_str': 'Rabies prophylaxis'}, {'cui': 'C0771080', 'cui_str': 'Japanese Encephalitis Vaccines'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",49.0,0.0692663,"On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL","[{'ForeName': 'Piyada', 'Initials': 'P', 'LastName': 'Angsuwatcharakon', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand. Electronic address: Terapong.T@chula.ac.th.'}, {'ForeName': 'Natchaya', 'Initials': 'N', 'LastName': 'Ratananpinit', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Sutee', 'Initials': 'S', 'LastName': 'Yoksan', 'Affiliation': 'Center for Vaccine Development, Institute of Molecular Biosciences, Mahidol University, Bangkok 10700, Thailand.'}, {'ForeName': 'Wachiraporn', 'Initials': 'W', 'LastName': 'Saengseesom', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Roongrawee', 'Initials': 'R', 'LastName': 'Sriaksorn', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Nattasri', 'Initials': 'N', 'LastName': 'Raksahket', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Terapong', 'Initials': 'T', 'LastName': 'Tantawichien', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand; Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkon University, Bangkok 10330, Thailand. Electronic address: terapong_tantawichien@hotmail.com.'}]",Vaccine,['10.1016/j.vaccine.2020.05.054'] 1744,32522503,"Sensory aspects of acceptability of bitter-flavoured 7.5 mm film-coated tablets in adults, preschool and school children.","There is great interest in demonstrating acceptability of solid oral formulations in paediatric populations. This study investigated the acceptability of small, 7.5 mm, bitter-flavoured, coated tablets in healthy children and adults. A randomised, double-blind acceptability test was performed involving 101 children (4-12 years) and 52 adults (18-75 years). Acceptability was measured by participants as sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions. Additionally, the taste-masking effect of film coatings was assessed based on the intensity of bitterness perception. At least one tablet was voluntarily swallowed by 35.7% of 4-6-year olds, 74% of 7-12-year olds and 98% of adults. The bitterness of the tablet did not affect participants' ability to swallow it. The sensory properties determined whether the tablet was acceptable. The following factors: low bitterness, high smoothness, high slipperiness and pleasant aftertaste had a positive impact on overall palatability in both populations. The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability. This study demonstrates the multifactorial nature of palatability of tablets and highlights that adults' palatability evaluation cannot be directly translated to a paediatric population.",2020,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","['healthy children and adults', 'adults, preschool and school children', '101 children (4-12 years) and 52 adults (18-75 years']",['bitter-flavoured 7.5 mm film-coated tablets'],"['overall palatability', 'Acceptability', 'sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",101.0,0.21376,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","[{'ForeName': 'Justyna Katarzyna', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: h.k.batchelor@bham.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119511'] 1745,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757'] 1746,32522811,Interventions supporting long term adherence and decreasing cardiovascular events after myocardial infarction (ISLAND): pragmatic randomised controlled trial.,"OBJECTIVE To test a scalable health system intervention to improve long term adherence to secondary prevention treatments among patients who have had a recent myocardial infarction. DESIGN Three arm, pragmatic randomised controlled trial with blinded outcome assessment. SETTING Nine cardiac centres in Ontario, Canada. PARTICIPANTS 2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry. INTERVENTIONS Participants were randomised 1:1:1 to receive usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls. The phone calls were delivered first by an interactive automated system to screen for non-adherence to treatment. Trained lay health workers followed up as necessary. Interventions were coordinated centrally but delivered from each patient's hospital site. MAIN OUTCOME MEASURES Co-primary outcomes were completion of cardiac rehabilitation and adherence to recommended medication. Data were collected by blinded assessors through patient report and from administrative health databases at 12 months. RESULTS 2632 patients (mean age 66, 71% male) were randomised: 878 to the full intervention (mail plus phone calls), 878 to mail only, and 876 to usual care. Of the respondents, 174 (27%) of 643 in the usual care group, 200 (32%) of 628 in the mail only group, and 196 (37%) of 531 allocated to the full intervention completed cardiac rehabilitation (adjusted odds ratio 1.55, 95% confidence interval 1.18 to 2.03). In the mail plus phone group, 11.7%, 6.0%, 14.4%, 32.9%, and 35.0% reported adherence to 0, 1, 2, 3, and 4 drug classes after one year, respectively, in comparison with 12.5%, 6.8%, 13.6%, 30.2%, and 36.8% in the mail only group, and 12.2%, 8.4%, 13.1%, 30.3%, and 36.1% in the usual care group, respectively (mail only v usual care, odds ratio 0.98, 95% confidence interval 0.81 to 1.19; full intervention v usual care, 0.99, 0.82 to 1.20). CONCLUSIONS Scalable interventions delivered by mail plus phone can increase completion of cardiac rehabilitation after myocardial infarction but not adherence to medication. More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication. TRIAL REGISTRATION ClinicalTrials.gov NCT02382731, registered 9 March 2015 before any patient enrolment.",2020,"More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication. ","['2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry', 'Nine cardiac centres in Ontario, Canada', '2632 patients (mean age 66, 71% male) were randomised: 878 to the', 'patients who have had a recent myocardial infarction']","['full intervention (mail plus phone calls', 'usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls']","['cardiovascular events', 'cardiac rehabilitation', 'completion of cardiac rehabilitation and adherence to recommended medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",2632.0,0.141035,"More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication. ","[{'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Department of Family and Community Medicine, Women's College Hospital, 76 Grenville Street, Toronto, ON, M5S1B2, Canada noah.ivers@utoronto.ca.""}, {'ForeName': 'Jon-David', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bouck', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCready', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': 'Faculty of Health, York University, Toronto, ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cunningham', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bosiak', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Suskin', 'Affiliation': ""Cardiac Rehabilitation and Secondary Prevention Programme of St Joseph's Health Care London, ON, Canada.""}, {'ForeName': 'Harindra C', 'Initials': 'HC', 'LastName': 'Wijeysundera', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Atzema', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Natarajan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1731'] 1747,32525416,"Effect of Hypertonic Saline during Flexible Nasopharyngeal Laryngoscopy: A Double-Blinded, Randomized, Controlled Trial.","Objectives: Flexible nasopharyngeal laryngoscopy (NPL) is a cost-effective, simple procedure that provides visualization of the nasal airways. However, it involves a number of challenges for both the clinician and the patient. Hypertonic saline nasal wash is used to prevent nasal secretion in acute/chronic sinusitis and after nasal surgery. We aimed to determine the efficacy of hypertonic saline by comparing the clinician's and patients' experiences during NPL. Methods: This prospective, double-blinded, randomized, controlled study was performed at a tertiary referral university hospital. Two hundred patients were randomly divided into hypertonic saline, lidocaine, xylometazoline, and isotonic saline groups. During NPL, the clinician's experiences in terms of the quality of the field of view and the patients' experiences in terms of pain and discomfort resulting from the 4 premedication drugs were compared. Results: The groups differed significantly in terms of the clinician's field of view, and patients' pain scores and levels of discomfort ( P  < 0.025). The field of view results were the highest in the hypertonic saline group, and the lowest in the lidocaine group. The pain scores were the lowest in the lidocaine group, whereas they were the highest in the hypertonic saline group. The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups. Conclusion: The use of hypertonic saline facilitated the NPL procedure by improving the clinician's field of view. Moreover, intranasal hypertonic saline reduced the patient's discomfort. Intranasal hypertonic saline can be a good alternative to premedication before NPL.",2020,"The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups.","['tertiary referral university hospital', 'acute/chronic sinusitis and after nasal surgery', 'Two hundred patients', 'Flexible Nasopharyngeal Laryngoscopy']","['hypertonic saline, lidocaine, xylometazoline, and isotonic saline', 'intranasal hypertonic saline', 'lidocaine', 'xylometazoline', 'Intranasal hypertonic saline', 'Flexible nasopharyngeal laryngoscopy (NPL', 'Hypertonic Saline', 'Hypertonic saline nasal', 'hypertonic saline']","[""clinician's field of view, and patients' pain scores and levels of discomfort"", 'pain scores', 'discomfort scores', ""patient's discomfort"", 'pain and discomfort', 'nasal secretion']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0078643', 'cui_str': 'xylometazoline'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",200.0,0.0720424,"The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups.","[{'ForeName': 'Merih', 'Initials': 'M', 'LastName': 'Onal', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Keles', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Erdur', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Necat', 'Initials': 'N', 'LastName': 'Alatas', 'Affiliation': 'Department of Otorhinolaryngology, Konya Educational and Training Hospital, Konya, Turkey.'}, {'ForeName': 'Ozkan', 'Initials': 'O', 'LastName': 'Onal', 'Affiliation': 'Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1777490'] 1748,32525474,Thoracoscopy and talc poudrage compared with intercostal drainage and talc slurry infusion to manage malignant pleural effusion: the TAPPS RCT.,"BACKGROUND There are around 40,000 new cases of malignant pleural effusion in the UK each year. Insertion of talc slurry via a chest tube is the current standard treatment in the UK. However, some centres prefer local anaesthetic thoracoscopy and talc poudrage. There is no consensus as to which approach is most effective. OBJECTIVE This trial tested the hypothesis that thoracoscopy and talc poudrage increases the proportion of patients with successful pleurodesis at 3 months post procedure, compared with chest drain insertion and talc slurry. DESIGN This was a multicentre, open-label, randomised controlled trial with embedded economic evaluation. Follow-up took place at 1, 3 and 6 months. SETTING This trial was set in 17 NHS hospitals in the UK. PARTICIPANTS A total of 330 adults with a confirmed diagnosis of malignant pleural effusion needing pleurodesis and fit to undergo thoracoscopy under local anaesthetic were included. Those adults needing a tissue diagnosis or with evidence of lung entrapment were excluded. INTERVENTIONS Allocation took place following minimisation with a random component, performed by a web-based, centralised computer system. Participants in the control arm were treated with a bedside chest drain insertion and 4 g of talc slurry. In the intervention arm, participants underwent local anaesthetic thoracoscopy with 4 g of talc poudrage. MAIN OUTCOME MEASURES The primary outcome measure was pleurodesis failure at 90 days post randomisation. Secondary outcome measures included mortality and patient-reported symptoms. A cost-utility analysis was also performed. RESULTS A total of 166 and 164 patients were allocated to poudrage and slurry, respectively. Participants were well matched at baseline. For the primary outcome, no significant difference in pleurodesis failure was observed between the treatment groups at 90 days, with rates of 36 out of 161 (22%) and 38 out of 159 (24%) noted in the poudrage and slurry groups, respectively (odds ratio 0.91, 95% confidence interval 0.54 to 1.55; p  = 0.74). No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p  = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p  = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p  = 0.70]. At £20,000 per quality-adjusted life-year gained, poudrage would have a 0.36 probability of being cost-effective compared with slurry. LIMITATIONS Entry criteria specified that patients must be sufficiently fit to undergo thoracoscopy, which may make the results less applicable to those patients presenting with a greater degree of frailty. Furthermore, the trial was conducted on an open-label basis, which may have influenced the results of patient-reported measures. CONCLUSIONS The TAPPS (evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry) trial has robustly demonstrated that there is no additional clinical effectiveness or cost-effectiveness benefit in performing talc poudrage at thoracoscopy over bedside chest drain and talc slurry for the management of malignant pleural effusion. TRIAL REGISTRATION Current Controlled Trials ISRCTN47845793. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 26. See the NIHR Journals Library website for further project information.",2020,"No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p  = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p  = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p  = 0.70].","['A total of 166 and 164 patients', '17 NHS hospitals in the UK', 'A total of 330 adults with a confirmed diagnosis of malignant pleural effusion needing pleurodesis and fit to undergo thoracoscopy under local anaesthetic were included', 'adults needing a tissue diagnosis or with evidence of lung entrapment were excluded']","['intercostal drainage and talc slurry infusion', 'thoracoscopy and talc poudrage', 'bedside chest drain insertion and 4\u2009g of talc slurry', 'TAPPS', 'local anaesthetic thoracoscopy with 4\u2009g of talc poudrage', 'Thoracoscopy and talc poudrage']","['proportion of patients with successful pleurodesis', 'mortality and patient-reported symptoms', 'cause mortality', 'adverse events', 'mean number of nights in hospital', 'pleurodesis failure']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1285497', 'cui_str': 'Entrapment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",330.0,0.337884,"No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p  = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p  = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p  = 0.70].","[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhatnagar', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24260'] 1749,32526490,Creativity on tap 2: Investigating dose effects of alcohol on cognitive control and creative cognition.,"This preregistered study aimed to replicate and extend research on the role of cognitive control in creative cognition by examining dose effects of alcohol in a randomized controlled trial. A sample of 125 participants was randomly assigned to three experimental groups, either drinking alcoholic beer (BAC = 0.03 or 0.06) or drinking non-alcoholic beer (placebo-control group). Before and after the alcohol intervention, participants completed two tests of cognitive control and two established creative thinking tasks. A BAC of 0.06 led to an impairment of verbal fluency, while working memory performance was unaffected at both alcohol levels. Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity. These results indicate that moderate alcohol levels have dose-dependent, selective effects on cognitive control, and that minor impairments of cognitive control do not generally increase or attenuate creative thinking performance.",2020,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.",['A sample of 125 participants'],"['drinking alcoholic beer (BAC\xa0=\xa00.03 or 0.06) or drinking non-alcoholic beer (placebo-control group', 'alcohol', 'cognitive control and two established creative thinking tasks']","['creative thinking performance', 'verbal fluency, while working memory performance', 'RAT performance, divergent thinking fluency or divergent thinking creativity', 'cognitive control and creative cognition']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",125.0,0.0319793,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: mathias.benedek@uni-graz.at.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Zöhrer', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102972'] 1750,32526502,The effect of rumination and distraction on auditory hallucinatory experiences: An analogue experimental study.,"BACKGROUND AND OBJECTIVES The cognitive model of voices suggests that negative appraisals of hallucinatory experiences result in responses, such as rumination, which maintain voice-hearing. Our principal aim was to investigate the effect of rumination on the frequency of voice-hearing. METHODS A two-group randomised experimental design was employed using a non-clinical sample. A total of 106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm. False feedback designed to cause a negative interpretation of auditory intrusions was provided and participants were randomly allocated to either a distraction or rumination condition. Participants performed the auditory task for a second time, and the total number of false alarms and distress scores were compared between groups. RESULTS A Mann-Whitney U test revealed that the manipulation of rumination was successful (p = 0.007). We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. LIMITATIONS Findings largely relate to a female undergraduate psychology sample. CONCLUSION Results of this non-clinical study do not support the hypothesis that rumination leads to an increase in the frequency of voice-hearing on a laboratory task.",2020,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. ","['106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm', 'auditory hallucinatory experiences', 'female undergraduate psychology sample']","['distraction or rumination condition', 'rumination and distraction']","['distress', 'auditory task', 'total number of false alarms and distress scores', 'frequency of voice-hearing']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",106.0,0.0413272,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. ","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Pennine Care NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: sandra.bucci@manchester.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101592'] 1751,32526534,Trial design of the RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs health system plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. METHODS RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. DISCUSSION This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. TRIAL REGISTRATION Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001'] 1752,32526606,Choosing vaginal birth after caesarean section: Motivating factors.,"OBJECTIVES to examine the factors that motivate women who have had a previous caesarean section to consider planning a vaginal birth. DESIGN a qualitative descriptive study with thematic analysis, drawing on interviews with women participating in a two arm, un-blinded randomised controlled trial (RCT) of midwifery continuity of care for increasing the proportion of women planning VBAC. SETTING A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia. PARTICIPANTS a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth. FINDINGS These women were committed to natural birth and drew on their previous experience of caesarean section to highlight the downside of recovery post caesarean section. Decision making for these women was complex. During the decision-making process, women individualised the information provided to balance risk and chance within the context of their own circumstance. Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. CONCLUSIONS Recovery post caesarean section is an important consideration that is under emphasised in the informed consent process. There is opportunity for midwives to contribute proactively in promoting vaginal birth for women who have experienced a previous caesarean section. IMPLICATIONS FOR PRACTICE women should be assisted to make informed choices with balanced information that includes recovery from surgical birth. Models of care that include a significant role for midwives and strategies that proactively encourage vaginal birth for women after previous caesarean section are needed.",2020,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. ","['A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia', 'a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth', 'motivate women who have had a previous caesarean section to consider planning a vaginal birth', 'women who have experienced a previous caesarean section']",[],[],"[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",[],[],18.0,0.0830958,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. ","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'University of Canberra and ACT Government Health Directorate, Faculty of Health, Bruce, 2617, ACT, Australia. Electronic address: Deborah.davis@canberra.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'S Homer', 'Affiliation': 'Maternal and Child Health Program, Burnet Institute, Melbourne, Australia; Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Clack', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Sabera', 'Initials': 'S', 'LastName': 'Turkmani', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Maralyn', 'Initials': 'M', 'LastName': 'Foureur', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia; Hunter New England Local Health District & University of Newcastle, NSW, Australia.'}]",Midwifery,['10.1016/j.midw.2020.102766'] 1753,32526916,Immediate Effects of Tibialis Anterior and Calf Muscle Taping on Center of Pressure Excursion in Chronic Stroke Patients: A Cross-Over Study.,"Stroke patients often have muscles spasticity, difficulty with posture control, and tend to fall. This study investigated the use of kinesiology tape for patients with spasticity of ankle muscles after stroke. This study had a randomized, repeated measures design, and evaluated the immediate effect of kinesiology tape on the center of pressure (COP) excursion when applied to the calf and tibialis anterior muscles in stroke survivors. We determined that the taping attachment direction affects the COP movement. Twenty subjects were randomly assigned to the tibialis anterior taping condition, calf taping condition, or nontaping condition. Condition excursion was assessed. The measured variables included the paretic side area, nonparetic side area, forward area, and backward area of COP. All evaluations were conducted immediately after taping. COP excursion for chronic stroke survivors improved after tibialis anterior and calf taping (p < 0.05). Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05). Kinesiology tape immediately increased the forward and backward COP excursion for patients with stroke.",2020,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","['Twenty subjects', 'patients with spasticity of ankle muscles after stroke', 'Chronic Stroke Patients', 'stroke survivors', 'patients with stroke']","['tibialis anterior taping condition, calf taping condition, or nontaping condition', 'Tibialis Anterior and Calf Muscle Taping', 'kinesiology tape']","['center of pressure (COP) excursion', 'COP excursion for chronic stroke survivors', 'forward and backward COP excursion', 'tibialis anterior taping conditions', 'Calf taping conditions', 'paretic side area, nonparetic side area, forward area, and backward area of COP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",20.0,0.0161572,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27600, Korea.'}, {'ForeName': 'Tae-Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'NEULBOM Hospital 17, Poeun-daero 59 beon-gil, Suji-gu, Yongin-si, Gyeonggi-do 16864, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam 330-714, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114109'] 1754,31922456,Evaluating approaches to marketing cognitive behavioral therapy: does evidence matter to consumers?,"Direct-to-consumer marketing initiatives may improve utilization of evidence-based therapy.  An important decision in such marketing efforts is how to effectively present scientific evidence supporting these treatments to potential consumers (if at all). This OSF preregistered study experimentally tested whether the language used to describe research evidence supporting cognitive behavioral therapy (CBT) for anxiety disorders affected consumer treatment attitudes and intentions. Adult participants (N = 303) recruited via mTurk were first assessed for their understanding of the term ""evidence-based."" They were then randomized to read a description of CBT employing either: formal research language (e.g., ""large-scale clinical trials have demonstrated…""), informal language about research support derived from prior qualitative work (e.g., ""people have better results…""), or no information about research. Perceptions of CBT (including credibility and expectancy) and likelihood of pursuing CBT (pull demand) were assessed. Results indicated that only half the sample understood the meaning of the term ""evidence-based."" The conditions that discussed research support outperformed the control condition on CBT perceptions, credibility, general expectancies, and perceived effectiveness. Post-hoc comparisons provided some evidence that qualitatively-derived language was more effective than formal research language for promoting positive perceptions of CBT. Implications for marketing content are discussed.",2020,Post-hoc comparisons provided some evidence that qualitatively-derived language was more effective than formal research language for promoting positive perceptions of CBT.,"['Adult participants (N = 303) recruited via mTurk were first assessed for their understanding of the term ""evidence-based']","['cognitive behavioral therapy (CBT', 'marketing cognitive behavioral therapy']","['Perceptions of CBT (including credibility and expectancy) and likelihood of pursuing CBT (pull demand', 'CBT perceptions, credibility, general expectancies, and perceived effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0451564,Post-hoc comparisons provided some evidence that qualitatively-derived language was more effective than formal research language for promoting positive perceptions of CBT.,"[{'ForeName': 'Casey A', 'Initials': 'CA', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychology, Skidmore College , Saratoga Springs, NY, USA.'}, {'ForeName': 'Gabriella T', 'Initials': 'GT', 'LastName': 'Ponzini', 'Affiliation': 'Department of Psychology, West Virginia University , Morgantown, WV, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University School of Public Health , Providence, RI, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2019.1682654'] 1755,32501596,Effects of a person-centred approach in a school setting for adolescents with chronic pain-The HOPE randomized controlled trial.,"BACKGROUND Chronic pain among adolescents is common but effective interventions applicable in a school setting are rare. Person-centred care (PCC) is a key factor in improving health by engaging persons as partners in their own care. METHODS In this randomized controlled trial, a total of 98 adolescents in secondary school or upper secondary school (aged 14 - 21 years) with chronic pain were randomly assigned to a PCC intervention or standard school healthcare. In the intervention group a pain management programme, based on a PCC approach, comprising four face-to-face sessions with a school nurse over a period of 5 weeks was added to standard school healthcare. The main outcome measure was self-efficacy in daily activities (SEDA scale) and rating scales for pain intensity and pain impact were used as secondary outcome measures. RESULTS At the follow-up, no significant differences were found between the groups in the SEDA scale (p = .608) or in the rating scales for pain intensity (p = .261) and pain impact (p = .836). In the sub-group analysis, a significant improvement in the SEDA scale was detected at the secondary school in favour of the PCC intervention group (p = .021). CONCLUSION In this pain management programme based on a PCC approach, we found no effect in the total sample, but the programme showed promising results to improve self-efficacy in daily activities among adolescents at secondary school. SIGNIFICANCE This study evaluates the effects of a pain management programme based on a PCC approach in a school setting addressing adolescents at upper secondary and secondary schools with chronic pain. No overall effects were shown, but results illustrate that the intervention improved self-efficacy in adolescents at secondary school. Implementation of a PCC approach in a school setting may have the potential to improve self-efficacy in daily activities for adolescents with chronic pain at secondary school.",2020,"At the follow-up, no significant differences were found between the groups in the SEDA scale (p=0.608) or in the rating scales for pain intensity (p=0.261) and pain impact (0.836).","['98 adolescents in secondary school or upper secondary school (aged 14-21 years) with chronic pain', 'adolescents at secondary school', 'adolescents with chronic pain ']","['Person-centred care (PCC', 'person-centred approach', 'PCC intervention or standard school health care']","['pain impact', 'rating scales for pain intensity', 'self-efficacy', 'self-efficacy in daily activities (SEDA scale) and rating scales for pain intensity and pain impact', 'SEDA scale']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",98.0,0.102401,"At the follow-up, no significant differences were found between the groups in the SEDA scale (p=0.608) or in the rating scales for pain intensity (p=0.261) and pain impact (0.836).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wallbing', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gösta', 'Initials': 'G', 'LastName': 'Alfvén', 'Affiliation': 'Clintec, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Kemani', 'Affiliation': 'Department of Clinical Neuroscience (CNS), Stockholm, Sweden.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Lundberg', 'Affiliation': 'Centre for Person-Centred Care (GPCC), University of Gothenburg, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Wigert', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]","European journal of pain (London, England)",['10.1002/ejp.1614'] 1756,32502050,Effect of video-guided educational intervention on school engagement of adolescent students with hearing impairment: Implications for health and physical education.,"BACKGROUND/OBJECTIVE Hearing impaired students still face stigmatization and marginalization especially in inclusive classrooms in developing regions. This negatively impacts their school engagement. The present study aimed at ascertaining the effect of video-guided educational intervention on school engagement of hearing impaired students. METHOD Randomized controlled trial design was adopted for the present study. A total of 46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study. The students were randomly assigned to groups - intervention group and care-as-usual control group. A video-guided educational intervention package which consists of 13-minutes captioned video clips with school engagement themes served as the treatment intervention. Data were collected at 3 different times (pre-test, post-test and follow up) using School Engagement Scale created by Fredericks, Blumenfeld, Friedel and Paris (2005). Data were analyzed using independent sample t-test, paired sample t-test, Cohen d and Chi-square. RESULTS Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = -9.305, P < .001; Emotional: t(24) = -7.772, P < .001; Cognitive: t(24) = -7.330 P < .001) as well as total student engagement (t(24) = 12.022, P < .001, Δ = 5.362). Also, the students who took part in the video-guided educational intervention maintained improved school engagement at follow-up. CONCLUSION Video-guided educational intervention is an effective intervention for improving school engagement of hearing impaired adolescent students. Since acquiring relevant education is essential for leading a quality life especially among the special needs population, it was recommended that students with hearing impairment should be helped to acquire life skills through education by fostering their school engagement.",2020,"RESULTS Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","['students with hearing impairment', 'hearing impaired adolescent students', '46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study', 'school engagement of hearing impaired students', 'adolescent students with hearing impairment']","[' intervention group and care-as-usual control group', 'video-guided educational intervention', 'Video-guided educational intervention']","['total student engagement', 'school engagement level', 'school engagement']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0308663,"RESULTS Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","[{'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Theresa Onyema', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Ngozi O', 'Initials': 'NO', 'LastName': 'Obiyo', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Christian Iheanacho', 'Initials': 'CI', 'LastName': 'Agboti', 'Affiliation': 'Department of Sociology/Criminology and Security Studies, Alex-Ekwueme Federal University Ndufu Alike Ikwo, Ebonyi State, Nigeria.'}, {'ForeName': 'Chinedozie', 'Initials': 'C', 'LastName': 'Uwakwe', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Benedict C', 'Initials': 'BC', 'LastName': 'Eze', 'Affiliation': 'Department of Arts Education.'}]",Medicine,['10.1097/MD.0000000000020643'] 1757,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002'] 1758,32502908,Effects of 1 mA and 2 mA transcranial direct current stimulation on working memory performance in healthy participants.,"Anodal transcranial current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) has been shown to enhance working memory (WM) in neuropsychiatric patients. In healthy populations, however, tDCS obtains inconclusive results, mostly due to heterogeneous study and stimulation protocols. Here, we approached these issues by investigating effects of tDCS intensity on simultaneous WM performance with three cognitive loads by directly comparing findings of two double-blind, cross-over, sham-controlled experiments. TDCS was administrated to the left DLPFC at intensity of 1 mA (Experiment 1) or 2 mA (Experiment 2), while participants completed a verbal n-back paradigm (1-, 2-, 3-back). Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load. The present study suggests that cognitive load rather than tDCS intensity could be a decisive factor for effects on WM. Moreover, it emphasizes the need of thorough investigation on study parameters to develop more efficient stimulation protocols.",2020,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","['healthy participants', 'neuropsychiatric patients']","['1\xa0mA and 2\xa0mA transcranial direct current stimulation', 'TDCS', 'Anodal transcranial current stimulation (tDCS']",['working memory performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0450811,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany. Electronic address: Irina.papazova@med.uni-muenchen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Henning', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schwippel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, BKH Augsburg, Medical Faculty, University of Augsburg, Germany.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102959'] 1759,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer. METHODS Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity. RESULTS 763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. CONCLUSION This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. ","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027'] 1760,32509702,A temporary forward head posture decreases function of cervical proprioception.,"Increased use of smartphones can cause abnormal alignment of head and neck, resulting in forward head posture (FHP). This can lead to change in the structures and function of the cervical vertebrae. The purpose of this study was to determine the impact on deep neck flexor muscles, proprioception, vestibular function, and balance of subjects with induced FHP by using smartphone. Twenty-two healthy persons were randomly divided into two groups. The FHP group maintained a craniovertebral angle (CVA) of <49° and a normal head posture group maintained a CVA of >50° watching the smartphone for 40 min. We measured the area of the longus colli and longus capitis muscles, cervical joint position sense, Romberg test, subjective visual vertical test, and subjective visual horizontal test. There was no significant difference in the deep neck flexor muscles, vestibular function, and static balance between the groups. However, there was a significant difference in the cervical proprioception ( P <0.05). Proprioception may be considered to be the most influential factor in induced FHP by smartphone viewing.",2020,"There was no significant difference in the deep neck flexor muscles, vestibular function, and static balance between the groups.","['subjects with induced FHP by using smartphone', 'Twenty-two healthy persons']","['normal head posture group maintained a CVA of >50° watching the smartphone', 'FHP']","['deep neck flexor muscles, vestibular function, and static balance', 'cervical proprioception', 'deep neck flexor muscles, proprioception, vestibular function, and balance', 'area of the longus colli and longus capitis muscles, cervical joint position sense, Romberg test, subjective visual vertical test, and subjective visual horizontal test']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0439780', 'cui_str': 'Forward'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0224169', 'cui_str': 'Longus colli muscle structure'}, {'cui': 'C0224107', 'cui_str': 'Structure of longus capitis muscle'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0278127', 'cui_str': 'Romberg sign'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",22.0,0.0156369,"There was no significant difference in the deep neck flexor muscles, vestibular function, and static balance between the groups.","[{'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Ha', 'Affiliation': 'Department of Physical Therapy, Graduate School, Kyungnam University, Changwon, Korea.'}, {'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Sung', 'Affiliation': 'Department of Physical Therapy, Graduate School, Kyungnam University, Changwon, Korea.'}]",Journal of exercise rehabilitation,['10.12965/jer.2040106.053'] 1761,32510130,Kisspeptin and neurokinin B interactions in modulating gonadotropin secretion in women with polycystic ovary syndrome.,"STUDY QUESTION What is the role of the hypothalamic neuropeptide neurokinin B (NKB) and its interaction with kisspeptin on GnRH/LH secretion in women with polycystic ovary syndrome (PCOS)? SUMMARY ANSWER Administration of neurokinin 3 receptor antagonist (NK3Ra) for 7 days reduced LH and FSH secretion and LH pulse frequency in women with PCOS, whilst the stimulatory LH response to kisspeptin-10 was maintained. WHAT IS KNOWN ALREADY PCOS is characterized by abnormal GnRH/LH secretion. NKB and kisspeptin are master regulators of GnRH/LH secretion, but their role in PCOS is unclear. STUDY DESIGN, SIZE, DURATION The NK3Ra MLE4901, 40 mg orally twice a day, was administered to women with PCOS for 7 days (n = 8) (vs no treatment, n = 7). On the last day of NK3Ra administration or the equivalent day in those not treated, women were randomized to 7-h kisspeptin-10 (4 µg/kg/h i.v.) or vehicle infusion. This was repeated with the alternate infusion in a subsequent cycle. PARTICIPANTS/MATERIALS, SETTING, METHODS Subjects were women with PCOS, studied in a Clinical Research Facility. Reproductive hormones were measured before and after NK3Ra administration. On the last day of NK3Ra administration (or the equivalent cycle day in untreated women), all women attended for an 8-h frequent blood sampling to allow analysis of the pulsatile LH secretion. MAIN RESULTS AND THE ROLE OF CHANCE NK3Ra reduced LH secretion (4.0 ± 0.4 vs 6.5 ± 0.8 IU/l, P < 0.05) and pulse frequency (0.5 ± 0.1 vs 0.8 ± 0.1 pulses/h, P < 0.05); FSH secretion was also reduced (2.0 ± 0.3 vs 2.5 ± 0.4 IU/l, P < 0.05). Without NK3Ra pre-treatment, kisspeptin-10 increased LH secretion (5.2 ± 0.5 to 7.8 ± 1.0 IU/L, P < 0.05), with a positive relationship to oestradiol concentrations (r2 = 0.59, P < 0.05). After NK3Ra administration, the LH response to kisspeptin-10 was preserved (vehicle 3.5 ± 0.3 vs 9.0 ± 2.2 IU/l with kisspeptin-10, P < 0.05), but the positive correlation with oestradiol concentrations was abolished (r2 = 0.07, ns. after NK3Ra). FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. LIMITATIONS, REASONS FOR CAUTION The study did not explore the dose relationship of the effect of NK3R antagonism. The impact of obesity or other aspects of the variability of the PCOS phenotype was not studied due to the small number of subjects. WIDER IMPLICATIONS OF THE FINDINGS These data demonstrate the interactive regulation of GnRH/LH secretion by NKB and kisspeptin in PCOS, and that the NKB system mediates aspects of oestrogenic feedback. STUDY FUNDING/COMPETING INTEREST(S) Wellcome Trust through Scottish Translational Medicine and Therapeutics Initiative (102419/Z/13/A) and MRC grants (G0701682 to R.P.M. and R.A.A.) and MR/N022556/1 to the MRC Centre for Reproductive Health. This work was performed within the Edinburgh Clinical Research Facility. J.T.G. has undertaken consultancy work for AstraZeneca and Takeda Pharmaceuticals and is an employee of Boehringer Ingelheim. R.P.M. has consulted for Ogeda and was CEO of Peptocrine. R.A.A. has undertaken consultancy work for Merck, Ferring, NeRRe Therapeutics and Sojournix Inc. J.D.V. and K.S. have nothing to disclose. TRIAL REGISTRATION NUMBER N/A.",2020,"FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. ","['women with polycystic ovary syndrome (PCOS', 'Subjects were women with PCOS, studied in a Clinical Research Facility', 'women with PCOS', 'women with polycystic ovary syndrome']","['hypothalamic neuropeptide neurokinin B (NKB', 'Kisspeptin and neurokinin B interactions', 'NK3Ra', 'NK3Ra MLE4901', 'kisspeptin']","['pulse frequency', 'LH response to kisspeptin-10', 'NK3Ra reduced LH secretion', 'FSH secretion', 'LH and FSH secretion and LH pulse frequency', 'oestradiol concentrations', 'Reproductive hormones', 'positive correlation with oestradiol concentrations', 'LH secretion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0027847', 'cui_str': 'Neurokinin beta'}, {'cui': 'C0540309', 'cui_str': 'KISS1 protein, human'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1721258', 'cui_str': 'kisspeptin-10 protein, human'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.109421,"FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. ","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skorupskaite', 'Affiliation': ""MRC Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.""}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Warwick Medical School, Coventry CV4 7AL, UK.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Center for Translational Science Activities, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Millar', 'Affiliation': 'Centre for Neuroendocrinology and Mammal Research Institute, University of Pretoria, 0028 Pretoria, South Africa.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': ""MRC Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa104'] 1762,32512124,Placebo-induced pain reduction is associated with negative coupling between brain networks at rest.,"Placebos can reduce pain by inducing beliefs in the effectiveness of an actually inert treatment. Such top-down effects on pain typically engage lateral and medial prefrontal regions, the insula, somatosensory cortex, as well as the thalamus and brainstem during pain anticipation or perception. Considering the level of large-scale brain networks, these regions spatially align with fronto-parietal/executive control, salience, and sensory-motor networks, but it is unclear if and how placebos alter interactions between them during rest. Here, we investigated how placebo analgesia affected intrinsic network coupling. Ninety-nine human participants were randomly assigned to a placebo or control group and underwent resting-state fMRI after pain processing. Results revealed inverse coupling between two resting-state networks in placebo but not control participants. Specifically, networks comprised the bilateral somatosensory cortex and posterior insula, as well as the brainstem, thalamus, striatal regions, dorsal and rostral anterior cingulate cortex, and the anterior insula, respectively. Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group. Altogether, these findings provide initial evidence that placebo analgesia affects the intrinsic communication between large-scale brain networks, even in the absence of pain. We suggest a theoretical model where placebo analgesia might affect processing within a descending pain-modulatory network, potentially segregating it from somatosensory regions that may code for painful experiences.",2020,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.",['Ninety-nine human participants'],"['Placebos', 'Placebo', 'placebo or control group and underwent resting-state fMRI after pain processing', 'placebo']","['individual pain intensity', 'pain reduction', 'medication effectiveness', 'pain']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0423732', 'cui_str': 'After pains'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",99.0,0.206348,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Wagner', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria. Electronic address: isabella.wagner@univie.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117024'] 1763,32512127,"Creating while taking turns, the choice to unlocking group creative potential.","This study aimed to examine how communication modes affect creative idea generation in groups. Three communication mode conditions were created: natural (N), turn-taking (T), and electronic brainstorming (E). Participants were randomly recruited and grouped in dyads to solve one alternative uses task (AUT) in each condition, during which functional near-infrared spectroscopy (fNIRS)-based hyperscanning was used to record interpersonal neural responses. No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition. In addition, AUT uniqueness, AUT fluency, and perspective-taking behaviours increased faster in the T condition than in the other conditions. The T condition also showed higher perspective-taking behaviours than did the other conditions. Moreover, fNIRS data showed higher interpersonal brain synchronisation (IBS) increments at the right angular gyrus in the T condition than in the other conditions, which positively predicted perspective-taking behaviours between individuals during group creativity tasks. These findings indicate that when group members create together while taking turns, both creative performance and interpersonal interaction processes can be stimulated.",2020,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.",[],[],"['AUT fluency, and perspective-taking behaviours', 'perspective-taking behaviours', 'interpersonal brain synchronisation (IBS', 'AUT fluency']",[],[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.0212556,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117025'] 1764,32512690,Attentiveness and Fidgeting While Using a Stand-Biased Desk in Elementary School Children.,"Standing desks are a viable option to decrease sedentary time in the classroom. However, it is important that standing desks are not detrimental to classroom behavior or learning. The purpose of this study was to evaluate the impact of stand-biased desks on fidgeting and attentiveness. Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study. The intervention employed a within-classroom crossover design, with teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks. Direct observation of student's attentive and fidgeting behaviors occurred at three assessment periods, at baseline when all students were in a sitting desk condition and at the end of each nine-week intervention. Stand-biased desks did not influence fidgeting behavior, but did have an impact on attentive behavior. Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention. While fidgeting and non-attentive episodes ( p = 0.034) were significantly related, the type of desk did not significantly moderate this relationship ( p = 0.810). Standing desks can be incorporated into the classroom without negatively influencing classroom behavior.",2020,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"['Elementary School Children', 'Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study']",['teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks'],"['Attentiveness and Fidgeting', 'sedentary time']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C0424235', 'cui_str': 'Fidgeting'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.0251875,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Swartz', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Tokarek', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Krista M', 'Initials': 'KM', 'LastName': 'Lisdahl', 'Affiliation': 'Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Chi C', 'Initials': 'CC', 'LastName': 'Cho', 'Affiliation': 'Center for Aging and Translational Research, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113976'] 1765,32513936,Investigating resting brain perfusion abnormalities and disease target-engagement by intranasal oxytocin in women with bulimia nervosa and binge-eating disorder and healthy controls.,"Advances in the treatment of bulimia nervosa and binge-eating disorder (BN/BED) have been marred by our limited understanding of the underpinning neurobiology. Here we measured regional cerebral blood flow (rCBF) to map resting perfusion abnormalities in women with BN/BED compared with healthy controls and investigate whether intranasal oxytocin (OT), proposed as a potential treatment, can restore perfusion in disorder-related brain circuits. Twenty-four women with BN/BED and 23 healthy women participated in a randomized, double-blind, crossover, placebo-controlled study. We used arterial spin labelling MRI to measure rCBF and the effects of an acute dose of intranasal OT (40 IU) or placebo over 18-26 min post dosing, as we have previously shown robust OT-induced changes in resting rCBF in men in a similar time-window (15-36 min post dosing). We tested for effects of treatment, diagnosis and their interaction on extracted rCBF values in anatomical regions-of-interest previously implicated in BN/BED by other neuroimaging modalities, and conducted exploratory whole-brain analyses to investigate previously unidentified brain regions. We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally. Hyperperfusion in these areas specifically correlated with eating symptoms severity in patients. Our data did not support a normalizing effect of intranasal OT on perfusion abnormalities in these patients, at least for the specific dose (40 IU) and post-dosing interval (18-26 min) examined. Our findings enhance our understanding of resting brain abnormalities in BN/BED and identify resting rCBF as a non-invasive potential biomarker for disease-related changes and treatment monitoring. They also highlight the need for a comprehensive investigation of intranasal OT pharmacodynamics in women before we can fully ascertain its therapeutic value in disorders affecting predominantly this gender, such as BN/BED.",2020,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","['Twenty-four women with BN/BED and 23 healthy women', 'women with BN/BED compared with healthy controls', 'bulimia nervosa and binge-eating disorder (BN/BED', 'women with bulimia nervosa and binge-eating disorder and healthy controls']","['intranasal OT', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']","['perfusion abnormalities', 'medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally', 'resting rCBF', 'regional cerebral blood flow (rCBF', 'eating symptoms severity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0018427', 'cui_str': 'Structure of cingulate gyrus'}, {'cui': 'C0228261', 'cui_str': 'Structure of long insular gyrus'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",24.0,0.231848,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martins', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rodan', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. yannis.paloyelis@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-020-00871-w'] 1766,32514040,A registered replication study on oxytocin and trust.,"In an influential paper, Kosfeld et al. (2005) showed that intranasal administration of oxytocin (OT) increases the transfers made by investors in the trust game-suggesting that OT increases trust in strangers. Subsequent studies investigating the role of OT in the trust game found inconclusive effects on the trusting behaviour of investors but these studies deviated from the Kosfeld et al. study in an important way-they did not implement minimal social contact (MSC) between the investors and the trustees in the trust game. Here, we performed a large double-blind and placebo-controlled replication study of the effects of OT on trusting behaviour that yields a power of more than 95% and implements an MSC condition as well as a no-social-contact (NoC) condition. We find no effect of OT on trusting behaviour in the MSC condition. Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 19 October 2018. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.11980368.",2020,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.",[],"['OT', 'oxytocin', 'oxytocin (OT', 'placebo']",[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0573493,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.","[{'ForeName': 'Carolyn H', 'Initials': 'CH', 'LastName': 'Declerck', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boone', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Pauwels', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Chair in Empirical Economics and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Laboratory for Social and Neural Systems Research, Department of Economics, University of Zurich, Zurich, Switzerland. ernst.fehr@econ.uzh.ch.'}]",Nature human behaviour,['10.1038/s41562-020-0878-x'] 1767,32518042,Population Pharmacokinetics Analysis of Quetiapine Extended-release Formulation in Japanese Patients with Bipolar Depression.,"PURPOSE The objectives of this study were to explore covariates of plasma quetiapine concentrations after oral administration of quetiapine extended-release formulation (XR), and to examine the exposure-response relationship in Japanese patients with bipolar depression, using population pharmacokinetics (PopPK) modeling. METHODS In a multicenter, randomized, double-blind, placebo-controlled study of quetiapine XR in patients with bipolar depression, plasma for the measurement of quetiapine concentration was collected at weeks 2, 4, 8, 12, 20, 28, and 52 during oral administration of 150 or 300 mg once daily of quetiapine XR before bedtime. A PopPK model of quetiapine XR was developed using nonlinear mixed-effects modeling with first-order conditional estimation with interactions. The exposure-response relationship was examined using post-hoc exposures. The post-hoc AUC estimate was plotted against the change in the Montgomery-Åsberg Depression Rating Scale (ΔMADRS) total score from baseline to 8 weeks following once-daily doses at 300 mg. FINDINGS The final PopPK analysis dataset contained 322 patients and 1162 observations (cutoff data at week 28; cutoff date, February 2016). The plasma quetiapine concentration-time profile in patients with bipolar depression after oral administration of quetiapine XR was represented well using a 1-compartment with first-order absorption model. Covariate analysis led to the selection of γ-glutamyl transpeptidase on apparent oral clearance and body weight on apparent volume of distribution as covariates. The final population mean values of apparent oral clearance and apparent volume of distribution were 87.7 L/h and 277 L, respectively, and the interindividual %CVs were 32.6% and 75.0%, respectively. IMPLICATIONS The effects of covariates on PK parameters were not large compared with the interindividual variability. In addition, there was no clear relationship between the AUC and ΔMADRS. ClinicalTrials.gov identifier: NCT01725308.",2020,"The final population mean values of apparent oral clearance and apparent volume of distribution were 87.7 L/h and 277 L, respectively, and the interindividual %CVs were 32.6% and 75.0%, respectively. ","['patients with bipolar depression, plasma for the measurement of quetiapine concentration was collected at weeks 2, 4, 8, 12, 20, 28, and 52 during oral administration of 150 or 300\xa0mg once daily of', 'Japanese Patients with Bipolar Depression', 'Japanese patients with bipolar depression, using population pharmacokinetics (PopPK) modeling', 'patients with bipolar depression after oral administration of']","['quetiapine extended-release formulation (XR', 'quetiapine XR', 'Quetiapine', 'placebo']","['oral clearance and apparent volume of distribution', 'plasma quetiapine concentrations', 'Montgomery-Åsberg Depression Rating Scale (ΔMADRS) total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1997945', 'cui_str': 'Measurement of quetiapine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1135768', 'cui_str': 'Extended Release Formulations'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0397568,"The final population mean values of apparent oral clearance and apparent volume of distribution were 87.7 L/h and 277 L, respectively, and the interindividual %CVs were 32.6% and 75.0%, respectively. ","[{'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Fukushi', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan. Electronic address: risa.fukushi@astellas.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Katashima', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Komatsu', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc, Ibaraki, Japan.'}, {'ForeName': 'Akitsugu', 'Initials': 'A', 'LastName': 'Takada', 'Affiliation': 'Astellas Pharma Global Development Inc, Northbrook, IL, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.006'] 1768,32518480,The First Additional Port During Single-Incision Laparoscopic Cholecystectomy.,"Background and Objectives Single-incision laparoscopic cholecystectomy (SILC) has become increasingly popular. Regarding the difficulties of SILC in acute cholecystitis, additional port insertion is sometimes required. However, appropriate locations for additional port insertion have not been well studied. In the present study, the safety and effectiveness of the first additional port insertion in the epigastric region during SILC was assessed. Methods Additional port insertions were needed in 52 of 113 patients who underwent SILC for acute cholecystitis. The first port was inserted in the epigastric region and the second (if required) was inserted in the right lateral subcostal area. A drainage catheter was positioned through the epigastric port. Results One additional port was inserted in 43 patients and two additional ports were inserted in 9 patients. Mean operation time was 45.0 minutes in the Pure SILC group and 83.3 minutes in Additional Port group. Mean hospital stay was 3.7 days in the Pure SILC group and 5.9 days in Additional Port group. There was no open conversion. Intra-operative (n = 5) and postoperative bile leakages (n = 2) were identified in six patients. Timing of operation after onset of symptoms was significantly greater in the group with bile duct injury than in those without bile duct injury in patients who required additional ports. Conclusions The first additional port in the epigastric area during SILC for acute cholecystitis helps to complete the operation without open conversion. However, the procedure can be performed safely in selective patients with relatively short duration of symptoms.",2020,Mean hospital stay was 3.7 days in the Pure SILC group and 5.9 days in Additional Port group.,"['43 patients and two additional ports were inserted in 9 patients', '113 patients who underwent SILC for acute cholecystitis']","['incision laparoscopic cholecystectomy (SILC', 'Single-Incision Laparoscopic Cholecystectomy']","['safety and effectiveness', 'Mean operation time', 'postoperative bile leakages', 'Mean hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",2.0,0.0261793,Mean hospital stay was 3.7 days in the Pure SILC group and 5.9 days in Additional Port group.,"[{'ForeName': 'Ju-Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, College of Medicine, Hanyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Gangmi', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Dongguk University Medical Center, Gyeongju, Republic of Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00024'] 1769,32521538,"Colon-delivered short-chain fatty acids attenuate the cortisol response to psychosocial stress in healthy men: a randomized, placebo-controlled trial.","Short-chain fatty acids (SCFAs) are products of microbial fermentation of dietary fiber in the colon and may mediate microbiota-gut-brain communication. However, their role in modulating psychobiological processes that underlie the development of stress- and anxiety-related disorders is not mechanistically studied in humans. In this triple-blind, randomized, placebo-controlled intervention trial, we examine in a parallel group design the effects of 1-week colonic SCFA-mixture delivery in doses equivalent to fermentation of 10 g or 20 g of arabinoxylan oligosaccharides on responses to psychosocial stress and fear tasks in 66 healthy men. We demonstrate that low and high doses of SCFAs significantly attenuate the cortisol response to psychosocial stress compared to placebo. Both doses of SCFAs increase serum SCFA levels and this increase in circulating SCFAs co-varies significantly with the attenuation of the cortisol response to psychosocial stress. Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings. These results demonstrate that colon-delivered SCFAs modulate hypothalamic-pituitary-adrenal axis reactivity to psychosocial stress, thereby supporting their hypothesized role in microbiota-gut-brain communication.",2020,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","['healthy men', '66 healthy men']","['Short-chain fatty acids (SCFAs', 'colonic SCFA-mixture delivery', 'SCFAs', 'Colon-delivered short-chain fatty acids', 'arabinoxylan oligosaccharides', 'placebo']","['fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings', 'cortisol response to psychosocial stress', 'serum SCFA levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.031091,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","[{'ForeName': 'Boushra', 'Initials': 'B', 'LastName': 'Dalile', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Laboratory of Biological Psychology, Brain & Cognition, Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bergonzelli', 'Affiliation': 'Department of Gastrointestinal Health, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Verbeke', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium. lukas.vanoudenhove@kuleuven.be.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0732-x'] 1770,32531253,The stability of children's salivary peptidome profiles in response to short-term beverage consumption.,"BACKGROUND Salivary peptidome profiling analysis has advantages of simplicity and non-invasiveness and great potentiality for screening, monitoring or primary diagnosis of diseases, but may be subjected to change against interferences like diet. METHODS We conducted a 5-day study to investigate the influence of 3 kinds of beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control) on children's salivary peptidome using mass spectrometry techniques. RESULTS All the groups shared a relatively stable pattern in heatmaps during the experimental days. Principal component analysis plot presented slight shifts in all the intervention groups between the baseline and intervention period while samples were not distinctly separated by date. The numbers of significantly changed peptides after short-term orange juice and tea intervention were four and three, respectively, while no changes occurred in the yoghurt group and control. Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS Salivary peptidome has its own stability against beverage intervention, confirming the feasibility and validity of using it as a potential reference for the healthy state of the body, with diet habits recorded and considered as a confounder if necessary.",2020,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS ","[""children's salivary peptidome using mass spectrometry techniques""]","['beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.020256,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS ","[{'ForeName': 'Fangqiao', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Tong', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China. Electronic address: kqzsg86@bjmu.edu.cn.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.06.018'] 1771,32531956,Effect of a Six-Week Intermittent Fasting Intervention Program on the Composition of the Human Body in Women over 60 Years of Age.,"The objective of this research was to determine the effectiveness of intermittent fasting (IF) in reducing body fat and lowering body mass index. An additional objective was to determine the feasibility of applying IF in overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan. This study included a group of 45 women over 60 years of age. The intervention in the experimental group involved complete abstinence from food intake for 16 h per day, from 20:00 p.m. to 12:00 a.m. (the next day). The results demonstrated that the body weight in the subjects in the experimental group (EXP) group decreased by almost 2 kg and this decrease was visible in the remaining parameters related to body fat mass. The skeletal muscle mass did not change significantly, which indicates an actual decrease in the fat mass. The proportion of subjects who did not succeed in following the prescribed diet plan was 12%. The application of intermittent fasting in female subjects over 60 years of age resulted in positive changes in body composition. Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.",2020,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"['Women over 60 Years of Age', 'female subjects over 60 years of age resulted in positive changes in body composition', 'overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan', '45 women over 60 years of age']",['Six-Week Intermittent Fasting Intervention Program'],"['body weight', 'body fat and lowering body mass index', 'Time-restricted feeding (TRF', 'skeletal muscle mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.0208379,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Domaszewski', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Konieczny', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Pakosz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Bączkowicz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, the Jerzy Kukuczka Academy of Physical Education, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17114138'] 1772,32531968,Influence of Music on Closed Motor Skills: A Controlled Study with Novice Female Dart-Throwers.,"The influence of music heard at different tempos is analyzed during the execution of a dart-throwing task. The sample consisted of 56 female university students (Mean age = 23.38, SD = 6.773). The participants were randomly assigned to GC (group control without music; n = 18), GS (group with slow-paced music at a tempo of 60 BPM; n = 19) and GF (group with fast-paced music at a tempo of 105 BPM; n = 19). All participants performed a dart-throwing task in two phases. Analysis of the scores obtained during Phase 1 and Phase 2 of dart throwing (examining both between-group differences and within-group differences, i.e., changes in scores from Phase 1 to Phase 2 using a mixed factorial ANOVA) revealed no differences in dart-throwing scores. There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55) = 4.426, p = 0.017) with a large effect size ( ŋ 2 p = 0.143), although neither of these groups differed from GC. The results are discussed in terms of the role of music in precision tasks and the synchronization of the task with the pace of the music .",2020,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55) = 4.426, p = 0.017) with a large effect size ( ŋ 2 p = 0.143), although neither of these groups differed from GC.","['56 female university students (Mean age = 23.38, SD = 6.773', 'Novice Female Dart-Throwers']","['GC', 'Music', 'GS (group with slow-paced music at a tempo of 60 BPM; n = 19) and GF (group with fast-paced music']","['Closed Motor Skills', 'execution time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336707', 'cui_str': 'Dart'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0076082', 'cui_str': 'tempamine'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0510927,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55) = 4.426, p = 0.017) with a large effect size ( ŋ 2 p = 0.143), although neither of these groups differed from GC.","[{'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Arbinaga', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Nehemías', 'Initials': 'N', 'LastName': 'Romero-Pérez', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Torres-Rosado', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Fernández-Ozcorta', 'Affiliation': 'Department of Physical Activity and Sports, Center for University Studies Cardenal Spínola CEU, University of Seville Attached Centre, 41930 Sevilla, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Mendoza-Sierra', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17114146'] 1773,32532035,Anti-Inflammatory Potential of n-3 Polyunsaturated Fatty Acids Enriched Hen Eggs Consumption in Improving Microvascular Endothelial Function of Healthy Individuals-Clinical Trial.,"The effects of consumption of n-3 polyunsaturated fatty acids (n-3 PUFAs) enriched hen eggs on endothelium-dependent and endothelium-independent vasodilation in microcirculation, and on endothelial activation and inflammation were determined in young healthy individuals. Control group ( N = 21) ate three regular hen eggs/daily (249 mg n-3 PUFAs/day), and n-3 PUFAs group ( N = 19) ate three n-3 PUFAs enriched hen eggs/daily (1053 g n-3 PUFAs/day) for 3 weeks. Skin microvascular blood flow in response to iontophoresis of acetylcholine (AChID; endothelium-dependent) and sodium nitroprusside (SNPID; endothelium-independent) was assessed by laser Doppler flowmetry. Blood pressure (BP), body composition, body fluid status, serum lipid and free fatty acids profile, and inflammatory and endothelial activation markers were measured before and after respective dietary protocol. Results: Serum n-3 PUFAs concentration significantly increased, AChID significantly improved, and SNPID remained unchanged in n-3 PUFAs group, while none was changed in Control group. Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs. BP, fat free mass, and total body water significantly decreased, while fat mass, interleukin-17A (pro-inflammatory), interleukin-10 and vascular endothelial growth factor A significantly increased in the Control group. Other measured parameters remained unchanged in both groups. Favorable anti-inflammatory properties of n-3 PUFAs consumption potentially contribute to the improvement of microvascular endothelium-dependent vasodilation in healthy individuals.",2020,Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs.,"['young healthy individuals', 'Healthy Individuals-Clinical Trial', 'healthy individuals']","['n-3 PUFAs consumption', 'Control group ( N = 21) ate three regular hen eggs/daily (249 mg n-3 PUFAs/day), and n-3 PUFAs group ( N = 19) ate three n-3 PUFAs enriched hen eggs/daily (1053', 'acetylcholine', 'n-3 polyunsaturated fatty acids (n-3 PUFAs', 'Interferon-γ', 'n-3 Polyunsaturated Fatty Acids Enriched Hen Eggs Consumption']","['Blood pressure (BP), body composition, body fluid status, serum lipid and free fatty acids profile, and inflammatory and endothelial activation markers', 'interleukin-10 (anti-inflammatory', 'BP, fat free mass, and total body water significantly decreased, while fat mass, interleukin-17A (pro-inflammatory), interleukin-10 and vascular endothelial growth factor A', 'Microvascular Endothelial Function', 'Serum n-3 PUFAs concentration', 'Skin microvascular blood flow', 'SNPID']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0187711,Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mihalj', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Kolobarić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Šušnjara', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Luka', 'Initials': 'L', 'LastName': 'Kolar', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zrinka', 'Initials': 'Z', 'LastName': 'Mihaljević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Matić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Jukić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zlata', 'Initials': 'Z', 'LastName': 'Kralik', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Grčević', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Kralik', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Vatroslav', 'Initials': 'V', 'LastName': 'Šerić', 'Affiliation': 'Department of Clinical Laboratory Diagnostics, Osijek University Hospital, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Drenjančević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}]",International journal of molecular sciences,['10.3390/ijms21114149'] 1774,32532328,Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham.,"BACKGROUND People with chronic low back pain (LBP) typically have increased pain sensitivity compared to healthy controls, however its unknown if pain sensitivity differs based on LBP trajectory at baseline or after manual therapy interventions. We aimed to compare baseline pressure pain threshold (PPT) and temporal summation (TS) between people without LBP, with episodic LBP, and with persistent LBP, and to compare changes over time in PPT and TS after a lumbar spinal manipulation or sham manipulation in those with LBP. METHODS Participants were aged 18-59, with or without LBP. Those with LBP were categorised as having either episodic or persistent LBP. PPT and TS were tested at baseline. LBP participants then received a lumbar spinal manipulation or sham, after which PPT and TS were re-tested three times over 30 min. Generalised linear mixed models were used to analyse data. RESULTS One hundred participants (49 female) were included and analysed. There were 20 non-LBP participants (mean age 31 yrs), 23 episodic LBP (mean age 35 yrs), and 57 persistent LBP (mean age 37 yrs). There were no significant differences in PPT or TS between groups at baseline. There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability. Changes in PPT and TS after the interventions did not differ between the two LBP groups. DISCUSSION We found no differences between people with no LBP, episodic LBP, or persistent LBP in baseline PPT or TS. Changes in PPT and TS following a lumbar manual therapy intervention do not appear to differ between LBP trajectories. TRIAL REGISTRATION The trial was prospectively registered with ANZCTR (ACTRN12617001094369).",2020,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","['people without LBP, with episodic LBP, and with persistent LBP', 'One hundred participants (49 female) were included and analysed', 'Participants were aged 18-59, with or without LBP', '20 non-LBP participants (mean age 31\u2009yrs), 23 episodic LBP (mean age 35\u2009yrs), and 57 persistent LBP (mean age 37\u2009yrs', 'adults with episodic and persistent low back pain trajectories', 'People with chronic low back pain (LBP']","['LBP', 'lumbar spinal manipulation']","['PPT or TS', 'pain sensitivity', 'Pressure pain threshold and temporal summation', 'baseline pressure pain threshold (PPT) and temporal summation (TS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0443150', 'cui_str': 'Baseline pressure'}]",100.0,0.151039,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia. sasha.aspinall@murdoch.edu.au.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00326-5'] 1775,32532790,A 3-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408.,"PURPOSE We sought to improve upon frontline bendamustine/rituximab (BR) induction therapy followed by rituximab maintenance in untreated high-risk follicular lymphoma (FL). PATIENTS AND METHODS Patients were randomized to BR induction followed by 2-year rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR). Dual primary objectives were complete remission (CR) rate and 1-year disease-free survival (DFS); 289 patients enrolled (NCT01216683). RESULTS For induction, 92%, 87%, and 86% of patients randomized to BR-R , BVR-R , or BR-LR received 6 cycles, respectively. CR rate with BR vs. BVR induction was 62% vs. 75% ( P =0.04). One-year DFS rates with BR-R vs. BR-LR were 85% vs. 67%, respectively ( P =0.0009). This was due to an imbalance in CR rates post-BR induction and discontinuation due to adverse events (AEs). The most common grade 3-4 AEs for BVR vs. BR were neutropenia and sensory neuropathy (12% vs. <1%); 83% of the latter with intravenous bortezomib. The most common grade 3-4 AEs related to LR vs. rituximab maintenance were neutropenia 66% vs. 21% ( P <0.0001) and febrile neutropenia 10% vs. 2% ( P =0.05). The overall treatment-related mortality was 1.4%. With 5-year median follow-up, 3-year PFS rates for BR-R, BVR-R, and BR-LR were 77%, 82%, and 76%, respectively ( P =0.36) with OS rates of 87%, 90%, and 84%, respectively ( P =0.79). For prognostication, CR rate and POD-24 were associated with survival. CONCLUSIONS Altogether, neither bortezomib added to BR induction nor lenalidomide added to rituximab maintenance immediately post-BR induction are recommended in untreated FL.",2020,CR rate with BR vs. BVR induction was 62% vs. 75% ( P =0.04).,"['Untreated Follicular Lymphoma', 'untreated high-risk follicular lymphoma (FL', 'Patients']","['bortezomib', 'Bendamustine/Rituximab with Bortezomib', 'bendamustine/rituximab (BR) induction therapy', 'rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR']","['OS rates', 'febrile neutropenia', 'CR rate and POD-24', 'overall treatment-related mortality', 'neutropenia and sensory neuropathy', 'CR rate with BR vs. BVR induction', '3-year PFS rates for BR-R, BVR-R, and BR-LR', 'complete remission (CR) rate and 1-year disease-free survival']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",289.0,0.0918214,CR rate with BR vs. BVR induction was 62% vs. 75% ( P =0.04).,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Evens', 'Affiliation': 'Division of Blood Disorders, Rutgers Cancer Institute of New Jersey ae378@cinj.rutgers.edu.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana Farber Cancer Institutes.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Medicine, College of Medicine, Mayo Clinic.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine, Stanford University.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Internal Medicine, Division of Hematology, Mayo Clinic.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Quon', 'Affiliation': 'Radiology, Stanford University School of Medicine.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Pathology and Laboratory Medicine, University of Wisconsin School of Medicine.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic.'}, {'ForeName': 'Puneet Singh', 'Initials': 'PS', 'LastName': 'Cheema', 'Affiliation': ""Saint John's Hospital Health East Care System.""}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Dy', 'Affiliation': 'Decatur Memorial Hospital.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': ""O'Brien"", 'Affiliation': 'medicine, University Hospitals Seidman Cancer Center.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University.'}, {'ForeName': 'Terrence P', 'Initials': 'TP', 'LastName': 'Cescon', 'Affiliation': 'McGlinn Cancer Institute, Tower Health.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'Dept of Medicine, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Washington University in St. Louis School of Medicine.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1345'] 1776,32534221,The three-year effect of a single zoledronate infusion on bone mineral density and bone turnover markers following denosumab discontinuation in women with postmenopausal osteoporosis.,"INTRODUCTION In women with postmenopausal osteoporosis denosumab discontinuation is associated with rapid bone loss that could be potentially prevented by a single zoledronate infusion for two years. The longer-term effects, however, of zoledronate treatment are unknown. We aimed to study the effect of a single zoledronate infusion during the third year following denosumab discontinuation, in initially treatment-naive postmenopausal women who became osteopenic after 2.4 ± 0.2 years of denosumab therapy. METHODS We report the 1-year follow-up results of a single arm observational extension of a previously reported 2-year multicenter prospective randomized clinical trial. The primary endpoint of this extension was the change in lumbar spine bone mineral density (LS-BMD); secondary endpoints were changes in femoral neck (FN)-BMD and markers of bone turnover (BTM) during the 3rd year from the zoledronate infusion. Changes are presented as mean and SEM. RESULTS LS-BMD did not change significantly at year 3 compared to year 2 (-1.35 ± 1.1%, p = 1.00) and compared to baseline (-1.96 ± 1.44%, p = 1.00). FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up. In 4 of the 23 studied women BMD values returned to the osteoporotic range at 3 years. CONCLUSIONS A single i.v. infusion of zoledronate 5 mg, given 6 months after the last injection of denosumab therapy maintains for three years BMD gains in the majority of patients previously treated with denosumab for an approximate period of 2.5 years. Follow-up of patients is, however, recommended because about one-fifth of treated women will require additional antiosteoporotic treatment.",2020,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"['women with postmenopausal osteoporosis', 'initially treatment-naive postmenopausal women who became osteopenic after 2.4\u202f±\u202f0.2\u202fyears of denosumab therapy']","['single zoledronate infusion', 'zoledronate infusion', 'denosumab', 'zoledronate', 'denosumab discontinuation']","['CTX values', 'femoral neck (FN)-BMD and markers of bone turnover (BTM', 'FN-BMD values', 'lumbar spine bone mineral density (LS-BMD', 'bone mineral density and bone turnover markers', 'LS-BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",23.0,0.0926873,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"[{'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece. Electronic address: a.anastasilakis@gmail.com.'}]",Bone,['10.1016/j.bone.2020.115478'] 1777,32538267,Naltrexone during pain conditioning: A double-blind placebo-controlled experimental trial.,"Naltrexone reversibly blocks the effects of opioids and has been shown to decrease placebo analgesia. However, it is not clear (1) to what extent naltrexone affects pain modulation in a nontreatment context, for example, in response to pain cues or (2) how naltrexone given prior to pain-cue learning shapes pain responses. In a double-blind procedure prior to pain-cue conditioning, 30 healthy participants were randomized to receive an oral dose of naltrexone (50 mg) or inert pill. During functional magnetic resonance imaging, high and low pain pressures were paired with two different visual cues: a high pain cue and a low pain cue (learning sequence). During a test sequence, medium levels of pressure were used for both cues and the difference in subjective pain ratings following high and low pain cues was calculated. Results showed significant conditioned pain responses across groups ( P  <   .001); however, no significant difference between participants receiving naltrexone or inert pill ( P  =   .193). There was a significant correlation between the difference in high and low pain ratings during the learning sequence and the effect of high and low pain cues during the test sequence (r = .575, P  =   .002). Functional magnetic resonance imaging analyses revealed no significant difference in brain activation between groups. Here, we demonstrate comparable learning of pain responses in participants treated with naltrexone or inert pill. The results point to the possibility that associative learning, and conditional responding to pain cues, is not dependent on endogenous opioids. Our results, using pain-cue conditioning to create reduced pain responses, contrast previous studies where opioid antagonists significantly reduced the placebo effect in treatment of pain.",2020,"Results showed significant conditioned pain responses across groups ( P  <   .001); however, no significant difference between participants receiving naltrexone or inert pill ( P  =   .193).","['participants treated with', '30 healthy participants']","['naltrexone', 'naltrexone (50\u2009mg) or inert pill', 'naltrexone or inert pill', 'Naltrexone', 'placebo']","['pain modulation', 'conditioned pain responses', 'brain activation', 'high and low pain ratings', 'effect of high and low pain cues', 'subjective pain ratings', 'pain responses']","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",30.0,0.262936,"Results showed significant conditioned pain responses across groups ( P  <   .001); however, no significant difference between participants receiving naltrexone or inert pill ( P  =   .193).","[{'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Pontén', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fust', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kosek', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Guterstam', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Molecular pain,['10.1177/1744806920927625'] 1778,32538682,Modified transperitoneal versus retroperitoneal laparoscopic radical nephroureterectomy in the management of upper urinary tract urothelial carcinoma: Best practice in a single center with updated results.,"OBJECTIVE Radical nephroureterectomy remains the gold standard for the surgical treatment of upper urinary tract urothelial carcinoma (UTUC). Based on previous research, we prospectively compared the advantages of transperitoneal laparoscopic radical nephroureterectomy (TLNU) with a three-port technique in a single position versus retroperitoneal laparoscopic radical nephroureterectomy (RLNU). METHODS We evaluated 48 patients diagnosed with UTUC at our institution from January 2015 to October 2019. The patients underwent either TLNU (n = 24) or RLNU (n = 24). We randomly assigned the patients to each technique group based on their body mass index because our experience has shown that the body mass index is the main interfering factor for this surgery. The baseline characteristics and perioperative outcomes were compared between the groups. RESULTS We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups. However, the TLNU group had a shorter operation time and better postoperative pain control than the RLNU group. CONCLUSION Modified TLNU is associated with a shorter operative time and less severe postoperative pain compared with RLNU. Both techniques are safe and reliable with adequate management, and their therapeutic effects are comparable in other aspects.",2020,"We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups.","['48 patients diagnosed with UTUC at our institution from January 2015 to October 2019', 'upper urinary tract urothelial carcinoma', 'upper urinary tract urothelial carcinoma (UTUC']","['Radical nephroureterectomy', 'Modified TLNU', 'transperitoneal laparoscopic radical nephroureterectomy (TLNU', 'Modified transperitoneal versus retroperitoneal laparoscopic radical nephroureterectomy', 'retroperitoneal laparoscopic radical nephroureterectomy (RLNU', 'TLNU', 'RLNU']","['severe postoperative pain', 'shorter operation time and better postoperative pain control', 'baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0027732', 'cui_str': 'Nephroureterectomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",48.0,0.042489,"We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups.","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",The Journal of international medical research,['10.1177/0300060520928788'] 1779,32539487,Cognition test battery: Adjusting for practice and stimulus set effects for varying administration intervals in high performing individuals.,"INTRODUCTION Practice effects associated with the repeated administration of cognitive tests often confound true therapeutic or experimental effects. Alternate test forms help reduce practice effects, but generating stimulus sets with identical properties can be difficult. The main objective of this study was to disentangle practice and stimulus set effects for Cognition , a battery of 10 brief cognitive tests specifically designed for high-performing populations with 15 unique versions for repeated testing. A secondary objective was to investigate the effects of test-retest interval on practice effects. METHODS The 15 versions of Cognition were administered in three groups of 15-16 subjects (total N = 46, mean±SD age 32.5 ± 7.2 years, range 25-54 years, 23 male) in a randomized but balanced fashion with administration intervals of ≥10 days, ≤5 days, or 4 times per day. Mixed effect models were used to investigate linear and logarithmic trends across repeated administrations in key speed and accuracy outcomes, whether these trends differed significantly between administration interval groups, and whether stimulus sets differed significantly in difficulty. RESULTS Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10 Cognition tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain. Stimulus set effects were observed for the 6 Cognition tests that use unique sets of stimuli. Factors were established that allow for correcting for both practice and stimulus set effects. CONCLUSIONS Practice effects are pronounced and probably under-appreciated in cognitive testing. The correction factors established in this study are a unique feature of the Cognition battery that can help avoid masking practice effects, address noise generated by differences in stimulus set difficulty, and facilitate interpretation of results from studies with repeated assessments.",2020,"RESULTS Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10 Cognition tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain.","['high-performing populations with 15 unique versions for repeated testing', '15 versions of Cognition were administered in three groups of 15-16 subjects (total N =\xa046, mean±SD age 32.5\xa0±\xa07.2\xa0years, range 25-54\xa0years, 23 male']",[],['Cognition test battery'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}]",,0.0386009,"RESULTS Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10 Cognition tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Hermosillo', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'Nasrini', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Moore', 'Affiliation': 'Brain Behavior Laboratory, Neuropsychiatry Section, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Brain Behavior Laboratory, Neuropsychiatry Section, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2020.1773765'] 1780,32539520,"In COVID-19, adding lopinavir-ritonavir to usual care did not shorten time to clinical improvement.","SOURCE CITATION Cao B, Wang Y, Wen D, et al. A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19. N Engl J Med. 2020;382:1787-99. 32187464.",2020,A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19. ,['adults hospitalized with severe Covid-19'],['lopinavir-ritonavir'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0270717,A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19. ,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Emory University, Atlanta, Georgia, USA (P.Y., S.T., G.S.M.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Tekwani', 'Affiliation': 'Emory University, Atlanta, Georgia, USA (P.Y., S.T., G.S.M.).'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Emory University, Atlanta, Georgia, USA (P.Y., S.T., G.S.M.).'}]",Annals of internal medicine,['10.7326/ACPJ202006160-063'] 1781,32539588,The Impact of Interactive Shared Book Reading on Children's Language Skills: A Randomized Controlled Trial.,"Purpose Research has indicated that interactive shared book reading can support a wide range of early language skills and that children who are read to regularly in the early years learn language faster, enter school with a larger vocabulary, and become more successful readers at school. Despite the large volume of research suggesting interactive shared reading is beneficial for language development, two fundamental issues remain outstanding: whether shared book reading interventions are equally effective (a) for children from all socioeconomic backgrounds and (b) for a range of language skills. Method To address these issues, we conducted a randomized controlled trial to investigate the effects of two 6-week interactive shared reading interventions on a range of language skills in children across the socioeconomic spectrum. One hundred and fifty children aged between 2;6 and 3;0 (years;months) were randomly assigned to one of three conditions: a pause reading, a dialogic reading, or an active shared reading control condition. Results The findings indicated that the interventions were effective at changing caregiver reading behaviors. However, the interventions did not boost children's language skills over and above the effect of an active reading control condition. There were also no effects of socioeconomic status. Conclusion This randomized controlled trial showed that caregivers from all socioeconomic backgrounds successfully adopted an interactive shared reading style. However, while the interventions were effective at increasing caregivers' use of interactive shared book reading behaviors, this did not have a significant impact on the children's language skills. The findings are discussed in terms of practical implications and future research. Supplemental Material https://doi.org/10.23641/asha.12420539.",2020,"However, the interventions did not boost children's language skills over and above the effect of an active reading control condition.","['children across the socioeconomic spectrum', ""Children's Language Skills"", 'One hundred and fifty children aged between 2;6 and 3;0 (years;months']","['interactive shared reading interventions', 'Supplemental Material https://doi.org/10.23641/asha.12420539', 'Interactive Shared Book Reading', 'pause reading, a dialogic reading, or an active shared reading control condition']","[""children's language skills""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008081', 'cui_str': 'Child Language'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0008081', 'cui_str': 'Child Language'}]",150.0,0.0973005,"However, the interventions did not boost children's language skills over and above the effect of an active reading control condition.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Noble', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Cameron-Faulkner', 'Affiliation': 'School of Arts, Languages and Cultures, The University of Manchester, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jessop', 'Affiliation': 'Language Development Department, Max Planck Institute for Psycholinguistics, Nijmegen, the Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coates', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Sawyer', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Taylor-Ims', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Caroline F', 'Initials': 'CF', 'LastName': 'Rowland', 'Affiliation': 'Language Development Department, Max Planck Institute for Psycholinguistics, Nijmegen, the Netherlands.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00288'] 1782,32501276,"Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.","BACKGROUND Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. OBJECTIVE This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). METHODS A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. RESULTS A moderate decrease was detected in PHQ-9 scores from HLP (β=-3.05; P=.01) and MP (β=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. CONCLUSIONS The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. TRIAL REGISTRATION ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/s12888-015-0475-0.",2020,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","['Depression in Primary Care', 'n=56), and MP (n=54', 'March 2015 and March 2016, with a follow-up of 12 months', 'patients with depression', '221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions']","['HLP', 'Three Low-Intensity, Internet-Based Psychological Interventions', 'PAPP intervention', 'iTAU', 'PAPP', '3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP', 'internet-based psychological interventions (HLP and MP']","['physical SF-12 scores', 'Spanish version of the Patient Health Questionnaire-9', 'PHQ-9 scores', 'visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0270456', 'cui_str': 'Moderate major depression'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0263420', 'cui_str': 'Hyperkeratosis lenticularis perstans'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0135262', 'cui_str': '1-(2-(4-aminophenyl)ethyl)-4-(3-trifluoromethylphenyl)piperazine'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",221.0,0.0776652,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","[{'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Adoración', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Mayoral-Cleries', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barceló-Soler', 'Affiliation': 'Aragón Institute for Health Research (IIS Aragon), Zaragoza, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Hurtado', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'MªTeresa', 'Initials': 'M', 'LastName': 'Navarro', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Villena', 'Affiliation': 'Mental Health Unit of Pozoblaco, Hospital Los Pedroches, Córdoba, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Pérez-Ara', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Riera-Serra', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Rosa Mª', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Biomedical Research Center Network (CIBER) Physiopathology Obesity and Nutrition (CIBERobn), Carlos III Health Institute, Madrid, Spain.'}]",Journal of medical Internet research,['10.2196/15845'] 1783,32502705,The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,"BACKGROUND Current options for effective postoperative analgesia after renal transplantation are limited, due to altered renal clearance and the risk of renal damage. This study compared the analgesic effect of the transversus abdominis plane block, with or without dexmedetomidine, in renal transplant recipients. MATERIALS AND METHODS This prospective randomized double-blinded clinical trial was performed from November 2014 to March 2017. Patients were randomly divided into group C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine). Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia were measured at 2, 4, 6, 12 and 24 h after surgery. RESULTS The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour. Morphine consumption was the highest in group C at all assessed time intervals (p < 0.01). By the 12th hour and 24th hour, morphine consumption (calculated by time interval) was the lowest in group RD (p < 0.05), while no statistical difference was found between groups C and R. The average time to first request of analgesia was the longest and shortest in group RD and group C, respectively (p < 0.01). The overall incidence of nausea and vomiting was the highest in group C (p < 0.05). CONCLUSIONS The transversus abdominis plane block reduced morphine consumption in the first 24 h following renal transplantation, and the addition of dexmedetomidine provided a more effective analgesic effect.",2020,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"['renal transplant recipients', 'November 2014 to March 2017', 'renal transplantation']","['C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine', 'transversus abdominis plane block with or without dexmedetomidine', 'dexmedetomidine', 'transversus abdominis plane block, with or without dexmedetomidine']","['visual analogue pain score', 'Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia', 'nausea and vomiting', 'morphine consumption', 'effective analgesic effect', 'Morphine consumption', 'average time to first request of analgesia']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.113764,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.54 Xianlie South Road, 510060, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Hufei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China. Electronic address: mysjz1@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.073'] 1784,32505126,Striatal activation to monetary reward is associated with alcohol reward sensitivity.,"One well-known phenotypic risk factor for the development of alcohol use disorder is sensitivity to the rewarding effects of alcohol. In the present study, we examined whether individuals who are sensitive to alcohol reward are also sensitive to nondrug rewards, thereby reflecting a broader individual difference risk factor. Specifically, we tested the hypothesis that subjective response to acute rewarding effects of alcohol would be related to neural activation during monetary reward receipt relative to loss (in the absence of alcohol). Community-recruited healthy young social drinkers (N = 58) completed four laboratory sessions in which they received alcohol (0.8 g/kg) and placebo in alternating order under double-blind conditions, providing self-report measures of subjective response to alcohol at regular intervals. At a separate visit 1-3 weeks later, they completed a reward-guessing game, the 'Doors' task, during fMRI in a drug-free state. Participants who reported greater motivation (i.e., wanting) to consume more alcohol after a single moderate dose of alcohol also exhibited greater neural activation in the bilateral ventral caudate and the nucleus accumbens during reward receipt relative to loss. Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking). Our study is the first to show that measures of alcohol reward are related to neural indices of monetary reward in humans. These results support growing evidence that individual differences in responses to drug and nondrug reward are linked and together form a risk profile for drug use or abuse, particularly in young adults.",2020,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","['young adults', 'Community-recruited healthy young social drinkers (N\u2009=\u200958']","['alcohol', 'placebo']","['neural activation', 'subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0330504,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Radoman', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA. mradom3@uic.edu.'}, {'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychology, University of Kentucky, 171 Funkhouser Drive, Lexington, KY, 40506, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, 50N Medical Drive, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841S Maryland Avenue, Chicago, IL, 60637, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0728-6'] 1785,32507404,Presentation and short-term evaluation of an all-in-one patient-specific implant for cranial reconstruction: A randomized controlled trial.,"Cranial reconstruction after bone graft harvesting remains a challenge. A patient-specific implant (PSI) to guide harvesting and reconstruction was evaluated and compared with the use of a free-hand procedure with calcium phosphate cement (C). Patients were randomized to either the PSI or C group. The outcome was measured clinically and radiographically as the primary endpoint. Secondary endpoints were ease of application, patient and surgeon satisfaction, and the complication rate. Twenty patients were randomized to the PSI (n=10) and C (n=10) groups. Two PSI patients were switched to the cement group due to a poor fit of the PSI. There was a non-significant trend towards more successful outcomes in the PSI group. Two PSI patients presented palpable screws, and one cement patient had a palpable dimple. Cone beam computed tomography showed a significantly lower median volume discrepancy in the PSI group (P<0.0001). The total surgical manipulation time was significantly higher in the PSI group. At 10 days postoperative, three PSI and two C patients presented with minor postoperative complications. There was no significant difference in patient or surgeon satisfaction. PSIs are a reliable alternative to cement. This PSI is novel as it also serves as a guide for harvesting the bone blocks required for reconstructive purposes.",2020,Cone beam computed tomography showed a significantly lower median volume discrepancy in the PSI group (P<0.0001).,"['cranial reconstruction', 'Twenty patients were randomized to the PSI (n=10) and C (n=10) groups']",['calcium phosphate cement (C'],"['patient or surgeon satisfaction', 'total surgical manipulation time', 'ease of application, patient and surgeon satisfaction, and the complication rate', 'postoperative complications', 'successful outcomes', 'median volume discrepancy']","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]",20.0,0.029954,Cone beam computed tomography showed a significantly lower median volume discrepancy in the PSI group (P<0.0001).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'De Cuyper', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium. Electronic address: brecht.decuyper@gmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pottel', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Würsching', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abeloos', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'De Ceulaer', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Neyt', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lamoral', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Swennen', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.04.002'] 1786,32510741,Effectiveness of postpartum sexual health education programme structured according to Levine's conservation model: An interventional study.,"AIM This study aimed to determine the effects of a postpartum sexual health education programme structured according to Levine's conservation model on postpartum women. METHODS The interventional study was completed with 67 postpartum women. The intervention group was given the postpartum sexual health education programme structured according to Levine's conservation model. The control group received routine discharge training. The data were collected using a personal information form, The Index of Female Sexual Function, Arizona Sexual Experience Scale and Golombok-Rust Inventory of Sexual Satisfaction. RESULTS It has been determined that the decrease in sexual arousal and desire is the first among postpartum sexual problems experienced by women. This study demonstrated that sexual function, sexual satisfaction and sexual response were higher in nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters. After the programme, the intervention group had more adequate sexual function, and they developed a strong, easy and satisfactory sexual response than the control group (p < 0.05). CONCLUSION This programme was effective in increasing the sexual functions and satisfaction of the postpartum women. Models provide guidance to nurses for provision of care in a systematic manner.",2020,"This study demonstrated that sexual function, sexual satisfaction and sexual response were higher in nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters.","['nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters', 'postpartum women', '67 postpartum women']","['routine discharge training', 'postpartum sexual health education programme', ""postpartum sexual health education programme structured according to Levine's conservation model""]","['sexual function, sexual satisfaction and sexual response', 'adequate sexual function', 'sexual functions and satisfaction', 'Index of Female Sexual Function, Arizona Sexual Experience Scale and Golombok-Rust Inventory of Sexual Satisfaction', 'sexual arousal and desire', 'satisfactory sexual response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0319862', 'cui_str': 'Order Uredinales'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation'}]",67.0,0.019486,"This study demonstrated that sexual function, sexual satisfaction and sexual response were higher in nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters.","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Evcili', 'Affiliation': 'Vocational School of Health Care Services, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Gulbahtiyar', 'Initials': 'G', 'LastName': 'Demirel', 'Affiliation': 'Faculty of Health Sciences, Midwifery Department, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Bekar', 'Affiliation': 'Faculty of Health Sciences, Midwifery Department, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Guler', 'Affiliation': 'Faculty of Health Sciences, Midwifery Department, Cumhuriyet University, Sivas, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12855'] 1787,32505785,Effect of a 10-month residential multidisciplinary weight loss intervention on food reward in adolescents with obesity.,"BACKGROUND While multidisciplinary weight loss (WL) programs have been suggested to improve the sensitivity of appetite control system, this study examined for the first time the effect of a specific multidisciplinary intervention on the hedonic aspects of food intake in adolescents with obesity. STUDY DESIGN Twenty-four adolescents (11-15 years) with obesity (mean BMI: 35.7 ± 4.5 kg/m 2 ; BMI percentile: 98.7 ± 0.5) took part in a 10-month inpatient WL program, which included physical activity, nutritional education and psychological support. Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits were assessed at baseline, 5 months and at the end of the 10-month intervention. Analyses were conducted with linear mixed models and paired t-tests. RESULTS The mean WL was 8.9 ± 6.9 kg. Appetite sensations and pre-meal hedonic ratings of liking for all food categories (HF: high-fat; LF: low-fat; SA: savory; SW: sweet) increased after 5 months (fasting hunger, p = 0.02; fasting desire to eat, p = 0.01; daily hunger, p = 0.001; pre-meal liking for HFSA, p = 0.03; LFSA, p = 0.04; HFSW, p = 0.009; LFSW, p = 0.005). In contrast, appetite sensations (fasting and daily), emotional eating (p < 0.001), uncontrolled eating (p = 0.009), and pre-meal explicit liking (for all food categories) decreased between months 5 and 10. Post-meal liking for HFSA (p < 0.001), LFSA (p = 0.002), HFSW (p = 0.02) and LFSW (p < 0.001) decreased between baseline and month 5 and remained unchanged between months 5 and 10. CONCLUSION These findings suggest that adaptive mechanisms to WL occurring in the short-to-medium term are attenuated in the longer term with the persistence of WL. These results indicate improvements in the reward response to food in adolescents with obesity and may contribute to the beneficial effect of multicomponent WL interventions in this population. Future studies are required to confirm these findings and elucidate underlying mechanisms.",2020,Post-meal liking for HFSA (p<0.001),"['adolescents with obesity', 'Twenty-four adolescents (11-15 years) with obesity']",['residential multidisciplinary weight loss intervention'],"['Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits', 'appetite sensations (fasting and daily), emotional eating (p<0.001), uncontrolled eating (p=0.009), and pre-meal explicit liking', 'HFSW', 'Appetite sensations and pre-meal hedonic ratings of liking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",24.0,0.0263658,Post-meal liking for HFSA (p<0.001),"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France. Electronic address: maud.miguet@neuro.uu.se.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Department of Human Nutrition, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112996'] 1788,32511829,The acute muscular response to passive movement and blood flow restriction.,"PURPOSE To compare the acute effects of passive movement combined with blood flow restriction (PM + BFR) to passive movement (PM) or blood flow restriction alone (BFR). METHODS A total of 20 healthy participants completed: time control (TC), PM, BFR and PM + BFR (one per leg, over 2 days; randomized). For PM, a dynamometer moved the leg through 3 sets of 15 knee extensions/flexions (90° at 45°/second). For BFR, a cuff was inflated to 80% arterial occlusion pressure on the upper leg. Measurements consisted of anterior muscle thickness at 60% and 70% of the upper leg before and after (-0, -5 and -10 min) conditions, ratings of perceived effort and discomfort before conditions and after each set, and of the vastus lateralis during conditions. Data, presented as mean (SD), were compared using Bayesian RMANOVA, except for perceived effort and discomfort, which were compared using a Friedman's test (non-parametric). RESULTS 60% (Δcm before-after-0: TC = 0.04 [0.09], PM = -0.01 [0.15], BFR = 0.00 [0.11], PM + BFR = 0.01 [0.22]) and 70% (Δcm before-after-0: TC = 0.01 [0.09], PM = -0.01 [0.15], BFR = 0.02 [0.11], PM + BFR = -0.03 [0.22]) muscle thickness did not change. Perceived effort was greater than TC following PM (p = .05) and PM + BFR (p = .001). Perceived discomfort was greater following BFR and PM + BFR compared to TC (all p ≤ .002) and PM (all p ≤ .010). Changes in deoxygenation (e.g. channel 1; ΔμM start set 1-end set 3: TC = 0.9 [1.2], PM = -1.2 [1.9], BFR = 10.3 [2.7], PM + BFR = 10.3 [3.0]) were generally greater with BFR and PM + BFR (BF inclusion  = 1.210e + 13). CONCLUSION Acute muscular responses to PM + BFR are not augmented over the effect of BFR alone.",2020,Perceived discomfort was greater following BFR and PM+BFR compared to TC (all p≤0.002) and PM (all p≤0.010).,['20 healthy participants completed'],['passive movement combined with blood flow restriction (PM+BFR) to passive movement (PM) or blood flow restriction alone (BFR'],"['Perceived discomfort', 'Acute Muscular Response to Passive Movement and Blood Flow Restriction', 'time control (TC), PM, BFR, and PM+BFR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",20.0,0.0243963,Perceived discomfort was greater following BFR and PM+BFR compared to TC (all p≤0.002) and PM (all p≤0.010).,"[{'ForeName': 'Joonsun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Applied Physiology Laboratory, School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Daphney M', 'Initials': 'DM', 'LastName': 'Stanford', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Buckner', 'Affiliation': 'USF Muscle Laboratory, Division of Exercise Science, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Jessee', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS, USA.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12649'] 1789,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143'] 1790,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG). METHODS Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test. RESULTS Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05). CONCLUSIONS It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572'] 1791,32513495,Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture.,"PURPOSE Current treatment guidelines recommend treatment for postmenopausal women with a T score <2.5 regardless of age. This subgroup analysis evaluated the efficacy and safety of abaloparatide in younger postmenopausal women considered to be at high risk for fracture. METHODS Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization). FINDINGS A total of 296 women (age range, 49-64 years) were included. Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites). Fracture rates were numerically lower for abaloparatide versus placebo, consistent with the overall trial results, although the differences were not statistically significant. The number needed to treat to prevent 1 additional vertebral fracture after 18 months of treatment versus placebo was 18 for abaloparatide and 21 for teriparatide. The number needed to treat had nonsignificant trends toward lower values with abaloparatide versus teriparatide for nonvertebral fractures (23 vs 40) and clinical fractures (16 vs 73) and similar for major osteoporotic fractures (24 vs 27). The safety profile was consistent with the overall ACTIVE population. IMPLICATIONS Findings of this subgroup (post hoc) analysis are consistent with the overall ACTIVE population. Abaloparatide appears to be effective and well tolerated in this subgroup of younger postmenopausal women. ClinicalTrials.gov identifier: NCT01343004.",2020,"Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites).","['Women with Osteoporosis at High Risk for Fracture', 'postmenopausal women with a T score <2.5 regardless of age', 'Younger Postmenopausal', 'younger postmenopausal women', 'Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization', '296 women (age range, 49-64 years) were included']","['placebo', 'teriparatide', 'abaloparatide versus teriparatide', 'Abaloparatide']","['bone mineral density', 'Fracture rates', 'clinical fractures', 'number needed to treat to prevent 1 additional vertebral fracture', 'Bone Mineral Density and Fracture Incidence', 'major osteoporotic fractures', 'efficacy and safety of abaloparatide', 'nonvertebral fractures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}]",296.0,0.32921,"Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites).","[{'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Setareh A', 'Initials': 'SA', 'LastName': 'Williams', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Weiss', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA. Electronic address: rweiss@radiuspharm.com.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.012'] 1792,32516497,Usefulness of home-use microneedle devices in the treatment of pattern hair loss.,"BACKGROUND Microneedle devices have been used to reduce scarring and wrinkling as well as for the treatment of pattern hair loss. AIMS Here, we investigated the efficacy and safety of a newly developed home-use microneedle device for the treatment of pattern hair loss. METHODS Twenty-nine patients were assigned into three groups based on block randomization: home-use microneedle device only, a combination of home-use microneedle device and 5% minoxidil solution and 5% minoxidil topical solution only. Each treatment was performed twice a week. The study outcomes included hair counts, patient self-assessments, and adverse events at baseline and at 6 months. Statistical analyses were performed using analysis of variance (ANOVA), repeated measures ANOVA and Kruskal-Wallis test. RESULTS The improvements in hair count were seen in the combination group at month 6, but the differences observed did not reach statistical significance in each group and among the three groups. The patient self-assessment showed the highest score in the combination group, but it did not reveal a statistically significant difference among the three groups. Mild and transient pruritus were reported by one patient who was using the microneedle device only. CONCLUSIONS Our study shows that the home-use microneedle device may be a safe and 5% minoxidil solution penetration-enhancing therapeutic modality for stimulating hair growth.",2020,"The patient self-assessment showed the highest score in the combination group, but it did not reveal a statistically significant difference among the three groups.","['pattern hair loss', 'Twenty-nine patients']","['block randomization: home-use microneedle device only, a combination of home-use microneedle device and 5% minoxidil solution and 5% minoxidil topical solution only']","['efficacy and safety', 'Mild and transient pruritus', 'hair count', 'hair counts, patient self-assessments and adverse events']","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",29.0,0.0324985,"The patient self-assessment showed the highest score in the combination group, but it did not reveal a statistically significant difference among the three groups.","[{'ForeName': 'Chihyeon', 'Initials': 'C', 'LastName': 'Sohng', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Eun Hye', 'Initials': 'EH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Soo Kyeong', 'Initials': 'SK', 'LastName': 'Woo', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Kyung Duck', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Seok-Jong', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Weon Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13540'] 1793,32517453,[A Prospective Study of Da Vinci Surgical Robotic System with Chest Wall External Nursing Interventions].,"BACKGROUND Minimally invasive and rapid recovery are trends in surgical treatment of lung cancer, and Da Vinci Surgical Robotic System plays an important role in them. This study was planned to explore the effect of chest wall external nursing interventions on reducing postoperative thoracic drainage and promoting rapid recovery of patients. METHODS The patients who underwent robotic radical lung cancer resection in our hospital from November 2017 to April 2018were randomly divided into two groups. The control group received robotic radical lung cancer resection with abdominal bands wrapped around the chest. The experimental group underwent Da Vinci robotic radical lung cancer surgery and assisted chest wall external nursing interventions after surgery. RESULTS The total and average daily drainage of the experimental group were less than those of the control group. Both the extubation time and the hospitalization time were shorter than those of the control group, but there was no significant difference. The pain score in the second days after operation of the experimental group was slightly higher than that of the control group, with no significant statistical difference. For patients whose chest wall thickness is less than 4 cm, mirabilite external application can significantly reduce the average daily and total drainage volume, but there is no significant difference in extubation time and hospitalization time. CONCLUSIONS Chest wall external nursing interventions are beneficial to the recovery of patients undergoing Vinci robotic lung cancer surgery. Especially for patients with thinner chest wall. It can reduce postoperative drainage, shorten tube retention time and accelerate discharge. Further improvement is expected to achieve better clinical results.",2020,"The pain score in the second days after operation of the experimental group was slightly higher than that of the control group, with no significant statistical difference.","['patients', 'patients with thinner chest wall', 'patients undergoing Vinci robotic lung cancer surgery']","['chest wall external nursing interventions', 'Da Vinci robotic radical lung cancer surgery and assisted chest wall external nursing interventions after surgery', 'Da Vinci Surgical Robotic System with Chest Wall External Nursing Interventions', 'Chest wall external nursing interventions', 'robotic radical lung cancer resection with abdominal bands wrapped around the chest', 'robotic radical lung cancer resection']","['extubation time and the hospitalization time', 'postoperative drainage, shorten tube retention time and accelerate discharge', 'postoperative thoracic drainage', 'total and average daily drainage', 'average daily and total drainage volume', 'extubation time and hospitalization time', 'pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0110548,"The pain score in the second days after operation of the experimental group was slightly higher than that of the control group, with no significant statistical difference.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Meng', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2020.101.07'] 1794,32520354,Autologous bone marrow cell transplantation in the treatment of HIV patients with compensated cirrhosis.,"Liver stem cell therapy is a promising tool to improve decompensated liver cirrhosis (DLC). Especially in patients infected with human immunodeficiency virus (HIV), the condition of the liver may be aggravated by antiretroviral therapy. A total of 21 patients diagnosed with DLC and HIV infection were divided into two groups as follows: those who received (combination therapy group, 14 patients) and those who did not receive (routine therapy group, 7 patients) bone marrow cell transplantation through the portal vein. Two patients died of surgery-related complications in the combination therapy group. The results showed that the survival rate was 85.7% in the combination therapy group after 2 years of follow-up, which was significantly higher than the 14.3% in the conventional therapy group (P<0.01). After treatment, the liver function score decreased significantly in the combination therapy group at 1 (t = 4.276, P = 0.000), 3 (t = 9.153, P = 0.000), and 12 (t = 13.536, P = 0.000) months, the levels of albumin were significantly increased, and the total bilirubin level and prothrombin time were significantly reduced or shortened as compared with the routine therapy group (P<0.05 or <0.01). The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared with the routine therapy group (P<0.05 or <0.01). In summary, the combination therapy is effective in HIV-infected patients with DLC and useful for the recovery of liver function and cellular immune function but may increase the risk of severe complications after surgery.",2020,"The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared to the routine therapy group (P<0.05 or <0.01).","['patients infected with human immunodeficiency virus (HIV', 'HIV patients with compensated cirrhosis', '21 patients diagnosed with DLC and HIV infection']","['Liver stem cell therapy', 'Autologous bone marrow cell transplantation', 'bone marrow cell transplantation through the portal vein']","['total bilirubin level and prothrombin time', 'liver function score', 'levels of albumin', 'white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels', 'survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1258861', 'cui_str': 'Transplantation, Bone Marrow Cell'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}]","[{'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",21.0,0.0173503,"The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared to the routine therapy group (P<0.05 or <0.01).","[{'ForeName': 'Baochi', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Mingrong', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': ""Department of General Surgery, Jiangqiao Hospital of Jiading District, Jiading Branch of Shanghai First People's Hospital, Shanghai 201803, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': 'Department of Surgery, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Shijia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}]",Bioscience reports,['10.1042/BSR20191316'] 1795,32521745,"Effects of 6 Weeks of Traditional Resistance Training or High Intensity Interval Resistance Training on Body Composition, Aerobic Power and Strength in Healthy Young Subjects: A Randomized Parallel Trial.","Consistent practice of physical activity has well known positive effects on general health; however, time for exercise remains one major barrier for many. An acute bout of high intensity interval resistance training (HIIRT) increases acute resting energy expenditure (REE) and decreases respiratory ratio (RR), suggesting its potential role on weight loss and increased fatty acid oxidation. The aim of this study was to test the long-term effect of HIIRT on body composition, lipid profile and muscle strength using a randomized parallel trial. Twenty healthy young adults (22.15 1.95 years) were randomized to perform either a HIIRT ( N = 11) protocol, consisting of three sets of 6 repetitions at 6 repetition maximum (RM) and then 20 seconds of rest between repetitions until exhaustion repeated for 3 times with 2'30″ rest between sets or a traditional training (TRT, N = 9) protocol of 3 sets of 15 reps with 75 sec of rest between sets. Body composition, resting energy metabolism, aerobic capacity, muscle strength and blood measurements were taken before and after 8 weeks of training. Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%, p < 0.05) and lean body mass (+2.82%, p < 0.05). REE and RR were unaltered as lipid profile. HIIRT represents a valid training method to improve muscle strength and mass, but its role on body weight control was not confirmed.",2020,"Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%, p < 0.05) and lean body mass (+2.82%, p < 0.05).","['Twenty healthy young adults (22.15 1.95 years', 'Healthy Young Subjects']","['high intensity interval resistance training (HIIRT', 'HIIRT', 'Traditional Resistance Training or High Intensity Interval Resistance Training']","['Body Composition, Aerobic Power and Strength', 'Body composition, resting energy metabolism, aerobic capacity, muscle strength and blood measurements', 'endurance strength performance', 'lean body mass', 'weight loss and increased fatty acid oxidation', 'body composition, lipid profile and muscle strength', 'muscle strength', 'REE and RR']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0429743', 'cui_str': 'Respiratory ratio'}]",20.0,0.041387,"Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%, p < 0.05) and lean body mass (+2.82%, p < 0.05).","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Moro', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marcolin', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo, 90133 Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bolzetta', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Berton', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Sergi', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Paoli', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17114093'] 1796,32521785,An Exploration of the Effectiveness of a Peer-Led Pain Management Program (PAP) for Nursing Home Residents with Chronic Pain and an Evaluation of Their Experiences: A Pilot Randomized Controlled Trial.,"Background: 80% of nursing home residents have reported chronic pain, which is often accepted by older adults as part of aging. Peer support models are being used to help individuals manage their chronic conditions and overcome the challenges of limited healthcare resources. The aims of this study were: (i) to examine the effectiveness of a 12 week peer-led pain management program (PAP) for nursing home residents and (ii) to evaluate their experiences. Methods: A cluster randomized controlled trial (RCT) was used. The 12 week pain management program was provided for the experimental group. Outcomes were measured at three time points. The participants' satisfaction and acceptance were evaluated by a semi-structured interview after the program was completed. Results: Pain self-efficacy, pain intensity, pain interference, pain knowledge, and depression levels improved after the completion of the 12 week peer-led PAP. The pain-intensity level reported at week 12 was significantly lower in the experimental group than in the control group. Semi-structured interviews showed that the nursing home residents were satisfied with the pain education that they received. Conclusions: The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.",2020,"The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.",['Nursing Home Residents with Chronic Pain and an Evaluation of Their Experiences'],"['12 week peer-led pain management program (PAP', 'Peer-Led Pain Management Program (PAP']","['pain-related and psychological outcome measures', 'pain-intensity level', 'chronic pain', 'Pain self-efficacy, pain intensity, pain interference, pain knowledge, and depression levels']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",,0.0648035,"The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.","[{'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Shuk Kwan', 'Initials': 'SK', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Shamay S M', 'Initials': 'SSM', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lo', 'Affiliation': 'Department of Geriatrics and Palliative Medicine, Shatin Hospital, Hospital Authority, Kowloon, Hong Kong, China.'}, {'ForeName': 'Suey Shuk Yu', 'Initials': 'SSY', 'LastName': 'Yeung', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, 1081 HV Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17114090'] 1797,32540634,"A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults.","OBJECTIVE Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS. METHODS In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis. RESULTS A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01). CONCLUSIONS Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study. TRIAL REGISTRATION Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.",2020,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","['subjects with NRS', 'healthy subjects', 'healthy adults', '150 healthy subjects scoring high on non-restorative sleep measures', '144 subjects completed the study, with no dropouts due to adverse events']","['standardized ashwagandha extract (Shoden®', 'ashwagandha (Withania somnifera) extract', 'placebo']","['Sleep actigraphy', 'Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale', 'total sleep time', 'overall quality of sleep', 'onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset', 'overall sleep quality', 'sleep latency', 'adverse events', 'quality of life (QOL) scores', 'sleep quality', 'self-reported sleep quality', 'sleep efficiency (SE']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",150.0,0.234196,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India. Electronic address: abhijitd1965@gmail.com.'}, {'ForeName': 'Nushafreen', 'Initials': 'N', 'LastName': 'Irani', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Balkrishnan', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar PO, Thrissur, Kerala, 680555, India.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.012'] 1798,32540685,"Impact of the group intervention ""Accept Voices©"" for the management of auditory hallucinations.","AIM OF THE STUDY The objective of this study was to evaluate the potential impact of a third wave CBT group intervention for the management of auditory hallucinations in patients with schizophrenia. METHOD 38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on acceptance and engagement therapy (ACT). The study followed a repeated single case experimental design (type A-B-A) based on the principle of a control phase followed by an intervention phase and a follow-up phase of similar duration. The various measurements were administered during the control phase, at pre-/post-group and six weeks after the last group session. RESULTS The results show a significant decrease in auditory hallucinations, as measured by the PSYRATS scale, during the treatment and follow-up phase, compared to the control phase. In addition, the participants saw significant reductions in depressive and anxious symptomatology (assessed with CDSS and SEAS), and increases in coping and acceptance in regards to voices (assessed using a study scale and VAAS). The level of Malevolence beliefs about voices (measured with BAVQ-R) also decreased significantly. CONCLUSIONS A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.",2020,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","['patients with schizophrenia', '38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on']","['acceptance and engagement therapy (ACT', 'CBT group intervention']","['depressive and anxious symptomatology', 'auditory hallucinations', 'level of Malevolence beliefs about voices (measured with BAVQ-R', 'coping and acceptance', 'intensity of auditory hallucinations, depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",38.0,0.0263279,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Langlois', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France. Electronic address: thomas.langlois@univ-tlse2.fr.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sanchez-Rodriguez', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bourcier', 'Affiliation': 'CHU Toulouse Purpan, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'Centre médical la Villanelle, Cornebarrieu, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Université de Montréal, Montréal, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2020.113159'] 1799,32540720,Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis.,"OBJECTIVE The gait recovery in spinal cord injury (SCI) seems to be partially related to the reorganization of cerebral function; however, the neural mechanisms and the respective biomarkers are not well known. This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI. We tested this hypothesis at baseline in SCI subjects and also in response to cortical stimulation with transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT). METHODS In this neurophysiological analysis of a randomized controlled trial, thirty-nine patients with incomplete SCI were included. They received 30 sessions of either active or sham anodal tDCS over the primary motor area for 20 min combined with RAGT. We analyzed the Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II). Univariate and multivariate linear/logistic regression analyses were performed to identify the predictors of gait function and recovery. RESULTS Consistent with our hypothesis, we found that in the sensorimotor area: (1) Anodal tDCS combined with RAGT can modulate high-beta EEG oscillations power and enhance gait recovery; (2) higher high-beta EEG oscillations power at baseline can predict baseline gait function; (3) high-beta EEG oscillations power at baseline can predict gait recovery - the higher power at baseline, the better gait recovery; (4) decreases in relative high-beta power and increases in beta power decrease during walking are associated with gait recovery. CONCLUSIONS Enhanced EEG beta oscillations in the sensorimotor area in SCI subjects may be part of a compensatory mechanism to enhance local plasticity. Our results point to the direction that interventions enhancing local plasticity such as tDCS combined with robotic training also lead to an immediate increase in sensorimotor cortex activation, improvement in gait recovery, and subsequent decrease in high-beta power. These findings suggest that beta-band oscillations may be potential biomarkers of gait function and recovery in SCI. SIGNIFICANCE These findings are significant for rehabilitation in SCI patients, and as EEG is a portable, inexpensive, and easy-to-apply system, the clinical translation is feasible to follow better the recovery process and to help to individualize rehabilitation therapies of SCI patients.",2020,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"['thirty-nine patients with incomplete SCI were included', 'spinal cord injury patients', 'SCI subjects', 'spinal cord injury (SCI', 'SCI patients']","['active or sham anodal tDCS over the primary motor area for 20\xa0min combined with RAGT', 'transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT']","['high-beta EEG oscillations power and enhance gait recovery', 'Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II', 'gait recovery', 'sensorimotor cortex activation']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}]",39.0,0.0972225,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Simis', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur-Kucukseymen', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud. Lima, Peru.'}, {'ForeName': 'Linamara R', 'Initials': 'LR', 'LastName': 'Battistella', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: Fregni.Felipe@mgh.harvard.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.04.166'] 1800,32540887,"Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial.","INTRODUCTION Labour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae. METHODS AND ANALYSIS This randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively. ETHICS AND DISSEMINATION Ethical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019-169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals. TRIAL REGISTRATION NUMBER ISRCTN87414969, registered 3 May 2019.",2020,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"['Eligible and consenting patients', 'primigravidae during the first stage of labour in Saudi Arabia', 'labour experiences of primigravidae', 'Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM', 'Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics']","['breathing exercises, foot reflexology and back massage (BRM', 'BRM and standard labour care, and a control group receiving only standard labour care', 'pethidine']","['labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6\u2009cm) and post BRM hourly for 2\u2009hours', 'maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction', 'mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively', 'labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}]","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.157332,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"[{'ForeName': 'Kamilya Jamel', 'Initials': 'KJ', 'LastName': 'Baljon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Muhammad Hibatullah', 'Initials': 'MH', 'LastName': 'Romli', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Adibah Hanim', 'Initials': 'AH', 'LastName': 'Ismail', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Khuan', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Boon How', 'Initials': 'BH', 'LastName': 'Chew', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia chewboonhow@upm.edu.my.'}]",BMJ open,['10.1136/bmjopen-2019-033844'] 1801,32534972,"Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter, Randomized Trial.","PURPOSE To compare clinical performance of 2 widely used symmetric-tip hemodialysis catheters. MATERIALS AND METHODS Patients with end-stage renal disease initiating or resuming hemodialysis were randomized to receive an Arrow-Clark VectorFlow (n = 50) or Palindrome catheter (n = 50). Primary outcome was 90-d primary unassisted catheter patency. Secondary outcomes were Kt/V ([dialyzer urea clearance × total treatment time]/total volume of urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ). RESULTS Primary unassisted patency rates with the VectorFlow catheter at 30, 60, and 90 d were 95.5% ± 3.3, 87.2% ± 7.3, and 80.6% ± 9.8, respectively, compared with 89.1% ± 6.2, 79.4% ± 10.0, and 71.5% ± 12.6 with the Palindrome catheter (P = .20). Patients with VectorFlow catheters had a mean Kt/V of 1.5 at 30-, 60-, and 90-day time points, significantly higher than the mean Kt/V of 1.3 among those with Palindrome catheters (P = .0003). URRs were not significantly different between catheters. Catheter Q B rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min). Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal, within the 90-day primary outcome occurred in 3 VectorFlow subjects and 5 Palindrome subjects (P = .72). Infection rates were similar, with 0.98 infections per 1,000 catheter days for VectorFlow catheters compared with 2.62 per 1,000 catheter days for Palindrome catheters (P = .44). CONCLUSIONS The 90-day primary patency rates of Palindrome and VectorFlow catheters were not significantly different, and both achieved sustained high Q B through 90 day follow-up. However, dialysis adequacy based on Kt/V was consistently better with the VectorFlow catheter versus the Palindrome.",2020,"Catheter Q B rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).",['Patients with end-stage renal disease initiating or resuming hemodialysis'],"['VectorFlow catheters', 'VectorFlow catheter versus the Palindrome', 'Arrow-Clark VectorFlow (n\xa0= 50) or Palindrome catheter', 'VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters']","['Kt/V ([dialyzer urea clearance', '90-day primary patency rates of Palindrome and VectorFlow catheters', 'patency rates', '90-d primary unassisted catheter patency', 'Infection rates', 'Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal', 'urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ', 'URRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0336721', 'cui_str': 'Arrow'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0179747', 'cui_str': 'Dialysis catheter'}]","[{'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0429664', 'cui_str': 'Urea reduction ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.066622,"Catheter Q B rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Nadolski', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104. Electronic address: gregory.nadolski@pennmedicine.upenn.edu.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Shin', 'Affiliation': 'Penn State Health Radiology, Hershey, Pennsylvania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Shamimi-Noori', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Vance', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hammelman', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Timothy W I', 'Initials': 'TWI', 'LastName': 'Clark', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rudnick', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.001'] 1802,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177'] 1803,32505660,Frontal-midline theta frequency and probabilistic learning: A transcranial alternating current stimulation study.,"Probabilistic learning is a fundamental cognitive ability that extracts and represents regularities of our environment enabling predictive processing during perception and acquisition of perceptual, motor, cognitive, and social skills. Previous studies show competition between neural networks related to executive function/working memory vs. probabilistic learning. Theta synchronization has been associated with the former while desynchronization with the latter in correlational studies. In the present paper our aim was to test causal relationship between fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation. We hypothesize that theta synchronization disrupts probabilistic learning performance by modulating the competitive relationship. Twenty-six young adults performed the Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning in two sessions that took place one week apart. Stimulation was applied in a double-blind cross-over within-subject design with an active theta tACS and a sham stimulation in a counter-balanced order between participants. Sinusoidal current was administered with 1 mA peak-to-peak intensity throughout the task (approximately 20 min) for the active stimulation and 30 s for the sham. We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation. To influence probabilistic learning, we suggest applying higher current intensity and stimulation parameters more precisely aligned to endogenous brain activity for future studies.",2020,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,['Twenty-six young adults'],"['fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation', 'probabilistic learning', 'fronto-parietal midline theta tACS', 'Probabilistic learning', 'Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning']",['probabilistic learning performance'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",26.0,0.103353,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,"[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Zavecz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Horváth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Solymosi', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janacsek', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Centre of Thinking and Learning, Institute for Lifecourse Development, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Dezso', 'Initials': 'D', 'LastName': 'Nemeth', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Lyon Neuroscience Research Center (CRNL), INSERM, CNRS, Université Claude Bernard Lyon 1, Lyon, France. Electronic address: dezso.nemeth@univ-lyon1.fr.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112733'] 1804,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes. OBJECTIVES We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL). METHODS 46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS. RESULTS There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion. CONCLUSIONS Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015'] 1805,32512234,Oxygen supplementation increases the total work and muscle damage markers but reduces the inflammatory response in COPD patients.,"INTRODUCTION Oxygen supplementation (O 2 -Suppl) is recommended for pulmonary rehabilitation with higher exercise intensities. However, high-intensity exercise tends toward muscle damage and a greater inflammatory response. We aimed to investigate the effect of O 2 -Suppl during exercise test (EET) on CRP level and muscle damage (CPK, LDH, lactate) in non-hypoxemic COPD patients. METHODS Eleven non-depleted patients with COPD (FEV 1 65.5 ± 4.3 %) performed two EET (room-air or O 2 -Suppl-100 %), through a blind, randomized, and placebo-controlled crossover design. CPK, LDH and CRP were measured before, immediately after and 24 h after EET. RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3 %; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L). The O 2 -Suppl protocol resulted in a lower increase in CRP (92.1 ± 112.4 % vs. 400.1 ± 384.9 %; p = 0.003). CONCLUSIONS O 2 -Suppl increases exercise-tolerance, resulting in increased muscle injury markers in COPD. However, oxygen supplementation attenuates the inflammatory response, even upon increased physical exercise.",2020,"RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","['Eleven non-depleted patients with COPD (FEV 1 65.5\u2009±\u20094.3%) performed two EET (room-air or O 2 -Suppl-100', 'COPD patients', 'non-hypoxemic COPD patients']","['oxygen supplementation', 'Oxygen supplementation (O 2 -Suppl', 'O 2 -Suppl during exercise test (EET', 'Oxygen supplementation', 'placebo']","['Exercise time', 'CRP', 'CPK and LDH', 'CPK, LDH and CRP', 'total work and muscle damage markers', 'physical exercise', 'exercise-tolerance', 'CRP level and muscle damage (CPK, LDH, lactate', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",11.0,0.185322,"RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","[{'ForeName': 'Daniela Rodrigues', 'Initials': 'DR', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Kelly Critine', 'Initials': 'KC', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Julia Sampel', 'Initials': 'JS', 'LastName': 'de Castro', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Viviani Aparecida', 'Initials': 'VA', 'LastName': 'Lara', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'de Luca', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil.'}, {'ForeName': 'Mayron F', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; VO2Care Research Group, Research Physiotherapy Coordinator of Vila Nova Star Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Wladimir Musetti', 'Initials': 'WM', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil; Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil; Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; HEART - Institute of Cardiology, Department of Education and Research, São Paulo, Brazil. Electronic address: wmusettimedeiros@hotmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103475'] 1806,32512262,Intensive therapy alleviates subclinical synovitis on ultrasound and disease activity and reduces flare in rheumatoid arthritis patients who have achieved clinical target - a randomized controlled trial.,"OBJECTIVE Whether intensive therapy can alleviate subclinical synovitis and reduce flare in rheumatoid arthritis (RA) patients in clinical remission remains unclear. We designed a 1-year open-labelled, randomized controlled clinical trial to elucidate this question. METHODS RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2] were randomized to receive maintenance or intensive treatment at a ratio of 1:1. The primary outcome was the rate of RA relapse (defined by DAS28-CRP>3.2 and an increase≥0.6). The secondary outcomes were changes of PD and GS scores, and clinical disease activity at each visit from baseline. RESULTS 108 patients with 54 in each group were enrolled. During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively]. Although GS and PD scores were decreased at 12 months in both groups, the decline was more remarkable in intensive group than in maintenance group. The improvement of clinical disease activity score was only observed in intensive group, not maintenance group. Adverse events were comparable between two groups. Abnormal liver function tests were observed in 24 (22%) patients with 16 from intensive group. CONCLUSION Intensive therapy can alleviate subclinical synovitis on ultrasound and clinical disease activity, and prevent relapse in RA patients who have achieved clinical remission or low disease activity, with comparable safety profiles to maintenance therapy. REGISTRATION NUMBER ChiCTR2000029279.",2020,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","['rheumatoid arthritis patients who have achieved clinical target ', '24 (22%) patients with 16 from intensive group', 'RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2', '108 patients with 54 in each group were enrolled', 'rheumatoid arthritis']","['Intensive therapy', 'intensive therapy']","['rate of RA relapse', 'Adverse events', 'changes of PD and GS scores, and clinical disease activity', 'GS and PD scores', 'relapse rate', 'clinical disease activity score', 'Abnormal liver function tests']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}]",108.0,0.101084,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China. Electronic address: zhuoli.zhang@126.com.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.014'] 1807,32512785,Changes in Muscle Contractile Properties after Cold- or Warm-Water Immersion Using Tensiomyography: A Cross-Over Randomised Trial.,"Muscle contractile properties in clinical practice are often measured using either subjective scales or high-cost, inaccessible equipment. In this randomised cross-over study, we aimed to explore the use of tensiomyography (TMG) to assess changes in muscle contractile properties after cold- and warm-water immersion. The muscle contractile properties of the biceps femoris (BF) were assessed using TMG in 12 healthy active men (mean age 23 ± 3 years, Body Mass Index 22.9 ± 1.3 kg/m 2 ) before and after a 20-min warm- or cold-water immersion over a period of 40 min. Muscle displacement (Dm) and contraction time (Tc) were registered as the main variables of the study. There was a significant condition by time interaction for Dm ( p < 0.01). Post hoc analysis showed that, compared to the baseline, there was an increase in Dm 40 min after warm-water immersion ( p < 0.01) and a decrease at 10 min after cold-water immersion ( p < 0.01). No significant effect was found for Tc. Our results indicate that muscle contractile properties are affected by water temperature and time after the immersion; therefore, these factors should be taken into account when water-immersion is used as a recovery strategy.",2020,"Post hoc analysis showed that, compared to the baseline, there was an increase in Dm 40 min after warm-water immersion ( p < 0.01) and a decrease at 10 min after cold-water immersion ( p < 0.01).","['12 healthy active men (mean age 23 ± 3 years, Body Mass Index 22.9 ± 1.3 kg/m 2 ) before and after a 20-min warm- or cold-water immersion over a period of 40 min']","['tensiomyography (TMG', 'Cold- or Warm-Water Immersion Using Tensiomyography']","['Muscle displacement (Dm) and contraction time (Tc', 'Muscle Contractile Properties']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",12.0,0.0264037,"Post hoc analysis showed that, compared to the baseline, there was an increase in Dm 40 min after warm-water immersion ( p < 0.01) and a decrease at 10 min after cold-water immersion ( p < 0.01).","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mur Gimeno', 'Affiliation': 'School of Health Sciences, TecnoCampus, Pompeu Fabra University, 08302 Mataró, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Campa', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, 47921 Rimini, Italy.'}, {'ForeName': 'Georgian', 'Initials': 'G', 'LastName': 'Badicu', 'Affiliation': 'Department of Physical Education and Special Motricity, University Transilvania of Brasov, 500068 Brasov, Romania.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Castizo-Olier', 'Affiliation': 'School of Health Sciences, TecnoCampus, Pompeu Fabra University, 08302 Mataró, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Palomera-Fanegas', 'Affiliation': 'Unitat de Recerca i Bioestadística, Consorci Sanitari del Maresme, 08304 Mataró, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Sebio-Garcia', 'Affiliation': 'School of Health Sciences, TecnoCampus, Pompeu Fabra University, 08302 Mataró, Spain.'}]","Sensors (Basel, Switzerland)",['10.3390/s20113193'] 1808,32512930,The Development and Effectiveness of a Clinical Training Violence Prevention Program for Nursing Students.,"The study aimed to develop and evaluate a violence prevention program for nursing students to improve communication self-efficacy, problem-focused coping style, emotion-focused coping style, and the ability to cope with violence. Using an eight-session violence prevention program, the study was designed as quasi experimental, with a pretest, posttest, and follow-up assessment with a nonequivalent control group. Nursing students from the fourth year of a university were selected as participants; 22 students were assigned to the experimental group and 23 to the control group. Data analysis included Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA. Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77, p < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03, p < 0.001), and the ability to cope with violence (U = 70, p < 0.001) than the control group. Thus, the workplace violence prevention program was effective for nursing students.",2020,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77, p < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03, p < 0.001), and the ability to cope with violence (U = 70, p < 0.001) than the control group.","['Nursing students from the fourth year of a university were selected as participants; 22 students', 'nursing students', 'Nursing Students']","['Clinical Training Violence Prevention Program', 'workplace violence prevention program', 'violence prevention program']","['coping style', ""Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA"", 'ability to cope with violence', 'intra-individual and interaction effects for the emotion-focused coping style']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658335', 'cui_str': 'Workplace Violence'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",22.0,0.0137831,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77, p < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03, p < 0.001), and the ability to cope with violence (U = 70, p < 0.001) than the control group.","[{'ForeName': 'Yunhwa', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'Department of Nursing and Kyongbuk Science College, Gyeongsangbuk-do 39913, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Keimyung University, Daegu 42601, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114004'] 1809,32513308,Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. TRIAL DESIGN This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. PARTICIPANTS Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA. INTERVENTION AND COMPARATOR The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. MAIN OUTCOMES The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period. RANDOMIZATION Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability. BLINDING (MASKING) The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5. TRIAL STATUS Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing. TRIAL REGISTRATION ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. ","['hospitalized patients with COVID-19', 'patients hospitalized with severe COVID-19 used a similar ordinal scale', 'severely ill adults with COVID-19', 'Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6', 'enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm', 'hospitalized adults with severe SARS-CoV-2 infection', 'Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so', 'Columbia University Irving Medical Center in New York, USA']","['lopinavir- ritonavir', 'possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO', 'human anti-SARS-CoV-2 convalescent plasma', 'anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform', 'anti-SARS-CoV-2 plasma versus one unit']","['efficacy and safety', 'time to clinical improvement', 'Death', 'cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021613', 'cui_str': 'Inspiratory reserve volume'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.269262,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. ","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberger', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04422-y'] 1810,32515067,Compassion-focused therapy for body weight shame: A mixed methods pilot trial.,"Individuals with bigger bodies (body mass index greater than 30) often experience body weight shame and are at increased risk for mental health vulnerabilities such as depression and anxiety. To date, there have been no studies specifically designed and pilot tested to help with body weight shame for individuals with bigger bodies that do not have a diagnosed clinical condition. The aim of current study is to investigate the initial feasibility of compassion-focused therapy (CFT) as a 12-session group intervention for the reduction in body weight shame for individuals with bigger bodies. The study used a mixed method repeated measure design, with both quantitative and qualitative measures, to assess the initial feasibility of the CFT group-based intervention. Participants (N = 5) attended a 12-session/2-h group CFT programme aimed to directly target body weight shame by cultivating compassion. Measurements were conducted at three time points (pre-, post- and 3-month follow-up intervention). Results indicated that CFT had a positive impact on reducing body weight shame, increasing compassion and improving health-engaging behaviours. Qualitative feedback indicated the importance of the group dynamics to help with the de-shaming of body appearance for individuals. Results from this feasibility trial are promising, and future research using randomized controlled trial methodologies should be conducted to evaluate the effectiveness of CFT as a treatment option for body weight shame for individuals with bigger bodies.",2020,"Results indicated that CFT had a positive impact on reducing body weight shame, increasing compassion, and improving health engaging behaviors.","['Individuals with bigger bodies (Body Mass Index > 30) often experience body weight shame', 'individuals with bigger bodies', 'Body Weight Shame']","['CFT', 'Compassion Focused Therapy (CFT', '12-session/2-hour group CFT program']","['body weight shame', 'body weight shame, increasing compassion, and improving health engaging behaviors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036938', 'cui_str': 'Shame'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0357485,"Results indicated that CFT had a positive impact on reducing body weight shame, increasing compassion, and improving health engaging behaviors.","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Carter', 'Affiliation': 'Compassionate Mind Research Group, School of Psychology, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gilbert', 'Affiliation': 'Psychology Department, Derby University, Derby, UK.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Kirby', 'Affiliation': 'Compassionate Mind Research Group, School of Psychology, The University of Queensland, Brisbane, Queensland, Australia.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2488'] 1811,30222051,Lolland-Falster Health Study: Study protocol for a household-based prospective cohort study.,"Introduction: Lolland-Falster consists of two islands in the southern part of Denmark where income is lower and life expectancy is shorter than in the general Danish population. It is a mixed rural-provincial area with approximately 100,000 inhabitants. The Lolland-Falster Health Study was initiated to gain knowledge on the determinants of health in this disadvantaged area. Methods: The study is a household-based prospective cohort study including people of all ages. The entire household of randomly selected inhabitants is allocated either to an invited group or to an uninvited, non-contacted control group. The data collection encompasses questionnaires, physical examination and biological samples, i.e. blood and urine for same-day analysis and biobank storage, and saliva and faeces also for biobank storage. The civil registration number links collected data for each individual, family and household, with information in Danish registers. The data collection started in February 2016 and is estimated to end by 2019 after the enrolment of 20,000 people. Analysis: A number of in-depth sub-studies are planned. Emphasis will be given to analysis of intra- and inter-family variations in health determinants, genetics, lifestyle and health status. Ethics: Region Zealand's Ethical Committee on Health Research (SJ-421) and the Danish Data Protection Agency (REG-24-2015) approved the study. Trial registration: Clinicaltrials.gov (NCT02482896). Strength and limitations of this study: The strength of this study is that Lolland-Falster Health Study is a useful scientific resource for investigating cross-sectional difference and time trends within and between individuals, families and households. LOFUS adds diversity to the previously collected Danish population studies in urbanized areas. The limitation is that data collection is expensive. Conclusions: LOFUS will contribute to the knowledge on health in disadvantaged, rural-provincial areas.",2020,Lolland-Falster consists of two islands in the southern part of Denmark where income is lower and life expectancy is shorter than in the general Danish population.,"['household-based prospective cohort study including people of all ages', 'Lolland-Falster Health Study']",['LOFUS'],[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],,0.0607072,Lolland-Falster consists of two islands in the southern part of Denmark where income is lower and life expectancy is shorter than in the general Danish population.,"[{'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Jepsen', 'Affiliation': 'Lolland-Falster Health Study, Nykøbing Falster Hospital, Nykøbing F., Denmark.'}, {'ForeName': 'Cecilie Lindström', 'Initials': 'CL', 'LastName': 'Egholm', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'Centre of Research and Education in General Practice, Department of Public Health, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Simonsen', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Grarup', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Cyron', 'Affiliation': 'Medical Department, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ellervik', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Rasmussen', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}]",Scandinavian journal of public health,['10.1177/1403494818799613'] 1812,32521284,The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study.,"BACKGROUND The purpose of this study was to evaluate the effect of low-frequency self-administered vibration therapy into myofascial trigger points in the upper trapezius and levator scapulae on patients with chronic non-specific neck pain. METHODS Twenty-eight patients with chronic non-specific neck pain were randomly assigned into a vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention. Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold were assessed at baseline and after the first, fifth and 10th treatment sessions. FINDINGS Significant differences were found in the vibration group when compared to the control group after the treatment period: the vibration group reached lower Neck Disability Index scores (F = 4.74, P = .033, η 2  = 0.07) and greater pressure pain threshold values (F = 7.56, P = .01, η 2  = 0.10) than the control group. The vibration group reported a significant reduction in Neck Disability Index scores (χ2 = 19,35, P = .00, Kendall's W = 0.28) and an increase in pressure pain threshold (χ2 = 87,10, P = .00, Kendall's W = 0.73) between the assessment times over the course of the treatment. The mean increase in pressure pain threshold in the vibration group after the 10 sessions was 8.54 N/cm2, while the mean reduction in Neck Disability Index scores was 4.53 points. INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain. This tool could be recommended for people with non-specific neck pain.",2020,"INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","['people with non-specific neck pain', 'patients with chronic non-specific neck pain', 'Twenty-eight patients with chronic non-specific neck pain']","['low-frequency self-administered vibration therapy', 'vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention', 'vibration therapy']","['Neck Disability Index scores', 'Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold', 'pressure pain threshold', 'neck myofascial trigger points', 'pressure pain threshold values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224368', 'cui_str': 'Structure of levator scapulae muscle'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0224475,"INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dueñas', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: lirios.duenas@uv.es.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'European Sleep Care Institute, San Vicente 16, 46023, Valencia, Spain. Electronic address: innovation@escinstitute.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain; ""Pain in Motion"" international research group, Belgium. Electronic address: enrique.lluch@uv.es.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Artacho-Ramírez', 'Affiliation': 'Department of Engineering Projects, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: miarra@dpi.upv.es.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mayoral', 'Affiliation': 'Physical Therapy Unit, Hospital Provincial de Toledo, Toledo, Spain. Electronic address: orlando.mayoral@uclm.es.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Balasch', 'Affiliation': 'Departamento de Estadística e Investigación Operativa Aplicadas y Calidad, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: sbalasch@eio.upv.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balasch-Bernat', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: merce.balasch@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105071'] 1813,32521299,Efficacy of buffered hypertonic seawater in different phenotypes of chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery: a randomized double-blind study.,"PURPOSE Nasal douching is commonly used as a postoperative management strategy for chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies to date have compared the effectiveness of nasal douching in CRSwNP phenotypes after endoscopic sinus surgery (ESS). We evaluated the efficacy of seawater types in eosinophilic CRSwNP (ECRSwNP) and noneosinophilic CRSwNP (nonECRSwNP) after ESS. METHODS Patients with bilateral CRSwNP who had undergone ESS were blindly randomized to receive buffered hypertonic seawater (BHS) (n = 48) or physiological seawater (PS) (n = 45). CRSwNP patients were stratified by phenotypes (ECRSwNP and nonECRSwNP) retrospectively according to whether tissue eosinophils exceeded 10%. Follow-up evaluations were conducted at 2, 8, 16, and 24 weeks after surgery. Evaluations included the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events. RESULTS All of the patients experienced significant improvements in SNOT-22 scores, VAS scores, and LKES over time. BHS resulted in better improvement of LEKS and SCT relative to PS at 8 weeks postoperatively. Mucosal edema formation was significantly reduced with less crusting among HBS recipients at 8 weeks. After stratification, only patients in the nonECRSwNP + BHS subgroup showed a significant improvement in LEKS and SCT at 8 weeks postoperatively. Side effect profiles were not significantly different among the groups. CONCLUSIONS BHS has a better inhibitory effect on mucosal edema and crusting during the early postoperative care period of CRSwNP. Among all of the patients, nonECRSwNP patients showed a significant improvement in LEKS and SCT at 8 weeks.",2020,"Side effect profiles were not significantly different among the groups. ","['chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery', 'Patients with bilateral CRSwNP who had undergone ESS', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['buffered hypertonic seawater (BHS) (n\xa0=\xa048) or physiological seawater (PS) ', 'nonECRSwNP + BHS', 'noneosinophilic CRSwNP (nonECRSwNP', 'BHS', 'buffered hypertonic seawater']","['Mucosal edema formation', '22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events', 'mucosal edema and crusting', 'LEKS and SCT relative to PS', 'LEKS and SCT', 'SNOT-22 scores, VAS scores, and LKES over time']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0772097,"Side effect profiles were not significantly different among the groups. ","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Zhi-Qun', 'Initials': 'ZQ', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Meng-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jun-Hao', 'Initials': 'JH', 'LastName': 'Tu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China. Electronic address: yjholly@email.ncu.edu.cn.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102554'] 1814,32522090,Decision Regret among Informal Caregivers Making Housing Decisions for Older Adults with Cognitive Impairment: A Cross-sectional Analysis.,"Background . Informal caregivers are regularly faced with difficult housing decisions for older adults with cognitive impairment. They often regret the decision they made. We aimed to identify factors associated with decision regret among informal caregivers engaging in housing decisions for cognitively impaired older adults. Methods . We performed a secondary analysis of cross-sectional data collected from a cluster-randomized trial. Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults. Decision regret was assessed after caregivers' enrollment in the study using the Decision Regret Scale (DRS), scored from 0 to 100. We used a conceptual framework of potential predictors of regret to identify independent variables. We performed multilevel analyses using a mixed linear model by estimating fixed effects (β) and 95% confidence intervals (CIs). Results . The mean (SD) DRS score of 296 informal caregivers (mean [SD] age, 62 [12] years) was 12.4 (18.4). Factors associated with less decision regret were having a college degree compared to primary education (β [95% CI]: -11.14 [-18.36, -3.92]), being married compared to being single (-5.60 [-10.05, -1.15]), informal caregivers' perception that a joint process occurred (-0.14 [-0.25, -0.02]), and older adults' not having a specific housing preference compared to preferring to stay at home (-4.13 [-7.40, -0.86]). Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). Limitations . Our analysis may not illustrate all predictors of decision regret among informal caregivers. Conclusions . Our findings will allow risk-mitigation strategies for informal caregivers at risk of experiencing regret.",2020,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). ","['Older Adults with Cognitive Impairment', 'older adults with cognitive impairment', 'Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults', 'cognitively impaired older adults']",[],"['mean (SD) DRS score', 'decision regret', ""informal caregivers' perception that a joint process"", 'higher burden of care', 'Decision regret', 'higher decisional conflict', 'Decision Regret Scale (DRS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.118618,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). ","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Elidor', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ben Charif', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Codjo Djignefa', 'Initials': 'CD', 'LastName': 'Djade', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20925368'] 1815,32522251,"Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies.","BACKGROUND The interleukin-6 receptor inhibitor sarilumab demonstrated efficacy in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or as monotherapy in patients with moderately to severely active rheumatoid arthritis (RA) with an inadequate response (IR) or intolerant (INT) to methotrexate (MTX) or tumour necrosis factor (TNF)-α inhibitors. This analysis investigated the efficacy and safety of sarilumab in patient subgroups. METHODS Data were included from phase III studies: two placebo-controlled studies of subcutaneous sarilumab 150/200 mg every 2 weeks (q2w) either + MTX in MTX-IR patients (52 weeks) or + csDMARDs in TNF-IR/INT patients (24 weeks), and a monotherapy study of sarilumab 200 mg q2w vs. adalimumab 40 mg q2w in MTX-IR/INT patients (24 weeks). Prespecified and post hoc subgroups included patient demographics, disease characteristics, and prior treatments. Prespecified and post hoc endpoints included clinical, radiographic, and physical function measures, and p values are considered nominal. Safety was assessed during double-blind treatment. RESULTS The superiority of sarilumab (either as monotherapy vs. adalimumab or in combination with csDMARDs vs. placebo + csDMARDs) across clinical endpoints was generally consistent across subgroups defined by patient demographics, disease characteristics, and prior treatments, demonstrating the benefit of sarilumab treatment for a wide range of patient types. Interaction p values of < 0.05 were consistently observed across studies only for baseline anti-cyclic citrullinated peptide antibody (ACPA) status for American College of Rheumatology 20% response, but not American College of Rheumatology 50% or 70% response. Adverse events and worsening laboratory parameters occurred more frequently in sarilumab-treated vs. placebo-treated patients and were more frequent in the small number of patients ≥ 65 years (n = 289) vs. patients < 65 years (n = 1819). Serious infections occurred in six patients aged ≥ 65 years receiving sarilumab, although the incidence of serious infections was generally higher in patients aged ≥ 65 years regardless of treatment. CONCLUSIONS Apart from ACPA status, there were no consistent signals indicating differential effects of sarilumab in any of the subpopulations assessed. Sarilumab demonstrated consistent efficacy and safety across a wide range of patients with RA. TRIAL REGISTRATION ClinicalTrials.gov NCT01061736, registered on February 03, 2010; ClinicalTrials.gov NCT01709578, registered on October 18, 2012; ClinicalTrials.gov NCT02332590, registered on January 07, 2015.",2020,"Apart from ACPA status, there were no consistent signals indicating differential effects of sarilumab in any of the subpopulations assessed.","['patient subgroups', 'patients with moderately to severely active rheumatoid arthritis (RA) with an inadequate response (IR) or intolerant (INT) to', 'Data were included from phase III studies: two', 'registered on February 03, 2010', 'subpopulations of patients with moderately to severely active rheumatoid arthritis', 'six patients aged ≥']","['subcutaneous sarilumab 150/200\u2009mg every 2\u2009weeks (q2w) either + MTX in MTX-IR patients (52\u2009weeks) or + csDMARDs in TNF-IR/INT', 'methotrexate (MTX) or tumour necrosis factor (TNF)-α inhibitors', 'sarilumab (either as monotherapy vs. adalimumab or in combination with csDMARDs vs. placebo', 'sarilumab 200\u2009mg q2w vs. adalimumab 40\u2009mg q2w in MTX-IR/INT', 'sarilumab in combination with csDMARDs or as monotherapy', 'placebo']","['Safety', 'Adverse events and worsening laboratory parameters', 'Efficacy and safety', 'incidence of serious infections', 'efficacy and safety', 'Serious infections', 'clinical, radiographic, and physical function measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1257890', 'cui_str': 'Group'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.386519,"Apart from ACPA status, there were no consistent signals indicating differential effects of sarilumab in any of the subpopulations assessed.","[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA. genovese@stanford.edu.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern and Metroplex Clinical Research Center, Dallas, TX, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Eun-Bong', 'Initials': 'EB', 'LastName': 'Lee', 'Affiliation': 'Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'van Hoogstraten', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'St John', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Mangan', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité-University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-020-02194-z'] 1816,32535342,Food intake is associated with verbal interactions between nursing home staff and residents with dementia: A secondary analysis of videotaped observations.,"BACKGROUND Nursing home residents with dementia commonly experience low food intake, leading to negative functional and nutritional consequences. While the importance of staff-resident (dyadic) interactions during mealtime is acknowledged, little research has examined the role of dyadic verbal interactions on food intake. OBJECTIVES This study aimed to examine the relationship between food intake and dyadic verbal interactions. METHODS This study was a secondary analysis of 110 videotaped observations of mealtime care interactions among 25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes. Staff positive utterances and resident positive and negative utterances (independent variables) and food intake (dependent variable) were coded from the videotaped observations using the Cue Utilization and Engagement in Dementia video coding scheme. A linear mixed model was fit to the data. The two-way interaction effects of food type and video duration with each independent variable as well as two-way interaction effects among the independent variables were tested. Covariates included in the model were the number of years staff worked as a caregiver, and resident age, gender, and eating function. RESULTS The model included three significant interaction effects involving verbal variables: the interaction effect of staff positive utterances with resident positive utterances (p=.030), the interaction effect of staff positive utterances with food type (p=.027), and the interaction effect of resident negative utterances with video duration (p=0.002). Increased number of intakes of liquid food per minute was associated with increased number of staff positive utterances per minute when residents did not make positive utterances. Decreased number of intakes of solid food per minute was associated with increased number of staff positive utterances per minute, especially when residents made between 0 and 3 positive utterances per minute. As the duration of the videos increased, the number of intakes per minute increased for residents who made one or more negative utterances and decreased for residents who made no negative utterances in the videos. The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics. CONCLUSION Intake was associated with dyadic verbal interactions, and such relationship was complex in that it was moderated by food type and video duration. Findings support the significant role of dyadic verbal interactions on intake, and inform the development of effective, tailored mealtime care interventions to promote intake.",2020,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics. ","['25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes', 'nursing home staff and residents with dementia']",[],"['number of intakes per minute', 'dyadic verbal interactions', 'Staff positive utterances and resident positive and negative utterances (independent variables) and food intake', 'number of staff positive utterances']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",110.0,0.0676015,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics. ","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA. Electronic address: wen-liu-1@uiowa.edu.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Perkhounkova', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'The University of Kansas, School of Nursing, Kansas City, KS, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Batchelor', 'Affiliation': 'George Washington University, School of Nursing, Washington, D.C., USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103654'] 1817,32535407,An investigation of the impact of social exclusion on attachment to possessions and saving behaviors.,"BACKGROUND AND OBJECTIVES Hoarding disorder (HD) is a debilitating mental illness characterized by extreme difficulty parting with possessions and clutter that can result in dangerous living conditions. One hypothesis about why individuals with HD save possessions is that they possess a pathological attachment to their belongings, which may serve to compensate for unfulfilling interpersonal relationships. However, there is a dearth of empirical work examining this. The current study examined the impact of an experimental manipulation of social exclusion on attachment to possessions and saving behaviors in a sample of individuals with elevated hoarding symptoms. METHODS Participants (n = 117) were selected for scoring above the non-clinical mean on a measure of hoarding symptoms. Participants were randomized to either be included or excluded in a game of Cyberball. They completed a behavioral discarding task and object attachment measure before and after completion of the game. RESULTS Study condition was unrelated to in vivo attachment to possessions and saving behaviors during the discarding task. However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task. LIMITATIONS Limitations include the use of a non-clinical and homogeneous sample. CONCLUSIONS Taken together, individuals prone to feelings of rejection may be at risk for developing HD as they may use possessions to cope with interpersonal stress. Results will be discussed in light of implications for theoretical models and potential treatment targets in HD.",2020,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task. ","['individuals with elevated hoarding symptoms', 'Participants (n\xa0=\xa0117']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],117.0,0.034374,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task. ","[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Mathes', 'Affiliation': 'Florida State University, United States.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, United States. Electronic address: schmidt@psy.fsu.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101588'] 1818,32535481,Efficacy and safety of Abelmoschus manihot for IgA nephropathy: A multicenter randomized clinical trial.,"RATIONALE AND OBJECTIVE IgA nephropathy (IgAN) is an important cause for end-stage renal disease worldwide. The treatment for IgAN remains challenging, and few randomized and controlled clinical trials have been conducted to evaluate new therapies. The present study assesses the efficacy and safety of Abelmoschus manihot (AM) in IgAN patients. STUDY DESIGN Randomized, non-inferiority, double-blind, double-dummy multicenter trial. SETTING AND PARTICIPANTS This trial was designed to recruit 1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate [eGFR] of ≥ 45 ml/min/1.73 m 2 ) across China. INTERVENTIONS The participants were randomized at 1:1 to AM (2.5 g for three times per day) or losartan potassium (100 mg per day) for 48 weeks. OUTCOMES The primary outcome was the change in 24-hour proteinuria from baseline to week 48. The secondary outcomes were the change in eGFR from baseline to week 48, and the incidents of endpoint events (proteinuria ≥ 3.5 g/24 h, doubling of serum creatinine, or receiving renal replacement treatment). RESULTS Among 1,470 randomized patients (mean age, 37.4 [SD, 10.6] years old; 777 [52.9%] were female; mean eGFR, 95.0 [SD, 24.3] mL/min/1.73 m 2 ; mean 24-hour proteinuria, 1.2 [SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P = 0.676). The mean difference in the change in 24-h proteinuria between these two groups was -23.32 mg (95% confident interval: -123.2 to 76.6, p = 0.647). The mean decline in eGFR was 0.41 ml/min/1.73 m 2 and 0.76 ml/min/1.73 m 2 in the AM and losartan potassium groups, respectively (p = 0.661). The mean difference in the change in eGFR between these two groups was -0.43 ml/min/1.73 m 2 (95% confident interval: -1.99 to 1.13, p = 0.589). The incidence of endpoint events was 8.6% in the AM group and 8.2% in the losartan group (p = 0.851). LIMITATIONS The results of the trial may not be generalized to IgAN patients with a proteinuria of > 3.0 g/d and an eGFR of < 45 ml/min/1.73 m 2 . The long-term benefits of AM in reducing the risk of progressive renal dysfunction remains unclear, based on this 48-week observation. CONCLUSION AM can be recommended as a promising treatment for IgAN patients.",2020,The mean difference in the change in eGFR between these two groups was -0.43,"['IgAN patients', '1,470 randomized patients (mean age, 37.4 [SD, 10.6] years old; 777 [52.9%] were female; mean eGFR, 95.0 [SD, 24.3] mL/min/1.73 m 2 ; mean 24-hour proteinuria, 1.2 [SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P\xa0=\xa00.676', 'IgA nephropathy', '1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate [eGFR] of ≥ 45 ml/min/1.73 m 2 ) across China']","['AM', 'Abelmoschus manihot (AM', 'losartan potassium', 'Abelmoschus manihot', 'losartan']","['change in 24-hour proteinuria', 'eGFR', '24-h proteinuria', 'Efficacy and safety', 'mean decline in eGFR', 'incidence of endpoint events', 'efficacy and safety', 'change in eGFR']","[{'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517741', 'cui_str': '37.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0949866', 'cui_str': 'Abelmoschus'}, {'cui': 'C0996896', 'cui_str': 'Manihot'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0949866', 'cui_str': 'Abelmoschus'}, {'cui': 'C0996896', 'cui_str': 'Manihot'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1470.0,0.162545,The mean difference in the change in eGFR between these two groups was -0.43,"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': ""Department of Nephrology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Da Ping Hospital of Third Military Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of TCM, Tianjin 300192, China.'}, {'ForeName': 'Jingai', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Nephrology, The First Hospital of Shanxi Medical University, Taiyuan 030024, China.'}, {'ForeName': 'Niansong', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The Six Affiliated Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China.'}, {'ForeName': 'Wenge', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Guangyan', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Heilongjiang Provincial Academy of Traditional Chinese Medicine, Heilongjiang, 150036, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, 430061, China.'}, {'ForeName': 'Qinkai', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Zhenjiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Shanxi Provincial People's Hospital, Xi'an, 710068, China.""}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China. Electronic address: xfssun@126.com.'}, {'ForeName': 'Xiangmei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China. Electronic address: xmchen301@126.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153231'] 1819,32536013,"Health-Related Quality of Life in MONARCH 3: Abemaciclib plus an Aromatase Inhibitor as Initial Therapy in HR+, HER2- Advanced Breast Cancer.","BACKGROUND MONARCH 3, a phase III trial (NCT02246621) of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC), previously demonstrated significantly improved progression-free survival in patients receiving abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI). This study evaluated patient-reported outcomes, including global health-related quality of life (HRQoL), functioning, and symptoms. METHODS Patients were randomly assigned 2:1 to receive abemaciclib (150 mg twice daily; n = 328) or placebo (n = 165), plus 1 mg anastrozole or 2.5 mg letrozole daily. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Breast Cancer-Specific Quality of Life Questionnaire HRQoL instruments were administered at baseline, every two cycles during cycles 2 through 19 (each cycle being 28 days), every three cycles thereafter, and once at a short-term posttherapy follow-up visit (approximately 30 days after discontinuation). Longitudinal mixed regression and Cox proportional hazards models evaluated postbaseline change and time to sustained deterioration (TTSD), respectively. RESULTS Baseline scores were similar between treatment arms. Although select scores statistically favored the placebo arm, global HRQoL, most symptoms, and functioning scales did not meet the threshold for clinically meaningful differences between treatment arms. Only diarrhea favored the placebo arm with statistically and clinically meaningful differences. There were no TTSD differences between treatment arms for global HRQoL, most symptoms (except diarrhea), or functioning. CONCLUSION Over a 2-year period, there were no clinically meaningful differences in global HRQoL, functioning, and most symptoms for patients receiving abemaciclib plus NSAI compared with NSAI alone. Only diarrhea favored the placebo arm, consistent with prior safety data, which has been shown to be manageable and reversible. Combined with clinical efficacy, results support treatment with abemaciclib plus NSAI for postmenopausal women with HR+, HER2- ABC. IMPLICATIONS FOR PRACTICE The addition of abemaciclib to a nonsteroidal aromatase inhibitor (NSAI) was not associated with a clinically meaningful detriment in patient-reported global health-related quality of life, functioning, and most symptoms in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Prior studies have also demonstrated clinical efficacy of abemaciclib plus NSAI compared with NSAI alone, including improved progression-free survival and objective response rate. These results also complement previously reported toxicity data, as measured by investigator-assessed adverse events. Taken together, these results support treatment with abemaciclib plus NSAI for postmenopausal women with HR+, HER2- ABC.",2020,", there were no clinically meaningful differences in global HRQoL, functioning, and most symptoms for patients receiving abemaciclib plus NSAI compared with NSAI alone.","['patients receiving abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI', 'postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC', 'MONARCH 3', 'postmenopausal women with HR+, HER2- ABC', 'Patients', 'HR+, HER2- Advanced Breast Cancer']","['anastrozole or 2.5 mg letrozole daily', 'abemaciclib', 'Abemaciclib Plus an Aromatase Inhibitor', 'nonsteroidal aromatase inhibitor (NSAI', 'abemaciclib plus NSAI', 'placebo']","['global health-related quality of life (HRQoL), functioning, and symptoms', 'diarrhea', 'progression-free survival and objective response rate', 'global HRQoL, most symptoms, and functioning scales', 'global HRQoL, most symptoms (except diarrhea), or functioning', 'toxicity data', 'Cancer Quality of Life Questionnaire Core 30 and Breast Cancer-Specific Quality of Life Questionnaire HRQoL instruments', 'global HRQoL, functioning, and most symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.301533,", there were no clinically meaningful differences in global HRQoL, functioning, and most symptoms for patients receiving abemaciclib plus NSAI compared with NSAI alone.","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Tokunaga', 'Affiliation': 'National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Gyeonggi-Do, Republic of South Korea.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Breast Center, Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Stoffregen', 'Affiliation': 'Eli Lilly & Co., Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shekarriz', 'Affiliation': 'Eli Lilly & Co., Bad Homburg, Germany.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Andre', 'Affiliation': 'Eli Lilly & Co., Paris, France.'}, {'ForeName': 'M Corona', 'Initials': 'MC', 'LastName': 'Gainford', 'Affiliation': 'Eli Lilly & Co., Indianapolis, Indiana, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly & Co., Indianapolis, Indiana, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Johnston', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}]",The oncologist,['10.1634/theoncologist.2020-0084'] 1820,32536680,Erratum for A Comparison of the Weight Loss Effect between a Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy.,,2020,,[],['Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy'],[],[],"[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0105694,,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Maekawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Niizawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.E002-20'] 1821,32537126,Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham.,"Background People with chronic low back pain (LBP) typically have increased pain sensitivity compared to healthy controls, however its unknown if pain sensitivity differs based on LBP trajectory at baseline or after manual therapy interventions. We aimed to compare baseline pressure pain threshold (PPT) and temporal summation (TS) between people without LBP, with episodic LBP, and with persistent LBP, and to compare changes over time in PPT and TS after a lumbar spinal manipulation or sham manipulation in those with LBP. Methods Participants were aged 18-59, with or without LBP. Those with LBP were categorised as having either episodic or persistent LBP. PPT and TS were tested at baseline. LBP participants then received a lumbar spinal manipulation or sham, after which PPT and TS were re-tested three times over 30 min. Generalised linear mixed models were used to analyse data. Results One hundred participants (49 female) were included and analysed. There were 20 non-LBP participants (mean age 31 yrs), 23 episodic LBP (mean age 35 yrs), and 57 persistent LBP (mean age 37 yrs). There were no significant differences in PPT or TS between groups at baseline. There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability. Changes in PPT and TS after the interventions did not differ between the two LBP groups. Discussion We found no differences between people with no LBP, episodic LBP, or persistent LBP in baseline PPT or TS. Changes in PPT and TS following a lumbar manual therapy intervention do not appear to differ between LBP trajectories. Trial registration The trial was prospectively registered with ANZCTR (ACTRN12617001094369).",2020,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","['people without LBP, with episodic LBP, and with persistent LBP', 'One hundred participants (49 female) were included and analysed', 'adults with episodic and persistent low back pain trajectories', '20 non-LBP participants (mean age 31\u2009yrs), 23 episodic LBP (mean age 35\u2009yrs), and 57 persistent LBP (mean age 37\u2009yrs', 'Methods\n\n\nParticipants were aged 18-59, with or without LBP', '\n\n\nPeople with chronic low back pain (LBP']","['LBP', 'lumbar spinal manipulation']","['PPT or TS', 'pain sensitivity', 'Pressure pain threshold and temporal summation', 'baseline pressure pain threshold (PPT) and temporal summation (TS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0443150', 'cui_str': 'Baseline pressure'}]",100.0,0.151039,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00326-5'] 1822,32528654,Learning to make informed health choices: Protocol for a pilot study in schools in Barcelona.,"Introduction: The Informed Health Choices (IHC) project has developed learning resources to teach primary school children (10 to 12-year-olds) to assess treatment claims and make informed health choices. The aim of our study is to explore both the students' and teachers' experience when using these resources in the context of Barcelona (Spain). Methods: During the 2019-2020 school year, we will conduct a pilot study with 4 th and 5 th -year primary school students (9 to 11-year-olds) from three schools in Barcelona. The intervention in the schools will include: 1) a workshop with the teachers, and 2) lessons to the students. The data collection will include: 1) assessment of the IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment by the students at the end of the lessons, and 6) assessment of the IHC resources by the teachers at the end of the lessons. We will use ad hoc questionnaires and guides to register the data. We will perform a quantitative and qualitative analysis of the data to explore understandability, desirability, suitability, usefulness, facilitators and barriers of the resources. The most relevant results will be discussed and some recommendations on how to use, how to adapt (if needed), and how to implement the IHC resources to this context will be agreed. The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use. Ethical considerations: The study protocol has obtained an approval exemption from the Ethics Committee of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain).",2019,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use. ","['schools in Barcelona', 'primary school children (10 to 12-year-olds', 'During the 2019-2020 school year, we will conduct a pilot study with 4 th and 5 th -year primary school students (9 to 11-year-olds) from three schools in Barcelona']","['IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment', 'Santa Creu']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0303023,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use. ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martínez García', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alonso-Coello', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Asso Ministral', 'Affiliation': 'Maternal and Child Health Service, General Subdirectorate of Health Promotion, Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ballesté-Delpierre', 'Affiliation': 'ISGlobal, Hospital Clínic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Canelo Aybar', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'de Britos', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández Rodríguez', 'Affiliation': 'Escola Sant Martí, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gallego Iborra', 'Affiliation': 'Andalusian Health Service, Malaga, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Leo Rosas', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Llaquet', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ena Pery', 'Initials': 'EP', 'LastName': 'Niño de Guzmán Quispe', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': 'Pérez-Gaxiola', 'Affiliation': 'Paediatric Hospital of Sinaloa, Sinaloa, Mexico.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Requeijo', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Salas-Gama', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Samsó Jofra', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Terres', 'Affiliation': 'Institut Escola Antaviana, Barcelona, Spain.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Urreta', 'Affiliation': 'Clinical Epidemiology and Research Unit, University Hospital of Donostia, Donostia, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}]",F1000Research,['10.12688/f1000research.21292.3'] 1823,32521132,Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria.,"BACKGROUND Up-regulation of hepatic delta-aminolevulinic acid synthase 1 (ALAS1), with resultant accumulation of delta-aminolevulinic acid (ALA) and porphobilinogen, is central to the pathogenesis of acute attacks and chronic symptoms in acute hepatic porphyria. Givosiran, an RNA interference therapy, inhibits ALAS1 expression. METHODS In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned symptomatic patients with acute hepatic porphyria to receive either subcutaneous givosiran (2.5 mg per kilogram of body weight) or placebo monthly for 6 months. The primary end point was the annualized rate of composite porphyria attacks among patients with acute intermittent porphyria, the most common subtype of acute hepatic porphyria. (Composite porphyria attacks resulted in hospitalization, an urgent health care visit, or intravenous administration of hemin at home.) Key secondary end points were levels of ALA and porphobilinogen and the annualized attack rate among patients with acute hepatic porphyria, along with hemin use and daily worst pain scores in patients with acute intermittent porphyria. RESULTS A total of 94 patients underwent randomization (48 in the givosiran group and 46 in the placebo group). Among the 89 patients with acute intermittent porphyria, the mean annualized attack rate was 3.2 in the givosiran group and 12.5 in the placebo group, representing a 74% lower rate in the givosiran group (P<0.001); the results were similar among the 94 patients with acute hepatic porphyria. Among the patients with acute intermittent porphyria, givosiran led to lower levels of urinary ALA and porphobilinogen, fewer days of hemin use, and better daily scores for pain than placebo. Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions. CONCLUSIONS Among patients with acute intermittent porphyria, those who received givosiran had a significantly lower rate of porphyria attacks and better results for multiple other disease manifestations than those who received placebo. The increased efficacy was accompanied by a higher frequency of hepatic and renal adverse events. (Funded by Alnylam Pharmaceuticals; ENVISION ClinicalTrials.gov number, NCT03338816.).",2020,"Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions. ","['acute hepatic porphyria', '94 patients underwent randomization (48 in the givosiran group and 46 in the placebo group', '94 patients with acute hepatic porphyria', '89 patients with acute intermittent porphyria', 'patients with acute hepatic porphyria', 'symptomatic patients with acute hepatic porphyria', 'patients with acute intermittent porphyria', 'Acute Intermittent Porphyria']","['givosiran', 'RNAi Therapeutic Givosiran', 'subcutaneous givosiran', 'placebo']","['serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions', 'mean annualized attack rate', 'urinary ALA and porphobilinogen', 'levels of ALA and porphobilinogen and the annualized attack rate', 'annualized rate of composite porphyria attacks', 'rate of porphyria attacks', 'frequency of hepatic and renal adverse events', 'hemin use and daily worst pain scores']","[{'cui': 'C0268328', 'cui_str': 'Porphobilinogen synthase deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4688584', 'cui_str': 'givosiran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162565', 'cui_str': 'Acute intermittent porphyria'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C4688584', 'cui_str': 'givosiran'}, {'cui': 'C4042855', 'cui_str': 'RNAi-Based Therapeutics'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0032704', 'cui_str': 'Porphobilinogen'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018988', 'cui_str': 'Hemin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",94.0,0.425709,"Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions. ","[{'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Sardh', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ventura', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Paula Aguilera', 'Initials': 'PA', 'LastName': 'Peiró', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rees', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stölzel', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'D Montgomery', 'Initials': 'DM', 'LastName': 'Bissell', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Bonkovsky', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Windyga', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Karl E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Silver', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Siobán B', 'Initials': 'SB', 'LastName': 'Keel', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jiaan-Der', 'Initials': 'JD', 'LastName': 'Wang', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Penelope E', 'Initials': 'PE', 'LastName': 'Stein', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Harper', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Vassiliou', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Janneke G', 'Initials': 'JG', 'LastName': 'Langendonk', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Raili', 'Initials': 'R', 'LastName': 'Kauppinen', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Minder', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Horie', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Penz', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Shangbin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Ko', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Vaishnaw', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jae B', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Simon', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gouya', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913147'] 1824,32529753,Reduction in Circulating Advanced Glycation End Products by Mediterranean Diet Is Associated with Increased Likelihood of Type 2 Diabetes Remission in Patients with Coronary Heart Disease: From the Cordioprev Study.,"SCOPE It is hypothesized that decreased advanced glycation end products (AGEs) levels could affect type 2 diabetes mellitus (T2DM) remission in newly diagnosed patients through the consumption of two healthy diets. METHODS AND RESULTS Patients from CORDIOPREV study, all with previous cardiovascular events, with T2DM at the beginning of the study are included. Patients are randomized to a Mediterranean or a low-fat diet for five years. No different diabetes remission rates are found among diets. Serum methylglioxal (MG) and carboximethyllysine (CML), levels dietary AGE, as well as gene expression of AGER1 and RAGE are measured. Serum MG decreases only after the consumption of the Mediterranean diet. Moreover, a COX regression analysis shows that each SD decrease in the MG, occurring after the Mediterranean diet, increases the probability of T2DM remission with HR:2.56(1.02-6.25) and p = 0.046 and each SD increase in disposition index at baseline increases the probability of remission with HR:1.94(1.32-2.87) and p = 0.001. CONCLUSIONS It is demonstrated that the reduction of serum AGEs levels and the modulation of its metabolism, occurring after the consumption of a Mediterranean diet, might be involved in the molecular mechanism underlying the T2DM remission of newly diagnosed patients with coronary heart disease.",2020,We found no different diabetes remission rates among diets.,"['patients from CORDIOPREV study, all with previous cardiovascular event, diagnosed with T2DM at the beginning of the study with no glucose-lowering treatment', 'newly-diagnosed patients with coronary heart disease', 'Patients with Coronary Heart Disease']",['Mediterranean or a low-fat diet'],"['serum levels of Methylglioxal (MG) and CarboximethylLysine (CML), dietary AGE, as well as gene expression of AGER1 and RAGE', 'probability of T2DM remission', 'T2DM remission', 'diabetes remission rates', 'advanced glycation end products (AGEs) levels', 'disposition index', 'Serum MG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0440039,We found no different diabetes remission rates among diets.,"[{'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Gutierrez-Mariscal', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Magdalena P', 'Initials': 'MP', 'LastName': 'Cardelo', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'de la Cruz', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Alcala-Diaz', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Roncero-Ramos', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Guler', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vals-Delgado', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'López-Moreno', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Raul M', 'Initials': 'RM', 'LastName': 'Luque', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Delgado-Lista', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Yubero-Serrano', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901290'] 1825,32529868,Effect of positive end-expiratory pressure on functional residual capacity in two experimental models of acute respiratory distress syndrome.,"OBJECTIVE Measurement of positive end-expiratory pressure (PEEP)-induced recruitment lung volume using passive spirometry is based on the assumption that the functional residual capacity (FRC) is not modified by the PEEP changes. We aimed to investigate the influence of PEEP on FRC in different models of acute respiratory distress syndrome (ARDS). METHODS A randomized crossover study was performed in 12 pigs. Pulmonary (n = 6) and extra-pulmonary (n = 6) ARDS models were established using an alveolar instillation of hydrochloric acid and a right atrium injection of oleic acid, respectively. Low (5 cmH 2 O) and high (15 cmH 2 O) PEEP were randomly applied in each animal. FRC and recruitment volume were determined using the nitrogen wash-in/wash-out technique and release maneuver. RESULTS FRC was not significantly different between the two PEEP levels in either pulmonary ARDS (299 ± 92 mL and 309 ± 130 mL at 5 and 15 cmH 2 O, respectively) or extra-pulmonary ARDS (305 ± 143 mL and 328 ± 197 mL at 5 and 15 cmH 2 O, respectively). The recruitment volume was not significantly different between the two models (pulmonary, 341 ± 100 mL; extra-pulmonary, 351 ± 170 mL). CONCLUSIONS PEEP did not influence FRC in either the pulmonary or extra-pulmonary ARDS pig model.",2020,"The recruitment volume was not significantly different between the two models (pulmonary, 341 ± 100 mL; extra-pulmonary, 351 ± 170 mL). ","['acute respiratory distress syndrome', '12 pigs', 'acute respiratory distress syndrome (ARDS']","['positive end-expiratory pressure (PEEP)-induced recruitment lung volume using passive spirometry', 'positive end-expiratory pressure', 'PEEP']",['FRC and recruitment volume'],"[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]","[{'cui': 'C0016815', 'cui_str': 'Functional residual capacity'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0793061,"The recruitment volume was not significantly different between the two models (pulmonary, 341 ± 100 mL; extra-pulmonary, 351 ± 170 mL). ","[{'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiu-Mei', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing-Ran', 'Initials': 'JR', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Cheng', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong-Liang', 'Initials': 'HL', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan-Lin', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Xin', 'Initials': 'JX', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520920426'] 1826,32530339,"The effect of multistrain synbiotic and vitamin D3 supplements on the severity of atopic dermatitis among infants under 1 year of age: a double-blind, randomized clinical trial study.","Background: Atopic dermatitis (AD) is the most common chronic and recurrent skin disease during infancy. Objective: This study was aimed at evaluating the effect of synbiotic and vitamin D3 supplements on the severity of AD among infants under 1 year of age. Methods: This double-blind, randomized clinical trial study was conducted on 81 subjects with AD in Sabzevar, Iran in 2018. Subjects were randomly assigned to three groups. Synbiotic group was administered a dose of five drops/day of synbiotic in addition to routine treatment. Vitamin D3 group was administered 1000 units (IU) of vitamin D3 daily in addition to routine treatment. Control group just received routine treatments. The severity of AD was evaluated using SCORing Atopic Dermatitis (SCORAD) at baseline and two months' follow-up. Results: The mean age of subjects was 4.87 ± 3.5 and 59.26% ( n  = 48) were male. The mean SCOARD scores were substantially decreased in the synbiotic ( b xy : -13.90, 95% CI, -20.99, -6.81; p  < .001) and vitamin D3 ( b xy : -12.38, 95% CI, -19.33, -5.43; p  = .001) groups as compared to control one by the end of two months. Conclusions: Findings suggest that multistrain synbiotic and vitamin D3 supplements administration along with routine treatments, as complementary therapies, may be effective in reducing the severity of AD in infants.",2020,"The mean SCOARD scores was substantially decreased in the synbiotic (b xy : -13.90, 95% CI, -20.99, -6.81; P  < 0.001) and vitamin D3 (b xy :","['81 subjects with AD in Sabzevar, Iran in 2018', 'infants under 1 year of age', 'The mean age of subjects was 4.87\u2009±\u20093.5 and 59.26% (n\u2009=\u200948) were male']","['synbiotic and vitamin D3 supplements', 'multistrain synbiotic and vitamin D3 supplements', 'Vitamin D3', 'Synbiotic', 'vitamin D3']","['vitamin D3', 'severity of atopic dermatitis', 'mean SCOARD scores', 'SCORing Atopic Dermatitis (SCORAD']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",81.0,0.310092,"The mean SCOARD scores was substantially decreased in the synbiotic (b xy : -13.90, 95% CI, -20.99, -6.81; P  < 0.001) and vitamin D3 (b xy :","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Aldaghi', 'Affiliation': 'Department of Paediatric, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Human', 'Initials': 'H', 'LastName': 'Tehrani', 'Affiliation': 'Department of Paediatric, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': 'Department of Dermatology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Fatemeh Sham', 'Initials': 'FS', 'LastName': 'Abadi', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1782319'] 1827,32470440,Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial.,"Evaluation of tolerability is increasingly relevant for patients with haematological malignancies treated with chronically administered therapies. Adverse events from these agents might affect the ability of patients to tolerate treatment over time. Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease. Modern approaches to the evaluation and reporting of toxicity that capture the tolerability of treatment to the patient are imperative. In this Viewpoint, we present a focused, pilot, and longitudinal Toxicity over Time analysis of adverse events from lenalidomide and lenalidomide with rituximab in patients with follicular lymphoma treated in the CALGB 50401 (Alliance; NCT00238238) trial to define the trajectory of adverse events and quantify the burden of continuous, low-grade events. Toxicity over Time analyses provided clinically relevant descriptions of neutropenia and fatigue trajectories caused by lenalidomide that were not identified by standard analysis of the maximum grade events defined by the Common Terminology Criteria for Adverse Events. Systematic, rigorous incorporation of patient-reported outcomes in clinical trials will be crucial to our understanding of the tolerability of chronically administered therapies in patients with haematological malignancies.",2020,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","['patients with follicular lymphoma treated in the CALGB 50401 (Alliance', 'patients with haematological malignancies', 'patients with haematological malignancies treated with chronically administered therapies', 'patients living with indolent disease']","['lenalidomide and lenalidomide with rituximab', 'lenalidomide']","['Toxicity', 'Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability', 'grade symptomatic toxicities', 'neutropenia and fatigue trajectories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",50401.0,0.043714,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Thanarajasingam', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Washington University School of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Novotny', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30067-3'] 1828,32525761,A prospective quasi-experimental controlled study evaluating the use of dynamic elastomeric fabric orthoses to manage common postpartum ailments during postnatal care.,"OBJECTIVE To evaluate the effectiveness of a postnatal dynamic elastomeric fabric orthoses to manage postpartum pain, improve functional capacity and enhance the quality of life arising from postnatal ailments immediately to an 8-week postpartum, compared with patients who did not wear dynamic elastomeric fabric orthoses. METHOD A total of 51 postpartum women were recruited (day 0 to 10 days post-delivery) from hospitals and community-based health clinics to participate in a prospective quasi-experimental controlled study using parallel groups without random allocation. The subgroup of the compression shorts group wore SRC recovery shorts and received standard postnatal care. The comparison group received standard postnatal care alone. Wear compliance was monitored throughout the study. Primary outcome measure, Numeric Pain Rating Scale, and secondary outcome measures, Roland Morris Disability Questionnaire, Pelvic Floor Impact Questionnaire-7, and Short Form (SF-36) were assessed fortnightly over 8 weeks for both groups. RESULTS The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)). However, there was insufficient evidence of a statistical difference in Numeric Pain Rating Scale score at 8 weeks when comparing the compression shorts group and comparison group (-1.17; 95%CI: (-2.35, -0.01), R 2 = .19, p  = .050). The compression shorts group met the wear compliance of the dynamic elastomeric fabric orthoses and reported an average wear of the dynamic elastomeric fabric orthoses as 9 out of 14 days for 11 h per day (SD 4.8 h) between the fortnightly timepoints. CONCLUSION The use of dynamic elastomeric fabric orthoses may be considered during postnatal care as a non-pharmacological therapeutic intervention to manage pain resulting from common postpartum ailments. While the dynamic elastomeric fabric orthoses was clinically well accepted by participants with high wearing compliance, future research with larger population samples are needed to enable statistical conclusions on the effectiveness of a dynamic elastomeric fabric orthoses in postnatal care to be made. REGISTRATION Trial registration was not required as per the Australian Government Department of Health, Therapeutic Goods Administration.",2020,"The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)).","['51 postpartum women were recruited (day 0 to 10 days post-delivery) from hospitals and community-based health clinics to participate in a prospective quasi-experimental controlled study using parallel groups without random allocation', 'patients who did not wear dynamic elastomeric fabric orthoses']","['95%CI', 'postnatal dynamic elastomeric fabric orthoses', 'dynamic elastomeric fabric orthoses', 'standard postnatal care alone']","['Numeric Pain Rating Scale, and secondary outcome measures, Roland Morris Disability Questionnaire, Pelvic Floor Impact Questionnaire-7, and Short Form (SF-36', 'Numeric Pain Rating Scale score', 'Wear compliance', 'mean (SD) Numeric Pain Rating Scale score']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}]","[{'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",51.0,0.0465939,"The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)).","[{'ForeName': 'Jaclyn Michele', 'Initials': 'JM', 'LastName': 'Szkwara', 'Affiliation': 'Physiotherapy Program, Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Milne', 'Affiliation': 'Physiotherapy Program, Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Rathbone', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}]","Women's health (London, England)",['10.1177/1745506520927196'] 1829,32526225,The effect of HF-rTMS over the left DLPFC on stress regulation as measured by cortisol and heart rate variability.,"The prefrontal cortex, and especially the Dorsolateral Prefrontal Cortex (DLPFC), plays an inhibitory role in the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis under stressful situations. Moreover, recent evidence suggests that a sustained DLPFC activation is associated with adaptive stress regulation in anticipation of a stressful event, leading to a reduced stress-induced amygdala response, and facilitating the confrontation with the stressor. However, studies using experimental manipulation of the activity of the DLPFC before a stressor are scarce, and more research is needed to understand the specific role of this brain area in the stress-induced physiological response. This pre-registered study investigated the effect on stress regulation of a single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session over the left DLPFC applied before the Trier Social Stress Test in 75 healthy young women (M = 21.05, SD = 2.60). Heart rate variability (HRV) and salivary cortisol were assessed throughout the experimental protocol. The active HF-rTMS and the sham group showed a similar cognitive appraisal of the stress task. No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments. Importantly, participants in the active HF-rTMS group showed a lower cortisol response to stress. The effect of left prefrontal HF-rTMS on the stress system provides further critical experimental evidence for the inhibitory role played by the DLPFC in the regulation of the HPA axis.",2020,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","['75 healthy young women (M\u202f=\u202f21.05, SD\u202f=\u202f2.60']","['single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session', 'HF-rTMS']","['HRV', 'cortisol response', 'Heart rate variability (HRV) and salivary cortisol']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",75.0,0.0262171,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","[{'ForeName': 'Matias M', 'Initials': 'MM', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: matias.pulopulos@ugent.be.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schmausser', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Baliyan', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Venero', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium; Department of Psychiatry, University Hospital Brussels (UZBrussel), Belgium; Department of Electrical Engineering, Eindhoven University of Technology, the Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104803'] 1830,32526634,"Randomised phase II study of panitumumab plus irinotecan versus cetuximab plus irinotecan in patients with KRAS wild-type metastatic colorectal cancer refractory to fluoropyrimidine, irinotecan and oxaliplatin (WJOG 6510G).","BACKGROUND Cetuximab has been shown to be clinically active when given in combination with irinotecan in patients with irinotecan-refractory metastatic colorectal cancer (mCRC). However, it has remained unclear whether panitumumab is effective when combined with irinotecan. We compared efficacies of both regimens in this randomised phase II study. PATIENTS AND METHODS Patients with wild-type KRAS exon 2 mCRC previously treated with fluorouracil-, oxaliplatin- and irinotecan-based chemotherapies were randomised (1:1) to either panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm). The primary end-point was progression-free survival (PFS). The planned sample size was 120, expecting a hazard ratio (HR) of 1.0 with non-inferiority margin of 1.3 (one-sided alpha error 0.2 and power 0.7). Major secondary end-points were overall survival (OS), response rate and safety. RESULTS From December 2011 to September 2014, 121 patients were enrolled, and 61 and 59 patients were randomised to the panitumumab and cetuximab arms, respectively (1 patient excluded). Most patients (97%) had received prior chemotherapies containing bevacizumab. The median PFS was 5.42 months in the panitumumab arm and 4.27 months in the cetuximab arm (HR = 0.64, 95% confidence interval [CI] = 0.44-0.94, P < 0.001 for non-inferiority, P = 0.058 for superiority), and median OS was 14.85 and 11.53 months (HR = 0.66, 95% CI = 0.44-1.00, P = 0.050 for superiority), respectively. The incidence of grade 3 or 4 hypomagnesaemia was higher in the panitumumab arm than that in the cetuximab arm (17% vs. 7%). CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.",2020,"CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","['patients with KRAS wild-type metastatic colorectal cancer refractory to', 'patients with irinotecan-refractory metastatic colorectal cancer (mCRC', 'From December 2011 to September 2014', 'patients with irinotecan-refractory mCRC', '121 patients were enrolled, and 61 and 59 patients', 'Patients with wild-type KRAS exon 2 mCRC previously treated with']","['panitumumab plus irinotecan versus cetuximab plus irinotecan', 'fluoropyrimidine, irinotecan\xa0and oxaliplatin (WJOG 6510G', 'panitumumab', 'panitumumab and cetuximab', 'panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm', 'irinotecan', 'bevacizumab', 'fluorouracil-, oxaliplatin-\xa0and irinotecan-based chemotherapies']","['median OS', 'incidence of grade 3 or 4 hypomagnesaemia', 'overall survival (OS), response rate\xa0and safety', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",121.0,0.220477,"CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: dsakai@cfs.med.osaka-u.ac.jp.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroetererological Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuda', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy, Tokyo Women's Medical University, Yachiyo Medical Center, Yachiyo, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hisateru', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kagawa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otsu', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Hozumi', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': 'Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Shigemi', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Medical Oncology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Clinical Oncology, Jichi Medical University Hospital, Tochigi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.014'] 1831,32526669,A CT-based deep learning model for predicting the nuclear grade of clear cell renal cell carcinoma.,"PURPOSE To investigate the effects of different methodologies on the performance of deep learning (DL) model for differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC). METHOD Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019 were assigned to training or internal test dataset, and external test dataset was acquired from The Cancer Genome Atlas-Kidney Renal Clear Cell Carcinoma (TCGA-KIRC) database. The effects of different methodologies on the performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL), were compared using repeated measures analysis of variance (ANOVA) and receiver operating characteristic (ROC) curve analysis. The performance of DL-model was evaluated through accuracy and ROC analyses with internal and external tests. RESULTS In this retrospective study, patients (n = 390) from one hospital were randomly assigned to training (n = 370) or internal test dataset (n = 20), and the other 20 patients from TCGA-KIRC database were assigned to external test dataset. IC, the attention level, MC, and TL had major effects on the performance of the DL-model. The DL-model based on the cropping of an image less than three times the tumor diameter, without attention, a simple model and the application of TL achieved the best performance in internal (ACC = 73.7 ± 11.6%, AUC = 0.82 ± 0.11) and external (ACC = 77.9 ± 6.2%, AUC = 0.81 ± 0.04) tests. CONCLUSIONS CT-based DL model can be conveniently applied for grading ccRCC with simple IC in routine clinical practice.",2020,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","['Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019', 'differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC', 'patients (n\u202f=\u202f390) from one hospital were randomly assigned to training (n\u202f=\u202f370) or internal test dataset (n\u202f=\u202f20), and the other 20 patients from TCGA-KIRC database']",['CT-based deep learning model'],"['performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0004170', 'cui_str': 'Bone structure of atlas'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4760635', 'cui_str': 'Transfer Learning'}]",,0.0253668,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Wansheng', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Enming', 'Initials': 'E', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China. Electronic address: cem2008@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109079'] 1832,32526688,Examining the effect of a brief psychoeducation intervention based on self-regulation model on sexual satisfaction for women with breast cancer: A randomized controlled trial.,"PURPOSE The main goal of this study was to investigate whether the Self-Regulation Model could improve sexual satisfaction for women diagnosed with breast cancer. METHODS Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran. Participants were randomly assigned to either an intervention group (n = 40) or a control group (n = 40). All participants were administered a demographic questionnaire and an Index of Sexual Satisfaction (ISS) pre-intervention, immediately post-intervention, and 1, 2, and 3 months following the intervention. The control group completed the assessments along the same time line as the intervention group. Women in the experimental group were provided three sessions of a psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies to improve their overall sexual satisfaction with sexual intercourse. Each intervention took between 60 and 90 min to administer. RESULTS The experimental and control group participants were well balanced in terms of demographic characteristics and sexual satisfaction scores before the intervention. The intervention group showed a positive increasing trend in the sexual satisfaction scores over time while the control group participants had a negative trend (p < 0.05). There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time. CONCLUSION Providing a psychoeducational based intervention provided an increase of sexual satisfaction during intercourse for women diagnosed with breast cancer. The psychoeducation based intervention provided an opportunity for participants to dispel common myths regarding their disease and obtain new strategies and skills to improve their sexual satisfaction from intercourse with their partners.",2019,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time. ","['women diagnosed with breast cancer', 'Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran', 'women with breast cancer']","['psychoeducational based intervention', 'Self-Regulation Model', 'psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies', 'psychoeducation intervention based on self-regulation model']","['demographic characteristics and sexual satisfaction scores', 'sexual satisfaction scores', 'sexual satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0482538,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time. ","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Frouzan', 'Initials': 'F', 'LastName': 'Olfati', 'Affiliation': 'Metabolic Diseases Research Center, School of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: folfati@qums.ac.ir.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Oveisi', 'Affiliation': 'Metabolic Disease Research Center, School of Medicine, Qazvin University of Medical Science, Qazvin, Iran. Electronic address: soveysi@qums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: nbahrami@qums.ac.ir.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Astrologo', 'Affiliation': 'Interpersonal Relationships & Development Laboratory, Centre for Research in Human Development, Department of Psychology, Concordia University, Montréal, QC, Canada. Electronic address: lisa.astrologo@live.ca.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, Singapore. Electronic address: yiong_huak_chan@nuhs.edu.sg.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101673'] 1833,32526832,"Effects of Particulate Matter Education on Self-Care Knowledge Regarding Air Pollution, Symptom Changes, and Indoor Air Quality among Patients with Chronic Obstructive Pulmonary Disease.","The burden of illness resulting from adverse environmental exposure is significant. Numerous studies have examined self-care behaviors among patients with chronic obstructive pulmonary disease (COPD), but seldom assess these behaviors in relation to air pollution. The study aims to examine the effects of particulate matter (PM) education on prevention and self-care knowledge regarding air pollution, symptom changes, and indoor PM concentration levels among patients with COPD. A longitudinal, quasi-experimental design using a generalized estimating equation examined the effectiveness of the education intervention. Participants were 63 patients with COPD, of whom only 25 received intervention. Levels of PM 2.5 and PM 10 decreased in the first-month follow-up in the experimental group. Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control. Regarding the COPD assessment test and physical domain scores, the experimental group exhibited a greater improvement in the first-month follow-up. Scores on the psychological domain significantly changed in the sixth-month follow-up. The PM education coordinated by nurses improved the health of participants, maintaining six-month effects. Further studies should evaluate the practice barriers and effects of health education on preventive self-care behaviors regarding indoor PM among patients with COPD.",2020,Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control.,"['Participants were 63 patients with COPD, of whom only 25 received intervention', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Particulate Matter Education', 'particulate matter (PM) education']","['psychological domain', 'Self-Care Knowledge Regarding Air Pollution, Symptom Changes, and Indoor Air Quality', 'COPD assessment test and physical domain scores', 'prevention and self-care knowledge regarding air pollution, symptom changes, and indoor PM concentration levels', 'Levels of PM 2.5 and PM 10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085760', 'cui_str': 'Indoor Air Quality'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3844011', 'cui_str': '2.5'}]",63.0,0.0204067,Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control.,"[{'ForeName': 'Su-Er', 'Initials': 'SE', 'LastName': 'Guo', 'Affiliation': 'Department of Nursing and Graduate Institute of Nursing, College of Nursing, Chang Gung University of Science and Technology (CGUST), Chiayi County 613016, Taiwan.'}, {'ForeName': 'Miao-Ching', 'Initials': 'MC', 'LastName': 'Chi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}, {'ForeName': 'Su-Lun', 'Initials': 'SL', 'LastName': 'Hwang', 'Affiliation': 'Department of Nursing and Graduate Institute of Nursing, College of Nursing, Chang Gung University of Science and Technology (CGUST), Chiayi County 613016, Taiwan.'}, {'ForeName': 'Chieh-Mo', 'Initials': 'CM', 'LastName': 'Lin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17114103'] 1834,32526849,Therapeutic Atmosphere in Psychotherapy Sessions.,"There is uncertainty concerning what the active ingredients in psychotherapy are. The First Experimental Study of Transference interpretations (FEST) was a randomized controlled trial of the effects of transference work (TW) in psychodynamic psychotherapy. Women with low quality of object relations (QOR) showed a large positive effect of transference work, while men with high QOR showed a slight negative effect. The present study aimed to expand the knowledge from the FEST by investigating the therapeutic atmosphere with Structural Analysis of Social Behavior (SASB). Two-way ANOVAs were conducted to investigate differences between SASB cluster scores between subgroups. The therapeutic atmosphere was characterized by Protect-Trust, Affirm-Disclose and Control-Submit. Multilevel modeling was used to assess the relationship between a therapist variable and outcomes for men and women. Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.",2020,"Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.","['Women with low quality of object relations (QOR', 'women with low QOR and men with high QOR', 'men and women']","['Transference interpretations (FEST', 'transference work (TW']","['therapeutic atmosphere', 'SASB cluster scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205864', 'cui_str': 'Object Relations'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0040678', 'cui_str': 'Transference'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0204514', 'cui_str': 'Structural analysis'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0323645,"Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.","[{'ForeName': 'Marte L', 'Initials': 'ML', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Gullestad Binder', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Hanne Sofie J', 'Initials': 'HSJ', 'LastName': 'Dahl', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Nikolai O', 'Initials': 'NO', 'LastName': 'Czajkowski', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Critchfield', 'Affiliation': 'Department of Graduate Psychology, James Madison University, Harrisonburg, VA 22807, USA.'}, {'ForeName': 'Per A', 'Initials': 'PA', 'LastName': 'Høglend', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Kirkeveien 166, 0450 Oslo, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ulberg', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Kirkeveien 166, 0450 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17114105'] 1835,32527167,"Impact of endometrioma surgery on ovarian reserve: a prospective, randomized, pilot study comparing stripping with CO 2 laser vaporization in patients with bilateral endometriomas.","OBJECTIVE To assess ovarian reserve through antral follicle count (AFC) and ovarian volume (OV) determination after decapsulation (stripping technique) or CO 2 laser vaporization in the surgical treatment of patients with bilateral ovarian endometriomas. METHODS This prospective, randomized, blinded, self-controlled pilot study was set in a tertiary university hospital between January 2017 and December 2017, and included consecutive patients with bilateral ovarian endometriomas ≥3 cm. The study was registered with ClinicalTrials.gov under the title 'Impact on ovarian reserve according to the type of ovarian endometrioma excision: laser versus conventional cystectomy'; NCT03826355. For each patient, the endometrioma on one side was randomly selected to undergo CO 2 laser vaporization and the contralateral endometrioma to undergo laparoscopic decapsulation. RESULTS A total of 16 patients were included. There were no statistically significant between-group differences in OV and AFC levels at baseline. At the 6-month follow-up, OV and AFC levels were significantly higher in the laser-treated group versus the stripping technique. CONCLUSION Lower OV and AFC levels following excisional surgery for endometrioma versus CO 2 laser vaporization suggest a higher impact on ovarian reserve after the stripping procedure.",2020,"At the 6-month follow-up, OV and AFC levels were significantly higher in the laser-treated group versus the stripping technique. ","['patients with bilateral endometriomas', 'A total of 16 patients were included', 'tertiary university hospital between January 2017 and December 2017, and included consecutive patients with bilateral ovarian endometriomas ≥3 cm', 'patients with bilateral ovarian endometriomas']","['endometrioma surgery', 'stripping with CO 2 laser vaporization', 'decapsulation (stripping technique) or CO 2 laser vaporization', 'ovarian endometrioma excision: laser versus conventional cystectomy', 'CO 2 laser vaporization and the contralateral endometrioma to undergo laparoscopic decapsulation']","['ovarian reserve through antral follicle count (AFC) and ovarian volume (OV) determination', 'OV and AFC levels', 'ovarian reserve', 'Lower OV and AFC levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",16.0,0.0433131,"At the 6-month follow-up, OV and AFC levels were significantly higher in the laser-treated group versus the stripping technique. ","[{'ForeName': 'Mariona', 'Initials': 'M', 'LastName': 'Rius', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Gracia', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ros', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'María-Ángeles', 'Initials': 'MÁ', 'LastName': 'Martínez-Zamora', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'deGuirior', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Quintas', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}]",The Journal of international medical research,['10.1177/0300060520927627'] 1836,32527389,Effects of Age and Acute Moderate Alcohol Consumption on Electrophysiological Indices of Attention.,"OBJECTIVE Despite increased attention to risks and benefits associated with moderate drinking lifestyles among aging adults, relatively few empirical studies focus on acute alcohol effects in older drinkers. Using electroencephalographic indices of early attention modulation (P1 and N1) and later stimulus processing (P3), we investigated whether acute alcohol consumption at socially relevant doses differentially influences neurocognitive performance in older, relative to younger, moderate drinkers. METHOD Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers were randomly assigned to receive one of three alcohol doses (placebo, .04 g/dl, or .065 g/dl target breath alcohol concentrations). Repeated-measures analysis of variance examined the effects of age, alcohol dose concentration, and their potential interaction on P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task. RESULTS Age-specific effects on P1 amplitudes varied by instruction set, with alcohol-associated decreases in amplitude among older drinkers in response to task-relevant stimuli and increases to irrelevant stimuli, F(2, 141) = 2.70, p = .07, η p 2 = .04. In contrast, N1 analyses demonstrated alcohol-related latency reductions among older, relative to younger, adults, F(2, 83) = 3.42, p = .04. Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) = 5.73, p < .01, η p 2 = .08. CONCLUSIONS Our results underscore the impact of acute moderate alcohol consumption on attentional functioning, highlighting age-dependent sensitivity in electrophysiological indices of early attentional processing. Given the import of attentional functioning to quality of life and increases in drinking among a rapidly expanding aging population, these findings have broad public health relevance.",2020,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","['older drinkers', 'older, relative to younger, moderate drinkers', 'Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers']","['early attention modulation (P1 and N1) and later stimulus processing (P3', 'alcohol doses (placebo, .04']",['P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337677', 'cui_str': 'Moderate drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",87.0,0.0715192,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","[{'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'University of Florida Center for Addiction Research & Education, Gainesville, Florida.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}]",Journal of studies on alcohol and drugs,[] 1837,32546247,"Health-related quality of life of children and their parents 2 years after critical illness: pre-planned follow-up of the PEPaNIC international, randomized, controlled trial.","BACKGROUND Pediatric intensive care unit (PICU) survivors are at risk for prolonged morbidities interfering with daily life. The current study examined parent-reported health-related quality of life (HRQoL) in former critically ill children and parents themselves and aimed to determine whether withholding parenteral nutrition (PN) in the first week of critical illness affected children's and parents' HRQoL 2 years later. METHODS Children who participated in the pediatric early versus late parenteral nutrition in critical illness (PEPaNIC) trial and who were testable 2 years later (n = 1158) were included. Their HRQoL outcomes were compared with 405 matched healthy controls. At PICU admission, children had been randomly assigned to early-PN or late-PN. In the early-PN group, PN was initiated within 24 h after PICU admission. In the late-PN group, PN was withheld for up to 1 week in the PICU. Parents completed the Infant Toddler Quality of Life Questionnaire (ITQOL; age 2-3 years) or the Child Health Questionnaire-Parent Form 50 (CHQ-PF50; age 4-18 years). Besides, they completed the Health Utility Index (HUI) and the Short Form Health Survey (SF-12) regarding their child's and their own HRQoL, respectively. RESULTS For the total age group of 786 post-PICU survivors, parents reported lower scores for almost all HRQoL scales compared to healthy children. Age-specifically, younger critically ill children (2.5 to 3 years old) scored worse for growth and development and older children (4-18 years old) scored worse for role functioning and mental health. Parents' own mental and physical HRQoL was comparable to that of healthy control parents. No HRQoL differences were found between children in the late-PN and those in the early-PN group. CONCLUSIONS Parent-reported HRQoL of children 2 years after critical illness was impaired compared with healthy controls. In relation to their child's HRQoL, parents reported impairments in emotions, personal time, and family activities; however, their own HRQoL was not impaired. Withholding PN in the first week during critical illness had no impact on longer-term HRQoL of the child. TRIAL REGISTRATION Clinical trials, NCT01536275. Registered 22 February 2012.",2020,"For the total age group of 786 post-PICU survivors, parents reported lower scores for almost all HRQoL scales compared to healthy children.","['younger critically ill children (2.5 to 3\u2009years old) scored worse for growth and development and older children (4-18\u2009years old) scored worse for role functioning and mental health', 'Pediatric intensive care unit (PICU) survivors', 'Children who participated in the pediatric early versus late parenteral nutrition in critical illness (PEPaNIC) trial and who were testable 2\u2009years later (n\u2009=\u20091158) were included']",['withholding parenteral nutrition (PN'],"['emotions, personal time, and family activities', 'Infant Toddler Quality of Life Questionnaire (ITQOL; age 2-3\u2009years) or the Child Health Questionnaire', 'HRQoL scales', 'Health Utility Index (HUI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",405.0,0.151047,"For the total age group of 786 post-PICU survivors, parents reported lower scores for almost all HRQoL scales compared to healthy children.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Hordijk', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands.""}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Verbruggen', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands.""}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Güiza', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Joosten', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands.""}, {'ForeName': 'Karolijn', 'Initials': 'K', 'LastName': 'Dulfer', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands. k.dulfer@erasmusmc.nl.""}]","Critical care (London, England)",['10.1186/s13054-020-03059-2'] 1838,32543980,"Intralesional cryotherapy versus cryotherapy spray for the treatment of recalcitrant plantar warts: a prospective, randomized study.","Background: Recalcitrant plantar warts are representing a therapeutic challenge. Intralesional cryotherapy (ILC) has emerged as a promising therapeutic option in recalcitrant plantar warts treatment. Objective : To compare the clinical efficacy, safety and tolerability of (ILC) versus Cryotherapy spray (Cryo-sp) for treatment of recalcitrant plantar warts. Methods: One hundred-thirty patients with recalcitrant plantar warts were assigned equally to two groups. Group A received ILC and group B treated with Cryo-SP. Both groups received one session at 2 weeks intervals until complete clearance or for a maximum of 5 sessions. The main outcome was complete clearance of warts guided by dermoscopy. Follow-up was carried out for 6 months after the treatment. Results: Complete clearance occurred in 80.3% in group A compared to 50.8% in group B with a highly significant difference between both groups ( p  < .001). The clearance rate was faster in group A (1.5 ± 0.40) than group B (4 ± 1.3) ( p  < .001). The adverse effects were mild in group A than group B ( p  < .001). The recurrence rate was 2% in group A versus 23.3% in group B ( p  < .007).patients satisfaction was higher in ILC ( p  < .001). Conclusion: Intralesional cryotherapy is more effective, requiring few sessions with a low recurrence rate than cryo-sp.",2020,The recurrence rate was 2% in group A versus 23.3% in group B (P < 0.007).patients satisfaction was higher in ILC (P < 0.001).,"['recalcitrant plantar warts', 'One hundred-thirty patients with recalcitrant plantar warts']","['Cryotherapy spray (Cryo-sp', 'Cryo-SP', 'Intralesional cryotherapy', 'Intralesional cryotherapy versus Cryotherapy spray', 'ILC', 'Intralesional cryotherapy (ILC']","['complete clearance of the warts guided by dermoscopy', 'Complete clearance', 'clinical efficacy, safety and tolerability', 'clearance rate', 'adverse effects', 'recurrence rate']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",130.0,0.0471096,The recurrence rate was 2% in group A versus 23.3% in group B (P < 0.007).patients satisfaction was higher in ILC (P < 0.001).,"[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Albalat', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Enayat', 'Initials': 'E', 'LastName': 'Attwa', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Howyda Mohamed', 'Initials': 'HM', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1782821'] 1839,32544572,"A 10-week yoga practice has no effect on cognition, but improves balance and motor learning by attenuating brain-derived neurotrophic factor levels in older adults.","Despite studies investigating the effect of yoga on cognitive and motor functioning in older adults, the effect on dual-task performance and motor learning and the specific mechanisms underlying the positive effect of yoga remain unclear. Thus, the aim of this study was to investigate the effects of yoga on cognition, balance under single- and dual-task conditions, and motor learning. The potential role of brain-derived neurotrophic factor (BDNF) in induced improvement was also explored. Participants aged 60-79 years were randomized to either a control group (n = 15) or a yoga group (n = 18) for a 10-week period. The yoga group received 90-min duration yoga classes two times per week. Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements were assessed. Yoga practice decreased (P < 0.05) the velocity vector of the center of pressure under single- and dual-task conditions, whereas no changes in cognitive performance were observed. Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group. Significant moderate relationships (P < 0.05) between changes in BDNF levels and functional improvements were observed. Thus, 10 weeks of yoga practice resulted in improved balance and learning in the speed-accuracy motor task that were mediated by increased BDNF levels, but had no impact on cognition in older adults.",2020,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","['Participants aged 60-79\u202fyears', 'older adults']","['brain-derived neurotrophic factor (BDNF', 'control group (n\u202f=\u202f15) or a yoga group']","['cognitive performance', 'Yoga practice', 'BDNF levels', 'shorter movement time', 'reaction and movement times during learning', 'velocity vector of the center of pressure under single- and dual-task conditions', 'Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements', 'balance and learning', 'cognition, balance under single- and dual-task conditions, and motor learning', 'BDNF levels and functional improvements', 'faster reaction time']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0174528,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","[{'ForeName': 'Agnė', 'Initials': 'A', 'LastName': 'Čekanauskaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania. Electronic address: agne.cekanauskaite@lsu.lt.'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kilikevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}]",Experimental gerontology,['10.1016/j.exger.2020.110998'] 1840,32544700,Time course of drug-related treatment-emergent adverse side effects of brivaracetam.,"OBJECTIVE Treatment-emergent adverse events (TEAEs) in clinical trials are typically reported for the full duration of the treatment period including titration and maintenance. Drug-related central nervous system (CNS) TEAEs are common with antiseizure medications (ASMs) and can affect drug tolerability. In this report, we test the hypothesis that drug-related CNS TEAEs have early onset and decrease with time. Unlike prior ASM clinical trials, a novel design was used for brivaracetam (BRV) without initial drug titration allowing assessment of habituation to TEAEs separate from dose titration. METHODS Data were pooled from three studies (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]) in adult patients (≥16 years of age) with focal seizures receiving BRV adjunctive therapy. This post hoc analysis reports data on the prevalence and incidence of all drug-related CNS TEAEs and all TEAEs over time in patients who received BRV doses of 50-200 mg/day (without titration) vs. placebo during a 12-week treatment period. RESULTS A total of 1262 patients received the following: placebo (n = 459), BRV 50 mg/day (n = 200), BRV 100 mg/day (n = 353), and BRV 200 mg/day (n = 250). Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence. CONCLUSIONS Drug-related CNS TEAEs occurred early and substantially habituated over several weeks. TEAEs of ASMs might be better represented by division into early and late phases to guide clinician monitoring and patient expectations.",2020,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence. ","['1262 patients', 'adult patients (≥16\u202fyears of age) with focal seizures receiving BRV adjunctive therapy']","['Drug-related central nervous system (CNS', 'brivaracetam', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],1262.0,0.10034,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence. ","[{'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium. Electronic address: cedric.laloyaux@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: teresa.gasalla@ucb.com.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Fishman', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: jfishman@its.jnj.com.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: melinda.martin@ucb.com.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA. Electronic address: kleinp@epilepsydc.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107212'] 1841,32544794,Acute aerobic exercise enhances pleasant compared to unpleasant visual scene processing.,"Although acute aerobic exercise benefits different aspects of emotional functioning, it is unclear how exercise influences the processing of emotional stimuli and which brain mechanisms support this relationship. We assessed the influence of acute aerobic exercise on valence biases (preferential processing of negative/positive pictures) by performing source reconstructions of participants' brain activity after they viewed emotional scenes. Twenty-four healthy participants (12 women) were tested in a randomized and counterbalanced design that consisted of three experimental protocols, each lasting 30 min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST). After each of the protocols, participants viewed negative and positive pictures, during which event-related magnetic fields were recorded. Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset. Brain activity in this cluster showed that a negativity bias at REST (negative > positive picture processing) diminished after the Low-Int condition (positive = negative) and even reversed to a positivity bias after the Mod-Int condition (positive > negative). Thus, acute aerobic exercise of low and moderate intensities induces a positivity bias which is reflected in early, automatic processes.",2020,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"['Twenty-four healthy participants (12 women', ""participants' brain activity after they viewed emotional scenes""]","['Acute aerobic exercise enhances pleasant', 'lasting 30\xa0min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST', 'acute aerobic exercise']","['valence processing of emotional scenes', 'Brain activity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",24.0,0.139816,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"[{'ForeName': 'Tomasz S', 'Initials': 'TS', 'LastName': 'Ligeza', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland. Electronic address: tomasz.ligeza@uj.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Wyczesany', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Institute for Sports Science, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Roesmann', 'Affiliation': 'Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany; Institute for Clinical Psychology, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Junghofer', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}]",Brain and cognition,['10.1016/j.bandc.2020.105595'] 1842,32531622,Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.,"BACKGROUND AND AIM Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries. METHODS AND MATERIALS In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS. RESULTS Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05). CONCLUSION Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.",2020,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"['78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled', 'middle ear']","['packing materials (Gelfoam and silastic sheets', 'cartilage tympanoplasty with silastic sheet versus Gelfoam packing', 'silastic sheet or gelfoam']","['Success', 'perforation area percentage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C1289829', 'cui_str': 'Packing material'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0074517', 'cui_str': 'Silastic'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",78.0,0.0554288,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"[{'ForeName': 'Mahtab Rabbani', 'Initials': 'MR', 'LastName': 'Anari', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Miratashi', 'Initials': 'AM', 'LastName': 'Yazdi', 'Affiliation': 'Surgery Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Kazemi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atie', 'Initials': 'A', 'LastName': 'Moghtadaie', 'Affiliation': 'Internal Medicine Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Farbod', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Emami', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hd_emami@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102588'] 1843,32532144,Process Evaluation of a Clustered Randomized Control Trial of a Comprehensive Intervention to Reduce the Risk of Cardiovascular Events in Primary Health Care in Rural China.,"BACKGROUND Cardiovascular disease (CVD) is a major public health challenge in China. This study aims to understand the processes of implementing a comprehensive intervention to reduce CVD events in areas of drug therapy, lifestyle changes, and adherence support in a clustered randomized controlled trial (cRCT). This trial consisted of 67 clusters spanning over 3 years in Zhejiang Province, China. METHOD A qualitative process evaluation was nested within the cRCT conducted in 9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm. RESULTS Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills. However, the awareness of patients remained limited, thus compromising their use of CVD preventive drugs and adoption of healthy lifestyles. Health system factors further constrained providers' and patients' responses to the intervention. Financial barrier was a major concern because of the low coverage of health insurance. Other barriers included limited doctor-patient trust and suboptimal staff motivation. CONCLUSION Our study suggests the feasibility of implementing a comprehensive CVD risk reduction strategy in China's rural primary care facilities. However, health system barriers need to be addressed to ensure the success and sustainability of the intervention.",2020,"RESULTS Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","['9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm', 'Primary Health Care in Rural China', '67 clusters spanning over 3 years in Zhejiang Province, China', ""China's rural primary care facilities""]","['comprehensive intervention', 'Comprehensive Intervention', 'comprehensive CVD risk reduction strategy']","['prescribing behaviour of family doctors and their patient communication skills', 'Risk of Cardiovascular Events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0934951,"RESULTS Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","[{'ForeName': 'Guanyang', 'Initials': 'G', 'LastName': 'Zou', 'Affiliation': 'School of Economics and Management, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of STDs Prevention and Control, Dermatology Hospital, Southern Medical University, Guangzhou 510091, China.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Zhitong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walley', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17114156'] 1844,32532356,Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II).,"OBJECTIVES To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19. TRIAL DESIGN This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial. PARTICIPANTS Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020. INCLUSION CRITERIA hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below: 1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the ""informed consent form"" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image. EXCLUSION CRITERIA Patients will be excluded from the study if they meet any of the following criteria. 1.Patients have received other experimental treatment for COVID-19 within the last 30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m 2 ) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening assessment;6.Pregnant or lactating women or women using estrogen contraception;7.Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;8.Other conditions that the researchers consider not suitable for participating in this clinical trial. INTERVENTION AND COMPARATOR There will be two study groups: experimental and control. Both will receive all necessary routine treatment for COVID-19. The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x10 7 human DPSCs in 30ml saline solution) on day 1, 4 and 7; The control group will receive an equal amount of saline (placebo) on the same days. Clinical and laboratory observations will be performed for analysis during a period of 28 days for each case since the commencement of the study. MAIN OUTCOMES 1. Primary outcome The primary outcome is Time To Clinical Improvement (TTCI). By definition, TTCI is the time (days) it takes to downgrade two levels from the following six ordered grades [(grade 1) discharge to (grade 6) death] in the clinical state of admission to the start of study treatments (hDPSCs or placebo). Six grades of ordered variables: GradeDescriptionGrade 1:Discharged of patient;Grade 2:Hospitalized without oxygen supplement;Grade 3:Hospitalized, oxygen supplement is required, but NIV / HFNC is not required;Grade 4:Hospitalized in intensive care unit, and NIV / HFNC treatment is required;Grade 5:Hospitalized in intensive care unit, requiring ECMO and/or IMV;Grade 6:Death. ABBREVIATIONS NIV, non-invasive mechanical ventilation; HFNC, high-flow nasal catheter; IMV, invasive mechanical ventilation. 2. Secondary outcomes 2.1 vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure). During the screening period, hospitalization every day (additional time points of D1, D4, D7 30min before injection, 2h ± 30min, 24h ± 30min after the injection) and follow-up period D90 ± 3 days. 2.2 Laboratory examinations: during the screening period, 30 minutes before D1, D4, D7 infusion, 2h ± 30min, 24h ± 30min after the end of infusion, D10, D14, D28 during hospitalization or discharge day and follow-up period D90 ± 3 days. 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate. 2.5 Inflammation indicators: hypersensitive C-reactive protein, serum amyloid (SAA); 2.6 Infectious disease testing: Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), Hepatitis C (Anti-HCV), AIDS (HIVcombin), syphilis (Anti-TP), cytomegalovirus CMV-IgM, cytomegalovirus CMV-IgG; only during the screening period and follow-up period D90 ± 3. 2.7 Immunological testing: Collect peripheral blood to detect the phenotype of T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil by using flow cytometry. Collect peripheral blood to detect the gene profile of mononuclear cells by using single-cell analyses. Collect peripheral blood serum to detect various immunoglobulin changes: IgA, IgG, IgM, total IgE; Collect peripheral blood serum to explore the changes of cytokines, Th1 cytokines (IL-1 β, IL-2, TNF-a, ITN-γ), Th2 cytokines (IL-4, IL-6, IL -10). 2.8 Pregnancy test: blood β-HCG, female subjects before menopause are examined during the screening period and follow-up period D90 ± 3. 2.9 Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge). RANDOMIZATION Block randomization method will be applied by computer to allocate the participants into experimental and control groups. The random ratio is 1:1. BLINDING (MASKING) Participants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations) will be blinded. Injections of cell suspension and saline will be coded in accordance with the patient's randomisation group. The blind strategy is kept by an investigator who does not deliver the medical care or assess primary outcome results. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) Twenty participants will be randomized to the experimental and control groups (10 per group). TRIAL STATUS Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020. Patients screening commenced on 16 th April and an estimated date of the recruitment of the final participants will be around end of July. . TRIAL REGISTRATION Registration: World Health Organization Trial Registry: ChiCTR2000031319; March 27,2020. ClinicalTrials.gov Identifier: NCT04336254; April 7, 2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below', 'Twenty participants', '2.3 Blood routine', 'Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020', '30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m 2 ) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening', '1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the ""informed consent form"" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min', 'Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020', '\n\n\nParticipants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations', '2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020', 'female subjects before menopause are examined during the screening period and follow-up period D90 ± 3. 2.9', 'patients with severe COVID-19']","['allogeneic human dental pulp stem cells', 'intravenous injection of dental pulp stem cells suspension (3.0x10 7 human DPSCs in 30ml saline solution', 'control group will receive an equal amount of saline (placebo', 'hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image', 'allogeneic human dental pulp stem cells (DPSCs', 'cell suspension and saline', 'placebo']","['Time To Clinical Improvement (TTCI', 'Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge', 'white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate', 'vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure', 'T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil', 'Safety and efficacy assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587111', 'cui_str': 'Before menopause'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0037786', 'cui_str': 'Specific gravity'}, {'cui': 'C0042052', 'cui_str': 'Urobilinogen'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0028792', 'cui_str': 'Occult blood screening'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}, {'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0443611', 'cui_str': 'Fat globule'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0201683', 'cui_str': 'Chemical method'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442737', 'cui_str': 'Not detected'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0857490', 'cui_str': 'Granulocyte count'}, {'cui': 'C0200641', 'cui_str': 'Basophil count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0427566', 'cui_str': 'Macrothrombocyte'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0008429', 'cui_str': 'Cholinesterase'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0003074', 'cui_str': 'Anion gap'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein (a)'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",20.0,0.369317,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Qingsong', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'Beijing SH Biotechnology Co., Ltd., Beijing, 100070, China.'}, {'ForeName': 'Chenliang', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zun-En', 'Initials': 'ZE', 'LastName': 'Xia', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yehenala', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Gangqiao', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Tianjin Fopcells Pharmaceutical Technology Co., Ltd, Tianjin, 300074, China.'}, {'ForeName': 'Chu-Tse', 'Initials': 'CT', 'LastName': 'Wu', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China. 139100026365@163.com.'}, {'ForeName': 'Songling', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Stomatology, Capital Medical University, Beijing, 100006, China. slwang@ccmu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Tianyou Hospital, Wuhan University of Science and Technology, Wuhan, 430064, Hubei, China. helen-1101@hotmail.com.'}]",Trials,['10.1186/s13063-020-04380-5'] 1845,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE). OBJECTIVE To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability. METHODS Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability. RESULTS Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed. CONCLUSIONS ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005'] 1846,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates. OBJECTIVE We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation. METHODS We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms. RESULTS Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013). CONCLUSIONS Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007'] 1847,32534361,Long-term effects of mindfulness-based cognitive therapy in patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy: Twelve-month follow-up of a randomized controlled trial.,"We examined the long-term efficacy of mindfulness-based cognitive therapy (MBCT) compared to a psychoeducation group as an active control condition in patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy. A total of 125 patients were included in a bicentric, interviewer-blind, randomized, and actively controlled trial and were assigned to either an MBCT group (n = 61) or a psychoeducation group (n = 64). Patients' demographic characteristics and the results from our previous assessments have already been reported (Külz et al., 2019). At the 12-month follow-up the completion rate was 80%. OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups. Exploratory analyses showed that a composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts differed between groups in the per-protocol analysis, with a stronger reduction in the MBCT group. At the 12-month follow-up, the two groups showed a similar reduction of symptoms. However, preliminary evidence indicates that MBCT has a superior effect on some aspects of OCD. This should be replicated in future studies.",2020,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","['patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy', 'patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy', 'A total of 125 patients']","['MBCT', 'mindfulness-based cognitive therapy', 'mindfulness-based cognitive therapy (MBCT']","['OCD symptoms', 'composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679048', 'cui_str': 'Obsessive thoughts'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",125.0,0.0493293,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany. Electronic address: barbara.cludius@psy.lmu.de.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Landmann', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rose', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Esslingen University of Applied Sciences; Flandernstraße 101, 73732 Esslingen am Neckar, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany;; Schoen Clinic Roseneck, Am Roseneck 6, 83209 Prien am Chiemsee, Germany; Clinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'Anne Katrin', 'Initials': 'AK', 'LastName': 'Külz', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}]",Psychiatry research,['10.1016/j.psychres.2020.113119'] 1848,32534369,Hydroxychloroquine/ chloroquine as a treatment choice or prophylaxis for Covid-19 at the primary care level in developing countries: A Primum non Nocere dilemma.,"The Food and Drug Administration (FDA) warned against the use of Hydroxychloroquine or chloroquine for Covid-19 outside of a hospital or a clinical trial setting due to the risk of QT interval prolongation, ventricular tachycardia and the increased risk of these complications when combined with some antibiotics such as azithromycin. Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients. Despite these warnings, in several developing countries the official guidelines for treatment of Covid-19 patients at the primary care level recommend Hydroxychloroquine and azithromycin, among other treatments, as the first-choice for mild symptomatic Covid-19 patients, asymptomatic contacts or for prophylaxis. In our opinion there is a primum non nocere dilemma during this Covid-19 pandemic. In order to solve this bioethical problem, we strongly recommend that a randomized controlled trial in a primary care setting be carried out as a matter of urgency in these areas of the world.",2020,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.",['COVID-19 hospitalized patients'],"['azithromycin', 'Hydroxychloroquine/ chloroquine', 'Hydroxychloroquine or chloroquine', 'Hydroxychloroquine and azithromycin']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0510268,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.","[{'ForeName': 'Marco T Medina', 'Initials': 'MTM', 'LastName': 'Chevalier', 'Affiliation': 'Faculty of Medical Sciences, National Autonomous University of Honduras, WFN Regional Director for Latin America, Tegucigalpa, Honduras. Electronic address: marcotmedina@yahoo.com.'}, {'ForeName': 'Sir Salvador', 'Initials': 'SS', 'LastName': 'Moncada', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Manchester, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116972'] 1849,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D. SUBJECTS/METHODS Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction. RESULTS After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). CONCLUSIONS Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). ","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). ","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571'] 1850,32539786,Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.,"BACKGROUND Surgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown. METHODS The Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery. RESULTS The study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46). CONCLUSIONS Observational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities. TRIAL REGISTRATION The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.",2020,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"['Adult patients who underwent elective colorectal surgery', 'six Dutch hospitals', '39 patients had been randomized to active OAP and 39 to']","['OAP', 'colorectal surgery using oral non-absorbable antimicrobial prophylaxis', 'preoperative OAP with tobramycin and colistin or placebo', 'Oral non-absorbable antibiotic prophylaxis (OAP', 'placebo']","['infectious and non-infectious complications', 'incidence of deep SSI or mortality', 'relative risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.768962,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Kluytmans-van den Bergh', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Vlaminckx', 'Affiliation': 'Department of Medical Microbiology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'de Smet', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Vos Tot Nederveen Cappel', 'Affiliation': 'Department of Surgery, Admiraal de Ruyter Hospital, Goes, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Verheijen', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van der Vorm', 'Affiliation': 'Department of Medical Microbiology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bathoorn', 'Affiliation': 'Department of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacobien', 'Initials': 'J', 'LastName': 'Veenemans', 'Affiliation': 'Department of Medical Microbiology, Admiraal de Ruyter Hospital, Goes, the Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Weersink', 'Affiliation': 'Department of Medical Microbiology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Vos', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Clinical Pharmacy, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Nikolakopoulos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kluytmans', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. jankluytmans@gmail.com.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00745-2'] 1851,32540277,High blood pressure responders show largest increase in heartbeat perception accuracy after post-learning stress following a cardiac interoceptive learning task.,"Mental disorders with physical symptoms, e.g. somatic symptom disorder, are characterized by altered interoceptive accuracy (IAc), which can be explained by individual differences in interoceptive learning (IL). We investigated if stress facilitates IL. Seventy-three healthy participants performed a heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT). After exposure to a socially-evaluated cold pressor stress test (SECPT; n = 48) or a control condition (n = 25), two more HCTs were performed (T2: 30 min after SECPT; T3: 24 h later). After the HBPT, all participants showed an increase in IAc. We separated the stress group into high vs. low systolic blood pressures (SBP) responders (n = 24 each), with high SBP responders showing the largest IAc increases. Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2. Our results indicate that post-learning autonomic stress response facilitates IL, whereas the HPA axis response may be less important for this effect.",2020,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","['Seventy-three healthy participants', 'Mental disorders with physical symptoms, e.g. somatic symptom disorder']","['heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT', 'SECPT']","['HPA axis response', 'IAc', 'systolic blood pressures (SBP) responders', 'heartbeat perception accuracy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}]","[{'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",73.0,0.014762,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schenk', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Jean T M', 'Initials': 'JTM', 'LastName': 'Fischbach', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Müller', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Division of Clinical Psychology, Department of Psychology, Johannes Gutenberg University of Mainz, Mainz, Germany.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Diest', 'Affiliation': 'Department of Health Psychology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg. Electronic address: andre.schulz@uni.lu.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107919'] 1852,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied. RESULTS Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt. CONCLUSIONS Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002'] 1853,32540584,The effect of injection volume on long-term outcomes of US-guided subacromial bursa injections.,"PURPOSE Limited data exist on the efficacy of high- compared to low-volume US-guided corticosteroid injections (CI) in the subacromial-subdeltoid (SA-SD) bursa. Our purpose was to compare the short- and long-term efficacy of low- and high-volume injections, by using a capacity reference of SA-SD bursa volume, as assessed on cadaveric specimens. METHOD Within two years, 136 patients (63 males, 73 females; mean age: 46.11 ± 10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included. Patients were randomly assigned to low-volume (1 mL triamcinolone acetonide/40 mg) or high-volume (1 mL triamcinolone acetonide/40 mg, 9 mL anaesthetic agents) groups (67 and 69 patients, respectively). Visual Analogue Scores (VAS) were recorded at baseline, 30 min, 3 weeks, 3 months, 6 months and 1 year post-treatment. Predictors of complete recovery (VAS ≤ 2) at 1 year were analysed with multivariate Cox regression analysis. SA-SD bursa cadaveric dissection in 10 specimens was performed for volume assessment. RESULTS Injection volume was the only predictor of complete pain resolution at 1 year. High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001). Mean VAS scores at baseline and subsequent time-points were 6, 2.6, 2.2, 2, 1.6 and 1 for the high-volume and 7.8, 7.3, 4.7, 3.2, 2.5 and 1.8 for the low-volume group, respectively (P < .001, at all time-points). Cadaveric measurements showed a minimum SA-SD bursa volume of approximately 6.9 mL. CONCLUSIONS High-compared to low-volume US-guided CI are superior for achieving early pain recovery.",2020,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","['136 patients (63 males, 73 females; mean age: 46.11\u202f±\u202f10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included']","['US-guided subacromial bursa injections', 'low-volume US-guided corticosteroid injections (CI', 'low- and high-volume injections', 'triamcinolone acetonide/40\u202fmg) or high-volume (1\u202fmL triamcinolone acetonide/40\u202fmg, 9\u202fmL anaesthetic agents']","['minimum SA-SD bursa volume', 'complete pain resolution', 'chances of early pain recovery', 'Visual Analogue Scores (VAS', 'Mean VAS scores']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}]","[{'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.107082,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","[{'ForeName': 'Michail E', 'Initials': 'ME', 'LastName': 'Klontzas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Advanced Hybrid Imaging Systems, Institute of Computer Science, Foundation for Research and Technology (FORTH), 100 N. Plastira str., Voutes, 70013, Heraklion, Crete, Greece.'}, {'ForeName': 'Evangelia E', 'Initials': 'EE', 'LastName': 'Vassalou', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, General Hospital of Sitia, Xserokamares, 72300, Sitia, Lasithi, Crete, Greece. Electronic address: vassalou.e@hotmail.com.'}, {'ForeName': 'Aristeidis H', 'Initials': 'AH', 'LastName': 'Zibis', 'Affiliation': 'University of Thessaly, Faculty of Medicine, Department of Anatomy Mezourlo Viopolis, 41222, Larissa, Greece.'}, {'ForeName': 'Apostolos H', 'Initials': 'AH', 'LastName': 'Karantanas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, Medical School, University of Crete, Voutes, 71110, Heraklion, Greece.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109113'] 1854,32540588,Deep transcranial magnetic stimulation for obsessive-compulsive disorder is efficacious even in patients who failed multiple medications and CBT.,"OCD is a chronic and disabling disease with a lifetime prevalence of 2%-3%. About 40-60% of these patients do not adequately respond to pharmacotherapy and CBT. Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals. Yet it is unclear whether patients who failed numerous medications and/or CBT can still benefit from dTMS. Here, we analyzed recent data from a double-blind multicenter dTMS study and found efficacy of this novel treatment even in OCD patient cohorts who previously failed to respond to multiple medications and CBT.",2020,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"['OCD patient cohorts who previously failed to respond to multiple medications and CBT', 'patients who failed multiple medications and CBT']","['OCD', 'Deep transcranial magnetic stimulation', 'Deep transcranial magnetic stimulation (dTMS']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0274375,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"[{'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Roth', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, TX, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Tendler', 'Affiliation': 'Advanced Mental Health Care, Inc., Palm Beach, FL, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2020.113179'] 1855,32540624,Effects of night-time bicycling visibility aids on vehicle passing distance.,"Bicycling at night is dangerous, with vehicle passing distances being a key concern, given that the main cause of night-time bicycling fatalities is from motorists hitting bicyclists from behind. However, little is known about vehicle passing distances at night or how they are affected by bicyclist visibility. This study assessed the impact of different bicyclist visibility configurations on vehicle passing distances at night-time. Fourteen licenced drivers with normal vision (age 24.2 ± 3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night. Each lap involved passing two bicyclists displaying one of four visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles). Participants were instructed to pass each bicyclist at a distance of 1-metre at a speed no greater than 50 km/hr, consistent with Queensland's Minimum Passing Distance rule. Participants completed eight laps, two for each configuration, in a randomised sequence. Passing distance was measured using a vehicle-mounted ultra-sonic sensor (ToughSonic14; Senix). Following each lap, participants rated the difficulty level in judging the 1-metre passing distance, as well as their estimated passing distance. Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other. There was also a significant effect of visibility configuration on difficulty rating (p = 0.035), with the Control rated as the most difficult, followed by Helmet, Handlebars and Leg Retro-reflectors. Overall, additional visibility aids resulted in wider vehicle passing distances, likely due to enhanced visual cues for drivers. The findings suggest that bicyclists should incorporate additional visibility aids to encourage safer passing distances of vehicles at night-time.",2020,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.",['Fourteen licenced drivers with normal vision (age 24.2\u202f±\u202f3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night'],"['visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles', 'night-time bicycling visibility aids']","['visibility configuration on difficulty rating', 'Leg Retro-reflectors']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.0635457,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.","[{'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Black', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia. Electronic address: aa.black@qut.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Duff', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ng', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Ussher', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wood', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105636'] 1856,32552850,Intense and unpredictable perturbations during gait training improve dynamic balance abilities in chronic hemiparetic individuals: a randomized controlled pilot trial.,"BACKGROUND Previous studies have assessed the effects of perturbation training on balance after stroke. However, the perturbations were either applied while standing or were small in amplitude during gait, which is not representative of the most common fall conditions. The perturbations were also combined with other challenges such as progressive increases in treadmill speed. OBJECTIVE To determine the benefit of treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training for dynamic balance and gait post-stroke. METHODS Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1 min were allocated to either an unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization. Nine training sessions were conducted over 3 weeks. NonPerturb participants only walked on the treadmill but were offered perturbation training after the control intervention. Pre- and post-training evaluations included balance and gait abilities, maximal knee strength, balance confidence and community integration. Six-week phone follow-ups were conducted for balance confidence and community integration. Satisfaction with perturbation training was also assessed. RESULTS With no baseline differences between groups (p > 0.075), perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group. Walking-only training in the NonPerturb group (n = 8, pre-crossing) mostly had no effect (p > .292, ES < .26), except on balance confidence (p = .063, ES = .46). The effects of the gait training were still present on balance confidence and community integration at follow-up. Satisfaction with the training program was high. CONCLUSION Intense and unpredictable gait perturbations have the potential to be an efficient component of training to improve balance abilities and community integration in individuals with chronic stroke. Retrospective registration: ClinicalTrials.gov. March 18th, 2020. Identifier: NCT04314830.",2020,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","['Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1\u2009min', 'chronic hemiparetic individuals', 'individuals with chronic stroke']","['gait training', 'treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training', 'unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization', 'perturbation training']","['balance and gait abilities, maximal knee strength, balance confidence and community integration', 'dynamic balance abilities', 'balance confidence', 'maximal strength', 'progressive increases in treadmill speed', 'balance confidence and community integration']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.0445433,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Esmaeili', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Juneau', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Joseph-Omer', 'Initials': 'JO', 'LastName': 'Dyer', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Lamontagne', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Kairy', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bouyer', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval and Center for Interdisciplinary Research in Rehabilitation and Social Integration, CIUSSS-CN, Quebec City, Canada.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Duclos', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada. cyril.duclos@umontreal.ca.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00707-0'] 1857,32552857,"The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial.","BACKGROUND Most individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC). The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality. Optimizing medications through deprescribing (the process of reducing or stopping the use of inappropriate medications or medications unlikely to be beneficial) may improve outcomes for MCC patients with dementia or MCI. METHODS With input from patients, family members, and clinicians, we developed and piloted a patient-centered, pragmatic intervention (OPTIMIZE) to educate and activate patients, family members, and primary care clinicians about deprescribing as part of optimal medication management for older adults with dementia or MCI and MCC. The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado. The intervention has two components: a patient/ family component focused on education and activation about the potential value of deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing. Primary outcomes are total number of chronic medications and total number of potentially inappropriate medications (PIMs). We estimate that approximately 2400 patients across 9 clinics will receive the intervention. A comparable number of patients from 9 other clinics will serve as wait-list controls. We have > 80% power to detect an average decrease of - 0.70 (< 1 medication). Secondary outcomes include the number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions. DISCUSSION The OPTIMIZE trial will examine whether a primary care-based, patient- and family-centered intervention educating patients, family members, and clinicians about deprescribing reduces numbers of chronic medications and PIMs for older adults with dementia or MCI and MCC. TRIAL REGISTRATION NCT03984396. Registered on 13 June 2019.",2020,"The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality.","['approximately 2400 patients across 9 clinics will receive the intervention', 'older adults with dementia or mild cognitive impairment and multiple chronic conditions', 'individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC', 'MCC patients with dementia or MCI', 'With input from patients, family members, and clinicians', 'The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado', 'older adults with dementia or MCI and MCC']","['primary care clinicians about deprescribing as part of optimal medication management', 'primary care-based deprescribing intervention']","['adverse drug events, cognitive changes, hospitalization, and mortality', 'number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions', 'total number of chronic medications and total number of potentially inappropriate medications (PIMs']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0361616,"The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality.","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Bayliss', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA. Elizabeth.Bayliss@kp.org.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Shetterly', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Drace', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norton', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Green', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA: Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Weffald', 'Affiliation': 'Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, Veterans Affairs Medical Center, Durham, NC, USA.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Sheehan', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'School of Public Health, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maiyani', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Du Vall', 'Affiliation': 'Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Boyd', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Trials,['10.1186/s13063-020-04482-0'] 1858,32553996,"The effects of a nurse-led lifestyle intervention program on cardiovascular risk, self-efficacy and health promoting behaviours among patients with metabolic syndrome: Randomized controlled trial.","BACKGROUND Metabolic syndrome is a cluster of cardio-metabolic risk factors and a major burden for public health due to its increasing prevalence and adverse effects on cardiovascular health. Lifestyle modification is the first-line intervention for metabolic syndrome management. However, adopting healthy behaviours is challenging among patients with metabolic syndrome. OBJECTIVE To examine the effects of a nurse-led lifestyle intervention program on cardiovascular risks, self-efficacy and the implementation of health promoting behaviours. DESIGN A two-armed randomized controlled trial. SETTINGS AND PARTICIPANTS A total of 173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China. METHODS The participants were randomly assigned to either attend the lifestyle interventions (n = 86) or receive usual care from the study hospital (n = 87). The lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40 min), one educational booklet and six telephone follow-ups (bi-weekly, 20-30 min per call) in three months. The Framingham 10-year risk score was calculated to measure the participants' cardiovascular risks at baseline and 3-month. The Self-rated Abilities for Health Practices and Health Promoting Lifestyle Profile II was employed to measure the self-efficacy and health promoting behaviours at baseline, 1-month, and 3-month. The generalized estimating equation model was employed to examine the effects of the lifestyle intervention program. RESULTS No difference was detected in the baseline characteristics between the two groups. Decreased cardiovascular risk was found in the lifestyle intervention group, but no significant group-by-time effect was detected. The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05). Significant improvements were also detected in all subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours at 3-month (all p < 0.05). CONCLUSIONS The nurse-led Health Promotion Model guided lifestyle intervention program effectively improved the self-efficacy and implementation of health promoting behaviours in patients with metabolic syndrome. We recommend that nurses apply lifestyle interventions in routine care for patients with metabolic syndrome. Tweetable abstract: The RCT revealed that nurse-led lifestyle intervention was effective to improve self-efficacy and healthy behaviours among 173 MetS patients.",2020,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","['173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China', 'patients with metabolic syndrome', '173 MetS patients']","['nurses apply lifestyle interventions', 'nurse-led lifestyle intervention program', 'lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40\xa0min), one educational booklet and six telephone follow-ups', 'lifestyle interventions (n\xa0=\xa086) or receive usual care from the study hospital', 'Tweetable abstract']","['cardiovascular risks, self-efficacy', 'cardiovascular risk', 'cardiovascular risk, self-efficacy and health promoting behaviours', 'subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours', 'self-efficacy and healthy behaviours', 'Framingham 10-year risk score', 'self-efficacy and implementation of health promoting behaviours', 'self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",173.0,0.0272669,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: zhengxujuan@szu.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Pingdu People's Hospital, Qingdao, China. Electronic address: yuhongbo.doc@163.com.""}, {'ForeName': 'Xichenhui', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qiuxichenhui@163.com.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. Electronic address: sychair@cuhk.edu.hk.'}, {'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong. Electronic address: eliza.wong@polyu.edu.hk.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qunwang@szu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103638'] 1859,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis. METHODS We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters. RESULTS swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots. CONCLUSIONS The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514'] 1860,32554183,The interactive effects of test-retest and methylphenidate administration on cognitive performance in youth with ADHD: A double-blind placebo-controlled crossover study.,"Studies have shown that Methylphenidate (MPH) affects cognitive performance on the neuropsychological tests and clinical symptoms of individuals diagnosed with attention deficit/hyperactivity disorder (ADHD). This study investigated the acute effects of MPH on neuropsychological tests to explore the interaction between MPH and test-retest effects. Twenty youths with ADHD were tested before and after MPH intake in a double-blind placebo-controlled crossover design and compared to twenty matched controls. Participants were tested on a range of standardized tasks including sustained attention to response, N-Back, and Word/Color Stroop. Identical tasks were administered twice each testing day, before and 1 hour after MPH/Placebo administration. Healthy controls were tested similarly with no intervention. Decreases in response time (RT) variability across tasks and in commission errors were found in ADHD after MPH. Conversely, a significant increase in RT variability and increase in omission errors were observed after the placebo. In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively. Test-retest reliability was higher in controls than ADHD. It is suggested that cognitive tests are sensitive objective measures for the assessment of responses to MPH in ADHD but are also affected by repetition and fatigue.",2020,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","['youth with ADHD', 'individuals diagnosed with attention deficit/hyperactivity disorder (ADHD', 'Twenty youths with ADHD']","['Methylphenidate (MPH', 'methylphenidate', 'placebo']","['cognitive performance', 'RT variability and omission errors', 'Test-retest reliability', 'sustained attention to response, N-Back, and Word/Color Stroop', 'RT variability', 'response time (RT) variability across tasks and in commission errors', 'omission errors', 'commission errors']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",20.0,0.196672,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","[{'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Horowitz', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: itaizen@gmail.com.""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Avirame', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Naim-Feil', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel; Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}, {'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Rubinson', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Moses', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Gothelf', 'Affiliation': ""Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Child and Adolescent Psychiatry Division, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Levit-Binnun', 'Affiliation': 'Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}]",Psychiatry research,['10.1016/j.psychres.2020.113056'] 1861,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds. RESULTS In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures. CONCLUSIONS This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113'] 1862,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts. MAIN OUTCOME MEASURES 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072). CONCLUSIONS As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008'] 1863,32554412,"The Effect of Continuing Education on Dental Hygienists' Knowledge, Attitudes, and Practices Regarding Human Papillomavirus Related Oropharyngeal Cancer.","Purpose: The purpose of this study was to investigate the effect a continuing education (CE) course had on dental hygienists' knowledge, attitudes, and practices regarding human papillomavirus (HPV) related oropharyngeal cancer (OPC). Methods: A two-group, experimental post-test only design was used for this study. Randomly selected, licensed dental hygienists in the state of Florida, were recruited by email and assigned to either an experimental or control group. An investigator designed, questionnaire was developed and tested for validity and reliability. The experimental group received a one-hour web-based CE course on HPV related OPC. Six weeks later, a post-test questionnaire was administered to the experimental and control groups via an online platform, Qualtrics®. Data were analyzed using descriptive statistics and analysis of variance (ANOVA). Results: Out of 302 dental hygienists who agreed to participate, 133 completed the study for a participation rate of 44.0%. The knowledge score for the experimental group was 72.6% while the control group scored 58.4%. Results demonstrated statistically significant differences between the groups in terms of knowledge (F=33.81, df=1, p =0.00) and attitudes (F=13.91, df=1, p =0.00). No differences were found in oral examination procedures; however, statistically significant differences (F=7.47, df=1, p =0.007) were noted for items related to HPV specific examination practices between the two groups. Conclusion: Additional research is needed to identify what specific types of educational interventions are effective in increasing the HPV-related OPC knowledge and practice behaviors of dental hygienists.",2020,"Results demonstrated statistically significant differences between the groups in terms of knowledge (F=33.81, df=1, p =0.00) and attitudes (F=13.91, df=1, p =0.00).","['Randomly selected, licensed dental hygienists in the state of Florida, were recruited by email and assigned to either an experimental or control group', '302 dental hygienists who agreed to participate']",['continuing education (CE'],"['knowledge score', 'knowledge', 'oral examination procedures', 'HPV specific examination practices']","[{'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0011369', 'cui_str': 'Dental hygienist'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013626', 'cui_str': 'Continuing Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376306', 'cui_str': 'Oral examination'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",302.0,0.0251556,"Results demonstrated statistically significant differences between the groups in terms of knowledge (F=33.81, df=1, p =0.00) and attitudes (F=13.91, df=1, p =0.00).","[{'ForeName': 'Toni M', 'Initials': 'TM', 'LastName': 'McLeroy', 'Affiliation': ''}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Gurenlian', 'Affiliation': ''}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Rogo', 'Affiliation': ''}]",Journal of dental hygiene : JDH,[] 1864,32554566,Use of an electronic decision support tool to reduce polypharmacy in elderly people with chronic diseases: cluster randomised controlled trial.,"OBJECTIVE To evaluate the effects of a computerised decision support tool for comprehensive drug review in elderly people with polypharmacy. DESIGN Pragmatic, multicentre, cluster randomised controlled trial. SETTING 359 general practices in Austria, Germany, Italy, and the United Kingdom. PARTICIPANTS 3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner. INTERVENTION A newly developed electronic decision support tool comprising a comprehensive drug review to support general practitioners in deprescribing potentially inappropriate and non-evidence based drugs. Doctors were randomly allocated to either the electronic decision support tool or to provide treatment as usual. MAIN OUTCOME MEASURES The primary outcome was the composite of unplanned hospital admission or death by 24 months. The key secondary outcome was reduction in the number of drugs. RESULTS 3904 adults were enrolled between January and October 2015. 181 practices and 1953 participants were assigned to electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group). The primary outcome (composite of unplanned hospital admission or death by 24 months) occurred in 871 (44.6%) participants in the intervention group and 944 (48.4%) in the control group. In an intention-to-treat analysis the odds ratio of the composite outcome was 0.88 (95% confidence interval 0.73 to 1.07; P=0.19, 997 of 1953 v 1055 of 1951). In an analysis restricted to participants attending practice according to protocol, a difference was found favouring the intervention (odds ratio 0.82, 95% confidence interval 0.68 to 0.98; 774 of 1682 v 873 of 1712, P=0.03). By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42 v 0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001). CONCLUSIONS In intention-to-treat analysis, a computerised decision support tool for comprehensive drug review of elderly people with polypharmacy showed no conclusive effects on the composite of unplanned hospital admission or death by 24 months. Nonetheless, a reduction in drugs was achieved without detriment to patient outcomes. TRIAL REGISTRATION Current Controlled Trials ISRCTN10137559.",2020,"By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42 v 0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001). ","['elderly people with polypharmacy', '3904 adults were enrolled between January and October 2015', '181 practices and 1953 participants', 'elderly people with chronic diseases', '359 general practices in Austria, Germany, Italy, and the United Kingdom', '3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner']","['electronic decision support tool', 'electronic decision support tool or to provide treatment as usual', 'computerised decision support tool', 'electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group']","['number of drugs', 'unplanned hospital admission or death by 24 months', 'composite of unplanned hospital admission or death by 24 months', 'number of prescribed drugs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",3904.0,0.221708,"By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42 v 0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001). ","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rieckert', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany Anja.Rieckert@uni-wh.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Altiner', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Drewelow', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Aneez', 'Initials': 'A', 'LastName': 'Esmail', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flamm', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hann', 'Affiliation': 'Centre for Biostatistics, School for Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Johansson', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Klaassen-Mielke', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, Ruhr-University Bochum, Germany.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kunnamo', 'Affiliation': 'Duodecim Medical Publications, Helsinki, Finland.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Löffler', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Piccoliori', 'Affiliation': 'Institute for General Practice of Bolzano, Bolzano, Italy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sommerauer', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany.'}, {'ForeName': 'Ulrike S', 'Initials': 'US', 'LastName': 'Trampisch', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vögele', 'Affiliation': 'Institute for Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Adrine', 'Initials': 'A', 'LastName': 'Woodham', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sönnichsen', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1822'] 1865,32554724,Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol.,"INTRODUCTION Technology is emerging as a solution to develop home-based, proactive 'real-time' symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities. METHODS AND ANALYSIS This study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS-Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians. ETHICS AND DISSEMINATION The study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03335189.",2020,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities. ","['114 patients will be recruited in oncology clinics prior to initiation of chemotherapy', 'patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre']",['remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can'],"['symptom severity, emotional distress, quality of life and acceptability', 'Feasibility metrics (recruitment, retention and protocol adherence']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",114.0,0.0743316,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities. ","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Moradian', 'Affiliation': 'School of Nursing, York University Faculty of Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Krzyzanowska', 'Affiliation': 'University of Toronto Institute of Health Policy Management and Evaluation, Toronto, Ontario, Canada.'}, {'ForeName': 'Roma', 'Initials': 'R', 'LastName': 'Maguire', 'Affiliation': 'University of Strathclyde Department of Computer and Information Sciences, Glasgow, UK.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kukreti', 'Affiliation': 'Division of Medical Oncology and Hematology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Amir', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Plinio P', 'Initials': 'PP', 'LastName': 'Morita', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University Health Network and Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Howell', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada doris.howell@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035648'] 1866,32554725,Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study.,"OBJECTIVES To design an electronic questionnaire for symptom monitoring and to evaluate the feasibility, usability and acceptability when applied to patients with metastatic lung cancer. SETTING Single-centre feasibility study. PARTICIPANTS Patients with stage IV lung cancer in antineoplastic treatment. INTERVENTIONS This study describes the first three phases of a complex intervention design: phase 1, development of the intervention; phase 2, feasibility testing and phase 3, evaluation of the intervention. In phase 1, items were selected for the questionnaire and adjusted following patient interviews. In phase 2, patients completed the electronic questionnaire weekly during a 3-week feasibility test. In case of symptom deterioration, a nurse was notified with the aim to contact the patient. In phase 3, patients evaluated phase 2 by paper questionnaires, and interviews were conducted with the participating nurses. PRIMARY OUTCOME MEASURES The study outcomes: phase 1, usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance. RESULTS In phase 1, a questionnaire was designed and reviewed by patients (n=8). The interviews revealed high usability and relevance of the intervention.For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis. Two patients did not complete any questionnaires (compliance 90%). The remaining 18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed). Reported symptoms led to a phone call from a nurse in 30% of the responses.The patients reported high usability and acceptability of questionnaire and software. The substance of the telephonic conversations was relevant, and the study set-up was logistically acceptable. CONCLUSIONS An electronic questionnaire designed for symptom monitoring revealed high usability, acceptability and relevance in the target population. In conclusion, the study set-up was considered feasible for a randomised controlled trial. TRIAL REGISTRATION NUMBER NCT03529851.",2020,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","['patients with metastatic lung cancer', 'Patients with stage IV lung cancer in antineoplastic treatment', '18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed']",['Electronic symptom monitoring'],"['usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance', 'feasibility, usability and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0855005', 'cui_str': 'Lung carcinoma cell type unspecified stage IV'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",29.0,0.0401048,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","[{'ForeName': 'Rasmus Blechingberg', 'Initials': 'RB', 'LastName': 'Friis', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark rasfri@rm.dk.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hjollund', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Caroline Trillingsgaard', 'Initials': 'CT', 'LastName': 'Mejdahl', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Halla', 'Initials': 'H', 'LastName': 'Skuladottir', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-035673'] 1867,32554735,Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea.,"INTRODUCTION The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy, which is known to have a high recurrence rate. Several factors might affect the outcome of anterior colporrhaphy, and the use of absorbable sutures might also be associated with the high recurrence rate because the sutures might not be able to retain adequate strength until the plicated pubocervical fascia remodels and regains maximum tensile strength. Nonetheless, no comparative data exist about the relative efficacy and safety of anterior colporrhaphy using non-absorbable versus absorbable sutures. The objective of this study is to compare the surgical outcomes of anterior colporrhaphy using non-absorbable sutures with those of anterior colporrhaphy using absorbable sutures. METHODS AND ANALYSIS This is a randomised, multicentre, superiority trial. Anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either non-absorbable or absorbable sutures. The primary outcome is composite surgical success 1 year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary. The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy. The planned number of participants is 192. ETHICS AND DISSEMINATION This study was approved by the Institutional Review Board of Seoul National University Hospital (H-1810-037-977). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings. TRIAL REGISTRATION NUMBER NCT03736811.",2020,"The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy.","['South Korea', 'Seoul National University Hospital (H-1810-037-977']","['absorbable versus absorbable sutures', 'anterior colporrhaphy using non-absorbable sutures', 'Anterior colporrhaphy', 'anterior colporrhaphy using absorbable sutures', 'anterior colporrhaphy using non-absorbable versus absorbable sutures', 'fibromuscular layer using either non-absorbable or absorbable sutures']","['composite surgical success 1\u2009year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary', 'individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy']","[{'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}]",,0.129302,"The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy.","[{'ForeName': 'Myung Jae', 'Initials': 'MJ', 'LastName': 'Jeon', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, The Republic of Korea jeonmj@snu.ac.kr.'}, {'ForeName': 'Dong Hoon', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, The Republic of Korea.'}, {'ForeName': 'Chul Hong', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Obstetrics and Gynecology, Chonnam National University Medical School, Gwangju, The Republic of Korea.'}, {'ForeName': 'Hyun-Hee', 'Initials': 'HH', 'LastName': 'Cho', 'Affiliation': ""Obstetrics and Gynecology, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, The Republic of Korea.""}, {'ForeName': 'Jung-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Obstetrics and Gynecology, Korea University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Sa Ra', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, The Republic of Korea.'}, {'ForeName': 'Yong Wook', 'Initials': 'YW', 'LastName': 'Jung', 'Affiliation': 'Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Soo Rim', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': ""Obstetrics and Gynecology, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, The Republic of Korea.""}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kong', 'Affiliation': ""Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, The Republic of Korea.""}]",BMJ open,['10.1136/bmjopen-2019-034218'] 1868,32554736,"Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial.","INTRODUCTION To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique. METHODS AND ANALYSIS 50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz, are randomised in a 1:1 ratio to reverse TAP or DK-crush stenting. As recommended by best clinical practice, final angiographic result is evaluated and optical coherence tomographic (OCT) intracoronary imaging is performed to assess and optimise the final result. The primary end point is defined as the percentage of stent expansion in the side branch. Secondary end points consist of angiographic and procedural success (assessed until patient's discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents. Safety parameters include all adverse events up to 6 months after discharge. A clinical, angiographic and intracoronary imaging control at 6 months is planned. ETHICS AND DISSEMINATION The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses. TRIAL REGISTRATION NUMBER ClinicalTrials.gov Registry (NCT03714750).",2020,"To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique. ","['50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz']","[""reverse T and Protrusion' (TAP) technique"", 'double kissing (DK)-crush technique', 'T And Protrusion versus double-kissing and crush', 'TAP or DK-crush stenting', 'stenting', 'TIP TAP']","[""angiographic and procedural success (assessed until patient's discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents"", 'percentage of stent expansion in the side branch', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.186743,"To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique. ","[{'ForeName': 'Kudrat', 'Initials': 'K', 'LastName': 'Rakhimov', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buono', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Anadol', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ullrich', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Knorr', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahoopai', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany tommaso.gori@unimedizin-mainz.de.'}]",BMJ open,['10.1136/bmjopen-2019-034264'] 1869,32554737,Individual breastfeeding support with contingent incentives for low-income mothers in the USA: the 'BOOST (Breastfeeding Onset & Onward with Support Tools)' randomised controlled trial protocol.,"INTRODUCTION National breastfeeding rates have improved in recent years, however, disparities exist by socioeconomic and psychosocial factors. Suboptimal breastfeeding overburdens the society by increasing healthcare costs. Existing breastfeeding supports including education and peer support have not been sufficient in sustaining breastfeeding rates especially among low-income women. The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding among mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC). METHODS AND ANALYSIS This trial uses a parallel randomised controlled trial. This trial is conducted at two sites in separate states in the USA. Mothers who were enrolled in WIC and initiated breastfeeding are eligible. Participants (n=168) are randomised into one of the two study groups: (1) standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding. All participants receive standard breastfeeding services from WIC, home-based individual support and assessments. Participants in SC receive financial compensation based on the number of completed monthly home visits, paid in a lump sum at the end of the 6-month intervention period. Participants in SC +BFI receive an escalating magnitude of financial incentives contingent on observed breastfeeding, paid monthly during the intervention period, as well as bonus incentives for selecting full breastfeeding food packages at WIC. The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC. The primary outcome is the rate of any breastfeeding over 12 months. Randomisation is completed in an automated electronic system. Staff conducting home visits for support and assessments are blinded to study groups. ETHICS AND DISSEMINATION The Advarra Institutional Review Board has approved the study protocol (Pro00033168). Findings will be disseminated to our participants, scientific communities, public health officials and any other interested community members. TRIAL REGISTRATION NUMBER NCT03964454.",2020,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"['Mothers who were enrolled in WIC and initiated breastfeeding are eligible', 'Participants (n=168', 'mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC', 'low-income mothers in the USA']","['standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding', 'standard breastfeeding services from WIC, home-based individual support and assessments']",['rate of any breastfeeding over 12\u2009months'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0985776,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Washio', 'Affiliation': 'Substance Use, Gender and Applied Research, RTI International, Research Triangle Park, North Carolina, USA ywashio@rti.org.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hunt-Johnson', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Zugui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Value Institute, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Herrine', 'Affiliation': 'Obstetrics and Gynecology Department, Temple University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Obstetrics and Gynecology Department, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kilby', 'Affiliation': 'N.O.R.T.H., Inc-Philadelphia WIC program, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Chapman', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Furman', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}]",BMJ open,['10.1136/bmjopen-2019-034510'] 1870,32554744,Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial.,"INTRODUCTION Women with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB). Given the burden of prematurity and its attendant risks, the quest for effective interventions in twins has been an area of considerable research. Studies investigating the effectiveness of cervical cerclage, cervical pessary and vaginal progesterone in preventing PTB have yielded conflicting results. The aim of this study is to compare the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone to prevent PTB in women with twin pregnancies and a cervical length (CL) ≤ 28 mm. METHODS AND ANALYSIS This multicentre, randomised clinical trial will be conducted at My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm, measured at 16-22 weeks' gestation, will be randomised in a 1:1:1:1 ratio to receive a cerclage, pessary, cerclage plus progesterone or pessary plus progesterone. Primary outcome will be PTB <34 weeks. Secondary outcomes will be maternal and neonatal complications. We preplanned a subgroup analysis according to CL from all women after randomisation and divided into four quartiles. Analysis will be conducted on an intention-to-treat basis. The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%. A sample size of 340 women will be required to show or refute that cervical cerclage decreases the rate of PTB <34 weeks by 50% compared with pessary (from 24.2% to 12.1%, α level 0.05, power 80%, 5% lost to follow-up and protocol deviation). This study is not to be powered to assess interactions between interventions. ETHICS AND DISSEMINATION Ethical approval was obtained from the Institutional Ethics Committee of My Duc Hospital and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT03863613 (date of registration: 4 March 2019).",2020,The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%.,"['Women with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB', 'women with twin pregnancies and a short cervix', ""Asymptomatic women with twin pregnancies and a CL ≤28\u2009mm, measured at 16-22 weeks' gestation"", 'My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam', '340 women', 'women with twin pregnancies and a cervical length (CL) ≤ 28\u2009mm']","['cerclage, pessary, cerclage plus progesterone or pessary plus progesterone', 'cervical cerclage, cervical pessary and vaginal progesterone', 'cervical pessary', 'cervical pessary and cervical cerclage with or without vaginal progesterone', 'cervical cerclage with or without vaginal progesterone']","['preterm birth', 'maternal and neonatal complications', 'rate of PTB']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C4517730', 'cui_str': '340'}]","[{'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0195681', 'cui_str': 'Cerclage of uterine cervix'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",340.0,0.402334,The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%.,"[{'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam bsvinh.dq@myduchospital.vn.'}, {'ForeName': 'Yen Tn', 'Initials': 'YT', 'LastName': 'He', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ha Nh', 'Initials': 'HN', 'LastName': 'Pham', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Tuyen Tt', 'Initials': 'TT', 'LastName': 'Trieu', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Trung Q', 'Initials': 'TQ', 'LastName': 'Bui', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nhu T', 'Initials': 'NT', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Loc Mt', 'Initials': 'LM', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Diem Tn', 'Initials': 'DT', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Thanh V', 'Initials': 'TV', 'LastName': 'Le', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Cam H', 'Initials': 'CH', 'LastName': 'Le', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at HCMC, Ho Chi Minh City, Viet Nam.'}]",BMJ open,['10.1136/bmjopen-2019-036587'] 1871,32539907,Implementing shared decision-making on acute psychiatric wards: a cluster-randomized trial with inpatients suffering from schizophrenia (SDM-PLUS).,"AIMS Although shared decision-making (SDM) has the potential to improve health outcomes, psychiatrists often exclude patients with more severe mental illnesses or more acute conditions from participation in treatment decisions. This study examines whether SDM is facilitated by an approach which is specifically adapted to the needs of acutely ill patients (SDM-PLUS). METHODS The study is a multi-centre, cluster-randomised, non-blinded, controlled trial of SDM-PLUS in 12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder. All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward. Treatment teams of intervention wards were trained in the SDM-PLUS approach through participation in two half-day workshops. Patients on intervention wards received group training in SDM. Staff (and patients) of the control wards acted under 'treatment as usual' conditions. The primary outcome parameter was the patients' perceived involvement in decision-making at 3 weeks after study enrolment, analysed using a random-effects linear regression model. RESULTS In total, 161 participants each were recruited in the intervention and control group. SDM-PLUS led to higher perceived involvement in decision-making (primary outcome, analysed patients n = 257, mean group difference 16.5, 95% CI 9.0-24.0, p = 0.002, adjusted for baseline differences: β 17.3, 95% CI 10.8-23.6, p = 0.0004). In addition, intervention group patients exhibited better therapeutic alliance, treatment satisfaction and self-rated medication compliance during inpatient stay. There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up. CONCLUSIONS Despite limitations in patient recruitment, the SDM-PLUS trial has shown that the adoption of behavioural approaches (e.g. motivational interviewing) for SDM may yield a successful application to mental health. The authors recommend strategies to ensure effects are not lost at the interface between in- and outpatient treatment.Trial registration: The trial was registered at Deutsches Register Klinischer Studien (DRKS00010880).",2020,"There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up. ","['inpatients suffering from schizophrenia (SDM-PLUS', '12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder', '161 participants each were recruited in the intervention and control group', 'acutely ill patients (SDM-PLUS', 'All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward']","['SDM', 'group training in SDM', 'SDM-PLUS']","['adherence and rehospitalisation rates', 'therapeutic alliance, treatment satisfaction and self-rated medication compliance', ""patients' perceived involvement in decision-making""]","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",161.0,0.200858,"There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up. ","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Holzhüter', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Blakaj', 'Affiliation': 'Isar-Amper-Klinikum München Ost, Haar, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Becher', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Institut für Medizinische Informatik, Statistik und Epidemiologie, Technische Universität München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Landgrebe', 'Affiliation': 'Lech Mangfall Klinikum, Agatharied, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmauß', 'Affiliation': 'Bezirkskrankenhaus Augsburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'Isar-Amper-Klinikum München Ost, Haar, Germany.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000505'] 1872,32540134,Event-related desynchronization of alpha and beta band neural oscillations predicts speech and limb motor timing deficits in normal aging.,"Normal aging is associated with decline of motor timing mechanisms implicated in planning and execution of movement. Evidence from previous studies has highlighted the relationship between neural oscillatory activities and motor timing processing in neurotypical younger adults; however, it remains unclear how normal aging affects the underlying neural mechanisms of movement in older populations. In the present study, we recorded EEG activities in two groups of younger and older adults while they performed randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli. Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli. This behavioral effect was accompanied by significant desynchronization of alpha (7-12 Hz) and beta (13-25 Hz) band neural oscillatory activities in older compared with younger adults, primarily during the preparatory pre-motor phase of responses for speech production and limb movement. In addition, we found that faster motor reaction times in younger adults were significantly correlated with weaker desynchronization of pre-motor alpha and beta band neural activities irrespective of stimulus timing and response modality. However, the pre-motor components of alpha and beta activities were timing-specific in older adults and were more strongly desynchronized in response to temporally predictable sensory stimuli. These findings highlight the role of alpha and beta band neural oscillations in motor timing processing mechanisms and reflect their functional deficits during the planning phase of speech production and limb movement in normal aging.",2020,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","['Normal Aging', 'neurotypical younger adults', 'two groups of younger and older adults', 'older adults']",['randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli'],['faster motor reaction times'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0320888,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States; Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States. Electronic address: r-behroozmand@sc.edu.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112763'] 1873,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy+cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy+cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed. MATERIALS AND METHODS Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40 mg/m 2 weekly) in combination with concurrent cetuximab (loading dose 400 mg/m 2 , then 250 mg/m 2 weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m 2 biweekly × 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed. RESULTS Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p ≤ 0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers. CONCLUSIONS There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011'] 1874,32540725,Significant immunomodulatory properties of curcumin in patients with osteoarthritis; a successful clinical trial in Iran.,"Osteoarthritis (OA) routinely is known as a multifactorial degenerative joint disease. This trial aimed to assess the curcumin (an active element of turmeric) effects on the immune responses in OA patients. Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups; intervention (received Sinacurcumin® 80 mg daily) and placebo, followed for 3 months. In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 + and CD8 + T cells, Th17 cells and B cells frequency. Additionally, Treg cells indicated a significant increase and Treg/Th17 cells ratio showed a meaningfully shifted toward Treg lymphocytes. In conclusion, our data indicated that clinical manifestation was ameliorated considerably following the administration of curcumin. Moreover, our data demonstrated the immunomodulatory effects of curcumin in OA patients.",2020,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 + and CD8 + T cells, Th17 cells and B cells frequency.","['Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups', 'patients with osteoarthritis', 'OA patients']","['intervention (received Sinacurcumin® 80\xa0mg daily) and placebo', 'curcumin']","['Visual Analog Score (VAS), C-reactive protein (CRP), CD4 + and CD8 + T cells, Th17 cells and B cells frequency']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.0327408,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 + and CD8 + T cells, Th17 cells and B cells frequency.","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Atabaki', 'Affiliation': 'Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Shariati-Sarabi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Tavakkol-Afshari', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: mohammadimzh@mums.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106607'] 1875,32540779,Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study.,"OBJECTIVE To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty. STUDY DESIGN prospective randomized study. SETTING Tertiary academic center. SUBJECTS and methods: Children with ankyloglossia with articulation difficulty were randomly divided into 2 groups for surgical treatment. Patients were evaluated for the tongue-tie classification and articulation test before surgery. Three months after the operation, the frenulum classification and articulation test were re-evaluated to compare the differences in surgical outcome between the two surgical methods. RESULTS Out of 37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy. No differences were observed in the baseline characteristics of the patients assigned to both groups. Changes in the tongue-tie classification and improvement in the articulation test results were observed with both the surgical methods. Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups. CONCLUSION Although there was no significant difference in the surgical outcome between the two surgical methods, ankyloglossia patients showed improvement in a Korean speech articulation test 3 months after undergoing surgery to release the lingual frenulum.",2020,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups. ","['patients with ankyloglossia with articulation difficulty', 'ankyloglossia with articulation difficulty', 'and methods', 'Children with ankyloglossia with articulation difficulty', 'Tertiary academic center', '37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy']","['simple frenotomy and the 4-flap Z-frenuloplasty', 'simple frenotomy with 4-flap Z-frenuloplasty']","['speech articulation test', 'speech outcomes', 'surgical outcome', 'Korean speech articulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152415', 'cui_str': 'Tongue tie'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0037819', 'cui_str': 'Speech Articulation Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",37.0,0.0322658,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups. ","[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Don', 'Initials': 'SD', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Eun', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ygeun@khu.ac.kr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110146'] 1876,32540886,"Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.","INTRODUCTION In multisite intervention trials, implementation success often varies widely across settings. Process evaluations are crucial to interpreting trial outcomes and understanding contextual factors and causal chains necessary for successful implementation. Lynch syndrome is a hereditary cancer predisposition conferring an increased risk of colorectal, endometrial and other cancer types. Despite systematic screening protocols to identify Lynch syndrome, the condition remains largely underdiagnosed. The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks. To enhance widespread implementation of optimal Lynch syndrome identification, there is a need to understand not only what works, but also why, in what contexts, and at what costs. Here we describe an in-depth investigation of factors influencing successful implementation of procedures evaluated in the HaSP trial. METHODS AND ANALYSIS A mixed-methods, theory-driven process evaluation will be undertaken in parallel to the HaSP trial. Data will include: interviews of Implementation Leads and Lynch syndrome stakeholders, pre-post implementation questionnaires, audio analysis of meetings and focus groups, observation of multidisciplinary team meetings, fidelity checklists and project log analysis. Results will be triangulated and coded, drawing on the Theoretical Domains Framework, Consolidated Framework for Implementation Research and Proctor's implementation outcomes. ETHICS AND DISSEMINATION Use of a theory-based process evaluation will enhance interpretation and generalisability of HaSP trial findings, and contribute to the implementation research field by furthering understanding of the conditions necessary for implementation success. Ethical approval has been granted and results will be disseminated via publications in peer-reviewed journals and conference presentations. At trial completion, key findings will be fed back to sites to enable refinement of intervention strategies, both in the context of Lynch syndrome and for the possible generalisability of intervention components in other genetic and broader clinical specialties. HASP TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (Identifier: ACTRN12618001072202). Registered 27 June 2018. http://www.ANZCTR.org.au/ACTRN12618001072202.aspx.",2020,The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks.,['Australian hospitals'],[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],,0.147946,The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks.,"[{'ForeName': 'April', 'Initials': 'A', 'LastName': 'Morrow', 'Affiliation': 'Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia april.morrow@nswcc.org.au.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Tucker', 'Affiliation': 'Hereditary Cancer Clinic, Prince of Wales Hospital and Community Health Services, Randwick, New South Wales, Australia.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Shaw', 'Affiliation': 'Research in Implementation Science and eHealth (RISe), Faculty of Health Sciences, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Bonny', 'Initials': 'B', 'LastName': 'Parkinson', 'Affiliation': 'The Macquarie University Centre for the Health Economy, Macquarie University, Macquarie, New South Wales, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Taylor', 'Affiliation': 'Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033552'] 1877,32541288,Cost of Elective Labor Induction Compared With Expectant Management in Nulliparous Women.,"OBJECTIVE To compare the actual health-system cost of elective labor induction at 39 weeks of gestation with expectant management. METHODS This was an economic analysis of patients enrolled in the five Utah hospitals participating in a multicenter randomized trial of elective labor induction at 39 weeks of gestation compared with expectant management in low-risk nulliparous women. The entire trial enrolled more than 6,000 patients. For this subset, 1,201 had cost data available. The primary outcome was relative direct health care costs of maternal and neonatal care from a health system perspective. Secondary outcomes included the costs of each phase of maternal and neonatal care. Direct health system costs of maternal and neonatal care were measured using advanced costing analytics from the time of randomization at 38 weeks of gestation until exit from the study up to 8 weeks postpartum. Costs in each randomization arm were compared using generalized linear models and reported as the relative cost of induction compared with expectant management. With a fixed sample size, we had adequate power to detect a 7.3% or greater difference in overall costs. RESULTS The total cost of elective induction was no different than expectant management (mean difference +4.7%; 95% CI -2.1% to +12.0%; P=.18). Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001). Maternal inpatient intrapartum and delivery care costs, conversely, were 16.9% higher among women undergoing labor induction (95% CI +5.5% to +29.5%; P=.003). Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge did not differ between arms. CONCLUSION Total costs of elective labor induction and expectant management did not differ significantly. These results challenge the assumption that elective induction of labor leads to significant cost escalation.",2020,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"['low-risk nulliparous women', 'patients enrolled in the five Utah hospitals participating', '6,000 patients', 'Nulliparous Women']","['Expectant Management', 'elective labor induction', 'expectant management']","['Maternal outpatient antenatal care costs', 'total cost of elective induction', 'Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge', 'costs of each phase of maternal and neonatal care', 'overall costs', 'Cost of Elective Labor Induction', 'relative direct health care costs of maternal and neonatal care from a health system perspective', 'Maternal inpatient intrapartum and delivery care costs']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}]",,0.122938,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Einerson', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and the Division of Epidemiology, Department of Internal Medicine, University of Utah Health, Intermountain Healthcare, and the IDEAS Center, VA Salt Lake City Healthcare System, Salt Lake City, Utah; George Washington University Biostatistics Center, Washington, DC; the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': ''}, {'ForeName': 'M Sean', 'Initials': 'MS', 'LastName': 'Esplin', 'Affiliation': ''}, {'ForeName': 'D Ware', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': ''}, {'ForeName': 'Torri D', 'Initials': 'TD', 'LastName': 'Metz', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003930'] 1878,32541380,5-Hydroxytryptophan as adjuvant therapy in treatment of moderate to severe obsessive-compulsive disorder: a double-blind randomized trial with placebo control.,"On the basis of numerous previous studies, the serotonergic system plays a role in the pathogenesis of obsessive-compulsive disorder (OCD) and effective agents in this pathway, such as 5-hydroxytryptophan, can potentially contribute to treatment of patients with this disorder. Evaluating the efficacy of 5-hydroxytryptophan in treating OCD was the aim of the present randomized, double-blind, placebo-controlled 12-week trial. In a 12-week, randomized double-blind study, 60 patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of moderate to severe OCD and a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of >21 were randomly assigned to receive either fluoxetine plus placebo or fluoxetine plus 5-hydroxytryptophan (100 mg twice daily). All patients, regardless of their treatment group, received fluoxetine at 20 mg/day for the initial 4 weeks of the study followed by 60 mg/day of fluoxetine for the rest of the trial course. Symptoms were assessed using the Y-BOCS at baseline and weeks 4, 8 and 12. General linear model repeated measure showed significant effects for time × treatment interaction on total Y-BOCS (F = 12.07, df = 2.29, P-value <0.001), obsession (F = 8.25, df = 1.91, P-value = 0.001) and compulsion subscale scores (F = 6.64, df = 2.01, P-value = 0.002). 5-Hydroxytryptophan augmentation therapy demonstrated higher partial and complete treatment response rate (P = 0.032 and P = 0.001, respectively) according to the Y-BOCS total scores. The results of this study confirm that 5-hydroxytryptophan may be effective as an augmentative agent in treatment of moderate-to-severe OCD.",2020,"5-Hydroxytryptophan augmentation therapy demonstrated higher partial and complete treatment response rate (P = 0.032 and P = 0.001, respectively) according to the Y-BOCS total scores.","['moderate to severe obsessive-compulsive disorder', '60 patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of moderate to severe OCD and a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of >21', 'patients with this disorder']","['5-Hydroxytryptophan', '5-hydroxytryptophan', 'fluoxetine', 'fluoxetine plus placebo or fluoxetine plus 5-hydroxytryptophan', '5-Hydroxytryptophan augmentation therapy', 'placebo']","['compulsion subscale scores', 'total Y-BOCS', 'higher partial and complete treatment response rate']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",60.0,0.0988532,"5-Hydroxytryptophan augmentation therapy demonstrated higher partial and complete treatment response rate (P = 0.032 and P = 0.001, respectively) according to the Y-BOCS total scores.","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Yousefzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sahebolzamani', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Sadri', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Mortezaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aqamolaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Seyyed Hosein', 'Initials': 'SH', 'LastName': 'Mortazavi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Mohammd Reza', 'Initials': 'MR', 'LastName': 'Shalbafan', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences.'}, {'ForeName': 'Salomeh', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'School of Persian Medicine, Iran University of Medical Sciences, Research Institute for Islamic and Complementory Medicine.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Alikhani', 'Affiliation': 'Psychosis Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Seiedeh Bentolhoda', 'Initials': 'SB', 'LastName': 'Mousavi', 'Affiliation': 'Psychosis Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naderi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shamabadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Shakiba', 'Initials': 'S', 'LastName': 'Jalilevand', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000321'] 1879,32534646,"Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAF V600 mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND IMspire150 aimed to evaluate first-line combination treatment with BRAF plus MEK inhibitors and immune checkpoint therapy in BRAF V600 mutation-positive advanced or metastatic melanoma. METHODS IMspire150 was a randomised, double-blind, placebo-controlled phase 3 study done at 112 institutes in 20 countries. Patients with unresectable stage IIIc-IV, BRAF V600 mutation-positive melanoma were randomly assigned 1:1 to 28-day cycles of atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) or atezolizumab placebo, vemurafenib, and cobimetinib (control group). In cycle 1, all patients received vemurafenib and cobimetinib only; atezolizumab placebo was added from cycle 2 onward. Randomisation was stratified by lactate dehydrogenase concentration and geographical region. Blinding for atezolizumab was achieved by means of an identical intravenous placebo, and blinding for vemurafenib was achieved by means of a placebo tablet. The primary outcome was investigator-assessed progression-free survival. This trial (ClinicalTrials.gov, NCT02908672) is ongoing but no longer recruiting patients. FINDINGS Between Jan 13, 2017, and April 26, 2018, 777 patients were screened and 514 were enrolled and randomly assigned to the atezolizumab group (n=256) or control group (n=258). At a median follow-up of 18·9 months (IQR 10·4-23·8), progression-free survival as assessed by the study investigator was significantly prolonged with atezolizumab versus control (15·1 vs 10·6 months; hazard ratio [HR] 0·78; 95% CI 0·63-0·97; p=0·025). Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events. INTERPRETATION The addition of atezolizumab to targeted therapy with vemurafenib and cobimetinib was safe and tolerable and significantly increased progression-free survival in patients with BRAF V600 mutation-positive advanced melanoma. FUNDING F Hoffmann-La Roche and Genentech.",2020,"Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events. ","['Between Jan 13, 2017, and April 26, 2018, 777 patients were screened and 514 were enrolled and randomly assigned to the', 'Patients with unresectable stage IIIc-IV, BRAF V600 mutation-positive melanoma', 'patients with BRAF V600 mutation-positive advanced melanoma', 'controlled phase 3 study done at 112 institutes in 20 countries', 'BRAF V600 mutation-positive advanced or metastatic melanoma', 'group (n=256) or control group (n=258']","['BRAF plus MEK inhibitors', 'Atezolizumab, vemurafenib, and cobimetinib', 'atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) or atezolizumab placebo, vemurafenib, and cobimetinib (control group', 'atezolizumab', 'vemurafenib and cobimetinib only; atezolizumab placebo', 'vemurafenib and cobimetinib', 'placebo']","['progression-free survival', 'diarrhoea', 'pyrexia', 'alanine aminotransferase', 'investigator-assessed progression-free survival', 'blood creatinine phosphokinase', 'adverse events', 'rash', 'arthralgia', 'lipase']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0383375', 'cui_str': 'AT 112'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",777.0,0.732647,"Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events. ","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Haut-Tumor-Zentrum Hannover, Klinik für Dermatologie, Allergologie und Venerologie, Medizinische Hochschule Hannover, Hannover, Germany. Electronic address: gutzmer.ralf@mh-hannover.de.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital Number 62 of Moscow Healthcare Department, Moscow, Russia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Université Paris-Saclay, Villejuif-Paris, France.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Comprehensive Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Protsenko', 'Affiliation': 'Department of Chemotherapy and Innovative Technologies, NN Petrov National Medical Research Center of Oncology, St Petersburg, Russia.'}, {'ForeName': 'Rodrigo P', 'Initials': 'RP', 'LastName': 'Pereira', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eigentler', 'Affiliation': 'University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue-Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'NN Blokhin Russian Cancer Research Center, Ministry of Health, Moscow, Russia.'}, {'ForeName': 'Georgy Moiseevich', 'Initials': 'GM', 'LastName': 'Manikhas', 'Affiliation': 'St Petersburg Oncology Hospital, St Petersburg, Russia.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Kuan-Chieh', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyei', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'McNally', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'McArthur', 'Affiliation': 'Melanoma and Skin Service and Cancer Therapeutics Program, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Naples, Italy.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30934-X'] 1880,32534647,"Cancer prevention with aspirin in hereditary colorectal cancer (Lynch syndrome), 10-year follow-up and registry-based 20-year data in the CAPP2 study: a double-blind, randomised, placebo-controlled trial.","BACKGROUND Lynch syndrome is associated with an increased risk of colorectal cancer and with a broader spectrum of cancers, especially endometrial cancer. In 2011, our group reported long-term cancer outcomes (mean follow-up 55·7 months [SD 31·4]) for participants with Lynch syndrome enrolled into a randomised trial of daily aspirin versus placebo. This report completes the planned 10-year follow-up to allow a longer-term assessment of the effect of taking regular aspirin in this high-risk population. METHODS In the double-blind, randomised CAPP2 trial, 861 patients from 43 international centres worldwide (707 [82%] from Europe, 112 [13%] from Australasia, 38 [4%] from Africa, and four [<1%] from The Americas) with Lynch syndrome were randomly assigned to receive 600 mg aspirin daily or placebo. Cancer outcomes were monitored for at least 10 years from recruitment with English, Finnish, and Welsh participants being monitored for up to 20 years. The primary endpoint was development of colorectal cancer. Analysis was by intention to treat and per protocol. The trial is registered with the ISRCTN registry, number ISRCTN59521990. FINDINGS Between January, 1999, and March, 2005, 937 eligible patients with Lynch syndrome, mean age 45 years, commenced treatment, of whom 861 agreed to be randomly assigned to the aspirin group or placebo; 427 (50%) participants received aspirin and 434 (50%) placebo. Participants were followed for a mean of 10 years approximating 8500 person-years. 40 (9%) of 427 participants who received aspirin developed colorectal cancer compared with 58 (13%) of 434 who received placebo. Intention-to-treat Cox proportional hazards analysis revealed a significantly reduced hazard ratio (HR) of 0·65 (95% CI 0·43-0·97; p=0·035) for aspirin versus placebo. Negative binomial regression to account for multiple primary events gave an incidence rate ratio of 0·58 (0·39-0·87; p=0·0085). Per-protocol analyses restricted to 509 who achieved 2 years' intervention gave an HR of 0·56 (0·34-0·91; p=0·019) and an incidence rate ratio of 0·50 (0·31-0·82; p=0·0057). Non-colorectal Lynch syndrome cancers were reported in 36 participants who received aspirin and 36 participants who received placebo. Intention-to-treat and per-protocol analyses showed no effect. For all Lynch syndrome cancers combined, the intention-to-treat analysis did not reach significance but per-protocol analysis showed significantly reduced overall risk for the aspirin group (HR=0·63, 0·43-0·92; p=0·018). Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously. INTERPRETATION The case for prevention of colorectal cancer with aspirin in Lynch syndrome is supported by our results. FUNDING Cancer Research UK, European Union, MRC, NIHR, Bayer Pharma AG, Barbour Foundation.",2020,"Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously. ","['861 patients from 43 international centres worldwide (707 [82%] from Europe, 112 [13%] from Australasia, 38 [4%] from Africa, and four [<1%] from The Americas) with Lynch syndrome', 'hereditary colorectal cancer (Lynch syndrome', 'Participants were followed for a mean of 10 years approximating 8500 person-years', '937 eligible patients with Lynch syndrome, mean age 45 years, commenced treatment, of whom 861 agreed to be randomly assigned to the', '427 participants who received', 'and 36 participants who received']","['aspirin group or placebo', 'aspirin versus placebo', 'aspirin', 'aspirin daily or placebo', 'placebo']","['development of colorectal cancer', 'Adverse events', 'long-term cancer outcomes', 'hazard ratio (HR) of 0·65', 'overall risk', 'colorectal cancer', 'compliance', 'Cancer outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0282279', 'cui_str': 'Australasia'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517893', 'cui_str': '8500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",861.0,0.749563,"Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously. ","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. Electronic address: john.burn@newcastle.ac.uk.'}, {'ForeName': 'Harsh', 'Initials': 'H', 'LastName': 'Sheth', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Elliott', 'Affiliation': ""Division of Haematology and Immunology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Reed', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Finlay', 'Initials': 'F', 'LastName': 'Macrae', 'Affiliation': 'Colorectal Medicine and Genetics, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Jukka-Pekka', 'Initials': 'JP', 'LastName': 'Mecklin', 'Affiliation': 'Department of Education & Research, Jyväskylä Central Hospital, Jyväskylä, Finland; Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Möslein', 'Affiliation': 'St Josefs-Hospital, Bochum-Linden, Germany.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'McRonald', 'Affiliation': 'National Cancer Registration and Analysis Service, Public Health England, London, UK.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Bertario', 'Affiliation': 'Instituto Nazionale per lo Studio e, la Cura dei Tumori, Milan, Italy.'}, {'ForeName': 'D Gareth', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': ""Division of Evolution and Genomic Medicine, University of Manchester, Manchester, UK; St Mary's Hospital, Manchester Universities Foundation Trust, Manchester, UK.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Gerdes', 'Affiliation': 'Clinical Genetics, Rigshospital, Copenhagen, Denmark.'}, {'ForeName': 'Judy W C', 'Initials': 'JWC', 'LastName': 'Ho', 'Affiliation': 'Hereditary GI Cancer Registry, Department of Surgery, Queen Mary Hospital, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Lindblom', 'Affiliation': 'Department of Molecular Medicine & Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Morrison', 'Affiliation': 'Department of Medical Genetics, Queens University Belfast, Belfast City Hospital HSC Trust, Belfast, UK.'}, {'ForeName': 'Jem', 'Initials': 'J', 'LastName': 'Rashbass', 'Affiliation': 'National Cancer Registration and Analysis Service, Public Health England, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Ramesar', 'Affiliation': 'Genomic and Precision Medicine Research Unit, Division of Human Genetics, Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Seppälä', 'Affiliation': 'Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Huw J W', 'Initials': 'HJW', 'LastName': 'Thomas', 'Affiliation': ""St Mark's Hospital, London, UK; Faculty of Medicine, Imperial College London, London, UK.""}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pylvänäinen', 'Affiliation': 'Department of Education & Research, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Borthwick', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'D Timothy', 'Initials': 'DT', 'LastName': 'Bishop', 'Affiliation': ""Division of Haematology and Immunology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30366-4'] 1881,32535138,The effects of foam roll on perceptual and performance recovery during a futsal tournament.,"The present study investigated the efficacy of recovery by foam rolling (FR) on performance, psychological, and physiological parameters of futsal players in a simulated futsal tournament. In this randomized controlled trial design, four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches). Sixteen youth futsal players from two teams (age: 19.1 ± 1.3 years old) were randomly distributed into two groups: (i) passive recovery (PR); and (ii) FR recovery. The FR recovery protocol consisted of five repetitions of 40 s separated by 20 s of rest on calf, quadriceps, hamstrings, and gluteus muscles 5 min after each match. The other group rested passively during the same period. The Yo-Yo intermittent recovery level 2, repeated sprint ability, vertical jump, and PRO agility tests were assessed pre- and post-tournament. Also, Hooper index (HI) and blood lactate concentrations were measured throughout matchdays. Data were analyzed by a repeated measure ANOVA and ANCOVA. Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05). Although FR recovery was slightly beneficial when compared to PR attenuated decrements in aerobic (-1.6%vs-9.7%) and anaerobic performance (-4.5%vs-1.3%), vertical jump (-1.6%vs-3.0%), and change of direction (-2.1%vs-4.3%), these effects were not statistically significant (p>0.05). The finding showed using FR during compact competitions expedites physical performance recovery, increases blood lactate clearance and leads to regenerate psychological characteristics. Therefore, along with other desirable recovery strategies, the use of FR could be recommended in short-term compacted futsal tournaments.",2020,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"['Sixteen youth futsal players from two teams (age: 19.1±1.3 years old', ""four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches"", 'futsal players in a simulated futsal tournament']","['passive recovery (PR); and (ii) FR recovery', 'foam rolling (FR', 'foam roll']","['Hooper index (HI) and blood lactate concentrations', 'perceptual and performance recovery', 'repeated sprint ability, vertical jump, and PRO agility tests', 'lactate removal', 'blood lactate clearance', 'anaerobic performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0276004,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347, Viana do Castelo, Portugal; Instituto de Telecomunicações, Delegação da Covilhã, Lisboa 1049-001, Portugal. Electronic address: filipeclemente@esdl.ipvc.pt.""}]",Physiology & behavior,['10.1016/j.physbeh.2020.112981'] 1882,32543682,Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial.,"Importance Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. Objective To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Design, Setting, and Participants Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Interventions Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). Main Outcomes and Measures The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Results Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8). Conclusions and Relevance Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit. Trial Registration ClinicalTrials.gov Identifier: NCT03240432.",2020,"Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001).","['older adults with type 1 diabetes', '22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes', 'Older Adults With Type 1 Diabetes', 'adults aged 60 years or older with type 1 diabetes', '203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used']","['CGM', 'standard blood glucose monitoring (BGM', 'CGM (n\u2009=\u2009103) or standard BGM', 'standard BGM', 'Importance\n\n\nContinuous glucose monitoring (CGM', 'standard blood glucose monitoring', 'Continuous Glucose Monitoring']","['severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits', 'Hypoglycemia', 'Mean HbA1c', 'hypoglycemia', 'additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate', 'CGM-measured percentage of time that sensor glucose values', 'Median time with glucose levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",203.0,0.1795,"Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001).","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Rickels', 'Affiliation': 'Rodebaugh Diabetes Center, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ahmann', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes and Endocrinology Research Center, Des Moines.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, Georgia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Carlson', 'Affiliation': 'Park Nicollet International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Naomi S', 'Initials': 'NS', 'LastName': 'Chaytor', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'University of South California, School of Pharmacy, Los Angeles.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Naomi Berri Diabetes Center, Columbia University, New York, New York.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Kruger', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Philipson', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, La Jolla, California.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'University of Massachusetts Medical School, Worcester.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vendrame', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Alandra', 'Initials': 'A', 'LastName': 'Verdejo', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Kellee M', 'Initials': 'KM', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.6928'] 1883,32543683,Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.,"Importance Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated. Objective To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes. Design, Setting, and Participants Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%. Interventions Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79). Main Outcomes and Measures The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate. Results Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group). Conclusions and Relevance Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings. Trial Registration ClinicalTrials.gov Identifier: NCT03263494.",2020,"Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01).","['Importance\n\n\nAdolescents and young adults with type 1 diabetes', 'Adolescents and Young Adults With Type 1 Diabetes', '153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study', 'adolescents and young adults with type 1 diabetes', 'January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9']","['CGM (CGM group; n\u2009=\u200974) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n\u2009=\u200979', 'continuous glucose monitoring (CGM', 'Continuous Glucose Monitoring', 'CGM']","['severe hypoglycemia', 'hyperglycemia/ketosis', 'Mean HbA1c', 'additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate', 'diabetic ketoacidosis', 'glycemic control', 'adverse events', 'change in HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202048', 'cui_str': 'Glucose measurement by monitoring device'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",3.0,0.108319,"Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01).","[{'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bergamo', 'Affiliation': 'University of North Carolina Diabetes Care Center, Chapel Hill.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Clements', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Criego', 'Affiliation': 'Health Partners Institute, International Diabetes Center, St Louis Park, Minnesota.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeSalvo', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Naomi Berrie Diabetes Center, Columbia University, New York, New York.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liljenquist', 'Affiliation': 'Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho.'}, {'ForeName': 'Laurel H', 'Initials': 'LH', 'LastName': 'Messer', 'Affiliation': ''}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Monzavi', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Mouse', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Prahalad', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': ""Yale Children's Diabetes Program, New Haven, Connecticut.""}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, Aurora, Colorado.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Willi', 'Affiliation': 'Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kellee M', 'Initials': 'KM', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.6940'] 1884,32543684,Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial.,"Importance Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS). Objective To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents. Design, Setting, and Participants A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019. Interventions Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529). Main Outcomes and Measures The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events. Results Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, -1.98% [95% CI, -3.50% to -0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). Conclusions and Relevance Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial. Trial Registration ClinicalTrials.gov Identifier: NCT02494895.",2020,"The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). ","['patients with acute coronary syndromes treated with drug-eluting stents', 'Patients', '3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea', 'patients with acute coronary syndromes (ACS', 'patients with ACS treated with drug-eluting stents', 'With Acute Coronary Syndrome', '3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial']","['DAPT', 'ticagrelor-based 12-month DAPT', 'Ticagrelor Monotherapy vs Ticagrelor', 'Aspirin', 'aspirin', 'ticagrelor monotherapy']","['major bleeding and cardiovascular events', 'Major Bleeding and Cardiovascular Events', 'incidence of major adverse cardiac and cerebrovascular events', 'Major bleeding', 'major bleeding and major adverse cardiac and cerebrovascular events', '1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",3056.0,0.102151,"The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). ","[{'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yun-Hyeong', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Kyeong Ho', 'Initials': 'KH', 'LastName': 'Yun', 'Affiliation': 'Wonkwang University Hospital, Iksan, South Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, South Korea.'}, {'ForeName': 'Yongsung', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Wonkwang University Hospital, Iksan, South Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, South Korea.'}, {'ForeName': 'Sungsoo', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Dankook University Hospital, Dankook University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'National Health Insurance Service Ilsan Hospital, Goyang-City, South Korea.'}, {'ForeName': 'Sang-Yong', 'Initials': 'SY', 'LastName': 'Yoo', 'Affiliation': 'Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea.'}, {'ForeName': 'Deok-Kyu', 'Initials': 'DK', 'LastName': 'Cho', 'Affiliation': 'Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea.'}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyuckmoon', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong-Ho', 'Initials': 'DH', 'LastName': 'Shin', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chung-Mo', 'Initials': 'CM', 'LastName': 'Nam', 'Affiliation': 'Department of Preventive Medicine and Biostatistics, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.7580'] 1885,32555938,Comparative clinical evaluation of breast augmentation using silicone foam coated implants and textured implants.,"PURPOSE To evaluate whether silicone foam implants have a different evolution pattern compared to conventional texture implants. METHODS Fifty-eight female patients underwent surgery. They were divided into two groups (silicone foam - Lifesil® - and microtexturized silicone - Lifesil®). The evolution was analyzed in postoperative consultations, with physical examination, photographic documentation and filling in a satisfaction questionnaire, in the postoperative period of one month, four months, one year and then annually, up to a maximum of 3 years of follow-up. RESULTS There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars. There was a higher rate of patients who were very satisfied with the outcome 360 days after surgery in the group receiving silicone foam implants (p = 0.036). CONCLUSION In short time, silicone foam envelope implants proved to be as reliable as textured silicone envelope implants, making them an option for augmentation mammoplasty.",2020,"There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars.",['Fifty-eight female patients underwent surgery'],"['silicone foam coated implants and textured implants', 'silicone foam - Lifesil® - and microtexturized silicone - Lifesil®', 'silicone foam implants']","['presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars', 'postoperative consultations, with physical examination, photographic documentation and filling in a satisfaction questionnaire']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",58.0,0.0308352,"There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars.","[{'ForeName': 'Ivana Leme de', 'Initials': 'IL', 'LastName': 'Calaes', 'Affiliation': 'Fellow PhD degree, Postgraduate Program in Surgical Sciences, Faculty of Medical Sciences, Universidade Estadual de Campinas (UNICAMP), Brazil. Scientific, intellectual, conception and design of the study; acquisition, analysis and interpretation of data; technical procedures; statistics analysis; manuscript preparation and writing; final approval.'}, {'ForeName': 'Marcos Matias', 'Initials': 'MM', 'LastName': 'Motta', 'Affiliation': 'Assistant Professor, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific and intellectual content of the study, technical procedures.'}, {'ForeName': 'Rafael de Campos', 'Initials': 'RC', 'LastName': 'Basso', 'Affiliation': 'Assistant Professor, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific and intellectual content of the study, statistics analysis.'}, {'ForeName': 'Davi Reis', 'Initials': 'DR', 'LastName': 'Calderoni', 'Affiliation': 'PhD, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific, intellectual, conception and design of the study; technical procedures; manuscript preparation.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Kharmandayan', 'Affiliation': 'Full Professor and Chairman, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific, intellectual, conception and design of the study; analysis and interpretation of data; technical procedures; manuscript preparation; critical revision; final approval.'}]",Acta cirurgica brasileira,['10.1590/s0102-865020200040000007'] 1886,32555939,"Randomized, double-blind, placebo-controlled study of the analgesic effect of intraoperative esmolol for laparoscopic gastroplasty.","PURPOSE To evaluate the analgesic effect of esmolol in patients submitted to laparoscopic gastroplasty. METHODS Forty patients aged between 18 and 50 years with American Society of Anesthesiologists (ASA) physical status scores of II and III who underwent gastric bypass were allocated to two groups. Group 1 patients received a 0.5-mg/kg bolus of esmolol in 30 mL of saline before induction of anesthesia, followed by an infusion at 15 µg/kg/min until the end of surgery. Group 2 patients received 30 mL of saline as a bolus and then an infusion of saline. Anesthesia included fentanyl (3 µg/kg), propofol (2-4 mg/kg), rocuronium (0.6 mg/kg), and 2% sevoflurane, with remifentanil if necessary. The following parameters were evaluated: pain intensity over 24h, remifentanil consumption, the first analgesic request, morphine consumption, and side effects. RESULTS Pain intensity was lower in the esmolol group except at T0 (after extubation) and 12h postoperatively. Remifentanil supplementation, recovery time, and postoperative morphine supplementation were lower in the esmolol group. No differences in the time to the first analgesic request or side effects were found between the groups. CONCLUSION Intraoperative esmolol promotes reductions in pain intensity and the need for analgesic supplementation without adverse effects, thus representing an effective drug for multimodal analgesia in gastroplasty.",2020,"RESULTS Pain intensity was lower in the esmolol group except at T0 (after extubation) and 12h postoperatively.","['Forty patients aged between 18 and 50 years with American Society of Anesthesiologists (ASA) physical status scores of II and III who underwent gastric bypass', 'patients submitted to laparoscopic gastroplasty', 'laparoscopic gastroplasty']","['rocuronium', 'sevoflurane, with remifentanil', 'Remifentanil', 'Intraoperative esmolol', 'intraoperative esmolol', 'esmolol', '30 mL of saline', 'propofol', 'placebo']","['pain intensity', 'analgesic effect', 'Pain intensity', 'time to the first analgesic request or side effects', 'recovery time, and postoperative morphine supplementation', 'pain intensity over 24h, remifentanil consumption, the first analgesic request, morphine consumption, and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017193', 'cui_str': 'Gastroplasty'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",40.0,0.357074,"RESULTS Pain intensity was lower in the esmolol group except at T0 (after extubation) and 12h postoperatively.","[{'ForeName': 'Vinicius Barros Duarte de', 'Initials': 'VBD', 'LastName': 'Morais', 'Affiliation': 'MD, Pain Sector, Department of Surgery, Universidade Federal de São Paulo (UNIFESP), Brazil, Design of the study, acquisition of data, final approval.'}, {'ForeName': 'Rioko Kimiko', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'PhD, Pain Sector, Department of Surgery, UNIFESP, Sao Paulo-SP, Brazil, Design of the study, manuscript writing, critical revision, final approval.'}, {'ForeName': 'Ana Paula Santana', 'Initials': 'APS', 'LastName': 'Huang', 'Affiliation': 'Master, Pain Sector, Department of Surgery, UNIFESP, Sao Paulo-SP, Brazil. Acquisition of data, final approval.'}, {'ForeName': 'Leonardo Henrique da Cunha', 'Initials': 'LHDC', 'LastName': 'Ferraro', 'Affiliation': 'PhD, Pain Sector, Department of Surgery, UNIFESP, Sao Paulo-SP, Brazil. Manuscript writing, final approval.'}]",Acta cirurgica brasileira,['10.1590/s0102-865020200040000008'] 1887,32556008,Dentinal Tubule Penetration of a Calcium Silicate-Based Root Canal Sealer Using a Specific Calcium Fluorophore.,"This study aimed to evaluate penetrability on dentinal tubule of a new bioceramic sealer through confocal laser scanning microscopy (CLSM). A specific fluorophore (Fluo-3) was mixed with the sealer. Forty distobuccal roots from maxillary molars were selected, and root canal preparation was carried out with Wave One Gold # 35.06 instruments. Roots were randomly assigned to 4 groups according to the filling procedures: Bioceramic/Lentulo (Sealer Plus BC); Bioceramic/EasyClean group, three activation of the sealer (3x20 s) with Easy Clean instrument; Bioceramic/Irrisonic: ultrasonic activation for 30 s; and AHplus/Lentulo: epoxy resin based sealer (AH Plus) was utilized with the same protocol as the BC/LE group. After 72 h, specimens were transversally sectioned at 2 and 7 mm from root apex and then analyzed through CLSM. Sealer penetration area on dentinal tubule was measured by Adobe Photoshop CC2018. Kruskal Wallis and Wilcoxon T tests were carried out. Penetrability results were similar for both sealers regardless of which technique was performed to activate them inside the root canal (p>0.05). It is reasonable to conclude that penetration of bioceramic and epoxy resin based sealers occurred unimpressively. The type of instrument used to activate bioceramic sealer did not affect penetrability. Fluo 3 should be recommended as the fluorophore to evaluate dentinal tubule penetration of bioceramic sealers.",2020,Penetrability results were similar for both sealers regardless of which technique was performed to activate them inside the root canal (p>0.05).,['Forty distobuccal roots from maxillary molars'],"['confocal laser scanning microscopy (CLSM', 'Calcium Silicate-Based Root Canal Sealer', 'filling procedures: Bioceramic/Lentulo (Sealer Plus BC); Bioceramic/EasyClean group, three activation of the sealer (3x20 s) with Easy Clean instrument; Bioceramic/Irrisonic: ultrasonic activation for 30 s; and AHplus/Lentulo: epoxy resin based sealer (AH']",['Sealer penetration area on dentinal tubule'],"[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1676076', 'cui_str': 'Sealer Plus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}]",,0.0177996,Penetrability results were similar for both sealers regardless of which technique was performed to activate them inside the root canal (p>0.05).,"[{'ForeName': 'Viviane Siqueira', 'Initials': 'VS', 'LastName': 'Coronas', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Villa', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Angela Longo do', 'Initials': 'ALD', 'LastName': 'Nascimento', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Pedro Henrique Marks', 'Initials': 'PHM', 'LastName': 'Duarte', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ricardo Abreu da', 'Initials': 'RAD', 'LastName': 'Rosa', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marcus Vinícius Reis', 'Initials': 'MVR', 'LastName': 'Só', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Brazilian dental journal,['10.1590/0103-6440202002829'] 1888,32559029,Regeneration of Secondary Dentin Using Recombinant Human Platelet-Derived Growth Factor and MTA for Pulp Capping: A Randomized Controlled Human Clinical Trial.,"This in vivo study assessed the effect of mineral trioxide aggregate (MTA) as a matrix carrier for recombinant human platelet-derived growth factor (rhPDGF) and enamel matrix protein (EMP) on pulp tissue healing following pulp capping. Eighteen intact human premolars scheduled for extraction were included. Coronal access and pulpotomy were performed, and each tooth was left exposed to the oral cavity for 1 hour before pulp capping was performed. Teeth were randomly assigned to one of the following pulp-capping groups (n = 6 each): Group 1 (MTA only); Group 2 (MTA+EMP); or Group 3 (MTA+rhPDGF). Coronal access cavities were then sealed. Immediate preoperative, postoperative, and 4-month follow-up radiographs were taken. At 4 months, the teeth were extracted atraumatically, and histomorphometric and micro-computed tomography (μCT) analyses were performed. Group 1 showed a thin, uneven, irregular dentin-like structure. Its average thickness was 0.3 ± 0.084 mm measured histologically and 0.29 ± 0.091 mm measured by μCT. Group 2 showed of a nonporous, even-thickness dentin-like structure with multiple root-canal obliterations. Highly dense, atubular dentin-like structures associated with presence of odontoblastic lacunae were seen. The structure's average thickness was 0.87 ± 0.09 mm (histologically) and 0.81 ± 0.17 mm (μCT). Group 3 showed a thick and complete 3D continuous seal of newly formed dentin-like structure covering the pulpal space. It resembled secondary dentin in form, porosity, and tubular structural organization, and its average thickness was 0.94 ± 0.02 mm (histologically) and 0.91 ± 0.09 mm (μCT). Groups 2 and 3 showed higher amounts of newly formed dentin-like structure, that was also thicker, than Group 1 ( P < .05). No statistically significant differences in structure thickness were found between Groups 2 and 3. The nature of the structure can differ if rhPDGF or EMP is added to MTA for pulp-capping purposes. Combination of rhPDGF and MTA resulted in a newly formed structure resembling secondary dentin, whereas a combination of EMP and MTA produced a nonporous, highly dense dentinal-like structure associated with significant root-canal obliterations.",2020,"Groups 2 and 3 showed higher amounts of newly formed dentin-like structure, that was also thicker, than Group 1 ( P < .05).",['Eighteen intact human premolars scheduled for extraction were included'],"['Recombinant Human Platelet-Derived Growth Factor and MTA', 'mineral trioxide aggregate (MTA', 'MTA+EMP); or Group 3 (MTA+rhPDGF', 'rhPDGF and MTA']","['structure thickness', 'odontoblastic lacunae', 'higher amounts of newly formed dentin-like structure']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1299006', 'cui_str': 'Human platelet-derived growth factor'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",,0.0272097,"Groups 2 and 3 showed higher amounts of newly formed dentin-like structure, that was also thicker, than Group 1 ( P < .05).","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Al-Hezaimi', 'Affiliation': ''}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Naghshbandi', 'Affiliation': ''}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Alhuzaimi', 'Affiliation': ''}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alonizan', 'Affiliation': ''}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'AlQwizany', 'Affiliation': ''}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Rotstein', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4766'] 1889,32559039,"Ridge Augmentation Comparing a Cancellous Block Allograft to an Osteoinductive Demineralized Bone Matrix Allograft: A Randomized, Controlled, Blinded Clinical Trial.","Twenty-six patients with a horizontal ridge defect were entered into this 4-month randomized, controlled, blinded clinical trial to compare a cancellous block allograft to a demineralized bone matrix (DBM) allograft for ridge augmentation. Six patients were excluded from the study, leaving 20 for data interpretation. Both groups had a xenograft overlay and a collagen membrane. For the Block group there was a significant gain of 4.8 ± 1.9 mm ( P = .00002; 95% confidence interval [CI]: 3.49 to 6.21), while the DBM group gained 4.6 ± 2.4 mm ( P = .0002; 95% CI: 2.88 to 6.36). Vertical change was minimal for both groups ( P > .05). The Block group had a mean of 40% vital bone while the DBM group had 35%.",2020,For the Block group there was a significant gain of 4.8 ± 1.9 mm ( P = .00002,"['Six patients were excluded from the study, leaving 20 for data interpretation', 'Twenty-six patients with a horizontal ridge defect']","['cancellous block allograft to a demineralized bone matrix (DBM) allograft for ridge augmentation', 'Ridge Augmentation Comparing a Cancellous Block Allograft']","['mean of 40% vital bone', 'Vertical change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",6.0,0.213756,For the Block group there was a significant gain of 4.8 ± 1.9 mm ( P = .00002,"[{'ForeName': 'Bobby Lee', 'Initials': 'BL', 'LastName': 'Cockerham', 'Affiliation': ''}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Greenwell', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shumway', 'Affiliation': ''}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Hsu', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4324'] 1890,32559052,Cementless Versus Cemented Tibial Fixation in Posterior Stabilized Total Knee Replacement: A Randomized Trial.,"BACKGROUND Evidence supports the use of cementless tibial component fixation in total knee replacement but there is a paucity of literature on posterior stabilized designs. This randomized study of posterior stabilized total knee replacements compared cemented and cementless tibial fixation with regard to component migration, bone remodeling, and clinical outcomes. METHODS This prospective single-center, blinded, randomized clinical trial included 100 patients with a mean age of 68 years (range, 45 to 87 years). Operations were performed by either of 2 experienced arthroplasty surgeons using the Advanced Coated System (ACS) prosthesis (Implantcast). Patients were randomized to cemented or cementless tibial fixation; other variables were standardized. Radiostereometric analysis (RSA) and dual x-ray absorptiometry (DXA) were performed during the inpatient stay and at 3, 12, and 24 months to monitor tibial component migration and periprosthetic bone mineral density (BMD). Clinical scores including the Oxford Knee Score and Short Form-12 were assessed prior to surgery and during follow-up. RESULTS Late and continuing migration was found with cementless fixation. At 24 months, the mean subsidence was significantly greater for the cementless group (1.22 mm) compared with the cemented group (0.06 mm) (p < 0.01). The mean maximum total point motion at 24 months was 2.04 mm for the cementless group and 0.48 mm for the cemented group (p < 0.01). The cemented group had more BMD loss than the cementless group in the medial, lateral, and anterior periprosthetic regions. Two tibial components were revised in the cementless group, including 1 for loosening. Clinical scores improved equally in the 2 groups. CONCLUSIONS Late ongoing subsidence and high maximum total point motion in our patients who underwent cementless tibial fixation raise concerns about the fixation stability of ACS cementless posterior stabilized knee replacements. Cemented tibial components were stable. Thus, we advise caution regarding the use of cementless tibial components and recommend tibial fixation with cement for the ACS posterior stabilized total knee replacement. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"The cemented group had more BMD loss than the cementless group in the medial, lateral, and anterior periprosthetic regions.","['ACS cementless posterior stabilized knee replacements', 'Posterior Stabilized Total Knee Replacement', '100 patients with a mean age of 68 years (range, 45 to 87 years']","['cementless tibial fixation', 'cementless tibial component fixation', 'Cementless Versus Cemented Tibial Fixation', 'cemented or cementless tibial fixation', 'Advanced Coated System (ACS) prosthesis (Implantcast', 'posterior stabilized total knee replacements compared cemented and cementless tibial fixation']","['BMD loss', 'Clinical scores including the Oxford Knee Score and Short Form-12', 'mean subsidence', 'Radiostereometric analysis (RSA) and dual x-ray absorptiometry (DXA', 'mean maximum total point motion', 'Clinical scores', 'periprosthetic bone mineral density (BMD']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449351', 'cui_str': 'Tibial component fixation'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",100.0,0.0541445,"The cemented group had more BMD loss than the cementless group in the medial, lateral, and anterior periprosthetic regions.","[{'ForeName': 'Nils Oscar', 'Initials': 'NO', 'LastName': 'Nivbrant', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Riaz J K', 'Initials': 'RJK', 'LastName': 'Khan', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Fick', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Haebich', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01010'] 1891,32559045,One-Year Outcomes of a Piscine Soft Tissue Alternative Used in Mucogingival Procedures: A Clinical Case Series.,"The free gingival graft (FGG) has been used predictably for gingival procedures aimed to increase the width of keratinized tissue (KT). Several soft tissue alternatives, such as xenografts and allografts, have been studied and proven to be successful with varying degrees. This pilot clinical case series evaluated the efficacy, safety, and initial clinical outcomes (measuring KT width) of a piscine xenograft material (Omega3 Wound, Kerecis) compared to the FGG (harvested from the patient palate) in correcting mucogingival deformities around teeth. A convenience sample of six subjects with unilateral or bilateral lack of KT were enrolled in the study. The primary objective of this pilot study was to determine the gain in width of KT. Secondary objectives included investigating the probing depth, recession depth, bleeding on probing, and inflammation score. There were three FGG sites and six xenograft sites. In bilateral-site treatments, FGG or piscine xenograft were randomly assigned. For unilateral sites, the piscine xenograft was used. Postoperatively, the patients returned for follow-up at 1, 2, 4, 12, 24, 48, and 52 weeks. All six subjects completed the 12-month study and reported uneventful healing. On average, the xenograft sites had a 3.25-mm gain in KT width, and the FGG had an average gain of 3.67 mm. This pilot clinical series showed the piscine xenograft to be safe and efficacious during healing and to increase the width of KT. Future studies may include a more robust study design with a greater number of subjects.",2020,The free gingival graft (FGG) has been used predictably for gingival procedures aimed to increase the width of keratinized tissue (KT).,['six subjects with unilateral or bilateral lack of KT were enrolled in the study'],['Piscine Soft Tissue Alternative Used in Mucogingival Procedures'],"['probing depth, recession depth, bleeding on probing, and inflammation score', 'uneventful healing', 'efficacy, safety, and initial clinical outcomes (measuring KT width) of a piscine xenograft material (Omega3 Wound, Kerecis', 'width of KT', 'gain in width of KT']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",6.0,0.032763,The free gingival graft (FGG) has been used predictably for gingival procedures aimed to increase the width of keratinized tissue (KT).,"[{'ForeName': 'Irina F', 'Initials': 'IF', 'LastName': 'Dragan', 'Affiliation': ''}, {'ForeName': 'A Alejandro', 'Initials': 'AA', 'LastName': 'Garcia H', 'Affiliation': ''}, {'ForeName': 'Raabia', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': ''}, {'ForeName': 'Nadeem Y', 'Initials': 'NY', 'LastName': 'Karimbux', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4165'] 1892,32559463,Dynamic trial fitting by an expanding trial cup does not jeopardize primary acetabular component stability.,"BACKGROUND Trial fitting of the acetabular component in uncemented total hip replacement is traditionally done by trial cups. Since trial cups do not resemble the real press-fit obtained by the definitive cup, a dynamic trial inserter, called the X-pander ®, was developed to mimic the real amount of press-fit. However, the concern is raised of losing the initial press-fit by using the X-pander® due to pre-expansion of the acetabulum. The purpose of this study was to assess if there is a difference in primary stability between both methods. METHODS A biomechanical randomized study was performed with bovine calf acetabula, with randomization between either using the X-pander® or the traditional trial cups to assess primary stability. The primary outcome was the force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up. FINDINGS In total, 54 cups (19 Anexys, 35 Trident) were inserted and tested after randomized trial fitting. Overall mean lever out was 45.1 Nm (SD 14.6) for the X-pander® group and 45.0 Nm (SD 14.5) for the trial cups group. After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77). INTERPRATION Initial press-fit of the implanted cup is not lost by pre-expansion as done with dynamic trial fitting with the X-pander®.",2020,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77). ",[],"['INTERPRATION', 'bovine calf acetabula']","['force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up']",[],"[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0000962', 'cui_str': 'Bone structure of acetabulum'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C1430904', 'cui_str': 'FOXM1 protein, human'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0542569', 'cui_str': 'newton'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]",54.0,0.260371,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77). ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hoornenborg', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.hoornenborg@xpertorthopedie.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Loon', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands; Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: justin.vanloon@amc.uva.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'de Waard', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: i.n.sierevelt@score-amsterdam.nl.'}, {'ForeName': 'K T M', 'Initials': 'KTM', 'LastName': 'Opdam', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: k.t.opdam@amc.uva.nl.'}, {'ForeName': 'G M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: g.m.kerkhoffs@amc.uva.nl.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.haverkamp@xpertorthopedie.nl.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105077'] 1893,32559474,"Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial.","BACKGROUND SGLT2 inhibition decreases albuminuria and reduces the risk of kidney disease progression in patients with type 2 diabetes. These benefits are unlikely to be mediated by improvements in glycaemic control alone. Therefore, we aimed to examine the kidney effects of the SGLT2 inhibitor dapagliflozin in patients with proteinuric kidney disease without diabetes. METHODS DIAMOND was a randomised, double-blind, placebo-controlled crossover trial done at six hospitals in Canada, Malaysia, and the Netherlands. Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade. Participants were randomly assigned (1:1) to receive placebo and then dapagliflozin 10 mg per day or vice versa. Each treatment period lasted 6 weeks with a 6-week washout period in between. Participants, investigators, and study personnel were masked to assignment throughout the trial and analysis. The primary outcome was percentage change from baseline in 24-h proteinuria during dapagliflozin treatment relative to placebo. Secondary outcomes were changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers. Analyses were done in accordance with the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT03190694. FINDINGS Between Nov 22, 2017, and April 5, 2019, 58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women) were randomly assigned (27 received dapagliflozin then placebo and 26 received placebo then dapagliflozin). One patient discontinued during the first treatment period. All patients were included in the analysis. Mean baseline mGFR was 58·3 mL/min per 1·73 m 2 (SD 23), median proteinuria was 1110 mg per 24 h (IQR 730-1560), and mean HbA 1c was 5·6% (SD 0·4). The difference in mean proteinuria change from baseline between dapagliflozin and placebo was 0·9% (95% CI -16·6 to 22·1; p=0·93). Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2 (-9·0 to -4·2; p<0·0001) at week 6. This reduction was fully reversible within 6 weeks after dapagliflozin discontinuation. Compared with placebo, bodyweight was reduced by 1·5 kg (0·03-3·0; p=0·046) with dapagliflozin; changes in systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers did not differ significantly between dapagliflozin and placebo treatment. The numbers of patients who had one or more adverse events during dapagliflozin treatment (17 [32%] of 53) and during placebo treatment (13 [25%] of 52) were similar. No hypoglycaemic events were reported and no deaths occurred. INTERPRETATION 6-week treatment with dapagliflozin did not affect proteinuria in patients with chronic kidney disease without diabetes, but did induce an acute and reversible decline in mGFR and a reduction in bodyweight. Long-term clinical trials are underway to determine whether SGLT2 inhibitors can safely reduce the rate of major clinical kidney outcomes in patients with chronic kidney disease with and without diabetes. FUNDING AstraZeneca.",2020,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2 (-9·0 to -4·2; p<0·0001) at week 6.","['Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade', '58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women', 'patients with chronic kidney disease with and without diabetes', 'Between Nov 22, 2017, and April 5, 2019', 'patients with proteinuric kidney disease without diabetes', 'patients with type 2 diabetes', 'non-diabetic patients with chronic kidney disease (DIAMOND', 'patients with chronic kidney disease without diabetes', 'six hospitals in Canada, Malaysia, and the Netherlands']","['dapagliflozin then placebo', 'dapagliflozin', 'SGLT2 inhibitors', 'placebo and then dapagliflozin 10 mg per day or vice versa', 'SGLT2 inhibitor dapagliflozin', 'placebo then dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers', 'median proteinuria', 'percentage change from baseline in 24-h proteinuria', 'mean proteinuria change', 'adverse events', 'hypoglycaemic events', 'changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers', 'Mean baseline mGFR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",58.0,0.624837,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2 (-9·0 to -4·2; p<0·0001) at week 6.","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Barbour', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cattran', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Abdul Gafor', 'Affiliation': 'Department of Medicine, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine, ZGT Hospital, Almelo and Hengelo, Netherlands.'}, {'ForeName': 'Soo Kun', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Reich', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Muh Geot', 'Initials': 'MG', 'LastName': 'Wong', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30162-5'] 1894,32559515,Fampridine-induced changes in walking kinetics are associated with clinical improvements in patients with multiple sclerosis.,"Gait dysfunction is common in patients with multiple sclerosis (PwMS). Treatment with prolonged-release fampridine (PR-fampridine) improves walking ability in some PwMS. Associated fampridine-induced changes in the walking pattern are still poorly understood but may provide a better understanding of the mechanisms underlying the beneficial drug effects. 61 PwMS were treated with PR-fampridine in a randomized, monocentric, double-blind and placebo-controlled clinical trial with crossover design (FAMPKIN). Drug-induced improvements in walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT) were quantified. In this sub-study of the FAMPKIN trial, fampridine-induced changes in kinetic gait patterns were analyzed by pressure-based foot print analysis during treadmill walking. Vertical ground reaction forces were analyzed during different gait phases. Kinetic data of 44 PwMS was eligible for analysis. During double-blind treatment with PR-fampridine, patients performed significantly better in the T25FW and 6MWT than during placebo treatment (p < 0.0001 for both). At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo. However, we found relevant changes of walking kinetics regarding forces during loading, single limb and pre-swing phase in a patient sub-group (n = 8). Interestingly, this sub-group demonstrated superior responsiveness to PR-fampridine in the clinical walking tests compared to those patients without any fampridine-induced changes in kinetics (n = 36). Our results demonstrate fampridine-induced changes in gait kinetics in a sub-group of PwMS. These gait pattern changes were accompanied by improved clinical walking performance under PR-fampridine. These results shed some light on the biomechanical changes in walking patterns underlying enhanced fampridine-induced gait performance.",2020,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","['patients with multiple sclerosis', 'patients with multiple sclerosis (PwMS']","['PR-fampridine', 'prolonged-release fampridine (PR-fampridine', 'placebo']","['clinical walking performance', 'Vertical ground reaction forces', 'walking kinetics', 'gait kinetics', 'Gait dysfunction', 'walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT', 'kinetic gait patterns', 'T25FW and 6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",61.0,0.124543,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lörincz', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sutter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Linnebank', 'Affiliation': 'Department of Neurology, University Witten/Herdecke and Evangelische Kliniken Gelsenkirchen, Munckelstraße 32, 45879 Gelsenkirchen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zörner', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Filli', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland; Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland; Swiss Center for clinical Movement Analysis (SCMA), Balgrist Campus AG, Lengghalde 5, 8008 Zurich, Switzerland. Electronic address: linard.filli@balgrist.ch.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116978'] 1895,32559601,Cardiovascular responses to pelvic floor muscle contraction in healthy women: Prospective study.,"OBJECTIVE Analyze the acute heart rate and blood pressure responses to two protocols of pelvic floor muscles contractions in premenopausal and postmenopausal women. METHODS Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal. The groups underwent two protocols and the pelvic floor muscle endurance, heart rate, and blood pressure values were monitored. Both protocols included 10 pelvic floor muscles contractions; one series contained contractions lasting 5 s with 5 s of rest between each contraction and the other series contained contractions lasting 10 s with 10 s of rest. RESULTS In both groups, there was a significant increase in the heart rate during pelvic floor muscles contractions (premenopausal: 71.0 ± 7.3 and 80.3 ± 7.7; postmenopausal: 65.4 ± 6.6 and 73.6 ± 6.6, at rest and contractions peak, respectively) and in systolic blood pressure immediately after the contractions. The observed values during exercise returned to basal values seconds after the contractions. A positive correlation between heart rate and vaginal squeeze pressure (r = 0.45, p = 0.0007 and r = 0.48, p = 0.0003, 5- and 10-s series, respectively) was observed. CONCLUSION The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.",2020,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"['premenopausal and postmenopausal women', 'healthy women', 'healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions', 'Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal']",['pelvic floor muscles contractions'],"['heart rate and blood pressure', 'pelvic floor muscle endurance, heart rate, and blood pressure values', 'heart rate', 'Cardiovascular responses', 'systolic blood pressure', 'heart rate and vaginal squeeze pressure']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",54.0,0.0281104,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"[{'ForeName': 'Alana Maria G', 'Initials': 'AMG', 'LastName': 'Bastos', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Soraia P', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Grasiela N', 'Initials': 'GN', 'LastName': 'Correia', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Perseguini', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil. Electronic address: pdriusso@ufscar.br.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.050'] 1896,32560069,Effects of a Physical Education Intervention on Academic Performance: A Cluster Randomised Controlled Trial.,"BACKGROUND We investigated the effects of three different interventions on academic performance in students enrolled in the first year of high school. METHODS This was a cluster randomised controlled trial conducted with 1200 students enrolled in the first year of high school. Schools were randomly assigned to: 1. Doubling physical education (PE) classes (3:20 h of PE/week); 2. workshop with the PE teachers; 3. workshop with the PE teachers and doubling the PE classes; and 4. control group (1:40 h of PE/week). We assured that the schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom. RESULTS Overall, the intervention was not effective in improving the students' academic performance. However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average). CONCLUSIONS Enhancing the pedagogical skills of the teachers is a promising approach in improving the academic performance of students who failed an academic year.",2020,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average). ","['1200 students enrolled in the first year of high school', 'students enrolled in the first year of high school', 'schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom', 'students who failed an academic year']","['workshop intervention', 'Physical Education Intervention']","[""students' academic performance"", 'academic performance', 'Doubling physical education (PE) classes', 'Academic Performance']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1200.0,0.0519151,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average). ","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sport Science, University of Graz, Mozartgasse 14, 8010 Graz, Austria.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bezerra', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Mauro Virgílio Gomes', 'Initials': 'MVG', 'LastName': 'de Barros', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17124287'] 1897,32560099,Temperament and Character Profile and Its Clinical Correlates in Male Patients with Dual Schizophrenia.,"Personality traits are relevant in understanding substance use disorders (SUD) and schizophrenia (SZ), but few works have also included patients with dual schizophrenia (SZ+) and personality traits. We explored personality profile in a sample of 165 male patients under treatment, using the Temperament and Character Inventory-Revised. The participants were assigned to three groups of 55 patients each, according to previous diagnosis: SUD, SZ- and SZ+ (without/with SUD). We analyzed their clinical characteristics, relating them to personality dimensions. The SUD and SZ+ groups scored higher than SZ- in Novelty/Sensation Seeking. SZ- and SZ+ presented higher Harm Avoidance and lower Persistence than the SUD group. SZ+ patients showed the lowest levels of Self-directedness, while SZ- and SZ+ had higher scores in Self-transcendence than the SUD group. Several clinical characteristics were associated with personality dimensions depending on diagnosis, and remarkably so for psychiatric symptoms in the SZ- and SZ+ groups. The three groups had a maladaptive personality profile compared to general population. Our results point to different profiles for SUD versus SZ, while both profiles appear combined in the SZ+ group, with extreme scores in some traits. Thus, considering personality endophenotypes in SZ+ could help in designing individualized interventions for this group.",2020,"SZ+ patients showed the lowest levels of Self-directedness, while SZ- and SZ+ had higher scores in Self-transcendence than the SUD group.","['patients with dual schizophrenia (SZ+) and personality traits', 'Male Patients with Dual Schizophrenia', '165 male patients under treatment, using the Temperament and Character Inventory-Revised', '55 patients each, according to previous diagnosis']","['SUD, SZ- and SZ', 'SZ', 'SZ- and SZ']","['maladaptive personality profile', 'lowest levels of Self-directedness', 'Self-transcendence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}]","[{'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",165.0,0.0165927,"SZ+ patients showed the lowest levels of Self-directedness, while SZ- and SZ+ had higher scores in Self-transcendence than the SUD group.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Río-Martínez', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Marquez-Arrico', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Prat', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Adan', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9061876'] 1898,32560125,"The Effect of Loving-Kindness Meditation on Flight Attendants' Spirituality, Mindfulness and Subjective Well-Being.","Background : This study investigated: (1) the effects of the loving-kindness meditation (LKM) on mindfulness, subjective well-being (SWB), and spirituality and (2) the relationships between mindfulness, spirituality, and SWB. Methods : 98 flight attendants from Xiamen Airlines in China were recruited and randomly assigned to the LKM training group ( n = 49) or the waiting control group ( n = 49). The LKM training group underwent an 8-week LKM training intervention, and the control group did not undergo intervention. The three main variables (SWB, mindfulness, and spirituality) were measured both before (pre-test) and after (post-test) the LKM training intervention. Results : In the experimental group, SWB and spirituality increased significantly. In the control group, no significant differences were observed for the three variables between the pre-test and post-test. Conclusions : Our results indicated that LKM may help to improve SWB and spirituality. However, the mechanisms which underlie the effects of the LKM on mindfulness, spirituality, SWB, and other psychological constructs require further elucidation.",2020,"In the control group, no significant differences were observed for the three variables between the pre-test and post-test. ",['Methods : 98 flight attendants from Xiamen Airlines in China'],"[' ', 'waiting control group', 'LKM', 'loving-kindness meditation (LKM', 'LKM training intervention, and the control group did not undergo intervention', 'LKM training', 'Loving-Kindness Meditation']","['mindfulness, subjective well-being (SWB), and spirituality and (2) the relationships between mindfulness, spirituality, and SWB', 'SWB and spirituality', 'variables (SWB, mindfulness, and spirituality']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0166254,"In the control group, no significant differences were observed for the three variables between the pre-test and post-test. ","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'College of Aviation, Hua Qiao University, Xiamen 361021, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Business and Management, Chang Gung University, Taoyuan 33302, Taiwan.'}, {'ForeName': 'Chia-Yi', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Chang Gung Memorial Hospital, Taipei 10507, Taiwan.'}, {'ForeName': 'Rung-Tai', 'Initials': 'RT', 'LastName': 'Lin', 'Affiliation': 'Graduate School of Creative Industry Design, National Taiwan University of Arts, New Taipei 22058, Taiwan.'}, {'ForeName': 'Wen-Ko', 'Initials': 'WK', 'LastName': 'Chiou', 'Affiliation': 'Department of Psychiatry, Chang Gung Memorial Hospital, Taipei 10507, Taiwan.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020174'] 1899,32560171,Long-Term Socioeconomic Impact of Informal Care Provided to Patients with Pacemakers: Remote vs. Conventional Monitoring.,"The impact of informal care immediately after pacemaker (PM) implantation has been well established; however, not much is known about its long-term effects. The present study compared personal characteristics, associated problems, workloads, time, and costs related to informal care provided to patients with PM under remote monitoring (RM) vs. conventional monitoring (CM) in the hospital, five years after implantation. The PONIENTE study was a controlled, non-randomized or masked clinical trial conducted with information obtained from the perspective of informal caregivers. Data were collected at 12 and 60 months after PM implantation. The patients in the study were assigned to two different groups: remote monitoring (RM) and conventional monitoring (CM). The ""Disability, personal autonomy, and dependency situations survey"" (EDAD) was administered to collect information on sociodemographic characteristics, time, care difficulties, health status, professional aspects, and impact on economic, family, or leisure aspects of the main caregivers providing care to patients with pacemakers. After five years, 55 patients completed the study (RM = 21; CM = 34). The average age was 63.14 years (SD = 14.90), 96% of them were women, and the most predominant marital status was married (72%). Informal caregivers lived in the homes of the patients in 70% of cases, and 88% indicated that they had to provide care six to seven days a week. The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant ( p = 0.35). This study found similar results in the two groups under study with respect to sociodemographic characteristics, workload, time, and problems associated with health, leisure and family members. The costs associated with care were higher in the CM group; however, these differences were not statistically significant.",2020,"The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant ( p = 0.35).","['The average age was 63.14 years (SD = 14.90), 96% of them were women, and the most predominant marital status was married (72', 'patients with pacemakers']","['remote monitoring (RM) and conventional monitoring (CM', 'Informal Care', 'PM under remote monitoring (RM) vs. conventional monitoring (CM', 'informal care immediately after pacemaker (PM) implantation']","['average cost per patient', 'personal characteristics, associated problems, workloads, time, and costs related to informal care', 'sociodemographic characteristics, time, care difficulties, health status, professional aspects, and impact on economic, family, or leisure aspects of the main caregivers providing care']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.0284831,"The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant ( p = 0.35).","[{'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Leal-Costa', 'Affiliation': 'Nursing Department, University of Murcia, 30003 Murcia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Villegas', 'Affiliation': 'Social Involvement of Critical and Emergency Medicine, CTS-609 Research Group, Hospital de Poniente, 04700 El Ejido-Almería, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catalan-Matamoros', 'Affiliation': 'Department of Journalism and Communication, Universidad Carlos III de Madrid, 28903 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Robles-Musso', 'Affiliation': 'Intensive Care Unit, Hospital de Poniente, 04700 El Ejido-Almería, Spain.'}, {'ForeName': 'Knut Tore', 'Initials': 'KT', 'LastName': 'Lappegård', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, 9019 Tromsø, Norway.'}, {'ForeName': 'Rafael Jesus', 'Initials': 'RJ', 'LastName': 'Bautista-Mesa', 'Affiliation': 'Management Unit, Hospital de Poniente, 04700 El Ejido-Almería, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Peiró', 'Affiliation': 'Health Services Research Unit, FISABIO-PUBLIC HEALTH, 46020 Valencia, Spain.'}, {'ForeName': 'Remedios', 'Initials': 'R', 'LastName': 'Lopez-Liria', 'Affiliation': 'Department of Nursing Science, Physiotherapy and Medicine, Hum-498 Research Team, Health Research Centre, University of Almería, 04120 El Ejido-Almería, Spain.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020175'] 1900,32560181,"Effects of L-Phenylalanine on Energy Intake and Glycaemia-Impacts on Appetite Perceptions, Gastrointestinal Hormones and Gastric Emptying in Healthy Males.","In humans, phenylalanine stimulates plasma cholecystokinin (CCK) and pyloric pressures, both of which are important in the regulation of energy intake and gastric emptying. Gastric emptying is a key determinant of postprandial blood glucose. We evaluated the effects of intragastric phenylalanine on appetite perceptions and subsequent energy intake, and the glycaemic response to, and gastric emptying of, a mixed-nutrient drink. The study consisted of two parts, each including 16 healthy, lean males (age: 23 ± 1 years). In each part, participants received on three separate occasions, in randomised, double-blind fashion, 5 g (Phe-5 g) or 10g ('Phe-10 g) L-phenylalanine, or control, intragastrically, 30 min before a standardised buffet-meal (part A), or a standardised mixed-nutrient drink (part B). In part A, plasma CCK and peptide-YY (PYY), and appetite perceptions, were measured at baseline, after phenylalanine alone, and following the buffet-meal, from which energy intake was assessed. In part B, plasma glucose, glucagon-like peptide-1 (GLP-1), insulin and glucagon were measured at baseline, after phenylalanine alone, and for 2 h following the drink. Gastric emptying of the drink was also measured by 13 C-acetate breath-test. Phe-10 g, but not Phe-5 g, stimulated plasma CCK ( p = 0.01) and suppressed energy intake ( p = 0.012); energy intake was correlated with stimulation of CCK (r = -0.4, p = 0.027), and tended to be associated with stimulation of PYY (r = -0.31, p = 0.082). Both Phe-10 g and Phe-5 g stimulated insulin and glucagon (all p < 0.05), but not GLP-1. Phe-10 g, but not Phe-5 g, reduced overall plasma glucose ( p = 0.043) and peak plasma glucose ( p = 0.017) in response to the mixed-nutrient drink. Phenylalanine had no effect on gastric emptying of the drink. In conclusion, our observations indicate that the energy intake-suppressant effect of phenylalanine is related to the stimulation of CCK and PYY, while the glucoregulatory effect may be independent of stimulation of plasma GLP-1 or slowing of gastric emptying.",2020,"g, but not Phe-5 g, stimulated plasma CCK ( p = 0.01) and suppressed energy intake ( p = 0.012)","['16 healthy, lean males (age: 23 ± 1 years', 'Healthy Males']","['Phenylalanine', 'intragastric phenylalanine', 'L-phenylalanine, or control', 'L-Phenylalanine', 'phenylalanine']","['overall plasma glucose', 'appetite perceptions and subsequent energy intake', 'Energy Intake and Glycaemia-Impacts on Appetite Perceptions, Gastrointestinal Hormones and Gastric Emptying', 'plasma CCK and peptide-YY (PYY), and appetite perceptions', 'plasma cholecystokinin (CCK) and pyloric pressures', 'stimulated plasma CCK', 'Gastric emptying', 'peak plasma glucose', 'plasma glucose, glucagon-like peptide-1 (GLP-1), insulin and glucagon', 'suppressed energy intake', 'gastric emptying']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]",,0.0579056,"g, but not Phe-5 g, stimulated plasma CCK ( p = 0.01) and suppressed energy intake ( p = 0.012)","[{'ForeName': 'Penelope C E', 'Initials': 'PCE', 'LastName': 'Fitzgerald', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Manoliu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Herbillon', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Steinert', 'Affiliation': 'Department of Surgery, Division of Visceral and Transplantation Surgery, University Hospital Zürich, 8091 Zürich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}]",Nutrients,['10.3390/nu12061788'] 1901,32560256,Gait Event Detection for Stroke Patients during Robot-Assisted Gait Training.,"Functional electrical stimulation and robot-assisted gait training are techniques which are used in a clinical routine to enhance the rehabilitation process of stroke patients. By combining these technologies, therapy effects could be further improved and the rehabilitation process can be supported. In order to combine these technologies, a novel algorithm was developed, which aims to extract gait events based on movement data recorded with inertial measurement units. In perspective, the extracted gait events can be used to trigger functional electrical stimulation during robot-assisted gait training. This approach offers the possibility of equipping a broad range of potential robot-assisted gait trainers with functional electrical stimulation. In particular, the aim of this study was to test the robustness of the previously developed algorithm in a clinical setting with patients who suffered a stroke. A total amount of N = 10 stroke patients participated in the study, with written consent. The patients were assigned to two different robot-assisted gait trainers (Lyra and Lokomat) according to their performance level, resulting in five recording sessions for each gait-trainer. A previously developed algorithm was applied and further optimized in order to extract the gait events. A mean detection rate across all patients of 95.8% ± 7.5% for the Lyra and 98.7% ± 2.6% for the Lokomat was achieved. The mean type 1 error across all patients was 1.0% ± 2.0% for the Lyra and 0.9% ± 2.3% for the Lokomat. As a result, the developed algorithm was robust against patient specific movements, and provided promising results for the further development of a technique that can detect gait events during robot-assisted gait training, with the future aim to trigger functional electrical stimulation.",2020,This approach offers the possibility of equipping a broad range of potential robot-assisted gait trainers with functional electrical stimulation.,"['A total amount of N = 10 stroke patients participated in the study, with written consent', 'stroke patients', 'Stroke Patients during Robot-Assisted Gait Training', 'patients who suffered a stroke']","['robot-assisted gait trainers (Lyra and Lokomat', 'Functional electrical stimulation and robot-assisted gait training']",['mean detection rate'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0228287', 'cui_str': 'Structure of hippocampal commissure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",10.0,0.0230811,This approach offers the possibility of equipping a broad range of potential robot-assisted gait trainers with functional electrical stimulation.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schicketmueller', 'Affiliation': 'HASOMED GmbH, Paul-Ecke-Str. 1, 39114 Magdeburg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Lamprecht', 'Affiliation': 'MEDIAN Neurological Rehabilitation Center Magdeburg, Gustav-Ricker-Str. 4, 39120 Magdeburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hofmann', 'Affiliation': 'HASOMED GmbH, Paul-Ecke-Str. 1, 39114 Magdeburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sailer', 'Affiliation': 'MEDIAN Neurological Rehabilitation Center Magdeburg, Gustav-Ricker-Str. 4, 39120 Magdeburg, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rose', 'Affiliation': 'Institute for Medical Engineering and Research Campus STIMULATE, University of Magdeburg, Universitaetsplatz 2, 39106 Magdeburg, Germany.'}]","Sensors (Basel, Switzerland)",['10.3390/s20123399'] 1902,32560436,"The Impact of Protein Supplementation on Exercise-Induced Muscle Damage, Soreness and Fatigue Following Prolonged Walking Exercise in Vital Older Adults: A Randomized Double-Blind Placebo-Controlled Trial.","BACKGROUND It is unknown whether protein supplementation can enhance recovery of exercise-induced muscle damage in older adults who have a disturbed muscle protein synthetic response. We assessed whether protein supplementation could attenuate exercise-induced muscle damage and soreness after prolonged moderate-intensity walking exercise in older adults. METHODS In a double-blind, placebo-controlled intervention study, 104 subjects (81% male, ≥65 years) used either a protein (n = 50) or placebo supplement (n = 54) during breakfast and directly after exercise. Within a walking event, study subjects walked 30/40/50 km per day on three consecutive days. Muscle soreness and fatigue were determined with a numeric rating scale, and creatine kinase (CK) concentrations and serum inflammation markers were obtained. RESULTS Habitual protein intake was comparable between the protein (0.92 ± 0.27 g/kg/d) and placebo group (0.97 ± 0.23 g/kg/d, p = 0.31). At baseline, comparable CK concentrations were found between the protein and the placebo group (110 (IQR: 84-160 U/L) and 115 (IQR: 91-186 U/L), respectively, p = 0.84). Prolonged walking (protein: 32 ± 9 km/d, placebo: 33 ± 6 km/d) resulted in a cumulative increase of CK in both the protein (∆283 (IQR: 182-662 U/L)) and placebo group (∆456 (IQR: 209-885 U/L)) after three days. CK elevations were not significantly different between groups ( p = 0.43). Similarly, no differences in inflammation markers, muscle soreness and fatigue were found between groups. CONCLUSIONS Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.",2020,"CONCLUSIONS Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.","['104 subjects (81% male, ≥65 years) used either a protein (n = 50) or', 'older adults', 'older adults who have a disturbed muscle protein synthetic response', 'Vital Older Adults']","['Protein supplementation', 'Placebo', 'protein supplementation', 'Prolonged Walking Exercise', 'Protein Supplementation', 'placebo supplement', 'placebo']","['CK elevations', 'CK concentrations', 'Muscle soreness and fatigue', 'cumulative increase of CK', 'numeric rating scale, and creatine kinase (CK) concentrations and serum inflammation markers', 'Habitual protein intake', 'Exercise-Induced Muscle Damage, Soreness and Fatigue', 'inflammation markers, muscle soreness and fatigue', 'muscle damage, muscle soreness or fatigue']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0442732', 'cui_str': 'Vital'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",104.0,0.447597,"CONCLUSIONS Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.","[{'ForeName': 'Dominique S M', 'Initials': 'DSM', 'LastName': 'Ten Haaf', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Coen C W G', 'Initials': 'CCWG', 'LastName': 'Bongers', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Hugo G', 'Initials': 'HG', 'LastName': 'Hulshof', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}]",Nutrients,['10.3390/nu12061806'] 1903,32560472,Repeated Menthol Mouth Swilling Affects Neither Strength nor Power Performance.,"This study aimed to assess the effects of repeated menthol mouth swilling upon strength and power performance. Nineteen (10 male) participants completed familiarisation and experimental trials of repeated menthol mouth swilling (0.1% concentration) or control (no swill) in a randomised crossover design. Participants performed an isometric mid-thigh pull (IMTP; peak and mean force; N), vertical jump (peak; cm) and six second sprint (peak and mean power; W) under each condition. Participants completed three efforts per exercise task interspersed with three-minute recoveries. Mean best values were analysed via a two-way mixed repeated measures ANOVA, and differences reported as effect sizes ± 95% confidence intervals, with accompanying descriptors and p values. Differences in peak IMTP values were unclear between familiarisation and experimental trials, and between menthol and control conditions. Mean IMTP force differed between familiarisation and control (0.51; -0.15 to 1.14; p = 0.001) and familiarisation and menthol conditions (0.50; -0.15 to 1.14; p = 0.002) by a small degree, but were unclear between control and menthol conditions. Unclear differences were also noted on vertical jump performance compared to familiarisation and between experimental conditions, with repeated six second peak and average power performance also showing unclear effects across all comparisons. We conclude that repeated menthol mouth swilling does not improve strength or power performance.",2020,"Mean IMTP force differed between familiarisation and control (0.51; -0.15 to 1.14; p = 0.001) and familiarisation and menthol conditions (0.50; -0.15 to 1.14; p = 0.002) by a small degree, but were unclear between control and menthol conditions.",['Nineteen (10 male) participants completed familiarisation and experimental trials of repeated'],['menthol mouth swilling (0.1% concentration) or control (no swill'],"['peak IMTP values', 'strength or power performance', 'vertical jump performance', 'strength and power performance', 'Strength nor Power Performance', 'Mean IMTP force']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",,0.128886,"Mean IMTP force differed between familiarisation and control (0.51; -0.15 to 1.14; p = 0.001) and familiarisation and menthol conditions (0.50; -0.15 to 1.14; p = 0.002) by a small degree, but were unclear between control and menthol conditions.","[{'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Best', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Temm', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hucker', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}, {'ForeName': 'Kerin', 'Initials': 'K', 'LastName': 'McDonald', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}]","Sports (Basel, Switzerland)",['10.3390/sports8060090'] 1904,32560485,Real-World Setting Cost-Effectiveness Analysis Comparing Three Therapeutic Schemes of One-Year Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer from the Cyprus NHS Payer Perspective.,"INTRODUCTION This study is one of the first real-world cost-effectiveness analyses of one-year adjuvant trastuzumab used in HER2-positive early female breast cancer in comparison to chemotherapy alone. It is just the second one in Europe, the first one in Cyprus, and the fourth one worldwide ever carried out using real-world data. METHODS Using a Markov model (four health states), a cost-effectiveness analysis was carried out both over 20 years and for a lifetime horizon. The sampling method used in this study was the randomized sampling of 900 women. RESULTS The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY]. For the lifetime horizon, with thresholds of €20,000, €40,000, and €60,000/QALY, all trastuzumab arms were found to be more cost-effective (ICER: €17,753.85/QALY). Moreover, for the 20-year and the lifetime horizons, with thresholds of €20,000/QALY, €40,000/QALY, and €60,000/QALY, the most cost-effective of the three subgroups (anthracyclines and then trastuzumab, no anthracyclines and then trastuzumab, and anthracyclines, taxanes, and trastuzumab) was that of anthracyclines and then trastuzumab (ICER: €18,301.55/QALY and €8954.97/QALY, respectively). CONCLUSIONS The study revealed that adjuvant trastuzumab for one year in female HER2-positive early breast cancer can be considered cost-effective.",2020,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","['HER2-positive early female breast cancer in comparison to chemotherapy alone', 'female HER2-positive early breast cancer', '900 women']","['Trastuzumab', 'adjuvant trastuzumab']","['quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY', 'cost-effective']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0166592,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","[{'ForeName': 'Savvas S', 'Initials': 'SS', 'LastName': 'Ioannou', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}, {'ForeName': 'Yiola', 'Initials': 'Y', 'LastName': 'Marcou', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kakouri', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Talias', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}]",International journal of environmental research and public health,['10.3390/ijerph17124339'] 1905,32560516,"Body Fat Changes and Liver Safety in Obese and Overweight Women Supplemented with Conjugated Linoleic Acid: A 12-Week Randomised, Double-Blind, Placebo-Controlled Trial.","Preliminary evidence suggests that conjugated linoleic acid (CLA) may reduce body weight and affect body composition. The present study assessed the effect of CLA supplementation on body fat composition in overweight and obese women, while also evaluating the liver safety of CLA use. Seventy-four obese or overweight women were randomly assigned to receive 3 g/day CLA or placebo for 12 weeks. Body composition (dual-energy X-ray absorptiometry) and liver function ( 13 C-methacetin breath test and serum liver enzymes) were assessed before and after the trial. Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p = 0.0007) and percentage ( p = 0.0006), android adipose tissue ( p = 0.0002), gynoid adipose tissue ( p = 0.0028), and visceral adipose tissue ( p = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p = 6.1 × 10 -11 ) when compared to those receiving a placebo. The maximum momentary 13C recovery changes and end-point values were significantly higher in the CLA group when compared to the placebo group ( p = 0.0385 and p = 0.0076, respectively). There were no significant changes in alanine aminotransferase, asparagine aminotransferase, and gamma-glutamyl transpeptidase activities between the groups. In conclusion, CLA supplementation was well tolerated and safe for the liver, which shows beneficial effects on fat composition in overweight and obese women.",2020,"Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p = 0.0007) and percentage ( p = 0.0006), android adipose tissue ( p = 0.0002), gynoid adipose tissue ( p = 0.0028), and visceral adipose tissue ( p = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p ","['Seventy-four obese or overweight women', 'overweight and obese women', 'Obese and Overweight Women Supplemented with']","['CLA supplementation', 'Placebo', 'conjugated linoleic acid (CLA', 'placebo', 'CLA or placebo', 'Conjugated Linoleic Acid', 'CLA']","['maximum momentary 13C recovery changes and end-point values', 'Body Fat Changes and Liver Safety', 'visceral adipose tissue', 'alanine aminotransferase, asparagine aminotransferase, and gamma-glutamyl transpeptidase activities', 'body fat composition', 'total body fat', 'tolerated and safe', 'Body composition (dual-energy X-ray absorptiometry) and liver function ( 13 C-methacetin breath test and serum liver enzymes', 'gynoid adipose tissue', 'android adipose tissue', 'lean body mass to height', 'body weight and affect body composition']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0074380', 'cui_str': 'Serine-glyoxylate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0066070', 'cui_str': 'methacetin'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",74.0,0.162104,"Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p = 0.0007) and percentage ( p = 0.0006), android adipose tissue ( p = 0.0002), gynoid adipose tissue ( p = 0.0028), and visceral adipose tissue ( p = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p ","[{'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Mądry', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Ida Judyta', 'Initials': 'IJ', 'LastName': 'Malesza', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Czochralska-Duszyńska', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Walkowiak', 'Affiliation': 'Division of Reproduction, Department of Gynecology and Obstetrics, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Miśkiewicz-Chotnicka', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': 'Department of Clinical Auxology and Pediatric Nursing, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}]",Nutrients,['10.3390/nu12061811'] 1906,32560526,The Application of Structural Retinal Biomarkers to Evaluate the Effect of Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant on Treatment of Diabetic Macular Edema.,"BACKGROUND The aim of this study was to compare the therapeutic effect of intravitreal treatment with ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers in patients with diabetic macular edema (DME). METHODS 156 treatment-naïve patients with DME were divided in two groups: 75 patients received 3 monthly intravitreal injections of ranibizumab 0.5 mg (Lucentis ® ) (Group 1) and 81 patients received an intravitreal implant of dexamethasone 0.7 mg (Ozurdex ® ) (Group 2). Patients were evaluated at baseline (V1), at three months post-treatment in Group 1, and at two months post-treatment in Group 2 (V2). Best-corrected visual acuity (BCVA) and swept source-OCT were recorded at each interval. Changes between V1 and V2 were analyzed using the Wilcoxon test and differences between the two groups of treatment were assessed using the Mann-Whitney test. Multiple regression analysis was performed to evaluate the possible OCT biomarker (CRT, ICR, CT, SND, HRS) as predictive factors for final visual acuity improvement. RESULTS In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed. A superiority of dexamethasone over ranibizumab in reducing the SDN height ( p -value = 0.03) and HRS ( p -value = 0.01) was documented. CONCLUSIONS Ranibizumab and dexamethasone are effective in the treatment of DME, as demonstrated by functional improvement and morphological biomarker change. DME associated with SDN and HRS represents a specific inflammatory pattern for which dexamethasone appears to be more effective.",2020,"In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed.","['156 treatment-naïve patients with DME', 'Diabetic Macular Edema', 'patients with diabetic macular edema (DME']","['DME', 'dexamethasone', 'ranibizumab 0.5 mg (Lucentis ® ', 'ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers', 'Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant', 'Ranibizumab and dexamethasone', 'ranibizumab', 'intravitreal implant of dexamethasone 0.7 mg (Ozurdex ® ']","['central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN', 'possible OCT biomarker (CRT, ICR, CT, SND, HRS', 'SDN height', 'BCVA', 'Best-corrected visual acuity (BCVA) and swept source-OCT']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C2702454', 'cui_str': 'Dexamethasone Drug Implant'}, {'cui': 'C1299681', 'cui_str': 'Intravitreal implant'}, {'cui': 'C2702453', 'cui_str': 'Dexamethasone 0.7 MG'}, {'cui': 'C2702456', 'cui_str': 'Ozurdex'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0520724', 'cui_str': 'Retinal cyst'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0038642', 'cui_str': 'Sudan'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0025925', 'cui_str': 'Mouse, Inbred ICR'}, {'cui': 'C0574347', 'cui_str': 'Sindhi language'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0449416', 'cui_str': 'Source'}]",156.0,0.03862,"In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed.","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Ceravolo', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Giovanni William', 'Initials': 'GW', 'LastName': 'Oliverio', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Bhatti', 'Affiliation': 'Glangwili General Hospital Carmarthen, Wales SA31 2AF, UK.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Trombetta', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rejdak', 'Affiliation': 'Department of General Ophthalmology and Pediatric Ophthalmology Service, Medical University of Lublin, 20079 Lublin, Poland.'}, {'ForeName': 'Mario Damiano', 'Initials': 'MD', 'LastName': 'Toro', 'Affiliation': 'Department of General Ophthalmology and Pediatric Ophthalmology Service, Medical University of Lublin, 20079 Lublin, Poland.'}, {'ForeName': 'Costantino John', 'Initials': 'CJ', 'LastName': 'Trombetta', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10060413'] 1907,32560544,Active Breaks: A Pilot and Feasibility Study to Evaluate the Effectiveness of Physical Activity Levels in a School Based Intervention in an Italian Primary School.,"Background: The school gives access to children, regardless of age, ethnicity, gender and socio-economic class and can be identified as the key environment in which to promote children's physical activity (PA). The guidelines of the European Union recommend accumulating at least 10-min bouts of PA to reach the daily 60 min. Active breaks (ABs) led by teachers inside the classroom represent a good strategy to promote PA. The aim of this pilot and feasibility study was to evaluate the feasibility and effectiveness in terms of PA level of an AB programme in children aged 8-9 years attending primary school. Methods: A pre-post quasi-experimental pilot and feasibility study was performed in two primary school classes, one of which was assigned to a 14-week AB intervention (AB group) and the other to the control group (CG). At baseline and at follow-up, children were monitored for sedentary and motor activity during an entire week using ActiGraph Accelerometer (ActiLife6 wGT3X-BT). The satisfaction of children and teachers was assessed by self-administered questionnaires. Results: In the pre-post comparison, AB group ( n = 16) showed a reduction in the minutes spent in weekly sedentary activity (-168.7 min, p > 0.05), an increase in the number of step counts (+14,026.9, p < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%. On the contrary, CG showed a worsening in all variables. ANCOVA analysis, after adjusting for baseline values, showed significant differences between the AB group and CG for time spent in MVPA, percentage of MVPA and step counts. The satisfaction of children and teachers was good. Teachers were able to adapt the AB protocol to the needs of the school curriculum, thus confirming the feasibility of the AB programme. Conclusions: This pilot and feasibility study showed the feasibility and effectiveness of the AB protocol and represented the basis for a future controlled trial.",2020,"p < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","['children aged 8-9 years attending primary school', 'Italian Primary School']",['AB programme'],"['number of step counts', 'minutes spent in weekly sedentary activity', 'Physical Activity Levels', 'feasibility and effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2.0,0.0270913,"p < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Masini', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Leoni', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lorusso', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via Selmi, 3, 40126 Bologna, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tessari', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna Viale Berti Pichat, 5, 40126 Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ceciliani', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17124351'] 1908,32560576,"Erratum: Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial; Nutrients 2020, 12 , 1165.",The authors would like to correct an error in a recent published paper [...].,2020,The authors would like to correct an error in a recent published paper [...].,['Pregnant Women with Gestational Diabetes'],['Erratum: Dietary Intervention'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]",[],,0.178666,The authors would like to correct an error in a recent published paper [...].,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Kusinski', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Cambridge Universities NHS Foundation Trust, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Emanuella De Lucia', 'Initials': 'EL', 'LastName': 'Rolfe', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Rennie', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Linda M Oude', 'Initials': 'LMO', 'LastName': 'Griep', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Cellular Medicine, University of Newcastle, NE4 5PL, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}]",Nutrients,['10.3390/nu12061793'] 1909,32560632,"Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases.","BACKGROUND In patients undergoing major liver resection, portal vein embolization (PVE) has been widely used to induce hypertrophy of the non-embolized liver in order to prevent post-hepatectomy liver failure. PVE is a safe and effective procedure, but does not always lead to sufficient hypertrophy of the future liver remnant (FLR). Hepatic vein(s) embolization has been proposed to improve FLR regeneration when insufficient after PVE. The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone. We have developed the so-called liver venous deprivation (LVD), a combination of PVE and HVE during the same intervention, to optimize the phase of liver preparation before surgery. The main objective of this randomized phase II trial is to compare the percentage of change in FLR volume at 3 weeks after LVD or PVE. METHODS Patients eligible to this multicenter prospective randomized phase II study are subjects aged from 18 years old suffering from colo-rectal liver metastases considered as resectable and with non-cirrhotic liver parenchyma. The primary objective is the percentage of change in FLR volume at 3 weeks after LVD or PVE using MRI or CT-Scan. Secondary objectives are assessment of tolerance, post-operative morbidity and mortality, post-hepatectomy liver failure, rate of non-respectability due to insufficient FLR or tumor progression, per-operative difficulties, blood loss, R0 resection rate, post-operative liver volume and overall survival. Objectives of translational research studies are evaluation of pre- and post-operative liver function and determination of biomarkers predictive of liver hypertrophy. Sixty-four patients will be included (randomization ratio 1:1) to detect a difference of 12% at 21 days in FLR volumes between PVE and LVD. DISCUSSION Adding HVE to PVE during the same procedure is an innovative and promising approach that may lead to a rapid and major increase in volume and function of the FLR, thereby increasing the rate of resectable patients and limiting the risk of patient's drop-out. TRIAL REGISTRATION This study was registered on clinicaltrials.gov on 15th February 2019 (NCT03841305).",2020,The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone.,"['patients undergoing major liver resection', 'colo-rectal liver metastases', 'Patients eligible to this multicenter prospective randomized phase II study are subjects aged from 18\u2009years old suffering from colo-rectal liver metastases considered as resectable and with non-cirrhotic liver parenchyma']","['sequential right hepatic vein embolization (HVE', 'simultaneous portal and hepatic vein embolization to portal vein embolization', 'PVE', 'portal vein embolization (PVE']","['percentage of change in FLR volume', 'FLR regeneration', 'FLR volume', 'assessment of tolerance, post-operative morbidity and mortality, post-hepatectomy liver failure, rate of non-respectability due to insufficient FLR or tumor progression, per-operative difficulties, blood loss, R0 resection rate, post-operative liver volume and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0736268', 'cui_str': 'Liver tissue'}]","[{'cui': 'C0226706', 'cui_str': 'Structure of right hepatic vein'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0019155', 'cui_str': 'Structure of hepatic vein'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0578122', 'cui_str': 'Embolization of portal vein'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",64.0,0.0556545,The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Deshayes', 'Affiliation': 'Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, University of Montpellier, Institut régional du Cancer de Montpellier (ICM), Montpellier, France.'}, {'ForeName': 'Lauranne', 'Initials': 'L', 'LastName': 'Piron', 'Affiliation': 'Department of Radiology, Saint Eloi University Hospital, 80 avenue Augustin Fliche, F-34295, Montpellier, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bouvier', 'Affiliation': 'Department of Radiology, Angers University Hospital, Angers, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lapuyade', 'Affiliation': 'Department of Radiology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Lermite', 'Affiliation': 'Department of Liver surgery, Angers University Hospital, Angers, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vervueren', 'Affiliation': 'Department of Nuclear Medicine, Angers University Hospital, Angers, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Department of Liver surgery, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Pinaquy', 'Affiliation': 'Department of Nuclear Medicine, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Chevallier', 'Affiliation': 'Department of Radiology, Nice University Hospital, Nice, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dohan', 'Affiliation': 'Department of Radiology, Assistance Publique - Hôpitaux de Paris, Cochin Hospital, Paris, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Rode', 'Affiliation': 'Department of Radiology, Croix Rousse Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sengel', 'Affiliation': 'Department of Radiology, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Guillot', 'Affiliation': 'Department of Radiology, Saint Eloi University Hospital, 80 avenue Augustin Fliche, F-34295, Montpellier, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Quenet', 'Affiliation': 'Department of Surgery, Institut régional du Cancer de Montpellier (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Guiu', 'Affiliation': 'Department of Radiology, Saint Eloi University Hospital, 80 avenue Augustin Fliche, F-34295, Montpellier, France. b-guiu@chu-montpellier.fr.'}]",BMC cancer,['10.1186/s12885-020-07065-z'] 1910,32560639,Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial.,"BACKGROUND It is not clear whether macular laser combined with anti-vascular endothelial growth factor (VEGF) can reduce the number of anti-VEGF injections in the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Our study aimed to investigate the effects of intravitreal ranibizumab with or without macular laser for ME secondary to BRVO and its associated number of anti-VEGF injections. METHODS This is a prospective, randomized, double-blind, monocentric trial.80 patients were enrolled and 64 patients fulfilled the study requirements. All patients received a minimum of 3 initial monthly ranibizumab injections, pro re nata (PRN) dosing thereafter VA and CRT stabilization criteria-driven PRN treatment. Laser was given 7 days after third ranibizumab injection in ranibizumab with laser group. The follow-up time of this study was 1 year. Best corrected visual acuity (BCVA) improvement, central retinal thickness (CRT) reduction and number of injections of patients were compared between two groups. T-test, non-parametric Wilcoxon test and chis-square tests were adopted for between-group comparisons. RESULTS Thirty patients received intravitreal ranibizumab 0.5 mg alone and 34 patients received intravitreal ranibizumab 0.5 mg with macular laser. At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001). However, there was no significant difference in BCVA improvement with baseline BCVA adjusted (p = 0.5226), and in the CRT reduction (P = 0.4552) between two groups after 52 weeks. There was also no significant difference in the number of injections between the two groups. (P = 0.0756). There was also no significant difference between ischemic and non-ischemic groups in BCVA improvement, CRT reduction and number of injections (P > 0.05). CONCLUSIONS Our study suggests that ranibizumab combined with macular laser is effective in the treatment of ME secondary to BRVO after 1 year of treatment with 3 + PRN regimen. However, combination of macular grid photocoagulation showed no beneficial anatomical or functional effect during follow-up period, nor did it reduce the number of ranibizumab injections, either in ischemic group or non-ischemic group. We suggest that there is no need to combine macular grid photocoagulation in the treatment of ME secondary to BRVO in the future. TRIAL REGISTRATION Clinical Trials NCT03054766. https://register.clinicaltrials.gov.Prospectively registered.",2020,"At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001).","['monocentric trial.80 patients were enrolled and 64 patients fulfilled the study requirements', 'macular edema secondary to branch retinal vein occlusion']","['macular grid photocoagulation', 'intravitreal ranibizumab 0.5\u2009mg with macular laser', 'ranibizumab', 'Ranibizumab with macular laser', 'ranibizumab injection in ranibizumab with laser group', 'ranibizumab injections, pro re nata (PRN', 'intravitreal ranibizumab', 'macular laser combined with anti-vascular endothelial growth factor (VEGF']","['BCVA improvement, CRT reduction and number of injections', 'BCVA improvement', 'BCVA increased significantly and CRT', 'Best corrected visual acuity (BCVA) improvement, central retinal thickness (CRT) reduction and number of injections', 'beneficial anatomical or functional effect', 'CRT reduction', 'number of injections', 'T-test, non-parametric Wilcoxon test and chis-square tests']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}]","[{'cui': 'C1302035', 'cui_str': 'Grid photocoagulation'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205120', 'cui_str': 'Square'}]",,0.264013,"At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001).","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. yuxiaobing1214@163.com.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaoya', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}]",BMC ophthalmology,['10.1186/s12886-020-01498-7'] 1911,32560681,Independent Housing and Support for non-homeless individuals with severe mental illness: randomised controlled trial vs. observational study - study protocol.,"BACKGROUND Social inclusion is essential for an adequate rehabilitation process for people with serious mental illness (SMI). Various supported housing settings aim to promote housing competencies and social inclusion in service users. Nevertheless, there is a strong preference in service users for independent living. We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland. METHODS This is a prospective multi-centre, four-arm, non-inferiority cohort study investigating the effectiveness and efficiency of IHS and RCS/TAU for people with SMI. Effectiveness will be measured by a standardised measure of social inclusion as primary outcome as well as by measures of functioning and well-being. Efficiency will be analysed on the basis of service usage and costs associated with the different housing settings. Participants will be consecutively recruited and subsequently enrolled between April 2019 and December 2020 and assessed at baseline and after six, twelve and after 24 months. At one study site, 56 participants will be randomly assigned to one of the conditions; the other study site will be conducted as an observational study investigating 112 admitted participants. DISCUSSION While the UN Convention of the Rights of People with Disabilities aims to promote the opportunity to choose one's place of residence, the limited supply of alternative forms of housing does not guarantee genuine freedom of choice. Increased diversification and flexibility of housing support is essential. If IHS shows non-inferiority in terms of their effectiveness and efficiency, users should be allowed to choose their kind of housing support. TRIAL REGISTRATION ClinicalTrials.gov: NCT03815604, December 04, 2019.",2020,"We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland. ","['Participants will be consecutively recruited and subsequently enrolled between April 2019 and December 2020 and assessed at baseline and after six, twelve and after 24\u2009months', 'service users', 'people with serious mental illness (SMI', 'non-homeless individuals with severe mental illness', 'two cities in Switzerland', 'people with SMI', '56 participants will be randomly assigned to one of the conditions; the other study site will be conducted as an observational study investigating 112 admitted participants']","['IHS and RCS/TAU', 'Housing and Support (IHS']",[],"[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],112.0,0.238054,"We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland. ","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adamus', 'Affiliation': 'Center for Psychiatric Rehabilitation, Universitäre Psychiatrische Dienste Bern (UPD), Murtenstrasse 46, CH-3008, Bern, Switzerland. christine.adamus@upd.unibe.ch.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Mötteli', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Jäger', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Richter', 'Affiliation': 'Center for Psychiatric Rehabilitation, Universitäre Psychiatrische Dienste Bern (UPD), Murtenstrasse 46, CH-3008, Bern, Switzerland.'}]",BMC psychiatry,['10.1186/s12888-020-02712-y'] 1912,32560689,The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes.,"BACKGROUND Personalised care and support planning (CSP) has been shown to improve diabetes outcomes, patient experience and provider morale in the care of persons living with diabetes. However, this has not been confirmed in controlled studies. Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore. METHODS Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study. Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation. This conversation is facilitated by a trained CSP practitioner who engages them in discussion of concerns, goals and action plans, and documents their plans for subsequent review. Participants in the two Control clinics will receive standard diabetes care. Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18 months of the study. The sample size is calculated at 1620 participants, with glycated haemoglobin (HbA1c) as the primary outcome measure. Secondary outcome measures include patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost. DISCUSSION This study is a pragmatic trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in a real world setting. It promises to provide insights with regard to the implementation of this model of care in Singapore and the region. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04288362. Retrospectively registered on 28 February 2020.",2020,"Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore. ","['Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation', 'persons living with diabetes in a real world setting', 'persons living with diabetes', 'persons living with diabetes in the public primary care setting in Singapore', 'Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18\u2009months of the study', 'Retrospectively registered on 28 February 2020', 'Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study']","['personalised care and support planning', 'personalised CSP', 'standard diabetes care', 'Personalised care and support planning (CSP']",['patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost'],"[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0727258,"Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore. ","[{'ForeName': 'Wee Hian', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore. wee_hian_tan@nuhs.edu.sg.'}, {'ForeName': 'Victor Weng Keong', 'Initials': 'VWK', 'LastName': 'Loh', 'Affiliation': 'Division of Family Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Venkataraman', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Shoon Thai', 'Initials': 'ST', 'LastName': 'Choong', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Yii Jen', 'Initials': 'YJ', 'LastName': 'Lew', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Sundram', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tsou', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Soon Guan', 'Initials': 'SG', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Gibbons', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Entwistle', 'Affiliation': 'Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Division of Family Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'E Shyong', 'Initials': 'ES', 'LastName': 'Tai', 'Affiliation': 'Division of Endocrinology, University Medicine Cluster, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Tong Wei', 'Initials': 'TW', 'LastName': 'Yew', 'Affiliation': 'Division of Endocrinology, University Medicine Cluster, National University Health System, Singapore, Singapore.'}]",BMC family practice,['10.1186/s12875-020-01173-2'] 1913,32560705,The psychometric properties of PHQ-4 anxiety and depression screening scale among out of school adolescent girls and young women in Tanzania: a cross-sectional study.,"BACKGROUND Literature suggests that most mental disorders have their onset in childhood and adolescence, but go undiagnosed until adulthood. Shorter versions of the screening tools such as the Patient Health Questionnaire with four items (PHQ-4) may help to improve screening coverage. This study assessed the psychometric properties of the PHQ-4 in screening for core symptoms of depression and anxiety among out of school adolescent girls and young women (AGYW). METHODS This is a cross-sectional analysis of data from a cluster randomized controlled trial conducted among AGYW between June and July 2018 in North-West Tanzania. Two thousand four hundred twenty-six out-of-school AGYW aged 15 to 23 years were included. Data were collected on tablets using audio computer-assisted self-interviews (ACASI). Cronbach's α was used to measure the reliability of the PHQ-4 while confirmatory factor analysis (CFA) and principal components analysis (PCA) were used for construct validity assessment. In CFA, three criteria were used to assess how well the model fits the data: Standardized Root Mean Square Residual (SRMR), the Comparative Fit Index (CFI), the Root Mean Square Error of Approximation (RMSEA) and 90% confidence interval for RMSEA. RESULTS Of the 2426 participants, 33.8 and 35.5% screened positive for core symptoms of anxiety (GAD-2 ≥ 3) and depression (PHQ-2 ≥ 3), respectively. Cronbach's α of the PHQ-4 was 0.81. Both items-correlation and corrected items-correlation of the PHQ-4 had total correlations above 0.5 (p < 0.01). CFA showed that all items loaded significantly onto the single factor, and loadings were strong, ranging from 0.67 to 0.77 (p < 0.01). CFA indicates that the PHQ-4 scale stand for a unidimensional construct with good model fit (CFI = 0.995, SRMR = 0.013, RMSEA = 0.054 and 90% CI for RMSEA (0.031-0.079)). PCA confirmed two distinct components; GAD-2 (anxiety) and PHQ-2 (depression). Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01). CONCLUSIONS The findings suggest that the PHQ-4 scale can reliably and validly screen for core symptoms of depression and anxiety among out of school AGYW. This tool is short and easy to administer. Thus, the PHQ-4 scale can be very useful in screening for anxiety and depression symptoms in the community, primary health facilities, research and programmatic settings.",2020,"Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01). ","['school adolescent girls and young women in Tanzania', 'school adolescent girls and young women (AGYW', 'AGYW between June and July 2018 in North-West Tanzania', 'Two thousand four hundred twenty-six out-of-school AGYW aged 15 to 23\u2009years were included']",['PHQ-4'],"['CFA', 'GAD-2 (anxiety) and PHQ-2 (depression', 'PHQ-4 anxiety and depression screening scale', 'Standardized Root Mean Square Residual (SRMR), the Comparative Fit Index (CFI), the Root Mean Square Error of Approximation (RMSEA', 'PHQ-2, GAD-2, and PHQ-4 screening items']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C5197676', 'cui_str': 'GAD-2'}, {'cui': 'C2706101', 'cui_str': 'PHQ-2'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",2426.0,0.0337356,"Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01). ","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Materu', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania. jacqueline.materu1989@gmail.com.'}, {'ForeName': 'Evodius', 'Initials': 'E', 'LastName': 'Kuringe', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nyato', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Galishi', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Amasha', 'Initials': 'A', 'LastName': 'Mwanamsangu', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maligo', 'Initials': 'M', 'LastName': 'Katebalila', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Shao', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Changalucha', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Soori', 'Initials': 'S', 'LastName': 'Nnko', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Mwita', 'Initials': 'M', 'LastName': 'Wambura', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}]",BMC psychiatry,['10.1186/s12888-020-02735-5'] 1914,32560714,On-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in Swiss office-workers (NEXpro): protocol for a cluster-randomized controlled trial.,"BACKGROUND Non-specific neck pain and headache are major economic and individual burden in office-workers. The aim of this study is to investigate the effect of a multi-component intervention combining workstation ergonomics, health promotion information group workshops, neck exercises, and an app to enhance intervention adherence to assess possible reductions in the economic and individual burden of prevalent and incident neck pain and headache in office workers. METHODS/DESIGN This study is a stepped wedge cluster-randomized controlled trial. Eligible participants will be any office-worker aged 18-65 years from two Swiss organisations in the Cantons of Zurich and Aargau, working more than 25 h a week in predominantly sedentary office work and without serious health conditions of the neck. One hundred twenty voluntary participants will be assigned to 15 clusters which, at randomly selected time steps, switch from the control to the intervention group. The intervention will last 12 weeks and comprises workstation ergonomics, health promotion information group workshops, neck exercises and an adherence app. The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire. Secondary outcomes are neck disability and pain (measured by the Neck Disability Index, and muscle strength and endurance measures), headache (measured by the short-form headache impact test), psychosocial outcomes (e.g. job-stress index, Fear-Avoidance Beliefs Questionnaire), workplace outcomes (e.g. workstation ergonomics), adherence to intervention, and additional measures (e.g. care-seeking). Measurements will take place at baseline, 4 months, 8 months, and 12 months after commencement. Data will be analysed on an intention to treat basis and per protocol. Primary and secondary outcomes will be examined using linear mixed-effects models. DISCUSSION To the authors' knowledge, this study is the first that investigates the impact of a multi-component intervention combining current evidence of effective interventions with an adherence app to assess the potential benefits on productivity, prevalent and incident neck pain, and headache. The outcomes will impact the individual, their workplace, as well as private and public policy by offering evidence for treatment and prevention of neck pain and headache in office-workers. TRIAL REGISTRATION ClinicalTrials.gov, NCT04169646. Registered 15 November 2019 - Retrospectively registered.",2020,"The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire.","['One hundred twenty voluntary participants', 'Registered 15 November 2019 - Retrospectively registered', 'Swiss office-workers (NEXpro', 'Eligible participants will be any office-worker aged 18-65\u2009years from two Swiss organisations in the Cantons of Zurich and Aargau, working more than 25\u2009h a week in predominantly sedentary office work and without serious health conditions of the neck']","['workstation ergonomics, health promotion information group workshops, neck exercises and an adherence app']","['neck disability and pain (measured by the Neck Disability Index, and muscle strength and endurance measures), headache (measured by the short-form headache impact test), psychosocial outcomes (e.g. job-stress index, Fear-Avoidance Beliefs Questionnaire), workplace outcomes (e.g. workstation ergonomics), adherence to intervention, and additional measures (e.g. care-seeking', 'health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire', 'productivity, prevalent and incident neck pain, and headache']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",120.0,0.182642,"The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Aegerter', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland. andrea.aegerter@zhaw.ch.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Deforth', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Venerina', 'Initials': 'V', 'LastName': 'Johnston', 'Affiliation': 'The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Queensland, Australia.'}, {'ForeName': 'Markus J', 'Initials': 'MJ', 'LastName': 'Ernst', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Volken', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Luomajoki', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Brunner', 'Affiliation': 'ZHAW School of Management and Law, Winterthur Institute of Health Economics, Gertrudstrasse 15, 8401, Winterthur, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dratva', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sjøgaard', 'Affiliation': 'University of Southern Denmark, Department of Sport Sciences and Clinical Biomechanics, Odense, Denmark.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Elfering', 'Affiliation': 'University of Bern, Institute of Psychology, Fabrikstrasse 8, 3012, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Melloh', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03388-x'] 1915,32560724,"Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study).","BACKGROUND The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus. METHODS In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model. RESULTS A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: - 1.38 ± 1.99 for saroglitazar 2 mg; - 1.47 ± 1.92 for saroglitazar 4 mg and - 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study. CONCLUSIONS Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients. Trial registration CTRI/2015/09/006203, dated 22/09/2015.",2020,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","['patients with type 2 diabetes mellitus', 'patients with T2DM [glycosylated hemoglobin (HbA1c)\u2009≥\u20097.5%] were enrolled from 39 sites in India', 'patients with type 2 diabetes (T2DM', 'A total of 1155 patients were enrolled in this study', 'T2DM patients']","['pioglitazone', 'saroglitazar or pioglitazone', 'saroglitazar 2\xa0mg and 4\xa0mg', 'saroglitazar']","['FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B', 'cardiovascular risk', 'TG, LDL-C, VLDL-C, TC and Non HDL-C', 'glycemic control, lipid profile and cardiovascular disease risk', 'glycemic control and lipid parameters', 'HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1155.0,0.113944,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","[{'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Krishnappa', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India. manjunath.k@zyduscadila.com.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Krupi', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Trivedi', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Nirali', 'Initials': 'N', 'LastName': 'Mody', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Khushboo', 'Initials': 'K', 'LastName': 'Faldu', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Maroo', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai, UAE.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01073-w'] 1916,32560734,"Efficacy and safety of Dingkun pill for female infertility patients with low prognosis undergoing in vitro fertilization-embryo transfer: study protocol for a multicenter, double-blind, randomized, placebo-controlled trial.","BACKGROUND Approximately 15% of couples in the reproductive age are affected by infertility. Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR) are required to undergo in vitro fertilization and embryo transfer (IVF-ET) to achieve pregnancy. However, studies indicate that poor response to gonadotropin stimulation has been reported in women undergoing IVF-ET. Results from two recent clinical studies in China suggest that traditional Chinese medicine (TCM) formula Dingkun pill (DKP) showed a curative effect by improving the clinical pregnancy rate in women with DOR and POR. However, the heterogeneity of the studies does not allow one to draw a definitive conclusion on the therapeutic effect of DKP. Therefore, the purpose of this study was to investigate the effect of DKP on improving the clinical outcome of pregnancy of IVF-ET in women with low prognosis. METHODS A multicenter, double-blinded, randomized placebo-controlled trial was conducted. A total of 460 infertile patients undergoing IVF or intracytoplasmic sperm injection (ICSI) were recruited from 12 public hospitals in China. Participants were randomly divided into the experimental group (DKP formula) or the placebo group (control) at a ratio of 1:1. All patients were treated with GnRH antagonist protocol and ovarian stimulation performed for 5 weeks (from the 5th day of the previous menstrual cycle to the day of oocyte retrieval). The patients were followed up for 6 months to record their conception outcome. The primary outcome is to compare the pregnancy outcome to those under placebo treatment. Secondary outcomes included the total count of the retrieved oocyte, embryo quality, endometrial thickness on ET day, implantation rate, and early miscarriage rate. DISCUSSION Currently, no multicenter, double-blind, randomized, placebo-controlled trials have been performed on the use of the DKP formula to improve on the clinical outcome of the conception of IVF-ET in women with low prognosis. DKP might provide a good clinical solution for females with low prognosis and undergoing IVF. There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis. Therefore, it is important to undertake a well-designed randomized trial to determine the effect of DKP in improving the clinical outcome of the conception of IVF-ET in women with low prognosis. TRIAL REGISTRATION Chinese Clinical Trial Registry (ChiCTR). TRIAL REGISTRATION NUMBER ChiCTR1900026614. Registered on 16 October 2019.",2020,There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis.,"['women with low prognosis', 'women undergoing IVF-ET', 'females with low prognosis and undergoing IVF', 'Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR', 'women with DOR and POR', '460 infertile patients undergoing IVF or intracytoplasmic sperm injection (ICSI) were recruited from 12 public hospitals in China', 'female infertility patients with low prognosis undergoing in vitro fertilization-embryo transfer']","['DKP', 'GnRH antagonist protocol and ovarian stimulation', 'Dingkun pill', 'traditional Chinese medicine (TCM) formula Dingkun pill (DKP', 'placebo']","['pregnancy outcome', 'clinical pregnancy rate', 'Efficacy and safety', 'total count of the retrieved oocyte, embryo quality, endometrial thickness on ET day, implantation rate, and early miscarriage rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C3839507', 'cui_str': 'Diminished ovarian reserve'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021361', 'cui_str': 'Female infertility'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4324508', 'cui_str': 'Early miscarriage'}]",460.0,0.653768,There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis.,"[{'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Science and Technology Department, Shandong University of Traditional Chinese Medicine, Jinan, 250300, China.'}, {'ForeName': 'Yanlin', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Medical Marketing Department, Shanxi Guangyuyuan Medicine Co., Ltd., Xian, 710003, China.'}, {'ForeName': 'Xianling', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.'}, {'ForeName': 'Zhengao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Reproductive and Genetic Center of Integrated Traditional and Western Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan City, 250011, Shandong Province, China. sunzhengao77@126.com.'}]",Trials,['10.1186/s13063-020-04502-z'] 1917,32560735,"Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial.","BACKGROUND Health disorders, due to the use of drugs with fiscalized substances, including controlled substances, have become a common problem in Colombia. Multiple reasons can help explain this problem, including self-medication, since access to these drugs may be easier. Also, there is a lack of knowledge that these drugs are safer than illicit drugs. The use of these drugs without a valid medical prescription and follow-up can have negative consequences such as drug abuse, addiction, and overdose, and eventually, have negative health consequences. Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy. For this reason, it is necessary to increase key competencies like knowledge, skills, and attitudes in the pharmacy staff of ambulatory (outpatients) pharmacies. METHODS This study is a prospective, cluster-randomized, parallel-group, multicenter trial of drugstores and drugstores/pharmacies (ambulatory pharmacies). The study is designed to determine the effectiveness of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in drugstores and drugstores/pharmacies. Pharmacy staff will be randomly selected and assigned to one of the study groups (intervention or control). The intervention group will receive a continuing education program for over 12 months. The control group will receive only general information about the correct use of complex dosage forms. The primary objective is to evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies (knowledge, skills, and attitudes) to improve the ambulatory (outpatient) pharmacy services: dispensation, health education, and pharmacovigilance of drugs with fiscalized substances. The secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program. DISCUSSION This clinical trial will establish whether providing a continuing education program for the adequate utilization of drugs with fiscalized substances improves pharmacy staff competencies regarding these drugs. TRIAL REGISTRATION ClinicalTrials.gov NCT03388567. Registered on 28 November 2017. First drugstore or drugstore/pharmacy randomized on December 1, 2018. PROTOCOL VERSION 0017102017MC.",2020,Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy.,"['drugstores and drugstores/pharmacies', 'drugstores and drugstores/pharmacies (ambulatory pharmacies', 'Colombia drugstores and drugstores/pharmacies']","['drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program', 'fiscalized substance dispensation, health education, and pharmacovigilance continuing education program', 'continuing education program']","['secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program', 'pharmacy staff competencies (knowledge, skills, and attitudes']","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178990', 'cui_str': 'Pharmacovigilance'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0432705,Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy.,"[{'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Ceballos', 'Affiliation': 'Research Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Salazar-Ospina', 'Affiliation': 'Research Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sabater-Hernández', 'Affiliation': 'Pharmaceutical Care Research Group, Faculty of Pharmacy, University of Granada, Granada, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Amariles', 'Affiliation': 'Research Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia. pedro.amariles@udea.edu.co.'}]",Trials,['10.1186/s13063-020-04481-1'] 1918,32560737,The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial.,"BACKGROUND The direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendon during total hip arthroplasty (THA). The objective of this study is to compare patient satisfaction, functional outcomes, accuracy of implant positioning, component stability, gait, cost-effectiveness, and complications in the DSA versus PA for THA. METHODS AND ANALYSIS This prospective double-blinded randomised control trial will include 80 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to THA using the PA (control group) or DSA (investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning, gait analysis on force plate treadmill, implant migration with radiosteriometric analysis, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether the DSA provides improved outcomes compared to the PA for THA. Evaluation of study outcomes in DSA and PA will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Fulham Research Ethics Committee, UK. The study is sponsored by University College London, UK. DISCUSSION This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in THA performed using the PA versus DSA. The findings of this study will provide an improved understanding of the differences in the PA versus DSA for THA with respect to patient satisfaction, functional outcomes, implant survivorship, gait, cost-effectiveness, and complications. TRIAL REGISTRATION ClinicalTrials.gov, NCT04191993. Registered on 10 December 2019.",2020,"BACKGROUND The direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendon during total hip arthroplasty (THA).","['University College London, UK', '80 patients with symptomatic hip osteoarthritis undergoing primary THA', 'total hip arthroplasty']","['PA (control group) or DSA', 'direct superior approach versus posterior approach', 'DSA', 'direct superior approach (DSA']","['patient satisfaction, functional outcomes, accuracy of implant positioning, component stability, gait, cost-effectiveness, and complications', 'patient satisfaction, functional outcomes, implant survivorship, gait, cost-effectiveness, and complications', 'postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning, gait analysis on force plate treadmill, implant migration with radiosteriometric analysis, cost-effectiveness, and complications']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205512', 'cui_str': 'Posterior approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",80.0,0.293301,"BACKGROUND The direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendon during total hip arthroplasty (THA).","[{'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Kayani', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK. babar.kayani@gmail.com.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Konan', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Tahmassebi', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Ayuob', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Fares S', 'Initials': 'FS', 'LastName': 'Haddad', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}]",Trials,['10.1186/s13063-020-04484-y'] 1919,32560739,Efficacy and safety of Zihua Wenfei granules in treatment of postinfectious cough (wind-cold invading lungs syndrome): study protocol for a randomized controlled trial.,"BACKGROUND Postinfectious cough usually develops and persists following respiratory tract infection. The protracted cough is embarrassing and troublesome and significantly impairs daily life. However, the optimal treatment available for this condition is still not known. This study aims to investigate the efficacy and safety of a new Chinese herbal prescription, Zihua Wenfei granule (ZHWFG), in treatment of postinfectious cough (wind-cold invading lungs syndrome). METHODS This study is a prospective, multi-center, randomized, double-blinded, parallel group, placebo-controlled trial. A total of 216 adult participants with postinfectious cough will be enrolled from six study centers across China. All participants are randomly allocated to one of three parallel treatment groups: (1) 15 g of active ZHWFG three times daily, (2) 10 g of active ZHWFG plus 5 g of ZHWFG-matched placebo three times daily, and (3) 15 g of ZHWFG-matched placebo three times daily. The treatment duration is 14 consecutive days. The primary outcomes are cough resolution rate and cough relief rate. Secondary outcomes include time to cough resolution, time to cough relief, change from baseline in cough symptom score, cough visual analog scale value, traditional Chinese medicine syndrome score at days 7 and 14, and change of CQLQ from baseline to post-treatment as well as adverse events. DISCUSSION This trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough. TRIAL REGISTRATION ChiCTR1900022078. Registered on 23 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36547.",2020,"This trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough. ","['216 adult participants with postinfectious cough will be enrolled from six study centers across China', 'postinfectious cough (wind-cold invading lungs syndrome']","['ZHWFG-matched placebo', 'ZHWFG', 'Zihua Wenfei granules', 'active ZHWFG three times daily, (2) 10\u2009g of active ZHWFG plus 5\u2009g of ZHWFG-matched placebo', 'new Chinese herbal prescription, Zihua Wenfei granule (ZHWFG', 'placebo']","['cough resolution rate and cough relief rate', 'efficacy and safety', 'Efficacy and safety', 'time to cough resolution, time to cough relief, change from baseline in cough symptom score, cough visual analog scale value, traditional Chinese medicine syndrome score at days 7 and 14, and change of CQLQ from baseline to post-treatment as well as adverse events']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",216.0,0.424958,"This trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough. ","[{'ForeName': 'Huanan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'She', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Mao', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China. doc_jhl@163.com.'}]",Trials,['10.1186/s13063-020-04487-9'] 1920,32560744,"AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial.","OBJECTIVES Phase I - To determine the optimal dose of each candidate (or combination of candidates) entered into the platform. Phase II - To determine the efficacy and safety of each candidate entered into the platform, compared to the current Standard of Care (SoC), and recommend whether it should be evaluated further in a later phase II & III platforms. TRIAL DESIGN AGILE-ACCORD is a Bayesian multicentre, multi-arm, multi-dose, multi-stage open-label, adaptive, seamless phase I/II randomised platform trial to determine the optimal dose, activity and safety of multiple candidate agents for the treatment of COVID-19. Designed as a master protocol with each candidate being evaluated within its own sub-protocol (Candidate Specific Trial (CST) protocol), randomising between candidate and SoC with 2:1 allocation in favour of the candidate (N.B the first candidate has gone through regulatory approval and is expected to open to recruitment early summer 2020). Each dose will be assessed for safety sequentially in cohorts of 6 patients. Once a phase II dose has been identified we will assess efficacy by seamlessly expanding into a larger cohort. PARTICIPANTS Patient populations can vary between CSTs, but the main eligibility criteria include adult patients (≥18 years) who have laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We will include both severe and mild-moderate patients defined as follows: Group A (severe disease) - patients with WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, non-invasive ventilation or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (hospitalised, ventilation and additional organ support); Group B (mild-moderate disease) - ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO 2 ) >94% RA. If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible. Participants will be recruited from England, North Ireland, Wales and Scotland. INTERVENTION AND COMPARATOR Comparator is the current standard of care (SoC), in some CSTs plus placebo. Candidates that prevent uncontrolled cytokine release, prevention of viral replication, and other anti-viral treatment strategies are at various stages of development for inclusion into AGILE-ACCORD. Other CSTs will be added over time. There is not a set limit on the number of CSTs we can include within the AGILE-ACCORD Master protocol and we will upload each CST into this publication as each opens to recruitment. MAIN OUTCOMES Phase I: Dose limiting toxicities using Common Terminology Criteria for Adverse Events v5 Grade ≥3 adverse events. Phase II: Agreed on a CST basis depending on mechanism of action of the candidate and patient population. But may include; time to clinical improvement of at least 2 points on the WHO 9-point category ordinal scale [measured up to 29 days from randomisation], progression of disease (oxygen saturation (SaO 2) <92%) or hospitalization or death, or change in time-weighted viral load [measured up to 29 days from randomisation]. RANDOMISATION Varies with CST, but default is 2:1 allocation in favour of the candidate to maximise early safety data. BLINDING (MASKING) For the safety phase open-label although for some CSTs may include placebo or SoC for the efficacy phase. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) Varies between CSTs. However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40. TRIAL STATUS Master protocol version number v5 07 May 2020, trial is in setup with full regulatory approval and utilises several digital technology solutions, including Medidata's Rave EDC [electronic data capture], RTSM for randomisation and patient eConsent on iPads via Rave Patient Cloud. The recruitment dates will vary between CSTs but at the time of writing no CSTs are yet open for recruitment. TRIAL REGISTRATION EudraCT 2020-001860-27 14 th March 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40. ","['27 14 th March 2020', 'Participants will be recruited from England, North Ireland, Wales and Scotland', 'Patient populations can vary between CSTs, but the main eligibility criteria include adult patients (≥18 years) who have laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'severe and mild-moderate patients defined as follows: Group A (severe disease) - patients with WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, non-invasive ventilation or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (hospitalised, ventilation and additional organ support); Group B (mild-moderate disease) - ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO 2 ) >94% RA', 'COVID-19', '2020-001860']","['EudraCT', 'placebo']","['WHO 9-point category ordinal scale', 'efficacy and safety', 'progression of disease (oxygen saturation (SaO 2) <92%) or hospitalization or death, or change in time-weighted viral load']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0445087', 'cui_str': 'Nasal prongs'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.176754,"However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40. ","[{'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'University of Southampton, Southampton, Hampshire, UK. G.O.Griffiths@soton.ac.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fitzgerald', 'Affiliation': 'Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University and University of Cambridge, Lancaster, Lancashire, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corkhill', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Ellice', 'Initials': 'E', 'LastName': 'Marwood', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Reynolds', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Ewings', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Condie', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wrixon', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norton', 'Affiliation': 'Medidata Solutions, London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Radford', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yeats', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Darby-Dowman', 'Affiliation': 'Cancer Research UK Centre for Drug Development, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Walker', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04473-1'] 1921,32560745,"Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES There is little information about Coronavirus Disease 2019 (COVID-19) management for critically ill patients. Most of these patients develop acute respiratory distress syndrome (ARDS) due to excessive inflammatory response and the ensuing cytokine storm. Anti-inflammatory drugs including corticosteroids can be used to effectively reduce the effect of this cytokine storm and lung damage. However, corticosteroids can have side effects, so simultaneous administration of immunoglobulin (IV-IG) and interferon-beta can help manage treatment using corticosteroids. Therefore, we designed a trial to test our hypothesis that early administration of dexamethasone in combination with IV-IG and interferon-beta can reduce the effect of the cytokine storm in critically ill patients COVID-19. TRIAL DESIGN A phase two multi-center randomized controlled trial (RCT) with three parallel arms (1:1:1 ratio). PARTICIPANTS They will be hospitalized patients with severe COVID-19 who have positive RT-PCR test and have blood oxygen saturation levels (SpO 2 ) less than 90% and respiratory rate higher than 24 per minute or have involvement of more than 50% of their lung when viewed using computed tomography (CT)-scan. The age range of patients will be 18-70 years old. EXCLUSION CRITERIA the need for intubation; allergy, intolerance, or contraindication to any study drug including dexamethasone, IV-IG, and interferon-beta; pregnancy or lactation; known HIV positive or active hepatitis B or C. The study will be conducted in several hospitals of the Golestan province, Iran. INTERVENTION AND COMPARATOR The study subjects will be randomly allocated to three treatment arms: two experimental groups (two arms: Intervention 1 and Intervention 2) and one Control Group, which will be matched for age and sex using frequency matching method. Each eligible patient in the control arm will receive the standard treatment for COVID-19 based on WHO guidelines and the Ministry of the Health and Medical Education (MOHME) of Iran. Each patient in the Intervention Group 1 will receive the standard treatment for COVID-19 and dexamethasone, at the first 24 hours' time of admission. The intervention begins with the administration of dexamethasone based on the SpO 2 levels. If the level of SpO 2 does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration. In Intervention Group 2, the administration of dexamethasone will be started within the first 24 hours' time of admission and will be continued for 48-72 hours and then the SpO 2 level will be checked. Then, if the level of SpO 2 has not improved after that time, IV-IG and interferon-beta will be prescribed as the same dosage as Group 1. If the percentages of the SpO 2 level are between 85 and 90/ 80 and 85/ 75 and 80/ less than 75, the dosages will be 4 mg every 12 hours/ 4 mg every 8 hours/ 8 mg every 12 hours/ 8 mg every 8 hours, respectively. According to the WHO recommendation, all participants will have the best available supportive care with full monitoring. MAIN OUTCOMES Primary: An increase in the SpO 2 level to reach more than 90% in each case, which will be assessed by the oximeter. Secondary: The duration of hospital stays; intubation status and the percentage of patients who are free of mechanical ventilation; the mortality rates during hospitalization and one month after the admission time. RANDOMISATION Participants will be allocated into either control or intervention groups with a 1:1:1 allocation ratio using a computer random number generator to generate a table of random numbers for simple randomization. BLINDING (MASKING) The project's principal investigator (PI) is unblinded. However, the PI will not analyse the data and interpret the results. An unblinded researcher (a pharmacist) will cover the drug's bottles with aluminium foil and prepare them interventions and control drugs in a syringe with a code so that patients are blinded. This person will have no patients contact. The staff and nurses, caring for the patients, will be unblinded for each study group due to the nature of this study. The staff that take outcome measurements will be blinded. The laboratory technicians will also be blinded as well as the statistical team. These study statisticians will have access to coded data and will analyse the data labelled as group X, group Y, and group Z. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The target sample size will be 105 critically ill COVID-19 patients, who will be allocated randomly to the three trial arms with 35 patients in each group. TRIAL STATUS Recruitment is ongoing. The study began on April 18 2020 and will be completed June 19 2020. This summary describes protocol version 1; April 2 2020. TRIAL REGISTRATION https://www.irct.ir/. Identifier: IRCT20120225009124N4 version 1; Registration date: April 2 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The full protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.",2020,"If the level of SpO 2 does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration.","['hospitalized patients with severe COVID-19 who have positive RT-PCR test and have blood oxygen saturation levels (SpO 2 ) less than 90% and respiratory rate higher than 24 per minute or have involvement of more than 50% of their lung when viewed using computed tomography (CT)-scan', 'critically ill patients', 'critically ill COVID-19 patients', '105 critically ill COVID-19 patients', 'critically ill patients COVID-19', 'The study began on April 18 2020 and will be completed June 19 2020', 'several hospitals of the Golestan province, Iran', 'patients develop acute respiratory distress syndrome (ARDS']","['standard treatment for COVID-19 based on WHO guidelines and the Ministry of the Health and Medical Education (MOHME) of Iran', 'dexamethasone, intravenous immunoglobulin, and interferon-beta', 'dexamethasone', 'corticosteroids', 'standard treatment for COVID-19 and dexamethasone']",['duration of hospital stays; intubation status and the percentage of patients who are free of mechanical ventilation; the mortality rates during hospitalization and one month after the admission time'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",105.0,0.199707,"If the level of SpO 2 does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration.","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Abdolahi', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Kaheh', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Roghieh', 'Initials': 'R', 'LastName': 'Golsha', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Khodabakhshi', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Khandashpoor', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Besharat', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran. s_besharat_gp@yahoo.com.'}, {'ForeName': 'Samane', 'Initials': 'S', 'LastName': 'Tavassoli', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Livani', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Sadegh Ali', 'Initials': 'SA', 'LastName': 'Azimi', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Gharib', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Peivandi', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Fazel', 'Affiliation': 'Cancer Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Hesamaddin', 'Initials': 'H', 'LastName': 'Shirzad-Aski', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran. shirzad.hessam1364@gmail.com.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Roshandel', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran. roshandel_md@yahoo.com.'}]",Trials,['10.1186/s13063-020-04499-5'] 1922,32560746,Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) may trigger severe pneumonia in coronavirus disease of 2019 (COVID-19) patients through release of damage-associated molecular patterns (DAMPs) and recruitment of neutrophils in the lungs. Activated neutrophils induce inflammation and severe alveolar injury by releasing neutrophil extracellular traps (NETs). The backbones of many DAMPs and NETs are made of extracellular, cell-free DNA decorated with highly toxic compounds such as elastase, myeloperoxidase and citrullinated histones. Dornase alfa is a FDA-approved recombinant human DNAse 1 for the treatment of cystic fibrosis, which cleaves extracellular DNA and may break up cell-free DNA, loosening sticky mucus in the distal airways and reducing NETs-induced toxicity on alveolar pneumocytes. The COVIDornase trial intends to define the impact of aerosolized intra-tracheal dornase alfa administration on the severity and progression of acute respiratory distress syndrome (ARDS) in COVID-19 patients. This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs. TRIAL DESIGN COVIDornase is a prospective, randomized, controlled, 2-arm (1:1 ratio), multicentric, open-label clinical trial. PARTICIPANTS The study will recruit mechanically ventilated patients hospitalized in the intensive care unit (ICU) in the recruiting centres (at the time of writing: The Rothschild foundation hospital in Paris, the Strasbourg university hospitals, and Metz-Thionville hospital) who have been diagnosed with COVID-19 and meet ARDS criteria. INCLUSION CRITERIA - Adult patient (age ≥ 18 years old); - Hospitalized in ICU; - With severe COVID-19 pneumonia and ARDS according to Berlin criteria (PaO 2 /FiO 2 < 300 and PEEP > 5 cmH 2 O); - Intubated for less than 8 days; - With an anticipated duration of mechanical ventilation > 48 hours; - Carrier of an arterial catheter; - For whom 4 PaO 2 /FiO 2 values over the preceding 24 hours are available; NON-INCLUSION CRITERIA: - Known hypersensitivity to dornase alfa or any of its excipients; - Pregnant or breastfeeding status; - Patient under legal protection. INTERVENTION AND COMPARATOR Intervention 1, Study group Dornase alfa (Pulmozyme®, Roche, Switzerland) will be administered by aerosol, at a dose of 2500 IU twice daily, 12 hours apart, for 7 consecutive days, using a vibrating mesh nebulizer (Aerogen Solo®, Aerogen, Ireland). The remainder of the management will be performed in accordance with good clinical practice, including mechanical ventilation (protective ventilation, PEEP > 5 cmH 2 O, tracheal balloon pressure check every 4 hours or automatic device, 30° head of the bed elevation, tidal volume 6-8mL/kg, plateau pressure < 30 cmH 2 O), neuromuscular blockers if necessary, prone position if PaO 2 /FiO 2 < 150, early enteral nutrition, glycemic control and a sedation protocol based on the RASS score. Intervention 2, Comparator Patients will receive usual care in accordance with good practice (as detailed above), without aerosols. MAIN OUTCOMES The primary outcome is the occurrence of at least one grade improvement between D 0 (inclusion) and D 7 in the ARDS scale severity (Berlin criteria). For instance from ""severe"" to ""moderate"" or from ""moderate"" to ""mild"". RANDOMISATION All consecutive patients meeting the inclusion criteria will be randomised 1:1 using an eCRF-based, computer-generated randomisation table, either to the dornase alfa arm or to the control arm. An interim analysis will be performed after inclusion of 20 patients. Inclusions may be stopped at the interim analysis per data safety and monitoring board (DSMB) advice, if statistical analyses conclude on the futility or efficacy of the intervention or by other DSMB decision. BLINDING (MASKING) The participants and caregivers will not be blinded to study group assignment. Those assessing the outcomes will be blinded to study group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) Fifty patients will be randomized to each group, 100 patients in total. TRIAL STATUS Protocol version number 2, April 29 th , 2020. Recruitment is ongoing. The trial started recruitment on the 21 st April 2020. We estimate recruitment will finish August 21 st 2020. TRIAL REGISTRATION The trial was registered in ClinicalTrials.gov on 21 April 2020, updated on 8 May 2020. Trial registration number is NCT04355364. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This Letter serves as a summary of the key elements of the full protocol.",2020,"This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs. ","[' Adult patient (age ≥ 18 years old); - Hospitalized in ICU; - With severe COVID-19 pneumonia and ARDS according to Berlin criteria (PaO 2 /FiO 2 < 300 and PEEP > 5 cmH 2 O', 'COVID-19 patients', 'Protocol version number 2, April 29 th , 2020', 'Fifty patients will be randomized to each group, 100 patients in total', 'mechanically ventilated patients hospitalized in the intensive care unit (ICU) in the recruiting centres (at the time of writing: The Rothschild foundation hospital in Paris, the Strasbourg university hospitals, and Metz-Thionville hospital) who have been diagnosed with COVID-19 and meet ARDS criteria', 'patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS', '21 April 2020, updated on 8 May 2020']","['aerosolized intra-tracheal dornase alfa administration', 'Dornase alfa (Pulmozyme®, Roche, Switzerland', 'Comparator Patients will receive usual care in accordance with good practice (as detailed above), without aerosols']","['occurrence of at least one grade improvement between D 0 (inclusion) and D 7 in the ARDS scale severity (Berlin criteria', 'Efficacy and safety', 'severity and progression of acute respiratory distress syndrome (ARDS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C1135662', 'cui_str': 'Dornase Alfa'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0251564', 'cui_str': 'Pulmozyme'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",50.0,0.257936,"This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs. ","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Desilles', 'Affiliation': 'Biological Resource Center, Interventional Neuroradiology Department, Rothschild Foundation Hospital, Paris, France. jpdesilles@for.paris.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gregoire', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Le Cossec', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mophawe', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Losser', 'Affiliation': ""CHRU Nancy, Pôle d'Anesthésie-Réanimation, 29 Avenue de Lattre de Tassigny, 54000, Nancy, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lambiotte', 'Affiliation': 'Service de Réanimation Polyvalente, Centre Hospitalier de Valenciennes, Avenue Désandrouin, 59322, Valenciennes, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Le Tacon', 'Affiliation': 'CHR Metz-Thionville-Site de Mercy, Service de Réanimation Polyvalente, 1 Allée du Château, 57350, Ars-Laquenexy, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cantier', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Engrand', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Trouiller', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pottecher', 'Affiliation': ""Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service d'Anesthésie-Réanimation Chirurgicale, 1 Avenue Molière, 67098, Strasbourg, France.""}]",Trials,['10.1186/s13063-020-04488-8'] 1923,32560872,The immediate effects of pelvic compression belt with a textured sacral pad on the sacroiliac function in pregnant women with lumbopelvic pain: A cross-over study.,"BACKGROUND Pelvic belt is being used to alleviate the symptoms of lumbopelvic pain. OBJECTIVE To investigate the immediate effects of a pelvic belt with a textured sacral pad in pregnant women with lumbopelvic pain. METHODS Twenty-eight pregnant women participated in a randomized crossover study. Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain. Outcomes were measured in three randomized conditions including no pelvic belt (control), with a pelvic belt, and while a sacral pad was used with the pelvic belt. Data were analyzed using a one-way repeated measures analysis of variance for each variable. RESULTS Improvements in all study outcomes have been shown with a pelvic belt compared with the control condition. The addition of a textured sacral pad to the pelvic belt improved all study outcomes compared with the pelvic belt: hip joint position sense (p < 0.001; 95% confidence interval:1.3to2.3), perceived effort (p = 0.003; 95% confidence interval: 0.35 to 1.86), and maximum flexion force (p < 0.001; 95% confidence interval:2.77to6.47) in the active straight leg raising. CONCLUSION Further improvements were noted with the addition of the textured pad for all outcome measures. This finding may inform new benefits in adding a textured sacral pad to pelvic compression belts.",2020,"Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain.","['pregnant women with lumbopelvic pain', 'Twenty-eight pregnant women participated', 'twenty-eight pregnant women with lumbopelvic pain']","['pelvic belt with a textured sacral pad', 'pelvic compression belt with a textured sacral pad']","['sacroiliac function', 'Hip joint position sense, maximum hip flexion force, and perceived effort', 'maximum flexion force']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0555898', 'cui_str': 'Sacroiliac'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",28.0,0.208761,"Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain.","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Delshad', 'Affiliation': 'Student Research Committee, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Zarean', 'Affiliation': 'Department of Obstetrics and Gynecology, Feto-maternal Medicine Unit, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Yeowell', 'Affiliation': 'Department of Health Professions, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Sadeghi-Demneh', 'Affiliation': 'Musculoskeletal Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: sadeghi@rehab.mui.ac.ir.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102170'] 1924,32560926,Accuracy of diagnostic judgments using ICD-11 vs. ICD-10 diagnostic guidelines for obsessive-compulsive and related disorders.,"BACKGROUND We report results of an internet-based field study evaluating the diagnostic guidelines for the newly introduced ICD-11 grouping of obsessive-compulsive and related disorders (OCRD). We examined accuracy of clinicians' diagnostic judgments applying draft ICD-11 as compared to the ICD-10 diagnostic guidelines to standardized case vignettes. METHODS 1,717 mental health professionals who are members of the World Health Organization's Global Clinical Practice Network completed the study in Chinese, English, French, Japanese, Russian or Spanish. Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes. RESULTS Participants using ICD-11 outperformed those using ICD-10 in correctly identifying newly introduced OCRD, although results were mixed for differentiating OCRD from disorders in other groupings largely due to clinicians having difficulty differentiating challenging presentations of OCD. Clinicians had difficulty applying a three-level insight qualifier, although the 'poor to absent' level assisted with differentiating OCRD from psychotic disorders. Brief training on the rationale for an OCRD grouping did not improve diagnostic accuracy suggesting sufficient detail of the proposed guidelines. LIMITATIONS Standardized case vignettes were manipulated to include specific characteristics; the degree of accuracy of clinicians' diagnostic judgments about these vignettes may not generalize to application in routine clinical practice. CONCLUSIONS Overall, use of the ICD-11 guidelines resulted in more accurate diagnosis of case vignettes compared to the ICD-10 guidelines, particularly in differentiating OCRD presentations from one another. Specific areas in which the ICD-11 guidelines did not perform as intended provided the basis for further revisions to the guidelines.",2020,"Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes. ","[""1,717 mental health professionals who are members of the World Health Organization's Global Clinical Practice Network completed the study in Chinese, English, French, Japanese, Russian or Spanish""]","['ICD-11 vs. ICD-10 diagnostic guidelines', 'ICD-11 or ICD-10 guidelines']",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C4704940', 'cui_str': 'ICD-11'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]",[],1717.0,0.0236793,"Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes. ","[{'ForeName': 'Cary S', 'Initials': 'CS', 'LastName': 'Kogan', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, 136 Jean-Jacques Lussier, Vanier Hall, Ottawa, ON K1N 6N5, Canada. Electronic address: ckogan@uottawa.ca.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'SAMRC Unit on Risk & Resilience in Mental Disorders, University of Cape Town Dept of Psychiatry & Neuroscience Institute, Groote Schuur Hospital, J-Block, Anzio Road, Observatory 7925, Cape Town, South Africa. Electronic address: dan.stein@uct.ac.za.'}, {'ForeName': 'Tahilia J', 'Initials': 'TJ', 'LastName': 'Rebello', 'Affiliation': 'Global Mental Health Program, Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, Mailman School of Public Health, 722 West 168th, Floor R2, R-233, New York, NY 10032, USA. Electronic address: Tahilia.Rebello@nyspi.columbia.edu.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Keeley', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin St, Box 842018, Richmond, VA 23284, USA. Electronic address: jwkeeley@vcu.edu.'}, {'ForeName': 'K Jacky', 'Initials': 'KJ', 'LastName': 'Chan', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, 136 Jean-Jacques Lussier, Vanier Hall, Ottawa, ON K1N 6N5, Canada. Electronic address: jacky.chan@uottawa.ca.'}, {'ForeName': 'Naomi A', 'Initials': 'NA', 'LastName': 'Fineberg', 'Affiliation': 'Highly Specialized Obsessive Compulsive and Related Disorders Service, Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Welwyn Garden City, UK; Postgraduate Medical School, University of Hertfordshire, Hatfield, UK; University of Cambridge School of Clinical Medicine, Cambridge, UK. Electronic address: naomi.fineberg@btinternet.com.'}, {'ForeName': 'Leonardo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': 'Institute of Psychiatry, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil; ""D\'Or\' Institute for Research and Education, Rio de Janeiro, RJ, Brazil; School of Psychological Sciences, Monash University, Melbourne, Australia. Electronic address: lfontenelle@gmail.com.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. Electronic address: jgrant4@bsd.uchicago.edu.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Neuropsychiatry, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya Hyogo, Japan. Electronic address: hisa1311@hyo-med.ac.jp.'}, {'ForeName': 'H Blair', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY, USA; Anxiety Disorders Clinic and the Center for OCD and Related Disorders, New York State Psychiatric Institute, New York, NY, USA. Electronic address: hbs1@columbia.edu.'}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': 'Department for Child and Adolescent Psychiatry, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: per.hove.thomsen@ps.rm.dk.'}, {'ForeName': 'Odile A', 'Initials': 'OA', 'LastName': 'van den Heuvel', 'Affiliation': 'Amsterdam University Medical Centers, Vrije Universiteit, Department of Psychiatry and Department of Anatomy & Neurosciences, Amsterdam Neuroscience, Amsterdam, the Netherlands. Electronic address: oa.vandenheuvel@amsterdamumc.nl.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Veale', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Center for Anxiety Disorders and Trauma, South London and Maudsley NHS Foundation Trust, London, UK. Electronic address: david.veale@kcl.ac.uk.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Grenier', 'Affiliation': ""Institut du Savoir Montfort - Hôpital Montfort and Université d'Ottawa, Ottawa, Ontario, Canada. Electronic address: jeangrenier@montfort.on.ca.""}, {'ForeName': 'Mayya', 'Initials': 'M', 'LastName': 'Kulygina', 'Affiliation': 'Alekseev Mental Health Clinic, No. 1, Education Centre, Moscow, Russian Federation. Electronic address: mkulygina@yandex.ru.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'National Study Coordinator for ICD-11 Field Studies, ICD-11 Committee, Japanese Society of Psychiatry and Neurology, Hongo-Yumicho Building, 2-38-4, Hongo, Bunkyo-ku, Tokyo 113-0033. Japan. Electronic address: c.matsumoto@outlook.jp.'}, {'ForeName': 'Tecelli', 'Initials': 'T', 'LastName': 'Domínguez-Martínez', 'Affiliation': 'Center for Research on Global Mental Health, Direction of Epidemiology and Psychosocial Research, National Institute of Psychiatry ""Ramón de la Fuente Muñiz"", Mexico City, Mexico. Electronic address: tecelli.dominguez@gmail.com.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Stona', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, 11 Mandalay Road, Singapore. Electronic address: anne.claire.s@gmail.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai 200030, PR China. Electronic address: wangzhen@smhc.org.cn.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 1051 Riverside Drive, New York, NY \xa010032, USA; Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland. Electronic address: gmr2142@cumc.columbia.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.103'] 1925,32560932,Vascular endothelial growth factor and pigment epithelial-derived factor in the peripheral response to ketamine.,"BACKGROUND Ketamine is a rapid-acting antidepressant but its mechanism remains unclear. Vascular endothelial growth factor growth factor (VEGF) has been reported in the antidepressant action of ketamine in rodents. VEGF and pigment epithelial-derived factor (PEDF) signalling are closely linked and both are dysregulated in depression. We explored the effect of a single infusion of ketamine, with midazolam as comparison, on peripheral whole blood mRNA levels of vascular endothelial growth factor A (VEGFA) and PEDF, and the VEGFA/PEDF ratio, in patients with depression. METHODS Twenty-five patients with depression were randomised to either ketamine (0.5 mg/kg) or midazolam (0.045 mg/kg) infusions over 40 min. Blood plasma samples were taken 1 h before the first infusion and 4 h after the infusion start. mRNA was extracted and qRT-PCR performed to analyse gene expression. RESULTS Single infusions of ketamine and midazolam both decreased depression scores (F(1,21) = 102.40, p < 0.000). There was a significant group × time interaction for VEGFA mRNA levels (F(1, 21) = 5.207, p = 0.029), with ketamine increasing VEGFA levels. There was no significant effect of either ketamine or midazolam on PEDF levels. There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005). LIMITATIONS Patients were on psychotropic medication and continued treatment as usual throughout the study. CONCLUSIONS These preliminary results support a role for VEGF in the action of ketamine and suggest a novel role for VEGF/PEDF in the molecular response to ketamine.",2020,"There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005). ","['patients with depression', 'Twenty-five patients with depression', 'Patients were on psychotropic medication and continued treatment as usual throughout the study']","['ketamine and midazolam', 'ketamine', 'Ketamine', 'midazolam']","['time interaction for VEGFA/PEDF mRNA ratio', 'time interaction for VEGFA mRNA levels', 'depression scores (F(1,21)\xa0', 'PEDF levels', 'peripheral whole blood mRNA levels of vascular endothelial growth factor A (VEGFA) and PEDF, and the VEGFA/PEDF ratio', 'VEGFA levels', 'Blood plasma samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C3874456', 'cui_str': 'On psychotropic medication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",25.0,0.0481452,"There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005). ","[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'McGrory', 'Affiliation': ""Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin 2, Ireland; Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Ryan', 'Affiliation': ""Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin 2, Ireland; Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Gallagher', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Declan M', 'Initials': 'DM', 'LastName': 'McLoughlin', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland. Electronic address: d.mcloughlin@tcd.ie.""}]",Journal of affective disorders,['10.1016/j.jad.2020.04.013'] 1926,32560938,Depression prevention in digital cognitive behavioral therapy for insomnia: Is rumination a mediator?,"Background There has been growing support for digital Cognitive Behavioral Therapy (dCBT-I) as a scalable intervention that both reduces insomnia and prevents depression. However, the mechanisms by which dCBT-I reduces and prevents depression is less clear. Methods This was a randomized controlled trial with two parallel arms: dCBT-I (N=358), or online sleep education as the control condition (N=300). Outcome variables were measured at pre-treatment, post-treatment, and one-year follow-up, and included the Insomnia Severity Index (ISI), the Quick Inventory of Depressive Symptomatology (QIDS-SR 16 ), and the Perseverative Thinking Questionnaire (PTQ). The analyses tested change in PTQ scores as a mediator for post-treatment insomnia, post-treatment depression, and incident depression at one-year follow-up. Results Reductions in rumination (PTQ) were significantly larger in the dCBT-I condition compared to control. Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition. Finally, reductions in rumination also significantly mediated the prevention of clinically significant depression via dCBT-I (proportional effect = 42%). Limitations Depression was measured with a validated self-report instrument instead of clinical interviews. Durability of results beyond one-year follow-up should also be tested in future research. Conclusions Results provide evidence that rumination is an important mechanism in how dCBT-I reduces and prevents depression.",2020,Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition.,['insomnia'],"['digital cognitive behavioral therapy', 'dCBT-I (N=358), or online sleep education']","['rumination (PTQ', 'rumination', 'PTQ scores', 'post-treatment insomnia severity', 'Insomnia Severity Index (ISI), the Quick Inventory of Depressive Symptomatology (QIDS-SR 16 ), and the Perseverative Thinking Questionnaire (PTQ', 'Limitations Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0526111,Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition.,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States. Electronic address: pcheng1@hfhs.org.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Andrea Cuamatzi', 'Initials': 'AC', 'LastName': 'Castelan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Nimalan', 'Initials': 'N', 'LastName': 'Murugan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.184'] 1927,32560956,Cognitive remediation for the treatment of neuropsychological disturbances in subjects with euthymic bipolar disorder: findings from a controlled study.,"INTRODUCTION Individuals with euthymic Bipolar Disorder (BD) can experience deteriorated cognitive functioning, with such deterioration being associated with functional impairment. Cognitive remediation (CR) is considered an effective add-on intervention for neuropsychological impairments, but relatively few CR controlled studies have been performed on BD. In the present study the efficacy of a CR intervention designed for the improvement of cognition and functioning in patients with euthymic BD was tested. METHODS Patients (n = 54) with euthymic BD were assigned to receive active (n = 27) or control (n = 27) intervention. The active intervention (i.e. the Cognitive Remediation in Integrated Treatment - CRIIT - protocol) was made of 20 individual sessions focused on the treatment of attention, memory and executive functioning through the COGPACK software; each session was integrated with psychoeducation and rehabilitation interventions implemented through a metacognitive approach aimed at ameliorating personal agency. RESULTS A significant (p ≤ 0.015) time x group interaction at repeated measures MANOVA was observed on Rey Auditory Verbal Learning Test, Rey Complex Figure Test, Wisconsin Card Sorting Test, Trail Making Test, Visual Search, Life Skills Profile, and Barratt Impulsiveness Scale. LIMITATIONS A single-blind approach was used. DISCUSSION The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions. This study adds to the evidence that CR improves neurocognition in BD, and suggests that CRIIT protocol represents an add-on intervention of potential relevance to increase cognition and functioning in BD euthymic patients.",2020,"The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions.","['Individuals with euthymic Bipolar Disorder (BD', 'subjects with euthymic bipolar disorder', 'Patients (n\xa0', 'patients with euthymic BD']","['Cognitive remediation (CR', 'euthymic BD', 'Cognitive remediation', 'CR intervention']","['Rey Auditory Verbal Learning Test, Rey Complex Figure Test, Wisconsin Card Sorting Test, Trail Making Test, Visual Search, Life Skills Profile, and Barratt Impulsiveness Scale', 'executive functions, attention, memory, functioning and impulsivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0589103', 'cui_str': 'Rey complex figure test'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]",54.0,0.0233267,"The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bernabei', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy; Department of Mental Health, ASL Roma 5, Colleferro, Rome, Italy. Electronic address: laura.bernabei@uniroma1.it.""}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Bersani', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy. Electronic address: francescosaverio.bersani@uniroma1.it.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Pompili', 'Affiliation': 'Department of Mental Health, ASL Roma 5, Colleferro, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Delle Chiaie', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Valente', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Corrado', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Vergnani', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferracuti', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Biondi', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': ""Coccanari de'Fornari"", 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}]",Journal of affective disorders,['10.1016/j.jad.2020.05.073'] 1928,32561087,CD133 + cell infusion in patients with colorectal liver metastases going to be submitted to a major liver resection (CELLCOL): A randomized open label clinical trial.,"BACKGROUND Treatment of liver metastases of colorectal carcinoma is surgical resection. However, only 10-15% of the patients in this context will be candidate for curative resection arising other 10-13% after response to neoadyuvant chemotherapy. In order to perform the liver metastases surgery, it is necessary to have a sufficient remnant liver volume (RLV) which allows maintaining an optimal liver function after resection. Studies on liver regeneration have determined that CD133 + stem cells are involved in liver hypertrophy developed after an hepatectomy with encouraging results. As presented in previous studies, CD133 + stem cells can be selected from peripheral blood after stimulation with G-CSF, being able to obtain a large number of them. We propose to treat patients who do not meet criteria for liver metastases surgery because of insufficient RLV (<40%) with CD133 + cells together with portal embolization, in order to achieve enough liver volume which avoids liver failure. METHODS /Design: The aim of this study is to evaluate the effectiveness of preoperative PVE plus the administration of CD133 + mobilized from peripheral blood with G-CSF compared to PVE only. SECONDARY AIMS ARE: to compare the grade of hypertrophy, speed and changes in liver function, anatomopathological study of hypertrophied liver, to determine the safety of the treatment and analysis of postoperative morbidity and surveillance. STUDY DESIGN Prospective randomized longitudinal phase IIb clinical trial, open, to evaluate the efficacy of portal embolization (PVE) together with the administration of CD133 + cells obtained from peripheral blood versus PVE alone, in patients with hepatic metastasis of colorectal carcinoma (CCRHM). DISCUSSION The number of CD133 + obtained from peripheral blood after G -CSF stimulation will be far greater than the number obtained with direct puncture of bone marrow. This will allow a greater intrahepatic infusion, which could have a direct impact on achieving a larger and quicker hypertrophy. Consequently, it will permit the treatment of a larger number of patients with an increase on their survival. TRIAL REGISTRATION ClinicalTrials.gov, ID NCT03803241.",2020,"STUDY DESIGN Prospective randomized longitudinal phase IIb clinical trial, open, to evaluate the efficacy of portal embolization (PVE) together with the administration of CD133 + cells obtained from peripheral blood versus PVE alone, in patients with hepatic metastasis of colorectal carcinoma (CCRHM). ","['patients with hepatic metastasis of colorectal carcinoma (CCRHM', 'patients who do not meet criteria for liver metastases surgery because of insufficient RLV (<40%) with CD133\xa0+\xa0cells together with portal embolization, in order to achieve enough liver volume which avoids liver failure', 'Design', 'patients with colorectal liver metastases going to be submitted to a major liver resection (CELLCOL']","['CD133 + cell infusion', 'portal embolization (PVE', 'CD133\xa0+\xa0cells obtained from peripheral blood versus PVE alone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",[],,0.0500979,"STUDY DESIGN Prospective randomized longitudinal phase IIb clinical trial, open, to evaluate the efficacy of portal embolization (PVE) together with the administration of CD133 + cells obtained from peripheral blood versus PVE alone, in patients with hepatic metastasis of colorectal carcinoma (CCRHM). ","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Garcia-Botella', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: sandragbotella@gmail.com.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sáez-Carlin', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: psaezcarlin@gmail.com.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Méndez', 'Affiliation': 'Department of Radiology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: ramiro.mendez@outlook.com.'}, {'ForeName': 'Maria Paz', 'Initials': 'MP', 'LastName': 'Martin', 'Affiliation': 'Department o Hematology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: mariapazmartin@gmail.com.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Department of Surgical Pathology, Hospital Clínico San Carlos, Madrid, Spain. Electronic address: luis.ortega@salud.madrid.org.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Méndez', 'Affiliation': 'Department of Radiology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: jvmendezmontero@hotmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'García-Paredes', 'Affiliation': 'Department of Oncology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: begarpa@hotmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Diez-Valladares', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: lidiez@hotmail.com.'}, {'ForeName': 'Antonio Jose', 'Initials': 'AJ', 'LastName': 'Torres', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: antoniojose.torres@salud.madrid.org.'}]",Surgical oncology,['10.1016/j.suronc.2019.10.005'] 1929,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069'] 1930,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA. METHODS The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity. DISCUSSION Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population. TRIAL REGISTRATION ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070'] 1931,32561591,Quality of clinicians' conversations with patients and families before and after implementation of the Serious Illness Care Program in a hospital setting: a retrospective chart review study.,"BACKGROUND Seriously ill patients in hospital have indicated that better communication with practitioners is vital for improving care. The aim of this study was to assess whether the quality of conversations about serious illness improved after implementation of the Serious Illness Care Program (SICP). METHODS In this retrospective chart review study, we evaluated patients who were admitted to a medical ward at Hamilton General Hospital, had a stay of at least 48 hours, and were at risk for a lengthy stay or increased need for community-based services (inter-RAI Emergency Department Screener score of 5 or 6). The SICP study period was from Mar. 1, 2017, to Jan. 19, 2018. We used a validated codebook to assess the quality of documented conversations regarding serious illness for eligible patients before (usual care [control group]) and after SICP implementation (intervention group), specifically examining the following domains: patients' values and goals, understanding of prognosis and illness, end-of-life care planning, and code status or desire for other life-sustaining treatments. RESULTS The study sample included 56 patients in the control group and 56 patients in the intervention group. The overall quality of documented conversations about serious illness was significantly higher in the intervention group than in the control group ( p < 0.001) and was significantly higher in the subdomains of values and goals ( p < 0.001), understanding of prognosis and illness ( p < 0.001) and life-sustaining treatments ( p = 0.03) but not end-of-life care planning ( p = 0.48). INTERPRETATION Implementation of the SICP in a hospital setting was associated with higher quality of documented conversations regarding serious illness with patients at high risk for clinical or functional deterioration. The SICP is transferable and adaptable to a hospital setting, and was associated with an increase in adherence to best practices compared to usual care.",2020,"The overall quality of documented conversations about serious illness was significantly higher in the intervention group than in the control group ( p < 0.001) and was significantly higher in the subdomains of values and goals ( p < 0.001), understanding of prognosis and illness ( p < 0.001) and life-sustaining treatments ( p = 0.03) but not end-of-life care planning ( p = 0.48). ","['56 patients in the control group and 56 patients in the intervention group', 'patients who were admitted to a medical ward at Hamilton General Hospital, had a stay of at least 48 hours, and were at risk for a lengthy stay or increased need for community-based services (inter-RAI Emergency Department Screener score of 5 or 6', 'eligible patients before (usual care [control group]) and after']",['SICP implementation (intervention group'],"['understanding of prognosis and illness', 'quality of conversations about serious illness', 'overall quality of documented conversations about serious illness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C3178806', 'cui_str': 'Right Atrial Isomerism'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]",56.0,0.0641132,"The overall quality of documented conversations about serious illness was significantly higher in the intervention group than in the control group ( p < 0.001) and was significantly higher in the subdomains of values and goals ( p < 0.001), understanding of prognosis and illness ( p < 0.001) and life-sustaining treatments ( p = 0.03) but not end-of-life care planning ( p = 0.48). ","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Riehm', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'You', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont. John.You@thp.ca.""}]",CMAJ open,['10.9778/cmajo.20190193'] 1932,32561824,Semaphorin 3 C is a Novel Adipokine Representing Exercise-Induced Improvements of Metabolism in Metabolically Healthy Obese Young Males.,"This study investigated the endurance exercise-induced changes in lesser known adipokines (visfatin, chemerin, apelin, semaphorin 3 C) related to obesity and metabolism, and their correlations with the changes in the parameters of obesity and glucose homeostasis. Forty metabolically healthy obese young males were randomly assigned to control group (C, n = 12) or exercise group (Ex, n = 28). The subjects in Ex participated in a 8-week supervised endurance exercise training program, comprised of four sessions of treadmill running at 65-70% of VO 2max per week. Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex. At baseline, apelin and semaphorin 3 C appeared to be correlated with obesity measures, including body mass index, % total fat and trunk fat, and waist circumference. Exercise-induced changes in these obesity measures significantly correlated with the changes in chemerin and semaphorin 3 C. Basal chemerin, apelin and semaphorin 3 C correlated with glucose homeostasis parameters, including fasting plasma glucose, fasting plasma insulin, homeostasis model assessment of insulin resistance and β-cell function, and quantitative insulin-sensitivity check index to different extents. Furthermore, the changes in apelin and semaphorin 3 C well predicted the improvements in glycemic parameters. We suggest that semaphorin 3 C is a novel adipokine involved in pathophysiology of obesity and metabolism, and that it is a biomarker representing an exercise-induced improvement in metabolically healthy obese young males.",2020,"Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex.","['Metabolically Healthy Obese Young Males', 'Forty metabolically healthy obese young males', 'metabolically healthy obese young males']","['supervised endurance exercise training program', 'control group (C, n\u2009=\u200912) or exercise']","['glycemic parameters', 'fasting plasma glucose, fasting plasma insulin, homeostasis model assessment of insulin resistance and β-cell function, and quantitative insulin-sensitivity check index', 'Serum levels of visfatin, chemerin, apelin, and semaphorin 3\u2009C', 'body mass index, % total fat and trunk fat, and waist circumference']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0068707', 'cui_str': 'Nicotinamide phosphoribosyltransferase'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}, {'cui': 'C1136368', 'cui_str': 'Semaphorin-3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",40.0,0.0146105,"Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex.","[{'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Graduate School of Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yu Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, Yonsei University College of Medicine, Seoul, Korea. cromoton@yuhs.ac.'}]",Scientific reports,['10.1038/s41598-020-67004-7'] 1933,32561877,Effect of 9-month Pilates program on sagittal spinal curvatures and hamstring extensibility in adolescents: randomised controlled trial.,"The percentage of spine misalignment increases during the childhood and adolescence stages. The Pilates method has been associated with an improvement in the sagittal spine disposition, but no studies have been conducted on adolescents. Therefore, the present study aimed to evaluate the effectiveness of a 9-month Pilates exercise program (PEP) on hamstring extensibility and sagittal spinal curvatures on adolescents. This randomised controlled trial included 236 adolescents. The experimental group (EG) received a PEP (9 months, 2 sessions/week, 15 minutes/session). The control group (CG) did not receive any intervention. Hamstring extensibility was measured with the passive and active straight leg raise and toe-touch tests. Sagittal spinal curvatures and pelvic tilt was assessed in relaxed standing, active alignment and toe-touch test positions. The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature. The CG became significantly worse in thoracic kyphosis in standing. This study provides evidence of nine-months of a PEP increased the hamstring extensibility; averted the increase of the thoracic curvature, and decreased the curvature of the lumbar lordosis and pelvic tilt in standing position; avoided a greater increase of thoracic curvature in active alignment in standing position; and avoided the increase of thoracic curvature in trunk flexion.",2020,"The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature.","['hamstring extensibility and sagittal spinal curvatures on adolescents', '236 adolescents', 'adolescents']","['PEP', 'Pilates program', 'Pilates exercise program (PEP']","['Sagittal spinal curvatures and pelvic tilt', 'percentage of spine misalignment', 'Hamstring extensibility', 'hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature', 'thoracic curvature', 'hamstring extensibility', 'sagittal spinal curvatures and hamstring extensibility']","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]",236.0,0.0207577,"The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature.","[{'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'González-Gálvez', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Pablo Jorge', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain. pmarcos@ucam.edu.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Trejo-Alfaro', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Vaquero-Cristóbal', 'Affiliation': 'Research Group on Prevention of Lesions in Sports, Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}]",Scientific reports,['10.1038/s41598-020-66641-2'] 1934,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol. MATERIALS AND METHODS We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model. RESULTS The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving. CONCLUSIONS Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028'] 1935,32535263,Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial.,"BACKGROUND Postoperative cognitive dysfunction (POCD) is a complication of central nervous system in patients after surgery. Edaravone as a brain-protective agent may have protective effect on postoperative cognitive function. The study was designed to explore the effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery and potential mechanism. PATIENTS AND METHODS Patients undergoing hip joint replacement surgery were randomly allocated into 2 groups: the edaravone group (group E) and the control group (group C). Group E received intravenous edaravone at a dose of 0.5 mg/kg after induction of anesthesia, while group C received normal saline. The cognitive function was evaluated with the Mini-Mental State Examination (MMSE) 1day before surgery,3 days and the 7 days after surgery. Patients' plasma samples were collected to detect the levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA) before the induction of anesthesia, at the end of surgery and on postoperative day 3. RESULTS The MMSE scores in group E were higher than those of group C 3 days after surgery (25.98 ± 1.99 vs 24.86 ± 1.86, p = 0.003). There were remarkable rises (p < 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p < 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03 ± 2.46U/ml vs. 13.65 ± 2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01 ± 2.37 nmol/ml vs. 11.34 ± 3.18 nmol/ml, p = 0.0001). CONCLUSION The results indicated that preoperative intervention with edaravone may improve the postoperative cognitive function in elderly patients undergoing hip joint replacement surgery.",2020,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001). ","['eldely patients undergoing hip joint replacement surgery and potential mechanism', 'Patients undergoing hip joint replacement surgery', 'patients after surgery', 'elderly patients undergoing hip joint replacement surgery']","['intravenous edaravone', 'normal saline', 'edaravone', 'Edaravone']","['MDA level', 'MMSE scores', 'cognitive function', 'SOD concentration', 'levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA', 'postoperative cognitive function', 'plasma IL-6, S100βand MMP-9 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.097904,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001). ","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China. Electronic address: sun_long2@163.com.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China.'}, {'ForeName': 'Yang-Liang', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: nange1984@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.092'] 1936,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate. OBJECTIVE This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game. PARTICIPANTS AND SETTING The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia. METHOD All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34). RESULTS Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not. CONCLUSIONS This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569'] 1937,32535341,Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study.,"BACKGROUND People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain due to lie supine for at least 4 hours to avoid bleeding and hematoma. Body positioning is an effective and safe method for decreasing back pain in people with transfemoral cardiac catheterization; however, its effects and safety among patients with high bleeding tendency are unknown. OBJECTIVE To investigate whether body positioning could decrease back pain without increasing the chance of bleeding after transcatheter arterial chemoembolization. DESIGN A single-blind randomized controlled trial (ClinicalTrials.gov No.: NCT03784469). METHODS A total of 78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled. Each person was randomly assigned to either the control or intervention group (each consisted of 39 participants). The control group received the usual care, remaining flat and lying in a supine position, whereas the intervention group had their positions changed in the second and fourth hour after chemoembolization. Participants' pain level was rated by using numerical rating scale -11 (score from 0 to 10), bleeding was measured by using volume of blood (cc.) in gauze and hematoma size in diameter (cm), and satisfaction was self-rated from 1 to 5. Repeated-measure analysis of variance (ANOVA) was used to compare the difference in pain levels over time within each group and independent t test to compare the mean difference of pain between groups at 5 endpoints, both methods with Bonferroni adjustment. Independent t test, chi-squared test, and Fisher's exact test compared postembolization discomfort, puncture sites bleeding, satisfaction between groups. RESULTS Significant changes of pain levels over time in both intervention [F(2.93, 111.20)=7.64, p<.001] and control groups [F(2.66, 101.17)=20.55, p<.001]. The intervention group had a significantly lower mean pain score in the second hour (t = -2.838, p = .006) and fourth hour (t = -4.739, p < .001) when patients turning to the side than did the control group lying supine. Furthermore, patients in the intervention group had significantly higher satisfaction than did those in the control group (t = -2.422, p = .018). No hematoma and significant difference of post-procedural bleeding between groups. CONCLUSION Changing patients' body positions in bed after transcatheter arterial chemoembolization is a safe and effective method of decreasing back pain, and increasing patients' satisfaction, without increasing the complications of bleeding and hematoma. Clinicians should change the positions of people with hepatocellular carcinoma 2 hours after they receive transcatheter arterial chemoembolization.",2020,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","['people with hepatocellular carcinoma', '78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled', 'People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain', 'people with transfemoral cardiac catheterization']","['body positioning', 'transcatheter arterial chemoembolization']","['pain level', 'pain levels', 'back pain', 'numerical rating scale -11', 'bleeding', 'mean pain score', 'higher satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",78.0,0.143191,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","[{'ForeName': 'Kai-Ting', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: kaiting105866@gmail.com.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National, Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: cjliu@ntu.edu.tw.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'Post-Baccalaureate Program in Nursing, Taipei Medical University, No. 250 Wu-Xing Street, Taipei City, 110, Taiwan. Electronic address: hsiuting@tmu.edu.tw.'}, {'ForeName': 'Tse-Pin', 'Initials': 'TP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: 021077@ntuh.gov.tw.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: nate770407@gmail.com.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Nursing, National Yang-Ming University, No.155, Sec.2, Li-Nong Street, Taipei City, 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103641'] 1938,32546490,"Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study).","OBJECTIVE To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. DESIGN A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. SETTING Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. PARTICIPANTS 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). INTERVENTIONS Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. MAIN OUTCOME MEASURES Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER). RESULTS Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. CONCLUSIONS Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up. TRIAL REGISTRATION NUMBER ClinicalTrials.gov NCT02323412.",2020,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","['patients with chronic low back pain and Modic changes (AIM) study', '180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62', 'Hospital outpatient clinics at six hospitals in Norway', 'patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment', 'patients with chronic low back pain and Modic changes']","['Amoxicillin', 'placebo-control (n=91', 'amoxicillin', 'amoxicillin or placebo', 'antibiotics', 'antibiotic treatment', 'placebo']","['Cost-utility', 'Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss', 'Mean (SD) total cost', 'probability of amoxicillin being cost-effective', 'incremental cost-effectiveness ratio (ICER', 'healthcare consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0029916', 'cui_str': 'Hospital Outpatient Clinics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",180.0,0.51751,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","[{'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Research and Innovation, Oslo University Hospital, Oslo, Norway mgrotle@oslomet.no.'}, {'ForeName': 'Lars Christian', 'Initials': 'LC', 'LastName': 'Bråten', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Physical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Zinajda', 'Initials': 'Z', 'LastName': 'Zolic-Karlsson', 'Affiliation': 'Regional Research Support Services, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Munk Killingmo', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Oslo, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tingulstad', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, Oslo, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Froholdt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Wigemyr', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, VU University, Amsterdam, Netherlands.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Clinic for Surgery and Neurology, FORMI, Oslo, Norway.'}, {'ForeName': 'John-Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'Department of Neurology and FORMI, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035461'] 1939,32546493,Role of the intelligent exercise rehabilitation management system on adherence of cardiac rehabilitation in patients with coronary heart disease: a randomised controlled crossover study protocol.,"INTRODUCTION The benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors. METHODS AND ANALYSIS We propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6 weeks and usual care for the last 6 weeks, while patients assigned to group 2 will receive usual care for the first 6 weeks and will use IERMS in the last 6 weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6 weeks and 12 weeks. ETHICS AND DISSEMINATION This study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER ChiCTR1900028182; Pre-results.",2020,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","['70 patients with coronary heart disease (CHD', 'patients with coronary heart disease']","['Home-based CR (HBCR', 'IERMS intervention together with usual care for the first 6\u2009weeks and usual care for the last 6\u2009weeks, while patients assigned to group 2 will receive usual care for the first 6\u2009weeks and will use IERMS', 'Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR', 'intelligent exercise rehabilitation management system', 'cardiac rehabilitation (CR']","['exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors', 'adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors', 'adherence of cardiac rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]",70.0,0.0831069,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","[{'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wenji', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Meidi', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China lifeng2912@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-036720'] 1940,32548299,Tumor Sphericity Predicts Response in Neoadjuvant Chemotherapy for Invasive Breast Cancer.,"This retrospective study examined magnetic resonance imaging (MRI)-derived tumor sphericity (SPH) as a quantitative measure of breast tumor morphology, and investigated the association between SPH and reader-assessed morphological pattern (MP). In addition, association of SPH with pathologic complete response was evaluated in patients enrolled in an adaptively randomized clinical trial designed to rapidly identify new agents for breast cancer. All patients underwent MRI examinations at multiple time points during the treatment. SPH values from pretreatment (T0) and early-treatment (T1) were investigated in this study. MP on T0 dynamic contrast-enhanced MRI was ranked from 1 to 5 in 220 patients. Mean SPH values decreased with the increased order of MP. SPH was higher in patients with pathologic complete response than in patients without (difference at T0: 0.04, 95% confidence interval [CI]: 0.02-0.05, P < .001; difference at T1: 0.03, 95% CI: 0.02-0.04, P < .001). The area under the receiver operating characteristic curve was estimated as 0.61 (95% CI, 0.57-0.65) at T0 and 0.58 (95% CI, 0.55-0.62) at T1. When the analysis was performed by cancer subtype defined by hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status, highest area under the receiver operating characteristic curve were observed in HR-/HER2+: 0.67 (95% CI, 0.54-0.80) at T0, and 0.63 (95% CI, 0.51-0.76) at T1. Tumor SPH showed promise to quantify MRI MPs and as a biomarker for predicting treatment outcome at pre- or early-treatment time points.",2020,Tumor SPH showed promise to quantify MRI MPs and as a biomarker for predicting treatment outcome at pre- or early-treatment time points.,['Invasive Breast Cancer'],"['Neoadjuvant Chemotherapy', 'magnetic resonance imaging (MRI)-derived tumor sphericity (SPH']","['SPH', 'MP on T0 dynamic contrast-enhanced MRI', 'SPH values', 'area under the receiver operating characteristic curve', 'Mean SPH values', 'hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status, highest area under the receiver operating characteristic curve']","[{'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205250', 'cui_str': 'High'}]",220.0,0.0801601,Tumor SPH showed promise to quantify MRI MPs and as a biomarker for predicting treatment outcome at pre- or early-treatment time points.,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Newitt', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Bo La', 'Initials': 'B', 'LastName': 'Yun', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Ella F', 'Initials': 'EF', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Arasu', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Wilmes', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gibbs', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Alex Anh-Tu', 'Initials': 'AA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Natsuko', 'Initials': 'N', 'LastName': 'Onishi', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kornak', 'Affiliation': 'Departments of Epidemiology and Biostatistics; and.'}, {'ForeName': 'Bonnie N', 'Initials': 'BN', 'LastName': 'Joe', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'Surgery, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}]","Tomography (Ann Arbor, Mich.)",['10.18383/j.tom.2020.00016'] 1941,32548771,Fast acquisition abdominal MRI study for the investigation of suspected acute appendicitis in paediatric patients.,"OBJECTIVES To assess the diagnostic accuracy of fast acquisition MRI in suspected cases of paediatric appendicitis presenting to a tertiary referral hospital. MATERIALS AND METHODS A prospective study was undertaken between May and October 2017 of 52 children who presented with suspected appendicitis and were referred for an abdominal ultrasound. All patients included in this study received both an abdominal ultrasound and five-sequence MRI consisting of axial and coronal gradient echo T2 scans, fat-saturated SSFSE and a diffusion-weighted scan. Participants were randomised into groups of MRI with breath-holds or MRI with free breathing. A patient satisfaction survey was also carried out. Histopathology findings, where available, were used as a gold standard for the purposes of data analysis. Statistical analysis was performed, and p values < 0.05 were considered statistically significant. RESULTS Ultrasound had a sensitivity and specificity of 25% and 92.9%, respectively. MRI with breath-hold had a sensitivity and specificity of 81.8% and 66.7%, respectively, whilst MRI with free breathing was superior with sensitivity and specificity of 92.3% and 84.2%, respectively. MRI with free breathing was also more time efficient (p < 0.0001). Group statistics were comparable (p < 0.05). CONCLUSIONS The use of fast acquisition MRI protocols, particularly free breathing sequences, for patients admitted with suspected appendicitis can result in faster diagnosis, treatment and discharge. It also has a statistically significant diagnostic advantage over ultrasound. Additionally, the higher specificity of MR can reduce the number of negative appendectomies performed in tertiary centres.",2020,MRI with free breathing was also more time efficient (p < 0.0001).,"['suspected cases of paediatric appendicitis presenting to a tertiary referral hospital', '52 children who presented with suspected appendicitis and were referred for an abdominal ultrasound', 'patients admitted with suspected appendicitis', 'suspected acute appendicitis in paediatric patients']","['fast acquisition MRI', 'MRI with breath-holds or MRI with free breathing', 'abdominal ultrasound and five-sequence MRI consisting of axial and coronal gradient echo T2 scans, fat-saturated SSFSE and a diffusion-weighted scan', 'fast acquisition MRI protocols']",['sensitivity and specificity'],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",52.0,0.0479346,MRI with free breathing was also more time efficient (p < 0.0001).,"[{'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Duffy', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Carey', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Power', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ryan', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Joyce', 'Affiliation': 'Department of Radiology, University College Cork, Cork, Ireland.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Feeley', 'Affiliation': 'School of Medicine, University College Cork, Cork, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'PET/CT-MRI Unit, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Emmet', 'Initials': 'E', 'LastName': 'Andrews', 'Affiliation': 'Department of Surgery, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'McEntee', 'Affiliation': 'Department of Radiography, University College Cork, Cork, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Bogue', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Maher', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Owen J', 'Initials': 'OJ', 'LastName': ""O' Connor"", 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland. oj.oconnor@ucc.ie.'}]",Insights into imaging,['10.1186/s13244-020-00882-7'] 1942,32546125,Erythropoietin as candidate for supportive treatment of severe COVID-19.,"In light of the present therapeutic situation in COVID-19, any measure to improve course and outcome of seriously affected individuals is of utmost importance. We recap here evidence that supports the use of human recombinant erythropoietin (EPO) for ameliorating course and outcome of seriously ill COVID-19 patients. This brief expert review grounds on available subject-relevant literature searched until May 14, 2020, including Medline, Google Scholar, and preprint servers. We delineate in brief sections, each introduced by a summary of respective COVID-19 references, how EPO may target a number of the gravest sequelae of these patients. EPO is expected to: (1) improve respiration at several levels including lung, brainstem, spinal cord and respiratory muscles; (2) counteract overshooting inflammation caused by cytokine storm/ inflammasome; (3) act neuroprotective and neuroregenerative in brain and peripheral nervous system. Based on this accumulating experimental and clinical evidence, we finally provide the research design for a double-blind placebo-controlled randomized clinical trial including severely affected patients, which is planned to start shortly.",2020,"In light of the present therapeutic situation in COVID-19, any measure to improve course and outcome of seriously affected individuals is of utmost importance.",['seriously ill COVID-19 patients'],"['human recombinant erythropoietin (EPO', 'Erythropoietin', 'EPO', 'placebo']",[],"[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0997797,"In light of the present therapeutic situation in COVID-19, any measure to improve course and outcome of seriously affected individuals is of utmost importance.","[{'ForeName': 'Hannelore', 'Initials': 'H', 'LastName': 'Ehrenreich', 'Affiliation': 'Clinical Neuroscience, Max Planck Institute of Experimental Medicine, Göttingen, Germany. ehrenreich@em.mpg.de.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Weissenborn', 'Affiliation': 'Department of Neurology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Begemann', 'Affiliation': 'Clinical Neuroscience, Max Planck Institute of Experimental Medicine, Göttingen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Busch', 'Affiliation': 'Center of Internal Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain.'}, {'ForeName': 'Kamilla W', 'Initials': 'KW', 'LastName': 'Miskowiak', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital, Rigshospitalet, Copenhagen, Denmark. Kamilla.miskowiak@regionh.dk.'}]","Molecular medicine (Cambridge, Mass.)",['10.1186/s10020-020-00186-y'] 1943,32544346,Promoting unsupervised walking in women with fibromyalgia: a randomized controlled trial.,"The objective of this study is to test the efficacy of a group motivational plus implementation intentions intervention in promoting adherence to an unsupervised walking program recommended for fibromyalgia, compared to an implementation intentions condition and to an active control condition. A triple-blind, randomized, longitudinal study with measures at baseline, short (seven weeks post-intervention), mid (12 weeks) and long-term (36 weeks) is performed. Data are analyzed using multilevel longitudinal growth curve two-level modelling. Participants are 157 women with fibromyalgia. In the short-term, adherence to the minimum and to the standard walking program (primary outcome measures) is explained by time (both p <.001), motivational plus implementation intentions intervention (both p <.001) and by their interaction (both p <.001). Regarding the secondary outcomes, only physical function is explained by time ( p <.001), motivational plus implementation intentions intervention ( p <.05) and by their interaction ( p <.05). Motivational plus implementation intentions intervention achieve the promotion of walking as an exercise in the short-term; furthermore, physical function of the women in this condition is better than in the other two intervention groups, which is a relevant outcome from a rehabilitation point of view. However, more studies are needed to maintain the exercise at mid and long-term.",2020,"Regarding the secondary outcomes, only physical function is explained by time ( p <.001), motivational plus implementation intentions intervention ( p <.05) and by their interaction ( p <.05).","['women with fibromyalgia', '157 women with fibromyalgia']","['group motivational plus implementation intentions intervention', 'Motivational plus implementation intentions intervention']",['motivational plus implementation intentions intervention'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",157.0,0.0679611,"Regarding the secondary outcomes, only physical function is explained by time ( p <.001), motivational plus implementation intentions intervention ( p <.05) and by their interaction ( p <.05).","[{'ForeName': 'María A', 'Initials': 'MA', 'LastName': 'Pastor-Mira', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'López-Roig', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Martínez-Zaragoza', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lledó', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Velasco', 'Affiliation': 'Department of Medicine & Surgery, Psychology, Preventive Medicine & Public Health, Rey Juan Carlos University , Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'León', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Écija Gallardo', 'Affiliation': 'Department of Medicine & Surgery, Psychology, Preventive Medicine & Public Health, Rey Juan Carlos University , Spain.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Peñacoba', 'Affiliation': 'Department of Medicine & Surgery, Psychology, Preventive Medicine & Public Health, Rey Juan Carlos University , Spain.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1774068'] 1944,32549100,Effects of Lidocaine Oropharyngeal Spray Applied Before Endotracheal Intubation on QT Dispersion in Patients Undergoing Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Study.,"OBJECTIVE To investigate the effects of lidocaine oropharyngeal spray applied before endotracheal intubation on hemodynamic responses and electrocardiographic parameters in patients undergoing coronary artery bypass grafting. METHODS A total of 60 patients who underwent coronary artery bypass grafting surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups, the topical lidocaine group (administration of 10% lidocaine oropharyngeal spray, five minutes before laryngoscopy and endotracheal intubation) and the control group. Both groups were compared with each other in terms of main hemodynamic parameters including mean arterial pressure and heart rate, as well as P and QT wave dispersion durations, before and after endotracheal intubation. RESULTS The groups were similar in terms of age, gender, and other demographics and basic clinical characteristics. There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation. The increase in QT dispersion duration was not statistically significant in the topical lidocaine group, whereas the increase in QT dispersion duration was statistically significant in the control group. When the groups were compared in terms of P wave dispersion durations, there were significant decreases in both groups, but there was no significant difference between the groups. CONCLUSION Our study revealed that the topical lidocaine administration before endotracheal intubation prevented increase of QT dispersion duration in patients undergoing coronary artery bypass grafting. TRIAL REGISTRATION NCT03304431.",2020,There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation.,"['60 patients who underwent', 'patients undergoing coronary artery bypass grafting', 'Patients Undergoing Coronary Artery Bypass Grafting']","['Lidocaine Oropharyngeal Spray Applied Before Endotracheal Intubation', 'endotracheal intubation', 'lidocaine oropharyngeal spray, five minutes before laryngoscopy and endotracheal intubation', 'lidocaine', 'topical lidocaine', 'coronary artery bypass grafting surgery', 'lidocaine oropharyngeal spray']","['QT dispersion durations', 'hemodynamic responses and electrocardiographic parameters', 'mean arterial pressure and heart rate, as well as P and QT wave dispersion durations', 'QT Dispersion', 'QT dispersion duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",60.0,0.0257983,There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation.,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bilgi', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Velioglu', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Yoldas', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Cosgun', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yuksel', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Karagoz', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Yildiz', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Abdulhamit', 'Initials': 'A', 'LastName': 'Es', 'Affiliation': 'Abant Izzet Baysal University Faculty of Economics and Administrative Sciences Bolu Turkey Abant Izzet Baysal University Faculty of Economics and Administrative Sciences, Bolu, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Caliskan', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Kemalettin', 'Initials': 'K', 'LastName': 'Erdem', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirhan', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0112'] 1945,32558314,Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.,"OBJECTIVE Antimicrobial peptide, KSL-W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4-day plaque regrowth clinical study. METHODS This Phase 2 two-armed placebo-controlled, double blind, randomized (1:1), multiple dose, and single-center study was evaluated in a proof of concept for the APCG containing 30 mg antimicrobial peptide KSL-W. Twenty six generally healthy subjects were consented and randomized into the study. The subjects were administered a dose three times per day for four treatment days following a complete dental prophylaxis. Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial. Twelve to 16 hr prior to the baseline visit, the subjects were to abstain from oral hygiene care. The Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams were obtained at both Day 0 and Day 4. RESULTS All randomized study subjects that received either APCG or placebo gum completed the study with no significant adverse events recorded. The APCG significantly inhibited the regrowth of dental plaque over the course of 4 days. The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003. CONCLUSION Considering the limited sample size, the proof of concept analysis in this Phase 2 study confirmed that APCG is effective against dental plaque formation and safe for human use. (ClinicalTrials.gov Study ID# NCT02864901).",2020,"The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003. ","['W. Twenty six generally healthy subjects', 'Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial']","['APCG', 'APCG or placebo', 'peptide chewing gum', 'APCG containing 30\u2009mg antimicrobial peptide KSL', 'placebo']","['QHT', 'Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams', 'regrowth of dental plaque']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0447424', 'cui_str': 'Oral soft tissues structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",26.0,0.308301,"The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003. ","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kirkwood', 'Affiliation': 'Dental and Craniofacial Trauma, US Army Institute of Surgical Research, San Antonio, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'ClinSmart LLC, Newton, Pennsylvania.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, Indiana.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, Indiana.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Leung', 'Affiliation': 'Dental and Craniofacial Trauma, US Army Institute of Surgical Research, San Antonio, Texas.'}]",Clinical and experimental dental research,['10.1002/cre2.275'] 1946,32552691,Modified-ramped position: a new position for intubation of obese females: a randomized controlled pilot study.,"BACKGROUND Endotracheal intubation requires optimum position of the head and neck. In obese females, the usual ramped position might not provide adequate intubating conditions. We hypothesized that a new position, termed modified-ramped position, during induction of anesthesia would facilitate endotracheal intubation through bringing the breasts away from the laryngoscope and would also improve the laryngeal visualization. METHODS Sixty obese female patients scheduled for general anesthesia were randomly assigned into either ramped or modified-ramped position during induction of anesthesia. In the ramped position (n = 30), the patient head and shoulders were elevated to achieve alignment of the sternal notch and the external auditory meatus; while in the modified-ramped position (n = 30), the patient shoulders were elevated using a special pillow, and the head was extended to the most possible range. Our primary outcome was the incidence of failed laryngoscopic insertion in the oral cavity (the need for patient repositioning). Other outcomes included time till vocal cord visualization, time till successful endotracheal intubation, difficulty of the mask ventilation, and Cormack-Lehane grade for laryngeal view. RESULTS Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001). Modified-ramped position showed lower incidence of difficult mask ventilation, shorter time for glottic visualization, and shorter time for endotracheal tube insertion compared to the ramped position. The Cormack-Lehane grade was better in the modified-ramped position. CONCLUSION Modified-ramped position provided better intubating conditions, improved the laryngeal view, and eliminated the need for repositioning of obese female patients during insertion of the laryngoscope compared to ramped position. CLINICAL TRIAL REGISTRATION Identifier: NCT03640442. Date: August 2018.",2020,"RESULTS Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001).","['obese females', 'obese female patients', 'Sixty obese female patients scheduled for general anesthesia']","['ramped or modified-ramped position during induction of anesthesia', 'Modified-ramped position']","['time till vocal cord visualization, time till successful endotracheal intubation, difficulty of the mask ventilation, and Cormack-Lehane grade for laryngeal view', 'incidence of failed laryngoscopic insertion in the oral cavity (the need for patient repositioning', 'incidence of difficult mask ventilation, shorter time for glottic visualization, and shorter time for endotracheal tube insertion']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C2362912', 'cui_str': 'Patient Moving and Lifting'}, {'cui': 'C4706398', 'cui_str': 'Difficult mask ventilation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}]",60.0,0.0652977,"RESULTS Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt. ahmedmohamedhasanin@gmail.com.'}, {'ForeName': 'Hager', 'Initials': 'H', 'LastName': 'Tarek', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Maha M A', 'Initials': 'MMA', 'LastName': 'Mostafa', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Arafa', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Safina', 'Affiliation': 'Department of surgery, Cairo university, Giza, Egypt.'}, {'ForeName': 'Mona H', 'Initials': 'MH', 'LastName': 'Elsherbiny', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hosny', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Gado', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Almenesey', 'Affiliation': 'Department of anesthesia and critical care medicine, Beni suef university, Beni suef, Egypt.'}, {'ForeName': 'Ghada Adel', 'Initials': 'GA', 'LastName': 'Hamden', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mahmoud', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}]",BMC anesthesiology,['10.1186/s12871-020-01070-2'] 1947,32553103,Comparison of blood loss between intra-articular and intra-venous administration of tranexamic acid in primary total knee arthroplasty.,"OBJECTIVE To compare the blood loss between intra-articular and intra-venous administration of tranexamic acid (TXA) in patients undergoing primary total knee arthroplasty. DESIGN OF STUDY It was a randomized controlled trial. Study duration and settings: This study was carried out at the Orthopedic Departments of Combined Military Hospital Lahore and Rawalpindi from Jan 2016 to March 2018. METHODOLOGY Patients of both the genders were involved this study who had age in the rage of 40-80 years undergoing primary unilateral total knee arthroplasty for degenerative conditions like osteoarthritis and rheumatoid arthritis. These patients were randomly divided into two treatment groups. Patients in IA group received intra-articular tranexamic acid while those in IV group received intravenous tranexamic acid. From all the patients, a written signed consent was taken. FINDINGS Females were predominant with male-to-female ratio of 1:3.7. The mean age of the patients was 67.3 ± 8.2 years while the mean BMI was 30.9 ± 2.9 Kg/m 2 . Majority (n = 191, 95.5%) of the patients had osteoarthritis while remaining 9 (4.5%) patients had rheumatoid arthritis. There was no statistically significant difference between intra-articular and intra-venous administration of tranexamic acid in terms of mean post-operative hemoglobin (9.93 ± 1.14 vs. 9.87 ± 1.26 g/dL; p-value = 0.724), mean post-operative hematocrit (34.8 ± 1.66 vs. 34.73 ± 1.27%; p-value = 0.594), and mean fall in hemoglobin (2.27 ± 0.34 vs. 2.25 ± 0.30 g/dL; p-value = 0.587) and hematocrit (2.34 ± 0.94 vs. 2.46 ± 0.28%; p-value = 0.216). CONCLUSION Intra-articular administration of tranexamic acid was found to be as effective and safe as intra-venous administration in reducing blood loss in primary total knee arthroplasty. Due to convenience, the use of intra-articular administration of tranexamic acid after primary TKA may be considered in future practice.",2020,There was no statistically significant difference between intra-articular and intra-venous administration of tranexamic acid in terms of mean post-operative hemoglobin (9.93 ± ,"['Majority (n\xa0', 'Females were predominant with male-to-female ratio of 1:3.7', 'primary total knee arthroplasty', 'patients undergoing primary total knee arthroplasty', 'The mean age of the patients was 67.3\xa0±\xa08.2\xa0years while the mean BMI was 30.9\xa0±', 'Patients of both the genders were involved this study who had age in the rage of 40-80\xa0years undergoing primary unilateral total knee arthroplasty for degenerative conditions like osteoarthritis and rheumatoid arthritis', 'Orthopedic Departments of Combined Military Hospital Lahore and Rawalpindi from Jan 2016 to March 2018']","['tranexamic acid (TXA', 'tranexamic acid', 'intra-articular tranexamic acid']","['mean post-operative hematocrit', 'hematocrit', 'mean fall in hemoglobin', 'osteoarthritis', 'rheumatoid arthritis', 'blood loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0795964,There was no statistically significant difference between intra-articular and intra-venous administration of tranexamic acid in terms of mean post-operative hemoglobin (9.93 ± ,"[{'ForeName': 'Muhammad Suhail', 'Initials': 'MS', 'LastName': 'Amin', 'Affiliation': 'Professor Orthopedic, CMH Hospital Rawalpindi and CMH Lahore Orthopedic ward, CMH Hospital Rawalpindi, Pakistan.'}, {'ForeName': 'Muhammad Khurram', 'Initials': 'MK', 'LastName': 'Habib', 'Affiliation': 'Assistant Professor Orthopedics, DHQ Hospital Faisalabad, Clinical Fellow, CMH Lahore, DHQ Hospital Faisalabad Orthopedics ward, Pakistan.'}, {'ForeName': 'Aziz Ur', 'Initials': 'AU', 'LastName': 'Rehman', 'Affiliation': 'Clinical fellow CMH Hospital Rawalpindi and CMH Lahore, Pakistan.'}]",SICOT-J,['10.1051/sicotj/2020017'] 1948,32562206,Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial.,"BACKGROUND AND OBJECTIVE In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy? METHODS The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor. RESULTS Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy). CONCLUSIONS Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS. GOV UNIQUE IDENTIFIER NCT02164864.",2020,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","['patients with atrial fibrillation who underwent percutaneous coronary intervention', 'patients receiving/not receiving a proton pump inhibitor', 'Patients with Atrial Fibrillation', 'patients with atrial fibrillation following percutaneous coronary intervention', 'Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline', '2725 patients with atrial fibrillation post-percutaneous coronary intervention to']","['warfarin triple therapy', 'dabigatran dual therapy', 'Dabigatran', 'clopidogrel or ticagrelor', 'Proton Pump Inhibitor', 'warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin', 'proton pump inhibitor', 'Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention']","['risk of major bleeding events', 'risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",2725.0,0.0706981,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","[{'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil. jose.nicolau@incor.usp.br.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'Mainanalytics ma GmbH, Sulzbach (Taunus), Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, FACT, INSERM U_1148, Paris, France.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Godoy', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-020-01323-x'] 1949,32562682,"Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial.","BACKGROUND In A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up. METHODS ARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion. Patients were randomly assigned (1:1) by a web-based data collection system, stratified by clinical centre in a random permuted block design with block sizes of two, four, and six, to medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number). Although patients and investigators at a given centre were not masked to treatment assignment, investigators at other centres and those in the clinical coordinating centre were not informed of assignment or outcomes at any of the centres. The primary outcome was time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care, and monitored by an independent committee using an adaptive approach with interim analyses. Enrolment began on April 4, 2007, and was halted on April 15, 2013, after which follow-up continued until July 15, 2015. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00389181. FINDINGS Of 1740 patients screened, 226 were randomly assigned to medical management alone (n=110) or medical management plus interventional therapy (n=116). During a mean follow-up of 50·4 months (SD 22·9), the incidence of death or symptomatic stroke was lower with medical management alone (15 of 110, 3·39 per 100 patient-years) than with medical management with interventional therapy (41 of 116, 12·32 per 100 patient-years; hazard ratio 0·31, 95% CI 0·17 to 0·56). Two patients in the medical management group and four in the interventional therapy group (two attributed to intervention) died during follow-up. Adverse events were observed less often in patients allocated to medical management compared with interventional therapy (283 vs 369; 58·97 vs 78·73 per 100 patient-years; risk difference -19·76, 95% CI -30·33 to -9·19). INTERPRETATION After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation. The data concerning the disparity in outcomes should affect standard specialist practice and the information presented to patients. The even longer-term risks and differences between the two therapeutic approaches remains uncertain. FUNDING National Institute of Neurological Disorders and Stroke for the randomisation phase and Vital Projects Fund for the follow-up phase.",2020,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","['patients with an unruptured brain arteriovenous malformation', '1740 patients screened, 226 were randomly assigned to', '39 clinical centres in nine countries', 'Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion', 'unruptured brain arteriovenous malformations (ARUBA']","['interventional therapy versus medical management alone', 'medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number', 'medical management alone (n=110) or medical management plus interventional therapy']","['death or symptomatic stroke', 'Adverse events', ""time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care"", 'symptomatic stroke or death', 'incidence of death or symptomatic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0003857', 'cui_str': 'Congenital arteriovenous malformation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C3846112', 'cui_str': 'Stereotactic radiosurgery'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",226.0,0.149025,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","[{'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Mohr', 'Affiliation': 'Doris and Stanley Tananbaum Stroke Center, The Neurological Institute, Columbia University Irving Medical Center, New York, NY, USA. Electronic address: jpm10@cumc.columbia.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Department of Neurology, Klinikum Frankfurt/Oder, Frankfurt/Oder, Germany.'}, {'ForeName': 'Rüdiger von', 'Initials': 'RV', 'LastName': 'Kummer', 'Affiliation': 'Department of Neuroradiology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California, San Francisco, CA, USA.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Albert Einstein Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology and Neurosurgery, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Neuroradiology, APHP-Hôpital Lariboisière, Université Paris Diderot-Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Libman', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pile-Spellman', 'Affiliation': 'Department of Neuroradiology, NYU-Winthrop Medical Center, Mineola, NY, USA.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Harkness', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cordonnier', 'Affiliation': 'Université Lille, Inserm, CHU Lille, U1172, LilNCog, Lille Neuroscience and Cognition, Lille, France.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moquete', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Department of Interventional Neuroradiology, Jean Minjoz Hospital, University of Franche Comté, Besançon, France.'}, {'ForeName': 'Catharina J M', 'Initials': 'CJM', 'LastName': 'Klijn', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stapf', 'Affiliation': ""Neuroscience Axis, Neurovascular Group, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Division of Neurology, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada; Department of Neurosciences, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30181-2'] 1950,32562683,Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.,"BACKGROUND Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial. METHODS REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 . Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952. FINDINGS Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1-5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85-1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018). INTERPRETATION Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated. FUNDING Eli Lilly and Company.",2020,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018). ","['371 sites in 24 countries', '8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned', 'men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 ', 'Between Aug 18, 2011, and Aug 14, 2013, 9901 participants', 'type 2 diabetes', 'people with type 2 diabetes']","['placebo', 'dulaglutide (1·5 mg) or an equal volume of matching placebo', 'dulaglutide', 'glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide']","['hazard of substantive cognitive impairment', 'stroke, myocardial infarction, or death from cardiovascular or unknown causes', 'cognitive outcome', 'Cognitive function', 'cognitive impairment', 'Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",9901.0,0.689964,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018). ","[{'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cukierman-Yaffe', 'Affiliation': 'Endocrinology Institute, Gertner Institute, Sheba Medical Center, Ramat-Gan, Israel; Epidemiology Department, Sackler School of Medicine, Herceg Institute of Aging, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Luis-Emilio', 'Initials': 'LE', 'LastName': 'García-Pérez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Angelyn', 'Initials': 'A', 'LastName': 'Bethel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, India.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health and Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital, Warsaw, Poland.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Center, Sofia, Bulgaria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30173-3'] 1951,32562684,"Safety and immunogenicity of the α-synuclein active immunotherapeutic PD01A in patients with Parkinson's disease: a randomised, single-blinded, phase 1 trial.","BACKGROUND Robust evidence supports the role of α-synuclein pathology as a driver of neuronal dysfunction in Parkinson's disease. PD01A is a specific active immunotherapy with a short peptide formulation targeted against oligomeric α-synuclein. This phase 1 study assessed the safety and tolerability of the PD01A immunotherapeutic in patients with Parkinson's disease. METHODS We did a first-in-human, randomised, phase 1 study of immunisations with PD01A, followed by three consecutive study extensions. Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria. Patients were randomly assigned (1:1), using a computer-generated sequence with varying block size, to receive four subcutaneous immunisations with either 15 μg or 75 μg PD01A injected into the upper arms and followed up initially for 52 weeks, followed by a further 39 weeks' follow-up. Patients were then randomly assigned (1:1) again to receive the first booster immunisation at 15 μg or 75 μg and were followed up for 24 weeks. All patients received a second booster immunisation of 75 μg and were followed up for an additional 52 weeks. Patients were masked to dose allocation. Primary (safety) analyses included all treated patients. These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16. FINDINGS 32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible and randomly assigned to receive four PD01A priming immunisations. One patient had a diagnosis change to multiple system atrophy and was withdrawn and two patients withdrew consent during the studies. 21 (87%) of 24 patients received all six immunisations and completed 221-259 weeks in-study (two patients in the 15 μg dose group and one patient in the 75 μg dose group discontinued). All patients experienced at least one adverse event, but most of them were considered unrelated to study treatment (except for transient local injection site reactions, which affected all but one patient). Serial MRI assessments also ruled out inflammatory processes. Systemic treatment-related adverse events were fatigue (n=4), headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2). The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group. Antibody titres returned to baseline over 2 years, but could be rapidly reactivated after booster immunisation from week 116 onwards, reaching geometric group mean titres up to 1:20218. INTERPRETATION Repeated administrations of PD01A were safe and well tolerated over an extended period. Specific active immunotherapy resulted in a substantial humoral immune response with target engagement. Phase 2 studies are needed to further assess the safety and efficacy of PD01A for the treatment of Parkinson's disease. FUNDING AFFiRiS, Michael J Fox Foundation.",2020,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[""patients with Parkinson's disease"", ""Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria"", 'These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16', '32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible']","['PD01A', 'PD01A immunotherapeutic', 'α-synuclein active immunotherapeutic PD01A']","['Safety and immunogenicity', 'geometric group mean titre of antibodies against the immunising peptide PD01', 'safety and tolerability', 'headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2', 'Antibody titres', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0165073', 'cui_str': 'Synuclein'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",32.0,0.129353,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[{'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Volc', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kutzelnigg', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lührs', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Thun-Hohenstein', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Schneeberger', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Galabova', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Majbour', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Vaikath', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El-Agnaf', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Dorian', 'Initials': 'D', 'LastName': 'Winter', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mihailovska', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mairhofer', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwenke', 'Affiliation': 'Schwenke Consulting: Strategies and Solutions in Statistics, Berlin, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Staffler', 'Affiliation': 'AFFiRiS, Vienna, Austria. Electronic address: guenther.staffler@affiris.com.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Medori', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30136-8'] 1952,32565848,Biocurcumin as Radiosensitiser for Cervical Cancer Study (BRACES): A Double-Blind Randomised Placebo-Controlled Trial.,"Cervical cancer is a leading cause of death among women worldwide, particularly in Indonesia. The main treatment of advanced-stage cervical cancer is radiation; however, the outcomes do not meet the required expectations. [1,7-Bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5dione] has been reported in several studies for its potency in cancer therapy. This study aims to investigate the clinical and molecular [(malondialdehyde (MDA) and NF- κ B levels] effects, apoptotic index, and safety of Biocurcumin (BCM-95) as a radiosensitiser in cervical cancer. In this double-blind placebo randomised-controlled trial, we randomised 121 patients into 2 groups (BCM-95 or placebo). MDA and their NF- κ B levels and apoptotic index were measured before and after administering 24 Gy of radiation. MDA was identified using Wills' method, whereas NF- κ B was identified via ELISA. The apoptotic index was identified using TUNEL and DAPI staining. The clinical response was classified based on the RECIST. MDA levels before radiation were similar between both groups in per protocol and intention-to-treat (ITT) analyses ( p = 0.53 and p = 0.16, respectively). After radiation, MDA levels increased in both groups with no significant differences in per protocol and ITT analyses ( p = 0.52 and p = 0.18, respectively). NF- κ B levels before radiation were similar between the two groups in per protocol and ITT analyses ( p = 0.92 and p = 0.98, respectively). After radiation, the BCM-95 group showed an increase in the NF- κ B levels compared with the placebo group in per protocol analysis but not in ITT analysis ( p = 0.018 and p = 0.42, respectively). The BCM-95 group had a higher apoptotic index before radiation in per protocol analysis but not in ITT analysis ( p = 0.01 and p = 0.61, respectively). After radiation, the apoptotic index remained higher in the BCM-95 group in per protocol analysis but not in ITT analysis ( p = 0.04 and p = 0.91, respectively). There was no significant difference in complete response between the groups (per protocol, p = 0.61; ITT analysis, p = 0.90). Although BCM-95 can regulate ROS, NF- κ B, and apoptosis in human cervical cancer, it is not significant. Therefore, BCM-95 does not improve clinical response to radiation treatment.",2020,"After radiation, the BCM-95 group showed an increase in the NF- κ B levels compared with the placebo group in per protocol analysis but not in ITT analysis ( p = 0.018 and p = 0.42, respectively).","['121 patients into 2 groups', 'Cervical Cancer Study (BRACES', 'cervical cancer']","['Placebo', 'Biocurcumin', 'BCM-95', 'BCM-95 or placebo', '1,7-Bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5dione', 'placebo']","['MDA and their NF- κ B levels and apoptotic index', 'clinical and molecular [(malondialdehyde (MDA) and NF- κ B levels] effects, apoptotic index, and safety of Biocurcumin (BCM-95', 'complete response', 'apoptotic index', 'NF- κ B levels', 'MDA levels', 'NF- κ B levels before radiation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}]","[{'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",121.0,0.415706,"After radiation, the BCM-95 group showed an increase in the NF- κ B levels compared with the placebo group in per protocol analysis but not in ITT analysis ( p = 0.018 and p = 0.42, respectively).","[{'ForeName': 'Sigit', 'Initials': 'S', 'LastName': 'Purbadi', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Primariadewi', 'Initials': 'P', 'LastName': 'Rustamadji', 'Affiliation': 'Department of Anatomic Pathology, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Ani R', 'Initials': 'AR', 'LastName': 'Prijanti', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Sri M', 'Initials': 'SM', 'LastName': 'Sekarutami', 'Affiliation': 'Department of Oncologic Radiology, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Bambang', 'Initials': 'B', 'LastName': 'Sutrisna', 'Affiliation': 'Department of Epidemiologic, Public Health University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Franciscus D', 'Initials': 'FD', 'LastName': 'Suyatna', 'Affiliation': 'Department of Pharmacologic and Therapeutic, Faculty of Medicine University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Andrijono', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/1986793'] 1953,32565928,Pharmacokinetics and pharmacodynamics of levofloxacin in bronchial mucosa and lung tissue of patients undergoing pulmonary operation.,"Levofloxacin is a major antimicrobial agent that is used for the treatment of community-acquired lower respiratory tract infections (LRTIs). The present study was designed to investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of levofloxacin in bronchial mucosa and lung tissue. A total of 32 patients undergoing pulmonary surgery were randomly assigned to one of four groups (8 subjects/group). All patients received a single dose of 500 mg levofloxacin orally prior to the operation. Blood, lung tissue and bronchial mucosa samples were collected prior to treatment and at 1.5, 4, 8, 12 and 24 h following treatment. The drug concentration was determined and PK and PD profiles were calculated using MATLAB software. The peak concentration of levofloxacin was 7.0±1.2 µg/g in lung tissues and 9.4±2.1 µg/g in bronchial mucosa. The corresponding area under the curve between 0 and 24 h (AUC 0-24 ) was 85.7±8.5 and 137.3±19.4 µg h/g. The mean permeability of levofloxacin (ratio of concentration in tissue to that in plasma) was 2.4 in lung tissue and 4.4 in the bronchial mucosa. The PK profiles of levofloxacin in the plasma, lung and bronchial mucosa were described using an integrated one-compartment model. The probability of f AUC 0-24 /minimal inhibitory concentration (MIC) target attainment of levofloxacin against Streptococcus pneumoniae in the lung and bronchial mucosa was maintained at 100% when MIC ≤1 mg/l, while the cumulative fraction of f AUC 0-24 /MIC in the corresponding tissues was 94.4 and 98.1%, respectively. The present study demonstrated the high permeability of levofloxacin in the lung and bronchial mucosa of patients undergoing pulmonary surgery. In conclusion, treatment using 500 mg levofloxacin exhibits good clinical and microbiological efficacy for use in LRTIs that are caused by S. pneumoniae . This trial was registered retrospectively in the Chinese Clinical Trial Registry on January 13, 2020 (registration no. ChiCTR2000029096).",2020,The mean permeability of levofloxacin (ratio of concentration in tissue to that in plasma) was 2.4 in lung tissue and 4.4 in the bronchial mucosa.,"['patients undergoing pulmonary operation', '32 patients undergoing pulmonary surgery', 'Chinese Clinical Trial Registry on January 13, 2020 (registration no', 'patients undergoing pulmonary surgery', 'bronchial mucosa and lung tissue']","['Levofloxacin', 'levofloxacin']","['Blood, lung tissue and bronchial mucosa samples', 'bronchial mucosa and lung tissue', 'mean permeability of levofloxacin (ratio of concentration in tissue to that in plasma', 'drug concentration was determined and PK and PD profiles', 'plasma, lung and bronchial mucosa', 'pharmacokinetics (PK) and pharmacodynamics (PD', 'peak concentration of levofloxacin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038903', 'cui_str': 'Operation on lung'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0225600', 'cui_str': 'Mucous membrane of bronchus'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0225600', 'cui_str': 'Mucous membrane of bronchus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",32.0,0.0170699,The mean permeability of levofloxacin (ratio of concentration in tissue to that in plasma) was 2.4 in lung tissue and 4.4 in the bronchial mucosa.,"[{'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Jicheng', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': 'National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Yingyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}, {'ForeName': 'Yaoguo', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.8715'] 1954,32566019,Expression of lncRNA-HOTAIR in the serum of patients with lymph node metastasis of papillary thyroid carcinoma and its impact.,"The present study aimed to investigate the expression of long non-coding HOX transcript antisense RNA (lncRNA-HOTAIR) in the serum of patients with lymph node metastasis of papillary thyroid carcinoma (PTC) and the underlying mechanism. A total of 89 patients with PTC at Beijing Geriatric Hospital were recruited in this study. Based on the results of color Doppler ultrasound examination, the patients were evaluated for cervical lymph node metastases, and were thereby divided into a metastasis-negative group and a metastasis-positive group. Quantitative fluorescent PCR was used to assess the expression of HOTAIR in serum samples. The PTC cell line TPC-1 was randomly divided into a control and siRNA group. The control group was transfected with a nonsense sequence, while the siRNA group was transfected with si-HOTAIR. After transfection, cell proliferation was evaluated using the MTT assay, and cell migration and invasion were assessed using the cell scratch assay and Transwell assay. Expression levels of vimentin, E-cadherin and proteins associated with the Wnt/β-catenin signaling pathway were assessed using western blot analysis. Based on the results of the ultrasound examination, 53 patients were allocated to the metastasis-negative group, and 36 to the metastasis-positive group. The expression level of lncRNA-HOTAIR was higher in the metastasis-positive group than that in the metastasis-negative group (P<0.05). Compared with the control group, cell proliferation was reduced while cell migration rate and the number of migrating cells were increased in the siRNA group. Compared with the control group, the expression levels of WIF1 and E-cadherin were significantly increased, while the levels of β-catenin and vimentin were significantly decreased. In conclusion, lncRNA-HOTAIR is overexpressed in the serum of patients with lymph node metastasis of PTC. In vitro experiments showed that HOTAIR promoted the proliferation and metastasis of PTC cells by regulating epithelial-mesenchymal transition (EMT) mediated by the Wnt/catenin pathway. Thus, lncRNA-HOTAIR is proposed as a molecular target for the treatment of lymph node metastasis of PTC.",2020,"Compared with the control group, cell proliferation was reduced while cell migration rate and the number of migrating cells were increased in the siRNA group.","['53 patients were allocated to the metastasis-negative group, and 36 to the metastasis-positive group', 'patients with lymph node metastasis of PTC', '89 patients with PTC at Beijing Geriatric Hospital', 'patients with lymph node metastasis of papillary thyroid carcinoma (PTC', 'patients with lymph node metastasis of papillary thyroid carcinoma']","['siRNA group was transfected with si-HOTAIR', 'long non-coding HOX transcript antisense RNA (lncRNA-HOTAIR']","['expression of HOTAIR in serum samples', 'proliferation and metastasis of PTC cells', 'expression levels of WIF1 and E-cadherin', 'expression level of lncRNA-HOTAIR', 'cell migration rate and the number of migrating cells', 'levels of β-catenin and vimentin', 'MTT assay, and cell migration and invasion', 'cell proliferation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0337964', 'cui_str': 'Geriatric hospital'}]","[{'cui': 'C1099354', 'cui_str': 'Small Interfering RNA'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C3253717', 'cui_str': 'HOTAIR long untranslated RNA, human'}, {'cui': 'C2982391', 'cui_str': 'LINC RNA'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042172', 'cui_str': 'E-Cadherin'}, {'cui': 'C2982391', 'cui_str': 'LINC RNA'}, {'cui': 'C1622501', 'cui_str': 'Cell Migration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C0042666', 'cui_str': 'Vimentin'}, {'cui': 'C0647210', 'cui_str': 'monooxyethylene trimethylolpropane tristearate'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}]",89.0,0.0203905,"Compared with the control group, cell proliferation was reduced while cell migration rate and the number of migrating cells were increased in the siRNA group.","[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Beijing Geriatric Hospital, Beijing 100095, P.R. China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Ultrasound, Beijing Geriatric Hospital, Beijing 100095, P.R. China.'}, {'ForeName': 'Baoguo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Head and Neck Surgery, Beijing Cancer Hospital, Beijing 100142, P.R. China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Ultrasound, Beijing Geriatric Hospital, Beijing 100095, P.R. China.'}]",Oncology letters,['10.3892/ol.2020.11620'] 1955,32566061,Effects of Orem's Self-Care Model on the Life Quality of Elderly Patients with Hip Fractures.,"Background Hip fractures of elderly patients are a public health problem worldwide, mostly lying in bed for a long time; therefore, the importance of life quality in such patients is an issue beyond question. Orem's self-care model is a nursing pattern which is introduced with the purpose of improving the self-care ability of individuals, especially the patients suffering from diseases with limits on activity. Objective The aim of this study was to determine the effects of Orem's self-care program on life quality of senile patients with hip fractures. Methods A randomized clinical trial study was conducted on 130 eligible old patients suffering from hip fractures who were selected using easy sampling methods and allocated randomly into two groups of experiment and control. The data were collected through validated questionnaires including visual analogue scale (VAS) and Barthel index for them. The experiment group was treated according to Orem's self-care model, and the control group was treated on the basis of the traditional care model. The data of complications including pneumonia, deep venous thrombosis, urinary infection, wound problem, and bedsore were also gathered. Results As revealed, mean scores of VAS and Barthel index one week after operation in the experiment group were significantly different from the control one ( P < 0.05, P ≤ 0.001). The changes of VAS and Barthel index six weeks postoperatively of the two groups were also statistically significant ( P < 0.05, P ≤ 0.001). Compared with the control group, the difference of complications reduced significantly in the experiment group ( P < 0.05). Accordingly, educational intervention according to Orem's self-care model seemed to be effective in promoting self-care ability for these senile patients. Conclusions According to the obtained results, a self-care program based on Orem's model for elderly patients with hip fractures can improve life quality and reduce perioperative complications significantly. Therefore, it is recommended that this nursing program should be taken into account as a part of treatment measures for these patients.",2020,"Compared with the control group, the difference of complications reduced significantly in the experiment group ( P < 0.05).","['Elderly Patients with Hip Fractures', 'elderly patients with hip fractures', '130 eligible old patients suffering from hip fractures who were selected using easy sampling methods', 'senile patients with hip fractures', 'patients suffering from diseases with limits on activity', 'elderly patients']","[""Orem's Self-Care Model"", ""Orem's self-care program""]","['changes of VAS and Barthel index', 'pneumonia, deep venous thrombosis, urinary infection, wound problem, and bedsore', 'complications', 'life quality', 'mean scores of VAS and Barthel index', 'visual analogue scale (VAS) and Barthel index for them']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0079944', 'cui_str': 'Orem Self-Care Model'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521125', 'cui_str': 'For'}]",130.0,0.0120338,"Compared with the control group, the difference of complications reduced significantly in the experiment group ( P < 0.05).","[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedic Surgery, Peking University China-Japan Friendship School of Clinical Medicine, Beijing 100029, China.'}, {'ForeName': 'Yajia', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopedics, People's Hospital of Ningxia Hui Autonomous Region, Yinchuan 750001, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedics, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Zirong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Yangzhou University, Yangzhou University, Hanjiang Road, Yangzhou 225100, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, China-Japan Friendship Hospital, Beijing 100029, China.'}]",Pain research & management,['10.1155/2020/5602683'] 1956,32566189,Effectiveness of community health workers in improving early initiation and exclusive breastfeeding rates in a low-resource setting: A cluster-randomized longitudinal study.,"Little evidence exists in Kenya on the potential of community health workers (CHWs) in promoting exclusive breastfeeding (EBF) and early breastfeeding initiation (EBI) in resource-restricted settings where very low EBF rates (2% to 12%) have been documented. The study utilized CHWs and assessed their effectiveness in promoting EBF and EBI. The cluster-randomized longitudinal design was used and sixteen villages from Kiandutu Slum in Thika randomly assigned into either intervention group (IG) or comparison group (CG). Pregnant women attending Maternal Child Health (MCH) clinic were recruited. The IG received nutrition education sessions conducted by CHWs at home, two prenatally and six postnatally, plus the routine MCH care. The CG went through routine MCH care only. Infants feeding data were collected at 6, 10, 14, and 24 weeks postpartum by research assistants blinded to the intervention allocation. Differences in EBF and EBI in the two groups were tested using χ 2 tests, Kaplan-Meier survival analysis and generalized estimating equations. Of the 526 recruited in the study, 431 remained and were included in the analysis (IG = 176) and CG (225). The prevalence of EBF at 24 weeks was 45.3% in the IG compared with 15.0% in the CG, revealing a statistically significant difference log rank = 20.277, (1, n  = 314) p  < .001. The difference was not statistically significant in EBI prevalence between the IG (58.2%) and CG (60.3%; χ 2  = 0.008, p  = .928). The CHWs have potential effectiveness in promoting EBF but not EBI. The link between the health center and CHWs should be strengthened to promote EBF.",2020,"The difference was not statistically significant in EBI prevalence between the IG (58.2%) and CG (60.3%; χ 2  = 0.008, p  = .928).","['Of the 526 recruited in the study, 431 remained and were included in the analysis (IG\xa0=\xa0176) and CG (225', 'Pregnant women attending Maternal Child Health (MCH) clinic were recruited', 'sixteen villages from Kiandutu Slum in Thika randomly assigned into either']","['community health workers', 'intervention group (IG) or comparison group (CG']","['EBI prevalence', 'prevalence of EBF', 'EBF and EBI', 'early initiation and exclusive breastfeeding rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",526.0,0.0449863,"The difference was not statistically significant in EBI prevalence between the IG (58.2%) and CG (60.3%; χ 2  = 0.008, p  = .928).","[{'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Mituki-Mungiria', 'Affiliation': 'Department of Human Nutrition Egerton University Egerton Kenya.'}, {'ForeName': 'Prisca', 'Initials': 'P', 'LastName': 'Tuitoek', 'Affiliation': 'Muranga University College Muranga Kenya.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Varpolatai', 'Affiliation': 'School of Education University of Western Ontario London ON Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Ngotho', 'Affiliation': 'Faculty of Health Sciences Egerton University Egerton Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kimani-Murage', 'Affiliation': 'African Population and Health Research Center Nairobi Kenya.'}]",Food science & nutrition,['10.1002/fsn3.1559'] 1957,32546491,Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.,"INTRODUCTION Deficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characterised by intensive and repetitive movements. One treatment approach is to increase the number of steps during the rehabilitation sessions and to improve the balance and the endurance of the patients in the use of technological devices. METHODS AND ANALYSIS This randomised controlled trial aimed to evaluate an innovative rehabilitation treatment of elderly patients with hip fractures. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups: traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View. Assessments will be performed at baseline, at the end of treatment, at 6 months, and at 1 and 2 years after the end of the treatment. Only subjects hospitalised 4 weeks prior to the beginning of the study will be taken into consideration. Twenty treatment sessions will be conducted, divided into three training sessions per week, for 7 weeks. The technological intervention group will carry out 30 min sessions of traditional therapy and 20 min of treatment with a technological device. The control group will perform traditional therapy sessions, each lasting 50 min. The primary outcomes are risk of falling, gait performance and fear of falling. ETHICS AND DISSEMINATION The study was approved by the Istituto di Ricerca e Cura a Carattere Scientifica, Istituto Nazionale Ricovero e Cura Anziani Ethics Committee, with identification code number 19 014. Trial results will be submitted for publication in journals and conferences. TRIAL REGISTRATION NUMBER NCT04095338.",2020,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","['older people after hip fracture', '195 patients with hip fractures', 'elderly patients with hip fractures']","['innovative rehabilitation treatment', 'technology-assisted gait and balance training', 'traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View']","['risk of falling, gait performance and fear of falling']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",195.0,0.0345737,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Maranesi', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giovanni Renato', 'Initials': 'GR', 'LastName': 'Riccardi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Lattanzio', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Di Rosa', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Luzi', 'Affiliation': 'Medical Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Casoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rinaldi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baldoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Donna', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bevilacqua', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy r.bevilacqua@inrca.it.'}]",BMJ open,['10.1136/bmjopen-2019-035508'] 1958,32547735,Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.,"Background Surgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown. Methods The Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery. Results The study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46). Conclusions Observational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities. Trial registration The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.",2020,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"['Adult patients who underwent elective colorectal surgery', 'six Dutch hospitals', '39 patients had been randomized to active OAP and 39 to']","['OAP', 'colorectal surgery using oral non-absorbable antimicrobial prophylaxis', 'preoperative OAP with tobramycin and colistin or placebo', 'Oral non-absorbable antibiotic prophylaxis (OAP', 'placebo']","['infectious and non-infectious complications', 'incidence of deep SSI or mortality', 'relative risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.768962,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Kluytmans-van den Bergh', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Vlaminckx', 'Affiliation': 'Department of Medical Microbiology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'de Smet', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Vos Tot Nederveen Cappel', 'Affiliation': 'Department of Surgery, Admiraal de Ruyter Hospital, Goes, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Verheijen', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van der Vorm', 'Affiliation': 'Department of Medical Microbiology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bathoorn', 'Affiliation': 'Department of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacobien', 'Initials': 'J', 'LastName': 'Veenemans', 'Affiliation': 'Department of Medical Microbiology, Admiraal de Ruyter Hospital, Goes, the Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Weersink', 'Affiliation': 'Department of Medical Microbiology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Vos', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Clinical Pharmacy, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Nikolakopoulos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kluytmans', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00745-2'] 1959,32548906,Participation in a randomised controlled trial for older adults with osteoarthritis in Portugal: Analysis of the acceptance factors.,"Fit & Strong! is an evidence-based program that combines exercise with health education for older adults with lower extremity osteoarthritis. This paper explores the factors of acceptance to a randomised controlled trial that tested the Portuguese (Europe) version of Fit & Strong! and analysed the sociodemographic, lifestyle and health characteristics of people who agreed versus people who declined to participate. Patients were identified by General Practitioners at three healthcare centres during 4 months (May 2017 to July 2017). Patients who accepted the invitation and met the inclusion criteria are designated participants, and people who met the inclusion criteria, declined the opportunity to participate but agreed to answer a brief questionnaire are designated as non-participants. Data included sociodemographic, lifestyle behaviours, health, pain and ADLs from the Western Ontario and McMaster Universities Osteoarthritis. Data were analysed using descriptive analysis and the Wilcoxon-Mann-Whitney, Chi-Squared tests or Fisher's tests. The results showed that three out of 12 (25%) primary healthcare centres contacted about the new program accepted the invitation to participate in recruitment. Eighty-two patients were contacted, of whom 14 (17.2%) did not meet inclusion criteria and 32 (38.3%) met the inclusion criteria but declined to participate. The acceptance rate was 22%. Non-participants were older (U = 41.0; W = 212.0; p = .044) and experienced earlier osteoarthritis onset than participants (U = 26.0; W = 146.0; p = .031). In conclusion, younger age and a diagnosis of osteoarthritis more recent appear to predispose older adults with osteoarthritis to be more accepting of participation in a non-pharmacologic intervention designed to increase physical activity.",2020,Non-participants were older,"['older adults with lower extremity osteoarthritis', 'people who agreed versus people who declined to participate', 'Patients were identified by General Practitioners at three healthcare centres during 4\xa0months (May 2017 to July 2017', 'Eighty-two patients were contacted, of whom 14 (17.2%) did not meet inclusion criteria and 32 (38.3%) met the inclusion criteria but declined to participate', 'Non-participants were older', 'Patients who accepted the invitation and met the inclusion criteria are designated participants, and people who met the inclusion criteria, declined the opportunity to participate but agreed to answer a brief questionnaire are designated as non-participants', 'older adults with osteoarthritis in Portugal']",[],"['sociodemographic, lifestyle behaviours, health, pain and ADLs', 'acceptance rate', 'earlier osteoarthritis onset']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]",[],"[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",82.0,0.0537989,Non-participants were older,"[{'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Duarte', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Porto, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Santos', 'Affiliation': 'ICBAS, USF Argoncilhe, University of Porto, Porto, Portugal.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Community Health Sciences, School of Public Health and Director, Center for Research on Health and Aging, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Constança', 'Initials': 'C', 'LastName': 'Paúl', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Porto, Portugal.'}]",Health & social care in the community,['10.1111/hsc.13058'] 1960,32546269,Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE).,"BACKGROUND Most serious complications of infective endocarditis (IE) appear in the so-called ""critical phase"" of the disease, which represents the first days after diagnosis. The majority of patients overcoming the acute phase has a favorable outcome, yet they remain hospitalized for a long period of time mainly to complete antibiotic therapy. The major hypothesis of this trial is that in patients with clinically stable IE and adequate response to antibiotic treatment, without signs of persistent infection, periannular complications or metastatic foci, a shorter antibiotic time period would be as efficient and safe as the classic 4 to 6 weeks antibiotic regimen. METHODS Multicenter, prospective, randomized, controlled open-label, phase IV clinical trial with a non-inferiority design to evaluate the efficacy of a short course (2 weeks) of parenteral antibiotic therapy compared with conventional antibiotic therapy (4-6 weeks). SAMPLE patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients. INTERVENTION Control group: standard duration antibiotic therapy, (4 to 6 weeks) according to ESC guidelines recommendations. Experimental group: short-course antibiotic therapy for 2 weeks. The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared. CONCLUSIONS SATIE will investigate whether a two weeks short-course of intravenous antibiotics in patients with IE caused by gram-positive cocci, without signs of persistent infection, is not inferior in safety and efficacy to conventional antibiotic treatment (4-6 weeks). TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04222257 (January 7, 2020). EudraCT 2019-003358-10.",2020,"The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared. ","['Estimated sample size: 298 patients', 'gram-positive cocci infective endocarditis']","['conventional antibiotic treatment', 'conventional antibiotic therapy', 'Control group: standard duration antibiotic therapy', 'parenteral antibiotic therapy']","['cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses']","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018155', 'cui_str': 'Gram-positive coccus'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.161137,"The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared. ","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Olmos', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain. carmen.olmosblanco@gmail.com.'}, {'ForeName': 'Isidre', 'Initials': 'I', 'LastName': 'Vilacosta', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'López', 'Affiliation': 'Servicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Sáez', 'Affiliation': 'Servicio de Medicina Interna-Infecciosas, Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Anguita', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Pablo Elpidio', 'Initials': 'PE', 'LastName': 'García-Granja', 'Affiliation': 'Servicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sarriá', 'Affiliation': 'Servicio de Medicina Interna-Infecciosas, Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Silva', 'Affiliation': 'Servicio de Cirugía Cardiaca, Hospital Universitario Central de Oviedo, Oviedo, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Álvarez-Álvarez', 'Affiliation': 'Servicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'María Amparo', 'Initials': 'MA', 'LastName': 'Martínez-Monzonis', 'Affiliation': 'Servicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Castillo', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Seijas', 'Affiliation': 'Servicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'López-Picado', 'Affiliation': 'Unidad de Investigación y Ensayos Clinicos. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Peral', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Maroto', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain.'}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'San Román', 'Affiliation': 'Servicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.'}]",BMC infectious diseases,['10.1186/s12879-020-05132-1'] 1961,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279'] 1962,32544925,Selective kappa-opioid antagonism ameliorates anhedonic behavior: evidence from the Fast-fail Trial in Mood and Anxiety Spectrum Disorders (FAST-MAS).,"Anhedonia remains a major clinical issue for which there is few effective interventions. Untreated or poorly controlled anhedonia has been linked to worse disease course and increased suicidal behavior across disorders. Taking a proof-of-mechanism approach under the auspices of the National Institute of Mental Health FAST-FAIL initiative, we were the first to show that, in a transdiagnostic sample screened for elevated self-reported anhedonia, 8 weeks of treatment with a kappa-opioid receptor (KOR) antagonist resulted in significantly higher reward-related activation in one of the core hubs of the brain reward system (the ventral striatum), better reward learning in the Probabilistic Reward Task (PRT), and lower anhedonic symptoms, relative to 8 weeks of placebo. Here, we performed secondary analyses of the PRT data to investigate the putative effects of KOR antagonism on anhedonic behavior with more precision by using trial-level model-based Bayesian computational modeling and probability analyses. We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback). Collectively, these findings provide novel evidence that in a transdiagnostic sample characterized by elevated anhedonia, KOR antagonism improved the ability to modulate behavior as a function of prior rewards. Together with confirmation of target engagement in the primary report (Krystal et al., Nat Med, 2020), the current findings suggest that further transdiagnostic investigation of KOR antagonism for anhedonia is warranted.",2020,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).",[],"['placebo, KOR antagonism', 'KOR antagonism', 'placebo']","['learning rate (i.e., ability to learn from reward feedback']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064239', 'cui_str': 'kappa Opioid Receptor'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0633681,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).","[{'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA. dap@mclean.harvard.edu.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Smoski', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'School of Medical Sciences, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nurnberger', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Weiner', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Goodman', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0738-4'] 1963,32558199,Avoidance of CNI and Steroids Using Belatacept - Results of the Clinical Trials in Organ Transplantation 16 Trial.,"Immunosuppression devoid of corticosteroids has been investigated to avoid long term comorbidities. Likewise, alternatives to calcineurin inhibitors have been investigated as a strategy to improve long-term kidney function following transplanion. Costimulatory blockade strategies that include corticosteroids have recently shown promise, despite their higher rates of early acute rejection. We designed a randomized clinical trial utilizing depletional induction therapy to mitigate early rejection risk while limiting calcineurin inhibitors and corticosteroids. This trial, CTOT-16, sought to evaluate novel belatacept-based strategies employing tacrolimus and corticosteroid avoidance. 69 kidney transplant recipients were randomized from 4 US transplant centers comparing a control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to two arms using maintenance belatacept. There were no graft losses but there were 2 deaths in the control group. However, the trial was halted early due to rejection in the belatacept treatment groups. Serious adverse events were similar across groups. While rejection was not uniform in the belatacept maintenance therapy groups, the frequency of rejection limits the practical implementation of this strategy to avoid both calcineurin inhibitors and corticosteroids at this time.",2020,Serious adverse events were similar across groups.,['69 kidney transplant recipients'],"['depletional induction therapy', 'control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to two arms using maintenance belatacept', 'tacrolimus and corticosteroid avoidance', 'calcineurin inhibitors and corticosteroids']","['graft losses', 'Serious adverse events']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",69.0,0.102752,Serious adverse events were similar across groups.,"[{'ForeName': 'Roslyn B', 'Initials': 'RB', 'LastName': 'Mannon', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho, Durham, North Carolina, United States.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, United States.'}, {'ForeName': 'Alton B', 'Initials': 'AB', 'LastName': 'Farris', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, United States.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Watson', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Minnie', 'Initials': 'M', 'LastName': 'Sarwal', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sigdel', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bridges', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robien', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Newell', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, United States.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Larsen', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, United States.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16152'] 1964,32552707,Correlation of binocular refractive error and calculation of intraocular Lens power for the second eye.,"BACKGROUND Reducing refractive error has always been a tricky problem. The aim of this study was to verify the correlation between binocular refractive error (RE) after sequential cataract surgery and explore an individualized calculation method of intraocular lens (IOL) for the second eye. METHODS This was a prospective study. One hundred eighty-eight affected eyes in 94 age-related cataract patients who underwent sequential cataract surgery in the Department of Ophthalmology, Tangdu Hospital, China, were recruited. Complete case data were included for a correlation analysis of binocular RE. Data obtained in patients with RE values greater than 0.50 diopters (D) in the first eye were extracted and the patients divided randomly into two groups: Group A and B. In the adjustment group, group A, we modified the IOL power for the second eyes as 50% of the RE of the first eye. In group B, the control group, there was no modification. The mean absolute refractive error (MARE) values of the second eyes were evaluated one month after surgery. RESULTS The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001). After the IOL power of the second eyes was adjusted, the MARE of the second eyes was 0.57 ± 0.41 D, while the MARE of the first eyes was 1.18 ± 0.85 D, and the difference was statistically significant (P < 0.001). CONCLUSIONS Binocular REs were positively correlated after sequential cataract surgery. The RE of the second eye can be reduced by adjusting the IOL power based on 50% of the postoperative RE of the first eye.",2020,The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001).,"['One hundred eighty-eight affected eyes in 94 age-related cataract patients who underwent sequential cataract surgery in the Department of Ophthalmology, Tangdu Hospital, China, were recruited', 'patients with RE values greater than 0.50 diopters (D) in the first eye']",['sequential cataract surgery and explore an individualized calculation method of intraocular lens (IOL'],"['binocular refractive error (RE', 'IOL power', 'mean absolute refractive error (MARE) values', 'binocular RE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}]","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0429521', 'cui_str': 'Intraocular lens power'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",188.0,0.0263921,The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001).,"[{'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Fourth Hospital, Shaanxi Eye Hospital, Affiliated Xi'an Fourth Hospital, Northwestern Polytechnical University, Xi'an, 710004, Shaanxi Province, China.""}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Tangdu Hospital, Fourth Military Medical University, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Xi'an Fourth Hospital, Shaanxi Eye Hospital, Affiliated Xi'an Fourth Hospital, Northwestern Polytechnical University, Xi'an, 710004, Shaanxi Province, China. yan2128ts@hotmail.com.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Tangdu Hospital, Fourth Military Medical University, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Ophthalmology, University of Heidelberg, 69120, Heidelberg, Germany.'}]",BMC ophthalmology,['10.1186/s12886-020-01496-9'] 1965,32552711,Effect of symmetrical restoration for the migration of uncemented total hip arthroplasty: a randomized RSA study with 75 patients and 5-year follow-up.,"BACKGROUND Inferior placement of a femoral stem is predictive for early loosening and failure, but does restoration of the original hip anatomy benefit the function and survival of a total hip replacement? METHODS Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem were randomized for either standard or modular stems. We used 50 ABG II stems with modular necks and 25 standard stems (control group). We measured the symmetry in hip anatomy between healthy and operated side. The anatomical restoration variables were anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota. We performed measurements using a CT-based 3D templating and measuring software. Migratory behavior of the stems was then measured postoperatively with repeated radiostereometry (RSA) examinations over 5 years. RESULTS Both stem types showed an early (within 3 months) good stabilization after an initial slight rotation into retroversion and subsidence. There were no significant differences in RSA migration between modular and standard stems. Postoperative anteversion and FO/AO quota had no impact on stem migration. The standard stem tended to result in insufficient global offset (GO), whereas the modular stem did not. CONCLUSIONS The modular stem gave good symmetrical anatomical restoration and, like the standard version, a benign migratory behavior. Anteversion, GO, and FO/AO quota had no significant impact on stem migration. It therefore seems to be of no importance whether we choose a modular or a standard stem with regard to postoperative stem migration for this stem type. We overestimated the effect anatomical parameters have on stem movement; hence, we believe the study to be underpowered. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01512550. Registered 19 January 2012-retrospectively registered.",2020,There were no significant differences in RSA migration between modular and standard stems.,"['uncemented total hip arthroplasty', 'hip anatomy between healthy and operated side', 'Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem', '75 patients and 5-year follow-up']","['standard or modular stems', 'symmetrical restoration']","['RSA migration', 'stem migration', 'anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",75.0,0.0588382,There were no significant differences in RSA migration between modular and standard stems.,"[{'ForeName': 'Sverrir', 'Initials': 'S', 'LastName': 'Kiernan', 'Affiliation': 'Department of Orthopedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden. Sverrir.Kiernan@med.lu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Geijer', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundberg', 'Affiliation': 'Department of Orthopedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Department of Orthopedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01736-0'] 1966,32552731,Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial.,"BACKGROUND Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM). However, whether acupuncture can effectively treat fibromyalgia is currently unclear. Therefore, we aim to design a study protocol of a randomized controlled clinical trial and assess the effectiveness of acupuncture for patients with fibromyalgia, which may lead to alleviation of clinical symptoms and improvement of patients' quality of life. METHODS The study is designed as a randomized, blinded, placebo-controlled trial of two cohorts conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Shenzhen Traditional Chinese Medicine Hospital, respectively. A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups. All subjects will receive acupuncture intervention for 8 weeks with follow-up assessments every 4 weeks for 16 weeks. The primary outcome will be evaluated using the visual analogue scale (VAS) and revised fibromyalgia impact questionnaire (FIQR) for pain intensity. The secondary outcome measures will include: Multidimensional Assessment of Fatigue scale (MAF), Short Form-36 (SF-36), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Chinese perceived stress scales (pss-14), changes in the number of 18 tender points, patient satisfaction for the treatment and adverse events. The mentioned outcome measurements will be assessed every 4 weeks for 6 months. DISCUSSION This clinical trial will use advanced research methods to evaluate the efficacy and safety of acupuncture on fibromyalgia. The results of this trial may provide clinical evidence on the beneficial effects of acupuncture in treating fibromyalgia. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1800016826: AMCTR-IOR-18000184. Registered 27 June 2018, http://www.acmctr.org/listbycreater.aspx.",2020,"A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups.","[""two cohorts conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Shenzhen Traditional Chinese Medicine Hospital, respectively"", 'patients with fibromyalgia', '68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria', 'primary fibromyalgia']","['acupuncture', 'acupuncture intervention', 'acupuncture or sham acupuncture', 'Acupuncture', 'placebo']","['efficacy and safety', 'visual analogue scale (VAS) and revised fibromyalgia impact questionnaire (FIQR) for pain intensity', ' Multidimensional Assessment of Fatigue scale (MAF), Short Form-36 (SF-36), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Chinese perceived stress scales (pss-14), changes in the number of 18 tender points, patient satisfaction for the treatment and adverse events']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0751152', 'cui_str': 'Primary fibromyalgia syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4041113', 'cui_str': 'Assessment of fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",68.0,0.50294,"A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups.","[{'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jiakang', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.'}, {'ForeName': 'Donghong', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qiuwei', 'Initials': 'Q', 'LastName': 'Peng', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Beijing CreateMed Medicine Technology Co., LTD, Beijing, China.'}, {'ForeName': 'Xiaopo', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. 13823396319@163.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. jiang.quan@hotmail.com.""}]",Trials,['10.1186/s13063-020-04317-y'] 1967,32552775,"The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation.","BACKGROUND Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation. METHODS A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits. RESULTS All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05). CONCLUSIONS When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking. TRIAL REGISTRATION NCT03499210. Prospectively registered on March 28, 2018.",2020,Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis.,"['users with post-stroke hemiparesis', '44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground']",['exosuit-augmented post-stroke gait rehabilitation'],"['safety and reliability evaluations', 'mobility, health, and quality of life', 'gait mechanics and energetics and faster and farther walking', 'No device-related falls or serious adverse events', 'maximum walking speeds', ""safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds""]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040606', 'cui_str': 'Training Activities'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",44.0,0.124064,Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis.,"[{'ForeName': 'Louis N', 'Initials': 'LN', 'LastName': 'Awad', 'Affiliation': 'Department of Physical Therapy & Athletic Training, Boston University, Boston, MA, USA. louawad@bu.edu.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of PM&R, MossRehab and Einstein Healthcare Network, Elkins Park, PA, USA.'}, {'ForeName': 'Gerard E', 'Initials': 'GE', 'LastName': 'Francisco', 'Affiliation': 'Department of PM&R, University of Texas McGovern Medical School, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Nolan', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Jayaraman', 'Affiliation': 'Department of PM&R, Northwestern University, Chicago, IL, USA. ajayaraman@sralab.org.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00702-5'] 1968,32553888,Effect of practical hyperoxic high-intensity interval training on exercise performance.,"This study investigated the effect of a practical hyperoxic high-intensity interval training (HIIT) on aerobic and anaerobic exercise capacity. Sixteen male athletes were randomized into 2 groups: normoxic HIIT (NHIIT, n = 8) group or hyperoxic HIIT (HHIIT, n = 8) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia. All training sessions were performed until exhaustion. Participants performed maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests before and after the training period. Maximal oxygen uptake (P < 0.01) increased significantly in both groups. Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01). Mean power output during maximal exercise increased significantly only in the HHIIT group (P = 0.02). This study demonstrated that a practical hyperoxic HHIIT might be effective for improving aerobic capacity and anaerobic performance.",2020,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,['Sixteen male athletes'],"['normoxic HIIT (NHIIT, n\u2009=\u20098) group or hyperoxic HIIT (HHIIT, n\u2009=\u20098) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia', 'maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests', 'practical hyperoxic high-intensity interval training', 'practical hyperoxic high-intensity interval training (HIIT']","['Mean power output during maximal exercise', 'Blood lactate curve during submaximal exercise', 'Maximal oxygen uptake', 'aerobic capacity and anaerobic performance', 'aerobic and anaerobic exercise capacity', 'exercise performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",16.0,0.0253253,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,"[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, 101-2 Yagotohonmachi, Showa-ku, Nagoya, 466-8666, Japan; Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan. Electronic address: kon.michihiro@gmail.com.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nakagaki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan; Department of Sports Sciences, Yamanashi Gakuin University, 2-4-5 Sakaori, Kofu, Yamanashi, 400-8575, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Ebi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103481'] 1969,32553922,Conditioning automatic inhibition task: Introducing a novel task to associate automatic inhibition with specific cues.,"There is growing interest in methods for conditioning automatic inhibition with specific stimuli and the potential clinical implications of these methods. For example, OCD patients were shown to benefit from a computerized training program which aimed to create an association between OCD-related cues and stopping behaviors. In the current study, we aimed to investigate the ability to condition inhibition to specific stimuli and whether such conditioning can be generalized between tasks to last over time. Participants completed 6 training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT), over a 48 -h period, in which one randomly chosen color patch was associated with inhibition. The classic Stroop task was administered before and after the CAIT training. Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping. These results demonstrate the effect of the CAIT onto one specific stimulus, and that the effect generalized between the training and testing tasks. This provides novel evidence that the CAIT can be used to facilitate faster recruitment of inhibitory resources for a specific trained stimulus, which might later help resolve cognitive conflicts that require inhibition and might also have important clinical implications.",2020,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.",[],"['Conditioning Automatic Inhibition Task', ""training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT""]",['smaller congruency and interference effects'],[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",1.0,0.0185002,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.","[{'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Hochman', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, The Hebrew University of Jerusalem, Israel. Electronic address: shacharh@post.bgu.ac.il.'}, {'ForeName': 'Shahaf', 'Initials': 'S', 'LastName': 'Leshem', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Avishai', 'Initials': 'A', 'LastName': 'Henik', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}]",Journal of neuroscience methods,['10.1016/j.jneumeth.2020.108809'] 1970,32553932,The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.,"BACKGROUND The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years. METHODS STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial. DISCUSSION The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.",2020,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"['older STEMI patients who cannot undergo timely pPCI', '300 patients', 'older ST-elevation myocardial infarction patients', 'Approximately 600 patients', 'STEMI patients ≥60 years presenting within 3 hours from symptom onset', 'patients presenting early with ST-elevation myocardial infarction (STEMI']",['novel pharmaco-invasive strategy'],"['intracranial hemorrhage (ICH', 'bleeding events', 'efficacy and safety']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.0767294,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Emergency Department and SAMU, Lille University Hospital, Lille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Pages', 'Affiliation': 'Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'TDC, Aix en Provence, France.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: frans.vandewerf@kuleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.029'] 1971,32566377,INCORPORATING A DUAL-TASK ASSESSMENT PROTOCOL WITH FUNCTIONAL HOP TESTING.,"Background Hop tests are commonly used within a testing battery to assess readiness for return to sport after anterior cruciate ligament (ACL) injury, yet athletes still experience a high rate of re-injury. Simultaneous performance of a secondary task requiring cognitive processing or decision-making may test the athlete under more realistic contexts. Purpose To examine a clinically feasible, dual-task assessment paradigm applied during functional hop tests in healthy individuals. Study Design Repeated measures. Methods Participants performed the crossover triple hop for distance (XHOP) and medial triple hop for distance test (MHOP) under three separate conditions: standard procedures and two dual-task protocols including the backward digit span memory task and a visuospatial recognition task. The visuospatial task involved briefly displaying an image consisting of 18 randomly placed red and blue circles on a screen, where the participant was asked to identify the number of red circles in each image. The backward digit span task was applied by introducing a sequence of random numbers to the participants, who were required to repeat the sequence in reverse order. Each motor and cognitive task was performed independently and simultaneously, in accordance with the dual-task paradigm. Results Thirty-four healthy participants (age: 24.0 ± 3.9 years) completed testing procedures. No differences in hop distance were observed with the simultaneous application of a cognitive task, with the exception of the backward digit span memory task resulting in decreased hop distance (p = 0.04, d = 0.14). There were no differences in cognitive accuracy according to hop test type, although the effect size was greater for the XHOP (p = 0.08, d = 0.49) compared to the MHOP (p = 1.0, d = 0.07). The dual-task protocol revealed good-excellent within- (ICC3,1 = 0.85 - 0.99) and between-session (ICC3,k = 0.94 - 0.99) intrarater reliability for hop distance across all dual-task conditions. The addition of a cognitive task to the XHOP and MHOP resulted in a lower standard error of measurement and decreased minimal detectable change, as compared to standard testing procedures. Conclusion The simultaneous application of a cognitive task did not alter hop distance, with the exception of the backward digit span memory task resulting in decreased hop distance with a trivial effect size. There were no differences in cognitive accuracy according to task type (sitting, XHOP, MHOP). All combinations of dual-task assessment demonstrated good-excellent within- and between-session intrarater reliability among healthy individuals, but measurement precision was deficient. Level of Evidence 2b.",2020,"The simultaneous application of a cognitive task did not alter hop distance, with the exception of the backward digit span memory task resulting in decreased hop distance with a trivial effect size.","['Results\n\n\nThirty-four healthy participants (age: 24.0\u2009±\u20093.9 years) completed testing procedures', 'healthy individuals']",['crossover triple hop for distance (XHOP) and medial triple hop for distance test (MHOP) under three separate conditions: standard procedures and two dual-task protocols including the backward digit span memory task and a visuospatial recognition task'],"['cognitive accuracy', 'cognitive accuracy according to task type (sitting, XHOP, MHOP', 'backward digit span memory task', 'visuospatial task']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",34.0,0.0206032,"The simultaneous application of a cognitive task did not alter hop distance, with the exception of the backward digit span memory task resulting in decreased hop distance with a trivial effect size.","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, Vermillion, SD, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, Vermillion, SD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, La Crosse, WI, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Schweinle', 'Affiliation': 'Department of Physician Assistant Studies, University of South Dakota, Vermillion, SD, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schweinle', 'Affiliation': 'School of Education Research Center, University of South Dakota, Vermillion, SD, USA.'}]",International journal of sports physical therapy,[] 1972,32566501,Correlation between corneal demarcation line depth in epithelium-off and trans-epithelium accelerated corneal cross linking and keratoconus progression.,"AIM To compare corneal demarcation line (DL) depth in both accelerated epithelium-off and trans-epithelium cross linking (CXL) using anterior segment optical coherence tomography (AS-OCT) and its relation to maximum keratometry (Kmax) progression in both techniques. METHODS A prospective comparative interventional study where patients with mild to moderate keratoconus (KC) were classified into two groups: accelerated epithelium-off and trans-epithelium CXL based on corneal pachymetry. Assessment of corneal DL depth was carried out after 3mo by AS-OCT. Kmax readings were evaluated after one year follow up using the Scheimpflug imaging system. RESULTS Study included 74 eyes of 44 patients. Group A underwent epithelium-off CXL (41 eyes), while Group B underwent trans-epithelium CXL (33 eyes). At 3mo follow up, mean corneal DL depth in Group A was 219.9±58.4 µm while in Group B was 127.2±7.8 µm ( P <0.05). The mean Kmax changed from 51.9±3.9 to 51.3±4.2 diopters in Group A and from 53.1±4.1 to 53.6±5 diopters in Group B with insignificant difference in Kmax changes in either group ( P >0.05). In addition, no significant change in corneal pachymetry was found in both groups (mean change at 1y: 6.4±4.7 and -10.1±2.3 µm in Groups A and B respectively). CONCLUSION Despite a significantly deeper corneal DL depth created by accelerated epithelium-off CXL technique compared to accelerated trans-epithelium CXL, there is no significant impact on keratoconus progression.",2020,"At 3mo follow up, mean corneal DL depth in Group A was 219.9±58.4 µm while in Group B was 127.2±7.8 µm ( P <0.05).","['patients with mild to moderate keratoconus (KC', 'Study included 74 eyes of 44 patients']","['accelerated trans-epithelium CXL', 'accelerated epithelium-off and trans-epithelium CXL', 'epithelium-off CXL (41 eyes), while Group B underwent trans-epithelium CXL', 'anterior segment optical coherence tomography (AS-OCT']","['corneal pachymetry', 'corneal DL depth', 'Kmax changes', 'corneal demarcation line (DL) depth', 'mean corneal DL depth', 'mean Kmax', 'Kmax readings', 'keratoconus progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C0412514', 'cui_str': 'Corneal pachymetry'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",74.0,0.0165248,"At 3mo follow up, mean corneal DL depth in Group A was 219.9±58.4 µm while in Group B was 127.2±7.8 µm ( P <0.05).","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abdel-Radi', 'Affiliation': 'Department of Ophthalmology, Assiut University, Assiut 71516, Egypt.'}, {'ForeName': 'Zeiad', 'Initials': 'Z', 'LastName': 'Eldaly', 'Affiliation': 'Department of Ophthalmology, Assiut University, Assiut 71516, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Abdelmotaal', 'Affiliation': 'Department of Ophthalmology, Assiut University, Assiut 71516, Egypt.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Ophthalmology, Assiut University, Assiut 71516, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sayed', 'Affiliation': 'Department of Ophthalmology, Assiut University, Assiut 71516, Egypt.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Soliman', 'Affiliation': 'Department of Ophthalmology, Assiut University, Assiut 71516, Egypt.'}]",International journal of ophthalmology,['10.18240/ijo.2020.06.08'] 1973,32566502,Rainbow halos occur less following implantation of extended range of vision one-piece intraocular lenses vs diffractive bifocal intraocular lenses.,"AIM To evaluate clinical outcomes following implantation of an extended range of vision intraocular lens (IOL), the ZXR00, and a diffractive multifocal IOL with +2.75 diopters (D) add power, the ZKB00. METHODS Totally 30 patients who underwent either bilateral implantation of the ZXR00 IOL with intended emmetropia (ZXR00 emmetropia group: 20 eyes) and intended micromonovision (ZXR00 monovision group: 20 eyes), or bilateral implantation of the ZKB00 IOL with intended emmetropia (ZKB00 group: 20 eyes) were included in this study. Visual acuity at 4 m, 80, and 40 cm; and the types of halos (misty, fine, and rainbow) were analyzed at one and three months after surgery. RESULTS There were no significant differences in distance visual acuity among the three groups. The mean uncorrected intermediate visual acuity was better in the ZXR00 emmetropia and monovision groups (0.02 logMAR and 0.02 logMAR, respectively) than in the ZKB00 group (0.14 logMAR). The mean uncorrected near visual acuity was worse in the ZXR00 emmetropia group (0.26 logMAR) than in the ZXR00 monovision and ZKB00 groups (0.12 logMAR and 0.10 logMAR, respectively). There was an increased incidence of rainbow halos in the ZKB00 group vs in either ZXR00 group ( P =0.033). CONCLUSION Implantation of the ZXR00 IOL with intended micromonovision provide superior visual acuity than implantation of the ZXR00 IOL with intended emmetropia. The ZXR00 IOLs tend to show a lower incidence of rainbow halos than did the ZKB00 IOL.",2020,"There was an increased incidence of rainbow halos in the ZKB00 group vs in either ZXR00 group ( P =0.033). ","['group: 20 eyes', 'Totally 30 patients who underwent either bilateral implantation of the']","['ZXR00 IOL with intended emmetropia (ZXR00 emmetropia group: 20 eyes) and intended micromonovision (ZXR00 monovision group: 20 eyes), or bilateral implantation of the ZKB00 IOL with intended emmetropia (ZKB00', 'ZXR00', 'vision intraocular lens (IOL', 'ZKB00']","['mean uncorrected intermediate visual acuity', 'distance visual acuity', 'mean uncorrected near visual acuity', 'types of halos (misty, fine, and rainbow', 'Visual acuity', 'incidence of rainbow halos']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042797', 'cui_str': 'Monocular vision'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}]",30.0,0.110812,"There was an increased incidence of rainbow halos in the ZKB00 group vs in either ZXR00 group ( P =0.033). ","[{'ForeName': 'Jae-Hyung', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Seoul Daabom Eye Center, Cheongju 28568, Republic of Korea.'}, {'ForeName': 'Youngsub', 'Initials': 'Y', 'LastName': 'Eom', 'Affiliation': 'Department of Ophthalmology, Ansan Hospital, Korea University College of Medicine, Seoul 15355, Republic of Korea.'}, {'ForeName': 'Seo Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, Ansan Hospital, Korea University College of Medicine, Seoul 15355, Republic of Korea.'}, {'ForeName': 'Soo Youn', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Ophthalmology, Ansan Hospital, Korea University College of Medicine, Seoul 15355, Republic of Korea.'}, {'ForeName': 'Ho Sik', 'Initials': 'HS', 'LastName': 'Hwang', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul 07345, Republic of Korea.""}, {'ForeName': 'Jun-Heon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Joeunnun Vision Clinic, Seoul 06134, Republic of Korea.'}, {'ForeName': 'Jong Suk', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Ansan Hospital, Korea University College of Medicine, Seoul 15355, Republic of Korea.'}, {'ForeName': 'Hyo Myung', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Ansan Hospital, Korea University College of Medicine, Seoul 15355, Republic of Korea.'}]",International journal of ophthalmology,['10.18240/ijo.2020.06.09'] 1974,32566763,A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.,"Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health. We investigated the effectiveness and cost-effectiveness of iCBT when fully integrated within IAPT stepped-care settings. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: waiting-list) allocation, for participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration: ISRCTN91967124). The primary outcomes measures were PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment) as a secondary outcome. The cost-effectiveness analysis was based on EQ-5D-5L (preference-based health status) to elicit the quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use). Diagnostic interviews were administered at baseline and 3 months. Three-hundred and sixty-one participants were randomized (iCBT, 241; waiting-list, 120). Intention-to-treat analyses showed significant interaction effects for the PHQ-9 ( b  = -2.75, 95% CI -4.00, -1.50) and GAD-7 ( b  = -2.79, 95% CI -4.00, -1.58) in favour of iCBT at 8-week and further improvements observed up to 12-months. Over 8-weeks the probability of cost-effectiveness was 46.6% if decision makers are willing to pay £30,000 per QALY, increasing to 91.2% when the control-arm's outcomes and costs were extrapolated over 12-months. Results indicate that iCBT for depression and anxiety is effective and potentially cost-effective in the long-term within IAPT. Upscaling the use of iCBT as part of stepped care could help to enhance IAPT outcomes. The pragmatic trial design supports the ecological validity of the findings.",2020,"Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health.","['Three-hundred and sixty-one participants', 'participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration']","['digital interventions', '2:1 (iCBT intervention: waiting-list) allocation', 'internet-delivered cognitive behavioural therapy (iCBT', 'iCBT']","['probability of cost-effectiveness', 'PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment', 'quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use', 'GAD-7', 'depression and anxiety']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",361.0,0.15685,"Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Eilert', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'HEDS, ScHARR, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Palacios', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duffy', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Earley', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire, England.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Jell', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire, England.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sollesse', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire, England.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Timulak', 'Affiliation': 'Clinical Research & Innovation, SilverCloud Health, Dublin, Ireland.'}]",NPJ digital medicine,['10.1038/s41746-020-0293-8'] 1975,32566796,The effect of normalization of sodium on bone turnover markers in patients with epilepsy. A randomized single-blinded placebo-controlled trial.,"Hyponatremia [p[Na]<136 mmol/L] is an independent risk factor for decreased bone mineral density (BMD). However, whether hyponatremia represents a surrogate marker, or a direct causal relationship to bone loss remains unknown. The aim of the study was to investigate the effect of salt replacement therapy on bone turnover markers (BTM) and BMD in patients with epilepsy and chronic hyponatremia. This prospective single-blinded randomized trial investigated serum BTM and BMD, evaluated by Dual Energy X-ray Absorptiometry (DXA), in 21 patients at baseline and following three months of salt replacement therapy. Patients with two consecutive measurements of hyponatremia prior to baseline and no known osteoporosis were included from the epilepsy out-patient clinic at Rigshospitalet, Denmark. Seven patients were randomized to placebo and 14 to salt intervention. The baseline p[Na] was 134 (130.5-140) mmol/L (median (IQR)). All patients had BTM within age-specific reference ranges at baseline. Following 3 months of intervention with 3-9 g of salt daily there was no difference in levels of procollagen type 1 N-terminal propeptide (P1NP) or C-terminal cross-linking telopeptide of type 1 collagen (CTX) between placebo and intervention. Nor was there any difference in BMD evaluated at the lumbar spine (L 1 -L 4 ) or at the femoral neck or total hip. In our study, salt replacement did neither affect BTM nor BMD. However, due to the small size of the study, more studies are needed to further investigate this.",2020,Following 3 months of intervention with 3-9 g of salt daily there was no difference in levels of procollagen type 1 N-terminal propeptide (P1NP) or C-terminal cross-linking telopeptide of type 1 collagen (CTX) between placebo and intervention.,"['21 patients at baseline and following three months of salt replacement therapy', 'patients with epilepsy', 'patients with epilepsy and chronic hyponatremia', 'Patients with two consecutive measurements of hyponatremia prior to baseline and no known osteoporosis were included from the epilepsy out-patient clinic at Rigshospitalet, Denmark']","['Hyponatremia [p[Na]<136\xa0mmol/L', 'sodium', 'salt replacement therapy', 'serum BTM and BMD, evaluated by Dual Energy X-ray Absorptiometry (DXA', 'placebo']","['BTM nor BMD', 'BMD', 'bone turnover markers (BTM) and BMD', 'bone mineral density (BMD', 'bone turnover markers', 'levels of procollagen type 1\xa0N-terminal propeptide (P1NP) or C-terminal cross-linking telopeptide of type 1 collagen (CTX']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0268007', 'cui_str': 'Chronic hyponatremia'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",7.0,0.246791,Following 3 months of intervention with 3-9 g of salt daily there was no difference in levels of procollagen type 1 N-terminal propeptide (P1NP) or C-terminal cross-linking telopeptide of type 1 collagen (CTX) between placebo and intervention.,"[{'ForeName': 'Sarah Seberg', 'Initials': 'SS', 'LastName': 'Diemar', 'Affiliation': 'Department of Neurology, Rigshospitalet Glostrup, Valdemar Hansens Vej 1-23, 2600, Glostrup, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'OPEN, Open Patient Data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, J. B. Winsløws Vej 19, 5000, Odense C, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Eiken', 'Affiliation': 'Department of Endocrinology and Nephrology, Nordsjællands Hospital, Dyrehavevej 29, 3400, Hillerød, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Suetta', 'Affiliation': 'Geriatric Research Unit, Department of Internal Medicine, Herlev-Gentofte Hospital, Herlev Ringvej 75, 2720, Herlev, Denmark.'}, {'ForeName': 'Noémi Becser', 'Initials': 'NB', 'LastName': 'Andersen', 'Affiliation': 'Department of Neurology, Rigshospitalet Glostrup, Valdemar Hansens Vej 1-23, 2600, Glostrup, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Sejling', 'Affiliation': 'Department of Endocrinology and Nephrology, Nordsjællands Hospital, Dyrehavevej 29, 3400, Hillerød, Denmark.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100587'] 1976,32566897,Efficacy of a new Activation Device in Irrigant Penetration Into Simulated Lateral Canals.,"Objective The aim of the present study was to compare the effects of EasyClean (EC) on irrigant delivery into simulated lateral canals using an artificial closed canal system. Passive ultrasonic irrigation (PUI) was used as a reference technique for comparison. Methods Forty simulated curved root canals manufactured in transparent resin and with simulated lateral canals were instrumented with Reciproc R40 files and randomly assigned to four groups (n=10) according to the irrigant activation technique: PUI group, ECrec group (EC used in reciprocating motion), ECrot group (EC used in rotary motion), and control group (no activation performed). After activation, stereomicroscope images from each block were taken, and irrigant penetration into lateral canals was measured using Adobe Photoshop software. Data were analysed using ANOVA and Tukey's post hoc test (α=0.05). Results No penetration was observed in the control group. The ECrec group showed lower penetration than the other group (P<0.05). No differences were observed between the ECrot group and the PUI group (P>0.05). Conclusion EC used in rotary motion was effective in increasing the penetration of the irrigating solution into simulated lateral canals.",2016,The ECrec group showed lower penetration than the other group (P<0.05).,['Methods\n\n\nForty simulated curved root canals manufactured in transparent resin and with simulated lateral canals were instrumented with Reciproc R40 files and randomly assigned to four groups (n=10) according to the'],"['irrigant activation technique: PUI group, ECrec group (EC used in reciprocating motion), ECrot group (EC used in rotary motion), and control group (no activation performed', 'Passive ultrasonic irrigation (PUI', 'EasyClean (EC', 'new Activation Device']",['lower penetration'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0449263', 'cui_str': 'Activation technique'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]",40.0,0.0150494,The ECrec group showed lower penetration than the other group (P<0.05).,"[{'ForeName': 'Carlos Vieira', 'Initials': 'CV', 'LastName': 'Andrade-Junior', 'Affiliation': 'Department of Endodontics, Southwestern Bahia State University (UESB), Jequié, Brazil.'}, {'ForeName': 'Rafaela M', 'Initials': 'RM', 'LastName': 'Batista', 'Affiliation': 'Department of Endodontics, Southwestern Bahia State University (UESB), Jequié, Brazil.'}, {'ForeName': 'Marilia', 'Initials': 'M', 'LastName': 'Marceliano-Alves', 'Affiliation': 'Department of Endodontics, Estácio de Sá University (UNESA), Rio de Janeiro, Brazil.'}, {'ForeName': 'Flávio Rodrigues Ferreira', 'Initials': 'FRF', 'LastName': 'Alves', 'Affiliation': 'Department of Endodontics, Estácio de Sá University (UNESA), Rio de Janeiro, Brazil.'}, {'ForeName': 'Emmanuel João Nogueira Leal', 'Initials': 'EJNL', 'LastName': 'Silva', 'Affiliation': 'Department of Endodontics, Grande Rio University (UNIGRANRIO), Rio de Janeiro, Brazil.'}]",European endodontic journal,['10.5152/eej.2016.16003'] 1977,32566900,Comparison of the Effectiveness of Different Techniques for Supportive Removal of Root Canal Filling Material.,"Objective To compare the cleanliness of oval cross-sectioned root canals after using different supportive techniques for removal of root canal filling material as part of retreatment process. Methods One hundred mandibular canine teeth with flat oval cross-sectioned canals were instrumented up to #40.06 and obturated using the warm vertical compaction technique. Removal of the gutta-percha and sealer was performed using the D-RaCe nickel-titanium retreatment instruments. The roots were randomly divided into four groups of 25 teeth, and the activation processes were applied: XP-endo Finisher (XP), EndoActivator (EA) and IrrıSafe (IS). Conventional needle irrigation (CI) was used as the control group. The teeth were sectioned, and digital images were captured. The photographs were analysed using AutoCAD software regarding the area of residual root filling. Kruskal-Wallis and post hoc Dunn's tests were performed for statistical analysis. Results There was significantly less gutta-percha and sealer remnant in the XP group than in the other groups (P<0.05). The CI group contained significantly more gutta-percha and sealer remnant than the other groups (P<0.05). The apical third of the CI group had significantly more residual gutta-percha and sealer when compared to that of the other groups (P<0.05). Conclusion Within the limitations of this study, the amount of gutta-percha and sealer in the XP group was lower than that in the EA, IS, and CI groups.",2016,The CI group contained significantly more gutta-percha and sealer remnant than the other groups (P<0.05).,['One hundred mandibular canine teeth with flat oval cross-sectioned canals'],"['Conventional needle irrigation (CI', 'XP-endo Finisher (XP), EndoActivator (EA) and IrrıSafe (IS']","['residual gutta-percha and sealer', 'gutta-percha and sealer remnant']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}]",100.0,0.0231621,The CI group contained significantly more gutta-percha and sealer remnant than the other groups (P<0.05).,"[{'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Özyürek', 'Affiliation': 'Department of Endodontics, Ondokuz Mayis University, Faculty of Dentistry, Samsun, Turkey.'}, {'ForeName': 'Ebru Özsezer', 'Initials': 'EÖ', 'LastName': 'Demiryürek', 'Affiliation': 'Department of Endodontics, Ondokuz Mayis University, Faculty of Dentistry, Samsun, Turkey.'}]",European endodontic journal,['10.5152/eej.2016.16002'] 1978,32566902,"The Effect of Preoperative Administration of Antihistamine, Analgesic and Placebo on Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Controlled Trial.","Objective To compare the effect of preoperative administration of an antihistamine, an analgesic, or a placebo on postoperative pain in maxillary molar teeth with symptomatic apical periodontitis.Design: A randomized, controlled trial. Methods Population: A total of 51 patients with moderate-to-severe maxillary molar tooth pain who have undergone a root canal treatment.Intervention: Preoperative administration of either an antihistamine or an analgesic.Control: Versus placeboOutcomes: Reduction in postoperative pain? The data were analyzed with chi-square, one-way analysis of variance (ANOVA) and least significant difference (LSD) post-hoc tests. Results At days 1 and 3, preoperative administration of the antihistamine and analgesic resulted in lower pain levels than the placebo. At days 5 and 7, however, while preoperative administration of the antihistamine still resulted in less pain than the placebo, there was no significant difference between the analgesic and placebo (P>0.05). Conclusion Within the limitations of the present study, the preoperative administration of an antihistamine can be beneficial in reducing the postoperative pain of endodontic treatments.",2016,"At days 1 and 3, preoperative administration of the antihistamine and analgesic resulted in lower pain levels than the placebo.","['maxillary molar teeth with symptomatic apical periodontitis', '51 patients with moderate-to-severe maxillary molar tooth pain who have undergone a root canal treatment', 'Teeth with Symptomatic Apical Periodontitis', 'Methods\n\n\nPopulation']","['antihistamine', 'Antihistamine, Analgesic and Placebo', 'Control', 'Intervention', 'placebo']","['Postoperative Pain', 'postoperative pain', 'lower pain levels', 'pain']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",51.0,0.541257,"At days 1 and 3, preoperative administration of the antihistamine and analgesic resulted in lower pain levels than the placebo.","[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Arslan', 'Affiliation': 'Department of Endodontics, Erzurum Atatürk University School of Dentistry, Erzurum, Turkey.'}, {'ForeName': 'Eyüp Candaş', 'Initials': 'EC', 'LastName': 'Gündoğdu', 'Affiliation': 'Department of Endodontics, Erzurum Atatürk University School of Dentistry, Erzurum, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Sümbüllü', 'Affiliation': 'Department of Endodontics, Erzurum Atatürk University School of Dentistry, Erzurum, Turkey.'}]",European endodontic journal,['10.5152/eej.2016.16012'] 1979,32566904,Caffeine as a Tool to Explore Active Cognitive Processing Stages in Two-Choice Tasks.,"Background: We used caffeine as a tool to explore the active cognitive-processing stages in a simple Go/NoGo task, in terms of the event-related potential (ERP) components elicited by the Go and NoGo stimuli. Methods: Two hundred and fifty milligrams of caffeine was administered to adult participants ( N  = 24) in a randomized double-blind placebo-controlled repeated-measures crossover study. Two blocks of an equiprobable auditory Go/NoGo task were completed, each with a random mix of 75 tones at 1000 Hz and 75 at 1500 Hz, all 60 dB sound pressure level (SPL). Results: Major ERP effects of caffeine were apparent in enhancements of the Go N1-1, P3b, and Slow Wave (SW), and the NoGo Processing Negativity, SW, and NoGo Late Positivity. Conclusions: Novel differential findings indicate the potential of our caffeine as a tool approach to elucidate the functional nature of ERP markers of active cognitive processing in a range of developmental and clinical populations.",2020,"Major ERP effects of caffeine were apparent in enhancements of the Go N1-1, P3b, and Slow Wave (SW), and the NoGo Processing Negativity, SW, and NoGo Late Positivity. ",[],"['caffeine', 'Caffeine', 'placebo']","['enhancements of the Go N1-1, P3b, and Slow Wave (SW), and the NoGo Processing Negativity, SW, and NoGo Late Positivity']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",,0.147122,"Major ERP effects of caffeine were apparent in enhancements of the Go N1-1, P3b, and Slow Wave (SW), and the NoGo Processing Negativity, SW, and NoGo Late Positivity. ","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Barry', 'Affiliation': 'Brain & Behaviour Research Institute, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Jack S', 'Initials': 'JS', 'LastName': 'Fogarty', 'Affiliation': 'Brain & Behaviour Research Institute, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'De Blasio', 'Affiliation': 'Brain & Behaviour Research Institute, University of Wollongong, Wollongong, Australia.'}]",Journal of caffeine and adenosine research,['10.1089/caff.2019.0021'] 1980,32566949,A comparison of effectiveness and cosmetic outcome of two methods for ingrown toenail: partial nail matricectomy using CO2 laser versus lateral nail fold excision.,"BACKGROUND Ingrown toenail (IGT) is a common nail disorder that causes discomfort and interferes with most activities. Most cases of IGT require procedural intervention. This study was performed to compare the treatment and cosmetic outcome of partial nail matricectomy (PNM) using CO2 laser versus lateral nail fold excision (LNFE). METHOD This interventional study was performed on 127 patients with IGT that were randomized into two groups. Demographic data, clinical characteristics, and treatment results were recorded in both groups. RESULTS Sixty-two patients with a mean age of 28.23 ± 11.34 years were subjected to PNM and 65 patients with a mean age of 28.92 ± 9.63 years to LNFE. The PNM versus LNFE groups had cure rates of 85.5% versus 78.5%, fair cosmetic outcomes of 67.9% versus 84.0%, and infection rates of 4.8% versus 3.1%. The mean time of pain duration, return to daily activity, and return to work were nearly 3, 4, and 13 days, respectively, in both groups. CONCLUSION The treatment outcome was slightly better in the PNM group than in the LNFE group, and vice-versa for the cosmetic outcome. There were nearly similar outcomes in terms of the mean time of repair, pain duration, return to daily activity, and infection rate using both methods.",2020,"The PNM versus LNFE groups had cure rates of 85.5% versus 78.5%, fair cosmetic outcomes of 67.9% versus 84.0%, and infection rates of 4.8% versus 3.1%.","['127 patients with IGT', 'Sixty-two patients with a mean age of 28.23 ± 11.34 years were subjected to PNM and 65 patients with a mean age of 28.92 ± 9.63 years to LNFE']","['LNFE', 'partial nail matricectomy (PNM) using CO2 laser versus lateral nail fold excision (LNFE', 'PNM', 'CO2 laser versus lateral nail fold excision']","['mean time of pain duration, return to daily activity, and return to work', 'fair cosmetic outcomes', 'mean time of repair, pain duration, return to daily activity, and infection rate', 'infection rates', 'cure rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027343', 'cui_str': 'Ingrowing nail'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C3544077', 'cui_str': 'Matrixectomy'}, {'cui': 'C0222000', 'cui_str': 'Structure of lateral nail fold'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0222000', 'cui_str': 'Structure of lateral nail fold'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C3544077', 'cui_str': 'Matrixectomy'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",127.0,0.0322588,"The PNM versus LNFE groups had cure rates of 85.5% versus 78.5%, fair cosmetic outcomes of 67.9% versus 84.0%, and infection rates of 4.8% versus 3.1%.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kavoussi', 'Affiliation': 'Hajdaie Dermatology Clinic, School of Medicine, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Hajdaie Dermatology Clinic, School of Medicine, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Health School, Family Health Research Center of Kermanshah University of Medical Sciences (KUMS), Kermanshah, Iran.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Salimi', 'Affiliation': 'Hajdaie Dermatology Clinic, School of Medicine, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Iran.'}, {'ForeName': 'Harif', 'Initials': 'H', 'LastName': 'Rashidian', 'Affiliation': 'School of Medicine, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kavoussi', 'Affiliation': 'School of Medicine, Student Research Committee, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Iran.'}]","Acta dermatovenerologica Alpina, Pannonica, et Adriatica",[] 1981,32557868,"A Randomized, Controlled Trial of Exercise for Parkinsonian Individuals With Freezing of Gait.","BACKGROUND Exercises with motor complexity induce neuroplasticity in individuals with Parkinson's disease (PD), but its effects on freezing of gait are unknown. The objective of this study was to verify if adapted resistance training with instability - exercises with motor complexity will be more effective than traditional motor rehabilitation - exercises without motor complexity in improving freezing-of-gait severity, outcomes linked to freezing of gait, and brain function. METHODS Freezers were randomized either to the adapted resistance training with instability group (n = 17) or to the active control group (traditional motor rehabilitation, n = 15). Both training groups performed exercises 3 times a week for 12 weeks. The primary outcome was the New Freezing of Gait Questionnaire. Secondary outcomes were freezing of gait ratio (turning task), cognitive inhibition (Stroop-III test), motor signs (Unified Parkinson's Disease Rating Scale part-III [UPDRS-III]), quality of life (PD Questionnaire 39), anticipatory postural adjustment (leg-lifting task) and brain activation during a functional magnetic resonance imaging protocol of simulated anticipatory postural adjustment task. Outcomes were evaluated before and after interventions. RESULTS Only adapted resistance training with instability improved all the outcomes (P < 0.05). Adapted resistance training with instability was more effective than traditional motor rehabilitation (in improving freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation; P < 0.05). Our results are clinically relevant because improvement in the New Freezing of Gait Questionnaire (-4.4 points) and UPDRS-III (-7.4 points) scores exceeded the minimally detectable change (traditional motor rehabilitation group data) and the moderate clinically important difference suggested for PD, respectively. The changes in mesencephalic locomotor region activation and in anticipatory postural adjustment amplitude explained the changes in New Freezing of Gait Questionnaire scores and in freezing-of-gait ratio following adapted resistance training with instability, respectively. CONCLUSIONS Adapted resistance training with instability is able to cause significant clinical improvement and brain plasticity in freezers. © 2020 International Parkinson and Movement Disorder Society.",2020,"Adapted resistance training with instability was more effective than traditional motor rehabilitation (in improving freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation; P < 0.05).","['Parkinsonian Individuals With Freezing of Gait', ""individuals with Parkinson's disease (PD"", 'Freezers']",['adapted resistance training with instability group (n = 17) or to the active control group (traditional motor rehabilitation'],"['simulated anticipatory postural adjustment task', 'Gait Questionnaire scores', ""freezing of gait ratio (turning task), cognitive inhibition (Stroop-III test), motor signs (Unified Parkinson's Disease Rating Scale part-III [UPDRS-III]), quality of life (PD Questionnaire 39), anticipatory postural adjustment (leg-lifting task) and brain activation"", 'New Freezing of Gait Questionnaire', 'freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175738', 'cui_str': 'Freezer'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205314', 'cui_str': 'New'}]",,0.0269952,"Adapted resistance training with instability was more effective than traditional motor rehabilitation (in improving freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation; P < 0.05).","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Silva-Batista', 'Affiliation': 'Laboratory of Strength Training, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Andrea Cristina', 'Initials': 'AC', 'LastName': 'de Lima-Pardini', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Mariana Penteado', 'Initials': 'MP', 'LastName': 'Nucci', 'Affiliation': 'Department of Radiology, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel Boari', 'Initials': 'DB', 'LastName': 'Coelho', 'Affiliation': 'Biomedical Engineering, Federal University of ABC, São Bernardo do Campo, SP, Brazil.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Batista', 'Affiliation': 'Department of Radiology, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Elisa Pimentel', 'Initials': 'MEP', 'LastName': 'Piemonte', 'Affiliation': 'Faculty of Medical Science, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Egberto Reis', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, School of Medicine of the University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Luis Augusto', 'Initials': 'LA', 'LastName': 'Teixeira', 'Affiliation': 'Human Motor Systems Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Corcos', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Department of Radiology, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'Laboratory of Strength Training, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28128'] 1982,32558913,Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial.,"Importance Pneumonia affects more than 250 000 nursing home (NH) residents annually. A strategy to reduce pneumonia is to provide daily mouth care, especially to residents with dementia. Objective To evaluate the effectiveness of Mouth Care Without a Battle, a program that increases staff knowledge and attitudes regarding oral hygiene, changes mouth care, and improves oral hygiene, in reducing the incidence of pneumonia among NH residents. Design, Setting, and Participants This pragmatic cluster randomized trial observing 2152 NH residents for up to 2 years was conducted from September 2014 to May 2017. Data collectors were masked to study group. The study included 14 NHs from regions of North Carolina that evidenced proportionately high rehospitalization rates for pneumonia and long-term care residents. Nursing homes were pair matched and randomly assigned to intervention or control groups. Intervention Mouth Care Without a Battle is a standardized program that teaches that mouth care is health care, provides instruction on individualized techniques and products for mouth care, and trains caregivers to provide care to residents who are resistant and in special situations. The control condition was standard mouth care. Main Outcomes and Measures Pneumonia incidence (primary) and hospitalization and mortality (secondary), obtained from medical records. Results Overall, the study enrolled 2152 residents (mean [SD] age, 79.4 [12.4] years; 1281 [66.2%] women; 1180 [62.2%] white residents). Participants included 1219 residents (56.6%) in 7 intervention NHs and 933 residents (43.4%) in 7 control NHs. During the 2-year study period, the incidence rate of pneumonia per 1000 resident-days was 0.67 and 0.72 in the intervention and control NHs, respectively. Neither the primary (unadjusted) nor secondary (covariate-adjusted) analyses found a significant reduction in pneumonia due to Mouth Care Without a Battle during 2 years (unadjusted incidence rate ratio, 0.90; upper bound of 1-sided 95% CI, 1.24; P = .27; adjusted incidence rate ratio, 0.92; upper bound of 1-sided 95% CI, 1.27; P = .30). In the second year, the rate of pneumonia was nonsignificantly higher in intervention NHs. Adjusted post hoc analyses limited to the first year found a significant reduction in pneumonia incidence in intervention NHs (IRR, 0.69; upper bound of 1-sided 95% CI, 0.94; P = .03). Conclusions and Relevance This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year. The lack of significant results in the second year may be associated with sustainability. Improving mouth care in US NHs may require the presence and support of dedicated oral care aides. Trial Registration ClinicalTrials.gov Identifier: NCT03817450.",2020,"This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year.","['14 NHs from regions of North Carolina that evidenced proportionately high rehospitalization rates for pneumonia and long-term care residents', 'residents with dementia', '2152 NH residents for up to 2 years was conducted from September 2014 to May 2017', 'Nursing homes', '250\u202f000 nursing home (NH) residents annually', 'Participants included 1219 residents (56.6%) in 7 intervention NHs and 933 residents (43.4%) in 7 control NHs', 'study enrolled 2152 residents (mean [SD] age, 79.4 [12.4] years; 1281 [66.2%] women; 1180 [62.2%] white residents']","['mouth care program', 'Intervention\n\n\nMouth Care', 'Mouth Care Program Provided by Nursing Home Staff vs Standard Care']","['Pneumonia Incidence', 'pneumonia due to Mouth Care', 'Measures\n\n\nPneumonia incidence (primary) and hospitalization and mortality (secondary), obtained from medical records', 'incidence rate of pneumonia', 'pneumonia incidence', 'rate of pneumonia']","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191368', 'cui_str': '933'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}]",2152.0,0.082596,"This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year.","[{'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sally C', 'Initials': 'SC', 'LastName': 'Stearns', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Poole', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Preisser', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4321'] 1983,32552782,The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study.,"BACKGROUND There is increasing evidence for the use of lower insufflation pressures during laparoscopic surgery. Deep neuromuscular blockade allows for a safe reduction in intra-abdominal pressure without compromising the quality of the surgical field. While there is considerable evidence to support superior surgical conditions during deep neuromuscular blockade, there is only a limited amount of studies investigating patient outcomes. Moreover, results are not always consistent between studies and vary between different types of laparoscopic surgery. This study will investigate the effect of low-pressure pneumoperitoneum facilitated by deep NMB on quality of recovery after laparoscopic colorectal surgery. METHODS The RECOVER study is a multicenter double-blinded randomized controlled trial consisting of 204 patients who will be randomized in a 1:1 fashion to group A, low-pressure pneumoperitoneum (8 mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1-2), or group B, normal-pressure pneumoperitoneum (12 mmHg) with moderate neuromuscular blockade (train-of-four response of 1-2). The primary outcome is quality of recovery on postoperative day 1, quantified by the Quality of Recovery-40 questionnaire. DISCUSSION Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures. This study will identify whether low pressure pneumoperitoneum and deep neuromuscular blockade will enhance recovery after colorectal laparoscopic surgery and, moreover, if this could be a valuable addition to the Enhanced Recovery After Surgery guidelines. TRIAL REGISTRATION EudraCT 2018-001485-42. Registered on April 9, 2018. Clinicaltrials.govNCT03608436. Registered on July 30, 2018.",2020,Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures.,['204 patients who will be randomized in a 1:1 fashion to group A'],"['low- versus normal-pressure pneumoperitoneum', 'laparoscopic colorectal surgery', 'low-pressure pneumoperitoneum (8\u2009mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1-2), or group B, normal-pressure pneumoperitoneum (12\u2009mmHg) with moderate neuromuscular blockade (train-of-four response of 1-2', 'low-pressure pneumoperitoneum facilitated by deep NMB']","['quality of recovery on postoperative day 1, quantified by the Quality of Recovery-40 questionnaire', 'quality of recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0428701', 'cui_str': 'Post-tetanic count'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0068601', 'cui_str': 'neuromedin B'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.554078,Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures.,"[{'ForeName': 'Kim I', 'Initials': 'KI', 'LastName': 'Albers', 'Affiliation': 'Department of Surgery and Anesthesiology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands. Kim.Albers@radboudumc.nl.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Polat', 'Affiliation': 'Department of Surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Ivo F', 'Initials': 'IF', 'LastName': 'Panhuizen', 'Affiliation': 'Department of Anesthesiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc M J', 'Initials': 'MMJ', 'LastName': 'Snoeck', 'Affiliation': 'Department of Anesthesiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Scheffer', 'Affiliation': 'Department of Anesthesiology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans D', 'Initials': 'HD', 'LastName': 'de Boer', 'Affiliation': 'Department of Anesthesiology, Martini General Hospital, Van Swietenplein 1, 9728 NT, Groningen, The Netherlands.'}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Warlé', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}]",Trials,['10.1186/s13063-020-04496-8'] 1984,32552784,Exploring characteristics of COPD patients with clinical improvement after integrated disease management or usual care: post-hoc analysis of the RECODE study.,"BACKGROUND The cluster randomized controlled trial on (cost-)effectiveness of integrated chronic obstructive pulmonary disease (COPD) management in primary care (RECODE) showed that integrated disease management (IDM) in primary care had no effect on quality of life (QOL) in COPD patients compared with usual care (guideline-supported non-programmatic care). It is possible that only a subset of COPD patients in primary care benefit from IDM. We therefore examined which patients benefit from IDM, and whether patient characteristics predict clinical improvement over time. METHOD Post-hoc analyses of the RECODE trial among 1086 COPD patients. Logistic regression analyses were performed with baseline characteristics as predictors to examine determinants of improvement in QOL, defined as a minimal decline in Clinical COPD Questionnaire (CCQ) of 0.4 points after 12 and 24 months of IDM. We also performed moderation analyses to examine whether predictors of clinical improvement differed between IDM and usual care. RESULTS Regardless of treatment type, more severe dyspnea (MRC) was the most important predictor of clinically improved QOL at 12 and 24 months, suggesting that these patients have most room for improvement. Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months). CONCLUSIONS More severe dyspnea is a key predictor of improved QOL in COPD patients over time. More research is needed to replicate patient characteristics associated with clinical improvement with IDM, such that IDM programs can be offered to patients that benefit the most, and can potentially be adjusted to meet the needs of other patient groups as well. TRIAL REGISTRATION Netherlands Trial Register, NTR2268. Registered 31 March 2010.",2020,"Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months). ","['COPD patients with clinical improvement after integrated disease management or usual care', '1086 COPD patients']",[],"['quality of life (QOL', 'QOL', 'Clinical COPD Questionnaire (CCQ', 'severe dyspnea (MRC']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2919593', 'cui_str': 'Clinical chronic obstructive pulmonary disease questionnaire'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",1086.0,0.0920091,"Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months). ","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Meijer', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands. E.Meijer@lumc.nl.'}, {'ForeName': 'Annelies E', 'Initials': 'AE', 'LastName': 'van Eeden', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}, {'ForeName': 'Annemarije L', 'Initials': 'AL', 'LastName': 'Kruis', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}, {'ForeName': 'Melinde R S', 'Initials': 'MRS', 'LastName': 'Boland', 'Affiliation': 'Institute of Health, Policy & Management, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, Netherlands.'}, {'ForeName': 'Willem J J', 'Initials': 'WJJ', 'LastName': 'Assendelft', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, 6500 HB, Nijmegen, Netherlands.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Tsiachristas', 'Affiliation': 'Institute of Health, Policy & Management, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, Netherlands.'}, {'ForeName': 'Maureen P M H', 'Initials': 'MPMH', 'LastName': 'Rutten-van Mölken', 'Affiliation': 'Institute of Health, Policy & Management, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, Netherlands.'}, {'ForeName': 'Marise J', 'Initials': 'MJ', 'LastName': 'Kasteleyn', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01213-8'] 1985,32552805,"Comparing video-based versions of Halsted's 'see one, do one' and Peyton's '4-step approach' for teaching surgical skills: a randomized controlled trial.","BACKGROUND Teaching complex motor skills at a high level remains a challenge in medical education. Established methods often involve large amounts of teaching time and material. The implementation of standardized videos in those methods might help save resources. In this study, video-based versions of Peyton's '4-step Approach' and Halsted's 'See One, Do One' are compared. We hypothesized that the video-based '4-step Approach' would be more effective in learning procedural skills than the 'See One, Do One Approach'. METHODS One-hundred-two naïve students were trained to perform a structured facial examination and a Bellocq's tamponade with either Halsted's (n = 57) or Peyton's (n = 45) method within a curricular course. Steps 1 (Halsted) and 1-3 (Peyton) were replaced by standardized teaching videos. The performance was measured directly (T1) and 8 weeks (T2) after the intervention by blinded examiners using structured checklists. An item-analysis was also carried out. RESULTS At T1, performance scores significantly differed in favor of the video-based '4-step Approach' (p < 0.01) for both skills. No differences were found at T2 (p < 0.362). The item-analysis revealed that Peyton's method was significantly more effective in the complex subparts of both skills. CONCLUSIONS The modified video-based version of Peyton's '4-step Approach' is the preferred method for teaching especially complex motor skills in a large curricular scale. Furthermore, an effective way to utilize Peyton's method in a group setting could be demonstrated. Further studies have to investigate the long-term learning retention of this method in a formative setting.",2020,"At T1, performance scores significantly differed in favor of the video-based '4-step Approach' (p < 0.01) for both skills.",['One-hundred-two naïve'],"[""structured facial examination and a Bellocq's tamponade with either Halsted's (n\u2009=\u200957) or Peyton's""]",[],"[{'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]",[],102.0,0.0690792,"At T1, performance scores significantly differed in favor of the video-based '4-step Approach' (p < 0.01) for both skills.","[{'ForeName': 'Lukas B', 'Initials': 'LB', 'LastName': 'Seifert', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany. lukasbenedikt.seifert@kgu.de.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schnurr', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Maria-Christina', 'Initials': 'MC', 'LastName': 'Stefanescu', 'Affiliation': 'Department of Pediatric Surgery and Pediatric Urology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sader', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ruesseler', 'Affiliation': 'Department of Trauma, Reconstructive and Hand Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Sterz', 'Affiliation': 'Department of Trauma, Reconstructive and Hand Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}]",BMC medical education,['10.1186/s12909-020-02105-5'] 1986,32552828,Conversion of I-gel to definitive airway in a cervical immobilized manikin: Aintree intubation catheter vs long endotracheal tube.,"BACKGROUND After prehospital insertion of i-gel, a popular supraglottic airway (SGA), fiberoptic-guided intubation through i-gel is often required to switch the i-gel to a definitive airway for anticipated difficult airway. The Aintree intubation catheter (AIC) was developed for this purpose yet it requires many procedural steps during which maintenance of adequate ventilation is difficult. We custom-made a long endotracheal tube (LET) which may facilitate this procedure and compared the efficacy of the AIC and LET in a cervical immobilized manikin. METHODS In this 2 × 2 crossover manikin-based trial, 20 anaesthesiologists and residents performed both methods in random order. Total intubation time, fiberoptic time, and procedure time were recorded. The ease of insertion, procedure failure rate, difficulty score, and participants' preference were recorded. RESULTS Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001). The procedure time was significantly shorter in the LET group (51.9 ± 13.8 s vs 76.5 ± 25.4 s, P <  0.001). The ease of insertion score was lower, i.e., easier, in the AIC than the LET group (2.0 [1.0-2.75] vs 1.0 [1.0-1.0], P <  0.001). Fiberoptic time (19.0 ± 6.9 s vs 17.5 ± 12.3 s) and subjective difficulty (4.0 [3.0-6.0] vs 4.0 [3.0-5.75]) were similar between groups. Fourteen participants preferred the LET method (70%) due to its fewer procedural steps. CONCLUSIONS LET resulted in a shorter intubation time than the AIC during fiberoptic-guided intubation through the i-gel, possibly due to the less procedural steps compared to AIC. TRIAL REGISTRATION NCT03645174 (ClinicalTrials.gov, Aug 22, 2018).",2020,"RESULTS Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001).",[],"['custom-made a long endotracheal tube (LET', 'LET', 'Aintree intubation catheter (AIC']","['Fiberoptic time', 'procedure time', 'subjective difficulty', 'Total intubation time', 'shorter intubation time', 'ease of insertion score', 'Total intubation time, fiberoptic time, and procedure time']",[],"[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.129802,"RESULTS Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001).","[{'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Chae', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'Heirim', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Office of Biostatics, Ajou Research Institute for Innovative Medicine, Ajou University Medical Center, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'Bokyeong', 'Initials': 'B', 'LastName': 'Jun', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'In Kyong', 'Initials': 'IK', 'LastName': 'Yi', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea. lyrin01@gmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01069-9'] 1987,32552839,Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).,"BACKGROUND The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest. METHODS/DESIGN The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial. DISCUSSION The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking. TRIAL REGISTRATION ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.",2020,"The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care).",[],"['bedside evidence-based checklist', 'intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care']","['number of actual organ donors and the number of solid organs recovered per actual donor', 'achievement of relevant clinical goals during the management of brain-dead potential organ donors', 'loss of potential donors due to cardiac arrest']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}, {'cui': 'C0440790', 'cui_str': 'Solid organ'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]",,0.111504,"The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care).","[{'ForeName': 'Natalia Elis', 'Initials': 'NE', 'LastName': 'Giordani', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil. natigiordani@gmail.com.'}, {'ForeName': 'Caroline Cabral', 'Initials': 'CC', 'LastName': 'Robinson', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Glauco Adrieno', 'Initials': 'GA', 'LastName': 'Westphal', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Adult Intensive Care Unit, HMV, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sganzerla', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Hospital do Coração (HCor), São Paulo, SP, Brazil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Department of Anaesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, SP, Brazil.'}, {'ForeName': 'Fernando Augusto', 'Initials': 'FA', 'LastName': 'Bozza', 'Affiliation': ""Department of Critical Care and Postgraduate Programme in Translational Medicine, D'Or Institute for Research and Education, Rio de Janeiro, RJ, Brazil.""}, {'ForeName': 'Cassiano', 'Initials': 'C', 'LastName': 'Teixeira', 'Affiliation': 'Department of Internal Medicine and Postgraduate Programme in Rehabilitation Science, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'de Andrade', 'Affiliation': 'Organ Procurement Organisation of Santa Catarina (OPO/SC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Cristiano Augusto', 'Initials': 'CA', 'LastName': 'Franke', 'Affiliation': 'Adult Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cátia Moreira', 'Initials': 'CM', 'LastName': 'Guterres', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Itiana Cardoso', 'Initials': 'IC', 'LastName': 'Madalena', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Adriane Isabel', 'Initials': 'AI', 'LastName': 'Rohden', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Sabrina Souza', 'Initials': 'SS', 'LastName': 'da Silva', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Luiza Vitelo', 'Initials': 'LV', 'LastName': 'Andrighetto', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Gabriela Soares', 'Initials': 'GS', 'LastName': 'Rech', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Bruna Dos Passos', 'Initials': 'BDP', 'LastName': 'Gimenes', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Luciano Serpa', 'Initials': 'LS', 'LastName': 'Hammes', 'Affiliation': 'Office of the Superintendent, HMV, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Daniela Ferreira Salomão', 'Initials': 'DFS', 'LastName': 'Pontes', 'Affiliation': 'General Coordination Office of the National Transplant System, Ministério da Saúde, Brasília, DF, Brazil.'}, {'ForeName': 'Maureen O', 'Initials': 'MO', 'LastName': 'Meade', 'Affiliation': 'Department of Medicine and Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Maicon', 'Initials': 'M', 'LastName': 'Falavigna', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}]",Trials,['10.1186/s13063-020-04457-1'] 1988,32553417,Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial.,"INTRODUCTION Cleaning and shaping are necessary to allow for the delivery of irrigants and medicaments to the apical third of the canal. Standard treatment irrigation generally uses a conventional needle and some frequency of sonic activation. The GentleWave System (GWS; Sonendo, Inc, Laguna Hills, CA) combines irrigant delivery with multisonic activation. This randomized clinical trial aimed to determine if the GWS significantly decreases the incidence and intensity of postoperative pain. METHODS Patients used a numeric rating scale to record their pain level at the 6-hour time point before treatment. All participants were randomly divided into 2 groups and were blind to the treatment they received. The standard (control) group received endodontic treatment with conventional side-vented needle irrigation and ultrasonic activation. The second group received treatment with the GWS. Following treatment, patients used a numeric rating scale to record their pain level at 6, 24, 72, and 168 hours. RESULTS In the standard treatment group, 72.2% of patients experienced at least 1 occurrence of postoperative pain, whereas in the GWS group, 83.3% of patients experienced at least 1 occurrence of postoperative pain. The highest pain intensity level for both treatments occurred at the 6-hour posttreatment time point. All pain decreased with time after the 6-hour posttreatment time point (P < 1.237e -7 ). CONCLUSIONS There was no significant difference in the incidence or intensity of postoperative pain after either treatment group. However, both groups reported a statistically significant decrease in pain with time.",2020,"All pain decreased with time after the 6-hour posttreatment time point (P < 1.237e -7 ). ",[],"['GWS', 'GentleWave System', 'endodontic treatment with conventional side-vented needle irrigation and ultrasonic activation']","['All pain', 'postoperative pain', 'pain with time', 'highest pain intensity level', 'Postoperative Pain', 'incidence or intensity of postoperative pain', 'numeric rating scale to record their pain level']",[],"[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0181988', 'cui_str': 'Medication transfer needle, vented'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.0471475,"All pain decreased with time after the 6-hour posttreatment time point (P < 1.237e -7 ). ","[{'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Grigsby', 'Affiliation': 'Division of Endodontics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota. Electronic address: grigs029@umn.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ordinola-Zapata', 'Affiliation': 'Division of Endodontics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'McClanahan', 'Affiliation': 'Division of Endodontics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Fok', 'Affiliation': 'Minnesota Dental Research Center for Biomaterials and Biomechanics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota.'}]",Journal of endodontics,['10.1016/j.joen.2020.04.004'] 1989,32556156,Vision-Related Functioning in Patients Undergoing Pneumatic Retinopexy vs Vitrectomy for Primary Rhegmatogenous Retinal Detachment: A Post Hoc Exploratory Analysis of the PIVOT Randomized Clinical Trial.,"Importance Although rhegmatogenous retinal detachment (RRD) repair techniques have high anatomical reattachment rates, there may be differences in various aspects of postoperative vision-related quality of life (VRQoL). Objective To explore the differences in various aspects of VRQoL between pneumatic retinopexy (PnR) and pars plana vitrectomy (PPV) following RRD repair. Design, Setting, and Participants Post hoc exploratory analysis of the the Pneumatic Retinopexy vs Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes randomized clinical trial conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada. Patients with RRD with a single break or multiple breaks within 1 clock hour of detached retina in the superior 8 clock hours of the retina with any number, location, and size of retinal breaks or lattice degeneration in attached retina. Main Outcomes and Measures Differences in the 25-Item National Eye Institute Visual Function Questionnaire 12 subscale scores between the PnR and PPV groups at 6 months following RRD repair. Results A total of 160 patients were included in this analysis, with 81 patients (92%) and 79 patients (90%) in the PnR and PPV groups, respectively. The PnR group consisted of 32% women with a mean (SD) age of 60.9 (9.3) years, while the PPV group consisted of 38% women with a mean (SD) age of 60.3 (7.6) years. For the 152 patients with 6-month follow-up (75 patients in PnR [85%] and 77 patients in PPV [88%]), there was evidence for an association of PnR with superior vision-related functioning compared with PPV for several subscales. There were no differences between groups at 1 year. After adjusting for age, sex, baseline macular status, visual acuity in the nonstudy eye, and lens status, patients who underwent PnR had higher scores for distance activities (mean [SD] PnR, 88.7 [13.4]; PPV, 82.8 [17.1]; adjusted difference, 6.5; 95% CI, 1.6-11.4; P = .01), mental health (mean [SD] PnR, 84.3 [17.4]; PPV, 78.7 [21.1]; adjusted difference, 6.7; 95% CI, 0.4-13; P = .04), dependency (mean [SD] PnR, 96.1 [10.1]; PPV, 91.1 [18.6]; adjusted difference, 5.7; 95% CI, 0.6-10.8; P = .03), and peripheral vision (mean [SD] PnR, 91.6 [16.2]; PPV, 81.2 [24.4]; adjusted difference, 10.8; 95% CI, 4.3-17.4; P = .001) at 6 months. Conclusions and Relevance These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV. Trial Registration ClinicalTrials.gov Identifier: NCT01639209.",2020,"These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV. ","['Primary Rhegmatogenous Retinal Detachment', ""Primary Rhegmatogenous Retinal Detachment Outcomes randomized clinical trial conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada"", 'The PnR group consisted of 32% women with a mean (SD) age of 60.9 (9.3) years, while the PPV group consisted of 38% women with a mean (SD) age of 60.3 (7.6) years', 'Patients with RRD', 'Patients Undergoing', '160 patients were included in this analysis, with 81 patients (92%) and 79 patients (90%) in the PnR and PPV groups, respectively']","['Pneumatic Retinopexy vs Vitrectomy', 'rhegmatogenous retinal detachment (RRD) repair techniques', 'pneumatic retinopexy (PnR) and pars plana vitrectomy (PPV']","['mental health scores and superior vision-related functioning scores', '25-Item National Eye Institute Visual Function Questionnaire 12 subscale scores', '25-Item National Eye Institute Visual Function Questionnaire', 'peripheral vision', 'mental health', 'distance activities']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0234628', 'cui_str': 'Peripheral vision'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",160.0,0.412786,"These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV. ","[{'ForeName': 'Rajeev H', 'Initials': 'RH', 'LastName': 'Muni', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carolina L M', 'Initials': 'CLM', 'LastName': 'Francisconi', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Felfeli', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael Y K', 'Initials': 'MYK', 'LastName': 'Mak', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Berger', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Wong', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Filiberto', 'Initials': 'F', 'LastName': 'Altomare', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Louis R', 'Initials': 'LR', 'LastName': 'Giavedoni', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Radha P', 'Initials': 'RP', 'LastName': 'Kohly', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kertes', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Figueiredo', 'Affiliation': ""St Michael's Hospital, Department of Ophthalmology, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Roxane J', 'Initials': 'RJ', 'LastName': 'Hillier', 'Affiliation': 'Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne, England.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2007'] 1990,32345594,Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak.,"The novel COVID-19 outbreak has affected more than 200 countries and territories as of March 2020. Given that patients with cancer are generally more vulnerable to infections, systematic analysis of diverse cohorts of patients with cancer affected by COVID-19 is needed. We performed a multicenter study including 105 patients with cancer and 536 age-matched noncancer patients confirmed with COVID-19. Our results showed COVID-19 patients with cancer had higher risks in all severe outcomes. Patients with hematologic cancer, lung cancer, or with metastatic cancer (stage IV) had the highest frequency of severe events. Patients with nonmetastatic cancer experienced similar frequencies of severe conditions to those observed in patients without cancer. Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer. These findings indicate that patients with cancer appear more vulnerable to SARS-CoV-2 outbreak. SIGNIFICANCE: Because this is the first large cohort study on this topic, our report will provide much-needed information that will benefit patients with cancer globally. As such, we believe it is extremely important that our study be disseminated widely to alert clinicians and patients. This article is highlighted in the In This Issue feature, p. 747 .",2020,"Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer.","['patients with cancer', 'Patients with nonmetastatic cancer', '105 patients with cancer and 536 age-matched noncancer patients confirmed with COVID-19', 'patients with cancer globally', 'Patients with Cancer Appear More Vulnerable to SARS-CoV-2', 'Patients with hematologic cancer, lung cancer, or with metastatic cancer (stage IV']",['radiotherapy'],"['severe events', 'higher risks of having severe events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",105.0,0.0266972,"Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer.","[{'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Dai', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Dianbo', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.""}, {'ForeName': 'Fuxiang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, China.'}, {'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhian', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecology, The Central Hospital of Huanggang, Huanggang, Hubei, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qichao', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Department of Ultrasound, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': 'Cancer Center, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Hubei Cancer Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': 'Department of Thoracic Surgery, Hubei Cancer Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Siping', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': 'Department of Oncology, Wuhan Puren Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhen', 'Affiliation': 'Department of Obstetrics and Gynecology, The Central Hospital of Xianning, Xianning, Hubei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Central Hospital of Xiaogan, Xiaogan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, The People's Hospital of Huangmei, Huangmei, Hubei, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, Xiangyang First People's Hospital affiliated to Hubei University of Medicine, Xiangyang, Hubei, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, China.'}, {'ForeName': 'Yeshan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Department of Gynecology, The Central Hospital of Huanggang, Huanggang, Hubei, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Oncology, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhuyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, The People's Hospital of Shiyan, Shiyan, Hubei, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuwen', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Tenen', 'Affiliation': 'Harvard Stem Cell Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chai', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lorelei A', 'Initials': 'LA', 'LastName': 'Mucci', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Dana-Farber, Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Santillana', 'Affiliation': ""Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.""}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.'}]",Cancer discovery,['10.1158/2159-8290.CD-20-0422'] 1991,32386275,Mass Spectrometry-Based Analysis of Urinary Biomarkers for Dietary Tomato Intake.,"SCOPE In this study, the applicability of several β-carboline, imidazole, and steroidal alkaloids as biomarkers for tomato juice intake is evaluated. METHODS AND RESULTS Over the course of a 2-week crossover dietary intervention study, 14 volunteers were given low and high doses of tomato juice after 3 days of avoiding tomato-based products. On the day of consumption and the following days, volunteers provided urine samples that were quantitatively analyzed by high-performance liquid chromatography-tandem mass spectrometry. Herein, glucose-derived β-carboline alkaloids are determined as supporting, yet non-specific dietary biomarkers for tomato juice intake. Several imidazole alkaloids represent further biomarkers, which are shown to specifically indicate consumption of tomato juice for 24 h and partly >24 h. Additionally, steroidal alkaloids derived from esculeogenin B are determined to be specific biomarkers for tomato juice detectable for at least 48 h after consumption. The intake of low and high amounts of tomato juice is significantly distinguishable based on the urinary excretion of all determined biomarkers as well. CONCLUSIONS The dietary intake of tomato juice is conclusively traceable based on urinary excretion of multiple β-carboline, imidazole, and steroidal alkaloids, and can be determined for up to 48 h after consumption. Furthermore, different intake doses can clearly be distinguished based on their urinary excretion.",2020,"The intake of low and high amounts of tomato juice is significantly distinguishable based on the urinary excretion of all determined biomarkers as well. ",['14 volunteers'],"['β-carboline, imidazole, and steroidal alkaloids']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0007007', 'cui_str': 'Pyrido(4,3-b)Indoles'}, {'cui': 'C0020923', 'cui_str': 'Imidazole'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}]",[],14.0,0.0188236,"The intake of low and high amounts of tomato juice is significantly distinguishable based on the urinary excretion of all determined biomarkers as well. ","[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Hövelmann', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Lewin', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Steinert', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hübner', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Humpf', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000011'] 1992,32554105,Cost-effectiveness of a collaborative care program for managing major depression and chronic musculoskeletal pain in primary care: Economic evaluation alongside a randomized controlled trial.,"BACKGROUND We designed a collaborative care program for the integrated management of chronic musculoskeletal pain and depression, which frequently coexist in primary care patients. The aim of this study was to evaluate the cost-effectiveness of this program compared with care as usual. METHODS We performed a cost-effectiveness analysis alongside a randomized clinical trial. Results were monitored over a 12-month period. The primary outcome was the incremental cost-effectiveness ratio (ICER). We performed cost-effectiveness analyses from the perspectives of the healthcare system and society using an intention-to-treat approach with imputation of missing values. RESULTS We evaluated 328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline. From the healthcare system perspective, the mean incremental cost was €234 (p = .17) and the mean incremental effectiveness was 0.009 QALYs (p = .66), resulting in an ICER of €23,989/QALY. Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY. These estimates were associated with a high degree of uncertainty illustrated on the cost-effectiveness plane. CONCLUSIONS Contrary to our expectations, the collaborative care program had no significant effects on health status, and although the additional costs of implementing the program compared with care as usual were not high, we were unable to demonstrate a favorable cost-effectiveness ratio, largely due to the high degree of uncertainty surrounding the estimates.",2020,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","['328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline', 'primary care patients', 'managing major depression and chronic musculoskeletal pain in primary care']",['collaborative care program'],"['Cost-effectiveness', 'mean incremental effectiveness', 'mean incremental cost', 'health status', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",328.0,0.0923458,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","[{'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Aragonès', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain. Electronic address: earagones.tgn.ics@gencat.cat.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sánchez-Iriso', 'Affiliation': 'Department of Economics, Public University of Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'López-Cortacans', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Tomé-Pires', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; ISCTE-Lisbon University Institute (ISCTE-IUL), Center for Social Research and Intervention (CIS-IUL), Lisbon, Portugal.""}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Rambla', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': ""Unit for the Study and Treatment of Pain - ALGOS, Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110167'] 1993,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients. MATERIALS AND METHODS Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests. RESULTS At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05). CONCLUSION A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003'] 1994,32554135,The relationship between the tympanostomy tube extrusion time and viscosity.,"OBJECTIVE The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid. METHODS Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded. RESULTS The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant. CONCLUSION The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time. TRIAL REGISTRATION NUMBER NCT03848026.",2020,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"['Patients with effusion values below and above the median viscosity value of 439\xa0cP (cP', 'Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study']",[],"['mean tube extrusion time', 'tube extrusion time and the viscosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]",33.0,0.0301946,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Degirmenci', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: ndegirmenci@bezmialem.edu.tr.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Tugrul', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: selahattintugrul@yahoo.com.'}, {'ForeName': 'Seda Sezen', 'Initials': 'SS', 'LastName': 'Goktas', 'Affiliation': '75. Yil Boyabat State Hospital, Department of Otorhinolaryngology and Head and Neck Surgery, Sinop, Turkey. Electronic address: sedasezengoktas@gmail.com.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Senturk', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: erolsent@gmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Calim', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: omercalim@yahoo.com.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Dogan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: dr.remzidogan@hotmail.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yenigun', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: alperyenigun@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ozturan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: orhanent@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110140'] 1995,32554173,Neuroendocrine biomarkers of prolonged exposure treatment response in military-related PTSD.,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone. Preliminary evidence from animal models suggests that baseline levels of these biomarkers may predict response to PTSD treatment. We report the change in biomarkers over the course of PTSD treatment. Biomarkers were sampled from individuals participating in (1) a randomized controlled trial comparing a web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT) and (2) from individuals participating in a nonrandomized effectiveness study testing PE delivered in-person as part of an intensive outpatient PTSD program. We found that higher cortisol reactivity during script-driven imagery was associated with higher baseline PTSD severity and that baseline allopregnanolone, pregnanolone, and cortisol reactivity were associated with degree of symptom change over the course of intensive outpatient treatment. These findings demonstrate that peripherally assessed biomarkers are associated with PTSD severity and likelihood of successful treatment outcome of PE delivered daily over two weeks. These assessments could be used to determine which patients are likely to respond to treatment and which patients require augmentation to increase the likelihood of optimal response to PTSD treatment.",2020,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","['military-related PTSD', 'Posttraumatic stress disorder (PTSD']","['web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT', 'pregnanolone']",['higher cortisol reactivity'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033008', 'cui_str': '3 alpha, 5 beta-Tetrahydroprogesterone'}]","[{'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0279829,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sripada', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA. Electronic address: rekaufma@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: mark.steven.burton@emory.edu.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: vmichop@emory.edu.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kerley', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: kimberly.kerley@emory.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Marx', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: christine.marx@duke.edu.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Kilts', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jason.kilts@duke.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Naylor', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jennifer.naylor@duke.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: brothba@emory.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Rd, Menlo Park, CA, 94025, USA; Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 291 Campus Dr., Stanford, CA, 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Emory University School of Medicine, Department of Obstetrics and Gynecology, 101 Woodruff Circle NE, Ste 4217, Atlanta, 30322, USA. Electronic address: alicia.smith@emory.edu.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: SNorrholm@wayne.edu.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: tjovanovic@med.wayne.edu.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Texas A&M University, 8447 Riverside Parkway, Bryan, TX, 77808-3260, USA. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Col Jeffrey S', 'Initials': 'CJS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Department of Behavioral Health, 36065 Santa Fe Ave., Fort Hood, TX, 76544, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'VA Boston Healthcare System, National Center for PTSD (116B-2), 150 South Huntington Avenue, Boston, MA, 02130, USA; Boston University School of Medicine, Department of Psychiatry, 720 Harrison Avenue, Room 906, Boston, MA, 02118, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA; South Texas Veterans Health Care System, Research and Development Service, 7400 Merton Minter, San Antonio, TX, 78229, USA; University of Texas at San Antonio, Department of Psychology, One UTSA Circle, San Antonio, TX, 78249, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104749'] 1996,32567290,Combination of vitamin A and D supplementation for ischemic stroke: effects on interleukin-1ß and clinical outcome.,"Aim Accumulated evidence suggests that vitamin A and D agonists can alleviate the development of atherosclerosis. Therefore, the aim of this study was to determine the effect of vitamin A and D combination supplement on interleukin-1β (IL-1β) and clinical outcome in ischemic stroke. Methods A single-blind, randomized controlled trial was conducted on ischemic stroke patients at Adam Malik Hospital between March 2018 to February 2019. The patients were randomized into 4 groups of the treatment consisting of supplementation using vitamin A or D only, combination of vitamin A and D, and placebo group, all given for 12 weeks. Clinical outcome was determined using the National Institute of Health Stroke Scale (NIHSS). At the time of admission and after the treatment was completed, all patients were measured for vitamin A, vitamin D, and IL-1β serum level, and NIHSS score. Results From the total of 120 patients, in the combination group there were significant increments on both vitamin A (p=0.04) and vitamin D (p=0.01) serum level after 12 weeks of the treatment, compared to the other groups. In conjunction, IL-1β serum level showed a significant decrement in the combination group (p<0.001). Lastly, the biggest improvement of NIHSS could be seen in the combination group, which was marked by the highest decrement of NIHSS score (p<0.001). Conclusion Administration of combination of vitamin A and D supplementation can significantly increase vitamin A and D serum level, decrease IL-1β serum level, and ultimately improve clinical outcome in ischemic stroke patients.",2020,"in the combination group there were significant increments on both vitamin A (p=0.04) and vitamin D (p=0.01) serum level after 12 weeks of the treatment, compared to the other groups.","['ischemic stroke patients', 'ischemic stroke patients at Adam Malik Hospital between March 2018 to February 2019', 'ischemic stroke', '120 patients']","['vitamin A and D agonists', 'supplementation using vitamin A or D only, combination of vitamin A and D, and placebo', 'vitamin A and D combination supplement', 'vitamin A and D supplementation']","['IL-1β serum level', 'National Institute of Health Stroke Scale (NIHSS', 'NIHSS score', 'vitamin D (p=0.01) serum level', 'vitamin A, vitamin D, and IL-1β serum level, and NIHSS score', 'vitamin A and D serum level, decrease IL-1β serum level']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",120.0,0.31388,"in the combination group there were significant increments on both vitamin A (p=0.04) and vitamin D (p=0.01) serum level after 12 weeks of the treatment, compared to the other groups.","[{'ForeName': 'Alfansuri', 'Initials': 'A', 'LastName': 'Kadri', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Sumatera Utara, Indonesia.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Sjahrir', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Sumatera Utara, Indonesia.'}, {'ForeName': 'Rosita', 'Initials': 'R', 'LastName': 'Juwita Sembiring', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Universitas Sumatera Utara, Indonesia.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ichwan', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Universitas Sumatera Utara, Indonesia.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1137-20'] 1997,32567339,The Effects of Lipid-Lowering Therapy on Serum Eicosapentaenoic Acid to Arachidonic Acid Ratio: An HIJ-PROPER Sub-Analysis.,"BACKGROUND Controversy remains regarding the influence of lipid-lowering therapy on the eicosapentaenoic acid/arachidonic acid ratio. OBJECTIVE This study aimed to clarify the effects of lipid-lowering therapy on the eicosapentaenoic acid/arachidonic acid ratio in patients with acute coronary syndrome (ACS). METHODS This was a post hoc sub-analysis of the Heart Institute of Japan-PRoper level of lipid-lowering with pitavastatin and ezetimibe in ACS study. We compared the eicosapentaenoic acid/arachidonic acid ratio changes from baseline to the 3-month follow-up after contemporary lipid-lowering therapy with pitavastatin + ezetimibe therapy and pitavastatin mono-therapy. RESULTS Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34, P < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27, P = .18). When the analysis was limited to patients who received 2 mg/day of pitavastatin during the follow-up period, these trends in changes of the eicosapentaenoic acid/arachidonic acid ratio remained unchanged. Multivariate analysis showed that ezetimibe use ( P = .005; β = 0.09), ST-elevation myocardial infarction ( P = .04; β = -0.01), and baseline low-density lipoprotein cholesterol (LDL-C) level ( P = .0003; β = 0.12) were independent predictors of the percentage change in the eicosapentaenoic acid/arachidonic acid ratio. These trends were similar even when the analysis was limited to patients who did not take statins at enrollment. CONCLUSION Standard lipid-lowering therapy with pitavastatin mono-therapy improved the eicosapentaenoic acid/arachidonic acid ratio for patients with ACS. Intensive lipid-lowering therapy with pitavastatin + ezetimibe did not improve the eicosapentaenoic acid/arachidonic acid ratio, although LDL-C decreased significantly. Inhibition of the improvement in the eicosapentaenoic acid/arachidonic acid ratio by adding ezetimibe may affect cardiovascular disease prognosis.",2020,"Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34, P < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27, P = .18).","['patients with ACS', 'patients with acute coronary syndrome (ACS']","['pitavastatin', 'eicosapentaenoic acid/arachidonic acid', 'pitavastatin mono-therapy', 'ezetimibe', 'eicosapentaenoic acid/arachidonic acid ratio', 'Lipid-Lowering Therapy', 'lipid-lowering therapy', 'pitavastatin and ezetimibe', 'pitavastatin + ezetimibe therapy and pitavastatin mono-therapy', 'pitavastatin + ezetimibe']","['eicosapentaenoic acid/arachidonic acid', 'baseline low-density lipoprotein cholesterol (LDL-C) level', 'eicosapentaenoic acid/arachidonic acid ratio, although LDL-C', 'eicosapentaenoic acid/arachidonic acid ratio', 'Serum Eicosapentaenoic Acid to Arachidonic Acid Ratio', 'ST-elevation myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]",,0.0782305,"Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34, P < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27, P = .18).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420931621'] 1998,32567340,Concerns of Parental HIV Disclosure in China.,"Although parental HIV disclosure has benefits for parents and children, the disclosure rate among parents remains low. This study aims to qualitatively examine parental concerns regarding disclosure of their HIV status to their children. Eighty parents were enrolled in a randomized controlled trial of a three-session disclosure-support intervention, with forty receiving the intervention and forty receiving treatment as usual. Intervention sessions were audio recorded, and transcriptions were qualitatively coded for content related to concerns of disclosure. Four themes emerged: Intention to disclose, disclosure approach, indicators for disclosure, and fears about disclosure. These themes reveal struggles that parents experience when considering HIV disclosure suggesting that an effective disclosure intervention must help parents assess pros and cons, discuss the emotions of the children after the disclosure, and monitor the impact on children's lives after disclosure over time. Future research is needed to implement interventions supporting HIV-positive parents' disclosure decision-making and actions.",2020,"Eighty parents were enrolled in a randomized controlled trial of a three-session disclosure-support intervention, with forty receiving the intervention and forty receiving treatment as usual.","['Eighty parents', 'Concerns of Parental HIV Disclosure in China']",['three-session disclosure-support intervention'],[],"[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],80.0,0.0580408,"Eighty parents were enrolled in a randomized controlled trial of a three-session disclosure-support intervention, with forty receiving the intervention and forty receiving treatment as usual.","[{'ForeName': 'Meiyan', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Wei-Ti', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yang', 'Affiliation': 'University of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Yale University, Orange, CT, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Bao', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}]",Clinical nursing research,['10.1177/1054773820932725'] 1999,32567356,Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study.,"OBJECTIVE To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors. DESIGN Feasibility randomised controlled study with nested qualitative interview study. SETTING The intervention was delivered in the community in either a group or one-to-one format. SUBJECTS Carers and stroke survivors within one year of stroke onset. INTERVENTIONS A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention. MAIN OUTCOME Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation). RESULTS Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups. CONCLUSIONS Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs.",2020,Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats.,"['Eighteen participants', '257 carers approached, 41 consented', 'stroke carers (BISC', 'carers of stroke survivors', 'Carers and stroke survivors within one year of stroke onset']","['biopsychosocial intervention', 'Biopsychosocial intervention']","['Stroke survivors', 'Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",30.0,0.0489389,Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats.,"[{'ForeName': 'Marion F', 'Initials': 'MF', 'LastName': 'Walker', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Birchall', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cobley', 'Affiliation': 'Department of Clinical Psychology, Derbyshire Healthcare NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Condon', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Fletcher-Smith', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Miriam R', 'Initials': 'MR', 'LastName': 'Golding-Day', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Greensmith', 'Affiliation': 'IAPT Service, Nottinghamshire Healthcare NHS Foundation Trust, UK.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Kontou', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Matias', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Shirley A', 'Initials': 'SA', 'LastName': 'Thomas', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Whitehead', 'Affiliation': 'Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle-Upon-Tyne, UK.'}]",Clinical rehabilitation,['10.1177/0269215520937039'] 2000,32567518,A Clustered Randomized Trial Informing Patients on Dialysis About Their Ability to Donate Organs and Tissues.,"INTRODUCTION The transplant waiting list exceeds the number of organs available. One means of increasing the organ pool is to broaden potential donors to include those with chronic diseases. RESEARCH QUESTIONS The study tested the effectiveness of using peer mentors to encourage individuals on dialysis to enroll on an organ donor registry. DESIGN Dialysis units were pair-matched by size and racial composition and then randomized to one of 2 interventions: meetings with a peer mentor (experimental intervention) or organ donation mailings (control). Peer mentors were trained to discuss organ donation with individuals on dialysis during in-person meetings at dialysis units. The primary outcome was verified registration in the state's donor registry. RESULTS After adjusting for age, gender, race, income, and education and accounting for correlation within the dialysis center, there was a significant intervention effect. Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group. DISCUSSION The use of peer mentors to discuss donating organs after death with individuals on dialysis can increase enrollment on a donor registry. Dispelling myths about chronic illness and donation can counter widely held misconceptions and help persons make an informed choice about end-of-life decisions and present an opportunity to increase the number of organs and tissues available for transplant.",2020,"Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group. ",[],['peer mentor (experimental intervention) or organ donation mailings (control'],"[""verified registration in the state's donor registry""]",[],"[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]",,0.028342,"Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group. ","[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Andrews', 'Affiliation': 'National Kidney Foundation of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Allyce Haney', 'Initials': 'AH', 'LastName': 'Smith', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Loughery', 'Affiliation': 'National Kidney Foundation of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Remonia', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Gift of Life Michigan, Minority Organ and Tissue Transplant Education Program, Ann Arbor, MI, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Jenkins Riley', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Stav', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Yee', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA.'}]","Progress in transplantation (Aliso Viejo, Calif.)",['10.1177/1526924820933840'] 2001,32567522,The effect of rat nerve growth factor combined with vitamin B on peripheral neuropathy in multiple myeloma patients.,"Background: Peripheral neuropathy can induce marked disability and negative effects on quality of life and is the most common therapy-related complication in multiple myeloma patients treated with bortezomib. Currently, there is no useful method to prevent or treat it. So, it is necessary to study the clinical efficacy of rat nerve growth factor combined with vitamin B for the treatment of peripheral neuropathy in multiple myeloma patients. Methods: Sixty multiple myeloma patients who developed peripheral neuropathy after bortezomib-based chemotherapy in Jiaxing First Hospital from October 2015 to May 2018 were randomly divided into treatment and control groups. Changes in serum NGF level and electromyograms before and after treatment were analyzed, and the effects were evaluated via a FACT/GOG-Ntx questionnaire score. Results: After treatment, the NGF level in the treatment group (13.2 ± 3.73 pg/ml) was higher than that in the control group (9.22 ± 2.93 pg/ml, P  < 0.05). Improvements in the electromyograms were more pronounced in treatment group than those in the control group, with statistical significance. The FACT/GOG-Ntx questionnaire scores, both in the treatment group and the control group, were decreased (4.00 ± 1.58 vs. 5.20 ± 2.33; P  < 0.05), and the alleviation of the symptoms in the treatment group were more obvious. Conclusion: Rat nerve growth factor combined with vitamin B is a safe and effective method for treating peripheral neuropathy in multiple myeloma patients.",2020,"The FACT/GOG-Ntx questionnaire scores, both in the treatment group and the control group, were decreased (4.00 ± 1.58 vs. 5.20 ± 2.33; P  < 0.05), and the alleviation of the symptoms in the treatment group were more obvious. ","['multiple myeloma patients', 'in Jiaxing First Hospital from October 2015 to May 2018', 'Sixty multiple myeloma patients who developed peripheral neuropathy after']","['bortezomib', 'Rat nerve growth factor combined with vitamin B', 'rat nerve growth factor combined with vitamin B', 'bortezomib-based chemotherapy']","['quality of life', 'serum NGF level and electromyograms', 'NGF level', 'FACT/GOG-Ntx questionnaire scores', 'alleviation of the symptoms']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0189479,"The FACT/GOG-Ntx questionnaire scores, both in the treatment group and the control group, were decreased (4.00 ± 1.58 vs. 5.20 ± 2.33; P  < 0.05), and the alleviation of the symptoms in the treatment group were more obvious. ","[{'ForeName': 'Minchao', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Jiaxing University, Jiaxing, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Jiaxing University, Jiaxing, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Jiaxing University, Jiaxing, People's Republic of China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Jiaxing University, Jiaxing, People's Republic of China.""}, {'ForeName': 'Haibing', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Jiaxing University, Jiaxing, People's Republic of China.""}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': ""Malignant Lymphoma Diagnosis and Therapy Center, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Jiaxing University, Jiaxing, People's Republic of China.""}]","Hematology (Amsterdam, Netherlands)",['10.1080/16078454.2020.1784615'] 2002,32567544,Acute effects of sitagliptin on progenitor cells and soluble mediators in newly diagnosed type 2 diabetes
.,"OBJECTIVE Studies have confirmed that endothelial progenitor cells (EPCs) are involved in diabetic complications. The present study assessed the action of the dipeptidyl peptidase-4 inhibitor sitagliptin on EPCs in newly diagnosed type 2 diabetes patients. MATERIALS AND METHODS 60 newly-diagnosed type 2 diabetes patients were randomly divided into three treatment groups: sitagliptin (n = 20), metformin (n = 20), and combination sitagliptin and metformin (n = 20). Patients were treated once daily for 3 days. Before and after each treatment, the number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α)) were determined. RESULTS The number of CD34+KDR+ and CD34+CD133+KDR+ EPCs and concentration of GLP-1, NO, and SDF-1α in sitagliptin and combination groups were both increased (both p < 0.05) but to a greater extent in the combination group (p < 0.05). Pearson correlation analysis and multiple linear regression analyses showed that the change in EPC numbers correlated with changes in peripheral GLP-1, NO, and SDF-1α levels (p < 0.05). CONCLUSION Sitagliptin is able to directly increase the number of peripheral blood EPCs. This direct effect is to be important for lowering vascular risk in early diabetes before macrovascular complications appear.",2020,"Before and after each treatment, the number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α)) were determined. ","['60', 'newly diagnosed type 2 diabetes patients', 'newly-diagnosed type 2 diabetes patients', 'newly diagnosed type 2 diabetes\u2029']","['sitagliptin', 'dipeptidyl peptidase-4 inhibitor sitagliptin', 'metformin', 'combination sitagliptin and metformin']","['number of peripheral blood EPCs', 'peripheral GLP-1, NO, and SDF-1α levels', 'number of CD34+KDR+ and CD34+CD133+KDR+ EPCs and concentration of GLP-1, NO, and SDF-1α', 'number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}]",60.0,0.0215393,"Before and after each treatment, the number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α)) were determined. ","[{'ForeName': 'Murong', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Datong', 'Initials': 'D', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Youmin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203665'] 2003,32567586,Evaluation of the satisfaction of the patient undergoing screening colonoscopy and quality of the procedure.,"Background Screening colonoscopy requires quality parameters to determine its efficacy to detect cancerous or precancerous lesions. Limitations of the procedure are the patient's rejection, difficulty for its preparation or lack of preparation. Objective To assess whether patient satisfaction correlates with the quality of the procedure. Method 100 consecutive patients for a screening colonoscopy were included, they were randomized to use a preparation with polyethylene glycol (PEG) or sodium picosulfate (P). In addition, a second parameter evaluated was related to a follow-up phone call performed to half of the patients prior to the study, during the preparation time. Results P was better tolerated and qualified, however, there was no difference with the quality of preparation, adenomatous polyps detection rate, cecum insertion rate and patient satisfaction. A difference was found in whom had a follow-up phone call. Discussion A good colon preparation is a key factor to have a quality colonoscopy, and it has been shown important that a good relationship for explain the doubts and follow the preparation. Conclusion It was found that the type of preparation and patient follow-up during the study correlate with the quality of the study and patient satisfaction.",2020,"Results P was better tolerated and qualified, however, there was no difference with the quality of preparation, adenomatous polyps detection rate, cecum insertion rate and patient satisfaction.",['100 consecutive patients for a screening colonoscopy'],['polyethylene glycol (PEG) or sodium picosulfate (P'],"['tolerated and qualified', 'quality of preparation, adenomatous polyps detection rate, cecum insertion rate and patient satisfaction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1882982', 'cui_str': 'Screening colonoscopy'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0071042', 'cui_str': 'sodium picosulfate'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0206677', 'cui_str': 'Adenomatous polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",100.0,0.0330608,"Results P was better tolerated and qualified, however, there was no difference with the quality of preparation, adenomatous polyps detection rate, cecum insertion rate and patient satisfaction.","[{'ForeName': 'Óscar T', 'Initials': 'ÓT', 'LastName': 'Teramoto-Matsubara', 'Affiliation': 'Clínica Gástrica, Centro Avanzado en Endoscopia y Estudios Funcionales. Ciudad de México, México.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Abdo-Francis', 'Affiliation': 'Clínica Gástrica, Centro Avanzado en Endoscopia y Estudios Funcionales. Ciudad de México, México.'}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Mateos-Pérez', 'Affiliation': 'Clínica Gástrica, Centro Avanzado en Endoscopia y Estudios Funcionales. Ciudad de México, México.'}, {'ForeName': 'Graciela', 'Initials': 'G', 'LastName': 'Morales', 'Affiliation': 'Clínica Gástrica, Centro Avanzado en Endoscopia y Estudios Funcionales. Ciudad de México, México.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sobrino-Cossío', 'Affiliation': 'Clínica Gástrica, Centro Avanzado en Endoscopia y Estudios Funcionales. Ciudad de México, México.'}]",Cirugia y cirujanos,['10.24875/CIRU.20001666'] 2004,32555027,Effects of Land- vs Water-Walking Interventions on Vascular Function in Older Adults.,"PURPOSE Endothelial dysfunction is an early and integral atherogenic event. Interventions that improve endothelial function also reduce cardiovascular risk. Due largely to the direct hemodynamic effects of repetitive exercise on the artery wall, exercise training has shown to enhance endothelial function. Land-walking (LW) and water-walking (WW) induce distinct hemodynamic responses, so comparison of their impacts provides an approach to study shear stress effects on endothelial function. We hypothesized that LW and WW training would have different impacts on peripheral artery endothelial function. METHODS Fifty-one sedentary, older (age 61.9 ± 6.6 yrs, 23.5% male) individuals were randomized into 1 of 3 groups: control (CG, n=16), or one of two exercise groups consisting of 3 x 50 min supervised and individually tailored walking sessions per week for 24 consecutive weeks, performed either on land (LW, n=17) or in water (WW, n=18). Brachial artery endothelial function (flow mediated dilation FMD) and smooth muscle cell function (glyceryl trinitrate GTN administration) was tested in all participants before (Week 0) and after (Week 24) the intervention. RESULTS Differences were apparent in FMD change between the LW (Week 0: 5.39 ± 0.71% to Week 24: 7.77 ± 0.78%, P = 0.009) vs CG (Week 0: 5.87 ± 0.73% to Week 24: 5.78 ± 0.78%) groups. No differences in artery dilation response were found following GTN administration (all P >0.05). CONCLUSION This study suggests that 6 month centre-based LW may be superior to WW in terms of improvement in arterial endothelial function in older sedentary individuals.",2020,"No differences in artery dilation response were found following GTN administration (all P >0.05). ","['sedentary, older (age 61.9 ± 6.6 yrs, 23.5% male) individuals', 'older sedentary individuals', 'Older Adults', 'Fifty-one']","['LW and WW training', 'glyceryl trinitrate GTN administration', 'GTN', 'repetitive exercise', 'exercise groups consisting of 3 x 50 min supervised and individually tailored walking sessions', 'Land- vs Water-Walking Interventions', 'Land-walking (LW) and water-walking (WW']","['endothelial function', 'cardiovascular risk', 'Vascular Function', 'artery dilation response', 'Brachial artery endothelial function (flow mediated dilation FMD) and smooth muscle cell function ', 'peripheral artery endothelial function', 'FMD change', 'arterial endothelial function']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0078589', 'cui_str': 'X 50'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C1135918', 'cui_str': 'Smooth Muscle Cells'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",51.0,0.0163905,"No differences in artery dilation response were found following GTN administration (all P >0.05). ","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Spence', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Robey', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Maslen', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Carter', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lund and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002439'] 2005,32555148,Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial.,"BACKGROUND/OBJECTIVES To ascertain the effect on body weight of 14 days of bolus enteral feeding with mixed meal (MM) and electrolyte solution (ES) in ambulatory adults with type 2 diabetes and obesity, and also the safety and feasibility of using a modified, intraorally anchored enteral feeding tube for this purpose. SUBJECTS/METHODS We conducted a randomized, crossover pilot trial with 16 participants. A 140 cm, 8-French feeding tube was placed in the jejunum under electromagnetic guidance and anchored intraorally. Participants were randomized to self-administer 120 mL 523 kJ (125 kcal) MM, or 50 kJ (12 kcal) ES four times/day for 14 days. After ≥14 days without the tube, participants crossed over to the other treatment. The primary outcome compared weight change between treatments. Thereafter, participants could elect to undergo additional MM cycles. Participants were encouraged to continue with all usual activities including eating ad lib throughout the study. RESULTS Ten participants withdrew prior to completing two randomized 14-day cycles (4 social, 3 intolerant of anchor, and 3 intolerant of tube). Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082). For the secondary outcome of within-group weight loss, average weight loss from baseline was significant for MM but not for ES: -2.40 kg (95% CI: -3.78, -1.02; p = 0.008) vs. -0.64 kg (95% CI: -2.01, 0.74; p = 0.27). A total of 23 2-week cycles were completed (12 paired, 2 unpaired, and 9 additional), with no significant adverse events for 334 days of tube use. CONCLUSIONS Repeated bolus nutrient administration via enteral feeding tube is associated with weight loss in adults with obesity and type 2 diabetes, with no significant difference seen between MM and ES feeds. The prototype device was safe, but requires development for further investigation into the effect of bolus jejunal feeding on weight and to improve acceptability.",2020,Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082).,"['adults with obesity and type 2 diabetes', 'ambulatory adults with obesity and type 2 diabetes', 'ambulatory adults with type 2 diabetes and obesity', '16 participants']","['bolus enteral tube feeding', 'bolus enteral feeding with mixed meal (MM) and electrolyte solution (ES']","['body weight', 'weight loss', 'weight loss, average weight loss', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",6.0,0.0865442,Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082).,"[{'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA. beale@usc.edu.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soffer', 'Affiliation': 'Division of Gastroenterology, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Crookes', 'Affiliation': 'Division of Foregut Surgery, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eagilen', 'Affiliation': 'Edward R. Roybal Comprehensive Health Center Dental Clinic, East Los Angeles, 90022, CA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Edward R. Roybal Comprehensive Health Center Dental Clinic, East Los Angeles, 90022, CA, USA.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tong', 'Affiliation': 'Herman Ostrow School of Dentistry University of Southern California, Los Angeles, 90033, CA, USA.'}]",Nutrition & diabetes,['10.1038/s41387-020-0125-6'] 2006,32555211,The effects of environmental enrichment on skin barrier recovery in humans: a randomised trial.,"This study investigated whether environmental enrichment (EE) could reduce stress and improve wound healing in humans. 120 participants underwent a standardised tape-stripping procedure and were then randomised to interact for 30 minutes with one of three EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group. Skin barrier recovery (SBR) was measured using transepidermal water loss at baseline, after tape-stripping and after the intervention. Psychological variables, cortisol and alpha-amylase were measured at the three time-points. SBR did not significantly differ between the EE conditions and the control condition. The music condition had higher stimulation levels than the control condition, and the comfort condition had significantly lower relaxation levels than the control condition after the intervention. The EE interventions tested were not beneficial for wound healing compared to a control group. Limitations were that the sample were not stressed and an active control condition was used.",2020,SBR did not significantly differ between the EE conditions and the control condition.,"['120 participants underwent a', 'humans']","['environmental enrichment (EE', 'standardised tape-stripping procedure', 'environmental enrichment', 'EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group']","['stimulation levels', 'SBR', 'skin barrier recovery', 'Skin barrier recovery (SBR', 'wound healing', 'relaxation levels', 'Psychological variables, cortisol and alpha-amylase']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}]",120.0,0.0391175,SBR did not significantly differ between the EE conditions and the control condition.,"[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jarrett', 'Affiliation': 'Department of Dermatology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Skoluda', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. e.broadbent@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-66687-2'] 2007,32555432,Touching the social robot PARO reduces pain perception and salivary oxytocin levels.,"Human-human social touch improves mood and alleviates pain. No studies have so far tested the effect of human-robot emotional touch on experimentally induced pain ratings, on mood and on oxytocin levels in healthy young adults. Here, we assessed the effect of touching the robot PARO on pain perception, on mood and on salivary oxytocin levels, in 83 young adults. We measured their perceived pain, happiness state, and salivary oxytocin. For the 63 participants in the PARO group, pain was assessed in three conditions: Baseline, Touch (touching PARO) and No-Touch (PARO present). The control group (20 participants) underwent the same measurements without ever encountering PARO. There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group. The Touch condition yielded a larger decrease in pain ratings compared to No-Touch. These effects correlated with the participants' positive perceptions of the interaction with PARO. Participants with higher perceived ability to communicate with PARO experienced a greater hypoalgesic effect when touching PARO. We show that human-robot social touch is effective in reducing pain ratings, improving mood and - surprisingly - reducing salivary oxytocin levels in adults.",2020,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"['63 participants in the PARO group', 'adults', '83 young adults', 'healthy young adults']",['Human-human social touch'],"['salivary oxytocin levels', 'pain ratings and in oxytocin levels', 'mood and alleviates pain', 'perceived pain, happiness state, and salivary oxytocin', 'pain perception, on mood and on salivary oxytocin levels', 'pain', 'happiness ratings', 'pain ratings', 'pain perception and salivary oxytocin levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",83.0,0.0710033,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"[{'ForeName': 'Nirit', 'Initials': 'N', 'LastName': 'Geva', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Florina', 'Initials': 'F', 'LastName': 'Uzefovsky', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Levy-Tzedek', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. shelly@bgu.ac.il.'}]",Scientific reports,['10.1038/s41598-020-66982-y'] 2008,32555582,Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial.,"CLINICAL TRIALS REGISTRATION NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",2020,"CLINICAL TRIALS REGISTRATION NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",[],[],[],[],[],[],,0.264659,"CLINICAL TRIALS REGISTRATION NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Bessette', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Jacobs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Heleniak', 'Affiliation': 'Department of Psychology, Columbia University, New York City, NY, United States of America.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Department of Psychiatry, University of Utah, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Watkins', 'Affiliation': 'Mood Disorders Centre, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}]",PloS one,['10.1371/journal.pone.0233539'] 2009,32555624,The consequences of exercise-induced weight loss on food reinforcement. A randomized controlled trial.,"BACKGROUND Obesity remains a primary threat to the health of most Americans, with over 66% considered overweight or obese with a body mass index (BMI) of 25 kg/m2 or greater. A common treatment option many believe to be effective, and therefore turn to, is exercise. However, the amount of weight loss from exercise training is often disappointingly less than expected with greater amounts of exercise not always promoting greater weight loss. Increases in energy intake have been prescribed as the primary reason for this lack of weight loss success with exercise. Research has mostly focused on alterations in hormonal mediators of appetite (e.g.: ghrelin, peptide YY, GLP-1, pancreatic polypeptide, and leptin) that may increase hunger and/or reduce satiety to promote greater energy intake with exercise training. A less understood mechanism that may be working to increase energy intake with exercise is reward-driven feeding, a strong predictor of energy intake and weight status but rarely analyzed in the context of exercise. DESIGN Sedentary men and women (BMI: 25-35 kg/m2, N = 52) were randomized into parallel aerobic exercise training groups partaking in either two or six exercise sessions/week, or sedentary control for 12 weeks. METHODS The reinforcing value of food was measured by an operant responding progressive ratio schedule task (the behavioral choice task) to determine how much work participants were willing to perform for access to a healthy food option relative to a less healthy food option before and after the exercise intervention. Body composition and resting energy expenditure were assessed via DXA and indirect calorimetry, respectively, at baseline and post testing. RESULTS Changes in fat-free mass predicted the change in total amount of operant responding for food (healthy and unhealthy). There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition. CONCLUSION In support of previous work, reductions in fat-free mass resulting from an aerobic exercise intervention aimed at weight loss plays an important role in energy balance regulation by increasing operant responding for food.",2020,"There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition. ","['health of most Americans, with over 66% considered overweight or obese with a body mass index (BMI) of 25 kg/m2 or greater', 'BMI', 'N = 52', 'Sedentary men and women']","['aerobic exercise intervention', 'parallel aerobic exercise training groups partaking in either two or six exercise sessions/week, or sedentary control for 12 weeks']","['Body composition and resting energy expenditure', 'weight loss', 'total amount of operant responding for food (healthy and unhealthy']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",52.0,0.0679676,"There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition. ","[{'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Flack', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}, {'ForeName': 'Harry M', 'Initials': 'HM', 'LastName': 'Hays', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moreland', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}]",PloS one,['10.1371/journal.pone.0234692'] 2010,32555681,Improving measles vaccine uptake rates in Nigeria: An RCT evaluating the impact of incentive sizes and reminder calls on vaccine uptake.,"OBJECTIVE To assess the impact of increasing incentive size and reminder calls on the measles vaccine uptake rate. DESIGN Randomized controlled trial, randomized at individual level, stratified by clinic. SETTING Nigeria. PARTICIPANTS 1088 caregivers with children aged nine months or older; had received at least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number. INTERVENTION Nine clinics were randomized to two models; caregivers in Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN. Caregivers from the respective clinics were then randomized to one of the four arms: 1) control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call. MAIN OUTCOME MEASURE Receipt of measles vaccine as reported on a child health card. RESULTS Overall, there was no clear trend that increasing the incentive amount resulted in an increase in vaccine uptake rates. In Model 1 households, an additional 1000 NGN and 3000 NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively. This increase, however, was only significant for the 3000 NGN increase. On the other hand, in Model 2 households, increasing the incentive by 1000 NGN and 3000 NGN increased the probability by 3.3 (95% CI: -3.8-10.4, p-value = 0.36) and 3.3 (95% CI: -3.7-10.4, p-value = 0.35) percentage points. These increases were not statistically significant. Adding reminder calls to CCTs increased the probability of completing the measles vaccine; caregivers who received reminder calls plus CCTs were 5.1 percentage points more likely to get their children vaccinated (95% CI: 0.50-9.8, p-value = 0.03) compared to those who received CCTs and did not receive a reminder call. These results were largely driven by caregivers who went to clinics in Model 1. CONCLUSION A combination of increasing incentive amounts and reminder calls modestly improves measles immunization rates. However, this program also shows that there is substantial regional heterogeneity in response to both incentives and calls. While one possible conclusion is that a larger incentive and phone reminders are more likely to work in higher income and higher baseline coverage settings, the study is not designed to evaluate this claim. Rather, policymakers could consider experimenting with a similar low-cost calling study as part of the design of other cash transfer programs to identify whether adding reminder phone calls could increase the impact of the program.",2020,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","['Nigeria', '1088 caregivers with children aged nine months or older']","['least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number', 'control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call', 'vaccine', 'Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN', 'CCTs']","['vaccine uptake rates', 'measles immunization rates']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025010', 'cui_str': 'Measles vaccine'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]",9.0,0.319228,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Brownstone', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Connor', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0233149'] 2011,32555695,"Prognostic factors for changes in the timed 4-stair climb in patients with Duchenne muscular dystrophy, and implications for measuring drug efficacy: A multi-institutional collaboration.","The timed 4-stair climb (4SC) assessment has been used to measure function in Duchenne muscular dystrophy (DMD) practice and research. We sought to identify prognostic factors for changes in 4SC, assess their consistency across data sources, and the extent to which prognostic scores could be useful in DMD clinical trial design and analysis. Data from patients with DMD in the placebo arm of a phase 3 trial (Tadalafil DMD trial) and two real-world sources (Universitaire Ziekenhuizen, Leuven, Belgium [Leuven] and Cincinnati Children's Hospital Medical Center [CCHMC]) were analyzed. One-year changes in 4SC completion time and velocity (stairs/second) were analyzed. Prognostic models included age, height, weight, steroid use, and multiple timed function tests and were developed using multivariable regression, separately in each data source. Simulations were used to quantify impacts on trial sample size requirements. Data on 1-year changes in 4SC were available from the Tadalafil DMD trial (n = 92) Leuven (n = 67), and CCHMC (n = 212). Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time). Measures of walking and rising ability contributed important prognostic information for changes in 4SC. In a randomized trial with equal allocation to treatment and placebo, adjustment for such a prognostic score would enable detection (at 80% power) of a treatment effect of 0.25 stairs/second with 100-120 patients, compared to 170-190 patients without prognostic score adjustment. Combining measures of ambulatory function doubled prognostic accuracy for 1-year changes in 4SC completion time and velocity. Randomized clinical trials incorporating a validated prognostic score could reduce sample size requirements by approximately 40%. Knowledge of important prognostic factors can also inform adjusted comparisons to external controls.",2020,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","['patients with Duchenne muscular dystrophy', 'patients with DMD in the']",['placebo'],"['sample size requirements', '4SC completion time and velocity (stairs/second']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",212.0,0.0551207,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Van den Hauwe', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sajeev', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Toronto, Ontario, Canada.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'Analysis Group Inc., London, United Kingdom.'}, {'ForeName': 'Ibrahima', 'Initials': 'I', 'LastName': 'Dieye', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Intekhab', 'Initials': 'I', 'LastName': 'Hossain', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Ward', 'Affiliation': 'The Collaborative Trajectory Analysis Project, Cambridge, Massachusetts, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232870'] 2012,32559123,Highlighting Prosocial Affordances of Science in Textbooks to Promote Science Interest.,"The prevalent stereotype that scientific fields do not afford opportunities to fulfill goals of helping others deters student interest and participation in science. We investigated whether introductory college science textbooks that highlight the prosocial utility value of science can be used to change beliefs about the affordances of scientific work. In study 1, undergraduate students who were randomly assigned to read a science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals and increased interest in the scientific topic, compared with two control conditions. Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities. Multiple group comparison tests indicated that underrepresented minority students (i.e., African Americans, Latinos, and Native Americans) might benefit the most from efforts to strengthen prosocial affordance beliefs. In study 2, we conducted a brief landscape analysis of science textbooks and found that texts are missing opportunities to emphasize the prosocial utility value of science. We discuss recommendations for science educators, curriculum designers, and researchers who want to increase and broaden science participation.",2020,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"['underrepresented minority students (i.e., African Americans, Latinos, and Native Americans', 'undergraduate students']",['science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals'],[],"[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}]","[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",[],,0.0293534,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Zambrano', 'Affiliation': 'Rossier School of Education, University of Southern California, Los Angeles, CA 90089-4035.'}, {'ForeName': 'Garam Ann', 'Initials': 'GA', 'LastName': 'Lee', 'Affiliation': 'College of Education, Michigan State University, East Lansing, MI 48824.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Leal', 'Affiliation': 'Warner School of Education, University of Rochester, Rochester, NY 14627.'}, {'ForeName': 'Dustin B', 'Initials': 'DB', 'LastName': 'Thoman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA 92182.'}]",CBE life sciences education,['10.1187/cbe.19-09-0176'] 2013,32559181,Effect of Parenting Training on Neurobehavioral Development of Infants.,"BACKGROUND Early interventions have been believed to have a positive influence on the neurodevelopment of infants. Our Child Health Center has carried out parenting training for parents of infants for several years to promote the neurobehavioral development of infants at an early stage. MATERIAL AND METHODS We enrolled 117 families with term infants age 0-3 months who had completed a parenting training class at the Child Health Center of the Department of Pediatrics, the Third Xiangya Hospital. Parenting training included 4 parts: nursing, intelligence, social contact, and physical ability. A nurse practitioner demonstrated procedures to parents, who then performed them at home for 1 month. The Neonatal Behavioral Neurological Assessment (NBNA) was used to evaluate infants before and 1 month after parenting training. RESULTS In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores. For the infants whose parents received parenting training, the NBNA scores in total score (33.74±0.19 before parenting training vs. 36.69±0.20 after 1 month), neonatal behavioral capacity (10.19±0.14 before parenting training vs. 11.26±0.10 after 1 month), passive muscle tension (7.28±0.07 before parenting training vs. 7.82±0.04 after 1 month), and initiative muscle tension (4.29±0.08 before the parenting training vs. 5.61±0.13 after 1 month) were significantly higher one month before (P<0.01). CONCLUSIONS Term infant neurobehavior was associated with participation in parenting training, suggesting that these practices of parenting training support better early neurobehavioral development of infants.",2020,"In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores.","['Infants', '117 families with term infants age 0-3 months who had completed a parenting training class at the Child Health Center of the Department of Pediatrics, the Third Xiangya Hospital']","['Parenting Training', 'parenting training']","['NBNA scores in total score', 'NBNA scores', 'passive muscle tension', 'neonatal behavioral capacity', 'Neonatal Behavioral Neurological Assessment (NBNA', 'initiative muscle tension']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]",117.0,0.0160345,"In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores.","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Quyan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Mingyi', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924457'] 2014,32559602,Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2.,"OBJECTIVE To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate. STUDY DESIGN The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here. RESULTS Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified. CONCLUSION Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.",2020,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","['women with ≥1 UF experiencing heavy menstrual bleeding (HMB', 'women with uterine fibroids', 'Women (mean age 42.5 years) were enrolled from 1 June 2015', '155 women completed the initial 12-week treatment period']","['Vilaprisan and ulipristal acetate', 'ulipristal acetate', 'vilaprisan versus placebo and ulipristal acetate', 'vilaprisan', 'placebo']","['mean menstrual blood loss', 'HMB response', 'Efficacy and safety', 'absence of bleeding/spotting by bleeding diary', 'Complete absence of bleeding/spotting', 'efficacy and safety', 'amenorrhea, controlled bleeding, decreased UF size', 'efficacy of vilaprisan', 'efficacy of vilaprisan with ulipristal acetate', 'absence of bleeding/spotting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}]",155.0,0.413833,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Karolinska University Hospital, S-171 76, Stockholm, Sweden. Electronic address: Kristina.Gemzell@ki.se.""}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029-HUS, Helsinki, Finland. Electronic address: oskari.heikinheimo@helsinki.fi.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zatik', 'Affiliation': 'Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Magan Rendelo, 48 Szent Anna utca, Debrecen, Hungary. Electronic address: jzatik@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen, Nagyerdei krt. 98, 4032, Debrecen, Hungary. Electronic address: pokar@med.unideb.hu.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': 'II Department of Gynecology, Medical University of Lublin, Racławickie 1 Street, 20-059, Lublin, Poland. Electronic address: rechbergt@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hudecek', 'Affiliation': 'Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavská 20, CZ - 625 00, Brno, Czech Republic. Electronic address: hudecek.robert@fnbrno.cz.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Petersdorf', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Kathrin.petersdorf@bayer.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramirez', 'Affiliation': 'Syneos Health, Frankfurter StraBe 233 Triforum, Haus C1 Neu-Isenburg, 63263, Germany. Electronic address: francisco.ramirez1.ext@bayer.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faustmann', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: thomas.faustmann@bayer.com.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Groettrup-Wolfers', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Esther.groettrup-wolfers@bayer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seitz', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Christian.seitz@bayer.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.043'] 2015,32559644,Compensation of stochastic time-continuous perturbations during walking in healthy young adults: An analysis of the structure of gait variability.,"BACKGROUND During everyday locomotion, we cope with various internal or external perturbations (e.g. uneven surface). Uncertainty exists on how unpredictable external perturbations increase noise within the motor system and if they are compensated by employing covariation of the limb joints or rather due to decreased sensitivity of an altered posture. RESEARCH QUESTION Do continuous stochastic perturbations affect the structure of gait variability in young and healthy adults? METHODS In a cross-over study, gait kinematics of 21 healthy young sports students were registered during treadmill walking with and without continuous stochastic perturbations. Using the TNC method, the following aspects were analyzed: (a) the sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints. RESULTS Compared to normal walking, gait variability was significantly increased (p < .001) during walking with perturbations. The negative effect of noise was partly compensated by improved 'covariation' of leg joints (p < .001). The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001). SIGNIFICANCE Increased motor noise due to external perturbations is partly compensated by improved covariation of the limb joints. However, the effect of an altered posture slightly affects gait variability. Further studies should focus on different populations (e.g. older participants) to see if they use the same mechanism (improved covariation) to compensate for stochastic perturbations.",2020,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001). ","['young and healthy adults', '21 healthy young sports students', 'healthy young adults']",['treadmill walking with and without continuous stochastic perturbations'],"[""sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints"", 'gait variability', 'normal walking, gait variability', ""covariation' of leg joints""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",21.0,0.0319459,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001). ","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: mq.koch@gmx.de.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Eckardt', 'Affiliation': 'Department of Sport and Movement Science, Institute of Sport Science, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany; Department for Exercise & Health, Institute of Sport Science, Leibniz University Hannover, Hannover, Germany. Electronic address: nils.eckardt@uni-oldenburg.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: astrid.zech@uni-jena.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: daniel.hamacher@uni-jena.de.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.040'] 2016,32559656,Can theory of mind be improved? Positive expectations cause better theory of mind performance in a community sample.,"BACKGROUND AND OBJECTIVES Theory of Mind (ToM) deficits are present in several mental disorders and closely related to problems in social functioning and lower quality of life. While several trainings are aimed at improving ToM performance, it is unknown whether positive expectations on a persons' ToM performance might cause better ToM achievement. METHODS Participants (n = 131) first completed a mock ToM test and were then randomly assigned to either receive standardized positive, negative or no feedback on their ToM performance. Secondly, their expectations on their own ToM performance were assessed. Thirdly, ToM was assessed using the Movie Task for the Assessment of Social Cognition (MASC). RESULTS Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance. LIMITATIONS In the present exploratory study, the effect of positive expectations on ToM performance was assessed in a community sample. Thus, the study should be replicated in a clinical sample for more in-depth results. CONCLUSIONS ToM performance could be enhanced by inducing positive expectations on one's ToM performance, whereas negative feedback had no effect. The present study suggest that interventions that focus on strengthening positive expectations on one's ToM performance could enhance the efficacy of present ToM training methods.",2020,"RESULTS Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance. ",['Participants (n\xa0'],"['standardized positive, negative or no feedback on their ToM performance']","['Movie Task for the Assessment of Social Cognition (MASC', 'enhanced ToM performance', 'ToM performance']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]",131.0,0.0319971,"RESULTS Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance. ","[{'ForeName': 'Laura M-L', 'Initials': 'LM', 'LastName': 'Dorn', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany. Electronic address: laura.dorn@staff.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University, Marburg, Germany; Department of Social Work and Health, Frankfurt University of Applied Sciences, Germany.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101577'] 2017,32559669,A novel digital health intervention to improve patient engagement to stimulants in adult ADHD in the primary care setting: Preliminary findings from an open label study.,"AIMS We piloted the effectiveness and acceptability of a novel text messaging-based (SMS) digital health intervention aimed at addressing the previously documented poor rate of patient engagement in stimulant treatment in the primary care setting. METHODS 117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the SMS intervention. Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period. Using documented prescription records, we determined whether patients had timely prescription refills. RESULTS Ninety-six percent (N = 112) of participants completed our a priori metric of patient engagement consisting of 37 days of the SMS program. Eighty-one percent of participants refilled their index prescriptions in a timely manner compared to only 36% of patients receiving treatment as usual (OR=7.54, 95% CI: 4.46, 12.77; p<0.001). We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual). CONCLUSIONS These data suggest that an ADHD-centric, digital health intervention using text messaging significantly improves patient engagement in stimulant treatment in adults with ADHD.",2020,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual). ","[""Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period"", 'adults with ADHD', 'adult ADHD in the primary care setting', '117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the']","['SMS intervention', 'digital health intervention', 'novel text messaging-based (SMS) digital health intervention']",['patient engagement'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}]",117.0,0.0801889,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual). ","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA. Electronic address: jbiederman@partners.org.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Driscoll', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'K Yvonne', 'Initials': 'KY', 'LastName': 'Woodworth', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113158'] 2018,32559716,A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.,"OBJECTIVE Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia. METHODS Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth. RESULTS From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed. CONCLUSIONS Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.",2020,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","['insomnia (CBTI) for prenatal insomnia', 'pregnant women with insomnia', '91 pregnant women (29.03\xa0±\xa04.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI', 'pregnant women']","['Digital CBTI', 'digital CBTI or digital sleep education control', 'digital cognitive behavioral therapy', 'face-to-face cognitive-behavioral therapy', 'NAME']","['nightly sleep duration', 'PSQI', 'sleep quality and sleep duration', 'sleep maintenance', 'ISI', 'depression or cognitive arousal', ""ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C"", 'Sleep symptoms', 'Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",91.0,0.126542,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Roopina', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Department of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.016'] 2019,32559734,"Effects of low fructose diet on glycemic control, lipid profile and systemic inflammation in patients with type 2 diabetes: A single-blind randomized controlled trial.","BACKGROUND AND AIM Type 2 diabetes is one of the global epidemic disorders, which causes many side effects on the body. Fructose is a lipogenic monosaccharide. Recent studies have reported the adverse effects of this carbohydrate on diabetes. This study aimed to evaluate the clinical efficacy of a low-fructose diet on the metabolic alterations in patients with type 2 diabetes. METHODS This study was a randomized, single-blind clinical trial on 50 patients with type 2 diabetes. Participants randomly allocated to two groups, to receive either diabetic-diet or diabetic-diet with low-fructose for 8-weeks. Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors were assessed at baseline and the end of the trial. RESULTS At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013). Statistical analysis showed that low-fructose diet compared to control group significantly declined fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP) (P = 0.015, P = 0.001, P=<0.0001, P= <0.0001 and P= <0.0001 respectively). CONCLUSION Our results showed that eight weeks of low-fructose diet results in a significant improvement in FBG, HbA1c, TG, HDL-C and hs-CRP in patients with type 2 diabetes.",2020,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","['50 patients with type 2 diabetes', 'patients with type 2 diabetes']","['diabetic-diet or diabetic-diet with low-fructose for 8-weeks', 'low-fructose diet', 'Fructose', 'low fructose diet']","['fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP', 'Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors', 'glycemic control, lipid profile and systemic inflammation', 'body weight, waist circumference, and blood pressure', 'metabolic alterations', 'FBG, HbA1c, TG, HDL-C and hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452314', 'cui_str': 'Low fructose diet'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",50.0,0.074236,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Jalilvand', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran. Electronic address: golbonsohrab@yahoo.com.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.003'] 2020,32559735,Improving clinical outcomes of diabetic foot ulcers by the 3-month self- and family management support programs in Indonesia: A randomized controlled trial study.,"BACKGROUND AND AIMS Diabetic foot ulcers are the leading cause of lower extremity amputations, which require more effective prevention. Even though previous nursing studies on diabetic foot ulcers have been well performed, programs implementing self- and family management are limited and even underexplored. Therefore, the purpose of the study was to investigate the effect of 3-month self- and family management support programs on clinical outcomes among Indonesians with diabetic foot ulcers. METHOD The randomized controlled trial design was used to answer the research question of the study. A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group. The experimental group received self- and family management support programs for three months. Meanwhile, the control group received usual care. Descriptive statistics, multivariate analysis of variance, and Generalized Estimating Equations were used to analyze the data. The significance level was considered at .05 for hypothesis testing. RESULTS The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05). CONCLUSIONS With regard to the result of the study, implementing the 3-month self- and family management support programs improves the patients' and families' abilities to perform diabetic foot ulcer care at home.",2020,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05). ","['A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group', 'Indonesia', 'Indonesians with diabetic foot ulcers']","['usual care', 'self- and family management support programs']","['self-management, family supports, hemoglobin A1c, and wound size']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",56.0,0.0239313,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05). ","[{'ForeName': 'Sumarno Adi', 'Initials': 'SA', 'LastName': 'Subrata', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand; Department of Nursing and Wound Research Center, Faculty of Health Sciences, Universitas Muhammadiyah Magelang, Indonesia.'}, {'ForeName': 'Rutja', 'Initials': 'R', 'LastName': 'Phuphaibul', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: ruja.phu@mahidol.ac.th.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grey', 'Affiliation': 'Yale University School of Nursing, United States.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Siripitayakunkit', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Noppawan', 'Initials': 'N', 'LastName': 'Piaseu', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.028'] 2021,32559759,Short-term nicotine deprivation alters dorsal anterior cingulate glutamate concentration and concomitant cingulate-cortical functional connectivity.,"Most cigarette smokers who wish to quit too often relapse within the first few days of abstinence, primarily due to the aversive aspects of the nicotine withdrawal syndrome (NWS), which remains poorly understood. Considerable research has suggested that the dorsal anterior cingulate cortex (dACC) plays a key role in nicotine dependence, with its functional connections between other brain regions altered as a function of trait addiction and state withdrawal. The flow of information between dACC and fronto-striatal regions is secured through different pathways, the vast majority of which are glutamatergic. As such, we investigated dACC activity using resting state functional connectivity (rsFC) with functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS). We also investigated the changes in adenosine levels in plasma during withdrawal as a surrogate for brain adenosine, which plays a role in fine-tuning synaptic glutamate transmission. Using a double-blind, placebo-controlled, randomized crossover design, nontreatment seeking smoking participants (N = 30) completed two imaging sessions, one while nicotine sated and another after 36 h nicotine abstinence. We observed reduced dACC Glu (P = 0.029) along with a significant reduction in plasma adenosine (P = 0.03) and adenosine monophosphate (AMP; P < 0.0001) concentrations during nicotine withdrawal in comparison with nicotine sated state. This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG). Moreover, the state-trait changes in dACC Glu and rsFC strength between the dACC and both SFG and MFG were positively correlated (P = 0.012, and P = 0.007, respectively). Finally, the change in circuit strength between dACC and LSFG was negatively correlated with the change in withdrawal symptom manifestations as measured by the Wisconsin Smoking Withdrawal Scale (P = 0.04) and Tobacco Craving Questionnaire (P = 0.014). These multimodal imaging-behavioral findings reveal the complex cascade of changes induced by acute nicotine deprivation and call for further investigation into the potential utility of adenosine- and glutamate-signaling as novel therapeutic targets to treat the NWS.",2020,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).",['nontreatment seeking smoking participants (N\u2009=\u200930) completed two'],"['placebo', 'Short-term nicotine deprivation', 'imaging sessions, one while nicotine sated and another after 36\u2009h nicotine abstinence', 'functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS']","['plasma adenosine', 'left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG', 'Wisconsin Smoking Withdrawal Scale', 'dACC Glu', 'dACC Glu and rsFC strength', 'rsFC strength', 'withdrawal symptom manifestations', 'circuit strength', 'Tobacco Craving Questionnaire']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0275209,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Abulseoud', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA. osama.abulseoud@nih.gov.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hyung Wook', 'Initials': 'HW', 'LastName': 'Nam', 'Affiliation': 'Department of Pharmacology, Toxicology and Neuroscience, LSU Health Sciences Center, Shreveport, LA, USA.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'Caparelli', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tennekoon', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Schleyer', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fedota', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0741-9'] 2022,32568123,Kangaroo mother care can improve the short-term outcomes of very preterm infants.,"BACKGROUND Kangaroo mother care (KMC) is a cornerstone of preterm infant management. The purpose of this study was to estimate the effectiveness of daily prolonged KMC in very preterm infants and its influence on neonatal morbidity and short-term outcomes, and breastfeeding optimization. METHODS Research included 52 very preterm infants. According to the KMC duration newborns were divided into two groups; Group1 of 22 infants (42.3%) - KMC lasted more than 3 hours/day, Group 2 of 30 infants (57.7%) - KMC lasted less than 3 hours/day. RESULTS Nosocomial sepsis occurred less frequently in Group 1 versus Group 2 (OR = 10.50; 95% CI 1.23-89.67, p = 0.012). Incidences of BPD, NEC, IVH I-II grades, the duration of parenteral nutrition, and growth parameters have not been different between groups (p >  0.05). Breastfeeding rates at discharge prevailed in Group 1 (OR = 3.70; 95% CI 1.16-11.86, p = 0.025). The most important factors for nosocomial sepsis: combination of parenteral nutrition duration and daily prolonged KMC, as a preventing factor (p = 0.002). Combination of the neonatal intensive care unit (NICU) treatment duration, type of enteral feeding, and mother's age add as factors that have important influence on breastfeeding prolongation (p = 0.009). CONCLUSION Nosocomial infection prevention and breastfeeding optimization are profitable outcomes of daily prolonged KMC in very preterm infants. No significant differences in the BPD, NEC, IVH I-II grades incidences, duration of parenteral nutrition, and growth parameters were found between studied groups. Combination of long-lasting KMC and short-term parenteral nutritionis a significant factor for nosocomial sepsis prophylaxis.",2020,"Breastfeeding rates at discharge prevailed in Group 1 (OR = 3.70; 95% CI 1.16-11.86, p = 0.025).","['very preterm infants', '52 very preterm infants']","['neonatal intensive care unit (NICU', 'Kangaroo mother care (KMC', 'long-lasting KMC and short-term parenteral nutritionis']","['BPD, NEC, IVH I-II grades incidences, duration of parenteral nutrition, and growth parameters', 'neonatal morbidity and short-term outcomes, and breastfeeding optimization', 'Breastfeeding rates', 'Nosocomial sepsis', 'Incidences of BPD, NEC, IVH I-II grades, the duration of parenteral nutrition, and growth parameters', 'breastfeeding prolongation']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",52.0,0.0374709,"Breastfeeding rates at discharge prevailed in Group 1 (OR = 3.70; 95% CI 1.16-11.86, p = 0.025).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pavlyshyn', 'Affiliation': 'I. Horbachevsky Ternopil National Medical University, Ternopil, Ukraine.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sarapuk', 'Affiliation': 'I. Horbachevsky Ternopil National Medical University, Ternopil, Ukraine.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Casper', 'Affiliation': 'Université Toulouse III Paul-Sabatier, Toulouse, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Makieieva', 'Affiliation': 'Kharkiv National Medical University, Kharkiv, Ukraine.'}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-200455'] 2023,32568128,"The effects of the three-dimensional active trunk training exercise on trunk control ability, trunk muscle strength, and balance ability in sub-acute stroke patients: A randomized controlled pilot study.","BACKGROUND Trunk control ability has been identified as an important early predictor of functional recovery after stroke. OBJECTIVE Our study aimed to investigate the effects of three-dimensional active trunk training exercise on trunk control ability, trunk muscle strength, and balance ability in sub-acute stroke patients. METHODS Twenty-four sub-acute stroke patients were randomly assigned to an experimental (n= 12) or control (n= 12) group. The experimental group (EG) performed three-dimensional active trunk training exercises using the Space Balance 3D system, while the control group (CG) performed only general trunk training exercises five times per week, for a total of three weeks. The Trunk Impairment Scale (TIS), trunk muscle strength, balance ability using the Space Balance 3D system, and Brunel Balance Assessment (BBA) scores were assessed before and after the intervention. RESULTS Pre-to-post intervention improvement was noted in all outcome measures for both groups (p< 0.05). Post intervention, the TIS, trunk muscle strength, static balance, and BBA scores were significantly higher in the EG than those in the CG (p< 0.05). CONCLUSION Our study suggests that the three-dimensional active trunk training exercise may be more effective compared to the general trunk training exercise in improving trunk control ability, trunk muscle strength, and balance ability in sub-acute stroke patients.",2020,"Post intervention, the TIS, trunk muscle strength, static balance, and BBA scores were significantly higher in the EG than those in the CG (p< 0.05). ","['sub-acute stroke patients', 'Twenty-four sub-acute stroke patients']","['dimensional active trunk training exercises using the Space Balance 3D system, while the control group (CG) performed only general trunk training exercises', 'dimensional active trunk training exercise']","['TIS, trunk muscle strength, static balance, and BBA scores', 'trunk control ability, trunk muscle strength, and balance ability', 'Trunk Impairment Scale (TIS), trunk muscle strength, balance ability using the Space Balance 3D system, and Brunel Balance Assessment (BBA) scores']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1960377', 'cui_str': 'Assessment of sense of balance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",,0.0149419,"Post intervention, the TIS, trunk muscle strength, static balance, and BBA scores were significantly higher in the EG than those in the CG (p< 0.05). ","[{'ForeName': 'Kyeoung-Man', 'Initials': 'KM', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, Won-Kwang University Hospital, Iksan, Korea.'}, {'ForeName': 'Min-Cheol', 'Initials': 'MC', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Won-Kwang University School of Medicine, Iksan, Korea.'}, {'ForeName': 'You-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, Won-Kwang University Hospital, Iksan, Korea.'}, {'ForeName': 'Woo-Nam', 'Initials': 'WN', 'LastName': 'Jang', 'Affiliation': 'Department of Physical Therapy, College of Health Welfare, Yong-In University, Yongin, Korea.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-181179'] 2024,32568136,Fracture resistance of endodontically treated teeth restored with various esthetic posts.,"BACKGROUND Dental esthetic materials are constantly introduced to meet the increasing esthetic demand in contemporary dental practice. OBJECTIVE To test the fracture resistance of endodontically treated teeth (ETT) restored with different esthetic post materials like fiber-reinforced composite post (FRC), polyether ether ketone (PEEK), and polymer infiltrated ceramic (PIC). METHODS Thirty-six human root canal treated single-rooted premolar teeth were decoronated 3 mm above the cemento-enamel junction and prepared to receive the post. They were randomly divided into three groups (n= 12) to be restored with FRC, PEEK, and PIC. After appropriate surface treatment, they were cemented with self-adhesive luting cement and restored with full veneer crowns. The samples were thermocycled, subjected to a compressive static load at 45∘ angulation until fracture. Obtained data were analyzed by one-way ANOVA and Tukey's HSD post hoc comparison test. RESULTS The results indicate that the ETT restored with PEEK post had the maximum fracture load (1929.94 N), followed by PIC endodontic post group (1810.65N), and FRC post (1715.68N). Meanwhile, ETT restored with FRC showed a predominantly favorable fracture, whereas PEEK restored teeth had a more unfavorable fracture. CONCLUSION Of all the esthetic post materials, the group for which PEEK endodontic post was used displayed higher fracture resistance.",2020,the group for which PEEK endodontic post was used displayed higher fracture resistance.,['Thirty-six human root canal treated single-rooted premolar teeth'],"['FRC, PEEK, and PIC', 'various esthetic posts', 'esthetic post materials like fiber-reinforced composite post (FRC), polyether ether ketone (PEEK), and polymer infiltrated ceramic (PIC']","['Fracture resistance', 'unfavorable fracture', 'fracture resistance']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0014994', 'cui_str': 'ethyl ether'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",36.0,0.0169885,the group for which PEEK endodontic post was used displayed higher fracture resistance.,"[{'ForeName': 'Satheesh B', 'Initials': 'SB', 'LastName': 'Haralur', 'Affiliation': ''}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-202228'] 2025,32568139,Acute effects of moderate-intensity cycling exercise on endothelial function in young healthy men: An investigation using the reactive hyperemia index.,"BACKGROUND Endothelial cells play an important role in the prevention of cardiovascular disease. OBJECTIVE In this study, we examined the effects of transient aerobic exercise on peripheral endothelial function. METHODS Twenty-seven healthy male college students were selected as subjects and randomly divided into two groups: 13 in the control group and 14 in the exercise group. The subjects in the exercise group had a 15-minute supine rest, followed by 30 minutes of cycling exercise at moderate intensity, while measuring the reactive hyperemia index (RHI), an indicator of endothelial function, before and after exercise. The subjects in the control group had a 40-minute rest, during which RHI was measured with the same timing as in the exercise group. RESULTS Two-factor analysis of variance revealed a statistically significant interaction effect. In the exercise group, RHI increased significantly after exercise. However, no significant change was observed in the control group. When RHI before exercise was compared between the two groups, no significant difference was found. However, RHI after exercise was significantly higher in the exercise group. CONCLUSIONS The results of this study suggest that 30 minutes of moderate-intensity exercise may have a favorable impact on peripheral endothelial function.",2020,"When RHI before exercise was compared between the two groups, no significant difference was found.","['Twenty-seven healthy male college students', 'young healthy men']","['moderate-intensity cycling exercise', 'transient aerobic exercise', '15-minute supine rest, followed by 30 minutes of cycling exercise']","['endothelial function', 'reactive hyperemia index', 'RHI after exercise', 'RHI', 'peripheral endothelial function', 'reactive hyperemia index (RHI']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",27.0,0.0190715,"When RHI before exercise was compared between the two groups, no significant difference was found.","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Koshiba', 'Affiliation': 'Faculty of Health and Well-being, Kansai University, Osaka, Japan.'}, {'ForeName': 'Etsuko', 'Initials': 'E', 'LastName': 'Maeshima', 'Affiliation': 'Graduate School of Sport and Exercise Sciences, Osaka University of Health and Sport Sciences, Osaka, Japan.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-202281'] 2026,32568367,"Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial.","Importance Insulin modulates aspects of brain function relevant to Alzheimer disease and can be delivered to the brain using intranasal devices. To date, the use of intranasal insulin to treat persons with mild cognitive impairment and Alzheimer's disease dementia remains to be examined in a multi-site trial. Objective To examine the feasibility, safety, and efficacy of intranasal insulin for the treatment of persons with mild cognitive impairment and Alzheimer disease dementia in a phase 2/3 multisite clinical trial. Design, Setting, and Participants A randomized (1:1) double-blind clinical trial was conducted between 2014 and 2018. Participants received 40 IU of insulin or placebo for 12 months during the blinded phase, which was followed by a 6-month open-label extension phase. The clinical trial was conducted at 27 sites of the Alzheimer's Therapeutic Research Institute. A total of 432 adults were screened, and 144 adults were excluded. Inclusion criteria included adults aged 55 to 85 years with a diagnosis of amnestic mild cognitive impairment or Alzheimer disease (based on National Institute on Aging-Alzheimer Association criteria), a score of 20 or higher on the Mini-Mental State Examination, a clinical dementia rating of 0.5 or 1.0, and a delayed logical memory score within a specified range. A total of 289 participants were randomized. Among the first 49 participants, the first device (device 1) used to administer intranasal insulin treatment had inconsistent reliability. A new device (device 2) was used for the remaining 240 participants, who were designated the primary intention-to-treat population. Data were analyzed from August 2018 to March 2019. Interventions Participants received 40 IU of insulin (Humulin-RU-100; Lilly) or placebo (diluent) daily for 12 months (blinded phase) followed by a 6-month open-label extension phase. Insulin was administered with 2 intranasal delivery devices. Main Outcomes and Measures The primary outcome (mean score change on the Alzheimer Disease Assessment Scale-cognitive subscale 12) was evaluated at 3-month intervals. Secondary clinical outcomes were assessed at 6-month intervals. Cerebrospinal fluid collection and magnetic resonance imaging scans occurred at baseline and 12 months. Results A total of 289 participants (155 men [54.6%]; mean [SD] age, 70.9 [7.1] years) were randomized. Of those, 260 participants completed the blinded phase, and 240 participants completed the open-label extension phase. For the first 49 participants, the first device used to administer treatment had inconsistent reliability. A second device was used for the remaining 240 participants (123 men [51.3%]; mean [SD] age, 70.8 [7.1] years), who were designated the primary intention-to-treat population. No differences were observed between treatment arms for the primary outcome (mean score change on ADAS-cog-12 from baseline to month 12) in the device 2 ITT cohort (0.0258 points; 95% CI, -1.771 to 1.822 points; P = .98) or for the other clinical or cerebrospinal fluid outcomes in the primary (second device) intention-to-treat analysis. No clinically important adverse events were associated with treatment. Conclusions and Relevance In this study, no cognitive or functional benefits were observed with intranasal insulin treatment over a 12-month period among the primary intention-to-treat cohort. Trial Registration ClinicalTrials.gov Identifier: NCT01767909.",2020,"No differences were observed between treatment arms for the primary outcome (mean score change on ADAS-cog-12 from baseline to month 12) in the device 2 ITT cohort (0.0258 points; 95% CI, -1.771 to 1.822 points; P = .98) or for the other clinical or cerebrospinal fluid outcomes in the primary (second device) intention-to-treat analysis.","['Mild Cognitive Impairment and Alzheimer Disease Dementia', '289 participants (155 men [54.6%]; mean [SD] age, 70.9 [7.1] years', '289 participants were randomized', 'mean [SD] age, 70.8 [7.1] years), who were designated the primary intention-to-treat population', 'persons with mild cognitive impairment and Alzheimer disease dementia in a phase 2/3 multisite clinical trial', '240 participants (123 men [51.3', ""27 sites of the Alzheimer's Therapeutic Research Institute"", 'Inclusion criteria included adults aged 55 to 85 years with a diagnosis of amnestic mild cognitive impairment or Alzheimer disease (based on National Institute on Aging-Alzheimer Association criteria), a score of 20 or higher on the Mini-Mental State Examination, a clinical dementia rating of 0.5 or 1.0, and a delayed logical memory score within a specified range', '240 participants, who were designated the primary intention-to-treat population', '260 participants completed the blinded phase, and 240 participants completed the open-label extension phase', ""persons with mild cognitive impairment and Alzheimer's disease dementia"", 'A total of 432 adults were screened, and 144 adults were excluded']","['Insulin', 'Intranasal Insulin', '40 IU of insulin (Humulin-RU-100; Lilly) or placebo (diluent', '40 IU of insulin or placebo', 'intranasal insulin']","['Cerebrospinal fluid collection and magnetic resonance imaging scans', 'Safety, Efficacy, and Feasibility', 'Alzheimer Disease Assessment Scale-cognitive subscale 12', 'feasibility, safety, and efficacy']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0282334', 'cui_str': 'Human Experimentation, Therapeutic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1955974', 'cui_str': 'NIA (US)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0020172', 'cui_str': 'Humulin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0394552', 'cui_str': 'Cerebrospinal fluid collection'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}]",289.0,0.580836,"No differences were observed between treatment arms for the primary outcome (mean score change on ADAS-cog-12 from baseline to month 12) in the device 2 ITT cohort (0.0258 points; 95% CI, -1.771 to 1.822 points; P = .98) or for the other clinical or cerebrospinal fluid outcomes in the primary (second device) intention-to-treat analysis.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Department of Internal Medicine-Geriatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Tiffany W', 'Initials': 'TW', 'LastName': 'Chow', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Rafii', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Chung-Kai', 'Initials': 'CK', 'LastName': 'Sun', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rissman', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Donohue', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Brewer', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Jenkins', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Harless', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Gessert', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Aisen', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego.""}]",JAMA neurology,['10.1001/jamaneurol.2020.1840'] 2027,32568399,Evaluation of a Machine Learning Model Based on Pretreatment Symptoms and Electroencephalographic Features to Predict Outcomes of Antidepressant Treatment in Adults With Depression: A Prespecified Secondary Analysis of a Randomized Clinical Trial.,"Importance Despite the high prevalence and potential outcomes of major depressive disorder, whether and how patients will respond to antidepressant medications is not easily predicted. Objective To identify the extent to which a machine learning approach, using gradient-boosted decision trees, can predict acute improvement for individual depressive symptoms with antidepressants based on pretreatment symptom scores and electroencephalographic (EEG) measures. Design, Setting, and Participants This prognostic study analyzed data collected as part of the International Study to Predict Optimized Treatment in Depression, a randomized, prospective open-label trial to identify clinically useful predictors and moderators of response to commonly used first-line antidepressant medications. Data collection was conducted at 20 sites spanning 5 countries and including 518 adult outpatients (18-65 years of age) from primary care or specialty care practices who received a diagnosis of current major depressive disorder between December 1, 2008, and September 30, 2013. Patients were antidepressant medication naive or willing to undergo a 1-week washout period of any nonprotocol antidepressant medication. Statistical analysis was conducted from January 5 to June 30, 2019. Exposures Participants with major depressive disorder were randomized in a 1:1:1 ratio to undergo 8 weeks of treatment with escitalopram oxalate (n = 162), sertraline hydrochloride (n = 176), or extended-release venlafaxine hydrochloride (n = 180). Main Outcomes and Measures The primary objective was to predict improvement in individual symptoms, defined as the difference in score for each of the symptoms on the 21-item Hamilton Rating Scale for Depression from baseline to week 8, evaluated using the C index. Results The resulting data set contained 518 patients (274 women; mean [SD] age, 39.0 [12.6] years; mean [SD] 21-item Hamilton Rating Scale for Depression score improvement, 13.0 [7.0]). With the use of 5-fold cross-validation for evaluation, the machine learning model achieved C index scores of 0.8 or higher on 12 of 21 clinician-rated symptoms, with the highest C index score of 0.963 (95% CI, 0.939-1.000) for loss of insight. The importance of any single EEG feature was higher than 5% for prediction of 7 symptoms, with the most important EEG features being the absolute delta band power at the occipital electrode sites (O1, 18.8%; Oz, 6.7%) for loss of insight. Over and above the use of baseline symptom scores alone, the use of both EEG and baseline symptom features was associated with a significant increase in the C index for improvement in 4 symptoms: loss of insight (C index increase, 0.012 [95% CI, 0.001-0.020]), energy loss (C index increase, 0.035 [95% CI, 0.011-0.059]), appetite changes (C index increase, 0.017 [95% CI, 0.003-0.030]), and psychomotor retardation (C index increase, 0.020 [95% CI, 0.008-0.032]). Conclusions and Relevance This study suggests that machine learning may be used to identify independent associations of symptoms and EEG features to predict antidepressant-associated improvements in specific symptoms of depression. The approach should next be prospectively validated in clinical trials and settings. Trial Registration ClinicalTrials.gov Identifier: NCT00693849.",2020,"The importance of any single EEG feature was higher than 5% for prediction of 7 symptoms, with the most important EEG features being the absolute delta band power at the occipital electrode sites (O1, 18.8%; Oz, 6.7%) for loss of insight.","['20 sites spanning 5 countries and including 518 adult outpatients (18-65 years of age) from primary care or specialty care practices who received a diagnosis of current major depressive disorder between December 1, 2008, and September 30, 2013', 'Exposures\n\n\nParticipants with major depressive disorder', '518 patients (274 women; mean [SD] age, 39.0 [12.6] years', 'Patients were antidepressant medication naive or willing to undergo a 1-week washout period of any nonprotocol antidepressant medication', 'Adults With Depression']","['escitalopram oxalate', 'sertraline hydrochloride (n\u2009=\u2009176), or extended-release venlafaxine hydrochloride', 'Machine Learning Model']","['appetite changes (C index increase', 'energy loss (C index increase', 'mean [SD] 21-item Hamilton Rating Scale for Depression score', 'C index scores', 'psychomotor retardation', '21-item Hamilton Rating Scale for Depression', 'individual symptoms', 'C index']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}, {'cui': 'C0600526', 'cui_str': 'Sertraline hydrochloride'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0771200', 'cui_str': 'Venlafaxine hydrochloride'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",518.0,0.0823125,"The importance of any single EEG feature was higher than 5% for prediction of 7 symptoms, with the most important EEG features being the absolute delta band power at the occipital electrode sites (O1, 18.8%; Oz, 6.7%) for loss of insight.","[{'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Rajpurkar', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Dass', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Vinjai', 'Initials': 'V', 'LastName': 'Vale', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Arielle S', 'Initials': 'AS', 'LastName': 'Keller', 'Affiliation': 'Stanford Center for Precision Mental Health and Wellness, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Irvin', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Taylor', 'Affiliation': 'Stanford Center for Precision Mental Health and Wellness, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Center for Primary Care, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Stanford Center for Precision Mental Health and Wellness, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6653'] 2028,32568400,Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia and Sleep Apnea Among Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters: A Randomized Clinical Trial.,"Importance There are no established measures to prevent nocturnal breathing disturbances and other altitude-related adverse health effects (ARAHEs) among lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude. Objective To evaluate whether nocturnal oxygen therapy (NOT) prevents nocturnal hypoxemia and breathing disturbances during the first night of a stay at 2048 m and reduces the incidence of ARAHEs. Design, Setting, and Participants This randomized, placebo-controlled crossover trial was performed from January to October 2014 with 32 patients with COPD living below 800 m with forced expiratory volume in the first second of expiration (FEV1) between 30% and 80% predicted, pulse oximetry of at least 92%, not requiring oxygen therapy, and without history of sleep apnea. Evaluations were performed at the University Hospital Zurich (490 m, baseline) and during 2 stays of 2 days and nights each in a Swiss Alpine hotel at 2048 m while NOT or placebo treatment was administered in a randomized order. Between altitude sojourns, patients spent at least 2 weeks below 800 m. Data analysis was performed from January 1, 2015, to December 31, 2018. Intervention During nights at 2048 m, NOT or placebo (room air) was administered at 3 L/min by nasal cannula. Main Outcomes and Measures Coprimary outcomes were differences between NOT and placebo intervention in altitude-induced change in mean nocturnal oxygen saturation (SpO2) as measured by pulse oximetry and apnea-hypopnea index (AHI) measured by polysomnography during night 1 at 2048 m and analyzed according to the intention-to-treat principle. Further outcomes were the incidence of predefined ARAHE, other variables from polysomnography results and respiratory sleep studies in the 2 nights at 2048 m, clinical findings, and symptoms. Results Of the 32 patients included, 17 (53%) were women, with a mean (SD) age of 65.6 (5.6) years and a mean (SD) FEV1 of 53.1% (13.2%) predicted. At 490 m, mean (SD) SpO2 was 92% (2%) and mean (SD) AHI was 21.6/h (22.2/h). At 2048 m with placebo, mean (SD) SpO2 was 86% (3%) and mean (SD) AHI was 34.9/h (20.7/h) (P < .001 for both comparisons). Compared with placebo, NOT increased SpO2 by a mean of 9 percentage points (95% CI, 8-11 percentage points; P < .001), decreased AHI by 19.7/h (95% CI, 11.4/h-27.9/h; P < .001), and improved subjective sleep quality measured on a visual analog scale by 9 percentage points (95% CI, 0-17 percentage points; P = .04). During visits to 2048 m or within 24 hours after descent, 8 patients (26%) using placebo and 1 (4%) using NOT experienced ARAHEs (P < .001). Conclusions and Relevance Lowlanders with COPD experienced hypoxemia, sleep apnea, and impaired well-being when staying at 2048 m. Because NOT significantly mitigated these undesirable effects, patients with moderate to severe COPD may benefit from preventive NOT during high altitude travel. Trial Registration ClinicalTrials.gov Identifier: NCT02150590.",2020,"Compared with placebo, NOT increased SpO2 by a mean of 9 percentage points (95% CI, 8-11 percentage points; P < .001), decreased AHI by 19.7/h (95% CI, 11.4/h-27.9/h; P < .001), and improved subjective sleep quality measured on a visual analog scale by 9 percentage points (95% CI, 0-17 percentage points; P = .04).","['lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude', 'January to October 2014 with 32 patients with COPD living below 800 m with forced expiratory volume in the first second of expiration (FEV1) between 30% and 80% predicted, pulse oximetry of at least 92%, not requiring oxygen therapy, and without history of sleep apnea', '32 patients included, 17 (53%) were women, with a mean (SD) age of 65.6 (5.6) years and a mean (SD) FEV1 of 53.1% (13.2%) predicted', 'Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters']","['NOT or placebo', 'Swiss Alpine hotel at 2048 m while NOT or placebo', 'nocturnal oxygen therapy (NOT', 'Nocturnal Oxygen Therapy', 'placebo']","['subjective sleep quality', 'incidence of predefined ARAHE, other variables from polysomnography results and respiratory sleep studies', 'SpO2', 'visual analog scale', 'altitude-induced change in mean nocturnal oxygen saturation (SpO2) as measured by pulse oximetry and apnea-hypopnea index (AHI', 'hypoxemia, sleep apnea', 'nocturnal hypoxemia and breathing disturbances', 'mean (SD) SpO2', 'decreased AHI', 'nocturnal breathing disturbances', 'Nocturnal Hypoxemia and Sleep Apnea']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0442514', 'cui_str': 'Hotel'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",32.0,0.299445,"Compared with placebo, NOT increased SpO2 by a mean of 9 percentage points (95% CI, 8-11 percentage points; P < .001), decreased AHI by 19.7/h (95% CI, 11.4/h-27.9/h; P < .001), and improved subjective sleep quality measured on a visual analog scale by 9 percentage points (95% CI, 0-17 percentage points; P = .04).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tsogyal D', 'Initials': 'TD', 'LastName': 'Latshang', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sayaka S', 'Initials': 'SS', 'LastName': 'Aeschbacher', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Huber', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Flueck', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Hasler', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philipp M', 'Initials': 'PM', 'LastName': 'Scheiwiller', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Furian', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7940'] 2029,32568464,Effects of Empagliflozin Treatment on Glycerol-Derived Hepatic Gluconeogenesis in Adults with Obesity: A Randomized Clinical Trial.,"OBJECTIVE The aim of this study was to determine the effects of empagliflozin on glycerol-derived hepatic gluconeogenesis in adults with obesity without type 2 diabetes mellitus (T2DM) using oral carbon 13 ( 13 C)-labeled glycerol. METHODS A randomized, double-blind, placebo-controlled trial was performed in participants with magnetic resonance imaging assessment of body fat and measurement of glycerol-derived 13 C enrichment in plasma glucose by nuclear magnetic resonance spectroscopy following ingestion of [U- 13 C 3 ]glycerol. Participants were randomized to oral empagliflozin 10 mg once daily or placebo for 3 months. Glycerol-derived 13 C enrichment studies were repeated, and treatment differences in the mean percentage of 13 C glycerol enrichment in glucose were compared using mixed linear models. RESULTS Thirty-five participants completed the study. Empagliflozin increased glycerol-derived 13 C enrichment between baseline and follow-up by 6.5% (P = 0.005), consistent with less glycerol from visceral adipose tissue (VAT). No difference was found with placebo. Glycerol-derived 13 C enrichment was lower in participants with high VAT compared with low VAT by 12.6% (P = 0.04), but there was no heterogeneity of the treatment effect by baseline VAT. Glycerol-derived 13 C enrichment was inversely correlated with VAT but was not correlated with weight loss. CONCLUSIONS VAT is associated with endogenous glycerol-derived hepatic gluconeogenesis, and empagliflozin reduces endogenous glycerol gluconeogenesis in adults with obesity without T2DM. These findings suggest a mechanism by which sodium-glucose cotransporter 2 inhibitors may prevent T2DM in obesity.",2020,"Empagliflozin increased glycerol-derived 13 C enrichment between baseline and follow-up by 6.5% (P = 0.005), consistent with less glycerol from visceral adipose tissue (VAT).","['Adults with Obesity', 'adults with obesity without type 2 diabetes mellitus (T2DM) using oral carbon 13 ( 13 C)-labeled glycerol', 'Thirty-five participants completed the study', 'adults with obesity without T2DM', 'participants with magnetic resonance imaging assessment of body fat and measurement of']","['empagliflozin', 'glycerol-derived 13 C enrichment in plasma glucose by nuclear magnetic resonance spectroscopy following ingestion of [U- 13 C 3 ]glycerol', 'glycerol-derived hepatic gluconeogenesis', 'oral empagliflozin 10 mg once daily or placebo', 'Empagliflozin', 'placebo']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0017715', 'cui_str': 'Gluconeogenesis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",35.0,0.48677,"Empagliflozin increased glycerol-derived 13 C enrichment between baseline and follow-up by 6.5% (P = 0.005), consistent with less glycerol from visceral adipose tissue (VAT).","[{'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'Division of Cardiology, University of Texas Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'de Albuquerque Rocha', 'Affiliation': 'Division of Cardiology, University of Texas Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Division of Cardiology, University of Texas Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Colby R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': 'Division of Cardiology, University of Texas Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Malloy', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Eunsook S', 'Initials': 'ES', 'LastName': 'Jin', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Center, Dallas, Texas, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22854'] 2030,32568470,Coronal Bacterial Penetration after 7 days in class II endodontic access cavities restored with two temporary restorations: A Randomised Clinical Trial.,"The aim of this in vivo randomised clinical trial was to assess coronal bacterial penetration after placement of Cavit G and IRM temporary restorations in class II endodontic access cavities. After completion of endodontic treatment, placement of an orifice seal and disinfection of the operating field, sterile cotton pellets were placed in the pulp chamber and the cavities were restored with Cavit G or IRM. After 7 days, coronal and proximal restoration thickness was measured by digital radiographs. Cotton pellet was evaluated by culture methods and polymerase chain reaction assay and bacterial species identified. Bacterial growth was observed in 5 of the 27 (18%) Cavit G samples and in 11 of the 27 (40%) IRM samples which was not significant. Coronal restoration thickness of 4-5 mm and proximal restoration thickness of more than 2.15 mm for Cavit G and 2.35 mm for IRM are recommended to prevent bacterial penetration over 7 days. Adequate restoration thickness is critical to prevent bacterial penetration.",2020,Bacterial growth was observed in 5 of the 27 (18%) Cavit G samples and in 11 of the 27 (40%),['class II endodontic access cavities'],['Cavit G and IRM temporary restorations'],"['Bacterial growth', 'coronal bacterial penetration', 'coronal and proximal restoration thickness', 'Coronal restoration thickness', 'Coronal Bacterial Penetration']","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0054898', 'cui_str': 'Cavit G'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.143247,Bacterial growth was observed in 5 of the 27 (18%) Cavit G samples and in 11 of the 27 (40%),"[{'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Shanmugam', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Angambakkam Rajasekaran', 'Initials': 'AR', 'LastName': 'PradeepKumar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Paul Vincent', 'Initials': 'PV', 'LastName': 'Abbott', 'Affiliation': 'UWA Dental School, The University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Periasamy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Gopikrishna', 'Initials': 'G', 'LastName': 'Velayutham', 'Affiliation': 'Dept of Conservative Dentistry & Endodontics, Sri Ramachandra Institute of Higher Education & Reasearch, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Mahalakshmi', 'Affiliation': 'Department of Microbiology, Sree Balaji Dental College and Hospital, Pallikaranai, Chennai, Tamil Nadu, India.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12415'] 2031,32563378,"Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.","BACKGROUND Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. METHODS We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. FINDINGS Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). INTERPRETATION We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial. FUNDING UK National Institute for Health Research Health Technology Assessment Programme.",2020,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"['patients with gastrointestinal bleeding', 'Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding', 'patients with trauma', '164 hospitals in 15 countries', 'patients with acute gastrointestinal bleeding (HALT-IT', 'Between July 4, 2013, and June 21, 2019, we randomly allocated 12\u2008009 patients to receive']","['Tranexamic acid', 'placebo', 'matching placebo', 'tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9', 'tranexamic acid', '0·9% sodium chloride']","['death due to bleeding', 'death and thromboembolic events', 'Venous thromboembolic events (deep vein thrombosis or pulmonary embolism', 'Arterial thromboembolic events (myocardial infarction or stroke', 'Death due to bleeding', 'death from gastrointestinal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0024050', 'cui_str': 'Lower gastrointestinal hemorrhage'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0266807', 'cui_str': 'Acute gastrointestinal hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0104485', 'cui_str': 'AT 125'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",12009.0,0.734066,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30848-5'] 2032,32563539,"Quantification of changes in eyelid position in patients with dry eye syndrome: A randomized, placebo-controlled multicenter study of application of topical anesthetic.","PURPOSE To quantify and compare baseline eyelid positions in patients with dry eye syndrome (DES) to controls and to determine the effect of topical anesthetic administration on these parameters. METHODS Two-center, double-masked, placebo-controlled randomized trial. In a masked fashion, each patient had topical placebo administered in one eye and topical anesthetic in the fellow eye. Upper eyelid marginal reflex distance (MRD1) and lower eyelid marginal reflex distance (MRD2) were recorded at baseline and 5 min after drop administration. Fluorescein was instilled in each eye, and the patient's surface dryness was assessed using the National Eye Institute (NEI) grading system. Individuals were then categorized as DES patients (NEI score ≥4) or control patients. The primary measures included MRD1 and palpebral fissure (PF) height. RESULTS Mean MRD1 at baseline was 3.86 mm (SD±0.89) in DES patients and 3.94 mm (SD±0.88) in control patients (P = 0.71). Control patients showed an increase in average MRD1 after anesthetic exposure (3.93 mm pre-exposure, 4.18 mm post-exposure, P = 0.0141), compared to DES patients, who displayed no change in MRD1 after topical anesthetic administration (3.91 mm pre and post-exposure, P = 0.0446). The increase in post-anesthetic palpebral fissure height in the control group, when compared to the observed baseline, was also statistically significant (8.40 mm pre-exposure, 8.73 mm post-exposure, P = 0.015). CONCLUSIONS Non-DES patients exhibited a statistically significant increase in MRD1 after topical anesthetic application, while this effect was not seen in patients with DES. A trend towards increased baseline (pre-intervention) upper eyelid position in control patients was observed when compared to DES patients.",2020,A trend towards increased baseline (pre-intervention) upper eyelid position in control patients was observed when compared to DES patients.,"['patients with dry eye syndrome', 'patients with dry eye syndrome (DES', 'patients with DES']","['topical anesthetic', 'topical placebo', 'Fluorescein', 'placebo']","['post-anesthetic palpebral fissure height', 'Mean MRD1', 'MRD1', 'MRD1 and palpebral fissure (PF) height', 'Upper eyelid marginal reflex distance (MRD1) and lower eyelid marginal reflex distance (MRD2', 'average MRD1 after anesthetic exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0423104', 'cui_str': 'Height of palpebral fissure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1969562', 'cui_str': 'Mental Retardation, Autosomal Dominant 1'}, {'cui': 'C0229244', 'cui_str': 'Structure of palpebral fissure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1828341', 'cui_str': 'Upper eyelid margin reflex distance'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C1827217', 'cui_str': 'Margin reflex distance'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.47251,A trend towards increased baseline (pre-intervention) upper eyelid position in control patients was observed when compared to DES patients.,"[{'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Greenberg', 'Affiliation': 'Department of Ophthalmology, Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Division of Ophthalmology, Cook County Health and Hospital Systems, Chicago, IL, USA.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Phelps', 'Affiliation': 'Division of Ophthalmology, NorthShore University HealthSystem, Evanston, IL, USA; Department of Ophthalmology and Visual Science, University of Chicago, Chicago, IL, USA. Electronic address: PPhelps@northshore.org.'}]",Disease-a-month : DM,['10.1016/j.disamonth.2020.101026'] 2033,32562103,Barbershop Management of Hypertension in the African American Population: Pitfalls and Opportunities for Extension to Other Underserved Communities.,"PURPOSE OF REVIEW This review summarizes the results of recent barbershop-based studies focusing on the diagnosis and management of hypertension (HTN) in black adults. The pitfalls of prior attempts and opportunities for the development of future programs to address health disparities on a larger scale are also reviewed. RECENT FINDINGS While barbershop health outreach has become a commonplace in recent years, the quality of the evidence on the effectiveness of such programs has been weak, until the Los Angeles Barbershop Blood Pressure Study (LABBPS), a rigorously carried out cluster-randomized trial, demonstrated a - 21 mmHg greater reduction in BP among black hypertensive men who were assigned to a pharmacist-led HTN intervention when compared with usual care. Given the available evidence, barber health promotion paired with focused hypertension-specialty care has the potential to reduce, if not eliminate, the present wide gap in hypertension care and ultimately lead to a reduction of hypertension-related complications among blacks. Future research should seek to improve the scalability and transferability of the LABBPS model both to other geographic regions and to other at-risk groups.",2020,Future research should seek to improve the scalability and transferability of the LABBPS model both to other geographic regions and to other at-risk groups.,"['black hypertensive men', 'black adults']",['pharmacist-led HTN intervention'],[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0162602,Future research should seek to improve the scalability and transferability of the LABBPS model both to other geographic regions and to other at-risk groups.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ebinger', 'Affiliation': 'Cedars-Sinai Medical Center, Smidt Heart Institute, 127 S. San Vicente Blvd., Ste. A3600, Los Angeles, CA, 90048, USA. Joseph.Ebinger@csmc.edu.'}, {'ForeName': 'Ciantel A', 'Initials': 'CA', 'LastName': 'Blyler', 'Affiliation': 'Cedars-Sinai Medical Center, Smidt Heart Institute, 127 S. San Vicente Blvd., Ste. A3600, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Brettler', 'Affiliation': 'Kaiser-Permanente, Los Angeles, CA, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rader', 'Affiliation': 'Cedars-Sinai Medical Center, Smidt Heart Institute, 127 S. San Vicente Blvd., Ste. A3600, Los Angeles, CA, 90048, USA.'}]",Current cardiology reports,['10.1007/s11886-020-01319-9'] 2034,32562395,Effect of Rehydration With Normal Saline Versus Ringer Lactate on Serum Sodium Level of Children With Acute Diarrhea and Severe Dehydration: A Randomized Controlled Trial.,"OBJECTIVE To demonstrate the equivalence of Normal Saline (NS) and Ringer Lactate (RL) for change in serum sodium levels during correction of severe dehydration in children with acute diarrhea based on World Health Organization (WHO) plan C. DESIGN Equivalence randomized control trial. SETTING Pediatric diarrhea unit of a tertiary care hospital from May, 2016 to April, 2017. PARTICIPANTS 72 children of 1-12 years with acute diarrhea and severe dehydration were enrolled. Children with dysentery, severe acute malnutrition, severe anemia, meningitis, and known surgical and systemic diseases were excluded. INTERVENTION RL (n=36) or NS (n=36) were used as per WHO plan C. Blood samples were drawn before intravenous fluid correction and 3 h post-intervention. OUTCOME MEASURES Mean change in serum sodium level from the baseline between the RL and NS groups. RESULTS 70 children (35 in each group) completed the study. The difference in mean serum sodium levels from baseline in RL and NS groups were 1.4 (4.5) mEq/L and 2.1(4.9) mEq/L, respectively (P=0.58). CONCLUSION Both RL and NS are equivalent in terms of change in serum sodium from baseline for intravenous rehydration in children with acute diarrhea and severe dehydration.",2020,Both RL and NS are equivalent in terms of change in serum sodium from baseline for intravenous rehydration in children with acute diarrhea and severe dehydration.,"['Pediatric diarrhea unit of a tertiary care hospital from May, 2016 to April, 2017', 'Children With Acute Diarrhea and Severe Dehydration', 'children with acute diarrhea based on World Health Organization (WHO) plan C', '70 children (35 in each group) completed the study', 'children with acute diarrhea and severe dehydration', '72 children of 1-12 years with acute diarrhea and severe dehydration were enrolled', 'Children with dysentery, severe acute malnutrition, severe anemia, meningitis, and known surgical and systemic diseases were excluded']","['Normal Saline (NS) and Ringer Lactate (RL', 'Rehydration With Normal Saline Versus Ringer Lactate']","['Serum Sodium Level', 'Mean change in serum sodium level', 'mean serum sodium levels']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C3472181', 'cui_str': 'Severe dehydration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013369', 'cui_str': 'Infectious diarrheal disease'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}]","[{'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",70.0,0.186479,Both RL and NS are equivalent in terms of change in serum sodium from baseline for intravenous rehydration in children with acute diarrhea and severe dehydration.,"[{'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Dubey', 'Affiliation': 'Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Mishra', 'Affiliation': 'Department of Biochemistry, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Raghvendra', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India. Correspondence to: Dr Raghvendra Singh, Associate Professor, Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India. drraghvendrasingh@gmail.com.'}]",Indian pediatrics,[] 2035,32562440,Evaluation and improvement of blood donor educational materials: results from a multicenter randomized controlled trial.,"BACKGROUND Blood collection centers are charged with creating donor educational materials (DnEM) that are easily understood across all prospective donor populations, while addressing mandates and recommendations from regulatory agencies and professional standard setting organizations. Donors must have sufficient information to understand the donation process with its risks and benefits, time to consider options before deciding, and opportunity to choose whether to proceed with or decline donating. The goal of this multisite randomized controlled trial was to evaluate knowledge acquired using standardized DnEM. America's Blood Centers' Working Group (WG) for Donor Education and Communication was formed to evaluate and suggest modifications of these documents. Based on pilot work, a randomized clinical trial was designed to test donor knowledge across a variety of populations. The WG identified several shortcomings in the current DnEM and proposed new DnEM. The new DnEM were tested against the same, current DnEM being used at all three sites (Blood Donor Educational Material, 2016 version 2.0, published in conjunction with the AABB uniform donor history questionnaire). METHODS AND MATERIALS One-hundred sixty-five first time and returning donors were randomized in a 2x2 model to review either new DnEM or current DnEM. Every participant completed a pre- and post-quiz that tested their understanding of the DnEM. RESULTS Returning donors had greater baseline knowledge compared to new donors, but new donors improved more versus returning donors. Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM. CONCLUSION Comprehension of DnEM can be improved. With this sample size the results suggest that the findings are independent of demographic characteristics, but a larger study would be necessary to confirm this.",2020,"Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM. ",['One-hundred sixty-five first time and returning donors'],['new DnEM or current DnEM'],['blood donor educational materials'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",,0.0582905,"Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM. ","[{'ForeName': 'Gay', 'Initials': 'G', 'LastName': 'Wehrli', 'Affiliation': 'University of Virginia Health, Charlottesville, Virginia, USA.'}, {'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Rossmann', 'Affiliation': 'Gulf Coast Regional Blood Center, Houston, Texas, USA.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Waxman', 'Affiliation': 'Versiti, Indianapolis, Indiana, USA.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Katz', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa, USA.'}]",Transfusion,['10.1111/trf.15866'] 2036,32562632,Long-term developmental effect of withholding parenteral nutrition in paediatric intensive care units: a 4-year follow-up of the PEPaNIC randomised controlled trial.,"BACKGROUND The PEPaNIC randomised controlled trial, which recruited 1440 critically ill infants and children in 2012-15, showed that withholding parenteral nutrition for 1 week (late-parenteral nutrition), compared with early supplementation within 24 h of admission to the paediatric intensive care unit (early-parenteral nutrition), prevented infections, accelerated recovery, and improved neurocognitive development assessed 2 years later. Because several neurocognitive domains can only be thoroughly assessed from age 4 years onwards, we aimed to determine the effect of late-parenteral nutrition versus early-parenteral nutrition on physical, neurocognitive, and emotional and behavioural development 4 years after randomisation. METHODS This is a preplanned, blinded, 4-year follow-up study of participants included in the PEPaNIC trial (done at University Hospitals Leuven, Belgium; Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) and of matched healthy children. Studied outcomes were anthropometrics; health status; parent-reported or caregiver-reported executive functions, and emotional and behavioural problems; and clinical tests for intelligence, visual-motor integration, alertness, motor coordination, and memory. Through multivariable linear and logistic regression analyses, after imputation for missing values (≤30%) and adjustment for risk factors, we investigated the effect of early-parenteral nutrition versus late-parenteral nutrition. This trial is registered with ClinicalTrials.gov, NCT01536275. FINDINGS Between March 8, 2016, and Nov 8, 2019, 684 children from the original PEPaNIC trial (356 from the late-parenteral nutrition group and 328 from the early-parenteral nutrition group) were assessed for neurocognitive development at 4-years follow-up. Compared with the control group (369 healthy children), children who had critical illness had lower height (β-estimate -2·11 [95% CI -3·15 to -1·06]; p<0·0001) and head circumference (-0·42 [-0·67 to -0·18]; p=0.00077); and worse health status (eg, hospital admission odds ratio 4·27 [95% CI 3·12 to 5·84]; p<0·0001), neurocognitive (eg, parent-reported or caregiver-reported total executive functioning β-estimate 3·57 [95% CI 1·95 to 5·18], p<0·0001; total intelligence quotient -7·35 [-9·31 to -5·39], p<0·0001), and parent-reported or caregiver-reported emotional and behavioural developmental outcomes (internalising 2·73 [1·19 to 4·28], p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors. Outcomes were never worse in the late-parenteral nutrition group compared with the early-parenteral nutrition group, but patients in the late-parenteral nutrition group had fewer parent-reported or caregiver-reported internalising (β-estimate -1·88 [95% CI -3·69 to -0·07]; p=0·042), externalising (-1·73 [-3·43 to -0·03]; p=0·046), and total emotional and behavioural problems (-2·44 [-4·22 to -0·67]; p=0·0070) than patients who had received early-parenteral nutrition, after adjusting for risk factors, and were no longer different from healthy controls for these outcomes. INTERPRETATION Omitting early parenteral nutrition use for critically ill children did not adversely affect long-term outcomes 4 years after randomisation and protected against emotional and behavioural problems, further supporting the deimplementation of early parenteral nutrition. FUNDING European Research Council, Methusalem, Flanders Institute for Science and Technology, Research Foundation Flanders, Sophia Foundation, Stichting Agis Zorginnovatie, Erasmus Trustfonds, and the European Society for Clinical Nutrition and Metabolism.",2020,"p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors.","['Between March 8, 2016, and Nov 8, 2019, 684 children from the original PEPaNIC trial (356 from the late-parenteral nutrition group and 328 from the early-parenteral nutrition group', '369 healthy children), children who had critical illness had lower height (β-estimate -2·11', 'paediatric intensive care units', ""participants included in the PEPaNIC trial (done at University Hospitals Leuven, Belgium; Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) and of matched healthy children"", '1440 critically ill infants and children in 2012-15, showed that withholding parenteral nutrition for 1 week (late-parenteral nutrition), compared with early supplementation within 24 h of admission to the paediatric intensive care unit (early-parenteral nutrition), prevented infections, accelerated recovery, and improved neurocognitive development assessed 2 years later']","['4·22 to -0·67', '7·35', 'withholding parenteral nutrition']","['neurocognitive development', 'neurocognitive (eg, parent-reported or caregiver-reported total executive functioning β-estimate 3·57', 'anthropometrics; health status; parent-reported or caregiver-reported executive functions, and emotional and behavioural problems; and clinical tests for intelligence, visual-motor integration, alertness, motor coordination, and memory', 'total emotional and behavioural problems (-2·44', 'total intelligence quotient', 'worse health status (eg, hospital admission odds ratio 4·27', 'head circumference (-0·42 [-0·67 to -0·18']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517576', 'cui_str': '1440'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",684.0,0.251002,"p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors.","[{'ForeName': 'An', 'Initials': 'A', 'LastName': 'Jacobs', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Karolijn', 'Initials': 'K', 'LastName': 'Dulfer', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Renate D', 'Initials': 'RD', 'LastName': 'Eveleens', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Hordijk', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Van Cleemput', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Verlinden', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Liese', 'Initials': 'L', 'LastName': 'Mebis', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Gonzalo Garcia', 'Initials': 'GG', 'LastName': 'Guerra', 'Affiliation': ""Department of Paediatrics, Intensive Care Unit, University of Alberta, Stollery Children's Hospital, Edmonton, Canada.""}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Joosten', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Sascha C', 'Initials': 'SC', 'LastName': 'Verbruggen', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Güiza', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium. Electronic address: greet.vandenberghe@kuleuven.be.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30104-8'] 2037,32562650,"Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis.","BACKGROUND Trials of intermittent preventive treatment (IPTp) of malaria in pregnant women that compared dihydroartemisinin-piperaquine with the standard of care, sulfadoxine-pyrimethamine, showed dihydroartemisinin-piperaquine was superior at preventing malaria infection, but not at improving birthweight. We aimed to assess whether sulfadoxine-pyrimethamine shows greater non-malarial benefits for birth outcomes than does dihydroartemisinin-piperaquine, and whether dihydroartemisinin-piperaquine shows greater antimalarial benefits for birth outcomes than does sulfadoxine-pyrimethamine. METHODS We defined treatment as random assignment to sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine before pooling individual participant-level data from 1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811). We quantified the relative effect of treatment on birthweight (primary outcome) attributed to preventing placental malaria infection (mediator). We estimated antimalarial (indirect) and non-malarial (direct) effects of IPTp on birth outcomes using causal mediation analyses, accounting for confounders. We used two-stage individual participant data meta-analyses to calculate pooled-effect sizes. FINDINGS Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69 g, 95% CI 26 to 112), despite placental malaria infection being lower in the dihydroartemisinin-piperaquine group (relative risk [RR] 0·64, 95% CI 0·39 to 1·04). Mediation analyses showed sulfadoxine-pyrimethamine conferred a greater non-malarial effect than did dihydroartemisinin-piperaquine (mean difference 87 g, 95% CI 43 to 131), whereas dihydroartemisinin-piperaquine conferred a slightly larger antimalarial effect than did sulfadoxine-pyrimethamine (8 g, -9 to 26), although more frequent dosing increased the antimalarial effect (31 g, 3 to 60). INTERPRETATION IPTp with sulfadoxine-pyrimethamine appears to have potent non-malarial effects on birthweight. Further research is needed to evaluate monthly dihydroartemisinin-piperaquine with sulfadoxine-pyrimethamine (or another compound with non-malarial effects) to achieve greater protection against malarial and non-malarial causes of low birthweight. FUNDING Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bill & Melinda Gates Foundation, and Worldwide Antimalarial Resistance Network.",2020,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","['pregnant women that compared dihydroartemisinin-piperaquine with the standard of care', '1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811']","['sulfadoxine-pyrimethamine', 'sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine', 'IPTp']","['placental malaria infection (mediator', 'antimalarial effect', 'Overall, birthweight', 'placental malaria infection']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",1617.0,0.206058,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","[{'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Roh', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA. Electronic address: michelle.roh@ucsf.edu.'}, {'ForeName': 'Feiko O Ter', 'Initials': 'FOT', 'LastName': 'Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Rerolle', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'M Maria', 'Initials': 'MM', 'LastName': 'Glymour', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Shiboski', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Ianziva"", 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Chico', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30119-4'] 2038,32562670,Extended short-term follow-up for a trial of treatment of unruptured arteriovenous malformations.,,2020,,[],[],[],[],[],[],,0.0181838,,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK. Electronic address: peter.rothwell@ndcn.ox.ac.uk.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30178-2'] 2039,32562747,Effects of an 8-week resistance training intervention on plantar flexor muscle quality and functional capacity in older women: A randomised controlled trial.,"The present study examined 8 weeks of resistance training and its effects on muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity in older women. Moreover, we tested if changes in muscle quality were associated with functional capacity. Twenty-four older women (66.3 ± 5.8 years; 69.0 ± 3.0 kg; 25.3 ± 1.4 kg·m -2 ) were recruited to the study. After completion of the baseline assessment, participants were randomly assigned to either the resistance training (RET, n = 12) or an active control group (CTR, n = 12). Muscle quality was evaluated through muscle echo intensity (MQ EI ) and specific tension (MQ ST ). Muscle thickness, unilateral plantar flexor muscle strength and functional tests were evaluated at baseline and after the training period. After 8 weeks, both MQ EI and MQ ST did not respond to the intervention. Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05). Finally, significant gains in muscle hypertrophy were observed in the RET group (P < 0.01), while muscle strength failed to change significantly (P > 0.05). In conclusion, a resistance training program provided significant benefits in the stair climb test, unrelated to plantar flexor-derived muscle quality measures as previously demonstrated in quadriceps femoris.",2020,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","['older women', 'Twenty-four older women (66.3\u202f±\u202f5.8\u202fyears; 69.0\u202f±\u202f3.0\u202fkg; 25.3\u202f±\u202f1.4\u202fkg·m -2 ']","['8-week resistance training intervention', 'resistance training (RET, n\u202f=\u202f12) or an active control', 'resistance training']","['stair climb performance', 'Muscle quality', 'plantar flexor-derived muscle quality', 'muscle quality', 'plantar flexor muscle quality and functional capacity', 'Muscle thickness, unilateral plantar flexor muscle strength and functional tests', 'muscle hypertrophy', 'muscle strength', 'muscle echo intensity (MQ EI ) and specific tension (MQ ST ', 'muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.0161992,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia. Electronic address: p.lopezda@our.ecu.edu.au.'}, {'ForeName': 'Brendan James', 'Initials': 'BJ', 'LastName': 'Crosby', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Bruna Patrícia', 'Initials': 'BP', 'LastName': 'Robetti', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Douglas Jean Preussler', 'Initials': 'DJP', 'LastName': 'Turella', 'Affiliation': 'Centro Clínico UCS, Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Thaís Andréia Schepa', 'Initials': 'TAS', 'LastName': 'Weber', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Morgana Lima', 'Initials': 'ML', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111003'] 2040,32562807,Minimising COVID-19 exposure during tracheal intubation by using a transparent plastic box: A randomised prospective simulation study.,,2020,,[],[],[],[],[],[],,0.0231458,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clariot', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France. Electronic address: simon.clariot@aphp.fr.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Dumain', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gauci', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Langeron', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France; Experimental Neuropathology Unit, Institut Pasteur, 75015 Paris, France.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Levesque', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France; EA DYNAMYC Université Paris-Est Créteil (UPEC), École Nationale Vétérinaire d'Alfort (ENVA), Faculté de Santé de Créteil, 8, rue du Général Sarrail, 94010 Créteil, France.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.06.005'] 2041,32563116,Screening and brief intervention for lower-risk drug use in primary care: A pilot randomized trial.,"AIMS The efficacy of screening and brief intervention for lower-risk drug use is unknown. This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening. METHODS We randomly assigned participants identified by screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV). Primary outcome was number of days use of main drug in the past 30 as determined by validated calendar method at 6 months. Analyses were performed using negative binomial regression adjusted for baseline use and main drug. RESULTS Of 142 eligible adults, 61(43 %) consented and were randomized. Participant characteristics were: mean age 41; 54 % male; 77 % black. Main drug was cannabis 70 %, cocaine 15 %, prescription opioid 10 %; 7% reported injection drug use and mean days use of main drug (of 30) was 3.4. At 6 months, 93 % completed follow-up and adjusted mean days use of main drug were 6.4 (no BI) vs 2.1 (BNI) (incidence rate ratio, IRR 0.33[0.15-0.74]) and 2.3 (MOTIV) (IRR 0.36[0.15-0.85]). CONCLUSIONS BI appears to have efficacy for preventing an increase in drug use in primary care patients with lower-risk use identified by screening. These findings raise the potential that less severe patterns of drug use in primary care may be uniquely amenable to brief intervention and warrant replication.",2020,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening. ","['Of 142 eligible adults, 61(43 %) consented and were randomized', 'Participant characteristics were: mean age 41; 54 % male; 77 % black', 'lower-risk drug use in primary care', 'primary care patients with lower-risk drug use identified by screening', 'primary care patients with lower-risk use identified by screening']","['brief interventions (BIs', 'screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV', 'screening and brief intervention']",['number of days use of main drug in the past 30 as determined by validated calendar method'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0035513', 'cui_str': 'Contraceptive rhythm method'}]",142.0,0.0558587,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening. ","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bertholet', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and University of Lausanne, Bugnon 23A, Lausanne, 1011, Switzerland. Electronic address: Nicolas.Bertholet@chuv.ch.'}, {'ForeName': 'Seville', 'Initials': 'S', 'LastName': 'Meli', 'Affiliation': 'Upstream USA, Cambridge, MA 02140, USA.'}, {'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychology, Boston University, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: palfai@bu.edu.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: dmcheng@bu.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Alford', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: Dan.Alford@bmc.org.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: jbernste@bu.edu.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: jsamet@bu.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lloyd-Travaglini', 'Affiliation': 'Data Coordinating Center, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: clloyd@bu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: rsaitz@bu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108001'] 2042,32563171,Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy.,"PURPOSE This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332. METHODS Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs). RESULTS During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel. CONCLUSION In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.",2020,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","['and myoclonic and absence seizures', 'patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332', 'Patients experiencing myoclonic and/or absence seizures during study baseline were included', 'patients with idiopathic generalized epilepsy', 'IGE patients with myoclonic and/or absence seizures']","['Adjunctive perampanel', 'adjunctive perampanel', 'placebo']","['responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs', 'seizure frequency', 'overall worsening of absence seizures', 'myoclonic and/or absence seizures', 'seizure frequency, number of seizure days and seizure-free days', 'seizure-freedom rates', 'myoclonic and absence seizure outcomes']","[{'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.383148,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.'}]",Seizure,['10.1016/j.seizure.2020.06.011'] 2043,32563173,Impact of childhood adversity on network reconfiguration dynamics during working memory in hypogonadal women.,"Many women with no history of cognitive difficulties experience executive dysfunction during menopause. Significant adversity during childhood negatively impacts executive function into adulthood and may be an indicator of women at risk of a mid-life cognitive decline. Previous studies have indicated that alterations in functional network connectivity underlie these negative effects of childhood adversity. There is growing evidence that functional brain networks are not static during executive tasks; instead, such networks reconfigure over time. Optimal dynamics are necessary for efficient executive function; while too little reconfiguration is insufficient for peak performance, too much reconfiguration (supra-optimal reconfiguration) is also maladaptive and associated with poorer performance. Here we examined the impact of adverse childhood experiences (ACEs) on network flexibility, a measure of dynamic reconfiguration, during a letter n-back task within three networks that support executive function: frontoparietal, salience, and default mode networks. Several animal and human subject studies have suggested that childhood adversity exerts lasting effects on executive function via serotonergic mechanisms. Tryptophan depletion (TD) was used to examine whether serotonin function drives ACE effects on network flexibility. We hypothesized that ACE would be associated with higher flexibility (supra-optimal flexibility) and that TD would further increase this measure. Forty women underwent functional imaging at two time points in this double-blind, placebo controlled, crossover study. Participants also completed the Penn Conditional Exclusion Test, a task assessing abstraction and mental flexibility. The effects of ACE and TD were evaluated using generalized estimating equations. ACE was associated with higher flexibility across networks (frontoparietal β = 0.00748, D = 2.79, p = 0.005; salience β = 0.00679, D = 3.02, p = 0.003; and default mode β = 0.00910, D = 3.53, p = 0.0004). While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D = 2.15, p = 0.03; salience β = 0.00393, D = 1.91, p = 0.06; default mode β = 0.00334, D = 1.73, p = 0.08). These results suggest that childhood adversity has lasting impacts on dynamic reconfiguration of functional brain networks supporting executive function and that decreasing serotonin levels may exacerbate these effects.",2020,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","['Forty women underwent', 'hypogonadal women', 'Many women with no history of cognitive difficulties experience executive dysfunction during menopause']","['ACE', 'Tryptophan depletion (TD', 'functional imaging', 'placebo']","['ACE and TD, active TD increased network flexibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0587112', 'cui_str': 'During menopause'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.0712399,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Shanmugan', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: sheilashanmugan@gmail.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Theodore D', 'Initials': 'TD', 'LastName': 'Satterthwaite', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Ashourvan', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Bassett', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Department of Physics & Astronomy, University of Pennsylvania, Philadelphia, PA, USA; Department of Electrical & Systems Engineering, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kosha', 'Initials': 'K', 'LastName': 'Ruparel', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'C Neill', 'Initials': 'CN', 'LastName': 'Epperson', 'Affiliation': 'Department of Psychiatry, Anschutz Medical Campus, University of Colorado, Aurora, CO USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Loughead', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104710'] 2044,32563179,The effects of the iPlayClean education programme on doping attitudes and susceptibility to use banned substances among high-level adolescent athletes from the UK: A cluster-randomised controlled trial.,"Background This study examined the effects of the iPlayClean anti-doping intervention on attitudes towards doping and susceptibility, and whether delivery mode affected the results. Methods A total of 1081 high-level UK athletes (14-18 years old, 904 males, 177 females) were cluster-randomised to the control (11 teams/organisations/schools, 314 athletes), face-to-face group presentation (8 teams/organisations/schools, 254 athletes), online (11 teams/organisations/schools, 251 athletes), or face-to-face presentation with online access (5 teams/organisations/schools, 262 athletes). Results Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later. All delivery modes impacted doping susceptibility immediately after the intervention, in comparison to the control group, but the effects were only sustained for the face-to-face presentation group. Conclusion Contrary to findings within previous anti-doping interventions, we have shown that doping attitudes can be changed and that the results can be sustained across all modes of delivery, 8 weeks later. Research is required to assess for how long these changes are sustained, and how often anti-doping education should be delivered to high-level athletes to reinforce clean play values.",2020,"Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later.","['1081 high-level UK athletes (14-18 years old, 904 males, 177 females) were cluster-randomised to the control (11 teams/organisations/schools, 314 athletes), face-to-face group presentation (8 teams/organisations/schools, 254 athletes), online (11 teams/organisations/schools, 251 athletes), or face-to-face presentation with online access (5 teams/organisations/schools, 262 athletes', 'high-level adolescent athletes from the UK']","['iPlayClean anti-doping intervention', 'iPlayClean education programme']",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0233269', 'cui_str': 'Face presentation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]",[],1081.0,0.0185148,"Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Nicholls', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK. Electronic address: A.Nicholls@hull.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morley', 'Affiliation': 'Department of Dietetics, Nutrition, and Sport, La Trobe University, Melbourne 3086 VIC, Australia.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Hull York Medical School, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Abt', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Rothwell', 'Affiliation': 'Academy of Sport and Physical Activity, Sheffield Hallam University, Howard St, Sheffield S1 1WB, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cope', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Espinal Way, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-Being Research Group,(,) School of Psychology, Curtin University, Kent St, Bentley, WA 6102, Australia.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102820'] 2045,32566071,Effect of short-course glucocorticoid application on patients with chronic rhinosinusitis with nasal polyps.,"Background Local and systemic glucocorticoids are mainstay therapies for chronic rhinosinusitis. With respect to local glucocorticoids, nasal spray is used extensively, but some patients do not benefit from short-course treatment. Recently, some clinicians have focused on the effects of high-dose local glucocorticoids in chronic rhinosinusitis with nasal polyps (CRSwNP), such as treatment using nasal irrigation, transnasal nebulization, and nose-dripping therapy (nasal drop) with high-dose budesonide. However, there are little data comparing the effect of short-course high-dose local glucocorticoids with regular nasal spray and oral steroids in the treatment of preoperative CRSwNP patients. Furthermore, the appropriate use of different types of glucocorticoids in different endotypes of CRSwNP remains unclear. Methods This randomized controlled clinical research study was performed at a single academic center. Patients who satisfied the criteria of chronic rhinosinusitis with bilateral nasal polyps were randomly assigned in a 1:1:1 ratio to receive oral methylprednisolone, 24 mg/d and budesonide nasal spray, 256 μg/d, or intranasal budesonide suspension, 1 mg/d and budesonide nasal spray, 256 μg/d, or budesonide nasal spray, 256 μg/d for one week. Symptoms, endoscopic scores, and tissue and blood inflammatory cells were recorded before and after the study. Adverse events were recorded by clinicians. Results A total of 127 patients with CRSwNP underwent randomization. The total nasal symptoms scores (TNSS) decreased significantly in all groups compared to those at baseline. The assessment of the reduction in TNSS demonstrated that the change was significantly greater in the nasal drop group than in the nasal spray group (-7.47 vs -4.10, P  = 0.032), and it was also greater in the oral steroid group than in the nasal spray group (-7.30 vs -4.10, P  = 0.039). A similar trend also appeared in the reduction in Sinonasal-Outcome Test 22 (SNOT-22). After treatment, a significantly reduction in NP score was observed in the nasal drop group (-0.82) and oral steroid group (-0.85) compared with that in the nasal spray group (-0.10), and there was no significant difference between the nasal drop and oral steroid groups ( P  = 0.98). While calculating the percentage of patients who were sensitive to glucocorticoid treatment, there was 10.26% in the nasal spray group, 47.37% in the nasal drop group, and 52.50% in the oral steroid group that were sensitive to glucocorticoid treatment. The reduction in NP score was more significant in patients with eosinophilic CRSwNP in the nasal drop group and oral steroid group than in the nasal spray group. However, in patients with non-eosinophilic CRSwNP, the change in NP size was similar in the different treatment groups. Conclusion Budesonide suspension nasal drop can significantly improve the quality of life and reduce the endoscopic score following short-course treatment, and the treatment effect of nasal drop was better than that of regular nasal spray. Budesonide nasal suspension can be used as a regular treatment for eosinophilic CRSwNP and can be an alternative choice for patients with a high percentage of tissue eosinophil infiltration who cannot use oral glucocorticoids.",2020,The reduction in NP score was more significant in patients with eosinophilic CRSwNP in the nasal drop group and oral steroid group than in the nasal spray group.,"['patients with a high percentage of tissue eosinophil infiltration who cannot use oral glucocorticoids', 'patients with chronic rhinosinusitis with nasal polyps', '127 patients with CRSwNP underwent randomization', 'chronic rhinosinusitis', 'Patients who satisfied the criteria of chronic rhinosinusitis with bilateral nasal polyps', 'preoperative CRSwNP patients', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['short-course glucocorticoid application', 'oral methylprednisolone, 24\xa0mg/d and budesonide nasal spray, 256 μg/d, or intranasal budesonide suspension, 1\xa0mg/d and budesonide nasal spray, 256 μg/d, or budesonide nasal spray', 'Budesonide nasal suspension', 'budesonide', 'local glucocorticoids']","['quality of life', 'TNSS', 'NP score', 'Symptoms, endoscopic scores, and tissue and blood inflammatory cells', 'Adverse events', 'total nasal symptoms scores (TNSS', 'NP size', 'endoscopic score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0229610', 'cui_str': 'Tissue eosinophil'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0360556', 'cui_str': 'Methylprednisolone-containing product in oral dose form'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0360546', 'cui_str': 'Budesonide-containing product in nasal dose form'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",127.0,0.0255748,The reduction in NP score was more significant in patients with eosinophilic CRSwNP in the nasal drop group and oral steroid group than in the nasal spray group.,"[{'ForeName': 'Zhaofeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Otorhinolaryngology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Nanjing Medical University, Changzhou, 213003, PR China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}, {'ForeName': 'Wenxiang', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}, {'ForeName': 'Zhaoqi', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}, {'ForeName': 'Yinyan', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.'}]",The World Allergy Organization journal,['10.1016/j.waojou.2020.100131'] 2046,32566096,Enhanced Efficacy of Direct-Acting Antivirals in Hepatitis C Patients by Coadministration of Black Cumin and Ascorbate as Antioxidant Adjuvants.,"The widespread adaptation of a new generation of direct-acting antiviral agents (DAAs) unveils a superlative effect in the eradication of the hepatitis C virus (HCV). However, this therapy has been reported to exhibit vigorous side effects that pose a risk in fleet recovery. This study was conducted to investigate the efficacy of DAAs: sofosbuvir (SOF) and ribavirin (RBV), along with black cumin (BLC) and ascorbate (ASC), as adjuvants on hematological parameters; oxidative stress markers such as total antioxidant status (TAS), superoxide dismutase (SOD), reduced (GSH) and oxidized (GSSG) glutathione (GSH), gamma-glutamyl transferase (GGT), and malondialdehyde (MDA); liver function markers such as aspartate transaminase (AST), alanine aminotransferase (ALT), bilirubin, and alkaline phosphatase (ALP); and viral load with determined genotypes. HCV-infected patients ( n = 30) were randomly divided into two equal groups: control group ( n = 15) and treatment group ( n = 15). The control group was subjected only to SOF and RBV (400 mg each/day). Synergistically, the treatment group was administered with adjuvant therapy of BLC (250 mg/day) and ASC (1000 mg/day) along with DAAs (400 mg each/day) for 8 weeks. All selected patients were subjected to sampling at pre- and posttreatment stages for the assessment of defined parameters. The data revealed that the BLC/ASC adjuvant therapy boosted the efficacy of DAAs by reducing the elevated levels of liver markers such as AST, ALT, ALP, and bilirubin in the treatment group compared with those in the control group ( P > 0.05). The adjuvant therapy synchronously showed an ameliorating effect on hematological parameters. The SOF/RBV with adjuvant therapy also demonstrated an increasing effect in the activity of SOD, TAS, and GSH and a decreasing effect for GSSG, GGT, and malondialdehyde (MDA; P > 0.05) followed by curtailing a RT-PCR-quantified viral load. Our findings provide evidence that systemic administration of BLC/ASC efficiently alleviates hematological, serological, and antioxidant markers as well as the viral load in hepatitis C patients. This highlights a potentially novel role of BLC and ASC in palliating hepatitis C.",2020,"The SOF/RBV with adjuvant therapy also demonstrated an increasing effect in the activity of SOD, TAS, and GSH and a decreasing effect for GSSG, GGT, and malondialdehyde (MDA; P > 0.05) followed by curtailing a RT-PCR-quantified viral load.","['hepatitis C patients', 'Hepatitis C Patients', 'palliating hepatitis C', 'HCV-infected patients ( n = 30']","['Direct-Acting Antivirals', 'SOF and RBV', 'BLC', 'DAAs: sofosbuvir (SOF) and ribavirin (RBV), along with black cumin (BLC) and ascorbate (ASC', 'ASC', 'BLC/ASC']","['hematological parameters', 'activity of SOD, TAS, and GSH', 'elevated levels of liver markers such as AST, ALT, ALP, and bilirubin', 'total antioxidant status (TAS), superoxide dismutase (SOD), reduced (GSH) and oxidized (GSSG) glutathione (GSH), gamma-glutamyl transferase (GGT), and malondialdehyde (MDA); liver function markers such as aspartate transaminase (AST), alanine aminotransferase (ALT), bilirubin, and alkaline phosphatase (ALP); and viral load with determined genotypes']","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}]","[{'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]",30.0,0.0203591,"The SOF/RBV with adjuvant therapy also demonstrated an increasing effect in the activity of SOD, TAS, and GSH and a decreasing effect for GSSG, GGT, and malondialdehyde (MDA; P > 0.05) followed by curtailing a RT-PCR-quantified viral load.","[{'ForeName': 'Sarfraz', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Department of Basic Sciences, University of Veterinary and Animal Sciences, Lahore, 51600, Narowal Campus, Pakistan.'}, {'ForeName': 'Adeela', 'Initials': 'A', 'LastName': 'Zahoor', 'Affiliation': 'Department of Biochemistry, Bahauddin Zakariya University, Multan 60800, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Biochemistry, Bahauddin Zakariya University, Multan 60800, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Younus', 'Affiliation': 'Department of Pathobiology, University of Veterinary and Animal Sciences, Lahore, 51600, Narowal Campus, Pakistan.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Nawaz', 'Affiliation': 'Institute of Biochemistry & Biotechnology, University of Veterinary and Animal Sciences, Lahore, 54000 Lahore, Pakistan.'}, {'ForeName': 'Rahat', 'Initials': 'R', 'LastName': 'Naseer', 'Affiliation': 'Institute of Biochemistry & Biotechnology, University of Veterinary and Animal Sciences, Lahore, 54000 Lahore, Pakistan.'}, {'ForeName': 'Qaiser', 'Initials': 'Q', 'LastName': 'Akram', 'Affiliation': 'Department of Pathobiology, University of Veterinary and Animal Sciences, Lahore, 51600, Narowal Campus, Pakistan.'}, {'ForeName': 'Cun-Liang', 'Initials': 'CL', 'LastName': 'Deng', 'Affiliation': 'Department of Infectious Diseases, The Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'Suvash Chandra', 'Initials': 'SC', 'LastName': 'Ojha', 'Affiliation': 'Department of Infectious Diseases, The Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}]",Oxidative medicine and cellular longevity,['10.1155/2020/7087921'] 2047,32566130,Toward a paradigm shift from deficit-based to proactive speech and language treatment: Randomized pilot trial of the Babble Boot Camp in infants with classic galactosemia.,"Background: Speech and language therapy is typically initiated reactively after a child shows delays. Infants with classic galactosemia (CG), a metabolic disease with a known high risk for both speech and language disorders, hold the keys towards evaluating whether preventive treatment is effective when the risks are known at birth. We present pilot data from a randomized parallel trial of an innovative proactive speech and language intervention program, the Babble Boot Camp (BBC).  Method : Five children with CG, otherwise healthy, participated in the study from approximately 2 to 24 months of age. One of these was randomly selected as control receiving conventional management, which typically starts at age 2-3 years. A pediatric speech-language pathologist met weekly via telepractice with the parents in the treatment cohort. Parents implemented the prespeech, speech, and language stimulation and expansion activities according to the intervention protocol. The control child was still too young for conventional treatment. Primary outcome measures were speech sound production complexity in babble and speech and expressive vocabulary size. Secondary outcome measures were vocalization rates and developmental milestones in communication, motor, and cognition. The trial is ongoing. Results :  All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, three had higher global developmental scores, and two had higher vocalization rates, compared to the control child with CG. Discussion: Given the high risk for speech and language delays in children with CG, finding on-schedule abilities in two or more of the treated children but not the untreated child is unexpected under random conditions. The trends toward beneficial effects of the BBC on speech sound production, expressive language, and communication milestones warrant appropriately powered larger clinical trials with full randomization. Trial registration: ClinicalTrials.gov NCT03838016 (12 th February 2019).",2019,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG. ","['infants with classic galactosemia', 'children with CG', 'Infants with classic galactosemia (CG', 'Method : Five children with CG, otherwise healthy, participated in the BBC from approximately 2 to 24 months of age']","['Babble Boot Camp', 'proactive speech and language treatment', 'control receiving conventional management', 'innovative proactive speech and language intervention program, the Babble Boot Camp (BBC', ': Speech or language therapy']","['speech sound production, expressive language, and communication milestones', 'developmental milestones in communication, motor, and cognition', 'speech sound production complexity in babble and speech and expressive vocabulary size', 'higher communication and personal-social skills', 'higher speech sound skills', 'prespeech, speech, and language stimulation and expansion activities']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0268151', 'cui_str': 'Deficiency of UDPglucose-hexose-1-phosphate uridylyltransferase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023017', 'cui_str': 'Language therapy'}]","[{'cui': 'C0037829', 'cui_str': 'Speech Sounds'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0589217', 'cui_str': 'Language stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",5.0,0.032084,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG. ","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Peter', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Potter', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Donenfeld-Peled', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Finestack', 'Affiliation': 'Department of Speech-Language-Hearing Services, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stoel-Gammon', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lien', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Bruce', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Vose', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Eng', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Olds', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'VanDam', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}]",F1000Research,['10.12688/f1000research.18062.4'] 2048,32566179,Development of omega-3 rich eggs through dietary flaxseed and bio-evaluation in metabolic syndrome.,"An egg is a nutrient-dense food that contains protein, fats, vitamins, and minerals. It is proven that the consumption of eggs influences serum lipid concentration. Therefore, a study was conducted to investigate the effect of normal and omega-3 eggs on serum lipids profiles. Lipids were extracted from egg yolks and analyzed for fatty acids content. The present research is a crossover study design in which 20 participants were recruited randomly, and all subjects received three treatments: no eggs, omega-3 eggs, and normal eggs. However, fasting blood was drawn at baseline and the end of each diet period and analyzed for serum lipids, blood glucose, and insulin level. Omega-3 egg treatment showed reduction in the serum total cholesterol by 16.57 mg/dl ( p  < .001), triglyceride by 17.48 mg/dl, and increase in HDL cholesterol concentration by 0.48 mg/dl ( p  < .001) as compared to no-egg. A significant ( p  < .05) reduction in blood pressure by 8.34/8.67 mm/Hg and insulin level was observed due to omega-3 egg consumption which indicates that omega-3 fatty acids improve insulin sensitivity. On the other hand, regular egg intake elevates serum total cholesterol and triglycerides concentration but decreases blood pressure. It was concluded that omega-3-enriched egg consumption had a positive effect on the serum lipid profile and blood pressure of patients with metabolic syndrome as compared to normal eggs.",2020,"egg treatment showed reduction in the serum total cholesterol by 16.57 mg/dl ( p  < .001), triglyceride by 17.48 mg/dl, and increase in HDL cholesterol concentration by 0.48 mg/dl ( p  < .001) as compared to no-egg.","['20 participants were recruited randomly, and all subjects received three treatments: no eggs, omega-3 eggs, and normal eggs', 'metabolic syndrome']","['omega-3 fatty acids', 'Omega-3', 'normal and omega-3 eggs']","['blood pressure', 'HDL cholesterol concentration', 'serum lipid profile and blood pressure', 'fasting blood', 'serum total cholesterol', 'serum lipids, blood glucose, and insulin level', 'serum total cholesterol and triglycerides concentration', 'triglyceride', 'serum lipids profiles']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",20.0,0.0295513,"egg treatment showed reduction in the serum total cholesterol by 16.57 mg/dl ( p  < .001), triglyceride by 17.48 mg/dl, and increase in HDL cholesterol concentration by 0.48 mg/dl ( p  < .001) as compared to no-egg.","[{'ForeName': 'Hira', 'Initials': 'H', 'LastName': 'Shakoor', 'Affiliation': 'National Institute of Food Science and Technology University of Agriculture Faisalabad Pakistan Faisalabad.'}, {'ForeName': 'Muhammad Issa', 'Initials': 'MI', 'LastName': 'Khan', 'Affiliation': 'National Institute of Food Science and Technology University of Agriculture Faisalabad Pakistan Faisalabad.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Sahar', 'Affiliation': 'National Institute of Food Science and Technology University of Agriculture Faisalabad Pakistan Faisalabad.'}, {'ForeName': 'Muhammad Kashif Iqbal', 'Initials': 'MKI', 'LastName': 'Khan', 'Affiliation': 'Department of Food Engineering University of Agriculture Faisalabad Faisalabad Pakistan.'}, {'ForeName': 'Furukh', 'Initials': 'F', 'LastName': 'Faiz', 'Affiliation': 'Department of Agriculture and Food Technology Karakoram International University Gilgit Pakistan.'}, {'ForeName': 'Hafiz', 'Initials': 'H', 'LastName': 'Basheer Ahmad', 'Affiliation': 'Ayub Agriculture Research Institute Faisalabad Pakistan.'}]",Food science & nutrition,['10.1002/fsn3.1522'] 2049,32563863,DHA-enriched fish oil reduces insulin resistance in overweight and obese adults.,"Adipose tissue inflammation is major factor in the development of insulin resistance (IR). Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are anti-inflammatory bioactive lipids, thus may protect against type 2 diabetes (T2D) development. Previous research has demonstrated a sex-dependent association between LCn-3PUFA and T2D, and evidence suggests LCn-3PUFA may improve IR in a sex-dependent manner. This double-blind, randomized, parallel-arm placebo-controlled study aimed to determine whether DHA-enriched fish oil (FO) supplementation improves IR. Sex-dependent effects were assessed by testing for an interaction between sex and treatment in the multiple regression models. Men and women with abdominal obesity (waist circumference: males, ≥102 cm; females, ≥88 cm) and without diabetes were recruited from the community. Participants (age: 50.9 ± 12.7 years, female: 63.7%, BMI: 32.4 ± 6.6 kg/m 2 ) were randomly allocated to either 2 g FO (860 mg DHA + 120 mg EPA) (intervention, n = 38) or 2 g corn oil (CO) /day (control, n = 35) for 12 weeks in a double-blind randomised controlled trial. A fasting blood sample was collected at 0 and 12 weeks for assessment of IR, glucose and blood lipid profile. Sixty-eight participants completed the intervention. Compared with CO (n = 32), FO (n = 36) significantly reduced fasting insulin by -1.62 μIU/L (95%CI: -2.99, -0.26,) (p = 0.021) and HOMA-IR by -0.40 units (95%CI: -0.78, -0.02, p = 0.038). Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001). There was no interaction between sex and treatment for the change in insulin (p-interaction sex*treatment  = 0.816) or HOMA-IR (p-interaction sex*treatment  = 0.825). DHA-enriched FO reduces IR in adults with abdominal obesity, however, sex-dependent differences were not evident in this study.",2020,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"['overweight and obese adults', 'Participants (age: 50.9\xa0±\xa012.7 years, female: 63.7%, BMI: 32.4\xa0±\xa06.6\xa0kg/m 2 ', 'adults with abdominal obesity', 'Men and women with abdominal obesity (waist circumference: males, ≥102\xa0cm; females, ≥88\xa0cm) and without diabetes were recruited from the community']","['FO (860\xa0mg DHA\xa0+\xa0120\xa0mg EPA) (intervention, n\xa0=\xa038) or 2\xa0g corn oil (CO', 'μIU/L (95%CI', 'DHA-enriched FO', 'DHA-enriched fish oil (FO) supplementation', 'CO', 'Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'DHA-enriched fish oil', 'placebo']","['HOMA-IR', 'insulin resistance', 'IR, glucose and blood lipid profile', 'Higher insulin and HOMA-IR', 'fasting insulin']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",68.0,0.375942,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; School of Health Sciences, University of Newcastle, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'School of Public Health and Medicine, University of Newcastle, Australia; Department of Endocrinology and Diabetes, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: manohar.garg@newcastle.edu.au.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102154'] 2050,32563939,Association of Meteorin-Like Hormone with insulin resistance and body composition in healthy Iranian adults.,"BACKGROUND AND AIMS Sedentary behavior and/or physical inactivity are modifiable risk factors for noncommunicable diseases. Myokines are one of the mediators of physical activity health benefits. Relationship between regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl) has not been explored in human. Hence, we compared baseline plasma Metrnl between sedentary individuals and ones with recreational physical activities, and role of Metrnl as a biological messenger between physical activity and insulin resistance and body composition was also explored. METHODS Forty healthy young men (aged: 21 ± 2.1 yrs; BMI: 23 ± 3.44 kg/m 2 ) completed the study. Participants were equally assigned into two groups of control (sedentary) and case (recreational athletes). Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions. RESULTS Except for baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage were similar between two groups (P > 0.05). However, after Metrnl correction for the degree of insulin resistance index (Metrnl/HOMA-IR), recreational athletes showed a significantly greater baseline compared to sedentary subjects (P < 0.05). Baseline blood glucose showed a negative and significant correlation with baseline plasma Metrnl (P < 0.05). CONCLUSIONS Baseline plasma Metrnl is correlated with regular physical activity and insulin sensitivity, but not with body composition parameters. Metrnl may be one possible mediator of the beneficial effects of PA on insulin sensitivity in healthy humans. Hence, increasing awareness of the benefits of physical activity and incorporating physical activity into lifestyle are of great importance for people with non-communicable diseases.",2020,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions. ","['healthy humans', 'Forty healthy young men (aged: 21\xa0±\xa02.1\xa0yrs', 'people with non-communicable diseases', 'healthy Iranian adults']","['Meteorin-Like Hormone with insulin resistance and body composition', 'regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl']","['Baseline blood glucose', 'degree of insulin resistance index (Metrnl/HOMA-IR', 'baseline plasma Metrnl', 'baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage', 'Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0269477,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions. ","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sport Sciences, University of Mazandaran, Babolsar, Mazandaran, Iran. Electronic address: h.alizadeh.aw@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sports Sciences, University of Shahid Chamran of Ahvaz, Iran. Electronic address: aliakbar.alizadeh1984@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.031'] 2051,32563960,Cost-effectiveness of preoperative magnetic resonance imaging to optimize surgery in ductal carcinoma in situ of the breast.,"PURPOSE Complete surgical excision is the main factor for successful breast-conserving surgery in patients with ductal carcinoma in situ (DCIS) of the breast. Preoperative magnetic resonance imaging (MRI) may allow surgery optimization in this indication. From an economic standpoint, systematic preoperative MRI is associated with an extra cost, which may be offset by a decrease in the number of re-interventions. We performed an economic evaluation alongside IRCIS randomised controlled trial (NCT01112254) to determine whether systematic preoperative MRI in DCIS is a cost-effective strategy. METHODS 360 patients were included in IRCIS trial. Costs were assessed from the French national health insurance perspective. Resource use was prospectively collected during a 6-month period after randomisation. We estimated the mean cost per averted re-intervention. RESULTS Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference: €298 [CI95% : -470; 1063]). There was a non-significant decrease in the rate of re-hospitalisations for positive or close margins (20% in MRI arm versus 27% in No MRI arm, difference -7% [CI95% : -17; 3]). At a willingness to pay of €500 to avert a re-intervention, the probability that MRI strategy is cost-effective was 93%. CONCLUSION Systematic preoperative MRI in patients with DCIS of the breast may be a cost-effective strategy. However, the modest clinical benefit associated with such a strategy limits the interest for this procedure in routine practice given the current MRI techniques.",2020,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","['360 patients were included in IRCIS trial', '€298', 'ductal carcinoma in situ of the breast', 'patients with ductal carcinoma in situ (DCIS) of the breast']","['Preoperative magnetic resonance imaging (MRI', 'preoperative magnetic resonance imaging']","['total costs', 'mean cost per averted re-intervention', 'rate of re-hospitalisations']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",360.0,0.132549,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","[{'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Kandel', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dunant', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Balleyguier', 'Affiliation': 'Gustave Roussy, Department of Medical Imaging, 114 rue Edouard Vaillant, Villejuif, F-94805, France. Electronic address: corinne.balleyguier@gustaveroussy.fr.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bonastre', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109058'] 2052,32564042,Analysis of scoliosis deformation in the Zebris computer study as an assessment of the effectiveness of the FED method in the treatment of idiopathic scolioses.,"Idiopathic scoliosis is one of the most difficult problems of contemporary orthopaedics and physiotherapy, and its unknown etiology hinders initiation of effective causative therapy. A tendency for progression of scoliosis, and failure of many conservative treatment methods stimulated a search for new and more effective methods which will not only stop a progress of the deformation, but actually correct it. The FED method is a relatively new, but promising method used for conservative treatment of idiopathic scoliosis. It is based on the use of a special device, which enables corrective forces to act at a level of the scoliotic curve. AIM The aim of this study was a comparative analysis of effectiveness of idiopathic scoliosis treatment using the FED method versus FITS, during 3 weeks of observations of girls aged 11 to 15 years. MATERIALS AND METHODS The study was conducted in 60 girls, aged from 11 to 15 years (mean 13.58 ± 1.33 years) randomly qualified which were suffered with double-curve scoliosis of the 2nd degree according to Cobb. According to the randomization, the girls were assigned to two groups based on the therapeutic strategy, the study group of patients treated with the FED method, and the control group treated with the FITS method. The therapy results were evaluated by computer examination of the posture using the Zebris CMS10 system. The degree of the spine deformity in the frontal plane was described with the total scoliotic deformation (SD) angle. RESULTS In the conducted study, no statistically significant difference was noted between groups for any of the analyzed variables. It means that these groups did not differ statistically in terms of subjects' number, age, type of scoliosis, Cobb angle value for primary and secondary scoliosis, Risser sign, Raimondi rotation, and scoliosis type. Statistically significant differences were found between the two groups for the scoliosis degree, however, after the therapy, the girls treated with the FED method were characterized by a greater improvement in this parameter versus the control group. CONCLUSIONS Both FED and FITS methods significantly influence the improvement in the scoliotic deformation degree in the Zebris computer examination during a 3-week follow-up; however, when both treatment methods are compared, it can be concluded that the therapy by the FED method is statistically more effective. The treatment of the 2nd degree scolioses with the FED method requires further analyses supplemented with other parameters of postural examination, as well as long-term diagnostics in a larger group of patients.",2020,"Both FED and FITS methods significantly influence the improvement in the scoliotic deformation degree in the Zebris computer examination during a 3-week follow-up; however, when both treatment methods are compared, it can be concluded that the therapy by the FED method is statistically more effective.","['girls aged 11 to 15 years', 'idiopathic scolioses', '60 girls, aged from 11 to 15 years (mean 13.58 ± 1.33 years) randomly qualified which were suffered with double-curve scoliosis of the 2nd degree according to Cobb']",['FED method versus FITS'],"['total scoliotic deformation (SD) angle', 'scoliotic deformation degree']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517500', 'cui_str': '1.33'}, {'cui': 'C0443205', 'cui_str': 'Double curve'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0228685,"Both FED and FITS methods significantly influence the improvement in the scoliotic deformation degree in the Zebris computer examination during a 3-week follow-up; however, when both treatment methods are compared, it can be concluded that the therapy by the FED method is statistically more effective.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Trzcińska', 'Affiliation': 'Orthopaedic-Rehabilitation Centre for Children and Youth in Chylice, Mazovian Center of Rehabilitation ""STOCER"", Konstancin-Jeziorna, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Nowak', 'Affiliation': 'Orthopaedic-Rehabilitation Centre for Children and Youth in Chylice, Mazovian Center of Rehabilitation ""STOCER"", Konstancin-Jeziorna, Poland.'}]",Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego,[] 2053,32564260,"Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.","PURPOSE The Chinese bridging study PUFFIN (NCT02896855) aimed to assess consistency of efficacy with CLEOPATRA (NCT00567190), investigating pertuzumab with trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer. METHODS Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included objective response rate (in patients with measurable baseline disease), overall survival, and safety. The consistency threshold for PFS (hazard ratio [HR] < 0.81) (maintaining ≥ 50% of the risk reduction determined in CLEOPATRA [HR 0.62]) determined the target sample size (n = 240). RESULTS Two hundred forty-three patients were randomized. Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]). Objective responses were recorded in 83/105 (79.0%) and 67/97 (69.1%) patients, respectively. Grade ≥ 3 adverse events (70.5% and 69.2%, respectively) and serious adverse events (19.7% and 19.2%, respectively) were similar across both arms. No heart failure cases or symptomatic left ventricular ejection fraction declines were reported. CONCLUSIONS PUFFIN met its primary objective. Overall, efficacy data were consistent with CLEOPATRA. Safety was consistent with the known pertuzumab safety profile. PUFFIN adds to the totality of data with pertuzumab in previously untreated HER2-positive locally recurrent or metastatic breast cancer and supports the favorable benefit-risk profile of pertuzumab in Chinese patients TRIAL REGISTRATION: ClinicalTrials.gov, NCT02896855, registered 7 September 2016.",2020,"Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]).","['Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN', 'Two hundred forty-three patients were randomized', 'Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status', 'patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer']","['Pertuzumab, trastuzumab, and docetaxel', 'pertuzumab', 'trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel', 'placebo']","['investigator-assessed progression-free survival (PFS', 'Median PFS', 'Grade\u2009≥\u20093 adverse events', 'heart failure cases or symptomatic left ventricular ejection fraction declines', 'measurable baseline disease), overall survival, and safety', 'serious adverse events', 'objective response rate', 'Objective responses']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C1002208', 'cui_str': 'Fratercula'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0449443', 'cui_str': 'Receptor status'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",243.0,0.608416,"Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]).","[{'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China. xubinghe@medmail.com.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The Cancer Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University, Harbin, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou City, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Liaoning, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Roche (China) Holding Ltd, Shanghai, China.'}, {'ForeName': 'Guiyuan', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Restuccia', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05728-w'] 2054,32564334,Long-Term Cilostazol Treatment and Predictive Factors on Outcomes of Endovascular Intervention in Patients with Diabetes Mellitus and Critical Limb Ischemia.,"INTRODUCTION Despite improvements in endovascular interventions and multidisciplinary approaches, improving clinical outcomes and increasing limb salvage have become increasingly challenging. This prospective study investigated the associations of cilostazol treatment with clinical outcomes and predictive factors in patients with diabetes mellitus (DM) and critical limb ischemia (CLI) after endovascular revascularization of the affected angiosome. METHODS In this study, 172 consecutive patients with CLI (Fontaine levels III-IV) received cilostazol treatment after successful endovascular intervention according to the angiosome concept, and their primary patency rates and cardiovascular and amputation events during a 24-month follow-up period were assessed. RESULT The 24-month primary patency rate, mortality rate, and amputation rate were better in the patients under long-term cilostazol treatment (P < 0.001, P = 0.029, and P = 0.014). Weighted multivariate Cox analyses with a propensity scoring-based method showed that long-term cilostazol treatment [hazard ratio (HR) 0.2, 95% confidence interval (CI) 0.11-0.36, P < 0.001], direct revascularization (DR) (HR 0.46, 95% CI 0.28-0.74, P = 0.002), and supervised exercise (HR 0.4, 95% CI 0.24-0.66, P < 0.001) were independently associated with primary patency. Patients with lower-extremity amputation (LEA) had a higher risk of coronary artery disease (CAD) and mortality. Cellulitis and neuropathy were independently associated with LEA events (cellulitis: HR 2.89, 95% CI 1.66-5.05, P < 0.001; neuropathy: HR 2.2, 95% CI 1.31-3.7, P = 0.003). CONCLUSION Our results showed that patients with DM who received cilostazol treatment for more than 3 months had significantly better outcomes and decreased amputation and mortality rates after DR, and cellulitis and neuropathy were highly associated with the risk of limb loss. A large-scale randomized trial should be conducted in the future to confirm these results. TRIAL REGISTRATION Taipei Veterans General Hospital (TVGH) IRB no. 2013-08-020B. Registered 30 August 2013.",2020,"The 24-month primary patency rate, mortality rate, and amputation rate were better in the patients under long-term cilostazol treatment (P < 0.001, P = 0.029, and P = 0.014).","['2013-08-020B', '172 consecutive patients with CLI (Fontaine levels\xa0III-IV) received', 'Patients with lower-extremity amputation (LEA', 'Patients with Diabetes Mellitus and Critical Limb Ischemia', 'Taipei Veterans General Hospital', 'patients with diabetes mellitus (DM) and critical limb ischemia (CLI) after endovascular revascularization of the affected angiosome']","['cilostazol', 'TVGH', 'cilostazol treatment', 'Endovascular Intervention']","['supervised exercise', 'direct revascularization (DR', 'risk of coronary artery disease (CAD) and mortality', 'Cellulitis and neuropathy', 'amputation and mortality rates after DR, and cellulitis and neuropathy', '24-month primary patency rate, mortality rate, and amputation rate', 'risk of limb loss']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0411282', 'cui_str': 'Endovascular radiological intervention'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}]",172.0,0.0628399,"The 24-month primary patency rate, mortality rate, and amputation rate were better in the patients under long-term cilostazol treatment (P < 0.001, P = 0.029, and P = 0.014).","[{'ForeName': 'Chiu-Yang', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Taipei Veterans General Hospital, No. 201, Section\xa02 Shih-Pai Road, Beitou District, Taipei, 11217, Taiwan.'}, {'ForeName': 'Tao-Cheng', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. dcwu@vghtpe.gov.tw.'}, {'ForeName': 'Shing-Jong', 'Initials': 'SJ', 'LastName': 'Lin', 'Affiliation': 'Institute of Clinical Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan. shingjong88@gmail.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00860-8'] 2055,32564340,A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies.,"INTRODUCTION Clinicians, payers, guideline committees, and policymakers support the use of high-intensity statins in patients at high risk for complications of cardiovascular disease (CVD). Guidelines and recommendations provide guidance on next steps for patients with inadequate low-density lipoprotein cholesterol (LDL-C) control on maximally tolerated statin or for those who are statin-intolerant. Ezetimibe and evolocumab improve CV outcomes when added to statins in high-CV-risk populations. The aim of the study was to compare evolocumab and ezetimibe for lipid-lowering efficacy and safety. METHODS We summarized data from 1427 patients from three phase 3 evolocumab studies comparing double-blinded evolocumab vs. ezetimibe. These studies evaluated four distinct populations: those free of CVD receiving each agent as monotherapy, patients with CVD receiving add-on therapy to low- or high-intensity statin, and statin-intolerant patients. Lipid efficacy and safety were reported at week 12. RESULTS Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001). This corresponded to absolute reductions in LDL-C of 60-104 mg/dL with evolocumab vs. 17-35 mg/dL with ezetimibe. Evolocumab also significantly improved other lipids and led to a higher percentage of patients achieving LDL-C goals vs. ezetimibe. Adverse events and discontinuation rates (oral and parenteral therapy) were balanced across groups, suggesting good tolerance and acceptance of both treatments. CONCLUSIONS Evolocumab outperformed ezetimibe in efficacy and lipid goal attainment. Both products demonstrated good safety/tolerability. These data may help guide access decisions for high-risk patients with inadequate treatment response or intolerance to statin therapy.",2020,"Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001).","['patients with CVD receiving add-on therapy to low- or high-intensity statin, and statin-intolerant patients', 'patients with inadequate low-density lipoprotein cholesterol (LDL-C) control on maximally tolerated statin or for those who are statin-intolerant', 'patients at high risk for complications of cardiovascular disease (CVD', 'Four Patient Populations', 'high-risk patients with inadequate treatment response or intolerance to statin therapy', '1427 patients from three phase 3 evolocumab studies comparing double-blinded']","['ezetimibe', 'evolocumab and ezetimibe', 'evolocumab vs. ezetimibe', 'Ezetimibe and evolocumab', 'Ezetimibe and Evolocumab']","['CV outcomes', 'Lipid efficacy and safety', 'good safety/tolerability', 'LDL-C', 'Adverse events and discontinuation rates (oral and parenteral therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",1427.0,0.170858,"Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, 4085 University Blvd. South, Suite 1, Jacksonville, FL, 32216, USA. mkoren@encoredocs.com.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Jones', 'Affiliation': 'Baylor College of Medicine, 6655 Travis St., Suite 320, Houston, TX, 77030, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': 'University of Iowa, 145 N. Riverside Dr, Iowa City, IA, 52246, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sullivan', 'Affiliation': 'Department of Clinical Biochemistry, Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050, Australia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Cleveland Clinic, 9500 Euclid Ave., Desk JB1, Cleveland, OH, 44195, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hucko', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'J Antonio G', 'Initials': 'JAG', 'LastName': 'Lopez', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Alex N', 'Initials': 'AN', 'LastName': 'Fleishman', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Ransi', 'Initials': 'R', 'LastName': 'Somaratne', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Stroes', 'Affiliation': 'Academic Medical Center of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Amsterdam, The Netherlands.'}]",Cardiology and therapy,['10.1007/s40119-020-00181-8'] 2056,32564365,"Effect of intra-operative intravenous lidocaine on opioid consumption after bariatric surgery: a prospective, randomised, blinded, placebo-controlled study.","Peri-operative lidocaine infusion warrants investigation in bariatric surgery because obese patients present different physiological and pharmacological risks. This single-centre, prospective, randomised double-blind placebo-controlled study enrolled obese patients scheduled for laparoscopic bariatric surgery using an enhanced recovery protocol. Patients received either lidocaine (bolus of 1.5 mg.kg -1 , then a continuous infusion of 2 mg.kg -1 .h -1 until the end of the surgery, then 1 mg.kg -1 .h -1 for 1 h in the recovery area) or identical volumes and rates of 0.9% saline. The primary outcome was the consumption of the equivalent of oxycodone consumption over the first 3 postoperative days. Secondary outcomes were: postoperative pain; incidence of nausea and vomiting; bowel function recovery; and lengths of stay in the recovery area and in hospital. Plasma concentrations of lidocaine were measured. On the 178 patients recruited, data were analysed from 176. The median (IQR [range]) equivalent intravenous oxycodone consumption was 3.3 mg (0.0-6.0 [0.0-14.5]) and 5.0 mg (3.3-7.0 [3.3-20.0]) in the lidocaine and saline groups, respectively (difference between medians (95%CI): 1.7 (0.6-3.4) mg; p = 0.004). Length of stay in the recovery area, postoperative pain, nausea and vomiting, day of recovery of bowel function, and length of stay in hospital were not different between groups. Mean (SD) lidocaine plasma concentrations were 2.44 (0.70) µg.ml -1 and 1.77 (0.51) µg.ml -1 at the end of surgery and 1 hour after the end of infusion, respectively. Lidocaine infusion during bariatric surgery resulted in a clinically non-relevant difference in postoperative oxycodone consumption.",2020,Lidocaine infusion during bariatric surgery resulted in a clinically non-relevant difference in postoperative oxycodone consumption.,"['after bariatric surgery', 'bariatric surgery because obese patients', 'enrolled obese patients scheduled for laparoscopic bariatric surgery using an enhanced recovery protocol', '178 patients recruited, data were analysed from 176']","['placebo', 'Lidocaine', 'lidocaine', 'intra-operative intravenous lidocaine']","['postoperative pain; incidence of nausea and vomiting; bowel function recovery; and lengths of stay in the recovery area and in hospital', 'median (IQR [range]) equivalent intravenous oxycodone consumption', 'consumption of the equivalent of oxycodone consumption', 'Length of stay in the recovery area, postoperative pain, nausea and vomiting, day of recovery of bowel function, and length of stay in hospital', 'postoperative oxycodone consumption', 'Plasma concentrations of lidocaine', 'opioid consumption', 'Mean (SD) lidocaine plasma concentrations']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",178.0,0.59546,Lidocaine infusion during bariatric surgery resulted in a clinically non-relevant difference in postoperative oxycodone consumption.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Plass', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nicolle', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zamparini', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Al Issa', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Fiant', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Le Roux', 'Affiliation': 'Department of Digestive and Bariatric Surgery, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Gérard', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'M O', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alvès', 'Affiliation': 'Department of Digestive and Bariatric Surgery, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Peri-operative Care, CHU de Caen Normandie, Caen, France.'}]",Anaesthesia,['10.1111/anae.15150'] 2057,32564438,"Regular supplementation with resveratrol improves bone mineral density in postmenopausal women: a randomised, placebo-controlled trial.","Resveratrol, a naturally-occurring polyphenol in red grapes and berries, can act as a phytoestrogen. It has been shown to improve both systemic and cerebral circulatory functions, possibly through activation of endothelial estrogen receptors. In vitro and in vivo studies in rodent models also indicate a bone-protective role for resveratrol, particularly in ovariectomised rat models that mimic postmenopausal osteoporosis caused by estrogen deficiency. Hypothesising a circulatory benefit of resveratrol in bone tissue, we investigated whether resveratrol supplementation could improve bone health in postmenopausal women. The Resveratrol for Healthy Ageing in Women (RESHAW) trial was a 24-month randomised, double-blind, placebo-controlled, two-period crossover intervention conducted to evaluate the effects of resveratrol (75mg twice daily) on cognition, cerebrovascular function, bone health, cardiometabolic markers and well-being in postmenopausal women. Following 12 months of supplementation with resveratrol versus placebo, there were positive effects on bone density in the lumbar spine (+0.016±0.003 g/cm 2 ) and neck of femur (+0.005±0.002 g/cm 2 ), which were accompanied by a 7.24% reduction in C-terminal telopeptide type-1 collagen levels, a bone resorption marker, compared to placebo. The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070±0.018) and a reduction in the 10-year probability of major and hip fracture risk. The magnitude of improvement was higher in women with poor bone health biomarker status. Importantly, the improvement in femoral neck T-score with resveratrol correlated with improvement in perfusion. Our sub-analysis also revealed that the bone-protective benefit of resveratrol was greater in participants who supplemented with vitamin D plus calcium. Regular supplementation with 75mg of resveratrol twice daily has the potential to slow bone loss in the lumbar spine and femoral neck, common fracture sites in postmenopausal women without overt osteoporosis. This article is protected by copyright. All rights reserved.",2020,The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070±0.018) and a reduction in the 10-year probability of major and hip fracture risk.,"['postmenopausal women', 'women with poor bone health biomarker status', 'postmenopausal women without overt osteoporosis']","['resveratrol', 'placebo', 'vitamin D plus calcium', 'Regular supplementation with resveratrol', 'resveratrol supplementation']","['bone mineral density', 'bone density', 'femoral neck T-score', 'cognition, cerebrovascular function, bone health, cardiometabolic markers', 'bone health', '10-year probability of major and hip fracture risk']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.247533,The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070±0.018) and a reduction in the 10-year probability of major and hip fracture risk.,"[{'ForeName': 'Rachel Hx', 'Initials': 'RH', 'LastName': 'Wong', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales, 2308, Australia.'}, {'ForeName': 'Jay Jay Thaung', 'Initials': 'JJT', 'LastName': 'Zaw', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales, 2308, Australia.'}, {'ForeName': 'Cory J', 'Initials': 'CJ', 'LastName': 'Xian', 'Affiliation': 'UniSA Clinical & Health Sciences and Cancer Research Institute, University of South Australia, Adelaide, South Australia, 5000, Australia.'}, {'ForeName': 'Peter Rc', 'Initials': 'PR', 'LastName': 'Howe', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales, 2308, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4115'] 2058,32564453,Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: a two-year randomised evaluation study.,"BACKGROUND Use of topical glaucoma medications has been reported to cause ocular surface (OS) discomfort and inflammation. This study explores the profile of inflammatory cytokines and OS symptoms induced in response to preserved and non-preserved drops. METHODS Prospective, randomized evaluation on thirty-six treatment-naïve patients over 24 months of three differently preserved glaucoma drop preparations: Preservative-free (PF), Polyquad (PQ), and Benzalkonium chloride (BAK). Study participants were evaluated at baseline and then at 1, 3, 6, 12 and 24 months whilst on medication. At each visit, participants completed the Ocular Surface disease index (OSDI) questionnaire, had basal tear sampling and impression cytology (IC) of the conjunctival epithelium. Quantitative polymerase chain reaction was performed to measure the gene expression of inflammatory cytokines (Interleukin (IL)-6, IL-8, IL-10, IL-12A, IL-12B, IL-17A, IL-1β, and tumour necrosis factor (TNF)-α) in the IC samples. Corresponding protein expression of cytokines in tear samples was assessed by the Becton-Dickinson cytometric bead arrays. RESULTS Compared to PF and PQ groups, mRNA and protein expression of IL-6, IL-8, and IL-1β increased in samples from the BAK group in a time-dependent fashion, whereas all other cytokines showed a non-significant increase. In the BAK group, there was a strong correlation between OSDI and the levels of IC/IL-1β (r=0.832, R squared=0.692 and p=0.040); IC/IL-10 (r=0.925, R squared=0.856 and p=0.008) and tear/IL-1β (r=0.899, R squared=0.808 and p=0.014). CONCLUSION BAK-preserved topical drops stimulate a sterile inflammatory response on the OS within 3-months which is maintained thereafter. Whereas PF-drops and PQ-preserved drops showed no significant OS inflammation.",2020,"In the BAK group, there was a strong correlation between OSDI and the levels of IC/IL-1β (r=0.832, R squared=0.692 and p=0.040); IC/IL-10 (r=0.925, R squared=0.856 and p=0.008) and tear/IL-1β",['thirty-six treatment-naïve patients over 24 months of three differently preserved glaucoma drop preparations'],"['Preservative-free (PF), Polyquad (PQ), and Benzalkonium chloride (BAK']","['mRNA and protein expression of IL-6, IL-8, and IL-1β', 'tear/IL-1β', 'OSDI and the levels of IC/IL-1β', 'OS inflammation', 'gene expression of inflammatory cytokines (Interleukin (IL)-6, IL-8, IL-10, IL-12A, IL-12B, IL-17A, IL-1β, and tumour necrosis factor (TNF)-α', 'Ocular Surface disease index (OSDI) questionnaire, had basal tear sampling and impression cytology (IC) of the conjunctival epithelium']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0071668', 'cui_str': 'polyquaternium 1'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium chloride'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1121403', 'cui_str': 'IL-12p35'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}]",,0.0697721,"In the BAK group, there was a strong correlation between OSDI and the levels of IC/IL-1β (r=0.832, R squared=0.692 and p=0.040); IC/IL-10 (r=0.925, R squared=0.856 and p=0.008) and tear/IL-1β","[{'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Kulkarni', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Lana A', 'Initials': 'LA', 'LastName': 'Faraj', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Academic Ophthalmology, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13814'] 2059,32564459,"Single-layered versus multiple-layered wound closure for flank incision: Results of a prospective, randomized, double-blinded multicenter study.","OBJECTIVE To compare the incidence of postoperative flank bulges between patients with multiple-layer closure and single superficial-layer closure after retroperitoneal surgery via open flank incision. PATIENTS AND METHODS The study was a randomized controlled, patient- and assessor-blinded, multicenter trial. Between May 2015 and February 2017, 225 patients undergoing flank incision were randomized 1:1 to a multiple-layered closure (SIMULAC-I) and a single superficial layered closure (SIMULAC-II) group. The primary outcome was the occurrence of a flank bulge 6 months after surgery. RESULTS Overall, 177 patients (90 SIMULAC-I, 87 SIMULAC-II) were eligible for final assessment. The cumulative incidence of a flank bulge was significantly higher in the SIMULAC-II group (51.7%) compared to the SIMULAC-I group (34.4%; OR 2.04 (1.11-3.73), P = 0.02). Rate of severe postoperative complications (4.4% (SIMULAC-I) vs. 10.3% (SIMULAC-II); P = 0.21) or hernia (6.7% (SIMULAC-I) vs. 10.3% (SIMULAC-II); P = 0.59) was similar between both groups. A difference in pain (visual analogue scale) and the requirement for pain medication 6 months postoperatively, was not observed. Quality of life assessed with the EQ-5D was higher in the SIMULAC-I group compared to the SIMULAC-II group 6 months postoperatively (80 [30-100] vs. 75 [5-100]; P = 0.012). CONCLUSION The overall risk of a flank bulge after flank incision is high. Multiple layer closure after flank incision should be performed as a standard procedure.",2020,"Quality of life assessed with the EQ-5D was higher in the SIMULAC-I group compared to the SIMULAC-II group 6 months postoperatively (80 [30-100] vs. 75 [5-100]; P = 0.012). ","['patients with multiple-layer closure and single superficial-layer closure after retroperitoneal surgery via open flank incision', '177 patients (90 SIMULAC-I, 87 SIMULAC-II) were eligible for final assessment', 'Between May 2015 and February 2017, 225 patients undergoing flank incision']","['Single-layered versus multiple-layered wound closure for flank incision', 'multiple-layered closure (SIMULAC-I) and a single superficial layered closure (SIMULAC-II) group']","['overall risk of a flank bulge', 'Rate of severe postoperative complications', 'occurrence of a flank bulge 6 months after surgery', 'pain (visual analogue scale', 'cumulative incidence of a flank bulge', 'hernia', 'Quality of life assessed with the EQ-5D']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198492', 'cui_str': 'Incision of flank'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517652', 'cui_str': '225'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0198492', 'cui_str': 'Incision of flank'}, {'cui': 'C1293123', 'cui_str': 'Layered closure - action'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",225.0,0.134905,"Quality of life assessed with the EQ-5D was higher in the SIMULAC-I group compared to the SIMULAC-II group 6 months postoperatively (80 [30-100] vs. 75 [5-100]; P = 0.012). ","[{'ForeName': 'Maximilian C', 'Initials': 'MC', 'LastName': 'Kriegmair', 'Affiliation': 'Department of Urology, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Younsi', 'Affiliation': 'Department of Urology, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Kiriaki', 'Initials': 'K', 'LastName': 'Hiller', 'Affiliation': 'Department of Urology, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Leitsmann', 'Affiliation': 'Department of Urology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Kowalewski', 'Affiliation': 'Department of Urology, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Siegel', 'Affiliation': 'Department of Urology, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rothamel', 'Affiliation': 'Urological Hospital Munich-Planegg, Munich-Planegg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ritter', 'Affiliation': 'Department of Urology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bolenz', 'Affiliation': 'Department of Urology, University of Ulm, Ulm, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kriegmair', 'Affiliation': 'Urological Hospital Munich-Planegg, Munich-Planegg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Trojan', 'Affiliation': 'Department of Urology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Maurice S', 'Initials': 'MS', 'LastName': 'Michel', 'Affiliation': 'Department of Urology, University Hospital Manheim, Mannheim, Germany.'}]",BJU international,['10.1111/bju.15148'] 2060,32564466,Study of anorectal dynamics in patients undergoing laparoscopic ultra-low resection and transanal intersphincteric resection for rectal cancer.,"BACKGROUND Quite a few studies on anal functions after open total mesorectal excision combined with transanal intersphincteric resection (ISR) have been reported, but there is little literature on anal function after laparoscopic total mesorectal excision (LTME) combined with transanal ISR. The aim of this study was to explore the post-operative anorectal dynamic changes in ultra-low rectal cancer patients undergoing LTME combined with transanal ISR. METHODS The data of 26 ultra-low rectal cancer patients undergoing LTME + transanal ISR were analysed. A total of 30 patients undergoing laparoscopic low anterior resection by the same surgeons during the same period were randomly enrolled into the control group. RESULTS There were no differences in the preoperative anorectal manometry data and Wexner anal function scores between the observation group and the control group (P > 0.05). There were no significant differences in the mean operation time, the mean amount of bleeding and the mean post-operative hospital stay between the two groups (P > 0.05). The mean follow-up time was 16 months. No recurrence and metastasis were found in all cases. At 3 and 6 months after the operation, there were significant differences in the anorectal manometry data and Wexner anal function scores between the two groups (P < 0.05). However, at 1 year after the operation, there were no significant differences in the anorectal manometry data and Wexner anal function scores between the two groups (P > 0.05). CONCLUSION Laparoscopic ISR for ultra-low rectal cancer is technically feasible, but the surgical indications should be strictly defined.",2020,"There were no significant differences in the mean operation time, the mean amount of bleeding and the mean post-operative hospital stay between the two groups (P > 0.05).","['for rectal cancer', '26 ultra-low rectal cancer patients undergoing LTME\u2009+\u2009transanal ISR', '30 patients undergoing laparoscopic low anterior resection by the same surgeons during the same period were randomly enrolled into the control group', 'ultra-low rectal cancer patients undergoing LTME combined with transanal ISR', 'patients undergoing']","['transanal intersphincteric resection (ISR', 'Laparoscopic ISR', 'laparoscopic ultra-low resection and transanal intersphincteric resection', 'laparoscopic total mesorectal excision (LTME) combined with transanal ISR']","['anorectal manometry data and Wexner anal function scores', 'recurrence and metastasis', 'preoperative anorectal manometry data and Wexner anal function scores', 'mean operation time, the mean amount of bleeding and the mean post-operative hospital stay']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C0232722', 'cui_str': 'Anal function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",30.0,0.0387302,"There were no significant differences in the mean operation time, the mean amount of bleeding and the mean post-operative hospital stay between the two groups (P > 0.05).","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Department of Gastrointestinal Surgery, The First People's Hospital of Foshan (Foshan Hospital of Sun Yat-sen University), Foshan, China.""}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""Department of Gastrointestinal Surgery, The First People's Hospital of Foshan (Foshan Hospital of Sun Yat-sen University), Foshan, China.""}, {'ForeName': 'Tedong', 'Initials': 'T', 'LastName': 'Luo', 'Affiliation': ""Department of Gastrointestinal Surgery, The First People's Hospital of Foshan (Foshan Hospital of Sun Yat-sen University), Foshan, China.""}, {'ForeName': 'Zuojun', 'Initials': 'Z', 'LastName': 'Zhen', 'Affiliation': ""Department of Gastrointestinal Surgery, The First People's Hospital of Foshan (Foshan Hospital of Sun Yat-sen University), Foshan, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': ""Department of Gastrointestinal Surgery, The First People's Hospital of Foshan (Foshan Hospital of Sun Yat-sen University), Foshan, China.""}]",ANZ journal of surgery,['10.1111/ans.16077'] 2061,32564482,Randomised trial of telephone counselling to improve participants' adherence to prescribed drugs in a cardiovascular screening trial. A VIVA substudy.,"A total of 1,446 participants; 65-74-year-old men diagnosed with abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD) or high blood pressure (HB) in the Viborg Vascular (VIVA) screening trial, were consecutively included and randomised to a telephone counselling (TC) or no TC 3 months after being screened positive. Data from VIVA were linked to data from Danish registers from 2007 to 2016. The primary outcome was a composite outcome of proportion of days covered (PDC) by statin, antithrombotic drugs and antihypertensive agents and for each specific drug class at 6-month follow-up. The same outcomes were assessed at 12 and 60 months and considered secondary outcomes. Outcome measures are reported as risk differences (RD). There were no differences between the groups in relation to the composite of all three drug classes over 6 months of follow-up, RD = 4.1 (95%CI: -1.0; 9.1). A significant increase in redeemed statin prescriptions was observed in the intervention group at 6 months, RD = 9.8% (CI 95%: 0.5; 19.0). There was no intervention effect observed after 12 and 60 months. TC 3 months after screening improved adherence to statin at 6-month follow-up, but had no effect on the composite treatment, statins, antithrombotic or antihypertensive treatment over 60 months of follow-up.",2020,"There were no differences between the groups in relation to the composite of all three drug classes over 6 months of follow-up, RD = 4.1 (95%CI: -1.0; 9.1).","[""participants' adherence to prescribed drugs in a cardiovascular screening trial"", '1,446 participants; 65-74-year-old men diagnosed with abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD) or high blood pressure (HB) in the Viborg Vascular (VIVA) screening trial']","['telephone counselling', 'telephone counselling (TC) or no TC']","['redeemed statin prescriptions', 'risk differences (RD', 'composite outcome of proportion of days covered (PDC) by statin, antithrombotic drugs and antihypertensive agents and for each specific drug class']","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1446.0,0.163178,"There were no differences between the groups in relation to the composite of all three drug classes over 6 months of follow-up, RD = 4.1 (95%CI: -1.0; 9.1).","[{'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Qvist', 'Affiliation': 'Department of Cardiology, Diagnostic Centre, Regional Hospital Central Jutland, Silkeborg, Denmark.'}, {'ForeName': 'Jes S', 'Initials': 'JS', 'LastName': 'Lindholt', 'Affiliation': 'Department of Vascular Surgery, Regional Hospital Central Jutland, Viborg, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Søgaard', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Lorentzen', 'Affiliation': 'The Centre for Nursing Research, Viborg, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Hallas', 'Affiliation': 'Department of Clinical Chemistry & Pharmacology, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frost', 'Affiliation': 'Department of Cardiology, Diagnostic Centre, Regional Hospital Central Jutland, Silkeborg, Denmark.'}]",Basic & clinical pharmacology & toxicology,['10.1111/bcpt.13459'] 2062,32564489,"Effects of Combined Use of Mother's Breast Milk, Heartbeat Sounds, and Non-Nutritive Sucking on Preterm Infants' Behavioral Stress During Venipuncture: A Randomized Controlled Trial.","PURPOSE Even routine procedures can cause pain and stress, and can be harmful to the fast-growing brain of preterm infants. Mitigating pain and stress with sucrose and analgesics has side effects; thus, an alternate choice is the use of natural breast milk and infants' sensory capabilities. Therefore, this study examined the effects of different integrations of sensory experiences-mother's breast milk odor and taste (BM-OT), heartbeat sounds (HBs), and non-nutritive sucking (NNS)-on preterm infant's behavioral stress during venipuncture. DESIGN This study was a prospective, randomized controlled trial. METHODS Infants born preterm (<37 weeks' gestational age) were enrolled in the study through convenience sampling, and randomly assigned to the following conditions: (condition 1) routine care (n = 36); (condition 2) BM-OT (n = 33); (condition 3) BM-OT + HBs (n = 33); or (condition 4) BM-OT + HBs + NNS (n = 36). Crying duration from puncture to recovery period was recorded using a voice recorder. Facial actions and body movements were measured using an infant behavioral coding scheme and transformed into frequencies during seven stages: baseline (stage 0), disinfecting (stage 1), venipuncture (stage 2), and the recovery period for 10 minutes (stages 3-6). FINDINGS Data were analyzed for 138 preterm infants. The corresponding median times to stop crying for conditions 1, 2, 3, and 4 were 137, 79, 81, and 39 s, respectively; the instantaneous occurrence rates of stopping crying for conditions 2, 3, and 4 were 1.469, 1.574, and 2.996 times greater than for condition 1, respectively. Infants receiving conditions 3 and 4 had significantly fewer occurrences of facial actions (stage 6 and stages 4-6, respectively) and body movements (stages 3-6 for both); however, there were no significant reductions in stress behaviors for condition 2 (BM-OT). CONCLUSIONS The combination of BM-OT, HBs, and NNS could be provided to preterm infants as interventions to prevent and reduce behavioral stress, and facilitate pain recovery during venipuncture procedures. CLINICAL RELEVANCE Clinicians should be educated about how to recognize preterm infants' behavioral stress, and to incorporate different sensory combinations of respective mothers' BM, HBs, and NNS into painful procedures to help preterm infants recover from distress.",2020,"Infants receiving conditions 3 and 4 had significantly fewer occurrences of facial actions (stage 6 and stages 4-6, respectively) and body movements (stages 3-6 for both); however, there were no significant reductions in stress behaviors for condition 2 (BM-OT). ","[""Infants born preterm (<37 weeks' gestational age"", 'preterm infants', ""Preterm Infants' Behavioral Stress During Venipuncture"", 'condition 1) routine care (n = 36', '138 preterm infants']","[""sensory experiences-mother's breast milk odor and taste (BM-OT), heartbeat sounds (HBs), and non-nutritive sucking"", 'Nutritive Sucking', ""Combined Use of Mother's Breast Milk, Heartbeat Sounds, and Non""]","['stress behaviors', 'instantaneous occurrence rates of stopping crying', 'Crying duration', 'body movements', 'Facial actions and body movements', 'median times to stop crying', 'occurrences of facial actions']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",138.0,0.0859147,"Infants receiving conditions 3 and 4 had significantly fewer occurrences of facial actions (stage 6 and stages 4-6, respectively) and body movements (stages 3-6 for both); however, there were no significant reductions in stress behaviors for condition 2 (BM-OT). ","[{'ForeName': 'Hsiang-Ping', 'Initials': 'HP', 'LastName': 'Wu', 'Affiliation': 'Lambda Beta-At-Large, Doctoral Student, Graduate Institute of Medical Sciences, National Defense Medical Center, Taipei City, Taiwan, R.O.C, and Lecturer, Department of Nursing, Chung-Jen Junior College of Nursing, Health Sciences and Management, Chiayi, Taiwan, R.O.C.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Associate Professor, Department of Social Work, Hsuan Chuang University, Hsinchu, Taiwan, R.O.C.'}, {'ForeName': 'Hsiang-Yun', 'Initials': 'HY', 'LastName': 'Lan', 'Affiliation': 'Lambda Beta-At-Large, Assistant Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Hsueh-Fang', 'Initials': 'HF', 'LastName': 'Peng', 'Affiliation': 'Registered Nurse, Department of Nursing, Taipei Veteran General Hospital, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Yue-Cune', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Professor, Department of Mathematics, Tamkang University, Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Mei-Jy', 'Initials': 'MJ', 'LastName': 'Jeng', 'Affiliation': ""Professor, Department of Pediatrics, Children's Medical Center, Taipei Veterans General Hospital, Taipei, Taiwan, R.O.C.""}, {'ForeName': 'Jen-Jiuan', 'Initials': 'JJ', 'LastName': 'Liaw', 'Affiliation': 'Lambda Beta-At-Large, Professor, School of Nursing, National Defense Medical Center, Taipei City, Taiwan, R.O.C.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12571'] 2063,32564493,Quilting suture versus conventional closure in prevention of seroma after total mastectomy and axillary dissection in breast cancer patients.,"BACKGROUND Total mastectomy and axillary dissection is a common procedure for breast cancer patients in our institution. Seroma is common. This study aimed to compare the quilting suture and conventional closure in prevention of seroma after total mastectomy and axillary dissection. METHODS This randomized comparative study was carried out from January 2018 to June 2019 in Yangon General Hospital. One hundred and forty patients (70 conventional and 70 quilting) were included. For quilting group, customized strategically placed interrupted alternate sutures were placed 2-3 cm apart with 3/0 vicryl sutures between skin flap and pectoral muscle. RESULTS Age, body mass index and tumour diameter were comparable between the groups. The mean duration of operation was 111.44 ± 7.045 min in conventional and 124.5 ± 6.39 min in quilting (P = 0.0001). The mean drain output for conventional group was not significantly different from quilting group. In quilting, some area developed dimpling which resolved within a week. A total of 21 (30%) patients in the conventional group and 10 patients (14.3%) in the quilting group developed seroma (P = 0.041). The mean frequency and amount of seroma aspiration were significantly lower in the quilting group. Shoulder movement limitation and analgesia use showed no significant difference. CONCLUSION Although total amount of drain output, duration of drain, hospital stay and post-operative complications were not different, the incidence of seroma was significantly lower in quilting group. Seroma is treated with more ease in the quilting group as the frequency and amount of aspiration were lower and less frequent follow-up visits were required. Quilting can reduce the seroma incidence in total mastectomy and axillary dissection for breast cancer patients.",2020,"Shoulder movement limitation and analgesia use showed no significant difference. ","['breast cancer patients', 'One hundred and forty patients (70 conventional and 70 quilting) were included', 'breast cancer patients in our institution', 'January 2018 to June 2019 in Yangon General Hospital']","['customized strategically placed interrupted alternate sutures were placed 2-3 cm apart with 3/0 vicryl sutures between skin flap and pectoral muscle', 'Total mastectomy and axillary dissection', 'quilting suture and conventional closure', 'Quilting suture versus conventional closure']","['incidence of seroma', 'mean duration of operation', 'mean frequency and amount of seroma aspiration', 'seroma', 'total amount of drain output, duration of drain, hospital stay and post-operative complications', 'mean drain output', 'seroma incidence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4044304', 'cui_str': 'Quilt'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1576039', 'cui_str': 'Vicryl suture'}, {'cui': 'C1562051', 'cui_str': 'Skin flap'}, {'cui': 'C0030747', 'cui_str': 'Pectoral muscle structure'}, {'cui': 'C2960728', 'cui_str': 'Total mastectomy and axillary dissection'}, {'cui': 'C4044304', 'cui_str': 'Quilt'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0290088,"Shoulder movement limitation and analgesia use showed no significant difference. ","[{'ForeName': 'Sie Thu', 'Initials': 'ST', 'LastName': 'Myint', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Khin San', 'Initials': 'KS', 'LastName': 'Khaing', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Yee', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Soe Myat', 'Initials': 'SM', 'LastName': 'Mon', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Thein', 'Initials': 'T', 'LastName': 'Lwin', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}]",ANZ journal of surgery,['10.1111/ans.16091'] 2064,32566244,A self-management support intervention for patients with atrial fibrillation: a randomized controlled pilot trial.,"Background Atrial fibrillation (AF) is the most common arrhythmia worldwide. Despite effective treatment, it is characterized by frequent recurrences. Optimal therapeutic management of AF requires active participation and self-management from patients. Two major components of self-management are self-monitoring and sign-and-symptom management. Pulse self-palpation (PSP) is a method of self-monitoring; however, not all AF patients are capable of successfully performing PSP. Due to a lack of interventions on this topic, a nurse-led intervention for patients with AF (PSPAF intervention) was developed to foster self-monitoring and to enhance self-management through PSP. The purpose of this pilot study was to test the acceptability, feasibility, and potential effects of this intervention on the capability of patients' PSP and sign-and-symptom management. Moreover, we aimed at gathering data on the feasibility of applied research methods to aid in the design of future studies. Methods The pilot trial involved 20 adult patients with AF, randomized to an intervention or usual care group. At baseline and during a home visit 3-5 weeks later, we collected data using questionnaires, checklists, field notes, a mobile ECG device, and a diary. Acceptability and feasibility measures were validated through predefined cut-off points. Effect size estimates were expressed as relative risks (RR) and the number needed to treat (NNT). Results The PSPAF intervention seemed feasible, but only partly acceptable. There were limitations in terms of potential effectiveness, suitability, addressing participants' willingness to implement its content in daily life, and adherence. Estimations of effect sizes suggest a large effect of the intervention on patients' PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0). The feasibility of applied research methods showed minor limitations on recruitment and participant burden. Conclusions Despite some limitations, the intervention seemed to be applicable and promising. Taking into account the suggestions and amendments we have made, we recommend conducting a full-scale trial to examine the efficacy of the PSPAF intervention. Trial registration This pilot study was registered in the German Clinical Trials Register at September 4, 2017 (Main ID: DRKS00012808).",2020,"Estimations of effect sizes suggest a large effect of the intervention on patients' PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0).","[""patients' PSP and sign-and-symptom management"", '20 adult patients with AF', 'patients with atrial fibrillation', 'patients with AF (PSPAF intervention']","['self-management support intervention', 'PSPAF intervention', 'Pulse self-palpation (PSP', 'intervention or usual care group']","[""patients' PSP capability"", 'sign-and-symptom management', 'Acceptability and feasibility measures', 'relative risks (RR) and the number needed to treat (NNT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",20.0,0.0988538,"Estimations of effect sizes suggest a large effect of the intervention on patients' PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Jobst', 'Affiliation': 'Faculty of Medicine, Institute of Nursing Science, University of Freiburg, Fehrenbachallee 8, D-79106 Freiburg, Germany.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Leppla', 'Affiliation': 'Institute of Nursing Science, University of Basel, Bernoullistrasse 28, CH-4056 Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Köberich', 'Affiliation': 'Pflegedirektion, Heart Center University of Freiburg, Hugstetter Straße 55, D-79106 Freiburg, Germany.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00624-y'] 2065,32566262,Tenon Capsule Grafting versus Autologous Scleral Graft in Ahmed Glaucoma Valve Surgery.,"Objective To compare between the surgical outcomes of Tenon capsule grafting and autologous scleral graft in Ahmed glaucoma valve (AGV) surgery in the management of refractory glaucoma and prevention of tube exposure. Patients and Methods . This prospective randomised study included 30 eyes of 30 patients with refractory glaucoma, who were aged between 46 and 58 years and diagnosed with refractory glaucoma. This study was conducted in Menofia University Hospital between July 2018 and December 2019. Informed patient consent was obtained. The studied eyes were divided into two groups: the first group included 15 eyes for which AGV with Tenon capsule grafting was performed, while the second group included 15 eyes for which AGV with autologous scleral graft was performed. All patients were followed up for one year after the surgery. The outcomes were evaluated according to intraocular pressure (IOP) and the number of postoperative glaucoma medications. Visual acuity, visual field, number of postoperative glaucoma medications, and postoperative complications were followed throughout the 1-year follow-up period. Results There was a significant reduction in IOP in both groups, with more reduction in the Tenon graft group where the mean IOP after one year was 11.66 ± 0.89 mmHg, whereas in the scleral graft group, the mean IOP was 14.20 ± 4.0 mmHg ( p value < 0.001). However, the difference between the 2 groups in lowering IOP was insignificant. Regarding postoperative complications, tube exposure was observed in one case in the scleral graft group with associated scleral melting and hypotony, postoperative hypotony was more in the scleral graft group with 3 cases (20%), and in the Tenon graft group, hypotony occurred only in 1 case (6.67%). In addition, less vascular blebs were seen in most cases in the Tenon graft group, while most blebs seen in the scleral graft group were vascular blebs. In addition, both groups showed stability in terms of visual acuity and visual field. Conclusion Tenon capsule grafting and autologous scleral grafting might be effective and safe techniques when applied with AGV in the management of refractory glaucoma. Tenon capsule resection with grafting showed relatively low incidence of tube exposure and hypertensive phase.",2020,"There was a significant reduction in IOP in both groups, with more reduction in the Tenon graft group where the mean IOP after one year was 11.66 ± 0.89 mmHg, whereas in the scleral graft group, the mean IOP was 14.20 ± 4.0 mmHg ( p value < 0.001).","['30 eyes of 30 patients with refractory glaucoma, who were aged between 46 and 58 years and diagnosed with refractory glaucoma', 'Ahmed Glaucoma Valve Surgery', 'Menofia University Hospital between July 2018 and December 2019']","['Tenon Capsule Grafting versus Autologous Scleral Graft', 'autologous scleral grafting', 'AGV with Tenon capsule grafting was performed, while the second group included 15 eyes for which AGV with autologous scleral graft', 'Tenon capsule grafting and autologous scleral graft']","['postoperative complications, tube exposure', 'lowering IOP', 'Visual acuity, visual field, number of postoperative glaucoma medications, and postoperative complications', 'hypotony', 'intraocular pressure (IOP) and the number of postoperative glaucoma medications', 'visual acuity and visual field', 'mean IOP', 'vascular blebs', 'IOP', 'scleral melting and hypotony, postoperative hypotony']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C2586323', 'cui_str': ""Tenon's capsule structure""}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0440756', 'cui_str': 'Scleral graft'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005758', 'cui_str': 'Blister'}]",30.0,0.043184,"There was a significant reduction in IOP in both groups, with more reduction in the Tenon graft group where the mean IOP after one year was 11.66 ± 0.89 mmHg, whereas in the scleral graft group, the mean IOP was 14.20 ± 4.0 mmHg ( p value < 0.001).","[{'ForeName': 'Faried M', 'Initials': 'FM', 'LastName': 'Wagdy', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Shebeen El-Kom, Egypt.'}]",Journal of ophthalmology,['10.1155/2020/1248023'] 2066,32566276,Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study.,"Background Weight regain after laparoscopic sleeve gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short term. We report the results of a randomized study comparing LSG and laparoscopic banded sleeve gastrectomy (LBSG) over a 4-year follow-up. Objectives To evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the midterm. Methods Between 01/2014 and 01/2015, we randomly assigned 50 patients to receive one of the two procedures. Patients' management was exactly the same, apart from the band placement. We analyzed differences in weight loss, operative time, complication rate, and mortality, with a median follow-up of 4 years. Results Twenty five patients were assigned to receive LSG (Group A) and 25 LBSG (Group B). The mean preoperative BMI (body mass index) was 47.3 ± 6.58 kg/m 2 and 45.95 ± 5.85 kg/m 2 , respectively. There was no significant difference in the operative time. No intraoperative or postoperative complications occurred. At 12-month follow-up, the mean BMI was 29.72 ± 4.40 kg/m 2 in Group A and 27.42 ± 4.47 kg/m 2 in Group B ( p =0.186). After a median follow-up of 4 years, the mean BMI in Group B was significantly lower than Group A (24.10 ± 4.52 kg/m 2 vs 28.80 ± 4.62 kg/m 2 ; p =0.00199). Conclusions LBSG is a safe procedure, with no impact on postoperative complications. The banded sleeve showed a significant greater weight loss in the midterm follow-up. Considering the issue of weight regain observed after LSG, the placement of a perigastric ring during the first procedure may be a strategy to improve the results. This trial is registered with NCT04228185.",2020,No intraoperative or postoperative complications occurred.,['Twenty five patients'],"['laparoscopic sleeve gastrectomy (LSG', 'banded sleeve gastrectomy', 'LSG and laparoscopic banded sleeve gastrectomy (LBSG', 'Nonbanded Sleeve', 'Banded Sleeve Gastrectomy', 'LSG']","['intraoperative or postoperative complications', 'weight loss, operative time, complication rate, and mortality, with a median follow-up of 4 years', 'Weight Loss', 'Sleeve dilatation and loss of food restriction', 'mean preoperative BMI (body mass index', 'weight loss', 'operative time', 'mean BMI', 'postoperative complications']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.0494765,No intraoperative or postoperative complications occurred.,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gentileschi', 'Affiliation': 'Department of Surgery, Obesity Unit, Tor Vergata University Hospital, Viale Oxford 81-00133, Rome, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Bianciardi', 'Affiliation': 'Department of Systems Medicine, Tor Vergata University Hospital, Viale Oxford 81-00133, Rome, Italy.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Siragusa', 'Affiliation': 'Department of Surgery, Tor Vergata University Hospital, Viale Oxford 81-00133, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tognoni', 'Affiliation': 'Department of Surgery, Tor Vergata University Hospital, Viale Oxford 81-00133, Rome, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Benavoli', 'Affiliation': 'Department of Surgery, Tor Vergata University Hospital, Viale Oxford 81-00133, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': ""D'Ugo"", 'Affiliation': 'Department of General Surgery, ""Vito Fazzi"" Hospital, Piazza Muratore 1-73100, Lecce, Italy.'}]",Journal of obesity,['10.1155/2020/9792518'] 2067,32566277,"Contribution of Amaranthus cruentus and Solanum macrocarpon Leaves Flour to Nutrient Intake and Effect on Nutritional Status of Rural School Children in Volta Region, Ghana.","Background Plant-based foods are staple diets and main micronutrient sources of most rural Ghanaian households. The objective of this study was to determine the effect of Amaranthus cruentus and Solanum macrocarpon leafy vegetable flour on micronutrient intake and nutritional status of rural Ghanaian school children. Method This study was a randomized controlled trial that consisted of baseline data collection and a three-month nutrition intervention feeding program. Two groups of 53 children, age 4-9 years, involved in the Ghana School Feeding Program took part in the study. An experimental group consumed Amaranthus cruentus and Solanum macrocarpon leaves flour (ACSMLVF) stews and soup. The control group consumed stews and soup without ACSMLVF. Haemoglobin and serum vitamin A concentrations were determined. Dietary and anthropometric data were collected and analysed. Participants were screened for malaria parasitaemia and hookworm. Results Anaemia was present in 41.5% and 37.3%, respectively, of the intervention and control groups at baseline. It was present in 28.3% and 53.3%, respectively, at the end of the study. This was significantly different ( p =0.024). There was a low vitamin A concentration in 66.0% and 64.7% at baseline and 20.8% and 23.4% at the end of the study in the intervention and control groups, respectively. The mean iron, zinc, and provitamin A (beta-carotene) intakes of the intervention group were 14.2 ± 7.1 mg, 5.7 ± 2.1 mg, and 214.5 ± 22.6  μ g, respectively, at baseline. Those of the control were 13.7 ± 6.1 mg, 5.4 ± 2.1 mg, and 210.6 ± 20.1  μ g, respectively. At the end of the study, the mean intake of iron, zinc, and beta-carotene for the intervention group was 24.1 ± 10.9 mg, 13.8 ± 8.2 mg, and 694.2 ± 33.1  μ g, respectively. The intake of these micronutrients for the control at the end of the study was 14.8 ± 6.2 mg, 5.9 ± 2.3 mg, and 418.4 ± 34.7  μ g, respectively. Conclusion Consumption of ACSMLVF stews and soup increased iron, zinc, and beta-carotene intakes. Anaemia prevalence was lower in the intervention group at the end of the study.",2020,"Results Anaemia was present in 41.5% and 37.3%, respectively, of the intervention and control groups at baseline.","['Two groups of 53 children, age 4-9 years, involved in the Ghana School Feeding Program took part in the study', 'Rural School Children in Volta Region, Ghana', 'most rural Ghanaian households', 'rural Ghanaian school children']","['control group consumed stews and soup without ACSMLVF', '\n\n\nPlant-based foods are staple diets']","['Anaemia', 'Haemoglobin and serum vitamin', 'mean iron, zinc, and provitamin A (beta-carotene) intakes', 'Anaemia prevalence', 'malaria parasitaemia and hookworm', 'mean intake of iron, zinc, and beta-carotene', 'iron, zinc, and beta-carotene intakes', 'low vitamin A concentration']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453399', 'cui_str': 'Soup'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0053396', 'cui_str': 'Beta Carotene'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0564437', 'cui_str': 'Beta-carotene intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",53.0,0.0260873,"Results Anaemia was present in 41.5% and 37.3%, respectively, of the intervention and control groups at baseline.","[{'ForeName': 'Godfred', 'Initials': 'G', 'LastName': 'Egbi', 'Affiliation': 'Nutrition Department, Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Glover-Amengor', 'Affiliation': 'Council for Scientific and Industrial Research-Food Research Institute (CSIR-FRI), Accra, Ghana.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Tohouenou', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, P.O. Box LG 134, Legon, Accra 12, Ghana.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Zotor', 'Affiliation': 'School of Public Health, University of Health and Allied Sciences, PMB 31, Ho, Ghana.'}]",Journal of nutrition and metabolism,['10.1155/2020/1015280'] 2068,32566278,Effect of Eel Biscuit Supplementation on Height of Children with Stunting Aged 36-60 Months: A Pilot Study.,"Background Stunting is a major health problem in developing countries. Animal-based supplements can increase the height of children with stunting. This study was aimed at determining the effect of eel biscuit supplementation on increase in the height of children with stunting aged 36-60 months. Methods A pilot study with pretest-post-test design. The study was conducted in two villages in the Priangan Region, West Java Province, Indonesia. The participants were divided into two groups: intervention group (10 supplemented eel biscuit pieces) and control group (biscuits from the government's biscuit programme). A total of 56 children aged 36-60 months with the height-for-age z -score of <-2 SD were recruited voluntarily for sampling. Results The initial height-for-age z -score of the intervention group was -3.45 SD and that of the control group was -3.11 SD. After 3 months of supplemented eel biscuit consumption, the height-for-age z -score of the intervention group changed to -2.52 SD and that of the control group changed to -2.51 SD. The average shift of the height-for-age z -score after 3 months of supplemented eel biscuit consumption was 0.93 SD in the intervention group and 0.6 SD in the control group. There were significant differences in delta and percent increase in the height-for-age z -score between both groups. Conclusions Consumption of supplemented eel biscuits for 3 months increased the height-for-age z -score of children with stunting aged 36-60 months by 0.93 SD.",2020,"There were significant differences in delta and percent increase in the height-for-age z -score between both groups. ","['Children with Stunting Aged 36-60 Months', 'children with stunting', 'children with stunting aged 36-60 months', '56 children aged 36-60 months with the height-for-age z -score of\u2009<-2 SD were recruited voluntarily for sampling', 'two villages in the Priangan Region, West Java Province, Indonesia']","['eel biscuit supplementation', 'Eel Biscuit Supplementation', ""intervention group (10 supplemented eel biscuit pieces) and control group (biscuits from the government's biscuit programme""]",['height-for-age z -score'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0205803', 'cui_str': 'Java'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0013671', 'cui_str': 'Eel'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",56.0,0.035139,"There were significant differences in delta and percent increase in the height-for-age z -score between both groups. ","[{'ForeName': 'Dewi M D', 'Initials': 'DMD', 'LastName': 'Herawati', 'Affiliation': 'Department of Public Health, Division of Medical Nutrition, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Siti N', 'Initials': 'SN', 'LastName': 'Asiyah', 'Affiliation': 'Magister of Public Health Programme, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Siska', 'Initials': 'S', 'LastName': 'Wiramihardja', 'Affiliation': 'Department of Public Health, Division of Medical Nutrition, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Shifa', 'Initials': 'S', 'LastName': 'Fauzia', 'Affiliation': 'Magister of Basic Medical Science Programme, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Deni K', 'Initials': 'DK', 'LastName': 'Sunjaya', 'Affiliation': 'Magister of Public Health Programme, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}]",Journal of nutrition and metabolism,['10.1155/2020/2984728'] 2069,32566281,Acute Effect of a Protein Supplement on Targeted Plasma Amino Acid Profile among Healthy Asian Indians: A Randomized Controlled Trial.,"Background Indians have a poor protein intake in terms of quantity as well as quality because of their predominantly cereal-based diet. However, there is limited information on circulatory amino acid levels in healthy Indians. Herein, we evaluated the acute effect of a protein supplement on the plasma levels of essential amino acids (EAAs) in healthy Indian adults, using targeted EAA analysis. Methods In this double-blind, randomized, crossover study, 20 healthy Indian adults were randomized to receive the test protein supplement (treatment arm, n  = 10) or placebo (control arm, n  = 10) with milk, after overnight fasting. After 7 days, the participants returned for the crossover treatment. Blood samples were collected at baseline and at 60 and 120 min after protein/placebo consumption. Plasma EAA levels were estimated using liquid chromatography-tandem mass spectrometry. Repeated measures ANOVA was performed to assess the effect of treatment on EAA levels. P values < 0.05 were considered statistically significant. Results At baseline, mean plasma levels did not differ significantly between the two arms for any of the EAAs. In the treatment arm, the mean levels of all EAAs increased significantly from baseline to 60 min ( P < 0.01), with no significant change from 60 to 120 min. There was no significant change in amino acid levels in the control arm. The magnitude as well as percentage of increase from baseline to 60 min was significantly greater in the treatment arm than in the control arm for all EAAs. Conclusion Compared to placebo, protein supplement increased circulatory amino acid levels in healthy Indians. The observed increase in EAA levels and its role in conjunction with exercise in both healthy and diseased states need to be further evaluated. This is the first dataset exploring targeted EAA profiles and the effect of a protein supplement among healthy Indians. The clinical trial is registered with CTRI/2018/12/016777.",2020,"In the treatment arm, the mean levels of all EAAs increased significantly from baseline to 60 min ( P < 0.01), with no significant change from 60 to 120 min.","['healthy Indians', '20 healthy Indian adults', 'Healthy Asian Indians', 'healthy Indian adults']","['test protein supplement (treatment arm, n \u2009=\u200910) or placebo (control arm, n \u2009=\u200910) with milk, after overnight fasting', 'protein supplement', 'placebo, protein supplement', 'Protein Supplement']","['circulatory amino acid levels', 'Plasma EAA levels', 'Blood samples', 'EAA levels', 'mean plasma levels', 'amino acid levels', 'mean levels of all EAAs', 'plasma levels of essential amino acids (EAAs']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1524069', 'cui_str': 'Indian'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0243046', 'cui_str': 'Excitatory Amino Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}]",20.0,0.190198,"In the treatment arm, the mean levels of all EAAs increased significantly from baseline to 60 min ( P < 0.01), with no significant change from 60 to 120 min.","[{'ForeName': 'Ammu', 'Initials': 'A', 'LastName': 'Kurien', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Madhavi', 'Initials': 'M', 'LastName': 'Marathe', 'Affiliation': 'Health Care Nutrition Science & Medical Affairs, Nutricia International Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Nandan', 'Initials': 'N', 'LastName': 'Joshi', 'Affiliation': 'Health Care Nutrition Science & Medical Affairs, Nutricia International Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Sumithra', 'Initials': 'S', 'LastName': 'Selvam', 'Affiliation': ""Division of Epidemiology, Biostatistics and Population Health, St. John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Devi', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Sucharita', 'Initials': 'S', 'LastName': 'Sambashivaiah', 'Affiliation': ""Department of Physiology, St. John's Medical College, Bengaluru, India.""}]",Journal of nutrition and metabolism,['10.1155/2020/8946820'] 2070,32566371,THE EFFECT OF A RHYTHMIC GYMNASTICS-BASED POWER-FLEXIBILITY PROGRAM ON THE LOWER LIMB FLEXIBILITY AND POWER OF CONTEMPORARY DANCERS.,"Background There is an increasing cross-fertilization between the movements in contemporary dance and aesthetic sports such as rhythmic gymnastics. In such sports, supplementary training is commonly used to enable athletes to achieve all of their training goals, however dancers typically do not engage in cross training from other disciplines. Purpose The aim of this research was to test the effectiveness of a rhythmic gymnastics-based supplementary training program on lower limb flexibility and power of contemporary dancers. Study Design Experimental study using a between-groups design. Setting Training Intervention: Prahran Rhythmic Gymnastics Specialist Centre, Testing: Deakin University. Methods Eleven female contemporary dancers were randomly assigned to either a control or intervention group. The intervention group (n = 6) participated in an eight-week rhythmic gymnastics-based supplementary training program comprising two one-hour sessions per week in addition to their usual training. The control group (n = 5) continued their usual dance training. Pre and post measures of range of motion (ROM) and power were taken via a dance-specific kick test using an isokinetic dynamometer and a customized grand jeté test in a 3D-motion laboratory. Results Significant increases in right and left leg grand jeté ROM, right leg peak kicking torque and left leg grand jeté height were recorded in the intervention compared to the control group. Conclusion The results of the study suggest that rhythmic gymnastics training could provide a viable means for contemporary dancers to target active ROM and power of explosive dance movements. Future research should include subjective evaluations of dance performers to confirm that training adaptions are transferred to improvements in performance quality. Level of Evidence III.",2020,"Pre and post measures of range of motion (ROM) and power were taken via a dance-specific kick test using an isokinetic dynamometer and a customized grand jeté test in a 3D-motion laboratory. ",['Methods\n\n\nEleven female contemporary dancers'],"['Setting\n\n\nTraining Intervention', 'usual dance training', 'rhythmic gymnastics training', 'rhythmic gymnastics-based supplementary training program']","['lower limb flexibility and power of contemporary dancers', 'right and left leg grand jeté ROM, right leg peak kicking torque and left leg grand jeté height', 'range of motion (ROM']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}]","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",6.0,0.0156697,"Pre and post measures of range of motion (ROM) and power were taken via a dance-specific kick test using an isokinetic dynamometer and a customized grand jeté test in a 3D-motion laboratory. ","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Skopal', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Netto', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Aisbett', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Takla', 'Affiliation': ''}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Castricum', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}]",International journal of sports physical therapy,[] 2071,32566513,Comparison of conventional and Hang-back methods of inferior oblique recession in V-pattern strabismus with inferior oblique overaction.,"AIM To compare outcomes of conventional and Hang-back methods of inferior oblique (IO) recession in V-pattern strabismus with inferior oblique overaction (IOOA). METHODS Comparative randomized study was conducted consisting of 50 patients, age 6 to 35y having V-pattern strabismus [>15 prism diopter (PD)] with IOOA. They were divided equally in two groups and underwent IO recession, group A by conventional method and group B by Hang-back method. Parameters evaluated were reduction in V-pattern and IOOA, shift in torsion, improvement in binocular status. Success was a residual V-pattern of less than 10 PD at 1y of follow up. RESULTS The mean V-pattern preoperatively and postoperatively at 1y was 24±5.4 PD and 4.2±3.51 PD in group A and 23.44±6.44 PD and 5.76±3.8 PD in group B respectively. The mean reduction in V-pattern was 20±6.78 PD in group A and 18.2±5.48 PD in group B. The mean correction of IOOA was 18.48±3.13 PD in group A and 16±2.93 PD in group B. Mean shift in extorsion was 3.08±1.8 degree in group A and 3.72±2.14 degree in group B. CONCLUSION Both the procedures achieve a significant and comparable reduction in V-pattern and IOOA. Hang-back recession being a landmark free surgery eliminates the need for intrascleral suturing thereby reducing the risk of scleral perforation with possible postoperative adjustment of muscle. It may be considered as a good alternative for IO recession in patients of V-pattern strabismus with mild to moderate amount of IOOA.",2020,The mean reduction in V-pattern was 20±6.78 PD in group A and 18.2±5.48 PD in group B.,"['V-pattern strabismus with inferior oblique overaction', '50 patients, age 6 to 35y having V-pattern strabismus']","['conventional and Hang-back methods of inferior oblique recession', 'IO recession, group A by conventional method and group B by Hang-back method', 'conventional and Hang-back methods of inferior oblique (IO) recession in V-pattern strabismus with inferior oblique overaction (IOOA']","['reduction in V-pattern and IOOA, shift in torsion, improvement in binocular status', 'B. Mean shift in extorsion', 'mean reduction in V-pattern', 'mean correction of IOOA']","[{'cui': 'C1532707', 'cui_str': 'V-pattern strabismus'}, {'cui': 'C1276001', 'cui_str': 'Inferior oblique overaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0395355', 'cui_str': 'Inferior oblique recession'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0582817', 'cui_str': 'Inferior oblique muscle structure'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C1532707', 'cui_str': 'V-pattern strabismus'}, {'cui': 'C1276001', 'cui_str': 'Inferior oblique overaction'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1276001', 'cui_str': 'Inferior oblique overaction'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0177223,The mean reduction in V-pattern was 20±6.78 PD in group A and 18.2±5.48 PD in group B.,"[{'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Anand', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Dhiman', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Yashpal', 'Initials': 'Y', 'LastName': 'Goel', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Mishra', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002, India.'}]",International journal of ophthalmology,['10.18240/ijo.2020.06.20'] 2072,32566597,"Erratum to efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial.",[This corrects the article DOI: 10.21037/atm.2019.07.95.].,2020,[This corrects the article DOI: 10.21037/atm.2019.07.95.].,['patients with breast cancer'],"['mecapegfilgrastim', 'chemotherapy-induced neutropenia']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3179328', 'cui_str': 'pegylated granulocyte colony-stimulating factor'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}]",[],,0.0210156,[This corrects the article DOI: 10.21037/atm.2019.07.95.].,"[{'ForeName': 'Fengrui', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Xinxiang University, Xinxiang 453100, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Breast Surgery, Hongqing Cancer Hospital, Chongqing 400030, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, Sichuan Province People's Hospital, Chengdu 610072, China.""}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Zhongshan University Cancer Center, Guangzhou 510060, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Breast Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.'}, {'ForeName': 'Zhiyue', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Research and Development, Jiangsu Hengrui Medicine Co., Ltd., Shanghai 200120, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Research and Development, Jiangsu Hengrui Medicine Co., Ltd., Shanghai 200120, China.'}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China.'}]",Annals of translational medicine,['10.21037/atm-2020-23'] 2073,32566685,"Effects of Exenatide and Humalog Mix25 on Fat Distribution, Insulin Sensitivity, and β -Cell Function in Normal BMI Patients with Type 2 Diabetes and Visceral Adiposity.","In China, most normal BMI (body mass index of ≥18.5 to <25 kg/m 2 ) adults with type 2 diabetes (T2DM) exhibit visceral adiposity. This study compared the effects of exenatide and humalog Mix25 on normal BMI patients with T2DM and visceral adiposity. A total of 95 patients were randomized to receive either exenatide or humalog Mix25 treatment for 24 weeks. Subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) were quantified by magnetic resonance imaging (MRI) and liver fat content (LFC) by liver proton magnetic resonance spectroscopy ( 1 H MRS). Each patient's weight, waist circumference, BMI, blood glucose, insulin sensitivity, pancreatic β -cell function, and fibroblast growth factor 21 (FGF-21) levels were measured. Data from 81 patients who completed the study (40 and 41 in the exenatide and humalog Mix25 groups, respectively) were analysed. The change in 2 h plasma blood glucose was greater in the exenatide group ( P = 0.039). HOMA-IR and MBCI improved significantly after exenatide therapy ( P < 0.01, P = 0.045). VAT and LFC decreased in both groups ( P < 0.01 for all) but to a greater extent in the exenatide group, while SAT only decreased with exenatide therapy ( P < 0.01). FGF-21 levels declined more in the exenatide group ( P < 0.01), but were positively correlated with VAT in the entire cohort before ( r = 0.244, P = 0.043) and after ( r = 0.290, P = 0.016) the intervention. The effects of exenatide on glycaemic metabolism, insulin resistance, pancreatic β -cell function, and fat deposition support its administration to normal BMI patients with T2DM and visceral adiposity.",2020,"VAT and LFC decreased in both groups ( P < 0.01 for all) but to a greater extent in the exenatide group, while SAT only decreased with exenatide therapy ( P < 0.01).","['95 patients', '81 patients who completed the study (40 and 41 in the exenatide and humalog Mix25 groups, respectively) were analysed', 'Normal BMI Patients with Type 2 Diabetes and Visceral Adiposity', 'normal BMI patients with T2DM and visceral adiposity']","['exenatide or humalog', 'exenatide', 'magnetic resonance imaging (MRI) and liver fat content (LFC) by liver proton magnetic resonance spectroscopy', 'exenatide and humalog Mix25', 'Exenatide and Humalog Mix25']","['Subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT', 'Fat Distribution, Insulin Sensitivity, and β -Cell Function', 'HOMA-IR and MBCI', 'change in 2\u2009h plasma blood glucose', 'glycaemic metabolism, insulin resistance, pancreatic β -cell function, and fat deposition', 'weight, waist circumference, BMI, blood glucose, insulin sensitivity, pancreatic β -cell function, and fibroblast growth factor 21 (FGF-21) levels', 'FGF-21 levels', 'VAT and LFC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0733228', 'cui_str': 'Humalog Mix25'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0733228', 'cui_str': 'Humalog Mix25'}]","[{'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",95.0,0.0203391,"VAT and LFC decreased in both groups ( P < 0.01 for all) but to a greater extent in the exenatide group, while SAT only decreased with exenatide therapy ( P < 0.01).","[{'ForeName': 'Xinlei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Yunjuan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Yin', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Zhuqi', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'OuYang', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Ranran', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}, {'ForeName': 'Shiwei', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Nantong University, Nantong 226001, China.'}]",Journal of diabetes research,['10.1155/2020/9783859'] 2074,32566737,"Development of an interactive e-learning software ""Histologie für Mediziner"" for medical histology courses and its overall impact on learning outcomes and motivation.","Objective: To develop and evaluate an interactive histology learning software for medical students in the preclinical study phase. The educational design of the software was based on current learning theory models, such as the Cognitive load theory, Cognitive theory of multimedia learning , and the ARCS model, so that the acquired knowledge can be repeated using a diversified design. Moreover, the learning effects achieved by using the software shall be evaluated. Apart from the software's usability, the influence of the learning theory principles on the students' motivation shall be assessed. Methodology: The software was evaluated using an experimental wait list control group with a pre-/post-test design (n=213). Depending on the group they were assigned to, students learned the histology contents of chapter ""Liver, gall bladder, pancreas"" using the traditional program of the Goethe University (n=65), the new interactive software (n=56), or without any of the two software versions (n=92). The influence of the different learning aids on the acquisition of knowledge was assessed with three questionnaires comprising four different multiple choice questions each. For the evaluation of the usability and motivational factors, a second test was added to the questionnaire of both software versions. Results: The interactive software was rated significantly better with regard to usability and motivational aspects than the traditional learning program ( F (7, 113)=12.48, p <.001, partial η 2 =.436). Moreover, use of the interactive software resulted in a significant increase of knowledge acquisition as compared to the group of students who had learned without any of the two software versions (0.77, p =.001). Conclusion: With regard to the histology contents, usability was comparable to the official learning program. Interactive elements and the educational design contributed to an increase of the factors that are essential for intrinsic motivation. Thus, our program can be valuable tool to supplement the curriculum as an additional service.",2020,"Results: The interactive software was rated significantly better with regard to usability and motivational aspects than the traditional learning program ( F (7, 113)=12.48, p <.001, partial η 2 =.436).",['medical students'],"['interactive histology learning software', 'students learned the histology contents of chapter ""Liver, gall bladder, pancreas"" using the traditional program of the Goethe University (n=65), the new interactive software']","['knowledge acquisition', 'usability and motivational aspects']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",,0.015395,"Results: The interactive software was rated significantly better with regard to usability and motivational aspects than the traditional learning program ( F (7, 113)=12.48, p <.001, partial η 2 =.436).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Drees', 'Affiliation': 'Goethe University Frankfurt/Main, Dr. Senckenbergische Anatomie, Anatomy I, Clinical Neuroanatomy, Frankfurt/Main, Germany.'}, {'ForeName': 'Estifanos', 'Initials': 'E', 'LastName': 'Ghebremedhin', 'Affiliation': 'Goethe University Frankfurt/Main, Dr. Senckenbergische Anatomie, Anatomy I, Clinical Neuroanatomy, Frankfurt/Main, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Goethe University Frankfurt/Main, Educational Psychology, Interdisciplinary College for University Teaching (IKH), Frankfurt/Main, Germany.'}]",GMS journal for medical education,['10.3205/zma001328'] 2075,32566758,"The impact of the Trauma Triage App on pre-hospital trauma triage: design and protocol of the stepped-wedge, cluster-randomized TESLA trial.","Background Field triage of trauma patients is crucial to get the right patient to the right hospital within a particular time frame. Minimization of undertriage, overtriage, and interhospital transfer rates could substantially reduce mortality rates, life-long disabilities, and costs. Identification of patients in need of specialized trauma care is predominantly based on the judgment of Emergency Medical Services professionals and a pre-hospital triage protocol. The Trauma Triage App is a smartphone application that includes a prediction model to aid Emergency Medical Services professionals in the identification of patients in need of specialized trauma care. The aim of this trial is to assess the impact of this new digital approach to field triage on the primary endpoint undertriage. Methods The Trauma triage using Supervised Learning Algorithms (TESLA) trial is a stepped-wedge cluster-randomized controlled trial with eight clusters defined as Emergency Medical Services regions. These clusters are an integral part of five inclusive trauma regions. Injured patients, evaluated on-scene by an Emergency Medical Services professional, suspected of moderate to severe injuries, will be assessed for eligibility. This unidirectional crossover trial will start with a baseline period in which the default pre-hospital triage protocol is used, after which all clusters gradually implement the Trauma Triage App as an add-on to the existing triage protocol. The primary endpoint is undertriage on patient and cluster level and is defined as the transportation of a severely injured patient (Injury Severity Score ≥ 16) to a lower-level trauma center. Secondary endpoints include overtriage, hospital resource use, and a cost-utility analysis. Discussion The TESLA trial will assess the impact of the Trauma Triage App in clinical practice. This novel approach to field triage will give new and previously undiscovered insights into several isolated components of the diagnostic strategy to get the right trauma patient to the right hospital. The stepped-wedge design allows for within and between cluster comparisons. Trial registration Netherlands Trial Register, NTR7243. Registered 30 May 2018, https://www.trialregister.nl/trial/7038.",2020,The Trauma Triage App is a smartphone application that includes a prediction model to aid Emergency Medical Services professionals in the identification of patients in need of specialized trauma care.,"['trauma patients', 'Injured patients, evaluated on-scene by an Emergency Medical Services professional, suspected of moderate to severe injuries']",[],"['undertriage on patient and cluster level and is defined as the transportation of a severely injured patient (Injury Severity Score ≥ 16) to a lower-level trauma center', 'mortality rates, life-long disabilities, and costs', 'overtriage, hospital resource use, and a cost-utility analysis']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}]",,0.109281,The Trauma Triage App is a smartphone application that includes a prediction model to aid Emergency Medical Services professionals in the identification of patients in need of specialized trauma care.,"[{'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'van der Sluijs', 'Affiliation': 'Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Audrey A A', 'Initials': 'AAA', 'LastName': 'Fiddelers', 'Affiliation': 'Network Acute Care Limburg, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Job F', 'Initials': 'JF', 'LastName': 'Waalwijk', 'Affiliation': 'Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Reitsma', 'Affiliation': 'Department of Epidemiology, Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Miranda J', 'Initials': 'MJ', 'LastName': 'Dirx', 'Affiliation': 'Network Acute Care Limburg, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'den Hartog', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Silvia M A A', 'Initials': 'SMAA', 'LastName': 'Evers', 'Affiliation': 'Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'W Margreet', 'Initials': 'WM', 'LastName': 'Hoogeveen', 'Affiliation': 'Ambulance Care the Netherlands, Zwolle, The Netherlands.'}, {'ForeName': 'Koen W', 'Initials': 'KW', 'LastName': 'Lansink', 'Affiliation': 'Department of Surgery, Elisabeth TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Luke P H', 'Initials': 'LPH', 'LastName': 'Leenen', 'Affiliation': 'Department of Surgery, Utrecht University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Heijl', 'Affiliation': 'Department of Surgery, Utrecht University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Poeze', 'Affiliation': 'Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Diagnostic and prognostic research,['10.1186/s41512-020-00076-1'] 2076,32567051,The effect of internet-based guided self-help cognitive-behavioral therapies on Iranian women's psychological symptoms and preferred method of childbirth.,"PURPOSE The effectiveness of an Internet-based guided self-help cognitive-behavioral therapy (I-GSH-CBT) was assessed in alleviating childbirth fear (CBF), depression, anxiety, and stress of pregnant women during the first delivery. DESIGN AND METHODS In a quasi-experimental study, pregnant women in the intervention group used the I-GSH-CBT program during pregnancy. The Wijma Delivery Expectancy/Experience Questionnaire, and the Depression, Anxiety, and Stress Scale 42-item (DASS-42) questionnaires were used to collect the psychometric data. FINDINGS Implementing the I-GSH-CBT significantly reduced CBF, DASS-42 scores, and cesarean section preference. PRACTICE IMPLICATIONS The I-GSH-CBT program effectively decreases the adverse mood symptoms in nulliparous pregnant women.",2020,"FINDINGS Implementing the I-GSH-CBT significantly reduced CBF, DASS-42 scores, and cesarean section preference. ","['pregnant women during the first delivery', 'nulliparous pregnant women', ""Iranian women's psychological symptoms and preferred method of childbirth""]","['Internet-based guided self-help cognitive-behavioral therapy (I-GSH-CBT', 'I-GSH-CBT program', 'internet-based guided self-help cognitive-behavioral therapies']","['adverse mood symptoms', 'alleviating childbirth fear (CBF), depression, anxiety, and stress', 'Wijma Delivery Expectancy/Experience Questionnaire, and the Depression, Anxiety, and Stress Scale 42-item (DASS-42) questionnaires', 'CBF, DASS-42 scores, and cesarean section preference']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",,0.0197105,"FINDINGS Implementing the I-GSH-CBT significantly reduced CBF, DASS-42 scores, and cesarean section preference. ","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shahsavan', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Banafsheh', 'Initials': 'B', 'LastName': 'Gharraee', 'Affiliation': 'Department of Clinical Psychology, School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry), Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Abolghasemi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Khedmat', 'Affiliation': 'Health Management Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}]",Perspectives in psychiatric care,['10.1111/ppc.12535'] 2077,32567065,"Effectiveness of WeChat-based Smoking Cessation intervention (""WeChat WeQuit"" program) in China: study protocol for a randomized controlled trial.","BACKGROUND AND AIMS Since its first release in 2011, WeChat (Chinese pinyin: Wei Xin) has been widely used to promote health. As the most popular all-in-one social media app providing free instant messaging, voice, text, pictures, videos and location information exchange via smartphone, WeChat holds promise for delivering smoking cessation services to a large number of people at low unit cost in China, a country with more than 300 million smokers. This protocol is for a study that aims to assess the efficacy of a WeChat-based smoking cessation intervention (""WeChat WeQuit"") for treatment seeking smokers in China. DESIGN In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of ""Happy Quit"". The intervention group will also receive the 2 weeks pre- and 12 weeks post-quit ""WeChat WeQuit"" intervention. Both groups will be followed up to 26 weeks (6 months) after quit day. SETTING This online trial has no restrictions on setting or location. PARTICIPANTS Chinese-speaking current smokers (smoked ≥ 100 cigarettes in the lifetime and currently smokes cigarettes) aged 18+, willing to make a quit attempt within 1 month (n = 2000) will be recruited by on-line and off-line advertising. Potential participants will register their interest by sending WeChat messages or text messages, or making a voice call. MEASUREMENTS The primary outcome measure is self-reported 26-week continuous smoking abstinence with biological verification (test by clinic visit: expired carbon monoxide concentration < 10 ppm or by mailing cotinine urine dipsticks: urine cotinine < 200 ng/ml). Secondary outcome measures include: 7-day point prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after-quit day; self-reported 12-week continuous smoking abstinence and 26-week continuous smoking abstinence; reductions in number of cigarettes smoked per day; and rates of participation in and completion of smoking-cessation program. COMMENTS If the ""WeChat WeQuit"" program is found to be effective, it will be an accessible, affordable and widely implementable intervention to help cigarette smokers to quit. The potential public health impact of its expansion into underserved regions or communities is considerable.",2020,"In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of ""Happy Quit"".","['Chinese-speaking current smokers (smoked ≥ 100 cigarettes in the lifetime and currently smokes cigarettes) aged 18+, willing to make a quit attempt within 1 month (n = 2000) will be recruited by on-line and off-line advertising', 'treatment seeking smokers in China']","['WeChat-based smoking cessation intervention (""WeChat WeQuit', 'WeChat-based Smoking Cessation intervention (""WeChat WeQuit"" program']","[' 7-day point prevalence abstinence', 'continuous smoking abstinence and 26-week continuous smoking abstinence; reductions in number of cigarettes smoked per day; and rates of participation in and completion of smoking-cessation program', 'self-reported 26-week continuous smoking abstinence with biological verification (test by clinic visit: expired carbon monoxide concentration < 10 ppm or by mailing cotinine urine dipsticks: urine cotinine < 200 ng/ml']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",,0.0682711,"In this two-arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of ""Happy Quit"".","[{'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yueheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}]","Addiction (Abingdon, England)",['10.1111/add.15166'] 2078,32567103,Telephone-guided imagery rehearsal therapy for nightmares: Efficacy and mediator of change.,"The currently best-supported psychological treatment for nightmares is imagery rehearsal therapy. The problem, however, is that not enough trained practitioners are available to offer this treatment. A possible solution is to conduct imagery rehearsal therapy in a guided self-help format. In the current study, 70 participants with nightmares according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders were randomized to either telephone-guided imagery rehearsal therapy (n = 36) or a wait-list condition (n = 34). Participants in the imagery rehearsal therapy condition received three sessions over the course of 5 weeks. Every treatment session was followed by telephone support delivered by postgraduate students. Participants who received imagery rehearsal therapy showed larger improvements on nightmare frequency (d = 1.03; p < .05), nightmare distress (d = 0.75; p < .05) and insomnia severity (d = 1.12; p < .001) compared with the participants in the wait-list condition. The effects were sustained at 3- and 6-month follow-up. No significant effects were observed on the number of nights with nightmares per week, anxiety and depression. In line with earlier reports, the treatment effect was mediated by the increase of mastery at mid-treatment, underlining the mechanistic value of mastery in imagery rehearsal therapy. The present study demonstrates that it is possible to deliver imagery rehearsal therapy in a self-help format supported by unexperienced therapists and with relatively little time investment. This opens possibilities in terms of cost-effectiveness, scalability and dissemination of imagery rehearsal therapy in the treatment of nightmares.",2020,"Participants who received imagery rehearsal therapy showed larger improvements on nightmare frequency (d = 1.03; p < .05), nightmare distress (d = 0.75; p < .05) and insomnia severity (d = 1.12; p < .001) compared with the participants in the wait-list condition.","['nightmares', '70 participants with nightmares according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders']","['telephone-guided imagery rehearsal therapy (n\xa0=\xa036) or a wait-list condition', 'imagery rehearsal therapy', 'Telephone-guided imagery rehearsal therapy']","['nightmare frequency', 'insomnia severity', 'nightmare distress', 'number of nights with nightmares per week, anxiety and depression']","[{'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",70.0,0.0136442,"Participants who received imagery rehearsal therapy showed larger improvements on nightmare frequency (d = 1.03; p < .05), nightmare distress (d = 0.75; p < .05) and insomnia severity (d = 1.12; p < .001) compared with the participants in the wait-list condition.","[{'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Lancee', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Effting', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kunze', 'Affiliation': 'Department of Psychology, LMU Munich, Munich, Germany.'}]",Journal of sleep research,['10.1111/jsr.13123'] 2079,32567116,Over the limit? Testing non-linear associations between alcohol outlets and young adults' alcohol consumption.,"INTRODUCTION AND AIMS By specifying a threshold at which the number of liquor licences has the most impact on local populations, authorities can work to restrict licence approvals and help prevent alcohol-related harm. DESIGN AND METHODS Raine Study Generation 2 participants reported their alcohol intake at 22 years (n = 843) and liquor licences within 1600 m of participants' homes were mapped. Analyses examined associations between licences (all licences, on-premise licences, liquor stores) and alcohol intake (g ethanol per day). Two models were fitted: (i) forced a straight-line relationship; and (ii) allowed a curved relationship via restricted cubic splines. RESULTS The straight-line and curved models showed significant relationships with all licences (P = 0.002 and P = 0.002 respectively) and on-premise licences (P = 0.006 and P = 0.01 respectively), but not liquor stores (P = 0.065 and P = 0.13 respectively). The straight-line model indicated that alcohol consumption increased, on average, by 0.15 g per day for each additional licence and 0.17 g per day for each additional on-premise licence. The curved model indicated that consumption increased by around 0.4 g per day for each additional licence from 0 to 10, but increases were negligible for additional licences beyond 10. The curved model provided a better overall fit to the data than the straight-line model (R 2 9.52% vs. 9.18%), but the improvement in fit did not quite reach statistical significance (P = 0.08). The curvature was similar, but less pronounced for on-premise licences (R 2 9.11% vs. 8.95%; P = 0.23). DISCUSSION AND CONCLUSIONS Results suggest a possible saturation point at which additional licences have a smaller effect on the alcohol intake of 22-year-olds living in metropolitan Perth.",2020,"The curved model provided a better overall fit to the data than the straight-line model (R 2 9.52% vs. 9.18%), but the improvement in fit did not quite reach statistical significance (P = 0.08).","['22-year-olds living in metropolitan Perth', ""Raine Study Generation 2 participants reported their alcohol intake at 22\u2009years (n = 843) and liquor licences within 1600\u2009m of participants' homes were mapped""]",[],"['alcohol consumption', 'liquor stores', 'licences (all licences, on-premise licences, liquor stores) and alcohol intake']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}, {'cui': 'C1698986', 'cui_str': 'Storage'}]",2.0,0.0187424,"The curved model provided a better overall fit to the data than the straight-line model (R 2 9.52% vs. 9.18%), but the improvement in fit did not quite reach statistical significance (P = 0.08).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Foster', 'Affiliation': 'Centre for Urban Research, School of Global, Urban and Social Studies, RMIT University, Melbourne, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Hooper', 'Affiliation': 'Australian Urban Design Research Centre, School of Design, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Divitini', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Knuiman', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Trapp', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Australia.'}]",Drug and alcohol review,['10.1111/dar.13115'] 2080,32564674,Knowledge of results during vertical jump testing: an effective method to increase the performance but not the consistency of vertical jumps.,"This study aimed to determine whether the provision of jump height feedback (knowledge of result; KR) can increase the performance and the consistency of output variables. In a randomised order, sixteen participants performed six squat or countermovement jumps (three from a 90º knee angle and three from a self-preferred knee angle) with or without KR over four sessions. The provision of KR significantly increased peak force ( p  = 0.046, 1.83%), mean force ( p  = 0.037, 1.45%), peak velocity ( p  < 0.001, 3.71%), mean velocity ( p  = 0.004, 3.44%), peak power ( p  < 0.001, 4.22%) and mean power ( p  = 0.001, 4.69%). A high within-session reliability was observed for all variables (coefficient of variation [CV] ≤ 5.62%, intraclass correlation coefficient [ICC] ≥ 0.95). No systematic differences in reliability were detected between the jumps performed without KR (CV = 3.00 ± 1.38%, ICC = 0.97 ± 0.03) and with KR (CV = 3.04 ± 1.49%, ICC = 0.97 ± 0.04). These results suggest that the provision of jump height feedback during vertical jump testing is effective to enhance vertical jump performance but it does not reduce the variability between jumps.",2020,"The provision of KR significantly increased peak force ( p  = 0.046, 1.83%), mean force ( p  = 0.037, 1.45%), peak velocity ( p  < 0.001, 3.71%), mean velocity ( p  = 0.004, 3.44%), peak power ( p  < 0.001, 4.22%) and mean power ( p  = 0.001, 4.69%).",[],"['six squat or countermovement jumps', 'jump height feedback (knowledge of result; KR']","['peak velocity', 'reliability', 'peak force', 'mean force', 'mean velocity', 'peak power']",[],"[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0022754', 'cui_str': 'Knowledge of Results (Psychology)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",16.0,0.0445296,"The provision of KR significantly increased peak force ( p  = 0.046, 1.83%), mean force ( p  = 0.037, 1.45%), peak velocity ( p  < 0.001, 3.71%), mean velocity ( p  = 0.004, 3.44%), peak power ( p  < 0.001, 4.22%) and mean power ( p  = 0.001, 4.69%).","[{'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': 'Faculty of Sport and Physical Education, the Research Centre, University of Belgrade , Belgrade, Serbia.'}, {'ForeName': 'Juande', 'Initials': 'J', 'LastName': 'Cobo-Font', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Marcos-Frutos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'John F T', 'Initials': 'JFT', 'LastName': 'Fernandes', 'Affiliation': 'Sport, Exercise and Well-being Arena, Hartpury University , Hartpury, UK.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Taube', 'Affiliation': 'Department of Neurosciences and Movement Sciences, University of Fribourg , Fribourg, Switzerland.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada , Granada, Spain.'}]",Sports biomechanics,['10.1080/14763141.2020.1764090'] 2081,32564705,The microbial biofilm composition on peripherally inserted central catheters: A comparison of polyurethane and hydrophobic catheters collected from paediatric patients.,"BACKGROUND Peripherally inserted central catheters are susceptible to microbial colonisation and subsequent biofilm formation, leading to central line-associated bloodstream infection, a serious peripherally inserted central catheter-related complication. Next-generation peripherally inserted central catheter biomaterials, such as hydrophobic materials (e.g. Endexo ® ), may reduce microbial biofilm formation or attachment, consequently reducing the potential for central line-associated bloodstream infection. METHODS Within a randomised controlled trial, culture-dependent and culture-independent methods were used to determine if the biomaterials used in traditional polyurethane peripherally inserted central catheters and hydrophobic peripherally inserted central catheters impacted microbial biofilm composition. This study also explored the impact of other clinical characteristics including central line-associated bloodstream infection, antibiotic therapy and dwell time on the microbial biofilm composition of peripherally inserted central catheters. RESULTS From a total of 32 patients, one peripherally inserted central catheter was determined to be colonised with Staphylococcus aureus , and on further analysis, the patient was diagnosed with central line-associated bloodstream infection. All peripherally inserted central catheters ( n = 17 polyurethane vs n = 15 hydrophobic) were populated with complex microbial communities, including peripherally inserted central catheters considered non-colonised. The two main microbial communities observed included Staphylococcus spp., dominant on the colonised peripherally inserted central catheter, and Enterococcus , dominant on non-colonised peripherally inserted central catheters. Both the peripherally inserted central catheter biomaterial design and antibiotic therapy had no significant impact on microbial communities. However, the diversity of microbial communities significantly decreased with dwell time. CONCLUSION More diverse pathogens were present on the colonised peripherally inserted central catheter collected from the patient with central line-associated bloodstream infection. Microbial biofilm composition did not appear to be affected by the design of peripherally inserted central catheter biomaterials or antibiotic therapy. However, the diversity of the microbial communities appeared to decrease with dwell time.",2020,Microbial biofilm composition did not appear to be affected by the design of peripherally inserted central catheter biomaterials or antibiotic therapy.,['paediatric patients'],"['polyurethane and hydrophobic catheters', 'central catheters ( n = 17 polyurethane vs n = 15 hydrophobic) were populated with complex microbial communities, including peripherally inserted central catheters considered non-colonised']","['microbial biofilm composition', 'microbial communities', 'diversity of microbial communities', 'Microbial biofilm composition']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",32.0,0.0689821,Microbial biofilm composition did not appear to be affected by the design of peripherally inserted central catheter biomaterials or antibiotic therapy.,"[{'ForeName': 'Maddie', 'Initials': 'M', 'LastName': 'Higgins', 'Affiliation': 'School of Environment and Science, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Dentistry and Oral Health, Gold Coast Campus, Griffith University, QLD, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ford', 'Affiliation': 'School of Environment and Science, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Brownlie', 'Affiliation': 'School of Environment and Science, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Kleidon', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Ullman', 'Affiliation': 'Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Brisbane, QLD, Australia.'}]",The journal of vascular access,['10.1177/1129729820932423'] 2082,32564804,An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care.,"INTRODUCTION The use of screening can prevent death from colorectal cancer, yet people without regular healthcare visits may not realize the benefits of this preventive intervention. The objective of this study was to determine the effectiveness of a mailed screening invitation or mailed fecal immunochemical test in increasing colorectal cancer screening uptake in veterans without recent primary care encounters. STUDY DESIGN Three-arm pragmatic randomized trial. SETTING/PARTICIPANTS Participants were screening-eligible veterans aged 50-75 years, without a recent primary care visit who accessed medical services at the Corporal Michael J. Crescenz Veteran Affairs Medical Center between January 1, 2017, and July 31, 2017. All data were analyzed from March 1, 2018, to July 31, 2018. INTERVENTION Participants were randomized to (1) usual opportunistic screening during a healthcare visit (n=260), (2) mailed invitation to screen and reminder phone calls (n=261), or (3) mailed fecal immunochemical test outreach plus reminder calls (n=61). MAIN OUTCOME MEASURES The main outcome under investigation was the completion of colorectal cancer screening within 6 months after randomization. RESULTS Of 782 participants in the trial, 53.9% were aged 60-75 years and 59.7% were African American. The screening rate was higher in the mailed fecal immunochemical test group (26.1%) compared with usual care (5.8%) (rate difference=20.3%, 95% CI=14.3%, 26.3%; RR=4.52, 95% CI=2.7, 7.7) or screening invitation (7.7%) (rate difference=18.4%, 95% CI=12.2%, 24.6%; RR=3.4, 95% CI=2.1, 5.4). Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5). CONCLUSIONS Mailed fecal immunochemical test screening promotes colorectal cancer screening participation among veterans without a recent primary care encounter. Despite the addition of reminder calls, an invitation letter was no more effective in screening participation than screening during outpatient appointments. TRIAL REGISTRATION This study is registered at clinicaltrials.gov NCT02584998.",2020,"Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5). ","['782 participants in the trial, 53.9% were aged 60-75 years and 59.7% were African American', 'Veterans Without Recent Primary Care', 'Participants were screening-eligible veterans aged 50-75 years, without a recent primary care visit who accessed medical services at the Corporal Michael J. Crescenz Veteran Affairs Medical Center between January 1, 2017, and July 31, 2017', 'veterans without a recent primary care encounter', 'veterans without recent primary care encounters']","['usual opportunistic screening during a healthcare visit (n=260), (2) mailed invitation to screen and reminder phone calls (n=261), or (3) mailed fecal immunochemical test outreach plus reminder calls (n=61', 'mailed screening invitation or mailed fecal immunochemical test']","['screening invitation', 'Screening completion rates', 'completion of colorectal cancer screening', 'screening rate']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0422389', 'cui_str': 'Opportunistic screening'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",,0.289727,"Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5). ","[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Goldshore', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: matthew.goldshore@pennmedicine.upenn.edu.'}, {'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Woodrow', 'Initials': 'W', 'LastName': 'Fletcher', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Center for Health Equity and Community Engagement Research, Mayo Clinic, Rochester, Minnesota; Department of Family Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'E Carter', 'Initials': 'EC', 'LastName': 'Paulson', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.014'] 2083,32564819,"Re: Goldberg et al.: A phase 3, randomized, double-masked study of OTX-101 ophthalmic solution 0.09% in the treatment of dry eye disease (Ophthalmology. 2019;126:1230-1237).",,2020,,['dry eye disease (Ophthalmology'],['OTX-101 ophthalmic solution'],[],"[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]","[{'cui': 'C0015399', 'cui_str': 'Eye drops'}]",[],,0.335132,,"[{'ForeName': 'Mumta', 'Initials': 'M', 'LastName': 'Kanda', 'Affiliation': 'Department of Ophthalmology, Royal Hospital London, London, UK. Electronic address: mumta.kanda1@nhs.net.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Nowak', 'Affiliation': 'Department of Ophthalmology, Royal Hospital London, London, UK.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.047'] 2084,32564889,"Erratum to ""Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial"" [Radiother. Oncol. 147 (2020) 75-83].",,2020,,"['147', 'high-risk rectal cancer ']","['preoperative chemotherapy and surgery', 'short-course radiotherapy']",[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.036791,,"[{'ForeName': 'Maxime J M', 'Initials': 'MJM', 'LastName': 'van der Valk', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: mvandervalk@lumc.nl.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands; Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University of Groningen, The Netherlands.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Hilling', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Elma', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Jan Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, Slovenia.'}, {'ForeName': 'Andrès M R', 'Initials': 'AMR', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Derk Jan A', 'Initials': 'DJA', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, University of Groningen, The Netherlands.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University of Groningen, The Netherlands. Electronic address: g.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.006'] 2085,32564920,Efficacy and Safety of Intravitreal Sirolimus for Noninfectious Uveitis of the Posterior Segment: Results from the Sirolimus Study Assessing Double-Masked Uveitis Treatment (SAKURA) Program.,"PURPOSE To evaluate the efficacy and safety of intravitreal sirolimus in the management of noninfectious uveitis of the posterior segment (NIU-PS). DESIGN Combined analysis of 2 phase 3, randomized, double-masked, multinational, 6-month studies. PARTICIPANTS Adults with active NIU-PS (intermediate uveitis, posterior uveitis, or panuveitis; defined as vitreous haze [VH] ≥1.5+ on modified Standardization of Uveitis Nomenclature scale). METHODS Patients were randomized 1:1:1 to receive intravitreal sirolimus 44 μg (n = 208), 440 μg (n = 208), or 880 μg (n = 177) on days 1, 60, and 120. Patients discontinued medications for NIU-PS except for systemic corticosteroids, which were tapered according to protocol. Enrollment in the 880-μg group was terminated after interim results found no significant difference in efficacy compared with the 440-μg dose. MAIN OUTCOME MEASURES The primary efficacy end point was the percentage of patients with VH of 0 at month 5 in the study eye without the use of rescue therapy. Secondary efficacy end points included VH of 0 or 0.5+, corticosteroid-tapering success, and changes in best-corrected visual acuity (BCVA). Safety measures included ocular and nonocular adverse events. RESULTS A total of 592 patients were randomized. Significantly higher proportions of patients treated with 440 μg compared with 44 μg intravitreal sirolimus achieved VH of 0 (21.2% vs. 13.5%; P = 0.038) and VH of 0 or 0.5+ (50.0% vs. 40.4%; P = 0.049) at month 5. Best-corrected visual acuity was stable (absolute change <5 ETDRS letters) or improved >5 letters in 80.1% and 80.2% of patients in the 440-μg and 44-μg groups, respectively. At month 5, corticosteroids were tapered successfully in 69.6% and 68.8% of patients in the 440-μg and 44-μg groups, and among these patients, VH of 0 or 0.5+ was achieved by 43.5% and 28.1% in the 440-μg and 44-μg groups. Both doses were generally well tolerated. Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups. CONCLUSIONS Intravitreal sirolimus 440 μg improved ocular inflammation, as measured by VH, compared with the 44-μg dose, with minimal impact on IOP, while preserving BCVA.",2020,"Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups. ","['592 patients were randomized', 'Patients', 'Noninfectious Uveitis of the Posterior Segment', 'Adults with active NIU-PS (intermediate uveitis, posterior uveitis, or panuveitis; defined as vitreous haze [VH] ≥1.5+ on modified Standardization of Uveitis Nomenclature scale', '440 μg (n\xa0= 208), or 880 μg (n\xa0= 177) on days 1, 60, and 120']","['Intravitreal Sirolimus', 'intravitreal sirolimus 44 μg ', 'intravitreal sirolimus']","['Efficacy and Safety', 'Mean changes from baseline intraocular pressure (IOP', 'tolerated', 'Best-corrected visual acuity', 'efficacy and safety', 'ocular inflammation', 'efficacy', 'ocular and nonocular adverse events', 'VH of 0 or 0.5+, corticosteroid-tapering success, and changes in best-corrected visual acuity (BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042166', 'cui_str': 'Intermediate uveitis'}, {'cui': 'C0042167', 'cui_str': 'Posterior uveitis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4073113', 'cui_str': 'Vitreous haze'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0600281', 'cui_str': 'Nomenclature'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",592.0,0.292917,"Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups. ","[{'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Merrill', 'Affiliation': 'Department of Ophthalmology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'W Lloyd', 'Initials': 'WL', 'LastName': 'Clark', 'Affiliation': 'Department of Ophthalmology, Palmetto Retina Center, LLC, West Columbia, South Carolina.'}, {'ForeName': 'Alay S', 'Initials': 'AS', 'LastName': 'Banker', 'Affiliation': ""Banker's Retina Clinic and Laser Center, Navrangpura, Ahmedabad, India.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fardeau', 'Affiliation': 'Department of Ophthalmology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Franco', 'Affiliation': 'Organización Médica de Investigación, Buenos Aires, Argentina.'}, {'ForeName': 'Phuc', 'Initials': 'P', 'LastName': 'LeHoang', 'Affiliation': 'Department of Ophthalmology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Shigeaki', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Sivakumar R', 'Initials': 'SR', 'LastName': 'Rathinam', 'Affiliation': 'Department of Uveitis Services, Aravind Eye Hospital, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Ali', 'Affiliation': 'Ribomic USA Inc., Berkeley, California.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Mudumba', 'Affiliation': 'Global Biomedical Strategy and Research, Santen, Inc., Emeryville, California.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Shams', 'Affiliation': 'Global Research and Development, Santen, Inc., Emeryville, California.'}, {'ForeName': 'Quan Dong', 'Initials': 'QD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California. Electronic address: ndquan@stanford.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.033'] 2086,32565102,"Sensory interventions on motor function, activities of daily living, and spasticity of the upper limb in people with stroke: A randomized clinical trial.","STUDY DESIGN This is a single-blinded clinical trial study. Clinical Trial Number registry: IRCT201610223551N4. INTRODUCTION Stroke is the second cause of death around the world. Motor and sensory problems are common complications of the stroke. These defects in the upper limb cause reduced use of the affected limb and consequently a decrease in the quality of life. PURPOSE OF THE STUDY The purpose of this study was to examine the effect of exteroceptive and proprioceptive stimulations on motor function, spasticity of the upper limb, and activities of daily living in people who have had stroke. METHODS Sixty people with chronic stroke selected by convenience sampling. Before the intervention, Modified Ashworth Scale, Fugl-Meyer assessment of Motor Recovery after Stroke, and Barthel Index were measured and then the intervention phase was started. Exteroceptive and proprioceptive sensory stimulations were performed for 6 weeks. Independent t-test was used to compare groups. RESULTS The intervention group made improvement in motor function (P = .0001, Cohen's d = 2.14), activities of daily living of upper limb (P = .0001, Cohen's d = 1.32), and spasticity (P = .002, Cohen's d = -0.94). DISCUSSION Motor function and activities of daily living and spasticity of the upper limb can be improved through exteroceptive and proprioceptive stimulations. In this study, this type of intervention had the most impact on motor function compared with the rest. CONCLUSION Exteroceptive and proprioceptive stimulations in upper limb can be used in chronic phase of stroke. Improvement in motor function and activities of daily living and reducing spasticity are the results of these stimulations.",2020,"The intervention group made improvement in motor function (P = .0001, Cohen's d = 2.14), activities of daily living of upper limb (P = .0001, Cohen's d = 1.32), and spasticity (P = .002, Cohen's d = -0.94). ","['Sixty people with chronic stroke selected by convenience sampling', 'people with stroke', 'people who have had stroke']","['Exteroceptive and proprioceptive stimulations', 'Sensory interventions', 'exteroceptive and proprioceptive stimulations']","['quality of life', 'Exteroceptive and proprioceptive sensory stimulations', 'motor function and activities of daily living and reducing spasticity', 'motor function, spasticity of the upper limb, and activities of daily living', 'activities of daily living of upper limb', 'spasticity', 'motor function, activities of daily living, and spasticity of the upper limb', 'motor function', 'Modified Ashworth Scale, Fugl-Meyer assessment of Motor Recovery after Stroke, and Barthel Index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",60.0,0.0669052,"The intervention group made improvement in motor function (P = .0001, Cohen's d = 2.14), activities of daily living of upper limb (P = .0001, Cohen's d = 1.32), and spasticity (P = .002, Cohen's d = -0.94). ","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Derakhshanfar', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Raji', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: praji@tums.ac.ir.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Bagheri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Jalili', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Tarhsaz', 'Affiliation': 'School of Razi, Kermanshah, Iran.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.028'] 2087,32565105,Home exercise in the dart-throwing motion plane after distal radius fractures: A pilot randomized controlled trial.,"STUDY DESIGN This is an intrasubject cross-sectional study. INTRODUCTION Upper limb injuries often require wearing an orthosis. Today, orthoses are custom-made by the clinician or purchased as an off-shelf product. Although 3D printing is a popular solution, the design and adjustment of an orthosis model according to patient-specific anatomy requires technical expertise, often unavailable to the clinicians. PURPOSE OF THE STUDY The purposes of this study were (a) to create software that receives input of anatomic dimensions of the finger and automatically adjusts an orthosis model for patient-specific 3D printing and (b) to compare preparation time, product weight, and user satisfaction of occupational therapy students between the manual method and the automatic 3D printing method. METHODS A custom code allows the user to measure five anatomic measurements of the finger. The code adjusts a swan-neck orthosis model according to the patient-specific measurements and a fitted resized 3D-printable file is produced. We recruited 36 occupational therapy students (age 25.4±1.9 years). They prepared two swan-neck orthoses for a finger of a rubber mannequin: one manually using a thermoplastic material and the other by 3D printing. The preparation time and orthosis weight were measured and the subjects filled out a user satisfaction questionnaire. RESULTS The weight of the 3D-printed orthosis was significantly lower than that of the manual orthosis; however, the preparation time was longer. The subjects were more satisfied with the fit, esthetics, overall process, and product of the 3D-printed orthosis. CONCLUSION The creation of automated software for the patient-specific adjustment of orthoses for 3D printing can be the missing link for integration of 3D printing in the clinics.",2020,The creation of automated software for the patient-specific adjustment of orthoses for 3D printing can be the missing link for integration of 3D printing in the clinics.,"['36 occupational therapy students (age 25.4±1.9 years', 'distal radius fractures']",['Home exercise'],"['preparation time and orthosis weight', 'weight of the 3D-printed orthosis']","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]",36.0,0.0227074,The creation of automated software for the patient-specific adjustment of orthoses for 3D printing can be the missing link for integration of 3D printing in the clinics.,"[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Kaufman-Cohen', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yafi', 'Initials': 'Y', 'LastName': 'Levanon', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Occupational Therapy Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': 'Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yona', 'Initials': 'Y', 'LastName': 'Yaniv', 'Affiliation': 'Orthopedic Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Portnoy', 'Affiliation': 'Department of Occupational Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: portnoys@tauex.tau.ac.il.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.027'] 2088,32565122,A Secondary Analysis from a Randomized Trial on the Effect of Plasma Tetrahydrocannabinol Levels on Pain Reduction in Painful Diabetic Peripheral Neuropathy.,"This report examines the association between THC plasma levels and pain response in a secondary analysis of data from a recent diabetic neuropathy study that demonstrated a dose-dependent reduction in spontaneous and elicited pain at specific time points. A randomized, double-blinded, placebo-controlled crossover study was conducted in sixteen patients with painful diabetic peripheral neuropathy (PDN). Subjects participated in four sessions, separated by 2 weeks, during each of which they were exposed to one of four conditions: placebo, or 1%, 4% or 7% THC dose of cannabis. Baseline assessments of spontaneous and evoked pain were performed. Subjects were then administered aerosolized cannabis or placebo and pain intensity and cognitive testing at specific time points for 4 hours. A blood sample was drawn from the left antecubital vein for plasma assay of total THC at 0, 15, 30, 45, 60, 150, and 240 minutes. Associations were made between pain intensity, cognitive impairment and THC plasma levels in this secondary analysis. Results suggested a U-shaped relation whereby pain ratings are greatest at extreme (low and high) levels of THC. The therapeutic window appeared to fall between 16 ng/ml and 31 ng/ml THC plasma level. There was a significant linear effect of THC on only one out of the three cognitive tests. These findings stress the importance of measuring cannabinoid plasma levels when performing future research. PERSPECTIVE: This analysis correlating plasma THC levels and pain reduction in diabetic neuropathy suggest a therapeutic window. Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). There was a minor negative linear effect of THC on cognitive function.",2020,Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). ,"['sixteen patients with painful diabetic peripheral neuropathy (PDN', 'Painful Diabetic Peripheral Neuropathy']","['THC', 'Plasma Tetrahydrocannabinol Levels', 'aerosolized cannabis or placebo', 'placebo']","['THC levels', 'Pain Reduction', 'cognitive function', 'pain intensity, cognitive impairment and THC plasma levels', 'THC plasma level', 'pain ratings', 'spontaneous and evoked pain', 'THC plasma levels and pain response']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",16.0,0.176395,Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). ,"[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Wallace', 'Affiliation': 'Department of Anesthesiology, School of Medicine, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093. Electronic address: mswallace@ucsd.edu.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Marcotte', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093; Department of Psychiatry, VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161.'}, {'ForeName': 'Hayley Treloar', 'Initials': 'HT', 'LastName': 'Padovano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Center for Alcohol and Addiction Studies, Brown University, 121 South Main Street, Providence, RI 02903.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bonn-Miller', 'Affiliation': 'Director, Cannabinoid Research, Zynerba Pharmaceuticals, 80 W. Lancaster Ave., Suite 300, Devon, PA 19333.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.03.003'] 2089,32565123,An acute bout of swimming increases post-exercise energy intake in young healthy men and women.,"Single bouts of land-based exercise (for example, walking, running, cycling) do not typically alter post-exercise energy intake on the day of exercise. However, anecdotal and preliminary empirical evidence suggests that swimming may increase appetite and energy intake. This study compared the acute effects of swimming on appetite, energy intake, and food preference and reward, versus exertion-matched cycling and a resting control. Thirty-two men (n = 17; mean ± SD age 24 ± 2 years, body mass index [BMI] 25.0 ± 2.6 kg/m 2 ) and women (n = 15; age 22 ± 3 years, BMI 22.8 ± 2.3 kg/m 2 ) completed three experimental trials (swimming, cycling, control) in a randomised, crossover design. The exercise trials involved 60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast. Food preference and reward were assessed via the Leeds Food Preference Questionnaire 15-min after exercise, whilst ad libitum energy intake was determined 30-min after exercise. The control trial involved identical procedures except no exercise was performed. Compared with control (3259 ± 1265 kJ), swimming increased ad libitum energy intake (3857 ± 1611 kJ; ES = 0.47, 95% CI of the mean difference between trials 185, 1010 kJ, P = 0.005); the magnitude of increase was smaller after cycling (3652 ± 1619 kJ; ES = 0.31, 95% CI -21, 805 kJ, P = 0.062). Ad libitum energy intake was similar between swimming and cycling (ES = 0.16, 95% CI -207, 618 kJ, P = 0.324). This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control. This study has identified an orexigenic effect of swimming. Further research is needed to identify the responsible mechanism(s), including the relevance of water immersion and water temperature per se.",2020,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"['young healthy men and women', 'Thirty-two men (n\u202f=\u202f17; mean\u202f±\u202fSD age 24\u202f±\u202f2 years, body mass index [BMI] 25.0\u202f±\u202f2.6\u202fkg/m 2 ) and women (n\u202f=\u202f15', 'age 22\u202f±\u202f3 years, BMI 22.8\u202f±\u202f2.3\u202fkg/m 2 ']","[""60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast"", 'Single bouts of land-based exercise']","['appetite, energy intake, and food preference and reward, versus exertion-matched cycling', 'Ad libitum energy intake', 'appetite and energy intake']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",,0.135485,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.E.Thackray@lboro.ac.uk.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: S.Willis2@lboro.ac.uk.'}, {'ForeName': 'Aron P', 'Initials': 'AP', 'LastName': 'Sherry', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.P.Sherry@lboro.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, UK. Electronic address: David.Clayton@ntu.ac.uk.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Academy of Sport and Physical Activity, Sheffield Hallam University, UK. Electronic address: D.R.Broom@shu.ac.uk.'}, {'ForeName': 'Mayada', 'Initials': 'M', 'LastName': 'Demashkieh', 'Affiliation': 'Department of Physical Education and Sport Science, Nanyang Technological University, Singapore. Electronic address: Mayada.Demashkieh@nie.edu.sg.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK; Diabetes Research Centre, University of Leicester, UK. Electronic address: js928@leicester.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK. Electronic address: L.James@lboro.ac.uk.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, UK. Electronic address: G.S.Finlayson@leeds.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: D.J.Stensel@lboro.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: j.a.king@lboro.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104785'] 2090,32565333,In vivo evaluation of effect of pre-operative ibuprofen on pro-inflammatory mediators in irreversible pulpitis cases.,"INTRODUCTION Pre-operative administration of NSAIDs have been suggested as a method for increasing the efficacy of local anesthetics and decreasing post-operative pain in symptomatic irreversible pulpitis cases. However, the effects of ibuprofen at the molecular level are still unknown. Hence, the purpose of this study is to compare the levels of pro-inflammatory mediators in the dental pulp of teeth with irreversible pulpitis in patients who medicated with pre-operative ibuprofen versus those who did not. METHODS Thirty-four patients undergoing conventional endodontic therapy for teeth with irreversible pulpitis were selected and randomly assigned into either the ibuprofen or non-ibuprofen group. Four patients undergoing endodontic therapy for prosthodontic reasons served as controls. Patients in the ibuprofen group were instructed to take 600mg of ibuprofen one-hour prior to treatment, while patients in the non-ibuprofen and control groups were asked to avoid analgesics prior to treatment. Blood samples obtained from the pulp upon access were tested for levels of PGE2, TNF-α, IL-6, IL-1β and IFN-γ using high sensitivity ELISAs. Post-operative pain levels were recorded for the groups. Data for the cytokine levels and post-operative pain were analyzed using statistical analysis. RESULTS There was a significant decrease in the levels of PGE2, TNF-α, IL-6, and IFN-γ in the ibuprofen group as compared to the non-ibuprofen group. No significant differences were noted in the post-operative pain levels between these groups. CONCLUSIONS The data demonstrated that the pre-operative ibuprofen significantly decreased the levels of most pro-inflammatory cytokines in the dental pulp, which could possibly help with anesthesia in irreversible cases.",2020,"There was a significant decrease in the levels of PGE2, TNF-α, IL-6, and IFN-γ in the ibuprofen group as compared to the non-ibuprofen group.","['irreversible pulpitis cases', 'Four patients undergoing', 'Thirty-four patients undergoing', 'for teeth with irreversible pulpitis', 'dental pulp of teeth with irreversible pulpitis in patients who medicated with pre-operative ibuprofen versus those who did not']","['pre-operative ibuprofen', 'ibuprofen or non-ibuprofen', 'conventional endodontic therapy', 'endodontic therapy', 'ibuprofen']","['post-operative pain levels', 'levels of PGE2, TNF-α, IL-6, and IFN-γ', 'levels of PGE2, TNF-α, IL-6, IL-1β and IFN-γ using high sensitivity ELISAs', 'Post-operative pain levels', 'cytokine levels and post-operative pain', 'levels of most pro-inflammatory cytokines']","[{'cui': 'C0399406', 'cui_str': 'Irreversible pulpitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",4.0,0.0251917,"There was a significant decrease in the levels of PGE2, TNF-α, IL-6, and IFN-γ in the ibuprofen group as compared to the non-ibuprofen group.","[{'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Yen-Wei', 'Initials': 'YW', 'LastName': 'Chen', 'Affiliation': 'Department of Restorative Dentistry, University of Washington, Seattle, Washington.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Johnson', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Avina', 'Initials': 'A', 'LastName': 'Paranjpe', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington. Electronic address: avina@uw.edu.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.009'] 2091,32566980,Partial resection of the infrapatellar fat pad during anterior cruciate ligament reconstruction has no effect on clinical outcomes including anterior knee pain.,"BACKGROUND Anterior knee pain (AKP) is a major complication that occurs after anterior cruciate ligament reconstruction (ACLR), even when hamstring tendon (HT) grafts are used. Damage to the infrapatellar fat pad (IPFP) during arthroscopy can cause AKP. The purpose of this study was to evaluate the influence of IPFP preservation on clinical outcomes, including AKP, in patients who underwent ACLR with HT autografts using the inside-out technique. METHODS Forty-two patients who underwent primary ACLR with HT autografts were prospectively assessed for 2 years after surgery. They were randomly selected to undergo treatment with as much intercondylar IPFP preservation as possible or with intercondylar IPFP resection to confirm the ACL origin on the femoral and tibial sides, especially the femoral footprint in deep flexion of the knee joint. The total IPFP volume was calculated using sagittal MR images before and 6 months after surgery. The patients completed a subjective knee score questionnaire and were assessed for patellar tendon tenderness and pain with the half-squat test or single-leg hop test at 6 months and 2 years postoperatively. RESULTS There were no differences in the patient characteristics, including age, sex, BMI, time from injury to surgery, and meniscus tear. The difference in the total size of the IPFP preserved was significant (P = 0.004). However, there were no significant differences in the subjective knee scores. Moreover, there were no differences in the clinical assessment parameters between the IPFP preservation and resection groups. CONCLUSIONS The size of the IPFP decreased more in the resection group than in the preservation group at 6 months after surgery. However, partial IPFP resection, which was used to better visualize the origin of the ACL, had no effect on the clinical outcomes, including AKP. LEVEL OF EVIDENCE Level II.",2020,The difference in the total size of the IPFP preserved was significant (P = 0.004).,"['Forty-two patients who underwent primary ACLR with HT autografts were prospectively assessed for 2\xa0years after surgery', 'patients who underwent ACLR with HT autografts using the inside-out technique', 'anterior knee pain']","['IPFP', 'intercondylar IPFP preservation as possible or with intercondylar IPFP resection to confirm the ACL origin', 'anterior cruciate ligament reconstruction (ACLR', 'anterior cruciate ligament reconstruction']","['total IPFP volume', 'size of the IPFP', 'subjective knee score questionnaire', 'subjective knee scores', 'patellar tendon tenderness and pain', 'total size of the IPFP']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}]","[{'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",42.0,0.0175713,The difference in the total size of the IPFP preserved was significant (P = 0.004).,"[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Junsuke', 'Initials': 'J', 'LastName': 'Nakase', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan. nakase1007@yahoo.co.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Shimozaki', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Rikuto', 'Initials': 'R', 'LastName': 'Yoshimizu', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03520-5'] 2092,32567012,Phase II multi-institutional prospective trial of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer refractory to fluoropyrimidine with modified dose reduction criteria (CCOG1303).,"BACKGROUND The aim of this study was to explore the efficacy and safety of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer with modified dose reduction criteria by which the doses were manipulated earlier. METHODS Gastric cancer patients who developed progression during the fluoropyrimidine-containing first-line chemotherapy were assigned to receive nab-paclitaxel (260 mg/m 2 ) by triweekly administration. Dose reduction was regulated according to predefined toxicity criteria which included neutropenia less than 1000/mm 3 and/or peripheral sensory neuropathy of grade 2 or more. The primary endpoint was progression-free survival. RESULTS A total of 50 patients were enrolled, 47 of whom were eligible for efficacy analyses. The median number of treatment cycles and relative dose intensity given per patient was four (range 1-25), and 90% (range 60-100). Of total administration throughout the trial of 280 cycles, dose reduction was required in 50 cycles. The median progression-free survival was 3.5 months (95% confidence interval 2.5-4.4) that met the primary endpoint. The median overall survival was 9.0 months (95% confidence interval 6.8-11.8), overall response rate was 16% (95% confidence interval 2-30), and disease control rate was 72% (95% confidence interval 54-90). The median time to treatment failure was 3.5 months (95% confidence interval 2.5-4.4). Adverse events of grade 3 or worse included neutropenia in 49%, and peripheral sensory neuropathy in 11%. Febrile neutropenia occurred only in one patient (2%). CONCLUSION The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.",2020,The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.,"['A total of 50 patients were enrolled, 47 of whom were eligible for efficacy analyses', 'advanced gastric cancer', 'advanced gastric cancer refractory to', 'Gastric cancer patients who developed progression during the fluoropyrimidine-containing first-line chemotherapy']","['fluoropyrimidine', 'nab-paclitaxel']","['disease control rate', 'median number of treatment cycles', 'median progression-free survival', 'progression-free survival', 'median time to treatment failure', 'severe peripheral sensory neuropathy', 'efficacy and safety', 'overall response rate', 'Adverse events of grade 3 or worse included neutropenia', 'median overall survival', 'peripheral sensory neuropathy', 'Febrile neutropenia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}]",50.0,0.32366,The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.,"[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. kobadai@med.nagoya-u.ac.jp.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Surgery, Komaki City Hospital, Komaki, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Torii', 'Affiliation': 'Department of Surgery, Meitetsu Hospital, Nagoya, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takeda', 'Affiliation': 'Department of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Kawase', 'Affiliation': 'Department of Surgery, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ishigure', 'Affiliation': 'Department of Surgery, Konan Kosei Hospital, Konan, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Teramoto', 'Affiliation': 'Department of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kodera', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01724-8'] 2093,32567124,Oral versus intravenous palonosetron in Chinese cancer patients receiving moderately emetogenic chemotherapy: A non-inferiority phase III trial.,"OBJECTIVE The 5-hydroxytryptamine-3 receptor antagonist palonosetron (PALO) is approved (United States/Europe) as an oral formulation for prevention of chemotherapy-induced nausea and vomiting in adult cancer patients undergoing moderately emetogenic chemotherapy (MEC) for the acute phase only, in the United States, or as intravenous (IV) formulation in patients undergoing MEC or highly emetogenic chemotherapy. This phase III study compares the efficacy/safety of oral versus IV PALO in Chinese patients. METHODS Chemotherapy-naive patients with solid tumours scheduled for MEC received oral PALO 0.50 mg or IV PALO 0.25 mg. The primary objective was to demonstrate non-inferiority in terms of patients with complete response in the acute phase (0-24 hr post-chemotherapy). RESULTS Complete response rates (acute phase), evaluated in 318/320 randomised patients, were 84.6% and 85.9% for oral and IV PALO respectively. Non-inferiority was demonstrated; the two formulations showed similar efficacy/safety. CONCLUSION Non-inferiority of oral versus IV PALO in the acute phase was demonstrated in Chinese patients. CLINICAL TRIAL REGISTRATION CTR20140711.",2020,"Non-inferiority was demonstrated; the two formulations showed similar efficacy/safety. ","['Chinese cancer patients receiving moderately emetogenic chemotherapy', 'Chinese patients', 'adult cancer patients undergoing moderately', 'patients undergoing MEC or highly emetogenic chemotherapy', 'Chemotherapy-naive patients with solid tumours scheduled for']","['MEC received oral PALO 0.50\xa0mg or IV PALO 0.25\xa0mg', 'Oral versus intravenous palonosetron', 'oral versus IV PALO', 'emetogenic chemotherapy (MEC', '5-hydroxytryptamine-3 receptor antagonist palonosetron (PALO']","['efficacy/safety', 'nausea and vomiting']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4691686', 'cui_str': 'palonosetron 0.25 MG'}, {'cui': 'C0360055', 'cui_str': '5-HT3 receptor antagonist'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",,0.216724,"Non-inferiority was demonstrated; the two formulations showed similar efficacy/safety. ","[{'ForeName': 'Jiuwei', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, Guangdong, China.'}, {'ForeName': 'Tulla', 'Initials': 'T', 'LastName': 'Spinelli', 'Affiliation': 'Helsinn Healthcare SA, Pambio-Noranco, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Nicolas', 'Affiliation': 'Helsinn Healthcare SA, Pambio-Noranco, Switzerland.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, Jilin, China.'}]",European journal of cancer care,['10.1111/ecc.13245'] 2094,32567140,"Physical Activity, Sitting Time, and Sleep Duration Before and During Pregnancy and Pregnancy Outcomes: A Prospective Panel Study.","AIMS AND OBJECTIVES To examine how changes in physical activity, sitting time, and sleep duration through pre-, mid-, and late pregnancy in association with caesarean section, medically-indicated caesarean section, and small for gestational age. BACKGROUND While circadian activities could change throughout pregnancy, studies exploring the effect of change in those activities on pregnancy outcomes remain limited. DESIGN This study applied a prospective panel design. METHODS A self-reported questionnaire was used to assess the three activities before and during pregnancy, and was administered three times from August 2015 through July 2017. Multiple logistic regression models were used. The analysis included 488, 477, and 455 participants in the models for caesarean section, medically-indicated caesarean section, and small for gestational age, respectively. This study followed the STROBE guidelines. RESULTS The mean age of participants was 32.18 years, and more than half (54.90%) were primiparous. Sleep duration >8 hours/day before pregnancy and experiencing a decrease in mid-pregnancy was a risk factor for caesarean section and medically-indicated caesarean section. Sitting ≥8 hours/weekday in pre-, mid-, and late pregnancy had a protective effect for caesarean section and medically-indicated caesarean section. Sitting <8 hours in mid-pregnancy and experiencing a decrease in late pregnancy was a risk factor for small for gestational age infants. Physical activity was not significantly related to pregnancy outcomes. CONCLUSION Sleep duration of 7 to 8 hours and sitting time of more than 8 hours/day seem beneficial for women both before and during pregnancy. RELEVANCE TO CLINICAL PRACTICE Health professionals could assess pregnant women or those intending to become pregnant regarding their sleep and sitting behaviour and provide relevant interventions.",2020,"Physical activity was not significantly related to pregnancy outcomes. ","['The mean age of participants was 32.18 years, and more than half (54.90%) were primiparous', 'The analysis included 488, 477, and 455 participants in the models for caesarean section, medically-indicated caesarean section, and small for gestational age, respectively']",['Sitting'],"['Physical Activity, Sitting Time, and Sleep Duration', 'Physical activity', 'physical activity, sitting time, and sleep duration through pre-, mid-, and late pregnancy in association with caesarean section, medically-indicated caesarean section, and small for gestational age', 'Sleep duration', 'protective effect for caesarean section and medically-indicated caesarean section', 'late pregnancy']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0188153,"Physical activity was not significantly related to pregnancy outcomes. ","[{'ForeName': 'Shiue-Shan', 'Initials': 'SS', 'LastName': 'Weng', 'Affiliation': 'Instructor, Institute of Community Health Care, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Tzu Chi Hospital, Taipei, Taiwan.'}, {'ForeName': 'Li-Yin', 'Initials': 'LY', 'LastName': 'Chien', 'Affiliation': 'Institute of Community Health Care, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15388'] 2095,32567217,"Pharmacokinetics and Pharmacodynamics of Two Formulations of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor in Healthy Chinese Subjects: An Open-Label, Randomized, Parallel-Design Bioavailability Study.","Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, pegfilgrastim) is a long-acting derivative of recombinant human granulocyte colony-stimulating factor with limited renal clearance and a longer half-life. It is used for the prevention of febrile neutropenia, owing to its capacity to promote neutrophil recovery. In this study, the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of 2 formulations of PEG-rhG-CSF were evaluated in healthy Chinese subjects. Twenty-four male subjects who received a single dose of subcutaneous PEG-rhG-CSF 100 µg/kg were randomized to either treatment A (3 mg/mL) or treatment B (1 mg/mL). Noncompartmental pharmacokinetic parameters of PEG-rhG-CSF were derived from serum concentration-time data. In addition, absolute neutrophil count (ANC) as a pharmacodynamic maker, immunogenicity through antidrug antibody testing, and safety were evaluated. The mean area under the concentration-time curve from time zero to the last quantifiable concentration (AUC 0-t ) and the mean maximum concentration (C max ) of PEG-rhG-CSF after treatment A were 5070 ng·h/mL and 125 ng/mL, respectively; these values were comparable to those measured after treatment B (5340 ng·h/mL and 123 ng/mL, respectively). The mean value of area under the △ANC (baseline-adjusted ANC)-time curve and the maximum △ANC values were 4380 × 10 9  h/L and 33.1 × 10 9 /L, respectively, in the treatment A group, and 5170 × 10 9  h/L and 38.6 × 10 9 /L, respectively, in the treatment B group. The pharmacokinetic and pharmacodynamic profiles were similar for the 2 PEG-rhG-CSF formulations following a single dose of 100 µg/kg. The safety and immunogenicity profiles were also similar, with no significant differences. The dose adjustment of PEG-rhG-CSF was not considered necessary for formulation transformation.",2020,"The safety and immunogenicity profiles were also similar, with no significant differences.","['Twenty-four male subjects who received a single dose of subcutaneous PEG-rhG-CSF 100\xa0µg/kg', 'Healthy Chinese Subjects', 'healthy Chinese subjects']","['PEG-rhG-CSF', 'Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, pegfilgrastim', 'Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor']","['absolute neutrophil count (ANC', 'mean area under the concentration-time curve', 'mean value of area under the △ANC', 'safety and immunogenicity profiles', 'pharmacokinetic and pharmacodynamic profiles', 'pharmacokinetics, pharmacodynamics, safety, and immunogenicity', 'mean maximum concentration (C max ) of PEG-rhG-CSF']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}]","[{'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}]",24.0,0.0294381,"The safety and immunogenicity profiles were also similar, with no significant differences.","[{'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Bingxin', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': 'Department of Hematology, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Wanling', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Medical Affair Office, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.819'] 2096,32567233,Effects of Oxycodone Combined With Flurbiprofen Axetil on Postoperative Analgesia and Immune Function in Patients Undergoing Radical Resection of Colorectal Cancer.,"The influence of surgery and anesthesia on immune function during the perioperative period should not be neglected. In this study, we evaluated the effects of oxycodone combined with flurbiprofen axetil on postoperative analgesia and immune function in patients undergoing radical resection of colorectal cancer (CRC). One hundred and thirty-three were randomized into the oxycodone combined with flurbiprofen axetil (OF) group or the sufentanil combined with flurbiprofen axetil (SF) group. Patients in the OF group were prescribed oxycodone hydrochloride 0.1 mg/kg combined with flurbiprofen axetil 3 mg/kg for postoperative analgesia, whereas the SF group received sufentanil 0.1 μg/kg combined with flurbiprofen axetil 3 mg/kg. The primary outcome was visual analog scale (VAS) score. Secondary outcomes included the quantities of CD4 + , CD8 + , and natural killer (NK) T cells, tumor necrosis factor (TNF)-α level, and interleukin (IL)-6 in peripheral blood, the consumption of analgesics, and the incidence of adverse reactions, and so forth. The VAS scores at rest were similar in both group. However, the VAS scores at cough in the OF group at 8, 12, and 24 hours postsurgery were lower than those in the SF group. Compared with the SF group, the count of CD4 + T cells and ratio of CD4 + /CD8 + were higher in the OF group at 12, 24, 48, and 72 hours postsurgery, although the count of CD8 + and NK T cells was higher than that in the SF group at 48 and 72 hours postsurgery. In addition, the serum level of TNF-α and IL-6 at 12, 24, 48, and 72 hours postsurgery in the OF group was lower than that in the SF group. In addition, the incidence of postoperative nausea, postoperative vomiting, and pruritus was lower, the time to first flatus and bowel movement was earlier in the OF group. Oxycodone combined with flurbiprofen axetil applied for patient-controlled intravenous analgesia could effectively reduce pain intensity, particularly for visceral pain, and help to reverse the status of immunosuppression during radical resection of CRC.",2020,"However, the VAS scores at cough in the OF group at 8, 12, and 24 hours postsurgery were lower than those in the SF group.","['patients undergoing radical resection of colorectal cancer (CRC', 'One hundred and thirty-three', 'Patients Undergoing Radical Resection of Colorectal Cancer']","['oxycodone hydrochloride', 'flurbiprofen axetil', 'oxycodone combined with flurbiprofen axetil (OF', 'SF', 'surgery and anesthesia', 'sufentanil 0.1 μg/kg combined with flurbiprofen axetil', 'Oxycodone', 'sufentanil combined with flurbiprofen axetil (SF', 'Oxycodone Combined With Flurbiprofen Axetil', 'oxycodone']","['visual analog scale (VAS) score', 'time to first flatus and bowel movement', 'quantities of CD4 + , CD8 + , and natural killer (NK) T cells, tumor necrosis factor (TNF)-α level, and interleukin (IL)-6 in peripheral blood, the consumption of analgesics, and the incidence of adverse reactions, and so forth', 'pain intensity', 'postoperative analgesia and immune function', 'VAS scores at cough', 'postoperative nausea, postoperative vomiting, and pruritus', 'count of CD4 + T cells and ratio of CD4 + /CD8 ', 'serum level of TNF-α and IL-6', 'count of CD8 + and NK T cells', 'Postoperative Analgesia and Immune Function', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517420', 'cui_str': '0.1'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C2350466', 'cui_str': 'Natural Killer T-Cell'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0520905', 'cui_str': 'Postoperative vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",133.0,0.043884,"However, the VAS scores at cough in the OF group at 8, 12, and 24 hours postsurgery were lower than those in the SF group.","[{'ForeName': 'Zhengzuo', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': 'Department of Anesthesiology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Chu', 'Affiliation': ""Department of Acupuncture and Massage, Zhejiang Provincial People's Hospital, Hangzhou, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Que', 'Affiliation': 'Department of Anesthesiology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.818'] 2097,32567357,Efficacy of shortwave diathermy in ulnar nerve entrapment at the elbow: a double-blind randomized controlled clinical trial.,"OBJECTIVE To investigate the efficacy of shortwave diathermy in treatment of ulnar nerve entrapment at the elbow. DESIGN The study was a double blind, randomized controlled clinical trial. SETTING, PARTICIPANTS A total of 76 adult patients diagnosed with ulnar nerve entrapment at the elbow clinically and electrophysiologically, were randomly assigned into two groups. Patients were evaluated at baseline, after completing treatment and 1 and 3 months after treatment. Physical examination, quick-DASH (disabilities of arm, shoulder, hand) and SF-36 (short form) questionnaires for daily life activities, dynamometer for grip strength, and visual analog scale for pain were used. INTERVENTION A total of 10 sessions of shortwave diathermy were applied to patients in treatment group as five sessions/week, 2 weeks. Control group was given placebo shortwave diathermy. Both groups were given elbow splints and informed to avoid symptom provoking activities. MAIN OUTCOME MEASURES Visual analog scale, grip strength, SF-36, and quick-DASH results. RESULTS Out of 76 patients, 61 of them completed the study where n  = 31 for treatment group and n  = 30 for control group. Mean age was 46.18 ± 13.45 years. There were 32 (52.5%) women and 29 (47.5%) men. The p values between groups 3 months after intervention for visual analog scale, quick-DASH, SF-36 questionnaire, and dynamometer were 0.669, 0.277, 0.604, and 0.126, respectively ( p  > 0.05). CONCLUSION Application of shortwave diathermy to patients with ulnar nerve neuropathy at the elbow was not associated with any difference in outcome.",2020,"The p values between groups 3 months after intervention for visual analog scale, quick-DASH, SF-36 questionnaire, and dynamometer were 0.669, 0.277, 0.604, and 0.126, respectively ( p  > 0.05). ","['A total of 76 adult patients diagnosed with ulnar nerve entrapment at the elbow clinically and electrophysiologically', '76 patients, 61 of them completed the study where n \u2009=\u200931 for treatment group and n \u2009=\u200930 for control group', 'Mean age was 46.18\u2009±\u200913.45\u2009years', 'ulnar nerve entrapment at the elbow']","['shortwave diathermy', 'placebo shortwave diathermy', 'elbow splints']","['Physical examination, quick-DASH (disabilities of arm, shoulder, hand) and SF-36 (short form) questionnaires for daily life activities, dynamometer for grip strength, and visual analog scale for pain', 'visual analog scale, quick-DASH, SF-36 questionnaire, and dynamometer', 'Visual analog scale, grip strength, SF-36, and quick-DASH results']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751658', 'cui_str': 'Ulnar nerve entrapment'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",76.0,0.139331,"The p values between groups 3 months after intervention for visual analog scale, quick-DASH, SF-36 questionnaire, and dynamometer were 0.669, 0.277, 0.604, and 0.126, respectively ( p  > 0.05). ","[{'ForeName': 'Naciye', 'Initials': 'N', 'LastName': 'Bilgin Badur', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Sureyyapasa Chest Diseases and Thoracic Surgery Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Feyza', 'Initials': 'F', 'LastName': 'Unlu Ozkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Aktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}]",Clinical rehabilitation,['10.1177/0269215520930062'] 2098,32567372,Application of Zizao Yangrong Granules for Treating Targeted Drugs-Related Skin Xerosis: A Randomized Double-Blinded Controlled Study.,"Background: Dermatologic toxicities are the most common side effects associated with the targeted drugs epidermal growth factor receptor inhibitors (EGFRIs), in which xerosis commonly complicated by pruritus severely disturbs the quality of life. The study has observed the curative effect of Zizao Yangrong granules (ZYG) from Chishui Xuanzhu in the treatment of EGFRIs-related xerosis and pruritus, as well as evaluating the safety of the prescription. Methods: Patients (n = 68) who had xerosis after using EGFRIs were enrolled and then randomly divided into the treatment group and control group, respectively, receiving ZYG and placebo granules combined with vitamin E ointment. The intervention lasted 4 weeks. Changes in xerosis and pruritus were observed, and blood routine examination as well as liver and kidney function are observed as safety indexes . The water content of skin and qualify of life were observed . Results: A total of 66 out of 68 patients finished the study with 34 patients in each group . The effective rates of xerosis among the treatment group and control group were 84.8% and 69.7% after 2 weeks' treatment ( P < .05), while they were 84.8% and 75.8% after 4 weeks' treatment ( P < .05). The patients in the experimental group had better quality of life than that in the control group ( P = .045). Conclusion: ZYG can effectively improve the skin dryness associated with EGFRIs, and significantly improve the quality of life of patients with good safety; however, larger randomized controlled trials are needed to verify these findings.",2020,The patients in the experimental group had better quality of life than that in the control group ( P = .045). ,"['A total of 66 out of 68 patients finished the study with 34 patients in each group ', 'Methods: Patients (n = 68) who had xerosis after using EGFRIs', 'Skin Xerosis']","['ZYG and placebo granules combined with vitamin E ointment', 'Zizao Yangrong granules (ZYG) from Chishui Xuanzhu', 'Zizao Yangrong Granules']","['quality of life', 'effective rates of xerosis', 'blood routine examination', 'xerosis and pruritus', 'Dermatologic toxicities', 'skin dryness', 'water content of skin and qualify of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}, {'cui': 'C0263465', 'cui_str': 'Asteatosis cutis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",68.0,0.0597227,The patients in the experimental group had better quality of life than that in the control group ( P = .045). ,"[{'ForeName': 'Yan Mei', 'Initials': 'YM', 'LastName': 'Peng', 'Affiliation': 'Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Chenyao', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Shuyue', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Tan', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hui Juan', 'Initials': 'HJ', 'LastName': 'Cui', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420924832'] 2099,32567433,Glycemic variability in type 2 diabetes mellitus and acute coronary syndrome: liraglutide compared with insulin glargine: a pilot study.,"OBJECTIVE To explore the glucagon-like peptide-1 analogue liraglutide in the hospital setting in patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome and to evaluate the safety and efficacy and its impact on hospitalization and short-term glycemic variability (GV). METHODS A 12-week, open-label, prospective, randomized pilot clinical study with parallel groups that compared liraglutide (group 1) with glargine (group 2) and its impact on glycemic control and GV. RESULTS Thirteen patients were included. During hospitalization, mean glucose was 164.75 mg/dL (standard deviation [SD] 19.94) in group 1 and 166.69 mg/dL (38.22) in group 2. GV determined by CV and SD was 20.98 (7.68) vs. 25.48 (7.19) and 34.37 (13.05) vs. 43.56 (19.53) in groups 1 and 2, respectively. Group 1 prandial insulin requirements during hospitalization were lower compared with group 2. Follow-up A1c in group 1 was 6.9% (-1.51%) and 6.5% in group 2 (-1.27). GV after discharge and hypoglycemia were lower in group 1 compared with group 2. CONCLUSIONS Liraglutide seems to reduce GV in the acute phase of acute coronary syndrome, and patients achieved optimal control with a low incidence of hypoglycemia. These results support the need to explore liraglutide in a larger multicenter trial. Trial registration: The study was approved by the National Medical Ethics Committee of Spain. The study was registered at European Clinical Trials Database (EudraCT): 2014003298-40.",2020,"GV after discharge and hypoglycemia were lower in group 1 compared with group 2. ","['patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome', 'Thirteen patients were included', 'type 2 diabetes mellitus and acute coronary syndrome']","['glargine', 'liraglutide', 'Liraglutide', 'glucagon-like peptide-1 analogue liraglutide', 'insulin glargine']","['GV determined by CV and SD', 'GV after discharge and hypoglycemia', 'Glycemic variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",13.0,0.0629473,"GV after discharge and hypoglycemia were lower in group 1 compared with group 2. ","[{'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Del Olmo-García', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás Marín', 'Affiliation': 'Unidad Bioestadistica, Instituto de Investigación Sanitaria IIS La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Caudet Esteban', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ballesteros Martin-Portugués', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Cerveró Rubio', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Arnau Vives', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Catalá Gregori', 'Affiliation': 'Unidad Mixta Investigacion Endocrinología, Nutrición y Dietética, IIS La Fe, Valenciana, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Penalba Martínez', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Merino-Torres', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}]",The Journal of international medical research,['10.1177/0300060520926063'] 2100,32567438,Brief Cycles of Lower Limb Occlusion Accelerates Recovery Kinetics In Soccer Players.,"The aim of this study was to assess the effect of intermittent vascular occlusion (IVO) on recovery following simulated soccer physical demand test in soccer players. Twelve soccer players completed the Loughborough Intermittent Shuttle Test (LIST) in two conditions placebo (PLA) and IVO followed by intermittent lower limb occlusion. Physical performance (Squat jump: SJ, countermovement jump: CMJ, maximal voluntary contraction: MVC, and 20 meters sprint: SP), muscle damage parameters (creatine kinase: CK, Lactate dehydrogenase: LDH), inflammatory parameter (C-reactive protein: CRP) and perceived muscle soreness (DOMS) were assessed before, immediately after (0h), and 24h, 48h and 72h following the exercise. Following the LIST, a decrease was observed in all Physical performance within 48h in PLA condition (p<0.05),compared to PLA treatment, IVO treatment attenuated the decrease of SJ and CMJ at 24h and at 48hand for MVC and SP within 48h after the LIST (p<0.05). CK and LDH levels increased within 24h post exercise in both conditions (p<0.05), but with a lower level in IVO compared to PLA condition (p<0.05). Likewise, DOMS values were significantly lower with IVO condition compared to PLA condition immediately and at 24hafter exercise. The results of the present study suggest that the application of IVO after simulated soccer physical demand test accelerated recovery kinetics in soccer players.",2020,"CK and LDH levels increased within 24h post exercise in both conditions (p<0.05), but with a lower level in IVO compared to PLA condition (p<0.05).","['Twelve soccer players completed the', 'soccer players']","['Loughborough Intermittent Shuttle Test (LIST) in two conditions placebo (PLA) and IVO followed by intermittent lower limb occlusion', 'intermittent vascular occlusion (IVO']","['Likewise, DOMS values', 'SJ and CMJ', 'CK and LDH levels', 'Physical performance (Squat jump: SJ, countermovement jump: CMJ, maximal voluntary contraction: MVC, and 20 meters sprint: SP), muscle damage parameters (creatine kinase: CK, Lactate dehydrogenase: LDH), inflammatory parameter (C-reactive protein: CRP) and perceived muscle soreness (DOMS', 'Physical performance']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",,0.0603503,"CK and LDH levels increased within 24h post exercise in both conditions (p<0.05), but with a lower level in IVO compared to PLA condition (p<0.05).","[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Daab', 'Affiliation': 'UR15JS01: Education, Motricité, Sport et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'UR15JS01: Education, Motricité, Sport et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Lajri', 'Affiliation': 'UR15JS01: Education, Motricité, Sport et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Tunisia.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bouchiba', 'Affiliation': 'UR15JS01: Education, Motricité, Sport et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'UR15JS01: Education, Motricité, Sport et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Tunisia.'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1785260'] 2101,32567679,Fitness and strength responses to distinct exercise modes in twins: Studies of Twin Responses to Understand Exercise as a THerapy (STRUETH) study.,"KEY POINTS 495·Exercise is considered medicine, however the individual degree of responsiveness to a standardised dose of exercise is idiosyncratic. 495·Individual responsiveness between distinct exercise modalities and the genetic/environmental contributions to exercise response are not well understood. 495·In this novel randomised cross-over design study, monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training, separated by a 3 month washout period, to assess training responses in strength and fitness outcomes to dichotomous training modalities, and the genetic/environmental contributions to exercise response. 495·Our findings indicate that 1). individual responsiveness differs between exercise modalities; 2). low-responders to one mode may be ""rescued"" by switching to an alternate mode of exercise; and 3) genes may not play as large a role, as previously estimated from cross-sectional data, for exercise training adaptation. 495·This study has implications for those charged with optimising the benefits of exercise by means of individualising the exercise prescription. ABSTRACT Exercise response is idiosyncratic, but the degree of responsiveness, concordance in response between modalities and genetic contribution to responsiveness are not well understood. We investigated this using a novel randomised cross-over design of dichotomous exercise interventions in mono-(MZ) and di-zygotic (DZ) twin pairs. We studied strength (1RM) and fitness (VO 2 max) responses in 84 same-sex untrained twins (30MZ, 12DZ pairs; 24.9 ± 5.4 yr). Twins, as pairs, underwent 3 months of resistance (RES) and endurance (END) training, separated by a 3 month washout period. Training responses and genetic/environmental contributions to responses were assessed. Leg strength 1RM increased following RES but not END (△47 ± 29vs3±26 kg; P < 0.001), whilst VO 2 max increased following END but not RES (△0.25 ± 0.26vs0.04 ± 0.25L.min -1 ; P < 0.001). A higher percentage of individuals responded to RES for strength and to END for VO 2 max (P < 0.0001). Within-individual responses to each mode weren't correlated (P > 0.05). Cross-sectional intraclass correlations were higher for MZ than DZ pairs for all variables, due largely to shared environment. Following training, MZ, but not DZ pairs, were significantly correlated for strength change to RES (rMZ = 0.62, P = 0.002) and END (rMZ = 0.36, P = 0.04), and VO 2 max change to END (L.min -1 , rMZ = 0.45, P = 0.02) with a mixture of unshared/shared environmental contributions. Our findings indicate that individual responsiveness differs between modalities and low-responders to one mode may be ""rescued"" by switching to an alternate mode. Additionally, genes may not play as large a role as previously estimated from cross-sectional data for training adaptation, and/or that cross-sectional data do not reflect longitudinal training effects. This study has implications for optimising the individualisation of exercise prescription. This article is protected by copyright. All rights reserved.",2020,A higher percentage of individuals responded to RES for strength and to END for VO 2 max (P < 0.0001).,"['84 same-sex untrained twins (30MZ, 12DZ pairs; 24.9\xa0±\xa05.4\xa0yr', 'mono-(MZ) and di-zygotic (DZ) twin pairs', 'monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training', 'twins']","['495·In', 'dichotomous exercise interventions']","['Leg strength 1RM', 'resistance (RES) and endurance (END) training', 'strength change to RES', 'strength (1RM) and fitness (VO 2 max) responses']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0041429', 'cui_str': 'Fraternal twin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0319865,A higher percentage of individuals responded to RES for strength and to END for VO 2 max (P < 0.0001).,"[{'ForeName': 'Channa E', 'Initials': 'CE', 'LastName': 'Marsh', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Thomas', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Scurrah', 'Affiliation': 'Twins Research Australia, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, Western Australia, Australia.'}]",The Journal of physiology,['10.1113/JP280048'] 2102,32567682,How mathematics anxiety affects students' inflexible perseverance in mathematics problem-solving: Examining the mediating role of cognitive reflection.,"BACKGROUND Too many students persevere in relying upon one (sometimes suboptimal) strategy for solving a wide range of problems, even when they know more efficient strategies. Although many studies have mentioned such phenomena, few studies have examined how emotional factors could affect this type of inflexible perseverance in strategy use. AIMS To examine whether mathematics anxiety could affect students' inflexible perseverance in strategy use and whether this effect could be mediated by cognitive reflection, which is the ability to engage in deliberate reasoning. SAMPLE AND METHOD In Study 1, 164 undergraduate students' (18-22 years) mathematics anxiety, cognitive reflection, and performance in overcoming inflexible perseverance were measured by a questionnaire battery. Structural equation models were used to examine the correlations between these variables. In Study 2, 98 undergraduate freshmen (17-18 years) were assigned to two groups, where one group's mathematics anxiety was temporarily induced by task instructions, while the other group served as a control group. Cognitive reflection and inflexible perseverance of the two groups were compared. RESULTS Study 1 showed that mathematics anxiety was negatively correlated with students' performance on overcoming inflexible perseverance, while cognitive reflection mediated such an effect. Study 2 showed that compared to the control group, the experimental group showed lower cognitive reflection, which led to lower performance in overcoming inflexible perseverance. CONCLUSIONS Mathematics anxiety was showed to impair students' ability to engage in deliberate reasoning and was associated with inflexible use of strategies. Alleviating students' mathematics anxiety should be considered when promoting students' strategic flexibility.",2020,"RESULTS Study 1 showed that mathematics anxiety was negatively correlated with students' performance on overcoming inflexible perseverance, while cognitive reflection mediated such an effect.","['98 undergraduate freshmen (17-18\xa0years', ""164 undergraduate students' (18-22\xa0years""]",[],"['lower cognitive reflection', 'Cognitive reflection and inflexible perseverance', 'mathematics anxiety', 'mathematics anxiety, cognitive reflection, and performance in overcoming inflexible perseverance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0327448,"RESULTS Study 1 showed that mathematics anxiety was negatively correlated with students' performance on overcoming inflexible perseverance, while cognitive reflection mediated such an effect.","[{'ForeName': 'Ronghuan', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Psychology, Beijing Normal University, China.'}, {'ForeName': 'Ru-de', 'Initials': 'RD', 'LastName': 'Liu', 'Affiliation': 'Faculty of Psychology, Beijing Normal University, China.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Star', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhen', 'Affiliation': 'Institute of Psychological Science, Hangzhou Normal University, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Teachers' College, Beijing Union University, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': 'Faculty of Psychology, Beijing Normal University, China.'}, {'ForeName': 'Shuyang', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Psychology, Beijing Normal University, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Faculty of Psychology, Beijing Normal University, China.'}, {'ForeName': 'Xinchen', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Faculty of Psychology, Beijing Normal University, China.'}]",The British journal of educational psychology,['10.1111/bjep.12364'] 2103,32567708,Challenging the role of challenge in intensive short-term dynamic psychotherapy for social anxiety disorder: A randomized controlled trial.,"OBJECTIVES Intensive short-term dynamic psychotherapy (ISTDP) requires the technique of challenge to defenses when treating resistant patients. As the technique of challenge is difficult for some therapists to practice, it leads us to question whether challenge can be replaced by clarification of defenses without losing treatment effectiveness. This study compared ISTDP with two different technical emphases while treating social anxiety disorder (SAD). METHOD Forty-two subjects with DSM-5 SAD were randomly assigned to either a waitlist control, 10 sessions of ISTDP with the use of challenge or 10 sessions of ISTDP without the use of challenge. RESULTS ISTDP led to significant, sustained symptom reduction on the Liebowitz Social Anxiety Scale (LSAS-SR) compared with the control group. There were no significant outcome differences between standard ISTDP and ISTDP where challenge was restricted. CONCLUSION ISTDP is efficacious for SAD. ISTDP may be effective for SAD without the use of challenge elements.",2020,"RESULTS ISTDP led to significant, sustained symptom reduction on the Liebowitz Social Anxiety Scale (LSAS-SR) compared with the control group.","['Forty-two subjects with DSM-5 SAD', 'social anxiety disorder']","['ISTDP', 'Intensive short-term dynamic psychotherapy (ISTDP', 'intensive short-term dynamic psychotherapy']","['Liebowitz Social Anxiety Scale (LSAS-SR', 'social anxiety disorder (SAD']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023652', 'cui_str': 'Lichen sclerosus et atrophicus'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",42.0,0.0169634,"RESULTS ISTDP led to significant, sustained symptom reduction on the Liebowitz Social Anxiety Scale (LSAS-SR) compared with the control group.","[{'ForeName': 'Fateh', 'Initials': 'F', 'LastName': 'Rahmani', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Centre for Emotions and Health, Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Azad', 'Initials': 'A', 'LastName': 'Hemmati', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Ghaffari', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Rezaei Mirghaed', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}]",Journal of clinical psychology,['10.1002/jclp.22993'] 2104,32567734,"Efficacy and safety of oral tranexamic acid as an adjuvant in Indian patients with melasma: a prospective, interventional, single-centre, triple-blind, randomized, placebo-control, parallel group study.","BACKGROUND Melasma is a chronic recalcitrant pigmentary disorder whose treatment frustrates physician and patient alike. Tranexamic acid, a plasmin inhibitor, has demonstrated hypopigmenting properties. AIM To compare safety and efficacy of combination of oral tranexamic acid (TXA) and topical fluocinolone-based combination cream (FbTC) with that of topical FbTC alone in melasma. METHOD One hundred and eighty patients patients of facial melasma of either sex attending dermatology OPD were screened. Consenting 130 participants were randomized into two blinded groups with 65 patients in each group. Group A patients received oral tranexamic acid 250 mg and oral ranitidine 150 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05% and hydroquinone 2% once daily, and Group B was asked to take placebo tablets (calcium lactate and multivitamin) and apply the cream only for 12 weeks. Response was evaluated using modified melasma area severity index (mMASI) and graded mMASI improvement at 4th, 8th and 12th weeks, and at 24th week for recurrence. Data were analysed using SPSS software. RESULTS Results were analysed in 120 patients who completed the study with 61 and 59 patients in group A and B, respectively. Demographic profile was equally distributed in both the groups. In group A, 13.1% patients showed marked improvement (>75%) in mMASI as compared to group B (1.7%) at 4th week. By 12th week, 65.6% patients had marked improvement in group A in contrast to only 27.1% in group B. At 24th week, group A (65.6%) had sustained improvement as compared to group B (11.9%) despite stopping treatment; all of which were statistically significant. Recurrence observed was 18.03% in group A vs. 64.4% in group B at 24th week. CONCLUSION Oral tranexamic acid is definitely a boon to the armamentarium of melasma management and should be used as an adjuvant to fluocinolone-based triple combination cream for a faster, sustained improvement and to prevent recurrence.",2020,"Recurrence observed was 18.03% in group A vs. 64.4% in group B at 24th week. ","['Indian patients with melasma', 'One hundred and eighty patients patients of facial melasma of either sex attending dermatology OPD were screened', 'Consenting 130 participants', 'melasma', '120 patients who completed the study with 61 and 59 patients in group A and B, respectively']","['placebo tablets (calcium lactate and multivitamin', 'Oral tranexamic acid', 'Tranexamic acid, a plasmin inhibitor', 'fluocinolone acetonide 0.01%, tretinoin 0.05% and hydroquinone', 'topical FbTC alone', 'oral tranexamic acid 250\xa0mg and oral ranitidine', 'oral tranexamic acid (TXA) and topical fluocinolone-based combination cream (FbTC', 'fluocinolone', 'oral tranexamic acid', 'placebo']","['modified melasma area severity index (mMASI) and graded mMASI improvement', 'Recurrence', 'Demographic profile', 'Efficacy and safety', 'safety and efficacy']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0108121', 'cui_str': 'calcium lactate'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032139', 'cui_str': 'Plasmin inhibitor'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0060507', 'cui_str': 'fluocinolone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0034665', 'cui_str': 'Ranitidine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",130.0,0.0438496,"Recurrence observed was 18.03% in group A vs. 64.4% in group B at 24th week. ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Minni', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, K.J. Somaiya Medical College and Research Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Poojary', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, K.J. Somaiya Medical College and Research Centre, Mumbai, Maharashtra, India.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16598'] 2105,32567789,Patient satisfaction with random assignment to extended early intervention for psychosis vs regular care: Relationship with service engagement.,"AIM We investigated whether individuals varied in their satisfaction with being randomized to an extension of early intervention (EI) for psychosis or regular care after 2 years of EI, and whether satisfaction was associated with service engagement 3 years later. METHODS Following randomization, patients (N = 220) indicated if they were happy with, unhappy or indifferent to their group assignment. Follow-up with service providers was recorded monthly. RESULTS Patients randomized to extended EI were more likely to express satisfaction with their group assignment than those in the regular care group (88.2% vs 31.5%, χ 2 = 49.96, P < .001). In the extended EI group, those happy with their assigned group were likelier to continue seeing their case manager for the entire five-year period than those who were unhappy/indifferent (χ 2 = 5.61, P = .030). CONCLUSIONS Perceptions about EI, indicated by satisfaction with being assigned to extended EI, may have lasting effects on service engagement.",2020,"RESULTS Patients randomized to extended EI were more likely to express satisfaction with their group assignment than those in the regular care group (88.2% vs 31.5%, χ 2 = 49.96, P < .001).","['Following randomization, patients (N = 220) indicated if they were happy with, unhappy or indifferent to their group assignment']",['extension of early intervention (EI'],[],"[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1688635', 'cui_str': 'Feeling unhappy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]",[],,0.0907587,"RESULTS Patients randomized to extended EI were more likely to express satisfaction with their group assignment than those in the regular care group (88.2% vs 31.5%, χ 2 = 49.96, P < .001).","[{'ForeName': 'Srividya N', 'Initials': 'SN', 'LastName': 'Iyer', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Sally S', 'Initials': 'SS', 'LastName': 'Mustafa', 'Affiliation': 'Prevention and Early Intervention Program for Psychosis (PEPP), Douglas Mental Health University Institute, Quebec, Canada.'}, {'ForeName': 'Sherezad', 'Initials': 'S', 'LastName': 'Abadi', 'Affiliation': 'Douglas Mental Health University Institute, Quebec, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Abdel-Baki', 'Affiliation': ""Department of Psychiatry, University of Montreal, Centre hospitalier de l'Université de Montréal, Quebec, Canada.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jarvis', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Latimer', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Margolese', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Casacalenda', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Malla', 'Affiliation': 'Department of Psychiatry, McGill University, Quebec, Canada.'}]",Early intervention in psychiatry,['10.1111/eip.13004'] 2106,32568096,Effect of Preloading With High Dose of Rosuvastatin on Serum Levels of Inflammatory Markers After Percutaneous Coronary Intervention.,"OBJECTIVES We sought to assess the effects of a high loading dose of rosuvastatin (40 mg) on acute inflammatory response after coronary stenting. METHODS Patients with stable coronary disease without statin use (≥7 days) and undergoing elective percutaneous coronary intervention (PCI) in a native coronary artery were randomized to receive a loading dose of rosuvastatin (n = 64) or not (n = 61). Blood samples were obtained before statin intake (time point A), 3 hours after medication (time point B), and 3 hours after PCI (time point C). The primary goal was the comparison in the variation of the serum inflammatory markers and their gene expression at the different time points between the two groups. RESULTS Baseline clinical, angiographic, and procedural characteristics did not significantly differ between the groups, except for the more frequent use of postdilation in the control group (73.4% vs 90.2%; P=.02). Patients pretreated with statin showed a reduction in the serum levels of interleukin (IL)-1β (Δ = -0.491 pg/mL; Pinteraction<.001), IL-6 (Δ = -0.209 pg/mL; Pinteraction<.001), and plasminogen activator inhibitor 1 (Δ = -1.573 pg/mL; Pinteraction<.001) as well as in their genetic expression, which was not observed in the control group. Regarding high-sensitivity c-reactive protein, there was no significant variation in its value from time point A to C in patients pretreated with statin (P=.58) while it significantly increased in the control group (P=.04). CONCLUSIONS Among patients with stable coronary artery disease undergoing PCI with stents, pretreatment with high dose of rosuvastatin resulted in significant reduction in the serum levels of important inflammatory markers and their genetic expression.",2020,"Patients pretreated with statin showed a reduction in the serum levels of interleukin (IL)-1β (Δ = -0.491 pg/mL; Pinteraction<.001), IL-6","['patients with stable coronary artery disease undergoing PCI with stents', 'Patients with stable coronary disease without statin use (≥7 days) and undergoing elective percutaneous coronary intervention (PCI) in a native coronary artery']","['plasminogen activator inhibitor 1', 'rosuvastatin', 'statin', 'Rosuvastatin']","['serum levels of important inflammatory markers and their genetic expression', 'serum inflammatory markers and their gene expression', 'IL-6', 'acute inflammatory response', 'Serum Levels of Inflammatory Markers', 'serum levels of interleukin (IL)-1β']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.0790185,"Patients pretreated with statin showed a reduction in the serum levels of interleukin (IL)-1β (Δ = -0.491 pg/mL; Pinteraction<.001), IL-6","[{'ForeName': 'Juliano R', 'Initials': 'JR', 'LastName': 'Slhessarenko', 'Affiliation': 'Av. Dr. Dante Pazzanese, 500-Vila Mariana, São Paulo, SP, Brasil, CEP 04012-180. jjjrsmed@hotmail.com.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Hirata', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sousa', 'Affiliation': ''}, {'ForeName': 'Gisele M', 'Initials': 'GM', 'LastName': 'Bastos', 'Affiliation': ''}, {'ForeName': 'Elisa M S', 'Initials': 'EMS', 'LastName': 'Higa', 'Affiliation': ''}, {'ForeName': 'Margareth G', 'Initials': 'MG', 'LastName': 'Mouro', 'Affiliation': ''}, {'ForeName': 'Guilherme C', 'Initials': 'GC', 'LastName': 'Sobrera', 'Affiliation': ''}, {'ForeName': 'Renata D', 'Initials': 'RD', 'LastName': 'Slhessarenko', 'Affiliation': ''}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Viana', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Abizaid', 'Affiliation': ''}, {'ForeName': 'J Ribamar', 'Initials': 'JR', 'LastName': 'Costa', 'Affiliation': ''}]",The Journal of invasive cardiology,[] 2107,32568108,Carbidopa and Levodopa Extended Release Capsules (Rytary®) in Patients with and without Troublesome and Non-Troublesome Dyskinesia.,"BACKGROUND Carbidopa (CD) and levodopa (LD) extended release (CD-LD ER, Rytary®) capsules are designed to combine both immediate and extended release pharmacokinetics. In the phase 3, randomized, double-blind, ADVANCE-PD trial, patients randomized to CD-LD ER experienced a 1.17-hour greater reduction in OFF time compared to patients randomized to CD-LD IR (p < 0.0001). OBJECTIVE To compare CD-LD IR optimization to CD-LD ER conversion based on patient dyskinesia status at baseline using data from the ADVANCE-PD trial. METHODS This was a retrospective analysis of the ADVANCE-PD study. Patients were categorized by dyskinesia status at baseline into 1) those who had No Dyskinesia (ND), 2) those who had Non-Troublesome Dyskinesia Only (NTDO), and 3) those who had Troublesome Dyskinesia (TD). RESULTS Comparative reductions in OFF time favoring CD-LD ER over CD-LD IR were similar for the ND (-1.08 h, p = 0.0071, n = 183) and NTDO (-1.12 h, p = 0.0104, n = 131) groups, and smaller for the TD group (-0.82 h, p = 0.2382, n = 79). Reductions in OFF time for both CD-LD ER conversion and CD-LD IR adjustment were largest within the ND group and smallest within the TD group (CD-LD ER: ND -2.86 h, NTDO -2.11 h, TD -1.36 h; CD-LD IR: ND -1.78 h, NTDO -0.99 h, TD -0.55 h). CONCLUSION Responses to both CD-LD IR adjustment and CD-LD ER conversion depended on baseline dyskinesia status. Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups. In the TD group, comparing CD-LD ER conversion to CD-LD IR optimization, benefits were still observed, but there was less reduction in OFF time, less reduction in troublesome dyskinesia, and fewer patients self-rated themselves much or very much improved than in the ND and NTDO groups. These data suggest that in clinical practice, the best chances for success with conversion from CD-LD IR to CD-LD ER are in patients without TD.",2020,Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups.,"['Patients were categorized by dyskinesia status at baseline into 1) those who had No Dyskinesia (ND), 2) those who had Non-Troublesome Dyskinesia', 'Patients with and without Troublesome and Non-Troublesome Dyskinesia']","['CD-LD IR adjustment and CD-LD ER conversion', 'ND', 'Carbidopa (CD) and levodopa (LD) extended release (CD-LD ER, Rytary®) capsules', 'CD-LD IR optimization to CD-LD ER conversion', 'CD-LD ER', 'Carbidopa and Levodopa Extended Release Capsules (Rytary®']","['troublesome dyskinesia', 'CD-LD IR', 'OFF time', 'OFF time favoring CD-LD ER over CD-LD IR', 'Troublesome Dyskinesia (TD', 'OFF time for both CD-LD ER conversion and CD-LD IR adjustment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C3872096', 'cui_str': 'Rytary'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",,0.017814,Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Zeitlin', 'Affiliation': 'Quartesian, Princeton, NJ, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'Amneal Pharmaceuticals, Bridgewater, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""D'Souza"", 'Affiliation': 'Amneal Pharmaceuticals, Bridgewater, NJ, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-202010'] 2108,32568111,Optimizing Treatment in Undertreated Late-Stage Parkinsonism: A Pragmatic Randomized Trial.,"BACKGROUND Treatment of patients with late-stage parkinsonism is often sub-optimal. OBJECTIVE To test the effectiveness of recommendations by a movement disorder specialist with expertise in late-stage parkinsonism. METHODS Ninety-one patients with late-stage parkinsonism considered undertreated were included in apragmatic multi-center randomized-controlled trial with six-month follow-up. The intervention group received a letter with treatment recommendations to their primary clinician based on an extensive clinical assessment. Controls received care as usual. The primary outcome was the Unified Parkinson Disease Rating Scale (UPDRS)part-II (Activities of Daily Living).Other outcomes included quality-of-life (PDQ-8), mental health (UPDRS-I), motor function (UPDRS-III), treatment complications (UPDRS-IV), cognition (Mini-mental-state-examination), non-motor symptoms (Non-Motor-Symptoms-scale), health status (EQ-5D-5L) and levodopa-equivalent-daily-dose (LEDD). We also assessed adherence to recommendations. In addition to intention-to-treat analyses, aper-protocol analysis was conducted. RESULTS Sample size calculation required 288 patients, but only 91 patients could be included. Treating physicians followed recommendations at least partially in 37(64%) patients. The intention-to-treat analysis showed no difference in primary outcome (between-group difference = -1.2, p = 0.45), but there was greater improvement for PDQ-8 in the intervention group (between-group difference = -3.7, p = 0.02). The per-protocol analysis confirmed these findings, and showed less deterioration in UPDRS-part I, greater improvement on UPDRS-total score and greater increase in LEDD in the intervention group. CONCLUSIONS The findings suggest that therapeutic gains may be reached even in this vulnerable group of patients with late-stage parkinsonism, but also emphasize the need for better strategies to implement specialist recommendations to further improve outcomes.",2020,"The intention-to-treat analysis showed no difference in primary outcome (between-group difference = -1.2, p = 0.45), but there was greater improvement for PDQ-8 in the intervention group (between-group difference = -3.7, p = 0.02).","['patients with late-stage parkinsonism', 'Ninety-one patients with late-stage parkinsonism considered undertreated were included in apragmatic multi-center randomized-controlled trial with six-month follow-up', 'Undertreated Late-Stage Parkinsonism']",['letter with treatment recommendations to their primary clinician based on an extensive clinical assessment'],"['Unified Parkinson Disease Rating Scale (UPDRS)part-II (Activities of Daily Living).Other outcomes included quality-of-life (PDQ-8), mental health (UPDRS-I), motor function (UPDRS-III), treatment complications (UPDRS-IV), cognition (Mini-mental-state-examination), non-motor symptoms (Non-Motor-Symptoms-scale), health status (EQ-5D-5L) and levodopa-equivalent-daily-dose (LEDD', 'PDQ-8', 'UPDRS-total score', 'LEDD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",91.0,0.170072,"The intention-to-treat analysis showed no difference in primary outcome (between-group difference = -1.2, p = 0.45), but there was greater improvement for PDQ-8 in the intervention group (between-group difference = -3.7, p = 0.02).","[{'ForeName': 'Adrianus L A J', 'Initials': 'ALAJ', 'LastName': 'Hommel', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Nijmegen, The Netherlands; Groenhuysen Organisation, Roosendaal, the Netherlands.'}, {'ForeName': 'Marjan J', 'Initials': 'MJ', 'LastName': 'Meinders', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Scientici Center for Quality of Healthcare, Nijmegen, the Netherlands.'}, {'ForeName': 'Nico J', 'Initials': 'NJ', 'LastName': 'Weerkamp', 'Affiliation': 'Department of Neurology, Bronovo Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Richinger', 'Affiliation': 'Interdisziplinäres Zentrum für Palliativmedizin und Klinik für Neurologie Universität München - Klinikum Großhadern, Munich, Germany. Institute of Nursing Science and -Practice, Paracelsus Medical University Salzburg, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmotz', 'Affiliation': 'Interdisziplinäres Zentrum für Palliativmedizin und Klinik für Neurologie Universität München - Klinikum Großhadern, Munich, Germany. Institute of Nursing Science and -Practice, Paracelsus Medical University Salzburg, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lorenzl', 'Affiliation': 'Interdisziplinäres Zentrum für Palliativmedizin und Klinik für Neurologie Universität München - Klinikum Großhadern, Munich, Germany. Institute of Nursing Science and -Practice, Paracelsus Medical University Salzburg, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dodel', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Coelho', 'Affiliation': 'Instituto de Medicina Molecular Universidad di Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Joaquim J', 'Initials': 'JJ', 'LastName': 'Ferreira', 'Affiliation': 'Instituto de Medicina Molecular Universidad di Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Tison', 'Affiliation': 'Service de Neurologie, CHU de Bordeaux, Bordeaux, France and Univ. de Bordeaux, Institut des Maladies Neurodégénératives, CNRS, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boraud', 'Affiliation': 'Service de Neurologie, CHU de Bordeaux, Bordeaux, France and Univ. de Bordeaux, Institut des Maladies Neurodégénératives, CNRS, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Wassilios G', 'Initials': 'WG', 'LastName': 'Meissner', 'Affiliation': 'Service de Neurologie, CHU de Bordeaux, Bordeaux, France and Univ. de Bordeaux, Institut des Maladies Neurodégénératives, CNRS, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Rosqvist', 'Affiliation': 'Department of Clinical Sciences, Division of Neurology, Lund University, Lund, Sweden.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Timpka', 'Affiliation': 'Department of Clinical Sciences, Division of Neurology, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Odin', 'Affiliation': 'Department of Clinical Sciences, Division of Neurology, Lund University, Lund, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wittenberg', 'Affiliation': 'Coordinating Centre for Clinical Trials (KKS), Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Bas R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behavior, Department of Neurology, Nijmegen, The Netherlands.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Koopmans', 'Affiliation': 'Radboud University Medical Center, Department of Primary and Community Care, Nijmegen, The Netherlands; Joachim en Anna, Center for Specialized Geriatric Care, Nijmegen, The Netherlands.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Schragand', 'Affiliation': 'UCL Queen Square Institute of Neurology, University College London, Royal Free Campus, Rowland Hill Street, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Parkinson's disease,['10.3233/JPD-202033'] 2109,32568134,"Effect of positive end-expiratory pressure ventilation on plasma nitric oxide, endothelin-1 and vascular celladhesion molecule-1 levels in patients undergoing uvulopalatopharyngoplasty.","BACKGROUND During uvulopalatopharyngoplasty (UPPP), cardiovascular adverse events may occur which can be harmful to patients. OBJECTIVE To evaluate the effect of the protective ventilation strategy on the function of vascular endothelial cells. METHODS Forty obstructive apnea syndrome (OSA) patients who underwent uvulopalatopharyngoplasty (UPPP) were enrolled. Patients were randomly divided into the control group (group C, PEEP = 0 cm H2O) and PEEP group (group P, PEEP = 5 cm H2O). Each group (n= 20) received intermittent volume controlled ventilation (VCV) with tidal volume 6 ml/kg of the predicted body weight, I:E 1:2, rate titrated for ETCO2 35-45, FiO2 0.7. Blood from the radial artery was sampled for blood gas analysis at four time points: the fifth minute of inhaling pure oxygen (T0), after tracheal intubation (T1), at the end of the operation (T2), and 20 minutes after extubation (T3). Three ml of arterial blood was retained, preserved at -20∘C after serum isolation, and plasma nitric oxide (NO), endothelin-1 (ET-1) and vascular celladhesion molecule-1 (VCAM-1) levels were determined by enzyme linked immunosorbent assay (ELISA). RESULTS Compared with group C, plasma ET-1 at T3 decreased in group P, and plasma NO levels at T2 and T3 increased (P< 0.05). Compared with samples collected at T0, plasma VCAM-1 levels at T1, T2 and T3 increased in group C, while plasma VCAM-1 levels at T1, T2 and T3 decreased in group P (P< 0.05). Compared with group C, plasma VCAM-1 levels T2 and T3 decreased in group P (P< 0.05). CONCLUSIONS Positive end-expiratory pressure (PEEP) ventilation has a protective effect on vascular endothelial cell function in patients during UPPP.",2020,"Compared with group C, plasma VCAM-1 levels T2 and T3 decreased in group P (P< 0.05). ","['patients undergoing uvulopalatopharyngoplasty', 'patients during UPPP', 'Forty obstructive apnea syndrome (OSA) patients who underwent']","['uvulopalatopharyngoplasty (UPPP', 'PEEP', 'positive end-expiratory pressure ventilation', 'intermittent volume controlled ventilation (VCV', 'protective ventilation strategy', 'Positive end-expiratory pressure (PEEP) ventilation']","['plasma ET-1', 'plasma VCAM-1 levels', 'plasma NO levels', 'plasma nitric oxide, endothelin-1 and vascular celladhesion molecule-1 levels', 'plasma VCAM-1 levels T2 and T3', 'vascular endothelial cell function', 'plasma nitric oxide (NO), endothelin-1 (ET-1) and vascular celladhesion molecule-1 (VCAM-1) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C1257792', 'cui_str': 'Vascular Endothelial Cells'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",40.0,0.120777,"Compared with group C, plasma VCAM-1 levels T2 and T3 decreased in group P (P< 0.05). ","[{'ForeName': 'Yi-Ri', 'Initials': 'YR', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Jian-She', 'Initials': 'JS', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Na-Ri', 'Initials': 'NR', 'LastName': 'Wu-Lan', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': ''}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Zhong', 'Affiliation': ''}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-202193'] 2110,32565465,"Study protocol for the safety and efficacy of probiotic therapy on days alive and out of hospital in adult ICU patients: the multicentre, randomised, placebo-controlled Restoration Of gut microflora in Critical Illness Trial (ROCIT).","INTRODUCTION The effect of early and sustained administration of daily probiotic therapy on patients admitted to the intensive care unit (ICU) remains uncertain. METHODS AND ANALYSIS The Restoration Of gut microflora in Critical Illness Trial (ROCIT) study is a multicentre, randomised, placebo-controlled, parallel-group, two-sided superiority trial that will enrol 220 patients in five ICUs. Adult patients who are within 48 hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained Lactobacillus plantarum 299v probiotic therapy in addition to usual care or placebo in addition to usual care. The primary endpoint is days alive and out of hospital to day 60. ETHICS AND DISSEMINATION ROCIT has been approved by the South Metropolitan Health Service Human Research Ethics Committee (ref: RGS00000004) and the St John of God Health Care Human Research Ethics Committee (ref: 1183). The trial results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER Australian and New Zealand Clinical Trials Registry (ANZCTR12617000783325); Pre-results.",2020,The Restoration Of gut microflora in Critical Illness Trial,"['patients admitted to the intensive care unit (ICU', 'Australian and New Zealand', 'days alive and out of hospital in adult ICU patients', 'Adult patients who are within 48\u2009hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained', 'enrol 220 patients in five ICUs']","['Lactobacillus plantarum 299v probiotic therapy', 'probiotic therapy', 'daily probiotic therapy', 'placebo']",['days alive and out of hospital to day 60'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.364712,The Restoration Of gut microflora in Critical Illness Trial,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia ed.litton@health.wa.gov.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Anstey', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Broadhurst', 'Affiliation': 'School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Andy R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Currie', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ferrier', 'Affiliation': 'Intensive Care Unit, St John of God Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gummer', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Orr', 'Affiliation': 'Pharmacy, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Palermo', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Paparini', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pellicano', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Raby', 'Affiliation': 'Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Rammohan', 'Affiliation': 'Department of Economics, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Regli', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Richter', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Salman', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Strunk', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Waterson', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wibrow', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035930'] 2111,32565467,Getting evidence into clinical practice: protocol for evaluation of the implementation of a home-based cardiac rehabilitation programme for patients with heart failure.,"INTRODUCTION Cardiac rehabilitation (CR) improves health-related quality of life and reduces hospital admissions. However, patients with heart failure (HF) often fail to attend centre-based CR programmes. Novel ways of delivering healthcare, such as home-based CR programmes, may improve uptake of CR. Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a new, effective and cost-effective home-based CR programme for people with HF. The aim of this prospective mixed-method implementation evaluation study is to assess the implementation of the REACH-HF CR programme in the UK National Health Service (NHS). The specific objectives are to (1) explore NHS staff perceptions of the barriers and facilitators to the implementation of REACH-HF, (2) assess the quality of delivery of the programme in real-life clinical settings, (3) consider the nature of any adaptation(s) made and how they might impact on intervention effectiveness and (4) compare real-world patient outcomes to those seen in a prior clinical trial. METHODS AND ANALYSIS REACH-HF will be rolled out in four NHS CR centres across the UK. Three healthcare professionals from each site will be trained to deliver the 12-week programme. In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme. Consultations for 48 patients (12 per site) will be audio recorded and scored using an intervention fidelity checklist. Outcomes routinely recorded in the National Audit of Cardiac Rehabilitation will be analysed and compared with outcomes from a recent randomised controlled trial: the Minnesota Living with HF Questionnaire and exercise capacity (Incremental Shuttle Walk Test). Qualitative research findings will be mapped onto the Normalisation Process Theory framework and presented in the form of a narrative synthesis. Results of the study will inform national roll-out of REACH-HF. ETHICS AND DISSEMINATION The study (IRAS 261723) has received ethics approval from the South Central (Hampshire B) Research Ethics Committee (19/SC/0304). Written informed consent will be obtained from all health professionals and patients participating in the study. The research team will ensure that the study is conducted in accordance with the Declaration of Helsinki, the Data Protection Act 2018, General Data Protection Regulations and in accordance with the Research Governance Framework for Health and Social Care (2005). Findings will be published in scientific peer-reviewed journals and presented at local, national and international meetings to publicise and explain the research methods and findings to key audiences to facilitate the further uptake of the REACH-HF intervention. TRIAL REGISTRATION ISRCTN86234930.",2020,In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme.,"['people with HF', 'patients with heart failure', 'patients with heart failure (HF', '48 patients (12 per site']","['REACH-HF CR programme', 'Minnesota Living with HF Questionnaire and exercise capacity (Incremental Shuttle Walk Test', 'Cardiac rehabilitation (CR']",['health-related quality of life and reduces hospital admissions'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.10218,In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme.,"[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Daw', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, UK pxd891@student.bham.ac.uk.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'van Beurden', 'Affiliation': 'Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jet J C S', 'Initials': 'JJCS', 'LastName': 'Veldhuijzen van Zanten', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Harrison', 'Affiliation': 'Health Sciences, University of York, York, UK.'}, {'ForeName': 'Hasnain', 'Initials': 'H', 'LastName': 'Dalal', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sinead T J', 'Initials': 'STJ', 'LastName': 'McDonagh', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Doherty', 'Affiliation': 'Health Sciences, University of York, York, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036137'] 2112,32565469,Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial.,"INTRODUCTION The incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment. METHODS ACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes. ETHICS AND DISSEMINATION The trial has approvals from the London-Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020. TRIAL REGISTRATION NUMBER ISRCTN12146519.",2020,"The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all.","['Four large London maternity units', 'women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency', 'women at >24 weeks gestation who are actively bleeding within 24\u2009hours of delivery and for whom transfusion of red blood cells (RBCs) has been started', 'women who develop severe postpartum haemorrhage (ACROBAT) in the UK']",['early cryoprecipitate transfusion versus standard care'],"['Fibrinogen levels', 'feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes', 'severe postpartum haemorrhage (PPH']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0015528', 'cui_str': 'factor XIII'}, {'cui': 'C4316812', 'cui_str': 'Fibrinogen deficiency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]",,0.137309,"The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, UK Laura.Green27@nhs.net.'}, {'ForeName': 'Jahnavi', 'Initials': 'J', 'LastName': 'Daru', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Pardo Llorente', 'Affiliation': 'Department of Statistics and Operational Research, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pérez Pérez', 'Affiliation': 'Department of Statistics and Data Science, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""Department of Women's and Neonatal Health, Royal London Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-036416'] 2113,32565474,Pulse oximeter with integrated management of childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia: results from a cluster-randomised controlled trial.,"OBJECTIVE To assess whether pulse oximetry improves health workers' performance in diagnosing severe childhood pneumonia at health centres in Southern Ethiopia. DESIGN Parallel cluster-randomised trial. SETTING Government primary health centres. PARTICIPANTS Twenty-four health centres that treat at least one pneumonia case per day in Southern Ethiopia. Children aged between 2 months and 59 months who present at health facilities with cough or difficulty breathing were recruited in the study from September 2018 to April 2019. INTERVENTION ARM Use of the Integrated Management of Childhood Illness (IMCI) algorithm and pulse oximeter. CONTROL ARM Use of the IMCI algorithm only. PRIMARY AND SECONDARY OUTCOME MEASURES The primary outcome was the proportion of children diagnosed with severe pneumonia. Secondary outcomes included referred cases of severe pneumonia and treatment failure on day 14 after enrolment. RESULT Twenty-four health centres were randomised into intervention (928 children) and control arms (876 children). The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm. After adjusting for differences in baseline variables children in the intervention arm were more likely to be diagnosed as severe pneumonia cases as compared with those in the control arm (adjusted OR: 5.4, 95% CI 2.0 to 14.3, p=0.001). CONCLUSION The combined use of IMCI and pulse oximetry in health centres increased the number of diagnosed severe childhood pneumonia. TRIAL REGISTRATION NUMBER PACTR201807164196402.",2020,The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm.,"['diagnosing severe childhood pneumonia at health centres in Southern Ethiopia', 'Children aged between 2 months and 59 months who present at health facilities with cough or difficulty breathing were recruited in the study from September 2018 to April 2019', 'Government primary health centres', 'childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia', 'Twenty-four health centres that treat at least one pneumonia case per day in Southern Ethiopia', 'Twenty-four health centres']","['Pulse oximeter with integrated management', 'pulse oximetry', 'IMCI and pulse oximetry', 'ARM\n\n\nUse of the Integrated Management of Childhood Illness (IMCI) algorithm and pulse oximeter']","['referred cases of severe pneumonia and treatment failure on day 14 after enrolment', ""health workers' performance"", 'severe pneumonia cases', 'proportion of children diagnosed with severe pneumonia', 'proportion of children with severe pneumonia']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.256355,The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm.,"[{'ForeName': 'Solomon H', 'Initials': 'SH', 'LastName': 'Tesfaye', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia solomon0917242124@gmail.com.'}, {'ForeName': 'Yabibal', 'Initials': 'Y', 'LastName': 'Gebeyehu', 'Affiliation': 'School of Medicine, Dilla University College of Health Sciences, Dilla, Ethiopia.'}, {'ForeName': 'Eskindir', 'Initials': 'E', 'LastName': 'Loha', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia.'}, {'ForeName': 'Kjell Arne', 'Initials': 'KA', 'LastName': 'Johansson', 'Affiliation': 'Global Public Health and Primary Care, University of Bergen Centre for International Health, Bergen, Norway.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Lindtjørn', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia.'}]",BMJ open,['10.1136/bmjopen-2020-036814'] 2114,32565594,"Comparative evaluation of efficacy and tolerability of vilazodone, escitalopram, and amitriptyline in patients of major depressive disorder: A randomized, parallel, open-label clinical study.","OBJECTIVES To evaluate and compare efficacy and tolerability of Vilazodone with Escitalopram and Amitriptyline in patients of major depressive disorder(MDD). METHODS This was a randomized, prospective, parallel-group, open label clinical study in which newly diagnosed patients of MDD were randomized to receive Tab Vilazodone 20 mg daily or Tab Escitalopram 20mg daily or Tab Amitriptyline 75mg daily for 12 weeks. Antidepressant activity was assessed by change in score from baseline to week 12 on HAMD-17 and MADRS scales while change in score on HAM-A scale was used to assess antianxiety effect. Change in scores on the three scales was also compared between the three treatment groups. Severity and causality of adverse events were assessed by the modified Hartwig & Siegel scale and Naranjo scale respectively. Data was analyzed in accordance with per protocol analysis. RESULTS Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant. Number of remitters were also significantly more in the vilazodone group ( n =11) compared to escitalopram ( n =4) ( p <0.05) and amitriptyline ( n =0) ( p <0.001) at 12 weeks. Similar results were also obtained with HAM-A score. Number of patients showing MADRS sustained response at 12 weeks was statistically significantly more in vilazodone ( n =12) and escitalopram ( n =12) groups compared to amitriptyline ( n =01) ( p <0.001). Reported adverse events were constipation and sedation(amitriptyline group); nausea and headache(escitalopram and vilazodone groups). These adverse events were of mild severity. Most adverse events belonged to probable category. CONCLUSION Vilazodone is more efficacious and well tolerated antidepressant compared to escitalopram and amitriptyline.",2020,"RESULTS Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant.","['newly diagnosed patients of MDD', 'patients of major depressive disorder(MDD', 'patients of major depressive disorder']","['Vilazodone', 'Tab Vilazodone 20 mg daily or Tab Escitalopram 20mg daily or Tab Amitriptyline', 'vilazodone, escitalopram, and amitriptyline', 'Vilazodone with Escitalopram and Amitriptyline', 'amitriptyline', 'vilazodone']","['Antidepressant activity', 'antianxiety effect', 'Severity and causality of adverse events', 'efficacy and tolerability', 'HAMD-17 and MADRS scores', 'Number of remitters', 'MADRS sustained response']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C1530072', 'cui_str': 'vilazodone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1171041', 'cui_str': 'Escitalopram 20 MG'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",,0.0467849,"RESULTS Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant.","[{'ForeName': 'Renuka L', 'Initials': 'RL', 'LastName': 'Kadam', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Smita Dipak', 'Initials': 'SD', 'LastName': 'Sontakke', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Tiple', 'Affiliation': 'Department of Psychiatry, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Vijay M', 'Initials': 'VM', 'LastName': 'Motghare', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Chaitali S', 'Initials': 'CS', 'LastName': 'Bajait', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Mrunalini V', 'Initials': 'MV', 'LastName': 'Kalikar', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_441_18'] 2115,32565595,"Comparison of the efficacy of oral fenugreek seeds hydroalcoholic extract versus placebo in nonalcoholic fatty liver disease; a randomized, triple-blind controlled pilot clinical trial.","OBJECTIVES The aim of this study is to investigate the therapeutic property of hydroalcoholic extract of Fenugreek seeds in nonalcoholic fatty liver disease (NAFLD) in adult patients. METHODS This randomized, placebo-controlled, parallel trial was conducted from November 2014 to June 2017. Patients aged between 18 and 70 years old with confirmed NAFLD were recruited from the Motahhari clinic, affiliated to Shiraz University of Medical Sciences, Iran. Participants either received 1 g hydroalcoholic extract of Fenugreek seeds or placebo daily for 3 months. The primary outcomes were changes in serum alanine transaminase and FibroScan controlled attenuation parameter score. Secondary outcome measures were changes in other laboratory data, liver stiffness measure, liver steatosis percent, and anthropometric variables. Participants were randomly assigned to the groups using blocked randomization method. Participants, investigators, and statistician were blinded to treatments allocation. RESULTS After screening eighty patients, thirty patients met the inclusion criteria and were divided into two groups (1:1). After 3 months, two and four patients did not complete the trial in Fenugreek and placebo group, respectively. The changes in the anthropometrics, laboratories and FibroScan measurements were not statistically significant between the two groups. CONCLUSION The evidence to prove the efficacy of the Fenugreek seeds' hydroalcoholic extract in NAFLD was not strong enough; hence, further experiments are still needed to assess the possible efficacy of Fenugreek on the treatment of NAFLD.",2020,"The changes in the anthropometrics, laboratories and FibroScan measurements were not statistically significant between the two groups. ","['nonalcoholic fatty liver disease', 'adult patients', 'Patients aged between 18 and 70 years old with confirmed NAFLD were recruited from the Motahhari clinic, affiliated to Shiraz University of Medical Sciences, Iran', 'After screening eighty patients, thirty patients met the inclusion criteria', 'November 2014 to June 2017']","['hydroalcoholic extract of Fenugreek seeds or placebo', 'hydroalcoholic extract of Fenugreek seeds', 'oral fenugreek seeds hydroalcoholic extract versus placebo', 'placebo']","['anthropometrics, laboratories and FibroScan measurements', 'changes in other laboratory data, liver stiffness measure, liver steatosis percent, and anthropometric variables', 'serum alanine transaminase and FibroScan controlled attenuation parameter score']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453257', 'cui_str': 'Fenugreek seed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.348075,"The changes in the anthropometrics, laboratories and FibroScan measurements were not statistically significant between the two groups. ","[{'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Babaei', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Taghavi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Amin', 'Initials': 'MA', 'LastName': 'Mahdiyar', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Iranpour', 'Affiliation': 'Department of Radiology, Medical Imaging Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fardad', 'Initials': 'F', 'LastName': 'Ejtehadi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Abdolali', 'Initials': 'A', 'LastName': 'Mohagheghzadeh', 'Affiliation': 'Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Pharmaceutical Sciences Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_17_19'] 2116,32565613,A Participatory Integrated Health Promotion and Protection Worksite Intervention: A Cluster Randomized Controlled Trial.,"Our objective was to describe and evaluate an innovative approach to combining worksite wellness and ergonomics, with an emphasis on retention and absenteeism during the intervention. The study enrolled 280 employee participants in a 3-year cluster randomized, controlled trial conducted at The University of Iowa, 5 local businesses, and 1 regional business. Our results showed a 90% retention rate with lower estimated absenteeism (although not statistically significant) in the intervention group compared with the control group. This type of highly interactive and integrated short intervention has the capacity to result in high levels of participation with the potential to reduce absenteeism.",2016,Our results showed a 90% retention rate with lower estimated absenteeism (although not statistically significant) in the intervention group compared with the control group.,"['280 employee participants in a 3-year cluster randomized, controlled trial conducted at The University of Iowa, 5 local businesses, and 1 regional business']",[],['retention rate with lower estimated absenteeism'],"[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",[],"[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}]",280.0,0.0755169,Our results showed a 90% retention rate with lower estimated absenteeism (although not statistically significant) in the intervention group compared with the control group.,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Snetselaar', 'Affiliation': 'Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City (Dr Snetselaar, Mr Ahrens, and Ms Smith and Hollinger); and Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, Georgia (Dr Hockenberry). Department of Health Management & Policy and the Center for Outcomes Research, College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri (Dr Johnston).'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Ahrens', 'Affiliation': 'Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City (Dr Snetselaar, Mr Ahrens, and Ms Smith and Hollinger); and Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, Georgia (Dr Hockenberry). Department of Health Management & Policy and the Center for Outcomes Research, College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri (Dr Johnston).'}, {'ForeName': 'Kenton', 'Initials': 'K', 'LastName': 'Johnston', 'Affiliation': 'Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City (Dr Snetselaar, Mr Ahrens, and Ms Smith and Hollinger); and Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, Georgia (Dr Hockenberry). Department of Health Management & Policy and the Center for Outcomes Research, College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri (Dr Johnston).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City (Dr Snetselaar, Mr Ahrens, and Ms Smith and Hollinger); and Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, Georgia (Dr Hockenberry). Department of Health Management & Policy and the Center for Outcomes Research, College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri (Dr Johnston).'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hollinger', 'Affiliation': 'Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City (Dr Snetselaar, Mr Ahrens, and Ms Smith and Hollinger); and Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, Georgia (Dr Hockenberry). Department of Health Management & Policy and the Center for Outcomes Research, College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri (Dr Johnston).'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hockenberry', 'Affiliation': 'Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City (Dr Snetselaar, Mr Ahrens, and Ms Smith and Hollinger); and Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, Georgia (Dr Hockenberry). Department of Health Management & Policy and the Center for Outcomes Research, College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri (Dr Johnston).'}]",Topics in clinical nutrition,['10.1097/tin.0000000000000056'] 2117,32565647,Monthly maintenance protocol Bacillus Calmette-Guerin as a viable alternative to Southwest Oncology Group maintenance protocol in nonmuscle-invasive bladder cancer: A prospective randomized study.,"Introduction Bladder cancer is the most common malignancy of the urinary tract, and recurrence following transurethral resection poses the biggest challenge. Intravesical Bacillus Calmette-Guerin (BCG) maintenance with the Southwest Oncology Group (SWOG) protocol remains the gold standard but with poor patient compliance. Materials and Methods The present study aims to compare the SWOG maintenance protocol with a monthly maintenance protocol comprising 12 monthly doses of intravesical BCG. Patients are included in the study only if induction BCG is completed and cystoscopy at 3 months is negative. All patients receive 80 mg BCG in each dose with strict cystoscopic surveillance every 3 months. Results Patient demographics and tumor characteristics were similar in the two groups. There were no statistically significant differences in outcome in terms of recurrence, progression, and adverse reactions in both the groups. Although a larger number of patients in the SWOG maintenance group were lost to follow-up, the difference was not statistically significant proportions. Conclusion From this study, we can conclude that monthly maintenance BCG for 1 year is comparable in terms of outcome with SWOG protocol maintenance BCG. A greater percentage of patients in the monthly maintenance protocol completed the treatment as planned.",2020,"There were no statistically significant differences in outcome in terms of recurrence, progression, and adverse reactions in both the groups.",['nonmuscle-invasive bladder cancer'],"['Intravesical Bacillus Calmette-Guerin (BCG) maintenance', 'BCG', 'intravesical BCG']","['recurrence, progression, and adverse reactions']","[{'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C1289970', 'cui_str': 'Intravesical BCG'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.0455219,"There were no statistically significant differences in outcome in terms of recurrence, progression, and adverse reactions in both the groups.","[{'ForeName': 'Naveen Kumar', 'Initials': 'NK', 'LastName': 'Gupta', 'Affiliation': 'Department of Urology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Debansu', 'Initials': 'D', 'LastName': 'Sarkar', 'Affiliation': 'Department of Urology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Dilip Kumar', 'Initials': 'DK', 'LastName': 'Pal', 'Affiliation': 'Department of Urology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.'}]",Urology annals,['10.4103/UA.UA_29_19'] 2118,32565786,Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial.,"Background The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS. Method The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10 mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250 mg softgel capsules containing 180 mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability. Results The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively ( P < 0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm ( P < 0.001). Conclusions According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.",2020,"Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm ( P < 0.001). ","['Irritable Bowel Syndrome', 'patients with irritable bowel syndrome (IBS', 'parallel groups in Iran']","['ZM, AG, and TA essential oils', 'Novel Herbal Medicine', 'hyoscine butylbromide', 'softgel capsules containing 180\u2009mg of essential oils of ZM, AG, and TA']","['quality of life', 'Efficacy and Safety', 'improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability', 'efficacy and safety', 'response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI', 'IBS-AR, IBS-GAI, and IBS-SSS scales', 'IBS']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0006519', 'cui_str': 'Scopolamine butylbromide'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.16303,"Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm ( P < 0.001). ","[{'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Bordbar', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Miri', 'Affiliation': 'Department of Gastroenterology, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Omidi', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy and Pharmaceutical Sciences, Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shoja', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Akhavan', 'Affiliation': 'Pharmaceutical Sciences Research Center, Department of Medicinal Chemistry, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Gastroenterology research and practice,['10.1155/2020/8213082'] 2119,32563288,Placebo responses in Parkinson's disease.,"Parkinson's disease (PD) patients exhibit strong placebo responses in clinical trials. Patient characteristics that affect placebo include patients' expectations of good outcomes, genetic variants, and personality. The presence of motor fluctuation and high baseline UPDRS motor scores predicted placebo response. However, gender, age, duration of PD, religion, or level of education do not correlate with placebo response. PD patients who are preconditioned with active treatment such as apomorphine have more robust placebo effects. Studies that focused on patients with motor fluctuations, surgical intervention, or higher probability of placebo assignment had higher rates of placebo response. Patients view participating in placebo-controlled trials positively. Placebo effect can be measured objectively using neuroimaging and neurophysiological techniques. PET studies show that placebo-induced improvement is associated with dopamine release in the dorsal striatum and that the expectation of receiving the reward, not the reward itself, increased dopamine release in the ventral striatum. Expectations of benefitting from repetitive transcranial magnetic stimulation also induced dopamine release. Expectations of receiving a dopaminergic drug induced changes in fMRI in a reward-learning task. Single cell recordings demonstrate that placebo response is associated with changes of single neuronal activities in the basal ganglia circuit. These studies demonstrate that placebo effects are genuine biological responses to the administration of placebo. In clinical trials, we can use several approaches to minimize placebo responses. In clinical practice, we can use approaches to harness the power of placebo and minimize nocebo effects to improve patients' outcome.",2020,Expectations of benefitting from repetitive transcranial magnetic stimulation also induced dopamine release.,"[""Parkinson's disease"", 'PD patients who are preconditioned with active treatment such as', ""Parkinson's disease (PD) patients exhibit strong""]","['apomorphine', 'Placebo', 'placebo']","['rates of placebo response', 'single neuronal activities']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.292027,Expectations of benefitting from repetitive transcranial magnetic stimulation also induced dopamine release.,"[{'ForeName': 'Jau-Shin', 'Initials': 'JS', 'LastName': 'Lou', 'Affiliation': 'Roger Gilbertson Endowed Chair in Neurology, Department of Neurology, University of North Dakota School of Medicine & Health Science, and Sanford Health, Fargo, ND, United States. Electronic address: jaushin.lou@und.edu.'}]",International review of neurobiology,['10.1016/bs.irn.2020.03.031'] 2120,31836178,"Perioperative tight glycemic control using artificial pancreas decreases infectious complications via suppression of inflammatory cytokines in patients who underwent pancreaticoduodenectomy: A prospective, non-randomized clinical trial.","BACKGROUND We sought to investigate the efficacy of perioperative tight glycemic control (TGC) in reducing of postoperative infectious complications (POICs) and study its impact on early inflammatory mediators in patients who underwent pancreaticoduodenectomy. METHODS In this non-randomized trial, the artificial pancreas (AP) group received TGC (target glucose range of 80-110 mg/dL; n = 14), while the control group received conventional glycemic control (range of 80-180 mg/dL; n = 15). The primary endpoint was POICs. RESULTS The AP group had a markedly decreased POIC rate (28.6% vs. 73.3%; P = 0.027), mean glycemic variability (13.5 ± 3.5% vs. 16.4 ± 5.9%; P = 0.038), and plasma interleukin-6 level (26.3 ± 33.8 vs 98.3 ± 89.1 pg/ml; P = 0.036) compared to the control group, but insulin dosage (27.0 ± 13.4 vs. 10.2 ± 16.2 U; P = 0.002) and the adiponectin ratio (i.e., postoperative/preoperative adiponectin; 0.8 ± 0.2 vs. 0.6 ± 0.3; P = 0.021) were markedly higher in the AP group. CONCLUSIONS Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs. SUMMARY Perioperative hyperglycemia increases postoperative infectious complications; however, tight glycemic control using artificial pancreas can reduce them via a dual effect. Artificial pancreas facilitates strict and safe glycemic control while reducing anti-inflammatory mediators, including adiponectin, following pancreaticoduodenectomy.",2020,"Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs. ","['patients who underwent', 'patients who underwent pancreaticoduodenectomy', 'patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control']","['pancreaticoduodenectomy', 'artificial pancreas', 'artificial pancreas (AP) group received TGC', 'perioperative tight glycemic control (TGC', 'conventional glycemic control']","['mean glycemic variability', 'adiponectin ratio', 'POIC rate', 'plasma interleukin-6 level', 'POICs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0612314,"Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs. ","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Akabori', 'Affiliation': 'Department of Surgery, Shiga, Japan. Electronic address: hakabori@belle.shiga-med.ac.jp.'}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kitamura', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Maehira', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Imashuku', 'Affiliation': 'Department of Anesthesiology, Shiga, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tsujita', 'Affiliation': 'Department of Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Anesthesiology, Shiga, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.12.008'] 2121,31885339,Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin within 24 hours postoperatively for treatment of bladder cancer.,"OBJECTIVE To investigate the efficacy and safety of transurethral holmium laser resection (THOLR) and transurethral electrocision (TUR) combined with intravesical epirubicin within 24 hours postoperatively for treatment of non-muscular invasive bladder cancer. METHODS A total of 218 consecutive patients who were newly diagnosed with bladder cancer were enrolled in this prospective study from July 2014 to December 2017. The patients were randomly divided into THOLR and TUR groups. All patients received intravesical epirubicin (30 mg dissolved in 5% glucose solution) within 24 hours postoperatively. The operation time, blood loss, rate of obturator reflex, hospitalization time, catheterization time, complications, and recurrence were analyzed. RESULTS Operation, hospitalization, and catheterization times were significantly greater in the TUR group than in the THOLR group. The rates of blood loss and intraoperative obturator reflex were also significantly greater in the TUR group. There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. CONCLUSIONS THOLR and TUR combined with intravesical epirubicin within 24 hours postoperatively were both safe and effective for treatment of bladder tumor; however, patients who undergo THOLR might experience more rapid recovery.",2020,"There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. ","['218 consecutive patients who were newly diagnosed with bladder cancer were enrolled in this prospective study from July 2014 to December 2017', 'non-muscular invasive bladder cancer', 'bladder cancer']","['transurethral holmium laser resection (THOLR) and transurethral electrocision (TUR) combined with intravesical epirubicin', 'TUR', 'THOLR and TUR combined with intravesical epirubicin', 'Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin', 'intravesical epirubicin']","['Operation, hospitalization, and catheterization times', 'efficacy and safety', 'operation time, blood loss, rate of obturator reflex, hospitalization time, catheterization time, complications, and recurrence', 'complications, recurrence rate survival, or recurrence-free survival', 'rates of blood loss and intraoperative obturator reflex']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182021', 'cui_str': 'Obturator'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",218.0,0.0160123,"There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. ","[{'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Yagang', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Huidong', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}]",The Journal of international medical research,['10.1177/0300060519887267'] 2122,32571960,Lung ultrasound-guided therapy reduces acute decompensation events in chronic heart failure.,"OBJECTIVE Pulmonary congestion is the main cause of hospital admission in patients with heart failure (HF). Lung ultrasound (LUS) is a useful tool to identify subclinical pulmonary congestion. We evaluated the usefulness of LUS in addition to physical examination (PE) in the management of outpatients with HF. METHODS In this randomised multicentre unblinded study, patients with chronic HF and optimised medical therapy were randomised in two groups: 'PE+LUS' group undergoing PE and LUS and 'PE only' group. Diuretic therapy was modified according to LUS findings and PE, respectively. The primary endpoint was the reduction in hospitalisation rate for acute decompensated heart failure (ADHF) at 90-day follow-up. Secondary endpoints were reduction in NT-proBNP, quality-of-life test (QLT) and cardiac mortality at 90-day follow-up. RESULTS A total of 244 patients with chronic HF and optimised medical therapy were enrolled and randomised in 'PE+LUS' group undergoing PE and LUS, and in 'PE only' group. Thirty-seven primary outcome events occurred. The hospitalisation for ADHF at 90 day was significantly reduced in 'PE+LUS' group (9.4% vs 21.4% in 'PE only' group; relative risk=0.44; 95% CI 0.23 to 0.84; p=0.01), with a reduction of risk for hospitalisation for ADHF by 56% (p=0.01) and a number needed to treat of 8.4 patients (95% CI 4.8 to 34.3). At day 90, NT-proBNP and QLT score were significantly reduced in 'PE+LUS' group, whereas in 'PE only' group both were increased. There were no differences in mortality between the two groups. CONCLUSIONS LUS-guided management reduces hospitalisation for ADHF at mid-term follow-up in outpatients with chronic HF.",2020,"At day 90, NT-proBNP and QLT score were significantly reduced in 'PE+LUS' group, whereas in 'PE only' group both were increased.","['outpatients with chronic HF', '244 patients with chronic HF and optimised medical therapy', 'outpatients with HF', 'patients with chronic HF and optimised medical therapy', 'chronic heart failure', 'patients with heart failure (HF']","[""PE+LUS' group undergoing PE and LUS and 'PE only' group"", 'Lung ultrasound (LUS', 'Diuretic therapy', ""PE+LUS' group undergoing PE and LUS, and in 'PE only' group"", 'LUS', 'Lung ultrasound-guided therapy', 'LUS-guided management']","['hospitalisation for ADHF', 'NT-proBNP and QLT score', 'mortality', 'risk for hospitalisation for ADHF', 'acute decompensation events', 'reduction in NT-proBNP, quality-of-life test (QLT) and cardiac mortality at 90-day follow-up', 'reduction in hospitalisation rate for acute decompensated heart failure (ADHF']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",244.0,0.0917393,"At day 90, NT-proBNP and QLT score were significantly reduced in 'PE+LUS' group, whereas in 'PE only' group both were increased.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Marini', 'Affiliation': 'Cardiovascular Imaging Unit, San Raffaele Scientific Institute, Milan, Italy claudia.marini@outlook.com.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Fragasso', 'Affiliation': 'Heart Failure Clinic, Clinical Cardiology, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Italia', 'Affiliation': 'Cardiovascular Imaging Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Hamayak', 'Initials': 'H', 'LastName': 'Sisakian', 'Affiliation': 'Department of Cardiology, Yerevan State Medical University, University Hospital 1, Yerevan, Armenia.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Tufaro', 'Affiliation': 'Cardiovascular Imaging Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Ingallina', 'Affiliation': 'Cardiovascular Imaging Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Stella', 'Affiliation': 'Cardiovascular Imaging Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ancona', 'Affiliation': 'Cardiovascular Imaging Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Loiacono', 'Affiliation': 'Heart Failure Clinic, Clinical Cardiology, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Innelli', 'Affiliation': 'SSD Imaging Cardiovascular Department, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Marco Fabio', 'Initials': 'MF', 'LastName': 'Costantino', 'Affiliation': 'SSD Imaging Cardiovascular Department, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sahakyan', 'Affiliation': 'Department of Cardiology, Yerevan State Medical University, University Hospital 1, Yerevan, Armenia.'}, {'ForeName': 'Sirvard', 'Initials': 'S', 'LastName': 'Gabrielyan', 'Affiliation': 'Department of Cardiology, Yerevan State Medical University, University Hospital 1, Yerevan, Armenia.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Avetisyan', 'Affiliation': 'Department of Cardiology, Yerevan State Medical University, University Hospital 1, Yerevan, Armenia.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Margonato', 'Affiliation': 'Heart Failure Clinic, Clinical Cardiology, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Eustachio', 'Initials': 'E', 'LastName': 'Agricola', 'Affiliation': 'Cardiovascular Imaging Unit, San Raffaele Scientific Institute, Milan, Italy.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-316429'] 2123,32572017,General Anesthesia Maintained with Sevoflurane versus Propofol in Pediatric Surgery Shorter Than 1 Hour: A Randomized Single-Blind Study.,"BACKGROUND Sevoflurane was compared with propofol for general anesthesia maintenance in pediatric operations lasting less than 1 hour in terms of anesthetic effect and postoperative recovery. MATERIAL AND METHODS Children scheduled for inguinal hernia repair or hydrocele testis repair were randomly assigned to receive general anesthesia maintained with either sevoflurane (n=43) or propofol (n=43). The ilioinguinal nerve was blocked with 1% lidocaine (7 mg/kg) after intravenous administration of ketamine (2 mg/kg). At the end of the surgery in patients receiving sevoflurane, sevoflurane was stopped and a bolus of propofol of 1 mg/kg was administered. RESULTS Sevoflurane was associated with significantly less use of ketamine (35.1±10.6 mg) than was propofol (59.0±28.0 mg; P<0.001). In addition, sevoflurane was associated with a significantly shorter time in the post-anesthesia care unit (52.1±9.0 min) than was propofol (68.8±15.3 min; P<0.001). Propofol was associated with a significantly higher incidence of intraoperative body movement (33.3%) than was sevoflurane (13.5%; P=0.045). However, the 2 groups showed no important differences in other adverse events such as hypoxia, emergence agitation, and additional use of propofol. CONCLUSIONS In pediatric surgery lasting less than 1 hour, anesthesia maintained with sevoflurane was associated with significantly less use of ketamine, shorter postoperative recovery time, and less intraoperative body movement than was propofol.",2020,Propofol was associated with a significantly higher incidence of intraoperative body movement (33.3%) than was sevoflurane (13.5%; P=0.045).,"['Pediatric Surgery Shorter Than 1 Hour', 'Children scheduled for inguinal hernia repair or hydrocele testis repair']","['general anesthesia maintained with either sevoflurane', 'sevoflurane, sevoflurane', 'ketamine', 'lidocaine', 'Sevoflurane versus Propofol', 'Propofol', 'sevoflurane', 'propofol', 'Sevoflurane']","['intraoperative body movement', 'adverse events such as hypoxia, emergence agitation, and additional use of propofol']","[{'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C1720771', 'cui_str': 'Hydrocele'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",,0.0664735,Propofol was associated with a significantly higher incidence of intraoperative body movement (33.3%) than was sevoflurane (13.5%; P=0.045).,"[{'ForeName': 'Guisheng', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923681'] 2124,32521133,Thrombectomy for Stroke in the Public Health Care System of Brazil.,"BACKGROUND Randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion. These trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries. METHODS We studied the safety and efficacy of thrombectomy in the public health system of Brazil. In 12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. RESULTS A total of 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; P = 0.001), favoring thrombectomy. The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6). Asymptomatic intracranial hemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group; symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group. CONCLUSIONS In this randomized trial conducted in the public health care system of Brazil, endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone. (Funded by the Brazilian Ministry of Health; RESILIENT ClinicalTrials.gov number, NCT02216643.).",2020,"The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69;","['12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms', '300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period', 'public health system of Brazil', '221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group', 'patients with stroke']","['standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group', 'intravenous alteplase']","['modified Rankin scale', 'modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit', 'score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death', 'Asymptomatic intracranial hemorrhage', 'symptomatic intracranial hemorrhage']","[{'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",300.0,0.164028,"The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69;","[{'ForeName': 'Sheila O', 'Initials': 'SO', 'LastName': 'Martins', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': ""Mont'Alverne"", 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Letícia C', 'Initials': 'LC', 'LastName': 'Rebello', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Abud', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Gisele S', 'Initials': 'GS', 'LastName': 'Silva', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Fabrício O', 'Initials': 'FO', 'LastName': 'Lima', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Bruno S M', 'Initials': 'BSM', 'LastName': 'Parente', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Guilherme S', 'Initials': 'GS', 'LastName': 'Nakiri', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Mário B', 'Initials': 'MB', 'LastName': 'Faria', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Michel E', 'Initials': 'ME', 'LastName': 'Frudit', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'João J F', 'Initials': 'JJF', 'LastName': 'de Carvalho', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Waihrich', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Fiorot', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Fabrício B', 'Initials': 'FB', 'LastName': 'Cardoso', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Raquel C T', 'Initials': 'RCT', 'LastName': 'Hidalgo', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Viviane F', 'Initials': 'VF', 'LastName': 'Zétola', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Fernanda M', 'Initials': 'FM', 'LastName': 'Carvalho', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'de Souza', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Dias', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Bandeira', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Maramélia', 'Initials': 'M', 'LastName': 'Miranda Alves', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Mário B', 'Initials': 'MB', 'LastName': 'Wagner', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Leonardo A', 'Initials': 'LA', 'LastName': 'Carbonera', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Jamary', 'Initials': 'J', 'LastName': 'Oliveira-Filho', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bezerra', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Broderick', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'José E', 'Initials': 'JE', 'LastName': 'Fogolin Passos', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Octávio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2000120'] 2125,32521250,"Efficacy and safety of TS-121, a novel vasopressin V 1B receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study.","Vasopressin 1B (V 1B ) receptor has a pivotal role in the regulation of the hypothalamus-adrenal-pituitary axis, and V 1B receptor antagonists have shown efficacy in a number of preclinical models of depression. The efficacy and safety of, TS-121 (active ingredient: THY1773), a novel V 1B receptor antagonist, was investigated in patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy. In a randomized, double-blind, placebo-controlled phase 2 study, 51 MDD patients (43 of whom completed the study) were randomly assigned to either TS-121 10 mg, 50 mg or placebo for 6 weeks treatment period. The primary endpoint was change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6. The study was conducted from Jul 2017 to Dec 2018. The changes from baseline in MADRS score at week 6 (Least Square Mean [95% Confidence interval] were: TS-121 10 mg (-9.0 [-13.9, -4.1]), TS-121 50 mg (-9.0 [-13.4, -4.5]), and placebo (-6.4 [-10.7, -2.2]). TS-121 groups showed greater numerical reductions in MADRS score change from baseline compared to placebo, though these reductions did not achieve statistical significance. Similar trends of numerically greater improvements in TS-121 groups were observed across secondary endpoints. Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint. These findings, combined with favorable safety and tolerability, warrant further investigation of TS-121 in an adequately powered study in patients with MDD.",2020,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"['51 MDD patients (43 of whom completed the study', 'patients with MDD', 'patients with major depressive disorder', 'patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy', 'Jul 2017 to Dec 2018']","['TS-121, a novel vasopressin V 1B receptor antagonist', 'Vasopressin 1B (V 1B ) receptor', 'TS-121', 'TS-121 50\xa0mg', 'TS-121 10\xa0mg, 50\xa0mg or placebo', 'placebo']","['MADRS score', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'MADRS score change', 'Higher baseline urinary and hair cortisol levels']","[{'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",51.0,0.556683,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kamiya', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA. Electronic address: ma-kamiya@taisho.co.jp.'}, {'ForeName': 'Helene D', 'Initials': 'HD', 'LastName': 'Sabia', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marella', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit Street, Bulfinch 351, Boston, MA, 02114, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': 'University of Texas Dell Medical School in Austin, 1601 Trinity Street, Stop Z0600, Office HDB 4.112, Austin, TX, 78712, USA.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Umeuchi', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Michihiko', 'Initials': 'M', 'LastName': 'Iijima', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Chaki', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nishino', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.017'] 2126,32567234,"The impact of negative-pressure wound therapy with instillation on wounds requiring operative debridement: Pilot randomised, controlled trial.","Presence of bacteria in wounds can delay healing. Addition of a regularly instilled topical solution over the wound during negative-pressure wound therapy (NPWT) may reduce bioburden levels compared with standard NPWT alone. We performed a prospective, randomised, multi-centre, post-market trial to compare effects of NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy in wounds requiring operative debridement. Results showed a significantly greater mean decrease in total bacterial counts from time of initial surgical debridement to first dressing change in NPWT plus instillation (n = 69) subjects compared with standard NPWT (n = 63) subjects (-0.18 vs 0.6 log 10 CFU/g, respectively). There was no significant difference between the groups in the primary endpoint of required inpatient operating room debridements after initial debridement. Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications were similar. NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects. This study provides a basis for exploring research options to understand the impact of NPWT with instillation on wound healing.",2020,NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects.,['wounds requiring operative debridement'],"['negative-pressure wound therapy with instillation', 'NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy', 'standard NPWT', 'negative-pressure wound therapy (NPWT']","['total bacterial counts', 'bioburden levels', 'Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications', 'risk of re-hospitalisation']","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",69.0,0.0491176,NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects.,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Lavery', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Galiano', 'Affiliation': 'Northwestern Memorial Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Salgado', 'Affiliation': 'University of Miami Health System, Miami, Florida, USA.'}, {'ForeName': 'Dennis P', 'Initials': 'DP', 'LastName': 'Orgill', 'Affiliation': ""Division of Plastic Surgery, Brigham & Women's Hospital Wound Care Center, Boston, Massachusetts, USA.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kovach', 'Affiliation': 'Penn Plastic Surgery University City, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Brent H', 'Initials': 'BH', 'LastName': 'Bernstein', 'Affiliation': ""St. Luke's University Health Network, Bethlehem, Pennsylvania, USA.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Attinger', 'Affiliation': 'Department of Plastic Surgery, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",International wound journal,['10.1111/iwj.13424'] 2127,32567237,Eye patching after cataract surgery is associated with an increased risk of short-term corneal oedema.,"PURPOSE To evaluate the effect of postoperative eye patching after routine cataract surgery on corneal oedema and visual acuity on the first postoperative day. SETTING One public healthcare centre. DESIGN AND METHODS This randomized controlled trial included patients undergoing uneventful cataract surgery in one medical centre. Patients were randomized into two groups: the surgical eye was patched with a single dose of a local steroid and antibiotic for 24 hr in the first group, and a plastic shield was used in the second with local steroid and antibiotic drops. The eyes were examined preoperatively and on the first postoperative day. Examination included the following: best-corrected visual acuity (BCVA), full slit lamp examination, intraocular pressure (IOP), anterior chamber depth (ACD) and central corneal thickness (CCT) using the IOL Master 700 (Zeiss, Germany). Cumulative dissipated energy (CDE) and operation time were recorded for all cases. RESULTS One hundred eyes of 100 patients were included in the study. The postoperative increase in CCT 24 hr after surgery was 138 and 70 µm in the patched group as compared to the non-patched group, respectively (p = 0.001). Best-corrected visual acuity (BCVA) on the first postoperative day was 0.5 ± 0.45 LogMAR and 0.3 ± 0.3 LogMAR in the patched and non-patched group, respectively (p = 0.01). There was no difference in CDE (11.33 ± 9.2 and 10.22 ± 7.3; p = 0.94) between the two groups. CONCLUSIONS Eye patching after routine cataract surgery is associated with an increase in corneal oedema and slower visual recovery on the first postoperative day.",2020,"The postoperative increase in CCT 24 hr after surgery was 138 and 70 µm in the patched group as compared to the non-patched group, respectively (p = 0.001).","['One hundred eyes of 100 patients were included in the study', 'One public healthcare centre', 'patients undergoing uneventful cataract surgery in one medical centre']","['local steroid and antibiotic', 'postoperative eye patching after routine cataract surgery', 'local steroid and antibiotic drops']","['best-corrected visual acuity (BCVA), full slit lamp examination, intraocular pressure (IOP), anterior chamber depth (ACD) and central corneal thickness (CCT) using the IOL Master 700 (Zeiss, Germany', 'Best-corrected visual acuity (BCVA', 'Cumulative dissipated energy (CDE) and operation time', 'corneal oedema and visual acuity', 'corneal oedema and slower visual recovery', 'postoperative increase in CCT 24\xa0hr after surgery', 'CDE', 'risk of short-term corneal oedema']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",100.0,0.0716937,"The postoperative increase in CCT 24 hr after surgery was 138 and 70 µm in the patched group as compared to the non-patched group, respectively (p = 0.001).","[{'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Gazit', 'Affiliation': ""Department of Ophthalmology, Shamir Medical Center, Beer Ya'acov, Israel.""}, {'ForeName': 'Biana', 'Initials': 'B', 'LastName': 'Dubinsky-Pertzov', 'Affiliation': ""Department of Ophthalmology, Shamir Medical Center, Beer Ya'acov, Israel.""}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Or', 'Affiliation': ""Department of Ophthalmology, Shamir Medical Center, Beer Ya'acov, Israel.""}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Pras', 'Affiliation': ""Department of Ophthalmology, Shamir Medical Center, Beer Ya'acov, Israel.""}, {'ForeName': 'Avner', 'Initials': 'A', 'LastName': 'Belkin', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Einan-Lifshitz', 'Affiliation': ""Department of Ophthalmology, Shamir Medical Center, Beer Ya'acov, Israel.""}]",Acta ophthalmologica,['10.1111/aos.14510'] 2128,32567238,Rationale and design of the AUGUST-AHF Study.,"AIMS We aim to assess the effect of a lyophilized herbal injection on 90 day mortality and readmission rates in patients with acute heart failure (AHF). METHODS AND RESULTS The AUGUST-AHF study is a multicentre, randomized, double-blind, placebo-controlled trial enrolling 1270 hospitalized patients for AHF. Patients are randomized to receive YiqiFumai lyophilized injection (5.2 g/day) or placebo for 10 days, in addition to standard therapy, using a 1:1 ratio via an interactive web response system. The primary endpoint is the 90 day all-cause mortality or AHF readmission rates. Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events. Additional secondary endpoints include change in dyspnoea via visual analogue scale (VAS) and Likert 7-point comparator scale, N terminal pro-B-type natriuretic peptide value and New York Heart Association functional class, and the total amount of diuretics for the indexed AHF hospitalization. Study recruitment is expected to be completed by March 2021, and follow-up will end in September 2021. In an optional sub-study, patients will be followed up for 3 years. CONCLUSIONS To our best knowledge, AUGUST-AHF is the first study assessing the efficacy of a Chinese herbal injection in patients with AHF. The results will be valuable to guide clinicians in using YiqiFumai lyophilized injection, which was included in the latest Chinese Health Insurance Catalog.",2020,"Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events.","['patients with acute heart failure (AHF', 'patients with AHF', '1270 hospitalized patients for AHF']","['lyophilized herbal injection', 'YiqiFumai lyophilized injection', 'Chinese herbal injection', 'placebo']","['change in dyspnoea via visual analogue scale (VAS) and Likert 7-point comparator scale, N terminal pro-B-type natriuretic peptide value and New York Heart Association functional class, and the total amount of diuretics for the indexed AHF hospitalization', '180\xa0day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90\xa0day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90\xa0day major adverse cardiac events', '90\xa0day all-cause mortality or AHF readmission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C3711493', 'cui_str': 'yi-qi-fu-mai'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0918012', 'cui_str': 'Indexes as Topic'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1270.0,0.263515,"Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events.","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Catholic Health System Internal Medicine Training Program, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hongcai', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}]",ESC heart failure,['10.1002/ehf2.12787'] 2129,32567245,Contrast-enhanced CT radiomics for preoperative evaluation of microvascular invasion in hepatocellular carcinoma: A two-center study.,"BACKGROUND The present study constructed and validated the use of contrast-enhanced computed tomography (CT)-based radiomics to preoperatively predict microvascular invasion (MVI) status (positive vs negative) and risk (low vs high) in patients with hepatocellular carcinoma (HCC). METHODS We enrolled 637 patients from two independent institutions. Patients from Institution I were randomly divided into a training cohort of 451 patients and a test cohort of 111 patients. Patients from Institution II served as an independent validation set. The LASSO algorithm was used for the selection of 798 radiomics features. Two classifiers for predicting MVI status and MVI risk were developed using multivariable logistic regression. We also performed a survival analysis to investigate the potentially prognostic value of the proposed MVI classifiers. RESULTS The developed radiomics signature predicted MVI status with an area under the receiver operating characteristic curve (AUC) of .780, .776, and .743 in the training, test, and independent validation cohorts, respectively. The final MVI status classifier that integrated two clinical factors (age and α-fetoprotein level) achieved AUC of .806, .803, and .796 in the training, test, and independent validation cohorts, respectively. For MVI risk stratification, the AUCs of the radiomics signature were .746, .664, and .700 in the training, test, and independent validation cohorts, respectively, and the AUCs of the final MVI risk classifier-integrated clinical stage were .783, .778, and .740, respectively. Survival analysis showed that our MVI status classifier significantly stratified patients for short overall survival or early tumor recurrence. CONCLUSIONS Our CT radiomics-based models were able to predict MVI status and MVI risk of HCC and might serve as a reliable preoperative evaluation tool.",2020,"For MVI risk stratification, the AUCs of the radiomics signature were .746, .664, and .700 in the training, test, and independent validation cohorts, respectively, and the AUCs of the final MVI risk classifier-integrated clinical stage were .783, .778, and .740, respectively.","['451 patients and a test cohort of 111 patients', '637 patients from two independent institutions', 'Patients from Institution', 'patients with hepatocellular carcinoma (HCC', 'hepatocellular carcinoma']","['Contrast-enhanced CT radiomics', 'contrast-enhanced computed tomography (CT)-based radiomics']","['overall survival or early tumor recurrence', 'MVI status and MVI risk']","[{'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",637.0,0.0281016,"For MVI risk stratification, the AUCs of the radiomics signature were .746, .664, and .700 in the training, test, and independent validation cohorts, respectively, and the AUCs of the final MVI risk classifier-integrated clinical stage were .783, .778, and .740, respectively.","[{'ForeName': 'Xiuming', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shijian', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'College of Information Science and Electronic Engineering, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'College of Information Science and Electronic Engineering, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'College of Information Science and Electronic Engineering, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Weihai', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, The People's Hospital of Beilun District, Ningbo, China.""}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Dalong', 'Initials': 'D', 'LastName': 'Wan', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yunjun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Hanjin', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'College of Information Science and Electronic Engineering, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Tingbo', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",Clinical and translational medicine,['10.1002/ctm2.111'] 2130,32567439,"Acute and Chronic Effects of SGLT2 Inhibitor Empagliflozin on Renal Oxygenation and Blood Pressure Control in Nondiabetic Normotensive Subjects: A Randomized, Placebo-Controlled Trial.","Background The sodium/glucose cotransporter 2 inhibitor empagliflozin has cardiorenal protective properties through mechanisms beyond glucose control. In this study we assessed whether empagliflozin modifies renal oxygenation as a possible mechanism of renal protection, and determined the metabolic, renal, and hemodynamic effects of empagliflozin in nondiabetic subjects. Methods and Results In this double-blind, randomized, placebo-controlled study, 45 healthy volunteers underwent blood and urine sampling, renal ultrasound, and blood-oxygenation-level-dependent magnetic resonance imaging before and 180 minutes after administration of 10 mg empagliflozin (n=30) or placebo (n=15). These examinations were repeated after 1 month of daily intake. Cortical and medullary renal oxygenation were not affected by the acute or chronic administration of empagliflozin, as determined by 148 renal blood-oxygenation-level-dependent magnetic resonance imaging examinations. Empagliflozin increased glucosuria (24-hour glucosuria at 1 month: +50.1±16.3 g). The acute decrease in proximal sodium reabsorption, as determined by endogenous fractional excretion of lithium (-34.6% versus placebo), was compensated at 1 month by a rise in plasma renin activity (+28.6%) and aldosterone (+55.7%). The 24-hour systolic and diastolic ambulatory blood pressures decreased significantly after 1 month of empagliflozin administration (-5.1 and -2.0 mm Hg, respectively). Serum uric acid levels decreased (-28.4%), hemoglobin increased (+1.7%), and erythropoietin remained the same. Conclusions Empagliflozin has a rapid and significant effect on tubular function, with sustained glucosuria and transient natriuresis in nondiabetic normotensive subjects. These effects favor blood pressure reduction. No acute or sustained changes were found in renal cortical or medullary tissue oxygenation. It remains to be determined whether this is the case in nondiabetic or diabetic patients with congestive heart failure or kidney disease. REGISTRATION : URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT03093103.",2020,"Serum uric acid levels decreased (-28.4%), hemoglobin increased (+1.7%), and erythropoietin remained the same.","['45 healthy volunteers underwent blood and urine sampling, renal ultrasound, and blood-oxygenation-level-dependent magnetic resonance imaging before and 180\xa0minutes after administration of 10 mg', 'nondiabetic or diabetic patients with congestive heart failure or kidney disease', 'Nondiabetic Normotensive Subjects', 'nondiabetic normotensive subjects', 'nondiabetic subjects']","['Placebo', 'empagliflozin', 'SGLT2 Inhibitor Empagliflozin', 'sodium/glucose cotransporter 2 inhibitor empagliflozin', 'Empagliflozin', 'placebo']","['endogenous fractional excretion of lithium', 'plasma renin activity', 'proximal sodium reabsorption', 'renal cortical or medullary tissue oxygenation', 'Cortical and medullary renal oxygenation', 'glucosuria (24-hour glucosuria', 'Serum uric acid levels', '24-hour systolic and diastolic ambulatory blood pressures', 'Renal Oxygenation and Blood Pressure Control', 'hemoglobin', 'blood pressure reduction']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0203408', 'cui_str': 'Echography of kidney'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0001629', 'cui_str': 'Adrenal medulla structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",45.0,0.280845,"Serum uric acid levels decreased (-28.4%), hemoglobin increased (+1.7%), and erythropoietin remained the same.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zanchi', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burnier', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Muller', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Arlène', 'Initials': 'A', 'LastName': 'Ghajarzadeh-Wurzner', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Maillard', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Loncle', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Milani', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Dufour', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonny', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'Pruijm', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.016173'] 2131,32567443,Application of intraoperative electrophysiological monitoring in vertebral canal decompression surgery for acute spinal cord injury.,"OBJECTIVE This study aimed to evaluate the joint monitoring of somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) in vertebral canal decompression surgery for acute spinal cord injury. METHODS Twenty-four patients, who were admitted to the hospital for the surgical treatment of spinal cord injury with SEP and MEP monitoring, were assigned to the intraoperative monitoring group (group I). In addition, 24 patients who were admitted to the hospital for the surgical treatment of spinal cord injury without SEP or MEP monitoring were assigned to the control group (group C). RESULTS In group I, there were significant changes before and after decompression surgery in the P40 latency and amplitude, and in the latency of MEP in the abductor hallucis brevis (AHB), in patients with improved spinal nerve function following surgery. In contrast, there were no significant differences in the P40 latency or amplitude, or the latency of MEP in the AHB, in patients who showed no improvement after surgery. CONCLUSION In vertebral canal decompression surgery for acute spinal cord injury, the application of joint MEP and SEP monitoring can timely reflect changes in spinal cord function.",2020,"In group I, there were significant changes before and after decompression surgery in the P40 latency and amplitude, and in the latency of MEP in the abductor hallucis brevis (AHB), in patients with improved spinal nerve function following surgery.","['vertebral canal decompression surgery for acute spinal cord injury', 'Twenty-four patients, who were admitted to the hospital for the surgical treatment of spinal cord injury with SEP and MEP monitoring', '24 patients who were admitted to the hospital for the surgical treatment of spinal cord injury without SEP or MEP monitoring']","['intraoperative monitoring group', 'intraoperative electrophysiological monitoring', 'somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs', 'vertebral canal decompression surgery']","['latency of MEP in the abductor hallucis brevis (AHB', 'P40 latency or amplitude, or the latency of MEP', 'spinal nerve function']","[{'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0079637', 'cui_str': 'Intraoperative Monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}, {'cui': 'C0079407', 'cui_str': 'Gene Product, tax'}, {'cui': 'C0037941', 'cui_str': 'Spinal nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",24.0,0.0372423,"In group I, there were significant changes before and after decompression surgery in the P40 latency and amplitude, and in the latency of MEP in the abductor hallucis brevis (AHB), in patients with improved spinal nerve function following surgery.","[{'ForeName': 'Qun-Xi', 'Initials': 'QX', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Xiang-Nan', 'Initials': 'XN', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Ai-Jun', 'Initials': 'AJ', 'LastName': 'Fu', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Yun-He', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Tie-Jun', 'Initials': 'TJ', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Fu-Xia', 'Initials': 'FX', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}]",The Journal of international medical research,['10.1177/0300060520924205'] 2132,32567472,"Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients.","Background and purpose - Physically and mentally fit patients with a displaced femoral neck fracture (FNF) are mostly treated with total hip arthroplasty (THA). Dislocation is a severe and frequent complication in this group, and dual mobility cups (DMC) were developed to reduce the risk of dislocation after THA. The DUALITY trial investigates whether the use of DMC in FNF patients treated with a THA reduces the risk of dislocation.Patients and methods - The trial is a national, multicenter, register-based, randomized controlled trial (rRCT). Patients ≥ 65 years with a non-pathological, displaced FNF (Type Garden 3-4/AO 31-B2 or B3) who are suitable for a THA according to local guidelines are assessed for eligibility using the web-based registration platform of the Swedish Fracture Register (SFR). 1,600 patients will be randomized 1:1 to either insertion of a DMC (intervention group) or a standard cup (control group). The study is pragmatic in that the choice of implant brands, surgical approach, and peri- and postoperative protocols follow the local routines of each participating unit. All outcome variables will be retrieved after linkage of the study cohort obtained from the SFR with the Swedish Hip Arthroplasty Register and the National Patient Register.Outcomes - The primary outcome is the occurrence of any dislocation of the index joint treated with closed or open reduction within 1 year after surgery, expressed as a relative risk when comparing groups, and a risk reduction of at least 45% is considered clinically relevant. Secondary outcomes are the relative risk of any reoperation of the index joint, periprosthetic joint infection, and mortality within 90 days and 1 year. Patient-reported outcomes and health economics are evaluated.Start of trial and estimated duration - The DUALITY trial started recruiting patients in January 2020 and will continue for approximately 5 years.Trial registration - The trial is registered at clinicaltrials.gov (NCT03909815; December 12, 2019).",2020,"The primary outcome is the occurrence of any dislocation of the index joint treated with closed or open reduction within 1 year after surgery, expressed as a relative risk when comparing groups, and a risk reduction of at least 45% is considered clinically relevant.","['hip fracture patients', 'Patients ≥ 65 years with a non-pathological, displaced FNF (Type Garden 3-4/AO 31-B2 or B3) who are suitable for a THA according to local guidelines are assessed for eligibility using the web-based registration platform of the Swedish Fracture Register (SFR', 'mentally fit patients with a displaced femoral neck fracture (FNF', '1,600 patients', 'FNF patients treated with a']","['THA', 'DMC', 'DMC (intervention group) or a standard cup (control group', 'dual mobility cups', 'total hip arthroplasty (THA']","['occurrence of any dislocation of the index joint treated with closed or open reduction within 1 year after surgery, expressed as a relative risk', 'relative risk of any reoperation of the index joint, periprosthetic joint infection, and mortality within 90 days and 1 year', 'risk of dislocation']","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0265286', 'cui_str': 'Dyggve-Melchior-Clausen syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1600.0,0.170258,"The primary outcome is the occurrence of any dislocation of the index joint treated with closed or open reduction within 1 year after surgery, expressed as a relative risk when comparing groups, and a risk reduction of at least 45% is considered clinically relevant.","[{'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Wolf', 'Affiliation': 'Department of Surgical Sciences, Orthopaedics, Uppsala University.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mukka', 'Affiliation': 'Department of Surgical and Perioperative Science (Orthopaedics), Umeå University.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Notini', 'Affiliation': 'Department of Surgical Sciences, Orthopaedics, Uppsala University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Möller', 'Affiliation': 'Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Nils P', 'Initials': 'NP', 'LastName': 'Hailer', 'Affiliation': 'Department of Surgical Sciences, Orthopaedics, Uppsala University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acta orthopaedica,['10.1080/17453674.2020.1780059'] 2133,32567478,The Feasibility and Efficacy of an Israeli Lifestyle Redesign®-Based Program for Well Older Adults: A Pilot Study.,"The Israeli Lifestyle Program (ILP) was adapted from the original Lifestyle Redesign® intervention, aiming to enhance health, functioning, and quality of life (QoL) of older adults. The purpose of this study was to examine the feasibility and effectiveness of the ILP. The design of the study entailed a non-randomized trial with a 3-month follow-up including 18 women aged 65 to 81 recruited from a community center. The research group ( n = 9) participated in 15 weekly group meetings and three individual sessions. The control group ( n = 9) received an information booklet based on the ILP content. Between-group comparisons revealed significant differences in change scores in favor of the research group for occupational performance ( U = 19.0, p = .03), environmental ( U = 21.5, p = .04), and social ( U = 20.5, p = .03) QoL factors. Findings also revealed reduction in depressive symptoms ( U = 24.0, p = .07). These findings suggest community group programs for improving occupational performance and QoL.",2020,"Between-group comparisons revealed significant differences in change scores in favor of the research group for occupational performance ( U = 19.0, p = .03), environmental ( U = 21.5, p = .04), and social ( U = 20.5, p = .03) QoL factors.","['Well Older Adults', '18 women aged 65 to 81 recruited from a community center', 'older adults']","['Israeli Lifestyle Program (ILP', 'ILP', 'information booklet based on the ILP content', 'Israeli Lifestyle Redesign®-Based Program']","['occupational performance and QoL', 'change scores', 'occupational performance', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",18.0,0.0314457,"Between-group comparisons revealed significant differences in change scores in favor of the research group for occupational performance ( U = 19.0, p = .03), environmental ( U = 21.5, p = .04), and social ( U = 20.5, p = .03) QoL factors.","[{'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Maeir', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Beit-Yosef', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Wechsler', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Safra', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Zilbershlag', 'Affiliation': 'Ono Academic College, Israel.'}, {'ForeName': 'Noomi', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'Ono Academic College, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Gilboa', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University of Jerusalem, Israel.'}]","OTJR : occupation, participation and health",['10.1177/1539449220928141'] 2134,32567869,Longitudinal effects of psychotherapy with transgender and nonbinary clients: A randomized controlled pilot trial.,"Minority stress has been determined to contribute to some mental health concerns for transgender, nonbinary, and gender nonconforming individuals, yet little is known regarding interventions to decrease the effects of minority stress. The purpose of this pilot study was to assess the feasibility and relative effectiveness of two interventions developed for work with transgender clients. Transgender individuals ( N = 20) were recruited to participate in a randomized controlled trial comparing two psychotherapy interventions for transgender adults seeking psychotherapy for a variety of concerns: (a) transgender affirmative psychotherapy (TA) and (b) Building Awareness of Minority Stressors + Transgender Affirmative psychotherapy. Gender-related stress and resilience were assessed before, immediately after, and 6 months following the intervention; psychological distress and working alliance were assessed at these three time points as well as weekly during the intervention. Feasibility and acceptability of the study and psychotherapy interventions were supported. Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences. Results from this study support further evaluation of both treatment arms in a larger randomized controlled trial. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences.,"['Transgender individuals ( N = 20', 'and nonbinary clients']","['psychotherapy interventions for transgender adults seeking psychotherapy for a variety of concerns: (a) transgender affirmative psychotherapy (TA) and (b) Building Awareness of Minority Stressors + Transgender Affirmative psychotherapy', 'psychotherapy with transgender']","['psychological distress and working alliance', 'internalized stigma and nonaffirmation experiences', 'feasibility and relative effectiveness', 'Feasibility and acceptability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0655726,Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences.,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Budge', 'Affiliation': 'Department of Counseling Psychology.'}, {'ForeName': 'Morgan T', 'Initials': 'MT', 'LastName': 'Sinnard', 'Affiliation': 'Department of Counseling Psychology.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Hoyt', 'Affiliation': 'Department of Counseling Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000310'] 2135,32567941,The effect of an oral spray containing an aqueous extract of Triticum vulgare on dental plaque and gingival inflammation in schoolchildren: A randomized controlled trial.,"AIM To investigate whether the daily use of a spray containing an aqueous extract of Triticum vulgare (TV), belonging to the family of Graminaceae, associated with supervised toothbrushing may improve gingival health in schoolchildren with mixed dentition. MATERIALS AND METHODS Study design: Randomised, controlled, single-centre, examiner blind, parallel-group study. The study population included 57 schoolchildren with plaque-induced gingivitis randomly allocated to test (n = 29) and control (n = 28) group. Both groups were enrolled in a mechanical plaque control programme for a period of 2 weeks. The test group was also instructed to use a gluten free spray formulation of TV spray twice daily after toothbrushing. Evaluations of plaque index, modified gingivitis index (GI), salivary pH and whole stimulated saliva quantity took place at baseline and after 1 and 2 weeks of study product use. RESULTS No side effects were observed. Plaque accumulation and GI statistically significantly improved compared with baseline in both groups (all P-values < 0.005), while salivary pH remained nearly unchanged. Between-group differences in index reduction were statistically significant only for GI favouring the test group (P = 0.013). STATISTICS Repeated-measures ANOVA and the Friedman test were applied to evaluate the influence of time on quantitative variables within each treatment group. Differences between test and control groups were tested using the unpaired t test or the Mann-Whitney U-test with Bonferroni correction. CONCLUSIONS This study found that TV in spray formulation is safe and effective in controlling gingival inflammation. Thus, it may be a potential adjuvant in the treatment of gingivitis in combination with mechanical plaque control in schoolchildren.",2020,"Plaque accumulation and GI statistically significantly improved compared with baseline in both groups (all P-values < 0.005), while salivary pH remained nearly unchanged.","['schoolchildren', '57 schoolchildren with plaque-induced gingivitis randomly allocated to test (n = 29) and control (n = 28) group', 'schoolchildren with mixed dentition', 'Study design']","['oral spray containing an aqueous extract of Triticum vulgare', 'spray containing an aqueous extract of Triticum vulgare (TV', 'mechanical plaque control programme']","['dental plaque and gingival inflammation', 'Plaque accumulation and GI', 'plaque index, modified gingivitis index (GI), salivary pH and whole stimulated saliva quantity took place', 'gingival health', 'salivary pH', 'index reduction', 'side effects']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011444', 'cui_str': 'Mixed dentition'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C1154184', 'cui_str': 'Oral spray'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1123020', 'cui_str': 'Triticum aestivum'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",57.0,0.0438323,"Plaque accumulation and GI statistically significantly improved compared with baseline in both groups (all P-values < 0.005), while salivary pH remained nearly unchanged.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bello', 'Affiliation': 'Department of Surgical Sciences, C.I.R. Dental School, Section of Paediatric Dentistry, University of Turin, Turin, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Romano', 'Affiliation': 'Department of Surgical Sciences, C.I.R. Dental School, Section of Periodontology, University of Turin, Turin, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gaido', 'Affiliation': 'Department of Surgical Sciences, C.I.R. Dental School, Section of Paediatric Dentistry, University of Turin, Turin, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Defabianis', 'Affiliation': 'Department of Surgical Sciences, C.I.R. Dental School, Section of Paediatric Dentistry, University of Turin, Turin, Italy.'}]",European journal of paediatric dentistry,['10.23804/ejpd.2020.21.02.04'] 2136,32567948,Effects of audiovisual distraction in children with Down syndrome during dental restorations: a randomised clinical trial.,"AIM To evaluate the effect of audiovisual distraction on the dental chairside behaviour of children with Down syndrome (DS) during dental restorations and its influence on the operator stress and the duration of the appointment. MATERIALS AND METHODS Study design: This randomised controlled trial included 48 children with DS requiring dental restorations. The study group was treated while wearing video eyeglasses, the control group with conventional behaviour management techniques. The child behaviour was evaluated using the revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC) and the Frankl scale. The operator stress was evaluated using a VAS scale and the duration of the appointment was recorded. RESULTS In the study group 64% of the children refused to wear the video eyeglasses during the whole duration of the dental treatment, the median r-FLACC score was significantly higher (p= 0.01552; Mann Whitney U test) and significantly more children showed a negative behaviour (68%vs 30%: p =0.011; Chi-square test). CONCLUSION Audiovisual distraction using video eyeglasses is not useful in managing the dental chairside behaviour of children with DS.",2020,"CONCLUSION Audiovisual distraction using video eyeglasses is not useful in managing the dental chairside behaviour of children with DS.","['children with Down syndrome during dental restorations', 'children with Down syndrome (DS', 'children with DS', '48 children with DS requiring dental restorations', 'Study design']","['control group with conventional behaviour management techniques', 'Audiovisual distraction', 'audiovisual distraction']","['video eyeglasses', 'negative behaviour', 'revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC) and the Frankl scale', 'VAS scale', 'median r-FLACC score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0399059', 'cui_str': 'Restoration of tooth'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150143', 'cui_str': 'Behavior management'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",48.0,0.044028,"CONCLUSION Audiovisual distraction using video eyeglasses is not useful in managing the dental chairside behaviour of children with DS.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bagattoni', 'Affiliation': 'Department of Biomedical and NeuroMotor Sciences (DiBiNeM), Unit of Dental Care for Special Needs Patients and Paediatric Dentistry, University of Bologna, Bologna, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lardani', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, Dental and Oral Surgery Clinic, Unit of Pediatric Dentistry, University of Pisa, Pisa, Italy.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Gatto', 'Affiliation': 'Department of Biomedical and NeuroMotor Sciences (DiBiNeM), Unit of Dental Care for Special Needs Patients and Paediatric Dentistry, University of Bologna, Bologna, Italy.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Giuca', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, Dental and Oral Surgery Clinic, Unit of Pediatric Dentistry, University of Pisa, Pisa, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Piana', 'Affiliation': 'Department of Biomedical and NeuroMotor Sciences (DiBiNeM), Unit of Dental Care for Special Needs Patients and Paediatric Dentistry, University of Bologna, Bologna, Italy.'}]",European journal of paediatric dentistry,['10.23804/ejpd.2020.21.02.11'] 2137,32567975,Effects of aerobic and cognitively-engaging physical activity on academic skills: A cluster randomized controlled trial.,"This cluster randomized controlled trial (trial-number #) compares effects of two school-based physical activity interventions (aerobic vs. cognitively-engaging) on reading, mathematics, and spelling achievement; and whether effects are influenced by volume of moderate-to-vigorous physical activity and baseline achievement. Twenty-two primary schools participated, where a third and fourth grade class were randomly assigned to the intervention or control group. Intervention groups were randomly assigned to a 14-week aerobic or cognitively-engaging intervention, receiving four physical education lessons a week. Control groups followed their regular physical education program. Academic achievement of 891 children (mean age 9.17 years, 49.4% boys) was assessed with standardized tests before and after the interventions. Post-Test academic achievement did not significantly differ between intervention groups and control group. A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group. Compared to the control group, lower achievers in reading performed better in reading after the cognitively-engaging intervention. A combination of moderate-to-vigorous physical activity and cognitively-engaging exercises seems to have the most beneficial effects. Future intervention studies should take into account quantitative and qualitative aspects of physical activity, and children's baseline academic achievement.",2020,"A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group.","['891 children (mean age 9.17\xa0years, 49.4% boys', 'academic skills', 'Twenty-two primary schools participated, where a third and fourth grade class']","['regular physical education program', '14-week aerobic or cognitively-engaging intervention, receiving four physical education lessons a week', 'aerobic and cognitively-engaging physical activity', 'two school-based physical activity interventions (aerobic vs. cognitively-engaging']","['Post-Test academic achievement', 'reading, mathematics, and spelling achievement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",891.0,0.0342309,"A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group.","[{'ForeName': 'Anne G M', 'Initials': 'AGM', 'LastName': 'De Bruijn', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Danny D N M', 'Initials': 'DDNM', 'LastName': 'Kostons', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Irene M J', 'Initials': 'IMJ', 'LastName': 'Van Der Fels', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Visscher', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam , Amsterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hartman', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Bosker', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}]",Journal of sports sciences,['10.1080/02640414.2020.1756680'] 2138,32572439,Biomarkers of orthodontic tooth movement with fixed appliances and vibration appliance therapy: a pilot study.,"INTRODUCTION The aim of this study was to investigate the effect of supplemental vibratory force on biomarkers of bone remodelling during orthodontic tooth movement, the rate of mandibular anterior alignment (RMAA), and compliance with a vibration device. DESIGN, SETTINGS, AND PARTICIPANTS Forty patients between the ages 15-35 undergoing fixed appliance treatment that presented to a university orthodontic clinic were randomly allocated to supplemental use of an intraoral vibrational device (n = 20, AcceleDent®) or fixed appliance only (n = 20). Salivary multiplex assay was completed to analyse the concentration of selected biomarkers of bone remodelling before treatment (T0) and at three following time points (T1, T2, T3), 4-6 weeks apart. Irregularity of the mandibular anterior teeth and compliance was assessed at the same trial time points. Data were analysed blindly on an intention-to-treat basis with descriptive statistics, Mann-Whitney U-test, Wilcoxon signed-rank test, and linear mixed effects regression modelling. RESULTS No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed. No correlation was found between changes in irregularity and biomarker level from baseline to another time point. Lastly, there was no association between RMAA and compliance with the AcceleDent® device. CONCLUSIONS Supplemental vibratory force during orthodontic treatment with fixed appliances does not affect biomarkers of bone remodelling or the RMAA. LIMITATIONS The main limitation of the study was the small sample size and the large variability in the salivary biomarkers. HARMS No harms were observed during the duration of the trial. PROTOCOL The protocol was not published prior to trial commencement. REGISTRATION The study was registered in Clinical Trials.gov (NCT02119455) first posted on April 2014.",2020,No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed.,['Forty patients between the ages 15-35 undergoing fixed appliance treatment that presented to a university orthodontic clinic'],"['fixed appliances and vibration appliance therapy', 'intraoral vibrational device (n = 20, AcceleDent®) or fixed appliance', 'supplemental vibratory force']","['salivary biomarkers of bone remodelling and RMAA', 'rate of mandibular anterior alignment (RMAA), and compliance with a vibration device', 'irregularity and biomarker level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.100189,No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed.,"[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Reiss', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Marie Claude', 'Initials': 'MC', 'LastName': 'Chouinard', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Dasha', 'Initials': 'D', 'LastName': 'Frias Landa', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Taranpreet', 'Initials': 'T', 'LastName': 'Chandhoke', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Sobue', 'Affiliation': 'Division of Periodontics, Department of Oral Health and Diagnostic Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Veerasathpurush', 'Initials': 'V', 'LastName': 'Allareddy', 'Affiliation': 'Department of Orthodontics, College of Dentistry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chia-Ling', 'Initials': 'CL', 'LastName': 'Kuo', 'Affiliation': 'CICATS/Department of Community Medicine/Institute for System Genomics, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Jinjian', 'Initials': 'J', 'LastName': 'Mu', 'Affiliation': 'CICATS/Department of Community Medicine/Institute for System Genomics, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Uribe', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}]",European journal of orthodontics,['10.1093/ejo/cjaa026'] 2139,32572446,Exposure and Absorption of PAHs in Wildland Firefighters: A Field Study with Pilot Interventions.,"OBJECTIVES There is limited knowledge of exposure to polycyclic aromatic hydrocarbons (PAHs) in wildland firefighters, or of the effectiveness of interventions to reduce this. This study of wildland firefighters assessed whether PAHs were present and considered respiratory protection and enhanced skin hygiene as possible interventions. METHODS 1-Hydroxypyrene (1-HP) was measured in urine samples collected pre-shift, post-shift, and next morning from wildland firefighters in Alberta and British Columbia. Skin wipes, collected pre- and post-shift, were analysed for eight PAHs. Breathing zone air samples were analysed for 11 PAHs. As pilot interventions, participants were randomized to either normal or enhanced skin hygiene. A sample of volunteers was assigned to a disposable N95 mask or a half facepiece mask with P100 organic vapour cartridge. Participants completed a brief questionnaire on activities post-shift and respiratory symptoms. RESULTS Non-smoking firefighters (66 male and 20 female) were recruited from 11 fire crews. Air sampling pumps were carried for the full shift by 28 firefighters, 25 firefighters wore masks (14 N95 and 11 P100); 42 were assigned to the enhanced skin hygiene intervention. Sixty had hot spotting as their main task. Air monitoring identified PAHs (benzo(b,j,k)fluoranthene in particulates, phenanthrene in the gaseous phase) for 6 of the 11 crews. PAHs (largely naphthalene) were found post-shift on 40/84 skin wipes from the hand and 38/84 from jaw/throat. The mean increase in 1-HP in urine samples collected after the shift (compared with samples collected before the shift) was 66 ng g-1 creatinine (P < 0.001) with an increase over the shift found for 76% of participants. 1-HP in next morning urine samples was significantly lower than at the end of shift (a reduction of 39.3 ng g-1: P < 0.001). The amount of naphthalene on skin wipes was greater at the end of the shift (post) than at the start (pre). The mean post-pre weight difference of naphthalene on skin wipes taken from the hand was 0.96 ng wipe-1 (P = 0.01) and from the jaw/throat 1.28 ng wipe-1 (P = 0.002). The enhanced skin hygiene intervention lead to a larger reduction in 1-HP between end of shift and next morning urine samples but only for those with naphthalene on skin wipes at the end of shift. The difference in 1-HP concentration in urine samples collected before and after the shift was reduced for those wearing a mask (linear tend P = 0.063, one-sided). In multivariable models, 1-HP at end of shift was related to gaseous phase phenanthrene, estimated from air sampling [β = 318.2, 95% confidence interval (CI) 67.1-569.2]. Naphthalene on hand skin wipes reflected work in hot spotting during the shift (β = 0.53, 95% CI 0.22-0.86). CONCLUSIONS This study provided evidence of PAHs in the air and on the skin of many, but not all, fire crew. Absorbed PAHs, reflected in 1-HP in urine, increased over the shift. Results from the pilot interventions suggest that enhanced skin hygiene would reduce absorption post fire where PAHs had been accumulated on the skin, and that masks could be effective in reducing PAH inhalation exposure. Interventions to reduce PAH absorption are supported by the pilot work reported here and warrant further evaluation across a full fire season.",2020,"The difference in 1-HP concentration in urine samples collected before and after the shift was reduced for those wearing a mask (linear tend P = 0.063, one-sided).","['Non-smoking firefighters (66 male and 20 female) were recruited from 11 fire crews', 'Wildland Firefighters']","['normal or enhanced skin hygiene', 'disposable N95 mask or a half facepiece mask with P100 organic vapour cartridge', 'enhanced skin hygiene intervention']","['skin wipes', 'urine samples', 'Breathing zone air samples', 'mean post-pre weight difference of naphthalene on skin wipes taken', '1-HP concentration']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1286234', 'cui_str': 'Skin hygiene'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1546536', 'cui_str': 'Air sample'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0027375', 'cui_str': 'Naphthalene'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0044415', 'cui_str': '1-hydroxypyrene'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0342456,"The difference in 1-HP concentration in urine samples collected before and after the shift was reduced for those wearing a mask (linear tend P = 0.063, one-sided).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cherry', 'Affiliation': 'Division of Preventive Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Galarneau', 'Affiliation': 'Division of Preventive Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kinniburgh', 'Affiliation': 'Alberta Centre for Toxicology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Quemerais', 'Affiliation': 'Division of Preventive Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Tiu', 'Affiliation': 'Alberta Centre for Toxicology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alberta Centre for Toxicology, University of Calgary, Calgary, Alberta, Canada.'}]",Annals of work exposures and health,['10.1093/annweh/wxaa064'] 2140,32572490,Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis.,"OBJECTIVES Electronic patient-reported outcomes (ePROs) transmitted digitally allow patients to communicate with their clinicians and track the activity of chronic diseases, such as RA. Several ePRO smartphone apps have been developed in rheumatology, yet few data have been reported regarding patient adherence. We developed a PRO app for RA and assessed adherence over 6 months. METHODS We developed an app to deliver daily assessments to participants (RA App v.1.0). The app was tested as part of a randomized controlled trial examining potential clinical benefits. The current analyses focus on the adherence to the ePRO app for patients randomized to receive the app. We recruited RA patients from an academic rheumatology practice in the USA. Patients randomized to receive the app received daily notifications regarding ePROs. We examined adherence to the PRO questionnaires over the 6-month study and examined factors related to adherence. RESULTS Seventy-eight patients received the app and have data included in these analyses: 63 (80.7%) were female, mean age was 55.2 years, 71% had attended college or beyond, and the mean Clinical Disease Activity Index at baseline was 9.7 (low disease activity). Median adherence to the daily questions was 79% (interquartile range 48-90%). Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). CONCLUSION We developed and tested an ePRO app for RA over a 6-month study. Adherence to the app was strong. There was correlation between older age and better disease control and increased adherence. TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02822521.",2020,"Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). ","['RA patients from an academic rheumatology practice in the USA', 'Seventy-eight patients received the app and have data included in these analyses: 63 (80.7%) were female, mean age was 55.2\u2009years, 71% had attended college or beyond, and the mean Clinical Disease Activity Index at baseline was 9.7 (low disease activity']",['daily notifications regarding ePROs'],"['low baseline Clinical Disease Activity Index', 'Median adherence', 'PRO questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.175824,"Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). ","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Yvonne C', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Northwestern University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Marquez-Grap', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Division of Rheumatology, Brigham and Women's Hospital, Boston, MA.""}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa202'] 2141,32572510,Evaluation of the Sensitivity of the Nipple-Areola Complex in Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release: A Randomized Controlled Trial.,"BACKGROUND In the surgical treatment of breast ptosis, the plastic surgeon's main challenge is to mobilize the nipple-areola complex (NAC) over long distances, preserving its sensitivity. Herein, we aimed to evaluate the NAC sensitivity following a periareolar dermis release in patients undergoing surgical correction of breast ptosis. METHODS This is a prospective, double-blinded, randomized study in which 39 patients (78 breasts) were operated on for the treatment of breast ptosis. Patients' breasts were divided into two groups, each breast in a group. In breasts of the experiment group, the periareolar dermis release was used after decortication. This maneuver was not used in the control group's breasts. To analyze the sensitivity in relation with the distance that the NAC should be mobilized to correct breast ptosis, the value of 6 cm was used as boundary. Sensitivity of the NAC was assessed with monofilaments preoperatively and postoperatively-at three and six weeks and one year. RESULTS Regarding the sensitivity of the areola, a significant difference was observed in the comparison between the control and experiment groups at the NAC mobility ≤ 6.0 cm in the preoperative. Regarding the nipple, a significant difference was observed in the comparison between the control and experiment groups at three weeks postoperatively for a NAC mobility ≤ 6.0 cm. After one year, there was no difference in the comparison between the groups in either areola or nipple. CONCLUSION The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction. LEVEL OF EVIDENCE II This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,"The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction. ","['39 patients (78 breasts', ""Patients' breasts"", 'Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release', 'patients undergoing surgical correction of breast ptosis', 'patients undergoing breast ptosis correction']",[],"['Sensitivity of the NAC', 'NAC sensitivity', 'periareolar dermis release']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",,0.0314583,"The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction. ","[{'ForeName': 'Jairo Zacchê', 'Initials': 'JZ', 'LastName': 'Sá', 'Affiliation': 'Plastic Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santa Cruz Oliveira', 'Affiliation': 'School of Medicine, Federal University of Pernambuco, Av. Prof. Moraes Rego, 1235 - Cidade Universitária, Recife, PE, 50670-901, Brazil. f.santacruzoliveira@gmail.com.'}, {'ForeName': 'William Flávio', 'Initials': 'WF', 'LastName': 'Santinoni', 'Affiliation': 'Plastic Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Freire', 'Affiliation': 'School of Medicine, Federal University of Pernambuco, Av. Prof. Moraes Rego, 1235 - Cidade Universitária, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Amanda Estelita', 'Initials': 'AE', 'LastName': 'de Oliveira Rodrigues', 'Affiliation': 'Department of Physiotherapy, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'José Lamartine', 'Initials': 'JL', 'LastName': 'de Andrade Aguiar', 'Affiliation': 'Experimental Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01835-7'] 2142,32572802,Impact of Coenzyme Q10 and Selenium on Seminal Fluid Parameters and Antioxidant Status in Men with Idiopathic Infertility.,"Oxidative stress (OS) is a key contributing factor in 30-80% of male infertility cases. To date, several antioxidant treatments have been put forth to manage OS-induced male infertility. This study intended to elucidate the impact of coenzyme Q10 (CoQ10) and selenium on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia (OAT). In this prospective study, 70 patients with idiopathic OAT were randomly allocated to receive CoQ10 (200 mg/day) or selenium (200 μg/day) for 3 months. Semen quality parameters (following WHO guidelines, 5th edition), total antioxidant capacity (TAC), catalase (CAT), and superoxide dismutase (SOD) activities were compared before and after the treatment. The results of the study showed an increase in sperm concentration with CoQ10 treatment (p < 0.01) as well as increased progressive sperm motility (p < 0.01 and p < 0.05) and total sperm motility (p < 0.01 and p < 0.05) with CoQ10 and selenium treatment respectively. There was also a significant improvement in TAC (p < 0.01 and p < 0.05) and SOD (p < 0.01 and p < 0.05) following treatment with CoQ10 and selenium respectively while CAT improved only with CoQ10 therapy (p < 0.05). Sperm concentration, motility, and morphology also correlated significantly with TAC, SOD, and CAT (r = 0.37-0.76). In conclusion, treatment with CoQ10 (200 mg) or selenium (200 μg) could improve sperm concentration, motility, and antioxidant status in infertile men with idiopathic OAT with CoQ10 providing the higher improvement.",2020,The results of the study showed an increase in sperm concentration with CoQ10 treatment (p < 0.01) as well as increased progressive sperm motility (p < 0.01 and p < 0.05) and total sperm motility (p < 0.01 and p < 0.05) with CoQ10 and selenium treatment respectively.,"['Men with Idiopathic Infertility', 'infertile men with idiopathic OAT with', '30-80% of male infertility cases', 'infertile men with idiopathic oligoasthenoteratospermia (OAT', '70 patients with idiopathic OAT']","['CoQ10', 'Coenzyme Q10 and Selenium', 'CoQ10 (200\xa0mg) or selenium', 'selenium', 'coenzyme Q10 (CoQ10) and selenium']","['total sperm motility', 'progressive sperm motility', 'Semen quality parameters', 'Sperm concentration, motility, and morphology', 'Seminal Fluid Parameters and Antioxidant Status', 'sperm concentration', 'Oxidative stress (OS', 'TAC', 'sperm concentration, motility, and antioxidant status', 'TAC, SOD, and CAT', 'SOD', 'total antioxidant capacity (TAC), catalase (CAT), and superoxide dismutase (SOD) activities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0036614', 'cui_str': 'Seminal fluid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",70.0,0.0627992,The results of the study showed an increase in sperm concentration with CoQ10 treatment (p < 0.01) as well as increased progressive sperm motility (p < 0.01 and p < 0.05) and total sperm motility (p < 0.01 and p < 0.05) with CoQ10 and selenium treatment respectively.,"[{'ForeName': 'Ahmed T', 'Initials': 'AT', 'LastName': 'Alahmar', 'Affiliation': 'College of Medicine, University of Babylon, Babyl, Iraq. ahmed.t.alahmar@gmail.com.'}, {'ForeName': 'Pallav', 'Initials': 'P', 'LastName': 'Sengupta', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, MAHSA University, Jenjarom, Malaysia.'}]",Biological trace element research,['10.1007/s12011-020-02251-3'] 2143,32572849,Systemic Pharmacokinetics of Oxaliplatin After Intraperitoneal Administration by Electrostatic Pressurized Intraperitoneal Aerosol Chemotherapy (ePIPAC) in Patients with Unresectable Colorectal Peritoneal Metastases in the CRC-PIPAC Trial.,"BACKGROUND Electrostatic pressurized intraperitoneal aerosol chemotherapy (ePIPAC) is a palliative treatment for unresectable peritoneal metastases from various primary cancers. However, little is known about the systemic pharmacokinetics of oxaliplatin after ePIPAC. METHODS Twenty patients with unresectable colorectal peritoneal metastases were treated with repetitive ePIPAC monotherapy with oxaliplatin (92 mg/m 2 ) and a simultaneous intravenous bolus of leucovorin (20 mg/m 2 ) and 5-fluorouracil (400 mg/m 2 ). Samples were collected during each ePIPAC: whole blood at t = 0, t = 5, t = 10, t = 20, t = 30, t = 60, t = 120, t = 240, t = 360 and t = 1080 min for plasma and plasma ultrafiltrate concentrations; urine at t = 0, t = 1, t = 3, t = 5 and t = 7 days. Samples were analyzed using atomic absorption spectrometry. Pharmacokinetics were analyzed using nonlinear mixed-effects modeling. RESULTS Four patients received one ePIPAC, three patients received two ePIPAC, and thirteen patients received ≥ 3 ePIPAC. The population pharmacokinetic models adequately described the pharmacokinetics of oxaliplatin after ePIPAC. The plasma ultrafiltrate C max of oxaliplatin reached 1.36-1.90 µg/mL after 30 min with an AUC 0-24 h of 9.6-11.7 µg/mL * h. The plasma C max reached 2.67-3.28 µg/mL after 90 min with an AUC 0-24 h of 49.0-59.5 µg/mL * h. The absorption rate constant (Ka) was 1.13/h. Urine concentrations of oxaliplatin rapidly decreased to less than 3.60 µg/mL in 90% of the samples at day 7. DISCUSSION Systemic exposure to oxaliplatin after ePIPAC seemed comparable to that after systemic chemotherapy, as described in other literature. Since this is an indirect comparison, future research should focus on the direct comparison between the systemic exposure to oxaliplatin after ePIPAC and after systemic chemotherapy. TRIAL REGISTRATION NCT03246321, Pre-results; ISRCTN89947480, Pre-results; NTR6603, Pre-results; EudraCT: 2017-000927-29, Pre-results.",2020,"Urine concentrations of oxaliplatin rapidly decreased to less than 3.60 µg/mL in 90% of the samples at day 7. ","['Twenty patients with unresectable colorectal peritoneal metastases', 'Patients with Unresectable Colorectal Peritoneal Metastases in the CRC-PIPAC Trial']","['oxaliplatin', 'leucovorin', 'Electrostatic Pressurized Intraperitoneal Aerosol Chemotherapy (ePIPAC', 'repetitive ePIPAC monotherapy with oxaliplatin', 'Oxaliplatin', 'Electrostatic pressurized intraperitoneal aerosol chemotherapy (ePIPAC', '5-fluorouracil']","['plasma C max', 'Urine concentrations of oxaliplatin rapidly', 'plasma ultrafiltrate C max of oxaliplatin', 'absorption rate constant (Ka']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0376534', 'cui_str': 'Electrostatics'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",20.0,0.0320051,"Urine concentrations of oxaliplatin rapidly decreased to less than 3.60 µg/mL in 90% of the samples at day 7. ","[{'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Lurvink', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'Rudaba', 'Initials': 'R', 'LastName': 'Tajzai', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'Koen P', 'Initials': 'KP', 'LastName': 'Rovers', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'Emma C E', 'Initials': 'ECE', 'LastName': 'Wassenaar', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands.'}, {'ForeName': 'Dirk-Jan A R', 'Initials': 'DAR', 'LastName': 'Moes', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pluimakers', 'Affiliation': 'Department of Clinical Pharmacy, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'Djamila', 'Initials': 'D', 'LastName': 'Boerma', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands.'}, {'ForeName': 'Jacobus W A', 'Initials': 'JWA', 'LastName': 'Burger', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Nienhuijs', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'Ignace H J T', 'Initials': 'IHJT', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'Maarten J', 'Initials': 'MJ', 'LastName': 'Deenen', 'Affiliation': 'Department of Clinical Pharmacy, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. maarten.deenen@catharinaziekenhuis.nl.'}]",Annals of surgical oncology,['10.1245/s10434-020-08743-9'] 2144,32572862,Anterior versus posterior peroral endoscopic myotomy: 2-years post-procedure follow-up from a randomized controlled trial.,"BACKGROUND AND AIMS Peroal endoscopic myotomy (POEM) is considered a primary treatment modality for achalasia. It can be performed using either the anterior or posterior approach. A previous randomized clinical trial showed that the posterior approach was non-inferior to the anterior approach at 1-year post-POEM in terms of clinical success, rate of adverse event and risk of gastroesophageal reflux disease (GERD). The aim of this post-RCT study is to compare the outcomes at ≥ 2-years post-POEM. METHODS Patients who previously completed their 1-year follow-up were contacted and their Eckardt (ES), Dysphagia, and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores and frequency of proton pump inhibitor (PPI) use were recorded. Clinical success was defined as ES<3. RESULTS A total of 150 patients were initially randomized and 138 completed their 1-year follow-up. Out of the 138, 111 (anterior group 54, posterior group 57) completed their ≥ 2-years follow-up with an overall clinical success decrease from 89% to 82%. At ≥ 2-years post-POEM, clinical success was achieved in 46/54 (85%) and 45/57 (79%) in the anterior and posterior groups, respectively (p=0.43). A similar decrease in clinical success was noted in both groups at ≥ 2-years (anterior: 90% to 85%; posterior 89% to 79%; p=0.5). GERDQ score was 6 (IQR: 6-8) (p = 0.08) in both treatment groups. CONCLUSIONS The anterior and posterior POEM techniques remained equally effective at 2 years and a similar decrease in efficacy was noted over time. GERD outcomes were also similar between both groups during medium-term follow-up.",2020,A similar decrease in clinical success was noted in both groups at ≥ 2-years,"['Patients who previously completed their 1-year follow-up were contacted and their', 'A total of 150 patients were initially randomized and 138 completed their 1-year follow-up']","['Peroal endoscopic myotomy (POEM', 'Anterior versus posterior peroral endoscopic myotomy']","['Clinical success', 'clinical success', 'clinical success, rate of adverse event and risk of gastroesophageal reflux disease (GERD', 'efficacy', 'GERDQ score', 'GERD outcomes', 'Eckardt (ES), Dysphagia, and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores and frequency of proton pump inhibitor (PPI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C4760898', 'cui_str': 'Peroral endoscopic myotomy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",150.0,0.119721,A similar decrease in clinical success was noted in both groups at ≥ 2-years,"[{'ForeName': 'Yervant', 'Initials': 'Y', 'LastName': 'Ichkhanian', 'Affiliation': 'Johns Hopkins Medical Institutions, Division of Gastroenterology and Hepatology, Baltimore, United States.'}, {'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'AbiMansour', 'Affiliation': 'Johns Hopkins Hospital, Medicine, Baltimore, United States.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pioche', 'Affiliation': 'Edouard Herriot Hospital, Endoscopy and Gastroenterology Unit, Lyon, France.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Vosoughi', 'Affiliation': 'Johns Hopkins Medical Institutions, Division of Gastroenterology and Hepatology, Baltimore, United States.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Eleftheriadis', 'Affiliation': 'Endoscopy Department, Metropolitan Hospital, Athens, Gastroenterology Department, Piraeus, Greece.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chiu', 'Affiliation': 'Chinese University of Hong Kong, Department of Surgery, Hong Kong, Hong Kong.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': 'Nagasaki University Hospital, Department of Gastroenterology and Hepatology, Nagasaki, Japan.'}, {'ForeName': 'Kumi', 'Initials': 'K', 'LastName': 'Ogihara', 'Affiliation': 'Nagasaki University Hospital, Department of Gastroenterology and Hepatology, 1-7-1 Sakamoto, Nagasaki-Shi, Japan.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sanaei', 'Affiliation': 'Johns Hopkins Medical Institutions, Division of Gastroenterology and Hepatology, Baltimore, United States.'}, {'ForeName': 'Manol', 'Initials': 'M', 'LastName': 'Jovani', 'Affiliation': 'Johns Hopkins Medical Institutions, Division of Gastroenterology and Hepatology, Baltimore, United States.'}, {'ForeName': 'Mouen', 'Initials': 'M', 'LastName': 'Khashab', 'Affiliation': 'Johns Hopkins Hospital, Director of Therapeutic Endoscopy, Baltimore, United States.'}]",Endoscopy,['10.1055/a-1204-4242'] 2145,32572955,"Expression of NF-κB, IL-6, and IL-10 genes, body composition, and hepatic fibrosis in obese patients with NAFLD-Combined effects of oleoylethanolamide supplementation and calorie restriction: A triple-blind randomized controlled clinical trial.","Nonalcoholic fatty liver disease (NAFLD) is one of the most common noncommunicable diseases worldwide. The present study aimed to investigate the effects of oleoylethanolamide (OEA) supplementation combined with calorie restriction on inflammation, body composition, and hepatic fibrosis among obese patients with NAFLD. In this 12-week randomized clinical trial, 76 obese patients newly diagnosed with NAFLD were randomly allocated into either OEA or placebo group. The weight-loss diet was also designed for both groups. Pre- and postintervention messenger RNA expression levels of the transcription factor nuclear factor-κB (NF-κB), interleukin-6 (IL-6) and IL-10, body composition, and NAFLD fibrosis score were assessed. At the end of the study, the OEA group showed lower NF-κB and IL-6 expression levels compared to the placebo (p < .01). However, IL-10 expression level was approximately twofold higher in the OEA group compared to the placebo group (p = .008). A significant reduction was observed in the fat mass of the OEA group compared to the placebo (p = .044) postintervention. In addition, OEA supplementation led to a significant increase in fat-free mass in the OEA group compared to the placebo (p = .032). A remarkable increase was observed in resting metabolic rate (RMR) in the OEA group (p = .009); however, it was not found in the placebo group. There were no significant between-group differences in RMR postintervention. In addition, no significant within-and between-group differences were observed in the NAFLD fibrosis score at the end of the trial. Treatment with OEA along with weight-loss intervention could significantly improve inflammation and body composition in patients with NAFLD.",2020,"At the end of the study, the OEA group showed lower NF-κB and IL-6 expression levels compared to the placebo (p < .01).","['76 obese patients newly diagnosed with NAFLD', 'patients with NAFLD', 'obese patients with NAFLD']","['OEA or placebo', 'OEA supplementation', 'OEA', 'oleoylethanolamide supplementation and calorie restriction', 'oleoylethanolamide (OEA) supplementation combined with calorie restriction', 'placebo']","['weight-loss diet', 'RNA expression levels of the transcription factor nuclear factor-κB (NF-κB), interleukin-6 (IL-6) and IL-10, body composition, and NAFLD fibrosis score', 'IL-10 expression level', 'fat-free mass', 'inflammation and body composition', 'Expression of NF-κB, IL-6, and IL-10 genes, body composition, and hepatic fibrosis', 'Pre- and postintervention messenger', 'resting metabolic rate (RMR', 'NF-κB and IL-6 expression levels', 'fat mass', 'RMR postintervention', 'NAFLD fibrosis score', 'inflammation, body composition, and hepatic fibrosis']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0335218', 'cui_str': 'Messenger'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",76.0,0.168151,"At the end of the study, the OEA group showed lower NF-κB and IL-6 expression levels compared to the placebo (p < .01).","[{'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Department of Clinical Nutrition, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saghafi-Asl', 'Affiliation': 'Department of Clinical Nutrition, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Abolhassan', 'Initials': 'A', 'LastName': 'Shakeri-Bavil', 'Affiliation': 'Department of Radiology, Imam Reza Teaching Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Farrin', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cellular physiology,['10.1002/jcp.29870'] 2146,32573054,Acute effects of a very low nicotine content cigarette on laboratory smoking lapse: Impacts of nicotine metabolism and nicotine dependence.,"Reducing cigarette nicotine content to nonaddictive levels facilitates smoking cessation; however, very low nicotine content cigarettes (VLNCs) may not be equally effective across heterogeneous smokers. We evaluated the impact of acute VLNC smoking versus control (sham puffs) on craving, withdrawal and smoking lapse behaviour and whether genetically influenced differences in nicotine metabolism and individual differences in nicotine dependence moderate observed effects. Thirty-three overnight-abstinent smokers (15 slow vs. 17 normal nicotine metabolizers; 17 low vs. 16 high nicotine dependence) smoked a 0.05-mg nicotine VLNC during one session and took sham VLNC puffs during another session, in a counterbalanced order. Craving and withdrawal were assessed before and after smoking and sham puffing. Next, participants completed the McKee Smoking Lapse Task, which measures ability to resist smoking and quantity of ad libitum smoking. VLNC (vs. sham) reduced craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking. VLNC-induced reduction in craving for positive reinforcement was greater in slow (vs. normal) metabolizers. Nicotine metabolism did not moderate any other VLNC responses. High-dependence (vs. low-dependence) participants engaged in greater ad lib smoking across VLNC and sham conditions. Nicotine dependence did not moderate VLNC responses. VLNC reduced craving, withdrawal and smoking lapse behaviour. Individual differences in nicotine metabolism and dependence had a minimal impact on VLNC responses; however, VLNCs were less effective at reducing craving for positive reinforcement among normal (vs. slow) metabolizers. These findings suggest that desirable VLNC effects may extend across heterogeneous groups of smokers.",2020,"VLNC (vs. sham) reduced craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking.",['Thirty-three overnight-abstinent smokers (15 slow vs. 17 normal nicotine metabolizers; 17 low vs. 16 high nicotine dependence) smoked a 0.05-mg'],"['nicotine VLNC', 'VLNC', 'low nicotine content cigarette']","['laboratory smoking lapse', 'craving, withdrawal and smoking lapse behaviour', 'craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking', 'McKee Smoking Lapse Task, which measures ability to resist smoking and quantity of ad libitum smoking', 'Craving and withdrawal', 'Nicotine metabolism', 'craving for positive reinforcement', 'VLNC reduced craving, withdrawal and smoking lapse behaviour']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0032741', 'cui_str': 'Positive reinforcement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.0256903,"VLNC (vs. sham) reduced craving and withdrawal, increased ability to resist smoking and reduced ad libitum smoking.","[{'ForeName': 'Hera E', 'Initials': 'HE', 'LastName': 'Schlagintweit', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Hendershot', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",Addiction biology,['10.1111/adb.12930'] 2147,32573121,Pneumatic retinopexy preceded by drainage of subretinal fluid for the treatment of severe bullous retinal detachment.,"PURPOSE To compare the efficacy and safety outcomes of scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP), a modified pneumatic retinopexy technique, in which, before gas injection, subretinal fluid is drained with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber, for the treatment of severe superior bullous rhegmatogenous retinal detachment (SBRD). METHODS This prospective, randomized, comparative study included 58 eyes with severe SBRD that were randomized 1:1 to undergo SB or DIP. The main outcome measures included success rate, visual acuity, mean change in refractive error and surgery duration. RESULTS The primary anatomic success rate was 93% for both procedures. Both groups showed significantly improved visual acuity after surgery. The change in refractive error and surgery duration was significantly higher in the SB group. Drainage-injection-pneumoretinopexy (DIP) appeared to be less traumatic, but with a longer persistence of subretinal fluid in a greater number of patients. CONCLUSION Our findings suggested that both SB and DIP are safe and effective treatments yielding functional and anatomical recovery in patients with severe SBRD. However, the DIP technique may be easier and less costly, with a success rate similar to that of SB.",2020,The change in refractive error and surgery duration was significantly higher in the SB group.,"['severe bullous retinal detachment', '58 eyes with severe SBRD', 'severe superior bullous rhegmatogenous retinal detachment (SBRD', 'patients with severe SBRD']","['balanced salt solution (BSS', 'Pneumatic retinopexy', 'scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP', 'Drainage-injection-pneumoretinopexy (DIP', 'SB or DIP', 'SB and DIP']","['visual acuity', 'refractive error and surgery duration', 'primary anatomic success rate', 'success rate, visual acuity, mean change in refractive error and surgery duration']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205405', 'cui_str': 'Bullous'}, {'cui': 'C0035305', 'cui_str': 'Retinal detachment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}, {'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0036411', 'cui_str': 'Scleral buckling'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",58.0,0.169432,The change in refractive error and surgery duration was significantly higher in the SB group.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morescalchi', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Gandolfo', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Carnazza', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Bahja', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Eye Clinic, Department of Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Brescia, Italy.'}]",Acta ophthalmologica,['10.1111/aos.14528'] 2148,32573156,[Evaluation of therapeutic effects of the ultramicro needle knife combined with cervical spine fine adjusting on youth cervical curvature abnormality case].,"OBJECTIVE To study the therapeutic effects of the ultramicro needle-knife combine with cervical spine fine adjusting on youth cervical curvature abnormality case. METHODS From November 2016 to October 2018, 88 young patients with abnormal curvature of cervical spine were treated. Due to loss of follow up, 86 cases were actually completely including 37 males and 49 females, ranging in age from 20 to 40 years old, with an average of (30.55±5.21) years old, and the course of disease ranged from 1 to 42 months, with a mean of (14.21±7.38) months. All the patients were divided into two groups:treatment group (44 cases) and control group (42 cases). The patients in the treatment group were treated with ultramicro needle-knife and cervical spine fine adjusting, and the patients in the control group were treated with conventional acupuncture and manipulation. The treatments were done 1 time per week in the treatment group while 3 times per week in control group every week, with a duration of 3 weeks for both groups. Before treatment, 3 weeks after treatment, and at the end of 1 month follow-up, the score of neck pain questionnaire(NPQ), range of the motion(ROM) in the cervical region and the D values of cervical physiological curvature were recorded. The efficacy at the end of treatment and in the follow up was evaluated. During the treatment, the patients were also required to correct the bad posture in daily life, to sleep in a low pillow position, and put a moderately columnar pillow behind the neck for 0.5 hours every morning and evening. RESULTS Two patients in the control group were dropped out after 3 weeks treatment. No adverse reactions were found in the 2 groups during the treatment period. Compared with those before treatment, all scores at all the observation time points were significantly improved between two groups after treatment(all P <0.05). The NPQ scores of cervical symptoms were different significantly between two groups(all P <0.05). The changing range of the the NPQ score of cervical symptoms and cervical spine alignment curve of the treatment group were better than those of the control group ( P <0.05).There was statistical difference in NPQ scores between different time points, in the other words, there was time effect( F =203.63, P =0.000). There was interaction between time factor and group factor( F =4.964, P =0.012). There was no statistical difference in the changing range of the ROM score between two groups (all P >0.05). There was statistical difference in ROM scores between different time points, there was time effect ( F =240.32), P =0.000). There was no interaction between time factor and group factor ( F =0.311, P =0.734). The effective rate of the treatment group and control group were 90.91%(40 / 44) and 80.95%(34 / 42) respectively, the treatment group was more effective than the control group ( P <0.05). During the follow-up period, the effective rate of the treatment group and the control group were 84.09%(37 / 44) and 76.19%(32 / 42) respectively. Obviously, the difference of total effective rate between two groups had no statistical signification( P >0.05) in the follow-up duration. CONCLUSION The method of needle knife combined with cervical spine fine adjusting has a better therapeutic efficiency than conventional acupuncturecombined with manipulation in treating youth cervical curvature abnormality patients. Because this novel method can recover the cervical curvature, relieve the neck pain, and improve cervical mobility.",2020,There was no statistical difference in the changing range of the ROM score between two groups (all P >0.05).,"['86 cases were actually completely including 37 males and 49 females, ranging in age from 20 to 40 years old, with an average of (30.55±5.21) years old, and the course of disease ranged from 1 to 42 months, with a mean of (14.21±7.38) months', 'youth cervical curvature abnormality case', 'youth cervical curvature abnormality patients', 'From November 2016 to October 2018, 88 young patients with abnormal curvature of cervical spine were treated']","['conventional acupuncturecombined with manipulation', 'conventional acupuncture and manipulation', 'ultramicro needle-knife and cervical spine fine adjusting', 'needle knife combined with cervical spine fine adjusting', 'ultramicro needle knife combined with cervical spine fine adjusting', 'ultramicro needle-knife combine with cervical spine fine adjusting']","['NPQ scores of cervical symptoms', 'total effective rate', 'NPQ score of cervical symptoms and cervical spine alignment curve', 'score of neck pain questionnaire(NPQ), range of the motion(ROM) in the cervical region and the D values of cervical physiological curvature', 'effective rate', 'ROM scores', 'adverse reactions', 'ROM score', 'observation time points', 'NPQ scores']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0333063', 'cui_str': 'Abnormal curvature'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",88.0,0.0154139,There was no statistical difference in the changing range of the ROM score between two groups (all P >0.05).,"[{'ForeName': 'Hai-Ping', 'Initials': 'HP', 'LastName': 'Hong', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Yu-Yun', 'Initials': 'YY', 'LastName': 'Xu', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.007'] 2149,32573157,[Relationship between lower limb alignment distribution and short-term clinical results after primary total knee arthroplasty in patients with varying degrees of knee varus].,"OBJECTIVE To analyze the relationship between the distribution of lower limb alignment and short term clinical efficacy in patients with varus-type osteoarthritis after primary total knee arthroplasty (TKA). METHODS From December 2016 to March 2018, 87 patients (101 knees) with knee osteoarthritis were treated with the first total knee arthroplasty by the same medical group, including 21 males(25 knees) and 66 females(76 knees), ranging in age from 51 to 85 years old, with a mean of (67.6±7.0) years old. According to the difference of hip knee ankle angle (HKA) after total knee arthroplasty, the patients were divided into 4 groups:neutral position group (group A), -3°≤HKA≤3°, 50 knees;slight varus group (group B), 3°< HKA<6°, 20 knees;severe varus group (group C), HKA≥6°, 20 knees;valgus group (group D), HKA<- 3°, 11 knees. The preoperative sex, age, body mass index, operative side, preoperative and postoperative knee joint activity, HSS score, KSS clinical and functional score were compared among the 4 groups, and the relationship between the force line distribution of femoral and tibial prosthesis and the recent clinical effect was compared. RESULTS All the patients were followed up with a mean duration of(18.4±4.0) months. The range of motion of knee joint, HSS and KSS scores at the latest follow-up after operation in the 4 groups were higher than those before operation, and the difference was statistically significant ( P <0.001). There were significant differences in HSS and KSS scores among the 4 groups at the latest follow up ( P <0.05);and the results in group A were better than those in group C and group D ( P <0.05);the results in group B were better than those in group C and group D ( P < 0.05);there was no significant difference between group A and group B or group C and group D( P >0.05). There was no significant difference in knee joint activity among the 4 groups. The score of femoral prosthesis force line within ±3°was better than that of the other group ( P <0.05), and the score of tibia prosthesis force line had no significant difference between within ±3° group and other group ( P >0.05). CONCLUSION The short term clinical efficacy of patients with knee varus osteoarthritis after primary total knee arthroplasty is related to the distribution of lower limbs alignment. The short-term clinical efficacy of slight inversion position can be similar to that of neutral position. The force line distribution of femoral prosthesis is related to the short term clinical efficacy after primary knee arthroplasty.",2020,the results in group A were better than those in group C and group D ( P <0.05);the results in group B were better than those in group C and group D ( P,"['87 patients (101 knees) with knee osteoarthritis were treated with the first total knee arthroplasty by the same medical group, including 21 males(25 knees) and 66 females(76 knees), ranging in age from 51 to 85 years old, with a mean of (67.6±7.0) years old', 'From December 2016 to March 2018', 'patients with varus-type osteoarthritis after primary total knee arthroplasty (TKA', 'patients with knee varus osteoarthritis after primary total knee arthroplasty', 'primary total knee arthroplasty in patients with varying degrees of knee varus', 'hip knee ankle angle (HKA) after total knee arthroplasty, the patients were divided into 4 groups']","['neutral position group (group A), -3°≤HKA≤3°, 50 knees;slight varus group (group B), 3°< HKA<6°, 20 knees;severe varus group (group C), HKA≥6°, 20 knees;valgus group', 'slight inversion position']","['knee joint activity', 'HSS and KSS scores', 'score of femoral prosthesis force line within ±3°', 'score of tibia prosthesis force line', 'range of motion of knee joint, HSS and KSS scores', 'preoperative sex, age, body mass index, operative side, preoperative and postoperative knee joint activity, HSS score, KSS clinical and functional score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0136376,the results in group A were better than those in group C and group D ( P <0.05);the results in group B were better than those in group C and group D ( P,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Xuzhou Medical University, Xuzhou 221004, Jiangsu, China.'}, {'ForeName': 'Shi-Zhuang', 'Initials': 'SZ', 'LastName': 'Xu', 'Affiliation': 'Xuzhou Medical University, Xuzhou 221004, Jiangsu, China.'}, {'ForeName': 'Guan-Jie', 'Initials': 'GJ', 'LastName': 'Yang', 'Affiliation': 'Xuzhou Medical University, Xuzhou 221004, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Xuzhou Medical University, Xuzhou 221004, Jiangsu, China.'}, {'ForeName': 'Da-di', 'Initials': 'DD', 'LastName': 'Li', 'Affiliation': 'Xuzhou Medical University, Xuzhou 221004, Jiangsu, China.'}, {'ForeName': 'Kai-Jin', 'Initials': 'KJ', 'LastName': 'Guo', 'Affiliation': 'Xuzhou Medical University, Xuzhou 221004, Jiangsu, China.'}, {'ForeName': 'Feng-Chao', 'Initials': 'FC', 'LastName': 'Zhao', 'Affiliation': 'Xuzhou Medical University, Xuzhou 221004, Jiangsu, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.008'] 2150,32573159,[Zheng's massage combined with electroacupuncture in the treatment of reflex sympathetic dystrophy syndrome of the wrist].,"OBJECTIVE To observe the clinical effects of zheng's massage combined with electroacupuncture in the treatment ofreflex sensory dystrophy syndrome of the wrist. METHODS From October 2016 to September 2018, 48 cases of reflex sensory dystrophy syndrome of the wrist were divided into the observation group and the control group. In the observation group, there were 24 cases, including 10 males and 14 females, ranging in age from 54 to 76 years old, with an average age of (61.41 ±7.90) years old. The patients in the observation group were treated with Zheng's massage combined with electroacupuncture. The control group consisted of 24 patients, including 9 males and 15 females, ranging in age from 52 to 75 years old, with an averageage of (58.71±8.11 ) years old. The patients in the control group were treated with electroacupuncture alone. All the patients in both groups were treated for 6 weeks. The clinical symptoms and signs, visual anglogue scale (VAS), Cooney wrist score and clinical efficacy evaluation were compared between the two groups before and after treatment, and statistical analysis was conducted. RESULTS After 6 weeks of treatment, VAS in the control group was 4.9±1.8, and Cooney wrist score was 74.63±1.72; VAS in the observation group was 2.2±1.4, and Cooney wrist score was 86.31±2.53. The comprehensive scores of VAS and Cooney wrist joint between two groups were improved after treatment, and the observation group was better than control group( P <0.05). The curative effect of the observation group was better than that of the control group. CONCLUSION Zheng's massage combined with electroacupuncture has the following advantages in the treatment of reflex sympathetic dystrophy syndrome of the wrist, such as small trauma, patients' willingness promoting functional rehabilitation, which is worthy of clinical promotion.",2020,"The curative effect of the observation group was better than that of the control group. ","['reflex sympathetic dystrophy syndrome of the wrist', '24 cases, including 10 males and 14 females, ranging in age from 54 to 76 years old, with an average age of (61.41 ±7.90) years old', '24 patients, including 9 males and 15 females, ranging in age from 52 to 75 years old, with an averageage of (58.71±8.11 ) years old', 'From October 2016 to September 2018, 48 cases of reflex sensory dystrophy syndrome of the wrist']","['electroacupuncture alone', 'electroacupuncture', ""Zheng's massage combined with electroacupuncture""]","['clinical symptoms and signs, visual anglogue scale (VAS), Cooney wrist score and clinical efficacy evaluation', 'Cooney wrist score', 'comprehensive scores of VAS and Cooney wrist joint', 'curative effect']","[{'cui': 'C0034931', 'cui_str': 'Complex regional pain syndrome type I'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0173629,"The curative effect of the observation group was better than that of the control group. ","[{'ForeName': 'Hao-Chen', 'Initials': 'HC', 'LastName': 'Tang', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Liu-Gang', 'Initials': 'LG', 'LastName': 'Tang', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Yuan-Dong', 'Initials': 'YD', 'LastName': 'Cheng', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Tai', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.010'] 2151,32573161,[A case-control study of unicompartmental knee arthroplasty with mobile and fixed platform for the treatment of single compartment osteoarthritis of knee].,"OBJECTIVE To compare and analyze the early clinical outcomes of unicompartmental knee arthroplasty with mobile and fixed platform for the treatment of single compartment osteoarthritis of knee. METHODS From January 2013 to December 2014, 86 cases (92 knees) of knee osteoarthritis with single compartment (medial) were randomly divided into two groups. One group consisted of 42 patients, including 18 males and 24 females, underwent unicompartmental knee arthroplasty with fixed platform prosthesis; the other group consisted of 44 patients, including 20 males and 24 females, underwent unicompartmental knee arthroplasty with mobile platform prosthesis. The surgery was performed by the same group of doctors. The operation time, blood loss, ROM, KSS and HSS scores of knee joint before and after surgery were recorded and the clinical follow up was completed. RESULTS The follow-up duration of the two groups ranged from 8 to 26 months, with an average of (18.20± 4.23) months. During the follow-up period, the periprosthetic fracture was found in 1 patient in the fixed platform group 1 year after operation, and polyethylene liner dislocation was found in 1 patient in the mobile platform group. No complications such as poor wound healing, periprosthetic infection or sterile prothesis loosening were found in all cases. In the fixed platform group, the operation time was (90.05±6.59) minutes and the blood loss was (53.76±6.04) ml. In the mobile platform group, the operation time was (90.73±6.74) minutes and the blood loss was (54.34±6.27) ml. In the fixed platform group, the ROM of knee increased from preoperative (94.52±4.54) degree to postoperative (104.64±4.42) degree. In the mobile platform group, the ROM of knee increased from preoperative (95.05±4.87) degree to postoperative (105.07±4.33) degree. In the fixed platform group, the KSS score increased from preoperative 48.69±5.68 to postoperative 83.55±5.37. In the mobile platform group, the KSS score increased from preoperative 49.39±5.68 to postoperative 84.11±6.14. In the fixed platform group, the HSS score increased from preoperative 45.45±3.62 to postoperative 84.55±6.08. In the mobile platform group, the HSS score increased from preoperative 45.93±4.01 to postoperative 85.16±6.30. There was no significant difference between the two groups. CONCLUSION There is no significant difference in the early outcome of unicondylar prosthesis with fixed and mobile platforms in the treatment of single compartmental osteoarthritis of knee. The long-term complications and revision rates of the two prostheses need further multi center and large-sample clinical study.",2020,"No complications such as poor wound healing, periprosthetic infection or sterile prothesis loosening were found in all cases.","['From January 2013 to December 2014, 86 cases (92 knees) of knee osteoarthritis with single compartment (medial', '42 patients, including 18 males and 24 females, underwent', '44 patients, including 20 males and 24 females, underwent', 'single compartment osteoarthritis of knee']","['unicompartmental knee arthroplasty with mobile platform prosthesis', 'unicompartmental knee arthroplasty with fixed platform prosthesis', 'unicompartmental knee arthroplasty with mobile and fixed platform']","['wound healing, periprosthetic infection or sterile prothesis loosening', 'ROM of knee', 'HSS score', 'operation time, blood loss, ROM, KSS and HSS scores of knee joint', 'KSS score', 'periprosthetic fracture', 'operation time', 'blood loss']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C2609162', 'cui_str': 'Periprosthetic fracture'}]",,0.0206297,"No complications such as poor wound healing, periprosthetic infection or sterile prothesis loosening were found in all cases.","[{'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Wei', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Guan-Jun', 'Initials': 'GJ', 'LastName': 'Yi', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Chong-Xi', 'Initials': 'CX', 'LastName': 'Chai', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.012'] 2152,32573261,The fate of positive intraoperative cultures following conversion total hip arthroplasty.,"INTRODUCTION The objectives of this study are to report the rates of positive intraoperative cultures obtained during conversion total hip arthroplasty (THA) according to index surgery, and to describe the natural history of treatment for a consecutive series of patients with unexpected positive intraoperative cultures during conversion THA. METHODS We reviewed all patients at 2 institutions undergoing conversion THA from prior open reduction and internal fixation (ORIF) of acetabular and hip fractures or hemiarthroplasty for displaced femoral neck fractures from 2011 to 2018. Intraoperative cultures were taken in 105 patients. Positive intraoperative cultures during conversion were recorded and managed with an infectious diseases consult. The outcomes including PJI at 90 days and 1 year follow-up were documented. RESULTS Overall, 19 of 105 patients (18%) undergoing conversion THA had positive intraoperative cultures, with the highest rates in the hemiarthroplasty 7/16 (44%) and acetabular ORIF 9/48 (19%) groups. All 19 patients were initially treated conservatively: 8 received IV antibiotics, 10 received no additional therapy, and 1 received oral antibiotics. 4/9 acetabular fracture conversions developed PJI at 1 year, with 3 requiring multiple irrigation and debridement/polyethylene exchanges to control the infection while the 4th patient required 2-stage exchange. There were no 1-year PJI from any of the other index procedures after conversion. All 7 hemiarthroplasty patients with positive cultures were treated to resolution with 4-8 weeks IV antibiotics alone. CONCLUSIONS Patients undergoing conversion THA from prior hip or acetabular fracture have a high rate of positive intraoperative cultures. As such, all patients undergoing conversion THA from prior hip or acetabular fracture fixation should undergo thorough diagnostic workup prior to surgery, and have intraoperative cultures obtained during surgery if infection remains suspicious. Further work should be performed to develop MSIS criteria for preoperative management of patients undergoing conversion THA.",2020,There were no 1-year PJI from any of the other index procedures after conversion.,"['All 7 hemiarthroplasty patients with positive cultures', 'All 19 patients were initially treated conservatively: 8 received', 'patients with unexpected positive intraoperative cultures during conversion THA', 'patients at 2 institutions undergoing conversion THA from prior open reduction and internal fixation (ORIF) of acetabular and hip fractures or hemiarthroplasty for displaced femoral neck fractures from 2011 to 2018', 'Patients undergoing conversion', '105 patients', 'conversion total hip arthroplasty', 'patients undergoing conversion THA']","['conversion total hip arthroplasty (THA', 'THA', 'IV antibiotics, 10 received no additional therapy, and 1 received oral antibiotics']","['1-year PJI', 'positive intraoperative cultures']","[{'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0345893', 'cui_str': 'Juvenile polyposis syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",19.0,0.0298693,There were no 1-year PJI from any of the other index procedures after conversion.,"[{'ForeName': 'Kyle H', 'Initials': 'KH', 'LastName': 'Cichos', 'Affiliation': 'Department of Orthopaedic Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Detweiler', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Parvizi', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'Department of Orthopaedic Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Heatherly', 'Affiliation': 'UAB School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Elie S', 'Initials': 'ES', 'LastName': 'Ghanem', 'Affiliation': 'Department of Orthopaedic Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700020936628'] 2153,32573271,Effects of two different types of ankle-foot orthoses on gait outcomes in patients with subacute stroke: a randomized crossover trial.,"OBJECTIVE To identify whether patients in the subacute stage of stroke, with foot drop, would have better gait outcomes when using a double-adjustable AFO (DA AFO) or a posterior leaf spring AFO (PLS AFO) at baseline without practice and to determine whether one week of practice would significantly change gait outcomes with either of the AFOs. DESIGN Within-subject 2 × 2 repeated measures design. SETTING Postacute and outpatient rehabilitation center. PARTICIPANTS Twenty individuals with mean age of 57 years (SD: 12.0 years) with subacute stroke. INTERVENTIONS Participants were measured using DA AFO and PLS AFO at baseline. Follow-up measurements were taken after one week of practice with each type of AFO in randomly assigned order. OUTCOME MEASURES Gait endurance (6-Minute Walk Test (6MWT)), gait symmetry, and gait velocity at self-selected and fast-paced velocity measured using GAITRite gait analysis system and patient report of AFO preference. RESULTS At baseline, no significant differences were found between the 2 AFOs ( P  > 0.05). There was no significant interaction ( P  > 0.05) of AFO and practice for gait endurance, symmetry, and velocity. Main effect of practice was significant for gait endurance ( P  < 0.001), self-selected velocity ( P  = 0.001), and fast-paced velocity ( P  < 0.001). In all, 16 participants preferred using DA AFO for walking. CONCLUSIONS No difference between DA AFO and PLS AFO was found on measures of gait endurance, symmetry, and velocity at baseline or after practice. With practice over time, participants improved in gait endurance and velocity regardless of AFO type.",2020,"There was no significant interaction ( P  > 0.05) of AFO and practice for gait endurance, symmetry, and velocity.","['Postacute and outpatient rehabilitation center', 'Twenty individuals with mean age of 57\u2009years (SD: 12.0 years) with subacute stroke', '16 participants preferred using DA AFO for walking', 'patients in the subacute stage of stroke, with foot drop', 'patients with subacute stroke']",['ankle-foot orthoses'],"['Gait endurance (6-Minute Walk Test (6MWT)), gait symmetry, and gait velocity at self-selected and fast-paced velocity measured using GAITRite gait analysis system and patient report of AFO preference', 'gait endurance, symmetry, and velocity', 'fast-paced velocity', 'gait endurance and velocity regardless of AFO type', 'self-selected velocity', 'DA AFO and PLS AFO', 'gait endurance', 'gait outcomes']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0085684', 'cui_str': 'Foot-drop'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3874714', 'cui_str': 'Gait analysis system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",20.0,0.0698814,"There was no significant interaction ( P  > 0.05) of AFO and practice for gait endurance, symmetry, and velocity.","[{'ForeName': 'Priya Sibi', 'Initials': 'PS', 'LastName': 'Karakkattil', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Frisco, TX, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Trudelle-Jackson', 'Affiliation': ""School of Physical Therapy, Texas Woman's University Institute of Health Sciences, Dallas, TX, USA.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Medley', 'Affiliation': ""School of Physical Therapy, Texas Woman's University Institute of Health Sciences, Dallas, TX, USA.""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Swank', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}]",Clinical rehabilitation,['10.1177/0269215520927738'] 2154,32567654,"Impact of Succinct Training on Open Cricothyrotomy Performance: A Randomized, Prospective, Observational Study of U.S. Army First Responders.","INTRODUCTION Primary airway failure has become the second most common cause of potentially survivable battlefield fatality. Cricothyrotomy is taught to all U.S. military providers as a means of securing an airway in extremis. However, retrospective studies show that cricothyrotomy failure rates for U.S. military first responders performing the procedure in combat is 33%. Our hypothesis was that these rates could be improved. MATERIALS AND METHODS We conducted a randomized, prospective, observational study to evaluate the effects of inexpensive, succinct training on open cricothyrotomy performance by studying two unique U.S. Army First Responder participant groups. One participant group consisted of regular U.S. Army Medics (68 Ws). The second group was Special Operations Combat Medics. We evaluated both groups' baseline ability to correctly perform a cricothyrotomy and then randomly assigned individuals within each group to either a training or practice group. RESULTS The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline. CONCLUSION With one manikin, a qualified trainer, and $35 worth of expendable supplies, 10 medics could be trained in the procedure in just 2-3 hours. Our study suggests that this simple intervention has the potential to significantly improve U.S. Army First Responders' ability to correctly perform an open cricothyrotomy and drastically decrease the time needed to perform this lifesaving procedure correctly, possibly saving one in four potentially survivable combat casualties suffering from airway compromise.",2020,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline. ",[],"['training or practice group', 'regular U.S. Army Medics', 'Cricothyrotomy', 'Succinct Training', 'inexpensive, succinct training']","['procedural success rates', 'Open Cricothyrotomy Performance', 'average time-to-correct-placement']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030450', 'cui_str': 'Paramedical Personnel'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.0179072,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline. ","[{'ForeName': 'Kurtis L', 'Initials': 'KL', 'LastName': 'Muller', 'Affiliation': 'Special Warfare Medical Group (Airborne) 1975 Combat Medic Rd, Fort Bragg NC 28310.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Facciolla', 'Affiliation': '1st Special Forces Command (Airborne) 1625 Reilly Rd, Fort Bragg, NC 28310.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Monti', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Cronin', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}]",Military medicine,['10.1093/milmed/usaa035'] 2155,32567984,Comparative study between topical tranexamic acid alone versus its combination with autologous platelet rich plasma for treatment of melasma.,"Background: Tranexamic acid is a promising drug for melasma treatment, but its topical formulation has limited efficacy. Its use as liposome based cream or in combination with other modalities might help to achieve better results. Objective: Comparing efficacy of topical tranexamic acid 5% in liposome base alone versus its combination with intradermal platelet rich plasma (PRP) for melisma treatment. Methods: Forty female patients with melasma were divided randomly into 2 equal groups who were treated with topical tranexamic acid 5% cream twice daily for 12 weeks and group B received additional intradermal injections of PRP every 3 weeks throughout the treatment period. Evaluation was done through modified MASI score and patient satisfaction after one month from the end of treatment. Results: Both groups showed significant improvement of modified MASI score after treatment. Significantly better treatment response and patient satisfaction were detected in patients of group B ( p  = .024, .029). The side effects of PRP were mild and tolerable and tranexamic acid was well tolerated. Conclusion: 5% topical tranexamic acid in liposome base is thought to be safe and effective modality for treatment of melasma. PRP is advisable as an autologous safe elixir which boosts the therapeutic effect of tranexamic acid.",2020,"Significantly better treatment response and patient satisfaction were detected in patients of group B ( p  = .024, .029).","['melasma', 'Forty female patients with melasma']","['additional intradermal injections of PRP', 'Tranexamic acid', 'PRP', 'topical tranexamic acid', 'tranexamic acid', 'topical tranexamic acid 5% cream']","['modified MASI score and patient satisfaction', 'treatment response and patient satisfaction', 'tolerated', 'modified MASI score']","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",40.0,0.0364062,"Significantly better treatment response and patient satisfaction were detected in patients of group B ( p  = .024, .029).","[{'ForeName': 'Mohamed Mahmoud', 'Initials': 'MM', 'LastName': 'Gamea', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Doha Ali', 'Initials': 'DA', 'LastName': 'Kamal', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmed Atef', 'Initials': 'AA', 'LastName': 'Donia', 'Affiliation': 'Pharmaceutical Technology Department, Faculty of Pharmacy, Menoufia University, Shibin el Kom, Egypt.'}, {'ForeName': 'Doaa Salah', 'Initials': 'DS', 'LastName': 'Hegab', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1781755'] 2156,32567996,Analysis of subjective perception and influencing factors of different inclusive education models among prelingually deaf children with a cochlear implant.,"OBJECTIVE We aimed to explore the educational outcome and influencing factors of ongoing verbal rehabilitation training together with inclusive education among prelingually deaf children with a cochlear implant. METHODS Prelingually deaf children who underwent cochlear implantation, rehabilitation, and had inclusive education placement were randomly divided into two groups: one group received continuous verbal rehabilitation training under inclusive education status; the other group did not receive this training. Speech discrimination scores were determined. RESULTS Among 60 included children, subjectively perceived academic adaptability, peer relations, initiative communication, and teacher's involvement under inclusive education, as well as speech discrimination scores, were all significantly different between groups. Continuous verbal rehabilitation training influenced the subjective perception of children and resulted in higher speech discrimination scores and more positive subjective perception. Subjective perception was not significantly correlated with chronological age, sex, age at the time of cochlear implantation, or duration of inclusive education. CONCLUSION Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.",2020,Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.,"['prelingually deaf children with cochlear implants', 'Prelingually deaf children who underwent cochlear implantation, rehabilitation, and had inclusive education placement', 'prelingually deaf children with a cochlear implant']","['continuous verbal rehabilitation training under inclusive education status; the other group did not receive this training', 'verbal rehabilitation training', 'Continuous verbal rehabilitation training']","['Speech discrimination scores', 'positive subjective perception', 'Subjective perception', ""subjectively perceived academic adaptability, peer relations, initiative communication, and teacher's involvement under inclusive education, as well as speech discrimination scores"", 'higher speech discrimination scores']","[{'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0205250', 'cui_str': 'High'}]",60.0,0.0144398,Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.,"[{'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Qiao', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'Shanxi University of Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Tong-Li', 'Initials': 'TL', 'LastName': 'Li', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Redentor S', 'Initials': 'RS', 'LastName': 'Mariano', 'Affiliation': 'Jose Rizal University, Mandaluyong City, Philippines.'}]",The Journal of international medical research,['10.1177/0300060520929855'] 2157,32568065,Sodium bicarbonate to improve physical function in patients over 60 years with advanced chronic kidney disease: the BiCARB RCT.,"BACKGROUND Advanced chronic kidney disease is common in older people and is frequently accompanied by metabolic acidosis. Oral sodium bicarbonate is used to treat this acidosis, but evidence is lacking on whether or not this provides a net gain in health or quality of life for older people. OBJECTIVES The objectives were to determine whether or not oral bicarbonate therapy improves physical function, quality of life, markers of renal function, bone turnover and vascular health compared with placebo in older people with chronic kidney disease and mild acidosis; to assess the safety of oral bicarbonate; and to establish whether or not oral bicarbonate therapy is cost-effective in this setting. DESIGN A parallel-group, double-blind, placebo-controlled randomised trial. SETTING The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals. PARTICIPANTS Participants were adults aged ≥ 60 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of < 22 mmol/l. INTERVENTIONS Eligible participants were randomised 1 : 1 to oral sodium bicarbonate or matching placebo. Dosing started at 500 mg three times daily, increasing to 1 g three times daily if the serum bicarbonate concentration was < 22 mmol/l at 3 months. MAIN OUTCOME MEASURES The primary outcome was the between-group difference in the Short Physical Performance Battery score at 12 months, adjusted for baseline. Other outcome measures included generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide. All adverse events were recorded, including commencement of renal replacement therapy. For the health economic analysis, the incremental cost per quality-adjusted life-year was the main outcome. RESULTS In total, 300 participants were randomised, 152 to bicarbonate and 148 to placebo. The mean age of participants was 74 years and 86 (29%) were female. Adherence to study medication was 73% in both groups. A total of 220 (73%) participants were assessed at the 12-month visit. No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points; p  = 0.15). No significant treatment benefit was seen for any of the secondary outcomes. Adverse events were more frequent in the bicarbonate arm (457 vs. 400). Time to commencement of renal replacement therapy was similar in both groups (hazard ratio 1.22, 95% confidence interval 0.74 to 2.02; p  = 0.43). Health economic analysis showed higher costs and lower quality of life in the bicarbonate arm at 1 year, with additional costs of £564 (95% confidence interval £88 to £1154) and a quality-adjusted life-year difference of -0.05 (95% confidence interval -0.08 to -0.01); placebo dominated bicarbonate under all sensitivity analyses for incremental cost-effectiveness. LIMITATIONS The trial population was predominantly white and male, limiting generalisability. The increment in serum bicarbonate concentrations achieved was small and a benefit from larger doses of bicarbonate cannot be excluded. CONCLUSIONS Oral sodium bicarbonate did not improve a range of health measures in people aged ≥ 60 years with chronic kidney disease category 4 or 5 and mild acidosis, and is unlikely to be cost-effective for use in the NHS in this patient group. Once other current trials of bicarbonate therapy in chronic kidney disease are complete, an individual participant meta-analysis would be helpful to determine which subgroups, if any, are more likely to benefit and which treatment regimens are more beneficial. TRIAL REGISTRATION Current Controlled Trials ISRCTN09486651 and EudraCT 2011-005271-16. The systematic review is registered as PROSPERO CRD42018112908. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 27. See the NIHR Journals Library website for further project information.",2020,"No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points; p  = 0.15).","['Participants were adults aged ≥\u200960 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of <\u200922\u2009mmol/l', 'older people with chronic kidney disease and mild acidosis', 'The mean age of participants was 74 years and 86 (29%) were female', '300 participants were randomised, 152 to', 'patients over 60 years with advanced chronic kidney disease', 'people aged ≥\u200960 years with chronic kidney disease category 4 or 5 and mild acidosis', 'The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals']","['Sodium bicarbonate', 'placebo dominated bicarbonate', 'bicarbonate', 'oral sodium bicarbonate or matching placebo', 'bicarbonate therapy', 'Oral sodium bicarbonate', 'placebo']","['Time to commencement of renal replacement therapy', 'higher costs and lower quality of life', 'physical function', 'Adverse events', 'range of health measures', 'Short Physical Performance Battery score', 'serum bicarbonate concentration', 'generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide', 'physical function, quality of life, markers of renal function, bone turnover and vascular health', 'serum bicarbonate concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",300.0,0.463179,"No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points; p  = 0.15).","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'AGE Research Group, NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation, Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Band', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Huey', 'Initials': 'H', 'LastName': 'Chong', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health and Genomics, Medical School, University of Dundee, Dundee, UK.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Hampson', 'Affiliation': ""Department of Clinical Chemistry and Metabolic Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'May Khei', 'Initials': 'MK', 'LastName': 'Hu', 'Affiliation': 'NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Lamb', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'The Immunoassay Biomarker Core Laboratory, University of Dundee, Dundee, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McNamee', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Plews', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rauchhaus', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'Ageing Clinical and Experimental Research, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Sumukadas', 'Affiliation': 'Department of Medicine for the Elderly, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Warwick', 'Affiliation': 'John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Avenell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24270'] 2158,32568092,An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial.,"BACKGROUND Although the most effective methods of contraception are available in Bolivia, unmet need for contraception among women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016). Mobile phones are a popular mode to deliver health behavior support. We developed a contraceptive behavioral intervention for young Bolivian women delivered by mobile phone and guided by behavioral science. The intervention consists of short instant messages sent through an app over 4 months. OBJECTIVE This trial aimed to evaluate the effect of the intervention on young Bolivian women's use of and attitudes toward the effective contraceptive methods available in Bolivia. METHODS This was a parallel group, individually randomized superiority trial with a 1:1 allocation ratio. Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish. The target sample size was 1310 participants. Participants allocated to the intervention had access to an app with standard family planning information and intervention messages. Participants allocated to the control group had access to the same app and control messages. Coprimary outcomes were use of effective contraception and acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion. Process outcomes included knowledge, perceived norms, personal agency, and intention. Outcomes were analyzed using logistic and linear regression. We also asked participants about physical violence. RESULTS A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception. There was no evidence that use differed between the groups (33% control vs 37% intervention; adjusted odds ratio [OR] 1.19, 95% CI 0.80 to 1.77; P=.40). There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06). There were no statistically significant differences in any of the secondary or process outcomes. The intervention dose received was low. In the control group, 2.8% (6/207) reported experiencing physical violence compared with 1.9% (4/202) in the intervention group (Fisher exact test P=.75). CONCLUSIONS This trial was unable to provide definitive conclusions regarding the effect of the intervention on use and acceptability of effective contraception because of under recruitment. Although we cannot strongly recommend implementation, the results suggest that it would be safe and may increase the acceptability of effective contraception if the intervention messages were offered alongside the download of the app. TRIAL REGISTRATION ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526.",2020,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","['1310 participants', 'women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016', 'A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception', 'Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish', 'Young Women in Bolivia', ""young Bolivian women's"", 'young Bolivian women delivered by', 'participants about physical violence']","['intervention had access to an app with standard family planning information and intervention messages', 'control group had access to the same app and control messages', 'Mobile Phone Instant Messaging', 'mobile phone and guided by behavioral science', 'contraceptive behavioral intervention']","['acceptability', 'experiencing physical violence', 'acceptability of effective contraception', 'effective contraception and acceptability of at least one method of effective contraception', 'knowledge, perceived norms, personal agency, and intention', 'effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1277145', 'cui_str': 'Reads Spanish'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005918', 'cui_str': 'Bolivia'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004940', 'cui_str': 'Behavioral Sciences'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",640.0,0.278254,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","[{'ForeName': 'Ona L', 'Initials': 'OL', 'LastName': 'McCarthy', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Aliaga', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Torrico Palacios', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Jhonny', 'Initials': 'J', 'LastName': 'López Gallardo', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Huaynoca', 'Affiliation': 'International Planned Parenthood Federation/Western Hemisphere Region, New York, NY, United States.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Leurent', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Irrfan', 'Initials': 'I', 'LastName': 'Ahamed', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of medical Internet research,['10.2196/14073'] 2159,32568172,Mobilisation efficacy in young patients with different stages of degenerative disc disease.,"BACKGROUND Lumbar vertebrae carry the greatest load from the spinal column, often leading to several pathologies, including degenerative disc disease (DDD), potentially, disturbing spinal movement patterns. Mobilisation increases hypomobile segment mobility, however there is little evidence on mobilisation in patients suffering with different types of DDD. OBJECTIVE To assess the efficacy of mobilisation in young patients with DDD, as diagnosed by MRI. METHODS Thirty patients (24-35 years) participated in this study, and were divided into two groups, based on progression levels of DDD diagnosed by MRI (protrusion-PRO/extrusion-EXT). Twenty sessions of sustained stretch mobilisation (grade III) were applied to both groups over four weeks. Numeric rating scale (NRS), Oswestry disability index (ODI), straight leg raise (SLR), passive lumbar extension (PLE) and lumbar range of motion (ROM) assessed outcome variables. Three trial stages were investigated: pre-therapy(1), post-therapy(2) and follow-up(3). RESULTS Age (p= 0.007) and NRS (p= 0.002) were significantly different before therapy. Patient outcomes were significantly improved for all parameters in both groups, except SLR which improved in the EXT group only (p= 0.043). CONCLUSIONS Applied treatments improved patient outcomes and were statistically significant in both groups, however, better outcomes were observed in the EXT group during follow-up. Mobilisation was a safe and effective procedure for the treatment of DDD.",2020,"Patient outcomes were significantly improved for all parameters in both groups, except SLR which improved in the EXT group only (p= 0.043). ","['young patients with different stages of degenerative disc disease', 'young patients with DDD, as diagnosed by MRI', 'patients suffering with different types of DDD', 'Thirty patients (24-35 years']",['EXT'],"['Numeric rating scale (NRS), Oswestry disability index (ODI), straight leg raise (SLR), passive lumbar extension (PLE) and lumbar range of motion (ROM', 'Mobilisation efficacy']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015306', 'cui_str': 'Multiple congenital exostosis'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0152992,"Patient outcomes were significantly improved for all parameters in both groups, except SLR which improved in the EXT group only (p= 0.043). ","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kuligowski', 'Affiliation': ''}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Dȩbiec-Ba K', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Skrzek', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181219'] 2160,32568196,"xSafety, Tolerability, and Pharmacokinetics of Crenezumab in Patients with Mild-To-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133 Weeks.","BACKGROUND Crenezumab is a fully humanized, monoclonal anti-amyloid-βimmunoglobulin G4 antibody. OBJECTIVE This Phase Ib study (NCT02353598) evaluated the safety, tolerability, and pharmacokinetics of crenezumabat doses of ≤120 mg/kg administered intravenously every 4 weeks (q4w). Immunogenicity and exploratory biomarkers were also evaluated. METHODS In this multicenter, double-blind study, participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive PET scan were randomized to receive crenezumab 30 or 45 mg/kg (Cohort 1, n = 21), 60 mg/kg (Cohort 2, n = 21), or 120 mg/kg (Cohort 3, n = 19) or corresponding placebo (n = 14) intravenously q4wfor 13 weeks. Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received crenezumab at the originally assigned dose level, except for Cohort 3 (crenezumab 60 mg/kg during OLE). Participants received regular brain MRIs to assess amyloid-related imaging abnormalities (ARIA). Results up to Week 133 are reported. RESULTS Approximately 94% of participants experienced ≥1 adverse event (AE). Most AEs were mild or moderate; 15.5% experienced a Grade ≥3 AE. No ARIA-edema/effusion (ARIA-E) events were observed. New ARIA-micro hemorrhages and hemosiderosis (ARIA-H) were reported in 4.9% (double-blind treatment period) and 9.9% (combined double-blind treatment and OLE periods) of participants. Steady-state trough concentrations of crenezumab were dose proportional and maintained for each dose level. CONCLUSION Crenezumab doses of ≤120 mg/kg intravenously q4w were well tolerated. The observed safety profile for ≤133 weeks of treatment in a mild-to-moderate AD population was similar to that seen in previous trials.",2020,No ARIA-edema/effusion (ARIA-E) events were observed.,"[""Patients with Mild-To-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133\xa0Weeks"", ""participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive PET scan"", 'Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received']","['regular brain MRIs', 'crenezumab', 'placebo']","['xSafety, Tolerability, and Pharmacokinetics of Crenezumab', 'New ARIA-micro hemorrhages and hemosiderosis (ARIA-H', 'tolerated', '≥1 adverse event (AE', 'safety, tolerability, and pharmacokinetics', 'Immunogenicity and exploratory biomarkers', 'No ARIA-edema/effusion (ARIA-E) events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3495884', 'cui_str': 'Amyloid related imaging abnormalities'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019114', 'cui_str': 'Hemosiderosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3267084', 'cui_str': 'Amyloid related imaging abnormality-oedema/effusion'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",71.0,0.439878,No ARIA-edema/effusion (ARIA-E) events were observed.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Honig', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Blondeau', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Quartino', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carrasco-Triguero', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bittner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Ostrowitzki', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200134'] 2161,32568198,Design and Rationale of the PACt-MD Randomized Clinical Trial: Prevention of Alzheimer's dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression.,"BACKGROUND By the time Alzheimer's disease and related disorders (ADRD) are diagnosed, efficacy of treatments is limited. Preventive interventions are urgently needed. OBJECTIVE To design a randomized controlled trial to assess a novel intervention that aims to prevent ADRD in high-risk groups. METHODS We report on the rationale and describe the design of a multisite randomized controlled trial that aims to prevent ADRD in older persons with: (1) mild cognitive impairment (MCI); (2) remitted major depressive disorder (MDD) without MCI; or (3) remitted MDD with MCI. RESULTS PACt-MD (Prevention of Alzheimer's dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression) is a trial that randomized 375 older participants with MCI, MDD, or MCI + MDD to cognitive remediation (CR) and transcranial direct current stimulation (tDCS) or sham-CR + sham-tDCS for 5 days/week for 8 weeks followed by boosters for 5 days/week once every 6 months until participants progress to MCI or ADRD, or the end of the study. Between boosters, participants are asked to train on CR daily. At baseline, end of 8 weeks, and yearly from baseline, participants undergo clinical, cognitive, and functional assessments. Primary aims are to compare the efficacy of CR + tDCS versus sham + sham in preventing: 1) long-term cognitive decline; and 2) incidence of ADRD or MCI. Secondary aim is to assess for cognitive improvement after the 8-week course. We will also explore the moderating and mediating effects of biomarkers collected from the participants. CONCLUSION PACt-MD is unique in combining brain stimulation and psychosocial intervention to prevent ADRD. PACt-MD is also a platform for studying multi-domain biomarkers that will advance our understanding of the relationships among MCI, MDD, and ADRD.",2020,"RESULTS PACt-MD (Prevention of Alzheimer's dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression) is a trial that randomized 375 older participants with MCI, MDD, or MCI + MDD to cognitive remediation (CR) and transcranial direct current stimulation (tDCS) or sham-CR + sham-tDCS for 5 days/week for 8 weeks followed by boosters for 5 days/week once every 6 months until participants progress to MCI or ADRD, or the end of the study.","['Mild cognitive impairment and Depression', '375 older participants with MCI, MDD, or MCI\u200a+\u200aMDD to cognitive remediation (CR) and', 'older persons with: (1) mild cognitive impairment (MCI); (2) remitted major depressive disorder (MDD) without MCI; or (3) remitted MDD with MCI', ""Alzheimer's dementia with""]","['Cognitive remediation plus transcranial direct current stimulation', 'CR\u200a+\u200atDCS versus sham\u200a+\u200asham', 'transcranial direct current stimulation (tDCS) or sham-CR\u200a+\u200asham-tDCS']",['cognitive improvement'],"[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],375.0,0.420069,"RESULTS PACt-MD (Prevention of Alzheimer's dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression) is a trial that randomized 375 older participants with MCI, MDD, or MCI + MDD to cognitive remediation (CR) and transcranial direct current stimulation (tDCS) or sham-CR + sham-tDCS for 5 days/week for 8 weeks followed by boosters for 5 days/week once every 6 months until participants progress to MCI or ADRD, or the end of the study.","[{'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Pollock', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, NY, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Corinne E', 'Initials': 'CE', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Flint', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Golas', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Graff-Guerrero', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Lourenco', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mah', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Ovaysikia', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto.'}, {'ForeName': 'Aristotle N', 'Initials': 'AN', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200141'] 2162,32568220,Laparoscopic Radical Left Pancreatectomy for Pancreatic Cancer: Surgical Strategy and Technique Video.,"Radical resection margins, resection of Gerota's (perirenal) fascia, and adequate lymph node dissection are crucial for an adequate oncological resection of left-sided pancreatic cancer. Several surgical techniques have been described in recent years, but few were specifically designed for minimally invasive approaches. This study describes and demonstrates a standardized and reproducible technique for an adequate oncological resection of pancreatic cancer: laparoscopic radical left pancreatectomy (LRLP). A 61-year-old woman presented with an incidental finding of a 3 cm mass in the left pancreas suspect for malignancy. Imaging did not reveal distant metastases, central vascular involvement, or morbid obesity, hence the patient was suitable for LRLP. This study describes the main steps of LRLP for pancreatic cancer. First, the lesser sac is opened by transecting the gastrocolic ligament. The splenic flexure of the colon is mobilized and the inferior border of the pancreas including Gerota's fascia is dissected down to the inferior border of the spleen. The pancreas is tunneled and hung, including Gerota's fascia with a vessel loop. At the pancreatic neck, a tunnel is created between the pancreas and the portal vein, likewise a vessel loop is passed. The pancreas is then transected using the graded compression technique with an endostapler. Both the splenic vein and artery are transected before completing the resection. The entire specimen is extracted in a retrieval bag via a small Pfannenstiel incision. Duration of the surgery was 210 min with 250 mL blood loss. Pathology revealed a R0-resection (>1 mm) of a well-to-moderately differentiated adenocarcinoma originating from an intraductal papillary mucinous neoplasm. A total of 15 tumor-negative lymph nodes were resected. This is a detailed description of LRLP for left-sided pancreatic cancer as is currently being used within the international, multicenter randomized DIPLOMA (Distal Pancreatectomy Minimally Invasive or Open for PDAC) trial.",2020,"Imaging did not reveal distant metastases, central vascular involvement, or morbid obesity, hence the patient was suitable for LRLP.","['Pancreatic Cancer', 'A 61-year-old woman presented with an incidental finding of a 3 cm mass in the left pancreas suspect for malignancy', 'pancreatic cancer']","['laparoscopic radical left pancreatectomy (LRLP', 'LRLP', 'Laparoscopic Radical Left Pancreatectomy', 'Surgical Strategy and Technique Video', ""Radical resection margins, resection of Gerota's (perirenal) fascia, and adequate lymph node dissection""]",[],"[{'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0743997', 'cui_str': 'Incidental Findings'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0400476', 'cui_str': '50-70% distal pancreatectomy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0227616', 'cui_str': 'Structure of fibrous capsule of kidney'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]",[],,0.0456372,"Imaging did not reveal distant metastases, central vascular involvement, or morbid obesity, hence the patient was suitable for LRLP.","[{'ForeName': 'Frederique L', 'Initials': 'FL', 'LastName': 'Vissers', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'Maurice J W', 'Initials': 'MJW', 'LastName': 'Zwart', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Balduzzi', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam; General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Korrel', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Lof', 'Affiliation': 'Department of Surgery, Southampton University Hospital NHS Foundation Trust.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abu Hilal', 'Affiliation': 'Department of Surgery, Southampton University Hospital NHS Foundation Trust.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam; m.g.besselink@amsterdamumc.nl.'}]",Journal of visualized experiments : JoVE,['10.3791/60332'] 2163,32568433,Alterations in Functional Connectivity During Different Phases of the Triggered Migraine Attack.,"OBJECTIVE To understand the changes in functional connectivity between brain areas of potential importance in migraine during different phases of the attack. BACKGROUND Migraine is a symptomatically heterogeneous disorder. Understanding the possible changes in brain function and, therefore, neurobiology during different phases of the migraine attack is important in developing disease biomarkers and advancing therapeutics. DESIGN Randomized, double-blind, placebo-controlled, multi-visit experimental study. METHODS Subjects aged 18-50 years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n = 53). Consented subjects had a 0.5 µg/kg/min nitroglycerin infusion or to placebo over 20 minutes during the period February 2015-July 2017. All subjects were exposed to a nitroglycerin infusion at least on 1 occasion at screening. For those subjects who consented to participate in imaging visits (n = 25), structural T1, T2 and FLAIR sequences and resting state blood oxygen level dependant contrast (rsBOLD) time series, using a multiecho EPI sequence, were conducted over 30-40 minutes at baseline and rsBOLD during premonitory symptoms and migraine headache on a 3T General Electric MR750 MRI scanner. For the placebo visit, the imaging was conducted at the same times following infusion in the absence of symptoms. RESULTS Montreal Neurological Institute (MNI) coordinates were used to characterize brain areas of connectivity change identified. Using repeated measures ANOVA models with time (visit number) and trigger substance (nitroglycerin/placebo) as factors, significant positive functional coupling was found between the thalami bilaterally and the right precuneus and cuneus regions during the nitroglycerin-triggered premonitory phase (T = 3.23, peak connectivity change at [-6, -68, 40] for left thalamus, P = .012 and [-4, -68, 40] for right thalamus, P = .019). The nitroglycerin-triggered premonitory phase was associated with a change in the direction of connectivity from positive to negative between the pons and the limbic lobe (T = 3.47, peak connectivity change at [2, 8, 50], P < .001). The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007). CONCLUSIONS Understanding the functional reorganization between subcortical and cortical brain areas in different phases of the migraine attack provides novel insights into the abnormal sensory processing and integration during migraine, as well as functional correlation with clinical symptoms displayed during each phase.",2020,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007). ","['Montreal Neurological Institute (MNI', 'Subjects aged 18-50\xa0years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n\xa0=\xa053']","['substance (nitroglycerin/placebo', 'nitroglycerin infusion or to placebo', 'nitroglycerin', 'placebo']","['Functional Connectivity', 'positive functional coupling', 'structural T1, T2 and FLAIR sequences and resting state blood oxygen level']","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.063712,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007). ","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Headache,['10.1111/head.13865'] 2164,32568447,Thematic analysis of acceptability and fidelity of engagement for behaviour change interventions: The Let's Move It intervention interview study.,"OBJECTIVES Intervention participants' responses to and engagement with interventions are a key intermediate step between interventions and intended outcomes. The aim of this study was to qualitatively investigate crucial aspects of engagement, namely acceptability (experienced cognitive and emotional responses to the intervention), receipt (comprehension of intervention content), and skill enactment (skill performance in target settings), within the Let's Move It, a multi-component school-based physical activity intervention. DESIGN A longitudinal qualitative study embedded in a cluster-randomized trial, with individual interviews of purposefully sampled intervention participants immediately post-intervention (n = 21) and at 14 months (n = 14). METHODS Semi-structured interviews were analysed using thematic analysis. Abductive coding process was taken to identify categories for themes. RESULTS The analysis resulted in 12 themes and 18 subthemes. Overall, participants reported perceived effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt). For example, findings indicated comprehension of the non-judgemental nature and choice-providing messages of the intervention underpinned by self-determination theory. Despite reporting understanding how and why to perform the skills, not using them was a highlighted theme (skill enactment), particularly for self-regulatory techniques such as planning. Friends' role as key self-motivation technique was a prevalent theme. In the within-individual analysis, three different engager types were identified: positive, ambivalent, and negative. CONCLUSION Identifying misunderstandings and difficulties in skill acquisition can help interpret main trial outcomes and inform further intervention optimization. This study provides an example of how to use thematic analysis to assess acceptability, receipt, and enactment in interventions.",2020,"Overall, participants reported perceived effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt).",[],[],"['acceptability and fidelity of engagement for behaviour change interventions', 'effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt']",[],[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",21.0,0.0465529,"Overall, participants reported perceived effectiveness of and affective attitude towards the intervention (acceptability) and understood the main messages and skills (receipt).","[{'ForeName': 'Minttu', 'Initials': 'M', 'LastName': 'Palsola', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Renko', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Kostamo', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Lorencatto', 'Affiliation': 'Centre for Behaviour Change, University College London, UK.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Hankonen', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Finland.'}]",British journal of health psychology,['10.1111/bjhp.12433'] 2165,32568452,"Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced vomiting in children: An open-label, randomized phase 3 trial.","BACKGROUND Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine and metoclopramide are two drugs recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV. PROCEDURE Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy were randomly assigned to the metoclopramide or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or metoclopramide for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms. RESULTS Eighty patients were analyzed (39 in the olanzapine arm and 41 in the metoclopramide arm). CR rates were significantly higher in the olanzapine arm compared with the metoclopramide arm for vomiting (72% vs 39%, P = 0.003) and nausea (59% vs 34%, P = 0.026). Seven patients in the metoclopramide arm crossed over to the olanzapine arm and none crossed over in the olanzapine arm (P < 0.001). The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01). Hyperglycemia and drowsiness were more commonly seen in the olanzapine arm. CONCLUSION Olanzapine is superior to metoclopramide for the treatment of breakthrough CIV in children. Drowsiness and hyperglycemia need to be monitored closely in children receiving olanzapine for breakthrough CIV.",2020,The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01).,"['Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy', 'Eighty patients were analyzed (39 in the olanzapine arm and 41 in the metoclopramide arm', 'patients receiving', 'children']","['olanzapine and metoclopramide', 'olanzapine', 'Olanzapine', 'metoclopramide', 'Olanzapine and metoclopramide', 'metoclopramide or olanzapine', 'olanzapine or metoclopramide']","['CR rates', 'Hyperglycemia and drowsiness', 'complete response (CR) rates', 'Drowsiness and hyperglycemia', 'mean nausea score', 'vomiting (CIV', 'CR rates for nausea and toxicities', 'vomiting', 'safety and efficacy', 'nausea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.0760245,The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01).,"[{'ForeName': 'Venkatraman', 'Initials': 'V', 'LastName': 'Radhakrishnan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Vishwajeeth', 'Initials': 'V', 'LastName': 'Pai', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Swaminathan', 'Initials': 'S', 'LastName': 'Rajaraman', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Trivadi', 'Initials': 'T', 'LastName': 'Ganesan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Manikandan', 'Initials': 'M', 'LastName': 'Dhanushkodi', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Jayachandran', 'Initials': 'J', 'LastName': 'Perumal Kalaiyarasi', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Arun Kumar', 'Initials': 'AK', 'LastName': 'Rajan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Gangothri', 'Initials': 'G', 'LastName': 'Selvarajan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Parathan', 'Initials': 'P', 'LastName': 'Karunakaran', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Tenali G', 'Initials': 'TG', 'LastName': 'Sagar', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}]",Pediatric blood & cancer,['10.1002/pbc.28532'] 2166,32568460,Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors.,"BACKGROUND Insomnia is common among adolescent and young adult (AYA) cancer survivors. Cognitive-behavioral therapy for insomnia (CBT-I) is considered the gold standard treatment. Standard CBT-I was designed for adults and not adapted to the unique medical, psychosocial, and developmental needs of AYA cancer survivors, which can exacerbate their insomnia. Further, the vast majority of cancer centers do not have a behavioral sleep medicine expert on staff. Our study objective was to examine the efficacy of an Internet-delivered CBT-I program that was tailored for AYA cancer survivors (NCT03279055). PROCEDURE Twenty-two AYA cancer survivors (mean age 20.4; range 14-25) with insomnia enrolled in an automated CBT-I program modified for AYA cancer survivors following stakeholder feedback. Participants were blood cancer (54.5%) and solid tumor (45.5%) survivors, an average of 9.7 years postdiagnosis. Sleep health, fatigue, and quality of life were assessed at baseline and at two follow up timepoints (8 and 16 weeks postbaseline). RESULTS Significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life were reported at both follow up timepoints. However, most participants (72.7%) did not complete all of the six study sessions, with a mean completion rate of 3.2 sessions. Participants who completed at least two sessions reported better sleep (insomnia severity index total score) than those who did not. CONCLUSIONS An Internet-delivered insomnia intervention adapted for AYA cancer survivors was efficacious. This has important implications for access to evidence-based clinical care for this growing population. Future efforts should study stepped care models of care and ways to improve treatment adherence.",2020,"RESULTS Significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life were reported at both follow up timepoints.","['Participants were blood cancer (54.5%) and solid tumor (45.5%) survivors, an average of 9.7\xa0years postdiagnosis', 'Twenty-two AYA cancer survivors (mean age 20.4; range 14-25) with insomnia enrolled in an automated CBT-I program modified for AYA cancer survivors following stakeholder feedback', 'adolescent and young adult (AYA) cancer survivors', 'adolescent and young adult cancer survivors']","['Internet-delivered insomnia intervention', 'Cognitive-behavioral therapy']","['sleep and quality of life', 'insomnia severity, daytime sleepiness, fatigue, and quality of life', 'Sleep health, fatigue, and quality of life', 'sleep (insomnia severity index total score']","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",25.0,0.04861,"RESULTS Significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life were reported at both follow up timepoints.","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Recklitis', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.""}]",Pediatric blood & cancer,['10.1002/pbc.28506'] 2167,32563598,Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial.,"BACKGROUND & AIMS Malnutrition frequently occurs and deteriorates in patients after surgery for gastric cancer, especially after hospital discharge, which has been consistently associated with negative outcomes. However, information regarding the impact of post-discharge nutritional interventions is poorly described. The aim of this study was thus to evaluate the impact of post-discharge oral nutritional supplements (ONS) with dietary advice compared with dietary advice alone on nutritional outcomes, including body mass index (BMI) and skeletal muscle index (SMI), sarcopenia prevalence, chemotherapy tolerance, the 90-day readmission rate, and quality of life in patients at nutritional risk after surgery for gastric cancer. METHODS Three hundred and fifty-three patients who underwent surgery for gastric cancer and were at nutritional risk (Nutritional Risk Screening 2002 [NRS 2002] score ≥3 points) in our institution were randomly assigned to receive either ONS with dietary advice or dietary advice alone (control) for 3 months after discharge. The primary endpoints were nutritional outcomes and sarcopenia prevalence; the secondary endpoints included chemotherapy tolerance, the 90-day readmission rate, and quality of life. RESULTS Three hundred and thirty-seven patients completed the study and were included in the analyses, consisting of 171 in the ONS group and 166 in the control group. The average daily intake of ONS in the intervention group was 370 mL. After 3 months of the intervention, the patients who received ONS and dietary advice had significantly less weight loss and higher BMI and SMI than those given dietary advice alone (P < 0.05). The incidence of sarcopenia was significantly lower in the ONS group than in the control group (P < 0.05). Similar number of patients in the two groups underwent postoperative chemotherapy, but the patients who received ONS and dietary advice had significantly less chemotherapy modifications, including delay, dose reduction, or termination (P < 0.05). The two groups had no significant differences in the 90-day readmission rate (P > 0.05). Regarding the quality of life, the patients who received ONS and dietary advice reported significantly less fatigue and appetite loss than those given dietary advice alone (P < 0.05), but the two groups showed no significant differences in the other outcomes (P > 0.05). CONCLUSIONS Post-discharge ONS with dietary advice in patients at nutritional risk after surgery for gastric cancer improved nutritional outcomes, skeletal muscle maintenance, chemotherapy tolerance and some quality of life variables. These findings strongly support the concept of the introduction of post-discharge ONS with dietary advice to this patient cohort.",2020,The incidence of sarcopenia was significantly lower in the ONS group than in the control group (P < 0.05).,"['patients at nutritional risk after surgery for gastric cancer', 'Three hundred and thirty-seven patients completed the study and were included in the analyses, consisting of 171 in the ONS group and 166 in the control group', 'Three hundred and fifty-three patients who underwent surgery for gastric cancer and were at nutritional risk (Nutritional Risk Screening 2002 [NRS 2002] score ≥3 points) in our institution', 'patients after surgery for gastric cancer']","['ONS and dietary advice', 'ONS with dietary advice or dietary advice alone (control', 'Post-discharge ONS with dietary advice', 'post-discharge oral nutritional supplements (ONS) with dietary advice compared with dietary advice alone', 'postoperative chemotherapy', 'dietary advice', 'ONS']","['quality of life', 'average daily intake of ONS', '90-day readmission rate', 'weight loss and higher BMI and SMI', 'nutritional outcomes and sarcopenia prevalence; the secondary endpoints included chemotherapy tolerance, the 90-day readmission rate, and quality of life', 'nutritional outcomes, skeletal muscle maintenance, chemotherapy tolerance and some quality of life variables', 'incidence of sarcopenia', 'nutritional outcomes, including body mass index (BMI) and skeletal muscle index (SMI), sarcopenia prevalence, chemotherapy tolerance, the 90-day readmission rate, and quality of life', 'chemotherapy modifications, including delay, dose reduction, or termination (P', 'fatigue and appetite loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}]",353.0,0.0344155,The incidence of sarcopenia was significantly lower in the ONS group than in the control group (P < 0.05).,"[{'ForeName': 'Qingyang', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shanjun', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qiulei', 'Initials': 'Q', 'LastName': 'Xi', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qiulin', 'Initials': 'Q', 'LastName': 'Zhuang', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guohao', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: prowugh@163.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.04.043'] 2168,32563599,Impact of oral nutritional supplements in post-discharge patients at nutritional risk following colorectal cancer surgery: A randomised clinical trial.,"BACKGROUND & AIMS Guidelines on clinical nutrition recommend the use of appropriate nutritional support therapy for surgical cancer patients at risk of malnutrition both during hospital care and following discharge from the hospital. However, previous studies regarding nutritional interventions have mainly focused on patients during their hospital stay; there is limited evidence supporting the recommendation of nutritional interventions for post-discharge patients after cancer surgery, particularly those who underwent gastrointestinal cancer surgery and at high risk of malnutrition. To clearly address this issue, we designed and conducted two independent studies on two different groups of post-discharge patients at nutritional risk after gastrointestinal cancer surgery. The present study aimed to assess the impact of oral nutritional supplements (ONS) in post-discharge patients at nutritional risk following colorectal cancer surgery. Meanwhile, the sister study on the use of ONS in post-discharge patients following gastric cancer surgery will be reported separately. METHODS Between January 2017 and June 2019, post-discharge patients following colorectal cancer surgery in our institution were randomised to receive either dietary advice alone (control group) or dietary advice in combination with ONS (ONS group) for three months if they were at nutritional risk based on the tool of Nutritional Risk Screening 2002. The primary endpoints were nutritional outcomes and sarcopenia prevalence. The secondary endpoints were 90-day readmission rate, chemotherapy tolerance, and quality of life (QoL). RESULTS Of the 232 eligible patients, 212 (107 in the control group and 105 in the ONS group) completed the trial. Their data were then analyzed. The mean ONS intake was 410 mL every day. By the three-month intervention, the skeletal muscle index in the ONS group was significantly higher than that in the control group (39.75 ± 5.83 vs 38.01 ± 6.18 cm 2 /m 2 , P = 0.037), but no significant differences between the two groups were noted in weight, weight loss, body mass index, serum albumin and hemoglobin (P > 0.05). In addition, the ONS group had a significantly lower sarcopenia prevalence (28.6% vs 42.1%, P = 0.040). No significant difference between the two groups was found in the 90-day readmission rate (P > 0.05). The number of patients undergoing postoperative chemotherapy in the two groups was similar, but chemotherapy modifications, such as delay, dose reduction, or termination, were significantly reduced in the ONS group (21.2% vs 36.8%, P=0.024). However, ONS had no significant effect on QoL (P > 0.05). CONCLUSIONS In post-discharge patients at nutritional risk following colorectal cancer surgery, the use of ONS may reduce skeletal muscle loss and sarcopenia prevalence, as well as improve chemotherapy tolerance, compared with dietary advice alone. These findings underline the importance of ONS treatment in post-discharge patients at nutritional risk following colorectal cancer surgery.",2020,No significant difference between the two groups was found in the 90-day readmission rate (P > 0.05).,"['post-discharge patients following gastric cancer surgery', 'surgical cancer patients at risk of malnutrition both during hospital care and following discharge from the hospital', 'Between January 2017 and June 2019, post-discharge patients following colorectal cancer surgery in our institution', 'two different groups of post-discharge patients at nutritional risk after gastrointestinal cancer surgery', '232 eligible patients, 212 (107 in the control group and 105 in the ONS group) completed the trial', 'post-discharge patients at nutritional risk following colorectal cancer surgery']","['oral nutritional supplements (ONS', 'oral nutritional supplements', 'dietary advice alone (control group) or dietary advice in combination with ONS (ONS group) for three months if they were at nutritional risk based on the tool of Nutritional Risk Screening 2002', 'ONS']","['QoL', 'nutritional outcomes and sarcopenia prevalence', '90-day readmission rate', '90-day readmission rate, chemotherapy tolerance, and quality of life (QoL', 'sarcopenia prevalence', 'weight, weight loss, body mass index, serum albumin and hemoglobin', 'number of patients undergoing postoperative chemotherapy', 'skeletal muscle index', 'mean ONS intake']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",232.0,0.0634898,No significant difference between the two groups was found in the 90-day readmission rate (P > 0.05).,"[{'ForeName': 'Shanjun', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qingyang', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qiulin', 'Initials': 'Q', 'LastName': 'Zhuang', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qiulei', 'Initials': 'Q', 'LastName': 'Xi', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jinou', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guohao', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery/Shanghai Clinical Nutrition Research Center, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: prowugh@163.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.038'] 2169,32563606,A phase 2 study of the bivalent VLP norovirus vaccine candidate in older adults; impact of MPL adjuvant or a second dose.,"INTRODUCTION Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL) in this population. METHODS In this phase II, double-blind, controlled trial 294 healthy adults, ≥ 60 years of age, were randomized (1:1:1:1) to four groups to receive one or two intramuscular immunizations 28 days apart, with 26 18-49 year-old controls who received one MPL-free dose. One-dose groups received placebo on Day 1. Vaccine formulations contained 15 μg GI.1 and 50 μg GII.4c VLP antigens and 500 μg Al(OH) 3 , with or without 15 μg MPL. We measured histo-blood group antigen blocking (HBGA) antibodies and ELISA Ig at Days 1, 8, 29, 57, 211 and 393, and avidity indices and cell-mediated immunity (CMI). Solicited local and systemic adverse events (AE) were assessed for 7 days and unsolicited AEs for 28 days after each injection. RESULTS After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393. GMTs were similar across age strata (18-49, 60-74, 75-84 and ≥ 85 years of age) and unaffected by a second vaccination or MPL. Total Ig showed similar responses. No clinically relevant differences or changes in avidity or CMI were observed between formulations. Both formulations were well tolerated with no vaccine-related SAEs, the most frequent AEs being mild injection site pain and fatigue. CONCLUSIONS Adults over 60 years of age displayed no safety concerns and had similar immune responses to the norovirus VLP vaccine candidate as younger adults, unaffected by increasing age, a second dose or inclusion of MPL. This data supports the further development of the MPL-free vaccine candidate for older adults.",2020,After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393.,"['294 healthy adults, ≥ 60\xa0years of age', 'older adults']","['intramuscular immunizations 28\xa0days apart, with 26 18-49\xa0year-old controls who received one MPL-free dose', 'bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL', 'placebo']","['Solicited local and systemic adverse events (AE', 'avidity indices and cell-mediated immunity (CMI', 'geometric mean titres (GMTs', 'avidity or CMI']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0066776', 'cui_str': 'monophosphoryl lipid A'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020966', 'cui_str': 'Cell-Mediated Immunity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",294.0,0.41082,After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Treanor', 'Affiliation': 'University of Rochester Medical Center, School of Medicine and Dentistry, Rochester NY, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Sherwood', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland. Electronic address: Jim.Sherwood@takeda.com.'}, {'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Cramer', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Le Cam Bouveret', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Baehner', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.06.011'] 2170,32563609,"Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial.","BACKGROUND To increase the global supply of affordable IPV vaccine, preferably using Sabin viruses to comply with GAPIII requirements, Takeda has assessed three dosages of a stand-alone sIPV. METHODS In this phase I/II study two cohorts of 40 adults and 60 toddlers, respectively, were initially assessed for safety after receiving high-dosage sIPV compared with placebo (adults) or Salk IPV (toddlers). A cohort of 240 infants was then enrolled and randomized (1:1:1:1) to receive low-, medium- or high-dosage sIPV, or a reference Salk IPV in a three-dose primary schedule at 6, 10 and 14 weeks of age. Parents completed safety diaries for 4 weeks after each dose, and immunogenicity was measured as neutralization antibody titers at baseline and four weeks after vaccination. RESULTS All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants. Infants displayed dosage-dependent immune responses to sIPV when assayed using Sabin strains, which were equivalent to the reference IPV in the high-dosage sIPV group for serotypes 1 and 2, but not for Sabin and Salk serotype 3. Seroconversion rates (SCR) of the low- and medium-dosage groups were significantly lower than the Salk IPV group for both Sabin and Salk serotypes 1 and type 2 (p < 0.05), with no significant differences for Salk or Sabin serotypes 3. Responses to sIPV, particularly to Sabin types 1 and 2, were higher in initially seronegative infants, indicating possible interference by maternally-derived antibodies. CONCLUSIONS A novel stand-alone Sabin-based IPV vaccine was well tolerated with an acceptable safety profile, but less immunogenic than reference Salk IPV at 6, 10 and 14 weeks of age for Salk serotypes 1 and 2, with apparent interference by maternal antibodies. Additional preclinical assessments will be made before any further clinical development.",2020,All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants.,"['240 infants', '40 adults and 60 toddlers', 'healthy infants']","['Salk IPV', 'experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations', 'placebo (adults) or Salk IPV (toddlers', 'low-, medium- or high-dosage sIPV, or a reference Salk IPV']","['safety diaries', 'neutralization antibody titers', 'Safety and immunogenicity', 'Seroconversion rates (SCR']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",240.0,0.09039,All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants.,"[{'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Cramer', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Jimeno', 'Affiliation': 'Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama, USA.'}, {'ForeName': 'Htay Htay', 'Initials': 'HH', 'LastName': 'Han', 'Affiliation': 'Takeda Vaccines, Inc., Cambridge, USA. Electronic address: htay-htay.han@takeda.com.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Takeda Vaccines, Inc., Cambridge, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hartmann', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sáez-Llorens', 'Affiliation': 'Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.05.081'] 2171,32573474,Evaluation of PRF Efficiency in the Treatment of Infrabony Defects.,"AIM The present study aimed to investigate the effectiveness of PRF in the treatment of infrabony defects in patients with chronic periodontitis by evaluating the clinical outcome through periodontal depth, clinical attachment level at the baseline, 6 and 9 months post operatively. MATERIAL AND METHODS Sixty infrabony defects with probing depth ≥ 5 mm were treated. The inclusion criterion was the necessity for surgical bilateral maxillary treatment. By using split-mouth study design, each patient had one side treated with conventional flap surgery and the other side with conventional flap surgery and PRF. Clinical parameters, such as probing depth (PD) and clinical attachment lost (CAL), were recorded in both groups at baseline, 6 and 9 months post operatively. RESULTS Positive effects for all clinical and radiographic parameters were evident in the group with PRF. Mean PD reduction demonstrated statistically significant greater results in the test group (4.00±1.07 mm) compared to the control one (4.83±0.99 mm), p = 0.003 after 9 months postoperatively. After 9 months, there were better results in the test group compared to the control group for CAL (5.60±1.61 mm, 6.20±1.58 mm), but statistically not significant. CONCLUSION Additional use of PRF in the conventional surgical treatment of infrabony defects demonstrated better parameters than the open flap debridement alone.",2020,"Mean PD reduction demonstrated statistically significant greater results in the test group (4.00±1.07 mm) compared to the control one (4.83±0.99 mm), p = 0.003 after 9 months postoperatively.","['patients with chronic periodontitis', 'Sixty infrabony defects with probing depth ≥ 5 mm were treated']","['PRF', 'conventional flap surgery and the other side with conventional flap surgery and PRF']","['probing depth (PD) and clinical attachment lost (CAL', 'Mean PD reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0569592,"Mean PD reduction demonstrated statistically significant greater results in the test group (4.00±1.07 mm) compared to the control one (4.83±0.99 mm), p = 0.003 after 9 months postoperatively.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Milutinovic', 'Affiliation': 'University Clinical Centre ""St. Pantelejmon"", University Ss. Cyril and Methodius, Faculty of Dentistry, Skopje, R.N. Macedonia.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Popovska', 'Affiliation': 'University Clinical Centre ""St. Pantelejmon"", University Ss. Cyril and Methodius, Faculty of Dentistry, Skopje, R.N. Macedonia.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Rusevska', 'Affiliation': 'University Clinical Centre ""St. Pantelejmon"", University Ss. Cyril and Methodius, Faculty of Dentistry, Skopje, R.N. Macedonia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Nacevski', 'Affiliation': 'University Clinical Centre ""St. Pantelejmon"", University Ss. Cyril and Methodius, Faculty of Dentistry, Skopje, R.N. Macedonia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Anastasovski', 'Affiliation': 'University Clinical Centre ""St. Pantelejmon"", University Ss. Cyril and Methodius, Faculty of Dentistry, Skopje, R.N. Macedonia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Ivanоvska-Stojanoska', 'Affiliation': 'University Clinical Centre ""St. Pantelejmon"", University Ss. Cyril and Methodius, Faculty of Dentistry, Skopje, R.N. Macedonia.'}]",Prilozi (Makedonska akademija na naukite i umetnostite. Oddelenie za medicinski nauki),['10.2478/prilozi-2020-0025'] 2172,32573523,Effects of Nordic walking on cardiovascular performance and quality of life in coronary artery disease.,"BACKGROUND Cardiometabolic effects of physical exercise depend on its intensity, duration, and type. Conventional cardiovascular rehabilitation (CCVR) programmes have significant advantages, but non-conventional activities such as Nordic walking (NW) may offer additional health benefits. AIM The aim of this study was to determine the feasibility and effectiveness of NW on cardiovascular performance and quality of life in patients with coronary artery disease (CAD) compared to a CCVR programme. DESIGN This was a pseudo-randomised, prospective, single-blinded, parallel-group trial. SETTING The study was conducted at a resort/spa type facility located in a mountainous natural environment, 650 metres above sea level. POPULATION 83 CAD patients were allocated to either a Nordic walking or a control group. METHODS The NW group (n=53; age 59.1±7.0 years) underwent a three-week outdoor exercise programme consisting of 40 minutes of walking four-times per week, whereas the controls performed traditional walking instead of NW. A patient's prescribed exercise intensity was according to exertion tolerance within 50-70% of peak oxygen consumption - VO2 max; rating of perceived exertion 'mild/moderate' (12 to 14 points) on the 0-20 Borg scale. Primary endpoint: cardiovascular and functional performance (EE-exercise ergometry; METs-metabolic equivalent of tasks; EF-ejection fraction; 6MWT-six-minute walking test). Secondary endpoint: quality of life (SF-36-Short Form Health Survey). Statistical analysis - Generalized Estimating Equations with Cohen's d Effect Size (ES). RESULTS NW led to higher cardiovascular performance compared to CCVR (Δ EE: +11.0% vs +3.2% - ES small; Δ METs: +9.8% vs +1.5% - ES medium) and better functional performance (Δ 6MWT: +8.3% vs +5.1% - ES small). No significant differences were detected in EF (p=0.240) and SF-36 (PCS, p=0.425; MCS, p=0.400). CONCLUSIONS A three-week NW training programme had clinically important effects, above and beyond CCVR, on cardiovascular and functional performance in CAD patients. CLINICAL REHABILITATION IMPACT Nordic walking is an accessible, safe, and effective low-threshold cardiac rehabilitation exercise training modality that seems to be particularly well-suited for people with limited functional and motivational capacities.",2020,"No significant differences were detected in EF (p=0.240) and SF-36 (PCS, p=0.425; MCS, p=0.400). ","['83 CAD patients', 'The NW group (n=53; age 59.1±7.0 years', 'coronary artery disease', 'patients with coronary artery disease (CAD', 'The study was conducted at a resort/spa type facility located in a mountainous natural environment, 650 metres above sea level']","['Nordic walking or a control group', 'outdoor exercise programme consisting of 40 minutes of walking four-times per week, whereas the controls performed traditional walking instead of NW', 'physical exercise', 'Conventional cardiovascular rehabilitation (CCVR) programmes', 'Nordic walking']","['quality of life (SF-36-Short Form Health Survey', 'functional performance', 'cardiovascular performance and quality of life', 'cardiovascular and functional performance', 'EF', 'cardiovascular and functional performance (EE-exercise ergometry; METs-metabolic equivalent of tasks; EF-ejection fraction; 6MWT-six-minute walking test', 'cardiovascular performance']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0700431', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C2983100', 'cui_str': 'Metabolic equivalent of task'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",83.0,0.153162,"No significant differences were detected in EF (p=0.240) and SF-36 (PCS, p=0.425; MCS, p=0.400). ","[{'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Nagyova', 'Affiliation': 'Department of Social and Behavioural Medicine, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic - iveta.nagyova@upjs.sk.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Jendrichovsky', 'Affiliation': 'Department of Social and Behavioural Medicine, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Rastislav', 'Initials': 'R', 'LastName': 'Kucinsky', 'Affiliation': 'Klamath Heart Clinic, Klamath Falls, OR, USA.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Lachytova', 'Affiliation': 'Department of Social and Behavioural Medicine, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Viliam', 'Initials': 'V', 'LastName': 'Rus', 'Affiliation': 'Cardiovascular Rehabilitation Centre, Vysne Ruzbachy, Slovak Republic.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06120-1'] 2173,32573537,[Elective surgery and oral carbohydrate loading].,"OBJECTIVE To evaluate the effect of preoperative oral carbohydrate loading on the course of perioperative period. MATERIAL AND METHODS We examined 93 patients who underwent elective abdominal and retroperitoneal surgery. In the main group ( n =47), carbohydrate drink was prescribed prior to surgery (33.5 g of carbohydrates and 4 g of hydrolyzed protein per 100 ml): 400 ml in the evening before surgery and 200 ml 2 hours before surgery. The control group included 46 patients who followed conventional fasting protocol recommended by the ASA (solid food no later than 6 hours before surgery, intake of clear fluids no later than 2 hours before surgery). Surgical interventions and anesthetic management were similar in both groups. RESULTS There were no differences in perioperative glycemia between both groups. The main group was characterized by less intraoperative infusion volume and more stable hemodynamic parameters, the number of patients with organ dysfunction and complications was significantly lower. Postoperative nausea and vomiting and general weakness were less significant in the main group while subjective assessment of patient's satisfaction with postoperative period was higher. CONCLUSION Preoperative carbohydrate loading does not affect perioperative glycemia, reduces intraoperative infusion volume, the number of patients with organ dysfunction and complications, postoperative nausea and vomiting, ensures more stable intraoperative hemodynamics and more comfortable subjective perception of early postoperative period.",2020,"CONCLUSION Preoperative carbohydrate loading does not affect perioperative glycemia, reduces intraoperative infusion volume, the number of patients with organ dysfunction and complications, postoperative nausea and vomiting, ensures more stable intraoperative hemodynamics and more comfortable subjective perception of early postoperative period.","['93 patients who underwent elective abdominal and retroperitoneal surgery', '46 patients who followed conventional fasting protocol recommended by the ASA (solid food no later than 6 hours before surgery, intake of clear fluids no later than 2 hours before surgery']","['preoperative oral carbohydrate loading', 'Elective surgery and oral carbohydrate loading', 'carbohydrate drink was prescribed prior to surgery (33.5 g of carbohydrates and 4 g of hydrolyzed protein per 100 ml']","['intraoperative infusion volume and more stable hemodynamic parameters, the number of patients with organ dysfunction and complications', 'Postoperative nausea and vomiting and general weakness', 'perioperative glycemia', 'intraoperative infusion volume, the number of patients with organ dysfunction and complications, postoperative nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0453855', 'cui_str': 'Solid food'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453847', 'cui_str': 'Clear fluid'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4277655', 'cui_str': 'Carbohydrate Loading Diet'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",,0.0625074,"CONCLUSION Preoperative carbohydrate loading does not affect perioperative glycemia, reduces intraoperative infusion volume, the number of patients with organ dysfunction and complications, postoperative nausea and vomiting, ensures more stable intraoperative hemodynamics and more comfortable subjective perception of early postoperative period.","[{'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Pasechnik', 'Affiliation': 'Central State Medical Academy, Moscow, Russia.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Smeshnoy', 'Affiliation': 'Central State Medical Academy, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Timashkov', 'Affiliation': 'Clinical Hospital of the Presidential Administration, Moscow, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Onegin', 'Affiliation': 'Clinical Hospital of the Presidential Administration, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Cheparnov', 'Affiliation': 'Clinical Hospital of the Presidential Administration, Moscow, Russia.'}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Skobelev', 'Affiliation': 'Central State Medical Academy, Moscow, Russia.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Markelov', 'Affiliation': 'Central State Medical Academy, Moscow, Russia.'}]",Khirurgiia,['10.17116/hirurgia202006182'] 2174,32573670,Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial.,"Importance Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain. Objective To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery. Design, Setting, and Participants The Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018. Interventions The dexamethasone group (n = 194) received 1 mg/kg of dexamethasone; the control group (n = 200) received an equivolume of 0.9% sodium chloride intravenously after anesthesia induction. Main Outcomes and Measures The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization. Results All of the 394 patients randomized (median age, 6 months; 47.2% boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95% CI, -0.8% to 15.3%; hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P = .20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group. Conclusions and Relevance Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference. Trial Registration ClinicalTrials.gov Identifier: NCT02615262.",2020,"The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery.","['394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018', 'Infants Undergoing Cardiac Surgery', 'infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of', '394 patients randomized (median age, 6 months; 47.2% boys) completed the trial']","['dexamethasone', 'equivolume of 0.9% sodium chloride intravenously after anesthesia induction', 'Intraoperative Dexamethasone', 'placebo']","['major complications and mortality', 'individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization', 'Major Complications and Mortality', 'composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications', 'Infections']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",394.0,0.579415,"The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery.","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Lomivorotov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Kornilov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Boboshko', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Shmyrev', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Soynov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Voytov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Polyanskih', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Strunin', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bogachev-Prokophiev', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Caetano', 'Initials': 'C', 'LastName': 'Nigro Neto', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Gretel', 'Initials': 'G', 'LastName': 'Oliveira Nicolau', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Saurith Izquierdo', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Vinícius', 'Initials': 'V', 'LastName': 'Nogueira Nascimento', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': ""Shanghai Jiaotong University School of Medicine, Shanghai Children's Medical Center, Shanghai Shi, China.""}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Renjie', 'Affiliation': ""Shanghai Jiaotong University School of Medicine, Shanghai Children's Medical Center, Shanghai Shi, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Haibo', 'Affiliation': ""Shanghai Jiaotong University School of Medicine, Shanghai Children's Medical Center, Shanghai Shi, China.""}, {'ForeName': 'Vladlen', 'Initials': 'V', 'LastName': 'Bazylev', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Evdokimov', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Shahrijar', 'Initials': 'S', 'LastName': 'Sulejmanov', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Aleksei', 'Initials': 'A', 'LastName': 'Chernogrivov', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Ponomarev', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}]",JAMA,['10.1001/jama.2020.8133'] 2175,32573795,Evaluation of the Pharmacokinetic Interaction of Ubrogepant Coadministered With Sumatriptan and of the Safety of Ubrogepant With Triptans.,"OBJECTIVE To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine. BACKGROUND Calcitonin gene-related peptide is a potent vasodilatory neurotransmitter believed to play a key role in the pathophysiology of migraine. Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine. Sumatriptan is a serotonin receptor agonist and the most commonly used triptan for the acute treatment of migraine. Ubrogepant could be prescribed with triptans. DESIGN The Phase 1 study was a single-center, open-label, randomized, 3-way crossover, single-dose, pharmacokinetic interaction study, where participants received each of 3 oral treatments with a 7-day washout period between treatments: single dose of ubrogepant 100 mg, single dose of sumatriptan 100 mg, and ubrogepant 100 mg plus sumatriptan 100 mg. Pharmacokinetic parameters were calculated using a model-independent approach. The ACHIEVE I and II trials were 2 multicenter, single-attack, randomized, Phase 3 trials in adults with a history of migraine with or without aura. Participants had the option to take a second dose of study medication or rescue medication to treat a nonresponding migraine or a migraine recurrence from 2 to 48 hours after the initial dose of study medication. Rescue medication options included acetaminophen, nonsteroidal anti-inflammatory drugs, opioids, anti-emetics, or triptans. Treatment-emergent adverse events were evaluated up to 30 days after the last dose in the Phase 1 and Phase 3 studies. RESULTS Ubrogepant median time to maximum plasma concentration was delayed (3 hours [range: 1-5 hours] vs 1.5 hours [range: 1-4 hours]), mean maximum plasma concentration was reduced by 24% (coefficient of variation: 37.4%) when ubrogepant was coadministered with sumatriptan (n = 29) compared with ubrogepant administered alone (N = 30). No significant effect was observed on the area under the plasma concentration-time curve of ubrogepant. Sumatriptan area under the curve and maximum plasma concentration showed no significant change when sumatriptan was coadministered with ubrogepant (n = 29), but the sumatriptan time to maximum plasma concentration was delayed (1 hour [range: 0.5-5 hours] vs 3 hours [range: 0.5-6 hours]. No treatment-emergent adverse events were reported with the coadministration of ubrogepant 100 mg and sumatriptan 100 mg in the Phase 1 study. The pooled safety data from ACHIEVE trials (N = 1938) showed similar rates of treatment-related treatment-emergent adverse events between participants who took ubrogepant alone and participants who took ubrogepant and a triptan as a rescue medication (14.9% [53/355] vs 12.8% [5/39] in the ubrogepant 100 mg treatment group, respectively). CONCLUSIONS Although there were slight alterations in ubrogepant pharmacokinetic parameters when coadministered with sumatriptan, such changes are expected to have minimal clinical relevance, especially because no changes were seen in sumatriptan area under the curve and maximum plasma concentration when coadministered with ubrogepant. Coadministration of ubrogepant with sumatriptan was well tolerated in healthy participants in the Phase 1 study, and coadministration of ubrogepant with triptans was well tolerated in participants with migraine in the Phase 3 trials. No new safety concerns for ubrogepant were identified across all trials.",2020,Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine.,"['Participants had the option to take a second dose of study medication or rescue medication to treat a nonresponding migraine or a migraine recurrence from 2 to 48\xa0hours after the initial dose of study medication', 'participants with migraine', 'adults with a history of migraine with or without aura', 'participants with migraine in the Phase 3 trials', 'healthy participants']","['Ubrogepant Coadministered With Sumatriptan', 'ubrogepant 100\xa0mg, single dose of sumatriptan 100\xa0mg, and ubrogepant 100\xa0mg plus sumatriptan 100\xa0mg', 'sumatriptan', 'Sumatriptan']","['Sumatriptan area under the curve and maximum plasma concentration', 'mean maximum plasma concentration', 'acetaminophen, nonsteroidal anti-inflammatory drugs, opioids, anti-emetics, or triptans', 'Ubrogepant median time to maximum plasma concentration', 'sumatriptan time to maximum plasma concentration', 'rates of treatment-related treatment-emergent adverse events', 'safety and tolerability', 'area under the plasma concentration-time curve of ubrogepant', 'Pharmacokinetic parameters']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1126059', 'cui_str': 'Sumatriptan 100 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0162754', 'cui_str': 'Serotonin 5-HT1 receptor agonist'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0313899,Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine.,"[{'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McGeeney', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Periclou', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}]",Headache,['10.1111/head.13862'] 2176,32573801,Threat vs control: Potentiation of the trigeminal blink reflex by threat proximity is overruled by self-stimulation.,"The magnitude of the defensive blink reflex is modulated by continuous assessment of its protective value. Here, we studied whether the trigeminal blink reflex (TBR) is modulated by a potentially offensive object close to the face, and, if so, whether self-stimulation or observation of the act of stimulus triggering counteracts such modulation. In all, 26 healthy volunteers participated in various experimental conditions. At baseline, an experimenter triggered supraorbital nerve stimuli remotely, unseen by the participants; in experimental conditions, the experimenter held a stimulation probe close to the participant's face but triggered the stimuli either remotely, ""surprising"" participants (S 1 ), or directly on the probe, observed by participants (S 2 ). In other conditions, participants triggered stimuli themselves on the probe held next to their body (S 3 ) or held in front of their face (S 4 ). The latter condition was repeated similarly, but pressing the button only randomly generated electrical stimuli (S5, ""Russian roulette""). The size of the R2 component of the TBR (TBR-R2) was the main outcome measure. Compared to baseline, TBR-R2 area was significantly larger in S 1 when the ""threatening"" probe was close to the face and the participant had no control over stimulation. Conversely, TBR-R2 was suppressed when participants either saw the action of triggering, thus being aware (S 2 ), or had full initiative over stimulation (S 3 , S 4 ). Random self-generated stimuli (S 5 ) inhibited TBR-R2, but to a lesser extent than S 3 and S 4. Perceived threat close to the face facilitates TBR-R2, but knowledge about impending stimulation or self-agency overrules this effect.",2020,"Perceived threat close to the face facilitates TBR-R2, but knowledge about impending stimulation or self-agency overrules this effect.",['26 healthy volunteers participated in various experimental conditions'],['trigeminal blink reflex (TBR'],"['TBR-R2', 'TBR-R2 area', 'size of the R2 component of the TBR (TBR-R2']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0596003', 'cui_str': 'Blink reflex'}]","[{'cui': 'C0596003', 'cui_str': 'Blink reflex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",26.0,0.0147525,"Perceived threat close to the face facilitates TBR-R2, but knowledge about impending stimulation or self-agency overrules this effect.","[{'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Versace', 'Affiliation': 'Department of Neurorehabilitation, Hospital of Vipiteno/Sterzing, Vipiteno/Sterzing, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Campostrini', 'Affiliation': 'Department of Neurorehabilitation, Hospital of Vipiteno/Sterzing, Vipiteno/Sterzing, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Sebastianelli', 'Affiliation': 'Department of Neurorehabilitation, Hospital of Vipiteno/Sterzing, Vipiteno/Sterzing, Italy.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Saltuari', 'Affiliation': 'Research Unit for Neurorehabilitation of South Tyrol, Bolzano/Bozen, Italy.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls-Solé', 'Affiliation': ""IDIBAPS (Institut d'Investigació August Pi i Sunyer), Facultat de Medicina, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Kofler', 'Affiliation': 'Department of Neurology, Hochzirl Hospital, Zirl, Austria.'}]",Psychophysiology,['10.1111/psyp.13626'] 2177,32573910,Early changes in bone turnover and inflammatory biomarkers and clinically significant bone mineral density loss over 48 weeks among HIV-infected patients with virological failure of a standard first-line antiretroviral therapy regimen in the SECOND-LINE study.,"OBJECTIVES We assessed whether changes at week 12 in markers of bone turnover, inflammation, and immune activation were associated with clinically important (≥ 5%) bone mineral density (BMD) loss from baseline to week 48 at the proximal femur (hip) and lumbar spine in the SECOND-LINE study. METHODS We measured concentrations of procollagen type 1 pro-peptide (P1NP), carboxyl-terminal collagen crosslinks (CTX), high-sensitivity C-reactive protein (hs-CRP), D-dimer, interleukin (IL)-6, tumor necrosis factor (TNF), neopterin, and soluble CD14 and 163 at weeks 0, 12, and 48 in 123 SECOND-LINE dual-energy X-ray absorptiometry (DXA) substudy participants. Linear regression was used to compare changes in biomarkers. Predictors of ≥ 5% BMD loss were examined using multivariable regression. RESULTS The mean age was 38 years, the mean CD4 T-cell count was 252 cells/µL and the mean viral load was 4.2 log HIV-1 RNA copies/mL; 56% of participants were female and 47% were randomized to receive a nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI]-based regimen [91% (53/58) were randomized to receive a tenofovir disoproxil fumarate (TDF)-containing regimen]. Over 48 weeks, 71% in the N(t)RTI arm experienced ≥ 5% hip BMD loss vs. 29% in the raltegravir arm (P = 0.001). Week 12 changes in P1NP and CTX were significantly greater among patients experiencing ≥ 5% hip BMD loss, patients randomized to N(t)RTI, and male patients. Predictors of ≥ 5% hip BMD loss at week 48 were P1NP increase [odds ratio (OR) 5.0; 95% confidence interval (CI) 1.1-27; P < 0.043]; N(t)RTI randomization (OR 6.7; 95% CI 2.0-27.1; P < 0.003), being African, higher baseline CD4 T cell count , and smoking. CONCLUSIONS In a diverse cohort of viraemic HIV-infected patients, switching to second-line antiretroviral therapy (ART) was associated with clinically significant BMD loss, which was correlated with an early increase in P1NP. Measurement of P1NP may facilitate timely interventions to reduce rapid BMD loss among at-risk patients.",2020,"Week 12 changes in P1NP and CTX were significantly greater among patients experiencing ≥ 5% hip BMD loss, patients randomized to N(t)RTI, and male patients.",['participants were female and 47'],"['tenofovir disoproxil fumarate (TDF)-containing regimen', 'nucleos(t)ide reverse transcriptase inhibitor']","['rapid BMD loss', 'mean CD4 T-cell count', 'BMD loss', 'bone mineral density loss', 'bone mineral density (BMD) loss', 'hip BMD loss', 'bone turnover and inflammatory biomarkers', 'baseline CD4 T cell count , and smoking', 'P1NP and CTX', 'concentrations of procollagen type 1 pro-peptide (P1NP), carboxyl-terminal collagen crosslinks (CTX), high-sensitivity C-reactive protein (hs-CRP), D-dimer, interleukin (IL)-6, tumor necrosis factor (TNF), neopterin, and soluble CD14', 'bone turnover, inflammation, and immune activation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.153457,"Week 12 changes in P1NP and CTX were significantly greater among patients experiencing ≥ 5% hip BMD loss, patients randomized to N(t)RTI, and male patients.","[{'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Mwasakifwa', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Amin', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'White', 'Affiliation': 'Department of Endocrinology, Prince of Wales Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Center', 'Affiliation': 'The Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kelleher', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boyd', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}]",HIV medicine,['10.1111/hiv.12882'] 2178,32573912,Effects of water- and land-based exercises on quality of life and physical aspects in women with fibromyalgia: A randomized clinical trial.,"INTRODUCTION Fibromyalgia (FM) is consistently associated with fatigue, sleep disturbances, morning stiffness, and anxiety and depression, affecting physical capacities and skills and thereby reducing quality of life. The aim of this study was to compare the effects of water-based and land-based therapies as an adjuvant treatment for women with FM in relation to quality of life and physical aspects. METHODS FM women were randomized into a water-based exercise group (WG) and land-based exercise group (LG). The interventions were conducted for 8 weeks, three times a week, and each therapy session had a 60-min duration. Evaluations were performed before and after intervention using the Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score. RESULTS Both interventions produced significantly positive clinical effects in most aspects evaluated. However, only WG obtained significant improvements for the variables functional capacity, number of TPs, and flexibility. CONCLUSIONS The findings suggest that water-based exercise is effective as an adjuvant FM treatment, including FM-related physical and psychological health aspects.",2020,"Evaluations were performed before and after intervention using the Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score. ","['women with fibromyalgia', 'women with FM in relation to quality of life and physical aspects', 'FM women']","['water-based exercise group (WG) and land-based exercise group (LG', 'water-based and land-based therapies', 'water- and land-based exercises']","['Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score', 'variables functional capacity, number of TPs, and flexibility', 'quality of life and physical aspects', 'positive clinical effects']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0205170', 'cui_str': 'Good'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0554292,"Evaluations were performed before and after intervention using the Fibromyalgia Impact Questionnaire, the Visual Analogue Scale, the number of tender points (TPs), and the Wells bench sit and reach test score. ","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Britto', 'Affiliation': 'School of Medicine, Federal University of Maranhão, Pinheiro, Brazil.'}, {'ForeName': 'Vandilson', 'Initials': 'V', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Morphology, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Alcione M', 'Initials': 'AM', 'LastName': 'Dos Santos', 'Affiliation': 'Collective Health Graduate Program, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rizzini', 'Affiliation': 'Collective Health Graduate Program, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Britto', 'Affiliation': 'Physiotherapy Service, Club Sante, São Luís, Brazil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Britto', 'Affiliation': 'Physiotherapy Service, Club Sante, São Luís, Brazil.'}, {'ForeName': 'João B S', 'Initials': 'JBS', 'LastName': 'Garcia', 'Affiliation': 'Health Science Graduate Program, Federal University of Maranhão, São Luís, Brazil.'}]",Musculoskeletal care,['10.1002/msc.1481'] 2179,32568732,"Ginger (Zingiber officinale) and turmeric (Curcuma longa L.) supplementation effects on quality of life, body composition, bone mineral density and osteoporosis related biomarkers and micro-RNAs in women with postmenopausal osteoporosis: a study protocol for a randomized controlled clinical trial.","Objectives Phytomedicine is widely suggested for the prevention of chronic disease, but evidence for a favorable effect on bone health is lacking. The present study will investigate the Zingiber officinale (ZO) and Curcuma longa L. (CL) supplementation effects on quality of life, body composition, bone mineral density (BMD) and osteoporosis related biomarkers and micro-RNAs in women with postmenopausal osteoporosis (PMO). Methods This study protocol is designed as prospective triple-blind randomized controlled trial. One hundred and 20 patients with PMO will be enrolled in a 4 month, prospective, triple-blind, placebo-controlled trial and randomly assigned to four groups: ZO (500 mg b.i.d.) + CL (500 mg b.i.d.) (ZO + CL); ZO (500 mg b.i.d.) + placebo CL (b.i.d.) (ZO + P); placebo ZO (b.i.d.) + CL (500 mg b.i.d.) (CL + P); and placebo ZO (b.i.d.) + placebo CL (b.i.d.) (P + P). Quality of life, body composition and BMD will be defined as the primary endpoints and osteoporosis related serum biomarkers and circulating micro-RNAs will be defined as the secondary endpoints. The ANCOVA statistical method will be used to investigate the effect of the interventional variables on the response variable. Conclusion To our knowledge, this trial is the first clinical study exploring the effect of Ginger and turmeric on quality of life, body composition, BMD and osteoporosis related biomarkers and micro-RNAs in women with PMO. The findings of this trial could be the basis for the development of harmless and inexpensive preventive and therapeutic approaches for PMO.",2020,The findings of this trial could be the basis for the development of harmless and inexpensive preventive and therapeutic approaches for PMO.,"['women with postmenopausal osteoporosis', 'women with PMO', 'One hundred and\xa020 patients with PMO', 'women with postmenopausal osteoporosis (PMO']","['\xa0CL', 'ZO', 'ZO\xa0+\xa0CL', 'Ginger (Zingiber officinale) and turmeric (Curcuma longa L.) supplementation', 'ZO\xa0+\xa0P); placebo ZO (b.i.d.)\xa0+\xa0CL', 'placebo ZO (b.i.d', '\xa0placebo CL', 'Ginger and turmeric', 'Zingiber officinale (ZO) and Curcuma longa L. (CL) supplementation', 'placebo']","['quality of life, body composition, BMD and osteoporosis related biomarkers and micro-RNAs', 'quality of life, body composition, bone mineral density (BMD) and osteoporosis related biomarkers and micro-RNAs', 'quality of life, body composition, bone mineral density and osteoporosis related biomarkers and micro-RNAs', 'Quality of life, body composition and BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}]",20.0,0.191731,The findings of this trial could be the basis for the development of harmless and inexpensive preventive and therapeutic approaches for PMO.,"[{'ForeName': 'Dawood', 'Initials': 'D', 'LastName': 'Aghamohammadi', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Islamic Republic of Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Dolatkhah', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Emam Reza Hospital, Tabriz University of Medical Sciences, Golgasht, Azadi Ave, Tabriz, Islamic Republic of Iran.'}, {'ForeName': 'Seyed Kazem', 'Initials': 'SK', 'LastName': 'Shakouri', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Islamic Republic of Iran.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Hermann', 'Affiliation': 'Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Eslamian', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Islamic Republic of Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2020-0017'] 2180,32568808,A Randomized Controlled Trial of a Physical Activity Intervention for Self-management of Fatigue in Adolescents and Young Adults With Cancer.,"BACKGROUND Fatigue remains a persistent and troubling symptom for adolescents and young adults (AYAs) with cancer. Physical activity (PA) is recommended as a strategy for self-management of fatigue. OBJECTIVE The aim of the study was to examine a PA intervention to improve the self-management of fatigue in AYAs during chemotherapy. METHODS This randomized controlled trial enrolled AYAs (18-39 years) receiving chemotherapy. Adolescents and young adults in the intervention group received a 12-week PA intervention integrated into 5 clinic visits that included education, PA tracking, and collaboration. Physical activity was measured with an accelerometer, and participants completed measures of fatigue severity, self-efficacy for PA, and self-regulation at baseline and end of study. RESULTS Forty-four AYAs completed the study. At baseline, AYAs averaged 4290 (SD, 2423) steps/day and 14.4 (SD, 20.6) minutes/day of moderate- to vigorous-intensity PA; their average Patient-Reported Outcomes Measurement Information System fatigue score was 55.0 (SD, 9.2). At end of study, there were no significant differences between groups in fatigue, self-efficacy, self-regulation, or PA, but trends in the desired direction were observed for each of the variables in the intervention group. CONCLUSION During chemotherapy, AYAs had variable levels of PA and engaged in mostly light-intensity PA. Their average fatigue level was slightly worse than a national comparison group. IMPLICATIONS FOR PRACTICE Tailored interventions are needed to promote PA in AYAs as a self-management strategy for fatigue. Enhancing self-efficacy and self-regulation may be important approaches to promote PA.",2020,"At end of study, there were no significant differences between groups in fatigue, self-efficacy, self-regulation, or PA, but trends in the desired direction were observed for each of the variables in the intervention group. ","['Adolescents and Young Adults With Cancer', 'Forty-four AYAs completed the study', 'adolescents and young adults (AYAs) with cancer', 'Adolescents and young adults']","['PA intervention', 'PA intervention integrated into 5 clinic visits that included education, PA tracking, and collaboration', 'Physical Activity Intervention', 'Physical activity (PA', 'chemotherapy']","['fatigue, self-efficacy, self-regulation, or PA', 'Physical activity', 'Outcomes Measurement Information System fatigue score', 'average fatigue level', 'fatigue severity, self-efficacy for PA, and self-regulation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0738748,"At end of study, there were no significant differences between groups in fatigue, self-efficacy, self-regulation, or PA, but trends in the desired direction were observed for each of the variables in the intervention group. ","[{'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Erickson', 'Affiliation': 'Author Affiliations: College of Nursing (Drs Erickson and Ke) and College of Health Sciences and Department of Kinesiology (Mr Tokarek and Dr Swartz), University of Wisconsin-Milwaukee, Milwaukee, Wisconsin.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Tokarek', 'Affiliation': ''}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Ke', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Swartz', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000834'] 2181,32568810,Evaluation of Evidence-Based Guidelines for Fever Management in Critically Ill Adult Patients With Brain Injury.,"PURPOSE The aim of this study was to evaluate the effectiveness of evidence-based guidelines for fever management of critically ill adult patients with brain injury. METHODS We used a pretest-posttest design with 48 patients 19 years or older admitted to an intensive care unit after surgery for brain injury. We applied evidence-based guidelines only to an experimental group of 24 patients and compared with 24 control patients who did not receive evidence-based guidelines. Experimental and control groups were matched 1:1 using the Acute Physiology and Chronic Health Evaluation II score. Data included the proportion of patients with reduced fever and time to normalized temperature. RESULTS The proportion of patients whose temperature fell to normal after fever was 4.5 times higher in the experimental group than in the control group. The time it took the patients' highest fever to fall to normal during their intensive care unit stay was 4.84 times faster in the experimental group than in the control group (hazard ratio, 4.84; 95% confidence interval, 1.79-13.11; P = .002). CONCLUSION Evidence-based guidelines for fever management in patients with a brain injury can be used in nursing practice with rapid response, improving healthcare efficiency and contributing to better outcomes for critically ill patients.",2020,The proportion of patients whose temperature fell to normal after fever was 4.5 times higher in the experimental group than in the control group.,"['critically ill patients', '24 patients and compared with 24 control patients who did not receive evidence-based guidelines', 'critically ill adult patients with brain injury', 'patients with a brain injury', '48 patients 19 years or older admitted to an intensive care unit after surgery for brain injury', 'Critically Ill Adult Patients With Brain Injury']",[],['temperature fell to normal after fever'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",[],"[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0836794,The proportion of patients whose temperature fell to normal after fever was 4.5 times higher in the experimental group than in the control group.,"[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Jung Min Lee, RN, is Staff Nurse, Neurosurgery Intensive Care Unit, Department of Nursing, Samsung Medical Center; and Doctoral Candidate, College of Nursing, The Catholic University of Korea, Seoul, South Korea. Hye Jeong Kim, is Unit Manager, Department of Nursing, Samsung Medical Center, Seoul, South Korea. Do Yeon Kwon, RN, is Staff Nurse, Neurosurgery Intensive Care Unit, Department of Nursing, Samsung Medical Center, Seoul, South Korea. Ja Young Shin, RN, is Staff Nurse, Neurosurgery Intensive Care Unit, Department of Nursing, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ju Ryoung', 'Initials': 'JR', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Hye Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Do Yeon', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Ja Young', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000524'] 2182,32568845,Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial.,"BACKGROUND The effect of anesthetic drugs on cancer outcomes remains unclear. This trial aimed to assess postoperative circulating tumor cell counts-an independent prognostic factor for breast cancer-to determine how anesthesia may indirectly affect prognosis. It was hypothesized that patients receiving sevoflurane would have higher postoperative tumor cell counts. METHODS The parallel, randomized controlled trial was conducted in two centers in Switzerland. Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible. The patients were randomly assigned to either sevoflurane or propofol anesthesia. The patients and outcome assessors were blinded. The primary outcome was circulating tumor cell counts over time, assessed at three time points postoperatively (0, 48, and 72 h) by the CellSearch assay. Secondary outcomes included maximal circulating tumor cells value, positivity (cutoff: at least 1 and at least 5 tumor cells/7.5 ml blood), and the association between natural killer cell activity and tumor cell counts. This trial was registered with ClinicalTrials.gov (NCT02005770). RESULTS Between March 2014 and April 2018, 210 participants were enrolled, assigned to sevoflurane (n = 107) or propofol (n = 103) anesthesia, and eventually included in the analysis. Anesthesia type did not affect circulating tumor cell counts over time (median circulating tumor cell count [interquartile range]; for propofol: 1 [0 to 4] at 0 h, 1 [0 to 2] at 48 h, and 0 [0 to 1] at 72 h; and for sevoflurane: 1 [0 to 4] at 0 h, 0 [0 to 2] at 48 h, and 1 [0 to 2] at 72 h; rate ratio, 1.27 [95% CI, 0.95 to 1.71]; P = 0.103) or positivity. In one secondary analysis, administrating sevoflurane led to a significant increase in maximal tumor cell counts postoperatively. There was no association between natural killer cell activity and circulating tumor cell counts. CONCLUSIONS In this randomized controlled trial investigating the effect of anesthesia on an independent prognostic factor for breast cancer, there was no difference between sevoflurane and propofol with respect to circulating tumor cell counts over time. : WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Anesthesia may contribute to the distant spread of cancer during surgical treatmentThe presence of circulating tumor cells has been independently associated with both a higher risk of disease recurrence and reduced survival in both nonmetastatic and metastatic breast cancer WHAT THIS ARTICLE TELLS US THAT IS NEW: The hypothesis that postoperative circulating tumor cell counts would be higher in primary breast cancer patients receiving sevoflurane anesthesia than in those receiving intravenous anesthesia with propofol was tested in a randomized controlled trial of 210 patientsThe type of anesthesia did not affect circulating tumor cell counts over time (median circulating tumor cell count/7.5 ml blood [interquartile range]: for propofol, 1 [0 to 4] at end of surgery (0 h), 1 [0 to 2] at 48 h, and 0 [0 to 1] at 72 h; and for sevoflurane, 1 [0 to 4] at 0 h, 0 [0 to 2] at 48 h, and 1 [0 to 2] at 72 h; rate ratio, 1.27 [95% CI, 0.95 to 1.71]).",2020,"There was no association between natural killer cell activity and circulating tumor cell counts. ","['nonmetastatic and metastatic breast cancer', 'n = 103) anesthesia, and eventually included in the analysis', 'Between March 2014 and April 2018, 210 participants were enrolled, assigned to', 'n = 107) or', 'Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible', 'two centers in Switzerland', 'primary breast cancer patients receiving', 'Primary Breast Cancer Patients']","['sevoflurane anesthesia', 'sevoflurane and propofol', 'sevoflurane or propofol anesthesia', 'sevoflurane', 'propofol']","['natural killer cell activity and tumor cell counts', 'maximal tumor cell counts postoperatively', 'maximal circulating tumor cells value, positivity (cutoff', 'circulating tumor cell counts', 'natural killer cell activity and circulating tumor cell counts', 'postoperative tumor cell counts']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",210.0,0.167967,"There was no association between natural killer cell activity and circulating tumor cell counts. ","[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Hovaguimian', 'Affiliation': 'From the Institute of Anesthesiology, University Hospital of Zurich and University of Zurich, Zurich, Switzerland (F.H., M.S., B.B.-S.) the Epidemiology, Biostatistics and Prevention Institute, Department of Public and Global Health (F.H.) the Epidemiology, Biostatistics and Prevention Institute, Department of Epidemiology (J.B., M.A.P.) the Institute of Physiology and Zurich Center for Integrative Human Physiology (B.R.Z., M.S., B.B.-S.) the Cytometry Facility (C.D., C.E.), University of Zurich, Zurich, Switzerland the Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland (K.J.D., D.F.) the Institute of Anesthesiology, Hirslanden Clinic Zurich, Zurich, Switzerland (U.R., M.S.) the Faculty of Medicine, University of Basel, Basel, Switzerland (M.S.) the Department of Surgery (C.T.) the Clinical Trial Unit (B.P.), Breast Center Zurich, Zurich, Switzerland the Department of Anesthesiology, University of Illinois College of Medicine at Chicago, Chicago, Illinois (B.B.-S.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': ''}, {'ForeName': 'Birgit Roth', 'Initials': 'BR', 'LastName': ""Z'graggen"", 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schläpfer', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dumrese', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ewald', 'Affiliation': ''}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Rölli', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Seeberger', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tausch', 'Affiliation': ''}, {'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Papassotiropoulos', 'Affiliation': ''}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Beck-Schimmer', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003409'] 2183,32568857,Personalized Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome: Comparison Between Optimal Distribution of Regional Ventilation and Positive Transpulmonary Pressure.,"OBJECTIVES Different techniques exist to select personalized positive end-expiratory pressure in patients affected by the acute respiratory distress syndrome. The positive end-expiratory transpulmonary pressure strategy aims to counteract dorsal lung collapse, whereas electrical impedance tomography could guide positive end-expiratory pressure selection based on optimal homogeneity of ventilation distribution. We compared the physiologic effects of positive end-expiratory pressure guided by electrical impedance tomography versus transpulmonary pressure in patients affected by acute respiratory distress syndrome. DESIGN Cross-over prospective physiologic study. SETTING Two academic ICUs. PATIENTS Twenty ICU patients affected by acute respiratory distress syndrome undergoing mechanical ventilation. INTERVENTION Patients monitored by an esophageal catheter and a 32-electrode electrical impedance tomography monitor underwent two positive end-expiratory pressure titration trials by randomized cross-over design to find the level of positive end-expiratory pressure associated with: 1) positive end-expiratory transpulmonary pressure (PEEPPL) and 2) proportion of poorly or nonventilated lung units (Silent Spaces) less than or equal to 15% (PEEPEIT). Each positive end-expiratory pressure level was maintained for 20 minutes, and afterward, lung mechanics, gas exchange, and electrical impedance tomography data were collected. MEASUREMENTS AND MAIN RESULTS PEEPEIT and PEEPPL differed in all patients, and there was no correlation between the levels identified by the two methods (Rs = 0.25; p = 0.29). PEEPEIT determined a more homogeneous distribution of ventilation with a lower percentage of dependent Silent Spaces (p = 0.02), whereas PEEPPL was characterized by lower airway-but not transpulmonary-driving pressure (p = 0.04). PEEPEIT was significantly higher than PEEPPL in subjects with extrapulmonary acute respiratory distress syndrome (p = 0.006), whereas the opposite was true for pulmonary acute respiratory distress syndrome (p = 0.03). CONCLUSIONS Personalized positive end-expiratory pressure levels selected by electrical impedance tomography- and transpulmonary pressure-based methods are not correlated at the individual patient level. PEEPPL is associated with lower dynamic stress, whereas PEEPEIT may help to optimize lung recruitment and homogeneity of ventilation. The underlying etiology of acute respiratory distress syndrome could deeply influence results from each method.",2020,"PEEPEIT determined a more homogeneous distribution of ventilation with a lower percentage of dependent Silent Spaces (p = 0.02), whereas PEEPPL was characterized by lower airway-but not transpulmonary-driving pressure (p = 0.04).","['Twenty ICU patients affected by acute respiratory distress syndrome undergoing mechanical ventilation', 'patients affected by the acute respiratory distress syndrome', 'patients affected by acute respiratory distress syndrome', 'Acute Respiratory Distress Syndrome', 'Two academic ICUs']","['PEEPPL', 'Personalized Positive End-Expiratory Pressure', 'positive end-expiratory pressure guided by electrical impedance tomography versus transpulmonary pressure', 'Patients monitored by an esophageal catheter and a 32-electrode electrical impedance tomography monitor underwent two positive end-expiratory pressure titration trials by randomized cross-over design to find the level of positive end-expiratory pressure associated with: 1) positive end-expiratory transpulmonary pressure (PEEPPL) and 2) proportion of poorly or nonventilated lung units (Silent Spaces) less than or equal to 15% (PEEPEIT', 'Regional Ventilation and Positive Transpulmonary Pressure']",['pulmonary acute respiratory distress syndrome'],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]",20.0,0.161415,"PEEPEIT determined a more homogeneous distribution of ventilation with a lower percentage of dependent Silent Spaces (p = 0.02), whereas PEEPPL was characterized by lower airway-but not transpulmonary-driving pressure (p = 0.04).","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Scaramuzzo', 'Affiliation': ""Department of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': ""Department of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Dalla Corte', 'Affiliation': ""Department of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Waldmann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Stephan H', 'Initials': 'SH', 'LastName': 'Böhm', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Ragazzi', 'Affiliation': ""Department of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Marangoni', 'Affiliation': ""Department of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Volta', 'Affiliation': ""Department of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004439'] 2184,32568867,Entecavir add-on Peg-interferon therapy plays a positive role in reversing hepatic fibrosis in treatment-naïve chronic hepatitis B patients: a prospective and randomized controlled trial.,"BACKGROUND The efficacy of entecavir (ETV) add-on peg-interferon therapy compared with ETV monotherapy in treatment-naïve hepatitis B virus (HBV) patients remains controversial. We investigated whether adding peg-interferon to ongoing ETV treatment leads to a better curative effect or not. METHODS All patients have been recruited between August 2013 and January 2015 from the Shanghai Public Health Clinical Center and Zhongshan Hospital (China). Eligible HBV patients (n = 144) were randomly divided (1:1) to receive either ETV monotherapy (n = 70) or peg-interferon add-on therapy from weeks 26 to 52 (n = 74). Patients were followed-up for at least 2 years. Indexes including hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) seroconversion rate, sustained virologic response, transient elastography value, and histological scores were evaluated every 3 months until the end of the study. The rate of patients with HBsAg loss was defined as the primary endpoint criteria. RESULTS At week 26, no patient achieved HBsAg seroconversion in either group. At week 52, one patient in the monotherapy group was HBsAg-negative but there was none in the combination therapy group. The monotherapy group showed significantly better liver function recovery results than the combination therapy group. At week 78, one patient in the combination group had HBsAg seroconverted. At week 104, only three patients in the combination therapy group were HBsAg-negative compared with one patient in monotherapy. The mean alanine aminotransferase and aspartate aminotransferase levels and transient elastography values decreased significantly compared with baseline. Both groups showed a favorable decrease in alpha-fetoprotein (monotherapy: 4.5 [2.8, 7.1] vs. 2.2 [1.8, 3.1] ng/mL, P < 0.001; combination therapy: 5.7 [3.0, 18.8] vs. 3.2 [2.0, 4.3] ng/mL, P < 0.001) and an improved result of liver biopsy examination scores. The combination group showed a better improvement in histology compared with the monotherapy group (mean transient elastography value 6.6 [4.9, 9.8] vs. 7.8 [5.4, 11.1] kPa, P = 0.028). But there was no significant difference in HBsAg conversion rate (1.8% [1/56] vs. 4.1% [3/73], P = 0.809) and HBeAg conversion rate (12.5% [7/56] vs. 11.0% [8/73], P = 0.787), as well as HBV-DNA, sustained virologic response (93.2% vs. 98.5%, P = 0.150) between the two groups. CONCLUSIONS Both therapies supported liver function recovery and histology improvement. Combination therapy did not show better anti-viral efficacy in HBsAg or HBeAg seroconversion compared with monotherapy. However, combination therapy played a more positive role in reversing hepatic fibrosis compared with monotherapy. TRIAL REGISTRATION ClinicalTrials.gov: NCT02849132; https://clinicaltrials.gov/ct2/show/NCT02849132.",2020,"The combination group showed a better improvement in histology compared with the monotherapy group (mean transient elastography value 6.6 [4.9, 9.8] vs. 7.8 [5.4, 11.1] kPa, P = 0.028).","['treatment-naïve chronic hepatitis B patients', 'All patients have been recruited between August 2013 and January 2015 from the Shanghai Public Health Clinical Center and Zhongshan Hospital (China', 'Eligible HBV patients (n = 144']","['Entecavir', 'entecavir (ETV', 'ETV monotherapy (n\u200a=\u200a70) or peg-interferon add-on therapy', 'ETV monotherapy']","['mean alanine aminotransferase and aspartate aminotransferase levels and transient elastography values', 'hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) seroconversion rate, sustained virologic response, transient elastography value, and histological scores', 'HBsAg seroconversion', 'HBsAg-negative', 'hepatic fibrosis', 'histology', 'rate of patients with HBsAg loss', 'HBeAg conversion rate', 'liver function recovery', 'alpha-fetoprotein', 'HBV-DNA, sustained virologic response', 'liver biopsy examination scores', 'HBsAg conversion rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0919711', 'cui_str': 'Hepatitis B surface antigen negative'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",144.0,0.0480929,"The combination group showed a better improvement in histology compared with the monotherapy group (mean transient elastography value 6.6 [4.9, 9.8] vs. 7.8 [5.4, 11.1] kPa, P = 0.028).","[{'ForeName': 'Jing-Mao', 'Initials': 'JM', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Chen', 'Affiliation': 'Shanghai Medical College of Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Ya-Jie', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Jinshan Hospital, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Lyu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Department of Gastroenterology and Hepatology, Dongyang People's Hospital, Dongyang, Zhejiang 322100, China.""}, {'ForeName': 'Zhi-Yin', 'Initials': 'ZY', 'LastName': 'Shang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Zhen-Yu', 'Initials': 'ZY', 'LastName': 'Fan', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Sheng-Di', 'Initials': 'SD', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ming', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Shao-Ping', 'Initials': 'SP', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}, {'ForeName': 'Ji-Lin', 'Initials': 'JL', 'LastName': 'Cheng', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201500, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000857'] 2185,32568876,Effect of temperature maintenance by forced-air warming blankets of different temperatures on changes in inflammatory factors in children undergoing congenital hip dislocation surgery.,"BACKGROUND Hypothermia is associated with many adverse clinical outcomes in pediatric patients, and thus, it is important to find an effective and safe method for preventing peri-operative hypothermia and its associated adverse outcomes in pediatric patients. This study aimed to investigate the effect of forced-air warming blankets with different temperatures on changes in the transforming growth factor-β (TGF-β), tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and IL-10 levels in children undergoing surgical treatment for developmental displacement of the hip (DDH). METHODS The study included 123 children undergoing surgery for DDH under general anesthesia. The patients were randomly assigned to three groups, using a random number table: the 32, 38, and 43°C groups according to the temperature setting of the forced-air warming blankets. For each patient, body temperature was recorded immediately after anesthesia induction and intubation (T0), at initial incision (T1), at 1 h after incision (T2), at 2 h after incision (T3), at the end of surgery (T4), immediately upon return to the ward after surgery (T5), and then at 12 h (T6), 24 h (T7), 36 h (T8), and 48 h (T9) after the surgery. The serum levels of TGF-β, TNF-α, IL-1β, and IL-10 were measured at T0 and T4 for all groups. RESULTS The number of patients with fever in the 38°C group was significantly less than those in the 32 and 43°C groups (χ = 6.630, P = 0.036). At T0, the body temperatures in the 38 and 43°C groups were significantly higher than that in the 32°C group (F = 17.992, P < 0.001). At T2, the body temperature was significantly higher in the 43°C group than those in the 32 and 38°C groups (F = 12.776, P < 0.001). Moreover, at T4, the serum levels of TGF-β (F = 3286.548, P < 0.001) and IL-10 (F = 4628.983, P < 0.001) were significantly increased in the 38°C group, and the serum levels of TNF-α (F = 911.415, P < 0.001) and IL-1β (F = 322.191, P < 0.001) were significantly decreased in the 38°C group, compared with the levels in the 32 and 43°C groups. CONCLUSIONS Force-air warming blankets set at 38°C maintained stable body temperature with less adverse outcome and effectively inhibited the inflammatory response in pediatric patients undergoing surgery for DDH. CLINICAL TRIAL REGISTRATION ChiCTR1800014820; http://www.chictr.org.cn/showproj.aspx?proj=25240.",2020,"The serum levels of TGF-β, TNF-α, IL-1β, and IL-10 were measured at T0 and T4 for all groups. ","['pediatric patients', 'pediatric patients undergoing surgery for DDH', 'children undergoing congenital hip dislocation surgery', 'children undergoing surgical treatment for developmental displacement of the hip (DDH', '123 children undergoing surgery for DDH under general anesthesia']","['temperature maintenance by forced-air warming blankets', 'forced-air warming blankets']","['IL-1β', 'serum levels of TGF-β, TNF-α, IL-1β, and IL-10', 'serum levels of TGF-β', 'body temperature', 'transforming growth factor-β (TGF-β), tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and IL-10 levels', 'serum levels of TNF-α', 'number of patients with fever', 'IL-10', 'body temperatures', 'inflammatory response']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019555', 'cui_str': 'Congenital dislocation of hip'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184351', 'cui_str': 'Warming blanket'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",123.0,0.057569,"The serum levels of TGF-β, TNF-α, IL-1β, and IL-10 were measured at T0 and T4 for all groups. ","[{'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'He', 'Affiliation': ""Department of Operation Room, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, Guangdong 510623, China.""}, {'ForeName': 'Pei-Zhen', 'Initials': 'PZ', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yuan-Ming', 'Initials': 'YM', 'LastName': 'Wen', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000846'] 2186,32568887,Letter to the Editor: Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.,,2020,,['1187 Patients'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.137678,,"[{'ForeName': 'Zhen Chang', 'Initials': 'ZC', 'LastName': 'Liang', 'Affiliation': 'Z. C. Liang, M. S. Y. Chong, S. S. Tan, B. Z. Chin, D. Murphy, J. H. P. Hui, National University of Singapore, Department of Orthopaedic Surgery, National University Health System, Singapore.'}, {'ForeName': 'Mark Seng Ye', 'Initials': 'MSY', 'LastName': 'Chong', 'Affiliation': ''}, {'ForeName': 'Sara Shuhui', 'Initials': 'SS', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Brian Zhaojie', 'Initials': 'BZ', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Diarmuid', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'James Hoi Po', 'Initials': 'JHP', 'LastName': 'Hui', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001331'] 2187,32568897,A Computer-Based Tutor to Teach Nursing Trauma Care That Works as an Adjunct to High-Fidelity Simulation.,"Educators are challenged to prepare nurses to care for low-frequency, high-stakes problems such as trauma. Computer-based tutors provide a cost-effective teaching strategy without risking patient safety. Evidence for the efficacy of this type of instruction is limited; thus, we tested the learning outcomes of a tutor on trauma care knowledge with senior nursing students. Participants were randomly assigned to either the tutor or a control condition (textbook learning). Instructional design elements incorporated into the tutor included use of multimedia content, emphasis of key points, frequent quizzing with instant feedback, and unfolding case studies to summarize key concepts. Use of the tutor led to a larger increase in trauma nursing knowledge than use of a textbook. In addition, the knowledge was retained as well as book-based learning. The effect size of the tutor, 1.15, was relatively high as well-the average for computer tutors is 0.79. Qualitative focus groups revealed that participants expressed favorable views of the tutor in comparison to textbook learning. They found it more engaging and more enjoyable and reported that it effectively organized the content. The results of this study support the efficacy of a well-designed computer-based tutor for learning key concepts of trauma nursing.",2020,"The effect size of the tutor, 1.15, was relatively high as well-the average for computer tutors is 0.79.",['senior nursing students'],"['Computer-Based Tutor to Teach Nursing Trauma Care', 'control condition (textbook learning']",['trauma nursing knowledge'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0173965,"The effect size of the tutor, 1.15, was relatively high as well-the average for computer tutors is 0.79.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Garrison', 'Affiliation': 'Author Affiliations: College of Nursing (Dr Garrison) and College of IST (Dr Ritter), Penn State, University Park, Pennsylvania; and Charles River Analytics, Cambridge, Maryland (Mr Bauchwitz and Drs Niehaus and Weyhrauch).'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Ritter', 'Affiliation': ''}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Bauchwitz', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Niehaus', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Weyhrauch', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000637'] 2188,32568929,The Myopic Shift in Aphakic Eyes in the Infant Aphakia Treatment Study After 10 Years of Follow-up.,"OBJECTIVES To report the myopic shift in the aphakic eyes of a cohort of children who underwent unilateral cataract surgery during infancy and were then followed longitudinally for 10.5 years. METHODS One-half of the children enrolled in the Infant Aphakia Treatment Study (IATS) were randomized to aphakia and contact lens correction after unilateral cataract surgery. They then underwent ocular examinations using standardized protocols at prescribed time intervals until age 10.5 years. RESULTS Thirty of 57 children randomized to aphakia remained aphakic at age 10.5, having undergone unilateral cataract surgery at a median age of 1.6 (IQR: 1.1-3.1) months. The median refractive error (RE) in the 57 eyes randomized to aphakia immediately after cataract surgery was 19.01 D (IQR: 16.98-20.49) compared to 10.38 D (IQR: 7.50-14.00) for the 30 eyes that remained aphakic at age 10.5 years. The mean change in RE in aphakic eyes was -2.11 D/year up to age 1.5 years, -0.68 D/year from 1.5 to 5.0 years, and -0.35 D/year from age 5 to 10.5 years. At age 10.5 years, 18 patients continued to wear a contact lens correction (silicone elastomer, n=6; gas permeable, n=6; hydrogel, n=5; and silicone hydrogel, n=1) (median RE, 12.50 D), 9 wore only spectacles (median RE, 4.00 D), and 4 wore no correction (median RE, 11.25 D) to correct their aphakic eye. CONCLUSIONS The RE in aphakic eyes decreased by 44% from infancy to age 10.5 years. About two-thirds of children who remained aphakic at age 10.5 years continued to wear a contact lens.",2020,"Thirty of 57 children randomized to aphakia remained aphakic at age 10.5, having undergone unilateral cataract surgery at a median age of 1.6 (IQR: 1.1-3.1) months.","['children who remained aphakic at age 10.5 years continued to wear a contact lens', 'Thirty of 57 children randomized to aphakia remained aphakic at age 10.5, having undergone unilateral cataract surgery at a median age of 1.6 (IQR: 1.1-3.1) months', 'At age 10.5 years, 18 patients continued to wear a contact lens correction (silicone elastomer, n=6; gas permeable, n=6; hydrogel, n=5; and silicone hydrogel, n=1) (median RE, 12.50 D), 9 wore only spectacles (median RE, 4.00 D), and 4 wore no correction (median RE, 11.25 D) to correct their aphakic eye', 'children enrolled in the Infant Aphakia Treatment Study (IATS']","['unilateral cataract surgery', 'aphakia and contact lens correction after unilateral cataract surgery']","['mean change in RE', 'aphakic eyes', 'median refractive error (RE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037110', 'cui_str': 'Elastomers, Silicone'}, {'cui': 'C0444946', 'cui_str': 'Gas permeable'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C4517532', 'cui_str': '11.25'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",57.0,0.0311551,"Thirty of 57 children randomized to aphakia remained aphakic at age 10.5, having undergone unilateral cataract surgery at a median age of 1.6 (IQR: 1.1-3.1) months.","[{'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Lambert', 'Affiliation': 'Department of Ophthalmology (S.R.L.), Stanford University School of Medicine, Palo Alto, CA; Department of Biostatistics and Bioinformatics (A.N., G.C.), Rollins School of Public Health, Emory University, Atlanta, GA; Department of Ophthalmology (L.D.), School of Medicine, Emory University, Atlanta, GA; Department of Ophthalmology (D.R.W.), Southwestern University, Dallas, TX; and Storm Eye Institute (M.E.W.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam', 'Affiliation': ''}, {'ForeName': 'Lindreth', 'Initials': 'L', 'LastName': 'DuBois', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Weakley', 'Affiliation': ''}, {'ForeName': 'M Edward', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000718'] 2189,32568935,Apoyo con Cariño: A Qualitative Analysis of a Palliative Care-Focused Lay Patient Navigation Intervention for Hispanics With Advanced Cancer.,"A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado. Five home visits were delivered over 3 months to 112 patients assigned to the randomized controlled trial's intervention arm. Grounded in core Hispanic values, visits addressed palliative care domains (advance care planning, pain/symptom management, and hospice utilization). To describe the content of patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients. Based on previous work, codes were established a priori to identify ways patient navigators help patients/family caregivers. Key words and comments from field notes were classified into themes using ATLAS.ti and additional codes established. Nine common themes and exemplars describing the lay patient navigator role are described: activation/empowerment, advocacy, awareness, access, building rapport, providing support, exploring barriers, symptom screening, and the patient experience. Patient navigators used advocacy, activation, education, and motivational interviewing to address patient/family concerns and reduce barriers to quality palliative care in urban and rural settings. Adapting and implementing this model across cultures has potential to improve palliative care access to underserved populations.",2020,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"['Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado', ""patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients"", 'Hispanics With Advanced Cancer', 'urban and rural settings']","['culturally tailored intervention', 'Palliative Care-Focused Lay Patient Navigation Intervention']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}]",[],,0.0265818,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"[{'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Fink', 'Affiliation': 'Regina M. Fink, PhD, APRN, CHPN, FAAN, is professor and codirector, Interprofessional Master of Science in Palliative Care Program, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Danielle M. Kline, MS, is senior professional research assistant, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Shaunna Siler, PhD, RN, is palliative care & aging research fellow and T-32 scholar, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Stacy M. Fischer, MD, is associate professor, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Kline', 'Affiliation': ''}, {'ForeName': 'Shaunna', 'Initials': 'S', 'LastName': 'Siler', 'Affiliation': ''}, {'ForeName': 'Stacy M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000666'] 2190,32569031,"Effects of Lubiprostone, an Intestinal Secretagogue, on Electrolyte Homeostasis in Chronic Idiopathic and Opioid-induced Constipation.","GOALS To assess short-term and long-term effects of lubiprostone, a type-2 chloride channel activator, on electrolyte homeostasis. BACKGROUND Conventional laxatives are associated with electrolyte imbalances. Lubiprostone is a type-2 chloride channel activator approved for treating chronic idiopathic constipation (CIC), opioid-induced constipation (OIC), and constipation-predominant irritable bowel syndrome in women. It induces intestinal fluid secretion, possibly affecting water and electrolyte homeostasis. We investigated short-term and long-term effects of lubiprostone on electrolyte, blood urea nitrogen (BUN), and creatinine levels using pooled data from CIC and OIC patients. STUDY Data were pooled from 10 CIC and OIC studies-6 double-blind, randomized, placebo-controlled studies and 4 open-label, long-term studies. Total duration of lubiprostone exposure was from 3 weeks (short-term: CIC, 3 to 4 wk; OIC, placebo-controlled, 12 wk) to 48 weeks (long-term: CIC, 24 to 48 wk; OIC, 48 wk). Sodium, chloride, potassium, magnesium, BUN, and creatinine levels were examined at baseline and final assessment. RESULTS Overall, 3209 patients were assessed. In the double-blind, placebo-controlled studies, there were no clinically meaningful differences in levels of electrolytes, BUN, and creatinine between lubiprostone and placebo groups, and in changes from baseline levels with long-term use of lubiprostone. Analyses of shifts in laboratory values (low/normal/high) at baseline and final assessment showed minimal effects on electrolytes, BUN, and creatinine. CONCLUSIONS Lubiprostone did not cause clinically meaningful electrolyte imbalances or affect markers of renal function in either the short-term or long-term treatment of CIC or OIC.",2020,"CONCLUSIONS Lubiprostone did not cause clinically meaningful electrolyte imbalances or affect markers of renal function in either the short-term or long-term treatment of CIC or OIC.","['Chronic Idiopathic and Opioid-induced Constipation', '3209 patients were assessed']","['lubiprostone', 'Lubiprostone', 'placebo']","['levels of electrolytes, BUN, and creatinine', 'renal function', 'electrolytes, BUN, and creatinine', 'Sodium, chloride, potassium, magnesium, BUN, and creatinine levels', 'Total duration of lubiprostone exposure', 'electrolyte, blood urea nitrogen (BUN), and creatinine levels']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",3209.0,0.203981,"CONCLUSIONS Lubiprostone did not cause clinically meaningful electrolyte imbalances or affect markers of renal function in either the short-term or long-term treatment of CIC or OIC.","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Augusta University Medical Center, Augusta, GA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lichtlen', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Zug, Switzerland.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Habibi', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Rockville, MD.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001385'] 2191,32569033,Treatment for Clubfoot: Stockinette Versus Webril Cast Padding in the Ponseti Method.,"BACKGROUND The Ponseti method of serial manipulation and casting revolutionized the treatment of one of the most common congenital orthopaedic conditions-clubfoot-resulting in less surgical morbidity and better functional results. Several studies have examined aspects of nonoperative treatment but none have explored the effect of different types of undercast padding. METHODS The authors performed a randomized controlled trial comparing cotton Stockinette and Webril undercast padding using the Ponseti method. They included 56 patients under the age of 6 months who had an untreated idiopathic clubfoot. For treatment, the padding was randomized to double-layer Stockinette (29 patients) or standard 2- to 3-layer Webril (27 patients). The primary analysis consisted of a 2-sample t test comparing the mean number of casts required for correction in each group. Secondary outcomes included initial and final standardized clubfoot scores (Pirani and Dimeglio scores) and adverse events. RESULTS Baseline demographics were not statistically different between groups, with respect to mean age, sex, and side being treated, nor were the baseline Dimeglio and Pirani scores. The primary outcome analysis revealed an equivalent number of casts (about 4) required before tenotomy. The secondary analysis on complications did not show any significant difference, with 10 events documented in the Webril group and 9 in the Stockinette group (P=1.00). At the end of the study, the mean Dimeglio (3.9±2.1 vs. 3.9±1.8, P=0.99) and Pirani (2.1±0.8 vs. 2.2±0.8, P=0.70) scores were not significantly different. Subjectively, parents and doctors indicated a substantially more positive experience for the Stockinette group. CONCLUSIONS Webril and Stockinette paddings provide equivalent clubfoot deformity correction while applying a similar number of casts before tenotomy. Although minor skin complications were observed, these were not significantly different between groups.",2020,"RESULTS Baseline demographics were not statistically different between groups, with respect to mean age, sex, and side being treated, nor were the baseline Dimeglio and Pirani scores.",['56 patients under the age of 6 months who had an untreated idiopathic clubfoot'],"['double-layer Stockinette (29 patients) or standard 2- to 3-layer Webril', 'cotton Stockinette and Webril undercast padding using the Ponseti method']","['mean Dimeglio', 'equivalent number of casts (about 4) required before tenotomy', 'skin complications', 'mean number of casts required for correction', 'initial and final standardized clubfoot scores (Pirani and Dimeglio scores) and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183614', 'cui_str': 'Stockinette'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0441601', 'cui_str': 'Padding'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0407093', 'cui_str': 'Adductor tenotomy of hip'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",56.0,0.130679,"RESULTS Baseline demographics were not statistically different between groups, with respect to mean age, sex, and side being treated, nor were the baseline Dimeglio and Pirani scores.","[{'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Marien', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Abouassaly', 'Affiliation': ""Division of Orthopaedic Surgery, Alberta Children's Hospital, Calgary, AL, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Smit', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kontio', 'Affiliation': ""Division of Orthopaedic Surgery, Children's Hospital of Eastern Ontario, Ottawa, ON.""}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001617'] 2192,32569068,Systemic Absorption and Nephrotoxicity Associated with Topical Vancomycin Powder for Fracture Surgery.,"OBJECTIVES To determine if using topical vancomycin powder in fracture surgery may result in low levels of vancomycin in the serum and not result in nephrotoxicity. DESIGN Prospective observational at a single site as a sub-study of the VANCO trial. SETTING Single, large urban Level I trauma center PATIENTS/PARTICIPANTS:: Fifty-eight patients with tibial plateau and pilon fractures randomized to the treatment arm at the principal investigator's site. INTERVENTION Topical vancomycin powder (1000 mg) applied directly in the wound over all metal implants at the time of wound closure. MAIN OUTCOME MEASUREMENTS Serum vancomycin levels at 1 hour and 6-8 hours following surgery. Secondary outcomes included serum creatinine prior to surgery, a day after surgery and at 2 weeks postoperatively and complete blood count at 2 weeks postoperatively. RESULTS Excepting 2 patients who also received intravenous vancomycin, none of the study patients had detectable (>5 µg/ml) serum vancomycin levels at 1 hour and 6-8 hours following surgery. One patient with a prior history of elevation of serum creatinine had a minor increase of serum creatinine but had undetectable vancomycin levels. None of the other patients had a clinically significant increase in creatinine levels. CONCLUSIONS Despite its relatively widespread usage, little data exists regarding the systemic levels and nephrotoxicity associated with the topical use of vancomycin powder in orthopaedic fracture surgery. These prospective data indicate that there appears to be little clinical concern regarding toxicity associated with systemic absorption of vancomycin powder in this specific clinical application. LEVEL OF EVIDENCE Level IV. See Instructions for Authors for a complete description of levels of evidence.",2020,One patient with a prior history of elevation of serum creatinine had a minor increase of serum creatinine but had undetectable vancomycin levels.,"[""Single, large urban Level I trauma center PATIENTS/PARTICIPANTS:: Fifty-eight patients with tibial plateau and pilon fractures randomized to the treatment arm at the principal investigator's site"", 'Fracture Surgery']","['intravenous vancomycin', 'topical vancomycin powder', 'Topical vancomycin powder', 'vancomycin powder', 'Topical Vancomycin Powder']","['serum vancomycin levels', 'Serum vancomycin levels', 'Systemic Absorption and Nephrotoxicity', 'serum creatinine', 'serum creatinine prior to surgery, a day after surgery and at 2 weeks postoperatively and complete blood count', 'creatinine levels']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure'}, {'cui': 'C0435895', 'cui_str': 'Pilon fracture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1521895', 'cui_str': 'Principal investigator'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C1278120', 'cui_str': 'Serum vancomycin measurement'}, {'cui': 'C3850076', 'cui_str': 'Absorption, Systemic'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}]",58.0,0.152973,One patient with a prior history of elevation of serum creatinine had a minor increase of serum creatinine but had undetectable vancomycin levels.,"[{'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore Maryland.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Degani', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore Maryland.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Carlini', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore Maryland.'}, {'ForeName': 'Renan C', 'Initials': 'RC', 'LastName': 'Castillo', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore Maryland.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore Maryland.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Division of infectious Diseases, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001866'] 2193,32569082,Are endogenous opioid mechanisms involved in the effects of aerobic exercise training on chronic low back pain?: a randomized controlled trial.,"Aerobic exercise is believed to be an effective chronic low back pain (CLBP) intervention, although its mechanisms remain largely untested. This study evaluated whether endogenous opioid (EO) mechanisms contributed to the analgesic effects of an aerobic exercise intervention for CLBP. Individuals with CLBP were randomized to a 6-week, 18-session aerobic exercise intervention (n = 38) or usual activity control (n = 44). Before and after the intervention, participants underwent separate laboratory sessions to assess responses to evoked heat pain after receiving saline placebo or i.v. naloxone (opioid antagonist) in double-blinded, crossover fashion. Chronic pain intensity and interference were assessed before and after the intervention. EO analgesia was indexed by naloxone-placebo condition differences in evoked pain responses (blockade effects). Relative to controls, exercise participants reported significantly greater pre-post intervention decreases in chronic pain intensity and interference (p's < .04) and larger reductions in placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total). At the group level, EO analgesia (MPQ-Total blockade effects) increased significantly pre-post intervention only among female exercisers (p = .03). Dose-response effects were suggested by a significant positive association in the exercise group between exercise intensity (based on meeting heart rate targets) and EO increases (MPQ-Present Pain Intensity; p = .04). Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009). Aerobic exercise training in the absence of other interventions appears effective for CLBP management. Aerobic exercise-related enhancements in endogenous pain inhibition, in part EO-related, likely contribute to these benefits.",2020,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,['Individuals with CLBP'],"['aerobic exercise intervention', 'naloxone-placebo', 'aerobic exercise training', '18-session aerobic exercise intervention', 'naloxone (opioid antagonist', 'Aerobic exercise', 'endogenous opioid (EO', 'Aerobic exercise training', 'usual activity control', 'saline placebo']","['chronic pain intensity and interference', 'evoked pain responses', 'Chronic pain intensity and interference', 'EO analgesia (MPQ-Total blockade effects', 'placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total', 'Enhanced EO analgesia (MPQ-Total', 'EO analgesia', 'average chronic pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",44.0,0.37122,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Koltyn', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yung Hsuan', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': ""Qu'd"", 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Pain,['10.1097/j.pain.0000000000001969'] 2194,32569087,"Factors with impact on magnitude of the placebo response in randomized, controlled, cross-over trials in peripheral neuropathic pain.","The presence and magnitude of placebo responses is important for the outcome in clinical trials of analgesics. This explorative study aimed at identifying patients and trial specific factors with impact on this response in randomized, controlled, cross-over trials in peripheral neuropathic pain. Data were derived from 7 trials and included observations on pin-prick hyperalgesia, allodynia, and pain on repetitive stimulation. The studies were all performed by the same collaboration group in Denmark. Pain was rated daily using numeric 0-10 point rating scales (NRS) and placebo response was calculated as the difference in weekly average or median NRS from baseline to the last week of treatment. A clinically meaningful placebo response was defined as more than 30% reduction of pain on placebo. In 318 individual observations the response was on average small (0.17 points, range -4.5 to 6). There was no significant impact on size of placebo response of trial specific factors such as treatment sequence and chance of having placebo treatment in each period or of the patient specific factors age, sensory signs and pain symptoms. The findings were similar in patients having placebo in the first treatment period. There was no marked difference between patients with and without a clinically meaningful placebo response with respect to the patient specific factors including frequency of sensory signs and symptoms. In conclusion, this study on cross-over trials in peripheral neuropathic pain found no robust impact of trial and patient specific factors on the placebo response.",2020,"There was no significant impact on size of placebo response of trial specific factors such as treatment sequence and chance of having placebo treatment in each period or of the patient specific factors age, sensory signs and pain symptoms.",['peripheral neuropathic pain'],['placebo'],"['size of placebo response', 'Pain was rated daily using numeric 0-10 point rating scales (NRS) and placebo response', 'pain', 'pin-prick hyperalgesia, allodynia, and pain on repetitive stimulation']","[{'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",,0.400856,"There was no significant impact on size of placebo response of trial specific factors such as treatment sequence and chance of having placebo treatment in each period or of the patient specific factors age, sensory signs and pain symptoms.","[{'ForeName': 'Mimmi', 'Initials': 'M', 'LastName': 'Gillving', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Dyveke', 'Initials': 'D', 'LastName': 'Demant', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lund', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jakob V', 'Initials': 'JV', 'LastName': 'Holbech', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Otto', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Troels S', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Flemming W', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Nanna B', 'Initials': 'NB', 'LastName': 'Finnerup', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Søren H', 'Initials': 'SH', 'LastName': 'Sindrup', 'Affiliation': 'Department of Neurology and Neurology Research Unit, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}]",Pain,['10.1097/j.pain.0000000000001964'] 2195,32569090,"Intrathecal delivery of hydromorphone vs morphine for refractory cancer pain: a multicenter, randomized, single-blind, controlled noninferiority trial.","Hydromorphone is an alternative to morphine for Intrathecal Drug Delivery System (IDDS) to treat refractory cancer pain; however, there is not enough clinical evidence to prove it. In our study, 233 patients from 12 different pain management centers across China were enrolled, 121 and 112 in the intrathecal hydromorphone (ITHM) and intrathecal morphine (ITMO) groups, respectively. The primary outcome was the clinical success rate, which was defined as ratio of patients achieving ≥ 50% pain relief. The noninferiority margin (NIm) was defined as -0.15. Other outcomes included daily visual analog scale (VAS) score, breakthrough pain (BTP) incidence, intrathecal dose change and PCA bolus count change, GAD-7/PHQ-9. Clinical success was achieved in 85 and 79 of the 121 ITHM patients (70.2%) and 112 ITMO patients (70.5%), respectively. Compared to the corresponding baseline findings, significantly decreased VAS scores and BTP incidence were noted in both groups. The dose change rate decreased and increased with time in the ITHM and ITMO groups, respectively (ITHM -3.33% vs ITMO 35.4%, P < .01, t-test) from the third week. The PCA bolus change rate was lower in the ITHM group than in the ITMO group (ITHM - 19.88% vs ITMO 7.79%, P < .01, t-test) from first week. Our result shows that intrathecal hydromorphone is noninferior to intrathecal morphine on pain relief to treat refractory cancer pain, however, at different doses and that the doses of morphine tended to increase whereas those of hydromorphone decreased over time. Hydromorphone offers advantage over morphine in controlling breakthrough pain.",2020,"The PCA bolus change rate was lower in the ITHM group than in the ITMO group (ITHM - 19.88% vs ITMO 7.79%, P < .01, t-test) from first week.","['233 patients from 12 different pain management centers across China were enrolled, 121 and 112 in the', 'refractory cancer pain']","['hydromorphone', 'ITMO', 'ITHM', 'Hydromorphone', 'intrathecal morphine', 'intrathecal hydromorphone (ITHM) and intrathecal morphine (ITMO', 'hydromorphone vs morphine', 'intrathecal hydromorphone', 'morphine']","['PCA bolus change rate', 'pain relief', 'Clinical success', 'clinical success rate, which was defined as ratio of patients achieving ≥ 50% pain relief', 'VAS scores and BTP incidence', 'daily visual analog scale (VAS) score, breakthrough pain (BTP) incidence, intrathecal dose change and PCA bolus count change, GAD-7/PHQ-9', 'change rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}]",233.0,0.0995406,"The PCA bolus change rate was lower in the ITHM group than in the ITMO group (ITHM - 19.88% vs ITMO 7.79%, P < .01, t-test) from first week.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Pain Medicine, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, No.1995, Kongjiang Road, Shanghai, 200092, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Pain Management Center, Nanjing General Hospital, No. 305, East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pain Medicine, The Affiliated Hospital of Guizhou Medical University, No. 28, Guiyi Street, Guiyang, 510000, China.'}, {'ForeName': 'Zhi-Ying', 'Initials': 'ZY', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, Zhejiang University, No. 79, Qingchun Road, Hangzhou, 310003, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, China Medical University, No. 155, North Nanjing Road, Heping District, Shenyang, 110001, China.'}, {'ForeName': 'Xiao-Qiu', 'Initials': 'XQ', 'LastName': 'Yang', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital of Chongqing Medical University, No. 1, Youyi Road Yuan jiaguang, Yu Zhong Distric, Chongqing, 400016, China.'}, {'ForeName': 'Fu-Qiang', 'Initials': 'FQ', 'LastName': 'Chen', 'Affiliation': 'Department of Pain Medicine, Qingdao Municipal Hospital, No. 1, Jiaozhou Road, Qingdao, 266011, China.'}, {'ForeName': 'Bao-Lin', 'Initials': 'BL', 'LastName': 'Duan', 'Affiliation': ""Department of Pain Medicine, Qinghai Provincial People's Hospital, No. 2, Gonghe Road, Xi'ning, 810007, China.""}, {'ForeName': 'You-Qing', 'Initials': 'YQ', 'LastName': 'Huang', 'Affiliation': 'Department of Pain Medicine, The 2nd Affiliated Hospital of Kunming Medical University, No. 1, Dian Mian Road, Kunming, 650000, China.'}, {'ForeName': 'Guang-Lun', 'Initials': 'GL', 'LastName': 'Xie', 'Affiliation': 'Department of Pain Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, No. 127, Dongming Road, Zhengzhou, 450008, China.'}, {'ForeName': 'Hong-Guang', 'Initials': 'HG', 'LastName': 'Bao', 'Affiliation': 'Department of Pain Medicine, Nanjing First Hospital, Nanjing Medical University, No. 68, Changle Road, Nanjing, 210029, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacometrics, Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, No. 1200, Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Jiang-Tao', 'Initials': 'JT', 'LastName': 'Xu', 'Affiliation': 'Department of Pain Medicine, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, No.1995, Kongjiang Road, Shanghai, 200092, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Pain Medicine, Xijing Hospital, The Fourth Military Medical University, No. 127, West Changle Road, Xi'an, 710032, China.""}, {'ForeName': 'Yan-Qing', 'Initials': 'YQ', 'LastName': 'Liu', 'Affiliation': 'Department of Pain Medicine, Beijing Tiantan Hospital, Capital Medical University, No. 6, Xili, Tiantan, Dongcheng District, Beijing, 100050, China.'}]",Pain,['10.1097/j.pain.0000000000001957'] 2196,32569102,Effects of Massage on Post-Operative Pain in Infants with Complex Congenital Heart Disease.,"BACKGROUND Pain management is an essential component of care for pediatric patients following surgery. Massage reduces self-reported post-operative pain in adults with heart disease but has received little attention in post-operative pediatric patients with congenital heart disease (CCHD). OBJECTIVES To evaluate the effectiveness of massage compared to a rest period on post-operative pain scores and physiologic responses in infants with CCHD. METHODS We used a two-group randomized clinical trial design with a sample of 60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. Group 1 received a daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, GLMM repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate. RESULTS Adjusted pain scores were lower for the massage group on all days except day 7. Overall there were no group effects on level of pain or differential rate of change in pain. However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR. There was little difference between groups in SpO2. Infants demonstrated immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing. DISCUSSION This study provides beginning evidence that post-operative massage may reduce pain and improve physiologic parameters in infants with congenital heart disease. This non-pharmacological adjunct to pain management may provide a particular benefit for this population by reducing demand on the cardiorespiratory system.",2020,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","['infants with CCHD', 'adults with heart disease', 'pediatric patients with congenital heart disease (CCHD', 'infants with congenital heart disease', 'pediatric patients following surgery', '60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery', 'Infants with Complex Congenital Heart Disease']","['standard post-operative care', 'daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage', 'Fentanyl-equivalent narcotic values', 'Massage']","['Daily averages and pre- and post- intervention FLACC scores and physiologic responses', 'Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2', 'Pain', 'Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC', 'immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing', 'daily pain scores', 'Adjusted pain scores', 'level of pain or differential rate of change in pain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0852710', 'cui_str': 'Oxygen saturation increased'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.174636,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","[{'ForeName': 'Tondi M', 'Initials': 'TM', 'LastName': 'Harrison', 'Affiliation': ""The Ohio State University College of Nursing, Columbus, Ohio University of Wisconsin-Madison School of Nursing, Madison, Wisconsin Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio COPC Ohio Center for Pediatrics, Dublin, Ohio The Ohio State University College of Nursing, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Duffey', 'Affiliation': ''}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Frey', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fitch', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000459'] 2197,32569120,Effects of Different Resistance Training Loads on the Muscle Quality Index in Older Women.,"Ribeiro, AS, Picoloto, A, Nunes, JP, Bezerra, ES, Schoenfeld, BJ, and Cyrino, ES. Effects of different resistance training loads on the muscle quality index in older women. J Strength Cond Res XX(X): 000-000, 2020-The purpose of this study was to investigate the effects of resistance training (RT) performed using low vs. moderate loads on muscular strength, muscle mass, and muscle quality index (MQI) in older women. Twenty-seven older women (71.5 ± 5 years, 65.2 ± 11 kg, 154.2 ± 5 cm, and 27.4 ± 4 kg·m) were randomized into 2 groups: one that performed RT with a low load (LOW, n = 13) and another that performed RT with a moderate load (MOD, n = 14). An 8-week RT program was performed 3 d·wk. Outcomes included 1-repetition maximum (1RM) tests and assessment of body composition by dual-energy X-ray absorptiometry. The LOW load consisted of a relative load at 15RM, whereas the MOD load consisted of a relative load at 10RM. Both groups presented significant changes from pre-training to post-training for chest press 1RM (LOW = 10.3%, and MOD = 11.1%), knee extension 1RM (LOW = 14.4%, and MOD = 16.6%), preacher curl 1RM (LOW = 12.4%, and MOD = 12.0%), fat-free mass (LOW = 2.1%, and MOD = 1.9%), body fat (LOW = -3.2%, and MOD = -2.7%), and MQI (LOW = 10.6%, and MOD = 11.3%). Results were similar (p > 0.05) between groups. These findings suggest that LOW and MOD loads are equally effective for promoting improvements in muscular strength and muscle growth as well as the MQI in older women.",2020,"Both groups presented significant changes from pre-training to post-training for chest press 1RM (LOW = 10.3%, and MOD = 11.1%), knee extension 1RM (LOW = 14.4%, and MOD = 16.6%), preacher curl 1RM (LOW = 12.4%, and MOD = 12.0%), fat-free mass (LOW = 2.1%, and MOD = 1.9%), body fat (LOW = -3.2%, and MOD = -2.7%), and MQI (LOW = 10.6%, and MOD = 11.3%).","['older women', 'Twenty-seven older women (71.5 ± 5 years, 65.2 ± 11 kg, 154.2 ± 5 cm, and 27.4 ± 4 kg·m', 'Older Women']","['Different Resistance Training Loads', 'J Strength Cond Res XX(X', 'resistance training loads', 'resistance training (RT']","['preacher curl 1RM', 'body fat', 'MQI', 'fat-free mass', 'knee extension 1RM', 'Muscle Quality Index', 'muscular strength, muscle mass, and muscle quality index (MQI', 'muscular strength and muscle growth', 'muscle quality index', '1-repetition maximum (1RM) tests and assessment of body composition by dual-energy X-ray absorptiometry']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5192328', 'cui_str': '27.4'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",27.0,0.0150862,"Both groups presented significant changes from pre-training to post-training for chest press 1RM (LOW = 10.3%, and MOD = 11.1%), knee extension 1RM (LOW = 14.4%, and MOD = 16.6%), preacher curl 1RM (LOW = 12.4%, and MOD = 12.0%), fat-free mass (LOW = 2.1%, and MOD = 1.9%), body fat (LOW = -3.2%, and MOD = -2.7%), and MQI (LOW = 10.6%, and MOD = 11.3%).","[{'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Paraná, Londrina, PR, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Picoloto', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Paraná, Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}, {'ForeName': 'Ewertton S', 'Initials': 'ES', 'LastName': 'Bezerra', 'Affiliation': 'Human Performance Laboratory, Federal University of Amazonas, Manaus, Brazil.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Health Sciences Department, CUNY Lehman College, Bronx, New York.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, PR, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003667'] 2198,32569112,The Effect of Evaluator Training on Inter- and Intrarater Reliability in High-Stakes Assessment in Simulation.,"AIM The aim of this study was to evaluate the effectiveness of a training intervention in achieving inter- and intrarater reliability among faculty raters conducting high-stakes assessment of clinical performance in simulation. BACKGROUND High-stakes assessment of simulation performance is being adopted in nursing education. However, limited research exists to guide best practices in training raters, which is essential to ensure fair and defensible assessment. METHOD A nationwide sample of 75 prelicensure RN program faculty participated in an experimental, randomized, controlled study. RESULTS Participants completing a training intervention achieved higher inter- and intrarater reliability than control group participants when using a checklist evaluation tool. Mixed results were achieved by participants when completing a global competency assessment. CONCLUSION The training intervention was effective in helping participants to achieve a shared mental model for use of a checklist, but more time may be necessary to achieve consistent global competence decisions.",2020,"RESULTS Participants completing a training intervention achieved higher inter- and intrarater reliability than control group participants when using a checklist evaluation tool.","['A nationwide sample of 75 prelicensure RN program faculty participated in an experimental, randomized, controlled study']","['Evaluator Training', 'training intervention']",['higher inter- and intrarater reliability'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0219438,"RESULTS Participants completing a training intervention achieved higher inter- and intrarater reliability than control group participants when using a checklist evaluation tool.","[{'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'About the Authors Ann E. Holland, PhD, RN, is a professor, Bethel University, St. Paul, Minnesota. Jone Tiffany, DNP, RN, CNE, CHSE, ANEF, is a professor, Bethel University. Linda Blazovich, DNP, RN, CNE, is an associate professor, St. Catherine University, St. Paul, Minnesota. Deborah Bambini, PhD, RN, WHNP-BC, CNE, CHSE, ANEF, is a professor, Grand Valley State University, Grand Rapids, Michigan. Vicki Schug, PhD, RN, CNE, is a professor, St. Catherine University. This study was supported by the National League for Nursing, with funding from Laerdal Medical. The authors acknowledge the work of their research assistant, Dorie Fritz, MSN, RN, and statistician, Joel Frederickson, PhD. For more information, contact Dr. Holland at ann-holland@bethel.edu.'}, {'ForeName': 'Jone', 'Initials': 'J', 'LastName': 'Tiffany', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Blazovich', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bambini', 'Affiliation': ''}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Schug', 'Affiliation': ''}]",Nursing education perspectives,['10.1097/01.NEP.0000000000000619'] 2199,32569125,"Effects of Multi-ingredient Preworkout Supplements on Physical Performance, Cognitive Performance, Mood State, and Hormone Concentrations in Recreationally Active Men and Women.","Beckner, ME, Pihoker, AA, Darnell, ME, Beals, K, Lovalekar, M, Proessl, F, Flanagan, SD, Arciero, PJ, Nindl, BC, and Martin, BJ. Effects of multi-ingredient preworkout supplements on physical performance, cognitive performance, mood state, and hormone concentrations in recreationally active men and women. J Strength Cond Res XX(X): 000-000, 2020-Performance enhancement supplement research has primarily focused on the effectiveness of individual ingredients, rather than the combination. This study investigated the acute effects of 2 multi-ingredient preworkout supplements (MIPS), with beta-alanine and caffeine (BAC) and without (NBAC), compared with placebo (PLA) on anaerobic performance, endurance capacity, mood state, cognitive function, vascular function, and anabolic hormones. Thirty exercise-trained individuals (24.4 ± 4.9 years, 15 men and 15 women) completed a fatiguing exercise protocol on 3 separate occasions, 30 minutes after ingestion of BAC, NBAC, or PLA. Outcomes were analyzed using one-way or two-way repeated-measures analysis of variance, as appropriate (alpha = 0.05). Anaerobic power was greater when supplementing with NBAC (10.7 ± 1.2 W·kg) and BAC (10.8 ± 1.4 W·kg) compared with PLA (10.4 ± 1.2 W·kg) (p = 0.014 and p = 0.022, respectively). BAC improved V[Combining Dot Above]O2peak time to exhaustion (p = 0.006), accompanied by an increase in blood lactate accumulation (p < 0.001), compared with PLA. Both NBAC and BAC demonstrated improved brachial artery diameter after workout (p = 0.041 and p = 0.005, respectively), but PLA did not. L-arginine concentrations increased from baseline to postsupplement consumption of BAC (p = 0.017). Reaction time significantly decreased after exercise for all supplements. There was no effect of supplement on mood states. Exercise-trained individuals looking to achieve modest improvements in power and endurance may benefit from consuming MIPS before exercise.",2020,"Both NBAC and BAC demonstrated improved brachial artery diameter after workout (p = 0.041 and p = 0.005, respectively), but PLA did not.","['Recreationally Active Men and Women', 'recreationally active men and women', 'Thirty exercise-trained individuals (24.4 ± 4.9 years, 15 men and 15 women']","['fatiguing exercise protocol', 'multi-ingredient preworkout supplements', 'Multi-ingredient Preworkout Supplements', 'placebo (PLA', '2 multi-ingredient preworkout supplements (MIPS), with beta-alanine and caffeine (BAC) and without (NBAC']","['brachial artery diameter', 'blood lactate accumulation', 'Anaerobic power', 'L-arginine concentrations', 'Reaction time', 'Physical Performance, Cognitive Performance, Mood State, and Hormone Concentrations', 'physical performance, cognitive performance, mood state, and hormone concentrations', 'mood states', 'BAC improved V[Combining', 'Beckner, ME, Pihoker, AA, Darnell, ME, Beals, K, Lovalekar, M, Proessl, F, Flanagan, SD, Arciero, PJ, Nindl, BC, and Martin, BJ', 'anaerobic performance, endurance capacity, mood state, cognitive function, vascular function, and anabolic hormones']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}]",,0.151182,"Both NBAC and BAC demonstrated improved brachial artery diameter after workout (p = 0.041 and p = 0.005, respectively), but PLA did not.","[{'ForeName': 'Meaghan E', 'Initials': 'ME', 'LastName': 'Beckner', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Alexis A', 'Initials': 'AA', 'LastName': 'Pihoker', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Darnell', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Beals', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mita', 'Initials': 'M', 'LastName': 'Lovalekar', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Proessl', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Flanagan', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Arciero', 'Affiliation': 'Health & Human Physiological Sciences Department, Skidmore College, Saratoga Springs, New York.'}, {'ForeName': 'Bradley C', 'Initials': 'BC', 'LastName': 'Nindl', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Martin', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Center, Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003660'] 2200,32569126,Effect of Caffeine on Endurance Performance in Athletes May Depend on HTR2A and CYP1A2 Genotypes.,"Guest, NS, Corey, P, Tyrrell, PN, and El-Sohemy, A. Effect of caffeine on endurance performance in athletes may depend on HTR2A and CYP1A2 genotypes. J Strength Cond Res XX(X): 000-000, 2020-This investigation determined whether variation in the HTR2A (serotonin receptor) gene modifies the ergogenic effects of caffeine on endurance and further modifies performance by the CYP1A2 genotype. Male athletes (n = 100; 25 ± 4 years) completed 10-km cycling time trials under 3 conditions as follows: 0, 2, or 4 mg of caffeine per kg body mass. Using a randomized, double-blinded, placebo-controlled design, data were analyzed using analysis of covariance to compare changes in cycling time between placebo (0 mg·kg) and each caffeine dose and adjusted for the placebo trial and order of treatment. A significance of ρ ≤ 0.05 was used. Subjects were genotyped for HTR2A (rs6313) and CYP1A2 (rs762551). A significant caffeine-HTR2A interaction (p = 0.003) was observed; however, after adjustment for placebo trials, the interaction was no longer significant (p = 0.37). Because of the strong caffeine-CYP1A2 interaction (p < 0.0001) previously reported in these subjects, where the 4-mg dose resulted in divergent effects (slower and faster) on the 10-km cycling time, we conducted a simplified model to examine these same factors by the HTR2A genotype. The post hoc analysis excluded HTR2A CT heterozygotes and 2-mg·kg caffeine trials. Among CYP1A2 fast metabolizers alone, a significant difference (1.7 minutes; p = 0.006) was observed when comparing (4- vs. 0-mg·kg caffeine trials) between the HTR2A CC (n = 16; 2.4 minutes) and TT (n = 7; 0.7 minutes) genotypes. Our results show that 4-mg·kg caffeine improves performance in individuals with the HTR2A CC genotype but only in those who are also CYP1A2 AA fast metabolizers. This study was registered with clinicaltrials.gov (NCT02109783).",2020,"Among CYP1A2 fast metabolizers alone, a significant difference (1.7 minutes; p = 0.006) was observed when comparing (4- vs. 0-mg·kg caffeine trials) between the HTR2A CC (n = 16; 2.4 minutes) and TT (n = 7; 0.7 minutes) genotypes.",['Male athletes (n = 100; 25 ± 4 years'],"['J Strength Cond Res XX(X', 'placebo', 'caffeine', 'Caffeine', '4-mg·kg caffeine', 'HTR2A CC']","['endurance performance', 'Endurance Performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}]",,0.355859,"Among CYP1A2 fast metabolizers alone, a significant difference (1.7 minutes; p = 0.006) was observed when comparing (4- vs. 0-mg·kg caffeine trials) between the HTR2A CC (n = 16; 2.4 minutes) and TT (n = 7; 0.7 minutes) genotypes.","[{'ForeName': 'Nanci S', 'Initials': 'NS', 'LastName': 'Guest', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Corey', 'Affiliation': 'Department of Statistical Sciences, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Pascal N', 'Initials': 'PN', 'LastName': 'Tyrrell', 'Affiliation': 'Department of Statistical Sciences, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Sohemy', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003665'] 2201,32569127,"Resistance Training Volume Enhances Muscle Hypertrophy, but Not Strength in Postmenopausal Women: A Randomized Controlled Trial.","Nascimento de Oliveira Júnior, G, de Freitas Rodrigues de Sousa, J, Augusto da Silva Carneiro, M, Martins, FM, Santagnello, SB, Campos Souza, MV, and Orsatti, FL. Resistance training volume enhances muscle hypertrophy, but not strength in postmenopausal women: a randomized controlled trial. J Strength Cond Res XX(X): 000-000, 2020-Among several possible resistance training (RT) variables to be manipulated, the training volume has been considered as a critical variable to maximize RT-induced hypertrophy. Many of the studies that compared one set of RT with 3 sets have failed to show a difference in muscle hypertrophy in older adults. However, it is not clear whether further increases in RT volume (i.e., 6 sets) would result in even greater RT-related hypertrophy than 3 sets in older adults. This study aimed to investigate whether higher-volume RT (HV-RT) maximizes gains in lean body mass and muscle strength (MS) when compared with lower-volume RT (LV-RT) in postmenopausal women (PW). Fifty-eight PW were randomized into 1 of the 3 groups: control group (CT, no exercise), HV-RT (6 sets per exercise), and LV-RT (3 sets per exercise). Volunteers took part in a supervised training program (leg press 45°, leg extension, leg curl and standing calf raises) and were assessed for leg lean mass (LLM; dual X-ray absorptiometry) and lower limb MS (leg press and leg extension; 1 repetition maximum [1RM]) before and after 12 weeks of RT. Both HV-RT and LV-RT groups increased (p < 0.05) LLM and MS when compared with the CT group. Higher increases in LLM gains were observed for the HV-RT group when compared with the LV-RT group (6.1 and 2.3%, p < 0.001). Both HV-RT and LV-RT groups similarly increased 1RM in the leg press and leg extension. Thus, there seems to be a dose-response relationship between RT volume and muscle hypertrophy, but not for MS gains in PW.",2020,Both HV-RT and LV-RT groups increased (p < 0.05),"['older adults', 'Postmenopausal Women', 'postmenopausal women (PW', 'postmenopausal women', 'Fifty-eight PW']","['HV-RT and LV-RT', 'supervised training program (leg press 45°, leg extension, leg curl and standing calf raises', 'LV-RT', 'CT', 'Resistance Training Volume', 'control group (CT, no exercise), HV-RT (6 sets per exercise), and LV-RT', 'higher-volume RT (HV-RT) maximizes gains', 'lower-volume RT (LV-RT', 'Resistance training volume']","['LLM and MS', '1RM', 'LLM gains', 'RT volume', 'lean body mass and muscle strength (MS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}]",58.0,0.0147849,Both HV-RT and LV-RT groups increased (p < 0.05),"[{'ForeName': 'Gersiel', 'Initials': 'G', 'LastName': 'Nascimento de Oliveira-Júnior', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Jairo de Freitas Rodrigues', 'Initials': 'JFR', 'LastName': 'de Sousa', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Marcelo Augusto da Silva', 'Initials': 'MADS', 'LastName': 'Carneiro', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Martins', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Samarita Beraldo', 'Initials': 'SB', 'LastName': 'Santagnello', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Markus Vinicius Campos', 'Initials': 'MVC', 'LastName': 'Souza', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Fábio Lera', 'Initials': 'FL', 'LastName': 'Orsatti', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003601'] 2202,32569128,Examining the Influence of Attentional Focus on the Effects of a Neuromuscular Training Program in Male Athletes.,"Ghanati, HA, Letafatkar, A, Almonroeder, TG, and Rabiei, P. Examining the influence of attentional focus on the effects of a neuromuscular training program in male athletes. J Strength Cond Res XX(X): 000-000, 2020-Neuromuscular training programs that incorporate lower extremity strengthening, plyometric exercises, balance training, and movement retraining are recommended for anterior cruciate ligament injury prevention; however, there is a need to improve their effectiveness. The purpose of this study was to examine how athletes' attentional focus during training influences the effects of an 8-week neuromuscular training program on hip strength, single-leg landing mechanics, and hop performance. Sixty-six male athletes were randomly allocated to a group that trained with an internal focus, a group that trained with an external focus, or a control group. All athletes completed testing before (baseline) and after (posttesting) the 8-week period. Isokinetic hip strength, hip and knee kinematics and ground reaction forces during landing, and hop distance were examined as part of this study. Analysis of covariance was used to compare posttesting outcomes among the groups while accounting for group differences in baseline performance. The neuromuscular training program resulted in improved hip abduction strength, reduced hip adduction and internal rotation motion during landing, and increased hop distance for athletes who trained with an external focus. However, the program did not seem to influence hip strength, landing kinematics, or hop performance for athletes who trained with an internal focus. Our findings indicate that male athletes may benefit from completing a neuromuscular training program with an external focus vs. an internal focus. Trainers, coaches, and clinicians should consider using instructions that promote an external focus when implementing neuromuscular training programs with male athletes.",2020,"The neuromuscular training program resulted in improved hip abduction strength, reduced hip adduction and internal rotation motion during landing, and increased hop distance for athletes who trained with an external focus.","['male athletes', 'Male Athletes', 'Sixty-six male athletes']","['Neuromuscular Training Program', 'J Strength Cond Res XX(X', '2020-Neuromuscular training programs that incorporate lower extremity strengthening, plyometric exercises, balance training, and movement retraining', 'neuromuscular training program']","['Isokinetic hip strength, hip and knee kinematics and ground reaction forces', 'hip strength, landing kinematics', 'hip strength, single-leg landing mechanics', 'hip abduction strength, reduced hip adduction and internal rotation motion during landing, and increased hop distance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",66.0,0.0111813,"The neuromuscular training program resulted in improved hip abduction strength, reduced hip adduction and internal rotation motion during landing, and increased hop distance for athletes who trained with an external focus.","[{'ForeName': 'Hadi Abbaszadeh', 'Initials': 'HA', 'LastName': 'Ghanati', 'Affiliation': 'Department of Sport Injury and Corrective Exercise, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Department of Sport Injury and Corrective Exercise, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'Department of Health Professions, University of Wisconsin-La Crosse, La Crosse, Wisconsin.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Rabiei', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Vrije Universiteit Brussel, Brussels, Belgium.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003681'] 2203,32569130,"Effect of Traditional, Cluster, and Rest Redistribution Set Configurations on Neuromuscular and Perceptual Responses During Strength-Oriented Resistance Training.","Cuevas-Aburto, J, Jukic, I, Chirosa-Ríos, LJ, González-Hernández, JM, Janicijevic, D, Barboza-González, P, Guede-Rojas, F, and García-Ramos, A. Effect of traditional, cluster, and rest redistribution set configurations on neuromuscular and perceptual responses during strength-oriented resistance training. J Strength Cond Res XX(X): 000-000, 2020-This study aimed to compare the acute effect of traditional (TR), cluster (CL), and rest redistribution (RR) set configurations on neuromuscular and perceptual measures of fatigue. Thirty-one resistance-trained men randomly performed a Control session and 3 experimental sessions consisting of the squat (SQ) and bench press (BP) exercises performed against the 10 repetition maximum load using TR (3 sets of 6 repetitions; 3 minutes of interset rest), CL (3 sets of 6 repetitions; 30 seconds of intraset rest every 2 repetitions; 3 minutes of interset rest), and RR (9 sets of 2 repetitions; 45 seconds of interset rest) set configurations. A significant effect of ""set configuration"" (p = 0.002) was observed for barbell velocity. The average velocity of the training session was lower for TR compared with CL (% difference = 5.09% in SQ and 5.68% in BP) and RR (% difference = 5.92% in SQ and 2.71% in BP). The 3 set configurations induced comparable decrements in countermovement jump height (% difference from -6.0% to -8.1%) and throwing velocity (% difference from -0.6% to -1.2%). Ratings of perceived exertion (RPE-10) values collected after the sets were higher for TR (SQ: 6.9 ± 0.7 a.u.; BP: 6.8 ± 0.8 a.u.) compared with CL (SQ: 6.2 ± 0.8 a.u.; BP: 6.4 ± 0.7 a.u.) and RR (SQ: 6.2 ± 0.8 a.u.; BP: 6.6 ± 0.9 a.u.), while the session RPE did not differ between the set configurations (p = 0.595). CL and RR set configurations allow for higher velocities and lower RPE values during resistance training sessions not performed to failure in comparison with a TR set configuration.",2020,CL and RR set configurations allow for higher velocities and lower RPE values during resistance training sessions not performed to failure in comparison with a TR set configuration.,['Thirty-one resistance-trained men randomly performed a'],"['J Strength Cond Res XX(X', 'Control session and 3 experimental sessions consisting of the squat (SQ) and bench press (BP) exercises performed against the 10 repetition maximum load using TR', 'Traditional, Cluster, and Rest Redistribution Set Configurations']","['Neuromuscular and Perceptual Responses', 'average velocity of the training session', 'countermovement jump height', 'acute effect of traditional (TR), cluster (CL), and rest redistribution (RR) set configurations on neuromuscular and perceptual measures of fatigue', 'throwing velocity', 'Ratings of perceived exertion (RPE-10) values', 'RPE values']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0413955,CL and RR set configurations allow for higher velocities and lower RPE values during resistance training sessions not performed to failure in comparison with a TR set configuration.,"[{'ForeName': 'Jesualdo', 'Initials': 'J', 'LastName': 'Cuevas-Aburto', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, University of the Most Holy Conception, Concepción, Chile.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Jukic', 'Affiliation': 'Sport Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Luis Javier', 'Initials': 'LJ', 'LastName': 'Chirosa-Ríos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jorge Miguel', 'Initials': 'JM', 'LastName': 'González-Hernández', 'Affiliation': 'Faculty of Health Science, European University of the Canary Islands, Tenerife, Spain.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': 'University of Belgrade, Faculty of Sport and Physical Education, the Research Center, Belgrade, Serbia.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Barboza-González', 'Affiliation': 'Faculty of Education, Andres Bello University, Concepción, Chile.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Guede-Rojas', 'Affiliation': 'Faculty of Rehabilitation Sciences, Kinesiology, Universidad Andres Bello, Concepción, Chile.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, University of the Most Holy Conception, Concepción, Chile.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003658'] 2204,32569164,Evaluation of clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of acute respiratory distress syndrome.,"INTRODUCTION Acute respiratory distress syndrome (ARDS) is a common disease in critically ill patients that has a high incidence and mortality rate worldwide. At present, there is no specific treatment for ARDS. Traditional Chinese medicine has been shown to have good potential in preventing and treating ARDS, especially in reducing the dosages of Western medicines and therefore, adverse drug reactions. The purpose of this study is to compare the clinical efficacy of integrated Chinese and Western medicine to that of Western medicine alone in the treatment of ARDS. METHODS We are proposing a prospective, multicenter, randomized, double-blind, placebo-controlled study in which 110 eligible patients would be enrolled and randomly divided into a Western medicine treatment group and an integrated Chinese and Western medicine treatment group. After 2 weeks of interventions and 1 year of follow-up, the clinical efficacy and safety of Jiawei qianyang dan in ARDS patients would be observed. The outcomes measured would include the Traditional Chinese medicine symptom score, the oxygenation index (PɑO2/FiO2), extravascular pulmonary water index, duration of mechanical ventilation, number of ICU hospitalization days, and the 28-day mortality rate for the 2 groups before and after treatment. The all-cause mortality rate, respiratory failure mortality rate, and readmission rate after 1 year of follow-up will be statistically analyzed and safety will be evaluated. DISCUSSION In this study, we aim to demonstrate the greater clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of ARDS compared to that of Western medicine alone. In order to do this, we hope to provide evidence for the clinically supportive effect of the Jiawei qianyang dan in the treatment of ARDS and therefore demonstrate a more effective treatment.",2020,"The all-cause mortality rate, respiratory failure mortality rate, and readmission rate after 1 year of follow-up will be statistically analyzed and safety will be evaluated. ","['acute respiratory distress syndrome', '110 eligible patients']","['placebo', 'integrated traditional Chinese and Western medicine', 'Western medicine treatment group and an integrated Chinese and Western medicine treatment group', 'integrated Chinese and Western medicine']","['mortality rate, respiratory failure mortality rate, and readmission rate', 'Traditional Chinese medicine symptom score, the oxygenation index (PɑO2/FiO2), extravascular pulmonary water index, duration of mechanical ventilation, number of ICU hospitalization days, and the 28-day mortality rate']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",110.0,0.042412,"The all-cause mortality rate, respiratory failure mortality rate, and readmission rate after 1 year of follow-up will be statistically analyzed and safety will be evaluated. ","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Kunlan', 'Initials': 'K', 'LastName': 'Long', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Peiyang', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Chuantao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Ding', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",Medicine,['10.1097/MD.0000000000020341'] 2205,32563787,Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis.,"OBJECTIVES The role of topical anti-infectives in acute exacerbations of chronic rhinosinusitis is controversial. Povidone-iodine is an anti-bacterial and anti-viral that is affordable and available over-the-counter and may demonstrate advantages over mupirocin as a sinus irrigation therapy. The objective was to compare povidone-iodine or mupirocin versus saline sinus irrigations for sinusitis exacerbations in post-surgery subjects as well as to assess tolerability of povidone-iodine sinus irrigations. MATERIALS AND METHODS This was a prospective single-blinded (clinician only) randomized controlled trial. Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture. They received povidone-iodine, mupirocin, or saline sinus irrigations, twice daily for 30 days. Outcomes were post-treatment culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary). RESULTS Of the 62 subjects analyzed, post-treatment culture negativity rate was higher in the MUP (14/20, 70%) group compared to the PI (9/21, 43%) and SAL (9/19, 47%) groups, although this was not significant (p = 0.29). Povidone-iodine sinus irrigations at the 1% concentration were very well-tolerated, similar to saline irrigations. There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3 [-0.7, 0.05] vs. saline -0.4 [-0.8, 0.05]; p = 0.86) or Lund-Kennedy endoscopic score (povidone-iodine -3.5 [-7, -0.5] vs. mupirocin -2 [-4, 2] vs. saline -3 [-5, 0]; p = 0.45) change. No serious adverse effects were reported. CONCLUSIONS In patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations achieved a better post-treatment culture ""control"" rate compared to saline and povidone-iodine. In addition, 1% povidone-iodine solution was well-tolerated as a sinus irrigation and may represent a feasible method for temporarily disinfecting the sinonasal cavity of bacteria and viruses such as COVID-19.",2020,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","['patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations', 'sinusitis exacerbations in post-surgery subjects', 'chronic rhinosinusitis', '62 subjects analyzed', 'Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture']","['povidone-iodine, mupirocin, or saline sinus irrigations', 'Povidone-iodine sinus irrigations', 'saline -3', 'povidone-iodine solution', 'saline and povidone-iodine', 'Povidone-iodine', 'povidone-iodine or mupirocin versus saline sinus irrigations', 'topical anti-infectives']","['Lund-Kennedy endoscopic score', 'Tolerability and effectiveness', 'Sinonasal Outcome Test-20 score', 'culture negativity rate', 'culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018154', 'cui_str': 'Gram-positive bacteria'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5197691', 'cui_str': 'SNOT-20'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.208361,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","[{'ForeName': 'Victoria S', 'Initials': 'VS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America. Electronic address: vlee39@uic.edu.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Pottinger', 'Affiliation': 'Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington, 1959 NE Pacific St, PO Box 356130, Courier BB-302, Seattle, WA 98195, United States of America.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Davis', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102604'] 2206,32563846,Depression history as a predictor of outcomes during buprenorphine-naloxone treatment of prescription opioid use disorder.,"BACKGROUND In the multi-site Prescription Opioid Addiction Treatment Study (POATS), the best predictor of successful opioid use outcome was lifetime diagnosis of major depressive disorder. The primary aim of this secondary analysis of data from POATS was to empirically assess two explanations for this counterintuitive finding. METHODS The POATS study was a national, 10-site randomized controlled trial (N = 360 enrolled in the 12-week buprenorphine-naloxone maintenance treatment phase) sponsored by the NIDA Clinical Trials Network. We evaluated how the presence of a history of depression influences opioid use outcome (negative urine drug assays). Using adjusted logistic regression models, we tested the hypotheses that 1) a reduction in depressive symptoms and 2) greater motivation and engagement in treatment account for the association between depression history and good treatment outcome. RESULTS Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns). Reporting a goal of opioid abstinence at treatment entry was also not associated with outcomes (aOR = 1.39, ns); however, mutual-help group participation was associated with good treatment outcomes (aOR = 1.67, p <.05). In each of these models, lifetime major depressive disorder remained associated with good outcomes (aORs = 1.63-1.82, ps = .01-.055). CONCLUSIONS Findings are consistent with the premise that greater engagement in treatment is associated with good opioid outcomes. Nevertheless, depression history continues to be associated with good opioid outcomes in adjusted models. More research is needed to understand how these factors could improve treatment outcomes for those with opioid use disorder.",2020,"Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns).","['prescription opioid use disorder', '360 enrolled in the 12-week', 'maintenance treatment phase) sponsored by the NIDA Clinical Trials Network']",['buprenorphine-naloxone'],"['lifetime major depressive disorder', 'depressive symptoms']","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0068218', 'cui_str': 'N-nitrosoiminodiacetic acid'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",360.0,0.0809725,"Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns).","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Peckham', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA. Electronic address: adpeckham@mclean.harvard.edu.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Griffin', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108122'] 2207,32563847,Longitudinal analysis of alcohol use and intimate partner violence perpetration among men with HIV in northern Vietnam.,"BACKGROUND Alcohol use is a known risk factor for male-perpetrated intimate partner violence (IPV), although few studies have been conducted globally and among men with HIV (MWH). We estimated the longitudinal effects of alcohol use on IPV perpetration among MWH. METHODS This study is a secondary analysis of randomized controlled trial data among male and female antiretroviral treatment patients with hazardous alcohol use in Thai Nguyen, Vietnam. Analyses were restricted to male participants who were married/cohabitating (N = 313). Alcohol use was assessed as proportion days alcohol abstinent, heavy drinking, and alcohol use disorder (AUD) using the Timeline Followback and Mini International Neuropsychiatric Interview questionnaire. Multilevel modeling was used to estimate the effects of higher versus lower average alcohol use on IPV perpetration (between-person effects) and the effects of time-specific deviations in alcohol use on IPV perpetration (within-person effects). RESULTS Participants with higher average proportion days alcohol abstinent had decreased odds of IPV perpetration (adjusted Odds Ratio [aOR] = 0.43, p = 0.03) and those with higher average heavy drinking and AUD had increased odds of IPV perpetration (Heavy drinking: aOR = 1.05, p = 0.002; AUD: aOR = 4.74, p < 0.0001). Time-specific increases in proportion days alcohol abstinent were associated with decreased odds of IPV perpetration (aOR = 0.39, p = 0.02) and time-specific increases in AUD were associated with increased odds of IPV perpetration (aOR = 2.95, p = 0.001). Within-person effects for heavy drinking were non-significant. CONCLUSIONS Alcohol use is associated with IPV perpetration among Vietnamese men with HIV. In this context, AUD and frequent drinking are stronger correlates of IPV perpetration as compared to heavy drinking.",2020,"Within-person effects for heavy drinking were non-significant. CONCLUSIONS Alcohol use is associated with IPV perpetration among Vietnamese men with HIV.","['men with HIV in northern Vietnam', 'men with HIV (MWH', 'Vietnamese men with HIV', 'male participants who were married/cohabitating (N = 313', 'male and female antiretroviral treatment patients with hazardous alcohol use in Thai Nguyen, Vietnam', 'male-perpetrated intimate partner violence (IPV']",[],"['proportion days alcohol abstinent, heavy drinking, and alcohol use disorder (AUD) using the Timeline Followback and Mini International Neuropsychiatric Interview questionnaire', 'time-specific increases in AUD', 'Time-specific increases in proportion days alcohol abstinent', 'IPV perpetration']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",313.0,0.0196213,"Within-person effects for heavy drinking were non-significant. CONCLUSIONS Alcohol use is associated with IPV perpetration among Vietnamese men with HIV.","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA. Electronic address: rhershow@live.unc.edu.'}, {'ForeName': 'H Luz McNaughton', 'Initials': 'HLM', 'LastName': 'Reyes', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'UNC Project Vietnam, Yen Hoa Health Clinic, Lot E2, Duong Dinh Nghe Street, Hanoi, Viet Nam.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Nguyen Vu Tuyet', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'UNC Project Vietnam, Yen Hoa Health Clinic, Lot E2, Duong Dinh Nghe Street, Hanoi, Viet Nam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108098'] 2208,32563858,Capitalizing on cross-language similarities in intervention with bilingual children.,"PURPOSE This study examined the effects of a vocabulary intervention for bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates. We measured effects in terms of change from pre- to post-intervention in Spanish as well as associations with the non-target language, English. METHOD Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder. Children completed the intervention in pairs (one child with DLD and a typically developing peer) for 70-minute sessions, 3 days a week, for four weeks. Intervention targeted 32 words (16 cognates, 16 non-cognates) using four storybooks (8 words/book) and interactive activities that highlighted similarities across languages. Pre- and post-intervention measures in Spanish and English included tasks of word definition and cognate facilitation. RESULTS As a group, children showed improvement in definition quality and cognate naming in Spanish. There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD. All children showed positive cross-language correlations on post-intervention measures. CONCLUSIONS Bilingual children, with and without DLD, have the capacity to improve in their awareness and use of cognates. Explicit teaching of cognates can be an effective tool for building vocabulary skills. Children with DLD may need additional time and support to apply their knowledge of cognates to vocabulary learning.",2020,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[""bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates"", 'Children with DLD', 'Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder', 'Spanish and English']",['vocabulary intervention'],"['included tasks of word definition and cognate facilitation', 'definition quality and cognate naming', 'positive cross-language correlations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0437372,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[{'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Dam', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States; University of California San Diego, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: qdam@sdsu.edu.'}, {'ForeName': 'Giang T', 'Initials': 'GT', 'LastName': 'Pham', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: gpham@sdsu.edu.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Pruitt-Lord', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: spruitt@sdsu.edu.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Limon-Hernandez', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: jlimon-hernandez@sdsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Goodwiler', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: cgoodwiler@sdsu.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106004'] 2209,32564051,Treatment of Temporomandibular Joint Disorders by Ultrashort Wave and Extracorporeal Shock Wave: A Comparative Study.,"BACKGROUND This study was carried out to compare the therapeutic efficacy of extracorporeal shock wave (ESW) and ultrashort wave (UW) for temporomandibular joint disorder (TMD). MATERIAL AND METHODS A total of 80 patients with myofascial pain and TMD were enrolled in this study. The subjects were randomized to receive ESW or UW treatments. Patients in the ESW group received 1 ESW treatment for 4 weeks and patients in the US group were given US treatment once a day for 5 days per week for 4 weeks. The pain was measured using visual analog scale (VAS) and mouth opening was determined as pain-free maximum mouth opening (MMO) before and 4 weeks after the treatments. Other parameters assessed included functional indexes of temporomandibular joint such as mandibular movement (MM), joint noise (JN), joint press (JP), and disability index (DI). RESULTS After therapy, VAS, MMO, MM, JN, JP, and DI in ESW group, and VAS in UW group were significantly improved (P<0.05) as compared to before therapy. VAS, MMO, and the functional indexes of temporomandibular joint in the ESW group were significantly better than those in the UW group (1.79 vs. 2.00, 3.23 vs. 2.03, 1.79 vs. 2.41, 1.45 vs. 2.27, 1.55 vs. 2.59, and 3.30 vs. 4.79, respectively. P<0.05). CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.",2020,CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.,"['temporomandibular joint disorder (TMD', '80 patients with myofascial pain and TMD']","['extracorporeal shock wave (ESW) and ultrashort wave (UW', 'ESW', 'Ultrashort Wave and Extracorporeal Shock Wave']","['VAS, MMO, MM, JN, JP, and DI', 'functional indexes of temporomandibular joint such as mandibular movement (MM), joint noise (JN), joint press (JP), and disability index (DI', 'visual analog scale (VAS) and mouth opening was determined as pain-free maximum mouth opening (MMO', 'pain', 'functional indexes of temporomandibular joint and mouth opening limit', 'VAS, MMO, and the functional indexes of temporomandibular joint']","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0277829', 'cui_str': 'Noises in joint'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",80.0,0.0591111,CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.,"[{'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China (mainland).'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923461'] 2210,32564058,Pregnancy outcomes of women conceiving on antiretroviral therapy (ART) compared to those commenced on ART during pregnancy.,"BACKGROUND Globally, the number of HIV-infected women of child-bearing age conceiving on ART is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The PROMISE 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies. METHODS The PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of non-breastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who re-started ART after pregnancy was diagnosed. RESULTS Pregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up. CONCLUSIONS We found an increased risk for adverse pregnancy outcomes in women conceiving on ART emphasising the need for improved obstetric and neonatal care for this group.",2020,"The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up. ",['939 subsequent pregnancies of 826 mothers'],"['discontinue ART', 'women conceiving on antiretroviral therapy (ART']","['incidence of low birth weight', 'risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio']","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",826.0,0.235655,"The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up. ","[{'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Brummel', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Pinilla', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'MUJHU Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'UNC Project-Malawi CRS; University of North Carolina at Chapel Hill, Department of Obstetrics and Gynaecology, Division of Global Women Health, Lilongwe, Malawi.'}, {'ForeName': 'Bonus', 'Initials': 'B', 'LastName': 'Makanani', 'Affiliation': 'College of Medicine-Johns Hopkins Research Project, Blantyre, Malawi.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases , David Geffer School of Medicine at the University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Johns Hopkins University, Department of Pathology, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa805'] 2211,32564066,Does the impact of intensive lifestyle intervention on cardiovascular disease vary according to frailty measured via deficit accumulation?,"BACKGROUND Individuals are often counseled to use behavioral weight loss strategies to reduce risk for cardiovascular disease (CVD). We examined whether any benefits for CVD risk from weight loss intervention extend uniformly to individuals across a range of underlying health states. METHODS The time until first occurrence of a composite of fatal and non-fatal myocardial infarction and stroke, hospitalized angina, or CVD death was analyzed from 8-11 years of follow-up of 4,859 adults who were overweight or obese, aged 45-76 years with type 2 diabetes. Individuals had been randomly assigned to either an intensive lifestyle intervention (ILI) or diabetes support and education (DSE). Participants were grouped by intervention assignment and a frailty index (FI) based on deficit accumulation, ordered from fewer (first tertile) to more (third tertile) deficits. RESULTS Baseline FI scores were unrelated to intervention-induced weight losses and increased physical activity. The relative effectiveness of ILI on CVD incidence was inversely related to baseline FI in a graded fashion (p=0.01), with relative benefit (hazard ratio=0.73 [95% CI 0.55,0.98]) for individuals in the first FI tertile to no benefit (hazard ratio=1.15 [0.94,1.42]) among those in the third FI tertile. This graded relationship was not seen for individuals ordered by age tertile (p=0.52), and was stronger among participants aged 45-59 years (3-way interaction p=0.04). CONCLUSIONS In overweight/obese adults with diabetes, multidomain lifestyle interventions may be most effective in reducing CVD if administered before individuals have accrued many age-related health deficits. However, these exploratory analyses require confirmation by other studies.",2020,"The relative effectiveness of ILI on CVD incidence was inversely related to baseline FI in a graded fashion (p=0.01), with relative benefit (hazard ratio=0.73 [95% CI 0.55,0.98]) for individuals in the first FI tertile to no benefit (hazard ratio=1.15 [0.94,1.42]) among those in the third FI tertile.","['4,859 adults who were overweight or obese, aged 45-76 years with type 2 diabetes']","['intensive lifestyle intervention (ILI) or diabetes support and education (DSE', 'intensive lifestyle intervention']","['CVD incidence', 'weight losses and increased physical activity', 'time until first occurrence of a composite of fatal and non-fatal myocardial infarction and stroke, hospitalized angina, or CVD death']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4859.0,0.0677888,"The relative effectiveness of ILI on CVD incidence was inversely related to baseline FI in a graded fashion (p=0.01), with relative benefit (hazard ratio=0.73 [95% CI 0.55,0.98]) for individuals in the first FI tertile to no benefit (hazard ratio=1.15 [0.94,1.42]) among those in the third FI tertile.","[{'ForeName': 'Felicia R', 'Initials': 'FR', 'LastName': 'Simpson', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, Martin Luther King Jr. Drive, Winston-Salem, NC.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science One Medical Center Blvd, Winston-Salem, NC.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kritchevsky', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'McCaffery', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC.""}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital Medical School, Providence, RI.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ingram', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, Martin Luther King Jr. Drive, Winston-Salem, NC.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ojeranti', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, Martin Luther King Jr. Drive, Winston-Salem, NC.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science One Medical Center Blvd, Winston-Salem, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa153'] 2212,32564076,A randomized controlled trial of isoniazid to prevent Mycobacterium tuberculosis infection in Kenyan HIV-exposed uninfected infants.,"BACKGROUND HIV-exposed uninfected (HEU) infants in endemic settings are at high risk of tuberculosis (TB). For infants, progression from primary M. tuberculosis infection to TB disease can be rapid. We assessed whether isoniazid (INH) prevents primary Mtb infection. METHODS We conducted a randomized non-blinded controlled trial enrolling HEU infants 6 weeks of age without known TB exposure in Kenya. Participants were randomized (1:1) to 12 months daily INH (10 mg/kg) vs. no INH. Primary endpoint was Mtb infection at end of 12 months, assessed by interferon-gamma release assay QuantiFERON-TB Gold Plus (QFT-Plus) and/or tuberculin skin test (TST, added 6 months after first participant exit). RESULTS Between August 15, 2016 and June 6, 2018, 416 infants were screened, with 300 (72%) randomized to INH or no INH (150 per arm); 2 were excluded due to HIV infection. Among 298 randomized HEU infants, 12-month retention was 96.3% (287/298) and 88.9% (265/298) had primary outcome data. Mtb infection prevalence at 12-months follow-up was 10.6% (28/265); 7.6% (10/132) in INH and 13.5% (18/133) in no INH arms (7.0 vs. 13.4 per 100PY, HR 0.53 [95%CI 0.24-1.14], p=0.11]), and driven primarily by TST positivity (8.6% [8/93] in INH and 18.1% [17/94] in no INH arms; RR 0.48 [95%CI 0.22-1.05], p=0.07). Frequency of severe adverse events was similar between arms (INH 14.0% [21/150] vs. no INH 10.7% [16/150], p=0.38), with no INH-related adverse events. CONCLUSIONS Further studies evaluating TB preventive therapy to prevent or delay primary Mtb infection in HEU and other high-risk infants are warranted.",2020,"Frequency of severe adverse events was similar between arms (INH 14.0% [21/150] vs. no INH 10.7% [16/150], p=0.38), with no INH-related adverse events. ","['Between August 15, 2016 and June 6, 2018, 416 infants were screened, with 300 (72%) randomized to INH or no INH (150 per arm); 2 were excluded due to HIV infection', 'HEU infants 6 weeks of age without known TB exposure in Kenya', 'Kenyan HIV-exposed uninfected infants']","['isoniazid (INH', 'isoniazid']","['12-month retention', 'Frequency of severe adverse events', 'Mycobacterium tuberculosis infection', 'TST positivity', 'Mtb infection at end of 12 months, assessed by interferon-gamma release assay QuantiFERON-TB Gold Plus (QFT-Plus) and/or tuberculin skin test (TST, added 6 months after first participant exit', 'Mtb infection prevalence']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0149796', 'cui_str': 'Exposure to tuberculosis'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",416.0,0.474773,"Frequency of severe adverse events was similar between arms (INH 14.0% [21/150] vs. no INH 10.7% [16/150], p=0.38), with no INH-related adverse events. ","[{'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'LaCourse', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Warr', 'Affiliation': 'Department of Pediatrics, Department of Medicine, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maleche-Obimbo', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matemo', 'Affiliation': 'Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Cranmer', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jerphason', 'Initials': 'J', 'LastName': 'Mecha', 'Affiliation': 'Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jaclyn N', 'Initials': 'JN', 'LastName': 'Escudero', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Hawn', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa827'] 2213,32564093,"Effects of progesterone therapy on serum sclerostin levels in healthy menopausal women: a 3-month randomized, placebo-controlled clinical trial.","Sclerostin, a natural hormone made in bone, suppresses bone formation. Sclerostin is also decreased by estrogen. Progesterone, estrogen's menstrual partner, stimulates bone formation. It is unclear whether progesterone influences sclerostin. This study showed that progesterone did not change sclerostin using serum remaining from a randomized progesterone hot flush therapy trial. INTRODUCTION Progesterone and sclerostin are both endogenous hormones acting through osteoblast-origin cells and promote or suppress bone formation, respectively. Estradiol suppresses sclerostin, but progesterone, its menstrual cycle partner hormone, has unclear sclerostin relationships. We postulated that progesterone therapy would influence serum sclerostin levels. METHODS We obtained sclerostin levels for an ethics-approved post hoc analysis. Fasting sclerostin was measured in all remaining sera from a previous 12-week randomized controlled trial (RCT) of oral micronized progesterone (progesterone) for menopausal (> 1 year after last flow) vasomotor symptoms (VMS). Women in the RCT took 300 mg progesterone at bedtime or placebo (1:1) in a trial showing progesterone significantly decreased VMS. RESULTS Participants were healthy menopausal, primarily Caucasian (91.2%) community-dwelling women (± SD), 55.2 ± 4.6 years old with BMI 24.9 ± 2.9 kg/m 2 . The baseline sclerostin level in 60 women was 28.41 ± 10.47 pmol/L. Baseline sclerostin was not correlated with the run-in VMS score (r = 0.143, P = 0.294). Paired baseline and 12-week RCT data for 52 women showed serum sclerostin levels did not change related to experimental therapy (P = 0.504). Changes in final sclerostin values adjusted for baseline were progesterone (- 1.07 ± 7.96 pmol/L) and placebo (- 2.64 ± 8.70 pmol/L). In observational data (n = 60), baseline sclerostin levels correlated with the General Framingham Cardiovascular (CVD) Risk score (r = - 0.398, P = 0.003) and self-reported health by SF-36 quality of life instrument (QoL, r = - 0.331, P = 0.016). CONCLUSION Physiological oral micronized progesterone did not stimulate nor suppress serum sclerostin levels based on post hoc analysis of RCT data. Exploratory results, however, showed sclerostin negatively correlated with CVD risk and QoL. ClinicalTrials.gov #NCT0146469.",2020,Physiological oral micronized progesterone did not stimulate nor suppress serum sclerostin levels based on post hoc analysis of RCT data.,"['Participants were healthy menopausal, primarily Caucasian (91.2%) community-dwelling women (±\u2009SD), 55.2\u2009±\u20094.6\xa0years old with BMI 24.9\u2009±\u20092.9\xa0kg/m 2 ', 'healthy menopausal women']","['oral micronized progesterone (progesterone', 'progesterone', 'progesterone therapy', 'Physiological oral micronized progesterone', 'placebo']","['baseline sclerostin levels', 'final sclerostin values', 'General Framingham Cardiovascular (CVD) Risk score', 'Fasting sclerostin', 'serum sclerostin levels', ""Progesterone, estrogen's menstrual partner, stimulates bone formation"", 'baseline sclerostin level', 'VMS']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.0755792,Physiological oral micronized progesterone did not stimulate nor suppress serum sclerostin levels based on post hoc analysis of RCT data.,"[{'ForeName': 'Y B', 'Initials': 'YB', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goshtasebi', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'van Lierop', 'Affiliation': 'Center for Bone Quality, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kalidasan', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hitchcock', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Prior', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), University of British Columbia, Vancouver, British Columbia, Canada. Jerilynn.prior@ubc.ca.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05505-x'] 2214,32564128,A randomized phase II trial of cisplatin plus gemcitabine versus carboplatin plus gemcitabine in patients with completely resected non-small cell lung cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT0703).,"PURPOSE This study evaluated the efficacy and safety of platinum plus gemcitabine (P/G) combinations as postoperative adjuvant chemotherapies for non-small cell lung cancer. METHODS Patients with postoperative stage IB-IIIA non-small cell lung cancer were randomly assigned to receive either cisplatin plus gemcitabine (GP arm) or carboplatin plus gemcitabine (GC arm) every 3 weeks for four cycles. The primary endpoint was 2-year disease-free survival (DFS). Secondary endpoints were safety, feasibility, overall survival (OS), and biomarker analyses. RESULTS A total of 102 patients were randomized (stage IB, 22%; II, 36%; IIIA, 42%; histology: 74% adenocarcinoma). Of the 51 patients in each arm, 37 (73%) completed 4 cycles. During follow-up (median 5.8 years; range 0.1-9.7 years), estimated DFS and OS rates at 2 years were 59.6% and 86.3% with GP and 68.0% and 86.3% with GC, respectively. No significant difference in DFS was noted between arms (P = 0.163), although 3-, 4-, and 5-year DFS rates were higher with GC. Hematological toxic effects were comparable and non-hematological toxic effects were infrequent. DFS was significantly higher in the excision repair cross-complementation group 1 (ERCC1)-low group than in the ERCC1-high group for the GP arm (P = 0.045). CONCLUSION Both P/G combination regimens were feasible and well-tolerated, and thus may represent valid options for postoperative adjuvant treatment of non-small cell lung cancer. Although no significant differences in DFS were evident between regimens, the present data favor the adoption of GC for further evaluation. CLINICAL TRIAL REGISTRATION UMIN-CTR (https://www.umin.ac.jp/ctr/) identifier: UMIN000000913.",2020,"No significant difference in DFS was noted between arms (P = 0.163), although 3-, 4-, and 5-year DFS rates were higher with GC.","['102 patients', 'patients with completely resected non-small cell lung cancer', 'Patients with postoperative stage IB-IIIA non-small cell lung cancer']","['cisplatin plus gemcitabine', 'platinum plus gemcitabine (P/G) combinations', 'cisplatin plus gemcitabine (GP arm) or carboplatin plus gemcitabine (GC arm', 'carboplatin plus gemcitabine']","['safety, feasibility, overall survival (OS), and biomarker analyses', '5-year DFS rates', 'feasible and well-tolerated', 'DFS', 'estimated DFS and OS rates', 'efficacy and safety', 'hematological toxic effects', '2-year disease-free survival (DFS', 'Hematological toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",102.0,0.116844,"No significant difference in DFS was noted between arms (P = 0.163), although 3-, 4-, and 5-year DFS rates were higher with GC.","[{'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Fukumoto', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan. s1004fuku@gmail.com.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Oizumi', 'Affiliation': 'First Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Sukoh', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Nakano', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fuke', 'Affiliation': 'Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sakakibara-Konishi', 'Affiliation': 'First Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Takamura', 'Affiliation': 'Department of Respiratory Medicine, Obihiro-Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Respiratory Medicine, Obihiro-Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Nishigaki', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Center for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Akie', 'Affiliation': 'Department of Respiratory Medicine, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Toraji', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Isobe', 'Affiliation': 'Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Dosaka-Akita', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'First Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04104-1'] 2215,32564141,Ultrastructural changes of smooth and rough titanium implant surfaces induced by metal and plastic periodontal probes.,"OBJECTIVES To determine the ultrastructural changes of titanium surfaces of dental implants induced by the tip of periodontal probes. MATERIALS AND METHODS A total of 40 samples of smooth and rough surfaces of titanium implants were randomly assigned for the treatment with metal or plastic periodontal probes under application angles of 20° and 60°. Titanium surfaces have been evaluated with CLSM prior and following to experimental probing determining various standardized 2D and 3D roughness parameters. RESULTS The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material. On smooth surfaces several amplitude roughness parameters were increased with metal probes but reached significance only for Rp (p = 0.007). Rough surface parts showed a slight but not significant reduction of roughness following to the contact with metal probes. The surface roughness remained almost unchanged on smooth and rough implant surfaces using plastic probes. The surface roughness on implant surfaces was not dependent on the application angle irrespective of the probe material. CONCLUSION Probing of titanium implants with metal probes and even less with plastic probes causes only minor changes of the surface roughness. The clinical significance of these changes remains to be elucidated. CLINICAL RELEVANCE Using plastic probes for the clinical evaluation of the peri-implant sulcus might avoid ultrastructural changes to titanium implant surfaces.",2020,The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material.,['A total of 40 samples of smooth and rough surfaces of titanium implants'],[],"['ultrastructural changes of titanium surfaces', 'average profile and surface roughness (Ra and Sa', 'surface roughness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0235481,The average profile and surface roughness (Ra and Sa) showed no significant difference between treated and untreated samples on smooth and rough surface areas irrespective of the probe material.,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Folwaczny', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany. mfolwa@dent.med.uni-muenchen.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Rudolf', 'Affiliation': 'ZEISS Microscopy Customer Center Europe, Carl Zeiss Microscopy GmbH, Oberkochen, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Frasheri', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany.'}, {'ForeName': 'Madlena', 'Initials': 'M', 'LastName': 'Betthäuser', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University, Goethestr. 70, D-80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03341-1'] 2216,32564236,Does prehabilitation modify muscle mass in patients with rectal cancer undergoing neoadjuvant therapy? A subanalysis from the REx randomised controlled trial.,"BACKGROUND Patients with rectal cancer who present with sarcopenia (low muscle mass) are at significantly greater risk of postoperative complications and reduction in disease-free survival. We performed a subanalysis of a randomised controlled study [the REx trial; www.isrctn.com; 62859294] to assess the potential of prehabilitation to modify muscle mass in patients having neoadjuvant chemoradiotherapy (NACRT). METHODS Patients scheduled for NACRT, then potentially curative surgery (August 2014-March 2016) had baseline physical assessment and psoas muscle mass measurement (total psoas index using computed tomography-based measurements). Participants were randomised to either the intervention (13-17-week telephone-guided graduated walking programme) or control group (standard care). Follow-up testing was performed 1-2 weeks before surgery. RESULTS The 44 patients had a mean age of 66.8 years (SD 9.6) and were male (64%); white (98%); American Society of Anesthesiologists class 2 (66%); co-morbid (58%); overweight (72%) (body mass index ≥ 25 kg/m 2 ). At baseline, 14% were sarcopenic. At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease. Conversely, 16 (67%) controls experienced a decrease in muscle mass and 8 (33%) showed an increase. An adjusted linear regression model estimated a mean treatment difference in Total Psoas Index of 40.2mm 2 /m 2 (95% CI - 3.4 to 83.7) between groups in change from baseline (p = 0.07). CONCLUSIONS Prehabilitation improved muscle mass in patients with rectal cancer who had NACRT. These results need to be explored in a larger trial to determine if the poorer short- and long-term patient outcomes associated with low muscle mass can be minimised by prehabilitation.",2020,"At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease.","['Patients with rectal cancer who present with sarcopenia (low muscle mass', 'patients having neoadjuvant chemoradiotherapy (NACRT', 'patients with rectal cancer who had NACRT', '44 patients had a mean age of 66.8\xa0years (SD 9.6) and were male (64%); white (98%); American Society of Anesthesiologists class 2 (66%); co-morbid (58%); overweight (72', 'patients with rectal cancer undergoing neoadjuvant therapy', 'Patients scheduled for NACRT, then potentially curative surgery (August 2014-March 2016) had']","['telephone-guided graduated walking programme) or control group (standard care', 'baseline physical assessment and psoas muscle mass measurement (total psoas index using computed tomography-based measurements']","['muscle mass', 'Total Psoas Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085221', 'cui_str': 'Structure of psoas muscle'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.16134,"At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease.","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Moug', 'Affiliation': 'Department of Surgery, Royal Alexandra Hospital, Corsebar Road, Paisley, PA2 9PN, UK. susanmoug@nhs.net.'}, {'ForeName': 'S J E', 'Initials': 'SJE', 'LastName': 'Barry', 'Affiliation': 'Department of Mathematics and Statistics, Strathclyde University, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Maguire', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Johns', 'Affiliation': 'Western General Hospital, Crewe Road South, Edinburgh, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dolan', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R J C', 'Initials': 'RJC', 'LastName': 'Steele', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buchan', 'Affiliation': 'Department of Surgery, Royal Alexandra Hospital, Paisley, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mackay', 'Affiliation': 'Department of Surgery, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Division of Cancer Research, Ninewells Medical School, Dundee, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Institute of Sport, Physical Education and Health Sciences, Moray House School of Education, Edinburgh, UK.'}]",Techniques in coloproctology,['10.1007/s10151-020-02262-1'] 2217,32564251,Effectiveness of Decision Aid in Men with Localized Prostate Cancer: a Multicenter Randomized Controlled Trial at Tertiary Referral Hospitals in an Asia Pacific Country.,"There are several treatment options for localized prostate cancer with very similar outcome but vary in terms of technique and side effect profiles and risks. Considering the potential difficulty in choosing the best treatment, a patient decision aid (PDA) is used to help patients in their decision-making process. However, the use and applicability of PDA in a country in Asia Pacific region like Malaysia is still unknown. This study aims to evaluate the effectiveness of a PDA modified to the local context in improving patients' knowledge, decisional conflict, and preparation for decision making among men with localized prostate cancer. Sixty patients with localized prostate cancer were randomly assigned to control and intervention groups. A self-administered questionnaire, which evaluate the knowledge on prostate cancer (23 items), decisional conflict (10 items) and preparation for decision-making (10 items), was given to all participants at pre- and post-intervention. Data were analyzed using independent T test and paired T test. The intervention group showed significant improvement in knowledge (p = 0.02) and decisional conflict (p = 0.01) from baseline. However, when compared between the control and intervention groups, there were no significant differences at baseline and post-intervention on knowledge, decisional conflict and preparation for decision-making. A PDA on treatment options of localized prostate cancer modified to the local context in an Asia Pacific country improved patients' knowledge and decisional conflict but did not have significant impact on the preparation for decision-making. The study was also registered under the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12614000668606 registered on 25/06/2014.",2020,The intervention group showed significant improvement in knowledge (p = 0.02) and decisional conflict (p = 0.01) from baseline.,"['men with localized prostate cancer', 'Men with Localized Prostate Cancer', 'Sixty patients with localized prostate cancer']","['Decision Aid', 'PDA']","['knowledge, decisional conflict and preparation for decision-making', 'knowledge', 'decisional conflict']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",60.0,0.0384246,The intervention group showed significant improvement in knowledge (p = 0.02) and decisional conflict (p = 0.01) from baseline.,"[{'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Jalil', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia. yein@upm.edu.my.'}, {'ForeName': 'M Z', 'Initials': 'MZ', 'LastName': 'Nor Afiah', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'F N S Mohd', 'Initials': 'FNSM', 'LastName': 'Azizi', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'N N S Abdul', 'Initials': 'NNSA', 'LastName': 'Rassip', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Ong', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Ng', 'Affiliation': 'Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Cheong', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Razack', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Saad', 'Affiliation': 'Department of Clinical Oncology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alip', 'Affiliation': 'Department of Clinical Oncology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Malek', 'Affiliation': 'Unit of Urology, Selayang Hospital, Selangor, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sundram', 'Affiliation': 'Unit of Urology, General Hospital of Kuala Lumpur, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Omar', 'Affiliation': 'Unit of Urology, Johor Bahru Hospital, Johor Bahru, Johor, Malaysia.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Sathiyananthan', 'Affiliation': 'Unit of Urology, Penang Hospital, Penang, Malaysia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgery, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01801-6'] 2218,32569395,Fast effectiveness of a solubilized low-dose budesonide nasal spray in allergic rhinitis.,"BACKGROUND Budesonide, a poorly water-soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved Budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator. OBJECTIVE The study (EudraCT:2018-001324-19) was designed to assess non-inferiority of Budesolv compared to to Rhinocort® aqua 64 (RA) and early onset of action. METHODS In a three-way cross-over double-blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n=83 (ITT); n=75 (PP)). On day 1, participants entered the Vienna challenge chamber (VCC) for 6 h; first treatment took place at 1:45 h after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge. RESULTS Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (p<0.05) and 15 minutes (p<0.05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application. CONCLUSIONS AND CLINICAL RELEVANCE The novel preservative free, aqueous low-dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.",2020,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application. ","['allergic rhinitis', 'grass pollen allergic rhinoconjunctivitis volunteers (n=83 (ITT); n=75 (PP']","['Budesonide', 'RA and placebo', 'solubilized low-dose budesonide nasal spray']","['TNSS and nasal airflow', 'Subjective symptom scores, nasal airflow and nasal secretion', 'nasal symptom score', 'nasal and respiratory symptoms']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0678163', 'cui_str': 'Rhinocort'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",,0.0434773,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application. ","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmutz', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Unger-Manhart', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Nakowitsch', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goessl', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Savli', 'Affiliation': 'Biostatistik & Consulting, Oberwart, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prieschl-Grassauer', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13691'] 2219,32569414,Randomized pragmatic pilot trial comparing perpendicular thin electrodes versus parallel thick electrodes approaches for lumbar medial branch neurotomy in facetogenic low back pain.,"OBJECTIVES Although there are different ways of performing medial branch neurotomy on facetogenic low back pain, few studies have compared clinical outcomes of a parallel technique over the medial branch versus a perpendicular technique. We investigated differences in pain outcome with both techniques. DESIGN This was a prospective, pilot, randomized, pragmatic trial (double-blinded in diagnostic phase). SETTING A comparative pilot trial was conducted at an academic pain centre. METHODS Patients who did not respond to conservative medications and had severe lumbar pain for more than 3 months (VAS≥65) were included. A double diagnostic block with local anaesthetic and placebo was performed, double blinded. Patients who had an 80% relief from the local anaesthetic and no substantial relief from placebo were randomized to receive a medial branch neurotomy placing an electrode parallel or perpendicular to the medial branch, under fluoroscopy. PRIMARY OUTCOME differences in Visual Analogue Scale at 1, 3 and 6 months. SECONDARY OUTCOMES Oswestry Disability Index, Roland Morris Questionnaire and other functional Likert scales. RESULTS Forty-three consecutive patients were randomized to parallel (n=20) or perpendicular (n=23) neurotomy. There were no significant differences in Visual Analogue Scale, Oswestry or Roland Morris at 1, 3 or 6 months between groups. Statistically significant differences were found in the categorical analysis at six months, in the evolution of pain, Oswestry, Roland Morris and some Likert scales in favour of the parallel group. CONCLUSIONS There are differences at 6 months in the categorical analysis of the evolution of pain, Oswestry, Roland Morris and in some functional Likert scales, all in favour of the parallel group.",2020,"There were no significant differences in Visual Analogue Scale, Oswestry or Roland Morris at 1, 3 or 6 months between groups.","['academic pain centre', 'Patients who had an 80% relief from the local anaesthetic and no substantial relief from', 'Forty-three consecutive patients were randomized to parallel (n=20) or perpendicular (n=23) neurotomy', 'facetogenic low back pain', 'Patients who did not respond to conservative medications and had severe lumbar pain for more than 3 months (VAS≥65) were included']","['local anaesthetic and placebo', 'medial branch neurotomy placing an electrode parallel or perpendicular to the medial branch, under fluoroscopy', 'perpendicular thin electrodes versus parallel thick electrodes approaches', 'placebo']","['Oswestry Disability Index, Roland Morris Questionnaire and other functional Likert scales', 'Visual Analogue Scale', 'evolution of pain, Oswestry, Roland Morris and some Likert scales', 'pain outcome', 'evolution of pain, Oswestry, Roland Morris and in some functional Likert scales', 'Visual Analogue Scale, Oswestry or Roland Morris']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0196558', 'cui_str': 'Incision of nerve'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0196558', 'cui_str': 'Incision of nerve'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",43.0,0.572113,"There were no significant differences in Visual Analogue Scale, Oswestry or Roland Morris at 1, 3 or 6 months between groups.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Andrés Ares', 'Affiliation': 'Unidad del Dolor Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gilsanz', 'Affiliation': 'Unidad del Dolor Hospital Universitario La Paz, Madrid, Spain.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12928'] 2220,32569429,A Pilot Trial of Topical Capsaicin Cream for Treatment of Cannabinoid Hyperemesis Syndrome.,"BACKGROUND Patients with cannabinoid hyperemesis syndrome (CHS) present frequently to the emergency department. Previous case studies suggest dramatic symptomatic improvement with topical capsaicin treatment. This exploratory study examined the potential effectiveness of topical capsaicin in patients with nausea and vomiting due to a suspected CHS exacerbation. METHODS This was a double-blind, randomized placebo-controlled pilot trial. Adults who presented with vomiting suspected to be from CHS were eligible for enrollment. We excluded pregnant women and those with resolution of symptoms. Following randomization, topical 0.1% capsaicin or placebo cream was applied to the anterior abdomen in a uniform manner. The primary outcome was the severity of nausea on a visual analog scale (VAS) of 0-10 cm assessed at 30 minutes. Secondary outcomes were adverse events, occurrence of post-treatment vomiting, nausea by VAS at 60 minutes, and hospital admission. RESULTS This pilot trial enrolled 30 patients; 17 in the capsaicin arm and 13 in the placebo arm. One patient in the capsaicin arm did not tolerate treatment due to skin irritation. Mean nausea severity at 30 minutes was 4.1 ±2.3 cm in the capsaicin arm and 6.1 ±3.3 cm in the placebo arm (difference -2.0 cm, 95% CI, 0.2 to -4.2 cm). At 60 minutes, mean nausea severity was 3.2 ±3.2 cm versus 6.4 ±2.8 cm (difference -3.2 cm, 95% CI, -0.9 to -5.4 cm). The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference 21.1%, 95% CI, -5.6% to 47.9%). A higher proportion of capsaicin group patients (29.4% vs. 0%) had complete resolution of nausea (RR 3.4, 95% CI, 1.6 to 7.1). CONCLUSION In this pilot trial, the application of topical capsaicin cream was associated with a significant reduction in nausea at 60 minutes but not at 30 minutes and provided more complete relief of nausea.",2020,"The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference 21.1%, 95% CI, -5.6% to 47.9%).","['Adults who presented with vomiting suspected to be from CHS were eligible for enrollment', 'patients with nausea and vomiting due to a suspected CHS exacerbation', 'pregnant women and those with resolution of symptoms', '30 patients; 17 in the capsaicin arm and 13 in the placebo arm', 'Patients with cannabinoid hyperemesis syndrome (CHS', 'Cannabinoid Hyperemesis Syndrome']","['Topical Capsaicin Cream', 'topical capsaicin', 'topical 0.1% capsaicin or placebo cream', 'topical capsaicin cream', 'capsaicin', 'placebo']","['skin irritation', 'severity of nausea on a visual analog scale (VAS) of 0-10 cm assessed at 30 minutes', 'Mean nausea severity', 'complete resolution of nausea', 'complete relief of nausea', 'nausea', 'adverse events, occurrence of post-treatment vomiting, nausea by VAS at 60 minutes, and hospital admission', 'mean nausea severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",30.0,0.533538,"The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference 21.1%, 95% CI, -5.6% to 47.9%).","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Dean', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Sabagha', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'France', 'Affiliation': 'Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Asmar', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Rammal', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Beyer', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bussa', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Kaleem', 'Initials': 'K', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smoot', 'Affiliation': 'Frederick Memorial Hospital, Frederick, MD, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14062'] 2221,32569507,"Brief, peer-delivered motivational interview promotes help seeking behavior among college students with needle anxiety: A randomized controlled trial.","Needle anxiety symptoms are prevalent among college students and predict lack of engagement in student health initiatives including influenza immunization programs. Most do not seek treatment for their anxiety. Objective: To develop and test a peer-delivered, brief motivational interview to promote help-seeking behaviors among college students with needle anxiety symptoms. Participants/Methods: 61 university students who reported needle anxiety symptoms and having avoided medical situations involving needles in the last year were randomized to intervention or control conditions. Analyses compared self-reported help seeking behaviors at three months post-intervention. Results: Intervention group participants were more than twice as likely to report help-seeking behavior at follow up ( IR  = 2.41; 95%CI  = 1.29, 4.50; p =.006) than the control group. Participants also endorsed high levels of satisfaction with the intervention. Conclusions: This pilot intervention appears acceptable and feasible to implement using peers in the college setting. There is preliminary evidence for efficacy, with larger-scale replication needed.",2020,"Intervention group participants were more than twice as likely to report help-seeking behavior at follow up ( IR  = 2.41; 95%CI  = 1.29, 4.50; p =.006) than the control group.","['college students with needle anxiety', '61 university students who reported needle anxiety symptoms and having avoided medical situations involving needles in the last year', 'college students', 'college students with needle anxiety symptoms']",['peer-delivered motivational interview'],"['seeking behaviors', 'Needle anxiety symptoms', 'seeking behavior']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0236198,"Intervention group participants were more than twice as likely to report help-seeking behavior at follow up ( IR  = 2.41; 95%CI  = 1.29, 4.50; p =.006) than the control group.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Finitsis', 'Affiliation': 'Health Services Delivery Research, Hartford Hospital, Hartford, Connecticut, USA.'}, {'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Cruess', 'Affiliation': 'Department of Psychology, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Sharishma', 'Initials': 'S', 'LastName': 'Pinnamaraju', 'Affiliation': 'Health Services Delivery Research, Hartford Hospital, Hartford, Connecticut, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychology, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Torri A', 'Initials': 'TA', 'LastName': 'Woodruff', 'Affiliation': 'Department of Psychology, University of Connecticut, Storrs, Connecticut, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1763365'] 2222,32569678,Ovulation inhibition with a new vaginal ring containing trimegestone.,"OBJECTIVES The primary objective was to determine the lowest trimegestone (TMG) dose, administered via a vaginal ring, that effectively inhibited ovulation. STUDY DESIGN Single-centre, open-label, single-dose, parallel-group clinical trial with adaptive design. Eighty healthy female volunteers with proven ovulatory cycles were allocated to treatment with a vaginal ring during 28 days, with an average daily release rate of either 46µg, 94µg, 147µg, or 184µg TMG (20 women/group). Ultrasound measurements of follicular growth and endometrial thickness, and blood sampling for follicle-stimulating hormone, luteinizing hormone, estradiol and progesterone determinations were performed every 3 rd (±1) day from treatment day 4 (±1) until day 28 (±1), and in a follow-up phase after ring removal, until study day 39 (±1). Trimegestone concentrations were measured at each visit in the treatment phase. RESULTS Mean age and body mass index were 28.8 years and 23.15 kg/m 2 . One subject in the lowest dose group (46 µg/day) ovulated, no ovulations were seen in the higher dose groups. The degree of ovarian suppression increased with the dose. Median estradiol levels were 119, 36.5, 33.2 and 27.2 pg/mL in the 46, 94, 147and 184 µg/day groups, respectively. Ovarian activity was resumed in the follow-up phase. Plasma TMG levels gradually declined over the treatment period and showed dose proportionality. The study treatment was safe and well tolerated. CONCLUSION The release rate of 94 µg TMG per day was the lowest effective dose for ovulation inhibition. The study results justify further development of the TMG-ring as progestogen-only contraceptive. IMPLICATIONS The vaginal ring releasing TMG seems to be an effective new progestogen-only contraceptive preparation, having the advantage of once-a-month vaginal insertion.",2020,"One subject in the lowest dose group (46 µg/day) ovulated, no ovulations were seen in the higher dose groups.","['Mean age and body mass index were 28.8 years and 23.15 kg/m 2 ', 'Eighty healthy female volunteers with proven ovulatory cycles']","['TMG-ring as progestogen-only contraceptive', 'lowest trimegestone (TMG', 'trimegestone']","['Plasma TMG levels', 'Ovulation inhibition', 'degree of ovarian suppression', 'Median estradiol levels', 'Trimegestone concentrations', 'release rate', 'safe and well tolerated', 'Ovarian activity', 'Ultrasound measurements of follicular growth and endometrial thickness, and blood sampling for follicle-stimulating hormone, luteinizing hormone, estradiol and progesterone determinations']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}]","[{'cui': 'C0628822', 'cui_str': 'trimegestone'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0628822', 'cui_str': 'trimegestone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029968', 'cui_str': 'Ovulation Suppression'}, {'cui': 'C0677922', 'cui_str': 'Ovarian ablation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]",80.0,0.0599633,"One subject in the lowest dose group (46 µg/day) ovulated, no ovulations were seen in the higher dose groups.","[{'ForeName': 'Ingrid J M', 'Initials': 'IJM', 'LastName': 'Duijkers', 'Affiliation': 'dinox consultancy bv, Marktstraat 19, 9712 PB Groningen, the Netherlands. Electronic address: id@dinoxconsultancy.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klipping', 'Affiliation': 'dinox consultancy bv, Marktstraat 19, 9712 PB Groningen, the Netherlands; dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany. Electronic address: ck@dinoxconsultancy.com.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Draeger', 'Affiliation': 'dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany. Electronic address: corinna.draeger@dinox.de.'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'Schug', 'Affiliation': 'SocraTec R&D GmbH, Im Setzling 35, 61440 Oberursel, Germany. Electronic address: Barbara.Schug@socratec-pharma.de.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Dax', 'Affiliation': 'SocraTec R&D GmbH, Im Setzling 35, 61440 Oberursel, Germany. Electronic address: Annika.Dax@socratec-pharma.de.'}, {'ForeName': 'Maika', 'Initials': 'M', 'LastName': 'Friedrich', 'Affiliation': 'Evestra GmbH, Britzer Straße 26, 12439 Berlin, Germany. Electronic address: mfriedrich@evestra.com.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Nickisch', 'Affiliation': 'Evestra GmbH, Britzer Straße 26, 12439 Berlin, Germany. Electronic address: knickisch@evestra.com.'}]",Contraception,['10.1016/j.contraception.2020.06.006'] 2223,32569700,The effects of combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy on intermediate markers of cardiovascular risk in the CANVAS program.,"BACKGROUND Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA) reduce cardiovascular events, and improve intermediate markers of cardiometabolic health, in those with type 2 diabetes. We investigated these effects in the CANVAS Program. METHODS AND RESULTS The CANVAS Program comprised 2 double-blind, randomized, placebo-controlled trials (CANVAS and CANVAS-R) done in patients with type 2 diabetes and elevated cardiovascular risk. Effects were estimated using mixed-effects models for continuous measures and Cox regression models for other outcomes. Randomized treatment by subgroup interaction terms were used to compare effects of canagliflozin versus placebo across subgroups defined by baseline use of GLP1-RA. There were 10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline. Those using GLP1-RA at baseline were less likely to have a history of cardiovascular disease (60.4% vs 65.8%), had a longer duration of diabetes (15.2 vs 13.5 years) and a higher body mass index (BMI; 35.6 vs 31.8 kg/m 2 ) but were otherwise similar. There were greater reductions with canagliflozin versus placebo for HbA1c (-0.75% versus -0.58%; P = .0091), SBP (-6.26 versus -3.83 mmHg; P = .0018), and body weight (-3.79 versus -2.18 kg; P < .0001) in those on baseline GLP1-RA therapy. Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74). CONCLUSIONS There may be a synergistic effect of SGLT2 inhibition when used on a background of GLP1-RA for intermediate cardiometabolic markers.",2020,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74). ","['10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline', 'patients with type 2 diabetes and elevated cardiovascular risk']","['canagliflozin versus placebo', 'placebo-controlled trials (CANVAS and CANVAS-R', 'combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy', 'Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA']","['body weight', 'history of cardiovascular disease', 'total serious adverse events', 'major adverse cardiac events', 'longer duration of diabetes', 'SBP', 'eGFR slope']","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",10142.0,0.359796,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74). ","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia. Electronic address: bneal@georgeinstitute.org.au.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of New South Wales, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia; Kolling Institute, Royal North Shore Hospital and University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.""}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Lam', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; National Heart Centre Singapore and Duke-National University, Singapore.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Baim Institute for Clinical Research, Boston, MA, USA.""}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.011'] 2224,32569757,"A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment.","Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a ""coverage with evidence"" trial. This study, entitled, A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees. Predetermined interim analyses will define the necessary sample size. All participants will be implanted with VNS devices: half receive active stimulation during year one, and half receive delayed stimulation after year one. Participants will be followed for 5 years. This RCT is unique for DTD studies: 1) large sample size and long study duration (one year of controlled comparison); 2) use of a percent time in response as the primary outcome measure, given the chronic illness and its fluctuating course (vis-à-vis meeting a response criteria at a single time point); 3) inclusion of diverse measures of VNS impact on function, including quality of life, degree of disability, health status, and suicidality.",2020,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"['depression', 'patients with difficult-to-treat depression (DTD', 'Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees']","['vagus nerve stimulation', 'VNS Therapy® System as AdjunctivE Therapy']","['quality of life, degree of disability, health status, and suicidality']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220726', 'cui_str': 'Diastrophic dysplasia'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.0937023,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: conwaycr@wustl.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Olin', 'Affiliation': 'LivaNova PLC, London, United Kingdom. Electronic address: bryan.olin@livanova.com.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Aaronson', 'Affiliation': 'Sheppard Pratt Health System, Department of Psychiatry, University of Maryland, Baltimore, MD, USA. Electronic address: SAaronson@sheppardpratt.org.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, New York, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bunker', 'Affiliation': 'LivaNova PLC, Houston, TX, USA. Electronic address: Mark.Bunker@livanova.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kriedt', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: ckriedt@wustl.edu.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Greco', 'Affiliation': 'LivaNova PLC, SORIN Group Italia S.r.l., Milano, Italy. Electronic address: teresa.greco@livanova.com.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Berry Consultants, Austin, TX, USA; Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vestrucci', 'Affiliation': 'Berry Consultants, Austin, TX, USA; Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA. Electronic address: matteo@berryconsultants.net.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': 'Duke-NUS Medical School, Singapore; Duke University, Durham, NC, USA; Texas Tech University, Permian Basin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106066'] 2225,32569854,Improving imagery rescripting treatments: Comparing an active versus passive approach.,"BACKGROUND AND OBJECTIVES In imagery rescripting (ImRs), aversive mental images are modified to reduce symptoms in a variety of psychological disorders. However, uniform guidelines on how to optimally implement ImRs do currently not exist. It remains unclear whether therapists should stimulate patients to imagine themselves to actively intervene within the new image, or whether they may imagine helpers to change the situation. We aimed to compare these two variants of ImRs within an analogue experimental setting. METHODS After having watched an aversive film, one-hundred participants were randomly assigned to active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC). Participants were either instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P). RESULTS Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy. Conditions did not differ regarding the number of film-related intrusive memories. LIMITATIONS As a convenience sample was investigated, results cannot be generalized to clinical samples. CONCLUSION Even though differences regarding symptomatic outcome could not be detected, ImRs-P was experienced as less distressing than ImRs-A. Results suggest that both ImRs lead to different processes during the intervention than mere exposure. Compared to IRE, ImRs increases mastery with ImRs-A and ImRs-P being equally effective.",2020,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","['After having watched an aversive film, one-hundred participants']","['active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC', 'instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P']",['number of film-related intrusive memories'],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}]",100.0,0.0317839,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","[{'ForeName': 'Marena', 'Initials': 'M', 'LastName': 'Siegesleitner', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Strohm', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Wittekind', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kunze', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany. Electronic address: anna.kunze@psy.lmu.de.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101578'] 2226,32570152,To study the changes in maternal hemodynamics with intravenous labetalol or nifedipine in acute severe hypertension.,"OBJECTIVE To study the maternal hemodynamic changes in acute severe hypertension after treatment with intravenous labetalol or oral nifedipine using color doppler ultrasound. STUDY DESIGN We evaluated thirty pregnant women with gestational age between 28 and 40 weeks in acute severe hypertension (more than or equal to 160/105 mmHg) which were randomly allocated to receive either intravenous labetalol or oral nifedipine until blood pressure was lowered to less than or equal to 140/90 mmHg. Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery were measured baseline at the time of acute severe hypertension and repeated after control of blood pressure, to assess the changes in maternal hemodynamics if any with labetalol or nifedipine. RESULTS When evaluating right uterine artery Doppler parameters, a trend to increase in PI and RI was observed in those who received labetalol and nifedipine however the difference was not statistically significant. Whereas, while evaluating left uterine artery indices a trend to decrease PI was seen in nifedipine group but the difference was not statistically significant. On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group. CONCLUSION The use of labetalol and nifedipine were not related to any significant changes in maternal Doppler, which is reassuring about the safety of these drugs when treating acute severe hypertension in pregnancy.",2020,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group. ","['thirty pregnant women with gestational age between 28 and 40\xa0weeks in acute severe hypertension (more than or equal to 160/105\xa0mmHg', 'acute severe hypertension', 'acute severe hypertension after treatment with intravenous']","['labetalol or nifedipine', 'nifedipine', 'labetalol or oral nifedipine', 'intravenous labetalol or oral nifedipine', 'labetalol and nifedipine', 'labetalol']","['renal artery indices', 'Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery', 'PI and RI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",30.0,0.0341283,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group. ","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Department of Obstetrics & Gynaecology, YSPGMC, Nahan, India. Electronic address: thakurmonika126@gmail.com.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gainder', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Saha', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, PGIMER, Chandigarh, India.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.014'] 2227,32570178,Effects of a 10-week multimodal dance and art intervention program leading to a public performance in persons with multiple sclerosis - A controlled pilot-trial.,"BACKGROUND Dance therapy is increasingly reported in neurological diseases for improving several motor and cognitive functions, but was mostly studied in partner dance. No individual choreo-based dance program has ever been reported in MS. OBJECTIVES The aim of this pilot study is to investigate effects of a ten-week choreo-based dance intervention on different impairments in MS. PARTICIPANTS Seventeen participants with MS were allocated to a dance group (DG) or an art group (AG) for a ten-week intervention program, with a public live performance at the end of the intervention. METHODS The DG received choreo-based dance courses twice a week for 90 min, while the active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography. Measurements for fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place before and after the intervention. Differences were analysed with Wilcoxon Signed Rank test. RESULTS Both groups improved significantly on executive cognitive performance during dual task and fatigue. Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT). The AG showed significant improvements in on cognitive function (SDMT). CONCLUSION A ten-week multimodal dance intervention has positive effects on impact of fatigue, physical capacity and coordination, and cognitive performance during a dual task. Larger samples, follow-up measurements and research in different disability groups is recommended.",2020,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","['persons with multiple sclerosis', 'Seventeen participants with MS']","['active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography', 'ten-week choreo-based dance intervention', 'multimodal dance and art intervention program', 'dance group (DG) or an art group (AG']","['functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT', 'impact of fatigue, physical capacity and coordination, and cognitive performance', 'executive cognitive performance', 'fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place', 'cognitive function (SDMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",17.0,0.0172608,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Van Geel', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: fanny.vangeel@uhasselt.be.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Fit Up Neurological and Sport Physiotherapy, Antwerp, Belgium; Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Veldkamp', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: renee.veldkamp@uhasselt.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: peter.feys@uhasselt.be.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102256'] 2228,32570237,Single-Center Noninferiority Randomized Trial on the Efficacy and Safety of Low- and High-Dose Rush Oral Milk Immunotherapy for Severe Milk Allergy.,"INTRODUCTION Oral immunotherapy (OIT) has been reported to be effective but associated with a risk of severe symptoms. Thus, an OIT method with decreased risk is required. OBJECTIVES We aimed to evaluate the efficacy and safety of low- and high-dose OIT regimens in children with severe milk allergy. METHODS Overall, 33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included. The participants were randomly assigned to groups that received either a low (20 mL; n = 19) or high (100 mL; n = 14) maintenance target dose of OIT. The dose was gradually increased to the target dose in the rush escalation phase and was then maintained daily at home. The primary endpoint was the final OFC dose at 6 months of OIT. Adverse events during OIT were evaluated. RESULTS The final OFC dose after OIT was significantly higher than that before OIT in both groups (low-dose, p = 0.000; high-dose, p = 0.006), but there was no significant difference in the final OFC dose between the 2 groups (p = 0.767). In the maintenance phase, the high-dose group had significantly more severe symptoms than did the low-dose group (0.5%, 11/2,355 total intake events vs. 0.1%, 4/3,230 total intake events; p = 0.018). CONCLUSIONS An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy. The risk of severe symptoms in the maintenance phase was lower in the low-dose group. A low-dose OIT regimen is recommended for severe milk allergy.",2020,An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy.,"['Severe Milk Allergy', '33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included', 'children with severe milk allergy']","['Low- and High-Dose Rush Oral Milk Immunotherapy', 'low- and high-dose OIT regimens']","['final OFC dose after OIT', 'Adverse events', 'severe symptoms', 'efficacy and safety', 'final OFC dose at 6 months of OIT', 'risk of severe symptoms', 'final OFC dose']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0079840', 'cui_str': 'Milk allergy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0443052', 'cui_str': 'Rush'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0474029,An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy.,"[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Takaoka', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan, zvb11075@nifty.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yajima', 'Affiliation': 'Department of Pediatrics, Tannan Regional Medical Center, Sabae, Japan.'}, {'ForeName': 'Yoichi M', 'Initials': 'YM', 'LastName': 'Ito', 'Affiliation': 'Department of Biostatics, Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Kumon', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Muroya', 'Affiliation': 'Department of Pediatrics, Suita Municipal Hospital, Suita, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Tsurinaga', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Shigekawa', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pediatrics, Sumitomo Hospital, Osaka, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Iba', 'Affiliation': 'Department of Pediatrics, Arida Municipal Hospital, Arida, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Department of Pediatrics, Okinawa Chubu Hospital, Uruma, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Nishikido', 'Affiliation': ""Department of Respiratory and Allergy, Osaka Women's and Children's Hospital, Izumi, Japan.""}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Faculty of Education, Shitennoji University, Habikino, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kameda', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}]",International archives of allergy and immunology,['10.1159/000508627'] 2229,32570250,Negative-Pressure Ureteroscopic Holmium-YAG Laser Lithotripsy for Ureteral Stones.,"OBJECTIVES The aim of this study was to describe a novel negative-pressure laser lithotripsy device to overcome the deficiencies of the conventional procedure. PATIENTS AND METHODS Between August 2018 and March 2019, 78 patients with a single ureteral stone underwent retrograde ureteroscopy with a Wolf 8F/9.8F rigid ureteroscope and a 200-μm holmium-YAG laser. The mean stone size was 11.8 mm, measured for the maximum length. The negative-pressure laser lithotripsy device consists of an F5 ureter catheter and a T joint. The closed tip of an F5 ureter catheter is cut off, and it is then inserted within one opening of the T joint. The 200-μm laser fiber is introduced into the ureteral catheter through the other opening of the T joint. The third opening of the T joint is connected to the negative-pressure pipe. The valve end of the Foley catheter is used for sealing the cap. Continuous suction and active irrigation throughout the lithotripsy could maintain adequate visibility. RESULTS All ureteroscopic procedures were successful. The negative-pressure device showed good stone retention capabilities, with no observed stone migration. We did not observe any major complications. The stone-free rate was 97.44% (76/78), demonstrated on plain radiography of the kidney-ureter-bladder on the first postoperative day. The stone-free rate after 1 month was 100%. CONCLUSIONS The negative-pressure ureteroscopic lithotripsy is easy and safe management for the ureteral stones. It might reduce the risk of stone fragment retropulsion, improve surgical vision, shorten the operative time, and decrease the renal pelvic pressure.",2020,"The stone-free rate was 97.44% (76/78), demonstrated on plain radiography of the kidney-ureter-bladder on the first postoperative day.","['Between August 2018 and March 2019, 78 patients with a single ureteral stone underwent']","['novel negative-pressure laser lithotripsy device', 'Negative-Pressure Ureteroscopic Holmium-YAG Laser Lithotripsy', 'retrograde ureteroscopy with a Wolf 8F/9.8F rigid ureteroscope and a 200-μm holmium-YAG laser']","['renal pelvic pressure', 'stone-free rate', 'mean stone size']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0392307', 'cui_str': 'Rigid ureteroscope'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0227666', 'cui_str': 'Renal pelvis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",78.0,0.027111,"The stone-free rate was 97.44% (76/78), demonstrated on plain radiography of the kidney-ureter-bladder on the first postoperative day.","[{'ForeName': 'Zhong-Hua', 'Initials': 'ZH', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China, daydreamwu@sina.com.'}, {'ForeName': 'Tong-Zu', 'Initials': 'TZ', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xing-Huan', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yong-Zhi', 'Initials': 'YZ', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yin-Gao', 'Initials': 'YG', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xin-Hua', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}]",Urologia internationalis,['10.1159/000507266'] 2230,32564499,Reduced pain and analgesic use after acoustic binaural beats therapy in chronic pain - a double blind randomized control cross-over trial.,"BACKGROUND Binaural Beats (BB) consist of two artificial acoustic stimuli with different frequency, presented simultaneously but independently to each ear. The human brain perceives and synchronizes to this frequency difference (entrainment). METHODS In a double blind, randomized, cross-over trial, BB at 5Hz (theta rhythm) were applied for 30 minutes, under simultaneous electroencephalogram recordings, followed by liberal, on demand use by chronic pain patients for a week, compared to sham stimulation (SS). Pain as the main outcome (numeric scale, NRS), stress (STAI) and medication usage (defined daily doses, DDD) were assessed at baseline, 30 minutes and week's end. RESULTS Perceived pain (NRS) was significantly reduced in BB intervention (5.6±2.3 to 3.4±2.6, p<0.001), compared to SS (5.2±2.1 to 4.8±2.3, p=0.78), during the first 30-minute phase, as well as at the week's end (to 3.9±2.5 compared to 5.5±2.6 respectively, p<0.001). The mean EEG theta power at 5Hz was significantly increased only during BB application. Stress was significantly reduced at 30 minutes in both interventions but remained reduced only in the BB group at the week's end. Analgesic medication consumption (DDD, g) during the week was significantly less in the BB intervention (3.9±3.7 vs. 4.6±4.1, p<0.05), while reporting equal to SS mean levels of pain. CONCLUSIONS Acoustic BB reduced pain intensity, stress and analgesic use, compared to SS, in chronic pain patients.",2020,Stress was significantly reduced at 30 minutes in both interventions but remained reduced only in the BB group at the week's end.,['chronic pain patients'],"['acoustic binaural beats therapy', 'Acoustic BB']","['pain intensity, stress and analgesic use', 'Stress', 'pain and analgesic use', 'Perceived pain (NRS', 'Pain as the main outcome (numeric scale, NRS), stress (STAI) and medication usage (defined daily doses, DDD', 'Analgesic medication consumption (DDD, g', 'mean EEG theta power at 5Hz']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011037', 'cui_str': 'DDD'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",,0.0804744,Stress was significantly reduced at 30 minutes in both interventions but remained reduced only in the BB group at the week's end.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gkolias', 'Affiliation': 'Lab. of. Clinical Pharmacology, Dept. of Medicine, A.U.T.H, Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Amaniti', 'Affiliation': 'AHEPA University Hospital, Dept. of Medicine, A.U.T.H, Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Triantafyllou', 'Affiliation': 'Dept. of Internal Medicine, Papageorgiou Hospital, A.U.T.H, Thessaloniki, Greece.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Papakonstantinou', 'Affiliation': 'AHEPA University Hospital, Dept. of Medicine, A.U.T.H, Thessaloniki, Greece.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kartsidis', 'Affiliation': 'Lab. of Medical Physics, Dept. of Medicine, A.U.T.H, Thessaloniki, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paraskevopoulos', 'Affiliation': 'Lab. of Medical Physics, Dept. of Medicine, A.U.T.H, Thessaloniki, Greece.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Bamidis', 'Affiliation': 'Lab. of Medical Physics, Dept. of Medicine, A.U.T.H, Thessaloniki, Greece.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hadjileontiadis', 'Affiliation': 'Dept. of Electrical and Computer Engineering, A.U.T.H, Dept. of Electrical and Computer Engineering, Khalifa University of Science and Technology, Abu Dhabi, UAE.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kouvelas', 'Affiliation': 'Lab. of. Clinical Pharmacology, Dept. of Medicine, A.U.T.H, Thessaloniki, Greece.'}]","European journal of pain (London, England)",['10.1002/ejp.1615'] 2231,32564571,The effect of antiplatelet drug on coronary endothelial and microvascular function: comparison with ticagrelor and clopidogrel.,"Background/Aims Coronary endothelial and microvascular function play important roles in cardiovascular disease. We aimed to evaluate the effect of ticagrelor on coronary artery function and tested the antiplatelet effect of low dose ticagrelor in East-Asian patients. Methods Sixty-one consecutive patients with non-significant coronary disease were included in the study. Initially, patients were randomized in 1:1:1 ratio to receive drugs: ticagrelor 90 mg twice a day (bid; n = 22), ticagrelor 45 mg bid (n = 19) or clopidogrel 75 mg once a day (qd; n = 20) and then divided into two groups (ticagrelor vs clopidogrel) for evaluation of coronary artery function, and three groups for evaluation of antiplatelet function. Endothelial dysfunction was measured by coronary flow reserve (CFR), and changes in the levels of asymmetric dimethylarginine (ADMA), cluster of differentiation (CD) 40 ligand, and P-selectin. Microvascular function was evaluated as index of microvascular resistance (IMR). Platelet reactivity was assessed by VerifyNow P2Y12 assay. Results The levels of CFR, ADMA, and CD 40 ligand were not different between the two groups. However, P-selectin was lower in the ticagrelor group compared with clopidogrel group. IMR was significantly lower in the ticagrelor group compared with clopidogrel group (median, 15.0 [interquartile range, 12.0 to 21.0] vs. 47.5 [23.0 to 67.5], p = 0.014). There was significant difference in platelet inhibition among the three groups (ticagrelor 90 mg bid vs. ticagrelor 45 mg bid vs. clopidogrel 75 mg qd; 85.57 ± 47.63 vs. 120.33 ± 51.09 vs. 256.42 ± 55.10, p < 0.001). Conclusions It is hypothesized that ticagrelor might ameliorate the coronary microvascular function. When compared with clopidogrel, low dose ticagrelor exhibited satisfactory antiplatelet effect in the present study.",2020,"The levels of CFR, ADMA, and CD 40 ligand were not different between the two groups.","['East-Asian patients', 'Methods\n\n\nSixty-one consecutive patients with non-significant coronary disease were included in the study']","['ticagrelor and clopidogrel', 'ticagrelor 45 mg bid (n = 19) or clopidogrel', 'ticagrelor vs clopidogrel', 'clopidogrel', 'drugs: ticagrelor', 'ticagrelor']","['levels of CFR, ADMA, and CD 40 ligand', 'Endothelial dysfunction', 'IMR', 'coronary microvascular function', 'Platelet reactivity', 'platelet inhibition', 'coronary flow reserve (CFR), and changes in the levels of asymmetric dimethylarginine (ADMA), cluster of differentiation (CD) 40 ligand, and P-selectin', 'coronary artery function', 'index of microvascular resistance (IMR', 'Microvascular function', 'P-selectin', 'coronary endothelial and microvascular function']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}]",61.0,0.0371023,"The levels of CFR, ADMA, and CD 40 ligand were not different between the two groups.","[{'ForeName': 'Woong Gil', 'Initials': 'WG', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Gi Chang', 'Initials': 'GC', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Cheol Ho', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Hye Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2019.293'] 2232,32564630,Effectiveness of Self-Compassion Intervention on Criminal Thinking in Male Prisoners.,"This study aimed to investigate the effectiveness of self-compassion intervention on criminal thinking in male prisoners. A quasi-experimental design utilizing pre-test, post-test, and follow-up test and waiting-list control groups was conducted. A total of 24 male prisoners were selected by purposeful sampling and randomized into experimental and waiting list control groups. Participants of experimental group received eight sessions of self-compassion intervention; and all participants answered to psychological inventory of criminal thinking styles (PICTS) as dependent variable at three time points (pre-test, post-test, and 2-month follow-up). A repeated measures analysis of variance was used to analyze the data. Results showed criminal thinking was significantly decreased in experimental group, as compared to control, at post-test phase ( p  < .01); and improvement of criminal thinking in the follow-up phase has also been continued ( p  < .05). Therefore, to reduce criminal behaviors or rehabilitation of prisoners, self-compassion based intervention can be used.",2020,"Results showed criminal thinking was significantly decreased in experimental group, as compared to control, at post-test phase ( p  < .01); and improvement of criminal thinking in the follow-up phase has also been continued ( p  < .05).","['24 male prisoners', 'male prisoners', 'Male Prisoners']","['Self-Compassion Intervention', 'self-compassion intervention', 'eight sessions of self-compassion intervention; and all participants answered to psychological inventory of criminal thinking styles (PICTS']","['Criminal Thinking', 'criminal thinking']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}]","[{'cui': 'C0699726', 'cui_str': 'Offenders'}]",24.0,0.0120026,"Results showed criminal thinking was significantly decreased in experimental group, as compared to control, at post-test phase ( p  < .01); and improvement of criminal thinking in the follow-up phase has also been continued ( p  < .05).","[{'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Rezapour-Mirsaleh', 'Affiliation': 'Ardakan University, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Shafizadeh', 'Affiliation': 'Ardakan University, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Shomali', 'Affiliation': 'Organization of Prisons Affairs, Ardakan, Iran.'}, {'ForeName': 'Raziyeh', 'Initials': 'R', 'LastName': 'Sedaghat', 'Affiliation': 'Ministry of Education, Yazd, Iran.'}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X20936192'] 2233,32564645,COMT by DRD3 Epistatic Interaction in Modulating Behaviors in Children with ADHD: A Pharmaco-Dynamic Behavioral Approach.,"OBJECTIVE Examining the joint effect of two functional variants in two dopamine-related genes ( DRD3 and COMT ) on ADHD-relevant behaviors under three experimental conditions (EC). METHOD 362 children with ADHD were assessed by parents and teachers during a week of baseline evaluation, followed by 1 week of MPH and placebo, administered in a double-blind crossover design. RESULTS Statistically significant 3-way ( DRD3 -by- COMT -by-EC; p = .004) and 2-way interactions ( COMT by EC; p = .002) were observed on Conners'-Teachers scores. Children with the COMT Met/Met genotype had lower scores at baseline and on placebo compared to the other genotype groups. Furthermore, stratifying the children according to their COMT genotypes helped to detect statistically significant and biologically meaningful effects of DRD3 genotype. CONCLUSIONS These findings suggest that COMT and DRD3 genetic variants may together play a role in ADHD symptomatology and response to treatment through gene-gene interaction.",2020,Children with the COMT Met/Met genotype had lower scores at baseline and on placebo compared to the other genotype groups.,"['Children with ADHD', '362 children with ADHD were assessed by parents and teachers during a week of baseline evaluation, followed by 1 week of']","['dopamine-related genes ( DRD3 and COMT ', 'MPH and placebo', 'placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],362.0,0.124173,Children with the COMT Met/Met genotype had lower scores at baseline and on placebo compared to the other genotype groups.,"[{'ForeName': 'Weam', 'Initials': 'W', 'LastName': 'Fageera', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}]",Journal of attention disorders,['10.1177/1087054720934191'] 2234,32564649,Preventing Relationship Abuse Among College Students: A Controlled Trial of the Skills for Healthy Adult Relationships ( SHARe ) Program.,"Intimate partner violence (IPV), which includes emotional, physical, and sexual violence in casual/dating and committed relationships, occurs at disproportionately high rates among college students. Prevention in college-age years is developmentally crucial, as college is associated with IPV risk. Relationship skills training has shown preliminary efficacy in decreasing IPV among college students. This article presents data from a controlled trial of Skills for Healthy Adult Relationships ( SHARe ), a weekly eight-session (12-hr) group program for college students, which aims to prevent interpersonal conflict and IPV through enhancing positive communication, reducing negative communication, promoting positive relationship attitudes, and strengthening ability to self-regulate in interpersonal contexts. Sixty-two college students (54.8% female) were allocated to the SHARe group or a wait-list control by randomizing to condition and then reassigning some individuals to control based on schedule availability to attend groups. Participants completed self-report measures of positive and negative communication, interpersonal confidence, and perpetration of physical, emotional, psychological, injurious, and sexual violence at baseline, post-group, and at a 3-month follow-up. At baseline, participants reported low levels of recent severe IPV perpetration, but controls reported higher levels of emotional abuse. Analyses controlled for baseline IPV. SHARe participants reported significantly higher confidence in their ability to manage conflicts at post-intervention and significantly lower psychological aggression at the follow-up compared with wait-listed controls. At the 3-month follow-up, self-reported perpetration of psychological abuse was 1.5 times higher for wait-list controls versus SHARe participants. The findings indicate that SHARe can help college students improve their interpersonal skills and develop healthy, non-abusive relationships.",2020,SHARe participants reported significantly higher confidence in their ability to manage conflicts at post-intervention and significantly lower psychological aggression at the follow-up compared with wait-listed controls.,"['Sixty-two college students (54.8% female', 'College Students', 'Healthy Adult Relationships ( SHARe ', 'Healthy Adult Relationships ( SHARe ) Program', 'college students', 'college-age years']","['Relationship skills training', 'SHARe group or a wait-list control by randomizing to condition and then reassigning some individuals to control based on schedule availability to attend groups']","['psychological aggression', 'levels of emotional abuse', 'self-report measures of positive and negative communication, interpersonal confidence, and perpetration of physical, emotional, psychological, injurious, and sexual violence', 'Intimate partner violence (IPV', 'psychological abuse']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",62.0,0.0205357,SHARe participants reported significantly higher confidence in their ability to manage conflicts at post-intervention and significantly lower psychological aggression at the follow-up compared with wait-listed controls.,"[{'ForeName': 'Aliya R', 'Initials': 'AR', 'LastName': 'Webermann', 'Affiliation': 'University of Maryland, Baltimore County, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': 'University of Maryland, Baltimore County, USA.'}, {'ForeName': 'Rupsha', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'University of Maryland, Baltimore County, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Schacht', 'Affiliation': 'University of Maryland, Baltimore County, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520933033'] 2235,32564661,Transcutaneous electrical nerve stimulation is superior than placebo and control for postoperative pain relief.,"Aim: To determine whether transcutaneous electrical nerve stimulation (TENS) is more efficient than placebo TENS and control groups for pain relief. Design: Randomized, single-blinded, placebo-controlled trial.  Setting & participants:  A total of 78 adults with postoperative pain, after cholecystectomy, at the University Hospital. They were randomized into active TENS, placebo TENS and control. Intervention: A total of 30-min interventions applied in the first 24 h after the surgery. Outcome: Pain intensity. Results: Pain significantly decreased for both TENS, however the active TENS was better. A decrease of 2 points or more on the visual analog scale for 53.8% active TENS and 11.5% placebo. Conclusion: There was a greater reduction in pain of important clinical relevance in the active TENS group. Clinical Trial registration: Brazilian Clinical Trial (REBEC): RBR-6cgx2k.",2020,"Pain significantly decreased for both TENS, however the active TENS was better.","['78 adults with postoperative pain, after cholecystectomy, at the University Hospital', 'Setting & participants']","['placebo TENS', 'Transcutaneous electrical nerve stimulation', 'active TENS, placebo TENS and control', 'transcutaneous electrical nerve stimulation (TENS', 'placebo']","['Pain', 'Pain intensity', 'visual analog scale', 'postoperative pain relief', 'pain of important clinical relevance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",78.0,0.564169,"Pain significantly decreased for both TENS, however the active TENS was better.","[{'ForeName': 'Maraísa Rodrigues', 'Initials': 'MR', 'LastName': 'Borges', 'Affiliation': 'Department of Applied Physiotherapy, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Nuno Miguel Lopes', 'Initials': 'NML', 'LastName': 'de Oliveira', 'Affiliation': 'Medical School, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Izabella Barberato Silva', 'Initials': 'IBS', 'LastName': 'Antonelli', 'Affiliation': 'Department of Applied Physiotherapy, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Maristella Borges', 'Initials': 'MB', 'LastName': 'Silva', 'Affiliation': 'The study was performed at Clinics Hospital of the Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Crema', 'Affiliation': 'Medical School, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Luciane Fernanda Rodrigues Martinho', 'Initials': 'LFRM', 'LastName': 'Fernandes', 'Affiliation': 'Medical School, Federal University of Triangulo Mineiro, Uberaba, MG, Brazil.'}]",Pain management,['10.2217/pmt-2019-0063'] 2236,32564940,How to improve adherence the captors of phosphorus on hemodialysis: Experience in real life with sucroferric oxyhydroxide.,"INTRODUCTION The lack of adherence to phosphate -binders (PB) is the most important factor in not achieving the objectives of serum phosphorus (sP). Studies in the real-world population are needed to understand the influence of PBs on adherence and how to modify it. METHODS Prospective study conducted during 3 months in usual clinical practice. Out of 105 hemodialysis patients, 57 were switched to SFOH and 48 maintained their baseline treatment (control group). sP levels and the percentage of patients with sP levels <5mg/dl were compared. Adherence before and after introduction of SFOH, number of pills of PB, preferences in the administration mode and side effects were analyzed. RESULTS The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS). The average of daily tablets decreased significantly in the SFOH group (7.2-2.3 comp, p<0.001), but not in the control group (5.6-5.6, p=NS) and 100% of the patients used only one PB in SFOH group. The use of SFOH increased the adherence according to the SMAQ questionnaire (57.8-84.3%; OR 13.1, p<0.001). The possibility to choose the preferred mode of administration (split-swallowing 89% compared to chewing 11%), improved the acceptance (44.7-78%). 14% of the patients experienced side effects and in 5.2% SFOH was discontinued for this reason. CONCLUSIONS SFOH controlled serum sP in 93% of patients, 100% in monotherapy, and with fewer tablets. The exploration and adaptation of preferences in the mode of administration influenced the acceptance of the drug by the patient and, probably, the future adherence.",2020,"The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS).","['Prospective study conducted during 3 months in usual clinical practice', '105 hemodialysis patients, 57 were switched to SFOH and 48 maintained their baseline treatment (control group']","['sucroferric oxyhydroxide', 'SFOH']","['sP levels', 'side effects', 'average of daily tablets', 'acceptance']","[{'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",105.0,0.0183717,"The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS).","[{'ForeName': 'M Dolores', 'Initials': 'MD', 'LastName': 'Arenas Jiménez', 'Affiliation': 'Nephrology Department, Hospital Vithas Perpetuo Internacional, Alicante, Spain; Nephrolgy Department, Hospital del Mar, Barcelona, Spain. Electronic address: lola@olemiswebs.com.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Navarro González', 'Affiliation': 'Nephrology Department, Hospital Universitario Nuestra Señora de la Candelaria, RedinRen, Santa Cruz de Tenerife, Spain.'}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2020.04.011'] 2237,32564965,Fibrin sealant reduces need for transfusions after hip hemiarthroplasty for femoral neck fractures.,"INTRODUCTION Every year more than 300,000 proximal femur fractures are diagnosed. Their number will double within 30 years. In femoral neck fractures treated with hip hemiarthroplasty 90-days mortality is 29.5-51.6%. Among complications increasing postoperative mortality, there is haemorrhage. Transfusion rate in these patients ranges from 25.7% to 39%. Blood transfusions expose to complications. Fibrin sealants are useful in reducing perioperative need for transfusions, total blood loss, blood loss from drainage. The aim of this study is to assess whether the use of a fibrin sealant during hip hemiarthroplasty implant reduces the need for transfusion. PATIENT AND METHODS All patients admitted with a proximal femur fracture from September 2018 to May 2019 were reviewed. Inclusion criteria were: femoral neck fracture AO 31B2-3, hip hemiarthroplasty. Exclusion criteria were: previous surgery on the affected hip, coagulation disorders, hematopoietic disorders. Patients were divided in fibrin sealant group and control group. All patients underwent partial hip replacement through a posterolateral approach. 4 ml of fibrin sealant (EVICEL, Omrix Biopharmaceuticals, Diegem, Belgium) were sprayed on the soft tissues of patients included in the fibrin sealant group. Primary outcome of our study was need for perioperative transfusion. Secondary outcomes were: mean red blood cell transfused volume, variations in haematocrit and haemoglobin and total blood volume loss. RESULTS Eighty-one consecutive patients were enrolled. EVICEL was used on 19 patients, standard haemostatic care on 62 patients. Two patients were transfused in the fibrin sealant group, 22 in the control group (p 0,0371). Mean transfused volume was 21,05 ml in the fibrin sealant group and 116,16 ml in the control group (p 0,0017). No significant difference could be found in haematocrit and haemoglobin variation and total blood loss. DISCUSSION A reduction in transfusional need with the use of a fibrin sealants was reported in studies on total hip arthroplasty and was confirmed by our study. CONCLUSION EVICEL reduces need for transfusion in patients undergoing hip hemiarthroplasty for a femoral neck fracture. It must be held among the options when a stricter control on transfusional requirement is needed.",2020,"CONCLUSION EVICEL reduces need for transfusion in patients undergoing hip hemiarthroplasty for a femoral neck fracture.","['Inclusion criteria were: femoral neck fracture AO 31B2-3, hip hemiarthroplasty', '19 patients, standard haemostatic care on 62 patients', 'patients undergoing hip hemiarthroplasty for a femoral neck fracture', 'Eighty-one consecutive patients were enrolled', 'All patients admitted with a proximal femur fracture from September 2018 to May 2019 were reviewed', 'Exclusion criteria were: previous surgery on the affected hip, coagulation disorders, hematopoietic disorders', 'transfusions after hip hemiarthroplasty for femoral neck fractures']","['fibrin sealant (EVICEL, Omrix Biopharmaceuticals, Diegem, Belgium', 'fibrin sealant', 'Fibrin sealants', 'fibrin sealants', 'partial hip replacement through a posterolateral approach', 'Fibrin sealant', 'EVICEL']","['haematocrit and haemoglobin variation and total blood loss', 'Transfusion rate', 'Mean transfused volume', 'mean red blood cell transfused volume, variations in haematocrit and haemoglobin and total blood volume loss', 'perioperative need for transfusions, total blood loss, blood loss', 'perioperative transfusion']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0186196', 'cui_str': 'Insertion of prosthesis or prosthetic device of femoral head'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0429890', 'cui_str': 'Total blood volume'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",81.0,0.027205,"CONCLUSION EVICEL reduces need for transfusion in patients undergoing hip hemiarthroplasty for a femoral neck fracture.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Sircana', 'Affiliation': 'UOC Ortopedia e Traumatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cauteruccio', 'Affiliation': 'UOC Ortopedia e Traumatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.'}, {'ForeName': 'Maria Serena', 'Initials': 'MS', 'LastName': 'Oliva', 'Affiliation': 'UOC Ortopedia e Traumatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma. Electronic address: mariaserena.oliva@gmail.com.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Piccirillo', 'Affiliation': 'UOC Emotrasfusione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pesare', 'Affiliation': 'UOC Ortopedia e Traumatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Minutillo', 'Affiliation': 'UOC Ortopedia e Traumatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ziranu', 'Affiliation': 'UOC Ortopedia e Traumatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.'}]",Injury,['10.1016/j.injury.2020.05.026'] 2238,32564996,A heart failure themed escape room approach to enhance pharmacy student learning.,"INTRODUCTION The purpose of this study was to design, pilot, and evaluate the efficacy of an educational escape room to enhance second professional year doctor of pharmacy students' knowledge of heart failure medicinal chemistry, pharmacology, and therapeutics in an integrated Modular Organ Systems Therapeutics (MOST) course and to assess students' perceptions of the game. METHODS Heart failure pharmacology, medicinal chemistry, and pharmacotherapeutics were taught in MOST prior to the escape room activity. Students were randomized into groups of approximately eight. At the completion of the activity, students were asked to fill out a perceptions survey. A follow up survey of their perceptions was again administered four weeks after the activity. RESULTS One-hundred-ninety-three students participated in the escape room activity. Overall, performance indicated that the escape room satisfactorily reinforced students' learning of the course material. Students expressed satisfaction toward the escape room activity on both surveys, with response rates of 92.22% and 56.99% for the initial and follow up surveys, respectively. Findings revealed no statistically significant differences between the first and the second group of responses, confirming that positive attitudes toward the activity did not alter over time. Students' satisfaction levels were inversely related to their grade point average (r = -0.20, p = 0.05). CONCLUSIONS Positive student perceptions reported immediately after the completion of the escape room activity and measured in the follow-up survey demonstrated that the escape room is a satisfying learning activity that can engage all students.",2020,"Students' satisfaction levels were inversely related to their grade point average (r = -0.20, p = 0.05). ","[""students' perceptions of the game"", 'One-hundred-ninety-three students participated in the escape room activity']",[],"[""Students' satisfaction levels""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",193.0,0.0124084,"Students' satisfaction levels were inversely related to their grade point average (r = -0.20, p = 0.05). ","[{'ForeName': 'Roda', 'Initials': 'R', 'LastName': 'Plakogiannis', 'Affiliation': 'Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, 1 University Plaza, Brooklyn, NY 11201, United States. Electronic address: roda.plakogiannis@liu.edu.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Stefanidis', 'Affiliation': ""Department of Management, Peter J. Tobin College of Business, St. John's University, 101 Astor Place, New York, NY 10003, United States. Electronic address: stefania@stjohns.edu.""}, {'ForeName': 'Nubriel', 'Initials': 'N', 'LastName': 'Hernandez', 'Affiliation': 'State University of New York (SUNY) Downstate Medical Center, 450 Clarkson Ave., Brooklyn, NY 11203, United States. Electronic address: nubriel.hernandez@downstate.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nogid', 'Affiliation': 'Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, 1 University Plaza, Brooklyn, NY 11201, United States. Electronic address: anna.nogid@liu.edu.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2020.04.014'] 2239,32565008,Measuring Apathy in Alzheimer's Disease in the Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): A Comparison of Instruments.,"BACKGROUND Diagnostic criteria for apathy have been published but have yet to be evaluated in the context of clinical trials. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) operationalized the diagnostic criteria for apathy (DCA) into a clinician-rated questionnaire informed by interviews with the patient and caregiver. OBJECTIVE The goal of the present study was to compare the classification of apathy using the DCA with that using the Neuropsychiatric Inventory-apathy (NPI-apathy) subscale in ADMET 2. Comparisons between NPI-Apathy and Dementia Apathy Interview Rating (DAIR) scale, and DCA and DAIR were also explored. METHODS ADMET 2 is a randomized, double-blind, placebo-controlled phase III trial examining the effects of 20 mg/day methylphenidate on symptoms of apathy over 6 months in patients with mild to moderate Alzheimer's disease (AD). Participants scoring at least 4 on the NPI-Apathy were recruited. This analysis focuses on cross-sectional correlations between baseline apathy scale scores using cross-tabulation. RESULTS Of 180 participants, the median age was 76.5 years and they were predominantly white (92.8%) and male (66.1%). The mean (±standard deviation) scores were 7.7 ± 2.4 on the NPI-apathy, and 1.9 ± 0.5 on the DAIR. Of those with NPI-defined apathy, 169 (93.9%, 95% confidence interval [CI] 89.3%-96.9%) met DCA diagnostic criteria. The DCA and DAIR overlapped on apathy diagnosis for 169 participants (93.9%, 95% CI 89.3%-96.9%). CONCLUSION The measurements used for the assessment of apathy in patients with AD had a high degree of overlap with the DCA. The NPI-apathy cut-off used to determine apathy in ADMET 2 selects those likely to meet DCA criteria.",2020,"Of those with NPI-defined apathy, 169 (93.9%, 95% confidence interval [CI] 89.3%-96.9%) met DCA diagnostic criteria.","['patients with AD had a high degree of overlap with the DCA', 'median age was 76.5 years and they were predominantly white (92.8%) and male (66.1', '180 participants', ""patients with mild to moderate Alzheimer's disease (AD"", 'Participants scoring at least 4 on the NPI-Apathy were recruited']","['methylphenidate', 'placebo']","['mean (±standard deviation) scores', 'Neuropsychiatric Inventory-apathy (NPI-apathy) subscale', 'NPI-Apathy and Dementia Apathy Interview Rating (DAIR) scale, and DCA and DAIR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",180.0,0.254169,"Of those with NPI-defined apathy, 169 (93.9%, 95% confidence interval [CI] 89.3%-96.9%) met DCA diagnostic criteria.","[{'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada. Electronic address: krista.lanctot@sunnybrook.ca.'}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Vieira', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Hamadou', 'Initials': 'H', 'LastName': 'Coulibaly', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'University Hospital - Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'University of Arkansas for Medical Science, Central Arkansas Veterans Healthcare System, Little Rock, AR.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Brawman-Mintzer', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, SC.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'van Dyck', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Anton P', 'Initials': 'AP', 'LastName': 'Porsteinsson', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Levey', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Burke', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, AZ.""}, {'ForeName': 'Jacobo E', 'Initials': 'JE', 'LastName': 'Mintzer', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, SC.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.020'] 2240,32565067,Smartphone-Based Therapeutic Exercises for Men Affected by Premature Ejaculation: A Pilot Study.,"INTRODUCTION Smartphone-delivered healthcare interventions allow patients to access services on demand when needed, improving motivation and compliance. However, the use of mobile health apps has been scarcely explored in sexual medicine. AIM To evaluate the effects of integrating psychological treatment for premature ejaculation (PE) with a mobile coaching app that offers therapeutic exercises on the patient's smartphone. METHODS This study comprised 35 heterosexual men with primary psychogenic PE (mean age 34 years, standard deviation = 9.15). All patients entered a cycle of 15 sessions of psychodynamic psychotherapy integrating behavioral therapy, each lasting about 45 minutes. The patients were randomly assigned to 2 groups, each of which performed daily homework exercises (physiotherapy exercises for reinforcing the pelvic floor muscles and cognitive exercises for distancing from sexual failure.) The first group (15 patients) received verbal and printed instructions only (treatment as usual-TAU), whereas the second group (17 patients) experienced the exercises with guidance from the mobile app (app). In both groups, the exercises started after the seventh session. Patients were advised to perform the exercises 3 times a day for 3 months. MAIN OUTCOME MEASURES The primary outcome measures were the Premature Ejaculation Diagnostic Tool and the Premature Ejaculation Profile. RESULTS Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01). The frequency of patients with no-PE condition for the app group after treatment was significantly higher than the frequency of patients with no-PE condition for the TAU group (P < .001). CONCLUSION Results suggest that a mobile coaching app performs better than TAU in improving both the behavioral skills of ejaculatory delay and sexual self-confidence within a psychological treatment for PE. Future studies should collect follow-up data and explore the potential of mobile coaching apps in combined pharmacotherapy and psychotherapy interventions. Optale G, Burigat S, Chittaro L. et al. Smartphone-Based Therapeutic Exercises for Men Affected by Premature Ejaculation: A Pilot Study. J Sex Med 2020;XX:XXX-XXX.",2020,"RESULTS Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01).","['35 heterosexual men with primary psychogenic PE (mean age 34 years, standard deviation\xa0=\xa09.15', 'premature ejaculation (PE', 'Men Affected by Premature Ejaculation']","['integrating psychological treatment', 'Smartphone-Based Therapeutic Exercises', 'TAU', 'verbal and printed instructions only (treatment as usual-TAU', 'exercises with guidance from the mobile app (app', 'homework exercises (physiotherapy exercises for reinforcing the pelvic floor muscles and cognitive exercises for distancing from sexual failure', 'psychodynamic psychotherapy integrating behavioral therapy', 'Smartphone-delivered healthcare interventions']","['behavioral skills of ejaculatory delay and sexual self-confidence', 'Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores', 'frequency of patients with no-PE condition', 'Premature Ejaculation Diagnostic Tool and the Premature Ejaculation Profile']","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0458006', 'cui_str': 'Psychogenic'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",35.0,0.0387204,"RESULTS Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Optale', 'Affiliation': 'Male and Female Sexual Dysfunctions Center of the Regione Veneto, ASL3, Mestre-Venezia, Italy. Electronic address: optale.gabriele@gmail.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Burigat', 'Affiliation': 'HCI Lab, Department of Mathematics, Computer Science, and Physics, Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Chittaro', 'Affiliation': 'HCI Lab, Department of Mathematics, Computer Science, and Physics, Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Riva', 'Affiliation': 'Applied Technology for Neuro-Psychology Lab, IRCCS Istituto Auxologico Italiano, Milan, Italy; Department of Psychology, Università Cattolica del Sacro Cuore, Milan, Italy.'}]",Sexual medicine,['10.1016/j.esxm.2020.05.003'] 2241,32565070,"Efficacy of Carbohydrate Supplementation Compared With Bolus Insulin Dose Reduction Around Exercise in Adults With Type 1 Diabetes: A Retrospective, Controlled Analysis.","OBJECTIVES Individuals with type 1 diabetes try to manage the risk of exercise-induced hypoglycemia by either pre-exercise/pre-meal bolus insulin dose reductions and/or consuming additional carbohydrates during exercise. Both strategies have proven to be effective in offsetting hypoglycemia, but it remains unclear which one is more beneficial. The aim of this study was to assess the efficacy of carbohydrate supplementation vs bolus insulin dose reduction in prevention of hypoglycemia during moderate-intensity exercise in those with type 1 diabetes. METHODS This investigation was a retrospective, controlled analysis of 2 independent clinical trials. All participants performed continuous, moderate-intensity cycle ergometer exercise for ∼45 minutes. Two therapy management groups and a control group were compared. Group A was supplemented with 15 to 30 g carbohydrates at a glycemic threshold of 7.0 mmol/L during exercise, group B reduced their individual bolus insulin dose by 50% with their last meal before exercise and group C served as a control. RESULTS No hypoglycemic events occurred in group A, whereas 4 events were recorded in groups B (p=0.02) and C (p=0.02). CONCLUSIONS Carbohydrate supplementation was superior to bolus insulin reduction for prevention of hypoglycemia during exercise in people with type 1 diabetes.",2020,"No hypoglycemic events occurred in group A, whereas 4 events were recorded in groups B (p=0.02) and C (p=0.02). ","['people with type 1 diabetes', 'Individuals with type 1 diabetes', 'those with type 1 diabetes', 'Adults With Type 1 Diabetes']","['exercise-induced hypoglycemia by either pre-exercise/pre-meal bolus insulin dose reductions and/or consuming additional carbohydrates during exercise', 'carbohydrates at a glycemic threshold of 7.0 mmol/L during exercise, group B reduced their individual bolus insulin dose by 50% with their last meal before exercise and group C served as a control', 'Carbohydrate supplementation', 'Carbohydrate Supplementation', 'Bolus Insulin Dose Reduction Around Exercise', 'carbohydrate supplementation vs bolus insulin']",['hypoglycemic events'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}]","[{'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0357351,"No hypoglycemic events occurred in group A, whereas 4 events were recorded in groups B (p=0.02) and C (p=0.02). ","[{'ForeName': 'Max L', 'Initials': 'ML', 'LastName': 'Eckstein', 'Affiliation': 'Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'McCarthy', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Norbert J', 'Initials': 'NJ', 'LastName': 'Tripolt', 'Affiliation': 'Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Exercise Physiology, Training and Training Therapy Research Group, Institute of Sports Science, University of Graz, Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Birnbaumer', 'Affiliation': 'Exercise Physiology, Training and Training Therapy Research Group, Institute of Sports Science, University of Graz, Graz, Austria.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Pferschy', 'Affiliation': 'Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hofmann', 'Affiliation': 'Exercise Physiology, Training and Training Therapy Research Group, Institute of Sports Science, University of Graz, Graz, Austria.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bracken', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sourij', 'Affiliation': 'Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria; Zayed Center for Health Sciences, United Arab Emirates University, United Arab Emirates.'}, {'ForeName': 'Othmar', 'Initials': 'O', 'LastName': 'Moser', 'Affiliation': 'Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria. Electronic address: othmar.moser@medunigraz.at.'}]",Canadian journal of diabetes,['10.1016/j.jcjd.2020.03.003'] 2242,32565073,A single dose of doxycycline after an Ixodes ricinus tick bite to prevent Lyme borreliosis: an open-label randomized controlled trial.,"OBJECTIVES A single dose of doxycycline after a tick bite can prevent the development of Lyme borreliosis in North America, but extrapolation to Europe is hampered by differences in Borrelia burgdorferi sensu lato genospecies and tick species. We assessed the efficacy of prophylaxis after a tick bite in Europe. METHODS We conducted an open-label randomized controlled trial, administering a single dose of 200 mg doxycycline within 72 hours after removing an attached tick from the skin, compared to no treatment. Potential participants ≥ 8 years of age who reported a recent tick bite online were invited for the study. After informed consent, they were randomly assigned to either the prophylaxis or the no-treatment group. Participants in the prophylaxis group were asked to visit their general practitioner to administer the antibiotics. All participants were followed up by online questionnaires. Our primary outcome was the development of physician-confirmed Lyme borreliosis in a modified-intention-to-treat analysis. This study is registered in the Netherlands Trial Register (NTR3953) and is closed. RESULTS Between April 11, 2013, and June 10, 2015, 3538 potential participants were randomized, of whom 1689 were included in the modified-intention-to-treat analysis. 10 cases of Lyme borreliosis were reported out of 1041 participants (0•96 %) in the prophylaxis group, and 19 cases out of 648 no-treatment participants (2•9 %), resulting in a relative risk reduction of 67% (95% CI 31 - 84%), and a number-needed-to-treat of 51 (95% CI 29 - 180). No serious adverse events were reported. CONCLUSIONS This primary care-based trial provides evidence that a single dose of doxycycline can prevent the development of Lyme borreliosis after an Ixodes ricinus tick bite.",2020,"No serious adverse events were reported. ","['Potential participants ≥ 8 years of age who reported a recent tick bite online were invited for the study', 'Lyme borreliosis in North America', '3538 potential participants were randomized, of whom 1689 were included in the modified-intention-to-treat analysis', 'Between April 11, 2013, and June 10, 2015']",['doxycycline'],"['serious adverse events', 'development of physician-confirmed Lyme borreliosis', 'Lyme borreliosis', 'relative risk reduction']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0241407', 'cui_str': 'Tick bite'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024198', 'cui_str': 'Lyme disease'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0024198', 'cui_str': 'Lyme disease'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",3538.0,0.190912,"No serious adverse events were reported. ","[{'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Harms', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: margriet.harms@rivm.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hofhuis', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: agnetha.hofhuis@rivm.nl.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sprong', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: hein.sprong@rivm.nl.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Bennema', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: sitabennema@hotmail.com.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ferreira', 'Affiliation': 'National Institute for Public Health and the Environment, Department of Statistics, Informatics and Mathematical Modeling, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: jose.ferreira@rivm.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fonville', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: manoj.fonville@rivm.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Docters van Leeuwen', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: arieke.docters.van.leeuwen@rivm.nl.'}, {'ForeName': 'W J J', 'Initials': 'WJJ', 'LastName': 'Assendelft', 'Affiliation': 'Radboud University Medical Center, Department of Primary and Community Care, PO box 9101, 6500 HB Nijmegen, the Netherlands. Electronic address: Pim.Assendelft@radboudumc.nl.'}, {'ForeName': 'H C P M', 'Initials': 'HCPM', 'LastName': 'Van Weert', 'Affiliation': 'Amsterdam University Medical Center, Department of Primary Care, PO box 22660, 1100 DD Amsterdam, the Netherlands. Electronic address: h.c.vanweert@amc.uva.nl.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Van Pelt', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: wilfrid.van.pelt@rivm.nl.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Van den Wijngaard', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: kees.van.den.wijngaard@rivm.nl.'}]",The Journal of infection,['10.1016/j.jinf.2020.06.032'] 2243,32565092,Effects of a transitional care programme for individuals with limbs disabilities living in a rural community: A randomized controlled trial.,"BACKGROUND Transitional care (TC) has been proven to be effective in addressing fragmented care and preventing adverse outcomes for chronically ill patients transitioning from hospital to home, but the definitive description of TC that was used successfully for individuals with limbs disability has not been formed in the context of health care reform in China. OBJECTIVE The aim of this study was to evaluate the effect of a TC programme on health outcomes in individuals with limbs disability based on an original community for healthcare. METHOD It was a randomized controlled trial. Individuals in the intervention group received ongoing rehabilitation both at the specialized care center and at home through multidisciplinary team, while individuals in the control group received routine follow-up visits by primary healthcare physicians. Outcomes were measured by Short-Form Health Survey-36 (SF-36), Modified Barthel Index (MBI) and Caregiver Strain Index (CSI) at 3 and 6 months respectively. RESULTS A total of 84 participants were randomly assigned (intervention n = 42, control n = 42). Mean values of Physical Components Summary, an integral component of SF-36, was significantly better in the intervention group at 3 and 6 months (42.0 ± 2.3 and 44.3 ± 1.5 respectively). The same trend was observed in MBI (72.2 ± 6.8 and 78.6 ± 9.3 at 3 and 6 months respectively). But the significant improvement in CSI was only observed at 6 months. There were significant differences between groups in these scores except Mental Components Summary. CONCLUSION The TC programme has been proven to be feasible and improve health-related outcomes.",2020,"Mean values of Physical Components Summary, an integral component of SF-36, was significantly better in the intervention group at 3 and 6 months (42.0 ± 2.3 and 44.3 ± 1.5 respectively).","['individuals with limbs disabilities living in a rural community', 'chronically ill patients transitioning from hospital to home', 'individuals with limbs disability based on an original community for healthcare', '84 participants']","['TC programme', 'transitional care programme', 'ongoing rehabilitation both at the specialized care center and at home through multidisciplinary team, while individuals in the control group received routine follow-up visits by primary healthcare physicians']","['MBI (72.2\xa0±', 'CSI', 'Mean values of Physical Components Summary, an integral component of SF-36', 'health outcomes', 'Short-Form Health Survey-36 (SF-36), Modified Barthel Index (MBI) and Caregiver Strain Index (CSI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",84.0,0.113925,"Mean values of Physical Components Summary, an integral component of SF-36, was significantly better in the intervention group at 3 and 6 months (42.0 ± 2.3 and 44.3 ± 1.5 respectively).","[{'ForeName': 'Aiwen', 'Initials': 'A', 'LastName': 'Deng', 'Affiliation': 'Department of Rehabilitation, Nanhai Hospital, Southern Medical University, Foshan, China; General Practice Center, Nanhai Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Yakai', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Nanhai Hospital, Southern Medical University, Foshan, China; General Practice Center, Nanhai Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Ribo', 'Initials': 'R', 'LastName': 'Xiong', 'Affiliation': 'Department of Rehabilitation, Nanhai Hospital, Southern Medical University, Foshan, China; General Practice Center, Nanhai Hospital, Southern Medical University, Foshan, China. Electronic address: xiongribo@outlook.com.'}]",Disability and health journal,['10.1016/j.dhjo.2020.100946'] 2244,32565127,Comparison of Overall Survival Between De Novo and Secondary Acute Lymphoblastic Leukemia Patients of Different Ages.,"PURPOSE To compare the overall survival (OS) between de novo and secondary acute lymphoblastic leukemia (ALL) patients in different age groups after chemotherapy. PATIENTS AND METHODS Data from 8305 ALL patients undergoing chemotherapy from the Surveillance, Epidemiology, and End Results (SEER) database during 1975 to 2015 were included in this study, of which 7454 (80.11%) were in the de novo ALL group, and 851 (19.89%) were in the secondary ALL (sALL) group. Propensity matching was used before comparison of OS between the two groups. RESULTS Female ALL patients had a lower risk of death than male (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.88-0.98; P < .01). The mortality of black patients was higher than in white patients (HR, 1.29; 95% CI, 1.18-1.42; P < .001). Patients aged 45-75 years (HR, 1.82; 95% CI, 1.72-1.94; P < .001) and ≥ 75 years (HR, 3.85; 95% CI, 3.52-4.23; P < .001) had a higher risk of death. Separated/divorced (HR, 1.21; 95% CI, 1.10-1.34; P < .001) and widowed (HR, 1.35; 95% CI, 1.21-1.51; P < .001) patients had a higher risk of death than single patients. sALL patients had a higher risk of death than de novo ALL patients (HR, 1.21; 95% CI, 1.12-1.30; P < .001). The mean age of the de novo ALL group was lower than in the sALL group (51.05 vs. 60.25; P < .001) after the propensity score was matched, and the 1-, 2-, 3-, 4-, and 5-year OS of the de novo ALL group were higher than that of the sALL group aged 18-75 years (P < .001). CONCLUSION The survival rate of ALL decreased with increased age. Patients with sALL had poorer OS than de novo patients aged 18-75 years.",2020,"ALL group were higher than that of the sALL group aged 18-75 years (P < .001). ","['de novo and secondary acute lymphoblastic leukemia (ALL) patients in different age groups after chemotherapy', 'Data from 8305 ALL patients undergoing chemotherapy from the Surveillance, Epidemiology, and End Results (SEER) database during 1975 to 2015 were included in this study, of which 7454 (80.11%) were in the de novo ALL group, and 851 (19.89%) were in the secondary ALL (sALL) group', 'Acute Lymphoblastic Leukemia Patients of Different Ages']",['sALL'],"['risk of death', 'mortality of black patients', '5-year OS of the de novo', 'Overall Survival', 'poorer OS', 'overall survival (OS', 'survival rate of ALL']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]",,0.200058,"ALL group were higher than that of the sALL group aged 18-75 years (P < .001). ","[{'ForeName': 'Jiansheng', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Hematology, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China. Electronic address: jianshengz123@163.com.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Laboratory, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.04.013'] 2245,32565133,Final Overall Survival Analysis of the SOGUG Phase 2 MAJA Study: Maintenance Vinflunine Versus Best Supportive Care After First-Line Chemotherapy in Advanced Urothelial Carcinoma.,"INTRODUCTION The MAJA study compared vinflunine (VFL) plus best supportive care (BSC) maintenance therapy versus BSC alone in advanced urothelial carcinoma responsive to first-line chemotherapy. The primary end point of progression-free survival was achieved. We present the final overall survival (OS) and long-term follow-up safety analyses. PATIENTS AND METHODS Patients were enrolled, and a subsequent post hoc analysis was performed on the basis of radiologic response or stabilization to first-line cisplatin/gemcitabine (CG) chemotherapy (4-6 cycles), according to Response Evaluation Criteria in Solid Tumors (RECIST). VFL + BSC versus BSC alone were randomly assigned until disease progression. RESULTS At final analysis, 58 patients (66.7%) had died while 29 (33.3%) had survived; the BSC arm had higher mortality (VFL + BSC, n = 26, 59.1% vs. BSC, n = 32, 74.4%). Median follow-up of surviving patients was 38.8 months (interquartile range, 23.8-61.6). Median OS was 16.7 months (95% confidence interval, 0-34.5) in VFL and 13.2 months (95% confidence interval, 6-20.4) in the BSC groups (hazard ratio, 0.736; 95% confidence interval, 0.44-1.24, P = .182). Post hoc group division did not affect median OS in either study arm. CONCLUSION Final analysis supported a benefit of VFL in maintenance therapy in patients with disease control after first-line treatment with CG, with no unexpected long-term adverse effects. The study was insufficiently powered to show a significant OS advantage.",2020,"Median OS was 16.7 months (95% confidence interval, 0-34.5) in VFL and 13.2 months (95% confidence interval, 6-20.4) in the BSC groups (hazard ratio, 0.736; 95% confidence interval, 0.44-1.24, P = .182).","['Patients were enrolled', 'Advanced Urothelial Carcinoma']","['vinflunine (VFL) plus best supportive care (BSC) maintenance therapy versus BSC alone', 'stabilization to first-line cisplatin/gemcitabine (CG) chemotherapy', 'VFL', 'First-Line Chemotherapy', 'VFL\xa0+ BSC versus BSC']","['Median OS', 'final overall survival (OS', 'median OS', 'progression-free survival', 'higher mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C0672663', 'cui_str': 'vinflunine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.176591,"Median OS was 16.7 months (95% confidence interval, 0-34.5) in VFL and 13.2 months (95% confidence interval, 6-20.4) in the BSC groups (hazard ratio, 0.736; 95% confidence interval, 0.44-1.24, P = .182).","[{'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt Molins', 'Affiliation': 'Medical Oncology, Hospital del Mar, Barcelona, Spain; Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. Electronic address: jbellmunt@imim.es.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'García-Donas Jiménez', 'Affiliation': 'Medical Oncology, HM Hospitales, Centro Integral Oncológico HM Clara Campal, Madrid, Spain.'}, {'ForeName': 'Begoña P', 'Initials': 'BP', 'LastName': 'Valderrama', 'Affiliation': 'Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Virizuela Echaburu', 'Affiliation': 'Medical Oncology, Hospital Universitario Virgen de Macarena, Sevilla, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Hernando-Polo', 'Affiliation': 'Medical Oncology, Hospital Universitario Fundación Alcorcón, Alcorcón, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Climent Durán', 'Affiliation': 'Medical Oncology, Instituto Valenciano de Oncología, Valencia, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Villa-Guzmán', 'Affiliation': 'Medical Oncology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'José Ángel', 'Initials': 'JÁ', 'LastName': 'Arranz Arija', 'Affiliation': 'Medical Oncology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Mar Llorente', 'Initials': 'ML', 'LastName': 'Ostiategui', 'Affiliation': 'Medical Oncology, Hospital General Universitario de Elda, Alicante, Spain.'}, {'ForeName': 'Nuria Laínez', 'Initials': 'NL', 'LastName': 'Milagro', 'Affiliation': 'Medical Oncology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Aránzazu', 'Initials': 'A', 'LastName': 'González-Del-Alba', 'Affiliation': 'Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Begoña Mellado', 'Initials': 'BM', 'LastName': 'González', 'Affiliation': 'Medical Oncology Department, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Enrique Gallardo', 'Initials': 'EG', 'LastName': 'Díaz', 'Affiliation': ""Oncology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain.""}, {'ForeName': 'Daniel Castellano', 'Initials': 'DC', 'LastName': 'Gauna', 'Affiliation': 'Medical Oncology, CIBER-ONC, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Montserrat Domènech', 'Initials': 'MD', 'LastName': 'Santasusana', 'Affiliation': 'Medical Oncology, Althaia, Xarxa Assitencial de Manresa, Manresa, Spain.'}, {'ForeName': 'Urbano Anido', 'Initials': 'UA', 'LastName': 'Herranz', 'Affiliation': 'Medical Oncology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Xavier García', 'Initials': 'XG', 'LastName': 'Del Muro Solans', 'Affiliation': ""Medical Oncology, Institut Català d'Oncologia Hospitalet, IDIBELL, Universitat de Barcelona, Hospitalet de Llobregat, Spain.""}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Pérez-Gracia', 'Affiliation': 'Medical Oncology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Javier Puente', 'Initials': 'JP', 'LastName': 'Vázquez', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Morales-Barrera', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Albert Font', 'Initials': 'AF', 'LastName': 'Pous', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology, Badalona Applied Research Group in Oncology (B∙ARGO), IGTP, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2020.05.004'] 2246,32565318,Impact of Sequencing of Androgen Suppression and Radiotherapy on Testosterone Recovery in Localized Prostate Cancer.,"PURPOSE We performed a secondary analysis of a phase III randomized trial to determine the influence of sequencing of radiotherapy and ADT on post-treatment testosterone recovery and implications of testosterone recovery on subsequent relapse. METHODOLOGY Localized prostate cancer patients with Gleason score ≤7, clinical stage T1b-T3a, and prostate-specific antigen <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate radiotherapy (NHT arm) or concurrent and adjuvant ADT for 6 months starting simultaneously with radiotherapy (CAHT arm). Full testosterone recovery (FTR) was defined as recovery of testosterone to >10.5 nmol/L in patients with baseline ≥10.5 nmol/L or to baseline level in patients with baseline <10.5 nmol/L. Restricted mean survival time (RMST) since ADT initiation to supra-castrate testosterone level (>1.7 nmol/L) and FTR was compared between the arms using a truncation time point of 36 months. RESULTS The adjusted difference in RMST to supra-castrate testosterone between the CAHT and NHT arm was 1.5 months (95% CI: 0.5 to 2.5, p=0.005). No difference was noted in RMST to FTR between the arms (18.7 versus 18.5 months, adjusted difference: 0.5, 95% CI: -1.4 to 2.4, p=0.61). There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT. Based on a multi-state Markov model, no independent effect of time to FTR on risk of subsequent relapse was observed (adjusted hazard ratio: 1.02, 95%CI: 0.96-1.08). CONCLUSION Patients should be counselled that after treatment with prostate radiotherapy and 6 months of ADT, it needs on average an additional 12 months for the FTR to occur. This is independent of the sequencing of ADT and radiotherapy. Furthermore, recovery of testosterone does not appear to impact the risk of subsequent relapse.",2020,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"['Localized prostate cancer patients with Gleason', 'Localized Prostate Cancer']","['neoadjuvant and concurrent ADT', 'prostate radiotherapy (NHT arm) or concurrent and adjuvant ADT', 'Androgen Suppression and Radiotherapy', 'radiotherapy and ADT', 'prostate radiotherapy']","['RMST to FTR', 'mean survival time (RMST) since ADT initiation to supra-castrate testosterone level', 'RMST to supra-castrate testosterone', 'risk of subsequent relapse', 'risk of relapse', 'Full testosterone recovery (FTR', 'score ≤7, clinical stage T1b-T3a, and prostate-specific antigen', 'recovery of testosterone']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0475390', 'cui_str': 'Tumor stage T3a'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",,0.251948,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"[{'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA; Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; Department of Radiology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; Department of Radiology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Morgan', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; Department of Radiology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; Department of Radiology, University of Ottawa, Ottawa, ON, Canada. Electronic address: smalone@toh.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.017'] 2247,32565319,Efficacy of dose-escalated chemoradiation on complete tumour response in patients with locally advanced rectal cancer (RECTAL-BOOST); a phase 2 randomised controlled trial.,"PURPOSE Pathological complete tumour response following chemoradiation in patients with locally advanced rectal cancer (LARC) is associated with favourable prognosis and allows organ-sparing treatment strategies. We aimed to investigate the effect of an external radiation boost to the tumour prior to chemoradiation on pathological or sustained clinical complete tumour response in LARC. METHODS AND MATERIALS This multicentre, non-blinded, phase 2, randomised controlled trial followed the trials within cohorts-design, which is a pragmatic trial design allowing cohort participants to be randomized for an experimental intervention. Patients in the intervention group are offered the intervention (and can accept or refuse this), whereas patients in the control group are not notified about the randomisation. Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of two radiotherapy centres were eligible. Patients were randomised to no boost or an external radiation boost (5 x 3 Gy) without concurrent chemotherapy directly followed by standard pelvic chemoradiation (25 x 2 Gy with concurrent capecitabine). The primary outcome was pathological complete response (pCR, i.e. ypT0N0) in patients with planned surgery at 12 weeks or, as surrogate for pCR, a 2-year sustained clinical complete response for patients treated with an organ preservation strategy. Analyses were intention to treat. The study was registered with ClinicalTrials.gov, number NCTXXXXXX. RESULTS Between Sept 2014 and July 2018, 128 patients were randomised. Fifty-one of the 64 (79.7%) patients in the intervention group accepted and received a boost. Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively). Rate of pathological or sustained clinical complete tumour response was similar between the groups: 23 of 64 (35.9%, 95%CI 24.3-48.9) in the intervention group versus 24 of 64 (37.5%, 95%CI 25.7-50.5) in the control group (OR=0.94 95%CI 0.46-1.92). Near-complete or complete tumour regression was more common in the intervention group: 34 of 49 (69.4%) versus 24 of 53 (45.3%) in the control group (OR=2.74, 95%CI 1.21-6.18). Grade >3 acute toxicity was comparable: 6 of 64 (9.4%) in the intervention group versus 5 of 64 (7.8%) in the control group (OR=1.22 95%CI 0.35-4.22). CONCLUSION Dose escalation with an external radiotherapy boost to the tumour prior to neoadjuvant chemoradiation did not increase the pathological or sustained clinical complete tumour response rate in LARC.",2020,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","['patients with locally advanced rectal cancer (RECTAL-BOOST', 'Between Sept 2014 and July 2018, 128 patients were randomised', 'patients with locally advanced rectal cancer', 'Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of two radiotherapy centres were eligible']","['external radiation boost', 'external radiotherapy', 'external radiation boost (5 x 3 Gy) without concurrent chemotherapy directly followed by standard pelvic chemoradiation (25 x 2 Gy with concurrent capecitabine', 'dose-escalated chemoradiation']","['Rate of pathological or sustained clinical complete tumour response', 'pathological complete response (pCR, i.e. ypT0N0', 'cN2-stage', 'complete tumour response', 'cT4-stage and a low rectal tumour', 'Grade >3 acute toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",128.0,0.233842,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Couwenberg', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: A.M.Couwenberg@umcutrecht.nl.'}, {'ForeName': 'Johannes P M', 'Initials': 'JPM', 'LastName': 'Burbach', 'Affiliation': 'Department of Surgery, Medical Center Leeuwarden, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Berbee', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Miangela M', 'Initials': 'MM', 'LastName': 'Lacle', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Arensman', 'Affiliation': 'Department of Pathology, Meander Medical Centre, Amersfoort, the Netherlands.'}, {'ForeName': 'Mihaela G', 'Initials': 'MG', 'LastName': 'Raicu', 'Affiliation': 'Department of Pathology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Wessels', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Verdult', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Roodhart', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Onne', 'Initials': 'O', 'LastName': 'Reerink', 'Affiliation': 'Department of Radiation Oncology, Insala Clinic, Zwolle, the Netherlands.'}, {'ForeName': 'Sieske', 'Initials': 'S', 'LastName': 'Hoendervangers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Buijsen', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Grabsch', 'Affiliation': 'Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre+, Maastricht, the Netherlands and Pathology & Data Analytics.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'Esther Cj', 'Initials': 'EC', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, the Netherlands; Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Anke B', 'Initials': 'AB', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Joost T', 'Initials': 'JT', 'LastName': 'Heikens', 'Affiliation': 'Department of Surgery, Hospital Rievierenland, Tiel, the Netherlands.'}, {'ForeName': 'Ane L', 'Initials': 'AL', 'LastName': 'Appelt', 'Affiliation': ""Radiotherapy Research Group, Leeds Institute of Medicine at St James's, University of Leeds, Leeds, UK; Leeds Cancer Centre, St James University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht, the Netherlands; Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Martijn P W', 'Initials': 'MPW', 'LastName': 'Intven', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.013'] 2248,32571327,Twelve months of exercise training did not halt abdominal aortic calcification in patients with CKD - a sub-study of RENEXC-a randomized controlled trial.,"BACKGROUND Arteriosclerosis is prevalent in patients with chronic kidney disease (CKD). Our aims were to investigate (1) the effects of 12 months of either balance- or strength- both in combination with endurance training on abdominal aortic calcification (AAC); on some lipids and calcific- and inflammatory markers; and (2) the relationships between the change in AAC score and these markers in non-dialysis dependent patients with CKD stages 3 to 5. METHODS One hundred twelve patients (mean age 67 ± 13 years), who completed 12 months of exercise training; comprising either balance- or strength training, both in combination with endurance training; with a measured glomerular filtration rate (mGFR) 22.6 ± 8 mL/min/1.73m 2 , were included in this study. AAC was evaluated with lateral lumbar X-ray using the scoring system described by Kauppila. Plasma fetuin-A, fibroblast growth factor 23 (FGF23) and interleukin 6 (IL6) were measured with Enzyme-linked immunosorbent assay (ELISA) kits. RESULTS After 12 months of exercise training, the AAC score increased significantly in both groups; mGFR and lipoprotein (a) decreased significantly in both groups; parathyroid hormone (PTH) and 1,25(OH) 2 D 3 increased significantly only in the strength group; fetuin-A increased significantly only in the balance group. Plasma triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, FGF23, phosphate, calcium, IL6, C-reactive protein (CRP), albumin were unchanged. The increase in AAC score was positively related to ageing and the levels of baseline triglycerides and lipoprotein (a). CONCLUSIONS Exercise training did not prevent the progression of AAC; it might have contributed to the reduced levels of lipoprotein (a) and unchanged levels of calcific- and inflammatory markers in these patients with non-dialysis dependent CKD. Hypertriglyceridemia, high levels of lipoprotein (a) and ageing emerged as longitudinal predictors of vascular calcification in these patients. TRIAL REGISTRATION NCT02041156 at www.ClinicalTrials.gov. Date of registration: January 20, 2014. Retrospectively registered.",2020,"After 12 months of exercise training, the AAC score increased significantly in both groups; mGFR and lipoprotein (a) decreased significantly in both groups; parathyroid hormone (PTH) and 1,25(OH) 2 D 3 increased significantly only in the strength group; fetuin-A increased significantly only in the balance group.","['One hundred twelve patients (mean age 67\u2009±\u200913\u2009years), who completed 12\u2009months of exercise training; comprising either balance- or strength training, both in combination with endurance training; with a measured glomerular filtration rate (mGFR) 22.6\u2009±\u20098\u2009mL/min/1.73m 2 , were included in this study', 'patients with chronic kidney disease (CKD', 'patients with CKD - a sub-study of']","['exercise training', 'balance- or strength- both in combination with endurance training', 'Exercise training', 'RENEXC']","['levels of baseline triglycerides\xa0and lipoprotein (a', 'Plasma triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, FGF23, phosphate, calcium, IL6, C-reactive protein (CRP), albumin', 'Hypertriglyceridemia, high levels of lipoprotein (a', 'parathyroid hormone (PTH) and 1,25(OH) 2 D 3', 'abdominal aortic calcification', 'Plasma fetuin-A, fibroblast growth factor 23 (FGF23) and interleukin 6 (IL6', 'AAC score', 'progression of AAC', 'abdominal aortic calcification (AAC']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0882903,"After 12 months of exercise training, the AAC score increased significantly in both groups; mGFR and lipoprotein (a) decreased significantly in both groups; parathyroid hormone (PTH) and 1,25(OH) 2 D 3 increased significantly only in the strength group; fetuin-A increased significantly only in the balance group.","[{'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hellberg', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hellmark', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Department of Laboratory Medicine, Division of Clinical Chemistry & Pharmacology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Clyne', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden. Naomi.Clyne@med.lu.se.'}]",BMC nephrology,['10.1186/s12882-020-01881-y'] 2249,32571329,Impact of modified short-term fasting and its combination with a fasting supportive diet during chemotherapy on the incidence and severity of chemotherapy-induced toxicities in cancer patients - a controlled cross-over pilot study.,"BACKGROUND This pilot trial aimed to investigate whether modified short-term fasting (mSTF) reduces the incidence of chemotherapy-induced toxicities and whether an initial ketogenic diet (KD) as fasting supportive diet reduces fasting-related discomfort and improves the compliance. METHODS In this controlled cross-over trial, gynaecologic cancer patients undergoing chemotherapy with a minimum of 4 cycles fasted for 96 h during half of their chemotherapy cycles and consumed a normocaloric diet during the other chemotherapy cycles. The caloric intake during mSTF was restricted to 25% of each patient's daily requirement. In addition, half of the patients should eat a 6-day normocaloric KD prior to each mSTF period to investigate a KD's hunger-suppression effect. Chemotherapy-induced toxicities, fasting-related discomfort, body composition, quality of life, laboratory values, and compliance were assessed at each chemotherapy. RESULTS Thirty patients aged 30-74 years (median 54 years) completed the study. During mSTF the frequency and severity score of stomatitis [- 0.16 ± 0.06; 95% CI -0.28 - (- 0.03); P = 0.013], headaches [- 1.80 ± 0.55; 95% CI -2.89 - (- 0.71); P = 0.002], weakness [- 1.99 ± 0.87; 95% CI -3.72 - (- 0.26); P = 0.024] and the total toxicities' score were significantly reduced [- 10.36 ± 4.44; 95% CI -19.22 - (- 1.50); P = 0.023]. We also observed significantly fewer chemotherapy postponements post-mSTF, reflecting improved tolerance of chemotherapy [- 0.80 ± 0.37; 95% CI -1.53 - (- 0.06); P = 0.034]. A significant reduction in mean body weight by - 0.79 ± 1.47 kg during mSTF was not compensated and remained until study's conclusion (P < 0.005). On average, Insulin [- 169.4 ± 44.1; 95% CI -257.1 - (- 81.8); P < 0.001] and Insulin-like growth factor 1 levels [- 33.3 ± 5.4; 95% CI -44.1 - (- 22.5); P < 0.001] dropped significantly during fasting. The KD as a fasting supportive diet neither reduced fasting-related discomfort nor improved compliance of our fasting regimen. CONCLUSION MSTF is safe and feasible in gynaecologic cancer patients. Our results indicate that mSTF during chemotherapy can reduce chemotherapy-induced toxicities and enhance the tolerance of chemotherapy. Larger clinical trials are required to recommend mSTF for cancer patients. TRIAL REGISTRATION germanctr.de: DRKS00011610, registered 30 January, 2017.",2020,A significant reduction in mean body weight by - 0.79 ± 1.47 kg during mSTF was not compensated and remained until study's conclusion (P < 0.005).,"['Thirty patients aged 30-74\u2009years (median 54\u2009years) completed the study', 'cancer patients ', 'cancer patients', 'gynaecologic cancer patients undergoing chemotherapy with a minimum of 4\u2009cycles fasted for 96\u2009h during half of their', 'gynaecologic cancer patients']","['mSTF', 'modified short-term fasting (mSTF', 'MSTF', 'modified short-term fasting and its combination with a fasting supportive diet during chemotherapy', 'initial ketogenic diet (KD', 'chemotherapy cycles and consumed a normocaloric diet']","['caloric intake', 'Insulin-like growth factor 1 levels', 'Chemotherapy-induced toxicities, fasting-related discomfort, body composition, quality of life, laboratory values, and compliance', 'mean body weight', 'headaches', ""total toxicities' score"", 'incidence and severity of chemotherapy-induced toxicities']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",30.0,0.158937,A significant reduction in mean body weight by - 0.79 ± 1.47 kg during mSTF was not compensated and remained until study's conclusion (P < 0.005).,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Zorn', 'Affiliation': 'Department of Medicine I, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Ehret', 'Affiliation': 'Department of Medicine I, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schäuble', 'Affiliation': 'Department of Medicine I, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Rautenberg', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Medical Center - University of Freiburg, Faculty of Gynecology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ihorst', 'Affiliation': 'Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Bertz', 'Affiliation': 'Department of Medicine I, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. hartmut.bertz@uniklinik-freiburg.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Urbain', 'Affiliation': 'Department of Medicine I, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Raynor', 'Affiliation': 'Department of Medicine I, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",BMC cancer,['10.1186/s12885-020-07041-7'] 2250,32571394,Correction to: Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['severely ill COVID-19 patients with anti-interleukin drugs (COV-AID'],[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]",[],[],,0.0761701,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart N', 'Initials': 'BN', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04519-4'] 2251,32571395,Clinical efficacy evaluation of a traditional Miao technique of crossbow needle therapy in the treatment of knee osteoarthritis: a multi-center randomized controlled trial.,"BACKGROUND Knee osteoarthritis (KOA) seriously reduces quality of life and is a major threat to the health of the middle-aged and elderly. This study aimed to assess the efficacy of Miao crossbow needle therapy vs. acupuncture for KOA therapy. METHODS This multicenter, randomized controlled trial was performed at three hospitals between April 2016 and December 2016. The patients were randomized to receive crossbow needle (CN) or acupuncture (AT). All treatments were completed within 46 days. Evaluation of treatment was conducted on the 46th, 62nd, and 77th days. The primary endpoint was change of Western Ontario and McMaster Osteoarthritis Index (WOMAC) score on the 46th day. The secondary endpoints included WOMAC score, the Lysholm knee score, the Japanese Orthopedic Association (JOA) knee score, visual analog scale (VAS), and the MOS 36-item short-form health survey (SF-36), on the 46th, 62nd, and 77th day. RESULTS Finally, data of 301 participants were analyzed for the efficacy of treatment. Compared with AT, there was a larger change of WOMAC score in the CN group after treatment [- 25.0 (95% CI - 27.0, - 23.0) vs. - 18.8 (95% CI - 20.8, - 16.9), P < 0.001]. In the CN group, the WOMAC score was lower at all three time points (P = 0.008, P = 0.003, P < 0.001 respectively), while the Lysholm knee score (P = 0.03) and JOA score (P = 0.013) were higher and the VAS score (P = 0.011) was lower on the 77th day. CONCLUSION Both Miao crossbow needle therapy and acupuncture reduced the WOMAC score. Miao crossbow needle therapy can be an alternative method for treating patients with knee osteoarthritis. TRIAL REGISTRATION ChiCTR, ChiCTR-INR-16008032. Registered on 12 March 2016.",2020,"In the CN group, the WOMAC score was lower at all three time points (P = 0.008, P = 0.003, P < 0.001 respectively), while the Lysholm knee score (P = 0.03) and JOA score (P = 0.013) were higher and the VAS score (P = 0.011) was lower on the 77th day. ","['knee osteoarthritis', '301 participants', 'three hospitals between April 2016 and December 2016', 'patients with knee osteoarthritis']","['Miao crossbow needle therapy', 'crossbow needle (CN) or acupuncture (AT', 'Miao crossbow needle therapy vs. acupuncture', 'traditional Miao technique of crossbow needle therapy']","['WOMAC score', 'VAS score', 'WOMAC score, the Lysholm knee score, the Japanese Orthopedic Association (JOA) knee score, visual analog scale (VAS), and the MOS 36-item short-form health survey (SF-36), on the 46th, 62nd, and 77th day', 'JOA score', 'change of Western Ontario and McMaster Osteoarthritis Index (WOMAC) score', 'Lysholm knee score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scoring Scale'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",301.0,0.0792543,"In the CN group, the WOMAC score was lower at all three time points (P = 0.008, P = 0.003, P < 0.001 respectively), while the Lysholm knee score (P = 0.03) and JOA score (P = 0.013) were higher and the VAS score (P = 0.011) was lower on the 77th day. ","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine, Guiyang, 550000, China.'}, {'ForeName': 'Hong-Cai', 'Initials': 'HC', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, 100700, China.'}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Xiao-Fang', 'Initials': 'XF', 'LastName': 'Yang', 'Affiliation': 'No.2 Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, 550000, China.'}, {'ForeName': 'Wei-Wei', 'Initials': 'WW', 'LastName': 'Guo', 'Affiliation': 'Chinese Medicine Hospital of Qiandongnan Miao and Dong Autonomous Prefecture, Kaili, 556000, China.'}, {'ForeName': 'Chun-Xia', 'Initials': 'CX', 'LastName': 'Lu', 'Affiliation': 'No.1 Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, 550000, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine, Guiyang, 550000, China. 516260179@qq.com.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China. wangyanping4816@163.com.'}]",Trials,['10.1186/s13063-020-04508-7'] 2252,32571396,"Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.","BACKGROUND Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes. However, studies, so far, have employed supervised resistance exercise in a laboratory or gym facility which limits the future translation of such exercise in to clinical practice and recommendations. Our primary aim, therefore, is to test the hypothesis, in a randomized controlled trial, that home-based resistance exercise training and gym-based resistance exercise training both reduce HbA1c levels in people with type 2 diabetes compared to control. We will also investigate the effects of home- and gym-based resistance exercise training on muscle strength and body composition. METHODS The current study is a three-arm randomised controlled trial which will be conducted with 150 eligible people with type 2 diabetes to compare home-and gym-based resistance exercise training with usual care in Kuwait. The interventions will be delivered by exercise specialists and last for 32 weeks. The primary outcomes are HbA1c with secondary outcomes measuring muscle function, body composition, physical activity and quality of life. DISCUSSION Ethical approval has been granted by the Dasman Diabetes Institute ethical review committee (RA/197/2019). Study findings will be disseminated through presentation at scientific conferences and in scientific journals. TRIAL REGISTRATION NCT04136730: Retrospectively registered on 21 October 2019.",2020,"BACKGROUND Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes.","['150 eligible people with type 2 diabetes to compare home-and gym-based', 'people with type 2 diabetes']","['home- and gym-based resistance exercise training', 'resistance exercise training with usual care in Kuwait', 'resistance exercise training and gym-based resistance exercise training']","['HbA1c with secondary outcomes measuring muscle function, body composition, physical activity and quality of life', 'glycated haemoglobin (HbA1c', 'muscle strength and body composition', 'glycaemic control, body composition and muscle strength', 'HbA1c levels']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.141422,"BACKGROUND Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes.","[{'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al Ozairi', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dalal', 'Initials': 'D', 'LastName': 'Alsaeed', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Taliping', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Jalali', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'El Samad', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mashankar', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Etab', 'Initials': 'E', 'LastName': 'Taghadom', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Guess', 'Affiliation': 'Medical Division, Dasman Diabetes Institute, P.O.Box 1180, Dasman, Kuwait.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Gray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK. stuart.gray@glasgow.ac.uk.'}]",Trials,['10.1186/s13063-020-04480-2'] 2253,32571414,Endoscopic myringoplasty: comparison of double layer cartilage-perichondrium graft and single fascia grafting.,"OBJECTIVE To compare surgical results of endoscopic myringoplasty using double layer cartilage-perichondrium grafts versus single fascia grafts. STUDY DESIGN Prospective, randomized, controlled. SETTING University-affiliated teaching hospital. SUBJECTS AND METHODS In total,134 patients who underwent endoscopic myringoplasty were included in this study. Patients in group A received a double layer tragal cartilage-perichondrium graft and those in group B received a temporal muscle fascia graft. The groups were compared with respect to the pre- and postoperative air-bone gap (ABG) and the graft success rate. RESULTS The graft success rate was 98.5% (66/67) in the Group A and 94.0% (63/67) in the Group B at 6 months, the difference wasn't statistically significant (p = 0.362). However, the graft success rate was 97.0% (65/67) in the Group A and 85.1% (57/67) in the Group B at 12 months, the difference was statistically significant (p = 0.034). In addition, only one patient (1.49%) had small keratin pearls in the Group A, no patients developed cholesteatoma of middle ear in either group. CONCLUSIONS The endoscopic double layer perichondrium-cartilage graft technique is feasible for repairing medium or larger perforations, it has a better long-term graft success rate and less operative time compared with the single layer fascia graft technique. However, long-term hearing outcomes were the same for the single and double layer closure techniques.",2020,"The endoscopic double layer perichondrium-cartilage graft technique is feasible for repairing medium or larger perforations, it has a better long-term graft success rate and less operative time compared with the single layer fascia graft technique.","['University-affiliated teaching hospital', 'total,134 patients who underwent endoscopic myringoplasty']","['double layer cartilage-perichondrium graft and single fascia grafting', 'Endoscopic myringoplasty', 'endoscopic myringoplasty using double layer cartilage-perichondrium grafts', 'double layer tragal cartilage-perichondrium graft and those in group B received a temporal muscle fascia graft']","['small keratin pearls', 'cholesteatoma of middle ear', 'graft success rate', 'pre- and postoperative air-bone gap (ABG) and the graft success rate']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0225361', 'cui_str': 'Perichondrium'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185473', 'cui_str': 'Grafting of fascia'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C4049579', 'cui_str': 'Keratin pearl'}, {'cui': 'C0155490', 'cui_str': 'Cholesteatoma of middle ear'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}]",,0.104745,"The endoscopic double layer perichondrium-cartilage graft technique is feasible for repairing medium or larger perforations, it has a better long-term graft success rate and less operative time compared with the single layer fascia graft technique.","[{'ForeName': 'Zheng Cai', 'Initials': 'ZC', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, the affiliated Yiwu hospital of Wenzhou medical university (Yiwu central Hospital), 699 jiangdong road, Yiwu city, 322000, Zhejiang provice, China. louzhengcai@163.com.'}]",Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale,['10.1186/s40463-020-00440-7'] 2254,32571428,Correction to: Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC'],['Sargramostim'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0216231', 'cui_str': 'sargramostim'}]",[],,0.0795117,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart N', 'Initials': 'BN', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04520-x'] 2255,32571429,Timing of antiretroviral therapy for HIV-infected patients with moderate to severe Pneumocystis pneumonia: study protocol for a multi-centre prospective randomised controlled trial.,"BACKGROUND Pneumocystis pneumonia (PCP) is a common acquired immune deficiency syndrome (AIDS)-related opportunistic infection. Recent reports estimate that more than 400,000 patients with human immunodeficiency virus (HIV) develop PCP each year globally. However, the timing of antiretroviral therapy (ART) initiation for HIV-infected patients with PCP is still controversial, and the benefits and risks of early initiation of ART are not completely clear. We thus designed this study in order to determine the optimal timing for ART initiation for HIV-positive patients with moderate to severe PCP. METHODS This study will be an open-label, multi-centre, prospective randomised controlled trial. A total of 200 subjects will be randomly assigned to an early ART initiation group (≤14 days after PCP diagnosis) and a deferred ART initiation group (>14 days after PCP diagnosis) at a 1:1 ratio. All subjects will be followed up for 48 weeks after starting ART. The primary endpoint is incidence of disease progression (including new or relapsing opportunistic infections and death) at week 48. The secondary endpoints are the changes in CD4 counts from baseline at weeks 12, 24 and 48; the degree of virological suppression (HIV RNA < 50 copies/mL) at weeks 24 and 48; the rate of development of PCP-associated immune reconstitution inflammatory syndrome; and adverse events over 48 weeks. DISCUSSION We hope that the results of this study will reveal the optimal timing for initiation of ART in HIV-infected patients with moderate to severe PCP. TRIAL REGISTRATION This trial was registered as one of the 12 trials under the name of a general project at chictr.org.cn on February 1, 2019. The registration number of the general project is ChiCTR1900021195.",2020,"The secondary endpoints are the changes in CD4 counts from baseline at weeks 12, 24 and 48; the degree of virological suppression (HIV RNA < 50 copies/mL) at weeks 24 and 48; the rate of development of PCP-associated immune reconstitution inflammatory syndrome; and adverse events over 48 weeks. ","['HIV-infected patients with moderate to severe PCP', 'HIV-positive patients with moderate to severe PCP', '400,000 patients with human immunodeficiency virus (HIV', 'HIV-infected patients with moderate to severe Pneumocystis pneumonia', '12 trials under the name of a general project at chictr.org.cn on February 1, 2019', '200 subjects']","['early ART initiation', 'deferred ART initiation', 'antiretroviral therapy']","['incidence of disease progression (including new or relapsing opportunistic infections and death', 'degree of virological suppression', 'rate of development of PCP-associated immune reconstitution inflammatory syndrome; and adverse events', 'changes in CD4 counts']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1535939', 'cui_str': 'Pneumocystosis'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1535939', 'cui_str': 'Pneumocystosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1619738', 'cui_str': 'Immune reconstitution inflammatory syndrome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",200.0,0.3825,"The secondary endpoints are the changes in CD4 counts from baseline at weeks 12, 24 and 48; the degree of virological suppression (HIV RNA < 50 copies/mL) at weeks 24 and 48; the rate of development of PCP-associated immune reconstitution inflammatory syndrome; and adverse events over 48 weeks. ","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Harypursat', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Shengquan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China.'}, {'ForeName': 'Yaokai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, 109 Baoyu Road, Shapingba District, Chongqing, China. yaokaichen@hotmail.com.'}]",Trials,['10.1186/s13063-020-04450-8'] 2256,32571432,The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France.,"BACKGROUND Suicide constitutes a cause of death which could be prevented by e-health programs accessible to the general population. Effective promotion has the potential to maximize the uptake of such programs. However, few e-health programs have been combined with promotion campaigns. The primary objective of this trial is to assess the effectiveness of a tailored promotion, at a local level, of a mobile application and website offering evidence-based content for suicide prevention (the StopBlues program), and to compare the effectiveness of two types of local promotion in terms of their impact on suicidal acts. Secondary objectives focus on the effectiveness of the promotion in terms of the intensity of utilization of the StopBlues program, help-seeking behaviors and the level of psychological impairment of program users. METHODS/DESIGN This is a three-arm, parallel-group, cluster-randomized controlled trial, with before-and-after observation. Thirty-four clusters, corresponding to geographical areas sharing a common local authority in France, will be included. They will be randomly assigned to one of the following arms with a ratio of 1:1:1: a control group; a basic promotion group in which promotion of the StopBlues program will be done by local authorities; and an intensified promotion group in which basic promotion will be supplemented by an additional one in a general practitioner's waiting room. The primary outcome measure will be the number of suicidal acts within each cluster over a 12-month period following the launch of the intervention. Baseline data will be collected for each cluster over the 12-month period prior to the trial. Secondary outcomes will include length of use of the StopBlues program, measures of help-seeking behaviors and level of psychological distress among users of the program, as well as the cost-effectiveness and budgetary impact of its promotion. A more sustained promotion by local authorities will also be implemented after 12 months in the control group and assessed using the same outcome measures. DISCUSSION This research should contribute to the sparse evidence base regarding the promotion of e-health programs and will support the wider delivery of the intervention evaluated if proven effective. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03565562. Registered on 11 June 2018.",2020,"The primary objective of this trial is to assess the effectiveness of a tailored promotion, at a local level, of a mobile application and website offering evidence-based content for suicide prevention (the StopBlues program), and to compare the effectiveness of two types of local promotion in terms of their impact on suicidal acts.",['adult general population in France'],"[""control group; a basic promotion group in which promotion of the StopBlues program will be done by local authorities; and an intensified promotion group in which basic promotion will be supplemented by an additional one in a general practitioner's waiting room"", 'smartphone application and associated website']","['length of use of the StopBlues program, measures of help-seeking behaviors and level of psychological distress among users of the program, as well as the cost-effectiveness and budgetary impact of its promotion', 'suicidal behaviors', 'intensity of utilization of the StopBlues program, help-seeking behaviors and the level of psychological impairment of program users', 'number of suicidal acts']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]",,0.0737629,"The primary objective of this trial is to assess the effectiveness of a tailored promotion, at a local level, of a mobile application and website offering evidence-based content for suicide prevention (the StopBlues program), and to compare the effectiveness of two types of local promotion in terms of their impact on suicidal acts.","[{'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Gandré', 'Affiliation': 'Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France.'}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Le Jeannic', 'Affiliation': 'Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France.'}, {'ForeName': 'Marie-Amélie', 'Initials': 'MA', 'LastName': 'Vinet', 'Affiliation': 'Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Turmaine', 'Affiliation': 'Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Courtet', 'Affiliation': 'Department of Psychiatric Emergency and Acute Care, Lapeyronie Hospital, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Roelandt', 'Affiliation': 'Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Vaiva', 'Affiliation': 'Department of Adult Psychiatry, CHU Lille, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'INSERM CIC 1415, CHRU de Tours, Tours, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Alberti', 'Affiliation': 'Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Chevreul', 'Affiliation': 'Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France. karine.chevreul@urc-eco.fr.'}]",Trials,['10.1186/s13063-020-04464-2'] 2257,32571453,[Clinical effect of functional chewing training in treatment of oral motor dysfunction in children with cerebral palsy: a prospective randomized controlled clinical trial].,"OBJECTIVE To study the effect of functional chewing training (FuCT) on masticatory function, the severity of tongue thrust, and the severity and frequency of drooling in children with cerebral palsy. METHODS A prospective study was performed for 48 children who were diagnosed with oral motor dysfunction from January 2019 to January 2020, and they were randomly divided into an FuCT group and an oral motor training group, with 24 children in each group. Both groups received FuCT or oral motor training for 12 weeks, and then they were evaluated in terms of the changes in the masticatory function, the severity of tongue thrust, and the severity and frequency of drooling. RESULTS There were no significant differences between the two groups in the masticatory function, the severity of tongue thrust, and the severity and frequency of drooling before treatment (P>0.05). After the 12-week training, the FuCT group showed significant improvements in the masticatory function and the severity of tongue thrust and drooling (P<0.05), but with no improvement in the frequency of drooling (P>0.05), while the oral motor training group had no improvements in the masticatory function, the severity of tongue thrust, and the severity and frequency of drooling (P>0.05). After the 12-week training, the FuCT group had more significantly improvements in the severity of tongue thrust and the severity and frequency of drooling than the oral motor training group (P<0.05). CONCLUSIONS FuCT can effectively improve the masticatory function, the severity of tongue thrust, and the severity and frequency of drooling in children with cerebral palsy.",2020,"There were no significant differences between the two groups in the masticatory function, the severity of tongue thrust, and the severity and frequency of drooling before treatment (P>0.05).","['48 children who were diagnosed with oral motor dysfunction from January 2019 to January 2020', 'children with cerebral palsy']","['FuCT or oral motor training', 'oral motor training', 'FuCT', 'functional chewing training', 'functional chewing training (FuCT']","['masticatory function', 'severity of tongue thrust and the severity and frequency of drooling', 'frequency of drooling', 'oral motor dysfunction', 'masticatory function, the severity of tongue thrust, and the severity and frequency of drooling', 'masticatory function and the severity of tongue thrust and drooling']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1829460', 'cui_str': 'Tongue thrusting'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}]",48.0,0.0156327,"There were no significant differences between the two groups in the masticatory function, the severity of tongue thrust, and the severity and frequency of drooling before treatment (P>0.05).","[{'ForeName': 'Qiong-Li', 'Initials': 'QL', 'LastName': 'Fan', 'Affiliation': 'Department of Pediatrics, Second Affiliated Hospital, Army Medical University, Chongqing 400037, China. zhangyuping8888@qq.com.'}, {'ForeName': 'Zhi-Feng', 'Initials': 'ZF', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Xiu-Mei', 'Initials': 'XM', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Li-Shuang', 'Initials': 'LS', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'Li-Sha', 'Initials': 'LS', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Zhang', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[] 2258,32571614,Effects of diet and exercise on adipocytokine levels in patients with moderate to severe chronic kidney disease.,"BACKGROUND AND AIMS Obesity is a pro-inflammatory risk factor for progression of CKD and cardiovascular disease. We hypothesized that implementation of caloric restriction and endurance exercise would improve adipocytokine profiles in patients with moderate to severe CKD. METHODS AND RESULTS We enrolled patients with moderate to severe CKD through a multi-center pilot randomized trial of diet and exercise in a 4-arm design (dietary restriction of 10%-15% reduction in caloric intake, exercise three times/week, combined diet and exercise, and control) (NCT01150851). Adipocytokines (adiponectin and leptin) were measured at the beginning and end of the study period as secondary outcomes. Treatment effect was analyzed in a multivariable model adjusted for baseline outcome values, age, gender, site and diabetes. A total of 122 participants were consented, 111 were randomized (42% female, 25% diabetic, and 91% hypertensive), 104 started intervention and 92 completed the study (Figure 1). Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment. CONCLUSION Our data suggest that dietary caloric restriction increases plasma adiponectin levels in stage 3-4 CKD patients, with limited effect on leptin levels. These findings suggest the potential for improving the metabolic milieu of CKD with moderate calorie restriction.",2020,"Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment. ","['A total of 122 participants were consented, 111 were randomized (42% female, 25% diabetic, and 91% hypertensive), 104 started intervention and 92 completed the study (Figure\xa01', 'enrolled patients with moderate to severe CKD through a multi-center pilot randomized trial of', 'patients with moderate to severe CKD', 'patients with moderate to severe chronic kidney disease']","['diet and exercise', 'dietary caloric restriction', 'diet and exercise in a 4-arm design (dietary restriction of 10%-15% reduction in caloric intake, exercise three times/week, combined diet and exercise, and control) (NCT01150851', 'caloric restriction and endurance exercise']","['Adipocytokines (adiponectin and leptin', 'plasma adiponectin levels', 'adipocytokine levels', 'Plasma adiponectin levels', 'circulating leptin', 'adipocytokine profiles', 'leptin levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",122.0,0.0257898,"Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment. ","[{'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Aydemir', 'Affiliation': 'Hitit University Medical School, Nephrology Department, Corum, Turkey.'}, {'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Pike', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Aseel', 'Initials': 'A', 'LastName': 'Alsouqi', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Samuel A E', 'Initials': 'SAE', 'LastName': 'Headley', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA; Providence Medical Research Center, Providence Health Care, Spokane, WA, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Milch', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Kelsey A', 'Initials': 'KA', 'LastName': 'Moody', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Germain', 'Affiliation': 'Department of Nephrology, Bay State Medical Center, Springfield, MA, USA.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Lipworth', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Himmelfarb', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Ikizler', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Cassianne', 'Initials': 'C', 'LastName': 'Robinson-Cohen', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: cassianne.robinson-cohen@vumc.edu.""}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.012'] 2259,32571649,"Comparison of rate of orthodontic tooth movement in adolescent patients undergoing treatment by first bicuspid extraction and en-mass retraction, associated with low level laser therapy in passive self-ligating and conventional brackets: A randomized controlled trial.","BACKGROUND Low Level Laser Therapy (LLLT) is one of the various interventions to accelerate the rate of Orthodontic Tooth Movement (OTM) in adolescent patients who are undergoing en-mass retraction after all first bicuspid extractions. OBJECTIVES To assess the efficacy of LLLT in increasing the rate of OTM. MATERIALS AND METHODS Setting and sample population: Institutional Department of Orthodontics and Dentofacial Orthopaedics. Participants, study design and methods: 65 Patients requiring all first premolar extractions were randomly allocated to three groups. Two groups (Comprising of passive self-ligating brackets and conventional brackets) were treated with LLLT and one group served as the control (conventional brackets). The allocation ratio was 1:1:1.32. Eligibility criteria: adolescent patients with sound and healthy permanent dentition with Little's Irregularity Index<5mm. MAIN OUTCOME rate of tooth movement in mm/month. Randomization and blinding: computer-generated random allocation sequence; only the data analyser was blinded by coding the digital models. Patients were reviewed once every month till the completion of space closure. STATISTICS data normality was checked using Shapiro-Wilks test and Q-Q Plot. Parametric tests were applied for the inferential statistics (ANCOVA) with Dunnett's t test being used for post hoc analysis. RESULTS There was a statistically significant enhancement in the rate of OTM in the 2 experimental groups (0.68/0.67mm/month in the right and left side of the maxilla and 0.66/0.65mm/month in the right and left side of the mandible) when compared with the control group (0.48mm/month in the maxilla and 0.48mm/month in the mandible) (P<0.05), but when the 2 experimental groups were compared no difference was observed (P>0.05). No serious harms were reported. CONCLUSION A significant increase in the rate of OTM was observed with the application of LLLT. No difference was observed in the rate of OTM when comparing different ligation methods treated with LLLT. REGISTRATION National Trial Registry (CTRI No- CTRI/2018/04/013156). Protocol was not published before trial commencement.",2020,"There was a statistically significant enhancement in the rate of OTM in the 2 experimental groups (0.68/0.67mm/month in the right and left side of the maxilla and 0.66/0.65mm/month in the right and left side of the mandible) when compared with the control group (0.48mm/month in the maxilla and 0.48mm/month in the mandible) (P<0.05), but when the 2 experimental groups were compared no difference was observed (P>0.05).","['adolescent patients undergoing treatment by first bicuspid extraction and en-mass retraction, associated with low level laser therapy in passive self-ligating and conventional brackets', '65 Patients requiring all first premolar extractions', 'Setting and sample population: Institutional Department of Orthodontics and Dentofacial Orthopaedics', 'adolescent patients who are undergoing en-mass retraction after all first bicuspid extractions', ""Eligibility criteria: adolescent patients with sound and healthy permanent dentition with Little's Irregularity Index<5mm""]","['LLLT', 'Low Level Laser Therapy (LLLT', 'LLLT and one group served as the control (conventional brackets']","['rate of tooth movement in mm/month', 'rate of Orthodontic Tooth Movement (OTM', 'rate of OTM']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005373', 'cui_str': 'Bicuspid'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",65.0,0.0733495,"There was a statistically significant enhancement in the rate of OTM in the 2 experimental groups (0.68/0.67mm/month in the right and left side of the maxilla and 0.66/0.65mm/month in the right and left side of the mandible) when compared with the control group (0.48mm/month in the maxilla and 0.48mm/month in the mandible) (P<0.05), but when the 2 experimental groups were compared no difference was observed (P>0.05).","[{'ForeName': 'Hmar', 'Initials': 'H', 'LastName': 'Lalnunpuii', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Batra', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India.'}, {'ForeName': 'Sreevatsan', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Institute of Dental Studies and Technologies, NH58, Modinagar, UP, India. Electronic address: sreevatsanr32@gmail.com.'}]",International orthodontics,['10.1016/j.ortho.2020.05.008'] 2260,32571718,Safety and immunogenicity of three seasonal inactivated influenza vaccines among pregnant women and antibody persistence in their infants.,"OBJECTIVE Inactivated influenza virus vaccines (IIVs) are recommended for all pregnant women in the United States. We conducted a prospective, randomized, double blind study of three licensed seasonal trivalent IIVs (IIV3s) to assess their safety and immunogenicity in pregnant women and determine the level and persistence of passively transferred maternal antibody in infants. STUDY DESIGN 139 pregnant women ages 18-39 years and 14-33 weeks' gestation, and 44 non-pregnant women, were randomized 1:1:1 to receive a single intramuscular dose of one of three licensed IIV3s (Agriflu®, Fluzone®, or Fluarix®) prior to the 2010-2011 influenza season. Reactogenicity, adverse events (AEs) and pregnancy outcomes were documented. Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays were collected prior to and 28 and 180 days after immunization. Maternal sera and cord blood were collected at the time of delivery and sera were obtained from 44 infants at 6 weeks of age. RESULTS Pregnant and non-pregnant women experienced similar frequency of injection site (92% and 86%, respectively) and systemic (95% and 87%, respectively) reactions, the majority of which were mild. There were no vaccine-associated maternal or infant serious AEs. Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women. The ratios of cord blood (infant) to maternal HAI antibody titers at delivery ranged between 1.1 and 1.7 for each of the vaccine antigens. Influenza antibody concentrations in infants were 70-40% of the birth titer by 6 weeks of age. CONCLUSIONS The three IIV3s were well tolerated in pregnant women. Antibody responses were comparable in pregnant and non-pregnant women, and after second or third trimester vaccination. Transplacental transfer of maternal antibodies to the infant was efficient. However, antibody titers decline rapidly in the first 6 weeks of life.",2020,Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women.,"['infants were 70-40% of the birth titer by 6\xa0weeks of age', 'pregnant women and determine the level and persistence of passively transferred maternal antibody in infants', 'all pregnant women in the United States', ""139 pregnant women ages 18-39\xa0years and 14-33\xa0weeks' gestation, and 44 non-pregnant women"", 'pregnant women and antibody persistence in their infants', 'pregnant women']","['licensed IIV3s (Agriflu®, Fluzone®, or Fluarix®', 'licensed seasonal trivalent IIVs (IIV3s', 'influenza virus vaccines (IIVs', 'seasonal inactivated influenza vaccines']","['Influenza antibody concentrations', 'Safety and immunogenicity', 'Antibody responses', 'Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays', 'Reactogenicity, adverse events (AEs) and pregnancy outcomes', 'safety and immunogenicity', 'Maternal sera and cord blood', 'Transplacental transfer of maternal antibodies', 'frequency of injection site', 'ratios of cord blood (infant) to maternal HAI antibody titers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0591524', 'cui_str': 'fluarix'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0236493', 'cui_str': 'Influenza antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}]",139.0,0.0806985,Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women.,"[{'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Munoz', 'Affiliation': 'Department of Pediatrics, Houston, TX, United States; Department of Molecular Virology and Microbiology, Houston, TX, United States. Electronic address: florm@bcm.edu.'}, {'ForeName': 'Shital M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'Department of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jackson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics & Gynecology, Duke University, Durham, NC, United States.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Frey', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Carey R', 'Initials': 'CR', 'LastName': 'Petrie', 'Affiliation': 'The EMMES Company, LLC, Rockville, MD, United States.'}, {'ForeName': 'Eli A', 'Initials': 'EA', 'LastName': 'Sendra', 'Affiliation': 'The EMMES Company, LLC, Rockville, MD, United States.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Keitel', 'Affiliation': 'Department of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.05.059'] 2261,32571773,"Oseltamivir for coronavirus illness: post-hoc exploratory analysis of an open-label, pragmatic, randomised controlled trial in European primary care from 2016 to 2018.","BACKGROUND Patients infected with the novel coronavirus (SARS-CoV-2) are being treated empirically with oseltamivir, but there is little evidence from randomised controlled trials to support the treatment of coronavirus infections with oseltamivir. AIM To determine whether adding oseltamivir to usual care reduces time to recovery in symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2). DESIGN AND SETTING Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries. METHOD Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2), were randomised to usual care or usual care plus oseltamivir. The primary outcome was time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache. RESULTS Coronaviruses (CoV-229E, CoV-OC43, CoV-KU1 and CoV-NL63) were identified in 308 (9%) out of 3266 randomised participants in the trial; 153 of these were allocated to usual care and 155 to usual care plus oseltamivir; the primary outcome was ascertained in 136 and 147 participants, respectively. The median time to recovery was shorter in patients randomised to oseltamivir: 4 days (interquartile range [IQR] 3-6) versus 5 days (IQR 3-8; hazard ratio 1.31; 95% confidence interval = 1.03 to 1.66; P = 0.026). CONCLUSION Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone. This may be of relevance to the primary care management of COVID-19.",2020,"CONCLUSION Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","['Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2', 'Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2', 'coronavirus illness', 'Patients infected with the novel coronavirus (SARS-CoV-2', 'European primary care from 2016 to 2018', 'Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries', 'symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2']","['usual care plus oseltamivir', 'oseltamivir', 'Oseltamivir', 'usual care or usual care plus oseltamivir']","['time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache', 'median time to recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3266.0,0.207108,"CONCLUSION Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Centre for General Practice, Department of Family Medicine & Health Policy (FAMPOP); Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cianci', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants, Austin, Texas, US; adjunct assistant professor, Vanderbilt University, Department of Biostatistics, Nashville, Tennessee, US.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Muireann', 'Initials': 'M', 'LastName': 'de Paor', 'Affiliation': 'Department of General Practice, Royal College of Surgeons in Ireland School of Medicine, Dublin, Ireland.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Ieven', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711941'] 2262,32571846,Retraction: Greater analgesic effect with intermittent compared with continuous mode of lumbar plexus block for total hip arthroplasty: a randomized controlled trial.,,2020,,"['Retraction', 'total hip arthroplasty']",['lumbar plexus block'],['analgesic effect'],"[{'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",,0.0776811,,[],Regional anesthesia and pain medicine,['10.1136/rapm-2018-100091ret'] 2263,32571859,"The EX-FRAIL CKD trial: a study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease.","INTRODUCTION Frailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD. METHODS AND ANALYSIS The EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2). ETHICS AND DISSEMINATION Ethical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body. TRIAL REGISTRATION NUMBER ISRCTN87708989.",2020,"Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression.","['adults with chronic kidney disease (CKD', 'Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment', 'pre-frail and FRAIL, older adults with Chronic Kidney Disease', 'adults with CKD', 'prefrail and frail older adults with CKD']","['multicomponent home-based exercise programme', 'home-based EXercise programme', 'Exercise training', 'exercise or usual care', 'tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression']","['physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2', 'rate of recruitment, intervention adherence, outcome measure completion and participant attrition', 'quality of life (HRQOL), hospitalisation and mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.149749,"Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression.","[{'ForeName': 'Andrew Christopher', 'Initials': 'AC', 'LastName': 'Nixon', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK andrew.nixon3@nhs.net.'}, {'ForeName': 'Theodoros M', 'Initials': 'TM', 'LastName': 'Bampouras', 'Affiliation': 'Lancaster Medical School, Lancaster University, Lancaster, Lancashire, UK.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Gooch', 'Affiliation': 'Centre for Health Research and Innovation, NIHR Lancashire Clinical Research Facility, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}, {'ForeName': 'Hannah M L', 'Initials': 'HML', 'LastName': 'Young', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kenneth William', 'Initials': 'KW', 'LastName': 'Finlayson', 'Affiliation': 'Research in Childbirth and Health Unit, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Pendleton', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Brady', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}, {'ForeName': 'Ajay P', 'Initials': 'AP', 'LastName': 'Dhaygude', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035344'] 2264,32571870,Long-term efficacy and safety of canakinumab in patients with colchicine-resistant familial Mediterranean fever: results from the randomised phase III CLUSTER trial.,"OBJECTIVES To evaluate the long-term efficacy and safety of canakinumab to treat patients with colchicine-resistant familial Mediterranean fever (crFMF) during Epoch 4 (weeks 41 to 113) of the CLUSTER study. METHODS Patients received open-label canakinumab 150 or 300 mg, every 4 or 8 weeks during a 72-week period. We evaluated disease activity every 8 weeks using the physician global assessment (PGA) of disease activity, counting the number of flares, and measuring concentrations of C reactive protein (CRP) and serum amyloid A (SAA). Safety was studied by determination and classification of observed adverse events (AEs). We analysed safety and efficacy separately in two subgroups of patients receiving a cumulative dose of less than 2700 mg, or equal or more than 2700 mg. RESULTS Of the 61 patients that started the CLUSTER study, 60 entered Epoch 4 and 57 completed it. During the 72-week period, 35/60 (58.3%) patients experienced no flares, and 23/60 (38.3%) had one flare, as compared with a median of 17.5 flares per year reported at baseline. PGA scores indicated no disease activity for the majority of patients throughout the study. Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold. No new or unexpected AEs were reported. CONCLUSION crFMF patients treated with canakinumab during 72 weeks experienced a minimal incidence of flares and good control of clinical disease activity, with no new safety concerns reported.",2020,"Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold.","['two subgroups of patients receiving a cumulative dose of less than 2700\u2009mg, or equal or more than 2700\u2009mg', 'patients with colchicine-resistant familial Mediterranean fever (crFMF) during Epoch 4 (weeks 41 to 113) of the CLUSTER study', '61 patients that started the CLUSTER study', 'patients with colchicine-resistant familial Mediterranean fever', 'Patients received']","['canakinumab', 'open-label canakinumab']","['physician global assessment (PGA) of disease activity, counting the number of flares, and measuring concentrations of C reactive protein (CRP) and serum amyloid A (SAA', 'disease activity', 'minimal incidence of flares and good control of clinical disease activity', 'Median CRP concentrations', 'median SAA concentrations', 'safety and efficacy', 'PGA scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0459372,"Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold.","[{'ForeName': 'Seza', 'Initials': 'S', 'LastName': 'Ozen', 'Affiliation': 'Department of Pediatric Rheumatology, Hacettepe University, Ankara, Turkey sezaozen@gmail.com.'}, {'ForeName': 'Eldad', 'Initials': 'E', 'LastName': 'Ben-Cherit', 'Affiliation': 'Rheumatology Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Foeldvari', 'Affiliation': 'Pediatric Rheumatology, Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Amarilyo', 'Affiliation': ""Pediatric Rheumatology Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Huri', 'Initials': 'H', 'LastName': 'Ozdogan', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, University of Istanbul-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Vanderschueren', 'Affiliation': 'Clinical Department of General Internal Medicine, Research Department of Immunology, Microbiology and Transplantation, Laboratory for Clinical Infectious and Inflammatory Disorders, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marzan', 'Affiliation': ""Pediatrics Keck School of Medicine of USC, Children's Hospital Los Angeles, Los Angeles, California, USA.""}, {'ForeName': 'J Michelle', 'Initials': 'JM', 'LastName': 'Kahlenberg', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Immunology, Hepatology & Dermatology Franchise, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'De Benedetti', 'Affiliation': 'Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, Roma, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Koné-Paut', 'Affiliation': 'Université de Paris Sud-Saclay, Le Kremlin Bicêtre, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217419'] 2265,32393412,Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study.,"BACKGROUND. Combination olanzapine and samidorphan (OLZ/SAM), in development for schizophrenia and bipolar I disorder, is intended to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. OLZ/SAM safety, tolerability, and efficacy from a 52-week open-label extension study in patients with schizophrenia are reported. METHODS. Patients previously completing the 4-week, double-blind ENLIGHTEN-1 study switched from OLZ/SAM, olanzapine, or placebo to OLZ/SAM. Assessments included adverse events (AEs), weight, vital signs, Positive and Negative Syndrome Scale (PANSS), and Clinical Global Impression-Severity (CGI-S) scores. Baseline was prior to first dose of OLZ/SAM in the extension study. RESULTS. In total, 281 patients enrolled, 277 received ≥1 OLZ/SAM dose, and 183 (66.1%) completed 52 weeks. Reasons for discontinuation included patient withdrawal (15.5%), loss to follow-up (6.9%), AEs (5.8%), and lack of efficacy (1.8%). AEs were reported in 136 (49.1%) patients; increased weight (13%) and somnolence (8%) were most common. Ten serious AEs were reported in eight patients (2.9%); none were considered treatment related. There were no deaths. Mean (SD) baseline weight was 79.1 (17.8) kg. Mean weight change from baseline to week 52 was 1.86 kg (2.79% increase). PANSS total and CGI-S scores continued to decline over 52 weeks (mean [95% CI] changes from baseline to week 52: -16.2 [-18.5, -14.0] and -0.9 [-1.0, -0.8], respectively). CONCLUSION. OLZ/SAM was generally well tolerated in this extension study; most patients completed the 52-week treatment period with sustained improvement in schizophrenia symptoms. Mean increases in weight stabilized by week 6 with limited subsequent change through end of treatment.",2020,PANSS total and CGI-S scores continued to decline over 52 weeks (mean [95% CI] changes from baseline to week 52: -16.2,"['patients with schizophrenia', '281 patients enrolled, 277 received ≥1 OLZ/SAM dose, and 183 (66.1%) completed 52 weeks', 'patients with schizophrenia are reported']","['olanzapine', 'olanzapine and samidorphan (OLZ/SAM', 'olanzapine and samidorphan', 'OLZ/SAM, olanzapine, or placebo to OLZ/SAM', 'OLZ/SAM']","['weight', 'weight stabilized', 'PANSS total and CGI-S scores', 'Mean (SD) baseline weight', 'schizophrenia symptoms', 'somnolence', 'adverse events (AEs), weight, vital signs, Positive and Negative Syndrome Scale (PANSS), and Clinical Global Impression-Severity (CGI-S) scores', 'OLZ/SAM safety, tolerability, and efficacy', 'Mean weight change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",281.0,0.0803671,PANSS total and CGI-S scores continued to decline over 52 weeks (mean [95% CI] changes from baseline to week 52: -16.2,"[{'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Yagoda', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Arevalo', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDonnell', 'Affiliation': 'Alkermes Pharma Ireland Limited, Dublin, Ireland.'}]",CNS spectrums,['10.1017/S1092852920001376'] 2266,32497304,Changes in knee adduction moment wearing a variable-stiffness shoe correlate with changes in pain and mechanically stimulated cartilage oligomeric matrix levels.,"This study aimed to determine if changes in knee adduction moment (KAM) after 6 months of variable-stiffness shoe wear are associated with changes in symptoms or serum levels of cartilage oligomeric matrix protein (COMP) following a mechanical stimulus in subjects with medial knee osteoarthritis (OA). Twenty-five subjects were enrolled in the study and assigned a variable-stiffness shoe, and 19 subjects completed the 6-month follow-up. At baseline and follow-up subjects underwent gait analysis in control and variable-stiffness shoes, completed Western Ontario and McMaster Universities (WOMAC) questionnaires, and serum COMP concentrations were measured immediately before, 3.5 and 5.5 hours after a 30-minute walking activity. Relationships between changes in KAM (first peak and impulse) and changes in (a) COMP levels in response to the 30-minute walking activity and (b) WOMAC scores from baseline to 6-month follow-up were assessed by Pearson correlation coefficients. Changes in first peak KAM were associated with changes in COMP levels 5.5 hours postactivity from baseline to follow-up (R = .564, P = .045). Subjects with greater reductions in KAM had larger decreases in COMP (expressed as a percent of preactivity levels) at follow-up. Subjects with greater reductions in KAM impulse had significantly greater improvements in WOMAC Pain (R = -.56, P = .015) and Function (R = -.52, P = .028) scores at follow-up. The study results demonstrated the magnitude of reduction in the KAM wearing a variable-stiffness shoe is associated with decreases in mechanically stimulated COMP levels and pain/function. This work suggests that interactions between COMP and joint loading during walking should be further investigated in future studies of treatment outcomes in OA.",2020,"Subjects with greater reductions in KAM impulse had significantly greater improvements in WOMAC Pain (R = -.56, P = .015) and Function (R = -.52, P = .028) scores at follow-up.","['Twenty-five subjects were enrolled in the study and assigned a variable-stiffness shoe, and 19 subjects completed the 6-month follow-up', 'subjects with medial knee osteoarthritis (OA']",['KAM'],"['COMP levels', 'COMP', 'knee adduction moment (KAM', 'KAM (first peak and impulse) and changes in (a) COMP levels in response to the 30-minute walking activity and (b) WOMAC scores', 'Western Ontario and McMaster Universities (WOMAC) questionnaires, and serum COMP concentrations', 'WOMAC Pain']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]","[{'cui': 'C0601900', 'cui_str': 'COMP (Cartilage Oligomeric Matrix Protein)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",25.0,0.0232041,"Subjects with greater reductions in KAM impulse had significantly greater improvements in WOMAC Pain (R = -.56, P = .015) and Function (R = -.52, P = .028) scores at follow-up.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Migliore', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Nguyen', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24770'] 2267,31761387,Effective treatment with balneophototherapy and narrowband UVB monotherapy reduces skin homing Th17/Tc17 and Th22/Tc22 effector cells in peripheral blood in patients with psoriasis.,,2019,,['patients with psoriasis'],['balneophototherapy and narrowband UVB monotherapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}]",[],,0.0217974,,"[{'ForeName': 'Jenna Huld', 'Initials': 'JH', 'LastName': 'Eysteinsdóttir', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavík, Iceland. Electronic address: jenna@hudlaeknastodin.is.'}, {'ForeName': 'Hildur', 'Initials': 'H', 'LastName': 'Sigurgrímsdóttir', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavík, Iceland; Department of Immunology, Landspitali - The National University Hospital of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Helga Kristín', 'Initials': 'HK', 'LastName': 'Einarsdóttir', 'Affiliation': 'Department of Immunology, Landspitali - The National University Hospital of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Jona', 'Initials': 'J', 'LastName': 'Freysdottir', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavík, Iceland; Department of Immunology, Landspitali - The National University Hospital of Iceland, Reykjavík, Iceland; Centre for Rheumatology Research, Landspitali - The National University Hospital of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Bjarni A', 'Initials': 'BA', 'LastName': 'Agnarsson', 'Affiliation': 'Department of Pathology, Landspitali - The National University Hospital of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Jón Hjaltalín', 'Initials': 'JH', 'LastName': 'Ólafsson', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Bárður', 'Initials': 'B', 'LastName': 'Sigurgeirsson', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Björn Rúnar', 'Initials': 'BR', 'LastName': 'Lúðvíksson', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavík, Iceland; Department of Immunology, Landspitali - The National University Hospital of Iceland, Reykjavík, Iceland.'}]",Journal of dermatological science,['10.1016/j.jdermsci.2019.10.001'] 2268,31771407,"Interactions between macro-nutrients' intake, FTO and IRX3 gene expression, and FTO genotype in obese and overweight male adolescents.","This study is the first to identify the effects of FTO genotype on the interactions between the level of macro-nutrients intake and the expression level of fat mass and obesity associated (FTO) and homeobox transcription factor iriquois-3 (IRX3) genes This longitudinal study was carried out on 84 overweight and obese adolescent boys in Tehran, Iran. The rs9930506 SNP in FTO was genotyped at baseline and the level of FTO and IRX3 expression in PBMCs and macro-nutrients' intake were assessed at baseline and after 18 weeks of the intervention. The results identified that the higher carbohydrates intake significantly up-regulated the FTO gene (P = 0.001) and down-regulated the IRX3 gene (P = 0.01). Protein intake up-regulated the FTO gene (P = 0.001). In carriers of GG genotype of FTO gene, the amount of dietary carbohydrate had a positive association with FTO gene expression (p = 0.001, and p = 0.04, respectively). In AA/AG carriers, dietary protein was positively associated with FTO gene expression (p = 0.001) and dietary carbohydrate was negatively associated with IRX3 gene expression (P = 0.04). Therefore, dietary carbohydrateseems to be associated with FTO and IRX3 genes expression. These associations are influenced by FTO genotype.",2019,The results identified that the higher carbohydrates intake significantly up-regulated the FTO gene (P = 0.001) and down-regulated the IRX3 gene (P = 0.01).,"['84 overweight and obese adolescent boys in Tehran, Iran', 'obese and overweight male adolescents']",[],"['higher carbohydrates intake', 'dietary carbohydrate', 'IRX3 gene expression', 'FTO gene expression', 'FTO gene']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012170', 'cui_str': 'Carbohydrates, Dietary'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",84.0,0.0248373,The results identified that the higher carbohydrates intake significantly up-regulated the FTO gene (P = 0.001) and down-regulated the IRX3 gene (P = 0.01).,"[{'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Doaei', 'Affiliation': 'Research Center of Health and Environment, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Kalantari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pantea', 'Initials': 'P', 'LastName': 'Izadi', 'Affiliation': 'Department of Medical Genetics, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tuire', 'Initials': 'T', 'LastName': 'Salonurmi', 'Affiliation': 'Department of Internal Medicine, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Alireza Mosavi', 'Initials': 'AM', 'LastName': 'Jarrahi', 'Affiliation': 'Faculty of Medical School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Rafieifar', 'Affiliation': 'Health Promotion and Education Department, Ministry of Health, Tehran, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Azizi Tabesh', 'Affiliation': 'Department of Medical Genetics, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Rahimzadeh', 'Affiliation': 'Institute for Intelligent Systems Research and Innovation (IISRI), Deakin University, Geelong Waurn Ponds, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gholamalizadeh', 'Affiliation': 'Student Research Committee, Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mark O', 'Initials': 'MO', 'LastName': 'Goodarzi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",Adipocyte,['10.1080/21623945.2019.1693745'] 2269,32565335,Assessment of mechanical root canal preparation with centric reciprocating or eccentric rotary kinematics: a micro-computed tomography study.,"INTRODUCTION The aim of this study was to compare, using micro-computed tomography, the preparation of mesial canals of mandibular molars with the Reciproc and XP-endo Shaper systems, evaluating changes in dentin and canal volume, the percentage of untouched walls, the volume of accumulated hard tissue debris and root canal deviation in the apical third. METHODS Twenty-four mandibular molars with two mesial root canals and a single foramen were anatomically paired and divided into two experimental groups (n=12) according to the system used. The specimens were scanned before and after preparation with a SkyScan 1176 microtomograph (Bruker-microCT, Kontich, Belgium) at a resolution of 17.42 μm. The resulting data were statistically compared at a significance level of 5% using Student's t-test and the Mann-Whitney test. RESULTS A significant difference was observed in untouched surface area for the total canal and for the cervical and middle thirds, with the lowest untouched surface area in the XP-endo Shaper group (P <0.05). The volume of accumulated hard tissue debris was significantly higher in the Reciproc group in the total canal as well as in the middle and apical thirds. There was no significant difference between the groups regarding the volume of dentin removed or the increase in canal volume and surface area (P >0.05). CONCLUSION The XP-endo Shaper touched more walls and left less accumulated hard tissue debris in the root canal system than did the Reciproc system.",2020,"There was no significant difference between the groups regarding the volume of dentin removed or the increase in canal volume and surface area (P >0.05). ",['Twenty-four mandibular molars with two mesial root canals and a single foramen'],['mechanical root canal preparation with centric reciprocating or eccentric rotary kinematics'],"['volume of dentin removed or the increase in canal volume and surface area', 'volume of accumulated hard tissue debris']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0447375', 'cui_str': 'Mesial tooth root'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0440266', 'cui_str': 'Debris'}]",,0.0240672,"There was no significant difference between the groups regarding the volume of dentin removed or the increase in canal volume and surface area (P >0.05). ","[{'ForeName': 'P O F', 'Initials': 'POF', 'LastName': 'Fernandes', 'Affiliation': 'DDS, Ms., School of Dentistry, University of São Paulo, SP, Brazil.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Freire', 'Affiliation': 'DDS, Ms., PhD, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Iglecias', 'Affiliation': 'DDS, Ms., PhD, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Vieira', 'Affiliation': 'DDS, Ms., School of Dentistry, Federal University of Paraiba, João Pessoa, Paraíba, PB, Brazil.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Zuolo', 'Affiliation': 'DDS, Ms., PhD, Piracicaba Dental School, State University of Campinas, Piracicaba, SP, Brazil.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gavini', 'Affiliation': 'DDS, Ms., PhD, Professor and Division Head of Endodontics, Restorative Dentistry, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil. Electronic address: ggavini@usp.br.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.005'] 2270,32565344,"Immunogenicity, safety and inter-lot consistency of a meningococcal conjugate vaccine (MenACYW-TT) in adolescents and adults: A Phase III randomized study.","BACKGROUND MenACYW-TT is an investigational quadrivalent (serogroups A, C, W and Y) meningococcal conjugate vaccine that is being developed for protection against invasive meningococcal disease. METHODS In this Phase 3, blinded, randomized study, 3344 meningococcal vaccine-naïve 10-55-year-olds were randomized (3:3:3:2) to receive one of three lots of MenACYW-TT or licensed quadrivalent meningococcal conjugate vaccine, MCV4-DT (NCT02842853). Antibody titers were assessed by human and rabbit complement serum bactericidal antibody assays. The co-primary objectives were to demonstrate lot-to-lot consistency of MenACYW-TT by the between-lot geometric mean titer ratios (GMTR) at Day 30, and non-inferiority of Day 30 vaccine seroresponses (titers ≥ 1:16 if pre-vaccination titers < 1:8, or ≥ 4-fold increase if pre-vaccination titers ≥ 1:8) with MenACYW-TT vs MCV4-DT. Further objectives included safety and immunogenicity. RESULTS Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1. The proportion of participants achieving seroresponse in the MenACYW-TT group (data pooled from the 3 lots) was non-inferior to MCV4-DT (A: 74% vs 55%; C: 89% vs 48%; W: 80% vs 61%; Y: 91% vs 73%, respectively). MenACYW-TT and MCV4-DT had similar safety profiles; no safety concerns were identified. CONCLUSIONS The study met both co-primary endpoints, demonstrating lot-to-lot consistency and non-inferiority of MenACYW-TT vs MCV4-DT in adolescents and adults.",2020,"RESULTS Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1.","['3344 meningococcal vaccine-naïve 10-55-year-olds', 'adolescents and adults']","['meningococcal conjugate vaccine (MenACYW-TT', 'MCV4-DT', 'MenACYW-TT or licensed quadrivalent meningococcal conjugate vaccine, MCV4-DT (NCT02842853']","['Immunogenicity, safety and inter-lot consistency', 'Antibody titers', 'safety and immunogenicity']","[{'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}]",3344.0,0.232694,"RESULTS Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1.","[{'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: MandeepSingh.Dhingra@sanofi.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'J Lewis Research, Salt Lake City, UT 84109, USA. Electronic address: jpeterson@foothillfamilyclinic.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hedrick', 'Affiliation': 'Kentucky Pediatric and Adult Research, Bardstown, KY 40004, USA. Electronic address: jhedrick@bardstowncable.net.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Global Biostatistical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: judy.pan@sanofi.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neveu', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: david.neveu@sanofi.com.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: emilia.jordanov@sanofi.com.'}]",Vaccine,['10.1016/j.vaccine.2020.06.013'] 2271,32565388,A randomised open-label phase III trial evaluating the addition of denosumab to standard first-line treatment in advanced NSCLC - the ETOP and EORTC SPLENDOUR trial.,"INTRODUCTION RANKL stimulates NF-kB-dependent cell-signalling and acts as the primary signal for bone resorption. Retrospective analysis of a large trial comparing denosumab versus zoledronic acid in bone metastatic solid tumours suggested significant overall survival (OS) advantage for lung cancer patients with denosumab. The randomised open-label phase III SPLENDOUR trial was designed to evaluate whether the addition of denosumab to standard first-line platinum-based doublet chemotherapy improves OS in advanced NSCLC. METHODS Stage IV NSCLC patients were randomised 1:1 to either chemotherapy with or without denosumab (120mg every 3-4 weeks), stratified by presence of bone metastases (at diagnosis), ECOG performance status, histology and region. To detect an OS increase from 9-11.25 months (HR=0.80), 847 OS events were required. The trial closed prematurely due to decreasing accrual rate. RESULTS 514 patients were randomised, 509 receiving ≥1 dose of assigned treatment (chemotherapy:252, chemotherapy-denosumab:257). Median age was 66.1 years, 71% male, 59% former smokers. Bone metastases were identified in 275(53%) patients. Median OS(95%CI) was 8.7(7.6-11.0) in the control versus 8.2(7.5-10.4) months in the chemotherapy-denosumab-arm, (HR=0.96;95%CI:[0.78-1.19]; 1-sided P=0.36). For patients with bone metastasis HR=1.02(95%CI:[0.77-1.35]), while for those without HR=0.90(95%CI:[0.66-1.23]). Grade≥3 adverse events were observed in 40.9%/5.2%/8.7% versus 45.5%/10.9%/10.5% of patients. Conditional power for OS benefit was ≤10%. CONCLUSIONS Denosumab was well tolerated without unexpected safety concerns. There was no OS improvement for denosumab when added to chemotherapy in the ITT, and in the subgroups with and without bone metastases. Our data do not provide evidence of a clinical benefit for denosumab in NSCLC patients without bone metastases.",2020,"Median OS(95%CI) was 8.7(7.6-11.0) in the control versus 8.2(7.5-10.4) months in the chemotherapy-denosumab-arm,","['Median age was 66.1 years, 71% male, 59% former smokers', 'lung cancer patients with denosumab', '514 patients', 'NSCLC patients without bone metastases', 'Stage IV NSCLC patients']","['chemotherapy with or without denosumab', '509 receiving ≥1 dose of assigned treatment (chemotherapy:252, chemotherapy-denosumab:257', 'denosumab to standard first-line treatment', 'denosumab versus zoledronic acid', 'denosumab to standard first-line platinum-based doublet chemotherapy', 'Denosumab']","['Median OS(95%CI', 'Bone metastases', 'OS improvement', 'overall survival (OS) advantage', 'Conditional power for OS benefit', 'Grade≥3 adverse events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",514.0,0.243713,"Median OS(95%CI) was 8.7(7.6-11.0) in the control versus 8.2(7.5-10.4) months in the chemotherapy-denosumab-arm,","[{'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland. Electronic address: Solange.Peters@chuv.ch.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': 'Department of Oncology and Metabolism & Sheffield Experimental Cancer Medicine Centre, University of Sheffield, Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Baktiar', 'Initials': 'B', 'LastName': 'Hasan', 'Affiliation': 'Headquarters, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'National and Kapodistrian University of Athens & Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Kliniken GmbH, Asklepios Fachkliniken Muenchen-Gauting, Germany.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Department of Medical Oncology, Hospital De La Santa Creu I Sant Pau, Barcelona, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Kurt G', 'Initials': 'KG', 'LastName': 'Tournoy', 'Affiliation': 'Faculty of Medicine and Life Sciences, Ghent University and Onze-Lieve-Vrouwziekenhuis (OLV), Aalst, Belgium.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Mark', 'Affiliation': 'Department of Medical Oncology, Cantonal Hospital Graubuenden, Chur, Switzerland; Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Pless', 'Affiliation': 'Department of Medical Oncology and Hematology, Cantonal Hospital Winterthur, Winterthur, Switzerland; Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Department of Medical Oncology, Hospital Regional Universitario de Málaga. IBIMA., Málaga, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Universidad de Las Palmas de Gran Canaria, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Las Palmas, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Falchero', 'Affiliation': 'Department of Pneumology and Thoracic Oncology, Hopital Nord-Ouest, Villefranche-sur-Saône Cedex, France.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Moran', 'Affiliation': 'ICO Badalona, Hospital Germans Trias i Pujol, Barcelona, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Ortega Granados', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario de Jaén, Jaén, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Department of Pneumology, Centre Hopitalier Intercommunal De Créteil, Créteil, France.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Mohorcic', 'Affiliation': 'Department of Medical Oncology, University Clinic Golnik, Golnik, Slovenia.'}, {'ForeName': 'Bartomeu Massutí', 'Initials': 'BM', 'LastName': 'Sureda', 'Affiliation': 'ISABIAL, Hospital Universitario Alicante, Alicante, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Betticher', 'Affiliation': 'Department of Medical Oncology, Fribourg Cantonal Hospital (HFR), Fribourg, Switzerland; Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'Ingel', 'Initials': 'I', 'LastName': 'Demedts', 'Affiliation': 'Department of Pulmonary Diseases, AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'Jose Antionio', 'Initials': 'JA', 'LastName': 'Macias', 'Affiliation': 'Department of Hematology and Oncology, Hospital General Universitario Morales Meseguer, Murcia, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Cuffe', 'Affiliation': ""Department of Medical Oncology, St. James's Hospital, Dublin, Ireland; Cancer Trials Ireland.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Luciani', 'Affiliation': 'Department of Medical Oncology, Ospedale San Paolo, Milano, Italy.'}, {'ForeName': 'Jose Garcia', 'Initials': 'JG', 'LastName': 'Sanchez', 'Affiliation': 'Department of Medical Oncology, University Hospital Arnau de Vilanova, Valencia, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Curioni-Fontecedro', 'Affiliation': 'Department for Medical Oncology and Hematology, University Hospital Zürich, Zürich, Switzerland; Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gautschi', 'Affiliation': 'University of Bern, Cantonal Hospital Lucerne, Luzern, Switzerland; Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Price', 'Affiliation': 'Department of Medical Oncology, Aberdeen Royal Infirmary NHS Grampian, Aberdeen, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Coate', 'Affiliation': 'Mid-Western Cancer Centre, University Hospital Limerick, Limerick, Ireland; Cancer Trials Ireland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'von Moos', 'Affiliation': 'Department of Medical Oncology, Cantonal Hospital Graubuenden, Chur, Switzerland; Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zielinski', 'Affiliation': 'Clinical Division of Oncology, Medical University Vienna, Vienna, Austria; Central European Cooperative Oncology Group (CECOG).'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Department of Medical Oncology, Hospital Puerta de Hierro-Majadahonda, Madrid, Spain; Spanish lung cancer group (GECP).'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Menis', 'Affiliation': 'Headquarters, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium; Department of Surgery, Oncology and Gastroenterology, University of Padova, and Medical Oncology Department, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ruepp', 'Affiliation': 'Coordinating Office, European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Pochesci', 'Affiliation': 'Headquarters, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Roschitzki-Voser', 'Affiliation': 'Coordinating Office, European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Gustave Roussy Cancer Center Villejuif, and Paris Saclay University, Orsay, France; Headquarters, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'Coordinating Office, European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'Mary E R', 'Initials': 'MER', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Medical Oncology, Royal Marsden Hospital Sutton, UK.'}, {'ForeName': 'Rolf A', 'Initials': 'RA', 'LastName': 'Stahel', 'Affiliation': 'Department for Medical Oncology and Hematology, University Hospital Zürich, Zürich, Switzerland.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.06.011'] 2272,32565419,Improving quality of care in less than 1 min: a prospective intervention study on postoperative handovers to the ICU/PACU.,"PURPOSE Standardisation of the postoperative handover process via checklists, trainings or procedural changes has shown to be effective in reducing information loss. The clinical friction of implementing these measures has received little attention. We developed and evaluated a visual aid (VA) and >1 min in situ training intervention to improve the quality of postoperative handovers to the intensive care unit (ICU) and postoperative care unit. MATERIALS AND METHODS The VA was constructed and implemented via a brief (<1 min) training of anaesthesiologic staff during the operation. Ease of implementation was measured by amount of information transferred, handover duration and handover structure. 50 handovers were audio recorded before intervention and 50 after intervention. External validity was evaluated by blinded assessment of the recordings by experienced anaesthesiologists (n=10) on 10-point scales. RESULTS The brief intervention resulted in increased information transfer (9.0-14.8 items, t (98)=7.44, p<0.0001, Cohen's d=1.59) and increased handover duration (81.3-192.8 s, t (98)=6.642, p=0.013, Cohen's d=1.33) with no loss in structure (1.60-1.56, t (98)=0.173, p=0.43). Blinded assessment on 10-point scales by experienced anaesthesiologists showed improved overall handover quality from 7.1 to 7.8 ( t (98)=1.89, p=0.031, Cohen's d=0.21) and improved completeness of information ( t (98)=2.42, p=0.009, Cohen's d=0.28) from 7.3 to 8.3. CONCLUSIONS An intervention consisting of a simple VA and <1 min instructions significantly increased overall quality and amount of information transferred during ICU/postanaesthetic care unit handovers.",2020,An intervention consisting of a simple VA and <1 min instructions significantly increased overall quality and amount of information transferred during ICU/postanaesthetic care unit handovers.,[],['ICU/PACU'],"['information transfer', 'completeness of information', 'Improving quality of care', 'overall quality', 'External validity', 'overall handover quality', 'handover duration']",[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",50.0,0.0575622,An intervention consisting of a simple VA and <1 min instructions significantly increased overall quality and amount of information transferred during ICU/postanaesthetic care unit handovers.,"[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Keller', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Campus Virchow Klinikum and Charité Centrum Mitte (CVK/CCM), Charité Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin, Institute of Health, Berlin, Germany niklas.keller@charite.de.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Bosse', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Campus Virchow Klinikum and Charité Centrum Mitte (CVK/CCM), Charité Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin, Institute of Health, Berlin, Germany.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Memmert', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Campus Virchow Klinikum and Charité Centrum Mitte (CVK/CCM), Charité Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin, Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Treskatsch', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin (CBF), Charité Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Campus Virchow Klinikum and Charité Centrum Mitte (CVK/CCM), Charité Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin, Institute of Health, Berlin, Germany.'}]",BMJ open quality,['10.1136/bmjoq-2019-000668'] 2273,32565444,Intravenous iron and chronic obstructive pulmonary disease: a randomised controlled trial.,"BACKGROUND Increased iron availability modifies cardiorespiratory function in healthy volunteers and improves exercise capacity and quality of life in patients with heart failure or pulmonary hypertension. We hypothesised that intravenous iron would produce improvements in oxygenation, exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD). METHODS We performed a randomised, placebo-controlled, double-blind trial in 48 participants with COPD (mean±SD: age 69±8 years, haemoglobin 144.8±13.2 g/L, ferritin 97.1±70.0 µg/L, transferrin saturation 31.3%±15.2%; GOLD grades II-IV), each of whom received a single dose of intravenous ferric carboxymaltose (FCM; 15 mg/kg bodyweight) or saline placebo. The primary endpoint was peripheral oxygen saturation (SpO 2 ) at rest after 1 week. The secondary endpoints included daily SpO 2 , overnight SpO 2 , exercise SpO 2 , 6 min walk distance, symptom and quality of life scores, serum iron indices, spirometry, echocardiographic measures, and exacerbation frequency. RESULTS SpO 2 was unchanged 1 week after FCM administration (difference between groups 0.8%, 95% CI -0.2% to 1.7%). However, in secondary analyses, exercise capacity increased significantly after FCM administration, compared with placebo, with a mean difference in 6 min walk distance of 12.6 m (95% CI 1.6 to 23.5 m). Improvements of ≥40 m were observed in 29.2% of iron-treated and 0% of placebo-treated participants after 1 week (p=0.009). Modified MRC Dyspnoea Scale score was also significantly lower after FCM, and fewer participants reported scores ≥2 in the FCM group, compared with placebo (33.3% vs 66.7%, p=0.02). No significant differences were observed in other secondary endpoints. Adverse event rates were similar between groups, except for hypophosphataemia, which occurred more frequently after FCM (91.7% vs 8.3%, p<0.001). CONCLUSIONS FCM did not improve oxygenation over 8 weeks in patients with COPD. However, this treatment was well tolerated and produced improvements in exercise capacity and functional limitation caused by breathlessness. These effects on secondary endpoints require confirmation in future studies. TRIAL REGISTRATION NUMBER ISRCTN09143837.",2020,"BACKGROUND Increased iron availability modifies cardiorespiratory function in healthy volunteers and improves exercise capacity and quality of life in patients with heart failure or pulmonary hypertension.","['48 participants with COPD (mean±SD', 'healthy volunteers', 'patients with COPD', 'age 69±8 years, haemoglobin 144.8±13.2\u2009g/L, ferritin 97.1±70.0', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with heart failure or pulmonary hypertension', 'and chronic obstructive pulmonary disease']","['Intravenous iron', 'placebo', 'intravenous ferric carboxymaltose (FCM', 'FCM', 'saline placebo']","['daily SpO 2 , overnight SpO 2 , exercise SpO 2 , 6\u2009min walk distance, symptom and quality of life scores, serum iron indices, spirometry, echocardiographic measures, and exacerbation frequency', 'peripheral oxygen saturation (SpO 2 ', 'Modified MRC Dyspnoea Scale score', 'exercise capacity and functional limitation', 'exercise capacity', 'oxygenation, exercise capacity and quality of life', 'Adverse event rates', 'exercise capacity and quality of life']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",48.0,0.763071,"BACKGROUND Increased iron availability modifies cardiorespiratory function in healthy volunteers and improves exercise capacity and quality of life in patients with heart failure or pulmonary hypertension.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Santer', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'McGahey', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Frise', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nayia', 'Initials': 'N', 'LastName': 'Petousi', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Nick P', 'Initials': 'NP', 'LastName': 'Talbot', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Baskerville', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bafadhel', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Annabel H', 'Initials': 'AH', 'LastName': 'Nickol', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Robbins', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK peter.robbins@dpag.ox.ac.uk.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000577'] 2274,32565450,One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial.,"INTRODUCTION People with intellectual disability (ID) are more likely to experience loneliness and have smaller social networks, which increases vulnerability to depression. Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population. This pilot study aims to assess the acceptability and feasibility of carrying out a full RCT of one-to-one befriending by volunteers for people with ID, compared with an active control group. METHODS AND ANALYSIS The trial aims to recruit 40 participants with ID. Participants in the intervention arm will receive weekly visits from a volunteer over 6 months. Community befriending schemes will recruit, train, supervise volunteers and match them to individuals with ID. Both groups will receive a booklet about local activities and have access to usual care. Health and social outcomes will be measured at the end of the intervention and 6 months' follow-up. The following outcomes will be assessed: (1) recruitment and retention of individuals with ID and volunteers in the trial, (2) adverse events related to the intervention, (3) the acceptability of the intervention, (4) whether the intervention is delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis in a full trial. Qualitative data from participants, volunteers, staff and carers will identify barriers and facilitators of a future full trial. ETHICS AND DISSEMINATION The study has been approved by the London City and East Research Ethics Committee (reference 18/LO/2188). The findings will be presented at conferences and published in a peer-reviewed journal and in the National Institute of Health Research journals library. A public engagement seminar will be held at the end of the study aimed at key stakeholders. TRIAL REGISTRATION NUMBER ISRCTN63779614.",2020,"Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population.","['volunteers for people with ID, compared with an active control group', 'People with intellectual disability (ID', 'people with intellectual disability and symptoms of depression', 'supervise volunteers and match them to individuals with ID', '40 participants with ID']",[],"['delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis', 'depressive symptoms', 'Health and social outcomes']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",40.0,0.176178,"Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population.","[{'ForeName': 'Afia', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Psychiatry, University College London, London, UK afia.ali@ucl.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mckenzie', 'Affiliation': 'Research and Development, North East London NHS Foundation Trust Goodmayes Hospital, Ilford, Essex, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hassiotis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit of Social and Community Psychiatry, Barts and the London School of Medicine and Dentistry, University of London, London, UK.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Omar', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Panca', 'Affiliation': 'Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fernandez', 'Affiliation': 'Hackney Volunteer and Befriending Scheme, Outward, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Finning', 'Affiliation': 'Hackney Volunteer and Befriending Scheme, Outward, London, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Roe', 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033989'] 2275,32565458,Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study).,"INTRODUCTION Musculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference. METHODS AND ANALYSIS Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019. ETHICS AND DISSEMINATION This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant. TRIAL REGISTRATION NUMBER NCT03767933, first registered on 07 December 2018.",2020,The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone.,"['Parents/caregivers of children presenting to the ED with acute limb injury', 'children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study', '536 children across six Canadian paediatric EDs']","['non-steroidal or opioid analgesia', 'ibuprofen+oral acetaminophen', 'oral ibuprofen+oral hydromorphone', 'hydromorphone', 'ibuprofen', 'acetaminophen', 'placebo']","['efficacy and safety', 'verbal Numerical Rating Scale pain score ≥5']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0743668', 'cui_str': 'Limb injury'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.346972,The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone.,"[{'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada sali@ualberta.ca.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Rajagopal', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Klassen', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Richer', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Emergency Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Willan', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Drendel', 'Affiliation': 'Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': 'Child Health Evaluation Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Pediatrics, Universite de Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Stang', 'Affiliation': 'Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Sawyer', 'Affiliation': 'Pediatrics and Emergency Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Maala', 'Initials': 'M', 'LastName': 'Bhatt', 'Affiliation': 'Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Hickes', 'Affiliation': ""Parent Partner, Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'Paediatrics and Internal Medicine, Schulich School of Medicine & Dentistry, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035177'] 2276,32565464,Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial.,"INTRODUCTION Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) demonstration projects observe that AGYW uptake and adherence to PrEP during risk periods is suboptimal. Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW. Improving HCW competency and communication to support PrEP delivery to AGYW requires new strategies. METHODS AND ANALYSIS PrEP Implementation for Young Women and Adolescents Program-standardised patient (PrIYA-SP) is a cluster randomised trial of a standardised patient actor (SP) training intervention designed to improve HCW adherence to PrEP guidelines and communication skills. We purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya. At baseline, unannounced SP 'mystery shoppers' present to clinics portraying AGYW in common PrEP scenarios for a cross-sectional assessment of PrEP delivery. Twelve facilities will be randomised to receive a 2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing. Unannounced SPs will repeat the assessment in all 24 sites following the intervention. The primary outcome is quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist by SPs blinded to intervention assignment. An intention-to-treat (ITT) analysis will evaluate whether the intervention resulted in higher scores within intervention compared with control facilities, adjusted for baseline SP scores and accounting for clustering by facility. We hypothesise that the intervention will improve quality of PrEP counselling compared with standard of care. Results from this study will inform guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve service delivery for this high-risk group. ETHICS AND DISSEMINATION The protocol was approved by institutional review boards at Kenyatta National Hospital and University of Washington. An external advisory committee monitors social harms. Results will be disseminated through peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER NCT03875950.",2020,Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW.,"['purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya', 'Young Women and Adolescents Program-standardised patient (PrIYA-SP', 'adolescent girls and young women (AGYW) in Kenya', 'Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition']","['standardised patient actor (SP) training intervention', 'counselling for pre-exposure prophylaxis (PrEP', 'Pre-exposure prophylaxis (PrEP', '2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing']","['quality of PrEP counselling', 'quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0085292', 'cui_str': 'Stiff-man syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",24.0,0.17426,Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Larsen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA annalar@uw.edu.'}, {'ForeName': 'Kate S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Pintye', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Abuna', 'Affiliation': 'Research and Programs, Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Harison', 'Initials': 'H', 'LastName': 'Lagat', 'Affiliation': 'Research and Programs, Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Owens', 'Affiliation': 'Health Sciences Simulation & Clinical Skills Center, Howard University, Seattle, Washington, DC, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2019-035689'] 2277,32565477,Is virtual reality effective to teach prevention of surgical site infections in the operating room? study protocol for a randomised controlled multicentre trial entitled VIP Room study.,"INTRODUCTION Some surgical site infections (SSI) could be prevented by following adequate infection prevention and control (IPC) measures. Poor compliance with IPC measures often occurs due to knowledge gaps and insufficient education of healthcare professionals. The education and training of SSI preventive measures does not usually take place in the operating room (OR), due to safety, and organisational and logistic issues. The proposed study aims to compare virtual reality (VR) as a tool for medical students to learn the SSI prevention measures and adequate behaviours (eg, limit movements…) in the OR, to conventional teaching. METHODS AND ANALYSIS This protocol describes a randomised controlled multicentre trial comparing an educational intervention based on VR simulation to routine education. This multicentre study will be performed in three universities: Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany). Third-year medical students of each university will be randomised in two groups. The students randomised in the intervention group will follow VR teaching. The students randomised in the control group will follow a conventional education programme. Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups. The written exam will be the same in the three countries. Secondary outcomes will be satisfaction and students' progression for the VR group. The data will be analysed with intention-to-treat and per protocol. ETHICS AND DISSEMINATION This study has been approved by the Medical Education Ethics Committee of the London Imperial College (MEEC1920-172), by the Ethical Committee for the Research of Grenoble Alpes University (CER Grenoble Alpes-Avis-2019-099-24-2) and by the Ethics Committee of the Medical Faculty of Heidelberg University (S-765/2019). Results will be published in peer-reviewed medical journals, communicated to participants, general public and all relevant stakeholders.",2020,Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups.,"['Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany', 'medical students', 'three universities', 'Third-year medical students of each university']","['conventional education programme', 'educational intervention based on VR simulation to routine education', 'virtual reality (VR']","[""satisfaction and students' progression""]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0677448,Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups.,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Masson', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Birgand', 'Affiliation': 'Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College, London, Greater London, United Kingdom.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Castro-Sánchez', 'Affiliation': 'Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College, London, Greater London, United Kingdom.'}, {'ForeName': 'Vanessa Maria', 'Initials': 'VM', 'LastName': 'Eichel', 'Affiliation': 'Section for Hospital Hygiene and Environmental Health, Centre of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Comte', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Terrisse', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Rubens-Duval', 'Affiliation': 'Department of Orthopaedic Surgery and Sport Traumatology, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gillois', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Albaladejo', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Picard', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Nico Tom', 'Initials': 'NT', 'LastName': 'Mutters', 'Affiliation': 'Section for Hospital Hygiene and Environmental Health, Centre of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Landelle', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France caroline.landelle@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-037299'] 2278,32565480,Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial.,"INTRODUCTION Chronic subdural haematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimise the risk of symptomatic recurrences. In the past, reoperation rates as high as 20%-30% were described for CSDH recurrences. However, following the introduction of subdural drainage, reoperation rates dropped to approximately 10%. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural drainage. Yet, the role of intraoperative irrigation has not been established. If there is no difference in recurrence rates between intraoperative irrigation and no irrigation, CSDH surgery could be carried out faster and more safely by omitting the step of irrigation. The aim of this multicentre randomised controlled trial is to study whether no intraoperative irrigation and subdural drainage results in non-inferior outcome compared with intraoperative irrigation and subdural drainage following burr-hole craniostomy of CSDH. METHODS AND ANALYSIS This is a prospective, randomised, controlled, parallel group, non-inferiority multicentre trial comparing single burr-hole evacuation of CSDH with intraoperative irrigation and evacuation of CSDH without irrigation. In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6 months. The predefined non-inferiority margin for the primary outcome is 7.5%. To achieve a 2.5% level of significance and 80% power, we will randomise 270 patients per group. Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH. ETHICS AND DISSEMINATION The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District (HUS/3035/2019 §238) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER NCT04203550.",2020,"Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH. ",['after evacuation of chronic subdural haematoma (FINISH'],"['CSDH with intraoperative irrigation and evacuation of CSDH without irrigation', 'intraoperative irrigation versus drain alone', 'intraoperative irrigation and subdural drainage']","['modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH', 'reoperation rates', 'recurrence rates', 'symptomatic CSDH recurrence requiring reoperation']","[{'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C1706059', 'cui_str': 'Finish'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",,0.264025,"Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH. ","[{'ForeName': 'Pihla', 'Initials': 'P', 'LastName': 'Tommiska', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland rahul.raj@helsinki.fi.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Kivisaari', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Luostarinen', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Satopää', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Clinical Sciences, Lunds Universitet, Lund, Sweden.'}, {'ForeName': 'Janek', 'Initials': 'J', 'LastName': 'Frantzen', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Posti', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Teemu M', 'Initials': 'TM', 'LastName': 'Luoto', 'Affiliation': 'Department of Neurosurgery, Tampere University Hospital and Tampere University, Tampere, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Leinonen', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Tetri', 'Affiliation': 'Unit of Clinical Neuroscience, Neurosurgery, University of Oulu and Medical Research Center, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Koivisto', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Lönnrot', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}]",BMJ open,['10.1136/bmjopen-2020-038275'] 2279,32565482,Health impacts of seated arm ergometry training in patients with a diabetic foot ulcer: protocol for a randomised controlled trial.,"INTRODUCTION Once diagnosed with a diabetic foot ulcer (DFU), patients are advised to offload, keeping pressure off the foot in order to facilitate ulcer healing. An increase in offloading is often accompanied by reductions in physical activity which can worsen the overall health of patients.While unable to perform traditional forms of upright activity, one mode of exercise that would allow patients to be physically active while adhering to offloading instruction is seated arm ergometry. The merits of tailored aerobic exercise in DFU remain unexplored. METHODS AND ANALYSIS This is a prospective open-label randomised controlled trial. Participants will be randomised to one of two groups, an exercise intervention group or control. The intervention group are required to undertake arm ergometry training at a moderate intensity (65%-75% HRpeak), three times per week for 12 weeks as individually prescribed by an exercise physiologist, while the control group will continue to receive standard care alone. Assessment of outcome measures will occur at baseline and after the intervention period, these will include: a seated VO 2 peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires. The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively. Ulcer area will also be measured as an approximate marker of ulcer healing. ETHICS AND DISSEMINATION This trial has been approved by 'Yorkshire & The Humber-Leeds West Research Ethics Committee' (19/YH/0269). Trial results will be published in peer-reviewed journals and through conference presentations. TRIAL REGISTRATION NUMBER ISRCTN16000053. Registered in accordance with WHO Trial Registration Data Set (version 1.3.1).",2020,"The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively.",['patients with a diabetic foot ulcer'],"['seated arm ergometry training', 'exercise intervention group or control', 'undertake arm ergometry training', 'standard care alone', 'tailored aerobic exercise']","['cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life', 'seated VO 2 peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.117669,"The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK mm636@le.ac.uk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Game', 'Affiliation': 'Department of Diabetes and Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039062'] 2280,32565534,Use of Various Doses of S-Ketamine in Treatment of Depression and Pain in Cervical Carcinoma Patients with Mild/Moderate Depression After Laparoscopic Total Hysterectomy.,"BACKGROUND This study investigated the effects of various doses of S-ketamine on depression and pain management of cervical carcinoma patients with mild/moderate depression. MATERIAL AND METHODS This randomized, double-blind, controlled study included 417 cervical carcinoma patients who received laparoscopic modified radical hysterectomy from April 2015 to July 2018 and who also had mild/moderate depression symptoms based on HAMD-17 scores (8~24). All patients were randomized into 4 groups: 1) the control group, 2) the racemic ketamine group, 3) the high-dose S-ketamine group; and 4) the low-dose S-ketamine group. Pain was assessed using the Visual Analogue Score (VAS), and depression was assessed using theHAMD-17 score. Serum levels of BDNF and 5-HT were measured. RESULTS The 4 groups of patients showed no significant differences in operation time, bleeding volume, hospitalization duration, or complications. The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group. The high-dose S-ketamine group showed significantly higher serum BDNF and 5-HT levels at 1 day and 3 days after surgery. However, 1 week after surgery, no difference was observed in any of the treatment groups. CONCLUSIONS At subanesthetic dose, both 0.5 mg/kg and 0.25 mg/kg S-ketamine improved short-term depression and pain for cervical carcinoma patients after surgery, and the effects were better than with the same dose of racemic ketamine.",2020,"The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group.","['cervical carcinoma patients after surgery', 'cervical carcinoma patients with mild/moderate depression', 'from April 2015 to July 2018 and who also had mild/moderate depression symptoms based on HAMD-17 scores (8~24', 'Cervical Carcinoma Patients with Mild/Moderate Depression', '417 cervical carcinoma patients who received']","['racemic ketamine group, 3) the high-dose S-ketamine group; and 4) the low-dose S-ketamine', 'racemic ketamine', 'ketamine', 'laparoscopic modified radical hysterectomy', 'S-ketamine', 'S-Ketamine']","['short-term depression and pain', 'serum BDNF and 5-HT levels', 'Pain', 'Depression and Pain', 'Visual Analogue Score (VAS), and depression', 'Serum levels of BDNF and 5-HT', 'VAS and HAMD-17 scores', 'depression and pain management', 'operation time, bleeding volume, hospitalization duration, or complications']","[{'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C5191297', 'cui_str': '417'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0559248', 'cui_str': 'Modified radical'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",417.0,0.0808004,"The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Ninth People's Hospital of Suzhou, Suzhou, Jiangsu, China (mainland).""}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Xishan People's Hospital, Wuxi, Jiangsu, China (mainland).""}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (TCM), Shanghai, China (mainland).""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Shanghai Gongli Hospital, Second Military Medical University, Shanghai, China (mainland).'}, {'ForeName': 'Peirong', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (TCM), Shanghai, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922028'] 2281,32565792,"Selenium Supplementation, Body Mass Composition, and Leptin Levels in Patients with Obesity on a Balanced Mildly Hypocaloric Diet: A Pilot Study.","Background Adequate levels of selenium (Se) have protective effects against several chronic diseases, such as obesity. The aim of this study was to assess the effect of Se supplementation in a selected group of patients with obesity. Methods This randomized prospective study included 37 overweight/obese individuals aged 18-65 years, who adopted a slightly hypocaloric diet for 3 months. An intervention group received 240  μ g/day of L-selenomethionine for 3 months; a control group received a placebo. Clinical and biochemical parameters, body composition measurements, and the Psychological General Well-Being Index (PGWBI) questionnaire were tested at the beginning and end of the treatment. Results A comparison of the two groups showed a significant change in body composition, involving a decrease in body fat mass, between the baseline and the end of the follow-up, in the intervention group. Unlike the placebo group, the group given Se had a significant increase in lean body and muscle mass and a significant decrease in leptin levels after 3 months on diet. At the end of the follow-up, the group given Se scored higher on the PGWBI than those who did not. Conclusion Se could reinforce the effects of diet for overweight and obesity. This work was registered in the ISRCTN registry with study ID ISRCTN6106073.",2020,"Unlike the placebo group, the group given Se had a significant increase in lean body and muscle mass and a significant decrease in leptin levels after 3 months on diet.","['Patients with Obesity on a Balanced Mildly Hypocaloric Diet', 'patients with obesity', '37 overweight/obese individuals aged 18-65 years, who adopted a slightly hypocaloric diet for 3 months']","['selenium (Se', 'Se supplementation', '240\u2009 μ g/day of L-selenomethionine', 'placebo']","['body composition', 'Selenium Supplementation, Body Mass Composition, and Leptin Levels', 'Clinical and biochemical parameters, body composition measurements, and the Psychological General Well-Being Index (PGWBI) questionnaire', 'leptin levels', 'lean body and muscle mass', 'body fat mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0036584', 'cui_str': 'Selenomethionine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",37.0,0.0497891,"Unlike the placebo group, the group given Se had a significant increase in lean body and muscle mass and a significant decrease in leptin levels after 3 months on diet.","[{'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Cavedon', 'Affiliation': 'Familial Cancer Clinic and Oncoendocrinology, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Manso', 'Affiliation': 'Endocrinology Unit, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Negro', 'Affiliation': 'Internal Medicine, Alto Vicentino Hospital, Santorso (VI), Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Censi', 'Affiliation': 'Endocrinology Unit, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Serra', 'Affiliation': 'Internal Medicine 3, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Busetto', 'Affiliation': 'Internal Medicine 3, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Vettor', 'Affiliation': 'Internal Medicine 3, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Plebani', 'Affiliation': 'Department of Laboratory Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Pezzani', 'Affiliation': 'Endocrinology Unit, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Nacamulli', 'Affiliation': 'Endocrinology Unit, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Mian', 'Affiliation': 'Endocrinology Unit, Department of Medicine, University of Padua, Padua, Italy.'}]",International journal of endocrinology,['10.1155/2020/4802739'] 2282,32565807,A Novel Nomogram including AJCC Stages Could Better Predict Survival for NSCLC Patients Who Underwent Surgery: A Large Population-Based Study.,"Objective In this study, we aimed to establish a novel nomogram model which was better than the current American Joint Committee on Cancer (AJCC) stage to predict survival for non-small-cell lung cancer (NSCLC) patients who underwent surgery. Patients and Methods . 19617 patients with initially diagnosed NSCLC were screened from Surveillance Epidemiology and End Results (SEER) database between 2010 and 2015. These patients were randomly divided into two groups including the training cohort and the validation cohort. The Cox proportional hazard model was used to analyze the influence of different variables on overall survival (OS). Then, using R software version 3.4.3, we constructed a nomogram and a risk classification system combined with some clinical parameters. We visualized the regression equation by nomogram after obtaining the regression coefficient in multivariate analysis. The concordance index (C-index) and calibration curve were used to perform the validation of nomogram. Receiver operating characteristic (ROC) curves were used to evaluate the clinical utility of the nomogram. Results Univariate and multivariate analyses demonstrated that seven factors including age, sex, stage, histology, surgery, and positive lymph nodes (all, P < 0.001) were independent predictors of OS. Among them, stage (C-index = 0.615), positive lymph nodes (C-index = 0.574), histology (C-index = 0.566), age (C-index = 0.563), and sex (C-index = 0.562) had a relatively strong ability to predict the OS. Based on these factors, we established and validated the predictive model by nomogram. The calibration curves showed good consistency between the actual OS and predicted OS. And the decision curves showed great clinical usefulness of the nomogram. Then, we built a risk classification system and divided NSCLC patients into two groups including high-risk group and low-risk group. The Kaplan-Meier curves revealed that OS in the two groups was accurately differentiated in the training cohort ( P < 0.001). And then, we validated this result in the validation cohort which also showed that patients in the high-risk group had worse survival than those in the low-risk group. Conclusion The results proved that the nomogram model had better performance to predict survival for NSCLC patients who underwent surgery than AJCC stage. These tools may be helpful for clinicians to evaluate prognostic indicators of patients undergoing operation.",2020,The Kaplan-Meier curves revealed that OS in the two groups was accurately differentiated in the training cohort ( P < 0.001).,"['divided NSCLC patients into two groups including high-risk group and low-risk group', 'non-small-cell lung cancer (NSCLC) patients who underwent surgery', '19617 patients with initially diagnosed NSCLC were screened from Surveillance Epidemiology and End Results (SEER) database between 2010 and 2015', 'NSCLC Patients', 'patients undergoing operation']",['Surgery'],"['worse survival', 'overall survival (OS', 'concordance index (C-index) and calibration curve', 'positive lymph nodes']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]",19617.0,0.0397439,The Kaplan-Meier curves revealed that OS in the two groups was accurately differentiated in the training cohort ( P < 0.001).,"[{'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': 'Department of Clinical Laboratory, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Haining', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Personnel Division, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.'}, {'ForeName': 'Jiamao', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine-Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.'}, {'ForeName': 'Zhenxiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Pathology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine-Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.'}]",Journal of oncology,['10.1155/2020/7863984'] 2283,32563253,"Comparison of the effect of rapeseed oil or amaranth seed oil supplementation on weight loss, body composition, and changes in the metabolic profile of obese patients following 3-week body mass reduction program: a randomized clinical trial.","BACKGROUND Amaranth seed oil (ASO) and rapeseed oil (RSO) are functional foods that display antioxidant and hepatoprotective properties. These oils are also known to lower glucose and cholesterol levels. The current study compared the effects exerted by RSO and ASO on weight loss and metabolic parameters during a 3-week body mass reduction program. METHODS Eighty-one obese subjects (BMI > 30 kg/m 2 ), aged 25-70 years, were enrolled in a 3-week body mass reduction program based on a calorie-restricted diet and physical activity. Participants were randomly categorized into an AO group (administered 20 mL/d of ASO), a RO group (administered 20 mL/d of RSO), and a C group (control; untreated). Anthropometric and metabolic parameters were measured at baseline and endpoint. RESULTS Significant decreases in weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), fat mass (FM), lean body mass (LBM), visceral fat mass (VFM), and total body water (TBW%) were observed in all groups (P <  0.05). No significant improvements were observed in the clinical parameters of group C. Fasting insulin (Δ - 5.9, and Δ - 5.7) and homeostatic model assessment of insulin resistance (HOMA-IR) (Δ - 1.1 and Δ - 0.5) were decreased in both RO and AO groups, respectively. Fasting glucose (Δ -8.5; P = 0.034), total cholesterol (Δ -14.6; P = 0.032), non-HDL cholesterol (Δ 15.9; P = 0.010), TG/HDL ratio (Δ -0.6; P = 0.032), LDL cholesterol (Δ -12.3; P = 0.042), and triglycerides (Δ -6.5; P = 0.000) were significantly improved in the AO group, compared to the RO group. CONCLUSIONS The 3-week body mass reduction intervention caused a significant reduction in the weight, BMI, WC, HC, FM, and VFM of all groups. Except for HOMA-IR, there were no statistical differences between the clinical parameters of all groups. However, a trend toward improved insulin levels and HDL% was noticeable in AO and RO. Therapies involving edible oils with high nutritional value, such as RSO and ASO, show potential for improving metabolic measurements during body mass reduction programs. Thus, obese patients undertaking weight reduction programs may benefit from RSO and ASO supplementation. TRIAL REGISTRATION retrospectively registered, DRKS00017708.",2020,"The 3-week body mass reduction intervention caused a significant reduction in the weight, BMI, WC, HC, FM, and VFM of all groups.","['obese patients following 3-week body mass reduction program', 'Eighty-one obese subjects (BMI\u2009>\u200930\u2009kg/m 2 ), aged 25-70\u2009years']","['rapeseed oil or amaranth seed oil supplementation', 'Amaranth seed oil (ASO) and rapeseed oil (RSO', '3-week body mass reduction program based on a calorie-restricted diet and physical activity', 'RSO and ASO']","['weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), fat mass (FM), lean body mass (LBM), visceral fat mass (VFM), and total body water (TBW', 'triglycerides', 'weight loss and metabolic parameters', 'total cholesterol', 'non-HDL cholesterol', 'weight, BMI, WC, HC, FM, and VFM of all groups', 'weight loss, body composition', 'LDL cholesterol', 'insulin levels and HDL', 'Anthropometric and metabolic parameters', 'clinical parameters of group C. Fasting insulin', 'Fasting glucose', 'TG/HDL ratio', 'homeostatic model assessment of insulin resistance (HOMA-IR', 'glucose and cholesterol levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0072982', 'cui_str': 'Brassica Napus Oil'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",81.0,0.0191864,"The 3-week body mass reduction intervention caused a significant reduction in the weight, BMI, WC, HC, FM, and VFM of all groups.","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Moszak', 'Affiliation': 'Department of Obesity and Metabolic Disorders Treatment and Clinical Dietetics, Karol Marcinkowski University of Medical Sciences, ul. Szamarzewskiego 82/84, 60-569, Poznań, Polska, Poland. mmoszak@ump.edu.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Zawada', 'Affiliation': 'Department of Gastroenterology, Dietetics and Internal Medicine, Karol Marcinkowski University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Aldona', 'Initials': 'A', 'LastName': 'Juchacz', 'Affiliation': 'Centre of Pulmonology and Thoracic Surgery, Poznan, Poland.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Grzymisławski', 'Affiliation': 'Department of Gastroenterology, Dietetics and Internal Medicine, Karol Marcinkowski University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Bogdański', 'Affiliation': 'Department of Obesity and Metabolic Disorders Treatment and Clinical Dietetics, Karol Marcinkowski University of Medical Sciences, ul. Szamarzewskiego 82/84, 60-569, Poznań, Polska, Poland.'}]",Lipids in health and disease,['10.1186/s12944-020-01330-7'] 2284,32563259,Radiotherapy combined with gefitinib for patients with locally advanced non-small cell lung cancer who are unfit for surgery or concurrent chemoradiotherapy: a phase II clinical trial.,"BACKGROUND The objectives of this study were to determine the objective effective response rate, survival, and safety of radiotherapy combined with gefitinib in patients with locally advanced non-small cell lung cancer (NSCLC) who were unfit for surgery or concurrent chemoradiotherapy. METHODS The patients with the locally advanced NSCLC who were unfit to receive surgery or concurrent chemoradiotherapy, received thoracic intensity-modulated radiotherapy (IMRT) combined with gefitinib 250 mg daily. RESULTS 29 patients were enrolled between July 2014 and March 2017. 28 patients was in the analysis. Of the 28 patients, 21 (75.0%) experienced a partial response, 5 (17.9%) had stable disease, and 2 (7.1%) experienced progression of disease. The objective response rate was 75.0%, and the disease control rate was 92.9%. The median follow-up time was 51 months. The disease progression showed in 25 (89.3%) patients, including local progression in 19 (67.9%) and distant metastasis in 16 (57.1%). The median overall survival and progression-free survival time (PFS) were 26 and 11 months, respectively. The 3-, 4-, 5-year survival rates were 39.0, 30.1 and 30.1%, respectively. The 3-, 4-, 5-year PFS rates were 14.3, 9.5 and 9.5%. Two patients developed grade 3 acute adverse events. Seven patients developed grade 2 acute irradiation pneumonitis, and there was no grade 3 acute irradiation pneumonitis. CONCLUSIONS For patients with locally advanced NSCLC who are not eligible for surgery or concurrent chemoradiotherapy, IMRT combined with gefitinib can improve the objective effective rate and is generally well-tolerated.",2020,"Seven patients developed grade 2 acute irradiation pneumonitis, and there was no grade 3 acute irradiation pneumonitis. ","['29 patients were enrolled between July 2014 and March 2017', 'patients with locally advanced non-small cell lung cancer (NSCLC) who were unfit for surgery or concurrent chemoradiotherapy', 'patients with locally advanced NSCLC who are not eligible for surgery or concurrent chemoradiotherapy, IMRT combined with', '28 patients was in the analysis', 'patients with the locally advanced NSCLC who were unfit to receive', 'patients with locally advanced non-small cell lung cancer who are unfit for surgery or concurrent']","['radiotherapy combined with gefitinib', 'surgery or concurrent chemoradiotherapy, received thoracic intensity-modulated radiotherapy (IMRT) combined with gefitinib 250\u2009mg daily', 'chemoradiotherapy', 'gefitinib', 'Radiotherapy combined with gefitinib']","['distant metastasis', '5-year PFS rates', 'objective effective rate', 'disease control rate', 'grade 3 acute adverse events', 'progression of disease', 'disease progression', 'median overall survival and progression-free survival time (PFS', 'grade 2 acute irradiation pneumonitis', 'local progression', 'objective effective response rate, survival, and safety', 'partial response', 'objective response rate', '5-year survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",29.0,0.297634,"Seven patients developed grade 2 acute irradiation pneumonitis, and there was no grade 3 acute irradiation pneumonitis. ","[{'ForeName': 'Zhixue', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bi', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Xiaozhen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Luhua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 10021, China. liang23400@163.com.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01596-2'] 2285,30741684,"Pharmacokinetics and Pharmacodynamics of LY2599666, a PEG-Linked Antigen Binding Fragment that Targets Soluble Monomer Amyloid-β.","LY2599666 is a humanized, affinity-optimized monoclonal antibody antigen-binding fragment linked to a PEG molecule and targets soluble amyloid-β (Aβ) monomers. This first-in-human dose ascending study assessed pharmacokinetics (PK) (measured as serum free LY2599666 concentration) and pharmacodynamic (PD) effects (measured as plasma total soluble Aβ40 and Aβ42) after a single subcutaneous (SC) dose of 10, 25, 100, and 200 mg LY2599666 in healthy subjects. As LY2599666 binds to multiple soluble Aβ monomers, a two-target mediated drug disposition model (TMDD) was developed to simultaneously fit serum LY2599666 concentration and Aβ monomer levels. Four Alzheimer's disease patients completed 25 mg once-weekly dosing of LY2599666 for 12 weeks. In addition, single cerebrospinal fluid samples were collected to assess penetration capability across the blood-brain barrier. PK and PD data collected from the multiple dose cohort aligned with model predictions, suggesting the established TMDD model predicted suppression of soluble Aβ40 and Aβ42 in plasma after SC dosing of LY2599666.",2019,"PK and PD data collected from the multiple dose cohort aligned with model predictions, suggesting the established TMDD model predicted suppression of soluble Aβ40 and Aβ42 in plasma after SC dosing of LY2599666.",['healthy subjects'],['LY2599666'],['pharmacokinetics (PK) (measured as serum free LY2599666 concentration) and pharmacodynamic (PD) effects'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0396505,"PK and PD data collected from the multiple dose cohort aligned with model predictions, suggesting the established TMDD model predicted suppression of soluble Aβ40 and Aβ42 in plasma after SC dosing of LY2599666.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eugene Y', 'Initials': 'EY', 'LastName': 'Zhen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rodney L', 'Initials': 'RL', 'LastName': 'Decker', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Willis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waters', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Hake', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ronald Bradley', 'Initials': 'RB', 'LastName': 'Demattos', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mosun', 'Initials': 'M', 'LastName': 'Ayan-Oshodi', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180925'] 2286,31124619,Veno-venous extracorporeal membrane oxygenation in acute respiratory distress syndrome: should the EOLIA Study results change our clinical approach?,"The original discouraging results of extracorporeal membrane oxygenation (ECMO) application in acute respiratory failure caused the technique to be almost abandoned. Fortunately, ECMO survived thanks to the good results obtained in neonates. The interest on ECMO renewed after the publication of the CESAR Trial in 2009. The ultimate rebirth of the technique, however, was due to its use as a rescue therapy in severely hypoxemic patients untreatable with conventional methods during H1N1 flu epidemics in Australia and New Zealand. In 2018 the group of investigators led by Alain Combes designed and implemented the EOLIA Study to test the efficacy of veno-venous ECMO in patients with severe acute respiratory distress syndrome (ARDS). This article discusses the primary and secondary results of the trial and the considerations emerged in the medical community. We will also discuss how ECMO could evolve to maximize lung protection rather than just prevent hypoxic death.",2019,The original discouraging results of extracorporeal membrane oxygenation (ECMO) application in acute respiratory failure caused the technique to be almost abandoned.,"['acute respiratory distress syndrome', 'severely hypoxemic patients untreatable with conventional methods during H1N1 flu epidemics in Australia and New Zealand', 'patients with severe acute respiratory distress syndrome (ARDS']","['veno-venous ECMO', 'Veno-venous extracorporeal membrane oxygenation', 'extracorporeal membrane oxygenation (ECMO) application']",[],"[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2076600', 'cui_str': 'Influenza due to Influenza A virus subtype H1N1'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0391895', 'cui_str': 'Venovenous'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],,0.0241726,The original discouraging results of extracorporeal membrane oxygenation (ECMO) application in acute respiratory failure caused the technique to be almost abandoned.,"[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Ca' Granda Maggiore Polyclinic Hospital I.R.C.C.S. Foundation, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Ca' Granda Maggiore Polyclinic Hospital I.R.C.C.S. Foundation, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Ca' Granda Maggiore Polyclinic Hospital I.R.C.C.S. Foundation, Milan, Italy - antonio.pesenti@unimi.it.""}]",Minerva anestesiologica,['10.23736/S0375-9393.19.13490-6'] 2287,31181395,Distinguishing between demographic and contextual factors linked to early childhood physical discipline and physical maltreatment among Black families.,"BACKGROUND Despite persistent discouragement from professionals, U.S. parents, especially Black parents, highly endorse physical discipline, which also is a risk factor for physical maltreatment. Few studies have examined physical discipline heterogeneity or maltreatment, and predictive demographic and contextual factors within the same population. OBJECTIVE This exploratory study aimed to identify subgroups of Black parents' use of early childhood physical discipline. It also examined whether demographic and contextual factors' relations with physical discipline were similar or different from those with physical maltreatment. PARTICIPANTS AND SETTING 310 Black parents from three geographically-distinct high-risk U.S. communities participated in home-based interview and survey data collection. METHODS We conducted latent class analyses to identify sub-groups among Black parents characterized by physical discipline frequency and type. Bolck, Croon, and Hagenaars method and binary logistic regression were conducted to examine relations between demographic and contextual factors (child gender, family income, marital status, parental education, family stress and perceived neighborhood safety), discipline and maltreatment. RESULTS Three physical discipline classes, which differed in frequency and type, were identified among Black parents. Only income was significantly related to both discipline (x 2  = 18.97, p < .001) and maltreatment (OR = 1.03, p < .01). Child gender (x 2  = 6.66, p < .01), never-married status (x 2  = 13.94, p < .001), parental education (x 2  = 10.32, p < .001), and neighborhood safety (x 2  = 7.57, p < .01) also significantly related to discipline. Family stress was significantly related to physical maltreatment (OR = 1.42, p < .001). CONCLUSIONS Differing demographic and contextual factor relations with physical discipline and maltreatment within a Black population should be considered when identifying parents at-risk.",2019,"Family stress was significantly related to physical maltreatment (OR = 1.42, p < .001). ","['Black families', ""subgroups of Black parents' use of early childhood physical discipline"", '310 Black parents from three geographically-distinct high-risk U.S. communities participated in home-based interview and survey data collection', 'Black parents characterized by physical discipline frequency and type']",[],"['Family stress', 'neighborhood safety', 'parental education', 'demographic and contextual factors (child gender, family income, marital status, parental education, family stress and perceived neighborhood safety), discipline and maltreatment']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0577730', 'cui_str': 'Family tension'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",310.0,0.0129974,"Family stress was significantly related to physical maltreatment (OR = 1.42, p < .001). ","[{'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Scott', 'Affiliation': 'School of Social Work, Boston University, 264 Bay State Road, Boston, MA, 02215, United States. Electronic address: jcscott@bu.edu.'}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Pinderhughes', 'Affiliation': 'Eliot-Pearson Department of Child Study and Human Development, Tufts University, 105 College Avenue, Medford, MA, 02155, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2019.05.013'] 2288,31201109,Effect of foam and liquid bleomycin in the management of venous malformations in head and neck region: A comparative study.,"BACKGROUND Many treatment options for venous malformations (VMs) have been documented in the literature, but injection sclerotherapy has been considered a current mainstay for their treatment. We conducted this study to determine the efficacy and durability of injection of different forms of bleomycin sclerotherapy in the treatment of VMs in the cervico-facial region. PATIENTS AND METHODS Thirty patients with clinically diagnosed VMs of the head and neck region, confirmed by magnetic resonance imaging, had been injected with the bleomycin sclerosing material. They were divided into 2 groups according to the form of bleomycin injected: in Group A, the foam form was injected, and in Group B, the liquid form was injected. Data of patients' demographics, anatomical sites, type and volume of the VMs, number of injection sessions and the average dose of injected agents were documented and statistically compared between the 2 groups. RESULTS MRI showed a decline of more than 90% from the initial size of the lesions in 66.7% of the cases and considerable decline (60-90%) in 33.3% of the cases. In Group A, the number of sessions and the amount of sclerosant material injected were lower than those in Group B. The cumulative dose in the equal-sized lesions was lower in the foam form than in the liquid form. CONCLUSION We recommend using bleomycin in its foam form on a greater number of patients with larger VMs and in different sites, as the results are more promising in this form than in the liquid form.",2020,"RESULTS MRI showed a decline of more than 90% from the initial size of the lesions in 66.7% of the cases and considerable decline (60-90%) in 33.3% of the cases.","['VMs in the cervico-facial region', 'venous malformations in head and neck region', 'Thirty patients with clinically diagnosed VMs of the head and neck region, confirmed by magnetic resonance imaging, had been injected with the bleomycin sclerosing material']","['bleomycin', 'foam and liquid bleomycin', 'bleomycin sclerotherapy']",[],"[{'cui': 'C0265950', 'cui_str': 'Venous malformation'}, {'cui': 'C0205064', 'cui_str': 'Cervical'}, {'cui': 'C0934422', 'cui_str': 'Region of face'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}]",[],30.0,0.0157962,"RESULTS MRI showed a decline of more than 90% from the initial size of the lesions in 66.7% of the cases and considerable decline (60-90%) in 33.3% of the cases.","[{'ForeName': 'Hesham A', 'Initials': 'HA', 'LastName': 'Helal', 'Affiliation': 'Plastic and Reconstructive Surgery Department, Faculty of Medicine, Ain-Shams University, 80A Al Thawra Street, Heliopolis, 11341 Cairo, Egypt. Electronic address: drheshamhelal@med.asu.edu.eg.'}, {'ForeName': 'Nada A', 'Initials': 'NA', 'LastName': 'Mahmoud', 'Affiliation': 'Plastic and Reconstructive Surgery Department, Faculty of Medicine, Ain-Shams University, 80A Al Thawra Street, Heliopolis, 11341 Cairo, Egypt.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.05.034'] 2289,31345717,A Novel Speckle-Tracking Based Method for Quantifying Tricuspid Annular Velocities in TEE.,"OBJECTIVES A novel speckle-tracking-based option for measuring tricuspid annular velocities in the midesophageal 4-chamber view (ME4C) was compared with velocities measured by tissue Doppler in the apical-4 chamber view (AP4C). Because this method was based on a modified speckle-tracking-based measurement of tricuspid annular plane systolic excursion (TAPSE), the authors also compared TAPSE by speckle tracking in the ME4C with TAPSE by M-mode in the AP4C. The authors hypothesized that velocities measured by speckle tracking in transesophageal echocardiography (TEE) would be similar, correlate, and agree with those measured by tissue Doppler in transthoracic echocardiography (TTE). DESIGN Prospective diagnostic study with randomization of the order of post-induction echocardiography views by TTE (AP4C) and TEE (ME4C). Images were both acquired and analyzed by 2 echocardiographers independently. The primary outcome was S'; secondary outcomes were E', A', and TAPSE. SETTING Single university hospital. PARTICIPANTS Consecutive adult patients undergoing cardiac surgery (mainly coronary artery bypass grafting). INTERVENTIONS None. MAIN RESULTS Complete data was available in 24 of 25 patients. For the primary outcome, S' measured by speckle tracking in the ME4C correlated and agreed with S' measured by tissue Doppler in the AP4C (S' STE  = 0.87S TDI  + 0.60, p < 0.001, r = 0.78; mean bias -0.6 cm/s, 95% limits of agreement (LoA) -3.5 to 2.4 cm/s). Similarly results were found for E', but not A' (E' STE  = 0.69E' TDI  + 2.37, p < 0.001, r = 0.71; mean bias 0.1 cm/s, 95%LoA -2.5 to 2.8cm/s; A' STE  = 0.15A' TDI  + 11.17, p = 0.629). TAPSE measurements by the authors' modified speckle-tracking-based technique were similar to TAPSE by M-mode (18.2 ± 5.5 mm and 17.1 ± 3.9 mm, respectively). CONCLUSIONS Tricuspid annular velocities (S' STE , E' STE ) determined by speckle tracking in TEE seem to be promising surrogates for velocities measured in TTE. This may be important for perioperative assessment of the right ventricle.",2019,"For the primary outcome, S' measured by speckle tracking in the ME4C correlated and agreed with S' measured by tissue Doppler in the AP4C (S' STE  = 0.87S TDI  + 0.60, p < 0.001, r = 0.78; mean bias -0.6 cm/s, 95% limits of agreement (LoA) -3.5 to 2.4 cm/s).","['Single university hospital', 'Consecutive adult patients undergoing cardiac surgery (mainly coronary artery bypass grafting']",['post-induction echocardiography views by TTE (AP4C) and TEE (ME4C'],"[""S' measured by speckle tracking in the ME4C correlated and agreed with S' measured by tissue Doppler"", 'TAPSE measurements', ""S'; secondary outcomes were E', A', and TAPSE""]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0402267,"For the primary outcome, S' measured by speckle tracking in the ME4C correlated and agreed with S' measured by tissue Doppler in the AP4C (S' STE  = 0.87S TDI  + 0.60, p < 0.001, r = 0.78; mean bias -0.6 cm/s, 95% limits of agreement (LoA) -3.5 to 2.4 cm/s).","[{'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Mauermann', 'Affiliation': 'Department for Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium; Department for Anesthesiology, Surgical Intensive Care, Prehospital Emergency Medicine, and Pain Therapy, Basel University Hospital, Basel, Switzerland. Electronic address: Eckhard.Mauermann@usb.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vandenheuvel', 'Affiliation': 'Department for Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'François', 'Affiliation': 'Department of Cardiac Surgery, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Bouchez', 'Affiliation': 'Department for Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wouters', 'Affiliation': 'Department for Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.05.036'] 2290,32576237,Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: study protocol for a randomized controlled trial.,"BACKGROUND Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested, owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the present study is to evaluate the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV. METHODS/DESIGN One hundred eligible participants with AV will be randomly assigned to an acupuncture or a sham acupuncture group (1:1 allocation). All participants will receive 4-week treatment comprising a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, visual analogue scale scores for assessment of itch and pain, patient expectations of acupuncture, and blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. DISCUSSION We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single-center scope, relatively small sample size, and lack of blinding of the acupuncturists. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR-1900023649. Registered on January 2, 2019.",2020,"The secondary outcomes will be Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, visual analogue scale scores for assessment of itch and pain, patient expectations of acupuncture, and blinding of the effect of sham acupuncture.","['patients with moderate or severe AV', 'One hundred eligible participants with AV', 'patients with AV', 'patients with moderate or severe acne vulgaris']","['acupuncture therapy', 'acupuncture', 'sham acupuncture', 'acupuncture or a\xa0sham acupuncture']","['quality of life', 'Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, visual analogue scale scores for assessment of itch and pain, patient expectations of acupuncture, and blinding of the effect of sham acupuncture', 'Skindex-16 scale total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",100.0,0.311021,"The secondary outcomes will be Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, visual analogue scale scores for assessment of itch and pain, patient expectations of acupuncture, and blinding of the effect of sham acupuncture.","[{'ForeName': 'Ruimin', 'Initials': 'R', 'LastName': 'Jiao', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, China.""}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, China.""}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, China.""}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, China. liuzhishun@aliyun.com.""}]",Trials,['10.1186/s13063-020-04346-7'] 2291,32576243,The cerebral mechanism of the specific and nonspecific effects of acupuncture based on knee osteoarthritis: study protocol for a randomized controlled trial.,"BACKGROUND Research on the effect of acupuncture has been limited. Whether the effect of acupuncture is equivalent to placebo has been the focus of debate in this field. This study will explore the specific and non-specific effects of acupuncture for knee osteoarthritis (KOA) by functional magnetic resonance imaging (fMRI). METHODS AND DESIGN Ninety participants diagnosed with KOA will be randomly divided into the acupuncture group, sham acupuncture group, and waiting list group in a ratio of 1:1:1. Except for the waiting list group, the other participants will receive acupuncture or sham acupuncture three sessions per week for 4 weeks respectively. The primary outcome will be the response rate which is defined on an individual basis as at least a 2-point decrease in the numerical rating scale (NRS) of pain at the end of intervention period compared with the baseline. fMRI scans will be performed at baseline and the end of the intervention period to examine the response of various brain regions. The secondary outcomes will include the Western Ontario and McMaster Osteoarthritis Index (WOMAC), State-Trait Anxiety Scale-State Anxiety Subscale (STAI-S), and Stanford Expectations of Treatment Scale (SETS). Pearson's correlation coefficient will be performed to investigate the changes in brain activity and clinical variables. DISCUSSION The results of our study will help to evaluate the specific and nonspecific effects of acupuncture combined with clinical and brain function changes based on KOA. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1900025799. Registered on 9 September 2019.",2020,"The secondary outcomes will include the Western Ontario and McMaster Osteoarthritis Index (WOMAC), State-Trait Anxiety Scale-State Anxiety Subscale (STAI-S), and Stanford Expectations of Treatment Scale (SETS).",['Ninety participants diagnosed with KOA'],"['acupuncture', 'acupuncture group, sham acupuncture', 'functional magnetic resonance imaging (fMRI', 'acupuncture or sham acupuncture', 'placebo']","['response rate which is defined on an individual basis as at least a 2-point decrease in the numerical rating scale (NRS) of pain', 'Western Ontario and McMaster Osteoarthritis Index (WOMAC), State-Trait Anxiety Scale-State Anxiety Subscale (STAI-S), and Stanford Expectations of Treatment Scale (SETS']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",90.0,0.170792,"The secondary outcomes will include the Western Ontario and McMaster Osteoarthritis Index (WOMAC), State-Trait Anxiety Scale-State Anxiety Subscale (STAI-S), and Stanford Expectations of Treatment Scale (SETS).","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shandong University of Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Jin-Ling', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Yan', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Life Sciences, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'You-Sheng', 'Initials': 'YS', 'LastName': 'Qi', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, China.'}, {'ForeName': 'Jun-Hong', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China. wangliqiongwork@163.com.'}]",Trials,['10.1186/s13063-020-04518-5'] 2292,32576247,Evaluating hearing performance with cochlear implants within the same patient using daily randomization and imaging-based fitting - The ELEPHANT study.,"BACKGROUND Prospective research in the field of cochlear implants is hampered by methodological issues and small sample sizes. The ELEPHANT study presents an alternative clinical trial design with a daily randomized approach evaluating individualized tonotopical fitting of a cochlear implant (CI). METHODS A single-blinded, daily-randomized clinical trial will be implemented to evaluate a new imaging-based CI mapping strategy. A minimum of 20 participants will be included from the start of the rehabilitation process with a 1-year follow-up period. Based on a post-operative cone beam CT scan (CBCT), mapping of electrical input will be aligned to natural place-pitch arrangement in the individual cochlea. The CI's frequency allocation table will be adjusted to match the electrical stimulation of frequencies as closely as possible to corresponding acoustic locations in the cochlea. A randomization scheme will be implemented whereby the participant, blinded to the intervention allocation, crosses over between the experimental and standard fitting program on a daily basis, and thus effectively acts as his own control, followed by a period of free choice between both maps to incorporate patient preference. With this new approach the occurrence of a first-order carryover effect and a limited sample size is addressed. DISCUSSION The experimental fitting strategy is thought to give rise to a steeper learning curve, result in better performance in challenging listening situations, improve sound quality, better complement residual acoustic hearing in the contralateral ear and be preferred by recipients of a CI. Concurrently, the suitability of the novel trial design will be considered in investigating these hypotheses. TRIAL REGISTRATION ClinicalTrials.gov: NCT03892941. Registered 27 March 2019.",2020,"The experimental fitting strategy is thought to give rise to a steeper learning curve, result in better performance in challenging listening situations, improve sound quality, better complement residual acoustic hearing in the contralateral ear and be preferred by recipients of a CI.",['20 participants will be included from the start of the rehabilitation process with a 1-year follow-up period'],['post-operative cone beam CT scan (CBCT'],['hearing performance'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}]",,0.163225,"The experimental fitting strategy is thought to give rise to a steeper learning curve, result in better performance in challenging listening situations, improve sound quality, better complement residual acoustic hearing in the contralateral ear and be preferred by recipients of a CI.","[{'ForeName': 'L J G', 'Initials': 'LJG', 'LastName': 'Lambriks', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands. lars.lambriks@mumc.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Hoof', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Debruyne', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Janssen', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chalupper', 'Affiliation': 'Advanced Bionics European Research Centre (AB ERC), Hannover, Germany.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'van der Heijden', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Hof', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Hellingman', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'E L J', 'Initials': 'ELJ', 'LastName': 'George', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'E M J', 'Initials': 'EMJ', 'LastName': 'Devocht', 'Affiliation': 'Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Trials,['10.1186/s13063-020-04469-x'] 2293,32576258,"Parasite clearance, cure rate, post-treatment prophylaxis and safety of standard 3-day versus an extended 6-day treatment of artemether-lumefantrine and a single low-dose primaquine for uncomplicated Plasmodium falciparum malaria in Bagamoyo district, Tanzania: a randomized controlled trial.","BACKGROUND Artemisinin-based combination therapy (ACT) resistant Plasmodium falciparum represents an increasing threat to Africa. Extended ACT regimens from standard 3 to 6 days may represent a means to prevent its development and potential spread in Africa. METHODS Standard 3-day treatment with artemether-lumefantrine (control) was compared to extended 6-day treatment and single low-dose primaquine (intervention); in a randomized controlled, parallel group, superiority clinical trial of patients aged 1-65 years with microscopy confirmed uncomplicated P. falciparum malaria, enrolled in Bagamoyo district, Tanzania. The study evaluated parasite clearance, including proportion of PCR detectable P. falciparum on days 5 and 7 (primary endpoint), cure rate, post-treatment prophylaxis, safety and tolerability. Clinical, and laboratory assessments, including ECG were conducted during 42 days of follow-up. Blood samples were collected for parasite detection (by microscopy and PCR), molecular genotyping and pharmacokinetic analyses. Kaplan-Meier survival analyses were done for both parasite clearance and recurrence. RESULTS A total of 280 patients were enrolled, 141 and 139 in the control and intervention arm, respectively, of whom 121 completed 42 days follow-up in each arm. There was no difference in proportion of PCR positivity across the arms at day 5 (80/130 (61.5%) vs 89/134 (66.4%), p = 0.44), or day 7 (71/129 (55.0%) vs 70/134 (52.2%), p = 0.71). Day 42 microscopy determined cure rates (PCR adjusted) were 97.4% (100/103) and 98.3% (110/112), p = 0.65, in the control and intervention arm, respectively. Microscopy determined crude recurrent parasitaemia during follow-up was 21/121 (17.4%) in the control and 14/121 (11.6%) in the intervention arm, p = 0.20, and it took 34 days and 42 days in the respective arms for 90% of the patients to remain without recurrent parasitaemia. Lumefantrine exposure was significantly higher in intervention arm from D3 to D42, but cardiac, biochemical and haematological safety was high and similar in both arms. CONCLUSION Extended 6-day artemether-lumefantrine treatment and a single low-dose of primaquine was not superior to standard 3-day treatment for ACT sensitive P. falciparum infections but, importantly, equally efficacious and safe. Thus, extended artemether-lumefantrine treatment may be considered as a future treatment regimen for ACT resistant P. falciparum, to prolong the therapeutic lifespan of ACT in Africa. Trial registration ClinicalTrials.gov, NCT03241901. Registered July 27, 2017 https://clinicaltrials.gov/show/NCT03241901.",2020,"Microscopy determined crude recurrent parasitaemia during follow-up was 21/121 (17.4%) in the control and 14/121 (11.6%) in the intervention arm, p = 0.20, and it took 34 days and 42 days in the respective arms for 90% of the patients to remain without recurrent parasitaemia.","['patients aged 1-65\xa0years with microscopy confirmed uncomplicated P. falciparum malaria, enrolled in Bagamoyo district, Tanzania', 'uncomplicated Plasmodium falciparum malaria in Bagamoyo district, Tanzania', 'A total of 280 patients were enrolled, 141 and 139 in the control and intervention arm, respectively, of whom 121 completed 42\xa0days follow-up in each arm']","['artemether-lumefantrine (control', 'artemether-lumefantrine and a single low-dose primaquine', 'extended 6-day treatment and single low-dose primaquine (intervention', 'primaquine']","['cure rates (PCR adjusted', 'cardiac, biochemical and haematological safety', 'Lumefantrine exposure', 'Microscopy determined crude recurrent parasitaemia', 'Parasite clearance, cure rate', 'proportion of PCR positivity', 'cure rate, post-treatment prophylaxis, safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0024535', 'cui_str': 'Falciparum malaria'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]",280.0,0.311455,"Microscopy determined crude recurrent parasitaemia during follow-up was 21/121 (17.4%) in the control and 14/121 (11.6%) in the intervention arm, p = 0.20, and it took 34 days and 42 days in the respective arms for 90% of the patients to remain without recurrent parasitaemia.","[{'ForeName': 'Lwidiko E', 'Initials': 'LE', 'LastName': 'Mhamilawa', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden. lwidiko.edward@kbh.uu.se.""}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Ngasala', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Morris', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eliford Ngaimisi', 'Initials': 'EN', 'LastName': 'Kitabi', 'Affiliation': 'Office of Clinical Pharmacology, Division of Pharmacometrics, Food and Drugs Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Barnes', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Aung Paing', 'Initials': 'AP', 'LastName': 'Soe', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Bruno P', 'Initials': 'BP', 'LastName': 'Mmbando', 'Affiliation': 'Tanga Centre, National Institute for Medical Research, Tanga, Tanzania.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Björkman', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mårtensson', 'Affiliation': ""Department of Women's and Children's Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden.""}]",Malaria journal,['10.1186/s12936-020-03287-5'] 2294,32576350,[Study on patient-ventilator synchrony of neurally adjusted ventilatory assist ventilation in severe neurological diseases patients with tracheotomy].,"OBJECTIVE To explore the patient-ventilator interaction of neurally adjusted ventilatory assist (NAVA) in patients with severe neurological diseases. METHODS A prospective study was conducted. Sixteen severe neurological patients with tracheotomy admitted to neurosurgery intensive care unit (NSICU) of Yijishan Hospital of the First Affiliated Hospital of Wannan Medical College from September 2019 to February 2020 were enrolled. According to the random number table method, they were treated with pressure support ventilation (PSV) mode followed by NAVA mode or NAVA mode followed by PSV mode mechanical ventilation. Each mode was ventilated for 24 hours. The number of auto-triggering, ineffective trigger, double trigger, inspiratory trigger delay, premature cycling, late cycling, and patient-ventilator asynchronous time (inspiratory trigger delay time, premature cycling time, and late cycling time) within 1 minute were recorded every 8 hours for 3 minutes. The average number of asynchronies per minute, asynchrony index (AI), total AI, asynchrony time, arterial blood gas analysis, and coefficient variation (CV%) of respiratory mechanics parameters of each asynchrony type between the two modes were compared. RESULTS There were significant decrease in the number or AI of auto-triggering, ineffective trigger, inspiratory trigger delay, premature cycling, and late cycling with NAVA mode ventilation compared with PSV mode ventilation [auto-triggering times (times/min): 0.00 (0.00, 0.00) vs. 0.00 (0.00, 0.58), auto-triggering AI: 0.00 (0.00, 0.00) vs. 0.00 (0.00, 0.02), ineffective trigger times (times/min): 0.00 (0.00, 0.33) vs. 1.00 (0.33, 2.17), ineffective trigger AI: 0.00 (0.00, 0.02) vs. 0.05 (0.02, 0.09), inspiratory trigger delay times (times/min): 0.00 (0.00, 0.58) vs. 0.67 (0.33, 1.58), inspiratory trigger delay AI: 0.00 (0.00, 0.02) vs. 0.05 (0.02, 0.09), premature cycling times (times/min): 0.00 (0.00, 0.33) vs. 0.33 (0.08, 1.00), premature cycling AI: 0.00 (0.00, 0.01) vs. 0.02 (0.00, 0.05), late cycling times (times/min): 0.00 (0.00, 0.00) vs. 1.17 (0.00, 4.83), late cycling AI: 0.00 (0.00, 0.00) vs. 0.07 (0.00, 0.25), all P < 0.05]. But there was significant increase in the number or AI of double trigger with NAVA mode ventilation as compared with PSV mode ventilation [times (times/min): 1.00 (0.33, 2.00) vs. 0.00 (0.00, 0.00), AI: 0.04 (0.02, 0.11) vs. 0.00 (0.00, 0.00), both P < 0.05]. Total AI and incidence of total AI > 0.1 showed significant decrease during NAVA mode ventilation as compared with PSV mode ventilation [total AI: 0.08 (0.04, 0.14) vs. 0.22 (0.18, 0.46), incidence of total AI > 0.1: 37.50% (6/16) vs. 93.75% (15/16), both P < 0.01]. There was no significant difference in asynchronous time or arterial blood gas analysis between the two modes. There were significant increases in variances of peak airway pressure (Ppeak) and expiratory tidal volume (VTe) during NAVA mode ventilation as compared with PSV mode ventilation [Ppeak coefficient of variation (CV%): 11.25 (7.12, 15.17)% vs. 0.00 (0.00, 2.82)%, VTe CV%: (8.93±5.53)% vs. (4.71±2.61)%, both P < 0.05]. CONCLUSIONS Compared with PSV mode, NAVA mode can reduce the occurrence of patient-ventilator asynchronous events, reduce the AI and the occurrence of serious patient-ventilator asynchronous events, so as to improve the patient-ventilator interaction. NAVA and PSV modes can achieve the same gas exchange effect. At the same time, NAVA mode has potential advantages in avoiding insufficient or excessive ventilation support, diaphragm protection and prevention of ventilator-induced lung injury.",2020,"There were significant increases in variances of peak airway pressure (Ppeak) and expiratory tidal volume (VTe) during NAVA mode ventilation as compared with PSV mode ventilation [Ppeak coefficient of variation (CV%): 11.25 (7.12, 15.17)% vs. 0.00","['patients with severe neurological diseases', 'Sixteen severe neurological patients with tracheotomy admitted to neurosurgery intensive care unit (NSICU) of Yijishan Hospital of the First Affiliated Hospital of Wannan Medical College from September 2019 to February 2020 were enrolled', 'severe neurological diseases patients with tracheotomy']","['neurally adjusted ventilatory assist ventilation', 'neurally adjusted ventilatory assist (NAVA', 'pressure support ventilation (PSV) mode followed by NAVA mode or NAVA mode followed by PSV mode mechanical ventilation']","['late cycling times', 'Total AI and incidence of total AI', 'inspiratory trigger delay times', 'number of auto-triggering, ineffective trigger, double trigger, inspiratory trigger delay, premature cycling, late cycling, and patient-ventilator asynchronous time (inspiratory trigger delay time, premature cycling time, and late cycling time', 'premature cycling times', 'number or AI of auto-triggering, ineffective trigger, inspiratory trigger delay, premature cycling, and late cycling with NAVA mode ventilation', 'variances of peak airway pressure (Ppeak) and expiratory tidal volume (VTe', 'inspiratory trigger delay AI', 'average number of asynchronies per minute, asynchrony index (AI), total AI, asynchrony time, arterial blood gas analysis, and coefficient variation (CV%) of respiratory mechanics parameters', 'ineffective trigger times', 'number or AI of double trigger with NAVA mode ventilation', 'asynchronous time or arterial blood gas analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0151064,"There were significant increases in variances of peak airway pressure (Ppeak) and expiratory tidal volume (VTe) during NAVA mode ventilation as compared with PSV mode ventilation [Ppeak coefficient of variation (CV%): 11.25 (7.12, 15.17)% vs. 0.00","[{'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery Intensive Care Unit, Yijishan Hospital, the First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Intervention, Wuhu Second People's Hospital, Wuhu 241000, Anhui, China. Corresponding author: Yu Tao, Email: yutao201103@gmail.com.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery Intensive Care Unit, Yijishan Hospital, the First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Neurosurgery Intensive Care Unit, Yijishan Hospital, the First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China.'}, {'ForeName': 'Guiliang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery Intensive Care Unit, Yijishan Hospital, the First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Neurosurgery Intensive Care Unit, Yijishan Hospital, the First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China.'}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Neurosurgery Intensive Care Unit, Yijishan Hospital, the First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China.'}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200427-00341'] 2295,32576351,[Application of acute physiology and chronic health evaluation II score in the timing of noninvasive ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease].,"OBJECTIVE To explore the application of acute physiology and chronic health evaluation II (APACHE II) score in the timing and nursing of noninvasive ventilation for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). METHODS 106 AECOPD patients admitted to Haikou People's Hospital from January 2018 to October 2019 were selected as the study objects. According to the method of random number table, the patients were divided into observation group and control group, with 53 patients in each group. The control group selected the timing of noninvasive ventilation treatment according to the standards of Mechanical ventilation (second edition), weaned according to Clinical practice of mechanical ventilation, and received routine nursing in intensive care unit (ICU), including creating comfortable indoor environment, reasonable diet, condition monitoring, psychological nursing and complications nursing. On the basis of the control group, the patients in the observation group were given noninvasive ventilation when APACHE II score was more than 10, and were weaned when APACHE II score was less than or equal to 10. According to APACHE II score < 10, 10-14, 15-19 and ≥ 20, the patients were given level-3 care, level-2 care, level-1 care and intensive care. The pulmonary function before and 3 days after the noninvasive ventilation treatment was monitored, and the duration of mechanical ventilation, the length of ICU stay, endotracheal intubation rate, incidence of complication [ventilator associated pneumonia (VAP)] and ICU mortality were recorded. The self-designed questionnaire of nursing satisfaction was used to evaluate the patients' nursing satisfaction. RESULTS There was no significant difference in general data such as gender or age between the two groups. After 3 days of noninvasive ventilation, the forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio of the two groups were increased significantly as compared with those before treatment, especially in the observation group, with statistical significances as compared with the control group [FEV1 (L): 3.02±0.22 vs. 2.54±0.19, FVC (L): 3.01±0.32 vs. 2.13±0.28, FEV1/FVC ratio: 0.89±0.08 vs. 0.79±0.08, all P < 0.05]. Compared with the control group, the duration of mechanical ventilation and length of ICU stay in the observation group were significantly shortened [duration of mechanical ventilation (days): 4.32±0.73 vs. 8.42±1.94, length of ICU stay (hours): 32.23±10.22 vs. 38.52±9.85, both P < 0.01]. The intubation rate, incidence of VAP and ICU mortality in the observation group were significantly lower than those in the control group [intubation rate: 1.9% (1/53) vs. 13.2% (7/53), incidence of VAP: 1.9% (1/53) vs. 15.1% (8/53), ICU mortality: 1.9% (1/53) vs. 13.2% (7/53), all P < 0.05]. The nursing satisfaction of patients in the observation group was significantly higher than that in the control group [96.2% (51/53) vs. 75.5% (40/53), P < 0.01]. CONCLUSIONS APACHE II score can be used to guide the choice of noninvasive ventilation treatment opportunity and nursing intervention measures for AECOPD patients. It can significantly improve the pulmonary function of patients, improve the treatment effect, reduce the incidence of complications, and improve the satisfaction of patients with nursing, which is effective in clinical application.",2020,"The intubation rate, incidence of VAP and ICU mortality in the observation group were significantly lower than those in the control group [intubation rate: 1.9% (1/53) vs. 13.2% (7/53), incidence of VAP: 1.9% (1/53) vs. 15.1% (8/53), ICU mortality: 1.9% (1/53) vs. 13.2% (7/53), all P < 0.05].","['patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD', 'AECOPD patients', ""106 AECOPD patients admitted to Haikou People's Hospital from January 2018 to October 2019 were selected as the study objects"", 'patients with acute exacerbation of chronic obstructive pulmonary disease']","['noninvasive ventilation', 'noninvasive ventilation treatment according to the standards of Mechanical ventilation (second edition), weaned according to Clinical practice of mechanical ventilation, and received routine nursing in intensive care unit (ICU), including creating comfortable indoor environment, reasonable diet, condition monitoring, psychological nursing and complications nursing']","['duration of mechanical ventilation, the length of ICU stay, endotracheal intubation rate, incidence of complication [ventilator associated pneumonia (VAP)] and ICU mortality', 'intubation rate, incidence of VAP and ICU mortality', 'forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio', 'nursing satisfaction', 'incidence of VAP', 'ICU mortality', 'pulmonary function', 'duration of mechanical ventilation and length of ICU stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",106.0,0.0268742,"The intubation rate, incidence of VAP and ICU mortality in the observation group were significantly lower than those in the control group [intubation rate: 1.9% (1/53) vs. 13.2% (7/53), incidence of VAP: 1.9% (1/53) vs. 15.1% (8/53), ICU mortality: 1.9% (1/53) vs. 13.2% (7/53), all P < 0.05].","[{'ForeName': 'Jumei', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Central South University Xiangya School of Medicine Affiliated Haikou Hospital (Haikou People's Hospital), Haikou 570208, Hainan, China. Corresponding author: Zeng Cimei, Email: chenhushi980@126.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wanrong', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Qionge', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Cimei', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200106-00159'] 2296,32576447,Lung clearance index-triggered intervention in children with cystic fibrosis - A randomised pilot study.,"HYPOTHESIS Using increase in the lung clearance index (LCI) as a trigger for bronchoalveolar lavage (BAL) and associated antimicrobial treatment might benefit clinical outcomes in children with cystic fibrosis (CF). METHODS A 2-year, longitudinal, interventional, randomized, controlled pilot study with quarterly visits in 5-18 years old children with CF. LCI and z-scores for the forced expired volume in 1 s (zFEV 1 ) and body mass index (zBMI) were obtained at every visit, CF Questionnaire-revised (CFQ-R) yearly and BAL and chest computed tomography at first and last visit. Children in the intervention group had BAL performed if LCI increased >1 unit from a fixed baseline value established at first visit. If the presence of a pathogen was documented in the BAL fluid, treatment was initiated/altered accordingly. RESULTS Twenty-nine children with CF were randomized to the control (n = 14) and intervention group (n = 15). The median (interquartile range) number of BAL procedures per child was 2.5 (2.0; 3.0) and 6.0 (4.0; 7.0) in the control and intervention group, respectively. There was no significant difference between groups in slope for the primary outcome LCI; difference was 0.21 (95% confidence interval: -0.45; 0.88) units/year. Likewise, there was no significant difference between groups in slope for the secondary outcomes zFEV 1 , zBMI, CFQ-R respiratory symptom score and the proportion of total disease and trapped air on chest computed tomography. CONCLUSIONS LCI-triggered BAL and associated antimicrobial treatment did not benefit clinical outcomes in a small cohort of closely monitored school-age children with CF.",2020,There was no significant difference between groups in slope for the primary outcome LCI; difference was 0.21,"['children with cystic fibrosis', 'children with cystic fibrosis (CF', 'Twenty-nine children with CF', 'quarterly visits in 5-18 years old children with CF']","['Lung clearance index-triggered intervention', 'LCI-triggered BAL']","['lung clearance index (LCI', 'zBMI, CFQ-R respiratory symptom score and the proportion of total disease and trapped air on chest computed tomography', 'body mass index (zBMI', 'LCI and z-scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}]","[{'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",29.0,0.12095,There was no significant difference between groups in slope for the primary outcome LCI; difference was 0.21,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Voldby', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Green', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kongstad', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Astrid Madsen', 'Initials': 'AM', 'LastName': 'Ring', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Rikke Mulvad', 'Initials': 'RM', 'LastName': 'Sandvik', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Skov', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Buchvald', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Tacjana', 'Initials': 'T', 'LastName': 'Pressler', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark; CF Centre Copenhagen, Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Kim Gjerum', 'Initials': 'KG', 'LastName': 'Nielsen', 'Affiliation': 'CF Centre Copenhagen, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark. Electronic address: kim.g.nielsen@regionh.dk.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.06.010'] 2297,32576483,Changes in Sleep Duration and Timing During the Middle-to-High School Transition.,"PURPOSE The purpose of the study was to quantify changes in sleep during the middle-to-high school transition and determine if changes in sleep differ by sociodemographic characteristics. METHODS Adolescents were enrolled in eighth grade and followed into ninth grade (N = 110; 2,470 nights observed). The outcomes were actigraphy-estimated sleep duration, sleep onset, sleep offset, and sleep sufficiency (≥8 hours of sleep). The exposures were school grade (eighth or ninth), school night status (school or nonschool), sex (female or male), and race (white, black, or other). RESULTS On school nights, sleep duration declined by 25.8 minutes per night (p < .001) from eighth to ninth grade. There was no change in sleep duration on nonschool nights. Timing of sleep onset was 22.2 minutes later on school nights (p < .001) and 17.4 minutes later on nonschool nights (p < .001) in ninth grade. Timing of sleep offset did not change on school mornings but was 22.2 minutes later on nonschool mornings (p < .001) in ninth grade. The proportion of school nights (and nonschool nights) with sleep duration ≥8 hours was 9.4% (38.3%) in eighth grade and 5.7% (35.9%) in ninth grade. The odds of sleeping ≥8 hours per night was 42% lower in ninth grade, compared toeighth grade (odds ratio = .58; 95% confidence interval: .37, .91). Males were 59% less likely to sleep ≥8 hours per night. Black adolescents were 51% less likely to sleep ≥8 hours per night. CONCLUSIONS Insufficient sleep is highly prevalent, especially on school nights and among male and black adolescents, and this problem worsens with the transition to high school.",2020,"On school nights, sleep duration declined by 25.8 minutes per night (p < .001) from eighth to ninth grade.","['Adolescents were enrolled in eighth grade and followed into ninth grade (N\xa0= 110; 2,470 nights observed', 'male and black adolescents', 'Black adolescents']",[],"['actigraphy-estimated sleep duration, sleep onset, sleep offset, and sleep sufficiency (≥8\xa0hours of sleep', 'proportion of school nights (and nonschool nights) with sleep duration', 'school grade (eighth or ninth), school night status (school or nonschool), sex (female or male), and race (white, black, or other', 'sleep duration']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]",[],"[{'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]",,0.0236207,"On school nights, sleep duration declined by 25.8 minutes per night (p < .001) from eighth to ninth grade.","[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Mitchell', 'Affiliation': ""Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. Electronic address: mitchellj2@email.chop.edu.""}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Williamson', 'Affiliation': ""Sleep Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; PolicyLab, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Huffnagle', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ludwick', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Struan F A', 'Initials': 'SFA', 'LastName': 'Grant', 'Affiliation': ""Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Human Genetics, Center for Spatial and Functional Genomics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Babette A', 'Initials': 'BA', 'LastName': 'Zemel', 'Affiliation': ""Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.04.024'] 2298,32572020,Acute oxytocin effects in inferring others' beliefs and social emotions in people at clinical high risk for psychosis.,"Social deficits are key hallmarks of the Clinical High Risk for Psychosis (CHR-P) state and of established psychotic disorders, and contribute to impaired social functioning, indicating a potential target for interventions. However, current treatments do not significantly ameliorate social impairments in CHR-P individuals. Given its critical role in social behaviour and cognition, the oxytocinergic (OT) system is a promising target for novel interventions in CHR-P subjects. In a double-blind, placebo-controlled, crossover design, 30 CHR-P males were studied using functional magnetic resonance imaging (fMRI) on two occasions, once after 40IU self-administered intranasal OT and once after placebo. A modified version of the Sally-Anne task was used to assess brain activation during inferring others' beliefs and social emotions. The Reading the Mind in the Eyes Test was acquired prior to the first scan to test whether OT effects were moderated by baseline social-emotional abilities. OT did not modulate behavioural performances but reduced activation in the bilateral inferior frontal gyrus compared with placebo while inferring others' social emotions. Furthermore, the relationship between brain activation and task performance after OT administration was moderated by baseline social-emotional abilities. While task accuracy during inferring others' social emotion increased with decreasing activation in the left inferior frontal gyrus in CHR-P individuals with low social-emotional abilities, there was no such relationship in CHR-P individuals with high social-emotional abilities. Our findings may suggest that acute OT administration enhances neural efficiency in the inferior frontal gyrus during inferring others' social emotions in those CHR-P subjects with low baseline social-emotional abilities.",2020,OT did not modulate behavioural performances but reduced activation in the bilateral inferior frontal gyrus compared with placebo while inferring others' social emotions.,"['CHR-P subjects', 'people at clinical high risk for psychosis', '30 CHR-P males']","['OT', 'functional magnetic resonance imaging (fMRI', 'placebo']","['brain activation', 'brain activation and task performance', 'social impairments', 'neural efficiency']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0633367,OT did not modulate behavioural performances but reduced activation in the bilateral inferior frontal gyrus compared with placebo while inferring others' social emotions.,"[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, Switzerland. andre.schmidt@unibas.ch.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Micheli', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ramella-Cravaro', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Provenzani', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Aoki', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Rutigliano', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cappucciati', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Murguia', 'Affiliation': 'Tower Hamlets Early Detection Service (THEDS), East London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sukhi', 'Initials': 'S', 'LastName': 'Shergill', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Morrison', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': ""Institute of Pharmaceutical Science, King's College London, London, UK.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yamasue', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fusar-Poli', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]",Translational psychiatry,['10.1038/s41398-020-00885-4'] 2299,32572100,Traditional versus blended CPR training program: A randomized controlled non-inferiority study.,"Cardiopulmonary resuscitation (CPR) training and its quality are critical in improving the survival rate of cardiac arrest. This randomized controlled study investigated the efficacy of a newly developed CPR training program for the public in a Taiwanese setting. A total of 832 adults were randomized to either a traditional or blended (18-minute e-learning plus 30-minute hands-on) compression-only CPR training program. The primary outcome was compression depth. Secondary outcomes included CPR knowledge test, practical test, quality of CPR performance, and skill retention. The mean compression depth was 5.21 cm and 5.24 cm in the blended and traditional groups, respectively. The mean difference in compression depth between groups was -0.04 (95% confidence interval -0.13 to infinity), demonstrating that the blended CPR training program was non-inferior to the traditional CPR training program in compression depth after initial training. Secondary outcome results were comparable between groups. Although the mean compression depth and rate were guideline-compliant, only half of the compressions were delivered with adequate depth and rate in both groups. CPR knowledge and skill retained similarly in both groups at 6 and 12 months after training. The blended CPR training program was non-inferior to the traditional CPR training program. However, there is still room for improvement in optimizing initial skill performance as well as skill retention. Clinical Trial Registration: NCT03586752; www.clinicaltrial.gov.",2020,The mean difference in compression depth between groups was -0.04,['832 adults'],"['traditional or blended (18-minute e-learning plus 30-minute hands-on) compression-only CPR training program', 'Traditional versus blended CPR training program', 'blended CPR training program', 'CPR training program', 'Cardiopulmonary resuscitation (CPR) training']","['compression depth', 'mean compression depth', 'CPR knowledge and skill', 'CPR knowledge test, practical test, quality of CPR performance, and skill retention', 'mean compression depth and rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",832.0,0.0353797,The mean difference in compression depth between groups was -0.04,"[{'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Chien', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Shao-Yu', 'Initials': 'SY', 'LastName': 'Fang', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital Taipei Branch, Taipei, 105, Taiwan.'}, {'ForeName': 'Li-Heng', 'Initials': 'LH', 'LastName': 'Tsai', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Shang-Li', 'Initials': 'SL', 'LastName': 'Tsai', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chen-Bin', 'Initials': 'CB', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chen-June', 'Initials': 'CJ', 'LastName': 'Seak', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Weng', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chi-Chun', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Wei-Che', 'Initials': 'WC', 'LastName': 'Chien', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chien-Hsiung', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Ton-Yen General Hospital, Zhubei, 302, Taiwan.'}, {'ForeName': 'Chung-Hsien', 'Initials': 'CH', 'LastName': 'Chaou', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Peng-Huei', 'Initials': 'PH', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Hsiao-Jung', 'Initials': 'HJ', 'LastName': 'Tseng', 'Affiliation': 'Biostatistics Unit, Clinical Trial Center, Chang Gung Memorial Hospital, Linkou, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Jih-Chang', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Peng', 'Affiliation': 'Department of nursing, Ton-Yen General Hospital, Zhubei, 302, Taiwan.'}, {'ForeName': 'Tsung-Hsuan', 'Initials': 'TH', 'LastName': 'Cheng', 'Affiliation': 'Department of nursing, Ton-Yen General Hospital, Zhubei, 302, Taiwan.'}, {'ForeName': 'Kuang-Hung', 'Initials': 'KH', 'LastName': 'Hsu', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan.'}, {'ForeName': 'Chip-Jin', 'Initials': 'CJ', 'LastName': 'Ng', 'Affiliation': 'Department of Emergency Medicine, Chang Gung Memorial Hospital, Linkou and College of Medicine, Chang Gung University, Taoyuan, 333, Taiwan. ngowl@ms3.hinet.net.'}]",Scientific reports,['10.1038/s41598-020-67193-1'] 2300,32572525,Perioperative Management and Outcomes of Hyperthyroid Patients Unable to Tolerate Antithyroid Drugs.,"BACKGROUND Prior to thyroidectomy for hyperthyroidism, it is recommended that patients are managed with antithyroid drugs (ATDs) and rendered euthyroid to decrease the risk of thyroid storm. However, not all patients tolerate ATD and the risk of thyroid storm during thyroidectomy in these patients is unclear. Therefore, the aim of this study was to compare the management and outcomes of hyperthyroid patients that were on ATDs prior to surgery to those who were not. STUDY DESIGN A prospectively maintained, single-institution database was queried for all hyperthyroid patients who were initially treated with ATDs and underwent thyroidectomy from January 1, 2012, to June 18, 2018. Patients were divided into two groups: (1) those on ATDs at surgery (ATD group) and (2) those who could not tolerate and stopped ATDs prior to surgery (no-ATD group). Demographic and clinical data were collected. Primary outcomes were readmissions/emergency department visits and postoperative complications within 30 days of thyroidectomy. RESULTS Of the 248 patients, 231 were in the ATD group and 17 (7%) were in the no-ATD group. There were no mortalities or thyroid storm events in either group. There was no difference in Clavien-Dindo Grade 2 or 3 complications between the two groups. There were no ED visits or 30-day readmissions in the no-ATD group compared to 17 (7%) events in the ATD group (p = 1.0). CONCLUSION While it is preferable to render patients euthyroid prior to thyroidectomy for hyperthyroidism, results of this study suggest that when patients cannot tolerate ATDs, it is possible to perform thyroidectomy without increased risk of thyroid storm or intra- and postoperative complications.",2020,There was no difference in Clavien-Dindo Grade 2 or 3 complications between the two groups.,"['hyperthyroid patients that were on ATDs prior to surgery to those who were not', 'patients euthyroid prior to thyroidectomy for hyperthyroidism', '248 patients', 'A prospectively maintained, single-institution database was queried for all hyperthyroid patients who were initially treated with ATDs and underwent thyroidectomy from January 1, 2012, to June 18, 2018']",[],"['Clavien-Dindo Grade 2 or 3 complications', 'ED visits or 30-day readmissions', 'readmissions/emergency department visits and postoperative complications within 30\xa0days of thyroidectomy', 'mortalities or thyroid storm events']","[{'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040125', 'cui_str': 'Antithyroid agent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0117002', 'cui_str': 'Euthyroid'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]",[],"[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040127', 'cui_str': 'Thyrotoxic crisis'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0243498,There was no difference in Clavien-Dindo Grade 2 or 3 complications between the two groups.,"[{'ForeName': 'Lily B', 'Initials': 'LB', 'LastName': 'Hsieh', 'Affiliation': 'Section of Endocrine Surgery, Division of Surgical Oncology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, USA.'}, {'ForeName': 'Tina W F', 'Initials': 'TWF', 'LastName': 'Yen', 'Affiliation': 'Section of Endocrine Surgery, Division of Surgical Oncology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, USA.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dream', 'Affiliation': 'Section of Endocrine Surgery, Division of Surgical Oncology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, USA.'}, {'ForeName': 'Dhaval', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Section of Endocrine Surgery, Division of Surgical Oncology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Evans', 'Affiliation': 'Section of Endocrine Surgery, Division of Surgical Oncology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, USA.'}, {'ForeName': 'Tracy S', 'Initials': 'TS', 'LastName': 'Wang', 'Affiliation': 'Section of Endocrine Surgery, Division of Surgical Oncology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, USA. tswang@mcw.edu.'}]",World journal of surgery,['10.1007/s00268-020-05654-4'] 2301,32572611,QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.,"BACKGROUND Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life. METHODS At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores. RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD - 3.1, 95% CI - 10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI - 5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI - 5.9 to 7.2). CONCLUSIONS Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.",2020,"RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery.",['after esophagectomy for cancer'],"['nutritional and respiratory counseling', 'nutritional counseling', 'QOLEC2', 'nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care']","['impairment in quality of life', 'Dyspnea', 'postoperative quality of life', 'mean score differences (MDs) in quality of life scores', 'appetite loss', 'Global quality of life']","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0621371,"RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery.","[{'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Pinto', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Nardi', 'Affiliation': 'Nutritional Support Unit, Veneto Institute of Oncology IOV-IRCCS, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Marchi', 'Affiliation': 'Respiratory Intensive Care Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Alfieri', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Saadeh', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cagol', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Baldan', 'Affiliation': 'Nutritional Support Unit, Veneto Institute of Oncology IOV-IRCCS, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Saraceni', 'Affiliation': 'Intensive Care Unit (ISTAR 2), Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Parotto', 'Affiliation': 'Intensive Care Unit, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Baratto', 'Affiliation': 'Intensive Care Unit (ISTAR 2), Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Caberlotto', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vianello', 'Affiliation': 'Respiratory Intensive Care Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Castoro', 'Affiliation': 'Department. of Upper GI Surgery, Humanitas Research Hospital-Humanitas University, Rozzano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scarpa', 'Affiliation': 'General Surgery Unit, Azienda Ospedaliera di Padova, Padua, Italy. marcoscarpa73@yahoo.it.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05573-z'] 2302,32572614,Piecewise regression equations for estimating stature: an anthropometric study in Spanish females.,"In forensic anthropology, generic equations are generally preferred for estimation of stature. However, recent studies have demonstrated that regression equations specific to stature groups yield more accurate predictions. Almost all previous studies have been conducted on male subjects, and it is not currently known how well such equations work for females. Therefore, this study aims to test whether regression equations specific to stature groups work for females as well. To this end, a cross-sectional study was conducted to estimate stature on a sample of 351 Spanish adult females. The participants were randomized into a calibration group (n = 185) and a validation group (n = 166). Equations for stature estimation based on tibial length were developed in the calibration group, which was categorized according to stature (short, medium, and tall) using the 15th and 85th percentiles as cut-off points. The standard errors of the estimations (SEEs) for the group-specific regression equations (SEE = 2.35-2.66 cm) were lower than for the general formula derived for all participants of the calibration group (SEE = 3.46 cm). The specific equations resulted in smaller differences between estimated and recorded statures than the generic equation when we tested the equations with the validation group. Additionally, the SEE values of the stature-specific equations are lower compared to generic equations applied to other human populations. In conclusion, the group-specific equations from tibial length have high accuracy compared with previously derived equations for Spanish females and other populations. This procedure for estimating stature thereby improves the tools available to forensic scientists.",2020,The specific equations resulted in smaller differences between estimated and recorded statures than the generic equation when we tested the equations with the validation group.,"['351 Spanish adult females', 'male subjects', 'Spanish females']",[],['tibial length'],"[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",351.0,0.0279549,The specific equations resulted in smaller differences between estimated and recorded statures than the generic equation when we tested the equations with the validation group.,"[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Saco-Ledo', 'Affiliation': 'Catalan School of Kinanthropometry, National Institute of Physical Education, University of Barcelona, Barcelona, Spain. gonzalo.saco@cenieh.es.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Porta', 'Affiliation': 'Catalan School of Kinanthropometry, National Institute of Physical Education, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Tesla A', 'Initials': 'TA', 'LastName': 'Monson', 'Affiliation': 'Department of Anthropology, Western Washington University, Bellingham, WA, USA.'}, {'ForeName': 'Marianne F', 'Initials': 'MF', 'LastName': 'Brasil', 'Affiliation': 'Human Evolution Research Center, University of California Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Atamtürk', 'Affiliation': 'Department of Anthropology, Faculty of Letters, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Izzet', 'Initials': 'I', 'LastName': 'Duyar', 'Affiliation': 'Department of Anthropology, Faculty of Letters, Istanbul University, Istanbul, Turkey.'}]",International journal of legal medicine,['10.1007/s00414-020-02350-9'] 2303,32572617,Whey protein consumption following fasted exercise reduces early postprandial glycaemia in centrally obese males: a randomised controlled trial.,"PURPOSE Acute submaximal exercise and whey protein supplementation have been reported to improve postprandial metabolic and appetite responses to a subsequent meal independently. We aimed to examine the combination of these strategies on postprandial responses to a carbohydrate-rich breakfast. METHODS Twelve centrally obese males (age 41 ± 3 years, waist circumference 123.4 ± 2.9 cm), completed three trials in a single-blind, crossover design. Participants rested for 30 min (CON) or completed 30 min low-moderate-intensity treadmill walking (51 ± 1% [Formula: see text]) followed immediately by ingestion of 20 g whey protein (EX + PRO) or placebo (EX). After 15 min, a standardised breakfast was consumed and blood, expired gas and subjective appetite were sampled postprandially. After 240 min, an ad libitum lunch meal was provided to assess energy intake. RESULTS During EX + PRO, post-breakfast peak blood glucose was reduced when compared with EX and CON (EX + PRO: 7.6 ± 0.4 vs EX: 8.4 ± 0.3; CON: 8.3 ± 0.3 mmol l -1 , p ≤ 0.04). Early postprandial glucose AUC 0-60 min was significantly lower under EX + PRO than EX (p = 0.011), but not CON (p = 0.12). Over the full postprandial period, AUC 0-240 min during EX + PRO did not differ from other trials (p > 0.05). Peak plasma insulin concentrations and AUC 0-240 min were higher during EX + PRO than CON, but similar to EX. Plasma triglyceride concentrations, substrate oxidation and subjective appetite responses were similar across trials and ad libitum energy intake was not influenced by prior fasted exercise, nor its combination with whey protein supplementation (p > 0.05). CONCLUSION Following fasted low-moderate-intensity exercise, consuming whey protein before breakfast may improve postprandial glucose excursions, without influencing appetite or subsequent energy intake, in centrally obese males. TRIAL REGISTRATION NUMBER NCT02714309.",2020,"Peak plasma insulin concentrations and AUC 0-240 min were higher during EX + PRO than CON, but similar to EX.","['years, waist circumference 123.4\u2009±\u20092.9\xa0cm', 'centrally obese males', 'Twelve centrally obese males (age 41\u2009±\u20093']","['Whey protein consumption following fasted exercise', '30\xa0min (CON) or completed 30\xa0min low-moderate-intensity treadmill walking (51\u2009±\u20091% [Formula: see text]) followed immediately by ingestion of 20\xa0g whey protein (EX\u2009+\u2009PRO) or placebo (EX', 'Acute submaximal exercise and whey protein supplementation', 'fasted low-moderate-intensity exercise, consuming whey protein before breakfast']","['Peak plasma insulin concentrations and AUC 0-240\xa0min', 'Plasma triglyceride concentrations, substrate oxidation and subjective appetite responses', 'breakfast peak blood glucose', 'early postprandial glycaemia', 'postprandial glucose excursions', 'postprandial metabolic and appetite responses', 'blood, expired gas and subjective appetite']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1549040', 'cui_str': 'Before breakfast'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017110', 'cui_str': 'Gas'}]",12.0,0.100132,"Peak plasma insulin concentrations and AUC 0-240 min were higher during EX + PRO than CON, but similar to EX.","[{'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Allerton', 'Affiliation': 'School of Biomedical, Nutritional and Sport Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'West', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Stevenson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK. emma.stevenson@newcastle.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-020-02304-2'] 2304,32572628,Efficacy comparison of laparoscopic sleeve gastrectomy in type 2 diabetes patients with a BMI 30-34.9 kg/m 2 versus BMI < 30 kg/m 2 .,"BACKGROUND Laparoscopic sleeve gastrectomy (LSG) is safe and effective in type 2 diabetes mellitus (T2DM) with body mass index (BMI) ≥ 35 kg/m 2 . However, the effect and safety of LSG in the treatment of T2DM patients with BMI less than 35 kg/m 2 , especially in patients with BMI less than 30 kg/m 2 , are still debatable. METHODS A total of 51 T2DM patients with BMI less than 35 kg/m 2 treated successfully with LSG were included in our study. All patients were divided into two groups for subgroup analysis, namely group A (BMI 23.23-29.97 kg/m 2 ) and group B (BMI 30.0-34.9 kg/m 2 ). The weight loss and diabetic characteristics of LSG in the two groups at 3 months, 6 months, and 12 months after operation were compared, respectively. RESULTS In group A, the complete remission rates of T2DM were 20%, 36%, and 44% at 3, 6, and 12 months after operation, respectively. In group B, the complete remission rates of T2DM were 30.8%, 61.5%, and 88.5% at 3, 6, and 12 months after operation, respectively. Besides, none of the patients with a duration more than 15 years achieved complete remission. For T2DM patients with BMI < 30 kg/m 2 at 12 months after LSG, the complete remission rate of T2DM was 15.4% in patients with ABCD scores ≤ 2, and the complete remission rate of T2DM was 100% in patients with ABCD scores ≥ 5. CONCLUSION LSG is safe and effective for T2DM patients with BMI less than 35 kg/m 2 in the short-term. However, the complete remission rate of T2DM in patients with BMI less than 30 kg/m 2 is far from the diabetes patients with BMI at 30-34.9 kg/m 2 .",2020,"In group B, the complete remission rates of T2DM were 30.8%, 61.5%, and 88.5% at 3, 6, and 12 months after operation, respectively.","['type 2 diabetes mellitus (T2DM) with body mass index (BMI)\u2009≥\u200935\xa0kg', 'type 2 diabetes patients with a BMI 30-34.9\xa0kg/m 2 versus BMI\u2009<\u200930\xa0kg/m 2 ', '51 T2DM patients with BMI less than 35\xa0kg/m 2 treated successfully with']","['Laparoscopic sleeve gastrectomy (LSG', 'laparoscopic sleeve gastrectomy', 'LSG']","['weight loss and diabetic characteristics of LSG', 'complete remission rate of T2DM', 'complete remission', 'complete remission rates of T2DM']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",51.0,0.0210851,"In group B, the complete remission rates of T2DM were 30.8%, 61.5%, and 88.5% at 3, 6, and 12 months after operation, respectively.","[{'ForeName': 'Diqing', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, China-Japan Union Hospital, Jilin University, No. 126 Xiantai Avenue, Changchun City, 130033, Jilin Province, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, China-Japan Union Hospital, Jilin University, No. 126 Xiantai Avenue, Changchun City, 130033, Jilin Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Bariatric and Metabolic Surgery, China-Japan Union Hospital, Jilin University, No. 126 Xiantai Avenue, Changchun City, 130033, Jilin Province, China. jiangtao1099899@163.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07749-4'] 2305,32572652,Ticagrelor Versus Clopidogrel in Patients with Late or Very Late Stent Thrombosis.,"PURPOSE To compare the effect of ticagrelor with clopidogrel in reducing the risk of ischemic cardiovascular events in patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI). METHODS A total of 4538 patients with acute coronary syndrome were screened for angiographically determined LST/VLST. Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n = 81) or clopidogrel (n = 160) at discharge. The clinical outcome was major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period. RESULTS After propensity score matching, 65 pairs were generated. The incidence of MACE was significantly lower in the ticagrelor group compared with the clopidogrel group (9.3% vs. 21.5%, log-rank p = 0.048). However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group. CONCLUSION Following successful primary PCI, patients with LST/VLST who received ticagrelor had fewer ischemic cardiovascular events at 1-yr follow-up, compared with those who received clopidogrel.",2020,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group. ","['patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI', 'n\u2009=\u2009160) at discharge', 'Patients with Late or Very Late Stent Thrombosis', 'Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n\u2009=\u200981) or', '4538 patients with acute coronary syndrome']","['ticagrelor with clopidogrel', 'Ticagrelor Versus Clopidogrel', 'clopidogrel', 'ticagrelor']","['incidence of MACE', 'event rates of death, MI, ischemic stroke, and revascularization', 'ischemic cardiovascular events', 'major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",4538.0,0.0802211,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group. ","[{'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Sheng', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Runzhen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. hbyanfuwai2018@163.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07021-w'] 2306,32572683,Effects of a forehead cooling device in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions: a pilot study.,"PURPOSE While forehead cooling has been studied in patients with insomnia in the absence of comorbid medical/psychiatric disorders, it has never been evaluated in patients with insomnia in the presence of co-morbid medical/psychiatric disorders. METHODS Veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions received 4-week open-label, in-home, nightly treatment with a forehead cooling device (14-16 °C) along with personalized sleep hygiene following baseline assessments. Pre- and post-treatment, participants completed the Insomnia Severity Index (ISI), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Patient Health Questionnaire 9-item scale (PHQ-9). Participants recorded daily sleep and anxiety/arousal symptoms. RESULTS Of 24 veterans (20 men, 42.2 ± 9.5 years), 17 (71%) had marked insomnia severity improvement (a decrease of > 8 on the ISI) and 10 (42%) participants scored 7 or below on the ISI at post-treatment reflecting remission. Participants reported reductions in sleep onset latency (SOL) (F = 12.9, p < 0.001), and wakefulness after sleep onset (WASO) (F = 8.4, p < 0.001) across treatment. They also had significant reductions in insomnia severity (t = 10.04, p < 0.001), anxiety (t = 3.59, p = 0.002), and depression (t = 7.75, p < 0.001) from pre- to post-treatment. CONCLUSION This pilot study shows that 4-week nightly use of a forehead cooling device produces improvements in insomnia, anxiety, and depressive symptoms in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions. Controlled studies are warranted to determine the role of this therapy in the management of insomnia in veterans. TRIAL REGISTRATION Not required as a small sample size feasibility study.",2020,"Participants reported reductions in sleep onset latency (SOL) (F = 12.9, p < 0.001), and wakefulness after sleep onset (WASO) (F = 8.4, p < 0.001) across treatment.","['insomnia in veterans', 'Of 24 veterans (20 men, 42.2 ± 9.5 years', 'Veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions received', 'veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions', 'patients with insomnia in the absence of comorbid medical/psychiatric disorders']","['4-week open-label, in-home, nightly treatment with a forehead cooling device', 'forehead cooling device', 'Pre- and post-treatment']","['marked insomnia severity improvement', 'insomnia severity', 'anxiety', 'sleep onset latency (SOL', 'wakefulness after sleep onset (WASO', 'insomnia, anxiety, and depressive symptoms', 'Insomnia Severity Index (ISI), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Patient Health Questionnaire 9-item scale (PHQ-9', 'daily sleep and anxiety/arousal symptoms', 'depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0435618,"Participants reported reductions in sleep onset latency (SOL) (F = 12.9, p < 0.001), and wakefulness after sleep onset (WASO) (F = 8.4, p < 0.001) across treatment.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mysliwiec', 'Affiliation': 'UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Chiappetta', 'Affiliation': 'DataDIVA, LLC, Pittsburgh, PA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Nofzinger', 'Affiliation': 'Ebb Therapeutics, 2555 Smallman Street Suite 100, Pittsburgh, PA, 15222, USA. enofzinger@ebbsleep.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02126-w'] 2307,32572711,Examining Correlates of Pre-ART and Early ART Adherence to Identify Key Factors Influencing Adherence Readiness.,"Although current standard of care for HIV typically involves immediate initiation of antiretroviral therapy (ART), most patients can benefit from first assessing adherence readiness and addressing any barriers to optimal adherence. A sample of 176 HIV patients planning to start ART enrolled in a controlled trial of an adherence intervention that was based on the Information Motivation and Behavioral skills (IMB) model of health behavior. We examined correlates of multiple adherence readiness measures, as well as electronically measured early ART adherence, to identify variables most important for readiness to adhere well at the start of treatment. Education level, recency of HIV diagnosis and knowledge and commitment to adherence were found to be associated with both ART readiness and early ART adherence. These findings suggest that resources to support adherence readiness should target more experienced HIV patients, and strive to bolster knowledge and attitudes that reinforce commitment to adherence.",2020,"Education level, recency of HIV diagnosis and knowledge and commitment to adherence were found to be associated with both ART readiness and early ART adherence.",['176 HIV patients planning to start ART enrolled in a controlled trial of an'],"['Pre-ART and Early ART', 'adherence intervention']","['ART readiness and early ART adherence', 'Information Motivation and Behavioral skills (IMB) model of health behavior', 'Education level, recency of HIV diagnosis and knowledge and commitment to adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}]",176.0,0.0323265,"Education level, recency of HIV diagnosis and knowledge and commitment to adherence were found to be associated with both ART readiness and early ART adherence.","[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Gordon', 'Affiliation': 'Department of Medicine, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Department of Medicine, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Gulrez', 'Initials': 'G', 'LastName': 'Azhar', 'Affiliation': 'Long Beach Education and Research Consultants, Long Beach, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramirez', 'Affiliation': 'Social and Economic Wellbeing Division, RAND Corporation, 1776 Main St., Santa Monica, CA, 90401, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Social and Economic Wellbeing Division, RAND Corporation, 1776 Main St., Santa Monica, CA, 90401, USA.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Wagner', 'Affiliation': 'Long Beach Education and Research Consultants, Long Beach, CA, USA. gwagner@rand.org.'}]",AIDS and behavior,['10.1007/s10461-020-02947-6'] 2308,32572776,"Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet () and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial.","BACKGROUND Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B (CHB), but it has a limited effect on cirrhosis. Chinese medicines (CMs), particularly Fuzheng Huayu Tablet (, FZHY), have an antifibrotic effect in patients with CHB. OBJECTIVE To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus (HBV) cirrhosis, this study was designed as a randomized, placebo-controlled, double-blind, parallel assignment, multicenter trial at 20 centers in China. The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV, and randomly assigned into 2 groups, receiving entecavir (0.5 mg, daily) and FZHY placebo (1.6 g, 3 times a day), or entecavir (0.5 mg, daily) and FZHY (1.6 g, 3 times a day), respectively. The primary endpoint was histological improvement at week 48. The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study. Adverse events such as stomach upset, headache, fatigue, dizziness, nausea will be strictly recorded. DISCUSSION Through this study, we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY. Protocol version: Version 1.3, Date: 2014.12.4. TRIAL REGISTRATION NUMBER NCT02241590.",2020,"Chinese medicines (CMs), particularly Fuzheng Huayu Tablet (, FZHY), have an antifibrotic effect in patients with CHB. ","['patients with hepatitis B virus (HBV) cirrhosis', 'patients with CHB', 'The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV', '20 centers in China']","['adjunctive FZHY', 'entecavir', 'Fuzheng Huayu Tablet () and Entecavir', 'Chinese medicines (CMs), particularly Fuzheng Huayu Tablet (, FZHY', 'FZHY placebo', 'placebo']","['safety and efficacy', 'histological improvement', 'Adverse events such as stomach upset, headache, fatigue, dizziness, nausea', 'decline values of liver fibrosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C2607355', 'cui_str': 'fuzheng huayu'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235309', 'cui_str': 'Upset stomach'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",700.0,0.706442,"Chinese medicines (CMs), particularly Fuzheng Huayu Tablet (, FZHY), have an antifibrotic effect in patients with CHB. ","[{'ForeName': 'Zheng-Xin', 'Initials': 'ZX', 'LastName': 'Li', 'Affiliation': 'Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Zhao', 'Affiliation': 'Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Qing-Shan', 'Initials': 'QS', 'LastName': 'Zheng', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 200000, China.'}, {'ForeName': 'Cheng-Hai', 'Initials': 'CH', 'LastName': 'Liu', 'Affiliation': 'Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. chenghai.liu@outlook.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3257-6'] 2309,32572777,Protective Effects of Salvianolate on Myocardial Injury or Myocardial Infarction after Elective Percutaneous Coronary Intervention in NSTE-ACS Patients: A Randomized Placebo-Controlled Trial.,"OBJECTIVE To evaluate the protective effects of salvianolate on percutaneous coronary intervention (PCI) related myocardial injury or myocardial infarction after elective PCI in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients. METHODS A total of 149 patients with NSTE-ACS who underwent elective PCI were enrolled. The patients were randomly allocated in a 1:1 ratio to the salvianolate group (74 cases) or the control group (75 cases). After exclusion criteria of coronary angiography, 60 patients with PCI therapy remained in the salvianolate group and 68 in the control group. The incidence and the severity of PCI related myocardial injury or myocardial infarction, in addition to major adverse cardiac events (MACEs) during 1 year follow-up after PCI were studied between the two groups. Multivariate logistic regression analysis was used to determine the independent factors for PCI related myocardial injury or myocardial infarction after elective PCI. RESULTS Compared with the control group, salvianolate treatment reduced the incidence of PCI related severe myocardial injury or myocardial infarction (11.7% vs. 26.5%, P=0.035). The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups. CONCLUSIONS Periprocedural treatment with salvianolate reduces the incidence of PCI related severe myocardial injury or myocardial infarction, although it does not influence clinical prognosis. [Chinese clinical trial registry: ChiCTR1800016992].",2020,"The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups. ","['non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients', '149 patients with NSTE-ACS who underwent elective PCI were enrolled', 'Myocardial Injury or Myocardial Infarction after Elective Percutaneous Coronary Intervention in NSTE-ACS Patients', '60 patients with PCI therapy remained in the salvianolate group and 68 in the control group']","['percutaneous coronary intervention (PCI', 'Salvianolate', 'salvianolate', 'Placebo']","['severity of PCI related myocardial injury or myocardial infarction, in addition to major adverse cardiac events (MACEs', 'incidence of PCI related severe myocardial injury or myocardial infarction', 'rate of MACEs or all-cause death']","[{'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3252125', 'cui_str': 'salvianolate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C3252125', 'cui_str': 'salvianolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",149.0,0.0886597,"The rate of MACEs or all-cause death within 1 month or 1 year after the procedure was not significantly different between the two groups. ","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ou', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Sheng-Jia', 'Initials': 'SJ', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Hai-Ming', 'Initials': 'HM', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Luo', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Xin-Ping', 'Initials': 'XP', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Yun-Zhi', 'Initials': 'YZ', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Yu-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China.'}, {'ForeName': 'Hong-Ying', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Medical Department, Shanghai Green Valley Pharmaceutical Co., Ltd., Shanghai, 201203, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Huashan Hospital, Fudan University, Shanghai, 200040, China. drshenwei@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-2728-0'] 2310,32572778,"Essential Oil from Citrus aurantium Alleviates Anxiety of Patients Undergoing Coronary Angiography: A Single-Blind, Randomized Controlled Trial.","OBJECTIVE To determine the effectiveness and safety of essential oil from Citrus aurantium on anxiety in patients undergoing coronary angiography. METHODS A single-blind, randomized controlled trial was conducted in 80 patients experiencing coronary angiography in Imam Ali Hospital in Kermanshah, Iran from April to November in 2016. All patients were randomly divided into intervention and control groups by a random number table, 40 cases in each group. The patients in the intervention group inhaled Citrus aurantium essential oil for 15-20 min about 60 min before angiography. Following the same procedure, distilled water was used instead of Citrus aurantium in the control group. Spielbergers State-Trait Anxiety Inventory (STAI) was filled in and vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory and pulse rate were recorded before and 20 min after the intervention. Adverse reactions after intervention were observed. RESULTS In the intervention group, the mean scores of STAI, SBP, DBP, respiratory and pulse rate were 53.30 ± 10.13, 134.82 ± 11.75 mm Hg, 84.49 ± 6.99 mm Hg, 17.87 ± 1.73 times/min, and 76.48 ± 12.55 beats/min at baseline and significantly decreased to 42.37 ± 10.15, 124.49 ± 10.48 mm Hg, 79.23 ± 6.62 mm Hg, 14.54 ± 1.43 times/min, and 70.03 ± 13.66 beats/min respectively 20 min after intervention (all P<0.05); however, in the control group, neither anxiety scores nor vital signs changed significantly (P>0.05). All subjects reported no adverse reactions. CONCLUSION Inhalation of the essential oil from Citrus aurantium was effective in reducing anxiety and stress levels in patients undergoing coronary angiography. TRIAL REGISTRATION IRCT2016040816797N2 (retrospectively registered on 21 April 2016, https://en.irct.ir/trial/15600).",2020,"Inhalation of the essential oil from Citrus aurantium was effective in reducing anxiety and stress levels in patients undergoing coronary angiography. ","['patients undergoing coronary angiography', 'Patients Undergoing Coronary Angiography', '80 patients experiencing coronary angiography in Imam Ali Hospital in Kermanshah, Iran from April to November in 2016']","['essential oil from Citrus aurantium', 'intervention group inhaled Citrus aurantium essential oil']","['systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory and pulse rate', 'Spielbergers State-Trait Anxiety Inventory (STAI', 'anxiety and stress levels', 'anxiety scores nor vital signs', 'Adverse reactions', 'mean scores of STAI, SBP, DBP, respiratory and pulse rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0330922', 'cui_str': 'Citrus aurantium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",80.0,0.0549123,"Inhalation of the essential oil from Citrus aurantium was effective in reducing anxiety and stress levels in patients undergoing coronary angiography. ","[{'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': 'Intensive Care Unit, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ashtarian', 'Affiliation': 'Health Education Department, Health School, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nicholas Yakubu', 'Initials': 'NY', 'LastName': 'Danzima', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Saeedi', 'Affiliation': 'Student Research Committee, School of Nursing, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Bijan', 'Affiliation': 'Intensive Care Unit, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Akbari', 'Affiliation': 'Intensive Care Unit, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Mohammadi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. mehdi20.mohamadi@gmail.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3266-5'] 2311,32572795,Study protocol of a randomized intervention study to explore effects of a pure physical training and a mind-body exercise on cognitive executive function in independent living adults age 65-85.,"BACKGROUND Decline in cognitive function associated with aging is one of the greatest concerns of older adults and often leads to a significant burden for individuals, families, and the health care system. Executive functions are most susceptible to age-related decline. Despite the well-known benefits of regular exercise on cognitive health, older adults tend to be less physically active than other age groups. Thus, there is a need to identify strategies that attract older adults and can enhance cognitive vitality. AIMS This article describes the protocol of a study designed to evaluate whether two interventions, a pure physical exercise and a mind-body exercise, can improve cognitive executive function in independent-living older adults. In addition, the study will explore barriers/facilitators related to adherence. METHODS After baseline assessment, participants will be randomly assigned to one of three groups (strength training, Awareness Through Movement ® , or a control group). Participants of the two active groups will attend the interventions for 12 weeks. The control group continues with the usual everyday life. Assessments will include three measures of executive function of the NIH Toolbox, and are administered at baseline, post-intervention and at 3-month follow-up. The primary outcomes are the changes in cognitive executive function performances. Secondary outcomes include adherence, self-efficacy for exercise, symptoms of depression, mindfulness and enjoyment. Attendance will be used as a measure of adherence. DISCUSSION AND CONCLUSION If successful, the interventions could provide low-cost strategies for older adults to maintain cognitive vitality and has the potential to impact current exercise guidelines.",2020,"Despite the well-known benefits of regular exercise on cognitive health, older adults tend to be less physically active than other age groups.","['independent living adults age 65-85', 'attract older adults', 'older adults', 'independent-living older adults']","['regular exercise', 'pure physical exercise and a mind-body exercise', 'pure physical training and a mind-body exercise']","['Executive functions', 'changes in cognitive executive function performances', 'adherence, self-efficacy for exercise, symptoms of depression, mindfulness and enjoyment', 'cognitive executive function']","[{'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",,0.0376796,"Despite the well-known benefits of regular exercise on cognitive health, older adults tend to be less physically active than other age groups.","[{'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Ullmann', 'Affiliation': 'Social and Behavioral Sciences, School of Public Health, University of Memphis, Memphis, TN, USA. ullmann1@memphis.edu.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Exercise, Sport and Movement Sciences, School of Health Studies, University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Ray', 'Affiliation': 'Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Shirleatha T', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Mary Black School of Nursing, University of South Carolina Upstate, Spartanburg, SC, USA.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01633-w'] 2312,32576901,An optimized test bolus for computed tomography pulmonary angiography and its application at 80 kV with 10 ml contrast agent.,"Computed tomography pulmonary angiography (CTPA) is usually used for pulmonary embolism (PE) detection. However, the determination of scan timing remains a challenge due to the short scan duration of CTPA. We aimed to develop an optimized test bolus to determine scan delay in CTPA. The time-enhancement curves were obtained by measuring the enhancement within a region of interest in the main pulmonary artery and vein. A total of 70 patients were randomly divided into two groups (n = 35 each): the control group underwent CTPA using the test bolus approach and the test group underwent CTPA using the biphasic time-enhancement curves approach. Tube voltages of 100 kVp and 80 kVp and 20 ml and 10 ml contrast agent were adopted in the control and test groups, respectively. The CT numbers, image quality, PE detection was evaluated. There was a point of intersection between the pulmonary artery and vein test bolus enhancement curves. The scan delay time (T DELAY ) was obtained based on the time at intersection (T CROSS ) and the scan duration (T SD ): T DELAY  = T CROSS - T SD . The mean CT numbers for pulmonary vein in the control were higher than those in the test group (all p < 0.001). The image quality for the pulmonary arteries in the test group was better than that in the control group (p < 0.01), with artifact reduction in the superior vena cava. Segmental PE could be detected using the optimized protocol. The radiation dose and iodine load in the test group were all lower than those in the control (p < 0.01). We established an approach to calculate the scan delay of CTPA, and this approach could be used for CTPA at 80 kVp with 10 ml contrast agent.",2020,"The image quality for the pulmonary arteries in the test group was better than that in the control group (p < 0.01), with artifact reduction in the superior vena cava.",['A total of 70 patients'],"['control group underwent CTPA', 'Tube voltages of 100 kVp and 80 kVp and 20', 'Computed tomography pulmonary angiography (CTPA', 'CTPA']","['image quality for the pulmonary arteries', 'mean CT numbers for pulmonary vein', 'time-enhancement curves', 'radiation dose and iodine load', 'CT numbers, image quality, PE detection', 'scan delay time (T DELAY ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}]",70.0,0.0231022,"The image quality for the pulmonary arteries in the test group was better than that in the control group (p < 0.01), with artifact reduction in the superior vena cava.","[{'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Qin', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Zhaochun', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Zhongqiu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China. zhqwang001@126.com.'}]",Scientific reports,['10.1038/s41598-020-67145-9'] 2313,32577026,A Randomized Phase 2 Trial of Antibiotic Prophylaxis Versus No Intervention for Muscle Biopsy in A Neurology Department.,"Muscle biopsy can be used to confirm the diagnosis of neuromuscular diseases. However, it is unclear whether antibiotic prophylaxis prior to muscle biopsy is needed to prevent surgical site infection (SSI). We are conducting a phase 2, single-center, open-labeled, prospective randomized trial to clarify the need for antibiotic prophylaxis in patients at low risk for SSI undergoing muscle biopsy. Patients will be randomized to an antibiotic prophylaxis group or a control group, and the incidence of SSI will be compared between the groups. Our findings will clarify the need for antibiotic prophylaxis in this patient population.",2020,"Patients will be randomized to an antibiotic prophylaxis group or a control group, and the incidence of SSI will be compared between the groups.",['patients at low risk for SSI undergoing muscle biopsy'],"['Antibiotic Prophylaxis', 'antibiotic prophylaxis']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]",[],,0.055273,"Patients will be randomized to an antibiotic prophylaxis group or a control group, and the incidence of SSI will be compared between the groups.","[{'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Nakahara', 'Affiliation': 'Department of Neurology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Tokunori', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Takamatsu', 'Affiliation': 'Department of Neurology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Tawara', 'Affiliation': 'Department of Neurology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Neurology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Enokida', 'Affiliation': 'Department of Pharmacy, Kumamoto University Hospital, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Tanoue', 'Affiliation': 'Department of Pharmacy, Kumamoto University Hospital, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Sawana', 'Initials': 'S', 'LastName': 'Narita', 'Affiliation': 'Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Fujii', 'Affiliation': 'Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Yamanouchi', 'Affiliation': 'Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Morinaga', 'Affiliation': 'Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto 860-8556, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Department of Neurology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 860-8556, Japan.'}]",Acta medica Okayama,['10.18926/AMO/59961'] 2314,32577113,Automated Mobile Phone Messaging Utilizing a Cognitive Behavioral Intervention: A Pilot Investigation.,"Background In the setting of outpatient orthopaedic surgery, this pilot study utilized automated mobile messaging to assess (1) the feasibility of and interaction rates with a software delivered cognitive behavior therapy (CBT) intervention for postoperative opioid utilization, (2) the reliability of patient reported opioid utilization through our platform, (3) daily patient reported pain and opioid utilization within the first two postoperative weeks, and (4) the effect of software delivered CBT intervention on patient reported opioid utilization. Methods Musculoskeletal tumor patients scheduled for outpatient surgery were randomized into two study groups. Control patients received standard postoperative communication limited to a two-week postoperative follow-up visit. The intervention group received automated daily text-messages regarding pain, opioid utilization, and a daily CBT intervention. Interventional group patients also completed a patient satisfaction questionnaire at their two-week follow-up. Completion rates of all software delivered questions were determined in the interventional group. Median values of opioid utilization and interquartile range (IQR) were determined to compare utilization between groups. Spearman correlation coefficients were used to determine reliability of patient reported opioid utilization in the interventional group. Results Fourteen patients completed the pilot study (seven controls, seven intervention). Patients in the intervention arm completed 90% of pain and opioid questions. Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%). Correlation between in-office pill counts and patient reported opioid medication utilization via our software messaging system was high (r=0.90, p=0.037). Conclusion Automated mobile phone messaging in outpatient tumor surgery yielded high interaction rates. Patient reported opioid utilization obtained through our platform demonstrated a high correlation with in-office pill counts. CBT delivered via automated mobile phone messaging demonstrated decreased opioid utilization in this pilot investigation. Level of evidence: II .",2019,"Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%).",['Methods\n\n\nMusculoskeletal tumor patients scheduled for outpatient surgery'],"['CBT delivered via automated mobile phone messaging', 'Automated Mobile Phone Messaging Utilizing a Cognitive Behavioral Intervention', 'automated daily text-messages regarding pain, opioid utilization, and a daily CBT intervention', 'CBT intervention', 'cognitive behavior therapy (CBT) intervention']","['opioid utilization', 'pain and opioid utilization', 'Median values of opioid utilization and interquartile range (IQR', 'daily prescribed opioid medication', 'opioid medication utilization', 'patient satisfaction questionnaire']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0693844,"Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%).","[{'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'Rojas', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kain', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Apurva S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Division of Orthopaedics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Miller', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}]",The Iowa orthopaedic journal,[] 2315,32577117,A mushroom diet reduced the risk of pregnancy-induced hypertension and macrosomia: a randomized clinical trial.,"Background Pregnancy-induced hypertension (PIH) is a disease characterized by high blood pressure detected after 20 weeks of pregnancy, affecting approximately 10% of pregnant women worldwide. Effective strategies are imperatively needed to prevent and treat PIH. Methods Subjects were required to consume 100 g mushroom daily from pre-pregnancy to the 20th week of gestation. The gestational hypertension and related primary and secondary outcomes of the mushroom diet (MD) group and placebo group were investigated to compare the intervention of a MD on the PIH and preeclampsia-associated maternal and child health conditions. Results A total of 582 and 580 subjects belonging to the MD group and placebo group were included for the analysis, respectively. Compared to the placebo, the MD significantly reduced the incidence of gestational hypertension ( P = 0.023), preeclampsia ( P = 0.014), gestational weight gain ( P = 0.017), excessive gestational weight gain ( P = 0.032) and gestational diabetes ( P = 0.047). Stratified analysis showed that the MD lowered the risk of PIH for overweighed women ( P = 0.036), along with the percentage of macrosomia ( P = 0.007). Conclusion An MD could serve as a preventative strategy for lowering the risk of PIH and could control newborn birthweight while reducing comorbidities including gestational weight gain, diabetes etc.",2020,"Compared to the placebo, the MD significantly reduced the incidence of gestational hypertension ( P = 0.023), preeclampsia ( P = 0.014), gestational weight gain ( P = 0.017), excessive gestational weight gain ( P = 0.032) and gestational diabetes ( P = 0.047).",['A total of 582 and 580 subjects belonging to the MD group and'],"['mushroom diet', '\n\n\nPregnancy-induced hypertension (PIH', 'mushroom diet (MD) group and placebo', 'placebo']","['gestational diabetes', 'incidence of gestational hypertension', 'risk of pregnancy-induced hypertension and macrosomia', 'PIH and preeclampsia-associated maternal and child health conditions', 'gestational weight gain', 'risk of PIH', 'excessive gestational weight gain', 'preeclampsia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0001774', 'cui_str': 'Order Agaricales'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001774', 'cui_str': 'Order Agaricales'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0852036', 'cui_str': 'Pregnancy-induced hypertension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0404588', 'cui_str': 'Finding related to risk factor in pregnancy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0852036', 'cui_str': 'Pregnancy-induced hypertension'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}]",582.0,0.197371,"Compared to the placebo, the MD significantly reduced the incidence of gestational hypertension ( P = 0.023), preeclampsia ( P = 0.014), gestational weight gain ( P = 0.017), excessive gestational weight gain ( P = 0.032) and gestational diabetes ( P = 0.047).","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Obstertrics, Liaocheng People Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Zhanjie', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of Obstertrics, Liaocheng People Hospital, Liaocheng, Shandong, China.'}]",Food & nutrition research,['10.29219/fnr.v64.4451'] 2316,32573284,Participant expectations and experiences of a tailored physiotherapy intervention for people with Parkinson's and a history of falls.,"Purpose: People with Parkinson's are twice as likely to fall as older people within the general population. This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention. Specific qualitative aims focused on a subsample of trial participants in the intervention arm of the trial, and comprised the following:To explore the expectations of participants about the intervention.To investigate participants' experiences of the intervention, and its perceived impacts.To understand the facilitators and barriers to engagement. Methods: Two semi-structured interviews were completed with a theoretical sample of people with Parkinson's from the intervention arm, initially after randomisation but before the intervention commenced, and then again six months later. Results: Forty-two participants out of a large clinical trial were interviewed initially, with 37 agreeing to a second interview at six months. Prior experience of rehabilitation plus information accessed through the trial consent procedure informed participants' realistic expectations. Most found the level of the intervention acceptable, and perceived a range of benefits. However, views about equipment provided were more equivocal. The biggest barriers to participation were time and motivation, whilst social support facilitated engagement with the intervention. Conclusions: This study is the first to capture expectations about participation in a programme of exercises and strategies. It highlights that previous challenges to engagement in physical exercises and activities are not a barrier to future participation and provides new insights into the role of equipment and technology in programmes of physical activity for people with Parkinson's. The challenge of ensuring that programmes of exercise and strategies become an embedded feature of everyday life is highlighted, particularly alongside busy social engagements and leisure pursuits.Implications for rehabilitationFor people with Parkinsons, a programme of exercises and strategies has the potential to reduce the risk of falls amongst those with a history of falling.Adherence to such programmes can prove challenging for a variety of reasons, even when participants have realistic expectations about the commitment and effort needed.Clear explanations about the role of equipment and technology within such programmes could enhance adherence.In order to further individualise programmes of exercise for people with Parkinsons, choice regarding social support, reminders and integration into everyday activities should be explored.",2020,This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention.,"['older people within the general population', 'rehabilitationFor people with Parkinsons', ""people with Parkinson's"", ""people with Parkinson's and a history of falls"", 'Results: Forty-two participants out of a large clinical trial were interviewed initially, with 37 agreeing to a second interview at six months']",['tailored physiotherapy intervention'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],42.0,0.0346235,This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention.,"[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rowsell', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashburn', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fitton', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Goodwin', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Hulbert', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Institute for Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'Rehabilitation Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pickering', 'Affiliation': 'Biomedical Research Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Translational and Clinical Research Institute, University of Newcastle, Newcastle, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Chivers-Seymour', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ballinger', 'Affiliation': 'Biomedical Research Centre, University of Southampton, Southampton, UK.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1779824'] 2317,32573365,Evaluation of an Adapted Collaborative Care Model for Older Adult Depression Severity Reduction and Quality of Life Improvement.,"PURPOSE The purpose of this clinical study was to evaluate the efficacy of a collaborative care model in the reduction of depression severity and the improvement of quality of life (QOL) of older adults. METHODS Individual participant encounters were conducted approximately every 2 weeks over 4 months with nineteen participants. Average participant age was 73 years. A pre-experimental single pretest-posttest group was conducted in which the Patient Health Questionnaire 9 (PHQ-9) and Quality of Life Assessment (QOLA) scores respectively measured depression severity and QOL of participants. RESULTS The average PHQ-9 score (0-27; higher indicates worse depression) decreased from 14 pre-intervention to 8.3 post-intervention ( p < .001), while the average QOLA score (0-10; higher indicates better QOL) increased from 5.7 pre-intervention to 6.5 post-intervention ( p = .342). CONCLUSION The adapted collaborative care model provided an affordable, effective method of older adult depression management within the contexts of this clinical study.",2020,"The adapted collaborative care model provided an affordable, effective method of older adult depression management within the contexts of this clinical study.","['Individual participant encounters were conducted approximately every 2\xa0weeks over 4\xa0months with nineteen participants', 'older adults', 'Average participant age was 73\xa0years']",['collaborative care model'],"['Older Adult Depression Severity Reduction and Quality of Life Improvement', 'QOL', 'quality of life (QOL', 'worse depression', 'average PHQ-9 score', 'Patient Health Questionnaire 9 (PHQ-9) and Quality of Life Assessment (QOLA) scores respectively measured depression severity and QOL of participants', 'average QOLA score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0319654,"The adapted collaborative care model provided an affordable, effective method of older adult depression management within the contexts of this clinical study.","[{'ForeName': 'Victor Ross', 'Initials': 'VR', 'LastName': 'Bench', 'Affiliation': 'Department of Acute & Tertiary Care, University of Pittsburgh, School of Nursing , Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beach', 'Affiliation': 'Department of Acute & Tertiary Care, University of Pittsburgh, School of Nursing , Pittsburgh, PA, USA.'}, {'ForeName': 'Dianxu', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': 'Department of Health & Community Systems, University of Pittsburgh, School of Nursing , Pittsburgh, PA, USA.'}]",Journal of evidence-based social work (2019),['10.1080/26408066.2020.1768193'] 2318,32573382,Stop Signal Task Training Strengthens GABA-mediated Neurotransmission within the Primary Motor Cortex.,"We have recently shown that the efficiency in stopping a response, measured using the stop signal task, is related to GABA A -mediated short-interval intracortical inhibition (SICI) in the primary motor cortex. In this study, we conducted two experiments on humans to determine whether training participants in the stop signal task within one session (Experiment 1) and across multiple sessions (Experiment 2) would increase SICI strength. For each experiment, we obtained premeasures and postmeasures of stopping efficiency and resting-state SICI, that is, during relaxed muscle activity (Experiment 1, n = 45, 15 males) and SICI during the stop signal task (Experiment 2, n = 44, 21 males). In the middle blocks of Experiment 1 and the middle sessions of Experiment 2, participants in the experimental group completed stop signal task training, whereas control participants completed a similar task without the requirement to stop a response. After training, the experimental group showed increased resting-state SICI strength (Experiment 1) and increased SICI strength during the stop signal task (Experiment 2). Although there were no overall behavioral improvements in stopping efficiency, improvements at an individual level were correlated with increases in SICI strength at rest (Experiment 1) and during successful stopping (Experiment 2). These results provide evidence of neuroplasticity in resting-state and task-related GABA A -mediated SICI in the primary motor cortex after response inhibition training. These results also suggest that SICI and stopping efficiency are temporally linked, such that a change in SICI between time points is correlated with a change in stopping efficiency between time points.",2020,"Although there were no overall behavioral improvements in stopping efficiency, improvements at an individual level were correlated with increases in SICI strength at rest (Experiment 1) and during successful stopping (Experiment 2).",[],['stop signal task training'],"['SICI strength', 'resting-state SICI strength']",[],"[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.0132836,"Although there were no overall behavioral improvements in stopping efficiency, improvements at an individual level were correlated with increases in SICI strength at rest (Experiment 1) and during successful stopping (Experiment 2).","[{'ForeName': 'Nahian S', 'Initials': 'NS', 'LastName': 'Chowdhury', 'Affiliation': 'The University of Sydney.'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Livesey', 'Affiliation': 'The University of Sydney.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Harris', 'Affiliation': 'The University of Sydney.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01597'] 2319,32573396,"Quality of Life Impacts of Bright Light Treatment, Fluoxetine, and the Combination in Patients with Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial.","OBJECTIVE Bright light therapy is increasingly recommended (alone or in combination with antidepressant medication) to treat symptoms of nonseasonal major depressive disorder (MDD). However, little is known about its impacts on quality of life (QoL), a holistic, patient-valued outcome. METHODS This study utilizes secondary outcome data from an 8-week randomized, controlled, double blind trial comparing light monotherapy ( n = 32), fluoxetine monotherapy ( n = 30), and the combination of these ( n = 27) to placebo ( n = 30). QoL was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF). Treatment-related differences in QoL improvements were assessed using a repeated measures analysis of variance. The influence of potential predictors of QoL (demographic variables and change in depressive symptoms) were investigated via hierarchical linear regression. RESULTS Q-LES-Q-SF scores significantly improved across all treatment conditions; however, no significant differences were observed between treatment arms. QoL remained poor relative to community norms by the end of the trial period: Across conditions, 70.6% of participants had significantly impaired QoL at the 8-week assessment. Reduction in depressive scores was a significant predictor of improved QoL, with the final model accounting for 54% of variance in QoL change scores. CONCLUSION The findings of this study emphasize that improvement in QoL and reduction in depressive symptoms in MDD, while related, cannot be taken to be synonymous. Adjunctive therapies may be required to address unmet QoL needs in patients with MDD receiving antidepressant or light therapies. Further research is required to explore additional predictors of QoL in order to better refine treatments for MDD.",2020,"RESULTS Q-LES-Q-SF scores significantly improved across all treatment conditions; however, no significant differences were observed between treatment arms.","['patients with MDD receiving antidepressant or light therapies', 'Patients with Nonseasonal Major Depressive Disorder']","['light monotherapy', 'Bright Light Treatment, Fluoxetine', 'placebo', 'fluoxetine monotherapy']","['QoL improvements', 'quality of life (QoL', 'Q-LES-Q-SF scores', 'depressive scores', 'QoL (demographic variables and change in depressive symptoms', 'Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0227192', 'cui_str': 'Inferior esophageal sphincter structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",,0.183771,"RESULTS Q-LES-Q-SF scores significantly improved across all treatment conditions; however, no significant differences were observed between treatment arms.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Levitt', 'Affiliation': 'Department of Psychiatry, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Levitan', 'Affiliation': 'Department of Psychiatry, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychiatry, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Morehouse', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Department of Psychiatry/Clinical Neurosciences, Mathison Center for Mental Health Research and Education, Hotchkiss Brain Institute, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Lakshmi N', 'Initials': 'LN', 'LastName': 'Yatham', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Edwin M', 'Initials': 'EM', 'LastName': 'Tam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720936470'] 2320,32573426,Rapid and sustained improvements in patient-reported signs and symptoms with ixekizumab in biologic-naive and TNF-inadequate responder patients with psoriatic arthritis.,"OBJECTIVES To analyse the onset and sustainability of patient-reported improvements in symptoms of psoriatic arthritis (PsA) following treatment with ixekizumab (IXE) up to Week 108. METHODS In patients with active PsA, either naive to biological DMARDs (SPIRIT-P1) or having inadequate response or intolerance to 1 or 2 prior TNF-inhibitors (TNFi‑experienced; SPIRIT-P2), we analysed the change from baseline in joint pain visual analogue scale (VAS; 0-100 scale), patient global assessment (PatGA VAS; 0-100 scale), fatigue numerical rating scale (NRS; 0 [no fatigue] to 10 [worst imaginable]), and Health Assessment Questionnaire-Disability Index (HAQ-DI; 0-3), up to Week 108. RESULTS IXE-treated patients compared to placebo reported rapid and statistically significant improvement in pain VAS, PatGA, and HAQ-DI as early as Week 1 and this benefit was sustained or increased through Week 108. Fatigue scores improved in IXE-treated patients compared to placebo in both studies; results were statistically significant at Week 24 only in SPIRIT-P2. Improvements in fatigue with IXE were sustained over 2 years. The improvements observed in these patient-reported outcomes (PROs) were consistent in biologic-naive or TNFi-experienced patients. CONCLUSIONS Patients treated with IXE versus PBO achieved significantly greater improvements and showed faster onset of improvements in patient-reported outcomes measuring symptoms and impact of PsA. Responses were sustained over 2 years and were generally consistent regardless of prior TNFi experience.",2020,Fatigue scores improved in IXE-treated patients compared to placebo in both studies; results were statistically significant at Week 24 only in SPIRIT-P2.,[],"['ixekizumab (IXE', 'IXE versus PBO', 'placebo']","['fatigue with IXE', 'Fatigue scores', 'joint pain visual analogue scale (VAS; 0-100 scale), patient global assessment (PatGA VAS; 0-100 scale), fatigue numerical rating scale (NRS; 0', 'pain VAS, PatGA, and HAQ-DI', 'Health Assessment Questionnaire-Disability Index']",[],"[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0511214,Fatigue scores improved in IXE-treated patients compared to placebo in both studies; results were statistically significant at Week 24 only in SPIRIT-P2.,"[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. aorbai1@jhmi.edu.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Goto', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Birt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Gellett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tore K', 'Initials': 'TK', 'LastName': 'Kvien', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}]",Clinical and experimental rheumatology,[] 2321,32573729,Hemogram-based decision tree for predicting the metabolic syndrome and cardiovascular diseases in the elderly.,"BACKGROUND This study aimed to build a hemogram-based decision tree to evaluate the association between current probability of metabolic syndrome (MetS) and prediction of future hypertension, type 2 diabetes, and cardiovascular diseases (CVD) risk. METHODS A total of 40,395 elder participants (≥60 years) were enrolled in a standard health examination program in Taiwan from January 1999 to December 2014. A decision tree classification of the presence or absence of MetS at baseline, using age, sex, and hemogram (white blood cell, hemoglobin, and platelet) as independent variables, was conducted for the randomly assigned training (70%) and validation (30%) groups. Participants without MetS at baseline (n = 25,643) were followed up to observe whether they developed MetS, hypertension, type 2 diabetes, or CVD in the future. RESULTS Modest accuracy of the decision tree in the training and validation groups with area under the curves of 0.653 and 0.652, respectively, indicated an acceptable generalizability of results. The predicted probability of baseline MetS was obtained from decision tree analysis. Participants without MetS at baseline were categorized into three equally-sized groups according to the predicted probability. Participants in the third tertile had significantly higher risks of future MetS (hazard ratio 1.40, 95% confidence interval 1.25-1.58); type 2 diabetes (1.46, 1.17-1.83); hypertension (1.14, 1.01-1.28); and CVD (1.21, 1.01-1.44), compared with those in the first tertile. CONCLUSIONS Execution of hemogram-based decision tree analysis can assist in early identification and prompt management of elderly patients at a high risk of future hypertension, type 2 diabetes, and CVD.",2020,"Participants in the third tertile had significantly higher risks of future MetS (hazard ratio 1.40, 95% confidence interval 1.25-1.58); type 2 diabetes (1.46, 1.17-1.83); hypertension (1.14, 1.01-1.28); and CVD (1.21, 1.01-1.44), compared with those in the first tertile. ","['40,395 elder participants (≥60 years) were enrolled in a standard health examination program in Taiwan from January 1999 to December 2014', 'elderly patients', 'Participants without MetS at baseline (n\u2009=\u200925,643']",[],"['CVD', 'hypertension', 'risks of future MetS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",40395.0,0.0516159,"Participants in the third tertile had significantly higher risks of future MetS (hazard ratio 1.40, 95% confidence interval 1.25-1.58); type 2 diabetes (1.46, 1.17-1.83); hypertension (1.14, 1.01-1.28); and CVD (1.21, 1.01-1.44), compared with those in the first tertile. ","[{'ForeName': 'Chun-Hsien', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Family Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yen-Lin', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei, Taiwan.'}, {'ForeName': 'Chang-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yao-Jen', 'Initials': 'YJ', 'LastName': 'Liang', 'Affiliation': 'Department of Life Science, Graduate Institute of Applied Science and Engineering, College of Science and Engineering, Fu Jen Catholic University, New Taipei, Taiwan.'}, {'ForeName': 'Shu-Hsiang', 'Initials': 'SH', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, College of Nursing, National Taipei University of Nursing and Health Science, Taipei, Taiwan.'}, {'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Pei', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei, Taiwan.'}]",QJM : monthly journal of the Association of Physicians,['10.1093/qjmed/hcaa205'] 2322,32573767,Information on early medical abortion for women using an audiovisual animation versus face to face consultation: a consortium randomized and quasi-randomized trial.,"INTRODUCTION There is some evidence that audiovisual formats can be an effective way of providing information about early medical abortion (EMA). A short animation (three minutes) was developed about EMA in three languages that summarised the EMA process for use in the UK, France and Sweden. MATERIAL AND METHODS We conducted a multicentre randomised controlled trial to compare information on EMA delivered by the animation versus a face-to-face consultation. Women requesting EMA (<=9 weeks gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited. The primary outcome was women's recall of prespecified key information on EMA. Secondary outcomes were acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale. The study was prospectively registered with clinicaltrials.gov, ID number: NCT03417362. RESULTS 172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48). There was no statistically significant difference in recall scores between animation and standard arms in Edinburgh and Stockholm sites. However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation. All participants in the animation arm rated it as an acceptable way to receive information on EMA. CONCLUSIONS A 'short' audiovisual animation can adequately and acceptably deliver key information about EMA. This intervention could be used routinely to provide standardised and high-quality information to women seeking EMA.",2020,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","['Women requesting EMA (<=9 weeks gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited', '172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48']",['audiovisual animation'],"['recall scores', ""women's recall of prespecified key information on EMA"", 'acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000789', 'cui_str': 'Abortion Clinics'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376650', 'cui_str': 'Animation'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",172.0,0.142109,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Reynolds-Wright', 'Affiliation': 'MRC Centre for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Belleuvre', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Daberius', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Faucher', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'MRC Centre for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13944'] 2323,32573773,Finding a way in daily clinical practice during Covid-19 pandemic.,"Since some months, the Covid-19 pandemic changed our world drastically. At the start of the pandemic, in a single week, our medical communities, both in primary care , nursing homes, as in secondary and tertiary facilities have been forced to stop all regular clinical care and to shift towards hospital care that was ultimately restricted to Covid-19 related disease. The clinical presentation of Covid-19 occurred predominantly in the elderly patients (most > 65 years old) displaying a respiratory disability, and in a small proportion among them displayed a respiratory failure, in association with a broad range of pre-existing co-morbidities. Covid-19 had not been taught in university and to prepare ourselves, we aimed to retract data published from especially Chinese studies. Most literature was published without a peer-review procedure (fast track), and most intervention designs existed of small groups and a not blinded/not randomized inclusion. After an extensive week of patients' contact, we experienced various differences (compared to the prior reports) in their first presentation and in their individual course of disease.",2020,"At the start of the pandemic, in a single week, our medical communities, both in primary care , nursing homes, as in secondary and tertiary facilities have been forced to stop all regular clinical care and to shift towards hospital care that was ultimately restricted to Covid-19 related disease.",[],[],[],[],[],[],,0.0334595,"At the start of the pandemic, in a single week, our medical communities, both in primary care , nursing homes, as in secondary and tertiary facilities have been forced to stop all regular clinical care and to shift towards hospital care that was ultimately restricted to Covid-19 related disease.","[{'ForeName': 'Marcel B', 'Initials': 'MB', 'LastName': 'Twickler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolic Disease, AZ Monica, Antwerp, Belgium.'}, {'ForeName': 'Jakub J', 'Initials': 'JJ', 'LastName': 'Regieli', 'Affiliation': 'European Society of Clinical Investigation, Journal Foundation President, Utrecht, the Netherlands.'}]",European journal of clinical investigation,['10.1111/eci.13329'] 2324,32573779,"Oncological outcomes for patients with locally advanced prostate cancer treated with neoadjuvant endocrine and external-beam radiation therapy followed by adjuvant continuous/intermittent endocrine therapy in an open-label, randomized, phase 3 trial.","BACKGROUND To date, research has not determined the optimal procedure for adjuvant androgen deprivation therapy (ADT) in patients with locally advanced prostate cancer (PCa) treated for 6 months with neoadjuvant ADT and external-beam radiation therapy (EBRT). METHODS A multicenter, randomized, phase 3 trial enrolled 303 patients with locally advanced PCa between 2001 and 2006. Participants were treated with neoadjuvant ADT for 6 months. Then, 280 patients whose prostate-specific antigen levels were less than pretreatment levels and less than 10 ng/mL were randomized. All 280 participants were treated with 72 Gy of EBRT in combination with adjuvant ADT for 8 months. Thereafter, participants were assigned to long-term ADT (5 years in all; arm 1) or intermittent ADT (arm 2). The primary endpoint was modified biochemical relapse-free survival (bRFS) with respect to nonmetastatic castration-resistant prostate cancer (nmCRPC) progression, clinical relapse, or any cause of death. RESULTS The median follow-up time after randomization was 8.2 years. Among the 136 and 144 men assigned to trial arms 1 and 2, respectively, 24 and 30 progressed to nmCRPC or clinical relapse, and 5 and 6 died of PCa. The 5-year modified bRFS rates were 84.8% and 82.8% in trial arms 1 and 2, respectively (hazard ratio, 1.132; 95% confidence interval, 0.744-1.722). CONCLUSIONS Although modified bRFS data did not demonstrate noninferiority for arm 2, intermittent adjuvant ADT after EBRT with 14 months of neoadjuvant and short-term adjuvant ADT is a promising treatment strategy, especially in a population of responders after 6 months of ADT for locally advanced PCa.",2020,"Although modified bRFS data did not demonstrate noninferiority for arm 2, intermittent adjuvant ADT after EBRT with 14 months of neoadjuvant and short-term adjuvant ADT is a promising treatment strategy, especially in a population of responders after 6 months of ADT for locally advanced PCa.","['280 patients whose prostate-specific antigen levels were less than pretreatment levels and less than 10\xa0ng/mL were randomized', '136 and 144 men assigned to trial arms 1 and 2, respectively, 24 and 30 progressed to nmCRPC or clinical relapse, and 5 and 6 died of PCa', '303 patients with locally advanced PCa between 2001 and 2006', 'patients with locally advanced prostate cancer (PCa) treated for 6\xa0months with', 'patients with locally advanced prostate cancer treated with', 'All 280 participants were treated with 72\xa0Gy of']","['neoadjuvant ADT', 'EBRT in combination with adjuvant ADT', 'adjuvant androgen deprivation therapy (ADT', 'intermittent ADT', 'neoadjuvant endocrine and external-beam radiation therapy followed by adjuvant continuous/intermittent endocrine therapy', 'neoadjuvant ADT and external-beam radiation therapy (EBRT']","['modified biochemical relapse-free survival (bRFS) with respect to nonmetastatic castration-resistant prostate cancer (nmCRPC) progression, clinical relapse, or any cause of death', '5-year modified bRFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",303.0,0.149061,"Although modified bRFS data did not demonstrate noninferiority for arm 2, intermittent adjuvant ADT after EBRT with 14 months of neoadjuvant and short-term adjuvant ADT is a promising treatment strategy, especially in a population of responders after 6 months of ADT for locally advanced PCa.","[{'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Isesaki Municipal Hospital, Isesaki, Japan.'}, {'ForeName': 'Motokiyo', 'Initials': 'M', 'LastName': 'Komiyama', 'Affiliation': 'Department of Urology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Kyusyu University, Fukuoka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Urology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yonese', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Hashine', 'Affiliation': 'Department of Urology, Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Urology, Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Arai', 'Affiliation': 'Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Shinohara', 'Affiliation': 'Department of Urology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Masumori', 'Affiliation': 'Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shimizu', 'Affiliation': 'Department of Urology, Gunma Cancer Center Hospital, Ohta, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Urology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Urology, Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Tochigi', 'Affiliation': 'Department of Urology, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takezawa', 'Affiliation': 'Department of Urology, Isesaki Municipal Hospital, Isesaki, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yokomizo', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Kyusyu University, Fukuoka, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Kakimoto', 'Affiliation': 'Department of Urology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Iwao', 'Initials': 'I', 'LastName': 'Fukui', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Karasawa', 'Affiliation': 'Department of Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Tsukamoto', 'Affiliation': 'Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Miwako', 'Initials': 'M', 'LastName': 'Nozaki', 'Affiliation': 'Department of Radiation Oncology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Hasumi', 'Affiliation': 'Department of Urology, Gunma Cancer Center Hospital, Ohta, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Ishiyama', 'Affiliation': 'Department of Radiation and Radiation Oncology, Kitasato University, Sagamihara, Japan.'}, {'ForeName': 'Mikinobu', 'Initials': 'M', 'LastName': 'Ohtani', 'Affiliation': 'Department of Urology, Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Kuwahara', 'Affiliation': 'Sendai Jin-Hinyokika, Sendai, Japan.'}, {'ForeName': 'Masaoki', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Kotake', 'Affiliation': 'Kotake Clinic, Osaka, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Kakizoe', 'Affiliation': 'Japan Society for Cancer, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': 'Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer,['10.1002/cncr.33034'] 2325,32573782,Laparoscopic versus open colorectal surgery in the acute setting (LaCeS trial): a multicentre randomized feasibility trial.,"BACKGROUND Approximately 30 000 people undergo major emergency abdominal gastrointestinal surgery annually, and 36 per cent of these procedures (around 10 800) are carried out for emergency colorectal pathology. Some 14 per cent of all patients requiring emergency surgery have a laparoscopic procedure. The aims of the LaCeS (laparoscopic versus open colorectal surgery in the acute setting) feasibility trial were to assess the feasibility, safety and acceptability of performing a large-scale definitive phase III RCT, with a comparison of emergency laparoscopic versus open surgery for acute colorectal pathology. METHODS LaCeS was designed as a prospective, multicentre, single-blind, parallel-group, pragmatic feasibility RCT with an integrated qualitative study. Randomization was undertaken centrally, with patients randomized on a 1 : 1 basis between laparoscopic or open surgery. RESULTS A total of 64 patients were recruited across five centres. The overall mean steady-state recruitment rate was 1·2 patients per month per site. Baseline compliance for clinical and health-related quality-of-life data was 99·8 and 93·8 per cent respectively. The conversion rate from laparoscopic to open surgery was 39 (95 per cent c.i. 23 to 58) per cent. The 30-day postoperative complication rate was 27 (13 to 46) per cent in the laparoscopic arm and 42 (25 to 61) per cent in the open arm. CONCLUSION Laparoscopic emergency colorectal surgery may have an acceptable safety profile. Registration number: ISRCTN15681041 ( http://www.controlled-trials.com).",2020,The conversion rate from laparoscopic to open surgery was 39,"['Approximately 30\u2009000 people undergo major emergency abdominal gastrointestinal surgery annually, and 36 per cent of these procedures (around 10\u2009800) are carried out for emergency colorectal pathology', '64 patients were recruited across five centres']","['LaCeS (laparoscopic versus open colorectal surgery', 'Laparoscopic emergency colorectal surgery', 'Laparoscopic versus open colorectal surgery', 'emergency laparoscopic versus open surgery', 'laparoscopic or open surgery']","['Baseline compliance for clinical and health-related quality-of-life data', '30-day postoperative complication rate', 'overall mean steady-state recruitment rate', 'conversion rate', 'feasibility, safety and acceptability']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0453991', 'cui_str': 'Laces'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",64.0,0.291453,The conversion rate from laparoscopic to open surgery was 39,"[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Harji', 'Affiliation': 'Department of Colorectal Surgery, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': 'Clinical Trials Research Unit, Leeds, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gordon', 'Affiliation': 'Clinical Trials Research Unit, Leeds, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Twiddy', 'Affiliation': 'Institute of Clinical and Applied Health Research, University of Hull, Hull, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pullan', 'Affiliation': 'Clinical Trials Research Unit, Leeds, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Croft', 'Affiliation': 'Clinical Trials Research Unit, Leeds, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Burke', 'Affiliation': ""Department of Colorectal Surgery, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Griffiths', 'Affiliation': 'Department of Colorectal Surgery, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Verjee', 'Affiliation': 'Patient and Public Involvement Representative for LaCeS Trial, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sagar', 'Affiliation': ""Department of Colorectal Surgery, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stocken', 'Affiliation': 'Clinical Trials Research Unit, Leeds, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.11703'] 2326,32573927,Exenatide ER in patients with Type 1 diabetes with and without residual insulin production.,"BACKGROUND Glucagon-like peptide-1 receptor agonists (GLP1RA) have activity that may benefit patients with Type 1 diabetes (T1D). Studies of GLP1RAs in T1D had mixed outcomes possibly because their effects in patients with residual insulin production were not been specifically addressed. METHODS We performed a randomized placebo controlled trial of exenatide ER in participants with T1D with and without detectable levels of C-peptide. Seventy-nine participants were randomized to exenatide ER 2 mcg weekly or placebo, stratified by the presence or absence of detectable C-peptide levels. The primary outcome was the difference in HbA1c levels at 24 weeks. Participants were followed for another 6 months off study drug. RESULTS At week 24, the time of the primary outcome, the HbA1c level was (LS mean [95% CI]) 7.76%(7.42, 8.10) vs. 8.0% (7.64, 8.35) in the drug vs placebo treatment groups (p = 0.08). At week12 the HbA1c levels were(exenatide ER: 7.71% (7.37, 8.05) vs placebo: 8.05% (7.7, 8.4))(p = 0.01)).The improvement at week 12 was driven mainly by those with detectable levels of C-peptide. Those treated with exenatide ER lost weight at 12 and 24 weeks compared to placebo (p < 0.001 and p = 0.007). The total dose of insulin was lower, but not when corrected for body weight, and was not affected by residual insulin production. Adverse events were more frequent with exenatide ER, but hypoglycemia was not increased. CONCLUSION Treatment with exenatide ER may have short-term benefits in some individuals with T1D who are overweight or with detectable levels of C-peptide, but short term improvements were not sustained. ClinicalTrials.gov: NCT01928329. This article is protected by copyright. All rights reserved.",2020,Those treated with exenatide ER lost weight at 12 and 24 weeks compared to placebo (p < 0.001 and p = 0.007).,"['patients with Type 1 diabetes (T1D', 'participants with T1D with and without detectable levels of C-peptide', 'Seventy-nine participants', 'patients with Type 1 diabetes with and without residual insulin production']","['exenatide ER 2 mcg weekly or placebo', 'Exenatide ER', 'Glucagon-like peptide-1 receptor agonists (GLP1RA', 'exenatide ER', 'placebo']","['Adverse events', 'hypoglycemia', 'HbA1c level', 'total dose of insulin', 'HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",79.0,0.485484,Those treated with exenatide ER lost weight at 12 and 24 weeks compared to placebo (p < 0.001 and p = 0.007).,"[{'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Departments of Immunobiology, United States.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Biostatics, and, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Internal Medicine (Endocrinology), United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baidal', 'Affiliation': 'Department of Medicine (Endocrinology), University of Miami, Miami, Florida, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gaglia', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, United States.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': 'Department of Pediatrics (Endocrinology), University of California at San Francisco.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': 'Barbara Davis Diabetes Center, University of Colorado, Anschutz, CO, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Marks', 'Affiliation': 'Department of Medicine (Endocrinology), University of Miami, Miami, Florida, United States.'}, {'ForeName': 'Louis H', 'Initials': 'LH', 'LastName': 'Philipson', 'Affiliation': 'Department of Medicine (Endocrinology), The University of Chicago, Chicago, Illinois, United States.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Department of Medicine (Endocrinology), The University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'Department of Medicine (Endocrinology), SUNY Upstate Medical University, Syracuse, New York, United States.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14121'] 2327,32573956,"Safety and Pharmacokinetics of High-Dose TAS-303 in Healthy Japanese Volunteers: A Single-Center, Single-Blind, Randomized, Placebo-Controlled, Parallel-Group Multiple-Ascending-Dose Study.","Preclinical data of TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d 7 ] acetate hydrochloride), a noradrenaline reuptake inhibitor, show that it increases urethral contraction in rats and may therefore benefit stress urinary incontinence patients. In this single-blind, randomized, placebo-controlled, parallel-group, multiple-ascending-dose phase 1 study, we evaluated the safety and tolerability of once-daily TAS-303 8, 10, 12, 15, or 18 mg administered for 16 days in healthy subjects. In addition, we investigated the pharmacokinetics and inhibitory effect of TAS-303 on hepatic cytochrome P450 (CYP) 3A activity. Rates of adverse events, adverse drug reactions, and pharmacokinetic parameters of TAS-303 were evaluated. Fifty subjects were randomized: 7 subjects each were assigned to receive TAS-303 8-18 mg, and 3 subjects each were assigned to receive placebo at each dose. The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively. No deaths or serious adverse events occurred. TAS-303 displayed a dose-proportional pharmacokinetic profile across doses of 8-18 mg over the 16-day multiple administration period, and TAS-303 might inhibit hepatic CYP3A activity within this dose range. TAS-303 at a dose of 8-18 mg was confirmed to be safe and tolerable.",2020,"The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively.","['healthy subjects', 'Healthy Japanese Volunteers', 'stress urinary incontinence patients', 'Fifty subjects were randomized: 7 subjects each']","['Placebo', 'TAS-303', 'TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d 7 ] acetate hydrochloride', 'High-Dose TAS-303', 'placebo']","['hepatic cytochrome P450 (CYP) 3A activity', 'deaths or serious adverse events', 'hepatic CYP3A activity', 'safety and tolerability', 'safe and tolerable', 'adverse events and adverse drug reactions', 'urethral contraction', 'Rates of adverse events, adverse drug reactions, and pharmacokinetic parameters of TAS-303', 'Safety and Pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0058372', 'cui_str': 'Diphenyl'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}]",50.0,0.251432,"The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively.","[{'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Hanada', 'Affiliation': 'SOUSEIKAI Sumida Hospital, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.801'] 2328,32568593,"Letter to the Editor RE: Giusti et al., Editorial Comment on: Influence of Lower Pole Infundibulopelvic Angle on Success of Retrograde Flexible Ureteroscopy and Laser Lithotripsy for the Treatment of Renal Stones by Dresner et al. (J Endourol 2020;34(6):660-661; DOI: 10.1089/end.2020.0209).",,2020,,[],['Retrograde Flexible Ureteroscopy and Laser Lithotripsy'],[],[],"[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}]",[],,0.0156807,,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dresner', 'Affiliation': 'Department of Urology, University of Wisconsin-Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Nakada', 'Affiliation': 'Department of Urology, University of Wisconsin-Madison, Madison, Wisconsin, USA.'}]",Journal of endourology,['10.1089/end.2020.29087.sld'] 2329,32568601,The effect of transferring weekend physical therapy services from the acute to sub-acute setting in patients following hip and knee arthroplasty: a quasi-experimental study.,"BACKGROUND Weekend physical therapy services in the acute and/or sub-acute setting may optimize postoperative recovery following hip and knee arthroplasty, though evidence supporting these services is limited. PURPOSE To explore the change in patient and service outcomes of transferring a weekend physical therapy service from the acute to the sub-acute setting following hip and knee arthroplasty. METHODS This was a quasi-experimental research design nested within two stepped-wedge cluster randomized controlled trials. Acute weekend physical therapy services were sequentially discontinued and reallocated to the sub-acute setting in a random order from one ward at a time within the broader trial. Patient and service outcomes for participants 6 weeks following hip and knee arthroplasty (N = 247) were compared during 6 months of acute weekend physical therapy services (Phase 1, n = 117) followed by 6 months of sub-acute services (Phase 2, n = 130). Intention-to-treat statistical analyses were conducted. RESULTS The intervention had a negligible effect on medium-term outcomes. The only statistically significant difference observed was slightly higher ratings of ""worst pain experienced over the past week"" [coefficient 0.865 (0.123 to 1.606), p = .022] during Phase 2. No interaction effects were observed despite a 2.4-day reduction in length of stay amongst complex patients during Phase 2 (18.28 and 15.86 days in Phase 1 and 2, respectively). CONCLUSIONS No comparative advantage or disadvantage was observed by reallocating a weekend physical therapy budget from the acute to sub-acute setting following hip and knee arthroplasty. Further research investigating the cost-effectiveness of these services in the sub-acute setting may be warranted for complex patients.",2020,"No interaction effects were observed despite a 2.4-day reduction in length of stay amongst complex patients during Phase 2 (18.28 and 15.86 days in Phase 1 and 2, respectively). ","['participants 6 weeks following hip and knee arthroplasty', 'patients following hip and knee arthroplasty']","['transferring weekend physical therapy services', 'transferring a weekend physical therapy service']","['length of stay', 'ratings of ""worst pain']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0587629', 'cui_str': 'Physiotherapy service'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",247.0,0.0623169,"No interaction effects were observed despite a 2.4-day reduction in length of stay amongst complex patients during Phase 2 (18.28 and 15.86 days in Phase 1 and 2, respectively). ","[{'ForeName': 'Romi', 'Initials': 'R', 'LastName': 'Haas', 'Affiliation': 'Monash Department of Clinical Epidemiology, Cabrini Institute , Malvern, Australia.'}, {'ForeName': 'Kelly-Ann', 'Initials': 'KA', 'LastName': 'Bowles', 'Affiliation': 'Department of Community Emergency Health and Paramedics, Monash University and Monash Health Allied Health Research Unit , Frankston, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Occupational Therapy, Monash University and Monash Health Allied Health Research Unit , Frankston, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University and Monash Health Allied, Health Research Unit , Frankston, Australia.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1777604'] 2330,32568651,Theophylline as an Add-On to Thrombolytic Therapy in Acute Ischemic Stroke: A Randomized Placebo-Controlled Trial.,"BACKGROUND AND PURPOSE Delayed recanalization increases the risk of infarct growth and poor clinical outcome in acute ischemic stroke. The vasoactive agent theophylline has shown neuroprotective effects in animal stroke models but inconclusive results in case series and randomized clinical trials. The primary objective of this study was to evaluate whether theophylline, as an add-on to thrombolytic therapy, is safe and effective in acute ischemic stroke patients. METHODS The TEA-Stroke trial (The Theophylline in Acute Ischemic Stroke) was an investigator-initiated 2-center, proof-of-concept, phase II clinical study with a randomized, double-blinded, placebo-controlled design. The main inclusion criteria were magnetic resonance imaging-verified acute ischemic stroke, moderate to severe neurological deficit (National Institutes of Health Stroke Scale score of ≥4), and treatment with thrombolysis within 4.5 hours of onset. Participants were randomly assigned in the ratio 1:1 to either 220 mg of intravenous theophylline or placebo. The co-primary outcomes were early clinical improvement on the National Institutes of Health Stroke Scale score and infarct growth on magnetic resonance imaging at 24-hour follow-up. RESULTS Theophylline as an add-on to thrombolytic therapy improved the National Institutes of Health Stroke Scale score at 24 hours by mean 4.7 points (SD, 5.6) compared with an improvement of 1.3 points (SD, 7.5) in the control group ( P =0.044). Mean infarct growth was 141.6% (SD, 126.5) and 104.1% (SD, 62.5) in the theophylline and control groups, respectively ( P =0.146). Functional independence at 90 days was 61% in the theophylline group and 58% in the control group ( P =0.802). CONCLUSIONS This proof-of-concept trial investigated theophylline administration as an add-on to thrombolytic therapy in acute ischemic stroke. The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique). The small study size precludes a conclusion as to whether theophylline has a neuroprotective effect but provides a promising clinical signal that may support a future clinical trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: EudraCT number 2013-001989-42.",2020,The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique).,"['acute ischemic stroke', 'acute ischemic stroke patients', 'Acute Ischemic Stroke', 'acute ischemic stroke, moderate to severe neurological deficit (National Institutes of Health Stroke Scale score of ≥4), and treatment with thrombolysis within 4.5 hours of onset']","['Placebo', 'vasoactive agent theophylline', 'Theophylline', 'theophylline or placebo', 'theophylline', 'placebo']","['Mean infarct growth', 'Functional independence', 'National Institutes of Health Stroke Scale score and infarct growth on magnetic resonance imaging at 24-hour follow-up', 'infarct growth', 'National Institutes of Health Stroke Scale score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.545742,The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique).,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Modrau', 'Affiliation': 'Departments of Neurology (B.M., F.W.B.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Departments of Neurology (G.A., N.H.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Irene Klærke', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Nielsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Mikkel Bo', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Martin Berg', 'Initials': 'MB', 'LastName': 'Johansen', 'Affiliation': 'Unit of Clinical Biostatistics (M.B.J.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Helle Wulf', 'Initials': 'HW', 'LastName': 'Eskildsen', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Jan Plougmann', 'Initials': 'JP', 'LastName': 'Povlsen', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Yavarian', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mouridsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Neuroradiology (L.Ø.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Flemming Winther', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': 'Departments of Neurology (B.M., F.W.B.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hjort', 'Affiliation': 'Departments of Neurology (G.A., N.H.), Aarhus University Hospital, Denmark.'}]",Stroke,['10.1161/STROKEAHA.119.027446'] 2331,32577819,Switching from Warfarin to rivaroxaban induces sufficiency of vitamin K and reduction of arterial stiffness in patients with atrial fibrillation.,"Use of chronic vitamin K antagonist (VKA) induces a long-term deficiency of vitamin K, which may cause arterial stiffness and bone-related disease. Switching from VKA to rivaroxaban could induce rapid sufficiency of vitamin K and improvement of arterial stiffness. The K2 SUMMIT-3 study is a multicenter, open-label, prospective, and randomized design. Patients with atrial fibrillation who have been taking VKA for more than 6 months but less than 10 years were randomly assigned to two groups; those switching from VKA to rivaroxaban and those continuing with VKA medication. The primary endpoint was the percentage difference of brachial-ankle pulse wave velocity (baPWV) in 3 months. A total of 77 patients were randomly assigned to receive rivaroxaban (n = 38) or VKA (n = 39). The average age was 74 ± 9 years. The duration for which VKA was prescribed prior to randomization was 90 ± 87 months.Abnormally high levels of Des-gamma carboxyprothrombin (PIVKA-II) or uncarboxylated osteocalcin (ucOC) indicating vitamin K insufficiency were observed in 100% or 82% of the patients at baseline but it reduced to 2% (p < 0.0001) or 55% (p = 0.01) at 3 months in the rivaroxaban group. To the contrary, theses data had no changes in the VKA group. The percentage difference in baPWV was - 1.4 ± 10.0% vs. 3.5 ± 14.7% in the rivaroxaban and the VKA groups, respectively. (p = 0.02). Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.",2020,Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.,"['Patients with atrial fibrillation who have been taking VKA for more than 6\xa0months but less than 10\xa0years', 'A total of 77 patients', 'patients with atrial fibrillation']","['rivaroxaban', 'VKA', 'chronic vitamin K antagonist (VKA']","['Abnormally high levels of Des-gamma carboxyprothrombin (PIVKA-II) or uncarboxylated osteocalcin (ucOC) indicating vitamin K insufficiency', 'arterial stiffness', 'rapid sufficiency of vitamin K and reduction of arterial stiffness', 'percentage difference of brachial-ankle pulse wave velocity (baPWV', 'baPWV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C1299351', 'cui_str': 'Abnormally high'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0950248', 'cui_str': 'Des-gamma-carboxy prothrombin'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",77.0,0.0510437,Switching from VKA to rivaroxaban resulted in rapid sufficiency of vitamin K and reduction of arterial stiffness in 3 months.,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan. ikari@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Fumie', 'Initials': 'F', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Kiyooka', 'Affiliation': 'Tokai University Oiso Hospital, Oiso, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Nagaoka', 'Affiliation': 'Ebina General Hospital, Ebina, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Tokai University Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Takamoto', 'Initials': 'T', 'LastName': 'Furuki', 'Affiliation': 'Hadano South Gate Clinic, Hadano, Japan.'}, {'ForeName': 'Shigemitsu', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Tokai University Oiso Hospital, Oiso, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01651-8'] 2332,32577826,Every ureteral stone deserves conventional management prior to intervention.,,2020,,[],[],[],[],[],[],,0.0120349,,"[{'ForeName': 'Senol', 'Initials': 'S', 'LastName': 'Tonyali', 'Affiliation': 'Department of Urology, Istanbul University Istanbul School of Medicine, Cerrahi Monoblok Kat:1 Capa-Fatih, Istanbul, Turkey. senoltonyali@hotmail.com.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Turan', 'Affiliation': 'Department of Urology, Istanbul University Istanbul School of Medicine, Cerrahi Monoblok Kat:1 Capa-Fatih, Istanbul, Turkey.'}]",World journal of urology,['10.1007/s00345-020-03317-6'] 2333,32577871,Efficacy of cyanoacrylate in the prevention of delayed bleeding after endoscopic mucosal resection of large colorectal polyps: a pilot study.,"BACKGROUND Postoperative bleeding is a common complication after endoscopic polypectomy, particularly after endoscopic mucosal resection (EMR) of large non-pedunculated polyps, despite prophylactic clipping can reduce its occurrence. Cyanoacrylate glue has recently been proposed as a useful tool in reducing bleeding in surgery because of its adhesive and haemostatic properties. The aim of this study is to evaluate the usefulness of endoscopic application of a modified cyanoacrylate glue in the prevention of early or delayed post EMR bleeding. METHODS This is a pilot study. Inclusion criteria were patients between 18 and 75 years old affected by sessile or flat colonic polyps larger than 2 cm. Patients enrolled in the study were randomized in two groups: group A (EMR) and group B (EMR with the application of 0.3 ml of N-butyl-2-cyanoacrylate + methacryloxysulfolane-Glubran 2®). RESULTS Fifteen patients in both group A and B were enrolled. There were no intraoperative complications but haemostatic clipping was necessary in 3 patients in each group because of active bleeding. Delayed (after 24 h) bleeding occurred in two patients (13.3%) in group A requiring hospital readmission and re-do endoscopy with apposition of haemostatic clips. No case of bleeding was recorded in group B (p = 0.48). CONCLUSION The results of this pilot study suggest a potential role of local spray application of Glubran®2 in reducing post-procedural bleeding.",2020,"No case of bleeding was recorded in group B (p = 0.48). ","['Fifteen patients in both group A and B were enrolled', 'Inclusion criteria were patients between 18 and 75\xa0years old affected by sessile or flat colonic polyps larger than 2\xa0cm', 'delayed bleeding after endoscopic mucosal resection of large colorectal polyps']","['cyanoacrylate', 'Cyanoacrylate glue', 'modified cyanoacrylate glue', 'endoscopic mucosal resection (EMR', 'group A (EMR) and group B (EMR with the application of 0.3\xa0ml of N-butyl-2-cyanoacrylate + methacryloxysulfolane-Glubran 2®', 'Glubran®']","['post-procedural bleeding', 'intraoperative complications', 'hospital readmission', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}]","[{'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0014035', 'cui_str': 'Enbucrilate'}, {'cui': 'C0964648', 'cui_str': 'glubran 2'}, {'cui': 'C0964647', 'cui_str': 'glubran'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3203457', 'cui_str': 'Procedural haemorrhage'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0262898,"No case of bleeding was recorded in group B (p = 0.48). ","[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Martines', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Arcangelo', 'Initials': 'A', 'LastName': 'Picciariello', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Rigers', 'Initials': 'R', 'LastName': 'Dibra', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Trigiante', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'O Caputi', 'Initials': 'OC', 'LastName': 'Jambrenghi', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Chetta', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Donato Francesco', 'Initials': 'DF', 'LastName': 'Altomare', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy. donatofrancesco.altomare@uniba.it.'}]",International journal of colorectal disease,['10.1007/s00384-020-03678-9'] 2334,32577886,Association of antenatal vitamin B complex supplementation with neonatal vitamin B 12 status: evidence from a cluster randomized controlled trial.,"PURPOSE Evidence about the effect of maternal vitamin B 12 supplementation on offspring's vitamin B 12 status is limited. The present interventional study sought to evaluate the association of antenatal vitamin B complex supplementation with neonatal vitamin B 12 status. METHODS In an ongoing cluster randomized controlled trial conducted in three rural counties in northwest China, pregnant women < 20 weeks of gestation were randomized to three treatment groups: blank control, iron supplements, or vitamin B complex supplements. All women were administered folic acid supplements during the periconceptional period. In a sub-study, we collected cord blood samples of 331 participants from the control or vitamin B complex groups in the Xunyi county from January 2017 to December 2017. Plasma concentrations of folate, vitamin B 12 , and homocysteine were measured. Linear mixed models with a random intercept for cluster were used to compare biochemical indexes between groups after controlling for covariates. RESULTS Compared with newborns whose mothers were in the control group, newborns of the vitamin B complex-supplemented women had significantly higher cord plasma vitamin B 12 (P = 0.001) and lower homocysteine concentrations (P = 0.043). The association of antenatal vitamin B complex supplementation with cord blood vitamin B 12 concentrations appeared to be more pronounced among newborns with high folate status than those with low folate status (P interaction  = 0.060). CONCLUSIONS Maternal vitamin B complex supplementation during pregnancy was associated with better neonatal vitamin B 12 status in rural northwest China.",2020,"Compared with newborns whose mothers were in the control group, newborns of the vitamin B complex-supplemented women had significantly higher cord plasma vitamin B 12 (P = 0.001) and lower homocysteine concentrations (P = 0.043).","['three rural counties in northwest China, pregnant women\u2009<\u200920\xa0weeks of gestation', '331 participants from the control or vitamin B complex groups in the Xunyi county from January 2017 to December 2017']","['antenatal vitamin B complex supplementation with neonatal vitamin', 'maternal vitamin B 12 supplementation', 'blank control, iron supplements, or vitamin B complex supplements', 'antenatal vitamin B complex supplementation with neonatal vitamin B 12 status', 'folic acid supplements', 'Maternal vitamin B complex supplementation']","['lower homocysteine concentrations', 'cord plasma vitamin', 'Plasma concentrations of folate, vitamin B 12 , and homocysteine']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C4524017', 'cui_str': 'Vitamin B complex supplementation'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]",331.0,0.242073,"Compared with newborns whose mothers were in the control group, newborns of the vitamin B complex-supplemented women had significantly higher cord plasma vitamin B 12 (P = 0.001) and lower homocysteine concentrations (P = 0.043).","[{'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Baibing', 'Initials': 'B', 'LastName': 'Mi', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': ""Translational Medicine Center, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Danmeng', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Fangliang', 'Initials': 'F', 'LastName': 'Lei', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China. xinliu@xjtu.edu.cn.""}, {'ForeName': 'Shaonong', 'Initials': 'S', 'LastName': 'Dang', 'Affiliation': ""Department of Epidemiology and Health Statistics, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, People's Republic of China. tjdshn@xjtu.edu.cn.""}]",European journal of nutrition,['10.1007/s00394-020-02309-x'] 2335,32577921,Randomized comparative study of child and caregiver responses to three software functions added to the Japanese version of the electronic Pediatric Quality of Life Inventory (ePedsQL) questionnaire.,"BACKGROUND Patient-reported outcomes (PROs) refer to any report of the status of a patient's health condition, health behavior, or experience with healthcare directly from the patient, without interpretation of the patient's response by a clinician or any other external party. While many PROs, such as the Pediatric Quality of Life Inventory (PedsQL), were originally administered in paper-and-pencil format, these are now available as electronic versions (ePROs). Although ePROs might well have used the same structure as their paper versions, we developed an alternate ePedsQL incorporating three software functions: 1) a non-forcing non-response alert, 2) a conditional question branch of the School Functioning Scale that only displays for (pre) school children, and 3) a vertical item-by-item display for small-screen devices. This report evaluated the effect of these functions on item non-response rate, survey completion time, and user experience. METHODS All surveys were conducted via the online/computer mode. We compared the dynamic format containing the three functions with the basic format in a randomized comparative study in 2803 children and 6289 caregivers in Japan. RESULTS We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = - 4.411, p < 0.001 by generalized linear mixed model analysis). The conditional question branch had mixed effects on survey completion time depending on the respondents' age. Surprisingly, respondents rated the vertical question display for handheld devices less legible than the matrix format. Further, multigroup structural equation modelling revealed that the same configuration for both formats showed an acceptable fit (CFI 0.933, RMSEA 0.060, SRMR 0.038) but the errors of observed variables were larger for the dynamic format than the basic format. CONCLUSIONS We confirmed the robustness of the ePedsQL in different formats. The non-response rate of ePedsQL was very low even in the absence of an alert. The branch and item-by-item display were effective but unnecessary for all populations. Our findings further understanding of how humans respond to special software functions and different digital survey formats and provide new insight on how the three tested functions might be most successfully implemented.",2020,"We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = - 4.411, p < 0.001 by generalized linear mixed model analysis).",['2803 children and 6289 caregivers in Japan'],[],"['survey completion time', 'item non-response rate', 'item non-response rate, survey completion time, and user experience', 'electronic Pediatric Quality of Life Inventory (ePedsQL) questionnaire']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]",[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",2803.0,0.0234042,"We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = - 4.411, p < 0.001 by generalized linear mixed model analysis).","[{'ForeName': 'Iori', 'Initials': 'I', 'LastName': 'Sato', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan. satoi-tky@umin.ac.jp.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Sakka', 'Affiliation': 'Department of Health Quality and Outcome Research, Division of Nursing System, Global Nursing Research Center, Graduate School of Medicine, the University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Soejima', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Kita', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Kamibeppu', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.'}]",Journal of patient-reported outcomes,['10.1186/s41687-020-00213-w'] 2336,32578332,"Transurethral en bloc submucosal hydrodissection versus conventional resection for resection of non-muscle invasive bladder cancer (HYBRIDBLUE): a randomized, multicentre trial.","OBJECTIVE To determine whether transurethral en bloc submucosal hydrodissection of bladder tumours (TUEB) improves the quality of the resection compared to conventional transurethral resection (TURBT) in patients with NMIBC. PATIENTS AND METHODS A randomized, multicentre trial (HYBRIDBLUE) was conducted in a superiority design. Six German academic centres participated between 09/2012 and 08/2015. Based on literature analysis, a sample size for accurate histopathological assessment concerning muscle invasion was assumed to be feasible in 50% (P 0= 0.5) of TURBT and 80% of TUEB cases. After pre-screening of a total of 305 patients, participants were allocated to two study arms: group I: hexaminolevulinate(HAL)-guided TUEB; group II: conventional HAL-guided TURBT. The primary endpoint was the proportion of specimens which could be reliably evaluated pathologically concerning muscle-invasiveness. Secondary endpoints included rates of histopathological completeness of the resection, muscularis propria content, recurrence and complication rates. RESULTS One hundred-and-fifteen patients (TUEB: 56; TURBT: 59) were eligible for final analysis. Adequate histopathological assessment which included muscularis propria content and tumour margins (R0 vs. R1) was present in 48/56 (86%) TUEB patients compared to 37/59 (63%; p=0.0059) in the conventional group. R0 was confirmed in 30/56 TUEB-patients (57%) and 5/59 TURB-patients (9%; p<0.0001). No complications of grade III or higher were observed in both arms. At 3 and 12 months, 3 and 19 patients recurred in the TUEB group versus 7 and 11 patients in the TURBT group, respectively (p=0.33/p=0.08). CONCLUSIONS In this randomized study, TUEB was shown to be clinically safe regarding perioperative endpoints. An adequate histopathological assessment concerning muscle-invasion was significantly better assessable in the TUEB arm compared to standard TURBT. This finding inherits the clinical potential of reducing the rate of early re-resections. Yet, a larger study with RFS as primary endpoint is needed to assess the oncological efficacy between both techniques.",2020,An adequate histopathological assessment concerning muscle-invasion was significantly better assessable in the TUEB arm compared to standard TURBT.,"['non-muscle invasive bladder cancer (HYBRIDBLUE', 'Six German academic centres participated between 09/2012 and 08/2015', 'One hundred-and-fifteen patients (TUEB: 56; TURBT: 59) were eligible for final analysis', 'patients with NMIBC']","['Transurethral en bloc submucosal hydrodissection versus conventional resection', 'conventional HAL-guided TURBT', 'TUEB', 'transurethral en bloc submucosal hydrodissection of bladder tumours (TUEB', 'hexaminolevulinate(HAL)-guided TUEB', 'conventional transurethral resection (TURBT']","['rates of histopathological completeness of the resection, muscularis propria content, recurrence and complication rates', 'oncological efficacy', 'R0', 'proportion of specimens which could be reliably evaluated pathologically concerning muscle-invasiveness']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0720810', 'cui_str': 'Halotestin'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1327841', 'cui_str': 'hexyl 5-aminolevulinate'}]","[{'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}]",305.0,0.140396,An adequate histopathological assessment concerning muscle-invasion was significantly better assessable in the TUEB arm compared to standard TURBT.,"[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gakis', 'Affiliation': 'Department of Urology and Pediatric Urology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Karl', 'Affiliation': 'Department of Urology, University Hospital of Munich-Grosshadern, Munich, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bertz', 'Affiliation': 'Department of Pathology, University Hospital of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': 'Department of Urology, Caritas St. Josef Hospital, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Hans-Martin', 'Initials': 'HM', 'LastName': 'Fritsche', 'Affiliation': 'Department of Urology, Caritas St. Josef Hospital, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Department of Pathology, University Hospital of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Jokisch', 'Affiliation': 'Department of Urology, University Hospital of Munich-Grosshadern, Munich, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kempkensteffen', 'Affiliation': 'Department of Urology, Charite, University Hospital of Berlin, Berlin, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Department of Urology, Charite, University Hospital of Berlin, Berlin, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Mundhenk', 'Affiliation': 'Department of Urology, Diakonie-Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Birte-Swantje', 'Initials': 'BS', 'LastName': 'Schneevoigt', 'Affiliation': 'Department of Urology, University Hospital of Munich-Grosshadern, Munich, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Schubert', 'Affiliation': 'Department of Urology and Pediatric Urology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwentner', 'Affiliation': 'Department of Urology, Diakonie-Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wullich', 'Affiliation': 'Department of Urology and Pediatric Urology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, University Hospital of Tübingen, Tübingen, Germany.'}]",BJU international,['10.1111/bju.15150'] 2337,32578353,Rationale and design of the EMPYREAN study.,"AIMS A sodium glucose cotransporter 2 (SGLT2) inhibitor was recently found to reduce heart failure hospitalization in the EMPA-REG OUTCOME trial. We have hypothesized that autonomic nerve activity may be modulated by SGLT2 inhibition. The current study aims to investigate the impact of empagliflozin on sympathetic and parasympathetic nerve activity in patients with type 2 diabetes mellitus. METHODS AND RESULTS This ongoing study is a prospective, randomized, open-label, multicentre investigation of 134 patients with type 2 diabetes mellitus. The patients are randomly allocated to receive either empagliflozin or sitagliptin with the treatment goal of the Japan Diabetes Society guidelines. Ambulatory electrocardiographic monitoring is performed at the baseline and at 12 and 24 weeks of treatment. Analyses of heart rate variability are conducted using the MemCalc method, which is a combination of the maximum entropy method for spectral analysis and the non-linear least squares method for square analysis. The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks. CONCLUSIONS This investigation on the effect of EMPagliflozin on cardiac sYmpathetic and parasympathetic neRve activity in JapanEse pAtieNts with type 2 diabetes (EMPYREAN study) offers an important opportunity to understand the impact of SGLT2 inhibition on autonomic nerve activity in patients with type 2 diabetes.",2020,"The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks. ","['JapanEse pAtieNts with type 2 diabetes', 'patients with type 2 diabetes mellitus', 'patients with type 2 diabetes', '134 patients with type 2 diabetes mellitus']","['sodium glucose cotransporter 2', 'empagliflozin', 'empagliflozin or sitagliptin', 'EMPagliflozin', 'SGLT2 inhibition']","['cardiac sYmpathetic and parasympathetic neRve activity', 'heart failure hospitalization', 'change in the low-frequency']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0459522', 'cui_str': 'Parasympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]",134.0,0.044986,"The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks. ","[{'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Motoki', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yasuno', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shoin', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Usami', 'Affiliation': 'Department of Internal Medicine, Taigenkai Hospital, Ichinomiya, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Mitsuhisa', 'Initials': 'M', 'LastName': 'Komatsu', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Cheol', 'Initials': 'C', 'LastName': 'Son', 'Affiliation': 'Division of Endocrinology and Metabolism, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Yonemitsu', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka Red Cross Hospital, Osaka, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Hiramitsu', 'Affiliation': 'Hiramitsu Heart Clinic, Nagoya, Japan.'}, {'ForeName': 'Manako', 'Initials': 'M', 'LastName': 'Konda', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Onishi', 'Affiliation': 'Onishi Heart Clinic, Tsu, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kuwahara', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.'}]",ESC heart failure,['10.1002/ehf2.12825'] 2338,32578404,Modification of Affective Trajectory in a Positive Psychology Intervention.,"Enhancing positive affect (PA) and reducing negative affect (NA) are targets of positive psychology interventions, and well-being and positive functioning are core elements of mental health. However, the underlying temporal dynamics of these elements are unknown. This study aimed at identifying how a 42-day daily positive psychology intervention (PPI) impacts affective longitudinal dynamics compared to a control condition. This study employed an experience sampling method (self-observation diary including the Measurement of Affectivity: Valence/Activation scale, MAVA) with two non-randomised groups-a control group (n = 43) and an intervention group (n = 43)-taken from a community sample. Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI. The deactivated PA trajectory increased non-linearly across the PPI, whereas the activated PA trajectory showed a linear increase. This study suggests that PPIs change daily affective life.",2020,"Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI.",[],"['42-day daily positive psychology intervention (PPI', 'intervention group (n\xa0']","['deactivated PA trajectory', 'PPIs change daily affective life']",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",43.0,0.0211071,"Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Congard', 'Affiliation': 'Nantes University, Laboratoire de Psychologie des Pays de la Loire, LPPL, EA 4638, Nantes, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andreotti', 'Affiliation': 'University of Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Dauvier', 'Affiliation': 'Center for Research on the Psychology of Cognition, Langage and Emotion, Aix-Marseille University, Aix-en-Provence, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Le Vigouroux', 'Affiliation': 'University of Nimes, EA 7352, CHROME, Nîmes Cedex 01, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': 'University of Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Lille, France.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12206'] 2339,32569172,Unilateral versus bilateral balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures: A randomized controlled trial protocol.,"BACKGROUND It is currently controversial whether unilateral or bilateral balloon kyphoplasty (BKP) is superior in terms of postoperative outcomes in treatment of osteoporotic vertebral compression fracture (OVCF). In this context, the aim of this study was to prospectively evaluate and compare the radiographic and clinical outcomes of BKP using unilateral and bilateral approaches. METHODS This was a randomized controlled study and was approved by the Severance Institutional Review Board in our hospital. The study protocol was designed in accordance with the Declaration of Helsinki guidelines. Patients who complained of chronic back pain secondary to OVCF, which occurred in thoracic lumbar region over 6 months and met the criteria of osteoporosis were the candidates for this procedure. A total of 150 patients were randomized to undergo either unilateral or bipedicular BKP. The outcomes measures inculded pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications. RESULTS We were able to directly compare the outcomes of unilateral versus bilateral BKP and might reveal a better technique in OVCF. TRIAL REGISTRATION this study protocol was registered in Research Registry (researchregistry5543).",2020,"The outcomes measures inculded pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications. ","['150 patients', 'osteoporotic vertebral compression fractures', 'Patients who complained of chronic back pain secondary to', 'osteoporotic vertebral compression fracture (OVCF']","['unilateral or bipedicular BKP', 'BKP', 'unilateral or bilateral balloon kyphoplasty (BKP', 'OVCF', 'Unilateral versus bilateral balloon kyphoplasty']","['pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",150.0,0.115195,"The outcomes measures inculded pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications. ","[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Minimally Invasive Spine Surgery, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, No.109, Xueyuan Western Road, Wenzhou City, Zhejiang Province, P.R. China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Wenfei', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': ''}, {'ForeName': 'Qishan', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020524'] 2340,32569239,Efficiency and safety evaluation of prophylaxes for venous thrombosis after gynecological surgery.,"BACKGROUND In this study, we investigate the incidence of venous thrombosis (VT), and evaluate the effectiveness and safety of 3 major thromboprophylaxes and the potential risk factors for VT in women undergoing surgery for a gynecological malignancy. METHODS We performed a randomized controlled trial of 307 patients undergoing laparoscopic surgery for gynecological malignancies at a single institution from January 2016 to October 2017. Patients were divided into 3 groups: one receiving a half dose of low-molecular-weight heparin sodium injection (FLUXUM, Alfa Wassermann, Italy) delivered by injection, one receiving a full dose of FLUXUM, and a third group receiving an Argatroban injection. RESULTS None of the patients in our study developed a pulmonary embolism, bleeding, or infectious complications. There were no statistical differences in the rate of deep venous thrombosis (DVT) (0%, 0%, and 2.38%) and the superficial venous thromboembolism (SVT) (15.66%, 8.97%, and 18.6%) among the 3 groups. None of the patients developed symptomatic VT. The effect of treatment on alanine aminotransferase and aspartate aminotransferase differed between the groups, with a minimal effect in the Argatroban group, and all 3 methods resulted in minimal impairment of renal function. Decreased hemoglobin, elevated levels of D-dimer, and prothrombin time were closely related to thrombogenesis. CONCLUSION In conclusion, the incidence of postoperative thrombosis in gynecological malignancy among these Chinese people is not as low as we had originally presumed. Argatroban is not more effective than Parnaparin as a direct thrombin inhibitor, but it has less influence on liver function, which is beneficial for patients undergoing chemotherapy. Hemoglobin, D-dimer, and prothrombin time may be used to predict or detect thrombogenesis.",2020,"There were no statistical differences in the rate of deep venous thrombosis (DVT) (0%, 0%, and 2.38%) and the superficial venous thromboembolism (SVT) (15.66%, 8.97%, and 18.6%) among the 3 groups.","['venous thrombosis after gynecological surgery', 'women undergoing surgery for a gynecological malignancy', 'patients undergoing chemotherapy', '307 patients undergoing laparoscopic surgery for gynecological malignancies at a single institution from January 2016 to October 2017']","['low-molecular-weight heparin sodium injection (FLUXUM, Alfa Wassermann, Italy) delivered by injection, one receiving a full dose of FLUXUM, and a third group receiving an Argatroban injection', 'prophylaxes', 'Argatroban']","['pulmonary embolism, bleeding, or infectious complications', 'alanine aminotransferase and aspartate aminotransferase', 'rate of deep venous thrombosis (DVT', 'Hemoglobin, D-dimer, and prothrombin time', 'minimal impairment of renal function', 'superficial venous thromboembolism (SVT', 'symptomatic VT', 'Decreased hemoglobin, elevated levels of D-dimer, and prothrombin time']","[{'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0212082', 'cui_str': 'Fluxum'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1828121', 'cui_str': 'Injections'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4255162', 'cui_str': 'argatroban Injection'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",307.0,0.125385,"There were no statistical differences in the rate of deep venous thrombosis (DVT) (0%, 0%, and 2.38%) and the superficial venous thromboembolism (SVT) (15.66%, 8.97%, and 18.6%) among the 3 groups.","[{'ForeName': 'Ruidi', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Faridah', 'Initials': 'F', 'LastName': 'Nansubuga', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Division of Vascular Surgery, Hepatic Surgery Center, Department of Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Wencheng', 'Initials': 'W', 'LastName': 'Ding', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Kezhen', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Danhui', 'Initials': 'D', 'LastName': 'Weng', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology.'}]",Medicine,['10.1097/MD.0000000000020928'] 2341,32569258,CLEARANCE OF MYCOPLASMA GENITALIUM AND TRICHOMONAS VAGINALIS AMONG ADOLESCENTS AND YOUNG ADULTS WITH PELVIC INFLAMMATORY DISEASE: RESULTS FROM THE TECH-N STUDY.,"Current PID treatment effectively treats Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). However, coverage may be inadequate for Mycoplasma genitalium (MG)/Trichomonas vaginalis (TV) infections. We compared the longitudinal MG and TV outcomes with NG/CT outcomes for women enrolled in a longitudinal randomized controlled trial to optimize outcomes after PID. The prevalence of CT and NG were lower at 30 days and 90 days follow-up compared to the prevalence at time of diagnosis. No significant difference was observed for MG (OR 0.95, 0.86-1.04, p-0.265) and TV (OR 0.89, 0.75-1.04, p-0.146) over time for both treatment groups, showing that persistence and or reinfection with MG and TV occur more frequently than with CT or NG following treatment for PID using current national treatment guidelines.",2020,The prevalence of CT and NG were lower at 30 days and 90 days follow-up compared to the prevalence at time of diagnosis.,['VAGINALIS AMONG ADOLESCENTS AND YOUNG ADULTS WITH PELVIC INFLAMMATORY DISEASE'],['CT'],['prevalence of CT and NG'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0242172', 'cui_str': 'Female pelvic inflammatory disease'}]","[{'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}]",,0.0621644,The prevalence of CT and NG were lower at 30 days and 90 days follow-up compared to the prevalence at time of diagnosis.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Trent', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Hasiya E', 'Initials': 'HE', 'LastName': 'Yusuf', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Anders', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tabacco-Saeed', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rowell', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Huettner', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Department of Adult Emergency Medicine.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001221'] 2342,32569284,A biofeedback-enhanced therapeutic exercise video game intervention for young people with cerebral palsy: A randomized single-case experimental design feasibility study.,"IMPORTANCE/BACKGROUND Movement-controlled video games have potential to promote home-based practice of therapy activities. The success of therapy gaming interventions depends on the quality of the technology used and the presence of effective support structures. AIM This study assesses the feasibility of a novel intervention that combines a co-created gaming technology integrating evidence-based biofeedback and solution-focused coaching (SFC) strategies to support therapy engagement and efficacy at home. METHODS Following feasibility and single-case reporting standards (CONSORT and SCRIBE), this was a non-blind, randomized, multiple-baseline, AB, design. Nineteen (19) young people with cerebral palsy (8-18 years old) completed the 4-week home-based intervention in France and Canada. Participant motivations, personalized practice goals, and relevance of the intervention to daily activities were discussed in a Solution Focused Coaching-style conversation pre-, post-intervention and during weekly check-ins. Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software). Process feasibility success criteria for recruitment response, completion and adherence rates, and frequency of technical issues were established a priori. Scientific feasibility, effect size estimates and variance were determined for Body Function outcome measures: active wrist extension, grip strength and Box and Blocks Test; and for Activities and Participation measures: Assisting Hand Assessment (AHA), Canadian Occupational Performance Measure (COPM) and Self-Reported Experiences of Activity Settings (SEAS). RESULTS Recruitment response (31%) and assessment completion (84%) rates were good and 74% of participants reached self-identified practice goals. As 17% of technical issues required external support to resolve, the intervention was graded as feasible with modifications. No adverse events were reported. Moderate effects were observed in Body Function measures (active wrist extension: SMD = 1.82, 95%CI = 0.85-2.78; Grip Strength: SMD = 0.63, 95%CI = 0.65-1.91; Box and Blocks: Hedge's g = 0.58, 95%CI = -0.11-1.27) and small-moderate effects in Activities and Participation measures (AHA: Hedge's g = 0.29, 95%CI = -0.39-0.97, COPM: r = 0.60, 95%CI = 0.13-0.82, SEAS: r = 0.24, 95%CI = -0.25-0.61). CONCLUSION A definitive RCT to investigate the effectiveness of this novel intervention is warranted. Combining SFC-style coaching with high-quality biofeedback may positively engage youth in home rehabilitation to complement traditional therapy. TRIAL REGISTRATION ClinicalTrials.gov, U.S. National Library of Medicine: NCT03677193.",2020,"Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software).","['Nineteen (19) young people with cerebral palsy (8-18 years old', 'young people with cerebral palsy']","['novel intervention that combines a co-created gaming technology integrating evidence-based biofeedback and solution-focused coaching (SFC', 'single-case reporting standards (CONSORT and SCRIBE', 'biofeedback-enhanced therapeutic exercise video game intervention', 'SFC-style coaching with high-quality biofeedback', '4-week home-based intervention in France and Canada', 'video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software']","['adverse events', 'Body Function measures', 'Body Function outcome measures: active wrist extension, grip strength and Box and Blocks Test; and for Activities and Participation measures: Assisting Hand Assessment (AHA), Canadian Occupational Performance Measure (COPM) and Self-Reported Experiences of Activity Settings (SEAS']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0932629,"Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'MacIntosh', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Desailly', 'Affiliation': 'Recherche et innovation, Fondation Ellen Poidatz, Saint Fargeau-Ponthierry, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vignais', 'Affiliation': 'Complexité, Innovation, Activités Motrices et Sportives, Sciences du Sport, de la Motricité et du Mouvement Humain, Université Paris-Saclay, Orsay, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vigneron', 'Affiliation': ""Informatique, Bio-informatique et Systèmes Complexes, l'Université d'Evry Val-d'Essonne, Evry, France.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Biddiss', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}]",PloS one,['10.1371/journal.pone.0234767'] 2343,32569355,Initiation of Antiretroviral Therapy in the Hospital is Associated with Linkage to HIV Care for Persons Living with HIV and Substance Use.,"BACKGROUND Studies have demonstrated benefits of ART initiation on the day of HIV testing or at first clinical visit, regardless of CD4 count. The hospital setting is under-studied for immediate ART initiation. METHODS CTN0049, a linkage to care randomized clinical trial, enrolled 801 persons living with HIV (PLWH) and substance use disorder (SUD) from 11 hospitals across the U.S. This secondary analysis examined factors related to initiating (including re-initiating) ART in the hospital and its association with linkage to HIV care, frequency of outpatient care visits, retention in care and viral suppression. RESULTS Of 801 participants, 15% (124/801) initiated ART in the hospital, with more than two-thirds of these participants (65%;80/124) initiating ART for the first time. Time to first HIV care visit among those who initiated ART in the hospital and those who did not was 29 and 54 days, respectively, (p=0.0145). Hospital initiation of ART was associated with increased frequency of HIV outpatient care visits at 6-month (aOR=1.39, 95% CI [1.02, 1.88]) and 12-month follow-up assessments (aOR=1.53, 95% CI [1.15, 2.04]). There was no association with ART initiation in the hospital and retention in HIV care and viral suppression over a 12-month period. Participants recruited in Southern hospitals (compared to non-Southern hospitals) were less likely to initiate ART in the hospital (p<0.001). History of participation in substance use treatment was associated with greater likelihood of hospital ART initiation (p=0.008). CONCLUSIONS Previous research demonstrated benefits of immediate ART initiation, yet this approach is not widely implemented, particularly in the hospital setting with PLWH and SUD. Findings suggest starting ART in the hospital is beneficial for increasing linkage to HIV care and frequency of visits for PLWH and SUD. Implementation research should address patient and provider barriers to early ART initiation in the hospital.",2020,"History of participation in substance use treatment was associated with greater likelihood of hospital ART initiation (p=0.008). ","['Persons Living with HIV and Substance Use', '801 persons living with HIV (PLWH) and substance use disorder (SUD) from 11 hospitals across the U.S', 'Participants recruited in Southern hospitals (compared to non-Southern hospitals']",[],"['hospital and retention in HIV care and viral suppression', 'hospital ART initiation', 'frequency of HIV outpatient care visits']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]",801.0,0.176275,"History of participation in substance use treatment was associated with greater likelihood of hospital ART initiation (p=0.008). ","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': 'National Institute on Drug Abuse.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Gooden', 'Affiliation': 'Columbia University.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Daar', 'Affiliation': 'Lundquist Institute at Harbor-UCLA Medical Center.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Lucas', 'Affiliation': 'Johns Hopkins University.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'UT Southwestern.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Marsh', 'Affiliation': 'Butler Hospital.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Armstrong', 'Affiliation': 'Emory University School of Medicine.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': 'Emory University School of Medicine.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Columbia University.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa838'] 2344,32569560,Droperidol Reduces Postoperative Nausea and Vomiting and Supports the Continuation of Intravenous Patient-Controlled Analgesia with Fentanyl.,"PURPOSE To examine the impact of adding droperidol to fentanyl-based intravenous patient- controlled analgesia (IVPCA) on the discontinuation of IVPCA use due to postoperative nausea and vomiting (PONV). METHODS Patients who underwent surgeries other than abdominal surgeries and used IVPCA between April 2014 and March 2018 were selected. Patients using IVPCA with fentanyl alone were compared to patients using droperidol added to IVPCA. Patients were allocated to one of two groups depending on the drug used for IVPCA: 1) control group, fentanyl alone; 2) droperidol group, droperidol with fentanyl. The primary endpoint was the discontinuation of IVPCA due to PONV. Secondary endpoints included PONV within 48 hours after surgery, the number of antiemetics used, pain score, and adverse effects. Propensity score matching was used to control the differences in clinical features among patients. RESULTS Among the 793 patients initially enrolled in this study, 145 were excluded via propensity score matching; 364 of the remaining patients received IVPCA supplemented with droperidol. Propensity score matching showed that discontinuation of IVPCA due to PONV was significantly decreased in the droperidol group compared to the control group (P = 0.01). Further, compared with the control group, the droperidol group had reduced nausea up to 24 hours after surgery (P < 0.01), and the number of vomiting episodes and use of antiemetics decreased within 12 hours after surgery (P < 0.01). CONCLUSIONS The addition of droperidol to IVPCA is associated with a decrease in PONV, as well as the improved continuation of pain treatment with fentanyl-based IVPCA, similar to IVPCA with morphine. However, it is necessary to monitor the side effects of this treatment.",2020,"Further, compared with the control group, the droperidol group had reduced nausea up to 24 hours after surgery (P < 0.01), and the number of vomiting episodes and use of antiemetics decreased within 12 hours after surgery (P < 0.01). ","['793 patients initially enrolled in this study, 145 were excluded via propensity score matching; 364 of the remaining patients received', 'Patients who underwent surgeries other than abdominal surgeries and used IVPCA between April 2014 and March 2018 were selected']","['Droperidol', 'Fentanyl', 'droperidol', 'IVPCA with fentanyl', 'droperidol to fentanyl-based intravenous patient- controlled analgesia (IVPCA', 'IVPCA', 'IVPCA supplemented with droperidol', 'IVPCA: 1) control group, fentanyl alone; 2) droperidol group, droperidol with fentanyl', 'morphine']","['PONV within 48 hours after surgery, the number of antiemetics used, pain score, and adverse effects', 'postoperative nausea and vomiting (PONV', 'number of vomiting episodes and use of antiemetics', 'Postoperative Nausea and Vomiting', 'IVPCA due to PONV', 'nausea', 'discontinuation of IVPCA due to PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.0446875,"Further, compared with the control group, the droperidol group had reduced nausea up to 24 hours after surgery (P < 0.01), and the number of vomiting episodes and use of antiemetics decreased within 12 hours after surgery (P < 0.01). ","[{'ForeName': 'Ikkou', 'Initials': 'I', 'LastName': 'Hirata', 'Affiliation': 'Department of Pharmacy, Kameda General Hospital, Chiba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Pharmacy, Kameda General Hospital, Chiba, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Matsui', 'Affiliation': 'Clinical Research Unit, Kameda Medical Hospital/Kameda College of Health Science, Chiba, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Yoshinuma', 'Affiliation': 'Department of Anesthesiology, Kameda General Hospital, Chiba, Japan.'}, {'ForeName': 'Ryohkan', 'Initials': 'R', 'LastName': 'Funakoshi', 'Affiliation': 'Department of Pharmacy, Kameda General Hospital, Chiba, Japan.'}]","Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques",['10.18433/jpps30902'] 2345,32569567,"Are basic robotic surgical skills transferable from the simulator to the operating room? A randomized, prospective, educational study.","INTRODUCTION We aimed to assess the transferability of basic robotic skills from the simulator to the operating room while performing robotic-assisted radical prostatectomy (RARP) prostatectomy). METHODS Fourteen urology residents were randomized to two groups: group A was required to practice three sessions (nine tasks each) on the simulator, whereas group B was required to practice (same nine tasks) until they reached competency. Both groups were recorded while practicing on the da Vinci Surgical Skills Simulator (da Vinci Simulator). Both groups were then recorded while performing bladder mobilization during RARP. Senior residents from both groups were also recorded while performing urethro-vesical anastomosis during RARP. Recordings were assessed blindly using the validated GEARS tool by C-SATS. Spearman's correlation coefficient (rho) was used to assess correlation between GEARS scores from practice sessions on the da Vinci Simulator and the GEARS scores from bladder mobilization and urethro-vesical anastomosis during RARP. RESULTS There was no difference in total GEARS scores between the two groups in the operating room. Total GEARS scores for ""ring and rail 2"" and ""suture sponge"" tasks correlated with the total GEARS scores during urethro-vesical anastomosis (rho=0.86, p=0.007; rho=0.90, p=0.002, respectively). GEARS' efficiency component during ""energy and dissection"" task on the da Vinci Simulator correlated with GEARS' efficiency component during bladder mobilization (rho=0.62, p=0.03). GEARS' force sensitivity component during ""ring and rail 2"" and ""dots and needles"" tasks on the da Vinci Simulator correlated with GEARS' force sensitivity component during bladder mobilization (rho=0.58, p=0.047; rho =0.65, p=0.02, respectively). CONCLUSIONS Objective assessments of urology residents on the da Vinci Surgical Skills Simulator tasks ring and rail 2 and suture sponge correlated with their objective assessments of bladder mobilization and urethro-vesical anastomosis. Therefore, basic robotic skills could be transferred from the simulator to the operating room.",2020,"Total GEARS scores for ""ring and rail 2"" and ""suture sponge"" tasks correlated with the total GEARS scores during urethro-vesical anastomosis (rho=0.86, p=0.007; rho=0.90, p=0.002, respectively).",['Fourteen urology residents'],['robotic-assisted radical prostatectomy (RARP) prostatectomy'],"['Total GEARS scores', 'total GEARS scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0262218,"Total GEARS scores for ""ring and rail 2"" and ""suture sponge"" tasks correlated with the total GEARS scores during urethro-vesical anastomosis (rho=0.86, p=0.007; rho=0.90, p=0.002, respectively).","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Almarzouq', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Yasser A', 'Initials': 'YA', 'LastName': 'Noureldin', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Yin', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Anidjar', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bladou', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tanguay', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'Kassouf', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Armen G', 'Initials': 'AG', 'LastName': 'Aprikian', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Sero', 'Initials': 'S', 'LastName': 'Andonian', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6460'] 2346,32569643,Effect of the SafeCare© intervention on parenting outcomes among parents in child welfare systems: A cluster randomized trial.,"Child maltreatment has long-lasting negative impacts, and interventions are needed to improve caregiver's parenting skills to prevent maltreatment. This paper reports on a randomized trial comparing the SafeCare© model to services as usual (SAU) for child-welfare referred caregivers. SafeCare is an 18-session behavioral parenting program that teaches skills in positive parent-child interactions, home safety, and child health. SAU is generally unstructured and includes support, crisis management, referrals for need, and parenting education. Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers). Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment. Assessments measured positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales. Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29. Latent change score models (LCSM) using a sandwich estimator consistent with the trial design were used to examine changes in 13 outcomes. Results indicated that SafeCare had small to medium effects for improving several parenting outcomes including supporting positive child behaviors (d = 0.46), proactive parenting (d = 0.25), and two aspects of parenting stress (d = 0.28 and .30). No differential change between groups was found for other indicators, including all indicators of neglect. Parenting programs such as SafeCare offer a promising mode of intervention for child welfare systems. Scale-up of parenting programs can improve parenting, improve child outcomes, and potentially reduce maltreatment. CLINICALTRIAL.GOV REGISTRATION NUMBER: NCT02549287.",2020,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"['Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29', 'child-welfare referred caregivers', 'Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or', 'parents in child welfare systems', 'Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment']","['continue SAU', 'SafeCare']","['several parenting outcomes including supporting positive child behaviors', 'proactive parenting', 'positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales', 'parenting outcomes']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",288.0,0.0742896,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': 'Georgia State University, United States of America. Electronic address: Dwhitaker@gsu.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Self-Brown', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Osborne', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Weeks', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Reidy', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'Georgia State University, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106167'] 2347,32569671,Feasibility of surgical resection after induction EGFR-TKI therapy for N2 lung adenocarcinomas.,"BACKGROUND Prognosis of patients with stage IIIA-N2 lung adenocarcinoma is still not optimistic. The aim of this study was to evaluate safety, feasibility, and outcomes of surgery after induction epidermal growth factor receptor-tyrosine kinase inhibitor therapy in clinical trial setting. METHODS Fourteen patients with IIIA-N2 lung adenocarcinoma and EGFR mutation received erlotinib induction followed by surgery in a phase II clinical trial. Perioperative outcomes and survival results were compared with a control group of 15 patients receiving neoadjuvant chemotherapy during the same time period. RESULTS Thirteen patients showed partial response to induction while 16 patients remained stable disease. Serum carcinoembryonic antigen level in the erlotinib group was significantly higher than in the chemotherapy group before treatment, but was reduced to similar levels after induction. Operation time, blood loss, resection extents, complete resection rates, postoperative drainage, complication rates and length of hospital stay were all comparable between the two groups. Thoracoscopic resection was accomplished in 78.6% and 80.0% patients in the erlotinib and the chemotherapy groups (P=0.924). But it was higher in patients who responded to induction than those did not (92.3% vs. 68.8%, P=0.119). Resection extent greater than lobectomy and incomplete resections were only seen in stable diseases after induction. No significant difference was detected in 1-year and 3-year overall or disease-free survivals between the two groups. CONCLUSIONS Pulmonary resection is safe and feasible after induction treatment with erlotinib for stage IIIA-N2 lung adenocarcinomas. Better surgical and oncological outcomes may be expected in patients who respond to effective induction therapies.",2020,"No significant difference was detected in 1-year and 3-year overall or disease-free survivals between the two groups. ","['patients who respond to effective induction therapies', 'N2 lung adenocarcinomas', 'Fourteen patients with IIIA-N2 lung adenocarcinoma and EGFR mutation received erlotinib induction followed by surgery in a phase II clinical trial', 'patients with stage IIIA-N2 lung adenocarcinoma']","['erlotinib', 'surgical resection after induction EGFR-TKI therapy', 'neoadjuvant chemotherapy']","['1-year and 3-year overall or disease-free survivals', 'partial response to induction', 'Operation time, blood loss, resection extents, complete resection rates, postoperative drainage, complication rates and length of hospital stay', 'Serum carcinoembryonic antigen level', 'Thoracoscopic resection', 'Perioperative outcomes and survival results']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",14.0,0.026905,"No significant difference was detected in 1-year and 3-year overall or disease-free survivals between the two groups. ","[{'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""Department of thoracic surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China. Electronic address: vwtfang@hotmail.com.""}, {'ForeName': 'Tangbing', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.04.133'] 2348,32569934,Metabolic tracking of isoflavones in soybean products and biosamples from healthy adults after fermented soybean consumption.,"Fermentation may enhance the nutritional properties of foods by increasing metabolite bioactivity or bioavailability. This study explored the effect of fermentation on isoflavone bioavailability and metabolism. Isoflavone metabolites were tracked in foods and biospecimens of healthy adults after fermented soybean (FS) or non-fermented soybean (NFS) consumption in a randomized, controlled, crossover intervention study. The change in soybean isoflavones caused by fermentation resulted in faster absorption and higher bioavailability after consumption of FS. Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis. This study suggests that an isoflavone conjugate profile might be a more appropriate marker than total isoflavone levels for discriminating between the consumption of FS and NFS diets.",2020,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","['healthy adults after', 'healthy adults after fermented soybean consumption']","['fermented soybean (FS) or non-fermented soybean (NFS) consumption', 'isoflavones', 'Isoflavone metabolites']","['faster absorption and higher bioavailability', 'urinary level of total isoflavone metabolites', 'metabolite bioactivity or bioavailability', 'isoflavone bioavailability and metabolism']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0552057,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","[{'ForeName': 'Hwan-Hee', 'Initials': 'HH', 'LastName': 'Jang', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea; Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heon-Woong', 'Initials': 'HW', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Su-Yeon', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Hyeon-Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Seon-Hye', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Sung-Hyen', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gunter', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ferrari', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Scalbert', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Freisling', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Jung-Bong', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Jeong-Sook', 'Initials': 'JS', 'LastName': 'Choe', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea. Electronic address: swany@korea.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea. Electronic address: orank@ewha.ac.kr.'}]",Food chemistry,['10.1016/j.foodchem.2020.127317'] 2349,32570015,Lactobacillus rhamnosus GG and HbA1c in middle age and older adults without type 2 diabetes mellitus: A preliminary randomized study.,"BACKGROUND AND AIMS Probiotic supplementation improves glycemic control in persons with diabetes and the current study examined whether these benefits extend to healthy individuals. METHODS The current study was a 90-day placebo-controlled, double-blind, randomized clinical trial of Lactobacillus rhamnosus GG in healthy middle-aged and older adults. Fasting blood glucose and HbA1c were quantified at baseline and follow up. RESULTS ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group. CONCLUSIONS If replicated, Lactobacillus rhamnosus GG may protect against changes in glycemic control.",2020,"RESULTS ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group. ","['middle age and older adults without type 2 diabetes mellitus', 'healthy middle-aged and older adults', 'persons with diabetes']","['placebo', 'Lactobacillus rhamnosus GG', 'Lactobacillus rhamnosus GG and HbA1c', 'Probiotic supplementation']","['glycemic control', 'HbA1c values', 'Fasting blood glucose and HbA1c']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.163147,"RESULTS ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group. ","[{'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Sanborn', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA. Electronic address: vsanborn@kent.edu.'}, {'ForeName': 'M Andrea', 'Initials': 'MA', 'LastName': 'Azcarate-Peril', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, and UNC Microbiome Core, Center for Gastrointestinal Biology and Disease, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gunstad', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA; Brain Health Research Institute, Kent State University, USA.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.034'] 2350,32570059,"Effect of photobiomodulation on salivary flow and composition, xerostomia and quality of life of patients during head and neck radiotherapy in short term follow-up: A randomized controlled clinical trial.","Xerostomia and hyposalivation are frequent conditions in patients undergoing head and neck radiotherapy, which usually lead to a worsening of quality of life. This study aimed to assess whether photobiomodulation (PBM) can minimize hyposalivation, xerostomia and qualitative changes on saliva and improve quality of life in patients undergoing radiotherapy in short-term follow-up. Twenty-one patients were randomly divided into two groups: sham group (SG) and laser group (LG). A diode laser was used for intra- (660 nm, 10 J/cm 2 , 0.28 J per point, 40 mW) and extra-oral (810 nm, 25 J/cm 2 , 0.7 J per point, 40 mW) applications over the salivary glands, three times a week, during the entire radiotherapy period. In SG, the tip of the instrument was sealed with blue rubber to prevent the passage of light. Xerostomia and pH were evaluated and unstimulated and stimulated salivary flow was determined before the start of radiotherapy (T1), after the 15th session (T2), after the end of radiotherapy (T3) and 60 days after radiotherapy (T4). Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities were evaluated in stimulated saliva samples. Quality of life was assessed at times T1 and T4. Generalized estimating equations were used to assess differences in the outcome between times and groups. All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001). An increase in chloride concentrations was observed at times T3 and T4 (p < 0,05), and a reduction in amylase activity at T3 (p < .05). Unstimulated saliva pH was higher in LG than SG at T3 (p = .037). No difference between groups was noted in relation to salivary flow and composition, xerostomia or quality of life. Our results suggest that PBM may help in preserving salivary pH during radiotherapy.",2020,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","['patients undergoing head and neck', 'patients during head and neck radiotherapy in short term follow-up', 'patients undergoing radiotherapy in short-term follow-up', 'Twenty-one patients']","['radiotherapy', 'photobiomodulation (PBM', 'photobiomodulation', 'sham group (SG) and laser group (LG', 'diode laser', 'PBM']","['quality of life', 'Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities', 'Unstimulated saliva pH', 'relation to salivary flow and composition, xerostomia or quality of life', 'amylase activity', 'Quality of life', 'salivary flow and composition, xerostomia and quality of life', 'chloride concentrations', 'Xerostomia and pH', 'salivary flow, xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",21.0,0.0663906,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","[{'ForeName': 'Gabriel Campos', 'Initials': 'GC', 'LastName': 'Louzeiro', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cherubini', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Maria Antonia Zancanaro', 'Initials': 'MAZ', 'LastName': 'de Figueiredo', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fernanda Gonçalves', 'Initials': 'FG', 'LastName': 'Salum', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: fernanda.salum@pucrs.br.'}]","Journal of photochemistry and photobiology. B, Biology",['10.1016/j.jphotobiol.2020.111933'] 2351,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated. MATERIALS AND METHODS We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C. RESULTS A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant). CONCLUSIONS There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012'] 2352,32570480,A Study of the Possibility of Detecting Pediatric Mild Developmental Delay Through a Serious Game: A Randomized Cluster Trial in Cambodia.,"Although early diagnosis of developmental delay is important, there are challenges in identifying cognitive status in developing countries because of limited human and financial resources to perform diagnostic tests. Moreover, diagnosis stability of developmental delay in children using neuropsychological tests (NPTs) can remain unsettled. The aim of this study is (1) to verify the effectiveness of a serious game (DoBrain), (2) to identify existing inconsistencies between NPTs, and (3) to explore the potential of the serious game as a complement to diagnostic tools. Eligible children who had completed results of NPTs were selected (n=119/235; 116/235; case, control). With these children's scores, we performed the Mann- Whitney U test to investigate the effectiveness of the serious game by comparing the improvement of scores in both groups. Among the participants, we additionally selected a case group to identify the potential of the serious game for detecting mild developmental delay. Using the results of the CGI-S as a baseline, we defined the participants whose scores indicated more than mild illness (>=2 points) in at least one area as the suspected group. The score improvement related to memory in case group was greater than that of the control group (p<0.05). Furthermore, four of the NPTs were not inconsistent, and the sensitivity/specificity of DDST-II was the highest score considering CGI-S results as the ground truth (0.43; 0.96). Additionally, games measuring discrimination, velocity, memory, and spatial perception showed statistical significance (p<0.05). This study verifies that the serious game can help specific cognitive areas and suggests that the serious game could be used as a low-cost and unconstrained spatiotemporal alternative to NPTs.",2020,The score improvement related to memory in case group was greater than that of the control group (p<0.05).,"['Pediatric Mild Developmental Delay Through a Serious Game', 'Eligible children who had completed results of NPTs were selected (n=119/235; 116/235; case, control']",['serious game (DoBrain'],"['games measuring discrimination, velocity, memory, and spatial perception', 'mild illness']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0037744', 'cui_str': 'Space Perception'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",,0.0218095,The score improvement related to memory in case group was greater than that of the control group (p<0.05).,"[{'ForeName': 'Ho Heon', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Systems Informatics Yonsei University College of Medicine, Korea.'}, {'ForeName': 'Hong Wook', 'Initials': 'HW', 'LastName': 'Kwon', 'Affiliation': 'Department of Biomedical Systems Informatics Yonsei University College of Medicine, Korea.'}, {'ForeName': 'Sambath', 'Initials': 'S', 'LastName': 'Kao', 'Affiliation': 'National Pediatric Hospital, Cambodia.'}, {'ForeName': 'Hyuk-Sang', 'Initials': 'HS', 'LastName': 'Sohn', 'Affiliation': 'Kyung Hee University, Korea.'}, {'ForeName': 'Joohye', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Busan Presbyterian University, Korea.'}, {'ForeName': 'Yejin', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Dobrain inc., Korea.'}, {'ForeName': 'Doora', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Dobrain inc., Korea.'}, {'ForeName': 'Mirae', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Dobrain inc., Korea.'}, {'ForeName': 'Yu Rang', 'Initials': 'YR', 'LastName': 'Park', 'Affiliation': 'Department of Biomedical Systems Informatics Yonsei University College of Medicine, Korea.'}]",Studies in health technology and informatics,['10.3233/SHTI200258'] 2353,32570661,Preliminary Results from a Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Young Men.,Our study team developed the MyPEEPS Mobile App for improving HIV prevention behaviors in diverse young men. We conducted a randomized controlled trial and evaluated the preliminary outcomes in the first half (N=350) of our intended study sample. Higher self-efficacy for HIV prevention behaviors (p=0.0042) and more recent HIV tests in the past 3 months (p=0.0156) were reported by the intervention group compared to control. Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001). Preliminary results indicate that some sexual risk behaviors were reduced among the intervention group in the preliminary analytic sample.,2020,Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001).,"['diverse young men', 'Young Men']","['MyPEEPS Mobile', 'MyPEEPS Mobile App']","['HIV Prevention Behaviors', 'Numbers of condomless anal sex acts', 'receptive anal sex acts', 'sexual risk behaviors', 'HIV prevention behaviors']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0422696,Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001).,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University School of Nursing, NY, NY USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuhns', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen Lorde Community Health Center, NY, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen Lorde Community Health Center, NY, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ganzhorn', 'Affiliation': 'Columbia University School of Nursing, NY, NY USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}]",Studies in health technology and informatics,['10.3233/SHTI200444'] 2354,32570678,Strengthening Behavior and Social Functioning Among Persons with Autism Spectrum Conditions Using Artificial Intelligence and Behavioral Activation: Protocol for the Well-Being and Health for Loved onEs with ASD (WHOLE) Psychosocial Pilot Randomized Controlled Trial.,"Although a proportion of families and communities in low resource settings continue to provide care to loved ones with autism spectrum conditions, many of the affected persons remain undiagnosed and without access to proven therapies due to high treatment cost and cultural pressures, in particular. Use of conversational agents on mobile phones in combination with behavior activation home care may provide an innovative, culturally appropriate and affordable platform for strengthening behavior and social functioning outcomes, in addition to an opportunity for participation of the persons with autism spectrum conditions in the intervention development process. We aim to assess the effectiveness of an intervention that incorporates artificial intelligence conversational agent technologies and behavioral activation therapy techniques.",2020,"Use of conversational agents on mobile phones in combination with behavior activation home care may provide an innovative, culturally appropriate and affordable platform for strengthening behavior and social functioning outcomes, in addition to an opportunity for participation of the persons with autism spectrum conditions in the intervention development process.",['Persons with Autism'],['conversational agents'],['Strengthening Behavior and Social Functioning'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0422117,"Use of conversational agents on mobile phones in combination with behavior activation home care may provide an innovative, culturally appropriate and affordable platform for strengthening behavior and social functioning outcomes, in addition to an opportunity for participation of the persons with autism spectrum conditions in the intervention development process.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bowrin', 'Affiliation': 'Global Health and Health Security Doctoral Program, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Iqbal', 'Affiliation': 'Global Health and Health Security, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}]",Studies in health technology and informatics,['10.3233/SHTI200461'] 2355,32570700,Acute Effects of a Whole Body Vibration Session on the Vibration Perception Threshold in Patients with Type 2 Diabetes Mellitus.,"BACKGROUND Type 2 Diabetes Mellitus (T2DM) is a chronic disease that affects millions of people, and according to the International Diabetes Federation, 46.5% of people have undiagnosed diabetes. One of the most common complications of diabetes mellitus is loss of peripheral sensation. Whole Body Vibration (WBV) is a therapy, and it would be interesting to know if it can be considered as a training method to improve the Vibration Perception Threshold (VPT). The aim of the study is to verify whether there are really acute effects on the VPT after a WBV training session in people with T2DM. METHODS Ninety people with T2DM (56 men and 34 women) were randomly allocated to two groups: the WBV group and the placebo group. The ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device. RESULTS After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group. CONCLUSIONS Vibration perception threshold is increased after a WBV training session in people with T2DM, compared to a placebo group.",2020,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group. ","['ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device', 'Patients with Type 2 Diabetes Mellitus', 'people with T2DM', 'Ninety people with T2DM (56 men and 34 women']","['Whole Body Vibration Session', 'placebo', 'Whole Body Vibration (WBV']","['VPT', 'Vibration Perception Threshold']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",90.0,0.0272834,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group. ","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Dominguez-Muñoz', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Hernandez-Mocholi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Gordillo', 'Affiliation': 'Facultad de Administración y Negocios, Universidad Autónoma de Chile, sede Talca 3467987, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, 28943 Madrid, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Jose Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar', 'Affiliation': 'Health Economy Motricity and Education (HEME), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124356'] 2356,32570710,"Anti-Heartburn Effects of Sugar Cane Flour: A Double-Blind, Randomized, Placebo-Controlled Study.","Gastroesophageal reflux disease (GERD) affects approximately 20% of Australians. Patients suffer a burning sensation known as heartburn due to the movement of acidic stomach content into the esophagus. There is anecdotal evidence of the effectiveness of prebiotic sugarcane flour in controlling symptoms of GERD. This pilot study aimed to investigate the effectiveness of a prebiotic sugarcane flour in alleviating symptoms in medically-diagnosed GERD patients. This pilot study was a single center, double-blinded, placebo-controlled randomized trial conducted on 43 eligible participants. The intervention group ( n = 22) were randomized to receive 3 g of sugarcane flour per day, and the control group ( n = 21) received 3 g of cellulose placebo per day. Symptoms of gastroesophageal reflux disease were assessed before and after three weeks treatment using the validated Gastroesophageal Reflux Disease-Health Related Quality of Life questionnaire (GERD-HRQL). After three weeks there were significant differences in symptoms for heartburn, regurgitation, and total symptoms scores ( p < 0.05) between the sugarcane flour and placebo. Mean GERD-HRQL scores increased in the placebo group for regurgitation (mean increase 1.7; 95% CI 0.23 to 3.2; p = 0.015) and total symptom scores (2.9; 95% CI 0.26 to 5.7; p = 0.033). In contrast, there were significant reductions in heartburn (mean decrease -2.2; 95% CI -4.2 to -0.14; p = 0.037) and total symptom scores (-3.7; 95% CI -7.2 to -0.11; p = 0.044) in the intervention group. This pilot study has shown significant positive effects of sugarcane flour in the reduction of GERD symptoms, and a larger randomized controlled trial is warranted.",2020,"After three weeks there were significant differences in symptoms for heartburn, regurgitation, and total symptoms scores ( p < 0.05) between the sugarcane flour and placebo.","['medically-diagnosed GERD patients', '43 eligible participants']","['Placebo', 'prebiotic sugarcane flour', 'Sugar Cane Flour', 'sugarcane flour', '3 g of cellulose placebo', 'placebo']","['Symptoms of gastroesophageal reflux disease', 'symptoms for heartburn, regurgitation, and total symptoms scores', 'Mean GERD-HRQL scores', 'validated Gastroesophageal Reflux Disease-Health Related Quality of Life questionnaire (GERD-HRQL', 'total symptom scores', 'Gastroesophageal reflux disease (GERD', 'heartburn']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0997177', 'cui_str': 'Sugarcane'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",43.0,0.58222,"After three weeks there were significant differences in symptoms for heartburn, regurgitation, and total symptoms scores ( p < 0.05) between the sugarcane flour and placebo.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Beckett', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, TAS 7250, Australia.'}, {'ForeName': 'Neeraj K', 'Initials': 'NK', 'LastName': 'Singh', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, TAS 7250, Australia.'}, {'ForeName': 'Jehan', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'First Point Healthcare, Launceston, TAS 7250, Australia.'}, {'ForeName': 'Krishnakumar', 'Initials': 'K', 'LastName': 'Kalpurath', 'Affiliation': 'Mersey Community Hospital, Latrobe, TAS 7307, Australia.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': 'KFSU Pty Ltd., Ayr, QLD 4807, Australia.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Stanley', 'Affiliation': 'Centre for Food Innovation, Tasmanian Institute of Agriculture, University of Tasmania, Launceston 7250, Australia.'}, {'ForeName': 'Rajaraman D', 'Initials': 'RD', 'LastName': 'Eri', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, TAS 7250, Australia.'}]",Nutrients,['10.3390/nu12061813'] 2357,32578778,Comparison of the effect of ultrasound-guided thoracic paravertebral nerve block and intercostal nerve block for video-assisted thoracic surgery under spontaneous-ventilating anesthesia.,"OBJECTIVE The aim of the current study was to compare the efficacy of two different techniques for blocking chest nerves during video-assisted thoracic surgery (VATS) under spontaneous-ventilating anesthesia. METHODS One hundred patients were recruited in this study and divided into two groups. The first, P group, underwent the TPVB approach; the second, I group, underwent the ICNB approach. Then, the rate of clinical efficacy, duration of the block procedure, and its complications were recorded for comparison of the effect of the two approaches. RESULTS No difference was found in the clinical effect of chest nerve blocks between the two groups. Two patients in the ICNB group were converted to general anesthesia due to severe mediastinal flutter (grade three). The number of patients who had grade one mediastinal flutter in the TPVB group was significantly higher than in the ICNB group. Vascular puncture was detected in four patients in the ICNB group and in one patient in the TPVB group. No other complications were observed. CONCLUSIONS No difference was found regarding the clinical efficacy in the two groups. However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia. Additionally, vascular puncture should receive more attention.",2020,"However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia.",['One hundred patients'],"['ICNB', 'ultrasound-guided thoracic paravertebral nerve block and intercostal nerve block for video-assisted thoracic surgery under spontaneous-ventilating anesthesia', 'video-assisted thoracic surgery (VATS']","['clinical effect of chest nerve blocks', 'clinical efficacy', 'rate of clinical efficacy, duration of the block procedure, and its complications', 'grade one mediastinal flutter', 'Vascular puncture', 'general anesthesia due to severe mediastinal flutter']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",100.0,0.0389686,"However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia.","[{'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Weibao', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Donghua', 'Initials': 'D', 'LastName': 'Shao', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.4.452'] 2358,32578800,Electric toothbrush for biofilm control in individuals with Down syndrome: a crossover randomized clinical trial.,"Poor oral hygiene seems to be the norm in children and teenagers with Down Syndrome (DS). Advances in design and types of toothbrushes may improve biofilm control. This randomized, single-blind, crossover clinical trial evaluated the effectiveness of electric toothbrushes regarding mechanical control of biofilm in children and teenagers with DS and their cooperation. Twenty-nine participants with DS, aged 6 to 14 years, used both types of toothbrushes: electric (ET) and manual (MT). The order of use of the different types of toothbrushes was randomly defined, including a 7-day period with each type with 7-day washout period in between. The Turesky-Quigley-Hein biofilm index was used before and after brushing to assess the effectiveness of the technique. Frankl's behavioral scale was used during toothbrushing to assess the participants' cooperation. Paired T-test, Mann Whitney, Chi-square, and Fisher's Exact tests were applied, with a significance level of 5%. The quantity of dental biofilm was significantly reduced after both brushing techniques (p < 0.001). However, no significant difference was found in total biofilm (ET: 0.73 ± 0.36; MT: 0.73 ± 0.34; p = 0.985) or % biofilm reduction (ET: 72.22%; MT: 70.96%; p = 0.762) after brushing between techniques or in % biofilm reduction between toothbrushes of age groups (6 -9 years, p = 0.919; 10-14 years, p = 0.671). Participants showed similar cooperation level with the two types of toothbrush (p = 1.000). The use of electric or manual toothbrush had no effect on the quantity of dental biofilm removed in children and teenagers with DS, nor did it influence their cooperation during the procedure.",2020,"The use of electric or manual toothbrush had no effect on the quantity of dental biofilm removed in children and teenagers with DS, nor did it influence their cooperation during the procedure.","['children and teenagers with DS', 'individuals with Down syndrome', 'Twenty-nine participants with DS, aged 6 to 14 years, used both types of', 'children and teenagers with Down Syndrome (DS', 'children and teenagers with DS and their cooperation']","['Electric toothbrush', 'electric toothbrushes', 'toothbrushes: electric (ET) and manual (MT', 'electric or manual toothbrush']","['quantity of dental biofilm', 'total biofilm', ""Frankl's behavioral scale"", 'cooperation level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",29.0,0.0316669,"The use of electric or manual toothbrush had no effect on the quantity of dental biofilm removed in children and teenagers with DS, nor did it influence their cooperation during the procedure.","[{'ForeName': 'Aryvelto Miranda', 'Initials': 'AM', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Postgraduation Program in Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Luís Fernando Bandeira', 'Initials': 'LFB', 'LastName': 'Miranda', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Department of Restorative Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Ana Sara Matos', 'Initials': 'ASM', 'LastName': 'AraÚjo', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Department of Restorative Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Raimundo Rosendo', 'Initials': 'RR', 'LastName': 'Prado JÚnior', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Postgraduation Program in Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Regina Ferraz', 'Initials': 'RF', 'LastName': 'Mendes', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Postgraduation Program in Dentistry, Teresina, PI, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0057'] 2359,32578813,Metabolic and Inflammatory Benefits of Reducing Preoperative Fasting Time in Pediatric Surgery.,"OBJECTIVE To investigate the metabolic/inflammatory impact of reducing the preoperative fasting time in preschool children. METHODS Forty children were randomly assigned to a fasting group (absolute fasting after 00:00) and a carbohydrate (CHO) group (allowed to ingest, two hours before surgery, a carbohydrate-rich beverage). Blood samples were collected right before and after surgery to quantify the levels of albumin, interleukin-6, glucose, insulin, C-reactive protein and to calculate insulin resistance by the HOMA-IR index. RESULTS Preoperative fasting time in the CHO group were shorter than in the fasting group (2.49h vs. 11.24h, p <0.001). Pre- and post-surgical CRP levels were significantly lower in the CHO group (p = 0.05 and p = 0.02, respectively). The preoperative CRP/albumin ratios in the CHO group were lower than in the fasting group (p = 0.03). Four patients (21%) in the fasting group but none in the CHO group were hyperglycemic before surgery (p = 0.04). The two groups had similar levels of albumin, interleukin-6, insulin and HOMA index. There were no adverse events. CONCLUSION Reducing the preoperative fasting time with carbohydrate-rich beverages improves the perioperative metabolic and inflammatory responses of preschool children undergoing inguinal hernia surgery.",2020,The preoperative CRP/albumin ratios in the CHO group were lower than in the fasting group (p = 0.03).,"['Forty children', 'Pediatric Surgery', 'preschool children undergoing inguinal hernia surgery', 'preschool children']","['fasting group (absolute fasting after 00:00) and a carbohydrate (CHO', 'carbohydrate-rich beverages']","['Pre- and post-surgical CRP levels', 'preoperative CRP/albumin ratios', 'Preoperative fasting time', 'similar levels of albumin, interleukin-6, insulin and HOMA index', 'levels of albumin, interleukin-6, glucose, insulin, C-reactive protein and to calculate insulin resistance by the HOMA-IR index', 'perioperative metabolic and inflammatory responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",40.0,0.0213286,The preoperative CRP/albumin ratios in the CHO group were lower than in the fasting group (p = 0.03).,"[{'ForeName': 'Carlos Augusto Leite de Barros', 'Initials': 'CALB', 'LastName': 'Carvalho', 'Affiliation': 'Santa Casa de Misericórdia de Cuiabá-MT, Cirurgia Pediátrica - Cuiabá - MT - Brasil.'}, {'ForeName': 'Augusto Aurélio de', 'Initials': 'AA', 'LastName': 'Carvalho', 'Affiliation': 'Santa Casa de Misericórdia de Cuiabá-MT, Cirurgia Pediátrica - Cuiabá - MT - Brasil.'}, {'ForeName': ""Antônio D'Oliveira Gonçalves"", 'Initials': 'ADG', 'LastName': 'Preza', 'Affiliation': 'Santa Casa de Misericórdia de Cuiabá-MT, Cirurgia Pediátrica - Cuiabá - MT - Brasil.'}, {'ForeName': 'Paulo Luiz Batista', 'Initials': 'PLB', 'LastName': 'Nogueira', 'Affiliation': 'Centro Universitário de Várzea Grande, Faculdade de Medicina - Várzea Grande - MT - Brasil.'}, {'ForeName': 'Katia Bezerra Veloso', 'Initials': 'KBV', 'LastName': 'Mendes', 'Affiliation': 'SEDARE Anestesiologia, Anestesiologia - Cuiabá - MT - Brasil.'}, {'ForeName': 'Diana Borges', 'Initials': 'DB', 'LastName': 'Dock-Nascimento', 'Affiliation': 'Universidade Federal de Mato Grosso, Faculdade de Nutrição - Cuiabá - MT - Brasil.'}, {'ForeName': 'José Eduardo', 'Initials': 'JE', 'LastName': 'Aguilar-Nascimento', 'Affiliation': 'Centro Universitário de Várzea Grande, Faculdade de Medicina - Várzea Grande - MT - Brasil.'}]",Revista do Colegio Brasileiro de Cirurgioes,['10.1590/0100-6991e-20202353'] 2360,32578850,A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial.,"AIM We tested the hypothesis that dapagliflozin may regress left ventricular hypertrophy (LVH) in people with type 2 diabetes (T2D). METHODS AND RESULTS We randomly assigned 66 people (mean age 67 ± 7 years, 38 males) with T2D, LVH, and controlled blood pressure (BP) to receive dapagliflozin 10 mg once daily or placebo for 12 months. Primary endpoint was change in absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging. In the intention-to-treat analysis, dapagliflozin significantly reduced LVM compared with placebo with an absolute mean change of -2.82g [95% confidence interval (CI): -5.13 to -0.51, P = 0.018]. Additional sensitivity analysis adjusting for baseline LVM, baseline BP, weight, and systolic BP change showed the LVM change to remain statistically significant (mean change -2.92g; 95% CI: -5.45 to -0.38, P = 0.025). Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h systolic BP (P = 0.012), nocturnal systolic BP (P = 0.017), body weight (P < 0.001), visceral adipose tissue (VAT) (P < 0.001), subcutaneous adipose tissue (SCAT) (P = 0.001), insulin resistance, Homeostatic Model Assessment of Insulin Resistance (P = 0.017), and high-sensitivity C-reactive protein (hsCRP) (P = 0.049). CONCLUSION Dapagliflozin treatment significantly reduced LVM in people with T2D and LVH. This reduction in LVM was accompanied by reductions in systolic BP, body weight, visceral and SCAT, insulin resistance, and hsCRP. The regression of LVM suggests dapagliflozin can initiate reverse remodelling and changes in left ventricular structure that may partly contribute to the cardio-protective effects of dapagliflozin. CLINICALTRIALS.GOV IDENTIFIER NCT02956811.",2020,"Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h systolic BP (P = 0.012), nocturnal systolic BP (P = 0.017), body weight (P < 0.001), visceral adipose tissue (VAT) (P < 0.001), subcutaneous adipose tissue (SCAT) (P = 0.001), insulin resistance, Homeostatic Model Assessment of Insulin Resistance (P = 0.017), and high-sensitivity C-reactive protein (hsCRP) (P = 0.049). ","['66 people (mean age 67 ± 7 years, 38 males) with T2D, LVH, and controlled blood pressure (BP) to receive', 'people with type 2 diabetes (T2D', 'people with type two diabetes']","['placebo', 'Dapagliflozin', 'dapagliflozin', 'dapagliflozin 10 mg once daily or placebo']","['ambulatory 24-h systolic BP', 'subcutaneous adipose tissue (SCAT', 'systolic BP, body weight, visceral and SCAT, insulin resistance, and hsCRP', 'body weight', 'LVM', 'baseline LVM, baseline BP, weight, and systolic BP change', 'left ventricular hypertrophy (LVH', 'absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging', 'nocturnal systolic BP', 'left ventricular hypertrophy', 'visceral adipose tissue (VAT', 'insulin resistance, Homeostatic Model Assessment of Insulin Resistance', 'high-sensitivity C-reactive protein (hsCRP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0270500', 'cui_str': 'Coprophilia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",66.0,0.50898,"Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h systolic BP (P = 0.012), nocturnal systolic BP (P = 0.017), body weight (P < 0.001), visceral adipose tissue (VAT) (P < 0.001), subcutaneous adipose tissue (SCAT) (P = 0.001), insulin resistance, Homeostatic Model Assessment of Insulin Resistance (P = 0.017), and high-sensitivity C-reactive protein (hsCRP) (P = 0.049). ","[{'ForeName': 'Alexander J M', 'Initials': 'AJM', 'LastName': 'Brown', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital & Medical School, Dundee DD1 9SY, UK.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'McCrimmon', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'John Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Department of Radiology, Ninewells Hospital & Medical School, Dundee DD1 9SY, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular & Clinical Medicine, School of Medicine, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa419'] 2361,32579152,Relationship between genetic knowledge and familial communication of CRC risk and intent to communicate CRCP genetic information: insights from FamilyTalk eMERGE III.,"Successful translation of genetic information into patient-centered care and improved outcomes depends, at least in part, on patients' genetic knowledge. Although genetic knowledge is believed to be an important facilitator of familial communication of genetic risk information, empirical evidence of this association is lacking. We examined whether genetic knowledge was related to frequency of current familial communication about colorectal cancer and polyp (CRCP) risk, and future intention to share CRCP-related genomic test results with family members in a clinical sample of patients. We recruited 189 patients eligible for clinical CRCP sequencing to the eMERGE III FamilyTalk randomized controlled trial and surveyed them about genetic knowledge and familial communication at baseline. Participants were primarily Caucasian, 47% male, average age of 68 years, mostly well educated, and with high-income levels. Genetic knowledge was positively associated with future-intended familial communication of genetic information (odds ratio = 1.11, 95% confidence interval: 1.02-1.23), but not associated with current communication of CRC risk (β = 0.01, p = .58). Greater current communication of CRC risk was associated with better family functioning (β = 0.04, p = 8.2e-5). Participants' genetic knowledge in this study was minimally associated with their intended familial communication of genetic information. Although participants have good intentions of communication, family-level factors may hinder actual follow through of these intentions. Continued focus on improving proband's genetic knowledge coupled with interventions to overcome family-level barriers to communication may be needed to improve familial communication rates.",2020,"Genetic knowledge was positively associated with future-intended familial communication of genetic information (odds ratio = 1.11, 95% confidence interval: 1.02-1.23), but not associated with current communication of CRC risk (β = 0.01, p = .58).","['Participants were primarily Caucasian, 47% male, average age of 68 years, mostly well educated, and with high-income levels', '189 patients eligible for clinical CRCP sequencing to the eMERGE III FamilyTalk randomized controlled trial and surveyed them about genetic knowledge and familial communication at baseline']",[],['Greater current communication of CRC risk'],"[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524327', 'cui_str': 'Well educated'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",189.0,0.0278024,"Genetic knowledge was positively associated with future-intended familial communication of genetic information (odds ratio = 1.11, 95% confidence interval: 1.02-1.23), but not associated with current communication of CRC risk (β = 0.01, p = .58).","[{'ForeName': 'Sukh', 'Initials': 'S', 'LastName': 'Makhnoon', 'Affiliation': 'Department of Behavioral Science, UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Bowen', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Shirts', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Hendrika W', 'Initials': 'HW', 'LastName': 'Meischke', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Larson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Ralston', 'Affiliation': 'Genetic Services, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Leppig', 'Affiliation': 'Genetic Services, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Crosslin', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Veenstra', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'Departments of Medicine (Medical Genetics) and Genome Sciences, University of Washington Medical Center, Seattle, WA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa054'] 2362,32579195,Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial.,"Importance Severe acute respiratory syndrome coronavirus 2 infection has evolved into a global pandemic. Low-dose colchicine combines anti-inflammatory action with a favorable safety profile. Objective To evaluate the effect of treatment with colchicine on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19). Design, Setting, and Participants In this prospective, open-label, randomized clinical trial (the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention), 105 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from April 3 to April 27, 2020, to either standard medical treatment or colchicine with standard medical treatment. The study took place in 16 tertiary hospitals in Greece. Intervention Colchicine administration (1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg twice daily) with standard medical treatment for as long as 3 weeks. Main Outcomes and Measures Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death. Secondary end points were (1) the percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events. The primary efficacy analysis was performed on an intention-to-treat basis. Results A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the colchicine group. Median (interquartile range) peak high-sensitivity cardiac troponin values were 0.0112 (0.0043-0.0093) ng/mL in the control group and 0.008 (0.004-0.0135) ng/mL in the colchicine group (P = .34). Median (interquartile range) maximum C-reactive protein levels were 4.5 (1.4-8.9) mg/dL vs 3.1 (0.8-9.8) mg/dL (P = .73), respectively. The clinical primary end point rate was 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = .02). Mean (SD) event-free survival time was 18.6 (0.83) days the in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03). Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). Conclusions and Relevance In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration. There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels. These findings should be interpreted with caution. Trial Registration ClinicalTrials.gov Identifier: NCT04326790.",2020,"Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). ","['A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the', 'patients hospitalized with coronavirus disease 2019 (COVID-19', '105 patients hospitalized with COVID-19', 'Patients Hospitalized With Coronavirus Disease 2019', '16 tertiary hospitals in Greece']","['Colchicine', 'standard medical treatment or colchicine with standard medical treatment', 'Colchicine vs Standard Care', 'colchicine']","['time to clinical deterioration', 'diarrhea', 'Adverse events', 'high-sensitivity cardiac troponin or C-reactive protein levels', 'Mean (SD) event-free survival time', 'Median (interquartile range) maximum C-reactive protein levels', 'Median (interquartile range) peak high-sensitivity cardiac troponin values', 'maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death', 'intention-to-treat basis', 'percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205404', 'cui_str': 'Serious'}]",105.0,0.277987,"Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). ","[{'ForeName': 'Spyridon G', 'Initials': 'SG', 'LastName': 'Deftereos', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannopoulos', 'Affiliation': 'Department of Cardiology, G. Gennimatas General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Vrachatis', 'Affiliation': 'Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano-Milan, Italy.'}, {'ForeName': 'Gerasimos D', 'Initials': 'GD', 'LastName': 'Siasos', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sotiria G', 'Initials': 'SG', 'LastName': 'Giotaki', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Gargalianos', 'Affiliation': 'Athens Medical Center, Athens, Greece.'}, {'ForeName': 'Simeon', 'Initials': 'S', 'LastName': 'Metallidis', 'Affiliation': 'First Department of Internal Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sianos', 'Affiliation': 'First Department of Cardiology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Baltagiannis', 'Affiliation': 'Department of Internal Medicine, General Hospital of Kastoria, Kastoria, Greece.'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Panagopoulos', 'Affiliation': 'Second Department of Internal Medicine, General Hospital of Alexandroupoli, Democritus University of Thrace, Alexandroupoli, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Dolianitis', 'Affiliation': 'Department of Internal Medicine, Mpodosakio General Hospital of Ptolemaida, Ptolemaida, Greece.'}, {'ForeName': 'Efthalia', 'Initials': 'E', 'LastName': 'Randou', 'Affiliation': 'Department of Internal Medicine, General Hospital of Kozani, Kozani, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': 'Third Department of Internal Medicine, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Kotanidou', 'Affiliation': 'First Intensive Care Unit, General Hospital Evangelismos, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos G', 'Initials': 'NG', 'LastName': 'Koulouris', 'Affiliation': 'First Department of Pneumonology, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Milionis', 'Affiliation': 'First Department of Internal Medicine, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Sipsas', 'Affiliation': 'Infectious Diseases Unit, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Gogos', 'Affiliation': 'Internal Medicine Department, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tsoukalas', 'Affiliation': 'Fourth Department of Pneumonology, General Hospital Sotiria, Athens, Greece.'}, {'ForeName': 'Christoforos D', 'Initials': 'CD', 'LastName': 'Olympios', 'Affiliation': 'Department of Cardiology, General Hospital of Elefsina Thriasio, Elefsina, Greece.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Tsagalou', 'Affiliation': 'Therapeutics Department, Alexandra Hospital, Athens, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Migdalis', 'Affiliation': 'Second Medical Department, NIMTS Hospital, Athens, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Gerakari', 'Affiliation': 'Department of Internal Medicine, General Hospital of West Attica Agia Varvara, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Angelidis', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Pericles', 'Initials': 'P', 'LastName': 'Davlouros', 'Affiliation': 'Department of Cardiology, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hahalis', 'Affiliation': 'Department of Cardiology, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Kanonidis', 'Affiliation': 'Second Department of Cardiology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Demosthenes', 'Initials': 'D', 'LastName': 'Katritsis', 'Affiliation': 'Third Department of Cardiology, Hygeia Hospital, Athens, Greece.'}, {'ForeName': 'Theofilos', 'Initials': 'T', 'LastName': 'Kolettis', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Antonios S', 'Initials': 'AS', 'LastName': 'Manolis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Michalis', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Katerina K', 'Initials': 'KK', 'LastName': 'Naka', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Vlasios N', 'Initials': 'VN', 'LastName': 'Pyrgakis', 'Affiliation': 'Department of Cardiology, G. Gennimatas General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Konstantinos P', 'Initials': 'KP', 'LastName': 'Toutouzas', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Filippos', 'Initials': 'F', 'LastName': 'Triposkiadis', 'Affiliation': 'Department of Cardiology, University General Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsioufis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Vavouranakis', 'Affiliation': 'Third Department of Cardiology, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martinèz-Dolz', 'Affiliation': 'Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reimers', 'Affiliation': 'Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano-Milan, Italy.'}, {'ForeName': 'Giulio G', 'Initials': 'GG', 'LastName': 'Stefanini', 'Affiliation': 'Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano-Milan, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cleman', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goudevenos', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsiodras', 'Affiliation': 'Fourth Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Christodoulos', 'Initials': 'C', 'LastName': 'Stefanadis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.13136'] 2363,32579229,Teaching Newly Licensed RNs to Build an Interprofessional Collaborative Practice.,"BACKGROUND Recommendations for health care institutions to evaluate the effectiveness of nurse internship programs in facilitating the acquisition of an interprofessional collaborative practice exist. This pilot project explored the effectiveness of simulation-based education compared with online education on inter-professional socialization and collaboration among newly licensed RNs transitioning into medical-surgical practice. METHOD An experimental repeated-measures design examined professional nursing practice attributes of values, attitudes, and behaviors along with interprofessional collaboration core competencies. Participants (n = 29) were randomized into either a control group (nurse internship with online interprofessional education) or an experimental group (nurse internship with simulation-based interprofessional education). RESULTS Changes in interprofessional role socialization and valuing occurred as measured by the Interprofessional Socialization and Valuing Scale. Interprofessional Collaborative Competency Attainment Survey data demonstrated a change in interprofessional collaboration. CONCLUSION Findings support how educators in the health care setting can consider the integration of interprofessional education teaching methodologies into nurse internship programs. [J Contin Educ Nurs. 2020;51(7):331-337.].",2020,"This pilot project explored the effectiveness of simulation-based education compared with online education on inter-professional socialization and collaboration among newly licensed RNs transitioning into medical-surgical practice. ",['Participants (n = 29'],"['simulation-based education compared with online education', 'control group (nurse internship with online interprofessional education) or an experimental group (nurse internship with simulation-based interprofessional education']",['Interprofessional Socialization and Valuing Scale'],[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0237690', 'cui_str': 'Internship'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",29.0,0.0219938,"This pilot project explored the effectiveness of simulation-based education compared with online education on inter-professional socialization and collaboration among newly licensed RNs transitioning into medical-surgical practice. ","[{'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Rossler', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hardin', 'Affiliation': ''}]",Journal of continuing education in nursing,['10.3928/00220124-20200611-09'] 2364,32570775,Flavonoid-Rich Orange Juice Intake and Altered Gut Microbiome in Young Adults with Depressive Symptom: A Randomized Controlled Study.,"Depression is not just a general mental health problem but a serious medical illness that can worsen without treatment. The gut microbiome plays a major role in the two-way communication system between the intestines and brain. The current study examined the effects of flavonoids on depression by observing the changes in the gut microbiome and depressive symptoms of young participants consuming flavonoid-rich orange juice. The depressive symptom was assessed using the Center for Epidemiological Studies Depression Scale (CES-D), a psychiatric screening tool used to detect preexisting mental disorders. The study population was randomly divided into two groups: the flavonoid-rich orange juice (FR) and an equicaloric flavonoid-low orange cordial (FL) group. For 8 weeks, participants consumed FR (serving a daily 380 mL, 600 ± 5.4 mg flavonoids) or FL (serving a daily 380 mL, 108 ± 2.6 mg flavonoids). In total, 80 fecal samples from 40 participants (mean age, 21.83 years) were sequenced. Regarding depression, we observed positive correlations between brain-derived neurotrophic factor (BDNF) and the Lachnospiraceae family ( Lachnospiraceae_uc and Murimonas ) before flavonoid orange juice treatment. Most notably, the abundance of the Lachnospiraceae family ( Lachnospiraceae_uc , Eubacterium_g4 , Roseburia_uc , Coprococcus_g2_uc , Agathobacter_uc ) increased after FR treatment compared to that after FL treatment. We also validated the presence of unclassified Lachnospiraceae through sensitive real-time quantitative polymerase chain reaction using stool samples from participants before and after flavonoid treatment. Our results provide novel interventional evidence that alteration in the microbiome due to flavonoid treatment is related to a potential improvement in depression in young adults.",2020,"Most notably, the abundance of the Lachnospiraceae family ( Lachnospiraceae_uc , Eubacterium_g4 , Roseburia_uc , Coprococcus_g2_uc , Agathobacter_uc ) increased after FR treatment compared to that after FL treatment.","['young participants consuming flavonoid-rich orange juice', 'young adults', 'Young Adults with Depressive Symptom', 'In total, 80 fecal samples from 40 participants (mean age, 21.83 years) were sequenced']","['FL', 'flavonoid-rich orange juice (FR) and an equicaloric flavonoid-low orange cordial (FL) group', 'flavonoids', 'Flavonoid-Rich Orange Juice Intake']","['abundance of the Lachnospiraceae family ( Lachnospiraceae_uc , Eubacterium_g4 , Roseburia_uc , Coprococcus_g2_uc , Agathobacter_uc ', 'depressive symptom']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0325205,"Most notably, the abundance of the Lachnospiraceae family ( Lachnospiraceae_uc , Eubacterium_g4 , Roseburia_uc , Coprococcus_g2_uc , Agathobacter_uc ) increased after FR treatment compared to that after FL treatment.","[{'ForeName': 'Miey', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Korea.'}, {'ForeName': 'Jihee', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Gyeonggi-do 13120, Korea.'}]",Nutrients,['10.3390/nu12061815'] 2365,32570811,"Leucine-Enriched Protein Supplementation Increases Lean Body Mass in Healthy Korean Adults Aged 50 Years and Older: A Randomized, Double-Blind, Placebo-Controlled Trial.","Early prevention of sarcopenia could be an important strategy for muscle retention, but most studies have focused on subjects aged 65 or older. Therefore, in this study we investigated the effects of leucine-enriched protein supplementation on muscle condition in a sample including late middle-aged adults. A 12-week intervention was performed for 120 healthy community-dwelling adults by providing either leucine-enriched protein supplement [leucine 3 g, protein mixture (casein 50% + whey 40% + soy 10%) 17 g, vitamin D 800IU (20 µg), calcium 300 mg, fat 1.1 g, carbohydrate 2.5 g] or isocaloric carbohydrate supplement twice per day. Appendicular skeletal muscle mass index (ASMI) and lean body mass (LBM) were measured by dual-energy X-ray absorptiometry. A total of 111 participants completed the study, with a dropout rate of 9.2%. LBM normalized by height and body weight (LBM/Wt) was significantly increased ( p < 0.001) in the intervention group (0 wk: 633.9 ± 8.5 vs. 12 wk 636.9 ± 8.4 in the intervention group; 0 wk: 638.6 ± 8.3 vs. 12 wk: 632.9 ± 8.1 in the control group). In subgroup analyses, significant differences remained only in subjects between 50 and 64 years of age. We concluded that leucine-enriched protein supplementation can have beneficial effects by preventing muscle loss, mainly for late middle-aged adults.",2020,LBM normalized by height and body weight (LBM/Wt) was significantly increased ( p < 0.001) in the intervention group (0 wk: 633.9 ± 8.5 vs. 12 wk 636.9 ± 8.4 in the intervention group; 0 wk: 638.6 ± 8.3 vs. 12 wk: 632.9 ± 8.1 in the control group).,"['120 healthy community-dwelling adults by providing either', 'subjects aged 65 or older', 'A total of 111 participants completed the study, with a dropout rate of 9.2', 'Aged 50 Years and Older', 'muscle condition in a sample including late middle-aged adults', 'late middle-aged adults', 'Healthy Korean Adults']","['Placebo', 'leucine-enriched protein supplement [leucine 3 g, protein mixture (casein 50% + whey 40% + soy 10', 'Leucine-Enriched Protein Supplementation', 'vitamin D 800IU (20 µg), calcium 300 mg, fat 1.1 g, carbohydrate 2.5 g] or isocaloric carbohydrate supplement', 'leucine-enriched protein supplementation']","['Appendicular skeletal muscle mass index (ASMI) and lean body mass (LBM', 'Lean Body Mass', 'LBM normalized by height and body weight (LBM/Wt']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",120.0,0.291926,LBM normalized by height and body weight (LBM/Wt) was significantly increased ( p < 0.001) in the intervention group (0 wk: 633.9 ± 8.5 vs. 12 wk 636.9 ± 8.4 in the intervention group; 0 wk: 638.6 ± 8.3 vs. 12 wk: 632.9 ± 8.1 in the control group).,"[{'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yong-in 17104, Korea.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yong-in 17104, Korea.'}, {'ForeName': 'Yong Jun', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Yunhwan', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine and Public Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Yun', 'Affiliation': 'Department of Preventive Medicine and Public Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Seok Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Health & Nutrition R&D Group, Maeil Dairies Co., Ltd., Pyeongtaek-si 17714, Korea.'}, {'ForeName': 'Hyoung Su', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Health & Nutrition R&D Group, Maeil Dairies Co., Ltd., Pyeongtaek-si 17714, Korea.'}, {'ForeName': 'Yoon-Sok', 'Initials': 'YS', 'LastName': 'Chung', 'Affiliation': 'Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Yoo Kyoung', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yong-in 17104, Korea.'}]",Nutrients,['10.3390/nu12061816'] 2366,32570855,"Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy.","This study evaluated the effect of action observation training on spasticity, gross motor function, and balance in children with spastic diplegia cerebral palsy. Eighteen children with cerebral palsy participated in this study. The participants were randomized into the action observation training group ( n = 9) and a control group ( n = 9). The action observation training group repeatedly practiced the action with their motor skills, while the control group practiced conventional physical therapy. Both groups received 30 min sessions, 3 days a week, for 6 weeks. To confirm the effects of intervention, the spasticity, gross motor function measurement (GMFM), and pediatric reaching test (PRT) were evaluated. The results showed that in the plantar flexor contracture test of both sides, the Modified Tardieu Scale (MTS) of the right side of knee joints, GMFM-B, C, and D were significantly increased between pre- and post-intervention within both groups ( p < 0.05). PRT was significantly increased between pre- and post-intervention within the both groups ( p < 0.05), and there was a significant difference between the two groups ( p < 0.05). These results suggest that action observation training is both feasible and beneficial for improving spasticity, gross motor function, and balance in children with spastic diplegia cerebral palsy.",2020,"PRT was significantly increased between pre- and post-intervention within the both groups ( p < 0.05), and there was a significant difference between the two groups ( p < 0.05).","['Children with Diplegia Cerebral Palsy', 'Eighteen children with cerebral palsy', 'children with spastic diplegia cerebral palsy']","['action observation training', 'Action Observation Training', 'control group practiced conventional physical therapy']","['PRT', 'plantar flexor contracture test of both sides, the Modified Tardieu Scale (MTS) of the right side of knee joints, GMFM-B, C, and D', 'Spasticity, Gross Motor Function, and Balance', 'spasticity, gross motor function measurement (GMFM), and pediatric reaching test (PRT', 'spasticity, gross motor function, and balance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0154701', 'cui_str': 'Diplegia of upper limbs'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0270804', 'cui_str': 'Diplegic cerebral palsy'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0020687', 'cui_str': 'Hypoxanthine phosphoribosyltransferase'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",18.0,0.0103191,"PRT was significantly increased between pre- and post-intervention within the both groups ( p < 0.05), and there was a significant difference between the two groups ( p < 0.05).","[{'ForeName': 'Young-A', 'Initials': 'YA', 'LastName': 'Jeong', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, 01795 Seoul, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, 01795 Seoul, Korea.'}]","Children (Basel, Switzerland)",['10.3390/children7060064'] 2367,32570930,Long-Term Efficacy of the Workshop Vs. Online SUCCEAT (Supporting Carers of Children and Adolescents with Eating Disorders) Intervention for Parents: A Quasi-Randomised Feasibility Trial.,"Interventions for main carers of adult patients with anorexia nervosa (AN) can reduce the caregiving burden and increase caregiver skills. However, the effectiveness and feasibility for carers of adolescent patients, the optimal form of the intervention and long-term outcomes are largely unknown. We evaluated the efficacy and feasibility of the ""Supporting Carers of Children and Adolescents with Eating Disorders in Austria"" (SUCCEAT) workshop vs. online intervention. Main caregivers (parents) of adolescent patients with AN were randomly allocated to a workshop ( n = 50) or online version ( n = 50). Participants were compared to a non-randomised comparison group ( n = 49) receiving multi-family or systemic family therapy. Primary (General Health Questionnaire) and secondary outcomes were obtained at baseline, three-month and 12-month follow-up. Adherence was high for workshop and online participants (6.2 and 6.7 sessions completed out of 8). Intention-to-treat analyses revealed significant pre-post reductions in the primary outcome for the workshop (d = 0.87 (95%conficence interval (CI): 0.48; 1.26)) and online (d = 0.65 (95%CI: 0.31; 0.98)) intervention that were sustained at the 12-month follow-up. There was no significant group difference ( p = 0.473). Parental psychopathology and burden decreased and caregiver skills increased in all groups; the improvement of caregiver skills was significantly higher in SUCCEAT participants than in the comparison group. Online interventions for parents of adolescents with AN were equally effective as workshops. The improvements remained stable over time.",2020,Parental psychopathology and burden decreased and caregiver skills increased in all groups; the improvement of caregiver skills was significantly higher in SUCCEAT participants than in the comparison group.,"['Supporting Carers of Children and Adolescents with Eating Disorders in Austria"" (SUCCEAT) workshop vs. online intervention', 'carers of adolescent patients', 'Supporting Carers of Children and Adolescents with Eating Disorders', 'Parents', 'adult patients with anorexia nervosa (AN', 'parents of adolescents with AN', 'Main caregivers (parents) of adolescent patients with AN']","['multi-family or systemic family therapy', 'Online SUCCEAT', 'workshop ( n = 50) or online version']","['efficacy and feasibility', 'Parental psychopathology and burden decreased and caregiver skills', 'improvement of caregiver skills', 'Adherence']","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.108054,Parental psychopathology and burden decreased and caregiver skills increased in all groups; the improvement of caregiver skills was significantly higher in SUCCEAT participants than in the comparison group.,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Truttmann', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Philipp', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeiler', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Franta', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Wittek', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Merl', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Schöfbeck', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Koubek', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Laczkovics', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Imgart', 'Affiliation': 'Parkland Clinic, Clinic for Psychosomatic Medicine and Psychotherapy, 34537 Bad Wildungen, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Zanko', 'Affiliation': 'Parkland Clinic, Clinic for Psychosomatic Medicine and Psychotherapy, 34537 Bad Wildungen, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Auer-Welsbach', 'Affiliation': 'Department for Neurology and child and adolescents Psychiatry, 9020 Klagenfurt am Wörthersee, Austria.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London WC2R 2LS, UK.""}, {'ForeName': 'Andreas F K', 'Initials': 'AFK', 'LastName': 'Karwautz', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wagner', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9061912'] 2368,32571269,Increasing questionnaire response: evidence from a nested RCT within a longitudinal birth cohort study.,"BACKGROUND High response rates are essential when questionnaires are used within research, as representativeness can affect the validity of studies and the ability to generalise the findings to a wider population. The study aimed to measure the response rate to questionnaires from a large longitudinal epidemiological study and sought to determine if any changes made throughout data collection had a positive impact on the response to questionnaires and addressed any imbalance in response rates by participants' levels of deprivation. METHODS Data were taken from a prospective, comparative study, designed to examine the effects of the reintroduction of water fluoridation on children's oral health over a five-year period. Response rates were analysed for the first year of data collection. During this year changes were made to the questionnaire layout and cover letter to attempt to increase response rates. Additionally a nested randomised control trial compared the effect on response rates of three different reminders to complete questionnaires. RESULTS Data were available for 1824 individuals. Sending the complete questionnaire again to non-responders resulted in the highest level of response (25%). A telephone call to participants was the only method that appeared to address the imbalance in deprivation, with a mean difference in deprivation score of 2.65 (95% CI -15.50 to 10.20) between the responders and non-responders. CONCLUSIONS Initially, low response rates were recorded within this large, longitudinal study giving rise to concerns about non-response bias. Resending the entire questionnaire again was the most effective way of reminding participants to complete the questionnaire. As this is a less labour intensive method than for example, calling participants, more time can then be spent targeting groups who are underrepresented. In order to address these biases, data can be weighted in order to draw conclusions about the population.",2020,"As this is a less labour intensive method than for example, calling participants, more time can then be spent targeting groups who are underrepresented.","[""children's oral health over a five-year period"", '1824 individuals']",['reintroduction of water fluoridation'],"['response rates', 'Response rates', 'deprivation score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4551779', 'cui_str': 'Fluoridation'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0357407,"As this is a less labour intensive method than for example, calling participants, more time can then be spent targeting groups who are underrepresented.","[{'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Goodwin', 'Affiliation': 'The Dental Health Unit, Division of Dentistry, Williams House, University of Manchester, Manchester Science Park, Manchester, M15 6SE, UK. michaela.goodwin@manchester.ac.uk.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'The Dental Health Unit, Division of Dentistry, Williams House, University of Manchester, Manchester Science Park, Manchester, M15 6SE, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Whittaker', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crispigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tickle', 'Affiliation': 'The Dental Health Unit, Division of Dentistry, Williams House, University of Manchester, Manchester Science Park, Manchester, M15 6SE, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kelly', 'Affiliation': 'Primary Care Unit, Institute of Public Health, University of Cambridge, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Iain A', 'Initials': 'IA', 'LastName': 'Pretty', 'Affiliation': 'The Dental Health Unit, Division of Dentistry, Williams House, University of Manchester, Manchester Science Park, Manchester, M15 6SE, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01034-7'] 2369,32571274,The impact of sleep deprivation and alcohol on driving: a comparative study.,"BACKGROUND There is concern about the detrimental effects of shift-workers' increasing working hours particularly when driving sleep deprived. The approach to measuring the magnitude of driving impairment caused by sleep deprivation was by comparing it to alcohol. The study compared driving performance after 24-h of wakefulness to performance with a BrAC of just over 22 μg/100mls of breath which is equal to 50 mg of alcohol per 100mls of blood (Scottish drink-drive limit). The effectiveness of coffee as a countermeasure for driver fatigue and the association between subjective impairment and actual performance was also investigated. METHODS A study of 30 participants (11 male and 19 female; mean age 21) was conducted. Subjects were tested under three conditions: fully rested, sleep deprived, and alcohol intoxicated - BrAC mean [SD] 25.95 μg [2.78]. Under each condition, subjects were tested before and after coffee ingestion. This involved driving simulation (Lane Change Task and Reaction Test) and subjective Likert scales (Karolinska Sleepiness Scale and driver impairment scale). Outcome measures included lane tracking adaptive mean deviation, reaction time, and subjective sleepiness and impairment ratings. RESULTS Compared to alcohol, sleep deprived mean reaction times were slower (2.86 s vs. 2.34 s) and lateral control of the vehicle was reduced (lane tracking adaptive mean deviation: 0.5 vs. 0.3). Coffee did not produce an improvement when sleep deprived, and instead, performance deteriorated. Females were less impaired following sleep deprivation than males. Following prolonged wakefulness, the correlation between subjective impairment and actual performance was significant. CONCLUSIONS It was concluded that sleep deprivation has a greater impact on driving performance than a BrAC of 22 μg/100mls of breath, as measured by driving simulation. Coffee is not an effective countermeasure for sleep deprived driving and drivers' ability to judge this impairment is suggested to be limited.",2020,"Compared to alcohol, sleep deprived mean reaction times were slower (2.86 s vs. 2.34 s) and lateral control of the vehicle was reduced (lane tracking adaptive mean deviation: 0.5 vs. 0.3).",['30 participants (11 male and 19 female; mean age 21'],[],"['lane tracking adaptive mean deviation, reaction time, and subjective sleepiness and impairment ratings', 'mean reaction times', 'subjective impairment and actual performance', 'driving simulation (Lane Change Task and Reaction Test) and subjective Likert scales (Karolinska Sleepiness Scale and driver impairment scale']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]",30.0,0.02631,"Compared to alcohol, sleep deprived mean reaction times were slower (2.86 s vs. 2.34 s) and lateral control of the vehicle was reduced (lane tracking adaptive mean deviation: 0.5 vs. 0.3).","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lowrie', 'Affiliation': 'University of Dundee, Nethergate, Dundee, DD1 4HN, Scotland. joanna.lowrie@nhs.net.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brownlow', 'Affiliation': 'The Centre for Forensic & Legal Medicine, 2 Park Pl, Dundee, DD1 4HR, Scotland.'}]",BMC public health,['10.1186/s12889-020-09095-5'] 2370,32571284,Interference of functional dual-tasks on gait in untrained people with Parkinson's disease and healthy controls: a cross-sectional study.,"BACKGROUND In Parkinson's disease (PD) population, performing secondary tasks while walking further deteriorates gait and restrict mobility in functional contexts of daily life. This study (1) analyzed the interference of functional cognitive and motor secondary task on untrained people with PD and (2) compared their walking with healthy subjects. METHODS Forty people with PD (aged 66.72 [7.5] years, Hoehn and Yahr stage I-II-III, on-medication) composed the PD group (PDG) and 43 participants (aged 66.60 [8.75] years) formed the group of healthy counterparts (HG). Gait was evaluated through spatiotemporal, kinematic and kinetic outcomes in five conditions: single task (ST) and visual, verbal, auditory and motor dual-task (DT). RESULTS The velocity, stride length, and braking force performance of both groups was statistically higher in the ST condition than in verbal, auditory and motor DT (p < .05), and inferior in double support time and midstance force (p < .05). The same pattern was observed when compared the ST and visual DT condition, where participants showed a significantly higher stride length, double support time and braking force in the ST (p < .05). In addition, the PDG exhibited a significant shorter double support time and midstance force, and showed a higher braking force in the visual DT than in the verbal DT (p < .05). Similarly, the PDG showed a wider stride in the visual DT than in the motor DT condition (p < .05). PDG participants had a significantly lower performance than the HG in all the variables analyzed except for the maximum hip extension in the stance phase (p > .05). CONCLUSIONS In untrained participants with PD, verbal and motor secondary tasks affect gait significantly, while auditory and visual tasks interfere to a lesser extent. Untrained people with PD have a poorer gait performance than their healthy counterparts, but in different grades according to the analyzed variables. TRIAL REGISTRATION The data in this paper are part of a single-blind, randomized, controlled trial and correspond to the evaluations performed before a physical rehabilitation program, retrospectively registered with the number at clinicaltrial.govNCT04038866.",2020,"PDG participants had a significantly lower performance than the HG in all the variables analyzed except for the maximum hip extension in the stance phase (p > .05). ","['Forty people with PD (aged 66.72 [7.5] years, Hoehn and Yahr', ""untrained people with Parkinson's disease and healthy controls"", 'Untrained people with PD', 'and 43 participants (aged 66.60 [8.75] years) formed the group of healthy counterparts (HG', 'untrained people with PD and (2) compared their walking with healthy subjects']","['PD group (PDG', 'functional dual-tasks']","['velocity, stride length, and braking force performance', 'gait performance', 'ST and visual DT condition', 'double support time and midstance force', 'stride length, double support time and braking force in the ST', 'task (ST) and visual, verbal, auditory and motor dual-task (DT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517881', 'cui_str': '8.75'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",40.0,0.0759191,"PDG participants had a significantly lower performance than the HG in all the variables analyzed except for the maximum hip extension in the stance phase (p > .05). ","[{'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'San Martín Valenzuela', 'Affiliation': 'Unit of Personal Autonomy, Dependency and Mental Disorder Assessment, Faculty of Medicine, Blasco Ibáñez, 15, 46010, Valencia, Spain.'}, {'ForeName': 'Lirios', 'Initials': 'L', 'LastName': 'Dueñas Moscardó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'López-Pascual', 'Affiliation': 'Biomechanics Institute of Valencia, Polytechnic University of Valencia, Camino de Vera, s/n, 46022, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010, Valencia, Spain. pilar.serra@uv.es.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Tomás', 'Affiliation': 'Department of Behavioral Sciences Methodology, Faculty of Psychology, University of Valencia, Blasco Ibánez Avenue, 13, 46010, Valencia, Spain.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03431-x'] 2371,32571311,Improving the evaluation of COPD exacerbation treatment effects by accounting for early treatment discontinuations: a post-hoc analysis of randomized clinical trials.,"BACKGROUND Chronic obstructive pulmonary disease (COPD) clinical trials aimed at evaluating treatment effects on exacerbations often suffer from early discontinuations of randomized treatment. Treatment discontinuations imply a loss of information and should ideally be considered in the statistical analysis of trial results, particularly if the discontinuations are related to the disease or treatment itself. Here, we explore this issue by investigating (1) whether there exists an association between the risks of exacerbation and treatment discontinuation in COPD clinical trials and (2) whether disregarding this association can cause bias in exacerbation treatment effect estimates. We focus on the hypothetical estimand, i.e. the treatment effect that would have been observed had all subjects completed the trial as planned. METHODS The association between exacerbation and discontinuation risks was analysed by applying a joint frailty (random effect) model - allowing for the simultaneous analysis of multiple types of correlated events - to data from five Phase III-IV COPD clinical trials. Specifically, the impact of the association on exacerbation treatment effect estimates was assessed by comparing the treatment hazard ratios of the joint frailty model to the rate/hazard ratios of two related statistical models (the negative binomial and shared frailty models), which both assume discontinuations to be unrelated to the trial outcome. The models were also compared using simulated data. RESULTS A statistically significant (p < 0.0001), positive association between exacerbation and discontinuation risks was found in all trials. Importantly, simulations confirmed that - with such an association - models disregarding the association risk producing biased results (> 5 percentage point difference in hazard/rate ratio). For some treatment comparisons in the clinical trials, the difference in treatment effect estimates between the joint frailty and the other models was as high as 10-15 percentage points. The difference was affected by the strength of the exacerbation-discontinuation association, the population heterogeneity in exacerbation risk, and the difference in discontinuation rates between treatment arms. CONCLUSIONS We have identified an association between the risks of exacerbation and treatment discontinuation in five COPD clinical trials. We recommend using the joint frailty model to account for this association when estimating exacerbation treatment effects, particularly when targeting the hypothetical estimand.",2020,"RESULTS A statistically significant (p < 0.0001), positive association between exacerbation and discontinuation risks was found in all trials.",['Chronic obstructive pulmonary disease (COPD'],[],"['discontinuation rates', 'strength of the exacerbation-discontinuation association', 'positive association between exacerbation and discontinuation risks', 'exacerbation and discontinuation risks']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",[],"[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0730517,"RESULTS A statistically significant (p < 0.0001), positive association between exacerbation and discontinuation risks was found in all trials.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Król', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Palmér', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Rondeau', 'Affiliation': 'Biostatistics Team, INSERM CR1219, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rennard', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Ulf G', 'Initials': 'UG', 'LastName': 'Eriksson', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jauhiainen', 'Affiliation': 'BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, AstraZeneca, Pepparedsleden 1, SE-431 83, Mölndal, Sweden. alexandra.jauhiainen@astrazeneca.com.'}]",Respiratory research,['10.1186/s12931-020-01419-8'] 2372,32571397,Clinical efficacy of ceramic versus resin-based composite endocrowns in Chinese adults: study protocol for a randomized controlled trial.,"BACKGROUND Endocrown restoration is widely used to restore endodontically treated teeth. However, the clinical effects of different computer-aided design/computer-aided manufacturing (CAD/CAM) materials for endocrown restoration are not clear. The primary objective of this trial is to compare the clinical efficacy of resin-based bloc and ceramic endocrowns for restoring endodontically treated teeth. METHODS The proposed resin-based bloc and ceramic endocrown assessment trial is a parallel group-designed randomized controlled trial. We will recruit 156 adults between 18 and 75 years old with a minimum of one such molar. The inclusion criteria were good oral hygiene habits, root apex of molar without evident damage, receipt of standard endodontic treatment, need for endocrown restoration, and only one endocrown restoration performed per patient. Patients participating in another study or those with systemic diseases, disabilities, or known allergies to used materials will be excluded. All patients will be randomized and restored with resin-based bloc and ceramic endocrown according to a random number table. Clinical evaluations will be performed at baseline and after treatment at 6, 12, and 24 months, in accordance with the modified Federation Dentaire Internationale (FDI) criteria, by two independent evaluators. The primary outcome is marginal adaptation; secondary outcomes include wear, tooth integrity, fracture of material and retention, marginal staining, and patient view. All data will be analyzed by an independent statistician. Signed rank-sum tests will be used for intragroup comparisons. Wilcoxon rank-sum tests will be used for intergroup comparisons. Hierarchical logistic regression will be used to adjust the baseline and other important indicators. DISCUSSION This study will investigate endocrowns of two CAD/CAM materials for endodontically treated molars. The results may help clinicians choose the better CAD/CAM material option and explain to patients the advantages and disadvantages of these two materials with evidence-based support. For patients, the results may lead to improvement in long-term restoration. TRIAL REGISTRATION ClinicalTrials.gov NCT04033380. Registered on 24 July 2019.",2020,"The primary objective of this trial is to compare the clinical efficacy of resin-based bloc and ceramic endocrowns for restoring endodontically treated teeth. ","['Chinese adults', '156 adults between 18 and 75\u2009years old with a minimum of one such molar', 'Patients participating in another study or those with systemic diseases, disabilities, or known allergies to used materials will be excluded']","['resin-based bloc and ceramic endocrowns', 'ceramic versus resin-based composite endocrowns', 'resin-based bloc and ceramic endocrown']","['marginal adaptation; secondary outcomes include wear, tooth integrity, fracture of material and retention, marginal staining, and patient view']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449911', 'cui_str': 'View'}]",156.0,0.145403,"The primary objective of this trial is to compare the clinical efficacy of resin-based bloc and ceramic endocrowns for restoring endodontically treated teeth. ","[{'ForeName': 'Jilei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Zhiting', 'Initials': 'Z', 'LastName': 'Ling', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Ziting', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Gai', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'The Statistics Room of Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Buling', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Conservative and Endodontic Dentistry, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Road, Guangzhou, 510515, China. 645613053@qq.com.'}]",Trials,['10.1186/s13063-020-04506-9'] 2373,32571399,The short-term effects of sedentary behaviour on cerebral hemodynamics and cognitive performance in older adults: a cross-over design on the potential impact of mental and/or physical activity.,"BACKGROUND Sedentary behaviour might be a potential risk factor for cognitive decline. However, the short-term effects of sedentary behaviour on (cerebro) vascular and cognitive performance in older people are unknown. METHODS We used a cross-over design with 22 older adults (78 years, 9 females) to assess the short-term hemodynamic and cognitive effects of three hours uninterrupted sitting and explored if these effects can be counteracted with regular (every 30 min) two-minute walking breaks. In addition, we investigated if low versus high mental activity during the three hours of sitting modified these effects. Before and after each condition, alertness, executive functioning, and working memory were assessed with the Test of Attentional Performance battery. Additionally, cerebral blood flow velocity (Transcranial Doppler) and blood pressure (Finapres) were measured in rest, and during sit-to-stand and CO 2 challenges to assess baroreflex sensitivity, cerebral autoregulation, and cerebral vasomotor reactivity. RESULTS No short-term differences were observed in cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions. Blood pressure and cerebrovascular resistance increased over time (8.6 mmHg (5.0;12.1), p < 0.001), and 0.23 in resistance (0.01;0.45), p = 0.04). However, these effects were not mitigated by mental activity or by short walking breaks to interrupt sitting. CONCLUSIONS In older individuals, three hours of sitting did not influence cognitive performance or cerebral perfusion. However, the sitting period increased blood pressure and cerebrovascular resistance, which are known to negatively impact brain health in the long-term. Importantly, we found that these effects in older individuals cannot be mitigated by higher mental activity and/or regular walking breaks. TRIAL REGISTRATION Clinical trial registration URL: https://www.toetsingonline.nl/. Unique identifier: NL64309.091.17. Date of registration: 06-02-2018.",2020,"No short-term differences were observed in cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions.","['older people', 'older adults', '22 older adults (78\u2009years, 9 females', 'older individuals']",['sedentary behaviour'],"['blood pressure and cerebrovascular resistance', 'cerebral hemodynamics and cognitive performance', 'baroreflex sensitivity, cerebral autoregulation, and cerebral vasomotor reactivity', 'alertness, executive functioning, and working memory', 'cognitive performance or cerebral perfusion', 'Blood pressure and cerebrovascular resistance', 'mental activity and/or regular walking breaks', 'Attentional Performance battery', 'cerebral blood flow velocity (Transcranial Doppler) and blood pressure (Finapres', 'cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",22.0,0.07167,"No short-term differences were observed in cognitive performance, cerebral blood flow velocity, baroreflex sensitivity, cerebral autoregulation, or cerebral vasomotor reactivity across time, or between conditions.","[{'ForeName': 'Carlijn M', 'Initials': 'CM', 'LastName': 'Maasakkers', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'René J F', 'Initials': 'RJF', 'LastName': 'Melis', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology/Radboudumc Alzheimer Center, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gardiner', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jurgen A H R', 'Initials': 'JAHR', 'LastName': 'Claassen', 'Affiliation': 'Department of Geriatrics/Radboud Alzheimer Center, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands. Jurgen.Claassen@radboudumc.nl.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00644-z'] 2374,32571403,"Correction to: Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['adult patients with phenylketonuria (the PICO study'],"['phenylalanine', 'placebo']","['cognitive, cerebral, and neurometabolic parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.158712,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Trepp', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Raphaela', 'Initials': 'R', 'LastName': 'Muri', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Abgottspon', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Bosanska', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hochuli', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Slotboom', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rummel', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kreis', 'Affiliation': 'Magnetic Resonance Methodology Unit, Department of Biomedical Research & Institute of Interventional, Diagnostic and Pediatric Radiology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Regula', 'Initials': 'R', 'LastName': 'Everts', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland. regula.everts@insel.ch.'}]",Trials,['10.1186/s13063-020-04489-7'] 2375,32571411,Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial.,"BACKGROUND Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stage 1 hypertension to evaluate the effect of TEAS. METHODS/DESIGN The study will be a two-arm parallel, randomized controlled trial. Sixty patients with stage 1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. The participants in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at four acupoints in the upper and lower extremities at home, 4 times weekly for 12 weeks for a total of 48 sessions. Participants in the control group will not receive any form of acupoint stimulation. All participants in both groups will receive lifestyle education on how to control high blood pressure, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean systolic blood pressure from baseline to 12 weeks. Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level. DISCUSSION This pilot, randomized, controlled trial will explore the feasibility of TEAS. It will also provide potential clinical evidence for the efficacy and safety of TEAS in the treatment of patients with stage 1 hypertension. The results of this study will be published in peer-reviewed journals. Furthermore, this pilot trial as the precursor of a large scale randomized controlled trial will inform the sample size of the subsequent trial. TRIAL REGISTRATION Chinese clinical trial registry, ChiCTR1900025042, Registered on 8 August 2019 (http://www.chictr.org.cn/showproj.aspx?proj=41496).",2020,"Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level. ","['stage 1 hypertension', 'Sixty patients with stage 1 hypertension', 'hypertension', 'patients with stage 1 hypertension']","['lifestyle education on how to control high blood pressure, including diet, weight control, and exercise', 'Transcutaneous electrical acupoint stimulation (TEAS', 'TEAS', 'Transcutaneous electrical acupoint stimulation', 'acupoint stimulation', 'TEAS group will receive non-invasive acupoint electrical stimulation']","['change of the mean systolic blood pressure', 'change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level']","[{'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.157429,"Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level. ","[{'ForeName': 'Zhong-Xue', 'Initials': 'ZX', 'LastName': 'Tian', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'You-Sheng', 'Initials': 'YS', 'LastName': 'Qi', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Jun-Hong', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China. wangliqiongwork@163.com.'}]",Trials,['10.1186/s13063-020-04493-x'] 2376,32571454,[Effect of early continuous blood purification on the prognosis of children with septic shock: a prospective randomized controlled clinical trial].,"OBJECTIVE To study the effect of early continuous blood purification (CBP) on the prognosis of children with septic shock. METHODS A prospective analysis was performed for the children with septic shock who did not reach the 6-hour initial recovery target and/or had a fluid overload of >10%. According to the treatment time of CBP, they were divided into an early group with 30 children and a conventional group with 28 children. The two groups were compared in terms of the start time of CBP and 28-day mortality rate, as well as the related indexes in the children who were cured. RESULTS The early group had a significantly earlier start time of CBP than the conventional group (P<0.05). There were 25 children cured in the early group and 22 cured in the conventional group, and there was no significant difference in 28-day mortality rate between the two groups (P>0.05). The children who were cured in the early group had significantly shorter correction time of lactic acid, urine volume, and fluid overload than those in the conventional group (P<0.05). The children who were cured in both groups had significant reductions in the percentages of T-lymphocyte subsets at the beginning (P<0.05); on reexamination on day 7, the percentages of T-lymphocyte subsets were increased and were higher in the early group than in the conventional group (P<0.05). The children who were cured in the early group had significantly shorter duration of CBP treatment, duration of mechanical ventilation, and length of stay in the PICU than those in the conventional group (P<0.05). CONCLUSIONS For children with septic shock who do not reach the 6-hour initial recovery target and/or have a fluid overload of >10%, early CBP treatment can quickly control the disease, shorten the course of disease, and accelerate immune reconstruction.",2020,The early group had a significantly earlier start time of CBP than the conventional group (P<0.05).,"['children with septic shock who did not reach the 6-hour initial recovery target and/or had a fluid overload of >10', 'children with septic shock']","['early continuous blood purification (CBP', 'early continuous blood purification']","['start time of CBP and 28-day mortality rate', 'percentages of T-lymphocyte subsets', 'earlier start time of CBP', '28-day mortality rate', 'shorter duration of CBP treatment, duration of mechanical ventilation, and length of stay in the PICU', 'shorter correction time of lactic acid, urine volume, and fluid overload']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0560523', 'cui_str': 'Does not reach'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0243114', 'cui_str': 'purification'}]","[{'cui': 'C1301880', 'cui_str': 'Start time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0243114', 'cui_str': 'purification'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}]",25.0,0.0511144,The early group had a significantly earlier start time of CBP than the conventional group (P<0.05).,"[{'ForeName': 'You-Jun', 'Initials': 'YJ', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care Medicine, Guangxi Maternity and Child Health Hospital, Nanning 530000, China. xieyoujun55@163.com.'}, {'ForeName': 'Wu-Gui', 'Initials': 'WG', 'LastName': 'Mo', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Yu-Peng', 'Initials': 'YP', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Gong-Zhi', 'Initials': 'GZ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Zhi-Rong', 'Initials': 'ZR', 'LastName': 'Mo', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[] 2377,32571537,Enhanced recovery after surgery for the treatment of congenital duodenal obstruction.,"BACKGROUND Enhanced recovery after surgery (ERAS) has been widely used in adult surgery. However, ERAS has not been reported in neonatal surgery. The present prospective study explored the application value of ERAS in treating congenital duodenal obstruction (CDO). METHODS A total of 68 cases of CDO were collected from October 1, 2017 to July 31, 2019. We divided patients with a prenatal diagnosis of congenital duodenal obstruction into the ERAS group and those who were diagnosed the disease after birth into the control group. The ERAS group adopted ERAS-related measures, and the control group followed the usual measures. The study compared the differences in the gestational age, birth weight, length of hospital stay (LOS), complications, feeding intolerance, and weight one month after surgery between the two groups. RESULTS A total of 49 patients were included in the analysis, including 23 who were allocated to the ERAS group and 26 to the control group. The LOS was 9.696±1.222 days in the ERAS group and 12.654±1.686 days in the control group, resulting in a significantly shorter LOS in the ERAS group than in the control group (p<0.001). One month after surgery, the neonates in the ERAS group weighted significantly more than those in the control group. No differences were observed in birth weight, gestational age, and the incidence of complications or feeding intolerance between the two groups. CONCLUSION In this single-center study, the implementation of neonate-specific ERAS for CDO surgery was feasible and safe and led to a shorter LOS without increasing the incidence of complications or feeding intolerance. TYPE OF STUDY Treatment Study LEVEL OF EVIDENCE: Level III.",2020,"No differences were observed in birth weight, gestational age, and the incidence of complications or feeding intolerance between the two groups. ","['divided patients with a prenatal diagnosis of congenital duodenal obstruction into the ERAS group and those who were diagnosed the disease after birth into the control group', 'congenital duodenal obstruction', 'congenital duodenal obstruction (CDO', 'A total of 68 cases of CDO were collected from October 1, 2017 to July 31, 2019', 'A total of 49 patients were included in the analysis, including 23 who were allocated to the ERAS group and 26 to the control group']","['surgery (ERAS', 'ERAS']","['birth weight, gestational age, and the incidence of complications or feeding intolerance', 'shorter LOS', 'gestational age, birth weight, length of hospital stay (LOS), complications, feeding intolerance, and weight one month', 'LOS']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033053', 'cui_str': 'Intrauterine Diagnosis'}, {'cui': 'C0266181', 'cui_str': 'Congenital duodenal obstruction'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4082115', 'cui_str': 'One month'}]",49.0,0.0265272,"No differences were observed in birth weight, gestational age, and the incidence of complications or feeding intolerance between the two groups. ","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Li-Ke', 'Initials': 'LK', 'LastName': 'Yuan', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Jia-Ying', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Yang', 'Affiliation': 'Reproductive Health and Infertility Center, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Xiao-Chun', 'Initials': 'XC', 'LastName': 'Zhu', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Su-Yan', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Hui-Yang', 'Initials': 'HY', 'LastName': 'Ding', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Mu-Dan', 'Initials': 'MD', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Shang-Jie', 'Initials': 'SJ', 'LastName': 'Xiao', 'Affiliation': ""Guangdong Women and Children's Hospital, Guangzhou Medical University. Electronic address: drsiow@163.com.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.04.015'] 2378,32571538,Safety and efficacy of trigonal BTX-A injections for children with neurological detrusor overactivity secondary to spinal cord injury.,"OBJECTIVE To evaluate the efficacy and safety of trigonal botulinum toxin A (BTX-A) injections for children with neurological detrusor overactivity (NDO) secondary to spinal cord injury (SCI). METHODS From February 2012 to December 2018, children with NDO secondary to SCI were enrolled. All patients received 200U BTX-A intradetrusor injections including the trigone. Videourodynamic study was performed at baseline and 12 weeks after injection. The primary outcome measures were the presence of vesicoureteral reflux and standardized urodynamic measures. Secondary outcomes included incontinence quality of life questionnaire (I-QoL), voiding volume, urinary incontinence episodes, and complete dryness. RESULTS A total of 33 pediatric inpatients (28 male and 5 female) completed the study. No one developed VUR at week 0 or week 12. At the first instance of NDO, maximum detrusor pressure (PdetmaxFNDO) and NDO duration were reduced by 29.8% and 31.8%, respectively, whereas NDO volume (VFNDO) increased by 50.5%,12 weeks after injection. Mean urinary incontinence episodes were reduced by 31.7%, whereas voiding volume and I-QOL were increased by 52.9% and 23.3%. 3 patients reported mild transient hematuria during the first week after injection. CONCLUSIONS Our results suggest that the use of bladder-trigone-including intradetrusor BTX-A injection does not induce VUR, and is safe and effective in children with NDO secondary to SCI. TYPE OF STUDY A prospective self-controlled trial LEVEL OF EVIDENCE: Level II.",2020,"Mean urinary incontinence episodes were reduced by 31.7%, whereas voiding volume and I-QOL were increased by 52.9% and 23.3%.","['children with NDO secondary to SCI', 'children with neurological detrusor overactivity secondary to spinal cord injury', '33 pediatric inpatients (28 male and 5 female) completed the study', 'children with neurological detrusor overactivity (NDO) secondary to spinal cord injury (SCI', 'From February 2012 to December 2018, children with NDO secondary to SCI were enrolled']","['200U BTX-A intradetrusor injections including the trigone', 'trigonal botulinum toxin A (BTX-A) injections', 'trigonal BTX-A injections']","['presence of vesicoureteral reflux and standardized urodynamic measures', 'incontinence quality of life questionnaire (I-QoL), voiding volume, urinary incontinence episodes, and complete dryness', 'NDO volume (VFNDO', 'Mean urinary incontinence episodes', 'Safety and efficacy', 'maximum detrusor pressure (PdetmaxFNDO) and NDO duration', 'VUR', 'voiding volume and I-QOL', 'mild transient hematuria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0447586', 'cui_str': 'Trigonal structure'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4551858', 'cui_str': 'Vesicoureteral Reflux 1'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}]",33.0,0.0847123,"Mean urinary incontinence episodes were reduced by 31.7%, whereas voiding volume and I-QOL were increased by 52.9% and 23.3%.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hui', 'Affiliation': 'Department of Urology, Guangdong Provincial Work Injury Rehabilitation Hospital, Guangzhou, China, 510440. Electronic address: doc.chenhui@163.com.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.05.019'] 2379,32571567,Direct Oral Anticoagulants in the Setting of Catheter Ablation of Atrial Fibrillation: State of art.,"Atrial fibrillation (AF) represents the arrhythmia of greatest clinical impact and catheter ablation of AF (CAAF) has become the most effective strategy for rhythm control in selected patients. Therefore, appropriate anticoagulation strategies are of paramount importance for patients undergoing CAAF, especially those at high risk, such those with high CHA2DS2VASc scores. Optimal management of anticoagulation before, during, and after CAAF is crucial. Several studies have evaluated the use of different anticoagulation strategies in the periprocedural period. Randomized controlled trial seem to suggest that in patients undergoing CAAF, uninterrupted (or minimally interrupted) direct oral anticoagulants (DOACs) provides an alternative to continuous vitamin K antagonists strategy, with low thromboembolic and bleeding risk.",2020,Atrial fibrillation (AF) represents the arrhythmia of greatest clinical impact and catheter ablation of AF (CAAF) has become the most effective strategy for rhythm control in selected patients.,['patients undergoing'],"['CAAF, uninterrupted (or minimally interrupted) direct oral anticoagulants (DOACs', 'catheter ablation of AF (CAAF']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",[],,0.0202978,Atrial fibrillation (AF) represents the arrhythmia of greatest clinical impact and catheter ablation of AF (CAAF) has become the most effective strategy for rhythm control in selected patients.,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Coppola', 'Affiliation': ''}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Corrado', 'Affiliation': ''}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Luparelli', 'Affiliation': ''}, {'ForeName': 'Girolamo', 'Initials': 'G', 'LastName': 'Manno', 'Affiliation': ''}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Mignano', 'Affiliation': ''}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Ciaramitaro', 'Affiliation': ''}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Boveda', 'Affiliation': ''}]",Current problems in cardiology,['10.1016/j.cpcardiol.2020.100622'] 2380,32571570,A consensus checklist to help clinicians interpret clinical trial results analysed by Bayesian methods.,"INTRODUCTION In the context of an increasing number of publications of trial data analysed by Bayesian methods, clinicians need support to better understand Bayesian statistical methods. The existing checklists are intended for people who already know these methods. We aimed to establish and validate a checklist that contains a group of items considered crucial in interpreting the results of a phase III RCT analysed with Bayesian methods. METHODS A team of biostatisticians created a checklist of previously reported items and additional items identified from a literature review. Using three different articles in three rounds, the items were then validated by residents in anaesthesiology with no skills in statistics. RESULTS Based on an initial item list, three rounds led to a consensus checklist. Eleven items were considered important information to be specified for understanding the validity of the results. Of these, three were considered essential: specification of the prior, source of the prior (when prior is informative), and the effect size point estimate with its credible interval. CONCLUSION The checklist can help clinicians interpret the results of a phase III randomised clinical trial analysed by Bayesian methods, even clinicians with no particular knowledge of statistics, to ensure that the major elements of the statistical section are present and valid. Care should be taken in interpreting the results of a trial analysed by Bayesian methods that are not reported with these three essential items because the validity of the results cannot be established.",2020,"Using three different articles in three rounds, the items were then validated by residents in anaesthesiology with no skills in statistics. ",[],[],[],[],[],[],11.0,0.0629078,"Using three different articles in three rounds, the items were then validated by residents in anaesthesiology with no skills in statistics. ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ferreira', 'Affiliation': 'Anesthesiology and Intensive Care Department, CHU Besançon, Besançon, France; Université de Strasbourg, iCUBE, UMR7357, Illkirch Cedex, France. Electronic address: dferreira@chu-besancon.fr.'}, {'ForeName': 'Mael', 'Initials': 'M', 'LastName': 'Barthoulot', 'Affiliation': ""Institut Pasteur de Lille, Unité d'Epidémiologie et de Santé Publique, Inserm-U1167, Lille, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Pottecher', 'Affiliation': 'Anesthesiology and Intensive Care Department, CHU de Strasbourg, IHU-Strasbourg, Strasbourg, France.'}, {'ForeName': 'Klaus D', 'Initials': 'KD', 'LastName': 'Torp', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Diemunsch', 'Affiliation': 'Anesthesiology and Intensive Care Department, CHU de Strasbourg, IHU-Strasbourg, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Université de Strasbourg, iCUBE, UMR7357, Illkirch Cedex, France; Public Health Department, CHU de Strasbourg, GMRC, Strasbourg, France.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.04.093'] 2381,32571602,"Exercise handout and one-on-one hand therapy for management of stiffness after plaster cast immobilization of simple phalangeal and metacarpal fractures in children: A randomized, noninferiority trial.","STUDY DESIGN This is a noninferior, single-blind, randomized controlled trial. INTRODUCTION Joint stiffness is common after plaster cast immobilization for simple phalanx and metacarpal fractures in children. The limited literature suggests this joint stiffness in children resolves without one-on-one therapy; however, without robust studies confirming that there is no detrimental effect from withdrawing treatment, many children are still referred. PURPOSE OF THE STUDY The purpose of this study was to determine if an educational handout for self-management of stiffness is noninferior to one-on-one hand therapy for achieving full range of motion (ROM). METHODS Participants were randomly assigned to group one who received the handout or group two who received hand therapy in addition to the handout. The ROM was measured by composite flexion and total active motion (TAM). The noninferiority margin was 10% difference between the two groups in the proportion of participants who achieved full ROM at two weeks after cast removal. RESULTS Sixty participants in each group completed the study. Group difference for composite flexion was 1.7% (95% CI: -3.9% to 7.2%), demonstrating noninferiority. Group difference for TAM was inconclusive at 8.3% (95% CI: -2.1% to 18.7%). Sensitivity analysis adjusting for participants with full composite flexion at the baseline resulted in the group difference for composite flexion of 3.1% (95% CI: -3.6% to 9.8%), maintaining noninferiority, but group difference for TAM at 10.4% (95% CI: 0.0% to 20.9%), was inconclusive with the handout group significantly worse. CONCLUSION An educational handout is noninferior to hand therapy for achieving full ROM in composite flexion but not TAM. This needs to be taken into consideration for changing clinical practise.",2020,Group difference for TAM was inconclusive at 8.3% (95% CI: -2.1% to 18.7%).,"['simple phalangeal and metacarpal fractures in children', 'Participants', 'simple phalanx and metacarpal fractures in children', 'Sixty participants in each group completed the study']","['TAM', 'Exercise handout and one-on-one hand therapy']","['composite flexion', 'full ROM', 'composite flexion and total active motion (TAM']","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0272677', 'cui_str': 'Fracture of metacarpal bone'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222682', 'cui_str': 'Phalanx structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}]",,0.163378,Group difference for TAM was inconclusive at 8.3% (95% CI: -2.1% to 18.7%).,"[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia. Electronic address: Cheng.Tan@health.wa.gov.au.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Depiazzi', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Department of Clinical Research and Education, Child Adolescent Health Service, Perth, Western Australia, Australia.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Blennerhassett', 'Affiliation': 'Department of Plastics and Reconstructive Surgery, Child and Adolescent Health Service, Perth, Western Australia, Australia.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'Department of Plastics and Reconstructive Surgery, Child and Adolescent Health Service, Perth, Western Australia, Australia.'}, {'ForeName': 'Noula', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia.""}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.017'] 2382,32574236,Available Evidence and Ongoing Clinical Trials of Remdesivir: Could It Be a Promising Therapeutic Option for COVID-19?,"The novel coronavirus strain, severe acute respiratory syndrome coronavirus-2, the causative agent of COVID-19 emerged in Wuhan, China, in December 2019 and is skyrocketing throughout the globe and become a global public health emergency. Despite promising preventive measures being taken, there is no vaccine or drug therapy officially approved to prevent or treat the infection. Everybody is waiting the findings of ongoing clinical trials in various chemical and biological products. This review is specifically aimed to summarize the available evidence and ongoing clinical trials of remdesivir as a potential therapeutic option for COVID-19. Remdesivir is an investigational drug having broad spectrum antiviral activity with its target RNA dependent RNA polymerase. It has not yet been officially approved for Ebola and Coronaviruses. Several studies showed that remdesivir had promising in vitro and in vivo antiviral activities against SARS-CoV-1 and MERS-CoV strains. On the top of this, it exhibited a promising in vitro activity against SARS-CoV-2 strains though there are no published studies that substantiate its activity in vivo until the time of this review. There are few phase 3 randomized double-blind placebo controlled trials on the way to investigate the safety and efficacy of remdesivir. Of which, one completed double blind, placebo controlled trial showed that remdesivir showed faster time to clinical improvement in severe COVID-19 patients compared to placebo though not found statistically significant. In addition, two phase 3 randomized open label clinical trials coordinated by Gilead Sciences are being conducted. In addition, WHO Solidarity trial and INSERM DisCoVeRy trials (randomized open labels) were launched recently.",2020,"The novel coronavirus strain, severe acute respiratory syndrome coronavirus-2, the causative agent of COVID-19 emerged in Wuhan, China, in December 2019 and is skyrocketing throughout the globe and become a global public health emergency.",[],"['Remdesivir', 'placebo']","['faster time to clinical improvement', 'safety and efficacy of remdesivir']",[],"[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]",,0.530324,"The novel coronavirus strain, severe acute respiratory syndrome coronavirus-2, the causative agent of COVID-19 emerged in Wuhan, China, in December 2019 and is skyrocketing throughout the globe and become a global public health emergency.","[{'ForeName': 'Mekonnen', 'Initials': 'M', 'LastName': 'Sisay', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.00791'] 2383,32574340,Guideline-Based Chinese Herbal Medicine Treatment Plus Standard Care for Severe Coronavirus Disease 2019 (G-CHAMPS): Evidence From China.,"Background: In January, national guidelines were developed and recommended for use throughout China to fight coronavirus disease 2019 (COVID-19). Chinese herbal medicine (CHM) was also included as part of the treatment plans at various stages of COVID-19. Methods: We conducted a pilot randomized, controlled trial in patients with severe COVID-19 in Wuhan, China. Eligible adult patients were randomly assigned in a 2:1 ratio to receive either CHM plus standard care or standard care alone for 7 days. The primary outcome was the change in the disease severity category of COVID-19 after treatment. Results: Between Jan 31, 2020, and Feb 19, 2020, 42 out of 100 screened patients were included in the trial: 28 in the CHM plus standard care group and 14 in the standard care alone group. Among 42 participants who were randomized (mean [SD] age 60.43 years [12.69 years]), 21 (21/42, 50%) were aged ≥65 years, 35 (35/42, 83%) were women, and 42 (42/42, 100%) had data available for the primary outcome. For the primary outcome, one patient from each group died during treatment; the odds of a shift toward death was lower in the CHM plus group than in the standard care alone group (common OR 0.59, 95% CI 0.148-2.352, P = 0.454). Three (two from the CHM plus group and one from the standard care alone group) patients progressed from severe to critical illness. After treatment, mild, moderate, and severe COVID-19 disease accounted for 17.86% (5/28) vs. 14.29% (2/28), 71.43% (20/28) vs. 64.29% (9/28), and 0% (0) vs. 7.14% (1/28) of the patients treated with CHM plus standard care vs. standard care alone. Conclusions: For the first time, the G-CHAMPS trial provided valuable information for the national guideline-based CHM treatment of hospitalized patients with severe COVID-19. The effects of CHM in COVID-19 may be clinically important and warrant further consideration and studies. Clinical Trial Registration: http://www.chictr.org.cn/index.aspx. Uniqueidentifier: ChiCTR2000029418.",2020,"For the primary outcome, one patient from each group died during treatment; the odds of a shift toward death was lower in the CHM plus group than in the standard care alone group (common OR 0.59, 95% CI 0.148-2.352, P = 0.454).","['Results: Between Jan 31, 2020, and Feb 19, 2020, 42', 'Severe Coronavirus Disease 2019', '42 participants who were randomized (mean [SD] age 60.43 years [12.69 years]), 21 (21/42, 50%) were aged ≥65 years, 35 (35/42, 83%) were women, and 42', 'patients with severe COVID-19 in Wuhan, China', 'hospitalized patients with severe COVID-19', '100 screened patients were included in the trial: 28 in the CHM plus standard care group and 14 in the standard care alone group', 'Eligible adult patients']","['Guideline-Based Chinese Herbal Medicine Treatment Plus Standard Care', 'CHM', 'G-CHAMPS', 'Chinese herbal medicine (CHM', 'CHM plus standard care or standard care alone']","['change in the disease severity category of COVID-19', 'odds of a shift toward death', 'mild, moderate, and severe COVID-19 disease']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008525', 'cui_str': 'Choroideremia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008525', 'cui_str': 'Choroideremia'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",100.0,0.180055,"For the primary outcome, one patient from each group died during treatment; the odds of a shift toward death was lower in the CHM plus group than in the standard care alone group (common OR 0.59, 95% CI 0.148-2.352, P = 0.454).","[{'ForeName': 'Yong-An', 'Initials': 'YA', 'LastName': 'Ye', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in medicine,['10.3389/fmed.2020.00256'] 2384,32574384,Long-term follow-up of human papillomavirus (HPV) type replacement among young pregnant Finnish females before and after a community-randomised HPV vaccination trial with moderate coverage.,"Large scale human papillomavirus (HPV) vaccination against the most oncogenic high-risk human papillomavirus (HPV) types 16/18 is rapidly reducing their incidence. However, attempts at assessing if this leads to an increase of non-vaccine targeted HPV types have been hampered by several limitations, such as the inability to differentiate secular trends. We performed a population-based serological survey of unvaccinated young women over 12 years. The women were under 23-years-old, residents from 33 communities which participated in a community-randomised trial (CRT) with approximately 50% vaccination coverage. Serum samples were retrieved pre- and post- the CRT implementation. Seropositivity to 17 HPV types was assessed. HPV seroprevalence ratios (PR) comparing the post- to pre-vaccination era were estimated by trial arm. This was also assessed among the sexual risk-taking core group, where type replacement may occur more rapidly. 8022 serum samples from the population-based Finnish Maternity Cohort were retrieved in total. HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A  = 0.8, 95% CI 0.7-0.9). HPV6/11 and HPV73 were also decreased after gender-neutral vaccination (PR 6/11A  = 0.8, 95% CI 0.7-0.9, PR 73A  = 0.7, 95% CI 0.6-0.9 respectively) and girls-only vaccination (PR 6/11B  = 0.8, 95% CI 0.7-0.9, PR 73B  = 0.9, 95% CI 0.8-1.0). HPV68 alone was increased but only after girls-only vaccination (PR 68B  = 1.3, 95% CI 1.0-1.7, PR core68B  = 2.8, 95% CI 1.2-6.3). A large-scale, long-term follow-up found no type replacement in the communities with the strongest reduction of vaccine HPV types. Limited evidence for an increase in HPV68 was restricted to girls-only vaccinated communities and may have been due to secular trends. This article is protected by copyright. All rights reserved.",2020,"HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A  = 0.8, 95% CI 0.7-0.9).","['young pregnant Finnish females', '8022 serum samples from the population-based Finnish Maternity Cohort were retrieved in total', 'women were under 23-years-old, residents from 33 communities which participated in a community-randomised trial (CRT) with approximately 50% vaccination coverage', 'unvaccinated young women over 12 years']",['human papillomavirus (HPV) type replacement'],"['HPV6/11 and HPV73', 'HPV68 alone', 'HPV seroprevalence ratios (PR', 'HPV68']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0600367', 'cui_str': 'Seroprevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0730048,"HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A  = 0.8, 95% CI 0.7-0.9).","[{'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Gray', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Kann', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ville N', 'Initials': 'VN', 'LastName': 'Pimenoff', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Adhikari', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Research and Development, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heljä-Marja', 'Initials': 'HM', 'LastName': 'Surcel', 'Affiliation': 'Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Simopekka', 'Initials': 'S', 'LastName': 'Vänskä', 'Affiliation': 'Dept. of Infectious Disease Control and Vaccination, Inst. for Health & Welfare, Helsinki, Finland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Faust', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",International journal of cancer,['10.1002/ijc.33169'] 2385,32574478,Single-Sided Deafness-Outcomes of Three Interventions for Profound Unilateral Sensorineural Hearing Loss: A Randomized Clinical Trial.,"OBJECTIVE A comparison of three interventions for profound unilateral sensorineural hearing loss. STUDY DESIGN Prospective, crossover randomized clinical trial. PARTICIPANTS Fifteen participants with profound unilateral sensorineural hearing loss. INTERVENTIONS Three potential technical interventions were compared: Bone Conduction Device on softband, Contralateral Routing of Signal (CROS), and Remote Microphone . Each intervention was randomly trialed for a period of 3 weeks, separated by a 1 week washout period. OUTCOME MEASURES Speech in noise recognition test performed under four conditions (lateral noise poorer ear, lateral noise better ear, speech poorer ear, speech better ear). Standardized questionnaires (Abbreviated Profile of Hearing Aid Benefit, Bern Benefit in Single Sided Deafness Questionnaire, and Speech, Spatial, and Other Qualities 12) were used to evaluate amplification benefit at baseline and following each intervention. RESULTS The use of remote microphone provided the best results in the speech recognition in noise test. A benefit in some signal-to-noise ratios was presented of the CROS over bone conduction device on softband in the Speech Poor Ear condition. On questionnaires of benefit, participants did not rate a particular intervention as significantly better than any other. Following the study, CROS was the intervention preferred by the 8 of 15 participants (53%). The majority of participants (80%) chose to continue with an intervention rather than no treatment. CONCLUSION The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline. People with SSD are a heterogeneous population when considering perceived difficulties. Future research should focus on segmenting the population of SSD depending on factors such as etiology, high frequency loss in the better ear, and age of acquired loss for the poorer ear. This stratification may possibly increase the benefit for the patient in terms of more individual-based clinical routines.",2020,The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline.,"['Fifteen participants with profound unilateral sensorineural hearing loss', 'Profound Unilateral Sensorineural Hearing Loss']",[],"['Bone Conduction Device on softband, Contralateral Routing of Signal (CROS), and Remote Microphone ', 'Speech in noise recognition test performed under four conditions (lateral noise poorer ear, lateral noise better ear, speech poorer ear, speech better ear', 'performance in speech recognition']","[{'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}]",[],"[{'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",15.0,0.0614705,The use of all interventions resulted in increased performance in speech recognition in noise and rated higher on subjective benefits in comparison with baseline.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Fogels', 'Affiliation': 'Division of Audiology, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Radi', 'Initials': 'R', 'LastName': 'Jönsson', 'Affiliation': 'Department of Otorhinolaryngology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Division of Audiology, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Better Health, Healthcare and Treatment Global Impact Cluster, Research and Innovation, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Flynn', 'Affiliation': 'School of Humanities and Social Science, Faculty of Education and Arts, University of New Castle, Australia.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002633'] 2386,32574761,HAWK and HARRIER: 96-Week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration.,"PURPOSE To report the 96-week outcomes from HAWK and HARRIER DESIGN: Phase III, prospective, randomized, double-masked, multicenter studies comparing the efficacy and safety of brolucizumab 3mg (HAWK only) and 6mg with aflibercept 2mg in eyes with neovascular AMD (nAMD) PARTICIPANTS: Treatment naive eyes with nAMD were randomized 1:1:1 to brolucizumab 3mg (n=358), brolucizumab 6mg (n=360) or aflibercept 2mg (n=360) [HAWK], or 1:1 to brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) [HARRIER]. METHODS After three monthly loading doses, brolucizumab patients received every 12 week (q12w) dosing with the possibility of adjusting to every 8 week (q8w) dosing if disease activity was present at predefined disease activity assessment (DAA) visits. Aflibercept was dosed in a fixed q8w regimen. Visual and anatomical parameters were assessed throughout. The primary endpoint was at Week 48 (W48), with treatment and follow-up until W96. MAIN OUTCOME MEASURES Mean best corrected visual acuity (BCVA) change from baseline, proportion of patients on q12w, retinal thickness, retinal fluid changes, and safety; all to W96 RESULTS: Mean change (LS mean ±SE) in BCVA (ETDRS letters) from baseline to W96 in HAWK was 5.6 (0.79) for brolucizumab 3mg, 5.9 (0.78) for brolucizumab 6mg and 5.3 (0.78) for aflibercept and in HARRIER was 6.1 (0.73) for brolucizumab 6mg and 6.6 (0.73) for aflibercept. Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001). The proportion of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF) at W96 in HAWK were 31% (p=0.0688) and 24% (p=0.0002) for brolucizumab 3mg and 6mg, and 37% for aflibercept, while in HARRIER it was 24% for brolucizumab 6mg (p<0.0001) and 39% for aflibercept. At W92 (the last DAA), there was a 45.4% and 38.6% probability for brolucizumab 6mg patients of maintaining on q12w in HAWK and HARRIER, respectively. Brolucizumab exhibited an overall well-tolerated safety profile. CONCLUSIONS Visual outcomes from W48 to W96 confirm the efficacy achieved at W48. Brolucizumab continued to demonstrate greater fluid resolution compared to aflibercept. The q12w potential for brolucizumab observed up to W48 was maintained up to W96.",2020,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","['neovascular age-related macular degeneration', 'eyes with neovascular AMD (nAMD) PARTICIPANTS: Treatment naive eyes with nAMD']","['brolucizumab 3mg', 'aflibercept', 'Aflibercept', 'brolucizumab', 'brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) [HARRIER', 'HAWK and HARRIER', 'Brolucizumab', 'brolucizumab 6mg (n=360) or aflibercept 2mg (n=360) [HAWK']","['Visual and anatomical parameters', 'proportion of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF', 'Mean change (LS mean ±SE) in BCVA (ETDRS letters', 'efficacy and safety', 'overall well-tolerated safety profile', 'Greater central subfield thickness (CST) reductions', 'Mean best corrected visual acuity (BCVA) change from baseline, proportion of patients on q12w, retinal thickness, retinal fluid changes, and safety', 'fluid resolution']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0324380', 'cui_str': 'Harrier dog'}, {'cui': 'C0325553', 'cui_str': 'Hawk'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0063613', 'cui_str': 'insulin resistance factor (uremia)'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",,0.0754469,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","[{'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': ''}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': ''}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ogura', 'Affiliation': ''}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': ''}, {'ForeName': 'Kinfemichael', 'Initials': 'K', 'LastName': 'Gedif', 'Affiliation': ''}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': ''}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': ''}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': ''}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.06.028'] 2387,31797680,Tumor burden and liver function in HCC patient selection for selective internal radiation therapy: SARAH post-hoc study.,"Aim: To determine whether a liver tumor burden ≤25% and well-preserved liver function (albumin-bilirubin grade 1) are appropriate criteria for identifying patients with unresectable hepatocellular carcinoma who may benefit from selective internal radiation therapy (SIRT) using 90 yttrium resin microspheres versus sorafenib. Patients & methods: Post-hoc analysis of patients in the intention-to-treat population of the SARAH trial (SIRT vs sorafenib) with ≤25% tumor burden and albumin-bilirubin grade 1. Primary end point: overall survival. Results: Median overall survival was 21.9 months (95% CI: 15.2-32.5, n = 37) with SIRT and 17.0 months (11.6-20.8, n = 48) with sorafenib (hazard ratios: 0.73; 95% CI: 0.44-1.21; p = 0.22). Conclusion: A combination of good liver function and low tumor burden may be relevant for selection of hepatocellular carcinoma patients for SIRT.",2020,"Median overall survival was 21.9 months (95% CI: 15.2-32.5, n = 37) with SIRT and 17.0 months (11.6-20.8, n = 48) with sorafenib (hazard ratios: 0.73; 95% CI: 0.44-1.21; p = 0.22). ","['Patients & methods: Post-hoc analysis of patients in the intention-to-treat population of the SARAH trial (SIRT vs sorafenib) with ≤25% tumor burden and albumin-bilirubin grade 1', 'hepatocellular carcinoma patients for SIRT', 'patients with unresectable hepatocellular carcinoma who may benefit from selective internal radiation therapy (SIRT) using 90 yttrium resin microspheres versus sorafenib']",['selective internal radiation therapy'],"['Median overall survival', 'Tumor burden and liver function', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}]","[{'cui': 'C0006098', 'cui_str': 'Brachytherapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",37.0,0.289328,"Median overall survival was 21.9 months (95% CI: 15.2-32.5, n = 37) with SIRT and 17.0 months (11.6-20.8, n = 48) with sorafenib (hazard ratios: 0.73; 95% CI: 0.44-1.21; p = 0.22). ","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Liverpool CR UK/NIHR Experimental Cancer Medicine Centre, University of Liverpool, Liverpool, L69 3BX, United Kingdom.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Hawkins', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, G12 8RZ, United Kingdom.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Vilgrain', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Paris Nord Val de Seine, Hôpital Beaujon, 92118 Clichy, France.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pereira', 'Affiliation': ""Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges-Pompidou, Unité d'épidémiologie et de Recherche Clinique, Paris, 75015 France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Chatellier', 'Affiliation': ""Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges-Pompidou, Unité d'épidémiologie et de Recherche Clinique, Paris, 75015 France.""}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ""Department of Medical Oncology, Guy's & St Thomas' NHS Foundation Trust, London, SE1 9RT, United Kingdom.""}]","Future oncology (London, England)",['10.2217/fon-2019-0658'] 2388,31809262,Hypnosis and learning: Pilot study on a group of students.,"Background Milton Erickson was the first to introduce hypnosis as a form of therapy during the post-war period. Numerous studies have evaluated the effects of hypnosis on memory, focusing principally on post-hypnotic amnesia, post-hypnotic hypermnesia, faux memories and learning growth. The aim of the present study was to determine if hypnosis can influence visual-spatial memory by increasing its performance and learning; to do this, we chose to utilise the Corsi Test (backward and forward). Methods Three hundred second-year students enrolled in the psychology faculty at the University of Catania were informed of the research and its modalities, and an e-mail was sent to inquire if they wanted to participate in the experiment. Seventy female students took part in the research; 10 were excluded because they presented a high risk of being influenced under hypnosis. The 60 subjects in the research sample were randomly divided into two groups: the Experimental Group and Control Group. The protocol prescribed administration of the Corsi Test at Time 0 (start) followed by a resting phase of 30 min. The hypnotic state was subsequently introduced, and the Corsi Test was administered again. Results The results of the Corsi Test for the Experimental Group showed statistically significant results (p<0.0004 and p<0.0001), while the results obtained in the Control Group did not show any significance. Conclusions These results led us to believe that hypnosis has the capacity to induce a nervous plasticity that supports learning of visual-spatial memory.",2019,"The results of the Corsi Test for the Experimental Group showed statistically significant results (p<0.0004 and p<0.0001), while the results obtained in the Control Group did not show any significance.","['60 subjects in the research sample', 'Methods Three hundred second-year students enrolled in the psychology faculty at the University of Catania were informed of the research and its modalities, and an e-mail was sent to inquire if they wanted to participate in the experiment', 'Seventy female students took part in the research; 10 were excluded because they presented a high risk of being influenced under hypnosis', 'a group of students']",[],[],"[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]",[],[],300.0,0.0222637,"The results of the Corsi Test for the Experimental Group showed statistically significant results (p<0.0004 and p<0.0001), while the results obtained in the Control Group did not show any significance.","[{'ForeName': 'Coco', 'Initials': 'C', 'LastName': 'Marinella', 'Affiliation': 'Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Ramaci', 'Initials': 'R', 'LastName': 'Tiziana', 'Affiliation': 'Department of Human and Social Sciences, School of Sport Sciences, Kore University, Enna, Italy.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Giuseppe', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Guglielmino', 'Initials': 'G', 'LastName': 'Antonino', 'Affiliation': 'Psychotherapist expert in clinical hypnosis, University of Catania, Catania, Italy.'}, {'ForeName': 'Giulia Di', 'Initials': 'GD', 'LastName': 'Gregorio', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Buscemi', 'Initials': 'B', 'LastName': 'Andrea', 'Affiliation': 'Horus Cooperativa Sociale, Ragusa, Italia.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2017-0082'] 2389,31825919,Cardiovascular Responses and Cardiac Work of Selected Daily Activities in Young Healthy Indian Participants.,"BACKGROUND Studies suggest that habitual daily activities may result in significant cardiovascular responses that might have implications for individuals with coronary artery disease. This study determined the cardiac work for various activities of daily living among healthy young participants. METHODS We evaluated cardiovascular responses in 42 young adults (21 male, 21 female) to graded activities. Subjects were divided into three groups. In each group, one light, one moderate, and one heavy activity were performed based on published METS. Cardiovascular responses were evaluated using impedance cardiography (BOMED Instruments, USA) and automated blood pressure monitor (Welch Allyn, USA). Cardiac work was computed as the double product (heart rate × systolic blood pressure) and triple product (systolic blood pressure × cardiac output [stroke volume × heart rate]). Perceived exertion was evaluated using Borg's scale. RESULTS There was high inter-individual variability in cardiovascular responses for each activity. There were, by and large, no gender differences across the activities. Cardiac work was significantly higher with heavy activities than light activities using both indices; however, the triple product showed greater discriminatory ability in evaluating differences in cardiac work across all categories of activities. CONCLUSION The data suggest a need to develop a compendium of cardiac work related to habitual activities to guide doctors and patients.",2020,"Cardiac work was significantly higher with heavy activities than light activities using both indices; however, the triple product showed greater discriminatory ability in evaluating differences in cardiac work across all categories of activities. ","['healthy young participants', '42 young adults (21 male, 21 female) to graded activities', 'Young Healthy Indian Participants', 'individuals with coronary artery disease']",[],"['cardiovascular responses', 'Perceived exertion', 'double product (heart rate × systolic blood pressure) and triple product (systolic blood pressure × cardiac output [stroke volume × heart rate', 'Cardiovascular responses', 'Cardiovascular Responses and Cardiac Work of Selected Daily Activities', 'impedance cardiography (BOMED Instruments, USA) and automated blood pressure monitor (Welch Allyn, USA']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]",[],"[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0007185', 'cui_str': 'Impedance Cardiography'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}]",42.0,0.0361441,"Cardiac work was significantly higher with heavy activities than light activities using both indices; however, the triple product showed greater discriminatory ability in evaluating differences in cardiac work across all categories of activities. ","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Fredrick', 'Affiliation': 'Department of Physiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry, India, drjeanfredrick@gmail.com.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Vaz', 'Affiliation': ""Department of Physiology, St. John's Medical College, Bengaluru, India.""}]",Complementary medicine research,['10.1159/000504794'] 2390,31828504,Impact of recruitment and retention on all-cause mortality in a large all-comers randomised controlled trial: insights from the GLOBAL LEADERS trial.,"OBJECTIVE Recruitment and retention in trials may bias the results and subsequently complicate their interpretation and validity. The aim of this study is to evaluate the impact of recruitment and retention on all-cause mortality in a large all-comers trial. METHODS The recruitment rate in each investigating center of the GLOBAL LEADERS trial was assessed and the 130 centers were subdivided into low and high recruiters according to the median, with all-cause mortality then compared between the two groups. Vital status was obtained from public records in patients with incomplete follow-up. RESULTS The trial randomized 15,991 (7.86%) of 203,483 eligible patients with percutaneous coronary intervention during the recruitment period, of whom 15,267 (95.47%) completed follow-up, 23 (0.14%) patients withdrew consent and formally requested to be deleted from the database; 183 (1.14%) withdrew consent but only objected to future data collection; 303 (1.89%) discontinued the study; and 215 (1.34%) were lost to follow-up. Vital status was finally obtained in all but 31 patients (99.81%). Patients from low recruiters had a significantly lower all-cause mortality than high ones (2.26% vs. 3.24%; hazard ratio: 0.69; 95% confidence interval: 0.55-0.87; p = 0.002). There was a significant difference in all-cause mortality among the incomplete follow-up groups (log-rank p < 0.001) with a significantly higher mortality in the 183 patients who withdrew consent than those who completed follow-up (7.38% vs. 2.99%, p = 0.002). CONCLUSIONS Recruitment and retention significantly impacted all-cause mortality. Search for vital status through public domains is of paramount importance in the interpretation and validity of large clinical trials.",2020,Patients from low recruiters had a significantly lower all-cause mortality than high ones (2.26% vs. 3.24%; hazard ratio: 0.69; 95% confidence interval: 0.55-0.87; p = 0.002).,"['203,483 eligible patients with percutaneous coronary intervention during the recruitment period, of whom 15,267 (95.47%) completed follow-up, 23 (0.14%) patients withdrew consent and formally requested to be deleted from the database; 183 (1.14%) withdrew consent but only objected to future data collection; 303 (1.89%) discontinued the study; and 215 (1.34%) were lost to follow-up']",[],"['cause mortality', 'mortality', 'Vital status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517430', 'cui_str': '0.14'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C4517492', 'cui_str': '1.14'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",15991.0,0.155884,Patients from low recruiters had a significantly lower all-cause mortality than high ones (2.26% vs. 3.24%; hazard ratio: 0.69; 95% confidence interval: 0.55-0.87; p = 0.002).,"[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun-Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Faculty of Medicine and Life Sciences, Jessa Ziekenhuis, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Liebetrau', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imelda Ziekenhuis, Bonheiden, Belgium.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrario', 'Affiliation': 'UOC Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Zurakowski', 'Affiliation': 'American Heart of Poland, Ustroń, Poland.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Medical School, Wilhelminen Hospital, and Sigmund Freud University, Vienna, Austria.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'American Heart of Poland, Ustroń, Poland.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Ospedale S. Donato, Arezzo, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tumscitz', 'Affiliation': 'University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Żmudka', 'Affiliation': 'Department of Interventional Cardiology, Faculty of Medicine, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Vrolix', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Petrov', 'Affiliation': 'City Clinic, Sofia, Bulgaria.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heartand, Thorax Center, University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Faculty of Medicine and Life Sciences, Jessa Ziekenhuis, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-019-01585-w'] 2391,31893985,Atrial Cardiopathy and Nonstenosing Large Artery Plaque in Patients With Embolic Stroke of Undetermined Source.,"Background and Purpose- Atrial cardiopathy and atherosclerotic plaque are two potential mechanisms underlying embolic strokes of undetermined source (ESUS). The relationship between these two mechanisms among ESUS patients remains unclear. A better understanding of their association may inform targeted secondary prevention strategies. Methods- We examined the association between atrial cardiopathy and atherosclerotic plaque in the NAVIGATE ESUS trial (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial Versus ASA to Prevent Embolism in Embolic Stroke of Undetermined Source), which enrolled 7213 patients with recent ESUS during 2014 to 2017. For this analysis, we included patients with data on left atrial dimension, location of brain infarction, and cervical large artery plaque. The variables of primary interest were left atrial diameter and cervical plaque ipsilateral to brain infarction. Secondary markers of atrial cardiopathy were premature atrial contractions on Holter monitoring and newly diagnosed atrial fibrillation. For descriptive purposes, left atrial enlargement was defined as ≥4.7 cm. Multivariable logistic regression was used to examine the association between atrial cardiopathy markers and ipsilateral plaque after adjustment for age, sex, body mass index, hypertension, diabetes mellitus, current smoking, and hyperlipidemia. Results- Among 3983 eligible patients, 235 (5.9%) had left atrial enlargement, 939 (23.6%) had ipsilateral plaque, and 94 (2.4%) had both. Shared risk factors for left atrial enlargement and ipsilateral plaque were male sex, white race, hypertension, tobacco use, and coronary artery disease. Despite shared risk factors, increasing left atrial dimension was not associated with ipsilateral plaque after adjustment for covariates (odds ratio per cm, 1.1 [95% CI, 1.0-1.2]; P =0.08). We found no consistent associations between secondary markers of atrial cardiopathy and ipsilateral plaque. Conclusions- In a large population of patients with ESUS, we did not observe a notable association between atrial cardiopathy and atherosclerotic plaque, and few patients had both conditions. These findings suggest that atrial cardiopathy and atherosclerotic plaque may be distinct, nonoverlapping risk factors for stroke among ESUS patients.",2020,"Despite shared risk factors, increasing left atrial dimension was not associated with ipsilateral plaque after adjustment for covariates (odds ratio per cm, 1.1 [95% CI, 1.0-1.2]; P =0.08).","['3983 eligible patients, 235 (5.9%) had left atrial enlargement, 939 (23.6%) had ipsilateral plaque, and 94 (2.4%) had both', '7213 patients with recent ESUS during 2014 to 2017', 'patients with data on left atrial dimension, location of brain infarction, and cervical large artery plaque', 'Patients With Embolic Stroke of Undetermined Source']","['Methods', 'Conclusions', ' and Purpose']","['left atrial diameter and cervical plaque ipsilateral to brain infarction', 'premature atrial contractions on Holter monitoring and newly diagnosed atrial fibrillation', 'left atrial dimension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232309', 'cui_str': 'Left atrial hypertrophy by EKG'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0751955', 'cui_str': 'Brain Infarct'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0751955', 'cui_str': 'Brain Infarct'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",7213.0,0.0280907,"Despite shared risk factors, increasing left atrial dimension was not associated with ipsilateral plaque after adjustment for covariates (odds ratio per cm, 1.1 [95% CI, 1.0-1.2]; P =0.08).","[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'From the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, NY (H.K.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Internal Medicine, University of Thessaly, Larissa, Greece (G.N.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gladstone', 'Affiliation': 'Division of Neurology and Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre and Sunnybrook Research Institute, Toronto, ON, Canada (D.J.G.).'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Perera', 'Affiliation': 'Department of Medicine-Neurology, Population Health Research Institute, McMaster University, Toronto, ON, Canada (K.P., A.S., M.S., R.G.H.).'}, {'ForeName': 'Risto O', 'Initials': 'RO', 'LastName': 'Roine', 'Affiliation': 'Division of Clinical Neurosciences, University of Turku and Turku University Hospital, Finland (R.O.R.).'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Meseguer', 'Affiliation': 'Neurology Service, Bichat Hospital, Paris, France (E.M.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Department of Medicine-Neurology, Population Health Research Institute, McMaster University, Toronto, ON, Canada (K.P., A.S., M.S., R.G.H.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Research and Development, Pharmaceuticals, Bayer US LLC, Whippany, NJ (S.D.B.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M.).'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine-Neurology, Population Health Research Institute, McMaster University, Toronto, ON, Canada (K.P., A.S., M.S., R.G.H.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Division of Cardiology, Population Health Research Institute, McMaster University, Hamilton, ON, Canada (S.J.C., J.S.H.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine-Neurology, Population Health Research Institute, McMaster University, Toronto, ON, Canada (K.P., A.S., M.S., R.G.H.).'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Division of Cardiology, Population Health Research Institute, McMaster University, Hamilton, ON, Canada (S.J.C., J.S.H.).'}]",Stroke,['10.1161/STROKEAHA.119.028154'] 2392,29699895,Association between increased serum d-serine and cognitive gains induced by intensive cognitive training in schizophrenia.,"Neuroscience-guided cognitive training induces significant improvement in cognition in schizophrenia subjects, but the biological mechanisms associated with these changes are unknown. In animals, intensive cognitive activity induces increased brain levels of the NMDA-receptor co-agonist d-serine, a molecular system that plays a role in learning-induced neuroplasticity and that may be hypoactive in schizophrenia. Here, we investigated whether training-induced gains in cognition were associated with increases in serum d-serine in outpatients with schizophrenia. Ninety patients with schizophrenia and 53 healthy controls were assessed on baseline serum d-serine, l-serine, and glycine. Schizophrenia subjects performed neurocognitive tests and were assigned to 50 h of either cognitive training of auditory processing systems (N = 47) or a computer games control condition (N = 43), followed by reassessment of cognition and serum amino acids. At study entry, the mean serum d-serine level was significantly lower in schizophrenia subjects vs. healthy subjects, while the glycine levels were significantly higher. There were no significant changes in these measures at a group level after the intervention. However, in the active training group, increased d-serine was significantly and positively correlated with improvements in global cognition and in Verbal Learning. No such associations were observed in the computer games control subjects, and no such associations were found for glycine. d-Serine may be involved in the neurophysiologic changes induced by cognitive training in schizophrenia. Pharmacologic strategies that target d-serine co-agonism of NMDA-receptor functioning may provide a mechanism for enhancing the behavioral effects of intensive cognitive training.",2019,"At study entry, the mean serum d-serine level was significantly lower in schizophrenia subjects vs. healthy subjects, while the glycine levels were significantly higher.","['outpatients with schizophrenia', 'schizophrenia subjects', 'Ninety patients with schizophrenia and 53 healthy controls', 'Schizophrenia subjects']","['intensive cognitive training', 'cognitive training of auditory processing systems (N\u202f=\u202f47) or a computer games control condition (N\u202f=\u202f43), followed by reassessment of cognition and serum amino acids', 'Neuroscience-guided cognitive training']","['glycine levels', 'd-serine', 'mean serum d-serine level', 'brain levels', 'global cognition and in Verbal Learning']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0587180', 'cui_str': 'Measurement of serum amino acid level'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C1445999', 'cui_str': 'Urine glycine measurement'}, {'cui': 'C1880218', 'cui_str': 'serine, D-'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}]",90.0,0.0140283,"At study entry, the mean serum d-serine level was significantly lower in schizophrenia subjects vs. healthy subjects, while the glycine levels were significantly higher.","[{'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Panizzutti', 'Affiliation': 'W.M. Keck Foundation Center for Integrative Neurosciences, 675 Nelson Rising Lane, San Francisco, CA, USA; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, CCS, Cidade Universitaria, Rio de Janeiro, RJ, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Av. Venceslau Braz, 71, Rio de Janeiro, RJ, Brazil; Department of Psychiatry, UCSF School of Medicine, 982 Mission St, San Francisco, CA, USA. Electronic address: rogerio@icb.ufrj.br.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, 2312 S 6th St., Minneapolis, MN, USA.'}, {'ForeName': 'Coleman', 'Initials': 'C', 'LastName': 'Garrett', 'Affiliation': 'Department of Psychiatry, UCSF School of Medicine, 982 Mission St, San Francisco, CA, USA.'}, {'ForeName': 'Wai Hong', 'Initials': 'WH', 'LastName': 'Man', 'Affiliation': 'Department of Psychiatry, UCSF School of Medicine, 982 Mission St, San Francisco, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Sena', 'Affiliation': 'Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, CCS, Cidade Universitaria, Rio de Janeiro, RJ, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Av. Venceslau Braz, 71, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Madeira', 'Affiliation': 'Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, CCS, Cidade Universitaria, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, 2312 S 6th St., Minneapolis, MN, USA.'}]",Schizophrenia research,['10.1016/j.schres.2018.04.011'] 2393,30302940,Pre-hospital administration of ticagrelor in diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty: A sub-analysis of the ATLANTIC trial.,"OBJECTIVE We investigated, in the contemporary era of ST-elevation myocardial infarction (STEMI) treatment, the influence of diabetes mellitus (DM) on cardiovascular outcomes, and whether pre-hospital administration of ticagrelor may affect these outcomes in a subgroup of STEMI patients with DM. BACKGROUND DM patients have high platelet reactivity and a prothrombotic condition which highlight the importance of an effective antithrombotic regimen in this high-risk population. METHODS In toal 1,630 STEMI patients enrolled in the ATLANTIC trial who underwent primary percutaneous coronary intervention (PCI) were included. Multivariate analysis was used to explore the association of DM with outcomes and potential treatment-by-diabetes interaction was tested. RESULTS A total of 214/1,630 (13.1%) patients had DM. DM was an independent predictor of poor myocardial reperfusion as reflected by less frequent ST-segment elevation resolution (≥70%) after PCI (OR 0.59, 95% CI 0.43-0.82, P < 0.01) and was an independent predictor of the composite 30-day outcomes of death/new myocardial infarction (MI)/urgent revascularization/definite stent thrombosis (ST) (OR 2.80, 95% CI 1.62-4.85, P < 0.01), new MI or definite acute ST (OR 2.46, 95% CI 1.08-5.61, P = 0.03), and definite ST (OR 10.00, 95% CI 3.54-28.22, P < 0.01). No significant interaction between pre-hospital ticagrelor vs in-hospital ticagrelor administration and DM was present for the clinical, electrocardiographic and angiographic outcomes as well as for thrombolysis in myocardial infarction major bleeding. CONCLUSIONS DM remains independently associated with poor myocardial reperfusion and worse 30-day clinical outcomes. No significant interaction was found between pre-hospital vs in-hospital ticagrelor administration and DM status. Further approaches for the treatment of DM patients are needed. CLINICAL TRIAL REGISTRATION clinicaltrials.gov identifier: NCT01347580.",2019,"DM was an independent predictor of poor myocardial reperfusion as reflected by less frequent ST-segment elevation resolution (≥70%) after PCI (OR 0.59, 95% CI 0.43-0.82, P < 0.01) and was an independent predictor of the composite 30-day outcomes of death/new myocardial infarction (MI)/urgent revascularization/definite stent thrombosis (ST) (OR 2.80, 95% CI 1.62-4.85, P < 0.01), new MI or definite acute ST (OR","['diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty', 'In toal 1,630 STEMI patients enrolled in the ATLANTIC trial who underwent primary percutaneous coronary intervention (PCI) were included']",['ticagrelor'],"['frequent ST-segment elevation resolution', 'new MI or definite acute ST (OR', 'death/new myocardial infarction (MI)/urgent revascularization/definite stent thrombosis (ST']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",1630.0,0.152211,"DM was an independent predictor of poor myocardial reperfusion as reflected by less frequent ST-segment elevation resolution (≥70%) after PCI (OR 0.59, 95% CI 0.43-0.82, P < 0.01) and was an independent predictor of the composite 30-day outcomes of death/new myocardial infarction (MI)/urgent revascularization/definite stent thrombosis (ST) (OR 2.80, 95% CI 1.62-4.85, P < 0.01), new MI or definite acute ST (OR","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fabris', 'Affiliation': 'Cardiology Department, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': ""Van't Hof"", 'Affiliation': 'Cardiology Department, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'SAMU 93 Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology B, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian Heart Research Centre, Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular and Neurological Department, Azienda Ospedaliera Arezzo, Arezzo, Italy.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Heart Disease Institute, Hospital Universitario de Bellvitge, University of Barcelona, Spain.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Chettibi', 'Affiliation': 'Centre Hospito-universitaire Frantz Fanon, Blida, Algeria.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hammett', 'Affiliation': ""Department of Cardiology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen hospital and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Janzon', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Cantor', 'Affiliation': 'Southlake Regional Health Centre, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'Sorbonne Université, ACTION Study Group, Hospital Pitie-Salpetriere (AP-HP), Paris, France.'}, {'ForeName': 'Abdourahmane', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'Hospital Lariboisiere, ACTION Study Group, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Hospital Lariboisiere, ACTION Study Group, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, Hospital Pitie-Salpetriere (AP-HP), Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.27921'] 2394,32164597,"Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa.","BACKGROUND Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement (QI) intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa. METHODS A three-month intervention comprised of six QI mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1. RESULTS Improvements in some growth monitoring indicators were achieved in intervention clinics compared to control clinics, including measuring the length of the baby (77% vs 63%; p = 0.001) and health workers asking mothers about the child's feeding (74% vs 67%; p = 0.003), but the proportion of mothers who received feeding advice remained unchanged (38% vs 35%; p = 0.48). Significantly more mothers in the intervention group were asked about their baby's health (44% vs 36%; p = 0.001), and completeness of record keeping improved (40% vs 26%; I = < 0.0001). Discussions with the mother about some maternal health services improved: significantly more mothers in the intervention group were asked about HIV (26.5% vs 19.5%; p = 0.009) and family planning (33.5% vs 19.5%; p <  0.001), but this did not result in additional services being provided to mothers at the clinic visit. CONCLUSION This robust evaluation shows significant improvements in coverage of some services, but the QI intervention was unable to achieve the substantial changes required to provide a comprehensive package of services to all mothers and children. We suggest the QI process be adapted to complex under-resourced health systems, building on the strengths of this approach, to provide workable health systems strengthening solutions for scalable implementation. TRIAL REGISTRATION ClinicalTrials.gov NCT04278612. Date of Registration: February 19, 2020. Retrospectively registered.",2020,"Significantly more mothers in the intervention group were asked about their baby's health (44% vs 36%; p = 0.001), and completeness of record keeping improved (40% vs 26%; I = < 0.0001).","['27 clinics in four sub-districts using a stepped-wedge design', 'primary health care facilities in South Africa', 'for mothers and children', 'Five waves of data collection were conducted in all participating clinics between December 2016-February 2017']","['quality improvement intervention', 'six QI mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services']","['feeding advice', 'length of the baby', 'integration of maternal and child health and HIV services', 'completeness of record keeping']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]",,0.0707622,"Significantly more mothers in the intervention group were asked about their baby's health (44% vs 36%; p = 0.001), and completeness of record keeping improved (40% vs 26%; I = < 0.0001).","[{'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Haskins', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, 4th Floor, George Campbell Building, Howard College Campus, Durban, South Africa.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chiliza', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, 4th Floor, George Campbell Building, Howard College Campus, Durban, South Africa. jchiliza@bu.edu.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'Institute for Healthcare Improvement, 53 State Street, Boston, MA, 02019, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Connolly', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, 4th Floor, George Campbell Building, Howard College Campus, Durban, South Africa.'}, {'ForeName': 'Sifiso', 'Initials': 'S', 'LastName': 'Phakathi', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, 4th Floor, George Campbell Building, Howard College Campus, Durban, South Africa.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Feeley', 'Affiliation': 'UNICEF South Africa, Equity House, 659 Pienaar Street, Pretoria, South Africa.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Horwood', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, 4th Floor, George Campbell Building, Howard College Campus, Durban, South Africa.'}]",BMC public health,['10.1186/s12889-020-8397-2'] 2395,31407320,The impact of SOCS1 mutations in diffuse large B-cell lymphoma.,"Mutations in SOCS1 are frequent in primary mediastinal B-cell lymphoma and classical Hodgkin lymphoma. In the latter, SOCS1 mutations affect the length of the encoded protein (major mutations) and are associated with shorter patient survival. Two independent studies examined the prognostic impact of SOCS1 mutations in diffuse large B-cell lymphoma (DLBCL) and showed differing results. This may be due to the small number of included patients, the heterogeneity of patients' demographics and the distinct treatment schemes in these studies. To overcome the size limitations of these previous studies, we assessed SOCS1 mutations in the RICOVER-60 cohort. The cohort uniformly consists of elderly patients (aged 61-80 years) treated with the CHOP-14 scheme (cyclophosphamide, hydroxydaunorubicin, vincristine, prednisolone at 14-day intervals) with or without an additional rituximab treatment. Patient outcomes were analysed with regard to overall SOCS1 mutation frequency, major and minor mutations and a novel impact-based classifier - against the treatment modalities. Patients harbouring putative pathogenic SOCS1 mutations showed significant reduced overall survival within the CHOP plus rituximab group. Hence, putative pathogenic SOCS1 mutations seem to efface the beneficial effect of the therapeutic CD20 antibody. Comparing published data of whole exome and transcriptome sequencing of a large DLBCL cohort confirmed that predicted deleterious SOCS1 mutations forecast pre-eminent survival in early onset DLBCL.",2019,Patients harbouring putative pathogenic SOCS1 mutations showed significant reduced overall survival within the CHOP plus rituximab group.,"['Patients harbouring putative pathogenic SOCS1 mutations', 'diffuse large B-cell lymphoma', 'elderly patients (aged 61-80\xa0years) treated with the']","['CHOP-14 scheme (cyclophosphamide, hydroxydaunorubicin, vincristine, prednisolone at 14-day intervals) with or without an additional rituximab treatment']","['overall SOCS1 mutation frequency, major and minor mutations and a novel impact-based classifier - against the treatment modalities', 'overall survival', 'patient survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0546861', 'cui_str': 'Doxorubicin hydrochloride'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3178846', 'cui_str': 'Mutation Frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0414073,Patients harbouring putative pathogenic SOCS1 mutations showed significant reduced overall survival within the CHOP plus rituximab group.,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mellert', 'Affiliation': 'Institute of Pathology, University Hospital, Ulm, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Institute of Pathology, University Hospital, Ulm, Germany.'}, {'ForeName': 'Jochen K', 'Initials': 'JK', 'LastName': 'Lennerz', 'Affiliation': 'Institute of Pathology, University Hospital, Ulm, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Lüdeke', 'Affiliation': 'Institute of Human Genetics, University Hospital, Ulm, Germany.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Staiger', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Kreuz', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Löffler', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Trümper', 'Affiliation': 'Georg-August Universität, Göttingen, Germany.'}, {'ForeName': 'Alfred C', 'Initials': 'AC', 'LastName': 'Feller', 'Affiliation': 'Haematopathologie Luebeck, Luebeck, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Hartmann', 'Affiliation': 'Senckenberg Institute of Pathology, Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Martin-Leo', 'Initials': 'ML', 'LastName': 'Hansmann', 'Affiliation': 'Senckenberg Institute of Pathology, Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Institute of Pathology, Universitätsklinikum Schleswig-Holstein, Berlin, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Stein', 'Affiliation': 'Pathodiagnostik Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, Universität Würzburg and Comprehensive Cancer Centre Mainfranken, Würzburg, Germany.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Ott', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Ziepert', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Möller', 'Affiliation': 'Institute of Pathology, University Hospital, Ulm, Germany.'}]",British journal of haematology,['10.1111/bjh.16147'] 2396,31552797,Weight-related genomic information and provider communication approach: looking through the lens of patient race.,"Aim: This report explores the process of weight-related genomic information provision considering patient race as an important potential moderator of patient response. Methods: Health beliefs and perceived stigma were assessed following provision of genomic (versus behavioral) information by a virtual reality-based physician using either a supportive or directive communication style. Participants included 168 women with overweight. Results: Genomic explanations, combined with supportive communication, resulted in some improved health behavior-related and interpersonal outcomes for white patients, but not black participants. Black participants, on average, did not have diminished outcomes when provided with genomic information. Conclusion: Genomic communications may elicit more positive interpersonal responses than behavioral explanations among both majority and minority populations, but these effects may be moderated by patient race.",2019,"Black participants, on average, did not have diminished outcomes when provided with genomic information. ","['Black participants', 'Participants included 168 women with overweight']",[],"['positive interpersonal responses', 'health behavior-related and interpersonal outcomes']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",168.0,0.104094,"Black participants, on average, did not have diminished outcomes when provided with genomic information. ","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Boland', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute 31 Center Drive, B1B36, Bethesda, MD 20892, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Street', 'Affiliation': 'Department of Communication, Texas A&M University, 4234 TAMU, College Station, TX 77843-4234, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Persky', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute 31 Center Drive, B1B36, Bethesda, MD 20892, USA.'}]",Personalized medicine,['10.2217/pme-2018-0148'] 2397,31068395,Developing Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program in a Latino-Based Community Health Center.,"INTRODUCTION Colon cancer is the second leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. One factor thought to contribute to the low screening rate is the difficulty Latinos encounter in understanding health information, and therefore in taking appropriate health action. Therefore, we used Boot Camp Translation (BCT), a patient engagement approach, to engage Latino stakeholders (ie, patients, clinic staff) in refining the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical testing (FIT) program. METHODS Patient participants were Latino, ages 50 to 75 years, able to speak English or Spanish, and willing to participate in the in-person kickoff meeting and follow-up phone calls over a 3-month period. We held separate BCT sessions for English- and Spanish-speaking participants. As part of the in-person meetings, a bilingual colon cancer expert presented on colon health and screening messages and BCT facilitators led interactive sessions where participants reviewed materials and reminder messages in various modalities (eg, letter, text). Participants considered what information about colon cancer screening was important, the best methods to share these messages, and the timing and frequency with which these messages should be delivered to patients to encourage FIT completion. We used follow-up phone calls to iteratively refine materials developed based on key learnings from the in-person meeting. RESULTS Twenty-five adults participated in the in-person sessions (English [n = 12]; Spanish [n = 13]). Patient participants were primarily enrolled in Medicaid/uninsured (76%) and had annual household incomes less than $20,000 (67%). Key themes distilled from the sessions included increasing awareness that screening can prevent colon cancer, stressing the urgency of screening, emphasizing the motivating influence of family, and using personalized messages from the practice such as 'I' or 'we' statements in letters or automated phone call reminders delivered by humans. Participants in both sessions noted the importance of receiving an automated or live alert before a FIT kit is mailed and a reminder within 2 weeks of FIT kit mailing. DISCUSSION Using BCT, we successfully incorporated participant feedback to adapt culturally relevant health messages to promote FIT testing among Latino patients served by community clinics. Materials will be tested in the larger Participatory Research to Advance Colon Cancer Prevention (PROMPT) trial.",2019,"Key themes distilled from the sessions included increasing awareness that screening can prevent colon cancer, stressing the urgency of screening, emphasizing the motivating influence of family, and using personalized messages from the practice such as 'I' or 'we' statements in letters or automated phone call reminders delivered by humans.","['Patient participants were primarily enrolled in Medicaid/uninsured (76%) and had annual household incomes less than $20,000 (67', 'Patient participants were Latino, ages 50 to 75 years, able to speak English or Spanish, and willing to participate in the in-person kickoff meeting and follow-up phone calls over a 3-month period', 'Twenty-five adults participated in the in-person sessions (English [n = 12]; Spanish [n = 13', 'Latino patients served by community clinics']","['Boot Camp Translation (BCT', 'refining the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical testing (FIT) program']",['importance of receiving an automated or live alert'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0564215', 'cui_str': 'Able to speak'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}]","[{'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0554837', 'cui_str': 'Screening for malignant neoplasm of colon'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}]",25.0,0.0323414,"Key themes distilled from the sessions included increasing awareness that screening can prevent colon cancer, stressing the urgency of screening, emphasizing the motivating influence of family, and using personalized messages from the practice such as 'I' or 'we' statements in letters or automated phone call reminders delivered by humans.","[{'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC). jamie.h.thompson@kpchr.org.'}, {'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Davis', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}, {'ForeName': 'LeAnn', 'Initials': 'L', 'LastName': 'Michaels', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Rivelli', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Castillo', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}, {'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Younger', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}, {'ForeName': 'Sacha L', 'Initials': 'SL', 'LastName': 'Reich', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}, {'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'From the Center for Health Research, Kaiser Permanente Northwest, Portland, OR (JHT, JSR, SLR, GDC); Oregon Rural Practice-based Research Network, Oregon Health & Science University, Portland (MMD, LM); AltaMed Health Services, Los Angeles, CA (MLC, BMY, MC).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.03.180026'] 2398,32576275,Efficacy of a short-term residential smoking cessation therapy versus standard outpatient group therapy ('START-Study'): study protocol of a randomized controlled trial.,"BACKGROUND In Germany, evidence-based outpatient smoking cessation therapies are widely available. Long-term abstinence rates, however, are limited. Studies suggest that short-term residential therapy enables a higher level of environmental control, more intense contact and greater support among patients and from therapists, which could result in higher abstinence rates. The aim of the current START-study is to investigate the long-term efficacy of a short-term residential therapy exclusively for smoking cessation, conducted by a mobile team of expert therapists. METHODS A randomized controlled trial (RCT) is conducted to examine the efficacy of residential behavior therapeutic smoking cessation therapy compared to standard outpatient behavior therapeutic smoking cessation group therapy. Adult smokers consuming 10 or more cigarettes per day, who are willing to stop smoking, are randomized in a ratio of 1:1 between therapy groups. The primary endpoint is sustained abstinence for 6-month and 12-month periods. Secondary endpoints include smoking status after therapy, 7-day point abstinence after the 6-month and 12-month follow-ups, level of physical dependence, cost-effectiveness, use of nicotine replacement products, health-related quality of life, self-efficacy expectation for tobacco abstinence, motivational and volitional determinants of behavior change, self-reported depressive symptom severity, adverse events and possible side effects. Assessments will take place at baseline, post-therapy, and at 6-month and 12-month intervals after smoking cessation. DISCUSSION There is a high demand for long-term effective smoking cessation therapies. This study represents the first prospective RCT to examine the long-term efficacy of a residential smoking cessation therapy program compared to standard outpatient group therapy as an active control condition. The residential therapeutic concept may serve as a new model to substantially enhance future cessation therapies and improve the understanding of therapeutic impact factors on tobacco abstinence. Utilizing a mobile team, the model could be applied efficiently to medical centers that do not have permanent and trained personnel for smoking cessation at their disposal. TRIAL REGISTRATION German Register for Clinical Trials (Deutsches Register für Klinische Studien), DRKS00013466. Retrospectively registered on 1 April 2019. https://www.drks.de/drks_web/navigate.do?navigationId=start.",2020,"Studies suggest that short-term residential therapy enables a higher level of environmental control, more intense contact and greater support among patients and from therapists, which could result in higher abstinence rates.","['Adult smokers consuming 10 or more cigarettes per day, who are willing to stop smoking']","['short-term residential smoking cessation therapy', 'residential smoking cessation therapy program', 'residential behavior therapeutic smoking cessation therapy']","['smoking status after therapy, 7-day point abstinence after the 6-month and 12-month follow-ups, level of physical dependence, cost-effectiveness, use of nicotine replacement products, health-related quality of life, self-efficacy expectation for tobacco abstinence, motivational and volitional determinants of behavior change, self-reported depressive symptom severity, adverse events and possible side effects', 'sustained abstinence for 6-month and 12-month periods']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0278080', 'cui_str': 'Physical addiction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3179143', 'cui_str': 'Nicotine Replacement Products'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0461374,"Studies suggest that short-term residential therapy enables a higher level of environmental control, more intense contact and greater support among patients and from therapists, which could result in higher abstinence rates.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Dickreuter', 'Affiliation': 'Comprehensive Cancer Center, Prevention Team CMPT, University Medical Center Freiburg, Elsässerstraße 2, 79110, Freiburg, Germany. Jonas.dickreuter@uniklinik-freiburg.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schmoor', 'Affiliation': 'Clinical Trials Unit, Faculty of Medicine and Medical Center, University Medical Center Freiburg, Elsässerstraße 2, 79110 Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Bengel', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, Albert-Ludwigs-University Freiburg, Engelberger Straße 41, 79085, Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jähne', 'Affiliation': 'Rhein-Jura Klinik, Schneckenhalde 13, 79713, Bad Säckingen, Germany.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Leifert', 'Affiliation': 'Comprehensive Cancer Center, Prevention Team CMPT, University Medical Center Freiburg, Elsässerstraße 2, 79110, Freiburg, Germany.'}]",Trials,['10.1186/s13063-020-04253-x'] 2399,32576287,"A randomized single-dose, two-period crossover bioequivalence study of two fixed-dose Paracetamol/Orphenadrine combination preparations in healthy volunteers under fasted condition.","BACKGROUND Paracetamol/Orphenadrine is a fixed dose combination containing 35 mg orphenadrine and 450 mg paracetamol. It has analgesic and muscle relaxant properties and is widely available as generics. This study is conducted to investigate the relative bioavailability and bioequivalence between one fixed dose paracetamol/orphenadrine combination test preparation and one fixed dose paracetamol/orphenadrine combination reference preparation in healthy volunteers under fasted condition for marketing authorization in Malaysia. METHOD This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2-period crossover study with a washout period of 7 days. Paracetamol/Orphenadrine tablets were administered after a 10-h fast. Blood samples for pharmacokinetic analysis were collected at scheduled time intervals prior to and up to 72 h after dosing. Blood samples were centrifuged, and separated plasma were kept frozen (- 15 °C to - 25 °C) until analysis. Plasma concentrations of orphenadrine and paracetamol were quantified using liquid-chromatography-tandem mass spectrometer using diphenhydramine as internal standard. The pharmacokinetic parameters AUC 0-∞ , AUC 0-t and C max were determined using plasma concentration time profile for both preparations. Bioequivalence was assessed according to the ASEAN guideline acceptance criteria for bioequivalence which is the 90% confidence intervals of AUC 0-∞ , AUC 0-t and C max ratio must be within the range of 80.00-125.00%. RESULTS There were 28 healthy subjects enrolled, and 27 subjects completed this trial. There were no significant differences observed between the AUC 0-∞ , AUC 0-t and C max of both test and reference preparations in fasted condition. The 90% confidence intervals for the ratio of AUC 0-t (100.92-111.27%), AUC 0-∞ (96.94-108.08%) and C max (100.11-112.50%) for orphenadrine (n = 25); and AUC 0-t (94.29-101.83%), AUC 0-∞ (94.77-101.68%) and C max (87.12-101.20%) for paracetamol (n = 27) for test preparation over reference preparation were all within acceptable bioequivalence range of 80.00-125.00%. CONCLUSION The test preparation is bioequivalent to the reference preparation and can be used interchangeably. TRIAL REGISTRATION NMRR- 17-1266-36,001; registered and approved on 12 September 2017.",2020,"There were no significant differences observed between the AUC 0-∞ , AUC 0-t and C max of both test and reference preparations in fasted condition.","['healthy volunteers under fasted condition', 'healthy volunteers under fasted condition for marketing authorization in Malaysia', '28 healthy subjects enrolled, and 27 subjects completed this trial']","['diphenhydramine', 'Orphenadrine tablets', 'Paracetamol/Orphenadrine combination preparations', 'paracetamol/orphenadrine', 'Paracetamol', 'paracetamol', 'Paracetamol/Orphenadrine', 'paracetamol/orphenadrine combination reference preparation', 'orphenadrine and 450\u2009mg paracetamol']","['AUC 0-∞ , AUC 0-t and C max', 'relative bioavailability and bioequivalence', 'Plasma concentrations of orphenadrine and paracetamol', 'ratio of AUC 0-t', 'pharmacokinetic parameters AUC 0-∞ , AUC 0-t and C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0029309', 'cui_str': 'Orphenadrine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3844104', 'cui_str': '450'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029309', 'cui_str': 'Orphenadrine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",28.0,0.0943713,"There were no significant differences observed between the AUC 0-∞ , AUC 0-t and C max of both test and reference preparations in fasted condition.","[{'ForeName': 'Kit Yee', 'Initials': 'KY', 'LastName': 'Cheah', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia. kityeecheah@hotmail.com.'}, {'ForeName': 'Kar Yee', 'Initials': 'KY', 'LastName': 'Mah', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Lai Hui', 'Initials': 'LH', 'LastName': 'Pang', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Shi Min', 'Initials': 'SM', 'LastName': 'Ng', 'Affiliation': 'Clinical Research Ward, Clinical Trial Unit, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Hospital Ampang, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Jia Woei', 'Initials': 'JW', 'LastName': 'Wong', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}, {'ForeName': 'Siew Siew', 'Initials': 'SS', 'LastName': 'Tan', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}, {'ForeName': 'Hong Zhe', 'Initials': 'HZ', 'LastName': 'Tan', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}, {'ForeName': 'Kah Hay', 'Initials': 'KH', 'LastName': 'Yuen', 'Affiliation': 'Pharmacy-Attest Research Sdn Bhd BA/BE Centre, George Town, Pulau Pinang, Malaysia.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00416-3'] 2400,32576297,Comparison of whole egg vs. egg white ingestion during 12 weeks of resistance training on skeletal muscle regulatory markers in resistance-trained men.,"Eggs are considered a high-quality protein source for its complete amino acid profile and digestibility. Therefore, this study aimed to compare the effects of the whole egg (WE) vs. egg white (EW) ingestion during 12 weeks of resistance training (RT) on skeletal muscle regulatory markers and body composition in resistance-trained men. Thirty resistance-trained men (24.6 ± 2.7 years) were randomly assigned into a WE + RT (WER; n=15) or EW + RT (EWR; n=15) groups. The WER group ingested three WE while the EWR group ingested an isonitrogenous quantity of six EW per day immediately after the RT session. Serum concentrations of regulatory markers and body composition were measured at baseline and after 12 weeks. Significant main effects of time were observed for bodyweight [WER = 1.7 kg and EWR= 1.8 kg], skeletal muscle mass [WER = 2.9 kg and EWR= 2.7 kg], Fibroblast growth factor 2 [WER = 116.1 pg.ml and EWR= 83.2 pg.ml], and follistatin [WER = 0.05 ng.ml and EWR= 0.04 ng.ml], which significantly increased (p ˂ 0.05); and for fat mass [WER = -1.9 kg and EWR= -1.1 kg], Transforming growth factor-β1 [WER = -0.5 ng.ml and EWR= -0.1 ng.ml], Activin A [WER = -6.2 pg.ml and EWR= -4.5 pg.ml], and myostatin [WER = -0.1 ng.ml and EWR= -0.06 ng.ml], which significantly decreased (p ˂ 0.05) in both the WER and EWR groups. Consumption of eggs absent of yolk during chronic RT results in similar body composition and functional outcomes as WE of equal protein value. EW or WE may be used interchangeably for the dietary support of RT-induced muscular hypertrophy when protein intake is maintained.",2020,"ng.ml], which significantly decreased (p ˂ 0.05) in both the WER and EWR groups.","['resistance-trained men', 'Thirty resistance-trained men (24.6 ± 2.7 years']","['whole egg (WE) vs. egg white (EW) ingestion', 'whole egg vs. egg white ingestion', 'resistance training (RT', 'resistance training', 'EW + RT (EWR']","['Serum concentrations of regulatory markers and body composition', 'myostatin [WER', 'Fibroblast growth factor', 'skeletal muscle regulatory markers', 'skeletal muscle mass', 'Transforming growth factor-β1']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0016026', 'cui_str': 'Fibroblast growth factor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}]",,0.133598,"ng.ml], which significantly decreased (p ˂ 0.05) in both the WER and EWR groups.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi university of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Jo', 'Affiliation': 'Kinesiology & Health Promotion Department, California State Polytechnic University Pomona, Pomona, CA, USA.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Stratton', 'Affiliation': 'Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Damoon Ashtary', 'Initials': 'DA', 'LastName': 'Larky', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002238'] 2401,32576320,"Dietary nitrate improves skeletal muscle microvascular oxygenation in HIV-infected patients receiving highly active antiretroviral therapy: a randomized, double-blind, cross-over, placebo-controlled study.","Human immunodeficiency virus-1 (HIV-1) proteins and highly active antiretroviral therapy (HAART) have been associated with microvascular endothelial dysfunction. Although nitrate-rich beetroot juice (NR-BJ) consumption has been shown to improve endothelial function in clinical population, its effects in the HIV-infected patients has not been addressed. We investigated the effect of a single dose of NR-BJ on muscle oxygen saturation parameters in response to a handgrip exercise in HIV-infected patients. Fifteen HIV-infected patients received NR-BJ or nitrate-depleted beetroot juice (ND-BJ) in a double-blind cross-over design. Near-infrared spectroscopy was utilized to assess muscle oxygen saturation parameters during rhythmic handgrip exercise after NR-BJ or ND-BJ supplementation. A significant faster muscle oxygen desaturation rate during exercise (-7.97±5.00 vs -5.45±3.94 %.s-1; p=0.005) and the muscle oxygen resaturation rate during exercise recovery (0.43±0.24 vs 0.28±0.24 %.s-1; p=0.030) after NR-BJ ingestion was found. However, no significant difference in exercise time until fatigue was observed. Salivary nitrite and urinary nitrate concentration were analysed after NR-BJ or ND-BJ. A significant increase in salivary nitrite and urinary nitrate in NR-BJ condition compared to ND-BJ was observed (p<0.05). Our findings suggest that NR-BJ consumption may acutely improve muscle oxygen saturation during exercise and exercise recovery in HIV-infected patients undergoing HAART, individuals who are expected to present microvascular damage. Thus, future studies investigating the chronic effect of NR-BJ are warranted to delineate a better nutritional strategy based on nitrate-rich foods.",2020,A significant faster muscle oxygen desaturation rate during exercise (-7.97±5.00 vs -5.45±3.94 %.s-1; p=0.005) and the muscle oxygen resaturation rate during exercise recovery (0.43±0.24 vs 0.28±0.24 %.s-1; p=0.030) after NR-BJ ingestion was found.,"['HIV-infected patients receiving highly active antiretroviral therapy', 'Fifteen HIV-infected patients received', 'HIV-infected patients']","['NR-BJ', 'nitrate-rich beetroot juice (NR-BJ) consumption', 'Dietary nitrate', 'Human immunodeficiency virus-1 (HIV-1) proteins and highly active antiretroviral therapy (HAART', 'NR-BJ or nitrate-depleted beetroot juice', 'placebo']","['endothelial function', 'muscle oxygen saturation', 'muscle oxygen desaturation rate', 'muscle oxygen resaturation rate during exercise recovery', 'salivary nitrite and urinary nitrate in NR-BJ condition', 'Salivary nitrite and urinary nitrate concentration', 'skeletal muscle microvascular oxygenation', 'exercise time until fatigue']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0887947', 'cui_str': 'Highly active anti-retroviral therapy'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0887947', 'cui_str': 'Highly active anti-retroviral therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",15.0,0.164489,A significant faster muscle oxygen desaturation rate during exercise (-7.97±5.00 vs -5.45±3.94 %.s-1; p=0.005) and the muscle oxygen resaturation rate during exercise recovery (0.43±0.24 vs 0.28±0.24 %.s-1; p=0.030) after NR-BJ ingestion was found.,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Barros-Santos', 'Affiliation': 'Nutrition and Exercise Metabolism Research Group, Nutrition Institute, Federal University of Rio de Janeiro, Macaé, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gustavo Vieira', 'Initials': 'GV', 'LastName': 'de Oliveira', 'Affiliation': 'Nutrition and Exercise Metabolism Research Group, Nutrition Institute, Federal University of Rio de Janeiro, Macaé, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mônica', 'Initials': 'M', 'LastName': 'Volino-Souza', 'Affiliation': 'Nutrition and Exercise Metabolism Research Group, Nutrition Institute, Federal University of Rio de Janeiro, Macaé, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thiago Silveira', 'Initials': 'TS', 'LastName': 'Alvares', 'Affiliation': 'Nutrition and Exercise Metabolism Research Group, Nutrition Institute, Federal University of Rio de Janeiro, Macaé, Rio de Janeiro, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114520002226'] 2402,32575383,Effect of Mental Fatigue on Postural Sway in Healthy Older Adults and Stroke Populations.,"The aim of this study was to examine the effect of mental fatigue on postural sway under different sensory conditions in healthy older adults and in persons with chronic stroke (PwCS). Thirty healthy older adults (> 60 years old), randomly separated into experimental and control groups, as well as 15 PwCS participated in this study. Experimental groups were asked to stand on a force platform wearing seven inertial sensors while performing the Sensory Organization Test (SOT) under two cognitive conditions (single- and dual-task) before and after a mental fatigue task (stop-signal task for 60 min). The control group performed the same protocol before and after watching a movie for 60 min. Changes in subjective fatigue was assessed by the NASA Task Load Index and psychophysiological workload was assessed by heart rate variability (HRV). Postural sway was assessed by calculating the Jerk and root mean square (RMS) of center of mass (COM). Higher Jerk and RMS of COM ( p < 0.05) were observed after the mental fatigue task in both healthy older adults and PwCS during SOT, which was not observed in the control group ( p > 0.05). Additionally, postural sway increased in the three groups as the SOT conditions became more challenging. Our results indicate that mental fatigue, induced by sustained cognitive activity, can impair balance during SOT in older adult and stroke populations.",2020,"Higher Jerk and RMS of COM ( p < 0.05) were observed after the mental fatigue task in both healthy older adults and PwCS during SOT, which was not observed in the control group ( p > 0.05).","['Thirty healthy older adults (> 60 years old', 'healthy older adults and in persons with chronic stroke (PwCS', 'Healthy Older Adults and Stroke Populations']","['force platform wearing seven inertial sensors while performing the Sensory Organization Test (SOT) under two cognitive conditions (single- and dual-task', 'mental fatigue on postural sway under different sensory conditions', 'Mental Fatigue']","['Higher Jerk and RMS of COM', 'Postural sway', 'Postural Sway', 'subjective fatigue', 'NASA Task Load Index and psychophysiological workload', 'Jerk and root mean square (RMS) of center of mass (COM', 'heart rate variability (HRV', 'postural sway']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0009490', 'cui_str': 'Comoros islands'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}]",30.0,0.0208196,"Higher Jerk and RMS of COM ( p < 0.05) were observed after the mental fatigue task in both healthy older adults and PwCS during SOT, which was not observed in the control group ( p > 0.05).","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Varas-Diaz', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Kannan', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Bhatt', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Brain sciences,['10.3390/brainsci10060388'] 2403,32575387,Snacking on Whole Almonds for Six Weeks Increases Heart Rate Variability during Mental Stress in Healthy Adults: A Randomized Controlled Trial.,"Cardiac autonomic regulation can be indirectly measured by heart rate variability (HRV). Low HRV, which can be induced by mental stress, is a predictor of risk of sudden cardiac death. Few studies have investigated cause-and-effect relationships between diet and HRV. Nut consumption is associated with CVD risk reduction, but the impact on HRV, particularly in response to stress, is unclear. Men and women (30-70 y) with above average risk of developing CVD were randomly assigned in a 6-week randomized, controlled, parallel arm trial to consume either whole almond or isocaloric control snacks (20% of daily estimated energy requirement). Control snacks contained the average nutrient profile of UK snacks. Five-minute periods of supine heart rate (HR) and HRV were measured at resting and during mental stress (Stroop color-word test) at baseline and six weeks. High frequency (HF) power, which reflects parasympathetic regulation of HR, was increased following almonds during the mental stress task relative to control (mean difference between groups 124 ms2; 95% CI 11, 237; p = 0.031, n = 105), but other indices were unaffected. Snacking on whole almonds instead of typical snacks may reduce risk of CVD partly by ameliorating the suppression of HRV during periods of mental stress.",2020,"High frequency (HF) power, which reflects parasympathetic regulation of HR, was increased following almonds during the mental stress task relative to control (mean difference between groups 124 ms2; 95% CI 11, 237; ","['Healthy Adults', 'Men and women (30-70 y) with above average risk of developing CVD']",['consume either whole almond or isocaloric control snacks'],"['heart rate variability (HRV', 'average nutrient profile of UK snacks', 'High frequency (HF) power', 'supine heart rate (HR) and HRV']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]",,0.18945,"High frequency (HF) power, which reflects parasympathetic regulation of HR, was increased following almonds during the mental stress task relative to control (mean difference between groups 124 ms2; 95% CI 11, 237; ","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Dikariyanto', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Chowienczyk', 'Affiliation': ""Department of Clinical Pharmacology, School of Cardiovascular Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London SE1 7EH, UK.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Berry', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}]",Nutrients,['10.3390/nu12061828'] 2404,32575439,Immunoadsorption for Treatment of Patients with Suspected Alzheimer Dementia and Agonistic Autoantibodies against Alpha1a-Adrenoceptor-Rationale and Design of the IMAD Pilot Study.,"BACKGROUND agonistic autoantibodies (agAABs) against G protein-coupled receptors (GPCR) have been linked to cardiovascular disease. In dementia patients, GPCR-agAABs against the α1- and ß2-adrenoceptors (α1AR- and ß2AR) were found at a prevalence of 50%. Elimination of agAABs by immunoadsorption (IA) was successfully applied in cardiovascular disease. The IMAD trial (Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor) investigates whether the removal of α1AR-AABs by a 5-day IA procedure has a positive effect (improvement or non-deterioration) on changes of hemodynamic, cognitive, vascular and metabolic parameters in patients with suspected Alzheimer's clinical syndrome within a one-year follow-up period. METHODS the IMAD trial is designed as an exploratory monocentric interventional trial corresponding to a proof-of-concept phase-IIa study. If cognition capacity of eligible patients scores 19-26 in the Mini Mental State Examination (MMSE), patients are tested for the presence of agAABs by an enzyme-linked immunosorbent assay (ELISA)-based method, followed by a bioassay-based confirmation test, further screening and treatment with IA and intravenous immunoglobulin G (IgG) replacement. We aim to include 15 patients with IA/IgG and to complete follow-up data from at least 12 patients. The primary outcome parameter of the study is uncorrected mean cerebral perfusion measured in mL/min/100 gr of brain tissue determined by magnetic resonance imaging with arterial spin labeling after 12 months. CONCLUSION IMAD is an important pilot study that will analyze whether the removal of α1AR-agAABs by immunoadsorption in α1AR-agAAB-positive patients with suspected Alzheimer's clinical syndrome may slow the progression of dementia and/or may improve vascular functional parameters.",2020,"The IMAD trial (Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor) investigates whether the removal of α1AR-AABs by a 5-day IA procedure has a positive effect (improvement or non-deterioration) on changes of hemodynamic, cognitive, vascular and metabolic parameters in patients with suspected Alzheimer's clinical syndrome within a one-year follow-up period. ","['eligible patients scores 19-26 in the Mini Mental State Examination (MMSE), patients are tested for the presence of agAABs by an enzyme-linked immunosorbent assay (ELISA)-based method, followed by a bioassay-based confirmation test, further screening and treatment with', 'persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor', '15 patients with IA/IgG and to complete follow-up data from at least 12 patients', 'Patients with Suspected Alzheimer Dementia and Agonistic Autoantibodies against Alpha1a-Adrenoceptor-Rationale and Design of the IMAD Pilot Study', ""patients with suspected Alzheimer's clinical syndrome within a one-year follow-up period""]","['IA and intravenous immunoglobulin G (IgG) replacement', 'immunoadsorption', 'IMAD']","['uncorrected mean cerebral perfusion measured in mL/min/100 gr of brain tissue determined by magnetic resonance imaging with arterial spin labeling', 'GPCR-agAABs against the α1- and ß2-adrenoceptors (α1AR- and ß2AR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0537408', 'cui_str': 'ORF74 protein, Human herpesvirus 8'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",15.0,0.184026,"The IMAD trial (Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor) investigates whether the removal of α1AR-AABs by a 5-day IA procedure has a positive effect (improvement or non-deterioration) on changes of hemodynamic, cognitive, vascular and metabolic parameters in patients with suspected Alzheimer's clinical syndrome within a one-year follow-up period. ","[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Stracke', 'Affiliation': 'Department for Internal Medicine A, Nephrology, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, 17475 Greifswald, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lange', 'Affiliation': 'Institute of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bornmann', 'Affiliation': 'Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Kock', 'Affiliation': 'Strategic Research Management, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Klinger-König', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Böhm', 'Affiliation': 'Coordinating Centre for Clinical Trials, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Vogelgesang', 'Affiliation': 'Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'von Podewils', 'Affiliation': 'Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Föel', 'Affiliation': 'Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gross', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, 17475 Greifswald, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wenzel', 'Affiliation': 'Berlin Cures GmbH, 13125 Berlin, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Wallukat', 'Affiliation': 'Berlin Cures GmbH, 13125 Berlin, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Prüss', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE) Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Dressel', 'Affiliation': 'Department of Neurology, Carl-Thiem-Klinikum, 03048 Cottbus, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kunze', 'Affiliation': 'Science Office, Hessenhagen 2, 17268 Flieth-Stegelitz, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Grabe', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Sönke', 'Initials': 'S', 'LastName': 'Langner', 'Affiliation': 'Institute of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, 17475 Greifswald, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Dörr', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, 17475 Greifswald, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9061919'] 2405,32575441,Modulation of Endothelial Glycocalyx and Microcirculation in Healthy Young Men during High-Intensity Sprint Interval Cycling-Exercise by Supplementation with Pomegranate Extract. A Randomized Controlled Trial.,"The natural components of the pomegranate fruit may provide additional benefits for endothelial function and microcirculation. It was hypothesized that supplementation with pomegranate extract might improve glycocalyx properties and microcirculation during acute high-intensity sprint interval cycling exercise. Eighteen healthy and recreationally active male volunteers 22-28 years of age were recruited randomly to the experimental and control groups. The experimental group was supplemented with pomegranate extract 20 mL (720 mg phenolic compounds) for two weeks. At the beginning and end of the study, the participants completed a high-intensity sprint interval cycling-exercise protocol. The microcirculation flow and density parameters, glycocalyx markers, systemic hemodynamics, lactate, and glucose concentration were evaluated before and after the initial and repeated (after 2 weeks supplementation) exercise bouts. There were no significant differences in the microcirculation or glycocalyx over the course of the study ( p < 0.05). The lactate concentration was significantly higher in both groups after the initial and repeated exercise bouts, and were significantly higher in the experimental group compared to the control group after the repeated bout: 13.2 (11.9-14.8) vs. 10.3 (9.3-12.7) mmol/L, p = 0.017. Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise. Although an unexplained rise in blood lactate concentration was observed.",2020,Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise.,"['Healthy Young Men during High', 'Eighteen healthy and recreationally active male volunteers 22-28 years of age']","['pomegranate extract 20 mL', 'Intensity Sprint Interval Cycling-Exercise by Supplementation with Pomegranate Extract', 'high-intensity sprint interval cycling-exercise protocol', 'supplementation with pomegranate extract']","['microcirculation or glycocalyx', 'lactate concentration', 'glycocalyx properties and microcirculation', 'blood lactate concentration', 'microcirculation flow and density parameters, glycocalyx markers, systemic hemodynamics, lactate, and glucose concentration', 'microcirculation and glycocalyx']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1961993', 'cui_str': 'Pomegranate Extract'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",18.0,0.0780625,Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise.,"[{'ForeName': 'Zivile', 'Initials': 'Z', 'LastName': 'Pranskuniene', 'Affiliation': 'Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu pr.13, LT-50162 Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Belousoviene', 'Affiliation': 'Department of Intensive Care Medicine, Lithuanian University of Health Sciences, Eiveniu g. 2, LT-50161 Kaunas, Lithuania.'}, {'ForeName': 'Neringa', 'Initials': 'N', 'LastName': 'Baranauskiene', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Nerijus', 'Initials': 'N', 'LastName': 'Eimantas', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Vaitkaitiene', 'Affiliation': 'Department of Disaster Medicine and Health Research Institute, Lithuanian University of Health Sciences, Eiveniu g. 4, LT-50161 Kaunas, Lithuania.'}, {'ForeName': 'Jurga', 'Initials': 'J', 'LastName': 'Bernatoniene', 'Affiliation': 'Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu pr.13, LT-50162 Kaunas, Lithuania.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Brazaitis', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Pranskunas', 'Affiliation': 'Department of Intensive Care Medicine, Lithuanian University of Health Sciences, Eiveniu g. 2, LT-50161 Kaunas, Lithuania.'}]",International journal of environmental research and public health,['10.3390/ijerph17124405'] 2406,32575705,"Effects of Oral Antihistamines on Tear Volume, Tear Stability, and Intraocular Pressure.","The goal of this study was to investigate the effects of two commonly used oral antihistamines-diphenhydramine and loratadine-on tear volume, tear breakup time, and intraocular pressure. Placebo, diphenhydramine, and loratadine were administered for one week to 33 subjects experimentally blind to the treatment given. All the subjects received all three treatments over a period of six weeks. The outcome measures were the change in phenol red thread test (PRT), the tear breakup time (TBUT), and the intraocular pressure (IOP) of both eyes evaluated by experimentally masked observers. Neither of the mean changes in TBUT or IOP depended on the treatment given, but there was a significant monocular decrease in tear volume from diphenhydramine use. While we used an adequate treatment washout period of seven days, our investigation was limited by the short treatment times and inclusion of only young healthy patients. Overall, however, these results suggest that systemic diphenhydramine use should be limited to increase the effectiveness of conventional therapies. Clinicians should have fewer reservations about recommending the use of loratadine concurrent with dry eye treatments.",2020,"Neither of the mean changes in TBUT or IOP depended on the treatment given, but there was a significant monocular decrease in tear volume from diphenhydramine use.",['young healthy patients'],"['Oral Antihistamines', 'loratadine', 'Placebo, diphenhydramine, and loratadine', 'antihistamines-diphenhydramine and loratadine', 'diphenhydramine']","['tear volume, tear breakup time, and intraocular pressure', 'change in phenol red thread test (PRT), the tear breakup time (TBUT), and the intraocular pressure (IOP) of both eyes evaluated by experimentally masked observers', 'Tear Volume, Tear Stability, and Intraocular Pressure', 'mean changes in TBUT or IOP']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0065180', 'cui_str': 'Loratadine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031430', 'cui_str': 'Phenolsulfonphthalein'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",33.0,0.0262061,"Neither of the mean changes in TBUT or IOP depended on the treatment given, but there was a significant monocular decrease in tear volume from diphenhydramine use.","[{'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Foutch', 'Affiliation': 'Rosenberg School of Optometry, University of the Incarnate Word, San Antonio, TX 78229, USA.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Sandberg', 'Affiliation': 'Rosenberg School of Optometry, University of the Incarnate Word, San Antonio, TX 78229, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Bennett', 'Affiliation': 'College of Optometry, University of Missouri-St Louis, St. Louis, MO 63121, USA.'}, {'ForeName': 'Leonard L', 'Initials': 'LL', 'LastName': 'Naeger', 'Affiliation': 'College of Optometry, University of Missouri-St Louis, St. Louis, MO 63121, USA.'}]","Vision (Basel, Switzerland)",['10.3390/vision4020032'] 2407,32575829,Benefits of High-Flow Nasal Cannula Therapy for Acute Pulmonary Edema in Patients with Heart Failure in the Emergency Department: A Prospective Multi-Center Randomized Controlled Trial.,"Heart failure patients with pulmonary edema presenting to the emergency department (ED) require an effective approach to deliver sufficient oxygen and reduce the rate of intubation and mechanical ventilation in the ED; conventional oxygen therapy has proven ineffective in delivering enough oxygen to the tissues. We aimed to identify whether high-flow nasal cannula (HFNC) therapy over time improved the respiratory rate (RR), lactate clearance, and certain arterial blood gas (ABG) parameters, in comparison with conventional oxygen therapy, in patients with cardiogenic pulmonary edema. This prospective, multi-institutional, and interventional study (clinical trial, reference KCT0004578) conducted between 2016 and 2019 included adult patients diagnosed with heart failure within the previous year and pulmonary edema confirmed at admission. Patients were randomly assigned to the conventional or HFNC group and treated with the goal of maintaining oxygen saturation (SpO 2 ) ≥ 93. We obtained RR, SpO 2 , lactate levels, and ABG parameters at baseline and 30 and 60 min after randomization. All parameters showed greater improvement with HFNC therapy than with conventional therapy. Significant changes in ABG parameters were achieved within 30 min. HFNC therapy could therefore be considered as initial oxygen therapy. Physicians may consider advanced ventilation if there is no significant improvement in ABG parameters within 30 min of HFNC therapy.",2020,All parameters showed greater improvement with HFNC therapy than with conventional therapy.,"['2016 and 2019 included adult patients diagnosed with heart failure within the previous year and pulmonary edema confirmed at admission', 'Patients with Heart Failure in the Emergency Department', 'patients with cardiogenic pulmonary edema', 'Heart failure patients with pulmonary edema presenting to the emergency department (ED']","['conventional oxygen therapy', 'high-flow nasal cannula (HFNC) therapy', 'High-Flow Nasal Cannula Therapy', 'HFNC therapy', 'conventional or HFNC']","['ABG parameters', 'RR, SpO 2 , lactate levels, and ABG parameters', 'respiratory rate (RR), lactate clearance, and certain arterial blood gas (ABG) parameters']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0398350', 'cui_str': 'Acute cardiac pulmonary edema'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205423', 'cui_str': 'Certain'}]",,0.038284,All parameters showed greater improvement with HFNC therapy than with conventional therapy.,"[{'ForeName': 'Dong Ryul', 'Initials': 'DR', 'LastName': 'Ko', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Beom', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Research Affairs, Biostatistics Collaboration Unit, College of Medicine, Yonsei University, Seoul 06273, Korea.'}, {'ForeName': 'Je Sung', 'Initials': 'JS', 'LastName': 'You', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Hyun Soo', 'Initials': 'HS', 'LastName': 'Chung', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Sung Phil', 'Initials': 'SP', 'LastName': 'Chung', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul 06273, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9061937'] 2408,32575919,Gamification in Physical Education: Evaluation of Impact on Motivation and Academic Performance within Higher Education.,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages. Therefore, this research aimed to analyse its impact on the motivations and academic performances of university students. The research was carried out in the training of future teachers specialising in physical education during two academic courses. In total, 127 students participated in the study, divided into a gamified experimental group ( n = 62) and a control group ( n = 65). The participants completed a questionnaire to assess motivation in physical education before and after the intervention and performed a final exam to assess academic performance. The results indicated an increase in external regulation in the experimental group only. Furthermore, this group achieved significantly better academic performance. The findings of this study suggest that gamified implementation is beneficial for academic performance at the university stage, even though intrinsic motivation does not change. Furthermore, the nature of rewards or punishments, as characteristic of this pedagogical approach, could play an important role in the expected results, since external regulation increased significantly after the intervention.",2020,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages.","['127 students participated in the study, divided into a gamified experimental group ( n = 62) and a control group ( n = 65', 'university students']",[],"['academic performance', 'Motivation and Academic Performance', 'external regulation']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",127.0,0.0193045,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ferriz-Valero', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Østerlie', 'Affiliation': 'Research Group DiTePES: Digital Technology in Physical Education and Sports, NTNU-Norwegian University of Science and Technology, NO-7491 Trondheim, Norway.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'García Martínez', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'García-Jaén', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124465'] 2409,32575930,[Application of Endo-GIA stapler in laparoscopic radicalcystectomy].,"Objective: To explore the application of Endo-GIA stapler in laparoscopic radical cystectomy, especially in the treatment of lateral bladder ligament, and to evaluate its clinical feasibility and practicability. Methods: A retrospective analysis of clinical data about 38 cases of laparoscopic radical cystectomy (LRC) treated in the Department of Urology, Chaoyang Hospital of Beijing and Cancer Hospital, Chinese Academy of Medical Sciences from July 2017 to June 2019 were conducted. The patients were divided into Endo-GIA stopler group(18 cases) and non-Endo-GIA stopler group (20 cases) according to whether Endo-GIA stapler were used. The basic clinical data, operation time of bladder lateral ligament, operation time of bladder lateral wall, operation time of bladder resection, amount of bleeding during operation, pathological data after operation and related indicators of recovery after operation were compared between the two groups. Results: All 38 patients underwent radical cystectomy (RC) successfully under 3-D laparoscopy without conversion to open surgery. The operation time of bladder lateral ligament in Endo-GIA stapler group was significantly shorter than that in non-Endo-GIA stapler group [(3.25±0.75) min vs (9.20±2.95) min, P= 0.042]; the operation time of bladder lateral wall in Endo-GIA stapler group was significantly shorter than that in non-Endo-GIA stapler group [(8.06±1.66) min vs (14.30±3.37) min, P= 0.016]. The operation time of cystectomy in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(47.06±4.70) min vs (61.60±14.91) min, P= 0.003]. The amount of bleeding in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(37.77±21.30) ml vs (114.50±39.80) ml, P= 0.015]. The time of drainage tube removal in Endo-GIA group was significantly shorter than that in the non-Endo-GIA group [(5.83±1.54) d vs (7.30±3.00) d, P= 0.002]. The length of post-hospitalization in Endo-GIA group was significantly shorter than that in the non-Endo-GIA group [(7.67±1.78) d vs (9.60±3.25) d, P= 0.036]. However, there was no significant difference in other basic clinical data, post-operative pathology and post-operative recovery related indicators. Conclusions: Laparoscopic radical cystectomy using Endo-GIA stapler device is safe and feasible. It is easy to operate, shorten the operation time significantly, and reduce the amount of bleeding. To a certain extent, it is conducive to the recovery of patients after operation to some extent, and worthy of clinical application.",2020,"The amount of bleeding in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(37.77±21.30) ml vs (114.50±39.80) ml, P= 0.015].","['38 patients underwent', '38 cases of laparoscopic radical cystectomy (LRC) treated in the Department of Urology, Chaoyang Hospital of Beijing and Cancer Hospital, Chinese Academy of Medical Sciences from July 2017 to June 2019 were conducted']","['Endo-GIA stapler', 'Laparoscopic radical cystectomy using Endo-GIA stapler device', 'radical cystectomy (RC) successfully under 3-D laparoscopy without conversion to open surgery', 'non-Endo-GIA stopler group (20 cases) according to whether Endo-GIA stapler']","['operation time of cystectomy', 'operation time of bladder lateral ligament, operation time of bladder lateral wall, operation time of bladder resection, amount of bleeding during operation, pathological data after operation and related indicators of recovery', 'amount of bleeding', 'length of post-hospitalization', 'operation time of bladder lateral ligament', 'operation time of bladder lateral', 'time of drainage tube removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3494226', 'cui_str': 'Conversion to an Open Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0006205', 'cui_str': 'Broad ligament structure'}, {'cui': 'C0496828', 'cui_str': 'Malignant neoplasm of lateral wall of urinary bladder'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}]",,0.0197267,"The amount of bleeding in the Endo-GIA stapler group was significantly shorter than that in the non-Endo-GIA stapler group [(37.77±21.30) ml vs (114.50±39.80) ml, P= 0.015].","[{'ForeName': 'Q X', 'Initials': 'QX', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'F Y', 'Initials': 'FY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Beijing Chao-yang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'X S', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Urology Institute of Shenzhen University, the Third Affiliated Hospital of Shenzhen University, Shenzhen Following Precision Medical Research Institute, Luohu Hospital Group, Shenzhen 518000, China.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Shi', 'Affiliation': 'Department of Urology, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'N Z', 'Initials': 'NZ', 'LastName': 'Xing', 'Affiliation': 'Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20190925-02112'] 2410,32576496,Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study.,"BACKGROUND Trans-arterial chemoembolization (TACE) is one first-line option therapy for patients with hepatocellular carcinoma (HCC) not suitable for surgical resection. AIMS We evaluated the effects of sunitinib plus doxorubicin-TACE on bleeding or liver failure. METHODS Seventy-eight patients with HCC were included in this randomized, double-blind study. They received one to three TACE plus either sunitinib or placebo four weeks out of six for one year. The occurrence of severe bleeding or liver failure was assessed during the week after the TACE. The safety and survival outcomes were evaluated. RESULTS No bleeding complication was reported. One and two liver failures were respectively observed in sunitinib and placebo patients. Compliance to sunitinib treatment was acceptable. Sunitinib dose reduction occurred in 37% of patients due to acute toxicity. Main grade 3-4 toxicities were: thrombocytopenia, neutropenia, increased bilirubin, increased ALT and asthenia. In the sunitinib group, the median PFS and OS were 9.05 [5.81;11.63] and 25.0 [13.5;36.8] months, respectively. In the placebo group, the median PFS and OS were 5.51 [4.14;7.79] and 20.5 [15.1;30.6] months, respectively. CONCLUSIONS TACE plus sunitinib in the first-line therapy for patients with HCC not suitable for surgical resection was feasible. CLINICALTRIALS. GOV NUMBER NCT01164202.",2020,No bleeding complication was reported.,"['unresectable hepatocellular carcinoma', 'Seventy-eight patients with HCC', 'patients with hepatocellular carcinoma (HCC) not suitable for surgical resection']","['TACE plus sunitinib', 'Liver transarterial chemoembolization and sunitinib', 'TACE plus either sunitinib or placebo', 'sunitinib plus doxorubicin-TACE', 'Trans-arterial chemoembolization (TACE', 'placebo']","['acute toxicity', 'thrombocytopenia, neutropenia, increased bilirubin, increased ALT and asthenia', 'bleeding or liver failure', 'median PFS and OS', 'safety and survival outcomes', 'severe bleeding or liver failure', 'bleeding complication']","[{'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",78.0,0.0655466,No bleeding complication was reported.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turpin', 'Affiliation': 'Department of Medical Oncology, University Hospital, Lille, France. Electronic address: anthony.turpin@chru-lille.fr.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'de Baere', 'Affiliation': 'Department of Surgical Radiology, Gustave Roussy Institute, Villejuif, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Heurgué', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Robert Debré, Reims, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Statistics Department, Fédération Francophone de cancérologie Digestive, Dijon, France; EPICAD inserm LNC-UMR 1231, University of Burgundy and Franche-Comté, Dijon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ollivier-Hourmand', 'Affiliation': 'Department of Hepato-Gastroenterology and Nutrition, University Hospital Côte de Nacre, Caen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital, Tours, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Perrier', 'Affiliation': 'Department of Hepato-Gastroenterology and Oncology, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Vergniol', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital, Pessac, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sefrioui', 'Affiliation': 'Inserm 1245, IRON group, Hepato-Gastroenterology unit, University Hospital, Rouen, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': 'Oncology Unit, European Hospital, Marseille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Edeline', 'Affiliation': 'Department of Medical Oncology, Eugène Marquis center, Rennes, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Jouve', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital François Mitterrand, Dijon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Silvain', 'Affiliation': 'Hepato-Gastroenterology Unit, University Hospital, Poitiers, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Becouarn', 'Affiliation': 'Digestive Tumours Unit, Bergonié Institute, Bordeaux, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Dauvois', 'Affiliation': 'Department of Hepato-gastroenterology, La Source Hospital, Orléans, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Baconnier', 'Affiliation': 'Gastroenterology Department, CH Annecy Genevois, Pringy, France.'}, {'ForeName': 'Maryline', 'Initials': 'M', 'LastName': 'Debette-Gratien', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Dupuytren, Limoges, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': 'Medical Oncology, Saint Joseph Hospital, Paris, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Dharancy', 'Affiliation': 'Department of Hepato-Gastroenterology, inserm U995, University Hospital, Lille, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital François Mitterrand, Dijon, France; EPICAD inserm LNC-UMR 1231, University of Burgundy and Franche-Comté, Dijon, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hebbar', 'Affiliation': 'Department of Medical Oncology, University Hospital, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.05.012'] 2411,32576548,Covid-19: Demand for dexamethasone surges as RECOVERY trial publishes preprint.,,2020,,[],['dexamethasone'],[],[],"[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]",[],,0.0571111,,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Mahase', 'Affiliation': 'The BMJ.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m2512'] 2412,32576561,Effect of treatment with exenatide and pioglitazone or basal-bolus insulin on diabetic neuropathy: a substudy of the Qatar Study.,"INTRODUCTION To assess the effect of exenatide and pioglitazone or basal-bolus insulin on diabetic peripheral neuropathy (DPN) in patients with poorly controlled type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS This is a substudy of the Qatar Study, an open-label, randomized controlled trial. 38 subjects with poorly controlled T2D were studied at baseline and 1-year follow-up and 18 control subjects were assessed at baseline only. A combination of exenatide (2 mg/week) and pioglitazone (30 mg/day) or glargine with aspart insulin were randomly assigned to patients to achieve an HbA1c <53 mmol/mol (<7%). DPN was assessed with corneal confocal microscopy (CCM), DN4, vibration perception and sudomotor function. RESULTS Subjects with T2D had reduced corneal nerves, but other DPN measures were comparable with the control group. In the combination treatment arm (n=21), HbA1c decreased by 35.2 mmol/mol (3.8 %) (p<0.0001), body weight increased by 5.6 kg (p<0.0001), corneal nerve branch density increased (p<0.05), vibration perception worsened (p<0.05), and DN4 and sudomotor function showed no change. In the insulin treatment arm, HbA1c decreased by 28.7 mmol/mol (2.7 %) (p<0.0001), body weight increased by 4.6 kg (p<0.01), corneal nerve branch density and fiber length increased (p≤0.01), vibration perception improved (p<0.01), and DN4 and sudomotor function showed no change. There was no association between the change in CCM measures with change in HbA1c, weight or lipids. CONCLUSIONS Treatment with exenatide and pioglitazone or basal-bolus insulin results in corneal nerve regeneration, but no change in neuropathic symptoms or sudomotor function over 1 year.",2020,"In the insulin treatment arm, HbA1c decreased by 28.7 mmol/mol (2.7 %) (p<0.0001), body weight increased by 4.6 kg (p<0.01), corneal nerve branch density and fiber length increased (p≤0.01), vibration perception improved (p<0.01), and DN4 and sudomotor function showed no change.","['patients with poorly controlled type 2 diabetes (T2D', 'diabetic neuropathy', '38 subjects with poorly controlled T2D']","['pioglitazone', 'exenatide and pioglitazone', 'exenatide', 'glargine with aspart insulin']","['HbA1c, weight or lipids', 'HbA1c', 'body weight', 'corneal nerve regeneration', 'DPN measures', 'corneal nerve branch density and fiber length increased (p≤0.01), vibration perception improved (p<0.01), and DN4 and sudomotor function', 'neuropathic symptoms or sudomotor function', 'vibration perception worsened (p<0.05), and DN4 and sudomotor function', 'reduced corneal nerves', 'diabetic peripheral neuropathy (DPN', 'corneal nerve branch density', 'corneal confocal microscopy (CCM), DN4, vibration perception and sudomotor function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0027756', 'cui_str': 'Nerve Regeneration'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}]",38.0,0.0653703,"In the insulin treatment arm, HbA1c decreased by 28.7 mmol/mol (2.7 %) (p<0.0001), body weight increased by 4.6 kg (p<0.01), corneal nerve branch density and fiber length increased (p≤0.01), vibration perception improved (p<0.01), and DN4 and sudomotor function showed no change.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Ponirakis', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, Doha, Qatar.'}, {'ForeName': 'Muhammad A', 'Initials': 'MA', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Diabetes Division, University of Texas Health Science Center, San Antonio, Texas, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Jayyousi', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Ad Dawhah, Qatar.'}, {'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Almuhannadi', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, Doha, Qatar.'}, {'ForeName': 'Ioannis N', 'Initials': 'IN', 'LastName': 'Petropoulos', 'Affiliation': 'Weill Cornell Medical College in Qatar, Doha, Qatar.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, Doha, Qatar.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Gad', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, Doha, Qatar.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Migahid', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Ad Dawhah, Qatar.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Megahed', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Ad Dawhah, Qatar.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Ziyad', 'Initials': 'Z', 'LastName': 'Mahfoud', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, Doha, Qatar.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Ad Dawhah, Qatar.'}, {'ForeName': 'Hanadi', 'Initials': 'H', 'LastName': 'Al Hamad', 'Affiliation': 'Department of Geriatrics and Long Term Care, Qatar Rehabilitation Institute, Doha, Qatar.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Ramadan', 'Affiliation': 'Department of Geriatrics and Long Term Care, Qatar Rehabilitation Institute, Doha, Qatar.'}, {'ForeName': 'Uazman', 'Initials': 'U', 'LastName': 'Alam', 'Affiliation': 'Aintree University Hospitals NHS Foundation Trust, Liverpool, Liverpool, UK.'}, {'ForeName': 'Rayaz A', 'Initials': 'RA', 'LastName': 'Malik', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, Manchester, UK ram2045@qatar-med.cornell.edu.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001420'] 2413,32576828,Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial.,"Short-term fasting protects tumor-bearing mice against the toxic effects of chemotherapy while enhancing therapeutic efficacy. We randomized 131 patients with HER2-negative stage II/III breast cancer, without diabetes and a BMI over 18 kg m -2 , to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy. Here we show that there was no difference in toxicity between both groups, despite the fact that dexamethasone was omitted in the FMD group. A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039). Moreover, per-protocol analysis reveals that the Miller&Payne 4/5 pathological response, indicating 90-100% tumor-cell loss, is more likely to occur in patients using the FMD (OR 4.109, P = 0.016). Also, the FMD significantly curtails chemotherapy-induced DNA damage in T-lymphocytes. These positive findings encourage further exploration of the benefits of fasting/FMD in cancer therapy. Trial number: NCT02126449.",2020,"A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039).","['131 patients with HER2-negative stage II/III breast cancer, without diabetes and a BMI over 18\u2009kg\u2009m -2 , to receive either a']","['Fasting mimicking diet', 'chemotherapy', 'fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy', 'dexamethasone']","['Miller&Payne 4/5 pathological response', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",131.0,0.0375448,"A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039).","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Rieneke T', 'Initials': 'RT', 'LastName': 'Lugtenberg', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Marij J P', 'Initials': 'MJP', 'LastName': 'Welters', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Ilina', 'Initials': 'I', 'LastName': 'Ehsan', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Maaike P G', 'Initials': 'MPG', 'LastName': 'Vreeswijk', 'Affiliation': 'Department of Human Genetics, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Vincent T H B M', 'Initials': 'VTHBM', 'LastName': 'Smit', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hiltje', 'Initials': 'H', 'LastName': 'de Graaf', 'Affiliation': 'Department of Medical Oncology, Medical center Leeuwarden, P.O. Box 888, 8901 NR, Leeuwarden, The Netherlands.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Heijns', 'Affiliation': 'Department of Medical Oncology, Amphia, P.O. Box 90157, 4800 RL, Breda, The Netherlands.'}, {'ForeName': 'Johanneke E A', 'Initials': 'JEA', 'LastName': 'Portielje', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Agnes J', 'Initials': 'AJ', 'LastName': 'van de Wouw', 'Affiliation': 'Department of Medical Oncology, Viecuri, 5912BL, Venlo, The Netherlands.'}, {'ForeName': 'Alex L T', 'Initials': 'ALT', 'LastName': 'Imholz', 'Affiliation': 'Department of Medical Oncology, Deventer hospital, P.O. Box 5001, 7416 SE, Deventer, The Netherlands.'}, {'ForeName': 'Lonneke W', 'Initials': 'LW', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Oncology, Deventer hospital, P.O. Box 5001, 7416 SE, Deventer, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Vrijaldenhoven', 'Affiliation': 'Department of Medical Oncology, Noordwest hospital group, location Alkmaar, P.O. Box 501, 1815 JD, Alkmaar, The Netherlands.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Baars', 'Affiliation': 'Department of Medical Oncology, Hospital Gelderse vallei, 6710 HN, Ede, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Marjolijn Duijm-de', 'Initials': 'MD', 'LastName': 'Carpentier', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, P.O. Box 9600, 2300RC, Leiden, The Netherlands.'}, {'ForeName': 'Jacobus J M', 'Initials': 'JJM', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Johan W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Longo', 'Affiliation': 'Longevity Institute, School of Gerontology, and Department of Biological Sciences, University of Southern California, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Department of Endocrinology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. j.r.kroep@lumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-020-16138-3'] 2414,32576882,Author Correction: Kinesiologist-guided functional exercise in addition to intradialytic cycling program in end-stage kidney disease patients: a randomised controlled trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['end-stage kidney disease patients'],"['intradialytic cycling program', 'Author Correction: Kinesiologist-guided functional exercise']",[],"[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}]",[],,0.0729056,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Pajek', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jadranka Buturović', 'Initials': 'JB', 'LastName': 'Ponikvar', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Vedran', 'Initials': 'V', 'LastName': 'Hadžić', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia. maja.pajek@fsp.uni-lj.si.'}]",Scientific reports,['10.1038/s41598-020-67057-8'] 2415,32577192,The Impact of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training on Carotid Intima-Media Thickness and Ankle-Brachial Index in Middle-Aged Women.,"Objective Obesity has been linked to cardiovascular risk factors characterized by endothelial dysfunction and arterial wall thickening. Regular exercise training is recognized as a powerful tool to improve endothelial function and cardiovascular risk profile, but it is unknown which of high-intensity interval training or moderate-intensity continuous training is the best exercise. Materials and Methods A total of 33 inactive and overweight women aged 40-50 years old and body mass index >27 kg/m 2 were randomized to high-intensity interval training, moderate-intensity continuous training, or control. The exercise intervention consisted of 12 weeks of training and three supervised sessions per week. The moderate-intensity group was trained continuously for 47 min at 60-70% of maximal heart rate. High-intensity interval training consisted of four interval bouts of 4 min at 85%-95% of maximal heart rate with 3 min breaks at 50%-60% of maximal heart rate between the intervals. For all analyses, statistical significance was assigned at P < 0.05. Results According to our findings, while carotid intima-media thickness decreased in both training groups, this reduction was not statistically significant. In the high-intensity training group, the right ankle-brachial index increased significantly ( P = 0.007). Conclusion Twelve weeks of exercise training, especially in high-intensity interval training, have led to improving lipid profiles and endothelial function, it can be said that regular and prolonged exercise can probably be a preventive factor in cardiovascular disease in overweight women.",2020,"In the high-intensity training group, the right ankle-brachial index increased significantly ( P = 0.007). ","['Middle-Aged Women', 'overweight women', '33 inactive and overweight women aged 40-50 years old and body mass index >27 kg/m 2']","['exercise training, especially in high-intensity interval training', 'Regular exercise training', 'High-Intensity Interval Training Versus Moderate-Intensity Continuous Training', 'high-intensity interval training, moderate-intensity continuous training, or control']","['right ankle-brachial index', 'carotid intima-media thickness', 'Carotid Intima-Media Thickness and Ankle-Brachial Index', 'endothelial function and cardiovascular risk profile']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0230447', 'cui_str': 'Structure of right ankle'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.033021,"In the high-intensity training group, the right ankle-brachial index increased significantly ( P = 0.007). ","[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Farahati', 'Affiliation': 'Department of Sports Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Seyyed Reza Attarzadeh', 'Initials': 'SRA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Sports Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Moazzami', 'Affiliation': 'Department of Sports Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Mahdi Hasanzadeh', 'Initials': 'MH', 'LastName': 'Daloee', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shima Hasanzadeh', 'Initials': 'SH', 'LastName': 'Daloee', 'Affiliation': 'Department of Radiology, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_524_18'] 2416,32577193,Enhancing Breastfeeding - Home-Based Education on Self-Efficacy: A Preventive Strategy.,"Background The aim of this study is to evaluate the effects of home-based education intervention on the exclusivity and promoting the rates of self-efficacy of breastfeeding. Materials and Methods A randomized controlled trial was conducted Arak University of Medical Sciences in Takeghani Hospital in Iran between June 2015 and October 2015. A total of 130 eligible and voluntary women hospitalized in Arak University of Medical Sciences Hospital postpartum wards were randomized to receive usual care ( n = 65) or education with CD and pamphlets ( n = 65). Data regarding exclusive breastfeeding were collected using Denis and Fox's breastfeeding self-efficacy questionnaire. The primary outcome was collected by one assistant researcher during first postpartum visit. The secondary outcome was collected 4 weeks after birth of babies by telephone interviews. Data analysis was performed using descriptive (frequency, mean), independent samples t -test, Student's t -test, t 2 -test, and Chi-square test. All values of P < 0.05 were considered statistically significant. Results There was no significant differences between the intervention and control groups with regard to age ( P = 0.086) and gestational age ( P = 0.741). The breastfeeding self-efficacy scores were higher in the intervention group (63.66 ± 6.11) than in the control group (57.04 ± 6.18) after 1 month of childbirth ( P = 0.001). The exclusive breastfeeding rate in intervention group was 89.2 ( n = 58) at 1 st month after education compared with 55.4% ( n = 36) in control group ( P = 0.001). Conclusions In a setting, a high breastfeeding rate and self-efficacy scores were found in education group. Therefore, nurses and midwives are thus required to adopt various health education strategies, such as home education, encourage breastfeeding.",2020,There was no significant differences between the intervention and control groups with regard to age ( P = 0.086) and gestational age ( P = 0.741).,"['Arak University of Medical Sciences in Takeghani Hospital in Iran between June 2015 and October 2015', '130 eligible and voluntary women hospitalized in Arak University of Medical Sciences Hospital postpartum wards']","['home-based education intervention', 'usual care ( n = 65) or education with CD and pamphlets']","['breastfeeding self-efficacy scores', 'exclusive breastfeeding rate', 'breastfeeding rate and self-efficacy scores']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",130.0,0.0555253,There was no significant differences between the intervention and control groups with regard to age ( P = 0.086) and gestational age ( P = 0.741).,"[{'ForeName': 'Katayon', 'Initials': 'K', 'LastName': 'Vakilian', 'Affiliation': 'Medical School, Traditional and Complementary Medicine Center (TCMRC), Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Ome Colsum Tabarte', 'Initials': 'OCT', 'LastName': 'Farahani', 'Affiliation': 'Nursing Midwifery School, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Heidari', 'Affiliation': 'Nursing Midwifery School, Arak University of Medical Sciences, Arak, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_494_17'] 2417,32577299,A randomised feasibility study of computerised cognitive training as a therapeutic intervention for people with Huntington's disease (CogTrainHD).,"Background Huntington's disease (HD) is associated with a range of cognitive deficits including problems with executive function. In the absence of a disease modifying treatment, cognitive training has been proposed as a means of slowing cognitive decline; however, the impact of cognitive training in HD patient populations remains unclear. The CogTrainHD study assessed the feasibility and acceptability of home-based computerised executive function training, for people impacted by HD. Methods Thirty HD gene carriers were recruited and randomised to either executive function training or non-intervention control groups. Participants allocated to the intervention group were asked to complete executive function training three times a week for 30 min for 12 weeks in their own homes. Semi-structured interviews were conducted with participants and friends, family or carers, to determine their views on the study. Results 26 out of 30 participants completed the baseline assessments and were subsequently randomised: 13 to the control group and 13 to the intervention group. 23 of the 30 participants were retained until study completion: 10/13 in the intervention group and 13/13 in the control group. 4/10 participants fully adhered to the executive function training. All participants in the control group 13/13 completed the study as intended. Interview data suggested several key facilitators including participant determination, motivation, incorporation of the intervention into routine and support from friends and family members. Practical limitations, including lack of time, difficulty and frustration in completing the intervention, were identified as barriers to study completion. Conclusions The CogTrainHD feasibility study provides important evidence regarding the feasibility and acceptability of a home-based cognitive training intervention for people with HD. Variable adherence to the cognitive training implies that the intervention is not feasible to all participants in its current form. The study has highlighted important aspects in relation to both the study and intervention design that require consideration, and these include the design of games in the executive function training software, logistical considerations such as lack of time, the limited time participants had to complete the intervention and the number of study visits required. Further studies are necessary before computerised executive function training can be recommended routinely for people with HD. Trial registration ClinicalTrials.gov, Registry number NCT02990676.",2020,Participants allocated to the intervention group were asked to complete executive function training three times a week for 30 min for 12 weeks in their own homes.,"[""people with Huntington's disease (CogTrainHD"", 'people with HD', 'Methods\n\n\nThirty HD gene carriers', '4/10 participants fully adhered to the executive function training', '23 of the 30 participants were retained until study completion', 'people impacted by HD']","['cognitive training', 'complete executive function training', 'executive function training or non-intervention control groups', 'computerised cognitive training', 'home-based cognitive training intervention', 'home-based computerised executive function training']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0589092', 'cui_str': 'Executive functions training'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589092', 'cui_str': 'Executive functions training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],30.0,0.0322077,Participants allocated to the intervention group were asked to complete executive function training three times a week for 30 min for 12 weeks in their own homes.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Yhnell', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University (NMHRI), 3rd Floor, Hadyn Ellis Building, Maindy Road, Cardiff, CF24 4HQ UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Furby', 'Affiliation': 'School of Psychology, Cardiff University Brain Research Imaging Centre (CUBRIC), Maindy Road, Cardiff University, Cardiff, CF24 4HQ UK.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research (CTR), Cardiff University, Neuadd Meironnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research (CTR), Cardiff University, Neuadd Meironnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Cheney J G', 'Initials': 'CJG', 'LastName': 'Drew', 'Affiliation': 'Centre for Trials Research (CTR), Cardiff University, Neuadd Meironnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research (CTR), Cardiff University, Neuadd Meironnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Watson', 'Affiliation': 'Centre for Trials Research (CTR), Cardiff University, Neuadd Meironnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Metzler-Baddeley', 'Affiliation': 'School of Psychology, Cardiff University Brain Research Imaging Centre (CUBRIC), Maindy Road, Cardiff University, Cardiff, CF24 4HQ UK.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Rosser', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University (NMHRI), 3rd Floor, Hadyn Ellis Building, Maindy Road, Cardiff, CF24 4HQ UK.'}, {'ForeName': 'Monica E', 'Initials': 'ME', 'LastName': 'Busse', 'Affiliation': 'Centre for Trials Research (CTR), Cardiff University, Neuadd Meironnydd, Heath Park, Cardiff, CF14 4YS UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00623-z'] 2418,32577303,Enhanced injury prevention programme for recreational runners (the SPRINT study): design of a randomised controlled trial.,"Introduction Running-related injuries (RRIs) are frequent, but no effective injury prevention measures have been identified yet. Therefore, we have set up the INSPIRE trial in 2017, in which the effectiveness of an online injury prevention programme was tested. Although this programme was not effective in reducing the number of RRIs, we gained new insights from this study, which we used to design an enhanced, online multidisciplinary injury prevention programme. The aim of this study is to test the effectiveness of this enhanced injury prevention programme in a group of recreational runners. Methods and analysis For this randomised controlled trial, we aim to include 3394 recreational runners aged 18 years or older who register for a running event (distances 10 to 42.2 km). During the preparation for the running event, runners in the intervention group get access to the enhanced online injury prevention programme. This online programme consists of 10 steps, all covering separate items of RRI prevention. Runners in the control group will follow their regular preparation. With three follow-up questionnaires (1 month before, 1 week before and 1 month after the running event), the proportions of self-reported RRIs in the intervention group and the control group are compared. Ethics and dissemination An exemption for a comprehensive application has been obtained by the Medical Ethical Committee of the Erasmus MC University Medical Center, Rotterdam, the Netherlands. The results of the study will be disseminated among the running population, published in peer-reviewed international journals and presented on international conferences. Trial registration number NL7694.",2020,"During the preparation for the running event, runners in the intervention group get access to the enhanced online injury prevention programme.","['a group of recreational runners', 'recreational runners', '3394 recreational runners aged 18 years or older who register for a running event (distances 10 to 42.2\u2009km']",['enhanced injury prevention programme'],[],"[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0150638', 'cui_str': 'Preventing injury'}]",[],3394.0,0.0937416,"During the preparation for the running event, runners in the intervention group get access to the enhanced online injury prevention programme.","[{'ForeName': 'Tryntsje', 'Initials': 'T', 'LastName': 'Fokkema', 'Affiliation': 'Department of General Practice, Erasmus MC Medical University Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Department of Orthopaedics, Erasmus MC Medical University Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Visser', 'Affiliation': ""Department of Physiotherapy, Sport Medical Center 'Sportgeneeskunde Rotterdam', Rotterdam, The Netherlands.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Krastman', 'Affiliation': 'Department of General Practice, Erasmus MC Medical University Center, Rotterdam, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'IJzerman', 'Affiliation': 'Dutch Athletic Federation, Arnhem, The Netherlands.'}, {'ForeName': 'Bart W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus MC Medical University Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A N', 'Initials': 'JAN', 'LastName': 'Verhaar', 'Affiliation': 'Department of Orthopaedics, Erasmus MC Medical University Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Sita M A', 'Initials': 'SMA', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Department of General Practice, Erasmus MC Medical University Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marienke', 'Initials': 'M', 'LastName': 'van Middelkoop', 'Affiliation': 'Department of General Practice, Erasmus MC Medical University Center, Rotterdam, The Netherlands.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2020-000780'] 2419,32577298,"Feasibility of ""Sit Less, Move More"": An intervention for reducing sedentary behavior Among African Americans with MS.","Background Sedentary behavior is a major concern in multiple sclerosis, as it may accelerate disease progression and physical disability. This is especially concerning in African Americans, who present with greater neurological disability than Caucasians. Objective We conducted a feasibility trial on an intervention targeting sedentary behavior in African Americans with multiple sclerosis. Methods We examined the feasibility of the Sit Less, Move More program, a 12-week behavioral intervention that used text messaging along with theory-driven newsletters and behavioral coaching for managing sedentary behavior. We recruited ambulatory, inactive, African Americans with multiple sclerosis, and assessed feasibility on process, resource, management, and scientific outcomes. Results Of the 64 people initially contacted, 45 were assessed for eligibility, 31 were sent the informed consent document, and 30 returned a signed document and were included in the study. Study costs were US$7242.38. Personnel time to complete the study was 130 h. There was a small effect on both device-measured ( d =  -0.19) and self-reported ( d =  -0.39) sedentary behavior. Conclusions The Sit Less, Move More intervention is safe and feasible for African Americans with multiple sclerosis, and yielded a small reduction in sedentary behavior. The intervention was low cost and well received. Our results suggest the Sit Less, Move More program should progress towards a Phase II trial to determine its efficacy.",2020,"The Sit Less, Move More intervention is safe and feasible for African Americans with multiple sclerosis, and yielded a small reduction in sedentary behavior.","['African Americans with MS', '64 people initially contacted', 'African Americans with multiple sclerosis', 'African Americans, who present with greater neurological disability than Caucasians']","['behavioral intervention that used text messaging along with theory-driven newsletters and behavioral coaching', 'Sit Less, Move More']",[],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]",[],,0.0278393,"The Sit Less, Move More intervention is safe and feasible for African Americans with multiple sclerosis, and yielded a small reduction in sedentary behavior.","[{'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Baird', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Jeffer E', 'Initials': 'JE', 'LastName': 'Sasaki', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Triangulo Mineiro, Brazil.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, USA.'}]","Multiple sclerosis journal - experimental, translational and clinical",['10.1177/2055217320932341'] 2420,32577708,"Effect of audiovisual eyeglasses on intraoperative pain, anxiety, and hemodynamic changes during mandibular third molar extraction: a randomized controlled clinical trial.","OBJECTIVES To determine the effect of audiovisual eyeglasses in terms of anxiety relief, hemodynamic changes, and intraoperative pain in patients undergoing surgical removal of a mandibular third molar. METHOD AND MATERIALS A randomized controlled clinical trial with two parallel groups was carried out in patients undergoing mandibular third molar extraction. Fifteen patients watched a video with multimedia eyeglasses during the surgical procedure, whereas 15 controls had their eyes covered during extraction. The patients completed anxiety questionnaires before and after surgery. Hemodynamic changes, intraoperative pain, duration of the surgery, and overall satisfaction were recorded. RESULTS Thirty patients were analyzed. Intraoperative pain and the need for supplemental anesthesia were significantly more frequent in the control group (53.3% versus 13.3%; P < .05). The surgical procedure was also briefer when the eyeglasses were used (17.2 versus 28.1 minutes). Overall satisfaction was similar in both groups. No significant differences were found between the two study groups in terms of anxiety and hemodynamic parameters. CONCLUSIONS The use audiovisual eyeglasses should be routinely considered during mandibular third molar extraction since these devices allow reduction of intraoperative pain and surgery time. However, patient anxiety level and hemodynamic parameters seem to remain unaltered.",2020,Intraoperative pain and the need for supplemental anesthesia were significantly more frequent in the control group (53.3% versus 13.3%; P < .05).,"['patients undergoing mandibular third molar extraction', 'patients undergoing surgical removal of a mandibular third molar', 'mandibular third molar extraction', 'Thirty patients were analyzed', 'Fifteen patients watched a video with multimedia eyeglasses during the surgical procedure, whereas 15 controls had their eyes covered during extraction']",['audiovisual eyeglasses'],"['anxiety questionnaires', 'Overall satisfaction', 'anxiety relief, hemodynamic changes, and intraoperative pain', 'intraoperative pain, anxiety, and hemodynamic changes', 'Intraoperative pain and the need for supplemental anesthesia', 'anxiety and hemodynamic parameters', 'Hemodynamic changes, intraoperative pain, duration of the surgery, and overall satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.0923606,Intraoperative pain and the need for supplemental anesthesia were significantly more frequent in the control group (53.3% versus 13.3%; P < .05).,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Luque-Ribas', 'Affiliation': ''}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': ''}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Guerra-Pereira', 'Affiliation': ''}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Valmaseda-Castellón', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44811'] 2421,32577737,Four-Week Ankle-Rehabilitation Programs in Adolescent Athletes With Chronic Ankle Instability.,"CONTEXT Researchers have shown that rehabilitation programs incorporating resistance-band and balance-board exercises are effective for improving clinical measures of function and patient-reported outcomes in individuals with chronic ankle instability (CAI). However, whether combining the 2 exercises increases improvement is unknown. OBJECTIVE To determine the effectiveness of 3 rehabilitation programs on clinical measures of balance and self-reported function in adolescent patients with CAI. DESIGN Randomized controlled clinical trial (registry NCT03447652, clinicaltrials.gov). SETTING High school athletic training facilities. PATIENTS OR OTHER PARTICIPANTS Forty-three patients with CAI (age = 16.37 ± 1.00 years, height = 171.75 ± 12.05 cm, mass = 69.38 ± 18.36 kg) were block randomized into 4 rehabilitation groups. INTERVENTION(S) Protocols were completed 3 times per week for 4 weeks. The resistance-band group performed 3 sets of 10 repetitions of ankle plantar flexion, dorsiflexion, inversion, and eversion with a resistance band. The Biomechanical Ankle Platform System group performed 5 trials of clockwise and counterclockwise rotations, changing direction every 10 seconds during each 40-second trial. The combination group completed resistance-band and Biomechanical Ankle Platform System programs during each session. The control group did not perform any exercises. MAIN OUTCOME MEASURE(S) Variables were assessed before and after the intervention: time-in-balance test, foot-lift test, Star Excursion Balance Test, side-hop test, figure-8 hop test, Foot and Ankle Ability Measure, and Cumberland Ankle Instability Tool. We conducted 4 separate multivariate repeated-measures analyses of variance, followed by univariate analyses for any findings that were different. RESULTS Using the time-in-balance test, foot-lift test, Star Excursion Balance Test (medial, posteromedial, and posterolateral directions), and figure-8 hop test, we detected improvement for each rehabilitation group compared with the control group (P < .05). However, no intervention group was superior. CONCLUSIONS All 3 rehabilitation groups demonstrated improvement compared with the control group, yet the evidence was too limited to support a superior intervention. Over a 4-week period, either of the single-task interventions or the combination intervention can be used to combat the residual deficits associated with CAI in an adolescent patient population.",2020,"All 3 rehabilitation groups demonstrated improvement compared with the control group, yet the evidence was too limited to support a superior intervention.","['Adolescent Athletes', 'individuals with chronic ankle instability (CAI', 'Forty-three patients with CAI (age = 16.37 ± 1.00 years, height = 171.75 ± 12.05 cm, mass = 69.38 ± 18.36 kg', 'High school athletic training facilities', 'adolescent patients with CAI', 'adolescent patient population']",['3 rehabilitation programs'],"['time-in-balance test, foot-lift test, Star Excursion Balance Test, side-hop test, figure-8 hop test, Foot and Ankle Ability Measure, and Cumberland Ankle Instability Tool', 'time-in-balance test, foot-lift test, Star Excursion Balance Test (medial, posteromedial, and posterolateral directions']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",43.0,0.0290524,"All 3 rehabilitation groups demonstrated improvement compared with the control group, yet the evidence was too limited to support a superior intervention.","[{'ForeName': 'M Spencer', 'Initials': 'MS', 'LastName': 'Cain', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Ban', 'Affiliation': 'Department of Kinesiology and Health, Georgia State University, Atlanta.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Therapy, Georgia State University, Atlanta.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Geil', 'Affiliation': 'Department of Exercise Science and Sports Management, Kennesaw State University, Georgia.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Goerger', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Shelley W', 'Initials': 'SW', 'LastName': 'Linens', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene. Dr Linens is now with the Department of Kinesiology, University of North Carolina at Charlotte.'}]",Journal of athletic training,['10.4085/1062-6050-41-19'] 2422,32577745,Effect of Thyroid Hormone Therapy on Fatigability in Older Adults With Subclinical Hypothyroidism: A Nested Study Within a Randomized Placebo-Controlled Trial.,"BACKGROUND Fatigue often triggers screening for and treatment of subclinical hypothyroidism. However, data on the impact of levothyroxine on fatigue is limited and previous studies might not have captured all aspects of fatigue. METHOD This study is nested within the randomized, placebo-controlled, multicenter TRUST trial, including community-dwelling participants aged ≥65 and older, with persistent subclinical hypothyroidism (TSH 4.60-19.99 mIU/L, normal free thyroxine levels) from Switzerland and Ireland. Interventions consisted of daily levothyroxine starting with 50 μg (25 μg if weight <50 kg or known coronary heart diseases) together with dose adjustments to achieve a normal TSH and mock titration in the placebo group. Main outcome was the change in physical and mental fatigability using the Pittsburgh Fatigability Scale over 1 year, assessed through multivariable linear regression with adjustment for country, sex, and levothyroxine starting dose. RESULTS Among 230 participants, the mean ± standard deviation (SD) TSH was 6.2 ± 1.9 mIU/L at baseline and decreased to 3.1 ± 1.3 with LT4 (n = 119) versus 5.3 ± 2.3 with placebo (n = 111, p < .001) after 1 year. After adjustment we found no between-group difference at 1 year on perceived physical (0.2; 95% CI -1.8 to 2.1; p = .88), or mental fatigability (-1.0; 95% CI -2.8 to 0.8; p = .26). In participants with higher fatigability at baseline (≥15 points for the physical score [n = 88] or ≥13 points for the mental score [n = 41]), the adjusted between-group differences at 1 year were 0.4 (95% CI -3.6 to 2.8, p = .79) and -2.2 (95% CI -8.8 to 4.5, p = .51). CONCLUSIONS Levothyroxine in older adults with mild subclinical hypothyroidism provides no change in physical or mental fatigability.",2020,"After adjustment we found no between-group difference at 1 year on perceived physical (0.2; 95% CI -1.8 to 2.1; p = .88), or mental fatigability (-1.0; 95% CI -2.8 to 0.8; p = .26).","['community-dwelling participants aged ≥65 and older, with persistent subclinical hypothyroidism (TSH 4.60-19.99 mIU/L, normal free thyroxine levels) from Switzerland and Ireland', 'Older Adults With Subclinical Hypothyroidism', 'older adults with mild subclinical hypothyroidism']","['levothyroxine', 'Placebo', 'Levothyroxine', 'Thyroid Hormone Therapy', 'placebo']","['mental fatigability', 'change in physical and mental fatigability using the Pittsburgh Fatigability Scale', 'mean ± standard deviation (SD) TSH']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0439462', 'cui_str': 'mIU/L'}, {'cui': 'C0861033', 'cui_str': 'Thyroxine free normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",230.0,0.736424,"After adjustment we found no between-group difference at 1 year on perceived physical (0.2; 95% CI -1.8 to 2.1; p = .88), or mental fatigability (-1.0; 95% CI -2.8 to 0.8; p = .26).","[{'ForeName': 'Mirah J', 'Initials': 'MJ', 'LastName': 'Stuber', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Del Giovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'Departments of Medicine and Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes, Nutrition and Therapeutic Education, Geneva University Hospitals, Switzerland.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Internal Medicine, Section Gerontology and Geriatrics, Leiden University Center, the Netherlands.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Mooijaart', 'Affiliation': 'Department of Internal Medicine, Section Gerontology and Geriatrics, Leiden University Center, the Netherlands.'}, {'ForeName': 'Vera J C', 'Initials': 'VJC', 'LastName': 'McCarthy', 'Affiliation': 'School of Nursing and Midwifery, University College Cork, Ireland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, Switzerland.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular Medicine, University of Glasgow, Scotland.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of Epidemiology, Center for Aging and Population Health, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Ireland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa123'] 2423,32577927,How biased are you? The effect of prior performance information on attending physician ratings and implications for learner handover.,"Learner handover (LH), the process of sharing of information about learners between faculty supervisors, allows for longitudinal assessment fundamental in the competency-based education model. However, the potential to bias future assessments has been raised as a concern. The purpose of this study is to determine whether prior performance information such as LH influences the assessment of learners in the clinical context. Between December 2017 and June 2018, forty-two faculty members and final-year residents from the Department of Medicine at the University of Ottawa were assigned to one of three study groups through quasi-randomisation, taking into account gender, speciality and rater experience. In a counter-balanced design, each group received either positive, negative or no LH prior to watching six simulated learner-patient encounter videos. Participants rated each video using the mini-CEX and completed a questionnaire on the raters' general impressions of LH. A significant difference in the mean mini-CEX competency scale scores between the negative (M = 5.29) and positive (M = 5.97) LH groups (P < .001, d = 0.81) was noted. Similar findings were found for the single overall clinical competence ratings. In the post-study questionnaire, 22/28 (78%) of participants had correctly deduced the purpose of the study and 14/28 (50%) felt LH did not influence their assessment. LH influenced mini-CEX scores despite raters' awareness of the potential for bias. These results suggest that LH could influence a rater's performance assessment and careful consideration of the potential implications of LH is required.",2020,"A significant difference in the mean mini-CEX competency scale scores between the negative (M = 5.29) and positive (M = 5.97) LH groups (P < .001, d = 0.81) was noted.","['attending physician ratings and implications for learner handover', 'Between December 2017 and June 2018, forty-two faculty members and final-year residents from the Department of Medicine at the University of Ottawa']","['positive, negative or no LH prior to watching six simulated learner-patient encounter videos', 'LH']","['LH influenced mini-CEX scores', 'mean mini-CEX competency scale scores']","[{'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0275118,"A significant difference in the mean mini-CEX competency scale scores between the negative (M = 5.29) and positive (M = 5.97) LH groups (P < .001, d = 0.81) was noted.","[{'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, ON, Canada. tashaw@toh.ca.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wood', 'Affiliation': 'Department of Innovation in Medical Education, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Touchie', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Pugh', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Humphrey-Murto', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, ON, Canada.'}]",Advances in health sciences education : theory and practice,['10.1007/s10459-020-09979-6'] 2424,32577998,A Holistic Self-learning Approach for Young Adult Depression and Anxiety Compared to Medication-Based Treatment-As-Usual.,"A package of biopsychosocial services for young adults experiencing psychological distress was evaluated and compared to usual outpatient psychiatric care. Young adults (18-25) with moderate-to-severe symptoms of depression and/or anxiety (n = 26) were enrolled in a 13-week intervention consisting of nutritional coaching and multi-vitamin supplements, weekly educational and peer support groups, and a modest financial stipend to engage with physical or expressive activities. A comparison group (n = 13) continued with their usual medication-based outpatient care. Program participants reported significantly improved depression, anxiety, severity of distress, overall quality of life, and empowerment over 4 months, with progress maintained or further improved at 2-month follow-up. No evidence of change on any outcome was observed for comparison group participants. Although long-term impacts on mental health trajectories and reliance on psychotropic medications remain unknown, a holistic self-learning approach is a viable alternative to standard outpatient psychiatric care for young adults.",2020,"Program participants reported significantly improved depression, anxiety, severity of distress, overall quality of life, and empowerment over 4 months, with progress maintained or further improved at 2-month follow-up.","['young adults experiencing psychological distress', 'young adults', 'Young adults (18-25) with moderate-to-severe symptoms of depression and/or anxiety (n\u2009=\u200926']","['Holistic Self-learning Approach', 'nutritional coaching and multi-vitamin supplements, weekly educational and peer support groups, and a modest financial stipend to engage with physical or expressive activities']","['depression, anxiety, severity of distress, overall quality of life, and empowerment']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",26.0,0.0179231,"Program participants reported significantly improved depression, anxiety, severity of distress, overall quality of life, and empowerment over 4 months, with progress maintained or further improved at 2-month follow-up.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'School of Social Work, Colorado State University, 1586 Campus Delivery, Fort Collins, CO, 80523, USA. Shannon.hughes@colostate.edu.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rondeau', 'Affiliation': 'Wholeness Center, Fort Collins, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Shannon', 'Affiliation': 'Wholeness Center, Fort Collins, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sharp', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ivins', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, USA.'}, {'ForeName': 'JeongJin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Taylor', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, USA.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Bendixsen', 'Affiliation': 'MAPS MDMA-Assisted Psychotherapy Research, Fort Collins, USA.'}]",Community mental health journal,['10.1007/s10597-020-00666-9'] 2425,32578029,"Reminiscence therapy-based care program relieves post-stroke cognitive impairment, anxiety, and depression in acute ischemic stroke patients: a randomized, controlled study.","BACKGROUND Cognitive and mental impairments are common health problems in acute ischemic stroke (AIS) patients. In this study, we aimed to assess the benefit of a reminiscence therapy-based care (RTBC) program on cognitive impairment restoration, anxiety, and depression reduction in AIS patients. METHODS Totally 130 AIS patients were recruited in this randomized, controlled study and randomly assigned to the RTBC group or control group in 1:1 ratio for 12-month intervention. Mini-Mental State Examination (MMSE), Montreal cognitive assessment (MoCA), Hospital Anxiety and Depression Scale for anxiety/depression (HADS-A/HADS-D), and Zung self-rating anxiety/depression scale (SAS/SDS) were assessed at month 0 (M0), M3, M6, M9, and M12. Meanwhile, patients' satisfaction was also evaluated at M3, M6, M9, and M12. RESULTS RTBC increased MMSE score and MoCA score and reduced cognitive impairment patients' percentage assessed by MoCA score at M12 compared with control. RTBC reduced HADS-A score at M12, but not anxiety patients' percentage or severity by HADS-A at M12; besides, RTBC significantly lowered the SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS at M12 compared with control. RTBC reduced HADS-D score at M9 and M12 (while statistically non-significant), but not depression patients' percentage or severity by HADS-D at M12; it decreased SDS score at M9 and M12, but not depression patients' percentage or severity by SDS at M12 compared with control. Additionally, RTBC obsessed higher patients' satisfaction at M3, M6, and M12 compared with control. CONCLUSION RTBC could help reduce cognitive impairment, anxiety, and depression in post-stroke management for AIS patients.",2020,"RTBC reduced HADS-A score at M12, but not anxiety patients' percentage or severity by HADS-A at M12; besides, RTBC significantly lowered the SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS at M12 compared with control.","['acute ischemic stroke patients', 'acute ischemic stroke (AIS) patients', 'Totally 130 AIS patients', 'AIS patients']","['Reminiscence therapy-based care program', 'RTBC', 'reminiscence therapy-based care (RTBC) program']","['RTBC reduced HADS-D score', 'cognitive impairment restoration, anxiety, and depression reduction', 'MoCA score', ""SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS"", 'MMSE score and MoCA score', 'Mini-Mental State Examination (MMSE), Montreal cognitive assessment (MoCA), Hospital Anxiety and Depression Scale for anxiety/depression (HADS-A/HADS-D), and Zung self-rating anxiety/depression scale (SAS/SDS', 'RTBC reduced HADS-A score', 'cognitive impairment, anxiety, and depression', 'SDS score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}]",130.0,0.03323,"RTBC reduced HADS-A score at M12, but not anxiety patients' percentage or severity by HADS-A at M12; besides, RTBC significantly lowered the SAS score at M9 and M12, and anxiety patients' percentage and severity by SAS at M12 compared with control.","[{'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Harbin Medical University, 246 Xuefu Road, Harbin, 150001, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Harbin Medical University, 246 Xuefu Road, Harbin, 150001, China. xintong2871964996@163.com.'}]",Irish journal of medical science,['10.1007/s11845-020-02273-9'] 2426,32578037,Clinical Trial on Mindfulness with Family Caregivers for Patients with Cancer.,"To examine the effectiveness of a brief mindfulness-based interventions (MBIs) and educational interventions (EI) on self-efficacy and burden among family caregivers (FCs) of patients with cancer in Jordan. A quasi-experimental design was conducted. Two interventions were performed: the brief MBIs and the EIs were applied. A sampling of 138 FCs completed the study interventions. The FCs in the mindfulness group demonstrated a significant improvement in measures of self-efficacy and reduction in burden scores. Furthermore, in the EI group, only self-efficacy was significantly higher in the post-test. Burden reduction was significantly higher in the EI group than the mindfulness group. Appropriate supportive interventions should be directed to improve self-efficacy and reduce burden to assist FCs to carry out their crucial role in providing care for their patients.",2020,Burden reduction was significantly higher in the EI group than the mindfulness group.,"['138 FCs completed the study interventions', 'family caregivers (FCs) of patients with cancer in Jordan', 'Patients with Cancer']",['brief mindfulness-based interventions (MBIs) and educational interventions (EI'],"['self-efficacy and reduction in burden scores', 'Burden reduction', 'self-efficacy']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0118706,Burden reduction was significantly higher in the EI group than the mindfulness group.,"[{'ForeName': 'Muayyad M', 'Initials': 'MM', 'LastName': 'Ahmad', 'Affiliation': 'Clinical Nursing Department, School of Nursing, The University of Jordan, Amman, 11942, Jordan. mma4@ju.edu.jo.'}, {'ForeName': 'Laila I', 'Initials': 'LI', 'LastName': 'Al-Daken', 'Affiliation': 'College of Nursing, Sultan Qaboos University, Muscat, Oman.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01812-3'] 2427,32576202,Pre-implementation adaptation of primary care cancer prevention clinical decision support in a predominantly rural healthcare system.,"BACKGROUND Cancer is a leading cause of death in the United States. Primary care providers (PCPs) juggle patient cancer prevention and screening along with managing acute and chronic health problems. However, clinical decision support (CDS) may assist PCPs in addressing patients' cancer prevention and screening needs during short clinic visits. In this paper, we describe pre-implementation study design and cancer screening and prevention CDS changes made to maximize utilization and better fit a healthcare system's goals and culture. We employed the Consolidated Framework for Implementation Research (CFIR), useful for evaluating the implementation of CDS interventions in primary care settings, in understanding barriers and facilitators that led to those changes. METHODS In a three-arm, pragmatic, 36 clinic cluster-randomized control trial, we integrated cancer screening and prevention CDS and shared decision-making tools (SDMT) into an existing electronic medical record-linked cardiovascular risk management CDS system. The integrated CDS is currently being tested within a predominately rural upper Midwestern healthcare system. Prior to CDS implementation, we catalogued pre-implementation changes made from 2016 to 2018 based on: pre-implementation site engagement; key informant interviews with healthcare system rooming staff, providers, and leadership; and pilot testing. We identified influential barriers, facilitators, and changes made in response through qualitative content analysis of meeting minutes and supportive documents. We then coded pre-implementation changes made and associated barriers and facilitators using the CFIR. RESULTS Based on our findings from system-wide pre-implementation engagement, pilot testing, and key informant interviews, we made changes to accommodate the needs of the healthcare system based on barriers and facilitators that fell within the Intervention Characteristics, Inner Setting, and Outer Setting CFIR domains. Changes included replacing the expansion of medical assistant roles in one intervention arm with targeted SDMT, as well as altering cancer prevention CDS and study design elements. CONCLUSIONS Pre-implementation changes to CDS may help meet healthcare systems' evolving needs and optimize the intervention by being responsive to real-world implementation barriers and facilitators. Frameworks like the CFIR are useful tools for identifying areas where pre-implementation barriers and facilitators may result in design changes, both to research studies and CDS systems. TRIAL REGISTRATION NCT02986230.",2020,"Frameworks like the CFIR are useful tools for identifying areas where pre-implementation barriers and facilitators may result in design changes, both to research studies and CDS systems. ","['Primary care providers (PCPs) juggle patient cancer prevention and screening along with managing acute and chronic health problems', 'predominately rural upper Midwestern healthcare system']",['integrated cancer screening and prevention CDS and shared decision-making tools (SDMT) into an existing electronic medical record-linked cardiovascular risk management CDS system'],[],"[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}]",[],,0.0506432,"Frameworks like the CFIR are useful tools for identifying areas where pre-implementation barriers and facilitators may result in design changes, both to research studies and CDS systems. ","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Harry', 'Affiliation': 'Essentia Health, Essentia Institute of Rural Health, 6AV-2, 502 East Second Street, Duluth, MN, 55805, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Saman', 'Affiliation': 'Essentia Health, Essentia Institute of Rural Health, 6AV-2, 502 East Second Street, Duluth, MN, 55805, USA. Daniel.Saman@EssentiaHealth.org.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Truitt', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'Clayton I', 'Initials': 'CI', 'LastName': 'Allen', 'Affiliation': 'Essentia Health, Essentia Institute of Rural Health, 6AV-2, 502 East Second Street, Duluth, MN, 55805, USA.'}, {'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Walton', 'Affiliation': 'Essentia Health, Essentia Institute of Rural Health, 6AV-2, 502 East Second Street, Duluth, MN, 55805, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Ekstrom', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bianco', 'Affiliation': 'Essentia Health - Ely Clinic, 300 W Conan Street, Ely, MN, 55731, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Elliott', 'Affiliation': 'HealthPartners Institute, 3311 E. Old Shakopee Road, Bloomington, MN, 55425, USA.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01136-8'] 2428,32576214,Tracking implementation strategies in the randomized rollout of a Veterans Affairs national opioid risk management initiative.,"BACKGROUND In 2018, the Department of Veterans Affairs (VA) issued Notice 2018-08 requiring facilities to complete ""case reviews"" for Veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as high risk for adverse outcomes among patients prescribed opioids. Half of the facilities were randomly assigned to a Notice version including additional oversight. We evaluated implementation strategies used, whether strategies differed by randomization arm, and which strategies were associated with case review completion rates. METHODS Facility points of contact completed a survey assessing their facility's use of 68 implementation strategies based on the Expert Recommendations for Implementing Change taxonomy. We collected respondent demographic information, facility-level characteristics, and case review completion rates (percentage of high-risk patients who received a case review). We used Kruskal-Wallis tests and negative binomial regression to assess strategy use and factors associated with case reviews. RESULTS Contacts at 89 of 140 facilities completed the survey (64%) and reported using a median of 23 (IQR 16-31) strategies. The median case review completion rate was 71% (IQR 48-95%). Neither the number or types of strategies nor completion rates differed by randomization arm. The most common strategies were using the STORM dashboard (97%), working with local opinion leaders (80%), and recruiting local partners (80%). Characteristics associated with case review completion rates included respondents being ≤ 35 years old (incidence rate ratio, IRR 1.35, 95% CI 1.09-1.67) and having < 5 years in their primary role (IRR 1.23; 95% CI 1.01-1.51), and facilities having more prior academic detailing around pain and opioid safety (IRR 1.40, 95% CI 1.12-1.75). Controlling for these characteristics, implementation strategies associated with higher completion rates included (1) monitoring and adjusting practices (adjusted IRR (AIRR) 1.40, 95% CI 1.11-1.77), (2) identifying adaptations while maintaining core components (AIRR 1.28, 95% CI 1.03-1.60), (3) conducting initial training (AIRR 1.16, 95% CI 1.02-1.50), and (4) regularly sharing lessons learned (AIRR 1.32, 95% CI 1.09-1.59). CONCLUSIONS In this national evaluation of strategies used to implement case reviews of patients at high risk of opioid-related adverse events, point of contact age and tenure in the current role, prior pain-related academic detailing at the facility, and four specific implementation strategies were associated with case review completion rates, while randomization to additional centralized oversight was not. TRIAL REGISTRATION This project is registered at the ISRCTN Registry with number ISRCTN16012111. The trial was first registered on May 3, 2017.",2020,"Characteristics associated with case review completion rates included respondents being ≤ 35 years old (incidence rate ratio, IRR 1.35, 95% CI 1.09-1.67) and having < 5 years in their primary role (IRR 1.23; 95% CI 1.01-1.51), and facilities having more prior academic detailing around pain and opioid safety (IRR 1.40, 95% CI 1.12-1.75).","[""Facility points of contact completed a survey assessing their facility's use of 68 implementation strategies based on the Expert Recommendations for Implementing Change taxonomy""]",[],"['number or types of strategies nor completion rates', 'median case review completion rate', 'facilities having more prior academic detailing around pain and opioid safety']","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008903', 'cui_str': 'classification'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.246501,"Characteristics associated with case review completion rates included respondents being ≤ 35 years old (incidence rate ratio, IRR 1.35, 95% CI 1.09-1.67) and having < 5 years in their primary role (IRR 1.23; 95% CI 1.01-1.51), and facilities having more prior academic detailing around pain and opioid safety (IRR 1.40, 95% CI 1.12-1.75).","[{'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Rogal', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA. shari.rogal@va.gov.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chinman', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Walid F', 'Initials': 'WF', 'LastName': 'Gellad', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Mor', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'McCarthy', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Genna T', 'Initials': 'GT', 'LastName': 'Mauro', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Hale', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}, {'ForeName': 'Eleanor T', 'Initials': 'ET', 'LastName': 'Lewis', 'Affiliation': 'VA Office of Mental Health and Suicide Prevention, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Oliva', 'Affiliation': 'VA Office of Mental Health and Suicide Prevention, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}, {'ForeName': 'Jodie A', 'Initials': 'JA', 'LastName': 'Trafton', 'Affiliation': 'VA Office of Mental Health and Suicide Prevention, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Yakovchenko', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Gordon', 'Affiliation': 'Program for Addiction Research, Clinical Care, Knowledge, and Advocacy, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Leslie R M', 'Initials': 'LRM', 'LastName': 'Hausmann', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01005-y'] 2429,32576219,"Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study).","BACKGROUND Epidermolysis bullosa (EB) is a rare genetic disorder that manifests as blistering and/or skin erosion. There is no approved treatment for EB; current standard of care consists of wound and pain management. SD-101 6% is a topical cream containing 6% allantoin that was developed for treating skin lesions in patients with EB. The aim of this phase 3, multicenter, randomized, double-blind, vehicle-controlled study was to assess the efficacy and safety of SD-101 6% cream versus vehicle (0% allantoin) on lesions in patients with EB. METHODS Eligible patients were ≥1 month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50 cm 2 in size that was present for ≥21 days. Patients were randomly assigned to SD-101 6% cream or vehicle, which was applied topically once a day to the entire body for 3 months. Primary efficacy endpoints were time to complete target wound closure within 3 months and the proportion of patients who experienced complete target wound closure within 3 months. Post hoc subgroup analyses were conducted by patient age and in those with body surface area index of total body wound burden ≥5% at baseline. RESULTS In total, 169 patients were enrolled and randomly assigned to SD-101 6% (n = 82) or vehicle (n = 87). Baseline demographics and disease characteristics were similar between treatment groups. There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733 [0.365, 1.474]; nominal P = 0.390). A positive trend toward faster wound closure with SD-101 6% versus vehicle was observed in patients aged 2 to <12 years and those with total body wound burden ≥5% at baseline. SD-101 6% cream was well tolerated. CONCLUSIONS SD-101 6% cream for treatment of EB-associated lesions was not more effective than vehicle in shortening the time to complete target wound closure or achieving complete target wound closure within 3 months. TRIAL REGISTRATION ClinicalTrials.gov, NCT02384460; Date of trial registration, February 13, 2015; First participant enrolled, March 11, 2015.",2020,"There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733","['patients with EB.\nMETHODS\n\n\nEligible patients were\u2009≥1\u2009month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50\u2009cm 2 in size that was present for ≥21\u2009days', 'February 13, 2015; First participant enrolled, March 11, 2015', 'patients with epidermolysis bullosa', 'patients with EB', '169 patients']","['SD-101 6% cream versus vehicle (0% allantoin', 'SD-101 6% cream or vehicle', 'investigational topical cream SD-101 (6% allantoin']","['Baseline demographics and disease characteristics', 'Efficacy and tolerability', 'tolerated', 'skin lesions', 'efficacy and safety', 'time to target wound closure', 'time to complete target wound closure within 3\u2009months and the proportion of patients who experienced complete target wound closure', 'faster wound closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014527', 'cui_str': 'Epidermolysis bullosa'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",169.0,0.658526,"There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA. apaller@northwestern.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browning', 'Affiliation': 'Texas Dermatology & Laser Specialists, San Antonio, TX, USA.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Nikolic', 'Affiliation': 'Clinical Center of Serbia, Department of Dermatology, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bodemer', 'Affiliation': 'EB Reference Centre, Department of Dermatology, University Hospital Necker Enfants Malades, Paris, France.'}, {'ForeName': 'Dedee F', 'Initials': 'DF', 'LastName': 'Murrell', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Willistine', 'Initials': 'W', 'LastName': 'Lenon', 'Affiliation': 'Scioderm-An Amicus Therapeutics Company, Durham, NC, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Krusinska', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Reha', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Hjalmar', 'Initials': 'H', 'LastName': 'Lagast', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Barth', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01419-3'] 2430,32576225,ALICE: a randomized placebo-controlled phase II study evaluating atezolizumab combined with immunogenic chemotherapy in patients with metastatic triple-negative breast cancer.,"BACKGROUND Immunotherapy with checkpoint inhibitors (CI) represents an important novel development in cancer treatment. Metastatic triple-negative breast cancer (mTNBC) is incurable, with a median survival of only ~ 13 months. We have initiated the randomized placebo-controlled phase IIb study ALICE, evaluating PD-L1 blockade combined with immunogenic chemotherapy in mTNBC patients (n = 75). Intriguingly, the host immune response is strongly predictive for the effect of chemotherapy in mTNBC. In the ALICE trial, we release the brake on the immune response by use of atezolizumab, an inhibitory antibody against PD-L1. We utilize anthracyclines, shown to trigger the immune system, and low-dose cyclophosphamide, which has been reported to counter immunosuppressive cells. METHODS ALICE is a randomized, double-blind, placebo-controlled exploratory phase II study evaluating the safety and efficacy of atezolizumab when combined with immunogenic chemotherapy in subjects with mTNBC. The trial will enroll 75 evaluable subjects, randomized 2:3 into two arms (A:B). The patients receive identical chemotherapy, i.e. pegylated liposomal doxorubicin (PLD 20 mg/m 2 intravenously every 2nd week) + cyclophosphamide (50 mg per day, first 2 weeks in each 4 week cycle). Patients in arm A receive placebo, while patients in arm B receive atezolizumab. The primary objectives are assessment of toxicity and progression-free survival. The secondary objectives include overall survival, tumor response rate, clinical benefit rate, patient reported outcomes, biomarkers and assessment of tumor-immune evolution during therapy. DISCUSSION The question of how CI should be combined with chemotherapy, is a key challenge facing the field. There is a strong preclinical rationale for exploring if anthracyclines, which are considered to induce immunogenic cell death, synergize with PD-L1 blockade, and if low-dose cyclophosphamide counters tumor tolerance. However, the data from patients is as yet very limited, and the clinical evaluation of these hypotheses is among the key objectives in the ALICE trial. The study includes extensive biobanking and translational sub-projects, also addressing other clinically important questions. These analyses may uncover mechanisms of drug efficacy or tumor resistance, and identify biomarkers allowing personalized therapy. If the trial suggests acceptable safety of the ALICE therapy and provide a signal of clinical efficacy, further studies are warranted. Trial registration NCT03164993, May 24th 2017; https://clinicaltrials.gov/ct2/show/record/NCT03164993.",2020,"Metastatic triple-negative breast cancer (mTNBC) is incurable, with a median survival of only ~ 13 months.","['subjects with mTNBC', '75 evaluable subjects', 'patients with metastatic triple-negative breast cancer', 'mTNBC patients (n\u2009=\u200975']","['checkpoint inhibitors (CI', 'Metastatic triple-negative breast cancer (mTNBC', 'cyclophosphamide', 'atezolizumab', 'PD-L1 blockade combined with immunogenic chemotherapy', 'immunogenic chemotherapy', 'atezolizumab combined with immunogenic chemotherapy', 'identical chemotherapy, i.e. pegylated liposomal doxorubicin (PLD 20\xa0mg/m 2 intravenously every 2nd week)\u2009+\u2009cyclophosphamide', 'placebo']","['toxicity and progression-free survival', 'safety and efficacy', 'overall survival, tumor response rate, clinical benefit rate, patient reported outcomes, biomarkers and assessment of tumor-immune evolution during therapy']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': '1-dodecylpyridoxal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.252022,"Metastatic triple-negative breast cancer (mTNBC) is incurable, with a median survival of only ~ 13 months.","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kyte', 'Affiliation': 'Department of Clinical Cancer Research, Oslo University Hospital, Oslo, Norway. jonky@ous-hf.no.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Røssevold', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Falk', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Naume', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",Journal of translational medicine,['10.1186/s12967-020-02424-7'] 2431,30883486,Incremental Vestibulo-ocular Reflex Adaptation Training Dynamically Tailored for Each Individual.,"BACKGROUND AND PURPOSE Unilateral incremental vestibulo-ocular reflex (VOR) adaptation (IVA) increases the VOR gain (= eye/head velocity) for head rotations to one side by ∼10%. Prior IVA studies involved setting the initial VOR training gain demand at the subject's starting value (= 1 in a healthy subject), with the gain preset to increment by 0.1 every 90 seconds over 15 minutes, defined as Static IVA. We determined whether a dynamically calculated gain demand (= ""actual gain"" + 0.1) would result in greater adaptation, defined as Dynamic IVA. METHODS Using a hybrid video-oculography and StableEyes training system, we measured the active (self-generated head impulse) and passive (imposed, unpredictable head impulse) VOR gain in 8 healthy subjects before and after 15 minutes of Static (ie, preset) and Dynamic IVA training consisting of active, leftward and rightward, horizontal head impulses (peak amplitude 15°, peak velocity 150°/s, and peak acceleration 3000°/s). We also measured the active VOR gain during training. RESULTS The VOR gain increase toward the adapting side was ∼5% larger after Dynamic compared with Static IVA training (Dynamic: 13.9% ± 5.2%, Static: 9.4% ± 7.3%; P < 0.05). DISCUSSION AND CONCLUSIONS Our data suggest that 17°/s retinal image slip (due to the 0.1 gain difference between demand and actual gain) is sufficient to drive robust VOR adaptation. The implications for vestibular rehabilitation are that Dynamic IVA training not only produces better VOR adaptation but also allows more flexible training, for example, training can be spread over several smaller time blocks, without undoing prior adaptation.",2019,"The VOR gain increase toward the adapting side was ∼5% larger after Dynamic compared with Static IVA training (Dynamic: 13.9% ± 5.2%, Static: 9.4% ± 7.3%; P < 0.05). ",['8 healthy subjects'],"['hybrid video-oculography and StableEyes training system, we measured the active (self-generated head impulse) and passive (imposed, unpredictable head impulse']","['active VOR gain', 'VOR gain increase', 'VOR gain', 'VOR adaptation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034944', 'cui_str': 'Vestibulo-ocular reflex'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",8.0,0.0139625,"The VOR gain increase toward the adapting side was ∼5% larger after Dynamic compared with Static IVA training (Dynamic: 13.9% ± 5.2%, Static: 9.4% ± 7.3%; P < 0.05). ","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Todd', 'Affiliation': 'Balance and Vision Laboratory (C.J.T., W.V.C.F., A.A.M.), Neuroscience Research Australia, Sydney, New South Wales, Australia; University of New South Wales (A.A.M.), Sydney, New South Wales, Australia; Laboratory of Vestibular NeuroAdaptation (M.C.S.), Department of Otolaryngology-Head and Neck Surgery (A.A.M.), Johns Hopkins University, Baltimore, Maryland; Department of Physical Medicine and Rehabilitation (M.C.S.), Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Schubert', 'Affiliation': ''}, {'ForeName': 'William V C', 'Initials': 'WVC', 'LastName': 'Figtree', 'Affiliation': ''}, {'ForeName': 'Americo Aniello', 'Initials': 'AA', 'LastName': 'Migliaccio', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000269'] 2432,32583931,The effect of bright light therapy on depressive symptoms in adults with intellectual disabilities: Results of a multicentre randomized controlled trial.,"BACKGROUND Although a large number of adults with intellectual disabilities have depressive symptoms, non-pharmacological treatments are scarce. The present authors investigated whether bright light therapy (BLT) is effective in decreasing depressive symptoms compared to care as usual. METHODS This multicentre randomized controlled trial consisted of three study groups (10,000 lux BLT, dim light BLT and a no-BLT group). Participants received BLT for 30 min in the morning (14 consecutive days), additional to their regular care. Primary outcome was as follows: depressive symptoms measured with the ADAMS Depressive Mood subscale 1 week after the end of BLT (same time period in the no-BLT group). RESULTS Forty-one participants were included in our trial. In both BLT groups, a significant decrease in depressive symptoms was seen. No significant differences were found between 10,000 lux BLT and no-BLT (p = .199) and no significant differences between dim light BLT and no-BLT (p = .451). A minimum amount of side effects and no adverse events were reported. CONCLUSIONS In both BLT interventions, a decrease in depressive symptoms was seen. With 10,000 lux BLT, depressive symptoms decreased even below the clinical cut-off point, which makes BLT a promising intervention for clinical practice.",2020,"No significant differences were found between 10,000 lux BLT and no-BLT (p = .199) and no significant differences between dim light BLT and no-BLT (p = .451).","['Forty-one participants were included in our trial', 'adults with intellectual disabilities']","['BLT', 'bright light therapy (BLT', 'bright light therapy']","['Depressive Mood subscale', 'follows: depressive symptoms measured with the ADAMS', 'depressive symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}]",41.0,0.134288,"No significant differences were found between 10,000 lux BLT and no-BLT (p = .199) and no significant differences between dim light BLT and no-BLT (p = .451).","[{'ForeName': 'Pauline C M', 'Initials': 'PCM', 'LastName': 'Hamers', 'Affiliation': 'Department of General Practice, Intellectual Disability Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Dederieke A M', 'Initials': 'DAM', 'LastName': 'Festen', 'Affiliation': 'Department of General Practice, Intellectual Disability Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick J E', 'Initials': 'PJE', 'LastName': 'Bindels', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hermans', 'Affiliation': 'Department of General Practice, Intellectual Disability Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12770'] 2433,32577580,Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial.,"A quality metric for centers performing rectal cancer surgery is a high percentage of sphincter sparing procedures. These procedures often involve temporary bowel diversion to minimize the complications of an anastomotic leak. The most common strategy is a diverting loop ileostomy which is then closed after completion of adjuvant therapy or the patient recovers from surgery. Loop ileostomy is not without complications and the closure is complicated by a one in three chance of incisional hernia development. Strategies to prevent this problem have been designed using a variety of techniques with and without mesh placement. This proposed pilot study will test the safety and efficacy of a novel stoma closure technique involving permanent mesh in the retro rectus position during ileostomy closure. The study will prospectively follow 20 patients undergoing ileostomy closure using this technique and evaluate for safety of the procedure, quality of life, and feasibility for a larger randomized controlled trial. Patients will be followed post procedurally and evaluated for 30-day complications, as well as followed up with routine cancer surveillance computed tomography every 6 months in which the presence of stoma site incisional hernias will be evaluated. The results of this pilot study will inform the design of a multiple center, blinded randomized controlled trial to evaluate the utility of permanent mesh placement to decrease the incidence of prior stoma site incisional hernias.",2020,Loop ileostomy is not without complications and the closure is complicated by a one in three chance of incisional hernia development.,"['centers performing rectal cancer surgery', '20 patients undergoing']","['Stoma closure and reinforcement (SCAR', 'permanent mesh placement', 'ileostomy closure', 'novel stoma closure technique involving permanent mesh']","['30-day complications', 'safety and efficacy', 'incidence of prior stoma site incisional hernias']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3665863', 'cui_str': 'Stoma closure'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}]",20.0,0.157022,Loop ileostomy is not without complications and the closure is complicated by a one in three chance of incisional hernia development.,"[{'ForeName': 'Jenaya L', 'Initials': 'JL', 'LastName': 'Goldwag', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Srinivas J', 'Initials': 'SJ', 'LastName': 'Ivatury', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pauli', 'Affiliation': 'Department of Surgery, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Tsapakos', 'Affiliation': 'Department of Radiology, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Matthew Z', 'Initials': 'MZ', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100582'] 2434,32577581,Exploring human trainability: Design and rationale of Studies of Twin Responses to Understand Exercise as a Therapy (STRUETH) study.,"Background Exercise confers myriad health benefits and physical inactivity is a modifiable risk factor for many non-communicable chronic diseases. However, individual responsiveness to guideline-based exercise programs is idiosyncratic for health and fitness outcomes. It is not known whether the response of individuals to distinct exercise modalities tend to be concordant or whether there is a genetic contribution to variation in exercise responsiveness. Methods/design Healthy, young adult (16-40yrs) monozygotic (MZ) and dizygotic (DZ) twin pairs were recruited and randomly assigned to 3 months of endurance or resistance exercise training. Twin pairs trained together. After 3 months of training in their randomly assigned mode, a washout period of 3 months was observed before twin pairs crossed over to complete 3 months of the alternate exercise intervention. Measures of cardiac morphology and function, cerebrovascular function, cognitive performance, peripheral artery function, biochemistry, blood pressure, body composition, skeletal muscle strength and cardiopulmonary fitness were collected before and after each exercise intervention (i.e. at weeks 0, 12, 24 and 36). Discussion We adopted exercise modalities that produce distinct haemodynamic and physiological stimuli for physiological adaptation and recruited MZ and DZ twin pairs to address questions such as; do individuals exhibit concordant responses to distinct exercise modalities? and what is the genetic contribution to adaptation resulting from distinct training modalities? The results of this study will provide insight into the genetic and environmental contribution to exercise response to distinct modes of training, with implications for determining the optimal approaches to exercise prescription.",2020,We adopted exercise modalities that produce distinct haemodynamic and physiological stimuli for physiological adaptation and recruited MZ and DZ twin pairs to address questions such as; do individuals exhibit concordant responses to distinct exercise modalities? and what is the genetic contribution to adaptation resulting from distinct training modalities? ,"['Healthy, young adult (16-40yrs) monozygotic (MZ) and dizygotic (DZ) twin pairs']","['\n\n\nExercise', 'endurance or resistance exercise training']","['cardiac morphology and function, cerebrovascular function, cognitive performance, peripheral artery function, biochemistry, blood pressure, body composition, skeletal muscle strength and cardiopulmonary fitness']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0041429', 'cui_str': 'Fraternal twin'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.0371875,We adopted exercise modalities that produce distinct haemodynamic and physiological stimuli for physiological adaptation and recruited MZ and DZ twin pairs to address questions such as; do individuals exhibit concordant responses to distinct exercise modalities? and what is the genetic contribution to adaptation resulting from distinct training modalities? ,"[{'ForeName': 'Channa E', 'Initials': 'CE', 'LastName': 'Marsh', 'Affiliation': 'School of Human Sciences (Sport Science, Exercise and Health), The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Thomas', 'Affiliation': 'School of Human Sciences (Sport Science, Exercise and Health), The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Sport Science, Exercise and Health), The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Scurrah', 'Affiliation': 'Twins Research Australia, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Sport Science, Exercise and Health), The University of Western Australia, Perth, Western Australia, Australia.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100584'] 2435,32577615,"Comparison of pregnancy incidence among African women in a randomized trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) or a levonorgestrel (LNG) implant for contraception.","Objective The objective was to address bias in contraception efficacy studies through a randomized study trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) and a levonorgestrel (LNG) implant. Study design We analyzed data from the Evidence for Contraceptive Options and HIV Outcomes Trial, which assessed HIV incidence among 7829 women from 12 sites in eSwatini, Kenya, South Africa and Zambia seeking effective contraception and who consented to be randomized to DMPA-IM, copper IUD or LNG implant. We used Cox proportional hazards regression adjusted for condom use to compare pregnancy incidence during both perfect and typical (i.e., allowing temporary interruptions) use. Results A total of 7710 women contributed to this analysis. Seventy pregnancies occurred during perfect and 85 during typical use. There was no statistically significant difference in perfect use pregnancy incidence among the methods: 0.61 per 100 woman-years for DMPA-IM [95% confidence interval (CI) 0.36-0.96], 1.06 for copper IUD (95% CI 0.72-1.50) and 0.63 for LNG implants (95% CI 0.39-0.96). Typical use pregnancy rates were also largely similar: 0.87 per 100 woman-years for DMPA-IM (95% CI 0.58-1.25), 1.11 for copper IUD (95% CI 0.77-1.54) and 0.63 for LNG implants (95% CI 0.39-0.96). Conclusions In this randomized trial of highly effective contraceptive methods among African women, both perfect and typical use resulted in low pregnancy rates. Our findings provide strong justification for improving access to a broader range of longer-acting contraceptive options including LNG implants and copper IUD for African women. Implications statement Data from this study support recommendations to providers, policy makers and patients that all of these methods provide safe and highly effective contraception for African women.",2020,"There was no statistically significant difference in perfect use pregnancy incidence among the methods: 0.61 per 100 woman-years for DMPA-IM [95% confidence interval (CI) 0.36-0.96], 1.06 for copper IUD (95% CI 0.72-1.50) and 0.63 for LNG implants (95% CI 0.39-0.96).","['African women', '7829 women from 12 sites in eSwatini, Kenya, South Africa and Zambia seeking effective contraception and who consented to be randomized to', '7710 women contributed to this analysis']","['DMPA-IM, copper IUD or LNG implant', 'intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) or a levonorgestrel (LNG) implant', 'intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) and a levonorgestrel (LNG) implant']","['Typical use pregnancy rates', 'perfect use pregnancy incidence']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",7829.0,0.554475,"There was no statistically significant difference in perfect use pregnancy incidence among the methods: 0.61 per 100 woman-years for DMPA-IM [95% confidence interval (CI) 0.36-0.96], 1.06 for copper IUD (95% CI 0.72-1.50) and 0.63 for LNG implants (95% CI 0.39-0.96).","[{'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'Kenya Medical Research Institute Center for Microbiology Research, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': 'FHI 360, Durham, USA.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Heller', 'Affiliation': 'University of Washington, Seattle, USA.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'FHI 360, Durham, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Yacobson', 'Affiliation': 'FHI 360, Durham, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'University of Washington, Seattle, USA.'}, {'ForeName': 'Margaret Phiri', 'Initials': 'MP', 'LastName': 'Kasaro', 'Affiliation': 'UNC Global Projects Zambia & University of North Carolina at Chapel Hill, Zambia.'}, {'ForeName': 'Cheryl E', 'Initials': 'CE', 'LastName': 'Louw', 'Affiliation': 'Madibeng Centre for Research, Brits, South Africa.'}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Nhlabasti', 'Affiliation': 'Family Life Association of eSwatini & ICAP at Columbia University, eSwatini.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, School of Clinical Medicine, Johannesburg, South Africa.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Wakhungu', 'Affiliation': 'Kenya Medical Research Institute Center for Microbiology Research, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gichangi', 'Affiliation': 'International Center for Reproductive Health, Kenya.'}, {'ForeName': 'Nelly R', 'Initials': 'NR', 'LastName': 'Mugo', 'Affiliation': 'Kenya Medical Research Institute Center for Microbiology Research, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Morrison', 'Affiliation': 'FHI 360, Durham, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contraception: X,['10.1016/j.conx.2020.100026'] 2436,32577707,Effect of fluoride varnish with functionalized tri-calcium phosphate on post-orthodontic white spot lesions: an investigator-blinded controlled trial.,"OBJECTIVE To investigate the effect of a 5% sodium fluoride varnish with functionalized tri-calcium phosphate (fTCP) on post-orthodontic white spot lesions. A secondary aim was to study if the patients and their clinicians perceived clinical improvements. METHOD AND MATERIALS Sixty-four patients with at least two visible WSLs on their maxillary incisors, canines, or first premolars present at the debonding of fixed appliances (baseline) were enrolled and assigned to a Varnish group (Clinpro White Varnish, 3M Espe) receiving topical applications at baseline and after 8 weeks, or a Control group treated with a fluoride-free mock product. The primary endpoint was white spot lesion appearance after 16 weeks, assessed from photographs using the modified ICDAS white spot lesion score (0 to 3). The patients and the dental examiners rated the white spot lesions subjectively with aid of a visual analog scale. RESULTS Fifty-three patients completed the study. After 16 weeks, 62% of the white spot lesions in the Varnish group were completely reversed (score 0) compared to 39% in the Control group. The treatment effect was statistically significant (OR 0.22; 95% CI 0.08 to 0.59, P = .003) after adjusting for baseline oral hygiene index and type of tooth. A significant correlation (P < .05) was observed between patients' and orthodontists' perception of the lesions. CONCLUSION The 5% sodium fluoride varnish with fTCP appeared clinically effective in reversing post-orthodontic white spot lesions 16 weeks after debonding. The patients and the clinicians agreed on the obtained esthetic improvements.",2020,"A significant correlation (P < .05) was observed between patients' and orthodontists' perception of the lesions. ","['Sixty-four patients with at least two visible WSLs on their maxillary incisors, canines, or first premolars present at the debonding of fixed appliances (baseline', 'Fifty-three patients completed the study', 'post-orthodontic white spot lesions']","['sodium fluoride varnish with fTCP', '5% sodium fluoride varnish with functionalized tri-calcium phosphate (fTCP', 'Varnish group (Clinpro White Varnish, 3M Espe) receiving topical applications at baseline and after 8 weeks, or a Control group treated with a fluoride-free mock product', 'fluoride varnish with functionalized tri-calcium phosphate']","['white spot lesion appearance', 'white spot lesions subjectively with aid of a visual analog scale', 'modified ICDAS white spot lesion score']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.103072,"A significant correlation (P < .05) was observed between patients' and orthodontists' perception of the lesions. ","[{'ForeName': 'Olympia', 'Initials': 'O', 'LastName': 'Salamara', 'Affiliation': ''}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papadimitriou', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Mortensen', 'Affiliation': ''}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Twetman', 'Affiliation': ''}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Koletsi', 'Affiliation': ''}, {'ForeName': 'Sotiria', 'Initials': 'S', 'LastName': 'Gizani', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44810'] 2437,32578066,Impact of Perioperative Steroid Administration in Patients Undergoing Major Hepatectomy with Extrahepatic Bile Duct Resection: A Randomized Controlled Trial.,"BACKGROUND To date, five randomized controlled trials have assessed the clinical benefit of perioperative steroid administration in hepatectomy; however, all of these studies involved a substantial number of 'minor' hepatectomies. The benefit of steroid administration for patients undergoing 'complex' hepatectomy, such as major hepatectomy with extrahepatic bile duct resection, is still unclear. This study aimed to evaluate the clinical benefit of perioperative steroid administration for complex major hepatectomy. METHODS Patients with suspected hilar malignancy scheduled to undergo major hepatectomy with extrahepatic bile duct resection were randomized into either the control or steroid groups. The steroid group received hydrocortisone 500 mg immediately before hepatic pedicle clamping, followed by hydrocortisone 300 mg on postoperative day (POD) 1, 200 mg on POD 2, and 100 mg on POD 3. The control group received only physiologic saline. The primary endpoint was the incidence of postoperative liver failure. RESULTS A total of 94 patients were randomized to either the control (n = 46) or steroid (n = 48) groups. The two groups had similar baseline characteristics; however, there were no significant differences between the groups in the incidence of grade B/C postoperative liver failure (control group, n = 8, 17%; steroid group, n = 4, 8%; p = 0.188) and other complications. Serum bilirubin levels on PODs 2 and 3 were significantly lower in the steroid group than those in the control group; however, these median values were within normal limits in both groups. CONCLUSION Perioperative steroid administration did not reduce the risk of postoperative complications, including liver failure following major hepatectomy with extrahepatic bile duct resection.",2020,"Serum bilirubin levels on PODs 2 and 3 were significantly lower in the steroid group than those in the control group; however, these median values were within normal limits in both groups. ","['Patients Undergoing Major Hepatectomy with Extrahepatic Bile Duct Resection', '94 patients', ""patients undergoing 'complex' hepatectomy, such as major hepatectomy with extrahepatic bile duct resection"", 'Patients with suspected hilar malignancy scheduled to undergo major hepatectomy with extrahepatic bile duct resection', 'major hepatectomy with extrahepatic bile duct resection']","['steroid administration', 'steroid', 'control or steroid', 'hydrocortisone 500\xa0mg immediately before hepatic pedicle clamping, followed by hydrocortisone 300\xa0mg on postoperative day (POD', 'Perioperative Steroid Administration', 'physiologic saline']","['risk of postoperative complications', 'incidence of postoperative liver failure', 'Serum bilirubin levels', 'incidence of grade B/C postoperative liver failure', 'liver failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0206187', 'cui_str': 'Extrahepatic duct structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4081380', 'cui_str': 'Hydrocortisone 500 MG'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0441806', 'cui_str': 'Grade B'}]",94.0,0.0620577,"Serum bilirubin levels on PODs 2 and 3 were significantly lower in the steroid group than those in the control group; however, these median values were within normal limits in both groups. ","[{'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Onoe', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ebata', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Igami', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nagino', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. nagino@med.nagoya-u.ac.jp.'}]",Annals of surgical oncology,['10.1245/s10434-020-08745-7'] 2438,32578261,Social story-based oral health promotion for preschool children with special healthcare needs: A 24-month randomized controlled trial.,"OBJECTIVES This study aimed to investigate the efficacy of the social story-based intervention in promoting the oral health status among preschool children with special healthcare needs. METHODS The 24-month randomized controlled trial recruited 306 children from centres that provided educational training for 2- to 6-year-old children who had special healthcare needs. The participants received standardized toothbrushing training and oral health education materials. The education materials for children in the test group were validated social stories, while materials for children in the control group were standard leaflets. Those materials were introduced in each training session and used at home by parents. Children's oral health status and oral health-related behaviours were assessed before and after interventions. Data were analysed via generalized estimating equations, negative binomial regression and binary logistic regression. RESULTS There was no significant difference in caries experience among children in both groups after 24 months. However, children in the test group showed better oral hygiene status and better toothbrushing performance, and they were more likely to visit a dentist (OR = 2.00, 95% CI:1.15,3.49) than their peers in the control group. Caries progression was more likely to be observed among children who had low social skills or whose parents were not working full-time. Children from high-income families showed better oral hygiene status than their peers (Estimate = -0.11, 95%CI: -0.20,-0.01). CONCLUSION Social stories could be used to improve oral health-related behaviours among young children with SHCN. The efficacy of the intervention might be associated with children's adaptive skills and family socio-demographic status.",2020,"Children from high-income families showed better oral hygiene status than their peers (Estimate = -0.11, 95%CI: -0.20,-0.01). ","['306 children from centres that provided educational training for 2- to 6-year-old children who had special healthcare needs', 'preschool children with special healthcare needs', 'young children with SHCN']","['social story-based intervention', 'standardized toothbrushing training and oral health education materials', 'Social story-based oral health promotion']","['caries experience', 'oral health-related behaviours', 'Caries progression', ""Children's oral health status and oral health-related behaviours"", 'oral hygiene status', 'oral hygiene status and better toothbrushing performance', 'validated social stories']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]",306.0,0.0527307,"Children from high-income families showed better oral hygiene status than their peers (Estimate = -0.11, 95%CI: -0.20,-0.01). ","[{'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Paediatric Dentistry & Orthodontics, Faculty of Dentistry, 2/F Prince Philip Dental Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Hai Ming', 'Initials': 'HM', 'LastName': 'Wong', 'Affiliation': 'Paediatric Dentistry & Orthodontics, Faculty of Dentistry, 2/F Prince Philip Dental Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Periodontology and Public Health, Faculty of Dentistry, 2/F Prince Philip Dental Hospital, The University of Hong Kong, Hong Kong SAR, China.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12554'] 2439,32578279,Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07).,"OBJECTIVE We compared patients' preferences for intravenous (IV-t) versus subcutaneous (SC-t) trastuzumab administration. METHODS Phase III, open-label, multicentre study in HER2-positive metastatic breast cancer. Patients were receiving IV-t for at least 4 months without progression. Randomisation was 1:1 to administer 2 cycles of SC-t with vial followed by 2 cycles with single injection device (SID) or the reverse sequence (600mg SC-t every 3 weeks for 4 cycles). PRIMARY OBJECTIVE patients' preference for IV-t versus SC-t; secondary objectives: patients' preference for vial versus SID, healthcare professional (HCP) preference and safety. RESULTS We randomised 166 patients in 26 sites. Median number of previous lines of chemotherapy and/or endocrine therapy was 1 (1-7). Median duration of prior IV-t was 1.8 years (0.3-14). Of the159 patients completing the questionnaires, 86.2% preferred SC-t, 6.9% preferred IV-t, and 6.9% had no preference. Patients preferred SID (59.2%) over vial (26.3%). Most (87.2%) HCP preferred SC-t of whom 51.3% and 28.2% preferred SID and vial respectively. Related adverse events included G1-2 injection site reactions in 18 patients (10.8%), G1 pain in 8 (4.8%), G1-2 allergic reaction in 2 (1.2%), one G3 heart failure and 1 G2 ejection fraction decrease. CONCLUSIONS SC-t is preferred with no safety impact.",2020,"Related adverse events included G1-2 injection site reactions in 18 patients (10.8%), G1 pain in 8 (4.8%), G1-2 allergic reaction in 2 (1.2%), one G3 heart failure and 1 G2 ejection fraction decrease. ","['HER2-positive metastatic breast cancer patients', 'HER2-positive metastatic breast cancer', '166 patients in 26 sites']","['chemotherapy and/or endocrine therapy', 'intravenous (IV-t) versus subcutaneous (SC-t) trastuzumab administration', 'subcutaneous versus intravenous trastuzumab']","['G1-2 allergic reaction', ' preference for vial versus SID, healthcare professional (HCP) preference and safety', 'Median duration of prior IV-t', 'G1 pain', 'G3 heart failure and 1 G2 ejection fraction decrease']","[{'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0794888', 'cui_str': 'Injection device'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0743400', 'cui_str': 'Ejection fraction decreased'}]",,0.0805355,"Related adverse events included G1-2 injection site reactions in 18 patients (10.8%), G1 pain in 8 (4.8%), G1-2 allergic reaction in 2 (1.2%), one G3 heart failure and 1 G2 ejection fraction decrease. ","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Montaño', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'César A', 'Initials': 'CA', 'LastName': 'Rodríguez', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'González-Flores', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Garrigós', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Quiroga', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Antón', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Malón', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Chacón', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Velasco', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Gonzalez-Cortijo', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jolis', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Echarri', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Amigo', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Casas', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carrasco', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Casas', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Madrid, Spain.'}]",European journal of cancer care,['10.1111/ecc.13253'] 2440,32578325,Spaced education and student learning: Results from a medical school.,"BACKGROUND It is critical for medical students to retain and apply their knowledge of basic sciences to become competent prescribing physicians. Poor long-term retention is a pervasive concern. We investigated the impact of 'spaced education' teaching modules to improve knowledge retention in medical students on a topic of public health: vitamin D and its role in health and disease. It is critical for medical students to retain and apply their knowledge of basic sciences to become competent prescribing physicians METHODS: In a self-matched design, 148 medical students were randomised and evaluated on vitamin D-related topics to assess reinforced and non-reinforced knowledge in a multiple-choice question format. Initial learning and long-term retention were assessed with an estimation of Cohen's effect size at 24 and 72 weeks, respectively. RESULTS The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33). Although the scores dipped, there was a retention of knowledge at 72 weeks (effect size = 0.48). DISCUSSION Spaced reinforcement and testing statistically improved knowledge retention among our medical students. Gaps in the present teaching could be bridged by motivating the students to extend their learning time by appropriate spacing intervals and to understand the relevance of course content in different scenarios as a physician. Further research could be instrumental in optimising interventions to enhance learning opportunities for medical students.",2020,"The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33).","['medical students on a topic of public health', 'medical students', '148 medical students']",['vitamin\xa0D-related topics to assess reinforced and non-reinforced knowledge'],"['knowledge retention', 'Initial learning and long-term retention', 'retention of knowledge', 'composite formative test scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",148.0,0.028314,"The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33).","[{'ForeName': 'Preeta K', 'Initials': 'PK', 'LastName': 'Chugh', 'Affiliation': 'Department of Pharmacology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Dehli, India.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Tripathi', 'Affiliation': 'Department of Pharmacology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Dehli, India.'}]",The clinical teacher,['10.1111/tct.13180'] 2441,32578478,Inclusion of Resistance Routines in a Hypoxia Training Program Does not Interfere with Prevention of Acute Mountain Sickness.,"OBJECTIVES Acclimatization strategies have been shown to be the best solutions to avoid acute mountain sickness. In this context, we have designed a protocol performed in hypoxia that includes resistance routines in combination with classical endurance training exercises with mountain trekking at mid altitude. METHODS Thirty-two volunteers preparing different mountain expeditions participated in the study, distributed into 2 groups. One group trained at 2000 m, while another group trained at 4500-5800 m of simulated altitude in a hypoxic chamber. Acute mountain sickness was monitored by answering the Lake Louise Scale questionnaire during 2 sleeping sessions at 4800 m of simulated altitude at the beginning and at the end of the study. At the same time, oxygen saturation was determined in both groups to monitor physiologic adaptation. Data were also collected from the base camps in each expedition before ascension. RESULTS Acute mountain sickness incidence in the hypoxic group decreased from 100% at the beginning to 12 % of individuals at the end of the training period, and it was 25% at the base camps of expeditions. On the other hand, the control group passed from 100% to 88% of individuals at the end of the intervention and 70% at the base camps. At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group. These data were supported by the oxygen saturation values, indicating adequate adaptation changes for altitude in the hypoxic group. CONCLUSION The inclusion of resistance workouts in combination with endurance exercises, all performed in hypoxic conditions, does not interfere with an optimal adaptation to altitude and to prevent acute mountain sickness.",2020,"At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group.","['with mountain trekking at mid altitude', 'Thirty-two volunteers preparing different mountain expeditions participated in the study, distributed into 2 groups']","['classical endurance training exercises', 'Hypoxia Training Program']","['Acute mountain sickness', 'Lake Louise Scale questionnaire', 'acute mountain sickness severity', 'oxygen saturation', 'Acute mountain sickness incidence']","[{'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015315', 'cui_str': 'Expeditions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",32.0,0.0122975,"At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group.","[{'ForeName': 'Aritz', 'Initials': 'A', 'LastName': 'Urdampilleta', 'Affiliation': 'ElikaEsport®. Nutrition, Innovation and Sport , Barcelona, Spain.'}, {'ForeName': 'Patxi', 'Initials': 'P', 'LastName': 'León-Guereño', 'Affiliation': 'Department of Psychology. University of Deusto, Donostia-San Sebastian, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Calleja-González', 'Affiliation': 'Department of Physical Education and Sports. University of Basque Country (UPV-EHU) . Vitoria, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Roche', 'Affiliation': 'Department of Applied Biology-Nutrition, Institute of Bioengineering, University Miguel Hernandez (Elche). Alicante Institute for Health and Biomedical Research (ISABIAL) , Alicante Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology. Faculty of Physical Therapy, University of Valladolid. Soria (Spain) .'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1786344'] 2442,32578488,"Influence of a Novel Food-Grade Formulation of Red Chili Extract ( Capsicum annum ) on Overweight Subjects: Randomized, Double-Blinded, Placebo-Controlled Study.","Capsaicinoids from pungent red chilies ( Capsicum annum and Capsicum frutescens ) have received significant attention as a natural supplement for the management of obesity. However, the consumption of chili extract at physiologically relevant dosage of capsaicinoids is a challenge owing to its pungency and gastrointestinal discomforts. The present study reports the systemic absorption, safety and influence of a novel, food-grade, and sustained-release formulation of capsaicinoids-rich red chili extract using fenugreek dietary fiber (Capsifen ® ). Twenty-four healthy overweight subjects were randomized into placebo ( n  = 12) and Capsifen ( n  = 12) groups and supplemented with 200 mg × 1/day of Capsifen (4 mg capsaicinoids/day) for 28 days. Influence of Capsifen on eating behavior and appetite was followed by Three-Factor Eating Questionnaire (TFEQ) and Council of Nutrition Appetite Questionnaire (CNAQ), respectively. Consumption of Capsifen did not reveal any adverse events or deviations in hematology and biochemical parameters related to safety. However, a significant decrease in body weight (2.1%), w/h ratio (4%) and body mass index (BMI) (2.2%) were observed among Capsifen group when compared to placebo. The TFEQ and appetite analysis revealed a significant improvement in uncontrolled eating and reduction in appetite among Capsifen subjects. The UPLC-ESI-MS/MS analysis confirmed the absorption of capsaicinoids from CAP supplementation. The study further demonstrated the safety and tolerability of Capsifen at the investigational dosage. Thus, the significant reduction in anthropometric parameters such as body weight, w/h ratio, and BMI along with the improvement in eating behaviour as well as appetite, indicated the potential body weight management effect of Capsifen.",2020,"However, a significant decrease in body weight (2.1%), w/h ratio (4%) and body mass index (BMI) (2.2%) were observed among Capsifen group when compared to placebo.","['Overweight Subjects', 'Twenty-four healthy overweight subjects']","['Placebo', 'capsaicinoids-rich red chili extract using fenugreek dietary fiber (Capsifen ® ', 'Capsifen ( n \u2009=\u200912) groups and supplemented with 200\u2009mg × 1/day of Capsifen', 'Novel Food-Grade Formulation of Red Chili Extract ( Capsicum annum ', 'Capsifen', 'placebo']","['safety and tolerability of Capsifen', 'uncontrolled eating and reduction in appetite', 'body weight', 'Factor Eating Questionnaire (TFEQ) and Council of Nutrition Appetite Questionnaire (CNAQ', 'eating behavior and appetite', 'anthropometric parameters such as body weight, w/h ratio, and BMI', 'body mass index (BMI']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0060207', 'cui_str': 'Fenugreek'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0006932', 'cui_str': 'Capsicum'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0474423', 'cui_str': 'Eating behavior and appetite'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",24.0,0.0357105,"However, a significant decrease in body weight (2.1%), w/h ratio (4%) and body mass index (BMI) (2.2%) were observed among Capsifen group when compared to placebo.","[{'ForeName': 'Ashil', 'Initials': 'A', 'LastName': 'Joseph MSc', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, Kerala, India.'}, {'ForeName': 'Febi', 'Initials': 'F', 'LastName': 'John PhD', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, Kerala, India.'}, {'ForeName': 'Jestin V', 'Initials': 'JV', 'LastName': 'Thomas MSc', 'Affiliation': 'Leads Clinical Research and Bio Services Pvt. Ltd., Bangalore, Karnataka, India.'}, {'ForeName': 'Syam Das PhD', 'Initials': 'SDP', 'LastName': 'Sivadasan', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, Kerala, India.'}, {'ForeName': 'Balu', 'Initials': 'B', 'LastName': 'Maliakel PhD', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, Kerala, India.'}, {'ForeName': 'Ratheesh', 'Initials': 'R', 'LastName': 'Mohan PhD', 'Affiliation': 'St. Thomas College, Kottayam, Kerala, India.'}, {'ForeName': 'Krishnakumar', 'Initials': 'K', 'LastName': 'I M', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, Kerala, India.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1780363'] 2443,32578496,Feasibility of the Lee Silverman Voice Treatment-BIG Intervention in Stroke.,"Lee Silverman Voice Treatment-BIG (LSVT BIG) has been used in Parkinson's disease and in two case studies with individuals post-stroke. The purpose of this study was to examine the feasibility, acceptability, and preliminary clinical effect of the LSVT BIG program for individuals post-stroke. This study was a waitlist crossover design. Outcomes were assessed at baseline, after 4 weeks, and after crossover. The primary outcomes were feasibility and acceptability; clinical outcomes were also assessed. We contacted 888 potential participants. Of the 35% of individuals who were interested in the study, most were ineligible to participate because they lacked transportation to the clinic. Five individuals were eligible and enrolled in the study. All completed 100% of in-clinic sessions. Four participants rated their occupational performance higher after the LSVT BIG intervention. It is feasible to deliver the LSVT BIG in the chronic stroke population. Individuals who complete the protocol demonstrate clinically relevant improvements.",2020,Lee Silverman Voice Treatment-BIG (LSVT BIG) has been used in Parkinson's disease and in two case studies with individuals post-stroke.,"['Five individuals were eligible and enrolled in the study', 'Stroke', 'individuals post-stroke', '888 potential participants']","['Lee Silverman Voice Treatment-BIG Intervention', 'LSVT BIG', 'Lee Silverman Voice Treatment-BIG (LSVT BIG', 'LSVT BIG program']","['feasibility and acceptability; clinical outcomes', 'occupational performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",5.0,0.0565703,Lee Silverman Voice Treatment-BIG (LSVT BIG) has been used in Parkinson's disease and in two case studies with individuals post-stroke.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Proffitt', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Henderson', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Mikayla', 'Initials': 'M', 'LastName': 'Stupps', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Binder', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Irlmeier', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Knapp', 'Affiliation': 'University of Missouri, Columbia, USA.'}]","OTJR : occupation, participation and health",['10.1177/1539449220932908'] 2444,32578685,Pharmacological treatment of female sexual dysfunction: a critical analysis of the placebo and nocebo effects.,,2020,,['female sexual dysfunction'],['placebo'],[],"[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.101458,,"[{'ForeName': 'Lucia Alves da Silva', 'Initials': 'LADS', 'LastName': 'Lara', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}]","Einstein (Sao Paulo, Brazil)",['10.31744/einstein_journal/2020ED5616'] 2445,32578689,How to prevent the malignant progression of bipolar disorder.,"There is increasing recognition that, in a high percentage of cases, bipolar disorder is a progressive illness. Multiple types of sensitization (or increased reactivity to repetition of the same stimulus) drive illness progression. One of the clearest is that of episode sensitization, where increased numbers of prior episodes are associated with: faster recurrences; more dysfunction; disability; social, educational, and employment deficits; suicide; medical comorbidities; cognitive dysfunction; and an increased incidence of dementia in old age. Repetition of stressors and bouts of substance abuse can also result in sensitization. Each type of sensitization appears to have an epigenetic basis, such that preventing sensitization should minimize the accumulation of adverse epigenetic chemical marks on DNA, histones, and microRNA. New data emphasize the importance of early, consistent intervention after an initial manic episode. The cognitive dysfunction associated with a first episode improves only if there are no further episode recurrences during the next year. A randomized study has also shown that comprehensive multimodal prophylactic intervention for 2 years leads to improvements in illness course extending over a total of 6 years. Intensive treatment of the earliest stages of bipolar disorder can thus exert lasting positive effects on the course of illness.",2020,"One of the clearest is that of episode sensitization, where increased numbers of prior episodes are associated with: faster recurrences; more dysfunction; disability; social, educational, and employment deficits; suicide; medical comorbidities; cognitive dysfunction; and an increased incidence of dementia in old age.",[],['comprehensive multimodal prophylactic intervention'],['episode recurrences'],[],"[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0219758,"One of the clearest is that of episode sensitization, where increased numbers of prior episodes are associated with: faster recurrences; more dysfunction; disability; social, educational, and employment deficits; suicide; medical comorbidities; cognitive dysfunction; and an increased incidence of dementia in old age.","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Post', 'Affiliation': 'Bipolar Collaborative Network, School of Medicine, George Washington University, Washington, USA.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2020-0874'] 2446,31272883,A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC).,"BACKGROUND This analysis compared quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST) between nivolumab and everolimus among previously treated patients with advanced renal cell carcinoma enrolled in the phase III CheckMate 025 trial (NCT01668784). MATERIALS AND METHODS At 45-month follow-up, overall survival (OS) was partitioned into 3 health states: TWiST, time with grade ≥ 3 toxicity (TOX), and time after progression (REL). Mean Q-TWiST was determined by multiplying each state's duration with its utility (TWiST, 1.0; TOX, 0.5; REL, 0.5). Relative Q-TWiST gains (calculated as Q-TWiST difference divided by everolimus OS) of ≥ 10% were predefined as clinically important. Immuno-oncology-specific sensitivity analyses considered 4 alternative progression definitions: Tumor size increase ≥ 25% from nadir; treatment discontinuation; ≥ 2-point reduction from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index Disease-Related Symptoms scores; and a composite definition. A scenario incorporating grade ≥ 2 toxicities was tested. RESULTS Compared with everolimus, nivolumab was associated with a significant Q-TWiST improvement of 3.3 months (P < .001). In all sensitivity analyses, nivolumab was associated with Q-TWiST gains (relative gain %) ranging from 3.3 months (14.4%) to 4.8 months (20.9%). CONCLUSIONS Nivolumab is associated with a statistically significant and clinically meaningful gain in quality-adjusted OS versus everolimus among previously treated patients with advanced renal cell carcinoma.",2019,"CONCLUSIONS Nivolumab is associated with a statistically significant and clinically meaningful gain in quality-adjusted OS versus everolimus among previously treated patients with advanced renal cell carcinoma.","['Advanced Renal Cell Carcinoma (aRCC', 'previously treated patients with advanced renal cell carcinoma enrolled in the phase III CheckMate 025 trial (NCT01668784', 'previously treated patients with advanced renal cell carcinoma']","['nivolumab and everolimus', 'Nivolumab Versus Everolimus']","['Relative Q-TWiST gains', 'Q-TWiST gains', 'toxicity (TOX), and time after progression (REL', 'A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST', 'overall survival (OS', 'Mean Q-TWiST']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0035018', 'cui_str': 'rel Oncogene'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0591934,"CONCLUSIONS Nivolumab is associated with a statistically significant and clinically meaningful gain in quality-adjusted OS versus everolimus among previously treated patients with advanced renal cell carcinoma.","[{'ForeName': 'Ruchitbhai', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Pharmerit International, Bethesda, MD.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Botteman', 'Affiliation': 'Pharmerit International, Bethesda, MD. Electronic address: mbotteman@pharmerit.com.'}, {'ForeName': 'Caitlyn T', 'Initials': 'CT', 'LastName': 'Solem', 'Affiliation': 'Pharmerit International, Bethesda, MD.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Pharmerit International, Bethesda, MD.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Doan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.05.010'] 2447,32578718,Subjective time under altered states of consciousness in ayahuasca users in shamanistic rituals involving music.,"Ayahuasca is described as a hallucinogenic substance whose property is to alter the subjective experience of time and impair the perception of the passage of time during stimuli of more than two to three seconds. The dose-dependent effects of two concentrations of ayahuasca in the ritualistic context were investigated employing temporal reproduction tasks in participants experienced in shamanistic ayahuasca rituals. The study was conducted on nine healthy volunteers who ingested two doses of ayahuasca at two times during a ritual session. The doses of each session, consumed in amounts ranging from 20 to 60 mL, were either of low concentration or of experimental ayahuasca according to a double-blind procedure. Participants performed the task of immediately listening and reproducing, with a laptop, 20-s musical stimuli during the session. The results showed that significant temporal distortion was triggered by the musical stimulus presented without the ingestion of ayahuasca, with means of 16.33 to 16.52 s. There were minor temporal distortions after ingestion of ayahuasca: a mean of 17.91 s for control ayahuasca and of 18.38 s for experimental ayahuasca. These results with less temporal distortion among participants with ayahuasca intake disagree with other studies of hallucinogens involving temporal reproduction.",2020,"The results showed that significant temporal distortion was triggered by the musical stimulus presented without the ingestion of ayahuasca, with means of 16.33 to 16.52 s.","['ayahuasca users in shamanistic rituals involving music', 'participants with ayahuasca intake disagree with other studies of hallucinogens involving temporal reproduction', 'nine healthy volunteers who ingested two doses of ayahuasca at two times during a ritual session', 'participants experienced in shamanistic ayahuasca rituals']",['ayahuasca'],['Subjective time under altered states of consciousness'],"[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0233622', 'cui_str': 'Compulsion expressed as ritual'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150450', 'cui_str': 'Altered state of consciousness'}]",9.0,0.0386083,"The results showed that significant temporal distortion was triggered by the musical stimulus presented without the ingestion of ayahuasca, with means of 16.33 to 16.52 s.","[{'ForeName': 'A P S', 'Initials': 'APS', 'LastName': 'Campagnoli', 'Affiliation': 'Departamento de Psicologia, Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brasil.'}, {'ForeName': 'L A S', 'Initials': 'LAS', 'LastName': 'Pereira', 'Affiliation': 'Departamento de Psicologia, Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brasil.'}, {'ForeName': 'J L O', 'Initials': 'JLO', 'LastName': 'Bueno', 'Affiliation': 'Departamento de Psicologia, Faculdade de Filosofia, Ciências e Letras de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brasil.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20209278'] 2448,32578755,Effectiveness of simulation in teaching immunization in nursing: a randomized clinical trial.,"OBJECTIVE to evaluate the effectiveness of the clinical simulation on the cognitive performance of nursing students in adult immunization scenarios in the context of Primary Health Care. METHOD a controlled and randomized pre-test and post-test clinical trial applied to random intervention and control groups. 34 undergraduate nursing students were selected and divided into two groups: classes with active participation of students and skills training (control); and classes with active participation of students, skills training, and clinical simulation (intervention). RESULTS the students in the intervention group performed better than those in the control group in the four assessments of cognitive performance, with statistical significance in the assessments of immediate (p=0.031) and late (1-20 days) (p=0.031) knowledge. CONCLUSION from the simulation, students learn more in the short and medium terms. The information learned is retained for longer and the students are better prepared for the professional practice. Universal Trial Number: u1111-1195-2580.",2020,"the students in the intervention group performed better than those in the control group in the four assessments of cognitive performance, with statistical significance in the assessments of immediate (p=0.031) and late (1-20 days) (p=0.031) knowledge. ","['nursing', '34 undergraduate nursing students', 'nursing students in adult immunization scenarios in the context of Primary Health Care']","['active participation of students and skills training (control); and classes with active participation of students, skills training, and clinical simulation (intervention']",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0408832,"the students in the intervention group performed better than those in the control group in the four assessments of cognitive performance, with statistical significance in the assessments of immediate (p=0.031) and late (1-20 days) (p=0.031) knowledge. ","[{'ForeName': 'Raphael Raniere de Oliveira', 'Initials': 'RRO', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Escola Multicampi de Ciências Médicas do Rio Grande do Norte, Caicó, RN, Brazil.'}, {'ForeName': 'Soraya Maria de', 'Initials': 'SM', 'LastName': 'Medeiros', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Enfermagem, Natal, RN, Brazil.'}, {'ForeName': 'José Carlos Amado', 'Initials': 'JCA', 'LastName': 'Martins', 'Affiliation': 'Escola Superior de Enfermagem de Coimbra, Unidade Científico-Pedagógica de Enfermagem Médico-Cirúrgica, Coimbra, Portugal.'}, {'ForeName': 'Verónica Rita Dias', 'Initials': 'VRD', 'LastName': 'Coutinho', 'Affiliation': 'Escola Superior de Enfermagem de Coimbra, Unidade Científico-Pedagógica de Enfermagem Médico-Cirúrgica, Coimbra, Portugal.'}, {'ForeName': 'Marília Souto de', 'Initials': 'MS', 'LastName': 'Araújo', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Escola Multicampi de Ciências Médicas do Rio Grande do Norte, Caicó, RN, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3147.3305'] 2449,32578775,Cefazolin sodium pentahydrate combined with vacuum sealing drainage in the treatment of open fracture complicated with soft tissue injury.,"OBJECTIVE To investigate the clinical efficacy of cefazolin sodium pentahydrate combined with vacuum sealing drainage (VSD) in the treatment of open fracture complicated with soft tissue injury. METHODS Sixty-three patients with open fracture complicated with soft tissue injury were divided into observation (n = 33) and control (n = 30) groups. After surgical reduction, fixation, and repair of the fractures, the control group was treated with VSD for 10 days, and the observation group was treated with cefazolin sodium pentahydrate based on VSD for 10 days. The infection control time was recorded. After treatment, the pain of patients was evaluated. Before and after treatment, the serum levels of C-reactive protein (CRP), interleukin (IL)-6, IL-8, tumor necrosis factor α (TNF-α), cortisol, epinephrine, norepinephrine, and glucose were detected. After 6 months of treatment, the total effective rate of the treatment was evaluated. RESULTS The infection control time and Visual Analogue Scale score after treatment in the observation group were significantly lower than in the control group, respectively (P < 0.05). After the treatment, the serum levels of CRP, IL-6, IL-8, TNF-α, cortisol, epinephrine, norepinephrine, and glucose in each group were significantly lower than before the treatment (P < 0.05), and each index in observation was significantly lower than in the control group (P < 0.05). CONCLUSIONS In the treatment of open fractures complicated with soft tissue injury, cefazolin sodium pentahydrate combined with VSD can effectively reduce inflammation and stress, thus improving the treatment efficacy.",2020,"The infection control time and Visual Analogue Scale score after treatment in the observation group were significantly lower than in the control group, respectively (P < 0.05).","['Sixty-three patients with open fracture complicated with soft tissue injury were divided into observation (n = 33) and control (n = 30) groups', 'open fracture complicated with soft tissue injury']","['cefazolin sodium pentahydrate combined with VSD', 'Cefazolin sodium pentahydrate combined with vacuum sealing drainage', 'cefazolin sodium pentahydrate combined with vacuum sealing drainage (VSD', 'cefazolin sodium pentahydrate', 'VSD']","['serum levels of C-reactive protein (CRP), interleukin (IL)-6, IL-8, tumor necrosis factor α (TNF-α), cortisol, epinephrine, norepinephrine, and glucose', 'total effective rate', 'index in observation', 'fixation, and repair of the fractures', 'serum levels of CRP, IL-6, IL-8, TNF-α, cortisol, epinephrine, norepinephrine, and glucose', 'infection control time and Visual Analogue Scale score', 'infection control time']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0700526', 'cui_str': 'Cefazolin sodium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",63.0,0.0136703,"The infection control time and Visual Analogue Scale score after treatment in the observation group were significantly lower than in the control group, respectively (P < 0.05).","[{'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zou', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Zhongbin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Che', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.4.430'] 2450,32584155,A novel in-home digital treatment to improve processing speed in people with multiple sclerosis: A pilot study.,"OBJECTIVE To assess whether a videogame-like digital treatment is superior to a control in improving processing speed in adults with multiple sclerosis (MS). METHODS Adults with MS and baseline Symbol Digit Modalities Test (SDMT) z -scores between -2 and 0 were enrolled in a double-blind randomized controlled clinical trial. After completing a baseline in-clinic evaluation (Visit 1), they were randomized to complete an in-home, tablet-based videogame-like digital treatment (AKL-T03) or control word game (AKL-T09) for up to 25 minutes/day, 5 days/week, for 6 weeks. A repeat in-clinic evaluation occurred at 6 weeks (Visit 2), and again 8 weeks later to determine persistence of effects (Visit 3). The pre-specified primary outcome was change in SDMT score between Visits 1 and 2. RESULTS SDMT increased at Visit 2 for participants randomized to both AKL-T03 ( p  < 0.001) and AKL-T09 ( p  = 0.024). These respective mean improvements were +6.10 and +3.55 (comparison p  = 0.21). At Visit 3, 70% of participants randomized to AKL-T03 maintained a clinically meaningful 4+-point increase in SDMT above their baseline, compared with 37% for AKL-T09 ( p  = 0.038). CONCLUSION This in-home digital intervention resulted in substantial and durable improvements in processing speed. A larger randomized controlled clinical trial is planned. TRIAL REGISTRATION This trial is registered on ClinicalTrials.gov under ""NCT03569618,"" https://clinicaltrials.gov/ct2/show/NCT03569618 .",2020,"RESULTS SDMT increased at Visit 2 for participants randomized to both AKL-T03 ( p  < 0.001) and AKL-T09 ( p  = 0.024).","['people with multiple sclerosis', 'Adults with MS and baseline Symbol Digit Modalities Test (SDMT', 'adults with multiple sclerosis (MS']","['videogame-like digital treatment', 'complete an in-home, tablet-based videogame-like digital treatment (AKL-T03) or control word game (AKL-T09']","['SDMT score', 'SDMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}]",,0.338207,"RESULTS SDMT increased at Visit 2 for participants randomized to both AKL-T03 ( p  < 0.001) and AKL-T09 ( p  = 0.024).","[{'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Bove', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rowles', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Langdon', 'Affiliation': 'Royal Holloway, University of London, Egham, UK.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Alexander', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Sacco', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Henry', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada/Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Joaquin A', 'Initials': 'JA', 'LastName': 'Anguera', 'Affiliation': 'Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520930371'] 2451,32584168,"The Effect of ICS Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study: A Randomized, Double-blind Multicenter Trial.","RATIONALE In the IMPACT trial fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. OBJECTIVES Understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results given direct transition from prior maintenance medication to study medication at randomization. METHODS Exacerbations and change from baseline in trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ) were analyzed by prior ICS use. Exacerbations were also analyzed excluding data from the first 30 days. MEASUREMENTS AND MAIN RESULTS FF/UMEC/VI significantly reduced annual moderate/severe exacerbation rate versus UMEC/VI in prior ICS users (29% reduction; p<0.001), but only a numerical reduction was seen among prior ICS non-users (12% reduction; p=0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce annual on-treatment moderate/severe exacerbation rate (19%; p<0.001) versus UMEC/VI. Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001). Improvements from baseline with FF/UMEC/VI versus UMEC/VI were also maintained throughout the study for both trough FEV 1 and SGRQ regardless of prior ICS use. CONCLUSIONS These data support important treatment effects from FF/UMEC/VI combination therapy on exacerbation reduction, lung function and quality of life that do not appear to be related to abrupt ICS withdrawal. FUNDING GSK (CTT116855/NCT02164513). Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02164513.",2020,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).",['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],"['inhaled corticosteroid (ICS', 'FF/UMEC/VI versus UMEC', 'fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI', 'ICS Withdrawal and Baseline Inhaled Treatment']","['severe exacerbation rates', ""trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ"", 'annual moderate/severe exacerbation rate', 'exacerbation reduction, lung function and quality of life', 'severe exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.74081,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, 1259, Pulmonary & Critical Care, Ann Arbor, Michigan, United States; mrking@umich.edu.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University Hospital, 25139, Pulmonary & Critical Care Medicine, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'University of Alabama at Birmingham, 9968, Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, Birmingham, Alabama, United States.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, 171002, College of Medicine and Health, Exeter, Devon, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Development, R&D, Collegeville, Pennsylvania, United States.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Biostatistics, Stockley Park West, Uxbridge, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, 4321, Department of Public Health, Kobenhavn, Denmark.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Biostatistics, Stockley Park West, Uxbridge, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Clinical Sciences, Collegeville, Pennsylvania, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'University College London, 4919, UCL Respiratory, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Global Medical Affairs, Brentford, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, 1500, Division of Pulmonary and Critical Care Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Manchester Academic Health Science Centre, 158986, Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'NewYork-Presbyterian Hospital/Weill Cornell Medical Center, 159947, New York, New York, United States.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2478OC'] 2452,32584285,Photobiomodulation Effect of Low-level Laser Therapy as a Palliative Treatment of Symptomatic Geographic Tongue (A Double-blinded Randomized Clinical Trial).,"AIM To evaluate the effectiveness of photobiomodulation (PBM) of low-level laser therapy (LLLT) as a palliative treatment of symptomatic geographic tongue. MATERIALS AND METHODS This randomized double-blinded controlled clinical trial was performed on 50 patients with symptomatic geographic tongue (GT). Participants were allocated randomly into study and control groups. A 660-nm diode laser was applied on randomly selected patients of the study group ( n = 25) over the complained site for 2 minutes with continuous laser beam application. For the control group ( n = 25), no application of 660-nm diode laser was performed. None of the participants were aware if they received the LLLT or placebo treatment. Patients were assessed for the level of pain, burning sensation, and size of the lesion before starting LLLT ""T0"" and during recall visit ""T1, T2, and T3."" RESULTS The study group showed a low level of pain, burning sensation, and better healing with statistically significant differences at T2 and T3 of the follow-up period, with a level of significance was set at p < 0.05. CONCLUSION Low-level laser therapy can be used to adequately relieve significant discomforts associated with GT and accelerate healing and restoring of the patient's quality of life. CLINICAL SIGNIFICANCE To develop a framework based on the results regarding the photobiomodulation effect of a 660-nm diode laser to relieve pain and burning sensation associated with symptomatic GT, which increases patients' perception toward the services provided to them.",2020,"The study group showed a low level of pain, burning sensation, and better healing with statistically significant differences at T2 and T3 of the follow-up period, with a level of significance was set at p < 0.05. ","['50 patients with symptomatic geographic tongue (GT', 'symptomatic geographic tongue']","['Low-level Laser Therapy', 'LLLT or placebo', '660-nm diode laser', 'photobiomodulation (PBM) of low-level laser therapy (LLLT', 'Low-level laser therapy']","['level of pain, burning sensation, and size of the lesion before starting LLLT ""T0', 'low level of pain, burning sensation, and better healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0017677', 'cui_str': 'Geographic tongue'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",50.0,0.157638,"The study group showed a low level of pain, burning sensation, and better healing with statistically significant differences at T2 and T3 of the follow-up period, with a level of significance was set at p < 0.05. ","[{'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Saad', 'Affiliation': 'Department of Periodontology and Oral Medicine, College of Dentistry, Qassim University, Kingdom of Saudi Arabia, Phone: +966 531017409, e-mail: Dr.islam.saad@qudent.org.'}]",The journal of contemporary dental practice,[] 2453,32584290,Effectiveness of health education in reducing secondhand smoke exposure among pregnant women visiting the antenatal clinic in Saudi Arabia: A randomized controlled trial.,"Background Pregnant women's exposure to secondhand smoking (SHS) is associated with detrimental effects on the pregnancy outcomes. Objectives The objective of the study was to compare the effectiveness of face-to-face counseling, based on health belief model (HBM), combined with a written educational pamphlet, and health education using written pamphlet only, in improving pregnant women's perception, behavior to avoid SHS and change in exposure to SHS. Methods A randomized controlled trial was conducted in 2016. The intervention group received face-to-face health counseling on SHS, while the control group received only written educational pamphlets. Outcomes were the change in the perception of mother on the four constructs of the HBM and the change in mothers' behavior of avoidance of SHS exposure. Results A total of 100 women were recruited for the study, of whom 93 (47 intervention and 46 control) women completed the study. All women identified their spouse as a source of SHS exposure. Following the intervention, the intervention group had significantly higher scores in the perception of susceptibility (21 ± 4 vs. 16 ± 7, P < 0.01) and severity (15 ± 3 vs. 12 ± 4, P < 0.01) and reduced perception scores of barriers to avoid SHS exposure (11 ± 4 vs. 9 ± 5, P = 0.03), compared to the control group. However, there was an insignificant change in the exposure to SHS after the intervention in both the groups; where 25 (53.2%) women in the intervention group and 31 (67.4%) in the control group (P = 0.16), continued to being exposed to SHS. Conclusion Counselling of pregnant women, based on HBM, has insignificant effect in reducing their exposure to SHS; however it is effective in improving their knowledge and perception about SHS exposure.",2020,"Following the intervention, the intervention group had significantly higher scores in the perception of susceptibility (21 ± 4 vs. 16 ± 7, P < 0.01) and severity (15 ± 3 vs. 12 ± 4, P < 0.01) and reduced perception scores of barriers to avoid SHS exposure (11 ± 4 vs. 9 ± 5, P = 0.03), compared to the control group.","['pregnant women', 'pregnant women visiting the antenatal clinic in Saudi Arabia', 'A total of 100 women were recruited for the study, of whom 93 (47 intervention and 46 control', ""\n\n\nPregnant women's exposure to secondhand smoking (SHS""]","['face-to-face counseling, based on health belief model (HBM), combined with a written educational pamphlet, and health education using written pamphlet', 'health education', 'face-to-face health counseling on SHS, while the control group received only written educational pamphlets']","['perception of susceptibility', 'reduced perception scores of barriers to avoid SHS exposure', 'secondhand smoke exposure']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",100.0,0.0393662,"Following the intervention, the intervention group had significantly higher scores in the perception of susceptibility (21 ± 4 vs. 16 ± 7, P < 0.01) and severity (15 ± 3 vs. 12 ± 4, P < 0.01) and reduced perception scores of barriers to avoid SHS exposure (11 ± 4 vs. 9 ± 5, P = 0.03), compared to the control group.","[{'ForeName': 'Hayfaa A', 'Initials': 'HA', 'LastName': 'Wahabi', 'Affiliation': 'Chair of Evidence Based Health Care and Knowledge Translation, College of Medicine; Department of Community and Family Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Massis', 'Affiliation': 'Department of Community and Family Medicine, King Saud University, Riyadh, Saudi, Arabia.'}, {'ForeName': 'Amel A', 'Initials': 'AA', 'LastName': 'Fayed', 'Affiliation': 'Department of Clinical, Princess Nourah Bint Abdulrahman University, College of Medicine, Riyadh, Saudi Arabia; Department of Biostatistics, Alexandria University, High Institute of Public Health, Alexandria, Egypt.'}, {'ForeName': 'Samia A', 'Initials': 'SA', 'LastName': 'Esmaeil', 'Affiliation': 'Chair of Evidence Based Health Care and Knowledge Translation, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}]",Indian journal of public health,['10.4103/ijph.IJPH_63_19'] 2454,32578433,The Impact of Multiple Renal Estimates on Pharmacist Dosing Recommendations: A Randomized Trial.,"Background: Numerous equations are used for estimation of renal function, and many electronic medical records report multiple clearance estimates to assist with drug dosing. It is unknown whether the presence of multiple clearance estimates affects clinical decision-making. Objective: To determine whether the presence of multiple renal clearance estimates affects pharmacist drug dosing decisions. Methods : A randomized trial in the form of an electronic survey including 4 clinical vignettes was delivered to hospital pharmacists. Vignettes consisted of a patient presenting with an acute pulmonary embolism requiring enoxaparin therapy. Pharmacists were randomized to receive a single estimate of renal function or multiple estimates for all vignettes. The primary outcome was deviation from approved recommendations on at least 1 vignette. The χ 2 test was used to detect differences in deviation rates between groups. Logistic regression was performed to adjust for the effects of potentially confounding variables. Results: A total of 154 studies were completed (73 in the multiple-estimate group and 81 in the single-estimate group). Pharmacists presented with multiple renal estimates were significantly more likely to deviate from recommended dosing regimens than pharmacists presented with a single estimate (54.7% vs 38.2%; P = 0.04). The results were driven primarily by the 2 vignettes that included discordance among Cockcroft-Gault equation creatinine clearance estimates. Logistic regression identified multiple estimates as the only independent predictor of deviation ( P = 0.04). Conclusion and Relevance: Pharmacists provided with a single renal clearance estimate were more likely to adhere to approved dosing recommendations than pharmacists provided with multiple estimates.",2020,Pharmacists presented with multiple renal estimates were significantly more likely to deviate from recommended dosing regimens than pharmacists presented with a single estimate (54.7% vs 38.2%; P = 0.04).,['A total of 154 studies were completed (73 in the multiple-estimate group and 81 in the single-estimate group'],['enoxaparin therapy'],"['deviation rates', 'deviation from approved recommendations on at least 1 vignette', 'multiple renal estimates']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",154.0,0.0683156,Pharmacists presented with multiple renal estimates were significantly more likely to deviate from recommended dosing regimens than pharmacists presented with a single estimate (54.7% vs 38.2%; P = 0.04).,"[{'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'McConachie', 'Affiliation': 'Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Hanni', 'Affiliation': 'Beaumont Hospital, Royal Oak, MI, USA.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Raub', 'Affiliation': 'Detroit Receiving Hospital, MI, USA.'}, {'ForeName': 'Rima A', 'Initials': 'RA', 'LastName': 'Mohammad', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Wilhelm', 'Affiliation': 'Wayne State University, Detroit, MI, USA.'}]",The Annals of pharmacotherapy,['10.1177/1060028020935447'] 2455,32578466,Additional Low-Voltage-Area Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the Randomized Controlled VOLCANO Trial.,"Background The efficacy of low-voltage-area (LVA) ablation has not been well determined. This study aimed to investigate the efficacy of LVA ablation in addition to pulmonary vein isolation on rhythm outcomes in patients with paroxysmal atrial fibrillation (AF). Methods and Results VOLCANO (Catheter Ablation Targeting Low-Voltage Areas After Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation Patients) trial included paroxysmal AF patients undergoing initial AF ablation. Of 398 patients in whom a left atrial voltage map was obtained after pulmonary vein isolation, 336 (85%) had no LVA (group A). The remaining 62 (15%) patients with LVAs were randomly allocated to undergo LVA ablation (group B, n=30) or not (group C, n=32) in a 1:1 fashion. Primary end point was 1-year AF-recurrence-free survival rate. No adverse events related to LVA ablation occurred. Procedural (124±40 versus 95±33 minutes, P =0.003) and fluoroscopic times (29±11 versus 24±8 minutes, P =0.034) were longer in group B than group C. Patients with LVAs demonstrated lower AF-recurrence-free survival rates (88%) than those without LVA (B, 57%, P <0.0001; C, 53%, P <0.0001). However, LVA ablation in addition to pulmonary vein isolation did not impact AF-recurrence-free survival rate (group B versus C, P =0.67). Conclusions The presence of LVA was a strong predictor of AF recurrence after pulmonary vein isolation in patients with paroxysmal AF. However, LVA ablation had no beneficial impact on 1-year rhythm outcomes. Registration URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000023403.",2020,"Procedural (124±40 versus 95±33 minutes, P =0.003) and fluoroscopic times (29±11 versus 24±8 minutes, P =0.034) were longer in group B than group C. Patients with LVAs demonstrated lower AF-recurrence-free survival rates (88%) than those without LVA (B, 57%, P <0.0001; C, 53%, P <0.0001).","['Patients With Paroxysmal Atrial Fibrillation', 'The remaining 62 (15%) patients with LVAs', 'Paroxysmal Atrial Fibrillation Patients) trial included paroxysmal AF patients undergoing initial AF ablation', 'patients with paroxysmal atrial fibrillation (AF', '398 patients in whom a left atrial voltage map was obtained after pulmonary vein isolation, 336 (85%) had no LVA (group A', 'patients with paroxysmal AF']","['Catheter Ablation Targeting Low-Voltage Areas', 'Additional Low-Voltage-Area Ablation', 'low-voltage-area (LVA) ablation', 'pulmonary vein isolation', 'LVA ablation']","['1-year AF-recurrence-free survival rate', 'impact AF-recurrence-free survival rate', '1-year rhythm outcomes', 'fluoroscopic times', 'lower AF-recurrence-free survival rates', 'AF recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0452221,"Procedural (124±40 versus 95±33 minutes, P =0.003) and fluoroscopic times (29±11 versus 24±8 minutes, P =0.034) were longer in group B than group C. Patients with LVAs demonstrated lower AF-recurrence-free survival rates (88%) than those without LVA (B, 57%, P <0.0001; C, 53%, P <0.0001).","[{'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Mitsutoshi', 'Initials': 'M', 'LastName': 'Asai', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ishihara', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Nanto', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsujimura', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Okuno', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Hata', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Mano', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015927'] 2456,32129511,Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials.,"Romiplostim self-administration by patients or caregivers may offer time/cost savings to healthcare professionals (HCPs) and convenience for patients who avoid weekly clinic visits. We performed an integrated analysis of five clinical trials to evaluate the efficacy and safety of romiplostim self-administration. Data were analyzed from adults with immune thrombocytopenia (ITP) who received weekly romiplostim via self-administration or from an HCP. Patients who achieved a stable romiplostim dose for ≥3 weeks (HCP group ≥5 weeks to provide an appropriate index date to enable comparisons with the self-administration group) with platelet counts ≥50 × 10 9 /L were eligible. In the self-administration (n = 621) vs HCP (n = 133) groups, respectively, median age was 53 vs 58 years, median time since primary ITP diagnosis was 3.7 vs 2.5 years, and median baseline platelet count at ITP diagnosis was 19.0 vs 20.0 × 10 9 /L. In the self-administration and HCP-dosed groups, median romiplostim treatment duration was 89 vs 52 weeks and median total number of doses was 81 vs 50, respectively. In the self-administration and HCP groups, respectively: 95.0% and 100.0% of patients achieved ≥1 platelet response (defined as weekly platelet count ≥50 × 10 9 /L without rescue medication in previous 4 weeks); the median percentage of weeks with a response was 94.5% and 95.9%; and rescue medication was used in 36.7% and 39.8% of patients. Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration. Romiplostim self-administration appears effective and well tolerated in eligible patients with ITP.",2020,Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration.,"['eligible patients with ITP', 'Patients who achieved a stable romiplostim dose for ≥3\u2009weeks', 'patients who avoid weekly clinic visits', 'patients with immune thrombocytopenia', '10 9 /L were eligible', 'adults with immune thrombocytopenia (ITP) who received weekly']","['self-administered romiplostim', 'romiplostim self-administration', 'romiplostim via self-administration or from an HCP']","['platelet response', 'median time since primary ITP diagnosis', 'Safety and efficacy', 'rescue medication', 'median romiplostim treatment duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0162531', 'cui_str': 'Hereditary coproporphyria'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",621.0,0.0679414,Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration.,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kuter', 'Affiliation': 'Hematology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Arnold', 'Affiliation': 'Canadian Blood Services and Department of Medicine, McMaster Centre for Transfusion Research, Michael G DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Rodeghiero', 'Affiliation': 'Haematology Project Foundation, Affiliated to the Department of Haematology, S. Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Department of Hematology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Selleslag', 'Affiliation': 'Department of Hematology, AZ Sint Jan Brugge, Bruges, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bird', 'Affiliation': 'Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Newland', 'Affiliation': 'The Pathology Clinical Academic Group, The Royal London Hospital, London, UK.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'Department of Internal Medicine, Haematology and Oncology, Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Kejia', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Olie', 'Affiliation': 'Amgen (Europe) GmbH, Rotkreuz, Switzerland.'}]",American journal of hematology,['10.1002/ajh.25776'] 2457,30224150,Effectiveness and cost-effectiveness of early nutritional support via the parenteral versus the enteral route for critically ill adult patients.,,2019,,['critically ill adult patients'],['early nutritional support via the parenteral versus the enteral route'],['Effectiveness and cost-effectiveness'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0183415,,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sadique', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom. Electronic address: Zia.Sadique@lshtm.ac.uk.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Bear', 'Affiliation': ""Department of Nutrition and Dietetics, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2018.08.025'] 2458,30882595,Fish and omega-3 fatty acid consumption and risk of hypertension.,"BACKGROUND Experimental studies suggest that omega-3 fatty acid have favorable effects on blood pressure (BP). However, data on the association of long-term dietary intake of omega-3 fatty acid or fish with risk of hypertension in healthy subjects are sparse. We examined whether fish or omega-3 fatty acid consumption was associated with incident hypertension in the Physicians' Health Study (PHS). METHODS In a prospective cohort study, we analyzed data on 12 279 PHS participants (mean age: 53.0 ± 8.7 years) free of hypertension at baseline. Fish and omega-3 fatty acid consumption were assessed from a baseline semiquantitative food-frequency questionnaire. Incident hypertension was ascertained via self-reports on annual follow-up questionnaires. RESULTS During a mean follow-up of 15.8 years, 6299 men (51.3%) developed hypertension. In a multivariable model controlling for established risk factors for hypertension, fish and omega-3 fatty acid consumption was not significantly associated with incident hypertension. The hazard ratio (95% CI) of hypertension was 1.10 (0.93-1.30) for men who consumed at least five servings per week of fish compared with those who did not consume any fish (P for trend = 0.29). For the highest versus lowest quintile of omega-3 fatty acid intake, the hazard ratio of hypertension was 1.02 (0.94-1.11) (P for trend = 0.34). The associations did not vary by type of fish. There was also no evidence of effect modification by baseline BP, BMI, or history of hypercholesterolemia. CONCLUSION Overall, long-term dietary intake of fish and omega-3 fatty acid was not associated with incident hypertension in a cohort of middle-aged and older US men.",2019,"In a multivariable model controlling for established risk factors for hypertension, fish and omega-3 fatty acid consumption was not significantly associated with incident hypertension.","['12\u200a279 PHS participants (mean age: 53.0\u200a±\u200a8.7 years) free of hypertension at baseline', 'middle-aged and older US men', 'healthy subjects']","['Fish and omega-3 fatty acid consumption', 'fish or omega-3 fatty acid consumption', 'omega-3 fatty acid', 'fish and omega-3 fatty acid']","['incident hypertension', 'hazard ratio of hypertension', 'baseline BP, BMI, or history of hypercholesterolemia', 'hazard ratio', 'blood pressure (BP', 'Incident hypertension', 'hypertension']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1533076', 'cui_str': 'History of hypercholesterolemia'}]",12279.0,0.0550152,"In a multivariable model controlling for established risk factors for hypertension, fish and omega-3 fatty acid consumption was not significantly associated with incident hypertension.","[{'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': ""Division of Aging, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Yoruk', 'Affiliation': 'Department of Cardiology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital.""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': ""Division of Aging, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Aging, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",Journal of hypertension,['10.1097/HJH.0000000000002062'] 2459,30883913,"Associations Among Hair Cortisol Concentrations, Posttraumatic Stress Disorder Status, and Amygdala Reactivity to Negative Affective Stimuli in Female Police Officers.","Posttraumatic stress disorder (PTSD) is associated with altered hypothalamic-pituitary-adrenal (HPA) axis function. Measurement of hair cortisol concentrations (HCC) allows retrospective assessment of HPA axis regulation over prolonged periods of time. Currently, research investigating HCC in PTSD remains sparse. Previous cross-sectional studies have included only civilian populations, although it is known that trauma type moderates associations between PTSD status and HPA axis function. We investigated differences in HCC between trauma-exposed female police officers with current PTSD (n = 13) and without current and lifetime PTSD (n = 15). To investigate whether HCC was associated with neural correlates of PTSD, we additionally performed exploratory correlational analyses between HCC and amygdala reactivity to negative affective stimuli. We observed significantly lower HCC in participants with PTSD than in participants without PTSD, d = 0.89. Additionally, within participants with PTSD, we observed positive correlations between HCC and right amygdala reactivity to negative affective (vs. happy/neutral) faces, r = .806 (n = 11) and left amygdala reactivity to negative affective (vs. neutral) pictures, r = .663 (n = 10). Additionally, left amygdala reactivity to negative faces was positively correlated with HCC in trauma-exposed controls, r = .582 (n = 13). This indicates that lower HCC is associated with diminished amygdala differentiation between negative affective and neutral stimuli. Thus, we observed lower HCC in trauma-exposed noncivilian women with PTSD compared to those without PTSD, which likely reflects prolonged HPA axis dysregulation. Additionally, HCC was associated with hallmark neurobiological correlates of PTSD, providing additional insights into pathophysiological processes in PTSD.",2019,"We observed significantly lower HCC in participants with PTSD than in participants without PTSD, d = 0.89.","['HCC between trauma-exposed female police officers with current PTSD (n = 13) and without current and lifetime PTSD (n = 15', 'Posttraumatic stress disorder (PTSD']",['HCC'],"['Hair Cortisol Concentrations, Posttraumatic Stress Disorder Status, and Amygdala Reactivity', 'hair cortisol concentrations (HCC']","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086825', 'cui_str': 'Policeman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",15.0,0.00942021,"We observed significantly lower HCC in participants with PTSD than in participants without PTSD, d = 0.89.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'van Zuiden', 'Affiliation': 'Department of Psychiatry Amsterdam University Medical Centers-Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Savas', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Saskia B J', 'Initials': 'SBJ', 'LastName': 'Koch', 'Affiliation': 'Department of Psychiatry Amsterdam University Medical Centers-Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nawijn', 'Affiliation': 'Department of Psychiatry Amsterdam University Medical Centers-Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Sabine M', 'Initials': 'SM', 'LastName': 'Staufenbiel', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Jessie L', 'Initials': 'JL', 'LastName': 'Frijling', 'Affiliation': 'Department of Psychiatry Amsterdam University Medical Centers-Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Dick J', 'Initials': 'DJ', 'LastName': 'Veltman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers-VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Elisabeth F C', 'Initials': 'EFC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Olff', 'Affiliation': 'Department of Psychiatry Amsterdam University Medical Centers-Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}]",Journal of traumatic stress,['10.1002/jts.22395'] 2460,30913347,The Association Between Negative Trauma-Related Cognitions and Pain-Related Functional Status Among Veterans With Posttraumatic Stress Disorder and Alcohol Use Disorder.,"Among veterans with posttraumatic stress disorder (PTSD), alcohol use disorders (AUDs) are highly prevalent. Furthermore, PTSD frequently co-occurs with chronic pain (CP), and CP is associated with an increased risk of AUD. Pain-related beliefs and appraisals are significantly associated with poorer pain-related functional status, yet few studies have examined negative trauma-related cognitions and their impact on pain-related functional disability in veterans with co-occurring PTSD and AUD. Accordingly, we examined the association between negative trauma-related cognitions and pain severity and pain disability in 137 veterans seeking treatment for PTSD and AUD. Using hierarchical multiple linear regression, we found that higher levels of negative trauma-related cognitions (e.g., ""I am completely incompetent"") were associated with a higher level of pain severity, after controlling for PTSD symptom severity and frequency of alcohol use, total R 2 = .07, ΔR 2 = .06. Additionally, as hypothesized, we found that higher levels of negative trauma-related cognitions were associated with higher levels of pain disability, after controlling for PTSD symptom severity, frequency of alcohol use, and pain severity, total R 2 = .46, ΔR 2 = .03. Given that negative trauma-related cognitions contributed to pain severity and pain disability, even when controlling for PTSD severity and frequency of alcohol use, future studies should explore the potential impact of interventions that address negative trauma-related cognitions (e.g., prolonged exposure or cognitive processing therapy) on pain severity and disability.",2019,"Using hierarchical multiple linear regression, we found that higher levels of negative trauma-related cognitions (e.g., ""I am completely incompetent"") were associated with a higher level of pain severity, after controlling for PTSD symptom severity and frequency of alcohol use, total R 2 = .07, ΔR 2 = .06.","['veterans with posttraumatic stress disorder (PTSD', '137 veterans seeking treatment for PTSD and AUD', 'Veterans With Posttraumatic Stress Disorder and Alcohol Use Disorder', 'veterans with co-occurring PTSD and AUD']",[],"['pain disability', 'PTSD symptom severity, frequency of alcohol use, and pain severity', 'pain severity and disability', 'pain severity and pain disability', 'higher levels of negative trauma-related cognitions', 'negative trauma-related cognitions and pain severity and pain disability', 'level of pain severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0107999,"Using hierarchical multiple linear regression, we found that higher levels of negative trauma-related cognitions (e.g., ""I am completely incompetent"") were associated with a higher level of pain severity, after controlling for PTSD symptom severity and frequency of alcohol use, total R 2 = .07, ΔR 2 = .06.","[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Curry', 'Affiliation': 'VA San Diego Healthcare System, La Jolla, California, USA.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Malaktaris', 'Affiliation': 'VA San Diego Healthcare System, La Jolla, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lyons', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Herbert', 'Affiliation': 'VA San Diego Healthcare System, La Jolla, California, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, La Jolla, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22394'] 2461,32578960,"""Individual Placement and Support"" boosts employment for early psychosis clients, even when baseline rates are high.","AIM Individual Placement and Support is an effective vocational intervention for increasing competitive employment for people with severe mental illness. Little is known, however, about its effectiveness in the context of early psychosis. This study assesses improvements in clients' employment in a phase of illness during which functional abilities often decline. METHODS The trial design is an assessor-blinded randomized clinical trial, set in the context of a population-based Early Psychosis Intervention program in British Columbia, Canada. Participants were randomized either to 1 year of employment support added to treatment-as-usual, or the latter alone. Interviews at intake captured data regarding demographics, symptom severity, and employment; assessments at 6 and 12 months repeated queries about employment activities. RESULTS A total of 109 clients were recruited. Employment rates in the Individual Placement and Support group increased over time, unlike the control group. Further, the number of days worked over the 12-month intervention period, compared to the 6 months prior to the study, improved for both groups, but the increase was greater among clients receiving IPS. Sensitivity analysis indicated the advantage in days worked was evident in the second half of the intervention period (6-12 months), but not the first half. CONCLUSIONS Employment rates, for younger clients in both early-psychosis groups, were high compared to older clients in later stages of illness. In this study, use of the Individual Placement and Support strategy further increased employment, despite the high baseline rates. Further research is needed to identify the optimal timing of employment support for these clients.",2020,"CONCLUSIONS Employment rates, for younger clients in both early-psychosis groups, were high compared to older clients in later stages of illness.","['early psychosis clients', 'A total of 109 clients were recruited', 'people with severe mental illness', 'context of a population-based Early Psychosis Intervention program in British Columbia, Canada']","['Individual Placement and Support"" boosts employment', 'employment support added to treatment-as-usual, or the latter alone']",['Employment rates'],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}]",109.0,0.0471969,"CONCLUSIONS Employment rates, for younger clients in both early-psychosis groups, were high compared to older clients in later stages of illness.","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Erickson', 'Affiliation': 'Fraser Health Early Psychosis Intervention Program, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Meighen M', 'Initials': 'MM', 'LastName': 'Roes', 'Affiliation': 'Fraser Health Early Psychosis Intervention Program, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'DiGiacomo', 'Affiliation': 'Fraser Health Early Psychosis Intervention Program, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Fraser Health Early Psychosis Intervention Program, New Westminster, British Columbia, Canada.'}]",Early intervention in psychiatry,['10.1111/eip.13005'] 2462,32579051,"The time course of passive stiffness responses following an acute bout of static stretching in healthy, elderly men.","BACKGROUND The time course of passive stiffness responses following an acute bout of static stretching has received little research attention, particularly in older adults. OBJECTIVE To determine the time course of the acute effects of static stretching on passive stiffness of the hamstrings in healthy, elderly men. METHODS Fifteen elderly men (age = 70 ± 7 years) underwent two randomized conditions that included a control treatment and an experimental treatment of four, 15-s straight-leg raise static stretches. Passive stiffness was calculated as the slopes of the initial and final phases of the angle-torque curve at pre-treatment (Pre) and post-treatment time points of zero (Post0), five (Post5), and ten (Post10) minutes. RESULTS Passive stiffness collapsed across phase was lower at Post0 ( P = .029, d = 0.64) and Post5 ( P = .042, d = 0.54) but not Post10 ( P > .999, d = 0.15) compared to Pre for the stretching treatment. There were no significant differences in passive stiffness (collapsed across phase) between any of the time points ( P > .999, d ≤ 0.14) for the control. CONCLUSIONS An acute bout of static stretching produced significant decreases in the passive stiffness characteristics of elderly men; however, these decreases returned to baseline values within 5 to 10 minutes.",2020,"RESULTS Passive stiffness collapsed across phase was lower at Post0 ( P = .029, d = 0.64) and Post5 ( P = .042, d = 0.54) but not Post10 ( P > .999, d = 0.15) compared to Pre for the stretching treatment.","['elderly men', 'Fifteen elderly men (age\xa0=\xa070\xa0±\xa07\xa0years', 'older adults', 'healthy, elderly men']",['static stretching'],"['Passive stiffness', 'passive stiffness']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0427008', 'cui_str': 'Stiffness'}]",15.0,0.0204849,"RESULTS Passive stiffness collapsed across phase was lower at Post0 ( P = .029, d = 0.64) and Post5 ( P = .042, d = 0.54) but not Post10 ( P > .999, d = 0.15) compared to Pre for the stretching treatment.","[{'ForeName': 'Ty B', 'Initials': 'TB', 'LastName': 'Palmer', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University , Lubbock, TX, USA.'}, {'ForeName': 'Ahalee C', 'Initials': 'AC', 'LastName': 'Farrow', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University , Lubbock, TX, USA.'}, {'ForeName': 'Chinonye C', 'Initials': 'CC', 'LastName': 'Agu-Udemba', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University , Lubbock, TX, USA.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Mitchell', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University , Lubbock, TX, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1783729'] 2463,32579078,Observations on changes in ventricular repolarization following four weeks of exercise training in chronic heart failure patients.,"Objective: The aim of this study was to investigate the effects of exercise training on ventricular repolarization dynamicity and heart rate variability in chronic heart failure patients. Design: A total of 22 chronic heart failure patients with reduced ejection fraction in sinus rhythm were included in the study. The patients were in NYHA classes II-III with an ejection fraction of 29.7 ± 7.7%. Before and after 4 weeks of aerobic exercise training, all patients performed a cardiopulmonary exercise test, a standard twelve-lead electrocardiogram and a 24 h Holter recording from which heart rate variability and ventricular repolarization dynamicity were assessed. Results: We observed a significant decrease of QTpeak ( p  < .001) and QTend ( p  < .001) at RR intervals ranging from 600 to 1000 ms on 24 h QT/RR regressions after 4 weeks of exercise training. Our analyses revealed that short-term exercise training induced significant changes in the frequency and time domain HRV parameters on an overall time-period of 24 h. Conclusion: Four weeks of exercise training induced significant changes in ventricular repolarization dynamicity in chronic heart failure patients. In addition, short-term exercise training was enough to improve patients' heart rate variability.",2020,We observed a significant decrease of QTpeak ( p  < .001) and QTend ( p  < .001) at RR intervals ranging from 600 to 1000 ms on 24 h QT/RR regressions after 4 weeks of exercise training.,"['chronic heart failure patients', '22 chronic heart failure patients with reduced ejection fraction in sinus rhythm']","['exercise training', 'short-term exercise training', 'aerobic exercise training']","['ventricular repolarization', 'ventricular repolarization dynamicity and heart rate variability', 'frequency and time domain HRV parameters', 'ventricular repolarization dynamicity', 'QTpeak']","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",22.0,0.0155513,We observed a significant decrease of QTpeak ( p  < .001) and QTend ( p  < .001) at RR intervals ranging from 600 to 1000 ms on 24 h QT/RR regressions after 4 weeks of exercise training.,"[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Caru', 'Affiliation': 'Laboratory of Pathophysiology of EXercise (LPEX), School of Kinesiology and Physical Activity Sciences, Faculty of Medicine, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gravel', 'Affiliation': 'Laboratory of Pathophysiology of EXercise (LPEX), School of Kinesiology and Physical Activity Sciences, Faculty of Medicine, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'INSERM U586, Laboratory of Medical and Clinical Pharmacology, Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bousquet', 'Affiliation': 'Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Galinier', 'Affiliation': 'INSERM U586, Laboratory of Medical and Clinical Pharmacology, Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Jacquemet', 'Affiliation': 'Department of Pharmacology and Physiology, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Curnier', 'Affiliation': 'Laboratory of Pathophysiology of EXercise (LPEX), School of Kinesiology and Physical Activity Sciences, Faculty of Medicine, University of Montreal, Montreal, Canada.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2020.1783458'] 2464,32579105,"Management of unstable pertrochanteric fractures, evaluation of forgotten treatment options.","INTRODUCTION Unstable trochanteric fractures are challenging with a high rate of implant failure and re-operation. Cephalomedullary nails proved to be a rational management choice for these injuries, yet other management options have not been well assessed. The aim of this study was to compare the use of DHS with trochanteric stabilizing plate (TSP) and proximal femoral locked plate (PFLP) in unstable pertrochanteric fractures. METHODS This randomized controlled trial (RCT) included 40 patients (22 males, 18 females) with unstable pertrochanteric fractures (AO/OTA 31A2.2/A2.3). The patients were randomized into group 1 managed by DHS with TSP while group 2 was managed by PFLP. All patients were followed up for 1 year. Patients were assessed radiographically and clinically using Harris hip score (HHS) at 3, 6 and 12 months. Operative time, estimated blood loss and time to union were also compared. RESULTS The difference of intra-operative variables, including operative time and intra-operative blood loss, between both groups was statistically insignificant. Time to bony union was faster in the first group with a statistically significant P value (p = 0.04). Functional outcome per HHS was significantly better in group 1 (p < 0.01) and implant failure in group 1 occurred statistically lesser (p < 0.01). DISCUSSION DHS with TSP appears to be a good option of management for unstable pertrochanteric fractures. In contrast, the use of PFLP in unstable pertrochanteric fractures in the elderly does not appear to be a good alternative.",2020,Time to bony union was faster in the first group with a statistically significant P value (p = 0.04).,"['unstable pertrochanteric fractures', '40 patients (22 males, 18 females) with unstable pertrochanteric fractures (AO/OTA 31A2.2/A2.3']","['DHS with trochanteric stabilizing plate (TSP) and proximal femoral locked plate (PFLP', 'PFLP', 'TSP', 'DHS with TSP']","['Operative time, estimated blood loss and time to union', 'implant failure', 'Functional outcome per HHS', 'operative time and intra-operative blood loss', 'Time to bony union']","[{'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0281883', 'cui_str': 'Pertrochanteric fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}]","[{'cui': 'C0082226', 'cui_str': 'eIF-5A-deoxyhypusine synthase'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0391889', 'cui_str': 'Synostosis'}]",40.0,0.027619,Time to bony union was faster in the first group with a statistically significant P value (p = 0.04).,"[{'ForeName': 'Amr Ahmed Hosny Abdo', 'Initials': 'AAHA', 'LastName': 'Selim', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Fady Kamal', 'Initials': 'FK', 'LastName': 'Beder', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim Taha', 'Initials': 'IT', 'LastName': 'Algeaidy', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Samir', 'Initials': 'AS', 'LastName': 'Farhat', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nader M', 'Initials': 'NM', 'LastName': 'Diab', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Samir', 'Initials': 'AS', 'LastName': 'Barakat', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",SICOT-J,['10.1051/sicotj/2020020'] 2465,32579120,Elderly Medication Adherence Intervention Using the My Interventional Drug-Eluting Stent Educational App: Multisite Randomized Feasibility Trial.,"BACKGROUND A lifesaving treatment for myocardial infarction is the placement of a stent in a closed or obstructed coronary artery. The largest modifiable risk factor after receiving a stent is medication adherence to Dual AntiPlatelet Therapy, a combination of P2Y12 inhibitors and aspirin. OBJECTIVE This study aimed to determine the acceptability of a protocol and an intervention using the My Interventional Drug-Eluting Stent Educational App (MyIDEA) and to evaluate medication adherence using the proportion of days covered (PDC) and platelet activation tests in a multisite randomized controlled trial. METHODS Potential participants who received a post percutaneous coronary intervention (PCI) procedure with a drug-eluting stent were approached. All patients older than 50 years and who spoke English were recruited. Participants were recruited, baseline demographics were collected, and the Hospital Anxiety and Depression Scale (HADS), Rapid Estimate of Adult Literacy in Medicine-Short Form, Burden-Benefit questionnaire, 36-Item Short Form Health Survey, and PCI knowledge questionnaire were administered. Block randomization was used to randomize participants to either usual care or MyIDEA supplementation. MyIDEA is a personalized educational intervention based on the Kolb experiential learning theory using patient narratives for education. During the visits, participants' blood was collected to measure platelet suppression from medication. During the second and third encounters, the Morisky medication adherence score and cardiology outcomes were measured. The study was conducted at the University of Illinois Hospital and John H Stroger Jr Cook County Hospital with appropriate ethical approvals. Platelet suppression was measured through aspirin reactive units and P2Y12 reactive units. Medication adherence was measured using the PDC. The analysis team was blinded to the participants' group membership. The primary outcome was a feasibility analysis of recruitment and retention. RESULTS The mean age of participants was 60.4 years (SD 7.1); the majority of patients were black and non-Hispanic. The majority of patients' reading levels were seventh grade or above, and they were not very familiar with other electronic devices for information and communication. The number of control subjects was 21, and the number of participants in the interventional arm was 24. The interventional group was able to use MyIDEA in both the hospital and outpatient setting. However, there was no significant difference in platelet suppression or medication adherence between groups. There were also differences between the groups in terms of depression and anxiety, initially, as measured by HADS. No documented adverse event associated with the intervention was found. CONCLUSIONS Elderly patients are willing to use tablet devices to be educated about health conditions. Additional studies are required to measure the effectiveness and determine the most suitable timing and location for patient education. TRIAL REGISTRATION ClinicalTrials.gov NCT04439864; https://clinicaltrials.gov/ct2/show/NCT04439864.",2020,"However, there was no significant difference in platelet suppression or medication adherence between groups.","['The mean age of participants was 60.4 years (SD 7.1); the majority of patients were black and non-Hispanic', 'University of Illinois Hospital and John H Stroger Jr Cook County Hospital with appropriate ethical approvals', 'Potential participants who received a post percutaneous coronary intervention (PCI) procedure with a drug-eluting stent were approached', 'Elderly patients', 'All patients older than 50 years and who spoke English were recruited']","['usual care or MyIDEA supplementation', 'My Interventional Drug-Eluting Stent Educational App (MyIDEA', 'P2Y12 inhibitors and aspirin']","['Medication adherence', 'Platelet suppression', 'feasibility analysis of recruitment and retention', 'Morisky medication adherence score and cardiology outcomes', 'platelet suppression or medication adherence', 'Burden-Benefit questionnaire, 36-Item Short Form Health Survey, and PCI knowledge questionnaire', 'Hospital Anxiety and Depression Scale (HADS', 'depression and anxiety']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0020005', 'cui_str': 'County Hospitals'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.112566,"However, there was no significant difference in platelet suppression or medication adherence between groups.","[{'ForeName': 'Andrew Dallas', 'Initials': 'AD', 'LastName': 'Boyd', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Chioma Iheanyi', 'Initials': 'CI', 'LastName': 'Ndukwe', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Anandu', 'Initials': 'A', 'LastName': 'Dileep', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Olivia Frances', 'Initials': 'OF', 'LastName': 'Everin', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Welland', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Field', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Baumann', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Flores', 'Affiliation': 'Patient Advisor, Department of Biomedical and Health Information Sciences, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Adhir', 'Initials': 'A', 'LastName': 'Shroff', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Groo', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Dickens', 'Affiliation': 'Department of Biomedical and Health Information Science, University of Illinois at Chicago, Chicago, United States.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Doukky', 'Affiliation': 'Divison of Cardiology, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Regeena', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'Divison of Cardiology, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Peacock', 'Affiliation': 'Divison of Cardiology, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL, United States.'}]",JMIR mHealth and uHealth,['10.2196/15900'] 2466,32574009,"A Double-Blind, Comparative Clinical Study of Newly Formulated Retinol Serums vs Tretinoin Cream in Escalating Doses: A Method for Rapid Retinization With Minimized Irritation.","OBJECTIVE The goal of this 12 week, double-blinded, controlled, clinical study was to compare the efficacy, tolerability, and consumer acceptance of three novel retinol serums to tretinoin. METHOD Forty-five photoaged females ages 35-65, Fitzpatrick skin types I-IV, with moderate wrinkling were enrolled in the 12-week study. A step-up protocol for increasing the dose of retinol serum (0.25%, 0.5%, 1.0%) or tretinoin cream (0.025%, 0.05%, and 0.1%) in combination with a test moisturizer or currently marketed dermatologist-recommended moisturizing cream was used. Overall severity of investigator graded photodamage, subject assessed photodamage, and tolerability criteria were evaluated using a 5-point ordinal scale at weeks 4, 8, and 12. Facial photography occurred at each visit and TEWL was measured at baseline and week 12. Histologic evaluation of punch biopsies was completed on baseline and week 12 samples. RESULTS After 12 weeks of use, both retinol serum and tretinoin demonstrated parity across investigator and subject assessment measurements as well as diagnostic measures including TEWL. Retinol serum subjects showed significant week 4 improvement in visual skin smoothness compared to tretinoin subjects (P=0.031). There was highly significant improvement in skin dryness with the retinol serum (P<0.001) not seen in the tretinoin group. Histologic analysis of baseline and 12-week punch biopsies demonstrated newly formed collagen and greater epidermal thickening in retinol serum subjects compared to tretinoin treated subjects. CONCLUSION Retinol serum (0.25%, 0.5%, 1.0%) was safe and effective with equivalent/or better performance and tolerability than tretinoin creams. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.5085.",2020,There was highly significant improvement in skin dryness with the retinol serum (P<0.001) not seen in the tretinoin group.,"['Escalating Doses', 'Forty-five photoaged females ages 35-65, Fitzpatrick skin types I-IV, with moderate wrinkling were enrolled in the 12-week study']","['tretinoin', 'tretinoin cream', 'retinol serum and tretinoin', 'Newly Formulated Retinol Serums vs Tretinoin Cream']","['Overall severity of investigator graded photodamage, subject assessed photodamage, and tolerability criteria', 'retinol serum', 'diagnostic measures including TEWL', 'Histologic evaluation of punch biopsies', 'efficacy, tolerability, and consumer acceptance', 'Retinol serum', 'visual skin smoothness', 'skin dryness', 'Facial photography', 'safe and effective with equivalent/or better performance and tolerability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C1252062', 'cui_str': 'Tretinoin Topical Cream'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0184924', 'cui_str': 'Punch biopsy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.0450016,There was highly significant improvement in skin dryness with the retinol serum (P<0.001) not seen in the tretinoin group.,"[{'ForeName': 'Zoe Diana', 'Initials': 'ZD', 'LastName': 'Draelos', 'Affiliation': ''}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Peterson', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5085'] 2467,32574011,New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis.,"BACKGROUND Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne. METHODS In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed. RESULTS Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P<0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P<0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups. CONCLUSIONS Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959.",2020,Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle.,"['Moderate-to-Severe Acne', 'patients aged 10-13 and 14-17 years with moderate-to-severe acne', 'Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled', 'patients with moderate-to-severe acne (N=1,614', 'pediatric patients with moderate-to-severe acne']","['New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation', 'tazarotene 0.045% lotion formulation', 'tazarotene 0.045% lotion or vehicle once-daily', 'Topical tazarotene', 'tazarotene', 'Tazarotene 0.045% lotion']","['efficacious and well tolerated', 'efficacy, safety, and tolerability', ""inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score"", 'inflammatory and noninflammatory lesion counts', 'Acne-QoL scores', 'lesion counts or treatment success', 'Quality of life (QoL) and adverse events (AEs']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C3215236', 'cui_str': 'Tazarotene-containing product in cutaneous dose form'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1614.0,0.0993488,Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle.,"[{'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ''}, {'ForeName': 'Emil A', 'Initials': 'EA', 'LastName': 'Tanghetti', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.4959'] 2468,32574094,Comparison of the added effects of kinesio taping and extracorporeal shockwave therapy to exercise alone in knee osteoarthritis.,"INTRODUCTION Pain and functional limitations affect quality of life of patients with knee osteoarthritis (OA). PURPOSE The purpose of this study was to compare the effects of two different applications (Kinesio taping; KT and Extracorporeal Shock Wave Therapy; ESWT) added to an home-exercise program on pain, strength and function in patients with knee OA. METHODS Sixty voluntary female subjects were randomly assigned into groups of; KT (n = 22), ESWT (n = 18) and control (CON) (n = 20) respectively. KT and ESWT were applied for 6 weeks and all the groups were taken home exercise program during 12 weeks in all groups. The outcome measures were; Visual Analog Scale for pain (during squat, rest and sleep), Isokinetic strength for quadriceps and hamstring strength, 'The Knee Injury and Osteoarthritis Outcome Survey', Timed Up & Go and 10 m Walk tests for function. The assessments were carried out at baseline, 6th and 12th weeks. RESULTS The mean age was 58.8 ± 6.2 years. Significant improvements were observed in all groups in all tests ( p < .05). There was no difference found between groups ( p > .05) except pain levels during sleep. CON group showed significant reduction in pain during sleep compared to ESWT group ( p < .05). CONCLUSION KT and ESWT have similar effects in terms of decreasing pain, improving knee strength and function in patients with knee OA. However it can be said that if a well-designed home exercise program were done by the patients correctly and regularly then it will be the best treatment option for patients with knee OA.",2020,There was no difference found between groups ( p > .05) except pain levels during sleep.,"['patients with knee OA', 'The mean age was 58.8\xa0±\xa06.2\xa0years', 'knee osteoarthritis', 'Sixty voluntary female subjects', 'patients with knee osteoarthritis (OA']","['applications (Kinesio taping; KT and Extracorporeal Shock Wave Therapy; ESWT', 'KT and ESWT', 'ESWT', 'kinesio taping and extracorporeal shockwave therapy', 'CON']","[""Visual Analog Scale for pain (during squat, rest and sleep), Isokinetic strength for quadriceps and hamstring strength, 'The Knee Injury and Osteoarthritis Outcome Survey', Timed Up & Go and 10 m Walk tests for function"", 'knee strength and function', 'pain levels', 'pain, strength and function', 'pain during sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",60.0,0.0197891,There was no difference found between groups ( p > .05) except pain levels during sleep.,"[{'ForeName': 'Özge Ece', 'Initials': 'ÖE', 'LastName': 'Günaydin', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Aydın Adnan Menderes University , Aydın, Turkey.'}, {'ForeName': 'Volga', 'Initials': 'V', 'LastName': 'Bayrakci Tunay', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University , Ankara, Turkey.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1780657'] 2469,32574096,"Boxing training in patients with stroke causes improvement of upper extremity, balance, and cognitive functions but should it be applied as virtual or real?","BACKGROUND Upper extremity hemiparesis is one of the most common post-stroke disabilities requiring rehabilitation. OBJECTIVE To compare the effects of virtual and real boxing training in addition to neurodevelopmental treatment on the upper extremity, balance, and cognitive functions in hemiparetic stroke patients. METHODS Forty hemiparetic stroke patients were assigned to either real boxing group-RBG (n=20) or virtual boxing group-VBG (n=20), for a total of 24 sessions (3 sessions/week for 8 weeks). The primary outcome was upper extremity motor ability (Wolf Motor Function Test-WMFT). The secondary outcomes were arm-hand dexterity (Manual Dexterity Test-MMDT), goal-oriented performance (Video Boxing Analysis-VBA), balance functions (Fullerton Advanced Balance Scale-FAB-T), and cognitive functions (Addenbrooke's Cognitive Examination-Revised-ACE-R). RESULTS There was small treatment effect on ACE-R, small-medium effect for WFMT and MMDT and large effect on bilateral punching time [VBA (Cohen's d- VBG=0.83; RBG=0.95)] and balance [FAB-T (Cohen's d - VBG=0.89; RBG=0.82)] after treatment in both groups. No significant differences were found for training effects between the groups for upper extremity functions [WMFT (p=0.799; Cohen's d=-0.07), MMDT-PT (p=0.327; Cohen's d=-0.10), MMDT-THTPT (p=0.779; Cohen's d=-0.17) and VBA bilateral punch number (p=0.068; Cohen's d=0.15)], balance functions [FAB-T (p=0.602; Cohen's d=-0.19)] and cognitive functions [ACE-R total (p=0.947, Cohen's d=0.09)]. CONCLUSION The study showed that virtual and real boxing training methods, in addition to neurodevelopmental treatment, are effective in improving upper extremity, balance, and cognitive functions in patients with hemiparetic stroke. The training effects were higher on bilateral punching time and balance functions for both groups. There was no superiority of either approach.",2020,"No significant differences were found for training effects between the groups for upper extremity functions [WMFT (p=0.799; Cohen's d=-0.07), MMDT-PT (p=0.327; Cohen's d=-0.10), MMDT-THTPT (p=0.779; Cohen's d=-0.17) and VBA bilateral punch number (p=0.068; Cohen's d=0.15)], balance functions [FAB-T (p=0.602; Cohen's d=-0.19)] and cognitive functions [ACE-R total (p=0.947, Cohen's d=0.09)]. ","['patients with hemiparetic stroke', 'Forty hemiparetic stroke patients', 'hemiparetic stroke patients', 'patients with stroke']","['virtual boxing group-VBG', 'virtual and real boxing training', 'real boxing group-RBG', 'Boxing training']","['upper extremity, balance, and cognitive functions', 'VBA bilateral punch number', ""arm-hand dexterity (Manual Dexterity Test-MMDT), goal-oriented performance (Video Boxing Analysis-VBA), balance functions (Fullerton Advanced Balance Scale-FAB-T), and cognitive functions (Addenbrooke's Cognitive Examination-Revised-ACE-R"", 'upper extremity motor ability (Wolf Motor Function Test-WMFT', 'balance functions [FAB-T', 'cognitive functions [ACE-R total', 'upper extremity functions [WMFT', 'bilateral punching time [VBA', 'bilateral punching time and balance functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0182555', 'cui_str': 'Punch'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0527811', 'cui_str': 'bakumondo-to'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021031', 'cui_str': 'Immunoglobulin, F(ab) fragment'}, {'cui': 'C2919447', 'cui_str': ""Addenbrooke's cognitive examination revised""}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0439112,"No significant differences were found for training effects between the groups for upper extremity functions [WMFT (p=0.799; Cohen's d=-0.07), MMDT-PT (p=0.327; Cohen's d=-0.10), MMDT-THTPT (p=0.779; Cohen's d=-0.17) and VBA bilateral punch number (p=0.068; Cohen's d=0.15)], balance functions [FAB-T (p=0.602; Cohen's d=-0.19)] and cognitive functions [ACE-R total (p=0.947, Cohen's d=0.09)]. ","[{'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Ersoy', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University Faculty of Health Sciences , Famagusta, Turkey.'}, {'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Iyigun', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University Faculty of Health Sciences , Famagusta, Turkey.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1783918'] 2470,32579567,School-based intervention to address self-regulation and executive functioning in children attending primary schools in remote Australian Aboriginal communities.,"Executive functioning and self-regulation influence a range of outcomes across the life course including physical and mental health, educational success, and employment. Children prenatally exposed to alcohol or early life trauma (ELT) are at higher risk of impairment of these skills and may require intervention to address self-regulation deficits. Researchers partnered with the local Aboriginal health organization and schools to develop and pilot a manualized version of the Alert Program® in the Fitzroy Valley, north Western Australia, a region with documented high rates of fetal alcohol spectrum disorder and ELT. This self-controlled cluster randomized trial evaluated the effect of an 8-week Alert Program® intervention on children's executive functioning and self-regulation skills. Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study. This reflects a 75% participation rate and indicates the strong community support that exists for the study. Teachers from 26 primary school classrooms across eight Fitzroy Valley schools received training to deliver eight, one-hour Alert Program® lessons over eight-weeks to students. Student outcomes were measured by parent and teacher ratings of children's behavioral, emotional, and cognitive regulation. The mean number of lessons attended by children was 4.2. Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior. The effectiveness of future self-regulation programs may be enhanced through multimodal delivery through home, school and community based settings to maximize children's exposure to the intervention. Despite mixed findings of effect, this study was an important first step in adapting and evaluating the Alert Program® for use in remote Australian Aboriginal community schools, where access to self-regulation interventions is limited.",2020,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","['Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study', 'children attending primary schools in remote Australian Aboriginal communities', ""children's executive functioning and self-regulation skills"", 'Teachers from 26 primary school classrooms across eight Fitzroy Valley schools', 'remote Australian Aboriginal community schools']","['alcohol or early life trauma (ELT', 'School-based intervention to address self-regulation and executive functioning', '8-week Alert Program® intervention']","[""parent and teacher ratings of children's behavioral, emotional, and cognitive regulation"", 'executive functioning and behavior', ""children's executive functioning skills or behavior"", 'physical and mental health, educational success, and employment']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",271.0,0.0226753,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","[{'ForeName': 'Bree', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Adams', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Carmichael Olson', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Symons', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Mazzucchelli', 'Affiliation': 'Child and Family Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Jirikowic', 'Affiliation': 'Division of Occupational Therapy, Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Watkins', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Cross', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boulton', 'Affiliation': 'The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Edie', 'Initials': 'E', 'LastName': 'Wright', 'Affiliation': 'Western Australian Department of Education Kimberley Education Region, Broome, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Carter', 'Affiliation': 'Nindilingarri Cultural Health Services, Fitzroy Crossing, Western Australia, Australia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fitzpatrick', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0234895'] 2471,32579674,Kin recognition and perceived facial similarity.,"Facial similarity between individuals informs kinship judgments in third-party kin recognition. Indeed, one study found that similarity and kinship judgments encapsulate the same information (Maloney & Dal Martello, 2006). Yet, another study found that this is not the case when comparing adult face pairs of different sex (DeBruine et al., 2009). We replicated these studies to further clarify the role of facial similarity in kin recognition. We recruited 318 raters, who were shown 50 sibling pairs and 50 age- and sex-matched unrelated pairs ranging from 3 to 17 years old. Each rater was randomly assigned to make either kinship judgments (""related"" or ""unrelated"") or similarity judgments (scale from 0 [not very similar] to 10 [very similar]). The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task. In both tasks, opposite-sex siblings were perceived to be siblings less often than same-sex siblings, and judgments of unrelated face pairs were not affected by the sex of faces. Conversely, the effect of age difference within pairs of faces differed for the two tasks: a greater age difference decreased all kinship judgments, but only decreased similarity judgments of siblings, not unrelated pairs. In line with DeBruine et al. (2009), these findings suggest that similarity and kinship judgments are highly correlated but not strictly synonymous. The OSF Pre-registration Challenge for this project can be found at osf.io/ps9hy and the data at osf.io/sef9k.",2020,"The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task.","['We recruited 318 raters, who were shown 50 sibling pairs and 50 age- and sex-matched unrelated pairs ranging from 3 to 17 years old']","['kinship judgments (""related"" or ""unrelated"") or similarity judgments (scale from 0 [not very similar] to 10 [very similar']","['Kin recognition and perceived facial similarity', 'Facial similarity']","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",,0.0189401,"The threshold model found that performance in both tasks was equally accurate, with participants detecting child siblings in the kinship task above chance and giving significantly higher similarity ratings to siblings in the similarity task.","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hansen', 'Affiliation': ',.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'DeBruine', 'Affiliation': '.'}, {'ForeName': 'Iris J', 'Initials': 'IJ', 'LastName': 'Holzleitner', 'Affiliation': '.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Lee', 'Affiliation': '.'}, {'ForeName': 'Kieran J', 'Initials': 'KJ', 'LastName': ""O'Shea"", 'Affiliation': '.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Fasolt', 'Affiliation': '.'}]",Journal of vision,['10.1167/jov.20.6.18'] 2472,32579773,Evaluation of Safety and Efficacy of Autologous Topical Platelet Gel versus Platelet Rich Plasma Injection in the Treatment of Venous Leg Ulcers: A randomized case control study.,"Various management options were tried for Chronic venous leg ulcers (VLUs) with no satisfactory results. Platelet-rich plasma (PRP) is promising in enhancing chronic wound healing by releasing various growth factors. We evaluated the safety and efficacy of topical platelet gel (PG) versus PRP injection in treatment of venous leg ulcers. 20 patients were treated with topical PG (group I), 20 patients received PRP injection (group II) and 20 patients were treated with saline dressing and compression as controls (group III) weekly for 6 weeks. Ulcer improvement was evaluated by pressure ulcer scale for healing (PUSH). Histopathological evaluation and immunohistochemical staining using anti-CD34 were performed before and after treatment. There was significant improvement in PUSH score in group (I) and group (II) compared to group (III) (P-value:0.001). However, there was no statistically significant difference in improvement between group I and II (P-value = 0.83). However, topical PG was more effective in diabetics and PRP was more effective in long standing fibrosed ulcers. Histopathology showed reduction of the inflammatory cells infiltrates and well-formed granulation tissue with no difference in immunostaining. So, both topical PG and PRP injection were effective, low cost and safe procedures in enhancing healing of chronic VLUs. This article is protected by copyright. All rights reserved.",2020,There was significant improvement in PUSH score in group (I) and group (II) compared to group (III) (P-value:0.001).,"['venous leg ulcers', '20 patients', 'Venous Leg Ulcers']","['topical PG', 'Platelet-rich plasma (PRP', 'topical platelet gel (PG', 'Autologous Topical Platelet Gel versus Platelet Rich Plasma Injection', 'saline dressing and compression as controls', 'PRP injection']","['PUSH score', 'safety and efficacy', 'inflammatory cells infiltrates and well-formed granulation tissue', 'pressure ulcer scale for healing (PUSH']","[{'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C2721313', 'cui_str': 'Sodium chloride dressing'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}]",20.0,0.0109079,There was significant improvement in PUSH score in group (I) and group (II) compared to group (III) (P-value:0.001).,"[{'ForeName': 'Lamia Hamouda', 'Initials': 'LH', 'LastName': 'Elgarhy', 'Affiliation': 'Department of Dermatology& Venereology, Department of Pathology, Faculty of medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amal Ahmad', 'Initials': 'AA', 'LastName': 'El-Ashmawy', 'Affiliation': 'Department of Dermatology& Venereology, Department of Pathology, Faculty of medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Asmaa Elsayed', 'Initials': 'AE', 'LastName': 'Bedeer', 'Affiliation': 'Department of Dermatology& Venereology, Department of Pathology, Faculty of medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Aya Mohammed', 'Initials': 'AM', 'LastName': 'Al Bahnassy', 'Affiliation': 'Department of Dermatology& Venereology, Department of Pathology, Faculty of medicine, Tanta University, Tanta, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13897'] 2473,32579779,Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery.,"BACKGROUND The optimum cardiac surgical pain management has known to maintain hemodynamic stability and, reduces respiratory and cardiovascular complications. Postoperative parasternal intercostal block has shown to reduce postoperative analgesic consumption after cardiac surgery. Therefore, this study sought to investigate the effectiveness of the preoperative ultrasound guided parasternal block in reducing postoperative pain after cardiac surgery. METHODS This was a randomized, prospective, interventional, single blind study comprised of 90 adult patients scheduled for cardiac surgery involving sternotomy. Preoperatively and postoperatively, 0.25% bupivacaine administered in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under ultrasound guidance and direct vision, respectively. Postoperative pain was rated according to visual analogue scale. Secondary outcomes included intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation. MAIN RESULTS There was no significant differences in visual analogue score visual analogue score at all time points till 24 hours postoperatively. Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72; P = .0001). Furthermore, there were no significant difference in total fentanyl requirement (7.20 ± 2.66 vs 8.37 ± 3.13; P = .06) and tramadol requirement (0.02 ± 0.15 vs 0.07 ± 0.26; P = .28) within first 24 hours. However, time to extubation was significantly higher in the preoperative group (P = .02). CONCLUSIONS Preoperative and postoperative parasternal intercostal block provide comparable pain relief during the postoperative period.",2020,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"['90 adult patients scheduled for cardiac surgery involving sternotomy', 'cardiac surgery']","['preoperative ultrasound guided parasternal block', 'bupivacaine', 'preincisional and postincisional parasternal intercostal block']","['visual analogue score visual analogue score', 'Intraoperative fentanyl requirements', 'total fentanyl requirement', 'pain relief', 'time to extubation', 'postoperative pain', 'postoperative analgesic consumption', 'intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation', 'Postoperative pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442146', 'cui_str': 'Parasternal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",90.0,0.116657,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"[{'ForeName': 'Sri Rama Ananta Nagabhushanam', 'Initials': 'SRAN', 'LastName': 'Padala', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ashok Shankar', 'Initials': 'AS', 'LastName': 'Badhe', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Satyen', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]",Journal of cardiac surgery,['10.1111/jocs.14651'] 2474,32579298,Comparison of the Pharmacokinetics of a Fixed-Dose Combination of Rosuvastatin/Metformin Sustained-Release (10/1000 mg) and Separate Tablets in Healthy Male Subjects.,"Fixed-dose combination (FDC) drugs with various dose combinations for the treatment of type 2 diabetes mellitus and dyslipidemia are currently in demand. We compared the pharmacokinetic (PK) profiles of the rosuvastatin/metformin sustained-release (10/1000 mg) FDC and separate tablets and evaluated the effect of food by randomized, open-label, 3-period, 6-sequence crossover studies conducted in healthy male subjects. Subjects were randomly assigned to one of the following treatments: separate tablets of 10 mg rosuvastatin and 1000 mg metformin sustained release in the fed state and the FDC in the fasted and fed states. PK samples were collected up to 72 hours postdose for rosuvastatin, N-desmethyl rosuvastatin, and metformin. The PK parameters were determined using a noncompartmental method, and the geometric mean ratio (GMR) and the 90% confidence interval (CI) of the treatments were calculated. A total of 35 subjects completed the study. The GMR and 90%CI of the peak concentration (C max ) and area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC last ) of the FDC and the separate tablets were within the bioequivalence criteria (0.8-1.25) for both rosuvastatin and metformin. The effect of food was statistically significant for both rosuvastatin and metformin but not expected to be of clinical significance.",2020,The effect of food was statistically significant for both rosuvastatin and metformin but not expected to be of clinical significance.,"['healthy male subjects', 'Healthy Male Subjects', '35 subjects completed the study']","['rosuvastatin and 1000 mg metformin', 'rosuvastatin/metformin', 'rosuvastatin, N-desmethyl rosuvastatin, and metformin', 'Rosuvastatin/Metformin Sustained-Release', 'Fixed-dose combination (FDC', 'rosuvastatin and metformin']","['geometric mean ratio (GMR', 'GMR and 90%CI of the peak concentration (C max ) and area under the plasma concentration-time curve']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4742542', 'cui_str': 'N-desmethyl rosuvastatin'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",35.0,0.0222156,The effect of food was statistically significant for both rosuvastatin and metformin but not expected to be of clinical significance.,"[{'ForeName': 'Ki Young', 'Initials': 'KY', 'LastName': 'Huh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Eunwoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Heechan', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Inseung', 'Initials': 'I', 'LastName': 'Jeon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hearan', 'Initials': 'H', 'LastName': 'Suh', 'Affiliation': 'Global Research Institute, Bcworld Pharm. Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Jongsun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Global Research Institute, Bcworld Pharm. Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Global Research Institute, Bcworld Pharm. Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.841'] 2475,32574006,A Randomized Comparison of Carbon Nanoparticles in Endoscopic Lymph Node Dissection Via the Bilateral Areola Approach for Papillary Thyroid Cancer.,"OBJECTIVE We assess the value of carbon nanoparticles (CNP) staining in patients undergoing endoscopic thyroidectomy and central compartment lymph node (CLN) dissection via the bilateral areola approach [endoscopic thyroidectomy via bilateral areola approach (ETBAA)]. METHODS This was a prospective randomized study. Three hundred two consecutive early-stage thyroid cancer patients eligible for ETBAA were recruited at the Division of Thyroid Surgery, China-Japan Union Hospital, Jilin University, China. CLN were mapped and retrieved under the guidance of stained or unstained CNP. The location, detection rates, positive nodes, and number of stained lymph nodes were compared. RESULTS ETBAA patients were randomly divided into a CNP group (n=152) and a control group (n=150). In the CNP group, the imaging of lymphatic flow could be observed in 1016 (95.9%) lymph nodes, whereas 43 (4.1%) were unstained. The mean number of stained lymph nodes in each procedure was 6.68 (range, 3 to 12). The total number of dissected lymph nodes was 1059 in the CNP group and 872 in the control group (P=0.00). There was a significant difference of inadvertent parathyroidectomy between the 2 groups: 0.5% versus 3.9% in lobectomy (P=0.035) and 0.6% versus 5.2% in total thyroidectomy (P=0.012). However, the rates of hypoparathyroidism were not significantly different (P>0.05). There were no cases of CNP-related adverse effects. CONCLUSIONS The lymphatic navigation by CNP increases the number of detected CLN without the involvement of radioactive isotopes. However, CNP did not lower hypocalcemia, did not improve parathyroid hormone range, and there was no significant difference in the percentage of metastatic lymph nodes between the 2 groups.",2020,There was a significant difference of inadvertent parathyroidectomy between the 2 groups: 0.5% versus 3.9% in lobectomy (P=0.035) and 0.6% versus 5.2% in total thyroidectomy (P=0.012).,"['Endoscopic Lymph Node Dissection', 'Three hundred two consecutive early-stage thyroid cancer patients eligible for ETBAA were recruited at the Division of Thyroid Surgery, China-Japan Union Hospital, Jilin University, China', 'patients undergoing endoscopic thyroidectomy and central compartment lymph node (CLN) dissection via the bilateral areola approach ', 'Papillary Thyroid Cancer']","['carbon nanoparticles (CNP) staining', 'endoscopic thyroidectomy via bilateral areola approach (ETBAA', 'Carbon Nanoparticles', 'CNP']","['total number of dissected lymph nodes', 'hypocalcemia', 'mean number of stained lymph nodes', 'location, detection rates, positive nodes, and number of stained lymph nodes', 'percentage of metastatic lymph nodes', 'inadvertent parathyroidectomy', 'rates of hypoparathyroidism', 'imaging of lymphatic flow', 'parathyroid hormone range']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",302.0,0.0547605,There was a significant difference of inadvertent parathyroidectomy between the 2 groups: 0.5% versus 3.9% in lobectomy (P=0.035) and 0.6% versus 5.2% in total thyroidectomy (P=0.012).,"[{'ForeName': 'Daqi', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Yantao', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Gianlorenzo', 'Initials': 'G', 'LastName': 'Dionigi', 'Affiliation': 'Department of Human Pathology in Adulthood and Childhood ""G. Barresi"", Division for Endocrine and Minimally Invasive Surgery, University Hospital G. Martino, University of Messina, Messina, Italy.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Division of Pathology, China-Japan Union Hospital of Jilin University, Changchun City, Jilin Province, People's Republic of China.""}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Xue', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Division of Thyroid Surgery, China-Japan Union Hospital of Jilin University, Jilin Provincial Key Laboratory of Surgical Translational Medicine, Jilin Provincial Precision Medicine Laboratory of Molecular Biology and Translational Medicine on Differentiated Thyroid Carcinoma.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000793'] 2476,32574117,Randomized Trial Comparing Double Versus Triple Bortezomib-Based Regimen in Patients With Multiple Myeloma and Acute Kidney Injury Due to Cast Nephropathy.,"PURPOSE We report a multicenter controlled trial comparing renal recovery and tolerance profile of doublet versus triplet bortezomib-based regimens in patients with initial myeloma cast nephropathy (CN) and acute kidney injury (AKI) without need for dialysis. METHODS After symptomatic measures and high-dose dexamethasone, patients were randomly assigned to receive bortezomib plus dexamethasone (BD), or BD plus cyclophosphamide (C-BD). In patients with < 50% reduction of serum free light chains (sFLCs) after 3 cycles, chemotherapy was reinforced with either cyclophosphamide (BD group) or thalidomide (C-BD group). RESULTS Ninety-two patients were enrolled in each group. At random assignment, characteristics of the 2 groups were similar, including median age (68 years) and serum creatinine level (305.5 and 273.5 µmol/L in BD and C-BD group, respectively). At 3 months, renal response rate (primary end point) was not different (41 v 47 responders in the BD and C-BD groups, respectively; relative risk [RR], 0.87; P = .46). Very good partial response (free light chain reduction ≥ 90%) or more was achieved in 36 and 47 patients, respectively (RR, 0.76; P = .10). After 1 cycle of chemotherapy, 69 in the BD group and 67 patients in the C-BD group had achieved sFLC level ≤ 500 mg/L. Serious adverse events were recorded in 30 and 40 patients, respectively. At 12 months, 19 patients had died (9 in the BD group v 10 in the C-BD group), including 10 (6 in the BD group and 4 in the C-BD group) from myeloma progression and 3 (0 in the BD group and 3 in the C-BD group) from infection. Within median follow-up of 27 months, 43 and 42 patients switched to new therapy, respectively. Overall, 50 patients (24 in the BD group and 26 in the C-BD group) had died. CONCLUSION This randomized study did not show any benefit of C-BD compared with BD on renal recovery of patients with initial CN not requiring dialysis. Adding cyclophosphamide did not sufficiently improve the efficacy-toxicity balance. Patients with myeloma with AKI are fragile, and indication for doublet or triplet regimen should be adapted to frailty.",2020,"Very good partial response (free light chain reduction ≥ 90%) or more was achieved in 36 and 47 patients, respectively (RR, 0.76; P = .10).","['Patients with myeloma with AKI', 'patients with initial CN not requiring dialysis', 'Ninety-two patients were enrolled in each group', 'patients with initial myeloma cast nephropathy (CN) and acute kidney injury (AKI) without need for dialysis', 'Patients With Multiple Myeloma and Acute Kidney Injury']","['BD', 'cyclophosphamide', 'dexamethasone', 'bortezomib plus dexamethasone (BD), or BD plus cyclophosphamide (C-BD', 'C-BD', 'cyclophosphamide (BD group) or thalidomide', 'doublet versus triplet bortezomib-based regimens', 'Triple Bortezomib-Based Regimen']","['sFLC level', 'serum creatinine level', 'died', 'renal recovery', 'adverse events', 'renal response rate', 'efficacy-toxicity balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0268784', 'cui_str': 'Myeloma kidney'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",92.0,0.0487875,"Very good partial response (free light chain reduction ≥ 90%) or more was achieved in 36 and 47 patients, respectively (RR, 0.76; P = .10).","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bridoux', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire de Poitiers, INSERM CIC 1402, Poitiers University, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Arnulf', 'Affiliation': 'Department of Hematology and Immunology, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, INSERM UMR 1126, Paris, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Karlin', 'Affiliation': 'Department of Clinical Hematology, Centre Hospitalier Universitaire Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Blin', 'Affiliation': 'Department of Hematology, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Nolwenn', 'Initials': 'N', 'LastName': 'Rabot', 'Affiliation': 'Department of Nephrology and Clinical Immunology, Hôpital Bretonneau, Centre Hospitalier Universitaire de Tours, Tours, France.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Macro', 'Affiliation': 'Department of Hematology, Centre Hospitalier Universitaire de Caen, Caen, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Audard', 'Affiliation': 'Department of Nephrology and Renal Transplantation, Hôpital Henri Mondor, Créteil, Assistance Publique-Hôpitaux de Paris, INSERM U955, Université Paris Est Créteil, Créteil, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Belhadj', 'Affiliation': 'Department of Hematology, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Pegourie', 'Affiliation': 'Department of Hematology, Centre Hospitalier Universitaire de Grenoble, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Avignon, and Clinique Rhône Durance, Avignon, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Cornec Le Gall', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire de Brest, INSERM U1078, Université de Brest, Brest, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Joly', 'Affiliation': 'Department of Hematology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Karras', 'Affiliation': 'Department of Nephrology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'Centre de référence maladies rares ""amylose AL et autres maladies par dépôt d\'immunoglobulines monoclonales,"" Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Augeul-Meunier', 'Affiliation': 'Department of Hematology, Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, France.'}, {'ForeName': 'Salomon', 'Initials': 'S', 'LastName': 'Manier', 'Affiliation': 'Department of Hematology, Centre Hospitalier Universitaire de Lille, INSERM UMR-S1172, University of Lille, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Royer', 'Affiliation': ""Department of Hematology, Centre Hospitalier Universitaire d'Amiens, Amiens, France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': 'Department of Clinical Hematology, Centre Hospitalier Universitaire de Dijon, Dijon, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Tiab', 'Affiliation': 'Department of Clinical Hematology, Centre Hospitalier de Vendée, La Roche sur Yon, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Delbes', 'Affiliation': 'Department of Nephrology, Centre Hospitalier La Rochelle, La Rochelle, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Suarez', 'Affiliation': 'Department of Hematology, Hôpital Necker, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Vigneau', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire Pontchaillou, Rennes, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Caillard', 'Affiliation': 'Department of Nephrology and Transplantation, Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Arakelyan-Laboure', 'Affiliation': ""Department of Clinical Hematology and Cellular Therapy, Centre Hospitalier Régional d'Orléans, Orléans, France.""}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Roos-Weil', 'Affiliation': 'Department of Clinical Hematology, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': 'Department of Biostatistics and Medical Information, UMR 1153, ECSTRRA Team, Inserm, Paris Diderot University, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jean Paul', 'Initials': 'JP', 'LastName': 'Fermand', 'Affiliation': 'Department of Hematology and Immunology, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, INSERM UMR 1126, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00298'] 2477,32574167,On-line anxiety level detection from biosignals: Machine learning based on a randomized controlled trial with spider-fearful individuals.,"We present performance results concerning the validation for anxiety level detection based on trained mathematical models using supervised machine learning techniques. The model training is based on biosignals acquired in a randomized controlled trial. Wearable sensors were used to collect electrocardiogram, electrodermal activity, and respiration from spider-fearful individuals. We designed and applied ten approaches for data labeling considering individual biosignals as well as subjective ratings. Performance results revealed a selection of trained models adapted for two-level (low and high) and three-level (low, medium and high) classification of anxiety using a minimal set of six features. We obtained a remarkable accuracy of 89.8% for the two-level classification and of 74.4% for the three-level classification using a short time window length of ten seconds when applying the approach that uses subjective ratings for data labeling. Bagged Trees proved to be the most suitable classifier type among the classification models studied. The trained models will have a practical impact on the feasibility study of an augmented reality exposure therapy based on a therapeutic game for the treatment of arachnophobia.",2020,We obtained a remarkable accuracy of 89.8% for the two-level classification and of 74.4% for the three-level classification using a short time window length of ten seconds when applying the approach that uses subjective ratings for data labeling.,['spider-fearful individuals'],[],[],"[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],[],,0.0208422,We obtained a remarkable accuracy of 89.8% for the two-level classification and of 74.4% for the three-level classification using a short time window length of ten seconds when applying the approach that uses subjective ratings for data labeling.,"[{'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Ihmig', 'Affiliation': 'Department of Biomedical Microsystems, Fraunhofer-Institut für Biomedizinische Technik IBMT, Sulzbach/Saar, Germany.'}, {'ForeName': 'Antonio Gogeascoechea', 'Initials': 'AG', 'LastName': 'H', 'Affiliation': 'Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Neurohr-Parakenings', 'Affiliation': 'Department of Biomedical Microsystems, Fraunhofer-Institut für Biomedizinische Technik IBMT, Sulzbach/Saar, Germany.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Schäfer', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lass-Hennemann', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",PloS one,['10.1371/journal.pone.0231517'] 2478,32574173,Foreskin surface area is not associated with sub-preputial microbiome composition or penile cytokines.,"OBJECTIVE Male circumcision (MC) reduces acquisition of HIV-1 in heterosexual men by at least 60%, but the biological mechanism for this protection is incompletely understood. Previous studies have shown that a larger foreskin size, increased abundance of anaerobic bacteria in the sub-preputial space, and higher levels of pro-inflammatory cytokines on the penis are all prospectively associated with risk of HIV-1 acquisition. Since coverage of the glans on the non-erect penis is dependent on foreskin size, a larger foreskin could result in a less aerobic environment that might preferentially support anaerobic bacterial growth and induce inflammation. We therefore assessed the relationship between foreskin size, penile microbiome composition and local inflammation. METHODS This is a retrospective, cross-sectional analysis of 82 HIV-uninfected men who participated in a randomized trial of MC for HIV-1 prevention in Rakai, Uganda between 2003-2006. Sub-preputial swabs were collected prior to MC and assessed for cytokines (multiplexed immunosorbent assay) and bacterial load (qPCR) and taxon abundance (sequencing). Foreskin size was measured immediately after MC. RESULTS Foreskin surface area did not correlate with total bacterial load (rho = 0.05) nor the abundance of key taxa of bacteria previously associated with HIV-1 risk (rho = 0.04-0.25). Foreskin surface area also did not correlate with sub-preputial cytokine concentrations previously associated with HIV-1 risk (IL-8 rho = 0.05). CONCLUSIONS Larger foreskin size is not associated with either increased penile anaerobes or pro-inflammatory cytokines. These data suggest that foreskin size does not increase HIV-1 risk through changes in penile microbiome composition or penile inflammation.",2020,"RESULTS Foreskin surface area did not correlate with total bacterial load (rho = 0.05) nor the abundance of key taxa of bacteria previously associated with HIV-1 risk (rho = 0.04-0.25).","['heterosexual men', '82 HIV-uninfected men who participated in a randomized trial of MC for HIV-1 prevention in Rakai, Uganda between 2003-2006']",['Male circumcision (MC'],"['Foreskin size', 'cytokines (multiplexed immunosorbent assay) and bacterial load (qPCR) and taxon abundance (sequencing', 'total bacterial load']","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0008819', 'cui_str': 'Circumcision'}]","[{'cui': 'C0227952', 'cui_str': 'Preputial structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021075', 'cui_str': 'Immunoadsorbents'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.061171,"RESULTS Foreskin surface area did not correlate with total bacterial load (rho = 0.05) nor the abundance of key taxa of bacteria previously associated with HIV-1 risk (rho = 0.04-0.25).","[{'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Liu', 'Affiliation': 'Department of Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States of America.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Packman', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Gray', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Kaul', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Aaron A R', 'Initials': 'AAR', 'LastName': 'Tobian', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Abraham', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ssekasanvu', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kagaayi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Prodger', 'Affiliation': 'Department of Microbiology and Immunology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0234256'] 2479,32574181,It's how you say it: Systematic A/B testing of digital messaging cut hospital no-show rates.,"Failure to attend hospital appointments has a detrimental impact on care quality. Documented efforts to address this challenge have only modestly decreased no-show rates. Behavioral economics theory has suggested that more effective messages may lead to increased responsiveness. In complex, real-world settings, it has proven difficult to predict the optimal message composition. In this study, we aimed to systematically compare the effects of several pre-appointment message formats on no-show rates. We randomly assigned members from Clalit Health Services (CHS), the largest payer-provider healthcare organization in Israel, who had scheduled outpatient clinic appointments in 14 CHS hospitals, to one of nine groups. Each individual received a pre-appointment SMS text reminder five days before the appointment, which differed by group. No-show and advanced cancellation rates were compared between the eight alternative messages, with the previously used generic message serving as the control. There were 161,587 CHS members who received pre-appointment reminder messages who were included in this study. Five message frames significantly differed from the control group. Members who received a reminder designed to evoke emotional guilt had a no-show rates of 14.2%, compared with 21.1% in the control group (odds ratio [OR]: 0.69, 95% confidence interval [CI]: 0.67, 0.76), and an advanced cancellation rate of 26.3% compared with 17.2% in the control group (OR: 1.2, 95% CI: 1.19, 1.21). Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format. Carefully selecting the narrative of pre-appointment SMS reminders can lead to a marked decrease in no-show rates. The process of a/b testing, selecting, and adopting optimal messages is a practical example of implementing the learning healthcare system paradigm, which could prevent up to one-third of the 352,000 annually unattended appointments in Israel.",2020,"Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format.","['161,587 CHS members who received pre-appointment reminder messages who were included in this study']","['Clalit Health Services (CHS), the largest payer-provider healthcare organization in Israel, who had scheduled outpatient clinic appointments']","['advanced cancellation rates', 'advanced cancellation rate']","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}]",,0.0627862,"Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format.","[{'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Berliner Senderey', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kornitzer', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Lawrence', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}, {'ForeName': 'Hilla', 'Initials': 'H', 'LastName': 'Zysman', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Hallak', 'Affiliation': 'Fuqua School of Business, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Balicer', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}]",PloS one,['10.1371/journal.pone.0234817'] 2480,32574223,A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults.,"PURPOSE Nitrate (NO3-), through its conversion to nitrite (NO2-) and nitric oxide, has been shown to increase exercise tolerance in healthy younger adults and older diseased patients. Nitrate's effect in well-trained middle to older-aged adults has not been studied. Therefore, the purpose of this investigation was to examine the effects of a NO3- rich beverage on submaximal constant work rate exercise time in well-trained middle to older-aged adults. METHODS This was a randomized controlled cross-over trial with 15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments (NO3- rich beverage then placebo or placebo then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed. RESULTS The NO3- rich beverage increased plasma NO3- and NO2- levels by 260 μM and 0.47 μM, respectively (p<0.001). Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (1130±151 vs 1060±132 sec, respectively). Changes in exercise time between the two conditions ranged from a 55% improvement to a 40% decrease with the NO3- rich beverage. Oxygen consumption and rating of perceived exertion were not significantly different between the two conditions. CONCLUSION In middle to older-aged well-trained adults, NO3- supplementation has non-significant, albeit highly variable, effects on exercise tolerance. ClinicalTrials.gov Identifier: NCT03371966.",2020,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"['healthy younger adults and older diseased patients', 'well-trained middle to older-aged adults', 'well-trained middle and older-aged adults', ""then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed"", '15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments']","['NO3- rich beverage then placebo or placebo', 'nitrate supplementation', 'NO3- rich beverage']","['exercise time', 'Exercise time', 'exercise tolerance', 'submaximal constant work rate exercise time', 'plasma NO3- and NO2- levels', 'Oxygen consumption and rating of perceived exertion']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.426141,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Macie S', 'Initials': 'MS', 'LastName': 'Fletcher', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Caleb G', 'Initials': 'CG', 'LastName': 'Jones', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Gauthier', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Summer L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Heinrich', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0235047'] 2481,32574506,Hyperbaric Oxygen and Focused Rehabilitation Program: A Feasibility Study in Improving Upper Limb Motor Function After Stroke.,"Neuroplasticity and recovery after stroke can be enhanced by a rehabilitation program pertinent to upper limb motor function exercise and mental imagery (EMI) as well as hyperbaric oxygen therapy (HBOT). We assessed the feasibility and safety of the combined approach utilizing both HBOT and EMI, and derived preliminary estimates of its efficacy. In this randomized controlled trial, twenty-seven patients with upper extremity hemiparesis 3-48 months after stroke were randomized to receive either a complementary rehabilitation program HBOT-EMI (intervention group), or EMI alone (control group). Feasibility and safety were assessed as total session attendance, duration of sessions, attrition rates, missing data, and intervention-related adverse events. Secondary clinical outcomes were assessed with both objective tools and self-reported measures at baseline, 8 weeks (end of treatment), and 12-weeks follow-up. Session attendance, duration and attrition rate did not differ between the groups; there were no serious adverse events. Compared to baseline, there were significant sustained improvements of objective and subjective outcomes' measures in the intervention group, and a single improvement in an objective measure in the control group. Between-group outcome comparisons were not statistically significant. This study demonstrated that the combination HBOT-EMI was a safe and feasible approach in patients recovering from chronic stroke. There were also trends for improved motor function of the affected upper limb after the treatments. Registration-URL:https://www.clinicaltrials.com NCT02666469. NOVELTY: - HBOT combined with an upper limb exercise and mental imagery rehabilitation program is feasible and safe in chronic stroke patients. - This combined approach showed trends for improved functional recovery.",2020,"Session attendance, duration and attrition rate did not differ between the groups; there were no serious adverse events.","['twenty-seven patients with upper extremity hemiparesis 3-48 months after stroke', 'patients recovering from chronic stroke', 'chronic stroke patients']","['HBOT combined with an upper limb exercise and mental imagery rehabilitation program', 'complementary rehabilitation program HBOT-EMI (intervention group), or EMI alone (control group', 'combination HBOT-EMI', 'hyperbaric oxygen therapy (HBOT', 'Hyperbaric Oxygen and Focused Rehabilitation Program']","['total session attendance, duration of sessions, attrition rates, missing data, and intervention-related adverse events', 'Session attendance, duration and attrition rate', 'feasibility and safety', 'Feasibility and safety', 'functional recovery', 'motor function']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",27.0,0.0375018,"Session attendance, duration and attrition rate did not differ between the groups; there were no serious adverse events.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schiavo', 'Affiliation': 'University of Toronto Department of Anesthesia, 177410, Hyperbaric medicine, Toronto, Ontario, Canada ; simone.schiavo@mail.utoronto.ca.'}, {'ForeName': 'Denyse', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Toronto Rehabilitation Institute, 7961, Stroke Rehabilitation Clinic, Toronto, Ontario, Canada ; denyse.richardson@uhn.ca.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Santa Mina', 'Affiliation': 'University of Toronto Faculty of Kinesiology and Physical Education, 177420, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Buryk-Iggers', 'Affiliation': 'University of Toronto Faculty of Kinesiology and Physical Education, 177420, Toronto, Ontario, Canada ; stephanie.buryk@uhnresearch.ca.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Uehling', 'Affiliation': 'University of Toronto Department of Anesthesia, 177410, Hyperbaric medicine, Toronto, Ontario, Canada ; jjmuehling@aol.com.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'University of Toronto Department of Anesthesia, 177410, Hyperbaric medicine, Toronto, Ontario, Canada ; jo.carroll@uhn.ca.'}, {'ForeName': 'Hance', 'Initials': 'H', 'LastName': 'Clarke', 'Affiliation': 'University of Toronto Department of Anesthesia, 177410, Hyperbaric medicine, Toronto, Ontario, Canada ; hance.clarke@uhn.ca.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Djaiani', 'Affiliation': 'University of Toronto Department of Anesthesia, 177410, Hyperbaric medicine, Toronto, Ontario, Canada ; carine.djaiani@hotmail.com.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Gershinsky', 'Affiliation': 'University of Toronto Department of Anesthesia, 177410, Hyperbaric medicine, Toronto, Ontario, Canada ; max.gershinsky@yahoo.com.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Katznelson', 'Affiliation': 'University of Toronto Department of Anesthesia, 177410, Hyperbaric medicine, Toronto, Ontario, Canada ; rita.katznelson@uhn.ca.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0124'] 2482,32574587,"Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial.","BACKGROUND Children with severe atopic dermatitis (AD) have limited treatment options. OBJECTIVE We report efficacy and safety of dupilumab + topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies. METHODS In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 to 300mg dupilumab every 4 weeks (300mg-q4w), a weight-based regimen of dupilumab every 2 weeks (100mg-q2w, baseline weight <30kg; 200mg-q2w, ≥30kg), or placebo; with concomitant medium-potency TCS. RESULTS Both the q4w and q2w dupilumab+TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QoL) versus placebo+TCS in all prespecified endpoints. For q4w/q2w/placebo, 32.8%/29.5%/11.4% of patients achieved Investigator's Global Assessment scores of 0/1; 69.7%/67.2%/26.8% achieved ≥75% improvement in Eczema Area and Severity Index scores; and 50.8%/58.3%/12.3% achieved ≥4-point reduction in worst itch score. Response to therapy was weight-dependent: optimal dupilumab doses for efficacy and safety were 300mg-q4w in children <30kg and 200mg-q2w in children ≥30kg. Conjunctivitis and injection-site reactions were more common with dupilumab+TCS than placebo+TCS. LIMITATIONS Short-term 16-week treatment period; severe AD only. CONCLUSION Dupilumab+TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QoL.",2020,"Both the q4w and q2w dupilumab+TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QoL) versus placebo+TCS in all prespecified endpoints.","['children aged 6-11 years with severe AD inadequately controlled with topical therapies', 'Children with severe atopic dermatitis (AD', '367 patients', 'children with severe AD', 'children 6 to 11 years old with severe atopic dermatitis']","['Dupilumab+TCS', 'dupilumab with concomitant topical corticosteroids', 'placebo; with concomitant medium-potency TCS', 'dupilumab+TCS', 'dupilumab + topical corticosteroids (TCS', 'placebo']","['signs, symptoms, and quality of life (QoL', 'Eczema Area and Severity Index scores', 'Efficacy and safety', 'efficacy and safety', 'Conjunctivitis and injection-site reactions', ""Investigator's Global Assessment scores""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",367.0,0.54447,"Both the q4w and q2w dupilumab+TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QoL) versus placebo+TCS in all prespecified endpoints.","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': ""Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.""}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': ""Saint Louis University, St. Louis, MO, USA; Cardinal Glennon Children's Hospital, St. Louis, MO, USA.""}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Arkwright', 'Affiliation': 'Lydia Becker Institute of Immunology & Inflammation, University of Manchester, Manchester, UK.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""Probity Medical Research, Peterborough, ON, Canada; SKiN Centre for Dermatology, Peterborough, ON, Canada; Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'National Jewish Health, Denver, CO, USA; University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, CA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Advanced Medical Research, PC, Atlanta, GA, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': ""O'Malley"", 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hardin', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Faisal A', 'Initials': 'FA', 'LastName': 'Khokhar', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Beazley', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA. Electronic address: Brad.shumel@regeneron.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.054'] 2483,32574657,The Feasibility and Acceptability of a Cognitive Behavioral Therapy-based intervention for Patients with Advanced Colorectal Cancer.,"Context/ objectives: Advanced colorectal cancer and its treatment can bring about challenges associated with psychological distress. The primary aims of this study were to examine the feasibility and acceptability of a cognitive behavioral therapy (CBT)-based intervention to improve coping with the disease. The secondary aim is to evaluate preliminary intervention efficacy. METHODS Patients with advanced colorectal cancer in Singapore (N = 60) were randomized to either receive a 4-session CBT intervention immediately or be waitlisted. Intervention feasibility (i.e., recruitment and intervention adherence) and acceptability (i.e., participant satisfaction and cultural sensitivity) were assessed. Changes in psychological distress and self-efficacy were examined. RESULTS The study successfully recruited the intended sample (M age = 61, 62% men). A proportion (12%) reported Hospital Anxiety and Depression Scale (HADS) scores indicative of distress at baseline. The majority (88%) completed all sessions. Participants reported high rates of satisfaction (97%), helpfulness (96%) and cultural sensitivity (95%) of the intervention. The intervention group did not show decrease in psychological distress; however, self-efficacy in cancer-related coping (information seeking, effect size (ES) = 0.64, 95%CI [0.17, 0.85]; coping with side effects, ES=0.69, 95%CI [0.33, 0.82]; and maintaining positive attitude, ES=0.45, 95%CI [0.19, 0.79]) increased in the intervention group compared to the waitlisted group. CONCLUSION The CBT-based intervention was feasible and acceptable to patients in Singapore. There is not sufficient evidence to warrant a larger trial in this sample with low baseline distress. Future work should identify and target those who are most in need of support.",2020,"The intervention group did not show decrease in psychological distress; however, self-efficacy in cancer-related coping (information seeking, effect size (ES) = 0.64, 95%CI [0.17, 0.85]; coping with side effects, ES=0.69, 95%CI [0.33, 0.82]; and maintaining positive attitude, ES=0.45, 95%CI [0.19, 0.79]) increased in the intervention group compared to the waitlisted group. ","['Patients with advanced colorectal cancer in Singapore (N = 60', 'The study successfully recruited the intended sample (M age = 61, 62% men', 'Patients with Advanced Colorectal Cancer']","['Cognitive Behavioral Therapy-based intervention', 'cognitive behavioral therapy (CBT)-based intervention', '4-session CBT intervention immediately or be waitlisted']","['Intervention feasibility (i.e., recruitment and intervention adherence) and acceptability (i.e., participant satisfaction and cultural sensitivity', 'psychological distress and self-efficacy', 'cultural sensitivity', 'feasibility and acceptability', 'rates of satisfaction', 'Hospital Anxiety and Depression Scale (HADS) scores indicative of distress', 'self-efficacy in cancer-related coping (information seeking, effect size (ES', 'psychological distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",60.0,0.0706234,"The intervention group did not show decrease in psychological distress; however, self-efficacy in cancer-related coping (information seeking, effect size (ES) = 0.64, 95%CI [0.17, 0.85]; coping with side effects, ES=0.69, 95%CI [0.33, 0.82]; and maintaining positive attitude, ES=0.45, 95%CI [0.19, 0.79]) increased in the intervention group compared to the waitlisted group. ","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Teo', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Department of Psychosocial Oncology, National Cancer Centre Singapore, Singapore; Programme in Health Services & Systems Research, Duke-NUS Medical School, Singapore. Electronic address: irene.teo@duke-nus.edu.sg.'}, {'ForeName': 'Yee Pin', 'Initials': 'YP', 'LastName': 'Tan', 'Affiliation': 'Department of Psychosocial Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Programme in Health Services & Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Grace Meijuan', 'Initials': 'GM', 'LastName': 'Yang', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Division of Supportive and Palliative Care, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Fang Ting', 'Initials': 'FT', 'LastName': 'Pan', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Henry Yuen Foong', 'Initials': 'HYF', 'LastName': 'Lew', 'Affiliation': 'Department of Psychology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Emile Kwong Wei', 'Initials': 'EKW', 'LastName': 'Tan', 'Affiliation': 'Department of Colorectal Surgery, Singapore General Hospital, Singapore.'}, {'ForeName': 'Simon Yew Kuang', 'Initials': 'SYK', 'LastName': 'Ong', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Programme in Health Services & Systems Research, Duke-NUS Medical School, Singapore; Division of Medical Oncology, National Cancer Centre Singapore, Singapore; Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.06.016'] 2484,32574716,Stevens-Johnson Syndrome Secondary to Doxycycline Treatment in a Teenage Boy.,,2020,,[],['Doxycycline'],[],[],"[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}]",[],,0.0152077,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Morgado-Carrasco', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'González Enseñat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Prat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vicente-Villa', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España. Electronic address: avicente@sjdhospitalbarcelona.org.'}]",Actas dermo-sifiliograficas,['10.1016/j.ad.2019.02.021'] 2485,32574722,HSD3B1 (1245A>C) germline variant and clinical outcomes in metastatic castration-resistant prostate cancer patients treated with abiraterone and enzalutamide: results from two prospective studies.,"BACKGROUND A common polymorphism (1245A>C) in the HSD3B1 gene is associated with increased de-novo synthesis of androgens and worse outcomes in men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer. The objective of the study was to determine whether this polymorphism is associated with outcomes for metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone or enzalutamide. PATIENTS AND METHODS A total of 547 patients treated with abiraterone or enzalutamide from two prospective cohorts were evaluated. HSD3B1 genotype was determined by targeted sequencing and/or Taqman SNP genotyping. In cohort 1, patients were randomized to receive abiraterone + prednisone or enzalutamide. In cohort 2, patients received either agent per investigator's choice. PSA response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival (OS) were determined. Associations between HSD3B1 genotypes and outcomes were evaluated via univariate COX regression. Multivariable COX model was used to determine the independent association of each covariate. RESULTS HSD3B1 variant genotype (CC) was present in 15% of patients and was associated with worse TTP (HR 1.31, 95% CI 1.02-1.67, p=0.032) and PSA response rates (48% for CC vs 62% and 65% for AA and AC, respectively (p=0.019)), with no significant difference in TTPP (HR 1.28, 95%CI 0.99-1.66, p=0.064). The effect of genotype was similar for treatment with abiraterone or enzalutamide with a negative test for interaction for TTPP (p=0.997) and TTP (p=0.749). Multivariable analysis did not show a significant association between genotype and TTP or TTPP. CONCLUSIONS HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide. However, the CC genotype did not provide prognostic information beyond that conferred by standard clinical variables, suggesting that it may not be a suitable stand-alone biomarker in mCRPC.",2020,"CONCLUSIONS HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","['metastatic castration-resistant prostate cancer (mCRPC) treated with', 'metastatic castration-resistant prostate cancer patients treated with', 'men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer', '547 patients treated with']","['abiraterone + prednisone or enzalutamide', 'abiraterone and enzalutamide', 'abiraterone or enzalutamide']","['PSA response rate', 'PSA response rates', 'PSA response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival (OS', 'HSD3B1 variant genotype (CC', 'TTPP']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]",547.0,0.123766,"CONCLUSIONS HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'BC Cancer Vancouver, Vancouver, British Columbia, Canada.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Aragón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA).'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lozano', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA).'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taavitsainen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorente', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Hospital General Universitari de Castelló, Castellon, Spain.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Finch', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; BC Cancer Kelowna, Kelowna, British Columbia, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Romero-Laorden', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Medical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vergidis', 'Affiliation': 'BC Cancer Victoria, Victoria, British Columbia, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cendón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oja', 'Affiliation': 'BC Cancer Surrey, Surrey, British Columbia, Canada.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Pacheco', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'BC Cancer Abbotsford, Abbotsford, British Columbia, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Gleave', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA); Medical Oncology Department, Hospital Universitario Virgen de la Victoria y Regional de Málaga, Spain.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer Vancouver, Vancouver, British Columbia, Canada; Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castro', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA); Medical Oncology Department, Hospital Universitario Virgen de la Victoria y Regional de Málaga, Spain. Electronic address: elena.castro@ibima.eu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.006'] 2486,32442746,The effect of mirror therapy after carpal tunnel syndrome surgery: A randomised controlled study.,"The aim of this randomised controlled study was to investigate the effectiveness of mirror therapy (MT) on carpal tunnel syndrome (CTS) patients' symptoms and hand function after surgery. The patients' hand function was evaluated using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Nine Hole Peg Test. Their pain was evaluated using a visual analog scale, and their sensitivity was evaluated using the Semmes-Weinstein monofilament test before surgery, and at 3 and 6 weeks post-surgery. Thirty-five patients between the ages of 25 and 60 years were included in the study. In the control group (CTG) (n=17), the conventional physiotherapy program was applied for 4 weeks after 2 weeks of immobilisation. In addition to conventional physiotherapy, the MT group (MTG) (n=18) did MT during the immobilisation period. There were no statistically significant differences between the groups' demographic and clinical characteristics before treatment (P˃0.05). After treatment, all parameters improved in both groups. MTG had statistically lower pain at rest (P=0.004) and night-time pain (P=0.037) in the 3rd week, but there were no statistically significant differences between the other parameters and scores between the groups (P˃0.05). The study indicates improvement in the parameters due to the early introduction of MT after CTS surgery, but once conventional methods were started after immobilisation, there were no significant differences between groups. However, the MT had reduced pain and improved sensation and function. Both groups experienced positive effects of the surgical treatment and the physiotherapy in the 6th postoperative week.",2020,MTG had statistically lower pain at rest (p=0.004) and nighttime pain (p=0.037) in the 3 rd week.,"[""carpal tunnel syndrome (CTS) patients' symptoms and hand function after surgery"", 'Thirty-five patients between the ages of 25 and 60 years were included in the study', 'carpal tunnel syndrome surgery']","['conventional physiotherapy program', 'mirror therapy (MT', 'mirror therapy', 'conventional physiotherapy, the MT group (MTG']","['pain and improved sensation and function', 'nighttime pain', 'Boston Carpal Tunnel Syndrome Questionnaire (BCTQ', 'pain']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",35.0,0.0252547,MTG had statistically lower pain at rest (p=0.004) and nighttime pain (p=0.037) in the 3 rd week.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Civi Karaaslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece Yerleşkesi Alkent 2000 Mh. Yiğittürk Cd. No:5/9/1 34500 İstanbul, Turkey. Electronic address: tugba.civi@istanbul.edu.tr.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Berkoz', 'Affiliation': 'Hand Surgery Unit, Department of Plastic, Reconstructive and Aesthetic Surgery, Topkapı, Turgut Özal Millet Cd, 34093 Fatih/İstanbul, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece Yerleşkesi Alkent 2000 Mh. Yiğittürk Cd. No:5/9/1 34500 İstanbul, Turkey.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.04.011'] 2487,32574773,Macular and Peripapillary OCTA Metrics Predict Progression in Diabetic Retinopathy: A Sub-analysis of TIME-2b Study Data.,"PURPOSE To identify optical coherence tomography angiography (OCTA) derived vessel metrics of the macula and optic nerve head (ONH) that predict diabetic retinopathy (DR) disease progression. DESIGN Secondary analysis of clinical trial data METHODS: This was a sub-analysis of prospectively collected data from 73 subjects that participated in the TIME-2b Study (Aerpio Pharmaceuticals), a multi-center clinical trial for patients with moderate to severe DR treated with AKB-9778 and followed over a 12-month period. Eligible subjects were tested every 3 months with color fundus photography, spectral domain OCT and slit-lamp biomicroscopy. OCTA of the macula and ONH was obtained for a subset of patients enrolled at participating sites. En-face, full-depth retinal projections centered at the macula were analyzed for multiple metrics including foveal avascular zone (FAZ) area and perimeter, non-perfusion area, vessel density (VD) and presence of intraretinal microvascular abnormalities (IRMA). VD of the radial peripapillary capillaries was evaluated in four quadrants surrounding the optic disc for ONH images. Progression was defined as a ≥ 2-step increase in DR severity scale score or development of diabetic macular edema. RESULTS Over a follow-up period of 12 months, 15 of 73 (20.5%) subjects progressed. At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression. CONCLUSIONS FAZ area and temporal peripapillary VD are predictors of DR progression. OCTA metrics may improve progression risk assessment in DR when compared to established risk factors alone.",2020,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression. ","['Diabetic Retinopathy', '73 subjects that participated in the TIME-2b Study (Aerpio Pharmaceuticals), a multi-center clinical trial for patients with moderate to severe DR treated with AKB-9778 and followed over a 12-month period']","['color fundus photography, spectral domain OCT and slit-lamp biomicroscopy', 'optical coherence tomography angiography (OCTA']","['larger FAZ area, presence of IRMA, and reduced peripapillary VD', 'DR severity scale score or development of diabetic macular edema', 'foveal avascular zone (FAZ) area and perimeter, non-perfusion area, vessel density (VD) and presence of intraretinal microvascular abnormalities (IRMA']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4043862', 'cui_str': 'AKB-9778'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",73.0,0.0248145,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression. ","[{'ForeName': 'Eugenia Custo', 'Initials': 'EC', 'LastName': 'Greig', 'Affiliation': 'New England Eye Center, 260 Tremont Street, Boston, MA; Yale School of Medicine, 333 Cedar St, New Haven, CT.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Brigell', 'Affiliation': 'Aerpio Pharmaceuticals, 9987 Carver Road, Suite 420, Cincinnati, OH.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'New England Eye Center, 260 Tremont Street, Boston, MA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Levine', 'Affiliation': 'New England Eye Center, 260 Tremont Street, Boston, MA; Tufts University School of Medicine, 145 Harrison Ave, Boston, MA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Aerpio Pharmaceuticals, 9987 Carver Road, Suite 420, Cincinnati, OH.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Moult', 'Affiliation': 'Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Fujimoto', 'Affiliation': 'Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, 260 Tremont Street, Boston, MA. Electronic address: nadiakwaheed@gmail.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.009'] 2488,32574801,Emotion generation and regulation following an intrusion induction: Implications for taboo or autogenous obsessions.,"BACKGROUND AND OBJECTIVES Research demonstrates that autogenous (AO) and reactive obsessions (RO) differ in obsessional content; however, no experimental research has examined differences in emotion generation and regulation. Characterizing this taxonomy with respect to emotion generation and regulation could refine conceptualizations of obsessionality and optimize clinical interventions. METHODS Seventy undergraduates were randomly assigned to imagine a personally-relevant AO or RO. Subsequently, emotional reactivity was assessed. Participants then rated their emotion regulation efforts and the degree to which the intrusion violated their values. RESULTS Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion. A conditional process analysis revealed that the relationship between the AO condition and emotion regulation difficulties was explained by an increase in negative emotional reactivity, and the strength of this effect depended upon the degree of conflict with participants' values. LIMITATIONS The use of an analogue sample, and minimal emotional reactivity in the RO condition, threaten the ecological and external validity of the study. CONCLUSIONS The current study employed a novel experimental design demonstrating a meaningful relationship between AOs and both emotional activation and regulation. Results highlight the relevance of self-conscious emotions to the conceptualization of AOs and the utility of addressing them in the context of exposure therapy.",2020,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","['taboo or autogenous obsessions', 'Seventy undergraduates']",['imagine a personally-relevant AO or RO'],"['negative emotional reactivity', 'self-conscious emotions (guilt, shame, and embarrassment', 'AO condition and emotion regulation difficulties', 'emotional reactivity']","[{'cui': 'C0039227', 'cui_str': 'Taboo'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",70.0,0.0314195,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","[{'ForeName': 'Noah Chase', 'Initials': 'NC', 'LastName': 'Berman', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA. Electronic address: nberman@holycross.edu.'}, {'ForeName': 'Jumi', 'Initials': 'J', 'LastName': 'Hayaki', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Szkutak', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101593'] 2489,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children. OBJECTIVES To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers. METHODS 240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months. CONCLUSIONS If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers. ","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers. ","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061'] 2490,32574895,Randomized controlled study comparing tonsillectomy safety and patient satisfaction outcomes between HARMONIC ACE® + shears and monopolar diathermy in an adult population - A pilot study.,"PURPOSE Various types of the harmonic scalpel blades have been used for tonsillectomy since the early 2000s with varying successes. The HARMONIC ACE® + 23 cm shears is a relatively new blade which has not been studied in an adult population yet. METHODOLOGY A randomized controlled pilot study was performed comparing the HARMONIC ACE® + 23 cm shears (HS) and monopolar electrocautery (EC) tonsillectomy in 20 patients. Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes were compared between these two arms. RESULTS The operative time was comparable. Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm. Post-operative pain scores and use of analgesia were similar. There was earlier return to normal diet and activity in the HS arm compared to the EC arm. More patients in the HS arm recommended using HARMONIC ACE® + 23 cm shears compared to those in the EC arm. This is a non-inferiority study which suggests that the HARMONIC ACE® + 23 cm shears is comparable to monopolar electrocautery in terms of efficacy and post-operative complication rates with better patient satisfaction outcomes. The main weakness of the study is a small study population. CONCLUSION This is the first reported study comparing the use of the HARMONIC ACE® + 23 cm shears with monopolar cautery in tonsillectomy. A prospective adequately powered study validated by objective outcome measures would be useful to verify the findings from this pilot study.",2020,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.",['20 patients'],"['ACE®\xa0+\xa0shears and monopolar diathermy', 'harmonic scalpel blades', 'ACE®\xa0+\xa023\xa0cm shears (HS) and monopolar electrocautery (EC) tonsillectomy', 'ACE®\xa0+\xa023\xa0cm shears with monopolar cautery in tonsillectomy']","['Post-operative pain scores and use of analgesia', 'intraoperative bleeding, lower risks of delayed haemorrhage and readmission', 'operative time', 'Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0007471', 'cui_str': 'Cauterization - action'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0502624,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.","[{'ForeName': 'Wei Ming James', 'Initials': 'WMJ', 'LastName': 'Kwek', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu May Celeste Ann', 'Initials': 'SMCA', 'LastName': 'Chua', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu Hui', 'Initials': 'SH', 'LastName': 'Xu', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Toh Hui Leonard', 'Initials': 'THL', 'LastName': 'Tan', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Xin Yong', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Loh', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Tee Sin', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore. Electronic address: lee.tee.sin@singhealth.com.sg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102568'] 2491,32575069,Topical Sodium Bicarbonate: No Improvement in Blood Buffering Capacity or Exercise Performance.,"PURPOSE To assess the efficacy of a topical sodium bicarbonate (0.3 g/kg body weight NaHCO3) application (PR lotion; Amp Human) on blood buffering capacity and performance in recreationally active participants (study A) and moderately trained athletes (study B). METHODS In Study A, 10 participants completed 2 experimental trials: oral NaHCO3 (0.3 g/kg body weight + placebo lotion) or PR lotion (0.9036 g/kg body weight + oral placebo) applied 90 minutes prior to a cycling task to exhaustion (30-s sprints at 120% peak power output with 30-s rest). Capillary blood was collected and analyzed for pH, bicarbonate, and lactate every 10 minutes throughout the 90-minute loading period and postexercise at 5, 10, and 15 minutes. In Study B, 10 cyclists/triathletes completed 2 experimental trials, applying either PR or placebo lotion 30 minutes prior to a cycling performance task (3 × 30-s maximal sprints with 90-s recovery). Capillary blood samples were collected at baseline, preexercise, and postexercise and analyzed as per study A. RESULTS In Study A, pH and bicarbonate were significantly elevated from baseline after 10 minutes in the oral NaHCO3 condition and throughout recovery compared with no elevation in the PR lotion condition (P < .001). No differences in cycling time occurred between PR lotion (349 [119] s) and oral NaHCO3 (363 [80] s; P = .697). In Study B, no differences in blood parameters, mean power (P = .108), or peak power (P = .448) were observed between conditions. CONCLUSIONS PR lotion was ineffective in altering blood buffering capacity or enhancing performance in either trained or untrained individuals.",2020,"In Study B, no differences in blood parameters, mean power (P = .108), or peak power (P = .448) were observed between conditions. ","['recreationally active participants (study A) and moderately trained athletes (study B', '10 cyclists/triathletes completed 2 experimental trials, applying either', '10 participants completed 2 experimental trials']","['PR lotion', 'Topical Sodium Bicarbonate', 'PR or placebo lotion', 'topical sodium bicarbonate (0.3\xa0g/kg body weight NaHCO3) application (PR lotion; Amp Human', 'oral NaHCO3 (0.3\xa0g/kg body weight + placebo lotion) or PR lotion (0.9036\xa0g/kg body weight + oral placebo']","['blood parameters, mean power', 'pH and bicarbonate', 'Capillary blood samples', 'Capillary blood', 'cycling time', 'Blood Buffering Capacity or Exercise Performance']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0560740', 'cui_str': 'g/kg body weight'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0419342', 'cui_str': 'Capillary specimen collection'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",10.0,0.0702487,"In Study B, no differences in blood parameters, mean power (P = .108), or peak power (P = .448) were observed between conditions. ","[{'ForeName': 'Alannah K A', 'Initials': 'AKA', 'LastName': 'McKay', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peeling', 'Affiliation': ''}, {'ForeName': 'Martyn J', 'Initials': 'MJ', 'LastName': 'Binnie', 'Affiliation': ''}, {'ForeName': 'Paul S R', 'Initials': 'PSR', 'LastName': 'Goods', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cross', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Siegler', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0345'] 2492,32575103,"Effectiveness of Aromatherapy for Relief of Pain, Nausea, and Vomiting after Percutaneous Nephrolithotomy: A Randomized Controlled Trial.","BACKGROUND Postoperative pain, nausea, and vomiting are common side effects of percutaneous nephrolithotomy. Nowadays, non-pharmacological and complementary therapies have been noticed. Therefore, a study was conducted to determine the effectiveness of lavender and clary sage on the pain, nausea, and vomiting after percutaneous nephrolithotomy. METHODS This is a randomized clinical trial study on 79 patients undergoing percutaneous nephrolithotomy. Patients were randomly divided into three groups of lavender aromatherapy (n = 27), clary sage aromatherapy (n = 26), and a control group (n = 26). Each of the intervention groups received the inhalation aromatherapy immediately and 3 and 6 h after the operation. Pain, nausea, and emetic episodes in patients of the three groups were measured before the intervention and 30 min after each intervention using a visual analog scale and checklist. RESULTS Pain decreased significantly in the clary sage aromatherapy group. Nausea had a downward trend in the two groups of aromatherapy. The lavender aromatherapy group had the lowest incidence of emetic episodes compared to the other groups. CONCLUSION Regarding the annoying pain, nausea, and vomiting after percutaneous nephrolithotomy for patients, and taking into account the complications of drug therapy, the use of complementary non-pharmacological methods can help increase the comfort of patients.",2020,"The lavender aromatherapy group had the lowest incidence of emetic episodes compared to the other groups. ","['after Percutaneous Nephrolithotomy', '79 patients undergoing']","['lavender aromatherapy', 'Aromatherapy', 'percutaneous nephrolithotomy', 'lavender and clary sage', 'inhalation aromatherapy', 'clary sage aromatherapy']","['pain, nausea, and vomiting', 'Pain, Nausea, and Vomiting', 'Nausea', 'Pain', 'emetic episodes', 'Pain, nausea, and emetic episodes', 'annoying pain, nausea, and vomiting']","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C1337310', 'cui_str': 'Clary sage extract'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",79.0,0.0345045,"The lavender aromatherapy group had the lowest incidence of emetic episodes compared to the other groups. ","[{'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Amirhosseini', 'Affiliation': 'Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, Department of Critical Care Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mangolian Shahrbabaki', 'Affiliation': 'Nursing Research Center, Department of Critical Care Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran, mangolian167@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Pakmanesh', 'Affiliation': 'Department of Urology, Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}]",Complementary medicine research,['10.1159/000508333'] 2493,32575151,Virtual Reality for Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial.,"OBJECTIVE To evaluate the effectiveness of virtual reality as a distraction technique in the management of acute pain and anxiety during outpatient hysteroscopy. DESIGN Parallel group, prospective randomised controlled trial. SETTING UK University Hospital. METHODS Forty consenting, eligible women were randomised to virtual reality intervention (immersive video content as a distraction method) or standard care during outpatient hysteroscopy from August to October 2018. MAIN OUTCOME MEASURES Pain and anxiety outcomes were measured as a numeric rating score (scale of 0-10). RESULTS Compared to standard care, women with virtual reality intervention experienced less average pain (score 6.0 vs. 3.7, mean difference 2.3, 95% CI 0.61-3.99, p=0.009) and anxiety (score 5.45 vs. 3.3, mean difference 2.15, 95% CI 0.38-3.92, p=0.02). CONCLUSION Virtual Reality was effective in reducing pain and anxiety during outpatient hysteroscopy in a mixed-methods randomised control trial. Its wide potential role in ambulatory gynaecologic procedures needs further evaluation.",2020,"Compared to standard care, women with virtual reality intervention experienced less average pain (score 6.0 vs. 3.7, mean difference 2.3, 95% CI 0.61-3.99, p=0.009) and anxiety (score 5.45 vs. 3.3, mean difference 2.15, 95% CI 0.38-3.92, p=0.02). ","['UK University Hospital', 'Forty consenting, eligible women', 'Outpatient Hysteroscopy']","['virtual reality intervention (immersive video content as a distraction method) or standard care', 'virtual reality as a distraction technique', 'Virtual Reality']","['anxiety', 'Pain and anxiety outcomes', 'average pain', 'pain and anxiety', 'numeric rating score (scale of 0-10', 'acute pain and anxiety']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",,0.217682,"Compared to standard care, women with virtual reality intervention experienced less average pain (score 6.0 vs. 3.7, mean difference 2.3, 95% CI 0.61-3.99, p=0.009) and anxiety (score 5.45 vs. 3.3, mean difference 2.15, 95% CI 0.38-3.92, p=0.02). ","[{'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Deo', 'Affiliation': 'Imperial College London, UK.'}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Queen Mary University, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mak', 'Affiliation': 'Queen Mary University, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Allotey', 'Affiliation': 'The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Francisoco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': 'The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Gianpaolo', 'Initials': 'G', 'LastName': 'Fusari', 'Affiliation': 'Helix Centre, Imperial College London and the Royal College of Art, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Benn', 'Affiliation': 'School of Psychology, University of Leeds, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16377'] 2494,32575350,Merit of an Ursodeoxycholic Acid Clinical Trial in COVID-19 Patients.,"Corona Virus Disease 2019 (COVID-19) has affected over 8 million people worldwide. We underscore the potential benefits of conducting a randomized open-label unblinded clinical trial to evaluate the role of ursodeoxycholic acid (UDCA) in the treatment of COVID-19. Some COVID-19 patients are characterized with cytokine storm syndrome that can cause severe and irreversible damage to organs leading to multi-organ failure and death. Therefore, it is critical to control both programmed cell death (apoptosis) and the hyper-immune inflammatory response in COVID-19 patients to reduce the rising morbidity and mortality. UDCA is an existing drug with proven safety profiles that can reduce inflammation and prevent cell death. National Geographic reported that, ""China Promotes Bear Bile as Coronavirus Treatment"". Bear bile is rich in UDCA, comprising up to 40-50% of the total bile acid. UDCA is a logical and attainable replacement for bear bile that is available in pill form and merits clinical trial consideration.",2020,Corona Virus Disease 2019 (COVID-19) has affected over 8 million people worldwide.,['COVID-19 Patients'],"['Ursodeoxycholic Acid', 'ursodeoxycholic acid (UDCA', 'UDCA']",[],"[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}]",[],,0.0492605,Corona Virus Disease 2019 (COVID-19) has affected over 8 million people worldwide.,"[{'ForeName': 'Subbaya', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Tinen', 'Initials': 'T', 'LastName': 'Iles', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Sayeed', 'Initials': 'S', 'LastName': 'Ikramuddin', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Clifford J', 'Initials': 'CJ', 'LastName': 'Steer', 'Affiliation': 'Departments of Medicine and Genetics, Cell Biology and Development, University of Minnesota, Minneapolis, MN 55455, USA.'}]",Vaccines,['10.3390/vaccines8020320'] 2495,32575480,"Pain Bloc-R Alleviates Unresolved, Non-Pathological Aches and Discomfort in Healthy Adults-A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.","The lack of effective treatment for chronic discomfort without negative side effects highlights the need for alternative treatments. Pain Bloc-R is a natural health product composed of vitamins B 6 , B 12 , D, white willow bark extract, Angelica root extract, acetyl L-carnitine HCl, caffeine, L-theanine, Benfotiamine, and L-tetrahydropalmatine. The objective of this study was to compare the effects of Pain Bloc-R, acetaminophen, and placebo on unresolved aches and discomfort as assessed by the brief pain inventory (BPI) and modified Cornell musculoskeletal discomfort questionnaires. This randomized, double-blind, placebo-controlled, crossover study consisted of three 7-day periods with Pain Bloc-R, acetaminophen, or placebo, each separated by a 7-day washout. Twenty-seven healthy adults (ages 22-63 years) were randomized to receive the three interventions in different sequences. The BPI ""pain at its worst"" scores were significantly lower when participants took Pain Bloc-R than when they took acetaminophen (21.8% vs. 9.8% decrease, p = 0.026) after seven days of supplementation. Pain Bloc-R achieved a significant improvement in the ""pain at its least"" score, significantly decreased the interference of discomfort in walking, and significantly decreased musculoskeletal discomfort total scores (34%, p = 0.040) after seven days. In a post hoc subgroup analysis based on age and gender, male participants ≤45 years taking Pain Bloc-R reported significant reductions in pain severity and pain interference vs. acetaminophen. Pain Bloc-R performed as well as acetaminophen in managing unresolved non-pathological pain in otherwise healthy individuals.",2020,Pain Bloc-R performed as well as acetaminophen in managing unresolved non-pathological pain in otherwise healthy individuals.,"['otherwise healthy individuals', 'Healthy Adults', 'Twenty-seven healthy adults (ages 22-63 years']","['Pain Bloc-R, acetaminophen, and placebo', 'Placebo', 'Pain Bloc-R, acetaminophen, or placebo', 'acetaminophen', 'placebo']","['Pain Bloc-R', 'brief pain inventory (BPI) and modified Cornell musculoskeletal discomfort questionnaires', 'interference of discomfort in walking', 'BPI ""pain', 'pain severity and pain interference vs. acetaminophen', 'pain', 'musculoskeletal discomfort total scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",27.0,0.501716,Pain Bloc-R performed as well as acetaminophen in managing unresolved non-pathological pain in otherwise healthy individuals.,"[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'Abdul M', 'Initials': 'AM', 'LastName': 'Sulley', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Crowley', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Langston', 'Affiliation': 'LifeSeasons, Inc., Springville, UT 84663, USA.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Guthrie', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}]",Nutrients,['10.3390/nu12061831'] 2496,32575482,Randomised Controlled Feasibility Study of the MyHealthAvatar-Diabetes Smartphone App for Reducing Prolonged Sitting Time in Type 2 Diabetes Mellitus.,"This study evaluated the feasibility and acceptability of a self-regulation smartphone app for reducing prolonged sitting in people with Type 2 diabetes mellitus (T2DM). This was a two-arm, randomised, controlled feasibility trial. The intervention group used the MyHealthAvatar-Diabetes smartphone app for 8 weeks. The app uses a number of behaviour change techniques aimed at reducing and breaking up sitting time. Eligibility, recruitment, retention, and completion rates for the outcomes (sitting, standing, stepping, and health-related measures) assessed trial feasibility. Interviews with participants explored intervention acceptability. Participants with T2DM were randomised to the control ( n = 10) and intervention groups ( n = 10). Recruitment and retention rates were 71% and 90%, respectively. The remaining participants provided 100% of data for the study measures. The MyHealthAvatar-Diabetes app was viewed as acceptable for reducing and breaking up sitting time. There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group. In conclusion, the findings indicate that it would be feasible to deliver and evaluate the efficacy of the MyHealthAvatar-Diabetes app for breaking up sitting time and improving health outcomes in a full trial.",2020,"There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group.","['Participants with T2DM', 'Type 2 Diabetes Mellitus', 'people with Type 2 diabetes mellitus (T2DM']","['MyHealthAvatar-Diabetes smartphone', 'self-regulation smartphone app', 'MyHealthAvatar-Diabetes Smartphone App']","['number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect', 'Recruitment and retention rates', 'Eligibility, recruitment, retention, and completion rates for the outcomes (sitting, standing, stepping, and health-related measures) assessed trial feasibility', 'health outcomes', 'Prolonged Sitting Time']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0445131', 'cui_str': 'Number of breaks'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0458148,"There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group.","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Bailey', 'Affiliation': 'Division of Sport, Health and Exercise Sciences, Department of Life Sciences, Brunel University London, Kingston Lane, Uxbridge UB8 3PH, UK.'}, {'ForeName': 'Lucie H', 'Initials': 'LH', 'LastName': 'Mugridge', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Polhill Avenue, Bedford MK41 9EA, UK.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Department of Computer and Information Sciences, University of Strathclyde, Glasgow G1 1XH, UK.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute for Research in Applicable Computing, University of Bedfordshire, Luton LU1 3JU, UK.'}, {'ForeName': 'Angel M', 'Initials': 'AM', 'LastName': 'Chater', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Polhill Avenue, Bedford MK41 9EA, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17124414'] 2497,32575605,Palatable Noodles as a Functional Staple Food Made Exclusively from Yellow Peas Suppressed Rapid Postprandial Glucose Increase.,"Legumes are low-carbohydrate food and are abundant in dietary fiber. In order to provide a functional staple food that does not cause a rapid increase in postprandial blood glucose levels, four kinds of legumes were focused on as ingredients. Noodles made from dehulled yellow pea, unshelled yellow pea, chickpea, and lentil were prepared and evaluated as functional staple foods for controlling blood glucose via an in vitro digestion method. We also measured breaking stress and breaking strain using a creep meter, as well as sensory tests on a 9-point hedonic scale. The noodles made from yellow pea had high values for both breaking stress and breaking strain, and was highly regarded in the sensory tests. Therefore, the noodles made from yellow pea on postprandial glucose and insulin response were measured in a randomized double-blind study ( n = 12). The results show that noodles made from yellow pea have a low glycemic index (50.4), and have potential as a functional staple food.",2020,"The noodles made from yellow pea had high values for both breaking stress and breaking strain, and was highly regarded in the sensory tests.",[],[],"['postprandial blood glucose levels', 'postprandial glucose and insulin response']",[],[],"[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.0287479,"The noodles made from yellow pea had high values for both breaking stress and breaking strain, and was highly regarded in the sensory tests.","[{'ForeName': 'Joto', 'Initials': 'J', 'LastName': 'Yoshimoto', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Ban', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Mikiya', 'Initials': 'M', 'LastName': 'Kishi', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd. 2-6 Nakamura-Cho, Handa-Shi, Aichi 475-8585, Japan.'}, {'ForeName': 'Humitoshi', 'Initials': 'H', 'LastName': 'Horie', 'Affiliation': 'Public Interest Incorporated Foundation Aiseikai Aisei Hospital Ueno Clinic, 2-18-6, Higashi-Ueno, Taito-Ku, Tokyo 100-0015, Japan.'}, {'ForeName': 'Chizumi', 'Initials': 'C', 'LastName': 'Yamada', 'Affiliation': 'Department of Clinical Health Science, Tokai University School of Medicine Tokai University Tokyo Hospital, 1-2-5 Yoyogi, Shibuya-ku, Tokyo 153-0065, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishizaki', 'Affiliation': 'Department of Clinical Health Science, Tokai University School of Medicine Tokai University Tokyo Hospital, 1-2-5 Yoyogi, Shibuya-ku, Tokyo 153-0065, Japan.'}]",Nutrients,['10.3390/nu12061839'] 2498,32575611,"Effect of a Flaxseed Lignan Intervention on Circulating Bile Acids in a Placebo-Controlled Randomized, Crossover Trial.","Plant lignans and their microbial metabolites, e.g., enterolactone (ENL), may affect bile acid (BA) metabolism through interaction with hepatic receptors. We evaluated the effects of a flaxseed lignan extract (50 mg/day secoisolariciresinol diglucoside) compared to a placebo for 60 days each on plasma BA concentrations in 46 healthy men and women (20-45 years) using samples from a completed randomized, crossover intervention. Twenty BA species were measured in fasting plasma using LC-MS. ENL was measured in 24-h urines by GC-MS. We tested for (a) effects of the intervention on BA concentrations overall and stratified by ENL excretion; and (b) cross-sectional associations between plasma BA and ENL. We also explored the overlap in bacterial metabolism at the genus level and conducted in vitro anaerobic incubations of stool with lignan substrate to identify genes that are enriched in response to lignan metabolism. There were no intervention effects, overall or stratified by ENL at FDR < 0.05. In the cross-sectional analysis, irrespective of treatment, five secondary BAs were associated with ENL excretion (FDR < 0.05). In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases. These data suggest overlap in community bacterial metabolism of secondary BA and ENL.",2020,In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases.,['46 healthy men and women (20-45 years) using samples'],"['flaxseed lignan extract (50 mg/day secoisolariciresinol diglucoside', 'Flaxseed Lignan Intervention', 'placebo']","['fasting plasma using LC-MS', 'Circulating Bile Acids', 'BA concentrations overall and stratified by ENL excretion; and (b) cross-sectional associations between plasma BA and ENL', 'plasma BA concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0045341', 'cui_str': ""2,3-bis(3'-hydroxybenzyl)butyrolactone""}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",46.0,0.0675738,In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases.,"[{'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Curtis', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Elkon', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Orsalem J', 'Initials': 'OJ', 'LastName': 'Kahsai', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Hamza S', 'Initials': 'HS', 'LastName': 'Ammar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Natalie N', 'Initials': 'NN', 'LastName': 'Hong', 'Affiliation': 'Northwest Metabolomics Research Center, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA 98109, USA.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Carnevale Neto', 'Affiliation': 'Northwest Metabolomics Research Center, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA 98109, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Chapkin', 'Affiliation': 'Program in Integrative Nutrition & Complex Diseases, Texas A&M University, College Station, TX 77843, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Meredith A J', 'Initials': 'MAJ', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}]",Nutrients,['10.3390/nu12061837'] 2499,32575660,"Parent Stress as a Consideration in Childhood Obesity Prevention: Results from the Guelph Family Health Study, a Pilot Randomized Controlled Trial.","Parents' stress is independently associated with increased child adiposity, but parents' stress may also interfere with childhood obesity prevention programs. The disruptions to the family dynamic caused by participating in a behaviour change intervention may exacerbate parent stress and undermine overall intervention efficacy. This study explored how family stress levels were impacted by participation in a home-based obesity prevention intervention. Data were collected from 77 families (56 fathers, 77 mothers) participating in the Guelph Family Health Study (GFHS), a pilot randomized control trial of a home-based obesity prevention intervention. Four measures of stress were investigated: general life stress, parenting distress, depressive symptoms, and household chaos. Multiple linear regression was used to compare the level of stress between the intervention and control groups at post-intervention and 1-year follow-up, adjusted for baseline stress. Analyses for mothers and fathers were stratified, except for household chaos which was measured at the family level. Results indicate no significant differences between intervention and control groups for any stress measure at any time point, indicating a neutral effect of the GFHS intervention on family stress. Future work should investigate the components of family-based intervention protocols that make participation minimally burdensome and consider embedding specific stress-reduction messaging to promote family health and wellbeing.",2020,"Results indicate no significant differences between intervention and control groups for any stress measure at any time point, indicating a neutral effect of the GFHS intervention on family stress.","['77 families (56 fathers, 77 mothers) participating in the Guelph Family Health Study (GFHS', 'mothers and fathers']","['home-based obesity prevention intervention', 'GFHS intervention']","['general life stress, parenting distress, depressive symptoms, and household chaos', 'child adiposity']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",77.0,0.0183439,"Results indicate no significant differences between intervention and control groups for any stress measure at any time point, indicating a neutral effect of the GFHS intervention on family stress.","[{'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hruska', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON N1G2W1, Canada.'}, {'ForeName': 'Gerarda', 'Initials': 'G', 'LastName': 'Darlington', 'Affiliation': 'Department of Mathematics and Statistics, University of Guelph, Guelph, ON N1G2W1, Canada.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Haines', 'Affiliation': 'Department of Family Relations and Applied Nutrition, University of Guelph, Guelph, ON N1G2W1, Canada.'}, {'ForeName': 'David W L', 'Initials': 'DWL', 'LastName': 'Ma', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON N1G2W1, Canada.'}]",Nutrients,['10.3390/nu12061835'] 2500,32575945,[Therapeutic effects of target artery infusion of verapamil and chemotherapy drugs on advanced non-small cell lung cancer].,"Objective: To investigate the effects of targeted artery perfusion of verapamil and chemotherapy drugs on advanced non-small cell lung cancer (NSCLC). Methods: Sixty patients with advanced NSCLC who were admitted to the Central Hospital of Zhumadian from April 2016 to April 2018 were selected as the research subjects. They were divided into the observation group (26 cases) and the control group (34 cases) according to the treatment method. Patients in the observation group were treated with targeted artery perfusion of verapamil and chemotherapy drugs while the control group were treated with target artery perfusion of chemotherapy drugs alone.Both groups were treated continuously for more than 2 months. The short-term curative effect, adverse reactions, changes in immune function, levels of serum tumor markers and Karnofsky Performance Scale (KPS) scores before and after treatment as well as the prognosis were compared between the two groups. Results: The response rate and control rate in the observation group were 80.8% and 96.2%, higher than 55.9% and 76.5% in the control group ( P <0.05). After treatment, CD4(+) levels and CD4(+) /CD8(+) in the observation group were (25.43±2.76)% and (0.88±0.11), lower than (27.56±2.79)% and (0.95±0.13) in the control group ( P <0.05). After treatment, serum levels of CEA and CA50 in the observation group were (11.57±2.32)ng/ml and (16.62±3.28)U/ml, also lower than (15.87±2.66)ng/ml and (20.31±3.42)U/ml in the control group ( P <0.05). There was no significant difference in adverse reactions between the two groups ( P >0.05). After treatment, KPS score of the observation group was (81.44±2.76) points, higher than (79.62±2.38) points of the control group ( P <0.05). The median survival time and progression-free median survival time of the observation group were 16.0 months and 7.5 months, respectively, significantly better than 10.0 months and 5.0 months of the control group ( P <0.05). Conclusions: The treatment with target arterial perfusion of verapamil and chemotherapy drugs for advanced NSCLC can effectively improve the short-term curative effect, reduce serum levels of tumor markers, improve life quality and prolong the survival time. However, it has a certain inhibitory effect on the patient's immune function.",2020,"After treatment, KPS score of the observation group was (81.44±2.76) points, higher than (79.62±2.38) points of the control group ( P <0.05).","['advanced non-small cell lung cancer', 'advanced non-small cell lung cancer (NSCLC', 'Sixty patients with advanced NSCLC who were admitted to the Central Hospital of Zhumadian from April 2016 to April 2018 were selected as the research subjects']","['CD8', 'target artery perfusion of chemotherapy drugs alone', 'verapamil', 'verapamil and chemotherapy drugs']","['KPS score', 'serum levels of CEA and CA50', 'survival time', 'short-term curative effect, adverse reactions, changes in immune function, levels of serum tumor markers and Karnofsky Performance Scale (KPS) scores', 'response rate and control rate', 'adverse reactions', 'life quality', 'median survival time and progression-free median survival time', 'CD4(+) levels and CD4']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}]","[{'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}]",60.0,0.0308044,"After treatment, KPS score of the observation group was (81.44±2.76) points, higher than (79.62±2.38) points of the control group ( P <0.05).","[{'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Tan', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Ma', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, Central Hospital of Zhumadian, Zhumadian 463000, China.'}]",Zhonghua zhong liu za zhi [Chinese journal of oncology],['10.3760/cma.j.cn112152-20190724-00461'] 2501,32575977,Effects of Olfactory Training in Patients With Postinfectious Olfactory Dysfunction.,"Objectives Postinfectious olfactory dysfunction (PIOD) is the most common etiology of olfactory dysfunction, and olfactory training (OT) is an accepted treatment modality for PIOD. Some studies have investigated OT in Korean patients, but they involved odorants unfamiliar to Koreans or had no control group. The aim of this study was to verify the efficacy of OT in PIOD patients, using odorants familiar to Koreans and including a control group. Methods We enrolled a total of 104 Korean patients with PIOD over the 3-year study period. All participants were assessed using endoscopy and an olfactory function test at the baseline assessment and 3 months after OT. The olfactory function test was performed using the Korean version of Sniffin' stick (KVSS) II. Nasal and psychological function was evaluated using a visual analog scale and the Mini-Mental State Examination. OT was performed over a period of 3 months, using five odorants (rose, lemon, cinnamon, orange, and peach). Results OT improved olfactory function in approximately 40% of subjects over a period of 12 weeks compared to non-OT subjects. A comparison of changes between the initial and follow-up assessments demonstrated that the OT group had significantly better olfactory results for the total KVSS II, threshold, and identification scores than the non-OT group. The degree of olfactory improvement after OT was affected by the initial score. Conclusion The effects of OT in patients with PIOD were demonstrated in this study. A meaningful contribution of this study is that Korean patients were tested using odors familiar to them in comparison with a control group.",2020,"Results OT improved olfactory function in approximately 40% of subjects over a period of 12 weeks compared to non-OT subjects.","['104 Korean patients with PIOD over the 3-year study period', 'PIOD patients, using odorants familiar to Koreans and including a control group', 'Patients With Postinfectious Olfactory Dysfunction', 'patients with PIOD', 'Korean patients']","['OT', 'Olfactory Training']","['Nasal and psychological function', 'olfactory function', 'degree of olfactory improvement after OT', 'visual analog scale and the Mini-Mental State Examination']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2985522', 'cui_str': 'Odorants'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]",104.0,0.022602,"Results OT improved olfactory function in approximately 40% of subjects over a period of 12 weeks compared to non-OT subjects.","[{'ForeName': 'Bo Yoon', 'Initials': 'BY', 'LastName': 'Choi', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hamin', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Haemin', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joon Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Kook', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}]",Clinical and experimental otorhinolaryngology,['10.21053/ceo.2020.00143'] 2502,32576004,Application of an education model using the WeChat public platform in the standardized training of anesthesiology residents.,"BACKGROUND Standardized training of clinical residents is an important way to train high-level clinicians and is an important step to ensure quality clinical work. WeChat facilitates efficient information dissemination and feedback, convenient communication. In the new media era, the influence of WeChat has inspired changes in educational methods, to explore the role of an education model using the WeChat public platform in the standardized training of anesthesiology residents. METHODS A total of 40 anesthesiology residents undergoing standardized training in our department from January 2016 to August 2017 were selected as subjects and randomly divided into 2 groups: traditional group (n=20) and WeChat group (n=20). In the WeChat group, in addition to the traditional clinical teaching model (lectures), the residents also received push information from the WeChat public platform for anesthesia education. The residents in the traditional group did not receive the push information and only received traditional clinical teaching. Three months later, assessment scores of and teaching quality in the 2 groups were evaluated. Teaching quality was evaluated using peer assessment and self-assessment questionnaires. RESULTS Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05). The questionnaire results indicated that the degree of satisfaction of the residents and teachers in the WeChat group was significantly higher than that in the traditional group (P<0.05). The theoretical knowledge scores, operational skill scores and overall scores in the WeChat group were significantly higher than those in the traditional group (P<0.05). CONCLUSIONS Applying an education model based on the WeChat public platform in standardized training of anesthesiology residents can significantly improve teaching efficacy and satisfaction, enhance comprehensive assessment results, and improve teaching quality.",2020,"RESULTS Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05).","['40 anesthesiology residents undergoing standardized training in our department from January 2016 to August 2017', 'anesthesiology residents']","['push information and only received traditional clinical teaching', 'WeChat']","['teaching quality', 'theoretical knowledge scores, operational skill scores and overall scores', 'Teaching quality', 'teaching efficacy and satisfaction', 'assessment scores of and teaching quality', 'theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English']","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",,0.0113754,"RESULTS Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shiwei', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, China. lijinbaoshanghai@163.com.'}]",Annals of palliative medicine,['10.21037/apm-19-390'] 2503,32576042,SHORT-TERM VERSUS 6-WEEK PREDNISONE IN THE TREATMENT OF SUBACUTE THYROIDITIS: A RANDOMIZED CONTROLLED TRIAL.,"Objective : Moderate-to-severe subacute thyroiditis is clinically managed with 6-8 weeks of glucocorticoid therapy. However, no studies have evaluated short-term prednisone treatment for subacute thyroiditis. Methods : This 24-week, prospective, single-blind, randomized controlled study enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014. Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/d prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy. The primary endpoint was intergroup differences in treatment efficacy at the end of treatment course. Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6, 12, and 24. Results : We screened 96 patients, randomized 52 participants, and 50 completed the study. Efficacy and recurrence rates were not significantly different at withdrawal in both groups ( P=0.65 ). At treatment discontinuation, parathyroid hormone (28.8 vs 38.9 pg/mL, p=0.011 ) and systolic blood pressure (113.9 vs 122.4 mmHg, p=0.023 ) were significantly lower in the experimental group than in the control group. There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24. Conclusions : Fewer side effects of glucocorticoids and similar efficacy and recurrence rates were observed with short-term prednisone compared with in the 6-week treatment for subacute thyroiditis. Short-term prednisone with a better safety profile may be an alternative strategy for ameliorating moderate-to-severe symptoms of subacute thyroiditis.",2020,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24. ","['Patients with moderate-to-severe symptoms', '96 patients, randomized 52 participants, and 50 completed the study', 'enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014']","['30 mg/d prednisone', 'prednisone', 'nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy', 'glucocorticoid therapy', 'glucocorticoids']","['Efficacy and recurrence rates', 'treatment efficacy', 'post-withdrawal adverse effect parameters and thyroid function', 'systolic blood pressure', 'efficacy and recurrence rates', 'parathyroid hormone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040149', 'cui_str': 'Subacute thyroiditis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",52.0,0.0775229,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24. ","[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'From: Department of Endocrinology, The Third Affiliated Hospital of Chongqing Medical University (Jie er Hospital), Chongqing, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rufei', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0096'] 2504,32444540,Tolcapone Treatment for Cognitive and Behavioral Symptoms in Behavioral Variant Frontotemporal Dementia: A Placebo-Controlled Crossover Study.,"BACKGROUND There are currently no disease-targeted treatments for cognitive or behavioral symptoms in patients with behavioral variant frontotemporal dementia (bvFTD). OBJECTIVE To determine the effect of tolcapone, a specific inhibitor of Catechol-O-Methyltransferase (COMT), in patients with bvFTD. METHODS In this randomized, double-blind, placebo-controlled, cross-over study at two study sites, we examined the effect of tolcapone on 28 adult outpatients with bvFTD. The primary outcome was reaction time on the N-back cognitive test. As an imaging outcome, we examined differences in the resting blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) signal intensity between subjects on placebo versus tolcapone performing the N-back test. Secondary outcomes included measures of cognitive performance and behavioral disturbance using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Neuropsychiatric Inventory-Questionnaire (NPI-Q), and Clinical Global Impressions scale (CGI). RESULTS Tolcapone was well tolerated and no patients dropped out. The most frequent treatment-related adverse event during tolcapone treatment was elevated liver enzymes (21%). There were no significant differences between tolcapone treatment and placebo in the primary or imaging outcomes. However, there were significant differences between RBANS total scores (p < 0.01), NPI-Q total scores (p = 0.04), and CGI total scores (p = 0.035) between treatment conditions which were driven by differences between baseline and tolcapone conditions. Further, there was a trend toward significance between tolcapone and placebo on the CGI (p = 0.078). CONCLUSIONS Further study of COMT inhibition and related approaches with longer duration of treatment and larger sample sizes in frontotemporal lobar degeneration-spectrum disorders may be warranted.",2020,"However, there were significant differences between RBANS total scores (p < 0.01), NPI-Q total scores (p = 0.04), and CGI total scores (p = 0.035) between treatment conditions which were driven by differences between baseline and tolcapone conditions.","['patients with behavioral variant frontotemporal dementia (bvFTD', 'Behavioral Variant Frontotemporal Dementia', 'patients with bvFTD', '28 adult outpatients with bvFTD']","['Tolcapone', 'Placebo', 'tolcapone and placebo', 'placebo versus tolcapone', 'tolcapone, a specific inhibitor of Catechol-O-Methyltransferase (COMT', 'tolcapone', 'placebo']","['Cognitive and Behavioral Symptoms', 'tolerated', 'RBANS total scores', 'NPI-Q total scores', 'reaction time on the N-back cognitive test', 'cognitive performance and behavioral disturbance using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Neuropsychiatric Inventory-Questionnaire (NPI-Q), and Clinical Global Impressions scale (CGI', 'CGI total scores', 'resting blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) signal intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}]","[{'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",28.0,0.476147,"However, there were significant differences between RBANS total scores (p < 0.01), NPI-Q total scores (p = 0.04), and CGI total scores (p = 0.035) between treatment conditions which were driven by differences between baseline and tolcapone conditions.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fremont', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Manoochehri', 'Affiliation': 'Taub Institute, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Armstrong', 'Affiliation': 'Laboratory of Behavioral Neuroscience, NIA/NIH, Bethesda, MD, USA.'}, {'ForeName': 'Venkata S', 'Initials': 'VS', 'LastName': 'Mattay', 'Affiliation': 'Lieber Institute for Brain Development, Johns Hopkins Medical Campus, Baltimore, MD, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Apud', 'Affiliation': 'Section on Integrative Neuroimaging, Clinical & Translational Neuroscience Branch, Intramural Research Program, NIMH/NIH, Bethesda, MD, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Tierney', 'Affiliation': 'Behavioral Neurology Unit, Intramural Research Program, NINDS/NIH, Bethesda, MD, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Yunglin', 'Initials': 'Y', 'LastName': 'Gazes', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Habeck', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Wassermann', 'Affiliation': 'Behavioral Neurology Unit, Intramural Research Program, NINDS/NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Grafman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cognitive Neuroscience Laboratory, Brain Injury Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Huey', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191265'] 2505,32445184,Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program.,"INTRODUCTION Etrolizumab is a next-generation anti-integrin with dual action that targets two pathways of inflammation in the gut. A robust phase 3 clinical program in ulcerative colitis (UC) and Crohn's disease is ongoing and will evaluate the efficacy and safety of etrolizumab in well-defined patient populations in rigorous trials that include direct head-to-head comparisons against approved anti-tumor necrosis factor alpha agents (anti-TNF). The etrolizumab phase 3 clinical program consists of six randomized controlled trials (RCTs; UC: HIBISCUS I and II, GARDENIA, LAUREL, HICKORY; Crohn's disease: BERGAMOT) and two open-label extension trials (OLEs; UC: COTTONWOOD; Crohn's disease: JUNIPER) evaluating patients with moderately to severely active UC or Crohn's disease. METHODS In the UC RCTs, patients are randomly assigned according to each protocol to receive etrolizumab, adalimumab, infliximab, or placebo. In BERGAMOT, patients are randomly assigned to receive etrolizumab 105 mg, etrolizumab 210 mg, or placebo. The primary outcomes for the UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease). The OLEs will primarily assess long-term efficacy and safety. Secondary and exploratory endpoints include endoscopy, histology, quality of life, and biomarkers at various timepoints. DISCUSSION The etrolizumab phase 3 clinical program is the largest and most comprehensive in inflammatory bowel disease, enrolling more than 3000 patients. The program explores both induction and maintenance regimens. HIBISCUS I and II and GARDENIA are among the first head-to-head trials in UC against an anti-TNF and are the first registrational trials making that comparison. This program will also help address unanswered clinical questions on evaluation of treatment effects and treatment selection across a range of patients with varying treatment histories using an extensive repository of patient samples and data. TRIAL REGISTRATION ClinicalTrials.gov: HIBISCUS I (NCT02163759), HIBISCUS II (NCT02171429), GARDENIA (NCT02136069), LAUREL (NCT02165215), HICKORY (NCT02100696), COTTONWOOD (NCT02118584), BERGAMOT (NCT02394028), JUNIPER (NCT02403323).",2020,HIBISCUS ,"['3000 patients', ""Ulcerative Colitis and Crohn's Disease"", ""patients with moderately to severely active UC or Crohn's disease""]","['Etrolizumab', 'etrolizumab, adalimumab, infliximab, or placebo', 'etrolizumab 105\xa0mg, etrolizumab 210\xa0mg, or placebo', 'etrolizumab']","[""UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease"", 'endoscopy, histology, quality of life, and biomarkers at various timepoints']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.181287,HIBISCUS ,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrrell', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lacey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Tole', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Tatro', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland. amanda.tatro@roche.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01366-2'] 2506,32576049,MENSTRUAL DISORDERS AND ANDROGEN-RELATED TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS: A CLINICAL STUDY.,"Objective. To investigate possible causes of menstrual disorders and androgen-related traits in young women with T1DM. Patients and Methods. Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited. Results. Two women (3.8%) in the T1DM group had not experienced menarche (at 15.5 and 16.6 years); of the rest, 23.5% had oligomenorrhea, 32.1% hirsutism, 45.3% acne. The age at menarche was delayed in the T1DM group compared to controls (12.7±1.3 vs. 12.0±1.0 years, p=0.004), while no difference was observed with the PCOS group (12.4±1.2 years). There were no differences in total testosterone (0.43±0.14 vs. 0.39±0.14 ng/ml, p>0.05), DHEA-S (269±112 vs. 238±106 μg/dl, p>0.05) or Δ4-androstenedione (2.4±1.3 vs. 1.9±0.5 ng/ml, p>0.05) concentrations between T1DM and controls. However, patients with T1DM had lower SHBG concentrations than controls (61±17 vs. 83±18.1 nmol/l, p=0.001), which were even lower in the PCOS group (39.5±12.9 nmol/, p=0.001 compared with T1DM). FAI (free androgen index) was higher in the PCOS group compared with both other groups (T1DM vs. PCOS vs. controls: 2.53±0.54 vs 7.88±1.21 vs. 1.6±0.68, p<0.001). FAI was higher in patients with T1DM compared to controls, too (p=0.038). There was no difference in DHEA-S concentrations between T1DM and PCOS patients (269±112 vs. 297±100 μg/dl, p>0.05). Conclusions. Menstrual disorders and androgen-related traits in young women with T1DM may be attributed to an increase in androgen bioavailability due to decreased SHBG concentrations.",2020,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","['TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS', 'Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited', 'young women with T1DM']",[],"['lower SHBG concentrations', 'FAI (free androgen index', 'total testosterone', 'DHEA-S concentrations', 'FAI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}]",53.0,0.0903609,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","[{'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andromachi', 'Initials': 'A', 'LastName': 'Vryonidou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Melissourgou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosteria', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios G', 'Initials': 'DG', 'LastName': 'Goulis', 'Affiliation': 'Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kanaka-Gantenbein', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0153'] 2507,32576090,Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke: Proof-of-Concept Randomized Controlled Trial.,"BACKGROUND AND PURPOSE Disabling anxiety affects a quarter of stroke survivors but access to treatment is poor. We developed a telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT) for anxiety after stroke (TASK-CBT). We aimed to evaluate the feasibility of TASK-CBT in a randomized controlled trial workflow that enabled all trial procedures to be carried out remotely. In addition, we explored the feasibility of wrist-worn actigraphy sensor as a way of measuring objective outcomes in this clinical trial. METHODS We recruited adult community-based stroke patients (n=27) and randomly allocated them to TASK-CBT (n=14) or relaxation therapy (TASK-Relax), an active comparator (n=13). RESULTS In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible. All participants completed all TASK-CBT sessions (14/14). Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20. Mean actigraphy sensor wearing-time was 33 days (±15). CONCLUSIONS Our preliminary feasibility data from the current study support a larger definitive clinical trial and the use of wrist-worn actigraphy sensor in anxious stroke survivors. REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT03439813.",2020,Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20.,"['anxious stroke survivors', 'In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible', 'adult community-based stroke patients (n=27']","['telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT', 'Telemedicine Cognitive Behavioral Therapy', 'TASK-CBT', 'relaxation therapy (TASK-Relax), an active comparator (n=13', 'wrist-worn actigraphy sensor']","['Mean actigraphy sensor wearing-time', 'Lower levels of anxiety', 'Anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.157782,Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20.,"[{'ForeName': 'Ho-Yan Yvonne', 'Initials': 'HY', 'LastName': 'Chun', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.).'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Carson', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.).'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsanas', 'Affiliation': 'Centre for Medical Informatics, Usher Institute, University of Edinburgh, UK. (A.T.).'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.).'}, {'ForeName': 'Gillian E', 'Initials': 'GE', 'LastName': 'Mead', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.).'}, {'ForeName': 'Clementina', 'Initials': 'C', 'LastName': 'Calabria', 'Affiliation': 'Royal Infirmary of Edinburgh, National Health Service Lothian, Edinburgh, UK. (C.C.).'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Whiteley', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.).'}]",Stroke,['10.1161/STROKEAHA.120.029042'] 2508,32576131,Remifentanil with or without Propofol as Anesthesia Agents for Trans-Vaginal Ultrasonography Oocyte Retrieval (TUGOR) on Pregnancy and Anesthesia Outcomes: A Randomized Controlled Trial.,"BACKGROUND Transvaginal Ultrasound-Guided Oocyte Retrieval (TUGOR) is a painful procedure, which often requires the application of anesthesia agents. There is a controversy in the literature about the effects of administrated anesthetics for TUGOR on patients & pregnancy outcomes. OBJECTIVE The current study aimed to compare the effects of remifentanil with or without propofol, administrated for TUGOR, on pregnancy and anesthesia outcomes. METHOD In a double-blind randomized controlled trial, 180 candidates of TUGOR, aged 18-40 years old, were included in the study. All study women received midazolam 0.03 mg/kg and remifentanil 1 ug/kg as anesthesia induction; Later on, they were randomly assigned in two equal size groups in term of anesthesia maintenance, as the intervention group received remifentanil infusion 0.25 μg/kg/min and the control group received remifentanil infusion 1ug/kg/min with propofol 50-150 ug/kg/min. Hemodynamic symptoms, operation outcomes including the side effects, and pregnancy outcomes were compared between the study groups. The study is registered with the Iranian Clinical Trials Registry, number IRCT201611177013N15. RESULTS Although the hemodynamic symptoms showed significantly better ranges in remifentanil group, however, the study groups were not significantly different in durations of operation, anesthesia and recovery. However, the anesthesia side effects during and after the operation were not significantly different between the groups, they were more common in the control one. The reproductive outcomes (numbers of collected oocytes, fertilized oocytes and transferred embryos, pregnancy rates) showed better but non-significant ranges in remifentanil group. CONCLUSION Using remifentanil alone in comparison to remifentanil & propofol in TUGOR procedure can be achieved better pregnancy outcomes without imposing the side effects of propofol; therefore, it is not recommended to use propofol as an anesthesia agent for a TUGOR procedure.",2020,"The reproductive outcomes (numbers of collected oocytes, fertilized oocytes and transferred embryos, pregnancy rates) showed better but non-significant ranges in remifentanil group. ","['Trans-Vaginal Ultrasonography Oocyte Retrieval (TUGOR) on Pregnancy and Anesthesia Outcomes', '180 candidates of TUGOR, aged 18-40 years old, were included in the study']","['Remifentanil with or without Propofol', 'Transvaginal Ultrasound-Guided Oocyte Retrieval (TUGOR', 'midazolam 0.03 mg/kg and remifentanil', 'remifentanil with or without propofol, administrated for TUGOR', 'remifentanil', 'remifentanil & propofol', 'remifentanil infusion 0.25 μg/kg/min and the control group received remifentanil infusion 1ug/kg/min with propofol 50-150 ug/kg/min']","['Hemodynamic symptoms, operation outcomes including the side effects, and pregnancy outcomes', 'reproductive outcomes (numbers of collected oocytes, fertilized oocytes and transferred embryos, pregnancy rates', 'durations of operation, anesthesia and recovery']","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1300567', 'cui_str': 'mcg/kg/min'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",180.0,0.0809587,"The reproductive outcomes (numbers of collected oocytes, fertilized oocytes and transferred embryos, pregnancy rates) showed better but non-significant ranges in remifentanil group. ","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Atashkhoei', 'Affiliation': ""Department of Anesthesiology, school of Medicine, Women's Reproduction Health Research Center, Al-Zahra Teaching Hospital, Tabriz University of Medical Sciences, Tabriz. Iran.""}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Pouya', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara University School of Medicine, Ankara. Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Hakimi', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Tabriz University of Medical Sciences, Tabriz. Iran.'}, {'ForeName': 'Raana', 'Initials': 'R', 'LastName': 'Zakeri', 'Affiliation': 'Department of Health Services Management, School of Management and Medical Informatics, Iranian International Safe Community Support Center, Tabriz University of Medical Sciences, Tabriz. Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Soltanzadeh', 'Affiliation': 'School of Medicine, Tabriz University of Medical Sciences, Tabriz. Iran.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Hatami-Marandi', 'Affiliation': 'School of Medicine, Tabriz University of Medical Sciences, Tabriz. Iran.'}]",Current clinical pharmacology,['10.2174/1574884715666200623161856'] 2509,32576151,Intravenous lidocaine to prevent endothelial dysfunction after major abdominal surgery: a randomized controlled pilot trial.,"BACKGROUND Major abdominal surgery is associated with endothelial glycocalyx disruption. The anti-inflammatory effects of lidocaine were recently associated with endothelial barrier protection. METHODS This was a single-centre, parallel group, randomized, controlled, double blind, pilot trial. Forty adult patients scheduled for major abdominal surgery were included between December 2016 and March 2017 in the setting of a University Hospital in Brussels (Belgium); reasons for non-inclusion were planned liver resection and conditions associated to increased risk of local anesthetics systemic toxicity. Patients were randomized to receive either lidocaine by continuous intravenous administration or an equivalent volume of 0.9% saline. The primary endpoint was the postoperative syndecan-1 concentration (difference between groups). Near-infrared spectroscopy of the thenar eminence in association with the vascular occlusion test, and contemporary analysis of flow-mediated dilation of the brachial artery were the secondary outcomes, along with haemodynamic data. Blood samples and data were collected before surgery (T0), and at 1-3 h (T1) and 24 h (T2) post-surgery. RESULTS Syndecan-1 concentration increased significantly post-surgery (P < 0.001), but without any difference between groups. The near-infrared spectroscopy-derived and flow-mediated dilation-derived variables showed minor changes unrelated to group assignment. Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management. Postoperative lactate concentrations were similar between groups. CONCLUSIONS Lidocaine failed to have any effect on endothelial function. Since in comparisons to other types of clinical situations, syndecan-1 was only slightly upregulated, endothelial dysfunction after major abdominal surgery might be overestimated. TRIAL REGISTRATION « ISRCTN Registry » identifier: ISRCTN63417725. Date: 15/06/2020. Retrospectively registered.",2020,"Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management.","['after major abdominal surgery', 'Forty adult patients scheduled for major abdominal surgery were included between December 2016 and March 2017 in the setting of a University Hospital in Brussels (Belgium); reasons for non-inclusion were planned liver resection and conditions associated to increased']","['Intravenous lidocaine', 'Lidocaine', 'lidocaine by continuous intravenous administration or an equivalent volume of 0.9% saline', 'lidocaine', 'placebo']","['endothelial function', 'peri-operative mean arterial pressure and cardiac index', 'Postoperative lactate concentrations', 'Syndecan-1 concentration', 'postoperative syndecan-1 concentration', 'risk of local anesthetics systemic toxicity', 'endothelial dysfunction']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4761262', 'cui_str': 'Local anaesthetic systemic toxicity'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",40.0,0.615618,"Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pustetto', 'Affiliation': 'Department of Anesthesiology, Centre Hospitalier Universitaire Grenoble-Alpes, Boulevard de la Chantourne, 38700, Grenoble, France. marco.pustetto@gmail.com.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Goldsztejn', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Touihri', 'Affiliation': 'Department of Anesthesiology, CHIREC Hospital group, Brussels, Belgium.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Engelman', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ickx', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Obbergh', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}]",BMC anesthesiology,['10.1186/s12871-020-01075-x'] 2510,32576228,"Effects of soy milk consumption on gut microbiota, inflammatory markers, and disease severity in patients with ulcerative colitis: a study protocol for a randomized clinical trial.","BACKGROUND Several strategies are recommended to alleviate clinical symptoms of ulcerative colitis (UC). Soy milk may affect UC through its anti-inflammatory properties. However, no study has examined the effects of soy milk consumption on gut microbiota and inflammatory biomarkers in patients with UC. The current study will be done to examine the effects of soy milk consumption on UC symptoms, inflammation, and gut microbiota in patients with UC. METHODS This study is a randomized clinical trial, in which thirty patients with mild to moderate severity of UC will be randomly allocated to receive either 250 mL/day soy milk plus routine treatments (n = 15) or only routine treatments (n = 15) for 4 weeks. Assessment of anthropometric measures and biochemical indicators including serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interferon gamma (IFN-γ) will be done at the study baseline and end of trial. In addition, the quantity of butyrate-producing bacteria including Clostridium cluster IV, Faecalibacterium prausnitzii, and Roseburia spp.; prebiotic bacteria including Lactobacillus spp. and Bifidobacteria spp.; and mucus-degrading bacteria including Akkermansia muciniphila, Bacteroides fragilis, and Ruminococcus spp., as well as calprotectin and lactoferrin levels, will be explored in fecal samples. Also, the Firmicutes to Bacteroidetes ratio which is of significant relevance in human gut microbiota composition will be assessed. DISCUSSION Altered gut microbiota has been reported as an important contributing factor to inflammation in patients with inflammatory bowel disease (IBD). Soy milk contains several components such as phytoestrogens with potential anti-inflammatory properties. This product might affect gut microbiota through its protein and fiber content. Therefore, soy milk might beneficially affect systemic inflammation, gut microbiota, and then clinical symptoms in patients with UC. TRIAL REGISTRATION Iranian Registry of Clinical Trials (www.irct.ir) IRCT20181205041859N1. Registered on 27 January 2019.",2020,"In addition, the quantity of butyrate-producing bacteria including Clostridium cluster IV, Faecalibacterium prausnitzii, and Roseburia spp.","['thirty patients with mild to moderate severity of UC', 'patients with inflammatory bowel disease (IBD', 'patients with ulcerative colitis', 'patients with UC']","['soy milk consumption', '250\u2009mL/day soy milk plus routine treatments (n\u2009=\u200915) or only routine treatments']","['gut microbiota and inflammatory biomarkers', 'gut microbiota, inflammatory markers, and disease severity', 'serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interferon gamma (IFN-γ', 'UC symptoms, inflammation, and gut microbiota', 'calprotectin and lactoferrin levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0452741', 'cui_str': 'Soya milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0663663,"In addition, the quantity of butyrate-producing bacteria including Clostridium cluster IV, Faecalibacterium prausnitzii, and Roseburia spp.","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sadeghi', 'Affiliation': 'Students Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Milajerdi', 'Affiliation': 'Students Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Davar', 'Initials': 'SD', 'LastName': 'Siadat', 'Affiliation': 'Department of Mycobacteriology and Pulmonary Research, Microbiology Research Center, Pasteur Institute of Iran, Tehran, Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Keshavarz', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Sima', 'Affiliation': 'Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Vahedi', 'Affiliation': 'Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Adibi', 'Affiliation': 'Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, P.O. Box 14155-6117, Tehran, Iran. a-esmaillzadeh@sina.tums.ac.ir.'}]",Trials,['10.1186/s13063-020-04523-8'] 2511,32576229,"Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials.","BACKGROUND Migraine clinical profile may change with age, making it necessary to verify that migraine treatments are equally safe and effective in older patients. These analyses evaluated the effects of patient age on the pharmacokinetics (PK), efficacy, and safety of galcanezumab for prevention of migraine. METHODS Analyses included efficacy data from three double-blind phase 3 clinical trials: two 6-month studies in episodic migraine (EVOLVE-1, EVOLVE-2: N = 1773) and one 3-month study in chronic migraine (REGAIN:N = 1113). Patients were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. Safety and PK data included additional phase 2 and phase 3 trials for a larger sample size of patients > 60 years (range = 18-65 for all studies). Subgroup analyses assessed efficacy measures, adverse event (AE) occurrence, and cardiovascular measurement changes by patient age group. Galcanezumab PK were evaluated using a population analysis approach, where age was examined as a potential covariate on apparent clearance (CL/F) and apparent volume of distribution (V/F) of galcanezumab. RESULTS Numbers of baseline monthly migraine headache days were similar across age groups. There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use. Age (18-65) had a minimal effect on CL/F, and no effect on V/F. Galcanezumab-treated patients ≥60 years experienced no clinically meaningful increases in blood pressure and no increased frequency in treatment-emergent AEs, discontinuations due to AEs, serious adverse events (SAEs) overall, or cardiovascular SAEs, compared to age-matched placebo-treated patients. CONCLUSIONS Age (up to 65 years) does not affect efficacy in migraine prevention and has no clinically meaningful influence on galcanezumab PK to warrant dose adjustment. Furthermore, older galcanezumab-treated patients experienced no increases in frequency of AEs or increases in blood pressure compared with age-matched placebo-treated patients. TRIAL REGISTRATIONS EVOLVE-1 (NCT02614183, registered 23 November 2015), EVOLVE-2 (NCT02614196, 23 November 2015), REGAIN (NCT02614261, 23 November 2015), ART-01 (NCT01625988, 20 June 2012, ), I5Q-MC-CGAB (NCT02163993, 12 June 2014, ), I5Q-MC-CGAJ (NCT02614287, 23 November 2015, ), all retrospectively registered.",2020,"There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use.","['adult patients with migraine', 'episodic migraine (EVOLVE-1, EVOLVE-2: N\xa0=\u20091773) and one 3-month study in chronic migraine (REGAIN:N\xa0=\u20091113', 'larger sample size of patients >\u200960\u2009years (range\u2009=\u200918-65 for all studies', 'older patients']","['galcanezumab', 'Galcanezumab PK', 'placebo, galcanezumab 120\u2009mg, or galcanezumab 240\u2009mg']","['pharmacokinetics (PK), efficacy, and safety', 'blood pressure', 'frequency in treatment-emergent AEs, discontinuations due to AEs, serious adverse events (SAEs) overall, or cardiovascular SAEs', 'pharmacokinetics, efficacy, and safety', 'efficacy measures, adverse event (AE) occurrence, and cardiovascular measurement changes', 'frequency of AEs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.113351,"There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use.","[{'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA. vstauffer@lilly.com.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Turner', 'Affiliation': 'Center for Headache Care and Research, Island Neurological Associates, a division of ProHEALTHcare Associates, Plainview, NY, USA.'}, {'ForeName': 'Phebe', 'Initials': 'P', 'LastName': 'Kemmer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kielbasa', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Day', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Port', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Quinlan', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Camporeale', 'Affiliation': 'Eli Lilly Italia, Sesto Fiorentino, Italy.'}]",The journal of headache and pain,['10.1186/s10194-020-01148-9'] 2512,31386987,Repeated stress leads to enhanced cortisol stress response in child social anxiety disorder but this effect can be prevented with CBT.,"Social anxiety disorder (SAD) is associated with continual social stress in everyday life. Two physiological components of stress are the hypothalamus-pituitary-adrenal axis, as captured by cortisol reactivity, and the autonomous nervous system, as captured by salivary alpha amylase (sAA) reactivity. In children with SAD, initial evidence points to dysregulated physiological stress reactivity for both systems. Furthermore, hardly any studies have assessed stress reactivity twice, including exploring possible changes after cognitive behavioral therapy (CBT). Children with SAD (n = 65; aged 9-13 years) and healthy controls (HCs, n = 55) participated in a social stress task (Trier Social Stress Test for Children, TSST-C), which was repeated with children with SAD after either 12 sessions of CBT or a waiting period to explore possible habituation or sensitization effects. Before treatment, children in the SAD and HC groups did not differ in their cortisol stress reactivity toward the TSST-C but did differ in their sAA response with a more pronounced response in the SAD group. After treatment, children with SAD in the waitlist group differed from children with SAD in the CBT group by showing stronger cortisol reactivity and a higher responder rate, indicative of a possible sensitization to stress. No difference was found for sAA. Future research should compare children with SAD and HC children concerning the effect of repeated stress on sensitization.",2019,"Before treatment, children in the SAD and HC groups did not differ in their cortisol stress reactivity toward the TSST-C but did differ in their sAA response with a more pronounced response in the SAD group.","['Children with SAD (n = 65; aged 9-13 years) and healthy controls (HCs, n = 55) participated in a', 'child social anxiety disorder', 'children with SAD and HC children']","['social stress task (Trier Social Stress Test for Children, TSST-C']","['cortisol stress reactivity', 'cortisol reactivity', 'Social anxiety disorder (SAD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",65.0,0.0156561,"Before treatment, children in the SAD and HC groups did not differ in their cortisol stress reactivity toward the TSST-C but did differ in their sAA response with a more pronounced response in the SAD group.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Asbrand', 'Affiliation': 'Institute of Psychology, Albert Ludwig University of Freiburg, Germany. Electronic address: Julia.asbrand@psychologie.uni-freiburg.de.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, University of Braunschweig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Nitschke', 'Affiliation': 'Institute of Psychology, Albert Ludwig University of Freiburg, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Ruhr University Bochum, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schmidtendorf', 'Affiliation': 'Department of Psychology, University of Braunschweig, Germany.'}, {'ForeName': 'Brunna', 'Initials': 'B', 'LastName': 'Tuschen-Caffier', 'Affiliation': 'Institute of Psychology, Albert Ludwig University of Freiburg, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.06.003'] 2513,32583959,Bedside ultrasound in the emergency department for reduction and radial manipulation of distal radial fractures.,"OBJECTIVE Distal radial fracture reduction is a common procedure in the ED. Previous studies have suggested that ultrasound (US)-guided reduction improves outcomes for patients who undergo manipulation and reduction of distal radial fractures in the ED. We aimed to investigate this with the first randomised controlled trial looking at US-guided distal radial fracture reduction. Our primary objective was to compare rates of operative intervention between the study groups. Rate of re-manipulation was compared as a secondary outcome. METHODS ED patients were prospectively randomised to either standard landmark guided or US-guided closed reduction of distal radial fractures. The closed reductions were performed by senior emergency clinicians and the USs were performed by emergency physicians experienced in point-of-care US. Following reduction patients were managed equally and referred to the local orthopaedic service who were blinded to whether US was used to assist manipulation or not. This service decided on the need for re-manipulation or operative intervention. RESULTS One hundred patients were enrolled and randomised equally into each cohort. We found no statistically significant difference between the control and intervention groups of our study. In the control group, 46% of patients underwent operative fixation, compared to 48% in the US-guided group (P = 0.36). Our secondary intervention of re-manipulation in the ED or theatre following the initial reduction showed no statistically significant difference between the groups (P = 1.0). CONCLUSION US-guided reduction of dorsally displaced, distal radius fractures in the ED setting, did not improve measured clinical outcomes.",2020,"In the control group, 46% of patients underwent operative fixation, compared to 48% in the US-guided group (P = 0.36).","['Following reduction patients were managed equally and referred to the local orthopaedic service', 'ED patients', 'One hundred patients were enrolled and randomised equally into each cohort']","['Bedside ultrasound', 'standard landmark guided or US-guided closed reduction of distal radial fractures', 'ultrasound (US)-guided reduction']","['Rate of re-manipulation', 'distal radial fractures']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0587690', 'cui_str': 'Orthopedic service'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}]",100.0,0.0515807,"In the control group, 46% of patients underwent operative fixation, compared to 48% in the US-guided group (P = 0.36).","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Smiles', 'Affiliation': 'Emergency Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Simonian', 'Affiliation': 'Orthopaedics, Mater Hospital Brisbane, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Emergency Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Digby', 'Affiliation': 'Emergency Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Vidler', 'Affiliation': 'Emergency Department, Maitland Hospital, Maitland, New South Wales, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Flannagan', 'Affiliation': 'Emergency Department, Maitland Hospital, Maitland, New South Wales, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13554'] 2514,32583971,Randomized Controlled Trial of Patient Education Tools for Patients with Rheumatoid Arthritis.,"OBJECTIVE We evaluated the efficacy of two educational tools for patients with rheumatoid arthritis (RA). A newly developed video tool including storylines and testimonials combined with a written booklet was compared with the same written booklet alone. METHODS We conducted a randomized controlled trial. Our primary outcome was disease knowledge. Secondary outcomes were decisional conflict, self-efficacy, effective healthcare management, and satisfaction.Outcomes were measured before and after reviewing the materials, and 3 and 6 months later. Linear mixed effects models were performed to evaluate changes over time. RESULTS Two hundred and twenty-one participants received an educational video and booklet (n=111) or a booklet alone (n=110). The mean age was 50.8 years, mean disease duration was 4.8 years, 85% were female, and 24% had limited health literacy levels. Within groups, most outcomes improved between baseline and follow-up, but there were no statistically significant differences across groups. Patients receiving the video and booklet were more likely than those receiving the booklet alone to rate the presentation as ""excellent"" for providing information about the impact of RA, medication options, evidence about medications, benefits of medication, and self-care options. Factors significantly associated with greater improvements in knowledge and decisional conflict from baseline to 6 months included limited health literacy, lower educational level, and shorter disease duration. CONCLUSION Regardless of the delivery method, outcomes were improved up to 6 months after educational materials were delivered. Our findings support the implementation of self-administered educational materials in clinical settings as they can result in sustained improvements in disease knowledge and decisional conflict.",2020,"Factors significantly associated with greater improvements in knowledge and decisional conflict from baseline to 6 months included limited health literacy, lower educational level, and shorter disease duration. ","['Patients with Rheumatoid Arthritis', 'patients with rheumatoid arthritis (RA', 'The mean age was 50.8 years, mean disease duration was 4.8 years, 85% were female, and 24% had limited health literacy levels', 'Two hundred and twenty-one participants received an']",['educational video and booklet (n=111) or a booklet alone'],"['disease knowledge', 'knowledge and decisional conflict', 'limited health literacy, lower educational level, and shorter disease duration', 'decisional conflict, self-efficacy, effective healthcare management, and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",221.0,0.120708,"Factors significantly associated with greater improvements in knowledge and decisional conflict from baseline to 6 months included limited health literacy, lower educational level, and shorter disease duration. ","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lopez-Olivo', 'Affiliation': 'Department of Health Services Research, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Rizvi', 'Affiliation': 'Houston Rheumatology & Arthritis Specialists, Memorial Hermann, Houston, Texas, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Barbo', 'Affiliation': 'Center for Outcomes Research and Evaluation (CORE), Yale New Haven Hospital, New Haven, CT, USA.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Ingleshwar', 'Affiliation': 'University of Iowa College of Dentistry, Iowa City, Iowa, USA.'}, {'ForeName': 'Jude K A', 'Initials': 'JKA', 'LastName': 'des Bordes', 'Affiliation': 'Department of Family and Community Medicine, The University of Texas McGovern Medical School, Houston, Texas, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jibaja-Weiss', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'Department of Health Services Research, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Suarez-Almazor', 'Affiliation': 'Department of Health Services Research, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}]",Arthritis care & research,['10.1002/acr.24362'] 2515,32583973,Trabecular bone deterioration in differentiated thyroid cancer: Impact of long-term TSH suppressive therapy.,"BACKGROUND Conflicting results has been reported regard osteoporosis and fractures in patients with Differentiated Thyroid Cancer (DTC). Our objective was to evaluate the long-term effects of TSH suppression therapy with Levothyroxine (LT4) on trabecular bone score (TBS) and bone mineral density (BMD) in females with DTC after thyroidectomy. METHODS About 145 women with resected DTC and receiving long-term TSH therapy, were stratified according to the degree of TSH suppression. Mean duration of follow-up was 12.3 ± 6.1 years. BMD and TBS, were assessed using dual-energy X-ray absorptiometry (DXA) and TBS iNsight (Med-Imaps), at baseline (1-3 months after surgery) and at the final study visit. RESULTS In patients stratified by duration of TSH suppression therapy (Group I, 5-10 years; Group II, >10 years), slight increases from baseline TSH levels were observed. Significant decreases in LS-BMD and FN-BMD were seen in patients after >10 years. TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups). Regarding the degree of TSH suppression, TBS was significantly reduced in those with TSH < 0.1 µU/mL (P = .0086), and not in patients with TSH suppression of 0.1.-0.5 or >0.5 µU/mL. CONCLUSIONS We found deterioration of trabecular structure in patients with DTC and TSH suppression therapy below 0.1 µU/mL and after 5-10 years of follow-up. Significant changes in BMD according to TSH levels were not observed. Trabecular Bone Score is a useful technique for identifying thyroid cancer patients with risk of bone deterioration.",2020,"TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups).","['females with DTC after thyroidectomy', 'thyroid cancer patients with risk of bone deterioration', 'patients with Differentiated Thyroid Cancer (DTC', '145 women with resected DTC and receiving long-term TSH therapy', 'differentiated thyroid cancer']","['TSH suppression therapy', 'TSH suppression therapy with Levothyroxine (LT4', 'TSH suppressive therapy']","['trabecular bone score (TBS) and bone mineral density (BMD', 'LS-BMD and FN-BMD', 'TSH suppression, TBS', 'baseline TSH levels', 'BMD and TBS', 'Trabecular bone deterioration', 'TBS values', 'BMD according to TSH levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}]","[{'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",145.0,0.0222858,"TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Hawkins Carranza', 'Affiliation': 'Research Institute i+12, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Guadalix Iglesias', 'Affiliation': 'Thyroid Cancer Unit, Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Luisa De Mingo Domínguez', 'Affiliation': 'Hospital La Luz, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martín-Arriscado Arroba', 'Affiliation': 'Epidemiology Unit, Research Institute i+12, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'López Álvarez', 'Affiliation': 'Centro de Salud Goya, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Allo Miguel', 'Affiliation': 'Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Martínez Díaz-Guerra', 'Affiliation': 'Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}]",Cancer medicine,['10.1002/cam4.3200'] 2516,32583982,The Effects of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Chronic Knee Pain in Older U.S. Adults: Results from a Randomized Trial.,"OBJECTIVE Knee pain from osteoarthritis is frequent in the adult population. Prior trials have had conflicting results concerning vitamin D's therapeutic effects on knee pain and few trials have investigated marine omega-3 fatty acids (n-3 FA). METHODS The double-blind, placebo-controlled VITamin D and OmegA-3 TriaL (VITAL) randomized 25,871 U.S. adults in a two-by-two factorial design to vitamin D and n-3 FA. We identified a subgroup with chronic knee pain prior to randomization and assessed knee pain at baseline and annually during follow-up with the Western Ontario and McMaster Universities Arthritis Index (WOMAC; 0-100, 100 worst). Repeated measures modeling tested the effect of randomized treatment on WOMAC Pain over follow-up after adjustment for age and sex. Analyses were repeated for WOMAC Function and Stiffness. RESULTS We included 1,398 participants who returned at least one knee pain questionnaire. Mean age was 67.7 years, 66% were female, and mean WOMAC Pain was 37 (SD 19). Mean follow-up time was 5.3 years (SD 0.7). WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up. Linear time by treatment interactions were not statistically significant for either treatment (vitamin D p= 0.41, n-3 FA p= 0.77). Vitamin D and n-3 FA supplementation did not significantly affect WOMAC Function or Stiffness scores over time. CONCLUSION Vitamin D and n-3 FA supplementation for a mean of 5.3 years did not reduce knee pain or improve function or stiffness in a large sample of U.S adults with chronic knee pain.",2020,WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up.,"['1,398 participants who returned at least one knee pain questionnaire', 'subgroup with chronic knee pain prior to randomization and assessed knee pain at baseline and annually during follow-up with the Western Ontario and McMaster Universities Arthritis Index', 'adults with chronic knee pain', 'Older U.S. Adults', 'Mean age was 67.7 years, 66% were female, and mean WOMAC Pain was 37 (SD 19']","['vitamin D and n-3 FA', 'Vitamin D and n-3 FA supplementation', 'placebo-controlled VITamin D and OmegA-3 TriaL', 'vitamin D or n-3 FA and placebo', 'Vitamin D and Marine Omega-3 Fatty Acid Supplementation']","['knee pain', 'Chronic Knee Pain', 'WOMAC Function or Stiffness scores', 'WOMAC Function and Stiffness', 'WOMAC Pain']","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",25871.0,0.401195,WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up.,"[{'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'MacFarlane', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Maura D', 'Initials': 'MD', 'LastName': 'Iversen', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.""}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41416'] 2517,32584199,Human and novel coronavirus infections in children: a review.,"Coronaviruses, seven of which are known to infect humans, can cause a spectrum of clinical presentations ranging from asymptomatic infection to severe illness and death. Four human coronaviruses (hCoVs)-229E, HKU1, NL63 and OC43-circulate globally, commonly infect children and typically cause mild upper respiratory tract infections. Three novel coronaviruses of zoonotic origin have emerged during the past two decades: severe acute respiratory syndrome coronavirus (SARS-CoV-1), Middle East respiratory syndrome coronavirus (MERS-CoV) and the recently discovered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is the cause of the ongoing coronavirus disease 2019 (COVID-19) pandemic. These novel coronaviruses are known to cause severe illness and death predominantly in older adults and those with underlying comorbidities. Consistent with what has been observed during the outbreaks of SARS and MERS, children with COVID-19 are more likely to be asymptomatic or to have mild-to-moderate illness, with few deaths reported in children globally thus far. Clinical symptoms and laboratory and radiological abnormalities in children have been similar to those reported in adults but are generally less severe. A rare multisystem inflammatory syndrome in children (MIS-C) which has resulted in critical illness and some deaths has recently been described. Clinical trials for therapeutics and vaccine development should include paediatric considerations. Children may play an important role in the transmission of infection and outbreak dynamics and could be a key target population for effective measures to control outbreaks. The unintended consequences of the unprecedented scale and duration of pandemic control measures for children and families around the world should be carefully examined. ABBREVIATIONS 2019-nCoV, 2019 novel coronavirus; ADEM, acute demyelinating encephalomyelitis; AAP, American Academy of Pediatrics; ACE-2, angiotensin-converting enzyme 2; ARDS, acute respiratory distress syndrome; BCG, bacillus Calmette-Guérin; BNP, brain natriuretic peptide; CDC, Centers for Disease Control and Prevention; CRP, C-reactive protein; CSF, cerebrospinal fluid; COVID-19, coronavirus disease 2019; CT, computed tomography; CXR, chest X-ray; DOL, day of life; hCoV, human coronavirus; ICU, intensive care unit; IL, interleukin; IVIG, intravenous immunoglobulin; KD, Kawasaki disease; LDH, lactate dehydrogenase; MERS, Middle East respiratory syndrome; MERS-CoV, Middle East respiratory syndrome coronavirus; MEURI, monitored emergency use of unregistered and experimental interventions; MIS-C, multi-system inflammatory syndrome in children; PCR, polymerase chain reaction; PICU, paediatric intensive care unit; RNA, ribonucleic acid; RCT, randomised-controlled trial; RSV, respiratory syncytial virus; SARS, severe acute respiratory syndrome; SARS-CoV-1, severe acute respiratory syndrome coronavirus 1; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TNF-alpha, tumour necrosis factor alpha; UK United Kingdom; UNICEF, United Nations Children's Fund; USA, United States of America; WHO, World Health Organization.",2020,"Three novel coronaviruses of zoonotic origin have emerged during the past two decades: severe acute respiratory syndrome coronavirus (SARS-CoV-1), Middle East respiratory syndrome coronavirus (MERS-CoV) and the recently discovered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is the cause of the ongoing coronavirus disease 2019 (COVID-19) pandemic.","['children (MIS-C', 'children and families', 'children']",[],['Clinical symptoms and laboratory and radiological abnormalities'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.0673214,"Three novel coronaviruses of zoonotic origin have emerged during the past two decades: severe acute respiratory syndrome coronavirus (SARS-CoV-1), Middle East respiratory syndrome coronavirus (MERS-CoV) and the recently discovered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is the cause of the ongoing coronavirus disease 2019 (COVID-19) pandemic.","[{'ForeName': 'Nipunie', 'Initials': 'N', 'LastName': 'Rajapakse', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic , Rochester, MN, USA.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Dixit', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics and Internal Medicine, University of Saskatchewan , Saskatoon, Saskatchewan, Canada.'}]",Paediatrics and international child health,['10.1080/20469047.2020.1781356'] 2518,32584211,Predictors and moderators of treatment dropout in cognitive-behavioral and psychodynamic therapies for panic disorder.,"Introduction: Panic disorder patients who drop out of treatment typically do not remit from their disorder. How patient-level moderators influence dropping out of one panic-focused treatment over another has never been examined, nor in non-CBT treatments. Method: 200 patients with panic disorder with or without agoraphobia were randomized to receive cognitive-behavioral therapy (CBT), panic-focused psychodynamic psychotherapy (PFPP), or applied relaxation training (ART) across two sites. Therapy was twice a week for 12 weeks. A two-step variable search method was applied to identify potential prognostic predictors and moderators of patient dropout. Survival models predicting hazard of session-by-session dropout tested the resulting variables. Results: Across treatments, unemployment and higher psychosocial disability on the Sheehan Disability Scale predicted increased risk of dropout, while patients with higher anxiety sensitivity were more likely to complete treatment. Patients who reported experiencing childhood abuse had heightened dropout in ART, but not CBT or PFPP. Men were especially likely to complete PFPP. Session 2 expectancies and patient-rated alliance predicted lower dropout only in CBT. Conclusions: Patient-level factors may influence both whether patients will complete any treatment, and whether they continue in a particular panic-focused therapy. Moderators of dropout (e.g., abuse history) may inform treatment decisions for specific patients. Trial registration: ClinicalTrials.gov identifier: NCT00353470.",2020,"Across treatments, unemployment and higher psychosocial disability on the Sheehan Disability Scale predicted increased risk of dropout, while patients with higher anxiety sensitivity were more likely to complete treatment.","['panic disorder', '200 patients with panic disorder with or without agoraphobia', 'Patients who reported experiencing childhood abuse had heightened dropout in ART, but not CBT or PFPP', 'Panic disorder patients who drop out of treatment typically do not remit from their disorder']","['cognitive-behavioral therapy (CBT), panic-focused psychodynamic psychotherapy (PFPP), or applied relaxation training (ART', 'cognitive-behavioral and psychodynamic therapies']",['anxiety sensitivity'],"[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",200.0,0.0162106,"Across treatments, unemployment and higher psychosocial disability on the Sheehan Disability Scale predicted increased risk of dropout, while patients with higher anxiety sensitivity were more likely to complete treatment.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Keefe', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Dianne L', 'Initials': 'DL', 'LastName': 'Chambless', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Milrod', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1784487'] 2519,32584219,Gluteus Medius Insertion Damage: A Comparison of Reconstruction and Hip Fracture Nails.,"This study assessed damage to the gluteus medius tendon insertion when performing trochanteric nailing with either a reconstruction nail or a cephalomedullary nail. Ten cadavers were randomized to receive proximal reaming for either a reconstruction nail or cephalomedullary nail; the contralateral hip served as an internal control. One specimen was found to have a displaced femoral neck fracture and was excluded from data analysis. Reconstruction nailing led to tendon damage in 4 of 9 hips, compared to 8 of 9 with hip fracture nailing (p = 0.29). In the reconstruction nail group, the average amount of tendon damaged was 3% (range 0-10%), while in the hip fracture nail group, the average was 15% (range 0-20.3%) (p = 0.0003). Open reaming for placement of a reconstruction nail caused less gluteus medius tendon damage when compared to open reaming for placement of a hip fracture nail. (Journal of Surgical Orthopaedic Advances 29(2):77-80, 2020).",2020,Open reaming for placement of a reconstruction nail caused less gluteus medius tendon damage when compared to open reaming for placement of a hip fracture nail.,[],"['open reaming', 'trochanteric nailing with either a reconstruction nail or a cephalomedullary nail', 'Reconstruction and Hip Fracture Nails', 'proximal reaming for either a reconstruction nail or cephalomedullary nail; the contralateral hip served as an internal control', 'Reconstruction nailing', 'hip fracture nailing', 'Open reaming']","['tendon damage', 'average amount of tendon damaged']",[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",10.0,0.0165445,Open reaming for placement of a reconstruction nail caused less gluteus medius tendon damage when compared to open reaming for placement of a hip fracture nail.,"[{'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Hurley', 'Affiliation': 'San Antonio Military Medical Center, Fort Sam Houston, Texas.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sheean', 'Affiliation': 'San Antonio Military Medical Center, Fort Sam Houston, Texas.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Beltran', 'Affiliation': 'San Antonio Military Medical Center, Fort Sam Houston, Texas.'}]",Journal of surgical orthopaedic advances,[] 2520,32584260,"Evaluation of the Clinical and Economic Effects of a Primary Care Anchored, Collaborative, Electronic Health Lifestyle Coaching Program in Denmark: Protocol for a Two-Year Randomized Controlled Trial.","BACKGROUND Obesity is linked to a number of chronic health conditions, such as type 2 diabetes, heart disease, and cancer, and weight loss interventions are often expensive. Recent systematic reviews concluded that app and web-based interventions can improve lifestyle behaviors and weight loss at a reasonable cost, but long-term sustainability needs to be demonstrated. OBJECTIVE This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and economic effects of a primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA] 2.0) in obese participants with and without type 2 diabetes. The program's primary outcome is weight loss. Its secondary outcome is the hemoglobin A 1c (HbA 1c ) level, and its tertiary outcomes are retention rate, quality of life (QOL), and cost effectiveness. Analytically, the focus is on associations of participant characteristics with outcomes and sustainability. METHODS We conduct a multicenter trial with a 1-year intervention and 1-year retention. LIVA 2.0 is implemented in municipalities within administrative regions in Denmark, specifically eight municipalities located within the Region of Southern Denmark and two municipalities located within the Capital Region of Denmark. The participants are assessed at baseline and at 6-, 12-, and 24-month follow-ups. Individual data from the LIVA 2.0 platform are combined with clinical measurements, questionnaires, and participants' usage of municipality and health care services. The participants have a BMI ≥30 but ≤45 kg/m2, and 50% of the participants have type 2 diabetes. The participants are randomized in an approximately 60:40 manner, and based on sample size calculations on weight loss and intention-to-treat statistics, 200 participants are randomized to an intervention group and 140 are randomized to a control group. The control group is offered the conventional preventive program of the municipality, and it is compared to the intervention group, which follows the LIVA 2.0 in addition to the conventional preventive program. RESULTS The first baseline assessments have been carried out in March 2018, and the 2-year follow-up will be carried out between March 2020 and April 2021. The hypothesis is that the trial results will demonstrate decreased body weight and that the number of patients who show normalization of their HbA 1c levels in the intervention group will be much higher than that in the control group. The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group. Operational costs are expected to be lower than standard care, and the intervention is expected to be cost-effective. CONCLUSIONS This is the first time that an app and web-based eHealth lifestyle coaching program implemented in Danish municipalities will be clinically and economically evaluated. If the LIVA 2.0 eHealth lifestyle coaching program is proven to be effective, there is great potential for decreasing the rates of obesity, diabetes, and related chronic diseases. TRIAL REGISTRATION ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/19172.",2020,The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group.,"['Denmark', 'participants have a BMI ≥30 but ≤45 kg/m2, and 50% of the participants have type 2 diabetes', 'obese participants with and without type 2 diabetes']","['Primary Care Anchored, Collaborative, Electronic Health Lifestyle Coaching Program', 'primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA']","['lifestyle behaviors and weight loss', 'body weight', 'QOL', 'hemoglobin', 'weight loss', 'retention rate, quality of life (QOL), and cost effectiveness', 'glucose-lowering medication', 'Operational costs']","[{'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.106368,The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group.,"[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Brandt', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jeanette Reffstrup', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jesper Bo', 'Initials': 'JB', 'LastName': 'Nielsen', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Søndergaard', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Sortsø', 'Affiliation': 'LIVA Healthcare, Copenhagen, Denmark.'}]",JMIR research protocols,['10.2196/19172'] 2521,32445690,"Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial.","BACKGROUND Several small studies suggest that the adjunctive use of anti-inflammatory agents might improve depressive symptoms in bipolar disorder. However, there are few well designed, appropriately powered clinical trials assessing the efficacy of these novel treatment strategies. We aimed to assess the efficacy of adjunctive minocycline or celecoxib in this setting. METHODS This double-blind, 12-week, randomised, placebo-controlled trial was done in four outpatient psychiatric clinics in Pakistan. Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode. In a 2 × 2 factorial design, participants were randomly assigned (1:1:1:1) to receive either active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib. The primary outcome was the mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17), assessed in all randomised participants (missing data were imputed and assumed to be missing at random). The trial was registered with ClinicalTrials.gov, NCT02703363. FINDINGS 266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019, were randomly assigned to receive minocycline plus celecoxib (n=68), minocycline plus placebo (n=66), celecoxib plus placebo (n=66), or placebo plus placebo (n=66). From baseline to week 12, depressive symptoms as per HAMD-17 reduced in all four groups (from 24·5-25·2 to 11·3-12·8), but these reductions did not differ significantly between the groups. In terms of main effects, reductions in HAMD-17 did not differ for patients treated with minocycline (mean adjusted difference vs non-minocycline 1·48 [95% CI -0·41 to 3·36]; p=0·123) or for celecoxib (mean adjusted difference vs non-celecoxib -0·74 [-2·61 to 1·14]; p=0·443). Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident). INTERPRETATION We found no evidence that minocycline or celecoxib was superior to placebo for the treatment of bipolar depression. This large trial casts doubt on the potential therapeutic benefits of adjunctive anti-inflammatory drugs for the acute management of bipolar depression. FUNDING Stanley Medical Research Institute.",2020,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident). ","['266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019', 'four outpatient psychiatric clinics in Pakistan', 'bipolar depression', 'Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode']","['Minocycline and celecoxib', 'active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib', 'adjunctive minocycline or celecoxib', 'minocycline plus placebo', 'celecoxib plus placebo', 'minocycline', 'placebo plus placebo', 'celecoxib', 'minocycline plus celecoxib', 'placebo']","['HAMD-17', 'depressive symptoms as per HAMD-17', 'mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17', 'Rates of serious adverse effects', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.814161,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident). ","[{'ForeName': 'Muhammad Ishrat', 'Initials': 'MI', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: ishrat.husain@camh.ca.'}, {'ForeName': 'Imran B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; Pakistan Institute of Learning and Living, Karachi, Pakistan; Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan; Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Ameer B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Learning and Living, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Omair', 'Initials': 'MO', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Moin A', 'Initials': 'MA', 'LastName': 'Ansari', 'Affiliation': 'Department of Psychiatry, Liaquat University of Medical and Health Sciences, Hyderabad, Pakistan.'}, {'ForeName': 'Haider A', 'Initials': 'HA', 'LastName': 'Naqvi', 'Affiliation': 'Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Fareed A', 'Initials': 'FA', 'LastName': 'Minhas', 'Affiliation': 'Institute of Psychiatry, Rawalpindi Medical College, Rawalpindi, Pakistan.'}, {'ForeName': 'Andre F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Meyer', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Deakin', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30138-3'] 2522,32583937,Improved Psychosocial and Functional Outcomes and Reduced Opioid Usage Following Burst Spinal Cord Stimulation.,"OBJECTIVE Burst spinal cord stimulation (B-SCS) has been shown to reduce neuronal firing in the anterior cingulate cortex through selective modulation of the medial pain pathway tract. This pain pathway communicates the affective component of pain processing. The purpose of this study was to assess the effect of B-SCS on psychosocial functioning and its influence on pain and quality of life. MATERIALS AND METHODS Eligible patients with chronic, intractable pain of the trunk, and/or lower limbs were enrolled. After a successful trial period, subjects received a permanent implant and returned for follow-up at 6- and 12-months. RESULTS In total, 269 patients were enrolled at 22 centers. Trial success rate was 90%. Significant improvements in pain, physical, mental, and emotional functioning were observed from baseline to the 6- and 12-month follow-up (p < 0.001). Overall, patients had improved quality of life, became more active, and the negative impact of pain on daily life was decreasing. At one year, 81% of subjects were satisfied or very satisfied with their therapy. Subjects showing significant improvements on mental health outcomes reported enhanced pain relief and quality of life scores compared with subjects with continued impaired mental health at follow-up. At one year, 89% of subjects who were taking opioids at baseline decreased or stayed at the same level of opioid use; 19% stopped taking any opioids. No unanticipated adverse events have been reported. CONCLUSIONS One-year outcomes after B-SCS show improvements across all evaluated psychological measures with the largest impact observed on catastrophizing and depression (the affective component of pain processing). These pain-related beliefs and behaviors, and not pain intensity, have been shown to put patients at greatest risk of a poor prognosis and quality of life.",2020,Subjects showing significant improvements on mental health outcomes reported enhanced pain relief and quality of life scores compared with subjects with continued impaired mental health at follow-up.,"['269 patients were enrolled at 22 centers', 'Eligible patients with chronic, intractable pain of the trunk, and/or lower limbs were enrolled']","['B-SCS', 'Burst spinal cord stimulation (B-SCS']","['quality of life', 'Improved Psychosocial and Functional Outcomes and Reduced Opioid Usage', 'pain, physical, mental, and emotional functioning', 'pain and quality of life', 'mental health outcomes', 'Trial success rate', 'mental health', 'negative impact of pain on daily life', 'pain relief and quality of life scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",269.0,0.0638024,Subjects showing significant improvements on mental health outcomes reported enhanced pain relief and quality of life scores compared with subjects with continued impaired mental health at follow-up.,"[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Falowski', 'Affiliation': 'Neurosurgical Associates of Lancaster, Lancaster, PA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Moore', 'Affiliation': 'Pacific Sports and Interventional Spine, Eugene, OR, USA.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Cornidez', 'Affiliation': 'Pain Institute of Southern Arizona, Tucson, AZ, USA.'}, {'ForeName': 'J Kelby', 'Initials': 'JK', 'LastName': 'Hutcheson', 'Affiliation': 'Carolinas Center for Advanced Management of Pain, Columbia, SC, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Candido', 'Affiliation': 'Chicago Anesthesia Associates Sc, Chicago, IL, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Peña', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Blomme', 'Affiliation': 'Abbott (formerly St Jude Medical), Austin, TX, USA.'}, {'ForeName': 'Robyn A', 'Initials': 'RA', 'LastName': 'Capobianco', 'Affiliation': 'Abbott (formerly St Jude Medical), Austin, TX, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13226'] 2523,32583947,Stapled hemorrhoidopexy for grade III hemorrhoids with circular prolapse - a video vignette.,"Hemorrhoidal disease (HD) is one of the most common anorectal disorders seen in the proctology practise [1]. Stapled hemorrhoidopexy (SH) has been reported as a highly effective alternative to other invasive approaches [2]. However, a recently published randomized controlled trial concluded that SH was worse for recurrence rates, symptoms, re-interventions and quality-of-life measures compared to traditional haemorrhoidectomy [3]. In addition, SH is more expensive.",2020,Hemorrhoidal disease (HD) is one of the most common anorectal disorders seen in the proctology practise [1].,['grade III hemorrhoids with circular prolapse - a video vignette'],"['Stapled hemorrhoidopexy (SH', 'SH', 'Stapled hemorrhoidopexy']","['recurrence rates, symptoms, re-interventions and quality-of-life measures']","[{'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0934714,Hemorrhoidal disease (HD) is one of the most common anorectal disorders seen in the proctology practise [1].,"[{'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Samalavicius', 'Affiliation': 'Department of Surgery, Klaipeda University Hospital, Klaipeda, Lithuania.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Klimasauskiene', 'Affiliation': 'Department of Surgery, Klaipeda University Hospital, Klaipeda, Lithuania.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nausediene', 'Affiliation': 'Department of Surgery, Klaipeda University Hospital, Klaipeda, Lithuania.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dulskas', 'Affiliation': 'Institute of Clinical Medicine Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15216'] 2524,32583957,A pooled analysis of three randomized phase I/IIa clinical trials confirms absence of a clinically relevant effect on the QTc interval by umibecestat.,"Umibecestat, an orally active β-secretase (BACE-1) inhibitor, reduces the production of amyloid beta (Aβ)-peptide that accumulates in the brain of patients with Alzheimer's disease. The ECG effects of umibecestat, on QTcF (Fridericia-corrected QT), on PR and QRS and heart rate (HR), were estimated by concentration-effect modeling. Three phase-I/II studies with durations up to 3 months, with 372 healthy subjects over a wide age range, including both sexes and two ethnicities, were pooled, providing a large data set with good statistical power. No clinically relevant effect on QTcF, PR interval, QRS duration or HR were observed up to supratherapeutic doses. The upper bound of 90% confidence intervals of the ∆QTcF was below the 10 ms threshold of regulatory concern for all concentrations measured. Pre-specified sensitivity analysis confirmed the results in both sexes, in those over and below 60 years, and in Japanese subjects. All conclusions were endorsed by the FDA.",2020,"No clinically relevant effect on QTcF, PR interval, QRS duration or HR were observed up to supratherapeutic doses.","[""patients with Alzheimer's disease"", '372 healthy subjects over a wide age range, including both sexes and two ethnicities']",[],"['QTcF, PR interval, QRS duration or HR', 'ECG effects of umibecestat, on QTcF (Fridericia-corrected QT), on PR and QRS and heart rate (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]",[],"[{'cui': 'C0429087', 'cui_str': 'PR interval - finding'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",372.0,0.0353681,"No clinically relevant effect on QTcF, PR interval, QRS duration or HR were observed up to supratherapeutic doses.","[{'ForeName': 'Stefan Viktor', 'Initials': 'SV', 'LastName': 'Vormfelde', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pezous', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Lefèvre', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Kolly', 'Affiliation': 'Preclinical Safety, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Neumann', 'Affiliation': 'Neuroscience, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Jordaan', 'Affiliation': 'Cardiovascular Safety Expert - CMO and Patient Safety - Oncology, Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Legangneux', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12832'] 2525,32583994,Efficacy Of Preoperative Misoprostol In Reducing Hemorrhage During Abdominal Myomectomy.,"BACKGROUND Uterine myomas are most common non-cancerous tumours in reproductive period. The fertility preserving surgery, i.e., myomectomy as compared to hysterectomy, is associated with massive blood loss due to dissection of huge fibroids making it technically difficult procedure. Misoprostol (a uterotonic) is an effective option amongst different interventions used to reduce intraoperative blood loss during myomectomy. This randomized control trial investigated effectiveness of single dose of rectal misoprostol given preoperatively in reducing intraoperative blood loss during abdominal myomectomy.. METHODS Fifty Patients undergoing abdominal myomectomy were selected for the study. Twenty-five patients were given 800 micrograms misoprostol per rectally half an hour before surgery while rest received placebo, i.e., control group. Number and weight of surgical packs were recorded both Pre and post operatively to assess blood loss. Preoperative and 24 hrs postoperative haemoglobin was also recorded. Data analysed by SPSS-20. RESULTS Mean of age, parity and myoma size were not statistically different between the two groups. However intraoperative blood loss (as measured by weighing and counting number of swabs used) and postoperative haemoglobin after 24 hours were significantly different between two groups with p-value <0.01. CONCLUSIONS Single dose of misoprostol given preoperatively via rectal route is effective in reducing intraoperative blood loss during abdominal myomectomy. Misoprostol must be used in different doses and routes in order to investigate its effectiveness in reducing intraoperative blood loss.",2020,Single dose of misoprostol given preoperatively via rectal route is effective in reducing intraoperative blood loss during abdominal myomectomy.,"['Fifty Patients undergoing abdominal myomectomy were selected for the study', 'abdominal myomectomy']","['Misoprostol (a uterotonic', 'Misoprostol', 'misoprostol', 'Preoperative Misoprostol', 'rectal misoprostol', 'placebo']","['Number and weight of surgical packs', 'postoperative haemoglobin', 'intraoperative blood loss', 'blood loss', 'Mean of age, parity and myoma size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",25.0,0.401997,Single dose of misoprostol given preoperatively via rectal route is effective in reducing intraoperative blood loss during abdominal myomectomy.,"[{'ForeName': 'Qudsia Qazi', 'Initials': 'QQ', 'LastName': 'Khan', 'Affiliation': 'Department of Gynaecology & Obstetrics, Lady Reading Hospital Peshawar, Pakistan.'}, {'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Liaqat', 'Affiliation': 'Department of Gynaecology & Obstetrics, Lady Reading Hospital Peshawar, Pakistan.'}, {'ForeName': 'Tanveer', 'Initials': 'T', 'LastName': 'Shafqat', 'Affiliation': 'Department of Gynaecology & Obstetrics, Lady Reading Hospital Peshawar, Pakistan.'}, {'ForeName': 'Shandana', 'Initials': 'S', 'LastName': 'Bawar', 'Affiliation': 'Department of Gynaecology & Obstetrics, Lady Reading Hospital Peshawar, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[] 2526,32584005,Direct Stenting Versus Balloon Pre-Dilatation In Elective Percutaneous Coronary Intervention.,"BACKGROUND Stents are now deployed in almost 95% of all percutaneous coronary interventions (PCIs). Recent advances in balloon and stent technology has improved the technique of direct stent (DS) strategy, i.e., stent delivery without pre-dilatation instead of conventional stenting (CS), i.e., stent implantation after balloon pre-dilatation with multiple advantages. METHODS This randomized controlled trial was conducted at the Cardiology. Department, Punjab Institute of Cardiology, Lahore from April to September, 2017. One hundred patients who were being treated by percutaneous coronary intervention (PCI) were enrolled into two Groups e.g., Group I & group II. 50 patients undergoing direct stenting were enrolled in group I and 50 patients undergoing stenting after balloon pre-dilatation were enrolled in group II after randomization. All patients were treated by single type drug eluting or bare metal stents. Chi square test was used for association and t-test for mean difference between two groups in comparison to post dilatation, fluoroscopy time, procedure time, amount of contrast used, procedural success, side branch compromise, slow flow. The p-value of ˂ 0.05 was significant. RESULTS This study consisted of 76 males and 24 females out of a total count of 100, with the average age of 52.2±0.01 years. Overall, 43 (43%) patients were diabetic and overall, 44 (44%) were hypertensive. Most of the patients 55 (55%) had PCI to LAD. Average fluoroscopy time 4.l±2.5 minutes in Group I was significantly lesser as compared to 6.7±3.8 minute group II (p-value <0.05). The average procedure time was also marginally lesser in Group I, 23.4±11.6 in comparison to the second Group 33.7±14 (p-value <0.05). Side branch compromise was observed in 10 (20%) in the first group as compared to 8 (16%) the second group. CONCLUSIONS In comparison to stenting preceded by balloon predilatation, direct stenting is a safer and more feasible procedure with respect to radiation exposure, cost and time duration of the procedure.",2020,"In comparison to stenting preceded by balloon predilatation, direct stenting is a safer and more feasible procedure with respect to radiation exposure, cost and time duration of the procedure.","['One hundred patients who were being treated by percutaneous coronary intervention (PCI', '50 patients undergoing stenting after balloon pre-dilatation', '76 males and 24 females out of a total count of 100, with the average age of 52.2±0.01 years', '50 patients undergoing']","['Direct Stenting Versus Balloon Pre-Dilatation', 'single type drug eluting or bare metal stents', 'direct stenting']","['PCI to LAD', 'Average fluoroscopy time', 'fluoroscopy time, procedure time, amount of contrast used, procedural success, side branch compromise, slow flow', 'average procedure time', 'Side branch compromise']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0457591', 'cui_str': 'Type of drug'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449900', 'cui_str': 'Contrast used'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]",50.0,0.0166475,"In comparison to stenting preceded by balloon predilatation, direct stenting is a safer and more feasible procedure with respect to radiation exposure, cost and time duration of the procedure.","[{'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Shahzad', 'Affiliation': 'Punjab Institute of Cardiology, Lahore, Ayub Teaching Hospital, Abbottabad, Pakistan.'}, {'ForeName': 'Nadeem Hayat', 'Initials': 'NH', 'LastName': 'Mallick', 'Affiliation': 'Punjab Institute of Cardiology, Lahore, Ayub Teaching Hospital, Abbottabad, Pakistan.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Punjab Institute of Cardiology, Lahore, Ayub Teaching Hospital, Abbottabad, Pakistan.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Punjab Institute of Cardiology, Lahore, Ayub Teaching Hospital, Abbottabad, Pakistan.'}, {'ForeName': 'Hazrat', 'Initials': 'H', 'LastName': 'Ullah', 'Affiliation': 'Department of Cardiology, Ayub Teaching Hospital, Abbottabad, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[] 2527,32584091,Eight-year prospective follow-up of mentalization-based treatment versus structured clinical management for people with borderline personality disorder.,"Participants ( n = 134) treated in a randomized controlled trial with mentalization-based treatment (MBT) compared with structured clinical management were followed up for 8 years after starting treatment in terms of the initial primary outcome of the trial-namely, suicide attempts, self-harm, and hospitalization-as well as service use and functional outcomes. Patients in the study group were interviewed by research assistants who remained masked to the original group allocation. Interviews were scheduled annually. Of the original participants, 98 (73%) agreed to participate. Overall, the beneficial outcomes at the end of treatment were maintained in both groups. Over the follow-up period, the number of patients who continued to meet the primary recovery criteria was significantly higher in the MBT group (74% vs. 51%). Use of most other services was comparable. Participants treated with MBT showed better functional outcomes in terms of being more likely to be engaged in purposeful activity and reporting less use of professional support services and social care interventions. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Participants treated with MBT showed better functional outcomes in terms of being more likely to be engaged in purposeful activity and reporting less use of professional support services and social care interventions.,"['Participants ( n = 134', 'Patients in the study group were interviewed by research assistants who remained masked to the original group allocation', 'people with borderline personality disorder']","['mentalization-based treatment (MBT', 'mentalization-based treatment versus structured clinical management', 'MBT']",['functional outcomes'],"[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]","[{'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0705299,Participants treated with MBT showed better functional outcomes in terms of being more likely to be engaged in purposeful activity and reporting less use of professional support services and social care interventions.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bateman', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Constantinou', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Holzer', 'Affiliation': 'Independent Practice.'}]",Personality disorders,['10.1037/per0000422'] 2528,32584117,Predicting sudden gains before treatment begins: An examination of pretreatment intraindividual variability in symptoms.,"Objective: Sudden gains during psychotherapy have been found to be predictive of positive treatment outcomes. Previous attempts at predicting occurrence of sudden gains have yielded equivocal findings. Recently, intraindividual variability in symptoms during treatment was suggested as a trans-therapeutic and trans-diagnostic predictor of sudden gains. The goal of the present study was to examine this predictor in Internet-delivered treatment for social anxiety disorder (SAD) and to examine whether this predictor predicts sudden gains when measured before treatment begins. Method: We examined data from a preregistered randomized controlled trial (RCT) of Internet-delivered cognitive-behavioral therapy (CBT) for SAD ( n = 101). We measured variability in symptoms both within-treatment and before treatment (i.e. during waitlist). Results: Intraindividual variability in symptoms significantly predicted sudden gains both when measured before treatment or within-treatment and correctly classified 84% and 83% of individuals to sudden gains versus non-sudden gains status, respectively. Conclusions: Intraindividual variability in symptoms can predict sudden gains in Internet-delivered treatment for SAD, thus supporting its trans-diagnostic and trans-therapeutic nature. Predicting sudden gains before treatment begins has implications for treatment planning and clinical decision making as well as for personalized tailoring of interventions. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Intraindividual variability in symptoms significantly predicted sudden gains both when measured before treatment or within-treatment and correctly classified 84% and 83% of individuals to sudden gains versus non-sudden gains status, respectively. ",['social anxiety disorder (SAD'],['Internet-delivered cognitive-behavioral therapy (CBT'],"['Sudden gains', 'sudden gains']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1276802', 'cui_str': 'Sudden'}]",,0.0333064,"Intraindividual variability in symptoms significantly predicted sudden gains both when measured before treatment or within-treatment and correctly classified 84% and 83% of individuals to sudden gains versus non-sudden gains status, respectively. ","[{'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Shalom', 'Affiliation': 'Department of Psychology, University of Haifa.'}, {'ForeName': 'Asher Y', 'Initials': 'AY', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linkoping University.'}, {'ForeName': 'Or D', 'Initials': 'OD', 'LastName': 'Agassi', 'Affiliation': 'Department of Psychology, University of Haifa.'}, {'ForeName': 'Idan M', 'Initials': 'IM', 'LastName': 'Aderka', 'Affiliation': 'Department of Psychology, University of Haifa.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000587'] 2529,32584124,The social transmission of overconfidence.,"We propose and test the overconfidence transmission hypothesis , which predicts that individuals calibrate their self-assessments in response to the confidence others display in their social group. Six studies that deploy a mix of correlational and experimental methods support this hypothesis. Evidence indicates that individuals randomly assigned to collaborate in laboratory dyads converged on levels of overconfidence about their own performance rankings. In a controlled experimental context, observing overconfident peers causally increased an individual's degree of bias. The transmission effect persisted over time and across task domains, elevating overconfidence even days after initial exposure. In addition, overconfidence spread across indirect social ties (person to person to person), and transmission operated outside of reported awareness. However, individuals showed a selective in-group bias; overconfidence was acquired only when displayed by a member of one's in-group (and not out-group), consistent with theoretical notions of selective learning bias. Combined, these results advance understanding of the social factors that underlie interindividual differences in overconfidence and suggest that social transmission processes may be in part responsible for why local confidence norms emerge in groups, teams, and organizations. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Evidence indicates that individuals randomly assigned to collaborate in laboratory dyads converged on levels of overconfidence about their own performance rankings.,[],[],[],[],[],[],,0.0293583,Evidence indicates that individuals randomly assigned to collaborate in laboratory dyads converged on levels of overconfidence about their own performance rankings.,"[{'ForeName': 'Joey T', 'Initials': 'JT', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Haas School of Business, University of California, Berkeley.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Tenney', 'Affiliation': 'David Eccles School of Business, University of Utah.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Brion', 'Affiliation': 'IESE Business School, University of Navarra.'}, {'ForeName': 'Don A', 'Initials': 'DA', 'LastName': 'Moore', 'Affiliation': 'Haas School of Business, University of California, Berkeley.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Logg', 'Affiliation': 'McDonough School of Business, Georgetown University.'}]",Journal of experimental psychology. General,['10.1037/xge0000787'] 2530,32584263,Determining the Impact of a School-Based Health Education Package for Prevention of Intestinal Worm Infections in the Philippines: Protocol for a Cluster Randomized Intervention Trial.,"BACKGROUND Repeated mass drug administration (MDA) of antihelminthics to at-risk populations is still the main strategy for the control of soil-transmitted helminth (STH) infections. However, MDA, as a stand-alone intervention, does not prevent reinfection. Accordingly, complementary measures to prevent STH reinfection, such as health education and improved sanitation, as part of an integrated control approach, are required to augment the effectiveness of MDA for optimal efficiency and sustainability. OBJECTIVE The aim of this study is to determine the impact and generalizability of a school-based health education package entitled The Magic Glasses for STH prevention in the Philippines. METHODS We conducted a cluster randomized controlled intervention trial, involving 2020 schoolchildren aged 9-10 years, in 40 schools in Laguna Province, Philippines, to evaluate the impact of the school-based health education package for the prevention of STHs. The trial was conducted over the course of 1 year (June 2016 to July 2017). A total of 20 schools were randomly assigned to the intervention arm, in which The Magic Glasses Philippines health education package was delivered with the standard health education activities endorsed by the Philippines Department of Health (DOH) and the Department of Education (DepEd). The other 20 schools comprised the control arm of the study, where the DOH/DepEd's standard health education activities were done. At baseline, parasitological assessments and a knowledge, attitude, and practice survey were carried out in all schools. In addition, height, weight, and hemoglobin levels were obtained from each child (after parental consent), and their school attendance and academic performance in English and mathematics were accessed from the school records. The baseline and 2 follow-up surveys were completed using the same study measurements and quality-control assessments. RESULTS Key results from this cluster randomized intervention trial will shed light on the impact that The Magic Glasses health education package will have against STH infections in schoolchildren in the province of Laguna, located on the Island of Luzon, in the Calabarzon Region of the Philippines. CONCLUSIONS The results of the trial will be used to assess the generalizability of the impact of The Magic Glasses health education package in different epidemiological and cultural settings, providing evidence for translation of this health education package into public health policy and practice in the Asian region and beyond. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry number ACTRN12616000508471; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368849. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/18419.",2020,"The results of the trial will be used to assess the generalizability of the impact of The Magic Glasses health education package in different epidemiological and cultural settings, providing evidence for translation of this health education package into public health policy and practice in the Asian region and beyond. ","['A total of 20 schools', '2020 schoolchildren aged 9-10 years, in 40 schools in Laguna Province, Philippines, to evaluate the impact of the school-based health education package for the prevention of STHs']","['School-Based Health Education Package', 'Magic Glasses Philippines health education package was delivered with the standard health education activities endorsed by the Philippines Department of Health (DOH) and the Department of Education (DepEd']","['height, weight, and hemoglobin levels', 'school attendance and academic performance in English and mathematics']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C3529285', 'cui_str': 'Magic Glass'}, {'cui': 'C4705263', 'cui_str': 'philippin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}]",20.0,0.0954268,"The results of the trial will be used to assess the generalizability of the impact of The Magic Glasses health education package in different epidemiological and cultural settings, providing evidence for translation of this health education package into public health policy and practice in the Asian region and beyond. ","[{'ForeName': 'Mary Lorraine S', 'Initials': 'MLS', 'LastName': 'Mationg', 'Affiliation': 'Research School of Population Heath, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Williams', 'Affiliation': 'School of Public Health, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Veronica L', 'Initials': 'VL', 'LastName': 'Tallo', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Eindra', 'Initials': 'E', 'LastName': 'Aung', 'Affiliation': 'Research School of Population Heath, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Portia', 'Initials': 'P', 'LastName': 'Alday', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Mark Donald', 'Initials': 'MD', 'LastName': 'Reñosa', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Chona Mae', 'Initials': 'CM', 'LastName': 'Daga', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jhoys', 'Initials': 'J', 'LastName': 'Landicho', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Maria Paz', 'Initials': 'MP', 'LastName': 'Demonteverde', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Eunice Dianne', 'Initials': 'ED', 'LastName': 'Santos', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Thea Andrea', 'Initials': 'TA', 'LastName': 'Bravo', 'Affiliation': 'Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Franziska A', 'Initials': 'FA', 'LastName': 'Angly Bieri', 'Affiliation': 'Research School of Population Heath, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Yuesheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Archie C A', 'Initials': 'ACA', 'LastName': 'Clements', 'Affiliation': 'Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Steinmann', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Halton', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Stewart', 'Affiliation': 'Research School of Population Heath, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'McManus', 'Affiliation': 'Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Darren J', 'Initials': 'DJ', 'LastName': 'Gray', 'Affiliation': 'Research School of Population Heath, The Australian National University, Canberra, Australia.'}]",JMIR research protocols,['10.2196/18419'] 2531,32584276,A Comparative Assessment of the Management of Mandibular Angle Fractures Using 3D Plates and 2D Miniplates.,"AIMS The aim of this study was to compare 2D plates with 3D miniplate system in the management of mandibular angle fractures. MATERIALS AND METHODS The study was conducted on 146 patients with mandibular angle fracture, who were equally divided into two groups of 73. Patients in group I were treated with 3D plating and in group II with 2D plating. In all cases, 2.0 mm titanium miniplates were used. The etiology of fracture, amount of mouth opening, and pain and sensory deficit were recorded. Clinical and radiographic assessment was done at 1, 3, and 6 months. RESULTS The etiology of mandibular angle fracture is roadside accident (RSA) seen in 110 (75.3%) cases, fall in 24 (16.4%), and assault in 12 (2.6%) cases. There was significant ( p < 0.05) mouth opening in group I at 1 month postoperatively (32.4 mm) as compared to group II (27.5 mm), at 3 months in group I (33.6 mm) as compared to group II (30.2 mm), and at 6 months in group I (36.4 mm) as compared to group II (31.6 mm). After 1 month, sensory deficit was present in six patients in group I and 10 patients in group II. After 3 months, group I had no patients and three patients in group II. Right angle fracture was found in 71 patients (group I-36, group II-35). Mandibular right angle fracture in 58 patients (group I-28, group II-30). CONCLUSION The authors found that the 3D miniplate system is more useful in the management of cases of mandibular angle fracture as compared to 2D miniplates. CLINICAL SIGNIFICANCE There has been increase in mandibular fractures in the last few years. Appropriate management with 3D miniplates may be useful in providing better treatment outcomes.",2020,"There was significant ( p < 0.05) mouth opening in group I at 1 month postoperatively (32.4 mm) as compared to group II (27.5 mm), at 3 months in group I (33.6 mm) as compared to group II (30.2 mm), and at 6 months in group I (36.4 mm) as compared to group II (31.6 mm).","['58 patients (group I-28, group II-30', '146 patients with mandibular angle fracture, who were equally divided into two groups of 73']",[],"['sensory deficit', 'Right angle fracture', 'mandibular fractures', 'etiology of fracture, amount of mouth opening, and pain and sensory deficit', 'Mandibular right angle fracture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]",[],"[{'cui': 'C0748618', 'cui_str': 'Sensory deficit'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]",146.0,0.0204353,"There was significant ( p < 0.05) mouth opening in group I at 1 month postoperatively (32.4 mm) as compared to group II (27.5 mm), at 3 months in group I (33.6 mm) as compared to group II (30.2 mm), and at 6 months in group I (36.4 mm) as compared to group II (31.6 mm).","[{'ForeName': 'Revati', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Dentistry, Patna Dental College and Hospital, Patna, Bihar, India, Phone: +91 8210356292, e-mail: revateesingh@gmail.com.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Prosthodontics, Crown, Bridge and Implantology, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Cheranjeevi', 'Initials': 'C', 'LastName': 'Jayam', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh, India.'}, {'ForeName': 'Jazib', 'Initials': 'J', 'LastName': 'Nazeer', 'Affiliation': 'Department of Oral Pathology, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Iqubal', 'Affiliation': 'Department of Oral Medicine and Radiology, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Private Practitioner, Department of Oral Medicine and Radiology, Patna, Bihar, India.'}]",The journal of contemporary dental practice,[] 2532,32584279,"Comparative Assessment between Ibuprofen, Chewing Gum, and Bite Wafers in Pain Control Following First Archwire Placement in Orthodontic Patients.","PURPOSE This study aimed to investigate the effectiveness of using bite wafers and chewing gum in relieving pain after the activation of the first archwire among Saudi orthodontic patients and evaluating them in comparison with ibuprofen use. Furthermore, the study investigated the effect of chewing gum and plastic wafers on the frequency of orthodontic appliance breakage. MATERIALS AND METHODS A total of 105 female patients aged 15-35 years, undergoing maxillary and mandibular fixed appliance treatment were classified randomly into three groups of 35 each. In each group, the patients were given one of the following treatments immediately after the placement of the first archwire, every 8 hours for 1 week as needed: ibuprofen (400 mg), or a viscoelastic bite wafer, or chewing gum. A visual analog scale was given to the patients to record their pain perception following initial archwire placement. In addition, the patients were asked to report any incidence of detached brackets while using the above methods. Data were analyzed using analysis of variance (ANOVA). RESULTS No statistically significant differences were found in pain perception at any time interval among the three groups. The pain experienced at bedtime and 24 hours after wire placement among different groups in the present study was found to be slightly higher with maximum intensity and the pain perception finding at different time intervals within each pain relief method was statistically significant ( p = 0.000, p < 0.05). Furthermore, ANOVA results demonstrate no significant differences in bracket detachment between the groups ( p = 0.20, p < 0.05). CONCLUSION The use of bite wafers and chewing gum was effective and comparable to ibuprofen use for pain relief following the initial activation of fixed orthodontic appliances among Saudi orthodontic patients. In addition, the study found no clinically or statistically significant differences in bracket detachment between the groups. CLINICAL SIGNIFICANCE The nondrug modalities of controlling pain such as chewing gum and/or bite wafers can be used as an alternative to ibuprofen use following the first activation of fixed orthodontic appliances.",2020,The use of bite wafers and chewing gum was effective and comparable to ibuprofen use for pain relief following the initial activation of fixed orthodontic appliances among Saudi orthodontic patients.,"['Saudi orthodontic patients and evaluating them in comparison with ibuprofen use', 'Saudi orthodontic patients', '105 female patients aged 15-35 years, undergoing maxillary and mandibular fixed appliance treatment', 'Orthodontic Patients']","['viscoelastic bite wafer, or chewing gum', 'bite wafers and chewing gum', 'Ibuprofen, Chewing Gum, and Bite Wafers', 'ibuprofen']","['pain relief', 'maximum intensity and the pain perception', 'pain', 'bracket detachment', 'pain perception']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0991560', 'cui_str': 'Oral Wafer'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}]",105.0,0.0157747,The use of bite wafers and chewing gum was effective and comparable to ibuprofen use for pain relief following the initial activation of fixed orthodontic appliances among Saudi orthodontic patients.,"[{'ForeName': 'Eman I', 'Initials': 'EI', 'LastName': 'Al Shayea', 'Affiliation': 'Division of Orthodontics, Department of Pediatric Dentistry and Orthodontics, College of Dentistry, King Saud University, Riyadh, Kingdom of Saudi Arabia, Phone: +966 505420838, e-mail: e_shayea@hotmail.com.'}]",The journal of contemporary dental practice,[] 2533,32584281,"Dentin Conditioning Using Different Laser Prototypes (Er,Cr:YSGG; Er:YAG) on Bond Assessment of Resin-modified Glass Ionomer Cement.","AIM The aim of this study was to evaluate and compare various conditioning regimes (laser and conventional) on shear bond strength (SBS) of resin-modified glass ionomer cement (RMGIC) bonded to dentin. MATERIALS AND METHODS Sixty non-carious intact maxillary molars were cleaned, isolated, and randomly divided into six groups ( n = 10). Before randomization, the dentin surface was exposed and finished. Samples in group I were conditioned using Er,Cr:YSGG laser (ECYL). Specimens in group II were conditioned using Er:YAG laser (EYL), and the dentin surfaces of specimens in group III and group IV were conditioned using cavity conditioner and K930. Similarly, the samples in group V and group VI were surface treated using 17% EDTA and total etch. All samples were bonded with RMGIC following conditioning regime. For SBS testing, the samples were placed in universal testing machine. A fracture analysis of debonded surfaces was evaluated using stereomicroscope at 40× magnification. Means and standard deviations (SDs) were calculated using analysis of variance (ANOVA) and Tukey's post hoc test at a significant level of p < 0.05. RESULTS The maximum bond strength values were observed in group VI total etch (23.85 ± 3.67). The lowest bond strength was displayed in laser dentin group II conditioned by EYL (11.65 ± 2.77). Dentin conditioned with ECYL, cavity conditioner, K930 conditioner, and 17% ethylenediaminetetraacetic acid (EDTA) were found to be comparable, p > 0.05. Cohesive failure was dominant among experimental groups. CONCLUSION Er,Cr:YSGG laser has a potential to be recommended for dentin conditioning prior to application of RMGIC. CLINICAL SIGNIFICANCE Dentin conditioning enhances adhesion of RMGIC for improved prognosis and treatment outcome.",2020,The lowest bond strength was displayed in laser dentin group II conditioned by EYL (11.65 ± 2.77).,"['Sixty non-carious intact maxillary molars', 'Resin-modified Glass Ionomer Cement']","['various conditioning regimes (laser and conventional', 'Dentin Conditioning Using Different Laser Prototypes', 'conditioned using Er:YAG laser (EYL', 'ethylenediaminetetraacetic acid (EDTA', 'Er,Cr', 'I were conditioned using Er,Cr:YSGG laser (ECYL', 'YSGG', 'YSGG laser']","['maximum bond strength values', 'shear bond strength (SBS', 'Means and standard deviations (SDs', 'lowest bond strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",60.0,0.0338134,The lowest bond strength was displayed in laser dentin group II conditioned by EYL (11.65 ± 2.77).,"[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alkhudhairy', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Saud University, Riyadh, Kingdom of Saudi Arabia, Phone: +966 559917888, e-mail: falkhudhairy@ksu.edu.sa.'}]",The journal of contemporary dental practice,[] 2534,32584519,Development and assessment of a formal learning module to educate veterinary students in an intensive care unit about transfusion reactions.,"OBJECTIVE To develop and assess the instructional efficacy of an online learning module on transfusion reactions in small animals and to evaluate participants' satisfaction of the module. DESIGN Randomized controlled trial. SETTING University teaching hospital. SUBJECTS A total of 55, fourth-year veterinary students, 27 in a treatment group that received the learning module plus standard rotation training and 28 in a control group (no module) who received only standard training INTERVENTIONS: Students received a pretest on transfusion reactions followed by administration of a transfusion reaction learning module covering recognition, treatment, prevention, case examples, and self-assessment questions for 6 common transfusion reactions. Students also received a module satisfaction survey, a post-test at 2 weeks post-module, and a retention test at 6 weeks post-module. MEASUREMENTS AND MAIN RESULTS Previous transfusion medicine exposure did not affect pretest scores and there was no difference in pretest scores between groups. The module group scored higher on the post-test (P < 0.001) and retention test (P = 0.002) than the control group. Mean post-test scores were 74.4% and 57.7% and mean retention test scores were 80.6% and 56.5% for the module and control groups, respectively. The module group scored higher on posttest and retention questions involving reaction recognition (P < 0.001). Students were overall very satisfied with the module with an average score of 4.8 (1-5). CONCLUSIONS A transfusion reaction instructional module can be delivered successfully to veterinary students on an ICU-based clinical rotation. Students taking the module scored significantly better on post-assessments up to 6 weeks after module administration as compared to students receiving only conventional clinical rotation training.",2020,The module group scored higher on the post-test (P < 0.001) and retention test (P = 0.002) than the control group.,"['educate veterinary students in an intensive care unit about transfusion reactions', 'University teaching hospital']","['online learning module', 'conventional clinical rotation training', 'learning module plus standard rotation training and 28 in a control group (no module) who received only standard training']","['posttest and retention questions involving reaction recognition', 'retention test', 'Mean post-test scores', 'mean retention test scores', 'transfusion reactions', 'instructional efficacy']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",55.0,0.0618456,The module group scored higher on the post-test (P < 0.001) and retention test (P = 0.002) than the control group.,"[{'ForeName': 'Jillian M', 'Initials': 'JM', 'LastName': 'Haines', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'K Jane', 'Initials': 'KJ', 'LastName': 'Wardrop', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindberg', 'Affiliation': 'Oregon State University Extended Campus, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Kira J', 'Initials': 'KJ', 'LastName': 'Carbonneau', 'Affiliation': 'Department of Educational Leadership, Sports Sciences, and Educational Psychology, College of Education, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'Thandeka R', 'Initials': 'TR', 'LastName': 'Ngwenyama', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}, {'ForeName': 'Linda G', 'Initials': 'LG', 'LastName': 'Martin', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, Washington, USA.'}]","Journal of veterinary emergency and critical care (San Antonio, Tex. : 2001)",['10.1111/vec.12983'] 2535,32579432,Does Happiness Improve Health? Evidence From a Randomized Controlled Trial.,"Happier people are healthier, but does becoming happier lead to better health? In the current study, we deployed a comprehensive, 3-month positive psychological intervention as an experimental tool to examine the effects of increasing subjective well-being on physical health in a nonclinical population. In a 6-month randomized controlled trial with 155 community adults, we found effects of treatment on self-reported physical health-the number of days in the previous month that participants felt healthy or sick, as assessed by questions from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System Questionnaire. In a subsample of 100 participants, we also found evidence that improvements in subjective well-being over the course of the program predicted subsequent decreases in the number of sick days. Combining experimental and longitudinal methodologies, this work provides some evidence for a causal effect of subjective well-being on self-reported physical health.",2020,"Happier people are healthier, but does becoming happier lead to better health?","[""participants felt healthy or sick, as assessed by questions from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System Questionnaire"", '155 community adults']",[],['number of sick days'],"[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C1136355', 'cui_str': 'Behavior Risk Factor Surveillance System'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242806', 'cui_str': 'Illness Days'}]",155.0,0.0428741,"Happier people are healthier, but does becoming happier lead to better health?","[{'ForeName': 'Kostadin', 'Initials': 'K', 'LastName': 'Kushlev', 'Affiliation': 'Department of Psychology, Georgetown University.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Heintzelman', 'Affiliation': 'Department of Psychology, Rutgers University, Newark.'}, {'ForeName': 'Lesley D', 'Initials': 'LD', 'LastName': 'Lutes', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Wirtz', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Kanippayoor', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Leitner', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Diener', 'Affiliation': 'Department of Psychology, University of Virginia.'}]",Psychological science,['10.1177/0956797620919673'] 2536,32579483,Protective effect of dexmedetomidine infusion combined with epidural blockade on postoperative complications after surgery: A prospective randomized controlled clinical trial.,"OBJECTIVES This prospective, randomized, controlled study aimed to explore the efficacy of dexmedetomidine combined with epidural blockade on postoperative recovery of elderly patients after radical resection for colorectal cancer. METHODS Ninety-six elderly patients who underwent radical resection for colorectal cancer were randomly divided into the following four groups: dexmedetomidine, epidural blockade (ropivacaine), combined (dexmedetomidine + epidural blockade), and control (0.9% saline). The Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS), and Ramsay scores at 48 hours, and time to first activity, length of hospital stay, and postoperative complication rates at 3 months were assessed. RESULTS Twelve hours after surgery, Ramsay scores were higher in the combined compared with the control and epidural blockade groups. Twenty-four hours after surgery, MMSE scores were higher in the combined compared with the other groups. The combined group showed the lowest VAS scores except at 48 hours. Time to first activity and length of hospital stay were significantly shorter in the combined compared with the other groups. There was no difference in total postoperative complication rates among the groups. CONCLUSIONS A combination of intraoperative dexmedetomidine infusion and epidural blockade could mitigate pain after surgery, improve cognitive dysfunction in early surgery, and facilitate recovery.",2020,"There was no difference in total postoperative complication rates among the groups. ","['elderly patients after radical resection for colorectal cancer', 'for colorectal cancer', 'Ninety-six elderly patients who underwent', 'after surgery']","['dexmedetomidine combined with epidural blockade', 'dexmedetomidine, epidural blockade (ropivacaine), combined (dexmedetomidine\u2009+\u2009epidural blockade), and control (0.9% saline', 'dexmedetomidine infusion combined with epidural blockade', 'radical resection', 'intraoperative dexmedetomidine infusion and epidural blockade']","['MMSE scores', 'lowest VAS scores', 'cognitive dysfunction', 'postoperative complications', 'total postoperative complication rates', 'Time to first activity and length of hospital stay', 'Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS), and Ramsay scores at 48 hours, and time to first activity, length of hospital stay, and postoperative complication rates', 'Ramsay scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]",96.0,0.113406,"There was no difference in total postoperative complication rates among the groups. ","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520930168'] 2537,32579549,"A novel nutritional supplement containing amino acids and chromium decreases postprandial glucose response in a randomized, double-blind, placebo-controlled study.","High postprandial blood glucose levels are associated with increased mortality, cardiovascular events and development of diabetes in the general population. Interventions targeting postprandial glucose have been shown to prevent both cardiovascular events and diabetes. This study evaluates the efficacy and safety of a novel nutritional supplement targeting postprandial glucose excursions in non-diabetic adults. Sixty overweight healthy male and female participants were recruited at two centers and randomized in a double-blind, placebo-controlled, crossover design. The supplement, a water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal. The primary endpoint was the incremental area under the curve (iAUC) for venous blood glucose from 0 to 120 minutes. Secondary endpoints included glucose iAUC 0-180 minutes and the maximum glucose concentration (Cmax), for both venous and capillary blood glucose. In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017). The Cmax for venous blood glucose for the supplement and placebo were 6.45 (0.12) versus 6.10 (<0.12), respectively, a difference of -0.35 mmol/L (95% CI -0.17 to -0.53, p<0.001). In the per protocol-analysis (n = 48), the supplement resulted in a decreased Cmax compared to placebo from 6.42 (0.14) to 6.12 (0.14), a difference of -0.29 mmol/L (95% CI -0.12 to -0.47, p = 0.002). No significant differences in capillary blood glucose were found, as measured by regular bed-side glucometers. The nutritional supplement drink containing amino acids and chromium improves the postprandial glucose homeostasis in overweight adults without diabetes. Future studies should clarify, whether regular consumption of the supplement improves markers of disease or could play a role in a diet aiming at preventing the development of diabetes.",2020,"In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017).","['Sixty overweight healthy male and female participants', 'non-diabetic adults', 'overweight adults without diabetes']","['novel nutritional supplement targeting postprandial glucose excursions', 'nutritional supplement drink containing amino acids and chromium', 'water-based drink containing 2.6g of amino acids (L-Leucine, L-Threonine, L-Lysine Monohydrochloride, L-Isoleucine, L-Valine) and 250 mcg of chromium picolinate, was consumed with a standardized carbohydrate-rich meal', 'amino acids and chromium', 'placebo']","['glucose iAUC 0-180 minutes and the maximum glucose concentration (Cmax), for both venous and capillary blood glucose', 'High postprandial blood glucose levels', 'capillary blood glucose', 'incremental area under the curve (iAUC) for venous blood glucose', 'Cmax for venous blood glucose', 'efficacy and safety', 'postprandial glucose homeostasis', 'postprandial glucose response', 'mortality, cardiovascular events and development of diabetes', 'venous blood glucose iAUC0-120min']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",60.0,0.255059,"In the intention-to-treat-analysis (n = 60) the supplement resulted in a decreased venous blood glucose iAUC0-120min compared to placebo, mean (SE) of 68.7 (6.6) versus 52.2 (6.8) respectively, a difference of -16.5 mmol/L•min (95% CI -3.1 to -30.0, p = 0.017).","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Östman', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Azat', 'Initials': 'A', 'LastName': 'Samigullin', 'Affiliation': 'StarScience GmbH, Heidelberg, Germany.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Heyman-Lindén', 'Affiliation': 'Aventure AB, Lund, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Andersson', 'Affiliation': 'Aventure AB, Lund, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Björck', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Öste', 'Affiliation': 'Food for Health Science Center, Lund University, Lund, Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Humpert', 'Affiliation': 'StarScience GmbH, Heidelberg, Germany.'}]",PloS one,['10.1371/journal.pone.0234237'] 2538,32579813,Hydroxyurea Dose Escalation for Sickle Cell Anemia in Sub-Saharan Africa.,"BACKGROUND Hydroxyurea has proven safety, feasibility, and efficacy in children with sickle cell anemia in sub-Saharan Africa, with studies showing a reduced incidence of vaso-occlusive events and reduced mortality. Dosing standards remain undetermined, however, and whether escalation to the maximum tolerated dose confers clinical benefits that outweigh treatment-related toxic effects is unknown. METHODS In a randomized, double-blind trial, we compared hydroxyurea at a fixed dose (approximately 20 mg per kilogram of body weight per day) with dose escalation (approximately 30 mg per kilogram per day). The primary outcome was a hemoglobin level of 9.0 g or more per deciliter or a fetal hemoglobin level of 20% or more after 24 months. Secondary outcomes included the incidences of malaria, vaso-occlusive crises, and serious adverse events. RESULTS Children received hydroxyurea at a fixed dose (94 children; mean [±SD] age, 4.6±1.0 years) or with dose escalation (93 children; mean age, 4.8±0.9 years); the mean doses were 19.2±1.8 mg per kilogram per day and 29.5±3.6 mg per kilogram per day, respectively. The data and safety monitoring board halted the trial when the numbers of clinical events were significantly lower among children receiving escalated dosing than among those receiving a fixed dose. At trial closure, 86% of the children in the dose-escalation group had reached the primary-outcome thresholds, as compared with 37% of the children in the fixed-dose group (P<0.001). Children in the dose-escalation group had fewer sickle cell-related adverse events (incidence rate ratio, 0.43; 95% confidence interval [CI], 0.34 to 0.54), vaso-occlusive pain crises (incidence rate ratio, 0.43; 95% CI, 0.34 to 0.56), cases of acute chest syndrome or pneumonia (incidence rate ratio, 0.27; 95% CI, 0.11 to 0.56), transfusions (incidence rate ratio, 0.30; 95% CI, 0.20 to 0.43), and hospitalizations (incidence rate ratio, 0.21; 95% CI, 0.13 to 0.34). Laboratory-confirmed dose-limiting toxic effects were similar in the two groups, and there were no cases of severe neutropenia or thrombocytopenia. CONCLUSIONS Among children with sickle cell anemia in sub-Saharan Africa, hydroxyurea with dose escalation had superior clinical efficacy to that of fixed-dose hydroxyurea, with equivalent safety. (Funded by the Doris Duke Charitable Foundation and the Cincinnati Children's Research Foundation; NOHARM MTD ClinicalTrials.gov number, NCT03128515.).",2020,"Laboratory-confirmed dose-limiting toxic effects were similar in the two groups, and there were no cases of severe neutropenia or thrombocytopenia. ","['children with sickle cell anemia in sub-Saharan Africa', 'Sickle Cell Anemia in Sub-Saharan Africa']","['Hydroxyurea Dose Escalation', 'hydroxyurea', 'Hydroxyurea']","['vaso-occlusive pain crises', 'incidences of malaria, vaso-occlusive crises, and serious adverse events', 'acute chest syndrome or pneumonia', 'Laboratory-confirmed dose-limiting toxic effects', 'hemoglobin level of 9.0 g or more per deciliter or a fetal hemoglobin level', 'severe neutropenia or thrombocytopenia', 'sickle cell-related adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0742343', 'cui_str': 'Acute chest syndrome'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0200695', 'cui_str': 'Fetal hemoglobin determination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}]",,0.524197,"Laboratory-confirmed dose-limiting toxic effects were similar in the two groups, and there were no cases of severe neutropenia or thrombocytopenia. ","[{'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Teresa S', 'Initials': 'TS', 'LastName': 'Latham', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Hume', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Nabaggala', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Kasirye', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Ndugwa', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Ware', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa2000146'] 2539,32579811,Effects of Allopurinol on the Progression of Chronic Kidney Disease.,"BACKGROUND Elevated serum urate levels are associated with progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease who are at risk for progression is not known. METHODS In this randomized, controlled trial, we randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2 of body-surface area in the preceding year to receive allopurinol (100 to 300 mg daily) or placebo. The primary outcome was the change in eGFR from randomization to week 104, calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation. RESULTS Enrollment was stopped because of slow recruitment after 369 of 620 intended patients were randomly assigned to receive allopurinol (185 patients) or placebo (184 patients). Three patients per group withdrew immediately after randomization. The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter) were included in the assessment of the primary outcome. The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2 per year [95% confidence interval {CI}, -4.11 to -2.55] and -3.23 ml per minute per 1.73 m 2 per year [95% CI, -3.98 to -2.47], respectively; mean difference, -0.10 ml per minute per 1.73 m 2 per year [95% CI, -1.18 to 0.97]; P = 0.85). Serious adverse events were reported in 84 of 182 patients (46%) in the allopurinol group and in 79 of 181 patients (44%) in the placebo group. CONCLUSIONS In patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with allopurinol did not slow the decline in eGFR as compared with placebo. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; CKD-FIX Australian New Zealand Clinical Trials Registry number, ACTRN12611000791932.).",2020,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2 per year [95% confidence interval {CI}, -4.11 to -2.55] and","['patients with chronic kidney disease who are at risk for progression is not known', 'patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with', 'The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter', 'Enrollment was stopped because of slow recruitment after 369 of 620 intended patients', 'randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2 of body-surface area in the preceding year to receive']","['placebo', 'allopurinol', 'Allopurinol']","['Chronic Kidney Disease Epidemiology Collaboration creatinine equation', 'glomerular filtration rate (eGFR', 'change in eGFR', 'Progression of Chronic Kidney Disease', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C4552444', 'cui_str': 'Estimated glomerular filtration rate decreased'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",620.0,0.744268,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2 per year [95% confidence interval {CI}, -4.11 to -2.55] and","[{'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Anushree', 'Initials': 'A', 'LastName': 'Tiku', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Brown', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Douglas', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Faull', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Harris', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Graham R D', 'Initials': 'GRD', 'LastName': 'Jones', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kanellis', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Suetonia C', 'Initials': 'SC', 'LastName': 'Palmer', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Gopala K', 'Initials': 'GK', 'LastName': 'Rangan', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915833'] 2540,32579812,Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,"BACKGROUND The effects on patient safety of eliminating extended-duration work shifts for resident physicians remain controversial. METHODS We conducted a multicenter, cluster-randomized, crossover trial comparing two schedules for pediatric resident physicians during their intensive care unit (ICU) rotations: extended-duration work schedules that included shifts of 24 hours or more (control schedules) and schedules that eliminated extended shifts and cycled resident physicians through day and night shifts of 16 hours or less (intervention schedules). The primary outcome was serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review. RESULTS The characteristics of ICU patients during the two work schedules were similar, but resident physician workload, described as the mean (±SD) number of ICU patients per resident physician, was higher during the intervention schedules than during the control schedules (8.8±2.8 vs. 6.7±2.2). Resident physicians made more serious errors during the intervention schedules than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53; 95% confidence interval [CI], 1.37 to 1.72; P<0.001). The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71). There was wide variability among sites, however; errors were lower during intervention schedules than during control schedules at one site, rates were similar during the two schedules at two sites, and rates were higher during intervention schedules than during control schedules at three sites. In a secondary analysis that was adjusted for the number of patients per resident physician as a potential confounder, intervention schedules were no longer associated with an increase in errors. CONCLUSIONS Contrary to our hypothesis, resident physicians who were randomly assigned to schedules that eliminated extended shifts made more serious errors than resident physicians assigned to schedules with extended shifts, although the effect varied by site. The number of ICU patients cared for by each resident physician was higher during schedules that eliminated extended shifts. (Funded by the National Heart, Lung, and Blood Institute; ROSTERS ClinicalTrials.gov number, NCT02134847.).",2020,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).",['pediatric resident physicians during their intensive care unit (ICU) rotations'],[],"['number of serious errors unitwide', 'errors', 'serious errors', 'serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0376531', 'cui_str': 'Errors, Medical'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}]",,0.0840156,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sanderson', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Qadri', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'St Hilaire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Segar', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'McGuire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Horacio O', 'Initials': 'HO', 'LastName': 'de la Iglesia', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900669'] 2541,32584367,Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial.,"Importance ERBB2 (HER2)-targeted therapy provides benefits in metastatic breast cancer (mBC) and gastric cancer, but additional treatments are needed to maximize efficacy and quality of life. Objective To determine maximum tolerated doses (MTDs) of trastuzumab emtansine (T-DM1) plus capecitabine in patients with previously treated ERBB2-positive mBC and locally advanced/metastatic gastric cancer (LA/mGC) (phase 1) and the efficacy and safety of this combination vs T-DM1 alone in patients with mBC (phase 2). Design, Setting, and Participants The MTD in phase 1 was assessed using a 3 + 3 design with capecitabine dose modification. Phase 2 was an open-label, randomized, international multicenter study of patients with mBC treated with T-DM1 plus capecitabine or T-DM1 alone. Eligible patients had previously treated ERBB2-positive mBC or LA/mGC with no prior chemotherapy treatment for advanced disease. Interventions Patients in the phase 1 mBC cohort received capecitabine (750 mg/m2, 700 mg/m2, or 650 mg/m2 twice daily, days 1-14 of a 3-week cycle) plus T-DM1 3.6 mg/kg every 3 weeks. Patients with LA/mGC received capecitabine at the mBC phase 1 MTD, de-escalating as needed, plus T-DM1 2.4 mg/kg weekly. In phase 2, patients with mBC were randomized (1:1) to receive capecitabine (at the phase 1 MTD) plus T-DM1 or T-DM1 alone. Main Outcomes and Measures The phase 1 primary objective was to identify the MTD of capecitabine plus T-DM1. The phase 2 primary outcome was investigator-assessed overall response rate (ORR). Results In phase 1, the median (range) age was 54.0 (37-71) and 57.5 (53-70) years for patients with mBC and patients with LA/mGC, respectively. The capecitabine MTD was identified as 700 mg/m2 in 11 patients with mBC and 6 patients with LA/mGC evaluable for dose-limiting toxic effects. In phase 2, between October 2014 and April 2016, patients with mBC (median [range] age, 52.0 [28-80] years) were randomized to receive combination therapy (n = 81) or T-DM1 (n = 80). The ORR was 44% (36 of 81 patients) and 36% (29 of 80 patients) in the combination and T-DM1 groups, respectively (difference, 8.2%; 90% CI, -4.5 to 20.9; P = .34; clinical cutoff, May 31, 2017). Adverse events (AEs) were reported in 78 of 82 patients (95%) in the combination group, with 36 (44%) experiencing grade 3-4 AEs, and 69 of 78 patients (88%) in the T-DM1 group, with 32 (41%) experiencing grade 3-4 AEs. No grade 5 AEs were reported. Conclusions and Relevance Adding capecitabine to T-DM1 did not statistically increase ORR associated with T-DM1 in patients with previously treated ERBB2-positive mBC. The combination group reported more AEs, but with no unexpected toxic effects. Trial Registration ClinicalTrials.gov Identifier: NCT01702558.",2020,"No grade 5 AEs were reported. ","['patients with previously treated ERBB2-positive mBC and locally advanced/metastatic gastric cancer (LA/mGC', 'patients with previously treated ERBB2-positive mBC', 'patients with mBC treated with', 'patients with mBC (phase 2', 'Eligible patients had previously treated ERBB2-positive mBC or LA/mGC with no prior chemotherapy treatment for advanced disease', 'HER2)-Positive Metastatic Breast Cancer', 'In phase 2, between October 2014 and April 2016, patients with mBC (median [range] age, 52.0 [28-80] years', 'metastatic breast cancer (mBC) and gastric cancer', 'Patients With Previously Treated ERBB2', 'patients with mBC']","['HER2)-targeted therapy', 'combination therapy', 'capecitabine (at the phase 1 MTD) plus T-DM1 or T-DM1 alone', 'T-DM1 plus capecitabine or T-DM1 alone', 'capecitabine MTD', 'capecitabine', 'trastuzumab emtansine (T-DM1) plus capecitabine', 'Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone']","['Efficacy and Safety', 'investigator-assessed overall response rate (ORR', 'Importance\n\n\nERBB2', 'ORR', 'efficacy and safety', 'Adverse events (AEs', 'toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.170456,"No grade 5 AEs were reported. ","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'Quirónsalud Group, IOB Institute of Oncology, Madrid, Spain.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Hematology/Medical Oncology, 3rd Department of Internal Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montemurro', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Riera-Knorrenschild', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Immunologie, Universitätsklinikum Gießen und Marburg, Standort Marburg, Philipps-Universität Marburg, Baldingerstraße, Marburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Department of Haematology, Oncology and Tumorimmunology, Campus Virchow-Klinikum, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Allegrini', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Pontedera Hospital, Azienda L Toscana Nord Ovest, Pisa, Italy.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Division of Breast Medical Oncology, Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Napoli, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lohrisch', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Oravcová', 'Affiliation': '2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Perez-Garcia', 'Affiliation': 'Quirónsalud Group, IOB Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Sakaeva', 'Affiliation': 'Department of Chemotherapy, Republican Clinical Oncology Center, Ufa, Russia.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Serpanchy', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Šufliarský', 'Affiliation': '2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Irahara', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wohlfarth', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Aout', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1796'] 2542,32584384,Association of Intravitreal Aflibercept With Optical Coherence Tomography Angiography Vessel Density in Patients With Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.,"Importance Although previous studies have evaluated the association between anti-vascular endothelial growth factor therapy and macular vessel density, they were confounded by the presence of macular edema, which may be associated with artifacts and segmentation errors in optical coherence tomography angiography (OCTA). Objective To evaluate the association of intravitreal aflibercept with changes in macular vascular density using OCTA in patients with proliferative diabetic retinopathy without diabetic macular edema. Design, Setting, and Participants This post hoc analysis of a randomized clinical trial used data on 40 eyes of 40 patients with proliferative diabetic retinopathy without diabetic macular edema who were enrolled in the Intravitreal Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy (RECOVERY) clinical trial from August 1, 2016, to June 31, 2017. Three patients were lost to follow-up at month 12, and 5 patients were excluded from analysis because of poor OCTA image quality, leaving 16 patients in each cohort in the final analysis. Data analysis was performed from March 1, 2018, to January 15, 2019. Intervention In the RECOVERY trial, patients were randomized into cohorts receiving 2 mg of aflibercept injections monthly (n = 20) or quarterly (n = 20) and treated for 12 months. Main Outcomes and Measures The percentage of vascular density (in total scan and foveal and parafoveal regions) was compared before and after 12 months of therapy. Results The sample for this OCTA analysis included 32 eyes from 32 patients (mean [SD] age, 48.37 [12.30] years; 17 [53.1%] male). The mean (SD) total scan vascular density for the superficial vascular complex was 42.28% (4.03%; 95% CI, 40.63%-43.93%) at baseline and 39.64% (4.01%; 95% CI, 37.91%-41.37%) at month 12 (P = .69). For the deep vascular complex, the mean (SD) vascular density was 48.42% (4.99%; 95% CI, 46.36%-50.47%) at baseline and 45.69% (4.63%; 95% CI, 43.69%-47.70%) at month 12 (P = .40). For the choriocapillaris, the mean (SD) vascular density was 64.42% (3.36%; 95% CI, 63.04%-65.81%) at baseline and 62.55% (4.79%; 95% CI, 60.48%-64.62%) at month 12 (P = .16). There was no difference in vascular density parameters between monthly and quarterly injection arms at month 12. Conclusions and Relevance In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy. Because nonperfusion is expected to progress in diabetic retinopathy, this finding may represent a beneficial association between anti-vascular endothelial growth factor therapy and macular vascular density. Trial Registration ClinicalTrials.gov Identifier: NCT02863354.",2020,"In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy.","['32 eyes from 32 patients (mean [SD] age, 48.37', 'Patients With Proliferative Diabetic Retinopathy', '40 eyes of 40 patients with proliferative diabetic retinopathy without diabetic macular edema who were enrolled in the Intravitreal Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy (RECOVERY) clinical trial from August 1, 2016, to June 31, 2017', 'patients with proliferative diabetic retinopathy without diabetic macular edema', '12.30] years; 17 [53.1%] male']","['aflibercept injections', 'OCTA', 'Intravitreal Aflibercept With Optical Coherence Tomography Angiography Vessel Density', 'intravitreal aflibercept']","['macular vascular density', 'mean (SD) total scan vascular density for the superficial vascular complex', 'percentage of vascular density (in total scan and foveal and parafoveal regions', 'mean (SD) vascular density', 'vascular density parameters']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4049512', 'cui_str': 'Retinal nonperfusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",3.0,0.299412,"In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy.","[{'ForeName': 'Ahmed Roshdy', 'Initials': 'AR', 'LastName': 'Alagorie', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Muneeswar Gupta', 'Initials': 'MG', 'LastName': 'Nittala', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Swetha', 'Initials': 'S', 'LastName': 'Velaga', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Rusakevich', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2130'] 2543,32584417,Slicing and dicing small cell lung cancer to improve trial outcomes.,,2020,,[],[],[],[],[],[],,0.0334025,,"[{'ForeName': 'Asrar', 'Initials': 'A', 'LastName': 'AlAhmadi', 'Affiliation': 'Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Dowlati', 'Affiliation': 'Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.'}]",Cancer,['10.1002/cncr.33047'] 2544,32584510,Habits and self-efficacy moderate the effects of intentions and planning on physical activity.,"OBJECTIVES Behavioural intentions as well as action planning can facilitate the adoption and maintenance of physical activity under certain conditions. The present study examined levels of plan-specific self-efficacy and habit strength as possible conditions that may modify this relationship. DESIGN As a secondary analysis of a larger randomized trial to improve physical activity, n = 225 recipients of a planning intervention were followed up at five measurement points over one year. METHODS Two-level models were fit. Within-person levels, that is, fluctuations of intention and action planning around person means, were modelled to predict self-reported moderate-to-vigorous physical activity. Moreover, between-person, that is, average person, levels of self-efficacy and habit strength were specified as putative moderators of this relationship. RESULTS The within-person intention-activity relationship was moderated by between-person levels of habit strength, yielding a compensatory effect: higher-than-usual intention predicted physical activity only when average activity habit levels were low. The within-person planning-activity relationship was moderated by between-person levels of self-efficacy, yielding a synergistic effect: higher-than-usual planning combined with high average self-efficacy resulted in highest physical activity levels. CONCLUSION Higher-than-usual intention may only be required in the presence of low activity habits. Moreover, high self-efficacy seems to be required to translate higher-than-usual action planning into augmented physical activity because self-efficacious individuals may invest more efforts to enact their plans.",2020,"Moreover, high self-efficacy seems to be required to translate higher-than-usual action planning into augmented physical activity because self-efficacious individuals may invest more efforts to enact their plans.",[],[],"['average person, levels of self-efficacy and habit strength']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",225.0,0.018902,"Moreover, high self-efficacy seems to be required to translate higher-than-usual action planning into augmented physical activity because self-efficacious individuals may invest more efforts to enact their plans.","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Di Maio', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Germany.'}, {'ForeName': 'Diana H', 'Initials': 'DH', 'LastName': 'Hohl', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Knoll', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Germany.'}]",British journal of health psychology,['10.1111/bjhp.12452'] 2545,32579785,Clinical phase II and III studies of an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66 ® cell culture platform.,"BACKGROUND We have developed an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66 ® cell culture platform (KD-295). OBJECTIVES In accordance with Japanese guidelines for development of pandemic prototype vaccines, the phase II study was conducted in a double-blind, randomized, parallel-group comparison study and the phase III study was conducted in an open-label, non-randomized, uncontrolled study. METHODS Healthy adult volunteers aged 20 - 64 years enrolled in the phase II and III studies (N = 248 and N = 369) received KD-295 intramuscularly twice with a 21-day interval. After administration, immune response and adverse events were evaluated. In the phase II study, four different vaccine formulations were compared: MA (3.75 μg hemagglutinin [HA] antigen + AS03 adjuvant system), MB (3.75 μg HA + 1/2AS03), HA (7.5 μg HA + AS03), and HB (7.5 μg HA + 1/2AS03). In the phase III study, the MA formulation was further evaluated. RESULTS In the phase II study, all four vaccine formulations were well-tolerated and no SAE related to vaccination were observed. The MA formulation was slightly more immunogenic and less reactogenic among the vaccine formulations. Therefore, the MA formulation was selected for the phase III study, and it was well-tolerated and no serious adverse drug reactions were observed. The vaccine fulfilled the three immunogenicity criteria described in the Japanese guidelines. CONCLUSIONS These data indicate that the MA formulation of KD-295 was well-tolerated and highly immunogenic and it can be considered a useful pandemic and pre-pandemic influenza vaccine.",2020,"In the phase II study, all four vaccine formulations were well-tolerated and no SAE related to vaccination were observed.",['Healthy adult volunteers aged 20\xa0-\xa064\xa0years enrolled in the phase II and III studies (N\xa0=\xa0248 and N\xa0=\xa0369) received'],"['HA (7.5\xa0μg', 'KD-295 intramuscularly twice with a 21-day interval', 'MA (3.75\xa0μg hemagglutinin [HA] antigen\xa0+\xa0AS03 adjuvant system), MB', 'AS03-adjuvanted H5N1 influenza vaccine']","['tolerated and no serious adverse drug reactions', 'immune response and adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C2934792', 'cui_str': 'ASO3B adjuvant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2748361', 'cui_str': 'H5N1 influenza'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0138285,"In the phase II study, all four vaccine formulations were well-tolerated and no SAE related to vaccination were observed.","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Tanishima', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Ibaragi', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Hayashida', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Tanabe', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Naruse', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Kino', 'Affiliation': 'Kino Consulting, Kumamoto, Japan.'}, {'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Kyushu University, Fukuoka, Japan.'}]",Influenza and other respiratory viruses,['10.1111/irv.12755'] 2546,32579798,Biopsychosocial Pain Management and its Effect on Postoperative Opioid Use.,"INTRODUCTION Medical use and overuse of opioids have become an increasing problem over the past several decades. Postoperative pain control is the strongest indication for the use of opioid analgesics. Previous studies have demonstrated benefit from complementary and alternative therapy (CAT) for postoperative pain relief. A prior study conducted by Riswold et al. found that a unit staff training session on CAT improved patient experiences postoperatively following total joint replacement. The study was limited in that it did not examine if there were any changes in opioid usage following this intervention. METHODS This study is a continuation of the Riswold et al. study on CAT training intervention. In July 2017, a four-hour staff training session on alternative comfort measures and pain medication administration took place. Opioid administration data was extracted from the PYXIS software for all patients who had received more than three opioid administrations across their hospital stay in the three months prior to CAT training and the three months post-training. Opioid administrations were converted to total oral morphine equivalents. The pre- and post-intervention groups were compared using independent sample t-tests using SPSS software. RESULTS Statistically significant reduction of total oral morphine equivalents occurred following CAT training intervention (p=.034, CI 2.76, 69.81). Average oral morphine equivalents per day (p=0.023, CI 1.26, 16.57) and per administration (p=0.00048, CI 0.64, 2.25) also were significantly reduced following the CAT training intervention. CONCLUSION This study strengthens the findings of prior studies, showing that CAT can improve patient satisfaction while also reducing overall opioid burden for post-surgical patients.",2020,"Statistically significant reduction of total oral morphine equivalents occurred following CAT training intervention (p=.034, CI 2.76, 69.81).",[],"['CAT', 'alternative therapy (CAT', 'CAT training intervention']","['total oral morphine equivalents', 'overall opioid burden', 'hospital stay']",[],"[{'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0186487,"Statistically significant reduction of total oral morphine equivalents occurred following CAT training intervention (p=.034, CI 2.76, 69.81).","[{'ForeName': 'Isaak', 'Initials': 'I', 'LastName': 'Ailts', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blankespoor', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hannemann', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roach', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Kappel', 'Affiliation': 'Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Beard', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.'}]",South Dakota medicine : the journal of the South Dakota State Medical Association,[] 2547,32579807,Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD.,"BACKGROUND Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β 2 -agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking. METHODS In a 52-week, phase 3, randomized trial to evaluate the efficacy and safety of triple therapy at two dose levels of inhaled glucocorticoid in patients with moderate-to-very-severe COPD and at least one exacerbation in the past year, we assigned patients in a 1:1:1:1 ratio to receive twice-daily inhaled doses of triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide], a LAMA [18 μg of glycopyrrolate], and a LABA [9.6 μg of formoterol]) or one of two dual therapies (18 μg of glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol). The primary end point was the annual rate (the estimated mean number per patient per year) of moderate or severe COPD exacerbations, as analyzed in the modified intention-to-treat population with the use of on-treatment data only. RESULTS The modified intention-to-treat population comprised 8509 patients. The annual rates of moderate or severe exacerbations were 1.08 in the 320-μg-budesonide triple-therapy group (2137 patients), 1.07 in the 160-μg-budesonide triple-therapy group (2121 patients), 1.42 in the glycopyrrolate-formoterol group (2120 patients), and 1.24 in the budesonide-formoterol group (2131 patients). The rate was significantly lower with 320-μg-budesonide triple therapy than with glycopyrrolate-formoterol (24% lower: rate ratio, 0.76; 95% confidence interval [CI], 0.69 to 0.83; P<0.001) or budesonide-formoterol (13% lower: rate ratio, 0.87; 95% CI, 0.79 to 0.95; P = 0.003). Similarly, the rate was significantly lower with 160-μg-budesonide triple therapy than with glycopyrrolate-formoterol (25% lower: rate ratio, 0.75; 95% CI, 0.69 to 0.83; P<0.001) or budesonide-formoterol (14% lower: rate ratio, 0.86; 95% CI, 0.79 to 0.95; P = 0.002). The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group. CONCLUSIONS Triple therapy with twice-daily budesonide (at either the 160-μg or 320-μg dose), glycopyrrolate, and formoterol resulted in a lower rate of moderate or severe COPD exacerbations than glycopyrrolate-formoterol or budesonide-formoterol. (Funded by AstraZeneca, ETHOS ClinicalTrials.gov number, NCT02465567.).",2020,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group. ","['patients with moderate-to-very-severe COPD and at least one exacerbation in the past year', 'Moderate-to-Very-Severe COPD', 'chronic obstructive pulmonary disease (COPD', '8509 patients']","['LAMA', 'glycopyrrolate-formoterol', 'inhaled glucocorticoid', 'triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide', 'glycopyrrolate-formoterol or budesonide-formoterol', 'LABA [9.6 μg of formoterol', 'inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA', 'glycopyrrolate, and formoterol', 'glycopyrrolate', 'budesonide-formoterol', 'glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol']","['moderate or severe COPD exacerbations', 'incidence of confirmed pneumonia', 'annual rates of moderate or severe exacerbations', 'incidence of any adverse event', 'efficacy and safety', 'annual rate', 'rate of moderate or severe COPD exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.540992,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group. ","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'McLaren', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916046'] 2548,32442142,Guided Internet-Based Cognitive Behavioral Therapy in Japanese Patients With Obsessive-Compulsive Disorder: Protocol for a Randomized Controlled Trial.,"BACKGROUND Cognitive behavioral therapy for obsessive-compulsive disorder has been established, but access to this therapy in Japan is limited. Internet-based cognitive behavioral therapy may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. There are few randomized controlled trials examining the effectiveness of internet-based cognitive behavioral therapy in patients with obsessive-compulsive disorder. We designed a randomized controlled trial protocol to assess the effectiveness of guided internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder. OBJECTIVE We aimed to develop a protocol for a randomized controlled trial of internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder. METHODS The randomized controlled trial will compare internet-based cognitive behavioral therapy treatment and usual care groups, each consisting of 15 participants (n=30) diagnosed with obsessive-compulsive disorder. We will evaluate the effectiveness of a 12-week intervention. The primary outcome of symptom severity will be measured using the Yale-Brown Obsessive-Compulsive Scale. Secondary outcomes will be assessed with the Obsessive-Compulsive Inventory, Beck Anxiety Inventory, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Working Alliance Inventory-Short Form, and the Euro Qol - 5 Dimension. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance with the change in total outcomes scores at week 12. All comparisons are planned, and all P values will be two-sided, with values <.05 considered statistically significant. RESULTS The study will be performed from January 2020 to March 2021, and results are expected to be available in mid-2021. CONCLUSIONS The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan. TRIAL REGISTRATION University Hospital Medical Information Network (UMIN) 000039375; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044422. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/18216.",2020,"The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan. ","['Japanese Patients with Obsessive-Compulsive Disorder', 'Japanese patients with obsessive-compulsive disorder', 'patients with obsessive-compulsive disorder in Japan', 'patients with obsessive-compulsive disorder', '15 participants (n=30) diagnosed with obsessive-compulsive disorder']","['internet-based cognitive behavioral therapy', 'guided internet-based cognitive behavioral therapy', 'Cognitive behavioral therapy', 'Internet-based cognitive behavioral therapy', 'Guided Internet-Based Cognitive Behavioral Therapy']","['symptom severity will be measured using the Yale-Brown Obsessive-Compulsive Scale', 'Obsessive-Compulsive Inventory, Beck Anxiety Inventory, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Working Alliance Inventory-Short Form, and the Euro Qol - 5 Dimension', 'obsessive-compulsive symptoms']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472214', 'cui_str': 'Obsessive compulsive inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}]",,0.1134,"The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan. ","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba, Japan.'}, {'ForeName': 'Sayo', 'Initials': 'S', 'LastName': 'Hamatani', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Suzuki', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Seina', 'Initials': 'S', 'LastName': 'Shinno', 'Affiliation': 'Department of Integrated Medical Sciences, Graduate School of Medicine, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ikai', 'Affiliation': 'Department of Primary Health Care, Faculty of Medicine, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Integrated Advanced Medicine, Graduate School of Medicine, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Sutoh', 'Affiliation': 'Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shimizu', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba, Japan.'}]",JMIR research protocols,['10.2196/18216'] 2549,32442148,Patient Perception of Plain-Language Medical Notes Generated Using Artificial Intelligence Software: Pilot Mixed-Methods Study.,"BACKGROUND Clinicians' time with patients has become increasingly limited due to regulatory burden, documentation and billing, administrative responsibilities, and market forces. These factors limit clinicians' time to deliver thorough explanations to patients. OpenNotes began as a research initiative exploring the ability of sharing medical notes with patients to help patients understand their health care. Providing patients access to their medical notes has been shown to have many benefits, including improved patient satisfaction and clinical outcomes. OpenNotes has since evolved into a national movement that helps clinicians share notes with patients. However, a significant barrier to the widespread adoption of OpenNotes has been clinicians' concerns that OpenNotes may cost additional time to correct patient confusion over medical language. Recent advances in artificial intelligence (AI) technology may help resolve this concern by converting medical notes to plain language with minimal time required of clinicians. OBJECTIVE This pilot study assesses patient comprehension and perceived benefits, concerns, and insights regarding an AI-simplified note through comprehension questions and guided interview. METHODS Synthea, a synthetic patient generator, was used to generate a standardized medical-language patient note which was then simplified using AI software. A multiple-choice comprehension assessment questionnaire was drafted with physician input. Study participants were recruited from inpatients at the University of Colorado Hospital. Participants were randomly assigned to be tested for their comprehension of the standardized medical-language version or AI-generated plain-language version of the patient note. Following this, participants reviewed the opposite version of the note and participated in a guided interview. A Student t test was performed to assess for differences in comprehension assessment scores between plain-language and medical-language note groups. Multivariate modeling was performed to assess the impact of demographic variables on comprehension. Interview responses were thematically analyzed. RESULTS Twenty patients agreed to participate. The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant. Age, ethnicity, and health literacy were found to have a significant impact on comprehension scores by multivariate modeling. Thematic analysis of guided interviews highlighted patients' perceived benefits, concerns, and suggestions regarding such notes. Major themes of benefits were that simplified plain-language notes may (1) be more useable than unsimplified medical-language notes, (2) improve the patient-clinician relationship, and (3) empower patients through an enhanced understanding of their health care. CONCLUSIONS AI software may translate medical notes into plain-language notes that are perceived as beneficial by patients. Limitations included sample size, inpatient-only setting, and possible confounding factors. Larger studies are needed to assess comprehension. Insight from patient responses to guided interviews can guide the future study and development of this technology.",2020,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","['Twenty patients agreed to participate', 'Study participants were recruited from inpatients at the University of Colorado Hospital']",['standardized medical language version or AI-generated plain-language version of the patient note'],"['mean number of comprehension assessment questions', 'Interview responses', 'comprehension assessment scores', 'comprehension scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.036171,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bala', 'Affiliation': 'College of Medicine, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Keniston', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Marisha', 'Initials': 'M', 'LastName': 'Burden', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}]",JMIR formative research,['10.2196/16670'] 2550,32442153,Evaluating Engagement in a Digital and Dietetic Intervention Promoting Healthy Weight Gain in Pregnancy: Mixed Methods Study.,"BACKGROUND Early excess and inadequate gestational weight gain (GWG) have been associated with negative outcomes for mother and child. The use of digital media to deliver pregnancy lifestyle interventions is increasing, but there is little data on participant engagement. The Pregnancy Lifestyle Activity and Nutrition (PLAN) intervention pilot study was an electronic health and dietetic-delivered intervention program promoting healthy GWG in early pregnancy. OBJECTIVE This study aims to explore the interactions of participants with the program and to assess its acceptability. METHODS This study uses both quantitative and qualitative methods using data from parent randomized controlled trial (ACTRN12617000725369). Quantitative data from 22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations. A descriptive qualitative analysis employed semistructured interviews with 9 participants to elicit views on the acceptability of the intervention and its components. RESULTS The electronic delivery of information and recording of weight from 8 to 20 weeks of gestation were universally accepted. Component (face-to-face dietitian, weight tracker, website information delivery, and SMS goal prompting) acceptability and engagement differed between individuals. A total of 4 key themes emerged from the qualitative analysis: supporting lifestyle change, component acceptability and value, delivery platforms, and engagement barriers. CONCLUSIONS The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women. Individuals responded differently to various components, emphasizing the importance of including women in the development of lifestyle interventions and allowing participants to choose and tailor programs. Larger randomized controlled trials using these insights in a broader section of the community are needed to inform the iterative development of practical, time-efficient, and cost-effective ways of supporting optimal GWG with the potential to optimize outcomes for pregnant women and their child.",2020,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"['pregnant women and their child', 'pregnant women', ""Women's Engagement With Pregnancy Lifestyle Activity and Nutrition"", '22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations']","['Electronic Health and Dietetic Intervention', 'electronic health and dietetic-delivered intervention program promoting healthy GWG']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",[],22.0,0.0728469,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"[{'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Willcox', 'Affiliation': 'La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chai', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': 'The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, Australia.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Neppe', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, Australia.'}, {'ForeName': 'Rae-Chi', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}]",Journal of medical Internet research,['10.2196/17845'] 2551,32442673,Salivary oxytocin after oxytocin administration: Examining the moderating role of childhood trauma.,"Although oxytocin administration influences behavior, its effects on peripheral oxytocin concentrations are mixed and derived from studies on healthy subjects. Additionally, trauma attenuates the behavioral effects of oxytocin, but it is unknown whether it also influences its effect on peripheral circulation. This study examined whether salivary oxytocin increased after oxytocin administration and whether trauma attenuated this effect. We conducted a randomized, double-blind, placebo-controlled, within-subjects study in 100 male adolescents living in residential youth care facilities. Participants self-administered intranasally 24 IU of oxytocin and placebo (one week later) and provided a saliva sample before and 15 min after administration. Salivary oxytocin increased significantly after oxytocin administration, but this effect might be inflated by exogenous oxytocin reaching the throat. Trauma did not moderate this effect. Our findings suggest that trauma did not attenuate the effect of oxytocin administration on salivary oxytocin, but more robust methodologies are recommended to draw more solid conclusions.",2020,Trauma did not moderate this effect.,"['100 male adolescents living in residential youth care facilities', 'healthy subjects']","['oxytocin', 'salivary oxytocin', 'Salivary oxytocin', 'oxytocin and placebo', 'placebo']","['Salivary oxytocin', 'peripheral oxytocin concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",100.0,0.442201,Trauma did not moderate this effect.,"[{'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Fragkaki', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands. Electronic address: i.fragkaki@pwo.ru.nl.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107903'] 2552,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045'] 2553,32443036,Effectivity of Pancreatic Enzyme Replacement Therapy in Malnourished Children.,"OBJECTIVE Malnutrition is commonly seen in children with exocrine pancreatic insufficiency (EPI). Pancreatic enzyme replacement therapy (PERT) is the mainstay treatment of acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis). The effectiveness of PERT in children with malnutrition without any chronic disease, however, remains unclear. The aim of this study was to investigate the effectiveness of PERT on weight gain and EPI in children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification. MATERIALS AND METHODS The study included a total of 40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification. The patients were randomly divided into 2 groups: PERT group (n = 20) received 2000 U lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only. In both groups, anthropometric measurements and the assessment of fecal elastase-1 (FE-1) levels were performed both at first admission and at the end of the 8-week treatment period. RESULTS On the basis of WHO classification, 10 (25%) children were classified as severely malnourished and 30 (75%) children as moderately malnourished. EPI was detected in all the patients, among whom 24 (60%) patients had severe EPI. At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels. Similarly, no significant difference was found between pre- and posttreatment measurements of PERT and control groups (P > 0.05) and between pre- and posttreatment measurements of patients with moderate and severe malnutrition (P > 0.05). CONCLUSIONS Malnutrition remains a serious public health problem, and thus, the development of novel treatment methods is highly essential. PERT is one of the most commonly considered alternatives, although there is little documentation of PERT in the literature. In the present study, although PERT resulted in higher weight gain, it established no significant difference between the 2 groups.",2020,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","['children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification', 'children with exocrine pancreatic insufficiency (EPI', '40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification', 'acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis', 'Malnourished Children', 'children with malnutrition without any chronic disease']","['2000\u200aU lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only', 'Pancreatic Enzyme Replacement Therapy', 'Pancreatic enzyme replacement therapy (PERT', 'PERT']","['body weight, height, and body mass index (BMI', 'fecal elastase-1 (FE-1) levels', 'weight gain', 'severe malnutrition', 'severe EPI', 'weight gain and EPI', 'waist circumference (WC) and FE-1 levels', 'EPI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4523842', 'cui_str': 'Pancreatic enzyme replacement therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1272315', 'cui_str': 'Fecal elastase 1 level'}]",40.0,0.0311251,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Güven', 'Affiliation': 'Department of Pediatric Gastroenterology, Karadeniz Technical University Faculty of Medicine, Trabzon.'}, {'ForeName': 'Mevsim', 'Initials': 'M', 'LastName': 'Demir Mis', 'Affiliation': 'Department of Pediatrics, Van Yuzuncu Yil University Faculty of Medicine, Van.'}, {'ForeName': 'Kamuran', 'Initials': 'K', 'LastName': 'Karaman', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}, {'ForeName': 'Akkiz', 'Initials': 'A', 'LastName': 'Şahin Yaşar', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002689'] 2554,32444250,Variation of faecal calprotectin level within the first three months after bowel resection is predictive of endoscopic postoperative recurrence in Crohn's disease.,"BACKGROUND Early prediction of postoperative recurrence (POR) remains a major concern in Crohn's disease (CD). AIMS To assess serial faecal calprotectin (Fcal) monitoring within the first three months to predict CD endoscopic POR. METHODS In a multicenter randomized controlled trial, CD patients received azathioprine 2.5 mg/kg/day with oral curcumin (3 g/day) or placebo. Fcal was measured at baseline, one month (M1) and M3. Endoscopic POR at M6 was defined as Rutgeerts' index ≥ i2b (central reading). RESULTS Among the 48 patients included, there was no significant difference of median Fcal levels at baseline (p = 0.15), M1 (p = 0.44) and M3 (p = 0.28) between patients with or without endoscopic POR at M6. Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021). The median variation between Fcal level at baseline and M3 (ΔFcal M3-M0) was significantly higher in patients with endoscopic POR compared to those without POR (p = 0.01). ΔFcal M3-M0 >+10% demonstrated the best performances to predict endoscopic POR at M6 (AUC=0.73, sensitivity=64.7%[41.1-82.7], specificity=87.5%[68.0-96.3], negative predictive value=77.8%[57.5-91.4] and positive predictive value=78.6%[49.2-95.3]). CONCLUSION Fcal variation within the first three months after ileocolonic resection is a promising predictor of early endoscopic POR in CD patients.",2020,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[""Crohn's disease (CD"", ""Crohn's disease"", 'CD patients']","['azathioprine 2.5\u202fmg/kg/day with oral curcumin', 'ileocolonic resection', 'placebo']","['faecal calprotectin level', 'median variation between Fcal level at baseline and M3 (ΔFcal M3-M0', 'Fcal kinetics', 'serial faecal calprotectin (Fcal) monitoring', 'Endoscopic POR', 'Fcal', 'median Fcal levels']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",48.0,0.135478,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[{'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Boube', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': 'Gastroenterology Department, University Hospital, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Nancey', 'Affiliation': 'Hospices Civils de Lyon, Lyon-Sud hospital, Gastroenterology, Pierre Benite, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hebuterne', 'Affiliation': 'Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University of Nice Sophia-Antipolis, Nice, France.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': 'Gastroenterology Department, University Hospital, Amiens, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pariente', 'Affiliation': 'Gastroenterology Department, University Hospital, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Gastroenterology Department, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, CHU Nancy Brabois, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Minet-Quinard', 'Affiliation': 'CHU Clermont-Ferrand, Laboratoire de Biochimie, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU Clermont-Ferrand, DRCI, Unité de Biostatistiques, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Bommelaer', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France. Electronic address: a_buisson@hotmail.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.020'] 2555,32444573,"Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT).","PURPOSE To investigate the effectiveness of outpatient robot-assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy. METHODS Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure - 88 (GMFM E) was the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5 - week follow - up. RESULTS The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were - 0.7 (-2.8 to 3.5) after RAGT and 0 (-2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable. CONCLUSIONS RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children's personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.",2020,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable. ","['children with cerebral palsy (PeLoGAIT', '16 children with a mean age of 11.3 years (6.0-15.3 years', 'ambulatory children with spastic cerebral palsy', 'Children']","['outpatient robot-assisted gait training (RAGT', 'robot-assisted gait training', 'RAGT']","['Dimension D (GMFM D), and timed walking tests', 'walking abilities', 'GMFM E median (IQR) change scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",16.0,0.0332735,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable. ","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Ammann-Reiffer', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Caroline H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Functioning and Rehabilitation, CAPHRI, Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Meyer-Heim', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Hubertus J A', 'Initials': 'HJA', 'LastName': 'van Hedel', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-190614'] 2556,32444629,Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial.,"Minimally invasive surgery for inguinal hernia repair is advantageous in terms of return to usual activities and lower rates of chronic pain; however, it requires general anesthesia. This study sought to analyze the benefits of ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block) as a single anesthetic technique for endoscopic totally extraperitoneal (TEP) inguinal hernia repair with regard to postoperative pain, length of hospital stay, and hospital cost. A total of 46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair. In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia. Consequently, the former group showed a briefer median hospital stay (6 versus 24 hours, respectively). The anesthesia and hospital costs were also lower for the QL block group, with median reductions of 64.15% and 25%, respectively. QL block is a safe and effective option for patients undergoing TEP inguinal hernia repair, given the observed reduction in early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs.",2020,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"['46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received', 'Tep) Inguinal Hernia Repair', 'patients undergoing TEP inguinal hernia repair']","['ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block', 'general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair', 'Laparoscopic Totally Extraperitoneal', 'Minimally invasive surgery', 'QL block', 'endoscopic totally extraperitoneal (TEP) inguinal hernia repair']","['median pain score', 'Quadratus Lumborum Block', 'anesthesia and hospital costs', 'briefer median hospital stay', 'postoperative pain, length of hospital stay, and hospital cost', 'early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",46.0,0.130019,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"[{'ForeName': 'Murillo de Lima', 'Initials': 'ML', 'LastName': 'Favaro', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil. mlfavaro@prof.unisa.br.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Gabor', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Diogo Barros Florenzano', 'Initials': 'DBF', 'LastName': 'Souza', 'Affiliation': 'Professor of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Anderson Alcoforado', 'Initials': 'AA', 'LastName': 'Araújo', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Ana Luiza Castro', 'Initials': 'ALC', 'LastName': 'Milani', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Augusto Fontenelle', 'Initials': 'MAF', 'LastName': 'Ribeiro Junior', 'Affiliation': 'Full Professor of General Surgery at the University Santo Amaro, São Paulo, Brazil.'}]",Scientific reports,['10.1038/s41598-020-65604-x'] 2557,32445902,"The impact of height-adjustable desks and classroom prompts on classroom sitting time, social, and motivational factors among adolescents.","PURPOSE This quasi-experimental study examined the impact of height-adjustable desks in combination with prompts to break up prolonged sitting time during class time and identified social and motivational factors associated with breaking up sitting time among adolescents. Teachers' perceptions of strategies were also examined. METHODS Over 17 weeks, 1 classroom in a government secondary school in Melbourne, Australia, was equipped with 27 height-adjustable desks and prompts (posters and desk stickers) to break up classroom sitting time. Teachers received professional development in the use of the desks and prompts. One group of adolescents (n = 55) had 2-5 lessons/week using the height-adjustable desks in an intervention classroom, and a comparison group matched by year level and subject (n = 50) was taught in traditional ""seated"" classrooms. Adolescents wore an activPAL monitor at baseline (T0), 4 weeks (T1), and 17 weeks (T2) and completed a survey at T0 and T2. Six teachers participated in interviews at T2. Effect sizes were calculated (d). RESULTS Linear mixed models found that, compared to the traditional ""seated"" classrooms, the adolescents in the intervention classroom had significantly lower sitting time (T1: -9.7 min/lesson, d = -0.96; T2: -6.7 min/lesson, d = -0.70) and time spent in sitting bouts >15 min (T2: -11.2 min/lesson, d = -0.62), and had significantly higher standing time (T1: 7.3 min/lesson, d = 0.84; T2: 5.8 min/lesson, d = 0.91), number of breaks from sitting (T1: 1.3 breaks/lesson, d = 0.49; T2: 1.8 breaks/lesson, d = 0.67), and stepping time (T1: 2.5 min/lesson, d = 0.66). Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50). CONCLUSION This intervention shows promise for targeting sitting behaviors in the classroom and indicates that incorporating social and motivational strategies may further enhance outcomes.",2020,"Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50). ","['Six teachers participated in interviews at T2', 'adolescents']",[],"['standing time', 'habit strength', 'self-efficacy for breaking up sitting time', 'sitting time', 'classroom sitting time, social, and motivational factors', 'stepping time', 'time spent in sitting bouts >15 min', 'number of breaks from sitting']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445131', 'cui_str': 'Number of breaks'}]",6.0,0.0132516,"Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50). ","[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Sudholz', 'Affiliation': 'Pomegranate Community Mental Health, St John of God Social Outreach, Ballarat, VIC 3350, Australia.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Contardo Ayala', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia. Electronic address: a.contardoayala@deakin.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Timperio', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia; Physical Activity Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Conroy', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA 16802, USA; Department of Preventive Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Abbott', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Holland', 'Affiliation': 'The Australian Council for Health and Physical Education and Recreation, Abbotsford, VIC 3067, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Arundell', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.05.002'] 2558,32445969,How do oncoming traffic and cyclist lane position influence cyclist overtaking by drivers?,"Overtaking cyclists is challenging for drivers because it requires a well-timed, safe interaction between the driver, the cyclist, and the oncoming traffic. Previous research has investigated this manoeuvre in different experimental environments, including naturalistic driving, naturalistic cycling, and simulator studies. These studies highlight the significance of oncoming traffic-but did not extensively examine the influence of the cyclist's position within the lane. In this study, we performed a test-track experiment to investigate how oncoming traffic and position of the cyclist within the lane influence overtaking. Participants overtook a robot cyclist, which was controlled to ride in two different lateral positions within the lane. At the same time, an oncoming robot vehicle was controlled to meet the participant's vehicle with either 6 or 9 s time-to-collision. The order of scenarios was randomised over participants. We analysed safety metrics for the four different overtaking phases, reflecting drivers' safety margins to rear-end, head-on, and side-swipe collisions, in order to investigate the two binary factors: 1) time gap between ego vehicle and oncoming vehicle, and 2) cyclist lateral position. Finally, the effects of these two factors on the safety metrics and the overtaking strategy (either flying or accelerative depending on whether the overtaking happened before or after the oncoming vehicle had passed) were analysed. The results showed that, both when the cyclist rode closer to the centre of the lane and when the time gap to the oncoming vehicle was shorter, safety margins for all potential collisions decreased. Under these conditions, drivers-particularly female drivers-preferred accelerative over flying manoeuvres. Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.",2020,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,[],[],[],[],[],[],,0.0264438,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rasch', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: alexander.rasch@chalmers.se.'}, {'ForeName': 'Christian-Nils', 'Initials': 'CN', 'LastName': 'Boda', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: christian-nils.boda@chalmers.se.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Thalya', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden; Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: prateek.thalya@veoneer.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Aderum', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: tobias.aderum@veoneer.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Knauss', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: alessia.knauss@veoneer.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Dozza', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: marco.dozza@chalmers.se.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105569'] 2559,32446979,"Xinyue Capsule in patients with stable coronary artery disease after percutaneous coronary intervention: a multicenter, randomized, placebo-controlled trial.","BACKGROUND Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown. METHODS In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36). RESULTS A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008). CONCLUSIONS In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization).",2020,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008). ","['patients with stable CAD who underwent', 'A total of 1054 participants were included in the analyses', 'patients with stable coronary artery disease after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'Xinyue capsule (100\u2009mg panax quinquefolius saponins, three times a day) or placebo', 'Xinyue Capsule', 'placebo']","['SF-36 subscale scores', 'Secondary end-point events', 'Quality of life', 'composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting', 'stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality', 'incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1054.0,0.559087,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008). ","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Zhuye', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of the Henan University of Chinese Medicine, Henan 450046, China.'}, {'ForeName': 'Shuzheng', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 10029, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'The First Affiliated Hospital of Jilin University of Traditional Chinese Medicine, Changchun 130021, China.'}, {'ForeName': 'Tianchang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Naval General Hospital, Beijing 100048, China.'}, {'ForeName': 'Dazhuo', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China. Electronic address: shidazhuo@cacms.cn.'}, {'ForeName': 'For The Xy', 'Initials': 'FTX', 'LastName': 'Working Group', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}]",Pharmacological research,['10.1016/j.phrs.2020.104883'] 2560,32453304,Effects of Different Plyometric Training Frequencies on Measures of Athletic Performance in Prepuberal Male Soccer Players.,"Bouguezzi, R, Chaabene, H, Negra, Y, Ramirez-Campillo, R, Jlalia, Z, Mkaouer, B, and Hachana, Y. Effects of different plyometric training frequencies on measures of athletic performance in prepuberal male soccer players. J Strength Cond Res 34(6): 1609-1617, 2020-This study aimed to compare the effects of 1 vs. 2 sessions of equal-weekly volume plyometric training (PT) across 8 weeks on measures of athletic performance (i.e., sprint time, change of direction [CoD], jumping ability, and muscle strength) in prepuberal male soccer players. Thirty participants were randomly assigned either to 1 session PT group (1SPT [n = 15]) or 2 sessions PT group (2SPT [n = 15]). Plyometric training was integrated into their regular soccer training routine. Pretraining and posttraining tests for the assessment of sprint time (e.g., 5, 10, 20, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], countermovement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance were conducted. Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94 [large], p = 0.02), SLJ (F(1,56) = 16.63, ES = 1.09 [large], p < 0.001), CMJ (F(1,56) = 15.43, ES = 1.04 [large], p < 0.001), SJ (F(1,56) = 20.27, ES = 1.20 [large], p < 0.001), RSI (F(1,56) = 26.26, ES = 1.36 [large], p < 0.001), and kicking distance (F(1,56) = 47.19, ES = 1.83 [large], p < 0.001). There were no training group × time interactions in all the measured outcomes. In conclusion, when an equated moderate volume of jumps is performed, higher PT frequency across 8 weeks has no extra effects on prepuberal male soccer players' measures of athletic performance. The present findings may help optimizing PT interventions dedicated to prepuberal male soccer players.",2020,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94","['Prepuberal Male Soccer Players', 'J Strength Cond Res 34(6', 'prepuberal male soccer players', 'Thirty participants']","['Plyometric Training Frequencies', 'equal-weekly volume plyometric training (PT', 'Plyometric training']","['athletic performance (i.e., sprint time, change of direction [CoD], jumping ability, and muscle strength', 'sprint time (e.g., 5, 10, 20, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], countermovement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance', 'Athletic Performance', 'time interactions', 'time for 5-m sprint-time performance', 'athletic performance', 'Bouguezzi, R, Chaabene, H, Negra, Y, Ramirez-Campillo, R, Jlalia, Z, Mkaouer, B, and Hachana']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",30.0,0.0338811,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, University of Los Lagos, Osorno, Chile.'}, {'ForeName': 'Zied', 'Initials': 'Z', 'LastName': 'Jlalia', 'Affiliation': 'Faculty of Medicine of Tunis, University of Tunis El Manar, Orthopedic Pediatric Department, Kassab Institute of Orthopedic Surgery, Ksar Said, Tunisia.'}, {'ForeName': 'Bessem', 'Initials': 'B', 'LastName': 'Mkaouer', 'Affiliation': 'Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Younés', 'Initials': 'Y', 'LastName': 'Hachana', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002486'] 2561,32453369,Effect of Doxycycline on Aneurysm Growth Among Patients With Small Infrarenal Abdominal Aortic Aneurysms: A Randomized Clinical Trial.,"Importance Abdominal aortic aneurysms affect more than 3% of US older adults. Objective To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter. Design, Setting, and Participants Parallel, 2-group, randomized clinical trial that was conducted at 22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms. The final date of follow-up was July 31, 2018. Interventions Patients were randomized to receive twice daily for 2 years doxycycline 100 mg orally (as capsules) (n = 133) or placebo (n = 128). Main Outcomes and Measures The primary outcome was change in abdominal aortic aneurysm maximum transverse diameter measured from CT images at baseline and follow-up at 2 years. Patients were assigned ranks based on the maximum transverse diameter (measured or imputed) of the aorta and also if they underwent aneurysm repair or died. The ranks were converted to scores having a normal distribution to facilitate the primary analysis (""normal scores""). Results Of 261 patients randomized, no follow-up CT scans were obtained on 7 (3%), leaving a final analysis set of 129 patients assigned to doxycycline and 125 to placebo (mean [SD] age, 71.0 years [7.4 years], 35 women [14%]). The outcome normal scores used in the primary analysis were based on maximum transverse diameter (measured or imputed) in 113 patients (88%) in the doxycycline group and 112 patients (90%) in the placebo group; aneurysm repair in 13 (10%) and 9 (7%), and death in 3 (2%) and 4 (3%), respectively. The primary outcome, normal scores reflecting change in aortic diameter, did not differ significantly between the 2 groups, mean change in normal scores, 0.0262 vs -0.0258 (1-sided P = .71). Mean (SD) baseline maximum transverse diameter was 4.3 cm (0.4 cm) for doxycycline and 4.3 cm (0.4 cm) for placebo. At the 2-year follow-up, the change in measured maximum transverse diameter was 0.36 cm (95% CI, 0.31 to 0.40 cm) for 96 patients in the doxycycline group vs 0.36 cm (95% CI, 0.30 to 0.41 cm) for 101 patients in the placebo group (difference, 0.0; 95% CI, -0.07 to 0.07 cm; 2-sided P = .93). No patients were withdrawn from the study because of adverse effects. Joint pain occurred in 84 of 129 patients (65%) with doxycycline and 79 of 125 (63%) with placebo. Conclusions and Relevance Among patients with small infrarenal abdominal aortic aneurysms, doxycycline compared with placebo did not significantly reduce aneurysm growth at 2 years. These findings do not support the use of doxycycline for reducing the growth of small abdominal aortic aneurysms. Trial Registration ClinicalTrials.gov Identifier: NCT01756833.",2020,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter. ","['22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms', 'Patients With Small Infrarenal Abdominal Aortic Aneurysms', 'patients with small infrarenal abdominal aortic aneurysms', '261 patients randomized']","['Doxycycline', 'doxycycline 100 mg orally (as capsules', 'doxycycline', 'placebo']","['Joint pain', 'maximum transverse diameter', 'growth of abdominal aortic aneurysm', 'death', 'mean change in normal scores', 'normal scores reflecting change in aortic diameter', 'change in abdominal aortic aneurysm maximum transverse diameter measured from CT images', 'Mean (SD) baseline maximum transverse diameter', 'aneurysm repair', 'aneurysm growth']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0579133', 'cui_str': 'Aortic diameter'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]",261.0,0.567673,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter. ","[{'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Baxter', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Matsumura', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Curci', 'Affiliation': 'Department of Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, Washington.'}, {'ForeName': 'LuAnn', 'Initials': 'L', 'LastName': 'Larson', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Blackwelder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lam', 'Affiliation': 'Genentech, Oakland, California.'}, {'ForeName': 'Marniker', 'Initials': 'M', 'LastName': 'Wijesinha', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.5230'] 2562,32451288,Efficacy and adherence of sublingual immunotherapy in patients aged 60 to 75 years old with house dust mite-induced allergic rhinitis.,"PURPOSE This study aimed to evaluate the efficacy and adherence of sublingual immunotherapy (SLIT) for house dust mite (HDM)-induced allergic rhinitis (AR) patients over 60 years old. MATERIALS AND METHODS Eighty-six AR patients aged 60-75 years old were randomly divided in the control and treatment group as 1:1 ratio. The control group was treated with standard pharmacotherapy while the treatment group was treated with SLIT plus pharmacotherapy on demand. Patients adherence, combined symptom and medication score (CSMS), visual analog scale (VAS), and presence of adverse events were evaluated in the baseline and after 6-months, 12-months and 24-months treatment. RESULTS Twenty-five (58.1%) subjects in the treatment group and 20 (46.5%) subjects in the control group completed the study (P > 0.05). The major reasons for premature cessation were out of touch and relieved symptoms. At the same time, CSMS and VAS of the patients over 60 years old in both groups significantly decreased from baseline to any post-baseline time point (all P < 0.05). The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05). CONCLUSION 41.9% of the patients dropped out within 2 years of SLIT treatment and the major reasons for premature cessation were out of touch and relieved symptoms. This study suggested that SLIT plus pharmacotherapy provided a greater clinical benefit than pharmacotherapy alone at two years.",2020,"The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05). ","['house dust mite (HDM)-induced allergic rhinitis (AR) patients over 60\xa0years old', 'Eighty-six AR patients aged 60-75\xa0years old', 'patients aged 60 to 75\xa0years old with house dust mite-induced allergic rhinitis']","['sublingual immunotherapy', 'sublingual immunotherapy (SLIT', 'standard pharmacotherapy', 'SLIT plus pharmacotherapy']","['Patients adherence, combined symptom and medication score (CSMS), visual analog scale (VAS), and presence of adverse events', 'CSMS and VAS', 'Efficacy and adherence']","[{'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",86.0,0.0113207,"The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05). ","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Biyu', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Shaopeng', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Qinhua', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Ruiyu', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China. Electronic address: liruiyu_phd@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102538'] 2563,32580188,"A Phase 3, Multicenter, Randomized, Two-Arm, Open-Label Study of Intermittent Oral Dosing of Roxadustat for the Treatment of Anemia in Japanese Erythropoiesis-Stimulating Agent-Naïve Chronic Kidney Disease Patients Not on Dialysis.","INTRODUCTION Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved for the treatment of anemia in Japan for patients with dialysis-dependent (DD) chronic kidney disease (CKD). OBJECTIVE Multicenter, randomized, open-label, noncomparative, phase 3 study to evaluate roxadustat for anemia of non-dialysis-dependent (NDD) CKD in Japan. METHODS Erythropoiesis stimulating agent (ESA)-naïve NDD-CKD patients were randomized to roxadustat (initial dose, 50 or 70 mg 3 times weekly), titrated to maintain hemoglobin (Hb) within 10.0-12.0 g/dL, for ≤24 weeks. Patients with either transferrin saturation of ≥5% or serum ferritin of ≥30 ng/mL during the screening period were eligible. Endpoints included response rate (proportion of patients achieving Hb ≥10.0 or ≥10.5 g/dL and Hb increase ≥1.0 g/dL from baseline) at end of treatment; average Hb (weeks 18-24); change of average Hb from baseline to weeks 18-24; maintenance rate (proportion of patients achieving Hb 10.0-12.0 g/dL at weeks 18-24); rate of rise (RoR) of Hb from weeks 0-4, discontinuation, or dose adjustment. Adverse events were monitored throughout the study. RESULTS Of 135 patients who provided informed consent, 100 were randomized and 99 received roxadustat (50 mg, n = 49; 70 mg, n = 50). The mean (SD) dose of roxadustat per intake at week 22 was 36.3 (22.7) mg in the roxadustat 50 mg group and 36.8 (16.0) mg in the roxadustat 70 mg group. Prior medications included oral iron therapy (20.2%) and intravenous iron therapy (1.0%). Overall response rate (95% CI) was 97.0% (91.4, 99.4; Hb ≥10.0 g/dL) and 94.9% (88.6, 98.3; Hb ≥10.5 g/dL). Mean (SD) Hb (weeks 18-24) was 11.17 (0.62) g/dL. Mean (SD) change of Hb from baseline (weeks 18-24) was 1.34 (0.86) g/dL. Maintenance rate (95% CI) was 88.8% (80.3, 94.5) among patients with ≥1 Hb measurement during weeks 18-24. Mean (SD) RoR of Hb was 0.291 (0.197) g/dL/week (50 mg) and 0.373 (0.235) g/dL/week (70 mg). Nasopharyngitis and hypertension were the most common adverse events. CONCLUSION Roxadustat increased and maintained Hb in ESA-naïve, partially iron-depleted NDD-CKD patients with anemia.",2020,"Overall response rate (95% CI) was 97.0% (91.4, 99.4;","['anemia of non-dialysis-dependent (NDD) CKD in Japan', 'Patients with either transferrin saturation of ≥5% or serum ferritin of ≥30 ng/mL during the screening period were eligible', '135 patients who provided informed consent, 100 were randomized and 99 received', 'anemia in Japan for patients with dialysis-dependent (DD) chronic kidney disease (CKD', 'Erythropoiesis stimulating agent (ESA)-naïve NDD-CKD patients', 'Japanese Erythropoiesis-Stimulating Agent-Naïve Chronic Kidney Disease Patients Not on Dialysis']","['oral iron therapy', 'roxadustat', 'intravenous iron therapy']","['Nasopharyngitis and hypertension', 'Mean (SD) RoR of Hb', 'Adverse events', 'response rate', 'Overall response rate', 'mean (SD) dose of roxadustat per intake']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",135.0,0.0562269,"Overall response rate (95% CI) was 97.0% (91.4, 99.4;","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan, akizawa@med.showa-u.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'Data Science, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Japan-Asia Clinical Development 2, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Therapeutic Area Medical Specialties, Astellas Pharma Europe B.V., Leiden, The Netherlands.'}]",Nephron,['10.1159/000508100'] 2564,32580207,Metabolic activity in subcallosal cingulate predicts response to deep brain stimulation for depression.,"Subcallosal cingulate (SCC) deep brain stimulation (DBS) is a promising therapy for treatment-resistant depression (TRD), but response rates in open-label studies were not replicated in a large multicenter trial. Identifying biomarkers of response could improve patient selection and outcomes. We examined SCC metabolic activity as both a predictor and marker of SCC DBS treatment response. Brain glucose metabolism (CMRGlu) was measured with [18F] FDG-PET at baseline and 6 months post DBS in 20 TRD patients in a double-blind randomized controlled trial where two stimulation types (long pulse width (LPW) n = 9 and short pulse width (SPW) n = 11) were used. Responders (n = 10) were defined by a ≥48% reduction in Hamilton Depression Rating Scale scores after 6 months. The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%). First, differences in SCC CMRGlu in responders and non-responders were compared at baseline. Then machine learning analysis was performed with a leave-one-out cross-validation using a Gaussian naive Bayes classifier to test whether baseline CMRGlu in SCC could categorize responders. Finally, we compared 6-month change in metabolic activity with change in depression severity. All analyses were controlled for age. Baseline SCC CMRGlu was significantly higher in responders than non-responders. The machine learning analysis predicted response with 80% accuracy. Furthermore, reduction in SCC CMRGlu 6 months post DBS correlated with symptom improvement (r(17) = 0.509; p = 0.031). This is the first evidence of an image-based treatment selection biomarker that predicts SCC DBS response. Future studies could utilize SCC metabolic activity for prospective patient selection.",2020,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,['20 TRD patients'],['Subcallosal cingulate (SCC) deep brain stimulation (DBS'],"['Brain glucose metabolism (CMRGlu', 'Baseline SCC CMRGlu', 'SCC metabolic activity', 'response rates', 'metabolic activity', 'Hamilton Depression Rating Scale scores']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0983597,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,"[{'ForeName': 'Elliot C', 'Initials': 'EC', 'LastName': 'Brown', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Clark', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nils D', 'Initials': 'ND', 'LastName': 'Forkert', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Molnar', 'Affiliation': 'Department of Radiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Zelma H T', 'Initials': 'ZHT', 'LastName': 'Kiss', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada. rramasub@ucalgary.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0745-5'] 2565,31806881,"OPRM1, OPRK1, and COMT genetic polymorphisms associated with opioid effects on experimental pain: a randomized, double-blind, placebo-controlled study.","Genetic polymorphisms have been shown to affect opioid requirement for pain relief. However, true genetic effect is often difficult to assess due to underlying pain conditions and placebo effects. The goal of this study was to understand how common polymorphisms affect opioid effects while controlling for these factors. A randomized, double-blind, placebo-controlled study was implemented to assess how opioid effects are modulated by COMT (rs6269, rs4633, rs4848, rs4680), OPRM1 (A118G), and OPRK1 (rs1051660, rs702764, rs16918875). One hundred and eight healthy subjects underwent experimental pain testing before and after morphine, butorphanol, and placebo (saline). Association analysis was performed between polymorphisms/haplotypes and opioid response, while correcting for race, gender, placebo effects, and multiple comparisons. Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol. The AA genotype of rs4680 or A_T_C_A/ A_T_C_A (rs6269_rs4633_ rs4818_rs4680) diplotype of COMT, combined with the AG genotype of OPRM1 A118G, showed significantly increased pressure pain threshold from butorphanol. Opioid effects on pressure, ischemic, heat pain, and side effects were nominally associated with several SNPs and haplotypes. Effects were often present in one opioid but not the other. This indicates that these polymorphisms affect pain relief from opioids, and that their effects are opioid and pain modality specific.",2020,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,['One hundred and eight healthy subjects'],"['butorphanol', 'morphine, butorphanol, and placebo (saline', 'placebo']","['Pressure pain', 'pressure, ischemic, heat pain, and side effects', 'pressure pain', 'experimental pain']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",108.0,0.58088,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,"[{'ForeName': 'Kwo Wei David', 'Initials': 'KWD', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University, Redwood City, CA, USA. kwoweiho@stanford.edu.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Wallace', 'Affiliation': 'Department of Molecular Genetics & Microbiology, and UF Genetics Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville, FL, USA.'}]",The pharmacogenomics journal,['10.1038/s41397-019-0131-z'] 2566,32468646,"Nilotinib Effects on Safety, Tolerability, and Biomarkers in Alzheimer's Disease.","OBJECTIVE Preclinical evidence with nilotinib, a US Food and Drug Administration (FDA)-approved drug for leukemia, indicates improvement in Alzheimer's disease phenotypes. We investigated whether nilotinib is safe, and detectable in cerebrospinal fluid, and alters biomarkers and clinical decline in Alzheimer's disease. METHODS This single-center, phase 2, randomized, double-blind, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers in participants with mild to moderate dementia due to Alzheimer's disease. The diagnosis was supported by cerebrospinal fluid or amyloid positron emission tomography biomarkers. Nilotinib 150 mg versus matching placebo was taken orally once daily for 26 weeks followed by nilotinib 300 mg versus placebo for another 26 weeks. RESULTS Of the 37 individuals enrolled, 27 were women and the mean (SD) age was 70.7 (6.48) years. Nilotinib was well-tolerated, although more adverse events, particularly mood swings, were noted with the 300 mg dose. In the nilotinib group, central nervous system (CNS) amyloid burden was significantly reduced in the frontal lobe compared to the placebo group. Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo. Hippocampal volume loss was attenuated (-27%) at 12 months and phospho-tau-181 was reduced at 6 months and 12 months in the nilotinib group. INTERPRETATION Nilotinib is safe and achieves pharmacologically relevant cerebrospinal fluid concentrations. Biomarkers of disease were altered in response to nilotinib treatment. These data support a larger, longer, multicenter study to determine the safety and efficacy of nilotinib in Alzheimer's disease. ANN NEUROL 2020 ANN NEUROL 2020;88:183-194.",2020,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[""participants with mild to moderate dementia due to Alzheimer's disease"", ' 27 were women and the mean (SD) age was 70.7 (6.48) years', '37 individuals enrolled', ""Alzheimer's disease""]","['Nilotinib 150 mg versus matching placebo', 'nilotinib 300 mg versus placebo', 'placebo']","['safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers', ""Safety, Tolerability, and Biomarkers in Alzheimer's Disease"", 'Hippocampal volume loss', 'central nervous system (CNS) amyloid burden', 'Cerebrospinal fluid Aβ40', 'safety and efficacy']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C2920193', 'cui_str': 'nilotinib 150 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",27.0,0.589561,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[{'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Turner', 'Affiliation': 'Memory Disorders Program, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Michaeline L', 'Initials': 'ML', 'LastName': 'Hebron', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Lawler', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Mundel', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Yusuf', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'J Nathan', 'Initials': 'JN', 'LastName': 'Starr', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Anjum', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Torres-Yaghi', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Wangke', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Mulki', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Ferrante', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Nuclear Medicine, Washington, DC, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Radiology, MedStar Georgetown Hospital, Washington, DC, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Neuroscience, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Jaeil', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Moussa', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}]",Annals of neurology,['10.1002/ana.25775'] 2567,32468649,"Pharmacokinetics, Pharmacodynamics, and Safety of the Dual Orexin Receptor Antagonist Lemborexant: Findings From Single-Dose and Multiple-Ascending-Dose Phase 1 Studies in Healthy Adults.","Lemborexant, a dual orexin receptor antagonist, is approved for the treatment of insomnia and is under investigation for treating other sleep disorders. Here we summarize pharmacokinetic, pharmacodynamic, and safety data from 3 randomized, double-blind, placebo-controlled phase 1 studies: single ascending doses in healthy adults (Study 001; 1-200 mg; N = 64), multiple ascending doses in healthy and elderly adults (Study 002; 2.5-75 mg; N = 55), and multiple doses in healthy white and Japanese adults (Study 003; 2.5-25 mg; N = 32). Lemborexant exposure increased with increasing dose. The time to maximum concentration ranged from approximately 1 to 3 hours for the 5- and 10-mg doses. The mean effective half-life was 17 hours for lemborexant 5 mg and 19 hours for lemborexant 10 mg. The plasma concentration at 9 hours postdose was 27% of the maximum concentration following multiple dosing with lemborexant 10 mg. There were no clinically relevant effects on next-morning residual sleepiness (Karolinska Sleepiness Scale, Digital Symbol Substitution Test, Psychomotor Vigilance Test) for doses through 10 mg/day, indicating no effect of residual plasma concentrations on next-day residual effects. Lemborexant was well tolerated across the doses tested. There were no clinically relevant effects of age, sex, or race on lemborexant pharmacokinetics, pharmacodynamics, or safety. These results suggest that lemborexant at doses through 25 mg provides an overall pharmacokinetic, pharmacodynamic, and safety profile suitable for obtaining the target pharmacologic effect supporting treatment of insomnia while minimizing residual effects during wake time.",2020,"There were no clinically relevant effects of age, sex, or race on lemborexant pharmacokinetics, pharmacodynamics, or safety.","['Healthy Adults', 'healthy adults (Study 001; 1-200\xa0mg; N\xa0=\xa064), multiple ascending doses in healthy and elderly adults (Study 002; 2.5-75\xa0mg; N\xa0=\xa055), and multiple doses in healthy white and Japanese adults (Study 003; 2.5-25\xa0mg; N\xa0=\xa032']","['Lemborexant', 'lemborexant', 'Dual Orexin Receptor Antagonist Lemborexant', 'placebo']","['next-morning residual sleepiness (Karolinska Sleepiness Scale, Digital Symbol Substitution Test, Psychomotor Vigilance Test', 'Pharmacokinetics, Pharmacodynamics, and Safety', 'residual plasma concentrations', 'plasma concentration', 'lemborexant pharmacokinetics, pharmacodynamics, or safety', 'mean effective half-life', 'Lemborexant exposure']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0580197,"There were no clinically relevant effects of age, sex, or race on lemborexant pharmacokinetics, pharmacodynamics, or safety.","[{'ForeName': 'Ishani', 'Initials': 'I', 'LastName': 'Landry', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'Eisai Co, Ltd, Koishikawa, Tokyo, Japan.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Ferry', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Jagadeesh', 'Initials': 'J', 'LastName': 'Aluri', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Bojan', 'Initials': 'B', 'LastName': 'Lalovic', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.817'] 2568,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts. MAIN OUTCOME MEASURES 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS 15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033). INTERPRETATION As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial. FUNDING The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006'] 2569,32471973,The neuropeptide substance P regulates aldosterone secretion in human adrenals.,"Aldosterone, produced by the adrenals and under the control of plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure. Here we report that the neuropeptide substance P (SP) released by intraadrenal nerve fibres, stimulates aldosterone secretion via binding to neurokinin type 1 receptors (NK1R) expressed by aldosterone-producing adrenocortical cells. The action of SP is mediated by the extracellular signal-regulated kinase pathway and involves upregulation of steroidogenic enzymes. We also conducted a prospective proof-of-concept, double blind, placebo-controlled clinical trial aimed to investigate the impact of the NK1R antagonist aprepitant on aldosterone secretion in healthy male volunteers (EudraCT: 2008-003367-40, ClinicalTrial.gov: NCT00977223). Participants received during two 7-day treatment periods aprepitant (125 mg on the 1 st day and 80 mg during the following days) or placebo in a random order at a 2-week interval. The primary endpoint was plasma aldosterone levels during posture test. Secondary endpoints included basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH during the three different stimulatory tests. The safety of the treatment was assessed on the basis of serum transaminase measurements on days 4 and 7. All pre-specified endpoints were achieved. Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture. These results indicate that the autonomic nervous system exerts a direct stimulatory tone on mineralocorticoid synthesis through SP, and thus plays a role in the maintenance of hydromineral homeostasis. This regulatory mechanism may be involved in aldosterone excess syndromes.",2020,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"['healthy male volunteers (EudraCT', 'human adrenals']","['NK1R antagonist aprepitant', 'Aldosterone', 'neuropeptide substance P (SP', 'placebo']","['plasma aldosterone levels', 'aldosterone secretion', 'aldosterone production', 'plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure', 'basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}]","[{'cui': 'C0038581', 'cui_str': 'Neurokinin alpha'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]",,0.0620632,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Wils', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Duparc', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Cailleux', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Antoine-Guy', 'Initials': 'AG', 'LastName': 'Lopez', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Guiheneuf', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutelet', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hadrien-Gaël', 'Initials': 'HG', 'LastName': 'Boyer', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubessy', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Saloua', 'Initials': 'S', 'LastName': 'Cherifi', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cauliez', 'Affiliation': 'Rouen University Hospital, Department of Biochemistry, 76000, Rouen, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Gobet', 'Affiliation': 'Rouen University Hospital, Department of Pathology, 76000, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Defortescu', 'Affiliation': 'Rouen University Hospital, Department of Urology, 76000, Rouen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Ménard', 'Affiliation': 'Rouen University Hospital, Department of Biostatistics, 76000, Rouen, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Louiset', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lefebvre', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France. herve.lefebvre@chu-rouen.fr.'}]",Nature communications,['10.1038/s41467-020-16470-8'] 2570,32444220,A Phase II Randomized Clinical Trial of the Safety and Efficacy of Intravenous Umbilical Cord Blood Infusion for Treatment of Children with Autism Spectrum Disorder.,"OBJECTIVE To evaluate whether umbilical cord blood (CB) infusion is safe and associated with improved social and communication abilities in children with autism spectrum disorder (ASD). STUDY DESIGN This prospective, randomized, placebo-controlled, double-blind study included 180 children with ASD, aged 2-7 years, who received a single intravenous autologous (n = 56) or allogeneic (n = 63) CB infusion vs placebo (n = 61) and were evaluated at 6 months postinfusion. RESULTS CB infusion was safe and well tolerated. Analysis of the entire sample showed no evidence that CB was associated with improvements in the primary outcome, social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test). There was also no overall evidence of differential effects by type of CB infused. In a subanalysis of children without intellectual disability (ID), allogeneic, but not autologous, CB was associated with improvement in a larger percentage of children on the clinician-rated Clinical Global Impression-Improvement scale, but the OR for improvement was not significant. Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. CONCLUSIONS Overall, a single infusion of CB was not associated with improved socialization skills or reduced autism symptoms. More research is warranted to determine whether CB infusion is an effective treatment for some children with ASD.",2020,"Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. ","['Children with Autism Spectrum Disorder', 'children with ASD', 'children with autism spectrum disorder (ASD', '180 children with ASD, aged 2-7\xa0years, who received a single intravenous autologous (n\xa0=\xa056) or allogeneic (n\xa0=\xa063']","['CB', 'CB infusion vs placebo', 'Intravenous Umbilical Cord Blood Infusion', 'CB infusion', 'umbilical cord blood (CB) infusion', 'placebo']","['socialization skills or reduced autism symptoms', 'social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test', 'communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power', 'safe and well tolerated']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C0077962', 'cui_str': 'VAB-III protocol'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0042927', 'cui_str': 'Vocabulary Tests'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",180.0,0.486169,"Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. ","[{'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC; Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC. Electronic address: geraldine.dawson@duke.edu.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Deaver', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Franz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heilbron', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Herold', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horrigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kosinski', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Major', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Murias', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Prasad', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Sabatos-DeVito', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Sanfilippo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Simmons', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Song', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC; Duke Brain Imaging and Analysis Center, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Saritha', 'Initials': 'S', 'LastName': 'Vermeer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Waters-Pick', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Troy', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Kurtzberg', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.011'] 2571,32444221,Efficacy of a Primary Care-Based Intervention to Promote Parent-Teen Communication and Well-Being: A Randomized Controlled Trial.,"OBJECTIVE To evaluate the impact of a primary care-based, parent-directed intervention on changes in parent-teen communication, parental beliefs about adolescents, parent and adolescent well-being, adolescent distress, and adolescent positive affect from baseline to 2-month follow-up. STUDY DESIGN In this randomized controlled trial, 120 adolescents (13-15 years of age) scheduled for well visits and their parents were randomized to the strength intervention or control group. The intervention included a booklet highlighting 3 key messages about adolescence, instructions to have a discussion with their teen about each other's strengths, and clinician endorsement. Outcomes were assessed before the well visit and 2 months later. RESULTS Adolescents were 61% female and 65% black. Parents were primarily female (97%); 72% had a 4-year degree or higher. The intervention had a positive impact on adolescent-reported open communication among adolescents with baseline low open communication scores (B = 3.55; P = .005; 95% CI, 1.07-6.03). Adolescents in the intervention group reported a decrease in distress (-1.54 vs 3.78; P = .05; partial eta squared [η 2 ] = 0.038) and increase in positive affect (1.30 vs -3.64; P = .05; η 2  = 0.04) compared with control group adolescents. The intervention did not affect parent-reported communication, parental beliefs, or adolescent well-being. Control parents demonstrated a marginal increase in well-being, whereas intervention parents did not (0.82 vs -0.18; P = .07; η 2  = 0.029). CONCLUSIONS This study highlights the potential impact of primary care-based, universal, low-intensity interventions targeting parents of adolescents on parent-teen communication and important adolescent health outcomes. TRIAL REGISTRATION Clinicaltrials.gov: NCT03496155.",2020,Adolescents in the intervention group reported a decrease in distress (-1.54 vs 3.78; P = .05; partial eta squared [η 2 ] = 0.038) and increase in positive affect (1.30 vs -3.64; P = .05; η 2  = 0.04) compared with control group adolescents.,"['120 adolescents (13-15\xa0years of age) scheduled for well visits and their parents', 'Parents were primarily female (97%); 72% had a 4-year degree or higher', 'Adolescents were 61% female and 65% black']","[""booklet highlighting 3 key messages about adolescence, instructions to have a discussion with their teen about each other's strengths, and clinician endorsement"", 'primary care-based, parent-directed intervention', 'Primary Care-Based Intervention to Promote Parent-Teen Communication and Well-Being', 'strength intervention or control group']","['distress', 'communication, parental beliefs, or adolescent well-being']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4042782', 'cui_str': 'Adolescent Well Being'}]",120.0,0.116073,Adolescents in the intervention group reported a decrease in distress (-1.54 vs 3.78; P = .05; partial eta squared [η 2 ] = 0.038) and increase in positive affect (1.30 vs -3.64; P = .05; η 2  = 0.04) compared with control group adolescents.,"[{'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA. Electronic address: millerv@email.chop.edu.""}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Silva', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Friedrich', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Reyneris', 'Initials': 'R', 'LastName': 'Robles', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Ford', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.050'] 2572,32444980,Randomized prospective trial of fractionated stereotactic radiosurgery with chemotherapy versus chemotherapy alone for bevacizumab-resistant high-grade glioma.,"PURPOSE Outcomes for patients with recurrent high-grade glioma (HGG) progressing on bevacizumab (BEV) are dismal. Fractionated stereotactic radiosurgery (FSRS) has been shown to be feasible and safe when delivered in this setting, but prospective evidence is lacking. This single-institution randomized trial compared FSRS plus BEV-based chemotherapy versus BEV-based chemotherapy alone for BEV-resistant recurrent malignant glioma. MATERIALS AND METHODS HGG patients on BEV with tumor progression after 2 previous treatments were randomized to 1) FSRS plus BEV-based chemotherapy or 2) BEV-based chemotherapy with irinotecan, etoposide, temozolomide, or carboplatin. FSRS was delivered as 32 Gy (8 Gy × 4 fractions within 2 weeks) to the gross target volume and 24 Gy (6 Gy × 4 fractions) to the clinical target volume (fluid-attenuated inversion recovery abnormality). The primary endpoints were local control (LC) at 2 months and progression-free survival (PFS). RESULTS Of the 35 patients enrolled, 29 had glioblastoma (WHO IV) and 6 had anaplastic glioma (WHO III). The median number of prior recurrences was 3. Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002). The overall median survival was 6.6 months (7.2 months with FSRS vs 4.8 months with chemotherapy alone, P = .11). CONCLUSIONS FSRS combined with BEV-based chemotherapy in recurrent HGG patients progressing on BEV is feasible and improves LC and PFS when compared to treatment with BEV-based chemotherapy alone.",2020,"Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002).","['6 had anaplastic glioma (WHO III', '35 patients enrolled, 29 had glioblastoma (WHO IV) and', 'HGG patients on BEV with tumor progression after 2 previous treatments', 'resistant high-grade glioma', 'patients with recurrent high-grade glioma (HGG) progressing on']","['Fractionated stereotactic radiosurgery (FSRS', 'FSRS plus BEV-based chemotherapy or 2) BEV-based chemotherapy with irinotecan, etoposide, temozolomide, or carboplatin', 'bevacizumab (BEV', 'fractionated stereotactic radiosurgery with chemotherapy versus chemotherapy', 'FSRS combined with BEV-based chemotherapy', 'FSRS plus BEV-based chemotherapy versus BEV-based chemotherapy alone', 'FSRS', 'bevacizumab']","['median number of prior recurrences', 'local control (LC) at 2\xa0months and progression-free survival (PFS', 'PFS', 'overall median survival']","[{'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0085203', 'cui_str': 'Radiosurgery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",35.0,0.0793639,"Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bergman', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Modh', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Lonni', 'Initials': 'L', 'LastName': 'Schultz', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Snyder', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ryu', 'Affiliation': 'Department of Radiation Oncology, Stony Brook University Hospital, 101 Nicolls Road, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'M Salim', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA. twalber1@hfhs.org.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03526-4'] 2573,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8'] 2574,32580074,Impact of electrical cardioversion on quality of life for patients with symptomatic persistent atrial fibrillation: Is there a treatment expectation effect?,"It is assumed that electrical cardioversion (ECV) improves the quality of life (QoL) of patients with atrial fibrillation (AF) by restoring sinus rhythm (SR). OBJECTIVE We examined the effect of ECV and rhythm status on QoL of patients with symptomatic persistent AF in a randomized controlled trial. METHOD The elective cardioversion for prevention of symptomatic atrial fibrillation trial examined the efficacy of dronedarone around the time of ECV in maintaining SR. Quality of life was measured with the University of Toronto Atrial Fibrillation Severity Scale. The primary outcome was the change in AF symptom severity (∆AFSS) score over 6 months (0-35 points, with higher scores reflecting worse QoL and a minimal clinically important difference defined as ∆AFSS ≥3 points). Multivariable linear regression was performed to identify factors associated with changes in QoL. RESULTS We included 148 patients with complete AFSS scores at baseline and 6 months. Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups). After adjustment of baseline covariates, maintenance of SR was associated with QoL improvement (ΔAFSS: -3.8 points, 95% CI: -6.0 to -1.6 points, P < .01). CONCLUSIONS Maintenance of SR was associated with clinically relevant improvement in patients' QoL at 6 months. Patients with AF recurrence had a small but still relevant improvement in their QoL, potentially due to factors other than sinus rhythm.",2020,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","['Patients with AF recurrence', 'patients with symptomatic persistent atrial fibrillation', '148 patients with complete AFSS scores at baseline and 6 months', 'patients with symptomatic persistent AF', 'patients with atrial fibrillation (AF) by restoring sinus rhythm (SR']","['electrical cardioversion', 'dronedarone', 'ECV', 'electrical cardioversion (ECV']","['quality of life', 'University of Toronto Atrial Fibrillation Severity Scale', 'quality of life (QoL', 'change in AF symptom severity (∆AFSS) score', 'Quality of life', 'AF relapse', 'unsuccessful ECV', 'QoL improved irrespective of rhythm status (ΔAFSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",148.0,0.042951,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","[{'ForeName': 'Andrew C T', 'Initials': 'ACT', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Center, University Health Network, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: andrew.ha@uhn.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': 'Arrhythmia Service, University Hospital, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, Ontario, Canada; St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",American heart journal,['10.1016/j.ahj.2020.05.004'] 2575,32580161,Effect of Weekly Training Frequency With the Nordic Hamstring Exercise on Muscle-Strain Risk Factors in Football Players: A Randomized Trial.,"PURPOSE To examine the differences between performing Nordic hamstring exercises once or twice a week on hamstring eccentric strength and other muscle-strain risk factors in high-level football players. METHODS In this randomized trial, 32 football players (18-23 y old) completed an 8-week Nordic hamstring exercise training program in 1 of 2 experimental groups: group 1 (once a week; n = 15) and group 2 (twice a week; n = 17). Knee-flexor/extensor peak torques and biceps femoris long-head muscle architecture were assessed through isokinetic dynamometry and ultrasonography, respectively, before and after the training programs. Analysis of covariance, effect sizes (ESs), and t tests for percentage change were used to assess the effect of the 2 interventions on the outcome measures. RESULTS Group 2 demonstrated higher hamstring concentric peak torque than group 1 posttraining (155-164 vs 149-158 N·m; P = .043; ES = 0.27), although there was also a statistical trend for higher hamstring eccentric peak torque (212-234 vs 198-221 N·m; P = .098; ES = 0.37), hamstring-to-quadriceps conventional ratio (0.56-0.59 vs 0.54-0.57; P = .089; ES = 0.31), and hamstring-to-quadriceps functional ratio (0.76-0.84 vs 0.71-0.79; P = .076; ES = 0.50). No between-groups differences were found for muscle thickness (P = .864; ES = 0.12), pennation angle (P = .289; ES = 0.18), fascicle length (P = .406; ES = 0.03), and quadriceps concentric peak torque (P = .340; ES = 0.02). CONCLUSION Only the Nordic hamstring exercise training program performed twice a week strengthened the hamstrings of high-level football players, while similar changes in muscle architecture occurred with both once- and twice-weekly sessions.",2020,"RESULTS Group 2 demonstrated higher hamstring concentric peak torque than group 1 posttraining (155-164 vs 149-158 N·m; P = .043; ES = 0.27), although there was also a statistical trend for higher hamstring eccentric peak torque (212-234 vs 198-221 N·m; P = .098; ES = 0.37), hamstring-to-quadriceps conventional ratio (0.56-0.59 vs 0.54-0.57; P = .089; ES = 0.31), and hamstring-to-quadriceps functional ratio (0.76-0.84 vs 0.71-0.79; P = .076; ES = 0.50).","['32 football players (18-23 y old', 'Football Players', 'high-level football players']","['Weekly Training Frequency With the Nordic Hamstring Exercise', 'Nordic hamstring exercise training program', 'Nordic hamstring exercises']","['hamstring-to-quadriceps conventional ratio', 'quadriceps concentric peak torque', 'hamstring concentric peak torque', 'muscle thickness', 'hamstring-to-quadriceps functional ratio', 'hamstring eccentric peak torque', 'fascicle length']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.0225161,"RESULTS Group 2 demonstrated higher hamstring concentric peak torque than group 1 posttraining (155-164 vs 149-158 N·m; P = .043; ES = 0.27), although there was also a statistical trend for higher hamstring eccentric peak torque (212-234 vs 198-221 N·m; P = .098; ES = 0.37), hamstring-to-quadriceps conventional ratio (0.56-0.59 vs 0.54-0.57; P = .089; ES = 0.31), and hamstring-to-quadriceps functional ratio (0.76-0.84 vs 0.71-0.79; P = .076; ES = 0.50).","[{'ForeName': 'Thales M', 'Initials': 'TM', 'LastName': 'Medeiros', 'Affiliation': ''}, {'ForeName': 'João B', 'Initials': 'JB', 'LastName': 'Ribeiro-Alvares', 'Affiliation': ''}, {'ForeName': 'Carolina G', 'Initials': 'CG', 'LastName': 'Fritsch', 'Affiliation': ''}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Severo-Silveira', 'Affiliation': ''}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Pappas', 'Affiliation': ''}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2018-0780'] 2576,32449083,Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Heart Failure Events in Patients with Type 2 Diabetes Mellitus: A Cost Per Outcome Analysis.,"BACKGROUND AND OBJECTIVE Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have significant efficacy in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) mortality in patients with type 2 diabetes mellitus (T2DM). However, there are differences in HF outcomes between the SGLT2i. Therefore, we compared the cost needed to achieve these outcomes between empagliflozin, canagliflozin, and dapagliflozin. METHODS We calculated the cost needed to treat (CNT) in order to prevent one event of hHF or CV mortality, by multiplying the annualized number needed to treat (NNT) to prevent one event, by the annual cost of each therapy. Efficacy estimates were extracted from published randomized controlled trial (RCT) data. A sensitivity analysis was performed to mitigate differences between the RCT populations. Drug costs were extracted from the 2020 US National Average Drug Acquisition Cost listing. RESULTS We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin. The sensitivity analysis confirmed the cost advantage of empagliflozin. CONCLUSIONS Our findings suggest that empagliflozin prescribed for preventing CV death or hHF in T2DM patients seems to be cost saving compared to treatment with canagliflozin, and dapagliflozin.",2020,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Sodium-glucose cotransporter 2 inhibitors (SGLT2i', 'empagliflozin', 'empagliflozin, canagliflozin, and dapagliflozin', 'Sodium-Glucose Cotransporter 2 Inhibitors']","['HF outcomes', 'cardiovascular (CV) mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.173062,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","[{'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Arbel', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel. ronen.arbel@gmail.com.'}, {'ForeName': 'Enis', 'Initials': 'E', 'LastName': 'Aboalhasan', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hammerman', 'Affiliation': 'Department of Pharmaceutical Technology Assessment, Clalit Health Services Headquarters, Tel-Aviv, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Azuri', 'Affiliation': 'Diabetes Clinic, Central District, Maccabi Healthcare Services, Tel Aviv, Israel.'}]",Clinical drug investigation,['10.1007/s40261-020-00929-z'] 2577,32580164,REducing SEDENTary Behavior Among Mild to Moderate Cognitively Impaired Assisted Living Residents: A Pilot Randomized Controlled Trial (RESEDENT Study).,"Older adults in assisted living spend most of their day in sedentary behaviors, which may be detrimental to cognitive function. The primary purpose of this pilot study was to assess the feasibility of using a prompting device to reduce sitting time with light walking among older adults with mild to moderate cognitive impairment residing in an assisted living setting. A secondary purpose was to examine the effectiveness of the intervention on the residents' cognitive function, physical function, and quality of life. The participants (n = 25, mean age = 86.7 [5.3] years) were assigned in clusters into a two-arm 10-week single-site pilot randomized controlled trial. The intervention group was prompted with a watch to interrupt sedentary behaviors and partake in 10 min of light physical activity (i.e., walking) three times a day after a meal. The assessments included hip-worn accelerometers (Actical) and diaries, the Alzheimer's disease assessment scale-cognitive, Timed Up and Go, and the short-form 36 health survey. Adherence was high, as there were no dropouts, and over 70% of the participants completed over 80% of the prescribed physical activity bouts. Significant effects favoring the intervention were shown for all outcomes.",2020,Significant effects favoring the intervention were shown for all outcomes.,"['participants (n = 25, mean age = 86.7 [5.3] years', 'Mild to Moderate Cognitively Impaired Assisted Living Residents', 'older adults with mild to moderate cognitive impairment residing in an assisted living setting', 'Older adults']",['light walking'],"[""hip-worn accelerometers (Actical) and diaries, the Alzheimer's disease assessment scale-cognitive, Timed Up and Go, and the short-form 36 health survey"", ""residents' cognitive function, physical function, and quality of life"", 'Adherence']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0952938,Significant effects favoring the intervention were shown for all outcomes.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dillon', 'Affiliation': ''}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0440'] 2578,32454161,Acute methylphenidate administration reduces cocaine-cue attentional bias.,"Mechanistic research on behavioral processes underlying substance use disorder might help identify novel targets for interventions development. Drug-related attentional bias and response inhibition deficits have received a great deal of consideration in substance use research, broadly, and cocaine use research, specifically. Studies investigating pharmacological mechanisms that may ameliorate, or further impair, these behaviors relevant to cocaine use are relatively lacking. This study evaluated the impact of acute administration of methylphenidate, a dopamine-favoring reuptake inhibitor, on both gaze-related cocaine-cue-attentional bias and cocaine-cue related disruptions in response inhibition among individuals with cocaine use disorder. Participants (N = 12; 33% female) completed a within-subject, outpatient, acute dosing study. Two sessions were completed in which methylphenidate (60 mg) or placebo were administered followed by completion of an attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks. Subjective and physiological effects were also recorded. Significant cocaine cue attentional bias and response inhibition failures were observed during placebo administration. Acute methylphenidate administration reduced cocaine-cue attentional bias as measured by cocaine-cue gaze fixations (d z  = 1.04; Bayes Factor = 12.37). No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04). Methylphenidate produced prototypical subjective and physiological effects. Although the small sample should be considered, these findings indicate acute manipulation of dopaminergic activity reduced cue-related attentional allocation related to cocaine use disorder. Future research evaluating alternative dopaminergic agents and applications within a clinical setting are needed to determine the clinical significance of targeting this neurobehavioral mechanism.",2020,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"['individuals with cocaine use disorder', 'Participants (N\u202f=\u202f12; 33% female) completed a within-subject, outpatient, acute dosing study']","['cocaine-cue gaze fixations ', 'attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks', 'methylphenidate', 'Methylphenidate', 'Acute methylphenidate', 'placebo']","['prototypical subjective and physiological effects', 'response inhibition', 'cocaine-cue attentional bias', 'Subjective and physiological effects', 'Significant cocaine cue attentional bias and response inhibition failures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",2.0,0.0536529,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"[{'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Alcorn', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA. Electronic address: Craig.Rush@uky.edu.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109974'] 2579,32458035,Simultaneous single-stage versus two-staged bilateral total knee arthroplasty: a prospective comparative study.,"PURPOSE The study aims to prospectively compare peri-operative morbidity and mortality of simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA) performed within 12 months of the first surgery. We hypothesized that SS BLTKA is as safe as TS BLTKA. METHODS Patients with a minimum follow-up of 12 months were included in this study. Oxford knee score and quality of life index SF12 was compared between the 2 groups at six weeks and six month follow-up. RESULTS SS BLTKA included 250 patients and TS BLTKA included 210 patients. The minimum time interval between two operations was three weeks (mean 1.6 months, range 3 weeks-12 months). There was no significant difference between the 2 groups in peri-operative mortality, surgical site infection, major peri-operative complications. There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up. There was no difference in the range of knee flexion between the 2 groups at six months. Post-operative haemoglobin drop was significantly more in SS BLTKA patients and consequently, blood transfusion requirement was significantly higher in SS BLTKA. There was a significantly higher length of hospital stay and duration of surgery in TS BLTKA group. CONCLUSION There does not appear to be a difference in complication rates between the 2 groups. SS BLTKA seems to be a logical choice if both knees have severe osteoarthritis. Patients with severe cardiopulmonary compromise were excluded, and a unilateral procedure may be preferred in them.",2020,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"['Patients with severe cardiopulmonary compromise', 'Patients with a minimum follow-up of 12\xa0months', '250 patients and TS BLTKA included 210 patients']","['Simultaneous single-stage versus two-staged bilateral total knee arthroplasty', 'simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA']","['blood transfusion requirement', 'length of hospital stay and duration of surgery', 'complication rates', 'peri-operative mortality, surgical site infection, major peri-operative complications', 'minimum time interval', 'Oxford knee score and quality of life index SF12', 'range of knee flexion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0576095', 'cui_str': 'Range of knee flexion'}]",250.0,0.0426341,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"[{'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Bathinda, Punjab, 151001, India. goyal.tarun@gmail.com.'}, {'ForeName': 'Md Quamar', 'Initials': 'MQ', 'LastName': 'Azam', 'Affiliation': 'Department of Trauma Surgery, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Syed', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Rishikesh, India.'}]",International orthopaedics,['10.1007/s00264-020-04642-6'] 2580,32463279,The effects of inhaled flavors on intravenous nicotine.,"Menthol is the only available flavor in combusted tobacco cigarettes; however, e-cigarettes are available in thousands of flavors. Research on flavors and rewarding properties of nicotine is limited. The present study sought to examine the acute rewarding effects of flavors inhaled from an e-cigarette, in combination with intravenous (IV) nicotine among cigarette smokers. In the present study, 24 menthol-preferring young adult (aged 18 to 30) cigarette smokers were tested under 3 different e-cigarette flavor conditions (menthol, green apple, or menthol + green apple) in a within-subject cross-over design. During each test session, each participant received 3 IV infusions (saline, 0.25 mg/70 kg nicotine, 0.5 mg/70 kg nicotine) administered 1 hr apart. The main outcome measures assessed cardiovascular, subjective, and cognitive domains. Compared with green apple or green apple + menthol, menthol produced higher ratings of ""cooling"" ( p s < 0.01). Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05). As expected, IV-nicotine dose-dependently increased the ratings of subjective liking/disliking and peak heart rate, improved cognitive performance, and reduced smoking urges (all p s < 0.05). These subjective, cognitive, and physiological effects of nicotine were not affected by any flavor condition. The present findings did not support an interaction between IV-nicotine dose and inhaled flavor for acute effects of nicotine. Green apple flavor, alone or in combination with menthol, could result in higher craving or insufficiently alleviate craving, relative to menthol flavor alone. Additional research is warranted to examine extended exposure to inhaled flavors on the rewarding and addictive effects of nicotine. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05).,"['cigarette smokers', '24 menthol-preferring young adult (aged 18 to 30) cigarette smokers']","['IV infusions (saline, 0.25 mg/70 kg nicotine, 0.5 mg/70 kg nicotine', 'Green apple flavor, alone or in combination with menthol', 'cigarette flavor conditions (menthol, green apple, or menthol + green apple', 'Menthol', 'inhaled flavors', 'nicotine', 'flavors inhaled from an e-cigarette, in combination with intravenous (IV) nicotine', 'green apple or green apple + menthol, menthol']","['cardiovascular, subjective, and cognitive domains', 'ratings of subjective liking/disliking and peak heart rate, improved cognitive performance, and reduced smoking urges', 'Craving', 'ratings of ""cooling']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0475653', 'cui_str': 'Apple flavor'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",,0.0245257,Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05).,"[{'ForeName': 'R Ross', 'Initials': 'RR', 'LastName': 'MacLean', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'DeVito', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'MacKenzie R', 'Initials': 'MR', 'LastName': 'Peltier', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Suprit', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'VA Connecticut Healthcare System.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000394'] 2581,32580841,Influence of Preemptive Analgesia with Oxycodone Hydrochloride on Stress Hormone Level of Geriatric Patients undergoing Gastrointestinal Surgery.,"OBJECTIVE To determine the influence of preemptive analgesia with oxycodone hydrochloride on stress hormone level of geriatric patients undergoing gastrointestinal surgery, and evaluate the analgesic effect. STUDY DESIGN Rrandomised controlled trial. PLACE AND DURATION OF STUDY Department of Anaesthesiology, Baoding First Central Hospital, from January to December 2017. METHODOLOGY Geriatric patients who were to undergo gastrointestinal surgery were classified into observation group and control group of 30 patients each. For the observation group, intravenous injection of 0.1mg/kg oxycodone hydrochloride injection was conducted 10 mins before anesthesia induction. For the control group, intravenous injection of 10 ml normal saline was conducted. Eight ml of venous blood was drawn 10 mins before injection (T0), after operation (T1), 2 hours after operation (T2), 6 hours after operation (T3), and 24 hours after operation (T4). Serum concentration of cortisol, epinephrine, noradrenaline was determined after the completion of surgery (T1), 2-hour after surgery (T2), 6-hour after surgery (t3) and 24-hour after sutrgery (T4). for both groups. Visual analogue scale (VAS) score was used for assessment of pain when the surgery was completed; and after the surgery, was compared for both groups. RESULTS Serum concentrations of epinephrine and noradrenaline in observation group were significantly reduced at T1 and T2 (p <0.05), and serum concentrations of cortisol and glucose were significantly reduced at T1, T2 and T3 (p <0.05). At 2 and 6-hours after operation, the VAS score was significantly lower than that of the control group (p<0.05). CONCLUSION Giving oxycodone hydrochloride to geriatric patients receiving gastrointestinal surgery can reduce stress hormone release in the postoperative period, and can facilitate postoperative recovery. Key Words: Sold, Gastrointestinal surgery, Oxycodone hydrochloride, Preemptive analgesia, Stress response.",2020,"Serum concentrations of epinephrine and noradrenaline in observation group were significantly reduced at T1 and T2 (p <0.05), and serum concentrations of cortisol and glucose were significantly reduced at T1, T2 and T3 (p <0.05).","['Geriatric patients who were to undergo gastrointestinal surgery were classified into observation group and control group of 30 patients each', 'geriatric patients undergoing gastrointestinal surgery', 'geriatric patients receiving gastrointestinal surgery', 'Geriatric Patients undergoing Gastrointestinal Surgery']","['oxycodone hydrochloride', 'intravenous injection of 10 ml normal saline', 'Oxycodone Hydrochloride', 'oxycodone hydrochloride injection', 'Gastrointestinal surgery, Oxycodone hydrochloride']","['Serum concentration of cortisol, epinephrine, noradrenaline', 'VAS score', 'Visual analogue scale (VAS) score', 'stress hormone level', 'Serum concentrations of epinephrine and noradrenaline', 'Stress Hormone Level', 'serum concentrations of cortisol and glucose', 'stress hormone release']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",,0.0153231,"Serum concentrations of epinephrine and noradrenaline in observation group were significantly reduced at T1 and T2 (p <0.05), and serum concentrations of cortisol and glucose were significantly reduced at T1, T2 and T3 (p <0.05).","[{'ForeName': 'Jinli', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Baoding First Central Hospital, Baoding, Hebei, P. R. China.'}, {'ForeName': 'Yixuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Fourth Clinical Institute, Class 2016, Xinxiang Medical University, Xinxiang, Henan, P. R. China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Scientific Research, Affiliated Hospital of Hebei University, Baoding, Hebei, P. R. China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Scientific Research, Affiliated Hospital of Hebei University, Baoding, Hebei, P. R. China.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.05.476'] 2582,32580883,"Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial.","BACKGROUND We aimed to identify a five-fraction schedule of adjuvant radiotherapy (radiation therapy) delivered in 1 week that is non-inferior in terms of local cancer control and is as safe as an international standard 15-fraction regimen after primary surgery for early breast cancer. Here, we present 5-year results of the FAST-Forward trial. METHODS FAST-Forward is a multicentre, phase 3, randomised, non-inferiority trial done at 97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK. Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible. We randomly allocated patients to either 40 Gy in 15 fractions (over 3 weeks), 27 Gy in five fractions (over 1 week), or 26 Gy in five fractions (over 1 week) to the whole breast or chest wall. Allocation was not masked because of the nature of the intervention. The primary endpoint was ipsilateral breast tumour relapse; assuming a 2% 5-year incidence for 40 Gy, non-inferiority was predefined as ≤1·6% excess for five-fraction schedules (critical hazard ratio [HR] of 1·81). Normal tissue effects were assessed by clinicians, patients, and from photographs. This trial is registered at isrctn.com, ISRCTN19906132. FINDINGS Between Nov 24, 2011, and June 19, 2014, we recruited and obtained consent from 4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule. At a median follow-up of 71·5 months (IQR 71·3 to 71·7), the primary endpoint event occurred in 79 patients (31 in the 40 Gy group, 27 in the 27 Gy group, and 21 in the 26 Gy group); HRs versus 40 Gy in 15 fractions were 0·86 (95% CI 0·51 to 1·44) for 27 Gy in five fractions and 0·67 (0·38 to 1·16) for 26 Gy in five fractions. 5-year incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions). At 5 years, any moderate or marked clinician-assessed normal tissue effects in the breast or chest wall was reported for 98 of 986 (9·9%) 40 Gy patients, 155 (15·4%) of 1005 27 Gy patients, and 121 of 1020 (11·9%) 26 Gy patients. Across all clinician assessments from 1-5 years, odds ratios versus 40 Gy in 15 fractions were 1·55 (95% CI 1·32 to 1·83, p<0·0001) for 27 Gy in five fractions and 1·12 (0·94 to 1·34, p=0·20) for 26 Gy in five fractions. Patient and photographic assessments showed higher normal tissue effect risk for 27 Gy versus 40 Gy but not for 26 Gy versus 40 Gy. INTERPRETATION 26 Gy in five fractions over 1 week is non-inferior to the standard of 40 Gy in 15 fractions over 3 weeks for local tumour control, and is as safe in terms of normal tissue effects up to 5 years for patients prescribed adjuvant local radiotherapy after primary surgery for early-stage breast cancer. FUNDING National Institute for Health Research Health Technology Assessment Programme.",2020,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"['Between Nov 24, 2011, and June 19, 2014', '4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule', 'Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible', '97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK']","['adjuvant radiotherapy (radiation therapy', 'adjuvant local radiotherapy', 'Hypofractionated breast radiotherapy']","['normal tissue effect risk', 'Normal tissue effects', 'ipsilateral breast tumour relapse', 'moderate or marked clinician-assessed normal tissue effects', '5-year incidence for 40 Gy, non-inferiority', 'incidence of ipsilateral breast tumour relapse']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}]",4096.0,0.236289,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Murray Brunt', 'Affiliation': 'University Hospitals of North Midlands and University of Keele, Stoke on Trent, UK; Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK. Electronic address: fastforward-icrctsu@icr.ac.uk.'}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Haviland', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Duncan A', 'Initials': 'DA', 'LastName': 'Wheatley', 'Affiliation': 'Royal Cornwall Hospital, Treliske, Truro, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Sydenham', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alhasso', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bloomfield', 'Affiliation': 'Brighton and Sussex University Hospitals, Brighton, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Nuffield Health Cheltenham Hospital, Cheltenham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Churn', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cleator', 'Affiliation': 'Imperial Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Coles', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK; Torbay Hospital NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Harnett', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Hopwood', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kirby', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'Zohal', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Sawyer', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Navita', 'Initials': 'N', 'LastName': 'Somaiah', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Liba', 'Initials': 'L', 'LastName': 'Stones', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Clatterbridge Cancer Centre, Bebington, Wirral, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Yarnold', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30932-6'] 2583,32580978,Hepatic venous pressure gradient-guided laparoscopic splenectomy and pericardial devascularisation versus endoscopic therapy for secondary prophylaxis for variceal rebleeding in portal hypertension (CHESS1803): study protocol of a multicenter randomised controlled trial in China.,"INTRODUCTION Gastro-oesophageal variceal bleeding is one of the most common and severe complications with high mortality in cirrhotic patients who developed portal hypertension. Hepatic venous pressure gradient (HVPG) is a globally recommended golden standard for the portal pressure assessment and an HVPG ≥16 mm Hg indicates a higher risk of death and rebleeding. This study aims to compare the effectiveness and safety of splenectomy and pericardial devascularisation (laparoscopic therapy) plus propranolol and endoscopic therapy plus propranolol for variceal rebleeding in cirrhotic patients with HVPG between 16 and 20 mm Hg. METHODS AND ANALYSIS This is a multicenter, randomised, controlled clinical trial. Participants will be 1:1 assigned randomly into either laparoscopic or endoscopic groups. Forty participants whose transjugular HVPG lies between 16 and 20 mm Hg with a history of gastro-oesophageal variceal bleeding will be recruited from three sites in China. Participants will receive either endoscopic therapy plus propranolol or laparoscopic therapy plus propranolol. The primary outcome measure will be the occurrence of gastro-oesophageal variceal rebleeding. Secondary outcome measures will include overall survival, occurrence of hepatocellular carcinoma, the occurrence of venous thrombosis, the occurrence of adverse events, quality of life and tolerability of treatment. Outcome measures will be evaluated at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks and 60 weeks. Multivariate COX regression model will be introduced for analyses of occurrence data and Kaplan-Meier analysis with the log-rank test for intergroup comparison. ETHICS AND DISSEMINATION Ethical approval was obtained from all three participating sites. Primary and secondary outcome data will be submitted for publication in peer-reviewed journals and widely disseminated. TRIAL REGISTRATION NUMBER NCT03783065; Pre-results. TRIAL STATUS Recruitment for this study started in December 2018 while the first participant was randomised in January 2019. Recruitment is estimated to stop in October 2019.",2020,Hepatic venous pressure gradient (HVPG) is a globally recommended golden standard for the portal pressure assessment and an HVPG ≥16 mm Hg indicates a higher risk of death and rebleeding.,"['Recruitment for this study started in December 2018 while the first participant was randomised in January 2019', 'Forty participants whose transjugular HVPG lies between 16 and 20\u2009mm Hg with a history of gastro-oesophageal variceal bleeding will be recruited from three sites in China', 'cirrhotic patients who developed portal hypertension', 'cirrhotic patients with HVPG between 16 and 20\u2009mm Hg']","['Hepatic venous pressure gradient-guided laparoscopic splenectomy and pericardial devascularisation versus endoscopic therapy', 'laparoscopic or endoscopic groups', 'Hepatic venous pressure gradient (HVPG', 'endoscopic therapy plus propranolol or laparoscopic therapy plus propranolol', 'splenectomy and pericardial devascularisation (laparoscopic therapy) plus propranolol and endoscopic therapy plus propranolol']","['occurrence of gastro-oesophageal variceal rebleeding', 'variceal rebleeding', 'overall survival, occurrence of hepatocellular carcinoma, the occurrence of venous thrombosis, the occurrence of adverse events, quality of life and tolerability of treatment', 'submitted for publication in peer-reviewed journals and widely disseminated']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]","[{'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0581712', 'cui_str': 'Devascularization - action'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}]",,0.224228,Hepatic venous pressure gradient (HVPG) is a globally recommended golden standard for the portal pressure assessment and an HVPG ≥16 mm Hg indicates a higher risk of death and rebleeding.,"[{'ForeName': 'Ruoyang', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Hepatobiliary Surgery, The Third People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Jitao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, Xingtai Institute of Cancer Control, Xingtai, China.'}, {'ForeName': 'Ruizhao', 'Initials': 'R', 'LastName': 'Qi', 'Affiliation': 'Department of General Surgery, The Fifth Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatobiliary Surgery, Shunde Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Shunde Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Hepatobiliary Surgery, The Third People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Changzeng', 'Initials': 'C', 'LastName': 'Zuo', 'Affiliation': 'Department of Hepatobiliary Surgery, Xingtai Institute of Cancer Control, Xingtai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, Shunde Hospital, Southern Medical University, Foshan, China qixiaolong@vip.163.com weiweih@126.com.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China qixiaolong@vip.163.com weiweih@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-030960'] 2584,32469920,Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation.,"INTRODUCTION Simulation is a powerful tool for training and evaluating clinicians. However, few studies have examined the consistency of actor performances during simulation based medical education (SBME). The Simulated Communication with ICU Proxies trial (ClinicalTrials.gov NCT02721810) used simulation to evaluate the effect of a behavioral intervention on physician communication. The purpose of this secondary analysis of data generated by the quality assurance team during the trial was to assess how quality assurance monitoring procedures impacted rates of actor errors during simulations. METHODS The trial used rigorous quality assurance to train actors, evaluate performances, and ensure the intervention was delivered within a standardized environment. The quality assurance team evaluated video recordings and documented errors. Actors received both timely, formative feedback and participated in group feedback sessions. RESULTS Error rates varied significantly across three actors (H(2) = 8.22, p = 0.02). In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42). CONCLUSIONS Rigorous quality assurance procedures may help ensure consistent actor performances during SBME.",2020,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42). ",[],"['Actor feedback and rigorous monitoring', 'behavioral intervention']","['incidence of actor error over time, and errors', 'Error rates']",[],"[{'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0672195,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42). ","[{'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Abshire', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Pragyashree Sharma', 'Initials': 'PS', 'LastName': 'Basyal', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Teply', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United States of America.'}, {'ForeName': 'Arun L', 'Initials': 'AL', 'LastName': 'Singh', 'Affiliation': ""Division of Pediatric Palliative Medicine, Prisma Health Children's Hopsital - Upstate, University of South Carolina School of Medicine - Greenville, Greenville, South Carolina, United States of America.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Hayes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PloS one,['10.1371/journal.pone.0233538'] 2585,32579859,Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-Face Therapy.,"Purpose Previous studies have reported that voice therapy via telepractice is useful for patients with nodules and muscle tension dysphonia. Nevertheless, telepractice for elderly patients with voice disorders has not yet been investigated. We conducted this study to examine the hypothesis that voice therapy via telepractice is not inferior to conventional voice therapy. Method Eighty patients with dysphonia aged more than 55 years participated in this study from September 2016 to June 2018. After screening the inclusion and the exclusion criteria, 69 patients were randomized into telepractice (33 patients) and conventional (36 patients) groups. The outcome measurements included Voice Handicap Index-10, videolaryngostroboscopy, maximum phonation time, auditory-perceptual evaluation, and acoustic analysis. Paired t test, Wilcoxon signed-ranks test, and repeated measures analysis of variance were used to examine treatment outcomes. Results The diagnoses of voice disorders included atrophy ( n = 33), unilateral vocal paralysis ( n = 13), muscle tension dysphonia ( n = 7), nodules ( n = 6), and polyps ( n = 10). No significant differences were observed in age, sex, and baseline measurements between the two groups. Twenty-five patients in the telepractice group and 24 patients in the control group completed at least four weekly sessions. Significant improvements were observed for all the outcome measures ( p < .05) in both groups. Improvements in Voice Handicap Index-10 in the telepractice group (24.84 ± 5.49 to 16.80 ± 8.94) were comparable to those in the conventional group (22.17 ± 7.29 to 13.46 ± 9.95, p = .764). Other parameters also showed comparable improvements between the two groups without statistically significant differences. Conclusions This is the first randomized controlled trial comparing telepractice and conventional voice therapy in elderly patients with voice disorders. The results showed that the effectiveness of voice therapy via telepractice was not inferior to that of conventional voice therapy, indicating that telepractice can be used as an alternative to provide voice care for elderly patients with vocal disorders.",2020,"Improvements in Voice Handicap Index-10 in the telepractice group (24.84 ± 5.49 to 16.80 ± 8.94) were comparable to those in the conventional group (22.17 ± 7.29 to 13.46 ± 9.95, p = .764).","['Method Eighty patients with dysphonia aged more than 55 years participated in this study from September 2016 to June 2018', 'voice disorders included atrophy ( n = 33), unilateral vocal paralysis ( n = 13), muscle tension dysphonia ( n = 7), nodules ( n = 6), and polyps ( n = 10', 'Benign Voice Disorders in the Elderly', 'elderly patients with vocal disorders', 'elderly patients with voice disorders', 'patients with nodules and muscle tension dysphonia', '69 patients were randomized into telepractice (33 patients) and conventional (36 patients) groups']","['Voice Therapy', 'Telepractice and Conventional Face-to-Face Therapy', 'telepractice and conventional voice therapy']","['Voice Handicap Index-10', 'Voice Handicap Index-10, videolaryngostroboscopy, maximum phonation time, auditory-perceptual evaluation, and acoustic analysis']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C4728018', 'cui_str': 'Muscle tension dysphonia'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",80.0,0.0331451,"Improvements in Voice Handicap Index-10 in the telepractice group (24.84 ± 5.49 to 16.80 ± 8.94) were comparable to those in the conventional group (22.17 ± 7.29 to 13.46 ± 9.95, p = .764).","[{'ForeName': 'Feng-Chuan', 'Initials': 'FC', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsin-Yu', 'Initials': 'HY', 'LastName': 'Chien', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, Asia University, Taichung, Taiwan.'}, {'ForeName': 'Sheng Hwa', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, Asia University, Taichung, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Kao', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Po-Wen', 'Initials': 'PW', 'LastName': 'Cheng', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Te', 'Initials': 'CT', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Far Eastern Memorial Hospital, Taipei, Taiwan.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00364'] 2586,32579971,When the camera eats first: Exploring how meal-time cell phone photography affects eating behaviours.,"Advances in cell phone technology have the potential to disrupt eating patterns. In this research, we focused on the camera function of a cell phone, characterizing: (i) the extent to which this function is used during meals; (ii) whether meal-time photographers show signs of pathological eating; and (iii) whether the act of taking food photographs alters the amount and enjoyment of food eaten. In the first study, we used the experience sampling method to track one week of meals from 137 young adults. Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not. That is, these meal-time photographers were more likely to eat in response to external cues (e.g. the sight of palatable food) than to internal cues of hunger. However, when participants were randomly assigned to take either food or non-food photographs within a lab setting (Study 2), we found no evidence that the type of photography influenced either the amount or enjoyment of food eaten. Taken together, our findings suggest a limited role for cell phone photography in an obesogenic environment.",2020,"Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not.",['137 young adults'],"['type of photography influenced either the amount or enjoyment of food eaten', 'food or non-food photographs']",['external eating scores'],"[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",137.0,0.0170038,"Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not.","[{'ForeName': 'Joceline Y Y', 'Initials': 'JYY', 'LastName': 'Yong', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, 16 College Avenue West, Singapore, 138527, Singapore.'}, {'ForeName': 'Eddie M W', 'Initials': 'EMW', 'LastName': 'Tong', 'Affiliation': 'Department of Psychology, National University of Singapore, 9 Arts Link, Singapore, 117572, Singapore.'}, {'ForeName': 'Jean C J', 'Initials': 'JCJ', 'LastName': 'Liu', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, 16 College Avenue West, Singapore, 138527, Singapore; Neuroscience and Behavioral Disorders Programme, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. Electronic address: jeanliu@yale-nus.edu.sg.'}]",Appetite,['10.1016/j.appet.2020.104787'] 2587,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling. METHODS The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico. DISCUSSION Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings. TRIAL REGISTRATION This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067'] 2588,22479610,Experimental study of informal rewards in peer production.,"We test the effects of informal rewards in online peer production. Using a randomized, experimental design, we assigned editing awards or ""barnstars"" to a subset of the 1% most productive Wikipedia contributors. Comparison with the control group shows that receiving a barnstar increases productivity by 60% and makes contributors six times more likely to receive additional barnstars from other community members, revealing that informal rewards significantly impact individual effort.",2012,"Comparison with the control group shows that receiving a barnstar increases productivity by 60% and makes contributors six times more likely to receive additional barnstars from other community members, revealing that informal rewards significantly impact individual effort.",[],[],[],[],[],[],,0.0181126,"Comparison with the control group shows that receiving a barnstar increases productivity by 60% and makes contributors six times more likely to receive additional barnstars from other community members, revealing that informal rewards significantly impact individual effort.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Restivo', 'Affiliation': 'Department of Sociology, State University of New York at Stony Brook, New York, New York, United States of America. michael.restivo@stonybrook.edu'}, {'ForeName': 'Arnout', 'Initials': 'A', 'LastName': 'van de Rijt', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0034358'] 2589,32447743,Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety.,"INTRODUCTION Although use of contraception was pre-specified during cladribine clinical trials for multiple sclerosis, some pregnancies did occur. OBJECTIVE This analysis reports on pregnancy outcomes in the cladribine clinical development program. METHODS Pregnancy outcomes in female patients (direct pregnancies) and those arising from partner pregnancies (i.e., female partners of male study participants with multiple sclerosis) were evaluated from an integrated safety analysis of ten studies of cladribine in multiple sclerosis (nine clinical trials and a long-term safety registry), with patients treated with cladribine tablets, parenteral cladribine, or placebo (all-exposed cohort; 1976 patients received cladribine and 802 received placebo). Pregnancies that occurred during the 'at-risk' period for cladribine (during treatment or within 6 months thereafter) are reported as a separate group. RESULTS In the all-exposed cohort, 70 direct pregnancies occurred among 62 female patients (cladribine, n = 49; placebo, n = 21). Pregnancy outcomes were: live births (cladribine, n = 19 [38.8%]; placebo, n = 9 [42.9%]), elective terminations (cladribine, n = 14 [28.6%]; placebo, n = 4 [19.0%]), spontaneous abortions (cladribine, n = 11 [22.4%]; placebo, n = 5 [23.8%]), and therapeutic terminations (cladribine, n = 5 [10.2%]; placebo, n = 2 [9.5%]); in the remaining placebo recipient, the pregnancy outcome was unknown. There were two reports of congenital malformations (cladribine, n = 1; placebo, n = 1), both of which occurred with pregnancies arising > 2 years after exposure to the last dose of study medication. Sixteen direct pregnancies occurred during the 'at-risk' period for cladribine; outcomes for these were: live births, n = 3 (18.8%); elective terminations, n = 10 (62.5%); spontaneous abortions, n = 2 (12.5%); and therapeutic terminations, n = 1 (6.2%). Corresponding findings for direct pregnancies among placebo recipients were (n = 11): live births, n = 5 (45.5%); elective terminations, n = 2 (18.2%); spontaneous abortions, n = 3 (27.3%); and unknown, n = 1 (9.1%). No cases of congenital malformation were reported for pregnancies during the 'at-risk' period. There were an additional nine partner pregnancies in female partners of cladribine-treated male patients, all of which resulted in live births; of these, two pregnancies occurred within the 'at-risk' period for cladribine. CONCLUSIONS While limited by the small number of pregnancies and related data from the cladribine clinical development program, highlighting the need for further study, the observations made in the present analysis were generally consistent with epidemiological data on pregnancy outcomes for the general population or women with multiple sclerosis. There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose. As the data available for cladribine-exposed pregnancies in patients with multiple sclerosis are limited, a non-interventional post-authorization safety study has been initiated to obtain more information on this subject. CLINICAL TRIAL REGISTRATION CLARITY: NCT00213135; CLARITY Extension: NCT00641537; ORACLE MS: NCT00725985; ONWARD: NCT00436826; PREMIERE: NCT01013350.",2020,There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose.,"['all-exposed cohort; 1976 patients received', 'female patients (direct pregnancies) and those arising from partner pregnancies (i.e., female partners of male study participants with multiple sclerosis', '62 female patients', 'Multiple Sclerosis', 'patients with multiple sclerosis', 'in multiple sclerosis (nine clinical trials and a long-term safety registry), with patients treated with', 'general population or women with multiple sclerosis']","['cladribine', 'cladribine tablets, parenteral cladribine, or placebo', 'cladribine and 802 received placebo', 'Cladribine', 'placebo']","['congenital malformation', 'Pregnancy Outcomes', 'congenital malformations', 'elective terminations', 'therapeutic terminations', 'live births', 'spontaneous abortions']","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0919624', 'cui_str': 'Pregnancy of partner'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.0987172,There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose.,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT, UK. g.giovannoni@qmul.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Galazka', 'Affiliation': 'Merck, Aubonne, Switzerland, a division of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Schick', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leist', 'Affiliation': 'Comprehensive MS Center, Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Division of Neurology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Damian', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'New Jersey Medical School, Rutgers, The State University of New Jersey, Newark, NJ, USA.'}]",Drug safety,['10.1007/s40264-020-00948-x'] 2590,32447767,"Efficacy and safety of Jessner's solution peel in comparison with salicylic acid 30% peel in the management of patients with acne vulgaris and postacne hyperpigmentation with skin of color: a randomized, double-blinded, split-face, controlled trial.","OBJECTIVE Antibiotics and retinoids have been used for acne vulgaris for decades. Though effective, each has its own drawbacks. Chemical peels have been used for treatment of acne vulgaris with inadequate clinical evidence. We sought to determine the efficacy and safety of Jessner's solution (JS) in comparison with salicylic acid (SA) 30% in the management of acne vulgaris and postacne hyperpigmentation in patients with colored skin. METHODS A total of 36 subjects (94.5% Fitzpatick Type IV-V) were recruited in this randomized double-blinded, split-face, controlled trial. Each side of the face was randomly assigned for treatment with either JS or SA. Subjects were treated once fortnightly for a total of three sessions. Lesion counting, Michaelsson acne score (MAS), photographs, and postacne hyperpigmentation index (PAHPI) were used to objectively assess the improvement. Complications were assessed during each visit. Statistical analysis was conducted using SPSS v22.0. Significance was set at P = 0.05. RESULTS At the end of therapy, significant reduction in inflammatory, noninflammatory lesions, MAS, and PAHPI scores (P < 0.001, respectively) were noted in comparison to baseline. Mixed model analysis revealed no significant outcome difference between the two groups. Patients who reported good and very good outcome were 76.4% (JS) and 85.3% (SA). Burning, stinging sensation, and exfoliation were the common complications reported. Postinflammatory hyperpigmentation was reported only once in the JS arm. CONCLUSION Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.",2020,Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.,"['patients with colored skin', 'patients with acne vulgaris and postacne hyperpigmentation with skin of color', '36 subjects (94.5% Fitzpatick Type IV-V']","['salicylic acid (SA', ""Jessner's solution (JS"", 'JS or SA', ""Jessner's solution peel"", 'salicylic acid 30% peel']","['Burning, stinging sensation, and exfoliation', 'Lesion counting, Michaelsson acne score (MAS), photographs, and postacne hyperpigmentation index (PAHPI', 'postacne hyperpigmentation', 'Complications', 'inflammatory, noninflammatory lesions, MAS, and PAHPI scores', 'Postinflammatory hyperpigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}]","[{'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0064150', 'cui_str': ""Jessner's solution""}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0040439', 'cui_str': 'Exfoliation of teeth'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}]",36.0,0.238022,Both JS and SA were equally effective in the treatment of acne vulgaris and reducing postacne hyperpigmentation in patients with colored skin.,"[{'ForeName': 'Kang N', 'Initials': 'KN', 'LastName': 'How', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Poh Y', 'Initials': 'PY', 'LastName': 'Lim', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra, Serdang, Malaysia.'}, {'ForeName': 'Wan Syazween Lyana', 'Initials': 'WSL', 'LastName': 'Wan Ahmad Kammal', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Norashikin', 'Initials': 'N', 'LastName': 'Shamsudin', 'Affiliation': 'Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}]",International journal of dermatology,['10.1111/ijd.14948'] 2591,32447799,"An extra virgin olive oil-enriched diet improves maternal, placental, and cord blood parameters in GDM pregnancies.","AIMS To address the effect of a diet enriched in extra virgin olive oil (EVOO) on maternal metabolic parameters and placental proinflammatory markers in Gestational diabetes mellitus (GDM) patients. METHODS Pregnant women at 24-28 weeks of gestation were enrolled: 33 GDM patients which were randomly assigned or not to the EVOO-enriched group and 17 healthy controls. Metabolic parameters were determined. Peroxisome proliferator activated receptor (PPAR) γ and PPARα protein expression, expression of microRNA (miR)-130a and miR-518d (which respectively target these PPAR isoforms) and levels of proinflammatory markers were evaluated in term placentas. Matrix metalloproteinases (MMPs) activity was evaluated in term placentas and umbilical cord blood. RESULTS GDM patients that received the EVOO-enriched diet showed reduced pregnancy weight gain (GDM-EVOO:10.3 ± 0.9, GDM:14.2 ± 1.4, P = .03) and reduced triglyceridemia (GDM-EVOO:231 ± 14, GDM:292 ± 21, P = .02) compared to the non-EVOO-enriched GDM group. In GDM placentas, the EVOO-enriched diet did not regulate PPARγ protein expression or miR-130a expression, but prevented the reduced PPARα protein expression (P = .02 vs GDM) and the increased miR-518d expression (P = .009 vs GDM). Increased proinflammatory markers (interleukin-1β, tumour necrosis factor-α and nitric oxide overproduction) in GDM placentas were prevented by the EVOO-enriched diet (respectively P = .001, P = .001 and P = .01 vs GDM). MMPs overactivity was prevented in placenta and umbilical cord blood in the EVOO-enriched GDM group (MMP-9: respectively P = .01 and P = .001 vs GDM). CONCLUSIONS A diet enriched in EVOO in GDM patients reduced maternal triglyceridemia and weight gain and has antiinflammatory properties in placenta and umbilical cord blood, possibly mediated by the regulation of PPAR pathways.",2020,"Increased proinflammatory markers (interleukin-1β, tumor necrosis factor-α and nitric oxide overproduction) in GDM placentas were prevented by the EVOO-enriched diet (respectively P=0.001, P=0.001 and P=0.01 vs GDM).","['Pregnant women at 24-28\u2009weeks of gestation were enrolled: 33 GDM patients which were randomly assigned or not to the EVOO-enriched group and 17 healthy controls', 'GDM pregnancies', 'Gestational diabetes mellitus (GDM) patients']","['extra virgin olive oil-enriched diet', 'diet enriched in extra virgin olive oil (EVOO']","['maternal triglyceridemia and weight gain', 'placenta and umbilical cord blood', 'miR-518d expression', 'Peroxisome proliferator activated receptor (PPAR', 'reduced triglyceridemia', 'reduced PPARα protein expression', 'PPARγ protein expression or miR-130a expression', 'Matrix metalloproteinases (MMPs) activity', 'Increased proinflammatory markers (interleukin-1β, tumor necrosis factor-α and nitric oxide overproduction) in GDM placentas', 'MMPs overactivity', 'maternal metabolic parameters and placental proinflammatory markers', 'γ and PPARα protein expression, expression of microRNA', 'Metabolic parameters', 'pregnancy weight gain', 'maternal, placental and cord blood parameters']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0474395', 'cui_str': 'Behavior showing increased motor activity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",33.0,0.0285214,"Increased proinflammatory markers (interleukin-1β, tumor necrosis factor-α and nitric oxide overproduction) in GDM placentas were prevented by the EVOO-enriched diet (respectively P=0.001, P=0.001 and P=0.01 vs GDM).","[{'ForeName': 'Dalmiro', 'Initials': 'D', 'LastName': 'Gomez Ribot', 'Affiliation': 'Universidad de Buenos Aires (UBA), Facultad de Medicina, Buenos Aires, Argentina.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Diaz', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Fazio', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Hebe Lorena', 'Initials': 'HL', 'LastName': 'Gómez', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Daiana', 'Initials': 'D', 'LastName': 'Fornes', 'Affiliation': 'Universidad de Buenos Aires (UBA), Facultad de Medicina, Buenos Aires, Argentina.'}, {'ForeName': 'Silvia Beatriz', 'Initials': 'SB', 'LastName': 'Macchi', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Gresta', 'Affiliation': 'Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina.'}, {'ForeName': 'Evangelina', 'Initials': 'E', 'LastName': 'Capobianco', 'Affiliation': 'Universidad de Buenos Aires (UBA), Facultad de Medicina, Buenos Aires, Argentina.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jawerbaum', 'Affiliation': 'Universidad de Buenos Aires (UBA), Facultad de Medicina, Buenos Aires, Argentina.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3349'] 2592,32450083,Randomized matrix games in a finite population: Effect of stochastic fluctuations in the payoffs on the evolution of cooperation.,"A diffusion approximation for a randomized 2 × 2-matrix game in a large finite population is ascertained in the case of random payoffs whose expected values, variances and covariances are of order given by the inverse of the population size N. Applying the approximation to a Randomized Prisoner's Dilemma (RPD) with independent payoffs for cooperation and defection in random pairwise interactions, conditions on the variances of the payoffs for selection to favor the evolution of cooperation, favor more the evolution of cooperation than the evolution of defection, and disfavor the evolution of defection are deduced. All these are obtained from probabilities of ultimate fixation of a single mutant. It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection. A RPD game with independent payoffs whose expected values are additive is studied in detail to support the conclusions. Randomized matrix games with non-independent payoffs, namely the RPD game with additive payoffs for cooperation and defection based on random cost and benefit for cooperation and the repeated RPD game with Tit-for-Tat and Always-Defect as strategies in pairwise interactions with a random number of rounds, are studied under the assumption that the population-scaled expected values, variances and covariances of the payoffs are all of the same small enough order. In the first model, the conditions in favor of the evolution of cooperation hold only if the covariance between the cost and the benefit is large enough, while the analysis of the second model extends the results on the effects of the variances of the payoffs for cooperation and defection found for the one-round RPD game.",2020,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,[],[],[],[],[],[],,0.0254081,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Lessard', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada. Electronic address: lessards@dms.umontreal.ca.'}]",Theoretical population biology,['10.1016/j.tpb.2020.04.006'] 2593,32454209,"Psilocybin acutely alters the functional connectivity of the claustrum with brain networks that support perception, memory, and attention.","Psychedelic drugs, including the serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin, are receiving renewed attention for their possible efficacy in treating a variety of neuropsychiatric disorders. Psilocybin induces widespread dysregulation of cortical activity, but circuit-level mechanisms underlying this effect are unclear. The claustrum is a subcortical nucleus that highly expresses 5-HT 2A receptors and provides glutamatergic inputs to arguably all areas of the cerebral cortex. We therefore tested the hypothesis that psilocybin modulates claustrum function in humans. Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100 ​min after blinded oral administration of placebo and 10 mg/70 ​kg psilocybin. Left and right claustrum signal was isolated using small region confound correction. Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum. Psilocybin also significantly decreased functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity with the fronto-parietal task control network (FPTC), and decreased left claustrum connectivity with the FPTC. DMN integrity was associated with right-claustrum connectivity with the DMN, while FPTC integrity and modularity were associated with right claustrum and left claustrum connectivity with the FPTC, respectively. Subjective effects of psilocybin predicted changes in the amplitude of low frequency fluctuations and the variance of BOLD signal in the left and right claustrum. Observed effects were specific to claustrum, compared to flanking regions of interest (the left and right insula and putamen). This study used a pharmacological intervention to provide the first empirical evidence in any species for a significant role of 5-HT 2A receptor signaling in claustrum functioning, and supports a possible role of the claustrum in the subjective and therapeutic effects of psilocybin.",2020,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"['Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100\u202fmin after blinded oral administration of', 'humans']","['psilocybin', 'placebo and 10 mg/70\u202fkg psilocybin', 'Psilocybin', 'serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin']","['BOLD signal', 'amplitude of low frequency fluctuations', 'functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008910', 'cui_str': 'Claustral structure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",15.0,0.0313229,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"[{'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA. Electronic address: fbarrett@jhmi.edu.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Department of Neuroscience, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Mathur', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Maryland, Baltimore, MD, 21201, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116980'] 2594,32454239,Randomized clinical trial of radiofrequency-induced thermotherapy combined with transilluminated powered phlebectomy versus high ligation and stripping for the treatment of lower limb varicose veins.,"OBJECTIVE The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP. METHODS The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications. RESULTS The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ 2  = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other. CONCLUSIONS RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.",2020,"There were no significantly differences between the two groups in DVT, phlebitis, haematomas, pain and infection.","['Lower Limb Varicose Veins', 'patients with lower limb VVs']","['Radiofrequency Induced Thermotherapy', 'RFiTT', 'Transilluminated Powered Phlebectomy versus High Ligation and Stripping', 'RFiTT combined with TIPP', 'HLS', 'high ligation and stripping (HLS) combined with TIPP', 'RFiTT combined with TIPP group or HLS combined with TIPP', 'radiofrequency induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP']","['VCSS scores', 'DVT, phlebitis, haematomas, pain and infection', 'CIVIQ-14 scores', 'efficacy and safety', 'Operation time, intraoperative blood loss, duration in hospital, duration in bed, resumption of activities', 'Venous Clinical Severity Score (VCSS), Chronic Venous Insufficiency Questionnaire (CIVIQ-14) scores changes at 12 months and perioperative complications', 'total closure rate of GSV', 'But skin pigmentation and paresthesia', 'total closure rate of great saphenous vein (GSV']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0191017', 'cui_str': 'Excision of vein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",,0.051101,"There were no significantly differences between the two groups in DVT, phlebitis, haematomas, pain and infection.","[{'ForeName': 'Chuan-Jun', 'Initials': 'CJ', 'LastName': 'Liao', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Sheng-Han', 'Initials': 'SH', 'LastName': 'Song', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wang-de', 'Initials': 'WD', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. Electronic address: zhangwang_de@163.com.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.04.028'] 2595,32454259,An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction.,"Percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP) are widely accepted but competing approaches for the management of malignant obstruction at the hilum of the liver. ERCP is favored in the United States on the basis of high success rates for non-hilar indications, the perceived safety and superior tissue sampling capability of ERCP relative to PTBD, and the avoidance of external drains that are undesirable to patients. A recent randomized controlled trial (RCT) comparing the 2 modalities in patients with resectable hilar cholangiocarcinoma was terminated prematurely because of higher mortality in the PTBD group. 1 In contrast, most observational data suggest that PTBD is superior for achieving complete drainage. 2-6 Because the preferred procedure remains uncertain, we aimed to compare PTBD and ERCP as the primary intervention in patients with cholestasis due to malignant hilar obstruction (MHO).",2020,,['Suspected Malignant Hilar Obstruction'],['Percutaneous vs Endoscopic Drainage'],[],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",[],,0.0860146,,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina. Electronic address: elmunzer@musc.edu.'}, {'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Smith', 'Affiliation': 'Division of Gastroenterology and Liver Disease, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tarnasky', 'Affiliation': 'Division of Gastroenterology, Methodist Dallas Medical Center, Dallas, Texas.'}, {'ForeName': 'Andrew Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Yachimski', 'Affiliation': 'Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Banovac', 'Affiliation': 'Division of Interventional Radiology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Buscaglia', 'Affiliation': 'Division of Gastroenterology, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Buxbaum', 'Affiliation': 'Division of Gastroenterology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology and Liver Disease, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Chong', 'Affiliation': 'Division of Gastroenterology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Draganov', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Kulwinder', 'Initials': 'K', 'LastName': 'Dua', 'Affiliation': 'Division of Gastroenterology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Geller', 'Affiliation': 'Division of Interventional Radiology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Laith H', 'Initials': 'LH', 'LastName': 'Jamil', 'Affiliation': 'Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Rajesh N', 'Initials': 'RN', 'LastName': 'Keswani', 'Affiliation': 'Division of Gastroenterology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mouen A', 'Initials': 'MA', 'LastName': 'Khashab', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Law', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Lo', 'Affiliation': 'Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Division of Gastroenterology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'J Bayne', 'Initials': 'JB', 'LastName': 'Selby', 'Affiliation': 'Division of Interventional Radiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Taylor', 'Affiliation': 'Division of Gastroenterology, Saint Louis University, St Louis, Missouri.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.035'] 2596,32462958,Cost-effectiveness analysis of pembrolizumab monotherapy versus chemotherapy for previously untreated advanced non-small cell lung cancer.,"Objective: To assess the cost-effectiveness of pembrolizumab monotherapy compared with standard chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in previously untreated adults who have a high programmed death ligand 1 (PD-L1) tumor proportion score of 50% or greater in Singapore. Materials and methods: A partitioned-survival analysis model was developed from a healthcare system's perspective that extrapolated clinical and economic outcomes of first-line pembrolizumab (maximum treatment duration of 2 years) versus platinum doublet chemotherapy over a 10-year time horizon for patients with advanced NSCLC. The model consisted of three health states: alive with no progression, alive with progression, and dead. Key clinical inputs were based on Kaplan-Meier survival curves from the interim (median follow-up = 11.2 months) and updated analysis (median follow-up = 25.2 months) of the KEYNOTE-024 randomized controlled trial. Local cost data were applied. Utilities were derived from published international estimates. Both one-way and multivariate probabilistic sensitivity analyses (PSA) were conducted to identify key drivers of the results. Results: Using the results from the updated analysis of KEYNOTE-024, patients treated with pembrolizumab experienced more quality adjusted life-years (QALYs), but incurred higher costs compared to chemotherapy over a 10-year time horizon (pembrolizumab: 1.9983 QALYs, SGD215,761; chemotherapy: 1.1317 QALYs, SGD70,444). The base-case incremental cost-effectiveness ratio (ICER) was SGD167,692 per QALY gained. One-way sensitivity analysis showed the ICER was most sensitive to the cost of pembrolizumab, followed by the time horizon. Multivariate PSA indicated that pembrolizumab had 0% probability of being cost-effective at a hypothetical willingness-to-pay threshold of SGD100,000 per QALY gained. Conclusion: While pembrolizumab is superior to standard chemotherapy in improving overall survival and progression-free survival, results suggest that it is unlikely to be cost-effective at its current price in Singapore. Factors including clinical effectiveness, safety, and budget impact should also be considered when making national funding decisions.",2020,"The base-case incremental cost-effectiveness ratio (ICER) was SGD167,692 per QALY gained.","['previously untreated advanced non-small cell lung cancer', 'advanced non-small cell lung cancer (NSCLC) in previously untreated adults who have a high programmed death ligand 1 (PD-L1) tumor proportion score of 50% or greater in Singapore', 'patients with advanced NSCLC']","['pembrolizumab monotherapy versus chemotherapy', 'pembrolizumab monotherapy', 'standard chemotherapy', 'pembrolizumab', 'platinum doublet chemotherapy']","['quality adjusted life-years (QALYs', 'clinical effectiveness, safety and budget impact', 'cost-effectiveness', 'overall survival and progression-free survival', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.169454,"The base-case incremental cost-effectiveness ratio (ICER) was SGD167,692 per QALY gained.","[{'ForeName': 'Mohamed Ismail Abdul', 'Initials': 'MIA', 'LastName': 'Aziz', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore.'}, {'ForeName': 'Ling Eng', 'Initials': 'LE', 'LastName': 'Tan', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore.'}, {'ForeName': 'Wan Hui Gloria', 'Initials': 'WHG', 'LastName': 'Tan', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore.'}, {'ForeName': 'Chee-Keong', 'Initials': 'CK', 'LastName': 'Toh', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre, Singapore, Singapore.'}, {'ForeName': 'Lydia Pui Yee', 'Initials': 'LPY', 'LastName': 'Loke', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore.'}, {'ForeName': 'Kwong', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore.'}]",Journal of medical economics,['10.1080/13696998.2020.1775620'] 2597,32463404,Effects of the apple matrix on the postprandial bioavailability of flavan-3-ols and nutrigenomic response of apple polyphenols in minipigs challenged with a high fat meal.,"Food matrix interactions with polyphenols can affect their bioavailability and as a consequence may modulate their biological effects. The aim of this study was to determine if the matrix and its processing would modulate the bioavailability and the postprandial nutrigenomic response to a dietary inflammatory stress of apple flavan-3-ol monomers. We carried out an acute randomized controlled study in minipigs challenged with a high fat meal (HFM) supplemented with raw fruit, puree, or apple phenolic extract with matched content of flavan-3-ol monomers. Fasting and postprandial blood samples were collected over 3 h to quantify flavan-3-ol monomers in sera by UPLC-Q-TOF/MS and to isolate peripheral blood mononuclear cells (PBMCs) for assessing the changes in the gene expression profile using a microarray analysis. When compared to the extract-supplemented meal, the peak of the total flavan-3-ol concentration was reduced by half with both raw apple and puree supplements. The apple matrices also affected the gene expression profile as revealed by the Principal Component Analysis of the microarray data from PBMCs which discriminated the supplementation of HFM with the polyphenol extract from those with raw apples or puree. A total of 309 genes were identified as differentially expressed by the apple-derived products compared to HFM, with 63% modulated only in the presence of the food matrix (apple and puree). The number of differentially modulated genes was higher with the puree (246) than with the unprocessed apple (182). Pathway enrichment analyses revealed that genes affected by the apple-derived products control inflammation and leukocyte transendothelial migration both involved in the onset of atherosclerotic processes. Overall, this study showed that the two apple matrices reduce the postprandial serum concentration of flavon-3-ols whereas they increase the nutrigenomic response of PBMCs. The biological processes identified as modulated by the apple products suggest an attenuation of the transient pro-inflammatory response induced by a HFM. The differences observed between the nutrigenomic responses support that the apple matrix and its processing affect the nutrigenomic response, probably by increasing the bioavailability of other apple phytochemicals. To conclude, this study raises awareness for considering the impact of the food matrix and its processing on the biological response of polyphenols in nutritional studies.",2020,The number of differentially modulated genes was higher with the puree (246) than with the unprocessed apple (182).,['minipigs challenged with a high fat meal'],"['apple matrix', 'high fat meal (HFM) supplemented with raw fruit, puree, or apple phenolic extract']","['total flavan-3-ol concentration', 'postprandial bioavailability of flavan-3-ols and nutrigenomic response', 'postprandial serum concentration of flavon-3-ols', 'Fasting and postprandial blood samples', 'nutrigenomic response of PBMCs']","[{'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453268', 'cui_str': 'Fresh fruit'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0912567', 'cui_str': 'flavan-3-ol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C1956006', 'cui_str': 'Nutritional Genomics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0060440', 'cui_str': 'flavone'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",309.0,0.0226814,The number of differentially modulated genes was higher with the puree (246) than with the unprocessed apple (182).,"[{'ForeName': 'Laurent-Emmanuel', 'Initials': 'LE', 'LastName': 'Monfoulet', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buffière', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Istas', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College, London, UK.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dufour', 'Affiliation': ""INRAE, Université d'Avignon, UMR408, Sécurité et Qualité des Produits d'Origine Végétale (SQPOV), Avignon, 84000, France.""}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Le Bourvellec', 'Affiliation': ""INRAE, Université d'Avignon, UMR408, Sécurité et Qualité des Produits d'Origine Végétale (SQPOV), Avignon, 84000, France.""}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Mercier', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bayle', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Boby', 'Affiliation': 'INRAE, Unité Mixte de Recherches sur les Herbivores, Clermont-Ferrand, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Remond', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Borel', 'Affiliation': 'C2VN, INRAE, INSERM, Aix Marseille Université, F-13005, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Mateos', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College, London, UK.""}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Milenkovic', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Morand', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France. christine.morand@inrae.fr.'}]",Food & function,['10.1039/d0fo00346h'] 2598,32459945,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Peele', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}, {'ForeName': 'Diane P', 'Initials': 'DP', 'LastName': 'Holder', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}]",The New England journal of medicine,['10.1056/NEJMc2001920'] 2599,32459946,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Stevens', 'Affiliation': 'Milken Institute School of Public Health, Washington, DC mordecai@gwu.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2001920'] 2600,32459947,"Health Care Hotspotting - A Randomized, Controlled Trial. Reply.",,2020,,[],[],['Health Care'],[],[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.196298,,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA afink@mit.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taubman', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA.'}]",The New England journal of medicine,['10.1056/NEJMc2001920'] 2601,32460220,Ultrasound imaging evaluation of structural and textural features in asymptomatic achilles tendons in pre-professional dancers: A cross-sectional study.,"OBJECTIVE To evaluate performance descriptors, sociodemographics variables and tendon echogenicity of asymptomatic Achilles tendons and to compare the echotexture from different classification subgroups. DESIGN A prospective, randomized cross-sectional study was carried out. SETTING laboratory of university. PARTICIPANTS Forty-two Achilles tendons (AT) were recruited from pre-professional dancers. Based on the echogenicity pattern, the sample was divided into two groups (n = 21, Heterogeneous group; n = 21, Homogeneous group). MAIN OUTOCOME MEASURES Ultrasound images and ImageJ measurements were performed to evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test were measured as performance parameter. RESULTS EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups. AT-TH, endurance test, balance test, years of dance, training hours per week and average pointe hours per week did not showed differences between groups. A multivariate prediction model between groups and the echotexture variables (EI (R 2  = 0.569; EV (R 2  = 0.341)) were determined. CONCLUSION Asymptomatic AT of heterogeneous group showed a lower EI and a higher EV compared to homogeneous group. Tendon echogenicity did not interact with performance variables.",2020,"RESULTS EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","['laboratory of university', 'Forty-two Achilles tendons (AT) were recruited from pre-professional dancers', 'asymptomatic achilles tendons in pre-professional dancers']",[],"['evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test', 'Tendon echogenicity']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",[],"[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",,0.0279145,"RESULTS EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: bcruz@us.es.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Barrera-García-Martín', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: irebargar@gmail.com.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Almazán-Polo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: jaime.almazan@universidadeuropea.es.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Jaén-Crespo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: gjaencrespo@gmail.com.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: carlos.romero@universidadeuropea.es.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.05.008'] 2602,32466588,"Effect of Neuromuscular Electrical Stimulation on Masseter Muscle Thickness and Maximal Bite Force Among Healthy Community-Dwelling Persons Aged 65 Years and Older: A Randomized, Double Blind, Placebo-Controlled Study.","AIM This study investigated the effect of neuromuscular electrical stimulation (NMES) on masseter muscle thickness and maximal bite force among healthy community-dwelling elderly persons older than 65 years. MATERIALS AND METHODS A total of 40 participants were randomly assigned to the experimental and placebo groups. In the experimental group, NMES was applied to both masseter muscles, and electrical signals were gradually increased until the participants felt a grabbing sensation (range 6.0-7.5 mA) in the masseter muscle. The placebo group, in contrast, underwent NMES in the same manner and procedure as the experimental group with less electrical intensity (0.5 mA). All interventions were administered five times a week for six weeks, 20 min per day. The outcomes were masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter. The level of significance was set as p < 0.05. RESULTS The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively). Moreover, the degree of change in the masseter muscle thickness and maximal bite force significantly increased in the experimental and placebo groups (p < 0.001, both). CONCLUSIONS This study demonstrated that NMES could be an effective modality for increasing masseter muscle thickness and maximal bite force in healthy older adults.",2020,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","['A total of 40 participants', 'healthy community-dwelling elderly persons older than 65 years', 'Aged 65 Years and Older', 'Healthy Community-Dwelling Persons', 'healthy older adults']","['Placebo', 'NMES', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular Electrical Stimulation', 'placebo']","['electrical intensity', 'Masseter Muscle Thickness and Maximal Bite Force', 'masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter', 'masseter muscle thickness and maximal bite force']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]",40.0,0.200011,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","[{'ForeName': 'Moon-Young', 'Initials': 'MY', 'LastName': 'Chang', 'Affiliation': 'Department of Occupational Therapy, Inje University, Gimhae 50834, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science, Health Sciences Division, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17113783'] 2603,32473275,Exploring the Effects of an Acute Dose of Antipsychotic Medication on Motivation-mediated BOLD Activity Using fMRI and a Perceptual Decision-making Task.,"The left inferior frontal gyrus and the bilateral ventral striatum are thought to be involved in motivation-mediated decision-making. Antipsychotics may influence this relationship, and atypical antipsychotics improve secondary negative symptoms in schizophrenia, such as loss of motivation, although the acute effects of pharmacological medication on motivation are not fully understood. In this single-blinded, randomized controlled trial, 49 healthy volunteers were randomized into three groups to receive a single dose of haloperidol, aripiprazole or placebo. Between 4.0 and 5.6 h later, participant's brain blood-oxygen-level dependent (BOLD) activity was recorded using functional magnetic resonance imaging (fMRI) while completing a perceptual decision-making fMRI task consisting of one neutral and one motivated condition. Response bias, reflecting the participant's willingness to say that the target stimulus is present, was calculated using signal detection theory. Concurrent with widespread changes in BOLD signal in the motivated vs. neutral condition, a less conservative, mathematically optimal response bias was observed in the motivated condition across the whole sample. Within-group differences in BOLD signal in the left inferior frontal gyrus and bilateral ventral striatum were observed between conditions in the aripiprazole and haloperidol groups, but not in the placebo group. No robust between-group differences in brain activity in the left inferior frontal gyrus or the bilateral ventral striatum were found. Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior. An interesting pattern of correlations possibly related to pharmacologically induced alterations in the dopamine system was observed, although findings remain inconclusive and must be replicated in larger samples.",2020,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.",['49 healthy volunteers'],"['haloperidol, aripiprazole or placebo', 'haloperidol', 'Antipsychotics', 'aripiprazole', 'antipsychotic medication', 'placebo']","['BOLD signal', 'brain blood-oxygen-level dependent (BOLD) activity', 'brain activity', 'bilateral ventral striatum']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",49.0,0.0560753,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Delfin', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Ethics, Law and Mental Health, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Sweden; Research Department, Regional Forensic Psychiatric Clinic Växjö, Sweden. Electronic address: carl.delfin@gu.se.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Reckless', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Bolstad', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Computational Radiology & Artificial Intelligence, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}]",Neuroscience,['10.1016/j.neuroscience.2020.05.035'] 2604,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR. MATERIALS AND METHODS Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices. RESULTS A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01). CONCLUSIONS The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110'] 2605,32453288,A Randomized Internet-Based Pilot Feasibility and Planning Study of Cherry Extract and Diet Modification in Gout.,"OBJECTIVE The aim of this study was to conduct a 9-month pilot Internet randomized controlled trial (RCT) of cherry extract and diet modification in gout to assess the feasibility of an Internet study and obtain effect estimates. METHODS After providing online informed consent in response to Internet advertisements and social media or clinic flyers, 84 people with physician-confirmed gout were randomized to either cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via Internet and phone calls. The primary objective was the feasibility of an Internet study, and secondary objectives were to obtain effect estimates for gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs) for future trials. RESULTS Of the 84 people randomized, overall completion rates were more than 80% for most study procedures up to 6 months and similar for the 2 active comparators. Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively. Any AEs and gastrointestinal symptoms/AEs at 9 months in cherry extract and diet modification groups were 3% versus 0% and 28% versus 27%, respectively. CONCLUSIONS An Internet gout RCT is feasible for nonpharmacological gout treatments. A hypothesis-testing, large Internet RCT of cherry extract versus placebo is needed.",2020,"Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively.","['Gout', '84 people randomized', '84 people with physician-confirmed gout']","['RCT', 'cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification', 'cherry extract and diet modification', 'Cherry Extract and Diet Modification', 'placebo']","['gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs', 'overall completion rates', 'gout flares and HAQ scores']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2960025', 'cui_str': 'Health assessment questionnaire score'}]",84.0,0.143097,"Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively.","[{'ForeName': 'Jasvinder A', 'Initials': 'JA', 'LastName': 'Singh', 'Affiliation': 'From the Medicine Service, VA Medical Center, Birmingham, AL.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Willig', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine at School of Medicine.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Darnell', 'Affiliation': 'Department of Nutrition.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Division of Clinical Immunology and Rheumatology.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Viocare, Princeton, NJ.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'Department of Epidemiology, School of Public Health.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001004'] 2606,32453876,"Metabolomics Reveals Altered Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids Associated with Marginal Vitamin A Deficiency in a Mongolian Gerbil Model.","SCOPE This study is designed to provide a broad evaluation of the impacts of vitamin A (VA) deficiency on hepatic metabolism in a gerbil model. METHODS AND RESULTS After 28 days of VA depletion, male Mongolian gerbils (Meriones unguiculatus) are randomly assigned to experimental diets for 28 days. Groups are fed a white-maize-based diet with ≈50 µL cottonseed oil vehicle either alone (VA-, n = 10) or containing 40 µg retinyl acetate (VA+, n = 10) for 28 days. Liver retinol is measured by high-performance liquid chromatography. Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides, and endocannabinoids are analyzed in post-mortem liver samples by liquid chromatography-mass spectrometry. RESULTS Liver retinol is lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency. A total of 300 metabolites are identified. Marginal VA deficiency is associated with lower bile acids, trimethylamine N-oxide, and a variety of acylcarnitines, phospholipids and sphingomyelins (p < 0.05). Components of DNA, including deoxyguanosine, cytidine, and N-carbomoyl-beta-alanine (p < 0.05), are differentially altered. CONCLUSIONS Hepatic metabolomics in a marginally VA-deficient gerbil model revealed alterations in markers of the gut microbiome, fatty acid and nucleotide metabolism, and cellular structure and signaling.",2020,"RESULTS Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.",['male Mongolian gerbils (Meriones unguiculatus'],"['white maize-based diet with ∼50\xa0μL cottonseed oil vehicle either alone (VA-, n\xa0=\xa010) or containing 40\xa0μg retinyl acetate (VA+, n\xa0=\xa010) for 28 d. Liver retinol was measured by high-performance liquid chromatography (HPLC', 'vitamin A (VA) deficiency']","['Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides and endocannabinoids', 'Liver retinol', 'Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0324939', 'cui_str': 'Meriones unguiculatus'}, {'cui': 'C0022392', 'cui_str': 'Meriones'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073109', 'cui_str': 'Retinol acetate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008562', 'cui_str': 'High pressure liquid chromatography'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025249', 'cui_str': 'Membrane lipid'}]",300.0,0.057129,"RESULTS Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'La Frano', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Brito', 'Affiliation': 'Laboratory of Pharmacokinetics and Metabolomic Analysis, Institute of Translational Medicine and Biotechnology, I. M. Sechenov First Moscow State Medical University, Moscow, 119991, Russia.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Baylee', 'Initials': 'B', 'LastName': 'Wilhelmson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Gannon', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'Rob K', 'Initials': 'RK', 'LastName': 'Fanter', 'Affiliation': 'College of Agriculture, Food and Environmental Sciences, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Pedersen', 'Affiliation': 'Department of Food Science and Technology, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Tanumihardjo', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'West Coast Metabolomics Center, University of California, Davis, CA, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901319'] 2607,32454356,Benefit-cost analysis of Promoting First Relationships®: Implications of victim benefits assumptions for return on investment.,"BACKGROUND Child abuse and neglect (CAN) cost United States society $136 billion to $428 billion annually. Preventive interventions that reduce CAN may improve people's lives and generate economic benefits to society, but their magnitude is likely to vary greatly with assumptions about victim costs avoided through intervention. OBJECTIVE We examined the implications of different assumptions about avoided victim costs in a benefit-cost analysis of Promoting First Relationships® (PFR), a 10-session attachment and strengths-based home visiting intervention. PARTICIPANTS AND SETTING Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123). METHODS We monetized intervention effects on out-of-home placements and implicit effects on CAN and calculated net present values under three scenarios: (1) benefits from avoided system costs, (2) additional benefits from avoided tangible victim costs, and (3) additional benefits from avoided tangible and intangible quality-of-life victim costs. For scenarios 2 and 3, we varied the CAN effect size and estimated the effect size at which PFR was reliably cost beneficial. RESULTS PFR's societal net benefit ranged from $1 (scenario 1) to $5514 - $25,562 (scenario 2) and $7004 - $32,072 (scenario 3) (2014 USD). In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25. CONCLUSIONS PFR is cost beneficial assuming tangible victim costs are avoided by PFR. Research into the long-term health and economic consequences of reducing CAN in at-risk populations would contribute to comprehensive, accurate benefits models.",2020,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25. ",['Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123'],['Promoting First Relationships®'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}]",[],,0.0284117,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25. ","[{'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Kuklinski', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Ave. NE, Suite 401, Seattle, WA 98115, United States. Electronic address: mrk63@uw.edu.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Oxford', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mloxford@uw.edu.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Spieker', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: spieker@uw.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Lohr', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mjlohr@uw.edu.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'Center for The Study of Health and Risk Behavior, Department of Psychiatry, University of Washington, United States. Electronic address: cnbflem@uw.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104515'] 2608,32457366,Efficacy of water spray for evaporative cooling in athletes with spinal cord injury.,"STUDY DESIGN Interventional crossover study. OBJECTIVE Spinal cord injury (SCI) disrupts afferent input to the hypothalamus and impairs efferent vaso- and sudomotor output, especially in lesions above the sympathetic chain (T1-L2). In consequence, persons with SCI under heat stress experience impairment in the ability to dissipate heat proportional to the lesion level. Thermoregulatory dysfunction places an individual at high risk of hyperthermia, which can be life threatening, especially for athletes with SCI during exercise. Current evidence on therapeutic cooling techniques in athletes with SCI is limited, but basic physiologic and research data suggest water spray (WS) might be efficacious, particularly in athletes with tetraplegia (TP), who are most impaired in thermoregulation. The aim of this study was to evaluate the effect of WS on core temperature (Tc) during exercise in athletes with SCI. SETTING Texas, USA. METHODS Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a wheelchair intermittent sprint exercise for 90 min under two conditions: (1) WS application every 15 min and (2) control (C), without WS. Tc was measured every 15 min and was analyzed for the effect of group (TP, PP, and AB) and time. Change in Tc (ΔTc) was also compared between groups. RESULTS ΔTc was significantly higher in TP vs. PP (p < 0.0001) and TP vs. AB (p < 0.0001) groups under C treatment. WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB. CONCLUSION WS effectively attenuated Tc elevation during exercise in athletes with TP. SPONSORSHIP Texas chapter of the Paralyzed Veterans of America.",2019,"WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB. CONCLUSION WS effectively attenuated Tc elevation during exercise in athletes with TP. ","['Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a', 'athletes with tetraplegia (TP', 'SPONSORSHIP\n\n\nTexas chapter of the Paralyzed Veterans of America', 'athletes with spinal cord injury', 'athletes with SCI.\nSETTING\n\n\nTexas, USA', 'athletes with SCI']","['wheelchair intermittent sprint exercise for 90\u2009min under two conditions: (1) WS application every 15\u2009min and (2) control (C), without WS', 'water spray']","['core temperature (Tc', 'TP vs. PP', 'Change in Tc (ΔTc', 'Tc elevation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",11.0,0.0318801,"WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB. CONCLUSION WS effectively attenuated Tc elevation during exercise in athletes with TP. ","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trbovich', 'Affiliation': 'Department of Rehabilitation Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. trbovichm@uthscsa.edu.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Koek', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': 'School of Health Professions, Physical Therapy Department, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0194-8'] 2609,32458393,Correction to: Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial.,"The original version of this article, unfortunately, contained an error. The given names and family names of the authors were interchanged and are now presented correctly. The original article has been corrected.].",2020,"The original version of this article, unfortunately, contained an error.",['pilonidal disease'],['Conservative Sinusectomy vs. excision and primary off-midline closure'],[],"[{'cui': 'C2317114', 'cui_str': 'Pilonidal disease'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.0503036,"The original version of this article, unfortunately, contained an error.","[{'ForeName': 'Sotirios Georgios', 'Initials': 'SG', 'LastName': 'Popeskou', 'Affiliation': 'Department of Visceral Surgery and Transplantation, Geneva University Hospitals, Geneva, Switzerland. salvator10@yahoo.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pravini', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Panteleimonitis', 'Affiliation': 'School of Health Sciences and social work, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Antoniacopo', 'Initials': 'A', 'LastName': 'Ferrario di Tor Vajana', 'Affiliation': 'Department of Surgery, Regional Hospital of Bellinzona, Bellinzona, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vanoni', 'Affiliation': 'Department of Visceral Surgery, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Schmalzbauer', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Posabella', 'Affiliation': 'Department of Surgery, Standort Unispital Clarunis, Universitäres Bauchzentrum Basel, Basel, Switzerland.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Christoforidis', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland. dimitri.christoforidis@eoc.ch.'}]",International journal of colorectal disease,['10.1007/s00384-020-03620-z'] 2610,32462829,Addition of Amlodipine or Valsartan for Improvement of Diastolic Dysfunction Associated with Hypertension.,"BACKGROUND Hypertensive patients are at increased risk of diastolic dysfunction. The hypothesis of this study was that addition of amlodipine would be superior to valsartan in improving diastolic dysfunction associated with hypertension. METHODS In this randomized trial, we randomly assigned 104 controlled, hypertensive patients with diastolic dysfunction to receive either amlodipine 2.5 mg or valsartan 40 mg, in addition to antihypertensive therapy. The primary end point was the change in the ratio of early mitral inflow velocity to early mitral annular relaxation velocity (E/E') from baseline to the 6-month follow-up. Secondary end points included changes in systolic blood pressure (SBP), left ventricular (LV) mass index, and left atrial volume index. RESULTS SBP decreased significantly from baseline in both treatment groups (p < 0.001). E/E' decreased significantly from 13.0 ± 2.2 to 12.0 ± 2.7 in the amlodipine arm and from 14.4 ± 4.3 to 12.7 ± 3.7 in the valsartan arm (p < 0.01 in both groups). The change of E/E' was not significantly different between treatment groups (p = 0.25). There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index. Two patients (3.8%) in the amlodipine group and 1 (16%) in the valsartan group had serious adverse event. CONCLUSIONS In this randomized trial involving controlled hypertensive patients, addition of amlodipine or valsartan was associated with an improvement of diastolic dysfunction, but the effects on diastolic dysfunction did not differ significantly between the treatment groups.",2020,"There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index.","['hypertensive patients with diastolic dysfunction to receive either', 'controlled hypertensive patients', 'Hypertensive patients']","['valsartan', 'amlodipine', 'Amlodipine or Valsartan', 'amlodipine or valsartan', 'amlodipine 2.5 mg or valsartan 40 mg, in addition to antihypertensive therapy']","['diastolic dysfunction', 'SBP, LV mass index, and left atrial volume index', 'Diastolic Dysfunction', 'systolic blood pressure (SBP), left ventricular (LV) mass index, and left atrial volume index', 'serious adverse event', 'risk of diastolic dysfunction', 'change in the ratio of early mitral inflow velocity to early mitral annular relaxation velocity (E/E', 'E/E', 'SBP', 'change of E/E']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1124795', 'cui_str': 'Amlodipine 2.5 MG'}, {'cui': 'C1132897', 'cui_str': 'valsartan 40 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",104.0,0.0345762,"There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index.","[{'ForeName': 'Jin Kyung', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Jeong Sook', 'Initials': 'JS', 'LastName': 'Seo', 'Affiliation': 'Division of Cardiology, Inje University Busan Paik Hospital, Busan, Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Jae Hyeong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Sahmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Dae Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Jong Min', 'Initials': 'JM', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Duk Hyun', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea. dhkang@amc.seoul.kr.'}]",Journal of cardiovascular imaging,['10.4250/jcvi.2020.0005'] 2611,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome. METHODS Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention. RESULTS Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself. LIMITATIONS The mean level of procrastination in this study was lower than in other treatment studies of procrastination. CONCLUSIONS Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579'] 2612,32460116,The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial.,"OBJECTIVES Today all pregnant women are recommended to participate in moderate intensity aerobic and resistance-based physical activity/exercise ≥150 min/week. However, there are still controversies and scant knowledge on the role of regular exercise on delivery outcomes, including mode of delivery and length of active labour. In addition, nutritional counselling have often been examined together with exercise, which may independently effect the outcomes. Hence, the aims of the present study were to investigate the sole effect of supervised group exercise, including pelvic floor muscle training on course of labour and mode of delivery. STUDY DESIGN A single blind, randomized controlled trial, performed in the municipality of Oslo, Norway. Out of 105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7 ± 4.2) to study the effect regular aerobic exercise (60 min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7 ± 1.7) on labour outcomes (exercise: 43 and control: 47). Data were collected via standardized interviews and birth partographs from hospital records, reported on the postpartum visit (weeks after labour 7.6 ± 1.6). The primary investigator was unaware of the original randomization at the time of the interviews. The principal analysis was done on an intention to treat basis (ITT). For the planned subgroup analyses (per protocol), acceptable intervention adherence was defined as attending ≥ 80% of the recommended exercise program (≥ 19 exercise sessions). RESULTS There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT. Per protocol analyses, showed a shorter duration of total active labour in the exercise group (6.8 ± 5.5 h) than the control group (9.8 ± 5.4 h), with a mean between group difference of 3.1 h (95% CI 0.31-5.9, p = 0.029). Rate of normal vaginal delivery was 85.7% among adherent participants and 62.3% in the control group (p = 0.051). CONCLUSIONS Regular exercise during pregnancy decreased duration of total active labour and showed a trend towards more normal vaginal deliveries among participants who adhered to the prescribed program. TRIAL REGISTRATION ClinicalTrials.gov: NCT00617149.",2020,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","['60\u2009min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7\u2009±\u20091.7) on labour outcomes (exercise: 43 and control: 47', 'Today all pregnant women', '105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7\u2009±\u20094.2) to study the effect', 'municipality of Oslo, Norway']","['regular exercise training', 'Regular exercise', 'regular aerobic exercise', 'supervised group exercise, including pelvic floor muscle training']","['normal vaginal deliveries', 'duration of total active labour', 'shorter duration of total active labour', 'Rate of normal vaginal delivery', 'induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT', 'acceptable intervention adherence']","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",105.0,0.114603,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Associate Professor, Exercise Scientist, Norwegian School of Sports Sciences, Department of Sports Medicine, PO Box 4014, Ullevål Stadion, Oslo, Norway. Electronic address: lahaakstad@nih.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Professor, Exercise Scientist, Physical Therapist, Norwegian School of Sports Sciences, Department of Sports Medicine, Norway. Electronic address: kari.bo@nih.no.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.014'] 2613,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary. OBJECTIVE To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning. METHODS A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied. RESULTS Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months. CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929'] 2614,32460989,"Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study.","BACKGROUND Sodium hyaluronate has been proposed as a treatment for improving the symptoms of chronic rhinosinusitis. The present study evaluated the effect of the intranasal administration of hyaluronic acid in a group of patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP). MATERIALS AND METHODS Thirty subjects aged 18-65 years affected by CRSsNP were enrolled. The subjects were randomly administered hyaluronic acid or isotonic saline solution by nasal nebulizer twice per day for 30 days. They were evaluated before (T0) and after the treatment (T1) with Sino-Nasal Outcome Test-22, visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology. RESULTS Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters. Being included in the study group rather than in the control group did not have a significant effect on the variation of the considered parameters between T0 and T1. Considering the effects of the micronized douches independently from the type of solution used (either hyaluronic acid or isotonic saline solution), although no difference emerged between study and control group for any of the objective parameters, there was an improvement of Sino-Nasal Outcome Test-22 scores (p = .0005), visual analogue scale for nasal obstruction (p = .0006) and for hyposmia/hypogeusia (p = .04). CONCLUSIONS The treatment with micronized nasal douches can improve the sino-nasal symptoms of CRSsNP, in particular nasal obstruction and olfactory ability. No advantage of the use of hyaluronic acid over isotonic saline solution emerged.",2020,"Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters.","['Thirty subjects aged 18-65\xa0years affected by CRSsNP were enrolled', 'non-polipoid chronic rhinosinusitis', 'patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP']","['micronized nasal irrigations with hyaluronic acid/isotonic saline solution', 'hyaluronic acid', 'hyaluronic acid or isotonic saline solution']","['Sino-Nasal Outcome Test-22 scores', 'visual analogue scale for nasal obstruction', 'objective and subjective parameters', 'sino-nasal symptoms of CRSsNP', 'visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0151934', 'cui_str': 'Hypogeusia'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0430616', 'cui_str': 'Active anterior rhinomanometry'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}]",30.0,0.0947609,"Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters.","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Savietto', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Marioni', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Maculan', 'Affiliation': 'Department of Cardiac Thoracic and Vascular Sciences and Public Health, Hygiene and Public Health Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pettorelli', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scarpa', 'Affiliation': 'Department of Statistical Sciences, University of Padova, Padova, Italy; Department of Mathematics ""Tullio Levi-Civita"", University of Padova, Padova, Italy.'}, {'ForeName': 'Edi', 'Initials': 'E', 'LastName': 'Simoni', 'Affiliation': 'Department of Neuroscience, Bioacoustics Research Laboratory, University of Padova, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Astolfi', 'Affiliation': 'Department of Neuroscience, Bioacoustics Research Laboratory, University of Padova, Padova, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Marchese-Ragona', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Ottaviano', 'Affiliation': 'Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy. Electronic address: giancarlo.ottaviano@unipd.it.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102502'] 2615,32466396,Does Post-Activation Performance Enhancement Occur During the Bench Press Exercise under Blood Flow Restriction?,"Background : The aim of the present study was to evaluate the effects of post-activation performance enhancement (PAPE) during successive sets of the bench press (BP) exercise under blood flow restriction (BFR). Methods : The study included 10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg). The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction. During the experimental sessions, the study participants performed 3 sets of 3 repetitions of the BP exercise at 70%1RM with a 5 min rest interval between sets. The differences in peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions were examined using 2-way (condition × set) repeated measures ANOVA. Furthermore, t-test comparisons between conditions were made for the set 2-set 1, set 3-set 1, and set 3-set 2 delta values for all variables. Results : The post hoc results for condition × set interaction in PP showed a significant increase in set 2 compared to set 1 for BFR ( p < 0.01) and CONT ( p = 0.01) conditions, a significant increase in set 3 compared to set 1 for the CONT ( p = 0.01) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition occurred ( p < 0.01). The post hoc results for condition × set interaction in PV showed a significant increase in set 2 compared to set 1 for BFR ( p < 0.01) and CONT ( p = 0.01) conditions, a significant increase in set 3 compared to set 1 for CONT ( p = 0.03) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition ( p < 0.01). The t-test comparisons showed significant differences in PP ( p < 0.01) and PV ( p = 0.01) for set 3-set 2 delta values between BFR and CONT conditions. Conclusion : The PAPE effect was analyzed through changes in power output and bar velocity that occurred under both the CONT and BFR conditions. However, the effects of PAPE have different kinetics in successive sets for BFR and for CONT conditions.",2020,The t-test comparisons showed significant differences in PP ( p < 0.01) and PV ( p = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,['10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg'],"['exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction', 'PAPE', 'post-activation performance enhancement (PAPE', 'BP exercise']","['peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions', 'PP', 'BFR condition', 'blood flow restriction (BFR', 'power output and bar velocity']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",10.0,0.0189799,The t-test comparisons showed significant differences in PP ( p < 0.01) and PV ( p = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szkudlarek', 'Affiliation': 'Department of Physical Pharmacy, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lockie', 'Affiliation': 'Center for Sports Performance, Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17113752'] 2616,32580914,Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal: A Proof of Concept Study.,"BACKGROUND Hypersexuality and hyposexuality occur frequently, often in a variety of psychiatric disorders, and are difficult to treat. While there is meta-analytic evidence for the significant effect of non-invasive brain stimulation on drug and food craving, no study has investigated the potential of this technique to modulate sexual behavior. AIM Here, we tested the hypothesis that a single session of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) would reduce sexual arousal. METHODS We employed a randomized, double-blind, sham-controlled crossover study design. 19 healthy male participants received high-frequency rTMS over the left DLPFC, high-frequency rTMS over the right DLPFC, and sham rTMS (each 10 Hz; 110% resting motor threshold; 60 trains with 50 pulses) in randomized and counterbalanced order with a 1-week interval between stimulation sessions to avoid carryover effects. Participants were exposed to neutral and sexual cues before and after each intervention and rated their sexual arousal after each block of cue presentation. MAIN OUTCOME MEASURE Efficacy of the respective intervention was operationalized by the change of subjective sexual arousal according to a rating scale. RESULTS rTMS of the right DLPFC significantly reduced subjective sexual arousal (t 18  = 2.282, P = .035). In contrast, neither sham rTMS nor rTMS of the left DLPFC affected sexual arousal (P > .389). Greater rTMS-induced reduction of subjective sexual arousal was observed in participants with higher trait-based dyadic sexual desire within the last 12 months (r = -0.417, P = .038). CLINICAL IMPLICATION Non-invasive brain stimulation might hold potential for influencing hypersexual behavior. STRENGTH & LIMITATION This was a randomized, double-blind, sham-controlled crossover study with subjective but no physiological measures of sexual arousal. CONCLUSION The results indicate that 1 session of high-frequency rTMS (10 Hz) of the right DLPFC could significantly reduce subjective sexual arousal induced by visual stimuli in healthy subjects. On this basis, future studies with larger sample sizes and more stimulation sessions are needed to explore the therapeutic potential of rTMS in hypersexual behavior. Schecklmann M, Sakreida K, Oblinger B, et al. Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal: A Roof of Concept Study. J Sex Med 2020;XX:XXX-XXX.",2020,"Greater rTMS-induced reduction of subjective sexual arousal was observed in participants with higher trait-based dyadic sexual desire within the last 12 months (r = -0.417, P = .038). ","['19 healthy male participants received', 'healthy subjects']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', 'high-frequency rTMS over the left DLPFC, high-frequency rTMS over the right DLPFC, and sham rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['Schecklmann M, Sakreida K, Oblinger B, et', 'subjective sexual arousal', 'Sexual Arousal', 'sexual arousal', 'dyadic sexual desire']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation'}, {'cui': 'C0023618', 'cui_str': 'Libido'}]",19.0,0.181717,"Greater rTMS-induced reduction of subjective sexual arousal was observed in participants with higher trait-based dyadic sexual desire within the last 12 months (r = -0.417, P = .038). ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Sakreida', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Oblinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Timm B', 'Initials': 'TB', 'LastName': 'Poeppl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen University, Aachen, Germany. Electronic address: timm.poeppl@rwth-aachen.de.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.05.002'] 2617,32468892,Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis.,"OBJECTIVE SB4, SB2, and SB5 are biosimilars of etanercept (ETN), infliximab (INF), and adalimumab (ADA), respectively. This pooled analysis evaluated the immunogenicity of these treatments across three phase III randomized controlled trials of patients with rheumatoid arthritis (RA). METHODS Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study). The effect of ADAbs on American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs) were evaluated. RESULTS The study included 1709 patients. The cumulative incidences of ADAbs were 30.3% in the all-treatments-combined group, 29.1% in the biosimilars combined group, and 31.5% in the reference products combined group. ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups. ADAb-positive patients also had a higher likelihood of developing ISRs/IRRs in the all-treatments-combined group [0.56 (0.31, 1.01), p = 0.0550], predominantly due to the results observed with SB2 + INF combined rather than with SB4 + ETN or SB5 + ADA combined. CONCLUSION In this pooled analysis, ADAbs were associated with reduced efficacy in patients with RA treated with biosimilars (SB4, SB2, and SB5) or their reference products (ETN, INF, and ADA). ADAbs were associated with an increased incidence of ISRs/IRRs in those treated with SB2 + INF. Clinical trial registration numbers: NCT01936181 (SB2 study), NCT01895309 (SB4 study), and NCT02167139 (SB5 study).",2020,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","['patients with rheumatoid arthritis (RA', 'Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study', '1709 patients', 'rheumatoid arthritis']","['tumour necrosis factor inhibitors', 'ADAbs']","['American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs', 'efficacy and tolerability', 'incidence of ISRs/IRRs', 'likelihood of developing ISRs/IRRs', 'cumulative incidences of ADAbs', 'ACR20 response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",1709.0,0.148957,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital , Leeds, UK.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Suh', 'Affiliation': 'Department of Rheumatology, Ajou University School of Medicine , Suwon, Republic of Korea.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Weinblatt', 'Affiliation': ""Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Keystone', 'Affiliation': 'Division of Rheumatology, Mount Sinai Hospital, University of Toronto , Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University Medical Center, Stanford University School of Medicine , Palo Alto, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vencovsky', 'Affiliation': 'Department of Rheumatology, Institute of Rheumatology , Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kay', 'Affiliation': 'Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School , Worcester, MA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hong', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ghil', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1732458'] 2618,32580920,Clinical behavior of posterior fixed partial dentures with a biologically oriented preparation technique: A 5-year randomized controlled clinical trial.,"STATEMENT OF PROBLEM Evidence of the behavior of the periodontal tissues around anterior teeth restored with the biologically oriented preparation technique (BOPT) is available. However, outcomes of this technique in posterior teeth restored with fixed partial dentures (FPDs) are lacking. PURPOSE The purpose of this randomized controlled clinical trial was to evaluate the clinical, mechanical, and biological behavior of posterior 3-unit FPDs placed on teeth prepared with BOPT. MATERIAL AND METHODS Forty participants received a 3-unit zirconia FPD in the posterior region of the mandible or maxilla. Twenty FPDs were placed on teeth prepared with BOPT (study group) and 20 on teeth with a horizontal chamfer finishing line (control group). Follow-up examinations were performed 1, 3, and 5 years after treatment to evaluate periodontal responses around the prepared teeth by means of the following parameters: plaque index, gingival index, probing depth, and marginal stability (MS). Mechanical behavior was also assessed, as were any complications. RESULTS After the 5-year follow-up, 57.9% of the control group and 35% of the BOPT group presented a plaque index of 1. The gingival index was 1 in 68.4% of the control group and 30% of the BOPT group after the follow-up period. In the analysis of probing depth, 26.3% of teeth in the control group had pockets of more than 3 mm in depth, whereas the BOPT group had only 10%. Marginal stability appeared in 100% of the BOPT group, whereas only 10.5% of the control group exhibited gingival stability. Complications during the follow-up period were similar, 20% in the control group and 15% in the BOPT group. CONCLUSIONS Posterior FPDs prepared by using BOPT had a good clinical response over a 5-year follow-up, with a low gingival index, a small increase in pocket depth, and a 100% marginal stability of the surrounding tissues. High survival rates after 5 years indicated that the technique produced predictable outcomes.",2020,"Complications during the follow-up period were similar, 20% in the control group and 15% in the BOPT group. ","['Twenty FPDs were placed on teeth prepared with BOPT (study group) and 20 on teeth with a horizontal chamfer finishing line (control group', 'in the posterior region of the mandible or maxilla', 'Forty participants received a']","['Posterior FPDs', 'BOPT', 'posterior fixed partial dentures with a biologically oriented preparation technique', '3-unit zirconia FPD']","['Marginal stability', 'plaque index, gingival index, probing depth, and marginal stability (MS', 'gingival stability', 'Mechanical behavior', 'Complications', 'High survival rates', 'gingival index', 'plaque index']","[{'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",20.0,0.0844149,"Complications during the follow-up period were similar, 20% in the control group and 15% in the BOPT group. ","[{'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Agustín-Panadero', 'Affiliation': 'Adjunct Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Serra-Pastor', 'Affiliation': 'Associate Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Spain. Electronic address: blanca.serrapastor@gmail.com.'}, {'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Loi', 'Affiliation': 'Private practice, Cagliari, Italy.'}, {'ForeName': 'M Jesús', 'Initials': 'MJ', 'LastName': 'Suárez', 'Affiliation': 'Adjunct Professor, Department of Dental Prosthesis, Faculty of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Pelaez', 'Affiliation': 'Associate Professor, Department of Dental Prosthesis, Faculty of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Solá-Ruíz', 'Affiliation': 'Adjunct Professor, Department of Stomatology, Faculty of Medicine and Dentistry, Valencia University, Spain.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.03.031'] 2619,32472075,Two nights of recovery sleep restores hippocampal connectivity but not episodic memory after total sleep deprivation.,"Sleep deprivation significantly impairs a range of cognitive and brain function, particularly episodic memory and the underlying hippocampal function. However, it remains controversial whether one or two nights of recovery sleep following sleep deprivation fully restores brain and cognitive function. In this study, we used functional magnetic resonance imaging (fMRI) and examined the effects of two consecutive nights (20-hour time-in-bed) of recovery sleep on resting-state hippocampal connectivity and episodic memory deficits following one night of total sleep deprivation (TSD) in 39 healthy adults in a controlled in-laboratory protocol. TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity. Following TSD, two nights of recovery sleep restored hippocampal connectivity to baseline levels, but did not fully restore memory performance nor its associations with hippocampal connectivity. These findings suggest that more than two nights of recovery sleep are needed to fully restore memory function and hippocampal-memory associations after one night of total sleep loss.",2020,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.",['39 healthy adults in a controlled in-laboratory protocol'],"['two consecutive nights (20-hour time-in-bed) of recovery sleep', 'total sleep deprivation (TSD', 'TSD', 'functional magnetic resonance imaging (fMRI']","['hippocampal connectivity to multiple prefrontal and default mode network regions', 'Sleep deprivation', 'memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",39.0,0.0326211,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Fan Nils', 'Initials': 'FN', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Sihua', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Raine', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jieqiong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Meichen', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Junghoon J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular, Cellular, and Biomedical Sciences, CUNY School of Medicine, The City College of New York, New York, NY, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. hengyi@pennmedicine.upenn.edu.'}]",Scientific reports,['10.1038/s41598-020-65086-x'] 2620,32478400,"The depot GnRH agonist protocol improves the live birth rate per fresh embryo transfer cycle, but not the cumulative live birth rate in normal responders: a randomized controlled trial and molecular mechanism study.","STUDY QUESTION Do cumulative live birth rates (CLBRs) after one complete ART cycle differ between the three commonly used controlled ovarian stimulation (COS) protocols (GnRH antagonist, depot GnRHa (GnRH agonist) and long GnRHa) in normal responders undergoing IVF/ICSI? SUMMARY ANSWER There were similar CLBRs between the GnRH antagonist, depot GnRHa and long GnRHa protocols. WHAT IS KNOWN ALREADY There is no consensus on which COS protocol is the most optimal in women with normal ovarian response. The CLBR provides the final success rate after one complete ART cycle, including the fresh and all subsequent frozen-thawed embryo transfer (ET) cycles. We suggest that the CLBR measure would allow for better comparisons between the different treatment protocols. STUDY DESIGN, SIZE, DURATION A prospective controlled, randomized, open label trial was performed between May 2016 and May 2017. A total of 819 patients were allocated to the GnRH antagonist, depot GnRHa or long GnRHa protocol in a 1:1:1 ratio. The minimum follow-up time from the first IVF cycle was 2 years. To further investigate the potential effect of COS with the GnRH antagonist, depot GnRHa or long GnRHa protocol on endometrial receptivity, the expression of homeobox A10 (HOXA10), myeloid ecotropic viral integration site 1 (MEIS1) and leukemia inhibitory factor (LIF) endometrial receptivity markers was evaluated in endometrial tissue from patients treated with the different COS protocols. PARTICIPANTS/MATERIALS, SETTING, METHODS Infertile women with normal ovarian response (n = 819) undergoing IVF/ICSI treatment were randomized to the GnRH antagonist, depot GnRHa or long GnRHa protocol. Both IVF and ICSI cycles were included, and the sperm samples used were either fresh or frozen partner ejaculates or frozen donor ejaculates. The primary outcome was the live birth rate (LBR) per fresh ET cycle, and the CLBR after one complete ART cycle, until the birth of a first child (after 28 weeks) or until all frozen embryos were used, whichever occurred first. Pipelle endometrial biopsies from 34 female patients were obtained on Days 7-8 after oocyte retrieval or spontaneous ovulation in natural cycles, respectively, and HOXA10, MEIS1 and LIF mRNA and protein expression levels in the human endometrium was determined by quantitative real-time PCR and western blot, respectively. MAIN RESULTS AND THE ROLE OF CHANCE There were no significant differences in CLBRs between the GnRH antagonist, depot GnRHa or long GnRHa protocol (71.4 versus 75.5 versus 72.2%, respectively). However, there was a significantly higher LBR per fresh ET cycle in the depot GnRHa protocol than in the long GnRHa and GnRH antagonist protocols (62.6 versus 52.1% versus 45.6%, P < 0.05). Furthermore, HOXA10, MEIS1 and LIF mRNA and protein expression in endometrium all showed significantly higher in the depot GnRHa protocol than in the long GnRHa and GnRH antagonist protocols (P < 0.05). LIMITATIONS, REASONS FOR CAUTION A limitation of our study was that both our clinicians and patients were not blinded to the randomization for the randomized controlled trial (RCT). An inclusion criterion for the current retrospective cohort study was based on the 'actual ovarian response' during COS treatment, while the included population for the RCT was 'expected normal responders' based on maternal age and ovarian reserve test. In addition, the analysis was restricted to patients under 40 years of age undergoing their first IVF cycle. Furthermore, the endometrial tissue was collected from patients who cancelled the fresh ET, which may include some patients at risk for ovarian hyperstimulation syndrome, however only patients with 4-19 oocytes retrieved were included in the molecular study. WIDER IMPLICATIONS OF THE FINDINGS The depot GnRH agonist protocol improves the live birth rate per fresh ET cycle, but not the cumulative live birth rate in normal responders. A possible explanation for the improved LBR after fresh ET in the depot GnRHa protocol could be molecular signalling at the level of endometrial receptivity. STUDY FUNDING/COMPETING INTEREST(S) This project was funded by Grant 81571439 from the National Natural Sciences Foundation of China and Grant 2016YFC1000206-5 from the National Key Research & Development Program of China. The authors declare no conflict of interest. TRIAL REGISTRATION NUMBER The RCT trial was registered at the Chinese Clinical Trial Registry, Study Number: ChiCTR-INR-16008220. TRIAL REGISTRATION DATE 5 April 2016. DATE OF FIRST PATIENT’S ENROLLMENT 12 May 2016.",2020,"There were no significant differences in CLBRs between the GnRH antagonist, depot GnRHa or long GnRHa protocol (71.4 versus 75.5 versus 72.2%, respectively).","['endometrial tissue from patients treated with the different COS protocols', 'Infertile women with normal ovarian response (n\u2009=\u2009819) undergoing IVF/ICSI treatment', '819 patients', 'patients under 40\xa0years of age undergoing their first IVF cycle', '’S', 'women with normal ovarian response', '34 female patients', 'patients with 4-19 oocytes retrieved were included in the molecular study', 'normal responders undergoing IVF/ICSI']","['GnRH antagonist, depot GnRHa or long GnRHa protocol', 'controlled ovarian stimulation (COS) protocols (GnRH antagonist, depot GnRHa (GnRH agonist) and long GnRHa']","['endometrial receptivity, the expression of homeobox A10 (HOXA10), myeloid ecotropic viral integration site 1 (MEIS1) and leukemia inhibitory factor (LIF) endometrial receptivity markers', 'live birth rate per fresh embryo transfer cycle', 'CLBRs', 'live birth rate (LBR) per fresh ET cycle, and the CLBR after one complete ART cycle, until the birth of a first child', 'Furthermore, HOXA10, MEIS1 and LIF mRNA and protein expression in endometrium', 'LBR per fresh ET cycle', 'live birth rate per fresh ET cycle', 'HOXA10, MEIS1 and LIF mRNA and protein expression levels', 'cumulative live birth rate']","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4760174', 'cui_str': 'HOXA 10 Proteins'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0085224', 'cui_str': 'Integration, Virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0125606', 'cui_str': 'Cholinergic Differentiation Factor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",819.0,0.172986,"There were no significant differences in CLBRs between the GnRH antagonist, depot GnRHa or long GnRHa protocol (71.4 versus 75.5 versus 72.2%, respectively).","[{'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Geerts', 'Affiliation': 'Department of Medical Biology, Amsterdam University Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Shiqiao', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Guijin', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa086'] 2621,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978'] 2622,32473959,A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers.,"Few trial data are available concerning the impact of personalised cancer risk information on behaviour. This study assessed the short-term effects of providing personalised cancer risk information on cancer risk beliefs and self-reported behaviour. We randomised 1018 participants, recruited through the online platform Prolific, to either a control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice. The primary outcome was change from baseline in computed risk relative to an individual with a recommended lifestyle (RRI) 1 at three months. Secondary outcomes included: health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction. After three months there were no between-group differences in change in RRI (p = 0.71). At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group. The increases in accuracy and conviction were only seen in individuals with high numeracy and low baseline conviction, respectively. These findings suggest that personalised cancer risk information alongside lifestyle advice can increase short-term risk accuracy and conviction without increasing worry or anxiety but has little impact on health-related behaviour. Trial registration: ISRCTN17450583. Registered 30 January 2018.",2020,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","['1018 participants, recruited through the online platform Prolific, to either a']","['control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice', 'personalised cancer risk information', 'online risk information and lifestyle advice']","['computed risk relative to an individual with a recommended lifestyle (RRI', 'accuracy and conviction', 'health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction', 'accuracy of absolute risk perception', 'absolute and comparative risk conviction', 'change in RRI', 'intention to increase fruit and vegetables', 'cancer risk beliefs and self-reported behaviour']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1547273', 'cui_str': 'Preventable'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",1018.0,0.105156,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","[{'ForeName': 'Golnessa', 'Initials': 'G', 'LastName': 'Masson', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: gh453@medschl.cam.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: kmills@medschl.cam.ac.uk.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge CB2 0QQ, UK. Electronic address: stephen.sharp@mrc-epid.cam.ac.uk.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'National Cancer Institute, Rockville, MD, USA. Electronic address: kleinwm@mail.nih.gov.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: srs34@medschl.cam.ac.uk.'}, {'ForeName': 'Juliet A', 'Initials': 'JA', 'LastName': 'Usher-Smith', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: jau20@medschl.cam.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106154'] 2623,32475050,Impact of age on clinical outcomes of antihypertensive therapy in patients with hypertension and coronary artery disease: A sub-analysis of the Heart Institute of Japan Candesartan Randomized Trial for Evaluation in Coronary Artery Disease.,"This study aimed to determine whether different systolic blood pressure (SBP) measurements achieved with antihypertensive therapy impact clinical outcomes by age in patients with hypertension and coronary artery disease (CAD). This post hoc analysis from the Heart Institute of Japan Candesartan Randomized Trial for Evaluation in Coronary Heart Disease (HIJ-CREATE) trial included 2048 patients with hypertension and angiographically documented CAD. Participants were divided into three groups based on age at enrollment: middle-aged (<60 years, n = 570), pre-elderly (≥60-<70 years, n = 730), and elderly (≥70 years, n = 748). Among the 2,048 patients, 1695 (82.7%) underwent percutaneous coronary intervention. The primary end point was the time to first occurrence of a major adverse cardiac event (MACE). During a median follow-up of 4.2 years, the MACE rate was 19.8%, 28.1%, and 31.1% in the middle-aged, pre-elderly, and elderly groups, respectively. Achieved BP was defined as the mean BP during scheduled visits. Patients with higher achieved SBP had a higher occurrence of MACE in all age groups. An unadjusted quadratic proportional hazard model was used to evaluate the relationship between achieved BP during follow-up and risk for MACE. In each age group, participants were divided into quartiles based on the achieved BP during follow-up. The relationship between achieved SBP and the incidence of MACE did not follow a J-shaped curve in any age group. In conclusion, in the contemporary era of aggressive coronary revascularization, a lower SBP target may be appropriate even in elderly patients with hypertension and CAD.",2020,The relationship between achieved SBP and the incidence of MACE did not follow a J-shaped curve in any age group.,"['patients with hypertension and coronary artery disease (CAD', 'patients with hypertension and coronary artery disease', '2,048 patients, 1695 (82.7%) underwent', 'Participants were divided into three groups based on age at enrollment: middle-aged (<60\xa0years, n\xa0=\xa0570), pre-elderly (≥60-<70\xa0years, n\xa0=\xa0730), and elderly (≥70\xa0years, n\xa0=\xa0748', 'elderly patients with hypertension and CAD', '2048 patients with hypertension and angiographically documented CAD']","['antihypertensive therapy', 'percutaneous coronary intervention']","['time to first occurrence of a major adverse cardiac event (MACE', 'MACE rate', 'Achieved BP', 'mean BP', 'systolic blood pressure (SBP) measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",2048.0,0.0261546,The relationship between achieved SBP and the incidence of MACE did not follow a J-shaped curve in any age group.,"[{'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kikuchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Jujo', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13891'] 2624,32475085,The Weight Optimization Revamping Lifestyle using the Dietary Guidelines (WORLD) Study: Sustained Weight Loss Over 12 Months.,"OBJECTIVE This study aimed to compare two energy-restricted, nutrient-dense diets at the upper or lower ends of the dietary fat recommendation range (lower fat [20% energy from fat] versus moderate fat [35%]) on weight loss using behavioral theory-based nutrition education. METHODS A total of 101 premenopausal women with overweight or obesity were randomized to an energy-restricted lower-fat or moderate-fat diet for 1 year. Interventions included 28 behavioral theory-based nutrition education sessions plus weekly exercise sessions. RESULTS Both treatment groups experienced weight loss (-5.0 kg for lower fat and -4.3 kg for moderate fat; P < 0.0001), but there was no difference in weight loss or fat intake between groups. Total and low-density lipoprotein cholesterol decreased (-3. 4 mg/dL and -3.8 mg/dL; P < 0.05), and high-density lipoprotein cholesterol increased (1.9 mg/dL; P < 0.05) in both groups at 12 months. Diet quality, assessed by the Healthy Eating Index, increased significantly at 4 months versus baseline (70.8 [0.9] vs. 77.8 [1.0]) and was maintained through 12 months. Higher Healthy Eating Index scores were associated with greater weight loss at 4 months (r = -0.2; P < 0.05). CONCLUSIONS In the context of a well-resourced, free-living weight-loss intervention, total fat intake did not change; however, theory-based nutrition education underpinned by food-based recommendations resulted in caloric deficits, improvements in diet quality, and weight loss that was sustained for 1 year.",2020,"Higher Healthy Eating Index scores were associated with greater weight loss at 4 months (r = -0.2; P < 0.05). ",['101 premenopausal women with overweight or obesity'],"['28 behavioral theory-based nutrition education sessions plus weekly exercise sessions', 'energy-restricted lower-fat or moderate-fat diet for 1 year']","['Weight Loss', 'Diet quality', 'diet quality, and weight loss', 'high-density lipoprotein cholesterol', 'weight loss', 'Healthy Eating Index', 'weight loss or fat intake', 'Higher Healthy Eating Index scores', 'Total and low-density lipoprotein cholesterol']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301585', 'cui_str': 'Fat diet'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",101.0,0.0236992,"Higher Healthy Eating Index scores were associated with greater weight loss at 4 months (r = -0.2; P < 0.05). ","[{'ForeName': 'Tricia L', 'Initials': 'TL', 'LastName': 'Psota', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lohse', 'Affiliation': 'Wegmans School of Health and Nutrition, Rochester Institute of Technology, Rochester, New York, USA.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Miller', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22824'] 2625,32457012,Metoclopramide Reduces Fluoroscopy and Procedure Time during Gastrojejunostomy Tube Placement: A Placebo-Controlled Trial.,"PURPOSE To determine whether a single 10-mg intravenous dose of the promotility agent metoclopramide reduces the fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement. METHODS This prospective, randomized, double-blind, placebo-controlled trial enrolled consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019. Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy. Average fluoroscopy times, radiation doses, and procedure times were compared using t-tests. The full study protocol can be found at www.clinicaltrials.gov (NCT03331965). RESULTS Of 110 participants randomized 1:1, 45 received metoclopramide and 51 received placebo and underwent GJ tube placement (38 females and 58 males; mean age, 55 ± 18 years). Demographics of the metoclopramide and placebo groups were similar. The fluoroscopy time required to advance a guide wire through the pylorus averaged 1.6 minutes (range, 0.3-10.1 minutes) in the metoclopramide group versus 4.1 minutes (range, 0.2-27.3 minutes) in the placebo group (P = .002). Total procedure fluoroscopy time averaged 5.8 minutes (range, 1.5-16.2 minutes) for the metoclopramide group versus 8.8 minutes (range, 2.8-29.7 minutes) for the placebo group (P = .002). Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04). Total procedure time averaged 16.4 minutes (range, 8-51 minutes) for the metoclopramide group versus 19.9 minutes (range, 6-53 minutes) for the placebo group (P = .04). There were no drug-related adverse events and no significant differences in procedure-related complications. CONCLUSIONS A single dose of metoclopramide reduced fluoroscopy time by 34%, radiation dose by 30%, and procedure time by 17% during GJ tube placement.",2020,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","['consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019', '110 participants randomized 1:1, 45 received', 'Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy', '38 females and 58 males; mean age, 55 ± 18 years']","['metoclopramide and placebo', 'Placebo', 'Metoclopramide', 'metoclopramide', 'GJ tube placement', 'placebo']","['procedure-related complications', 'fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement', 'Total procedure time', 'Average fluoroscopy times, radiation doses, and procedure times', 'fluoroscopy time', 'Total procedure fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532670', 'cui_str': 'Obtaining consent'}, {'cui': 'C0570599', 'cui_str': 'Allergy to metoclopramide'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",110.0,0.369738,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DuRocher', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gazda', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Olivas', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Whited', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Langston', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Charles Y', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ronald', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710. Electronic address: james.ronald@duke.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.028'] 2626,32458450,"Effect of Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding on Gastrin, Motilin, Secretin, and Cholecystokinin Hormones in Preterm Infants: A Pilot Crossover Study.","BACKGROUND Oropharyngeal administration of milk prior to gavage feeding has been shown to improve feeding tolerance in preterm infants. OBJECTIVES The aim is to study the effect of oropharyngeal administration of mother's milk (OPAMM), prior to gavage feeding, on the levels of gastrin, motilin, secretin, and cholecystokinin hormones. METHODS Preterm infants (<32 weeks' gestation) were randomized at a corrected gestational age of 33-34 weeks, in a crossover design, to receive 1 of 2 protocols: 24 hours of OPAMM practice (applying 0.2 mL of mother's milk prior to each gavage feeding) followed by 24 hours of regular gavage-feeding practice in the first protocol or vice versa in the second protocol. The levels of gastrin, motilin, secretin, and cholecystokinin hormones were measured at the end of 24 hours of both practices. RESULTS The data of 40 preterm infants (20 in each protocol) were analyzed. OPAMM was associated with a significant increase in the levels of motilin (median, 233; interquartile range [IQR], 196-296 vs median, 196; IQR, 128-233; P < .01), secretin (median, 401; IQR, 353-458 vs median, 370; IQR, 331-407; P = .04), and cholecystokinin (median, 21.4; IQR, 16-27.1 vs median, 14.9; IQR, 11-20.5; P <.01) but not gastrin (median, 202; IQR, 125-238 vs median, 175; IQR, 128-227; P = .7), compared with regular gavage-feeding practice. CONCLUSION Oro-pharyngeal stimulation by OPAMM, prior to gavage feeding, significantly increased motilin hormone and possibly increased secretin and cholecystokinin hormones.",2020,"The levels of gastrin, motilin, secretin, and cholecystokinin hormones were measured at the end of 24 hours of both practices. ","['preterm infants', 'Preterm Infants', ""Mother's Milk"", '40 preterm infants (20 in each protocol', 'Preterm infants (< 32 weeks gestation']","[""Oro-Pharyngeal Administration of Mother's Milk (OPAMM"", ""OPAMM practice (applying 0.2 mL of mother's milk prior to each gavage feeding""]","['Gastrin, Motilin, Secretin, and Cholecystokinin Hormones', 'levels of gastrin, motilin, secretin, and cholecystokinin hormones', 'levels of motilin', 'OPAMM', 'motilin hormone', 'secretin and cholecystokinin hormones']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}]","[{'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0026594', 'cui_str': 'Motilin'}, {'cui': 'C0036534', 'cui_str': 'Secretin'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.0321978,"The levels of gastrin, motilin, secretin, and cholecystokinin hormones were measured at the end of 24 hours of both practices. ","[{'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Mohammed', 'Affiliation': ""Neonatal Intensive Care Unit, Mansora University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Eid', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Mansoura, Mansoura, Egypt.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Elzehery', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, University of Mansoura, Mansoura, Egypt.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Al-Harrass', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, University of Mansoura, Mansoura, Egypt.'}, {'ForeName': 'Basma', 'Initials': 'B', 'LastName': 'Shouman', 'Affiliation': ""Neonatal Intensive Care Unit, Mansora University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Nehad', 'Initials': 'N', 'LastName': 'Nasef', 'Affiliation': ""Neonatal Intensive Care Unit, Mansora University Children's Hospital, Mansoura, Egypt.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1935'] 2627,32580838,Programmed Intermittent Epidural Bolus at Different Intervals Combined with Patient-controlled Epidural Analgesia on Body Temperature during Labour Analgesia.,"Objective: To explore the effects of programmed intermittent epidural bolus (PIEB) combined with patient-controlled epidural analgesia (PCEA) at different intervals on body temperature and serum CRP, TNF-α, IL-6 levels in parturient women receiving analgesia. STUDY DESIGN Descriptive study. PLACE AND DURATION OF STUDY The First Affiliated Hospital of Shaoyang University, China, from September 2018 to February 2020. METHODOLOGY One hundred and seventy primiparous women, who had vaginal delivery and required labour analgesia, were randomly divided into Groups A and B (n=85 for each group). In both groups, PIEB plus PCEA mode was applied when cervical dilatation reached 2-3 cm. The interval was 30 minutes with a pulse dose of 5 mL in Group A; and 60 minutes with a pulse dose of 10 mL in Group B. Indicators related to body temperature and serum markers were compared in both the groups. RESULT Maternal temperature in Group A was higher than that in Group B at the time of cervix being completely dilated, and 2 hours after delivery (both p <0.001). incidence of intrapartum fever in Group A was higher than that in Group B (p = 0.036). Epidural analgesic dosage, VAS score, serum CRP, TNF-α, and IL-6 levels in Group A were higher than those in Group B at two hours after delivery (all p <0.001). CONCLUSIONS PIEB plus PCEA mode at regular intervals of 60 minutes can reduce epidural analgesic dosage and incidence of intrapartum fever during delivery, thus exerting better analgesic effects. Key Words:  Programmed intermittent epidural bolus (PIEB), Patient-controlled epidural analgesia (PCEA), Delivery, Analgesia, Parturient, Body temperature.",2020,incidence of intrapartum fever in Group A was higher than that in Group B (p = 0.036).,"['One hundred and seventy primiparous women, who had vaginal delivery and required labour analgesia', 'parturient women receiving analgesia', 'The First Affiliated Hospital of Shaoyang University, China, from September 2018 to February 2020']","['programmed intermittent epidural bolus (PIEB) combined with patient-controlled epidural analgesia (PCEA', 'Key Words: \xa0Programmed intermittent epidural bolus (PIEB), Patient-controlled epidural analgesia (PCEA), Delivery, Analgesia, Parturient, Body temperature']","['body temperature and serum CRP, TNF-α, IL-6 levels', 'epidural analgesic dosage and incidence of intrapartum fever', 'incidence of intrapartum fever', 'cervical dilatation', 'Epidural analgesic dosage, VAS score, serum CRP, TNF-α, and IL-6 levels']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",170.0,0.0235402,incidence of intrapartum fever in Group A was higher than that in Group B (p = 0.036).,"[{'ForeName': 'Beilei', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shaoyang University, Hunan Province, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Department of Obstetrics, The First Affiliated Hospital of Shaoyang University, Hunan Province, China.'}, {'ForeName': 'Aidi', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shaoyang University, Hunan Province, China.'}, {'ForeName': 'Dongyun', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shaoyang University, Hunan Province, China.'}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shaoyang University, Hunan Province, China.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.05.463'] 2628,32460396,Effects of photobiomodulation with low-level laser therapy in burning mouth syndrome: A randomized clinical trial.,"BACKGROUND Photobiomodulation (PBM) has proven to be effective in different painful conditions. OBJECTIVES To assess the effect of photobiomodulation for pain management in burning mouth syndrome (BMS) patients, besides analysing the impact on different aspects of quality of life. METHODS A randomized, single-blind, clinical trial was performed among 20 patients with BMS. Photobiomodulation was applied in the study group (n = 10) with a dose of 12 J/cm 2 during 10 sessions, comparing with a placebo group (n = 10) with the laser turned off. Pain was assessed using the visual analogue scale (VAS) before starting each treatment session, and at the 1-month and 4-month follow-up appointments. Some validated questionnaires for general health were also complete: SF-36, OHIP-14, Epworth, SCL 90-R and McGill. RESULTS All patients (n = 10) in the study group improved their pain ending treatment and remaining among 90% (n = 9) in the 4-month follow-up. Significant improvement was found in the study group in some sections of McGill questionnaire, Epworth scale, and SCL 90-R at the end of the treatment and in the 1-month and 4-month follow-ups. CONCLUSIONS Photobiomodulation seems to be effective in reducing pain in patients with BMS, as well as, having a positive impact on the psychological state of these patients.",2020,"Significant improvement was found in the study group in some sections of McGill questionnaire, Epworth scale, and SCL 90-R at the end of the treatment and in the 1-month and 4-month follow-ups. ","['burning mouth syndrome (BMS) patients', '20 patients with BMS', 'patients with BMS', 'Burning Mouth Syndrome']","['photobiomodulation', 'Photobiomodulation with Low-Level Laser Therapy', 'placebo']","['pain ending treatment', 'visual analogue scale (VAS', 'Pain', 'McGill questionnaire, Epworth scale, and SCL 90-R', 'pain']","[{'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}]",20.0,0.0644223,"Significant improvement was found in the study group in some sections of McGill questionnaire, Epworth scale, and SCL 90-R at the end of the treatment and in the 1-month and 4-month follow-ups. ","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'de Pedro', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED Research Group, School of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'López-Pintor', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED Research Group, School of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Casañas', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED Research Group, School of Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Hernández', 'Affiliation': 'Department of Dental Clinical Specialties, ORALMED Research Group, School of Dentistry, Complutense University, Madrid, Spain.'}]",Oral diseases,['10.1111/odi.13443'] 2629,32461117,The value of extensive catheter linear ablation on persistent atrial fibrillation (the CLEAR-AF Study).,"BACKGROUND The ablation therapy for persistent atrial fibrillation (PerAF) is still a challenge due to the high recurrence rate. This study was aimed to investigate the value of extensive linear ablation with contact force sensing techniques for PerAF. METHODS A total of 214 patients with PerAF were enrolled in five centers. The patients were randomly assigned to Group I (PVI + LA roof line+ LA anterior wall line) and Group II (PVI + LA roof line), mitral valve isthmus lines were added in both groups if the atrial fibrillation (AF) could not be terminated after all approaches above. RESULTS Acute success rate of AF termination during the ablation procedure in Group I was significantly higher than Group II (P = 0.028). Two-years follow-up showed no significant difference in the sinus rhythm maintenance rate between the two groups (63.4% in group I vs. 57.2% in group II, P = 0.218). More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P = 0.001). The Kaplan-Meier estimates of AF/AT-free survival after repeat ablation procedures were 76.2% in Group I and 47.1% in Group II (P = 0.039). CONCLUSIONS Extensive linear ablation with contact force monitoring did not improve the long-term outcomes for PerAF patients. Repeat ablation procedure showed a possible higher chance of sinus rhythm restoration during follow-up.",2020,"More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P=0.001).","['PerAF patients', '214 patients with PerAF were enrolled in five centers']","['Group I (PVI + LA roof line+ LA anterior wall line) and Group II (PVI + LA roof line), mitral valve isthmus lines', 'extensive catheter linear ablation']","['sinus rhythm restoration', 'sinus rhythm maintenance rate', 'organized atrial tachycardia (AT', 'AF termination']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",214.0,0.015255,"More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P=0.001).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: ianyao@263.net.cn.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhongpeng', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yuhe', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Erpeng', 'Initials': 'E', 'LastName': 'Liang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.032'] 2630,32580919,A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children.,"BACKGROUND Current influenza vaccine effectiveness (VE) improvement efforts focus on minimizing egg adaptation mutations during manufacture. This study compared immune response of two FDA-approved quadrivalent inactivated influenza vaccines in an unblinded randomized controlled trial. METHODS Participants were 144 community dwelling, healthy children/adolescents aged 4-20 years, randomized 1:1 in blocks of 4 to a vaccine grown in cell culture (ccIIV4 [Flucelvax®]; n = 85); or in egg medium (IIV4 [Fluzone ®]; n = 83). Blood was drawn at day 0 prevaccination and at day 28 (19-35 days) post vaccination. Hemagglutination inhibition (HI) assays against A/H1N1 and both B strains and microneutralization (MN) assays against egg-based and cell-based A/H3N2 strains were conducted. The primary outcome measure was seroconversion (day 28/day 0 titer ratio ≥ 4 with day 28 titer ≥ 40). Secondary outcomes were elevated titers (day 28 HI titer ≥ 1:110), geometric mean titers (GMTs) and mean fold rise (MFR) in titers. Outcomes were compared for 74 ccIIV4 recipients and 70 IIV4 recipients, and for those vaccinated and unvaccinated the previous year. Only the HI and MN laboratory analysis team was blinded to group assignment. RESULTS In this racially diverse (81% non-white) group of children with a median age of 14 years, baseline demographics did not differ between vaccine groups. At day 0, half or more in each vaccine group had elevated HI or MN titers. Low seroconversion rates (14%-35%) were found; they did not differ between groups. Among 2018-19 ccIIV4 recipients, those unvaccinated in the previous season showed significantly higher MFR against A/H1N1 and A/H3N2 cell-grown virus than the previously vaccinated. Similar results were found for MFR against B/Victoria among 2018-2019 IIV4 recipients. CONCLUSION In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses. CLINICAL TRIALS NO NCT03614975.",2020,"In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses. ","['≥\xa04 with day 28 titer', 'Participants were 144 community dwelling, healthy children/adolescents aged 4-20\xa0years', 'children']","['2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine', 'vaccine grown in cell culture (ccIIV4 [Flucelvax®]; n\xa0=\xa085); or in egg medium (IIV4 [Fluzone ®', 'FDA-approved quadrivalent inactivated influenza vaccines', 'Hemagglutination inhibition (HI) assays against A/H1N1 and both B strains and microneutralization (MN) assays']","['Low seroconversion rates', 'MFR against B/Victoria', 'antibody titers', 'titer ratio', 'elevated HI or MN titers', 'elevated titers (day 28 HI titer\xa0≥\xa01:110), geometric mean titers (GMTs) and mean fold rise (MFR', 'seroconversion (day 28/day 0']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",144.0,0.30326,"In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses. ","[{'ForeName': 'Krissy K', 'Initials': 'KK', 'LastName': 'Moehling', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Mary Patricia', 'Initials': 'MP', 'LastName': 'Nowalk', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: tnowalk@pitt.edu.'}, {'ForeName': 'Chyongchiou', 'Initials': 'C', 'LastName': 'Jeng Lin', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Alcorn', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA; Department of Immunology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Susick', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Burroughs', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Holiday', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Flannery', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.06.023'] 2631,32469156,Diuretic and renal effects of spironolactone and heart failure hospitalizations: a TOPCAT Americas analysis.,"AIMS It is unclear whether spironolactone reduced heart failure (HF) hospitalizations in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial through potential diuretic or other effects. We examined the effects of spironolactone on weight, diuretic use, and renal function, and their subsequent impact on outcomes. METHODS AND RESULTS We analysed data from TOPCAT Americas (1767 patients with HF and preserved ejection fraction; 886 in spironolactone, 881 in placebo arm). We used mixed-effects models for serial data and shared frailty models to identify determinants of recurrent HF hospitalizations among baseline and serial parameters. There were 800 HF hospitalizations after a median of 3.0 years. Despite more weight loss with spironolactone initially, weight trajectories overlapped after 12 months. Daily furosemide dose (time-averaged Δ: -4.8% vs. +11.6%, P < 0.001) and thiazide use (-4.3% vs. +1.7%; P = 0.003) decreased with spironolactone; however, angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) use decreased also (-13.1% vs. -7.3%; P = 0.004). Serum creatinine increased more with spironolactone (+12.5% vs. +3.5%; P < 0.001). In time-updated models, loop diuretic dose [hazard ratio (HR) per doubling 1.21; 95% confidence interval (CI) 1.10-1.32; P < 0.001], creatinine (HR per doubling 1.28; 95% CI 1.04-1.40; P = 0.019), and ACEI/ARB use (HR 0.82; 95% CI 0.67-1.00; P = 0.048) were associated with HF hospitalizations. However, the effect of spironolactone on HF hospitalizations persisted (HR 0.77; 95% CI 0.62-0.96; P = 0.021) in these models. Results were similar for cardiovascular mortality and time to first HF hospitalization. CONCLUSIONS In TOPCAT Americas, the benefit of spironolactone on outcomes could not be solely attributed to potential diuretic effects, suggesting the presence of non-diuretic mechanisms.",2020,"In time-updated models, loop diuretic dose (HR per doubling 1.21; 95%CI: 1.10-1.32; P<0.001), creatinine (HR per doubling 1.28; 95%CI: 1.04-1.40; P=0.019), and ACEi/ARB use (HR 0.82; 95%CI: 0.67-1.00; P=0.048) were associated with HF hospitalizations.","['We analysed data from TOPCAT Americas (1767 patients with HF and preserved ejection fraction; 886 in spironolactone, 881 in placebo arm', 'and Heart Failure Hospitalizations']","['spironolactone', 'Daily furosemide', 'Spironolactone', 'Aldosterone Antagonist (TOPCAT', 'thiazide']","['weight, diuretic use, and renal function', 'weight trajectories', 'HF hospitalizations', 'heart failure (HF) hospitalizations', 'Serum creatinine', 'cardiovascular mortality and time to first HF hospitalization', 'weight loss', 'ACEi/ARB']","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]",1767.0,0.0687118,"In time-updated models, loop diuretic dose (HR per doubling 1.21; 95%CI: 1.10-1.32; P<0.001), creatinine (HR per doubling 1.28; 95%CI: 1.04-1.40; P=0.019), and ACEi/ARB use (HR 0.82; 95%CI: 0.67-1.00; P=0.048) were associated with HF hospitalizations.","[{'ForeName': 'Andreas P', 'Initials': 'AP', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Jincy', 'Initials': 'J', 'LastName': 'Thankachen', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}]",European journal of heart failure,['10.1002/ejhf.1917'] 2632,32469158,Comparative Analysis between Short Stem and Conventional Femoral Stem in Patients with Osteonecrosis of Femoral Head: Metha Stem and Excia Stem.,"OBJECTIVE To compare the intraoperative, radiological, and clinical short-term outcomes of cementless total hip arthroplasties (THA) using a short stem (SS) and a conventional femoral stem (CS) in a randomized prospective control study. METHODS From June 2011 to October 2017, patients who underwent cementless THA for idiopathic osteonecrosis of the femoral head were recruited. Patients had a minimum 2 years of follow-up after the operation. The patients were divided into two groups: those who underwent THA using an SS and those who underwent THA using a CS. SS were used in 34 patients (41 hips) and CS were used in 41 patients (45 hips). In both groups, the same cup was used in all cases, and the mean follow-up periods were 63 (26-101) months in the SS and 64 (26-101) months in the CS groups. Intraoperative, clinical, and radiological evaluations were performed for the two groups. RESULTS There was no difference in the demographics of the two groups. There was one patient with a proximal femoral crack in the SS group and one with a distal femoral crack in the CS group. Clinically, the mean Harris hip score was improved in both groups at 2-year follow-up. Radiographically endosteal osseointegrations were found in 40 of 41 cases in the SS group and in 44 of 45 cases in the CS group. There was one case of dislocation in each group. In the SS group, the acetabular cup was changed and repositioned 7 months after the initial operation. Stem loosening, infection, ceramic breakage, and varus/valgus change were not observed. There was a statistically significant lower stress shielding effect in the SS group. There were no differences in vertical/parallel offset and leg length discrepancy. CONCLUSION The intraoperative, radiological, and clinical evaluations in both groups showed good outcomes and there was no statistically significant difference between the two groups.",2020,"The intraoperative, radiological, and clinical evaluations in both groups showed good outcomes and there was no statistically significant difference between the two groups.","['From June 2011 to October 2017, patients who underwent cementless THA for idiopathic osteonecrosis of the femoral head were recruited', 'Patients with Osteonecrosis of Femoral Head']","['cementless total hip arthroplasties (THA) using a short stem (SS) and a conventional femoral stem (CS', 'Short Stem and Conventional Femoral Stem', 'THA using an SS and those who underwent THA using a CS']","['Radiographically endosteal osseointegrations', 'Stem loosening, infection, ceramic breakage, and varus/valgus change', 'vertical/parallel offset and leg length discrepancy', 'proximal femoral crack', 'mean Harris hip score', 'stress shielding effect', 'acetabular cup', 'distal femoral crack']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0079949', 'cui_str': 'Osseointegration'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]",,0.015834,"The intraoperative, radiological, and clinical evaluations in both groups showed good outcomes and there was no statistically significant difference between the two groups.","[{'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}, {'ForeName': 'Hyeon Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}, {'ForeName': 'Ki Woong', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Dong Kang Hospital, Ulsan, South Korea.'}, {'ForeName': 'Young Hun', 'Initials': 'YH', 'LastName': 'Jung', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}, {'ForeName': 'Si Young', 'Initials': 'SY', 'LastName': 'Heo', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Dong-A University, Busan,, South Korea.'}]",Orthopaedic surgery,['10.1111/os.12684'] 2633,32580977,Home monitoring with technology-supported management in chronic heart failure: a randomised trial.,"OBJECTIVES We aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients' quality of life than digital home monitoring alone. METHODS In a two-armed partially blinded parallel randomised controlled trial, seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years SD 11.1; left ventricular ejection fraction 32.9% SD 15.4). Participants in both study arms were given a tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. Participants randomised to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of guideline-recommended medical therapy for chronic HF and major comorbidities, measured as a composite opportunity score (total number of recommended treatment given divided by the total number of opportunities the treatment should have been given, with a score 1 indicating 100% adherence to recommendations). Co-primary outcome was change in physical score of Minnesota Living with Heart Failure questionnaire. RESULTS 101 patients were randomised to 'enhanced self-management' and 101 to 'supported medical management'. At the end of follow-up, the opportunity score was 0.54 (95% CI 0.46 to 0.62) in the control arm and 0.61 (95% CI 0.52 to 0.70) in the intervention arm (p=0.25). Physical well-being of participants also did not differ significantly between the groups (17.4 (12.4) mean (SD) for control arm vs 16.5 (12.1) in treatment arm; p for change=0.84). CONCLUSIONS Central provision of tailored specialist management in a multi-morbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life. TRIAL REGISTRATION NUMBER ISRCTN86212709.",2020,"However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life. ","['seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years', 'chronic heart failure', '101 patients']","[""enhanced self-management' and 101 to 'supported medical management"", 'digital home monitoring with centralised specialist support', 'additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment', 'Home monitoring with technology-supported management', 'tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring']","['use of guideline-recommended medical therapy for chronic HF and major comorbidities', 'physical score of Minnesota Living with Heart Failure questionnaire']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0702196', 'cui_str': 'Blood investigation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",202.0,0.142842,"However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life. ","[{'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Rahimi', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom kazem.rahimi@georgeinstitute.ox.ac.uk.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Nazarzadeh', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ana-Catarina', 'Initials': 'AC', 'LastName': 'Pinho-Gomes', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Salimi-Khorshidi', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Fitzpatrick', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Denis', 'Affiliation': 'Oxford Academic Health Science Network, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cleland', 'Affiliation': 'National Heart and Lung Institute, Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-316773'] 2634,32472628,Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke.,"OBJECTIVE The objective of this study was to investigate the safety and efficacy of remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) in the treatment of acute ischemic stroke (AIS). METHODS Patients with AIS who underwent IVT were enrolled and 1:1 randomized to the RIC group and sham-RIC group in this study. RIC (or sham-RIC) was performed twice within 6-24 h of IVT. The subjects in the two groups were followed up for 90 days. The safety outcome included the ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24 h after IVT, and laboratory tests 24 h after IVT. The efficacy outcome included the modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP) tested 24 h after IVT. RESULTS Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited. No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups. In addition, there was no significant difference in mRS score and NIHSS score during the follow-up between groups. However, patients in the RIC group exhibited a significant lower level of hs-CRP compared with the control group (P = 0.048). INTERPRETATION RIC combined with IVT is safe in the treatment of AIS. The neuroprotective and anti-inflammatory effects of this therapy warrant further study on a larger scale.",2020,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","['acute ischemic stroke', 'acute ischemic stroke (AIS', 'Patients with AIS who underwent', 'Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited']","['RIC (or sham-RIC', 'RIC group and sham-RIC', 'IVT', 'remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT', 'Remote ischemic conditioning combined with intravenous thrombolysis']","['ratio of HT, adverse events, blood pressure, coagulation function or liver function', 'mRS score and NIHSS score', 'safety and efficacy', 'modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP', 'level of hs-CRP', 'ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24\xa0h after IVT, and laboratory tests 24\xa0h after IVT']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",,0.0585417,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","[{'ForeName': 'Yao-De', 'Initials': 'YD', 'LastName': 'He', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Zhen-Ni', 'Initials': 'ZN', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Qin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Reziya', 'Initials': 'R', 'LastName': 'Abuduxukuer', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51063'] 2635,32472663,Effects and Mechanisms of Transcutaneous Electrical Acustimulation on Postoperative Recovery After Elective Cesarean Section.,"OBJECTIVES To explore the effects and mechanisms of transcutaneous electrical acustimulation (TEA) on postoperative recovery after cesarean section (CS). MATERIALS AND METHODS A total of 108 women who underwent CS were randomized to receive TEA or sham-TEA. Four hours after CS, electrogastrogram (EGG) and electrocardiogram (ECG) were recorded for 30 min to assess gastric slow waves and autonomic functions, respectively. TEA at ST36 or sham-TEA at non-acupoints was performed for one hour right after recording ECG and EGG and then twice daily from postoperative days (POD) 1 to 3. In the morning of POD4, the EGG and ECG were recorded again for 30 min. RESULTS TEA enhanced postoperative recovery associated with lower GI motility, reflected as a reduction in time of first flatus (p = 0.002) and time of first defecation (p < 0.001), an increase in the Bristol stool score (p < 0.001) and the number of SBMs (p < 0.001) in comparison with sham-TEA. TEA reduced symptoms associated with upper GI motility, including a reduction in time to resume semifluid (p = 0.008), and the total score of loss of appetite (p = 0.003) and belching (p = 0.038) from POD1 to POD3. Physiologically, TEA but not sham-TEA increased the percentage of normal gastric slow waves on POD4 compared with POD0 (p = 0.001). TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001). TEA but not sham-TEA increased vagal activity (p = 0.013) and decreased sympathetic activity (p = 0.013) on POD4 compared with POD0. Two factors were found to be independent predictors of shortened time of the first defecation: the use of TEA and a shorter surgical duration. CONCLUSIONS Needleless non-invasive TEA at ST36 is effective in promoting both lower and upper GI symptoms after CS by enhancing vagal and suppressing sympathetic activities [Correction added on 23 June 2020, after first online publication: The first word of the preceded sentence has been corrected.].",2020,TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001).,"['after cesarean section (CS', '108 women who underwent CS']","['transcutaneous electrical acustimulation (TEA', 'TEA', 'TEA at ST36 or sham-TEA', 'TEA or sham-TEA', 'Transcutaneous Electrical Acustimulation']","['Postoperative Recovery', 'number of SBMs', 'sympathetic activity', 'visual analogue scale (VAS) pain score from POD1 to POD3', 'postoperative recovery', 'vagal activity', 'Bristol stool score', 'percentage of normal gastric slow waves on POD4', 'time to resume semifluid', 'belching', 'total score of loss of appetite', 'time of first flatus', 'electrogastrogram (EGG) and electrocardiogram (ECG', 'time of first defecation']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C4523797', 'cui_str': 'Electrogastrogram'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",108.0,0.194432,TEA reduced the visual analogue scale (VAS) pain score from POD1 to POD3 (p < 0.001).,"[{'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Division of Gastroenterology, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Yinfang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Jingfei', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Division of Obstetrics, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jiande', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13178'] 2636,32472768,Population-level viral suppression among pregnant and postpartum women in a universal test and treat trial.,"OBJECTIVE(S) We sought to determine whether universal 'test and treat' (UTT) can achieve gains in viral suppression beyond universal antiretroviral treatment (ART) eligibility during pregnancy and postpartum, among women living with HIV. DESIGN A community cluster randomized trial. METHODS The SEARCH UTT trial compared an intervention of annual population testing and universal ART with a control of baseline population testing with ART by country standard, including ART eligibility for all pregnant/postpartum women, in 32 communities in Kenya and Uganda. When testing, women were asked about current pregnancy and live births over the prior year and, if HIV-infected, had their viral load measured. Between arms, we compared population-level viral suppression (HIV RNA <500 copies/ml) among all pregnant/postpartum HIV-infected women at study close (year 3). We also compared year-3 population-level viral suppression and predictors of viral suppression among all 15 to 45-year-old women by arm. RESULTS At baseline, 92 and 93% of 15 to 45-year-old women tested for HIV: HIV prevalence was 12.6 and 12.3%, in intervention and control communities, respectively. Among HIV-infected women self-reporting pregnancy/live birth, prevalence of viral suppression was 42 and 44% at baseline, and 81 and 76% (P = 0.02) at year 3, respectively. Among all 15 to 45-year-old HIV-infected women, year-3 population-level viral suppression was higher in intervention (77%) versus control (68%; P < 0.001). Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43). Younger age was a risk factor for nonsuppression in both arms. CONCLUSION The SEARCH intervention resulted in higher population viral suppression among pregnant/postpartum women than a control of baseline universal testing with ART eligibility for pregnant/postpartum women.",2020,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"['all pregnant/postpartum women, in 32 communities in Kenya and Uganda', 'pregnant and postpartum women in a universal test and treat trial', '15 to 45-year-old women by arm', 'women living with HIV']","[""universal 'test and treat' (UTT""]","['year-3 viral suppression', 'HIV: HIV prevalence', 'viral suppression', 'year-3 population-level viral suppression', 'Pregnancy/live birth', 'population viral suppression']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.305022,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kabami', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Balzer', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'Hachem', 'Initials': 'H', 'LastName': 'Saddiki', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mucunguzi', 'Initials': 'M', 'LastName': 'Atukunda', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Koss', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Musoke', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Maya L', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': 'University of California, Berkeley, California, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002564'] 2637,32470574,Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients.,"S-1 is a multicomponent capsule containing tegafur, gimeracil, and oteracil potassium that has shown anticancer activity against numerous tumor types. However, S-1 capsules from different manufacturing companies have shown variations in pharmacokinetics and safety. Therefore, this multicenter, single-dose, randomized-sequence, open-label, two-way, self-crossover study was conducted to evaluate the bioequivalence of a newly developed generic S-1 (New Times Pharmaceutical Co., Ltd., Shandong, China) and the original brand-name S-1 capsule (Taiho Pharmaceutical Co., Ltd., Japan). Furthermore, the safety profiles of both products were compared. A total of 70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals who were randomly and alternatively administered 50 mg of the reference and test S-1 with a 7-day interval. Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ) were determined using non-compartmental analysis with DAS2.0 software. Bioequivalence of the reference and test S-1 was evaluated according to 90% confidence intervals (CIs) for ratios of AUC and C max of S-1. Adverse events were evaluated by monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews. No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation. The 90% CIs of C max , AUC 0-t , and AUC 0-∞ ratios were within the 80%-125% limit. The generic S-1 caused eight mild adverse events including liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity. Similarly, 18 mild adverse events were observed including dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain. There were no differences in the adverse event incidence between the two formulations. In conclusion, the newly developed generic S-1 showed similar pharmacokinetics to those of an original brand-name S-1 in cancer patients, thereby indicating bioequivalence. Furthermore, both treatments were well tolerated, suggesting that the cost-effective generic S-1 should be considered as a feasible option when treating patients.",2020,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","['Chinese cancer patients', '70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals']",['new S-1 capsule'],"['adverse event incidence', 'liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity', 'pharmacokinetics and safety', 'Adverse events', 'Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil', 'dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain', 'monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews', 'maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ', 'plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'Gimeracil'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",70.0,0.0538582,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: hengjianfu@hnca.org.cn.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: lkunyan@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105384'] 2638,32471729,Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study.,"PURPOSE To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD). DESIGN Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis. PARTICIPANTS Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled. METHODS Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4). MAIN OUTCOME MEASURES The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs). RESULTS The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was -144, -145, and -144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids. CONCLUSIONS Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.",2020,"CONCLUSIONS Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","['Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled', 'Neovascular Age-Related Macular Degeneration', '1888', 'Patients (n\xa0', 'naïve patients with neovascular age-related macular degeneration (AMD']","['topical corticosteroids', 'oral and/or injectable corticosteroids', 'Abicipar', 'ranibizumab 0.5 mg every 4 weeks (Q4', 'ranibizumab']","['Intraocular inflammation', 'change from baseline in BCVA and central retinal thickness (CRT', 'Efficacy and Safety', 'Incidence of intraocular inflammation (IOI) AEs', 'proportion of patients with stable vision', 'efficacy and safety', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",1888.0,0.237033,"CONCLUSIONS Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kunimoto', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: derek_kunimoto@yahoo.com.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Sydney Retina Clinic, Sydney, Australia; Save Sight Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana; Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Hansjürgen', 'Initials': 'H', 'LastName': 'Agostini', 'Affiliation': 'Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Souied', 'Affiliation': ""Centre Hospitalier Creteil, Service Universitaire d'Ophthalmologie, Creteil, France.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Chow', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada; Toronto Retina Institute, North York, Ontario, Canada.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lotery', 'Affiliation': 'University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'University Vita-Salute Scientific Institute, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Vision Institute, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Le', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmidt', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Yehia', 'Initials': 'Y', 'LastName': 'Hashad', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.035'] 2639,32579810,Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes.,"BACKGROUND Higher serum urate levels are associated with an increased risk of diabetic kidney disease. Lowering of the serum urate level with allopurinol may slow the decrease in the glomerular filtration rate (GFR) in persons with type 1 diabetes and early-to-moderate diabetic kidney disease. METHODS In a double-blind trial, we randomly assigned participants with type 1 diabetes, a serum urate level of at least 4.5 mg per deciliter, an estimated GFR of 40.0 to 99.9 ml per minute per 1.73 m 2 of body-surface area, and evidence of diabetic kidney disease to receive allopurinol or placebo. The primary outcome was the baseline-adjusted GFR, as measured with iohexol, after 3 years plus a 2-month washout period. Secondary outcomes included the decrease in the iohexol-based GFR per year and the urinary albumin excretion rate after washout. Safety was also assessed. RESULTS A total of 267 patients were assigned to receive allopurinol and 263 to receive placebo. The mean age was 51.1 years, the mean duration of diabetes 34.6 years, and the mean glycated hemoglobin level 8.2%. The mean baseline iohexol-based GFR was 68.7 ml per minute per 1.73 m 2 in the allopurinol group and 67.3 ml per minute per 1.73 m 2 in the placebo group. During the intervention period, the mean serum urate level decreased from 6.1 to 3.9 mg per deciliter with allopurinol and remained at 6.1 mg per deciliter with placebo. After washout, the between-group difference in the mean iohexol-based GFR was 0.001 ml per minute per 1.73 m 2 (95% confidence interval [CI], -1.9 to 1.9; P = 0.99). The mean decrease in the iohexol-based GFR was -3.0 ml per minute per 1.73 m 2 per year with allopurinol and -2.5 ml per minute per 1.73 m 2 per year with placebo (between-group difference, -0.6 ml per minute per 1.73 m 2 per year; 95% CI, -1.5 to 0.4). The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo. The frequency of serious adverse events was similar in the two groups. CONCLUSIONS We found no evidence of clinically meaningful benefits of serum urate reduction with allopurinol on kidney outcomes among patients with type 1 diabetes and early-to-moderate diabetic kidney disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; PERL ClinicalTrials.gov number, NCT02017171.).",2020,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","['persons with type 1 diabetes and early-to-moderate diabetic kidney disease', 'Type 1 Diabetes', 'patients with type 1 diabetes and early-to-moderate diabetic kidney disease', '267 patients']","['placebo', 'allopurinol or placebo', 'allopurinol', 'Allopurinol']","['Safety', 'frequency of serious adverse events', 'baseline-adjusted GFR', 'iohexol-based GFR per year and the urinary albumin excretion rate', 'mean baseline iohexol-based GFR', 'mean serum urate level', 'iohexol-based GFR', 'kidney outcomes', 'mean urinary albumin excretion rate', 'mean iohexol-based GFR', 'glomerular filtration rate (GFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",267.0,0.615998,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Andrzej T', 'Initials': 'AT', 'LastName': 'Galecki', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Cherney', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Parsa', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afkarian', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'M Luiza', 'Initials': 'ML', 'LastName': 'Caramori', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Elliott', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Goldfine', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'J Sonya', 'Initials': 'JS', 'LastName': 'Haw', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Karger', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molitch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Polsky', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Pragnell', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Robiner', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sylvia E', 'Initials': 'SE', 'LastName': 'Rosas', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Senior', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amisha', 'Initials': 'A', 'LastName': 'Wallia', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Chunyi', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916624'] 2640,32461540,Recovery From Exhaustion of the Frank-Starling Mechanism by Mechanical Unloading With a Continuous-Flow Ventricular Assist Device.,"BACKGROUND We describe our original left ventricular assist device (LVAD) speed ramp and volume loading test designed to evaluate native heart function under continuous-flow LVAD support.Methods and Results:LVAD speed was decreased in 4 stages from the patient's optimal speed to the minimum setting for each device. Under minimal LVAD support, patients were subjected to saline loading (body weight [kg]×10 mL in 15 min). Echocardiographic and hemodynamic data were obtained at each stage of the LVAD speed ramp and every 3 min during saline loading. Patients were divided into Recovery (with successful LVAD removal; n=8) and Non-recovery (others; n=31) groups. During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173). Increased cardiac output from volume loading was significantly higher in the Recovery than Non-recovery group (group effect, P=0.0124; time effect, P<0.0001; interaction effect, P=0.0091). Therefore, the Frank-Starling curve of the Recovery group was located upward and to the left of that of the Non-recovery group. CONCLUSIONS The LVAD speed ramp and volume loading test facilitates the precise evaluation of native heart function during continuous-flow LVAD support.",2020,"During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173).",[],['saline loading (body weight'],"['Frank-Starling curve', 'Increased cardiac output from volume loading', 'pulmonary capillary wedge pressure', 'Echocardiographic and hemodynamic data']",[],"[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0326711', 'cui_str': 'Sturnus vulgaris'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0416434,"During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173).","[{'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Surgery, Fukui Cardiovascular Center.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Miyagawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Fusako', 'Initials': 'F', 'LastName': 'Sera', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Nakamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Daimon', 'Affiliation': 'Department of Biostatistics, Hyogo College of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0070'] 2641,32461626,Timing of milk expression following delivery in mothers delivering preterm very low birth weight infants: a randomized trial.,"OBJECTIVE To determine the effect of timing of expression initiation on mother's own milk production and time to secretory activation in mothers of preterm infants. STUDY DESIGN 180 mothers delivering infants ≤1500 grams and ≤32 weeks gestation were randomized to begin expression within 60 (early), 61-180 (intermediate) or 181-360 (late) minutes following delivery. Milk volume was measured on days 1-7 and weekly for 6 weeks. Time to secretory activation was determined through self-report. RESULTS The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045). The late group had more expressions on day 1 (early: p = 0.049; intermediate; p = 0.048). CONCLUSION Initiation of expression at 181-360 min following delivery was associated with increased milk production for 6 weeks following delivery. Further research is needed to determine the effect of expression frequency on milk production in the first days following birth.",2020,The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045).,"['mothers of preterm infants', 'mothers delivering preterm very low birth weight infants', '180 mothers delivering infants', '≤1500 grams and ≤32 weeks gestation']",[],"['milk production', 'Milk volume', 'Time to secretory activation']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0566687', 'cui_str': 'Mother delivered'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",[],"[{'cui': 'C0558187', 'cui_str': 'Lactation established'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",180.0,0.11443,The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045).,"[{'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Parker', 'Affiliation': 'University of Florida, Gainesville, FL, USA. Parkela@ufl.edu.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Kruger', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0688-z'] 2642,32469084,"The impact of high-fidelity simulation on knowledge, critical thinking, and clinical decision-making for the management of pre-eclampsia.","OBJECTIVE To investigate the impact of high-fidelity simulation on nursing students' knowledge, critical thinking, and clinical decision-making in the management of pre-eclampsia, and to explore the students' views and learning experiences. METHODS A mixed-methods design study was conducted on 107 third-year nursing students. The students were randomly assigned to the control group (n=54) or the experimental group (n=53). The students in the experimental group attended the simulation training using a high-fidelity simulator, while the students in the control group attended only the classical training on ""the management of pre-eclampsia."" RESULTS Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation. In the focus group interviews, five themes were identified: learning development; closing the gap between theory and practice; confident decision-making and self-confidence; professional preparation; and recommendations. CONCLUSION High-fidelity simulation is efficacious for improving the management of pre-eclampsia among nursing students.",2020,"RESULTS Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation.",['107 third-year nursing students'],"['simulation training using a high-fidelity simulator, while the students in the control group attended only the classical training on ""the management of pre-eclampsia', 'High-fidelity simulation']",[],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]",[],5.0,0.0259582,"RESULTS Knowledge (P<0.001), critical thinking (P<0.05), and clinical decision-making (P<0.05) scores of students in the experimental group increased after the simulation.","[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Akalin', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Duzce University, Duzce, Turkey.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Sahin', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Ankara Yildirim Beyazit University, Ankara, Turkey.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13243'] 2643,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients. MATERIAL AND METHODS A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end). RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. CONCLUSIONS This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. ","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. ","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869'] 2644,32464420,Whole egg consumption increases plasma choline and betaine without affecting TMAO levels or gut microbiome in overweight postmenopausal women.,"As a crucial part of the symbiotic system, the gut microbiome is metabolically connected to many diseases and conditions, including cardiovascular diseases (CVD). Trimethylamine (TMA) is produced by gut bacteria from dietary choline, betaine, or L-carnitine, and is then converted in the liver to Trimethylamine N-oxide (TMAO), which in turn affects hepatic and intestinal lipid metabolism. Circulating TMAO is positively associated with CVD risk. Because eggs are rich in choline, it has been speculated that their consumption may increase plasma TMAO. In this study, we hypothesized that 2 eggs per day increases plasma TMAO level by altering gut microbiome composition in mildly hypercholesterolemic postmenopausal women. In this randomized, cross-over study, 20 overweight, postmenopausal women were given 2 whole eggs and the equivalent amount of yolk-free substitute as breakfast for 4 weeks, in randomized order, with a 4-week washout in between. Fasting blood draws and stool were collected at the beginning and end of each treatment period. Plasma TMAO, choline, betaine and other metabolites were analyzed using LC/MS, while gut microbiome composition was analyzed using 16S amplicon sequencing. Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments. Gut microbiome composition showed large inter-individual variability at baseline and in response to the treatments. The consumption of 2 eggs per day in overweight, postmenopausal mildly hypercholesterolemic women significantly increased plasma choline and betaine, but did not increase plasma TMAO or alter gut microbiome composition.",2020,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","['mildly hypercholesterolemic postmenopausal women', 'overweight postmenopausal women', '20 overweight, postmenopausal women']",['Trimethylamine (TMA'],"['plasma TMAO', 'plasma TMAO level', 'Plasma TMAO, choline, betaine and other metabolites', 'Plasma choline and betaine', 'Fasting blood draws and stool', 'TMAO level', 'plasma choline and betaine', 'plasma TMAO or alter gut microbiome composition']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0077172', 'cui_str': 'trimethylamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0381708,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bardagjy', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: asteve@ucdavis.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: xctang@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: romisacchi@gmail.com.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Randolph', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: jmrandolph@ucdavis.edu.'}, {'ForeName': 'Francene M', 'Initials': 'FM', 'LastName': 'Steinberg', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: fmsteinberg@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.04.002'] 2645,32482490,Pharmacokinetics of Inhaled Levodopa Administered With Oral Carbidopa in the Fed State in Patients With Parkinson's Disease.,"PURPOSE Levodopa (LD) is the most effective oral pharmacotherapy for the management of motor symptoms in Parkinson's disease. However, LD use is complicated by a progressive shortening of the duration of efficacy of a dose, resulting in episodes of inadequate responsiveness, or OFF periods. OFF periods may also occur unpredictably, partly due to the pharmacokinetic (PK) variability of oral LD, resulting from gastrointestinal dysfunction and from the effects of food on absorption. CVT-301 is a levodopa inhalation powder for the treatment of OFF period symptoms in patients on oral dopa-decarboxylase inhibitor/LD. PK and safety profiles of single dose CVT-301, administered with oral carbidopa (CD) and oral CD/LD, were examined in patients with Parkinson's disease in the fed state. METHODS Eligible patients were aged 30-85 years, with a clinical diagnosis of Parkinson's disease and a body mass index of 18-32 kg/m 2 , and were receiving treatment with a stable regimen that included oral CD/LD (25/100 mg) (total LD, ≤800 mg/d). A high-fat/protein meal was eaten 4-5 h after the administration of the morning oral CD/LD dose. Blood samples for predose PK analysis were obtained after the meal, followed by a single inhaled dose of CVT-301 84 mg (+25 mg of oral CD) or oral CD/LD (25/100 mg) or vice versa in 2 dosing periods in a crossover design. Blood was sampled at 0, 5, 10, 15, 30, and 45 min and at 1, 1.5, 2, 3, and 4 h postdose. Tolerability assessments included treatment-emergent adverse events. FINDINGS Twenty-three patients were enrolled (65.2% male; 87.0% white; mean age, 69.3 years; mean body mass index, 26.9 kg/m 2 ; mean Parkinson's disease duration, 8.2 years; mean baseline LD dosage, 460.9 mg/d; 73.9% at Hoehn and Yahr stage <2.5). PK analyses were based on LD concentrations without baseline adjustment. Median T max values with CVT-301 and oral CD/LD were 15 and 120 min (P < 0.001). C max with CVT-301 was lower than with oral CD/LD (590.3 vs 844.3 ng/mL). C 10min and C 30min values with CVT-301 were approximately twice those with CD/LD (522.9 and 531.5 ng/mL vs 247.3 and 300.9 ng/mL, respectively). %CV for C 5min to C max with CVT-301 was lower than that with oral CD/LD. The most common treatment-emergent adverse event was cough (CVT-301, 7 patients [30.4%]; oral CD/LD, 1 patient [4.5%]). IMPLICATIONS PK properties showed that CVT-301 was more rapidly absorbed, with higher plasma LD concentrations in the first 45 min, and demonstrated lower interpatient variability, than was oral CD/LD in the fed condition. The study findings suggest that CVT-301 can be used without regard to food intake. ClinicalTrials.gov identifier: NCT03887884.",2020,C max with CVT-301 was lower than with oral CD/LD (590.3 vs 844.3 ,"[""Patients With Parkinson's Disease"", ""Twenty-three patients were enrolled (65.2% male; 87.0% white; mean age, 69.3 years; mean body mass index, 26.9\xa0kg/m 2 ; mean Parkinson's disease duration, 8.2 years; mean baseline LD dosage, 460.9\xa0mg/d; 73.9% at Hoehn and Yahr stage <2.5"", 'patients on oral dopa-decarboxylase inhibitor/LD', ""patients with Parkinson's disease in the fed state"", ""Eligible patients were aged 30-85 years, with a clinical diagnosis of Parkinson's disease and a body mass index of 18-32\xa0kg/m 2 , and were receiving treatment with a stable regimen that included oral CD/LD (25/100\xa0mg) (total LD, ≤800""]","['Levodopa (LD', 'CVT-301, administered with oral carbidopa (CD) and oral CD/LD', 'CVT-301 84\xa0mg (+25\xa0mg of oral CD) or oral CD/LD', 'CVT-301', 'oral CD/LD', 'Inhaled Levodopa Administered With Oral Carbidopa']","['C max with CVT-301', 'Median T max values with CVT-301 and oral CD/LD', 'Tolerability assessments included treatment-emergent adverse events', 'plasma LD concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0598272', 'cui_str': 'Dopa decarboxylase inhibitor'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",23.0,0.0517237,C max with CVT-301 was lower than with oral CD/LD (590.3 vs 844.3 ,"[{'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Safirstein', 'Affiliation': 'MD Clinical, Hallandale Beach, FL, USA. Electronic address: bsafirstein@mdclinical.org.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ellenbogen', 'Affiliation': 'Quest Research Institute, Bingham Farms, MI, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Acorda Therapeutics, Inc, Ardsley, NY, USA.'}, {'ForeName': 'Herbert R', 'Initials': 'HR', 'LastName': 'Henney', 'Affiliation': 'Private Consultancy, West Grove, PA, USA.'}, {'ForeName': 'Deena M', 'Initials': 'DM', 'LastName': 'Kegler-Ebo', 'Affiliation': 'Acorda Therapeutics, Inc, Ardsley, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Inc, Ardsley, NY, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.004'] 2646,32486007,No Significant Differences in Muscle Growth and Strength Development When Consuming Soy and Whey Protein Supplements Matched for Leucine Following a 12 Week Resistance Training Program in Men and Women: A Randomized Trial.,"There are conflicting reports regarding the efficacy of plant versus animal-derived protein to support muscle and strength development with resistance training. The purpose of this study was to determine whether soy and whey protein supplements matched for leucine would comparably support strength increases and muscle growth following 12 weeks of resistance training. Sixty-one untrained young men ( n = 19) and women ( n = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women). All participants engaged in supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine. Multi-level modeling indicated that total body mass (0.68 kg; 95% CI: 0.08, 1.29 kg; p < 0.001), lean body mass (1.54 kg; 95% CI: 0.94, 2.15 kg; p < 0.001), and peak torque of leg extensors (40.27 Nm; 95% CI: 28.98, 51.57 Nm, p < 0.001) and flexors (20.44 Nm; 95% CI: 12.10, 28.79 Nm; p < 0.001) increased in both groups. Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm; p = 0.08). No differences between groups were observed ( p > 0.05). These data indicate that increases in lean mass and strength in untrained participants are comparable when strength training and supplementing with soy or whey matched for leucine.",2020,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm; p = 0.08).","['Sixty-one untrained young men ( n = 19) and women ( n = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women', 'untrained participants', 'Men and Women']","['Resistance Training Program', 'soy and whey protein supplements matched for leucine', 'supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine', 'Consuming Soy and Whey Protein Supplements Matched for Leucine']","['lean mass and strength', 'total body mass', 'lean body mass', 'Vastus lateralis muscle thickness', 'Muscle Growth and Strength Development', 'peak torque of leg extensors']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0677666', 'cui_str': 'soy protein isolate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",61.0,0.0891844,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm; p = 0.08).","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Lynch', 'Affiliation': 'Department of Kinesiology, Point Loma Nazarene University, San Diego, CA 92106, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Health Sciences, Central Washington University, Ellensburg, WA, 98926, USA.'}, {'ForeName': 'Lynda B', 'Initials': 'LB', 'LastName': 'Ransdell', 'Affiliation': 'College of Health and Human Services, Northern Arizona University, Flagstaff, AZ 86011, USA.'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Johnston', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Wharton', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113871'] 2647,32484754,Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial.,"PURPOSE The oligometastatic paradigm hypothesizes that patients with a limited number of metastases may achieve long-term disease control, or even cure, if all sites of disease can be ablated. However, long-term randomized data that test this paradigm are lacking. METHODS We enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to stereotactic ablative radiotherapy (SABR). We stratified by the number of metastases (1-3 v 4-5) and randomized in a 1:2 ratio between palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR (arm 2). We used a randomized phase II screening design with a primary end point of overall survival (OS), using an α of .20 (wherein P < .20 indicates a positive trial). Secondary end points included progression-free survival (PFS), toxicity, and quality of life (QOL). Herein, we present long-term outcomes from the trial. RESULTS Between 2012 and 2016, 99 patients were randomly assigned at 10 centers internationally. The most common primary tumor types were breast (n = 18), lung (n = 18), colorectal (n = 18), and prostate (n = 16). Median follow-up was 51 months. The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P = .006). The 5-year PFS rate was not reached in arm 1 (3.2%; 95% CI, 0% to 14% at 4 years with last patient censored) and 17.3% in arm 2 (95% CI, 8% to 30%; P = .001). There were no new grade 2-5 adverse events and no differences in QOL between arms. CONCLUSION With extended follow-up, the impact of SABR on OS was larger in magnitude than in the initial analysis and durable over time. There were no new safety signals, and SABR had no detrimental impact on QOL.",2020,"The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P = .006).","['99 patients were randomly assigned at 10 centers internationally', 'patients with a limited number of metastases', 'Oligometastatic Cancers', 'Between 2012 and 2016', 'enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to']","['stereotactic ablative radiotherapy (SABR', 'Stereotactic Ablative Radiotherapy', 'palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR', 'SABR']","['5-year PFS rate', 'QOL', '5-year OS rate', 'overall survival (OS', 'progression-free survival (PFS), toxicity, and quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0449798', 'cui_str': 'Number of metastases'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",99.0,0.206806,"The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P = .006).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Olson', 'Affiliation': 'BC Cancer, Centre for the North, Prince George, British Columbia, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrow', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Gaede', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Haasbeek', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Mulroy', 'Affiliation': 'Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Yaremko', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Schellenberg', 'Affiliation': 'BC Cancer, Surrey Centre, Surrey, British Columbia, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Sashendra', 'Initials': 'S', 'LastName': 'Senthi', 'Affiliation': 'Alfred Health Radiation Oncology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaminath', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kopek', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BC Cancer, Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Currie', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Schlijper', 'Affiliation': 'BC Cancer, Centre for the North, Prince George, British Columbia, Canada.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Bauman', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Laba', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'X Melody', 'Initials': 'XM', 'LastName': 'Qu', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00818'] 2648,32580990,"OASIS-a randomised, placebo-controlled trial of oral glucocorticoids for leg pain in patients with acute sciatica: trial protocol.","INTRODUCTION Sciatica is a lower spine condition characterised by radiating leg pain below the knee. It may be accompanied by motor and sensory loss in the distribution of a spinal nerve. There are few effective treatments for sciatica. Orally administered glucocorticoids have shown some promise, however, any beneficial effects need to be confirmed and weighed against drug safety and cost-effectiveness, in a high-quality, definitive trial. METHODS AND ANALYSIS The Oral Steroids In Sciatica (OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica. Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments and randomised to receive orally administered prednisolone 50 mg per day, up to 3 days then tapering to cessation over 10 days, or placebo, for a maximum of 13 days, in addition to guideline advice. Participants will be followed for 1 year. The primary endpoint will be leg pain intensity at 2 weeks. Secondary outcomes will include back pain intensity, disability, time to recovery, quality of life and treatment success rate. Adverse events will be assessed and a cost-effectiveness analysis will be conducted. ETHICS AND DISSEMINATION Ethical approval has been granted from the Human Research Ethics Committee, The University of Sydney. Trial results will be disseminated by publications and conference presentations and via the media. TRIAL REGISTRATION NUMBER ACTRN12619001716156.",2020,"(OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica.","['200 participants with acute sciatica', 'Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments', 'patients with acute sciatica']","['oral prednisolone', 'oral glucocorticoids', 'glucocorticoids', 'prednisolone', 'placebo']","['leg pain', 'back pain intensity, disability, time to recovery, quality of life and treatment success rate', 'leg pain intensity']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",200.0,0.722215,"(OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica.","[{'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia chang.liu1@sydney.edu.au.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Abdel Shaheed', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Sydney Pharmacy School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': 'Department of Clinical Pharmacology & Toxicology, St Vincent Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Richards', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Juliana S', 'Initials': 'JS', 'LastName': 'Oliveira', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040559'] 2649,32581009,Use of Aspirin and Statins in Relation to Inflammation in Benign Prostate Tissue in the Placebo Arm of the Prostate Cancer Prevention Trial.,"Aspirin and statin use may lower risk of advanced/fatal prostate cancer, possibly by reducing intraprostatic inflammation. To test this hypothesis, we investigated the association of aspirin and statin use with the presence and extent of intraprostatic inflammation, and the abundance of specific immune cell types, in benign prostate tissue from a subset of men from the placebo arm of the Prostate Cancer Prevention Trial. Men were classified as aspirin or statin users if they reported use at baseline or during the seven-year trial. Presence and extent of inflammation were assessed, and markers of specific immune cell types (CD4, CD8, FoxP3, CD68, c-KIT) were scored, in slides from end-of-study prostate biopsies taken irrespective of clinical indication, per trial protocol. Logistic regression was used to estimate associations between medication use and inflammation measures, adjusted for potential confounders. Of 357 men included, 61% reported aspirin use and 32% reported statin use. Prevalence and extent of inflammation were not associated with medication use. However, aspirin users were more likely to have low FoxP3, a T regulatory cell marker (OR: 5.60, 95% CI: 1.16-27.07), and statin users were more likely to have low CD68, a macrophage marker (OR: 1.63, 95% CI: 0.81-3.27). If confirmed, these results suggest that these medications may alter the immune milieu of the prostate, which could potentially mediate effects of these medications on advanced/fatal prostate cancer risk.",2020,Prevalence and extent of inflammation were not associated with medication use.,"['benign prostate tissue from a subset of men from the placebo arm of the Prostate Cancer Prevention Trial', 'Men were classified as aspirin or statin users if they reported use at baseline or during the seven-year trial', 'Of 357 men included, 61% reported aspirin use and 32% reported statin use']","['aspirin and statin', 'aspirin', 'Aspirin and statin', 'Aspirin and Statins']","['specific immune cell types (CD4, CD8, FoxP3, CD68, c-KIT']","[{'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0072470', 'cui_str': 'Lymphocyte antigen CD117'}]",357.0,0.0896527,Prevalence and extent of inflammation were not associated with medication use.,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Hurwitz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Kulac', 'Affiliation': 'Pathology, Koc University.'}, {'ForeName': 'Berrak', 'Initials': 'B', 'LastName': 'Gumuskaya', 'Affiliation': 'Pathology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Baena Del Valle', 'Affiliation': 'Fundacion Santa Fe de Bogota University Hospital.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Benedetti', 'Affiliation': 'Basic Sciences, University of Cartagena.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'Immunology and Hematopoiesis Division, Department of Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Jun O', 'Initials': 'JO', 'LastName': 'Liu', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Marrone', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Arnold', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'SWOG Statistical Center, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'SWOG Statistical Center, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado School of Medicine.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Administration, CHRISTUS Santa Rosa Hospital - Medical Center.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Department of Urology, and the Columbia Center for Translational Immunology (CCTI), Columbia University Herbert Irving Comprehensive Cancer Center.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Isaacs', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Nelson', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Platz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health eplatz1@jhu.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0450'] 2650,32581041,Hyperprogression to camrelizumab in a patient with esophageal squamous cell carcinoma harboring EGFR kinase domain duplication.,"BACKGROUND Previous studies have reported that the amplification of some genes, such as Murine Double Minute 2 or 4 and Epidermal Growth Factor Receptor ( EGFR ), may be related to hyperprogressive disease (HPD). Exploring somatic gene alterations might be an effective method to predict HPD. Herein we characterize the somatic alterations in a patient with esophageal squamous cell carcinoma (ESCC) who developed HPD to investigate the potential origins of HPD. CASE PRESENTATION A man in his mid-40s was diagnosed with ESCC. After the failure of first-line treatment with cisplatin and docetaxel, the patient participated in a phase III randomized, open, multicenter clinical trial (CTR20170307) and subsequently received camrelizumab. After 4 weeks of immunotherapy, the tumor size increased by 79% compared with baseline imaging; the progressive pace was 2.5-fold higher than preimmunotherapy, and a new liver metastasis appeared. A rare EGFR exon 2-28 duplication was discovered in both preimmunotherapy and postimmunotherapy tumor tissues. CONCLUSION This is the first report on a patient with ESCC harboring rare EGFR kinase domain duplication in exons 2-28 and developing HPD in the process of camrelizumab treatment. This case suggested that EGFR kinase domain duplication might be associated with HPD. Administration of immune checkpoint inhibitor monotherapy in this subgroup of patients harboring EGFR kinase domain duplication should be performed with caution. These results need to be further confirmed in a larger cohort of patients.",2020,"After 4 weeks of immunotherapy, the tumor size increased by 79% compared with baseline imaging; the progressive pace was 2.5-fold higher than preimmunotherapy, and a new liver metastasis appeared.","['A man in his mid-40s was diagnosed with ESCC', 'patient with esophageal squamous cell carcinoma harboring EGFR kinase domain duplication', 'patient with esophageal squamous cell carcinoma (ESCC']","['Double Minute 2 or 4 and Epidermal Growth Factor Receptor ( EGFR ', 'camrelizumab', 'Hyperprogression to camrelizumab', 'cisplatin and docetaxel', 'immune checkpoint inhibitor monotherapy']","['tumor size', 'progressive pace']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]",,0.0305784,"After 4 weeks of immunotherapy, the tumor size increased by 79% compared with baseline imaging; the progressive pace was 2.5-fold higher than preimmunotherapy, and a new liver metastasis appeared.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Meihong', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Minglu', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Zhengqing', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'The Medical Department, 3D Medicines Inc, Shanghai, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'The Medical Department, 3D Medicines Inc, Shanghai, China.'}, {'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Mao', 'Affiliation': 'Department of Oncology, North Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, North Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, China 13601810867@163.com.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000793'] 2651,32581042,Serum interleukin-6 and C-reactive protein are associated with survival in melanoma patients receiving immune checkpoint inhibition.,"BACKGROUND Inflammatory mediators, including acute phase reactants and cytokines, have been reported to be associated with clinical efficacy in patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI). Analyses of patient sera from three large phase II/III randomized ICI trials, one of which included a chemotherapy arm, were performed to assess whether baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios were prognostic or predictive. PATIENTS AND METHODS Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of nivolumab followed by ipilimumab or the reverse sequence. Baseline sera, and peripheral blood mononuclear cells using automated cell counting, were analyzed from treatment-naïve patients who were BRAF wild-type and randomly allocated 1:1 to receive nivolumab or dacarbazine on the phase III Checkmate-066 trial, and from treatment-naïve patients allocated 1:1:1 to receive nivolumab, ipilimumab or both ipilimumab and nivolumab on the phase III Checkmate-067 trial. RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy. Increased on-treatment levels of IL-6 in patients on the Checkmate-064 study were also associated with shorter survival. IL-6 levels from patients on Checkmate-064, Checkmate-066 and Checkmate-067 were highly correlated with levels of CRP and the N/L ratio. CONCLUSION IL-6, CRP and the N/L ratio are prognostic factors with higher levels associated with shorter overall survival in patients with metastatic melanoma receiving ICI or chemotherapy in large randomized trials. In a multi-variable analysis of the randomized phase III Checkmate-067 study, IL-6 was a significant prognostic factor for survival.",2020,"RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","['melanoma patients receiving immune checkpoint inhibition', 'Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of', 'patients with metastatic melanoma receiving', 'patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI', 'naïve patients who were BRAF wild-type']","['nivolumab, ipilimumab or both ipilimumab and nivolumab', 'nivolumab followed by ipilimumab', 'nivolumab or dacarbazine', 'ICI or chemotherapy']","['baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios', 'IL-6 levels', 'overall survival', 'IL-6', 'shorter survival']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.152016,"RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","[{'ForeName': 'Andressa S', 'Initials': 'AS', 'LastName': 'Laino', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Woods', 'Affiliation': 'Department of Medicine, University of Colorado Denver-Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Vassallo', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wind-Rotolo', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA Jeffrey.Weber@nyulangone.org.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000842'] 2652,32581204,[Therapeutic Response to 20 mg of Esomeprazole Twice Daily in Patients with Gastroesophageal Reflux Disease-related Non-cardiac Chest Pain: An Open-Label Randomized Pilot Study].,"Background/Aims Non-cardiac chest pain (NCCP) is defined as recurrent angina pectoris-like pain without evidence of coronary heart disease, and is usually related to esophageal diseases, such as gastroesophageal reflux disease (GERD). Proton pump inhibitors (PPIs) are important for diagnosis and treatment. Many studies have been conducted on the use of PPIs in patients with GERD-related NCCP. In contrast to standard-dose esomeprazole, the efficacy of half-dose esomeprazole twice daily (BD) has not been established. This study compared the efficacies of the two esomeprazole regimens in GERD-related NCCP. Methods In this prospective, open-label study, 37 participants with GERD-related NCCP were randomized to receive either 20 mg of esomeprazole BD (n=21) (esomeprazole BD group) or 40 mg once daily (n=16) (esomeprazole once daily [OD] group) for 4 weeks. In both groups, the chest pain score, which was calculated based on the frequency and severity, was evaluated before and 2 and 4 weeks after administering the medication. Results The chest pain score significantly improved in both groups (p<0.001). The proportion of patients with chest pain score improvement >50% was 7.7% higher in the esomeprazole BD group than in the esomeprazole OD group (95.2% vs. 87.5%), but the difference was not significant. Conclusions Esomeprazole BD was as effective as esomeprazole OD in improving GERD-related NCCP. Although statistically insignificant, the percentage of patients with >50% reduction in the chest pain score was higher in the esomeprazole BD group than in the esomeprazole OD group. Large-scale studies will be needed to assess these findings further.",2020,The chest pain score significantly improved in both groups (p<0.001).,"['patients with GERD-related NCCP', '37 participants with GERD-related NCCP', 'Patients with Gastroesophageal Reflux Disease-related Non-cardiac Chest Pain']","['esomeprazole OD', 'esomeprazole BD', 'esomeprazole', '/Aims\n\n\nNon-cardiac chest pain (NCCP', 'esomeprazole BD (n=21) (esomeprazole BD group) or 40 mg once daily (n=16) (esomeprazole', 'Esomeprazole BD', 'Esomeprazole', 'Proton pump inhibitors (PPIs']","['chest pain score', 'proportion of patients with chest pain score improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",37.0,0.0232623,The chest pain score significantly improved in both groups (p<0.001).,"[{'ForeName': 'Jae Kyun', 'Initials': 'JK', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Hyun Ik', 'Initials': 'HI', 'LastName': 'Shim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}]",The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi,['10.4166/kjg.2020.75.6.333'] 2653,32581275,Publisher Correction: Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['individuals with prehypertension or hypertension'],"['Publisher Correction', 'exercise training modalities']",['endothelial function improvements'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0456419,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-67586-2'] 2654,32581313,Effect of an antioxidant supplement containing high dose lutein and zeaxanthin on macular pigment and skin carotenoid levels.,"The effect of a high dose lutein/zeaxanthin supplement on macular pigment optical density (MPOD) and skin carotenoid (SC) levels in healthy subjects was investigated. This is a prospective, single-arm, open-label study. Subjects were 16 Japanese, age 26-57 years. Subjects took a supplement containing 20 mg/day of lutein, 4 mg/day of zeaxanthin, and other antioxidants (vitamin C, vitamin E, zinc, copper) for 16 weeks. MPOD levels were measured by a two-wavelength autofluorescence imaging technique. SC levels were measured by reflection spectroscopy. Total volume of MPOD within 9° eccentricity significantly increased by week 8 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). The increase rate of MPOD was significantly higher in subjects with body mass index (BMI) less than 25 kg/m 2 (n = 13) compared to those of 25 kg/m 2 and higher (n = 3). SC levels increased significantly by week 4 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). All subjects completed the study without any serious adverse events. These results demonstrated the effectiveness of a high dose lutein/zeaxanthin supplement for MPOD volume and SC levels without serious adverse events.",2020,The increase rate of MPOD was significantly higher in subjects with body mass index,"['subjects with body mass index', 'healthy subjects', 'Subjects were 16 Japanese, age 26-57 years']","['lutein/zeaxanthin supplement', 'antioxidant supplement containing high dose lutein and zeaxanthin', 'supplement containing 20\u2009mg/day of lutein, 4\u2009mg/day of zeaxanthin, and other antioxidants (vitamin C, vitamin E, zinc, copper', 'lutein/zeaxanthin']","['macular pigment and skin carotenoid levels', 'rate of MPOD', 'macular pigment optical density (MPOD) and skin carotenoid (SC) levels', 'SC levels', 'Total volume of MPOD within 9° eccentricity', 'MPOD levels', 'MPOD volume and SC levels']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2929534', 'cui_str': 'Lutein / zeaxanthin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0009968', 'cui_str': 'Copper'}]","[{'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0233047,The increase rate of MPOD was significantly higher in subjects with body mass index,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Obana', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan. obana@sis.seirei.or.jp.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Gohto', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Department of Ophthalmology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Gellermann', 'Affiliation': 'Longevity Link Corporation, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Bernstein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Moran Eye Center, University of Utah School of Medicine, Salt Lake City, Utah, United States of America.'}]",Scientific reports,['10.1038/s41598-020-66962-2'] 2655,32581473,"Postoperative Pain with Hand, Reciprocating, and Rotary Instrumentation Techniques after Root Canal Preparation in Primary Molars: A Randomized Clinical Trial.","Aim The purpose of this randomized clinical trial was to evaluate the intensity and duration of postoperative pain after pulpectomy of primary teeth using three preparation techniques. Materials and methods A total of 60 patients were randomly allocated to three groups of 20 patients each, according to the root canal instrumentation techniques used. In group I, the teeth were prepared using manual NiTi K flex files till size 35. In group II, the teeth were prepared using NiTi K flex files till size 35 in reciprocating motion. In group III, the teeth were prepared using Kedo-S pediatric rotary files. After root canal preparation, the canals were obturated with endoflas paste and were restored permanently with composite filling material. The intensity and duration of postoperative pain were evaluated after 6, 12, 24, 48, and 72 hours, using a four-point pain-intensity scale. Results There was a statistically significant difference among the groups, wherein the postoperative pain was more in NiTi K flex files used in reciprocating motion followed by manual NiTi K flex files and Kedo-S pediatric rotary files. Conclusion Postoperative pain was more with NiTi K flex files in reciprocating motion and was less with Kedo-S rotary files after root canal preparation in primary maxillary molars. How to cite this article Jeevanandan G, Ravindran V, Subramanian EMG, et al. Postoperative Pain with Hand, Reciprocating, and Rotary Instrumentation Techniques after Root Canal Preparation in Primary Molars: A Randomized Clinical Trial. Int J Clin Pediatr Dent 2020;13(1):21-26.",2020,"There was a statistically significant difference among the groups, wherein the postoperative pain was more in NiTi K flex files used in reciprocating motion followed by manual NiTi K flex files and Kedo-S pediatric rotary files. ","['Primary Molars', '60 patients']",['Int J Clin Pediatr Dent'],"['Postoperative Pain with Hand, Reciprocating, and Rotary Instrumentation Techniques', 'intensity and duration of postoperative pain', 'postoperative pain']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",60.0,0.0561934,"There was a statistically significant difference among the groups, wherein the postoperative pain was more in NiTi K flex files used in reciprocating motion followed by manual NiTi K flex files and Kedo-S pediatric rotary files. ","[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Jeevanandan', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Ravindran', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Erulappan Mg', 'Initials': 'EM', 'LastName': 'Subramanian', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Aravind S', 'Initials': 'AS', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthodontics, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1709'] 2656,32581474,A Comparative Evaluation of Pain Perception and Comfort of a Patient Using Conventional Syringe and Buzzy System.,"Aim and objective To evaluate the pain perception and comfort of patient during local anesthesia (LA) delivery using Buzzy system and conventional syringe. Materials and methods Fifty children aged 5 to 10 years were randomly divided into two groups, the main inclusion criteria being administration of LA for dental treatment. Parameters include Wong Baker face pain reading scale (WBFPRS) for subjective evaluation and pulse oximeter and face leg activity crying consolability (FLACC) scale for objective evaluation. The values obtained were statistically analyzed. Results FLACC score was higher in conventional group as compared to the Buzzy group, which was statistically significant. Conclusion External cold and vibration via Buzzy can reduce pain and anxiety during LA delivery. How to cite this article Suohu T, Sharma S, Marwah N, et al. A Comparative Evaluation of Pain Perception and Comfort of a Patient Using Conventional Syringe and Buzzy System. Int J Clin Pediatr Dent 2020;13(1):27-30.",2020,"Results FLACC score was higher in conventional group as compared to the Buzzy group, which was statistically significant. ",['Fifty children aged 5 to 10 years'],"['LA', 'External cold and vibration via Buzzy', 'Conventional Syringe and Buzzy System', 'local anesthesia (LA) delivery using Buzzy system and conventional syringe']","['pain and anxiety', 'pain perception and comfort', 'Baker face pain reading scale (WBFPRS) for subjective evaluation and pulse oximeter and face leg activity crying consolability (FLACC) scale for objective evaluation', 'FLACC score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0243307,"Results FLACC score was higher in conventional group as compared to the Buzzy group, which was statistically significant. ","[{'ForeName': 'Thejavinuo', 'Initials': 'T', 'LastName': 'Suohu', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Mahatma Gandhi Dental College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Dental Institute, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Marwah', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Mahatma Gandhi Dental College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Mahatma Gandhi Dental College, Jaipur, Rajasthan, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1731'] 2657,32581595,Efficacy and Safety of Cyclin-Dependent Kinases 4 and 6 Inhibitors in HR+/HER2- Advanced Breast Cancer.,"Purpose To assess the efficacy and safety of cyclin-dependent kinases 4 and 6 inhibitors (CDKi) combined with endocrine therapy (ET) in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) and compare the efficacy of different CDKi (palbociclib, ribociclib, or abemaciclib). Materials and Methods This study based on randomized Phase 2 or 3 trials of CDKi plus ET compared with placebo plus ET for women with HR+/HER2-ABC and identify relevant randomized clinical trials (RCTs) published prior to February 2020. The primary endpoint was progression-free survival (PFS), the secondary endpoints included overall survival (OS), objective response rate (ORR), clinical benefit response (CBR) and safety. The PROSPERO registry number is 42018081105. Results The results from eight trials including 4580 participants were pooled. Evidence indicated that the PFS of CDKi group was significantly prolonged (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.50-0.60, P < 0.01) compared with placebo group. The ORR and CBR were better (risk ratio [RR] 1.47, 95% CI 1.30-1.67, P < 0.01; 1.24, 95% CI 1.15-1.35, P < 0.01) in the CDKi group. The OS of CDKi group (HR 0.75, 95% CI 0.67-0.85, P < 0.01) was significantly longer than ET alone. Subgroup analyses confirmed that the benefit was consistent across most subgroups. Subgroup analyses showed no statistically significant difference of PFS among three CDKi: palbociclib vs ribociclib (HR 0.55, 95% CI 0.49-0.60, P = 0.34), palbociclib vs abemaciclib (HR 0.53, 95% CI, 0.47-0.59, P = 0.61), and ribociclib vs abemaciclib (HR 0.56, 95% CI, 0.51-0.62, P = 0.72). Treatment-related grade 3 or 4 hematologic adverse events (AEs) were more frequently in CDKi group. Conclusion CDKi combined with ET can significantly prolong PFS and improve the ORR, CBR and OS in patients with HR+/HER2- ABC. However, the advantage of different CDKi has not been established.",2020,"The OS of CDKi group (HR 0.75, 95% CI 0.67-0.85, P < 0.01) was significantly longer than ET alone.","['women with HR+/HER2-ABC and identify relevant randomized clinical trials (RCTs) published prior to February 2020', 'patients with HR+/HER2- ABC', '4580 participants were pooled', 'HR+/HER2- Advanced Breast Cancer', 'women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC']","['cyclin-dependent kinases 4 and 6 inhibitors (CDKi) combined with endocrine therapy (ET', 'Cyclin-Dependent Kinases 4 and 6 Inhibitors', 'CDKi combined with ET', 'CDKi plus ET', 'placebo plus ET', 'placebo']","['Efficacy and Safety', 'PFS', 'overall survival (OS), objective response rate (ORR), clinical benefit response (CBR) and safety', 'hematologic adverse events (AEs', 'efficacy and safety', 'ORR, CBR and OS', 'progression-free survival (PFS', 'ORR and CBR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0246957', 'cui_str': 'PSK-J3 Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4580.0,0.372675,"The OS of CDKi group (HR 0.75, 95% CI 0.67-0.85, P < 0.01) was significantly longer than ET alone.","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xie', 'Affiliation': ""Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangzhou, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Qin', 'Affiliation': ""Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': ""Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangzhou, People's Republic of China.""}, {'ForeName': 'Herui', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': ""Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yunfang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangzhou, People's Republic of China.""}, {'ForeName': 'Huangming', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': ""Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangzhou, People's Republic of China.""}]",Cancer management and research,['10.2147/CMAR.S254365'] 2658,32581597,"Measurement Equivalence of ""Touch-Screen"" versus ""Paper-Based"" Assessments of OHRQoL: A Randomized Crossover Trial.","Purpose To determine the measurement equivalence of computer touch screen assessment (CTSA) and paper based assessment (PBA) of the oral health impact profile (OHIP-14). Patients and Methods A randomized crossover trial was conducted. Sixty participants were randomized to either i) Arm A: completed CTSA then PBA of OHIP-14, or ii) Arm B: PBA and then CTSA of OHIP-14 within the same day. User preference and time taken to complete the assessments were recorded. Agreement between CTSA and PBA was determined using directional difference (DD), absolute difference (AD), and intraclass correlation coefficient (ICC). Results There was no significant difference in CTSA and PBA OHIP-14 scores ( P >0.05). The magnitude of the DD in scores between assessment methods was small for overall scores and all domains (<0.3). The AD in OHIP-14 scores was small (~6% for overall score, between 8-16% for domains). Agreement between CTSA and PBA was high (ICC=0.9; 95% CI=0.8-0.9) for overall OHIP-14 scores, but ICC values varied across domains. Most (78%) preferred CTSA. There was no significant difference in time taken to complete assessments ( P =0.09). Regression analyses did not identify any significant socio-demographic factor associated with absolute difference between CTSA and PBA scores. Conclusion There is equivalence of measurements in OHRQoL assessments from CTSA and PBA, and the time taken to complete assessment by either means is similar. There is a greater preference for CTSA. This has implications to support the use of CTSA in OHRQoL assessments.",2020,There was no significant difference in CTSA and PBA OHIP-14 scores ( P >0.05).,['Sixty participants were randomized to either i'],"['Touch-Screen"" versus ""Paper-Based"" Assessments of OHRQoL', 'computer touch screen assessment (CTSA) and paper based assessment (PBA']","['OHIP-14 scores', 'directional difference (DD), absolute difference (AD), and intraclass correlation coefficient (ICC', 'time taken to complete assessments', 'overall OHIP-14 scores', 'CTSA and PBA OHIP-14 scores']",[],"[{'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",60.0,0.0506751,There was no significant difference in CTSA and PBA OHIP-14 scores ( P >0.05).,"[{'ForeName': 'Maznurfarhatunnisak', 'Initials': 'M', 'LastName': 'Anowar', 'Affiliation': 'Department of Community Oral Health & Clinical Prevention, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': ""Dental Public Health, Faculty of Dentistry, University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Roslan', 'Initials': 'R', 'LastName': 'Saub', 'Affiliation': 'Department of Community Oral Health & Clinical Prevention, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}]","Clinical, cosmetic and investigational dentistry",['10.2147/CCIDE.S248429'] 2659,32581742,"The Association Between Experimentally Induced Stress, Performance Monitoring, and Response Inhibition: An Event-Related Potential (ERP) Analysis.","Psychological stress is increasingly associated with alterations in performance and affect. Yet, the relationship between experimentally induced psychological stress and neural indices of performance monitoring and error processing, as well as response inhibition, are unclear. Using scalp-recorded event-related potentials (ERPs), we tested the relationship between experimental stress, using the Trier Social Stress Test (TSST), and the error-related negativity (ERN), error positivity (Pe), and N2 ERP components. A final sample of 71 undergraduate students were randomly assigned to go through the TSST ( n = 36; 18 female) or a brief mindfulness relaxation exercise ( n = 35; 16 female) immediately followed by a go/no-go task while electroencephalogram (EEG) data were collected. Salivary cortisol, heart rate, and blood pressure confirmed increased physiological stress in the TSST group relative to control. Reaction times, accuracy, and post-error slowing did not differ by stress group. Two-group (TSST, control) by 2-trial type (correct, incorrect for ERN/Pe; go correct, no-go correct for N2) repeated measures ANOVAs for the ERN, Pe, and N2 showed the expected main effects of trial type; neither the ERN nor the N2 ERP components showed interactions with the stress manipulation. In contrast, the Pe component showed a significant Group by Trial interaction, with reduced Pe amplitude following the stress condition relative to control. Pe amplitude did not, however, correlate with cortisol reactivity. Findings suggest a reduction in Pe amplitude following experimental stress that may be associated with reduced error awareness or attention to errors following the TSST. Given the variability in the extant literature on the relationship between experimentally induced stress and neurophysiological reflections of performance monitoring, we provide another point of data and conclude that better understanding of moderating variables is needed followed by high-powered replication studies to get at the nuance that is not yet understood in the relationship between induced stress and performance monitoring/response inhibition processes.",2020,"Reaction times, accuracy, and post-error slowing did not differ by stress group.",['71 undergraduate students'],"['TSST', 'brief mindfulness relaxation exercise ( n = 35; 16 female) immediately followed by a go/no-go task while electroencephalogram (EEG) data were collected']","['Salivary cortisol, heart rate, and blood pressure confirmed increased physiological stress', 'Pe amplitude', 'Trier Social Stress Test (TSST), and the error-related negativity (ERN), error positivity (Pe), and N2 ERP components', 'cortisol reactivity', 'Reaction times, accuracy, and post-error slowing']","[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]",71.0,0.0480349,"Reaction times, accuracy, and post-error slowing did not differ by stress group.","[{'ForeName': 'Rebekah E', 'Initials': 'RE', 'LastName': 'Rodeback', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Hedges-Muncy', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States.'}, {'ForeName': 'Isaac J', 'Initials': 'IJ', 'LastName': 'Hunt', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States.'}, {'ForeName': 'Kaylie A', 'Initials': 'KA', 'LastName': 'Carbine', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Steffen', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Larson', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, United States.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00189'] 2660,32581766,Telmisartan and Rosuvastatin Synergistically Ameliorate Dementia and Cognitive Impairment in Older Hypertensive Patients With Apolipoprotein E Genotype.,"Objective : To investigate the effect of telmisartan, rosuvastatin, or their combination on dementia and to understand the impact of apolipoprotein E ( APOE ) genotype on the effect of the medications in older patients with hypertension. Methods : This is a double-blind, randomized, and placebo-controlled trial using a 2 × 2 factorial design. Between April 2008 and November 2010, 1,244 hypertensive patients aged ≥60 years without cognitive impairment were recruited from communities in six cities in Shandong area, China. Patients were randomized into telmisartan and rosuvastatin administration after a 2-week washout period. APOE genotype was identified at the baseline. Possible dementia was determined using the combination of the global cognitive function and Assessment of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Results : Over an average follow-up of 7 [interquartile range (IQR): 6.7-7.2] years, telmisartan and rosuvastatin significantly reduced the cognitive impairment progression and the incidence of dementia. There was a synergistic interaction between telmisartan and rosuvastatin to reduce the cognitive impairment and the incidence of dementia ( P adjusted < 0.001). The cognitive impairment progression and the risk of dementia were higher in the hypertensive patients with APOE ε4 allele than in those without APOE ε4 allele. Rosuvastatin medication significantly alleviated the cognitive impairment progression and the risks of dementia in patients with APOE ε4 allele. Conclusion : The combination of telmisartan and rosuvastatin might be an effective prevention and/or treatment strategy for cognitive impairment and dementia, especially in hypertensive patients with the APOE ε4 allele. Clinical Trial Registration: www.ClinicalTrials.gov, ChiCTR.org.cn, identifier ChiCTR-IOR-17013557. Registered on April 12, 2017 - Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=23121.",2020,The cognitive impairment progression and the risk of dementia were higher in the hypertensive patients with APOE,"['Older Hypertensive Patients', 'older patients with hypertension', 'hypertensive patients with APOE', 'hypertensive patients with the APOE', 'Between April 2008 and November 2010, 1,244 hypertensive patients aged ≥60 years without cognitive impairment were recruited from communities in six cities in Shandong area, China']","['Telmisartan and Rosuvastatin', 'apolipoprotein E ( APOE ) genotype', 'Rosuvastatin medication', 'telmisartan, rosuvastatin', 'telmisartan and rosuvastatin', 'placebo']","['cognitive impairment progression and the incidence of dementia', 'cognitive impairment progression and the risks of dementia', 'cognitive impairment and the incidence of dementia', 'Dementia and Cognitive Impairment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1244.0,0.0294624,The cognitive impairment progression and the risk of dementia were higher in the hypertensive patients with APOE,"[{'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Institute of Basic Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Medicine and Life Sciences, University of Jinan-Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Yingxin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Institute of Basic Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Yuanli', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Community, Lanshan District People Hospital, Linyi, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Shangwen', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Institute of Basic Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'The Russel H. Morgan Department of Radiology and Radiological Sciences, The Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Basic Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chai', 'Affiliation': 'Institute of Basic Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.00154'] 2661,32472263,"Functional outcome after corrective osteotomy for malunion of the distal radius: a randomised, controlled, double-blind trial.","PURPOSE The purpose of this randomised, controlled, double-blind trial was to evaluate functional outcome during the first year after corrective osteotomy for malunited distal radius fractures, with or without filling the osteotomy void. METHOD Patients were randomised to receive a HydroSet bone substitute or no graft. Cortical contact was maintained and stabilisation of the osteotomy was carried out with a DiPhos R- or RM Plate. To evaluate subjective functional outcome, the Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Q-DASH), the Canadian Occupational Performance Measure (COPM) and the RAND-36 were used. Moreover, range of motion and grip strength were measured by blinded evaluators. Evaluations were made pre-operatively and three, six and 12 months post-operatively. RESULTS There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05). In both groups, there was a significant improvement at the 12-month follow-up compared with pre-operatively for the PRWE, the Q-DASH and the COPM satisfaction scores. The RAND-36 revealed no significant differences except for two domains, in which there was an improvement in the treatment group (p < 0.05). For grip strength and for range of motion in all movement directions, except dorsal extension, there was a significant improvement in both groups (p < 0.05). CONCLUSION There is no significant difference in functional outcome during the first year after corrective open-wedge distal radius osteotomy, where cortical contact is maintained, regardless of whether or not bone substitute to fill the void is used.",2020,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"['malunion of the distal radius', 'Patients']","['HydroSet bone substitute or no graft', 'corrective osteotomy']","['range of motion or grip strength', 'functional outcome', 'Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire ', 'range of motion and grip strength', 'COPM satisfaction scores', 'Canadian Occupational Performance Measure (COPM']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}]",,0.070651,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Andreasson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Ingrid.f.andreasson@vgregion.se.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Kjellby-Wendt', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Fagevik Olsén', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Aurell', 'Affiliation': 'Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ullman', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jón', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",International orthopaedics,['10.1007/s00264-020-04605-x'] 2662,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities. METHODS Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response. RESULTS We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus. LIMITATIONS Only young Chinese males without any trauma experience were recruited in this study. CONCLUSIONS The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123'] 2663,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults. METHODS Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual. RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)]. DISCUSSION The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054'] 2664,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD. METHODS Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention. RESULTS The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected. LIMITATIONS The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study. CONCLUSIONS Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007'] 2665,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients. PATIENTS AND METHODS This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24. RESULTS Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG. CONCLUSION Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108'] 2666,32473040,Learning curve of double-guidewire technique by trainees during hands-on endoscopic retrograde cholangiopancreatography training.,"BACKGROUND AND AIMS Double-guidewire technique (DWT) has been successfully performed by experts in difficult biliary cannulation as an advanced technique. This study aimed to define the learning curve and safety of DWT by trainees during hands-on endoscopic retrograde cholangiopancreatography (ERCP) training. METHODS Patients were eligible for inclusion in the study if the biliary cannulation was difficult and the pancreatic duct was inadvertently cannulated. DWT was performed by two trainees randomly under trainers' guidance. The primary outcome was the success rate of DWT biliary cannulation of trainees. Cumulative sum analysis was used to generate visual learning curves. RESULTS A total of 60 patients with difficult cannulation were enrolled. The main indications for ERCP were common bile duct stones (65%) and biliary stricture (31.7%). The learning curve analysis showed that to achieve a 70% rate of successful DWT, 12 procedures were needed for trainee A and 15 for trainee B. Higher targeted success rate of DWT could be achieved if the number of DWT procedures increased. Compared with the early stage of learning DWT (case 1 to 15 for each trainee), trainees had significantly higher DWT success rate in the late stage (36.7% [11/30] vs 80% [24/30], P = 0.001). The final success rate of cannulation was 98.3% (59/60). The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60), respectively. CONCLUSIONS Double-guidewire technique was safely performed by two novel trainees during hands-on ERCP training. Fifteen procedures may be enough for trainees to achieve the competency of performing DWT. (Clinicaltrials.gov number: NCT03707613).",2020,"The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60) respectively. ","['Patients were eligible for inclusion in the study if the biliary cannulation was difficult and the pancreatic duct (PD) was inadvertently cannulated', '60 patients with difficult cannulation were enrolled']","['endoscopic retrograde cholangiopancreatography (ERCP) training', 'Double-guidewire technique (DWT']","['success rate of DWT biliary cannulation of trainees', 'overall rate of post-ERCP pancreatitis and adverse events', 'biliary stricture', 'final success rate of cannulation', 'bile duct stones', 'DWT success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure'}]","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0267869', 'cui_str': 'Calculus of bile duct'}]",60.0,0.0909091,"The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60) respectively. ","[{'ForeName': 'Xiangping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Gui', 'Initials': 'G', 'LastName': 'Ren', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': ""Department of Radiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Shuhui', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Biaoluo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Tao', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Qin', 'Affiliation': ""Department of General Surgery, First Affiliated Hospital of Xian Jiaotong University, Xi'an, China.""}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Farrell', 'Affiliation': 'Department of Digestive Disease and Yale Center for Pancreatic Disease, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Xuegang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kaichun', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yanglin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15120'] 2667,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion. OBJECTIVES The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population. METHODS A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline. RESULTS During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters. CONCLUSION These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983'] 2668,32473046,"A randomized, controlled trial comparing the immunogenecity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipients.","BACKGROUND The risk of invasive pneumococcal disease is significant among solid organ transplant (SOT) recipients. The optimal pneumococcal vaccination strategy for SOT patients is not known. METHODS The potential kidney transplant recipients in dialysis were randomized into two arms: to receive a 23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13) before transplantation and a second dose of PCV13 six months after the transplantation. Serotype-specific antibody concentrations and opsonophagocytic activity (OPA) were measured before and after the first vaccination (visits V1,V2) and six and seven months after the transplantation, for example, before and after the second PCV13 (visits V3,V4). RESULTS Out of 133 participants, 48 (PCV13 arm) and 46 (PPV23 arm) received a kidney transplant, and 37 + 37 in both arms completed the study. After the first vaccination, the geometric mean concentrations (GMCs) in the PCV13 arm were significantly higher for 9/13 serotypes and the OPA geometric mean titers (GMTs) were significantly higher for 4/13 serotypes. At V3, the antibody levels had declined but OPA remained significantly higher for 7/13 (PCV13) vs 4/13 (PPV23) serotypes. At V4, the GMCs for 9/13 serotypes and the GMTs for 12/13 serotypes were significantly higher in the PCV13 arm. The GMCs but not GMTs were lower than at V2. There was no difference in adverse effects. No vaccine-related allograft rejection was detected. CONCLUSIONS The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe.",2020,"The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe .","['kidney transplant recipients in dialysis', 'Out of 133 participants, 48 (PCV13 arm) and 46 (PPV23 arm) received a kidney transplant, and 37 + 37 in both arms completed the study', 'kidney transplant recipients', 'solid organ transplant (SOT) recipients', 'SOT patients']","['23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13', '23-valent pneumococcal polysaccharide vaccination']","['geometric mean concentrations (GMCs', 'allograft rejection', 'immunogenicity of PCV13', 'OPA', 'adverse effects', 'antibody levels', 'OPA geometric mean titres (GMTs', 'Serotype-specific antibody concentrations and opsonophagocytic activity (OPA']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0961101', 'cui_str': '23-valent pneumococcal capsular polysaccharide vaccine'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]",133.0,0.0617085,"The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe .","[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases of Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Käyhty', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Saha', 'Affiliation': 'Division of Nephrology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Lahdenkari', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Koskinen', 'Affiliation': 'HUH Abdominal Center, Division of Nephrology, Helsinki University Hospital and Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'HUH Abdominal Center, Division of Liver Diseases and Transplantation, Helsinki University Hospital and Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'HUH Inflammation Center, Division of Infectious Diseases of Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}]",Transplant infectious disease : an official journal of the Transplantation Society,['10.1111/tid.13343'] 2669,32580980,Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-experimental trial.,"INTRODUCTION Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease in the Spanish population. Typically, T2DM is associated with other chronic conditions. Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications. However, it has not yet been demonstrated that a comprehensive and intensive health education protocol at the time of diagnosis has the benefits described previously. Currently, there is great variability in the practices of primary care nurses regarding health education at the time of disease diagnosis.We aimed to evaluate the effectiveness of a systematic protocol with a comprehensive care programme in people with newly diagnosed T2DM with associated comorbidities. METHODS AND ANALYSIS A multicentre quasi-experimental design comparing a group of individuals taking part in the intervention (intervention group (IG)) with a similar group receiving standard diabetes care (comparison group (CG)) is planned. The intervention will take place during the 3 months after study enrolment. Data will be collected at baseline and at 3, 6 and 12 months. Ten primary care centres in Barcelona city will be selected for participation: 5 for the IG and 5 for the CG. The IG will include five structured individual visits postdiagnosis with the primary care nurse, during which aspects of diabetes education will be discussed with the patient and his/her family. The results will be measured in terms of health-related quality of life and the change in main outcomes (glycated haemoglobin and weight). ETHICS AND DISSEMINATION The study fully met the requirements of the Ethical Committee of Clinical Investigation of the IDIAP Jordi Gol (approval code: P13/118). Patients will be informed that their data are confidential, and they have the right to withdraw at any time without penalty. Dissemination will include publishing the findings in peer-reviewed journals and sharing our findings at scientific conferences. TRIAL REGISTRATION NUMBER NCT03990857; Pre-results.",2020,"Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications.","['people with newly diagnosed T2DM with associated comorbidities', 'patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care', 'Ten primary care centres in Barcelona city will be selected for participation: 5 for the IG and 5 for the CG']","['comprehensive care protocol', 'systematic protocol with a comprehensive care programme', 'intervention (intervention group (IG)) with a similar group receiving standard diabetes care (comparison group (CG']","['cardiovascular risk, improving glycaemic control and preventing T2DM complications']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0609571,"Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Lapena', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain clapena@gencat.cat.""}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Borràs', 'Affiliation': 'Gerència Territorial de Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Clarisa', 'Initials': 'C', 'LastName': 'Digon', 'Affiliation': ""Centre d'Atenció Primària Sagrera, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Aznar', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Del Val Garcia', 'Affiliation': 'Unitat de Suport a la Recerca Barcelona Ciutat, Fundació Institut Universitari per a la recerca en Atenció Primària de Salut Jordi Gol i Gurina (IDIAP Jordi Gol), Barcelona, Spain.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Castelblanco', 'Affiliation': ""DAP-Cat Group, Unitat de Suport a la Recerca Barcelona, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garaikoetxea', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Vicencia', 'Initials': 'V', 'LastName': 'Laguna', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}]",BMJ open,['10.1136/bmjopen-2019-033725'] 2670,32580979,Validation of the Transition Readiness and Appropriateness Measure (TRAM) for the Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare in Europe (MILESTONE) study.,"OBJECTIVE Young people moving from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS) are faced with significant challenges. To improve this state of affairs, there needs to be a recognition of the problem and initiatives and an urgent requirement for appropriate tools for measuring readiness and outcomes at the transfer boundary (16-18 years of age in Europe). The objective of this study was to develop and validate the Transition Readiness and Appropriateness Measure (TRAM) for assessing a young person's readiness for transition, and their outcomes at the transfer boundary. DESIGN MILESTONE prospective study. SETTING Eight European Union (EU) countries participating in the EU-funded MILESTONE study. PARTICIPANTS The first phase (MILESTONE validation study) involved 100 adolescents (pre-transition), young adults (post-transition), parents/carers and both CAMHS and AMHS clinicians. The second phase (MILESTONE cohort study and nested cluster randomised trial) involved over 1000 young people. RESULTS The development of the TRAM began with a literature review on transitioning and a review of important items regarding transition by a panel of 34 mental health experts. A list of 64 items of potential importance were identified, which together comprised the TRAM. The psychometric properties of the different versions of the TRAM were evaluated and showed that the TRAM had good reliability for all versions and low-to-moderate correlations when compared with other established instruments and a well-defined factor structure. The main results of the cohort study with the nested cluster randomised trial are not reported. CONCLUSION The TRAM is a reliable instrument for assessing transition readiness and appropriateness. It highlighted the barriers to a successful transition and informed clinicians, identifying areas which clinicians on both sides of the transfer boundary can work on to ease the transition for the young person. TRIAL REGISTRATION NUMBER ISRCTN83240263 (Registered 23 July 2015), NCT03013595 (Registered 6 January 2017); Pre-results.",2020,The psychometric properties of the different versions of the TRAM were evaluated and showed that the TRAM had good reliability for all versions and low-to-moderate correlations when compared with other established instruments and a well-defined factor structure.,"['100 adolescents (pre-transition), young adults (post-transition), parents/carers and both CAMHS and AMHS clinicians', '1000 young people', 'Eight European Union (EU) countries participating in the EU-funded MILESTONE study', 'Young people moving from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS']",['Transition Readiness and Appropriateness Measure (TRAM'],['Transition Readiness and Appropriateness Measure (TRAM'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1269909', 'cui_str': 'MOVED FROM'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0486327,The psychometric properties of the different versions of the TRAM were evaluated and showed that the TRAM had good reliability for all versions and low-to-moderate correlations when compared with other established instruments and a well-defined factor structure.,"[{'ForeName': 'Paramala', 'Initials': 'P', 'LastName': 'Santosh', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK paramala.1.santosh@kcl.ac.uk.""}, {'ForeName': 'Jatinder', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Adams', 'Affiliation': 'School of Psychology, University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Mastroianni', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Heaney', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lievesley', 'Affiliation': 'HealthTracker, Gillingham, UK.'}, {'ForeName': 'Ilyas', 'Initials': 'I', 'LastName': 'Sagar-Ouriaghli', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Allibrio', 'Affiliation': 'Unit of Neuropsychiatry, ASST Spedali Civili di Brescia Dipartimento di Salute Mentale, Brescia, Lombardia, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Davidović', 'Affiliation': 'Department of Psychiatry, Clinical Hospital Center Split, Split, Croatia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Girolamo', 'Affiliation': 'Psychiatric Epidemiology and Evaluation Unit, Saint John of God Clinical Research Center, Brescia, Italy.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Dieleman', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Dodig-Ćurković', 'Affiliation': 'Department of Pediatric and Adolescent Psychiatry, KBC Osijek, Osijek, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Franić', 'Affiliation': 'Department of Psychiatry, Clinical Hospital Center Split, Split, Croatia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gatherer', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gheza', 'Affiliation': 'Neuropsychiatry Service of Childhood and Adolescence, Mental Health Department, ASST della Valcamonica, Breno, Lombardia, Italy.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, Coventry, UK.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Manenti', 'Affiliation': 'Unit of Neuropsychiatry, ASST Spedali Civili di Brescia Dipartimento di Salute Mentale, Brescia, Lombardia, Italy.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Margari', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Puglia, Italy.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McNicholas', 'Affiliation': 'School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pastore', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Puglia, Italy.'}, {'ForeName': 'Moli', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Purper-Ouakil', 'Affiliation': 'Psychological Medicine for Children and Adolescents, Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Neuropsychiatry Service of Childhood and Adolescence, Mental Health Department, ASST della Valcamonica, Breno, Lombardia, Italy.'}, {'ForeName': 'Vehbi', 'Initials': 'V', 'LastName': 'Sakar', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychotherapy, Universitatsklinikum Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schulze', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychotherapy, Universitatsklinikum Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Signorini', 'Affiliation': 'Psychiatric Epidemiology and Evaluation Unit, Saint John of God Clinical Research Center, Brescia, Italy.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Street', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Tah', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tremmery', 'Affiliation': 'Department of Neurosciences, Child & Adolescent Psychiatry, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Tuffrey', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Tuomainen', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Verhulst', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, Coventry, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Wolke', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Fiori', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Swaran', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033324'] 2671,32580984,Occupational therapist-led mindfulness-based stress reduction for older adults living with subjective cognitive decline or mild cognitive impairment in primary care: a feasibility randomised control trial protocol.,"INTRODUCTION Community-dwelling older adults living with subjective cognitive decline or mild cognitive impairment may experience decreased efficiency in their overall functional performance. This decreased cognitive efficiency may result in anxiety, low mood, perceived stress and decreased emotional well-being and quality-of-life. These psychological symptoms may further exacerbate cognitive decline.Exploring non-pharmacological interventions such as mindfulness within primary care is vital in enabling individuals to develop strategies to manage cognitive impairment or psychological symptoms. Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated. The primary objective of this study is to explore the feasibility of conducting a randomised controlled trial of an occupational therapist-led MBSR programme within primary care. METHODS Convergent mixed-methods, randomised control feasibility trial with 40 participants from an interprofessional primary care team in Toronto, Ontario. Participants are randomised into the 8-week MBSR group or wait-list control will be compared at baseline, postintervention and 4weeks follow-up. The primary aim is to determine the feasibility of the intervention with this population and setting. The secondary aim is to examine perceived satisfaction with functional performance as measured by the Canadian Occupational Performance Measure. Secondary clinical outcomes include psychological symptoms. ANALYSIS Investigators will analyse the quantitative and qualitative data strands separately. Descriptive statistics, focus group and interviews will then be merged and further analysed to best understand the feasibility and preliminary clinical outcomes from the study. ETHICS AND DISSEMINATION The study is approved by Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418). The study will follow Standard Protocol Items: Recommendations for Interventional Trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. Trial registration number NCT03867474; Pre-results.",2020,"Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated.","['Community-dwelling older adults living with subjective cognitive decline or mild cognitive impairment', ""Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418"", 'older adults living with subjective cognitive decline or mild cognitive impairment in primary care', '40 participants from an interprofessional primary care team in Toronto, Ontario']","['Mindfulness-based stress reduction (MBSR', 'MBSR group or wait-list control', 'occupational therapist-led MBSR programme', 'Occupational therapist-led mindfulness-based stress reduction']","['cognitive efficiency', 'psychological symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",40.0,0.109064,"Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated.","[{'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': ""Family Practice, Women's College Hospital, Toronto, Ontario, Canada Todd.tran@wchospital.ca.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Donnelly', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}, {'ForeName': 'Emily Joan', 'Initials': 'EJ', 'LastName': 'Nalder', 'Affiliation': 'Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Trothen', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-035299'] 2672,32476255,"Effects of dipeptidyl peptidase-4 inhibitor linagliptin versus sulphonylurea glimepiride on systemic haemodynamics in overweight patients with type 2 diabetes: A secondary analysis of an 8-week, randomized, controlled, double-blind trial.","AIM To determine the glucose-independent effect of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin versus the sulphonylurea glimepiride on systemic haemodynamics in the fasting and postprandial state in patients with type 2 diabetes (T2D). MATERIALS AND METHODS In this prespecified secondary analysis of a phase IV, double-blind trial, 46 metformin-treated, overweight patients with T2D were included and randomly assigned (1:1) to once-daily linagliptin (5 mg) or glimepiride (1 mg) for 8 weeks. In a sub-study involving 26 patients, systemic haemodynamics were also assessed following a standardized liquid meal (Nutridrink Yoghurt style). Systemic haemodynamics (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry) and cardiac sympathovagal balance (heart rate variability [HRV]) were measured in the fasting state and repetitively following the meal. Ewing tests were performed in the fasting state. RESULTS From baseline to week 8, linagliptin compared with glimepiride did not affect systemic haemodynamics, arterial stiffness or HRV in the fasting state. Linagliptin increased parasympathetic nervous activity, as measured by the Valsalva manoeuvre (P = .021) and deep breathing test (P = .027) compared with glimepiride. Postprandially, systolic blood pressure (SBP) dropped an average of 7.6 ± 1.6 mmHg. Linagliptin reduced this decrease to 0.7 ± 2.3 mmHg, which was significant to glimepiride (P = .010). CONCLUSIONS When compared with glimepiride, linagliptin does not affect fasting blood pressure. However, linagliptin blunted the postprandial drop in SBP, which could benefit patients with postprandial hypotension.",2020,"RESULTS From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","['46 metformin-treated, overweight T2DM patients', 'overweight patient with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM']","['Linagliptin', 'glimepiride, linagliptin', 'sulfonylurea glimepiride', 'dipeptidyl peptidase (DPP)-4 inhibitor linagliptin', 'glimepiride', 'DPP-4 inhibitor linagliptin', 'linagliptin']","['systemic hemodynamics, arterial stiffness or HRV', 'systemic hemodynamics', 'fasting blood pressure', 'parasympathetic nervous activity', 'Systemic haemodynamic (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry), and cardiac sympathovagal balance (heart rate variability; HRV', 'Valsalva-manoeuvre', 'systemic haemodynamics']","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}]",26.0,0.102531,"RESULTS From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Kraaijenhof', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'D Margriet', 'Initials': 'DM', 'LastName': 'Ouwens', 'Affiliation': 'German Diabetes Center (DDZ), Leibniz Center for Diabetes Research, Heinrich Heine University, Medical Faculty, Düsseldorf, Germany.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14107'] 2673,32582343,"Comparing between the effect of energy-restricted diet and yoga on the resting metabolic rate, anthropometric indices, and serum adipokine levels in overweight and obese staff women.","Background Weight management is an important strategy to prevent the consequences of obesity. The aim of the study was to compare the effect of yoga practice and energy-restricted diet on resting metabolic rate (RMR), anthropometric indices, and serum adiponectin and leptin in overweight and obese women. Materials and Methods Obese or overweight women were divided into two groups: yoga practicing and energy-restricted diet. Exercise trials consisted of 60-min Hatha yoga equal to 200 kilocalories (kcal) combined with 300 kcal restriction per day, and an energy-restricted diet consisted of 500 kcal restriction per day. The intervention period for both the groups was 8 weeks. RMR, anthropometric indices, and serum adiponectin, leptin, and lipid profiles were measured at baseline and at the end of the study. Results RMR was increased in yoga but not in the diet group ( P = 0.001). The level of adiponectin was increased in the yoga group compared with the diet ( P = 0.035). The concentration of high-density lipoprotein-cholesterol was decreased in the diet group significantly but not in yoga ( P = 0.006). The level of leptin was decreased in both the groups ( P = 0.001), and there were no significant differences between the two groups. Conclusion The findings of the study demonstrated the effect of yoga practicing on RMR, and serum adiponectin, in overweight and obese women. It seems yoga practice with less energy restriction compared with a common energy restriction diet and is more effective in weight management for those who are in weight loss programs.",2020,The level of adiponectin was increased in the yoga group compared with the diet ( P = 0.035).,"['Materials and Methods\n\n\nObese or overweight women', 'overweight and obese women', 'overweight and obese staff women']","['energy-restricted diet and yoga', '60-min Hatha yoga equal to 200 kilocalories (kcal) combined with 300 kcal restriction per day, and an energy-restricted diet consisted of 500 kcal restriction per day', 'yoga practicing and energy-restricted diet', 'yoga practice and energy-restricted diet']","['level of leptin', 'RMR, and serum adiponectin', 'RMR', 'level of adiponectin', 'concentration of high-density lipoprotein-cholesterol', 'resting metabolic rate, anthropometric indices, and serum adipokine levels', 'RMR, anthropometric indices, and serum adiponectin, leptin, and lipid profiles', 'resting metabolic rate (RMR), anthropometric indices, and serum adiponectin and leptin']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",500.0,0.0224718,The level of adiponectin was increased in the yoga group compared with the diet ( P = 0.035).,"[{'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Yazdanparast', 'Affiliation': 'Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jafarirad', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Borazjani', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Department of Biostatistics, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Jahanshahi', 'Affiliation': 'Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_787_19'] 2674,32582353,Vitamin E in the prevention of vancomycin-induced nephrotoxicity.,"Background and purpose The use of vancomycin, as a key therapeutic choice for treatment of hazardous infections, may be associated with nephrotoxicity. The proposed mechanism is the indirect production of reactive oxygen species and oxidative stress. The purpose of this study was to investigate the effect of vitamin E as an antioxidant agent in the prevention of vancomycin-induced nephrotoxicity. Experimental approach In a matched-groups interventional study, patients who received vancomycin for any indication were assigned to vitamin E ( n = 30) and control ( n = 60) groups. The patients in experimental group received 400 units of oral vitamin E per day for 10 days started concurrently with vancomycin, while the patients in control group received vancomycin alone. Serum level of creatinine, blood urea nitrogen (BUN), creatinine clearance (CrCl), and 24-h urine output were determined and recorded before the start of interventions, every other day during therapy, and 12 h after the last dose of vancomycin in 10 th day of therapy for all patients. Also, the rate of acute kidney injury (AKI) in the two groups was recorded. Finally, the mean values of the measured parameters were compared between the groups. Findings / Results Treatment with vitamin E for 10 days resulted in a significant reduction of BUN (from 17.5 ± 7.8 mg/dL at baseline to 11.4 ± 4.8 mg/dL at the end; P < 0.001) along with slightly non-significant increase of CrCl (from 84.7 ± 18.9 mL/min at baseline to 91.3 ± 19.5 mL/min at the end; P = 0.301) in comparison to the control group. However, CrCl decreased significantly in the control group. Vitamin E had no significant effect on 24-h urine output. Regarding vancomycin-induced AKI, 12 cases were observed in the control group, while no case was reported in experimental group ( P = 0.041). Conclusion and implications This study showed the beneficial effect of add-on therapy of vitamin E besides vancomycin in reducing AKI, which could be considered as a new potential prophylactic therapy for vancomycin-induced nephrotoxicity.",2020,Vitamin E had no significant effect on 24-h urine output.,[],"['vancomycin alone', 'vancomycin', 'vitamin E', '400 units of oral vitamin E', 'vitamin E besides vancomycin', 'Vitamin E']","['Serum level of creatinine, blood urea nitrogen (BUN), creatinine clearance (CrCl), and 24-h urine output', 'rate of acute kidney injury (AKI', 'CrCl', '24-h urine output', 'BUN']",[],"[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",12.0,0.052825,Vitamin E had no significant effect on 24-h urine output.,"[{'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Soltani', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, I.R. Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, I.R. Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Meidani', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, I.R. Iran.'}, {'ForeName': 'Shirinsadat', 'Initials': 'S', 'LastName': 'Badri', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, I.R. Iran.'}, {'ForeName': 'Sajedeh', 'Initials': 'S', 'LastName': 'Alaei', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, I.R. Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, I.R. Iran.'}]",Research in pharmaceutical sciences,['10.4103/1735-5362.283813'] 2675,32582363,"Effect of toxic trace element detoxification, body fat reduction following four-week intake of the Wellnessup diet: a three-arm, randomized clinical trial.","Background Detox diet are known as a popular dieting strategies that helps toxins elimination and weight manage but there is very little clinical evidence. The Wellnessup diet (WD) used in the present study designed as a healthy meals based on organic plant based diets including various vegetables, fruits, whole grains, nuts and phytonutrients. Methods To evaluate the effects of 4 week intake of the WD on toxic trace element detoxification, body fat reduction, and safety parameters. Forty-five women with body mass index (BMI) of 23.5-30 kg/m 2 were recruited. Thirty of them were assigned 1:1 to the test group (WD, 15 subjects) and control group 1 (calorie-restricted diet, CRD, 15 subjects) in a single blind and randomized, and the remaining 15 subjects were assigned to control group 2 (maintaining regular diet, MRD). The primary outcome were toxic trace element levels in hair (29 types of heavy metals), and the secondary outcomes were changes in anthropometric and urinary organic acids. Results The levels of four toxic trace elements in hair decreased in the WD group after the diet compared to before the diet. Ni, Rh, Sn, and Ga were significantly lower in the WD group than in the CRD or MRD group ( p  < 0.05). At the end of the trial, both WD and CRD groups had lower BMI, Waist Circumference(WC), Hip Circumference(HC) and WHR compared to the baseline values ( p  < 0.05). Compared to the WD group, the CRD group had a greater mean change ( p  < 0.05) from the baseline for weight loss (- 3.22 ± 0.48 kg vs - 1.88 ± 0.95 kg vs) and fat free mass (- 2.08 kg vs - 1.09 kg). The weight, BMI, body fat mass, fat free mass, WC, and HC of the CRD group were significantly decreased compared to the MRD ( p  < 0.05). No significant changes in any safety parameter were observed. Conclusions Use of WD might have several beneficial effects and safety such as body fat reduction and improving some the element detoxification through caloric restriction but did not reducing body fat mass more than calorie-restricted diet. Trial registration This study was registered at Clinical Research Information Service (CRIS) of Republic of Korea (KCT0003002).",2020,"Ni, Rh, Sn, and Ga were significantly lower in the WD group than in the CRD or MRD group ( p  < 0.05).","['four-week intake of the Wellnessup diet', 'Forty-five women with body mass index (BMI) of 23.5-30\u2009kg/m 2 were recruited']","['control group 2 (maintaining regular diet, MRD', 'toxic trace element detoxification', 'control group 1 (calorie-restricted diet, CRD', 'CRD', 'healthy meals based on organic plant based diets including various vegetables, fruits, whole grains, nuts and phytonutrients']","['changes in anthropometric and urinary organic acids', 'Ni, Rh, Sn, and Ga', 'toxic trace element detoxification, body fat reduction, and safety parameters', 'fat free mass', 'weight loss', 'safety parameter', 'toxic trace element levels in hair (29 types of heavy metals', 'lower BMI, Waist Circumference(WC), Hip Circumference(HC) and WHR', 'levels of four toxic trace elements in hair', 'weight, BMI, body fat mass, fat free mass, WC, and HC']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5197846', 'cui_str': 'Diet, Plant-Based'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0577749', 'cui_str': 'Phytochemical'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0369760', 'cui_str': 'Organic acid'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428570', 'cui_str': 'Trace element measurement'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0347988', 'cui_str': 'Heavy metal'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",45.0,0.0417829,"Ni, Rh, Sn, and Ga were significantly lower in the WD group than in the CRD or MRD group ( p  < 0.05).","[{'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907 South Korea.'}, {'ForeName': 'Woo-Lim', 'Initials': 'WL', 'LastName': 'Kim', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907 South Korea.'}, {'ForeName': 'Byung-Hyun', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': 'Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907 South Korea.'}, {'ForeName': 'Seung-Ok', 'Initials': 'SO', 'LastName': 'Lee', 'Affiliation': 'Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907 South Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907 South Korea.'}]",Nutrition & metabolism,['10.1186/s12986-020-00465-9'] 2676,32582585,Benefits of Exercise Training for Children and Adolescents Undergoing Cancer Treatment: Results From the Randomized Controlled MUCKI Trial.,"Objective: In cancer patients, the impairment in muscle function is a frequently observed phenomenon. However, comprehensive evaluation of the effect of exercise training on muscle function in childhood cancer patients (CCPs) is sparse and therefore investigated in the MUCKI trial. Study Design: In the randomized controlled MUCKI trial, CCPs during intensive cancer treatment and aged 4-18 years were recruited. Eligible patients were enrolled soon after diagnosis as long as they were physically and mentally able to participate in exercise testing and training. Patients of the exercise group ( n = 16) participated in average 2.7 ± 1.2 times per week in a combined resistance and endurance training with moderate exercise intensity, for a time period of 8.0 ± 2.1 weeks, while patients of the control group ( n = 17) received usual care. Leg strength was evaluated as the primary endpoint. Secondary endpoints were 6-min walk performance, arm strength, body composition, fatigue, and health-related quality of life. Results: Comparisons of pre- and post-intervention results were evaluated by baseline and stratification criteria adjusted analysis and showed positive effects for the exercise group regarding leg strength [ F (1, 20) = 5.733; p = 0.027 * ; η p 2 = 0.223], walking performance [ F (1, 25) = 4.270; p = 0.049 * ; η p 2 = 0.146], fatigue [ F (1, 13) = 8.353; p = 0.013 * ; η p 2 = 0.391], self-esteem [ F (1, 6) = 6.823; p = 0.040 * ; η p 2 = 0.532], and self-reported strength and endurance capacity [ F (1, 6) = 6.273; p = 0.046 * ; η p 2 = 0.511]. No significant differences were found for the other parameters. Conclusion: Within one of the first randomized controlled trials, the present study provides evidence for a positive effect of combined training in CCPs during intensive cancer treatment. Further research is needed to confirm these results and to evaluate their clinical impact. Clinical Trial Registration Number: NCT02612025.",2020,No significant differences were found for the other parameters. ,"['childhood cancer patients (CCPs', 'Children and Adolescents Undergoing Cancer Treatment', 'Eligible patients were enrolled soon after diagnosis as long as they were physically and mentally able to participate in exercise testing and training', 'during intensive cancer treatment and aged 4-18 years were recruited']","['exercise training', 'usual care', 'CCPs', 'combined resistance and endurance training with moderate exercise intensity', 'Exercise Training']","['Leg strength', 'fatigue [ F', 'muscle function', 'leg strength', 'self-esteem', 'walking performance [ F (1, 25) = 4.270', 'self-reported strength and endurance capacity [ F', '6-min walk performance, arm strength, body composition, fatigue, and health-related quality of life']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.143708,No significant differences were found for the other parameters. ,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stössel', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Neu', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Wingerter', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Institute of Sport and Sport Science, Technical University of Dortmund, Dortmund, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Khalifa El', 'Initials': 'KE', 'LastName': 'Malki', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Freerk T', 'Initials': 'FT', 'LastName': 'Baumann', 'Affiliation': 'Department I of Internal Medicine, Center of Integrated Oncology Köln Bonn, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Henninger', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Lehmann', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Otto', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Childhood Cancer Center, University Medical Center Mainz, Mainz, Germany.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00243'] 2677,32582595,Effects of Early Intervention on Visual Function in Preterm Infants: A Randomized Controlled Trial.,"Objectives: To determine the effectiveness of an early intervention program in enhancing visual function in very preterm infants. Methods: We conducted a RCT. We included preterm infants born between 25 +0 and 29 +6 weeks of gestational age (GA), without severe morbidities, and their families. Infants were randomized to either receive Standard Care (SC) or Early Intervention (EI). SC, according to NICU protocols, included Kangaroo Mother Care and minimal handling. EI included, in addition to routine care, parental training according to the PremieStart program, and multisensory stimulation (infant massage and visual interaction) performed by parents. Visual function was assessed at term equivalent age (TEA) using a prevalidated battery evaluating ocular spontaneous motility, ability to fix and follow a target, reaction to color, stripes discrimination and visual attention at distance. Results: Seventy preterm (EI n = 34, SC n = 36) infants were enrolled. Thirteen were excluded according to protocol. Fifty-seven infants (EI = 27, SC = 30) were assessed at TEA. The two groups were comparable for parental and infant characteristics. In total, 59% of infants in the EI group achieved the highest score in all the nine assessed items compared to 17% in the SC group ( p = 0.001): all infants in both groups showed complete maturation in four items, but EI infants showed more mature findings in the other five items (ocular motility both spontaneous and with target, tracking arc, stripes discrimination and attention at distance). Conclusions: Our results suggest that EI has a positive effect on visual function maturation in preterm infants at TEA. Trial Registration: clinicalTrial.gov (NCT02983513).",2020,The two groups were comparable for parental and infant characteristics.,"['very preterm infants', 'Results: Seventy preterm (EI n = 34, SC n = 36) infants were enrolled', 'preterm infants at TEA', 'Preterm Infants', 'Fifty-seven infants (EI = 27, SC = 30) were assessed at TEA', 'preterm infants born between 25 +0 and 29 +6 weeks of gestational age (GA), without severe morbidities, and their families']","['Early Intervention', 'early intervention program', 'Standard Care (SC) or Early Intervention (EI']","['complete maturation', 'Visual Function', 'highest score', 'Visual function', 'five items (ocular motility both spontaneous and with target, tracking arc, stripes discrimination and attention at distance', 'visual function maturation', 'visual function', 'ocular spontaneous motility, ability to fix and follow a target, reaction to color, stripes discrimination and visual attention at distance']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C1532935', 'cui_str': 'Striped'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}]",70.0,0.116693,The two groups were comparable for parental and infant characteristics.,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fontana', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'De Carli', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ricci', 'Affiliation': 'Pediatric Neurology, Department of Human and Child Health and Public Health, Child Health Area, Catholic University UCSC, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Dessimone', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Passera', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pesenti', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonzini', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bassi', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Squarcina', 'Affiliation': ""Department of Neurosciences and Mental Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cinnante', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Neuroradiology Unit, Milan, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fumagalli', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00291'] 2678,32582611,Using Social Marketing to Reduce Salt Intake in Iran.,"Objectives: WHO has recommended that the average salt intake must be <5 grams per day. However, people consume salt much more in many countries. In this study, we design and implement an intervention based on social marketing model to reduce salt consumption in Yasuj, Iran. Materials and Methods: This study employed a quasi-experimental pretest-posttest with control group design which consisted of a formative research (qualitative-quantitative) and an interventional phase. To collect the qualitative data, six focus group discussions by participating of 66 people were established. The qualitative data were analyzed manually using directed content analysis. In quantitative study, 166 people aged 25-50 years completed a KAP questionnaire, and their average salt intake was determined through measuring sodium in their urine sample. By analyzing the data, marketing mix components were determined for designing an intervention. An educational package (including posters for installing in the kitchen, pamphlets, phone counseling, four educational classes, and brief interventions done by physicians and other health personnel) focused on reducing salt intake and using alternatives was developed. For one month, program was implemented for intervention group. Two months later, KAP survey and measuring the urine sodium were repeated for intervention and control groups. The data was compared for two groups, before and after the intervention by using independent t-test, paired t-tests and repeated measures ANOVA. Results: The qualitative findings showed that most participants agreed that the salt intake was high in Iran. Most of them recommended home-based and family-driven strategies to reduce salt intake, offered using healthier alternatives for salt, and recognized physicians and health care providers in healthcare facilities as the most important to encourage people to reduce salt intake. After the intervention, the mean and standard deviation of KAP were improved significantly in intervention group. The mean salt intake decreased significantly by 3.01 ± 2.38 in the intervention group and repeated measures ANOVA showed significant change over time ( P < 0.001) and a significant difference between two groups ( P = 0.04) . Also, the interaction between time and group was significant ( P = 0.001). Conclusion: The mean salt intake among the study population was approximately three times more than the level recommended by the WHO. The social marketing-based intervention succeeded in reducing the salt intake of the study subjects by ~3 grams on average.",2020,The mean salt intake decreased significantly by 3.01 ± 2.38 in the intervention group and repeated measures ANOVA showed significant change over time ( P < 0.001) and a significant difference between two groups ( P = 0.04) . ,"['Iran', '166 people aged 25-50 years completed a', 'Yasuj, Iran']","['KAP questionnaire', 'educational package (including posters for installing in the kitchen, pamphlets, phone counseling, four educational classes, and brief interventions done by physicians and other health personnel']","['mean and standard deviation of KAP', 'mean salt intake', 'urine sodium']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine'}]",166.0,0.0123915,The mean salt intake decreased significantly by 3.01 ± 2.38 in the intervention group and repeated measures ANOVA showed significant change over time ( P < 0.001) and a significant difference between two groups ( P = 0.04) . ,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Layeghiasl', 'Affiliation': 'Department of Health Education and Promotion, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Janmohamad', 'Initials': 'J', 'LastName': 'Malekzadeh', 'Affiliation': 'Department of Nutrition, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shams', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Iranian Social Marketing Association, Yasuj University of Medical Sciences, Yasuj, Iran.'}]",Frontiers in public health,['10.3389/fpubh.2020.00207'] 2679,32582758,Exploring Biological Predictive Factors of Progression After Surgery in High-Risk Renal Cell Carcinoma: Results From the French Cohort of the Randomized S-TRAC Trial Patients.,"Objective: We aimed to explore biological predictive factors of progression after surgery in nonmetastatic renal cell carcinoma (RCC) using the collected tumors in the French cohort of the randomized S-TRAC trial patients. Patients and Methods: We analyzed the tumors of the French cohort of STRAC that included 44 cases of clear cell RCC (ccRCC) that were collected from six centers. The main objective was to explore biological predictive factors of progression (defined as PFS) to sunitinib. Broad-spectrum analysis including immunohistochemistry, fluorescent in situ hybridization (FISH), comparative genomic hybridization (CGH) array, and transcriptomic analyses were performed on the tumors. Results: Analysis of vascular density showed type 1 vascular stroma corresponding to high vascular density was associated with progression ( p < 0.034). Loss of poly bromo-1 expression showed a distinct profile: a highly histopathological aggressive tumor with a marked angiogenic profile (vascular endothelial growth factor overexpression and immature vascular stroma type 2), no PD1 or PDL1 expression, and wild-type (WT) status of the VHL gene. There were 27 chromosome regions gained in patients with progression (on chromosomes 7 and 16, and to a lesser extent 8, 12, 17, 17, 19, 20 corresponding to 605 associated genes) and 10 regions lost in these same patients on chromosomes 8 and 9, and to a lesser extent 2 and 21 corresponding to 25 associated genes. Conclusion: We found that an angiogenic phenotype defined by a high vascular density with a vascular type 2 stroma was a predictive factor of sunitinib resistance. Regardless of adjuvant treatment, chromosomal gains and losses and genomic alterations including PBRM1 loss were associated with worse outcomes. Clinical Trial Registration : ClinicalTrials.gov number, NCT00375674.",2020,Analysis of vascular density showed type 1 vascular stroma corresponding to high vascular density was associated with progression ( p < 0.034).,"['nonmetastatic renal cell carcinoma (RCC) using the collected tumors in the French cohort of the randomized S-TRAC trial patients', 'High-Risk Renal Cell Carcinoma', 'tumors of the French cohort of STRAC that included 44 cases of clear cell RCC (ccRCC) that were collected from six centers']",[],"['chromosomal gains and losses and genomic alterations including PBRM1 loss', 'angiogenic profile (vascular endothelial growth factor overexpression and immature vascular stroma type 2), no PD1 or PDL1 expression, and wild-type (WT) status']","[{'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040578', 'cui_str': 'Tracheal structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0008633', 'cui_str': 'Chromosome'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1175582', 'cui_str': 'PBRM1 protein, human'}, {'cui': 'C3267003', 'cui_str': 'Vascular endothelial growth factor overexpression'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.330934,Analysis of vascular density showed type 1 vascular stroma corresponding to high vascular density was associated with progression ( p < 0.034).,"[{'ForeName': 'Idir', 'Initials': 'I', 'LastName': 'Ouzaid', 'Affiliation': 'Department of Pathology, University of Rennes, CHU de Rennes, Rennes, France.'}, {'ForeName': 'Solène Florence', 'Initials': 'SF', 'LastName': 'Kammerer-Jacquet', 'Affiliation': 'Department of Pathology, University of Rennes, CHU de Rennes, Rennes, France.'}, {'ForeName': 'Zineddine', 'Initials': 'Z', 'LastName': 'Khene', 'Affiliation': 'Department of Urology, University of Rennes, CHU de Rennes, Rennes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Patard', 'Affiliation': 'Department of Urology, CH Mont de Marsan, Mont de Marsan, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Bensalah', 'Affiliation': 'Department of Urology, University of Rennes, CHU de Rennes, Rennes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Rioux-Leclercq', 'Affiliation': 'Department of Pathology, University of Rennes, CHU de Rennes, Rennes, France.'}]",Frontiers in surgery,['10.3389/fsurg.2020.00026'] 2680,32582824,Effect of Preoperative Anesthesia Consultation on Decreasing Anxiety in Patients Undergoing Oral and Maxillofacial Surgery.,"Statement of the Problem Preoperative anxiety is the subject of major concern for many patients. Purpose The current study aimed at determining the effect of anesthesia consultation on decreasing anxiety in patients undergoing oral and maxillofacial surgery. Materials and Method This randomized clinical trial was conducted on 250 patients undergoing different maxillofacial surgeries. The data collection instruments included a questionnaire containing the Spielberger state-trait anxiety inventory (STAI) and a researcher-made questionnaire with queries on the demographic characteristics and surgery-related information. Analysis of the data was performed in SPSS, using descriptive and inferential statistics. Results The findings showed that the majority of patients (38.4%) had moderate anxiety; there was no significant difference between the consultation and control groups in terms of age and gender. Also, the scores of state and trait anxiety were significantly lower in the consultation group, compared with the control group. Conclusion The present results showed that preoperative anesthetic consultation reduced preoperative anxiety, compared with the control group. Our findings suggest that anesthetic counseling services should be provided for individuals experiencing high levels of stress.",2020,"Also, the scores of state and trait anxiety were significantly lower in the consultation group, compared with the control group. ","['250 patients undergoing different maxillofacial surgeries', 'Patients Undergoing Oral and Maxillofacial Surgery', 'patients undergoing oral and maxillofacial surgery']","['anesthesia consultation', 'Preoperative Anesthesia Consultation']","['preoperative anxiety', 'questionnaire containing the Spielberger state-trait anxiety inventory (STAI', 'moderate anxiety', 'scores of state and trait anxiety']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}]","[{'cui': 'C1301897', 'cui_str': 'Anesthesia consultation'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0231402', 'cui_str': 'Moderate anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301808', 'cui_str': 'State'}]",250.0,0.0235799,"Also, the scores of state and trait anxiety were significantly lower in the consultation group, compared with the control group. ","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Dental Research Center, Research Institute of Dental Sciences, Dental School, Dept. of Oral and Maxillofacial Surgery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahabaldin', 'Initials': 'S', 'LastName': 'Azizi', 'Affiliation': 'Resident of Oral and Maxillofacial Surgery, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Malek', 'Affiliation': 'Dept. of Anesthesiology, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farinaz', 'Initials': 'F', 'LastName': 'Mahboubi', 'Affiliation': 'Power Electrical Engineer, Tehran University, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Shams', 'Affiliation': 'Oral and Maxillofacial Surgeon, Tehran, Iran.'}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Karimizadeh', 'Affiliation': 'Pediatrician, Khalij Hospital, Bushehr University of Medial Sciences, Bushehr, Iran.'}]","Journal of dentistry (Shiraz, Iran)",['10.30476/DENTJODS.2019.77883.0'] 2681,32582826,"In Vitro Comparative Evaluation of Newly Produced Desensitizer, Chlorhexidine and Gluma on Bond Strength and Bond Longevity of Composite to Dentin.","Statement of the Problem Etching process on dentin can activate matrix metalloproteinase (MMP) which hydrolyze organic matrix of demineralized dentin. Gluma and chlorhexidine could inhibit the activation of MMP. Purpose The aim of the study was to evaluate the effect of a new desensitizing material consisting of Gluma and chlorhexidine together on the shear bond strength and bond durability of composite restorations. Materials and Method One hundred and twenty caries-free extracted premolars were sectioned horizontally from one third of the coronal crown to expose flat dentin surface and randomly divided into 4 groups. In the control group, no surface treatment was used. In the first group chlorhexidine (CHX) 2%, in the second group, new material (NM) and in third group Gluma desensitizer (GD) was applied after etching and before bonding(total-etch bonding system). After the bonding process, the composite was placed on the surface of the samples using a cylindrical mold. Then, the shear bond strengths of half of the specimens were measured after 24 hours and the other half after 6 months of storage in distilled water and thermocycling. The failure types of specimens were evaluated with a stereomicroscope. Data were analyzed using One-way Anova and Tukey's Post Hoc tests in SPSS software. Results After 6 months, the bond strength decreased in all groups and differences were statistically significant ( p = 0.002).The highest shear bond strength was observed after 6 months in the NM group and the GD group with no statistically significant difference. The 24-hour bond strengths were not significant between groups. Mix failure had the highest rate in all groups. Conclusion It can be concluded that the effect of combination of chlorhexidine and Gluma on maintaining the integrity and strength of bond over time is similar to Gluma compound alone and they have better effect than chlorhexidine.",2020,"After 6 months, the bond strength decreased in all groups and differences were statistically significant ( p = 0.002).The highest shear bond strength was observed after 6 months in the NM group and the GD group with no statistically significant difference.",['One hundred and twenty caries-free extracted premolars were sectioned horizontally from one third of the coronal crown to expose flat dentin surface and randomly divided into 4 groups'],"['chlorhexidine', 'chlorhexidine (CHX', 'Gluma and chlorhexidine', 'Desensitizer, Chlorhexidine and Gluma']","['24-hour bond strengths', 'bond strength', 'shear bond strength', 'Bond Strength and Bond Longevity of Composite to Dentin', 'shear bond strength and bond durability']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0061452', 'cui_str': 'Gluma'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",120.0,0.0228334,"After 6 months, the bond strength decreased in all groups and differences were statistically significant ( p = 0.002).The highest shear bond strength was observed after 6 months in the NM group and the GD group with no statistically significant difference.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Davalloo', 'Affiliation': 'Dental Sciences Research Center, Dept. of Restorative Dentistry, Faculty of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Maryam', 'Initials': 'SM', 'LastName': 'Tavangar', 'Affiliation': 'Dental Sciences Research Center, Dept. of Restorative Dentistry, Faculty of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Heshmatollah', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Dept. of Medicinal Chemistry, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Darabi', 'Affiliation': 'Dental Sciences Research Center, Dept. of Restorative Dentistry, Faculty of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Mahmoudi', 'Affiliation': 'Postgraduate Student of Restorative Dentistry, Faculty of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}]","Journal of dentistry (Shiraz, Iran)",['10.30476/DENTJODS.2019.77756.0'] 2682,32583297,The Role of Ursodeoxycholic Acid (UDCA) in Cholelithiasis Management After One Anastomosis Gastric Bypass (OAGB) for Morbid Obesity: Results of a Monocentric Randomized Controlled Trial.,"INTRODUCTION Bariatric surgery leads to rapid weight loss, a well-known risk factor for gallstone formation. Postoperative biliary complication rate requiring cholecystectomy is between 0.9 and 7.5% after laparoscopic sleeve gastrectomy and between 6 and 50% after laparoscopic gastric bypass. Several authors recommended ursodeoxycholic acid (UDCA) administration to reduce gallstone formation after diet-induced weight reduction. The aim of this randomized monocentric study is to evaluate gallstone incidence after prophylactic administration of UDCA in patients undergoing one anastomosis gastric bypass (OAGB). METHODS Patients undergoing OAGB were prospectively randomized into 2 groups: the UDCA group receiving oral UDCA 600 mg/days for 6 months in the immediate postoperative days, and the control group not administered with UDCA. Each group included 95 patients. Abdominal ultrasound, clinical evaluation, and quality of life scoring with Gastrointestinal Quality of Life Index (GIQLI) were performed postoperatively in all patients at 3, 6, and 12 months. RESULTS At 12 months of postoperative follow-up, 4 (4.2%) and 24 patients (25.2%) showed gallstones in the UDCA group and control group, respectively (p < 0.05). Among those who developed gallstones, 8 (28.6%) cases were symptomatic whereas 20 (71.4%) did not show any symptom. No statistically significant difference in GIQLI score between the two groups was found. CONCLUSION OAGB, as other malabsorbent procedures, appears to have higher rate of cholelithiasis than purely restrictive procedures. In our prospective randomized controlled study, a regular postoperative UDCA intake during the first 6 months seems to significantly reduce cholelithiasis incidence after OAGB, with no case of intolerance reported. Further studies are needed to assess this issue.",2020,"No statistically significant difference in GIQLI score between the two groups was found. ","['Cholelithiasis Management', 'Morbid Obesity', 'Patients undergoing OAGB', 'patients undergoing one anastomosis gastric bypass (OAGB']","['Anastomosis Gastric Bypass (OAGB', 'ursodeoxycholic acid (UDCA', 'laparoscopic sleeve gastrectomy', 'laparoscopic gastric bypass', 'Ursodeoxycholic Acid (UDCA', 'UDCA group receiving oral UDCA', 'UDCA', 'control group not administered with UDCA']","['gallstone incidence', 'gallstone formation', 'GIQLI score', 'Abdominal ultrasound, clinical evaluation, and quality of life scoring with Gastrointestinal Quality of Life Index (GIQLI', 'gallstones', 'Postoperative biliary complication rate requiring cholecystectomy']","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]",,0.0262239,"No statistically significant difference in GIQLI score between the two groups was found. ","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'Department of Surgery, Hospital ""A. Rizzoli"", Lacco Ameno, Naples, Italy. Francesco_pizza@libero.it.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': ""D'Antonio"", 'Affiliation': 'Division of General and Emergency Surgery, AslNapoli2nord, Frattamaggiore, Naples, Italy.'}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Lucido', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Tolone', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Gianmattia', 'Initials': 'G', 'LastName': 'Del Genio', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': ""Dell'Isola"", 'Affiliation': 'Department of Infectious Diseases, AORN ""Dei Colli"" Naples, Naples, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Docimo', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gambardella', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}]",Obesity surgery,['10.1007/s11695-020-04801-z'] 2683,32583298,Impact of Routine and Long-Term Follow-Up on Weight Loss after Bariatric Surgery.,"BACKGROUND Weight loss after bariatric surgery varies among patients. Patients who do not complete long-term follow-up are considered to loose less weight than those with regular follow-up visits. OBJECTIVE To evaluate the influence of patients' follow-up compliance on long-term excess weight loss (%EWL) and total weight loss (%TWL) after bariatric surgery, comparing results between gastric bypass (GB) and sleeve gastrectomy (SG). METHODS Patients with up to 5 years of follow-up data after bariatric surgery were included in this retrospective analysis. Patients were divided in 2 groups: those in group 1 who had attended every scheduled postoperative appointment and those in group 2 who had been lost to follow-up before 1 year and were later contacted by telephone. %EWL and %TWL were compared to determine the possible relationship between type of surgery and regularity of the follow-up. RESULTS A total of 385 patients were included. A significant difference in EWL was observed at 5 years in the SG group (78% for group 1 versus 39% for group 2; p = 0.02) and GB group (75% for group 1 versus 62% for group 2; p = 0.01). No significant differences between surgeries were found when comparing long-term EWL in group 1 patients 77% for SG versus 75% for GB. For group 2 patients, GB achieved greater EWL than SG; p = 0.005. %TWL patients in group 2 showed significant differences in all periods of study (p < 0.05). CONCLUSION Bariatric surgery patients who attended all scheduled follow-up appointments experienced significantly greater long-term EWL and TWL than those who did not. GB has apparent increased benefits for weight loss in long-term follow-up when compared with SG for patients who did not attend long-term follow-up. Therefore, continued long-term follow-up of bariatric patients should be encouraged to increase postoperative weight loss results.",2020,No significant differences between surgeries were found when comparing long-term EWL in group 1 patients 77% for SG versus 75% for GB.,"['Patients were divided in 2 groups: those in group 1 who had attended every scheduled postoperative appointment and those in group 2 who had been lost to follow-up before 1\xa0year and were later contacted by telephone', 'A total of 385 patients were included', 'Patients with up to 5\xa0years of follow-up data after bariatric surgery', 'patients', 'after Bariatric Surgery', 'Patients who do not complete long-term follow-up are considered to loose less weight than those with regular follow-up visits']","['gastric bypass (GB) and sleeve gastrectomy (SG', 'GB', 'Routine and Long-Term Follow-Up']","['total weight loss', 'weight loss', 'EWL', 'Weight Loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",385.0,0.0227792,No significant differences between surgeries were found when comparing long-term EWL in group 1 patients 77% for SG versus 75% for GB.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lujan', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tuero', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Landecho', 'Affiliation': 'Department of Internal Medicine, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Moncada', 'Affiliation': 'Department of Anesthesiology, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'A Cienfuegos', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rotellar', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': 'Department of Endocrinology, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lapuente', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martínez', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Frühbeck', 'Affiliation': 'Department of Endocrinology, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Valenti', 'Affiliation': 'Department General Surgery, Bariatric and Metabolic Surgery, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain. vvalenti@unav.es.'}]",Obesity surgery,['10.1007/s11695-020-04788-7'] 2684,32583300,A Comprehensive Approach for the Prevention of Nausea and Vomiting Following Sleeve Gastrectomy: a Randomized Controlled Trial.,"BACKGROUND Postoperative nausea and vomiting (PONV) following sleeve gastrectomy (SG) is a common occurrence. The effect of specific interventions in PONV prevention within enhanced recovery pathways remains unclear. The aim of this study was to evaluate the impact of a comprehensive approach for the prevention of PONV on patient outcomes and hospital resource utilization. METHODS A prospective randomized trial was conducted for patients undergoing SG. The intervention group received aprepitant and transdermal scopolamine preoperatively followed by ondansetron and dexamethasone intraoperatively, with total intravenous anesthesia. The control group received inhalational anesthetic and two intraoperative antiemetics without preoperative prophylaxis. The primary endpoint was a PONV-related delay in hospital discharge. RESULTS Eighty-three patients completed the study (41 in the intervention and 42 in the control group). Eighty-nine percent of patients were discharged home on the first postoperative day. Four patients in the control group and none in the intervention group experienced a PONV-related delay in discharge (9.5% vs 0, p = 0.119). Intervention patients reported significantly lower PONV scores at all in-hospital time points examined (p = 0.0392 for verbal scores and p < 0.0001 for Rhodes Index) and significantly higher self-rated quality of recovery at 24 h (Quality of Recovery-15 instrument, p < 0.05). CONCLUSIONS A multilevel approach to PONV leads to significantly lower severity of PONV and improved self-reported quality of recovery, compared with control. PONV-related readmissions, ED visits, and discharge delays were uncommon within the overall enhanced recovery cohort.",2020,"Intervention patients reported significantly lower PONV scores at all in-hospital time points examined (p = 0.0392 for verbal scores and p < 0.0001 for Rhodes Index) and significantly higher self-rated quality of recovery at 24 h (Quality of Recovery-15 instrument, p < 0.05). ","['patients undergoing SG', 'Eighty-three patients completed the study (41 in the intervention and 42 in the control group']","['aprepitant and transdermal scopolamine preoperatively followed by ondansetron and dexamethasone', 'Sleeve Gastrectomy', 'sleeve gastrectomy (SG', 'inhalational anesthetic and two intraoperative antiemetics without preoperative prophylaxis']","['PONV-related readmissions, ED visits, and discharge delays', 'Nausea and Vomiting', 'PONV-related delay in discharge', 'PONV scores', 'self-rated quality of recovery', 'PONV-related delay in hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.127697,"Intervention patients reported significantly lower PONV scores at all in-hospital time points examined (p = 0.0392 for verbal scores and p < 0.0001 for Rhodes Index) and significantly higher self-rated quality of recovery at 24 h (Quality of Recovery-15 instrument, p < 0.05). ","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Spaniolas', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA. konstantinos.spaniolas@stonybrookmedicine.edu.'}, {'ForeName': 'Lizhou', 'Initials': 'L', 'LastName': 'Nie', 'Affiliation': 'Department of Family, Population & Preventive Medicine, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Daryn', 'Initials': 'D', 'LastName': 'Moller', 'Affiliation': 'Department of Anesthesiology, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Talar', 'Initials': 'T', 'LastName': 'Tatarian', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Hesketh', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Family, Population & Preventive Medicine, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Docimo', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Tong J', 'Initials': 'TJ', 'LastName': 'Gan', 'Affiliation': 'Department of Anesthesiology, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Pryor', 'Affiliation': 'Department of Surgery, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.'}]",Obesity surgery,['10.1007/s11695-020-04795-8'] 2685,32583313,"Allisartan Isoproxil Improves Endothelial Function and Vascular Damage in Patients with Essential Hypertension: A Single-Center, Open-Label, Randomized Controlled Trial.","INTRODUCTION Allisartan isoproxil is a novel angiotensin II type 1 receptor antagonist that has been confirmed to lower blood pressure and protect target organs effectively. However, its role in improving endothelial function and vascular damage has not been investigated yet. METHODS Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99 mmHg) with age from 25-75 years were randomly assigned 1:1 to either the allisartan group (allisartan 240 mg/day and lifestyle modification) or the lifestyle modification group and were followed up for 30 days. Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage. In addition, we enrolled 36 normotensive individuals as healthy control. RESULTS Seventy-two mildly hypertensive patients were enrolled in this study. After 30 days of treatment, a significant increase in FMD was observed in the allisartan group (0.9 ± 0.7%, p < 0.001) and remained unchanged in the lifestyle modification group, but the difference between the two groups did not reach statistical significance (p = ns). EMPs, baPWV, SBP and DBP decreased by 251.0 ± 255.9 counts/μl (p < 0.001), 102.8 ± 84.2 cm/s (p < 0.001), 13.20 ± 3.9 mmHg (p < 0.001) and 9.35 ± 2.5 mmHg (p < 0.001), respectively, in the allisartan group, while by 21.3 ± 84.3 counts/μl (p = ns), 0.4 ± 22.0 cm/s (p = ns), 3.2 ± 6.0 mmHg (p < 0.01) and 1.0 ± 2.5 mmHg (p = ns), respectively, in the lifestyle modification group. All of the indexes above achieved statistical significance between the allisartan and lifestyle modification groups (p < 0.05). Besides, after 30 days of allisartan administration baPWV and EMPs were comparable to those measured in the healthy control group, while the difference in SBP, DBP and FMD remained significant between the allisartan and healthy control groups (p < 0.05). CONCLUSION The present study demonstrates for the first time that allisartan isoproxil exerts a favorable effect on improving endothelial function and vascular damage in patients with mild EH, making it a promising drug for management of EH. CLINICAL TRIAL REGISTRATION ChiCTR2000032332.",2020,"Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage.","['patients with mild EH', 'Seventy-two mildly hypertensive patients', 'Patients with Essential Hypertension', 'Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99\xa0mmHg) with age from 25-75\xa0years', '36 normotensive individuals as healthy control']","['allisartan group (allisartan 240\xa0mg/day and lifestyle modification) or the lifestyle modification', 'Allisartan Isoproxil']","['EMPs, baPWV, SBP and DBP', 'Endothelial Function and Vascular Damage', 'FMD', 'SBP, DBP and FMD', 'Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial\xa0microparticles (EMPs', 'endothelial function and vascular damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3849367', 'cui_str': 'allisartan isoproxil'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",36.0,0.0670531,"Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage.","[{'ForeName': 'Gaoxing', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuanya', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China. taojungz123@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01413-y'] 2686,32470438,"Evaluation of the efficacy and safety of deferiprone compared with deferasirox in paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2): a multicentre, randomised, open-label, non-inferiority, phase 3 trial.","BACKGROUND Transfusion-dependent haemoglobinopathies require lifelong iron chelation therapy with one of the three iron chelators (deferiprone, deferasirox, or deferoxamine). Deferasirox and deferiprone are the only two oral chelators used in adult patients with transfusion-dependent haemoglobinopathies. To our knowledge, there are no randomised clinical trials comparing deferiprone, a less expensive iron chelator, with deferasirox in paediatric patients. We aimed to show the non-inferiority of deferiprone versus deferasirox. METHODS DEEP-2 was a phase 3, multicentre, randomised trial in paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies. The study was done in 21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK. Participants were receiving at least 150 mL/kg per year of red blood cells for the past 2 years at the time of enrolment, and were receiving deferoxamine (<100 mg/kg per day) or deferasirox (<40 mg/kg per day; deferasirox is not registered for use in children aged <2 years so only deferoxamine was being used in these patients). Any previous chelation treatment was permitted with a 7-day washout period. Patients were randomly assigned 1:1 to receive orally administered daily deferiprone (75-100 mg/kg per day) or daily deferasirox (20-40 mg/kg per day) administered as dispersible tablets, both with dose adjustment for 12 months, stratified by age (<10 years and ≥10 years) and balanced by country. The primary efficacy endpoint was based on predefined success criteria for changes in serum ferritin concentration (all patients) and cardiac MRI T2-star (T2*; patients aged >10 years) to show non-inferiority of deferiprone versus deferasirox in the per-protocol population, defined as all randomly assigned patients who received the study drugs and had available data for both variables at baseline and after 1 year of treatment, without major protocol violations. Non-inferiority was based on the two-sided 95% CI of the difference in the proportion of patients with treatment success between the two groups and was shown if the lower limit of the two-sided 95% CI was greater than -12·5%. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with EudraCT, 2012-000353-31, and ClinicalTrials.gov, NCT01825512. FINDINGS 435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group). 352 (90%) of 390 patients had β-thalassaemia major, 27 (7%) had sickle cell disease, five (1%) had thalassodrepanocytosis, and six (2%) had other haemoglobinopathies. Median follow-up was 379 days (IQR 294-392) for deferiprone and 381 days (350-392) for deferasirox. Non-inferiority of deferiprone versus deferasirox was established (treatment success in 69 [55·2%] of 125 patients assigned deferiprone with primary composite efficacy endpoint data available at baseline and 1 year vs 80 [54·8%] of 146 assigned deferasirox, difference 0·4%; 95% CI -11·9 to 12·6). No significant difference between the groups was shown in the occurrence of serious and drug-related adverse events. Three (2%) cases of reversible agranulocytosis occurred in the 193 patients in the safety analysis in the deferiprone group and two (1%) cases of reversible renal and urinary disorders (one case of each) occurred in the 197 patients in the deferasirox group. Compliance was similar between treatment groups: 183 (95%) of 193 patients in the deferiprone group versus 192 (97%) of 197 patients in the deferisirox group. INTERPRETATION In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment. Considering the need for availability of more chelation treatments in paediatric populations, deferiprone offers a valuable treatment option for this age group. FUNDING EU Seventh Framework Programme.",2020,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","['paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2', 'paediatric patients with transfusion-dependent', '21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK', 'paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies', 'group versus 192 (97%) of 197 patients in the deferisirox group', '435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group', 'adult patients with transfusion-dependent haemoglobinopathies', 'paediatric patients']","['daily deferasirox', 'daily deferiprone', 'deferoxamine', 'haemoglobinopathies, deferiprone', 'Deferasirox and deferiprone', 'deferiprone', 'deferasirox', 'deferiprone versus deferasirox']","['Safety', 'Compliance', 'serum ferritin concentration', 'efficacy and safety', 'occurrence of serious and drug-related adverse events', 'sickle cell disease', 'reversible agranulocytosis', 'reversible renal and urinary disorders']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0001824', 'cui_str': 'Agranulocytosis'}, {'cui': 'C0042075', 'cui_str': 'Disorder of urinary tract'}]",435.0,0.255378,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","[{'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Maggio', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy. Electronic address: aurelio.maggio@villasofia.it.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kattamis', 'Affiliation': 'First Department of Pediatrics, National and Kapodistriam University of Athens, Athens, Greece.'}, {'ForeName': 'Mariagrazia', 'Initials': 'M', 'LastName': 'Felisi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Reggiardo', 'Affiliation': 'Biostatistics and Data Management Unit, Medi Service, Genoa, Italy.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'El-Beshlawy', 'Affiliation': 'Pediatric Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bejaoui', 'Affiliation': 'Pediatrics and Bone Marrow Transplantation Centre, Tunis, Tunisia.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Sherief', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Soteroula', 'Initials': 'S', 'LastName': 'Christou', 'Affiliation': 'Thalassaemia Center, Hospital Archbishop Makarios III, Nicosia, Cyprus.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cosmi', 'Affiliation': 'Clinica Pediatrica, Azienda Ospedaliero Universitaria (AOU) Sassari, Sassari, Italy.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'Clinical Pharmacology and Therapeutics Group, University College London, London, UK.'}, {'ForeName': 'Giovanni Carlo', 'Initials': 'GC', 'LastName': 'Del Vecchio', 'Affiliation': 'UO Pediatrica B Trambusti, AOU Consorziale Policlinico-Giovanni XXIII, Bari, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Filosa', 'Affiliation': 'UOSD Malattie rare del globulo rosso, AORN A Cardarelli, Napoli, Italy.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Cuccia', 'Affiliation': 'UOC Ematologia con Talassemia, Dipartimento di Medicina, AO Civico Di Cristina-Benfratelli, Palermo, Italy.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Hassab', 'Affiliation': 'Department of Pediatrics and Clinical Research Center, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Manika', 'Initials': 'M', 'LastName': 'Kreka', 'Affiliation': 'Pediatrics Department, University Hospital Center Mother Teresa, Tirana, Albania.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': 'DH Talassemia, Ospedale Pediatrico Microcitemico A CAO, AO G Brotzu, Cagliari, Italy.'}, {'ForeName': 'Maria Caterina', 'Initials': 'MC', 'LastName': 'Putti', 'Affiliation': ""Department of Women's and Child's Health (DSDB), University Hospital, Padova, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spino', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Telfer', 'Affiliation': 'Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Tempesta', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vitrano', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'Yu Chung', 'Initials': 'YC', 'LastName': 'Tsang', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Zaka', 'Affiliation': 'Center of Thalassemia, Hospital Ihsan Cabej, Lushnje, Albania.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Tricta', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Bonifazi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ceci', 'Affiliation': 'Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Valenzano, Italy.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30100-9'] 2687,32473365,Central nervous system activities of extract Mangifera indica L.,"ETHNOBOTANICAL RELEVANCE Leaves of Mangifera indica L. have folk-uses in tropical regions of the world as health teas, as a remedy for exhaustion and fatigue, as a vegetable, and as a medicine. Mangifera indica leaf extract (MLE) had previously been demonstrated to alter brain electrical activity in-vivo. The aim of the present series of studies was to investigate whether mangiferin, a major compound in leaves and in MLE, is responsible for the neurocognitive activity of MLE, and if the CNS activities of MLE have translational potential. MATERIALS AND METHODS MLE, tradename Zynamite, is produced by Nektium Pharma, Spain. Isolated mangiferin was tested in-vitro in radioligand binding and enzyme inhibition studies against 106 CNS targets. Changes in the electroencephalograms (EEG's) of MLE and mangiferin were recorded in-vivo from four brain regions. Two double blind randomized placebo-controlled crossover clinical trials were conducted, each with 16 subjects. At 90 min and at 60 min respectively, after oral intake of 500 mg MLE, EEG recordings, psychometric tests, mood state, and tolerability were studied. RESULTS Isolated mangiferin is a selective inhibitor of catechol-O-methyltransferase (COMT) with an IC50 of 1.1 μM, with no activity on the CNS targets of caffeine. Both mangiferin and MLE induce similar changes in long-term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo. In both translational clinical trials MLE was well tolerated, with no cardiovascular side-effects. In both studies MLE caused significant spectral changes in brain electrical activity in cortical regions during cognitive challenges, different to the attenuated spectral changes induced by caffeine. There were no significant changes in the psychometric tests other than reaction time for all groups. In the second study there was a trend to faster reaction time within group for MLE (p = 0.066) and the percentage improvement in reaction time for MLE compared to placebo was significant (p = 0.049). In the first study MLE improved all scores for Profile of Mood States (POMS), with the score for ""fatigue"" significantly improved (p = 0.015); in the second study the POMS score for ""dejection"" was improved in the caffeine group, p = 0.05. CONCLUSIONS Mangiferin is a COMT inhibitor of moderate potency and is the major CNS-active compound in MLE. Both mangiferin and MLE increase hippocampal LTP in-vitro, and induce a similar pattern of changes in brain electrical activity in-vivo. While the translational clinical trials of MLE are limited by being single dose studies in a small number of subjects, they provide the first clinical evidence that the extract is well tolerated with no cardiovascular side-effects, can induce changes in brain electrical activity, may give a faster reaction time, and decrease fatigue. These CNS activities support the reported folk-uses use of mango leaf tea as a substitute for tea and as a traditional remedy for fatigue and exhaustion. Extract Mangifera indica L., Zynamite, has nootropic potential, and larger clinical studies are needed to realise this potential.",2020,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.",['16 subjects'],"['Mangifera indica leaf extract (MLE', 'caffeine', 'mangiferin and MLE', 'MLE', 'extract Mangifera indica L', 'placebo']","['fatigue', 'POMS score for ""dejection', 'Profile of Mood States (POMS', 'brain electrical activity', 'psychometric tests, mood state, and tolerability', 'reaction time for MLE', 'faster reaction time']",[],"[{'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0364453,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: llopez@nektium.com.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: jwiebe@nektium.com.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: tvega@nektium.com.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gericke', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain; Department of Botany and Plant Biotechnology, University of Johannesburg, Auckland Park, 2006, Johannesburg, South Africa. Electronic address: ngericke@nektium.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112996'] 2688,32473378,Annexin A1 is a Potential Novel Biomarker of Congestion in Acute Heart Failure.,"OBJECTIVES This study sought to identify the role of annexin A1 (AnxA1) as a congestion marker in acute heart failure (AHF) and to identify its putative role in predicting clinical outcomes. BACKGROUND AnxA1 is a protein that inhibits inflammation following ischemia-reperfusion injury in cardiorenal tissues. Because AHF is a state of tissue hypoperfusion, we hypothesized that plasma AnxA1 levels are altered in AHF. METHODS In the Renal Optimization Strategies Evaluation (ROSE) trial, patients hospitalized for AHF with kidney injury were randomized to receive dopamine, nesiritide, or placebo for 72 hours in addition to diuresis. In a subanalysis, plasma AnxA1 levels were measured at baseline and at 72 hours in 275 patients. Participants were divided into 3 tertiles based on their baseline AnxA1 levels. RESULTS The prevalence of peripheral edema 2+ increased with increasing AnxA1 levels (P < .007). Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (P< .05). Patients with a congestion score of 4 had a mean baseline AnxA1 level 8.63 units higher than those with a congestion score of 0 (P = .03). Patients in tertiles 2 and 3 were twice as likely to experience creatinine elevation as patients in tertile 1 (P = .03). Patients in tertiles 2 and 3 were at a higher risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality (P < .05). CONCLUSIONS Among patients hospitalized for AHF with impaired kidney function, elevated AnxA1 levels are associated with worse congestion, higher risk for further creatinine elevation, and higher rates of 60-day morbidity or all-cause mortality and 180-day all-cause mortality. CLINICAL TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01132846.",2020,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).",['patients hospitalized for AHF with kidney injury'],"['dopamine, nesiritide, or placebo', 'nAnnexin A1', 'Annexin A1']","['plasma AnxA1 levels', '60-day morbidity', 'Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels', 'risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality', 'experience creatinine elevation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.20289,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).","[{'ForeName': 'Fadi W', 'Initials': 'FW', 'LastName': 'Adel', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Rikhi', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Siu-Hin', 'Initials': 'SH', 'LastName': 'Wan', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Seethalakshmi R', 'Initials': 'SR', 'LastName': 'Iyer', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. Electronic address: Chen.Horng@mayo.edu.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.05.012'] 2689,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045'] 2690,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population. METHODS This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH. CONCLUSION This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047'] 2691,32476558,"Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care.","OBJECTIVE The aim of this study was to determine the effect of web-based education and counselling for patients with systemic lupus erythematosus on self-efficacy, fatigue and assessment of care. METHODS The study was conducted as a randomized controlled trial. The study sample consisted of 80 patients divided into two groups: the experimental group ( n  = 40) and a control group ( n  = 40). Randomization was performed by simple random sampling. At the beginning of the study (month 0), data-collection forms were administered to both groups. Web-based education was carried out for the first three months, and counselling and information updates were given for the next three months for the experimental group. In the intervention process, the control group just received standard care. After six months, data-collection forms were administered to both groups again. RESULTS The mean age of the participants in the experimental and control groups was 35.58 ± 8.40 years and 39.00 ± 12.71 years, respectively. In both groups, 95% of patients were women. Wilcoxon's test was used for within-group comparisons before and after the study. The Mann-Whitney U -test was used to evaluate the difference between the two groups before the intervention and between the two groups after the intervention. We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p  < 0.05). CONCLUSIONS The intervention had a positive effect on self-efficacy, fatigue and satisfaction with chronic illness. In accordance with the results, similar studies should be conducted for different patient groups in order to strengthen the results.",2020,"We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p  < 0.05). ","['The mean age of the participants in the experimental and control groups was 35.58\u2009±\u20098.40 years and 39.00\u2009±\u200912.71 years, respectively', 'patients with systemic lupus erythematosus']","['standard care', 'web-based education and counselling']","['fatigue, self-efficacy and assessment of chronic illness care', 'self-efficacy, fatigue and satisfaction with chronic illness']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",80.0,0.0447442,"We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p  < 0.05). ","[{'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Kankaya', 'Affiliation': 'Ege University, Faculty of Nursing, Department of Medical Nursing, Izmir, Turkey.'}, {'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Karadakovan', 'Affiliation': 'Ege University, Faculty of Nursing, Department of Medical Nursing, Izmir, Turkey.'}]",Lupus,['10.1177/0961203320928423'] 2692,32482712,"Association between Subcutaneous Adipose Tissue Inflammation, Insulin Resistance, and Calorie Restriction in Obese Females.","The worldwide epidemic of overweight and obesity has led to an increase in associated metabolic comorbidities. Obesity induces chronic low-grade inflammation in white adipose tissue (WAT). However, the function and regulation of both innate and adaptive immune cells in human WAT under conditions of obesity and calorie restriction (CR) is not fully understood yet. Using a randomized interventional design, we investigated postmenopausal overweight or obese female subjects who either underwent CR for 3 mo followed by a 4-wk phase of weight maintenance or had to maintain a stable weight over the whole study period. A comprehensive immune phenotyping protocol was conducted using validated multiparameter flow cytometry analysis in blood and s.c. WAT (SAT). The TCR repertoire was analyzed by next-generation sequencing and cytokine levels were determined in SAT. Metabolic parameters were determined by hyperinsulinemic-euglycemic clamp. We found that insulin resistance correlates significantly with a shift toward the memory T cell compartment in SAT. TCR analysis revealed a diverse repertoire in SAT of overweight or obese individuals. Additionally, whereas weight loss improved systemic insulin sensitivity in the intervention group, SAT displayed no significant improvement of inflammatory parameters (cytokine levels and leukocyte subpopulations) compared with the control group. Our data demonstrate the accumulation of effector memory T cells in obese SAT and an association between systemic glucose homeostasis and inflammatory parameters in obese females. The long-standing effect of obesity-induced changes in SAT was demonstrated by preserved immune cell composition after short-term CR-induced weight loss.",2020,"Additionally, whereas weight loss improved systemic insulin sensitivity in the intervention group, SAT displayed no significant improvement of inflammatory parameters (cytokine levels and leukocyte subpopulations) compared with the control group.","['obese females', 'Obese Females', 'postmenopausal overweight or obese female subjects who either underwent CR for 3 mo followed by a 4-wk phase of weight maintenance or had to maintain a stable weight over the whole study period']",[],"['TCR repertoire', 'inflammatory parameters (cytokine levels and leukocyte subpopulations', 'Subcutaneous Adipose Tissue Inflammation, Insulin Resistance, and Calorie Restriction', 'Metabolic parameters', 'weight loss improved systemic insulin sensitivity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.0276917,"Additionally, whereas weight loss improved systemic insulin sensitivity in the intervention group, SAT displayed no significant improvement of inflammatory parameters (cytokine levels and leukocyte subpopulations) compared with the control group.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sbierski-Kind', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany; julia.sbierski-kind@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Kath', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Jurisch', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Streitz', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kuchenbecker', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Babel', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Mikalai', 'Initials': 'M', 'LastName': 'Nienen', 'Affiliation': 'Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Jürchott', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Spranger', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Reiner', 'Initials': 'R', 'LastName': 'Jumpertz von Schwartzenberg', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Decker', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Krüger', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Hans-Dieter', 'Initials': 'HD', 'LastName': 'Volk', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}]","Journal of immunology (Baltimore, Md. : 1950)",['10.4049/jimmunol.2000108'] 2693,32484533,Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.,"Importance Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates. Objective To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality. Design, Setting, and Participants Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019. Interventions Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743). Main Outcomes and Measures The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality. Results Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important). Conclusions and Relevance Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.",2020,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","['1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n\u2009=\u2009735 in both randomization groups) and were included in the analysis', 'women with 1 previous cesarean delivery', 'A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019']","[""tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool"", 'patient-centered decision support tool', 'Patient-Centered Decision Support Tool']","['labor; vaginal birth', 'labor rates', 'cesarean delivery rates', '5 decision quality measures (eg, mean decisional conflict scores', 'Rates of Trial of Labor', 'rate of trial of labor', 'rates of trial of labor and vaginal birth', 'vaginal birth rates', 'maternal and neonatal outcomes and decision quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.215832,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Anjali J', 'Initials': 'AJ', 'LastName': 'Kaimal', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Blat', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Mari-Paule', 'Initials': 'MP', 'LastName': 'Thiet', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Yamilee', 'Initials': 'Y', 'LastName': 'Bermingham', 'Affiliation': 'Marin Community Clinic, San Rafael, California.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Altshuler', 'Affiliation': 'California Pacific Medical Center, San Francisco.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bryant', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}]",JAMA,['10.1001/jama.2020.5952'] 2694,32480076,Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset.,"The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3-5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.",2020,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","['Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study', 'Patients with first-ever stroke and requiring a walking aid started gait training within 1\xa0week of stroke onset', 'patients with acute stroke']","['Gait training using HAL', 'gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI', 'robot-assisted gait training', 'conventional physical therapy (CPT) group or gait training using HAL (HAL', 'gait training with Hybrid Assistive Limb']","['Motor function and DTI', 'changes in FA (ΔFA', 'contra-lesional rostrum of the corpus callosum', 'motor function and independency', 'FA in the ipsi-lesional cerebral peduncle']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0152322', 'cui_str': 'Structure of rostrum of corpus callosum'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}]",27.0,0.0293157,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yokota', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; Department of Stroke Rehabilitation, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: cyokota@ncvc.go.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Koshino', 'Affiliation': 'Department of Systems and Informatics, Hokkaido Information University, Ebetsu, Japan. Electronic address: koshino@do-johodai.ac.jp.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Yasuno', 'Affiliation': 'Department of Psychiatry, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan. Electronic address: yasunof@ncgg.go.jp.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Industrial-Academic Collaboration, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: ayamamot@ncvc.go.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Odani', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. Electronic address: nakajima.takashi.ud@mail.hosp.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nuclear Medicine and Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Tatsumi', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: tatsumi@ncvc.go.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116939'] 2695,32480103,Safety and placement stability for the Children's Home Network kinship navigator program.,"BACKGROUND With the passage of the Families First Prevention Act, kinship navigator programs have growing support as an intervention to connect kinship families to needed resources. Growing evidence has helped to showcase the outcomes, but no study has shared follow up outcomes past twelve months. OBJECTIVE This study examined the 12, 24 and 36 month follow up child safety (substantiated abuse record) and placement stability (disruption in placement) outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN). SETTING Study participants were 240 (60 in each group) randomly selected kinship caregivers who were enrolled in four treatment groups in CHN-KN (Standard Kinship Navigator, Kinship Navigator with Innovations, Kinship Navigator with Peer-to-Peer only, and Usual Child Welfare). METHODS Repeated measures anovas were used to show between group differences for each study group. RESULTS Results show that children living with caregivers who received Kinship Navigator Programs (Kinship Navigator Peer to Peer and Kinship Navigator with Innovations) were the least likely to be involved in a substantiation of child abuse or neglect and most likely to remain in the home of a relative at 12, 24 and 36 month follow up. CONCLUSIONS Results suggest that the kinship navigator programs could improve child safety and placement stability. This study can help to inform the replication of the CHN-KN model and provide additional supported evidence to inform practice.",2020,"outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN). ","[""Children's Home Network kinship navigator program"", 'Study participants were 240 (60 in each group) randomly selected kinship caregivers who were enrolled in four treatment groups in', ""children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN"", 'children living with caregivers']","['CHN-KN (Standard Kinship Navigator, Kinship Navigator with Innovations, Kinship Navigator with Peer-to-Peer only, and Usual Child Welfare', 'Kinship Navigator Programs (Kinship Navigator Peer to Peer and Kinship Navigator with Innovations']","['Safety and placement stability', 'child safety (substantiated abuse record) and placement stability (disruption in placement', 'child safety and placement stability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",240.0,0.0249446,"outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN). ","[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Littlewood', 'Affiliation': 'The University of South Florida School of Social Work, Tampa, FL, United States. Electronic address: littlewood@usf.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Cooper', 'Affiliation': ""Children's Home Network, Tampa, FL, 33620, United States. Electronic address: lcooper@childrenshomenetwork.org.""}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'The University of South Florida, Tampa, FL, United States. Electronic address: apandey47@gmail.com.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104506'] 2696,32481623,Changes in Thyroid and Glycemic Status and Food Intake in Children with Excess Weight Who Were Submitted for a Multi-Component School Intervention for 16 Months.,"We investigated if children with excess weight who submitted to two types of intervention at school for 16 months showed improvements in thyroid and glycemic function and food intake. Children (8-11 years) with a body mass index-for-age (BMI/A) of ≥1 Z score were divided into two groups: Treatment 1 ( n = 73) involved motivation to adopt healthier lifestyle; Treatment 2 ( n = 103) involved performing weekly nutritional education, motivational, and physical activities at school. A semi-quantitative food frequency questionnaire was used. The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L, p = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15 (-2.46 to 1.38) pmol/L, p = 0.038), and FreeT4 -1.41 (-6.18 to 3.47) and -0.90 (-4.89 to 2.96) pmol/L, p = 0.018), followed by decrease in energy intake (7304 (6806 to 7840) and 8267 (7739 to 8832) kJ, P treatment = 0.439, P time <0.001, interaction group-time p < 0.001), macronutrients and sugar. A positive correlation between FreeT3 and BMI/A, and a negative correlation with FreeT4 and insulin were found at baseline (r 0.212, p < 0.01; r -0.155, p < 0.01, respectively) and follow-up (r 0.222, p < 0.01; r -0.221, p < 0.01). The decrease in overall diet and particularly sugar intake was accompanied by a greater reduction in TSH and FreeT3 in Treatment 1, demonstrating the impact of dietary intake on thyroid function.",2020,"The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L, p = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15","['Children with Excess Weight', 'children with excess weight who submitted to two types of intervention at school for 16 months', 'Children (8-11 years) with a body mass index-for-age (BMI/A) of ≥1 Z score']","['motivation to adopt healthier lifestyle; Treatment 2 ( n = 103) involved performing weekly nutritional education, motivational, and physical activities at school']","['Thyroid and Glycemic Status and Food Intake', 'thyroid-stimulating hormone', 'thyroid and glycemic function and food intake', 'overall diet and particularly sugar intake', 'energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0203566,"The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L, p = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15","[{'ForeName': 'Vinicius J B', 'Initials': 'VJB', 'LastName': 'Martins', 'Affiliation': 'Department of Physiology and Pathology, Federal University of Paraíba, Health Sciences Center, Campus I, Cidade Universitária, João Pessoa, PB 58051-900, Brazil.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Filgueiras', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}, {'ForeName': 'Viviane B P', 'Initials': 'VBP', 'LastName': 'Almeida', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}, {'ForeName': 'Rúbia C S', 'Initials': 'RCS', 'LastName': 'de Moraes', 'Affiliation': 'Department of Nutrition, Federal University of Paraíba, Health Sciences Center, Campus I, Cidade Universitária, João Pessoa, PB 58051-900, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Sawaya', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17113825'] 2697,32491082,Theory-based training to promote breast cancer screening among women with breast cancer worries: randomized controlled trial.,"BACKGROUND Breast cancer worries are important determinants in relation to behavior favoring breast cancer screening. OBJECTIVE To determine the effect of theory-based training to promote breast cancer screening among women with high and low levels of breast cancer worries. DESIGN AND SETTING Randomized controlled trial, conducted in two family health centers. METHODS In total, 285 women were recruited. Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women). Theory-based training to promote breast cancer screening was given to intervention groups. The women's willingness to undergo breast cancer screening and breast cancer worry scores were evaluated at 1, 3 and 6 months. RESULTS The women in the low cancer-worry intervention group performed breast self-examination more in months 1 and 6 following the training, and the women in the high cancer-worry control group performed breast self-examination more in month 3 (P < 0.05). No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05). CONCLUSION The level of worry did not affect the success of theory-based training, and the training was partially effective with regard to willingness to undergo breast cancer screening.",2020,"No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05). ","['285 women were recruited', 'women with breast cancer worries', 'Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women', 'women with high and low levels of breast cancer worries', 'two family health centers']","['Theory-based training to promote breast cancer screening', 'theory-based training']","['breast self-examination', ""women's willingness to undergo breast cancer screening and breast cancer worry scores"", 'breast cancer worries']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}]","[{'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",285.0,0.0222049,"No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05). ","[{'ForeName': 'Sermin Timur', 'Initials': 'ST', 'LastName': 'Taşhan', 'Affiliation': ""Department of Birth, Women's Health and Illness, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.""}, {'ForeName': 'Yeşim Aksoy', 'Initials': 'YA', 'LastName': 'Derya', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Inönü Üniversitesi, Malatya, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Inönü Üniversitesi, Malatya, Turkey.'}, {'ForeName': 'Gülçin', 'Initials': 'G', 'LastName': 'Nacar', 'Affiliation': ""Department of Birth, Women's Health and Illness, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.""}, {'ForeName': 'Behice', 'Initials': 'B', 'LastName': 'Erci', 'Affiliation': 'Department of Public Health, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.'}]",Sao Paulo medical journal = Revista paulista de medicina,['10.1590/1516-3180.2019.033430092019'] 2698,32487334,Dexamethasone eardrop with grommet placement vs intratympanic steroid injection for sudden sensorineural hearing loss: A randomized prospective clinical trial.,"OBJECTIVES The purpose of this study was to compare different means of intratympanic steroid delivery in the treatment of idiopathic sudden sensorineural hearing loss. DESIGN Prospective, multicentered, randomized controlled trial. SETTING AND PARTICIPANTS Fifty-six patients who fulfilled the inclusion criteria for idiopathic sudden sensorineural hearing loss who failed or were contraindicated for oral steroids were included in this study. Patients were randomly divided into 2 groups according to delivery methods: group A received 4 sections of intratympanic dexamethasone injection and group B received grommet placement with dexamethasone delivery followed by 3 sections of dexamethasone ear drop application. Self-administered paper-based questionnaires were filled out to measure subjective pain scores, vertigo, anxiety, and overall satisfaction immediately after each procedure. Hearing threshold was measured with pure tone audiogram in the follow-up. RESULTS There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30). Grommet placement followed by dexamethasone eardrop application demonstrated a significant difference in shorter waiting time (24 min in grommet group vs 52 min in injection group; P < 0.01); and better overall satisfaction (1.6 in grommet group vs 2.5 in injection group; P < 0.05). CONCLUSIONS Grommet placement followed by dexamethasone eardrop application is a good alternative for a patient indicated for intratympanic steroid, with less administrative cost, shorter waiting time, and more satisfaction.",2020,There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30).,"['sudden sensorineural hearing loss', 'Fifty-six patients who fulfilled the inclusion criteria for idiopathic sudden sensorineural hearing loss who failed or were contraindicated for oral steroids were included in this study', 'idiopathic sudden sensorineural hearing loss']","['Dexamethasone eardrop with grommet placement vs intratympanic steroid injection', '4 sections of intratympanic dexamethasone injection and group B received grommet placement with dexamethasone delivery followed by 3 sections of dexamethasone ear drop application', 'intratympanic steroid delivery']","['subjective pain scores, vertigo, anxiety, and overall satisfaction', 'overall satisfaction', 'shorter waiting time', 'hearing threshold improvement']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1154187', 'cui_str': 'Ear drops'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",56.0,0.0352837,There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30).,"[{'ForeName': 'Wai Tsz', 'Initials': 'WT', 'LastName': 'Chang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong. Electronic address: waitsz@ent.cuhk.edu.hk.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Zee', 'Affiliation': 'School of Public Health, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herbert S H', 'Initials': 'HSH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong. Electronic address: herbertshlee@gmail.com.'}, {'ForeName': 'Michael C F', 'Initials': 'MCF', 'LastName': 'Tong', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102515'] 2699,32487336,Echinacea can help with Azithromycin in prevention of recurrent tonsillitis in children.,"PURPOSE Recurrent tonsillitis in children is a common disease affecting children quality of life and extends to their families. The aim of this study was to assess the effect of combined use of oral Azithromycin (AZT) plus Echinacea compared to exclusive use of AZT in children with recurrent tonsillitis. MATERIAL AND METHODS A prospective comparative study including three groups of children with recurrent tonsillitis. Group 1: (100 patients) had no prophylactic treatment. Group 2 (100 patients) received [60 mg/kg] prophylactic dose of AZT divided as (10 mg/kg/day) over 6 consecutive days every month for 6 consecutive months. Group 3 (100 patients) received AZT as in group 2 plus commercially available Echinacea in a dose of 5 ml oral suspension; 3 times daily for 10 consecutive days every month for 6 consecutive months. Number of tonsillitis attacks and severity of tonsillitis symptoms were assessed and compared in different groups. RESULTS Group 2 and group 3 had significant less number of tonsillitis attacks and severity of assessed symptoms during 6 months of prophylactic treatment with significant better results in group 3 (i.e. AZT plus Echinacea) compared to group 2 (I.e. AZT alone). However; there was no significant difference in patients with any prophylaxis. CONCLUSION The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.",2020,The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.,"['pediatric patients with recurrent tonsillitis', 'children with recurrent tonsillitis', 'children']","['AZT as in group 2 plus commercially available Echinacea in a dose of 5\u202fml oral suspension', 'Azithromycin', 'AZT', 'oral Azithromycin (AZT) plus Echinacea']","['Number of tonsillitis attacks and severity of tonsillitis symptoms', 'tonsillitis attacks and severity of assessed symptoms']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740402', 'cui_str': 'Tonsillitis recurrent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0752270', 'cui_str': 'Echinacea Preparation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0991537', 'cui_str': 'Oral suspension'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0177451,The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.,"[{'ForeName': 'Osama G', 'Initials': 'OG', 'LastName': 'Abdel-Naby Awad', 'Affiliation': 'Otolaryngology, Head and Neck Department, Minia University Hospital, 122 Kornish El-Neel Street, Minia City, Minia, Egypt. Electronic address: Usama.abdelnabi@mu.edu.eg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2019.102344'] 2700,32583567,The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial.,"OBJECTIVES Exploring the efficacy and safety of perioperative chemotherapy on patients with AGC at different clinical and pathological stages. METHODS A phase III randomized, multicenter, trial comparing adjuvant (arm A) or perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin (XELOX, arm C) was initiated in T3/4, node + gastric cancer patients (unclear). Each patient received an 8-cycle chemotherapy (3 weeks for one cycle). Group arms B and C received two cycles preoperatively, and six cycles postoperatively. Primary endpoints were R0 resection rate and DFS, and secondary endpoints included OS, ORR, DCR, and safety. This study was registered on Clinicaltrials.gov. NCT01516944. RESULTS A total of 749 patients were randomly assigned into groups A, B, and C. Group A received 1460 circles chemotherapy and group B received 1177 circles while group C received 1200 circles. R0 resection rates in the three groups were 81.7%, 88.7%, and 83.1%, respectively. The difference between groups A and B was considered to be statistically significant (P = .018), and no significant difference between groups B and C (P = .051). Hazard ratio were compared between groups B and C and DFS showed 0.72 (0.67-0.77 with 95% CI), P non-inferiority  < .0001, P log-rank  = .064). The CI top limit actually lower than the estimated value of 1.38, which indicated noninferiority of SOX to XELOX. CONCLUSIONS Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates. This study was powered to show superiority of perioperative over adjuvant SOX, and noninferiority of SOX to XELOX. Volume measurement, repeated laparoscopic exploration combined with exfoliative cytology can be used as a supplementary method in the clinical staging and efficacy evaluation of AGC.",2020,"Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates.","['749 patients', 'T3/4, node\xa0+\xa0gastric cancer patients (unclear', 'patients with advanced gastric cancer', 'patients with AGC at different clinical\xa0and pathological stages']","['PAC, perioperative chemotherapy', '1460 circles chemotherapy', '8-cycle chemotherapy', 'perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin (XELOX, arm C', 'laparoscopic exploration combined with exfoliative cytology', 'perioperative chemotherapy', 'neoadjuvant chemotherapy']","['R0 resection rates', 'R0 resection rate and DFS, and secondary endpoints included OS, ORR, DCR, and safety', 'efficacy and safety', 'R0 resection rates and prognosis', 'Hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205226', 'cui_str': 'Exfoliative'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",749.0,0.161197,"Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates.","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Lian', 'Affiliation': 'Surgical Oncology, Changzhi Medical College Affiliated Peace Hospital, Changzhi, Shanxi, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Huo', 'Affiliation': ""Gastrointestinal Tumor Surgery, Xingtai People's Hospital, Xingtai, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'General Surgery, The First Hospital of Shijiazhuang, Shijiazhuang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Liqiao', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Bibo', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Zhidong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Honghai', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Peigang', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Cancer medicine,['10.1002/cam4.3224'] 2701,32583630,Cognitive Remediation Therapy for patients with bipolar disorder: A randomised proof-of-concept trial.,"OBJECTIVES Cognitive remediation therapy (CRT) may benefit people with bipolar disorder type I and II for whom cognitive impairment is a major contributor to disability. Extensive research has demonstrated CRT to improve cognition and psychosocial functioning in people with different diagnoses, but randomised trials of evidenced therapy programmes are lacking for bipolar disorders. The Cognitive Remediation in Bipolar (CRiB) study aimed to determine whether an established CRT programme is feasible and acceptable for people with bipolar disorders. METHODS This proof-of-concept, single-blind randomised trial recruited participants aged 18-65 with bipolar disorder, not currently experiencing an episode. They were 1:1 block randomised to treatment-as-usual (TAU) with or without individual CRT for 12 weeks. The partly-computerised CRT programme (""CIRCuiTS"") was therapist-led and is evidence-based from trials in those with psychotic illnesses. Data were collected and analysed by investigators blinded to group allocation. The main outcomes (week 13 and 25) examined participant retention, intervention feasibility and putative effects of CRT on cognitive and psychosocial functioning via intention-to-treat analyses. TRIAL REGISTRATION ISRCTN ID32290525. RESULTS 60 participants were recruited (02/2016-06/2018) and randomised to CRT (n=29) or TAU (n=31). Trial withdrawals were equivalent (CRT n=2/29; TAU n=5/31). CRT satisfaction indicated high acceptability. Intention-to-treat analyses (N=60) demonstrated greater improvements for CRT- than TAU-randomised participants: at both week 13 and 25, CIRCuiTS participants showed larger improvements in the following domains (week 25 effect sizes reported here): IQ (SES=0.71, 95% CI [0.29,1.13]), working memory (SES=0.70, 95% CI [0.31,1.10]), executive function (SES=0.93, 95% CI [0.33,1.54]), psychosocial functioning (SES=0.49, 95% CI [0.18,0.80]) and goal attainment (SES=2.02, 95% CI [0.89,3.14]). No serious adverse events were reported. CONCLUSIONS CRT is feasible for individuals with bipolar disorders and may enhance cognition and functioning. The reported effect sizes from this proof-of-concept trial encourages further investigation in a definitive trial.",2020,"No serious adverse events were reported. ","['60 participants were recruited (02/2016-06/2018) and randomised to', 'people with bipolar disorders', 'patients with bipolar disorder', 'participants aged 18-65 with bipolar disorder, not currently experiencing an episode', 'individuals with bipolar disorders']","['CRT', 'established CRT programme', 'TAU', 'Cognitive Remediation Therapy', 'Cognitive remediation therapy (CRT', 'treatment-as-usual (TAU) with or without individual CRT']","['participant retention, intervention feasibility and putative effects of CRT on cognitive and psychosocial functioning via intention-to-treat analyses', 'psychosocial functioning', 'executive function', 'working memory', 'serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.39013,"No serious adverse events were reported. ","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Strawbridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Dimosthenis', 'Initials': 'D', 'LastName': 'Tsapekos', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics, King's Clinical Trials Unit, King's College London, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Mantingh', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nefize', 'Initials': 'N', 'LastName': 'Yalin', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Department of Health Services and Population Research, King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Boadu', 'Affiliation': ""Department of Health Services and Population Research, King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Macritchie', 'Affiliation': 'OPTIMA Mood Disorders Service, Lambeth Hospital, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cella', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Reeder', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fish', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]",Bipolar disorders,['10.1111/bdi.12968'] 2702,32583707,"Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial.","The purpose of this pilot randomized controlled trial is to assess the feasibility and impact of a triweekly 12-week yoga intervention among people living with HIV (PLWH). Additional objectives included evaluating cognition, physical function, medication adherence, health-related quality of life (HRQoL), and mental health among yoga participants versus controls using blinded assessors. We recruited 22 medically stable PLWH aged ≥35 years. A priori feasibility criteria were ≥70% yoga session attendance and ≥70% of participants satisfied with the intervention using a postparticipation questionnaire. Two participants withdrew from the yoga group. Mean yoga class attendance was 82%, with 100% satisfaction. Intention-to-treat analyses (yoga n = 11, control n = 11) showed no within- or between-group differences in cognitive and physical function. The yoga group improved over time in HRQoL cognition ( P = .047) with trends toward improvements in HRQoL health transition ( P =.063) and depression ( P = .055). This pilot study provides preliminary evidence of feasibility and benefits of yoga for PLWH.",2020,The yoga group improved over time in HRQoL cognition ( P = .047) with trends toward improvements in HRQoL health transition ( P =.063) and depression ( P = .055).,"['22 medically stable PLWH aged ≥35 years', 'People Living with HIV', 'people living with HIV (PLWH']","['Yoga Intervention', 'yoga intervention']","['Mean yoga class attendance', 'cognitive and physical function', 'HRQoL health transition', 'Cognition, Physical Function, Physical Activity, and Affective Outcomes', 'time in HRQoL cognition', 'cognition, physical function, medication adherence, health-related quality of life (HRQoL), and mental health', 'depression']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376627', 'cui_str': 'Health Transition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",22.0,0.106207,The yoga group improved over time in HRQoL cognition ( P = .047) with trends toward improvements in HRQoL health transition ( P =.063) and depression ( P = .055).,"[{'ForeName': 'Adria', 'Initials': 'A', 'LastName': 'Quigley', 'Affiliation': 'Department of Physiotherapy, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Marie-Josée', 'Initials': 'MJ', 'LastName': 'Brouillette', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Gahagan', 'Affiliation': 'School of Health and Human Performance, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Kelly Kathleen', 'Initials': 'KK', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Physiotherapy, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'MacKay-Lyons', 'Affiliation': 'Department of Physiotherapy, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",Journal of the International Association of Providers of AIDS Care,['10.1177/2325958220935698'] 2703,32473563,Exercise improves neurotrophins in multiple sclerosis independent of disability status.,"BACKGROUND To date, studies examining the effect of exercise on neurotrophic factors in MS are contradictory, and this may be explained, in part, by moderators such as disability status. To investigating the effect of a 12-week (3sessions/week) supervised multimodal exercise program on neurotrophic factors levels. METHODS Ninety four women with MS were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS< 4.5), moderate (4.5 ≤EDSS≤ 6), or high (EDSS≥ 6.5) disability. The exercise program comprised resistance, endurance, Pilates, balance and stretch exercises. Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI) were evaluated before and after the intervention period. RESULTS Exercise training improved brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels. The effect of exercise on NT-3 was dependent on disability status such that exercise groups with low and high disability had more pronounced changes compared with other condition. There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF). Aerobic capacity and one-repetition maximum, but not PCI, were improved with exercise independent of disability status. CONCLUSIONS Exercise can stimulate neurotrophic production and secretion, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and its effect may not be moderated by disability status.",2020,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,['Ninety four women with MS'],"['Exercise', 'Exercise training', 'multimodal exercise program', 'exercise program comprised resistance, endurance, Pilates, balance and stretch exercises']","['Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI', 'ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF', 'brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels', 'Disability Status Scale (EDSS) scores', 'Aerobic capacity and one-repetition maximum']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0207071', 'cui_str': 'Ciliary Neuronotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0199456,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Performance and Health, Institute for Sport and Sport Science, Technical University Dortmund, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102143'] 2704,32473644,Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial.,"BACKGROUND Coronary artery diseases (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure. Available neurohumoral treatment strategies aim at the improvement of symptoms. Despite extensive research, therapeutic options for myocardial regeneration, including (stem)-cell therapy, gene therapy, cellular reprogramming or tissue engineering, remain purely experimental. Thus, there is an urgent clinical need for novel treatment options for inducing myocardial regeneration and improving left-ventricular function in ischemic cardiomyopathy. Shockwave Therapy (SWT) is a well-established regenerative tool that is effective for the treatment of chronic tendonitis, long-bone non-union and wound-healing disorders. In preclinical trials, SWT regenerated ischemic myocardium via the induction of angiogenesis and the reduction of fibrotic scar tissue, resulting in improved left-ventricular function. METHODS/DESIGN In this prospective, randomized controlled, single-blind, monocentric study, 80 patients with reduced left-ventricular ejection fraction (LVEF≤ 40%) are subjected to coronary-artery bypass-graft surgery (CABG) surgery and randomized in a 1:1 ratio to receive additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment (control group; 40 patients). This study aims to evaluate (1) the safety and (2) the efficacy of cardiac SWT as adjunctive treatment during CABG surgery for the regeneration of ischemic myocardium. The primary endpoints of the study represent (1) major cardiac events and (2) changes in left-ventricular function 12 months after treatment. Secondary endpoints include 6-min Walk Test distance, improvement of symptoms and assessment of quality of life. DISCUSSION This study aims to investigate the safety and efficacy of cardiac SWT during CABG surgery for myocardial regeneration. The induction of angiogenesis, decrease of fibrotic scar tissue formation and, thus, improvement of left-ventricular function could lead to improved quality of life and prognosis for patients with ischemic heart failure. Thus, it could become the first clinically available treatment strategy for the regeneration of ischemic myocardium alleviating the socio-economic burden of heart failure. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03859466. Registered on 1 March 2019.",2020,Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure.,"['80 patients with reduced left-ventricular ejection fraction (LVEF≤\u200940', 'patients with ischemic heart failure', 'patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial']","['Shockwave Therapy (SWT', 'coronary-artery bypass-graft surgery (CABG) surgery', 'cardiac SWT', 'direct Cardiac Shockwave Therapy', 'additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment']","['fibrotic scar tissue formation', 'study represent (1) major cardiac events and (2) changes in left-ventricular function', '6-min Walk Test distance, improvement of symptoms and assessment of quality of life', 'quality of life and prognosis', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0241158', 'cui_str': 'Scar of skin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.112858,Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure.,"[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pölzl', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Nägele', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Graber', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hirsch', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Lobenwein', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mitrovic', 'Affiliation': 'Clinical Trial Center, Medical University of Innsbruck, Innrain 52, 6020, Innsbruck, Austria.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'University Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Theurl', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schreinlechner', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Pamminger', 'Affiliation': 'University Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dorfmüller', 'Affiliation': 'Heart Regeneration Technologies GmbH, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grimm', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Gollmann-Tepeköylü', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Holfeld', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Johannes.holfeld@i-med.ac.at.'}]",Trials,['10.1186/s13063-020-04369-0'] 2705,32475048,Effect of High-Intensity Interval Training on Visceral and Liver Fat in Cardiac Rehabilitation: A Randomized Controlled Trial.,"OBJECTIVE This study aimed to investigate the effect of exercise intensity on visceral adipose tissue (VAT) and liver fat reduction in patients with coronary artery disease (CAD) over 3 months and the maintenance of improvements over 12 months. METHODS Forty-two participants with CAD were randomized to three sessions/week of either 4 × 4-minute high-intensity interval training (HIIT) or 40 minutes of usual care moderate-intensity continuous training (MICT) for a 4-week supervised cardiac rehabilitation program, followed by three home-based sessions/week for 11 months. Liver fat (as intrahepatic lipid) and VAT were measured via magnetic resonance techniques. Data are mean change (95% CI). RESULTS HIIT and MICT significantly reduced VAT over 3 months (-350 [-548 to -153] cm 3 vs. -456 [-634 to -278] cm 3 ; time × group effect: P = 0.421), with further improvement over 12 months (-545 [-818 to -271] cm 3 vs. -521 [-784 to -258] cm 3 ; time × group effect: P = 0.577) and no differences between groups. Both groups improved liver fat over 3 months, with HIIT tending to show greater reduction than MICT (-2.8% [-4.0% to -1.6%] vs. -1.4% [-2.4% to -0.4%]; time × group effect: P = 0.077). After 12 months, improvements were maintained to a similar degree. Higher exercise intensity predicted liver fat reduction (β = -0.3 [-0.7 to 0.0]; P = 0.042). CONCLUSIONS HIIT and MICT reduced VAT over 3 and 12 months. For liver fat, HIIT tended to provide a slightly greater reduction compared with MICT. These findings support HIIT as a beneficial adjunct or alternative to MICT for reducing visceral and liver fat in patients with CAD.",2020,"RESULTS HIIT and MICT significantly reduced VAT over 3 months (-350 [-548 to -153]","['Forty-two participants with CAD', 'Cardiac Rehabilitation', 'patients with CAD', 'patients with coronary artery disease (CAD']","['exercise intensity', 'High-Intensity Interval Training', '4\u2009×\u20094-minute high-intensity interval training (HIIT) or 40 minutes of usual care moderate-intensity continuous training (MICT']","['VAT', 'Liver fat (as intrahepatic lipid) and VAT', 'liver fat', 'visceral adipose tissue (VAT) and liver fat reduction', 'Visceral and Liver Fat']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}]",42.0,0.032867,"RESULTS HIIT and MICT significantly reduced VAT over 3 months (-350 [-548 to -153]","[{'ForeName': 'Jenna L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Holland', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Gregore I', 'Initials': 'GI', 'LastName': 'Mielke', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Bailey', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Leveritt', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sjaan R', 'Initials': 'SR', 'LastName': 'Gomersall', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alex V', 'Initials': 'AV', 'LastName': 'Rowlands', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22833'] 2706,32475989,A randomized placebo-controlled PET study of ketamine´s effect on serotonin 1B receptor binding in patients with SSRI-resistant depression.,"The glutamate N-methyl-D-aspartate receptor antagonist ketamine has a rapid antidepressant effect. Despite large research efforts, ketamine's mechanism of action in major depressive disorder (MDD) has still not been determined. In rodents, the antidepressant properties of ketamine were found to be dependent on both the α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) and the serotonin (5-HT) 1B receptor. Low 5-HT 1B receptor binding in limbic brain regions is a replicated finding in MDD. In non-human primates, AMPA-dependent increase in 5-HT 1B receptor binding in the ventral striatum (VST) has been demonstrated after ketamine infusion. Thirty selective serotonin reuptake inhibitor-resistant MDD patients were recruited via advertisement and randomized to double-blind monotherapy with 0.5 mg/kg ketamine or placebo infusion. The patients were examined with the 5-HT 1B receptor selective radioligand [ 11 C]AZ10419369 and positron emission tomography (PET) before and 24-72 h after treatment. 5-HT 1B receptor binding did not significantly alter in patients treated with ketamine compared with placebo. An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment. 5-HT 1B receptor binding in VST at baseline correlated with MDD symptom ratings (r = -0.426, p = 0.019) and with reduction of depressive symptoms with ketamine (r = -0.644, p = 0.002). In conclusion, reduction of depressive symptoms in MDD patients after ketamine treatment is correlated inversely with baseline 5-HT 1B receptor binding in VST. Further studies examining the role of 5-HT 1B receptors in the antidepressant mechanism of action of ketamine should be conducted, homing in on the 5-HT 1B receptor as an MDD treatment response marker.",2020,An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment.,"['Thirty selective serotonin reuptake inhibitor-resistant MDD patients', 'patients with SSRI-resistant depression']","['glutamate N-methyl-D-aspartate receptor antagonist ketamine', 'ketamine', 'ketamine or placebo infusion', 'placebo']","['MDD symptom ratings', 'depressive symptoms', '5-HT 1B receptor binding']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0535025', 'cui_str': '5-HT1B Receptor'}]",30.0,0.0756628,An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment.,"[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Tiger', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden. mikael.tiger@ki.se.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Veldman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Ekman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Halldin', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lundberg', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}]",Translational psychiatry,['10.1038/s41398-020-0844-4'] 2707,32482534,"""Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial"".","BACKGROUND Adjuvant treatment for stage II colon cancer remains debated. Finding a tool to select patients at risk for disease recurrence may help the clinical decision. Circulating tumor DNA (ctDNA) has been reported recently as a potential predictive marker for disease recurrence. We thus aim to test its ability to better select stage II colon cancer patients for adjuvant therapy. METHODS This national, phase III trial (NCT00002019-000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients. Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma will be randomized within 63 days after curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²) every two weeks for 12 cycles or observation. Patients will be followed for maximum 7 years. A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test]; 1-β, 80%). Secondary endpoints include 2-yr DFS, overall survival, and toxicity. Recruitement began End of January 2020.",2020,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","['Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma', '000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients', 'stage II colon cancer', 'stage II colon cancer patients for adjuvant therapy', 'stage II colon cancer based on circulating tumor DNA']","['curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²']","['survival (DFS', '2-yr DFS, overall survival, and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332393', 'cui_str': 'pT3 category'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.265571,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taïeb', 'Affiliation': 'Department of gastroenterology and GI Oncology, Georges-Pompidou European Hospital, AP-HP; Sorbonne Paris cité, Université de Paris, Paris, France. Electronic address: jtaieb75@gmail.com.'}, {'ForeName': 'Léonor', 'Initials': 'L', 'LastName': 'Benhaim', 'Affiliation': 'Département de chirurgie viscérale oncologique, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent Puig', 'Affiliation': 'Pole biologie, Hospital European George Pompidou, Paris, Île-de-France, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'EA4340, Ambroise Pare Hospital, Beuvry, Hauts-de-France, France.'}, {'ForeName': 'Flore', 'Initials': 'F', 'LastName': 'Geillon', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Manfredi', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Chauvenet', 'Affiliation': 'Department of Gastroenterology, Groupement hospitalier Sud, Hospices civils de Lyon, Pierre Bénite, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Taly', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Department of digestive oncology University hospital Dijon; University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Sorbonne Université and Hôpital Saint Antoine, Paris, France.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.04.010'] 2708,32483147,"Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula.","Mother's milk is the best choice for infants nutrition, however when it is not available or insufficient to satisfy the needs of the infant, formula is proposed as an effective substitute. Here, we report the results of a randomized controlled clinical trial (NCT03637894) designed to evaluate the effects of two different dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula) versus breastfeeding (reference group) on immune defense mechanisms (primary endpoint: secretory IgA, antimicrobial peptides), the microbiota and its metabolome (secondary outcomes), in healthy full term infants according to the type of delivery (n = 13/group). We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk. Metabolome analysis allowed us to distinguish subjects based on their dietary regimen and mode of delivery. Together, these results suggest that a fermented formula favors the maturation of the immune system, microbiota and metabolome.",2020,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.",['healthy full term infants according to the type of delivery (n\u2009=\u200913/group'],"['Lactobacillus paracasei CBA', 'dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula']","['secretory IgA', 'safe and well tolerated']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}]",,0.03072,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Roggero', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy. paola.roggero@unimi.it.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Liotto', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pozzi', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Braga', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Troisi', 'Affiliation': 'Theoreo Srl, Via degli Ulivi 3, 84090, Montecorvino Pugliano, SA, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Menis', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria Lorella', 'Initials': 'ML', 'LastName': 'Giannì', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berni Canani', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Paparo', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nocerino', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Budelli', 'Affiliation': 'School of Engineering, Niccoló Cusano University, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rescigno', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. maria.rescigno@hunimed.eu.'}]",Nature communications,['10.1038/s41467-020-16582-1'] 2709,32484534,"Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia: A Randomized Clinical Trial.","Importance Antibiotic overuse drives antibiotic resistance. Gram-negative bacteremia is a common infection that results in substantial antibiotic use. Objective To compare the clinical effectiveness of C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations 30, 60, and 90 days after treatment initiation. Design, Setting, and Participants Multicenter, noninferiority, point-of-care randomized clinical trial including adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019. Patients and physicians were blinded between randomization and antibiotic discontinuation. Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression. Intervention Randomization in a 1:1:1 ratio to an individualized CRP-guided antibiotic treatment duration (discontinuation once CRP declined by 75% from peak; n = 170), fixed 7-day treatment duration (n = 169), or fixed 14-day treatment duration (n = 165). Main Outcomes and Measures The primary outcome was the clinical failure rate at day 30, defined as the presence of at least 1 of the following, with a non-inferiority margin of 10%: recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause. Secondary outcomes included the clinical failure rate on day 90 of follow-up. Results Among 504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up. Median antibiotic duration in the CRP group was 7 (interquartile range, 6-10; range, 5-28) days; 34 of the 164 patients (21%) who completed the 30-day follow-up had protocol violations related to treatment assignment. The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001). By day 90, clinical failure occurred in 10 of 143 patients (7.0%) in the CRP group, 16 of 151 (10.6%) in the 7-day group, and 16 of 153 (10.5%) in the 14-day group. Conclusions and Relevance Among adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment were noninferior to fixed 14-day treatment. However, interpretation is limited by the large noninferiority margin compared with the low observed event rate, as well as low adherence and wide range of treatment durations in the CRP-guided group. Trial Registration ClinicalTrials.gov Identifier: NCT03101072.",2020,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","['Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression', 'With Uncomplicated Gram-Negative Bacteremia', 'Patients', 'adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019', 'adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment', '504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up']","['individualized CRP-guided antibiotic treatment duration (discontinuation once CRP', 'C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations', 'C-Reactive Protein-Guided Antibiotic']","['clinical failure rate', 'Median antibiotic duration', 'clinical failure rate on day 90 of follow-up', '30-Day Clinical Failure Rate', 'recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause', 'clinical failure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C3160894', 'cui_str': 'Complicated infection'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C3203360', 'cui_str': 'Suppuration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",504.0,0.162586,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'von Dach', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Werner C', 'Initials': 'WC', 'LastName': 'Albrich', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Brunel', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Prendki', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Cuvelier', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Flury', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Gayet-Ageron', 'Affiliation': 'Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lemmenmeier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'McCallin', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rossel', 'Affiliation': 'Department of Internal Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Bochud', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}]",JAMA,['10.1001/jama.2020.6348'] 2710,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression. METHOD A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression. RESULTS A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001). CONCLUSION These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145'] 2711,32481262,"Radiological diagnostic accuracy study comparing Lenke, Bridwell, BSF, and CT-HU fusion grading scales for minimally invasive lumbar interbody fusion spine surgery and its correlation to clinical outcome.","Prospective randomized double-blinded diagnostic accuracy study about radiological grading of fusion after minimally invasive lumbar interbody fusion procedures (MI-LIFP).To determinate the intra and the inter-observer correlation between different radiological lumbar interbody fusion grading scales (RLIFGS) in patients undergoing MI-LIFP and their correlation to clinical outcome.Besides technological improvements in medical diagnosis and the many existing RLIFGS, surgical exploration continues to be the gold-standard to assess fusion in patients with radiological pseudarthrosis, with little if any research on the relationship between RLIFGS and clinical outcome.We collected data from patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score preoperatively and at the end of follow-up. Interbody fusion levels were coded for blinded evaluation by three different minimally invasive spine (MIS) surgeons, using Lenke, Bridwell, BSF (Brantigan, Steffe, Fraser), and CT-HU RLIFGS. We established fusion criteria, as described in their original papers. Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis. Radiological and clinical data was coded and statistically analyzed using Student T-Test, Pearson P-Test, and ANOVA with statistical package for the social sciences 21 by another blinded researcher, positive and negative predictive values were also calculated for each RLFGS.We found a significant clinical improvement with a moderate intra-observer correlation between scales and no inter-observer or clinical correlation, with no sub-group statistically significant differences.This paper represents the first study about the diagnostic accuracy of RLFGS, we concluded that their diagnostic accuracy is pretty low to determine fusion or pseudoarthrosis based on its low correlation to clinical outcome, we recommend surgeons rely on clinical findings to decide whether a patient has clinical fusion or pseudoarthrosis based on successful clinical outcome.",2020,"Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis.","['patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose', 'patients undergoing MI-LIFP and their correlation to clinical outcome', 'patients with radiological pseudarthrosis']","['Lenke, Bridwell, BSF, and CT-HU fusion grading scales', 'RLFGS']","['successful clinical outcome (SCO', 'L-VAS, R-VAS, or ODI score', 'clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1293131', 'cui_str': 'Fusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033785', 'cui_str': 'Pseudoarthrosis'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0349849,"Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis.","[{'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Soriano Sánchez', 'Affiliation': 'Spine Clinic of The American-British Cowdray Medical Center IAP. Campus Santa Fe Mexican Association of Spine Surgeons (AMCICO) Mexican Society of Neurological Surgery (SMCN).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Soriano Solís', 'Affiliation': 'Orthopedic Surgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Manuel Eduardo', 'Initials': 'ME', 'LastName': 'Soto García', 'Affiliation': 'Neurosurgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Héctor Antonio', 'Initials': 'HA', 'LastName': 'Soriano Solís', 'Affiliation': 'Orthopedic Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Briscia Yazmin Aranda', 'Initials': 'BYA', 'LastName': 'Torres', 'Affiliation': 'Student of Nutritional Sciences, University of Sonora (UNISON).'}, {'ForeName': 'José Alberto Israel', 'Initials': 'JAI', 'LastName': 'Romero Rangel', 'Affiliation': 'Neurosurgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP. Campus Santa Fe Neurosurgeon of the Regional General Hospital #25, Mexican Institute of Social Security (HGR#25, IMSS).'}]",Medicine,['10.1097/MD.0000000000019979'] 2712,32481275,Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE): A protocol of a randomized controlled trial for chronic musculoskeletal pain in cancer survivors.,"INTRODUCTION Chronic pain is a leading cause of disability and remains under-treated in nearly half of patients with cancer. The opioid crisis has highlighted an urgent public health need for effective nonpharmacological pain management. Electroacupuncture (EA) and Battlefield Acupuncture (BFA) represent nonpharmacological modalities used in clinical practice to manage pain; however, their effectiveness has not been rigorously evaluated in oncology settings. METHODS We describe the design of a 3-arm, parallel, single-center, multisite randomized controlled trial that investigates EA and BFA versus usual-care wait-list control (WLC) for chronic musculoskeletal pain among 360 patients with diverse cancer types across various stages. The primary aim is to compare effects of EA and BFA versus WLC on pain, physical function, and co-morbid symptoms. The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction. The tertiary aim is to evaluate the association between genetic polymorphisms and responses to acupuncture. Patients will be randomized in a 2:2:1 ratio to EA:BFA:WLC. Acupuncture groups will receive weekly treatments over 10 weeks. WLC will receive usual care over the same evaluation period as the acupuncture groups. The primary endpoint will be the change in average pain intensity score from baseline to week 12. We will collect validated patient-reported outcomes and blood/saliva samples at multiple timepoints over 24 weeks. DISCUSSION Our findings will advance nonpharmacological pain management in oncology and inform personalized treatment approaches that integrate individuals' expectations and genetic biomarkers to deliver ""precision"" acupuncture to cancer patients with chronic pain. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02979574.",2020,The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction.,"['360 patients with diverse cancer types across various stages', 'chronic musculoskeletal pain in cancer survivors', 'cancer patients with chronic pain', 'patients with cancer']","['acupuncture', 'EA and BFA versus usual-care wait-list control (WLC', 'EA and BFA versus WLC', 'Acupuncture', 'acupuncture modality (EA vs BFA', 'Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE', 'Electroacupuncture (EA) and Battlefield Acupuncture (BFA', 'WLC']","['average pain intensity score', 'pain reduction', 'pain, physical function, and co-morbid symptoms']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",360.0,0.192384,The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction.,"[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Liou', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Baser', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Sally A D', 'Initials': 'SAD', 'LastName': 'Romero', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego School of Medicine, San Diego, CA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Q Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Orlow', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Panageas', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}]",Medicine,['10.1097/MD.0000000000020085'] 2713,32485550,Effects of couple conflict on alcohol craving: Does intimate partner violence play a role?,"OBJECTIVE Social stress in the form of maladaptive relationship conflict is a common precipitant to alcohol misuse and problems. Research has also established a clear causal association between alcohol misuse and relationship conflict in the form of intimate partner violence (IPV). Despite the robust literature linking relationship conflict and problematic drinking using survey methodology, no laboratory studies have examined the proximal association between relationship conflict and alcohol craving among couples, or the influence of IPV perpetration and victimization on this association. METHOD As part of a larger randomized controlled trial, 30 different-sex community couples with substance misuse completed a laboratory conflict resolution task. Participants reported subjective alcohol craving on a Likert-type scale immediately, before, and after the task. Conflict behaviors were coded by trained observers. Analyses were conducted using a multilevel modeling framework to account for the dyadic nature of the data. RESULTS Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only. Contrary to our hypotheses, no main or moderating effects of conflict behaviors, IPV perpetration, or IPV victimization were found for women. CONCLUSIONS Findings from this exploratory study suggest that in this sample, relationship conflict and IPV in one's current relationship played a more impactful role on acute alcohol craving among men compared to women. Future studies should examine the role of specific conflict behaviors on alcohol craving and relapse risk, and patterns of communication that might increase or reduce risk for exacerbated alcohol craving.",2020,"RESULTS Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.",['30 different-sex community couples with substance misuse completed a laboratory conflict resolution task'],['couple conflict'],"['subjective alcohol craving', 'negative and positive conflict behaviors and alcohol craving', 'conflict behaviors, IPV perpetration, or IPV victimization', 'acute alcohol craving', 'alcohol craving', 'Conflict behaviors']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0159769,"RESULTS Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, United States. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States.'}, {'ForeName': 'Ruschelle M', 'Initials': 'RM', 'LastName': 'Leone', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Oesterle', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106474'] 2714,32485622,Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial.,"OBJECTIVE To demonstrate the effectiveness of a cognitive behavioural therapy for stress management in pregnant women in the reduction of psychological stress and hair cortisol levels. METHODS The trial was controlled and randomised, with a total of 78 pregnant women: control group (n-39) and Cognitive Behavioural Therapy group (n-39). To test the therapy's efficacy, an evaluation of the primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience) was conducted before and after the treatment. The therapy was conducted during 8 sessions (one per week) in a group setting. The study was registered as a Randomised Controlled Trial with the code NCT03404141. RESULTS The results showed a group time interaction between hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms. These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. CONCLUSIONS Using a novel way of assessing chronic stress (psychological and objective measures as hair cortisol levels), this is the first study that has shown a decrease in both the levels of cortisol in hair and in psychological stress. This decline could have implications for maternal and fetal health.",2020,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. ","['78 pregnant women', 'pregnant women in the reduction of psychological stress and hair cortisol levels', 'pregnant women']","['cognitive behavioural therapy', 'cognitive-behavioural therapy', 'control group (n-39) and Cognitive Behavioural Therapy group (n-39']","['hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms', 'primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience', 'stress and hair cortisol levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",78.0,0.0699261,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. ","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Strivens-Vilchez', 'Affiliation': 'Midwifery Department, Gongora Primary Health Center, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitariaibs.GRANADA, University of Granada, Granada, Spain. Electronic address: raquel.gonzalez@ciberehd.org.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110162'] 2715,32485633,Effect of hippotherapy on walking performance and gait parameters in people with multiple sclerosis.,"BACKGROUND Walking dysfunction is one of the most common symptoms of multiple sclerosis (MS). OBJECTIVE To evaluate the effects of an 8-week hippotherapy intervention on walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS; and to examine whether the effects of hippotherapy on walking performance are mediated by changes in spatiotemporal gait parameters. METHODS Participants were assigned into a hippotherapy intervention group (n = 17) or a control group (n = 16). The intervention included 16 sessions of 30-minutes of hippotherapy conducted twice a week. Participants underwent the 25-foot walk test (T25FW) and 6-minute walk test (6MWT), as primary outcomes, and spatiotemporal gait evaluation using GaitRite system, as secondary outcomes, before and after intervention. The data were examined using mixed model ANOVA with Bonferroni post hoc. Mediation analysis was conducted as per Baron and Kenny's criteria. RESULTS Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control. Only balance time (p = 0.043), stance time (p = 0.031), and absolute (p = 0.004) and relative (p = 0.017) double support time were identified as significant mediators of the effects of hippotherapy on walking performance evaluated by T25FW. There was no significant mediator for 6MWT (all p>0.05). CONCLUSION Hippotherapy improved walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS, and changes in walking performance, evaluated by T25FW, were partially driven by reduction in stance time and double support time and increase in balance time. Hippotherapy may be a useful complimentary treatment approach for improving walking in people with MS.",2020,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","['people with relapsing-remitting MS', 'people with multiple sclerosis', 'Participants', 'people with MS']","['hippotherapy intervention', 'Hippotherapy', 'hippotherapy', '25-foot walk test (T25FW) and 6-minute walk test (6MWT']","['T25FW time', 'walking performance and spatiotemporal gait parameters', '6MWT distance', 'walking performance and gait parameters', 'stance time', 'balance time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0352318,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","[{'ForeName': 'Andréa Gomes', 'Initials': 'AG', 'LastName': 'Moraes', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil. Electronic address: deyafisio9@hotmail.com.'}, {'ForeName': 'Silvia Gonçalves Ricci', 'Initials': 'SGR', 'LastName': 'Neri', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham,Birmingham, AL, United States.'}, {'ForeName': 'Carlos Bernardo', 'Initials': 'CB', 'LastName': 'Tauil', 'Affiliation': 'Faculty of Medicine, University of Brasília, DF, Brazil.'}, {'ForeName': 'Felipe von', 'Initials': 'FV', 'LastName': 'Glehn', 'Affiliation': 'Department of Medical Clinic, Faculty of Medicine, University of Brasilia, Brasilia, DF and Department of Immunology, University of Unicamp, SP, Brazil.'}, {'ForeName': 'Éber Castro', 'Initials': 'ÉC', 'LastName': 'Corrêa', 'Affiliation': 'Clinen, Neurology and Endocrinology Clinic, Brasília, DF, Bazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'de David', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102203'] 2716,32485640,Improving B-mode ultrasound diagnostic performance for focal liver lesions using deep learning: A multicentre study.,"BACKGROUND The diagnosis performance of B-mode ultrasound (US) for focal liver lesions (FLLs) is relatively limited. We aimed to develop a deep convolutional neural network of US (DCNN-US) for aiding radiologists in classification of malignant from benign FLLs. MATERIALS AND METHODS This study was conducted in 13 hospitals and finally 2143 patients with 24,343 US images were enrolled. Patients who had non-cystic FLLs with pathological results were enrolled. The FLLs from 11 hospitals were randomly divided into training and internal validations (IV) cohorts with a 4:1 ratio for developing and evaluating DCNN-US. Diagnostic performance of the model was verified using external validation (EV) cohort from another two hospitals. The diagnosis value of DCNN-US was compared with that of contrast enhanced computed tomography (CT)/magnetic resonance image (MRI) and 236 radiologists, respectively. FINDINGS The AUC of Model LBC for FLLs was 0.924 (95% CI: 0.889-0.959) in the EV cohort. The diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists (86.5% vs 76.1%, p = 0.0084 and 85.5% vs 76.9%, p = 0.0051, respectively). Accuracy of Model LBC was comparable to that of contrast enhanced CT (both 84.7%) but inferior to contrast enhanced MRI (87.9%) for lesions detected by US. INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.",2020,"INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","['focal liver lesions using deep learning', '11 hospitals', '13 hospitals and finally 2143 patients with 24,343 US images were enrolled', 'Patients who had non-cystic FLLs with pathological results were enrolled']",['deep convolutional neural network of US (DCNN-US'],"['AUC of Model LBC for FLLs', 'Diagnostic performance', 'diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists']","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1318045', 'cui_str': 'AKAP13 protein, human'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]",2143.0,0.0256485,"INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Centers for Biomedical Engineering, University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'School of Mathematical Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Tianan', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, the First Affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, Jiangsu, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasound Diagnosis, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Harbin The First Hospital, Harbin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Ultrasound, Ma'anshan People's Hospital, Ma'anshan, China.""}, {'ForeName': 'Jintang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic Ultrasound, Xiangya Hospital, Changsha, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Central Theater Command General Hospital, Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Diagnostic Ultrasound, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ultrasound, Fujian Cancer Hospital&Fujian Medical University Cancer Hospita, Fuzhou, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhengrq@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: jiemi301@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine, Beihang University, Beijing, China. Electronic address: jie.tian@ia.ac.cn.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: liangping301@hotmail.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102777'] 2717,32580577,"Effectiveness of four types of bandages and kinesio-tape for treating breast-cancer-related lymphoedema: a randomized, single-blind, clinical trial.","OBJECTIVE To compare the effects of four types of bandages and kinesio-tape and determine which one is the most effective in women with unilateral breast cancer-related lymphoedema. DESIGN Randomized, single-blind, clinical trial. SETTING Physiotherapy department in the Women's Health Research Group at the University of Alcalá, Madrid, Spain. SUBJECTS A total of 150 women presenting breast-cancer-related lymphoedema. INTERVENTIONS Participants were randomized into five groups ( n  = 30). All women received an intensive phase of complex decongestive physiotherapy including manual lymphatic drainage, pneumatic compression therapy, therapeutic education, active therapeutic exercise and bandaging. The only difference between the groups was the bandage or tape applied (multilayer; simplified multilayer; cohesive; adhesive; kinesio-tape). MAIN MEASUREMENTS The main outcome was percentage excess volume change. Other outcomes measured were heaviness and tightness symptoms, and bandage or tape perceived comfort. Data were collected at baseline and finishing interventions. RESULTS This study showed significant differences between the bandage groups in absolute value of excess volume ( P  < 0.001). The most effective were the simplified multilayer (59.5%, IQR = 28.7) and the cohesive bandages (46.3%, IQR = 39). The bandages/tape with the least difference were kinesio-tape (4.9%, IQR = 17.7) and adhesive bandage (21.7%, IQR = 17.9). The five groups exhibited a significant decrease in symptoms after interventions, with no differences between groups. In addition, kinesio-tape was perceived as the most comfortable by women and multilayer as the most uncomfortable ( P  < 0.001). CONCLUSION Simplified multilayer seems more effective and more comfortable than multilayer bandage. Cohesive bandage seems as effective as simplified multilayer and multilayer bandage. Kinesio taping seems the least effective.",2020,"The only difference between the groups was the bandage or tape applied (multilayer; simplified multilayer; cohesive; adhesive; kinesio-tape). ","['women with unilateral breast cancer-related lymphoedema', 'A total of 150 women presenting breast-cancer-related lymphoedema', ""Physiotherapy department in the Women's Health Research Group at the University of Alcalá, Madrid, Spain"", 'treating breast-cancer-related lymphoedema']","['complex decongestive physiotherapy including manual lymphatic drainage, pneumatic compression therapy, therapeutic education, active therapeutic exercise and bandaging', 'Kinesio taping', 'bandages and kinesio-tape']","['adhesive bandage', 'symptoms', 'heaviness and tightness symptoms, and bandage or tape perceived comfort', 'kinesio-tape', 'percentage excess volume change']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4018978', 'cui_str': 'Unilateral Breast Cancer'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C1167944', 'cui_str': 'Pneumatic compression therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}]","[{'cui': 'C0001512', 'cui_str': 'Adhesive bandage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",150.0,0.0816891,"The only difference between the groups was the bandage or tape applied (multilayer; simplified multilayer; cohesive; adhesive; kinesio-tape). ","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Torres-Lacomba', 'Affiliation': ""Physiotherapy Department, Physiotherapy in Women's Health Research Group, Faculty of Physiotherapy, University of Alcalá, Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Navarro-Brazález', 'Affiliation': ""Physiotherapy Department, Physiotherapy in Women's Health Research Group, Faculty of Physiotherapy, University of Alcalá, Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Prieto-Gómez', 'Affiliation': ""Physiotherapy Department, Physiotherapy in Women's Health Research Group, Faculty of Physiotherapy, University of Alcalá, Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Ferrandez', 'Affiliation': ""Physiotherapy Department, Physiotherapy in Women's Health Research Group, Faculty of Physiotherapy, University of Alcalá, Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'Jean Yves', 'Initials': 'JY', 'LastName': 'Bouchet', 'Affiliation': ""Physiotherapy Department, Physiotherapy in Women's Health Research Group, Faculty of Physiotherapy, University of Alcalá, Alcalá de Henares, Madrid, Spain.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Romay-Barrero', 'Affiliation': 'Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, Toledo, Spain.'}]",Clinical rehabilitation,['10.1177/0269215520935943'] 2718,32580579,Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial.,"Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain FGFR alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR -altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with FGFR2 translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients. Clinical Trial Registration: NCT03773302 (ClincalTrials.gov).",2020,Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR -altered cholangiocarcinomas has led to its further investigation in the front-line setting.,"['advanced/metastatic cholangiocarcinoma with FGFR2 translocations', 'patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations']",['care gemcitabine and cisplatin'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4087471', 'cui_str': 'Cholangiocarcinoma metastatic'}, {'cui': 'C0209706', 'cui_str': 'Fibroblast Growth Factor Receptor 2'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0178648', 'cui_str': 'Gene Fusion'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",[],,0.0744824,Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR -altered cholangiocarcinomas has led to its further investigation in the front-line setting.,"[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Makawita', 'Affiliation': 'Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'K Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY\xa010065, USA.'}, {'ForeName': 'Sameek', 'Initials': 'S', 'LastName': 'Roychowdhury', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, The James Cancer Hospital & Comprehensive Cancer Center, The Ohio State University, Columbus, OH\xa043210, USA.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, CA\xa090404, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'Department of Gastroenterology & Digestive Oncology, Cliniques Universitaires Saint-Luc & Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Cancer Center, Massachusetts General Hospital, Boston, MA\xa002114, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cohn', 'Affiliation': 'Rocky Mountain Cancer Center & US Oncology Research, Denver, CO\xa080218, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lamarca', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Division of Cancer Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology & IOB quirón, Barcelona, Spain.""}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'T Shroff', 'Affiliation': 'Division of Hematology/Oncology, University of Arizona Cancer Center, Tucson, AZ\xa085724, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Howland', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Cho', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Pande', 'Affiliation': 'QED Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Javle', 'Affiliation': 'Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, TX\xa077030, USA.'}]","Future oncology (London, England)",['10.2217/fon-2020-0299'] 2719,32580620,"The effect of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric parameters, body composition and angiogenesis factor, sirtunin-1 and peroxisome proliferator-activated receptor-γ coactivator-1α in obese people under a weight loss regime: A study protocol for a randomized controlled clinical trial.","BACKGROUND Obesity is defined as a chronic disease, and is known as a public health problem in developed and developing countries. Several studies have shown the effects of anti-obesity of α-lactalbumin. AIM This study was designed to investigate the effect of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric parameters, body composition and angiogenesis factor, sirtunin-1 and peroxisome proliferator-activated receptor-γ coactivator-1α (PGC1α) in obese people under a weight loss regime. METHODS Obese people who meet the inclusion criteria are included. Participants are randomly divided into four groups (alpha-lipoic (1200 mg) +weight loss regime group; Faradic (three 1 hour sessions) + weight loss regime group; alpha-lipoic (1200 mg) + Faradic (three 1 hour sessions) + weight loss regime group; control group (1200 mg placebo) for 2 months. At the beginning and the end of the study, demographic information, dietary intake, anthropometric parameters, body composition and serum levels of the angiogenesis factor (sirtunin-1, PGC1α and nitric oxide) are measured. CONCLUSION Recent studies reported the anti-obesity effects of alpha-lipoic acid. This study is novel, since a similar study has not yet been carried out. This study evaluates the effect of 600 mg of alpha-lipoic acid supplementation or having three sessions of 1 hour per week electrical isotonic contraction induced by Faradic for 2 months alone or in combination in obese people that are undergoing a weight loss regime. TRIAL REGISTRATION Iran Clinical Trials Registry, ID: IRCT20131117015424N2. Registered 2018-04-02.",2020,"At the beginning and the end of the study, demographic information, dietary intake, anthropometric parameters, body composition and serum levels of the angiogenesis factor (sirtunin-1, PGC1α and nitric oxide) are measured. ","['obese people under a weight loss regime', 'Obese people who meet the inclusion criteria are included', 'obese people that are undergoing a weight loss regime']","['alpha-lipoic acid supplementation', 'alpha-lipoic (1200 mg) +weight loss regime group; Faradic (three 1 hour sessions) + weight loss regime group; alpha-lipoic (1200 mg) + Faradic (three 1 hour sessions) + weight loss regime group; control group (1200 mg placebo', 'alpha-lipoic acid supplementation and electrical isotonic contraction', 'peroxisome proliferator-activated receptor-γ coactivator-1α']","['anthropometric parameters, body composition and angiogenesis factor, sirtunin-1 and peroxisome proliferator-activated receptor-γ coactivator-1α (PGC1α', 'demographic information, dietary intake, anthropometric parameters, body composition and serum levels of the angiogenesis factor (sirtunin-1, PGC1α and nitric oxide']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0022259', 'cui_str': 'Muscle isotonic contraction'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0002976', 'cui_str': 'Angiogenic Factor'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",,0.0806052,"At the beginning and the end of the study, demographic information, dietary intake, anthropometric parameters, body composition and serum levels of the angiogenesis factor (sirtunin-1, PGC1α and nitric oxide) are measured. ","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Zakizadeh', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ravanbakhsh', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Helli', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Iran.'}]",Nutrition and health,['10.1177/0260106020926838'] 2720,32580655,Comparison of Outcome Adjudication by Investigators and by a Central Endpoint Committee in Heart Failure Trials: Experience of the SHIFT Heart Failure Study.,"BACKGROUND The usefulness of adjudication by central end point committees (CECs) is poorly assessed in heart failure (HF) trials. We aimed to assess its impact on the outcome of the SHIFT trial (Systolic HF Treatment With the If Inhibitor Ivabradine Trial). METHODS SHIFT was a randomized placebo-controlled trial investigating the effect of ivabradine in 6505 HF patients with reduced ejection fraction. Prespecified end points, reported by investigators (all cardiologists) using specific case report form pages, included all-cause and specific causes of deaths and hospitalizations. The primary end point was a composite of cardiovascular deaths or hospitalizations for worsening HF. We compared the adjudication of prespecified end points made by investigators and by the CEC. RESULTS Investigators identified 7529 prespecified end points, 6793 of which were confirmed by the CEC: 98.1% of cardiovascular deaths, 88.6% of all hospitalizations, and 84.4% of hospitalizations for worsening HF. These differences had no meaningful impact on the study results; hazard ratio for the primary composite end point: investigators, 0.83 (95% CI, 0.76-0.91) versus CEC, 0.82 (95% CI, 0.75-0.90), with similar results for each component of the primary end point (hazard ratio of 0.92 versus 0.91 for cardiovascular death and 0.78 versus 0.74 for hospitalization for worsening HF). CONCLUSIONS Central adjudication by a CEC in the SHIFT study confirmed most of cardiovascular deaths and worsening HF hospitalizations assessed by cardiologists and did not result in a significant change of the final result as compared to investigator judgment. In this context, the benefits of CEC in blinded HF trials should be reconsidered. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT02441218. URL: http://www.isrctn.com/ISRCTN70429960; Unique identifier: ISRCTN70429960.",2020,"These differences had no meaningful impact on the study results; hazard ratio for the primary composite end point: investigators, 0.83",['6505 HF patients with reduced ejection fraction'],"['ivabradine', 'placebo']","['cardiovascular deaths', 'cardiovascular deaths and worsening HF hospitalizations', 'composite of cardiovascular deaths or hospitalizations for worsening HF']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",6505.0,0.254635,"These differences had no meaningful impact on the study results; hazard ratio for the primary composite end point: investigators, 0.83","[{'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tyl', 'Affiliation': 'CardioVascular & Metabolic Disease Center for Therapeutic Innovation, Institut de Recherches Internationales Servier, Suresnes, France. (B.T., C.V.).'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lopez Sendon', 'Affiliation': 'Cardiology Department, University Hospital La Paz, UAM, IdiPaz, CiberCV, Madrid, Spain. (J.L.S.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Borer', 'Affiliation': 'College of Medicine, School of Public Health, SUNY Downstate Medical Center, Brooklyn, New York (J.S.B.).'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Lopez De Sa', 'Affiliation': 'Acute Cardiac Care Unit, University Hospital La Paz, UAM, IdiPaz, CiberCV, Madrid, Spain. (E.L.D.S.).'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Lerebours', 'Affiliation': 'Health Value 92, Levallois-Perret, France (G.L.).'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Varin', 'Affiliation': 'CardioVascular & Metabolic Disease Center for Therapeutic Innovation, Institut de Recherches Internationales Servier, Suresnes, France. (B.T., C.V.).'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'De Montigny', 'Affiliation': 'Center of Excellence Methodology and Valorisation of Data, Institut de Recherches Internationales Servier, Suresnes, France. (A.D.M., M.P.).'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Pannaux', 'Affiliation': 'Center of Excellence Methodology and Valorisation of Data, Institut de Recherches Internationales Servier, Suresnes, France. (A.D.M., M.P.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Department of Cardiology, Hospital Saint Joseph, Paris, France (M.K.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006720'] 2721,32580666,Moderate endurance and muscle training is beneficial and safe in patients with quiescent or mildly active Crohn's disease.,"BACKGROUND AND AIMS Physical activity is beneficial in several chronic disorders including Crohn's disease, but the preferred type of exercise is unknown. Our study aimed to examine and compare the safety, feasibility and potential beneficial effects of individual moderate endurance and moderate muscle training in patients with Crohn's disease. METHODS Quiescent or mildly active (Crohn's disease activity index <220) patients with Crohn's disease were randomly allocated to either a control, endurance, or muscle training group. Participants exercised individually for 3 months three times per week. Endpoints included dropout rate, disease activity, inflammatory parameters including faecal calprotectin, anthropometric data, quality of life, physical activity and strength. RESULTS A total of 45 patients with Crohn's disease were randomly allocated. In the endurance group ( n  = 17), the dropout rate was significantly higher (47% vs. 13%) compared with the muscle group ( n  = 15). In both groups the maximal and average strength in the upper and lower extremities increased significantly (all P  < 0.04). In the endurance group emotional function was significantly improved ( P  = 0.03). Statistically significant changes of disease activity and other outcome parameters were not observed in this pilot cohort. CONCLUSION Both individual moderate endurance and muscle training can be safely performed in patients with mild or quiescent Crohn's disease. Muscle training appears more feasible and may be favoured. Both forms of exercise have beneficial effects on strength. Quality of life increased in both intervention groups, although statistical significance was only reached in one subgroup.",2020,In both groups the maximal and average strength in the upper and lower extremities increased significantly (all P  < 0.04).,"[""patients with Crohn's disease"", ""45 patients with Crohn's disease"", ""Quiescent or mildly active (Crohn's disease activity index"", ""220) patients with Crohn's disease"", ""patients with mild or quiescent Crohn's disease"", ""patients with quiescent or mildly active Crohn's disease""]","['individual moderate endurance and muscle training', 'individual moderate endurance and moderate muscle training', 'Muscle training', 'control, endurance, or muscle training group', 'Moderate endurance and muscle training']","['dropout rate', 'emotional function', 'disease activity', 'dropout rate, disease activity, inflammatory parameters including faecal calprotectin, anthropometric data, quality of life, physical activity and strength', 'Quality of life', 'maximal and average strength in the upper and lower extremities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",45.0,0.0320355,In both groups the maximal and average strength in the upper and lower extremities increased significantly (all P  < 0.04).,"[{'ForeName': 'Wolfgang Alexander', 'Initials': 'WA', 'LastName': 'Seeger', 'Affiliation': 'Department of Medicine I, Agaplesion Markus Hospital, Frankfurt, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Thieringer', 'Affiliation': 'Department of Medicine I, Agaplesion Markus Hospital, Frankfurt, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Esters', 'Affiliation': 'Department of Medicine I, Agaplesion Markus Hospital, Frankfurt, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Allmendinger', 'Affiliation': 'Department of Medicine I, Agaplesion Markus Hospital, Frankfurt, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Gastroenterology and Clinical Nutrition, Interdisziplinäres Crohn Colitis Centrum, Frankfurt, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Schulze', 'Affiliation': 'Department of Medicine I, Agaplesion Markus Hospital, Frankfurt, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Dignass', 'Affiliation': 'Department of Medicine I, Agaplesion Markus Hospital, Frankfurt, Germany.'}]",United European gastroenterology journal,['10.1177/2050640620936383'] 2722,32580739,"The impact of gravidity, symptomatology and timing of infection on placental malaria.","BACKGROUND Placental malaria is associated with increased risk of adverse perinatal outcomes. While primigravidity has been reported as a risk factor for placental malaria, little is known regarding the relationship between gravidity, symptomatology and timing of Plasmodium falciparum infection and the development of placental malaria. METHODS The aim of this study was to investigate the relationship between the development of placental malaria and gravidity, timing of infection, and presence of symptoms. This is a secondary analysis of data from a double-blind randomized control trial of intermittent preventive therapy during pregnancy in Uganda. Women were enrolled from 12 to 20 weeks gestation and followed through delivery. Exposure to malaria parasites was defined as symptomatic (fever with positive blood smear) or asymptomatic (based on molecular detection of parasitaemia done routinely every 4 weeks). The primary outcome was placental malaria diagnosed by histopathology, placental blood smear, and/or placental blood loop-mediated isothermal amplification. Multivariate analyses were performed using logistic regression models. Subgroup analysis was performed based on the presence of symptomatic malaria, gravidity, and timing of infection. RESULTS Of the 228 patients with documented maternal infection with malaria parasites during pregnancy, 101 (44.3%) had placental malaria. Primigravidity was strongly associated with placental malaria (aOR 8.90, 95% CI 4.34-18.2, p < 0.001), and each episode of malaria was associated with over a twofold increase in placental malaria (aOR 2.35, 95% CI 1.69-3.26, p < 0.001). Among multigravid women, the odds of placental malaria increased by 14% with each advancing week of gestation at first documented infection (aOR 1.14, 95% CI 1.02-1.27, p = 0.02). When stratified by the presence of symptoms, primigravidity was only associated with placental malaria in asymptomatic women, who had a 12-fold increase in the odds of placental malaria (aOR 12.19, 95% CI 5.23-28.43, p < 0.001). CONCLUSIONS Total number of P. falciparum infections in pregnancy is a significant predictor of placental malaria. The importance of timing of infection on the development of placental malaria varies based on gravidity. In primigravidas, earlier asymptomatic infections were more frequently identified in those with placental malaria, whereas in multigravidas, parasitaemias detected later in gestation were associated with placental malaria. Earlier initiation of an effective intermittent preventive therapy may help to prevent placental malaria and improve birth outcomes, particularly in primigravid women.",2020,"Primigravidity was strongly associated with placental malaria (aOR 8.90, 95% CI 4.34-18.2, p < 0.001), and each episode of malaria was associated with over a twofold increase in placental malaria (aOR 2.35, 95% CI 1.69-3.26, p < 0.001).","['228 patients with documented maternal infection with malaria parasites during pregnancy, 101 (44.3%) had placental malaria', 'pregnancy in Uganda', 'Women were enrolled from 12 to 20\xa0weeks gestation and followed through delivery']",['intermittent preventive therapy'],"['placental malaria and improve birth outcomes', 'placental malaria diagnosed by histopathology, placental blood smear, and/or placental blood loop-mediated isothermal amplification', 'placental malaria', 'placental malaria and gravidity, timing of infection, and presence of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0239997', 'cui_str': 'Maternal infection'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",228.0,0.148916,"Primigravidity was strongly associated with placental malaria (aOR 8.90, 95% CI 4.34-18.2, p < 0.001), and each episode of malaria was associated with over a twofold increase in placental malaria (aOR 2.35, 95% CI 1.69-3.26, p < 0.001).","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Tran', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics Gynecology & Reproductive Sciences, University of California San Francisco, 513 Parnassus Ave. HSE16, Box 0556, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Cheeks', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics Gynecology & Reproductive Sciences, University of California San Francisco, 513 Parnassus Ave. HSE16, Box 0556, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Muhindo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Nakalembe', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ategeka', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Nayebare', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Feeney', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Gaw', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics Gynecology & Reproductive Sciences, University of California San Francisco, 513 Parnassus Ave. HSE16, Box 0556, San Francisco, CA, 94143, USA. stephanie.gaw@ucsf.edu.'}]",Malaria journal,['10.1186/s12936-020-03297-3'] 2723,32580752,Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial.,"BACKGROUND Currently, coronavirus disease 2019 (COVID-19) is continuously and rapidly circulating, causing heavy damage on public health. No effective antiviral treatment has been proved thus far. Traditional Chinese medicine (TCM) has been widely applied in the treatment of a variety of infection diseases in China, hoping to produce clinical effects and reduce the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Shenhuang granule in treatment of severe COVID-19. METHODS/DESIGN This multicenter, open-label randomized controlled trial is conducted in 160 participants with severe COVID-19. The participants will be randomly (1:1) divided into treatment group or control group. All participants are given standard therapy at the same time. The experiment will receive Shenhuang granule treatment twice a day for 14 days. The clinical indicators of patients will be assessed at baseline and at 3, 5, 7, and 14 days after treatment initiation. The primary outcome is 14-day clinical outcome. Adverse events will be monitored throughout the trial. DISCUSSION This will be the first randomized controlled trial, which evaluate the effect of Shenhuang granule in patients with severe COVID-19 in China. The results of this trial may not only provide evidence-based recommendations to clinicians to treat severe COVID-19, but also enrich the theory and practice of TCM in treating infectious diseases. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR2000029777. Registered on 13 February 2020.",2020,"The clinical indicators of patients will be assessed at baseline and at 3, 5, 7, and 14 days after treatment initiation.","['patients with severe COVID-19 in China', '160 participants with severe COVID-19']",['Traditional Chinese medicine (TCM'],"['efficacy and safety', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",160.0,0.157219,"The clinical indicators of patients will be assessed at baseline and at 3, 5, 7, and 14 days after treatment initiation.","[{'ForeName': 'Bangjiang', 'Initials': 'B', 'LastName': 'Fang', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Tingrong', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Huangshi Hospital of TCM (Infectious Disease Hospital), NO.6 Plaza Road, Huangshi Port District, Huangshi, 435000, Hubei, China.'}, {'ForeName': 'Huacheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Huangshi Hospital of TCM (Infectious Disease Hospital), NO.6 Plaza Road, Huangshi Port District, Huangshi, 435000, Hubei, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Huangshi Hospital of TCM (Infectious Disease Hospital), NO.6 Plaza Road, Huangshi Port District, Huangshi, 435000, Hubei, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Che', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Clinical Medical College of TCM, Hubei University of Chinese Medicine, NO.1 Tanhualin, Wuchang District, Wuhan, 430065, Hubei, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""The Third Department of Neurology, The Second Affiliated Hospital of Xi'an Medical University, NO.167, Textile City East Street, Baqiao District, Xi'an, 710032, Shanxi, China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Zhangjiang Hi-Tech Park, Pudong New Area, Shanghai, 201203, China. zhoushuang8008@163.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Emergency Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1095 Jie Fang Avenue, Hankou, Wuhan, 430030, Hubei, China. andyterry555@163.com.'}]",Trials,['10.1186/s13063-020-04498-6'] 2724,32580771,"Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine and prevalence of molecular markers associated with resistance, Guinea: an open-label two-arm randomised controlled trial.","BACKGROUND Anti-malarial resistance is a threat to recent gains in malaria control. This study aimed to assess the efficacy and safety of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) in the management of uncomplicated malaria and to measure the prevalence of molecular markers of resistance of Plasmodium falciparum in sentinel sites in Maferinyah and Labé Health Districts in Guinea in 2016. METHODS This was a two-arm randomised controlled trial of the efficacy of AL and ASAQ among children aged 6-59 months with uncomplicated Plasmodium falciparum malaria in two sites. Children were followed for 28 days to assess clinical and parasitological response. The primary outcome was the Kaplan-Meier estimate of Day 28 (D28) efficacy after correction by microsatellite-genotyping. Pre-treatment (D0) and day of failure samples were assayed for molecular markers of resistance in the pfk13 and pfmdr1 genes. RESULTS A total of 421 participants were included with 211 participants in the Maferinyah site and 210 in Labé. No early treatment failure was observed in any study arms. However, 22 (5.3%) participants developed a late treatment failure (8 in the ASAQ arm and 14 in the AL arm), which were further classified as 2 recrudescences and 20 reinfections. The Kaplan-Meier estimate of the corrected efficacy at D28 was 100% for both AL and ASAQ in Maferinyah site and 99% (95% Confidence Interval: 97.2-100%) for ASAQ and 99% (97.1-100%) for AL in Labé. The majority of successfully analysed D0 (98%, 380/389) and all day of failure (100%, 22/22) samples were wild type for pfk13. All 9 observed pfk13 mutations were polymorphisms not associated with artemisinin resistance. The NFD haplotype was the predominant haplotype in both D0 (197/362, 54%) and day of failure samples (11/18, 61%) successfully analysed for pfmdr1. CONCLUSION This study observed high efficacy and safety of both ASAQ and AL in Guinea, providing evidence for their continued use to treat uncomplicated malaria. Continued monitoring of ACT efficacy and safety and molecular makers of resistance in Guinea is important to detect emergence of parasite resistance and to inform evidence-based malaria treatment policies.",2020,This was a two-arm randomised controlled trial of the efficacy of AL and ASAQ among children aged 6-59 months with uncomplicated Plasmodium falciparum malaria in two sites.,"['421 participants were included with 211 participants in the Maferinyah site and 210 in Labé', 'sentinel sites in Maferinyah and Labé Health Districts in Guinea in 2016', 'children aged 6-59\xa0months with uncomplicated Plasmodium falciparum malaria in two sites']","['artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL', 'AL and ASAQ', 'artesunate-amodiaquine and artemether-lumefantrine']","['efficacy and safety', 'Kaplan-Meier estimate of Day 28 (D28) efficacy after correction by microsatellite-genotyping. Pre-treatment (D0) and day of failure samples', 'late treatment failure', 'Efficacy and safety']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018381', 'cui_str': 'Guinea Republic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0024535', 'cui_str': 'Falciparum malaria'}]","[{'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]",421.0,0.233206,This was a two-arm randomised controlled trial of the efficacy of AL and ASAQ among children aged 6-59 months with uncomplicated Plasmodium falciparum malaria in two sites.,"[{'ForeName': 'Abdoul Habib', 'Initials': 'AH', 'LastName': 'Beavogui', 'Affiliation': 'Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea. bea@maferinyah.org.'}, {'ForeName': 'Alioune', 'Initials': 'A', 'LastName': 'Camara', 'Affiliation': ""Centre d'Excellence Africain pour la Prévention et le Contrôle des Maladies Transmissibles (CEA-PCMT), Gamal Abdel Nasser University, Conakry, Guinea.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Delamou', 'Affiliation': 'Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.'}, {'ForeName': 'Mamadou Saliou', 'Initials': 'MS', 'LastName': 'Diallo', 'Affiliation': 'Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Doumbouya', 'Affiliation': 'Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.'}, {'ForeName': 'Karifa', 'Initials': 'K', 'LastName': 'Kourouma', 'Affiliation': 'Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Bouedouno', 'Affiliation': 'Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Guilavogui', 'Affiliation': 'Direction of Epidemiology, Ministry of Health, Conakry, Guinea.'}, {'ForeName': 'Samaly', 'Initials': 'S', 'LastName': 'Dos Santos Souza', 'Affiliation': 'Malaria Branch, Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kelley', 'Affiliation': 'Atlanta Research and Education Foundation and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Eldin', 'Initials': 'E', 'LastName': 'Talundzic', 'Affiliation': 'Malaria Branch, Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Aissata', 'Initials': 'A', 'LastName': 'Fofana', 'Affiliation': 'RTI International, Conakry, Guinea.'}, {'ForeName': 'Mateusz M', 'Initials': 'MM', 'LastName': 'Plucinski', 'Affiliation': ""Malaria Branch and U.S. President's Malaria Initiative, Centers for Disease Control and Prevention, Atlanta, USA.""}]",Malaria journal,['10.1186/s12936-020-03290-w'] 2725,32585077,"""Patients are not the same, so we cannot treat them the same"" - A qualitative content analysis of provider, patient and implementer perspectives on differentiated service delivery models for HIV treatment in South Africa.","INTRODUCTION In 2014, the South African government adopted a differentiated service delivery (DSD) model in its ""National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)"" (AGL) to strengthen the HIV care cascade. We describe the barriers and facilitators of the AGL implementation as experienced by various stakeholders in eight intervention and control sites across four districts. METHODS Embedded within a cluster-randomized evaluation of the AGL, we conducted 48 in-depth interviews (IDIs) with healthcare providers, 16 IDIs with Department of Health and implementing partners and 24 focus group discussions (FGDs) with three HIV patient groups: new, stable and those not stable on treatment or not adhering to care. IDIs were conducted from August 2016 to August 2017; FGDs were conducted in January to February 2017. Content analysis was guided by the Consolidated Framework for Implementation Research. Findings were triangulated among respondent types to elicit barriers and facilitators to implementation. RESULTS New HIV patients found counselling helpful but intervention respondents reported sub-optimal counselling and privacy concerns as barriers to initiation. Providers felt insufficiently trained for this intervention and were confused by the simultaneous rollout of the Universal Test and Treat strategy. For stable patients, repeat prescription collection strategies (RPCS) were generally well received. Patients and providers concurred that RPCS reduced congestion and waiting times at clinics. There was confusion though, among providers and implementers, around implementation of RPCS interventions. For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges. All providers faced difficulties accessing data and identifying patients in need of tracing. Congestion at clinics and staff attitude were perceived as barriers preventing patients returning to care. CONCLUSIONS Implementation of DSD models at scale is complex but this evaluation identified several positive aspects of AGL implementation. The positive perception of RPCS interventions and challenges managing patients not stable on treatment aligned with results from the larger evaluation. While some implementation challenges may resolve with experience, ensuring providers and implementers have the necessary training, tools and resources to operationalize AGL effectively is critical to the overall success of South Africa's HIV control strategy.",2020,"For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges.","['IDIs were conducted from August 2016 to August 2017; FGDs were conducted in January to February 2017', '48 in-depth interviews (IDIs) with healthcare providers, 16 IDIs with Department of Health and implementing partners and 24 focus group discussions (FGDs) with three HIV patient groups']","['AGL', 'new, stable and those not stable on treatment or not adhering to care']",['congestion and waiting times'],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0350601,"For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges.","[{'ForeName': 'Sophie J S', 'Initials': 'SJS', 'LastName': 'Pascoe', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Huber', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Aneesa', 'Initials': 'A', 'LastName': 'Moolla', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mokgadi', 'Initials': 'M', 'LastName': 'Phokojoe', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Marelize', 'Initials': 'M', 'LastName': 'Gorgens', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Yogan', 'Initials': 'Y', 'LastName': 'Pillay', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fraser-Hurt', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25544'] 2726,32585079,"Clinical evaluation of efficacy, safety and tolerability of cysteamine 5% cream in comparison with modified Kligman's formula in subjects with epidermal melasma: A randomized, double-blind clinical trial study.","BACKGROUND Kligman's formula (KF) remains to date the dermatologists' treatment of choice for melasma. This study was aimed at the evaluation of the effectiveness of Modified Kligman's formula (MKF) in comparison with cysteamine 5% cream on the severity of epidermal melasma. MATERIALS AND METHODS A total of 50 subjects with epidermal melasma were included in this double-blind, randomized trial study. Subjects received either cysteamine 5% cream or an MKF (4% hydroquinone, 0.05% retinoic acid and 0.1% betamethasone). Cysteamine cream (applied once daily, 15 minutes exposure) or MKF (applied once daily, whole night exposure) were used by the subjects over four consecutive months. The efficacy of the treatments was determined through the modified Melasma Area Severity Index (mMASI) score, the Investigator's Global Assessment (IGA) and patient questionnaires. RESULTS The mean (SD) age of the subjects was 34.96 (6.17) and 35.76 (5.23) years for cysteamine and MKF group, respectively. The mean mMASI score after 4 months was 7.04 (2.23) in the MKF group and 6.09 (2.01) in the cysteamine group. At both prospective evaluation points (2 months, 4 months), the percentage reduction in mMASI score was approximately 9% greater by cysteamine cream as compared to MKF, and these differences were statistically significant (P = .005 and .001 respectively). CONCLUSION Cysteamine 5% cream showed greater efficacy as compared to MKF. It is thus proposed that cysteamine 5% cream is more effective than MKF in the treatment of melasma, with the advantage of being significantly better tolerated.",2020,"At both prospective evaluation points (2 months, 4 months), the percentage reduction in mMASI score was approximately 9% greater by cysteamine cream as compared to MKF, and these differences were statistically significant (P = .005 and .001 respectively). ","['subjects with epidermal melasma', '50 subjects with epidermal melasma']","['MKF', 'cysteamine 5% cream or an MKF (4% hydroquinone, 0.05% retinoic acid and 0.1% betamethasone', 'cysteamine 5% cream', 'Cysteamine cream', ""Modified Kligman's formula (MKF""]","['mean mMASI score', 'severity of epidermal melasma', 'percentage reduction in mMASI score', ""modified Melasma Area Severity Index (mMASI) score, the Investigator's Global Assessment (IGA) and patient questionnaires"", 'efficacy, safety and tolerability']","[{'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.0694425,"At both prospective evaluation points (2 months, 4 months), the percentage reduction in mMASI score was approximately 9% greater by cysteamine cream as compared to MKF, and these differences were statistically significant (P = .005 and .001 respectively). ","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': 'Department of Dermatology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'David', 'Affiliation': 'Schweiger Dermatology Group, Philadelphia, PA, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI),['10.1111/srt.12901'] 2727,32585169,Effectiveness of high-intensity interval training versus moderate-intensity continuous training in patients with fibromyalgia: A pilot randomized controlled trial.,"OBJECTIVE To compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) combined with strengthening and stretching exercises in patients with fibromyalgia. DESIGN Interventional, single-blinded, randomized-controlled trial. SETTING Outpatient rehabilitation center. PARTICIPANTS Sixty women diagnosed with fibromyalgia were randomized to HIIT, MICT and Control groups. INTERVENTIONS HIIT included a 5-min warm-up at 50% of peak-HR, four cycles of 4-min at 80-95% of peak-HR followed by 3-min recovery intervals at 70% of peak-HR. MICT consisted of 45-min at 65-70% of peak-HR. Each aerobic training session was followed by standardized strengthening and stretching exercises. The programs performed using cycle-ergometers 5-sessions per-week for 6-weeks. The control group did not participate in any supervised exercise sessions. MAIN OUTCOME MEASURES The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). The secondary outcome measures were visual analogic scale for pain, Short Form Health Survey-36 (SF-36), cardiopulmonary exercise test (CPET) and body composition parameters. RESULTS Fifty-five participants completed the study. There was no significant difference in FIQ between HIIT vs MICT (1.03; 95% confidence interval (CI) -9.67 to 11.75) after treatment. Group-time interactions were significant for the FIQ between interventions and control (HIIT vs Control -16.20; 95% CI -27.23 to -5.13 and MICT vs Control -17.24; 95% CI -28.27 to -6.22) (all P<0.001). There were significant group-time interactions for the pain, SF-36 and CPET parameters between treatments and control (all P<0.05). Body-weight, fat-percentage, fat-mass and body mass index improved significantly (all P<0.05) only in MICT group after treatment. CONCLUSIONS The HIIT plus strengthening and stretching exercises and MICT plus strengthening and stretching exercises interventions showed significant improvements for the impact of fibromyalgia, pain degree, functional capacity and quality of life compared to the control group. HIIT was not superior to MICT. Furthermore, body composition parameters were improved significantly only for the MICT.",2020,"The HIIT plus strengthening and stretching exercises and MICT plus strengthening and stretching exercises interventions showed significant improvements for the impact of fibromyalgia, pain degree, functional capacity and quality of life compared to the control group.","['Fifty-five participants completed the study', 'patients with fibromyalgia', 'Outpatient rehabilitation center', 'Sixty women diagnosed with fibromyalgia']","['high-intensity interval training versus moderate-intensity continuous training', 'HIIT, MICT', 'MICT', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) combined with strengthening and stretching exercises', 'supervised exercise sessions', 'stretching exercises and MICT plus strengthening and stretching exercises interventions']","['Body-weight, fat-percentage, fat-mass and body mass index', 'fibromyalgia, pain degree, functional capacity and quality of life', 'visual analogic scale for pain, Short Form Health Survey-36 (SF-36), cardiopulmonary exercise test (CPET) and body composition parameters', 'body composition parameters', 'pain, SF-36 and CPET parameters', 'FIQ', 'Fibromyalgia Impact Questionnaire (FIQ']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.131849,"The HIIT plus strengthening and stretching exercises and MICT plus strengthening and stretching exercises interventions showed significant improvements for the impact of fibromyalgia, pain degree, functional capacity and quality of life compared to the control group.","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Atan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gaziler Physical Therapy and Rehabilitation Education and Research Hospital, Ankara, Turkey. Electronic address: tubaatan@gmail.com.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Karavelioğlu', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Hitit University, Corum, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.022'] 2728,32476183,Does the Sequence of Anthracycline and Taxane Matter? The NeoSAMBA Trial.,"BACKGROUND Taxanes usually follow anthracyclines in breast cancer neo/adjuvant treatment, likely because of their later introduction into clinical practice. However, there is no biological rationale that justifies this current standard of care. We compared a taxane followed by an anthracycline-based regimen with the reverse sequence in the neoadjuvant setting. PATIENTS AND METHODS In a randomized, open-label, single-center phase II trial, women with inoperable, locally advanced, HER2-negative breast cancer were stratified by hormone receptor status and randomized to three cycles of docetaxel (T) followed by three cycles of fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus three cycles of FAC followed by three cycles of docetaxel. Surgery, radiotherapy, and adjuvant hormonal therapy were administered as per local guidelines. The primary endpoint was pathological complete response (pCR), and secondary endpoints included toxicity, event-free survival (EFS), and overall survival (OS). RESULTS Treatment sequence did not improve pCR, which was 7% with T-FAC and 3% with FAC-T. However, after a median follow-up of 79 months, the 5-year EFS rate was 75.7% (95% confidence interval [CI], 65.4%-87.7%) with T-FAC and 48.2% (95% CI, 37.0%-62.7%) with FAC-T (hazard ratio [HR], 0.46; 95% CI, 0.26-0.81; log-rank p = .0054), and the 5-year OS rate was 89.7% (95% CI, 82.2%-97.8%) with T-FAC and 64.7% (95% CI, 53.6%-78.1%) with FAC-T (HR, 0.41; 95% CI, 0.22-0.78; p = .0052). There were no unexpected toxicities. CONCLUSION We showed for the first time an improvement in EFS and OS with taxane-first compared with anthracycline-first sequencing chemotherapy in HER2-negative, locally advanced breast cancer. Confirmation of these results may have implications for clinical practice. This trial was registered with Clinicatrials.gov identifier NCT01270373. IMPLICATIONS FOR PRACTICE The NeoSAMBA trial showed a benefit for taxane-first sequencing chemotherapy consistent with the systematic review of the literature as well as the larger Neo-tAnGo study. Many recent and current ongoing clinical trials have already followed this treatment strategy. As a taxane-before-anthracycline sequence carries neither an incremental cost nor an increased toxicity, and given the available literature on this issue, reinforced that taxane-first regimen can be easily incorporated into daily clinical practice while awaiting confirmation of these findings from larger trials.",2020,"RESULTS Treatment sequence did not improve pCR, which was 7% with T-FAC and 3% with FAC-T.","['women with inoperable, locally advanced, HER2-negative breast cancer', 'HER2-negative, locally advanced breast cancer']","['taxane-before-anthracycline sequence', 'docetaxel', 'docetaxel (T) followed by three cycles of fluorouracil, doxorubicin, and cyclophosphamide (FAC', 'taxane', 'taxane-first sequencing chemotherapy', 'anthracycline-first sequencing chemotherapy', 'Surgery, radiotherapy, and adjuvant hormonal therapy']","['pCR', 'pathological complete response (pCR), and secondary endpoints included toxicity, event-free survival (EFS), and overall survival (OS', 'toxicities', '5-year OS rate', '5-year EFS rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.165929,"RESULTS Treatment sequence did not improve pCR, which was 7% with T-FAC and 3% with FAC-T.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bines', 'Affiliation': 'Medical Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Isabele A', 'Initials': 'IA', 'LastName': 'Small', 'Affiliation': 'Clinical Research, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Sarmento', 'Affiliation': 'Clinical Research, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Kestelman', 'Affiliation': 'Radiology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Silvania', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Clinical Research, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fabiana Resende', 'Initials': 'FR', 'LastName': 'Rodrigues', 'Affiliation': 'Pathology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Faroni', 'Affiliation': 'Radiation Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Medical Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ebecken', 'Affiliation': 'Medical Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Maroun', 'Affiliation': 'Surgery, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Millen', 'Affiliation': 'Surgery, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bonamino', 'Affiliation': 'Immunology and Tumor Biology Program - Research Coordination, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}]",The oncologist,['10.1634/theoncologist.2019-0805'] 2729,32482626,Prioritisation of treatment goals among older patients with non-curable cancer: the OPTion randomised controlled trial in Dutch primary care.,"BACKGROUND Older patients with cancer often find it difficult to take part in shared decision making. AIM To assess the utility of the Outcome Prioritisation Tool (OPT), designed to aid discussion with a patient in regards to their treatment goals, to empower patients with cancer through structured conversations about generic treatment goals with GPs. DESIGN AND SETTING A randomised controlled trial of 114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist. The intervention group used the OPT while the control group received care as usual. METHOD The primary outcome was patient empowerment using the score on the decision self-efficacy (DSE) scale. Secondary outcomes were symptoms measures of fatigue, anxiety, and depression. The experiences of participants were also explored. RESULTS No effect was found on patient empowerment between the OPT group ( n = 48; DSE 86.8; standard deviation [SD] = 18.2) and the control group ( n = 58; DSE 84.2; SD = 17.6; P = 0.47). In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05). Overall, 44.8% ( n = 13) of patients indicated that the OPT-facilitated conversation helped them make a treatment decision, and 31.1% ( n = 14) of the GPs reported that they gained new insights from the conversation. CONCLUSION An OPT-facilitated conversation about generic treatment goals between patients and their GPs is associated with less anxiety and fatigue, but did not show statistically significant improvements in patient empowerment. Adding the OPT to routine care might ensure more patient-tailored care.",2020,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05).","['Older patients with cancer', 'older patients with non-curable cancer', 'patients with cancer through structured conversations about generic treatment goals with GPs', '114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist']","['OPT while the control group received care as usual', 'Outcome Prioritisation Tool (OPT']","['symptoms measures of fatigue, anxiety, and depression', 'patient empowerment using the score on the decision self-efficacy (DSE) scale', 'mild fatigue', 'anxiety and fatigue', 'patient empowerment', 'mean anxiety scores', 'low empowerment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",114.0,0.0458868,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05).","[{'ForeName': 'Mariken E', 'Initials': 'ME', 'LastName': 'Stegmann', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Brandenbarg', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'An Kl', 'Initials': 'AK', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Department of Pulmonary Diseases, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'T Jeroen N', 'Initials': 'TJN', 'LastName': 'Hiltermann', 'Affiliation': 'Department of Pulmonary Diseases and Tuberculosis, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'Berendsen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X710405'] 2730,32483678,Treatment of avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma: a prospective not controlled study.,"PURPOSE Core decompression is a surgical option since the 1960s for hip osteonecrosis treatment. This technique promotes bone repair by reducing intramedullary pressure, but this is not often enough to stop the progression of necrosis. The aim of this study was to associate core decompression with the regenerative stimulus provided by platelet-rich plasma (PRP) and compare our results with other regenerative techniques. METHODS Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60 years) treated by core decompression and PRP graft. Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification. The outcome was assessed by changes in Harris Hip Score (HHS) and the need for total hip replacement (THA). RESULTS The mean preoperative HHS was 64 points, at two years from surgery was roughly 84 points. Sixteen of 30 hips showed osteonecrosis progression of the femoral head and were converted to THA. At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively. CONCLUSION Core decompression combined with PRP could be indicated as a treatment for the I and IIA stages of osteonecrosis, as it significantly reduces joint pain and delays THA. This procedure should be avoided in AVNFH related to cortisone therapy because only a few benefits have been proven. It also has the advantage of being technically simple, minimally invasive, and free from complications.",2020,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively. ","['avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma', 'Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60\xa0years) treated by core decompression and PRP graft', 'Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification']",['PRP'],"['Harris Hip Score (HHS) and the need for total hip replacement (THA', 'osteonecrosis progression', 'mean preoperative HHS', 'joint pain and delays THA', 'survival rate']","[{'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0353426,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively. ","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy. marco.grassi7@gmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Salari', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Massetti', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Giuseppe F', 'Initials': 'GF', 'LastName': 'Papalia', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gigante', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}]",International orthopaedics,['10.1007/s00264-020-04628-4'] 2731,32483847,Efficacy of prucalopride in critically ill patients with paralytic ileus: A pilot randomized double-blind placebo-controlled trial.,"BACKGROUND AND AIM Paralytic ileus is a common intestinal dysfunction in critically ill patients, which results in complications and poor hospital outcomes. There are still no established effective medications, except correcting the primary causes and prokinetics trial, which have limited efficacy and potential adverse events. This study aims to evaluate the efficacy of prucalopride on paralytic ileus in critically ill patients. METHODS A randomized, double-blind, placebo-controlled trial of five consecutive days treatment periods was conducted. Critically ill patients with paralytic ileus were included. The primary endpoint was the improvement of bowel dilatation on plain abdominal radiography. The secondary endpoint was the change of abdominal circumference. RESULTS Twenty patients were consecutively enrolled in the study. There was no significant difference in baseline characteristics of patients. The common causes of hospitalization were infection and respiratory problems. The maximum large bowel diameters dramatically decreased in prucalopride group and reached maximum point on the third day after intervention when compared with placebo (-2.1 [± 1.8] vs 0.3 [± 1.5] cm, P = 0.01). The maximum small bowel diameters were noticeably less decreased and were not significantly different when compared with placebo. The abdominal circumferences notably decreased and significantly diverged from placebo on the third day. CONCLUSIONS Prucalopride was an effective enterokinetic agent to improve non-severe inflammatory/ischemic bowel conditions related paralytic ileus in critically ill patients. Its effect was predominant on large intestine but could not be well demonstrated on small bowel in this study. Future study or concomitant other prokinetics for upper gut motility should be further evaluated.",2020,"CONCLUSIONS Prucalopride was an effective enterokinetic agent to improve non-severe inflammatory or ischemic bowel conditions related paralytic ileus in critically ill patients.","['Twenty patients were consecutively enrolled in the study', 'critically ill patients', 'Critically ill patients with paralytic ileus', 'critically ill patients with paralytic ileus']","['prucalopride', 'placebo']","['maximum large bowel diameters', 'paralytic ileus', 'improvement of bowel dilatation on plain abdominal radiography', 'abdominal circumferences', 'maximum small bowel diameters', 'change of abdominal circumference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030446', 'cui_str': 'Paralytic ileus'}]","[{'cui': 'C0913506', 'cui_str': 'prucalopride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021851', 'cui_str': 'Structure of large intestine'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0030446', 'cui_str': 'Paralytic ileus'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0034573', 'cui_str': 'Diagnostic radiography of abdomen'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.682667,"CONCLUSIONS Prucalopride was an effective enterokinetic agent to improve non-severe inflammatory or ischemic bowel conditions related paralytic ileus in critically ill patients.","[{'ForeName': 'Sawangpong', 'Initials': 'S', 'LastName': 'Jandee', 'Affiliation': 'Gastroenterology and Hepatology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Wetwittayakhlang', 'Affiliation': 'Gastroenterology and Hepatology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Pattira', 'Initials': 'P', 'LastName': 'Boonsri', 'Affiliation': 'Diagnostic Radiology Unit, Division of Radiology, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15127'] 2732,32479794,"Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial.","BACKGROUND We evaluated the efficacy and safety of tepotinib, a potent and highly selective oral MET inhibitor, plus gefitinib in patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition. METHODS In this open-label, phase 1b/2, multicentre, randomised trial (the INSIGHT study), we enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries. In phase 1b, patients received oral tepotinib 300 mg or 500 mg plus gefitinib 250 mg once daily. In phase 2, patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification were randomly assigned (initially in a 1:1 ratio and then 2:1 following a protocol amendment) to tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy. Randomisation was done centrally via an interactive voice-response system. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. Subgroup analyses were preplanned in patients with high MET overexpression (IHC3+) or MET amplification (mean gene copy number ≥5 or MET to centromere of chromosome 7 ratio ≥2). Efficacy and patient characteristics were assessed on an intention-to-treat basis and safety was assessed for all patients who received at least one dose of study medication. Low recruitment led to early termination of phase 2, so all analyses are considered to be exploratory. This study is registered with ClinicalTrials.gov, NCT01982955, and the European Union Drug Regulating Authorities Clinical Trials Database, Eudra-CT 2016-001604-28. FINDINGS From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group; n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group; n=24 in the chemotherapy group). No dose-limiting toxicities were observed in phase 1b, so tepotinib 500 mg was used as the recommended phase 2 dose. In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio [HR] 0·67, 90% CI 0·35-1·28). Median OS was 17·3 months in the tepotinib plus gefitinib group (12·1-37·3) versus 18·7 months in the chemotherapy group (15·9-20·7; HR 0·69, 0·34-1·41). PFS and OS were longer with tepotinib plus gefitinib than with chemotherapy in patients with high (IHC3+) MET overexpression (n=34; median PFS 8·3 months [4·1-16·6] vs 4·4 months [4·1-6·8]; HR 0·35, 0·17-0·74; median OS 37·3 months [90% CI 24·2-37·3] vs 17·9 months [12·0-20·7]; HR 0·33, 0·14-0·76) or MET amplification (n=19; median PFS 16·6 months [8·3-not estimable] vs 4·2 months [1·4-7·0]; HR 0·13, 0·04-0·43; median OS 37·3 months [90% CI not estimable] vs 13·1 months [3·25-not estimable]; HR 0·08, 0·01-0·51). The most frequent treatment-related grade 3 or worse adverse events were increased amylase (5 [16%] of 31 patients) and lipase (4 [13%]) concentrations in the tepotinib plus gefitinib group and anaemia (7 [30%] of 23 patients) and decreased neutrophil count (3 [13%]) in the chemotherapy group. INTERPRETATION Despite early study termination, in a preplanned subgroup analysis, our findings suggest improved anti activity for tepotinib plus gefitinib compared with standard chemotherapy in patients with EGFR-mutant NSCLC and MET amplification, warranting further exploration. FUNDING Merck KGaA.",2020,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","['From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group', 'patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition', 'patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study', 'n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group', 'patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification', 'n=24 in the chemotherapy group', 'enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries']","['Tepotinib plus gefitinib', 'standard chemotherapy', 'oral tepotinib 300 mg or 500 mg plus gefitinib', 'tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy']","['investigator-assessed progression-free survival (PFS', 'anti activity', 'Median OS', 'neutrophil count', 'median PFS', 'anaemia', 'intention-to-treat basis and safety', 'adverse events', 'PFS and OS', 'No dose-limiting toxicities', 'overall survival (OS) and safety', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",18.0,0.166598,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Chest Hospital, Shanghai, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ross Andrew', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'National University Cancer Institute, Singapore.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Zhejiang Medical University, Zhejiang, China.'}, {'ForeName': 'Yuh-Min', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Chest Medicine, Taipei Veteran General Hospital and School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chih-Feng', 'Initials': 'CF', 'LastName': 'Chian', 'Affiliation': 'Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Daniel Shao Weng', 'Initials': 'DSW', 'LastName': 'Tan', 'Affiliation': 'National Cancer Center, Singapore.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bruns', 'Affiliation': 'Biostatistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Straub', 'Affiliation': 'Translational Medicine, Department of Clinical Biomarkers and Companion Diagnostics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Johne', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scheele', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30154-5'] 2733,32481441,The 95% effective dose of nalbuphine in patient-controlled intravenous analgesia for patients undergoing laparoscopic total hysterectomy compared to equivalent sufentanil.,"PURPOSE To evaluate the 95% effective dose of nalbuphine in patient-controlled intravenous analgesia (PCIA) by the sequential method and compare the analgesia efficacy with the equivalent dose of sufentanil on patients undergoing laparoscopic total hysterectomy. METHODS In the first part, we defined a successful analgesia as the highest VAS ≤3 in 24 hours postoperatively. On the contrary, a failed analgesia was the highest VAS>3. According to the last patient's outcome, the next patients would be given an increase or decreased dose grade. This process ended up with 9 cross-over points. In the second part, 60 patients undergoing laparoscopic total hysterectomy were selected. They were randomly divided into 2 groups (n = 30 each group): receiving sufentanil 1.78 μg/kg (group S) and nalbuphine 1.78 mg/kg (group N). PCIA pump was given at the end of the operation with 5 mL bonus loading. The total amount of PCIA was 100 mL and programmed to deliver 0.5 mL each time with a lockout interval of 15 minutes and the background infusion amount of 2 mL/h. The VAS score and Ramsay score of were collected after the operation, the number of effective pressing times of PCIA were also recorded. Adverse reactions were documented in detail. RESULTS The 95% effective dose of nalbuphine in PCIA on patients undergoing laparoscopic total hysterectomy was 1.78 mg/kg. There was no significant difference in VAS between the sufentanil group and the nalbuphine groups (P > .05), but the number of the use of PCIA in the group S was more than that in the group N obviously (P <.05). The group S has a lower ramsay sedation score than group N at every time point. (P <.05). The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P >  q .05). CONCLUSION Nalbuphine 1.78 mg/kg in PCIA is recommended for the patients undergoing laparoscopic total hysterectomy. And nalbuphine is a reasonable alternative to sufentanil when used in PCIA.",2020,"The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P >  q .05). ","['60 patients undergoing laparoscopic total hysterectomy were selected', 'patients undergoing laparoscopic total hysterectomy', 'patient-controlled intravenous analgesia (PCIA']","['nalbuphine', 'PCIA pump', 'sufentanil 1.78\u200aμg/kg (group S) and nalbuphine 1.78\u200amg/kg', 'sufentanil', 'Nalbuphine 1.78\u200amg/kg in PCIA']","['VAS score and Ramsay score', 'ramsay sedation score', 'number of the use of PCIA', 'VAS', 'nausea and vomiting', 'analgesia efficacy', 'number of effective pressing times of PCIA', 'Adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404090', 'cui_str': 'Laparoscopic total hysterectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",60.0,0.0470313,"The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P >  q .05). ","[{'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020424'] 2734,32481442,Effects of mild hypothermia on serum HMGB1 of brain-dead donors and its impact on kidney transplantation recipients.,"Investigate the effect of mild hypothermia on serum inflammatory factor HMGB1 of brain-dead donors, and its significance for renal transplantation recipients.In our hospital between January 2018 and January 2019 up to the standard of brain death donor (aged 18 to 65 years old) prospective cohort study, brain death donor were randomly divided into mild hypothermia group and the non-mild hypothermia group. Serum were collected from donor at different periods, and enzyme-linked immunoassay (ELISA) was used to determine the serum HMGB1 concentration to compare the difference between the 2 donor groups. The early recovery of renal function after renal transplantation was followed up, and the incidence of delayed graft function (DGF) and early recovery of renal function were compared between the 2 groups. The correlation between donor HMGB1 and recipient DGF was analyzed.Between 17 donors in the mild hypothermia group and 17 in the non-mild hypothermia group, there were no statistically significant differences in the age, perioperative urine volume and ICU stay between the 2 groups. After mild hypothermia treatment, serum HMGB1 levels of brain death donors were significantly decreased. While in non-mild hypothermia brain death donor group without treatment, serum HMGB1 was significantly increased. There were no statistically significant differences in age and preoperative creatinine between the 2 recipient groups, including 33 patients in the mild hypothermia group and 34 patients in the non-mild hypothermia group. DGF incidence was lower in mild hypothermia group comparing with non-mild hypothermia group with statistical significance. The levels of HMGB1 from donor before procurement is correlated with the occurrence of DGF of the recipient.Mild hypothermia therapy can reduce the levels of serum HMGB1, improve the function of donor organs. The levels of HMGB1 before donor procurement can be used to predict the occurrence of DGF in kidney transplant recipients. Our study shows that HMGB1 can be potentially used as therapeutic target of early intervention for brain death donors. Furthermore, mild hypothermia therapy can be applied in the maintenance of brain death donors for kidney transplant recipient to improve the successful rate of transplantation.",2020,The levels of HMGB1 before donor procurement can be used to predict the occurrence of DGF in kidney transplant recipients.,"['renal transplantation recipients', 'In our hospital between January 2018 and January 2019 up to the standard of brain death donor (aged 18 to 65 years old) prospective cohort study, brain death donor', 'kidney transplant recipients', 'kidney transplantation recipients']","['Mild hypothermia therapy', 'mild hypothermia group and the non-mild hypothermia group', 'HMGB1', 'mild hypothermia']","['delayed graft function (DGF) and early recovery of renal function', 'renal function', 'serum HMGB1', 'levels of serum HMGB1', 'DGF incidence', 'age and preoperative creatinine', 'serum HMGB1 levels of brain death donors', 'age, perioperative urine volume and ICU stay', 'HMGB1 concentration']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0445043', 'cui_str': 'Mild hypothermia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0150513,The levels of HMGB1 before donor procurement can be used to predict the occurrence of DGF in kidney transplant recipients.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Zhe-Min', 'Initials': 'ZM', 'LastName': 'Lin', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Xue-Zhu', 'Initials': 'XZ', 'LastName': 'Wang', 'Affiliation': 'Office of Organ Donation and Transplantation Management.'}, {'ForeName': 'Zi-Xin', 'Initials': 'ZX', 'LastName': 'Mi', 'Affiliation': 'Office of Organ Donation and Transplantation Management.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Office of Organ Donation and Transplantation Management.'}, {'ForeName': 'Zi-Ren', 'Initials': 'ZR', 'LastName': 'Tang', 'Affiliation': 'Department of Emergency, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology.'}]",Medicine,['10.1097/MD.0000000000020425'] 2735,32481469,Total bile acid to platelet ratio: A noninvasive index for predicting liver fibrosis in primary biliary cholangitis.,"The aim of the study was to develop a new early noninvasive diagnostic model for primary biliary cholangitis (PBC).A total of 118 PBC patients who had undergone a liver biopsy were enrolled in the study, and were randomized into a model group (78 patients) and a validation group (40 patients). The patients' histological stages were based on the classifications of the Scheuer's stage. All common parameters and liver pathological results were analyzed. And total bile acid to platelet ratio, aspartate aminotransferase to platelet ratio index, fibrosis index based on 4 factors and red cell distribution width to platelet ratio were calculated.There were 106 (89.8%) women and 12 men in this study, and the number of patients in Scheuer stage I, II, III, and IV hepatic fibrosis was 52 (44.1%), 36 (30.5%), 26 (22.0%), and 4 (3.4%), respectively. The areas under the receiver operating characteristic curves of the total bile acid to platelet ratio (TPR), the aspartate aminotransferase to platelet ratio index, the fibrosis index based on 4 factors , and the red cell distribution width to platelet ratio for predicting advanced liver fibrosis were 0.771, 0.715, 0.618, and 0.517 respectively. The areas under the receiver operating characteristic curves of the TPR was higher than other non-invasive serological models.As a simple, inexpensive and easily accessible non-invasive liver fibrosis diagnostic model, the TPR may be a new noninvasive marker for predicting histologic severity of PBC.",2020,The areas under the receiver operating characteristic curves of the TPR was higher than other non-invasive serological models.,"['primary biliary cholangitis', 'primary biliary cholangitis ', '118 PBC patients who had undergone a liver biopsy']",['PBC).A'],"['Total bile acid to platelet ratio', 'IV hepatic fibrosis', 'total bile acid to platelet ratio (TPR), the aspartate aminotransferase to platelet ratio index, the fibrosis index based on 4 factors , and the red cell distribution width to platelet ratio for predicting advanced liver fibrosis', 'And total bile acid to platelet ratio, aspartate aminotransferase to platelet ratio index, fibrosis index based on 4 factors and red cell distribution width to platelet ratio']","[{'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0201914', 'cui_str': 'Total bile acids measurement'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]",118.0,0.0184379,The areas under the receiver operating characteristic curves of the TPR was higher than other non-invasive serological models.,"[{'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatology, the First Hospital of Jilin University, Changchun, Jilin Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Youyou', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Luyuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Pujun', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020502'] 2736,32481473,Effects of compound Caoshi silkworm granules on stable COPD patients and their relationship with gut microbiota: A randomized controlled trial.,"BACKGROUND AND PURPOSE Patients with chronic obstructive pulmonary disease (COPD) usually experience recurrent acute exacerbations. These patients, especially those with stable COPD, require an effective intervention for treating exacerbations. This study aimed to evaluate the efficacy of Compound Caoshi silkworm granules (CCSGs) in stable COPD patients and to investigate their potential mechanism. METHODS A randomized controlled trial was performed at Jinhua Hospital, Zhejiang University. Patients were enrolled in this study if they met the criterion of stable COPD. A total of 40 patients were randomly divided into the following 2 groups: Group A (n = 20, routine treatment (RT) group) and Group B (n = 20, RT plus CCSGs [RT plus CCSGs] group). The duration of treatment was 3 months. Stool samples were collected from all patients on day 0 and the gut microbiota was analyzed using 16s rRNA sequencing. The St. George's Respiratory Questionnaire (SGRQ) scores and lung function were assessed at month 0 and month 3. RESULTS The components of gut microbiota differed between stable COPD patients and the healthy population. The RT plus CCSGs group showed improved SGRQ scores compared to the RT group. There was no difference in forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity between the two groups. Furthermore, the abundance of gut microbiota in patients with the top 10 SGRQ scores (Group N) differed from the abundance of gut microbiota in those with the lowest 10 SGRQ scores (Group T). CONCLUSION CCSGs have beneficial effects in the improvement of symptoms in stable COPD patients over a 3-month treatment period. The potential underlying mechanism may be attributable to the difference in gut microbiota among patients. However, more research is needed to confirm this conclusion.",2020,"There was no difference in forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity between the two groups.","['stable COPD patients and the healthy population', 'stable COPD patients', '40 patients', 'Patients with chronic obstructive pulmonary disease (COPD) usually experience recurrent acute exacerbations', 'stable COPD patients and their relationship with gut microbiota', 'Jinhua Hospital, Zhejiang University']","['RT plus CCSGs [RT plus CCSGs', 'compound Caoshi silkworm granules', 'Compound Caoshi silkworm granules (CCSGs']","['abundance of gut microbiota', 'forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity', 'SGRQ scores', 'scores and lung function', ""St. George's Respiratory Questionnaire (SGRQ""]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0037119', 'cui_str': 'Bombyx'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0324333,"There was no difference in forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity between the two groups.","[{'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua, Zhejiang.'}, {'ForeName': 'Qinghuan', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Medicine. Zhejiang Chinese Medical University.'}, {'ForeName': 'Songmin', 'Initials': 'S', 'LastName': 'Ying', 'Affiliation': 'Department of Pharmacology and Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital, Institute of Respiratory Diseases, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Xiguang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Jilin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Feila', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Feibao', 'Initials': 'F', 'LastName': 'Tao', 'Affiliation': 'Department of Traditional Chinese Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua, Zhejiang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Traditional Chinese Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua, Zhejiang, China.'}]",Medicine,['10.1097/MD.0000000000020511'] 2737,32486934,Rituximab use as induction therapy for lupus nephritis: a systematic review.,"OBJECTIVE Rituximab (RTX) has important usage in rheumatoid arthritis and vasculitis. There remains a need for more, better, and safer treatments for patients with lupus nephritis (LN). RTX has been trialed in such patients without definitive conclusions about its effectiveness. As a role for RTX has not been clearly established for LN, we carried out a systematic review and analysis. METHODS We identified 31 studies of RTX for class I-VI LN, and assessed complete renal response (CRR) and partial renal response (PRR) using criteria including serum creatinine, proteinuria, and urinary sediment. Due to differences in the pediatric presentation of the disease, studies focusing on pediatric patients were excluded. RESULTS One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR). Six prospective and retrospective studies utilizing RTX monotherapy found 66% CRR or PRR in all patients. Eleven studies that investigated RTX in combination with CYC or mycophenolate mofetil (MMF) also found 66% CRR or PRR in all patients. In total, the CRR for Caucasian, East Asian, and Hispanic patients were 77%, 38%, and 28%, respectively. CONCLUSIONS RTX appeared to benefit certain LN patients, but most studies were not randomized or properly controlled, were heterogeneous in design, subjects, and LN types, and were not comparable, and must therefore be interpreted cautiously. RTX alone may not deplete B cells sufficiently for the perturbations of LN. In addition, RTX may induce responses differently among patients of different ethnic and racial backgrounds. Furthermore, there were wide variations in the baseline characteristics of the patients, namely LN class, time course of disease, age, and prior immunosuppressive use. We suggest a prospective RCT in patients aged 18-65 years with class IV LN. Ideally, the patients would not have received prior immunosuppression and would better represent different ethnicities. The treatment groups would be RTX, RTX+belimumab, CYC, and MMF groups, with pulse-dose steroids during induction followed by maintenance steroids and MMF. The CRR and PRR would be assessed at 12 and 24 months. This or a similar study might clarify RTX's role in the treatment of LN.",2020,One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR).,"['patients with lupus nephritis (LN', 'lupus nephritis', 'patients aged 18-65 years with class IV LN']","['Rituximab (RTX', 'Rituximab', 'mycophenolate mofetil (MMF', 'RTX', 'RTX, RTX+belimumab, CYC, and MMF groups, with pulse-dose steroids', 'RTX monotherapy', 'RTX+cyclophosphamide (CYC) versus CYC']","['complete renal response (CRR) and partial renal response (PRR) using criteria including serum creatinine, proteinuria, and urinary sediment', 'CRR and PRR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1261248', 'cui_str': 'Urine sediment'}]",,0.0609728,One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR).,"[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Stolyar', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lahita', 'Affiliation': ""Department of Medicine, St. Joseph's Regional Medical Centre, Paterson, USA.""}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Panush', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}]",Lupus,['10.1177/0961203320928412'] 2738,32488754,Effects of isoflavones on bone turnover markers in peritoneal dialysis patients: a randomized controlled trial.,"PURPOSE The aim of this study was to investigate the effects of soy isoflavones on serum markers of bone formation and resorption in peritoneal dialysis (PD) patients. METHODS In this randomized, double-blind, placebo-controlled trial, 40 PD patients were randomly assigned to either the soy isoflavone or the placebo group. The patients in the soy isoflavone group received 100 mg soy isoflavones daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of the 8th week, 7 ml of blood was obtained from each patient after a 12- to 14-h fast and serum concentrations of bone formation markers (osteocalcin and bone alkaline phosphatase), bone resorption markers [N-telopeptide and receptor activator of nuclear factor kappa B ligand (RANKL)], and osteoprotegerin as an inhibitor of bone resorption were measured. RESULTS Serum N-telopeptide concentration decreased significantly up to 27% in the soy isoflavone group at the end of week 8 compared to baseline (P = 0.003). Also, serum RANKL concentration reduced significantly up to 17% in the soy isoflavone group at the end of week 8 compared to baseline (P = 0.03). These bone resorption markers did not significantly change in the placebo group during the study. There were no significant differences between the two groups in mean changes of serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin. CONCLUSION This study indicates that daily administration of 100 mg soy isoflavone supplement to PD patients reduces serum N-telopeptide and RANKL which are two bone resorption markers. CLINICALTRIALS.GOV: NCT03773029, 2018.",2020,"There were no significant differences between the two groups in mean changes of serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin. ","['peritoneal dialysis (PD) patients', 'peritoneal dialysis patients', '40 PD patients']","['isoflavones', 'placebos', '100\xa0mg soy isoflavone supplement', 'soy isoflavone', '100\xa0mg soy isoflavones', 'soy isoflavones', 'placebo']","['serum N-telopeptide', 'Serum N-telopeptide concentration', 'serum markers of bone formation and resorption', 'serum concentrations of bone formation markers (osteocalcin and bone alkaline phosphatase), bone resorption markers [N-telopeptide and receptor activator of nuclear factor kappa B ligand (RANKL)], and osteoprotegerin as an inhibitor of bone resorption', 'bone turnover markers', 'bone resorption markers', 'serum RANKL concentration', 'serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C1868869', 'cui_str': 'N-telopeptide serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0666361', 'cui_str': 'TNFSF11 protein, human'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",40.0,0.271872,"There were no significant differences between the two groups in mean changes of serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin. ","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tabibi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, 46, West Arghavan St., Farahzadi Blvd., Shahrak Qods, P. O. Box 19395-4741, Tehran, Islamic Republic of Iran. hadtabibi@yahoo.com.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Najafi', 'Affiliation': 'Department of Nephrology, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.'}]",International urology and nephrology,['10.1007/s11255-020-02523-w'] 2739,31810730,A personalized behavioral intervention implementing mHealth technologies for older adults: A pilot feasibility study.,"Sedentary behavior has been associated with adverse health outcomes such as disturbed sleep in older adults. We conducted a single-group pretest and posttest study to evaluate the feasibility of a personalized behavioral intervention program using mobile health technology in improving physical activity and sleep in older adults. The four-week intervention included: personalized physical activity training, real-time physical activity self-monitoring, interactive prompts and feedback with a smartwatch, phone consultation with an exercise trainer and research team members, and weekly financial incentives for achieving weekly physical activity goals. Eight cognitively intact older adults were recruited and completed the study. Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention. Future studies will include a fully powered trial to evaluate the efficacy of this intervention in sedentary older adults.",2020,Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention.,"['Eight cognitively intact older adults', 'sedentary older adults', 'older adults']","['personalized behavioral intervention implementing mHealth technologies', 'personalized behavioral intervention program using mobile health technology', 'personalized physical activity training, real-time physical activity self-monitoring, interactive prompts and feedback with a smartwatch, phone consultation with an exercise trainer and research team members, and weekly financial incentives for achieving weekly physical activity goals']","['levels of physical activity', 'physical activity and sleep']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0171957,Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention.,"[{'ForeName': 'Junxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Johns Hopkins School of Nursing, 525 North Wolfe Street, Baltimore, MD 21205, United States. Electronic address: jli248@jhu.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hodgson', 'Affiliation': 'University of Pennsylvania School of Nursing, United States.'}, {'ForeName': 'M Melanie', 'Initials': 'MM', 'LastName': 'Lyons', 'Affiliation': 'University of Pennsylvania School of Nursing, United States; The Ohio State University College of Medicine, United States.'}, {'ForeName': 'Ker-Cheng', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'University of Pennsylvania School of Medicine, United States.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'University of Minnesota School of Nursing, United States.'}, {'ForeName': 'Nalaka S', 'Initials': 'NS', 'LastName': 'Gooneratne', 'Affiliation': 'University of Pennsylvania School of Medicine, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.11.011'] 2740,32485323,Moderators of treatment effects in a child maltreatment prevention programme in South Africa.,"BACKGROUND Previous research has found mixed results on whether the most disadvantaged families benefit as much as less disadvantaged families from parenting interventions designed to reduce child maltreatment, and little in known in low-income settings. OBJECTIVE In this study, we test the effects of child, caregiver, household, and community characteristics as treatment moderators of intervention outcomes - child maltreatment and parenting practices. We test characteristics previously examined elsewhere as well as factors relevant to the South African context. PARTICIPANTS AND SETTING This analysis includes adolescents (ages 10-18) and their caregivers (N = 552 pairs) who participated in a randomised trial of a parenting programme in the Eastern Cape Province of South Africa. METHODS Data from the caregiver and adolescent standardised questionnaires collected at baseline, post-test (1-month post-intervention), and follow-up (5-9 months) were analysed using longitudinal multilevel analyses. We tested seven hypothesised moderators for each of the primary outcomes through interactions of treatment effect with baseline moderators. RESULTS No moderator effects were statistically significant after correcting for multiple comparisons testing. Hence, in line with several recent studies examining moderation effects in parenting programmes, our study suggests that parenting interventions aiming to reduce child maltreatment and promote parenting skills in low- and middle-income countries may be similarly effective for families facing various levels of economic, social, and health risk factors. CONCLUSIONS It may be useful to explicitly power trials for testing moderator effects, study different types of moderators and use person-centred analyses to further understand variations in treatment effects.",2020,No moderator effects were statistically significant after correcting for multiple comparisons testing.,"['This analysis includes adolescents (ages 10-18) and their caregivers (N = 552 pairs) who participated in a randomised trial of a parenting programme in the Eastern Cape Province of South Africa', 'Data from the caregiver and adolescent standardised questionnaires collected at baseline, post-test (1-month post-intervention), and follow-up (5-9 months) were analysed using longitudinal multilevel analyses', 'child maltreatment prevention programme in South Africa']",[],[],"[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454728', 'cui_str': 'Cape Province'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0814909', 'cui_str': 'Multilevel Analysis'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],[],552.0,0.117227,No moderator effects were statistically significant after correcting for multiple comparisons testing.,"[{'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Department of Social Policy and Intervention, Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, OX1 2ER, Oxford, United Kingdom; Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Department of Social Policy and Intervention, Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, OX1 2ER, Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, J-Block, Groote Schuur Hospital, Observatory, 7925, Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Eisner', 'Affiliation': 'Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom; Jacobs Center for Productive Youth Development, University of Zurich, Andreasstrasse 15, 8050, Zürich, Switzerland. Electronic address: mpe23@cam.ac.uk.'}, {'ForeName': 'Aja Louise', 'Initials': 'AL', 'LastName': 'Murray', 'Affiliation': 'Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom; Department of Psychology, University of Edinburgh, Room F16, Psychology Building, 7 George Square, Edinburgh, EH8 9JZ, United Kingdom. Electronic address: Aja.Murray@ed.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104519'] 2741,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking. RESEARCH QUESTION Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters. METHODS This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments. RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain. SIGNIFICANCE This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030'] 2742,32585700,Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2.,"STUDY OBJECTIVES To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder. METHODS This was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study. RESULTS Decreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of Month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths. CONCLUSIONS LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.",2020,"CONCLUSIONS LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.","['949 participants with insomnia (age ≥18 years', 'adults with insomnia disorder', 'individuals with insomnia disorder versus']","['placebo or LEM (5 mg [LEM5] or 10 mg [LEM10', 'LEM', 'LEM5 and LEM10', 'lemborexant (LEM', 'lemborexant', 'placebo']","['quality of sleep', 'percentage of sleep onset responders and sleep maintenance responders', 'subjective sleep efficiency', 'sleep onset and sleep maintenance', 'tolerated', 'Sleep onset and sleep maintenance endpoints', 'low rate of serious TEAEs and no deaths']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",949.0,0.47688,"CONCLUSIONS LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.","[{'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kärppä', 'Affiliation': 'Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Yardley', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pinner', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kubota', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}]",Sleep,['10.1093/sleep/zsaa123'] 2743,32585738,Non-specific analgesia during a clinical trial in fibromyalgia.,"BACKGROUND When patients suffering from fibromyalgia undergo a therapeutic trial, a non-negligible part of analgesia is not explained by the drug itself. The mechanisms of this non-specific effect need to be understood. MATERIALS AND METHODS We undertook secondary analyses of a double-blind randomised trial in fibromyalgia patients in which 100mg/day milnacipran was not found superior to placebo. Data from 49 patients belonging to both groups were pooled. Both before treatment, and one month after treatment, all patients underwent a CaNTAB ® neuropsychological test (related to spatial planning, reaction time, decision-making and risk-taking, and ability to name objects), and measurements of sensation and pain thresholds to heat and cold, supraliminal heat pain threshold, punctuate mechanical pain threshold and temporal summation, mechanical allodynia to skin brushing, and response to conditioned pain modulation. We studied the baseline predictors of analgesia, and the indicators of change associated to analgesia separately. A stepwise approach was used to select the factors to enter into the final ANCOVAs, in which age, body mass index, treatment group and pain at baseline were covariates. RESULTS No baseline predictor of non-specific analgesia other than pain at baseline was found to be predictive. Conversely, several neuropsychological (higher performance) or psychophysical (lower sensitivity) changes correlated with analgesia in unadjusted analyses. Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia. CONCLUSIONS The changes observed concomitantly to non-specific pain analgesia might be related to mild changes in brain functioning, based on convergent literature data.",2020,"Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia. ","['49 patients belonging to both groups were pooled', 'patients suffering from fibromyalgia undergo a therapeutic trial', 'fibromyalgia patients in which 100mg/day']","['milnacipran', 'placebo']","['spatial planning, reaction time, decision-making and risk-taking, and ability to name objects), and measurements of sensation and pain thresholds to heat and cold, supraliminal heat pain threshold, punctuate mechanical pain threshold and temporal summation, mechanical allodynia to skin brushing, and response to conditioned pain modulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1533126', 'cui_str': 'milnacipran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C2936719', 'cui_str': 'Allodynia, Mechanical'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",49.0,0.116055,"Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia. ","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Macian', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Giron', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, F-63000, Clermont-Ferrand, France.'}]",European journal of clinical investigation,['10.1111/eci.13337'] 2744,32585741,Self-contrast Study of Pinprick Therapy Combined with Super Pulse Fractional CO 2 Laser for the Treatment of Atrophic Acne Scars.,"AIMS This study is to evaluate the clinical efficacy and safety of a ""double-layer"" mode of super pulse fractional CO 2 laser and a combined treatment of pinprick therapy with fractional CO 2 laser for the treatment of atrophic acne scars. METHODS A split-face and self-contrast method was applied. A total of 20 patients with atrophic acne scars randomly received the above mentioned therapy on the left or right side of the cheek for 3 times with an interval of 3 months. ECCA scores, IVA scores, patients' satisfaction, VAS scores, and adverse reactions were evaluated. RESULTS Atrophic acne scars on both sides of the cheek were improved obviously. The ECCA scores showed a significant decrease, while IVA scores significantly increased. Compared with the super pulse fractional CO 2 laser group, the decrease of ECCA scores, the increase of IVA scores and the patients' satisfaction were significantly higher and improvement on V-shaped and U-shaped acne scars was significantly better in the combined treatment group. No patients had severe adverse reactions such as blister, infection or hypertrophic scars. CONCLUSIONS Super pulse fractional CO 2 laser and pinprick treatment combined with fractional CO 2 laser are both safe and effective therapy for the treatment of atrophic acne scars.",2020,"Compared with the super pulse fractional CO 2 laser group, the decrease of ECCA scores, the increase of IVA scores and the patients' satisfaction were significantly higher and improvement on V-shaped and U-shaped acne scars was significantly better in the combined treatment group.","['20 patients with atrophic acne scars', 'atrophic acne scars', 'Atrophic Acne Scars']","['Pinprick Therapy Combined with Super Pulse Fractional CO 2 Laser', 'fractional CO 2 laser', 'pinprick therapy with fractional CO 2 laser']","['ECCA scores', 'clinical efficacy and safety', 'severe adverse reactions such as blister, infection or hypertrophic scars', ""ECCA scores, IVA scores, patients' satisfaction, VAS scores, and adverse reactions"", 'IVA scores', 'V-shaped and U-shaped acne scars']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439635', 'cui_str': 'V-shaped'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}]",20.0,0.0137452,"Compared with the super pulse fractional CO 2 laser group, the decrease of ECCA scores, the increase of IVA scores and the patients' satisfaction were significantly higher and improvement on V-shaped and U-shaped acne scars was significantly better in the combined treatment group.","[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Yiqiong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Qiongyan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Dermatology, the First Affiliated Hospital of Kunming Medical University, Kunming, 650032, P. R. China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13568'] 2745,32585803,Fostering Broad Oral Language Skills in Preschoolers from Low SES Background.,"Socioeconomic disparities increase the probability that children will enter school behind their more advantaged peers. Early intervention on language skills may enhance language and literacy outcomes, reduce the gap and, eventually, promote school readiness of low-SES (Socioeconomic Status) children. This study aimed to analyze the feasibility and effectiveness of a brief narrative-based intervention (treatment vs. control group) aimed to foster broad oral language skills in preschoolers (N = 69; Mean age = 5.5, SD = 4 months) coming from low-SES families. Moreover, it was analyzed whether children's initial vocabulary mediates the intervention's responsiveness. Results have shown that children in treatment group obtained greater gains than children in control group in almost all intervention-based measures. There is also some evidence for the generalizability of the intervention to other skills not directly trained during the intervention. Moreover, it was found that children's initial vocabulary mediates the intervention's responsiveness showing that children with high vocabulary made greater gains in higher-level components of language comprehension, whereas children with low vocabulary made higher gains in vocabulary. Taken together, our findings suggest that a relatively brief, but quite intensive narrative-based intervention, may produce improvements on broad oral language skills in preschoolers from low-SES backgrounds.",2020,Results have shown that children in treatment group obtained greater gains than children in control group in almost all intervention-based measures.,"['Preschoolers from Low SES ', 'preschoolers (N = 69; Mean age = 5.5, SD = 4 months) coming from low-SES families']",['brief narrative-based intervention (treatment vs. control group) aimed to foster broad oral language skills'],"['language skills may enhance language and literacy outcomes, reduce the gap and, eventually, promote school readiness of low-SES (Socioeconomic Status) children', 'broad oral language skills', 'feasibility and effectiveness']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",69.0,0.0211223,Results have shown that children in treatment group obtained greater gains than children in control group in almost all intervention-based measures.,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Dicataldo', 'Affiliation': 'Department of Development and Socialization Psychology, University of Padova, 35131 Padova, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Florit', 'Affiliation': 'Department of Human Sciences, University of Verona, 37129 Verona, Italy.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Roch', 'Affiliation': 'Department of Development and Socialization Psychology, University of Padova, 35131 Padova, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17124495'] 2746,32585833,Self-Reported Versus Observed Measures: Validation of Child Caregiver Food Hygiene Practices in Rural Malawi.,"Few studies have attempted to measure the differences between self-reported and observed food hygiene practices in a household setting. We conducted a study to measure the level of agreement between self-reported and observed food hygiene practices among child caregivers with children under the age of five years in rural Malawi. Fifty-eight child caregivers from an intervention and 29 from a control group were recruited into the study. At the end of a nine-month food hygiene intervention, household observations were conducted followed by self-reported surveys. Overall, practices were found to be more frequently reported than observed in both groups. However, the difference between self-reports and observed practices was minimal in the intervention compared to the control group. The odds ratio results confirm that more desirable practices were observed in the intervention group compared to the control group. Despite the effects of reactivity during observations, the study results imply that the intervention group did not just improve their knowledge, but also translated the messaging into better practice. Researchers and implementing agencies in water, sanitation and hygiene and food hygiene sector should ensure that interventions are context-appropriate, and that effective methods of observation are used to confirm any reported effects of an intervention.",2020,"Despite the effects of reactivity during observations, the study results imply that the intervention group did not just improve their knowledge, but also translated the messaging into better practice.","['Child Caregiver Food Hygiene Practices in Rural Malawi', 'child caregivers with children under the age of five years in rural Malawi', 'Fifty-eight child caregivers from an intervention and 29 from a control group were recruited into the study']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],58.0,0.0155271,"Despite the effects of reactivity during observations, the study results imply that the intervention group did not just improve their knowledge, but also translated the messaging into better practice.","[{'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), Polytechnic University of Malawi, Private Bag 303, Chichiri, Blantyre 3, Malawi.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tilley', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), Polytechnic University of Malawi, Private Bag 303, Chichiri, Blantyre 3, Malawi.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), Polytechnic University of Malawi, Private Bag 303, Chichiri, Blantyre 3, Malawi.'}]",International journal of environmental research and public health,['10.3390/ijerph17124498'] 2747,32585837,"Supplementation with Whey Protein, Omega-3 Fatty Acids and Polyphenols Combined with Electrical Muscle Stimulation Increases Muscle Strength in Elderly Adults with Limited Mobility: A Randomized Controlled Trial.","Age-related sarcopenia is a progressive and generalized skeletal muscle disorder associated with adverse outcomes. Herein, we evaluate the effects of a combination of electrical muscle stimulation (EMS) and a whey-based nutritional supplement (with or without polyphenols and fish oil-derived omega-3 fatty acids) on muscle function and size. Free-living elderly participants with mobility limitations were included in this study. They received 2 sessions of EMS per week and were randomly assigned to ingest an isocaloric beverage and capsules for 12 weeks: (1) carbohydrate + placebo capsules (CHO, n = 12), (2) whey protein isolate + placebo capsules (WPI, n = 15) and (3) whey protein isolate + bioactives (BIO) capsules containing omega-3 fatty acids, rutin, and curcumin (WPI + BIO, n = 10). The change in knee extension strength was significantly improved by 13% in the WPI + BIO group versus CHO on top of EMS, while WPI alone did not provide a significant benefit over CHO. On top of this, there was the largest improvement in gait speed (8%). The combination of EMS and this specific nutritional intervention could be considered as a new approach for the prevention of sarcopenia but more work is needed before this approach should be recommended. This trial was registered at the Japanese University Hospital Medical Information Network (UMIN) clinical trial registry (UMIN000008382).",2020,"The change in knee extension strength was significantly improved by 13% in the WPI + BIO group versus CHO on top of EMS, while WPI alone did not provide a significant benefit over CHO.","['Free-living elderly participants with mobility limitations', 'Elderly Adults with Limited Mobility']","['Supplementation with Whey Protein, Omega-3 Fatty Acids and Polyphenols Combined with Electrical Muscle Stimulation', 'isocaloric beverage and capsules for 12 weeks: (1) carbohydrate + placebo capsules (CHO, n = 12), (2) whey protein isolate + placebo capsules (WPI, n = 15) and (3) whey protein isolate + bioactives (BIO) capsules containing omega-3 fatty acids, rutin, and curcumin (WPI + BIO, n = 10', 'electrical muscle stimulation (EMS) and a whey-based nutritional supplement (with or without polyphenols and fish oil-derived omega-3 fatty acids']","['gait speed', 'change in knee extension strength']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700572', 'cui_str': 'Reduced mobility'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0035976', 'cui_str': 'Rutin'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",,0.0967564,"The change in knee extension strength was significantly improved by 13% in the WPI + BIO group versus CHO on top of EMS, while WPI alone did not provide a significant benefit over CHO.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Boutry-Regard', 'Affiliation': 'Nestlé Research, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Vinyes-Parés', 'Initials': 'VP', 'LastName': 'Gerard', 'Affiliation': 'Nestlé Health Science S.A., 1066 Epalinges, Switzerland.'}, {'ForeName': 'Breuillé', 'Initials': 'B', 'LastName': 'Denis', 'Affiliation': 'Nestlé Research, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Moritani', 'Initials': 'M', 'LastName': 'Toshio', 'Affiliation': 'Laboratory of Applied Physiology, Graduate School of Human and Environmental Studies, Kyoto University, Kyoto 606-8501, Japan.'}]",Nutrients,['10.3390/nu12061866'] 2748,32585854,"Omega-3 Eicosapentaenoic Acid (EPA) Rich Extract from the Microalga Nannochloropsis Decreases Cholesterol in Healthy Individuals: A Double-Blind, Randomized, Placebo-Controlled, Three-Month Supplementation Study.","The aim of this trial is to assess the effect of Almega ® PL on improving the Omega-3 Index, cardio-metabolic parameters, and other biomarkers in generally healthy individuals. The benefits of long-chain omega-3 fatty acids for cardiovascular health are primarily built upon mixtures of docosahexaenoic (DHA) and eicosapentaenoic acids (EPA). Highly purified EPA therapy has proven to be particularly effective in the treatment of cardiovascular disease, but less is known about the benefits of EPA-only supplementation for the general healthy population. Almega ® PL is a polar rich oil (>15%) derived from the microalga Nannochloropsis that contains EPA (>25%) with no DHA. Participants ( n = 120) were given a capsule of 1 g/day of either Almega ® PL or placebo for 12 weeks. Differences in the Omega-3 Index, cardiometabolic markers, and other general health indicators were measured at the baseline, six, and 12 weeks. Compared to the placebo group, Almega ® PL supplementation significantly increased the Omega-3 Index and EPA concentration from 4.96 ± 0.90 and 0.82 ± 0.37% at the baseline to 5.75 ± 0.90 and 1.27 ± 0.36 at week 12, respectively. Very-low-density lipoprotein cholesterol (VLDL) decreased by 25%, which resulted in a significant decrease in total cholesterol compared to the placebo. Interestingly, the decrease in VLDL was not associated with an increase in LDL, which seems to be a benefit associated with EPA-only based formulations. Collectively, these results show that Almega ® PL provides a natural EPA-only option to increase EPA and manage cholesterol levels in the general population.",2020,"Compared to the placebo group, Almega ® PL supplementation significantly increased the Omega-3 Index and EPA concentration from 4.96 ± 0.90 and 0.82 ± 0.37% at the baseline to 5.75 ± 0.90 and 1.27 ± 0.36 at week 12, respectively.","['generally healthy individuals', 'Participants ( n = 120', 'Healthy Individuals']","['Almega ® PL supplementation', 'Placebo', 'Omega-3 Eicosapentaenoic Acid (EPA', 'Highly purified EPA therapy', 'Almega ® PL', 'long-chain omega-3 fatty acids', 'Almega ® PL or placebo', 'placebo']","['total cholesterol', 'Omega-3 Index, cardiometabolic markers, and other general health indicators', 'Omega-3 Index, cardio-metabolic parameters', 'Omega-3 Index and EPA concentration', 'LDL', 'VLDL', 'Very-low-density lipoprotein cholesterol (VLDL', 'EPA and manage cholesterol levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]",120.0,0.41295,"Compared to the placebo group, Almega ® PL supplementation significantly increased the Omega-3 Index and EPA concentration from 4.96 ± 0.90 and 0.82 ± 0.37% at the baseline to 5.75 ± 0.90 and 1.27 ± 0.36 at week 12, respectively.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'RDC Clinical, Brisbane 4006, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Briskey', 'Affiliation': 'RDC Clinical, Brisbane 4006, Australia.'}, {'ForeName': 'Jakob O', 'Initials': 'JO', 'LastName': 'Nalley', 'Affiliation': 'Qualitas Health, Houston, TX 77056, USA.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Ganuza', 'Affiliation': 'Qualitas Health, Houston, TX 77056, USA.'}]",Nutrients,['10.3390/nu12061869'] 2749,32585907,Repeated Sprint Training vs. Repeated High-Intensity Technique Training in Adolescent Taekwondo Athletes-A Randomized Controlled Trial.,"This study investigated the effects of 4-weeks repeated sprint (RST) vs. repeated high-intensity-technique training (RTT) on physical performance. Thirty-six adolescent taekwondo athletes (age: 16 ± 1 yrs) were randomly assigned to RST (10 × 35 m sprint, 10 s rest), RTT (10 × 6 s Bandal-tchagui, 10 s rest) and control (control group (CG): no additional training) groups. Additionally, to their regular training, RST and RTT trained 2×/week for 4 weeks. Training load (TL), monotony, and strain were calculated using the rating of perceived exertion scale. The progressive specific taekwondo (PSTT), 20 m multistage shuttle run (SRT 20m ), 5 m shuttle run, agility T-test, taekwondo-specific agility (TSAT) and countermovement jump (CMJ) tests were performed before and after 4 weeks of training. Additionally, taekwondo athletes performed specific taekwondo exercises (i.e., repeated techniques for 10 s and 1 min). From week 1, mean TL increased continuously to week 4 and monotony and strain were higher at weeks 3 and 4 ( p < 0.001). VO 2max calculated from SRT 20m and PSTT increased for RST and RTT in comparison to CG ( p < 0.001). Agility performance during T-test and TSAT ( p < 0.01) improved in RTT. The number of performed techniques during the 10 s specific exercise increased in RTT and RST ( p < 0.01) for the dominant leg and in RTT for the non-dominant leg ( p < 0.01). The number of techniques during the 1 min specific exercise was higher in RST and RTT compared to CG for the dominant leg ( p < 0.001). Delta lactate at post-training was lower for RTT for both legs compared to RST and CG ( p < 0.01). It is important to include a low-volume high-intensity training based on repeated sprint running or repeated technique in the training programs of adolescent taekwondo athletes.",2020,Delta lactate at post-training was lower for RTT for both legs compared to RST and CG ( p < 0.01).,"['adolescent taekwondo athletes', 'Thirty-six adolescent taekwondo athletes (age: 16 ± 1 yrs', 'Adolescent Taekwondo Athletes']","['specific taekwondo exercises', 'control (control group (CG): no additional training', 'Repeated Sprint Training vs. Repeated High-Intensity Technique Training', 'RST ', '4-weeks repeated sprint (RST) vs. repeated high-intensity-technique training (RTT']","['RTT and RST', 'mean TL', 'Training load (TL), monotony, and strain', 'Delta lactate', 'physical performance', 'number of techniques during the 1 min specific exercise', 'Agility performance', 'VO 2max calculated from SRT 20m and PSTT', 'agility T-test, taekwondo-specific agility (TSAT) and countermovement jump (CMJ) tests']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",36.0,0.0261048,Delta lactate at post-training was lower for RTT for both legs compared to RST and CG ( p < 0.01).,"[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Ouergui', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Messaoudi', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Matthias Oliver', 'Initials': 'MO', 'LastName': 'Wagner', 'Affiliation': 'Department of Sport Science, Bundeswehr University Munich, 85579 Neubiberg, Germany.'}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Bouassida', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Ezdine', 'Initials': 'E', 'LastName': 'Bouhlel', 'Affiliation': 'Laboratory of Cardio-Circulatory, Respiratory, Metabolic and Hormonal Adaptations to Muscular Exercise, Faculty of Medicine, Ibn El Jazzar, Sousse 4000, Tunisia.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'Martial Arts and Combat Sports Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo 05508-030, Brazil.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Engel', 'Affiliation': 'Department of Sport Science, Bundeswehr University Munich, 85579 Neubiberg, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17124506'] 2750,32586026,The Office Work and Stretch Training (OST) Study: An Individualized and Standardized Approach to Improve the Quality of Life in Office Workers.,"In the context of workplace health promotion, physical activity programs have been shown to reduce musculoskeletal diseases and stress, and to improve the quality of life. The aim of this study was to examine the effects of using the ""five-Business"" stretch training device for office workers on their quality of life. A total of 313 office workers (173m/137f) participated voluntarily in this intervention-control study with an average age of 43.37 ± 11.24 (SD) years, 175.37 ± 9.35 cm in height and 75.76 ± 15.23 kg in weight, with an average BMI of 24.5 ± 3.81 kg/m 2 . The participants completed the stretch training twice a week for approximately 10 minutes for a duration of 12 weeks. The SF-36 questionnaire was used to evaluate the effectiveness of the intervention at baseline and after 12 weeks. Significantly improved outcomes in mental sum score ( p = 0.008), physical functioning ( p < 0.001), bodily pain ( p = 0.01), vitality ( p = 0.025), role limitations due to physical problems ( p = 0.018) and mental health ( p = 0.012) were shown after the stretching training. The results suggest that a 12-week stretching program for office desk workers is suitable to improve significantly their health-related quality of life.",2020,"Significantly improved outcomes in mental sum score ( p = 0.008), physical functioning ( p < 0.001), bodily pain ( p = 0.01), vitality ( p = 0.025), role limitations due to physical problems ( p = 0.018) and mental health ( p = 0.012) were shown after the stretching training.","['Office Workers', 'A total of 313 office workers (173m/137f) participated voluntarily in this intervention-control study with an average age of 43.37 ± 11.24 (SD) years, 175.37 ± 9.35 cm in height and 75.76 ± 15.23 kg in weight, with an average BMI of 24.5 ± 3.81 kg/m 2 ']","['stretch training', 'Stretch Training', 'five-Business"" stretch training device']","['quality of life', 'Quality of Life', 'health-related quality of life', 'vitality', 'physical functioning', 'mental health', 'bodily pain', 'mental sum score']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",313.0,0.0320827,"Significantly improved outcomes in mental sum score ( p = 0.008), physical functioning ( p < 0.001), bodily pain ( p = 0.01), vitality ( p = 0.025), role limitations due to physical problems ( p = 0.018) and mental health ( p = 0.012) were shown after the stretching training.","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Holzgreve', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Maltry', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Hänel', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Daimler AG, 70171 Stuttgart, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bader', 'Affiliation': 'Daimler AG, 70171 Stuttgart, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Frei', 'Affiliation': 'Mercedes-Benz AG, 76437 Rastatt, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Institute of Biostatistics and Mathematical Modeling, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'David Alexander', 'Initials': 'DA', 'LastName': 'Groneberg', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ohlendorf', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'van Mark', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17124522'] 2751,32586063,Physical Activity Levels of Chilean Children in a National School Intervention Programme. A Quasi-Experimental Study.,"Background . Recess is a great opportunity to interrupt sedentary behaviour and increase moderate-to-vigorous physical activity (MVPA) in schoolchildren. This quasi-experimental study aimed to compare the levels of physical activity (PA) during the school day of children in a school intervention programme vs. those in a control group, and to determine compliance with MVPA recommendations. Methods. A sample of 154 schoolchildren (6-12 years old) was obtained from several schools (70 with the intervention and 84 controls). This programme was structured with a duration of 90 min/session and performed three times/week. PA levels were recorded with triaxial accelerometers during the school day: during recess, during a PA session or physical education session (PE), and during lunchtime. No pre-intervention evaluation was performed. Results. The MVPA of the control group was higher than that of the intervention group during the first recess ( p < 0.001). None of the groups complied with the recommendations for steps during the PA or PE sessions. During the PA session, sedentary time was lower and MVPA was higher, in the intervention group than in the control group. Fifty percent of the children from the intervention group complied with the MVPA recommendations, vs. 22.7% of those in the control group. Conclusions. The schoolchildren in the intervention group performed more MVPA than those in the control group. Future interventions could include other periods, such as recess and lunchtime, which are opportunities for improving the MVPA levels of schoolchildren.",2020,"During the PA session, sedentary time was lower and MVPA was higher, in the intervention group than in the control group.","['schoolchildren', '154 schoolchildren (6-12 years old) was obtained from several schools (70 with the intervention and 84 controls', 'Chilean Children in a National School Intervention Programme']",['MVPA'],"['levels of physical activity (PA', 'Physical Activity Levels', 'PA levels']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015737', 'cui_str': 'National Government'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",154.0,0.0162662,"During the PA session, sedentary time was lower and MVPA was higher, in the intervention group than in the control group.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso 2340025, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cristi-Montero', 'Affiliation': 'IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso 2340025, Chile.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Castro-Piñero', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cadiz, 11003 Cadiz, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124529'] 2752,32586077,Post-activation potentiation effects of Back Squat and Barbell Hip Thrust exercise on vertical jump and sprinting performance.,"BACKGROUND This study aimed to determine and compare the post-activation potentiation (PAP) effects of the Back Squat (SQ-PAP) and Hip Thrust (HT-PAP) exercises in terms of vertical jump height (VJ), 20-yard dash and 40-yard dash time in physically active university students. Considering the Force-vector theory, it was hypothesized that HT-PAP would induce greater potentiation for 40 yard dash than SQ-PAP whereas SQ-PAP would induce greater potentiation for 20-yard dash and VJ than HT-PAP. METHODS Seventeen kinesiology and exercise science students (8 male and 9 female) who resistance train at least 3 times/week (age, 21.71± 1.49 years; body mass, 75.58± 11.89 kg; height,173.98± 11.88 cm and training experience 5.47±2.00 years) joined this study. They performed three experimental sessions namely; Baseline (BL), SQ-PAP loading session and HT-PAP loading session with 48 hours interval with a randomized open crossover study design. BL session was also accepted as control and familiarization session. SQ-PAP and HT-PAP exercises were performed roughly at 90 % of 1 Repetition maximum (1 RM) of the subjects with three repetitions. Subjects were tested for vertical jump height (VJ), 20-yard dash and 40- yard dash time before and 8 minutes after each PAP loading exercise. RESULTS Statistical analysis revealed that the potentiation effects of SQ-PAP and HT-PAP exercises on VJ height, 20-yard and 40-yard dash were similar that none of the loading exercises with 8 min rest interval had any increasing or detrimental performance effect on VJ (p=0.923), 20-yard dash (p=0.133) as well 40-yard dash time (p=0.570). CONCLUSIONS These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study. Although no acute potentiation effect has been found, this study also shows that SQ-PAP, HT-PAP exercises can be used interchangeably and safely to avoid training monotony during longer training periods for chronic adaptations.",2020,"These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study.","['physically active university students', 'Seventeen kinesiology and exercise science students (8 male and 9 female) who resistance train at least 3 times/week (age, 21.71± 1.49 years; body mass, 75.58± 11.89 kg; height,173.98± 11.88 cm and training experience 5.47±2.00 years) joined this study']","['Back Squat and Barbell Hip Thrust exercise', 'Back Squat (SQ-PAP) and Hip Thrust (HT-PAP) exercises']","['vertical jump height (VJ), 20-yard dash and 40-yard dash time', 'vertical jump and sprinting performance', 'VJ height, 20-yard dash and 40-yard dash time', 'VJ height, 20-yard and 40-yard dash', 'SQ-PAP and HT-PAP exercises', 'vertical jump height (VJ), 20-yard dash and 40- yard dash time']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439205', 'cui_str': 'yd'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0202927,"These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study.","[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Atalağ', 'Affiliation': ""Department of Kinesiology and Exercise Sciences, University of Hawai'i at Hilo, Hilo, HI, USA - ozan@hawaii.edu.""}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Kurt', 'Affiliation': 'Department of Coaching Education, School of Kirkpinar Physical Education and Sports, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Evelin', 'Initials': 'E', 'LastName': 'Solyomvari', 'Affiliation': ""Department of Kinesiology and Exercise Sciences, University of Hawai'i at Hilo, Hilo, HI, USA.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Sands', 'Affiliation': ""Department of Kinesiology and Exercise Sciences, University of Hawai'i at Hilo, Hilo, HI, USA.""}, {'ForeName': 'Ciera', 'Initials': 'C', 'LastName': 'Cline', 'Affiliation': ""Department of Kinesiology and Exercise Sciences, University of Hawai'i at Hilo, Hilo, HI, USA.""}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10888-0'] 2753,32586078,Repetitions in reserve vs maximum effort resistance training programs in youth female athletes.,"BACKGROUND This study aimed to analyze and compare the effects of two different resistance training programs. METHODS Fourteen under-17 youth female basketball players were randomly assigned to repetitions in reserve (RIR, n = 7) or maximum effort (RM, n = 7) resistance training programs. The programs consisted of 3-4 sets of 4 exercises x 7-10 repetitions with 2 min of passive recovery between sets and exercises, twice a week for a period of 8 weeks. The RIR group was instructed to perform the exercises with 3 repetitions remaining (rate of perceived exertion [RPE] = 7). The physical assessment included jumping, agility, and sprinting tests. Moreover, the maximum strength (one maximum-repetition [1-RM]) and muscle power output at 60% 1RM were assessed for back-squat and bench-press exercises. RESULTS The within-group analysis showed improvements in all tests for both groups (RIR = 1.3-43.9%; RM = 1.3-17.2%). Between-group analyses showed a substantially better performance of the RER group in the countermovement jump (ES = 0.80), V-cut (ES = 0.72), T-test (ES = 1.39), and in the averagepower bench-press (ES = 0.60), and 1RM bench-press (ES = 0.60, p < 0.05). a significant interaction effect (group x time) on 1-RM bench-press (F = 8.07, p < 0.05, η2p = 0.40), favoring RIR group. CONCLUSIONS This study reports for the first time that the use of RIR-based RPE resistance training protocol promotes improvements in high-intensity actions (sprinting, jumping, and cutting), muscle power output, and maximum strength, particularly in youth athletes. Considering the advantages of non-failure training, RIR training may be a suitable in-season training strategy. However, more studies are needed to confirm whether the training-induced benefits of this novel training strategy are significantly better as compared to other approaches.",2020,"Between-group analyses showed a substantially better performance of the RER group in the countermovement jump (ES = 0.80), V-cut (ES = 0.72), T-test (ES = 1.39), and in the averagepower bench-press (ES = 0.60), and 1RM bench-press (ES = 0.60, p < 0.05).","['Fourteen under-17 youth female basketball players', 'youth athletes', 'youth female athletes']","['maximum effort (RM, n = 7) resistance training programs', 'RIR-based RPE resistance training protocol', 'RIR training']","['physical assessment included jumping, agility, and sprinting tests', '1-RM bench-press', 'high-intensity actions (sprinting, jumping, and cutting), muscle power output, and maximum strength', 'maximum strength (one maximum-repetition [1-RM]) and muscle power output']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",7.0,0.0492495,"Between-group analyses showed a substantially better performance of the RER group in the countermovement jump (ES = 0.80), V-cut (ES = 0.72), T-test (ES = 1.39), and in the averagepower bench-press (ES = 0.60), and 1RM bench-press (ES = 0.60, p < 0.05).","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arede', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal - jorge_arede@hotmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vaz', 'Affiliation': 'University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': 'Faculty of Health Sciences, University of San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Balsalobre-Fernandéz', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Varela-Olalla', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Madruga-Parera', 'Affiliation': 'University School of Health and Sport (EUSES), University of Girona, Girona, Spain.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10907-1'] 2754,32586212,Does firefighters' physical fitness influence their cardiac parasympathetic reactivation? Analysis with post-exercise heart rate variability and ultra-short-term measures.,"Purpose . This study assessed the influence of firefighters' physical fitness on performances and parasympathetic reactivation in rescue interventions, and tested the validity of post-exercise ultra-short-term heart rate variability. Methods . Twenty-four firefighters were assigned to two groups based on their fitness and performed three simulated interventions. The mean completion time was recorded. The post-exercise root mean square of successive differences of R-R intervals (LnRMSSD) was determined from both criterion (between 5 and 10 min) and ultra-short-term (every 1-min segment from minutes 0-6) analyses. Results . Completion time was better for the highest fitness group in the three simulated interventions while post-exercise LnRMSSD was not influenced by the firefighters' fitness. Reliability between ultra-short-term and criterion analyses differed between the segments tested; minute 5-6 revealed the highest intra-class correlations (0.86-0.97). Concerning sensitivity of both analyses, the criterion analysis revealed differences between the three rescue interventions and the fitness test, but these results were not observed with ultra-short-term measures. Conclusions . Fitness was associated with firefighters' performances but not with parasympathetic reactivation in the firefighting intervention. The ultra-short-term measures do not seem to be a suitable post-exercise LnRMSSD analysis because of the low sensitivity to reveal differences among exercise conditions.",2020,Fitness was associated with firefighters' performances but not with parasympathetic reactivation in the firefighting intervention.,['Twenty-four firefighters'],[],"['Completion time', 'mean completion time']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",24.0,0.0210115,Fitness was associated with firefighters' performances but not with parasympathetic reactivation in the firefighting intervention.,"[{'ForeName': 'Philémon', 'Initials': 'P', 'LastName': 'Marcel-Millet', 'Affiliation': 'Department of Sport and Performance, University of Bourgogne-Franche-Comte, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Ravier', 'Affiliation': 'Department of Sport and Performance, University of Bourgogne-Franche-Comte, France.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Esco', 'Affiliation': 'Department of Kinesiology, University of Alabama, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Groslambert', 'Affiliation': 'Department of Sport and Performance, University of Bourgogne-Franche-Comte, France.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2020.1738689'] 2755,32481255,A clinical study on safety and efficacy of Naesohwajung-tang on functional dyspepsia.,"BACKGROUND Functional dyspepsia (FD) is a chronic gastrointestinal disorder diagnosed with dyspeptic symptoms, such as recurrent or persistent postprandial fullness, epigastric pain, burning, and early satiety without any evidence of structural abnormality. In traditional Korean medicine, herbal remedies are one of the preferred treatments for gastrointestinal symptoms. Among them, Naesohwajung-tang (NHT) has been frequently prescribed to improve dyspeptic symptoms for a long time. However, the safety and efficacy of NHT still remain unclear. Therefore, this study aims to evaluate the safety and efficacy of NHT in patients with FD using a randomized controlled trial. METHODS This is a protocol for a multi-center, randomized, double-blind, placebo-controlled trial. Total 116 participants aged between 19 and 75 years diagnosed with FD according to the Rome IV diagnosis criteria will be recruited at two Korean medicine hospitals. Eligible participants will be randomly assigned to either a NHT group or a placebo group in a 1:1 ratio. Each participant will be instructed to take NHT or placebo granules three times a day for 4 weeks. The primary outcome is the change in the total dyspepsia symptom score to confirm the efficacy of NHT. The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments. Adverse events will be evaluated at every visit. The primary endpoint will be measured at week 4, and then re-evaluated at week 8 through a follow-up phone visit. DISCUSSION This trial will evaluate the safety and efficacy of NHT as a treatment of FD. The results of this trial will not only verify whether NHT improves FD symptoms and gastric myoelectrical activity, but also clarify those correlations. TRIAL REGISTRATION NUMBER CRIS KCT0003405.",2020,"The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments.","['Eligible participants', 'Total 116 participants aged between 19 and 75 years diagnosed with FD according to the Rome IV diagnosis criteria will be recruited at two Korean medicine hospitals', 'patients with FD']","['NHT', 'Naesohwajung-tang', 'Naesohwajung-tang (NHT', 'NHT or placebo', 'placebo']","['total dyspepsia symptom score', 'efficacy of NHT', 'functional dyspepsia', 'dyspeptic symptoms', 'Adverse events', 'overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments', 'FD symptoms and gastric myoelectrical activity', 'safety and efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430689', 'cui_str': 'Electromyography of stomach'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",116.0,0.659328,"The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments.","[{'ForeName': 'Na-Yeon', 'Initials': 'NY', 'LastName': 'Ha', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seulki', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seok-Jae', 'Initials': 'SJ', 'LastName': 'Ko', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000019910'] 2756,32481440,Tamoxifen for amyotrophic lateral sclerosis: A randomized double-blind clinical trial.,"INTRODUCTION Amyotrophic lateral sclerosis (ALS) is the most common cause of motor neuron disease, and effective treatment for ALS is still lacking. Transactive response (TAR) -DNA-binding protein-43 (TDP-43) is aggregated in the neurons of ALS patients. Animal studies shown TDP-43 aggregation can be attenuated by enhancing autophagy by tamoxifen. However, its beneficial effects for ALS patients remain unknown. METHODS Eighteen patients with ALS without mutations in superoxide dismutase-1 (SOD-1) or fused in sarcoma (FUS) genes were randomly assigned into the tamoxifen 40 mg/day or placebo group in a double-blinded manner and all were given riluzole twice daily. Participants were followed up at 1, 3, 6, and 12 months. The primary end point was time to death or dependence on mechanical ventilation. Secondary end points were decline of the revised ALS Functional Rating Scale (ALSFRS-R) score and pulmonary function measured by forced vital capacity (FVC). RESULTS Ten participants were randomly assigned in the treatment group with tamoxifen, 7 finished trial, 1 reach primary endpoint; while 8 participants in the placebo group, 2 finished trial and 2 reach primary end point. The proportion of participants reaching the primary end point was lower in the tamoxifen group but did not reach statistical significance. At the 1-, 3-, and 6-month follow-up, the average decline rates of the ALSFRS-R score were slower in the tamoxifen group. No significant difference was observed in FVC and ALSFRS-R score at 12 months between groups. CONCLUSION Tamoxifen exerted only a modest effect on attenuate progression for 6 months in this small trial. Additional larger scale studies should be necessary to confirm whether enhancing autophagy can attenuate ALS progression.",2020,"No significant difference was observed in FVC and ALSFRS-R score at 12 months between groups. ","['Eighteen patients with ALS without mutations in superoxide dismutase-1', 'neurons of ALS patients', 'amyotrophic lateral sclerosis']","['riluzole', 'Tamoxifen', 'tamoxifen 40\u200amg/day or placebo', 'tamoxifen', 'placebo']","['Transactive response (TAR) -DNA-binding protein-43 (TDP-43', 'FVC and ALSFRS-R score', 'decline of the revised ALS Functional Rating Scale (ALSFRS-R) score and pulmonary function measured by forced vital capacity (FVC', 'average decline rates of the ALSFRS-R score', 'attenuate progression', 'time to death or dependence on mechanical ventilation']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0669516', 'cui_str': 'Superoxide Dismutase 1'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1132688', 'cui_str': 'Tamoxifen 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012940', 'cui_str': 'DNA Binding Protein'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439857', 'cui_str': 'Dependence'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",1.0,0.425237,"No significant difference was observed in FVC and ALSFRS-R score at 12 months between groups. ","[{'ForeName': 'Po-Chih', 'Initials': 'PC', 'LastName': 'Chen', 'Affiliation': 'Neurology Department, Shuang-Ho Hospital.'}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Hsieh', 'Affiliation': 'PhD Program for Neural Regenerative Medicine, College of Medical Science and Technology, Taipei Medical University and National Health Research Institutes.'}, {'ForeName': 'Chi-Chen', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'PhD Program for Neural Regenerative Medicine, College of Medical Science and Technology, Taipei Medical University and National Health Research Institutes.'}, {'ForeName': 'Chaur-Jong', 'Initials': 'CJ', 'LastName': 'Hu', 'Affiliation': 'Neurology Department, Shuang-Ho Hospital.'}]",Medicine,['10.1097/MD.0000000000020423'] 2757,32485917,Tibial Nerve Block: Supramalleolar or Retromalleolar Approach? A Randomized Trial in 110 Participants.,"Of the five nerves that innervate the foot, the one in which anesthetic blocking presents the greatest difficulty is the tibial nerve. The aim of this clinical trial was to establish a protocol for two tibial nerve block anesthetic techniques to later compare the anesthetic efficiency of retromalleolar blocking and supramalleolar blocking in order to ascertain whether the supramalleolar approach achieved a higher effective blocking rate. A total of 110 tibial nerve blocks were performed. Location of the injection site was based on a prior ultrasound assessment of the tibial nerve. The block administered was 3 mL of 2% mepivacaine. The two anesthetic techniques under study provided very similar clinical results. The tibial nerve success rate was 81.8% for the retromalleolar technique and 78.2% for the supramalleolar technique. No significant differences in absolute latency time ( p = 0.287), percentage of effective nerve blocks ( p = 0.634), anesthetic block duration ( p = 0.895), or pain level during puncture ( p = 0.847) were found between the two techniques. The greater ease in locating the tibial nerve at the retromalleolar approach could suggest that this is the technique of choice for tibial nerve blocking, especially in the case of professionals new to the field. The supramalleolar technique could be worth considering for those more experienced professionals.",2020,"No significant differences in absolute latency time ( p = 0.287), percentage of effective nerve blocks ( p = 0.634), anesthetic block duration ( p = 0.895), or pain level during puncture ( p = 0.847) were found between the two techniques.",['110 Participants'],['mepivacaine'],"['absolute latency time', 'pain level', 'tibial nerve success rate', 'anesthetic block duration', 'percentage of effective nerve blocks']","[{'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]",110.0,0.0376973,"No significant differences in absolute latency time ( p = 0.287), percentage of effective nerve blocks ( p = 0.634), anesthetic block duration ( p = 0.895), or pain level during puncture ( p = 0.847) were found between the two techniques.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Benimeli-Fenollar', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Montiel-Company', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Almerich-Silla', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Cibrián', 'Affiliation': 'Department of Physiology, University of Valencia, c/Blasco Ibánez, 15, 46010 Valencia, Spain.'}, {'ForeName': 'Cecili', 'Initials': 'C', 'LastName': 'Macián-Romero', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113860'] 2758,32485641,"Caloric restriction, resting metabolic rate and cognitive performance in Non-obese adults: A post-hoc analysis from CALERIE study.","Physical activity (PA) has been proposed as a determinant of cognitive function and is one component of energy balance (EB). EB is the difference between energy intake (EI) and the total daily energy expenditure (TDEE). TDEE is a combination of resting metabolic rate (RMR), thermic effect of food and PA. The potential role of each of these components on cognitive function has not yet been systemically investigated. We aim to evaluate the association between each component of EB on cognition, using baseline and longitudinal data from a clinical trial of caloric restriction (CR). This is a parallel-group, randomized clinical trial comparing two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI ≥ 22 kg/m2 and <28 kg/m2. Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content were evaluated, as well as RMR, TDEE, cognitive performance and baseline energy intake. A 30 min/day of a moderate level on a minimum of 5 days/week was advised as PA measure. Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass. EB and homeostasis are crucial to modulate the RMR. Moreover, RMR presents an important influence on cognitive function in individuals submitted to CR in a long term.",2020,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","['two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI', 'Non-obese adults']","['TDEE', 'Physical activity (PA', 'caloric restriction (CR']","['cognitive performance', 'RMR, TDEE, cognitive performance and baseline energy intake', 'total daily energy expenditure (TDEE', 'cognitive function', 'resting metabolic rate (RMR), thermic effect of food and PA', 'Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content', 'cognitive performance and the RMR', 'Caloric restriction, resting metabolic rate and cognitive performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]",220.0,0.044031,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","[{'ForeName': 'Ruth Bartelli', 'Initials': 'RB', 'LastName': 'Grigolon', 'Affiliation': 'Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil; Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada; Centre for Neuroscience Studies (CNS), Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Alisson Paulino', 'Initials': 'AP', 'LastName': 'Trevizol', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada; Brain and Cognition Foundation, Toronto, ON, Canada.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada. Electronic address: rodrigomansur71@uol.com.br.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.018'] 2759,32485656,Impulsiveness as a moderator of amphetamine treatment response for cocaine use disorder among ADHD patients.,"BACKGROUND Amphetamines are a first-line treatment for ADHD and have shown promise for the treatment of cocaine use disorder (CUD), both alone and with comorbid ADHD. Impulsiveness is a key aspect of both ADHD and substance use disorders. We sought to understand the role of baseline impulsiveness in the treatment of comorbid CUD and ADHD. METHODS In a post hoc analysis (N = 76) of a 14-week, double-blind, randomized, placebo-controlled trial of mixed amphetamine salts-extended release (MAS-ER) for comorbid ADHD and CUD, we examined the relationship between treatment response and participants' baseline Barratt Impulsiveness Scale (BIS-11) score by comparing those with scores below versus above the median. In the original trial, participants received daily 60 mg MAS-ER, 80 mg MAS-ER, or placebo, in conjunction with cognitive behavioral therapy. RESULTS The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). CONCLUSIONS The results show an association between higher within-group trait impulsiveness, as measured by the BIS-11, and response to MAS-ER for CUD in a cohort with comorbid ADHD. This result further demonstrates that impulsiveness is an important factor when considering treatment options for patients with CUD and that higher baseline impulsiveness may predict response to treatment with psychostimulants for CUD.",2020,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). ","['ADHD patients', 'patients with CUD']","['mixed amphetamine salts-extended release (MAS-ER', 'daily 60\u2009mg MAS-ER, 80\u2009mg\u2009MAS-ER, or placebo, in conjunction with cognitive behavioral therapy', 'amphetamine', 'placebo']",['baseline Barratt Impulsiveness Scale (BIS-11) score'],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.145481,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). ","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grabowski', 'Affiliation': 'Department of Psychiatry, University of Minnesota Twin Cities, Minneapolis, MN, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108082'] 2760,32581088,Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.,"OBJECTIVES Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial. METHODS Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m 2 ) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse. RESULTS 188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections. CONCLUSIONS This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.",2020,"41 severe adverse events occurred in 27 patients, including 13 severe infections. ","['Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis', 'patients with relapsing AAV treated with', 'patients enrolled into the induction phase of the RITAZAREM trial', '188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years', 'patients with AAV who have relapsed, with a similar safety profile to previous studies']","['cyclophosphamide', 'rituximab and glucocorticoids', 'Rituximab', 'remission-induction therapy with rituximab (4×375\u2009mg/m 2 ) and a higher or lower dose glucocorticoid regimen', 'rituximab in conjunction with glucocorticoids', 'rituximab']",['41 severe adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",188.0,0.0880274,"41 severe adverse events occurred in 27 patients, including 13 severe infections. ","[{'ForeName': 'Rona M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'University of Cambridge, Cambridge, UK ronasmith@doctors.net.uk.'}, {'ForeName': 'Rachel Bronwen', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Nodale', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Aljayyousi', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Camilleri', 'Affiliation': 'Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chee Kay', 'Initials': 'CK', 'LastName': 'Cheung', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Vimal', 'Initials': 'V', 'LastName': 'Derebail', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Doulton', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.'}, {'ForeName': 'Lindsy', 'Initials': 'L', 'LastName': 'Forbess', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Furuta', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Gewurz-Singer', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Klocke', 'Affiliation': 'Dudley Group NHS Foundation Trust, Dudley, West Midlands, UK.'}, {'ForeName': 'Curry', 'Initials': 'C', 'LastName': 'Koening', 'Affiliation': 'University of Utah Vasculitis Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Komagata', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Rheumatology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Raashid Ahmed', 'Initials': 'RA', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science (NDORMs), University of Oxford, Oxford, UK.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama Universty Hospital, Okayama, Japan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'McAlear', 'Affiliation': 'Division of Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monach', 'Affiliation': 'Division of Rheumatology, VA Boston Healthcare System, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Moreland', 'Affiliation': 'University of Pittsburg, Pittsburg, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mynard', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nachman', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Rennie L', 'Initials': 'RL', 'LastName': 'Rhee', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'HSS, New York, New York, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Weisman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wroe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, Middlesbrough, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216863'] 2761,32581112,"A genetic risk score to personalize prostate cancer screening, applied to population data.","BACKGROUND A polygenic hazard score (PHS)-the weighted sum of 54 SNP genotypes-was previously validated for association with clinically significant prostate cancer and for improved prostate cancer screening accuracy. Here, we assess the potential impact of PHS-informed screening. METHODS UK population incidence data (Cancer Research UK) and data from the Cluster Randomized Trial of PSA Testing for Prostate Cancer were combined to estimate age-specific clinically significant prostate cancer incidence (Gleason≥7, stage T3-T4, PSA ≥10, or nodal/distant metastases). Using hazard ratios estimated from the ProtecT prostate cancer trial, age-specific incidence rates were calculated for various PHS risk percentiles. Risk-equivalent age-when someone with a given PHS percentile has prostate cancer risk equivalent to an average 50-year-old man (50-years-standard risk)-was derived from PHS and incidence data. Positive predictive value (PPV) of PSA testing for clinically significant prostate cancer was calculated using PHS-adjusted age groups. RESULTS The expected age at diagnosis of clinically significant prostate cancer differs by 19 years between the 1st and 99th PHS percentiles: men with PHS in the 1st and 99th percentiles reach the 50-years-standard risk level at ages 60 and 41, respectively. PPV of PSA was higher for men with higher PHS-adjusted age. CONCLUSIONS PHS provides individualized estimates of risk-equivalent age for clinically significant prostate cancer. Screening initiation could be adjusted by a man's PHS. IMPACT Personalized genetic risk assessments could inform prostate cancer screening decisions.",2020,"PPV of PSA was higher for men with higher PHS-adjusted age. ","['UK population incidence data (Cancer Research UK) and data from the Cluster Randomized Trial of PSA Testing for Prostate Cancer were combined to estimate age-specific clinically significant prostate cancer incidence (Gleason≥7, stage T3-T4, PSA ≥10, or nodal/distant metastases', 'men with higher PHS-adjusted age']",[],['PPV of PSA'],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0475374', 'cui_str': 'T3 category'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",,0.0430511,"PPV of PSA was higher for men with higher PHS-adjusted age. ","[{'ForeName': 'Minh-Phuong', 'Initials': 'MP', 'LastName': 'Huynh-Le', 'Affiliation': 'Radiation Medicine and Applied Sciences, University of California, San Diego.'}, {'ForeName': 'Chun Chieh', 'Initials': 'CC', 'LastName': 'Fan', 'Affiliation': 'Center for Multimodal Imaging and Genetics, University of California, San Diego.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Karunamuni', 'Affiliation': 'Radiation Medicine and Applied Sciences, University of California, San Diego.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Medical School, University of Bristol.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgery, University of Oxford.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'School of Social and Community Medicine, University of Bristol.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford.'}, {'ForeName': 'J Kellogg Kellogg', 'Initials': 'JKK', 'LastName': 'Parsons', 'Affiliation': 'Urology, University of California, San Diego.'}, {'ForeName': 'Rosalind A', 'Initials': 'RA', 'LastName': 'Eeles', 'Affiliation': 'Institute of Cancer Research.'}, {'ForeName': 'Douglas F', 'Initials': 'DF', 'LastName': 'Easton', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, Department of Oncology, University of Cambridge.'}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Kote-Jarai', 'Affiliation': 'Institute of Cancer Research.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Amin Al Olama', 'Affiliation': 'University of Cambridge.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Benlloch Garcia', 'Affiliation': 'University of Cambridge.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Muir', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Grönberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Wiklund', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Aly', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schleutker', 'Affiliation': 'Institute of Biomedicine, University of Turku.'}, {'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Sipeky', 'Affiliation': 'Institute of Biomedicine, University of Turku.'}, {'ForeName': 'Teuvo', 'Initials': 'T', 'LastName': 'Tammela', 'Affiliation': 'Tampere University Hospital, Department of Urology.'}, {'ForeName': 'Børge Grønne', 'Initials': 'BG', 'LastName': 'Nordestgaard', 'Affiliation': 'Department of Clinical Biochemistry, Herlev Hospital, Copenhagen University Hospital.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Key', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Travis', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford.'}, {'ForeName': 'Paul D P', 'Initials': 'PDP', 'LastName': 'Pharoah', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, Department of Oncology, University of Cambridge.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Pashayan', 'Affiliation': 'Department of Applied Health Research, University College London.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Cancer Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Thibodeau', 'Affiliation': 'Molecular Genetics Laboratory, Department of Laboratory Medicine and Pathology, Mayo Clinic.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'McDonnell', 'Affiliation': 'Health Science Research, Mayo Clinic.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Schaid', 'Affiliation': 'Health Sciences Research, Mayo Clinic.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Maier', 'Affiliation': 'Diagnostik Humangenetik, Humangenetik Tuebingen.'}, {'ForeName': 'Walther', 'Initials': 'W', 'LastName': 'Vogel', 'Affiliation': 'Universität Ulm, Institut für Humangenetik.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Luedeke', 'Affiliation': 'Diagnostics, genetikum.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Herkommer', 'Affiliation': 'Department of Urology, Klinikum rechts der Isar der TU Muenchen.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Department of Urology, Brigham and Women's Hospital.""}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Cybulski', 'Affiliation': 'Pomeranian Medical University.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Wokolorczyk', 'Affiliation': 'Pomeranian Medical University.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kluzniak', 'Affiliation': 'Pomeranian Medical University.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cannon-Albright', 'Affiliation': 'Genetic Epidemiology, Department of Internal Medicine, University of Utah School of Medicine.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Brenner', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Schöttker', 'Affiliation': 'Clinica Epidemiology and Aging Research, German Cancer Research Center.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Holleczek', 'Affiliation': 'Saarland Cancer Registry, Saarland Cancer Registry.'}, {'ForeName': 'Jong Y', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Cancer Epidemiology, Moffitt Cancer Center.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Sellers', 'Affiliation': 'N/A, N/A.'}, {'ForeName': 'Hui-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Biostatistics, Louisiana State University Health Sciences Center New Orleans.'}, {'ForeName': 'Chavdar Kroumov', 'Initials': 'CK', 'LastName': 'Slavov', 'Affiliation': 'Department of Urology, Alexandrovska University Hospital, Medical University.'}, {'ForeName': 'Radka P', 'Initials': 'RP', 'LastName': 'Kaneva', 'Affiliation': 'Molecular Medicine Center, Department of Medical Chemistry and Biochemistry, Medical University of Sofia.'}, {'ForeName': 'Vanio I', 'Initials': 'VI', 'LastName': 'Mitev', 'Affiliation': 'Molecular Medicine Center, Department of Medical Chemistry and Biochemistry, Medical University of Sofia.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Batra', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Clements', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology.'}, {'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Spurdle', 'Affiliation': 'Molecular Cancer Epidemiology Laboratory, QIMR Berghofer Medical Research Institute.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Teixeira', 'Affiliation': 'Department of Genetics, Portuguese Oncology Institute, Porto, Portugal and Biomedical Sciences Institute (ICBAS).'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Paulo', 'Affiliation': 'Research Center (CI-IPOP), Portuguese Oncology Institute of Porto.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Maia', 'Affiliation': 'Department of Genetics, Portuguese Oncology Institute-Porto.'}, {'ForeName': 'Hardev', 'Initials': 'H', 'LastName': 'Pandha', 'Affiliation': 'Clinical and Experimental Medicine, University of Surrey.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Michael', 'Affiliation': 'Clinical and Experimental Medicine, University of Surrey.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Mills', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'Oslo University Hospital and University of Oslo.'}, {'ForeName': 'Anders M', 'Initials': 'AM', 'LastName': 'Dale', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Seibert', 'Affiliation': 'Radiation Medicine and Applied Sciences, University of California, San Diego tseibert@ucsd.edu.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1527'] 2762,32581121,Toward a science of delivering aid with dignity: Experimental evidence and local forecasts from Kenya.,"How can governments and nonprofits design aid programs that afford dignity and facilitate beneficial outcomes for recipients? We conceptualize dignity as a state that manifests when the stigma associated with receiving aid is countered and recipients are empowered, both in culturally resonant ways. Yet materials from the largest cash transfer programs in Africa predominantly characterize recipients as needy and vulnerable. Three studies examined the causal effects of alternative aid narratives on cash transfer recipients and donors. In study 1, residents of low-income settlements in Nairobi, Kenya ( N = 565) received cash-based aid accompanied by a randomly assigned narrative: the default deficit-focused ""Poverty Alleviation"" narrative, an ""Individual Empowerment"" narrative, or a ""Community Empowerment"" narrative. They then chose whether to spend time building business skills or watching leisure videos. Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma. Given the diverse settings in which aid is delivered, how can organizations quickly identify effective narratives in a context? We asked recipients to predict which narrative would best motivate skill-building in their community. In study 2, this ""local forecasting"" methodology outperformed participant evaluations and experimental pilots in accurately ranking treatments. Finally, study 3 confirmed that the narrative most effective for recipients did not undermine donors' willingness to contribute to the program. Together these studies show that responding to recipients' psychological and sociocultural realities in the design of aid can afford recipients dignity and help realize aid's potential.",2020,"Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma.","['residents of low-income settlements in Nairobi, Kenya ( N = 565) received']","['dignity', 'cash-based aid accompanied by a randomly assigned narrative: the default deficit-focused ""Poverty Alleviation"" narrative, an ""Individual Empowerment"" narrative, or a ""Community Empowerment"" narrative']",['self-efficacy and anticipated social mobility'],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0181758,"Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma.","[{'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305; ccthomas@stanford.edu hmarkus@stanford.edu.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Otis', 'Affiliation': 'Division of Health Policy and Management, University of California, Berkeley, CA 94720.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Abraham', 'Affiliation': 'Department of Economics, University of California, San Diego, CA 92161.'}, {'ForeName': 'Hazel Rose', 'Initials': 'HR', 'LastName': 'Markus', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305; ccthomas@stanford.edu hmarkus@stanford.edu.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Walton', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1917046117'] 2763,32581509,Tear Film Characteristics During Wear of Daily Disposable Contact Lenses.,"Purpose To evaluate changes induced over time by three daily disposable (DD) contact lenses on tear meniscus height (TMH), pre-lens non-invasive break-up time (pre-lens NIBUT), tear film osmolarity (TO) and objective quality of vision (OQV). Patients and Methods Forty-six subjects enrolled in this prospective open-label unmasked non-randomized simultaneous comparative cross-over study. For the first week of the study, subjects wore a nesofilcon A lens in the right eye and a delefilcon A lens in the left eye. After 3 days of washout, for the second week, subjects wore a nesofilcon A lens in the left eye and a stenfilcon A lens in the right eye. TMH, pre-lens NIBUT, TO and OQV were measured before contact lens fitting and for each contact lens combination on day 1 at 20 minutes and on day 7 after ≥8 hours of wear. OQV measurement included the changes of objective scatter index (OSI), the stability index (SI) and the fluctuation index (FI) calculated in a range of time of 20 s from a blink. Results TMH was unchanged at 20 minutes wear of all lenses but was significantly reduced after 8 or more hours wear (on day 7) of delefilcon A and stenfilcon A, respectively. Pre-lens NIBUT was significantly reduced with all lenses, while no significant change in TO was observed with any lens. SI and FI increased significantly for all lenses at both wear times. Conclusion While the presence of any contact lens on the eye challenges the tear film, nesofilcon A contact lenses, despite their high water content, compared to delefilcon A and stenfilcon A contact lenses, showed a lower overall effect. We speculate that superior tear film behavior while wearing nesofilcon A lenses may translate to improved subjective comfort, but this remains to be evaluated.",2020,"Results TMH was unchanged at 20 minutes wear of all lenses but was significantly reduced after 8 or more hours wear (on day 7) of delefilcon A and stenfilcon A, respectively.",['Patients and Methods\n\n\nForty-six subjects enrolled in this prospective open-label unmasked non-randomized simultaneous comparative cross-over study'],"['daily disposable (DD) contact lenses', 'superior tear film behavior while wearing nesofilcon']","['objective scatter index (OSI), the stability index (SI) and the fluctuation index (FI', 'Tear Film Characteristics', 'TO and OQV', 'SI and FI', 'tear meniscus height (TMH), pre-lens non-invasive break-up time (pre-lens NIBUT), tear film osmolarity (TO) and objective quality of vision (OQV', 'subjective comfort', 'TO', 'TMH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439742', 'cui_str': 'Scattered'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",46.0,0.023625,"Results TMH was unchanged at 20 minutes wear of all lenses but was significantly reduced after 8 or more hours wear (on day 7) of delefilcon A and stenfilcon A, respectively.","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Montani', 'Affiliation': 'Dipartimento di Matematica e Fisica ""Ennio De Giorgi"", CERCA Università del Salento, Lecce, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Martino', 'Affiliation': 'Dipartimento di Matematica e Fisica ""Ennio De Giorgi"", CERCA Università del Salento, Lecce, Italy.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S242422'] 2764,32581524,Erratum: The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies [Corrigendum].,[This corrects the article DOI: 10.2147/COPD.S242767.].,2020,[This corrects the article DOI: 10.2147/COPD.S242767.].,['Patients with COPD from the GOLDEN 3 and 4 Studies [Corrigendum'],['Nebulized Glycopyrrolate'],['Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0383834,[This corrects the article DOI: 10.2147/COPD.S242767.].,[],International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S262956'] 2765,32581540,The Effectiveness of Occupational Therapy-Based Sleep Interventions on Quality of Life and Fatigue in Patients with Multiple Sclerosis: A Pilot Randomized Clinical Trial Study.,"Purpose Sleep difficulties are common in patients with multiple sclerosis (MS), which may increase feelings of fatigue, negatively interfere with daily activities, and consequently reduce their quality of life. Studies examining the effects of sleep-targeted interventions in MS are currently limited in the literature. Therefore, we aim to assess the effects of occupational therapy interventions on sleep quality, fatigue, and quality of life in patients with MS. Patients and Methods In a single-blind, randomized, controlled trial, which occurred between April 2018 and March 2019 in Tehran, Iran, 20 eligible patients with MS were assessed using the Pittsburgh Sleep Quality Index (PSQI), Fatigue Impact Scale (FIS), Fatigue Severity Scale (FSS), and Short-Form Health Survey (SF-36). Patients were allocated randomly into the two following groups: patients receiving care-as-usual for MS (CAU) and patients receiving care-as-usual plus intervention (CAU + intervention). Both intervention groups underwent 2-3 sessions per week lasting 30-45 minutes for 8 weeks and received follow-up assessments. Data were analyzed using independent sample t-tests and Mann-Whitney U tests using SPSS (16 ver.) statistical software. Results In the intervention group, sleep quality improved significantly across all items ( p <0.001, effect size = 0.60) except for sleep efficiency and the use of sleep medications. FSS and FIS in the sleep intervention group were significantly reduced ( p <0.001, effect size = 0.76 and p <0.001, effect size = 0.82, respectively). The quality of life in the intervention group improved significantly ( p <0.004, effect size = 0.51-0.76) with the exception of the social functioning subgroup. Conclusion Although this is the result of a pilot study and more patients should be added, this intervention program demonstrates improvement in sleep quality and quality of life while decreasing fatigue in patients with MS. Adjunction of this program, if results are similar with more patients, to routine occupational therapy (OT) interventions can help improve the rehabilitation program of MS patients.",2020,"The quality of life in the intervention group improved significantly ( p <0.004, effect size = 0.51-0.76) with the exception of the social functioning subgroup. ","['patients with MS', 'patients with multiple sclerosis (MS', 'April 2018 and March 2019 in Tehran, Iran, 20 eligible patients with MS', 'Patients with Multiple Sclerosis']","['routine occupational therapy (OT) interventions', 'patients receiving care-as-usual for MS (CAU) and patients receiving care-as-usual plus intervention (CAU + intervention', 'occupational therapy interventions', 'Occupational Therapy-Based Sleep Interventions']","['quality of life', 'sleep efficiency and the use of sleep medications', 'Quality of Life and Fatigue', 'FSS and FIS', 'sleep quality, fatigue, and quality of life', 'Pittsburgh Sleep Quality Index (PSQI), Fatigue Impact Scale (FIS), Fatigue Severity Scale (FSS), and Short-Form Health Survey (SF-36', 'sleep quality and quality of life', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",20.0,0.0583345,"The quality of life in the intervention group improved significantly ( p <0.004, effect size = 0.51-0.76) with the exception of the social functioning subgroup. ","[{'ForeName': 'Malahat', 'Initials': 'M', 'LastName': 'Akbarfahimi', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation Sciences, Neuroscience Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Massood', 'Initials': 'SM', 'LastName': 'Nabavi', 'Affiliation': 'Regenerative Biomedicine Department, Cell Research Center, Royan Institute for Stem Cell Biology and Technology, ACCR, Tehran, Iran.'}, {'ForeName': 'Benyamin', 'Initials': 'B', 'LastName': 'Kor', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leeba', 'Initials': 'L', 'LastName': 'Rezaie', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Paschall', 'Affiliation': 'Clinical Psychology, Eastern Michigan University, Ypsilanti, Michigan, USA.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S249277'] 2766,32581587,Efficacy of Nivolumab for Head and Neck Cancer Patients with Primary Sites and Histological Subtypes Excluded from the CheckMate-141 Trial.,"Background In the CheckMate-141 trial, nivolumab conferred a survival benefit in patients with recurrent or metastatic refractory squamous cell carcinoma (SCC) head and neck cancer (HNC). Here, we examined the efficacy of nivolumab in patients with histological subtypes or primary sites of HNC not included in the CheckMate-141 trial. Methods This was a retrospective analysis of data collected prospectively from 97 patients who were treated with nivolumab for recurrent or metastatic HNC at our institution. The patients were assigned to three groups based on HNC primary site: 1) oral cavity, pharynx, and larynx, which were included in CheckMate-141 (n = 68), 2) nasopharynx (excluded in CheckMate-141, n = 7) and 3) other primary sites excluded in CheckMate-141 (n = 22) and assigned to two groups according to histological subtype: 1) SCC (included in CheckMate-141, n = 83) and 2) non-SCC (all sites excluded in CheckMate-141, n = 14). Survival outcomes and nivolumab treatment response were compared between the primary site and histological subgroups. Results The median number of nivolumab treatments was 7 cycles (range, 1-53 cycles) and the median follow-up time was 9.1 months (range, 0.66-33.0 months). There were no significant differences in response rates between the three primary site subgroups (CheckMate-141 sites 22%, nasopharynx 43%, others 18%; p=0) or the two histological subtype subgroups (SCC 25%, non-SCC 7%, p=0). Similarly, overall survival and progression-free survival were comparable for patients stratified by primary site or histological subtype. Conclusion No significant difference in response rates or survival outcomes was detected between nivolumab-treated HNC patients with primary sites and histological subtypes that were included versus excluded in the CheckMate-141 trial. These data provide a potential rationale for nivolumab therapy for all HNC patients in clinical practice.",2020,No significant difference in response rates or survival outcomes was detected between nivolumab-treated HNC patients with primary sites and histological subtypes that were included versus excluded in the CheckMate-141 trial.,"['n = 68), 2) nasopharynx (excluded in CheckMate-141, n = 7) and 3) other primary sites excluded in CheckMate-141 (n = 22) and assigned to two groups according to histological subtype: 1) SCC (included in CheckMate-141, n = 83) and 2) non-SCC (all sites excluded in CheckMate-141, n = 14', 'patients with histological subtypes or primary sites of HNC not included in the CheckMate-141 trial', '97 patients who were treated with nivolumab for recurrent or metastatic HNC at our institution', 'patients with recurrent or metastatic refractory squamous cell carcinoma (SCC) head and neck cancer (HNC', 'Head and Neck Cancer Patients with Primary Sites and Histological Subtypes Excluded from the CheckMate-141 Trial']","['oral cavity, pharynx, and larynx, which were included in CheckMate-141', 'nivolumab', 'Nivolumab']","['response rates or survival outcomes', 'Survival outcomes and nivolumab treatment response', 'survival benefit', 'response rates', 'median number of nivolumab treatments', 'overall survival and progression-free survival']","[{'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744619', 'cui_str': 'Head and neck cancer metastatic'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",97.0,0.0966141,No significant difference in response rates or survival outcomes was detected between nivolumab-treated HNC patients with primary sites and histological subtypes that were included versus excluded in the CheckMate-141 trial.,"[{'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Fukuda', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Urasaki', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Ohmoto', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nakano', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Yunokawa', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Pathology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Mitani', 'Affiliation': 'Head and Neck Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Tomomatsu', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.'}]",Cancer management and research,['10.2147/CMAR.S249393'] 2767,32586361,"Transmuscular quadratus lumborum (TQL) block for laparoscopic colorectal surgery: study protocol for a double-blind, prospective randomized placebo-controlled trial.","BACKGROUND Thoracic epidural anesthesia is no longer considered the gold standard for perioperative analgesia in laparoscopic colorectal procedures. In the search for alternatives, the efficacy of the transverse abdominal plane (TAP) block and other abdominal wall blocks such as the transmuscular quadratus lumborum (TQL) block continues to be investigated for postoperative pain management. Most of the initial studies on TAP blocks reported positive effects; however, the amount of studies with negative outcomes is increasing, most probably due to the fact that the majority of abdominal wall blocks fail to mitigate visceral pain. The TQL block could prove attractive in the search for better postoperative pain relief after laparoscopic colorectal surgery. In several cadaveric studies of the TQL, a spread of dye into the thoracic paravertebral space, the intercostal spaces, and even the thoracic sympathetic trunk was reported. Given the advantage of possibly reaching the thoracic paravertebral space, the potential to reach nerves transmitting visceral pain, and the possible coverage of dermatomes T4-L1, we hypothesize that the TQL provides superior postoperative analgesia for laparoscopic colorectal surgery as compared to patient-controlled intravenous analgesia with morphine alone. METHODS AND DESIGN In this prospective, randomized, double-blind controlled clinical trial, 150 patients undergoing laparoscopic colorectal surgery will be included. Patients will be randomly allocated to two different analgesic strategies: a bilateral TQL with 30 ml ropivacaine 0.375% each on both sides, administered before induction of anesthesia, plus postoperative patient-controlled intravenous analgesia with morphine (TQL group, n = 75), or a bilateral TQL block with 30 ml saline each on both sides plus postoperative patient-controlled intravenous analgesia with morphine (placebo group, n = 75). Our primary outcome parameter will be the morphine consumption during the first 24 h postsurgery. Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24 h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)). Epidural analgesia is no longer the standard of care for postoperative analgesia in laparoscopic colorectal surgery. Until now, the most effective analgesic strategy in these patients especially in an enhanced recovery program is still unknown. Several abdominal wall blocks (TAP, fascia transversalis plane block) are known to have an analgesic effect only on somatic pain. Recognizing the importance of procedure-specific pain management, we aim to investigate whether a transmuscular quadratus lumborum block delivers superior pain control in comparison to patient-controlled intravenous analgesia with morphine alone. TRIAL REGISTRATION EudraCT identifier 2019-002304-40. Registered on 17 September 2019.",2020,"Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24 h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)).","['150 patients undergoing', 'laparoscopic colorectal surgery', 'after laparoscopic colorectal surgery']","['transmuscular quadratus lumborum block', 'Epidural analgesia', 'laparoscopic colorectal surgery', 'Transmuscular quadratus lumborum (TQL) block', 'placebo', 'bilateral TQL with 30\u2009ml ropivacaine 0.375% each on both sides, administered before induction of anesthesia, plus postoperative patient-controlled intravenous analgesia with morphine (TQL group, n\u2009=\u200975), or a bilateral TQL block with 30\u2009ml saline each on both sides plus postoperative patient-controlled intravenous analgesia with morphine (placebo', 'TQL', 'morphine']","['total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels', 'local anesthetic systemic toxicity (LAST', 'pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24\u2009h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU', 'morphine consumption during the first 24\u2009h postsurgery', 'postoperative pain relief', 'incidence of adverse events']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4761262', 'cui_str': 'Local anaesthetic systemic toxicity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453855', 'cui_str': 'Solid food'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",150.0,0.231922,"Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24 h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)).","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Coppens', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium. Steve.coppens@uzleuven.be.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven-University of Leuven & Universiteit Hasselt, Kapucijnenvoer 35, B-3000, Leuven, Belgium.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Neyrinck', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': ""D'Hoore"", 'Affiliation': 'Department of Abdominal Surgery, KU Leuven-University Hospitals of Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Geertrui', 'Initials': 'G', 'LastName': 'Dewinter', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}]",Trials,['10.1186/s13063-020-04525-6'] 2768,32586362,"Evaluation of the SPIRIT Integrated Suicide Prevention Programme: study protocol for a cluster-randomised controlled trial in rural Gujarat, India.","BACKGROUND Suicide is a major public health challenge globally and specifically in India where 36.6% and 24.3% of all suicides worldwide occur in women and men, respectively. The United Nations Sustainable Development Goals uses suicide rate as one of two indicators for Target 3.4, aimed at reducing these deaths by one third by 2030. India has no examples of large-scale implementation of evidence-based interventions to prevent suicide; however, there is a sizeable evidence base to draw on for suicide prevention strategies that have been piloted in India or proven to be effective regionally or internationally. METHOD The SPIRIT study is designed as a cluster-randomized superiority trial and uses mixed methods to evaluate the implementation, effectiveness and costs of an integrated suicide prevention programme consisting of three integrated interventions including (1) a secondary-school-based intervention to reduce suicidal ideation among adolescents, (2) a community storage facility intervention to reduce access to pesticides and (3) training for community health workers in recognition, management, and appropriate referral of people identified with high suicidal risk. DISCUSSION Combining three evidence-based interventions that tackle suicide among high-risk groups may generate a synergistic impact in reducing suicides at the community level in rural areas in India. Examination of implementation processes throughout the trial will also help to prepare a roadmap for policymakers and researchers looking to implement suicide prevention interventions in other countries and at scale. TRIAL REGISTRATION Clinical Trial Registry of Indian Council of Medical Research, India: CTRI/2017/04/008313. Registered on 7 April 2017. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18256&EncHid=&userName=SPIRIT Trial registry was last modified on 28 June 2019.",2020,Combining three evidence-based interventions that tackle suicide among high-risk groups may generate a synergistic impact in reducing suicides at the community level in rural areas in India.,"['community health workers in recognition, management, and appropriate referral of people identified with high suicidal risk', 'rural Gujarat, India']","['community storage facility intervention to reduce access to pesticides and (3) training', 'integrated suicide prevention programme consisting of three integrated interventions including (1) a secondary-school-based intervention']",[],"[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031253', 'cui_str': 'Pesticide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.166794,Combining three evidence-based interventions that tackle suicide among high-risk groups may generate a synergistic impact in reducing suicides at the community level in rural areas in India.,"[{'ForeName': 'Soumitra', 'Initials': 'S', 'LastName': 'Pathare', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India. spathare@cmhlp.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Shields-Zeeman', 'Affiliation': 'Netherlands Institute for Mental health and Addiction (Trimbos Institute), Da Costakade 45, Utrecht, 3521 VT, the Netherlands.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Vijayakumar', 'Affiliation': 'SNEHA Suicide Prevention Centre, Chennai, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Pandit', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Nardodkar', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'George Institute for Global Health Elegance Tower, 311-312, Third Floor, JasolaVihar, New Delhi, 110025, India.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Kalha', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Sadhvi', 'Initials': 'S', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shahjahan', 'Affiliation': 'Bangladesh Centre for Communication Programs, Dhaka, Bangladesh.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': 'Hospital for Mental Health, Ahmedabad, India.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Netherlands Institute for Mental health and Addiction (Trimbos Institute), Da Costakade 45, Utrecht, 3521 VT, the Netherlands.'}]",Trials,['10.1186/s13063-020-04472-2'] 2769,32586363,Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES In this study, we investigate the effect of hydroxychloroquine on the prevention of Novel Coronavirus Disease (COVID-19) in cancer patients being treated. TRIAL DESIGN This is a multi-centre, two-arm, parallel-group, triple-blind, phase 2-3 randomised controlled trial. PARTICIPANTS All patients over the age of 15 from 5 types of cancer are included in the study. Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin's lymphoma treated with leukemia protocols and patients with non-metastatic breast and colon cancer in the first line of treatment will enter the study. The exclusion criteria will include known sensitivity to Hydroxychloroquine, weight below 35 kilograms, history of retinopathy, history of any cardiac disease, acute respiratory tract infection in the last 2 months, having COVID-19 in the first two weeks of entering the trial, having Diabetes Mellitus, having an immuno-suppressive disease other than cancer, having chronic pulmonary disease and taking immuno-suppressant drug other than chemotherapeutic agents for current cancer. This study is performed in five academic centres affiliated to Mashhad University of Medical Sciences, Mashhad, Iran. INTERVENTION AND COMPARATOR Patients are randomly assigned to two groups; one being given hydroxychloroquine and the other is given placebo. During two months of treatment, the two groups are treated with either hydroxychloroquine (Amin® Pharmaceutical Company, Isfahan, Iran) or placebo (identical in terms of shape, colour, smell) as a single 200 mg tablet every other day. Patients will be monitored for COVID-19 symptoms during the follow-up period. If signs or symptoms occur (fever, cough, shortness of breath), they will be examined and investigated with a high-resolution computed tomography (CT) scan of the lungs, COVID-19 specific IgM, IgG antibody assay and a nucleic acid amplification test (NAT) for the SARS-CoV-2 virus. MAIN OUTCOMES The primary end point of this study is to investigate the incidence of COVID-19 in patients being treated for their cancer over a 2-month period. RANDOMISATION Randomisation will be performed using randomly permuted blocks. By using an online website (www.randomization.com) the randomization sequence will be produced by quadruple blocks. The allocation ratio in intervention and control groups is 1:1. BLINDING (MASKING) Participants and caregivers do not know whether the patient is in the intervention or the control group. The outcome assessor and the data analyst are also blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The calculated total sample size is 60 patients, with 30 patients in each group. TRIAL STATUS The trial began on April 14, 2020 and recruitment is ongoing. Recruitment is anticipated to be completed by June 14, 2020 There has been no change in study protocol since approval, protocol version 1 was approved April 12, 2020. TRIAL REGISTRATION This trial has been registered by the title of ""Effect of Hydroxychloroquine on Novel Coronavirus Disease (COVID-19) prevention in cancer patients under treatment"" in Iranian Registry of Clinical Trials (IRCT) with code ""IRCT20200405046958N1"", https://www.irct.ir/trial/46946. Registration date is April 14, 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Recruitment is anticipated to be completed by June 14, 2020 There has been no change in study protocol since approval, protocol version 1 was approved April 12, 2020. ","['cancer patients', 'five academic centres affiliated to Mashhad University of Medical Sciences, Mashhad, Iran', 'All patients over the age of 15 from 5 types of cancer are included in the study', 'cancer patients being treated', ""Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin's lymphoma treated with leukemia protocols and patients with non-metastatic breast and colon cancer"", '60 patients, with 30 patients in each group', 'cancer patients undergoing treatment', 'patients being treated for their cancer over a 2-month period']","['placebo', 'Hydroxychloroquine', 'hydroxychloroquine (Amin® Pharmaceutical Company, Isfahan, Iran) or placebo', 'hydroxychloroquine']","['incidence of COVID-19', 'signs or symptoms occur (fever, cough, shortness of breath']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023470', 'cui_str': 'Myeloid leukemia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.193621,"Recruitment is anticipated to be completed by June 14, 2020 There has been no change in study protocol since approval, protocol version 1 was approved April 12, 2020. ","[{'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Allahyari', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rahimi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Khadem-Rezaiyan', 'Affiliation': 'Community Medicine, Clinical Research Development Unit, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mozaheb', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Seddigh-Shamsi', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Bary', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Kamandi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sajad Ataei', 'Initials': 'SA', 'LastName': 'Azimi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeed Eslami', 'Initials': 'SE', 'LastName': 'HasanAbadi', 'Affiliation': 'Medical Informatics, Pharmacy School, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Noferesti', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Somayeh Sadat', 'Initials': 'SS', 'LastName': 'Shariatmaghani', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Houshang', 'Initials': 'H', 'LastName': 'Rafatpanah', 'Affiliation': 'Immunology, Immunology Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Khatami', 'Affiliation': 'Internal Medicine, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Afshin Jabbar', 'Initials': 'AJ', 'LastName': 'Imani', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mortazi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Moeini', 'Initials': 'MM', 'LastName': 'Nodeh', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. moeininm@mums.ac.ir.'}]",Trials,['10.1186/s13063-020-04485-x'] 2770,32586366,Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial.,"BACKGROUND Pathological skin scars, caused by cesarean section, affected younger mothers esthetically and psychosocially and to some extent frustrated obstetricians and dermatologists. Umbilical cord mesenchymal stem cells (UC-MSCs), as a population of multipotent cells, are abundant in human tissues, providing several possibilities for their effects on skin scar tissues. Herein, we performed a randomized, double-blind, placebo-controlled, three-arm clinical trial, aiming to assess the efficacy and safety of UC-MSCs in the treatment of cesarean section skin scars among primiparous singleton pregnant women. METHODS Ninety primiparous singleton pregnant women undergoing elective cesarean section were randomly allocated to receive placebo, low-dose (3 × 10 6 cells), or high-dose (6 × 10 6 cells) transdermal hydrogel UC-MSCs on the surface of the skin incision. The primary outcome was cesarean section skin scars followed after the sixth month, assessed by the Vancouver Scar Scale (VSS). RESULTS All the participants completed their trial of the primary outcome according to the protocol. The mean score of estimated total VSS was 5.52 in all participants at the sixth-month follow-up, with 6.43 in the placebo group, 5.18 in the low-dose group, and 4.71 in the high-dose group, respectively. No significant difference was found between-group in the mean scores for VSS at the sixth month. Additional prespecified secondary outcomes were not found with significant differences among groups either. No obvious side effects or adverse effects were reported in any of the three arms. CONCLUSION This randomized clinical trial showed that UC-MSCs did not demonstrate the effects of improvement of cesarean section skin scars. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT02772289. Registered on 13 May 2016.",2020,"No obvious side effects or adverse effects were reported in any of the three arms. ","['primiparous singleton pregnant women', 'Ninety primiparous singleton pregnant women undergoing elective cesarean section', 'cesarean section skin scars']","['UC-MSCs', 'placebo, low-dose (3\u2009×\u200910 6 cells), or high-dose (6\u2009×\u200910 6 cells) transdermal hydrogel UC-MSCs', 'umbilical cord mesenchymal stem cells', 'Umbilical cord mesenchymal stem cells (UC-MSCs', 'placebo']","['cesarean section skin scars', 'Efficacy and safety', 'efficacy and safety', 'Vancouver Scar Scale (VSS', 'mean score of estimated total VSS', 'adverse effects']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.521774,"No obvious side effects or adverse effects were reported in any of the three arms. ","[{'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Obstetrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Anhui Medical University, Hefei, 230032, Anhui, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Shaoxin', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Dongxin', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Huiting', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Experimental Hematology, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, 300020, China. hanzhongchao@hotmail.com.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China. fsguoxl@163.com.'}, {'ForeName': 'Zhengping', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China. liuzphlk81@outlook.com.'}]",Stem cell research & therapy,['10.1186/s13287-020-01695-7'] 2771,32586393,The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer.,"BACKGROUND Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential to guide treatment selection and prolong PFS. We designed a platform trial to test this hypothesis. METHODS The Prostate-Biomarker (ProBio) study is a multi-center, outcome-adaptive, multi-arm, biomarker-driven platform trial for tailoring treatment decisions for men with mCRPC. Treatment decisions in the experimental arms are based on biomarker signatures defined as mutations in certain genes/pathways suggested in the scientific literature to be important for treatment response in mCRPC. The biomarker signatures are determined by targeted sequencing of circulating tumor and germline DNA using a panel specifically designed for mCRPC. DISCUSSION Patients are stratified based on the sequencing results and randomized to either current clinical practice (control), where the treating physician decides treatment, or to molecularly driven treatment selection based on the biomarker profile. Outcome-adaptive randomization is implemented to early identify promising treatments for a biomarker signature. Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm. Graduated combinations are further evaluated in a seamless confirmatory trial with fixed randomization. The platform design allows for new drugs and biomarkers to be introduced in the study. CONCLUSIONS The ProBio design allows promising treatment-biomarker combinations to quickly graduate from the platform and be confirmed for rapid implementation in clinical care. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03903835. Date of registration: April 4, 2019. Status: Recruiting.",2020,Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm.,"['patients with metastatic castration-resistant prostate cancer', 'patients with metastatic castration-resistant prostate cancer (mCRPC', 'Status', 'men with mCRPC']",[],['progression-free survival (PFS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0621446,Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm.,"[{'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Crippa', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. alessio.crippa@ki.se.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'De Laere', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Discacciati', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Gabriel', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Thellenberg', 'Affiliation': 'Department of Radiation Sciences and Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Jänes', 'Affiliation': 'Länssjukhuset Sundsvall Härnösand, Sundsvall, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Enblad', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala Universitet, Uppsala, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ullen', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hjälm-Eriksson', 'Affiliation': 'Capio St. Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oldenburg', 'Affiliation': 'Division of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Ost', 'Affiliation': 'Department of Radiotherapy and Experimental Cancer Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lindberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eklund', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Grönberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}]",Trials,['10.1186/s13063-020-04515-8'] 2772,32586400,"Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).","BACKGROUND Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival and the effect of out-of-school-hours teaching on children's literacy and numeracy in rural Madhya Pradesh. METHODS/DESIGN This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The clusters are 196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention. The participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation. The participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020. DISCUSSION In CHAMPION2, the NICE Foundation will deliver a 3.5-year programme comprising Accredited Social Health Activists or village health workers and midwives promoting health knowledge and providing antenatal, postnatal, and neonatal healthcare; community mobilisation; referrals to appropriate government health facilities; and a health education campaign. In STRIPES2, the Pratham Education Foundation will deliver a programme of village-based, before/after school support focusing on literacy and numeracy. As controls, the CHAMPION2 control villages will receive the usual health services (plus the STRIPES2 intervention). STRIPES2 control villages will receive the usual education services (plus the CHAMPION2 intervention). The primary outcome in CHAMPION2 is neonatal mortality. Secondary outcomes include antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness. The primary outcome in STRIPES2 is a composite literacy and numeracy test score. Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness. Independent research and implementation teams will conduct the trial. Trial Steering and Data Monitoring Committees, with independent members, will supervise the trial. TRIAL REGISTRATION Clinical Trial Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.",2020,"Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness.","['participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation', 'participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020', '196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention', ""children's literacy and numeracy in rural Madhya Pradesh""]","['villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention', 'school-hours teaching', 'complex package of health interventions']","[""separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness"", 'composite literacy and numeracy test score', 'neonatal survival', 'antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness', 'neonatal mortality']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",,0.117173,"Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness.","[{'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Rukmini', 'Initials': 'R', 'LastName': 'Banerji', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boone', 'Affiliation': 'Effective Intervention, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ila', 'Initials': 'I', 'LastName': 'Fazzio', 'Affiliation': 'Effective Intervention, London, UK. if@effint.org.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frost', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Gopal', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Karnati', 'Affiliation': 'GH Training and Consulting, Hyderabad, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Harshavardhan', 'Initials': 'H', 'LastName': 'Reddy', 'Affiliation': 'GH Training and Consulting, Hyderabad, India.'}, {'ForeName': 'Padmanabh', 'Initials': 'P', 'LastName': 'Reddy', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Dropti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Sajjan Singh', 'Initials': 'SS', 'LastName': 'Shekhawat', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Siddharudha', 'Initials': 'S', 'LastName': 'Shivalli', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}]",Trials,['10.1186/s13063-020-04339-6'] 2773,32586427,Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel.,"Cognitive behavioral therapy for insomnia (CBTi) is well established as the first-line treatment for the management of chronic insomnia. Identifying predictors of response to CBTi should enable the field to efficiently utilize resources to treat those who are likely to respond and to personalize treatment approaches to optimize outcomes for those who are less likely to respond to traditional CBTi. Although a range of studies have been conducted, no clear pattern of predictors of response to CBTi has emerged. The purpose of this study was to examine the impact and relative importance of a comprehensive group of pretreatment predictors of insomnia outcomes in 99 active-duty service members who received in-person CBTi in a randomized clinical trial. Results indicated that higher levels of baseline insomnia severity and total sleep time predicted greater improvements on the Insomnia Severity Index (ISI) following treatment. Higher depression symptoms and a history of head injury predicted a worse response to treatment (i.e., smaller improvements on the ISI). Clinically meaningful improvements, as measured by the reliable change index (RCI), were found in 59% of the sample. Over and above baseline insomnia severity, only depressive symptoms predicted this outcome. Future studies should examine if modifications to CBTi based on these predictors of response can improve outcomes.",2020,"Clinically meaningful improvements, as measured by the reliable change index (RCI), were found in 59% of the sample.","['99 active-duty service members who received in-person CBTi in a randomized clinical trial', 'Insomnia (CBTi']","['Cognitive behavioral therapy', 'Cognitive Behavioral Therapy']","['baseline insomnia severity and total sleep time', 'Insomnia Severity Index (ISI', 'reliable change index (RCI', 'insomnia outcomes', 'Higher depression symptoms']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0313955,"Clinically meaningful improvements, as measured by the reliable change index (RCI), were found in 59% of the sample.","[{'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'University of Texas Health Science Center at San Antonio. Electronic address: pruiksma@uthscsa.edu.'}, {'ForeName': 'Willie J', 'Initials': 'WJ', 'LastName': 'Hale', 'Affiliation': 'University of Texas Health Science Center at San Antonio; University of Texas at San Antonio.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio; South Texas Veterans Health Care System, San Antonio; University of Texas at San Antonio.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wilkerson', 'Affiliation': 'Medical University of South Carolina.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nicholson', 'Affiliation': 'Carl R. Darnall Army Medical Center, Fort Hood, TX.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Fina', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Borah', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'VA Boston Healthcare System; Boston University.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT; University of Utah.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'University of Arizona.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Behavior therapy,['10.1016/j.beth.2020.02.001'] 2774,32586428,Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans.,"The goal of this study was to compare a brief behavioral treatment for insomnia (BBTI), which has fewer sessions (4), shorter duration (<30-45 minutes), and delivers treatment in-person plus phone calls to cognitive behavioral therapy for insomnia (CBTI), which has 5 in-person sessions. The hypothesis was BBTI would be noninferior to CBTI. The Reliable Change Index was used to establish a noninferiority margin (NIM) of 3.43, representing the maximum allowable difference between groups on the pre-post Insomnia Severity Index change (ΔISI). Sixty-three veterans with chronic insomnia were randomized to either BBTI or CBTI and veterans in both groups had significant reductions of their insomnia severity per the ISI and improved their sleep onset latency, total wake time, sleep efficiency, and sleep quality per sleep diaries. While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM. However, the 95% confidence interval of the between group pre-post ΔISI extended beyond the NIM, and thus BBTI was inconclusively noninferior to CBTI. Limitations, such as small sample size and high rate of dropout, indicate further study is needed to compare brief, alternative yet complementary behavioral insomnia interventions to CBTI. Still, evidence-based brief and flexible treatment options will help to further enhance access to care for veterans with chronic insomnia, especially in non-mental-health settings like primary care.",2020,"While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM.","['Insomnia', 'Veterans', 'Sixty-three veterans with chronic insomnia', 'veterans with chronic insomnia']","['Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy', 'BBTI or CBTI']","['Insomnia Severity Index change (ΔISI', 'insomnia severity per the ISI and improved their sleep onset latency, total wake time, sleep efficiency, and sleep quality per sleep diaries']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",,0.0360929,"While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM.","[{'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Bramoweth', 'Affiliation': 'VA Pittsburgh Healthcare System. Electronic address: Adam.Bramoweth@va.gov.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Lederer', 'Affiliation': 'VA Pittsburgh Healthcare System.'}, {'ForeName': 'Ada O', 'Initials': 'AO', 'LastName': 'Youk', 'Affiliation': 'VA Pittsburgh Healthcare System; University of Pittsburgh.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'University of Pittsburgh School of Medicine.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Chinman', 'Affiliation': 'VA Pittsburgh Healthcare System; RAND Corporation.'}]",Behavior therapy,['10.1016/j.beth.2020.02.002'] 2775,32586429,Effectiveness of an mHealth Intervention for Infant Sleep Disturbances.,"Bedtime problems and night wakings are highly prevalent in infants. This study assessed the real-world effectiveness of an mHealth behavioral sleep intervention (Customized Sleep Profile; CSP). Caregivers (83.9% mothers) of 404 infants (age 6 to 11.9 m, M = 8.32 m, 51.2% male) used the CSP (free and publicly available behavioral sleep intervention delivered via smartphone application, Johnson's® Bedtime® Baby Sleep App). Caregivers completed the Brief Infant Sleep Questionnaire-Revised (BISQ-R) at baseline and again 4 to 28 days later. Changes in sleep patterns were analyzed, based on sleep problem status (problem versus no problem sleepers; PS; NPS). Sleep onset latency improved in both groups. Earlier bedtimes, longer continuous stretches of sleep, as well as decreased number and duration of night wakings, were evident in the PS group only. The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group. Further, caregivers of infants in the PS group decreased feeding (bedtime and overnight) and picking up overnight, and perceived better sleep. Bedtime routine regularity, bedtime difficulty, sleep onset difficulty, and caregiver confidence improved for both groups, with the PS group showing a greater magnitude of change. Thus, a real-world, publicly available, mHealth behavioral sleep intervention was associated with improved outcomes for older infants. Intervention recommendations resulted in changes in caregivers' behavior and improvements in caregiver-reported sleep outcomes in infants, in as few as 4 days.",2020,"The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group.","['Caregivers (83.9% mothers) of 404 infants (age 6 to 11.9 m', 'Infant Sleep Disturbances', 'older infants']","['mHealth behavioral sleep intervention (Customized Sleep Profile; CSP', ""CSP (free and publicly available behavioral sleep intervention delivered via smartphone application, Johnson's® Bedtime® Baby Sleep App"", 'mHealth Intervention']","[""caregivers' behavior and improvements in caregiver-reported sleep outcomes"", 'Bedtime routine regularity, bedtime difficulty, sleep onset difficulty, and caregiver confidence', 'BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time', 'feeding (bedtime and overnight) and picking up overnight, and perceived better sleep', 'number and duration of night wakings', 'Bedtime problems and night wakings', 'Brief Infant Sleep Questionnaire-Revised (BISQ-R', 'Sleep onset latency']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010701', 'cui_str': 'Phyllodes tumour'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",404.0,0.0378914,"The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group.","[{'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Leichman', 'Affiliation': ""Saint Joseph's University. Electronic address: erin.leichman@sju.edu.""}, {'ForeName': 'Russell A', 'Initials': 'RA', 'LastName': 'Gould', 'Affiliation': 'Johnson & Johnson Consumer Inc.'}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Williamson', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'Russel M', 'Initials': 'RM', 'LastName': 'Walters', 'Affiliation': 'Johnson & Johnson Consumer Inc.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Mindell', 'Affiliation': ""Saint Joseph's University; Children's Hospital of Philadelphia.""}]",Behavior therapy,['10.1016/j.beth.2019.12.011'] 2776,32586433,Group Intervention for Adolescent Anxiety and Depression: Outcomes of a Randomized Trial with Adolescents in Kenya.,"Youth mental health interventions in low-resource communities may benefit from including empirically supported elements, using stigma-free content, and using trained lay-providers. We developed and evaluated such an intervention, targeting adolescent depression and anxiety in Kenya, where mental health care is limited by social stigma and a paucity of providers. Kenyan adolescents (N = 51, ages 14-17, 60.78% female) from a school in an urban slum in Nairobi with self-reported moderate-to-severe symptoms of depression or anxiety were randomized to the 4-week ""Shamiri"" (""thrive"") group intervention or a study skills control intervention of equal duration. The Shamiri intervention included growth mindset, gratitude, and value affirmation exercises. The content was delivered by recent high school graduates (ages 17-21, 60% male) trained as lay-providers. Participants met in school once-a-week in groups of 9-12 youths (average group size 10). Compared to the study-skills control, Shamiri produced greater reductions in adolescent depression symptoms (p = .038; d = .32) and anxiety symptoms (p = .039; d = .54) from baseline to 4-week follow-up, and greater improvements in academic performance (p = .034; d = .32) from the school-term before versus after the intervention. There were no effects on overall social support or perceived control, but the Shamiri group showed larger increases in perceived social support from friends (p = .028, d = .71). This appears to be the first report that a brief, lay-provider delivered, community-based intervention may reduce internalizing symptoms and improve academic outcomes in high-symptom adolescents in Sub-Saharan Africa. Larger replications with extended follow-ups will help gauge the strength and durability of these effects.",2020,"Compared to the study-skills control, Shamiri produced greater reductions in adolescent depression symptoms (p = .038; d = .32) and anxiety symptoms (p = .039; d = .54) from baseline to 4-week follow-up, and greater improvements in academic performance (p = .034; d = .32) from the school-term before versus after the intervention.","['Participants met in school once-a-week in groups of 9-12 youths (average group size 10', 'Adolescents in Kenya', 'high-symptom adolescents in Sub-Saharan Africa', 'Kenyan adolescents (N\u202f=\u202f51, ages 14-17, 60.78% female) from a school in an urban slum in Nairobi with self-reported moderate-to-severe symptoms of depression or anxiety']","['4-week ""Shamiri"" (""thrive"") group intervention or a study skills control intervention of equal duration']","['anxiety symptoms', 'growth mindset, gratitude, and value affirmation exercises', 'overall social support', 'adolescent depression symptoms', 'academic performance', 'perceived social support']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0333652,"Compared to the study-skills control, Shamiri produced greater reductions in adolescent depression symptoms (p = .038; d = .32) and anxiety symptoms (p = .039; d = .54) from baseline to 4-week follow-up, and greater improvements in academic performance (p = .034; d = .32) from the school-term before versus after the intervention.","[{'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Osborn', 'Affiliation': 'Harvard University; Shamiri Institute, Pittsfield, MA. Electronic address: osborn@shamiri.institute.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Harvard University; University of Pennsylvania.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Harvard University; Shamiri Institute, Pittsfield, MA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'Stony Brook University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Harvard University.'}]",Behavior therapy,['10.1016/j.beth.2019.09.005'] 2777,32586434,"Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Results From a Pilot Randomized Controlled Trial.","Be a Mom is a self-guided web-based intervention, grounded in cognitive behavioral therapy, delivered to postpartum women to prevent persistent postpartum depression [PPD] symptoms. We aimed to evaluate Be a Mom in terms of its preliminary efficacy, feasibility, and acceptability. A pilot randomized, two-arm controlled trial was conducted. Eligible women (presenting PPD risk-factors and/or early-onset PPD symptoms) were enrolled in the study and were randomly assigned to the intervention (Be a Mom) or to the waiting-list control group. Participants in both groups completed baseline (T1) and postintervention (T2) assessments. The 194 women presenting risk factors/early-onset PPD symptoms were allocated to the intervention (n = 98) or to the control (n = 96) group. A significant Time × Group interaction effect was found for both depressive and anxiety symptoms, with women in the intervention group presenting a larger decrease in symptoms from T1 to T2 (p < .05). Less than half of the women (41.8%) completed Be a Mom. Most women (71.4%) would use Be a Mom again if needed. Results provide preliminary evidence of the Be a Mom's efficacy, acceptability and feasibility, although further research is needed to establish Be a Mom as a selective/indicative preventive intervention for persistent PPD.",2020,"A significant Time × Group interaction effect was found for both depressive and anxiety symptoms, with women in the intervention group presenting a larger decrease in symptoms from T1 to T2 (p < .05).","['Eligible women (presenting PPD risk-factors and/or early-onset PPD symptoms', '194 women presenting risk factors/early-onset PPD symptoms']",['waiting-list control group'],['depressive and anxiety symptoms'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",194.0,0.154431,"A significant Time × Group interaction effect was found for both depressive and anxiety symptoms, with women in the intervention group presenting a larger decrease in symptoms from T1 to T2 (p < .05).","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra. Electronic address: anadfonseca@fpce.uc.pt.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Alves', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Monteiro', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gorayeb', 'Affiliation': 'University of São Paulo.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Canavarro', 'Affiliation': 'CINEICC - Center for Research in Neuropsychology and Cognitive-Behavioral Intervention, University of Coimbra.'}]",Behavior therapy,['10.1016/j.beth.2019.09.007'] 2778,32586526,Variants in ADRB1 and CYP2C9: Association with Response to Atenolol and Losartan in Marfan Syndrome.,"OBJECTIVE To test whether variants in ADRB1 and CYP2C9 genes identify subgroups of individuals with differential response to treatment for Marfan syndrome through analysis of data from a large, randomized trial. STUDY DESIGN In a subset of 250 white, non-Hispanic participants with Marfan syndrome in a prior randomized trial of atenolol vs losartan, the common variants rs1801252 and rs1801253 in ADRB1 and rs1799853 and rs1057910 in CYP2C9 were analyzed. The primary outcome was baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3 years, assessed using mixed effects models. RESULTS Among 122 atenolol-assigned participants, the 70 with rs1801253 CC genotype had greater rate of improvement in aortic root z-score compared with 52 participants with CG or GG genotypes (Time × Genotype interaction P = .005, mean annual z-score change ± SE -0.20 ± 0.03 vs -0.09 ± 0.03). Among participants with the CC genotype in both treatment arms, those assigned to atenolol had greater rate of improvement compared with the 71 of the 121 assigned to losartan (interaction P = .002; -0.20 ± 0.02 vs -0.07 ± 0.02; P < .001). There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status. CONCLUSIONS In this exploratory study, ADRB1-rs1801253 was associated with atenolol response in children and young adults with Marfan syndrome. If these findings are confirmed in future studies, ADRB1 genotyping has the potential to guide therapy by identifying those who are likely to have greater therapeutic response to atenolol than losartan.",2020,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status. ","['250 white, non-Hispanic participants with Marfan syndrome', 'Marfan Syndrome', 'children and young adults with Marfan syndrome']","['atenolol vs losartan', 'losartan', 'Atenolol and Losartan', 'atenolol']","['atenolol response', 'rate of improvement in aortic root z-score', 'rate of improvement', 'baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3\xa0years, assessed using mixed effects models']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",52.0,0.139844,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status. ","[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Gelb', 'Affiliation': 'Mindich Child Health and Development Institute, Departments of Pediatrics and Genetics & Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shaine A', 'Initials': 'SA', 'LastName': 'Morris', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Dietz', 'Affiliation': 'Institute of Genetic Medicine, Johns Hopkins University School of Medicine and Howard Hughes Medical Institute, Baltimore, MD.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Forbus', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': ""Division of Cardiology, Children's Hospital of Philadelphia, Department of Pediatrics University of Pennsylvania Perlman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Hoskoppal', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Utah and Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'James', 'Affiliation': ""Department of Pediatrics, Section of Cardiology, Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Levine', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Loeys', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Josephina A N', 'Initials': 'JAN', 'LastName': 'Meester', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mital', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mosley', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Olson', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Renard', 'Affiliation': 'Center for Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Shaffer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sharkey', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, MO.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Departments of Pharmacology and Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.064'] 2779,32586583,Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial.,"BACKGROUND The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest. OBJECTIVES The purpose of this study was to assess recurrence of AF in the CABANA trial. METHODS The authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post-90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach. RESULTS Median age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p < 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p < 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p < 0.001). These findings were not sensitive to the baseline pattern of AF. CONCLUSIONS Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).",2020,"CONCLUSIONS Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up.","['2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy', 'Median age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0']","['Catheter ablation', 'CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy']","['recurrence of any symptomatic or asymptomatic AF', 'death, disabling stroke, serious bleeding, or cardiac arrest', 'recurrence of any AF', 'Recurrence of Atrial Fibrillation', 'Baseline Holter AF burden', 'AF burden', 'recurrence of AF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2204.0,0.155089,"CONCLUSIONS Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up.","[{'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle, Washington. Electronic address: jpoole@u.washington.edu.'}, {'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Johnson', 'Affiliation': 'Seattle Institute of Cardiac Research, Seattle, Washington.'}, {'ForeName': 'Hoss', 'Initials': 'H', 'LastName': 'Rostami', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Silverstein', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.04.065'] 2780,32586585,Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.,"BACKGROUND Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA 2 DS 2 -VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS A high-risk patient cohort (CHA 2 DS 2 -VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).",2020,"In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%).","['High-Risk Patients With Atrial Fibrillation', 'high-risk patients with AF', 'Atrial Fibrillation', 'Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA 2 DS 2 -VASc of\xa0≥3 and HAS-BLED of >2']","['LAAC or DOAC', 'direct oral anticoagulants (DOACs', 'LAAC', 'DOAC', 'apixaban', 'Direct Oral Anticoagulants', 'vitamin K antagonists (VKAs', 'Left Atrial Appendage Closure', 'Percutaneous left atrial appendage closure (LAAC']","['Major LAAC-related complications', 'stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications', 'modified intention to treat', 'cardiovascular death', 'risk of bleeding, LAAC']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}]",,0.287867,"In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%).","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Osmancik', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: pavel.osmancik@gmail.com.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Herman', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Neuzil', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hala', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Taborsky', 'Affiliation': 'Cardiocenter, Department of Cardiology, University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Poloczek', 'Affiliation': 'Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stasek', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Haman', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Branny', 'Affiliation': 'Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Chovancik', 'Affiliation': 'Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Cervinka', 'Affiliation': 'Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and J.E.Purkyne University, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Holy', 'Affiliation': 'Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and J.E.Purkyne University, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kovarnik', 'Affiliation': 'Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zemanek', 'Affiliation': 'Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.'}, {'ForeName': 'Stepan', 'Initials': 'S', 'LastName': 'Havranek', 'Affiliation': 'Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.'}, {'ForeName': 'Vlastimil', 'Initials': 'V', 'LastName': 'Vancura', 'Affiliation': 'Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Opatrny', 'Affiliation': 'Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Peichl', 'Affiliation': 'Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Tousek', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Lekesova', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Jarkovsky', 'Affiliation': 'Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Novackova', 'Affiliation': 'Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Benesova', 'Affiliation': 'Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimsky', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic; Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: vivek.reddy@mountsinai.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.04.067'] 2781,32586587,Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.,"BACKGROUND Hospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown. OBJECTIVES The purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge. METHODS MARINER (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE). Medically ill patients with a baseline creatinine clearance ≥50 ml/min were randomized in a double-blind fashion to rivaroxaban 10 mg or placebo daily at hospital discharge for 45 days. Exploratory efficacy analyses were performed with the intent-to-treat population including all data through day 45. Time-to-event curves were calculated using the Kaplan-Meier method. A blinded independent committee adjudicated all clinical events. RESULTS In total, 4,909 patients were assigned to rivaroxaban and 4,913 patients to placebo. The mean age was 67.8 years, 55.5% were men, mean baseline creatinine clearance was 87.8 ml/min, and mean duration of hospitalization was 6.7 days. The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). CONCLUSIONS Extended-duration rivaroxaban in hospitalized medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding. (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients [MARINER]; NCT02111564).",2020,"The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). ","['Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE', 'acutely ill medical patients after discharge', '4,909 patients', 'Medically\xa0Ill\xa0Patients', 'Hospitalized acutely ill medical patients', 'Medically ill patients with a baseline creatinine clearance\xa0≥50', 'hospitalized medically ill patients']","['Rivaroxaban [JNJ-39039039', 'rivaroxaban 10\xa0mg or placebo', 'Rivaroxaban', 'extended-duration rivaroxaban', 'rivaroxaban', 'Post-Discharge Prophylaxis', 'placebo']","['mean baseline creatinine clearance', 'Time-to-event curves', 'fatal and major thromboembolic events', 'risk of venous and arterial fatal and major thromboembolic events', 'Venous Thromboembolic Risk', 'major bleeding', 'pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3805136', 'cui_str': 'Nonhaemorrhagic stroke'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4909.0,0.351323,"The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). ","[{'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'The Donald and Barbara Zucker School of Medicine and Hofstra/Northwell, The Feinstein Institute for Medical Research, and Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, New York, New York. Electronic address: aspyropoul@northwell.edu.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, Varese, Italy.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University Medical Center, Stanford, California.'}, {'ForeName': 'C Gregory', 'Initials': 'CG', 'LastName': 'Elliott', 'Affiliation': 'Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Halperin', 'Affiliation': 'The Cardiovascular Institute, Mount Sinai Medical Center, New York, New York.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine, Division of Cardiology, Aurora, Colorado; CPC Clinical Research, Aurora, Colorado.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Maynard', 'Affiliation': 'University of California, Davis, Sacramento, California.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, Paris, France; Imperial College, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Thrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey.'}, {'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Barnathan', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': 'Hudson College of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.04.071'] 2782,32586613,"Efficacy of Maitland joint mobilization technique on pain intensity, mouth opening, functional limitation, kinesiophobia, sleep quality and quality of life in temporomandibular joint dysfunction following bilateral cervicofacial burns.","BACKGROUND Bilateral cervicofacial burn contracture initially affects facial expressions and later affects tempero mandibular joint (TMJ) function of the patient. It further tightens the ligaments and capsules around the TMJ and leads to tempero mandibular dysfunction. The consequences of temporomandibular joint dysfunction will be pain, limitation of mouth opening, functional disability and poor quality of life (Qol). However, studies examining the efficacy of Maitland joint mobilization technique in this population are lacking. OBJECTIVES To find the short term effects of Maitland joint mobilization technique on pain, mouth opening, functional limitation, kinesiophobia, sleep quality and Quality of life in tempero mandibular joint dysfunction following bilateral cervicofacial burns. METHODS Thirty subjects with temporomandibular joint dysfunction following cervicofacial burn (N=30) were allocated to Maitland joint mobilization group (n=15) and home based training group (n=15) randomly to receive Maitland joint mobilization technique and home based training for 4 weeks. All the participants received ultrasound therapy as common treatment. Primary (Numeric Pain Rating Scale - NPRS, maximal mouth opening - MMO & Tempero mandibular disability index - TDI) and secondary (Tampa Scale of Kinesiophobia - TSK-17, Sleep quality questionnaire - SSQ & Global Rating of Change - GRC) outcome measures were measured at baseline, after four weeks and three months follow up. Repeated measures of ANOVA and independent t test were performed for analyzing the dependent variables in both groups. RESULTS Baseline demographic characters and study variables show homogenous distribution between the groups (p>0.05). Four weeks following different training protocols Maitland joint mobilization group shows more significant changes in pain intensity, mouth opening, functional limitation, kinesiophobia, sleep quality and Qol than home based training group (p≤0.05). Also Maitland joint mobilization group show significant improvement in study variables than home based training group (p≤0.05) at three months follow up. CONCLUSION Both groups improved over time, however, differences between the groups were noticed small. However, physiotherapy management which includes Maitland joint mobilization technique and therapeutic exercise program has an effective strategy in the treatment of tempero mandibular joint dysfunction following cervicofacial burns.",2020,"Four weeks following different training protocols Maitland joint mobilization group shows more significant changes in pain intensity, mouth opening, functional limitation, kinesiophobia, sleep quality and Qol than home based training group (p≤0.05).","['Thirty subjects with temporomandibular joint dysfunction following cervicofacial burn (N=30', 'temporomandibular joint dysfunction following bilateral cervicofacial burns']","['ultrasound therapy', 'Maitland joint mobilization technique', 'Maitland joint mobilization group (n=15) and home based training group (n=15) randomly to receive Maitland joint mobilization technique and home based training for 4 weeks', 'therapeutic exercise program']","['pain, limitation of mouth opening, functional disability and poor quality of life (Qol', 'Primary (Numeric Pain Rating Scale - NPRS, maximal mouth opening - MMO & Tempero mandibular disability index - TDI) and secondary (Tampa Scale of Kinesiophobia - TSK-17, Sleep quality questionnaire - SSQ & Global Rating of Change - GRC) outcome measures', 'pain intensity, mouth opening, functional limitation, kinesiophobia, sleep quality and quality of life', 'pain, mouth opening, functional limitation, kinesiophobia, sleep quality and Quality of life', 'pain intensity, mouth opening, functional limitation, kinesiophobia, sleep quality and Qol']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0039496', 'cui_str': 'Temporomandibular joint-pain-dysfunction syndrome'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",30.0,0.0488172,"Four weeks following different training protocols Maitland joint mobilization group shows more significant changes in pain intensity, mouth opening, functional limitation, kinesiophobia, sleep quality and Qol than home based training group (p≤0.05).","[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia. Electronic address: physio_gopal@rediffmail.com.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.05.017'] 2783,32586639,Phonation With a Variably Occluded Facemask: Effects of Task Duration.,"OBJECTIVE Semioccluded vocal tract (SOVT) exercises are routinely included in many voice therapy programs because they have been shown to improve acoustic, aerodynamic, and patient-reported voice outcomes. One limitation of the traditional SOVT exercise is that the nature of phonation through straws or semioccluded oral postures allows only for single phoneme production. A variably occluded facemask (VOFM) allows for use of articulated connected speech beyond the production of single phonemes, while still providing occlusion and, presumably, the vocal efficiency benefits that arise from it. This study reports on the effect of time duration of phonation with a variably occluded facemask on voice outcomes in patients with voice disorders. DESIGN Prospective, randomized cohort study. METHODS Fifteen patients with voice disorders phonated for 5 minutes through a VOFM with diameter openings of 3.2, 6.4, and 9.6 mm. Acoustic and aerodynamic voice measures were collected before and after each occlusion trial. These results were compared to a historical patient group that received the same phonation training for 2 minutes. RESULTS Positive effect sizes were found for acoustic and aerodynamic improvements for all patients for at least one occlusion diameter. Effect sizes for aerodynamic outcomes were greater in the 5-minute conditions for both the 9.6- and 6.4-mm occlusions than the 2-minute condition. Effect sizes for acoustic outcomes were greater in the 5 minute than 2-minute trial for the 9.6- and 6.4-mm occlusion diameter, but greater in the 2 minute than 5-minute trial for 3.2-mm diameter. DISCUSSION This study provides evidence that all three occlusion sizes may elicit beneficial changes for different patients; however, 5 minutes of phonation into a facemask with end occlusion of 6.4-mm diameter results in improved acoustic and aerodynamic voice outcomes for many patients with voice disorders. Future studies should further explore phonatory physiologic changes of the VOFM in a larger sample of patients and translate effects into clinical treatment for patients with voice disorders.",2020,"Effect sizes for acoustic outcomes were greater in the 5 minute than 2-minute trial for the 9.6- and 6.4-mm occlusion diameter, but greater in the 2 minute than 5-minute trial for 3.2-mm diameter. ","['patients with voice disorders', 'many patients with voice disorders', 'Fifteen patients with voice disorders phonated for 5 minutes through a VOFM with diameter openings of 3.2, 6.4, and 9.6 mm']","['Semioccluded vocal tract (SOVT) exercises', 'phonation with a variably occluded facemask', 'occluded facemask (VOFM', 'traditional SOVT exercise', 'same phonation training']","['acoustic and aerodynamic improvements', 'acoustic outcomes', 'aerodynamic outcomes', 'Acoustic and aerodynamic voice measures', 'acoustic and aerodynamic voice outcomes', 'voice outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",15.0,0.0482391,"Effect sizes for acoustic outcomes were greater in the 5 minute than 2-minute trial for the 9.6- and 6.4-mm occlusion diameter, but greater in the 2 minute than 5-minute trial for 3.2-mm diameter. ","[{'ForeName': 'Amanda I', 'Initials': 'AI', 'LastName': 'Gillespie', 'Affiliation': 'Emory University School of Medicine, Emory Voice Center, Atlanta, Georgia. Electronic address: Amanda.i.gillespie@emory.edu.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fanucchi', 'Affiliation': 'Oncology Rehab, Centennial, Colorado.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gartner-Schmidt', 'Affiliation': 'University of Pittsburgh School of Medicine, University of Pittsburgh Voice Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Belsky', 'Affiliation': 'University of Pittsburgh School of Medicine, University of Pittsburgh Voice Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Awan', 'Affiliation': 'Bloomsburg University, Bloomsburg, Pennsylvania.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.05.011'] 2784,32586741,Comparison of biodegradable synthetic polyurethane foam versus Gelfoam packing in cartilage graft myringoplasty procedures.,"OBJECTIVE To compare cartilage graft rates and graft morphologies when biodegradable Synthetic Polyurethane Foam (BSPF) and Gelfoam are used to pack the EAC after cartilage graft myringoplasty. METHODS Eighty-two patients with chronic perforations underwent endoscopic myringoplasty and were randomized to receive Gelfoam or BSPF packing of the middle ear and EAC.The groups were compared with respect to the pre- and postoperative air-bone gap (ABG), graft integrity, graft epithelialization, graft lateralization, and exudate. RESULTS Graft success rate was 87.8% in postoperative 3rd month and 87.8% in postoperative 12th month in the Gelfoam group, whereas graft success rate was 97.6% in postoperative 3rd month and 95.1% in postoperative 12th month in the BSPF group, with no statistical significance between two groups in the 3rd (P = 0.089) and 12th (P = 0.236) month after surgery. Comparing the two groups, there was no difference in preoperative or postoperative mean ABG and ABG closure. Graft lateralization or medialization was evident in 6 patients in the Gelfoam group and one in the BSPF group. Re-peroration occured in one patient in the BSPF group. CONCLUSIONS Although cartilage graft myringoplasty between Gelfoam packing and BSPF packing of EAC achieve similar graft success rate and ABG closure, BSPF packing afford better graft support and less exudation than did Gelfoam, well prevent graft lateralization and promote earlier graft epithelialization.",2020,Graft lateralization or medialization was evident in 6 patients in the Gelfoam group and one in the BSPF group.,"['cartilage graft myringoplasty procedures', 'Eighty-two patients with chronic perforations underwent endoscopic myringoplasty']","['biodegradable Synthetic Polyurethane Foam (BSPF) and Gelfoam', 'BSPF', 'biodegradable synthetic polyurethane foam versus Gelfoam packing', 'EAC', 'Gelfoam or BSPF packing of the middle ear and EAC.The']","['graft lateralization and promote earlier graft epithelialization', 'Re-peroration', 'graft success rate', 'Graft lateralization or medialization', 'Graft success rate', 'pre- and postoperative air-bone gap (ABG), graft integrity, graft epithelialization, graft lateralization, and exudate', 'preoperative or postoperative mean ABG and ABG closure']","[{'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0071696', 'cui_str': 'polyurethane foam'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C1275122', 'cui_str': 'Familial multiple trichoepitheliomata'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",82.0,0.0279966,Graft lateralization or medialization was evident in 6 patients in the Gelfoam group and one in the BSPF group.,"[{'ForeName': 'Zhengcai', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Zhengcai Lou MD Department of Otorhinolaryngology, affiliated Yiwu Hospital of Wenzhou medical university (Yiwu central hospital), Yiwu city 322000, Zhejiang provice, China. Electronic address: louzhengcai@163.com.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.06.002'] 2785,32586887,Tailored exercise is safe and beneficial for acutely hospitalised older adults with chronic obstructive pulmonary disease.,"Exercise rehabilitation programs have proven to increase exercise capacity and quality of life (QoL) in hospitalised patients with COPD. However, controversy exists as to the actual safety and effectiveness of this type of intervention We assessed the effects of an individualised exercise program on the functional capacity of acutely hospitalised older adults with COPD (as assessed with Barthel index and physical performance (Short Physical Performance Battery [SSPB]). Depression and QoL indicators, as well as serum C-reactive protein [CRP] and red blood cell distribution width [RDW] were also determined. Exercise-related side effects and incidence of readmission and mortality at 3 and 12-month-follow-up were also reported. We used the intention-to-treat approach. Of the 370 patients initially included in the RCT (11), 86 with COPD were identified (40 and 46 for the control and intervention group, respectively. The median length of stay was 8d (interquartile range, 4) for both groups. The exercise intervention improved all functional and physical performance-related outcomes (Barthel index, SPPB, 1RM leg strength) as well as depression and QoL scores, but no significant changes were found for CRP or RDW. No side effects associated were noted with the exercise sessions. No between-group differences were found for the incidence of readmission at 3 or 12-month follow-up; or for the incidence of mortality at 3 or 12-month follow-up. Our findings add to the existing limited literature supporting the benefits and safety of early rehabilitation programs in acutely hospitalised, older patients with COPD. Of note, the fact that our results were found in very older people (87 years on average) strengthens the potential safety of this type of interventions.",2020,"The exercise intervention improved all functional and physical performance-related outcomes (Barthel index, SPPB, 1RM leg strength) as well as depression and QoL scores, but no significant changes were found for CRP or RDW.","['acutely hospitalised older adults with COPD (as assessed with Barthel index and physical performance (Short Physical Performance Battery [SSPB', 'acutely hospitalised older adults with chronic obstructive pulmonary disease', 'acutely hospitalised, older patients with COPD', 'very older people (87\u2005years on average', '370 patients initially included in the RCT (11), 86 with COPD', 'hospitalised patients with COPD']","['Exercise rehabilitation programs', 'exercise intervention', 'individualised exercise program', 'Tailored exercise']","['serum C-reactive protein [CRP] and red blood cell distribution width [RDW', 'exercise capacity and quality of life (QoL', 'Exercise-related side effects and incidence of readmission and mortality', 'CRP or RDW', 'median length of stay', 'Depression and QoL indicators', 'functional and physical performance-related outcomes (Barthel index, SPPB, 1RM leg strength) as well as depression and QoL scores', 'incidence of readmission', 'incidence of mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",370.0,0.0190058,"The exercise intervention improved all functional and physical performance-related outcomes (Barthel index, SPPB, 1RM leg strength) as well as depression and QoL scores, but no significant changes were found for CRP or RDW.","[{'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Department of Systems Biology, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Hermoso', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain mikel.izquierdo@gmail.com.'}]",The European respiratory journal,['10.1183/13993003.01048-2020'] 2786,32586932,APEX: a phase II randomised clinical trial evaluating the safety and preliminary efficacy of oral X-82 to treat exudative age-related macular degeneration.,"PURPOSE The safety and efficacy of X-82, an orally administered inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor, was investigated for treatment of wet age-related macular degeneration (AMD) in a phase II clinical trial. METHODS This phase II, randomised, double-masked, placebo-controlled trial enrolled subjects with a prior diagnosis of exudative AMD having received at least two intravitreal injections of anti-VEGF therapy. Subjects were randomised equally into four groups that received either daily 50mg, 100mg or 200mg dosages of X-82 or a placebo tablet. At each 4-week interval visit for 52 weeks, subjects were to be assessed to determine if rescue treatment was needed with anti-VEGF therapy. RESULTS 157 patients were enrolled. Due to gastrointestinal and hepatobiliary adverse events and the fulfilment of the primary endpoint, the trial was stopped prematurely after a second interim analysis. The primary endpoint of non-inferiority of visual acuity compared with placebo was demonstrated in all groups receiving X-82 (p<0.001). There was a dose-dependent trend in the number of injections over a 52-week period, with the 50 mg (n=40), 100 mg (n=39), 200 mg (n=39) and placebo (n=39) group requiring 6.7, 6.0, 4.7 and 8.1 injections, respectively. CONCLUSIONS X-82 oral therapy in combination with pro re nata anti-VEGF injections showed non-inferiority in visual acuity outcomes while achieving a dose-dependent decrease in the number of anti-VEGF injections compared with placebo. Given the limited tolerability and safety issues observed, X-82 does not have a sufficient benefit to risk profile in treatment of patients with AMD.",2020,The primary endpoint of non-inferiority of visual acuity compared with placebo was demonstrated in all groups receiving X-82 (p<0.001).,"['157 patients were enrolled', 'patients with AMD', 'controlled trial enrolled subjects with a prior diagnosis of exudative AMD having received at least two', 'wet age-related macular degeneration (AMD']","['oral X-82', 'APEX', 'X-82 or a placebo tablet', 'intravitreal injections of anti-VEGF therapy', 'X-82, an orally administered inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor', 'placebo']","['non-inferiority of visual acuity', 'visual acuity outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3888896', 'cui_str': 'Wet age-related macular degeneration'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0032200', 'cui_str': 'Platelet-derived growth factor'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",157.0,0.550008,The primary endpoint of non-inferiority of visual acuity compared with placebo was demonstrated in all groups receiving X-82 (p<0.001).,"[{'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Cohen', 'Affiliation': 'The Retina Service, Ophthalmic Consultants of Boston, Boston, Massachusetts, USA mcohen@midatlanticretina.com.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Tyrogenex, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'IDDI, Inc., Raleigh, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cerami', 'Affiliation': 'Tyrogenex, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Carl C', 'Initials': 'CC', 'LastName': 'Awh', 'Affiliation': 'Tennessee Retina, Nashville, Tennessee, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Salazar', 'Affiliation': 'Tyrogenex, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosenfeld', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'The Retina Service, Ophthalmic Consultants of Boston, Boston, Massachusetts, USA.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316511'] 2787,32587489,"Efficacy and Safety of Azilsartan Medoxomil and Telmisartan in Hypertensive Patients: A Randomized, Assessor-Blinded Study.","Background Few studies have compared the safety and efficacy of azilsartan medoxomil (AZL-M) and telmisartan in hypertensive patients, especially using ambulatory blood pressure monitoring (ABPM). Objective The objective of this study was to compare the efficacy and safety profile of AZL-M and telmisartan in hypertensive patients using ABPM and clinic blood pressure (BP) monitoring. Materials and Methods This prospective, randomized, open-label, blinded endpoint, parallel-arm study included 700 patients, aged 18-70 years, with clinic and 24-h mean ambulatory systolic BP (SBP) of 150-180 mmHg and 130-170 mmHg, respectively. They were randomized equally into two groups: Group A received AZL-M 40 mg and Group T received telmisartan 40 mg; the dose was force titrated to 80 mg after 2 weeks if the response rate was not achieved. BP (clinical and ambulatory) was measured after 12 weeks and compared with baseline measurements. Results AZL-M significantly reduced the 24-h mean ambulatory SBP (Group A: 112.74 ± 7.58 mmHg; Group T: 113.96 ± 8.52 mmHg; P < 0.0001) and diastolic BP (Group A: 71.39 ± 5.89 mmHg; Group T: 67.29 ± 6.79 mmHg; P < 0.0001) compared with telmisartan at week 12. The clinic SBP significantly decreased in Group A at weeks 4 (-30.69± -0.33 mmHg) and 12 (-39.69± -1.09 mmHg) (for both, P = 0.0001). Dose titration was done in 99 and 128 patients from Group A and Group T, respectively ( P = 0.012). Headache was the most common adverse drug reaction (Group A: 21; Group T: 27) and fatigue the least. Conclusion This study found that AZL-M has greater antihypertensive efficacy than telmisartan, with comparable side effects. In addition, ABPM was shown to be a feasible method for such studies.",2020,"Dose titration was done in 99 and 128 patients from Group A and Group T, respectively ( P = 0.012).","['hypertensive patients', 'Hypertensive Patients', 'hypertensive patients using ABPM and clinic blood pressure (BP) monitoring', '700 patients, aged 18-70 years, with clinic and 24-h mean ambulatory systolic BP (SBP) of 150-180 mmHg and 130-170 mmHg, respectively']","['AZL-M', 'telmisartan', 'Azilsartan Medoxomil and Telmisartan', 'ABPM', 'AZL-M 40 mg and Group T received telmisartan', 'AZL-M and telmisartan', 'azilsartan medoxomil (AZL-M) and telmisartan']","['Efficacy and Safety', 'Headache', 'diastolic BP', 'BP (clinical and ambulatory', 'antihypertensive efficacy', '24-h mean ambulatory SBP', 'efficacy and safety profile', 'clinic SBP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C2979834', 'cui_str': 'azilsartan medoxomil 40 MG'}, {'cui': 'C0036669', 'cui_str': 'Group T'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",700.0,0.0498334,"Dose titration was done in 99 and 128 patients from Group A and Group T, respectively ( P = 0.012).","[{'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Department of Pharmacy Practice, Teerthanker Mahaveer College of Pharmacy, Teerthanker Mahaveer University, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Geetesh', 'Initials': 'G', 'LastName': 'Manik', 'Affiliation': 'Department of Cardiology, Teerthanker Mahaveer Hospital, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Department of Medicine, Teerthanker Mahaveer Medical College, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, Teerthanker Mahaveer Medical College, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Rohit K', 'Initials': 'RK', 'LastName': 'Varshney', 'Affiliation': 'Department of Anaesthesia, Teerthanker Mahaveer Medical College, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Aseem', 'Initials': 'A', 'LastName': 'Sethi', 'Affiliation': 'Department of Pharmacy Practice, Indo-Soviet Friendship College of Pharmacy, Moga, Punjab, India.'}]",Saudi journal of medicine & medical sciences,['10.4103/sjmms.sjmms_19_19'] 2788,32587525,The Acute Effects of External Compression With Blood Flow Restriction on Maximal Strength and Strength-Endurance Performance of the Upper Limbs.,"The main goal of the present study was to evaluate the acute effects external compression with blood flow restriction (BFR) at 100 and 150% of full arterial occlusion pressure (AOP) on maximal strength and strength-endurance performance during the bench press (BP) exercise. The study included 12 strength-trained male subjects (age = 23.2 ± 2.66 years; body mass = 75.3 ± 6.33 kg; height = 179.1 ± 3.82 cm), experienced in resistance training (5.7 ± 2.93 years). During the experimental sessions in a randomized crossover design, the subjects performed a 1 repetition maximum (1RM) test and three sets of the BP using 60% 1RM to failure with three different conditions: without BFR (NO-BFR); BFR with a pressure of 100% AOP (BFR 100 ); and BFR with a pressure of 150% AOP (BFR 150 ). The differences between the NO-BFR, BFR 100 , and BFR 150 conditions were examined using repeated measures ANOVA. The ANOVA indicated significant main effect for condition in 1RM, number of performed repetitions (REP), and time under tension (TUT) ( p < 0.01). Post hoc analyses for the main effect indicated significant increases in 1RM ( p < 0.01; 95.00 ± 15.37 vs 91.87 ± 15.99), REP ( p < 0.01; 17.56 ± 3.36 vs 15.67 ± 5.24), and TUT ( p < 0.01; 32.89 ± 6.40 vs 28.72 ± 6.18) for the BFR 150 condition compared to NO-BFR. Furthermore, significant increases in REP ( p = 0.03; 17.56 ± 3.36 vs 16.47 ± 4.01) and TUT ( p = 0.03; 32.89 ± 6.40 vs 30.00 ± 6.45) were observed for the BFR 150 condition compared to the BFR 100 . The results of the present study indicate that high external compression increases maximal strength evaluated by the 1RM test, as well as endurance performance during three sets of the BP exercise.",2020,"Post hoc analyses for the main effect indicated significant increases in 1RM ( p < 0.01; 95.00 ± 15.37 vs 91.87 ± 15.99), REP ( p < 0.01; 17.56 ± 3.36 vs 15.67 ± 5.24), and TUT ( p < 0.01; 32.89 ± 6.40 vs 28.72 ± 6.18) for the BFR 150 condition compared to NO-BFR.","['12 strength-trained male subjects (age = 23.2 ± 2.66 years; body mass = 75.3 ± 6.33 kg; height = 179.1 ± 3.82 cm), experienced in resistance training (5.7 ± 2.93 years']","['External Compression With Blood Flow Restriction', 'blood flow restriction (BFR) at 100 and 150% of full arterial occlusion pressure (AOP', 'bench press (BP) exercise']","['maximal strength and strength-endurance performance', 'Maximal Strength and Strength-Endurance Performance', 'REP', 'maximal strength', 'condition in 1RM, number of performed repetitions (REP), and time under tension (TUT', '1RM']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517795', 'cui_str': '5.7'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",12.0,0.0221817,"Post hoc analyses for the main effect indicated significant increases in 1RM ( p < 0.01; 95.00 ± 15.37 vs 91.87 ± 15.99), REP ( p < 0.01; 17.56 ± 3.36 vs 15.67 ± 5.24), and TUT ( p < 0.01; 32.89 ± 6.40 vs 28.72 ± 6.18) for the BFR 150 condition compared to NO-BFR.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lockie', 'Affiliation': 'Center for Sports Performance, Department of Kinesiology, California State University, Fullerton, Fullerton, CA, United States.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}]",Frontiers in physiology,['10.3389/fphys.2020.00567'] 2789,32587526,Similar Energy Expenditure During BodyPump and Heavy Load Resistance Exercise in Overweight Women.,"Purpose High-repetition, low-load resistance exercise in group class settings has gained popularity in recent years, with BodyPump as a prime example. For individuals using exercise for body-weight management, the energy expenditure during exercise is of interest. Therefore, we herein aimed to estimate the energy expenditure during a session of BodyPump and a time-matched session of heavy load resistance training in overweight women (BMI ≥ 25.0). Methods Eighteen women participated in the study (mean age 35.4 years ± 10.2, BMI 30.4 kg/m 2 ± 4.8), 10 exercising BodyPump (50-100 repetitions each muscle group) and eight performed a heavy load session (eight repetition maximum × three sets). The energy expenditure was assessed with indirect calorimetry during the sessions and for two intervals at rest during the recovery phase: 0-20 and 120-140 min after the sessions. Results The BodyPump group lifted significantly more loads than the heavy load group (19,485 kg ± 2258 vs 15,616 kg ± 2976, p = 0.006), while energy expenditure was similar with 302 kcal ± 67 and 289 kcal ± 69 in BodyPump and heavy load group, respectively ( p = 0.69). With no group differences, the resting metabolic rate (RMR) was elevated with 15-22% 2 h after exercise. Conclusion Overweight women achieved an energy expenditure of approximately 300 kcal (4.7 kcal per min) during a single session of BodyPump, which was similar with the women performing a single session of heavy load resistance exercise.",2020,"The BodyPump group lifted significantly more loads than the heavy load group (19,485 kg ± 2258 vs 15,616 kg ± 2976, p = 0.006), while energy expenditure was similar with 302 kcal ± 67 and 289 kcal ± 69 in BodyPump and heavy load group, respectively ( p = 0.69).","['Eighteen women participated in the study (mean age 35.4 years ± 10.2, BMI 30.4 kg/m 2 ± 4.8), 10 exercising BodyPump (50-100 repetitions each muscle group) and eight performed a heavy load session (eight repetition maximum × three sets', 'Overweight Women', 'overweight women (BMI ≥ 25.0']","['High-repetition, low-load resistance exercise', 'BodyPump and Heavy Load Resistance Exercise', 'BodyPump and a time-matched session of heavy load resistance training']","['energy expenditure', 'resting metabolic rate (RMR']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",18.0,0.0456149,"The BodyPump group lifted significantly more loads than the heavy load group (19,485 kg ± 2258 vs 15,616 kg ± 2976, p = 0.006), while energy expenditure was similar with 302 kcal ± 67 and 289 kcal ± 69 in BodyPump and heavy load group, respectively ( p = 0.69).","[{'ForeName': 'Anne Mette', 'Initials': 'AM', 'LastName': 'Rustaden', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gjestvang', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Lene Annette Hagen', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}]",Frontiers in physiology,['10.3389/fphys.2020.00570'] 2790,32587533,The Role of Learning Support and Chat-Sessions in Guided Internet-Based Cognitive Behavioral Therapy for Adolescents With Anxiety: A Factorial Design Study.,"Background Increased awareness of anxiety in adolescents emphasises the need for effective interventions. Internet-based cognitive behavioural therapy (ICBT) could be a resource-effective and evidence-based treatment option, but little is known about how to optimize ICBT or which factors boost outcomes. Recently, the role of knowledge in psychotherapy has received increased focus. Further, chat-sessions are of interest when trying to optimize ICBT for youths. This study aimed to evaluate the role of learning support and chat-sessions during ICBT for adolescent anxiety, using a factorial design. Method A total of 120 adolescents were randomised to one of four treatment groups, in a 2x2 design with two factors: with or without learning support and/or chat-sessions. Results Anxiety and depressive symptoms were reduced (Beck Anxiety Inventory- BAI; Cohen's d =0.72; Beck Depression Inventory- BDI; d =0.97). There was a main effect of learning support on BAI ( d =0.38), and learning support increased knowledge gain ( d  =0.42). There were no main effects or interactions related to the chat-sessions. Treatment effects were maintained at 6-months, but the added effect of learning support had by then vanished. Conclusion ICBT can be an effective alternative when treating adolescents with anxiety. Learning support could be of importance to enhance short-term treatment effects, and should be investigated further.",2020,"Results Anxiety and depressive symptoms were reduced","['Adolescents With Anxiety', '120 adolescents', 'adolescents with anxiety']","['ICBT', 'Internet-based cognitive behavioural therapy (ICBT', 'without learning support and/or chat-sessions', 'Learning Support and Chat-Sessions in Guided Internet-Based Cognitive Behavioral Therapy', 'learning support and chat-sessions']","['Anxiety and depressive symptoms', 'knowledge gain', 'awareness of anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",120.0,0.0303708,"Results Anxiety and depressive symptoms were reduced","[{'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Berg', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rozental', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'de Brun Mangs', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Näsman', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Strömberg', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Linn', 'Initials': 'L', 'LastName': 'Viberg', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Wallner', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Åhman', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Silfvernagel', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zetterqvist', 'Affiliation': 'Department of Clinical and Experimental Medicine (IKE), Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Capusan', 'Affiliation': 'Department of Clinical and Experimental Medicine (IKE), Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00503'] 2791,32587544,Parental Pre-knowledge Enhances Guidance During Inquiry-Based Family Learning in a Museum Context: An Individual Differences Perspective.,"Effective interaction and inquiry are an essential source for children's learning about science in an informal context. This study investigated the effect of parental pre-knowledge on parent-child interactions (manipulations, parent talk, and child talk) during an inquiry activity in NEMO Science Museum in Amsterdam. The sample included 105 parent-child dyads (mean children's age = 10.0 years). Half of the couples were randomly assigned to the experimental group in which, without the child's knowledge, the parent was shown the task's solution prior to the inquiry activity. Results show that parental pre-knowledge affected the way parents interacted and inquired with their child. Compared to parents without pre-knowledge, parents with pre-knowledge inquired longer, posed more open-ended wh -questions and closed questions, and less often interpreted results. Children of parents with pre-knowledge more often described evidence and interpreted results, more often manipulated alone, and solved the task more accurately. These results indicate that parental pre-knowledge brings about parents' scaffolding behavior. In addition, it was studied how individual differences of parents and children relate to parent-child interaction. Results show that children's self-reported inquiry attitude was related to their conversation during inquiry, such that they asked fewer closed questions and more open-ended questions. Children's gender affected the cooperation between parent and child, parents more often manipulated together with boys than with girls, and girls more often manipulated alone. Fathers with pre-knowledge, but not mothers, let their child manipulate more by oneself than fathers without pre-knowledge. This study shows that more knowledge about an exhibit improves a parent's scaffolding behavior in a science museum. Results are discussed in the context of museum practice.",2020,"Compared to parents without pre-knowledge, parents with pre-knowledge inquired longer, posed more open-ended wh -questions and closed questions, and less often interpreted results.","[""The sample included 105 parent-child dyads (mean children's age = 10.0 years""]",['Parental Pre-knowledge Enhances Guidance'],"[""children's self-reported inquiry attitude""]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",105.0,0.0158318,"Compared to parents without pre-knowledge, parents with pre-knowledge inquired longer, posed more open-ended wh -questions and closed questions, and less often interpreted results.","[{'ForeName': 'Rooske K', 'Initials': 'RK', 'LastName': 'Franse', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Tessa J P', 'Initials': 'TJP', 'LastName': 'Van Schijndel', 'Affiliation': 'Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Maartje E J', 'Initials': 'MEJ', 'LastName': 'Raijmakers', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01047'] 2792,32581767,Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study.,"Objective To investigate the efficacy and safety of three H. erinaceus mycelia (EAHE) capsules (350 mg/capsule; containing 5 mg/g erinacine A active ingredient) per day for the treatment of patients with mild Alzheimer's Disease (AD). Methods This study comprised a 3-week no-drug screening period, followed by a 49-week double-blind treatment period with 2-parallel groups in which eligible patients were randomized to either three 5 mg/g EAHE mycelia capsules per day or identical appearing placebo capsules. Cognitive assessments, ophthalmic examinations, biomarker collection, and neuroimaging were followed throughout the study period. Results After 49 weeks of EAHE intervention, a significant decrease in Cognitive Abilities Screening Instrument score was noted in the placebo group, a significant improvement in Mini-Mental State Examination score was observed in the EAHE group and a significant Instrumental Activities of Daily Living score difference were found between the two groups. In addition, EAHE group achieved a significantly better contrast sensitivity when compared to the placebo group. Moreover, only the placebo group observed significantly lowered biomarkers such as calcium, albumin, apolipoprotein E4, hemoglobin, and brain-derived neurotrophic factor and significantly elevated alpha1-antichymotrypsin and amyloid-beta peptide 1-40 over the study period. Using diffusion tensor imaging, the mean apparent diffusion coefficient (ADC) values from the arcuate fasciculus region in the dominant hemisphere significantly increased in the placebo group while no significant difference was found in the EAHE group in comparison to their baselines. Moreover, ADC values from the parahippocampal cingulum region in the dominant hemisphere significantly decreased in the EAHE group whereas no significant difference was found in the placebo group when compared to their baselines. Lastly, except for four subjects who dropped out of the study due to abdominal discomfort, nausea, and skin rash, no other adverse events were reported. Conclusion Three 350 mg/g EAHE capsules intervention for 49 weeks demonstrated higher CASI, MMSE, and IADL scores and achieved a better contrast sensitivity in patients with mild AD when compared to the placebo group, suggesting that EAHE is safe, well-tolerated, and may be important in achieving neurocognitive benefits. Clinical Trial Registration ClinicalTrials.gov, identifier NCT04065061.",2020,"After 49 weeks of EAHE intervention, a significant decrease in Cognitive Abilities Screening Instrument score was noted in the placebo group, a significant improvement in Mini-Mental State Examination score was observed in the EAHE group and a significant Instrumental Activities of Daily Living score difference were found between the two groups.","[""patients with mild Alzheimer's Disease (AD"", ""Early Alzheimer's Disease by Erinacine A-Enriched Hericium""]","['EAHE mycelia capsules per day or identical appearing placebo capsules', 'Placebo', 'three H. erinaceus mycelia (EAHE) capsules (350 mg/capsule; containing 5 mg/g erinacine A active ingredient', 'placebo']","['CASI, MMSE, and IADL scores', 'Instrumental Activities of Daily Living score difference', 'contrast sensitivity', 'mean apparent diffusion coefficient (ADC) values', 'Mini-Mental State Examination score', 'efficacy and safety', 'abdominal discomfort, nausea, and skin rash', 'Cognitive assessments, ophthalmic examinations, biomarker collection, and neuroimaging', 'Cognitive Abilities Screening Instrument score', 'ADC values', 'calcium, albumin, apolipoprotein E4, hemoglobin, and brain-derived neurotrophic factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4045153', 'cui_str': 'erinacine A'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1300414', 'cui_str': 'Genus Erinaceus'}, {'cui': 'C0949695', 'cui_str': 'Mycelium'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C4045153', 'cui_str': 'erinacine A'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",,0.409138,"After 49 weeks of EAHE intervention, a significant decrease in Cognitive Abilities Screening Instrument score was noted in the placebo group, a significant improvement in Mini-Mental State Examination score was observed in the EAHE group and a significant Instrumental Activities of Daily Living score difference were found between the two groups.","[{'ForeName': 'I-Chen', 'Initials': 'IC', 'LastName': 'Li', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd., Taoyuan City, Taiwan.'}, {'ForeName': 'Han-Hsin', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Chuan-Han', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Wan-Ping', 'Initials': 'WP', 'LastName': 'Chen', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd., Taoyuan City, Taiwan.'}, {'ForeName': 'Tsung-Han', 'Initials': 'TH', 'LastName': 'Lu', 'Affiliation': 'Department of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Li-Ya', 'Initials': 'LY', 'LastName': 'Lee', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd., Taoyuan City, Taiwan.'}, {'ForeName': 'Yu-Wen', 'Initials': 'YW', 'LastName': 'Chen', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd., Taoyuan City, Taiwan.'}, {'ForeName': 'Yen-Po', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd., Taoyuan City, Taiwan.'}, {'ForeName': 'Chin-Chu', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd., Taoyuan City, Taiwan.'}, {'ForeName': 'David Pei-Cheng', 'Initials': 'DP', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung City, Taiwan.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.00155'] 2793,32581768,Enriching Hippocampal Memory Function in Older Adults Through Real-World Exploration.,"Age-related structural and functional changes in the hippocampus can have a severe impact on hippocampal-dependent memory performance. Here, we tested the hypothesis that a real-world spatial exploration and learning intervention would improve hippocampal-dependent memory performance in healthy older adults. We developed a scavenger hunt task that participants performed over the course of a 4-week behavioral intervention period. Following this intervention, participants' lure discrimination index (LDI) on the Mnemonic Similarity Task was significantly higher than it was at baseline and greater than that of a No-Contact Control Group, while traditional recognition scores remained relatively unchanged. These results point to the viability of a spatial exploration intervention for improving hippocampal-dependent memory in older adults.",2020,"Here, we tested the hypothesis that a real-world spatial exploration and learning intervention would improve hippocampal-dependent memory performance in healthy older adults.","['healthy older adults', 'Older Adults', 'older adults']","['spatial exploration intervention', 'real-world spatial exploration and learning intervention']","['lure discrimination index (LDI) on the Mnemonic Similarity Task', 'traditional recognition scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0397877,"Here, we tested the hypothesis that a real-world spatial exploration and learning intervention would improve hippocampal-dependent memory performance in healthy older adults.","[{'ForeName': 'Branden S', 'Initials': 'BS', 'LastName': 'Kolarik', 'Affiliation': 'Department of Neurobiology and Behavior, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Shauna M', 'Initials': 'SM', 'LastName': 'Stark', 'Affiliation': 'Department of Neurobiology and Behavior, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Craig E L', 'Initials': 'CEL', 'LastName': 'Stark', 'Affiliation': 'Department of Neurobiology and Behavior, University of California, Irvine, Irvine, CA, United States.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.00158'] 2794,32581890,Efficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression-A Randomized Controlled Trial.,"Introduction Accumulating evidence indicates the effectiveness of cryogenic temperature interventions in rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, multiple sclerosis, and chronic low back pain. The application of whole-body cryotherapy (WBC) in psychiatric aspects of medicine was also noted. Nevertheless, the exact mechanisms explaining the beneficial effect of WBC on mood disorders remain unclear. The study aimed to assess the efficacy of repetitive short exposure to extremely low temperatures (WBC) on mood, quality of life as well as on biochemical measures among people diagnosed with depressive episode undergoing pharmacological treatment. Materials and Methods Prospective randomized, double-blind sham-controlled protocol was used. The study enrolled 92 medically stable adults (aged 20-73 years) with a diagnosis of a depressive episode. The participants were randomly allocated and exposed to 10 whole-body cryotherapy (WBC) sessions (-110°C till -160°C [the experimental group (EG)] or to low, but not cryogenic temperatures -50°C [the control group (CG)]. Thirty participants in the EG and 26 in CG completed the whole study. The primary outcome measures were depressive symptoms evaluated with the Beck Depression Inventory-II (BDI-II) as well as the Hamilton Depression Rating Scale (HAM-D 17). The quality of life, quality of sexual life, acceptance of the disease and self-reported mood, vitality, and sleep quality were assessed as secondary outcome measures. The study was registered at Australian New Zealand Clinical Trials Registry (ACTRN12619001600134). Results The results show evidence for a statistically significant difference in the clinical assessment of depressive symptoms according to HAM-D 17 scale (T4 by group interaction p=0.02), BDI-II (T2 time by group interaction p=0.01), cognitive-affective BDI dimension (T4 by group interaction p=0.00), and somatic BDI dimension (T4 by group interaction p=0.028). Significant improvement was also noticed in life quality (p < 0.05), self-assessed mood (p=0.035), and disease acceptance (p=0.007). There were no statistically significant changes related to sexual satisfaction, self-assessed vitality, and sleep (p > 0.05). Conclusions Whole-body cryotherapy is a useful method to improve standard pharmacological treatment. The WBC intervention reduces mental health deterioration, especially in mood disorders, such as depression, and can be beneficial for well-being and quality of life.",2020,"The results show evidence for a statistically significant difference in the clinical assessment of depressive symptoms according to HAM-D 17 scale (T4 by group interaction p=0.02), BDI-II (T2 time by group interaction p=0.01), cognitive-affective BDI dimension (T4 by group interaction p=0.00), and somatic BDI dimension (T4 by group interaction p=0.028).","['Thirty participants in the EG and 26 in CG completed the whole study', 'people diagnosed with depressive episode undergoing pharmacological treatment', '92 medically stable adults (aged 20-73 years) with a diagnosis of a depressive episode']","['Whole-Body Cryotherapy', 'WBC intervention', 'cryogenic temperature interventions', 'repetitive short exposure to extremely low temperatures (WBC', '10 whole-body cryotherapy (WBC) sessions (-110°C till -160°C [the experimental group (EG)] or to low, but not cryogenic temperatures -50', 'whole-body cryotherapy (WBC']","['cognitive-affective BDI dimension', 'clinical assessment of depressive symptoms', 'self-assessed mood', 'depressive symptoms evaluated with the Beck Depression Inventory-II (BDI-II) as well as the Hamilton Depression Rating Scale (HAM-D 17', 'disease acceptance', 'somatic BDI dimension', 'mood, quality of life', 'quality of life, quality of sexual life, acceptance of the disease and self-reported mood, vitality, and sleep quality', 'sexual satisfaction, self-assessed vitality, and sleep', 'BDI-II (T2 time', 'life quality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",92.0,0.0613344,"The results show evidence for a statistically significant difference in the clinical assessment of depressive symptoms according to HAM-D 17 scale (T4 by group interaction p=0.02), BDI-II (T2 time by group interaction p=0.01), cognitive-affective BDI dimension (T4 by group interaction p=0.00), and somatic BDI dimension (T4 by group interaction p=0.028).","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rymaszewska', 'Affiliation': 'Department of Psychiatry, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Katarzyna M', 'Initials': 'KM', 'LastName': 'Lion', 'Affiliation': 'Department of Psychiatry, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Lilla', 'Initials': 'L', 'LastName': 'Pawlik-Sobecka', 'Affiliation': 'Department of Nervous System Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Pawłowski', 'Affiliation': 'Department of Psychiatry, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Szcześniak', 'Affiliation': 'Department of Psychiatry, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Trypka', 'Affiliation': 'Department of Psychiatry, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Rymaszewska', 'Affiliation': 'Student Scientific Association at Department of Psychiatry, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Zabłocka', 'Affiliation': 'Laboratory of Microbiome Immunobiology, Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Wroclaw, Poland.'}, {'ForeName': 'Bartlomiej', 'Initials': 'B', 'LastName': 'Stanczykiewicz', 'Affiliation': 'Department of Nervous System Diseases, Wroclaw Medical University, Wroclaw, Poland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00522'] 2795,32581910,What to Say When Seeking Support Online: A Comparison Among Different Levels of Self-Disclosure.,"The current study examined the effect of exposure to online support-seeking posts containing different levels of depth self-disclosure (baseline, peripheral, core) affecting the quality (person-centeredness and politeness) of participants' support-provision messages. Participants of the study were assigned to the role of a support-provider. Compared to participants who read support-seeking posts with baseline and core self-disclosure, participants who read support-seeking posts with peripheral self-disclosure rated the support-seekers as less anonymous. Compared to participants who read support-seeking posts in the baseline condition, participants who read the support-seeking posts with peripheral self-disclosure wrote support-provision messages with higher level of person-centeredness and politeness. Participants' perceived anonymity of the support-seekers mediated the effect of the depth of self-disclosure on the politeness of the response messages.",2020,Participants' perceived anonymity of the support-seekers mediated the effect of the depth of self-disclosure on the politeness of the response messages.,[],[],[],[],[],[],,0.0361035,Participants' perceived anonymity of the support-seekers mediated the effect of the depth of self-disclosure on the politeness of the response messages.,"[{'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'School of Journalism and Communication, Renmin University of China, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Communication, University of California, Davis, Davis, CA, United States.'}, {'ForeName': 'V Skye', 'Initials': 'VS', 'LastName': 'Wingate', 'Affiliation': 'Department of Communication, University of California, Davis, Davis, CA, United States.'}, {'ForeName': 'Siyue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'College of Media and International Culture, Zhejiang University, Hangzhou, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00978'] 2796,32581933,Attentional Bias and Training in Individuals With High Dental Anxiety.,"Dental anxiety is common and associated with negative outcomes. According to information-processing models, anxiety is maintained by maladaptive patterns of processing threatening information. Furthermore, attention training interventions can reduce anxiety in one session. Fifty-three individuals with high levels of dental anxiety completed a Posner reaction-time task. Participants were randomized to attention training or control using a dot-probe task, and then attentional bias was remeasured using another Posner task. Participants then completed a script-driven imaginal exposure task. Results indicated that individuals high in dental anxiety exhibit threat-relevant attentional bias. There was mixed evidence about the efficacy of attention training. On the one hand, training did not eliminate attentional bias and training condition did not predict distress during the imagery task. On the other hand, cue dependency scores in the control group were higher for dental than neutral cues, but did not differ in the training group. In addition, cue dependency scores for both dental and neutral cues predicted subjective anxiety in anticipation of the imagery task. The mixed results of training are considered in terms of the possibility that it enhanced attentional control, rather than reducing bias.",2020,"On the other hand, cue dependency scores in the control group were higher for dental than neutral cues, but did not differ in the training group.","['Individuals With High Dental Anxiety', 'Fifty-three individuals with high levels of dental anxiety completed a Posner reaction-time task']","['attention training or control using a dot-probe task, and then attentional bias was remeasured using another Posner task', 'script-driven imaginal exposure task']","['cue dependency scores', 'Attentional Bias and Training', 'dental anxiety exhibit threat-relevant attentional bias', 'Dental anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",53.0,0.0186746,"On the other hand, cue dependency scores in the control group were higher for dental than neutral cues, but did not differ in the training group.","[{'ForeName': 'Jedidiah', 'Initials': 'J', 'LastName': 'Siev', 'Affiliation': 'Department of Psychology, Swarthmore College, Swarthmore, PA, United States.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Behar', 'Affiliation': 'Department of Psychology, Hunter College, The City University of New York, New York, NY, United States.'}, {'ForeName': 'Meghan R', 'Initials': 'MR', 'LastName': 'Fortune', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01057'] 2797,32582409,The Effect of Information Therapy on Treatment Adherence among Patients Referred to Addiction Treatment Centers.,"Background The low level of drug adherence in addicts who are quitting is one of the biggest challenges in the treatment and management of this disease. Therefore, this study aimed to evaluate the effect of information therapy on adherence to treatment among the patients in addiction treatment centers. Methods The present quasi-experimental study was performed on 60 patients referred to addiction treatment centers in Jiroft City, Iran. The control and experimental groups were selected using simple random sampling method. The 8-item Morisky Medication Adherence Scale was used for data collection. The level of adherence to treatment was assessed before and after the intervention, which consisted of 6 one-hour training sessions per week. Findings The adherence to medication was low in both experimental and control groups before the notification. However, the chi-square value obtained by comparing the frequencies of the experimental and control groups in three variables of adherence level (high, moderate, and low) was 9.84 which was statistically significant (P = 0.007). Therefore, there was a significant difference between the experimental and control groups after information therapy. In fact, the information in the experimental group had a significant and positive effect. Conclusion Because of the low level of adherence to treatment, it is recommended to use information therapy to give information on timely and correct use of drugs as well as its importance in the treatment of addiction; so that the level of adherence would improve.",2020,The adherence to medication was low in both experimental and control groups before the notification.,"['patients in addiction treatment centers', 'Patients Referred to Addiction Treatment Centers', '60 patients referred to addiction treatment centers in Jiroft City, Iran']","['Information Therapy', 'information therapy']","['8-item Morisky Medication Adherence Scale', 'adherence level', 'adherence to medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",60.0,0.0292757,The adherence to medication was low in both experimental and control groups before the notification.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azami', 'Affiliation': 'Medical Informatics Research Center, Institute of Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Motahareh', 'Initials': 'M', 'LastName': 'Pilevarzadeh', 'Affiliation': 'School of Nursing, Jiroft University of Medical Sciences, Jiroft, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Sharifi', 'Affiliation': 'Modeling in Health Research Center, Institute of Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",Addiction & health,['10.22122/ahj.v12i1.261'] 2798,32582447,"Differences in alexithymia, emotional awareness, and facial emotion recognition under conditions of self-focused attention among women with high and low eating disorder symptoms: a 2 x 2 experimental study.","Background Women with eating disorders generally perform more poorly on measures of alexithymia, defined as difficulty identifying and describing emotions, and theory of mind, or the ability to infer what others are thinking and feeling. The extent to which these abilities may be influenced by variables such as self-focused attention, or directing attention toward internally generated information, has yet to be investigated. Thus, the purpose of the present study was to examine differences between women high and low in disordered eating symptoms on measures of emotional awareness and facial affect recognition under conditions of high and low self-focused attention. Methods University women scoring high or low on a measure of disordered eating ( n  = 79) were randomly assigned to a condition of high or low self-focused attention. Outcomes included alexithymia (self-rated ability to identify and describe emotions), emotional awareness (ability to describe the emotions of oneself and others), and facial affect recognition. Scores on a measure of negative affect were statistically controlled. Results Women with high disordered eating symptom scores rated themselves as having more difficulties identifying, but not describing emotions after controlling for negative affect, but demonstrated greater difficulties describing their own and others' emotions on a measure of emotional awareness. In the self-focused attention condition, women scored lower on self emotional awareness and were quicker to identify expressions of negative facial affect regardless of eating disorder symptom status than women in the non-self-focused attention condition. There were no significant interactions between eating disorder status and self-focused attention. Conclusions Further examination of different types of emotion recognition and description in oneself and others as well as processes that may influence these abilities is warranted.",2020,"In the self-focused attention condition, women scored lower on self emotional awareness and were quicker to identify expressions of negative facial affect regardless of eating disorder symptom status than women in the non-self-focused attention condition.","['women with high and low eating disorder symptoms', 'Methods\n\n\nUniversity women scoring high or low on a measure of disordered eating ( n \xa0=\u200979', '\n\n\nWomen with eating disorders']",['condition of high or low self-focused attention'],"['eating disorder status and self-focused attention', 'alexithymia, emotional awareness, and facial emotion recognition under conditions of self-focused attention', 'eating disorder symptom status', 'self emotional awareness', 'alexithymia (self-rated ability to identify and describe emotions), emotional awareness (ability to describe the emotions of oneself and others), and facial affect recognition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}]","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",79.0,0.0663667,"In the self-focused attention condition, women scored lower on self emotional awareness and were quicker to identify expressions of negative facial affect regardless of eating disorder symptom status than women in the non-self-focused attention condition.","[{'ForeName': 'Jillon S', 'Initials': 'JS', 'LastName': 'Vander Wal', 'Affiliation': 'Department of Psychology, Saint Louis University, 3700 Lindell Blvd, St. Louis, MO 63108 USA.'}, {'ForeName': 'Alicia A', 'Initials': 'AA', 'LastName': 'Kauffman', 'Affiliation': 'Behavioral Medicine & Psychiatry, Chestnut Ridge Center, West Virginia University School of Medicine, 930 Chestnut Ridge Road, Morgantown, WV 26505 USA.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Soulliard', 'Affiliation': 'East Hawaii Family Guidance Center in Hilo, 88 Kanoelehua Avenue, Hilo, HI 96720 USA.'}]",Journal of eating disorders,['10.1186/s40337-020-00304-5'] 2799,32582491,Efficacy of Dexmedetomidine vs Morphine as an Adjunct in a Paravertebral Block with Bupivacaine in Postoperative Analgesia Following Modified Radical Mastectomy.,"Objective To observe the efficacy of dexmedetomidine vs morphine as an adjunct in a paravertebral block (PVB) with bupivacaine in postoperative analgesia following modified radical mastectomy. Study design This was a randomized controlled trial performed from June 2018 to August 2019 in the Department of Anesthesia, Bakhtawar Amin Medical and Dental College, Ch. Pervaiz Ellahi Institute of Cardiology, Multan, Gurki Hospital, Services Institute of Medical Sciences, and Sheikh Zayed Hospital, Lahore. Methodology Seventy-eight patients were equally divided into group M, which received morphine (3 mg) and group D, which received dexmedetomidine (1 µg/kg), along with 20 cc 0.25% bupivacaine, for PVB. The primary outcome included morphine requirements in the post-anesthesia care unit (PACU). Secondary outcomes included the quality and duration of analgesia, intraoperative doses of fentanyl and propofol, postoperative doses of diclofenac required, postoperative nausea and vomiting (PONV), and the Ramsey sedation score. Data were entered into SPSS version 23 (IBM Corp., Armonk, NY) and analyzed by applying the independent t-test, Mann Whitney U-test, and the chi-square test or Fischer's exact test, as appropriate. P≤0.05 was considered statistically significant. Results The mean time for the first analgesic administration was much shorter in group D as compared to group M (p<0.001). The average doses of ephedrine and morphine used were higher in group D (p-value 0.033 and 0.013, respectively). In the PACU, 33.3% of group D patients as compared to 12.8% of group M patients needed morphine (p=0.032). Postoperatively, diclofenac consumption was higher in group D (p<0.001). Postoperative pain was lower and sedation was higher in group M (p<0.05). Conclusion As an adjunct to bupivacaine in PVB for MRM, morphine is superior to dexmedetomidine.",2020,"The average doses of ephedrine and morphine used were higher in group D (p-value 0.033 and 0.013, respectively).","['Methodology Seventy-eight patients', 'Postoperative Analgesia Following Modified Radical Mastectomy', 'from June 2018 to August 2019 in the Department of Anesthesia, Bakhtawar Amin Medical and Dental College, Ch', 'postoperative analgesia following modified radical mastectomy']","['ephedrine and morphine', 'Bupivacaine', 'bupivacaine', 'bupivacaine, for PVB', 'Dexmedetomidine vs Morphine', 'dexmedetomidine vs morphine', 'dexmedetomidine', 'morphine']","['diclofenac consumption', 'morphine requirements in the post-anesthesia\xa0care unit (PACU', 'mean time for the first analgesic administration', 'Postoperative pain', 'quality and duration of analgesia, intraoperative doses of fentanyl and propofol, postoperative doses of diclofenac required,\xa0postoperative nausea and vomiting (PONV), and the Ramsey sedation score']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",78.0,0.0379288,"The average doses of ephedrine and morphine used were higher in group D (p-value 0.033 and 0.013, respectively).","[{'ForeName': 'Malik Jamil', 'Initials': 'MJ', 'LastName': 'Ahmed', 'Affiliation': 'Anaesthesia, Bakhtawar Amin Medical and Dental College, Multan, PAK.'}, {'ForeName': 'Abaid', 'Initials': 'A', 'LastName': 'Ur Rehman', 'Affiliation': 'Anaesthesia, Lahore Medical and Dental College, Ghurki Trust Teaching Hospital, Lahore, PAK.'}, {'ForeName': 'Rana Muhammad', 'Initials': 'RM', 'LastName': 'Arshad', 'Affiliation': 'Anaesthesia, Bakhtawar Amin Medical and Dental College, Multan, PAK.'}, {'ForeName': 'Muhammad Wasim Ali', 'Initials': 'MWA', 'LastName': 'Amjad', 'Affiliation': 'Anaesthesia, Services Institute of Medical Sciences, Lahore, PAK.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Anaesthesia, Sheikh Zayed Medical College and Hospital, Rahim Yar Khan, PAK.'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Furqan', 'Affiliation': 'Anaesthesia and Critical Care, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}]",Cureus,['10.7759/cureus.8231'] 2800,32582583,Pre-discharge Cardiorespiratory Monitoring in Preterm Infants. the CORE Study.,"Objective: Ensuring cardiorespiratory (CR) stability is essential for a safe discharge. The aim of this study was to assess the impact of a new pre-discharge protocol named CORE on the risk of hospital readmission (RHR). Methods: Preterm infants admitted in our NICU between 2015 and 2018 were randomly assigned to CORE (exposed) or to standard (not-exposed) discharge protocol. CORE included 24 h-clinical observation, followed by 24 h-instrumental CR monitoring only for high-risk infants. RHR 12 months after discharge and length of stay represent the primary and secondary outcomes, respectively. Results: Three hundred and twenty three preterm infants were enrolled. Exposed infants had a lower RHR (log-rank p < 0.05). The difference was especially marked 3 months after discharge (9.09 vs. 21.6%; p = 0.004). The hospital length of stay in exposed and not-exposed infants was 39(26-58) and 43(26-68) days, respectively ( p = 0.16). Conclusions: The CORE protocol could help neonatologists to define the best timing for discharge reducing RHR without lengthening hospital stay.",2020,The difference was especially marked 3 months after discharge (9.09 vs. 21.6%; p = 0.004).,"['Preterm infants admitted in our NICU between 2015 and 2018 were randomly assigned to', 'Preterm Infants', 'Three hundred and twenty three preterm infants were enrolled']","['cardiorespiratory', 'CORE (exposed) or to standard (not-exposed) discharge protocol']","['hospital length of stay', 'risk of hospital readmission (RHR']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}]",323.0,0.149541,The difference was especially marked 3 months after discharge (9.09 vs. 21.6%; p = 0.004).,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cresi', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Cocchi', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Maggiora', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Pirra', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Logrippo', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Ariotti', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Peila', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Bertino', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Coscia', 'Affiliation': 'Neonatal Intensive Care Unit, City of Health and Science-University of Turin, Turin, Italy.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00234'] 2801,32582666,Classification of Infected Necrotizing Pancreatitis for Surgery Within or Beyond 4 Weeks Using Machine Learning.,"Background: The timing of surgery for necrotizing pancreatitis remains a matter of controversial debate, which has not been resolved by randomized controlled trial (RCT). This study aims to classify surgical timing within or beyond 4 weeks for patients with infected necrotizing pancreatitis by using machine learning methods. Methods: This study analyzed 223 patients who underwent surgery for infected pancreatic necrosis at West China Hospital of Sichuan University. We used logistic regression, support vector machine, and random forest with/without the simulation of generative adversarial networks to classify the surgical intervention within or beyond 4 weeks in the patients with infected necrotizing pancreatitis. Results: Our analyses showed that interleukin 6, infected necrosis, the onset of fever and C-reactive protein were important factors in determining the timing of surgical intervention (< 4 or ≥ 4 weeks) for the patients with infected necrotizing pancreatitis. The main factors associated with postoperative mortality in patients who underwent early surgery (< 4 weeks) included modified Marshall score on admission and preoperational modified Marshall score. Preoperational modified Marshall score, time of surgery, duration of organ failure and onset of renal failure were important predictive factors for the postoperative mortality of patients who underwent delayed surgery (≥ 4 weeks). Conclusions: Machine learning models can be used to predict timing of surgical intervention effectively and key factors associated with surgical timing and postoperative survival are identified for infected necrotizing pancreatitis.",2020,"Preoperational modified Marshall score, time of surgery, duration of organ failure and onset of renal failure were important predictive factors for the postoperative mortality of patients who underwent delayed surgery (≥ 4 weeks). ","['patients with infected necrotizing pancreatitis by using machine learning methods', 'patients who underwent delayed surgery (≥ 4 weeks', '223 patients who underwent surgery for infected pancreatic necrosis at West China Hospital of Sichuan University', 'patients with infected necrotizing pancreatitis']",[],"['postoperative mortality', 'modified Marshall score on admission and preoperational modified Marshall score', 'Preoperational modified Marshall score, time of surgery, duration of organ failure and onset of renal failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0341479', 'cui_str': 'Infected pancreatic necrosis'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}]",223.0,0.0585978,"Preoperational modified Marshall score, time of surgery, duration of organ failure and onset of renal failure were important predictive factors for the postoperative mortality of patients who underwent delayed surgery (≥ 4 weeks). ","[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Vascular Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Information Management and Statistics, Hubei University of Economics, Wuhan, China.'}, {'ForeName': 'Weiling', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Pancreatic Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zongguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Digest Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, TX, United States.'}]",Frontiers in bioengineering and biotechnology,['10.3389/fbioe.2020.00541'] 2802,32582732,An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial.,"Maintaining the ability to walk is one of the significant challenges in people with multiple sclerosis (MS) for keeping a good quality of life as the disease and the aging process progresses. Overground robotic (OR) wearable exoskeletons are promising tools for gait rehabilitation, but currently there is no evidence of their clinical effects on patients with MS. The present study aims to determine the effects of an OR intervention in people with MS and moderate to severe walking disabilities and ascertain if benefits are maintained over a follow-up period of 3 months. This randomized controlled trial will include 36 participants with MS. Inclusion criteria are: older than 18 years, definitive diagnosis of MS, 4.5-7 points on the EDSS (Expanded Disability Status Scale), and needing one or two canes or crutches for walking outdoors. Subjects in the control group will receive conventional physiotherapy sessions at ADEMBI (Asociación de Esclerosis Múltiple de Bizkaia) provided to control spasticity, maintain articular range and exercise balance. Subjects in the intervention group will receive the same physiotherapy but also participate in a progressive OR gait training program assisted by the Ekso TM exoskeleton. The program consists of twice a week individually supervised sessions in two setting modalities: PreGait and ProStepPlus . The training parameters (duration, speed, cadence, length of steps) will be set during the first session and the progression and intensity of the intervention will be adapted to the tolerance of each participant. The primary outcome of this study is gait speed. Secondary outcomes will include physical and cognitive performance tests, clinical, fatigue and quality of life assessments, and changes in the plasma levels of inflammatory cytokines. The present trial is the first analyzing the effectiveness of an OR intervention for gait training in patients with MS. It will help clarify the applicability of robotic technologies to clinical practice, extending the functionality and quality of life of people with MS to face a successful aging process. (ACTRN12619000014156; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376548).",2020,"It will help clarify the applicability of robotic technologies to clinical practice, extending the functionality and quality of life of people with MS to face a successful aging process.","['people with multiple sclerosis (MS', 'patients with MS', 'People With Multiple Sclerosis', 'people with MS and moderate to severe walking disabilities', 'Inclusion criteria are: older than 18 years, definitive diagnosis of MS, 4.5-7 points on the EDSS (Expanded Disability Status Scale), and needing one or two canes or crutches for walking outdoors', '36 participants with MS']","['conventional physiotherapy sessions at ADEMBI (Asociación de Esclerosis Múltiple de Bizkaia) provided to control spasticity, maintain articular range and exercise balance', 'same physiotherapy but also participate in a progressive OR gait training program assisted by the Ekso TM exoskeleton', 'OR intervention', 'Overground robotic (OR) wearable exoskeletons', 'Overground Robotic Gait Training Program']","['physical and cognitive performance tests, clinical, fatigue and quality of life assessments, and changes in the plasma levels of inflammatory cytokines', 'training parameters (duration, speed, cadence, length of steps', 'gait speed']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0010397', 'cui_str': 'Crutches'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4707653', 'cui_str': 'Cognitive Performance Test'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",36.0,0.0448068,"It will help clarify the applicability of robotic technologies to clinical practice, extending the functionality and quality of life of people with MS to face a successful aging process.","[{'ForeName': 'Rakel', 'Initials': 'R', 'LastName': 'Berriozabalgoitia', 'Affiliation': 'ADEMBI, Multiple Sclerosis Association of Bizkaia, Bilbao, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Sanz', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Fraile-Bermúdez', 'Affiliation': 'Department of Nursing I, Faculty of Medicine and Nursery, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Otxoa', 'Affiliation': 'ADEMBI, Multiple Sclerosis Association of Bizkaia, Bilbao, Spain.'}, {'ForeName': 'Izaskun', 'Initials': 'I', 'LastName': 'Yeregui', 'Affiliation': 'ADEMBI, Multiple Sclerosis Association of Bizkaia, Bilbao, Spain.'}, {'ForeName': 'Iraia', 'Initials': 'I', 'LastName': 'Bidaurrazaga-Letona', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Duñabeitia', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Antigüedad', 'Affiliation': 'Biocruces-Bizkaia Research Institute, Department of Neurology, Cruces University Hospital, Osakidetza Basque Health Service, Barakaldo, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Domercq', 'Affiliation': 'Department of Neurosciences, University of the Basque Country, Achucarro Basque Center for Neuroscience-UPV/EHU, Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (CIBERNED), Leioa, Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}]",Frontiers in medicine,['10.3389/fmed.2020.00238'] 2803,32582744,Activity and Health During the SARS-CoV2 Pandemic (ASAP): Study Protocol for a Multi-National Network Trial.,"Introduction: The worldwide spread of the novel coronavirus (SARS-CoV2) has prompted numerous countries to restrict public life. Related measures, such as limits on social gatherings, business closures, or lockdowns, are expected to considerably reduce the individual opportunities to move outside the home. As physical activity (PA) and sport participation significantly contribute to health, this study has two objectives. The objectives of this study are to assess changes in PA and well-being since the coronavirus outbreak in affected countries. Additionally, we will evaluate the impact of digital home-based exercise programs on PA as well as physical and mental health outcomes. Method: A multinational network trial will be conducted with three planned phases (A, B, and C). Part A consists of administering a structured survey. It investigates changes in PA levels and health during the coronavirus outbreak and measures the preferences of the participants regarding online training programs. Part B is a two-armed randomized-controlled trial. Participants assigned to the intervention group (IG) will complete a digital 4-week home exercise training (live streaming via internet) guided by the survey results on content and time of program. The control group (CG) will not receive the program. Part C is 4-week access of both CG and IG to a digital archive of pre-recorded workouts from Part B. Similar to Part A, questionnaires will be used in both Part B and C to estimate the effects of exercise on measures of mental and physical health. Results and Discussion: The ASAP project will provide valuable insights into the importance of PA during a global pandemic. Our initial survey is the first to determine how governmental confinement measures impact bodily and mental well-being. Based on the results, the intervention studies will be unique to address health problems potentially arising from losses in PA. If proven effective, the newly developed telehealth programs could become a significant and easy-to-distribute factor in combating PA decreases. Results of the study may hence guide policy makers on methods to maintain PA and health when being forced to restrict public life. Study Register: DRKS00021273.",2020,It investigates changes in PA levels and health during the coronavirus outbreak and measures the preferences of the participants regarding online training programs.,[],"['digital home-based exercise programs', 'intervention group (IG) will complete a digital 4-week home exercise training (live streaming via internet) guided by the survey results on content and time of program']","['PA levels and health', 'Activity and Health']",[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0240049,It investigates changes in PA levels and health during the coronavirus outbreak and measures the preferences of the participants regarding online training programs.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mohr', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Tenforde', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Vogel', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Hespanhol', 'Affiliation': ""Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': 'Amsterdam Collaboration on Health and Safety in Sports, Department of Public and Occupational Health, Amsterdam Movement Sciences, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Hollander', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, United States.'}]",Frontiers in medicine,['10.3389/fmed.2020.00302'] 2804,32582755,Impact of Post-Exercise Fructose-Maltodextrin Ingestion on Subsequent Endurance Performance.,"Background: Current sports nutrition guidelines recommend athletes ingest carbohydrates at 1.0-1.2 g·kg -1 ·h -1 to optimize repletion of muscle glycogen during short-term recovery from endurance exercise. However, they do not provide specific advice on monosaccharides (e.g., fructose or glucose) other than to ingest carbohydrates of moderate to high glycaemic index. Recent evidence suggests that combined ingestion of fructose and glucose in recovery leads to enhanced liver glycogen synthesis and that this translates into improvement of subsequent endurance capacity. Purpose: The purpose of the present study was to investigate whether consuming a combination of fructose and glucose as opposed to glucose alone during short-term recovery (i.e., 4 h) from exhaustive exercise would also improve subsequent pre-loaded cycle time trial (TT) performance. Methods: Eight participants (seven men, one woman; V ∙ O 2 peak: 56.8 ± 5.0 mLO 2 ·min -1 ·kg -1 ; Wmax: 352 ± 41 W) participated in this randomized double-blind study. Each experimental session involved a glycogen reducing exercise bout in the morning, a 4-h recovery period and 1-h of steady state (SS) exercise at 50% Wmax followed by a ~40-min simulated TT. During recovery carbohydrates were ingested at a rate of 1.2 g·kg -1 ·h -1 in the form of fructose and maltodextrin (FRU + MD) or dextrose and maltodextrin (GLU + MD) (both in 1:1.5 ratio). Substrate oxidation rates, including ingested carbohydrate oxidation, were determined during the steady state (SS). Blood samples were collected during recovery, during the SS exercise and at the end of the TT for determination of glucose and lactate concentrations. Results: There were no differences in TT performance [37.41 ± 3.45 (GLU + MD); 37.96 ± 5.20 min (FRU + MD), p = 0.547]. During the first 45-min of SS oxidation of ingested carbohydrates was greater in FRU + MD (1.86 ± 0.41 g -1 ·min -1 and 1.51 ± 0.37 g -1 ·min -1 for FRU + MD and GLU + MD, respectively; time x condition interaction p = 0.003) and there was a trend toward higher overall carbohydrate oxidation rates in FRU + MD (2.50 ± 0.36 g -1 ·min -1 and 2.31 ± 0.37 g -1 ·min -1 for FRU + MD and GLU + MD, respectively; p = 0.08). However, at 60-min of SS, differences in substrate oxidation disappeared. Conclusion: Ingestion of combined fructose and glucose compared to glucose only during recovery from an exhaustive exercise bout increased the ingested carbohydrate oxidation rate during subsequent exercise. Under the conditions studied, subsequent TT performance was not improved with fructose-glucose.",2020,"During the first 45-min of SS oxidation of ingested carbohydrates was greater in FRU + MD (1.86 ± 0.41 g -1 ·min -1 and 1.51 ± 0.37 g -1 ·min -1 for FRU + MD and GLU + MD, respectively; time x condition interaction p = 0.003) and there was a trend toward higher overall carbohydrate oxidation rates in FRU + MD (2.50 ± 0.36 g -1 ·min -1 and 2.31 ± 0.37","['Eight participants (seven men, one woman; V']","['fructose and maltodextrin (FRU + MD) or dextrose and maltodextrin (GLU + MD', 'combined fructose and glucose', 'glycogen reducing exercise bout in the morning, a 4-h recovery period and 1-h of steady state (SS) exercise at 50% Wmax followed by a ~40-min simulated TT', 'fructose and glucose', 'Post-Exercise Fructose-Maltodextrin Ingestion']","['overall carbohydrate oxidation rates', 'Substrate oxidation rates, including ingested carbohydrate oxidation', 'substrate oxidation', 'ingested carbohydrate oxidation rate', 'Subsequent Endurance Performance', 'FRU + MD', 'subsequent TT performance', 'TT performance', 'subsequent pre-loaded cycle time trial (TT) performance']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0061055', 'cui_str': 'gamma-glutamyl-alpha-aminobutyrate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",,0.0792095,"During the first 45-min of SS oxidation of ingested carbohydrates was greater in FRU + MD (1.86 ± 0.41 g -1 ·min -1 and 1.51 ± 0.37 g -1 ·min -1 for FRU + MD and GLU + MD, respectively; time x condition interaction p = 0.003) and there was a trend toward higher overall carbohydrate oxidation rates in FRU + MD (2.50 ± 0.36 g -1 ·min -1 and 2.31 ± 0.37","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Podlogar', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00082'] 2805,32582829,Comparison of Shear Bond Strength of Three Types of Glass Ionomer Cements Containing Hydroxyapatite Nanoparticles to Deep and Superficial Dentin.,"Statement of the Problem The clinical success of glass ionomer cement (GIC) restorations depends on the strength of its bonding to dentin, yet the bond strength of nanohydroxyapatite (nHAp) added GIC to dentin needs to be investigated. Purpose This study aimed to assess if the type of GIC containing nHAp and dentin depth could affect the shear bond strength (SBS). Materials and Method In this experimental study, 60 freshly extracted intact third molars were randomly divided into two main groups of flat occlusal dentin with different cuts as superficial (S); just below the dentinoenamel junction (DEJ) and deep (D); 2mm below DEJ. After conditioning with 20% polyacrylic acid, each group were randomly assigned to the tested GIC (n=10) subgroups as (1) Fuji IX Extra+nHAp, (2) Fuji II LC+nHAp and (3) Zirconomer+nHAp. Plastic tubes were placed on the pre-treated surfaces and filled with one of the GIC, then stored in an incubator at 37 oC and 100% humidity for 24hr. The specimens were thermocycled at5/55 oC for 500 cycles and subjected to SBS test using a universal testing machine (1 mm/min). The data analyzed by Mann-Whitney and Kruskal-Wallis test ( p < 0.05). Results The means of SBS of Fuji II LC+nHAp was significantly higher than Fuji IX+nHAp and Zirconomer+nHAp both in superficial and deep dentin ( p < 0.05). The means of SBS of Fuji IX Extra+nHAp and Zirconomer+nHAp subgroups in superficial dentin were higher than deep dentin, this differences was statistically significant ( p = 0.0001 and p = 0.009, respectively). Conclusion It can conclude that SBS was influenced by type of GIC and depth of dentin.",2020,The means of SBS of Fuji II LC+nHAp was significantly higher than Fuji IX+nHAp and Zirconomer+nHAp both in superficial and deep dentin ( p < 0.05).,['60 freshly extracted intact third molars'],"['Fuji IX+nHAp and Zirconomer+nHAp', 'Fuji IX Extra+nHAp, (2) Fuji II LC+nHAp and (3) Zirconomer+nHAp', 'flat occlusal dentin with different cuts as superficial (S); just below the dentinoenamel junction (DEJ) and deep (D); 2mm below DEJ', 'glass ionomer cement (GIC) restorations']","['shear bond strength (SBS', 'SBS of Fuji II LC+nHAp']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0288489', 'cui_str': 'Fuji II'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0227020', 'cui_str': 'Dentinoenamel junction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0288489', 'cui_str': 'Fuji II'}]",60.0,0.0236119,The means of SBS of Fuji II LC+nHAp was significantly higher than Fuji IX+nHAp and Zirconomer+nHAp both in superficial and deep dentin ( p < 0.05).,"[{'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Sharafeddin', 'Affiliation': 'Dept. of Operative Dentistry, Biomaterials Research Center, School of Dentistry, Shiraz University of Medial Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Alavi', 'Affiliation': 'Dept. of Operative Dentistry, Biomaterials Research Center, School of Dentistry, Shiraz University of Medial Sciences, Shiraz, Iran.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Siabani', 'Affiliation': 'Postgraduate Student, Dept. of Operative Dentistry, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Safari', 'Affiliation': 'Postgraduate Student, Dept. of Operative Dentistry, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Journal of dentistry (Shiraz, Iran)",['10.30476/DENTJODS.2019.77762.0'] 2806,32583011,Is the fixation of single incision TVT-S tape as good as that of transobturator tape? An ultrasound study of randomized trial results.,"INTRODUCTION TVT-Secur (TVT-S) was the first single-incision sling available on the market and was soon found to have less efficacy than mid-urethral slings. Our aim was to assess the position and tape descent following TVT-O and TVT-S H in a U procedure and, based on this evaluation, to find the possible reason for lower TVT-S surgery efficacy. METHODS We conducted an ultrasound study of a randomised trial with a 3-year follow-up that took place between 2007 and 2009 and included 197 women with urodynamic stress urinary incontinence. Of these, 67 were allocated to receive the TVT-O procedure, 64 to TVT-S in the H position, and 65 in the U position. Patients underwent a complete urogynaecological and ultrasound examination. The positions of the bladder neck and the tape after surgery were assessed and the data obtained compared between groups. RESULTS Our primary study showed a significantly higher rate of positive stress tests in the TVT-S groups compared to the TVT-O group. After surgery, there was no difference between the position of the tape at rest and at maximal Valsalva between the groups. In TVT-O patients, the mean length of the upper tape margin descent increased from 6 mm on the 1st day after surgery to 9 mm 3 months after surgery and remained stable afterwards. For TVT-S patients, there was a further increase of up to 15 mm in tape descent after 3 months. CONCLUSIONS Our results show that the lower efficacy of TVT-S might be due to inadequate fixation and increasing tape descent.",2020,"For TVT-S patients, there was a further increase of up to 15 mm in tape descent after 3 months. ",['2007 and 2009 and included 197 women with urodynamic stress urinary incontinence'],"['TVT-O and TVT-S H', 'TVT-Secur (TVT-S', 'complete urogynaecological and ultrasound examination']","['rate of positive stress tests', 'mean length of the upper tape margin descent']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]",197.0,0.0289558,"For TVT-S patients, there was a further increase of up to 15 mm in tape descent after 3 months. ","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Serdinsek', 'Affiliation': 'Department of General Gynaecology and Urogynaecology, Clinic for Gynaecology and Perinatology, University Medical Centre Maribor, Maribor, Slovenia.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Martan', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Nové Měst, Czech Republic.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Svabik', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Nové Měst, Czech Republic.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'But', 'Affiliation': 'Department of General Gynaecology and Urogynaecology, Clinic for Gynaecology and Perinatology, University Medical Centre Maribor, Maribor, Slovenia.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kolek', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Nové Měst, Czech Republic.'}, {'ForeName': 'Jaromir', 'Initials': 'J', 'LastName': 'Masata', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Nové Měst, Czech Republic. masata@volny.cz.'}]",International urogynecology journal,['10.1007/s00192-020-04390-6'] 2807,32583013,(Lack of) Effects of noradrenergic stimulation on human working memory performance.,"RATIONALE Working memory depends on prefrontal cortex functioning, which is particularly sensitive to levels of noradrenaline. Studies in non-human primates have shown that modest levels of noradrenaline improve working memory, and that higher levels of noradrenaline impair working memory performance. However, research in humans provided inconsistent findings concerning noradrenergic effects on working memory. OBJECTIVE The present study aimed at assessing dose-dependent effects of yohimbine, an alpha-2 adrenoceptor antagonist, on working memory performance in healthy humans. We further aimed to explore a potential interactive effect between noradrenergic arousal and lack of control over aversive events on working memory performance. METHODS We used a double-blind, fully crossed, placebo-controlled, between-subject design. Participants (N = 121) performed an adaptive n-back task before and after oral administration of either a placebo, 20 mg, or 40 mg yohimbine and a manipulation of controllability, during which participants could either learn to avoid electric shocks (controllability groups), had no instrumental control over shock administration (uncontrollability groups), or did not receive any shocks (no-shock control group). RESULTS While no significant results of noradrenergic stimulation through yohimbine were obtained using conventional frequentist analyses, additional Bayesian analyses provided strong evidence for the absence of an association between pharmacological treatment and working memory performance. We further observed no effect of controllability and no interaction between noradrenergic stimulation and the manipulation of controllability. CONCLUSIONS Our results suggest that noradrenergic stimulation through yohimbine does not affect (non-spatial) working memory in healthy human participants.",2020,Our results suggest that noradrenergic stimulation through yohimbine does not affect (non-spatial) working memory in healthy human participants.,"['healthy humans', 'healthy human participants']","['yohimbine', 'placebo, 20\xa0mg, or 40\xa0mg yohimbine and a manipulation of controllability, during which participants could either learn to avoid electric shocks (controllability groups), had no instrumental control over shock administration (uncontrollability groups), or did not receive any shocks (no-shock control group', 'noradrenergic stimulation']","['noradrenergic stimulation', 'human working memory performance']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.15747,Our results suggest that noradrenergic stimulation through yohimbine does not affect (non-spatial) working memory in healthy human participants.,"[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Wanke', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, 20146, Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, 20146, Hamburg, Germany. Lars.Schwabe@uni-hamburg.de.'}]",Psychopharmacology,['10.1007/s00213-020-05590-0'] 2808,32583295,Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.,"BACKGROUND AND OBJECTIVE Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine. METHODS Patients requiring analgesia after bunionectomy or abdominoplasty were randomized to IV demand doses of placebo, oliceridine (0.1 mg, 0.35 mg, or 0.5 mg), or morphine (1 mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5 mg, morphine 4 mg, volume-matched placebo) with a 6-min lockout interval. Certified nurse anesthetists monitored each patient and withheld study medication according to the patient's respiratory status. For each patient, the duration of all DIs was summed and reported as CDDI. A zero-inflated gamma mixture model was used to compute the mean CDDI for each treatment. RESULTS Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%). The CDDI was also lower across all demand doses of oliceridine versus morphine. CONCLUSION Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.",2020,"RESULTS Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","['Patients requiring analgesia after bunionectomy or abdominoplasty', 'Patients Treated for Acute Postoperative Pain']","['Oliceridine and Morphine', 'oliceridine', 'placebo, oliceridine', 'morphine (1\xa0mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5\xa0mg, morphine 4\xa0mg, volume-matched placebo', 'oliceridine and morphine', 'Oliceridine', 'morphine']","['respiratory safety', 'average cumulative duration of DI (CDDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.0289906,"RESULTS Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","[{'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesiology, Cleveland Clinic, Outcomes Research, Anesthesiology Institute, Fairview Hospital, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. Saayad@ccf.org.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burt', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Clinical drug investigation,['10.1007/s40261-020-00936-0'] 2809,32587742,The use of a communication tool about diet at the child health centre: A cluster randomized controlled trial.,"Aim To investigate the effect of a communication tool about diet used in public health nurse consultations with parents compared with standard consultations concerning the 2-year-old child's diet. Design A cluster randomized controlled trial. Methods Ten municipalities were selected randomly and matched in pairs. In each pair, the control or intervention group was randomly allocated. Parents were recruited to participate from January 2015 to January 2017. In intervention clusters, a communication tool about diet was used to help the parents ( N  = 140) to focus on a healthy diet for their child. In the control clusters, parents ( N  = 110) attended standard consultations. The participants completed semi-quantitative food frequency questionnaires at baseline and end point. Results No effect of the intervention was seen on the child's daily intake of vegetables or saturated fat, or body mass index. Significantly fewer parents desired more information about food for toddlers in the intervention than in the control group.",2020,"No effect of the intervention was seen on the child's daily intake of vegetables or saturated fat, or body mass index.","[""public health nurse consultations with parents compared with standard consultations concerning the 2-year-old child's diet"", 'Methods\n\n\nTen municipalities were selected randomly and matched in pairs', 'Parents were recruited to participate from January 2015 to January 2017']",['communication tool about diet'],"[""child's daily intake of vegetables or saturated fat, or body mass index""]","[{'cui': 'C0034022', 'cui_str': 'Public health nurse'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",10.0,0.0469519,"No effect of the intervention was seen on the child's daily intake of vegetables or saturated fat, or body mass index.","[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Holmberg Fagerlund', 'Affiliation': 'Department of Nursing and Health Promotion Faculty of Health Sciences OsloMet - Oslo Metropolitan University Oslo Norway.'}, {'ForeName': 'Sølvi', 'Initials': 'S', 'LastName': 'Helseth', 'Affiliation': 'Department of Nursing and Health Promotion Faculty of Health Sciences OsloMet - Oslo Metropolitan University Oslo Norway.'}, {'ForeName': 'Lene F', 'Initials': 'LF', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition Institute of Basic Medical Sciences Faculty of Medicine University of Oslo Oslo Norway.'}, {'ForeName': 'Milada C', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Department of Nursing and Health Promotion Faculty of Health Sciences OsloMet - Oslo Metropolitan University Oslo Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Glavin', 'Affiliation': 'Department of Health VID Specialized University Oslo Norway.'}]",Nursing open,['10.1002/nop2.498'] 2810,32587748,A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life.,"Background Persons with dementia with mild to moderate cognitive impairment are at risk for developing impairments with activities of daily living such as the ability to feed oneself, that negatively influence health. Lack of caregiver skills related to mealtime planning for persons with dementia and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional status outcomes, lead to weight loss, poor quality of life, and impact their ability to remain at home. Methods A cluster randomized controlled trial with a parallel mixed methods evaluation processes will be conducted to examine the efficacy of a train-the-trainer program using non-paid volunteers in respite care centers to deliver a telehealth mealtime intervention guided by the theory-based C3P Model - Change the Person, Change the People, Change the Place (C3P). In this six-month study, dyads of caregivers and persons with mild to moderate dementia receiving respite care services will be randomized to receive either the telehealth intervention or enhanced usual care. Within the intervention group, dyads will be partnered with a C3P trained volunteer who will work with caregivers via videoconference to devise and implement mealtime plans. Under usual care, dyads will receive standardized educational materials modified from The Savvy Caregiver Program for Alzheimer's disease. The primary outcomes include weight maintenance or gain of the person with dementia and quality of life of the caregiver. A multi-level evaluation process utilizing respite center administrators and directors, volunteers, and caregivers will explore intervention fidelity, acceptability and sustainability. Using both the CONSORT and SPIRIT checklists as guidance, the comprehensive study design is more fully described in this manuscript. Discussion In this trial, we will lay the groundwork to examine the efficacy and sustainability of a train-the-trainer telehealth program that could be widely disseminated by national Alzheimer's organizations and readily adopted by community agencies to provide additional resources to assist families in managing mealtimes at home, while promoting the quality of life of both the caregiver and the person with dementia. Trial registration This study was registered with clinicaltrials.gov: NCT03622814 on August 9, 2018..",2020,"Lack of caregiver skills related to mealtime planning for persons with dementia and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional status outcomes, lead to weight loss, poor quality of life, and impact their ability to remain at home. ","['respite care center volunteers to caregivers of persons with dementia', 'dyads of caregivers and persons with mild to moderate dementia receiving respite care services', 'persons with dementia', 'non-paid volunteers in respite care centers', '\n\n\nPersons with dementia with mild to moderate cognitive impairment']","['telehealth-based train-the-trainer mealtime intervention', 'train-the-trainer program', 'telehealth intervention or enhanced usual care']","['nutritional outcomes and quality of life', 'weight maintenance or gain of the person with dementia and quality of life of the caregiver']","[{'cui': 'C0035247', 'cui_str': 'Respite care of patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C4047892', 'cui_str': 'Respite care service'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.069998,"Lack of caregiver skills related to mealtime planning for persons with dementia and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional status outcomes, lead to weight loss, poor quality of life, and impact their ability to remain at home. ","[{'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Amella Krug', 'Affiliation': 'College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, MSC 160, Charleston, SC 29425-1600 USA.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Qanungo', 'Affiliation': 'College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, MSC 160, Charleston, SC 29425-1600 USA.'}, {'ForeName': 'Kelley L', 'Initials': 'KL', 'LastName': 'Martin', 'Affiliation': 'Digestive Disease Center, Medical University of South Carolina, 5 Charleston Drive, MSC 198, Charleston, SC 29425 USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, MSC 160, Charleston, SC 29425-1600 USA.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Madisetti', 'Affiliation': 'College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, MSC 160, Charleston, SC 29425-1600 USA.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kelechi', 'Affiliation': 'College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas Street, MSC 160, Charleston, SC 29425-1600 USA.'}]",BMC nutrition,['10.1186/s40795-020-00350-x'] 2811,32587752,A randomised controlled pilot trial of two interventions to manage dry mouth in pre-operative elective surgical patients.,"Background Dry mouth is a common perioperative patient complaint. There are a number of treatments used for dry mouth in other settings which are effective. None have been tested previously in the perioperative setting. Interventions to Manage Dry mouth (IM DRY) compared the effect of water and a saliva substitute on mouth dryness. The primary objective was to demonstrate the feasibility of conducting a large randomised controlled trial and secondary scientific aims were to assess treatment potential efficacy. Methods Single blind, pilot randomised controlled trial (RCT) of 101 pre-operative elective surgical patients who were randomised to water or saliva substitute (Biotene oral rinse, GlaxoSmithKline, Australia) at a tertiary, university hospital. Dry mouth was assessed by 100 mm visual analogue scale (VAS) and 5-point Likert score. Results One hundred participants completed follow-up and comprised the analysis dataset. All feasibility outcomes were achieved (recruitment rate > 5 participants a week, >95% completeness of the dataset, study protocol acceptability to staff, acceptability to participants > 66% and adherence to time limits within the protocol). Mean recruitment rate was 6 participants per week. These data were 99% complete. There were no adverse side effects or complications noted. There were no concerns raised by staff regarding acceptability. Overall, there was a mean of 30 min (± SD 5 min) between delivery of the intervention and the assessment, 30 min being the target time. The difference in VAS post intervention was - 11.2 mm (95% CI - 17.3 to - 5.1 mm) for water and - 12.7 mm (95% CI - 18.7 to - 6.7 mm) for saliva substitute. The proportion of patients who had improved dry mouth increased from 52% for water to 62% for saliva substitute. Conclusions IM DRY successfully achieved its primary feasibility aims: recruitment rate, completeness of these, acceptability and protocol adherence. Saliva substitutes, used in the perioperative management of dry mouth, may be a simple, inexpensive, and low risk solution to help alleviate this common complaint. A large randomised controlled trial is feasible and is currently recruiting (ANZCTR 12619000132145). Ethics and Trial registration Northern A New Zealand Health and Disability Ethics Committee (reference 17/NTA/152). Australian New Zealand Clinical Trials Registry (Number: 12618001270202). Registered retrospectively 18 October 2018.",2020,The difference in VAS post intervention was - 11.2 mm (95% CI - 17.3 to - 5.1 mm) for water and - 12.7 mm (95% CI - 18.7 to - 6.7 mm) for saliva substitute.,"['101 pre-operative elective surgical patients', 'pre-operative elective surgical patients', 'One hundred participants completed follow-up and comprised the analysis dataset']","['water or saliva substitute (Biotene oral rinse, GlaxoSmithKline, Australia']","['VAS post intervention', 'Mean recruitment rate', 'mouth dryness', 'dry mouth', 'visual analogue scale (VAS) and 5-point Likert score']","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0673636', 'cui_str': 'Biotene'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.396558,The difference in VAS post intervention was - 11.2 mm (95% CI - 17.3 to - 5.1 mm) for water and - 12.7 mm (95% CI - 18.7 to - 6.7 mm) for saliva substitute.,"[{'ForeName': 'Leesa', 'Initials': 'L', 'LastName': 'Morton', 'Affiliation': 'Department of Anaesthesia, Canterbury District Health Board, 2 Riccarton Avenue, Christchurch Central, Christchurch, 8011 New Zealand.'}, {'ForeName': 'Amanda Tsan Yue', 'Initials': 'ATY', 'LastName': 'Siu', 'Affiliation': 'Department of Anaesthesia, Counties Manukau District Health Board, 100 Hospital Road, Otahuhu, Auckland 2025 New Zealand.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Fowler', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, Level 8, Support Building, Auckland City Hospital, Park Road, Grafton, Auckland 1023 New Zealand.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Anaesthesia, Counties Manukau District Health Board, 100 Hospital Road, Otahuhu, Auckland 2025 New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nixon', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, Level 8, Support Building, Auckland City Hospital, Park Road, Grafton, Auckland 1023 New Zealand.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, Level 8, Support Building, Auckland City Hospital, Park Road, Grafton, Auckland 1023 New Zealand.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00630-0'] 2812,32587757,A Mitomycin C-Sparing Novel Technique for Subscleral Trabeculectomy in Primary Congenital Glaucoma.,"Purpose To evaluate the safety and efficacy of a novel modified subscleral trabeculectomy technique in management of primary congenital glaucoma. Methods This study included 25 infants diagnosed of having bilateral primary congenital glaucoma. For each patient, one eye was assigned to undergo subscleral trabeculectomy with trimming of the edges of the scleral bed (group I), while the contralateral eye underwent subscleral trabeculectomy with application of mitomycin C (0.4 mg/ml for 3 min) (group II). All the patients were followed up for a period of 14 ± 3 months (range 13-22 months). Results 25 eyes were included in each group. Patients' mean age was 2.5 ± 0.5 months (range 1.8-6.5 months). The mean preoperative intraocular pressure was 31 ± 4.9 mmHg and 32.1 ± 4.0 mmHg in group I and II, respectively. The mean postoperative intraocular pressure was 9.0 ± 1.0, 11.0 ± 3.2, 12.5 ± 0.9, 13.0 ± 2.9, and 15.5 ± 1.5 mm Hg in group I and was 10.3 ± 1.2, 12.0 ± 2.5, 13.5 ± 1.7, 15.0 ± 1.5, and 17.1 ± 2.8 mm Hg in group II at the first week and 1, 3, 6, and 12 months, respectively. There was no statistically significant difference between the mean intraocular pressure values recorded at both groups preoperatively and at each follow-up visit. Failure necessitating further surgical interventions was recorded in 4 eyes (16%) in group I as compared to 3 eyes (12%) in group II ( P > 0.05). Postoperative complications included mild hyphema, which occurred in one eye (4%) in group I and 2 eyes (8%) in group II, and shallow anterior chamber in 3 eyes (12%) in group I and in 2 eyes (8%) in group II. One eye (4%) in group I developed drawn-up pupil. Choroidal effusion developed in one eye (4%) at each group. Conclusion Trimming the edges of the scleral bed adjacent to the sclera flap is a safe and effective surgical step which can be added to the subscleral trabeculectomy procedure to effectively control the intraocular pressure in patients with primary congenital glaucoma, sparing them the hazards associated with mitomycin C application.",2020,There was no statistically significant difference between the mean intraocular pressure values recorded at both groups preoperatively and at each follow-up visit.,"['patients with primary congenital glaucoma', 'Primary Congenital Glaucoma', '25 eyes were included in each group', ""Patients' mean age was 2.5\u2009±\u20090.5 months (range 1.8-6.5 months"", '25 infants diagnosed of having bilateral primary congenital glaucoma']","['Mitomycin C-Sparing Novel Technique for Subscleral Trabeculectomy', 'subscleral trabeculectomy with trimming of the edges of the scleral bed', 'subscleral trabeculectomy with application of mitomycin C', 'novel modified subscleral trabeculectomy technique']","['Choroidal effusion', 'Failure necessitating further surgical interventions', 'mild hyphema', 'mean intraocular pressure values', 'safety and efficacy', 'mean postoperative intraocular pressure', 'mean preoperative intraocular pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533041', 'cui_str': 'Primary congenital glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0339434', 'cui_str': 'Choroidal effusion'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020581', 'cui_str': 'Hyphema'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",25.0,0.0248211,There was no statistically significant difference between the mean intraocular pressure values recorded at both groups preoperatively and at each follow-up visit.,"[{'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': ""Bor'i"", 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Salah M', 'Initials': 'SM', 'LastName': 'Al-Mosallamy', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Tamer G', 'Initials': 'TG', 'LastName': 'Elsayed', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Wael M', 'Initials': 'WM', 'LastName': 'El-Haig', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of ophthalmology,['10.1155/2020/2017158'] 2813,32588030,The Sustained Impact of a Medical School-Based Physical Activity Module on Interns' Perceived Competence in Advising Older Adults about Exercise.,"The study aimed to examine the sustained impact of a 1.5-hour medical school-based physical activity (PA) module on interns' perceived competence and importance in advising older adults about exercise. The modified Exercise and Physical Activity Competence Questionnaire (EPACQ) was administered in 2017 (CG: control group) and 2018 (IG: intervention group) two years post-course. The perceived competence of both, CG (n=23) and IG (n=18), decreased significantly over two years (p≤0.05) with no difference between the groups (p>0.05). However, 72.2% (n=13) of the interns who attended the PA module still felt competent in advising older adults about exercise (4.21±0.66) compared to 47.8% (n=11) of the CG (3.89±0.67). The perceived importance decreased significantly in both groups (p≤0.05) with no difference between the groups (p>0.05). However, both groups still perceived exercise for older people as important (CG:4.55±0.61; IG:4.83±0.47). Subsequently, continued professional development is likely to be a key requirement for ensuring sustainability over time.",2020,The perceived importance decreased significantly in both groups (p≤0.05) with no difference between the groups (p>0.05).,['advising older adults about exercise'],"['1.5-hour medical school-based physical activity (PA) module', 'Medical School-Based Physical Activity Module', 'modified Exercise and Physical Activity Competence Questionnaire (EPACQ']",[],"[{'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],,0.0142389,The perceived importance decreased significantly in both groups (p≤0.05) with no difference between the groups (p>0.05).,"[{'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Jadczak', 'Affiliation': 'Agathe Daria Jadczak PhD, Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital DX 465701, 28 Woodville Road, Woodville South, SA 5011, Australia, Phone: +61 8 8133 4012 Email: agathedaria.jadczak@adelaide.edu.au.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Visvanathan', 'Affiliation': ''}]",The Journal of frailty & aging,['10.14283/jfa.2019.39'] 2814,32588034,Effects of High-Speed Power Training on Neuromuscular and Gait Functions in Frail Elderly with Mild Cognitive Impairment Despite Blunted Executive Functions: A Randomized Controlled Trial.,"BACKGROUND Physical frailty and impaired executive function of the brain show similar pathophysiology. Both of these factors lead to dysfunction of neuromuscular and abilities in elderly. High-speed power training (HSPT) has been determined to have positive effects on neuromuscular function and gait performance, as well as executive function in the elderly. OBJECTIVES The purpose of this study was to investigate the effects of 8-week HSPT on neuromuscular, gait and executive functions in frail elderly with mild cognitive impairment (MCI). DESIGN, SETTING AND PARTICIPANTS We performed a randomized controlled trial of frail elderly from community and medical center in republic of Korea. Forty-two physically frail elderly with MCI were randomly allocated to control (n=22, age=74.22±4.46) and intervention groups (n=18, age=73.77±4.64). The intervention group was subjected to HSPT, 3 times weekly for 8 weeks. MEASUREMENTS Isometric contraction of knee extension and flexion with electromyography (EMG) was measured to determine the neuromuscular function such as knee extensor strength, rate of torque development, movement time, pre-motor time, motor time, rate of EMG rise, and hamstrings antagonist co-activation. Additionally, the 4.44-meter gait and timed up-and-go (TUG) test were administered to assess gait performance. A frontal assessment battery was measured in this study. RESULTS The 8-week HSPT regimen improved the knee extensor strength from 1.13±0.08 to 1.25±0.07 (p<0.05), the 200-ms RTD from 3.01±0.3 to 3.55±0.24 (p<0.05) and the rate of EMG rise from 166.48±13.31 to 197.94±11.51 (p<0.05), whereas the movement time and motor time were statistically decreased from 921.69±40.10 to 799.51±72.84, and 271.40±19.29 to 181.15±38.08 (p<0.05), respectively. The 4.44-m gait speed and TUG significantly decreased from 6.39±0.25 to 5.5±0.24, and 11.05±0.53 to 9.17±0.43 respectively (p<0.05). CONCLUSION The findings of this study suggest the favorable effects of 8-week HSPT on the neuromuscular function and the gait performance in the frail elderly with MCI without increase in the executive function.",2020,"The 4.44-m gait speed and TUG significantly decreased from 6.39±0.25 to 5.5±0.24, and 11.05±0.53 to 9.17±0.43 respectively (p<0.05). ","['Forty-two physically frail elderly with MCI', 'frail elderly from community and medical center in republic of Korea', 'frail elderly with mild cognitive impairment (MCI', 'elderly', 'Frail Elderly with Mild Cognitive Impairment']","['High-Speed Power Training', 'HSPT', 'High-speed power training (HSPT']","['neuromuscular function such as knee extensor strength, rate of torque development, movement time, pre-motor time, motor time, rate of EMG rise, and hamstrings antagonist co-activation', 'neuromuscular, gait and executive functions', 'gait performance', 'knee extensor strength', 'executive function', 'Neuromuscular and Gait Functions', 'Isometric contraction of knee extension and flexion with electromyography (EMG', '4.44-m gait speed and TUG', 'movement time and motor time', 'rate of EMG rise', 'neuromuscular function and the gait performance']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",42.0,0.0422568,"The 4.44-m gait speed and TUG significantly decreased from 6.39±0.25 to 5.5±0.24, and 11.05±0.53 to 9.17±0.43 respectively (p<0.05). ","[{'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Prof. Wook Song, Ph.D., Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, 1 Gwanangno, Gwanak-Gu, Seoul 08826, Korea, -mail: songw3@snu.ac.kr, Telephone: 82-2-880-7791, Fax: 82-2-872-2867.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Panday', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ''}]",The Journal of frailty & aging,['10.14283/jfa.2020.23'] 2815,32588042,Computed tomography coronary angiography for patients with heart failure (CTA-HF): a randomized controlled trial (IMAGE-HF 1C).,"AIMS This randomized controlled trial sought to determine the financial impact of an initial diagnostic strategy of coronary computed tomography angiography (CCTA) in patients with heart failure (HF) of unknown aetiology. Invasive coronary angiography (ICA) is used to investigate HF patients. CCTA may be a non-invasive cost-effective alternative to ICA. This randomized controlled trial sought to determine the financial impact of an initial diagnostic strategy of coronary computed tomography angiography (CCTA) in patients with heart failure (HF) of unknown aetiology. METHODS AND RESULTS This multicentre, international trial enrolled patients with HF of unknown aetiology. The primary outcome was the cost of CCTA vs. ICA strategies at 12 months. Clinical outcomes were also collected. An 'intention-to-diagnose' analysis was performed and a secondary 'as-tested' analysis was based on the modality received. Two hundred and forty-six patients were randomized (age = 57.8 ± 11.0 years, ejection fraction = 30.1 ± 10.1%). The severity of coronary artery disease was similar in both groups. In the 121 CCTA patients, 93 avoided ICA. Rates of downstream ischaemia and viability testing were similar for both arms. There were no significant differences in the composite clinical outcomes or quality of life measures. The cost of CCTA trended lower than ICA [CDN -$871 (confidence interval, CI -$4116 to $3028)]. Using an 'as-tested' analysis, CCTA was associated with a decrease in healthcare costs (CDN -$2932, 95% CI -$6248 to $746). CONCLUSION In patients with HF of unknown aetiology, costs were not statistically different between the CCTA and ICA strategies. CLINICAL TRIALS.GOV NCT01283659.",2020,There were no significant differences in the composite clinical outcomes or quality of life measures.,"['patients with heart failure (CTA-HF', 'HF patients', 'international trial enrolled patients with HF of unknown aetiology', '121 CCTA patients, 93 avoided ICA', 'Two hundred and forty-six patients were randomized (age = 57.8\u2009±\u200911.0\u2009years, ejection fraction = 30.1\u2009±\u200910.1', 'patients with heart failure (HF) of unknown aetiology']","['CCTA', 'Invasive coronary angiography (ICA', 'coronary computed tomography angiography (CCTA', 'Computed tomography coronary angiography']","['healthcare costs', 'Rates of downstream ischaemia and viability testing', 'composite clinical outcomes or quality of life measures', 'cost of CCTA vs. ICA strategies', 'cost of CCTA', 'severity of coronary artery disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]",246.0,0.370081,There were no significant differences in the composite clinical outcomes or quality of life measures.,"[{'ForeName': 'Benjamin J W', 'Initials': 'BJW', 'LastName': 'Chow', 'Affiliation': 'Department of Medicine (Cardiology), The University of Ottawa Heart Institute and University of Ottawa, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Coyle', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Alomgir', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': 'Department of Medicine (Cardiology), The University of Ottawa Heart Institute and University of Ottawa, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hanninen', 'Affiliation': 'Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Ukkonen', 'Affiliation': 'Heart Centre and Turku PET Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Rajda', 'Affiliation': 'Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larose', 'Affiliation': 'Laval University, Québec City, Canada.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': 'Heart Centre, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mielniczuk', 'Affiliation': 'Department of Medicine (Cardiology), The University of Ottawa Heart Institute and University of Ottawa, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Kass', 'Affiliation': 'University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Connelly', 'Affiliation': ""Department of Cardiology, Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montréal Heart Institute, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Garrard', 'Affiliation': 'Department of Medicine (Cardiology), The University of Ottawa Heart Institute and University of Ottawa, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bishop', 'Affiliation': 'Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Small', 'Affiliation': 'Department of Medicine (Cardiology), The University of Ottawa Heart Institute and University of Ottawa, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Hedman', 'Affiliation': 'Heart Centre, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Coyle', 'Affiliation': 'Health Economics Research Group, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Yla-Herttuala', 'Affiliation': 'Heart Centre, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Knuuti', 'Affiliation': 'Heart Centre and Turku PET Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Rob S', 'Initials': 'RS', 'LastName': 'Beanlands', 'Affiliation': 'Department of Medicine (Cardiology), The University of Ottawa Heart Institute and University of Ottawa, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jeaa109'] 2816,32588047,A Combined Nutrition and Exercise Intervention Influences Serum Vitamin B-12 and 25-Hydroxyvitamin D and Bone Turnover of Healthy Chinese Middle-Aged and Older Adults.,"BACKGROUND Hong Kong faces several public health problems including malnutrition and osteoporosis. Considering the typical Chinese diet and overall low physical activity levels of Chinese adults, timely interventions to improve nutritional status and bone health are needed. OBJECTIVES We examined the effects of a nutrition plus exercise intervention on serum vitamin B-12 and 25-hydroxyvitamin D [25(OH)D], bone turnover markers, and parathyroid hormone (PTH) concentrations in apparently healthy Chinese middle-aged and older adults. METHODS In this 24-wk randomized controlled trial, 180 Chinese adults (85 women, mean ± SD age: 61 ± 6 y) were randomly assigned to receive a fortified milk supplement (2 × 30 g/d) and an exercise program (2 × 1 h/wk including resistance, balance, and aerobic training) or no intervention. The primary outcome was physical performance. In this article we analyzed the secondary outcomes serum vitamin B-12 and 25(OH)D concentrations, assessed at baseline, 12 wk, and 24 wk. Also, bone turnover markers and PTH concentrations were studied. Linear mixed models evaluated group differences over time. RESULTS A significant time × group interaction (P < 0.001) was found for serum vitamin B-12 and 25(OH)D concentrations and the bone turnover markers, but not for serum PTH concentrations (P = 0.09). The intervention increased mean ± SD vitamin B-12 concentrations from baseline (345 ± 119 pmol/L) to 24 wk (484 ± 136 pmol/L), whereas concentrations remained stable within the control. For 25(OH)D concentrations, the intervention group had a greater increase from baseline (54.7 ± 14.2 nmol/L) to 24 wk (80.1 ± 19.2 nmol/L) than the control (60.6 ± 15.2 compared with 65.6 ± 14.6 nmol/L). The ratio of the net effect of bone formation and resorption was greater in the intervention group, suggesting less bone remodeling, irrespective of sex. CONCLUSIONS A fortified milk supplement and exercise intervention successfully improved vitamin B-12 and 25(OH)D concentrations as well as the balance of bone turnover markers of Chinese middle-aged and older adults.This trial was registered at trialregister.nl as NTR6214.",2020,A fortified milk supplement and exercise intervention successfully improved vitamin B-12 and 25(OH)D concentrations as well as the balance of bone turnover markers of Chinese middle-aged and older adults.,"['Healthy Chinese Middle-Aged and Older Adults', 'SD age: 61\xa0±\xa06 y', 'Chinese middle-aged and older adults', '180 Chinese adults (85 women, mean\xa0±', 'Chinese adults', 'apparently healthy Chinese middle-aged and older adults']","['fortified milk supplement', 'exercise program (2\xa0×\xa01\xa0h/wk including resistance, balance, and aerobic training) or no intervention', 'nutrition plus exercise intervention', 'Combined Nutrition and Exercise Intervention', 'fortified milk supplement and exercise intervention']","['serum vitamin B-12 and 25-hydroxyvitamin D [25(OH)D], bone turnover markers, and parathyroid hormone (PTH) concentrations', 'vitamin B-12 and 25(OH)D concentrations', 'serum vitamin B-12 and 25(OH)D concentrations and the bone turnover markers', 'bone formation and resorption', 'physical performance', 'Serum Vitamin B-12 and 25-Hydroxyvitamin D and Bone Turnover', 'serum PTH concentrations', 'serum vitamin B-12 and 25(OH)D concentrations', 'mean\xa0±\xa0SD vitamin B-12 concentrations', 'bone turnover markers and PTH concentrations']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",180.0,0.0580461,A fortified milk supplement and exercise intervention successfully improved vitamin B-12 and 25(OH)D concentrations as well as the balance of bone turnover markers of Chinese middle-aged and older adults.,"[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groenendijk', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sherlin', 'Initials': 'S', 'LastName': 'Ong', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Panam', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Marjolijn Ce', 'Initials': 'MC', 'LastName': 'Bragt', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Lisette Cpgm', 'Initials': 'LC', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxaa149'] 2817,32588050,"Sodium zirconium cyclosilicate increases serum bicarbonate concentrations among patients with hyperkalaemia: exploratory analyses from three randomized, multi-dose, placebo-controlled trials.","BACKGROUND Sodium zirconium cyclosilicate (SZC) binds potassium and ammonium in the gastrointestinal tract. In addition to serum potassium reduction, Phase 2 trial data have shown increased serum bicarbonate with SZC, which may be clinically beneficial because maintaining serum bicarbonate ≥22 mmol/L preserves kidney function. This exploratory analysis examined serum bicarbonate and urea, and urine pH data from three SZC randomized, placebo-controlled Phase 3 studies among patients with hyperkalaemia [ZS-003 (n = 753), HARMONIZE (n = 258) and HARMONIZE-Global (n = 267)]. METHODS In all studies, patients received ≤10 g SZC 3 times daily (TID) for 48 h to correct hyperkalaemia, followed by randomization to maintenance therapy with SZC once daily (QD) versus placebo for ≤29 days among those achieving normokalaemia. RESULTS Significant dose-dependent mean serum bicarbonate increases from baseline of 0.3 to 1.5 mmol/L occurred within 48 h of SZC TID in ZS-003 (all P < 0.05), which occurred regardless of chronic kidney disease (CKD) stage. Similar acute increases in HARMONIZE and HARMONIZE-Global were maintained over 29 days. With highest SZC maintenance doses, patient proportions with serum bicarbonate <22 mmol/L fell from 39.4% at baseline to 4.9% at 29 days (P = 0.005) in HARMONIZE and from 87.9% to 70.1%, (P = 0.006) in HARMONIZE-Global. Path analyses demonstrated that serum urea decreases (but not serum potassium or urine pH changes) were associated with SZC effects on serum bicarbonate. CONCLUSIONS SZC increased serum bicarbonate concentrations and reduced patient proportions with serum bicarbonate <22 mmol/L, likely due to SZC-binding of gastrointestinal ammonium. These SZC-induced serum bicarbonate increases occurred regardless of CKD stage and were sustained during ongoing maintenance therapy.",2020,"Path analyses demonstrated that serum urea decreases (but not serum potassium or urine pH changes) were associated with SZC effects on serum bicarbonate. ","['patients with hyperkalaemia', 'patients with hyperkalaemia ']","['Sodium zirconium cyclosilicate (SZC', 'SZC once daily (QD) versus placebo', 'ZS-003', 'Sodium zirconium cyclosilicate', 'placebo']","['serum bicarbonate and urea, and urine pH data', 'mean serum bicarbonate', 'serum urea decreases', 'serum bicarbonate concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}]","[{'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0042044', 'cui_str': 'Urine pH test'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0857446', 'cui_str': 'Serum urea decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.109333,"Path analyses demonstrated that serum urea decreases (but not serum potassium or urine pH changes) were associated with SZC effects on serum bicarbonate. ","[{'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Roger', 'Affiliation': 'Renal Research, Gosford, Australia.'}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Spinowitz', 'Affiliation': 'Division of Nephrology, Department of Medicine, New York-Presbyterian Queens, New York, NY, USA.'}, {'ForeName': 'Edgar V', 'Initials': 'EV', 'LastName': 'Lerma', 'Affiliation': 'Section of Nephrology, Advocate Christ Medical Center, University of Illinois at Chicago, Oak Lawn, IL, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Ash', 'Affiliation': 'HemoCleanse Technologies, LLC and Ash Access Technology, Inc, Lafayette, IN, USA.'}, {'ForeName': 'Julian G', 'Initials': 'JG', 'LastName': 'Martins', 'Affiliation': 'inScience Communications, Springer Healthcare, Paris, France.'}, {'ForeName': 'Carol Moreno', 'Initials': 'CM', 'LastName': 'Quinn', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Packham', 'Affiliation': 'Melbourne Renal Research Group, Reservoir Private Hospital, Reservoir, Australia.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa158'] 2818,32588228,Tech Connect: An Intervention to Promote Treatment Engagement for Adolescents with Depression.,"Poor treatment engagement remains a challenge in effectively treating adolescents with depression. This exploratory 2-arm RCT aimed to test the feasibility and acceptability of Tech Connect for promoting treatment engagement among adolescents. Twenty youth with depression were randomized to Tech Connect (treatment) or standard community-based mental health care (control). Study aims included: (1) assess the feasibility and acceptability of Tech Connect between-session contacts for adolescents, their parents, and treatment providers and (2) conduct a preliminary analysis of engagement and mental health outcomes. Significant differences were found between the number of treatment sessions attended by the Tech Connect and control group (t = 2.00; p < .05). Adolescents receiving Tech Connect attended 91.3% (mean = 7.5 sessions; SD = 1.58) of their initial eight sessions, while 66.3% (mean = 5.3 sessions; SD = 3.09) attended in the control condition. Tech Connect is a novel, technologically-driven intervention that proved effective in improving treatment engagement among adolescents with depression.",2020,Significant differences were found between the number of treatment sessions attended by the Tech Connect and control group (t = 2.00; p < .05).,"['Adolescents with Depression', 'Twenty youth with depression', 'adolescents with depression', 'adolescents']",['Tech Connect (treatment) or standard community-based mental health care (control'],['feasibility and acceptability of Tech Connect'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0275436,Significant differences were found between the number of treatment sessions attended by the Tech Connect and control group (t = 2.00; p < .05).,"[{'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Gearing', 'Affiliation': 'Center for Mental Health Research and Innovation in Treatment Engagement and Service (MH-RITES Research Center), Graduate College of Social Work, University of Houston, 3511 Cullen Boulevard, 110HA, Houston, TX, 77204, USA. rgearing@uh.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Attia-Guetta', 'Affiliation': ', Tel-Aviv, Israel.'}, {'ForeName': 'Kiara', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Silver School of Social Work, New York University, 1 Washington Square North, New York, NY, 10003, USA.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Gorroochurn', 'Affiliation': 'R620 Department of Biostatistics, Columbia University, 722 W 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Lindamarie', 'Initials': 'L', 'LastName': 'Olson', 'Affiliation': 'Graduate College of Social Work, University of Houston, 3511 Cullen Boulevard, Houston, TX, 77204, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Malekoff', 'Affiliation': 'North Shore Child and Family Guidance Center, 480 Old Westbury Road, Roslyn Heights, NY, 11577, USA.'}]",Community mental health journal,['10.1007/s10597-020-00663-y'] 2819,32588238,Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation.,"PURPOSE Determining the optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important clinical issue. We evaluated the effects of ischemia (by DAPT score) and bleeding (by PRECISE-DAPT score), as well as the impact of DAPT duration, on clinical outcomes. METHODS From pooled analysis of four randomized clinical trials, 5131 patients undergoing second-generation DES implantation were randomized to short-duration (n = 2575; ≤ 6 months) or standard-duration (n = 2556; ≥ 12 months) DAPT groups. This population was further divided into four subgroups according to PRECISE-DAPT (high bleeding risk ≥ 25) and DAPT (high ischemic risk ≥ 2) scores. RESULTS Net clinical outcomes (1.3% vs. 1.3%; p = 0.89) and ischemic events (5.0% vs. 4.5%; p = 0.44) did not differ between the two duration groups, although bleeding events were more frequent in patients with standard-duration DAPT (0.4% vs. 0.9%; p = 0.04). Standard-duration DAPT was associated with fewer ischemic events (6.9% vs. 4.0%; p = 0.02) and no increase in bleeding events only among patients at low bleeding risk and high ischemic risk. The other groups show no differences in net clinical outcomes, ischemic events, or bleeding events according to DAPT duration. CONCLUSION Compared with short-duration DAPT, standard-duration DAPT was associated with similar net clinical outcomes and ischemic events, but more bleeding events at 12 months after second-generation DES implantation. However, standard-duration DAPT reduced ischemic events without increasing bleeding events among patients at low bleeding and high ischemic risk. When determining DAPT duration, considering both ischemic and bleeding risk can help optimize patient benefits. CLINICAL TRIAL REGISTRATION EXCELLENT (NCT00698607), RESET (NCT01145079), IVUS-XPL (NCT01308281), OPTIMA-C (NCT03056118).",2020,"Compared with short-duration DAPT, standard-duration DAPT was associated with similar net clinical outcomes and ischemic events, but more bleeding events at 12 months after second-generation DES implantation.",['5131 patients undergoing second-generation DES implantation'],['dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation'],"['bleeding events', 'net clinical outcomes, ischemic events, or bleeding events', 'ischemia (by DAPT score) and bleeding', 'ischemic events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5131.0,0.0305431,"Compared with short-duration DAPT, standard-duration DAPT was associated with similar net clinical outcomes and ischemic events, but more bleeding events at 12 months after second-generation DES implantation.","[{'ForeName': 'Ji-Yong', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'National Health Insurance Service Ilsan Hospital, Goyang, South Korea.'}, {'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Jung', 'Affiliation': 'Daegu Catholic University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Byoung-Kwon', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul, 135-720, South Korea. cardiobk@yuhs.ac.'}, {'ForeName': 'Dong-Ho', 'Initials': 'DH', 'LastName': 'Shin', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. kjs1218@yuhs.ac.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Kyung Woo', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Seoul National University Hospital School of Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital School of Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyuck Moon', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul, 135-720, South Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07008-7'] 2820,32588274,A theory-based intervention to promote medication adherence in patients with rheumatoid arthritis: A randomized controlled trial.,"INTRODUCTION/OBJECTIVES Adherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important that interventions are developed to address this important health behavior issue. The aim of the present study was to design and evaluate a theory-based intervention to improve the medication adherence (primary outcome) among rheumatoid arthritis patients. METHODS The study adopted a pre-registered randomized controlled trial design. Rheumatoid arthritis patients were recruited from two University teaching hospitals in Qazvin, Iran from June 2018 to May 2019 and randomly assigned to either an intervention group (n = 100) or a treatment-as-usual group (n = 100). The intervention group received a theory-based intervention designed based on the theoretical underpinnings of the health action process approach (HAPA). More specifically, action planning (making detailed plans to follow medication regimen), coping planning (constructing plans to overcome potential obstacles that may arise in medication adherence), and self-monitoring (using a calendar to record medication adherence) of the HAPA has been used for the treatment. The treatment-as-usual group received standard care. RESULTS Data analysis was conducted based on the principle of intention to treat. Using a linear mixed-effects model (adjusted for age, sex, medication prescribed, and body mass index), the results showed improved medication adherence scores in the intervention group (loss to follow-up = 16) compared to the treatment-as-usual group (loss to follow-up = 12) at the 3-month (coefficient = 3.9; SE = 0.8) and 6-month (coefficient = 4.5; SE = 0.8) follow-up. Intervention effects on medication adherence scores were found to be mediated by some of the theory-based HAPA variables that guided the study. CONCLUSION The results of the present study support the use of a theory-based intervention for improving medication adherence among rheumatoid arthritis patients, a group at-risk of not adhering to medication regimens. TRIAL REGISTRATION (IN IRANIAN REGISTRY OF CLINICAL TRIALS): irct.ir, IRCT20180108038271N1Key Points• Theoretical underpinnings of the health action process approach are useful to improve medication adherence for RA patients.",2020,"Intervention effects on medication adherence scores were found to be mediated by some of the theory-based HAPA variables that guided the study. ","['patients with rheumatoid arthritis', 'RA patients', 'Rheumatoid arthritis patients were recruited from two University teaching hospitals in Qazvin, Iran from June 2018 to May 2019', 'rheumatoid arthritis patients']","['theory-based intervention designed based on the theoretical underpinnings of the health action process approach (HAPA', 'theory-based intervention', 'standard care', 'intervention group (n\u2009=\u2009100) or a treatment-as-usual group']","['medication adherence scores', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0480508,"Intervention effects on medication adherence scores were found to be mediated by some of the theory-based HAPA variables that guided the study. ","[{'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Abbasi', 'Affiliation': 'Metabolic Disease Research Center, Research Institute for Prevention of Non-communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Yu-Pin', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedic Surgery, Wan Fang Hospital, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'Psychology Department, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. cylin36933@gmail.com.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahounar BLV, Qazvin, 3419759811, Iran. pakpour_amir@yahoo.com.'}]",Clinical rheumatology,['10.1007/s10067-020-05224-y'] 2821,32588401,Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial.,"BACKGROUND Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, improved wakefulness and reduced excessive daytime sleepiness (EDS) in studies of participants with narcolepsy with and without cataplexy. OBJECTIVE Prespecified subgroup analyses of data from a 12-week randomized, double-blind, placebo-controlled, phase III trial of solriamfetol for EDS in narcolepsy evaluated the efficacy and safety of solriamfetol by cataplexy status. METHODS Participants with narcolepsy received solriamfetol (75, 150, or 300 mg/day) or placebo and were stratified by cataplexy status. Coprimary endpoints were change from baseline on Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS); Patient Global Impression of Change (PGI-C) was the key secondary endpoint. Change in frequency of cataplexy attacks was evaluated in participants reporting cataplexy at baseline. Safety was evaluated. No adjustments were made for multiple comparisons; therefore p values are nominal. RESULTS There were 117 participants in the cataplexy subgroup and 114 in the non-cataplexy subgroup. At week 12, least-squares (LS) mean (95% confidence interval [CI]) differences from placebo on change from baseline in MWT for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup were 1.6 (- 3.6 to 6.9), 6.1 (0.7-11.4), and 8.9 (3.5-14.2) minutes, respectively (p < 0.05; 150 and 300 mg), and in the non-cataplexy subgroup were 3.4 (- 1.9 to 8.7), 9.1 (3.8-14.3), and 11.2 (5.8-16.6) minutes, respectively (p < 0.001; 150 and 300 mg). At week 12, LS mean (95% CI) differences from placebo on ESS change from baseline for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup were - 1.3 (- 3.9 to 1.3), - 3.7 (- 6.4 to - 1.1), and - 4.5 (- 7.1 to - 1.9), respectively (p < 0.01; 150 and 300 mg), and in the non-cataplexy subgroup were - 3.0 (- 5.6 to - 0.4), - 3.7 (- 6.3 to - 1.2), and - 4.9 (- 7.6 to - 2.2), respectively (p < 0.05; all doses). For PGI-C at week 12, the mean percentage difference from placebo (95% CI) for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup was 10% (- 15 to 35), 33% (9-57), and 39% (16-61), respectively (p < 0.05; 150 and 300 mg), and in the non-cataplexy subgroup was 48% (25-70), 44% (21-67), and 52% (30-73), respectively (p < 0.001; all doses), with somewhat differential treatment effects for 75 mg by cataplexy status. No changes in the number of cataplexy attacks were observed for solriamfetol compared with placebo (mean ± standard deviation changes: - 3.6 ± 13.3 [combined solriamfetol] and - 3.5 ± 9.8 [placebo]). Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups. CONCLUSIONS These data strongly indicate that solriamfetol was effective in treating EDS in participants with narcolepsy with or without cataplexy, as indicated by robust effects on MWT, ESS, and PGI-C. The safety profile was similar regardless of cataplexy status. TRIAL REGISTRATION AND DATE ClinicalTrials.gov NCT02348593. 28 January 2015.",2020,"Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups. ","['117 participants in the cataplexy subgroup and 114 in the non-cataplexy subgroup', 'participants with narcolepsy with and without cataplexy', 'Participants with Narcolepsy with and without Cataplexy', 'Participants with narcolepsy received solriamfetol (75, 150, or 300\xa0mg/day) or', 'participants with narcolepsy with or without cataplexy', '28 January 2015']",['placebo'],"['Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis', 'number of cataplexy attacks', 'Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS); Patient Global Impression of Change (PGI-C', 'excessive daytime sleepiness (EDS', 'ESS change', 'Excessive Daytime Sleepiness', 'frequency of cataplexy attacks']","[{'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0303405', 'cui_str': 'Indium-114'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C4726765', 'cui_str': 'Solriamfetol'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.426224,"Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups. ","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Département de Neurologie, Centre National de Référence Narcolepsie Hypersomnies Inserm U1061, CHU Gui-de-Chauliac, University of Montpellier, 80, Avenue Augustin Fliche, 34295, Montpellier Cedex 5, France. y-dauvilliers@chu-montpellier.fr.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Shapiro', 'Affiliation': 'UHN-Toronto Western Hospital, University of Toronto, 399 Bathurst St, MP7, 421, Medical Sciences, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Mayer', 'Affiliation': 'Hephata Klinik, Schimmelpfengstraße 6, 34613, Schwalmstadt, Germany.'}, {'ForeName': 'Gert Jan', 'Initials': 'GJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Emsellem', 'Affiliation': 'The Center for Sleep and Wake Disorders, 5454 Wisconsin Ave, Suite 1725, Chevy Chase, MD, 20815, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thorpy', 'Affiliation': 'Montefiore Medical Center, 111 East 210th Street, Bronx, NY, 10467-2509, USA.'}]",CNS drugs,['10.1007/s40263-020-00744-2'] 2822,32588418,Hydrosonographic Assessment of the Effect of Two Different Suture Materials on Healing of the Uterine Scar after Cesarean Delivery: A Prospective Randomized Controlled Trial.,"PURPOSE This study aimed to compare the effects of two different suture materials, monofilament synthetic absorbable sutures versus multifilament synthetic absorbable sutures, on healing the uterine scar after a cesarean delivery. METHODS A total of 95 women between the ages of 18 and 40 who had undergone a primary cesarean section (CS) after the 38 th week of gestation. In Group I (n=48), continuous double-layer unlocked closure of the low transverse uterine incision was performed using monofilament synthetic absorbable sutures. In Group II (n=47), continuous double-layer unlocked closure of the low transverse uterine incision was performed using multifilament synthetic absorbable sutures. Six months after the operation, the integrity of the cesarean scar at the uterine incision site was assessed using hydrosonography. The healing ratio and the thickness of the residual myometrium covering the defect were calculated as markers of uterine scar healing. RESULTS No statistically significant differences were observed between the groups with regard to the preoperative hemoglobin concentrations, the change in the hemoglobin concentrations, operating time, and the number of intraoperative additional hemostatic uterine sutures. Mean thickness of the residual myometrium covering the defect was thicker in the monofilament suture group in comparison to the multifilament suture group (7.76±2.11 vs. 5.96±1.69, respectively; p<0.01). The mean healing ratio was significantly higher in the monofilament suture group in comparison to the multifilament suture group (0.76±0.13 vs. 0.60±0.12, respectively; p<0.01) CONCLUSION: Continuous double-layer unlocked closure of the uterine incision at cesarean delivery using monofilament synthetic absorbable sutures decreases the risk of CS scar defect.",2020,"The mean healing ratio was significantly higher in the monofilament suture group in comparison to the multifilament suture group (0.76±0.13 vs. 0.60±0.12, respectively; p<0.01) CONCLUSION:","['after Cesarean Delivery', '95 women between the ages of 18 and 40 who had undergone a primary cesarean section (CS) after the 38 th week of gestation']","['suture materials, monofilament synthetic absorbable sutures versus multifilament synthetic absorbable sutures', 'Two Different Suture Materials', 'continuous double-layer unlocked closure of the low transverse uterine incision', 'monofilament synthetic absorbable sutures', 'monofilament suture', 'continuous double-layer unlocked closure of the low transverse uterine incision was performed using multifilament synthetic absorbable sutures']","['hemoglobin concentrations, operating time, and the number of intraoperative additional hemostatic uterine sutures', 'mean healing ratio', 'Mean thickness of the residual myometrium covering the defect', 'risk of CS scar defect', 'integrity of the cesarean scar', 'preoperative hemoglobin concentrations', 'Healing of the Uterine Scar', 'healing ratio and the thickness of the residual myometrium']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0038969', 'cui_str': 'Surgical suture'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1961537', 'cui_str': 'Monofilament suture'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0027088', 'cui_str': 'Myometrial structure'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}]",95.0,0.0512276,"The mean healing ratio was significantly higher in the monofilament suture group in comparison to the multifilament suture group (0.76±0.13 vs. 0.60±0.12, respectively; p<0.01) CONCLUSION:","[{'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Sevket', 'Affiliation': 'Obstetrics and gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Takmaz', 'Affiliation': 'Obstetrics and gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Ozcan', 'Affiliation': 'Obstetrics and gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Belfin Nur Arici', 'Initials': 'BNA', 'LastName': 'Halici', 'Affiliation': 'Obstetrics and gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Sevde Havva', 'Initials': 'SH', 'LastName': 'Islek', 'Affiliation': 'Obstetrics and gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-1179-1393'] 2823,32588435,Ketogenic diets for drug-resistant epilepsy.,"BACKGROUND Ketogenic diets (KDs) are high in fat and low in carbohydrates and have been suggested to reduce seizure frequency in people with epilepsy. Such diets may be beneficial for children with drug-resistant epilepsy. This is an update of a review first published in 2003, and last updated in 2018. OBJECTIVES To assess the effects of ketogenic diets for people with drug-resistant epilepsy. SEARCH METHODS For this update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 26 April 2019) on 29 April 2019. The Cochrane Register of Studies includes the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), and randomised controlled trials (RCTs) from Embase, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions. We checked the reference lists of retrieved studies for additional relevant studies. SELECTION CRITERIA RCTs or quasi-RCTs of KDs for people of any age with drug-resistant epilepsy. DATA COLLECTION AND ANALYSIS Two review authors independently applied predefined criteria to extract data and evaluated study quality. We assessed the outcomes: seizure freedom, seizure reduction (50% or greater reduction in seizure frequency), adverse effects, cognition and behaviour, quality of life, and attrition rate. We incorporated a meta-analysis. We utilised an intention-to-treat (ITT) population for all primary analyses. We presented the results as risk ratios (RRs) with 95% confidence intervals (CIs). MAIN RESULTS We identified 13 studies with 932 participants; 711 children (4 months to 18 years) and 221 adults (16 years and over). We assessed all 13 studies to be at high risk of performance and detection bias, due to lack of blinding. Assessments varied from low to high risk of bias for all other domains. We rated the evidence for all outcomes as low to very low certainty. Ketogenic diets versus usual care for children Seizure freedom (RR 3.16, 95% CI 1.20 to 8.35; P = 0.02; 4 studies, 385 participants; very low-certainty evidence) and seizure reduction (RR 5.80, 95% CI 3.48 to 9.65; P < 0.001; 4 studies, 385 participants; low-certainty evidence) favoured KDs (including: classic KD, medium-chain triglyceride (MCT) KD combined, MCT KD only, simplified modified Atkins diet (MAD) compared to usual care for children. We are not confident that these estimated effects are accurate. The most commonly reported adverse effects were vomiting, constipation and diarrhoea for both the intervention and usual care group, but the true effect could be substantially different (low-certainty evidence). Ketogenic diet versus usual care for adults In adults, no participants experienced seizure freedom. Seizure reduction favoured KDs (MAD only) over usual care but, again, we are not confident that the effect estimated is accurate (RR 5.03, 95% CI 0.26 to 97.68; P = 0.29; 2 studies, 141 participants; very low-certainty evidence). Adults receiving MAD most commonly reported vomiting, constipation and diarrhoea (very low-certainty evidence). One study reported a reduction in body mass index (BMI) plus increased cholesterol in the MAD group. The other reported weight loss. The true effect could be substantially different to that reported. Ketogenic diet versus ketogenic diet for children Up to 55% of children achieved seizure freedom with a classical 4:1 KD after three months whilst up to 85% of children achieved seizure reduction (very low-certainty evidence). One trial reported a greater incidence of seizure reduction with gradual-onset KD, as opposed to fasting-onset KD. Up to 25% of children were seizure free with MAD and up to 60% achieved seizure reduction. Up to 25% of children became seizure free with MAD and up to 60% experienced seizure reduction. One study used a simplified MAD (sMAD) and reported that 15% of children gained seizure freedom rates and 56% achieved seizure reduction. We judged all the evidence described as very low certainty, thus we are very unsure whether the results are accurate. The most commonly reported adverse effects were vomiting, constipation and diarrhoea (5 studies, very low-certainty evidence). Two studies reported weight loss. One stated that weight loss and gastrointestinal disturbances were more frequent, with 4:1 versus 3:1 KD, whilst one reported no difference in weight loss with 20 mg/d versus 10 mg/d carbohydrates. In one study, there was a higher incidence of hypercalcuria amongst children receiving classic KD compared to MAD. All effects described are unlikely to be accurate. Ketogenic diet versus ketogenic diet for adults One study randomised 80 adults (aged 18 years and over) to either MAD plus KetoCal during the first month with MAD alone for the second month, or MAD alone for the first month followed by MAD plus KetoCal for the second month. No adults achieved seizure freedom. More adults achieved seizure reduction at one month with MAD alone (42.5%) compared to MAD plus KetoCal (32.5%), however, by three months only 10% of adults in both groups maintained seizure reduction. The evidence for both outcomes was of very low certainty; we are very uncertain whether the effects are accurate. Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence). Diarrhoea and increase/change in seizure pattern/semiology were also commonly reported (17.5% to 20% of participants). The true effects of the diets could be substantially different to that reported. AUTHORS' CONCLUSIONS The evidence suggests that KDs could demonstrate effectiveness in children with drug-resistant epilepsy, however, the evidence for the use of KDs in adults remains uncertain. We identified a limited number of studies which all had small sample sizes. Due to the associated risk of bias and imprecision caused by small study populations, the evidence for the use of KDs was of low to very low certainty. More palatable but related diets, such as the MAD, may have a similar effect on seizure control as the classical KD, but could be associated with fewer adverse effects. This assumption requires more investigation. For people who have drug-resistant epilepsy or who are unsuitable for surgical intervention, KDs remain a valid option. Further research is required, particularly for adults with drug-resistant epilepsy.",2020,"Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence).","['932 participants; 711 children (4 months to 18 years) and 221 adults (16 years and over', 'children with drug-resistant epilepsy', 'people of any age with drug-resistant epilepsy', '1946 to 26 April 2019) on 29 April 2019', 'people with epilepsy', 'adults with drug-resistant epilepsy', 'For people who have drug-resistant epilepsy or who are unsuitable for surgical intervention, KDs remain a valid option', 'adults One study randomised 80 adults (aged 18 years and over) to either', 'adults', 'Adults receiving', 'people with drug-resistant epilepsy']","['Ketogenic diets', 'Ketogenic diet versus usual care', 'Ketogenic diet versus ketogenic diet', 'ketogenic diets', 'simplified MAD (sMAD', 'MAD plus KetoCal', 'Ketogenic diets versus usual care', 'MAD']","['seizure frequency), adverse effects, cognition and behaviour, quality of life, and attrition rate', 'seizure freedom rates', 'Diarrhoea', 'body mass index (BMI) plus increased cholesterol', 'seizure free with MAD', 'Constipation', 'outcomes: seizure freedom, seizure reduction', 'vomiting, constipation and diarrhoea', 'weight loss', 'weight loss and gastrointestinal disturbances', 'seizure pattern/semiology', 'seizure reduction', 'seizure freedom']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0232459', 'cui_str': 'Abnormal digestive tract function'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",80.0,0.178047,"Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence).","[{'ForeName': 'Kirsty J', 'Initials': 'KJ', 'LastName': 'Martin-McGill', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bresnahan', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Levy', 'Affiliation': 'The Croft Shifta Health Centre, Rochdale, UK.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Cooper', 'Affiliation': 'Centre for Clinical Neurosciences, Salford Royal Hospitals NHS Trust, Salford, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001903.pub5'] 2824,32588515,Biochemical control of the combination of cyclooxygenase-2 inhibitor and 125 I-brachytherapy for prostate cancer: Post hoc analysis of an open-label controlled randomized trial.,"OBJECTIVES To evaluate the use of cyclooxygenase-2 inhibitors in patients receiving low-dose-rate brachytherapy for prostate cancer. METHODS A total of 310 patients with prostate cancer (cT1c-3aN0M0) who received low-dose-rate brachytherapy between May 2010 and July 2013 were enrolled and allocated to one of the two treatment groups (tamsulosin alone 0.2 mg/day for 6 months vs tamsulosin 0.2 mg/day for 6 months plus celecoxib 200 mg/day for 3 months). The primary end-point was the chronological change in international prostate symptom score, and the number of patients was assessed for the primary end-point. Biochemical recurrence-free, cancer-specific survival and overall survival rates 5 years after the last patient received low-dose-rate brachytherapy were retrospectively examined. RESULTS The median follow-up period after low-dose-rate brachytherapy was 72.0 months (range 3-99 months). A total of 12 (3.9%) patients experienced biochemical recurrence. The biochemical recurrence-free rate in the celecoxib group (5-year biochemical recurrence-free rate 98.5%) was significantly better (log-rank test P = 0.023, 95% confidence interval 0.07-0.63, hazard ratio 0.20) than that in the tamsulosin group (5-year biochemical recurrence-free rate 93.4%). None of the patients died from prostate cancer. However, 14 (4.5%) patients died of other causes. No significant difference was observed in terms of overall survival between the celecoxib and tamsulosin groups. CONCLUSIONS The combination of cyclooxygenase-2 inhibitor and low-dose-rate brachytherapy can contribute to a better biochemical control of prostate cancer.",2020,"Biochemical recurrence-free, cancer-specific survival and overall survival rates","['patients receiving low-dose-rate brachytherapy for prostate cancer', '310 patients with prostate cancer (cT1c-3aN0M0) who received low-dose-rate brachytherapy between May 2010 and July 2013', 'prostate cancer']","['tamsulosin', 'cyclooxygenase-2 inhibitors', 'low-dose-rate brachytherapy', 'cyclooxygenase-2 inhibitor and low-dose-rate brachytherapy', 'cyclooxygenase-2 inhibitor and 125 I-brachytherapy', 'tamsulosin alone 0.2\xa0mg/day for 6\xa0months vs tamsulosin 0.2\xa0mg/day for 6\xa0months plus celecoxib', 'celecoxib']","['biochemical recurrence', 'overall survival', 'biochemical recurrence-free rate', 'chronological change in international prostate symptom score', 'Biochemical recurrence-free, cancer-specific survival and overall survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C5191352', 'cui_str': '310'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",310.0,0.124329,"Biochemical recurrence-free, cancer-specific survival and overall survival rates","[{'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Asakawa', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Anai', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Makito', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Morizawa', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Shunta', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Owari', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of, Diagnostic Pathology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Ohbayashi', 'Affiliation': 'Department of, Diagnostic Pathology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yamaki', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Hasegawa', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14294'] 2825,32588653,The Efficacy of a Single Session of 20-Minute Mindful Breathing in Reducing Dyspnea Among Patients With Acute Decompensated Heart Failure: A Randomized Controlled Trial.,"Heart failure is the leading cause of morbidity and mortality worldwide. Standard treatment for heart failure includes pharmacotherapy and cardiac device implants. However, supportive approaches in managing dyspnea in heart failure are limited. This study aimed to test the efficacy of 20-minute mindful breathing in reducing dyspnea among patients admitted for acute decompensated heart failure. We conducted a parallel-group, non-blinded, randomized controlled trial of a single session of 20-minute mindful breathing plus standard care versus standard care alone among patients admitted for moderate to severe dyspnea due to acute decompensated heart failure, using the dyspnea score based on the Edmonton Symptom Assessment System (ESAS), at the Cardiology Unit of University Malaya Medical Centre in Malaysia. Thirty participants were randomly assigned to a single session of 20-minute mindful breathing plus standard care (n = 15) or standard care alone (n = 15), with no difference in their demographic and clinical characteristics. There was statistically significant reduction in dyspnea in the intervention group compared to the control group at minute 20 (U = 49.5, n 1 = 15, n 2 =15, median reduction in ESAS dyspnea score 1 = 2, median reduction in ESAS dyspnea score 2 = 0, mean rank 1 = 11.30, mean rank 2 = 19.70, z = -2.692, r = 0.4, P = 0.007). Our results provided evidence that a single session of 20-minute mindful breathing was efficacious in reducing dyspnea for patients admitted for acute decompensated heart failure.",2020,"There was statistically significant reduction in dyspnea in the intervention group compared to the control group at minute 20 (U = 49.5, n 1 = 15, n 2 =15, median reduction in ESAS dyspnea score 1 = 2, median reduction in ESAS dyspnea score 2 = 0, mean rank 1 = 11.30, mean rank 2 = 19.70, z = -2.692, r = 0.4, P = 0.007).","['patients admitted for acute decompensated heart failure', 'patients admitted for moderate to severe dyspnea due to acute decompensated heart failure, using the dyspnea score based on the Edmonton Symptom Assessment System (ESAS), at the Cardiology Unit of University Malaya Medical Centre in Malaysia', 'Patients With Acute Decompensated Heart Failure', 'heart failure includes pharmacotherapy and cardiac device implants', 'Thirty participants']","['20-minute mindful breathing plus standard care versus standard care alone', '20-minute mindful breathing plus standard care (n = 15) or standard care alone', '20-minute mindful breathing', '20-Minute Mindful Breathing']","['ESAS dyspnea score', 'Dyspnea', 'dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0636211,"There was statistically significant reduction in dyspnea in the intervention group compared to the control group at minute 20 (U = 49.5, n 1 = 15, n 2 =15, median reduction in ESAS dyspnea score 1 = 2, median reduction in ESAS dyspnea score 2 = 0, mean rank 1 = 11.30, mean rank 2 = 19.70, z = -2.692, r = 0.4, P = 0.007).","[{'ForeName': 'Diana Leh-Ching', 'Initials': 'DL', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Kota Samarahan, Sarawak, Malaysia.'}, {'ForeName': 'Chee-Shee', 'Initials': 'CS', 'LastName': 'Chai', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Kota Samarahan, Sarawak, Malaysia.'}, {'ForeName': 'Kok-Leng', 'Initials': 'KL', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University Sains Malaysia, Kelantan, Malaysia.'}, {'ForeName': 'Kok-Han', 'Initials': 'KH', 'LastName': 'Chee', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Yu-Zhen', 'Initials': 'YZ', 'LastName': 'Tung', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Suet-Yen', 'Initials': 'SY', 'LastName': 'Wai', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wei-Ting Joyce', 'Initials': 'WJ', 'LastName': 'Teo', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Bin-Ting', 'Initials': 'BT', 'LastName': 'Ang', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Min-Ai', 'Initials': 'MA', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Seng-Beng', 'Initials': 'SB', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",The American journal of hospice & palliative care,['10.1177/1049909120934743'] 2826,32588671,Observation on the effects of 595- nm pulsed dye laser and 755- nm long-pulsed alexandrite laser on sequential therapy of infantile hemangioma.,"BACKGROUND Infantile hemangioma (IH) can lead to severe complications. The 595-nm pulsed dye laser is poorly effective on thick and deep IH. Long-pulsed alexandrite laser has the proper wavelength of 755 nm and a relatively deep penetration. Thus, this may be a safe and effective treatment method for relatively deep or thick IH. AIMS AND OBJECTIVES This study aims to determine whether 595-nm pulsed dye laser and 755-nm long-pulsed alexandrite laser in sequential therapy are safer and more effective for relatively deep or thick hemangioma. MATERIALS AND METHODS This was a prospective study. A total of 194 infantile IH patients (thickness greater than 2 mm and less than 8 mm) were randomly divided into two groups: control group (treated using 595-nm pulsed dye laser) and experimental group (treated by sequential therapy with 755-nm long-pulsed alexandrite laser and 595-nm dye laser). RESULTS The control group had a total effective rate of 36.1%, while the experimental group had a total effective rate of 76.3%. Enumeration data were compared by X 2 -test. The results were considered statistically significant at P < .05. CONCLUSION Sequential therapy with 755-nm pulsed dye laser and 595-nm long-pulsed alexandrite laser is a safe and effective treatment approach for relatively deep or thick hemangioma.",2020,"The control group had a total effective rate of 36.1%, while the experimental group had a total effective rate of 76.3%.","['194 infantile IH patients (thickness greater than 2 mm and less than 8 mm', 'infantile hemangioma']","['595- nm pulsed dye laser and 755- nm long-pulsed alexandrite laser', '595-nm pulsed dye laser and 755-nm long-pulsed alexandrite laser', '755-nm pulsed dye laser and 595-nm long-pulsed alexandrite laser', '595-nm pulsed dye laser', 'Long-pulsed alexandrite laser', 'control group (treated using 595-nm pulsed dye laser) and experimental group (treated by sequential therapy with 755-nm long-pulsed alexandrite laser and 595-nm dye laser']",['total effective rate'],"[{'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C5191367', 'cui_str': '595'}, {'cui': 'C0392258', 'cui_str': 'Dye laser device'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0392245', 'cui_str': 'Alexandrite laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1289859', 'cui_str': 'Pulsed dye laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.017411,"The control group had a total effective rate of 36.1%, while the experimental group had a total effective rate of 76.3%.","[{'ForeName': 'Wan-Wan', 'Initials': 'WW', 'LastName': 'Jin', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Wu', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'He-He', 'Initials': 'HH', 'LastName': 'Quan', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University , Wenzhou, Zhejiang, China.""}]",Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology,['10.1080/14764172.2020.1783452'] 2827,32588685,Study of the Functional Brain Connectivity and Lower-Limb Motor Imagery Performance After Transcranial Direct Current Stimulation.,"The use of transcranial direct current stimulation (tDCS) has been related to the improvement of motor and learning tasks. The current research studies the effects of an asymmetric tDCS setup over brain connectivity, when the subject is performing a motor imagery (MI) task during five consecutive days. A brain-computer interface (BCI) based on electroencephalography is simulated in offline analysis to study the effect that tDCS has over different electrode configurations for the BCI. This way, the BCI performance is used as a validation index of the effect of the tDCS setup by the analysis of the classifier accuracy of the experimental sessions. In addition, the relationship between the brain connectivity and the BCI accuracy performance is analyzed. Results indicate that tDCS group, in comparison to the placebo sham group, shows a higher significant number of connectivity interactions in the motor electrodes during MI tasks and an increasing BCI accuracy over the days. However, the asymmetric tDCS setup does not improve the BCI performance of the electrodes in the intended hemisphere.",2020,"Results indicate that tDCS group, in comparison to the placebo sham group, shows a higher significant number of connectivity interactions in the motor electrodes during MI tasks and an increasing BCI accuracy over the days.",[],"['transcranial direct current stimulation (tDCS', 'tDCS', 'placebo']","['Functional Brain Connectivity and Lower-Limb Motor Imagery Performance', 'brain connectivity and the BCI accuracy performance', 'BCI accuracy', 'BCI performance', 'connectivity interactions']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",,0.0405879,"Results indicate that tDCS group, in comparison to the placebo sham group, shows a higher significant number of connectivity interactions in the motor electrodes during MI tasks and an increasing BCI accuracy over the days.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ortiz', 'Affiliation': 'Brain-Machine Interface Systems Lab, Miguel Hernández University of Elche, Avenida Universidad sn. Ed. Innova, Elche, Alicante 03202, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Iáñez', 'Affiliation': 'Brain-Machine Interface Systems Lab, Miguel Hernández University of Elche, Avenida Universidad sn. Ed. Innova, Elche, Alicante 03202, Spain.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Gaxiola-Tirado', 'Affiliation': ""Center for Research and Advanced Studies (Cinvestav), Monterrey's Unit, Vía del Conocimiento 201 PIIT, 66600, Apodaca NL 66600, Mexico.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gutiérrez', 'Affiliation': ""Center for Research and Advanced Studies (Cinvestav), Monterrey's Unit, Vía del Conocimiento 201 PIIT, 66600, Apodaca NL 66600, Mexico.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Azorín', 'Affiliation': 'Systems Engineering and Automation Department, Miguel Hernández University of Elche, Avenida Universidad sn. Ed. Innova, Elche, Alicante 03202, Spain.'}]",International journal of neural systems,['10.1142/S0129065720500380'] 2828,32588715,Effects of Life Skill Training on the School Violence Attitudes and Behavior Among Elementary School Children.,"This study evaluated a life skill training program on school violence given to elementary school children. A quasi-experimental study was conducted, and a 12-week intervention was implemented targeting 70 students aged between 10 and 11 years. The instruments included peer competency, attitudes toward school violence, experience of school violence, and the Self-Control Rating Scale. The data were analyzed using repeated measure analysis of variance. A significant difference was observed between the groups over time on peer competency ( F = 4.17, p = .020), attitudes toward school violence ( F = 6.02, p = .004), and violence experience as a victim ( F = 3.49, p = .036) and as a perpetrator ( F = 3.87, p = .026). In the experimental group, the mean scores for peer competency increased compared to the control group, whereas school violence experience decreased at the posttests. A 12-week program of life skill training offered to children was effective in promoting peer competency and attitudes toward school violence, while decreasing the experience of school violence.",2020,"In the experimental group, the mean scores for peer competency increased compared to the control group, whereas school violence experience decreased at the posttests.","['Elementary School Children', 'school violence given to elementary school children', '70 students aged between 10 and 11 years']","['life skill training program', 'life skill training', 'Life Skill Training']","['peer competency, attitudes toward school violence, experience of school violence, and the Self-Control Rating Scale', 'time on peer competency', 'peer competency and attitudes toward school violence', 'school violence experience', 'School Violence Attitudes and Behavior', 'violence experience as a victim', 'mean scores for peer competency', 'attitudes toward school violence']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0556562', 'cui_str': 'Life skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.00972077,"In the experimental group, the mean scores for peer competency increased compared to the control group, whereas school violence experience decreased at the posttests.","[{'ForeName': 'Jae Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Inha University, Incheon, South Korea.'}, {'ForeName': 'Ok Kyung', 'Initials': 'OK', 'LastName': 'Ham', 'Affiliation': 'Department of Nursing, Inha University, Incheon, South Korea.'}, {'ForeName': 'Hyun Soo', 'Initials': 'HS', 'LastName': 'Oh', 'Affiliation': 'Department of Nursing, Inha University, Incheon, South Korea.'}, {'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Inha University, Incheon, South Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'College of Nursing, Gachon University, Incheon, South Korea.'}, {'ForeName': 'Bongjeong', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Cheongju University, South Korea.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840520934183'] 2829,32588717,Sustained Effects From a School-Based Intervention Pilot Study for Children With Asthma and Anxiety.,"Children with chronic conditions (i.e., asthma) are more likely to have anxiety or depressive symptoms. Comorbid asthma and anxiety in children leads to increased morbidity, causing children to miss instructional time and parent/caregiver (CG) work absences. Asthma educational programs and mental health interventions have been developed, though no scalable programs integrate asthma education and mental health behavioral interventions for school-aged children. This study evaluated the sustained preliminary effects of an integrated asthma education and cognitive behavioral skills-building program, Creating Opportunities for Personal Empowerment for Asthma. Thirty-two children ages 8-12 years with asthma and symptoms of anxiety received the intervention. At 6-weeks postintervention, anxiety and CG-reported behavioral symptoms were significantly reduced, there were fewer missed doses of asthma controller medications, and asthma-related self-efficacy, personal beliefs, and the children's understanding of asthma significantly increased. Most children ( n = 29, 91%) reported continued use of coping skills.",2020,"At 6-weeks postintervention, anxiety and CG-reported behavioral symptoms were significantly reduced, there were fewer missed doses of asthma controller medications, and asthma-related self-efficacy, personal beliefs, and the children's understanding of asthma significantly increased.","['school-aged children', 'Children with chronic conditions (i.e., asthma', 'Thirty-two children ages 8-12 years with asthma and symptoms of anxiety received the intervention', 'Personal Empowerment for Asthma', 'Children With Asthma and Anxiety']",['integrated asthma education and cognitive behavioral skills-building program'],"['continued use of coping skills', 'asthma controller medications, and asthma-related self-efficacy, personal beliefs', 'anxiety and CG-reported behavioral symptoms']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}]",32.0,0.0159614,"At 6-weeks postintervention, anxiety and CG-reported behavioral symptoms were significantly reduced, there were fewer missed doses of asthma controller medications, and asthma-related self-efficacy, personal beliefs, and the children's understanding of asthma significantly increased.","[{'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'McGovern', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Arcoleo', 'Affiliation': 'University of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Melnyk', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, OH, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840520934178'] 2830,32588738,"Similar early functional recovery after total knee replacement comparing single shot versus continuous saphenous nerve block: A randomised, double-blind trial.","PURPOSE Total knee replacement (TKR) is associated with post-operative pain. Femoral nerve block can relieve the pain but also affects the post-operative mobility. Saphenous nerve block (SNB) can improve analgesia without interfering mobilisation. However, there is no consensus on the ideal mode of administration of SNB. We aim to compare the effects of single shot versus continuous SNB on patients undergoing TKR. METHODS Patients were randomised into two groups: single shot and continuous SNB groups. Post-operative rehabilitation and mobilisation were assessed by blinded physiotherapists, and preoperative and post-operative American knee scores were recorded by blinded specialised nurse. Post-operative analgesics usage was recorded by blinded pain nurses and anaesthetists. RESULTS Sixty-four patients were recruited; 6 patients withdrew with 29 patients in each group. There is no significant difference in early mobilisation and rehabilitation comparing both groups. The mean of the range gained on day 2 when compared to day 1 in single-shot SNB group was 17.41 ± 19.67° versus continuous SNB group was 23.45 ± 19.18° ( p = 0.149). The mean of the range gained on day 3 when compared to day 1 in single-shot group was 27.24 ± 22.66° versus continuous SNB group was 29.31 ± 21.57° ( p = 0.6). The mean of maximum flexion achieved by day 3 in single-shot SNB group was 92.41 ± 9.6° versus continuous SNB was 91.90 ± 7.95° ( p = 0.84). The day of reaching maximum flexion and the goal of 40 m showed no significant difference. Length of stay (LOS), difference in post-operative American Knee Society knee score at 3 months and analgesics usage showed no significant difference. CONCLUSION There is no significant difference in comparing the effect on mobilisation, LOS, early clinical outcome, analgesics usage in the single-shot group and the continuous SNB group.",2020,"There is no significant difference in comparing the effect on mobilisation, LOS, early clinical outcome, analgesics usage in the single-shot group and the continuous SNB group.","['patients undergoing TKR', 'Patients', 'Sixty-four patients were recruited; 6 patients withdrew with 29 patients in each group']","['total knee replacement comparing single shot versus continuous saphenous nerve block', 'Saphenous nerve block (SNB', 'Total knee replacement (TKR', 'single shot versus continuous SNB']","['mobilisation, LOS, early clinical outcome, analgesics usage', 'pain', 'mean of maximum flexion', 'early mobilisation and rehabilitation', 'Length of stay (LOS), difference in post-operative American Knee Society knee score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394744', 'cui_str': 'Local anesthetic saphenous nerve block'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.0970219,"There is no significant difference in comparing the effect on mobilisation, LOS, early clinical outcome, analgesics usage in the single-shot group and the continuous SNB group.","[{'ForeName': 'Ho Yee Joyce', 'Initials': 'HYJ', 'LastName': 'Lam', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}, {'ForeName': 'Yan Ho Bruce', 'Initials': 'YHB', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}, {'ForeName': 'Hok Leung', 'Initials': 'HL', 'LastName': 'Wong', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}, {'ForeName': 'Isaac Bruce', 'Initials': 'IB', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020932037'] 2831,32588746,Comparison of early and on-demand maternal feeding after Caesarean delivery: a prospective randomised trial.,"INTRODUCTION This study aimed to compare early and on-demand maternal feeding after Caesarean delivery in terms of gastrointestinal complaints and patient satisfaction. METHODS A total of 262 women with uncomplicated singleton term pregnancies who underwent a Caesarean section under regional anaesthesia were randomised to a soft food diet served at Postoperative Hour 2 (early feeding group) or eating whenever they wanted to upon return to the ward (on-demand group). Patient satisfaction scores at the time of discharge and gastrointestinal complaints were compared. RESULTS 133 (50.8%) women were in the fed-early group and 129 (49.2%) in the on-demand group. Major characteristics and surgical procedures were comparable between the two groups. No significant between-group differences in demographic criteria or surgical procedures were evident (p > 0.05). The mean time to the first feeding was 120.00 ± 00.00 minutes for the early feeding group as compared to 236.59 ± 107.74 minutes for the on-demand feeding group (p = 0.001). Satisfaction levels did not differ significantly between the two groups (p = 0.366). Duration to first breastfeeding, analgesia on the ward, passage of flatus, defecation, mobilisation and urination after catheter removal did not differ significantly between the two groups (p > 0.05). CONCLUSION Early initiation of solid food in low-risk women after Caesarean delivery under regional anaesthesia was associated with high satisfaction and did not increase gastrointestinal complaints. We suggest having flexibility in terms of postoperative feeding time. This may shorten hospitalisation time and decrease hospitalisation costs.",2020,Early initiation of solid food in low-risk women after Caesarean delivery under regional anaesthesia was associated with high satisfaction and did not increase gastrointestinal complaints.,"['low-risk women after Caesarean delivery under regional anaesthesia', '262 women with uncomplicated singleton term pregnancies who underwent a Caesarean section under regional anaesthesia', 'Comparison of early and on-demand maternal feeding after Caesarean delivery', '133 (50.8']",['soft food diet served at Postoperative Hour 2 (early feeding group) or eating whenever they wanted to upon return to the ward'],"['gastrointestinal complaints', 'demographic criteria or surgical procedures', 'Patient satisfaction scores', 'Duration to first breastfeeding, analgesia on the ward, passage of flatus, defecation, mobilisation and urination after catheter removal', 'Satisfaction levels', 'mean time to the first feeding', 'hospitalisation time and decrease hospitalisation costs']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C0301569', 'cui_str': 'Soft diet'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",262.0,0.036962,Early initiation of solid food in low-risk women after Caesarean delivery under regional anaesthesia was associated with high satisfaction and did not increase gastrointestinal complaints.,"[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ozbasli', 'Affiliation': 'Acibadem Mehmet Ali Aydinlar University, Acibadem Maslak University Hospital, Obstetrics and Gynecology Department, İstanbul, Turkey.'}, {'ForeName': 'Ozguc', 'Initials': 'O', 'LastName': 'Takmaz', 'Affiliation': 'Acibadem Mehmet Ali Aydinlar University, Acibadem Maslak University Hospital, Obstetrics and Gynecology Department, İstanbul, Turkey.'}, {'ForeName': 'Faruk Suat', 'Initials': 'FS', 'LastName': 'Dede', 'Affiliation': 'Acibadem Mehmet Ali Aydinlar University, Acibadem Maslak University Hospital, Obstetrics and Gynecology Department, İstanbul, Turkey.'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Gungor', 'Affiliation': 'Acibadem Mehmet Ali Aydinlar University, Acibadem Maslak University Hospital, Obstetrics and Gynecology Department, İstanbul, Turkey.'}]",Singapore medical journal,['10.11622/smedj.2020096'] 2832,32588785,"Association between change in maternal physical activity during pregnancy and infant size, in a sample overweight or obese women.","Physical activity (PA) naturally declines during pregnancy and its effects on infant size are unclear, especially in overweight or obese pregnancies, a low-active subpopulation that tends deliver heavier infants. The objective of this study was to evaluate changes in prenatal PA and infant birthweight in a group of overweight or obese pregnant women. We employed a prospective analysis using data from a randomized controlled exercise trial (2001 to 2006) in sedentary, overweight or obese pregnant women in Michigan. Women with complete data on peak oxygen consumption, daily PA (via pedometers) and birthweight were included in the analyses. Change in PA was estimated via repeated measures analyses, and then its influence on infant birthweight was assessed via linear regression. Eighty-nine pregnant women were included and considered low-active (6,579.91 ± 2379.17 steps/day). PA declined from months 4 to 8 (-399.73 ± 371.38 steps∙day -1 ∙month -1 ). Analyses showed that the decline in PA (β = -0.28 g, 95%CI: -0.70, 0.25 g, p = .35) was not associated with birthweight. The findings of this study demonstrated that the decline in maternal PA during mid- to late-pregnancy, in overweight or obese women, was unrelated to infant birthweight. Future investigations should employ rigorous measurements of PA and infant anthropometry in this subpopulation.",2020,PA declined from months 4 to 8 (-399.73 ± 371.38 steps∙day -1 ∙month -1 ).,"['Eighty-nine pregnant women were included and considered low-active (6,579.91\xa0±\xa02379.17 steps/day', 'group of overweight or obese pregnant women', 'sample overweight or obese women', '2001 to 2006) in sedentary, overweight or obese pregnant women in Michigan']",[],"['peak oxygen consumption, daily PA (via pedometers) and birthweight', 'prenatal PA and infant birthweight', 'maternal PA', 'maternal physical activity']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",89.0,0.122053,PA declined from months 4 to 8 (-399.73 ± 371.38 steps∙day -1 ∙month -1 ).,"[{'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'McDonald', 'Affiliation': 'School of Dental Medicine, East Carolina University , Greenville, North Carolina, USA.'}, {'ForeName': 'SeonAe', 'Initials': 'S', 'LastName': 'Yeo', 'Affiliation': 'College of Nursing, University of North Carolina , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': 'University of South Carolina , Columbia, SC, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'University of South Carolina , Columbia, SC, USA.'}, {'ForeName': 'Russell R', 'Initials': 'RR', 'LastName': 'Pate', 'Affiliation': 'University of South Carolina , Columbia, SC, USA.'}]",Women & health,['10.1080/03630242.2020.1779904'] 2833,32588803,Use of Typhoid Vi-Polysaccharide Vaccine as a Vaccine Probe to Delineate Clinical Criteria for Typhoid Fever.,"Blood cultures (BCs) detect an estimated 50% of typhoid fever cases. There is need for validated clinical criteria to define cases that are BC negative, both to help direct empiric antibiotic treatment and to better evaluate the magnitude of protection conferred by typhoid vaccines. To derive and validate a clinical rule for defining BC-negative typhoid fever, we assessed, in a cluster-randomized effectiveness trial of Vi-polysaccharide (ViPS) typhoid vaccine in Kolkata, India, 14,797 episodes of fever lasting at least 3 days during 4 years of comprehensive, BC-based surveillance of 70,865 persons. A recursive partitioning algorithm was used to develop a decision rule to predict BC-proven typhoid cases with a diagnostic specificity of 97-98%. To validate this rule as a definition for BC-negative typhoid fever, we assessed whether the rule defined culture-negative syndromes prevented by ViPS vaccine. In a training subset of individuals, we identified the following two rules: rule 1: patients aged < 15 years with prolonged fever accompanied by a measured body temperature ≥ 100°F, headache, and nausea; rule 2: patients aged ≥ 15 years with prolonged fever accompanied by nausea and palpable liver but without constipation. The adjusted protective efficacy of ViPS against clinical typhoid defined by these rules in persons aged ≥ 2 years in a separate validation subset was 33% (95% CI: 4-53%). We have defined and validated a clinical rule for predicting BC-negative typhoid fever using a novel vaccine probe approach. If validated in other settings, this rule may be useful to guide clinical care and to enhance typhoid vaccine evaluations.",2020,A recursive partitioning algorithm was used to develop a decision rule to predict BC-proven typhoid cases with a diagnostic specificity of 97-98%.,"['patients aged < 15 years with prolonged fever accompanied by a measured body temperature ≥ 100°F, headache, and nausea; rule 2: patients aged ≥ 15 years with prolonged fever accompanied by nausea and palpable liver but without constipation', 'Kolkata, India, 14,797 episodes of fever lasting at least 3 days during 4 years of comprehensive, BC-based surveillance of 70,865 persons']","['Typhoid Vi-Polysaccharide Vaccine', 'Vi-polysaccharide (ViPS) typhoid vaccine', 'ViPS']",['Blood cultures (BCs) detect'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0577045', 'cui_str': 'Liver palpable'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0078221', 'cui_str': 'Typhoid Vi Polysaccharide Vaccine, S typhi Ty2 strain'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0041469', 'cui_str': 'Typhoid vaccine'}]","[{'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]",,0.333085,A recursive partitioning algorithm was used to develop a decision rule to predict BC-proven typhoid cases with a diagnostic specificity of 97-98%.,"[{'ForeName': 'Taufiqul', 'Initials': 'T', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Im', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Ahmmed', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ashraful Islam', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Marks', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'Korea University College of Medicine, Seoul, South Korea.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0968'] 2834,32588878,Caplacizumab: an anti-von Willebrand factor antibody for the treatment of thrombotic thrombocytopenic purpura.,"PURPOSE The pharmacology, pharmacokinetics, efficacy, safety, dosing and administration, and place in therapy of caplacizumab, a novel antibody fragment that inhibits von Willebrand factor, for the treatment of acquired thrombotic thrombocytopenic purpura (TTP) are summarized. SUMMARY Caplacizumab is a humanized anti-von Willebrand factor monoclonal antibody fragment that inhibits the interaction between ultralarge von Willebrand factor multimers and platelets. Caplacizumab is indicated for use in combination with standard-of-care modalities such as plasma exchange and immunosuppressive therapy for the treatment of adults with acquired TTP. By inhibiting von Willebrand factor, caplacizumab offers a new approach to the management of TTP by preventing the development of potentially life-threatening microvascular thrombosis that can occur in the disease process. In a randomized, placebo-controlled phase 3 trial, patients with acquired TTP treated with caplacizumab had more rapid platelet level normalization than placebo users; caplacizumab use also resulted in lower rates of disease recurrence and TTP-related death. The most common adverse events associated with caplacizumab use are bleeding-related events. In a phase 3 trial, serious bleeding-related adverse events were reported in 8 patients (11%) in the caplacizumab group and 1 patient (1%) in the placebo group. Caplacizumab is administered as an 11-mg intravenous loading dose 15 minutes prior to plasma exchange, followed by administration of 11 mg subcutaneously daily after plasma exchange. Once-daily caplacizumab administration can be continued for 30 days after the last plasma exchange. The medication and supplies for administration are provided as a single-use kit; patients should be trained on proper reconstitution and self-administration technique prior to the use of caplacizumab in the ambulatory setting. CONCLUSION Caplacizumab is a first-in-class von Willebrand factor inhibitor approved for the treatment of adults with acquired TTP.",2020,"In a phase 3 trial, serious bleeding-related adverse events were reported in 8 patients (11%) in the caplacizumab group and 1 patient (1%) in the placebo group.","['adults with acquired TTP', 'thrombotic thrombocytopenic purpura', 'patients with acquired TTP treated with']","['Caplacizumab', 'caplacizumab', 'placebo']","['rapid platelet level normalization', 'serious bleeding-related adverse events', 'rates of disease recurrence and TTP-related death', 'pharmacology, pharmacokinetics, efficacy, safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0857305', 'cui_str': 'Thrombocytopenic purpura'}, {'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3713057', 'cui_str': 'caplacizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0857305', 'cui_str': 'Thrombocytopenic purpura'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0342904,"In a phase 3 trial, serious bleeding-related adverse events were reported in 8 patients (11%) in the caplacizumab group and 1 patient (1%) in the placebo group.","[{'ForeName': 'Alyssa L', 'Initials': 'AL', 'LastName': 'Hollifield', 'Affiliation': 'High Point University Fred Wilson School of Pharmacy, High Point, NC.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Arnall', 'Affiliation': 'Specialty Pharmacy, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Moore', 'Affiliation': 'Department of Pharmacy, Levine Cancer Institute, Atrium Health, Concord, NC.'}]",American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists,['10.1093/ajhp/zxaa151'] 2835,32588891,Risk of Secondary Traumatic Stress in Treating Traumatized Military Populations: Results from the PTSD Clinicians Exchange.,"INTRODUCTION This study examined risk factors for secondary traumatic stress (STS) in behavioral health clinicians and whether access to the Post-Traumatic Stress Disorder (PTSD) Clinicians Exchange website mitigated STS risk. METHODS A diverse sample of clinicians (N = 605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings were randomized to a newsletter-only control group or the exchange group. The exchange website included resources for treating PTSD and promoting clinician well-being. Online surveys were administered at 0-, 6-, and 12-months postrandomization. Regression analyses were used to examine the link among risk factors, exchange access, and STS. RESULTS Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs if required were not linked with STS at the 12-month assessment period. Providing care at the VA, more burnout, less compassion satisfaction, greater trauma caseload, less openness to new EBPs, and greater divergence from EBP procedures were linked with greater STS. Only burnout and divergence were associated with STS after accounting for other significant STS risk factors. Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence. CONCLUSIONS Given that burnout was linked with STS, future intervention may use techniques targeting burnout and STS (eg, emotion regulation strategies). Research exploring the link between divergence from EBPs and STS may inform EBP dissemination efforts and STS interventions. Finally, results highlight the need for research optimizing STS intervention efficacy among clinicians treating military populations.",2020,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence. ","['Treating Traumatized Military Populations', 'A diverse sample of clinicians (N\xa0=\xa0605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings']",[],"['Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs', 'STS levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",605.0,0.0367443,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence. ","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Penix', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Clarke-Walper', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Magnavita', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'Palo Alto Veterans Institute for Research, 3801 Miranda Avenue, Palo Alto, CA 94304.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Marceau', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Josef I', 'Initials': 'JI', 'LastName': 'Ruzek', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Wilk', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}]",Military medicine,['10.1093/milmed/usaa078'] 2836,32588919,Progressive resistance training for adolescents with cerebral palsy: the STAR randomized controlled trial.,"AIM To evaluate the effect of progressive resistance training of the ankle plantarflexors on gait efficiency, activity, and participation in adolescents with cerebral palsy (CP). METHOD Sixty-four adolescents (10-19y; 27 females, 37 males; Gross Motor Function Classification System [GMFCS] levels I-III) were randomized to 30 sessions of resistance training (10 supervised and 20 unsupervised home sessions) over 10 weeks or usual care. The primary outcome was gait efficiency indicated by net nondimensional oxygen cost (NNcost). Secondary outcomes included physical activity, gross motor function, participation, muscle strength, muscle and tendon size, and muscle and tendon stiffness. Analysis was intention-to-treat. RESULTS Median attendance at the 10 supervised sessions was 80% (range 40-100%). There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158). There was also no evidence of between-group differences in secondary outcomes at 10 or 22 weeks. There were 123 adverse events reported by 27 participants in the resistance training group. INTERPRETATION We found that 10 supervised sessions and 20 home sessions of progressive resistance training of the ankle plantarflexors did not improve gait efficiency, muscle strength, activity, participation, or any biomechanical outcome among adolescents with CP.",2020,"There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158).","['adolescents with cerebral palsy (CP', 'adolescents with CP', 'Sixty-four adolescents (10-19y; 27 females, 37 males', 'adolescents with cerebral palsy']","['progressive resistance training', 'resistance training (10 supervised and 20 unsupervised home sessions', 'Progressive resistance training']","['gait efficiency, muscle strength, activity, participation, or any biomechanical outcome', 'gait efficiency, activity, and participation', 'gait efficiency indicated by net nondimensional oxygen cost (NNcost', 'Median attendance', 'physical activity, gross motor function, participation, muscle strength, muscle and tendon size, and muscle and tendon stiffness']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",,0.106891,"There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158).","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Ryan', 'Affiliation': 'Department of Public Health and Epidemiology, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lavelle', 'Affiliation': 'College of Health and Life Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Theis', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Noorkoiv', 'Affiliation': 'College of Health and Life Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Kilbride', 'Affiliation': 'College of Health and Life Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Korff', 'Affiliation': 'Research and Development, Frogbikes, Ascot, UK.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Baltzopoulos', 'Affiliation': 'Research Institute for Sport and Exercises Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Shortland', 'Affiliation': ""One Small Step Gait Laboratory, Guy's Hospital, London, UK.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Levin', 'Affiliation': 'Department of Physiotherapy, Swiss Cottage School and Development and Research Centre, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Developmental medicine and child neurology,['10.1111/dmcn.14601'] 2837,32588971,A randomized controlled trial of amyloid positron emission tomography results disclosure in mild cognitive impairment.,"INTRODUCTION Recent studies suggest that Alzheimer's disease (AD) biomarker disclosure has no discernable psychological impact on cognitively healthy persons. Far less is known about how such results affect symptomatic individuals and their caregivers. METHODS Randomized controlled trial of 82 mild cognitive impairment (MCI) patient and caregiver dyads (total n = 164) to determine the effect of receiving amyloid positron emission tomography results on understanding of, and perceived efficacy to cope with, MCI over 52 weeks of follow-up. RESULTS Gains in the primary outcomes were not consistently observed. Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive. There was no corresponding increase in depressive symptoms. DISCUSSION These findings point to the possibility that both MCI patients and caregivers may need emotional support after the disclosure of amyloid scan results.",2020,"Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive.","['mild cognitive impairment', '82 mild cognitive impairment (MCI) patient and caregiver dyads (total n = 164', 'cognitively healthy persons']",['amyloid positron emission tomography'],"['sustained emotional distress', 'depressive symptoms']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",82.0,0.143392,"Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive.","[{'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lingler', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Klunk', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Knox', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'McDade', 'Affiliation': 'Department of Neurology, School of Medicine, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Roberts', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Tamres', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Lopez', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12129'] 2838,32589056,"Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.","IMPACT-AFib was an 80,000-patient randomized clinical trial implemented by five US insurance companies (health plans) aimed at increasing the use of oral anticoagulants by individuals with atrial fibrillation who were at high risk of stroke and not on treatment. The underlying thesis was that patients could be change agents to initiate prescribing discussions with their providers. We tested the effect of mailing information to both patients and their providers. We used administrative medical claims and pharmacy dispensing data to identify eligible patients, to randomize them to an early or delayed intervention, and to assess clinical outcomes. The core data were analysis-ready datasets each site had created and curated for the FDA's Sentinel System, supplemented by updated ""fresh"" pharmacy and enrollment data to ensure eligibility at the time of intervention. Following mutually agreed upon procedures, sites linked to additional internal source data to implement the intervention-educational information mailed to patients and their providers in the early intervention arm, and to providers of patients in the delayed intervention arm approximately 12 months later. The primary analysis compares the early intervention arm to the delayed intervention arm, prior to the delayed intervention being conducted (i.e. compares intervention to non-intervention). The endpoints of interest were evidence of initiation of anticoagulation (primary) as well as clinical endpoints, including stroke and hospitalization for bleeding. Major challenges, some unanticipated, identified during the planning phase include convening multi-stakeholder investigator teams and advisors, addressing ethical concerns about not intervening in a usual care comparison group, and identifying and avoiding interference with sites' routine programs that were similar to the intervention. Needs and challenges during the implementation phase included the fact that even limited site-specific programming greatly increased time and effort, the need to refresh research data extracts immediately before outreach to patients and providers, potential difficulty identifying low-cost medications such as warfarin that may not be reimbursed by health plans and so not discoverable in dispensing data, the need to develop workarounds when ""providers"" in claims data were facilities, difficulty addressing clustering of patients by provider because providers can have multiple identifiers within and between health plans, and the need to anticipate loss to follow up because of health plan disenrollment or change in benefits. As pragmatic trials begin to shape evidence generation within clinical practice, investigators should anticipate issues inherent to claims data and working with multiple large sites. In IMPACT-AFib, we found that investing in collaboration and communication among all parties throughout all phases of the study helped ensure common understanding, early identification of challenges, and streamlined actual implementation.",2020,"Major challenges, some unanticipated, identified during the planning phase include convening multi-stakeholder investigator teams and advisors, addressing ethical concerns about not intervening in a usual care comparison group, and identifying and avoiding interference with sites' routine programs that were similar to the intervention.",['individuals with atrial fibrillation who were at high risk of stroke and not on treatment'],[],"['initiation of anticoagulation (primary) as well as clinical endpoints, including stroke and hospitalization for bleeding']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.037705,"Major challenges, some unanticipated, identified during the planning phase include convening multi-stakeholder investigator teams and advisors, addressing ethical concerns about not intervening in a usual care comparison group, and identifying and avoiding interference with sites' routine programs that were similar to the intervention.","[{'ForeName': 'Crystal J', 'Initials': 'CJ', 'LastName': 'Garcia', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore, Inc., Wilmington, DE, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Lin', 'Affiliation': 'OptumInsight Life Sciences, Inc., Boston, MA, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'McMahill-Walraven', 'Affiliation': 'Aetna Inc., a CVS Health Company, Blue Bell, PA, USA.'}, {'ForeName': 'Vinit', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Humana Healthcare Research, Humana Inc., Louisville, KY, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Parlett', 'Affiliation': 'HealthCore, Inc., Wilmington, DE, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'McCall', 'Affiliation': 'Rowan Tree Perspectives Consulting, Murrieta, CA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Platt', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Noelle M', 'Initials': 'NM', 'LastName': 'Cocoros', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520928426'] 2839,32589058,Effects of ACEi and ARB on post-exercise hypotension induced by exercises conducted at different times of day in hypertensive men.,"BACKGROUND Post-exercise hypotension (PEH) is greater after evening than morning exercise, but antihypertensive drugs may affect the evening potentiation of PEH. Objective: To compare morning and evening PEH in hypertensives receiving angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB). METHODS Hypertensive men receiving ACEi (n = 14) or ARB (n = 15) underwent, in a random order, two maximal exercise tests (cycle ergometer, 15 watts/min until exhaustion) with one conducted in the morning (7 and 9 a.m.) and the other in the evening (8 and 10 p.m.). Auscultatory blood pressure (BP) was assessed in triplicate before and 30 min after the exercises. Changes in BP (post-exercise - pre-exercise) were compared between the groups and the sessions using a two-way mixed ANOVA and considering P < .05 as significant. RESULTS In the ARB group, systolic BP decrease was greater after the evening than the morning exercise, while in the ACEi group, it was not different after the exercises conducted at the different times of the day. Additionally, after the evening exercise, systolic BP decrease was lower in the ACEi than the ARB group (ARB = -11 ± 8 vs -6 ± 6 and ACEi = -6 ± 7 vs. -8 ± 5 mmHg, evening vs. morning, respectively, P for interaction = 0.014). CONCLUSIONS ACEi, but not ARB use, blunts the greater PEH that occurs after exercise conducted in the evening than in the morning.",2020,"In the ARB group, systolic BP decrease was greater after the evening than the morning exercise, while in the ACEi group, it was not different after the exercises conducted at the different times of the day.","['hypertensives receiving angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB', 'hypertensive men', 'Hypertensive men receiving ACEi (n\xa0=\xa014) or ARB (n\xa0=\xa015']","['ACEi and ARB', 'maximal exercise tests (cycle ergometer']","['Changes in BP', 'systolic BP decrease', 'Auscultatory blood pressure (BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0700218,"In the ARB group, systolic BP decrease was greater after the evening than the morning exercise, while in the ACEi group, it was not different after the exercises conducted at the different times of the day.","[{'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Brito', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Luan', 'Initials': 'L', 'LastName': 'Azevêdo', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Peçanha', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Rafael Yokoyama', 'Initials': 'RY', 'LastName': 'Fecchio', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}, {'ForeName': 'Rafael Andrade', 'Initials': 'RA', 'LastName': 'Rezende', 'Affiliation': 'Department of Nephrology, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'Giovânio Vieira', 'Initials': 'GV', 'LastName': 'da Silva', 'Affiliation': 'Hypertension Unit, General Hospital, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pio-Abreu', 'Affiliation': 'Hypertension Unit, General Hospital, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'Décio', 'Initials': 'D', 'LastName': 'Mion', 'Affiliation': 'Hypertension Unit, General Hospital, Medical School, University of São Paulo , Brazil.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, USA.'}, {'ForeName': 'Claudia L M', 'Initials': 'CLM', 'LastName': 'Forjaz', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo , Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1783546'] 2840,32589073,"Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial.","OBJECTIVES Celecoxib is a selective cyclooxygenase (COX)-2 inhibitor that is commonly used to reduce the incidence of gastrointestinal (GI) complications in patients with rheumatoid arthritis (RA). CELBESTA® is a generic equivalent to CELEBREX®, a celecoxib preparation. This study compared the efficacy and safety of CELBESTA® and CELEBREX® in patients with RA. METHODS This was a multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority clinical trial. The primary endpoint was a change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale after 6 weeks of treatment. RESULTS After a washout period, 119 eligible subjects were randomized to one of two groups (CELBESTA® group, n = 61; CELEBREX® group, n = 58). CELBESTA® was not inferior to CELEBREX® because the upper limit of two-sided 95% confidence interval (CI) for the difference between the two groups (difference in the least square [LS] mean, -8.68 mm; two-sided 95% CI -16.59 mm to -0.77 mm) was less than the non-inferiority margin (10 mm). There were no significant differences in GI complications and renal toxicity. CONCLUSIONS CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.",2020,"CONCLUSIONS CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.","['patients with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA', 'patients with RA', '119 eligible subjects']","['CELBESTA® versus CELEBREX®', 'CELBESTA® and CELEBREX®', 'Celecoxib']","['incidence of gastrointestinal (GI) complications', 'GI complications and renal toxicity', 'efficacy and safety', 'change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale', 'tolerability and safety profiles', 'pain relief efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0719198', 'cui_str': 'Celebrex'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",119.0,0.734665,"CONCLUSIONS CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.","[{'ForeName': 'Hyun-Sook', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Ho', 'Initials': 'WH', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gyeongsang National University Hospital, JinJu, Republic of Korea.'}, {'ForeName': 'Sang-Hyon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Geun-Tae', 'Initials': 'GT', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jin-Wuk', 'Initials': 'JW', 'LastName': 'Hur', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Nowon Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Myeung-Su', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Republic of Korea.'}, {'ForeName': 'Yun Sung', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Seung-Jae', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060520931323'] 2841,32589129,"Prospective partially randomized comparison of clopidogrel loading versus maintenance dosing to prevent periprocedural myocardial infarction after stenting for stable angina pectoris: Results from the ""Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients (MECCA)"" study.","WHAT IS KNOWN AND OBJECTIVE Pre-treatment of clopidogrel 600 mg is better than 300 mg loading for reducing periprocedural myocardial infarction (PMI). We aimed to evaluate pre-treatment methods for preventing PMI among patients undergoing conventional coronary angiography (CAG) for stable angina pectoris. MATERIALS AND METHODS The study analyzed 402 patients who underwent percutaneous coronary intervention (PCI) during 2010 - 2011 at three Korean hospitals. Clopidogrel-naïve patients received routine maintenance therapy (75 mg/day for ≥ 5 days) and were randomly assigned to a 300-mg reload (RL) or only the maintenance dose (MD). Patients who received a loading dose (LD; 600 mg at 2 - 24 hours before the procedure) were entered into a non-randomized group. RESULTS After excluding patients who showed an abnormal creatinine kinase myocardial band (CK-MB) level, the study included 233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group. The LD group had a significantly higher rate of PMI (LD: 21, RL: 3, MD: 0 cases; p = 0.007) and a significant increase in the mean CK-MB levels after 8 hours (p = 0.016) and 24 h (p = 0.01). However, there was no difference in PMI between the RL and MD groups. Furthermore, no significant differences between the three groups were observed in the P2Y12 reaction unit (PRU) values (p = 0.57). Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. WHAT IS NEW AND CONCLUSION Clopidogrel maintenance is better than 600-mg loading for preventing PMI, and the RL protocol did not further prevent PMI.
.",2020,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. ","['233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group', 'patients undergoing', '402 patients who underwent percutaneous coronary intervention (PCI) during 2010\xa0-\xa02011 at three Korean hospitals', 'stable angina pectoris']","['clopidogrel loading', 'conventional coronary angiography (CAG', '300-mg reload (RL) or only the maintenance dose (MD', 'clopidogrel', 'Clopidogrel-naïve patients received routine maintenance therapy', 'Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram']","['rate of PMI', 'rate of moderate-to-severe GUSTO bleeding', 'periprocedural myocardial infarction', 'P2Y12 reaction unit (PRU) values', 'periprocedural myocardial infarction (PMI', 'mean CK-MB levels', 'PMI', 'abnormal creatinine kinase myocardial band (CK-MB) level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0740471', 'cui_str': 'Creatinine abnormal NOS'}]",233.0,0.0456417,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. ","[{'ForeName': 'Jae Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Je Sang', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Kyung Joo', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Joo', 'Affiliation': ''}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Do-Sun', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203644'] 2842,32589146,Statistical Issues and Lessons Learned from COVID-19 Clinical Trials with Lopinavir-Ritonavir and Remdesivir.,"BACKGROUND Recently, three randomized clinical trials on COVID-19 treatments were completed, one for lopinavir-ritonavir and two for remdesivir. One trial reported that remdesivir was superior to placebo in shortening the time to recovery, while the other two showed no benefit of the treatment under investigation. OBJECTIVE From statistical perspectives, we identify several key issues in the design and analysis of three COVID-19 trials and reanalyze the data from the cumulative incidence curves in the three trials using more appropriate statistical methods. METHODS The lopinavir-ritonavir trial enrolled 39 additional patients due to insignificant results after the sample size reached the planned number, which led to inflation of the type I error rate. The remdesivir trial of Wang et al. failed to reach the planned sample size due to a lack of eligible patients, while the bootstrap method was used to predict the quantity of clinical interest conditionally and unconditionally if the trial had continued to reach the originally planned sample size. Moreover, we used a terminal (or cure) rate model and a model-free metric known as the restricted mean survival time or the restricted mean time to improvement (RMTI) to analyze the reconstructed data. The remdesivir trial of Beigel et al. reported the median recovery time of the remdesivir and placebo groups and the rate ratio for recovery, while both quantities depend on a particular time point representing local information. We use the restricted mean time to recovery (RMTR) as a global and robust measure for efficacy. RESULTS For the lopinavir-ritonavir trial, with the increase of sample size from 160 to 199, the type I error rate was inflated from 0.05 to 0.071. The difference of RMTIs between the two groups evaluated at day 28 was -1.67 days (95% CI [-3.62, 0.28]; P=.09) in favor of lopinavir-ritonavir but not statistically significant. For the remdesivir trial of Wang et al., the difference of RMTIs at day 28 was -0.89 day (95% CI [-2.84, 1.06]; P=.37). The planned sample size was 453, yet only 236 patients were enrolled. The conditional prediction shows that the HR estimates would reach statistical significance if the target sample size had been maintained. For the remdesivir trial of Beigel et al., the difference of RMTRs between the remdesivir and placebo groups at day 30 was -2.7 days (95% CI [-4.0, -1.2]; P<.001), confirming the superiority of remdesivir. The difference in the recovery time at the 25th percentile (95% CI [-3, 0]; P=.65) was insignificant, while the differences manifested to be statistically significant at larger percentiles. CONCLUSIONS Based on the statistical issues and lessons learned from the recent three clinical trials on COVID-19 treatments, we suggest more appropriate approaches for the design and analysis for ongoing and future COVID-19 trials. CLINICALTRIAL ",2020,"The difference of RMTIs between the two groups evaluated at day 28 was -1.67 days (95% CI [-3.62, 0.28]; P=.09) in favor of lopinavir-ritonavir but not statistically significant.",['236 patients were enrolled'],"['lopinavir-ritonavir', 'Lopinavir-Ritonavir and Remdesivir', 'placebo']","['mean survival time', 'rate ratio for recovery', 'recovery time', 'RMTIs', 'median recovery time', 'mean time to recovery (RMTR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",39.0,0.188497,"The difference of RMTIs between the two groups evaluated at day 28 was -1.67 days (95% CI [-3.62, 0.28]; P=.09) in favor of lopinavir-ritonavir but not statistically significant.","[{'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Yin', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Run Run Shaw Building, The University of Hong KongPokfulam Road, Hong Kong, Hong Kong, HK.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Run Run Shaw Building, The University of Hong KongPokfulam Road, Hong Kong, Hong Kong, HK.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Statistics and Actuarial Science, The University of Hong Kong, Run Run Shaw Building, The University of Hong KongPokfulam Road, Hong Kong, Hong Kong, HK.'}]",JMIR public health and surveillance,['10.2196/19538'] 2843,32589148,Online Health Coaching for Spinal Cord Injury: Results from a Mixed Methods Feasibility Evaluation.,"BACKGROUND Individuals with spinal cord injury (SCI) have a high risk of experiencing secondary conditions like pressure injuries. Self-management programs may reduce the risk of such complications, but traditional programs have proven to be insufficiently tailored to the needs of people with SCI. To overcome barriers to self-management support, an online self-management program was developed for Canadians with SCI called ""SCI&U"". OBJECTIVE To evaluate the feasibility and potential impact of the ""SCI&U"" program in the context of a mixed-methods pilot study. METHODS The study followed an explanatory sequential mixed-methods design. Participants (N=11) were Canadians with SCI who had been living in the community for more than 1 year. Each took part in a self-paced, 6-session self-management program guided by a trained peer health coach. During most sessions participants could elect to discuss a health topic with their coach from a pre-defined list (e.g. Skin or Bowel Management). Quantitative data was gathered before and after program participation to assess program feasibility and impact; feasibility measures included attrition rates, frequency of health topics selected and recorded goals, while impact measures included measures of self-efficacy (UW-SES), mood (PHQ-8), secondary conditions (SCI-SCS) and resilience (SCI-QOL-R). Qualitative measures were based on post-intervention interviews; these were designed to confirm and expand upon quantitative results. Synthesis of quantitative and qualitative results was conducted at the reporting and interpretation level. RESULTS Of 11 participants, 10 completed pre- and post-assessments and 6 coaching sessions. Sessions lasted between 31 and 81 minutes (average 55 minutes) and the duration of the program ranged from 35 to 88 days (average 56 days). Diet and exercise were selected as health topics 40% of the time; mental health, bladder, pain and bowel management topics were chosen but less frequently. Pre- and post results demonstrated improvements with moderate effect sizes on the UW-SES and eHEALS (i.e. Hedges' g > 0.5). Effect sizes for measures of resilience (SCI-QOL-R), depression (PHQ-8) and secondary conditions (SCI-SCS) were small (i.e. Hedges' g > 0.3). Qualitative results confirmed a common focus on diet and exercise and defined coaches as sources of accountability, information, reassurance/affirmation, emotional and technical support. CONCLUSIONS Results demonstrate an online self-management program to be feasible and acceptable by Canadians with SCI. Results also indicate the potential for online, peer-led self-management programs to impact resilience, self-efficacy, mood and secondary complications. Finally, results illuminate the role of the coach in facilitating behaviour change. Future work seeks to validate these results in the context of a randomized controlled trial. CLINICALTRIAL ",2020,Pre- and post results demonstrated improvements with moderate effect sizes on the UW-SES and eHEALS,"['Spinal Cord Injury', 'Individuals with spinal cord injury (SCI', 'Participants (N=11) were Canadians with SCI who had been living in the community for more than 1 year']","['Online Health Coaching', 'SCI&U"" program']","['resilience (SCI-QOL-R), depression (PHQ-8) and secondary conditions (SCI-SCS', 'impact resilience, self-efficacy, mood and secondary complications', 'attrition rates, frequency of health topics selected and recorded goals, while impact measures included measures of self-efficacy (UW-SES), mood (PHQ-8), secondary conditions (SCI-SCS) and resilience (SCI-QOL-R', 'UW-SES and eHEALS']","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",11.0,0.0375081,Pre- and post results demonstrated improvements with moderate effect sizes on the UW-SES and eHEALS,"[{'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Allin', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shepherd', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, CA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Thorson', 'Affiliation': 'Spinal Cord Injury BC, Vancouver, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tomasone', 'Affiliation': 'School of Kinesiology and Health Studies, Queens University, Kingston, CA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Munce', 'Affiliation': 'Toronto Rehabilitation Institute, Toronto, CA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Linassi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, University of Saskatchewan, Saskatoon, CA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McBride', 'Affiliation': 'Spinal Cord Injury BC, Vancouver, CA.'}, {'ForeName': 'Tizneem', 'Initials': 'T', 'LastName': 'Jiancaro', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, CA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jaglal', 'Affiliation': 'Department of Physical Therapy, University of Toronto, Toronto, CA.'}]",JMIR rehabilitation and assistive technologies,['10.2196/16351'] 2844,32589153,Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial.,"BACKGROUND Mobile apps provide an accessible way to test new health-related methodologies. Tobacco is still the primary preventable cause of death in industrialized countries, constituting an important public health issue. New technologies provide novel opportunities that are effective in the cessation of smoking tobacco. OBJECTIVE This paper aims to evaluate the efficacy and usage of a mobile app for assisting adult smokers to quit smoking. METHODS We conducted a cluster randomized clinical trial. We included smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app. We carried out follow-up visits at 15, 30, and 45 days, and at 2, 3, 6, and 12 months. Participants of the intervention group had access to the Tobbstop mobile app designed by the research team. The primary outcomes were continuous smoking abstinence at 3 and 12 months. RESULTS A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day. Of participants in the intervention group, 34.15% (97/284) did not use the app. The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01). Participants in the intervention group who used the app regularly and correctly had a higher probability of not being smokers at 12 months (OR 7.20, 95% CI 2.14-24.20; P=.001) than the participants of the CG. CONCLUSIONS Regular use of an app for smoking cessation is effective in comparison with standard clinical practice. TRIAL REGISTRATION Clinicaltrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421.",2020,"The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01).","['A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day', 'smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app']",[],"['higher probability of not being smokers', 'continuous smoking abstinence', 'continuous abstention level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439228', 'cui_str': 'day'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",773.0,0.193476,"The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01).","[{'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Pallejà-Millán', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rey-Reñones', 'Affiliation': 'Departament de Ciències Mèdiques Bàsiques, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Barrera Uriarte', 'Affiliation': 'Institut Català de la Salut, Unitat de Suport a la Recerca Camp de Tarragona, Reus, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Granado-Font', 'Affiliation': 'Institut Català de la Salut, Unitat de Suport a la Recerca Camp de Tarragona, Reus, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Flores-Mateo', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Duch', 'Affiliation': ""Departament d'Enginyeria Informàtica i Matemàtiques, Universitat Rovira i Virgili, Tarragona, Spain.""}]",JMIR mHealth and uHealth,['10.2196/15951'] 2845,32589155,Improving the Lifestyle of Adolescents Through Peer Education and Support in Vietnam: Protocol for a Pilot Cluster Randomized Controlled Trial.,"BACKGROUND In Ho Chi Minh City, Vietnam, recent studies found a rapid increase in overweight and obesity in adolescents. There is a need for effective health promotion interventions to support healthy diets and encourage a physically active lifestyle. This study will help fill an evidence gap on effective interventions to prevent excess weight gain in adolescents and generate new insights about peer-led education to promote healthy lifestyles. OBJECTIVE We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City. Additionally, the efficacy of the intervention on adolescents' dietary practices and time spent on physical activity will also be measured in this pilot study. METHODS The Peer Education and Peer Support (PEPS) project is a pilot cluster randomized controlled trial with 2 intervention and 2 control schools. The intervention consists of 4 weekly education sessions of why and how to choose healthy food and drinks and how to be more physically active. Additionally, the intervention includes a school-based and online support system to help maintain student engagement during the intervention. We will use in-depth interviews with students, peer leaders, teachers, and parents; focus group discussions with peer educators; and direct observation of the school environment and peer leaders' interactions with the students. Acceptability and feasibility of the intervention will be assessed. We will also quantitatively assess limited efficacy by measuring changes in student' physical activity levels and dietary behaviors. RESULTS We delivered the peer education intervention at the start of each school year over 3 months for all new grade 6 adolescents in the selected schools, followed by peer support and home engagement activities over 6 months until the end of the school year. There was a baseline assessment and 2 post-intervention assessments: the first immediately after the intervention to assess the short-term impact and the second at the end of the school year to assess the sustained impact on changes in adiposity, diet, and physical activity. CONCLUSIONS The findings of this study will be used to develop a larger-scale cluster randomized controlled trial to examine the impact of a multicomponent, school- and home-based health promotion intervention. The trial will use innovative peer education methods to reduce overweight and obesity and improve dietary choices and physical activity levels in Vietnamese adolescents. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12619000421134; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376690&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/15930.",2020,"OBJECTIVE We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City.","['overweight and obesity in adolescents', 'Vietnamese adolescents', 'junior high school students in Ho Chi Minh City']","[""discussions with peer educators; and direct observation of the school environment and peer leaders' interactions with the students"", 'combined peer-led and peer support intervention', 'Peer Education and Peer Support', 'multicomponent, school- and home-based health promotion intervention', 'peer education intervention']","['feasibility and acceptability', 'changes in adiposity, diet, and physical activity', 'Acceptability and feasibility']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0860508,"OBJECTIVE We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City.","[{'ForeName': 'Hong K', 'Initials': 'HK', 'LastName': 'Tang', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngoc-Minh', 'Initials': 'NM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'The Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Trang H H D', 'Initials': 'THHD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'The Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}]",JMIR research protocols,['10.2196/15930'] 2846,32589156,Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial.,"BACKGROUND Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. OBJECTIVE The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. METHODS This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised. RESULTS Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. CONCLUSIONS This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. TRIAL REGISTRATION ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/17943.",2020,"Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. ","['infants born moderately or late preterm', 'N=110 infants born moderately or late preterm', 'Moderate and late preterm newborns and their parents', 'infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this', 'Preterm Infants in Chile', 'Preterm newborns']","['routine pediatric care', 'interactive guidance intervention', 'Interactive Guidance Intervention']","['higher probability of developing sustained social withdrawal', 'neonatal pain and painful invasive procedures', 'weight at birth and sustained social withdrawal', 'Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire', 'daily duration of skin-to-skin contact, breastfeeding, and parental visits']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008107', 'cui_str': 'Chile'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0424095', 'cui_str': 'Social withdrawal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.149628,"Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. ","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bustamante Loyola', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Perez Retamal', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Monica Isabel', 'Initials': 'MI', 'LastName': 'Morgues Nudman', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Maturana', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salinas Gonzalez', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Cox', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'González Mas', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Muñoz', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lopez', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Mendiburo-Seguel', 'Affiliation': 'Faculty of Education and Social Sciences, Universidad Andrés Bello, Santiago, Chile.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Simó', 'Affiliation': 'Faculty of Psychology, Universitat de Valencia, Valencia, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Palau Subiela', 'Affiliation': 'Spain Association for Infant Mental Health Since Gestation, Valencia, Spain.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guedeney', 'Affiliation': 'Hospital Bichat Claude Bernard, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",JMIR research protocols,['10.2196/17943'] 2847,32589229,"Association Between Lifestyle Factors, Vitamin and Garlic Supplementation, and Gastric Cancer Outcomes: A Secondary Analysis of a Randomized Clinical Trial.","Importance The associations of lifestyle factors with gastric cancer (GC) are still underexplored in populations in China. Long-term nutritional supplementation may prevent GC in high-risk populations, but the possible effect modification by lifestyle factors remains unknown. Objective To evaluate how lifestyle factors, including smoking, alcohol intake, and diet, may change the risk of GC incidence and mortality and whether the effects of vitamin and garlic supplementation on GC are associated with major lifestyle factors. Design, Setting, and Participants This is a secondary analysis of the Shandong Intervention Trial, a masked, randomized, placebo-controlled trial that aimed to assess the effect of vitamin and garlic supplementations and Helicobacter pylori treatment on GC in a factorial design with 22.3 years of follow-up. The study took place in Linqu County, Shandong province, China, a high-risk area for GC. Data were collected from Jully 1995 to December 2017. Overall, 3365 participants aged 35 to 64 years identified in 13 randomly selected villages who agreed to undergo gastroscopy were invited to participate in the trial and were included in the analysis. Data analysis was conducted from March to May 2019. Interventions Participants received vitamin and garlic supplementation for 7.3 years, H pylori treatment for 2 weeks (among participants with H pylori ), or placebo. Main Outcomes and Measures The primary outcomes were GC incidence and GC mortality (1995-2017). We also examined the progression of gastric lesions (1995-2003) as a secondary outcome. Results Of the 3365 participants (mean [SD] age, 47.1 [9.2] years; 1639 [48.7%] women), 1677 (49.8%) were randomized to receive active vitamin supplementation, with 1688 (50.2%) receiving placebo, and 1678 (49.9%) receiving active garlic supplementation, with 1687 (50.1%) receiving placebo. Overall, 151 GC cases (4.5%) and 94 GC deaths (2.8%) were identified. Smoking was associated with increased risk of GC incidence (odds ratio, 1.72; 95% CI, 1.003-2.93) and mortality (hazard ratio [HR], 2.01; 95% CI, 1.01-3.98). Smoking was not associated with changes to the effects of vitamin or garlic supplementation. The protective effect on GC mortality associated with garlic supplementation was observed only among those not drinking alcohol (never drank alcohol: HR, 0.33; 95% CI, 0.15-0.75; ever drank alcohol: HR, 0.92; 95% CI, 0.55-1.54; P for interaction = .03), and significant interactions were only seen among participants with H pylori (never drank alcohol: HR, 0.31; 95% CI, 0.12-0.78; ever drank alcohol: HR, 0.91; 95% CI, 0.52-1.60; P for interaction = .04). No significant interactions between vitamin supplementation and lifestyle factors were found. Conclusions and Relevance In this secondary analysis of a randomized clinical trial, smoking was associated with an increased risk of GC incidence and mortality. Not drinking alcohol was associated with a stronger beneficial effect of garlic supplementation on GC prevention. Our findings provide new insights into lifestyle intervention for GC prevention, suggesting that mass GC prevention strategies may need to be tailored to specific population subgroups to maximize the potential beneficial effect. Trial Registration ClinicalTrials.gov Identifier: NCT00339768.",2020,"Smoking was associated with increased risk of GC incidence (odds ratio, 1.72; 95% CI, 1.003-2.93) and mortality (hazard ratio [HR], 2.01; 95% CI, 1.01-3.98).","['3365 participants aged 35 to 64 years identified in 13 randomly selected villages who agreed to undergo gastroscopy were invited to participate in the trial and were included in the analysis', 'Linqu County, Shandong province, China, a high-risk area for GC', '3365 participants (mean [SD] age, 47.1 [9.2] years; 1639 [48.7%] women), 1677 (49.8']","['vitamin and garlic supplementation', 'active garlic supplementation', 'vitamin and garlic supplementations and Helicobacter pylori treatment', 'vitamin or garlic supplementation', 'garlic supplementation', 'active vitamin supplementation', 'placebo']","['risk of GC incidence', 'progression of gastric lesions', 'risk of GC incidence and mortality', 'mortality', 'GC incidence and GC mortality', 'Lifestyle Factors, Vitamin and Garlic Supplementation, and Gastric Cancer Outcomes', 'GC mortality associated with garlic supplementation']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0679408', 'cui_str': 'Lesion of stomach'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",3365.0,0.29091,"Smoking was associated with increased risk of GC incidence (odds ratio, 1.72; 95% CI, 1.003-2.93) and mortality (hazard ratio [HR], 2.01; 95% CI, 1.01-3.98).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Zhe-Xuan', 'Initials': 'ZX', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Jing-Yu', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Jun-Ling', 'Initials': 'JL', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Liu', 'Affiliation': 'Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Zhong-Xiang', 'Initials': 'ZX', 'LastName': 'Han', 'Affiliation': 'Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'You', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6628'] 2848,32589230,Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial.,"Importance Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic. Objective To investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer. Design, Setting, and Participants This was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019. Interventions Women were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily). Main Outcomes and Measures The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction. Results Of 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 patients [58.8%]; OR, 0.06; 95% CI, 0.01-0.25; P < .001) and pain associated with taking the medication (4 patients [2.1%] vs 92 patients [49.2%]; OR, 9.20; 95% CI, 2.67-31.82; P < .001). Conclusions and Relevance These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent. Trial Registration ClinicalTrials.gov Identifier: NCT02366871.",2020,"There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%];","['postoperative patients with gynecologic cancer', 'Interventions\n\n\nWomen', 'gynecologic cancer', 'Women undergoing surgery for suspected or confirmed gynecologic cancer', '2015 to March 2019 in outpatient and inpatient gynecologic oncology settings', '500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received', 'Women Undergoing Surgery for Gynecologic Malignant Neoplasm']","['apixaban or enoxaparin', 'apixaban', 'Apixaban vs Enoxaparin', 'enoxaparin', 'oral apixaban']","['Participant satisfaction', 'rates of major bleeding and clinically relevant nonmajor bleeding events', 'race/ethnicity, cancer stage, or surgery modality', 'Postoperative Venous Thromboembolism', 'clinically relevant nonmajor bleeding events', 'venous thromboembolic events', 'safety and efficacy', 'pain', 'incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction', 'major bleeding and clinically relevant nonmajor bleeding events', 'rates of major bleeding events', 'adverse events, medication adherence, or quality of life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",400.0,0.236392,"There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%];","[{'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Brennecke', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Behbakht', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tayebnejad', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Breed', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Babayan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Amin A', 'Initials': 'AA', 'LastName': 'Ramzan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Lindsay J', 'Initials': 'LJ', 'LastName': 'Wheeler', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Bradley R', 'Initials': 'BR', 'LastName': 'Corr', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lefkowits', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Keck School of Medicine, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Flink', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7410'] 2849,32589237,Effects of catheter orifice configuration (triple-hole versus end-hole) in continuous infraclavicular brachial plexus block on analgesia after upper limb surgery.,"BACKGROUND The configuration of a nerve block catheter may affect the local anesthetic spread in epidural analgesia and continuous peripheral nerve blocks. This prospective and randomized study aims to compare the multi-orifice nerve block catheter with an end-hole catheter in ultrasound-guided continuous infraclavicular brachial plexus block (BPB) in terms of providing postoperative analgesia for the orthopedic upper limb surgery below the shoulder. The primary outcome measure was mean pain scores. Secondary outcome measures were the consumption of rescue analgesic and the amount of local anesthetics delivered by a Patient-Controlled Analgesia (PCA) device. METHODS A total of 58 adult patients who underwent orthopedic upper limb surgery below the shoulder were randomly assigned into two groups: group end-hole catheter (EHC) (n=31) and group multi-orifice catheter (MOC) (n=27). All patients received a single-shot infraclavicular BPB using 100 mg lidocaine 2% and 75 mg bupivacaine 0.5% administrated through a Tuohy needle. Then, a multi-orifice (triple-hole) nerve catheter was placed in the group MOC and an end-hole (one-hole) catheter in the group EHC at the same location. Bupivacaine 0.125% was infused through the catheters via PCA (infusion rate: 2 mlh-1, automated regular bolus: 5 mlh-1, patient-controlled bolus: 3 ml, lock-out time: 1 hour, 4 hours limit: 40 ml). Pain intensity was evaluated using a visual analogue scale (VAS). RESULTS Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001). Mean rescue analgesic consumption, the number of bolus demand on PCA, PCA bolus demand dose, and total PCA dose were higher in group EHC than group MOC during the first postoperative day (p<0.05). CONCLUSION It is concluded that the use of MHC is more effective than EHC for continuous infraclavicular brachial plexus blocks in providing postoperative pain relief during the first 24 hours.",2020,"RESULTS Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001).","['58 adult patients who underwent orthopedic upper limb surgery below the shoulder', 'continuous infraclavicular brachial plexus block on analgesia after upper limb surgery', 'orthopedic upper limb surgery below the shoulder']","['EHC', 'catheter orifice configuration (triple-hole versus end-hole', 'Bupivacaine', 'bupivacaine', 'group end-hole catheter (EHC) (n=31) and group multi-orifice catheter (MOC) ', 'lidocaine', 'multi-orifice nerve block catheter with an end-hole catheter in ultrasound-guided continuous infraclavicular brachial plexus block (BPB', 'MHC']","['visual analogue scale (VAS', 'Pain intensity', 'consumption of rescue analgesic and the amount of local anesthetics delivered by a Patient-Controlled Analgesia (PCA) device', 'mean pain scores', 'Mean rescue analgesic consumption, the number of bolus demand on PCA, PCA bolus demand dose, and total PCA dose', 'Mean VAS scores', 'postoperative pain relief']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",58.0,0.068495,"RESULTS Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001).","[{'ForeName': 'Mehmet Burak', 'Initials': 'MB', 'LastName': 'Eskin', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences, Gülhane Faculty of Medicine, Ankara -Turkey.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'Ceylan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Gülhane Training and Research Hospital, Ankara-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2020.03302'] 2850,32589242,An investigation into the effects of hemodynamic changes on the patient's clinical condition during the treatment of patients undergoing aneurysmal subarachnoid hemorrhage.,"BACKGROUND In this study, we investigated the hemodynamic changes in patients with aneurysmal subarachnoid hemorrhage (aSAH) during the intensive care unit and the effects of PiCCO on the hemodynamic clinical course during hydration and hypertension treatment. METHODS In our study, 15 adult aSAH patients, whose aneurysm had been treated by surgery or coiling, were examined for the signs of vasospasm in between the dates 03/01/2015 and 01/03/2016. The PICCO measurement was made at least twice in a day. Positive daily fluid balance was attempted to be at least 1000 mL and the value of the Global end-diastolic index (GEDI) was targeted to 680 to 800 mL/m2 for each patient. The values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values were recorded. RESULTS It had been observed that CVP value was randomly changing during the volume therapy, but the GEDI value determined by thermodilution was consistent. A positive correlation was detected between the period of reaching the hospital and the first measured value of SVRI. Low GEDI value was detected as a risk factor in the perspective of vasospasm, but an ideal GEDI value could not be determined. CONCLUSION GEDI values were correlated with daily fluid balance. While low GEDI value was found as a risk factor, we could not determine an ideal GEDI value.",2020,"The values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values were recorded. ","['15 adult aSAH patients', 'patients with aneurysmal subarachnoid hemorrhage (aSAH', 'patients undergoing aneurysmal subarachnoid hemorrhage']",['PiCCO'],"['values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values', 'signs of vasospasm', 'GEDI values', 'Positive daily fluid balance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]",[],"[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index'}, {'cui': 'C0015380', 'cui_str': 'Lung Water, Extravascular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}]",15.0,0.0389726,"The values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values were recorded. ","[{'ForeName': 'Nihan', 'Initials': 'N', 'LastName': 'Yaman Mammadov', 'Affiliation': 'Department of Anesthesiology, University of Health Sciences, Van Training and Research Hospital, Van-Turkey.'}, {'ForeName': 'Achmet', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesiology, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Mammadov', 'Affiliation': 'Department of Intensive Care Unit, Altunizade Acıbadem Hospital, İstanbul-Turkey.'}, {'ForeName': 'Ararso Kedir', 'Initials': 'AK', 'LastName': 'Jima', 'Affiliation': 'Department of Intensive Care Unit, Altunizade Acıbadem Hospital, İstanbul-Turkey.'}, {'ForeName': 'Günseli', 'Initials': 'G', 'LastName': 'Orhun', 'Affiliation': 'Department of Anesthesiology, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Ibrahim Ozkan', 'Initials': 'IO', 'LastName': 'Akinci', 'Affiliation': 'Department of Intensive Care Unit, Taksim Acıbadem Hospital, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2020.24412'] 2851,32589244,The effects of analgesic treatment and chest physiotherapy on the complications of the patients with rib fractures that arise from blunt chest trauma.,"BACKGROUND This prospective study aims to investigate the effect of chest physiotherapy and analgesic therapy on the possible complications of isolated rib fractures attributable to blunt thoracic trauma, such as hemothorax and pneumothorax. METHODS Patients who presented to Çanakkale Onsekiz Mart University School of Medicine Hospital's Emergency Department and Thoracic Surgery outpatient clinics within the first 24 hours of the post-traumatic period and did not have additional intrathoracic complications at presentation with blunt thoracic trauma and who were diagnosed with isolated rib fractures were enrolled in this prospective research study. The groups were designated as the patients who would receive analgesic treatment only (Group A) and the patients who would receive chest physiotherapy and analgesic treatment together (Group B). Patients who had first and second rib fractures or three or more rib fractures and who did not have additional organ injury were hospitalized in the Thoracic Surgery clinics; patients who had other organ trauma were hospitalized in related clinics. Patients were reassessed on their seventh and 30th post-traumatic days with physical examination and radiologic studies. RESULTS The mean age of the 114 patients were 56.3±16.4 (22-87). There were 37 (32.5%) women and 77 (67.5%) men. Each group included 57 patients. The most common form of trauma was the same-level falls (31.6%). The mean number of rib fractures of all participants was 2.6±0.7 (1-10); the median number was 1.5. Fifty-two (45.6%) patients were hospitalized. The mean length of stay was 4.0±1.1 days. At the end of their treatment and follow-up periods, pleural effusion was found in 28 patients (24.6%) out of 114 enrolled at the side of trauma. Group B had a higher number of patients with pleural effusion (43.9%) than group A (5.3%). We performed tube thoracostomy in four patients, all of which were in group B (p<0.05). CONCLUSION As a result of this study, chest physiotherapy maneuvers have increased the incidence of late hemothorax in patients with three or more isolated rib fractures. Also, minimal hemothoraces (<300 ml) may spontaneously regress, and no additional surgical treatment are required if the proper follow-up procedures are performed. It is advisable to hospitalize the blunt thoracic trauma patients who have three or more rib fractures and who are planned to undergo chest physiotherapy and or are prone to develop additional complications because of possible risks.",2020,"We performed tube thoracostomy in four patients, all of which were in group B (p<0.05). ","['Each group included 57 patients', 'blunt thoracic trauma patients who have three or more rib fractures', 'Patients who had first and second rib fractures or three or more rib fractures and who did not have additional organ injury were hospitalized in the Thoracic Surgery clinics; patients who had other organ trauma were hospitalized in related clinics', 'Fifty-two (45.6%) patients were hospitalized', '28 patients (24.6%) out of 114 enrolled at the side of trauma', 'patients with three or more isolated rib fractures', ""Patients who presented to Çanakkale Onsekiz Mart University School of Medicine Hospital's Emergency Department and Thoracic Surgery outpatient clinics within the first 24 hours of the post-traumatic period and did not have additional intrathoracic complications at presentation with blunt thoracic trauma and who were diagnosed with isolated rib fractures"", 'The mean age of the 114 patients were 56.3±16.4 (22-87', 'patients with rib fractures that arise from blunt chest trauma', 'There were 37 (32.5%) women and 77 (67.5%) men', 'Patients were reassessed on their seventh and 30th post-traumatic days with physical examination and radiologic studies']","['chest physiotherapy and analgesic therapy', 'chest physiotherapy and analgesic treatment together', 'analgesic treatment and chest physiotherapy']","['mean length of stay', 'incidence of late hemothorax', 'higher number of patients with pleural effusion', 'mean number of rib fractures']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0920004', 'cui_str': 'Second rib fracture'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0039980', 'cui_str': 'Chest injury'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}]",114.0,0.0219527,"We performed tube thoracostomy in four patients, all of which were in group B (p<0.05). ","[{'ForeName': 'Timuçin', 'Initials': 'T', 'LastName': 'Alar', 'Affiliation': 'Department of Thoracic Surgery, Çanakkale Onsekiz Mart University Faculty of Medicine, Çanakkale-Turkey.'}, {'ForeName': 'İsmail Ertuğrul', 'Initials': 'İE', 'LastName': 'Gedik', 'Affiliation': 'Department of Thoracic Surgery, Erzurum Regional Education and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kara', 'Affiliation': 'Department of Thoracic Surgery, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.26356'] 2852,32589290,Sitting decreases endothelial microparticles but not circulating angiogenic cells irrespective of lower leg exercises: A randomized cross-over trial.,"NEW FINDINGS What is the central question of this study? Prolonged sitting increases risk for cardiovascular disease, but the cellular and molecular determinants remain unknown. What is the main finding and its importance? Prolonged sitting, independent of calf raise interruption strategies, decreases MP counts linked to endothelial activation and apoptosis. An acute bout of prolonged sitting appears to promote paradoxical decreases in microparticle counts, but the implications are not yet clear. ABSTRACT Repeated exposure to prolonged sitting increases the risk for cardiovascular disease. However, the cellular links by which repeated exposure to prolonged sitting lead to increased cardiovascular risk have not been fully elucidated, with markers of vascular damage and repair such as microparticles (MP) and circulating angiogenic cell (CAC) being promising targets. Purpose To examine the effects of 3 h of sitting with or without intermittent calf raises on Annexin V + /CD34 + , Annexin V + /CD62E + , and Annexin V + /CD31 + /42b - MP populations linked to CAC paracrine activity, endothelial activation, and apoptosis, respectively, as well as CD14 + /31 + , CD3 + /31 + , and CD34 + CACs which are linked to endothelial repair. Methods In a random order, 20 sedentary participants (14 females, 22 ± 3 years) remained seated for 180 minutes with or without performing 10 calf raises every 10 minutes. Blood samples were obtained after 20 minutes of quiet rest in the supine position before and after sitting. Results Overall, sitting decreased Annexin V + /CD34 + MPs (-12 ± 5 events/μl, P < 0.01), Annexin V + /CD62E + MPs (-17 ± 4 events/μl, P < 0.001), and Annexin V + /CD31 + /42b - MPs (-22 ± 6 events/μl, P < 0.001) regardless of condition. There were no differences in endothelin-1 plasma concentration, CD14 + /31 + , CD34 + or CD3 + /31 + CAC frequencies. Conclusion Sitting did not alter CAC number, but decreased MPs linked to endothelial activation, apoptosis and CAC paracrine activity in a manner that was independent of muscle contraction. These findings support changes in markers of endothelial activation and apoptosis with sedentary behavior and provide new insights into altered intercellular communication with physical inactivity such as prolonged sitting. This article is protected by copyright. All rights reserved.",2020,"There were no differences in endothelin-1 plasma concentration, CD14 + /31 + , CD34 + or CD3 + /31 + CAC frequencies.","['20 sedentary participants (14 females, 22\xa0±\xa03 years) remained seated for 180 minutes with or without performing 10 calf raises every 10 minutes']","['3\xa0h of sitting with or without intermittent calf raises on Annexin V + /CD34 + , Annexin V + /CD62E + , and Annexin V + /CD31']","['endothelin-1 plasma concentration', 'MPs linked to endothelial activation, apoptosis and CAC paracrine activity', 'sitting decreased Annexin V + /CD34 + MPs (-12\xa0±\xa05 events/μl, P\xa0<\xa00.01), Annexin V + /CD62E + MPs']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0585315', 'cui_str': 'Every ten minutes'}]","[{'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0059249', 'cui_str': 'Annexin V'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0059249', 'cui_str': 'Annexin V'}, {'cui': 'C4517393', 'cui_str': '0.01'}]",20.0,0.029173,"There were no differences in endothelin-1 plasma concentration, CD14 + /31 + , CD34 + or CD3 + /31 + CAC frequencies.","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina, Chapel Hill, North Carolina, 27599.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina, Chapel Hill, North Carolina, 27599.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Shill', 'Affiliation': 'Department of Kinesiology, The University of Maryland, College Park, Maryland, 20740.'}, {'ForeName': 'Rian Q', 'Initials': 'RQ', 'LastName': 'Landers-Ramos', 'Affiliation': 'Department of Kinesiology, Towson University, Towson, Maryland, 21252.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina, Chapel Hill, North Carolina, 27599.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Willey', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina, Chapel Hill, North Carolina, 27599.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, Mississippi, 39406.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Prior', 'Affiliation': 'Department of Kinesiology, The University of Maryland, College Park, Maryland, 20740.'}]",Experimental physiology,['10.1113/EP088690'] 2853,32584620,Evaluation of the Effectiveness of Psychoeducation Given to Children with Parental Psychiatric Disorders.,"This study was aimed to determine the effectiveness of psychoeducation program which was developed to improve the coping skills and to increase the psychological resistance of 12-18 years children/adolescents whose parents' have psychiatric disorders.The study was carried out between May 2018 - November 2019 with children of patients who applied to the outpatient clinic and inpatient treatment at Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine Department of Psychiatry. Total of 40 children (experiment = 20 and control = 20), participated in the study. Data were collected using Personal Information Form, Adolescent Psychological Resilience Scale and Kidcope.The mean age of the children/adolescents in the experimental group was 14.05 ± 1.90, 50% was male and the mean age of the control group was 15.35 ± 2.08, and 55% were male. It was determined that the mean duration of psychiatric disorders were 11.50 ± 6.39 years and 40% of the psychiatric diagnosis was schizophrenia in the experimental group, and the mean duration psychiatric disorders were 6.10 ± 5.16 years and 30% of the psychiatric diagnosis was a depression in the control group. After psychoeducation, the total scores of scales in the experimental group showed an increase compared to the control group and a significant difference in a statistical context.It was found that children/adolescents participating in the psychoeducation program had increased psychological resilience levels and improved coping skills. This result shows that the psychoeducation program for children/adolescents with psychiatric disorders in their parents is effective.",2020,It was found that children/adolescents participating in the psychoeducation program had increased psychological resilience levels and improved coping skills.,"['mean age of the children/adolescents in the experimental group was 14.05\u2009±\u20091.90, 50% was male and the mean age of the control group was 15.35\u2009±\u20092.08, and 55% were male', 'May 2018 - November 2019 with children of patients who applied to the outpatient clinic and inpatient treatment at Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine Department of Psychiatry', 'Children with Parental Psychiatric Disorders', ""12-18 years children/adolescents whose parents' have psychiatric disorders"", 'children/adolescents with psychiatric disorders', 'Total of 40 children (experiment = 20 and control = 20), participated in the study']","['Psychoeducation', 'psychoeducation program']","['total scores of scales', 'coping skills', 'mean duration psychiatric disorders', 'mean duration of psychiatric disorders', 'psychological resistance', 'psychological resilience levels and improved coping skills']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517626', 'cui_str': '2.08'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.0221932,It was found that children/adolescents participating in the psychoeducation program had increased psychological resilience levels and improved coping skills.,"[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Küçük', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Bilgin', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Çömez Ikican', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Institute of Graduate Education, Istanbul University - Cerrahpasa, Avcılar-Istanbul, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Kaçar', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Muhammed Tayyip', 'Initials': 'MT', 'LastName': 'Kadak', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Ömer Faruk', 'Initials': 'ÖF', 'LastName': 'Demirel', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Vahdi', 'Initials': 'V', 'LastName': 'Çoban', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Fatma Yasemin', 'Initials': 'FY', 'LastName': 'Kutlu', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Cana', 'Initials': 'C', 'LastName': 'Aksoy Poyraz', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Buzlu', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Alaattin', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1756010'] 2854,32584630,Efficacy and Safety of Vandetanib in Progressive and Symptomatic Medullary Thyroid Cancer: Post Hoc Analysis From the ZETA Trial.,"PURPOSE We conducted a post hoc analysis of the vandetanib phase III trial involving patients with advanced medullary thyroid cancer (MTC) to assess the efficacy and safety of vandetanib in patients with progressive and symptomatic MTC. The primary objective of the analysis was to determine progression-free survival (PFS) of these patients. PATIENTS AND METHODS Eligible patients from the ZETA trial were divided into 4 disease severity subgroups: progression and symptoms, symptoms only, progression only, and no progression and no symptoms assessed at baseline. PFS, determined from objective tumor measurements performed by the local investigator, overall survival (OS), time to worsening of pain (TWP), and objective response rate (ORR) were evaluated. RESULTS Of the 331 patients in this trial, 184 had symptomatic and progressive disease at baseline. In this subgroup, results were similar in magnitude to those observed in the overall trial for PFS (hazard ratio [HR], 0.43; 95% CI, 0.28 to 0.64; P < .0001), OS (HR, 1.08; 95% CI, 0.72 to 1.61; P = .71), and TWP (HR, 0.67; 95% CI, 0.43 to 1.04; P = .07), and the observed adverse events were consistent with the known safety profile of vandetanib. In this subgroup, the ORR was 37% in the treatment arm versus 2% in the placebo arm. CONCLUSION Vandetanib demonstrated clinical benefit-specifically, increased PFS-in patients with symptomatic and progressive MTC.",2020,"In this subgroup, results were similar in magnitude to those observed in the overall trial for PFS (hazard ratio [HR], 0.43; 95% CI, 0.28 to 0.64; P < .0001), OS (HR, 1.08; 95% CI, 0.72 to 1.61; P = .71), and TWP (HR, 0.67; 95% CI, 0.43 to 1.04; P = .07), and the observed adverse events were consistent with the known safety profile of vandetanib.","['Eligible patients from the ZETA trial were divided into 4 disease severity subgroups: progression and symptoms, symptoms only, progression only, and no progression and no symptoms assessed at baseline', 'patients with symptomatic and progressive MTC', 'Progressive and Symptomatic Medullary Thyroid Cancer', '331 patients in this trial, 184 had symptomatic and progressive disease at baseline', 'patients with progressive and symptomatic MTC', 'patients with advanced medullary thyroid cancer (MTC']",['Vandetanib'],"['progression-free survival (PFS', 'Efficacy and Safety', 'overall survival (OS), time to worsening of pain (TWP), and objective response rate (ORR', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719914', 'cui_str': 'Zeta'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0238462', 'cui_str': 'Medullary thyroid carcinoma'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C1121849', 'cui_str': 'Vandetanib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",331.0,0.29884,"In this subgroup, results were similar in magnitude to those observed in the overall trial for PFS (hazard ratio [HR], 0.43; 95% CI, 0.28 to 0.64; P < .0001), OS (HR, 1.08; 95% CI, 0.72 to 1.61; P = .71), and TWP (HR, 0.67; 95% CI, 0.43 to 1.04; P = .07), and the observed adverse events were consistent with the known safety profile of vandetanib.","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Kreissl', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Hospital of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Clinical Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Elisei', 'Affiliation': 'Department of Clinical and Experimental Medicine, Unit of Endocrinology University of Pisa, Pisa, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Dana Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hauch', 'Affiliation': 'Hauch Consultancy, Brussels, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jarząb', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Maria Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Gliwice, Poland.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Robinson', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Colzani', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schlumberger', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Université Paris Saclay, Villejuif, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02790'] 2855,32584651,The Effect of Temporal Frames in Anti-Smoking Messages on the Extension of Anti-Smoking Arguments to Smokers.,"The present study focused on how exposure to different health message characteristics can affect extension-i.e., the sharing of arguments that were not targeted by the messages but are consistent with the message theme. In the context of anti-smoking campaigns, many messages have either emphasized reasons to quit smoking (why-quit) or ways to quit smoking (how-to-quit). Therefore, guided by construal level theory, the study aimed to examine whether the message characteristic of temporal frames can increase or decrease extension when incorporated into why-quit and how-to-quit anti-smoking messages. Results from a randomized experiment showed that exposure to why-quit messages with distant temporal frames increased extension (vs. no-message control) while why-quit messages with proximal temporal frames did not. Findings further illustrated a potential mechanism, where why-quit messages with proximal frames significantly reduced extension compared to why-quit messages with no temporal frames. Temporal frames did not have a significant effect on extension for how-to-quit messages. Results indicate that emphasizing the present in anti-smoking messages could be detrimental for the extension of why-quit arguments. Implications for applying construal level theory to health message effects research are also discussed.",2020,Temporal frames did not have a significant effect on extension for how-to-quit messages.,['Smokers'],[],[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],[],,0.0409015,Temporal frames did not have a significant effect on extension for how-to-quit messages.,"[{'ForeName': 'Stella Juhyun', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Media and Communication, Konkuk University , Seoul, Republic of Korea.'}]",Journal of health communication,['10.1080/10810730.2020.1778820'] 2856,32584698,Impact of Hypothermia on Oxygenation Variables and Metabolism in Survivors of Out-of-Hospital Cardiac Arrest Undergoing Targeted Temperature Management at 33°C Versus 36°C.,"Targeted temperature management (TTM) exerts substantial impact on hemodynamic function in out-of-hospital cardiac arrest (OHCA) patients. Whole-body oxygen consumption (VO 2 ) and delivery (DO 2 ) have not previously been investigated in a clinical setting during TTM at different levels of temperature after OHCA. A substudy of 151 patients randomized at a single center in the TTM-trial, where patients were randomly assigned TTM at 33°C (TTM33) or 36°C (TTM36) for 24 hours. We calculated VO 2 according to the principle of Fick (VO 2  = cardiac output*arteriovenous oxygen content difference). DO 2 was calculated as cardiac output*arterial oxygen content. Cardiac output was measured by pulmonary artery catheter with thermodilution. Arteriovenous oxygen content difference was calculated from arterial and mixed venous oxygen saturation and hemoglobin. Oxygen extraction ratio = VO 2 /DO 2 . At 24 hours, the VO 2 was 169 ± 59 mL O 2 per minute in TTM33 and 217 ± 53 mL O 2 per minute in TTM36 ( p  < 0.0001). During 24 hours of TTM, the overall difference was 53 mL O 2 minute (95% confidence interval [CI]: 31-74, p group < 0.0001). After rewarming at 36 and 48 hours, there was no difference in VO 2 between the groups. DO 2 was overall 277 mL O 2 per minute (95% CI: 175-379, p group < 0.0001) higher in the TTM36-group during TTM. Oxygen extraction ratio during TTM was not significantly different between the two groups (2% [95% CI: -0.1 to 5, p group  = 0.09]). VO 2 during the first 36 hours after OHCA correlated significantly with temperature, and VO 2 was 19 mL O 2 per minute lower per degree reduction in temperature (95% CI: 15-22), p  < 0.0001. TTM at 33°C compared to 36°C after OHCA is associated with significantly lower VO 2 and DO 2 , however, oxygen extraction ratio was not significantly different. For each degree lower body temperature, the VO 2 fell by 19 mL O 2 per minute.",2020,"TTM at 33°C compared to 36°C after OHCA is associated with significantly lower VO 2 and DO 2 , however, oxygen extraction ratio was not significantly different.","['out-of-hospital cardiac arrest (OHCA) patients', '151 patients randomized at a single center in the TTM-trial, where patients were randomly assigned', 'Survivors of Out-of-Hospital Cardiac Arrest Undergoing Targeted Temperature Management at 33°C Versus 36°C']","['Hypothermia', 'TTM', 'Targeted temperature management (TTM']","['Cardiac output', 'Oxygen extraction ratio\u2009=\u2009VO 2', 'hemodynamic function', 'Oxygen extraction ratio during TTM', 'cardiac output*arterial oxygen content', 'oxygen extraction ratio', 'Arteriovenous oxygen content difference']","[{'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}]","[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0429626', 'cui_str': 'Oxygen extraction ratio'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}]",151.0,0.416489,"TTM at 33°C compared to 36°C after OHCA is associated with significantly lower VO 2 and DO 2 , however, oxygen extraction ratio was not significantly different.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bro-Jeppesen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Boesgaard', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2020.0013'] 2857,32584714,Comparing open reduction and internal fixation versus closed reduction using dual-point distraction and percutaneous fixation for treating calcaneal fractures.,"OBJECTIVES This study aims to compare the early clinical, functional and radiographic outcomes of a small cohort of patients with calcaneal fractures treated with closed reduction using a dual- point distraction system and the traditional lateral approach. PATIENTS AND METHODS We prospectively treated 40 patients with calcaneus fractures who presented to our emergency department between January 2017 and February 2018. In total, 35 patients (22 males, 13 females; median age 39.8 years; range, 19 to 57 years) were included in this study since five patients were not followed up. Fractures were classified according to the Sanders classification system using computer tomography images. Clinical outcomes including postoperative two-week visual analog scale (VAS) score, sickness absence period, operating time and complication rate were recorded. RESULTS The mean follow-up period was 24 months. Closed reduction using dual-point distraction and percutaneous fixation (group 1) was performed in 17 patients, whereas the extended lateral approach (group 2) was used in 18 patients. There were no significant differences between both groups in age, follow- up outcomes and Sanders classification. Operating time was significantly shorter in group 1 than in group 2. At postoperative two weeks, VAS scores were significantly lower in group 1 than in group 2. The complication rate and sickness absence period were significantly lower in group 1 than in group 2. CONCLUSION Closed reduction using dual-point distraction can be preferred owing to many advantages including considerably decreased risk of wound complications, sickness absence period and length of hospital stay as well as superior postoperative rehabilitation with a low pain score.",2020,Operating time was significantly shorter in group 1 than in group 2.,"['35 patients (22 males, 13 females; median age 39.8 years; range, 19 to 57 years', 'We prospectively treated 40 patients with calcaneus fractures who presented to our emergency department between January 2017 and February 2018', 'patients with calcaneal fractures treated with']","['internal fixation versus closed reduction using dual-point distraction and percutaneous fixation', 'Closed reduction using dual-point distraction and percutaneous fixation', 'closed reduction using a dual- point distraction system and the traditional lateral approach']","['complication rate and sickness absence period', 'postoperative two-week visual analog scale (VAS) score, sickness absence period, operating time and complication rate', 'risk of wound complications, sickness absence period and length of hospital stay', 'Operating time', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281926', 'cui_str': 'Fracture of calcaneus'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441551', 'cui_str': 'Percutaneous fixation of bone'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",5.0,0.0164485,Operating time was significantly shorter in group 1 than in group 2.,"[{'ForeName': 'Sefa Giray', 'Initials': 'SG', 'LastName': 'Batıbay', 'Affiliation': ''}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bayram', 'Affiliation': 'İstanbul Üniversitesi İstanbul Tıp Fakültesi Ortopedi ve Travmatoloji Anabilim Dalı, 34093 Çapa, Fatih, İstanbul, Türkiye. dr.serkanbayram89@gmail.com.'}]",Joint diseases and related surgery,['10.5606/ehc.2020.72236'] 2858,32584707,"Pride in all Who Served: Development, Feasibility, and Initial Efficacy of a Health Education Group For LGBT Veterans.","Many of the more than 1 million military veterans who identify as lesbian, gay, bisexual, and/or transgender (LGBT) have encountered ""rejecting experiences in the military"" and stigma from prior ""Don't Ask Don't Tell"" policies. Associated minority stress and social isolation have been linked to a disproportionate risk for depression and suicide, as well as a reluctance to seek medical care at Veterans Health Administration (VHA) facilities. This paper describes feasibility and preliminary outcomes of the newly developed, Pride in All Who Served Health Education Group created to meet the unique needs of sexual and gender minority veterans. The 10-week, closed, health education group (e.g., continuums of identity, military culture) enables open dialogue, fosters social connectedness, and empowers veterans to be more effective self-advocates within the healthcare system. Feedback from formative evaluations ( n = 29 LGBT veterans and n = 25 VHA stakeholders) was incorporated before conducting a small scale, non-randomized pilot. Preliminary pre-post surveys (n  = 18) show promise (i.e., Cohen's d range ± 0.40 to 1.59) on mental health symptoms (depression/anxiety, suicidal ideation), resilience indicators (identity affirmation, community involvement, problem-focused coping), and willingness to access care within the VA system (satisfaction with VA services, perception of staff competence). Results suggest that the 10-week Pride Group may be an effective tool for addressing minority-related stress in LGBT veterans. A full-scale, randomized clinical trial of this intervention is needed to determine short and long-term impacts on clinical and healthcare access-related outcomes.",2020,Results suggest that the 10-week Pride Group may be an effective tool for addressing minority-related stress in LGBT veterans.,"['Who Served', 'Group For LGBT Veterans']",['Health Education'],"['Development, Feasibility, and Initial Efficacy', 'mental health symptoms (depression/anxiety, suicidal ideation), resilience indicators (identity affirmation, community involvement, problem-focused coping), and willingness to access care within the VA system (satisfaction with VA services, perception of staff competence']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0009476', 'cui_str': 'Community Involvement'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0257599,Results suggest that the 10-week Pride Group may be an effective tool for addressing minority-related stress in LGBT veterans.,"[{'ForeName': 'Tiffany M', 'Initials': 'TM', 'LastName': 'Lange', 'Affiliation': 'Office of the Associate Director, Hampton VA Medical Center , Hampton, VA, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Hilgeman', 'Affiliation': 'Research and Development Service, Tuscaloosa VA Medical Center , Tuscaloosa, AL, USA.'}, {'ForeName': 'Kaitlin J', 'Initials': 'KJ', 'LastName': 'Portz', 'Affiliation': 'Siteman Cancer Center, Siteman Psychology Service, Barnes-Jewish Hospital , St. Louis, MO, USA.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Intoccia', 'Affiliation': 'Research and Development Service, Tuscaloosa VA Medical Center , Tuscaloosa, AL, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Cramer', 'Affiliation': 'Department of Public Health Sciences, University of North Carolina at Charlotte , Charlotte, NC, USA.'}]",Journal of trauma & dissociation : the official journal of the International Society for the Study of Dissociation (ISSD),['10.1080/15299732.2020.1770147'] 2859,32584754,Communication Cues and Engagement Behavior: Identifying Advertisement Strategies to Attract Middle-Aged Adults to a Study of the Chronic Disease Self-Management Program.,"INTRODUCTION Low- and middle-income, middle-aged adults have high rates of disease and death from chronic disease, yet their participation in self-management programs is low. This may be because advertisements for such programs often target elderly, predominantly white, affluent adults. Our study used data from a parent randomized controlled trial to identify theoretically driven advertisement cues to engage low- and middle-income, middle-aged adults in the Chronic Disease Self-Management Program (CDSMP). METHODS A framework that combined the Elaboration Likelihood Model and Protection Motivation Theory was used to guide χ 2 and regression analyses to assess relationships between advertisement cue preferences and 5 stages of cognitive engagement (cue processing, cognitive appraisal of the advertised study, motivation to enroll) and behavioral engagement of study participants (enrollment and program participation). RESULTS One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing. CONCLUSION These results can inform CDSMP recruitment efforts to better engage low- and middle-income, middle-aged adults in an effort to mitigate the disproportionate burden of chronic disease in this population.",2020,"RESULTS One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing. ","['middle-aged adults in the Chronic Disease Self-Management Program (CDSMP', 'Attract Middle-Aged Adults']",[],[],"[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],[],,0.030059,"RESULTS One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing. ","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Horrell', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, North Carolina.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Knafl', 'Affiliation': 'University of North Carolina at Chapel Hill, School of Nursing, Chapel Hill, North Carolina.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Brady', 'Affiliation': 'Clarity Consulting and Communications, Atlanta, Georgia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Lazard', 'Affiliation': 'University of North Carolina at Chapel Hill, Hussman School of Journalism and Media, Chapel Hill, North Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linnan', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, North Carolina.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kneipp', 'Affiliation': 'University of North Carolina at Chapel Hill, School of Nursing, Chapel Hill, North Carolina.'}]",Preventing chronic disease,['10.5888/pcd17.190413'] 2860,32584828,Potentials and pitfalls of increasing prosocial behavior and self-efficacy over time using an online personalized platform.,"BACKGROUND This longitudinal mixed methods experimental study aimed to better understand the interplay between digital technology exposure over time, self-efficacy, and prosocial behavior in everyday contexts. METHODS 66 psychology students tracked their daily prosocial behavior over three weeks. Additionally, half of the participants were randomly assigned to receive access to an online platform, which made personalized suggestions for prosocial actions to complete. Qualitative post-study interviews complemented quantitative measures. RESULTS Platform exposure had no measurable impact beyond that of tracking over time on either prosocial behavior or self-efficacy. Tracking increased self-efficacy to perform everyday prosocial actions, but did not affect self-efficacy to impact change. Prosocial behavior was predicted by self-efficacy to impact change. Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future. Avenues for increasing platform effectiveness include context-specific action personalization, an effective reminder system, and better support for the development of self-efficacy to impact change through meaningful actions. CONCLUSION Technology for prosocial behavior should be enjoyable, capable of being seamlessly integrated into everyday life, and ensure that suggested actions are perceived as meaningful in order to support the sustainable development of self-efficacy and prosocial behavior over time.",2020,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,['66 psychology students tracked their'],[],"['prosocial behavior and self-efficacy', 'daily prosocial behavior', 'prosocial behavior or self-efficacy', 'self-efficacy', 'Prosocial behavior']","[{'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0040594', 'cui_str': 'Track'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",66.0,0.025428,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,"[{'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Steinemann', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Geelan', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zaehringer', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Kamalatharsi', 'Initials': 'K', 'LastName': 'Mutuura', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Ewgenij', 'Initials': 'E', 'LastName': 'Wolkow', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frasseck', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Opwis', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}]",PloS one,['10.1371/journal.pone.0234422'] 2861,32584834,Gender-differences in predictors for time to metabolic syndrome resolution: A secondary analysis of a randomized controlled trial study.,"Understanding gender differences in health-related behaviors and their impacts is a crucial aspect of effective primary care. We studied gender-based differences in predictors of metabolic syndrome (MetS) resolution among newly diagnosed MetS patients. This study was a secondary analysis of a prospective clinical trial study comprising of 637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces. We conducted Cox proportional hazard analysis to estimate cumulative probability of MetS resolution within a 12-month observation period. Among the 637 patients, 47.6% of participants achieved MetS resolution. The resolution rate was similar among men and women (44.7% and 49.1%, respectively, P = 0.320). Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women. For women, however, longer sleeping hours (1.18, 1.04-1.34) and living with a partner (1.58, 1.06-2.35) were positive predictors of MetS resolution. Being overweight (0.63, 0.44-0.89) was associated with lower cumulative probability of MetS resolution in women than in men. The factors associated with cumulative probability of MetS resolution within the 12-month follow-up were different between men and women. These findings facilitate further exploration on gender-based differences in risk factors for less optimal improvements in MetS.",2020,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","['637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces', 'newly diagnosed MetS patients']",[],"['metabolic syndrome (MetS) resolution', 'current employment', 'cumulative probability of MetS resolution', 'MetS resolution', 'resolution rate']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",637.0,0.231571,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","[{'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Choe', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, CHA University, Gyunggi-do, Republic of Korea.'}, {'ForeName': 'Nan-He', 'Initials': 'NH', 'LastName': 'Yoon', 'Affiliation': 'Department of Health Administration, Hanyang Cyber University, Seoul, Republic of Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyekyeong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Health Convergence, Ewha Womans University, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0234035'] 2862,32584881,"Effect of maternal prenatal food supplementation, gestational weight gain, and breast-feeding on infant growth during the first 24 months of life in rural Vietnam.","Growth faltering among children during the first five years of life is a common problem among low and middle-income countries. The purpose of this study was to determine the effect of a nutrient-rich, food-based supplement given to Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth. This prospective cohort study included 236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial. Infant anthropometry and feeding information were monitored monthly and the infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ) were assessed at 6, 12, 18, and 24 months of age using mixed-effects regression modeling. Compared to the non-supplemented mothers, infants born to mothers receiving food supplementation from mid-gestation to term had significantly higher WLZ only at 18 months (p = 0.03) and did not differ in other outcomes. Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months. In the entire study cohort, maternal height and gestational weight gain were positively associated with the infant's WAZ and LAZ from 6 to 24 months of age. Programs designed to improve gestational weight gain among women performing demanding physical work throughout a reproductive cycle may improve postnatal infant growth. Trial registration: Registered Clinical Trials.Gov: NCT01235767.",2020,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"['236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial', 'rural Vietnam', ""Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth""]","['maternal prenatal food supplementation, gestational weight gain, and breast-feeding', 'nutrient-rich, food-based supplement']","['maternal height and gestational weight gain', 'infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ', 'WLZ', 'gestational weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",236.0,0.0761669,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"[{'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}]",PloS one,['10.1371/journal.pone.0233671'] 2863,32584893,Effectiveness of a digital device providing real-time visualized tooth brushing instructions: A randomized controlled trial.,"INTRODUCTION The aim of this trial was to investigate whether a digital device that provides real-time visualized brushing instructions would contribute to the removal of dental plaque over usual brushing instructions. METHODS We conducted a single-center, parallel-group, stratified permuted block randomized control trial with 1:1 allocation ratio. Eligibility criteria included people aged ≥ 18 years, and exclude people who met the following criteria: severely crowded teeth; using interdental cleaning implement; having external injury in the oral cavity, or stomatitis; having less than 20 teeth; using orthodontic apparatus; visited to a dental clinic; having the possibility of consulting a dental clinic; having a dental license; not owning a smartphone or tablet device; smoker; taken antibiotics; pregnant; an allergy to the staining fluid; and employee of Sunstar Inc. All participants received tooth brushing instructions using video materials and were randomly assigned to one of two groups for four weeks: (1) an intervention group who used the digital device, providing real-time visualized instructions by connection with a mobile application; and (2) a control group that used a digital device which only collected their brushing logs. The primary outcome was the change in 6-point method plaque control record (PCR) score of all teeth between baseline and week 4. The t-test was used to compare the two groups in accordance with intention-to-treat principles. RESULTS Among 118 enrolled individuals, 112 participants were eligible for our analyses. The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07). CONCLUSIONS A digital device providing real-time visualized brushing instructions may be effective for the removal of dental plaque.",2020,"The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07). ","['118 enrolled individuals', '112 participants were eligible for our analyses', 'Eligibility criteria included people aged ≥ 18 years, and exclude people who met the following criteria: severely crowded teeth; using interdental cleaning implement; having external injury in the oral cavity, or stomatitis; having less than 20 teeth; using orthodontic apparatus; visited to a dental clinic; having the possibility of consulting a dental clinic; having a dental license; not owning a smartphone or tablet device; smoker; taken antibiotics; pregnant; an allergy to the staining fluid; and employee of Sunstar Inc']","['intervention group who used the digital device, providing real-time visualized instructions by connection with a mobile application; and (2) a control group that used a digital device which only collected their brushing logs', 'digital device providing real-time visualized tooth brushing instructions']","['change in 6-point method plaque control record (PCR) score of all teeth', 'mean of PCR score', 'change of PCR score']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040433', 'cui_str': 'Crowding of teeth'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0443212', 'cui_str': 'External injury'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",118.0,0.27291,"The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07). ","[{'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Shida', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Satoe', 'Initials': 'S', 'LastName': 'Okabayashi', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Oral Health Sciences, Faculty of Health and Welfare, Tokushima Bunri University, Tokushima, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishiura', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Okazawa', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kiyohara', 'Affiliation': ""Department of Food Science, Otsuma Women's University, Tokyo, Japan.""}, {'ForeName': 'Manako', 'Initials': 'M', 'LastName': 'Konda', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Nishioka', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Iwami', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}]",PloS one,['10.1371/journal.pone.0235194'] 2864,32584909,Machine learning insight into the role of imaging and clinical variables for the prediction of obstructive coronary artery disease and revascularization: An exploratory analysis of the CONSERVE study.,"BACKGROUND Machine learning (ML) is able to extract patterns and develop algorithms to construct data-driven models. We use ML models to gain insight into the relative importance of variables to predict obstructive coronary artery disease (CAD) using the Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE) study, as well as to compare prediction of obstructive CAD to the CAD consortium clinical score (CAD2). We further perform ML analysis to gain insight into the role of imaging and clinical variables for revascularization. METHODS For prediction of obstructive CAD, the entire ICA arm of the study, comprising 719 patients was used. For revascularization, 1,028 patients were randomized to invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA). Data was randomly split into 80% training 20% test sets for building and validation. Models used extreme gradient boosting (XGBoost). RESULTS Mean age was 60.6 ± 11.5 years and 64.3% were female. For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798]) (P = 0.01). BMI, age, and angina severity were the most important variables. For revascularization, the model obtained an overall area under the receiver-operation curve (AUC) of 0.958 (95% CI = 0.933-0.983). Performance did not differ whether the imaging parameters used were from ICA (AUC 0.947, 95% CI = 0.903-0.990) or CCTA (AUC 0.941, 95% CI = 0.895-0.988) (P = 0.90). The ML model obtained sensitivity and specificity of 89.2% and 92.9%, respectively. Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI) were the most important variables. Exclusion of imaging variables resulted in performance deterioration, with an AUC of 0.705 (95% CI 0.614-0.795) (P <0.0001). CONCLUSIONS For obstructive CAD, the ML model outperformed CAD2. BMI is an important variable, although currently not included in most scores. In this ML model, imaging variables were most associated with revascularization. Imaging modality did not influence model performance. Removal of imaging variables reduced model performance.",2020,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","['1,028 patients were randomized to', 'Mean age was 60.6 ± 11.5 years and 64.3% were female', 'obstructive coronary artery disease and revascularization', '719 patients was used']","['Machine learning (ML', 'invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA', 'Coronary Computed Tomographic Angiography']","['Performance', 'BMI', 'Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI', 'BMI, age, and angina severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}]",1028.0,0.0893556,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","[{'ForeName': 'Lohendran', 'Initials': 'L', 'LastName': 'Baskaran', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Zhuoran', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Subhi J', 'Initials': 'SJ', 'LastName': ""Al'Aref"", 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Sang-Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Danad', 'Affiliation': 'VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hyung-Bok', 'Initials': 'HB', 'LastName': 'Park', 'Affiliation': 'Myongji Hospital, Seonam University College of Medicine, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Bathina', 'Affiliation': 'CARE Hospital and FACTS Foundation, Hyderabad, India.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baggiano', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Beltrama', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cerci', 'Affiliation': 'Quanta Diagnostico Nuclear, Curitiba, Brazil.'}, {'ForeName': 'Eui-Young', 'Initials': 'EY', 'LastName': 'Choi', 'Affiliation': 'Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Hyun', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Cardiology Associates of Mobile, Mobile, Alabama, United States of America.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Inje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Ha', 'Affiliation': 'Gangneung Asan Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kepka', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Jang-Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Wonju Severance Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Jin-Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University Hospital, Seoul, South Korea.'}, {'ForeName': 'Woong', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Yeungnam University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Heo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ji-Min', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Valeti', 'Affiliation': 'Department of Medicine, Stanford Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Donghee', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Imaging, Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, California, United States of America.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Hyuk-Jae', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0233791'] 2865,32584935,Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial.,"Importance The incidence of gallstones has been reported to increase after gastrectomy. However, few studies have been conducted on the prevention of gallstone formation in patients who have undergone gastrectomy. Objective To evaluate the efficacy and safety of ursodeoxycholic acid (UDCA) in preventing gallstone formation after gastrectomy in patients with gastric cancer. Design, Setting, and Participants The PEGASUS-D study (Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study) was a randomized, double-blind, placebo-controlled clinical trial conducted at 12 institutions in the Republic of Korea. Adults (aged ≥19 years) with a diagnosis of gastric cancer who underwent total, distal, or proximal gastrectomy were enrolled between May 26, 2015, and January 9, 2017; follow-up ended January 8, 2018. Efficacy was evaluated by both the full analysis set, based on the intention-to-treat principle, and the per-protocol set; full analysis set findings were interpreted as the main results. Interventions Eligible participants were randomly assigned to receive 300 mg of UDCA, 600 mg of UDCA, or placebo at a ratio of 1:1:1. Ursodeoxycholic acid and placebo were administered daily for 52 weeks. Main Outcomes and Measures Gallstone formation was assessed with abdominal ultrasonography every 3 months for 12 months. Randomization and allocation to trial groups were carried out by an interactive web-response system. The primary end point was the proportion of patients developing gallstones within 12 months after gastrectomy. Results A total of 521 patients (175 received 300 mg of UDCA, 178 received 600 mg of UDCA, and 168 received placebo) were randomized. The full analysis set included 465 patients (311 men; median age, 56.0 years [interquartile range, 48.0-64.0 years]), with 151 patients in the 300-mg group, 164 patients in the 600-mg group, and 150 patients in the placebo group. The proportion of patients developing gallstones within 12 months after gastrectomy was 8 of 151 (5.3%) in the 300-mg group, 7 of 164 (4.3%) in the 600-mg group, and 25 of 150 (16.7%) in the placebo group. Compared with the placebo group, odds ratios for gallstone formation were 0.27 (95% CI, 0.12-0.62; P = .002) in the 300-mg group and 0.20 (95% CI, 0.08-0.50; P < .001) in the 600-mg group. No significant adverse drug reactions were detected among the enrolled patients. Conclusions and Relevance Administration of UDCA for 12 months significantly reduced the incidence of gallstones after gastrectomy for gastric cancer. These findings suggest that UDCA administration prevents gallstone formation after gastrectomy in patients with gastric cancer. Trial Registration ClinicalTrials.gov Identifier: NCT02490111.",2020,"Compared with the placebo group, odds ratios for gallstone formation were 0.27 (95% CI, 0.12-0.62; P = .002) in the 300-mg group and 0.20 (95% CI, 0.08-0.50; P < .001) in the 600-mg group.","['patients with gastric cancer', '521 patients (175 received 300 mg of', 'patients who have undergone gastrectomy', 'Adults (aged ≥19 years) with a diagnosis of gastric cancer who underwent total, distal, or proximal gastrectomy were enrolled between May 26, 2015, and January 9, 2017; follow-up ended January 8, 2018', '465 patients (311 men; median age, 56.0 years [interquartile range, 48.0-64.0 years]), with 151 patients in the 300-mg group, 164 patients in the 600-mg group, and 150 patients in the placebo group', 'Patients With Gastric Cancer', 'Interventions\n\n\nEligible participants', '12 institutions in the Republic of Korea', 'Patient with Gastric Cancer']","['Ursodeoxycholic Acid', 'ursodeoxycholic acid (UDCA', 'UDCA, 600 mg of UDCA, or placebo', 'Placebo', 'Ursodeoxycholic acid and placebo', 'UDCA', 'placebo']","['Gallstone Formation', 'adverse drug reactions', 'gallstone formation', 'Measures\n\n\nGallstone formation', 'odds ratios for gallstone formation', 'Efficacy', 'incidence of gallstones', 'proportion of patients developing gallstones']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0399713', 'cui_str': 'Proximal subtotal gastrectomy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",521.0,0.51093,"Compared with the placebo group, odds ratios for gallstone formation were 0.27 (95% CI, 0.12-0.62; P = .002) in the 300-mg group and 0.20 (95% CI, 0.08-0.50; P < .001) in the 600-mg group.","[{'ForeName': 'Sang Hyub', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Kee', 'Initials': 'DK', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Moon-Won', 'Initials': 'MW', 'LastName': 'Yoo', 'Affiliation': 'Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sun-Hwi', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.'}, {'ForeName': 'Seong-Yeob', 'Initials': 'SY', 'LastName': 'Ryu', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, Republic of Korea.'}, {'ForeName': 'Oh Kyoung', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery, Kyoungpook National University Chilgok Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Hur', 'Affiliation': 'Department of Surgery, Ajou University Hospital, Suwon, Republic of Korea.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Man Yoon', 'Affiliation': 'Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Bang Wool', 'Initials': 'BW', 'LastName': 'Eom', 'Affiliation': 'Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Hye Seong', 'Initials': 'HS', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Taeil', 'Initials': 'T', 'LastName': 'Son', 'Affiliation': 'Department of Surgery, Yonsei University Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyo Young', 'Initials': 'KY', 'LastName': 'Song', 'Affiliation': ""Department of Surgery, Catholic University of Seoul St Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Han Hong', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Catholic University of Seoul St Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Min-Gew', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Kyung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Do Joong', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.1501'] 2866,32584973,Persistent and emerging pneumococcal carriage serotypes in a rural Gambian community after ten years of pneumococcal conjugate vaccine pressure.,"BACKGROUND The continuing impact of pneumococcal conjugate vaccines (PCVs) in regions with high pneumococcal transmission is threatened by the persistence of vaccine serotypes (VT) and the emergence of non-vaccine serotypes (NVT). METHODS In 2016, we conducted a cross-sectional carriage survey (CSS5) in a community where PCV7 was first introduced in 2006 during a cluster randomised trial conducted before nationwide introduction of PCV7 (2009) and PCV13 (2011). We estimated the prevalence of PCV13 VT and NVT by age and compared these to earlier surveys before (CSS0), during (CSS1-3), and after the trial but before PCV13 (CSS4). Genomic analysis was conducted for the non-typeable pneumococci. RESULTS The prevalence of PCV13 VT carriage decreased during the 10 years between CSS0 and CSS5 across all age groups (67·6% to 13·5%, p<0.001; 59·8% to 14·4%, p<0.001; 43·1% to 17·9%, p<0.001; and 24·0% to 5·1%, p<0.001 in <2, 2-4, 5-14 and ≥15 years respectively). However, there was no difference between CSS4 and CSS5 in children ≥2 years and adults (children < 2 years, no data). The prevalence of PCV13 NVT increased between CSS0 and CSS5 for children <2 years but decreased in older children and adults.In CSS5, serotypes 3, 6A and 19F were the most common VT and non-typeable isolates, the most common NVT. Among non-typeable isolates, 73·0% lost the ability to express a capsule. Of these, 70·8% were from a VT background. CONCLUSIONS The decrease in PCV13 VT that has occurred since the introduction of PCV13 appears to have plateaued. Significant carriage of these serotypes remains in all age groups.",2020,"The prevalence of PCV13 VT carriage decreased during the 10 years between CSS0 and CSS5 across all age groups (67·6% to 13·5%, p<0.001; 59·8% to 14·4%, p<0.001; 43·1% to 17·9%, p<0.001; and 24·0% to 5·1%, p<0.001 in <2, 2-4, 5-14 and ≥15 years respectively).","['rural Gambian community after ten years of pneumococcal conjugate vaccine pressure', 'children ≥2 years and adults (children < 2 years, no data']","['pneumococcal conjugate vaccines (PCVs', 'CSS0 and CSS5', 'PCV7 (2009) and PCV13', 'CSS4 and CSS5']","['prevalence of PCV13 VT carriage', 'PCV13 NVT']","[{'cui': 'C0337833', 'cui_str': 'Gambians'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C0979582', 'cui_str': 'Pneumococcal 7-valent conjugate vaccine'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0892875,"The prevalence of PCV13 VT carriage decreased during the 10 years between CSS0 and CSS5 across all age groups (67·6% to 13·5%, p<0.001; 59·8% to 14·4%, p<0.001; 43·1% to 17·9%, p<0.001; and 24·0% to 5·1%, p<0.001 in <2, 2-4, 5-14 and ≥15 years respectively).","[{'ForeName': 'Effua', 'Initials': 'E', 'LastName': 'Usuf', 'Affiliation': 'Disease Control and Elimination Theme, Medical Research Council Unit The Gambia at London School Hygiene and Tropical Medicine, Fajara The Gambia.'}, {'ForeName': 'Bottomley', 'Initials': 'B', 'LastName': 'Christian', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gladstone', 'Affiliation': 'Wellcome Sanger Institute, Cambridge UK.'}, {'ForeName': 'Ebrima', 'Initials': 'E', 'LastName': 'Bojang', 'Affiliation': 'Disease Control and Elimination Theme, Medical Research Council Unit The Gambia at London School Hygiene and Tropical Medicine, Fajara The Gambia.'}, {'ForeName': 'Kaddijatou', 'Initials': 'K', 'LastName': 'Jawneh', 'Affiliation': 'Disease Control and Elimination Theme, Medical Research Council Unit The Gambia at London School Hygiene and Tropical Medicine, Fajara The Gambia.'}, {'ForeName': 'Isatou', 'Initials': 'I', 'LastName': 'Cox', 'Affiliation': 'Disease Control and Elimination Theme, Medical Research Council Unit The Gambia at London School Hygiene and Tropical Medicine, Fajara The Gambia.'}, {'ForeName': 'Edrissa', 'Initials': 'E', 'LastName': 'Jallow', 'Affiliation': 'Disease Control and Elimination Theme, Medical Research Council Unit The Gambia at London School Hygiene and Tropical Medicine, Fajara The Gambia.'}, {'ForeName': 'Abdoulie', 'Initials': 'A', 'LastName': 'Bojang', 'Affiliation': 'Disease Control and Elimination Theme, Medical Research Council Unit The Gambia at London School Hygiene and Tropical Medicine, Fajara The Gambia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London UK.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Adegbola', 'Affiliation': 'RAMBICON, Immunisation & Global Health Consulting, Lekki, Lagos, Nigeria.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Bentley', 'Affiliation': 'Wellcome Sanger Institute, Cambridge UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Hill', 'Affiliation': 'Centre for Global Health, Otago University, Otago New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roca', 'Affiliation': 'Disease Control and Elimination Theme, Medical Research Council Unit The Gambia at London School Hygiene and Tropical Medicine, Fajara The Gambia.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa856'] 2867,32584979,Screening for cardiovascular disease risk using traditional risk factor assessment or coronary artery calcium scoring: the ROBINSCA trial.,"AIMS Screening for a high cardiovascular disease (CVD) risk followed by preventive treatment can potentially reduce coronary heart disease-related morbidity and mortality. ROBINSCA (Risk Or Benefit IN Screening for CArdiovascular disease) is a population-based randomized controlled screening trial that investigates the effectiveness of CVD screening in asymptomatic participants using the Systematic COronary Risk Evaluation (SCORE) model or coronary artery calcium (CAC) scoring. This study describes the distributions in risk and treatment in the ROBINSCA trial. METHODS AND RESULTS Individuals at expected elevated CVD risk were randomized into screening arm A (n = 14 478; SCORE, 10-year fatal and non-fatal risk); or screening arm B (n = 14 450; CAC scoring). Preventive treatment was largely advised according to current Dutch guidelines. Risk and treatment differences between the screening arms were analysed. A total of 12 185 participants (84.2%) in arm A and 12 950 (89.6%) in arm B were screened. In total, 48.7% were women, and median age was 62 (interquartile range 10) years. SCORE screening identified 45.1% at low risk (SCORE < 10%), 26.5% at intermediate risk (SCORE 10-20%), and 28.4% at high risk (SCORE ≥ 20%). According to CAC screening, 76.0% were at low risk (Agatston < 100), 15.1% at high risk (Agatston 100-399), and 8.9% at very high risk (Agatston ≥ 400). CAC scoring significantly reduced the number of individuals indicated for preventive treatment compared to SCORE (relative reduction women: 37.2%; men: 28.8%). CONCLUSION We showed that compared to risk stratification based on SCORE, CAC scoring classified significantly fewer men and women at increased risk, and less preventive treatment was indicated. TRIAL REGISTRATION NUMBER NTR6471.",2020,"CAC scoring significantly reduced the number of individuals indicated for preventive treatment compared to SCORE (relative reduction women: 37.2%; men: 28.8%). ","['A total of 12\xa0185 participants (84.2%) in arm A and 12\xa0950 (89.6%) in arm B were screened', 'Individuals at expected elevated CVD risk', 'asymptomatic participants using the Systematic COronary Risk Evaluation (SCORE) model or coronary artery calcium', 'In total, 48.7% were women, and median age was 62 (interquartile range 10) years']",['traditional risk factor assessment or coronary artery calcium scoring'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2825178', 'cui_str': 'Coronary artery calcium score'}]",[],12185.0,0.105418,"CAC scoring significantly reduced the number of individuals indicated for preventive treatment compared to SCORE (relative reduction women: 37.2%; men: 28.8%). ","[{'ForeName': 'Carlijn M', 'Initials': 'CM', 'LastName': 'van der Aalst', 'Affiliation': 'Department of Public Health, Erasmus Medical Centre, PO Box 2040, 3000 CA Rotterdam, The Netherlands.'}, {'ForeName': 'Sabine J A M', 'Initials': 'SJAM', 'LastName': 'Denissen', 'Affiliation': 'Department of Public Health, Erasmus Medical Centre, PO Box 2040, 3000 CA Rotterdam, The Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Vonder', 'Affiliation': 'Centre for Medical Imaging North-East Netherlands (CMI-NEN), University Medical Centre Groningen, Hanzeplein 1, EB45, Groningen 9713 GZ, The Netherlands.'}, {'ForeName': 'Jan Willem C', 'Initials': 'JWC', 'LastName': 'Gratama', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Gelre Hospitals, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands.'}, {'ForeName': 'Henk J', 'Initials': 'HJ', 'LastName': 'Adriaansen', 'Affiliation': 'Department of Clinical Chemistry and Hematology Laboratory, Gelre Hospitals, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands.'}, {'ForeName': 'Dirkjan', 'Initials': 'D', 'LastName': 'Kuijpers', 'Affiliation': 'Department of Radiology, University Medical Centre Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'Centre for Medical Imaging North-East Netherlands (CMI-NEN), University Medical Centre Groningen, Hanzeplein 1, EB45, Groningen 9713 GZ, The Netherlands.'}, {'ForeName': 'Jeanine E Roeters', 'Initials': 'JER', 'LastName': 'van Lennep', 'Affiliation': 'Department of Internal Medicine, Erasmus Medical Centre, Doctor Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'Centre for Medical Imaging North-East Netherlands (CMI-NEN), University Medical Centre Groningen, Hanzeplein 1, EB45, Groningen 9713 GZ, The Netherlands.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Braam', 'Affiliation': 'Department of Cardiology, Gelre Hospitals, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands.'}, {'ForeName': 'Paul R M', 'Initials': 'PRM', 'LastName': 'van Dijkman', 'Affiliation': 'Department of Cardiology, Leids University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Rykel', 'Initials': 'R', 'LastName': 'van Bruggen', 'Affiliation': 'General practice, Arnhemseweg 2 A, 7331 BK Apeldoorn, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus Medical Centre, PO Box 2040, 3000 CA Rotterdam, The Netherlands.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jeaa168'] 2868,32584996,Safety and efficacy of 48 and 96 weeks of alendronate in children and adolescents with perinatal HIV infection and low bone mineral density for age.,"No safety concerns were identified in a randomized, crossover study of alendronate/placebo in youth with perinatal HIV-infection and low bone mineral density (BMD). BMD improved with 48 weeks of alendronate and continued to improve with an additional 48 weeks of therapy. Gains were largely maintained 48 weeks after stopping alendronate.",2020,"No safety concerns were identified in a randomized, crossover study of alendronate/placebo in youth with perinatal HIV-infection and low bone mineral density (BMD).","['children and adolescents with perinatal HIV infection and low bone mineral density for age', 'youth with perinatal HIV-infection and low bone mineral density (BMD']","['alendronate/placebo', 'alendronate']","['Safety and efficacy', 'BMD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3160847', 'cui_str': 'Perinatal HIV infection'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.0872012,"No safety concerns were identified in a randomized, crossover study of alendronate/placebo in youth with perinatal HIV-infection and low bone mineral density (BMD).","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Lindsey', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, United States.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Jacobson', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, United States.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Rockville, MD, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Gordon', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hazra', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Division of Extramural Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, Department of Health and Human Services, Bethesda, United States.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'Office of HIV/AIDS, United States Agency for International Development, Washington, DC, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa861'] 2869,32585017,Maternal Sildenafil vs Placebo in Pregnant Women With Severe Early-Onset Fetal Growth Restriction: A Randomized Clinical Trial.,"Importance Severe early onset fetal growth restriction caused by placental dysfunction leads to high rates of perinatal mortality and neonatal morbidity. The phosphodiesterase 5 inhibitor, sildenafil, inhibits cyclic guanosine monophosphate hydrolysis, thereby activating the effects of nitric oxide, and might improve uteroplacental function and subsequent perinatal outcomes. Objective To determine whether sildenafil reduces perinatal mortality or major morbidity. Design, Setting, and Participants This placebo-controlled randomized clinical trial was conducted at 10 tertiary referral centers and 1 general hospital in the Netherlands from January 20, 2015, to July 16, 2018. Participants included pregnant women between 20 and 30 weeks of gestation with severe fetal growth restriction, defined as fetal abdominal circumference below the third percentile or estimated fetal weight below the fifth percentile combined with Dopplers measurements outside reference ranges or a maternal hypertensive disorder. The trial was stopped early owing to safety concerns on July 19, 2018, whereas benefit on the primary outcome was unlikely. Data were analyzed from January 20, 2015, to January 18, 2019. The prespecified primary analysis was an intention-to-treat analysis including all randomized participants. Interventions Participants were randomized to sildenafil, 25 mg, 3 times a day vs placebo. Main Outcomes and Measures The primary outcome was a composite of perinatal mortality or major neonatal morbidity until hospital discharge. Results Out of 360 planned participants, a total of 216 pregnant women were included, with 108 women randomized to sildenafil (median gestational age at randomization, 24 weeks 5 days [interquartile range, 23 weeks 3 days to 25 weeks 5 days]; mean [SD] estimated fetal weight, 458 [160] g) and 108 women randomized to placebo (median gestational age, 25 weeks 0 days [interquartile range, 22 weeks 5 days to 26 weeks 3 days]; mean [SD] estimated fetal weight, 464 [186] g). In July 2018, the trial was halted owing to concerns that sildenafil may cause neonatal pulmonary hypertension, whereas benefit on the primary outcome was unlikely. The primary outcome, perinatal mortality or major neonatal morbidity, occurred in the offspring of 65 participants (60.2%) allocated to sildenafil vs 58 participants (54.2%) allocated to placebo (relative risk, 1.11; 95% CI, 0.88-1.40; P = .38). Pulmonary hypertension, a predefined outcome important for monitoring safety, occurred in 16 neonates (18.8%) in the sildenafil group vs 4 neonates (5.1%) in the placebo group (relative risk, 3.67; 95% CI, 1.28-10.51; P = .008). Conclusions and Relevance These findings suggest that antenatal maternal sildenafil administration for severe early onset fetal growth restriction did not reduce the risk of perinatal mortality or major neonatal morbidity. The results suggest that sildenafil may increase the risk of neonatal pulmonary hypertension. Trial Registration ClinicalTrials.gov Identifier: NCT02277132.",2020,"Pulmonary hypertension, a predefined outcome important for monitoring safety, occurred in 16 neonates (18.8%) in the sildenafil group vs 4 neonates (5.1%) in the placebo group (relative risk, 3.67; 95% CI, 1.28-10.51; P = .008). ","['360 planned participants', '216 pregnant women were included, with 108 women randomized to', 'Participants included pregnant women between 20 and 30 weeks of gestation with severe fetal growth restriction, defined as fetal abdominal circumference below the third percentile or estimated fetal weight below the fifth percentile combined with Dopplers measurements outside reference ranges or a maternal hypertensive disorder', '10 tertiary referral centers and 1 general hospital in the Netherlands from January 20, 2015, to July 16, 2018', 'Pregnant Women With Severe Early-Onset Fetal Growth Restriction']","['placebo', 'antenatal maternal sildenafil', 'Maternal Sildenafil vs Placebo', 'sildenafil']","['perinatal mortality or major morbidity', 'perinatal mortality and neonatal morbidity', 'risk of neonatal pulmonary hypertension', 'composite of perinatal mortality or major neonatal morbidity until hospital discharge', 'neonatal pulmonary hypertension', 'risk of perinatal mortality or major neonatal morbidity', 'perinatal mortality or major neonatal morbidity', 'Pulmonary hypertension']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C1299357', 'cui_str': 'Fifth percentile'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1273511', 'cui_str': 'Outside reference range'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",216.0,0.6869,"Pulmonary hypertension, a predefined outcome important for monitoring safety, occurred in 16 neonates (18.8%) in the sildenafil group vs 4 neonates (5.1%) in the placebo group (relative risk, 3.67; 95% CI, 1.28-10.51; P = .008). ","[{'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Pels', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Derks', 'Affiliation': ""Wilhelmina Children's Hospital, Department of Obstetrics, University Medical Center Utrecht, Gynecology and Neonatology, Utrecht, the Netherlands.""}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Elvan-Taspinar', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'van Drongelen', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'de Boer', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Duvekot', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'van Laar', 'Affiliation': 'Department of Obstetrics and Gynecology, Maxima Medical Center, Veldhoven, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Eyck', 'Affiliation': 'Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Salwan', 'Initials': 'S', 'LastName': 'Al-Nasiry', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Sueters', 'Affiliation': 'Department of Obstetrics and Gynecology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marinka', 'Initials': 'M', 'LastName': 'Post', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Wes', 'Initials': 'W', 'LastName': 'Onland', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Department of Neonatology, University of Amsterdam, Amsterdam, the Netherlands.""}, {'ForeName': 'Aleid', 'Initials': 'A', 'LastName': 'van Wassenaer-Leemhuis', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Department of Neonatology, University of Amsterdam, Amsterdam, the Netherlands.""}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Naaktgeboren', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Janus C', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Titia', 'Initials': 'T', 'LastName': 'Lely', 'Affiliation': ""Wilhelmina Children's Hospital, Department of Obstetrics, University Medical Center Utrecht, Gynecology and Neonatology, Utrecht, the Netherlands.""}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Gordijn', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Wessel', 'Initials': 'W', 'LastName': 'Ganzevoort', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.5323'] 2870,32585039,Ibuprofen in needle procedures in children with cancer - a feasibility and pilot study.,"AIM To investigate the feasibility, and perform a pilot study, of a randomized clinical trial, investigating whether children experience less pain, fear and/or distress when they receive oral ibuprofen vs. placebo before a needle is inserted in a subcutaneously implanted intravenous port. METHODS 23 children were included consecutively and randomized to either oral ibuprofen (n = 12) 7.5 mg/kg body weight or placebo (n =11). The child's pain, fear and distress were reported by parents, nurses and the children (if ≥ 7 years of age). Feasibility criteria were defined as; 1) ≥4 children included/month, 2) ≥ 80% of eligible patients agreed to participate, 3) > 90% treated according to protocol, 4) <5 % missing data, 5) s-cortisol samples analyzed in ≥90% of the children. RESULTS All feasibility criteria were met except recruitment and consent. Parents, nurses and children reported no trend of benefit of oral ibuprofen with regard to pain, fear and distress compared with placebo. CONCLUSION The study failed to meet important feasibility criteria and was closed due to low recruitment rate and absence of trend of effect. From this data we cannot state that ibuprofen is not helpful in needle procedures but that it seems unlikely.",2020,"Parents, nurses and children reported no trend of benefit of oral ibuprofen with regard to pain, fear and distress compared with placebo. ","['23 children', 'children with cancer ', 'children experience less pain, fear', 'Feasibility criteria were defined as; 1) ≥4 children included/month, 2) ≥ 80% of eligible patients agreed to participate, 3) ']","['oral ibuprofen vs. placebo', 'Ibuprofen', 'ibuprofen', 'oral ibuprofen', 'placebo']","[""child's pain, fear and distress"", 'pain, fear and distress']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",23.0,0.0579768,"Parents, nurses and children reported no trend of benefit of oral ibuprofen with regard to pain, fear and distress compared with placebo. ","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kamsvåg', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hedén', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'von Essesn', 'Affiliation': ""Department of Women's and Children's Health, Clinical Psychology in Healthcare, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ljungman', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15449'] 2871,32483634,Pretreatment Assessment of Psychosocial Readiness Is Not Associated with Improved Treatment Outcomes in a Safety-Net HCV Treatment Clinic.,"OBJECTIVES Hepatitis C virus (HCV) is highly curable with antiviral therapy, and traditionally, treatment adherence has been critical for treatment success. We sought to determine whether assessing HCV treatment readiness with a structured treatment readiness tool was associated with increased rates of adherence and cure among patients at a safety-net HCV clinic. METHODS We administered the Psychosocial Readiness Evaluation and Preparation for HCV Treatment (PREP-C) tool to 50 patients and compared them with 50 patients who received the usual care. The outcome measures included achievement of treatment milestones (eg, adherence to treatment, clinic visit attendance) and sustained virologic response (cure). RESULTS We found no association between receiving the PREP-C assessment and outcomes, including referral to or starting HCV treatment, adherence to treatment, and HCV cure. CONCLUSIONS We found that receiving the PREP-C assessment did not improve treatment outcomes, suggesting that targeted pretreatment assessment is unnecessary even in a medically and psychosocially complex population.",2020,"We found no association between receiving the PREP-C assessment and outcomes, including referral to or starting HCV treatment, adherence to treatment, and HCV cure. ","['50 patients and compared them with 50 patients who received the usual care', 'patients at a safety-net HCV clinic']",['Psychosocial Readiness Evaluation and Preparation for HCV Treatment (PREP-C'],"['referral to or starting HCV treatment, adherence to treatment, and HCV cure', 'rates of adherence and cure', 'achievement of treatment milestones (eg, adherence to treatment, clinic visit attendance) and sustained virologic response (cure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]","[{'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",50.0,0.0291723,"We found no association between receiving the PREP-C assessment and outcomes, including referral to or starting HCV treatment, adherence to treatment, and HCV cure. ","[{'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Kopp', 'Affiliation': 'From the Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, and the Department of Medicine, Division of General Medicine and Geriatrics, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'From the Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, and the Department of Medicine, Division of General Medicine and Geriatrics, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Turbow', 'Affiliation': 'From the Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, and the Department of Medicine, Division of General Medicine and Geriatrics, Emory University School of Medicine, Atlanta, Georgia.'}]",Southern medical journal,['10.14423/SMJ.0000000000001099'] 2872,30124597,Long-Term Effects of Experimental Human Endotoxemia on Immune Cell Function: Similarities and Differences With Sepsis.,"Sepsis is the cause of more than 5.3 million deaths per year, and novel immunotherapeutic strategies are highly warranted. Human models that mirror sepsis immunology are instrumental to this aim. The response to endotoxin in humans during the first 24 h captures many hallmarks of the inflammatory response observed in sepsis. However, the long-term immunologic effects of human experimental endotoxemia have been sparsely studied and could be determinant for the use of this model in sepsis therapy research. In the present work, we studied the immune-composition of healthy subjects challenged with endotoxin (1 ng/kg) 4 h, 2 days, and 20 days post administration by flow cytometry to study the effects on innate and adaptive immune system, and compared it with the immune-composition in patients during the first 9 days after onset of septic shock. We found several differences and similarities between these groups. Experimental endotoxemia resulted in an increase in absolute numbers of intermediate monocytes, which also displayed lower human leucocyte antigen expression 20 days post endotoxin. These changes differed with those observed in septic shock patients. Another long-term effect of experimental endotoxemia was elevated numbers of effector CD8 cells and an increased percentage of proliferating and cytokine expressing CD8 cells, and these phenomena were also present in sepsis patients. In conclusion, despite considerable differences, experimental endotoxemia captures several long-term aspects of sepsis immunology, specifically the behavior of CD8 T cells, which may eventually aid the development of new therapies for sepsis patients.",2019,"Experimental endotoxemia resulted in an increase in absolute numbers of intermediate monocytes, which also displayed lower human leucocyte antigen expression 20 days post endotoxin.","['healthy subjects challenged with', 'sepsis patients']","['endotoxin', 'Experimental Human Endotoxemia']","['Immune Cell Function', 'percentage of proliferating and cytokine expressing CD8 cells', 'effector CD8 cells', 'absolute numbers of intermediate monocytes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0376618', 'cui_str': 'Endotoxemia'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}]",,0.0770114,"Experimental endotoxemia resulted in an increase in absolute numbers of intermediate monocytes, which also displayed lower human leucocyte antigen expression 20 days post endotoxin.","[{'ForeName': 'Yessica Alina', 'Initials': 'YA', 'LastName': 'Rodriguez-Rosales', 'Affiliation': 'Department of Laboratory Medicine, Laboratory of Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Rijssen', 'Affiliation': 'Department of Laboratory Medicine, Laboratory of Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'van Cranenbroek', 'Affiliation': 'Department of Laboratory Medicine, Laboratory of Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'van Welie', 'Affiliation': 'Department of Laboratory Medicine, Laboratory of Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Joosten', 'Affiliation': 'Department of Laboratory Medicine, Laboratory of Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans J P M', 'Initials': 'HJPM', 'LastName': 'Koenen', 'Affiliation': 'Department of Laboratory Medicine, Laboratory of Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001222'] 2873,30797386,"Alcohol Behavioral Couple Therapy: In-session behavior, active ingredients and mechanisms of behavior change.","OBJECTIVE Alcohol Behavioral Couple Therapy (ABCT) is an efficacious alcohol treatment. The purpose of the study was to describe patient and partner language and therapist behavior during therapy sessions and test a proposed causal model linking active ingredients of ABCT as measured by therapist behaviors, hypothesized mechanisms of behavior change as measured by in-session patient and partner language, and alcohol use outcomes. METHOD Data came from couples in four ABCT clinical trials (N = 188; 86 males, 102 females, and their partners). Patient and partner verbal behaviors in session one and a mid-treatment session were coded using the System for Coding Couples' Interactions in Therapy-Alcohol. Therapist behavior was coded using the Couples Treatment Integrity Rating System. Percent days abstinent was calculated from daily drinking data for the first and second half of treatment and six months post-treatment. RESULTS Therapists delivered an adequate level of the ABCT interventions during treatment. During treatment, couples increased positive behaviors, talked less about drinking, and decreased their amount of motivational language. Therapist behaviors did not predict patient or partner behaviors during treatment or drinking outcomes. Partner advice in the first session predicted poorer drinking outcomes. At mid-treatment, patient behaviors as a block, and specific behaviors of contemptuousness toward their partner and sustain talk, predicted poorer drinking outcomes. CONCLUSIONS During ABCT, patients decrease their drinking, and patient and partner behaviors change in predicted ways. Partner advice, patient contemptuousness, and patient sustain talk predicted poorer outcomes. Analyses of within-session verbal behavior did not support the hypothesized mechanisms for change for ABCT.",2019,Therapist behaviors did not predict patient or partner behaviors during treatment or drinking outcomes.,"['Data came from couples in four ABCT clinical trials (N\u202f=\u202f188; 86 males, 102 females, and their partners']","['Alcohol Behavioral Couple Therapy', 'Alcohol Behavioral Couple Therapy (ABCT']","['partner behaviors', 'Patient and partner verbal behaviors', 'Therapist behaviors', 'Therapist behavior', 'drinking, and patient and partner behaviors change', 'positive behaviors, talked less about drinking, and decreased their amount of motivational language', 'poorer drinking outcomes']","[{'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0302822', 'cui_str': 'Couple Therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0302822', 'cui_str': 'Couple Therapy'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042530', 'cui_str': 'Verbal Behavior'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",188.0,0.021899,Therapist behaviors did not predict patient or partner behaviors during treatment or drinking outcomes.,"[{'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'McCrady', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America. Electronic address: bmccrady@unm.edu.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Tonigan', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America. Electronic address: jtonigan@unm.edu.'}, {'ForeName': 'Benjamin O', 'Initials': 'BO', 'LastName': 'Ladd', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America. Electronic address: Benjamin.ladd@wsu.edu.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America. Electronic address: khallgre@uw.edu.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Pearson', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America.'}, {'ForeName': 'Mandy D', 'Initials': 'MD', 'LastName': 'Owens', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America. Electronic address: mandyo@uw.edu.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Center of Alcohol Studies, Rutgers - The State University of New Jersey, 607 Allison Rd., Piscataway, NJ 08854, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.018'] 2874,30797397,The dissociative subtype of PTSD in women with substance use disorders: Exploring symptom and exposure profiles.,"The dissociative subtype of posttraumatic stress disorder (PTSD) was officially introduced in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). In accordance with this new classification, prior studies using Latent Class Analysis (LCA) empirically identified a subgroup of patients that were characterized by a high severity of dissociative symptoms. Despite the high prevalence of PTSD in patients with substance use disorders (SUD), however, no LCA studies on the dissociative subtype of PTSD exist in this population so far. Therefore, the current study aimed to identify subgroups of patients with different symptom and exposure profiles in patients with SUD and PTSD. It was assumed that one symptom and exposure profile could be identified that would be characterized by higher dissociative symptoms, higher additional psychopathology and a higher burden of childhood trauma, as compared to other subgroups. In N = 258 female patients with SUD and PTSD, clinical characteristics of dissociative symptoms, PTSD severity, borderline personality disorder (BPD), depression, childhood trauma and substance abuse were assessed. To identify symptom and exposure profiles, Latent Class Analysis was applied. A three-class solution indicated the best model fit to our data. One class was characterized by a high probability of dissociative symptoms (D-PTSD class), whereas the other two classes were characterized by lower probabilities of dissociative symptoms. The D-PTSD class encompassed 18.7% of the patients. In accordance with our hypothesis, the D-PTSD class showed higher probabilities of PTSD severity, borderline personality disorder symptoms, depressive symptoms, childhood emotional and sexual abuse, childhood emotional neglect, and drug abuse. Our results indicate that the dissociative subtype of PTSD could also be identified in a sample of female patients with SUD. Patients with SUD and PTSD characterized by the dissociative subtype showed more severe psychopathological symptoms than the remaining patients, indicating enhanced clinical needs for this vulnerable group.",2019,"Patients with SUD and PTSD characterized by the dissociative subtype showed more severe psychopathological symptoms than the remaining patients, indicating enhanced clinical needs for this vulnerable group.","['women with substance use disorders', 'patients with SUD and PTSD', 'female patients with SUD', 'In N\u202f=\u202f258 female patients with SUD and PTSD, clinical characteristics of dissociative symptoms, PTSD severity, borderline personality disorder (BPD), depression, childhood trauma and substance abuse were assessed', 'patients with substance use disorders (SUD']",[],"['severe psychopathological symptoms', 'probabilities of PTSD severity, borderline personality disorder symptoms, depressive symptoms, childhood emotional and sexual abuse, childhood emotional neglect, and drug abuse']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse'}]",258.0,0.0120754,"Patients with SUD and PTSD characterized by the dissociative subtype showed more severe psychopathological symptoms than the remaining patients, indicating enhanced clinical needs for this vulnerable group.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Gidzgier', 'Affiliation': 'Center for Interdisciplinary Addiction Research, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: p.gidzgier@uke.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Grundmann', 'Affiliation': 'Center for Interdisciplinary Addiction Research, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: j.grundmann@uke.de.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Lotzin', 'Affiliation': 'Center for Interdisciplinary Addiction Research, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: a.lotzin@uke.de.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hiller', 'Affiliation': 'Center for Interdisciplinary Addiction Research, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: hiller@zis-hamburg.de.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schneider', 'Affiliation': 'Department of Addictive Disorders and Psychiatry, LVR-Klinik Cologne, Wilhelm-Griesinger-Strasse 23, 51109 Cologne, Germany. Electronic address: b.schneider@lvr.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Driessen', 'Affiliation': 'Department of Psychiatry and Psychotherapy Bethel, Ev. Krankenhaus Bielefeld, Burgsteig 13, 33617 Bielefeld, Germany. Electronic address: martin.driessen@evkb.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Department of Psychiatry, Psychotherapy, Psychosomatic and Addiction Medicine, Kliniken Essen-Mitte, Henricistrasse 92, 45136 Essen, Germany. Electronic address: m.schaefer@kliniken-essen-mitte.de.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Scherbaum', 'Affiliation': 'LVR-Hospital Essen, Department of Addictive Behaviour and Addiction Medicine, Medical Faculty, University of Duisburg-Essen, Virchowstrasse 174, 45147 Essen, Germany. Electronic address: norbert.scherbaum@uni-due.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hillemacher', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Carl-Neuberg-Straße 1D, 30625 Hannover, Germany; Department of Psychiatry and Psychotherapy, Paracelsus Medical University Nuremberg, Prof.-Ernst-Nathan-Str. 1, 90419 Nuremberg, Germany. Electronic address: thomas.hillemacher@klinikum-nuernberg.de.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schäfer', 'Affiliation': 'Center for Interdisciplinary Addiction Research, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: i.schaefer@uke.de.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.004'] 2875,32589302,Effects of chewing exercises on the occlusal force and masseter muscle thickness in community-dwelling Koreans aged 65 years and older: A randomized assessor-blind trial.,"BACKGROUND Chewing exercises have been applied in clinical settings to improve the occlusal force and function of the masseter muscle in elderly individuals. However, the clinical relevance and effects of chewing exercises are unclear. OBJECTIVES This study aimed to investigate the effects of bilateral chewing exercises on the occlusal force and masseter muscle thickness in community-dwelling Koreans aged 65 years. METHODS Forty community-dwelling healthy elderly individuals were enrolled in this study. They were assigned to the experimental or the control group. The experimental group performed chewing exercises using medical equipment developed to facilitate such exercises. The chewing exercises were divided into isometric and isotonic types and were performed for 20 min/d, 5 days/wk, for 6 weeks. The control group did not perform any chewing exercises. The outcome measures were occlusal force and masseter muscle thickness, which were evaluated using an occlusometer and ultrasound device, respectively. A paired t-test and an independent t-test was used to evaluate the training effects. RESULTS Within-group comparisons showed that occlusal force and masseter muscle thickness improved significantly in the experimental group (p < 0.001 for both), while the control group showed no significant improvements (p = 0.098 and 0.130). Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (p < 0.05 for both) compared to the control group. CONCLUSION These results suggest that chewing exercises are effective in improving occlusal force and masseter muscle thickness in healthy elderly individuals.",2020,"Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (p < 0.05 for both) compared to the control group. ","['elderly individuals', 'community-dwelling Koreans aged 65 years and older', 'community-dwelling Koreans aged 65 years', 'Forty community-dwelling healthy elderly individuals', 'healthy elderly individuals']","['chewing exercises using medical equipment developed to facilitate such exercises', 'chewing exercises', 'bilateral chewing exercises', 'control group did not perform any chewing exercises']",['occlusal force and masseter muscle thickness'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0589278', 'cui_str': 'Chewing exercises'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0261273,"Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (p < 0.05 for both) compared to the control group. ","[{'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Hygiene, DongSeo University, Busan, Republic of Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Multidisplinary Radiological Science, DongSeo University, Busan, Republic of Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Occupational Therapy, Division of Health Sciences, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Se-Hyun', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Dental Hygiene, DongJu College, Busan, Republic of Korea.'}, {'ForeName': 'Hwan-Hee', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon, Republic of Korea.'}, {'ForeName': 'YoungJin', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Department of Multidisplinary Radiological Science, DongSeo University, Busan, Republic of Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, Republic of Korea.'}]",Journal of oral rehabilitation,['10.1111/joor.13036'] 2876,32589312,Keeping Our Staff In Mind: dietary results of a lifestyle intervention targeting mental health staff.,"ISSUES ADDRESSED 1) describe the dietary intake of mental health staff within XXX , and 2) evaluate the impact of an individualised staff lifestyle program on the following nutrition parameters; (i) energy, (ii) core food groups, and (iii) discretionary foods. METHODS This was a pragmatic single-arm intervention study, conducted for all staff working in a public mental health service, in Sydney, Australia. A five-session individualised lifestyle intervention delivered over 5 weeks incorporated nutritional counselling delivered by a dietitian. Participants were assessed at baseline, following the intervention, and at follow-up using diet history to assess dietary intake. RESULTS 88 staff completed the dietary intervention and follow-up. An intake of core food groups significantly below national recommendations were reported for total vegetables (-1.75±0.14 serves, p < 0.001), fruit (-0.29±0.11 serves, p = 0.01), grains (-1.25±0.20 serves, p < 0.001) and dairy servings (-1.00±1.08 serves, p < 0.001), and protein-based foods were significantly above national recommendations (0.2±0.09 serves, p = 0.03). At completion of the program, energy from discretionary foods was reduced by 460kJ (95% CI -635 to -285, p < 0.001), and the serves of total vegetables (0.91 serves, 95% CI 0.59 to 1.22, p < 0.001) and dairy (0.31 serves, 95% CI 0.11 to 0.50, p < 0.001) were increased significantly. CONCLUSIONS A workplace based wellbeing program for staff working in the mental health setting coincided with dietary improvements SO WHAT: Mental health staff can act as positive role models for clients to promote developing positive physical health behaviors.",2020,"At completion of the program, energy from discretionary foods was reduced by 460kJ (95% CI -635 to -285, p < 0.001), and the serves of total vegetables (0.91 serves, 95% CI 0.59 to 1.22, p < 0.001) and dairy (0.31 serves, 95% CI 0.11 to 0.50, p < 0.001) were increased significantly. ","['all staff working in a public mental health service, in Sydney, Australia']",[],"['dairy servings', 'total vegetables', 'serves of total vegetables']","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",,0.0627464,"At completion of the program, energy from discretionary foods was reduced by 460kJ (95% CI -635 to -285, p < 0.001), and the serves of total vegetables (0.91 serves, 95% CI 0.59 to 1.22, p < 0.001) and dairy (0.31 serves, 95% CI 0.11 to 0.50, p < 0.001) were increased significantly. ","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rossimel', 'Affiliation': 'Keeping the Body in Mind Program, South Eastern Sydney Local Health District, Australia, Sydney.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Teasdale', 'Affiliation': 'Keeping the Body in Mind Program, South Eastern Sydney Local Health District, Australia, Sydney.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Poole', 'Affiliation': 'Keeping the Body in Mind Program, South Eastern Sydney Local Health District, Australia, Sydney.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Fibbins', 'Affiliation': 'Keeping the Body in Mind Program, South Eastern Sydney Local Health District, Australia, Sydney.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Keeping the Body in Mind Program, South Eastern Sydney Local Health District, Australia, Sydney.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Keeping the Body in Mind Program, South Eastern Sydney Local Health District, Australia, Sydney.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'School of Psychiatry, University of New South Wales, Australia, Sydney.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Ward', 'Affiliation': 'School of Psychiatry, University of New South Wales, Australia, Sydney.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.377'] 2877,32583431,"Randomised phase II study to optimise melphalan, prednisolone, and bortezomib in untreated multiple myeloma (JCOG1105).","We conducted a randomised phase II study to determine the optimal dose and schedule of melphalan, prednisone, and bortezomib (MPB) (jRCTs031180097). Transplant-ineligible untreated multiple myeloma patients were randomised to Arm A (twice weekly bortezomib in one six-week cycle followed by eight five-week cycles of four times once weekly bortezomib with melphalan and prednisolone on days 1-4) or Arm B (nine four-week cycles of three times once weekly bortezomib with melphalan and prednisolone on days 1-4). The primary end-point was complete response (CR) rate. Of 91 patients randomised to two arms, 88 were eligible. The median cumulative bortezomib doses were 45·8 and 35·1 mg/m 2 , CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR) 1·93 (95% CI 1·09-3·42)], respectively. Frequent grade ≥3 haematologic toxicities in Arms A and B were neutropenia (64·4% vs. 28·3%) and thrombocytopenia (35·6% vs. 10·9%). Grade 2/3 peripheral neuropathy was observed in 24·4/2·2% in Arm A and 8·7/0% in Arm B. In conclusion, Arm A was the more promising regimen, suggesting that the twice weekly schedule of bortezomib in the first cycle and higher cumulative dose of both bortezomib and melphalan influences the efficacy of modified MPB.",2020,", CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR)","['1·93', 'Transplant-ineligible untreated multiple myeloma patients', '91 patients randomised to two arms, 88 were eligible']","['bortezomib and melphalan', 'melphalan, prednisone, and bortezomib (MPB', 'bortezomib with melphalan and prednisolone', 'optimise melphalan, prednisolone, and bortezomib', 'bortezomib']","['neutropenia', 'complete response (CR) rate', 'CR rate', 'Frequent grade ≥3 haematologic toxicities', 'thrombocytopenia', 'Grade 2/3 peripheral neuropathy', 'median progression-free survival (PFS', 'median cumulative bortezomib doses']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0926135,", CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR)","[{'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'JCOG Data Center/Operating Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Hematology and Oncology, Mie University School of Medicine, Tsu, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yoshimitsu', 'Affiliation': 'Department of Hematology and Rheumatology, Kagoshima University Hospital, Kagoshima, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuroda', 'Affiliation': 'Division of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Norifumi', 'Initials': 'N', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Hematology, Gunma University, Maebashi, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tsujimura', 'Affiliation': 'Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Hangaishi', 'Affiliation': 'Division of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Hematology and Oncology, University of Fukui Hospital, Fukui, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Utsumi', 'Affiliation': 'Department of Hematology, Shiga General Hospital, Moriyama, Japan.'}, {'ForeName': 'Ishikazu', 'Initials': 'I', 'LastName': 'Mizuno', 'Affiliation': 'Division of Hematology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Nagata', 'Affiliation': 'Department of Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Minauchi', 'Affiliation': 'Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Ohtsuka', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Oita, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Hanamura', 'Affiliation': 'Division of Hematology, Aichi Medical University, Nagakute, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.'}, {'ForeName': 'Youko', 'Initials': 'Y', 'LastName': 'Suehiro', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Clinical Oncology and Hematology, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Department of Hematology, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}]",British journal of haematology,['10.1111/bjh.16878'] 2878,32583478,Comparing integrative cognitive-affective therapy and guided self-help cognitive-behavioral therapy to treat binge-eating disorder using standard and naturalistic momentary outcome measures: A randomized controlled trial.,"OBJECTIVE Innovative treatments and outcome measures are needed for binge-eating disorder (BED). This randomized controlled trial compared Integrative Cognitive-Affective Therapy (ICAT-BED), an individual psychotherapy targeting momentary behavioral and emotional precipitants of binge eating, with an established cognitive-behavioral guided self-help (CBTgsh) treatment using standard and ecological momentary assessment (EMA) outcome measures. METHOD A total of 112 participants were randomized to 17 weeks of treatment (21 sessions for ICAT-BED and 10 sessions for CBTgsh). Binge-eating frequency was assessed with the Eating Disorder Examination (EDE) as well as EMA using cell phone-based real-time, naturalistic assessment at end of treatment (EOT) and 6-month follow-up. Hypothesized maintenance mechanisms were assessed using self-report questionnaires. RESULTS Binge-eating frequency as measured by the EDE and real-time assessment showed significant reductions at EOT and follow-up, with no significant differences between treatments. Hypothesized maintenance mechanisms, including emotion regulation, cognitive self-discrepancy, self-directed style, as well as measures of associated eating disorder psychopathology, depression, anxiety, impulsivity, and negative affect, showed similar improvement at EOT and follow-up with no differences between treatments. Abstinence rates at EOT (ICAT-BED: 57.1%; CBTgsh: 42.9%) and 6-month follow-up (ICAT-BED: 46.4%; CBTgsh: 42.9%) were not significantly different. Treatment retention was significantly higher for ICAT-BED (87.5%) than CBTgsh (71.4%). DISCUSSION These findings suggest that ICAT-BED and CBTgsh were associated with similar improvements in binge eating, psychopathology, and putative maintenance mechanisms as measured by traditional self-report and momentary, naturalistic assessments and that these changes were generally sustained at 6-month follow-up.",2020,"RESULTS Binge-eating frequency as measured by the EDE and real-time assessment showed significant reductions at EOT and follow-up, with no significant differences between treatments.",['A total of 112 participants'],"['Integrative Cognitive-Affective Therapy (ICAT-BED', 'established cognitive-behavioral guided self-help (CBTgsh) treatment using standard and ecological momentary assessment (EMA', 'integrative cognitive-affective therapy and guided self-help cognitive-behavioral therapy']","['Abstinence rates', 'ICAT-BED', 'binge eating, psychopathology, and putative maintenance mechanisms', 'Binge-eating frequency', 'Treatment retention', 'emotion regulation, cognitive self-discrepancy, self-directed style', 'eating disorder psychopathology, depression, anxiety, impulsivity', 'Eating Disorder Examination (EDE']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}]",112.0,0.04859,"RESULTS Binge-eating frequency as measured by the EDE and real-time assessment showed significant reductions at EOT and follow-up, with no significant differences between treatments.","[{'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Strauman', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Smith', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Mitchell', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Erickson', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Bjorlie', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}]",The International journal of eating disorders,['10.1002/eat.23324'] 2879,32583501,Effectiveness of an attachment-based intervention for the assessment of parenting capacities in maltreating families: A randomized controlled trial.,"Even though Parenting Capacity Assessments (PCAs) are essential for child protection services to support placement decisions for maltreating families, presently no evidence-based PCA protocols are available. In this randomized controlled trial, we tested the quality of an attachment-based PCA protocol based on Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD). We recruited 56 parent-child dyads (M age children = 3.48 years) in Dutch family residential clinics that conduct PCAs to support placement decisions. After pretest, families were randomized to receive the Regular Assessment Procedure (RAP) (n = 28), or an additional assessment based on VIPP-SD (n = 28). An immediate post-test and a 10-month follow-up were conducted. Multilevel models showed that therapists felt equally confident about their recommendations regarding child placement for both groups and that they equally often modified their initial placement recommendations. Moreover, children in the VIPP-SD group did not show fewer behavior problems and did not experience recurring child maltreatment less often than children in the RAP group. Thus, we found no evidence that PCAs incorporating the VIPP-SD protocol outperformed PCAs as usual. We discuss possible explanations why in the current study VIPP-SD did not seem to add to the quality of the RAP.",2020,Multilevel models showed that therapists felt equally confident about their recommendations regarding child placement for both groups and that they equally often modified their initial placement recommendations.,"['maltreating families', '56 parent-child dyads (M age children = 3.48 years) in Dutch family residential clinics that conduct PCAs to support placement decisions']","['attachment-based intervention', 'Regular Assessment Procedure (RAP', 'attachment-based PCA protocol based on Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD']",['behavior problems'],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.107994,Multilevel models showed that therapists felt equally confident about their recommendations regarding child placement for both groups and that they equally often modified their initial placement recommendations.,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'van der Asdonk', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Whitney D', 'Initials': 'WD', 'LastName': 'de Haan', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Sheila R', 'Initials': 'SR', 'LastName': 'van Berkel', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Marinus H', 'Initials': 'MH', 'LastName': 'van IJzendoorn', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ralph C A', 'Initials': 'RCA', 'LastName': 'Rippe', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Schuengel', 'Affiliation': 'Clinical Child and Family Studies, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Kuiper', 'Affiliation': 'Youth Expert Center, University of Applied Sciences, Leiden, The Netherlands.'}, {'ForeName': 'Ramon J L', 'Initials': 'RJL', 'LastName': 'Lindauer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Overbeek', 'Affiliation': 'Clinical Child and Family Studies, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lenneke R A', 'Initials': 'LRA', 'LastName': 'Alink', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands.'}]",Infant mental health journal,['10.1002/imhj.21874'] 2880,32583557,Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141).,"BACKGROUND The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial. METHODS The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed. RESULTS The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs. CONCLUSIONS Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. CLINICAL TRIAL REGISTRATION NCT02105636.",2020,"The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively.","['patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN', ""34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed"", 'Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141']",['nivolumab'],"['adverse events (TRAEs), including skin-related disorders', '2-year survival', 'prolonged OS benefits', 'median overall survival (OS', '2-year OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",34.0,0.0661625,"The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively.","[{'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Hanai', 'Affiliation': 'Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Yokota', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shigemichi', 'Initials': 'S', 'LastName': 'Iwae', 'Affiliation': 'Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Medical Oncology, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Ruey-Long', 'Initials': 'RL', 'LastName': 'Hong', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Jin-Hyoung', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Wing Sum Kenneth', 'Initials': 'WSK', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, China.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, University of Pittsburgh Medical Center Cancer Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Gillison', 'Affiliation': 'Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Section 1, Oncology Medical Affairs, ONO Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Vijayvel', 'Initials': 'V', 'LastName': 'Jayaprakash', 'Affiliation': 'Oncology Clinical Development, BMS, Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}]",Head & neck,['10.1002/hed.26331'] 2881,32583727,Effects of an aerobic fitness test on short- and long-term memory in elementary-aged children.,"Meta-analytic evidence supports that exercise has benefits for short-term memory (STM) and long-term memory (LTM). However, only three studies with children have tested the differential effects of exercise on STM and LTM. The purpose of this study was to examine the effects of an aerobic fitness test on STM and LTM and to consider the moderating effects of grade level. Children (7-13 years of age) were randomly assigned to either perform an aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT) to assess memory. Memory was tested again after approximately 24 hours. There were significant differences in memory performance as a function of grade with 4 th and 6 th graders consistently outperforming 2 nd graders. For learning, Day 1 Retention, 24-hr recall, and Day 2 Retention, the exercise prior group performed better than the exercise post group. It is concluded that an aerobic fitness test performed prior to a declarative memory test benefits LTM as compared to when the aerobic fitness test is performed after the memory test.",2020,There were significant differences in memory performance as a function of grade with 4 th and 6 th graders consistently outperforming 2 nd graders.,"['Children (7-13\xa0years of age', 'elementary-aged children']","['aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT', 'aerobic fitness test']","['short- and long-term memory', 'memory performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0423909', 'cui_str': 'Long-term memory performance'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",,0.031325,There were significant differences in memory performance as a function of grade with 4 th and 6 th graders consistently outperforming 2 nd graders.,"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sprick', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Chia-Hao', 'Initials': 'CH', 'LastName': 'Shih', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Glass', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jarod C', 'Initials': 'JC', 'LastName': 'Vance', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}]",Journal of sports sciences,['10.1080/02640414.2020.1778251'] 2882,32583773,Bio-therapeutics effects of probiotic strain on the gastrointestinal health of severely acute malnourished children.,"The core objective was to evaluate the effect of probiotic fortification at three phases of formula milk administration in malnourished children. A dose related effect was determined in 30 severely acute malnourished children (6-59 months) in a double-blind, randomized design. According to the results, serum albumin levels, treatment T2 (6 billion cfu) has significantly increased albumin levels (3.7g/dL) and the effect of phase-III (Plumpy'nut) was found to be better. Results regarding sodium levels showing probiotic-dose have significant effect (P≤0.05) in phases as well. Moreover, the effect of T1 i.e. 3 billion cfu of probiotics has significantly reduced sodium levels (141.8mmol/L) vs. others and the effect of phase-II was better on reducing sodium levels. which is further confirmed in terms of reduced erythrocyte sedimentation rate levels at phase-III (29.566 vs. phase-II, 41.3 and phase-I, 46.533 mm/h). Conclusively, the effect of 6 billion cfu at phase-III was more effective on blood parameters.",2020,Results regarding sodium levels showing probiotic-dose have significant effect (P≤0.05) in phases as well.,"['malnourished children', '30 severely acute malnourished children (6-59 months', 'severely acute malnourished children']","['probiotic strain', 'probiotic fortification']","['erythrocyte sedimentation rate levels', 'blood parameters', 'serum albumin levels', 'albumin levels', 'sodium levels']","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement'}]",30.0,0.0380348,Results regarding sodium levels showing probiotic-dose have significant effect (P≤0.05) in phases as well.,"[{'ForeName': 'Habib-Ur-', 'Initials': 'HU', 'LastName': 'Rehman', 'Affiliation': 'Department of Food Science & Human Nutrition, University of Veterinary & Animal Sciences, Lahore, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Nasir', 'Affiliation': 'Department of Food Science & Human Nutrition, University of Veterinary & Animal Sciences, Lahore, Pakistan.'}, {'ForeName': 'Makhdoom', 'Initials': 'M', 'LastName': 'Abdul Jabbar', 'Affiliation': 'Department of Food Science & Human Nutrition, University of Veterinary & Animal Sciences, Lahore, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ayaz', 'Affiliation': 'Department of Dairy Technology, University of Veterinary & Animal Sciences, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Asif', 'Initials': 'MA', 'LastName': 'Ali', 'Affiliation': 'Department of Food Science & Human Nutrition, University of Veterinary & Animal Sciences, Lahore, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Imran', 'Affiliation': 'University Institute of Diet and Nutritional Sciences, Faculty of Allied Health Sciences, The University of Lahore-Lahore, Pakistan.'}, {'ForeName': 'Tanweer Aslam', 'Initials': 'TA', 'LastName': 'Gondal', 'Affiliation': 'School of Exercise and Nutrition, Faculty of Health, Deakin University, Victoria 3125, Australia.'}, {'ForeName': 'Tabussam', 'Initials': 'T', 'LastName': 'Tufail', 'Affiliation': 'University Institute of Diet and Nutritional Sciences, Faculty of Allied Health Sciences, The University of Lahore-Lahore, Pakistan.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Aslam', 'Affiliation': 'Department of Food Science & Human Nutrition, University of Veterinary & Animal Sciences, Lahore, Pakistan.'}, {'ForeName': 'Tahira Batool', 'Initials': 'TB', 'LastName': 'Qaisrani', 'Affiliation': 'Department of Agricultural Engineering and Technology, Ghazi University, Dera Ghazi Khan.'}, {'ForeName': 'Muhammad Umair', 'Initials': 'MU', 'LastName': 'Sattar', 'Affiliation': 'Punjab Food Authority, Lahore, Pakistan.'}, {'ForeName': 'Bahare', 'Initials': 'B', 'LastName': 'Salehi', 'Affiliation': 'Student Research Committee, School of Medicine, Bam University of Medical Sciences, Bam, Iran.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Martins', 'Affiliation': 'Faculty of Medicine, University of Porto, Alameda Professor Hernâni Monteiro, 4200-319 Porto, Portugal.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Sharifi-Rad', 'Affiliation': 'Phytochemistry Research Center, Shahid Beheshti University of Medical Sciences, Tehran 1991953381, Iran.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[] 2883,32583907,Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation.,"BACKGROUND Agonists of 5-hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS-C). However, only tegaserod has been approved for a very limited population in the US. AIM To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS-C. METHODS A double-blind, placebo-controlled, dose-finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The primary endpoint was Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements from baseline and improvement of ≥30% from baseline in weekly average of worst abdominal pain score, both in the same week for ≥6/12 weeks). RESULTS The FDA composite responder rate was 13.6% (14/103) in the placebo group, 13.6% (14/103) in the 10 mg group, 19.2% (20/104) in the 20 mg group and 14.9% (15/101) in the 40 mg group, and no dose-response relationship was found. A greater percentage of minesapride 40 mg-treated patients than placebo-treated patients met both responder requirements for ≥9/12 weeks as the stricter composite evaluation (P < 0.05). Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12). The most common adverse event was mild diarrhoea. CONCLUSIONS Minesapride was safe and well-tolerated. Although the primary endpoint was negative, minesapride 40 mg is likely to improve the stricter composite endpoint and SBM frequency. Japan Pharmaceutical Information Center Number: Japic CTI-163459.",2020,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","['irritable bowel syndrome with predominant constipation (IBS-C', 'patients with Rome IV defined IBS-C', 'irritable bowel syndrome with predominant constipation', '411 patients']","['5-hydroxytryptamine', 'minesapride vs placebo', 'minesapride', 'placebo']","['stricter composite endpoint and SBM frequency', 'SBM frequency', 'Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements', 'efficacy and safety', 'safe and well-tolerated', 'worst abdominal pain score', 'FDA composite responder rate']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",411.0,0.467554,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","[{'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Inada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kiyoyasu', 'Initials': 'K', 'LastName': 'Kazumori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15907'] 2884,32454218,Safety of leadless pacemaker implantation in the very elderly.,"BACKGROUND The Micra leadless pacemaker (MLP) has proven to be an effective alternative to a traditional transvenous pacemaker (TVP). However, there has been concern about using the MLP in frail elderly patients because of the size of the implant sheath and perceived risk of perforation. OBJECTIVES The objectives of this study were to report the safety of the MLP and compare MPLs with TVPs in the very elderly. METHODS All patients 85 years and older who received an MLP or a single-chamber TVP across 6 hospitals in the Northwell Health system from December 2015 to November 2019 were included. Demographic characteristics, procedural details, and procedure-related complications were reviewed. RESULTS Over 4 years, 564 patients underwent MLP implantation. During this time, 183 MLPs and 119 TVPs were implanted in patients 85 years and older. The mean age was 89.7 ± 3.4 years, and 47.4% were men. MLP implantation was successful in all but 3 patients (98.4% success rate). There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276). Complications included 5 access site hematomas in the MLP group, 3 in the TVP group, 1 pericardial effusion in each group, and 3 acute lead dislodgments (<24 hours) in the TVP group. MLP implantation resulted in a significantly shorter mean procedure time (35.7 ± 23.0 minutes vs 62.3 ± 31.5 minutes, P < .001). CONCLUSION In a large multicenter study of patients 85 years and older, MLP implantation (1) was successful in 98.4% of patients, (2) was safe with no difference in procedure-related complications compared to the TVP group, and (3) resulted in significantly shorter procedure times.",2020,There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276).,"['patients 85 years and older, MLP implantation (1', 'across 6 hospitals in the Northwell Health system from December 2015 to November 2019 were included', 'All patients 85 years and older who received an', 'frail elderly patients', 'The mean age was 89.7 ± 3.4 years, and 47.4% were men', '564 patients underwent MLP implantation', 'patients 85 years and older']","['leadless pacemaker implantation', 'MLP implantation', 'MLP', 'MLP or a single-chamber TVP']","['mean procedure time', 'procedure-related complications', 'shorter procedure times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0336574', 'cui_str': 'Cardiac transvenous pacemaker'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.0862507,There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276).,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pagan', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York. Electronic address: eapagan13@gmail.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gabriels', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Khodak', 'Affiliation': 'Department of Medicine, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chang', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Beldner', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Laurence M', 'Initials': 'LM', 'LastName': 'Epstein', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Willner', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}]",Heart rhythm,['10.1016/j.hrthm.2020.05.022'] 2885,32580282,The Effects of a Low Calorie Ketogenic Diet on Glycaemic Control Variables in Hyperinsulinemic Overweight/Obese Females.,"Diet is a factor which can influence both glycaemic variables and body mass. The aim of this study was to compare the influence of a 12-week, well-planned, low-calorie ketogenic diet (LCKD) on hyperglycaemic, hyperinsulinemic and lipid profile in adult, overweight or obese females. Ninety-one females who participated in the study were divided into two groups: a LCKD group who followed a hypocaloric ketogenic diet (8% of carbohydrate, 72% of fat and 20% of proteins) ( n = 46), and a control group (CG) ( n = 45) who continued their typical diet (50% of carbohydrates, 32% of fat and 18% of proteins). METHODS Baseline and post-intervention glucose (Gl), insulin (I), glycated haemoglobin (HbA1c), Homeostatic model assessment HOMA-IR, triglycerides (TG) and high-density cholesterol (HDL-C) were evaluated. Also, body mass (BM), waist circumference (WC), hip circumference (HC) and thigh circumference (TC) were measured. RESULTS Compared with the CG, there were significant changes observed in the LCKD group regarding all biochemical variables. Also, BM, TC, WC and AC changed significantly in the LCKD group compared with the CG. CONCLUSIONS The 12-week LCKD intervention changed the glucose control variables, body mass, as well as waist, hip and thigh circumferences. A low-calorie ketogenic diet may be recommended for adult females with glucose control variables disturbance and excess body mass.",2020,"Compared with the CG, there were significant changes observed in the LCKD group regarding all biochemical variables.","['Ninety-one females who participated in the study', 'adult, overweight or obese females', 'Hyperinsulinemic Overweight/Obese Females', 'adult females with glucose control variables disturbance and excess body mass']","['well-planned, low-calorie ketogenic diet (LCKD', 'control group (CG) ( n = 45) who continued their typical diet', 'LCKD group who followed a hypocaloric ketogenic diet', 'LCKD', 'Low Calorie Ketogenic Diet']","['hyperglycaemic, hyperinsulinemic and lipid profile', 'body mass (BM), waist circumference (WC), hip circumference (HC) and thigh circumference (TC', 'post-intervention glucose (Gl), insulin (I), glycated haemoglobin (HbA1c), Homeostatic model assessment HOMA-IR, triglycerides (TG) and high-density cholesterol (HDL-C', 'BM, TC, WC and AC', 'Glycaemic Control Variables']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",91.0,0.0169054,"Compared with the CG, there were significant changes observed in the LCKD group regarding all biochemical variables.","[{'ForeName': 'Małgorzata Magdalena', 'Initials': 'MM', 'LastName': 'Michalczyk', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, 72a Mikołowska Street, 40-065 Katowice, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Klonek', 'Affiliation': 'Lenacor Diet Clinic, Świętojańska 2a Street, 41-400 Mysłowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Maszczyk', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, 72a Mikołowska Street, 40-065 Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, 72a Mikołowska Street, 40-065 Katowice, Poland.'}]",Nutrients,['10.3390/nu12061854'] 2886,32580698,Explaining the variation in the attained power of a stepped-wedge trial with unequal cluster sizes.,"BACKGROUND In a cross-sectional stepped-wedge trial with unequal cluster sizes, attained power in the trial depends on the realized allocation of the clusters. This attained power may differ from the expected power calculated using standard formulae by averaging the attained powers over all allocations the randomization algorithm can generate. We investigated the effect of design factors and allocation characteristics on attained power and developed models to predict attained power based on allocation characteristics. METHOD Based on data simulated and analyzed using linear mixed-effects models, we evaluated the distribution of attained powers under different scenarios with varying intraclass correlation coefficient (ICC) of the responses, coefficient of variation (CV) of the cluster sizes, number of cluster-size groups, distributions of group sizes, and number of clusters. We explored the relationship between attained power and two allocation characteristics: the individual-level correlation between treatment status and time period, and the absolute treatment group imbalance. When computational time was excessive due to a scenario having a large number of possible allocations, we developed regression models to predict attained power using the treatment-vs-time period correlation and absolute treatment group imbalance as predictors. RESULTS The risk of attained power falling more than 5% below the expected or nominal power decreased as the ICC or number of clusters increased and as the CV decreased. Attained power was strongly affected by the treatment-vs-time period correlation. The absolute treatment group imbalance had much less impact on attained power. The attained power for any allocation was predicted accurately using a logistic regression model with the treatment-vs-time period correlation and the absolute treatment group imbalance as predictors. CONCLUSION In a stepped-wedge trial with unequal cluster sizes, the risk that randomization yields an allocation with inadequate attained power depends on the ICC, the CV of the cluster sizes, and number of clusters. To reduce the computational burden of simulating attained power for allocations, the attained power can be predicted via regression modeling. Trial designers can reduce the risk of low attained power by restricting the randomization algorithm to avoid allocations with large treatment-vs-time period correlations.",2020,The risk of attained power falling more than 5% below the expected or nominal power decreased as the ICC or number of clusters increased and as the CV decreased.,[],[],"['responses, coefficient of variation (CV) of the cluster sizes, number of cluster-size groups, distributions of group sizes, and number of clusters']",[],[],"[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",,0.0385274,The risk of attained power falling more than 5% below the expected or nominal power decreased as the ICC or number of clusters increased and as the CV decreased.,"[{'ForeName': 'Yongdong', 'Initials': 'Y', 'LastName': 'Ouyang', 'Affiliation': 'School of Population and Public Health, University of British Columbia, 2206 E Mall, Vancouver, BC, V6T 1Z3, Canada. douyang@cheos.ubc.ca.'}, {'ForeName': 'Mohammad Ehsanul', 'Initials': 'ME', 'LastName': 'Karim', 'Affiliation': 'School of Population and Public Health, University of British Columbia, 2206 E Mall, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gustafson', 'Affiliation': 'Department of Statistics, University of British Columbia, 3182 Earth Science Building, 2207 Main Mall, Vancouver, BC, V6T 1Z4, Canada.'}, {'ForeName': 'Thalia S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'Vancouver Stroke Program, Faculty of Medicine, University of British Columbia, S169-2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': 'School of Population and Public Health, University of British Columbia, 2206 E Mall, Vancouver, BC, V6T 1Z3, Canada.'}]",BMC medical research methodology,['10.1186/s12874-020-01036-5'] 2887,32580710,"Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.","BACKGROUND Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care. METHODS One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 2 , treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice. DISCUSSION This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed. TRIAL REGISTRATION The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.",2020,This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D.,"['T2D patients from general practices in the Netherlands with a BMI\u2009≥\u200927\u2009kg/m 2 , treated with', 'T2D patients', 'One hundred', 'patients with type 2 diabetes']","['fasting-mimicking diet', 'lifestyle advice only or lifestyle advice plus metformin', 'FMD plus usual care or usual care only', 'FMD']","['anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice', 'HbA1c and T2D medication dosage', 'Fasting']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",100.0,0.101727,This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D.,"[{'ForeName': 'Elske L', 'Initials': 'EL', 'LastName': 'van den Burg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands. e.l.van_den_burg@lumc.nl.'}, {'ForeName': 'Marjolein P', 'Initials': 'MP', 'LastName': 'Schoonakker', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Petra G', 'Initials': 'PG', 'LastName': 'van Peet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'M Elske', 'Initials': 'ME', 'LastName': 'van den Akker-van Marle', 'Affiliation': 'Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Willems van Dijk', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Longo', 'Affiliation': 'FIRC Institute of Molecular Oncology, Milan, Italy.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Mattijs E', 'Initials': 'ME', 'LastName': 'Numans', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}]",BMC endocrine disorders,['10.1186/s12902-020-00576-7'] 2888,32580719,"Caregiver and community perceptions and experiences participating in an infant malaria prevention trial of PfSPZ Vaccine administered by direct venous inoculation: a qualitative study in Siaya County, western Kenya.","BACKGROUND Despite available control strategies, malaria morbidity and mortality, especially in infants and young children in sub-Saharan Africa, remain intractable. Malaria vaccination could substantially reduce malaria episodes and deaths. One vaccine candidate is the whole sporozoite PfSPZ Vaccine, consisting of irradiated cryopreserved sporozoites administered by direct venous inoculation (DVI). DVI may be less acceptable than more familiar administration routes, particularly intramuscular. As part of a PfSPZ Vaccine trial among infants in western Kenya, a qualitative study was conducted to explore caregiver and community perceptions of the malaria vaccine trial, including the unique DVI administration procedure. METHODS Twelve focus groups and 28 in-depth interviews explored perceptions of the DVI procedure in infants, factors influencing trial acceptability, and barriers to sustained trial participation. Purposively sampled participants included mothers of enrolled children, fathers and mothers who withdrew their children from the trial, village elders, and study clinicians from two trial enrollment sites. An iterative, multi-stage analytic approach, adapted from the Framework Method, was used to synthesize and interpret textual data. RESULTS Desires to prevent malaria and participation incentives (e.g., free consultations and medication) motivated caregivers to enroll their children in the trial. However, numerous factors also demotivated trial participation. Family members' (i.e., fathers') objections to required blood draws were cited most frequently as drivers of early trial withdrawal, in many cases prior to receiving any vaccine. Among mothers whose children received PfSPZ Vaccine (or placebo), many spoke favourably of DVI administration, describing improved tolerability relative to intramuscularly administered immunizations. Other trial-related challenges cited by caregivers included negative interactions with study clinicians and perceived delays in administering trial procedures. CONCLUSIONS Despite high acceptance of DVI among caregivers whose children received PfSPZ Vaccine (or placebo), objections to trial procedures from other non-sensitized household and family members prompted early trial withdrawal and inhibited successful completion of trial procedures for some infants. Implications for future trials include targeting heads of household during sensitization and recruitment activities, as well as equipping trial staff to effectively respond to participant and community concerns regarding trial procedures.",2020,"Among mothers whose children received PfSPZ Vaccine (or placebo), many spoke favourably of DVI administration, describing improved tolerability relative to intramuscularly administered immunizations.","['infants and young children in sub-Saharan Africa, remain intractable', 'Siaya County, western Kenya', 'Twelve focus groups and 28 in-depth interviews explored perceptions of the DVI procedure in infants, factors influencing trial acceptability, and barriers to sustained trial participation', 'infants in western Kenya', 'Purposively sampled participants included mothers of enrolled children, fathers and mothers who withdrew their children from the trial, village elders, and study clinicians from two trial enrollment sites']","['PfSPZ Vaccine administered by direct venous inoculation', 'PfSPZ Vaccine\xa0(or placebo', 'PfSPZ Vaccine', 'PfSPZ Vaccine (or placebo']","['malaria episodes and deaths', 'tolerability relative']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.270162,"Among mothers whose children received PfSPZ Vaccine (or placebo), many spoke favourably of DVI administration, describing improved tolerability relative to intramuscularly administered immunizations.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Achieng', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rosen', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Reuben Yego', 'Initials': 'RY', 'LastName': 'Cherop', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria, Inc., Rockville, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Seder', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Oneko', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Steinhardt', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. iyp6@cdc.gov.'}]",Malaria journal,['10.1186/s12936-020-03293-7'] 2889,32580724,The clinical relevance of early identification and treatment of sleep disorders in mental health care: protocol of a randomized control trial.,"BACKGROUND Sleep disorders are a risk factor for developing a variety of mental disorders, have a negative impact on their remission rates and increase the risk of relapse. Early identification and treatment of sleep disorders is therefore of paramount importance. Unfortunately, in mental health care sleep disorders are often poorly recognized and specific treatment frequently occurs late or not at all. This protocol-paper presents a randomized controlled trial investigating the clinical relevance of early detection and treatment of sleep disorders in mental health care. The two aims of this project are 1) to determine the prevalence of sleep disorders in different mental disorders, and 2) to investigate the contribution of early identification and adequate treatment of sleep disorders in individuals with mental disorders to their sleep, mental disorder symptoms, general functioning, and quality of life. METHODS Patients newly referred to a Dutch mental health institute for psychiatric treatment will be screened for sleep disorders with the self-assessment Holland Sleep Disorders Questionnaire (HSDQ). Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder. Participants will be randomly assigned to two groups: Immediate sleep diagnostics and intervention (TAU+SI-T0), or delayed start of sleep intervention (TAU+SI-T1; 6 months after inclusion). The effect of sleep treatment as add-on to treatment as usual (TAU) will be tested with regard to sleep disorder symptoms, general functioning, and quality of life (in collaboration with a psychiatric sleep centre). DISCUSSION This trial will examine the prevalence of different sleep disorders in a broad range of mental disorders, providing information on the co-occurrence of specific sleep and mental disorders. Further, this study is the first to investigate the impact of early treatment of sleep disorders on the outcome of many mental disorders. Moreover, standard sleep interventions will be tailored to specific mental disorders, to increase their efficacy. The results of this trial may contribute considerably to the improvement of mental health care. TRIAL REGISTRATION This clinical trial has been retrospectively registered in the Netherlands Trial Register (NL8389; https://www.trialregister.nl/trial/8389) on February 2th, 2020.",2020,"Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder.","['individuals with mental disorders to their sleep, mental disorder symptoms, general functioning, and quality of life', 'sleep disorders in mental health care', 'Patients newly referred to a Dutch mental health institute for psychiatric treatment will be screened for sleep disorders with the self-assessment Holland Sleep Disorders Questionnaire (HSDQ']","['standard sleep interventions', 'Immediate sleep diagnostics and intervention (TAU+SI-T0), or delayed start of sleep intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",[],,0.0656405,"Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder.","[{'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Ter Heege', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'Mijnster', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Maaike M', 'Initials': 'MM', 'LastName': 'van Veen', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Gerdina H M', 'Initials': 'GHM', 'LastName': 'Pijnenborg', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gretha J', 'Initials': 'GJ', 'LastName': 'Boersma', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'Lancel', 'Affiliation': 'GGZ Drenthe Mental Health Institute, 9404 LA, Assen, The Netherlands. marike.lancel@ggzdrenthe.nl.'}]",BMC psychiatry,['10.1186/s12888-020-02737-3'] 2890,31305214,"Screening for a Simple and Effective Indicator of Insulin Resistance in Chinese Reproductive-Aged Women, with the Insulin Clamp Technique as a Reference.","Background: Applying the hyperinsulinemic-euglycemic clamp to estimate insulin resistance (IR) is accurate but time-consuming, so identifying a simple and effective index for IR is vitally important. The present study aimed to compare the lipid accumulation product (LAP), visceral adiposity index (VAI), body mass index (BMI), waist circumference (WC), homeostasis model assessment of insulin resistance (HOMA-IR), and Chinese visceral adiposity index (CVAI) using the hyperinsulinemic-euglycemic clamp as a reference and to screen a simple and effective indicator for IR in Chinese women of childbearing age. Methods: The present study included a cross-sectional study of 537 reproductive-aged women and an interventional study of 90 randomly chosen polycystic ovarian syndrome (PCOS) women. Physical, laboratory, and hyperinsulinemic-euglycemic clamp were completed, and the BMI, WC, LAP, VAI, CVAI, and HOMA-IR were calculated. A linear correlation and a receiver operating characteristic curve were performed. After intervention with metformin, the effects were estimated in the third month. Results: PCOS women had worse glycometabolism, serum lipid metabolism and IR, and higher prevalence rates of metabolic disorders than those without PCOS. The CVAI was strongly associated with the M value ( r  = -0.6953, P  < 0.0001) and outperformed other parameters with the largest area under the curve (0.903) and Youden index (71.07%) for IR diagnosis in Chinese reproductive-aged women, and the diagnostic point was >28.5. After 3 months of metformin therapy, IR improved with remarkable increases in M value and reductions in the CVAI. Conclusion: The CVAI can be used as an appropriate surrogate indicator for the hyperinsulinemic-euglycemic clamp to identify IR in Chinese women of childbearing age. The interventional trial part of this study has been registered as a clinical trial (no. ChiCTR-IIR-16007901).",2019,"PCOS women had worse glycometabolism, serum lipid metabolism and IR, and higher prevalence rates of metabolic disorders than those without PCOS.","['Chinese women of childbearing age', 'Chinese Reproductive-Aged Women', '537 reproductive-aged women and an interventional study of 90 randomly chosen polycystic ovarian syndrome (PCOS) women']","['hyperinsulinemic-euglycemic clamp', 'metformin']","['BMI, WC, LAP, VAI, CVAI, and HOMA-IR', 'Physical, laboratory, and hyperinsulinemic-euglycemic clamp', 'M value', 'lipid accumulation product (LAP), visceral adiposity index (VAI), body mass index (BMI), waist circumference (WC), homeostasis model assessment of insulin resistance (HOMA-IR), and Chinese visceral adiposity index (CVAI', 'worse glycometabolism, serum lipid metabolism and IR']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0083089', 'cui_str': 'IVA protocol'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3658347', 'cui_str': 'Lipid Accumulation Product'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",90.0,0.0295445,"PCOS women had worse glycometabolism, serum lipid metabolism and IR, and higher prevalence rates of metabolic disorders than those without PCOS.","[{'ForeName': 'Jiangchuan', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lingou', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Gangyi', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Dongfang', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Metabolic syndrome and related disorders,['10.1089/met.2019.0019'] 2891,31810517,Stop the bleed: The impact of trauma first aid kits on post-training confidence among community members and medical professionals.,"INTRODUCTION Bystander training to control life-threatening hemorrhage is an important intervention to decrease preventable trauma deaths. We asked if receiving a trauma first aid (TFA) kit in addition to Bleeding Control (BC) 1.0 training improves self-reported confidence among community members (CM) and medical professionals (MP). METHODS Anonymous pre- and post-course surveys assessed exposure to severe bleeding, BC knowledge, and willingness to intervene with and without TFA kits. Surveys were compared using chi-squared tests. RESULTS 80 CM and 60 MP underwent BC training. Both groups demonstrated improved confidence in their ability to stop severe bleeding after the class; however, post-class confidence was significantly modified by receiving a TFA kit. After training, CM confidence was 36.1% without versus 57.0% with a TFA kit(p = 0.008) and MP confidence was 53.8% without versus 87.6% with a TFA kit(p = 0.001). CONCLUSION Receiving a TFA kit was significantly associated with increased post-training confidence among CM and MP. SUMMARY Stop the Bleed training improves confidence in stopping severe bleeding among both medical professionals and community members. By providing participants with a trauma first aid kit, post-class confidence improves significantly regardless of medical training.",2020,"After training, CM confidence was 36.1% without versus 57.0% with a TFA kit(p = 0.008) and MP confidence was 53.8% without versus 87.6% with a TFA kit(p = 0.001). ","['community members and medical professionals', 'community members (CM) and medical professionals (MP']","['Bleed training', 'Bystander training']","['severe bleeding, BC knowledge, and willingness to intervene with and without TFA kits', 'CM confidence', 'confidence in their ability to stop severe bleeding', 'MP confidence']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",,0.0298185,"After training, CM confidence was 36.1% without versus 57.0% with a TFA kit(p = 0.008) and MP confidence was 53.8% without versus 87.6% with a TFA kit(p = 0.001). ","[{'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Andrade', 'Affiliation': 'Department of Surgery, Washington University in St. Louis School of Medicine, St. Louis, MO, USA. Electronic address: andradee@wustl.edu.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Hayes', 'Affiliation': 'Department of Surgery, Washington University in St. Louis School of Medicine, St. Louis, MO, USA. Electronic address: janehayes@wustl.edu.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Punch', 'Affiliation': 'Department of Surgery, Washington University in St. Louis School of Medicine, St. Louis, MO, USA. Electronic address: ljpunch@wustl.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.11.028'] 2892,31811480,"Efficacy of oral administration of cystine and theanine in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery: a multi-institutional, randomized, double-blinded, placebo-controlled, phase II trial (JORTC-CAM03).","PURPOSE Capecitabine-based adjuvant chemotherapy for colorectal cancer patients often causes adverse events (AEs), such as diarrhea, stomatitis, anorexia, and hand-foot syndrome (HFS). Cystine and theanine were reported to attenuate some chemotherapy-associated AEs, and hence are also expected to attenuate capecitabine-induced AEs. Therefore, we aimed to investigate the safety and efficacy of cystine/theanine treatment in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery. METHODS A total of 100 colorectal cancer patients treated with capecitabine as an adjuvant chemotherapy after surgery were randomly allocated into the cystine/theanine group (n = 52) or the placebo group (n = 48). The primary endpoint was incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE) v.4.0, Japanese Clinical Oncology Group (JCOG) version. The secondary endpoints included incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale. RESULTS There were no significant differences in capecitabine-induced AEs between the two groups. However, the incidence rate of diarrhea of grade 1 or higher tended to be lower in the cystine/theanine group than the placebo group (18.4% vs. 28.9%, p = 0.169) as well as the incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale) (67.4% vs. 77.8%, p = 0.185, 67.3% vs. 80.0%, p = 0.124, respectively). CONCLUSION This trial demonstrated that cystine/theanine treatment of colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery is safe and has the tendency to reduce the incidence rate of diarrhea or HFS. TRIAL REGISTRATION UMIN000024784.",2020,There were no significant differences in capecitabine-induced AEs between the two groups.,"['100 colorectal cancer patients treated with', 'colorectal cancer patients undergoing', 'as an adjuvant chemotherapy after surgery', 'colorectal cancer patients', 'colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery']","['Cystine and theanine', 'capecitabine-based adjuvant chemotherapy', 'cystine/theanine treatment', 'capecitabine', 'Capecitabine-based adjuvant chemotherapy', 'cystine and theanine', 'cystine/theanine', 'placebo']","['incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE', 'incidence rate of diarrhea', 'safety and efficacy', 'incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale', 'incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1274034', 'cui_str': 'Clinical oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",100.0,0.573596,There were no significant differences in capecitabine-induced AEs between the two groups.,"[{'ForeName': 'Reo', 'Initials': 'R', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan. reo-h@nifty.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Gastroenterological Surgery, Sendai City Medical Center, Sendai Open Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Miyata', 'Affiliation': 'Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, Morioka, Iwate, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Colorectal Surgery, Tohoku Rosai Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': 'Department of Surgery, Miyagi Cancer Center, Sendai, Miyagi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Oshio', 'Affiliation': 'Department of Surgery, Sendai Medical Center, Sendai, Miyagi, Japan.'}, {'ForeName': 'Hisatsugu', 'Initials': 'H', 'LastName': 'Ohori', 'Affiliation': 'Department of Clinical Oncology, Ishinomaki Red Cross Hospital, Ishinomaki, Miyagi, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ariyoshi', 'Affiliation': 'JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oyamada', 'Affiliation': 'JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwase', 'Affiliation': 'Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05205-1'] 2893,31811485,"Quality of life in pediatric oncology patients, caregivers and siblings after psychosocial screening: a randomized controlled trial.","OBJECTIVE We evaluated whether conducting psychosocial screening using a validated measure (the Psychosocial Assessment Tool, PAT) and providing a summary of PAT results to the patient's treating team improves quality of life (QOL) in newly diagnosed patients with cancer, their caregivers and siblings, in general, and in relation to the initial family psychosocial risk. METHODS Families were randomly allocated to an intervention (IG, treating team received PAT summary describing low, medium, or high psychosocial risk) or control group (CG, no summary provided to treating team) in two Canadian pediatric cancer centers. Caregivers (N = 122) of children newly diagnosed with cancer, patients (n = 36), and siblings (n = 25) completed QOL assessments at 2-4 weeks (T1) and 6 months post-diagnosis (T2). Caregivers also completed PAT and proxy QOL for patient and sibling. RESULTS In general, patient-proxy total QOL improved in IG compared to CG over time but only for high psychosocial risk patients (p < .05). Patient proxy cancer-related QOL improved over time regardless of group allocation; caregiver QOL also improved over time (ps < .05). CONCLUSION This study demonstrated the benefits of psychosocial screening results only on proxy patient QOL outcomes with high psychosocial risk near diagnosis. Evaluating QOL benefits in pediatric oncology patients is critical for establishing the clinical value of psychosocial screening. CLINICAL TRIAL REGISTRATION NUMBER NCT02788604 (REGISTERED WITH HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT02788604 ).",2020,"In general, patient-proxy total QOL improved in IG compared to CG over time but only for high psychosocial risk patients (p < .05).","['Families', 'Caregivers (N = 122) of children newly diagnosed with cancer, patients (n = 36), and siblings (n = 25) completed', 'pediatric oncology patients, caregivers and siblings after psychosocial screening', 'pediatric oncology patients', 'proxy patient QOL outcomes with high psychosocial risk near diagnosis', 'newly diagnosed patients with cancer, their caregivers and siblings, in general, and in relation to the initial family psychosocial risk', 'two Canadian pediatric cancer centers']","['intervention (IG, treating team received PAT summary describing low, medium, or high psychosocial risk) or control group (CG, no summary provided to treating team', 'psychosocial screening using a validated measure (the Psychosocial Assessment Tool, PAT']","['Patient proxy cancer-related QOL', 'quality of life (QOL', 'Quality of life', 'QOL assessments', 'patient-proxy total QOL']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.100382,"In general, patient-proxy total QOL improved in IG compared to CG over time but only for high psychosocial risk patients (p < .05).","[{'ForeName': 'Maru', 'Initials': 'M', 'LastName': 'Barrera', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada. maru.barrera@sickkids.ca.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hancock', 'Affiliation': 'Psychology Department, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada.'}, {'ForeName': 'Eshetu', 'Initials': 'E', 'LastName': 'Atenafu', 'Affiliation': 'Biostatistics Department, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Aden', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Psychology Department, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada.'}, {'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Desjardins', 'Affiliation': 'Psychology Department, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shama', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': ""Psychology Department, British Columbia Women and Children's Hospital, Vancouver, Canada.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05160-x'] 2894,31823057,Benefits of using the Brief Pain Inventory in patients with cancer pain: an intervention study conducted in Swedish hospitals.,"PURPOSE The prevalence of cancer pain is too high. There is a need for improvement of pain management in cancer care. The aim of this study was to explore whether the use of the multidimensional pain assessment questionnaire Brief Pain Inventory (BPI) could improve pain relief in hospitalized patients with cancer. METHODS A controlled intervention study was performed at two hospitals in western Sweden, 264 patients were included, 132 formed a control group and 132 an intervention group. All participants completed the BPI and the Edmonton Symptom Assessment Scale (ESAS) at baseline. Only the researcher had access to questionnaires from the control group. The completed forms from the intervention group were presented to the patients' care team. A follow-up took place after 2-5 days when patients in both groups rated the scales a second time. RESULTS In the intervention group, significant differences in all measured items of the BPI were found at follow-up compared with baseline. Symptoms rated with the ESAS also decreased significantly, except shortness of breath. At follow-up, a significant increase in regular use of paracetamol, anti-neuropathic pain drugs and opioids was found, as well as elevated doses of fixed-schedule opioids. In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h. CONCLUSION Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly. A possible explanation for the results is changes in the medication prescribed.",2020,"In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h. CONCLUSION Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly.","['patients with cancer pain', 'two hospitals in western Sweden, 264 patients were included, 132 formed a control group and 132 an intervention group', 'hospitalized patients with cancer', 'Swedish hospitals']","['Brief Pain Inventory', 'multidimensional pain assessment questionnaire Brief Pain Inventory (BPI']","['regular use of paracetamol, anti-neuropathic pain drugs and opioids', 'pain relief', 'BPI', 'average pain and worst pain', 'except shortness of breath', 'BPI and the Edmonton Symptom Assessment Scale (ESAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",264.0,0.0362389,"In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h. CONCLUSION Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly.","[{'ForeName': 'Viveka', 'Initials': 'V', 'LastName': 'Andersson', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden. viveka.andersson@regionhalland.se.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bergman', 'Affiliation': 'Primary Health Care Unit, Department of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Henoch', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Simonsson', 'Affiliation': 'Department of Surgery, Hallands Hospital Halmstad, Lasarettsvägen, 302 42, Halmstad, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ahlberg', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05200-6'] 2895,31682574,Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial.,"BACKGROUND There is a paucity of controlled clinical trial data based on research with Indigenous peoples. A lack of data specific to Indigenous peoples means that new therapeutic methods, such as those involving electronic health (eHealth), will be extrapolated to these groups based on research with other populations. Rigorous, ethical research can be undertaken in collaboration with Indigenous communities but requires careful attention to culturally safe research practices. Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research. To be effective, researchers must first gain an in-depth understanding of Indigenous determinants of health, including the harmful consequences of colonialism. Second, researchers need to learn how colonialism affects the research process. The challenge then for eHealth researchers is to braid Indigenous ethical values with the requirements of good research methodologies into a culturally safe research protocol. OBJECTIVE A recent systematic review showed that Indigenous peoples are underrepresented in randomized controlled trials (RCTs), primarily due to a lack of attention to providing space for Indigenous perspectives within the study frameworks of RCTs. Given the lack of guidelines for conducting RCTs with Indigenous communities, we conducted an analysis of our large evaluation data set collected in the Diagnosing Hypertension-Engaging Action and Management in Getting Lower Blood Pressure in Indigenous Peoples and Low- and Middle- Income Countries (DREAM-GLOBAL) trial over a period of five years. Our goal is to identify wise practices for culturally safe, collaborative eHealth and RCT research with Indigenous communities. METHODS We thematically analyzed survey responses and qualitative interview/focus group data that we collected over five years in six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL. We established themes that reflect culturally safe approaches to research and then developed wise practices for culturally safe research in pragmatic eHealth research. RESULTS Based on our analysis, successful eHealth research in collaboration with Indigenous communities requires a focus on cultural safety that includes: (1) building a respectful relationship; (2) maintaining a respectful relationship; (3) good communication and support for the local team during the RCT; (4) commitment to co-designing the innovation; (5) supporting task shifting with the local team; and (6) reflecting on our mistakes and lessons learned or areas for improvement that support learning and cultural safety. CONCLUSIONS Based on evaluation data collected in the DREAM-GLOBAL RCT, we found that there are important cultural safety considerations in Indigenous eHealth research. Building on the perspectives of Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities. TRIAL REGISTRATION ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226.",2019,"Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research.","['Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities', 'With Indigenous People', 'six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL']",['DREAM-GLOBAL RCT'],[],"[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",[],,0.109044,"Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research.","[{'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'Maar', 'Affiliation': 'Faculty of Medicine, Northern Ontario School of Medicine, Laurentian University, Sudbury, ON, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Beaudin', 'Affiliation': ""M'Chigeeng Health Centre, M'Chigeeng First Nation, ON, Canada.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yeates', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Boesch', 'Affiliation': 'Department of Research, Northern Ontario School of Medicine, Sudbury, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Madjedi', 'Affiliation': 'Department of Medicine, Northern Ontario School of Medicine, Sudbury, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perkins', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hua-Stewart', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Beaudin', 'Affiliation': ""M'Chigeeng Health Centre, M'Chigeeng First Nation, ON, Canada.""}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Wabano', 'Affiliation': 'Naandwechige-Gamik Health Centre, Wiikwemkoong Unceded Territory, ON, Canada.'}, {'ForeName': 'Sheldon W', 'Initials': 'SW', 'LastName': 'Tobe', 'Affiliation': 'Faculty of Medicine, Northern Ontario School of Medicine, Laurentian University, Sudbury, ON, Canada.'}]",Journal of medical Internet research,['10.2196/14203'] 2896,31710304,Patients' Use of the Internet to Find Reliable Medical Information About Minor Ailments: Vignette-Based Experimental Study.,"BACKGROUND Little is known about the exact process of how patients search for medical information on the internet and what they retrieve. There is especially a paucity of literature on browsing for information on minor ailments, a term used for harmless diseases that are very common in the general population and thus have a significant impact on health care. OBJECTIVE This vignette-based experimental study aimed to explore what kind of Web-based search strategies are applied and how search strategies, demographic characteristics, and the quality of the visited websites relate to finding the right diagnosis. Additional goals were to describe how searching on the Web influences one's perception of the severity of the potential diagnosis and whether or not the participants would discuss the information they found on the internet with their doctors. METHODS Out of 1372 survey participants, 355 were randomly sampled, and 155 of them were recruited and assigned to one of four clinical scenarios. Each search term they used was classified as one of three search strategies: (1) hypothesis testing, (2) narrowing within the general hypothesis area, and (3) symptom exploration. The quality of the websites used was determined by using the DISCERN instrument. To compare the diagnostic accuracy of the participants before and after the internet search, a McNemar test was used. Chi-square tests were used to describe which factors are related to the chosen search strategy. A multivariate binary logistic regression model was constructed to predict which factors are related to finding a sound diagnosis after searching the internet for health information. RESULTS Most participants (65.8%, 102/155) used the symptom exploration strategy. However, this depends on the assigned scenario (P<.001) and the self-estimated severity score of the symptoms before the internet search (P=.001). A significant relation was found between choosing an accurate diagnosis and age (odds ratio [OR] 0.94, 95% CI 0.90 to 0.98) and the clinical scenario, as well as the use of high-quality websites (OR 7.49, 95% CI 1.85 to 30.26). Browsing the internet did not lead to a statistically significant change in participants' beliefs about the severity of the condition (McNemar test, P=.85). Most participants (65%) shared their retrieved information with their physician and most of them (75%) received a positive response. CONCLUSIONS Our findings suggest that most patients use a symptom-based approach; however, if patients expect the potential diagnosis to be severe, they tend to use a hypothesis verification strategy more often and are therefore prone to certain forms of bias. In addition, self-diagnosing accuracy is related to younger age, the symptom scenario, and the use of high-quality websites. We should find ways to guide patients toward search strategies and websites that may more likely lead to accurate decision making.",2019,"A multivariate binary logistic regression model was constructed to predict which factors are related to finding a sound diagnosis after searching the internet for health information. ","['Out of 1372 survey participants, 355 were randomly sampled, and 155 of them were recruited and assigned to one of four clinical scenarios']",[],"['symptom exploration strategy', 'diagnostic accuracy']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",1372.0,0.0255061,"A multivariate binary logistic regression model was constructed to predict which factors are related to finding a sound diagnosis after searching the internet for health information. ","[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Kwakernaak', 'Affiliation': 'Department Public Health & Primary Care, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Just A H', 'Initials': 'JAH', 'LastName': 'Eekhof', 'Affiliation': 'Department Public Health & Primary Care, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Margot W M', 'Initials': 'MWM', 'LastName': 'De Waal', 'Affiliation': 'Department Public Health & Primary Care, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Barenbrug', 'Affiliation': 'Consumentenbond, Den Haag, Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Department Public Health & Primary Care, Leiden University Medical Centre, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/12278'] 2897,31718757,Tuberculosis patients with higher levels of poverty face equal or greater costs of illness.,"SETTING: Fifty-six public clinics in Limpopo Province, South Africa. OBJECTIVE: To evaluate the association between tuberculosis (TB) patient costs and poverty as measured by a multidimensional poverty index. DESIGN: We performed cross-sectional interviews of consecutive patients with TB. TB episode costs were estimated from self-reported income, travel costs, and care-seeking time. Poverty was assessed using the South African Multidimensional Poverty Index (SAMPI) deprivation score (a 12-item household-level index), with higher scores indicating greater poverty. We used multivariable linear regression to adjust for age, sex, human immunodeficiency virus status and travel time. RESULTS: Among 323 participants, 108 (33%) were 'deprived' (deprivation score >0.33). For each 0.1-unit increase in deprivation score, absolute TB episode costs were 1.11 times greater (95%CI 0.97-1.26). TB episode costs were 1.19 times greater with each quintile of higher deprivation score (95%CI 1.00-1.40), but lower by a factor of 0.54 with each quintile of lower self-reported income (higher poverty, 95%CI 0.46-0.62). CONCLUSION: Individuals experiencing multidimensional poverty and the cost of tuberculosis illness in Limpopo, South Africa faced equal or higher costs of TB than non-impoverished patients. Individuals with lower self-reported income experienced higher costs as a proportion of household income but lower absolute costs. Targeted interventions are needed to reduce the economic burden of TB on patients with multidimensional poverty.",2019,"TB episode costs were 1.19 times greater with each quintile of higher deprivation score (95%CI 1.00-1.40), but lower by a factor of 0.54 with each quintile of lower self-reported income (higher poverty, 95%CI 0.46-0.62).","[' Fifty-six public clinics in Limpopo Province, South Africa', 'consecutive patients with TB', 'patients with multidimensional poverty', ""323 participants, 108 (33%) were 'deprived' (deprivation score >0.33"", 'Tuberculosis patients with higher levels of poverty face equal or greater costs of illness']",[],"['deprivation score, absolute TB episode costs', 'travel costs, and care-seeking time', 'South African Multidimensional Poverty Index (SAMPI) deprivation score', 'TB episode costs']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0162698', 'cui_str': 'Cost of Sickness'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",323.0,0.0369354,"TB episode costs were 1.19 times greater with each quintile of higher deprivation score (95%CI 1.00-1.40), but lower by a factor of 0.54 with each quintile of lower self-reported income (higher poverty, 95%CI 0.46-0.62).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Erlinger', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Stracker', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanrahan', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nonyane', 'Affiliation': 'Department of Epidemiology International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mmolawa', 'Affiliation': 'Perinatal HIV Research Unit, Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, South Africa.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tampi', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tucker', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'West', 'Affiliation': 'Department of Epidemiology International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lebina', 'Affiliation': 'Perinatal HIV Research Unit, Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, South Africa.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Martinson', 'Affiliation': 'Perinatal HIV Research Unit, Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, University of the Witwatersrand, South Africa, Johns Hopkins Center for Tuberculosis Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Department of Epidemiology International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, Johns Hopkins Center for Tuberculosis Research, Johns Hopkins University, Baltimore, MD, USA.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.18.0814'] 2898,31783136,Regulation effect and mechanism of Sheng-Hua-Tang on female reproductive system: From experimental transcriptomic analysis to clinical applications.,"ETHNOPHARMACOLOGICAL RELEVANCE Sheng-Hua-Tang (SHT) is commonly used to treat female illnesses, especially postpartum conditioning. However, its effects and mechanisms on female reproductive system remain unclear. The aim of the present study was to investigate the effect of SHT on female brain-ovary-uterus axis from bench to clinic. MATERIALS AND METHODS Mice were administrated SHT (200 mg/kg) orally for seven consecutive days. Brain, ovary, and uterus tissues were then collected for microarray analysis. A nationwide database analysis and a pilot randomized, open-label clinical trial were further applied to evaluate the clinical application and effects of SHT on postpartum women. RESULTS Microarray analysis showed that oral administration of SHT induced a cascade reaction of gene expression, with 17, 883, and 1592 genes were significantly regulated by SHT in brain, ovary, and uterus, respectively. Population-based analysis of one million subjects in Taiwan's National Health Insurance Research Database between 1997 and 2013 showed that SHT was commonly used in menstrual disorders in female population, especially dysmenorrhea, abnormal uterine bleeding, and variation of menstrual cycle. Clinical trial on postpartum women showed that oral administration SHT for one week alleviated uterine contraction pain and breast swelling pain. Furthermore, Mmp2, Mmp3, Mmp9, Mmp11, Mmp15, Oxtr, Plrl, and Tph2 gene expression affected by SHT in mice were correlated with clinical effects of SHT in human subjects. CONCLUSION This report provided the scientific evidences of mechanisms and clinical efficacies of SHT. Moreover, our findings might afford insights for clinical doctors in terms of SHT prescription.",2020,Clinical trial on postpartum women showed that oral administration SHT for one week alleviated uterine contraction pain and breast swelling pain.,"['postpartum women', ""Population-based analysis of one million subjects in Taiwan's National Health Insurance Research Database between 1997 and 2013 showed that SHT was commonly used in menstrual disorders in female population, especially dysmenorrhea, abnormal uterine bleeding, and variation of menstrual cycle"", 'female reproductive system', 'Mice were administrated']","['Hua-Tang (SHT', 'SHT', 'Sheng-Hua-Tang', 'oral administration SHT']","['Brain, ovary, and uterus tissues', 'cascade reaction of gene expression', 'uterine contraction pain and breast swelling pain']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C2932278', 'cui_str': 'Sheng-Hua-Tang'}, {'cui': 'C0025345', 'cui_str': 'Disorder of menstruation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0700038', 'cui_str': 'Female genital tract structure'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}]","[{'cui': 'C2932278', 'cui_str': 'Sheng-Hua-Tang'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0029939', 'cui_str': 'Ovarian structure'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006152', 'cui_str': 'Swelling of breast'}]",1000000.0,0.0696737,Clinical trial on postpartum women showed that oral administration SHT for one week alleviated uterine contraction pain and breast swelling pain.,"[{'ForeName': 'Jung-Miao', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': 'Graduate Institute of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan; Department of Chinese Medicine, Show Chwan Memorial Hospital, Changhua, 50008, Taiwan. Electronic address: rung-miau@hotmail.com.'}, {'ForeName': 'Chung-Chih', 'Initials': 'CC', 'LastName': 'Liao', 'Affiliation': 'Graduate Institute of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan. Electronic address: adzze1209@hotmal.com.'}, {'ForeName': 'Hui-Chi', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Chinese Pharmaceutical Sciences and Chinese Medicine Resources, China Medical University, Taichung, 40402, Taiwan. Electronic address: hchuang@mail.cmu.edu.tw.'}, {'ForeName': 'Cheng-Li', 'Initials': 'CL', 'LastName': 'Lin', 'Affiliation': 'Management Office for Health Data, China Medical University Hospital, Taichung, 40447, Taiwan; College of Medicine, China Medical University, Taichung, 40402, Taiwan. Electronic address: orangechengli@gmail.com.'}, {'ForeName': 'Hsin-Yi', 'Initials': 'HY', 'LastName': 'Lo', 'Affiliation': 'Graduate Institute of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan. Electronic address: hsinyilo0123@gmail.com.'}, {'ForeName': 'Chien-Yun', 'Initials': 'CY', 'LastName': 'Hsiang', 'Affiliation': 'Department of Microbiology and Immunology, China Medical University, Taichung, 40402, Taiwan. Electronic address: cyhsiang@mail.cmu.edu.tw.'}, {'ForeName': 'Tin-Yun', 'Initials': 'TY', 'LastName': 'Ho', 'Affiliation': 'Graduate Institute of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan; Department of Health and Nutrition Biotechnology, Asia University, Taichung, 41354, Taiwan. Electronic address: tyh@mail.cmu.edu.tw.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2019.112431'] 2899,32589630,Effect of tailoring anticoagulant treatment duration by applying a recurrence risk prediction model in patients with venous thromboembolism compared to usual care: A randomized controlled trial.,"BACKGROUND Patients with unprovoked (i.e., without the presence of apparent transient risk factors such as recent surgery) venous thromboembolism (VTE) are at risk of recurrence if anticoagulants are stopped after 3-6 months, yet their risk remains heterogeneous. Thus, prolonging anticoagulant treatment should be considered in high-risk patients, whereas stopping is likely preferred in those with a low predicted risk. The Vienna Prediction Model (VPM) could aid clinicians in estimating this risk, yet its clinical effects and external validity are currently unknown. The aim of this study was to investigate the clinical impact of this model on reducing recurrence risk in patients with unprovoked VTE, compared to usual care. METHODS AND FINDINGS In a randomized controlled trial, the decision to prolong or stop anticoagulant treatment was guided by predicted recurrence risk using the VPM (n = 441), which was compared with usual care (n = 442). Patients with unprovoked VTE were recruited from local thrombosis services in the Netherlands (in Utrecht, Harderwijk, Ede, Amersfoort, Zwolle, Hilversum, Rotterdam, Deventer, and Enschede) between 22 July 2011 and 30 November 2015, with 24-month follow-up complete for all patients by early 2018. The primary outcome was recurrent VTE during 24 months of follow-up. Secondary outcomes included major bleeding and clinically relevant non-major (CRNM) bleeding. In the total study population of 883 patients, mean age was 55 years, and 507 (57.4%) were men. A total of 96 recurrent VTE events (10.9%) were observed, 46 in the intervention arm and 50 in the control arm (risk ratio 0.92, 95% CI 0.63-1.35, p = 0.67). Major bleeding occurred in 4 patients, 2 in each treatment arm, whereas CRNM bleeding occurred in 20 patients (12 in intervention arm versus 8 in control arm). The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk. For instance, in 284 patients with a predicted risk of >2% to 4%, the observed rate of recurrence was 2.5% (95% CI 0.7% to 4.3%). The main limitation of this study is that it did not enroll the preplanned number of 750 patients in each study arm due to declining recruitment rate. CONCLUSIONS Our results show that application of the VPM in all patients with unprovoked VTE is unlikely to reduce overall recurrence risk. Yet, in those with a low predicted risk of recurrence, the observed rate was also low, suggesting that it might be safe to stop anticoagulant treatment in these patients. TRIAL REGISTRATION Netherlands Trial Register NTR2680.",2020,"The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk.","['284 patients', '883 patients, mean age was 55 years, and 507 (57.4%) were men', 'patients with venous thromboembolism compared to usual care', 'Patients with unprovoked VTE were recruited from local thrombosis services in the Netherlands (in Utrecht, Harderwijk, Ede, Amersfoort, Zwolle, Hilversum, Rotterdam, Deventer, and Enschede) between 22 July 2011 and 30 November 2015, with 24-month follow-up complete for all patients by early 2018', 'patients with unprovoked VTE, compared to usual care']",[],"['CRNM bleeding', 'recurrence risk', 'recurrent VTE', 'major bleeding and clinically relevant non-major (CRNM) bleeding', 'overall recurrence risk', 'Major bleeding', 'rate of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",284.0,0.138641,"The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk.","[{'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Geersing', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Janneke M T', 'Initials': 'JMT', 'LastName': 'Hendriksen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Kit C', 'Initials': 'KC', 'LastName': 'Roes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Oudega', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Takada', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Roger E G', 'Initials': 'REG', 'LastName': 'Schutgens', 'Affiliation': 'Van Creveld Clinic, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Karel G M', 'Initials': 'KGM', 'LastName': 'Moons', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",PLoS medicine,['10.1371/journal.pmed.1003142'] 2900,32589632,"A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambaréné, Gabon.","BACKGROUND It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study compared these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné, Gabon. METHODS Participants presenting with uncomplicated scabies were randomized into either the Individual Treatment group, where only the affected participants received treatment, or the Household Treatment group, where all family members were treated in parallel to the affected participants regardless of signs and symptoms. The primary endpoint was clinical cure after 28 days; the secondary endpoint was the proportion of affected household members per household after 28 days. RESULTS After 28 days, from a total of 79 participants assessed, 67% (n = 53) were clinically cured; 59% (20/34) in the Individual Treatment group and 73% (33/45) in the Household Treatment group. Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17). For the secondary outcome, an effect of similar size was observed. CONCLUSIONS Our findings show that treating close contacts of persons affected by scabies may be beneficial to patients and contacts, however, the benefit was less pronounced than anticipated and further research is needed to definitively answer this question.",2020,"Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17).",['Participants presenting with uncomplicated scabies'],['topical benzyl benzoate'],['clinical cure'],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0053289', 'cui_str': 'benzyl benzoate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}]",53.0,0.160026,"Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Matthewman', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Rella Zoleko', 'Initials': 'RZ', 'LastName': 'Manego', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Lia Betty', 'Initials': 'LB', 'LastName': 'Dimessa Mbadinga', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Šinkovec', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Institute of Clinical Biometrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Völker', 'Affiliation': 'Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine, & I Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Akinosho', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Haedrich', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': ""Tardif d'Hamonville"", 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Ayola Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ramharter', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Ghyslain', 'Initials': 'G', 'LastName': 'Mombo-Ngoma', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008423'] 2901,32589648,"Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study).","Despite the availability of effective antimicrobials, tuberculosis (TB) is still a serious health threat. Mortality is even higher in people living with HIV who are diagnosed with TB. New therapies are needed to shorten the time required to cure TB and decrease fatality rates in this population. N-acetylcysteine (NAC) is a glutathione precursor and has shown recently in experimental setting to present in vitro and in vivo anti-mycobacterial activity. We test the hypothesis that NAC is safe, well tolerated and secondarily efficacious as adjunctive anti-TB therapy in hospitalized individuals with HIV-associated TB. Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon. We performed a randomized, parallel group, single-center, open study trial of two arms, in hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC Group). A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively. Adverse event rates were similar in the two arms. Our findings suggest that in the more critical population of hospitalized patients with HIV-associated TB, the use of NAC was not unsafe, despite the low sample size, and a potential impact on faster negative cultures needs to be further explored in larger studies.",2020,Adverse event rates were similar in the two arms.,"['hospitalized individuals with HIV-associated TB', 'hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with', 'Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon', 'A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively', 'people living with HIV who are diagnosed with TB', 'hospitalized patients with HIV-associated tuberculosis']","['NAC', 'N-acetylcysteine (NAC', 'N-acetylcysteine', 'rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC']","['Adverse event rates', 'Safety and efficacy', 'Mortality']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",21.0,0.095281,Adverse event rates were similar in the two arms.,"[{'ForeName': 'Izabella Picinin', 'Initials': 'IP', 'LastName': 'Safe', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vitoria Silva', 'Initials': 'VS', 'LastName': 'Printes', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Adriana Ferreira', 'Initials': 'AF', 'LastName': 'Praia Marins', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Amanda Lia', 'Initials': 'AL', 'LastName': 'Rebelo Rabelo', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Amanda Araújo', 'Initials': 'AA', 'LastName': 'Costa', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Michel Araújo', 'Initials': 'MA', 'LastName': 'Tavares', 'Affiliation': 'Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Jaquelane Silva', 'Initials': 'JS', 'LastName': 'Jesus', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Alexandra Brito', 'Initials': 'AB', 'LastName': 'Souza', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Beraldi-Magalhães', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Cynthia Pessoa', 'Initials': 'CP', 'LastName': 'Neves', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Eduardo P', 'Initials': 'EP', 'LastName': 'Amaral', 'Affiliation': 'Immunobiology Section, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Renata Spener', 'Initials': 'RS', 'LastName': 'Gomes', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Bruno B', 'Initials': 'BB', 'LastName': 'Andrade', 'Affiliation': 'Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz (FIOCRUZ), Salvador, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cordeiro-Santos', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}]",PloS one,['10.1371/journal.pone.0235381'] 2902,32589670,"Does the type of foam roller influence the recovery rate, thermal response and DOMS prevention?","PURPOSE Supporting post-exercise recovery requires choosing not only the right treatment but also the equipment, in which the impact is not always clear. The study aimed to determine the effect of foam rolling on the rate of lactate removal and DOMS prevention and whether the type of foam roller is effective in the context of post-exercise recovery. METHODS This randomized trial enrolled 33 active healthy males divided into three groups of eleven individuals: foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS). All the participants performed full squat jumps for one minute. Examination took place at rest (thermal imaging of skin temperature-[Tsk] and blood lactate-[LA]), immediately following exercise (Tsk & LA), immediately after recovery treatment (Tsk) and after 30 minutes of rest (Tsk & LA). Their pain levels were assessed using the Visual Analog Scale (VAS) 24, 48, 72, and 96 hours after exercise. RESULTS The magnitude of lactate decrease depended on the type of recovery used. In the PAS group, the decrease in lactate concentration by 2.65 mmol/L following a half-hour rest was significantly lower than that in the other groups (STH vs. PAS p = 0.042 / GRID vs. PAS p = 0.025). For thermal responses, significant differences between both experimental groups were noted only 30 minutes after exercise. A significant decrease in pain in the STH group occurred between 48 and 96 hours, while the GRID group showed a systematic significant decrease in VAS values in subsequent measurements. Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05). CONCLUSIONS Foam rolling seems to be effective for enhancing lactate clearance and counteracting DOMS, but the type of foam roller does not seem to influence the recovery rate.",2020,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05). ",['33 active healthy males divided into three groups of eleven individuals'],['foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS'],"['VAS values', 'lactate concentration', 'pain levels', 'recovery rate, thermal response and DOMS prevention', 'pain']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",33.0,0.0430707,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05). ","[{'ForeName': 'Jakub Grzegorz', 'Initials': 'JG', 'LastName': 'Adamczyk', 'Affiliation': 'Theory of Sport Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Gryko', 'Affiliation': 'Athletics and Team Sport Games Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Boguszewski', 'Affiliation': 'Rehabilitation Department, Physiotherapy Division, Medical University of Warsaw, Warsaw, Poland.'}]",PloS one,['10.1371/journal.pone.0235195'] 2903,32589686,Optimal priming of poxvirus vector (NYVAC)-based HIV vaccine regimens for T cell responses requires three DNA injections. Results of the randomized multicentre EV03/ANRS VAC20 Phase I/II Trial.,"DNA vectors have been widely used as a priming of poxvirus vaccine in prime/boost regimens. Whether the number of DNA impacts qualitatively or quantitatively the immune response is not fully explored. With the aim to reinforce T-cell responses by optimizing the prime-boost regimen, the multicentric EV03/ANRS VAC20 phase I/II trial, randomized 147 HIV-negative volunteers to either 3xDNA plus 1xNYVAC (weeks 0, 4, 8 plus 24; n = 74) or to 2xDNA plus 2xNYVAC (weeks 0, 4 plus 20, 24; n = 73) groups. T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049). In the 3xDNA arm, 26 (37%) recipients developed a broader T-cell response (Env plus at least to one of the Gag, Pol, Nef pools) than in the 2xDNA (15; 22%) arms (primary endpoint; P = 0.047) with a higher magnitude against Env (at week 26) (P<0.001). In both groups, vaccine regimens induced HIV-specific polyfunctional CD4 and CD8 T cells and the production of Th1, Th2 and Th17/IL-21 cytokines. Antibody responses were also elicited in up to 81% of vaccines. A higher percentage of IgG responders was noted in the 2xDNA arm compared to the 3xDNA arm, while the 3xDNA group tended to elicit a higher magnitude of IgG3 response against specific Env antigens. We show here that the modulation of the prime strategy, without modifying the route or the dose of administration, or the combination of vectors, may influence the quality of the responses.",2020,T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049).,['147 HIV-negative volunteers to either'],"['poxvirus vector (NYVAC)-based HIV vaccine regimens', '3xDNA plus 1xNYVAC', '2xDNA plus 2xNYVAC']","['Antibody responses', 'IgG responders', 'HIV-specific polyfunctional CD4 and CD8 T cells and the production of Th1, Th2 and Th17/IL-21 cytokines', 'broader T-cell response', 'T-cell responses (IFN-γ ELISPOT', 'IgG3 response']","[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032868', 'cui_str': 'Poxviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0020859', 'cui_str': 'Immunoglobulin IgG3'}]",147.0,0.0624733,T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049).,"[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lévy', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lacabaratz', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ellefsen-Lavoie', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Stöhr', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelièvre', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bart', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, Faculté de médecine Paris Descartes; Inserm, CIC 1417, F-CRIN I-REIVAC; Assistance Publique-Hôpitaux de Paris, CIC Cochin Pasteur, Paris, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Salzberger', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Wiedemann', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Surenaud', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Koelle', 'Affiliation': 'Department of Medicine & Department of Global Health, University of Washington, Fred Hutchinson Cancer Research Center Seattle, Washington, United States of America.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wolf', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Rieux', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Gottardo', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'EuroVacc Foundation, Lausanne, Switzerland.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Inserm, Bordeaux Population Health Research Center, UMR 1219, University Bordeaux, ISPED, CIC 1401-EC, Univ Bordeaux, Bordeaux, France.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Chêne', 'Affiliation': 'Inserm, Bordeaux Population Health Research Center, UMR 1219, University Bordeaux, ISPED, CIC 1401-EC, Univ Bordeaux, Bordeaux, France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}]",PLoS pathogens,['10.1371/journal.ppat.1008522'] 2904,32589939,Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial.,"PURPOSE We aimed to compare complication rates and functional outcomes in patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity. PATIENTS AND METHODS This international, multicenter randomized controlled trial included adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis. Patients were treated with either a combination of rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation for both fractures. The primary outcome was complications within 6 weeks after surgery. Secondary outcomes were complications within 3 months, Helkimo dysfunction index, and mandibular mobility at 6 weeks and 3 months after surgery. RESULTS Of the 315 patients enrolled, 158 were randomized to the mixed fixation group and 157 to the nonrigid fixation group. The overall complication rate at 6 weeks in the intention-to-treat population was 9.6% (95% confidence interval [CI], 5.3% to 15.6%) in the mixed fixation group and 7.8% (95% CI, 4.0% to 13.5%) in the nonrigid fixation group. With an unadjusted odds ratio of 1.25 (95% CI, 0.51 to 3.17), there were no statistically significant differences in complication rates between the 2 groups (P = .591). A multivariable model for complication risk at 6 weeks found no significant differences between treatment groups, but patients with moderate or severe displacement had a higher complication rate than those with no or minimal displacement (adjusted odds ratio, 4.58; 95% CI, 1.16 to 18.06; P = .030). There were no significant between-group differences in complication rates at 3 months. Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received. CONCLUSIONS A combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture has similar complication rates and functional outcomes to nonrigid fixation for both fractures.",2020,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received. ","['patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity', 'adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis', 'patients with bilateral mandibular fracture', '315 patients enrolled', 'Bilateral Mandibular Fractures']","['rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation', 'nonrigid fixation group', 'rigid and nonrigid fixation', 'Rigid and Nonrigid Fixation Versus Nonrigid Fixation']","['complication rates', 'Helkimo dysfunction index and mandibular mobility index', 'complication risk', 'overall complication rate', 'complications within 6\xa0weeks after surgery', 'complication rate', 'complications within 3\xa0months, Helkimo dysfunction index, and mandibular mobility', 'complication rates and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",315.0,0.151617,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received. ","[{'ForeName': 'Vivesh', 'Initials': 'V', 'LastName': 'Rughubar', 'Affiliation': 'Head, Clinical Unit, Maxillofacial and Oral Surgery, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Vares', 'Affiliation': 'Professor and Head of Chair of Surgical Dentistry & Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Priyadeshni', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Dentist, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Filipsky', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Creanga', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Hospital Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Alkhalil', 'Affiliation': 'Head, Department Oral and Maxillofacial Surgery and CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Kormi', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Päijät-Häme Central Hospital, Päijät-Häme Joint Authority of Health and Wellbeing, Lahti, Finland (currently), and, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Hanken', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Asklepios Hospital North, Faculty of Medicine, Semmelweis University Campus Hamburg, Hamburg, Germany (currently), and Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alvaro Rivero', 'Initials': 'AR', 'LastName': 'Calle', 'Affiliation': 'Assistant Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Wenko', 'Initials': 'W', 'LastName': 'Smolka', 'Affiliation': 'Senior Surgeon, Department of Oral & Maxillofacial Surgery, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Chief of Oral and Maxillofacial Surgery, Division of Oral and Maxillofacial Surgery, Mount Sinai Hospital, New York City, NY.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csáki', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Ministry of Defense Health Centre, Budapest, Hungary.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Sánchez-Aniceto', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez', 'Affiliation': 'Associate Professor and Program Director, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Carl-Peter', 'Initials': 'CP', 'LastName': 'Cornelius', 'Affiliation': 'Associate Professor, Ludwig-Maximilians University, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie, Munich, Germany.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Alani', 'Affiliation': 'Specialist, CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vlad', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Kontio', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ellis', 'Affiliation': 'Professor and Chair of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX. Electronic address: ellise3@uthscsa.edu.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.012'] 2905,32589977,"Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial.","BACKGROUND Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is an aggressive cancer with a median overall survival of less than 6 months. We aimed to assess the response to single-agent selinexor, an oral selective inhibitor of nuclear export, in patients with relapsed or refractory DLBCL who had no therapeutic options of potential clinical benefit. METHODS SADAL was a multicentre, multinational, open-label, phase 2b study done in 59 sites in 19 countries. Patients aged 18 years or older with pathologically confirmed diffuse large B-cell lymphoma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received two to five lines of previous therapies, and progressed after or were not candidates for autologous stem-cell transplantation were enrolled. Germinal centre B-cell or non-germinal centre B-cell tumour subtype and double or triple expressor status were determined by immunohistochemistry and double or triple hit status was determined by cytogenetics. Patients received 60 mg selinexor orally on days 1 and 3 weekly until disease progression or unacceptable toxicity. The study was initially designed to evaluate both 60 mg and 100 mg twice-weekly doses of selinexor; however, the 100 mg dose was discontinued in the protocol (version 7.0) on March 29, 2017, when an improved therapeutic window was observed at 60 mg. Primary outcome was overall response rate. The primary outcome and safety were assessed in all patients who received 60 mg selinexor under protocol version 6.0, or enrolled under protocol versions 7.0 or higher and received at least one dose of selinexor. This trial is registered at ClinicalTrials.gov, NCT02227251 (active but not enrolling). FINDINGS Between Oct 21, 2015, and Nov 2, 2019, 267 patients were randomly assigned, with 175 allocated to the 60 mg group and 92 to the discontinued 100 mg group. 48 patients assigned to the 60 mg group were excluded due to enrolment before version 6.0 of the protocol; the remaining 127 patients received selinexor 60 mg and were included in analyses of primary outcome and safety. The overall response rate was 28% (36/127; 95% CI 20·7-37·0); 15 (12%) achieved a complete response and 21 (17%) a partial response. The most common grade 3-4 adverse events were thrombocytopenia (n=58), neutropenia (n=31), anaemia (n=28), fatigue (n=14), hyponatraemia (n=10), and nausea (n=8). The most common serious adverse events were pyrexia (n=9), pneumonia (n=6), and sepsis (n=6). There were no deaths judged as related to treatment with selinexor. INTERPRETATION Single-drug oral selinexor induced durable responses and had a manageable adverse events profile in patients with relapsed or refractory DLBCL who received at least two lines of previous chemoimmunotherapy. Selinexor could be considered a new oral, non-cytotoxic treatment option in this setting. FUNDING Karyopharm Therapeutics Inc.",2020,The overall response rate was 28% (36/127; 95% CI 20·7-37·0); 15 (12%) achieved a complete response and 21 (17%) a partial response.,"['patients with relapsed or refractory DLBCL who received at least two lines of previous', '48 patients assigned to the 60 mg group were excluded due to enrolment before version 6.0 of the protocol; the remaining 127 patients received', 'n=31), anaemia (n=28), fatigue (n=14), hyponatraemia (n=10), and nausea (n=8', 'SADAL was a multicentre, multinational, open-label, phase 2b study done in 59 sites in 19 countries', 'patients with relapsed or refractory DLBCL who had no therapeutic options of potential clinical benefit', 'patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL', 'Between Oct 21, 2015, and Nov 2, 2019, 267 patients', 'Patients aged 18 years or older with pathologically confirmed diffuse large B-cell lymphoma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received two to five lines of previous therapies, and progressed after or were not candidates for autologous stem-cell transplantation were enrolled']","['Selinexor', 'chemoimmunotherapy', 'selinexor']","['overall response rate', 'neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855112', 'cui_str': 'Diffuse large B-cell lymphoma refractory'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",267.0,0.466967,The overall response rate was 28% (36/127; 95% CI 20·7-37·0); 15 (12%) achieved a complete response and 21 (17%) a partial response.,"[{'ForeName': 'Nagesh', 'Initials': 'N', 'LastName': 'Kalakonda', 'Affiliation': 'University of Liverpool, Liverpool, UK. Electronic address: nagesh.kalakonda@liverpool.ac.uk.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Maerevoet', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences, Division of Hematology, University of Torino, Turin, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Follows', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Goy', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Joost S P', 'Initials': 'JSP', 'LastName': 'Vermaat', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Hématologie Clinique, Dijon, France.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Hamad', 'Affiliation': ""St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia.""}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Cancer Center, Amsterdam, Netherlands.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Dr B R Ambedkar Institute Rotary Cancer Hospital AIIMS, New Delhi, India.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Choquet', 'Affiliation': 'Hôpital Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Gurion', 'Affiliation': 'Rabin Medical Centre, Petah Tiqwa, Israel; Tel Aviv University, Petah Tiqwa, Israel.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hill', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaeger', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sancho', 'Affiliation': 'ICO-IJC Hospital Universitari Germans Trias I Pujol, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schuster', 'Affiliation': 'Stony Brook University, Stony Brook NY, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Saint-Louis Hospital, Paris, France; Paris Diderot University, Paris, France.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'De la Cruz', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Teaching Hospital Mór Kaposi, Kaposvár, Hungary.'}, {'ForeName': 'Sourav', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Institute of Medical Sciences & SUM Hospital, Odisha, India.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Gent University Hospital, Gent Belgium.'}, {'ForeName': 'Theodoros P', 'Initials': 'TP', 'LastName': 'Vassilakopoulos', 'Affiliation': 'Laikon General Hospital National, Athens, Greece; Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Warzocha', 'Affiliation': 'Instytut Hematologii i Transfuzjologii, Warszawa, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Corona', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Jean-Richard', 'Initials': 'JR', 'LastName': 'Saint-Martin', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Landesman', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Shacham', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kauffman', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Den Neste', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Canales', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30120-4'] 2906,32590001,"A randomized trial of parenteral nutrition using a mixed lipid emulsion containing fish oil in infants of extremely low birth weight: Neurodevelopmental outcome at 12 and 24 months corrected age, a secondary outcome analysis.","OBJECTIVE To examine whether parenteral nutrition using a mixed lipid emulsion containing fish oil improves the neurodevelopmental outcomes of extremely low birth weight (ELBW) infants. STUDY DESIGN The study is a secondary outcome analysis of a double-blind randomized trial of 230 ELBW infants performed at a single level IV neonatal care unit (Medical University Vienna; 06/2012-06/2015). Participants received either a mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil, or a soybean oil-based lipid emulsion for parenteral nutrition. Neurodevelopment of study participants was assessed at 12 and 24 months corrected age (08/2013-10/2017) using the Bayley Scales of Infant-Toddler Development, Third edition. RESULTS At discharge, 206/230 study participants were eligible. At 12 and 24 months corrected age, 174 out of 206 (85%) and 164 out of 206 (80%) infants were evaluated. At 12 months, there was no significant difference (median [interquartile range]) in cognitive (mixed lipid: 95 [85-101], soybean oil: 95 [85-100]; P=.71), language (mixed lipid: 86 [77-94], soybean oil: 89 [79-94]; P=.48) or motor scores (mixed lipid: 88 [76-94], soybean oil: 88 [79-94]; P=.69). At 24 months, there was again no significant difference in cognitive (mixed lipid: 95 [80-105], soybean oil: 95 [90-105]; P=.17), language (mixed lipid: 89 [75-97], soybean oil 89 [77-100]; P=.54) and motor scores (mixed lipid: 94 [82-103], soybean oil: 94 [85-103]; P=.53). CONCLUSION Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of ELBW infants at 12 and 24 months corrected age.",2020,Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of ELBW infants at 12 and 24 months corrected age.,"['230 ELBW infants performed at a single level IV neonatal care unit (Medical University Vienna; 06/2012-06/2015', 'infants of extremely low birth weight', 'extremely low birth weight (ELBW) infants', 'Neurodevelopment of study participants was assessed at 12 and 24 months corrected age (08/2013-10/2017) using the Bayley Scales of Infant-Toddler Development, Third edition']","['mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil, or a soybean oil-based lipid emulsion', 'parenteral nutrition', 'mixed lipid emulsion containing fish oil']",[],"[{'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]",[],230.0,0.224401,Parenteral nutrition using a mixed lipid emulsion containing fish oil did not improve neurodevelopment of ELBW infants at 12 and 24 months corrected age.,"[{'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Thanhaeuser', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Fuiko', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Oberleitner-Leeb', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Brandstaetter', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Binder', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Thajer', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Huber-Dangl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Eleonore', 'Initials': 'E', 'LastName': 'Pablik', 'Affiliation': 'Section for Medical Statistics, CeMSIIS, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Repa', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria. Electronic address: andreas.repa@meduniwien.ac.at.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.056'] 2907,32590010,Bacterial skin recolonization in the operating room: comparison between various antisepsis protocols.,"BACKGROUND Surgical site infection (SSI) largely implicates the patient's endogenous skin microbiota. Perioperative disinfection protocols do not follow a general agreement. AIM To compare antisepsis and skin protection protocols on quantitative analysis of recolonization in the operating room at regular time-steps. The study hypothesis was that one protocol would be more effective than others. METHODS A single-centre prospective interventional study was conducted between January and June 2019. Healthy volunteers were randomized between protocols and served as their own controls. The protocols began ahead of scheduled orthopaedic surgery with a preoperative shower, mechanical cleansing, application of major antiseptics (alcoholic Bétadine™ 5% or alcoholic chlorhexidine 0.5%), sterile draping, then adhesive draping (3M™ Steri-Drape™ or iodine-impregnated 3M™ Ioban2™). Sampling was by swabbing in the operating room at 30 min intervals up to 90 min after draping. Cultures were performed under aerobic and anaerobic conditions. Qualitative and quantitative (cfu/mL) bacteriology was performed in the laboratory by direct reading on the blood agar plates. FINDINGS Thirty subjects were included; none was lost to follow-up or excluded from analysis. Bacterial load before manipulation (T0) was significantly higher in males (P < 0.0001) despite a significantly shorter shower-to-sampling interval (P = 0.03). Smoking (P = 0.85), body mass index (P = 0.38), and depilation (P = 0.50) did not significantly affect preoperative load. Mean load increased significantly under all protocols up to T90 min, without significant superiority for any one protocol. Associated Bétadine™/Ioban™ showed the lowest T90 load, and chlorhexidine alone the highest, but without significant difference. Isolates at T0 were predominantly healthy skin commensals: coagulase-negative staphylococci, micrococci, and coryneforms. CONCLUSION No one protocol demonstrated superiority, whether in immediate bactericidal action or in preventing skin recolonization in the operating room. Further studies are needed to define generally agreed protocols for SSI risk management.",2020,"Associated Bétadine™/Ioban™ showed the lowest T90 load, and chlorhexidine alone the highest, but without significant difference.","['A single-centre prospective interventional study was conducted between January and June 2019', 'Thirty subjects were included; none was lost to follow-up or excluded from analysis', 'Healthy volunteers']","['Steri-Drape™ or iodine-impregnated 3M™ Ioban2™', 'chlorhexidine', 'scheduled orthopaedic surgery with a preoperative shower, mechanical cleansing, application of major antiseptics (alcoholic Bétadine™ 5% or alcoholic chlorhexidine 0.5%), sterile draping, then adhesive draping (3M™']","['body mass index', 'Qualitative and quantitative (cfu/mL', 'Mean load', 'Bacterial load before manipulation (T0', 'Bacterial skin recolonization', 'skin recolonization']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0950000', 'cui_str': 'Silene'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1275716', 'cui_str': 'Application of surgical drapes'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",30.0,0.0209764,"Associated Bétadine™/Ioban™ showed the lowest T90 load, and chlorhexidine alone the highest, but without significant difference.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Louis', 'Affiliation': 'Université Clermont Auvergne et Associés, Clermont Ferrand, France. Electronic address: lorouquett@gmail.com.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Traore', 'Affiliation': ""CHU Clermont Ferrand, Service d'Hygiène Hospitalière, Clermont Ferrand, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Descamps', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boisgard', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Villatte', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Erivan', 'Affiliation': ""Service d'Orthopédie-Traumatologie, Hôpital Gabriel Montpied, CHU de Clermont Ferrand BP 69, Clermont Ferrand, France.""}]",The Journal of hospital infection,['10.1016/j.jhin.2020.06.014'] 2908,32590049,"Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fracture.","Romosozumab (EVENITY™ [romosozumab-aqqg in the US]) is a humanized monoclonal antibody that inhibits sclerostin and has been approved in several countries for the treatment of osteoporosis in postmenopausal women at high risk of fracture. Sclerostin is expressed in bone and aortic vascular smooth muscle (AVSM). Its function in AVSM is unclear but it has been proposed to inhibit vascular calcification, atheroprogression, and inflammation. An increased incidence of positively adjudicated serious cardiovascular adverse events driven by an increase in myocardial infarction and stroke was observed in romosozumab-treated subjects in a clinical trial comparing alendronate with romosozumab (ARCH; NCT01631214) but not in a placebo-controlled trial (FRAME; NCT01575834). To investigate the effects of sclerostin inhibition with sclerostin antibody on the cardiovascular system, a comprehensive nonclinical toxicology package with additional cardiovascular studies was conducted. Although pharmacodynamic effects were observed in the bone, there were no functional, morphological, or transcriptional effects on the cardiovascular system in animal models in the presence or absence of atherosclerosis. These nonclinical studies did not identify evidence that proves the association between sclerostin inhibition and adverse cardiovascular function, increased cardiovascular calcification, and atheroprogression.",2020,"Although pharmacodynamic effects were observed in the bone, there were no functional, morphological, or transcriptional effects on the cardiovascular system in animal models in the presence or absence of atherosclerosis.",['postmenopausal women at high risk of fracture'],"['sclerostin inhibition with sclerostin antibody', 'romosozumab, an inhibitor of sclerostin', 'alendronate', 'Sclerostin', 'Romosozumab (EVENITY™ [romosozumab-aqqg']",['myocardial infarction and stroke'],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C4765894', 'cui_str': 'Evenity'}, {'cui': 'C4765888', 'cui_str': 'romosozumab-aqqg'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0719188,"Although pharmacodynamic effects were observed in the bone, there were no functional, morphological, or transcriptional effects on the cardiovascular system in animal models in the presence or absence of atherosclerosis.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Turk', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA. Electronic address: jturk@amgen.com.'}, {'ForeName': 'Aimee M', 'Initials': 'AM', 'LastName': 'Deaton', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Genome Analysis Unit, Amgen Research, South San Francisco, CA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Stolina', 'Affiliation': 'Cardiometabolic Disorders Research, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Felx', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Boyd', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Jean-Guy', 'Initials': 'JG', 'LastName': 'Bienvenu', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Varela', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Guillot', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Holdsworth', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wolfreys', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Dwyer', 'Affiliation': 'Cardiometabolic Disorders Research, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Sheetal V', 'Initials': 'SV', 'LastName': 'Kumar', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'de Koning', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engwall', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Locher', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, South San Francisco, CA, USA.'}, {'ForeName': 'Lucas D', 'Initials': 'LD', 'LastName': 'Ward', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Glaus', 'Affiliation': 'Cardiometabolic Disorders Research, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Yudong D', 'Initials': 'YD', 'LastName': 'He', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA; Genome Analysis Unit, Amgen Research, South San Francisco, CA, USA.'}, {'ForeName': 'Rogely Waite', 'Initials': 'RW', 'LastName': 'Boyce', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA.'}]",Regulatory toxicology and pharmacology : RTP,['10.1016/j.yrtph.2020.104697'] 2909,32590057,Maternal Mindfulness is associated with Lower Child Body Mass Index Z score.,"BACKGROUND Parental mindfulness may be a novel intervention target for child obesity prevention. OBJECTIVE To examine associations between maternal mindfulness and child body mass index z-score (BMIz). METHODS In a secondary data analysis of pre-intervention data from a randomized controlled trial, we assessed survey and anthropometric data from English-speaking mother/child dyads enrolled in Head Start in south central Michigan (n=105). Surveys included demographic information, child dietary intake, family meal frequency, and the Philadelphia Mindfulness Questionnaire. Multivariable linear regression examined associations between maternal mindfulness and child BMIz, child intake of fruits and vegetables, and frequency of family meals. RESULTS Children were M=53.7 (SD 7.5) months old, and mothers were M=31.6 (SD 8.3) years old. The sample of children was 39% white, 26% black, 14% Hispanic, and 35% of children were overweight or obese. Mean maternal BMI was 32.0 (SD 8.3). Greater mindfulness was associated with child BMIz (β=-0.02 (SE 0.01), p=.027) adjusting for child race/ethnicity, household food security, maternal education, maternal age, and maternal BMI. Mindfulness was not associated with child fruit intake, child vegetable intake or frequency of family meals. The results were consistent with alternative outcomes of BMI percentile (p=.016) and BMI at the trend level (p=.0595) at the trend level. CONCLUSIONS Greater maternal mindfulness was associated with lower child BMIz. Future work should consider mechanisms of association. Pediatric providers might consider supporting maternal mindfulness as one element of multicomponent strategies for child obesity prevention.",2020,"The results were consistent with alternative outcomes of BMI percentile (p=.016) and BMI at the trend level (p=.0595) at the trend level. ","['Children were M=53.7 (SD 7.5) months old, and mothers were M=31.6 (SD 8.3) years old', 'sample of children was 39% white, 26% black, 14% Hispanic, and 35% of children were overweight or obese', 'English-speaking mother/child dyads enrolled in Head Start in south central Michigan (n=105']",[],"['Lower Child Body Mass Index Z score', 'maternal mindfulness and child body mass index z-score (BMIz', 'demographic information, child dietary intake, family meal frequency, and the Philadelphia Mindfulness Questionnaire', 'maternal mindfulness and child BMIz, child intake of fruits and vegetables, and frequency of family meals', 'child fruit intake, child vegetable intake or frequency of family meals', 'Mean maternal BMI', 'child BMIz', 'BMI percentile']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",,0.0182683,"The results were consistent with alternative outcomes of BMI percentile (p=.016) and BMI at the trend level (p=.0595) at the trend level. ","[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, 1540 E Hospital Dr, Ann Arbor, MI 48109, United States. Electronic address: ochioma@med.umich.edu.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Brophy-Herb', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Dr, East Lansing, MI 48823, United States. Electronic address: hbrophy@msu.edu.'}, {'ForeName': 'Harlan', 'Initials': 'H', 'LastName': 'McCaffery', 'Affiliation': 'Center for Human Growth and Development, University of Michigan, 300 N Ingalls St, Ann Arbor, MI 48104, United States. Electronic address: hmccaff@umich.edu.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Struza', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, 1540 E Hospital Dr, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Dr, East Lansing, MI 48823, United States. Electronic address: will3208@msu.edu.'}, {'ForeName': 'Hailey Hyunjin', 'Initials': 'HH', 'LastName': 'Choi', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Dr, East Lansing, MI 48823, United States. Electronic address: choihy15@msu.edu.'}, {'ForeName': 'Mildred A', 'Initials': 'MA', 'LastName': 'Horodynski', 'Affiliation': 'College of Nursing, Michigan State University, 1355 Bogue St, East Lansing, MI, 48824, United States. Electronic address: millie@msu.edu.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Contreras', 'Affiliation': 'Michigan State University Extension, Michigan State University, 446 West Circle Drive, East Lansing, MI 48824, United States. Electronic address: contrer7@msu.edu.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kerver', 'Affiliation': 'Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, MI 48823, United States. Electronic address: jkerver@epi.msu.edu.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Center for Human Growth and Development, University of Michigan, 300 N Ingalls St, Ann Arbor, MI 48104, United States. Electronic address: nicola@med.umich.edu.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lumeng', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, 1540 E Hospital Dr, Ann Arbor, MI 48109, United States; Center for Human Growth and Development, University of Michigan, 300 N Ingalls St, Ann Arbor, MI 48104, United States; Department of Nutritional Sciences, University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, MI 48109, United States. Electronic address: jlumeng@umich.edu.'}]",Academic pediatrics,['10.1016/j.acap.2020.06.012'] 2910,32590064,Improving the Safety of Shoulder Arthroscopy in the Beach-Chair Position: A Prospective Randomized Trial Investigating the Effect of Compression Stockings on Cerebral Desaturation Events in High Risk Patients.,"BACKGROUND Devastating transient and permanent postoperative neurocognitive complications in previously healthy, low risk patients have been observed after elective shoulder arthroscopy in the beach chair position (BCP). Continuous monitoring of cerebral oxygen saturation has been recommended to identify cerebral desaturation events (CDEs) and improve patient safety. However, the relatively high cost and limited availability of monitoring may not be cost-effective. More cost-effective and available measures, including the use of thigh-high compression stockings (CS), have been investigated. However, efficacy data of CS usage is limited, especially for obese patients, who have been shown to be at increased risk for CDEs. The purpose of this was study was to determine if the intraoperative addition of thigh-high compression stockings decreases the incidence, frequency, and magnitude of CDEs in obese patients undergoing shoulder arthroscopy in the BCP. METHODS Thirty-three patients in the treatment group wore both thigh-high compression stockings (CS) and sequential compression devices (SCDs), and the remaining 33 patients in the control group wore SCDs alone. Cerebral oximetry was monitored during surgery using near-infrared spectroscopy. RESULTS The incidence of CDEs was equal between groups, with 9 patients (27%) in each experiencing desaturation events. The median number of CDEs per patient was 3 for the control group and 1 for patients wearing CS (p = 0.286). There was no difference between groups in terms of median time from induction of anesthesia to onset of CDE (p = 0.791), median time from upright positioning to onset of CDE (p = 0.596), mean CDE duration per patient (p = 0.216), and median cumulative CDE duration (p = 0.185). The median maximal desaturation from baseline was also not different between groups: 27.6% in the control group and 24.3% in the treatment group (p = 0.354). CONCLUSION The combination of thigh-high CS and SCDs did not decrease the incidence, frequency, or magnitude of CDEs in patients undergoing shoulder arthroscopy in the BCP. Twenty-seven percent of patients undergoing shoulder arthroscopy in the BCP demonstrated cerebral desaturation events with or without the use of CS. Therefore, further research is required to identify cost-effective, minimally invasive, and universally available methods of decreasing the incidence of CDEs during this common surgical procedure. LEVEL OF EVIDENCE Level I; Randomized Controlled Trial; Treatment Study.",2020,"The incidence of CDEs was equal between groups, with 9 patients (27%) in each experiencing desaturation events.","['previously healthy, low risk patients', 'obese patients undergoing shoulder arthroscopy in the BCP', 'High Risk Patients', 'obese patients', 'patients undergoing shoulder arthroscopy in the BCP']","['thigh-high compression stockings (CS) and sequential compression devices (SCDs', 'thigh-high compression stockings (CS', 'thigh-high compression stockings', 'Compression Stockings', 'control group wore SCDs alone', 'Shoulder Arthroscopy']","['incidence of CDEs', 'median time from induction of anesthesia to onset of CDE', 'incidence, frequency, or magnitude of CDEs', 'median number of CDEs', 'Cerebral Desaturation Events', 'median time from upright positioning to onset of CDE', 'incidence, frequency, and magnitude of CDEs', 'Cerebral oximetry', 'cerebral desaturation events', 'median cumulative CDE duration', 'mean CDE duration', 'median maximal desaturation']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}, {'cui': 'C2316745', 'cui_str': 'Beach chair position'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C2711456', 'cui_str': 'Intermittent pneumatic compression stockings'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0108844', 'cui_str': 'CDE protocol'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",33.0,0.112122,"The incidence of CDEs was equal between groups, with 9 patients (27%) in each experiencing desaturation events.","[{'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Golz', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 2160 South First Avenue, Maywood, IL 60153, USA. Electronic address: Andrew.Golz@lumc.edu.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davis', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 2160 South First Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Perry', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 2160 South First Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Pietro M', 'Initials': 'PM', 'LastName': 'Tonino', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 2160 South First Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Garbis', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 2160 South First Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Dane H', 'Initials': 'DH', 'LastName': 'Salazar', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 2160 South First Avenue, Maywood, IL 60153, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.05.037'] 2911,32590084,Blood transfusion and ischaemic outcomes according to anemia and bleeding in patients with non-ST-segment elevation acute coronary syndromes: Insights from the TAO randomized clinical trial.,"BACKGROUND The benefits and risks of blood transfusion in patients with acute myocardial infarction who are anemic or who experience bleeding are debated. We sought to study the association between blood transfusion and ischemic outcomes according to haemoglobin nadir and bleeding status in patients with NST-elevation myocardial infarction (NSTEMI). METHODS The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to heparin plus eptifibatide versus otamixaban. After exclusion of patients who underwent coronary artery bypass surgery, patients were categorized according to transfusion status considering transfusion as a time-varying covariate. The primary ischemic outcome was the composite of all-cause death or MI within 180 days of randomization. Subgroup analyses were performed according to pre-transfusion hemoglobin nadir and bleeding status. RESULTS 12,547 patients were enrolled. Among these, blood transfusion was used in 489 (3.9%) patients. Patients who received transfusion had a higher rate of death or MI (29.9% vs. 8.1%, p<0.01). This excess risk persisted after adjustment on GRACE score and nadir of hemoglobin (HR 3.36 95%CI 2.63-4.29 p<0.01). Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir > 9.0 g/dl (HR 4.01; p-interaction<0.0001). CONCLUSION In patients with NSTEMI, blood transfusion was associated with an overall increased risk of ischaemic events. However, this was mainly driven by patients without overt bleeding and those hemoglobin nadir > 9.0g/dl. This suggests possible harm of transfusion in those groups.",2020,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"['patients with NST-elevation myocardial infarction (NSTEMI', 'The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to', 'patients with acute myocardial infarction who are anemic or who experience bleeding are debated', 'patients with non-ST-segment elevation acute coronary syndromes', '12,547 patients were enrolled']","['blood transfusion', 'coronary artery bypass surgery', 'heparin plus eptifibatide versus otamixaban']","['anemia and bleeding', 'GRACE score and nadir of hemoglobin', 'risk of ischaemic events', 'composite of all-cause death or MI', 'Blood transfusion and ischaemic outcomes', 'rate of death or MI', 'blood transfusion', 'haemoglobin nadir and bleeding status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C1097497', 'cui_str': 'otamixaban'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",12547.0,0.115362,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Deharo', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France; Aix Marseille Univ, Inserm, Inra, C2VN, Marseille, France; Aix-Marseille Université, Faculté de Médecine, F-13385 Marseille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Diderot, Département Hospitalo-Universitaire FIRE, Sorbonne-Paris Cité, Paris, France; FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network,l: NHLI, Royal Brompton Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Heart Center Freiburg University, Cardiology and Angiology I, Faculty of Medicine, Freiburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Pollack', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Department of Cardiology, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Pilsonu Street 13, Riga, Latvia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Fondazione Cardiocentro Ticino, via Tesserete 48, 6900 Lugano, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Diderot, Département Hospitalo-Universitaire FIRE, Sorbonne-Paris Cité, Paris, France; FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network,l: NHLI, Royal Brompton Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Diderot, Département Hospitalo-Universitaire FIRE, Sorbonne-Paris Cité, Paris, France; FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network,l: NHLI, Royal Brompton Hospital, Imperial College, London, United Kingdom. Electronic address: gabriel.steg@aphp.fr.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.020'] 2912,32590137,Bone turnover markers in children living with HIV remaining on ritonavir-boosted lopinavir or switching to efavirenz.,"INTRODUCTION We previously found lower bone mass but similar bone turnover in pre-pubertal children living with HIV (CLWH) on a ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy regimen 2 years after switch. Here, we evaluate if bone turnover differed between the groups close to the time of switch. METHODS Samples from 108 children remaining on LPV/r and 104 children switched to efavirenz were available for analysis 8 weeks post-randomization. Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin were measured. Markers of immune activation were also measured, including IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP). RESULTS Eight weeks post-randomization, we did not detect differences in CTx (1.42 vs. 1.44 ng/mL, p = 0.85) or P1NP concentrations (622 vs. 513 ng/mL, p = 0.68) between treatment groups. At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP. Osteocalcin (ng/mL) was higher in the LPV/r than efavirenz group both at 8 weeks (88.6 vs. 67.3, p = 0.001) and 2 years (67.6 vs. 49.8, p = 0.001). CONCLUSIONS Overall, we failed to detect difference in bone turnover by P1NP and CTx in virologically-suppressed CLWH on different regimens at a time point close to the switch. We did observe higher levels of total osteocalcin in children remaining on LPV/r compared to children switched to efavirenz. Future studies should focus on uncovering the mechanism and determining whether perturbation in undercarboxylated osteocalcin could explain some of the bone side effects noted with protease inhibitors.",2020,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","['children living with HIV remaining on ritonavir-boosted lopinavir or switching to', 'Samples from 108 children remaining on LPV/r and 104 children switched to', 'pre-pubertal children living with HIV (CLWH) on a']","['efavirenz', 'ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy']","['IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP', 'Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin', 'levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP', 'Osteocalcin', 'bone turnover by P1NP and CTx', 'total osteocalcin', 'CTx', 'Bone turnover markers', 'bone turnover', 'P1NP concentrations', 'Markers of immune activation']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.0664262,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shiau', 'Affiliation': 'Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Yin', 'Affiliation': 'Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Strehlau', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Coovadia', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA. Electronic address: sma2@columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115500'] 2913,32590148,Physical and mental health effects of repeated short walks in a blue space environment: A randomised crossover study.,"INTRODUCTION Blue spaces may benefit mental health and promote physical activity, although the evidence is still scarce. And benefits on physical health are less consistent. The objective of this randomized crossover study was to assess psychological and cardiovascular responses to blue spaces' exposure. METHODS A sample of 59 healthy adult office workers was randomly assigned to a different environment (i.e. blue space, urban space, and control site) on 4 days each week, for 3 weeks. For 20 min per day, they either walked along a blue or an urban space or rested at a control site. Before, during and/or after the exposure, we measured self-reported well-being and mood, blood pressure, and heart rate variability parameters. For well-being, we also assessed the duration of these potential effects over time (at least 4 h after exposure). RESULTS We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site. Cardiovascular responses showed increased activity of the sympathetic nervous system, both during and after walking along the blue and urban spaces. However, cardiovascular responses measured after the walks, showed no statistically significant differences between the blue and the urban space environments. CONCLUSIONS Short walks in blue spaces can benefit both well-being and mood. However, we did not observe a positive effect of blue spaces for any of the cardiovascular outcomes assessed in this study.",2020,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,['59 healthy adult office workers'],[],"['psychological and cardiovascular responses', 'cardiovascular responses', 'self-reported well-being and mood, blood pressure, and heart rate variability parameters', 'well-being and mood responses', 'Physical and mental health effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",59.0,0.0763709,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vert', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Gascon', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Ranzani', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Márquez', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Triguero-Mas', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain; Institute for Environmental Science and Technology, Barcelona, Spain; IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Barcelona Lab for Urban Environmental Justice and Sustainability, Barcelona, Spain.'}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Carrasco-Turigas', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Arjona', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Llopis', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Donaire-Gonzalez', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Institute for Risk Assessment Sciences (IRAS), Division of Environmental Epidemiology (EEPI), Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Lewis R', 'Initials': 'LR', 'LastName': 'Elliott', 'Affiliation': 'European Centre for Environment and Human Health, University of Exeter Medical School, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nieuwenhuijsen', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: mark.nieuwenhuijsen@isglobal.org.'}]",Environmental research,['10.1016/j.envres.2020.109812'] 2914,32590151,Cryoballoon Ablation of Pulmonary Veins for Persistent Atrial Fibrillation: Results From the Multicenter STOP Persistent AF Trial.,"BACKGROUND Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF). OBJECTIVES To assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF. METHODS STOP Persistent AF (NCT03012841) was a prospective, multicenter, single-arm, FDA-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes < 6 months). The primary efficacy endpoint was 12-month freedom from ≥30 sec of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at >40% and <13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT and SF-12 questionnaires. RESULTS Of 186 total enrollments, 165 subjects (70% male, 65±9 years, left atrial diameter 4.2±0.6 cm, body mass index 31±6) were treated at 25 sites in the United States, Canada, and Japan. Total procedure, left atrial dwell, and fluoroscopy times were 121±46, 102±41, and 19±16 min, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% CI: 46.7%-62.1%) freedom from AF, AFL or AT. There was one primary safety event, translating to a rate of 0.6% (95% CI: 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P<0.001). CONCLUSIONS The STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes <6 months.",2020,"AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P<0.001). ","['Persistent Atrial Fibrillation', 'patients with symptomatic drug-refractory atrial fibrillation (AF', 'Of 186 total enrollments, 165 subjects (70% male, 65±9 years, left atrial diameter 4.2±0.6 cm, body mass index 31±6) were treated at 25 sites in the United States, Canada, and Japan']","['Cryoballoon Ablation of Pulmonary Veins', 'Pulmonary vein isolation (PVI', 'PVI-only cryoballoon ablation for drug-refractory persistent AF', 'PVI']","['Total procedure, left atrial dwell, and fluoroscopy times', 'safety and efficacy', 'quality of life using the AFEQT and SF-12 questionnaires', '12-month freedom from ≥30 sec of AF, atrial flutter (AFL), or atrial tachycardia (AT']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}]",,0.0320406,"AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P<0.001). ","[{'ForeName': 'Wilber W', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Banner University Medical Center Phoenix, AZ, USA.'}, {'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kabir', 'Initials': 'K', 'LastName': 'Bhasin', 'Affiliation': 'Northwell Health-Lenox Hill Heart and Lung, New York, NY, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Institut Universitaire de Cardiologie et du Pneumologie de Quebec, Quebec, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Sangrigoli', 'Affiliation': 'Doylestown Cardiology Associates, Doylestown, PA, USA.'}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Braegelmann', 'Affiliation': 'Medtronic, Inc., Minneapolis, MN, USA.'}, {'ForeName': 'Fred J', 'Initials': 'FJ', 'LastName': 'Kueffer', 'Affiliation': 'Medtronic, Inc., Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, Canada.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Health System, Kansas City, MO, USA.""}, {'ForeName': 'Teiichi', 'Initials': 'T', 'LastName': 'Yamane', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, MD, USA. Electronic address: hcalkins@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart rhythm,['10.1016/j.hrthm.2020.06.020'] 2915,32590214,Perceived social support and posttraumatic stress symptoms in children and youth in therapy: A parallel process latent growth curve model.,"Many studies show that perceived social support protects against the development of posttraumatic stress symptoms (PTSS) in the aftermath of trauma, but less is known about support in relation to PTSS in trauma therapy. This study examined associations between perceived social support and PTSS in children and adolescents during trauma therapy. Parallel process latent growth curve modeling was used to examine trajectories of perceived social support and PTSS over five measurement waves in a sample of 156 patients, aged between 10 and 18 years (M age = 15.1, SD = 2.2, 79.5% girls), randomized to receive trauma-focused cognitive behavior therapy (TF-CBT) or therapy-as-usual (TAU). Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy. Most of the change occurred during therapy and was maintained after therapy. Higher levels of PTSS prior to therapy were associated with lower levels of perceived social support prior to therapy, and a decrease in PTSS was associated with increase in perceived social support. This co-development may have been directed by a third underlying factor or short-term temporal effects. Studies investigating within-person associations over shorter time intervals will benefit our understanding of possible temporal effects.",2020,Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy.,"['children and adolescents during trauma therapy', '156 patients, aged between 10 and 18 years (M age\xa0=\xa015.1, SD\xa0=\xa02.2, 79.5% girls', 'children and youth in therapy']",['trauma-focused cognitive behavior therapy (TF-CBT) or therapy-as-usual (TAU'],"['Perceived social support and posttraumatic stress symptoms', 'PTSS', 'perceived social support']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1320387', 'cui_str': 'Trauma therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",156.0,0.02545,Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy.,"[{'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Birkeland', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway. Electronic address: Marianne.s.birkeland@gmail.com.'}, {'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Holt', 'Affiliation': 'Division of Mental & Physical Health, Norwegian Institute of Public Health, Norway.'}, {'ForeName': 'Silje M', 'Initials': 'SM', 'LastName': 'Ormhaug', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway.'}, {'ForeName': 'Tine K', 'Initials': 'TK', 'LastName': 'Jensen', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway; Department of Psychology, University of Oslo, Norway.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103655'] 2916,32590251,The treatment of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation.,"OBJECTIVES To compare the advantages and disadvantages of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO) with those of semilunar ganglion RF thermocoagulation (GRF) under local anesthesia, for exploring a new and available surgical method for patients with V2 + V3 idiopathic trigeminal neuralgia. PATIENTS AND METHODS 102 patients with V2 + V3 idiopathic trigeminal neuralgia were enrolled in this prospective randomized controlled clinical trial, and they were divided into the PRF and GRF group randomly (n = 51 in both groups). The outcome of pain relief was assessed using the Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed). Recurrence was defined as a relapse to a previous lower level after attainment of any higher level of pain relief. The immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications were observed and recorded. RESULTS Their basic conditions (age, gender ratio, side of pain, and disease duration) were similar. Furthermore, we found that the 2-year postoperative effective rate between them had no significant difference. By comparing the two groups, PRF group had the better immediate effective rate of the V2 branch and no severe complications such as corneal ulcer, however, GRF group had lower 2-year postoperative recurrence rate of the V3 branch and fewer facial swelling. CONCLUSION The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.",2020,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","['patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia', '102 patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia']","['PRF and GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation', 'semilunar ganglion RF thermocoagulation (GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO']","['facial swelling', 'pain relief', 'Recurrence', 'immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications', '2-year postoperative effective rate', 'immediate effective rate of the V2 branch and no severe complications such as corneal ulcer', 'Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed', '2-year postoperative recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}]","[{'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0017067', 'cui_str': 'Structure of nervous system ganglion'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}, {'cui': 'C0016521', 'cui_str': 'Structure of foramen ovale of heart'}, {'cui': 'C0040995', 'cui_str': 'Structure of trigeminal ganglion'}]","[{'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010043', 'cui_str': 'Corneal ulcer'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",102.0,0.0255936,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': ""Department of Pain Clinic, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Changxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Pain Clinic, Subei People's Hospital, Yangzhou, Jiangsu, 225002, People's Republic of China. Electronic address: 1714452550@qq.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China. Electronic address: zy830226@163.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106025'] 2917,32590385,Mechanical Ventilation Strategy Guided by Transpulmonary Pressure in Severe Acute Respiratory Distress Syndrome Treated With Venovenous Extracorporeal Membrane Oxygenation.,"OBJECTIVES Previous studies have suggested that adjusting ventilator settings based on transpulmonary pressure measurements may minimize ventilator-induced lung injury, but this has never been investigated in patients with severe acute respiratory distress syndrome supported with venovenous extracorporeal membrane oxygenation. We aimed to evaluate whether a transpulmonary pressure-guided ventilation strategy would increase the proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation support in patients with severe acute respiratory distress syndrome. DESIGN Single-center, prospective, randomized controlled trial. SETTING Sixteen-bed, respiratory ICU at a tertiary academic medical center. PATIENTS Severe acute respiratory distress syndrome patients receiving venovenous extracorporeal membrane oxygenation. INTERVENTIONS One-hundred four patients were randomized to transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group (n = 52) groups. Two patients had cardiac arrest during establishment of venovenous extracorporeal membrane oxygenation in the lung rest group did not receive the assigned intervention. Thus, 102 patients were included in the analysis. MEASUREMENTS AND MAIN RESULTS The proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation in the transpulmonary pressure-guided group was significantly higher than that in the lung rest group (71.2% vs 48.0%; p = 0.017). Compared with the lung rest group, driving pressure, tidal volumes, and mechanical power were significantly lower, and positive end-expiratory pressure was significantly higher, in the transpulmonary pressure-guided group during venovenous extracorporeal membrane oxygenation support. In the transpulmonary pressure-guided group, levels of interleukin-1β, interleukin-6, and interleukin-8 were significantly lower, and interleukin-10 was significantly higher, than those of the lung rest group over time. Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group. CONCLUSIONS A transpulmonary pressure-guided ventilation strategy could increase the proportion of patients with severe acute respiratory distress syndrome successfully weaned from venovenous extracorporeal membrane oxygenation.",2020,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group. ","['102 patients were included in the analysis', 'Severe Acute Respiratory Distress Syndrome Treated With', 'Severe acute respiratory distress syndrome patients receiving', 'Sixteen-bed, respiratory ICU at a tertiary academic medical center', 'patients with severe acute respiratory distress syndrome', 'One-hundred four patients']","['transpulmonary pressure-guided ventilation strategy', 'venovenous extracorporeal membrane oxygenation', 'Mechanical Ventilation Strategy Guided by Transpulmonary Pressure', 'transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group', 'Venovenous Extracorporeal Membrane Oxygenation', 'venovenous extracorporeal membrane oxygenation support']","['proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation', 'driving pressure, tidal volumes, and mechanical power', 'cardiac arrest', 'Lung density', 'positive end-expiratory pressure', 'levels of interleukin-1β, interleukin-6, and interleukin-8']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",104.0,0.101497,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group. ","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'All authors: Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Xuyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Hangyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Haichao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004445'] 2918,32590411,An Isolated Transosseous Flexible Suture Frame in the Treatment of Patellar Tendon Rupture Provides Adequate Mechanical Resistance.,"INTRODUCTION Acute patellar tendon ruptures are frequently observed in patients with metabolic comorbidities, and the benchmark treatment is surgical repair. It is desirable not to harm an already fragile biologic environment with sutures and hardware. We aimed to compare the mechanical requirements of an isolated, flexible, high-strength nonabsorbable transosseous suture frame with that of the Krackow suture technique. METHODS A total of 12 cadaveric pieces were randomized into two groups: the isolated flexible frame group (n = 6) and the standard Krackow fixation group (n = 6). A traumatic rupture of the patellar tendon was performed, and a transosseous displacement sensor was installed on a validated biomechanical system. Gap formation was measured during 50 cycles of flexion and extension with traction on the quadriceps (250 N). Subsequently, specimens underwent progressive loading in a fixed flexion position until failure occurred. The data were analyzed using nonparametric statistical tools with a significance level of 5%. RESULTS The isolated frame group had a smaller gap formation (1.7 mm) than the Krackow group (3.4 mm; P = 0.01). No significant difference existed in the median failure end points of the two groups (676 and 530 N, respectively; P = 0.11). DISCUSSION Patellar tendon repair using an isolated, transosseous, flexible, suture frame outperformed using the traditional Krakow repair technique in gap formation. Further studies are needed to determine if this will result in better functional outcomes or fewer clinical failures. LEVEL OF EVIDENCE Level IV, experimental case series.",2020,The isolated frame group had a smaller gap formation (1.7 mm) than the Krackow group (3.4 mm; P = 0.01).,"['patients with metabolic comorbidities', '12 cadaveric pieces']","['Krackow suture technique', 'standard Krackow fixation']","['Gap formation', 'median failure end points', 'smaller gap formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",,0.0456217,The isolated frame group had a smaller gap formation (1.7 mm) than the Krackow group (3.4 mm; P = 0.01).,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Besa', 'Affiliation': 'From the Department of Orthopedic Surgery, Pontificia Universidad Católica de Chile (Dr. Besa, Dr. Irarrázaval, and Dr. M. Orrego), the School of Medicine, Universidad de Los Andes Santiago, Chile (Dr. F. Orrego and Dr. Cariola), the Department of Orthopedic Surgery, School of Medicine, Universidad de los Andes Santiago, Chile (Dr. Telias and Dr. Amenábar), and the Integrative Biomechanics and Physiology of Strain Laboratory (LIBFE), School of Kinesiology, Universidad de los Andes (Dr. Guzmán-Venegas and Mr. Palma), Santiago, Chile.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Telias', 'Affiliation': ''}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Orrego', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Guzmán-Venegas', 'Affiliation': ''}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Cariola', 'Affiliation': ''}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Amenábar', 'Affiliation': ''}, {'ForeName': 'Felipe H', 'Initials': 'FH', 'LastName': 'Palma', 'Affiliation': ''}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Irarrázaval', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Orrego', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-19-00509'] 2919,32590482,Comparative study of topical steroids vs nonsteroidal anti-inflammatory drugs to control post-cataract surgery inflammation.,"PURPOSE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% in comparison with topical steroids following phacoemulsification cataract surgery, while specifically looking at differences in visual acuities, anterior chamber reaction, and central retinal thickness changes. SETTING Mission Nethralaya, India. DESIGN Prospective, randomized, investigator-masked, comparative clinical trial. METHODS Patients were randomly assigned to 3 treatment groups: In Group I bromfenac was prescribed 3 times a day for 1 month; in Group II prednisolone acetate 1% eye suspension was prescribed 4 times a day for 1 month; and in Group III prednisolone acetate 1% was prescribed 4 times a day for 2 weeks and bromfenac 2 times a day for 1 month. All patients received anti-infective preoperative and postoperative standards of care. Study visit assessments included corrected distance visual acuity, biomicroscopy, intraocular pressure, adverse events, and concomitant medication review. Optical coherence tomography was performed on postoperative days 7, 21, and 60. RESULTS Each group included 150 eyes. All treatment groups had similar baseline measurements. There was a significant difference in anterior chamber reaction observed between Group I and Group II (P < 0.001) and Group I and Group III (P < 0.001) on postoperative days 1 and 7. On postoperative day 21, thickening of the central fovea was observed in Group II as compared with Group I and Group III. This difference was statistically significant (p<0.001). CONCLUSIONS The combination of topical NSAIDs and topical steroids resulted in positive clinical outcomes following cataract surgery.",2020,There was a significant difference in anterior chamber reaction observed between Group I and Group II (P < 0.001) and Group I and Group III (P < 0.001) on postoperative days 1 and 7.,"['cataract surgery', 'control post-cataract surgery inflammation', 'Patients', 'Mission Nethralaya, India']","['Optical coherence tomography', 'topical steroids', 'bromfenac ophthalmic solution', 'prednisolone acetate', 'topical NSAIDs and topical steroids', 'topical steroids vs nonsteroidal anti-inflammatory drugs', 'prednisolone acetate 1% eye suspension']","['corrected distance visual acuity, biomicroscopy, intraocular pressure, adverse events, and concomitant medication review', 'anterior chamber reaction', 'positive clinical outcomes', 'thickening of the central fovea', 'visual acuities, anterior chamber reaction, and central retinal thickness changes']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1618765', 'cui_str': 'bromfenac Ophthalmic Solution'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0991532', 'cui_str': 'Eye suspension'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",150.0,0.0427647,There was a significant difference in anterior chamber reaction observed between Group I and Group II (P < 0.001) and Group I and Group III (P < 0.001) on postoperative days 1 and 7.,"[{'ForeName': 'Amarendra', 'Initials': 'A', 'LastName': 'Deka', 'Affiliation': 'From Mission Nethralaya, Shillong, India.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000291'] 2920,32590519,Efficiency in DIEP Flap Breast Reconstruction: The Real Benefit of CTA Imaging.,"INTRODUCTION In DIEP flap breast reconstruction many surgeons use preoperative imaging for perforator mapping as a method to plan the operation, reduce operative times, and potentially limit morbidity. In this study we compare operative times for specific portions of DIEP flap harvest with and without preoperative CTA imaging. METHODS A prospective study of two patient groups undergoing DIEP flap breast reconstruction was performed. In the experimental group the harvesting surgeon was blinded to the preoperative CTA, whereas in the control group the harvesting surgeon assessed the CTA preoperatively. Comparison of times for initial perforator identification, perforator selection, flap harvest time, and total procedure times was performed. The choice of perforators was evaluated. Correlation of perforator choice preoperatively and intraoperatively was also performed. RESULTS Times were recorded in 60 DIEP flaps; 27 blinded and 33 unblinded. The non-blinded group was more efficient in all categories; time to first perforator identification (28.6 vs. 17.8 minutes, p<0.0001), time to perforator decision-making (23.1 vs. 5.6 minutes, p<0.0001), time to flap harvest (128 vs 80 min, p<0.0001), and total operative time (417 vs 353 min, p<0.001). Perforator location was not different among groups. Blinded intraoperative decisions correlated with preoperative imagine in 74% of flaps. More perforators were included in the blinded flaps compared to the non-blinded flaps (2.3 vs 1.4, p<0.001). CONCLUSION Use of preoperative CTA leads to decreased operative times, specifically with regards to perforator identification and perforator selection. Without the use of preoperative CTA, surgeons included more perforators in the flaps.",2020,"The non-blinded group was more efficient in all categories; time to first perforator identification (28.6 vs. 17.8 minutes, p<0.0001), time to perforator decision-making (23.1 vs. 5.6 minutes, p<0.0001), time to flap harvest (128 vs 80 min, p<0.0001), and total operative time (417 vs 353 min, p<0.001).","['DIEP Flap Breast Reconstruction', 'two patient groups undergoing']","['DIEP flap harvest with and without preoperative CTA imaging', 'DIEP flap breast reconstruction']","['initial perforator identification, perforator selection, flap harvest time, and total procedure times', 'total operative time', 'time to flap harvest', 'operative times', 'time to perforator decision-making']","[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",,0.0361083,"The non-blinded group was more efficient in all categories; time to first perforator identification (28.6 vs. 17.8 minutes, p<0.0001), time to perforator decision-making (23.1 vs. 5.6 minutes, p<0.0001), time to flap harvest (128 vs 80 min, p<0.0001), and total operative time (417 vs 353 min, p<0.001).","[{'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Haddock', 'Affiliation': ''}, {'ForeName': 'Danielle O', 'Initials': 'DO', 'LastName': 'Dumestre', 'Affiliation': ''}, {'ForeName': 'Sumeet S', 'Initials': 'SS', 'LastName': 'Teotia', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007148'] 2921,32583712,Use of traction table did not increase complications in total hip arthroplasty through direct anterior approach performed by novice surgeon.,"PURPOSE The purpose of this study was to investigate the surgical outcomes of total hip arthroplasty (THA) through direct anterior approach (DAA) performed by beginners by comparing the outcomes after the introduction of DAA-THA between using a normal operating table and a traction table. METHODS The total subjects were 200 patients, there were 120 cases from the introduction of three surgeons using a normal table and 80 cases from two surgeons using a traction table. The surgical procedure was standardized, and a surgeon skilled in DAA entered the operating room and instructed the novice surgeons of DAA in all cases. RESULTS The mean operative time was no significant difference between the two groups ( p = 0.093). The difference in slope of the operative time was no significant difference between the two groups ( p value = 0.089). The mean fluoroscopy time and the mean blood loss were significant difference between the two groups ( p < 0.05). The difference in slope of the fluoroscopy time and blood loss were significant difference between the two groups ( p < 0.05). There were no intraoperative complications and no reoperations for any reason. CONCLUSIONS At the facility with a surgeon skilled in DAA, the use of a traction table in DAA did not increase the complication rate compared with the use of a normal operating table when the exclusion criteria for DAA were set and surgery was performed using intraoperative fluoroscopy under supervision by a skilled surgeon.",2020,The mean fluoroscopy time and the mean blood loss were significant difference between the two groups ( p < 0.05).,"['total subjects were 200 patients, there were 120 cases from the introduction of three surgeons using a normal table and 80 cases from two surgeons using a traction table']","['traction table', 'total hip arthroplasty (THA) through direct anterior approach (DAA']","['intraoperative complications', 'slope of the operative time', 'mean operative time', 'complication rate', 'slope of the fluoroscopy time and blood loss', 'mean fluoroscopy time and the mean blood loss']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0183817', 'cui_str': 'Traction table'}]","[{'cui': 'C0183817', 'cui_str': 'Traction table'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",200.0,0.0249639,The mean fluoroscopy time and the mean blood loss were significant difference between the two groups ( p < 0.05).,"[{'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Banno', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tanabe', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Homma', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ochi', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Watari', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020923093'] 2922,32580300,Changes in the Bristle Stiffness of Polybutylene Terephthalate Manual Toothbrushes over 3 Months: A Randomized Controlled Trial.,"We previously reported that polybutylene terephthalate (PBT) toothbrushes become less effective for plaque removal after two months of use. However, it remains unknown how the bristle stiffness of PBT toothbrushes changes after several months of use. We performed a single-center randomized controlled trial to evaluate the bristle stiffness and bristle splaying of soft and medium manual toothbrushes among dental and medical students of Hiroshima University. Subjects were 80 participants who met the criteria. Participants were randomly assigned to the soft toothbrush group (n = 40) or the medium toothbrush group (n = 40). We collected toothbrushes immediately after first use (T0), after one month of use (T1), after two months of use (T2), and after three months of use (T3). Bristle stiffness was measured according to the International Organization for Standardization (ISO) 22254. The mean bristle stiffness (N/cm 2 ) of soft and medium toothbrushes was significantly lower at T2 and T3 than at T0 (T2 vs. T0, soft; 3.63 vs. 3.89, P < 0.01 and medium; 4.33 vs. 4.52, P < 0.05, respectively, and T3 vs. T0, 3.62 vs. 3.89, p < 0.01 and 4.18 vs. 4.52, p < 0.001, respectively). Bristle stiffness was significantly reduced in soft and medium PBT toothbrushes after two months of use.",2020,"The mean bristle stiffness (N/cm 2 ) of soft and medium toothbrushes was significantly lower at T2 and T3 than at T0 (T2 vs. T0, soft; 3.63 vs. 3.89, P < 0.01 and medium;","['Subjects were 80 participants who met the criteria', 'dental and medical students of Hiroshima University']","['soft and medium manual toothbrushes', 'polybutylene terephthalate (PBT) toothbrushes', 'medium toothbrush group']","['mean bristle stiffness', 'Bristle stiffness']","[{'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}, {'cui': 'C0071364', 'cui_str': 'poly(1,4-butylene terephthalate)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",80.0,0.0593318,"The mean bristle stiffness (N/cm 2 ) of soft and medium toothbrushes was significantly lower at T2 and T3 than at T0 (T2 vs. T0, soft; 3.63 vs. 3.89, P < 0.01 and medium;","[{'ForeName': 'Yoshino', 'Initials': 'Y', 'LastName': 'Kaneyasu', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Shigeishi', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Ohta', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}]","Materials (Basel, Switzerland)",['10.3390/ma13122802'] 2923,32580399,"A Randomized Trial of Deep Brain Stimulation to the Subcallosal Cingulate and Nucleus Accumbens in Patients with Treatment-Refractory, Chronic, and Severe Anorexia Nervosa: Initial Results at 6 Months of Follow Up.","BACKGROUND The main objective of this study was to assess the safety and efficacy of deep brain stimulation (DBS) in patients with severe anorexia nervosa (AN). METHODS Eight participants received active DBS to the subcallosal cingulate (SCC) or nucleus accumbens (NAcc) depending on comorbidities (affective or anxiety disorders, respectively) and type of AN. The primary outcome measure was body mass index (BMI). RESULTS Overall, we found no significant difference ( p = 0.84) between mean preoperative and postoperative (month 6) BMI. A BMI reference value (BMI-RV) was calculated. In patients that received preoperative inpatient care to raise the BMI, the BMI-RV was defined as the mean BMI value in the 12 months prior to surgery. In patients that did not require inpatient care, the BMI-RV was defined as the mean BMI in the 3-month period before surgery. This value was compared to the postoperative BMI (month 6), revealing a significant increase ( p = 0.02). After 6 months of DBS, five participants showed an increase of ≥10% in the BMI-RV. Quality of life was improved ( p = 0.03). Three cases presented cutaneous complications. CONCLUSION DBS may be effective for some patients with severe AN. Cutaneous complications were observed. Longer term data are needed.",2020,"Overall, we found no significant difference ( p = 0.84) between mean preoperative and postoperative (month 6) BMI.","['Patients with Treatment-Refractory, Chronic, and Severe Anorexia Nervosa', 'patients with severe anorexia nervosa (AN', 'Eight participants received', 'patients with severe AN']","['deep brain stimulation (DBS', 'active DBS to the subcallosal cingulate (SCC) or nucleus accumbens (NAcc', 'DBS', 'Deep Brain Stimulation']","['postoperative BMI', 'BMI-RV', 'safety and efficacy', 'mean BMI', 'Quality of life', 'Cutaneous complications', 'A BMI reference value (BMI-RV', 'mean BMI value', 'body mass index (BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0312145,"Overall, we found no significant difference ( p = 0.84) between mean preoperative and postoperative (month 6) BMI.","[{'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Villalba Martínez', 'Affiliation': 'Department of Neurosurgery, Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Justicia', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain.'}, {'ForeName': 'Purificación', 'Initials': 'P', 'LastName': 'Salgado', 'Affiliation': 'Institut de Neuropsiquiatria i Adiccions (INAD), Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Ginés', 'Affiliation': 'Institut de Neuropsiquiatria i Adiccions (INAD), Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Guardiola', 'Affiliation': 'Institut de Neuropsiquiatria i Adiccions (INAD), Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cedrón', 'Affiliation': 'Institut de Neuropsiquiatria i Adiccions (INAD), Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Polo', 'Affiliation': 'Institut de Neuropsiquiatria i Adiccions (INAD), Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Delgado-Martínez', 'Affiliation': 'Department of Neurosurgery, Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Medrano', 'Affiliation': 'Department of Radiology, Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Manero', 'Affiliation': 'Department of Neurology, Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Conesa', 'Affiliation': 'Department of Neurosurgery, Hospital del Mar, 08003 Barcelona, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Faus', 'Affiliation': 'ITA, Mental Health Specialists, 08036 Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Grau', 'Affiliation': 'ITA, Mental Health Specialists, 08036 Barcelona, Spain.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Elices', 'Affiliation': 'Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Pérez', 'Affiliation': 'Department of Psychiatry and Forensic Medicine, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, 08193 Barcelona, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9061946'] 2924,32580451,The Effect of an Online Sugar Fact Intervention: Change of Mothers with Young Children.,"Research indicates that high sugar intake in early childhood may increase risks of tooth decay, obesity and chronic disease later in life. In this sugar fact study, we explored whether an online intervention which focused on comprehensive and useful information about nutrition labels impacted mother's choice of low sugar food. The intervention was developed on the basis of the theory of planned behavior. In total, 122 mothers were recruited. Mothers were divided into an online-only group and a plus group. Knowledge of sugar and nutrition labels, behavioral attitudes, perceived behavioral control, behavioral intentions and behavior towards purchasing low-sugar products with nutrition labels were collected. After the intervention, both groups exhibited significantly enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior. Compared to the online-only group, knowledge, perceived behavioral control and behavior of the plus group significantly improved. After the intervention, about 40% of the plus group and 80% of the online-only group still did not know the World Health Organization (WHO) sugar recommendations. Understanding sugar recommendations and using nutrition labels are crucial to help people control calorie and sugar intake. Further research with a larger sample is warranted to evaluate the effects of the intervention on long-term changes in shopping behavior. More efficient and convenient nutrition education is required to increase public awareness of sugar recommendations and help people control calorie and sugar intake.",2020,"After the intervention, both groups exhibited significantly enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior.","['Mothers with Young Children', '122 mothers were recruited']","['online-only group still did not know the World Health Organization (WHO) sugar recommendations', 'Online Sugar Fact Intervention']","['knowledge, perceived behavioral control and behavior', 'enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1880386', 'cui_str': ""Don't know""}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",122.0,0.0263722,"After the intervention, both groups exhibited significantly enhanced sugar and nutrition label knowledge, perceived behavioral control, behavioral intentions and behavior.","[{'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Huang', 'Affiliation': 'Research Center of Health Equity, College of Public Health, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chien', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}, {'ForeName': 'Mei Chun', 'Initials': 'MC', 'LastName': 'Chen', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, Xinyi District, Taipei City 110, Taiwan.'}]",Nutrients,['10.3390/nu12061859'] 2925,32580480,Effectiveness of the Muscle Energy Technique versus Osteopathic Manipulation in the Treatment of Sacroiliac Joint Dysfunction in Athletes.,"BACKGROUND The study of injuries stemming from sacroiliac dysfunction in athletes has been discussed in many papers. However, the treatment of this issue through thrust and muscle-energy techniques has hardly been researched. The objective of our research is to compare the effectiveness of thrust technique to that of energy muscle techniques in the resolution of sacroiliac joint blockage or dysfunction in middle-distance running athletes. METHODS A quasi-experimental design with three measures in time (pre-intervention, intervention 1, final intervention after one month from the first intervention) was made. The sample consisted of 60 adult athletes from an Athletic club, who were dealing with sacroiliac joint dysfunction. The sample was randomly divided into three groups of 20 participants (43 men and 17 women). One intervention group was treated with the thrust technique, another intervention group was treated with the muscle-energy technique, and the control group received treatment by means of a simulated technique. A prior assessment of the range of motion was performed by means of a seated forward flexion test, a standing forward flexion test, and the Gillet test. After observing the dysfunction, the corresponding technique was performed on each intervention group. The control group underwent a simulated technique. A second intervention took place a month later, in order to ascertain possible increased effectiveness. RESULTS Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention). Comparing the changes in time, only the thrust group obtained statistically significant differences ( p = 0.000, with a reduction of positive dysfunction, starting at 20 positives, five positive in the initial intervention and two positive in the final intervention) and when comparing both techniques, it was observed that between the first intervention and the final intervention, the thrust technique was significantly higher than the MET technique ( p = 0.032). CONCLUSIONS The thrust manipulation technique is more effective in the treatment of sacroiliac dysfunction than the energy muscle technique, in both cases obtaining satisfactory results with far middle-distance running athletes. Finally, the thrust technique showed positive results in the first intervention and also in the long term, in contrast to the MET technique that only obtained changes after the first intervention.",2020,"Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention).","['Sacroiliac Joint Dysfunction in Athletes', '60 adult athletes from an Athletic club, who were dealing with sacroiliac joint dysfunction', '20 participants (43 men and 17 women', 'middle-distance running athletes']","['simulated technique', 'Muscle Energy Technique versus Osteopathic Manipulation', 'placebo']",['positive dysfunction'],"[{'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",60.0,0.0131154,"Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention).","[{'ForeName': 'Urko José', 'Initials': 'UJ', 'LastName': 'García-Peñalver', 'Affiliation': 'Facultad de Fisioterapia, Universidad Católica de San Antonio (UCAM), Av. de los Jerónimos, 135, 30107 Murcia, Spain.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Palop-Montoro', 'Affiliation': 'Facultad de Fisioterapia, Universidad Católica de San Antonio (UCAM), Av. de los Jerónimos, 135, 30107 Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Manzano-Sánchez', 'Affiliation': 'Facultad de Ciencias del Deporte, Universidad de Murcia, Calle Argentina, 19, 30720 San Javier, Murcia Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124490'] 2926,31805025,Effectiveness of Tailored Rehabilitation Education in Improving the Health Literacy and Health Status of Postoperative Patients With Breast Cancer: A Randomized Controlled Trial.,"BACKGROUND The improvement of breast cancer treatment and the extension of survivorship have led to the development of postoperative complications among cancer survivors. Health literacy (HL), defined as patients' capability of using health information to maintain their health status, can enable breast cancer patients to manage postoperative complications. OBJECTIVE The aims of this study were to develop a tailored rehabilitation education (TRE) program and examine the effectiveness of this program in improving the HL and health status with breast cancer. METHODS This randomized controlled trial recruited 99 breast cancer patients (49 and 50 in the intervention and control groups, respectively) within 1 week after surgery. Four-week individualized TRE programs were implemented to improve their HL and health status. RESULTS Our results showed that the TRE program produced significant improvements in HL and health status in the components of the International Classification of Functioning, Disability and Health. However, no significant difference was observed in the activity scores obtained using the Barthel Index between the 2 groups. CONCLUSION Our finding supports the effectiveness of 1-month TRE in improving HL and all components of the International Classification of Functioning, Disability and Health status, except the activity component among breast cancer in Taiwan. IMPLICATIONS FOR PRACTICE Clinicians could incorporate the TRE techniques in the rehabilitation sessions according to the healthcare, disease prevention, and health promotion domains to improve the clinical outcomes as well as change their health behaviors and attitudes of patients with breast cancer.",2020,"However, no significant difference was observed in the activity scores obtained using the Barthel Index between the 2 groups. ","['Postoperative Patients With Breast Cancer', '99 breast cancer patients (49 and 50 in the intervention and control groups, respectively) within 1 week after surgery', 'breast cancer in Taiwan', 'patients with breast cancer']","['Tailored Rehabilitation Education', 'TRE', 'tailored rehabilitation education (TRE) program', 'TRE program']","['HL and health status', 'activity scores', 'Health Literacy and Health Status']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.0172838,"However, no significant difference was observed in the activity scores obtained using the Barthel Index between the 2 groups. ","[{'ForeName': 'Szu-Chi', 'Initials': 'SC', 'LastName': 'Huang', 'Affiliation': 'Author Affiliations: Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital (Ms Huang and Drs CY Lin and Hou); School of Nursing, College of Nursing, Taipei Medical University (Drs Kuo, Tsai, and PC Lin); Department of Physical Medicine and Rehabilitation, E-Da Cancer Hospital/I-Shou University, Kaohsiung (Ms Tsai); Department of Physical Medicine and Rehabilitation, E-Da Hospital/I-Shou University, Kaohsiung (Mr Chen); Department of Nursing, Wang Fang Hospital, Taipei Medical University (Dr Tsai); Master Program in Long-term Care, College of Nursing, Taipei Medical University (Ms Huang and Drs PC Lin and Hou); School of Gerontology Health Management, College of Nursing, Taipei Medical University (Dr Hou); and Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taiwan (Dr Hou).'}, {'ForeName': 'Shu-Fen', 'Initials': 'SF', 'LastName': 'Kuo', 'Affiliation': ''}, {'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Chia-Yin', 'Initials': 'CY', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Sheng-Shiung', 'Initials': 'SS', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Chia-Yun', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Pi-Chu', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Wen-Hsuan', 'Initials': 'WH', 'LastName': 'Hou', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000665'] 2927,31807731,A Culturally Adapted Diabetes Prevention Intervention in the New York City Sikh Asian Indian Community Leads to Improvements in Health Behaviors and Outcomes.,"Introduction Sikh Asian Indians are an underserved, minority group demonstrating high rates of diabetes. Community health workers (CHWs) are effective in addressing health disparities by reaching socially and linguistically isolated populations. There are no culturally-adapted programs for diabetes prevention among Sikh Asian Indians, thus, this study tests the efficacy of a culturally-tailored CHW intervention to improve diabetes prevention-related outcomes among Sikh Asian Indians at-risk for diabetes. Methods A quasi-experimental two-arm intervention among Sikh Asian Indian adults at-risk for diabetes and living in New York City (n=160) was conducted in 2013-2014. The treatment group received six monthly CHW group education sessions and ten follow-up phone calls; the control group received the first session. Main outcomes included weight, body mass index (BMI), blood pressure (BP), physical activity (PA), diet, and health self-efficacy. Results Positive and significant changes in weight, BMI, and diabetes prevention-related indicators were seen among both study groups. However, only treatment group participants showed significant changes over time for weight, BMI, PA self-efficacy, and health-related self-efficacy. Significant between-group differences were seen in adjusted analyses for weight, BMI, systolic BP, total weekly PA, PA self-efficacy, PA social interaction, portion control, barriers to healthy eating, and health self-efficacy. At 6-months, treatment participants were more likely to lose ≥5% and ≥7% of their weight compared to control participants (p=0.071, and p=0.015, respectively). Conclusions Findings demonstrate that a culturally-adapted CHW diabetes prevention program in the Sikh community is efficacious, adding to the growing literature on CHWs' capacity to address health inequity among underserved populations.",2019,"However, only treatment group participants showed significant changes over time for weight, BMI, PA self-efficacy, and health-related self-efficacy.","['Sikh Asian Indian adults at-risk for diabetes and living in New York City (n=160) was conducted in 2013-2014', 'Community health workers (CHWs']","['Methods\n\n\nA quasi-experimental two-arm intervention', 'Culturally Adapted Diabetes Prevention Intervention', 'six monthly CHW group education sessions', 'culturally-tailored CHW intervention']","['weight, body mass index (BMI), blood pressure (BP), physical activity (PA), diet, and health self-efficacy', 'weight, BMI, and diabetes prevention-related indicators', 'time for weight, BMI, PA self-efficacy, and health-related self-efficacy', 'weight, BMI, systolic BP, total weekly PA, PA self-efficacy, PA social interaction, portion control, barriers to healthy eating, and health self-efficacy']","[{'cui': 'C0337696', 'cui_str': 'Sikhism'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]",,0.00958234,"However, only treatment group participants showed significant changes over time for weight, BMI, PA self-efficacy, and health-related self-efficacy.","[{'ForeName': 'Sahnah', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'NYU School of Medicine.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Wyatt', 'Affiliation': 'NYU School of Medicine.'}, {'ForeName': 'Harmanpreet', 'Initials': 'H', 'LastName': 'Chauhan', 'Affiliation': 'California State University Fullerton.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Zanowiak', 'Affiliation': 'NYU School of Medicine.'}, {'ForeName': 'Rucha', 'Initials': 'R', 'LastName': 'Kavathe', 'Affiliation': 'UNITED SIKHS.'}, {'ForeName': 'Hardayal', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'UNITED SIKHS.'}, {'ForeName': 'Simona C', 'Initials': 'SC', 'LastName': 'Kwon', 'Affiliation': 'NYU School of Medicine.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Trin-Shevrin', 'Affiliation': 'NYU School of Medicine.'}, {'ForeName': 'Nadia S', 'Initials': 'NS', 'LastName': 'Islam', 'Affiliation': 'NYU School of Medicine.'}]",Health behavior research,['10.4148/2572-1836.1027'] 2928,31810753,Efficacy of the presence of an emergency physician in prehospital major trauma care: Randomised control trial results are needed!,,2020,,['prehospital major trauma care'],['emergency physician'],[],"[{'cui': 'C0332677', 'cui_str': 'Major injury'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",[],,0.0446977,,"[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Jouffroy', 'Affiliation': ""SAMU de Paris, Service d'Anesthésie Réanimation, Hôpital Universitaire Necker - Enfants Malades, Assistance Publique - Hôpitaux de Paris, and Université Paris Descartes - Paris 5, Paris, France. Electronic address: romain.jouffroy@aphp.fr.""}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Vivien', 'Affiliation': ""SAMU de Paris, Service d'Anesthésie Réanimation, Hôpital Universitaire Necker - Enfants Malades, Assistance Publique - Hôpitaux de Paris, and Université Paris Descartes - Paris 5, Paris, France.""}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.033'] 2929,31820116,"Automated Reminders Improve Retinal Screening Rates in Low Income, Minority Patients with Diabetes and Correct the African American Disparity.","Diabetic retinopathy (DR) is a major cause of blindness in the United States. Prevention relies on periodic DR screening, yet overall national screening rates are not optimal, especially in low-income, minority patients. We prospectively evaluated show rates for prescheduled teleretinal DR screening appointments in diabetic patients (n = 301) in a large safety-net clinic in South Central Los Angeles. Patients were predominately African American (n = 88) and Latino (n = 200). Patients received either usual care telephone reminders or automated reminder calls in addition to usual care. The overall mean (SEM) show rate for DR screening, irrespective of reminder method, was low: 54 + 1.03%. Show rates with usual care alone were 46.3 + 2.6%, and with automated reminders added, 59.9 + 1.47% (p = 0.036). Show rate with usual care amongst African Americans was 23.6 + 6.46% compared with 53.2 + 3.41% for Latinos (p = 0.025). When automated calling was added, the show rate doubled amongst African Americans, to 51.6 + 3.96% (p = 0.002) with a slightly higher, non-significant show rate in Latinos. In summary, show rates for pre-scheduled teleretinal DR screening appointments were low with usual care alone in a safety-net clinic, with evidence for a racial disparity amongst low-income, minority patients with diabetes. Addition of a pre-recorded automated reminder call improved show rates, and corrected much of the racial disparity observed. Greater focus on failed appointments as an explanation for low DR screening rates and racial disparities, and as a potentially remediable target with automated reminders, may improve DR screening rates and reduce blindness in low-income minority patients with diabetes.",2019,"When automated calling was added, the show rate doubled amongst African Americans, to 51.6 + 3.96% (p = 0.002) with a slightly higher, non-significant show rate in Latinos.","['Diabetic retinopathy (DR', 'diabetic patients (n\u2009=\u2009301) in a large safety-net clinic in South Central Los Angeles', 'low-income minority patients with diabetes', 'minority patients with diabetes', 'Patients were predominately African American (n\u2009=\u200988) and Latino (n\u2009=\u2009200']","['usual care telephone reminders or automated reminder calls in addition to usual care', 'teleretinal DR screening appointments']",[],"[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C3661444', 'cui_str': 'Safety-net Clinics'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1277181', 'cui_str': 'Diabetic retinopathy screening'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],,0.0392364,"When automated calling was added, the show rate doubled amongst African Americans, to 51.6 + 3.96% (p = 0.002) with a slightly higher, non-significant show rate in Latinos.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mehranbod', 'Affiliation': 'Harbor-UCLA Medical Center and Lundquist Research Institute, 1124 West Carson St, Torrance, CA, 90502, USA.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Genter', 'Affiliation': 'Harbor-UCLA Medical Center and Lundquist Research Institute, 1124 West Carson St, Torrance, CA, 90502, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Serpas', 'Affiliation': 'Harbor-UCLA Medical Center and Lundquist Research Institute, 1124 West Carson St, Torrance, CA, 90502, USA.'}, {'ForeName': 'Johana', 'Initials': 'J', 'LastName': 'Macias', 'Affiliation': 'Harbor-UCLA Medical Center and Lundquist Research Institute, 1124 West Carson St, Torrance, CA, 90502, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Campa', 'Affiliation': 'Los Angeles County Department of Health Services, Los Angeles, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bermon', 'Affiliation': 'Los Angeles County Department of Health Services, Los Angeles, CA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Ipp', 'Affiliation': 'Harbor-UCLA Medical Center and Lundquist Research Institute, 1124 West Carson St, Torrance, CA, 90502, USA. ipp@labiomed.org.'}]",Journal of medical systems,['10.1007/s10916-019-1510-3'] 2930,31843232,Effect of Serum Albumin Levels in Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial).,"Little data are available regarding the determinants and prognostic significance of serum albumin in Heart Failure with Preserved Ejection Fraction (HFpEF). We sought to examine the phenotypic correlates of albumin and its independent prognostic implications in HFpEF. We analyzed data from 3,254 subjects enrolled the TOPCAT trial. We stratified subjects according to tertiles of albumin and examined differences in various phenotypic traits between these strata, including 8 protein biomarkers selected ad hoc and measured from frozen samples available in a subset of participants (n = 372). We also assessed the relationship between albumin and the trial primary endpoint. Lower albumin was associated with older age, black race, and greater prevalence of NYHA class III-IV, peripheral arterial disease, atrial fibrillation and diabetes mellitus. Lower albumin was also associated with increased levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension. Albumin was a strong predictor of the primary trial endpoint, even after adjustment for the MAGGIC risk score (hazard ratio [HR] 0.72, confidence interval [CI] 0.67 to 0.78; p <0.0001) and prespecified traditional risk factors (HR 0.78, CI 0.71 to 0.85; p <0.0001). Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease. Albumin is a powerful risk predictor independent of traditional risk prediction models, even within normal ranges.",2020,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","['3,254 subjects enrolled the TOPCAT trial', 'Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial']",[],"['levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension', 'Serum Albumin Levels']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",3254.0,0.0639009,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","[{'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Prenner', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cvijic', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spires', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Zhuyin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Yarde', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Bhattacharya', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Zamani', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Mazurek', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Seiffert', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Gordon', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: julio.chirinos@uphs.upenn.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.006'] 2931,32585209,"Interactive, Proof of Concept Clinical Trial Design in Hidradenitis Suppurativa (HS).",,2020,,['Hidradenitis Suppurativa (HS'],[],[],"[{'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}]",[],[],,0.116806,,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: alice.gottlieb@mountsinai.org.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.06.006'] 2932,32585223,Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: A randomized trial.,"BACKGROUND Loop electrosurgical excision procedure (LEEP) may be performed under local anesthesia (LA) or general anesthesia (GA) and practice patterns differ worldwide. No randomized head-to-head comparison has been published to confirm or refute either practice. OBJECTIVE To compare LEEP under LA versus GA regarding patient satisfaction and procedure-related outcomes such as rates of involved margins, complications, pain, and blood loss. METHODS Consecutive women referred to our colposcopy unit were recruited. LEEP was performed under LA with four intracervical injections of bupivacaine hydrochloride 0.5% or under GA with fentanyl, propofol, and a laryngeal mask with sevoflurane maintenance. The primary endpoint was patient satisfaction assessed on the day of surgery and 14 days thereafter using a Likert scale (score 0-100) and a questionnaire. Secondary endpoints included rates of involved margins, procedure-related complications, pain, blood loss, and surgeon preference. Results were compared using nonparametric and chi-square tests. RESULTS Between July 2018 and February 2020, we randomized 208 women, 108 in the LA arm and 100 in the GA arm. In the intention-to-treat analysis, patient satisfaction did not differ between the study groups directly after surgery (Likert scale 100 [90-100] vs. 100 [90-100]; P=n.s.) and 14 days thereafter (Likert scale 100 [80-100] vs. 100 [90-100]; P=n.s.). In the per-protocol analysis, women in the LA arm had significantly smaller cone volumes (1.11 [0.70-1.83] vs. 1.58 [1.08-2.69] cm 3 , respectively; P<.001), less intraoperative blood loss (ΔHb; 0.2 [-0.1-0.4] vs. 0.5 [0.2-0.9]; P<.001), and higher satisfaction after 14 days (100 [90-100] vs. 100 [80-100]; P=.026), whereas surgeon preference favored GA (90 [79-100] vs. 100 [90-100], respectively; P=.001). All other secondary outcomes did not differ between groups (resection margin status R1: 6.6% vs. 2.1%, P=.26; cone fragmentation: 12.1% vs. 6.3%, P=.27; procedure duration: 151.5 [120-219.5] vs. 180 [117-241.5] seconds, P=.34; time to complete hemostasis: 60 [34-97] vs. 70 [48.25-122.25] seconds, P=.08; complication rate: 3.3% vs. 1.1%, P=.59). In a multivariate analysis, parity (P=.03), type of transformation zone (P=.03), and cone volume (P=.02), but not study group assignment, age, body mass index, and degree of dysplasia independently influenced the primary endpoint. CONCLUSION LEEP under LA is equally well tolerated and offers patient-reported as well as procedure-related benefits over GA, supporting the preferred practice in some institutions and refuting the preferred practice in others.",2020,"LEEP under LA is equally well tolerated and offers patient-reported as well as procedure-related benefits over GA, supporting the preferred practice in some institutions and refuting the preferred practice in others.","['Consecutive women referred to our colposcopy unit were recruited', '208 women, 108 in the LA arm and 100 in the GA arm', 'Between July 2018 and February 2020']","['LEEP under LA versus GA', 'electrosurgical excision procedure (LEEP', 'electrosurgical excision procedure under local or general anesthesia', 'LEEP', 'bupivacaine hydrochloride 0.5% or under GA with fentanyl, propofol', 'LEEP under LA']","['time to complete hemostasis', 'patient satisfaction assessed on the day of surgery and 14 days thereafter using a Likert scale', 'intraoperative blood loss', 'smaller cone volumes', 'rates of involved margins, procedure-related complications, pain, blood loss, and surgeon preference', 'rates of involved margins, complications, pain, and blood loss', 'higher satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",208.0,0.325585,"LEEP under LA is equally well tolerated and offers patient-reported as well as procedure-related benefits over GA, supporting the preferred practice in some institutions and refuting the preferred practice in others.","[{'ForeName': 'Günther A', 'Initials': 'GA', 'LastName': 'Rezniczek', 'Affiliation': 'Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany. Electronic address: guenther.rezniczek@rub.de.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hecken', 'Affiliation': 'Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Rehman', 'Affiliation': 'Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Askin', 'Initials': 'A', 'LastName': 'Dogan', 'Affiliation': 'Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Clemens B', 'Initials': 'CB', 'LastName': 'Tempfer', 'Affiliation': 'Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hilal', 'Affiliation': 'Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.041'] 2933,32585226,The effect of intrapartum oxygen supplementation on Category II fetal monitoring.,"OBJECTIVE Maternal oxygen (O 2 ) administration for Category II electronic fetal monitoring (EFM) is a widely used intrauterine resuscitation technique, despite a paucity of evidence on its ability to improve EFM patterns. We investigated the effect of intrapartum O 2 administration on Category II EFM patterns. STUDY DESIGN This is a secondary analysis of a randomized trial conducted from 2016-2017, in which patients ≥ 37 weeks in active labor with Category II EFM were assigned to 10 L/min O 2 by facemask or room air (RA) until delivery. Trained obstetric research nurses blinded to allocation extracted EFM data. The primary outcome was a composite of high-risk Category II features including recurrent variable decelerations, recurrent late decelerations, prolonged decelerations, tachycardia or minimal variability 60 minutes after randomization to RA or O 2 . Secondary outcomes included individual components of the composite, resolution of recurrent decelerations within 60 minutes of randomization and total deceleration area. Outcomes were compared between RA and O 2 groups using univariable statistics. Time-to-event analysis was used to compare time to resolution of recurrent decelerations between groups. Paired analysis was used to compare pre- and post- randomization outcomes within each group. RESULTS All 114 randomized patients (57 RA, 57 O 2 ) were included in this analysis. There was no difference in resolution of recurrent decelerations within 60 minutes between O 2 and RA groups (75.4% vs 86.0%, p 0.15). RA and O 2 groups had similar rates of composite high risk Category II features including recurrent variables, recurrent lates, prolonged decelerations, tachycardia, and minimal variability 60 minutes after randomization. Time to resolution of recurrent decelerations and total deceleration area were similar between RA and O 2 groups. Among patients who received O 2 , there was no difference in EFM features pre- and post- randomization. Similar findings were observed in pre- and post- EFM features in RA patients. CONCLUSION Intrapartum maternal O 2 administration for Category II EFM did not resolve high risk Category II features or hasten the resolution of recurrent decelerations. These results suggest that O 2 administration has no impact on improving Category II EFM patterns.",2020,"There was no difference in resolution of recurrent decelerations within 60 minutes between O 2 and RA groups (75.4% vs 86.0%, p 0.15).","['2016-2017, in which patients ≥ 37 weeks in active labor with Category II EFM', 'RA patients', 'All 114 randomized patients (57 RA, 57 O 2 ) were included in this analysis']","['10 L/min O 2 by facemask or room air (RA) until delivery', 'Maternal oxygen (O 2 ) administration for Category II electronic fetal monitoring (EFM', 'intrapartum oxygen supplementation']","['resolution of recurrent decelerations', 'individual components of the composite, resolution of recurrent decelerations within 60 minutes of randomization and total deceleration area', 'Category II fetal monitoring', 'Time to resolution of recurrent decelerations and total deceleration area', 'rates of composite high risk Category II features including recurrent variables, recurrent lates, prolonged decelerations, tachycardia, and minimal variability 60 minutes', 'composite of high-risk Category II features including recurrent variable decelerations, recurrent late decelerations, prolonged decelerations, tachycardia or minimal variability 60 minutes after randomization to RA or O 2 ', 'EFM features']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}]","[{'cui': 'C2985322', 'cui_str': 'Recurrent fetal heart rate deceleration'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015945', 'cui_str': 'Foetal monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0457246', 'cui_str': 'Prolonged deceleration - finding'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C3805223', 'cui_str': 'Recurrent variable fetal heart rate deceleration'}, {'cui': 'C0429482', 'cui_str': 'Late fetal heart deceleration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}]",114.0,0.197232,"There was no difference in resolution of recurrent decelerations within 60 minutes between O 2 and RA groups (75.4% vs 86.0%, p 0.15).","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St Louis School of Medicine. Electronic address: nraghuraman@wustl.edu.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'López', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St Louis School of Medicine.'}, {'ForeName': 'Ebony B', 'Initials': 'EB', 'LastName': 'Carter', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St Louis School of Medicine.'}, {'ForeName': 'Molly J', 'Initials': 'MJ', 'LastName': 'Stout', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St Louis School of Medicine.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ""Department of Women's Health, University of Texas at Austin, Dell Medical School.""}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': ""Department of Women's Health, University of Texas at Austin, Dell Medical School.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.037'] 2934,32585261,Evaluation of various irrigation activation systems to eliminate bacteria from the root canal system: a randomized controlled single blinded trial.,"OBJECTIVE To evaluate the effect of NaOCl irrigant activation using passive ultrasonic activation, F-files, XP-endo Finisher files and or needle irrigation alone on the reduction of intracanal bacteria from root canals in teeth undergoing root canal treatment. METHODS Eighty patients with asymptomatic apical periodontitis were randomly divided into four groups. Access cavities were prepared and pre-treatment samples were taken (S1). Canals were then prepared and post-instrumentation samples (S2) taken. NaOCl was then activated with the various irrigant activation systems and post-irrigation samples (S3) taken. The samples were processed and colony forming units (CFUs) of bacteria were determined. The reduction in CFUs among the experimental groups were analysed using the Kruskal Wallis test and pairwise comparisons with the Mann-Whitney test. The Friedman test was used to compare the differences in the reduction of CFUs within the groups. RESULTS Overall, for all groups there was a significant reduction in the CFUs from S1 to S2 (P < 0.05) and from S2 to S3 (P < 0.05). Both XP-endo Finisher and passive ultrasonic activation techniques were associated with the greatest reduction in CFUs with no significant difference between them (P = 0.24). However, both were associated with significantly lower CFUs when compared to F-file activation and needle irrigation (P < 0.05). F-file activation reduced the CFUs significantly more compared to needle irrigation (P = 0.04). CONCLUSIONS XP-endo Finisher file activation and passive ultrasonic activation were equivalent in terms of reduction in CFUs. F-file activation did not reduce the CFUs to the same extent as the XP-endo Finisher file and ultrasonic activation but reduced the CFUs more than needle irrigation. CLINICAL SIGNIFICANCE The present study highlights the effect of new XP-endo Finisher file and passive ultrasonic activation in reducing the bacterial load from the root canal system which is important for the success of root canal treatment.",2020,Both XP-endo Finisher and passive ultrasonic activation techniques were associated with the greatest reduction in CFUs with no significant difference between them (P = 0.24).,"['teeth undergoing root canal treatment', 'Eighty patients with asymptomatic apical periodontitis']","['passive ultrasonic activation, F-files, XP-endo Finisher files and or needle irrigation alone', 'new XP-endo Finisher file and passive ultrasonic activation']",['reduction in CFUs'],"[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",80.0,0.0138556,Both XP-endo Finisher and passive ultrasonic activation techniques were associated with the greatest reduction in CFUs with no significant difference between them (P = 0.24).,"[{'ForeName': 'Nidambur Vasudev', 'Initials': 'NV', 'LastName': 'Ballal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India. Electronic address: drballal@yahoo.com.'}, {'ForeName': 'Poornika', 'Initials': 'P', 'LastName': 'Gandhi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Padmaja A', 'Initials': 'PA', 'LastName': 'Shenoy', 'Affiliation': 'Department of Microbiology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Paul M H', 'Initials': 'PMH', 'LastName': 'Dummer', 'Affiliation': 'School of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103412'] 2935,32585263,Restorations after selective caries removal: 5-year randomized trial.,"OBJECTIVE To compare the survival of restorations placed in deep carious lesions after selective caries removal to soft dentin (SCRSD) over a 5-year period. A secondary aim was to investigate whether the material (amalgam or resin composite) affected the survival of restorations. METHODS This study used data derived from a multicenter randomized controlled clinical trial (Clinical trials registration NCT00887952). Inclusion criteria were: patients with permanent molars presenting occlusal or proximal deep caries lesions (≥1/2 of the dentin thickness on radiographic examination), positive response to a cold test, absence of spontaneous pain, negative sensitivity to percussion, and absence of periapical lesions. The teeth were randomized into SCRSD and restoration in a single visit or stepwise excavation (SW). Each of these groups was divided according to the filling material: amalgam (AM) or resin composite (RC). Survival analyses were performed to estimate therapy success rates over 5 years (adjusted Weibull regression model). RESULTS 172 restorations were evaluated, 95 from SCRSD group and 77 from SW group, being 61 AMG and 111 RC. The 5-year survival analysis showed similar success rates for SW (76%) and SCRSD (79%) as well as for AM and RC (p > 0.05). CONCLUSION This study showed that, after a 5-year follow-up period, the presence of decayed tissue beneath restorations in deep caries lesions did not seem to affect restoration survival. Amalgam and resin composite restorations had similar survival rates, irrespective of the caries removal technique used - SCRSD or SW. CLINICAL SIGNIFICANCE Selective caries removal to soft dentin can be used in the management of deep caries to avoid pulp exposure and preserve tooth structure without affecting restoration longevity.",2020,"Amalgam and resin composite restorations had similar survival rates, irrespective of the caries removal technique used - SCRSD or SW. ","['Inclusion criteria were: patients with permanent molars presenting occlusal or proximal deep caries lesions (≥1/2 of the dentin thickness on radiographic examination), positive response to a cold test, absence of spontaneous pain, negative sensitivity to percussion, and absence of periapical lesions']","['filling material: amalgam (AM) or resin composite (RC', 'material (amalgam or resin composite']","['5-year survival', 'survival rates', 'restoration survival', 'SCRSD', 'survival of restorations']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0333523', 'cui_str': 'Deep caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}]","[{'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0440138', 'cui_str': 'Amalgam (silver) dental filling material'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",172.0,0.117992,"Amalgam and resin composite restorations had similar survival rates, irrespective of the caries removal technique used - SCRSD or SW. ","[{'ForeName': 'Juliana Jobim', 'Initials': 'JJ', 'LastName': 'Jardim', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Heliana Dantas', 'Initials': 'HD', 'LastName': 'Mestrinho', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Koppe', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lilian Marly', 'Initials': 'LM', 'LastName': 'de Paula', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Luana Severo', 'Initials': 'LS', 'LastName': 'Alves', 'Affiliation': 'Federal University of Santa Maria, Santa Maria, RS, Brazil. Electronic address: luanaseal@gmail.com.'}, {'ForeName': 'Paulo Márcio', 'Initials': 'PM', 'LastName': 'Yamaguti', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Júlio César Franco', 'Initials': 'JCF', 'LastName': 'Almeida', 'Affiliation': 'Brasilia University, Brasilia, DF, Brazil.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Maltz', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103416'] 2936,32585278,"Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild-to-moderate distal subungual onychomycosis: A randomized, multi-center, double-blind, vehicle-controlled phase 3 study.","BACKGROUND Onychomycosis is a recalcitrant fungal nail infection. Topical antifungal agents may be preferred over systemic agents due to lack of systemic adverse events. OBJECTIVE We investigated the efficacy and safety of topical terbinafine 10% solution (MOB-015) for the treatment of distal and lateral subungual onychomycosis (DSO). METHODS In a multi-center, double-blind, phase III, North American study subjects with mild to moderate DSO involving 20-60% of at least one great toenail were randomized to once daily application of MOB-015 or matching vehicle for 48 weeks. The primary and secondary efficacy variables were complete and mycological cure, respectively. Safety evaluations were performed. RESULTS At week 52, the mycological cure (negative culture and KOH) rate in the MOB-015 and vehicle groups were 69.9% and 27.7%, respectively (P< 0.001). Complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% subjects, respectively (P=0.0195). Subjects with at least one adverse event (AE) leading to discontinuation were 2.8% in the MOB-015 and 4.2% in the vehicle group. LIMITATIONS Follow-up period after end of treatment may not be sufficient to accurately reflect cure in DSO. CONCLUSIONS MOB-015 is a treatment option for onychomycosis with an AE profile similar to vehicle.",2020,"Complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% subjects, respectively (P=0.0195).","['North American study subjects with mild to moderate DSO involving 20-60% of at least one great toenail', 'distal and lateral subungual onychomycosis (DSO', 'mild-to-moderate distal subungual onychomycosis']","['MOB-015 or matching vehicle', 'topical terbinafine 10% solution (MOB-015']","['adverse event (AE) leading to discontinuation', 'Efficacy and safety', 'complete and mycological cure', 'efficacy and safety', 'mycological cure (negative culture and KOH) rate', 'Complete cure', 'mycological cure']","[{'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1274513', 'cui_str': 'Distal and lateral subungual onychomycosis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}]","[{'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}]",,0.185955,"Complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% subjects, respectively (P=0.0195).","[{'ForeName': 'Aditya K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Canada; Mediprobe Research Inc., London, Ontario, Canada. Electronic address: agupta@execulink.com.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Surprenant', 'Affiliation': 'Doctors Research Network, Miami, FL, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kempers', 'Affiliation': 'Minnesota Clinical Study Center, Fridley, MN, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc. Norfolk, VA, USA.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Rensfeldt', 'Affiliation': 'Settergatan, 2,11548, Stockholm, Sweden.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Tavakkol', 'Affiliation': 'Moberg Pharma AB (publ), Bromma, Sweden.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.055'] 2937,32585338,Targeting T cells in inflammatory bowel disease.,"T cells play a pivotal role in the immune response underlying inflammatory bowel disease (IBD) pathogenesis. On this basis, over the past 25 years several drugs have assessed to target T cells in IBD patients. Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only. The anti-CD4 BF-5 and cM-T412, and the anti-CD25 basiliximab and daclizumab were not effective in CD and UC patients, respectively. The anti-NKG2D antibody NNC0142-0002 showed clinical benefit in CD patients, in particular in biologic naïve ones, in a randomized, double-blind, parallel-group, placebo-controlled trial. The anti-CD40 L M90 and the GSK1349571A blocking calcium release-activated calcium (CRAC) channels, which are involved in the T cell activation and proliferation, were tested only in ex vivo/in vitro experiments. Apart from ustekinumab, all the other drugs targeting T cell-derived cytokines failed. The reinduction of lamina propria T cell apoptosis is a mechanism to modulate T cell survival exploited by cyclosporin A, azathioprine and anti-tumor necrosis factor-α agents, such as infliximab, adalimumab and golimumab. In this article, we review the drugs targeting T cells via surface receptors, via T cell-derived cytokines, via CRAC channels or by inducing apoptosis.",2020,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[""ulcerative colitis (UC) and Crohn's disease (CD) patients""]","['cyclosporin A, azathioprine', 'daclizumab', 'placebo']",[],"[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0961703,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giuffrida', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Sabatino', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. Electronic address: a.disabatino@smatteo.pv.it.'}]",Pharmacological research,['10.1016/j.phrs.2020.105040'] 2938,32585354,The Benefits and Costs of Changing Treatment Technique in Electroconvulsive Therapy Due to Insufficient Improvement of a Major Depressive Episode.,"BACKGROUND Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies. OBJECTIVE To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received. METHODS Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT. RESULTS Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT. CONCLUSIONS In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016'] 2939,32585392,"Randomized, double-blind, placebo-controlled clinical trial studying the effects of Turmeric in combination with mefenamic acid in patients with primary dysmenorrhoea.","Primary dysmenorrhea (PDM) is one of the common complaints in women. This study aimed to assess the effects of turmeric and mefenamic acid and a combination compared with placebo on PDM. This clinical trial was conducted on dormitory students with PDM. Subjects completed the visual analog scale (VAS) before randomization. One hundred twenty-eight patients, randomly assigned to one of following groups: Turmeric group (n = 32), mefenamic acid group (n = 32), turmeric and mefenamic acid group (n = 32), and placebo group (n = 32). Turmeric and mefenamic acid were administrated in 500 mg and 250 mg, respectively. Pain severity was assessed in the baseline and the end line by VAS. Statistical analysis was performed using SPSS software. The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups. Our results illustrated that combination of turmeric and mefenamic acid would be better in pain alleviation in PDM.",2020,"The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups.","['dormitory students with PDM', 'One hundred twenty-eight patients', 'patients with primary dysmenorrhoea']","['turmeric and mefenamic acid', 'mefenamic acid', 'Turmeric and mefenamic acid', 'placebo']","['visual analog scale (VAS', 'Pain severity', 'Primary dysmenorrhea (PDM', 'pain alleviation', 'alleviated pain']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041356', 'cui_str': 'Turmeric'}, {'cui': 'C0025152', 'cui_str': 'mefenamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}]",,0.179814,"The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups.","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Hesami', 'Affiliation': 'Student Research Committee, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kavianpour', 'Affiliation': 'Department of Tissue Engineering and Applied Cell Sciences, Faculty of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Rashidi Nooshabadi', 'Affiliation': 'Department of Pharmacology, School of Medicine, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Dept. of Obstetrics and Gynecology, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Lalooha', 'Affiliation': 'Dept. of Obstetrics and Gynecology, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khadem Haghighian', 'Affiliation': 'Student Research Committee, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: khademnut@yahoo.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101840'] 2940,32585438,Effect of in-bed cycling on acute muscle wasting in critically ill adults: A randomised clinical trial.,"PURPOSE To examine whether in-bed cycling assists critically ill adults to reduce acute muscle wasting, improve function and improve quality of life following a period of critical illness. MATERIALS AND METHODS A single-centre, two-group, randomised controlled trial with blinded assessment of the primary outcome was conducted in a tertiary ICU. Critically ill patients expected to be mechanically ventilated for at least 48 h were randomised to 30 min daily in-bed cycling in addition to usual-care physiotherapy (n = 37) or usual-care physiotherapy (n = 37). The primary outcome was muscle atrophy of rectus femoris cross-sectional area (RF CSA ) measured by ultrasound at Day 10 following study enrolment. Secondary outcomes included manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission. RESULTS Analysis included the 72 participants (mean age, 56-years; male, 68%) who completed the study. There were no significant between-group differences in muscle atrophy of RF CSA at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95). CONCLUSIONS AND RELEVANCE In-bed cycling did not reduce muscle wasting in critically ill adults, but this study provides useful effect estimates for large-scale clinical trials. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12616000948493.",2020,"There were no significant between-group differences in muscle atrophy of RF CSA at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95). ","['72 participants (mean age, 56-years; male, 68%) who completed the study', 'critically ill adults', 'Critically ill patients expected to be mechanically ventilated for at least 48\xa0h']","['anzctr.org.au Identifier', '30\xa0min daily in-bed cycling in addition to usual-care physiotherapy (n\xa0=\xa037) or usual-care physiotherapy', 'bed cycling']","['quality of life', 'manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission', 'muscle atrophy of rectus femoris cross-sectional area (RF CSA ', 'muscle atrophy of RF CSA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}]",,0.450536,"There were no significant between-group differences in muscle atrophy of RF CSA at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95). ","[{'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Nickels', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: marc.nickels@health.qld.gov.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Health Sciences, City, University of London, London, United Kingdom; Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. Electronic address: leanne.aitken.1@city.ac.uk.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: a.barnett@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: james.walsham@health.qld.gov.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: scott.king@health.qld.gov.au.'}, {'ForeName': 'Nicolette E', 'Initials': 'NE', 'LastName': 'Gale', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: nicolette.gale@health.qld.gov.au.'}, {'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Bowen', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: alicia.bowen@health.qld.gov.au.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Peel', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: brent.peel@health.qld.gov.au.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Donaldson', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: samuel.donaldson2@health.qld.gov.au.'}, {'ForeName': 'Stewart T J', 'Initials': 'STJ', 'LastName': 'Mealing', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: stewart.mealing@health.qld.gov.au.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Clinical Informatics, Metro South Health, Brisbane, Australia. Electronic address: steven.mcphail@qut.edu.au.'}]",Journal of critical care,['10.1016/j.jcrc.2020.05.008'] 2941,32590804,A new interspinous process distraction device BacFuse in the treatment of lumbar spinal stenosis with 5 years follow-up study.,"To explore a suitable indication of interspinous process distraction device for lumbar spinal stenosis with BacFuse.Patients of lumbar spinal stenosis (LSS) who experienced interspinous process distraction device surgery with BacFuse from June 2014 to January 2015 in our institute were included. We classified LSS into central and lateral types, and then divided these into severe and moderate according to the degree of stenosis. Each type was divided into 2 groups. Patients in group A underwent distraction without bone decompression (stand-alone), while patients in group B underwent bone decompression combined with distraction. Follow-up was performed at 1 month, 3 months, 6 months, 2 years, and 5 years after surgery. Zurich Claudication Questionnaire (ZCQ) was recorded to assess the patient's postoperative condition at each follow-up.A total of 142 patients were available for follow up at each time interval. There was a significant difference between the preoperative and final follow-up ZCQ scores for every LSS type. In addition, there was no difference between group A and group B in the postoperative ZCQ scores with the exception of the lateral severe type. In the study, 22 of the 23 patients (95.65%) in the lateral moderate type were considered to have a satisfactory result in group B, with a similar result of 93.33% (14/15) in group A (P = .75). In the lateral severe type, the patient satisfaction rate was 65.22% (15/23) and 90.63% (29/32) in group A and group B (P = .02), respectively. In the central moderate type, the patient satisfaction rate was 81.82% (15/23) and 76.92% (10/13) in group A and group B (P = .77), respectively. Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91). Moreover, no relationship was found between satisfaction and neurogenic intermittent claudication.The most suitable indication for BacFuse treatment was the lateral moderate type. For lateral severe patients, distraction combined with decompression is suggested for a higher satisfaction rate. Severe central spinal stenosis was shown to be a relative contraindication for BacFuse.",2020,"Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91).","['lumbar spinal stenosis with BacFuse', 'Patients of lumbar spinal stenosis (LSS) who experienced interspinous process distraction device surgery with BacFuse from June 2014 to January 2015 in our institute were included', '142 patients were available for follow up at each time interval']","['interspinous process distraction device', 'distraction without bone decompression (stand-alone', 'bone decompression combined with distraction']","['Severe central spinal stenosis', 'satisfaction and neurogenic intermittent claudication', 'patient satisfaction rate', 'postoperative ZCQ scores', 'Zurich Claudication Questionnaire (ZCQ', 'Satisfaction rate']","[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037944', 'cui_str': 'Spinal stenosis'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",142.0,0.020344,"Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91).","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': ''}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Ruideng', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020925'] 2942,32590809,"The efficacy and safety of sulforaphane as an adjuvant in the treatment of bipolar depressive disorder: Study protocol for a randomized, double-blinded, placebo-controlled, parallel-group clinical trial.","BACKGROUND Bipolar disorder (BD) is a chronic and disabling psychiatric disorder. The treatment of BD still remains a significant clinical challenge due to the complex nature of the disease. Nutraceutical therapy as adjunctive role is a promising therapy for BD. Sulforaphane (SFN), a broccoli extract, was reported to be effective for emotional problems and cognitive impairment. However, clinical research of SFN in the treatment of BD was rare. Therefore, this study is designed to evaluate the adjuvant role of SFN in the treatment of BD. METHODS This is a randomized, double-blinded, placebo-controlled, parallel-group clinical trial. A total of 100 patients who meet inclusion criteria will be assigned to receive quetiapine plus SFN or quetiapine plus placebo in a 1:1 ratio. The total duration of the study will be 12 weeks including 5 follow ups. The primary outcome is in the Montgomery-Asberg depression rating scale. The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora. Any adverse events will be recorded throughout the trial. DISCUSSION This trial will provide evidences to evaluate the efficacy and safety of SFN combined with quetiapine in the treatment of BD patients, as well as the adjuvant role of SFN in combination. TRIAL REGISTRATION This study protocol was registered at the Chinese clinical trial registry (ChiCTR2000028706).",2020,"The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora.","['bipolar depressive disorder', '100 patients who meet inclusion criteria will be assigned to receive']","['Sulforaphane (SFN), a broccoli extract', 'sulforaphane', 'quetiapine plus SFN or quetiapine plus placebo', 'SFN combined with quetiapine', 'SFN', 'placebo']","['efficacy and safety', 'Montgomery-Asberg depression rating scale', 'quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora']","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C4723687', 'cui_str': 'broccoli extract'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",100.0,0.340506,"The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora.","[{'ForeName': 'Congchong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Xingyang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Taizhou Second People's Hospital, Taizhou.""}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}]",Medicine,['10.1097/MD.0000000000020981'] 2943,32585185,"Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial.","BACKGROUND Mental health problems are a leading cause of disability in adolescents worldwide. Problem solving is a well-tested mental health intervention in many populations. We aimed to investigate the effectiveness of a brief, transdiagnostic problem-solving intervention for common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India. METHODS This randomised trial was done in six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities. We recruited participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment. Clinical eligibility criteria were assessed by research assistants using the Hindi-language version of the Strengths and Difficulties Questionnaire (SDQ), with reference to locally validated borderline cutoff scores of 19 or greater for boys and 20 or greater for girls on the SDQ Total Difficulties scale, an abnormal score of 2 or more on the SDQ Impact scale, and persistence of more than 1 month on the SDQ Chronicity index. Participants were randomly allocated (1:1) to problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group). Primary outcomes were adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP]) at 6 weeks. Primary analyses were done on an intention-to-treat basis at the 6-week endpoint. The trial is registered with ClinicalTrials.gov, NCT03630471. FINDINGS Participants were enrolled between Aug 20, and Dec 4, 2018. 283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys). 125 participants were allocated to each group (after accounting for one participant in the intervention group who withdrew consent after randomisation). Primary outcome data were available for 245 (98%) participants. At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61; p=0·0015). The mean SDQ Total Difficulties scores were 17·48 (5·45) in the intervention group and 18·33 (5·45) in the control group (-0·86, -2·14 to 0·41; 0·16, -0·09 to 0·41; p=0·18). We observed no adverse events. INTERPRETATION A brief lay counsellor-delivered problem-solving intervention combined with printed booklets seemed to have a modest effect on psychosocial outcomes among adolescents with diverse mental health problems compared with problem-solving booklets alone. This counsellor-delivered intervention might be a suitable first-line intervention in a stepped care approach, which is being evaluated in ongoing studies. FUNDING Wellcome Trust.",2020,"At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61;","['125 participants', 'adolescent mental health problems in urban, low-income schools in India', 'common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India', '283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys', 'adolescents with diverse mental health problems', 'participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment', 'six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities', 'Participants were enrolled between Aug 20, and Dec 4, 2018']","['problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group', 'lay counsellor-delivered problem-solving intervention combined with printed booklets', 'brief lay counsellor-delivered, problem-solving intervention', 'transdiagnostic problem-solving intervention']","['SDQ Total Difficulties scale', 'SDQ Chronicity index', 'psychosocial outcomes', 'mean YTP scores', 'mean SDQ Total Difficulties scores', 'adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0557802', 'cui_str': 'Specialist school'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547045', 'cui_str': 'Chronicity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",125.0,0.178681,"At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61;","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Malik', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'Sagath, New Delhi, India; Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Aoife M', 'Initials': 'AM', 'LastName': 'Doyle', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Bhat', 'Affiliation': 'Sangath, Goa, India.'}, {'ForeName': 'Rooplata', 'Initials': 'R', 'LastName': 'Sahu', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Bhagwant', 'Initials': 'B', 'LastName': 'Chilhate', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Krishna', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Paulomi', 'Initials': 'P', 'LastName': 'Sudhir', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; Harvard TH Chan School of Public Health, Boston, MA, USA. Electronic address: vikram_patel@hms.harvard.edu.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30173-5'] 2944,32585581,"Zataria multiflora affects clinical symptoms, oxidative stress and cytokines in asthmatic patient: A randomized, double blind, placebo-controlled, phase II clinical trial.","BACKGROUND Z. multiflora effect on clinical symptoms, pulmonary function tests (PFT), oxidative stress and cytokine levels in asthmatic patients were evaluated. METHODS 36 asthmatic patients were divided to; placebo group (P), two groups treated with Z. multiflora extract (5 and 10 mg/kg/day, as Z5 and Z10, respectively), (n = 12 in each group). Medications were administered three times a day for two months and several parameters were evaluated before treatment (step 0), one (step 1) and two months (step 2) after treatment. RESULTS Clinical symptoms and PFTs were significantly improved in Z5 and Z10 groups in steps 1 and 2 compared to step 0 (p < 0.05 to p < 0.001). Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001). CONCLUSION These results indicated therapeutic value of Z. multiflora for the management of asthma.",2020,"Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001). ","['36 asthmatic patients', 'asthmatic patient', 'asthmatic patients were evaluated']","['Zataria multiflora', 'Z. multiflora extract', 'placebo']","['oxidative stress, cytokines levels and their gene expression', 'Clinical symptoms and PFTs', 'clinical symptoms, pulmonary function tests (PFT), oxidative stress and cytokine levels']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",36.0,0.141139,"Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001). ","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Alavinezhad', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Ghorani', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rajabi', 'Affiliation': 'Department of Drug and Food Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: boskabadymh@mums.ac.ir.'}]",Cytokine,['10.1016/j.cyto.2020.155169'] 2945,32585668,Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial.,"OBJECTIVE To study the effect of intensive blood pressure reduction in patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial. DESIGN Randomized, multicenter, 2 group, open-label clinical trial. SETTING A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany. PATIENTS A total of 1,000 patients underwent randomization from May 2011 till September 2015. INTERVENTIONS We analyzed the effect of intensive (goal 110-139 mm Hg) over standard (goal 140-179 mm Hg) systolic blood pressure (SBP) reduction using intravenous nicardipine within 4.5 h of symptom onset in moderate to severe grade subjects with ICH in a non-prespecified analysis. Moderate to severe grade was defined by Glasgow Coma Scale score <13 or baseline National Institutes of Health Stroke Scale score ≥10 or baseline intraparenchymal hemorrhage volume ≥30 mL or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator. MEASUREMENTS AND MAIN RESULTS Of a total of 682 subjects who met the definition of moderate to severe grade (mean age 61.9 ± 13.1 years, 62.5% men) with a mean baseline SBP of 174.7 ± 24.8 mm Hg, the frequency of hematoma expansion was significantly lower among subjects randomized to intensive SBP reduction than among subjects randomized to standard SBP reduction (20.4 vs. 27.9%, relative risk [RR]: 0.7; 95% confidence interval [CI]: 0.55-0.96). The primary endpoint of death or disability was observed in 52.5% (170/324) of subjects receiving intensive SBP reduction and 48.9% (163/333) of subjects receiving standard SBP reduction (RR: 1.1; 95% CI: 0.9-1.2). CONCLUSIONS Intensive SBP lowering reduced the frequency of hematoma expansion but did not reduce the rate of death or disability in patients with moderate to severe grade ICH.",2020,"The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator. ","['patients with moderate to severe grade ICH', 'patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial', 'A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany', 'Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage', 'A total of 1,000 patients underwent randomization from May 2011 till September 2015', 'moderate to severe grade subjects with ICH in a non-prespecified analysis']","['intensive blood pressure reduction', 'nicardipine']","['frequency of hematoma expansion', 'Glasgow Coma Scale score', 'systolic blood pressure (SBP) reduction', 'rate of death or disability', 'standard SBP reduction', 'intensive SBP reduction', 'death or disability (score 4-6 on the modified Rankin scale', 'death or disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",1000.0,0.292665,"The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator. ","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA, qureshai@gmail.com.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Neurosciences Critical Care, Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine Baltimore, Baltimore, Maryland, USA.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506358'] 2946,32585670,Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study.,"INTRODUCTION Control of hyperphosphatemia in patients on dialysis remains a major challenge. OBJECTIVE This study evaluated predictors of serum phosphorus (sP) control among dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial. METHODS Post hoc analyses were performed using data for patients with hyperphosphatemia who received 52 weeks of treatment with sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer). Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52). Because SFOH and sevelamer have previously demonstrated similar effects on chronic kidney disease-mineral-bone disorder parameters in this study, the treatment groups were pooled. RESULTS Average age at baseline was higher among sP-controlled versus sP-uncontrolled patients (56.9 vs. 53.4 years; p = 0.005). Baseline sP levels were significantly lower among sP-controlled versus sP-uncontrolled patients (7.30 vs. 7.85 mg/dL; p < 0.001), and sP reductions from baseline were significantly greater in the sP-controlled group (-2.89 vs. -0.99 mg/dL at week 52; p < 0.001). Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]: 0.765-0.960), no concomitant active vitamin D therapy use (OR = 0.51, 95% CI: 0.328-0.804), and higher body mass index at baseline (OR = 0.96, 95% CI: 0.937-0.992) as significant predictors of uncontrolled sP. CONCLUSION This analysis indicates that sP control may be more challenging in younger patients with high sP levels. Closer monitoring and management of serum phosphorus levels may be required in this population.",2020,"Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]:","['younger patients with high sP levels', 'patients with hyperphosphatemia who received 52 weeks of treatment with', 'dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial', 'Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52']","['Sevelamer Carbonate', 'sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer']","['Baseline sP levels', 'chronic kidney disease-mineral-bone disorder parameters', 'higher body mass index', 'sP reductions']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4517624', 'cui_str': '195'}]","[{'cui': 'C1721288', 'cui_str': 'Sevelamer carbonate'}, {'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}, {'cui': 'C0718050', 'cui_str': 'sevelamer'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",302.0,0.0379352,"Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]:","[{'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Covic', 'Affiliation': 'Nephrology Clinic and Dialysis and Transplantation Center, Grigore T. Popa University of Medicine and Pharmacy, Iași, Romania, accovic@gmail.com.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, Illinois, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ketteler', 'Affiliation': 'Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Walpen', 'Affiliation': 'Department of Medical Affairs, Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Department of Biometrics, Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology, RWTH University Hospital Aachen, Aachen, Germany.'}]",Nephron,['10.1159/000507258'] 2947,32585673,"Training Skills in Minimally Invasive, Robotic and Open Surgery: Brain Activation as an Opportunity for Learning.","INTRODUCTION The advantages of the robotic approach in surgery are undisputed. However, during surgical training, how this technique influences the learning curve has not been described. We provide a tentative model for analyzing the learning curves associated with observation and active participation in learning different surgical techniques, using functional imaging. METHODS Forty medical students were enrolled and assigned to 4 groups who underwent training in robotic (ROB), laparoscopic (LAP), or open (OPEN) surgery, and a control group that performed motor training without surgical instruments. Surgical/motor training included six 1-h sessions completed over 6 days of the same week. All subjects underwent functional magnetic resonance imaging (fMRI) scanning sessions, before and after surgical training during. RESULTS Twenty-three participants completed the study. The 3 surgical groups exhibited different learning curves during training. The main effects of the day of training (p < 0.01) and the group (p < 0.01) as well as a significant interaction of day of training group (p < 0.01) were observed. The performance increased in the first 4 days, reaching a peak at day 4, when all groups were considered together. The OPEN group showed the best performance compared to all other groups (p < 0.04). The OPEN group showed a rapid improvement in performance, which peaked at day 4 and decreased on the last day. Similarly, the LAP group showed a steady increase in the number of exercises they completed, which continued for the entire training period and reached a peak on the last day. However, the participants training in ROB surgery, after a performance initially indistinguishable from that of the LAP group, had a dip in their performance, quickly followed by an improvement and reaching a plateau on day 4. fMRI analysis documented the different involvement of the cortical and subcortical areas based on the type of training. Surgical training modified the activation of some brain regions during both observation and the execution of tasks. CONCLUSIONS Differences in the learning curves of the 3 surgical groups were noted. Functional brain activity represents an interesting starting point to guide training programs.",2020,The OPEN group showed the best performance compared to all other groups (p < 0.04).,"['Forty medical students', 'Twenty-three participants completed the study']","['Minimally Invasive, Robotic and Open Surgery', 'training in robotic (ROB), laparoscopic (LAP), or open (OPEN) surgery, and a control group that performed motor training without surgical instruments', 'functional magnetic resonance imaging (fMRI) scanning sessions']",['number of exercises'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038928', 'cui_str': 'Surgical instrument'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",40.0,0.0177028,The OPEN group showed the best performance compared to all other groups (p < 0.04).,"[{'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Pelizzo', 'Affiliation': 'Department of Biomedical and Clinical Sciences ""L. Sacco"", University of Milan, Milan, Italy, gloriapelizzo@gmail.com.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Cardinali', 'Affiliation': 'CMoN, Cognition, Motion and Neuroscience Unit, Fondazione Istituto Italiano di Tecnologia, Genoa, Italy.'}, {'ForeName': 'Lilla', 'Initials': 'L', 'LastName': 'Bonanno', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino-Pulejo"", Messina, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marino', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino-Pulejo"", Messina, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cavaliere', 'Affiliation': 'IRCCS SDN, Istituto di Ricerca Diagnostica e Nucleare, Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Aiello', 'Affiliation': 'IRCCS SDN, Istituto di Ricerca Diagnostica e Nucleare, Naples, Italy.'}, {'ForeName': 'Placido', 'Initials': 'P', 'LastName': 'Bramanti', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino-Pulejo"", Messina, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Mazzon', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino-Pulejo"", Messina, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Soddu', 'Affiliation': 'Brain and Mind Institute, Department of Physics and Astronomy, Western University, London, Ontario, Canada.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Calcaterra', 'Affiliation': 'Pediatrics and Adolescentology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.'}]",European surgical research. Europaische chirurgische Forschung. Recherches chirurgicales europeennes,['10.1159/000507766'] 2948,32585686,Gonadotrophins or clomiphene citrate in women with normogonadotropic anovulation and CC failure: does the endometrium matter?,"STUDY QUESTION Is endometrial thickness (EMT) a biomarker to select between women who should switch to gonadotropins and those who could continue clomiphene citrate (CC) after six failed ovulatory cycles? SUMMARY ANSWER Using a cut-off of 7 mm for EMT, we can distinguish between women who are better off switching to gonadotropins and those who could continue CC after six earlier failed ovulatory CC cycles. WHAT IS ALREADY KNOWN For women with normogonadotropic anovulation, CC has been a long-standing first-line treatment in conjunction with intercourse or intrauterine insemination (IUI). We recently showed that a switch to gonadotropins increases the chance of live birth by 11% in these women over continued treatment with CC after six failed ovulatory cycles, at a cost of €15 258 per additional live birth. It is unclear whether EMT can be used to identify women who can continue on CC with similar live birth rates without the extra costs of gonadotropins. STUDY DESIGN, SIZE, DURATION Between 8 December 2008 and 16 December 2015, 666 women with CC failure were randomly assigned to receive an additional six cycles with a change to gonadotropins (n = 331) or an additional six cycles continuing with CC (n = 335), both in conjunction with intercourse or IUI. The primary outcome was conception leading to live birth within 8 months after randomisation. EMT was measured mid-cycle before randomisation during their sixth ovulatory CC cycle. The EMT was available in 380 women, of whom 190 were allocated to gonadotropins and 190 were allocated to CC. PARTICIPANTS/MATERIALS, SETTING, METHODS EMT was determined in the sixth CC cycle prior to randomisation. We tested for interaction of EMT with the treatment effect using logistic regression. We performed a spline analysis to evaluate the association of EMT with chance to pregnancy leading to a live birth in the next cycles and to determine the best cut-off point. On the basis of the resulting cut-off point, we calculated the relative risk and 95% CI of live birth for gonadotropins versus CC at EMT values below and above this cut-off point. Finally, we calculated incremental cost-effectiveness ratios (ICER). MAIN RESULTS AND THE ROLE OF CHANCE Mid-cycle EMT in the sixth cycle interacted with treatment effect (P < 0.01). Spline analyses showed a cut-off point of 7 mm. There were 162 women (45%) who had an EMT ≤ 7 mm in the sixth ovulatory cycle and 218 women (55%) who had an EMT > 7 mm. Among the women with EMT ≤ 7 mm, gonadotropins resulted in a live birth in 44 of 79 women (56%), while CC resulted in a live birth in 28 of 83 women (34%) (RR 1.57, 95% CI 1.13-2.19). Per additional live birth with gonadotropins, the ICER was €9709 (95% CI: €5117 to €25 302). Among the women with EMT > 7 mm, gonadotropins resulted in a live birth in 53 of 111 women (48%) while CC resulted in a live birth in 52 of 107 women (49%) (RR 0.98, 95% CI 0.75-1.29). LIMITATIONS, REASONS FOR CAUTION This was a post hoc analysis of a randomised controlled trial (RCT) and therefore mid-cycle EMT measurements before randomisation during their sixth ovulatory CC cycle were not available for all included women. WIDER IMPLICATIONS OF THE FINDINGS In women with six failed ovulatory cycles on CC and an EMT ≤ 7 mm in the sixth cycle, we advise switching to gonadotropins, since it improves live birth rate over continuing treatment with CC at an extra cost of €9709 to achieve one additional live birth. If the EMT > 7 mm, we advise to continue treatment with CC, since live birth rates are similar to those with gonadotropins, without the extra costs. STUDY FUNDING/COMPETING INTEREST(S) The original MOVIN trial received funding from the Dutch Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). C.B.L.A. reports unrestricted grant support from Merck and Ferring. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for Merck, ObsEva, IGENOMIX and Guerbet. All other authors have nothing to declare. TRIAL REGISTRATION NUMBER Netherlands Trial Register, number NTR1449.",2020,"Per additional live birth with gonadotropins, the ICER was €9709 (95% CI: €5117 to €25 302).","['380 women, of whom 190 were allocated to', '162 women (45%) who had an EMT\u2009≤\u20097\xa0mm in the sixth ovulatory cycle and 218 women (55%) who had an EMT\u2009>\u20097\xa0mm', 'women with normogonadotropic anovulation and CC failure', 'women who should switch to gonadotropins and those who could continue', 'Between 8 December 2008 and 16 December 2015, 666 women with CC failure']","['EMT', 'additional six cycles with a change to gonadotropins (n\xa0=\u2009331) or an additional six cycles continuing with CC (n\xa0=\u2009335), both in conjunction with intercourse or IUI', 'gonadotropins', 'clomiphene citrate (CC', 'Gonadotrophins or clomiphene citrate']","['live birth', 'chance of live birth', 'incremental cost-effectiveness ratios (ICER', 'live birth rate', 'conception leading to live birth']","[{'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0003128', 'cui_str': 'Anovulation'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",666.0,0.218287,"Per additional live birth with gonadotropins, the ICER was €9709 (95% CI: €5117 to €25 302).","[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Bordewijk', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Weiss', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Nahuis', 'Affiliation': 'Department of Obstetrics and Gynaecology, Noordwest Ziekenhuisgroep, Alkmaar, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kwee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Lambeek', 'Affiliation': 'Department of Obstetrics and Gynaecology, IJsselland Hospital, Capelle aan den Ijssel, Netherlands.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'van Unnik', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alrijne Hospital, Leiden, Netherlands.'}, {'ForeName': 'F P J', 'Initials': 'FPJ', 'LastName': 'Vrouenraets', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zuyderland Medical Center, Heerlen, Netherlands.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Cohlen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala Fertility Center, Zwolle, Netherlands.'}, {'ForeName': 'T A M', 'Initials': 'TAM', 'LastName': 'van de Laar-van Asseldonk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elkerliek Hospital, Helmond, Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, VU University, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Hompes', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, VU University, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'van der Veen', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa052'] 2949,32585914,Behavior Change Following Pain Neuroscience Education in Middle Schools: A Public Health Trial.,"Chronic pain and the opioid epidemic need early, upstream interventions to aim at meaningful downstream behavioral changes. A recent pain neuroscience education (PNE) program was developed and tested for middle-school students to increase pain knowledge and promote healthier beliefs regarding pain. In this study, 668 seventh-grade middle-school students either received a PNE lecture ( n = 220); usual curriculum school pain education (UC) ( n = 198) or PNE followed by two booster (PNEBoost) sessions ( n = 250). Prior to, immediately after and at six-month follow-up, pain knowledge and fear of physical activity was measured. Six months after the initial intervention school, physical education, recess and sports attendance/participation as well as healthcare choices for pain (doctor visits, rehabilitation visits and pain medication use) were measured. Students receiving PNEBoost used 30.6% less pain medication in the last 6 months compared to UC ( p = 0.024). PNEBoost was superior to PNE for rehabilitation visits in students experiencing pain ( p = 0.01) and UC for attending school in students who have experienced pain > 3 months ( p = 0.004). In conclusion, PNEBoost yielded more positive behavioral results in middle school children at six-month follow-up than PNE and UC, including significant reduction in pain medication use.",2020,PNEBoost was superior to PNE for rehabilitation visits in students experiencing pain ( p = 0.01) and UC for attending school in students who have experienced pain > 3 months ( p = 0.004).,"['middle school children', ' n = 220', 'Middle Schools', 'middle-school students', '668 seventh-grade middle-school students either received a']","['usual curriculum school pain education (UC) ( n = 198) or PNE followed by two booster (PNEBoost) sessions', 'PNE lecture']","['Chronic pain', 'positive behavioral results', 'pain medication', 'pain knowledge and fear of physical activity']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",668.0,0.0223239,PNEBoost was superior to PNE for rehabilitation visits in students experiencing pain ( p = 0.01) and UC for attending school in students who have experienced pain > 3 months ( p = 0.004).,"[{'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Louw', 'Affiliation': 'Evidence in Motion, Story City, IA 50248, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Landrus', 'Affiliation': 'Big Stone Therapies, Hendricks, MN 56136, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Podolak', 'Affiliation': 'Evidence in Motion Pain Fellowship, San Antonio, TX 78232, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Benz', 'Affiliation': 'Confluent Health, Siesta Key, FL 34242, USA.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'DeLorenzo', 'Affiliation': '180 Therapy and Wellness, Alexandria, VA 22314, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'St. Croix Regional Medical Center, St Croix Falls, WI 54024, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'SERC Physical Therapy, Webb City, MO 64870, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Physical Therapy of Concordia, Concordia, MO 64020, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Louw', 'Affiliation': 'Ortho Spine and Pain Clinic, Story City, IA 50248, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, University of South Dakota, Vermillion, SD 57069, USA.'}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Puentedura', 'Affiliation': 'Doctor of Physical Therapy Program, Robbins College of Health and Human Sciences, Baylor University, Waco, TX 76798-7303, USA.'}, {'ForeName': 'Merrill R', 'Initials': 'MR', 'LastName': 'Landers', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154-3029, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17124505'] 2950,32585923,A Process Evaluation Protocol for Examining the Impact of Instructions for Correct Use of Child Car Seats Designed through a Consumer-Driven Process and Evaluated in a Field-Based Randomised Controlled Trial.,"The incorrect use of child car seats is common, with significant negative effects on crash protection for child passengers. There is currently little evidence for effective, practical countermeasures for incorrect use. The provision of clear and comprehensible materials on correct use supplied with restraints at the point of sale could be highly cost-effective and achieve similar benefits to restraint-fitting services or hands-on training; however, routinely supplied instructions in their current form are frequently difficult to understand. We are conducting a randomised controlled trial of the consumer-driven redesign of instructional materials, consisting of an instruction sheet, swing tags and online training videos. This paper presents the protocol that will be used in an innovate process evaluation that will use the primary outcome of overall serious misuse assessed at six months, together with a survey and semi-structured interviews to determine fidelity, dose and outcomes for all intervention participants. The study will assess intervention delivery and external factors that may impact the effectiveness of the intervention, including experience, health literacy, confidence and attitudes. When it has been conducted, this process evaluation will provide enhanced understanding of the mechanisms through which the intervention works or not, aspects of the implementation process key to success of the intervention and insight into how external factors influence the success of the intervention.",2020,"We are conducting a randomised controlled trial of the consumer-driven redesign of instructional materials, consisting of an instruction sheet, swing tags and online training videos.",[],[],[],[],[],[],,0.054456,"We are conducting a randomised controlled trial of the consumer-driven redesign of instructional materials, consisting of an instruction sheet, swing tags and online training videos.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Elkington', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunter', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}, {'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Charlton', 'Affiliation': 'Monash University Accident Research Centre, Monash University, Melbourne 3800, Australia.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Bilston', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and Faculty of Medicine, University of New South Wales, Sydney 2031, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'School of Public Health, University of Technology Sydney, Sydney 2007, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Keay', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17124508'] 2951,32585945,Metagenomic Characterization of Gut Microbiota of Carriers of Extended-Spectrum Beta-Lactamase or Carbapenemase-Producing Enterobacteriaceae Following Treatment with Oral Antibiotics and Fecal Microbiota Transplantation: Results from a Multicenter Randomized Trial.,"Background: The R-GNOSIS (Resistance in Gram-Negative Organisms: Studying Intervention Strategies) WP3 study was the first multicenter randomized clinical trial systematically investigating fecal microbiota transplantation (FMT) for intestinal decolonization of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenemase-producing Enterobacteriaceae (CPE). Here, we characterized the temporal dynamics of fecal microbiota changes in a sub-cohort of the R-GNOSIS WP3 participants before and after antibiotics/FMT using whole metagenome shotgun sequencing. Methods: We sequenced fecal DNA obtained from 16 ESBL-E/CPE carriers having received oral colistin/neomycin followed by FMT and their corresponding seven donors. Ten treatment-naïve controls from the same trial were included. Fecal samples were collected at baseline (V0), after antibiotics but before FMT (V2) and three times after FMT (V3, V4 and V5). Results: Antibiotic treatment transiently decreased species richness and diversity and increased the abundance of antibiotic resistance determinants (ARDs). Bifidobacterium species, together with butyrate- and propionate-producing species from Lachnospiraceae and Ruminococcaceae families were significantly enriched in post-FMT microbiota of treated carriers. After FMT, the proportion of Enterobacteriaceae was lower compared to baseline but without statistical significance. Conclusions: Combined antibiotic and FMT treatment resulted in enrichment of species that are likely to limit the gut colonization by ESBL-E/CPE.",2020,"After FMT, the proportion of Enterobacteriaceae was lower compared to baseline but without statistical significance. ",['Gut Microbiota of Carriers of Extended-Spectrum Beta-Lactamase or Carbapenemase-Producing Enterobacteriaceae'],"['R-GNOSIS (Resistance in Gram-Negative Organisms', 'fecal microbiota transplantation (FMT', 'Oral Antibiotics and Fecal Microbiota Transplantation', 'antibiotic and FMT', 'CPE carriers', 'extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenemase-producing Enterobacteriaceae (CPE', 'oral colistin/neomycin followed by FMT']","['Fecal samples', 'abundance of antibiotic resistance determinants (ARDs', 'fecal microbiota changes', 'proportion of Enterobacteriaceae']","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C4039163', 'cui_str': 'Carbapenem resistant Enterobacteriaceae'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0010827', 'cui_str': 'Cytopathic effect'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C4511886', 'cui_str': 'ESBL (Extended spectrum beta-lactamase producing) Enterobacteriaceae'}, {'cui': 'C1444096', 'cui_str': 'ESBL'}, {'cui': 'C4039163', 'cui_str': 'Carbapenem resistant Enterobacteriaceae'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0027603', 'cui_str': 'Neomycin'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0014346', 'cui_str': 'Enterobacteriaceae'}]",,0.12825,"After FMT, the proportion of Enterobacteriaceae was lower compared to baseline but without statistical significance. ","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Leo', 'Affiliation': 'Genomic Research Laboratory, Division of Infectious Diseases, University Hospitals and University of Geneva, Rue Michel Servet 1, 1211 Geneva, Switzerland.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Lazarevic', 'Affiliation': 'Genomic Research Laboratory, Division of Infectious Diseases, University Hospitals and University of Geneva, Rue Michel Servet 1, 1211 Geneva, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Girard', 'Affiliation': 'Genomic Research Laboratory, Division of Infectious Diseases, University Hospitals and University of Geneva, Rue Michel Servet 1, 1211 Geneva, Switzerland.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Gaïa', 'Affiliation': 'Genomic Research Laboratory, Division of Infectious Diseases, University Hospitals and University of Geneva, Rue Michel Servet 1, 1211 Geneva, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Schrenzel', 'Affiliation': 'Genomic Research Laboratory, Division of Infectious Diseases, University Hospitals and University of Geneva, Rue Michel Servet 1, 1211 Geneva, Switzerland.'}, {'ForeName': 'Victoire', 'Initials': 'V', 'LastName': 'de Lastours', 'Affiliation': 'Division of Internal Medicine, Beaujon Hospital, APHP, Boulevard du Général Leclerc 100, 92110 Clichy, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fantin', 'Affiliation': 'Division of Internal Medicine, Beaujon Hospital, APHP, Boulevard du Général Leclerc 100, 92110 Clichy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Department of Medical Microbiology, University Medical Centre, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Carmeli', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, and Sackler Faculty of Medicine, Tel Aviv University, Weizmann Street 6, 6423906 Tel Aviv, Israel.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rondinaud', 'Affiliation': 'Department of Medical Microbiology, APHP, Bichat-Claude-Bernard Hospital, Rue Henri Huchard 46, 75018 Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, 1211 Geneva, Switzerland.'}, {'ForeName': 'Benedikt D', 'Initials': 'BD', 'LastName': 'Huttner', 'Affiliation': 'Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, 1211 Geneva, Switzerland.'}]",Microorganisms,['10.3390/microorganisms8060941'] 2952,32585974,Wheatgrass Juice Administration and Immune Measures during Adjuvant Chemotherapy in Colon Cancer Patients: Preliminary Results.,"Adjuvant chemotherapy is recommended in high-risk stage II-III colorectal cancer (CC). We examine the effect of daily wheatgrass juice (WGJ) intake in addition to chemotherapy on immune parameters, including IL-6, IL-8, IL-10, IL-12, and white blood cells (WBCs) among CC patients. In a controlled prospective trial, 100 stage II-III CC patients were enrolled. According to patient preference, they were divided into two subgroups, control group and intervention group, 50 patients each, all of whom received the same standard postoperative adjuvant chemotherapy, plus consumption of 60 cc WGJ daily in the intervention group. Blood samples were collected at baseline (T0) and upon treatment termination, 5-6 months later (T1). Cytokine concentrations were assessed using ELISA kits. Anti-inflammatory cytokine IL-10 concentrations were significantly higher in the WGJ group than in the control group at T1. The decline in WBC counts between T0 and T1 was significantly lower in the WGJ group. No significant differences were observed in IL-6, IL-8, and IL-12 concentrations between the study groups. The higher levels of IL-10 and the attenuating of WBC decline during chemotherapy may constitute preliminary evidence of the beneficial effects of WGJ on immune parameters, when given as a supplement to standard care. In light of these preliminary results, WGJ supports immunological parameters during adjuvant chemotherapy. Nevertheless, future studies are needed in order to translate those results to clinical recommendations for cancer survivors.",2020,"No significant differences were observed in IL-6, IL-8, and IL-12 concentrations between the study groups.","['100 stage II-III CC patients were enrolled', 'Colon Cancer Patients', 'high-risk stage II-III colorectal cancer (CC']","['Adjuvant chemotherapy', 'daily wheatgrass juice (WGJ', 'standard postoperative adjuvant chemotherapy, plus consumption of 60 cc WGJ daily in the intervention group', 'WGJ']","['IL-6, IL-8, and IL-12 concentrations', 'Blood samples', 'WBC counts', 'Cytokine concentrations', 'immune parameters, including IL-6, IL-8, IL-10, IL-12, and white blood cells (WBCs', 'Anti-inflammatory cytokine IL-10 concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1080691', 'cui_str': 'Genus Agropyron'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]",100.0,0.0450561,"No significant differences were observed in IL-6, IL-8, and IL-12 concentrations between the study groups.","[{'ForeName': 'Adva', 'Initials': 'A', 'LastName': 'Avisar', 'Affiliation': 'The Graduate Studies Authority, University of Haifa, Haifa 31000, Israel.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'School of Social Work, University of Haifa, Haifa 31000, Israel.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Clinical Immunology and Tissue Typing Lab, Rambam Medical Center, Haifa 31000, Israel.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Shentzer Kutiel', 'Affiliation': 'Division of Oncology, Rambam Health Care Campus, Haifa 31000, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Aharon', 'Affiliation': 'Hematology and Bone Marrow Transplantation, Sourasky Medical Center, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Bar-Sela', 'Affiliation': 'Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa 31000, Israel.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13060129'] 2953,32585997,Changes in the Intestinal Microbiome during a Multispecies Probiotic Intervention in Compensated Cirrhosis.,"Probiotics have been used in trials to therapeutically modulate the gut microbiome and have shown beneficial effects in cirrhosis. However, their effect on the microbiome of cirrhosis patients is not fully understood yet. Here, we tested the effects of a multispecies probiotic on microbiome composition in compensated cirrhosis. The gut microbiome composition of 58 patients with compensated cirrhosis from a randomized controlled trial who received a daily dose of multispecies probiotics or placebo for six months was analysed by 16S rRNA gene sequencing. Microbiome composition of patients who received probiotics was enriched with probiotic strains and the abundance of Faecalibacterium prausnitzii , Syntrophococcus sucromutans , Bacteroides vulgatus , Alistipes shahii and a Prevotella species was increased in the probiotic group compared to the placebo group. Patients who had microbiome changes in response to probiotic treatment also showed a significant increase in neopterin and a significant decrease in faecal zonulin levels after intervention, which was not observed in placebo-treated patients or patients with unchanged microbiome compositions. In conclusion, multispecies probiotics may enrich the microbiome of compensated cirrhotic patients with probiotic bacteria during a six-month intervention and beneficially change the residential microbiome and gut barrier function.",2020,"Microbiome composition of patients who received probiotics was enriched with probiotic strains and the abundance of Faecalibacterium prausnitzii , Syntrophococcus sucromutans , Bacteroides vulgatus , Alistipes shahii and a Prevotella species was increased in the probiotic group compared to the placebo group.","['58 patients with compensated cirrhosis', 'compensated cirrhosis']","['multispecies probiotics or placebo', 'Multispecies Probiotic Intervention', 'multispecies probiotic', 'placebo']","['microbiome composition', 'neopterin', 'faecal zonulin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",58.0,0.114675,"Microbiome composition of patients who received probiotics was enriched with probiotic strains and the abundance of Faecalibacterium prausnitzii , Syntrophococcus sucromutans , Bacteroides vulgatus , Alistipes shahii and a Prevotella species was increased in the probiotic group compared to the placebo group.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Durdevic', 'Affiliation': 'Center for Medical Research, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Division of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'di Vora', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rainer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Krones', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Douschan', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Spindelboeck', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Durchschein', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Zollner', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Rudolf E', 'Initials': 'RE', 'LastName': 'Stauber', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fickert', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Stiegler', 'Affiliation': 'Division of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stadlbauer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}]",Nutrients,['10.3390/nu12061874'] 2954,32586079,Effect of Tai Chi exercise with the same frequency and different exercise duration on the bone mineral density of older women.,"BACKGROUND This study compared the effect of Tai Chi with the same frequency and different session duration on the bone mineral density (BMD) of older women. METHODS Healthy older women aged 55-70 years were randomly divided into the short-time group (n=17), long-time group (n=18), and control group (n=17). The BMD of L2-4 and the proximal femur were measured at baseline and after 48 weeks of intervention. RESULTS From 0 to 48 weeks, the respective BMD values of L2-4 and the femoral neck in the short-time and long-time groups increased by 8.8% and 7.5% (P<0.01) and 8.8% and 12.7% (P<0.01), while the BMD of the greater trochanter in the control group decreased by 3.0% (P<0.05). After 48 weeks, the BMD of L2-4 and the femoral neck was greater in the short-time and long-time groups than the control group (P<0.001). CONCLUSIONS Tai Chi for 30 or 60 minutes five times weekly for 48 weeks improves the BMD of L2-4 and the femoral neck in older women, but does not affect the BMD of the greater trochanter and Ward's triangle. Increasing the exercise duration does not increase the effect of Tai Chi on BMD.",2020,"After 48 weeks, the BMD of L2-4 and the femoral neck was greater in the short-time and long-time groups than the control group (P<0.001). ","['older women', 'Healthy older women aged 55-70 years']","['Tai Chi', 'Tai Chi exercise']","['BMD of L2-4 and the femoral neck', 'BMD of the greater trochanter', 'BMD of L2-4 and the proximal femur', 'bone mineral density (BMD', 'respective BMD values of L2-4 and the femoral neck']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0223865', 'cui_str': 'Structure of greater trochanter of femur'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0408978,"After 48 weeks, the BMD of L2-4 and the femoral neck was greater in the short-time and long-time groups than the control group (P<0.001). ","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Chengdu Sport University, Chengdu, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Ba', 'Affiliation': 'Aba Teachers University, Shuimo, China - 380320557@qq.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10940-X'] 2955,32586139,Patients with Obesity Have Better Long-Term Outcomes after Hospitalization for COPD Exacerbation.,"Obesity has been shown to have a paradoxical benefit in a number of conditions, but the long-term effects in obesity after chronic obstructive pulmonary disease (COPD) exacerbation is still unclear. In this study, the effects of obesity on short- and long-term outcomes after a COPD exacerbation were evaluated. This was a secondary analysis of the Rapid Empiric Treatment with Oseltamivir Study (RETOS): a prospective, randomized, unblinded clinical trial. Patients were included in the study if they were hospitalized for acute exacerbation of COPD. Obesity was noted as patients with BMI >30. Clinical outcomes of time to clinical stability, length of stay, and mortality were compared. A total of 301 patients were included in the study, 122 (41%) patients were obese. There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity. Mortality for patients with and without obesity was 3% and 3% at 30 days, 7% and 18% at six months, and 8% and 28% at one year, respectively. After adjusting with multivariable regression analysis, patients with obesity had a significant reduction in odds of dying at one year (adjusted odds ratio (aOR): 0.18; 95% CI: 0.06-0.58; p  = .004) and at six months (aOR: 0.28; 95% CI: 0.09-0.89; p  = .031). Our study showed that obesity was associated with reduced mortality at one year and six months after a COPD exacerbation. Although patients with obesity had higher rates of comorbidities, they had reduced mortality at one year after multivariable regression analysis.",2020,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"['Patients were included in the study if they were hospitalized for acute exacerbation of COPD', 'A total of 301 patients were included in the study, 122 (41%) patients were obese', 'Patients with Obesity']",[],"['reduced mortality', 'Obesity', 'Mortality', 'time to clinical stability, length of stay, and mortality', 'length of stay and time to clinical stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",301.0,0.17615,There was no significant difference in the length of stay and time to clinical stability between patients with and without obesity.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'DeLapp', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Glick', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Furmanek', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Ramirez', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cavallazzi', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Disorders Medicine, University of Louisville School of Medicine, Louisville, KY, USA.'}]",COPD,['10.1080/15412555.2020.1781805'] 2956,32586143,On-treatment HDL cholesterol predicts incident atrial fibrillation in hypertensive patients with left ventricular hypertrophy.,"Purpose : Hypertensive patients are at increased risk of atrial fibrillation (AF). Although low baseline high density lipoprotein (HDL) cholesterol has been associated with a higher risk of AF, this has not been verified in recent population-based studies. Whether changing levels of HDL over time are more strongly related to the risk of new AF in hypertensive patients has not been examined. Material and methods : Incident AF was examined in relation to baseline and on-treatment HDL levels in 8267 hypertensive patients with no history of AF, in sinus rhythm on their baseline electrocardiogram, randomly assigned to losartan- or atenolol-based treatment. HDL levels at baseline and each year of testing were categorised into quartiles according to baseline HDL levels. Results : During 4.7 ± 1.10 years of follow-up, 645 patients (7.8%) developed new AF. In univariate Cox analyses, compared with the highest quartile of HDL levels (>1.78 mmol/l), patients with on-treatment HDL in the lowest quartile (1.21 mmol/l) had a 53% greater risk of new AF. Patients with on-treatment HDL in the second and third quartiles had intermediate increased risks of AF. Baseline HDL in the lowest quartile was not a significant predictor of new AF (hazard ratio (HR): 1.14, 95% confidence interval (CI): 0.90-1.43). In multivariable Cox analyses adjusting for multiple baseline and time-varying covariates, the lowest quartile of on-treatment HDL remained associated with a nearly 54% increased risk of new AF (HR: 1.54, 95% CI: 1.16-.05) whereas a baseline HDL ⩽1.21 mmol/l was not predictive of new AF (HR: 1.01, 95% CI: 0.78-1.31). Conclusion : Lower on-treatment HDL is strongly associated with risk of new AF. These findings suggest that serial assessment of HDL can estimate AF risk better than baseline HDL in hypertensive patients with left ventricular hypertrophy. Future studies may investigate whether therapies that increase HDL can lower risk of developing AF. Clinical Trials Registration : http://clinicaltrials.gov/ct/show/NCT00338260?order=1.",2020,Baseline HDL in the lowest quartile was not a significant predictor of new AF (hazard ratio (HR):,"['hypertensive patients', 'hypertensive patients with left ventricular hypertrophy', '8267 hypertensive patients with no history of AF, in sinus rhythm on their baseline electrocardiogram, randomly assigned to']","['losartan- or atenolol-based treatment', 'HDL']","['HDL levels', 'new AF', 'new AF (hazard ratio (HR', 'risk of atrial fibrillation (AF', 'risk of new AF', 'risks of AF']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",8267.0,0.0364102,Baseline HDL in the lowest quartile was not a significant predictor of new AF (hazard ratio (HR):,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Okin', 'Affiliation': 'Division of Cardiology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Darcy A', 'Initials': 'DA', 'LastName': 'Hille', 'Affiliation': 'Merck Research Labs, West Point, PA, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Wachtell', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sverre E', 'Initials': 'SE', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Stevo', 'Initials': 'S', 'LastName': 'Julius', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Devereux', 'Affiliation': 'Division of Cardiology, Weill Cornell Medical College, New York, NY, USA.'}]",Blood pressure,['10.1080/08037051.2020.1782171'] 2957,32586153,Percutaneous coronary intervention in the very elderly with NSTE-ACS: the randomized 80+ study.,"Objective: The treatment strategy in the very elderly with NSTE-ACS is debated, as they are often under-represented in clinical trials. The aim of this multicenter randomized controlled trial was to compare invasive and conservative strategies in the very elderly with NSTE-ACS. Methods: We randomly assigned patients ≥ 80 years of age with NSTE-ACS to an invasive strategy with coronary angiography and optimal medical treatment or a conservative strategy with only optimal medical treatment. The primary outcome was the combined endpoint of major adverse cardiac and cerebrovascular events (MACCE). Sample size was powered for a 50% reduction of event rate in MACCE with an invasive strategy. We used intention-to-treat analysis. Results: Altogether, 186 patients were included between 2009 and 2017. The study was terminated prematurely due to slow enrollment. At 12-month follow-up, the primary outcome occurred in 31 (33.3%) of the invasive treatment group and 34 (36.6%) of the conservative treatment group, with a hazard ratio (HR) of 0.90 (95% CI 0.55‒1.46; p  = 0.66) for the invasive group relative to the conservative group. The corresponding HR value for urgent revascularization was 0.29 (95% CI 0.10‒0.85; p  = 0.02), 0.56 (95% CI 0.27‒1.18; p  = 0.13) for myocardial infarction, 0.70 (95% CI 0.31‒1.58; p  = 0.40) for all-cause mortality, 1.35 (95% CI 0.23‒7.98; p  = 0.74) for stroke, and 1.62 (95% CI 0.67‒3.90; p  = 0.28) for recurrent hospitalization for cardiac reasons. Conclusion: In the very elderly with NSTE-ACS, we did not find any significant difference in MACCE between invasive and conservative treatment groups at 12-month follow-up, possibly due to small sample size. ClinicalTrials.gov: NCT02126202.",2020,The corresponding HR value for urgent revascularization was 0.29 (95% CI 0.10‒0.85; ,"['very elderly with NSTE-ACS', 'randomly assigned patients ≥ 80\u2009years of age with NSTE-ACS to an invasive strategy with', '186 patients were included between 2009 and 2017']","['Percutaneous coronary intervention', 'coronary angiography and optimal medical treatment or a conservative strategy with only optimal medical treatment']","['myocardial infarction', 'corresponding HR value for urgent revascularization', 'combined endpoint of major adverse cardiac and cerebrovascular events (MACCE', 'MACCE']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",186.0,0.156921,The corresponding HR value for urgent revascularization was 0.29 (95% CI 0.10‒0.85; ,"[{'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Hirlekar', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Berglind', 'Initials': 'B', 'LastName': 'Libungan', 'Affiliation': 'Department of Cardiology, University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Karlsson', 'Affiliation': 'Biostatistics, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bäck', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Herlitz', 'Affiliation': 'Centre for Pre-hospital Research, Faculty of Caring Science, Work Life and Social Welfare, University of Borås, Borås, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Albertsson', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2020.1781243'] 2958,32586176,"Re: Health Care Hotspotting-A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.217515,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171.02'] 2959,32586177,Re: Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression among Men with Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,,2020,,['Men with Early-Stage Prostate Cancer'],['Behavioral Intervention to Increase Vegetable Consumption'],['Cancer Progression'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}]",,0.0490649,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171'] 2960,32586190,"Re: The Daily Therapy with L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study.",,2020,,['Erectile Dysfunction'],"['L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy']",[],"[{'cui': 'C0242350', 'cui_str': 'Impotence'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1331168', 'cui_str': 'tadalafil 5 MG'}]",[],,0.018511,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001167.03'] 2961,32591219,Cognitive Behavioral Sex Therapy: An Emerging Treatment Option for Nonorganic Erectile Dysfunction in Young Men: A Feasibility Pilot Study.,"INTRODUCTION An increasing number of young men have been found to develop nonorganic erectile dysfunction (NOED) in recent years. The NOED has been shown to respond better to cognitive behavior sex therapy (CBST) in a few past studies. AIM The present research aims to establish the efficacy of CBST as a promising treatment option in young men suffering from NOED by administering a feasibility pilot trial. METHODS 28 young men (M = 31 years) out of a total of 39 men (7 excluded, 4 quit treatment) diagnosed with NOED from sexual health clinics in Pakistan were recruited to receive CBST treatment (n = 13) on average twice a week for a period of 50 minutes per session for a period of 4, 6, 8, and 12 weeks for the mild, mild to moderate, moderate, and severe forms of NOED, respectively, and sildenafil citrate group (n = 15) receiving sildenafil citrate 50 mg on demand. The trial design was sequential random assignment clinical trial. MAIN OUTCOME MEASURES International Index of Erectile Functoning-5 and Depression Anxiety Stress Scale-21 were used before treatment, after treatment, and in follow-up as the main outcome measures. RESULTS The repeated measures analysis of covariance established a nonsignificant difference between CBST and sildenafil citrate 50 mg in NOED scores improvement, NOED severity reduction, and reduction in depression scores at posttreatment assessment. There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores. There was significant difference in CBST and sildenafil citrate 50 mg in anxiety reduction at posttreatment assessment. The covariates age, age groups, and NOED duration did not significantly impact the treatment outcome for both treatment groups except age which impacted the interaction of treatment and anxiety scores. CONCLUSION The CBST is an emerging and promising treatment choice in younger men suffering from NOED. Bilal A, Abbasi NuH. Cognitive Behavioral Sex Therapy: An Emerging Treatment Option for Nonorganic Erectile Dysfunction in Young Men: A Feasibility Pilot Study. J Sex Med 2020;XX:XXX-XXX.",2020,"There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores.","['28 young men (M\xa0', 'Young Men', 'young men suffering from NOED', '31\xa0years) out of a total of 39 men (7 excluded, 4 quit treatment) diagnosed with NOED from sexual health clinics in Pakistan', 'younger men suffering from NOED']","['Cognitive Behavioral Sex Therapy', 'Abbasi NuH. Cognitive Behavioral Sex Therapy', 'CBST and sildenafil citrate', 'CBST', 'CBST treatment', 'sildenafil citrate 50\xa0mg on demand', 'sildenafil citrate']","['NOED scores improvement, NOED severity reduction, and reduction in depression scores', 'CBST and sildenafil citrate 50', 'International Index of Erectile Functoning-5 and Depression Anxiety Stress Scale-21', 'anxiety reduction', 'anxiety scores', 'NOED scores, reduction in NOED severity, and depression scores']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",28.0,0.0202324,"There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Bilal', 'Affiliation': 'PhD Research Scholar, Department of Psychology, International Islamic University, Islamabad, Pakistan. Electronic address: ahmadbilal4@gmail.com.'}, {'ForeName': 'Najam Ul Hasan', 'Initials': 'NUH', 'LastName': 'Abbasi', 'Affiliation': 'Assistant Professor, Department of Psychology, International Islamic University, Islamabad, Pakistan.'}]",Sexual medicine,['10.1016/j.esxm.2020.05.005'] 2962,32591238,D-cycloserine augmentation of cognitive behavioral therapy for delusions: A randomized clinical trial.,"OBJECTIVE D-cycloserine (DCS) promotes consolidation of extinction learning. This study extends earlier work by examining whether DCS can enhance cognitive behavioral therapy (CBT) for delusions. METHODS Adults reporting moderate or greater delusions were randomly assigned to receive 50 mg of DCS or placebo prior to 10 weekly CBT sessions. The primary outcome was change in severity of delusions measured with the Psychotic Symptom Rating Scale delusion subscale (PSYRATS-D). Secondary outcomes included persistence of response at 3 and 6 month follow-up and the effects of DCS on memory consolidation and cognitive flexibility. Fifty-eight participants were randomized and 44 completed the trial. RESULTS The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo. However, at the 3 month follow-up visit (week 24), 47% of participants who completed treatment with DCS reported a 20% or greater decrease on PSYRATS-D compared to 15% in the placebo group (p = .04). Change in distress across CBT sessions interacted with treatment group to predict change from baseline to week 24 in PSYRATS-D total score (p = .03) such that response at week 24 was greatest in DCS-treated participants who experienced a decrease in distress during CBT sessions. CONCLUSIONS DCS augmentation of CBT did not improve delusions compared to placebo during treatment; however, DCS was associated with a higher response rate at 3-month follow-up. DCS may produce a delayed therapeutic effect, associated with successful CBT sessions, but this finding requires replication.",2020,"The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo.","['delusions', 'Adults reporting moderate or greater delusions', 'Fifty-eight participants were randomized and 44 completed the trial']","['D-cycloserine (DCS', 'DCS or placebo', 'cognitive behavioral therapy', 'DCS', 'placebo']","['distress', 'delusions', 'persistence of response at 3 and 6\xa0month follow-up and the effects of DCS on memory consolidation and cognitive flexibility', 'memory consolidation or cognitive flexibility', 'response rate', 'change in severity of delusions measured with the Psychotic Symptom Rating Scale delusion subscale (PSYRATS-D']","[{'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3532768', 'cui_str': 'Psychotic symptom rating scales delusions subscale'}]",58.0,0.287105,"The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo.","[{'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Diminich', 'Affiliation': 'Program in Public Health and the Department of Family, Population and Preventive Medicine, Stony Brook University, Stony Brook, NY, United States of America.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt Health System, Baltimore, MD, United States of America.'}, {'ForeName': 'Iruma', 'Initials': 'I', 'LastName': 'Bello', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Rakhshan Rouhakhtar', 'Affiliation': 'Human Services Psychology Department, University of Maryland Baltimore County, Baltimore, MD, United States of America.'}, {'ForeName': 'Kamber L', 'Initials': 'KL', 'LastName': 'Hart', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York, NY, United States of America.'}, {'ForeName': 'Chenxiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Population Health, Division of Biostatistics, NYU School of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, Division of Biostatistics, NYU School of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York, NY, United States of America; Nathan Kline Institute for Psychiatric Research, Orangeburg, NY, United States of America. Electronic address: Donald.Goff@nyulangone.org.'}]",Schizophrenia research,['10.1016/j.schres.2020.06.015'] 2963,32591246,"The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE's ""M1|RT Comparison"".","BACKGROUND Prostate radiotherapy (RT) is a first-line option for newly diagnosed men with low-burden metastatic prostate cancer. The current criterion to define this clinical state is based on manual bone metastasis counts, but enumeration of bone metastases is limited by interobserver variations, and it does not account for metastasis volume or lesional coalescence. The automated bone scan index (aBSI) is a quantitative method of evaluating bone metastatic burden in a standardised and reproducible manner. OBJECTIVE To evaluate whether aBSI has utility as a predictive imaging biomarker to define a newly diagnosed metastatic prostate cancer population that might benefit from the addition of prostate RT to standard of care (SOC) systemic therapy. DESIGN, SETTING, AND PARTICIPANTS This is an exploratory analysis of men with newly diagnosed metastatic prostate cancer randomised in a 1:1 ratio to either SOC or SOC + prostate RT within the STAMPEDE ""M1|RT comparison"". INTERVENTION The SOC was lifelong androgen deprivation therapy, with up-front docetaxel permitted from December 2015. Men allocated RT received either a daily or a weekly schedule that was nominated before randomisation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Baseline bone scans were evaluated retrospectively to calculate aBSI. We used overall (OS) and failure-free (FFS) survival as the end points. Treatment-aBSI interaction was evaluated using the multivariable fractional polynomial interaction (MFPI) and subpopulation treatment effect pattern plot. Further analysis was done in aBSI quartiles using Cox regression models adjusted for stratification factors. RESULTS AND LIMITATIONS Baseline bone scans for 660 (SOC: 323 and SOC + RT: 337) of 2061 men randomised within the ""M1|RT comparison"" met the software requirements for aBSI calculation. The median age was 68 yr, median PSA was 100 ng/mL, median aBSI was 0.9, and median follow-up was 39 mo. Baseline patient characteristics including aBSI were balanced between the treatment groups. Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure). Graphical evaluation of estimated treatment effect plots showed that the OS and FFS benefit from prostate RT was greatest in patients with a low aBSI. Further analysis in quartiles based on aBSI supported this finding. CONCLUSIONS A low automated bone scan index is predictive of survival benefit associated with prostate RT in men with newly diagnosed metastatic prostate cancer. PATIENT SUMMARY The widely used bone scan can be evaluated using an automated technique to potentially select men with newly diagnosed metastatic prostate cancer who might benefit from prostate radiotherapy.",2020,"Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure).","['men with newly diagnosed metastatic prostate cancer who might benefit from prostate radiotherapy', 'newly diagnosed men with low-burden metastatic prostate cancer', 'men with newly diagnosed metastatic prostate cancer randomised in a 1:1 ratio to either', 'men with newly diagnosed metastatic prostate cancer', 'patients with a low aBSI', 'Men with Newly Diagnosed Metastatic Prostate Cancer', 'newly diagnosed metastatic prostate cancer population', 'Baseline bone scans for 660 (SOC: 323 and SOC\u2009+\u2009RT: 337) of 2061 men']","['aBSI', 'Prostate Radiotherapy', 'Prostate radiotherapy (RT', 'SOC or SOC\u2009+\u2009prostate RT']","['aBSI', 'overall (OS) and failure-free (FFS) survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",2061.0,0.146123,"Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure).","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Hoyle', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK; Department of Urology, The Salford NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Amos', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Calvert', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Douis', 'Affiliation': 'Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Malcolm D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK; Department of Urology, The Salford NHS Foundation Trust, Manchester, UK. Electronic address: noel.clarke@christie.nhs.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology oncology,['10.1016/j.euo.2020.05.003'] 2964,32591257,Racial differences in veterans' response to a standard vs. patient-centered decision aid for prostate cancer: Implications for decision making in African American and White men.,"OBJECTIVE To determine whether racial differences exist in patient preferences for prostate cancer treatment after being informed about options using a patient-centered vs. a standard decision aid (DA). METHODS This article reports secondary analyses of a large study of men diagnosed with early stage prostate cancer. Men were recruited from 4 VA Health Systems and randomized to receive a patient-centered or standard DA about prostate cancer treatment options. Data were collected at 1) baseline, 2) after reading the DA but prior to diagnosis, and 3) after receiving a cancer diagnosis and meeting with a urologist. RESULTS White patients who received the patient-centered DA written at a 7 th grade reading level were more likely to prefer active surveillance and less likely to prefer radiation compared to those who received the standard DA written at >9th grade reading level. African American patients' treatment preferences did not differ as a function of DA. CONCLUSIONS When informed about prostate cancer treatment options through a patient-centered DA, White patients changed their treatment preferences but African American patients did not. PRACTICE IMPLICATIONS As DAs are increasingly being used in clinical practice, more research is needed regarding the efficacy, relevance, and receptivity of DAs for African Americans.",2020,"African American patients' treatment preferences did not differ as a function of DA. ","['men diagnosed with early stage prostate cancer', 'African Americans', 'African American and White men']",['patient-centered or standard DA about prostate cancer treatment options'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0213559,"African American patients' treatment preferences did not differ as a function of DA. ","[{'ForeName': 'Aisha T', 'Initials': 'AT', 'LastName': 'Langford', 'Affiliation': 'Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA; Clinical and Translational Science Institute, New York University Grossman School of Medicine, New York, NY, USA. Electronic address: Aisha.Langford@nyulangone.org.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Scherer', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Denver, CO, USA; Colorado Program for Patient Centered Decisions at ACCORDS, University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ubel', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA; Fuqua School of Business, Duke University, Durham, NC, USA; Sanford School of Public Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Holmes-Rovner', 'Affiliation': 'Center for Ethics and Department of Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Scherr', 'Affiliation': 'Fuqua School of Business, Duke University, Durham, NC, USA; Department of Family Medicine and Community Health, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, UT, USA; Salt Lake City VA Informatics Decision-Enhancement and Analytic Sciences (IDEAS) Center for Innovation, Salt Lake City, UT, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.06.004'] 2965,32591421,"A Single Load of Fructose Attenuates the Risk of Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin: A Randomized, Open-Label, Crossover Proof-of-Principle Study.","OBJECTIVE While the adjustment of insulin is an established strategy to reduce the risk of exercise-associated hypoglycemia for individuals with type 1 diabetes, it is not easily feasible for those treated with ultra-long-acting basal insulin. The current study determined whether pre-exercise intake of fructose attenuates the risk of exercise-induced hypoglycemia in individuals with type 1 diabetes using insulin degludec. RESEARCH DESIGN AND METHODS Fourteen male adults with type 1 diabetes completed two 60-min aerobic cycling sessions with or without prior intake (30 min) of 20 g of fructose, in a randomized two-period crossover design. Exercise was performed in the morning in a fasted state without prior insulin reduction and after 48 h of standardized diet. The primary outcome was time to hypoglycemia (plasma glucose ≤3.9 mmol/L) during exercise. RESULTS Intake of fructose resulted in one hypoglycemic event at 60 min compared with six hypoglycemic events at 27.5 ± 9.4 min of exercise in the control condition, translating into a risk reduction of 87.8% (hazard ratio 0.12 [95% CI 0.02, 0.66]; P = 0.015). Mean plasma glucose during exercise was 7.3 ± 1.4 mmol/L with fructose and 5.5 ± 1.1 mmol/L in the control group ( P < 0.001). Lactate levels were higher at rest in the 30 min following fructose intake ( P < 0.001) but were not significantly different from the control group during exercise ( P = 0.32). Substrate oxidation during exercise did not significantly differ between the conditions ( P = 0.73 for carbohydrate and P = 0.48 for fat oxidation). Fructose was well tolerated. CONCLUSIONS Pre-exercise intake of fructose is an easily feasible, effective, and well-tolerated strategy to alleviate the risk of exercise-induced hypoglycemia while avoiding hyperglycemia in individuals with type 1 diabetes on ultra-long-acting insulin.",2020,Substrate oxidation during exercise did not significantly differ between the conditions ( P = 0.73 for carbohydrate and P = 0.48 for fat oxidation).,"['Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin', 'individuals with type 1 diabetes using insulin degludec', 'Fourteen male adults with type 1 diabetes', 'individuals with type 1 diabetes']","['Fructose', '60-min aerobic cycling sessions with or without prior intake (30 min) of 20 g of fructose']","['Lactate levels', 'Mean plasma glucose', 'tolerated', 'hypoglycemic event', 'time to hypoglycemia (plasma glucose ≤3.9 mmol/L) during exercise', 'Substrate oxidation during exercise']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0450403', 'cui_str': '20G'}]","[{'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",14.0,0.0650296,Substrate oxidation during exercise did not significantly differ between the conditions ( P = 0.73 for carbohydrate and P = 0.48 for fat oxidation).,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Kosinski', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Céline Isabelle', 'Initials': 'CI', 'LastName': 'Laesser', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christos T', 'Initials': 'CT', 'LastName': 'Nakas', 'Affiliation': 'Laboratory of Biometry, School of Agriculture, University of Thessaly, Nea Ionia Magnesia, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Melmer', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Laimer', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland christoph.stettler@insel.ch.'}]",Diabetes care,['10.2337/dc19-2250'] 2966,32591439,"Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment: The Systolic Blood Pressure Intervention Trial.","BACKGROUND Intensively treating hypertension may benefit cardiovascular disease and cognitive function, but at the short-term expense of reduced kidney function. METHODS We investigated markers of kidney function and the effect of intensive hypertension treatment on incidence of dementia and mild cognitive impairment (MCI) in 9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively). We categorized participants according to baseline and longitudinal changes in eGFR and urinary albumin-to-creatinine ratio. Primary outcomes were occurrence of adjudicated probable dementia and MCI. RESULTS Among 8563 participants who completed at least one cognitive assessment during follow-up (median 5.1 years), probable dementia occurred in 325 (3.8%) and MCI in 640 (7.6%) participants. In multivariable adjusted analyses, there was no significant association between baseline eGFR <60 ml/min per 1.73 m 2 and risk for dementia or MCI. In time-varying analyses, eGFR decline ≥30% was associated with a higher risk for probable dementia. Incident eGFR <60 ml/min per 1.73 m 2 was associated with a higher risk for MCI and a composite of dementia or MCI. Although these kidney events occurred more frequently in the intensive treatment group, there was no evidence that they modified or attenuated the effect of intensive treatment on dementia and MCI incidence. Baseline and incident urinary ACR ≥30 mg/g were not associated with probable dementia or MCI, nor did the urinary ACR modify the effect of intensive treatment on cognitive outcomes. CONCLUSIONS Among hypertensive adults, declining kidney function measured by eGFR is associated with increased risk for probable dementia and MCI, independent of the intensity of hypertension treatment.",2020,Incident eGFR <60 ml/min per 1.73 m 2 was associated with a higher risk for MCI and a composite of dementia or MCI.,"['hypertensive adults', '8563 participants who completed at least one', 'Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment', '9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively']",['intensive hypertension treatment'],"['incidence of dementia and mild cognitive impairment (MCI', 'eGFR and urinary albumin-to-creatinine ratio', 'dementia and MCI incidence', 'cognitive assessment', 'kidney events', 'probable dementia', 'occurrence of adjudicated probable dementia and MCI']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",9361.0,0.140303,Incident eGFR <60 ml/min per 1.73 m 2 was associated with a higher risk for MCI and a composite of dementia or MCI.,"[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Kurella Tamura', 'Affiliation': 'Geriatric Research and Education Clinical Center, Palo Alto VA Health Care System, Palo Alto, California mktamura@stanford.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Gordon J', 'Initials': 'GJ', 'LastName': 'Chelune', 'Affiliation': ""Center for Alzheimer's Care, Imaging and Research, University of Utah School of Medicine, Salt Lake City, Utah.""}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section of Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Departments of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Vascular Biology and Hypertension Program, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Supiano', 'Affiliation': 'Division of Geriatrics, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention and Division of Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020010038'] 2967,32586268,Combined high-intensity interval training and green tea supplementation enhance metabolic and antioxidant status in response to acute exercise in overweight women.,"Thirty sedentary overweight women were randomly assigned to three groups (n = 10), including HIIT + green tea, HIIT + placebo and green tea. The training program included 3 sessions/week HIIT while the supplement consuming groups took 3 * 500 mg of green tea tablets/day for 10 weeks. Results indicated that 10 weeks of HIIT and green tea meaningfully pronounced baseline serum levels of SIRT1 (P ≤ 0.0001), PGC-1α (P ≤ 0.0001) and CAT (P ≤ 0.0001). In addition, significant increase was observed in three indicators in HIIT + green tea group in comparison with two other research groups. Further, the responses of SIRT1 (P ≤ 0.01) and CAT (P ≤ 0.002) increased significantly to second acute exercise in all three groups. The combination of HIIT and green tea consumption may induce increasing SIRT1 and CAT in response to acute exercise and can improve antioxidant system, body composition and VO 2 max results rather than green tea and training alone, in young sedentary overweight women.",2020,"Further, the responses of SIRT1 (P ≤ 0.01) and CAT (P ≤ 0.002) increased significantly to second acute exercise in all three groups.","['young sedentary overweight women', 'Thirty sedentary overweight women', 'overweight women']","['Combined high-intensity interval training and green tea supplementation', 'HIIT and green tea consumption', 'HIIT\u2009+\u2009green tea, HIIT\u2009+\u2009placebo and green tea']","['responses of SIRT1', 'baseline serum levels of SIRT1', 'PGC-1α']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0655885,"Further, the responses of SIRT1 (P ≤ 0.01) and CAT (P ≤ 0.002) increased significantly to second acute exercise in all three groups.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Sport Sciences, Faculty of Literature and Humanities, University of Zabol, Zabol, Iran.'}, {'ForeName': 'Mohammad Esmaeil', 'Initials': 'ME', 'LastName': 'Afzalpour', 'Affiliation': 'Department of Exercise physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Shila', 'Initials': 'S', 'LastName': 'Nayebifar', 'Affiliation': 'Department of Sport Sciences, Faculty of Educational Sciences and Psychology, University of Sistan and Baluchestan, Zahedan, Iran. Shila_Nayebifar@ped.usb.ac.ir.'}]",The journal of physiological sciences : JPS,['10.1186/s12576-020-00756-z'] 2968,32586293,"A blended intervention to promote physical activity, health and work productivity among office employees using intervention mapping: a study protocol for a cluster-randomized controlled trial.","BACKGROUND Regular participation in moderate-to-vigorous physical activity (MVPA) is related to decreased risk of morbidity and mortality. Among working populations, lack of MVPA may also be a risk factor for absenteeism and presenteeism. Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity. However, several challenges limit their application in real world contexts. A 'blended' intervention approach combining the two intervention strategies is proposed to overcome these limitations. The proposed intervention aims to utilize the blended approach to increase participation in MVPA, health-related outcomes, and work productivity among inactive workers. METHODS The study will comprise of a three-group cluster randomized controlled trial (cluster-RCT), comprising a three-month actual intervention and a nine-month behavioral follow-up period. The three groups will be: a web-based intervention group, a blended intervention group combining the web-based components with face-to-face workshops and posters, and a control group. Physically inactive office employees (N = 495) from 33 companies (i.e., clusters) will be recruited and randomly assigned to the three groups by cluster randomization. The intervention mapping (IM) framework will be used for selecting and applying effective health behavioral theories and behavioral change techniques (BCTs) to the development, implementation and assessment of the intervention, which will be personally tailored. The primary outcome variable will be objectively-measured MVPA using an accelerometer. Secondary outcomes will consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, health-related quality of life and work-related variables including absenteeism and presenteeism. DISCUSSION The proposed study adopts a robust blended intervention approach that is expected to overcome challenges in applying workplace-based and web-based interventions separately and yield larger effects in promoting MVPA participation, health-related outcomes and work productivity. Improvements in work productivity outcomes will be of particular interest to employers. If more effective, the new blended intervention has the potential to be implemented on a larger scale to benefit workplace populations. TRIAL REGISTRATION The trial is prospectively registered at the ClinicalTrials.gov PRS (Trial ID: NCT04391270; Date of First Posted: May 18, 2020).",2020,"Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity.","['Physically inactive office employees (N\u2009=\u2009495) from 33 companies (i.e., clusters']","['blended intervention group combining the web-based components with face-to-face workshops and posters, and a control group']","['consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, health-related quality of life and work-related variables including absenteeism and presenteeism', 'objectively-measured MVPA using an accelerometer']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0879274,"Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Aiwei', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Siyue', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'Psychological Sciences, University of California, Merced, CA, USA.'}, {'ForeName': 'Xiangyan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Health Technology and Informatics, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Shirley Siu Ming', 'Initials': 'SSM', 'LastName': 'Fong', 'Affiliation': 'Department of Health and Physical Education, Education University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Wendy Yajun', 'Initials': 'WY', 'LastName': 'Huang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'LaPSCo, Physiological and Psychosocial Stress, CHU Clermont-Ferrand, Preventive and Occupational Medicine, Witty Fit, University Hospital of Clermont-Ferrand, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China. gaoyang@hkbu.edu.hk.'}]",BMC public health,['10.1186/s12889-020-09128-z'] 2969,32586344,"FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial.","BACKGROUND Acne vulgaris has increased in women over the past 10 years; it currently affects 20-30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis). The last alternative is represented by isotretinoin, but its use in women of childbearing potential is discouraged because of the teratogen risks. In this context, spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at the sebaceous gland and inhibits luteinizing hormone (LH) production at the pituitary level. It has no isotretinoin constraints and does not lead to bacterial resistance. Currently, very few studies have been performed in a limited number of patients: the studies showed that at low doses (lower than 200 mg/day), spironolactone can be effective against acne. In that context, it is clearly of interest to perform the first double-blind randomized study of spironolactone versus cyclines, which remains the moderate acne reference treatment, and to demonstrate the superiority of spironolactone's efficacy in order to establish it as an alternative to cyclines. METHODS Two hundred female patients will be included. They must have acne vulgaris with at least 10 inflammatory lesions and no more than 3 nodules. After randomization, the patients will be treated by spironolactone or doxycycline for 3 months and after placebo. The study will be blind for the first 6 months and open for the last 6 months. DISCUSSION The treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. TRIAL REGISTRATION ClinicalTrials.gov: NCT03334682. Registered on 7 November 2017.",2020,"In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. ","['Two hundred female patients will be included', 'women']","['FASCE', 'spironolactone or doxycycline', 'spironolactone', 'placebo']",[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],200.0,0.134613,"In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. ","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Poinas', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France. alexandra.poinas@chu-nantes.fr.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lemoigne', 'Affiliation': 'Dermatology Department, CHU Nantes, Nantes University, CRCINA, Nantes, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Le Naour', 'Affiliation': 'Dermatology Department, CHU Nantes, Nantes University, CRCINA, Nantes, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology and Biostatistics, CHU Nantes, Nantes, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Schirr-Bonnans', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes University, Nantes, France.'}, {'ForeName': 'Valery-Pierre', 'Initials': 'VP', 'LastName': 'Riche', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes University, Nantes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Vrignaud', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Machet', 'Affiliation': 'Department of Dermatology, CHU Tours, INSERM U1253, University of Tours, Tours, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Claudel', 'Affiliation': 'Private Practice, Tours, France.'}, {'ForeName': 'Marie-Thérèse', 'Initials': 'MT', 'LastName': 'Leccia', 'Affiliation': 'Department of Dermatology, Allergology and Photobiology, CHU A. Michallon, Grenoble, France.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Hainaut', 'Affiliation': 'Service de Dermatologie, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Beneton', 'Affiliation': 'Service de Dermatologie, Le Mans Hospital, Le Mans, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dert', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes University, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Boisrobert', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Flet', 'Affiliation': 'Department of Pharmacy, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chiffoleau', 'Affiliation': 'Direction de la Recherche, Département Promotion, Cellule Vigilances, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Corvec', 'Affiliation': 'CHU Nantes, Service de Bactériologie-Hygiène Hospitalière, CRCINA, INSERM, U1232, Université de Nantes, Nantes, France.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khammari', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dréno', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}]",Trials,['10.1186/s13063-020-04432-w'] 2970,32586348,"Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial.","BACKGROUND Moderate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients. Such pain may cause agitation, intracranial hypertension, epileptic seizures, and postoperative hematoma, which affect morbidity and mortality. Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy. In addition, the neurosurgery operation time is relatively long, but the duration of action of SNB is limited. It is generally believed that postoperative SNB is better than preoperative SNB for postoperative analgesia. However, considering the concept of preemptive analgesia, we believe that preoperative SNB may achieve a longer postoperative analgesia effect than we expected. METHODS This trial is a single-institution, prospective, randomized, controlled, double-blind study. A total of 180 children aged between 1 and 12 years who are undergoing elective craniotomy will be randomly allocated in a 1:1:1 ratio to three groups: group B (preoperative ropivacaine block group), group A (postoperative ropivacaine block group), and group N (nonblocking control group). This randomization will be stratified by age in two strata (1-6 years and 7-12 years). The primary outcome is the total consumption of sufentanil within 24 h after surgery. The secondary outcomes include assessment of pain scores, total consumption of sufentanil and emergency-remedy medicine consumption at observation points, the occurrence of postoperative complications, and the length of hospitalization after surgery. DISCUSSION This study is designed to explore the effect and feasibility of SNB with ropivacaine for postoperative analgesia in pediatric patients undergoing craniotomy. Further aims are to compare the effects of preoperative and postoperative SNB on postoperative analgesia in order to identify whether there is a preemptive analgesic effect and determine the better time to implement SNB in pediatric patients during craniotomy. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1800017386. Registered on 27 July 2018.",2020,"Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy.","['180 children aged between 1 and 12\u2009years who are undergoing elective craniotomy', 'pediatric patients', 'pediatric patients during craniotomy', 'pediatric patients undergoing craniotomy', 'pediatric craniotomy patients']","['ropivacaine block group), group A (postoperative ropivacaine block group), and group N (nonblocking control group', 'scalp nerve block (SNB', 'ropivacaine', 'SNB', 'placebo']","['postoperative analgesia effect', 'assessment of pain scores, total consumption of sufentanil and emergency-remedy medicine consumption at observation points, the occurrence of postoperative complications, and the length of hospitalization after surgery', 'total consumption of sufentanil within 24\u2009h after surgery']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",180.0,0.390615,"Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Pengwei', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Gaifen', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Lanxin', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China. jxsys2020@gmail.com.'}]",Trials,['10.1186/s13063-020-04524-7'] 2971,32586349,Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus.,"BACKGROUND It is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The relationship between outcomes chosen for comparative effectiveness research, outcomes used in decision-making in routine care, and outcome data recorded in electronic health records (EHR) is also poorly understood. The COMET Initiative (http://www.comet-initiative.org/. Accessed 3 Apr 2020) supports and encourages the development and use of 'core outcome sets' (COS), which represent the minimum set of patient health outcomes that should be measured and reported for a specific condition. There is growing interest in identifying how COS might fit into the different stages of the healthcare research and delivery ecosystem, and whether inclusion in the EHR might facilitate this. METHODS We sought to determine the degree of overlap between outcomes within COS for research and routine care, EMA, FDA and NICE guidelines, NICE quality statements/indicators, EHR and a point-of-care randomised clinical trial, using type 2 diabetes (T2D) as a case study. RESULTS There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR. CONCLUSIONS This case study has demonstrated the potential for efficient research and value-based healthcare when the EHR can include COS for both research and care, where the COS comprises outcomes of importance to all relevant stakeholders. However, this concordance may not hold more generally, as the focus on patient-centred outcomes may well be greater in T2D than in other conditions. Work is ongoing to examine other clinical areas, in order to highlight any current inefficiencies when health outcomes in research and healthcare do not agree with core outcomes identified by patients, clinicians and other key stakeholders.",2020,"There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR. ",[],[],[],[],[],[],,0.0462693,"There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR. ","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK. s.r.dodd@liv.ac.uk.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Harman', 'Affiliation': 'Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Taske', 'Affiliation': 'NICE Centre for Guidelines/Quality and Leadership Programme, Manchester, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Minchin', 'Affiliation': 'NICE Centre for Guidelines/Quality and Leadership Programme, Manchester, UK.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'NICE Centre for Guidelines/Quality and Leadership Programme, Manchester, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}]",Trials,['10.1186/s13063-020-04403-1'] 2972,32586394,Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol.,"OBJECTIVES To assess whether high doses of Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (i.e., Enoxaparin 4000 IU once day), in hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV], are: a)more effective in preventing clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were receiving standard oxygen therapy5.IMV in patients who at randomisation were receiving non-invasive mechanical ventilationb)Similar in terms of major bleeding risk TRIAL DESIGN: Multicentre, randomised controlled, superiority, open label, parallel group, two arms (1:1 ratio), in-hospital study. PARTICIPANTS Inpatients will be recruited from 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Disease Units and 1 Respiratory Disease Unit. INCLUSION CRITERIA (ALL REQUIRED) 1. Age > 18 and < 80 years 2. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) 3. Severe pneumonia defined by the presence of at least one of the following criteria: a.Respiratory Rate ≥25 breaths /minb.Arterial oxygen saturation≤93% at rest on ambient airc.PaO2/FiO2 ≤300 mmHg 4. Coagulopathy, defined by the presence of at least one of the following criteria: a.D-dimer >4 times the upper level of normal reference rangeb.Sepsis-Induced Coagulopathy (SIC) score >4 5. No need of IMV EXCLUSION CRITERIA: 1. Age <18 and >80 years 2. IMV 3. Thrombocytopenia (platelet count < 80.000 mm3) 4. Coagulopathy: INR >1.5, aPTT ratio > 1.4 5. Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation < 30 ml/min) 6. Known hypersensitivity to enoxaparin 7. History of heparin induced thrombocytopenia 8. Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant cancer at high risk of haemorrhage, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations) 9. Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves) 10. Concomitant double antiplatelet therapy 11. Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed 12. Pregnancy or breastfeeding or positive pregnancy test 13. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition) 14. Lack or withdrawal of informed consent INTERVENTION AND COMPARATOR: Control Group (Low-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at standard prophylactic dose (i.e., 4000 UI subcutaneously once day). Intervention Group (High-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at dose of 70 IU/kg every 12 hours, as reported in the following table. This dose is commonly used in Italy when a bridging strategy is required for the management of surgery or invasive procedures in patients taking anti-vitamin K oral anticoagulants Body Weight (kg)Enoxaparin dose every 12 hours (IU)<50200050-69400070-89600090-1108000>11010000 The treatment with Enoxaparin will be initiated soon after randomization (maximum allowed starting time 12h after randomization). The treatment will be administered every 12 hours in the intervention group and every 24 hours in the control group. Treatments will be administered in the two arms until hospital discharge or the primary outcomes detailed below occur. MAIN OUTCOMES Primary Efficacy Endpoint: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were in standard oxygen therapy by delivery interfaces5.Need for IMV, in patients who at randomisation were in Cpap or NIV Time to the occurrence of each of these events will be recorded. Clinical worsening will be analysed as a binary outcome as well as a time-to-event one. Secondary Efficacy Endpoints: Any of the following events occurring within the hospital stay 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were in standard oxygen therapy by delivery interfaces5.Need for IMV in patients who at randomisation were in Cpap or NIV6.Improvement of laboratory parameters of disease severity, including: o D-dimer levelo Plasma fibrinogen levelso Mean Platelet Volumeo Lymphocyte/Neutrophil ratioo IL-6 plasma levels MORTALITY AT 30 DAYS: Information about patients' status will be sought in those who are discharged before 30 days on Day 30 from randomisation. Time to the occurrence of each of these events will be recorded. Each of these events will be analysed as a binary outcome and as a time-to-event one. Primary safety endpoint: Major bleeding, defined as an acute clinically overt bleeding associated with one or more of the following: Decrease in haemoglobin of 2 g/dl or more;Transfusion of 2 or more units of packed red blood cells;Bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal];Bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death);Bleeding that necessitates surgical intervention Time to the occurrence of each of these events will be recorded. Each of these events will be analysed as a binary outcome and as a time-to-event one. Secondary safety endpoint: Clinically Relevant non-major bleeding, defined as an acute clinically overt bleeding that does not meet the criteria for major and consists of: 1.Any bleeding compromising hemodynamic2.Spontaneous hematoma larger than 25 cm2, or 100 cm2 if there was a traumatic cause3.Intramuscular hematoma documented by ultrasonography4.Epistaxis or gingival bleeding requiring tamponade or other medical intervention5.Bleeding from venipuncture for >5 minutes6.Haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures7.Haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention8.Any other bleeding requiring temporary cessation of a study drug. Time to the occurrence of each of these events will be recorded. Each of these events will be analysed as a binary outcome and as a time-to-event one. RANDOMISATION Randomisation (with a 1:1 randomisation ratio) will be centrally performed by using a secure, web-based system, which will be developed by the Methodological and Statistical Unit at the Azienda Ospedaliero-Universitaria of Modena. Randomisation stratified by 4 factors: 1) Gender (M/F); 2) Age (<75/≥75 years); 3) BMI (<30/≥30); 4) Comorbidities (0-1/>2) with random variable block sizes will be generated by STATA software. The web-based system will guarantee the allocation concealment. Blinding (masking) The study is conceived as open-label: patients and all health-care personnel involved in the study will be aware of the assigned group. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The target sample size is based on the hypothesis that LMWH administered at high doses versus low doses will significantly reduce the risk of clinical worsening. The overall sample size in this study is expected to be 300 with 150 in the Low-Dose LMWH control group and 150 in the High-Dose LMWH intervention group, recruited over 10-11 months. Assuming an alpha of 5% (two tailed) and a percentage of patients who experience clinical worsening in the control group being between 25% and 30%, the study will have 80% power to detect at least 50% relative reduction in the risk of death between low and high doses of heparin. TRIAL STATUS Protocol version 1.2 of 11/05/2020. Recruitment start (expected): 08/06/2020 Recruitment finish (expected): 30/04/2021 Trial registration EudraCT 2020-001972-13, registered on April 17th, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Coagulopathy: INR >1.5, aPTT ratio","['Inpatients will be recruited from 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Disease Units and 1 Respiratory Disease Unit', 'hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD', 'Age', 'Randomisation stratified by 4 factors: 1) Gender (M/F); 2) Age (<75/≥75 years); 3) BMI (<30/≥30); 4) Comorbidities (0-1/>2) with random variable block sizes will be generated by STATA software', 'hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV', 'Age > 18 and < 80 years 2']","['IMV', 'D-dimer', 'high versus low Low-Molecular Weight Heparin', 'LMWH', 'Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb', 'standard oxygen therapy5.IMV', 'LMWH intervention', 'aPTT ratio', 'Enoxaparin', 'standard oxygen therapy', 'Intervention Group (High-Dose LMWH', 'heparin', 'Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin', 'Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material', 'Control Group (Low-Dose LMWH', 'Enoxaparin (Inhixa®', 'enoxaparin', 'LMWH, fondaparinux, or unfractionated heparin (UFH']","['Thrombocytopenia', 'risk of death', 'symptomatic arterial or venous thromboembolism', 'Impaired renal function (eGFR', 'occurrence of at least one of the following events', 'hospital stay 1.Death2.Acute Myocardial Infarction', 'Relevant non-major bleeding, defined as an acute clinically overt bleeding that does not meet the criteria for major and consists of: 1.Any bleeding compromising hemodynamic2.Spontaneous hematoma larger', 'Sepsis-Induced Coagulopathy (SIC) score', 'levelso Mean Platelet Volumeo Lymphocyte/Neutrophil ratioo IL-6 plasma levels', 'bleeding, defined as an acute clinically overt bleeding associated with one or more of the following: Decrease in haemoglobin of 2 g/dl or more;Transfusion of 2 or more units of packed red blood cells;Bleeding', 'Severe pneumonia', 'life expectancy']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0449209', 'cui_str': 'ORB'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1098510', 'cui_str': 'fondaparinux'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",,0.138155,"Coagulopathy: INR >1.5, aPTT ratio","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marietta', 'Affiliation': 'Dipartimento Oncologia ed Ematologia, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy. marco.marietta@unimore.it.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vandelli', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Mighali', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Vicini', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Coluccio', 'Affiliation': 'Dipartimento Oncologia ed Ematologia, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04475-z'] 2973,32586395,"A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial"".","OBJECTIVES Primary Objective: The primary objective is to reduce initiation of mechanical ventilator dependency in patients with moderate to severe CoViD- 19. This will be measured as the difference between the control group and active group for subjects admitted to the hospital for CoViD-19. Secondary Objectives: • To evaluate cytokine trends / Prevent cytokine storms • To evaluate supplemental oxygen requirements • To decrease mortality of CoViD-19 patients • Delay onset of ventilation TRIAL DESIGN: The study is a single centre, 2-arm, prospective, randomized (ratio 1:1), controlled trial with parallel groups design to compare the reduction of respiratory distress in a CoViD-19 population, using the intervention of the gammaCore®-Sapphire device plus standard of care (active) vs. standard of care alone (SoC) - the control group. The gammaCore® treatments will be used acutely and prophylactically. The active and control groups will be matched for disease and severity. PARTICIPANTS i. Inclusion Criteria The subjects have to meet all of the following criteria to be eligible to enter the trial: 1.Patient older than 18 years2.Been tested positive or suspected/presumed positive for CoViD-19 Has a cough, shortness of breath or respiratory O 2 Saturation less than or equal to 92% without need for mechanical ventilation or acute respiratory failure 3.Agree to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data4.Patient is able to provide signed and witnessed Informed Consent ii. Exclusion Criteria Subjects meeting any of the following criteria cannot be included in this research study: 1.Pregnant women2.On home/therapy oxygen (i.e. for patients with Chronic Obstructive Pulmonary Disease) at baseline prior to development of CoViD-193.Patient already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-194.History of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma5.Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction6.Uncontrolled high blood pressure (>140/90)7.Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant8.Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site9.Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner) Participants will be recruited from Hospital Clínico Universitario de Valencia in Spain. INTERVENTION AND COMPARATOR Intervention: Prophylactic: Administer 2 doses (at 2 minutes each) of gammaCore® - Sapphire, one dose on each side of the neck scheduled three times a day (morning, mid-day and 1 hour before bed at night).Acute respiratory failure or shortness of breath: Administer 2 doses (at 2 minutes each) of gammaCore®-Sapphire, one on each side of the neck. If shortness of breath (SOB) persists 20 minutes after the start of the first treatment, a second dose will be administered. Max doses per day is 9 or 18 stimulations.Plus standard of care Control: Standard of care: oxygen therapy, antibiotics and ventilatory support if necessary depending on the clinic MAIN OUTCOMES: Primary Endpoint: Initiation of mechanical ventilation, from randomization until ICU admission or hospital discharge, whatever occurs first Secondary Endpoints: Safety; ascertainment of Adverse Effects/Serious Adverse Events, from randomisation to ICU admission or hospital discharge, whatever occurs firstCytokine Storm measured by: Tumor necrosis factor α, Interleukin 6, Interleukin 1β. Days 1,3,5,10,15 and/or at hospital dischargeMortality and/or need for Critical Care admission, from randomisation until ICU admission or hospital discharge, whatever occurs first,O2 saturation levels , from randomization until ICU admission or hospital discharge, whatever occurs firstNeed for supplemental oxygen, from randomisation until ICU admission or hospital discharge, whatever occurs first RANDOMISATION: The patients are classified according to their oxygen levels as mild, moderate and severe and randomized according to their classification to the intervention and control in a ratio of 1:1. The randomization will be stratified for gender and age. BLINDING (MASKING) This is an open label study, it is not possible to blind the participants and healthcare providers to the intervention. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The total number of patients to be included in the study is 90, with 45 in each study group TRIAL STATUS: The protocol version is 8.0 from 07 th April 2020. The recruitment began 20th April 2020 and is expected to be complete 31st July 2020. TRIAL REGISTRATION The study is registered in clinicaltrials.gov on 29th April 2020 with the identification number: NCT04368156 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Storm measured by: Tumor necrosis factor α, Interleukin 6, Interleukin 1β.","['patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR', 'patients with Chronic Obstructive Pulmonary Disease) at baseline prior to development of CoViD-193.Patient already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-194.History of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma5.Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction6.Uncontrolled high blood pressure ', 'patients with moderate to severe CoViD- 19', '1.Patient older than 18 years2.Been tested positive or suspected/presumed positive for CoViD-19 Has a cough, shortness of breath or respiratory O 2 Saturation less than or equal to 92% without need for mechanical ventilation or acute respiratory failure 3.Agree', 'CoViD-19 patients •', 'homeless, developmentally disabled and prisoner', 'i. Inclusion Criteria', 'Participants will be recruited from Hospital Clínico Universitario de Valencia in Spain']","['gammaCore®-Sapphire device', 'gammaCore®-Sapphire device plus standard of care (active) vs. standard of care alone (SoC) - the control group']","['ICU admission or hospital discharge, whatever occurs firstCytokine', 'respiratory distress', 'Tumor necrosis factor α, Interleukin 6, Interleukin 1β', 'mortality', 'mechanical ventilator dependency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0007273', 'cui_str': 'Disorder of carotid artery'}, {'cui': 'C0006318', 'cui_str': 'Bruit'}, {'cui': 'C0455536', 'cui_str': 'H/O: TIA'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4303880', 'cui_str': 'Presumptive positive'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C2733607', 'cui_str': 'Developmentally disabled'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0086954', 'cui_str': 'Sapphire'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042497', 'cui_str': 'Mechanical ventilator'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]",,0.161092,"Storm measured by: Tumor necrosis factor α, Interleukin 6, Interleukin 1β.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tornero', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain. carlostornero@gmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vallejo', 'Affiliation': 'Department of Basic Science, Millennium Pain Center, Bloomington, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cedeño', 'Affiliation': 'Department of Basic Science, Millennium Pain Center, Bloomington, IL, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Orduña', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Pastor', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Belaouchi', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Benigno', 'Initials': 'B', 'LastName': 'Escamilla', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Mar Garzando', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}]",Trials,['10.1186/s13063-020-04486-w'] 2974,32586396,"CytoResc - ""CytoSorb"" Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES Approximately 8 - 10 % of COVID-19 patients present with a serious clinical course and need for hospitalization, 8% of hospitalized patients need ICU-treatment. Currently, no causal therapy is available and treatment is purely supportive. The main reason for death in critically ill patients is acute respiratory failure. However, in a number of patients a severe hyperinflammatory response with excessively elevated proinflammatory cytokines causes vasoplegic shock resistant to vasopressor therapy. A new polystyrene-based hemoadsorber (CytoSorb®, Cytosorbents Inc., New Jersey, USA) has been shown to adsorb effectively cytokines and other middle molecular weight toxins this way reducing their blood concentrations. This has been routinely used in clinical practice in the EU for other conditions where a cytokine storm occurs and an observational study has just been completed on COVID-19 patients. We hypothesized that the extracorporeal elimination of cytokines in critically ill COVID-19 patients with suspected hyperinflammation and shock may stabilize hemodynamics and improve outcome. The primary endpoint is time until resolution of vasoplegic shock, which is a well implemented, clinically relevant endpoint in critical care studies. TRIAL DESIGN Phase IIb, multicenter, prospective, open-label, randomized, 1:1 parallel group pilot study comparing the additional use of ""CytoSorb"" to standard of care without ""CytoSorb"". PARTICIPANTS Patients are recruited from the Intensive Care Units (ICUs) of 7 participating centers in Germany (approximately 10 ICUs). All patients aged 18- 80 with positive polymerase chain reaction (PCR) test for SARS-CoV-2, a C-reactive protein (CRP) ≥ 100 mg/l, a Procalcitonin (PCT) < 2 ng/l, and suspected cytokine storm defined via a vasoplegic shock (Norepinephrine > 0.2 μg/min/kg to achieve a Mean Arterial Pressure ≥ 65mmHg). Patients are included irrespective of indication for renal replacement therapy. Suspected or proven bacterial cause for vasoplegic shock is a contraindication. INTERVENTION AND COMPARATOR Within 24 hours after meeting the inclusion criteria patients will be randomized to receive either standard of care or standard of care and additional ""CytoSorb"" therapy via a shaldon catheter for 3-7 days. Filter exchange is done every 24 hours. If patients receive antibiotics, an additional dose of antibiotics is administered after each change of ""CytoSorb"" filter in order to prevent underdosing due to ""CytoSorb"" treatment. MAIN OUTCOMES Primary outcome is time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAP ≥ 65mmHg) in days. Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury. RANDOMIZATION An electronic randomization will be performed using the study software secuTrial® administered by the Clinical Study Center (CSC) of the Charité - Universitätsmedizin Berlin, Germany. Randomization is done in blocks by 4 stratified by including center. BLINDING (MASKING) The trial will be non-blinded for the clinicians and patients. The statistician will receive a blinded data set, so that all analyses will be conducted blinded. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) As this is a pilot study with the goal to examine the feasibility of the study design as well as the intervention effect, no formal sample size calculation was conducted. A total number of approximately 80-100 patients is planned (40-50 patients per group). Safety assessment is done after the inclusion of each 10 patients per randomization group. TRIAL STATUS Please see the study protocol version from April 24 2020. Recruitment of patients is still pending. TRIAL REGISTRATION The study was registered on April 27 2020 in the German Registry of Clinical Trials (DRKS) under the number DRKS00021447. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury. ","['Patients are recruited from the Intensive Care Units (ICUs) of 7 participating centers in Germany (approximately 10 ICUs', 'critically ill patients undergoing the COVID-19 Cytokine Storm', 'The study was registered on April 27 2020 in the German Registry of Clinical Trials (DRKS) under the number DRKS00021447', 'All patients aged 18- 80 with positive polymerase chain reaction (PCR) test for SARS-CoV-2, a C-reactive protein (CRP) ≥']","['standard of care or standard of care and additional ""CytoSorb"" therapy via a shaldon catheter', 'CytoResc - ""CytoSorb"" Rescue', 'CytoSorb"" to standard of care without ""CytoSorb']","['7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury', 'time until resolution of vasoplegic shock, which is a well implemented, clinically relevant endpoint in critical care studies', 'time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAP ≥ 65mmHg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",,0.41212,"Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury. ","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Stockmann', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Institute for Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Büttner', 'Affiliation': 'Department of Nephrology, Clinic Aschaffenburg-Alzenau, Aschaffenburg, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Jörres', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Kindgen-Milles', 'Affiliation': 'Department of Anesthesiology, University Hospital Düsseldorf, Heinrich-Heine-University Duesseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Julius Valentin', 'Initials': 'JV', 'LastName': 'Kunz', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Leebmann', 'Affiliation': 'Interdisciplinary Apheresis Center at Passau General Hospital, Passau, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin (CCM, CVK), Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Träger', 'Affiliation': 'Department of Cardiac Anesthesiology, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Treskatsch', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin (CBF), Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Uhrig', 'Affiliation': 'Department of Internal Medicine/Infectious Diseases and Pulmonary Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Willam', 'Affiliation': 'Department of Internal Medicine 4-Nephrology and Hypertension, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Enghard', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Slowinski', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany. torsten.slowinski@charite.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04501-0'] 2975,32586399,Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES Tissue hypoxia is the main cause of multi-organ dysfunction in sepsis. However, effective pharmacological treatments to combat sepsis-induced tissue hypoxia are not available. Emerging experimental and clinical evidence reveals an evolutionary conserved action of thyroid hormone (TH) to adapt injured tissue to hypoxic conditions via its action on p38 MAPK, Akt signaling pathways. In addition, TH has favorable effects on the immune system and viral load in infected tissue. Non-Thyroid Illness Syndrome is common in sepsis, acute myocardial infarction and trauma and is associated with increased mortality. Thus, TH may be a novel treatment in the setting of critical illness due to viral infection in which hypoxia prevails. The present study aims to address the efficacy and safety of acute administration of triiodothyronine (T3) in critically ill COVID-19 infected patients requiring mechanical respiratory support or Extra Corporeal Membrane Oxygenation (ECMO). TRIAL DESIGN This study is a phase II, parallel, 2-arm (1:1 ratio), multi-centre, prospective, randomized, double-blind, placebo controlled trial. PARTICIPANTS Male and female patients aged over 18 years old who are diagnosed with pulmonary infection due to COVID-19, admitted to Intensive Care Unit and requiring mechanical ventilation or ECMO will be enrolled in this trial. Patients will be excluded in cases of pregnancy, severe systemic disease with life expectancy less than 6 months, participation in another trial of an investigational drug or device, corticosteroid and/or sympathomimetic use before initiation of treatment. All data will be collected in electronic CRF files. Participants will start to be recruited from the ICU center of ""ATTIKO"" University Hospital in Greece. We aim to include two more clinical sites in the trial one from Greece and one from Germany INTERVENTION AND COMPARATOR: Intervention: T3 Solution for injection 10 μg/ml. The dose administered will be 0.8g/kg i.v. bolus and will be followed by an infusion of 0.113g. kg-1.h-1 i.v. for 48 hours (therapeutic dose). After the first 48h, a maintenance dose will be administered corresponding to 50% of the therapeutic dose (0.057g. kg-1.h-1 i.v.). Drug administration will stop after successful weaning or end of follow up (maximum 30 days). Comparator: Placebo with composition and dosage identical apart from the active substance. MAIN OUTCOMES The primary outcome assessed in the present study will be the percentage of patients successfully weaned after 30 days of follow-up. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours. RANDOMISATION An allocation sequence to one of the groups will be prepared by the Sponsor of the study. A 1:1 treatment allocation will be adopted. An electronic CRF will be used incorporating IWRS in order to assure proper randomization and unblinding in emergency cases. The representative of the sponsor will get a copy of randomization codes. The information of the randomization codes will then be locked in the database until the time at which an interim analysis or final analysis is performed. BLINDING (MASKING) Participants, caregivers, and all investigators assessing the outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The sample size of 60 patients (that indicates 30 subjects for each group) will have 84% power to detect the estimated difference between the two study groups. The criterion for significance (alpha) has been set at 0.05 and the test is 2-tailed. TRIAL STATUS Protocol number T3inj-02/ThySupport, version 03, May 11, 2020. The trial is not recruiting yet. The trial will start recruitment June 18 th 2020. Estimated recruitment will finish June 18 th , 2021. TRIAL REGISTRATION Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support), ClinicalTrials.gov Identifier: NCT04348513, date of trial registration: April 16, 2020, EudraCT Identifier: 2020-001623-13, date of trial registration: April 22, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Emerging experimental and clinical evidence reveals an evolutionary conserved action of thyroid hormone (TH) to adapt injured tissue to hypoxic conditions via its action on p38 MAPK, Akt signaling pathways.","['Critically Ill Patients With COVID-19 Infection (Thy-Support', 'Participants will start to be recruited from the ICU center of ""ATTIKO"" University Hospital in Greece', 'critically ill COVID-19 infected patients requiring mechanical respiratory support or Extra Corporeal Membrane Oxygenation (ECMO', 'Male and female patients aged over 18 years old who are diagnosed with pulmonary infection due to COVID-19, admitted to Intensive Care Unit and requiring mechanical ventilation or ECMO will be enrolled in this trial', 'Patients will be excluded in cases of pregnancy, severe systemic disease with life expectancy less than 6 months, participation in another trial of an investigational drug or device, corticosteroid and/or sympathomimetic use before initiation of treatment', 'critically ill patients with COVID-19 infection', 'Protocol number T3inj-02/ThySupport, version 03, May 11, 2020']","['Placebo', 'Comparator', 'triiodothyronine (T3', 'Triiodothyronine', 'placebo']",['efficacy and safety'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039052', 'cui_str': 'Sympathomimetic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.495902,"Emerging experimental and clinical evidence reveals an evolutionary conserved action of thyroid hormone (TH) to adapt injured tissue to hypoxic conditions via its action on p38 MAPK, Akt signaling pathways.","[{'ForeName': 'Constantinos', 'Initials': 'C', 'LastName': 'Pantos', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece. cpantos@med.uoa.gr.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Kostopanagiotou', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Armaganidis', 'Affiliation': '2nd Department of Critical Care, ""Attikon"" University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Trikas', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}, {'ForeName': 'Ioulia', 'Initials': 'I', 'LastName': 'Tseti', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}, {'ForeName': 'Iordanis', 'Initials': 'I', 'LastName': 'Mourouzis', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}]",Trials,['10.1186/s13063-020-04474-0'] 2976,32586643,Axial or Helical? CT imaging of the thorax for dyspnoea patients with free-breathing using 16 cm wide-detector CT.,"AIM To compare image quality and radiation dose between fast-helical mode (FHM) and two-axial mode (TAM) in chest computed tomography (CT) with 16 cm wide-detector for emergency patients with dyspnoea. MATERIALS AND METHODS Ninety-six emergency chest CT patients who cannot comply with breathing instructions were prospectively divided randomly into two groups: the FHM group (n=48, helical scan with 80 mm collimation and pitch 0.992:1), the TAM group (n=48, two axial scans with 160 mm collimation). Both groups used 0.28 seconds rotation speed and automatic tube current modulation. All scans were performed in free breathing. CT value, image noise, and signal-to-noise ratio (SNR) were measured on the descending thoracic aorta, lung parenchyma, and paraspinal muscle at the carina level. Two radiologists assessed images for subjective image quality, motion artefacts and diagnostic confidence. The volume CT dose index and dose-length product (DLP) were evaluated and effective dose (ED) was calculated. RESULTS The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05). TAM resulted in 24% lower DLP (96.76±31.58 versus 126.99±33.37 mGy·cm) and ED (1.36±0.44 versus 1.78±0.47 mSv) than FHM (p<0.001), but there was no difference in the CT value, image noise, and SNR between the two groups (p>0.05). CONCLUSIONS TAM with 16 cm detector coverage further reduces the exposure time in chest CT for dyspnoea patients and ensures good image quality with 24% radiation dose reduction, compared with fast-helical chest CT with 80 mm collimation.",2020,"The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05).","['emergency patients with dyspnoea', 'Ninety-six emergency chest CT patients who cannot comply with breathing instructions', 'dyspnoea patients with free-breathing using 16 cm wide-detector CT']","['FHM group (n=48, helical scan with 80 mm collimation and pitch 0.992:1), the TAM', 'fast-helical mode (FHM) and two-axial mode (TAM', 'FHM', 'TAM']","['exposure time', 'CT value, image noise, and SNR', 'subjective image quality, motion artefacts and diagnostic confidence', 'DLP', 'frequency of motion artefacts', 'CT value, image noise, and signal-to-noise ratio (SNR', 'volume CT dose index and dose-length product (DLP', 'diagnostic confidence score']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0454169', 'cui_str': 'Collimator'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0205131', 'cui_str': 'Axial'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.0240973,"The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'GE Healthcare, Computed Tomography Research Center, Beijing, 100176, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China. Electronic address: yj1118@mail.xjtu.edu.cn.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China. Electronic address: xjyjsz@163.com.""}]",Clinical radiology,['10.1016/j.crad.2020.05.014'] 2977,32586693,"Peer Companionship for Mental Health of Older Adults in Primary Care: A Pragmatic, Nonblinded, Parallel-Group, Randomized Controlled Trial.","OBJECTIVES To determine whether peer companionship delivered by an aging services agency to socially-disconnected older adult primary care patients was associated with improvement in suicidal ideation depression, anxiety, and psychological connectedness. DESIGN Pragmatic, nonblinded, parallel-group, randomized controlled trial comparing peer companionship, The Senior Connection (TSC), to care-as-usual (CAU). SETTING Lifespan, a nonmedical, community-based aging services agency. PARTICIPANTS Adult primary care patients ages 60 years or older who endorsed feelings of loneliness or being a burden on others. INTERVENTION TSC was delivered by Lifespan volunteers who provided supportive visits and phone calls in the subjects' homes. CAU involved no peer companion assignment. MEASUREMENTS The primary outcome was suicidal ideation assessed by the Geriatric Suicide Ideation Scale; secondary outcomes were depression, anxiety, and feelings of belonging and being a burden on others. Data were collected at baseline, 3-, 6-, and 12-months. RESULTS Subjects (55% female) had a mean age of 71 years. There was no difference between groups in change in suicidal ideation or belonging. Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01). CONCLUSIONS TSC was superior to CAU for improving depression, anxiety, and perceived burden, but not suicidal ideation. Although effect sizes were small, the low-cost and nationwide availability of peer companionship justify further examination of its effectiveness and scalability in improving mental health outcomes of socially disconnected older adults.",2020,"Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01). ","['socially disconnected older adults', 'Adult primary care patients ages 60 years or older who endorsed feelings of loneliness or being a burden on others', 'Older Adults in Primary Care', 'Subjects (55% female) had a mean age of 71 years', 'Lifespan, a nonmedical, community-based aging services agency', 'to socially-disconnected older adult primary care patients']","['TSC', 'Peer Companionship', 'peer companionship delivered by an aging services agency', 'TSC was delivered by Lifespan volunteers who provided supportive visits and phone calls', 'CAU', 'peer companionship, The Senior Connection (TSC), to care-as-usual (CAU']","['depression, anxiety, and perceived burden', 'anxiety', 'suicidal ideation assessed by the Geriatric Suicide Ideation Scale; secondary outcomes were depression, anxiety, and feelings of belonging and being a burden on others', 'mental health outcomes', 'suicidal ideation', 'suicidal ideation depression, anxiety, and psychological connectedness', 'depression']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.118022,"Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01). ","[{'ForeName': 'Yeates', 'Initials': 'Y', 'LastName': 'Conwell', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY. Electronic address: yeates_conwell@urmc.rochester.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Van Orden', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stone', 'Affiliation': 'Division of Injury Prevention (DMS, WLKWM), Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Wendy LiKamWa', 'Initials': 'WL', 'LastName': 'McIntosh', 'Affiliation': 'Division of Injury Prevention (DMS, WLKWM), Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Messing', 'Affiliation': 'Department of Biostatistics and Computational Biology (SM, KAK), University of Rochester School of Medicine, NY.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Rowe', 'Affiliation': 'Lifespan of Greater Rochester, Inc. (JR), NY.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Podgorski', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Kaukeinen', 'Affiliation': 'Department of Biostatistics and Computational Biology (SM, KAK), University of Rochester School of Medicine, NY.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tu', 'Affiliation': 'Department of Family Medicine and Public Health, Division of Biostatistics and Bioinformatics (XT), UC San Diego School of Medicine, La Jolla, CA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.021'] 2978,32586702,Impact of Interface Type on Noninvasive Ventilation Efficacy in Patients With Neuromuscular Disease: A Randomized Cross-Over Trial.,"BACKGROUND AND OBJECTIVE Around 25% of patients with neuro-muscular diseases (NMD) are treated by home noninvasive ventilation (NIV) through an oronasal mask. However, there is growing evidence that nasal masks require lower NIV pressures and result in fewer residual obstructive events. We hypothesized that nasal masks would improve efficacy and reduce side effects compared to oronasal masks in this population. METHODS open label, cross-over, randomized, study in 2 tertiary care hospitals. Patients with NMD treated by home NIV were randomized for one-week periods to nasal and oronasal interfaces respectively (cross-over). At the end of each period, nocturnal polygraphy (monitoring mouth opening) under NIV, synchronized with transcutaneous partial pressure in CO 2 (tcCO 2 ) was performed. Data were collected from the NIV built-in software and NIV side-effects were collected. Intention-to-treat and per protocol analyses were performed. The primary outcome was mean nocturnal SpO 2 . The secondary outcomes were: percentage of sleep with SpO 2 <90%, oxygen desaturation index (ODI), mean tcCO 2 , mean duration of mouth opening during sleep, level of non-intentional leaks and side-effects. RESULTS Thirty patients with NMD were included. There were no between-group differences for either the primary or secondary outcomes. Post hoc comparisons showed that changing between interfaces reduced NIV efficacy: mean nocturnal SpO 2 (p=0.04), ODI (p=0.01), mean tcCO2 (p=0.048), side-effects (p=0.008). CONCLUSION Nasal masks did not improve NIV efficacy or reduce side effects compared to oronasal masks in patients with NMD treated by home NIV. The efficacy of NIV is reduced during the transition to another interface, requiring close monitoring. Registration number: NCT03458507.",2020,"Post hoc comparisons showed that changing between interfaces reduced NIV efficacy: mean nocturnal SpO 2 (p=0.04), ODI (p=0.01), mean tcCO2 (p=0.048), side-effects (p=0.008). ","['open label, cross-over, randomized, study in 2 tertiary care hospitals', 'Thirty patients with NMD were included', 'Patients With Neuromuscular Disease', 'patients with NMD treated by home NIV', 'Patients with NMD treated by home NIV', 'patients with neuro-muscular diseases (NMD']","['Interface Type', 'home noninvasive ventilation (NIV) through an oronasal mask']","['mean nocturnal SpO 2 ', 'NIV efficacy: mean nocturnal SpO 2', 'percentage of sleep with SpO 2 <90%, oxygen desaturation index (ODI), mean tcCO 2 , mean duration of mouth opening during sleep, level of non-intentional leaks and side-effects', 'NIV efficacy', 'mean tcCO2', 'side-effects', 'Noninvasive Ventilation Efficacy', 'ODI', 'side effects']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.0931772,"Post hoc comparisons showed that changing between interfaces reduced NIV efficacy: mean nocturnal SpO 2 (p=0.04), ODI (p=0.01), mean tcCO2 (p=0.048), side-effects (p=0.008). ","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Léotard', 'Affiliation': 'Département de physiologie, explorations fonctionnelles, unité des pathologies du sommeil, AP-HP, Hôpital Raymond Poincaré, 104, boulevard Raymond-Poincaré, 92380 Garches, France; Université Versailles - Saint-Quentin-en-Yvelines, «End:icap» U1179 Inserm, UFR Des sciences de la sante - Simone-Veil, Versailles, France. Electronic address: antoine.leotard@aphp.fr.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Lebret', 'Affiliation': 'University Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France; AGIR à dom. Association, Meylan F-38240, France.'}, {'ForeName': 'Najeh', 'Initials': 'N', 'LastName': 'Daabek', 'Affiliation': 'AGIR à dom. Association, Meylan F-38240, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Prigent', 'Affiliation': 'Département de physiologie, explorations fonctionnelles, unité de physiologie respiratoire, AP-HP, Hôpital Raymond Poincaré, 104, boulevard Raymond-Poincaré, 92380 Garches, France; Université Versailles - Saint-Quentin-en-Yvelines, «End:icap» U1179 Inserm, UFR Des sciences de la sante - Simone-Veil, Versailles, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Destors', 'Affiliation': 'University Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France; Laboratoire Sommeil et exercice, pole thorax-vaisseaux, CHU Grenoble Alpes, France.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Saint-Raymond', 'Affiliation': 'Unité de pneumologie, CHU Grenoble Alpes, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Sagniez', 'Affiliation': 'Adep Assistance, Le Narval A1 - 29 rue des Hautes Pâtures, 92000 Nanterre, France.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Leroux', 'Affiliation': 'ASV Santé, 125, Avenue Louis Roche, 92230 Gennevilliers, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'University Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France; Laboratoire Sommeil et exercice, pole thorax-vaisseaux, CHU Grenoble Alpes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lofaso', 'Affiliation': 'Département de physiologie, explorations fonctionnelles, unité de physiologie respiratoire, AP-HP, Hôpital Raymond Poincaré, 104, boulevard Raymond-Poincaré, 92380 Garches, France; Université Versailles - Saint-Quentin-en-Yvelines, «End:icap» U1179 Inserm, UFR Des sciences de la sante - Simone-Veil, Versailles, France.'}, {'ForeName': 'Jean Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'University Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France; Laboratoire Sommeil et exercice, pole thorax-vaisseaux, CHU Grenoble Alpes, France.'}, {'ForeName': 'Jean Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'University Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France; AGIR à dom. Association, Meylan F-38240, France.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.05.024'] 2979,32586736,Tezacaftor/ivacaftor in people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events.,"BACKGROUND Increased rates of respiratory adverse events have been observed in people ≥12 years of age with cystic fibrosis homozygous for the Phe508del-CFTR mutation treated with lumacaftor/ivacaftor, particularly in those with percent predicted forced expiratory volume in 1 s (ppFEV 1 ) of <40%. We evaluated the safety, tolerability, and efficacy of tezacaftor/ivacaftor in people with cystic fibrosis homozygous for Phe508del-CFTR who discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms. METHODS Participants ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1 of ≥25% and ≤90% were randomized 1:1 and treated with tezacaftor/ivacaftor or placebo for 56 days. RESULTS Of 97 participants, 94 (96.9%) completed the study. The primary endpoint was incidence of predefined respiratory adverse events of special interest (chest discomfort, dyspnea, respiration abnormal, asthma, bronchial hyperreactivity, bronchospasm, and wheezing): tezacaftor/ivacaftor, 14.0%; placebo, 21.3%. The adverse events were mild or moderate in severity. None were serious or led to treatment interruption or discontinuation. Overall, the discontinuation rate was similar between groups. The mean (SD) ppFEV 1 at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo. The posterior mean difference in absolute change in ppFEV 1 from baseline to the average value of days 28 and 56 was 2.7 percentage points with tezacaftor/ivacaftor vs placebo. CONCLUSIONS Tezacaftor/ivacaftor was generally safe, well tolerated, and efficacious in people ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1 of ≥25% and ≤90% who previously discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms.",2020,ppFEV 1 at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo.,"['Of 97 participants, 94 (96.9%) completed the study', 'people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events', 'people ≥12 years of age with cystic fibrosis homozygous for the Phe508del-CFTR mutation treated with', 'people ≥12 years of age with cystic fibrosis homozygous', 'people with cystic fibrosis homozygous for Phe508del-CFTR who discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms', 'Participants ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1 of ≥25% and ≤90']","['tezacaftor/ivacaftor or placebo', 'tezacaftor/ivacaftor', 'Tezacaftor/ivacaftor', 'lumacaftor/ivacaftor', 'placebo']","['safe, well tolerated, and efficacious', 'discontinuation rate', 'mean (SD', 'adverse events', 'incidence of predefined respiratory adverse events of special interest (chest discomfort, dyspnea, respiration abnormal, asthma, bronchial hyperreactivity, bronchospasm, and wheezing): tezacaftor/ivacaftor', 'safety, tolerability, and efficacy']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0085129', 'cui_str': 'Bronchial hyperreactivity'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",97.0,0.134808,ppFEV 1 at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo.,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwarz', 'Affiliation': 'Christiane Herzog Zentrum Berlin/Charité-Universitätsmedizin Berlin, Berlin, Germany. Electronic address: carsten.schwarz@charite.de.'}, {'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': 'Division of Cystic Fibrosis, Department of Pulmonary Medicine, Faculty of Medicine, Universitat Duisburg Essen-Ruhrlandklinik, Essen, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Epaud', 'Affiliation': 'Cystic Fibrosis and Rare Lung Disease Centre, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Ross C', 'Initials': 'RC', 'LastName': 'Klingsberg', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'Pneumologische Praxis München-Pasing, Munich, Germany.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Audhya', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ferro', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Duncan', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Bote G', 'Initials': 'BG', 'LastName': 'Bruinsma', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.06.001'] 2980,32586939,Clinical significance of circulating tumor cells in hormone receptor-positive metastatic breast cancer patients who received letrozole with or without bevacizumab.,"PURPOSE We evaluated the prognostic and predictive value of circulating tumor cells (CTCs) hormone-receptor positive (HR+) metastatic breast cancer (MBC) patients randomized to letrozole (Let) alone or letrozole plus bevacizumab (Let+Bev) in the first-line setting (CALGB 40503). EXPERIMENTAL DESIGN Blood samples were collected at pretreatment and three additional time points during therapy. The presence of ≥5 CTCs per 7.5 mLs of blood was considered CTC-positive. Association of CTCs with progression-free survival (PFS) and overall survival (OS) was assessed using Cox regression models. RESULTS Of 343 patients treated, 294 had CTC data and were included in this analysis. Median follow-up was 39 months. In multivariable analysis, CTC-positive patients at baseline (31%) had significantly reduced PFS (HR=1.49; 95%CI: 1.12-1.97) and OS (HR=2.08; 95%CI: 1.49-2.93) compared to CTC-negative. Failure to clear CTCs during treatment was associated with significantly increased risk of progression (HR=2.2; 95%CI: 1.58-3.07) and death (HR=3.4; 95% CI: 2.36-4.88). CTC-positive patients who received only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40). Median PFS in CTC-positive patients was significantly longer (18.0 versus 7.0 months) in Let+Bev versus Let arm (p=0.0009). Restricted mean survival time analysis further revealed that addition of Bev was associated with PFS benefit in both CTC-positive and CTC-negative patients, but OS benefit was only observed in CTC-positive patients. CONCLUSIONS CTCs were highly prognostic for the addition of Bev to first-line Let in patients with HR+ MBC. Further research to determine the potential predictive value of CTCs in this setting is warranted.",2020,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"['hormone receptor-positive metastatic breast cancer patients who received', 'CTC-positive patients who received', '343 patients treated, 294 had CTC data and were included in this analysis', 'patients with HR+ MBC']","['letrozole with or without bevacizumab', 'letrozole (Let) alone or letrozole plus bevacizumab (Let+Bev']","['OS benefit', 'Median PFS', 'PFS', 'death', 'Association of CTCs with progression-free survival (PFS) and overall survival (OS', 'risk of progression', 'worse PFS']","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.146634,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"[{'ForeName': 'Mark Jesus M', 'Initials': 'MJM', 'LastName': 'Magbanua', 'Affiliation': 'Laboratory Medicine, University of California, San Francisco Mark.Magbanua@ucsf.edu.'}, {'ForeName': 'Oleksander', 'Initials': 'O', 'LastName': 'Savenkov', 'Affiliation': 'Department of Biostatistics and Epidemiology, Weill Cornell Medicine.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Asmus', 'Affiliation': 'Health Sciences Research, Mayo Clinic.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ballman', 'Affiliation': 'Population Health Sciences, Weill Cornell Medicine.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Scott', 'Affiliation': 'Hematology Oncology, University of California, San Francisco.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Hematology/Oncology, University of California, San Francisco.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Dickler', 'Affiliation': 'Eli Lilly.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Harvard Medical School.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'Medicine, University of North Carolina School of Medicine.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana Farber Harvard Cancer Center.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1329'] 2981,32587084,Improving surgical antibiotic prophylaxis adherence and reducing hospital readmissions: a bundle of interventions including health information technologies.,"OBJECTIVES Infection following orthopaedic surgery is a feared complication and an indicator of the quality of the hospital. Surgical antibiotic prophylaxis (SAP) guidelines are not always properly followed. Our aim was to describe and evaluate the impact of a multidisciplinary intervention on antibiotic prophylaxis adherence to hospital guidelines and 30-day postoperative outcomes. METHODS The study was carried out from January to May 2016 and consisted of creating a multidisciplinary team, updating institutional guidelines and embedding the recommendations in the computerised physician order entry system which is linked to dose and renal function alerts, educational activities and pharmaceutical bedside care of patients in the orthopaedic department. A prospective pre-post study was carried out in accordance with the Declaration of Helsinki. The following information was recorded: patient and surgery characteristics, adherence to SAP guidelines, surgical site infections, length of hospital stay and rate of readmission 30 days after discharge. Statistical analyses were performed using SPSS 18.0. RESULTS Eighty three orthopaedic patients of mean±SD age 68.2±17.0 years (44.6% male, 40 in the pre-intervention group and 43 in the intervention group) were included. Cefazolin was the recommended and most commonly administered antibiotic agent. In the intervention group, an improvement in global adherence to guidelines was achieved (76.7% vs 89.9%; p=0.039): antibiotic duration (75.0% vs 97.7%), correct dosage post-surgery (55.0% vs 76.7%), timing of administration (57.5% vs 72.1%), antibiotic pre-surgery prescription (92.5% vs 97.7%). Three surgical site infections were detected in the pre-intervention group and none in the intervention group (p>0.05). Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038). CONCLUSIONS SAP is used in daily practice in most orthopaedic patients. The implementation of a multidisciplinary programme based on health technology improved the adherence to guidelines and appeared to reduce the readmission rate.",2020,"Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038). ","['68.2±17.0\u2009years (44.6% male, 40 in the pre-intervention group and 43 in the intervention group) were included', 'most orthopaedic patients', 'Eighty', 'three orthopaedic patients of mean±SD age']","['multidisciplinary intervention', 'Surgical antibiotic prophylaxis (SAP', 'Cefazolin']","['readmission', 'patient and surgery characteristics, adherence to SAP guidelines, surgical site infections, length of hospital stay and rate of readmission 30\u2009days after discharge', 'readmission rate', 'Length of hospital stay', 'correct dosage post-surgery', 'global adherence to guidelines', 'antibiotic duration', 'hospital readmissions', 'antibiotic pre-surgery prescription', 'surgical site infections']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",83.0,0.0866826,"Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038). ","[{'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Ribed', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Monje', 'Affiliation': 'Pharmacy Department Hospital, Universitario Del Henares, Coslada, Spain.'}, {'ForeName': 'Xandra', 'Initials': 'X', 'LastName': 'García-González', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Sanchez-Somolinos', 'Affiliation': 'Microbiology and Infectious Diseases Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Sanz-Ruiz', 'Affiliation': 'Orthopaedic Surgery Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Carmen Guadalupe', 'Initials': 'CG', 'LastName': 'Rodríguez-González', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Sanjurjo-Saez', 'Affiliation': 'Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}]",European journal of hospital pharmacy : science and practice,['10.1136/ejhpharm-2018-001666'] 2982,32587333,Author Correction: Low-molecular-weight-heparin increases Th1- and Th17-associated chemokine levels during pregnancy in women with unexplained recurrent pregnancy loss: a randomised controlled trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['women with unexplained recurrent pregnancy loss'],[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}]",[],[],,0.173116,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'E Rasmark', 'Initials': 'ER', 'LastName': 'Roepke', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö and Lund University, Lund, Sweden. emma_36@hotmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bruno', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nedstrand', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boij', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C Petersson', 'Initials': 'CP', 'LastName': 'Strid', 'Affiliation': 'Departmen of Obstetrics and Gynecology, Kalmar Hospital, Kalmar, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piccione', 'Affiliation': 'Section of Gynecology and Obstetrics, Academic Department of Biomedicine and Prevention, and Clinical Department of Surgery, Tor Vergata University Hospital, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Svensson-Arvelund', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-020-67807-8'] 2983,32587371,Author Correction: A Randomised Controlled Trial on the Effectiveness and Adherence of Modified Alternate-day Calorie Restriction in Improving Activity of Non-Alcoholic Fatty Liver Disease.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"['Author Correction', 'Non-Alcoholic Fatty Liver Disease']",['Modified Alternate-day Calorie Restriction'],[],"[{'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",[],,0.0995565,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Muhammad Izzad', 'Initials': 'MI', 'LastName': 'Johari', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairiah', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Juhara', 'Initials': 'J', 'LastName': 'Haron', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Chandran', 'Initials': 'C', 'LastName': 'Nadarajan', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairun Nisah', 'Initials': 'KN', 'LastName': 'Ibrahim', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Muhammad Ilham Abdul', 'Initials': 'MIA', 'LastName': 'Hafidz', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Bee Eng', 'Initials': 'BE', 'LastName': 'Chua', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Nurhazwani', 'Initials': 'N', 'LastName': 'Hamid', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Wan Nor', 'Initials': 'WN', 'LastName': 'Arifin', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia. yylee@usm.my.'}]",Scientific reports,['10.1038/s41598-020-67806-9'] 2984,32587397,The effect of 17% EDTA and QMiX ultrasonic activation on smear layer removal and sealer penetration: ex vivo study.,"This study aimed to compare the effect of conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX on the maximum depth and percentage of sealer penetration into the dentinal tubules by confocal laser scanning microscopy (CLSM) and to describe the cleaning of root canal walls by scanning electron microscopy (SEM). Eighty single-rooted human mandibular premolars were instrumented and randomly assigned to four groups (n = 20): EDTA + CI, QMiX + CI, EDTA + PUI, and QMiX + PUI. Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM (10×). Images were assessed at distances of 2 mm (apical), 5 mm (middle), and 8 mm (coronal) from the apex with the Leica Application Suite V4.10 software. The EDTA + PUI and QMiX + PUI protocols presented higher rates of debris/smear layer removal in the apical and middle thirds. The PUI was superior to CI in the maximum depth of sealer penetration at the middle third. The QMiX + PUI group had a higher percentage of sealer penetration at the apical third. The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.",2020,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"['Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a', 'Eighty single-rooted human mandibular premolars']","['conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX', '17% EDTA and QMiX ultrasonic activation', 'single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM']","['sealer penetration', 'rates of debris/smear layer removal', 'debris/smear layer removal and tubular dentin sealer penetration']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440200', 'cui_str': 'Gutta percha cone'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0073194', 'cui_str': 'Rhodamine B'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",80.0,0.0357585,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"[{'ForeName': 'Felipe de Souza', 'Initials': 'FS', 'LastName': 'Matos', 'Affiliation': 'Postgraduate Program in Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil. felipe_smatos@hotmail.com.'}, {'ForeName': 'Fabrício Rutz', 'Initials': 'FR', 'LastName': 'da Silva', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa (UEPG), Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Luiz Renato', 'Initials': 'LR', 'LastName': 'Paranhos', 'Affiliation': 'Department of Preventive and Social Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Camilla Christian Gomes', 'Initials': 'CCG', 'LastName': 'Moura', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}, {'ForeName': 'Marcia Carneiro', 'Initials': 'MC', 'LastName': 'Valera', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-67303-z'] 2985,32592414,The effect of a solution-oriented approach in depressive patients on social functioning levels and suicide probability.,"PURPOSE This study was conducted to evaluate the effect of a solution-oriented approach in depressive patients on suicide probability and the social functioning level. DESIGN AND METHOD The research was designed as a randomized controlled trial with a pretest and posttest control group and repeated measures. A Solution-Oriented Approach Intervention (SOAI) was performed for a total of 6 to 10 sessions with the experimental group. FINDINGS The SOAI in depressive patients effectively increased the social functioning level and decreased suicide probability. PRACTICE IMPLICATIONS The SOAI in depressive patients should be implemented by psychiatric nurses within the scope of psychiatric care services.",2020,"The SOAI in depressive patients effectively increased the social functioning level and decreased suicide probability. ","['depressive patients on suicide probability and the social functioning level', 'depressive patients on social functioning levels and suicide probability']","['solution-oriented approach', 'A Solution-Oriented Approach Intervention (SOAI']",['social functioning level and decreased suicide probability'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0536419,"The SOAI in depressive patients effectively increased the social functioning level and decreased suicide probability. ","[{'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Ayar', 'Affiliation': 'Faculty of Health Sciences, Kilis University, Kilis, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Sabanciogullari', 'Affiliation': 'Department of Psychiatric Nursing, School of Susehri Health High, Cumhuriyet University, Sivas, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12554'] 2986,32592439,Preventing Stress-Related Ill Health Among New Registered Nurses by Supporting Engagement in Proactive Behaviors-A Randomized Controlled Trial.,"BACKGROUND New registered nurses (RNs) are at risk of developing symptoms of stress-related ill health. OBJECTIVES To evaluate the effect of a 3 × 3 hour group intervention aiming to prevent symptoms of stress-related ill health among new RNs by increasing engagement in proactive behaviors. The intervention involves discussions and models of newcomer experiences and stress and the behavior change techniques reinforcing approach behaviors, systematic exposure, and action planning. DESIGN A randomized parallel group trial with an active control condition. PARTICIPANTS The study sample consisted of 239 new RNs participating in a transition-to-practice program for new RNs in a large county in Sweden. METHODS Participants were randomized to either the experimental intervention or a control intervention. Data on experiences of stress, avoidance of proactive behaviors, engagement in leisure activities, role clarity, task mastery, and social acceptance were collected before and after the intervention. Effects were evaluated using multilevel model analysis and regression analysis. Missing data were imputed using multiple imputation. RESULTS The control group experienced a statistically significant increase in experiences of stress during the period of the study (t(194.13) = 1.98, p = .049), whereas the level in the experimental group remained stable. Greater adherence to the intervention predicted a greater effect on experiences of stress (β = -0.15, p = .039) and social acceptance (β = 0.16, p = .027). LINKING EVIDENCE TO ACTION Transition-to-practice programs may benefit from adding an intervention that specifically addresses new RNs' experiences of stress to further support them as they adjust to their new professional role. However, replication studies with larger samples, more reliable measures, and longer periods of follow-up are needed.",2020,"Greater adherence to the intervention predicted a greater effect on experiences of stress (β = -0.15, p = .039) and social acceptance (β = 0.16, p = .027). ","['The study sample consisted of 239 new RNs participating in a transition-to-practice program for new RNs in a large county in Sweden', 'Participants']",['control intervention'],"['experiences of stress', 'stress, avoidance of proactive behaviors, engagement in leisure activities, role clarity, task mastery, and social acceptance', 'social acceptance']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0564245,"Greater adherence to the intervention predicted a greater effect on experiences of stress (β = -0.15, p = .039) and social acceptance (β = 0.16, p = .027). ","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Frögéli', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Rudman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Gustavsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12442'] 2987,32592450,Impact of lesion preparation strategies on outcomes of left main PCI: The EXCEL trial.,"OBJECTIVES We examined outcomes according to lesion preparation strategy (LPS) in patients with left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the EXCEL trial. BACKGROUND The optimal LPS for LMCA PCI is unclear. METHODS We categorized LPS hierarchically (high to low) as: (a) rotational atherectomy (RA); (b) cutting or scoring balloon (CSB); (c) balloon angioplasty (BAL); and d) direct stenting (DIR). The primary endpoint was 3-year MACE; all-cause death, stroke, or myocardial infarction. RESULTS Among 938 patients undergoing LMCA PCI, RA was performed in 6.0%, CSB 9.5%, BAL 71.3%, and DIR 13.2%. In patients treated with DIR, BAL, CSB, and RA, respectively, there was a progressive increase in SYNTAX score, LMCA complex bifurcation, trifurcation or calcification, number of stents, and total stent length. Any procedural complication occurred in 10.4% of cases overall, with the lowest rate in the DIR (7.4%) and highest in the RA group (16.1%) (p trend = .22). There were no significant differences in the 3-year rates of MACE (from RA to DIR: 17.9%, 20.2%, 14.5%, 14.7%; p = .50) or ischemia-driven revascularization (from RA to DIR: 16.8%, 10.8%, 12.3%, 14.2%; p = .65). The adjusted 3-year rates of MACE did not differ according to LPS. CONCLUSIONS The comparable 3-year outcomes suggest that appropriate lesion preparation may be able to overcome the increased risks of complex LMCA lesion morphology.",2020,The comparable 3-year outcomes suggest that appropriate lesion preparation may be able to overcome the increased risks of complex LMCA lesion morphology.,"['patients with left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the EXCEL trial', '938 patients undergoing']","['LMCA PCI, RA', 'rotational atherectomy (RA); (b) cutting or scoring balloon (CSB); (c) balloon angioplasty (BAL); and d) direct stenting (DIR', 'lesion preparation strategy (LPS']","['3-year MACE; all-cause death, stroke, or myocardial infarction', 'ischemia-driven revascularization', 'adjusted 3-year rates of MACE', '3-year rates of MACE', 'procedural complication', 'SYNTAX score, LMCA complex bifurcation, trifurcation or calcification, number of stents, and total stent length', 'risks of complex LMCA lesion morphology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0162655', 'cui_str': 'Rotational atherectomy'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1261082', 'cui_str': 'Left coronary artery structure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449958', 'cui_str': 'Number of stent(s)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449462', 'cui_str': 'Length of stent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",938.0,0.135588,The comparable 3-year outcomes suggest that appropriate lesion preparation may be able to overcome the increased risks of complex LMCA lesion morphology.,"[{'ForeName': 'Nirat', 'Initials': 'N', 'LastName': 'Beohar', 'Affiliation': 'Columbia University Division of Cardiology at the Mount Sinai Medical Center, Miami Beach, Florida, USA.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Lembo', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Banning', 'Affiliation': 'John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, NUIG, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia, USA.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29116'] 2988,32592481,Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease.,"BACKGROUND We assessed whether differential efficacy of early combined immunosuppression (ECI) in comparison with conventional management (CM) is present in patients with Crohn disease (CD) according to disease location. METHODS In this posthoc analysis of the Randomized Evaluation of an Algorithm for Crohn's Treatment trial, the effect of ECI vs CM modified by disease location (isolated-colonic vs ileal-dominant) in terms of time to first complication (hospitalization, surgery, or disease-related complications-presence of a new abscess, fistula, or stricture; serious worsening of disease activity; extraintestinal manifestations) was analyzed using a marginal Cox proportional hazard model to account for cluster randomization. Factors adjusted included practice size, country, and other covariates selected in a backward logistic regression analysis with the first composition as outcome and P < 0.10. RESULTS Of the 1969 patients with CD, 435 had isolated colonic CD (ECI n = 257, CM n = 178) and 1534 had ileal CD (ECI n = 817, CM n = 717). Over 24 months there was a significant differential impact for ECI vs CM for reducing the risk of a CD-related complication between patients with colonic CD and ileal CD (colonic CD hazard ratio [HR] = 0.51; 95% CI, 0.30-0.85 vs ileal CD HR = 0.79; 95% CI, 0.57-1.10; P = 0.033). No difference was identified between ECI vs CM for reducing the risk of surgery (colonic HR = 0.52 vs ileal HR = 0.74; P = 0.468) or hospitalization (colonic HR = 0.77 vs ileal HR = 0.83; P = 0.806). CONCLUSIONS In this posthoc analysis of the Randomized Evaluation of an Algorithm for Crohn's Treatment trial, symptom-based ECI was associated with greater efficacy for reducing the risk of CD-related complications in patients with colonic disease location relative to ileal disease location.",2020,No difference was identified between ECI vs CM for reducing the risk of surgery (colonic HR = 0.52,"['1969 patients with CD, 435 had isolated colonic CD (ECI n = 257, CM n = 178) and 1534 had ileal CD (ECI n = 817, CM n = 717', 'patients with colonic disease location relative to ileal disease location', 'patients with Crohn disease (CD) according to disease location']","['ECI', 'conventional management (CM', 'Immunosuppression', 'early combined immunosuppression (ECI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0009373', 'cui_str': 'Disorder of colon'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020875', 'cui_str': 'Ileal Diseases'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.071335,No difference was identified between ECI vs CM for reducing the risk of surgery (colonic HR = 0.52,"[{'ForeName': 'Parambir S', 'Initials': 'PS', 'LastName': 'Dulai', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Guangyong', 'Initials': 'G', 'LastName': 'Zou', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Stitt', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa168'] 2989,31436452,Distraction at the cocktail party: Attenuation of the irrelevant speech effect after a training of auditory selective attention.,"Task-irrelevant auditory stimuli such as speech are known to disrupt the retention of serial information held in verbal short-term memory (STM). Although such effects of irrelevant sound are typically very robust, there is evidence suggesting that some forms of auditory distraction are susceptible to cognitive control or auditory attention. In the present study, we tested whether an extensive training of auditory selective attention reduces the degree of interference produced by irrelevant speech in a serial STM task. Participants (n = 38) were trained on an adaptive dichotic-listening task requiring selective processing of a varying list of verbal items presented via headphones while ignoring auditory distractors presented simultaneously either by a different voice or in the irrelevant ear. The number of target items that could be memorized increased throughout 5 training sessions, suggesting improvement of auditory selective attention in a dichotic-listening situation. An active control group (n = 37) was trained on an auditory duration discrimination task for 5 sessions. Prior to the training, task-irrelevant speech was shown to interfere with serial recall in both groups. After the training, however, the irrelevant speech effect was attenuated in the group that was trained on the dichotic-listening task, whereas no reduction of auditory distraction was observed in the active control group. The results show that the interference produced by task-irrelevant speech can be reduced through an extensive dichotic-listening training, suggesting that the irrelevant speech effect is susceptible to auditory selective attention. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2020,"The number of target items that could be memorized increased throughout 5 training sessions, suggesting improvement of auditory selective attention in a dichotic-listening situation.",['Participants (n = 38'],"['extensive training of auditory selective attention', 'adaptive dichotic-listening task requiring selective processing of a varying list of verbal items presented via headphones while ignoring auditory distractors presented simultaneously either by a different voice or in the irrelevant ear']","['auditory selective attention', 'auditory distraction', 'irrelevant speech effect']",[],"[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",38.0,0.0221096,"The number of target items that could be memorized increased throughout 5 training sessions, suggesting improvement of auditory selective attention in a dichotic-listening situation.","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kattner', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Ellermeier', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Human perception and performance,['10.1037/xhp0000695'] 2990,31544471,Time to First Culture Positivity Among Critically Ill Adults With Methicillin-Resistant Staphylococcus aureus Growth in Respiratory or Blood Cultures.,"Background: For critically ill adults receiving empirical vancomycin, the duration of negative cultures after which vancomycin may be discontinued without risking subsequent growth of methicillin-resistant Staphylococcus aureus (MRSA) remains unknown. Objective: We hypothesized that if sputum cultures did not grow MRSA or blood cultures did not grow Gram-positive cocci on Gram stain by 48 hours, those cultures would not subsequently demonstrate MRSA. Methods: We conducted an ancillary analysis from patients enrolled in the Isotonic Solutions and Major Adverse Renal Events Trial (SMART). In this cohort of patients, we collected data on the time of either MRSA identification in culture or Gram-positive cocci identification on Gram stain and rate of vancomycin discontinuation. Results: Of the 15 802 patient admissions in the SMART study, 6553 (41.5%) received empirical intravenous vancomycin. Respiratory sputum cultures demonstrated MRSA during 178 patient admissions. Among respiratory cultures that would ultimately grow MRSA, 85% were positive within 48 hours, and 97% were positive within 72 hours. Cultures demonstrated MRSA bacteremia during 85 patient admissions. In 83 cases (97.6%) of MRSA bacteremia, Gram-positive cocci were identified within 48 hours after the culture was obtained. Conclusion and Relevance: This analysis of a large cohort of critically ill adults receiving empirical vancomycin found that Staphylococcus aureus was present in all but 15% of cases of MRSA-positive respiratory cultures after 48 hours, whereas Gram-positive cocci were identified within 48 hours during nearly all episodes of MRSA bacteremia. These findings may inform the timing of discontinuation of empirical vancomycin among critically ill adults.",2020,"In 83 cases (97.6%) of MRSA bacteremia, Gram-positive cocci were identified within 48 hours after the culture was obtained. ","['patients enrolled in the Isotonic Solutions and Major Adverse Renal Events Trial (SMART', '15\u2009802 patient admissions in the SMART study, 6553 (41.5%) received', 'critically ill adults', '178 patient admissions', 'critically ill adults receiving empirical']","['empirical intravenous vancomycin', 'vancomycin']","['MRSA bacteremia', 'MRSA bacteremia, Gram-positive cocci', 'Time to First Culture Positivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0030673', 'cui_str': 'Patient Admission'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C4040349', 'cui_str': 'Bacteremia due to Methicillin resistant Staphylococcus aureus'}, {'cui': 'C0018155', 'cui_str': 'Gram-positive coccus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",85.0,0.201161,"In 83 cases (97.6%) of MRSA bacteremia, Gram-positive cocci were identified within 48 hours after the culture was obtained. ","[{'ForeName': 'Paige A', 'Initials': 'PA', 'LastName': 'Melling', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Noto', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Stollings', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}]",The Annals of pharmacotherapy,['10.1177/1060028019877937'] 2991,32591498,"A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression.","The strategy of repeated ketamine in open-label and saline-control studies of treatment-resistant depression suggested greater antidepressant response beyond a single ketamine. However, consensus guideline stated the lack of evidence to support frequent ketamine administration. We compared the efficacy and safety of single vs. six repeated ketamine using midazolam as active placebo. Subjects received either six ketamine or five midazolam followed by a single ketamine during 12 days followed by up to 6-month post-treatment period. The primary end point was the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at 24 h after the last infusion. Fifty-four subjects completed all six infusions. For the primary outcome measure, there was no significant difference in change of MADRS scores between six ketamine group and single ketamine group at 24 h post-last infusion. Repeated ketamine showed greater antidepressant efficacy compared to midazolam after five infusions before receiving single ketamine infusion. Remission and response favored the six ketamine after infusion 4 and 5, respectively, compared to midazolam before receiving single ketamine infusion. For those who responded, the median time-to-relapse was nominally but not statistically different (2 and 6 weeks for the single and six ketamine group, respectively). Repeated infusions were relatively well-tolerated. Repeated ketamine showed greater antidepressant efficacy to midazolam after five infusions but fell short of significance when compared to add-on single ketamine to midazolam at the end of 2 weeks. Increasing knowledge on the mechanism of ketamine should drive future studies on the optimal balance of dosing ketamine for maximum antidepressant efficacy with minimum exposure.",2020,"For the primary outcome measure, there was no significant difference in change of MADRS scores between six ketamine group and single ketamine group at 24 h post-last infusion.",[],"['subanesthetic ketamine', 'six ketamine or five midazolam', 'ketamine', 'active placebo', 'midazolam', 'placebo']","['median time-to-relapse', 'Remission and response', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'efficacy and safety', 'antidepressant efficacy', 'change of MADRS scores', 'efficacy, safety, and durability']",[],"[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",54.0,0.202748,"For the primary outcome measure, there was no significant difference in change of MADRS scores between six ketamine group and single ketamine group at 24 h post-last infusion.","[{'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Shiroma', 'Affiliation': 'Geriatric Psychiatrist, Minneapolis VA Health Care System, Mental Health Service Line, Minneapolis, MN, USA. paulo.shiroma@va.gov.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': 'Statistician/Research Methodologist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor/Research Associate, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wels', 'Affiliation': 'Staff Anesthesiologist, Minneapolis VA Health Care System, Mental Health Service Line; and Clinical Instructor, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'C Sophia', 'Initials': 'CS', 'LastName': 'Albott', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Erbes', 'Affiliation': 'Staff Psychologist, Minneapolis VA Health Care System, Mental Health Service Line; and Associate Professor of Psychiatry, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Tye', 'Affiliation': 'Senior Research Fellow, Queensland Brain Institute, The University of Queensland, Queensland, Australia; and Assistant Professor Psychiatry, Psychology and Pharmacology Translational Neuroscience Laboratory, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Drs. T.J. and Ella M. Arneson Land-Grant Chair in Human Behavior, Professor of Psychiatry, Vice Chair for Research Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}]",Translational psychiatry,['10.1038/s41398-020-00897-0'] 2992,32591562,"Effect of palmitoylethanolamide on inner retinal function in glaucoma: a randomized, single blind, crossover, clinical trial by pattern-electroretinogram.","Glaucoma is a neurodegenerative disease, our study aimed to evaluate the potential effects of Palmitoylethanolamide (PEA) supplementation on RGCs function by PERG examination, and to record effects on intraocular pressure, visual field and quality of life. It was a single centre, randomized, prospective, single blind, two treatment, two period crossover study on stable glaucoma patients on topical monotherapy comparing current topical therapy alone or additioned with PEA 600 mg one tablet a day. At baseline, at 4 and at 8 months, all patients underwent to complete ophthalmic examination, pattern electroretinogram, visual field, and quality of life evaluation. 40 patients completed the study: mean age 66.6 ± 7.6 years; 21 (52.5%) male; 35 POAG (87.5%). At baseline, most patients had an early visual field defect, the IOP was well controlled. At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed. Our study is the first to show promising effects of PEA on PERG and on quality of life in glaucoma patients.",2020,"At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed.","['40 patients completed the study: mean age 66.6\u2009±\u20097.6\xa0years; 21 (52.5%) male; 35 POAG (87.5', 'stable glaucoma patients on topical monotherapy comparing current', 'glaucoma', 'glaucoma patients']","['PEA', 'topical therapy alone or additioned with PEA 600\xa0mg one tablet a day', 'palmitoylethanolamide', 'Palmitoylethanolamide (PEA) supplementation']","['quality of life', 'higher quality of life scores', 'IOP', 'complete ophthalmic examination, pattern electroretinogram, visual field, and quality of life evaluation', 'intraocular pressure, visual field and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",,0.275603,"At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed.","[{'ForeName': 'Gemma Caterina Maria', 'Initials': 'GCM', 'LastName': 'Rossi', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy. gemma.rossi.md@gmail.com.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': 'Scudeller', 'Affiliation': 'Clinical Epidemiology and Biometric Unit, Scientific Direction, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Lumini', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Bettio', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Picasso', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruberto', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Aba', 'Initials': 'A', 'LastName': 'Briola', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Mirabile', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Paviglianiti', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Pasinetti', 'Affiliation': 'Eye Unit, Istituto Beato Palazzolo, Bergamo, Italy.'}, {'ForeName': 'Paolo Emilio', 'Initials': 'PE', 'LastName': 'Bianchi', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}]",Scientific reports,['10.1038/s41598-020-67527-z'] 2993,32591590,Effects of combining constraint-induced movement therapy and action-observation training on upper limb kinematics in children with unilateral cerebral palsy: a randomized controlled trial.,"Modified constraint-induced movement therapy (mCIMT) improves upper limb (UL) motor execution in unilateral cerebral palsy (uCP). As these children also show motor planning deficits, action-observation training (AOT) might be of additional value. Here, we investigated the combined value of AOT to mCIMT on UL kinematics in children with uCP in a randomized controlled trial. Thirty-six children with uCP completed an UL kinematic and clinical evaluation after participating in a 9-day mCIMT camp wearing a splint for 6 h/day. The experimental group (mCIMT + AOT, n = 20) received 15 h of AOT, i.e. video-observation and execution of unimanual tasks. The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks. We examined changes in motor control (movement duration, peak velocity, time-to-peak velocity, and trajectory straightness) and kinematic movement patterns (using Statistical Parametric Mapping) during the execution of three unimanual, relevant tasks before the intervention, after and at 6 months follow-up. Adding AOT to mCIMT mainly affected movement duration during reaching, whereas little benefit is seen on UL movement patterns. mCIMT, with or without AOT, improved peak velocity and trajectory straightness, and proximal movement patterns. Clinical and kinematic improvements are poorly related. Although there seem to be limited benefits of AOT to CIMT on UL kinematics, our results support the inclusion of kinematics to capture changes in motor control and movement patterns of the proximal joints.",2020,"The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks.","['children with unilateral cerebral palsy', 'children with uCP', 'unilateral cerebral palsy (uCP', 'Thirty-six children with uCP completed an UL kinematic and clinical evaluation after participating in a 9-day mCIMT camp wearing a splint for 6\xa0h/day']","['15\xa0h of AOT, i.e. video-observation and execution of unimanual tasks', 'control group (mCIMT\u2009+\u2009placebo, n\u2009=\u200916) watched biological-motion free videos and executed the same tasks', 'combining constraint-induced movement therapy and action-observation training', 'AOT to mCIMT', 'Modified constraint-induced movement therapy (mCIMT']","['peak velocity and trajectory straightness, and proximal movement patterns', 'motor control (movement duration, peak velocity, time-to-peak velocity, and trajectory straightness) and kinematic movement patterns', 'upper limb kinematics', 'upper limb (UL) motor execution']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}]",36.0,0.0555808,"The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Simon-Martinez', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium. cristina.simon@kuleuven.be.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mailleux', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Jaspers', 'Affiliation': 'Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Ortibus', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Desloovere', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Klingels', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Feys', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}]",Scientific reports,['10.1038/s41598-020-67427-2'] 2994,32591594,Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial.,"Cold atmospheric plasma (CAP) was shown to decrease bacterial load in chronic wounds. It was also presented as a novel approach to healing wounds in both in vitro and in vivo experiments. We aimed to examine the first randomized clinical trial for the use of CAP in diabetic foot ulcers. Patients (n = 44) were randomly double-blinded, and assigned to receive standard care (SC, n = 22) without or with CAP, to be applied three times a week for three consecutive weeks (SC + CAP, n = 22), using block randomization with mixing block sizes of four. The trial was conducted at the Diabetes Research Center in Tehran, Iran. CAP was generated from ionized helium gas in ambient air, and driven by a high voltage (10 kV) and high frequency (6 kHz) power supply. Primary outcomes were wound size, number of cases reaching wound size of <0.5, and a bacterial load after over three weeks of treatment. CAP treatment effectively reduced the fraction of wound size (p = 0.02). After three weeks, the wounds to reach fraction wound size of ≤0.5 was significantly greater in the SC + CAP group (77.3%) compared to the SC group (36.4%) (p = 0.006). The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures. CAP can be an efficient method to accelerate wound healing in diabetic foot ulcers, with immediate antiseptic effects that do not seem to last long.",2020,The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures.,"['Diabetes Research Center in Tehran, Iran', 'diabetic foot ulcers', 'Patients (n\u2009=\u200944']","['Cold atmospheric plasma (CAP', 'Cold atmospheric plasma', 'CAP', 'standard care (SC, n\u2009=\u200922) without or with CAP']","['mean fraction of bacterial load', 'wound size, number of cases reaching wound size of <0.5, and a bacterial load', 'fraction of wound size']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0444500', 'cui_str': '0.5'}]",44.0,0.0759249,The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures.,"[{'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Mirpour', 'Affiliation': 'Department of Applied physics, Eindhoven university of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fathollah', 'Affiliation': 'Department of Applied physics, Amirkabir university of Technology, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mansouri', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran. mansorip@sina.tums.ac.ir.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Larijani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Ghoranneviss', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohajeri Tehrani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. mrmohajeri@tums.ac.ir.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Amini', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. mramini@tums.ac.ir.'}]",Scientific reports,['10.1038/s41598-020-67232-x'] 2995,32591782,Pharmacokinetics of Cannabis Brownies: A Controlled Examination of Δ9-Tetrahydrocannabinol and Metabolites in Blood and Oral Fluid of Healthy Adult Males and Females.,"Oral cannabis products (a.k.a. ""edibles"") have increased in popularity in recent years. Most prior controlled pharmacokinetic evaluations of cannabis have focused on smoked cannabis and included males who were frequent cannabis users. In this study, 17 healthy adults (8 females), with no cannabis use in at least the past two months, completed four double-blind outpatient sessions where they consumed cannabis brownies containing Δ9-tetrahydrocannabinol (THC) doses of 0, 10, 25, or 50 mg. Whole blood and oral fluid specimens were collected at baseline and for 8 h post-brownie ingestion. Enzyme-linked-immunosorbent-assay (ELISA) and liquid chromatography-tandem mass spectrometry (LC-MS-MS) were used to measure THC and relevant metabolites. In whole blood, concentrations of THC and 11-hydroxy-THC (11-OH-THC) peaked 1.5-2 h after brownie consumption, decreased steadily thereafter, and typically returned to baseline within 8 h. Blood concentrations for 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THCCOOH) and THCCOOH-glucuronide, were higher than THC and 11-OH-THC and these metabolites were often still detected 8 h post-brownie consumption. Women displayed higher peak concentrations for THC and all metabolites in whole blood compared to men, at least partially owing to their lower body weight/BMI. Detection of THC in oral fluid was immediate and appeared to reflect the degree of cannabis deposition in the oral cavity, not levels of THC circulating in the blood. THC concentrations were substantially higher in oral fluid than in blood; the opposite trend was observed for THCCOOH. Agreement between ELISA and LC-MS-MS results was high (i.e., over 90%) for blood THCCOOH and oral fluid THC but comparatively low for oral fluid THCCOOH (i.e., 67%). Following oral consumption of cannabis, THC was detected in blood much later, and at far lower peak concentrations, compared to what has been observed with inhaled cannabis. These results are important given the widespread use of toxicological testing to detect recent use of cannabis and/or to identify cannabis intoxication.",2020,"Following oral consumption of cannabis, THC was detected in blood much later, and at far lower peak concentrations, compared to what has been observed with inhaled cannabis.","['smoked cannabis and included males who were frequent cannabis users', '17 healthy adults (8 females), with no cannabis use in at least the past two months', 'Healthy Adult Males and Females', 'Cannabis Brownies']","['Δ9-Tetrahydrocannabinol and Metabolites', 'Enzyme-linked-immunosorbent-assay', 'cannabis brownies containing Δ9-tetrahydrocannabinol (THC']","['concentrations of THC and 11-hydroxy-THC (11-OH-THC', 'blood THCCOOH and oral fluid THC', 'THC concentrations', 'Blood concentrations for 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THCCOOH) and THCCOOH-glucuronide']","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]",17.0,0.0611129,"Following oral consumption of cannabis, THC was detected in blood much later, and at far lower peak concentrations, compared to what has been observed with inhaled cannabis.","[{'ForeName': 'Tory R', 'Initials': 'TR', 'LastName': 'Spindle', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr, Baltimore, MD 21224, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Cone', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr, Baltimore, MD 21224, USA.'}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Herrmann', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr, Baltimore, MD 21224, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., NC 27709, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Flegel', 'Affiliation': 'Substance Abuse and Mental Health Services Administration (SAMHSA), Division of Workplace Programs (DWP), 5600 Fishers Lane, Rockville, MD 20857, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'LoDico', 'Affiliation': 'Substance Abuse and Mental Health Services Administration (SAMHSA), Division of Workplace Programs (DWP), 5600 Fishers Lane, Rockville, MD 20857, USA.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr, Baltimore, MD 21224, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr, Baltimore, MD 21224, USA.'}]",Journal of analytical toxicology,['10.1093/jat/bkaa067'] 2996,32591862,A randomized controlled phase II clinical trial on mRNA electroporated autologous monocyte-derived dendritic cells (TriMixDC-MEL) as adjuvant treatment for stage III/IV melanoma patients who are disease-free following the resection of macrometastases.,"BACKGROUND Autologous monocyte-derived mRNA co-electroporated dendritic cells with mRNA encoding CD40 ligand (CD40L), CD70 and a constitutively activated TLR4 (caTLR4) (referred to as TriMixDC-MEL) have anti-tumor activity in advanced melanoma patients. We investigated the safety and activity of adjuvant TriMixDC-MEL in stage III/IV melanoma patients. MATERIALS AND METHODS Forty-one patients were randomly assigned to treatment with TriMixDC-MEL (n = 21) and standard follow-up (n = 20). ""Cross-over"" was allowed at the time of non-salvageable recurrence. The primary endpoint was the percentage of patients alive and disease-free at 1-year. For a subset of patients, (formalin-fixed paraffin-embedded), tumor tissue samples were available for mRNA expression profiling and PD-L1 immunohistochemical staining. RESULTS Baseline characteristics were well balanced. One-year after randomization, 71% of patients in the study arm were alive and free of disease compared to 35% in the control arm. After a median follow-up of 53 months (range 3-67), 23 patients experienced a non-salvageable melanoma recurrence (TriMixDC-Mel arm n = 9 and control arm n = 14).The median time to non-salvageable recurrence was superior in the TriMixDC-MEL arm (median 8 months (range 1-6) vs. not reached; log-rank p 0.044). TriMixDC-MEL-related adverse events (AE) consisted of transient local skin reactions, flu-like symptoms and post-infusion chills. No grade ≥ 3 AE's occurred. The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers. CONCLUSION TriMixDC-MEL id/iv as adjuvant therapy is tolerable and may improve the 1-year disease-free survival rate. Combination of optimized autologous monocyte-derived DC-formulations warrants further investigation in combination with currently approved adjuvant therapy options.",2020,"The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers. ","['stage III/IV melanoma patients', 'advanced melanoma patients', 'Forty-one patients', 'stage III/IV melanoma patients who are disease-free following the resection of macrometastases']","['adjuvant TriMixDC-MEL', 'mRNA electroporated autologous monocyte-derived dendritic cells (TriMixDC-MEL', 'TriMixDC-MEL']","['median time to non-salvageable recurrence', 'non-salvageable melanoma recurrence', '1-year disease-free survival rate', 'alive and free of disease', 'percentage of patients alive and disease-free at 1-year']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0939937', 'cui_str': 'Honey preparation'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",41.0,0.316794,"The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers. ","[{'ForeName': 'Yanina', 'Initials': 'Y', 'LastName': 'Jansen', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090, Brussels, Belgium. Yanina.jansen@uzbrussel.be.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Kruse', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Corthals', 'Affiliation': 'Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Schats', 'Affiliation': 'Histogenex NV, Antwerp, Belgium.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'van Dam', 'Affiliation': 'Histogenex NV, Antwerp, Belgium.'}, {'ForeName': 'Teofila', 'Initials': 'T', 'LastName': 'Seremet', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Heirman', 'Affiliation': 'Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Brochez', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kockx', 'Affiliation': 'Histogenex NV, Antwerp, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Thielemans', 'Affiliation': 'Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090, Brussels, Belgium.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02618-4'] 2997,32587557,Providing Psychological and Emotional Support After Perinatal Loss: Protocol for a Virtual Reality-Based Intervention.,"The loss of an infant during the perinatal period has been recognized as a complex and potentially traumatic life event and can have a significant impact on women's mental health. However, often times, psychological aftercare is typically not offered, and manualized interventions are rarely used in clinical care practice and have seldom been evaluated. In recent years, a growing number of studies have demonstrated the efficacy of virtual reality (VR) interventions to facilitate the expression and coping with emotions linked to a traumatic event. The objective of the proposed paper is to present the protocol of a randomized control trial aimed to assess a novel VR-based intervention for mothers who experienced a perinatal loss. We hypothesize that the VR-based intervention group will show significantly reduced symptoms related to grief, postnatal depression and general psychopathology after treatment relative to a treatment-as-usual (TAU) group. Participants would be randomly assigned to the TAU + VR or to the VR + TAU condition. The TAU condition as well as the VR-based intervention will last 3 weeks, after which women will complete a post-assessment. The proposed VR-based intervention will consist in three weekly sessions focused, respectively on: (1) collect information about the loss and psychoeducation about perinatal grief, and introduction to the virtual environment; (2) through the use of the virtual environment, women will be assisted in the elaboration and acceptation of loss; (3) recreate, using the specific features of the virtual environment a positive metaphor representing woman's future life. VR has proved to be a valid intervention tool in clinical psychology, and in the last years VR technologies have become more affordable to be used in clinical practice. With the present study we propose to answer to the unquestionable need for interventions addressed to ameliorate the emotional effects in women who experienced perinatal loss, by exploiting also the therapeutic opportunities offered by a new technology as VR.",2020,"We hypothesize that the VR-based intervention group will show significantly reduced symptoms related to grief, postnatal depression and general psychopathology after treatment relative to a treatment-as-usual (TAU) group.",['mothers who experienced a perinatal loss'],"['Virtual Reality-Based Intervention', 'novel VR-based intervention', 'TAU + VR', 'virtual reality (VR) interventions']","['Providing Psychological and Emotional Support', 'grief, postnatal depression and general psychopathology']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.0215846,"We hypothesize that the VR-based intervention group will show significantly reduced symptoms related to grief, postnatal depression and general psychopathology after treatment relative to a treatment-as-usual (TAU) group.","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Corno', 'Affiliation': 'Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Departamento Personalidad, Evaluación y Tratamientos Psicológicos, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Rivard', 'Affiliation': 'Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Verdon', 'Affiliation': 'Département des Sciences Infirmières, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'de Montigny', 'Affiliation': ""Centre de Santé et de Services Sociaux de l'Outaouais, Gatineau, QC, Canada.""}]",Frontiers in psychology,['10.3389/fpsyg.2020.01262'] 2998,32587571,Ticagrelor Is Superior to Clopidogrel in Inhibiting Platelet Reactivity in Patients With Minor Stroke or TIA.,"Background: The combination of clopidogrel and aspirin is recommended for the treatment of patients with acute minor stroke or transient ischemic attack (TIA). However, with varied clopidogrel resistance (often due to CYP2C19 loss-of-function (LOF) alleles), alternatives like ticagrelor have been suggested. Previous studies showed that ticagrelor had a lower platelet reactivity assessed by VerifyNow P2Y12 assay than clopidogrel. We aimed to compare the effect of ticagrelor vs. clopidogrel on platelet reactivity assessed by a different method (Aggrestar platelet function analyzer) and analyze whether CYP2C19 genotypes were involved. Methods: A pre-specified subgroup analysis of a randomized controlled trial- Platelet Reactivity in Acute Non-disabling Cerebrovascular Events (PRINCE) was conducted. Patients with minor stroke or TIA were randomized for treatment with ticagrelor plus aspirin or clopidogrel plus aspirin. Platelet reactivity was assessed by Aggrestar (PL) platelet function analyzer and high on-treatment platelet reactivity (HOPR) on ticagrelor or clopidogrel was compared. Clinical outcomes included any stroke, composite vascular events and bleeding events within 90 days. Patients were categorized into carriers and non-carriers according to the carrier status of CYP2C19 LOF alleles. Results: Among 675 patients enrolled in the PRINCE trial, 387 patients were included in this subgroup: 197 were randomized to ticagrelor plus aspirin and 190 to clopidogrel plus aspirin. At 90 ± 7 days, compared with clopidogrel/aspirin group, the proportion of HOPR in ticagrelor/aspirin group was significantly lower (19.6 vs. 40.8%, P < 0.001). No significant treatment-by-genotype interactions were found ( P for interaction = 0.12). Within 90 days, a trend toward a lower risk of new stroke in ticagrelor/aspirin compared to clopidogrel/aspirin was observed (4.6 vs. 9.5%, HR 0.47, 95% CI 0.21-1.05, P = 0.06). Conclusions: Ticagrelor is superior to clopidogrel in inhibiting platelet reactivity measured by the PL platelet function analyzer among patients with acute minor stroke or TIA. Our study confirmed the finding of the main analysis of PRINCE trial in a different assay. Large randomized controlled trials are needed to evaluate our findings. Clinical Trial Registration: Clinicaltrials.gov NCT02506140.",2020,"Within 90 days, a trend toward a lower risk of new stroke in ticagrelor/aspirin compared to clopidogrel/aspirin was observed (4.6 vs. 9.5%, HR 0.47, 95% CI 0.21-1.05, P = 0.06). ","['675 patients enrolled in the PRINCE trial, 387 patients were included in this subgroup: 197', 'Patients with minor stroke or TIA', 'patients with acute minor stroke or TIA', 'patients with acute minor stroke or transient ischemic attack (TIA', 'Patients With Minor Stroke or TIA', 'Patients were categorized into carriers and non-carriers according to the carrier status of CYP2C19 LOF alleles']","['Ticagrelor', 'ticagrelor plus aspirin', 'Clopidogrel', 'ticagrelor plus aspirin or clopidogrel plus aspirin', 'clopidogrel/aspirin', 'ticagrelor/aspirin', 'ticagrelor vs. clopidogrel', 'clopidogrel plus aspirin', 'clopidogrel', 'clopidogrel and aspirin', 'ticagrelor']","['platelet reactivity', 'Platelet reactivity', 'proportion of HOPR', 'Aggrestar (PL) platelet function analyzer and high on-treatment platelet reactivity (HOPR', 'lower risk of new stroke', 'stroke, composite vascular events and bleeding events']","[{'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0449439', 'cui_str': 'Carrier status'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",387.0,0.115427,"Within 90 days, a trend toward a lower risk of new stroke in ticagrelor/aspirin compared to clopidogrel/aspirin was observed (4.6 vs. 9.5%, HR 0.47, 95% CI 0.21-1.05, P = 0.06). ","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",Frontiers in neurology,['10.3389/fneur.2020.00534'] 2999,32587652,Outpatient Management of Bronchial Asthma: A Comparative Analysis Between Guideline-Directed Management and Usual Management.,"Background Bronchial asthma is a common controllable disease that causes a serious economic and social burden. The Global Initiative for Asthma (GINA) was developed to help guide clinicians in appropriate management of asthma. Despite the existence of published guidelines, common practice in many primary care clinics follows usual care based on clinical gestalt. This study aims to determine if there is a statistically significant difference in outcomes between patients receiving guideline-directed therapy when compared to those receiving usual clinician therapy. Methods A total of 300 patients were included in this study. Among them, 139 patients received guideline-directed medical therapy (GDMT group) and 161 received usual medical therapy (UMT group). Logistic regression models were utilized to determine if there was a significant difference in outcomes for patients comparing number of exacerbations and number of hospitalizations. Results More patients in GDMT group suffered from recorded exacerbations in the prior year with 43.9% having one, 3.6% having two, and 0.7% having three, compared to the frequencies of exacerbations in the UMT group (29.2%, 1.9%, and 1.2%, respectively) (P < 0.05). Cumulative number of hospitalizations due to asthma exacerbations in the prior year was also higher in GDMT group compared to the UMT group (one in 5.8% GDMT vs. 3.1% UMT; two in 0.0% GDMT vs. 0.6% UMT) without statistically significant difference (P = 0.349). Conclusions Primary care providers' adherence to the 2018 GINA guidelines for asthma treatment did not offer benefit to patient outcomes, such as number of exacerbations or hospitalizations, compared to the usual medical care of bronchial asthma. Patient-tailored care may offer reduction in the rates of exacerbations and hospitalization.",2020,"Conclusions Primary care providers' adherence to the 2018 GINA guidelines for asthma treatment did not offer benefit to patient outcomes, such as number of exacerbations or hospitalizations, compared to the usual medical care of bronchial asthma.","['A total of 300 patients were included in this study', 'Bronchial Asthma', '139 patients received guideline-directed medical therapy (GDMT group) and 161 received']","['usual medical therapy (UMT group', 'UMT', 'GDMT']","['Cumulative number of hospitalizations due to asthma exacerbations', 'frequencies of exacerbations', 'recorded exacerbations', 'number of exacerbations or hospitalizations']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]",300.0,0.0499517,"Conclusions Primary care providers' adherence to the 2018 GINA guidelines for asthma treatment did not offer benefit to patient outcomes, such as number of exacerbations or hospitalizations, compared to the usual medical care of bronchial asthma.","[{'ForeName': 'Jeyanthan', 'Initials': 'J', 'LastName': 'Jayakumaran', 'Affiliation': 'Department of Medicine, Cooper University Health Care, Camden, NJ, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Hunter', 'Affiliation': 'Cooper Research Institute, Cooper Medical School of Rowan University, Camden, NJ, USA.'}, {'ForeName': 'Satyajeet', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Department of Medicine, Cooper University Health Care, Camden, NJ, USA.'}]",Journal of clinical medicine research,['10.14740/jocmr4208'] 3000,32587711,"Comparison of pre-hospital triage training by role playing and lecture on nursing students' knowledge, attitude and performance.","Aim The objective of this study was to determine and compare the effectiveness of two methods of role playing and lecture on knowledge, attitude and performance of nursing' students in the context of pre-hospital triage. Design This was a pre-test-posttest quasi-experimental study. Methods A total of 66 nursing students (third year) were assigned to two groups, the control group ( N  = 23) and intervention group ( N  = 23). START pre-hospital triage was taught to two groups by using a lecture (control group) and role playing (intervention group) method. Immediately before the intervention and 4 weeks after the training, students' knowledge, attitude and practice in both groups were assessed through a questionnaire and a checklist. Data were analysed using SPSS software version 21. Results The results showed that the mean scores of knowledge, attitude and performance increased after intervention in both groups ( p  < .05). The mean ( SD ) difference of total performance score from baseline to follow-up in the experimental group and the control group was 23.91 (13.83) and 7.00 (13.20), respectively ( p  < .001). While there was no significant difference between the mean ( SD ) difference of knowledge and attitude scores in the experimental group and the control group before and after the intervention ( p  > .05).",2020,"The results showed that the mean scores of knowledge, attitude and performance increased after intervention in both groups ( p  < .05).",['66 nursing students (third year'],"['role playing and lecture', 'lecture (control group) and role playing (intervention group) method', 'pre-hospital triage training by role playing and lecture']","['knowledge, attitude and performance', 'mean ( SD ) difference of knowledge and attitude scores', 'mean ( SD ) difference of total performance score', 'mean scores of knowledge, attitude and performance']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",66.0,0.0248427,"The results showed that the mean scores of knowledge, attitude and performance increased after intervention in both groups ( p  < .05).","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Heidarzadeh', 'Affiliation': 'Department of Nursing Faculty of Nursing and Midwifery Ilam University of Medical Sciences Ilam Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Heidarzadeh', 'Affiliation': 'Emam Ali Hospital Ilam University of Medical sciences Ilam Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Azadi', 'Affiliation': 'Department of Nursing Faculty of Nursing and Midwifery Ilam University of Medical Sciences Ilam Iran.'}]",Nursing open,['10.1002/nop2.464'] 3001,32587722,Evaluating the impact of a multimedia training versus lecture training on attitudes and practices in paediatric nurses in children pain management: A randomized controlled trial.,"Aim The aim of this study was to evaluate the effect of a multimedia training on pain management attitudes and practices of paediatric nurses. Design A single-blind randomized trial. Methods Paediatric nurses ( N  = 120) from a public hospital randomly allocated into two groups, lecturing and multimedia training groups. Nurses in the control group received four one-hour training sessions. In the intervention group, the same educational content was used as a film with text, audio and animation and presented as a multimedia CD. In both groups, using a questionnaire, we measured pain management attitudes and skills at baseline and then 1 week and 1 month after the training over. Data were analysed in SPSS20 software, and p  < .05 was considered statistically significant. Results The mean of attitude scores of the lecturing group was 104.74 one week after the study and 109.40 one month later versus 74.72. The above-mentioned scores in the multimedia group were 112.72 and 115.04, respectively, versus 78.70 ( p  < .001). Also, the mean scores of nurses' performance in the lecturing group before, 1 week and 1 month after the study were 12.48, 26.60 and 28.22, respectively, versus 12.58, 28.68 and 28.98, in multimedia group; this difference was statistically significant ( p  < .05).",2020,The mean of attitude scores of the lecturing group was 104.74 one week after the study and 109.40 one month later versus 74.72.,"['paediatric nurses in children pain management', 'Methods\n\n\nPaediatric nurses ( N \xa0=\xa0120) from a public hospital randomly allocated into two groups']","['multimedia training', 'lecturing and multimedia training groups', 'multimedia training versus lecture training']","['pain management attitudes and skills', ""mean scores of nurses' performance"", 'mean of attitude scores']","[{'cui': 'C1527237', 'cui_str': 'Pediatric nurse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",120.0,0.0491747,The mean of attitude scores of the lecturing group was 104.74 one week after the study and 109.40 one month later versus 74.72.,"[{'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Arzani', 'Affiliation': 'Non-Communicable Pediatric Disease Research Center Health Research Institute School of Nursing and Midwifery Babol University of Medical Sciences Babol Iran.'}, {'ForeName': 'Sousan', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Pediatric Nursing Department Iranian Center for Evidence-Based Practice School of Nursing and Midwifery Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Samereh', 'Initials': 'S', 'LastName': 'Poorkaremi', 'Affiliation': 'Pediatric Nursing Department School of Nursing and Midwifery Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Taheri Ezbarami', 'Affiliation': 'School of Nursing and Midwifery Guilan University of Medical Sciences Rasht Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Ghojazadeh', 'Affiliation': 'Research Center of Evidence Based Medicine School of Medicine Tabriz University of Medical Sciences Tabriz Iran.'}]",Nursing open,['10.1002/nop2.476'] 3002,32587723,Intervention study of a foot-care programme enhancing knowledge and practice among nurses and care workers at in-home service providers.,"Aim To evaluate the foot-care educational programme for nurses and care workers at in-home service providers. Design A non-randomized controlled study with random cluster sampling method. Methods Study participants were nurses and care workers of 21 in-home service providers, including home-visit nursing and care providers, 1-day care service centres or care centres with rehabilitation programme in Japan. Foot-care programme with foot-care tools as a package or standard care comprising 3-5 sessions over 2 months was provided to 110 participants (87 were on analysis). The outcomes were changes in foot-care knowledge and scores in pre-post interventions. Data were analysed with descriptive statistics, t test, logistic regression analysis and ANCOVA. Results Before adjusting for background, total scores of knowledge and practice categories were higher than the baseline in the intervention group (43 participants) compared with the control group (44 participants). After background correction due to potential bias of non-random cluster sampling, significant between group differences were observed in mean score changes in skin and consultation subscales of the practice category.",2020,"Results Before adjusting for background, total scores of knowledge and practice categories were higher than the baseline in the intervention group (43 participants) compared with the control group (44 participants).","['nurses and care workers at in-home service providers', 'participants were nurses and care workers of 21 in-home service providers, including home-visit nursing and care providers, 1-day care service centres or care centres with rehabilitation programme in Japan', '110 participants\xa0(87 were on analysis']","['foot-care educational programme', 'foot-care programme']","['changes in foot-care knowledge and scores', 'total scores of\xa0knowledge and practice categories']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0150240', 'cui_str': 'Foot care'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0419737,"Results Before adjusting for background, total scores of knowledge and practice categories were higher than the baseline in the intervention group (43 participants) compared with the control group (44 participants).","[{'ForeName': 'Kashiko', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Graduate School of Medicine School of Health Sciences Nagoya University Nagoya City Japan.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Stolt', 'Affiliation': 'Department of Nursing Science University of Turku Turku Finland.'}]",Nursing open,['10.1002/nop2.479'] 3003,32587732,Comparing student achievement in traditional learning with a combination of blended and flipped learning.,"Aim The aim of this study was to investigate the effectiveness of blended learning with a flipped classroom design on student academic achievement in a Bachelor of Science in Nursing course. Design A quasi-experimental study. Method Students were split into an experimental blended learning with a flipped classroom design group and a control group using the traditional, teacher-centred learning method. Data were collected during spring 2018 (13.3 weeks) and student's grades for the registered course and their grade point average (GPA) were recorded. Results Findings showed statistically significant increases in student grades in the experimental group. Predictability calculations also showed better achievement of learning outcomes if a blended learning with a flipped classroom design is continued to be used in the future.",2020,"Results Findings showed statistically significant increases in student grades in the experimental group.",['student academic achievement in a Bachelor of Science in Nursing course'],"['blended learning with a flipped classroom design', 'experimental blended learning with a flipped classroom design group and a control group using the traditional, teacher-centred learning method', 'traditional learning with a combination of blended and flipped learning']",['student grades'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0122235,"Results Findings showed statistically significant increases in student grades in the experimental group.","[{'ForeName': 'Suhaila', 'Initials': 'S', 'LastName': 'Halasa', 'Affiliation': 'Maternal and Child Health Nursing Department School of Nursing The University of Jordan Amman Jordan.'}, {'ForeName': 'Nimer', 'Initials': 'N', 'LastName': 'Abusalim', 'Affiliation': 'School of Foreign Languages The University of Jordan Amman Jordan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rayyan', 'Affiliation': 'School of Foreign Languages The University of Jordan Amman Jordan.'}, {'ForeName': 'Rose E', 'Initials': 'RE', 'LastName': 'Constantino', 'Affiliation': 'Department of Health and Community Systems School of Nursing University of Pittsburgh Pittsburgh PA USA.'}, {'ForeName': 'Omayah', 'Initials': 'O', 'LastName': 'Nassar', 'Affiliation': 'Maternal and Child Health Nursing Department School of Nursing The University of Jordan Amman Jordan.'}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Amre', 'Affiliation': 'Community Health Nursing Department School of Nursing The University of Jordan Amman Jordan.'}, {'ForeName': 'Moayad', 'Initials': 'M', 'LastName': 'Sharab', 'Affiliation': 'School of Foreign Languages The University of Jordan Amman Jordan.'}, {'ForeName': 'Insirah', 'Initials': 'I', 'LastName': 'Qadri', 'Affiliation': 'Maternal and Child Health Nursing Department School of Nursing The University of Jordan Amman Jordan.'}]",Nursing open,['10.1002/nop2.492'] 3004,32587766,Efficacy of Thiamine in the Treatment of Postcardiac Arrest Patients: A Randomized Controlled Study.,"Background Thiamine administration has been shown to improve survival in a postcardiac arrest animal study. We aimed to evaluate the efficacy of thiamine in comatose out-of-hospital cardiac arrest (OHCA) patients following return of spontaneous circulation. Methods A randomized, double-blinded, placebo-controlled study was conducted. Thirty-seven OHCA patients were randomly assigned to receive either thiamine 100 mg every 8 hours or a placebo. The primary outcome was 28-day all-cause mortality. Results Over the course of 2 years, 37 patients were randomized to either receive thiamine ( n  = 20) or a placebo ( n  = 17). The primary outcome was not different between the groups: 10/20 (50%) in the thiamine group vs. 8/17 (47.1%) in the placebo group ( P =0.93 by the log-rank test). There were no significant differences in secondary outcomes between the groups (good neurological outcome, lactate level, and S100B level). Conclusions In this study, there were no significant differences in survival outcome. Further studies with a larger population are necessary to confirm these results.",2020,"There were no significant differences in secondary outcomes between the groups (good neurological outcome, lactate level, and S100B level). ","['comatose out-of-hospital cardiac arrest (OHCA) patients following return of spontaneous circulation', '37 patients', 'Thirty-seven OHCA patients', 'Postcardiac Arrest Patients']","['thiamine 100\u2009mg every 8 hours or a placebo', 'thiamine', 'Thiamine', 'placebo']","['survival outcome', 'neurological outcome, lactate level, and S100B level', '28-day all-cause mortality', 'survival']","[{'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0993029', 'cui_str': 'Thiamine 100 MG'}, {'cui': 'C0585326', 'cui_str': 'Every eight hours'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",37.0,0.572052,"There were no significant differences in secondary outcomes between the groups (good neurological outcome, lactate level, and S100B level). ","[{'ForeName': 'Suntornwit', 'Initials': 'S', 'LastName': 'Pradita-Ukrit', 'Affiliation': 'Critical Care Medicine Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Veerapong', 'Initials': 'V', 'LastName': 'Vattanavanit', 'Affiliation': 'Critical Care Medicine Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}]",Critical care research and practice,['10.1155/2020/2981079'] 3005,32587924,"Efficacy of adding midazolam to paracetamol in pain control of patients with a primary headache: A randomized, clinical trial study.","OBJECTIVES This study aimed to determine the effect of adding intravenous midazolam to paracetamol in the treatment of patients with primary headache referring to the emergency department. METHODS In a randomized clinical trial, 120 patients (18-65 years old) with primary headache referring to the emergency department were enrolled. Patients were divided into two groups (case: paracetamol + midazolam and control: paracetamol + placebo), and the treatment was administered based on the treatment group. The severity of pain (according to the initial Visual Analog Scale) and at different times after the treatment onset (15, 30, and 60 min) and the degree of satisfaction with the treatment were compared in two groups of patients. RESULTS There were no statistically difference between the two groups about the median of pain severity at the time of 0 min (case: 8 vs. control: 8), 15 min (case: 6 vs. control: 6), and 30 min (case: 4 vs. control: 4) with P > 0.05. Headache severity at 60 min after the treatment onset in the case group (median: 1) was less than that of the control group (median: 3). There was also a statistically significant difference in the median of patient satisfaction in the case group (case: 9 and control: 7 with P < 0.001) and satisfaction in the case group was higher. CONCLUSIONS Based on our primary and secondary outcomes and the results of the study, we conclude that adding intravenous midazolam to paracetamol do not improve the therapeutic response ratio over time, but the effect of this intervention appeared after 1 h.",2020,"There was also a statistically significant difference in the median of patient satisfaction in the case group (case: 9 and control: 7 with P < 0.001) and satisfaction in the case group was higher. ","['patients with primary headache referring to the emergency department', '120 patients (18-65 years old) with primary headache referring to the emergency department were enrolled', 'pain control of patients with a primary headache']","['paracetamol', 'paracetamol + midazolam and control: paracetamol + placebo', 'midazolam']","['Headache severity', 'severity of pain', 'satisfaction', 'degree of satisfaction', 'median of pain severity', 'median of patient satisfaction', 'therapeutic response ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",120.0,0.0389993,"There was also a statistically significant difference in the median of patient satisfaction in the case group (case: 9 and control: 7 with P < 0.001) and satisfaction in the case group was higher. ","[{'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Amini-Parikhani', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, East Azerbaijan, I. R, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaffarazad', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences Tabriz, East Azerbaijan, I. R, Tabriz, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Soleimanpour', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Haniyeh', 'Initials': 'H', 'LastName': 'Ebrahimi-Bakhtavar', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences Tabriz, East Azerbaijan, I. R, Tabriz, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Rahmani', 'Affiliation': 'Emergency Medicine Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Turkish journal of emergency medicine,['10.4103/2452-2473.285011'] 3006,32587927,The assessment of ice pack effect in pain reduction during digital nerve block: A randomized clinical study.,"OBJECTIVES Digital nerve block is a painful procedure. Several methods have been proposed to decrease the injection pain. Applying an ice pack is a pertinent choice due to its effectiveness on pain reduction, convenience, and low costs. In this study, the degree of injection pain reduction was assessed after applying an ice pack to the site of anesthetic injection. METHODS One hundred participants with traumatic finger injury were assessed. Digital nerve block was performed in fifty patients in the intervention group after 6 min of ice application. In the control group, this procedure was done without ice. The primary outcome was the difference between the needle stick and infiltration pain scores with and without ice pack. The secondary outcome the patient satisfaction score. The protocol of this study was approved by the Institutional Review Board, and it is registered in the Iranian Registry of Clinical Trials. RESULTS The pain score was assessed using a Numeric Rating Scale. Both the needle skin and infiltration pain scores were statistically significantly lower in the intervention group ( P < 0.001). The mean and median needle stick pain scores were 1.5 and 1.0 in the intervention group and 6.8 and 7.0 in the control group, respectively. Moreover, the mean and median infiltration pain scores were 2.7 and 2.0 in the intervention group and 8.5 and 9.0 in the control group, respectively. Patient satisfaction score was significantly higher in the intervention group. CONCLUSIONS Ice pack is inexpensive, readily available, and is easy to apply. We recommend this method to reduce the injection pain before digital nerve block in the emergency department.",2020,Both the needle skin and infiltration pain scores were statistically significantly lower in the intervention group ( P < 0.001).,"['One hundred participants with traumatic finger injury were assessed', 'pain reduction during digital nerve block']",[],"['Patient satisfaction score', 'mean and median needle stick pain scores', 'Numeric Rating Scale', 'needle skin and infiltration pain scores', 'injection pain', 'Digital nerve block', 'needle stick and infiltration pain scores', 'mean and median infiltration pain scores', 'pain score', 'patient satisfaction score', 'injection pain reduction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0016124', 'cui_str': 'Injury of finger'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0576791', 'cui_str': 'Digital nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",[],"[{'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085178', 'cui_str': 'Injuries, Needlestick'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0576791', 'cui_str': 'Digital nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",100.0,0.143461,Both the needle skin and infiltration pain scores were statistically significantly lower in the intervention group ( P < 0.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rasooli', 'Affiliation': 'Department of Emergency Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Sotoodehnia', 'Affiliation': 'Department of Emergency Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nejati', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Department of Emergency Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Turkish journal of emergency medicine,['10.4103/2452-2473.281628'] 3007,32587945,Protocol of Aerobic Exercise and Cognitive Health (REACH): A Pilot Study.,"A growing body of evidence supports that aerobic exercise can decrease the risk of future cognitive impairment and Alzheimer's disease (AD). There is a pressing need to rigorously determine whether cognitively normal yet at-risk individuals stand to benefit from the protective effects of exercise. The present study will test the feasibility of an aerobic exercise intervention in such a population and inform the design of a larger-scale randomized, controlled trial examining the effect of aerobic exercise on biomarkers of AD in late-middle-aged, at-risk individuals. This was a single-site, 1 : 1 block-randomized, parallel, two-arm trial. Cognitively normal participants aged 45-80 with documentation of familial and genetic AD risk factors were randomly assigned to one of two interventions. The Usual Physical Activity group was provided educational materials about exercise. The Enhanced Physical Activity intervention delivered 26 weeks of individualized and supervised aerobic exercise. Exercise duration and intensity were incrementally increased to 150 min/week and 70-80% of heart rate reserve, respectively. Retention and adherence were measured to assess study feasibility. In addition, pre- and post- intervention differences between the two arms were evaluated for cardiorespiratory fitness, physical activity, brain glucose metabolism, cerebral structure, vascular health, memory, executive function, and mood. Data from randomized controlled trials of exercise training are needed to identify the proper exercise prescription for reducing accumulation of AD biomarkers in cognitively normal individuals. The current trial will contribute to filling that gap while informing the design of large-scale trials.",2020,Cognitively normal participants aged 45-80 with documentation of familial and genetic AD risk factors were randomly assigned to one of two interventions.,"['Cognitively normal participants aged 45-80 with documentation of familial and genetic AD risk factors', 'late-middle-aged, at-risk individuals', 'cognitively normal individuals']","['aerobic exercise intervention', 'exercise training', 'individualized and supervised aerobic exercise', 'Aerobic Exercise and Cognitive Health (REACH', 'aerobic exercise']","['Retention and adherence', 'Exercise duration and intensity', 'cardiorespiratory fitness, physical activity, brain glucose metabolism, cerebral structure, vascular health, memory, executive function, and mood']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0242202', 'cui_str': 'Cerebral structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.210819,Cognitively normal participants aged 45-80 with documentation of familial and genetic AD risk factors were randomly assigned to one of two interventions.,"[{'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Gaitán', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Boots', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Dougherty', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Dorothy F', 'Initials': 'DF', 'LastName': 'Edwards', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Carol C', 'Initials': 'CC', 'LastName': 'Mitchell', 'Affiliation': 'Department of Medicine, Cardiovascular Medicine Division, University of Wisconsin Atherosclerosis Imaging Research Program, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Bradley T', 'Initials': 'BT', 'LastName': 'Christian', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Dane B', 'Initials': 'DB', 'LastName': 'Cook', 'Affiliation': 'Department of Kinesiology, University of Wisconsin School of Education, Madison, WI, USA.'}, {'ForeName': 'Ozioma C', 'Initials': 'OC', 'LastName': 'Okonkwo', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}]",Journal of Alzheimer's disease reports,['10.3233/ADR-200180'] 3008,32588060,"Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial.","AIM The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. METHODS AND RESULTS In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20-0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19-1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772). CONCLUSION For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting. STUDY REGISTRATION http://www.clinicaltrials.com; Identifier: NCT02284750.",2020,"At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772). ","['653 patients with complex bifurcation lesions at 49 international centres', 'patients with DEFINITION criteria-defined complex coronary bifurcation lesions', 'patients with complex coronary bifurcation lesions']","['stent and provisional stenting techniques', 'systematic two-stent technique (two-stent group) or provisional stenting (provisional group']","['clinical outcomes', 'incidence of cardiac death', 'TLF', 'TVMI', 'clinically driven TLR', 'composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",653.0,0.323233,"At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772). ","[{'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': ""Division of Cardiology, Xijing Hospital, 4th Military Medical University, Xi'an, China.""}, {'ForeName': 'Teguh', 'Initials': 'T', 'LastName': 'Santoso', 'Affiliation': 'Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarta, Indonesia.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Munawar', 'Affiliation': 'Division of Cardiology, Binawaluya Cardiac Center, Jakarta, Indonesia.'}, {'ForeName': 'Damras', 'Initials': 'D', 'LastName': 'Tresukosol', 'Affiliation': 'Division of Cardiology, Medicine Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Guangzhou Red Cross Hospital, Guangzhou, China.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Sheiban', 'Affiliation': 'Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Oriental General Hospital, Huainan, China.'}, {'ForeName': 'Nai-Liang', 'Initials': 'NL', 'LastName': 'Tian', 'Affiliation': 'Division of Cardiology, Nanjing Heart Center, Nanjing, China.'}, {'ForeName': 'Alfredo E', 'Initials': 'AE', 'LastName': 'Rodríguez', 'Affiliation': 'Division of Cardiology, Otamendi Hospital, Buenos Aires, Argentina.'}, {'ForeName': 'Chotnoparatpat', 'Initials': 'C', 'LastName': 'Paiboon', 'Affiliation': 'Division of Cardiology, Bangkok General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lavarra', 'Affiliation': 'Division of Cardiology, Jilin Cardiovascular Hospital, Changchun, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Division of Cardiology, Taicang 1st People's Hospital, Taicang, China.""}, {'ForeName': 'Kitigon', 'Initials': 'K', 'LastName': 'Vichairuangthum', 'Affiliation': 'Division of Cardiology, Bangplee Hospital, Bangkok, Thailand.'}, {'ForeName': 'Hesong', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Division of Cardiology, Wuhan Tongji Hospital, United Medical University, Wuhan, China.'}, {'ForeName': 'Lianglong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Fujian Medical University Union Hospital, Fujian Institute of Coronary Artery Disease, Fujian Heart Medical Center, Fuzhou, China.'}, {'ForeName': 'Ruiyan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Shanghai Ruijin Hospital, Shanghai Communication University, Shanghai, China.'}, {'ForeName': 'Shiqin', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Division of Cardiology, Xinhua Hospital, Huainan, China.'}, {'ForeName': 'Fengtang', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ""Division of Cardiology, Gansu Provincial People's Hospital, Lanzhou, China.""}, {'ForeName': 'Zening', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Division of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': ""Division of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, China.""}, {'ForeName': 'Likun', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Division of Cardiology, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Shangyu', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Division of Cardiology, Tianjin 4th Central Hospital, Tianjin, China.'}, {'ForeName': 'Xueming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Division of Cardiology, Wuxi 3rd People's Hospital, Wuxi, China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Division of Cardiology, Yixing People's Hospital, Yixing, China.""}, {'ForeName': 'Wei-Hsian', 'Initials': 'WH', 'LastName': 'Yin', 'Affiliation': 'Division of Cardiology, Cheng-Hsin General Hospital, Taipei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Division of Cardiology, Jintan Traditional Chinese Medicine Hospital, Jintan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Division of Cardiology, Liyang Hospital of Traditional Chinese Medicine, Liyang, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Division of Cardiology, Chuzhou People's Hospital, Chuzhou, China.""}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Division of Cardiology, Huaian 2nd People's Hospital, Huaian, China.""}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, Xinyang Central Hospital, Xinyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Lianyungang Traditional Chinese Medicine Hospital, Lianyungang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': 'Division of Cardiology, XuanCheng Central Hospital, Xuancheng, China.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ""Division of Cardiology, Xuyi People's Hospital, Xuyi, China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Division of Cardiology, Jintan People's Hospital, Jintan, China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Division of Cardiology, Huainan People's Hospital, Huainan, China.""}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Division of Cardiology, 2nd People's Hospital, Shandong University, Jinan, China.""}, {'ForeName': 'Qihua', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Changzhou Traditional Chinese Medicine Hospital, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Division of Cardiology, Anqing 1st People's Hospital, Anqing, China.""}, {'ForeName': 'Leng', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Division of Cardiology, Changshu People's Hospital, Changshu, China.""}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Gan', 'Affiliation': 'Division of Cardiology, 17th Metallurgical Hospital, Maanshan, China.'}, {'ForeName': 'Mengyue', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Division of Cardiology, Qingdao Campus of Fuwai Hospital, Qingdao, China.'}, {'ForeName': 'Defeng', 'Initials': 'D', 'LastName': 'Pan', 'Affiliation': ""Division of Cardiology, Xuzhou 2nd People's Hospital, Xuzhou, China.""}, {'ForeName': 'Zhenglu', 'Initials': 'Z', 'LastName': 'Shang', 'Affiliation': ""Division of Cardiology, Wuxi Huishan District People's Hospital, Wuxi, China.""}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Division of Cardiology, Nanjing 81 Hospital, Nanjing, China.'}, {'ForeName': 'Zhizhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Division of Cardiology, Hongze People's Hospital, Huai'an, China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Trinity College, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Ican School of Medicine at Mount Sinai, New York, NY, USA and The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.'}]",European heart journal,['10.1093/eurheartj/ehaa543'] 3009,32588071,Invited Discussion on: Evaluation of the Sensitivity of the Nipple-Areola Complex in Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release: A Randomized Controlled Trial.,,2020,,['Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",[],[],,0.0915365,,"[{'ForeName': 'Maurice Y', 'Initials': 'MY', 'LastName': 'Nahabedian', 'Affiliation': 'Virginia Commonwealth University, Inova Branch, National Center for Plastic Surgery, 7601 Lewinsville Dr., #400, McLean, VA, 22102, USA. DrNahabedian@aol.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01839-3'] 3010,32588134,"Norepinephrine prophylaxis for postspinal anesthesia hypotension in parturient undergoing cesarean section: a randomized, controlled trial.","OBJECTIVE To investigate the efficacy and safety of prophylactic infusion of norepinephrine (NE) versus normal saline in patients undergoing cesarean section. METHODS Patients (n = 97) were randomized to receive a bolus of NE (6 μg) immediately following spinal anesthesia with maintenance NE (0.05 μg/kg/min IV) or normal saline (n = 98). The primary endpoint was the incidence of postspinal anesthesia hypotension [systolic blood pressure (SBP) < 80% of baseline] at 1-20 min following spinal anesthesia. Secondary outcomes were the overall stability of SBP control versus baseline, inferior vena cava collapsibility index (IVC-CI), other adverse events (bradycardia, nausea, vomiting, and hypertension), and neonatal outcomes (blood gas values and Apgar scores). RESULTS The rates of postspinal anesthesia hypotension and severe postspinal anesthesia hypotension (SBP < 60% of the baseline) were significantly lower in the NE group (17.5% vs. 62.2%, p < 0.001; 7.2% vs. 17.4%, p = 0.031). In the NE group, SBP remained more stable and closer to baseline (p < 0.001), and IVC-CI values were lower 5 min after spinal anesthesia and 5 min after fetal delivery (p = 0.045; p < 0.001, respectively). Other adverse effects and neonatal outcomes were not different between the two groups. CONCLUSION Prophylactic NE infusion effectively lowers the incidence of postspinal anesthesia hypotension and does not increase other adverse events in patients or neonates.",2020,Prophylactic NE infusion effectively lowers the incidence of postspinal anesthesia hypotension and does not increase other adverse events in patients or neonates.,"['patients or neonates', 'Patients (n\u2009=\u200997', 'patients undergoing cesarean section', 'parturient undergoing cesarean section']","['normal saline', 'spinal anesthesia with maintenance NE', 'norepinephrine (NE', 'Norepinephrine prophylaxis', 'Prophylactic NE', 'NE']","['rates of postspinal anesthesia hypotension and severe postspinal anesthesia hypotension', 'IVC-CI values', 'overall stability of SBP control versus baseline, inferior vena cava collapsibility index (IVC-CI), other adverse events (bradycardia, nausea, vomiting, and hypertension), and neonatal outcomes (blood gas values and Apgar scores', 'incidence of postspinal anesthesia hypotension [systolic blood pressure (SBP', 'adverse events', 'incidence of postspinal anesthesia hypotension', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.354647,Prophylactic NE infusion effectively lowers the incidence of postspinal anesthesia hypotension and does not increase other adverse events in patients or neonates.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China. xinlini6@nyfy.com.cn.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05663-7'] 3011,32588153,"Effects of Daikenchuto on postoperative gastrointestinal motility in colorectal carcinoma patients with abdominal pain and distension: a prospective, randomized trial.","PURPOSE To investigate the efficacy and safety of Daikenchuto (DKT) for colorectal cancer patients undergoing surgery with the potential risk of postoperative ileus (POI). METHODS Colorectal cancer patients with abdominal pain and distention, scheduled for surgery, were randomly assigned to a DKT group or a control group. Patients assigned to the DKT group were given 15 g of DKT per day during the perioperative period. We then compared the perioperative gastrointestinal symptoms between the two groups. RESULTS The aim for a sample size of 30 patients per group was not reached in time, so we conducted an analysis on 16 patients in each group. The visual Analogue Scale scores for abdominal pain and distention were similar in the two groups. The number of bowel movements per day on postoperative days (PODs) 1, 2, and 6 were significantly lower in the DKT group. The incidence of a sensation of incomplete bowel evacuation on PODs 3 and 28 was also significantly lower in the DKT group. There were no adverse events thought to be related to DKT. CONCLUSIONS DKT could potentially inhibit diarrhea and reduce the number of bowel movements per day and the sensation of incomplete bowel evacuation after colorectal surgery. Thus, the perioperative use of DKT may be safe for colorectal cancer patients with abdominal pain and distention, who undergo surgery.",2020,The incidence of a sensation of incomplete bowel evacuation on PODs 3 and 28 was also significantly lower in the DKT group.,"['colorectal carcinoma patients with abdominal pain and distension', 'Colorectal cancer patients with abdominal pain and distention, scheduled for surgery', '30 patients per group was not reached in time, so we conducted an analysis on 16 patients in each group', 'colorectal cancer patients with abdominal pain and distention, who undergo surgery', 'colorectal cancer patients undergoing surgery with the potential risk of postoperative ileus (POI']","['DKT', 'Daikenchuto (DKT', 'Daikenchuto']","['perioperative gastrointestinal symptoms', 'visual Analogue Scale scores for abdominal pain and distention', 'postoperative gastrointestinal motility', 'number of bowel movements', 'incidence of a sensation of incomplete bowel evacuation']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}]","[{'cui': 'C0909027', 'cui_str': 'dai-kenchu-to'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0426639', 'cui_str': 'Incomplete passage of stool'}]",,0.0528345,The incidence of a sensation of incomplete bowel evacuation on PODs 3 and 28 was also significantly lower in the DKT group.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Wakasugi', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan. wakasugimasaki@gmail.com.'}, {'ForeName': 'Yozo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Tei', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ueshima', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Akamatsu', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Toshirou', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}]",Surgery today,['10.1007/s00595-020-02052-0'] 3012,32588194,"Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction.","AIM Blood flow restriction (BFR) exercise is a common alternative to traditional high-load resistance exercise used to increase muscle size and strength. Some populations utilizing BFR at a low load may wish to limit their cardiovascular response to exercise. Different contraction patterns may attenuate the cardiovascular response, but this has not been compared using BFR. PURPOSE To compare the cardiovascular response to unilateral (UNI), bilateral (BIL), and alternating (ALT) BFR exercise contraction patterns. METHODS Twenty healthy participants performed four sets (30 s rest) of knee extensions to failure, using 30% one-repetition maximum, 40% arterial occlusion pressure, and each of the three contraction patterns (on different days, at the same time of day, separated by 2-10 days, randomized). Cardiovascular responses, presented as pre- to post-exercise mean changes (SD), were measured using pulse wave analysis and analyzed with Bayesian RMANOVA. RESULTS ALT caused greater changes in: aortic systolic [ΔmmHg: ALT = 21(8); UNI = 13(11); BIL = 15(8); BF 10  = 29.599], diastolic [ΔmmHg: ALT = 13(8); UNI = 7(11); BIL = 8(8); BF 10  = 5.175], and mean arterial [ΔmmHg: ALT = 19(8); UNI = 11(11); BIL = 13(7); BF 10  = 48.637] blood pressures. Aortic [ΔmmHg bpm: ALT = 4945(2340); UNI = 3294(1408); BIL = 3428 (1461); BF 10  = 113.659] and brachial [ΔmmHg bpm: ALT = 6134(2761); UNI = 4300(1709); BIL = 4487(1701); BF 10  = 31.845] rate pressure products, as well as heart rate [Δbpm: ALT = 26(14); UNI = 19(8); BIL = 19(11); BF 10  = 5.829] were greatest with ALT. Augmentation index [Δ%: UNI = -6(13); BIL = - 7(11); ALT = - 5(16); BF 10  = 0.155] and wave reflection magnitude [Δ%: UNI = - 5(9); BIL = - 4(7); ALT = - 4(7); BF 10  = 0.150] were not different. CONCLUSION Those at risk of a cardiovascular event may choose unilateral or bilateral BFR exercise over alternating until further work determines the degree to which it can be tolerated.",2020,"RESULTS ALT caused greater changes in: aortic systolic [ΔmmHg: ALT = 21(8); UNI = 13(11); BIL = 15(8); BF 10  = 29.599], diastolic [ΔmmHg: ALT = 13(8); UNI = 7(11); BIL = 8(8); BF 10  = 5.175], and mean arterial [ΔmmHg: ALT = 19(8); UNI = 11(11); BIL = 13(7); BF 10  = 48.637] blood pressures.","['\u20094945(2340); UNI\u2009=\u20093294(1408); BIL\u2009=\u20093428 (1461); BF 10 \u2009=\u2009113.659] and brachial [ΔmmHg\xa0bpm: ALT\u2009=\u20096134(2761); UNI\u2009=\u20094300(1709); BIL\u2009=\u20094487(1701); BF 10 \u2009=\u200931.845] rate pressure products, as well as heart rate [Δbpm: ALT\u2009=\u200926(14); UNI\u2009=\u200919(8); BIL\u2009=\u200919(11); BF 10 \u2009=\u20095.829', 'Twenty healthy participants']","['Blood flow restriction (BFR) exercise', 'unilateral, bilateral, and alternating resistance exercise with blood flow restriction', 'ALT']","[' aortic systolic', 'BFR exercise contraction patterns', 'cardiovascular response to unilateral (UNI), bilateral (BIL), and alternating (ALT', 'cardiovascular response', 'Cardiovascular responses']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]",20.0,0.0326334,"RESULTS ALT caused greater changes in: aortic systolic [ΔmmHg: ALT = 21(8); UNI = 13(11); BIL = 15(8); BF 10  = 29.599], diastolic [ΔmmHg: ALT = 13(8); UNI = 7(11); BIL = 8(8); BF 10  = 5.175], and mean arterial [ΔmmHg: ALT = 19(8); UNI = 11(11); BIL = 13(7); BF 10  = 48.637] blood pressures.","[{'ForeName': 'Daphney M', 'Initials': 'DM', 'LastName': 'Stanford', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science, Recreation and Sports Management, The University of Mississippi, 215 Turner Center, University, MS, 38677, USA.'}, {'ForeName': 'Joonsun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'McCoy', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Jessee', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science, Recreation and Sports Management, The University of Mississippi, 215 Turner Center, University, MS, 38677, USA. mbjessee@olemiss.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04401-w'] 3013,32592568,[General hydro galvanic baths in the treatment of patients with lumbosacral radiculopathy].,"INTRODUCTION Hydrogalvanic baths are a hydrotherapy method based on the combined effect of electric current and fresh water on the body. AIM OF STUDY Scientific evidence and evaluation of the effectiveness of use of general hydrogalvanic baths in the treatment of patients with lumbosacral radiculopathy with the background of degenerative spinal disorder. MATERIALS AND METHODS A randomized comparative clinical trial included 84 patients. The 1st (active) group included 43 patients, the 2nd (control) had 41 patients. Patients of the 1st group received general hydrogalvanic baths. Patients in the control group - drug treatment, including NSAIDs, muscle relaxants, anticonvulsants. The assessment was carried out before treatment, at the end of the course (on the 14th day) and 3 months after the end of treatment according to the results of neurological examination, VAS questionnaires, Pain DETECT, Beck scale, Oswestry scale, SF-36 scales, electroneuromyography (nerve conduction study). RESULTS In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%, p =0.008) and conductivity in peripheral sensory fibers. A decrease in pain was observed in both groups, however, a decrease in neuropathic pain was recorded only in patients receiving drug treatment. In the 1st group during therapy, an improvement in the emotional state in patients and a decrease in the level of depression were revealed. An analysis of long-term results showed that the delayed effect of non-drug treatment significantly increased in patients of the 1st group in comparison with the control group ( p <0.05). CONCLUSIONS Exposure to general hydrogalvanic baths is an effective way to treat lumbosacral radiculopathy, the main registered effects are: improvement of sensitivity, reduction of pain and stabilization of the emotional background. However, the studied method does not affect neuropathic pain.",2020,"In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%, p =0.008) and conductivity in peripheral sensory fibers.","['43 patients, the 2nd (control) had 41 patients', '84 patients', 'patients with lumbosacral radiculopathy', 'patients with lumbosacral radiculopathy with the background of degenerative spinal disorder']",['general hydrogalvanic baths'],"['sensitivity (the incidence of hypesthesia', 'emotional state', 'conductivity in peripheral sensory fibers', 'delayed effect of non-drug treatment', 'pain', 'neuropathic pain', 'level of depression', 'neurological examination, VAS questionnaires, Pain DETECT, Beck scale, Oswestry scale, SF-36 scales, electroneuromyography (nerve conduction study']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0154738', 'cui_str': 'Lumbosacral radiculopathy'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0037933', 'cui_str': 'Disorder of vertebral column'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0919609', 'cui_str': 'Electroneuromyography'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}]",84.0,0.0368616,"In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%, p =0.008) and conductivity in peripheral sensory fibers.","[{'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Borodulina', 'Affiliation': 'Medical scientific educational center, Moscow state university named after M.V. Lomonosov, Moscow, Russia.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Badalov', 'Affiliation': 'Scientific practical center of medical and social rehabilitation named after L.I. Shvetsova, Moscow, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mukhina', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Gushcha', 'Affiliation': 'Scientific center of neurology, Moscow, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Marfina', 'Affiliation': 'Medical scientific educational center, Moscow state university named after M.V. Lomonosov, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Volovets', 'Affiliation': 'Scientific practical center of medical and social rehabilitation named after L.I. Shvetsova, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703135'] 3014,32592569,[Comparative evaluation of effectiveness of different magnetotherapy regimens in patients with osteoarthritis].,"Impulse low-frequency magnetotherapy is a modern method of treating diseases of the musculoskeletal system, including osteoarthritis. The effectiveness of the therapeutic effect largely depends on the biotropic characteristics of the magnetic fields - the type of magnetic field, induction, frequency, pulse shape, exposure, exposure zone. AIM OF STUDY To conduct a comparative analysis of effectiveness of applying various modes of magnetotherapy using an impulse low-frequency magnetic field in patients with osteoarthritis. MATERIALS AND METHODS A randomized, placebo-controlled clinical trial included 262 patients with grade II-III knee osteoarthritis according to the Kellgren-Lawrence classification. The 1st group included 56 patients who received local magnetic therapy on the knee using a running pulsed magnetic field (RPMF) - 20 mT, frequency 6.25 Hz, exposure time 20 min. The 2nd group included 99 patients who were exposed to a magnetic field using a combination of modes: 5 days - an impulse magnetic field (IMF) with induction of 2 mT, frequency of 100 Hz, then RPMF mode - 20 mT, frequency of 6.25 Hz, duration 20 min, number of procedures - 12. The third group included 97 patients who received placebo-magnetotherapy on the knee joint area. When analyzing the results, the VAS (100 mm) and WOMAC scales were used, as well as the subjective assessment of the treatment results by patients (5-point scale). RESULTS A pronounced symptom-modifying effect of magnetotherapy (according to VAS and WOMAC) was established in the form of a decrease in the severity of pain in patients with gonarthrosis ( p <0.01). There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01). The use of magnetotherapy using various modes is safe for patients and does not cause serious adverse events. CONCLUSION The application of magnetotherapy equipment, which allows the use of various biotropic characteristics of magnetic field, is an effective and safe technology for treatment of patients with osteoarthritis.",2020,"There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01).","['99 patients who were exposed to a', 'patients with osteoarthritis', '56 patients who received', '262 patients with grade II-III knee osteoarthritis according to the Kellgren-Lawrence classification']","['magnetic field using a combination of modes: 5 days - an impulse magnetic field (IMF', 'local magnetic therapy', 'magnetotherapy', 'placebo-magnetotherapy', 'magnetotherapy regimens', 'placebo']","['pain and stiffness indices', 'WOMAC scales', 'functional characteristics (WOMAC', 'severity of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0872210', 'cui_str': 'Magnetic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",262.0,0.0229588,"There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01).","[{'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Osnovina', 'Affiliation': 'Ivanovo State Medical Academy of the Ministry of Health of Russia, Ivanovo, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Alekseeva', 'Affiliation': 'Ivanovo State Medical Academy of the Ministry of Health of Russia, Ivanovo, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703143'] 3015,32592571,[Transcerebral magnetic and shock wave therapy in correction of erectile dysfunction].,"Given the complex pathogenesis of erectile dysfunction (ED), the inclusion of not only effective local physiotherapeutic effects, but also general physiotherapy methods into the treatment complexes of patients with ED is most justified. Transcerebral exposure to magnetic fields occupies a special place among them. AIM OF STUDY Development and scientific justification of a new complex physiotherapeutic method, including shock wave therapy (SVT) and transcerebral magnetotherapy, for the treatment of patients with ED. MATERIALS AND METHODS A prospective randomized study was carried out, which included 40 patients with a vasculogenic form of ED who underwent outpatient treatment at the Federal State Budget Scientific Institution «Research Center of the Republic of Kazakhstan» of the Ministry of Health of Russia. The 1st group (comparison) included 20 patients who received only 7 SVT procedures. The 2nd group (main) included 20 patients who received a comprehensive physiotherapeutic effect: topically - SVT (No. 7), transcerebral - running impulse magnetic field (No. 7). RESULTS As a result of course of SVT in combination with transcerebral magnetotherapy, the total score according to the IIEF-5 questionnaire in patients increased by 34.1% ( p <0.05), comparing with patients receiving only SVT (20.7%). In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%. It was found that the high clinical results of use of SVT in combination with transcerebral magnetotherapy are based on the compensation of local blood circulation, which manifests itself in eliminating the deficiency of blood supply by improving the tone of arterial vessels and eliminating venous stasis according to laser Doppler flowmetry (LDF). The inclusion of transcerebral magnetotherapy in the treatment complex helps to increase the level of total testosterone. CONCLUSION Higher therapeutic efficacy of the complex treatment of patients with ED using SVT and transcerebral magnetotherapy was revealed.",2020,"In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%.","['40 patients with a vasculogenic form of ED who underwent outpatient treatment at the Federal State Budget Scientific Institution «Research Center of the Republic of Kazakhstan» of the Ministry of Health of Russia', 'patients with ED', '20 patients who received a', '20 patients who received only 7 SVT procedures']","['comprehensive physiotherapeutic effect: topically - SVT (No. 7), transcerebral - running impulse magnetic field (No. 7', 'Transcerebral magnetic and shock wave therapy', 'shock wave therapy (SVT) and transcerebral magnetotherapy', 'SVT']","['IIEF-5 questionnaire', 'level of total testosterone', 'Goldstein scale', 'quality of hardness of erection', 'therapeutic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022537', 'cui_str': 'Kazakhstan'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0406353', 'cui_str': 'Multiple minute digitate hyperkeratosis of Goldstein'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0156503,"In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%.","[{'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Konchugova', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Kulchitskaya', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Kiyatkin', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Gushchina', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703160'] 3016,32592578,Efficacy of combined antigravity treadmill and conventional rehabilitation after hip fracture in patients with sarcopenia.,"BACKGROUND To compare long-term effects of antigravity treadmill (AGT) combined with conventional rehabilitation (CR) and CR after hip fracture in patients with sarcopenia. METHODS 45 patients were randomly allocated to AGT combined with CR (experimental group) or CR (control group) for 10 consecutive working days. Participants were evaluated prior to treatment, 3 weeks, 3 months, and 6 months after treatment. Outcome measurement included Koval walking ability scores functional ambulatory category (FAC), Berg Balance Scale (BBS), Korean version of Mini-Mental Status Examination, Euro Quality of Life Questionnaire Five-Dimensional Classification, Korean version of modified Barthel index, and grip strength. RESULTS At 3 weeks and 3 months, the comparison of change scores in KOVAL between two groups revealed difference of 0.84 (95% CI: -1.19, -0.49; p for trend = .000) and 1.21 (95% CI: -2.05, -0.36; p for trend = .006) respectively. At 3 weeks, comparison of change score in FAC between two groups revealed a difference of 0.73 (95% CI: 0.28, 1.19; p for trend = .003). The comparison of change scores between two groups also showed a difference in the 6 months in KOVAL and in the 3 months and 6 months in FAC. The comparison of changes in scores in BBS between two groups revealed difference of 11.63 (95% CI: 5.85, 17.40; p for trend = .001), 9.00 (95% CI: 2.28, 15.71; p for trend = .006), and 11.05 (95% CI: 3.62, 18.48; p for trend = .006) respectively at each follow-up. CONCLUSIONS Both groups were improved after intervention. As additional benefits were evident among those who carried out AGT, it may be appropriate for patients with sarcopenia after hip fracture surgery.",2020,"At 3 weeks, comparison of change score in FAC between two groups revealed a difference of 0.73 (95% CI: 0.28, 1.19; p for trend = .003).","['45 patients', 'patients with sarcopenia', 'patients with sarcopenia after hip fracture surgery']","['antigravity treadmill (AGT) combined with conventional rehabilitation (CR) and CR', 'combined antigravity treadmill and conventional rehabilitation', 'AGT combined with CR (experimental group) or CR (control group']","['Koval walking ability scores functional ambulatory category (FAC), Berg Balance Scale (BBS), Korean version of Mini-Mental Status Examination, Euro Quality of Life Questionnaire Five-Dimensional Classification, Korean version of modified Barthel index, and grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}]",45.0,0.125777,"At 3 weeks, comparison of change score in FAC between two groups revealed a difference of 0.73 (95% CI: 0.28, 1.19; p for trend = .003).","[{'ForeName': 'Min-Kyun', 'Initials': 'MK', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Jun-Il', 'Initials': 'JI', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Hayoung', 'Initials': 'H', 'LastName': 'Byun', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Se-Woong', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University Changwon Hospital, Samjeongjaro, Seongsan-gu, Changwon, Korea.'}, {'ForeName': 'Seung-Kyu', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University Changwon Hospital, Samjeongjaro, Seongsan-gu, Changwon, Korea.'}, {'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Jang', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Chang Han', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa158'] 3017,32592589,The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan.,"BACKGROUND The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial. METHODS The AID-ICU trial is a investigator-initiated, pragmatic, international, multicentre, randomised, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomisation. Secondary outcome measures are days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al. A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables. CONCLUSION The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.",2020,"Secondary outcome measures are days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation.","['delirium in acutely admitted, adult intensive care unit (ICU) patients', '1000 adult ICU patients with manifest delirium 1:1 to', 'acutely admitted, adult patients with manifest delirium in the ICU']","['haloperidol or placebo', 'haloperidol']","['days alive and out of hospital within 90 days post-randomisation', 'stratification variables (site and delirium motor subtype', 'days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1000.0,0.342267,"Secondary outcome measures are days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Andersen-Ranberg', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Lone M', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Camilla B', 'Initials': 'CB', 'LastName': 'Mortensen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Estrup', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Bjørn H', 'Initials': 'BH', 'LastName': 'Ebdrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research (CNSR) & Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Helsinki University Hospital, Department of Anaesthesiology, Helsinki, Finland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Citerio', 'Affiliation': 'Universitá Milano Bicocca, Monza, Italy.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Caballero', 'Affiliation': 'Hospital Universitari Arnau de Vilanova de Lleida, IRBLLeida, Departament de Medicina, Universitat Autònoma de Barcelona-UAB, Barcelona, Spain.'}, {'ForeName': 'Matthew P G', 'Initials': 'MPG', 'LastName': 'Morgan', 'Affiliation': 'Adult Critical Care, University of Wales, Cardiff, Wales.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Oxenbøll-Collet', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sven-Olaf', 'Initials': 'SO', 'LastName': 'Weber', 'Affiliation': 'General Intensive Care Unit, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Intensive Care Unit, Dept. of Anesthesiology and Intensive Care, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Helle B S', 'Initials': 'HBS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Nykøbing Falster Hospital, Nykøbing, Denmark.'}, {'ForeName': 'Louise G', 'Initials': 'LG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Intensive Care, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Uslu', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Troels B', 'Initials': 'TB', 'LastName': 'Jensen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Thee', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Sønderjylland, Aabenraa, Denmark.'}, {'ForeName': 'Nilanjan', 'Initials': 'N', 'LastName': 'Dey', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Unit West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13661'] 3018,32592596,The effects of vilaprisan on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive - A randomized controlled trial.,"AIM The primary objective was to explore whether the suppression of ovarian activity induced by a combined oral contraceptive (COC) is influenced by the simultaneous intake of the selective progesterone receptor modulator (SPRM) vilaprisan (VPR). METHODS In this exploratory randomized, double-blind, parallel-group study, 71 healthy premenopausal women were randomized (1:1) to receive either 2 mg/d VPR or placebo for 3 months. Concomitantly, a COC (0.15 mg levonorgestrel, 0.03 mg ethinylestradiol) was administered in a cyclic regimen. Ovarian activity (Hoogland score based on follicle size and hormone concentrations), cervical function (Insler score), bleeding pattern, and endometrial thickness/histology were assessed before treatment, in treatment cycle 3, and during follow-up. RESULTS The known COC-driven suppression of ovarian activity was mildly affected by VPR. COC+VPR group: 22%, 0%, and 6% of the subjects had Hoogland scores of 4 (active follicle-like structures), 5, or 6 (ovulation). COC+placebo group: 14% of the subjects had a score of 4 and none a score of 5 or 6 (Bayesian analysis for Hoogland score =4, median difference in response rate: 7.5% (90% credible interval [-8.5%; 23.5%])). COC-effects on cervical function were moderately affected (mucus more sperm-permeable under COC+VPR). COC withdrawal bleeding, in contrast, was absent in 81% of the subjects receiving COC+VPR vs 0% receiving COC+placebo. CONCLUSION The SPRM vilaprisan interfered with the pharmacodynamic effects of the COC. Therefore, full contraceptive effectiveness cannot be assumed without final judgment by a Pearl index study. Women on SPRMs should be advised to use non-hormonal contraception methods.",2020,COC-effects on cervical function were moderately affected (mucus more sperm-permeable under COC+VPR).,['71 healthy premenopausal women'],"['COC+VPR', 'COC+placebo', 'VPR or placebo', 'COC (0.15 mg levonorgestrel, 0.03 mg ethinylestradiol', 'vilaprisan', 'combined oral contraceptive (COC']","['cervical function', 'ovarian activity', 'COC withdrawal bleeding', 'response rate', 'Ovarian activity (Hoogland score based on follicle size and hormone concentrations), cervical function (Insler score), bleeding pattern, and endometrial thickness/histology', 'suppression of ovarian activity']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152010', 'cui_str': 'Withdrawal bleeding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",71.0,0.467656,COC-effects on cervical function were moderately affected (mucus more sperm-permeable under COC+VPR).,"[{'ForeName': 'Marcus-Hillert', 'Initials': 'MH', 'LastName': 'Schultze-Mosgau', 'Affiliation': 'Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, 13353, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schütt', 'Affiliation': 'Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, 13353, Berlin, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Draeger', 'Affiliation': 'dinox GmbH, Female Health Research, Berlin, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Casjens', 'Affiliation': 'CRS Clinical Research Services Berlin GmbH, Berlin, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Loewen', 'Affiliation': 'Early Development Statistics, Chrestos Concept GmbH & Co. KG, 45131, Essen, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, 13353, Berlin, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Rohde', 'Affiliation': 'Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, 13353, Berlin, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14443'] 3019,32592633,Effects of Multiple-Dose Administration of Aprocitentan on the Pharmacokinetics of Rosuvastatin.,"Aprocitentan is an investigational, orally active, dual, endothelin receptor antagonist that targets a novel pathway in the treatment of difficult-to-control (resistant) hypertension. The drug-drug interaction potential of aprocitentan on the breast cancer resistance protein (BCRP) transporter substrate rosuvastatin was investigated in this single-center, open-label, single-sequence study. Twenty healthy male subjects received a single dose of 10-mg rosuvastatin on days 1 and 13 followed by pharmacokinetic and tolerability assessments for up to 120 hours. From day 5 to day 17, subjects received 25 mg of aprocitentan once daily. Seventeen of 20 enrolled subjects completed the treatment. At steady state, aprocitentan did not affect the pharmacokinetics of rosuvastatin in a clinically relevant way. The maximum plasma concentration was increased by 40% with a 90% confidence interval of 1.19 to 1.65. However, the ratio of the geometric means for both area under the plasma concentration-time curve from time 0 to time t and area under the plasma concentration-time curve from time 0 to infinity was close to 1 with the 90% confidence interval within a reference interval of 0.80 to 1.25. Adverse events leading to study discontinuation were reported in 2 subjects. Overall, the combination of rosuvastatin and aprocitentan was well tolerated. Based on these data, aprocitentan does not affect BCRP and can be administered concomitantly with drugs dependent on BCRP transport.",2020,The maximum plasma concentration was increased by 40% with a 90% confidence interval of 1.19 to 1.65.,"['Seventeen of 20 enrolled subjects completed the treatment', 'Twenty healthy male subjects']","['10-mg rosuvastatin', 'rosuvastatin', 'Rosuvastatin']","['maximum plasma concentration', 'tolerated']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",20.0,0.0227631,The maximum plasma concentration was increased by 40% with a 90% confidence interval of 1.19 to 1.65.,"[{'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.815'] 3020,32592693,Physical Exam Indicated Cerclage in Twin pregnancy: a Randomized Controlled Trial.,"BACKGROUND Twin pregnancies with dilated cervix in the second trimester are at increased risk of pregnancy loss and early preterm birth; currently there is no proven therapy to prevent preterm birth in this group of women. OBJECTIVE To determine if physical exam indicated cerclage reduces the incidence of preterm birth in asymptomatic women with twin gestations and cervical dilation diagnosed before 24 weeks of pregnancy. STUDY DESIGN Multicenter, parallel-group, open-label, randomized controlled trial of women with twin pregnancy, and asymptomatic cervical dilation from 1-5 cm between 16 0/7 to 23 6/7 weeks were enrolled from 7/2015 to 7/2019 in 8 centers. Eligible women were randomized in a 1:1 ratio to either cerclage or no cerclage. We excluded women with: monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis. The primary outcome was the incidence of preterm birth <34 weeks. Secondary outcomes were preterm birth <32, <28 and <24 weeks, interval from diagnosis to delivery, and perinatal mortality. Data were analyzed as intention to treat. RESULTS After an interim analysis was performed, the Data Safety Monitoring Board recommended stopping the trial due to significant decrease of perinatal mortality in the cerclage group. We randomized 34 women, four were excluded due to expired informed consent. Seventeen women were randomized to physical exam indicated cerclage and 13 women to no cerclage. Four women randomized to cerclage did not receive the surgical procedure, while no women in the no cerclage group received cerclage. Maternal demographics were not significantly different. All women in the cerclage group also received indomethacin and antibiotics. When comparing cerclage vs no cerclage group, the incidence of preterm birth <34 weeks was significantly decreased: 12/17 (70%) vs 13/13 (100%) (RR: 0.71 95% CI 0.52-0.96), as well as preterm birth <32 weeks 11/17 (64.7%) vs 13/13 (100%) (RR: 0.65 95% CI 0.46-0.92), preterm birth <28 weeks 7/17 (41%) vs 11/13 (84%) (RR: 0.49 95% CI 0.26-0.89) and preterm birth <24 weeks 5/17 (30%) vs 11/13 (84%) (RR: 0.35 95% CI 0.16-0.75). The mean gestational age at delivery was later: 29.05±1.7 vs. 22.5±3.9 weeks (p<0.01); the mean interval from diagnosis of cervical dilation to delivery was longer: 8.3±5.8 vs. 2.9±3.0 weeks (p=0.02). Perinatal mortality was also significantly reduced in the cerclage group 6/34 (17.6%) vs 20/26 (77%), (RR: 0.22 95% CI 0.1-0.5). CONCLUSION A combination of physical exam indicated cerclage, indomethacin, and antibiotics in asymptomatic twin pregnancies before 24 weeks significantly decreases preterm birth at all evaluated gestational ages. Most importantly, cerclage in this population is associated with a 50% decrease in very early preterm birth <28 weeks and with a 78% decrease in perinatal mortality.",2020,"When comparing cerclage vs no cerclage group, the incidence of preterm birth <34 weeks was significantly decreased: 12/17 (70%) vs 13/13 (100%) (RR: 0.71 95% CI 0.52-0.96), as well as preterm birth <32 weeks 11/17 (64.7%) vs 13/13 (100%) (RR: 0.65 95% CI 0.46-0.92), preterm birth <28 weeks 7/17 (41%) vs 11/13 (84%) (RR: 0.49 95% CI 0.26-0.89) and preterm birth <24 weeks 5/17 (30%) vs 11/13 (84%) (RR: 0.35 95% CI 0.16-0.75).","['women with twin pregnancy, and asymptomatic cervical dilation from 1-5 cm between 16 0/7 to 23 6/7 weeks were enrolled from 7/2015 to 7/2019 in 8 centers', 'Seventeen women', 'women with: monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis', 'Eligible women', 'asymptomatic women with twin gestations and cervical dilation diagnosed before 24 weeks of pregnancy', 'Twin pregnancy', '34 women, four were excluded due to expired informed consent']","['cerclage', 'physical exam indicated cerclage and 13 women to no cerclage', 'cerclage or no cerclage', 'Physical Exam Indicated Cerclage', 'indomethacin and antibiotics', 'physical exam indicated cerclage, indomethacin, and antibiotics', 'physical exam indicated cerclage']","['incidence of preterm birth <34 weeks', 'perinatal mortality', 'incidence of preterm birth', 'mean interval from diagnosis of cervical dilation to delivery', 'preterm birth', 'mean gestational age at delivery', 'Perinatal mortality', 'preterm birth <32, <28 and <24 weeks, interval from diagnosis to delivery, and perinatal mortality', 'Maternal demographics']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C2909036', 'cui_str': 'Twin-to-twin blood transfer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0032046', 'cui_str': 'Placenta previa'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",34.0,0.350373,"When comparing cerclage vs no cerclage group, the incidence of preterm birth <34 weeks was significantly decreased: 12/17 (70%) vs 13/13 (100%) (RR: 0.71 95% CI 0.52-0.96), as well as preterm birth <32 weeks 11/17 (64.7%) vs 13/13 (100%) (RR: 0.65 95% CI 0.46-0.92), preterm birth <28 weeks 7/17 (41%) vs 11/13 (84%) (RR: 0.49 95% CI 0.26-0.89) and preterm birth <24 weeks 5/17 (30%) vs 11/13 (84%) (RR: 0.35 95% CI 0.16-0.75).","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roman', 'Affiliation': 'Maternal Fetal Medicine Division, Obstetrics and Gynecology Department, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, United States. Electronic address: amanda.roman@jefferson.edu.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Zork', 'Affiliation': 'Maternal Fetal Medicine Division, Obstetrics and Gynecology Department, Columbia University, New York, NY.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Haeri', 'Affiliation': ""St David's Women's Center of Texas, Austin Maternal-Fetal Medicine, Austin, TX.""}, {'ForeName': 'Corina N', 'Initials': 'CN', 'LastName': 'Schoen', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of Massachusetts-Baystate, Springfield, MA.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Colihan', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Albany Medical Center, Albany, NY.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Zelig', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Albany Medical Center, Albany, NY.'}, {'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'Gimovsky', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Seligman', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Maternal Fetal Medicine Division, Obstetrics and Gynecology Department, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, United States.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.047'] 3021,32592694,Delivery of monochorionic twins - lessons learned from the Twin Birth Study.,"BACKGROUND The current literature regarding the recommended mode of delivery in monochorionic-diamniotic (MCDA) twins is limited by small numbers, retrospective studies, and comparisons of outcomes of MCDA gestations to those of dichorionic-diamniotic (DCDA) gestations, instead of outcomes of trial of labor versus elective cesarean delivery for MCDA twins. OBJECTIVE To compare perinatal and maternal outcomes of planned-cesarean delivery and planned-vaginal delivery in MCDA twin pregnancies using the Twin Birth Study data. STUDY DESIGN A secondary analysis of the Twin Birth Study. Women were randomized at 32 0/7 to 38 6/7 weeks of gestation to planned cesarean section (CS) or planned vaginal delivery (VD). Inclusion criteria were twin A in the cephalic presentation, and estimated weight of each twin between 1500-4000 grams. Gestations complicated by fetal reduction after 13 weeks of gestation, lethal fetal anomaly or contraindication vaginal delivery were excluded. Elective delivery was planned between 37 5/7 and 38 6/7 weeks of gestation. Perinatal and maternal outcomes of MCDA gestations were compared between those randomized for planned CS and those randomized for planned VD. Additionally, outcomes of MCDA pregnancies were compared to those of DCDA pregnancies. RESULTS Out of the 1,393 women in each arm, 346 (24.9%) women in the planned CS arm and 324 (23.3%) women in the planned VD arm had MCDA twins and were eligible for the first analysis. The rate of CS in the planned VD arm was 39.2%, and in the planned CS arm was 91.3%. There was no significant difference in gestational age at delivery between the groups (34.4±1.8 weeks vs. 34.5±1.8 weeks, p=0.78). No difference in maternal outcomes was found. As for perinatal outcomes, the rate of the primary adverse neonatal composite outcome in twins A or twin B was similar in both the planned VD and the planned CS arms (Twins A: 1.2% vs. 1.2%, p=0.92, Twins B: 1.2% vs. 3.2%, p=0.09). Within the planned CS arm, the rate of primary adverse neonatal composite outcome was higher in twins B than twins A (3.2% vs. 1.2%, p=0.03). There was no difference in the primary adverse neonatal composite outcome between twins A in the MCDA group and the DCDA group (1.2% vs. 1.3%, P=0.89), nor between twins B (2.3% vs. 2.7%, P=0.47). CONCLUSION In MCDA twin pregnancy between 32 0/7 -38 6/7 weeks of gestation, with twin A in a cephalic presentation, planned cesarean delivery did not decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery.",2020,"There was no difference in the primary adverse neonatal composite outcome between twins A in the MCDA group and the DCDA group (1.2% vs. 1.3%, P=0.89), nor between twins B (2.3% vs. 2.7%, P=0.47). ","['Inclusion criteria were twin A in the cephalic presentation, and estimated weight of each twin between 1500-4000 grams', 'MCDA twin pregnancies using the Twin Birth Study data', 'Out of the 1,393 women in each arm, 346 (24.9%) women in the planned CS arm and 324 (23.3', 'women in the planned VD arm had MCDA twins and were eligible for the first analysis']","['planned-cesarean delivery and planned-vaginal delivery', 'DCDA', 'MCDA', 'gestation to planned cesarean section (CS) or planned vaginal delivery (VD']","['gestational age at delivery', 'primary adverse neonatal composite outcome', 'risk of fetal or neonatal death or serious neonatal morbidity', 'rate of CS', 'lethal fetal anomaly or contraindication vaginal delivery', 'maternal outcomes', 'rate of primary adverse neonatal composite outcome', 'rate of the primary adverse neonatal composite outcome in twins A or twin B']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C2977401', 'cui_str': 'Monochorionic diamniotic twin pregnancy'}, {'cui': 'C0233365', 'cui_str': 'Twin birth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}]",,0.227474,"There was no difference in the primary adverse neonatal composite outcome between twins A in the MCDA group and the DCDA group (1.2% vs. 1.3%, P=0.89), nor between twins B (2.3% vs. 2.7%, P=0.47). ","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Aviram', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. Electronic address: amiraviram25@gmail.com.'}, {'ForeName': 'Ms Hayley', 'Initials': 'MH', 'LastName': 'Lipworth', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Asztalos', 'Affiliation': 'Department of Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Mei-Dan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; Department of Obstetrics and Gynecology, North York General Hospital, University of Toronto, Toronto ON, Canada.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Melamed', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Xingshan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Research Design and Biostatistics, Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Zaltz', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Hvidman', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jon F R', 'Initials': 'JFR', 'LastName': 'Barrett', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.048'] 3022,32592912,In Vitro Evaluation of the Effectiveness of Bleaching Agents Activated by KTP and Nd:YAG laser.,"AIM To compare two different laser sources, a KTP laser with a wavelength of 532 nm and a Nd:YAG laser with a wavelength of 1064 nm, to investigate the relation between laser source and bleaching gel during laser irradiation. METHODS Extracted human teeth were stained and randomly divided into six groups. Two in-office bleaching gels, Beyond and Opalescence Boost, were applied to stained teeth and then irradiated at either 532 nm or 1064 nm. The temperature change of pulp chamber was measured. The color change (ΔE*) was evaluated at the following time points: immediately after bleaching, 7, 14 and 30 days after the end of bleaching. RESULTS Boost irradiated by KTP laser showed the higher temperature increase when compared with Beyond irradiated KTP and Nd:YAG. Boost irradiated by Nd:YAG presented lower temperature increase than by KTP. All groups showed a certain color change. After bleaching, Nd:YAG laser irradiation did not increase the ΔE* value significantly compared with gels without laser (p >  0.05). At each time point, Boost activated by KTP laser showed higher ΔE* value compared with other groups (p < 0.05), but decreased significantly 15 days after the end of bleaching. The other groups showed a relatively small change in ΔE* value after 30 days (p > 0.05). CONCLUSIONS KTP laser achieved better results than the Nd:YAG laser regarding tooth color change when associated with the Opalescence Boost bleaching gels.",2020,"After bleaching, Nd:YAG laser irradiation did not increase the ΔE* value significantly compared with gels without laser (p >  0.05).",['Extracted human teeth'],"['bleaching, Nd:YAG laser irradiation', 'KTP laser with a wavelength of 532\u2009nm and a Nd:YAG laser', 'Bleaching Agents Activated by KTP and Nd:YAG laser', 'Boost irradiated by Nd:YAG', 'KTP laser']",['temperature change of pulp chamber'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0392222', 'cui_str': 'Potassium titanyl phosphate laser device'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C2936259', 'cui_str': 'Whitening Agents'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}]","[{'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0034099', 'cui_str': 'Pulp chamber of tooth'}]",,0.0166658,"After bleaching, Nd:YAG laser irradiation did not increase the ΔE* value significantly compared with gels without laser (p >  0.05).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Taiyuan, China. Electronic address: d.du565@163.com.'}, {'ForeName': 'Zhuoping', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'School and Hospital of Stomatology, Shanxi Medical University, Taiyuan, China. Electronic address: 784246283@qq.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Taiyuan, China. Electronic address: 601564009@qq.com.'}, {'ForeName': 'Kuanshou', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Quantum Optics and Quantum Optics Devices, Institute of Opto-Electronics, Shanxi University, Taiyuan, China. Electronic address: kuanshou@sxu.edu.cn.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Taiyuan, China; School and Hospital of Stomatology, Shanxi Medical University, Taiyuan, China. Electronic address: liuqingmei2006@sina.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101900'] 3023,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM). METHODS A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated. RESULTS Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively. CONCLUSIONS The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively. ",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively. ","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024'] 3024,32592986,"A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer - The FALUCA study.","OBJECTIVES Fruquintinib is an orally active kinase inhibitor that selectively targets the vascular endothelial growth factor (VEGF) receptor. A Phase II trial has demonstrated a significant benefit in progression-free survival (PFS) for fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy. This Phase III trial is a randomized, double-blind, multicenter trial to confirm fruquintinib's efficacy in the same patient population. MATERIALS AND METHODS From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study. Participants were randomized 2:1 to receive fruquintinib (n = 354) or placebo (n = 173) once daily for 3 weeks on-treatment, and 1 week off-treatment. Patients were stratified according to epidermal growth factor receptor mutation status and prior use of VEGF inhibitors. Primary endpoint was overall survival (OS). RESULTS Median OS was 8.9 months for the fruquintinib group and 10.4 months for placebo group (hazard ratio [HR] 1.02; 95 % confidence interval [CI], 0.82-1.28; P = 0.841), with median PFS of 3.7 months and 1.0 months, respectively (HR 0.34; 95 % CI, 0.28-0.43; P < 0.001). Objective response rate and disease control rate were 13.8 % and 66.7 % for fruquintinib, and 0.6 % and 24.9 % for placebo, respectively (P < 0.001). Hypertension was the most frequent treatment-emergent adverse event (≥grade 3) observed in fruquintinib-treated patients (21.0 %). Post hoc analysis revealed that fruquintinib prolonged the median OS for patients who did not receive subsequent antitumor therapy: 7.0 months versus 5.1 months for placebo (HR 0.65; 95 % CI, 0.46-0.91; P = 0.012). Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires. CONCLUSION Although the study did not meet its primary endpoint, fruquintinib could be effective in combination with other agents for the treatment of patients with NSCLC who have failed second-line chemotherapy.",2020,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires. ","['patients with NSCLC who have failed second-line chemotherapy', 'Chinese patients with advanced nonsquamous non-small-cell lung cancer ', 'From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study', 'same patient population', 'fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy']",['placebo'],"['Objective response rate and disease control rate', 'Median OS', 'Hypertension', 'fruquintinib prolonged the median OS', 'quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires', 'progression-free survival (PFS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",730.0,0.694568,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires. ","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, China. Electronic address: shunlu@sjtu.edu.cn.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Harbin Medical University Cancer Hospital, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'XuZhou Central Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'The Second Hospital of Anhui Medical University, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Xiamen Key Laboratory of Antitumor Drug Transformation Research, The First Affiliated Hospital of Xiamen University, China.'}, {'ForeName': 'Junguo', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nantong Tumor Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Linyi Cancer Hospital, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""The Fifth Medical Center, General Hospital of the People's Liberation Army, China.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Cancer Hospital, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, China.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'The Second Xiangya Hospital of Central South University, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ""Jiangyin People's Hospital, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Hubei Cancer Hospital, China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'West China Hospital of Sichuan University, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Xinjiang Cancer Hospital, China.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Affiliated Hospital of Guangdong Medical University, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Jinling Hospital, Nanjing University School of Medicine, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Shanghai Changhai Hospital, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Northern Jiangsu People's Hospital, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Liaoning Cancer Hospital, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'General Hospital of Northern Theater Command, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'General Hospital of Ningxia Medical University, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Jie', 'Affiliation': ""The Fifth People's Hospital of Shanghai, China.""}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, China.'}, {'ForeName': 'Wangjun', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Nanfang Hospital of Southern Medical University, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital Affiliated with School of Medicine, Zhejiang University, China.'}, {'ForeName': 'Dongning', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'The Fourth Affiliated Hospital of Guangxi Medical University, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Hust, China.'}, {'ForeName': 'Jinji', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Guandong Provincial People's Hospital, China.""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, China.""}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Hangzhou First People's Hospital, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Peking University Third Hospital, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'The First Affiliated Hospital of Soochow University, China.'}, {'ForeName': 'Yijiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Hainan General Hospital, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, China.'}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Yunnan Cancer Hospital, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.016'] 3025,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK). METHOD The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting. RESULTS The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed. CONCLUSION Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005'] 3026,32593228,Development and evaluation of e-learning materials for dental hygiene students in six schools: using smartphones to learn dental treatment procedures.,"OBJECTIVE The purpose of this study was to develop and evaluate the effectiveness of using e-learning on smartphones to provide dental hygiene education on dental treatment procedures. METHODS This was a randomised controlled trial. Two-hundred ninety-three dental hygiene students in four universities, one junior college, and one technical school took a preliminary examination, and based on the results, participants in each school were randomly divided into two groups, a test or control group. Both groups took pre- and post-examinations at a 4-week interval. The test groups learned dental treatment procedures and four-handed techniques with interactive learning materials using smartphones. The learning materials allowed them to watch videos of dental treatments. The control groups were not provided any learning material. RESULTS Results of all schools combined showed that the changes from pre- to post-examination scores in the test groups were significantly higher than those of the control groups (p<0.05). Post-examination scores were significantly higher than pre-examination scores in the test groups in all schools (p<0.05). Also, post-examination scores of the test groups were significantly higher than those of the control groups (p<0.05). The changes from pre- to post-examination scores in the test groups of two schools were significantly higher than those of control groups (p<0.05). Post-examination scores of the control groups in two schools were significantly higher than pre-examination scores (p<0.05). CONCLUSIONS Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.",2020,"CONCLUSIONS Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.","['Two-hundred ninety-three dental hygiene students in four universities, one junior college, and one technical school took a preliminary examination, and based on the results, participants in each school', 'dental hygiene students in six schools']","['e-learning', 'learned dental treatment procedures and four-handed techniques with interactive learning materials using smartphones']","['pre- to post-examination scores', 'Post-examination scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0815244', 'cui_str': 'Interactive Learning'}, {'cui': 'C0449902', 'cui_str': 'Material used'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",293.0,0.0139299,"CONCLUSIONS Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takenouchi', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Etsuyo', 'Initials': 'E', 'LastName': 'Otani', 'Affiliation': 'Shinjuku Medical Career College, Tokyo, Japan.'}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Sunaga', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Curricular Management Division, Institute of Education, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Department of Oral Health Sciences, Faculty of Health Sciences, Osaka Dental University, Osaka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Uehara', 'Affiliation': 'Department of Oral Health, Kobe Tokiwa Junior College, Hyogo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Akiyama', 'Affiliation': 'Major of Oral Health Sciences, Department of Health Sciences, School of Health and Social Services, Saitama Prefectural University, Saitama, Japan.'}, {'ForeName': 'Takae', 'Initials': 'T', 'LastName': 'Kawashima', 'Affiliation': 'Shinjuku Medical Career College, Tokyo, Japan.'}, {'ForeName': 'Kanade', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Oral Care for Systemic Health Support, Health Sciences and Biomedical Engineering, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Izuno', 'Affiliation': ""Department of Oral Health Sciences, Faculty of Nursing and Health Care, BAIKA Women's University, Osaka, Japan.""}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Curricular Management Division, Institute of Education, Tokyo Medical and Dental University, Tokyo, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12452'] 3027,32593255,[Treatment of torpid trophic ulcers in patients of the older age group.],"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years. The application of the principles of regenerative medicine, actively developing, in the treatment of such diseases, is based on the use of both autologous blood derivatives and autologous mononuclear cells. Objective: to evaluate the effectiveness of the use of plasma enriched with platelets in the treatment of torpid ulcers of the lower extremities in patients of the older age group. A prospective, randomized clinical trial was conducted in 80 patients. According to preliminary calculations, it has been shown that the combination of traditional treatment with the introduction of plasma enriched with platelets leads to accelerated healing of ulcers.",2020,"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years.","['80 patients', 'patients of the older age group', 'torpid ulcers of the lower extremities in patients of the older age group']",[],['Chronic ulcers or non-healing ulcers'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",[],"[{'cui': 'C0333297', 'cui_str': 'Chronic ulcer'}, {'cui': 'C0205301', 'cui_str': 'Non-healed'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",1000.0,0.0160628,"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Smagin', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Shumkov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Soluianov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Demura', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Smagin', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Lykov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Nimaev', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}]",Advances in gerontology = Uspekhi gerontologii,[] 3028,32589319,Promoting parent-infant responsiveness in families experiencing homelessness.,"My Baby's First Teacher is an intervention designed specifically for parents with infants staying in emergency homeless shelters. Infants are overrepresented in shelter populations and face considerable risk to their development, including mental health. We utilized a randomized controlled design across three family shelters to evaluate the program's effectiveness with 24 dyads assigned to the intervention compared to 21 dyads in care-as-usual. Dyads were randomized by round at each site to account for shelter effects. We used path analysis to illustrate change over time and in relation to intervention assignment.",2020,My Baby's First Teacher is an intervention designed specifically for parents with infants staying in emergency homeless shelters.,"['families experiencing homelessness', 'parents with infants staying in emergency homeless shelters']",[],[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]",[],[],,0.0674091,My Baby's First Teacher is an intervention designed specifically for parents with infants staying in emergency homeless shelters.,"[{'ForeName': 'Janette E', 'Initials': 'JE', 'LastName': 'Herbers', 'Affiliation': 'Department of Psychological and Brain Sciences, Villanova University, Villanova, Pennsylvania.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Cutuli', 'Affiliation': 'Center for Healthcare Delivery Science, Nemours Biomedical Research, Rutgers University-Camden, Newark, Delaware.'}, {'ForeName': 'Perrin B', 'Initials': 'PB', 'LastName': 'Fugo', 'Affiliation': 'Department of Psychological and Brain Sciences, Villanova University, Villanova, Pennsylvania.'}, {'ForeName': 'Elke R', 'Initials': 'ER', 'LastName': 'Nordeen', 'Affiliation': 'Department of Psychological and Brain Sciences, Villanova University, Villanova, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Psychological and Brain Sciences, Villanova University, Villanova, Pennsylvania.'}]",Infant mental health journal,['10.1002/imhj.21868'] 3029,32589339,Feasibility of FitSurvivor: A technology-enhanced group-based fitness intervention for adolescent and young adult survivors of childhood cancer.,"BACKGROUND This study evaluated the feasibility of a technology-enhanced group-based fitness intervention for adolescent and young adult (AYA) survivors of childhood cancer. PROCEDURE AYA survivors ages 13-25 years were randomized to the intervention (eight in-person group sessions with mobile app and FitBit followed by 4 weeks of app and FitBit only) or waitlist control. Assessments were at 0, 2, 3, 6, and 9 months. Feasibility was evaluated by enrollment, retention, attendance, app engagement, and satisfaction. Secondary outcomes included physical activity, muscular strength/endurance, cardiorespiratory fitness, health-related quality of life, and fatigue. RESULTS A total of 354 survivors were mailed participation letters; 68 (19%) were screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible). Forty-nine survivors (M age  = 18.5 years, 49% female) completed baseline assessments and were randomized (25 intervention, 24 waitlist). Thirty-seven (76%) completed the postintervention assessment and 32 (65%) completed the final assessment. On average, participants attended 5.7 of eight sessions (range 1-8). Overall intervention satisfaction was high (M = 4.3, SD = 0.58 on 1-5 scale). Satisfaction with the companion app was moderately high (M = 3.4, SD = 0.97). The intervention group demonstrated significantly greater improvement in lower body muscle strength compared to the waitlist postintervention, and small but not statistically significant changes in other secondary measures. CONCLUSIONS A group-based intervention with a mobile app and fitness tracker was acceptable but has limited reach due to geographical barriers and competing demands experienced by AYA survivors.",2020,"The intervention group demonstrated significantly greater improvement in lower body muscle strength compared to the waitlist postintervention, and small but not statistically significant changes in other secondary measures. ","['Forty-nine survivors (M age \xa0', 'adolescent and young adult (AYA) survivors of childhood cancer', 'AYA survivors ages 13-25\xa0years', 'adolescent and young adult survivors of childhood cancer', 'A total of 354 survivors were mailed participation letters; 68 (19%) were screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible']","['FitSurvivor', 'intervention (eight in-person group sessions with mobile app and FitBit followed by 4\xa0weeks of app and FitBit only) or waitlist control', 'technology-enhanced group-based fitness intervention']","['Overall intervention satisfaction', 'physical activity, muscular strength/endurance, cardiorespiratory fitness, health-related quality of life, and fatigue', 'lower body muscle strength', 'retention, attendance, app engagement, and satisfaction', 'Satisfaction']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439175', 'cui_str': '% of total'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",354.0,0.0427851,"The intervention group demonstrated significantly greater improvement in lower body muscle strength compared to the waitlist postintervention, and small but not statistically significant changes in other secondary measures. ","[{'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Devine', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Viola', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Levonyan-Radloff', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Mackowski', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bozzini', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Chandler', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Baichen', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ohman-Strickland', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Mayans', 'Affiliation': 'Hackensack Meridian Health, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Farrar-Anton', 'Affiliation': 'Hackensack Meridian Health, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Olle Jane Z', 'Initials': 'OJZ', 'LastName': 'Sahler', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Masterson', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Manne', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Arent', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}]",Pediatric blood & cancer,['10.1002/pbc.28530'] 3030,32589342,Lottery incentives have short-term impact on ART initiation among men: results from a randomized pilot study.,"INTRODUCTION Among people living with HIV in South Africa, viral suppression is lower among men than women. The study aim was to test the impact of lottery incentives, which reward positive health choice (e.g. antiretroviral therapy (ART) linkage) with a chance to win a prize, on strengthening the HIV care continuum including ART initiation and viral suppression for men. METHODS We conducted a randomized, prospective trial of lottery incentives in the context of HIV testing and linkage to ART in rural KwaZulu-Natal, South Africa. Men living with HIV were randomly allocated to: lottery incentives and motivational text messages or motivational text messages only. Lottery prize eligibility was conditional on clinic registration, ART initiation, or viral suppression by one, three and six months respectively. After completing each continuum step, participants in the lottery group were notified whether they had won and were encouraged to continue in care. Lottery prizes were either a mobile phone, data or a gift card (valued at R1000/$100). Kaplan-Meier curves were plotted to determine time to ART initiation by study group. The primary outcome was viral suppression at six months. RESULTS Between November 2017 and December 2018, we tested 740 men for HIV and enrolled 131 HIV-positive men who reported not being on ART. At baseline, 100 (76%) participants were 30 years and older, 95 (73%) were unemployed and the median CD4 count was 472 cells/μL. At study exit, 84% (110/131) of participants had visited a clinic and 62% (81/131) were virally suppressed. Compared to motivational text messages, lottery incentives decreased the median time to ART initiation from 126 to 66 days (p = 0.0043, age-adjusted Cox regression) among all participants, and, from 134 days to 20 days (p = 0.0077) among participants who were not virally suppressed at baseline. Lottery incentives had an inconclusive effect on clinic registration (RR = 1.21, 95% CI: 0.83 to 1.76) and on viral suppression at six months (RR = 1.13, 95% CI: 0.73 to 1.75) compared to motivational text messages. CONCLUSIONS Conditional lottery incentives shortened the time to ART initiation among South African men. Behavioural economics strategies strengthen linkage to ART, but the study power was limited to see an impact on viral suppression. CLINICAL TRIAL NUMBER NCT03808194.",2020,"Compared to motivational text messages, lottery incentives decreased the median time to ART initiation from 126 to 66 days (p = 0.0043, age-adjusted Cox regression) among all participants, and, from 134 days to 20 days (p = 0.0077) among participants who were not virally suppressed at baseline.","['740 men for HIV and enrolled 131 HIV-positive men who reported not being on ART', 'people living with HIV in South Africa', 'South African men', 'Men living with HIV', 'Between November 2017 and December 2018', 'men', 'At baseline, 100 (76%) participants were 30\xa0years and older, 95 (73%) were unemployed and the median CD4 count was 472\xa0cells/μL', 'rural KwaZulu-Natal, South Africa']","['lottery incentives, which reward positive health choice (e.g. antiretroviral therapy (ART) linkage', 'lottery incentives and motivational text messages or motivational text messages only']","['median time to ART initiation', 'viral suppression', 'time to ART initiation', 'clinic registration']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",131.0,0.271571,"Compared to motivational text messages, lottery incentives decreased the median time to ART initiation from 126 to 66 days (p = 0.0043, age-adjusted Cox regression) among all participants, and, from 134 days to 20 days (p = 0.0077) among participants who were not virally suppressed at baseline.","[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'van Heerden', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Szpiro', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Meighan L', 'Initials': 'ML', 'LastName': 'Krows', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Torin T', 'Initials': 'TT', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thulani', 'Initials': 'T', 'LastName': 'Ngubane', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Rose B', 'Initials': 'RB', 'LastName': 'Nxele', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'van Rooyen', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25519'] 3031,32589354,Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial.,"INTRODUCTION Without significant increases in uptake of HIV testing among men, it will be difficult to reduce HIV incidence to disease elimination levels. Secondary distribution of HIV self-tests by women to their male partners is a promising approach for increasing male testing that is being implemented in several countries. Here, we examine male partner and couples testing outcomes and sexual decision making associated with this approach in a cluster randomized trial. METHODS We examined data from women at higher risk of HIV participating in the intervention arm of an ongoing pair-matched cluster randomized trial in Kenya. HIV-negative women ≥18 years who self-reported ≥2 partners in the past month were eligible. Participants received self-tests at enrolment and three-monthly intervals. They were encouraged to offer tests to sexual partners with whom they anticipated condomless sex. At six months, we collected data on self-test distribution, male partner and couples testing, and testing and sexual behaviour in the three most recent transactional sex encounters. We used descriptive analyses and generalized estimating equation models to understand how sexual behaviour was influenced by self-test distribution. RESULTS From January 2018 to April 2019, 921/1057 (87%) participants completed six-month follow-up. Average age was 28 years, 65% were married, and 72% reported income through sex work. Participants received 7283 self-tests over six months, a median of eight per participant. Participants offered a median three self-tests to sexual partners. Of participants with a primary partner, 94% offered them a self-test. Of these, 97% accepted the test. When accepted, couples testing was reported among 91% of participants. Among 1954 transactional sex encounters, 64% included an offer to self-test. When offered self-tests were accepted by 93% of partners, and 84% who accepted conducted couples testing. Compared to partners with an HIV-negative result, condom use was higher when men had a reactive result (56.3% vs. 89.7%, p < 0.01), were not offered a self-test (56.3% vs. 62.0%, p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). CONCLUSIONS Providing women with multiple self-tests facilitated male partner and couples testing, and led to safer sexual behaviour. These findings suggest secondary distribution is a promising approach for reaching men and has HIV prevention potential. Clinical Trial Number: NCT03135067.",2020,"p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). ","['women at higher risk of HIV participating in the intervention arm of an ongoing pair-matched cluster randomized trial in Kenya', 'HIV-negative women ≥18\xa0years who self-reported ≥2 partners in the past month were eligible', 'Of participants with a primary partner, 94% offered them a self-test', 'From January 2018 to April 2019, 921/1057 (87%) participants completed six-month follow-up', 'sexual partners with whom they anticipated condomless sex', '1954 transactional sex encounters, 64% included an offer to self-test', 'women to their male partners', 'Average age was 28\xa0years, 65% were married, and 72% reported income through sex work']",[],"['HIV self-tests', 'uptake of HIV testing', 'self-test distribution, male partner and couples testing, and testing and sexual behaviour']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0719497,"p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). ","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Napierala', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA, USA.""}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Bair', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Marcus', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Perez', 'Initials': 'P', 'LastName': 'Ochwal', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25515'] 3032,31807987,Safety and feasibility of inspiratory muscle training for hospitalized patients undergoing hematopoietic stem cell transplantation: a randomized controlled study.,"PURPOSE Patients undergoing hematopoietic stem cell transplantation (HSCT) usually experienced respiratory muscle weakness. Inspiratory muscle training (IMT) at HSCT has not been studied yet. Thus, it is important to evaluate the safety, feasibility, and preliminary effectiveness of IMT for hospitalized patients undergoing HSCT with an unstable and acute clinical condition. METHODS This is a randomized controlled feasibility study. Thirty-one hospitalized patients undergoing HSCT were randomized to the conventional physical rehabilitation (CON) or to the IMT group (conventional physical rehabilitation + IMT). IMT was carried out at 40% of maximal inspiratory pressure (MIP), 5 sessions weekly, 10-20 min/session. Primary outcomes were safety and feasibility (recruitment, adherence, and attrition rates) of IMT. Secondary outcomes were respiratory strength, respiratory rate, oxygen saturation, and frequency of patients with oxygen desaturation, bleeding, dyspnea, and acute pulmonary edema. RESULTS Patients were allocated to the IMT (N = 15; 43.6 years) or to the CON group (N = 16; 46.6 years). The recruitment rate was 100%, the adherence rate was 91%, and attrition was 13% to IMT. Two events were observed in 126 IMT sessions (1.5%). MIP increased in the IMT group (P < 0.01). No differences were observed in respiratory rate and oxygen saturation between groups. Trends to negative outcomes were observed in the CON in comparison to IMT group for a need of oxygen therapy (18% vs. 6%), bleeding (12% vs. 6%), dyspnea (25% vs. 13%), and acute pulmonary edema (6% vs. 0%). CONCLUSIONS IMT is safe, feasible, and improves the inspiratory muscle strength in hospitalized patients undergoing HSCT. TRIAL REGISTRATION Clinical trial registration: NCT03373526.",2020,MIP increased in the IMT group (P < 0.01).,"['Patients undergoing hematopoietic stem cell transplantation (HSCT) usually experienced respiratory muscle weakness', 'hospitalized patients undergoing HSCT', 'Thirty-one hospitalized patients undergoing HSCT', 'hospitalized patients undergoing HSCT with an unstable and acute clinical condition', 'hospitalized patients undergoing hematopoietic stem cell transplantation']","['Inspiratory muscle training (IMT', 'inspiratory muscle training', 'conventional physical rehabilitation (CON) or to the IMT group (conventional physical rehabilitation + IMT', 'CON', 'IMT']","['inspiratory muscle strength', 'safety and feasibility (recruitment, adherence, and attrition rates) of IMT', 'recruitment rate', 'adherence rate', 'MIP', 'acute pulmonary edema', 'bleeding', 'dyspnea', 'respiratory rate and oxygen saturation', 'respiratory strength, respiratory rate, oxygen saturation, and frequency of patients with oxygen desaturation, bleeding, dyspnea, and acute pulmonary edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1836141', 'cui_str': 'Respiratory muscle weakness'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0155919', 'cui_str': 'Acute pulmonary edema'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",31.0,0.0564342,MIP increased in the IMT group (P < 0.01).,"[{'ForeName': 'Leonardo Barbosa', 'Initials': 'LB', 'LastName': 'de Almeida', 'Affiliation': 'Federal University of Juiz de Fora, Cardiovascular Research Unit and Exercise Physiology, José Lourenço Kelmer, s/n, Martelos, Juiz de Fora, 36036-900, Brazil. almeidalb@hotmail.com.'}, {'ForeName': 'Patrícia Fernandes', 'Initials': 'PF', 'LastName': 'Trevizan', 'Affiliation': 'Federal University of Juiz de Fora, Cardiovascular Research Unit and Exercise Physiology, José Lourenço Kelmer, s/n, Martelos, Juiz de Fora, 36036-900, Brazil.'}, {'ForeName': 'Mateus Camaroti', 'Initials': 'MC', 'LastName': 'Laterza', 'Affiliation': 'Federal University of Juiz de Fora, Cardiovascular Research Unit and Exercise Physiology, José Lourenço Kelmer, s/n, Martelos, Juiz de Fora, 36036-900, Brazil.'}, {'ForeName': 'Abrahão Elias', 'Initials': 'AE', 'LastName': 'Hallack Neto', 'Affiliation': 'Department of Hematology, Hemotherapy and Bone Marrow Transplantation, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Ana Carolina Amaral de São José', 'Initials': 'ACASJ', 'LastName': 'Perrone', 'Affiliation': 'Department of Hematology, Hemotherapy and Bone Marrow Transplantation, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Daniel Godoy', 'Initials': 'DG', 'LastName': 'Martinez', 'Affiliation': 'Federal University of Juiz de Fora, Cardiovascular Research Unit and Exercise Physiology, José Lourenço Kelmer, s/n, Martelos, Juiz de Fora, 36036-900, Brazil.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05209-x'] 3033,31832821,Incidence of peripheral neuropathy associated with eribulin mesylate versus vinorelbine in patients with metastatic breast cancer: sub-group analysis of a randomized phase III study.,"BACKGROUND Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most significant neurologic complications of chemotherapy, impacting patient's behavior and quality of life. CIPN is mostly sensory, with rare incidences of autonomic dysfunction and other neuropathy. METHODS We conducted a single-center sub-group analysis of patients with metastatic breast cancer enrolled in a phase III study (NCT02225470) set up to compare eribulin mesylate (1.4 mg/m 2 on days 1 and 8 every 21 days) with vinorelbine (25 mg/m 2 on days 1, 8, and 15 every 21 days). The analysis investigated incidence of peripheral neuropathy, time to onset of neuropathy, and safety. RESULTS Our analysis included 110 women with a mean age of 50.7 (SD = 10.9). The median accumulated dose of eribulin was 11.2 mg/m 2 and 125.0 mg/m 2 for vinorelbine. Among patients in the eribulin group, a performance status (ECOG PS) of 2 was correlated with peripheral sensory neuropathy (p = 0.015), and accumulated eribulin dose (≥ 10 mg/m 2 ) was associated with all neuropathy and peripheral sensory neuropathy (p = 0.003 and p = 0.007, respectively). In the vinorelbine group, patient age (≥ 65 years) was positively associated with all neuropathy (p = 0.043). The time to onset of neuropathy appeared to be longer for eribulin versus vinorelbine (35.3 vs. 34.6 weeks; p = 0.046), with a significantly higher incidence of autonomic neuropathy at weeks 2 and 10 observed among patients receiving vinorelbine (p = 0.008 and p = 0.043, respectively). CONCLUSION Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer. Furthermore, the onset of neurotoxicity appears to occur earlier with vinorelbine than eribulin.",2020,Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer.,"['patients with metastatic breast cancer', '110 women with a mean age of 50.7 (SD = 10.9', 'patients with metastatic breast cancer enrolled in a phase III study (NCT02225470) set up to compare eribulin mesylate ']","['Vinorelbine', 'vinorelbine', 'eribulin mesylate versus vinorelbine']","['performance status (ECOG PS', 'autonomic neuropathy', 'peripheral neuropathy, time to onset of neuropathy, and safety', 'peripheral sensory neuropathy', 'time to onset of neuropathy', 'neuropathy and peripheral sensory neuropathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",110.0,0.0360162,Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Changzheng Hospital, Second Military Medical University, Shanghai, 200003, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Biyun', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China. xchu2009@hotmail.com.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05112-5'] 3034,31834519,Effects of ginger adjunct to the standard prophylaxis on reducing carboplatin and paclitaxel-induced nausea vomiting: a randomized controlled study.,"PURPOSE To determine effects of ginger on reducing the severity of nausea and/or vomiting among gynecologic cancer patients receiving a combined carboplatin-paclitaxel regimen. METHODS The research was a randomized, double-blinded, crossover, placebo-controlled trial. Participants were patients with gynecologic malignancies receiving carboplatin-paclitaxel chemotherapy at King Chulalongkorn Memorial Hospital. Either ginger (2 g per day) or placebo was prescribed in adjunct to standard antiemetic prophylaxis, in alternated cycles between groups: in group 1, ginger was prescribed in odd cycles and placebo in even cycles and vice versa in group 2. Patients with gut obstruction or brain or bowel metastasis, those using anticoagulants or other ginger or antiemetic medications, or patients who had ginger allergy were excluded from the study. Statistics were analyzed by STATA version 15.1. RESULTS Overall, 47 participants were recruited. Mean age was 53.9 years. Seventeen subjects were chemotherapy-naïve. In an acute phase of nausea, ginger therapy significantly reduced the mean nausea score comparing to placebo (P = 0.03). However, in the delayed phase, there were no significant differences between groups. For the acute and delayed phase of vomiting, there was no difference between the groups. No serious adverse effects were demonstrated in the ginger group (P > 0.05). CONCLUSION Adjunct ginger therapy on standard nausea and vomiting prophylaxis protocol especially in day 1 has benefit in reducing an acute phase nausea in patients receiving a combined carboplatin-paclitaxel regimen. The benefit on delayed phase nausea and vomiting is still equivocal.",2020,"In an acute phase of nausea, ginger therapy significantly reduced the mean nausea score comparing to placebo (P = 0.03).","['patients receiving a combined carboplatin-paclitaxel regimen', 'gynecologic cancer patients receiving a combined carboplatin-paclitaxel regimen', 'Patients with gut obstruction or brain or bowel metastasis, those using anticoagulants or other ginger or antiemetic medications, or patients who had ginger allergy were excluded from the study', '47 participants were recruited', 'Seventeen subjects were chemotherapy-naïve', 'at King Chulalongkorn Memorial Hospital', 'Participants were patients with gynecologic malignancies receiving', 'Mean age was 53.9 years']","['carboplatin and paclitaxel', 'carboplatin-paclitaxel chemotherapy', 'placebo']","['nausea vomiting', 'nausea and/or vomiting', 'mean nausea score', 'vomiting', 'acute phase nausea', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",47.0,0.284531,"In an acute phase of nausea, ginger therapy significantly reduced the mean nausea score comparing to placebo (P = 0.03).","[{'ForeName': 'Apiradee', 'Initials': 'A', 'LastName': 'Uthaipaisanwong', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Shina', 'Initials': 'S', 'LastName': 'Oranratanaphan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand. dr_shina@hotmail.com.'}, {'ForeName': 'Natdanai', 'Initials': 'N', 'LastName': 'Musigavong', 'Affiliation': 'Department of Pharmacy, Chaophya Abhaibhubejhr Hospital, Prachin Buri, Thailand.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05201-5'] 3035,31885802,"Salivary and Plasmatic Antioxidant Profile following Continuous, Resistance, and High-Intensity Interval Exercise: Preliminary Study.","The increase in antioxidant responses promoted by regular physical activity is strongly associated with the attenuation of chronic oxidative stress and physiological mechanisms related to exercise adaptation. The aim of this work was to evaluate and compare how different exercise protocols (HIIE: high-intensity interval exercise, CE: continuous exercise, and RE: resistance exercise) may alter salivary and plasmatic antioxidants and salivary markers of exercise intensity and nitric oxide. Thirteen healthy, trained male subjects were submitted to the three exercise protocols. Blood and saliva samples were collected at the points preexercise, postexercise, and 3 hours postexercise. Antioxidants (total antioxidant capacity, superoxide dismutase and catalase activities, and levels of reduced glutathione and uric acid), markers of exercise intensity (salivary total protein and amylase activity), and salivary nitric oxide were evaluated. As a result, all exercise protocols increased the markers of exercise intensity and nitric oxide. Antioxidant response was increased after exercise, and it was found that a single HIIE session exerts a similar pattern of antioxidant response compared to CE, in plasma and saliva samples, while RE presented minor alterations. We suggest that HIIE may lead to alterations in antioxidants and consequently to the physiological processes related to redox, similar to the CE, with the advantage of being performed in a shorter time. In addition, the antioxidant profile of saliva samples showed to be very similar to that of plasma, suggesting that saliva may be an alternative and noninvasive tool in sports medicine for the study of antioxidants in different physical exercise protocols.",2019,"Antioxidants (total antioxidant capacity, superoxide dismutase and catalase activities, and levels of reduced glutathione and uric acid), markers of exercise intensity (salivary total protein and amylase activity), and salivary nitric oxide were evaluated.","['Thirteen healthy, trained male subjects']","['exercise protocols (HIIE: high-intensity interval exercise, CE: continuous exercise, and RE: resistance exercise']","['Blood and saliva samples', 'Antioxidants (total antioxidant capacity, superoxide dismutase and catalase activities, and levels of reduced glutathione and uric acid), markers of exercise intensity (salivary total protein and amylase activity), and salivary nitric oxide', 'Antioxidant response', 'exercise intensity and nitric oxide', 'antioxidant responses']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",13.0,0.0483585,"Antioxidants (total antioxidant capacity, superoxide dismutase and catalase activities, and levels of reduced glutathione and uric acid), markers of exercise intensity (salivary total protein and amylase activity), and salivary nitric oxide were evaluated.","[{'ForeName': 'Adriele V', 'Initials': 'AV', 'LastName': 'Souza', 'Affiliation': 'Institute of Biotechnology, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Jéssica S', 'Initials': 'JS', 'LastName': 'Giolo', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Renata R', 'Initials': 'RR', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Biotechnology, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Vilela', 'Affiliation': 'Institute of Biotechnology, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Peixoto', 'Affiliation': 'Institute of Biotechnology, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Allisson B', 'Initials': 'AB', 'LastName': 'Justino', 'Affiliation': 'Institute of Biotechnology, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Caixeta', 'Affiliation': 'Institute of Biotechnology, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Federal University of Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Foued S', 'Initials': 'FS', 'LastName': 'Espindola', 'Affiliation': 'Institute of Biotechnology, Federal University of Uberlandia, Minas Gerais, Brazil.'}]",Oxidative medicine and cellular longevity,['10.1155/2019/5425021'] 3036,31602582,"Mu-Suppression as an Indicator of Empathic Processes in Lesbian, Gay, and Heterosexual Adults.","Self-reported empathy differs with gender and sexual orientation. The current study investigated whether mu-suppression, reflecting brain activity especially related to state empathy, also is modulated by gender and sexual orientation. Pictures of painful and non-painful actions were presented to 20 lesbians, 20 gay men, 20 heterosexual men and 20 heterosexual women, while EEG was recorded. Individual peak frequencies of mu-activity (electrodes C3, C4) were detected within the 6-11 Hz band for each participant, and mu-suppression indices were calculated. Further, verbal indicators of state empathy (pain ratings) and compassion were assessed. Only heterosexual individuals showed the typical pattern of enhanced mu-suppression in response to painful relative to non-painful pictures. Lesbian women and gay men did not show a differential mu-response. Moreover, they felt less compassion compared to heterosexual individuals. In line with this finding, the more compassion the participants reported, the stronger the mu-suppression in response to painful relative to non-painful pictures was. Pain ratings did not vary with sexual orientation. The lesser compassion reported by lesbian women and gay men is discussed as a mediator of their non-differential mu-suppression response. It is hypothesized that this pattern might relate to gay men and lesbian women tending to perceive the anonymous depicted actors as outgroup members, hence showing less compassion and reduced mu-suppression. As empathy is often related to negative feelings (empathic stress), a clear distinction between individuals to empathize with versus individuals not to emphasize with may well be an adaptive feature in same-sex oriented individuals.",2020,Only heterosexual individuals showed the typical pattern of enhanced mu-suppression in response to painful relative to non-painful pictures.,"['20 gay men, 20 heterosexual men and 20 heterosexual women, while EEG was recorded', 'Lesbian women and gay men']",[],"['verbal indicators of state empathy (pain ratings) and compassion', 'Individual peak frequencies of mu-activity (electrodes C3, C4', 'Pain ratings']","[{'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}]",[],"[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",20.0,0.0155958,Only heterosexual individuals showed the typical pattern of enhanced mu-suppression in response to painful relative to non-painful pictures.,"[{'ForeName': 'Katrin T', 'Initials': 'KT', 'LastName': 'Lübke', 'Affiliation': 'Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany. katrin.luebke@uni-duesseldorf.de.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sachse', 'Affiliation': 'Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hoenen', 'Affiliation': 'Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Bettina M', 'Initials': 'BM', 'LastName': 'Pause', 'Affiliation': 'Department of Experimental Psychology, Heinrich-Heine-University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.'}]",Archives of sexual behavior,['10.1007/s10508-019-01491-2'] 3037,32589455,Virtual Reality Aids Game Navigation: Evidence from the Hypertext Lostness Measure.,"Instead of traditional free movement, node-based movement can be used in virtual reality (VR) games. In node-based movement systems, players navigate by jumping to set locations. Node-based movement is similar to hypertext navigation. We show that the hypertext lostness measure can be used as a game analytic to evaluate navigational efficiency. In a randomized controlled trial with 25 adolescent participants, an immersive desktop game environment and a VR game environment were compared on the transmission of in-game educational content and navigational efficiency. Results show that the hypertext lostness measure is also valuable outside its original hypertext domain: in VR. VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency. We conclude (a) the hypertext lostness measure is also valuable for node-based VR games and (b) VR games add to spatial learning, even when compared with already immersive desktop games.",2020,"VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency.",['25 adolescent participants'],['immersive desktop game environment and a VR game environment'],"[""players' spatial knowledge and navigational efficiency"", ""players' retention of factual knowledge""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",25.0,0.0146821,"VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ferguson', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Egon L', 'Initials': 'EL', 'LastName': 'van den Broek', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Herre', 'Initials': 'H', 'LastName': 'van Oostendorp', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'de Redelijkheid', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Giezeman', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2019.0435'] 3038,32589501,Implementing Automated Triggers to Identify Hospitalized Patients with Possible Unmet Palliative Needs: Assessing the Impact of This Systems Approach on Clinicians.,"Background: Understanding patients' goals and values is important to ensure goal-concordant care; however, such discussions can be challenging. Little is known about the impact of having these discussions on hospitalists. Objective: To assess the impact on hospitalists of a system that reminds them to have serious illness conversations with their patients identified with potential unmet palliative needs. Design: Two group cohort trial. Setting/Subjects: Single academic center. Internal medicine hospitalist physicians, nurse practitioners, and physician's assistants. Measurements: Before the trial, all participants received serious illness conversation training. During the trial, hospitalists on intervention units received verbal notification when their recently admitted patients were identified using a computer algorithm as having possible unmet palliative needs. Hospitalists on the control unit received no notifications. At baseline and three months, hospitalists completed questionnaires regarding communication skill acquisition, perception of the importance of these conversations, and sense of the meaning gained from having them. Results: Both groups had similar improvements in their self-reported communication skills and experienced a small decline in how important they felt the conversations were. Neither group perceived having the discussions as being affectively harmful to patients. The intervention hospitalists, over time, reported a slight reduction in the sense of meaning they achieved from the conversations. Conclusion: Routinely informing hospitalists when their patients were identified as being at increased risk for unmet palliative needs did not increase the sense of meaning these providers achieved. It is likely the pretrial training accounted for many of the positive outcomes in communication skills observed in both arms of the trial.",2020,Both groups had similar improvements in their self-reported communication skills and experienced a small decline in how important they felt the conversations were.,"['Hospitalized Patients with Possible Unmet', ""Internal medicine hospitalist physicians, nurse practitioners, and physician's assistants""]",['serious illness conversation training'],"['communication skill acquisition, perception of the importance of these conversations, and sense of the meaning gained from having them']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0600620', 'cui_str': 'Hospitalist'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",,0.0407718,Both groups had similar improvements in their self-reported communication skills and experienced a small decline in how important they felt the conversations were.,"[{'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Greenwald', 'Affiliation': 'Core Educator Faculty, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Gace', 'Affiliation': 'Hospital Medicine Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Sommer', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Bethany-Rose', 'Initials': 'BR', 'LastName': 'Daubman', 'Affiliation': 'Division of Palliative Care and Geriatric Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Leah B', 'Initials': 'LB', 'LastName': 'Rosenberg', 'Affiliation': 'Division of Palliative Care and Geriatric Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'LaSala', 'Affiliation': 'Department of Nursing, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Palliative Care and Geriatric Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0161'] 3039,32589506,"Treatment with Volanesorsen, a 2'-O-Methoxyethyl-Modified Antisense Oligonucleotide Targeting APOC3 mRNA, Does Not Affect the Corrected QT Interval in Healthy Volunteers.","The aim of this study was to assess the effect of volanesorsen on the corrected QT (QTc) interval. This thorough QT study enrolled 52 healthy male and female subjects who were randomized at a single site in a four-way crossover study. Subjects were randomly assigned to 1 of 12 treatment sequences and crossed over into four treatment periods over the course of which each subject was to receive a single therapeutic dose of volanesorsen as a 300 mg subcutaneous (SC) injection, a single supratherapeutic dose of volanesorsen as 300 mg intravenous (IV) infusion, a single oral (PO) dose of moxifloxacin (positive control), and placebo dose. The study demonstrated that volanesorsen 300 mg SC and 300 mg IV did not have a clinically relevant effect on ΔΔQTcF exceeding 10 ms. The largest mean effect at any postdose time point was 3.0 ms (90% confidence interval [CI]: 0.8-5.2) after SC dosing and 1.8 ms (90% CI -0.4 to 4.0) after IV dosing. Volanesorsen, at the studied therapeutic and supratherapeutic doses, does not have a clinically meaningful effect on the QTc.",2020,"Volanesorsen, at the studied therapeutic and supratherapeutic doses, does not have a clinically meaningful effect on the QTc.","['Healthy Volunteers', '52 healthy male and female subjects']","['volanesorsen as a 300\u2009mg subcutaneous (SC) injection, a single supratherapeutic dose of volanesorsen as 300\u2009mg intravenous (IV) infusion, a single oral (PO) dose of moxifloxacin (positive control), and placebo', 'volanesorsen 300\u2009mg SC', 'volanesorsen']","['Corrected QT Interval', 'corrected QT (QTc) interval', 'ΔΔQTcF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4726970', 'cui_str': 'Volanesorsen'}, {'cui': 'C0100700', 'cui_str': 'A 300'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",52.0,0.214881,"Volanesorsen, at the studied therapeutic and supratherapeutic doses, does not have a clinically meaningful effect on the QTc.","[{'ForeName': 'Lynnetta M', 'Initials': 'LM', 'LastName': 'Watts', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Karwatowska-Prokopczuk', 'Affiliation': 'Clinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Hurh', 'Affiliation': 'Clinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.'}, {'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Alexander', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Balogh', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': ""O'Dea"", 'Affiliation': 'Clinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Clinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.'}]",Nucleic acid therapeutics,['10.1089/nat.2019.0837'] 3040,32589554,Discontinuing cannabis improves depression in people with multiple sclerosis: A short report.,"To assess whether symptoms of depression change when people with multiple sclerosis (pwMS) discontinue cannabis use, 40 cognitively impaired pwMS who smoked cannabis almost daily were randomly assigned to either a cannabis continuation (CC) or cannabis withdrawal (CW) group. Both groups were followed for 28 days. All participants completed the Hospital Anxiety and Depression Scale. At day 28 the 11-nor-9-carboxy-Δ 9 -tetrahydro-cannabinol (THCCOOH)/creatinine ratio in the CW group declined to zero ( p  = 0.0001), but remained unchanged in the CC group ( p  = 0.709). Depression scores in those pwMS who were using cannabis to manage their depression remained statistically unchanged in the CC group, but declined in the CW group ( p  = 0.006). Despite pwMS using cannabis to help their mood, depression improved significantly off the drug. Our finding provides a cautionary note in relation to cannabis use in pwMS, at least with respect to depression.",2020,"Depression scores in those pwMS who were using cannabis to manage their depression remained statistically unchanged in the CC group, but declined in the CW group ( p  = 0.006).","['people with multiple sclerosis', 'people with multiple sclerosis (pwMS) discontinue cannabis use, 40 cognitively impaired pwMS who smoked cannabis almost daily']","['cannabis continuation (CC) or cannabis withdrawal (CW', 'Discontinuing cannabis']","['Depression scores', 'depression', 'Hospital Anxiety and Depression Scale', '11-nor-9-carboxy-Δ 9 -tetrahydro-cannabinol (THCCOOH)/creatinine ratio']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C3845713', 'cui_str': 'Nearly every day'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0006865', 'cui_str': 'Cannabinol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0700418,"Depression scores in those pwMS who were using cannabis to manage their depression remained statistically unchanged in the CC group, but declined in the CW group ( p  = 0.006).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Sunnybrook Health Sciences Centre, Division of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Sunnybrook Health Sciences Centre, Division of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Stefan', 'Affiliation': 'Clinical Laboratory and Diagnostic Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'W Richard', 'Initials': 'WR', 'LastName': 'Staines', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520934070'] 3041,32589613,Cognitive enhancement of healthy older adults using hyperbaric oxygen: a randomized controlled trial.,"More than half of community-dwelling individuals sixty years and older express concern about declining cognitive abilities. The current study's aim was to evaluate hyperbaric oxygen therapy (HBOT) effect on cognitive functions in healthy aging adults.A randomized controlled clinical trial randomized 63 healthy adults (>64) either to HBOT(n=33) or control arms(n=30) for three months. Primary endpoint included the general cognitive function measured post intervention/control. Cerebral blood flow (CBF) was evaluated by perfusion magnetic resonance imaging.There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017). The most striking improvements were in attention (net effect size=0.745) and information processing speed (net effect size=0.788).Voxel-based analysis showed significant cerebral blood flow increases in the HBOT group compared to the control group in the right superior medial frontal gyrus (BA10), right and left supplementary motor area (BA6), right middle frontal gyrus (BA6), left middle frontal gyrus (BA9), left superior frontal gyrus (BA8) and the right superior parietal gyrus (BA7).In this study, HBOT was shown to induce cognitive enhancements in healthy aging adults via mechanisms involving regional changes in CBF. The main improvements include attention, information processing speed and executive functions, which normally decline with aging.",2020,There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017).,"['63 healthy adults (>64) either to HBOT(n=33) or control arms(n=30) for three months', 'healthy older adults', 'healthy aging adults']","['hyperbaric oxygen', 'hyperbaric oxygen therapy (HBOT']","['global cognitive function post-HBOT', 'attention, information processing speed and executive functions, which normally decline with aging', 'Cerebral blood flow (CBF', 'right and left supplementary motor area (BA6), right middle frontal gyrus (BA6), left middle frontal gyrus (BA9), left superior frontal gyrus (BA8', 'cognitive functions', 'general cognitive function measured post intervention/control', 'cerebral blood flow increases']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",63.0,0.0790879,There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017).,"[{'ForeName': 'Hadanny', 'Initials': 'H', 'LastName': 'Amir', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Daniel-Kotovsky', 'Initials': 'DK', 'LastName': 'Malka', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Suzin', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Boussi-Gross', 'Initials': 'BG', 'LastName': 'Rahav', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Catalogna', 'Initials': 'C', 'LastName': 'Merav', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Dagan', 'Initials': 'D', 'LastName': 'Kobi', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Hachmo', 'Initials': 'H', 'LastName': 'Yafit', 'Affiliation': 'Research and Development Unit, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Abu Hamed', 'Initials': 'AH', 'LastName': 'Ramzia', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Sasson', 'Initials': 'S', 'LastName': 'Efrat', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Fishlev', 'Initials': 'F', 'LastName': 'Gregory', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Erez', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Polak', 'Initials': 'P', 'LastName': 'Nir', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Doenyas', 'Initials': 'D', 'LastName': 'Keren', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Friedman', 'Initials': 'F', 'LastName': 'Mony', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Sigal', 'Affiliation': 'Radiology Department, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Zemel', 'Initials': 'Z', 'LastName': 'Yonatan', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Bechor', 'Initials': 'B', 'LastName': 'Yair', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Efrati', 'Initials': 'E', 'LastName': 'Shai', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}]",Aging,['10.18632/aging.103571'] 3042,32589738,"A Phase 2, Multicenter Study of Nevanimibe for the Treatment of Congenital Adrenal Hyperplasia.","CONTEXT Patients with classic congenital adrenal hyperplasia (CAH) often require supraphysiologic glucocorticoid doses to suppress ACTH and control androgen excess. Nevanimibe hydrochloride (ATR-101), which selectively inhibits adrenal cortex function, might reduce androgen excess independent of ACTH and thus allow for lower glucocorticoid dosing in CAH. 17-hydroxyprogesterone (17-OHP) and androstenedione are CAH biomarkers used to monitor androgen excess. OBJECTIVE Evaluate the efficacy and safety of nevanimibe in subjects with uncontrolled classic CAH. DESIGN This was a multicenter, single-blind, dose-titration study. CAH subjects with baseline 17-OHP ≥ 4x the upper limit of normal (ULN) received the lowest dose of nevanimibe for 2 weeks followed by a single-blind 2-week placebo washout. Nevanimibe was gradually titrated up if the primary outcome measure (17-OHP ≤ 2x ULN) was not met. A total of 5 nevanimibe dose levels were possible (125, 250, 500, 750, 1000 mg twice daily). RESULTS The study enrolled 10 adults: 9 completed the study, and 1 discontinued early due to a related serious adverse event. At baseline, the mean age was 30.3±13.8 years, and the maintenance glucocorticoid dose, expressed as hydrocortisone equivalents was 24.7±10.4 mg/day. Two subjects met the primary endpoint, and 5 others experienced 17-OHP decreases ranging from 27-72% during nevanimibe treatment. The most common side effects were gastrointestinal (30%). There were no dose-related trends in adverse events. CONCLUSIONS Nevanimibe decreased 17-OHP levels within 2 weeks of treatment. Larger studies of longer duration are needed to further evaluate its efficacy as add-on therapy for CAH.",2020,"There were no dose-related trends in adverse events. ","['CAH subjects with baseline 17-OHP ≥ 4x the upper limit of normal (ULN', 'Congenital Adrenal Hyperplasia', 'subjects with uncontrolled classic CAH', 'The study enrolled 10 adults', 'Patients with classic congenital adrenal hyperplasia (CAH']","['nevanimibe', 'Nevanimibe', '17-hydroxyprogesterone', 'Nevanimibe hydrochloride (ATR-101', 'placebo']","['efficacy and safety', '17-OHP', 'adverse events', '17-OHP levels']","[{'cui': 'C0001627', 'cui_str': 'Congenital adrenal hyperplasia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202075', 'cui_str': '17 Hydroxyprogesterone measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C3831455', 'cui_str': 'ATR-101'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202075', 'cui_str': '17 Hydroxyprogesterone measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.044986,"There were no dose-related trends in adverse events. ","[{'ForeName': 'Diala', 'Initials': 'D', 'LastName': 'El-Maouche', 'Affiliation': 'The National Institutes of Health Clinical Center, Bethesda, MD; Division of Endocrinology & Metabolism, George Washington University, Washington, DC.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Merke', 'Affiliation': 'The National Institutes of Health Clinical Center, Bethesda, MD; Division of Endocrinology & Metabolism, George Washington University, Washington, DC.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Vogiatzi', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Alice Y', 'Initials': 'AY', 'LastName': 'Chang', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Adina F', 'Initials': 'AF', 'LastName': 'Turcu', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Joyal', 'Affiliation': 'The National Institutes of Health Clinical Center, Bethesda, MD; Division of Endocrinology & Metabolism, George Washington University, Washington, DC.'}, {'ForeName': 'Vivian H', 'Initials': 'VH', 'LastName': 'Lin', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, MI.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Weintraub', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, MI.'}, {'ForeName': 'Marianne R', 'Initials': 'MR', 'LastName': 'Plaunt', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, MI.'}, {'ForeName': 'Pharis', 'Initials': 'P', 'LastName': 'Mohideen', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, MI.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Auchus', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, MI.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa381'] 3043,32589828,"Oral Administration of S-Adenosylmethionine (SAMe) and Lactobacillus Plantarum HEAL9 Improves the Mild-To-Moderate Symptoms of Depression: A Randomized, Double-Blind, Placebo-Controlled Study.","Objective To assess the effects of the combination of SAMe (S-adenosylmethionine) 200 mg and Lactobacillus plantarum (L. plantarum) HEAL9 1 × 10⁹ CFU for the overall symptomatology of mild-to-moderate depression. Methods This 6-week randomized, double-blind, placebo-controlled study included subjects aged 18-60 years with mild-to-moderate depression (according to ICD-10 diagnostic criteria) recruited from September 17, 2018, to October 5, 2018. Difference between groups in change from baseline to treatment week 6 on the Zung Self-Rating Depression Scale (Z-SDS) was the primary outcome. Comparisons between groups in change from baseline to treatment week 2 of the Z-SDS and from baseline to treatment weeks 2 and 6 of other scales (related to insomnia, anxiety, irritable bowel syndrome, and health status) were also analyzed. Results Ninety patients were randomized to SAMe plus L. plantarum HEAL9 (n = 46) or placebo (n = 44) groups. A greater reduction for the new combination compared to placebo was seen at treatment week 6 in the Z-SDS total score (P = .0165) and the core depression subdomain (P = .0247). A significant reduction in favor of the combination was shown at treatment week 2 for the Z-SDS total score (P = .0330), the cognitive and anxiety subdomains (P = .0133 and P = .0459, respectively), and the anxiety questionnaire (P = .0345). No treatment-related adverse events occurred. Conclusions Supplementation of SAMe and L. plantarum HEAL9 in adults with subthreshold or mild-to-moderate symptoms of depression resulted in fast and clinically relevant effects after 2 weeks. The combination was safe and significantly improved symptoms of depression, anxiety, and cognitive and somatic components. The effect of this novel product is independent from the severity of the symptoms unlike traditional antidepressants available on the market that have minimal benefits for subthreshold or mild-to-moderate symptoms. Trial Registration ClinicalTrials.gov identifier: NCT03932474.",2020,A greater reduction for the new combination compared to placebo was seen at treatment week 6 in the Z-SDS total score (P = .0165) and the core depression subdomain (P = .0247).,"['adults with subthreshold or mild-to-moderate symptoms of depression', 'Ninety patients', 'subjects aged 18-60 years with mild-to-moderate depression (according to ICD-10 diagnostic criteria) recruited from September 17, 2018, to October 5, 2018']","['SAMe plus L. plantarum HEAL9', 'Placebo', 'S-Adenosylmethionine (SAMe) and Lactobacillus Plantarum HEAL9', 'HEAL9', 'SAMe (S-adenosylmethionine) 200 mg and Lactobacillus plantarum (L. plantarum', 'placebo']","['anxiety questionnaire', 'cognitive and anxiety subdomains', 'Zung Self-Rating Depression Scale', 'insomnia, anxiety, irritable bowel syndrome, and health status', 'Z-SDS total score', 'symptoms of depression, anxiety, and cognitive and somatic components']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",90.0,0.332771,A greater reduction for the new combination compared to placebo was seen at treatment week 6 in the Z-SDS total score (P = .0165) and the core depression subdomain (P = .0247).,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Saccarello', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Montarsolo', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Ivano', 'Initials': 'I', 'LastName': 'Massardo', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Picciotto', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pedemonte', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castagnaro', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Pier Claudio', 'Initials': 'PC', 'LastName': 'Brasesco', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Guida', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Picco', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Pino', 'Initials': 'P', 'LastName': 'Fioravanti', 'Affiliation': 'Hippocrates Research SRL, Genova, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Montisci', 'Affiliation': 'Hippocrates Research SRL, Genova, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schiavetti', 'Affiliation': 'Hippocrates Research SRL, Via XX Settembre, 30/12, 16121 Genova, Italy. i.schiavetti@hippocrates-research.it.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Vanelli', 'Affiliation': 'Nutrilinea SRL, Varese, Italy.'}]",The primary care companion for CNS disorders,['10.4088/PCC.19m02578'] 3044,32589851,"Six-month follow-up of a mindfulness yoga program, MiYoga, on attention, executive function, behaviour and physical outcomes in cerebral palsy.","Purpose: A randomised controlled trial (RCT) of a mindfulness-based yoga program, MiYoga, for cerebral palsy (CP) demonstrated improved attention in children and decreased mindfulness in parents post-intervention. This paper evaluates the retention of treatment effects at 6-months follow-up. Methods: 42 children with CP and their parents participated in a RCT with two groups MiYoga ( n  = 21) and Waitlist control group ( n  = 21). Waitlist control participants were offered MiYoga following the post-intervention assessment. 23 out of 42 child-parent dyads from both groups completed follow-up assessment 6-months after completing MiYoga. This paper evaluates and reports data from both groups collapsed ( n  = 23; MiYoga n  = 11; and waitlist control n  = 12; 47.8% male; mean age = 9:10 ± 2.4 years) to assess retention from post-MiYoga to follow-up and pre-MiYoga to follow-up. The primary outcome was attention, measured by Conner's Continuous Performance Test II (CCPT). Secondary outcomes included child executive function, physical function, behaviour, quality of life, child and parent mindfulness, personal wellbeing, psychological wellbeing and parent-child relationship. Results: Paired t -tests showed no significant changes between post-MiYoga to follow-up and pre-MiYoga to follow-up for variables that showed an intervention effect immediately after MiYoga, namely, children's attention variables and parent's mindfulness. Paired t -tests showed that children's executive function and physical function and parent's wellbeing improved significantly from pre-MiYoga to 6-months follow-up which may potentially reflect sleeper or delayed effects of MiYoga. Conclusion: This study identified possible delayed or sleeper effects in children's executive function and physical function and parent's well-being.Implications for rehabilitation6-month follow-up evidence for retention of effects of MiYoga on children's attention was inconsistent; therefore, booster sessions or continued practice of MiYoga as a lifestyle option are needed to maintain an effect on attention.Because MiYoga can be practised during daily activities, it may provide additional support for children with CP, complementing standard rehabilitation options.By embedding mindfulness in children and parents' daily activities, MiYoga, could provide families with accessible and time-efficient means of learning and practicing mindfulness.",2020,"Paired t -tests showed no significant changes between post-MiYoga to follow-up and pre-MiYoga to follow-up for variables that showed an intervention effect immediately after MiYoga, namely, children's attention variables and parent's mindfulness.","['children with CP', 'groups collapsed ( n \u2009=\u200923; MiYoga n \u2009=\u200911; and waitlist control n \u2009=\u200912; 47.8% male; mean age = 9:10\u2009±\u20092.4 years) to assess retention from post-MiYoga to follow-up and pre-MiYoga to follow-up', 'cerebral palsy', '42 children with CP and their parents participated in a RCT with two groups MiYoga ( n \u2009=\u200921) and Waitlist control group ( n \u2009=\u200921', 'children and decreased mindfulness in parents post-intervention']","['mindfulness-based yoga program, MiYoga, for cerebral palsy (CP']","[""attention, measured by Conner's Continuous Performance Test II (CCPT"", ""children's executive function and physical function and parent's wellbeing"", 'child executive function, physical function, behaviour, quality of life, child and parent mindfulness, personal wellbeing, psychological wellbeing and parent-child relationship']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1384514', 'cui_str': 'Primary aldosteronism'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031206', 'cui_str': 'Personal wellbeing status'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}]",42.0,0.032408,"Paired t -tests showed no significant changes between post-MiYoga to follow-up and pre-MiYoga to follow-up for variables that showed an intervention effect immediately after MiYoga, namely, children's attention variables and parent's mindfulness.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mak', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC), The University of Queensland Child Health Research Centre (UQ-CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC), The University of Queensland Child Health Research Centre (UQ-CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Cunnington', 'Affiliation': 'School of Psychology, The University of Queensland, Saint Lucia, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chatfield', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC), The University of Queensland Child Health Research Centre (UQ-CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC), The University of Queensland Child Health Research Centre (UQ-CHRC), The University of Queensland, Brisbane, Australia.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1783582'] 3045,32589857,Relationship between interleukin-13 rs20541 single nucleotide polymorphisms and therapeutic efficacy in children with asthma.,"OBJECTIVE To investigate the relationship between therapeutic efficacy in children with asthma and interleukin-13 (IL-13) rs20541 polymorphisms. METHODS Fifty children with moderate-to-severe asthma were assigned to the GG, GA, and AA groups according to the IL-13 gene locus rs20541 polymorphism. The patients received budesonide inhalation suspension 1 mg twice daily combined with fluticasone propionate 80 µg/inhalation. The improvement of clinical symptoms (gasping, coughing, and wheezing), improvement of lung function, and adverse reactions were observed. RESULTS Lung function did not significantly differ among three groups before treatment. After treatment, the time to symptom relief was significantly shorter in the GG group than that in the other two groups. The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups. CONCLUSION Budesonide inhalation suspension combined with fluticasone propionate is an effective treatment regimen for moderate-to-severe asthma. Polymorphism of the IL-13 rs20541 locus may be correlated with therapeutic efficacy. Patients carrying the GG allele were more responsive than their counterparts with the GA or AA allele.",2020,"The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups. ","['moderate-to-severe asthma', 'children with asthma', 'children with asthma and interleukin-13 (IL-13) rs20541 polymorphisms', 'Fifty children with moderate-to-severe asthma']","['budesonide inhalation suspension 1 mg twice daily combined with fluticasone propionate 80 µg/inhalation', 'fluticasone propionate']","['time to symptom relief', 'clinical symptoms (gasping, coughing, and wheezing), improvement of lung function, and adverse reactions', 'forced expiratory volume', 'Lung function', 'peak expiratory flow']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C4745751', 'cui_str': 'Budesonide Inhalation Suspension'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0425449', 'cui_str': 'Gasping for breath'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]",50.0,0.0209337,"The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups. ","[{'ForeName': 'Lixiao', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Yue', 'Affiliation': 'Jinan Maternity and Child Care Hospital, Shandong, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520929179'] 3046,32590520,"Radiographical Comparison of Superior and Inferior Gluteal Vessels in ""Jackknife"" Versus Prone Positions: A Prospective, Self-Controlled Trial.","BACKGROUND Mortality after gluteal augmentation with fat transfer techniques is extremely high. Placement of fat subcutaneously versus in the gluteal musculature, or both, are considerably debated. The purpose of this study was to radiographically show the anatomical difference in live subjects in different procedural positions: the flexed or ""Jack-knife"" versus prone positions. METHODS A total of ten females underwent Computerized Tomography (CT) scanning of the pelvis with venous phase run-off in both the ""Jack-knife"" and prone positions. A CT specialized radiologist then reviewed images and measured distances from the inferior and superior gluteal veins (IGV and SGV, respectively) to the skin and muscle. Three-dimensional (3D) imaging and analysis were also performed. RESULTS Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions. 3D modeling showed a significant reduction in the volume and SGV and IGV diameters when in the ""Jack-knife"" position. CONCLUSIONS When placed in the ""Jack-knife"" position for gluteal augmentation with fat transfer, extreme caution should be taken with the injecting cannula as the underlying muscle is only 2-3 centimeters deep. 3D analysis showed narrowed and reduced volume of gluteal vasculature when in the ""Jack-knife"" position; a possible indication of torsion or stretch on the vessel around the pelvic rim that could cause vein avulsion injury from the pressurized fat within the piriform space.",2020,"RESULTS Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","['Jackknife"" Versus Prone Positions']","['Computerized Tomography (CT) scanning', 'flexed or ""Jack-knife"" versus prone positions']","['volume of gluteal vasculature', 'volume and SGV and IGV diameters']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",10.0,0.0267786,"RESULTS Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","[{'ForeName': 'Connor W', 'Initials': 'CW', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Rajendra P', 'Initials': 'RP', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'Thanh Q', 'Initials': 'TQ', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Karlnoski', 'Affiliation': ''}, {'ForeName': 'Summer J', 'Initials': 'SJ', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007151'] 3047,32590521,"""Effect of cyclic compressive forces on new bone formation during the distraction period in andibular distraction osteogenesis using a Microactuator-Generated Distractor"".","BACKGROUND The traditional method of distraction procedure required a long period of time until the new bone was fully fused. This study aimed to evaluate the effect of cyclic and repetitive compressive force on new bone formation by applying newly designed microactuator-generated distractor comparing with the traditional distraction protocol. METHODS The distraction devices were applied to the right and left mandibles of eight mature beagles, one of which was allocated as the experimental group and the other as the control group. After a 5-day latency period, the experimental group alternately applied 1.5 mm distraction and 0.5 mm compression every 12 hours, and the control group repeated 0.5 mm distraction every 12 hours to perform a total of 7 mm mandibular lengthening. After an 8-week consolidation period, microstructure analysis using micro-computed tomography and histological evaluations were performed. RESULTS Bone volume fraction and trabecular number were significantly higher in the experimental group. Trabecular thickness did not show a significant difference. And trabecular separation was significantly higher in the control group. The measurement of new bone area showed significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant. CONCLUSIONS This study has revealed that applying cyclic compressive and tensile forces during the distraction period induces better new bone formation than repetitive distraction alone. In addition, the new distraction device produced reliable distraction results during the experiment.",2020,"The measurement of new bone area showed significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant. ",[],"['cyclic compressive forces', 'cyclic and repetitive compressive force']","['mineral apposition rate', 'measurement of new bone area', 'new bone formation', 'Bone volume fraction and trabecular number', 'Trabecular thickness', 'And trabecular separation']",[],"[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0036679', 'cui_str': 'Separation'}]",,0.0166226,"The measurement of new bone area showed significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant. ","[{'ForeName': 'Hyun-Jin', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Jung-Yul', 'Initials': 'JY', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Jong-Tae', 'Initials': 'JT', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyung Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007152'] 3048,32590542,"Comment on ""ALPPS Improves Survival Compared with TSH in Patients Affected of CRLM Survival Analysis from the Randomized Controlled Trial LIGRO"": Metastatic Tumor Burden in the Future Liver Remnant for Decision-Making of Staged Hepatectomy.",,2020,,[],['TSH'],[],[],"[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",[],,0.227437,,"[{'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': 'Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan Department of General Surgery and Chang Gung Transplantation Institute, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Yu-Chao', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Tsung-Han', 'Initials': 'TH', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Chih-Hsien', 'Initials': 'CH', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Chen-Fang', 'Initials': 'CF', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ting-Jung', 'Initials': 'TJ', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Hong-Shiue', 'Initials': 'HS', 'LastName': 'Chou', 'Affiliation': ''}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004017'] 3049,32590545,"Response to comment on ""ALPPS Improves Survival Compared With TSH in Patients Affected of CRLM: Survival Analysis From the Randomized Controlled Trial LIGRO-Metastatic Tumor Burden in the Future Liver Remnant for Decision-making of Staged Hepatectomy"".",,2020,,[],['TSH'],[],[],"[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",[],,0.210928,,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hasselgren', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Sweden Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Norway Department of Surgical Gastroenterology and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden Department of Surgery, Skane University Hospital, Lund, Sweden Department of Surgical Gastroenterology and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Norway Department of Surgery, Akademiska University Hospital, Uppsala, Sweden Department of Surgery and Clinical and Experimental Medicine, Linköping University, Sweden Department of Transplantation and Liver Surgery, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Department of Surgery and Clinical and Experimental Medicine, Linköping University, Sweden Department of Surgery and Clinical and Experimental Medicine, Linköping University, Sweden.'}, {'ForeName': 'Bård I', 'Initials': 'BI', 'LastName': 'Røsok', 'Affiliation': ''}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Sparrelid', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Lindell', 'Affiliation': ''}, {'ForeName': 'Nicolai A', 'Initials': 'NA', 'LastName': 'Schultz', 'Affiliation': ''}, {'ForeName': 'Bjorn A', 'Initials': 'BA', 'LastName': 'Bjørnbeth', 'Affiliation': ''}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Isaksson', 'Affiliation': ''}, {'ForeName': 'Anna Lindhoff', 'Initials': 'AL', 'LastName': 'Larsson', 'Affiliation': ''}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rizell', 'Affiliation': ''}, {'ForeName': 'Bergthor', 'Initials': 'B', 'LastName': 'Björnsson', 'Affiliation': ''}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sandström', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004014'] 3050,32590555,"In response to: A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL).",,2020,,"['patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0272434', 'cui_str': 'Injury of chest wall'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",[],[],,0.017272,,"[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Elkbuli', 'Affiliation': 'Department of Surgery, Division of Trauma and Surgical Critical Care, Kendall Regional Medical Center, Miami, FL, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Baroutjian', 'Affiliation': 'Department of Surgery, Division of Trauma and Surgical Critical Care, Kendall Regional Medical Center, Miami, FL, USA.'}, {'ForeName': 'Shaikh', 'Initials': 'S', 'LastName': 'Hai', 'Affiliation': 'Department of Surgery, Division of Trauma and Surgical Critical Care, Kendall Regional Medical Center, Miami, FL, USA.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002845'] 3051,32590653,Keeping the Finger on the Pulse: Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia with Adrenaline.,"BACKGROUND The wide-awake local anesthesia no tourniquet (WALANT) technique in hand surgery is gaining popularity. The authors aimed to prospectively analyze the frequency and type of arrhythmias in patients undergoing hand surgery under local anesthesia and to examine whether the addition of adrenaline affects their incidence. METHODS Adult patients undergoing hand surgery under local anesthesia were randomized into two groups: group 1, local anesthesia with lidocaine and tourniquet; and group 2, local anesthesia with lidocaine and adrenaline (WALANT). Patients with a history of arrhythmias were excluded. Patients were connected to Holter electrocardiographic monitoring before surgery and up until discharge. The records were blindly compared between the groups regarding types of arrhythmias, and frequency and timing relative to injection and tourniquet inflation. RESULTS One hundred two patients were included between August of 2018 and August of 2019 (age, 59.7 ± 13.6 years; 71 percent women; 51 in each group). No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group. Minor arrhythmias (including atrial premature beats, ventricular premature beats, and atrial tachycardia) were recorded in 68 patients (66.6 percent), with no statistical difference between the groups. There were three patients with minor arrhythmias during inflation of the tourniquet. Patients in the adrenaline group had 2 percent sinus tachycardia during injection and 4 percent asymptomatic bradyarrhythmias. These findings do not require any further treatment. CONCLUSIONS The authors' results show that hand operations using WALANT technique in patients with no history of arrhythmia are safe and are not arrhythmogenic; therefore, there is no need for routine perioperative continuous electrocardiographic monitoring. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.",2020,"No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group.","['One hundred two patients were included between August of 2018 and August of 2019 (age, 59.7 ± 13.6 years; 71 percent women; 51 in each group', 'Patients with a history of arrhythmias were excluded', 'Adult patients undergoing hand surgery under local anesthesia', 'patients undergoing hand surgery under local anesthesia']","['adrenaline', 'Adrenaline', 'local anesthesia with lidocaine and tourniquet; and group 2, local anesthesia with lidocaine and adrenaline (WALANT']","['Minor arrhythmias (including atrial premature beats, ventricular premature beats, and atrial tachycardia', 'sinus tachycardia', 'major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0039239', 'cui_str': 'Sinus tachycardia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",3.0,0.0466821,"No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group.","[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Farkash', 'Affiliation': 'Ashdod and Beer-Sheva, Israel From the Hand Surgery Unit, the Department of Orthopedic Surgery, and the Electrophysiology and Pacing Unit, Cardiology Department, Assuta Ashdod University Hospital; and the Faculty of Health Sciences, Ben-Gurion University of the Negev.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': ''}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Kalimian', 'Affiliation': ''}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Segal', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Avishag', 'Initials': 'A', 'LastName': 'Laish-Farkash', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006902'] 3052,32590658,Feasibility of Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching to Reduce Fistula Incidence following Cleft Palate Repair: A Pilot Trial.,"BACKGROUND Improving surgeons' technical performance may reduce their frequency of postoperative complications. The authors conducted a pilot trial to evaluate the feasibility of a surgeon-delivered audit and feedback intervention incorporating peer surgical coaching on technical performance among surgeons performing cleft palate repair, in advance of a future effectiveness trial. METHODS A nonrandomized, two-arm, unblinded pilot trial enrolled surgeons performing cleft palate repair. Participants completed a baseline audit of fistula incidence. Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique. All others were allocated to simple feedback (receiving audit results). Outcomes assessed were proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention. RESULTS Seven surgeons enrolled in the trial. All seven completed the baseline audit and disclosed their fistula incidence to other participants. The median baseline fistula incidence was 0.4 percent (range, 0 to 10.5 percent). Two surgeons were unable to receive the feedback intervention. Of the five remaining surgeons, two were allocated to intensive feedback and three to simple feedback. All surgeons completed their assigned feedback intervention. Among surgeons receiving intensive feedback, fistula incidence was 5.9 percent at baseline and 0.0 percent following feedback (adjusted OR, 0.98; 95 percent CI, 0.44 to 2.17). CONCLUSION Surgeon-delivered audit and feedback incorporating peer coaching on technical performance was feasible for surgeons.",2020,"Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique.","['Participants with a fistula incidence above the median', 'Cleft Palate Repair', 'Seven surgeons enrolled in the trial', 'surgeons performing cleft palate repair']","['Surgeon-delivered audit and feedback incorporating peer coaching', 'intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique', 'Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching', 'surgeon-delivered audit and feedback intervention incorporating peer surgical coaching', 'cleft palate repair']","['median baseline fistula incidence', 'proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention', 'Fistula Incidence', 'fistula incidence']","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0192086', 'cui_str': 'Repair of cleft palate'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0192086', 'cui_str': 'Repair of cleft palate'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2.0,0.216518,"Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Sitzman', 'Affiliation': ""Phoenix and Scottsdale, Ariz.; Seattle, Wash.; Durham, N.C.; Toronto and London, Ontario, Canada; Hershey, Pa.; and Akron and Cincinnati, Ohio From the Division of Plastic Surgery, Phoenix Children's Hospital; the Department of Surgery, Mayo Clinic College of Medicine; the Americleft Task Force Surgeon Subgroup; the Divisions of Craniofacial and Plastic Surgery and Plastic Surgery, Department of Surgery, Seattle Children's Hospital; the Division of Plastic, Maxillofacial & Oral Surgery, Duke University Hospital & Children's Health Center; the Cleft Lip and Palate Program, Division of Plastic Surgery, The Hospital for Sick Children; the Department of Surgery, University of Toronto; the Departments of Surgery, Pediatrics, and Neurosurgery, Penn State Hershey Medical Center; the Barrow Cleft and Craniofacial Center; the Division of Plastic and Reconstructive Surgery, Division of Paediatric Surgery, and the Department of Paediatrics, University of Western Ontario; Akron Children's Hospital; and the James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine.""}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Tse', 'Affiliation': ''}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Allori', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Samson', 'Affiliation': ''}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Beals', 'Affiliation': ''}, {'ForeName': 'Damir B', 'Initials': 'DB', 'LastName': 'Matic', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Marcus', 'Affiliation': ''}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ''}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Britto', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006907'] 3053,32590726,Prediction of no-reflow phenomenon in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.,"No-reflow is an important complication among patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).A retrospective study of 1658 STEMI patients undergoing direct PCI was performed. Patients were randomly assigned at a 7:3 ratio into development cohort and validation cohort and into no-reflow and normal blood flow groups. Clinical data and laboratory examinations were compared to identify independent risk factors and establish a no-reflow risk scoring system.In the development cohort (n = 1122), 331 (29.5%) had no-reflow. Multivariate analysis showed age ≥ 65 years (OR = 1.766, 95% confidence interval (CI): 1.313-2.376, P < .001), not using angiotonase inhibitor/angiotensin receptor antagonists (OR = 1.454, 95%CI: 1.084-1.951, P = .013), collateral circulation 8 mmol/L (OR = 1.386, 95%CI: 1.007-1.908, P = .045) were related to no-reflow. Receiver operating characteristic (ROC) area under the curve was 0.648 (95%CI: 0.609-0.86). At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%, P < .001. The resulting risk scoring system was tested in the validation cohort (n = 536), with 30.1% incidence of no-reflow. The area under the ROC curve was 0.637 (95%CI: 0.582-0.692). At a cutoff of 0.349 sensitivity was 53.2% and specificity was 66.7%, PPV was 41.2%, NPV was 76.4%, P < .001.The no-reflow risk scoring system was effective in identifying high-risk patients.",2020,"At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%,","['patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction', 'patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).A retrospective study of 1658 STEMI patients undergoing']",['direct PCI'],"['positive predictive value (PPV', 'risk scoring system', 'thrombosis aspiration', 'negative predictive value (NPV', 'Receiver operating characteristic (ROC) area under the curve', 'collateral circulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0009348', 'cui_str': 'Collateral circulation'}]",1658.0,0.10574,"At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%,","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Cong', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Tianjin Medical University.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Thoracic Clinical College, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}]",Medicine,['10.1097/MD.0000000000020152'] 3054,32590758,"Efficacy of deep convolutional neural network algorithm for the identification and classification of dental implant systems, using panoramic and periapical radiographs: A pilot study.","Convolutional neural networks (CNNs), a particular type of deep learning architecture, are positioned to become one of the most transformative technologies for medical applications. The aim of the current study was to evaluate the efficacy of deep CNN algorithm for the identification and classification of dental implant systems.A total of 5390 panoramic and 5380 periapical radiographic images from 3 types of dental implant systems, with similar shape and internal conical connection, were randomly divided into training and validation dataset (80%) and a test dataset (20%). We performed image preprocessing and transfer learning techniques, based on fine-tuned and pre-trained deep CNN architecture (GoogLeNet Inception-v3). The test dataset was used to assess the accuracy, sensitivity, specificity, receiver operating characteristic curve, area under the receiver operating characteristic curve (AUC), and confusion matrix compared between deep CNN and periodontal specialist.We found that the deep CNN architecture (AUC = 0.971, 95% confidence interval 0.963-0.978) and board-certified periodontist (AUC = 0.925, 95% confidence interval 0.913-0.935) showed reliable classification accuracies.This study demonstrated that deep CNN architecture is useful for the identification and classification of dental implant systems using panoramic and periapical radiographic images.",2020,"We found that the deep CNN architecture (AUC = 0.971, 95% confidence interval 0.963-0.978) and board-certified periodontist (AUC = 0.925, 95% confidence interval 0.913-0.935) showed reliable classification accuracies.","['A total of 5390 panoramic and 5380 periapical radiographic images from 3 types of dental implant systems, with similar shape and internal conical connection']","['Convolutional neural networks (CNNs', 'deep CNN algorithm', 'deep convolutional neural network algorithm']","['accuracy, sensitivity, specificity, receiver operating characteristic curve, area under the receiver operating characteristic curve (AUC), and confusion matrix']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3880579', 'cui_str': 'Dental implant system'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]",5390.0,0.0265642,"We found that the deep CNN architecture (AUC = 0.971, 95% confidence interval 0.963-0.978) and board-certified periodontist (AUC = 0.925, 95% confidence interval 0.913-0.935) showed reliable classification accuracies.","[{'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Seong-Nyum', 'Initials': 'SN', 'LastName': 'Jeong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020787'] 3055,32590780,Evaluation of rehabilitation effect of five-step exercises on patients with radiculopathy of cervical vertebra.,"BACKGROUND Among all types of cervical spondylitis, cervical spondylitis radiculopathy (CSR) has the highest incidence. The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life. This study proposes to improve the recovery rate of patients with CSR, delay the recurrence, improve the symptoms of patients, and improve the quality of life of patients through the rehabilitation and exercise of five-step cervical vertebra exercises. METHODS For 90 patients with CSR that met the inclusion criteria, SPSS 23.0 software random number generator was used to randomly divide the patients into an experimental group and control group, with 45 cases in each group. The control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises on the basis of elementary nursing measures. The rehabilitation effect of five-step exercises on CSR patients was evaluated by Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM) before and after intervention. RESULTS The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchproj.aspx) and in peer-reviewed journals or academic conferences. CONCLUSIONS This study will examine the feasibility and preliminary effects of five-step exercises for the treatment of patients with CSR. TRIAL REGISTRATION This protocol was registered in Clinical Trials platform with the number ChiCTR1900027299.",2020,"The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life.","['90 patients with CSR', 'patients with radiculopathy of cervical vertebra', 'patients with CSR']","['control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises', 'five-step exercises']","['recovery rate', 'Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263854', 'cui_str': 'Cervical arthritis'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C3665420', 'cui_str': 'Bone structure of cervical vertebra'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C3665420', 'cui_str': 'Bone structure of cervical vertebra'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",90.0,0.0298168,"The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Zhilong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Lingge', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Lanzhou University, Lanzhou, Gansu, China.'}]",Medicine,['10.1097/MD.0000000000020846'] 3056,32590942,Pharmacokinetic study of two different rifabutin doses co-administered with lopinavir/ritonavir in African HIV and tuberculosis co-infected adult patients.,"BACKGROUND This study aimed to assess the pharmacokinetic profile of 150 mg rifabutin (RBT) taken every other day (every 48 h) versus 300 mg RBT taken every other day (E.O.D), both in combination with lopinavir/ritonavir (LPV/r), in adult patients with human immunodeficiency virus (HIV) and tuberculosis (TB) co-infection. METHODS This is a two-arm, open-label, pharmacokinetic, randomised study conducted in Burkina Faso between May 2013 and December 2015. Enrolled patients were randomised to receive either 150 mg RBT EOD (arm A, 9 subjects) or 300 mg RBT EOD (arm B, 7 subjects), both associated with LPV/r taken twice daily. RBT plasma concentrations were evaluated after 2 weeks of combined HIV and TB treatment. Samples were collected just before drug ingestion and at 1, 2, 3, 4, 6, 8, and 12 h after drug ingestion to measure plasma drug concentration using an HPLC-MS/MS assay. RESULTS The Cmax and AUC 0-12h medians in arm A (Cmax = 296 ng/mL, IQR: 205-45; AUC 0-12h  = 2528 ng.h/mL, IQR: 1684-2735) were lower than those in arm B (Cmax = 600 ng/mL, IQR: 403-717; AUC 0-12h  = 4042.5 ng.h/mL, IQR: 3469-5761), with a statistically significant difference in AUC 0-12h (p = 0.044) but not in Cmax (p = 0.313). No significant differences were observed in Tmax (3 h versus 4 h). Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm. Additionally, at 48 h after drug ingestion, all patients had a mycobacterial minimum inhibitory concentration (MIC) above the limit (> 64 ng/mL) in the 300 mg RBT arm, while 4/9 patients had such values in the 150 mg RBT arm. CONCLUSION This study confirmed that the 150 mg dose of rifabutin ingested EOD in combination with LPV/r is inadequate and could lead to selection of rifamycin-resistant mycobacteria. TRIAL REGISTRATION PACTR201310000629390, 28th October 2013.",2020,"Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm.","['Burkina Faso between May 2013 and December 2015', 'African HIV and tuberculosis co-infected adult patients', 'adult patients with human immunodeficiency virus (HIV) and tuberculosis (TB']","['rifabutin ingested EOD', 'rifabutin doses co-administered with lopinavir/ritonavir', '300\u2009mg RBT EOD', '150\u2009mg RBT EOD', 'lopinavir/ritonavir (LPV/r', 'rifabutin (RBT']","['RBT plasma concentrations', 'Cmax below the plasma therapeutic limit', 'Tmax', 'mycobacterial minimum inhibitory concentration (MIC', 'Cmax and AUC']","[{'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0427978', 'cui_str': 'MIC'}, {'cui': 'C0066256', 'cui_str': 'Methyl isocyanate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",2735.0,0.0847334,"Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm.","[{'ForeName': 'Seni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso. skouanda@irss.bf.'}, {'ForeName': 'Henri Gautier', 'Initials': 'HG', 'LastName': 'Ouedraogo', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Kadari', 'Initials': 'K', 'LastName': 'Cisse', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Tegwinde Rebeca', 'Initials': 'TR', 'LastName': 'Compaoré', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Sulis', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Diagbouga', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Roggi', 'Affiliation': 'Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.'}, {'ForeName': 'Grissoum', 'Initials': 'G', 'LastName': 'Tarnagda', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Villani', 'Affiliation': 'Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.'}, {'ForeName': 'Lassana', 'Initials': 'L', 'LastName': 'Sangare', 'Affiliation': 'Yalgado Ouedraogo University Teaching Hospital, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Simporé', 'Affiliation': 'Centre de Recherche Biomoléculaire Pietro Annigoni (CERBA), Ouagadougou, Burkina Faso.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Regazzi', 'Affiliation': 'Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Matteelli', 'Affiliation': 'Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.'}]",BMC infectious diseases,['10.1186/s12879-020-05169-2'] 3057,32590944,"Efficacy and safety of intracoronary prourokinase during percutaneous coronary intervention in treating ST-segment elevation myocardial infarction patients: a randomized, controlled study.","BACKGROUND Prourokinase is a single-chain plasminogen activator presenting with fewer hemorrhagic complications and reduced reocclusion rate compared with the conventional fibrinolytic agents in patients with coronary artery disease. However, prourokinase intracoronary injection during PCI for treating patients with ST-segment elevation myocardial infarction (STEMI) is rarely investigated. Therefore, this study aimed to evaluate the efficacy and safety of intracoronary prourokinase during the percutaneous coronary intervention (PCI) in treating STEMI patients. METHODS Fifty STEMI patients who underwent primary PCI were consecutively enrolled and randomly assigned to intracoronary prourokinase group (N = 25) or control group (N = 25). During the primary PCI procedure, patients in the intracoronary prourokinase group received 10 ml prourokinase injection, while patients in control group received 10 ml saline injection as control. The primary endpoints were coronary physiological indexes, the secondary endpoints were angiographic assessments, myocardial infarct size/reperfusion assessment, cardiac function evaluations, major adverse coronary events (MACEs) and hemorrhagic complications. All patients were followed up for 3 months. RESULTS Post PCI, the index of microcirculatory resistance (IMR) was decreased in intracoronary prourokinase group than that in control group (34.56 ± 7.48 vs. 49.00 ± 8.98, P < 0.001), while no difference of coronary flow reserve (CFR) (2.01 ± 0.32 vs. 1.88 ± 0.23, P = 0.267) or fractional flow reserve (FFR) (0.89 ± 0.05 vs. 0.87 ± 0.04, P = 0.121) was found between the two groups. The thrombolysis in myocardial infarction myocardial perfusion grade (TMPG) (P = 0.024), peak values of creatine kinase (CK) (P = 0.028), CK isoenzyme-MB (CK-MB) (P = 0.016), cardiac troponin I (cTnI) (P = 0.032) and complete ST-segment resolution (STR) (P = 0.005) were better in intracoronary prourokinase group compared with control group. At 3-months post PCI, left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) were higher, while left ventricular end-diastolic diameter (LVEDd) was lower in intracoronary prourokinase group compared with control group (all P < 0.05). There was no difference in hemorrhagic complication or total MACE between the two groups. CONCLUSION Intracoronary prourokinase during PCI is more efficient and equally tolerant compared with PCI alone in treating STEMI patients. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1800016207 . Prospectively registered.",2020,"The thrombolysis in myocardial infarction myocardial perfusion grade (TMPG) (P = 0.024), peak values of creatine kinase (CK) (P = 0.028), CK isoenzyme-MB (CK-MB) (P = 0.016), cardiac troponin","['treating ST-segment elevation myocardial infarction patients', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with coronary artery disease', 'Fifty STEMI patients who underwent primary PCI']","['percutaneous coronary intervention (PCI', 'conventional fibrinolytic agents', 'percutaneous coronary intervention', 'intracoronary prourokinase', '10\u2009ml saline injection', '10\u2009ml prourokinase injection']","['angiographic assessments, myocardial infarct size/reperfusion assessment, cardiac function evaluations, major adverse coronary events (MACEs) and hemorrhagic complications', 'coronary flow reserve (CFR', 'hemorrhagic complication or total MACE', 'left ventricular end-diastolic diameter (LVEDd', 'CK isoenzyme-MB (CK-MB', 'Efficacy and safety', 'I (cTnI', 'myocardial infarction myocardial perfusion grade (TMPG', 'fractional flow reserve (FFR', 'efficacy and safety', 'peak values of creatine kinase (CK', 'cardiac troponin', 'complete ST-segment resolution (STR', 'index of microcirculatory resistance (IMR', 'reocclusion rate', 'left ventricular ejection fraction (LVEF) and wall motion score index (WMSI', 'coronary physiological indexes']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016018', 'cui_str': 'Thrombolytic agent'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0010288', 'cui_str': 'Creatine kinase isoenzyme'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0854571', 'cui_str': 'Reocclusion'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",50.0,0.0777143,"The thrombolysis in myocardial infarction myocardial perfusion grade (TMPG) (P = 0.024), peak values of creatine kinase (CK) (P = 0.028), CK isoenzyme-MB (CK-MB) (P = 0.016), cardiac troponin","[{'ForeName': 'Yanqiang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China. dufang27481519@163.com.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, Handan Central Hospital, Handan, 056000, China.'}, {'ForeName': 'Xinshun', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Guozhen', 'Initials': 'G', 'LastName': 'Hao', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Weize', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Yunfa', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01584-0'] 3058,32590958,"Rationale and design of ""Hearts & Parks"": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.","BACKGROUND The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems. METHODS Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification. DISCUSSION We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research-defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response. CLINICAL TRIAL REGISTRATION NCT03339440 .",2020,"We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months.",[],"['intensive behavioral interventions', 'clinic-community child obesity treatment intervention', 'integrated clinic-community child obesity intervention', 'integrated clinic-community intervention']","['body mass index (BMI) and reverse disease risk', 'changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life', 'body mass index (BMI']",[],"[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0729411,"We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months.","[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Armstrong', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'McAllister', 'Initials': 'M', 'LastName': 'Windom', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Bihlmeyer', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Svati H', 'Initials': 'SH', 'LastName': 'Shah', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Story', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Zucker', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Wiedemeier', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Sibley', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Samuel I', 'Initials': 'SI', 'LastName': 'Berchuck', 'Affiliation': 'Department of Statistical Science, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zizzi', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sarria', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Dressman', 'Affiliation': 'Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Rawls', 'Affiliation': 'Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.'}, {'ForeName': 'Asheley C', 'Initials': 'AC', 'LastName': 'Skinner', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA. asheley.skinner@duke.edu.'}]",BMC pediatrics,['10.1186/s12887-020-02190-x'] 3059,32590959,"Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet: a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation.","BACKGROUND Chronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions. Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of, an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain. METHODS This is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation comparing the Internet-based pain education and exercise intervention with a control group that will receive an online booklet. One hundred and sixty patients will be recruited from Sao Paulo, Brazil. Follow-ups will be conducted in post-treatment, 6 and 12 months after randomisation. The conduct of the study, as well as the evaluations and follow-ups will be carried out entirely remotely, through online platforms and telephone calls. The primary outcome will be pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale. Secondary outcomes will be biopsychosocial factors presents in the chronic musculoskeletal pain condition. Costs due to chronic musculoskeletal pain will be also measured, and cost-effectiveness analysis from a societal perspective will performed. DISCUSSION Our hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain. In addition, we believe that there will be good acceptance of patients for the internet-based intervention and that internet-based intervention will be more cost effective than the online booklet. TRIAL REGISTRATION The study was prospectively registered at ClinicalTrials.gov ( NCT04274439 , registered 18 February 2020).",2020,"Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment.","['people with chronic musculoskeletal pain', 'patients with chronic musculoskeletal pain', 'One hundred and sixty patients will be recruited from Sao Paulo, Brazil']","['online self-management booklet', 'internet-based pain education and exercise program', 'internet-based self-management program based on pain education and exercise', 'Internet-based pain education and exercise intervention']","['pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale', 'chronic musculoskeletal pain condition', 'chronic musculoskeletal pain', 'pain and improving biopsychosocial outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",160.0,0.196983,"Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment.","[{'ForeName': 'Iuri', 'Initials': 'I', 'LastName': 'Fioratti', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Saragiotto', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil. bruno.saragiotto@unicid.edu.br.'}, {'ForeName': 'Felipe J J', 'Initials': 'FJJ', 'LastName': 'Reis', 'Affiliation': 'Department of Physical Therapy, Instituto Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gisela C', 'Initials': 'GC', 'LastName': 'Miyamoto', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Centre for Statistics in Medicine, Rehabilitation Research in Oxford, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.'}, {'ForeName': 'Tiê P', 'Initials': 'TP', 'LastName': 'Yamato', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Junior V', 'Initials': 'JV', 'LastName': 'Fandim', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Dear', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Leonardo O P', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03423-x'] 3060,32591267,The Effect of Motivational Interviewing on Women with Overweight and Obesity Before Conception.,"OBJECTIVE To investigate the efficacy of motivational interviewing (MI) to elicit change in eating and physical activity behaviors in women with overweight and obesity before conception. DESIGN A randomized controlled trial was conducted. The participants were randomly divided into intervention and comparison groups. Data were gathered using the Three-Factor Eating Questionnaire Revised 18-item version (TFEQ-R18), International Physical Activity Questionnaire (IPAQ), and Stages of Change checklist. SETTING Primary health centers of Tabriz, Iran. PARTICIPANTS The participants were 70 women with overweight or obesity, aged 18-35 years, who were referred for preconception care. INTERVENTION(S) The intervention group received 6 MI sessions, and the comparison group received routine preconception care. MAIN OUTCOME MEASURE(S) Variables of primary outcomes were eating behavior measures and physical activity levels 8 weeks after intervention. ANALYSIS Independent t test, ANCOVA, Fisher exact test, Mann-Whitney U test, and Wilcoxon test were used. RESULTS The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively). After the intervention, the mean score of cognitive restraint in the intervention group was higher than in the comparison group (adjusted mean difference, 16.9; 95% CI, 10.8 to 23.0; P < .001), whereas there were no significant differences between the 2 groups in terms of emotional and uncontrolled eating (P = .33 and P = .25, respectively). CONCLUSIONS AND IMPLICATIONS The MI had a positive effect on physical activity and eating behavior change, except for uncontrolled and emotional eating. Future studies to examine differences between overweight and women with obesity and within other populations is warranted.",2020,"The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively).","['women with overweight and obesity before conception', 'Primary health centers of Tabriz, Iran', 'participants were 70 women with overweight or obesity, aged 18-35 years, who were referred for preconception care', 'Women with Overweight and Obesity Before Conception']","['6 MI sessions, and the comparison group received routine preconception care', 'motivational interviewing (MI', 'Motivational Interviewing']","['mean score of cognitive restraint', 'Factor Eating Questionnaire Revised 18-item version (TFEQ-R18), International Physical Activity Questionnaire (IPAQ), and Stages of Change checklist', 'emotional and uncontrolled eating', 'physical activity', 'eating and physical activity behaviors', 'eating behavior measures and physical activity levels', 'physical activity and eating behavior change']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085284', 'cui_str': 'Preconception care'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0085284', 'cui_str': 'Preconception care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",70.0,0.0661103,"The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively).","[{'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Nourizadeh', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Azami', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Azizeh', 'Initials': 'A', 'LastName': 'Farshbaf-Khalili', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: b.mehrabi62@gmail.com.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.04.219'] 3061,32591274,Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial.,"INTRODUCTION The objective of this study was to evaluate the distalization rate and changes in inclination of the maxillary canines in alveoli preserved with leukocyte-platelet-rich fibrin (L-PRF) membranes in adult patients. The null hypothesis was that there are no differences in the canine distalization movement rate between the treated and the control sides. METHODS A total of 21 healthy adult patients with a minimum age of 20 years (mean age, 33 ± 5.9 years) and Angle Class I or Class II Division 1 malocclusion, who had an indication of extraction of the maxillary first premolars and orthodontic distalization of the maxillary canines were included in this study. A randomized controlled clinical split-mouth trial was conducted; the experimental maxillary side was treated with L-PRF membranes, and the other side served as the control. A randomization sequence of the experimental sides among patients was generated using the random number generation function of Microsoft Excel. Neither the patients nor the operators were blinded. Fifteen days after the extractions, distalization was initiated using an elastic chain applying 150 g of force to the canines on a 0.020-in stainless steel archwire. The distalization rate was the main outcome of the study, and it was assessed monthly for 5 months through the intraoral use of a flexible ruler. The degree of inclination of the canines was the secondary outcome, and it was evaluated through cone-beam computed tomography. A Shapiro-Wilk test was performed, and a Wilcoxon signed rank test was subsequently used to compare the experimental and the control group. Spearman rank correlation coefficient was calculated to evaluate the correlation between distalization and inclination for each side. RESULTS Four of the subjects dropped out of the study, leaving a total of 17 patients (n = 17). The distalization rate and inclination of the canines were greater on the control side than on the side treated with L-PRF (P <0.05). A weak correlation was found between the distalization rate and inclination of the canines for both sides (control side, ρ = 0.17; experimental, ρ = 0.11). No harm was observed during the study. CONCLUSIONS The null hypothesis was rejected. The use of L-PRF in young adult patients decreased the rate of distalization and changes in inclination of the maxillary canines compared with the control group. REGISTRATION This trial was not registered. PROTOCOL The protocol was not published before trial commencement.",2020,The distalization rate and inclination of the canines were greater on the control side than on the side treated with L-PRF (P <0.05).,"['adult patients', 'adults', 'young adult patients', '21 healthy adult patients with a minimum age of 20\xa0years (mean age, 33\xa0±\xa05.9\xa0years) and Angle Class I or Class II Division 1 malocclusion, who had an indication of extraction of the maxillary first premolars and orthodontic distalization of the maxillary canines were included in this study']","['leukocyte-platelet-rich fibrin', 'L-PRF membranes', 'L-PRF', 'leukocyte-platelet-rich fibrin (L-PRF) membranes']","['canine distalization movement rate', 'rate of distalization and changes in inclination of the maxillary canines', 'Distalization rate of maxillary canines', 'distalization rate', 'distalization rate and inclination of the canines']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0399523', 'cui_str': 'Malocclusion, Angle class I'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]",21.0,0.0473179,The distalization rate and inclination of the canines were greater on the control side than on the side treated with L-PRF (P <0.05).,"[{'ForeName': 'Ariel Adriano', 'Initials': 'AA', 'LastName': 'Reyes Pacheco', 'Affiliation': 'Department of Periodontology and Oral Implantology, Pontifícia Universidad Católica Madre y Maestra, Santo Domingo, Dominican Republic.'}, {'ForeName': 'James Rudolph', 'Initials': 'JR', 'LastName': 'Collins', 'Affiliation': 'Department of Periodontology and Oral Implantology, Pontifícia Universidad Católica Madre y Maestra, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Nelsida', 'Initials': 'N', 'LastName': 'Contreras', 'Affiliation': 'Department of Periodontology and Oral Implantology, Pontifícia Universidad Católica Madre y Maestra, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Lantigua', 'Affiliation': 'Department of Periodontology and Oral Implantology, Pontifícia Universidad Católica Madre y Maestra, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Matheus Melo', 'Initials': 'MM', 'LastName': 'Pithon', 'Affiliation': 'Department of Orthodontics, Southwest Bahia State University, Jequié, Bahia, Brazil.'}, {'ForeName': 'Orlando Motohiro', 'Initials': 'OM', 'LastName': 'Tanaka', 'Affiliation': 'School of Life Sciences, Pontifícia Universidade Católica do Paraná, Curitiba, Paraná, Brazil. Electronic address: tanaka.o@pucpr.br.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.03.020'] 3062,32591295,Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial.,"INTRODUCTION AND OBJECTIVES Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists. METHODS ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months. RESULTS The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01. CONCLUSIONS ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.",2020,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","['320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to', 'HF patients with reduced left ventricular ejection fraction']","['angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB', 'HF nurse titration vs 156 to HF cardiologist titration']","['mortality and heart failure (HF) hospitalizations', 'safety and efficacy', 'adverse events', 'ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months', 'mean±standard deviation visits', 'beta-blocker mean relative dose']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",320.0,0.116585,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","[{'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Oyanguren', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain; BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain. Electronic address: juanaoy@hotmail.com.'}, {'ForeName': 'Lluisa', 'Initials': 'L', 'LastName': 'Garcia-Garrido', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Nebot-Margalef', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Latorre-García', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Torcal-Laguna', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Roure', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Costello', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Manito', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'García-Pinilla', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sánchez-Paule', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Varela-Román', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Moure', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Segovia-Cubero', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Soria', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Eunate', 'Initials': 'E', 'LastName': 'Arana-Arri', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Lekuona', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.04.016'] 3063,32591310,Machine-learning-based in-hospital mortality prediction for transcatheter mitral valve repair in the United States.,"BACKGROUND Transcatheter mitral valve repair 2 utilization has increased significantly in the United States over the last years. Yet, a risk-prediction tool for adverse events has not been developed. We aimed to generate a machine-learning-based algorithm to predict in-hospital mortality after TMVR. METHODS Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database. The study population was randomly divided into a training set (n = 636) and a testing set (n = 213). Prediction models for in-hospital mortality were obtained using five supervised machine-learning classifiers. RESULTS A total of 849 TMVRs were analyzed in our study. The overall in-hospital mortality was 3.1%. A naïve Bayes (NB) model had the best discrimination for fifteen variables, with an area under the receiver-operating curve (AUC) of 0.83 (95% CI, 0.80-0.87), compared to 0.77 for logistic regression (95% CI, 0.58-0.95), 0.73 for an artificial neural network (95% CI, 0.55-0.91), and 0.67 for both a random forest and a support-vector machine (95% CI, 0.47-0.87). History of coronary artery disease, of chronic kidney disease, and smoking were the three most significant predictors of in-hospital mortality. CONCLUSIONS We developed a robust machine-learning-derived model to predict in-hospital mortality in patients undergoing TMVR. This model is promising for decision-making and deserves further clinical validation.",2020,The overall in-hospital mortality was 3.1%.,"['A total of 849 TMVRs', 'Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database', 'patients undergoing TMVR']","['machine-learning-based algorithm', 'Transcatheter mitral valve', 'repair']",['hospital mortality'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",849.0,0.053033,The overall in-hospital mortality was 3.1%.,"[{'ForeName': 'Dagmar F', 'Initials': 'DF', 'LastName': 'Hernandez-Suarez', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Puerto Rico School of Medicine, San Juan, PR, USA. Electronic address: dagmar.hernandez@upr.edu.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Ranka', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Yeunjung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Wiley', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Lopez-Candales', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Duane S', 'Initials': 'DS', 'LastName': 'Pinto', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maday C', 'Initials': 'MC', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ramakrishna', 'Affiliation': 'Division of Cardiovascular and Thoracic Anesthesiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sanina', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Brenda G', 'Initials': 'BG', 'LastName': 'Nieves-Rodriguez', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Jovaniel', 'Initials': 'J', 'LastName': 'Rodriguez-Maldonado', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Feliu Maldonado', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Israel J', 'Initials': 'IJ', 'LastName': 'Rodriguez-Ruiz', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Istoni', 'Initials': 'I', 'LastName': ""da Luz Sant'Ana"", 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Karlo A', 'Initials': 'KA', 'LastName': 'Wiley', 'Affiliation': 'College of Agriculture and Life Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cox-Alomar', 'Affiliation': 'Division of Cardiology, Department of Medicine, Louisiana State University, New Orleans, LA, USA.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Villablanca', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Abiel', 'Initials': 'A', 'LastName': 'Roche-Lima', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.06.017'] 3064,32590831,Long-Axis In-Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization in Pediatric Patients: A Randomized Controlled Trial.,"OBJECTIVES The aim of this study was to compare the occurrence of posterior wall puncture between the long-axis in-plane and the short-axis out-of-plane approaches in a randomized controlled trial of pediatric patients who underwent cardiovascular surgery under general anesthesia. DESIGN Prospective randomized controlled trial. SETTING Operating room of Osaka Women's and Children's Hospital. PATIENTS Pediatric patients less than 5 years old who underwent cardiovascular surgery. INTERVENTIONS Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach. MEASUREMENTS AND MAIN RESULTS The occurrence of posterior wall puncture was compared between the long-axis in-plane and short-axis out-of-plane approaches for ultrasound-guided central venous catheterization. Patients were randomly allocated to a long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group). After exclusion, 97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups. Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003). First attempt success rates were 67.3% (33/49) and 64.6% (31/48) in the long-axis and short-axis groups, respectively (relative risk, 1.04; 95% CI, 0.78-1.39; p = 0.77). Overall success rates within 20 minutes were 93.9% (46/49) and 93.8% (45/48) in the long-axis and short-axis groups, respectively (relative risk, 0.99; 95% CI, 0.90-1.11; p = 0.98). CONCLUSIONS The long-axis in-plane approach for ultrasound-guided central venous catheterization is a useful technique for avoiding posterior wall puncture in pediatric patients, compared with the short-axis out-of-plane approach.",2020,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","['97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups', ""Operating room of Osaka Women's and Children's Hospital"", 'pediatric patients', 'Pediatric Patients', 'pediatric patients who underwent cardiovascular surgery under general anesthesia', 'Pediatric patients less than 5 years old who underwent cardiovascular surgery']","['long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group', 'Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization', 'Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach', 'ultrasound-guided central venous catheterization']","['occurrence of posterior wall puncture', 'success rates', 'Overall success rates', 'Posterior wall puncture rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",97.0,0.0729776,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Nakajima', 'Affiliation': 'Department of Anesthesiology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nagai', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Fujiwara', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Hamaba', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsuura', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Institute of Biomedical & Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002476'] 3065,32590885,Effect of thickness and occlusal accommodation on the degree of satisfaction with mouthguard use among water polo players: A randomized crossover trial.,"BACKGROUND/AIM The optimal mouthguard type and design for each player and sport is currently unknown. The aim of this study was to assess the effect of using a thicker custom-made mouthguard with occlusal accommodation on the degree of satisfaction among water polo players. MATERIAL AND METHODS Twenty-five elite water polo players participated in this randomized four-period crossover trial conducted from February to May 2019. For each participant two customized mouthguards were fabricated using 4-mm ethyl vinyl acetate foil: Type A included no occlusal accommodation and Type B included a 2-mm occlusal accommodation. Players wore each mouthguard during training sessions and competitions for two weeks in one of two randomized sequences. After each match or training session, players were asked to evaluate the mouthguards on 10-point scales across three domains: discomfort or interference with function, protection, and general satisfaction. Mouthguard preference was also recorded. RESULTS The mouthguard with occlusal accommodation was reported to interfere more with speech and swallowing (P < 0.001) and with aesthetics, breathing, and athletic performance (P < 0.05) compared with the conventional mouthguard. Although occlusal accommodation was associated with a higher perceived degree of protection (mean difference 0.5; 95% CI 0.2-0.8), players were still more satisfied with the conventional mouthguard (mean difference 1.5; 95% CI 0.8-2.3). Two players preferred the occlusal mouthguard, whereas 22 preferred the conventional mouthguard (P = 0.007). CONCLUSIONS Among water polo players, occlusal accommodation increasing the thickness of the custom-made mouthguards may offer a greater perceived sense of protection, but this comes at the cost of greater discomfort and reduced overall satisfaction. Dentists can recommend conventional mouthguards for most water polo players.",2020,"The mouthguard with occlusal accommodation was reported to interfere more with speech and swallowing (P < 0.001) and with aesthetics, breathing, and athletic performance (P < 0.05) compared with the conventional mouthguard.","['Twenty-five elite water polo players participated in this randomized four-period crossover trial conducted from February to May 2019', 'water polo players']","['thicker custom-made mouthguard with occlusal accommodation', 'thickness and occlusal accommodation']","['discomfort or interference with function, protection, and general satisfaction', 'speech and swallowing', 'aesthetics, breathing, and athletic performance']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C2712390', 'cui_str': 'Water Polo'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C3880278', 'cui_str': 'Mouthguard, custom-made'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]",,0.098461,"The mouthguard with occlusal accommodation was reported to interfere more with speech and swallowing (P < 0.001) and with aesthetics, breathing, and athletic performance (P < 0.05) compared with the conventional mouthguard.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Flores-Figueiras', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Zamora-Olave', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Willaert', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Martinez-Gomis', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Catalonia, Spain.'}]",Dental traumatology : official publication of International Association for Dental Traumatology,['10.1111/edt.12583'] 3066,32590979,"Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based trainings among health workers on day of birth care in Nigeria; a cluster randomized controlled trial.","BACKGROUND The aim of this study was to compare health workers knowledge and skills competencies between those trained using the onsite simulation-based, low-dose, high frequency training plus mobile mentoring (LDHF/m-mentoring) and the ones trained through traditional offsite, group-based training (TRAD) approach in Kogi and Ebonyi states, Nigeria, over a 12-month period. METHODS A prospective cluster randomized controlled trial was conducted by enrolling 299 health workers who provided healthcare to mothers and their babies on the day of birth in 60 health facilities in Kogi and Ebonyi states. These were randomized to either LDHF/m-mentoring (intervention, n = 30 facilities) or traditional group-based training (control, n = 30 facilities) control arm. They received Basic Emergency Obstetrics and Newborn Care (BEmONC) training with simulated practice using anatomic models and role-plays. The control arm was trained offsite while the intervention arm was trained onsite where they worked. Mentorship was done through telephone calls and reminder text messages. The multiple choice questions (MCQs) and objective structured clinical examinations (OSCEs) mean scores were compared; p-value < 0.05 was considered statistically significant. Qualitative data were also collected and content analysis was conducted. RESULTS The mean knowledge scores between the two arms at months 3 and 12 post-training were equally high; no statistically significant differences. Both arms showed improvements in composite scores for assessed BEmONC clinical skills from around 30% at baseline to 75% and above at end line (p < 0.05). Overall, the observed improvement and retention of skills was higher in intervention arm compared to the control arm at 12 months post-training, (p < 0.05). Some LDHF/m-mentoring approach trainees reported that mentors' support improved their acquisition and maintenance of knowledge and skills, which may have led to reductions in maternal and newborn deaths in their facilities. CONCLUSION The LDHF/m-mentoring intervention is more effective than TRAD approach in improving health workers' skills acquisition and retention. Health care managers should have the option to select the LDHF/m-mentoring learning approach, depending on their country's priorities or context, as it ensures health workers remain in their place of work during training events thus less disruption to service delivery. TRIAL REGISTRATION The trial was retrospectively registered on August 24, 2017 at ClinicalTrials.Gov: NCT03269240.",2020,The LDHF/m-mentoring intervention is more effective than TRAD approach in improving health workers' skills acquisition and retention.,"['health workers on day of birth care in Nigeria', 'enrolling 299 health workers who provided healthcare to mothers and their babies on the day of birth in 60 health facilities in Kogi and Ebonyi states']","['frequency training plus mobile mentoring (LDHF/m-mentoring) and the ones trained through traditional offsite, group-based training (TRAD) approach in Kogi and Ebonyi states, Nigeria, over a 12-month period', 'Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based trainings', 'Basic Emergency Obstetrics and Newborn Care (BEmONC) training with simulated practice using anatomic models and role-plays', 'LDHF/m-mentoring (intervention, n\u2009=\u200930 facilities) or traditional group-based training (control, n\u2009=\u200930 facilities) control arm']","['multiple choice questions (MCQs) and objective structured clinical examinations (OSCEs) mean scores', 'retention of skills', 'mean knowledge scores', 'composite scores']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C0026337', 'cui_str': 'Anatomic Models'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",299.0,0.125709,The LDHF/m-mentoring intervention is more effective than TRAD approach in improving health workers' skills acquisition and retention.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Ugwa', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria. drajulugreatgod@hotmail.co.za.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kabue', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego-, 1615 Thames St, Baltimore, MD, 21231, USA.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Otolorin', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'The Johns Hopkins Biostatistics Center, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Adetiloye', 'Initials': 'A', 'LastName': 'Oniyire', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Bright', 'Initials': 'B', 'LastName': 'Orji', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Okoli', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Enne', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Alobo', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Olisaekee', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Adebayo', 'Initials': 'A', 'LastName': 'Oluwatobi', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Oduenyi', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Adekunle', 'Initials': 'A', 'LastName': 'Aledare', 'Affiliation': 'Department of Public Health, State Ministry of Health, Lokoja, Kogi State, Nigeria.'}, {'ForeName': 'Boniface', 'Initials': 'B', 'LastName': 'Onwe', 'Affiliation': 'Department of Public Health, State Ministry of Health, Abakiliki, Ebonyi State, Nigeria.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ishola', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}]",BMC health services research,['10.1186/s12913-020-05450-9'] 3067,32591004,Study design of the DAS-OLT trial: a randomized controlled trial to evaluate the impact of dexmedetomidine on early allograft dysfunction following liver transplantation.,"BACKGROUND Perioperative ischemia/reperfusion (I/R) injury during liver transplantation is strongly associated with early allograft dysfunction (EAD), graft loss, and mortality. Hepatic I/R injury also causes remote damage to other organs including the renal and pulmonary systems. Dexmedetomidine (DEX), a selective α2-adrenoceptor agonist which is used as an adjuvant to general anesthesia, has been shown in preclinical studies to provide organ protection by ameliorating the effects of I/R injury in a range of tissues (including the liver). However, prospective clinical evidence of any potential benefits in improving outcomes in liver transplantation is lacking. This study aimed to verify the hypothesis that the application of dexmedetomidine during the perioperative period of liver transplantation can reduce the incidence of EAD and primary graft non-function (PNF). At the same time, the effects of dexmedetomidine application on perioperative renal function and lung function were studied. METHODS This is a prospective, single-center, randomized, parallel-group study. Two hundred participants (18-65 years) scheduled to undergo liver transplantation under general anesthesia will be included in this study. For participants in the treatment group, a loading dose of DEX will be given after induction of anesthesia (1 μg/kg over 10 min) followed by a continuous infusion (0.5 μg/kg /h) until the end of surgery. For participants in the placebo group, an equal volume loading dose of 0.9% saline will be given after the induction of anesthesia followed by an equal volume continuous infusion until the end of surgery. All other supplements, e.g., opioids, sedatives, and muscle relaxant, will be identical in both arms and administered according to routine clinical practice. DISCUSSION The present trial will examine whether DEX confers organoprotective effects in the liver, in terms of reducing the incidence of EAD and PNF in orthotopic liver transplantation recipients. TRIAL REGISTRATION ClinicalTrials.gov NCT03770130. Registered on 10 December 2018. https://clinicaltrials.gov/ct2/show/NCT03770130.",2020,"The present trial will examine whether DEX confers organoprotective effects in the liver, in terms of reducing the incidence of EAD and PNF in orthotopic liver transplantation recipients. ","['Two hundred participants (18-65\u2009years) scheduled to undergo liver transplantation under general anesthesia will be included in this study', 'liver transplantation', 'orthotopic liver transplantation recipients']","['placebo', 'dexmedetomidine', 'Dexmedetomidine (DEX', 'DEX']","['incidence of EAD and primary graft non-function (PNF', 'perioperative renal function and lung function', 'early allograft dysfunction (EAD), graft loss, and mortality', 'early allograft dysfunction']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0400447', 'cui_str': 'Orthotopic liver transplant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",200.0,0.207344,"The present trial will examine whether DEX confers organoprotective effects in the liver, in terms of reducing the incidence of EAD and PNF in orthotopic liver transplantation recipients. ","[{'ForeName': 'Chenlu', 'Initials': 'C', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Masters', 'Affiliation': 'Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UK.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Yingfu', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Suqing', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China. lqyang72721@126.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China. renji_qibo@foxmail.com.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UK.'}]",Trials,['10.1186/s13063-020-04497-7'] 3068,32591007,INdividual Vocational and Educational Support Trial (INVEST) for young people with borderline personality disorder: study protocol for a randomised controlled trial.,"BACKGROUND The clinical onset of borderline personality disorder (BPD) usually occurs in young people (aged 12-25 years) and commonly leads to difficulty achieving and maintaining vocational (education and/or employment) engagement. While current psychosocial interventions lead to improvements in psychopathology, they have little effect upon functioning. Individual Placement and Support (IPS) is a client-driven model that assists individuals with severe mental illness to engage with education and/or employment appropriate to their personal goals, and that provides ongoing support to maintain this engagement. The objective of the INdividual Vocational and Educational Support Trial (INVEST) is to evaluate the effectiveness of adding IPS to an evidence-based early intervention programme for BPD, with the aim of improving vocational outcomes. METHODS/DESIGN INVEST is a single-blind, parallel-groups, randomised controlled trial (RCT). The randomisation is stratified by gender and age and uses random permuted blocks. The interventions are 39 weeks of either IPS, or 'usual vocational services' (UVS). Participants will comprise 108 help-seeking young people (aged 15-25 years) with three or more DSM-5 BPD features and a desire to study or work, recruited from the Helping Young People Early (HYPE) early intervention programme for BPD at Orygen, in Melbourne, Australia. All participants will receive the HYPE intervention. After baseline assessment, staff who are blind to the intervention group allocation will conduct assessments at 13, 26, 39 and 52 weeks. At the 52-week primary endpoint, the primary outcome is the number of days in mainstream education/employment since baseline. Secondary outcomes include the cost-effectiveness of the intervention, quality of life, and BPD severity. DISCUSSION Current treatments for BPD have little impact on vocational outcomes and enduring functional impairment is prevalent among this patient group. IPS is a targeted functional intervention, which has proven effective in improving vocational outcomes for adults and young people with psychotic disorders. This trial will investigate whether IPS is effective for improving vocational (employment and educational) outcomes among young people with subthreshold or full-syndrome BPD. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry, ID: ACTRN12619001220156 . 13 September 2019.",2020,"IPS is a targeted functional intervention, which has proven effective in improving vocational outcomes for adults and young people with psychotic disorders.","['adults and young people with psychotic disorders', 'Participants will comprise 108 help-seeking young people (aged 15-25\u2009years) with three or more DSM-5 BPD features and a desire to study or work, recruited from the Helping Young People Early (HYPE) early intervention programme for BPD at Orygen, in Melbourne, Australia', 'young people (aged 12-25\u2009years', 'young people with borderline personality disorder', 'young people with subthreshold or full-syndrome BPD', 'individuals with severe mental illness']","['INdividual Vocational and Educational Support Trial (INVEST', 'Individual Placement and Support (IPS', 'HYPE intervention', 'IPS', ""IPS, or 'usual vocational services' (UVS""]","['cost-effectiveness of the intervention, quality of life, and BPD severity', 'number of days in mainstream education/employment since baseline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.130796,"IPS is a targeted functional intervention, which has proven effective in improving vocational outcomes for adults and young people with psychotic disorders.","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Chanen', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia. andrew.chanen@orygen.org.au.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nicol', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Betts', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'IPS Employment Center, Rockville Institute and Westat Inc., 85 Mechanic Street, Suite C3-1, Box 4A, Lebanon, NH, 03766, USA.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, VIC, 3220, Australia.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Jackson', 'Affiliation': 'Melbourne School of Psychological Sciences, Redmond Barry Building, The University of Melbourne, Parkville, Melbourne, VIC, 3010, Australia.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Thompson', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Jovev', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Chinnery', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Ring', 'Affiliation': 'Travancore School, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCutcheon', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Ashleigh P', 'Initials': 'AP', 'LastName': 'Salmon', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Killackey', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}]",Trials,['10.1186/s13063-020-04471-3'] 3069,32591170,"Targeting Cognitive Control Deficits With Neuroplasticity-Based Computerized Cognitive Remediation in Patients With Geriatric Major Depression: A Randomized, Double-Blind, Controlled Trial.","Late life major depression (LLD) is often accompanied by cognitive deficits. When patients have specific deficits in cognitive control functions (CCD), they are not only distressing and debilitating, they often predict poor clinical outcomes such as reduced response to SSRI/SNRI antidepressants, increased disability, suicide and all-cause mortality. We recently reported that in an open label trial, our treatment designed to target these specific CCD with neuroplasticity-based computerized cognitive remediation (nCCR) improved depression and CCD in patients who failed to remit with conventional antidepressant treatment. This study tested the hypothesis that in patients with LLD who have failed at least one trial of an SSRI/SNRI antidepressant at an adequate dose for at least 8 weeks, nCCR will improve both depressive symptoms and the CCD associated with poor antidepressant response (i.e. semantic strategy, inhibition of prepotent responses) more than an active control group. Participants were randomized (1:1) to receive either 30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff. All participants and raters were blinded. Mixed effects model analysis the time effect (week) (F(1,71.22)=25.2, p<0.0001) and treatment group X time interaction (F(1,61.8)=11.37, p=.002) reached significance indicating that the slope of decline in MADRS was steeper in the nCCR-GD group. Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B). Further, results transferred to memory performance, which was not a function trained by nCCR. clinicaltrials.gov.",2020,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","['With Geriatric Major Depression', 'patients who failed to remit with conventional antidepressant treatment', 'patients with LLD who have failed at least one trial of an', 'Patients']","['neuroplasticity-based computerized cognitive remediation (nCCR', '30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff', 'Neuroplasticity-Based Computerized Cognitive Remediation', 'SSRI/SNRI antidepressant']","['Stroop interference condition, and cognitive flexibility (Trails B', 'MADRS', 'Late life major depression (LLD']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008928', 'cui_str': 'Cleidocranial dysostosis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}]","[{'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.145174,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","[{'ForeName': 'Sarah Shizuko', 'Initials': 'SS', 'LastName': 'Morimoto', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT. Electronic address: sarah.morimoto@hsc.utah.edu.'}, {'ForeName': 'Roger Alan', 'Initials': 'RA', 'LastName': 'Altizer', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Therapeutic Games and Apps Lab, Department of Entertainment Arts and Engineering, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Zhongda Hospital, Medical School of Southeast University, Nanjing, China.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cote', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Nitis', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.023'] 3070,32591326,"Improving pharmacist-patient communications based on King's theory of goal attainment: Study protocol for a cluster randomized controlled trial in Hubei, China.","INTRODUCTION Previous studies revealed widespread poor communications between pharmacists and patients in various settings. But little is known about how pharmacists communicate with patients and its impact on patient outcomes. King's theory of goal attainment (TGA) describes the dynamic interpersonal interactions in which a patient develops and attains certain goals. This study aims to: (i) test the TGA model in the interface between pharmacists and patients; and (ii) evaluate the effects of TGA-guided interventions. METHODS The study will be conducted in 30 community pharmacies recruited from three cities in China's Hubei province. It will start with a baseline cross-sectional survey on 640 patients to test the hypothesized TGA model in community pharmacies. An intervention program will then be developed based on the TGA model and will be evaluated in a matched-pair cluster randomized trial. The participating pharmacies will be pair-matched and randomly allocated to an intervention group and a control group. Pharmacists in the intervention group will receive three sessions of training in line with the TGA model over one year, compared with a pharmaceutical training program in the control group without a communication component. A double-blind procedure will apply. Changes in patient experience in communications and pharmaceutical care will be analyzed. Ethics and dissemination: The study was approved by the Research Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (IORG: IORG 0003571). TRIAL REGISTRATION ChiCTR1800014679.",2020,"Pharmacists in the intervention group will receive three sessions of training in line with the TGA model over one year, compared with a pharmaceutical training program in the control group without a communication component.","['Tongji Medical College, Huazhong University of Science and Technology', '640 patients to test the hypothesized TGA model in community pharmacies', ""30 community pharmacies recruited from three cities in China's Hubei province""]","['pharmaceutical training program in the control group without a communication component', 'TGA-guided interventions']",[],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0766986,"Pharmacists in the intervention group will receive three sessions of training in line with the TGA model over one year, compared with a pharmaceutical training program in the control group without a communication component.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'School of Medical Management and Health Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. Electronic address: 815310016@qq.com.'}, {'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Medical Management and Health Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. Electronic address: liu_chenxi@hust.edu.cn.'}, {'ForeName': 'Chaojie', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Psychology and Public Health, Latrobe University, Melbourne, Victoria, Australia. Electronic address: c.liu@latrobe.edu.au.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Medical Management and Health Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. Electronic address: 2019511009@hust.edu.cn.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Medical Management and Health Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. Electronic address: xpzhang602@hust.edu.cn.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.05.013'] 3071,32591370,A multicenter phase II randomized trial of durvalumab (MEDI-4736) versus physician's choice chemotherapy in recurrent ovarian clear cell adenocarcinoma (MOCCA).,"BACKGROUND The optimal treatment of recurrent ovarian clear cell carcinoma remains unknown. There is increasing rationale to support the role of immune checkpoint inhibitors targeting the programmed cell death protein 1 (PD - 1)/programmed death-ligand 1 (PD-L1) axis in ovarian clear cell carcinoma. PRIMARY OBJECTIVE To evaluate the efficacy of durvalumab (MEDI-4736) compared with standard chemotherapy in patients with recurrent ovarian clear cell carcinoma. STUDY HYPOTHESIS Patients with recurrent ovarian clear cell carcinoma treated with durvalumab will have improved progression-free survival compared with those treated with chemotherapy of physician's choice. TRIAL DESIGN The MOCCA study is a multicenter, open-label, randomized phase II trial in patients with recurrent ovarian clear cell carcinoma, which recruited from eight sites across Gynecologic Cancer Group Singapore (GCGS), Korean Gynecologic-Oncology Group (KGOG), and Australia New Zealand Gynecological Oncology Group (ANZGOG). Enrolled patients were randomized in a 2:1 ratio to receive durvalumab or physician's choice of chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. MAJOR INCLUSION/EXCLUSION CRITERIA Eligible patients required histologically documented diagnosis of recurrent ovarian clear cell carcinoma, as evidenced by WT1 negativity. All patients must have been of Eastern Cooperative Oncology Group (ECOG) performance status 2 or better, and have had previous treatment with, and progressed or recurred after prior platinum-based chemotherapy. No more than four prior lines of treatment were allowed and prior immune checkpoint inhibitor treatment was not permitted. PRIMARY ENDPOINTS The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy. Progression-free survival was defined as the time from the first day of treatment to the first observation of disease progression, or death due to any cause, or last follow-up. SAMPLE SIZE The target sample size was 46 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS Accrual has been completed and results are expected to be presented by mid-2021. TRIAL REGISTRATION Clinicaltrials.gov: NCT03405454.",2020,"The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy.","['recurrent ovarian clear cell adenocarcinoma (MOCCA', 'patients with recurrent ovarian clear cell carcinoma', '46 patients', 'All patients must have been of Eastern Cooperative Oncology Group (ECOG) performance status 2 or better, and have had previous treatment with, and progressed or recurred after prior platinum-based chemotherapy', 'Patients with recurrent ovarian clear cell carcinoma treated with', 'patients with recurrent ovarian clear cell carcinoma, which recruited from eight sites across Gynecologic Cancer Group Singapore (GCGS), Korean Gynecologic-Oncology Group (KGOG), and Australia New Zealand Gynecological Oncology Group (ANZGOG']","['standard chemotherapy', ""durvalumab or physician's choice of chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent"", 'durvalumab', 'durvalumab (MEDI-4736', ""physician's choice chemotherapy""]","['progression-free survival', 'Progression-free survival', 'median progression-free survival']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1518693', 'cui_str': 'Clear cell adenocarcinoma of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544205', 'cui_str': 'Ovarian clear cell carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C3641122', 'cui_str': 'MEDI4736'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",46.0,0.0700606,"The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy.","[{'ForeName': 'Natalie Yl', 'Initials': 'NY', 'LastName': 'Ngoi', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Heong', 'Affiliation': 'Department of Medical Oncology, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ow', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Wen Yee', 'Initials': 'WY', 'LastName': 'Chay', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Chel Hun', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': 'Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Goss', 'Affiliation': 'Box Hill Hospital, Box Hill, Victoria, Australia.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Diana Gz', 'Initials': 'DG', 'LastName': 'Lim', 'Affiliation': 'Department of Pathology, National University Hospital, Singapore.'}, {'ForeName': 'Nivashini', 'Initials': 'N', 'LastName': 'Kaliaperumal', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Veonice B', 'Initials': 'VB', 'LastName': 'Au', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connolly', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'The Prince of Wales Hospital, Randwick, New South Wales, Australia.'}, {'ForeName': 'Kidong', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'David Sp', 'Initials': 'DS', 'LastName': 'Tan', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore david_sp_tan@nuhs.edu.sg.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001604'] 3072,32591406,No benefit of flat head positioning in early moderate-severe acute ischaemic stroke: a HeadPoST study subgroup analysis.,"BACKGROUND Although the Head Positioning in acute Stroke Trial (HeadPoST) showed no effect of the flat head position (FP; vs sitting up head position (SUP)) on functional outcome, we hypothesised that it could still offer benefits if commenced early in those with acute ischaemic stroke (AIS) of at least moderate severity. METHODS Subgroup analysis of HeadPoST in participants with National Institutes of Health Stroke Scale (NIHSS) scores ≥7, ≥10 and ≥14, randomised to FP or SUP <4.5 hours of AIS onset on functional outcomes defined by a shift in scores on the modified Rankin scale (mRS) and death/disability (mRS scores 3-6), and any cardiovascular serious adverse event. Logistic regression analyses were undertaken adjusted for study design and baseline risk factors. RESULTS There was no significant differential treatment effect in patient subgroups defined by increasing baseline NIHSS scores: adjusted OR and 95% CI for ordinal shift and binary (3-6) mRS scores: for NIHSS ≥7 (n=867) 0.92 (0.67 to 1.25) and 0.74 (0.52 to 1.04); NIHSS ≥ 10 (n=606) 0.80 (0.58 to 1.10) and 0.77 (0.49 to 1.19); NIHSS ≥14 (n=378) 0.82 (0.54 to 1.24) and 1.22 (0.69 to 2.14). CONCLUSIONS Early FP had no significant effect in patients with moderate-severe AIS. TRIAL REGISTRATION NUMBER NCT02162017.",2020,"There was no significant differential treatment effect in patient subgroups defined by increasing baseline NIHSS scores: adjusted OR and 95% CI for ordinal shift and binary (3-6) mRS scores: for NIHSS ≥7 (n=867) 0.92 (0.67 to 1.25) and 0.74 (0.52 to 1.04); NIHSS ≥ 10 (n=606) 0.80 (0.58 to 1.10) and 0.77 (0.49 to 1.19); NIHSS ≥14 (n=378) 0.82 (0.54 to 1.24) and 1.22 (0.69 to 2.14). ","['Subgroup analysis of HeadPoST in participants with National Institutes of Health Stroke Scale (NIHSS) scores ≥7, ≥10\u2009and ≥14, randomised to', 'early moderate-severe acute ischaemic stroke', 'patients with moderate-severe AIS']","['flat head positioning', 'flat head position (FP; vs sitting up head position (SUP', 'FP or SUP']","['modified Rankin scale (mRS) and death/disability (mRS scores 3-6), and any cardiovascular serious adverse event']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.223978,"There was no significant differential treatment effect in patient subgroups defined by increasing baseline NIHSS scores: adjusted OR and 95% CI for ordinal shift and binary (3-6) mRS scores: for NIHSS ≥7 (n=867) 0.92 (0.67 to 1.25) and 0.74 (0.52 to 1.04); NIHSS ≥ 10 (n=606) 0.80 (0.58 to 1.10) and 0.77 (0.49 to 1.19); NIHSS ≥14 (n=378) 0.82 (0.54 to 1.24) and 1.22 (0.69 to 2.14). ","[{'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Brunser', 'Affiliation': 'Department of General Emergency, Clínica Alemana de Santiago, Clínica Alemana Universidad del Desarrollo, Santiago, Chile abrunser2017@gmail.com.'}, {'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sidney, New South Wales, Australia.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Faculty of Medicine, Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Faculty of Medicine, Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Faculty of Medicine, Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sidney, New South Wales, Australia.'}, {'ForeName': 'Marre L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sidney, New South Wales, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sidney, New South Wales, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney Australia, Australian Catholic University, Sydney, New South Wales, Australia.""}, {'ForeName': 'Octavio', 'Initials': 'O', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service-Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, United Kingdom.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sidney, New South Wales, Australia.'}]",Stroke and vascular neurology,['10.1136/svn-2020-000387'] 3073,32591417,"10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial.","BACKGROUND Various medications have been investigated for their efficacy in pain reduction during intrauterine device (IUD) insertion, but there is currently no standard recommendation. This study aimed to investigate the efficacy of 10% lidocaine spray in reducing pain during copper-containing intrauterine device (Cu-IUD) insertion. METHODS This study was a randomised, double-blind, placebo-controlled trial. Reproductive-age women were randomised at a 1:1 ratio into 10% lidocaine spray or placebo spray group. A 10 cm visual analogue scale (VAS) was used to evaluate pain during several steps of the IUD insertion procedure, and after the procedure. RESULTS One hundred and twenty-four women were included and 62 women were randomised in each group. Baseline characteristics between groups were similar. The 10% lidocaine spray group demonstrated significantly lower median VAS immediately after IUD insertion than the placebo group (2.95 (IQR=1.00-5.63) vs 5.00 (IQR=3.35-7.00), respectively; p=0.002). Similarly, women receiving 10% lidocaine spray reported significantly lower median VAS than those receiving placebo during tenaculum use and uterine sounding. The maximum median VAS occurred immediately after Cu-IUD insertion. The proportion of women who reported VAS≥4 during uterine sounding and after IUD placement was significantly lower in the 10% lidocaine group than in the placebo group (p<0.05). Median change in VAS from baseline to IUD placement was significantly different between 10% lidocaine spray group and placebo group (1.85 (IQR=0.08-4.03) vs 3.6 (IQR=2.40-5.80), respectively; p=0.004). CONCLUSION 10% lidocaine spray was found to be an effective local anaesthetic method for reducing pain during insertion of Cu-IUD. TRIAL REGISTRATION NUMBER Clinicaltrials.gov NCT03870711.",2020,"10% lidocaine spray was found to be an effective local anaesthetic method for reducing pain during insertion of Cu-IUD. ","['One hundred and twenty-four women were included and 62 women', 'Reproductive-age women']","['lidocaine spray or placebo spray', 'lidocaine', 'lidocaine spray', 'placebo']","['Median change in VAS', 'pain control', 'median VAS', 'visual analogue scale (VAS', 'maximum median VAS', 'pain']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",124.0,0.851634,"10% lidocaine spray was found to be an effective local anaesthetic method for reducing pain during insertion of Cu-IUD. ","[{'ForeName': 'Nalinee', 'Initials': 'N', 'LastName': 'Panichyawat', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand nalinee.pan@mahidol.ac.th.'}, {'ForeName': 'Theethat', 'Initials': 'T', 'LastName': 'Mongkornthong', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanyarat', 'Initials': 'T', 'LastName': 'Wongwananuruk', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Korakot', 'Initials': 'K', 'LastName': 'Sirimai', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",BMJ sexual & reproductive health,['10.1136/bmjsrh-2020-200670'] 3074,32592100,Timing of cranial reconstruction after cranioplasty infections: are we ready for a re-thinking? A comparative analysis of delayed versus immediate cranioplasty after debridement in a series of 48 patients.,"The optimal management of cranioplasty infections remains a matter of debate. Most authors have suggested that the infected bone/implant removal is mandatory, combined with prolonged antibiotic therapy before reconstruction. However, failures can occur, even with 12-18-month intervals between the surgeries. Longer wait times before cranial reconstruction increase the risks of socioeconomic burdens and further complications, as observed in decompressed patients hosting shunts. In our department, we treated 48 cranioplasty infections over a period of 8 years, divided into two groups. For Group A (n = 26), the treatment consisted of cranioplasty removal and debridement, followed by a delayed reconstruction. Group B (n = 22) received 2 weeks of broad-spectrum antibiotics, followed by an ""aggressive"" field debridement and immediate cranioplasty. All patients received a minimum of 8 weeks of post-operative antibiotic therapy and were scheduled for clinic-radiological follow-ups for at least 36 months. Significant differences were observed between Groups A and B with respect to the number of failures (respectively 7 versus 1), the global operative time (significantly longer for Group B), germ identification (respectively 7 versus 13), and the overall length of hospital stay (on average, 61.04 days in Group A versus 47.41 days in Group B). Three shunted patients in Group A developed sinking flap syndrome. Shunt resetting allowed symptom control until cranioplasty in one subject, whereas two did not improve, even after reconstruction. In selected patients, an aggressive field debridement, followed by the immediate replacement of an infected cranioplasty, may represent a safe and valuable option.",2020,"Significant differences were observed between Groups A and B with respect to the number of failures (respectively 7 versus 1), the global operative time (significantly longer for Group B), germ identification (respectively 7 versus 13), and the overall length of hospital stay (on average, 61.04 days in Group A versus 47.41 days in Group B).",['48 patients'],"['2\xa0weeks of broad-spectrum antibiotics, followed by an ""aggressive"" field debridement and immediate cranioplasty']","['risks of socioeconomic burdens and further complications', 'global operative time', 'number of failures', 'sinking flap syndrome', 'overall length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0196112', 'cui_str': 'Cranioplasty'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0337201', 'cui_str': 'Sinking'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",3.0,0.0258617,"Significant differences were observed between Groups A and B with respect to the number of failures (respectively 7 versus 1), the global operative time (significantly longer for Group B), germ identification (respectively 7 versus 13), and the overall length of hospital stay (on average, 61.04 days in Group A versus 47.41 days in Group B).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Di Rienzo', 'Affiliation': 'Department of Neurosurgery, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Colasanti', 'Affiliation': 'Department of Neurosurgery, Università Politecnica delle Marche, Ancona, Italy. roberto.colasanti@gmail.com.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Gladi', 'Affiliation': 'Department of Neurosurgery, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Dobran', 'Affiliation': 'Department of Neurosurgery, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Della Costanza', 'Affiliation': 'Department of Neurosurgery, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Capece', 'Affiliation': 'Department of Neurosurgery, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Veccia', 'Affiliation': 'Department of Infectious Diseases, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Iacoangeli', 'Affiliation': 'Department of Neurosurgery, Università Politecnica delle Marche, Ancona, Italy.'}]",Neurosurgical review,['10.1007/s10143-020-01341-z'] 3075,32592218,Cardiopulmonary exercise testing in severe osteoarthritis: a crossover comparison of four exercise modalities.,"Cardiopulmonary exercise testing is performed increasingly for cardiorespiratory fitness assessment and pre-operative risk stratification. Lower limb osteoarthritis is a common comorbidity in surgical patients, meaning traditional cycle ergometry-based cardiopulmonary exercise testing is difficult. The purpose of this study was to compare cardiopulmonary exercise testing variables and subjective responses in four different exercise modalities. In this crossover study, 15 patients with osteoarthritis scheduled for total hip or knee arthroplasty (mean (SD) age 68 (7) years; body mass index 31.4 (4.1) kg.m -2 ) completed cardiopulmonary exercise testing on a treadmill, elliptical cross-trainer, cycle and arm ergometer. Mean (SD) peak oxygen consumption was 20-30% greater on the lower limb modalities (treadmill 21.5 (4.6) (p < 0.001); elliptical cross-trainer (21.2 (4.1) (p < 0.001); and cycle ergometer (19.4 (4.2) ml.min -1 .kg -1 (p = 0.001), respectively) than on the arm ergometer (15.7 (3.7) ml.min -1 .kg -1 ). Anaerobic threshold was 25-50% greater on the lower limb modalities (treadmill 13.5 (3.1) (p < 0.001); elliptical cross-trainer 14.6 (3.0) (p < 0.001); and cycle ergometer 10.7 (2.9) (p = 0.003)) compared with the arm ergometer (8.4 (1.7) ml.min -1 .kg -1 ). The median (95%CI) difference between pre-exercise and peak-exercise pain scores was greater for tests on the treadmill (2.0 (0.0-5.0) (p = 0.001); elliptical cross-trainer (3.0 (2.0-4.0) (p = 0.001); and cycle ergometer (3.0 (1.0-5.0) (p = 0.001)), compared with the arm ergometer (0.0 (0.0-1.0) (p = 0.406)). Despite greater peak exercise pain, cardiopulmonary exercise testing modalities utilising the lower limbs affected by osteoarthritis elicited higher peak oxygen consumption and anaerobic threshold values compared with arm ergometry.",2020,"Despite greater peak exercise pain, cardiopulmonary exercise testing modalities utilising the lower limbs affected by osteoarthritis elicited higher peak oxygen consumption and anaerobic threshold values compared with arm ergometry.","['15 patients with osteoarthritis scheduled for total hip or knee arthroplasty (mean (SD) age 68 (7) years; body mass index 31.4 (4.1', 'severe osteoarthritis']","['cardiopulmonary exercise testing on a treadmill, elliptical cross-trainer, cycle and arm ergometer', 'Cardiopulmonary exercise testing']","['cycle ergometer', 'median (95%CI) difference between pre-exercise and peak-exercise pain scores', 'lower limb modalities', 'Anaerobic threshold', 'peak oxygen consumption and anaerobic threshold values', 'Mean (SD) peak oxygen consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",15.0,0.0739677,"Despite greater peak exercise pain, cardiopulmonary exercise testing modalities utilising the lower limbs affected by osteoarthritis elicited higher peak oxygen consumption and anaerobic threshold values compared with arm ergometry.","[{'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Roxburgh', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Campbell', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Cotter', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Reymann', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'M J A', 'Initials': 'MJA', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gwynne-Jones', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Thomas', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",Anaesthesia,['10.1111/anae.15162'] 3076,32592261,Acute performance and physiological responses to repeated-sprint exercise in a combined hot and hypoxic environment.,"We investigated performance, energy metabolism, acid-base balance, and endocrine responses to repeated-sprint exercise in hot and/or hypoxic environment. In a single-blind, cross-over study, 10 male highly trained athletes completed a repeated cycle sprint exercise (3 sets of 3 × 10-s maximal sprints with 40-s passive recovery) under four conditions (control [CON; 20℃, 50% rH, FiO 2 : 20.9%; sea level], hypoxia [HYP; 20℃, 50% rH, FiO 2 : 14.5%; a simulated altitude of 3,000 m], hot [HOT; 35℃, 50% rH, FiO 2 : 20.9%; sea level], and hot + hypoxia [HH; 35℃, 50% rH, FiO 2 : 14.5%; a simulated altitude of 3,000 m]). Changes in power output, muscle and skin temperatures, and respiratory oxygen uptake were measured. Peak (CON: 912 ± 26 W, 95% confidence interval [CI]: 862-962 W, HYP: 915 ± 28 W [CI: 860-970 W], HOT: 937 ± 26 W [CI: 887-987 W], HH: 937 ± 26 W [CI: 886-987 W]) and mean (CON: 808 ± 22 W [CI: 765-851 W], HYP: 810 ± 23 W [CI: 765-855 W], HOT: 825 ± 22 W [CI: 781-868 W], HH: 824 ± 25 W [CI: 776-873 W]) power outputs were significantly greater when exercising in heat conditions (HOT and HH) during the first sprint (p < .05). Heat exposure (HOT and HH) elevated muscle and skin temperatures compared to other conditions (p < .05). Oxygen uptake and arterial oxygen saturation were significantly lower in hypoxic conditions (HYP and HH) versus the other conditions (p < .05). In summary, additional heat stress when sprinting repeatedly in hypoxia improved performance (early during exercise), while maintaining low arterial oxygen saturation.",2020,25 W [CI: 776-873 W]) power outputs were significantly greater when exercising in heat conditions (HOT and HH) during the first sprint (p < .05).,"['22', '10 male highly trained athletes completed a', 'hot and/or hypoxic environment', '26']","['repeated cycle sprint exercise', 'repeated-sprint exercise']","['Heat exposure (HOT and HH) elevated muscle and skin temperatures', 'low arterial oxygen saturation', 'performance, energy metabolism, acid-base balance, and endocrine responses', 'power output, muscle and skin temperatures, and respiratory oxygen uptake', 'Oxygen uptake and arterial oxygen saturation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0239930', 'cui_str': 'Heat exposure'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",10.0,0.0615615,25 W [CI: 776-873 W]) power outputs were significantly greater when exercising in heat conditions (HOT and HH) during the first sprint (p < .05).,"[{'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Kasai', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Yatsutani', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Girard', 'Affiliation': 'School of Human Science (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}]",Physiological reports,['10.14814/phy2.14466'] 3077,32592273,"Q-Switched Nd:YAG (532 nm) Laser Versus Intra-Dermal Tranexamic Acid for Treatment of Facial Ephelides: A Split Face, Randomized, Comparative Trial.","BACKGROUND AND OBJECTIVES To compare the efficacy and safety of intradermal injection of tranexamic acid (TXA) versus Q switched (QS) KTP (532 nm) in the treatment of facial ephelides. STUDY DESIGN/MATERIALS AND METHODS A randomized comparative split-face study included a total of 30 female patients with bilateral facial ephelides. One cheek was treated by intra-dermal TXA injections and the other was treated by QS-KTP (532 nm). Patient assessment was performed by photography, pigmentation area, severity index and spectrophotometry at baseline, 1 week after treatment, and 2 months after treatment. RESULTS A significant difference was found between both sides regarding the percentage change of pigmentation area, severity score (PSI) and melanin index (MI) after treatment and during follow up, favoring laser (P = 0.001). PSI decreased after treatment by 66.5% and 15.4% (laser and TXA sides respectively), further decrease after follow-up was 69.4% with laser and 26.1% with TXA. MI improved by 3.7% after KTP laser to 7.7% after follow-up and by 2.4% after TXA injections to 6.5% after follow-up. Four patients developed post-inflammatory hyperpigmentation following QS-KTP. CONCLUSION QS-KTP laser is superior to intradermal TXA injection in the treatment of facial ephelides. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,"CONCLUSION QS-KTP laser is superior to intradermal TXA injection in the treatment of facial ephelides.","['30 female patients with bilateral facial ephelides', 'Facial Ephelides']","['QS-KTP laser', 'Q-Switched Nd:YAG (532\u2009nm) Laser Versus Intra-Dermal Tranexamic Acid', 'TXA injection', 'tranexamic acid (TXA) versus Q switched (QS) KTP']","['MI', 'photography, pigmentation area,\xa0severity index and spectrophotometry', 'PSI', 'percentage change of pigmentation area,\xa0severity score (PSI) and melanin index (MI', 'post-inflammatory hyperpigmentation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0016689', 'cui_str': 'Ephelis'}]","[{'cui': 'C0392222', 'cui_str': 'Potassium titanyl phosphate laser device'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C4237836', 'cui_str': 'Tranexamic Acid Injection'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037805', 'cui_str': 'Spectrophotometric measurement'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}]",30.0,0.0350367,"CONCLUSION QS-KTP laser is superior to intradermal TXA injection in the treatment of facial ephelides.","[{'ForeName': 'Khadiga S', 'Initials': 'KS', 'LastName': 'Sayed', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Tuqan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rana F', 'Initials': 'RF', 'LastName': 'Hilal', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Lasers in surgery and medicine,['10.1002/lsm.23291'] 3078,32591464,A Phase 2 Study of Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine (GVAX) with Ipilimumab as Maintenance Treatment for Metastatic Pancreatic Cancer.,"PURPOSE This phase 2 study tested granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells (GVAX) and ipilimumab in metastatic pancreatic ductal adenocarcinoma (PDA) in the maintenance setting. METHODS Patients with PDA who were treated with front-line chemotherapy consisting of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in the metastatic setting and had ongoing response or stable disease after 8-12 doses were eligible. Patients were randomized 1:1 to treatment with GVAX and ipilimumab given every 3 weeks for 4 doses then every 8 weeks (Arm A) or to FOLFIRINOX continuation (Arm B). The primary objective was to compare overall survival (OS) between the two arms. RESULTS Eighty-two patients were included in the final analysis (Arm A: 40; Arm B: 42). The study was stopped for futility after interim analysis. Median overall survival (OS) was 9.38 months (95% CI: 5.0, 12.2) for Arm A and 14.7 months (95% CI: 11.6, 20.0) for Arm B (HR 1.75, p=0.019). Using immune related-response criteria, 2 partial responses (5.7%) were observed in Arm A and 4 (13.8%) in Arm B. GVAX + ipilimumab promoted T cell differentiation into effector memory phenotypes both in the periphery and in the tumor microenvironment and increased M1 macrophages in the tumor. CONCLUSIONS GVAX and ipilimumab maintenance therapy did not improve OS over continuation of chemotherapy and resulted in a numerically inferior survival in metastatic PDA. However, clinical responses and biological effects on immune cells were observed. Further study of novel combinations in the maintenance treatment of metastatic PDA is feasible.",2020,"Median overall survival (OS) was 9.38 months (95% CI: 5.0, 12.2) for Arm A and 14.7 months","['metastatic pancreatic ductal adenocarcinoma (PDA', 'Patients with PDA who were treated with front-line chemotherapy consisting of', 'FOLFIRINOX) in the metastatic setting and had ongoing response or stable disease after 8-12 doses were eligible', 'Metastatic Pancreatic Cancer', 'Eighty-two patients were included in the final analysis (Arm A: 40; Arm B: 42']","['GVAX and ipilimumab', 'Ipilimumab', 'Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine (GVAX', '5-fluorouracil, leucovorin, irinotecan, and oxaliplatin', 'granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells (GVAX) and ipilimumab']","['Median overall survival (OS', 'overall survival (OS', 'M1 macrophages']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0030297', 'cui_str': 'Neoplasm of pancreas'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}]",82.0,0.0811801,"Median overall survival (OS) was 9.38 months (95% CI: 5.0, 12.2) for Arm A and 14.7 months","[{'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bever', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Won Jin', 'Initials': 'WJ', 'LastName': 'Ho', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Niu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Rose M', 'Initials': 'RM', 'LastName': 'Parkinson', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Beth L', 'Initials': 'BL', 'LastName': 'Onners', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferguson', 'Affiliation': 'Oncology, Johns Hopkins University.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Wilt', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang-Gillam', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thompson', 'Affiliation': 'Pathology, JJohns Hopkins University School of Medicine.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Biostatistics, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine dle@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1025'] 3079,32591475,"Natalizumab in acute ischemic stroke (ACTION II): a randomized, placebo-controlled trial.","OBJECTIVE We evaluated the effect of two doses of natalizumab on functional outcomes in acute ischemic stroke (AIS) patients. METHODS In this double-blind phase 2b trial, AIS patients aged 18-80 years with National Institutes of Health Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg intravenous natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model; p values were not used for hypothesis testing. RESULTS An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90%, 92%, and 92%, respectively), serious adverse events (26%, 33%, and 21%, respectively), or deaths (7%, 5%, and 6%, respectively). CONCLUSIONS Natalizumab administered ≤24 hours after AIS did not improve patient outcomes. CLINICALTRIALSGOV IDENTIFIER NCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.",2020,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"['patients with AIS', 'acute ischemic stroke (AIS) patients', 'AIS patients aged 18-80 years with National Institutes of Health Stroke Scale scores of 5-23 from 53 US and European sites']","['Natalizumab', 'placebo (natalizumab', 'natalizumab or placebo, with randomization stratified by treatment window ', 'natalizumab', 'placebo']","['serious adverse events', 'deaths', 'patient outcomes', 'composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.783971,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"[{'ForeName': 'Mitchell S V', 'Initials': 'MSV', 'LastName': 'Elkind', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins) mse13@columbia.edu.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Montaner', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'Aneesh B', 'Initials': 'AB', 'LastName': 'Singhal', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Kasliwal', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Elkins', 'Affiliation': ""Columbia University, New York, NY, USA (Dr. Elkind), Imperial College London, London, UK, and Alfried-Krupp Krankenhaus, Essen, Germany (Dr. Veltkamp); Vall d'Hebron Research Institute (VHIR), Barcelona, Spain, and Institute of Biomedicine of Seville (IBiS) Stroke Programme, Seville, Spain (Dr. Montaner); University of Texas, Austin, TX, USA (Dr. Johnston); Massachusetts General Hospital, Boston, MA, USA (Dr. Singhal); University of Washington, Seattle, WA, USA (Dr. Becker); Stanford University Medical Center, Stanford Stroke Center, Stanford, CA, USA (Dr. Lansberg); Biogen, Cambridge, MA, USA, at the time of the study (Dr. Tang and Dr. Kasliwal); Biogen, Cambridge, MA, USA (Dr. Elkins).""}]",Neurology,['10.1212/WNL.0000000000010038'] 3080,32591869,Alveolar ridge dimensional changes after two socket sealing techniques. A pilot randomized clinical trial.,"OBJECTIVES This pilot study aimed to assess dimensional changes following two different alveolar socket sealing techniques. MATERIAL AND METHODS Twenty-one patients requiring tooth extraction and implant placement were randomly allocated to two different alveolar ridge preservation techniques. In the control group, demineralized bovine bone mineral (DBBM) and a gingival soft tissue punch were used to fill and seal the socket, whereas in the test group, the extraction socket was filled with DBBM and sealed with a hemostatic gelatin sponge. Digitalized impressions were taken before and 6 months after tooth extraction. The comparison was made on horizontal and vertical dimensional changes. RESULTS The mean vertical loss was 0.8 ± 0.6 mm for the control group and 0.7 ± 0.5 mm for the test one. No statistical difference was found between groups for the vertical shrinkage. The horizontal dimensional narrowing of the alveolar socket was respectively 7.1/4.0/2.5 mm at levels 1, 3, and 5 mm from a coronal reference level for the control group. The test group showed dimensional changes of 4.8/2.3/1.3 mm at the three different levels, respectively. A significant difference was found at levels 3 and 5 mm. Referring to a visual analog pain scale, patients reported more severe pain in the control group (5.7/10) when compared with the test group (2.8/10). The difference was statistically highly significant (P ≤ 0.001). CONCLUSIONS A significant difference was found between control and test groups regarding the horizontal dimensional changes and the post-operative pain. CLINICAL RELEVANCE Regarding this primary result, the socket sealing technique with a hemostatic sponge provides an effective and inexpensive protocol with less post-operative pain.",2020,"Referring to a visual analog pain scale, patients reported more severe pain in the control group (5.7/10) when compared with the test group (2.8/10).",['Twenty-one patients requiring tooth extraction and implant placement'],"['alveolar ridge preservation techniques', 'DBBM and sealed with a hemostatic gelatin sponge', 'alveolar socket sealing techniques', 'demineralized bovine bone mineral (DBBM']","['horizontal dimensional changes and the post-operative pain', 'visual analog pain scale', 'horizontal dimensional narrowing of the alveolar socket', 'Alveolar ridge dimensional changes', 'severe pain', 'mean vertical loss']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0333164', 'cui_str': 'Narrow'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",21.0,0.0591021,"Referring to a visual analog pain scale, patients reported more severe pain in the control group (5.7/10) when compared with the test group (2.8/10).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Debel', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium. maxim.debel@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Toma', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vandenberghe', 'Affiliation': 'Advimago, Center for Advanced Oral Imaging, Rue Emile Claus 42, 1050, Brussels, Belgium.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Brecx', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lasserre', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium.'}]",Clinical oral investigations,['10.1007/s00784-020-03428-9'] 3081,32591901,"Intranasal ketamine versus intravenous morphine for pain management in patients with renal colic: a double-blind, randomized, controlled trial.","BACKGROUND Urinary stones are a common urologic problem that can be manifested as an intense pain, known as renal colic. Pain control is an important intervention for the emergency treatment of renal colic patients. Intranasal ketamine can form a crucial part of such interventions by offering a new route for a widely-used analgesic drug. METHODS In a double-blind, randomized, clinical trial, adults with renal colic admitted to a tertiary hospital emergency department were examined. The intervention group received 1 mg/kg intranasal (IN) ketamine and 1 ml of saline as a placebo. The control group received 0.1 mg/kg intravenous (IV) morphine and four puffs of saline as the placebo. The pain score was measured on the Numerical Rating Scale (NRS) 0, 15, 30 and 60 min after the drug administration. RESULTS A total of 184 patients enrolled in this study in two parallel groups. The two groups did not differ significantly in terms of pain intensity at the time of their referral (P = 0.489), 15 min post-dose (P = 0.204), 30 min post-dose (P = 0.978) and 60 min post-dose (P = 0.648). CONCLUSION IN ketamine is as effective as IV morphine for pain control in renal colic patients. No remarkable side-effects were observed for IN ketamine use in these patients.",2020,"The two groups did not differ significantly in terms of pain intensity at the time of their referral (P = 0.489), 15 min post-dose (P = 0.204), 30 min post-dose (P = 0.978) and 60 min post-dose (P = 0.648). ","['adults with renal colic admitted to a tertiary hospital emergency department were examined', '184 patients enrolled in this study in two parallel groups', 'renal colic patients', 'patients with renal colic']","['0.1\xa0mg/kg intravenous (IV) morphine and four puffs of saline as the placebo', 'ketamine', 'Intranasal ketamine', '1\xa0mg/kg intranasal (IN) ketamine and 1\xa0ml of saline as a placebo', 'morphine']","['pain score', 'pain intensity', 'remarkable side-effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",184.0,0.549636,"The two groups did not differ significantly in terms of pain intensity at the time of their referral (P = 0.489), 15 min post-dose (P = 0.204), 30 min post-dose (P = 0.978) and 60 min post-dose (P = 0.648). ","[{'ForeName': 'Mahboub', 'Initials': 'M', 'LastName': 'Pouraghaei', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Moharamzadeh', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed Pouya', 'Initials': 'SP', 'LastName': 'Paknezhad', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Zahra Vand', 'Initials': 'ZV', 'LastName': 'Rajabpour', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Soleimanpour', 'Affiliation': 'Research Center for Evidence Based Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. soleimanpourh@tbzmed.ac.ir.'}]",World journal of urology,['10.1007/s00345-020-03319-4'] 3082,32591933,Can reminders improve adherence to regular physical activity and exercise recommendations in people over 60 years old? : A randomized controlled study.,"PURPOSE The purpose of the study was to investigate whether additional reminders could enhance adherence to a 12-week program consisting of regular physical activity. METHODS The study collective consisted of pensioners insured with the Austrian Insurance Fund for Civil or Public Servants. They were made aware of our program through the public service union. The subjects were randomized to an intervention group (group A) that received reminders and to a control group (group B) that did not receive such notifications. Adherence to physical activity was assessed by the use of diaries. RESULTS Group A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min). The Mann-Whitney U-test showed no significant differences (p = 0.080) between the study groups. There was no difference in muscle strengthening activity (group A: median: 2, r = 0-13 sessions; group B: median: 2, r = 0-20 sessions). CONCLUSION The major positive observation was that both the experimental and control group participants exceeded the recommended level of physical activity. Nevertheless, there were some differences concerning the minutes of physical activity performed in favor of the intervention group.",2020,"A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min).","['pensioners insured with the Austrian Insurance Fund for Civil or Public Servants', 'people over 60 years old']",['intervention group (group\xa0A) that received reminders and to a\xa0control group (group\xa0B) that did not receive such notifications'],"['muscle strengthening activity', 'moderate intensity regular physical activity', 'level of physical activity', 'Adherence to physical activity']","[{'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0253331,"A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min).","[{'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wolner-Strohmeyer', 'Affiliation': 'Wien Hauptstelle, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Vienna, Austria.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Keilani', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Mähr', 'Affiliation': 'Therapiezentrum Rosalienhof, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Bad Tatzmannsdorf, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Morawetz', 'Affiliation': 'Wien Hauptstelle, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Vienna, Austria.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Zdravkovic', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Palma', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mickel', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Galateja', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. richard.crevenna@meduniwien.ac.at.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01699-6'] 3083,32592022,Clinical features and risk factors in patients with asthma complicated with obstructive sleep apnea-hypopnea syndrome: a hospital-based study.,"PURPOSE The current study was conducted to explore the clinical features and risk factors of patients with asthma complicated by obstructive sleep apnea-hypopnea syndrome (OSAHS). METHODS Patients with asthma who underwent polysomnography in our hospital from August 2017 to December 2019 were enrolled in the study. Data on demographics, pulmonary function testing, polysomnography, blood gases, mean pulmonary artery pressure, and vascular endothelial growth factor (VEGF) were compared between the two groups. RESULTS Of 238 patients with asthma, 93 who also had OSAHS formed the observation group and were subclassified into mild (n = 33), moderate (n = 41), and severe (n = 19) categories, while 145 patients with asthma alone were assigned to the control group. No significant differences were found in sex, age, course of disease, or pulmonary function between the two groups (P > 0.05), while the observation group showed more frequent allergic rhinitis and had greater BMI, neck circumference, mean pulmonary artery pressure (mPAP), and VEGF than those in the control group (P < 0.001). The peak expiratory flow (PEF), forced expiratory volume in 1 s (FEV 1 ), forced vital capacity (FVC), and FEV 1 /FVC in the mild group and the moderate group were higher than those in the severe group (P < 0.001). The durations of AHI and SaO 2  < 90% in the mild group and the moderate group were shorter than that in the severe group, and the lowest level of SaO 2 in the mild group and the moderate group was higher than that in the severe group (P <  0.05). The mPAP and VEGF of the mild and moderate groups were lower than those of severe group (P < 0.001), with mild group lower than moderate group (P < 0.001). CONCLUSION Significant differences in allergic rhinitis, BMI, neck circumference, AHI, SaO2, mPAP, and VEGF were observed in patients with asthma complicated by OSAHS. These parameters are risk factors associated with asthma complicated by OSAHS.",2020,"The peak expiratory flow (PEF), forced expiratory volume in 1 s (FEV 1 ), forced vital capacity (FVC), and FEV 1 /FVC in the mild group and the moderate group were higher than those in the severe group (P < 0.001).","['Patients with asthma who underwent polysomnography in our hospital from August 2017 to December 2019 were enrolled in the study', 'patients with asthma complicated by obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with asthma complicated by OSAHS', 'patients with asthma complicated with obstructive sleep apnea-hypopnea syndrome', '238 patients with asthma, 93 who also had OSAHS formed the observation group and were subclassified into mild (n\xa0=\xa033), moderate (n\xa0=\xa041), and severe (n\xa0=\xa019) categories, while 145 patients with asthma alone']",[],"['BMI, neck circumference, mean pulmonary artery pressure (mPAP), and VEGF', 'allergic rhinitis, BMI, neck circumference, AHI, SaO2, mPAP, and VEGF', 'durations of AHI and SaO', 'mPAP and VEGF', 'peak expiratory flow (PEF), forced expiratory volume in 1 s (FEV 1 ), forced vital capacity (FVC), and FEV 1 /FVC', 'sex, age, course of disease, or pulmonary function', 'demographics, pulmonary function testing, polysomnography, blood gases, mean pulmonary artery pressure, and vascular endothelial growth factor (VEGF', 'frequent allergic rhinitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4517577', 'cui_str': '145'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",238.0,0.0151148,"The peak expiratory flow (PEF), forced expiratory volume in 1 s (FEV 1 ), forced vital capacity (FVC), and FEV 1 /FVC in the mild group and the moderate group were higher than those in the severe group (P < 0.001).","[{'ForeName': 'Jun-Ling', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University, No. 8 Gongti South Road, Chaoyang District, Beijing, 100020, China. cyhxsmyy@163.com.'}, {'ForeName': 'Xiao-Kai', 'Initials': 'XK', 'LastName': 'Feng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University, No. 8 Gongti South Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University, No. 8 Gongti South Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Capital Medical University, No. 8 Gongti South Road, Chaoyang District, Beijing, 100020, China.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02127-9'] 3084,32592335,Treatment of oral lichen planus with mucoadhesive mycophenolate mofetil patch: A randomized clinical trial.,"OBJECTIVES Oral lichen planus (OLP) is a chronic inflammatory disease of unknown etiology which is known as a premalignant disease. A complete cure has not been found for this condition. Mycophenolate mofetil (MMF) is a new drug that seems to be effective in improving OLP lesions. But there are no studies on the efficacy of mucoadhesive form of MMF in ulcerative OLP. Therefore, this study was performed to determine the therapeutic effect of MMF mucoadhesive on OLP lesions. MATERIAL AND METHODS Twenty-seven patients with OLP, were enrolled in two groups. All the patients were instructed to place the MMF 2% mucoadhesive on the lesion twice daily for 4 weeks. Lesion size was measured by a sterile digital caulis (mm) and the severity of burning sensation and pain by visual analogue scale (VAS; cm) at baseline and weekly follow-ups. RESULTS There was no significant difference in burning sensation and lesion size at Weeks 1, 2, and 3 in both groups. In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012). The difference in lesion size on control sides was not significant. In Group B, at Week 4, there was significant reduction in pain and burning sensation and lesion size (p = .004). No side effects were reported by the patients. CONCLUSIONS Based on the results, 2% MMF mucoadhesive was effective in decreasing burning sensation and pain severity and ulcer size of ulcerative OLP and the effect was time-dependent.",2020,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","['Twenty-seven patients with OLP, were enrolled in two groups']","['Mycophenolate mofetil (MMF', 'Oral lichen planus (OLP', 'MMF mucoadhesive', 'mucoadhesive mycophenolate mofetil patch']","['burning sensation and lesion size', 'lesion size on control sides', 'burning sensation and pain severity and ulcer size of ulcerative OLP', 'severity of burning sensation and pain by visual analogue scale (VAS; cm', 'Lesion size', 'pain and burning sensation and lesion size', 'side effects']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",27.0,0.0435425,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","[{'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Samiee', 'Affiliation': 'Post Graduate Student of Oral and Maxillofacial Medicine, Oral and Maxillofacial Medicine Department, Mashhad Dental Faculty, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghavi Zenuz', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Mehdipour', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.302'] 3085,32592369,Neoadjuvant FOLFIRINOX followed by Chemoradiotherapy for Middle and Lower Rectal Cancer.,"OBJECTIVE Neoadjuvant concomitant chemoradiotherapy followed by surgical resection is the standard of care in the treatment of rectal cancer. We are investigating the value of adding combination chemotherapy oxaliplatin, irinotecan, leucovorin and fluorouracil (FOLFIRINOX) before neoadjuvant chemoradiotherapy. METHODS Forty-one patients with middle and lower rectal cancer were included. FOLFORINOX were given every 2 weeks over 2 months (4 cycles) followed by concomitant chemoradiotherapy (CRT). Surgery was done 6-8 weeks after CRT and then adjuvant 4 months of FOLFOX or XELOX were given. The primary end point was sphincter preservation rate. RESULTS All patients received the four cycles of neoadjuvant chemotherapy FOLFORINOX, 38 patients completed CRT and only 29 patients underwent surgery. 32 patients were available for assessment (29 patients who underwent surgery and three patients who refuse surgery because of no evidence of disease by endoscopy, imaging and biopsy). Sphincter preservation was achieved in twenty-one patients (51.2%). Pathological complete response rate was 24.1%. After a median follow up of 24 months. Median PFS was 20 months and 2-years PFS was 62.3%. The median overall survival of all patients was not reached, while 2-years OS was 76.5%. CONCLUSION Neoadjuvant FOLFIRINOX followed by CRT for middle and lower rectal cancer is feasible, tolerable with satisfactory sphincter preservation rate. 
.",2020,"The median overall survival of all patients was not reached, while 2-years OS was 76.5%. ","['38 patients completed CRT and only 29 patients underwent surgery', '32 patients were available for assessment (29 patients who underwent surgery and three patients who refuse surgery because of no evidence of disease by endoscopy, imaging and biopsy', 'Forty-one patients with middle and lower rectal cancer were included', 'Middle and Lower Rectal Cancer', 'rectal cancer']","['Neoadjuvant concomitant chemoradiotherapy', 'combination chemotherapy oxaliplatin, irinotecan, leucovorin and fluorouracil (FOLFIRINOX) before neoadjuvant chemoradiotherapy', 'FOLFOX or XELOX', 'concomitant chemoradiotherapy (CRT', 'neoadjuvant chemotherapy']","['Median PFS', 'Pathological complete response rate', 'sphincter preservation rate', 'median overall survival', 'Sphincter preservation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",41.0,0.0860488,"The median overall survival of all patients was not reached, while 2-years OS was 76.5%. ","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'Elsherbiny', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Beni Suef University, Egypt.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'Abdel Moneim', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shaaban', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Beni Suef University, Egypt.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Aldaly', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1717'] 3086,32592381,Randomized Pilot Study of 20 Gy in 5 Fractions versus 27 Gy in 3 Fractions Radiotherapy for Treating Painful Bone Metastases: A Single Institution Experience.,"PURPOSE Radiotherapy is a very effective tool in the treatment of painful bone metastases. The aim of this study was to compare the palliative effect of radiotherapy between the standard fractionation schedule 20 Gy over 5 fractions (20Gy/5fr) and the high biological dose schedule 27 Gy over 3 fractions (27Gy/3fr) which is frequently used in Stereotactic body radio-surgery (SBRT). METHODS Patients were randomized to receive (20Gy/5fr)or (27Gy/3fr). The primary aim of the study was pain relief using the numeric rating scale (NRS), after three months of radiation therapy. Secondary end points include pain relief immediately after finishing radiation therapy (within one week), and narcotic relief after three months of radiation therapy. RESULTS Twenty-two patients with painful bone metastases were included. 12 patients received (20Gy/5fr) and 10 patients received (27Gy/3fr). Male patients were predominant on both arms (81.8%) with a mean age of 58 years [ranging between 19-72 years]. For pain relief after three months of radiation therapy, partial pain relief was documented in 9 patients (75%) with (20Gy/5fr) and in 8 patients (80%) with (27Gy/3fr) with a p- value of 0.6. Additionally, narcotic relief after three months was equal for both groups. For immediate pain relief, partial pain relief was seen in one patient (8%) with (20Gy/5fr) versus seven patients (70%) with (27Gy/3fr) with a p value of 0.06. The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant. CONCLUSION SBRT and standard fractionation radiation therapy had equal effectiveness for pain relief, when the assessment was done after three months of radiation therapy. Interestingly, SBRT had a better immediate pain relief. 
.",2020,"The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant. ","['Male patients were predominant on both arms (81.8%) with a mean age of 58 years [ranging between 19-72 years', '12 patients received (20Gy/5fr) and 10 patients received (27Gy/3fr', 'painful bone metastases', 'Twenty-two patients with painful bone metastases', 'Patients were randomized to receive (20Gy/5fr)or (27Gy/3fr']","['radiotherapy', '20 Gy in 5 Fractions versus 27 Gy in 3 Fractions Radiotherapy', 'SBRT and standard fractionation radiation therapy', 'SBRT', 'Radiotherapy']","['partial pain relief', 'pain relief', 'immediate pain relief', 'pain relief using the numeric rating scale (NRS', 'narcotic relief', 'immediate pain relief, partial pain relief']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",22.0,0.0383319,"The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant. ","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Wedad Bassam', 'Initials': 'WB', 'LastName': 'Hashem', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Karim Nabil', 'Initials': 'KN', 'LastName': 'Mashhour', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1807'] 3087,32592382,Effect of a Pedometer-based Exercise Program on Cancer Related Fatigue and Quality of Life amongst Patients with Breast Cancer Receiving Chemotherapy.,"BACKGROUND Breast cancer is the most common cancer amongst Indian women. Cancer treatments leads to various side effects out of which Cancer-Related fatigue (CRF) is one of the most under-addressed side-effects. It is experienced the most in patients receiving chemotherapy. Exercise has been proven to be a beneficial intervention to manage CRF but the benefits of pedometer-based exercise programs is under-studied in patients with breast cancer. Hence, we set out to investigate the effects of a pedometer-based exercise program for patients with breast receiving chemotherapy. METHODS The current study was a non-randomized controlled trial with 22 patients each in exercise and control group. The exercise group received a pedometer-based walking program, whereas the control group received standard physical activity advice. Fatigue, quality of life, functional capacity and body composition were assessed at baseline, 3rd week and 7th week. RESULTS At the end of 7 weeks intervention, functional capacity, quality of life and skeletal mass were found to have improved with statistical significance, while the fatigue and changes in total fat did improve but were not statistically significant. CONCLUSION A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.",2020,"A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.","['patients with breast receiving chemotherapy', 'Indian women', 'Patients with Breast Cancer', '22 patients each in exercise and control group', 'patients with breast cancer', 'patients receiving chemotherapy', 'patients with breast cancer receiving chemotherapy']","['pedometer-based walking program, whereas the control group received standard physical activity advice', 'Pedometer-based Exercise Program', 'Chemotherapy', 'pedometer-based exercise program']","['Cancer Related Fatigue and Quality of Life', 'Fatigue, quality of life, functional capacity and body composition', 'functional capacity, quality of life and skeletal mass', 'functional capacity, quality of life and percentage of skeletal mass', 'fatigue and changes in total fat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",22.0,0.0245141,"A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.","[{'ForeName': 'Aagna', 'Initials': 'A', 'LastName': 'Gandhi', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Stephen Rajan', 'Initials': 'SR', 'LastName': 'Samuel', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'K Vijaya', 'Initials': 'KV', 'LastName': 'Kumar', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Pu Prakash', 'Initials': 'PP', 'LastName': 'Saxena', 'Affiliation': 'Department of Radiation oncology, Kasturba Medical College, Manipal Academy of Higher education, Mangalore, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Mithra', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1813'] 3088,32592516,A Randomized Sham-Controlled Cross-Over Study on the Short-Term Effect of Non-Invasive Cervical Vagus Nerve Stimulation on Spinal and Supraspinal Nociception in Healthy Subjects.,"OBJECTIVE The aim of the present study was to test the effects of vagus nerve stimulation (VNS) on the descending pain inhibition, quantified by the nociceptive flexor (RIII) reflex and the conditioned pain modulation (CPM) paradigm, and on supraspinal nociceptive responses, assessed by pain intensity and unpleasantness ratings and late somatosensory evoked potentials (SEPs), in healthy subjects. BACKGROUND Non-invasive vagus nerve stimulation (nVNS) showed promising effects on headache and pain treatment. Underlying mechanisms are only incompletely understood but may include the activation of the descending pain inhibitory system and/or the modification of emotional responses to pain. METHODS Twenty-seven adult, healthy, and pain-free subjects participated in this double-blind cross-over study conducted at a university research center. They received 4 minutes of cervical nVNS or sham stimulation in randomized order. RIII reflexes, pain ratings, and SEPs were assessed before, during, and 5, 15, 30, and 60 minutes after nVNS/sham stimulation, followed by CPM testing. The primary outcome was the nVNS effect on the RIII reflex size. Three subjects were excluded after the preparatory session (before randomization), 1 subject was excluded after outlier analysis, leaving 23 for analysis. RESULTS RIII reflex areas were 917.1 ± 563.8 µV × ms (mean ± SD) before, 952.4 ± 467.4 µV × ms during and 929.2 ± 484.0 µV × ms immediately after nVNS and 858.4 ± 489.2 µV × ms before, 913.9 ± 539.7 µV × ms during and 862.4 ± 476.0 µV × ms after sham stimulation, revealing no differences between the immediate effects of nVNS and sham stimulation (F [3,66]  = 0.67, P = .574). There also were no effects of nVNS over sham on RIII reflex areas up to 60 minutes after nVNS (F [1.7,37.4]  = 1.29, P = .283). Similarly, there was no statistically significant effect of nVNS on pain intensity ratings and thresholds, RIII reflex thresholds, late SEP amplitudes, and the CPM effect, compared to sham. Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F [1,22]  = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation). CONCLUSIONS The present study does not support an acute effect of nVNS on descending pain inhibition, pain intensity perception or supraspinal nociception in healthy adults. However, there was a small effect on pain unpleasantness during nVNS, suggesting that nVNS may preferentially act on affective, not somatosensory pain components.",2020,"Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F [1,22]  = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation). ","['RIII reflex areas were 917.1\xa0±\xa0563.8', '476.0', 'healthy subjects', 'Twenty-seven adult, healthy, and pain-free subjects participated in this double-blind cross-over study conducted at a university research center', 'healthy adults', 'Healthy Subjects']","['Non-Invasive Cervical Vagus Nerve Stimulation', 'vagus nerve stimulation (VNS', 'nVNS', 'Non-invasive vagus nerve stimulation (nVNS', 'cervical nVNS or sham stimulation']","['nVNS effect on the RIII reflex size', 'headache and pain treatment', 'Spinal and Supraspinal Nociception', 'RIII reflexes, pain ratings, and SEPs', 'Pain unpleasantness ratings', 'pain intensity ratings and thresholds, RIII reflex thresholds, late SEP amplitudes, and the CPM effect', 'pain unpleasantness', 'pain intensity and unpleasantness ratings and late somatosensory evoked potentials (SEPs', 'RIII reflex areas', 'mean\xa0±\xa0SD', 'nociceptive flexor (RIII) reflex and the conditioned pain modulation (CPM']","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0277847', 'cui_str': 'Flexion spinal defense reflex'}]",3.0,0.21542,"Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F [1,22]  = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation). ","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Alt', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wach', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Liebler', 'Affiliation': 'electroCore, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Straube', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ruscheweyh', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}]",Headache,['10.1111/head.13891'] 3089,32592534,Effects of a Rhodiola rosea extract on mental resource allocation and attention: An event-related potential dual task study.,"Rhodiola rosea extract is widely used to alleviate stress and improve cognition and mental resources. A total of 50 adult participants were treated with 2 × 200 mg R. rosea extract (Rosalin®, WS® 1,375) for 12 weeks and were subjected to a neuropsychological test battery as well as an event-related brain potential measurement in a dual task paradigm prior to administration, after 6 weeks and after 12 weeks. The study followed a single-arm open-label design. Reaction times improved for the attention network task (ANT), the Go/Nogo task, and the divided attention task. Moreover, the orienting effect and the executive effect in the ANT showed an improvement. The P3 component in a dual task paradigm was increased in amplitude. The results of this pilot study show an improvement of mental speed and moreover, suggest improved mental resources. As the current study is single-armed these findings need to be replicated in a double-blind placebo controlled study.",2020,"Reaction times improved for the attention network task (ANT), the Go/Nogo task, and the divided attention task.",['50 adult participants'],"['2 ×\u2009200\u2009mg R. rosea extract (Rosalin®, WS® 1,375) for 12\u2009weeks and were subjected to a neuropsychological test battery as well as an event-related brain potential measurement', 'Rhodiola rosea extract']","['mental resource allocation and attention', 'orienting effect and the executive effect', 'Reaction times']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0950014', 'cui_str': 'Roseroot'}]","[{'cui': 'C0086914', 'cui_str': 'Allocation of Resources'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",50.0,0.0465909,"Reaction times improved for the attention network task (ANT), the Go/Nogo task, and the divided attention task.","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Koop', 'Affiliation': 'Department of Neurology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Dienel', 'Affiliation': 'Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Heldmann', 'Affiliation': 'Department of Neurology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Münte', 'Affiliation': 'Department of Neurology, University of Lübeck, Lübeck, Germany.'}]",Phytotherapy research : PTR,['10.1002/ptr.6778'] 3090,32182276,Does the combination of different pitches and the absence of pitch type information influence timing control during batting in baseball?,"Baseball pitchers use various pitch types to reduce hitting accuracy, but little is understood of the practical strategy of using visuomotor skills and timing control to respond to different pitches. This study examined 1) effectiveness of pitch type combinations, and 2) relationship between the presence and absence of advance information about the next pitch and the timing error. Twenty-six high school baseball players hit a ball launched from a pitching machine in a combination of fastballs (34.3±1.3 m·s-1), curveballs (25.4±1.0 m·s-1), and slowballs (25.5±0.9 m·s-1). Each participant performed three conditions. (1) Continuity condition (15 trials), in which the same pitch type was thrown five times consecutively. (2) Random condition (30 trials), in which pitch type was not preliminarily conveyed to the participants. (3) Open condition (20 trials), in which the next pitch type was preliminarily conveyed to participants. Participants' hitting movement was recorded by an optical motion capture system and force platform. We calculated timing error based on the difference between the measured impact location (ball position relative to the batter's body at ball-bat impact) and optimal impact location. The timing error between n-th pitch type, (n-1)-th pitch, and the presence or absence of advance information about pitch type (open vs random condition) were analyzed using three-way repeated ANOVA. The results showed that the (n-1)-th pitch type did not affect the timing of impact (p = 0.338). In contrast, the timing errors in open conditions were fewer compared to random conditions (p < 0.001). These results indicate that the pitch type sequence has insignificant effects, and advance information about pitches affects the timing errors. Therefore, having two or more pitch types, reducing the fluctuation of the pitching motion, and the early trajectory of the ball between different pitches potentially lead to increase timing errors.",2020,"In contrast, the timing errors in open conditions were fewer compared to random conditions (p < 0.001).","['Twenty-six high school baseball players hit a ball launched from a pitching machine in a combination of fastballs (34.3±1.3 m·s-1), curveballs (25.4±1.0 m·s-1), and slowballs (25.5±0.9 m·s-1']",[],['hitting movement'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",[],"[{'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",26.0,0.0324772,"In contrast, the timing errors in open conditions were fewer compared to random conditions (p < 0.001).","[{'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kidokoro', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, Kita-ku, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, Kita-ku, Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Akagi', 'Affiliation': 'College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Saitama, Japan.'}]",PloS one,['10.1371/journal.pone.0230385'] 3091,31272313,Analysis of the Impact of Antiretroviral Drug Changes on Survival of Patients with Advanced-Stage AIDS with Multidrug-Resistant HIV Infection.,"OBJECTIVES This article aims to elucidate the relationship between antiretroviral (ARV) medication changes and all-cause mortality using a total of 368 patients recruited from the United States (78%), United Kingdom (11%), and Canada (11%). METHODS Data sources included demographic characteristics, ARV treatment history and modifications, and clinical biomarker data from the completed OPTions In Management with Antiretrovirals clinical trial. Descriptive analysis and graphical trajectory representation of ARV drug modifications and biomarker changes were undertaken. Three hypotheses aimed at assessing the impact of ARV modification parameters on clinical outcomes were tested. Kaplan-Meier survival techniques as well as Cox proportional hazard regression models were employed. RESULTS Results from the analyses suggest that (1) switching therapy strategy from an intensified ARV regimen to a less intense one or vice versa, (2) having a moderate number (up to 2) of ARV drug changes per 6 months, and (3) changes based on clinical/HIV-related reasons or nonclinical reasons compared to ARV drug regimen changes due to clinical non-HIV reasons improved survival. CONCLUSION Modifications in the ARV regimens of HIV-infected patients with multidrug resistance are associated with improved survival.",2019,"RESULTS Results from the analyses suggest that (1) switching therapy strategy from an intensified ARV regimen to a less intense one or vice versa, (2) having a moderate number (up to 2) of ARV drug changes per 6 months, and (3) changes based on clinical/HIV-related reasons or nonclinical reasons compared to ARV drug regimen changes due to clinical non-HIV reasons improved survival. ","['Patients with Advanced-Stage AIDS with Multidrug-Resistant HIV Infection', '368 patients recruited from the United States (78%), United Kingdom (11%), and Canada (11']",[],['survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}]",368.0,0.165269,"RESULTS Results from the analyses suggest that (1) switching therapy strategy from an intensified ARV regimen to a less intense one or vice versa, (2) having a moderate number (up to 2) of ARV drug changes per 6 months, and (3) changes based on clinical/HIV-related reasons or nonclinical reasons compared to ARV drug regimen changes due to clinical non-HIV reasons improved survival. ","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': '1 Department of Biostatistics, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Tae Hyun', 'Initials': 'TH', 'LastName': 'Jung', 'Affiliation': '1 Department of Biostatistics, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Peduzzi', 'Affiliation': '1 Department of Biostatistics, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Sheldon T', 'Initials': 'ST', 'LastName': 'Brown', 'Affiliation': '3 James J. Peters VA Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Tassos C', 'Initials': 'TC', 'LastName': 'Kyriakides', 'Affiliation': '2 VA Cooperative Studies Program Coordinating Center, West Haven, CT, USA.'}]",Journal of the International Association of Providers of AIDS Care,['10.1177/2325958219849101'] 3092,31396621,Information Diffusion and Social Norms Are Associated with Infant and Young Child Feeding Practices in Bangladesh.,"BACKGROUND Interaction within mothers' social networks can theoretically diffuse messages from interventions and campaigns into norms and practices for infant and young child feeding (IYCF). OBJECTIVES We hypothesized that mothers' social networks, diffusion of information, and social norms differed in intensive [intensive interpersonal counseling (IPC), community mobilization (CM), and mass media (MM)] compared with nonintensive (standard IPC and less-intensive CM and MM) intervention areas, were associated with IYCF practices, and partly explained practice improvement. METHODS We conducted household surveys at endline in 2014 and follow-up in 2016 (n = ∼2000 each round). We used multiple regression to test differences and changes in networks, diffusion, and norms within intervention areas. We analyzed paths from intervention exposure to IYCF practices through networks, diffusion, and norms. RESULTS Mothers' networks were larger in intensive than in nonintensive areas in 2014 and increased in both areas over time [25-38 percentage points (pp)]. The prevalence of receipt of IYCF information was high, with no changes over time in intensive areas but an increase in nonintensive areas (8-16 pp). In both areas, more family members and health workers provided IYCF information over time. Sharing of information increased 17-23 pp in intensive and 11-41 pp in nonintensive areas over time. Perceived descriptive norms improved 8-16 pp in intensive and 17-28 pp in nonintensive areas. Perceived injunctive norms were high in both areas. Breastfeeding practices were associated with networks, diffusion, and norms (OR: 1.6-4.4 times larger comparing highest with lowest quartile). Minimum dietary diversity was associated with larger networks and diffusion (OR: 1.5-2.2) but not with social norms. Indirect paths from intervention exposure to practices explained 34-78% of total effects. CONCLUSIONS Diffusion of IYCF information through social networks, reinforced by positive social norms for messages promoted over time, will contribute to positive changes in IYCF practices that may be achieved and sustained through large-scale social and behavior change interventions. This trial was registered at clinicaltrials.gov as NCT0274084.",2019,Minimum dietary diversity was associated with larger networks and diffusion (OR: 1.5-2.2) but not with social norms.,"['Infant and Young Child Feeding Practices in Bangladesh', 'household surveys at endline in 2014 and follow-up in 2016 (n = ∼2000 each round']",[],"['intensive [intensive interpersonal counseling (IPC), community mobilization (CM), and mass media (MM']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}]",[],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]",,0.0476992,Minimum dietary diversity was associated with larger networks and diffusion (OR: 1.5-2.2) but not with social norms.,"[{'ForeName': 'Phuong H', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'FHI 360, Washington, DC, USA.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}, {'ForeName': 'Amanda A', 'Initials': 'AA', 'LastName': 'Zongrone', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Jilani', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}, {'ForeName': 'Lan Mai', 'Initials': 'LM', 'LastName': 'Tran', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sanghvi', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Menon', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz167'] 3093,32330237,Neonatal diet alters fecal microbiota and metabolome profiles at different ages in infants fed breast milk or formula.,"BACKGROUND Neonatal diet has a large influence on child health and might modulate changes in fecal microbiota and metabolites. OBJECTIVES The aim is to investigate fecal microbiota and metabolites at different ages in infants who were breastfed (BF), received dairy-based milk formula (MF), or received soy-based formula (SF). METHODS Fecal samples were collected at 3 (n = 16, 12, and 14, respectively), 6 (n = 20, 19, and 15, respectively), 9 (n = 12, 11, and 12, respectively), and 12 mo (n = 14, 14, and 15, respectively) for BF, MF, and SF infants. Infants that breastfed until 9 mo and switched to formula were considered as no longer breastfeeding at 12 mo. Microbiota data were obtained using 16S ribosomal RNA sequencing. Untargeted metabolomics was conducted using a Q-Exactive Hybrid Quadrupole-Orbitrap mass spectrometer. The data were analyzed using R (version 3.6.0) within the RStudio (version 1.1.463) platform. RESULTS At 3, 6, and 9 mo of age BF infants had the lowest α-diversity, SF infants had the highest diversity, and MF was intermediate. Bifidobacterium was 2.6- to 5-fold lower in SF relative to BF infants through 1 y of life. An unidentified genus from Ruminococcaceae higher in the SF (2%) than in the MF (0.4%) and BF (0.08%) infants at 3 mo of age was observed. In BF infants higher levels of butyric acid, d-sphingosine, kynurenic acid, indole-3-lactic acid, indole-3-acetic acid, and betaine were observed than in MF and SF infants. At 3 mo Ruminococcaceae was positively correlated to azelaic, gentisic, isocitric, sebacic, and syringic acids. At 6 mo Oscillospira was negatively correlated with 3-hydroxybutyric-acid, hydroxy-hydrocinnamic acid, and betaine whereas Bifidobacterium was negatively associated with 5-hydroxytryptamine. At 12 mo of age, Lachnospiraceae was negatively associated with hydroxyphenyllactic acid. CONCLUSIONS Infant diet has a large impact on the fecal microbiome and metabolome in the first year of life.This study was registered at clinicaltrials.gov as NCT00616395.",2020,"In BF infants higher levels of butyric acid, d-sphingosine, kynurenic acid, indole-3-lactic acid, indole-3-acetic acid, and betaine were observed than in MF and SF infants.","['Fecal samples were collected at 3 (n\xa0=\xa016, 12, and 14, respectively), 6 (n\xa0=\xa020, 19, and 15, respectively), 9 (n\xa0=\xa012, 11, and 12, respectively), and 12 mo (n\xa0=\xa014, 14, and 15, respectively) for BF, MF, and SF infants', 'at different ages in infants who were breastfed (BF), received', 'infants fed breast milk or formula']","['5-hydroxytryptamine', 'dairy-based milk formula (MF), or received soy-based formula (SF']","['Bifidobacterium', '3-hydroxybutyric-acid, hydroxy-hydrocinnamic acid, and betaine whereas Bifidobacterium', 'butyric acid, d-sphingosine, kynurenic acid, indole-3-lactic acid, indole-3-acetic acid, and betaine', 'azelaic, gentisic, isocitric, sebacic, and syringic acids', 'fecal microbiota and metabolites']","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C3853245', 'cui_str': 'Soy-based formula'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C3853245', 'cui_str': 'Soy-based formula'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0047456', 'cui_str': '(+ -)-3-Hydroxybutyric Acid'}, {'cui': 'C0047696', 'cui_str': '3-phenylpropionic acid'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0037907', 'cui_str': 'Sphingosine'}, {'cui': 'C0022816', 'cui_str': 'Kynurenic acid'}, {'cui': 'C0063493', 'cui_str': 'indole-3-lactic acid'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}, {'cui': 'C0075709', 'cui_str': 'syringic acid'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0383852,"In BF infants higher levels of butyric acid, d-sphingosine, kynurenic acid, indole-3-lactic acid, indole-3-acetic acid, and betaine were observed than in MF and SF infants.","[{'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Brink', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Mercer', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Piccolo', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Sree V', 'Initials': 'SV', 'LastName': 'Chintapalli', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elolimy', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Bowlin', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Katelin S', 'Initials': 'KS', 'LastName': 'Matazel', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pack', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Sean H', 'Initials': 'SH', 'LastName': 'Adams', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Shankar', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Badger', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Andres', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}, {'ForeName': 'Laxmi', 'Initials': 'L', 'LastName': 'Yeruva', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, AR, USA.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa076'] 3094,32445688,"Cognitive behavioural therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial.","BACKGROUND Dissociative seizures are paroxysmal events resembling epilepsy or syncope with characteristic features that allow them to be distinguished from other medical conditions. We aimed to compare the effectiveness of cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone for the reduction of dissociative seizure frequency. METHODS In this pragmatic, parallel-arm, multicentre randomised controlled trial, we initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales. Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months were subsequently randomly assigned (1:1) from 17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system. Randomisation was stratified by neuropsychiatry or liaison psychiatry recruitment site. The trial manager, chief investigator, all treating clinicians, and patients were aware of treatment allocation, but outcome data collectors and trial statisticians were unaware of treatment allocation. Patients were followed up 6 months and 12 months after randomisation. The primary outcome was monthly dissociative seizure frequency (ie, frequency in the previous 4 weeks) assessed at 12 months. Secondary outcomes assessed at 12 months were: seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom in the previous 3 months; a greater than 50% reduction in seizure frequency relative to baseline; changes in dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction. p values and statistical significance for outcomes were reported without correction for multiple comparisons as per our protocol. Primary and secondary outcomes were assessed in the intention-to-treat population with multiple imputation for missing observations. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN05681227, and ClinicalTrials.gov, NCT02325544. FINDINGS Between Jan 16, 2015, and May 31, 2017, we randomly assigned 368 patients to receive CBT plus standardised medical care (n=186) or standardised medical care alone (n=182); of whom 313 had primary outcome data at 12 months (156 [84%] of 186 patients in the CBT plus standardised medical care group and 157 [86%] of 182 patients in the standardised medical care group). At 12 months, no significant difference in monthly dissociative seizure frequency was identified between the groups (median 4 seizures [IQR 0-20] in the CBT plus standardised medical care group vs 7 seizures [1-35] in the standardised medical care group; estimated incidence rate ratio [IRR] 0·78 [95% CI 0·56-1·09]; p=0·144). Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53 [95% CI -0·97 to -0·08]; p=0·020). The CBT plus standardised medical care group had a longer period of dissociative seizure freedom in the previous 6 months (estimated IRR 1·64 [95% CI 1·22 to 2·20]; p=0·001), reported better health-related quality of life on the EuroQoL-5 Dimensions-5 Level Health Today visual analogue scale (estimated mean difference 6·16 [95% CI 1·48 to 10·84]; p=0·010), less impairment in psychosocial functioning on the Work and Social Adjustment Scale (estimated mean difference -4·12 [95% CI -6·35 to -1·89]; p<0·001), less overall psychological distress than the standardised medical care group on the Clinical Outcomes in Routine Evaluation-10 scale (estimated mean difference -1·65 [95% CI -2·96 to -0·35]; p=0·013), and fewer somatic symptoms on the modified Patient Health Questionnaire-15 scale (estimated mean difference -1·67 [95% CI -2·90 to -0·44]; p=0·008). Clinical improvement at 12 months was greater in the CBT plus standardised medical care group than the standardised medical care alone group as reported by patients (estimated mean difference 0·66 [95% CI 0·26 to 1·04]; p=0·001) and by clinicians (estimated mean difference 0·47 [95% CI 0·21 to 0·73]; p<0·001), and the CBT plus standardised medical care group had greater satisfaction with treatment than did the standardised medical care group (estimated mean difference 0·90 [95% CI 0·48 to 1·31]; p<0·001). No significant differences in patient-reported seizure severity (estimated mean difference -0·11 [95% CI -0·50 to 0·29]; p=0·593) or seizure freedom in the last 3 months of the study (estimated odds ratio [OR] 1·77 [95% CI 0·93 to 3·37]; p=0·083) were identified between the groups. Furthermore, no significant differences were identified in the proportion of patients who had a more than 50% reduction in dissociative seizure frequency compared with baseline (OR 1·27 [95% CI 0·80 to 2·02]; p=0·313). Additionally, the 12-item Short Form survey-version 2 scores (estimated mean difference for the Physical Component Summary score 1·78 [95% CI -0·37 to 3·92]; p=0·105; estimated mean difference for the Mental Component Summary score 2·22 [95% CI -0·30 to 4·75]; p=0·084), the Generalised Anxiety Disorder-7 scale score (estimated mean difference -1·09 [95% CI -2·27 to 0·09]; p=0·069), and the Patient Health Questionnaire-9 scale depression score (estimated mean difference -1·10 [95% CI -2·41 to 0·21]; p=0·099) did not differ significantly between groups. Changes in dissociative seizures (rated by others) could not be assessed due to insufficient data. During the 12-month period, the number of adverse events was similar between the groups: 57 (31%) of 186 participants in the CBT plus standardised medical care group reported 97 adverse events and 53 (29%) of 182 participants in the standardised medical care group reported 79 adverse events. INTERPRETATION CBT plus standardised medical care had no statistically significant advantage compared with standardised medical care alone for the reduction of monthly seizures. However, improvements were observed in a number of clinically relevant secondary outcomes following CBT plus standardised medical care when compared with standardised medical care alone. Thus, adults with dissociative seizures might benefit from the addition of dissociative seizure-specific CBT to specialist care from neurologists and psychiatrists. Future work is needed to identify patients who would benefit most from a dissociative seizure-specific CBT approach. FUNDING National Institute for Health Research, Health Technology Assessment programme.",2020,Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53,"['patients who would benefit most from a dissociative seizure-specific CBT approach', 'Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months', 'adults with dissociative seizures (CODES', 'initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales', 'Between Jan 16, 2015, and May 31, 2017, we randomly assigned 368 patients to receive', 'group and 157 [86%] of 182 patients in the standardised medical care group', 'adults with dissociative seizures']","['CBT plus standardised medical care', '1·09', 'CBT', 'CBT plus standardised medical care (n=186) or standardised medical care alone', '17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system', 'Cognitive behavioural therapy', 'cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone']","['better health-related quality of life on the EuroQoL-5 Dimensions-5 Level Health Today visual analogue scale', 'Mental Component Summary score 2·22', 'impairment in psychosocial functioning on the Work and Social Adjustment Scale', 'dissociative seizures', 'dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction', 'dissociative seizure freedom', 'seizure severity', 'overall psychological distress', 'dissociative seizure frequency', 'Patient Health Questionnaire-9 scale depression score', 'adverse events', 'Generalised Anxiety Disorder-7 scale score', 'somatic symptoms on the modified Patient Health Questionnaire-15 scale', 'seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom', 'seizure freedom', 'monthly dissociative seizure frequency', 'Dissociative seizures', 'incidence rate ratio [IRR] 0·78', 'intention-to-treat population with multiple imputation for missing observations', 'Clinical Outcomes in Routine Evaluation-10 scale', 'number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0870956', 'cui_str': 'Neuropsychiatry'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",368.0,0.206105,Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53,"[{'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""Department of Psychology, King's College London, London, UK. Electronic address: laura.goldstein@kcl.ac.uk.""}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Robinson', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, London, UK; Institute of Psychiatry, Psychology and Neuroscience, and School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'John D C', 'Initials': 'JDC', 'LastName': 'Mellers', 'Affiliation': 'Department of Neuropsychiatry, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Medford', 'Affiliation': 'Department of Neuropsychiatry, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, King's College London, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Richardson', 'Affiliation': ""Department of Basic and Clinical Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Pilecka', 'Affiliation': ""Department of Psychology, King's College London, London, UK.""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Eastwood', 'Affiliation': ""Department of Psychology, King's College London, London, UK.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Centre for Social Justice and Global Responsibility, School of Law and Social Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Mosweu', 'Affiliation': ""King's Health Economics, King's College London, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""Department of Psychology, King's College London, London, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30128-0'] 3095,30655097,Are you watching me? The role of audience and object novelty in overimitation.,"This study tested whether overimitation is subject to an audience effect, and whether it is modulated by object novelty. A sample of 86 4- to 11-year-old children watched a demonstrator open novel and familiar boxes using sequences of necessary and unnecessary actions. The experimenter then observed the children, turned away, or left the room while the children opened the box. Children copied unnecessary actions more when the experimenter watched or when she left, but they copied less when she turned away. This parallels infant studies suggesting that turning away is interpreted as a signal of disengagement. Children displayed increased overimitation and reduced efficiency discrimination when opening novel boxes compared with familiar boxes. These data provide important evidence that object novelty is a critical component of overimitation.",2019,"Children copied unnecessary actions more when the experimenter watched or when she left, but they copied less when she turned away.",['A sample of 86 4- to 11-year-old children watched a'],['demonstrator open novel and familiar boxes using sequences of necessary and unnecessary actions'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0335296', 'cui_str': 'Demonstrator'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",[],,0.0379989,"Children copied unnecessary actions more when the experimenter watched or when she left, but they copied less when she turned away.","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Marsh', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham NG9 2RD, UK. Electronic address: lauren.marsh@nottingham.ac.uk.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ropar', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham NG9 2RD, UK.'}, {'ForeName': 'Antonia F de C', 'Initials': 'AFC', 'LastName': 'Hamilton', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham NG9 2RD, UK; Institute of Cognitive Neuroscience, University College London, London WC1N 3AZ, UK.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2018.12.010'] 3096,31092695,"Human sebum requires de novo lipogenesis, which is increased in acne vulgaris and suppressed by acetyl-CoA carboxylase inhibition.","Sebum plays important physiological roles in human skin. Excess sebum production contributes to the pathogenesis of acne vulgaris, and suppression of sebum production reduces acne incidence and severity. We demonstrate that sebum production in humans depends on local flux through the de novo lipogenesis (DNL) pathway within the sebocyte. About 80 to 85% of sebum palmitate (16:0) and sapienate (16:1n10) were derived from DNL, based on stable isotope labeling, much higher than the contribution of DNL to triglyceride palmitate in circulation (~20%), indicating a minor contribution by nonskin sources to sebum lipids. This dependence on local sebocyte DNL was not recapitulated in two widely used animal models of sebum production, Syrian hamsters and Göttingen minipigs. Confirming the importance of DNL for human sebum production, an acetyl-CoA carboxylase inhibitor, ACCi-1, dose-dependently suppressed DNL and blocked synthesis of fatty acids, triglycerides, and wax esters but not free sterols in human sebocytes in vitro. ACCi-1 dose-dependently suppressed facial sebum excretion by ~50% (placebo adjusted) in human individuals dosed orally for 2 weeks. Sebum triglycerides, wax esters, and free fatty acids were suppressed by ~66%, whereas non-DNL-dependent lipid species, cholesterol, and squalene were not reduced, confirming selective modulation of DNL-dependent lipids. Last, individuals with acne vulgaris exhibited increased sebum production rates relative to individuals with normal skin, with >80% of palmitate and sapienate derived from DNL. These findings highlight the importance of local sebocyte DNL for human skin sebaceous gland biology and illuminate a potentially exploitable therapeutic target for the treatment of acne vulgaris.",2019,dose-dependently suppressed facial sebum excretion by ~50% (placebo adjusted) in human individuals dosed orally for 2 weeks.,['human skin'],"['sebum palmitate', 'ACCi-1']","['sebum production rates', 'Sebum triglycerides, wax esters, and free fatty acids', 'Excess sebum', 'facial sebum excretion']","[{'cui': 'C3859811', 'cui_str': 'human skin preparation'}]","[{'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}]","[{'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0043076', 'cui_str': 'Wax'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.0177542,dose-dependently suppressed facial sebum excretion by ~50% (placebo adjusted) in human individuals dosed orally for 2 weeks.,"[{'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Esler', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA. william.esler@pfizer.com.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Tesz', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Marc K', 'Initials': 'MK', 'LastName': 'Hellerstein', 'Affiliation': 'KineMed Inc., Emeryville, CA 94608, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Beysen', 'Affiliation': 'KineMed Inc., Emeryville, CA 94608, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, School of Medicine, University of California, Davis, Davis, CA 95816, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Turner', 'Affiliation': 'KineMed Inc., Emeryville, CA 94608, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Watkins', 'Affiliation': 'Verso Biosciences, Davis, CA 95618, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Amor', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Carvajal-Gonzalez', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Geoly', 'Affiliation': 'Drug Safety Research and Development, Pfizer Global Research and Development, Groton, CT 06340, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Biddle', 'Affiliation': 'Drug Safety Research and Development, Pfizer Global Research and Development, Groton, CT 06340, USA.'}, {'ForeName': 'Julie J', 'Initials': 'JJ', 'LastName': 'Purkal', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fitch', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California, Berkeley, Berkeley, CA 94720, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Buckeridge', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Silvia', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Griffith', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gorgoglione', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hassoun', 'Affiliation': 'Department of Dermatology, School of Medicine, University of California, Davis, Davis, CA 95816, USA.'}, {'ForeName': 'Suzana S', 'Initials': 'SS', 'LastName': 'Bosanac', 'Affiliation': 'Department of Dermatology, School of Medicine, University of California, Davis, Davis, CA 95816, USA.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Vera', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Rolph', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Pfefferkorn', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Gabriele E', 'Initials': 'GE', 'LastName': 'Sonnenberg', 'Affiliation': 'Cardiovascular, Metabolic and Endocrine Diseases Research Unit, Pfizer Global Research and Development, Cambridge, MA 02139, USA.'}]",Science translational medicine,['10.1126/scitranslmed.aau8465'] 3097,31103781,The impact of foreign language caregiving on native language acquisition.,"There is increasing interest in the influence of language input during children's early years. Over the first 3 years of life, children are highly sensitive to the quantity and quality of language input they receive. The focus of this study was on whether learning a different language in the early years affects the acquisition of English over the longer term. In this study, we investigated effects of foreign language (Hokkien) caregiving on the eventual acquisition of English as well as on memory traces of Hokkien. We sampled individuals who received foreign language caregiving in Hokkien during their early years either predominantly or in addition to English. Our control group had lifetime primary exposure to English. We compared the Hokkien- and English-only reared groups on phonological, semantic, and grammatical knowledge in English. We also compared the groups on memories for Hokkien tonal phonology and vocabulary. Overall, there were no statistically significant differences in performance in English tasks between groups, yet the Hokkien-reared group demonstrated selective learning advantages in reacquiring Hokkien tonal contrasts. Findings are discussed with reference to the effects of timing and language input on later language proficiency.",2019,"Overall, there were no statistically significant differences in performance in English tasks between groups, yet the Hokkien-reared group demonstrated selective learning advantages in reacquiring Hokkien tonal contrasts.",['individuals who received foreign language caregiving in Hokkien during their early years either predominantly or in addition to English'],['foreign language (Hokkien) caregiving'],"['selective learning advantages', 'performance in English tasks', 'phonological, semantic, and grammatical knowledge in English']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376327', 'cui_str': 'Multinational Aspects'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0376327', 'cui_str': 'Multinational Aspects'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0278672,"Overall, there were no statistically significant differences in performance in English tasks between groups, yet the Hokkien-reared group demonstrated selective learning advantages in reacquiring Hokkien tonal contrasts.","[{'ForeName': 'Leher', 'Initials': 'L', 'LastName': 'Singh', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore 117570, Singapore. Electronic address: leher.singh@gmail.com.'}, {'ForeName': 'See Kim', 'Initials': 'SK', 'LastName': 'Seet', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore 117570, Singapore.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.04.010'] 3098,31153127,Rational imitation declines within the second year of life: Changes in the function of imitation.,"Cultural learning plays a crucial role in enabling children to fit into their social community by mastering culture-specific habits. Infants learn actions via imitation, and they seem to be sensitive to the context in which a model demonstrates these. They imitate rationally by copying unusual means to achieve a goal more when the model chooses this means voluntarily compared with when some constraints force the model to do so. We investigated the development of rational imitation. In a within-participants design, 18-, 24-, and 36-month-olds (N = 293) observed two unusual actions: Instead of using her hands, a model operated an apparatus by using her head or by sitting on the apparatus. The model did so once with her hands being occupied and once with her hands being free. Besides measuring participants' imitative responses, we analyzed the gaze behavior directed at the model during the response phase of the current study and of 14-month-olds (N = 82) from Gellén and Buttelmann's study (Child Development Research, Vol. 2017, art. 8080649 [2017]). Increasing age was accompanied by an increasing rate of overall imitation across conditions. None of the three older age groups selectively imitated the unusual actions significantly more often in the hands-free condition than in the hands-occupied condition. Thus, rational imitation seems to disappear during the second year of life. Furthermore, there was a significant increase between 14 and 24 months of age and beyond in children's tendency to gaze at the model after reenacting the observed action. Children's gaze behavior indicates that this pattern might be due to a growing underlying social component in early cultural learning.",2019,None of the three older age groups selectively imitated the unusual actions significantly more often in the hands-free condition than in the hands-occupied condition.,['8080649'],[],[],[],[],[],,0.0123554,None of the three older age groups selectively imitated the unusual actions significantly more often in the hands-free condition than in the hands-occupied condition.,"[{'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Gellén', 'Affiliation': 'Kleine Wege, Autism Advice and Support Centre, Nordhausen, Germany. Electronic address: k.gellen@kleine-wege.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Buttelmann', 'Affiliation': 'Department of Developmental Psychology, University of Bern, Bern, Switzerland.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.04.019'] 3099,32592736,In Search of Hospice Information: Consumer Information Available on Hospice Compare and Yelp.,"BACKGROUND Little is known about strategies for enrolling patients in home-based palliative care (HBPC) programs, despite the need to conduct effectiveness studies of this emerging industry. PURPOSE We used medical claims data from Accountable Care Organizations in California to identify patients for a randomized controlled trial of HBPC. We report outcomes from this strategy and the implications for future research. RESULTS Claims data identified 1,357 patients. Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients' phone numbers were missing or incorrect (16.3%). Of 371 patients reached, 163 opted out. Of 208 patients screened, 177 were ineligible for the trial. Just 10 patients were enrolled. RECOMMENDATIONS Our findings suggest that medical claims data may not be useful for engaging patients potentially eligible for palliative care research trials. We recommend that alternative identification and recruitment strategies be considered.",2020,"Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients' phone numbers were missing or incorrect (16.3%).","['371 patients reached, 163 opted out', 'Just 10 patients were enrolled', '1,357 patients', '208 patients screened, 177 were ineligible for the trial', 'enrolling patients in home-based palliative care (HBPC) programs']",['HBPC'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",[],10.0,0.055076,"Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients' phone numbers were missing or incorrect (16.3%).","[{'ForeName': 'Anna N', 'Initials': 'AN', 'LastName': 'Rahman', 'Affiliation': 'USC Leonard Davis School of Gerontology, Los Angeles, CA. Electronic address: anrahman@protonmail.com.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Enguidanos', 'Affiliation': 'USC Leonard Davis School of Gerontology, Los Angeles, CA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.06.007'] 3100,32592776,"Highly accurate artificial intelligence systems to predict the invasion depth of gastric cancer: efficacy of conventional white-light imaging, nonmagnifying narrow-band imaging, and indigo-carmine dye contrast imaging.","BACKGROUND AND AIMS Diagnosing the invasion depth of gastric cancer (GC) is necessary to determine the optimal method of treatment. Although the efficacy of evaluating macroscopic features and EUS has been reported, there is a need for more accurate and objective methods. The primary aim of this study was to test the efficacy of novel artificial intelligence systems in predicting the invasion depth of GC. METHODS A total of 16557 images from 1084 cases of GC for which endoscopic resection or surgery was performed between January 2013 and June 2019 were extracted. Cases were randomly assigned to training and test datasets at a ratio of 4:1. Through transfer learning leveraging a convolutional neural network architecture, ResNet50, 3 independent AI systems were developed. Each system was trained to predict the invasion depth of GC using conventional white-light imaging (WLI), nonmagnifying narrow-band imaging (NBI) and indigo-carmine dye contrast imaging (Indigo), respectively. RESULTS The area under the curve of the WLI AI system was 0.9590. The lesion-based sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the WLI AI system were 84.4%, 99.4%, 94.5%, 98.5%, and 92.9%, respectively. The lesion-based accuracy of the WLI, NBI, and Indigo AI systems were 94.5%, 94.3%, and 95.5%, respectively, with no significant difference. CONCLUSION These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy. The lesion-based accuracy of the WLI, NBI, and Indigo AI systems were not significantly different.",2020,These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy.,['A total of 16557 images from 1084 cases of GC for which endoscopic resection or surgery was performed between January 2013 and June 2019 were extracted'],"['GC using conventional white-light imaging (WLI), nonmagnifying narrow-band imaging (NBI) and indigo-carmine dye contrast imaging (Indigo), respectively', 'novel artificial intelligence systems', 'conventional white-light imaging, nonmagnifying narrow-band imaging, and indigo-carmine dye contrast imaging']","['lesion-based accuracy of the WLI, NBI, and Indigo AI systems', 'lesion-based sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the WLI AI system']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",16557.0,0.0451834,These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy.,"[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Nagao', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo. Electronic address: ytsuji-tky@umin.ac.jp.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Minatsuki', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Niimi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Hiroharu', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Nobutake', 'Initials': 'N', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Seto', 'Affiliation': 'Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Tada', 'Affiliation': 'Department of Surgical Oncology, Graduate School of Medicine, The University of Tokyo; AI Medical Service Inc; Tada Tomohiro Institute of Gastroenterology and Proctology.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Koike', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.047'] 3101,32592830,Cluster-sets resistance training induce similar functional and strength improvements than the traditional method in postmenopausal and elderly women.,"OBJECTIVE The aim of this study was to compare the effects of 12 weeks of traditional resistance training (TRT) or resistance training using Cluster-set (CS) on functional performance and physical fitness of postmenopausal and elderly women. METHODS Participants (61.1 ± 4.9 years, body mass 64.5 ± 1.8 kg, height 155.7 ± 4.7 cm) were randomized to TRT (n = 35) or CS (n = 31). Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests were performed before and after 12 weeks of training. The difference between protocols was the structure of rest intervals. The TRT group performed 120 s of rest between sets of 8 repetitions, while the CS performed 30 s of rest after every 2 repetitions. Two-way ANOVA with repeated measures was applied for each variable and, when needed, the Bonferroni post hoc was used. Statistical significance was set at p < 0.05. RESULTS No group by time interaction was found for any variable. Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001). CONCLUSION Considering that both CS and TRT methods were equally effective to improve the physical fitness and functionality of elderly women, the decision of which protocol to use should be based on individual preferences and practical aspects.",2020,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001). ","['Participants (61.1\u202f±\u202f4.9\u202fyears, body mass 64.5\u202f±\u202f1.8\u202fkg, height 155.7\u202f±\u202f4.7\u202fcm', 'postmenopausal and elderly women', 'elderly women']","['traditional resistance training (TRT) or resistance training using Cluster-set (CS', 'CS', 'Cluster-sets resistance training', 'TRT']","['Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests', 'countermovement jump', '1 repetition maximum (RM) bench press', '1RM leg press', 'standing long jump', 'plank time', 'functional performance and physical fitness', 'squat jump']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",,0.024454,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001). ","[{'ForeName': 'Rayra Khalinka Neves', 'Initials': 'RKN', 'LastName': 'Dias', 'Affiliation': 'Faculty of Physical Education, Federal University of Pará, Castanhal, PA, Brazil.'}, {'ForeName': 'Eduardo Macedo', 'Initials': 'EM', 'LastName': 'Penna', 'Affiliation': 'Faculty of Physical Education, Federal University of Pará, Castanhal, PA, Brazil. Electronic address: eduardomp@ufpa.br.'}, {'ForeName': 'Adria Samara Negrão', 'Initials': 'ASN', 'LastName': 'Noronha', 'Affiliation': 'Faculty of Physical Education, Federal University of Pará, Castanhal, PA, Brazil.'}, {'ForeName': 'Antenor Barbosa Calandrini', 'Initials': 'ABC', 'LastName': 'de Azevedo', 'Affiliation': 'Faculty of Physical Education, Federal University of Pará, Castanhal, PA, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': 'Faculty of Physical Education and Dance, Federal University of Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Paulo Viana', 'Initials': 'PV', 'LastName': 'Gentil', 'Affiliation': 'Faculty of Physical Education and Dance, Federal University of Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Victor Silveira', 'Initials': 'VS', 'LastName': 'Coswig', 'Affiliation': 'Faculty of Physical Education, Federal University of Pará, Castanhal, PA, Brazil. Electronic address: vcoswig@gmail.com.'}]",Experimental gerontology,['10.1016/j.exger.2020.111011'] 3102,32592861,"Antidepressant Efficacy and Immune Effects of Bilateral Theta Burst Stimulation Monotherapy in Major Depression: A Randomized, Double-Blind, Sham-Controlled Study.",,2020,,['Major Depression'],['Bilateral Theta Burst Stimulation Monotherapy'],[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.446696,,"[{'ForeName': 'Po-Han', 'Initials': 'PH', 'LastName': 'Chou', 'Affiliation': 'Department of Psychiatry, China Medical University Hsinchu Hospital, China Medical University, Hsinchu, Taiwan; Department of Psychiatry, China Medical University Hospital, China Medical University, Taichung, Taiwan; Department of Biological Science and Technology, National Chiao Tung University, Hsinchu, Taiwan; Taiwan Allied Clinics for Integrative TMS, Taipei, Taiwan.'}, {'ForeName': 'Ming-Kuei', 'Initials': 'MK', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chon-Haw', 'Initials': 'CH', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Wan-Ting', 'Initials': 'WT', 'LastName': 'Hsieh', 'Affiliation': 'Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': 'Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Shityakov', 'Affiliation': 'College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': 'College of Medicine, China Medical University, Taichung, Taiwan; Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; An-Nan Hospital, China Medical University, Tainan, Taiwan. Electronic address: cobolsu@gmail.com.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.024'] 3103,32592897,IN-HOSPITAL MANAGEMENT OF SLEEP APNEA DURING HEART FAILURE HOSPITALIZATION- A RANDOMIZED CONTROLLED TRIAL.,"BACKGROUND Obstructive sleep apnea (OSA) is associated with increased mortality and readmissions in patients with heart failure (HF). The effect of in-hospital diagnosis and treatment of OSA during decompensated HF episodes remains unknown. METHODS A single site randomized controlled trial in hospitalized patients with decompensated HF (n=150) who were diagnosed with OSA during the hospitalization. All participants received guideline directed therapy for HF decompensation. Participants were randomized to an intervention arm which received positive airway pressure (PAP) therapy during the hospitalization (n=75) and a control arm (n=75). The primary outcome was discharge left ventricular ejection fraction (LVEF). RESULTS LVEF changed in the PAP arm from 25.5 (10.4) at baseline, to 27.3 (11.9) at discharge. In the control group, LVEF was 27.3 (11.7) at baseline and 28.8 (10.5) at conclusion. There was no significant effect on LVEF of in-hospital PAP compared to control (p = 0.84) in the intention to treat analysis. On treatment analysis in the intervention arm showed a significant increase in LVEF in participants who used PAP ≥ 3 hours per night (n=36, 48%) compared to those who used it less (p=0.01). There was a dose effect with higher hours of usage associated with more improvement in LVEF. Follow-up of readmissions after 6-months post discharge revealed a >60% decrease in readmissions for patients who used PAP ≥3 hours/night compared to those who used it less than 3 hours/night (p<0.02) and compared to controls (p<0.04). CONCLUSION In-hospital treatment with PAP was safe but did not significantly improve discharge LVEF in patients with decompensated HF and newly diagnosed OSA. Exploratory analysis showed that adequate use of PAP was associated with higher discharge LVEF and decreased 6 months readmissions.",2020,There was no significant effect on LVEF of in-hospital PAP compared to control (p = 0.84) in the intention to treat analysis.,"['hospitalized patients with decompensated HF (n=150) who were diagnosed with OSA during the hospitalization', 'patients with decompensated HF and newly diagnosed OSA', 'patients with heart failure (HF', 'Obstructive sleep apnea (OSA']","['positive airway pressure (PAP) therapy', 'LVEF', 'guideline directed therapy', 'OSA']","['LVEF', 'discharge LVEF', 'discharge left ventricular ejection fraction (LVEF', 'readmissions', 'LVEF of in-hospital PAP']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.0782909,There was no significant effect on LVEF of in-hospital PAP compared to control (p = 0.84) in the intention to treat analysis.,"[{'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Khayat', 'Affiliation': 'The UCI Sleep Disorders Center and the Division of Pulmonary and Critical Care, University of California at Irvine; The Sleep Heart Program at the Ohio State University. Electronic address: rnkhayat@gmail.com.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': 'Bethesda North Hospital, Cincinnati, OH; Division of Cardiovascular Medicine, The Ohio State University; University of Cincinnati College of Medicine.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Porter', 'Affiliation': 'The Center for Biostatistics, The Ohio State University.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sow', 'Affiliation': 'The Sleep Heart Program at the Ohio State University; The Center for Clinical and Translational Science, The Ohio State University.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Holt', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Randerath', 'Affiliation': 'Bethanien Hospital, Institute of Pneumology at the University of Cologne, Solingen, Germany.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jarjoura', 'Affiliation': 'The Sleep Heart Program at the Ohio State University; Division of Cardiovascular Medicine, The Ohio State University; The Center for Biostatistics, The Ohio State University.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.06.007'] 3104,32593046,"An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis.","Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis. METHODS 292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA: reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), ""therapeutic benefit"" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants. RESULTS The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a ""therapeutic benefit"" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs. CONCLUSION The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant ""therapeutic benefit"" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.",2020,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"['children, aged 6 to 11\u202fyears with acute viral and post-viral rhinosinusitis', '292 children aged 6 to 11\u202fyears with ARS', 'children with acute rhinosinusitis', 'Acute rhinosinusitis (ARS', 'patients with acute rhinosinusitis', 'acute rhinosinusitis in children aged 6 to 11\u202fyears']",['5 plant - extract BNO'],"['efficacy, safety and tolerability', ""patient's self-scoring of rhinorrhea"", 'severity of rhinorrhea, nasal congestion and post-nasal drip']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032081', 'cui_str': 'Plant extract'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}]",292.0,0.0255448,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"[{'ForeName': 'Vasyl I', 'Initials': 'VI', 'LastName': 'Popovych', 'Affiliation': 'ENT - Department of Ivano-Frankivsk National Medical University, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine. Electronic address: popovych_ent@ukr.net.'}, {'ForeName': 'Halyna V', 'Initials': 'HV', 'LastName': 'Beketova', 'Affiliation': 'Department of Children and Adolescent Diseases of the National Academy of Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}, {'ForeName': 'Ivana V', 'Initials': 'IV', 'LastName': 'Koshel', 'Affiliation': 'Department of Therapy and Family Medicine of Institute of Postgraduate Education of Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine.'}, {'ForeName': 'Olha A', 'Initials': 'OA', 'LastName': 'Tsodikova', 'Affiliation': 'Department of Outpatient Pediatrics KhMAPE, 58 Amosova Street, Kharkiv, Kharkiv Region 61176, Ukraine.'}, {'ForeName': 'Tetiana A', 'Initials': 'TA', 'LastName': 'Kriuchko', 'Affiliation': 'Department of Pediatrics №2 of Ukrainian Dental Academy, European Street, 39, Poltava, Poltava Region 36011, Ukraine.'}, {'ForeName': 'Aleksandr E', 'Initials': 'AE', 'LastName': 'Abaturov', 'Affiliation': 'Department of Pediatrics and Medical Genetics of Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Liudmyla I', 'Initials': 'LI', 'LastName': 'Vakulenko', 'Affiliation': 'Department of Pediatrics No. 2, Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Iurii V', 'Initials': 'IV', 'LastName': 'Gavrylenko', 'Affiliation': 'Department of Pediatric Otolaryngology of the National Academy of the Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102564'] 3105,32593069,Affective responses to climbing exercises in children and adolescents during in-patient treatment for mental health disorders a pilot study on acute effects of different exercise interventions.,"The aim of the present study was to compare acute effects of a climbing intervention (CI) on affective responses with a different exercise intervention (swimming, SI) and an occupational therapy intervention (OTI) in children and adolescents during in-patient treatment for mental health disorders. The following study was designed as a cross-over study. Participants completed three single 60 min interventions of CI, SI and OTI. Affective responses were assessed pre and post intervention and at 20 and 40 min during intervention. The sample consisted of 33 children and adolescents in mental-health inpatient care (ᴓage: 13.3 ± 2.2 years, ♀=39.4%). A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144. Repeated measures ANOVAs revealed a significant time by intervention effect for affective valence (p=.011, eta²=0.09), but not for perceived activation, favouring CI over SI and OCT between pre-test and the first 20 or 40 min, respectively. All interventions showed similar effects on affective responses pre to post interventions. CI seems to increase affective valence more strongly during intervention compared to SI and OTI. The present results may have implications for therapy adherence and acute emotion regulation in children and adolescent in-patients with mental health disorders.",2020,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","['children and adolescent in-patients with mental health disorders', '33 children and adolescents in mental-health inpatient care (ᴓage: 13.3\xa0±\xa02.2 years, ♀=39.4', 'children and adolescents during in-patient treatment for mental health disorders']","['exercise intervention (swimming, SI) and an occupational therapy intervention (OTI', 'exercise interventions', 'climbing exercises', 'climbing intervention (CI']","['perceived activation, favouring CI over SI and OCT', 'affective valence', 'Affective responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",33.0,0.0311106,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Frühauf', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria. Electronic address: anika.fruehauf@uibk.ac.at.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Sevecke', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Haid-Stecher', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Albertini', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Richter', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schipflinger', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}]",Psychiatry research,['10.1016/j.psychres.2020.113245'] 3106,32593123,Quality of life changes in response to yoga therapy in patients with schizophrenia: Reanalysis of Three randomized controlled trials.,,2020,,['patients with schizophrenia'],['yoga therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.0595902,,"[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Ikai-Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, M5S 2W6, Toronto, ON, Canada. Electronic address: sako0609@gmail.com.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Kimel Family Translational Imaging-Genetics Laboratory, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Geriatric Mental Health Program, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102250'] 3107,32593154,Alpha-tACS effect on inhibitory control and feasibility of administration in community outpatient substance use treatment.,"BACKGROUND Deficits in inhibitory control (IC) and distress tolerance (DT) are associated with substance use disorders (SUD) and post-treatment return to substance use. Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT. The aims of the current study were to examine the feasibility and acceptability of administering tACS in a community-based SUD treatment setting, and to test the effect of alpha-tACS on IC and DT. METHOD A double-blind, randomized, active sham-controlled trial of treatment-seeking adults with a SUD (N = 30, Mean age = 43.2 years, 70.0% male). Participants attended two sessions and completed computerized inhibitory control and distress tolerance tasks while receiving tACS targeting the bilateral dorsolateral prefrontal cortex (DLPFC). Participants received sham-tACS and were then randomized to receive sham-, alpha-, or gamma-tACS within 2-3 days. RESULTS Treatment retention was 87%. Participant self-reported belief of having received tACS and mean side effect intensity ratings did not differ across conditions, with all side effect ratings in the absent to mild range. There was a large (d = 0.83) and significant effect of alpha-tACS on inhibitory control compared to sham-tACS (β = 1.78, SE = 0.65, 95 % CI: 0.41, 3.14, p<0.01). There were no significant effects of condition on distress tolerance. CONCLUSIONS To our knowledge, this is the first study of tACS in adults with a SUD. Our findings provide preliminary evidence for recruitment, retention, and administration feasibility of tACS in a community-based substance use treatment program and a beneficial effect of alpha-tACS on inhibitory control.",2020,Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT.,"['treatment-seeking adults with a SUD (N = 30, Mean age = 43.2 years, 70.0% male', 'adults with a SUD']","['Transcranial alternating current stimulation (tACS', 'sham-, alpha-, or gamma-tACS', 'alpha-tACS', 'tACS', 'sham-tACS', 'computerized inhibitory control and distress tolerance tasks while receiving tACS']","['feasibility and acceptability', 'distress tolerance']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.0861259,Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT.,"[{'ForeName': 'Stacey B', 'Initials': 'SB', 'LastName': 'Daughters', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA. Electronic address: daughter@unc.edu.'}, {'ForeName': 'Jennifer Y', 'Initials': 'JY', 'LastName': 'Yi', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Carelli', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108132'] 3108,32593173,Pharmacodynamic studies of nasal tetracosactide with salivary glucocorticoids for a noninvasive Short Synacthen Test.,"CONTEXT The Short Synacthen Test (SST) is the gold standard for diagnosing adrenal insufficiency. It requires invasive administration of Synacthen, venous sampling, and is resource-intensive. OBJECTIVE To develop a nasally administered SST, with salivary glucocorticoids measurement, to assess the adrenal response. DESIGN We conducted 5 studies: 4 open-label, sequence-randomized, crossover, pharmacodynamic studies testing 6 doses/formulations and a repeatability study. Additionally, pharmacokinetic analysis was undertaken using our chosen formulation, 500 µg tetracosactide with mucoadhesive chitosan, Nasacthin003, in our pediatric study. SETTING Adult and children's clinical research facilities. PARTICIPANTS A total of 36 healthy adult males and 24 healthy children. INTERVENTION We administered all 6 nasal formulations using an European regulator endorsed atomization device. The IV comparators were 250 µg or 1 µg SST. MAIN OUTCOME MEASURES We analyzed paired blood and saliva samples for plasma cortisol and salivary cortisol and cortisone. RESULTS The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively). The bioavailability of Nasacthin003 was 14.3%. There was no significant difference in plasma cortisol at 60 minutes between 500 µg Nasacthin003 and 250 µg IV Synacthen (P = 0.17). The repeatability coefficient at 60 minutes was 105 nmol/L for IV Synacthen and salivary cortisol and cortisone was 10.3 and 21.1 nmol/L, respectively. The glucocorticoid response in children was indistinguishable from that of adults. CONCLUSIONS Nasal administration of Nasacthin003 generates equivalent plasma cortisol values to the 250-µg IV SST and, with measurement at 60 minutes of salivary cortisol or cortisone, provides a noninvasive test for adrenal insufficiency.",2020,"The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively).","[""Adult and children's clinical research facilities"", 'A total of 36 healthy adult males and 24 healthy children']",['salivary glucocorticoids'],"['plasma cortisol and salivary cortisol and cortisone', 'bioavailability of Nasacthin003', 'plasma cortisol values', 'peak cortisol response', 'repeatability coefficient', 'plasma cortisol', 'glucocorticoid response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]",36.0,0.0457079,"The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively).","[{'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Elder', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Vilela', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Trevor N', 'Initials': 'TN', 'LastName': 'Johnson', 'Affiliation': 'Certara UK Limited, Sheffield, United Kingdom.'}, {'ForeName': 'Rosie N', 'Initials': 'RN', 'LastName': 'Taylor', 'Affiliation': 'Statistical Services Unit, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'E Helen', 'Initials': 'EH', 'LastName': 'Kemp', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Keevil', 'Affiliation': 'Department of Clinical Biology, Manchester University NHS Trust, Manchester, United Kingdom.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Cross', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ross', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Wright', 'Affiliation': ""Department of Endocrinology, Sheffield Children's NHS Foundation Trust, Sheffield, United Kingdom.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa323'] 3109,32502040,"The research of Tuna Huichun Gong on pulmonary function, exercise tolerance, and quality of life in patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation.","INTRODUCTION Chronic obstructive pulmonary disease (COPD) is a common high-burden and highly disabling lung disease. The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles. Although recommended by the global initiative for chronic obstructive lung disease guidelines, pulmonary rehabilitation (PR) has not been used widely because of its inherent limitations. Tuna-Hui-Chun-Gong (TNHCG) is a popular traditional exercise used to treat COPD in China. We aim to evaluate the safety and efficacy of TNHCG for PR of COPD. METHODS The provided protocol is for a single-blind randomized controlled trial in which 120 COPD patients will be randomly and equally divided into the experimental or control group. The control group will be treated with standard COPD drugs while the experimental group will perform TNHCG exercises apart from standard drug treatment. The duration of treatment will be 24 weeks and a follow-up for 48 weeks. The primary outcome will be the 6-Minute Walk Test. The secondary outcomes will include the pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency. A safety assessment will also be performed during the trial. DISCUSSION Our study will provide evidence to support TNHCG exercise as an additional measure for PR of COPD. TRIAL REGISTRATION ChiCTR1900028332, Registered December 29, 2019. ETHICS AND DISSEMINATION Ethics approval has been granted by the Sichuan Traditional Chinese Medicine Regional Ethics Review Committee (No. 2019KL-050).",2020,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"['Chronic obstructive pulmonary disease (COPD', '120 COPD patients', 'patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation', 'patients with COPD', 'Registered December 29, 2019']","['Tuna Huichun Gong', 'Tuna-Hui-Chun-Gong (TNHCG', 'TNHCG', 'TNHCG exercise', 'standard COPD drugs while the experimental group will perform TNHCG exercises']","['pulmonary function, exercise tolerance, and quality of life', '6-Minute Walk Test', 'quality of life and exercise endurance', 'safety and efficacy', ""pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency""]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0041382', 'cui_str': 'Tuna'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",120.0,0.106714,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Su', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianming', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Respiratory Medicine, AVIC 363 Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020625'] 3110,32198802,A Phase 2a Trial Investigating the Safety and Tolerability of the Novel Cortical Enhancer IRL752 in Parkinson's Disease Dementia.,"BACKGROUND IRL752 is a novel small-molecule compound that acts to regioselectively enhance norepinephrine, dopamine, and acetylcholine neurotransmission in the cerebral cortex. OBJECTIVE The primary objective of the trial was to investigate the safety and tolerability of IRL752 in patients with Parkinson's disease and dementia. METHODS Patients with Parkinson's disease and dementia were randomized to IRL752 or placebo treatment (3:1 ratio) for 28 days. The study drug was given as an adjunct treatment to the patients' regular stable antiparkinsonian medication. Dosing was individually titrated for 14 days after which the dose was kept stable for an additional 14 days. RESULTS A total of 32 patients were randomized to treatment, and 29 patients completed the 4-week treatment. Adverse events were generally mild and transient and were mostly reported during the dose titration phase. There were 2 serious adverse events, and none of them were related to the experimental treatment. The average dose achieved in the stable dose phase was 600 mg daily, yielding a 2-hour postdose plasma concentration of about 4 μM on day 28. Exploratory assessment of secondary outcomes indicated efficacy for symptoms and signs known to be poorly responsive to levodopa. CONCLUSIONS IRL752 appears to be safe and well tolerated for a 4-week treatment in patients with Parkinson's disease and dementia. © 2020 International Parkinson and Movement Disorder Society.",2020,"There were 2 serious adverse events, and none of them were related to the experimental treatment.","[""Parkinson's Disease Dementia"", ""patients with Parkinson's disease and dementia"", ""patients' regular stable antiparkinsonian medication"", ""Patients with Parkinson's disease and dementia"", '32 patients']","['Novel Cortical Enhancer IRL752', 'IRL752', 'IRL752 or placebo']","['Adverse events', 'safety and tolerability', 'Safety and Tolerability', 'serious adverse events', 'safe and well tolerated']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0003405', 'cui_str': 'Antiparkinsonians'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",32.0,0.0512868,"There were 2 serious adverse events, and none of them were related to the experimental treatment.","[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Odin', 'Affiliation': 'Division of Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Nil', 'Initials': 'N', 'LastName': 'Dizdar', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Johansson', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Grigoriou', 'Affiliation': 'Division of Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Tsitsi', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Klas', 'Initials': 'K', 'LastName': 'Wictorin', 'Affiliation': 'Department of Neurology, Helsingborg Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Bergquist', 'Affiliation': 'Department of Pharmacology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Nyholm', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Rinne', 'Affiliation': 'Clinical Research Services Turku Oy, Turku, Finland.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Hansson', 'Affiliation': 'Clinical Trial Consultants, Uppsala, Sweden.'}, {'ForeName': 'Clas', 'Initials': 'C', 'LastName': 'Sonesson', 'Affiliation': 'Integrative Research Laboratories AB, Göteborg, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Tedroff', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28020'] 3111,29564732,Validation of the oxygen desaturation index in the diagnostic workup of obstructive sleep apnea.,"INTRODUCTION Obstructive sleep apnea (OSA) is common, and diagnosis requires expensive and laborious testing to assess the apnea hypopnea index (AHI). We performed an analysis to explore the relationship between the oxygen desaturation index (ODI) as measured with pulse oximetry and the AHI in our large portable monitoring (PM) database to find an optimal cutoff value for the ODI in order to be able to exclude AHI ≥ 5 on PM. METHODS Three thousand four hundred thirteen PM recordings were randomly divided into a training set (N = 2281) and a test set (N = 1132). The optimal cutoff for the ODI to exclude an AHI ≥ 5 on PM was determined in the training set and subsequently validated in the test set. RESULTS Area under the curve of the ODI to exclude an AHI ≥ 5 on PM was 0.997 in the training set and 0.996 in the test set. In the training set, the optimal cutoff to predict an AHI < 5 was an ODI < 5. Using this cutoff in the test set provided a sensitivity of 97.7%, a specificity of 97.0%, a positive predictive value of 99.2%, and a negative predictive value of 91.4%. CONCLUSION An ODI < 5 predicts an AHI < 5 with high sensitivity and specificity when measured simultaneously using the same oximeter during PM recording.",2019,"Using this cutoff in the test set provided a sensitivity of 97.7%, a specificity of 97.0%, a positive predictive value of 99.2%, and a negative predictive value of 91.4%. ","['Three thousand four hundred thirteen PM recordings', 'obstructive sleep apnea']",[],"['apnea hypopnea index (AHI', 'oxygen desaturation index (ODI']","[{'cui': 'C4517731', 'cui_str': 'Three thousand four hundred'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",[],"[{'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0153202,"Using this cutoff in the test set provided a sensitivity of 97.7%, a specificity of 97.0%, a positive predictive value of 99.2%, and a negative predictive value of 91.4%. ","[{'ForeName': 'Timon M', 'Initials': 'TM', 'LastName': 'Fabius', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands. T.Fabius@mst.nl.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Benistant', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Bekkedam', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Frans H C', 'Initials': 'FHC', 'LastName': 'de Jongh', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}, {'ForeName': 'Michiel M M', 'Initials': 'MMM', 'LastName': 'Eijsvogel', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Onderzoeksbureau Longgeneeskunde, P.O. Box 50000, 7500 KA, Enschede, the Netherlands.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1654-2'] 3112,31710522,Aerobic Exercise Induces Cardiac Fat Loss and Alters Cardiac Muscle Mass Through an Interleukin-6 Receptor-Dependent Mechanism: Cardiac Analysis of a Double-Blind Randomized Controlled Clinical Trial in Abdominally Obese Humans.,,2019,,['Abdominally Obese Humans'],['Aerobic Exercise'],['Cardiac Fat Loss and Alters Cardiac Muscle Mass'],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.677863,,"[{'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Louise Lang', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Grit Elster', 'Initials': 'GE', 'LastName': 'Legaard', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Bente Klarlund', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Jaya Birgitte', 'Initials': 'JB', 'LastName': 'Rosenmeier', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Bispebjerg, Denmark (J.B.R.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042287'] 3113,32067251,Randomized Controlled Trial of a Multilevel Intervention to Address Social Determinants of Refugee Mental Health.,"Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential. Growing evidence documents post-migration stressors related to marginalization as key social determinants of refugee mental health. The goal of this RCT was to rigorously test a social justice approach to reducing high rates of distress among refugees in the United States. The 6-month multilevel, strengths-based Refugee Well-being Project (RWP) intervention brought together university students enrolled in a 2-semester course and recently resettled refugees to engage in mutual learning and collaborative efforts to mobilize community resources and improve community and systems responsiveness to refugees. Data collected from 290 Afghan, Great Lakes African, Iraqi, and Syrian refugees at four time points over 12 months were used to test the effectiveness of RWP to reduce distress (depression and anxiety symptoms) and increase protective factors (English proficiency, social support, connection to home and American cultures). Intention-to-treat analyses using multilevel modeling revealed significant intervention effects for all hypothesized outcomes. Results provide evidence to support social justice approaches to improving refugee mental health. Findings have implications for refugees worldwide, and for other immigrant and marginalized populations who experience inequities in resources and disproportionate exposure to trauma/stress.",2020,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,[],"['RWP', 'strengths-based Refugee Well-being Project (RWP) intervention', 'Multilevel Intervention']","['protective factors (English proficiency, social support, connection to home and American cultures', 'distress (depression and anxiety symptoms']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0037438'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0395065,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,"[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Goodkind', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bybee', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Julia Meredith', 'Initials': 'JM', 'LastName': 'Hess', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Suha', 'Initials': 'S', 'LastName': 'Amer', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ndayisenga', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Greene', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Ryeora', 'Initials': 'R', 'LastName': 'Choe', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Isakson', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Baca', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mahbooba', 'Initials': 'M', 'LastName': 'Pannah', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}]",American journal of community psychology,['10.1002/ajcp.12418'] 3114,31539072,Effect of the iExaminer Teaching Method on Fundus Examination Skills: A Randomized Clinical Trial.,,2019,,[],['iExaminer Teaching Method'],['Fundus Examination Skills'],[],"[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]",,0.106213,,"[{'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Shikino', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kikukawa', 'Affiliation': 'Department of Medical Education, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masatomi', 'Initials': 'M', 'LastName': 'Ikusaka', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11891'] 3115,31772117,Ottawa Statement does not impede randomised evaluation of government health programmes.,"In this issue of JME , Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committees (RECs), Watson et al argue that the health programme per se is not within the researcher's control or responsibility and, thus, is out of scope for ethics review. We argue that this view is wrong. The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants. And the randomised evaluation of health programmes impacts the liberty and welfare interests of participants insofar as they may be exposed to a harmful programme or denied access to a beneficial one. Further, Watson et al 's claim that 'study programmes … would occur whether or not there were any … research activities' is incorrect in the case of cluster randomised designs. In a cluster randomised trial, the government does not implement a programme as usual. Rather, researchers collaborate with the government to randomise clusters to intervention or control conditions in order to rigorously evaluate the programme. As a result, equipoise issues are triggered that must be addressed by the REC.",2020,"The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants.",[],[],[],[],[],[],,0.0888451,"The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants.","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Weijer', 'Affiliation': 'Rotman Institute of Philosophy, Western University, London, Ontario, Canada cweijer@uwo.ca.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]",Journal of medical ethics,['10.1136/medethics-2019-105938'] 3116,31068405,Text Messages Can Encourage Patients to Discuss and Receive HIV Testing in Primary Care.,"OBJECTIVE Routine HIV testing is not adequately occurring in primary care. One reason is that physicians perceive that patients do not want to discuss HIV testing and would prefer that patients initiate the discussion. A patient-centered text message campaign may prompt patients to discuss HIV testing with their physicians, thereby increasing HIV testing. METHODS The study took place in clinics serving low-income populations. Participants received a randomized text message 30 minutes before their appointment, prompting them to discuss either HIV or an unrelated health topic with their physician. Participants were interviewed after their appointment to ascertain if they had discussed HIV testing, and test orders were verified via electronic medical record. RESULTS Among participants sent an HIV text message (n = 17), 6 were HIV tested (35%). No participants sent a control text message were HIV tested. Of the 10 participants who reported reading the HIV message, 7 (70%) discussed HIV with their physician and 6 (60%) were tested. CONCLUSION Our proof-of-concept study suggests an HIV text message campaign may increase HIV testing by encouraging patients to initiate discussion with their physicians. This intervention may increase HIV testing among low-income populations. A larger study is needed to confirm these findings.",2019,Our proof-of-concept study suggests an HIV text message campaign may increase HIV testing by encouraging patients to initiate discussion with their physicians.,"['clinics serving low-income populations', '10 participants who reported reading the HIV message, 7 (70%) discussed HIV with their physician and 6 (60%) were tested']",[],[],"[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0024045', 'cui_str': 'Low-Income Population'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",[],[],,0.0328989,Our proof-of-concept study suggests an HIV text message campaign may increase HIV testing by encouraging patients to initiate discussion with their physicians.,"[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Wettermann', 'Affiliation': 'From the School of Medicine, Baylor College of Medicine, Houston, TX (RW, HM); Department of Medicine, Baylor College of Medicine (TPG, MA); Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX (TPG, MA). wetterma@bcm.edu.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Marek', 'Affiliation': 'From the School of Medicine, Baylor College of Medicine, Houston, TX (RW, HM); Department of Medicine, Baylor College of Medicine (TPG, MA); Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX (TPG, MA).'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Giordano', 'Affiliation': 'From the School of Medicine, Baylor College of Medicine, Houston, TX (RW, HM); Department of Medicine, Baylor College of Medicine (TPG, MA); Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX (TPG, MA).'}, {'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Arya', 'Affiliation': 'From the School of Medicine, Baylor College of Medicine, Houston, TX (RW, HM); Department of Medicine, Baylor College of Medicine (TPG, MA); Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX (TPG, MA).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.03.180269'] 3117,31085424,Minimal but meaningful: Probing the limits of randomly assigned social identities.,"The current studies (total N = 151) experimentally manipulated meaningfulness in novel social groups and measured any resulting ingroup biases. Study 1 showed that even when groups were arbitrary and presumptively meaningless, 5- to 8-year-old children developed equally strong ingroup biases as children in more meaningful groups. Study 2 explored the lengths required to effectively reduce ingroup biases by stressing the arbitrariness of the grouping dimension. Even in this case, ingroup bias persisted in resource allocation behavior, although it was attenuated on preference and similarity measures. These results suggest that one needs to go to great lengths to counteract children's tendency to imbue newly encountered social groups with rich affiliative meaning.",2019,"Even in this case, ingroup bias persisted in resource allocation behavior, although it was attenuated on preference and similarity measures.",[],[],[],[],[],[],151.0,0.0113727,"Even in this case, ingroup bias persisted in resource allocation behavior, although it was attenuated on preference and similarity measures.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Yale University, New Haven, CT 06511, USA. Electronic address: xin.yang@yale.edu.'}, {'ForeName': 'Yarrow', 'Initials': 'Y', 'LastName': 'Dunham', 'Affiliation': 'Department of Psychology, Yale University, New Haven, CT 06511, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.04.013'] 3118,31543515,"Comment on ""Hyaluronic acid injection in glans penis for treatment of premature ejaculation: a randomized controlled cross-over study"".",,2020,,['premature ejaculation'],['Hyaluronic acid injection'],[],"[{'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",[],,0.0438367,,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Gul', 'Affiliation': 'Department of Urology, Aksaray University School of Medicine, Aksaray, Turkey. drmuratgul@hotmail.com.'}]",International journal of impotence research,['10.1038/s41443-019-0200-5'] 3119,32085932,"In Regard to Fernando et al.: Synchronous versus sequential chemo-radiotherapy in patients with early stage breast cancer (SECRAB): A randomised, phase III, trial.",,2020,,['patients with early stage breast cancer (SECRAB'],['sequential chemo-radiotherapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0267288,,"[{'ForeName': 'Melis', 'Initials': 'M', 'LastName': 'Gultekin', 'Affiliation': 'Hacettepe University, Faculty of Medicine, Department of Radiation Oncology, Turkey. Electronic address: melisgultekin@hacettepe.edu.tr.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Tilki', 'Affiliation': 'Hacettepe University, Faculty of Medicine, Department of Radiation Oncology, Turkey.'}, {'ForeName': 'Ferah', 'Initials': 'F', 'LastName': 'Yildiz', 'Affiliation': 'Hacettepe University, Faculty of Medicine, Department of Radiation Oncology, Turkey.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.01.015'] 3120,32194254,Commentary on 'Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to eight weeks later: A randomized controlled trial' (Int J Surg 2020;76:37-44).,,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.137515,,"[{'ForeName': 'Meer M', 'Initials': 'MM', 'LastName': 'Chisthi', 'Affiliation': 'Department of General Surgery, Government Medical College, Trivandrum, Kerala, 695011, India. Electronic address: meerchisthi@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.015'] 3121,31987974,Derivation of Dose/Volume Constraints for the Anorectum from Clinician- and Patient-Reported Outcomes in the CHHiP Trial of Radiation Therapy Fractionation.,"PURPOSE The CHHiP trial randomized 3216 men with localized prostate cancer (1:1:1) to 3 radiation therapy fractionation schedules: 74 Gy in 37 fractions over 7.4 weeks; 60 Gy in 20 fractions over 4 weeks; and 57 Gy in 19 fractions over 3.8 weeks. Literature-based dose constraints were applied with arithmetic adjustment for the hypofractionated arms. This study aimed to derive anorectal dose constraints using prospectively collected clinician-reported outcomes (CROs) and patient-reported outcomes (PROs) and to assess the added predictive value of spatial dose metrics. METHODS AND MATERIALS A case-control study design was used; 7 CRO and 5 PRO bowel symptoms were evaluated. Cases experienced a moderate or worse symptom 1 to 5 years after-radiation therapy and did not have the symptom before radiation therapy. Controls did not experience the symptom at baseline or between 1 to 5 years after radiation therapy. The anorectum was recontoured from the anal verge to the rectosigmoid junction; dose/volume parameters were extracted. Univariate logistic regression, atlases of complication indices, and bootstrapped receiver-operating-characteristic analysis (1000 replicates, balanced outcomes) were used to derive dose constraints for the whole cohort (hypofractionated schedules were converted to 2-Gy equivalent schedules using α/β = 3 Gy) and separate hypofractionated/conventional fractionation cohorts. Only areas under the curve with 95% confidence interval lower limits >0.5 were considered statistically significant. Any constraint derived in <95% to 99% of bootstraps was excluded. RESULTS Statistically significant dose constraints were derived for CROs but not PROs. Intermediate to high doses were important for rectal bleeding, whereas intermediate doses were important for increased bowel frequency, fecal incontinence, and rectal pain. Spatial dose metrics did not improve prediction of CROs or PROs. A new panel of dose constraints for hypofractionated schedules to 60 Gy or 57 Gy are V20Gy <85%, V30Gy <57%, V40Gy <38%, V50Gy <22%, and V60Gy <0.01%. CONCLUSIONS Dose constraints differed among symptoms, indicating potentially different pathogenesis of radiation-induced side effects. Derived dose constraints were stricter than those used in CHHiP and may reduce bowel symptoms after radiation therapy.",2020,"Intermediate to high doses were important for rectal bleeding whereas intermediate doses were important for increased bowel frequency, faecal incontinence and rectal pain.",['3216 men with localised prostate cancer (1:1:1'],[],"['bowel frequency, faecal incontinence and rectal pain', 'prediction of CRO or PRO']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0034886', 'cui_str': 'Rectal pain (finding)'}]",3216.0,0.0516445,"Intermediate to high doses were important for rectal bleeding whereas intermediate doses were important for increased bowel frequency, faecal incontinence and rectal pain.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilkins', 'Affiliation': 'Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom; The Royal Marsden Hospital, London, United Kingdom. Electronic address: anna.wilkins@icr.ac.uk.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom; Radiotherapy Trials Quality Assurance Group, London, United Kingdom.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Brand', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom; Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Fernandez', 'Affiliation': 'Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dearnaley', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom; Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gulliford', 'Affiliation': 'Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.003'] 3122,32049681,Is Needle Knife Fistulotomy a Shortcut to Preventing Postendoscopic Retrograde Pancreatitis?,"Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) remains a common and potentially severe adverse event, with continued research efforts to reduce PEP incidence. Robust evidence exists supporting the selective use of pancreatic duct stent placement, administration of rectal indomethacin, wire-guided cannulation technique, and aggressive fluid hydration using lactated Ringer solution. Jang et al. presented a randomized control trial describing primary needle-knife fistulotomy and its benefit for biliary access and reduced PEP incidence. Although these data are compelling, we discuss the key study limitations and the need for further studying the role of primary needle-knife fistulotomy.",2020,"Robust evidence exists supporting the selective use of pancreatic duct stent placement, administration of rectal indomethacin, wire-guided cannulation technique, and aggressive fluid hydration using lactated Ringer solution.",[],"['endoscopic retrograde cholangiopancreatography pancreatitis (PEP', 'lactated Ringer solution', 'rectal indomethacin']",[],[],"[{'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}]",[],,0.0301027,"Robust evidence exists supporting the selective use of pancreatic duct stent placement, administration of rectal indomethacin, wire-guided cannulation technique, and aggressive fluid hydration using lactated Ringer solution.","[{'ForeName': 'Dennis Di', 'Initials': 'DD', 'LastName': 'Chen', 'Affiliation': 'Northwestern Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Rajesh N', 'Initials': 'RN', 'LastName': 'Keswani', 'Affiliation': 'Northwestern Medicine, Chicago, Illinois, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000553'] 3123,31974920,Effect of adjunctive tobramycin inhalation versus placebo on early clinical response in the treatment of ventilator-associated pneumonia: the VAPORISE randomized-controlled trial.,,2020,,['ventilator-associated pneumonia'],['adjunctive tobramycin inhalation versus placebo'],[],"[{'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.218743,,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Stokker', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Karami', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Hoek', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Gommers', 'Affiliation': 'Department of Intensive Care, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'van der Eerden', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, The Netherlands. m.vandereerden@erasmusmc.nl.'}]",Intensive care medicine,['10.1007/s00134-019-05914-5'] 3124,31610383,Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R).,"OBJECTIVES To develop an age-based norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R). METHODS In sum, 33,835 submissions (data sample 1) of the expanded and revised BISQ-R by caregivers of infants and toddlers (1-36 months) were analyzed in the US via a publicly-available smartphone application, Johnson's® Bedtime®. Three subscales were created: Infant Sleep (IS; 5 items), Parent Perception (PP; 3 items), and Parent Behavior (PB; 11 items). The scoring algorithm was based on an age-based normative system, and each subscale was scored using a weighted average of items. Primary application of the scoring model was performed on a follow up set of 16,531 submissions (data sample 2). Secondary application was tested on an original web-based ecology study (data sample 3). Tertiary application was tested using previously published datasets consisting of a longitudinal study (data sample 4) and randomized control trial behavioral intervention study (data sample 5). RESULTS Overall application of the scoring algorithm was confirmed across multiple samples. Each subscale (IS, PP, PB) and total score (T) is age referenced (scores range from 0 to 100). Cross-comparison between subscales across studies reveal consistent and convergent relationships. CONCLUSIONS The BISQ-R provides a comprehensive assessment of infant and toddler sleep patterns, as well as parent perception and parent behaviors that may contribute to sleep outcomes. The age-based norm-referenced scoring system is publicly available to be used by researchers and clinicians.",2019,"The BISQ-R provides a comprehensive assessment of infant and toddler sleep patterns, as well as parent perception and parent behaviors that may contribute to sleep outcomes.",[],[],"['Brief Infant Sleep Questionnaire - Revised (BISQ-R', 'Each subscale (IS, PP, PB) and total score (T']",[],[],"[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0305894,"The BISQ-R provides a comprehensive assessment of infant and toddler sleep patterns, as well as parent perception and parent behaviors that may contribute to sleep outcomes.","[{'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Mindell', 'Affiliation': ""Psychology, Saint Joseph's University, Philadelphia, PA, USA; Sleep Center, Children's Hospital of Philadelphia, Philadelphia, PA, USA. Electronic address: jmindell@sju.edu.""}, {'ForeName': 'Russell A', 'Initials': 'RA', 'LastName': 'Gould', 'Affiliation': 'Johnson & Johnson Consumer Inc., Skillman, NJ, USA.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Tikotzy', 'Affiliation': 'Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Leichman', 'Affiliation': ""Psychology, Saint Joseph's University, Philadelphia, PA, USA.""}, {'ForeName': 'Russel M', 'Initials': 'RM', 'LastName': 'Walters', 'Affiliation': 'Johnson & Johnson Consumer Inc., Skillman, NJ, USA.'}]",Sleep medicine,['10.1016/j.sleep.2019.05.010'] 3125,31777325,"Patient Engagement Survey Regarding Future Double-Blinded, Randomized Controlled Trial of Tapering of Chronic Opioid Therapy.","Objective: There is a lack of evidence regarding tapering opioid medications in patients with chronic non-cancer pain. The purpose of this survey was to gather perspectives on future research into opioid tapering from utilizers of chronic opioid therapy (COT) or other people affected by chronic noncancer pain. Methods: The survey was distributed in paper form to patients on COT and via an online platform to patients self-enrolled in the chronic pain patient engagement group. The survey included a layman's description of a possible tapering trial of opioid medications and elicited binary responses regarding willingness to participate and reasoning as well as qualitative freeform responses. Thematic analysis was performed to identify themes in narrative responses. Results: A total of 190 surveys were returned with 72.1% of all respondents answering positively regarding their willingness to participate in a proposed study. The most common reasons for participating in the study included concerns regarding opioid dependence, adding to society's knowledge of opioid medications, and determining if the respondent would personally receive benefit from opioid medications. Patients recently on COT felt it was important to be able to withdraw from the study and return to usual care at any time (41.8% for recent COT and 15.5% for no recent COT, P < .05). The most common reason for unwillingness to participate was that respondents did not feel they had enough information to feel comfortable participating. The narrative responses showed a group of respondents felt COT was the only answer to their or their loved ones' chronic pain and that a study would demonstrate the need to continue these medications long-term. There were also stories of side effects and dependence with decreasing effectiveness of opioids for pain control. When prompted to comment on study design, respondents indicated the study should include alternative pain management options. This was accompanied by responses with the assumption that pain will worsen as opioid medications are decreased. Conclusion: Patient concerns regarding opioid medications and discontinuation reflect the lack of evidence available to prescribers. There appears to be patient support for future research into the effects of tapering opioid medications.",2019,A total of 190 surveys were returned with 72.1% of all respondents answering positively regarding their willingness to participate in a proposed study.,"['to patients self-enrolled in the chronic pain patient engagement group', 'patients with chronic non-cancer pain']","['chronic opioid therapy (COT', 'Chronic Opioid Therapy', 'COT and via an online platform']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],190.0,0.0553022,A total of 190 surveys were returned with 72.1% of all respondents answering positively regarding their willingness to participate in a proposed study.,"[{'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'James', 'Affiliation': 'Mayo Clinic, Eau Claire, WI, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': 'Witt', 'Affiliation': 'Mayo Clinic, Eau Claire, WI, USA.'}]",Journal of primary care & community health,['10.1177/2150132719890231'] 3126,31840339,Can linguistic analysis be used to identify whether adolescents with a chronic illness are depressed?,"Comorbid depression is common in adolescents with chronic illness. We aimed to design and test a linguistic coding scheme for identifying depression in adolescents with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), by exploring features of e-consultations within online cognitive behavioural therapy treatment. E-consultations of 16 adolescents (aged 11-17) receiving FITNET-NHS (Fatigue in teenagers on the interNET in the National Health Service) treatment in a national randomized controlled trial were examined. A theoretically driven linguistic coding scheme was developed and used to categorize comorbid depression in e-consultations using computerized content analysis. Linguistic coding scheme categorization was subsequently compared with classification of depression using the Revised Children's Anxiety and Depression Scale published cut-offs (t-scores ≥65, ≥70). Extra linguistic elements identified deductively and inductively were compared with self-reported depressive symptoms after unblinding. The linguistic coding scheme categorized three (19%) of our sample consistently with self-report assessment. Of all 12 identified linguistic features, differences in language use by categorization of self-report assessment were found for ""past focus"" words (mean rank frequencies: 1.50 for no depression, 5.50 for possible depression, and 10.70 for probable depression; p < .05) and ""discrepancy"" words (mean rank frequencies: 16.00 for no depression, 11.20 for possible depression, and 6.40 for probable depression; p < .05). The linguistic coding profile developed as a potential tool to support clinicians in identifying comorbid depression in e-consultations showed poor value in this sample of adolescents with CFS/ME. Some promising linguistic features were identified, warranting further research with larger samples.",2020,The linguistic coding profile developed as a potential tool to support clinicians in identifying comorbid depression in e-consultations showed poor value in this sample of adolescents with CFS/ME.,"['adolescents with chronic illness', '16 adolescents (aged 11 - 17) receiving', 'adolescents with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME']","['linguistic coding scheme', 'FITNET-NHS treatment']",['language use by categorisation of self-report assessment'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015674', 'cui_str': 'Systemic Exertion Intolerance Disease'}]","[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",16.0,0.0473073,The linguistic coding profile developed as a potential tool to support clinicians in identifying comorbid depression in e-consultations showed poor value in this sample of adolescents with CFS/ME.,"[{'ForeName': 'Lauren Stephanie', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Loades', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Barnes', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Crawley', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2417'] 3127,31931509,The acute effects of nicotine on corticostriatal responses to distinct phases of reward processing.,"Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues. This anticipatory effect is selective as no clear evidence has emerged showing that nicotine acutely changes reward receipt reactivity. However, repeated rewarding experiences shift peak brain reactivity from hedonic reward outcome to the motivational anticipatory cue yielding more habitual cue-induced behavior. Given nicotine's influence on NAcc reactivity and connectivity, it is plausible that nicotine acutely induces this shift and alters NAcc functional connectivity during reward processing. To evaluate this currently untested hypothesis, a randomized crossover design was used in which healthy non-smokers were administered placebo and nicotine (2-mg lozenge). Brain activation to monetary reward anticipation and outcome was evaluated with functional magnetic resonance imaging. Relative to placebo, nicotine induced more NAcc reactivity to reward anticipation. Greater NAcc activation during anticipation was significantly associated with lower NAcc activation to outcome. During outcome, nicotine reduced NAcc functional connectivity with cortical regions including the anterior cingulate cortex, orbitofrontal cortex, and insula. These regions showed the same negative relationship between reward anticipation and outcome as noted in the NAcc. The current findings significantly improve our understanding of how nicotine changes corticostriatal circuit function and communication during distinct phases of reward processing and critically show that these alterations happen acutely following a single dose. The implications of this work explain nicotinic modulation of general reward function, which offer insights into the initial drive to smoke and the subsequent difficulty in cessation.",2020,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,['healthy non-smokers'],"['nicotine', 'Nicotine', 'placebo and nicotine (2-mg lozenge', 'placebo, nicotine']","['anterior cingulate cortex, orbitofrontal cortex, and insula', 'Greater NAcc activation', 'habitual cue-induced behavior']","[{'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0321595,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,"[{'ForeName': 'Kainan S', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zegel', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Molokotos', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Lauren V', 'Initials': 'LV', 'LastName': 'Moran', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Olson', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA. ajanes@mclean.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0611-5'] 3128,32128634,Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS.,"BACKGROUND In TAGS, an international, double-blind, phase 3 trial, trifluridine/tipiracil significantly improved overall survival and progression-free survival compared with placebo in heavily pretreated metastatic gastric cancer patients. This paper reports pre-specified quality of life (QoL) outcomes for TAGS. METHODS Patients were randomized 2:1 to trifluridine/tipiracil (35 mg/m 2 twice daily on days 1-5 and 8-12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC. QoL was evaluated at baseline and at each treatment cycle, using the EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaires; results were considered valid for analysis only if ≥ 10% of patients completed the questionnaires. Key QoL outcomes were mean changes from baseline and time to deterioration in QoL. A post hoc analysis assessed the association between QoL and time to deterioration of Eastern Cooperative Oncology Group performance score (ECOG PS) to ≥ 2. RESULTS Of 507 randomized patients, 496 had baseline QoL data available. The analysis cut-off was 6 cycles for trifluridine/tipiracil and 3 cycles for placebo. In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores. In a sensitivity analysis including death and disease progression as events, there was a trend towards trifluridine/tipiracil reducing the risk of deterioration of QoL scores compared with placebo. Deterioration in the GHS score was associated with deterioration in ECOG PS. CONCLUSION QoL was maintained in TAGS, and there was a trend towards trifluridine/tipiracil reducing the risk of QoL deterioration compared with placebo. Trial registration ClinicalTrials.gov number: NCT02500043.",2020,"In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores.","['heavily pretreated metastatic gastric cancer patients', 'Patients', 'Of 507 randomized patients, 496 had baseline QoL data available', 'heavily pretreated metastatic gastric cancer']","['placebo', 'trifluridine/tipiracil (35\xa0mg/m 2 twice daily on days 1-5 and 8-12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC', 'trifluridine/tipiracil']","['death and disease progression', 'QoL', 'risk of deterioration of QoL scores', 'overall survival and progression-free survival', 'mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores', 'pre-specified quality of life (QoL) outcomes']","[{'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}]",507.0,0.549219,"In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores.","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain. jtabernero@vhio.net.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain.""}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'Omsk Regional Clinical Centre of Oncology, Omsk, Russia.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Hendrik-Tobias', 'Initials': 'HT', 'LastName': 'Arkenau', 'Affiliation': 'Sarah Cannon Research Institute, London, UK.'}, {'ForeName': 'Aliaksandr', 'Initials': 'A', 'LastName': 'Prokharau', 'Affiliation': 'Minsk City Clinical Oncology Dispensary, Minsk, Belarus.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ghidini', 'Affiliation': 'Azienda Ospedaliera di Cremona, Cremona, Italy.'}, {'ForeName': 'Catia', 'Initials': 'C', 'LastName': 'Faustino', 'Affiliation': 'Instituto Português de Oncologia do Porto Francisco Gentil, Porto, Portugal.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Gorbunova', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'Alexandrov National Cancer Centre of Belarus, Minsk, Belarus.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': 'University of Toyama, Toyama, Japan.'}, {'ForeName': 'Şuayib', 'Initials': 'Ş', 'LastName': 'Yalçın', 'Affiliation': 'Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sabater', 'Affiliation': 'Market Access Department, Servier, Suresnes, France.'}, {'ForeName': 'Donia', 'Initials': 'D', 'LastName': 'Skanji', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Leger', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01053-9'] 3129,32234610,"Examining the associations between alcohol-related parental communication, alcohol use, and protective behavioral strategy use among young adults.","Underage alcohol use is a public health concern as it remains prevalent and problematic. Protective behavioral strategies (PBS) may prevent or reduce alcohol-related consequences, yet daily-level findings show they instead might be associated with increased drinking and consequences. While parents are a possible source of influence to their child's decision making, it is unclear whether parental communication about alcohol affects drinking outcomes, with mixed findings noted in the literature. Furthermore, little research focuses on understanding how parental communication may impact the use of PBS. This study assessed whether alcohol specific parental communication would be associated with reduced drinking and increased use of PBS. Data from baseline and 3-month follow up were evaluated from a control group of a larger randomized controlled trial on 18- to 20-year-olds in the U.S. (N = 269). Outcomes included drinks per week, peak drinks per occasion, negative consequences and use of PBS. Using negative binomial regression modeling, controlling for age, sex, and whether participants lived with parents, findings revealed that parental communication was not associated with drinks per week, peak drinks per occasion, or negative consequences reported 3 months later. However, it was positively associated with limiting/stopping drinking PBS, manner of drinking PBS, and serious harm reduction PBS reported 3 months later. Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking. Research is needed to determine why parental communication may influence the use of PBS and how we can strengthen the quality or focus of communication to ultimately increase the impact on risk behaviors.",2020,Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking.,"['18- to 20-year-olds in the U.S', 'young adults']",['Protective behavioral strategies (PBS'],"['drinks per week, peak drinks per occasion, negative consequences and use of PBS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}]",,0.0247036,Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking.,"[{'ForeName': 'Dana M', 'Initials': 'DM', 'LastName': 'Litt', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States. Electronic address: Dana.Litt@unthsc.edu.'}, {'ForeName': 'Tracey A', 'Initials': 'TA', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, Murray State University, Murray, KY, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Lowery', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Cassidy', 'Initials': 'C', 'LastName': 'LoParco', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Annalynn M', 'Initials': 'AM', 'LastName': 'Galvin', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Box 354944, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106398'] 3130,32247085,"An Invited Commentary on ""comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to eight weeks later: A randomized controlled trial"" (Int J Surg 2020;76:37-44).",,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]",[],,0.137814,,"[{'ForeName': 'Maria Michela', 'Initials': 'MM', 'LastName': 'Chiarello', 'Affiliation': 'Department of Surgery, General Surgery Operative Unit, ""San Giovanni di Dio"" Hospital, Crotone, Italy. Electronic address: mikikr2001@gmail.com.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Brisinda', 'Affiliation': 'Department of Surgery, Catholic School of Medicine, ""Agostino Gemelli"" Hospital, Rome, Italy.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.062'] 3131,32103747,Using point-of-care C-reactive protein to guide antibiotic prescribing for lower respiratory tract infections in elderly nursing home residents (UPCARE): study design of a cluster randomized controlled trial.,"BACKGROUND Antibiotics are over-prescribed for lower respiratory tract infections (LRTI) in nursing home residents due to diagnostic uncertainty. Inappropriate antibiotic use is undesirable both on patient level, considering their exposure to side effects and drug interactions, and on societal level, given the development of antibiotic resistance. C-reactive protein (CRP) point-of-care testing (POCT) may be a promising diagnostic tool to reduce antibiotic prescribing for LRTI in nursing homes. The UPCARE study will evaluate whether the use of CRP POCT for suspected LRTI is (cost-) effective in reducing antibiotic prescribing in the nursing home setting. METHODS/DESIGN A cluster randomized controlled trial will be conducted in eleven nursing homes in the Netherlands, with the nursing home as the unit of randomization. Residents with suspected LRTI who reside at a psychogeriatric, somatic, or geriatric rehabilitation ward are eligible for study participation. Nursing homes in the intervention group will provide care as usual with the possibility to use CRP POCT, and the control group will provide care as usual without CRP POCT for residents with (suspected) LRTI. Data will be collected from September 2018 for approximately 1.5 year, using case report forms that are integrated in the electronic patient record system. The primary study outcome is antibiotic prescribing for suspected LRTI at index consultation (yes/no). DISCUSSION This is the first randomised trial to evaluate the effect of nursing home access to and training in the use of CRP POCT on antibiotic prescribing for LRTI, yielding high-level evidence and contributing to antibiotic stewardship in the nursing home setting. The relatively broad inclusion criteria and the pragmatic study design add to the applicability and generalizability of the study results. TRIAL REGISTRATION Netherlands Trial Register, Trial NL5054. Registered 29 August 2018.",2020,C-reactive protein (CRP) point-of-care testing (POCT) may be a promising diagnostic tool to reduce antibiotic prescribing for LRTI in nursing homes.,"['eleven nursing homes in the Netherlands, with the nursing home as the unit of randomization', 'elderly nursing home residents (UPCARE', 'Residents with suspected LRTI who reside at a psychogeriatric, somatic, or geriatric rehabilitation ward are eligible for study participation']","['CRP POCT', 'C-reactive protein (CRP) point-of-care testing (POCT']",['antibiotic prescribing for suspected LRTI at index consultation (yes/no'],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0017467', 'cui_str': 'Psychogeriatrics'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1319069', 'cui_str': 'Point-of-Care Testing'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]",,0.108095,C-reactive protein (CRP) point-of-care testing (POCT) may be a promising diagnostic tool to reduce antibiotic prescribing for LRTI in nursing homes.,"[{'ForeName': 'Tjarda M', 'Initials': 'TM', 'LastName': 'Boere', 'Affiliation': 'Department of General Practice & Old Age Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'van Buul', 'Affiliation': 'Department of General Practice & Old Age Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, location VU University Medical Center, Amsterdam, the Netherlands. l.vanbuul@amsterdamumc.nl.'}, {'ForeName': 'Rogier M', 'Initials': 'RM', 'LastName': 'Hopstaken', 'Affiliation': 'Star-SHL diagnostic centers, Etten-Leur, the Netherlands.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Veenhuizen', 'Affiliation': 'Department of General Practice & Old Age Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'Jochen W L', 'Initials': 'JWL', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Theo J M', 'Initials': 'TJM', 'LastName': 'Verheij', 'Affiliation': 'National lnstitute for Public Health and the Environment (RlVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Cees M P M', 'Initials': 'CMPM', 'LastName': 'Hertogh', 'Affiliation': 'Department of General Practice & Old Age Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Center, location VU University Medical Center, Amsterdam, the Netherlands.'}]",BMC health services research,['10.1186/s12913-020-5006-0'] 3132,31999146,"""Parenting time, parenting quality, interparental conflict, and mental health problems of children in high-conflict divorce"": Correction to O'Hara et al. (2019).","Reports an error in ""Parenting time, parenting quality, interparental conflict, and mental health problems of children in high-conflict divorce"" by Karey L. O'Hara, Irwin N. Sandler, Sharlene A. Wolchik, Jenn-Yun Tein and C. Aubrey Rhodes ( Journal of Family Psychology , 2019[Sep], Vol 33[6], 690-703). In the article, the last sentence of the first paragraph under the heading ""Are There Nonlinear Associations Between PT and PQ and IPC?"" in the Discussion section incorrectly closes with ""somewhere between 33% and 40% time with each parent."" Instead, the text should read ""somewhere between 33% and 40% time with the father."" (The following abstract of the original article appeared in record 2019-40282-001.) Despite widespread acknowledgment that ""frequent, continuing, and meaningful"" (Pruett & DiFonzo, 2014) time with both parents is beneficial for children from divorced or separated families, and that interparental conflict (IPC) is associated with increased child mental health problems, the joint effects of parenting time (PT), parenting quality (PQ), and IPC on children's mental health problems are less clear. The current study integrates two theoretical models in multiple mediator analyses to test indirect effects of mothers' and fathers' PQ and IPC to explain the association between PT and children's mental health problems within the same model. Participants were children aged 9-18 years ( N = 141) who had one or both parents participate in a randomized comparative effectiveness trial of a court-based prevention program for high-conflict divorcing or separating families. Data were collected at pretest and 9-month follow-up. Analyses revealed an indirect effect in which fathers' PQ mediated the association between PT and child internalizing problems both concurrently and 9 months later. There were no significant indirect effects involving IPC. Analyses indicated a significant quadratic relation between PT and fathers' PQ, suggesting that although more PT is associated with better father-child relationships, there is a point beyond which more time is not related to a better relationship. We discuss the study findings, research limitations, and implications for public policy. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,There were no significant indirect effects involving IPC.,['Participants were children aged 9-18 years ( N = 141) who had one or both parents participate'],['court-based prevention program for high-conflict divorcing or separating families'],"['Parenting time, parenting quality, interparental conflict, and mental health problems', 'parenting time (PT), parenting quality (PQ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1955961', 'cui_str': 'Interparental Conflict'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]",,0.0212283,There were no significant indirect effects involving IPC.,[],Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000626'] 3133,30374191,Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies.,"The endogenous opioid system is thought to play an important role in the regulation of mood. Buprenorphine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive treatment of major depressive disorder (MDD). To confirm results from early studies, we report the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and an inadequate response to antidepressant therapy (ADT) in FORWARD-4 and FORWARD-5: two phase 3, randomized, double-blind, placebo-controlled studies that utilized the same sequential parallel-comparison design. Efficacy was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). FORWARD-5 achieved the primary endpoint and demonstrated that adjunctive BUP/SAM 2 mg/2 mg was superior to placebo (average difference change from baseline to week 3 through end of treatment [EOT] in MADRS-6 and -10 versus placebo: -1.5, P = 0.018; -1.9, P = 0.026, respectively). FORWARD-4 did not achieve the primary endpoint (change from baseline in MADRS-10 at week 5 versus placebo: -1.8, P = 0.109), although separate analyses showed significant treatment differences at other timepoints using traditional, regulatory-accepted endpoints such as reduction in MADRS-10 at EOT. The pooled analysis of the two studies demonstrated consistently greater reduction in MADRS-10 scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple timepoints including EOT and average change from baseline to week 3 through EOT (-1.8, P = 0.010; -1.8, P = 0.004, respectively). The overall effect size (Hedges' g) in the pooled analyses for MADRS-10 change from baseline to EOT was 0.22. Overall, BUP/SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity. The most common AEs, occurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment group, which was more frequently than the placebo group, included nausea, constipation, dizziness, vomiting, somnolence, fatigue, and sedation. There was minimal evidence of abuse, and no evidence of dependence or opioid withdrawal by AEs or objective measures. This report describes adjunctive BUP/SAM 2 mg/2 mg combination, a therapy with a novel opioidergic mechanism of action, as a potential new treatment option for patients with MDD who have an inadequate response to currently available ADT.",2020,,['major depressive disorder'],['buprenorphine/samidorphan combination'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]",[],,0.231079,,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (CTNI), Harvard Medical School, Boston, MA, USA. MFAVA@mgh.harvard.edu.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine and the Corporal Michael Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Memisoglu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0284-1'] 3134,32246302,Appropriate stage of Descemet membrane removal during donor preparation in deep anterior lamellar keratoplasty.,"PURPOSE To investigate the appropriate surgical stage for Descemet membrane (DM) removal during donor preparation in deep anterior lamellar keratoplasty (DALK). METHODS This study included 83 corneoscleral buttons that were used for DALK. The donor DM was removed randomly either before (group 1; 43 eyes) or after (group 2; 40 eyes) trephination. The time required for DM removal was recorded, and the geometric properties of cut buttons were evaluated after trephination. The intraoperative video recordings were reviewed to determine if the dissections were performed at the stroma-DM plane as it was intended. The time needed to remove the DM, the rate of correct dissection at the intended stroma-DM plane, and the roundness and precision of the donor cuts were compared between the groups. RESULTS The two groups were comparable in donor characteristics, including age, quality of the tissue, and trephination size. Time spent to remove DM was significantly shorter in group 1 (68.9 ± 48.2 s) than group 2 (117.7 ± 52.7 s, P = 0.001). DM stripping was performed incorrectly in 2 corneas (4.7%) in group 1 and in 12 corneas (30%) in group 2 (P = 0.01). No difference was found between the groups in the roundness and precision of donor button cuts. CONCLUSIONS DM removal before trephination did not detrimentally affect the geometric properties of punched donor tissues. When DM stripping was performed before trephination, the donor tissue was less traumatized and posterior graft surface was more likely to be regular; therefore, it is advisable to remove DM before trephination during donor preparation for DALK.",2020,"No difference was found between the groups in the roundness and precision of donor button cuts. ",['83 corneoscleral buttons that were used for DALK'],[],"['DM stripping', 'geometric properties of punched donor tissues', 'Time spent to remove DM', 'geometric properties of cut buttons', 'time required for DM removal', 'roundness and precision of donor button cuts']","[{'cui': 'C0453985', 'cui_str': 'Button'}]",[],"[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0182555', 'cui_str': 'Punch'}, {'cui': 'C0040288', 'cui_str': 'Tissue donor'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]",83.0,0.0617915,"No difference was found between the groups in the roundness and precision of donor button cuts. ","[{'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Feizi', 'Affiliation': 'Department of Ophthalmology, Ophthalmic Research Center, Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9 St., Pasdaran Ave., Tehran, 16666, Iran. sepehrfeizi@yahoo.com.'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Azari', 'Affiliation': 'Department of Ophthalmology, Ophthalmic Research Center, Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9 St., Pasdaran Ave., Tehran, 16666, Iran.'}]",International ophthalmology,['10.1007/s10792-020-01352-1'] 3135,32067249,"Pharmacokinetics, pharmacodynamics and safety of the inverse retinoic acid-related orphan receptor γ agonist AZD0284.","AIMS Retinoic acid-related orphan receptor γ (RORγ), a master regulator of T-helper 17 (Th17) cell function and differentiation, is an attractive target for treatment of Th17-driven diseases. This first-in-human study aimed to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of the inverse RORγ agonist AZD0284. METHODS We conducted a phase I, randomized, single-blind, placebo-controlled, two-part, first-in-human study with healthy subjects receiving single (4-238 mg) or multiple (12-100 mg) oral doses of AZD0284 or placebo after overnight fasting. Subjects in the one single dose cohort additionally received a single dose of AZD0284 after a high-calorie meal. AZD0284 plasma concentrations, as well as inhibition of ex vivo-stimulated interleukin (IL)-17A release in whole blood, were frequently measured after both single and multiple dosing. RESULTS Eighty-three men participated in the study. AZD0284 was absorbed rapidly into plasma after oral dosing and exhibited a terminal half-life of 13-16 hours. Both the area under the concentration-time curve (AUC) and maximum concentration (C max ) increased subproportionally with increasing dose (95% confidence intervals of slope parameter were 0.71-0.84 and 0.72-0.88 for AUC and C max , respectively). Food intake delayed the absorption of AZD0284 but did not affect the overall exposure or half-life. AZD0284 showed dose-dependent reduction of ex vivo-stimulated IL-17A release after both single and multiple doses. No significant safety concerns were identified in the study. CONCLUSIONS AZD0284 was well tolerated, rapidly and dose-dependently absorbed, and reduced stimulated IL-17A release after single and multiple dosing. The results of this study support further clinical development of AZD0284.",2020,AZD0284 showed dose-dependent reduction of ex vivo stimulated IL-17A release after both single and multiple doses.,"['healthy subjects receiving single (4 mg to 238 mg) or multiple (12 to 100 mg', 'Eighty-three men participated in the study']","['Retinoic Acid-Related Orphan Receptor γ (RORγ', 'placebo', 'oral doses of AZD0284 or placebo']","['pharmacokinetics, pharmacodynamics, safety, and tolerability', 'stimulated IL-17A release', 'reduction of ex vivo stimulated IL-17A release', 'AZD0284 plasma concentrations', 'concentration-time curve (AUC) and maximum concentration (C max ', 'Pharmacokinetics, Pharmacodynamics, and Safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",83.0,0.0857159,AZD0284 showed dose-dependent reduction of ex vivo stimulated IL-17A release after both single and multiple doses.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Asimus', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca Gaithersburg, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Palmér', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca Gothenburg, Sweden.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Early Phase Clinical Unit, Parexel, London, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Forsman', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lundin', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Olsson', 'Affiliation': 'Early Biostats and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Pehrson', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Patient Safety, Respiratory, Inflammation and Autoimmunity, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Muir', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'Study Delivery, Early Oncology Clinical, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Carlert', 'Affiliation': 'Early Product Development, Pharmaceutical Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Close', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Keeling', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",British journal of clinical pharmacology,['10.1111/bcp.14253'] 3136,32129141,One-year follow-up of efficacy and cost of repeated doses versus single larger dose of intra-articular hyaluronic acid for knee osteoarthritis.,"PURPOSE A recent 3-month randomized, open-label controlled trial found that the intra-articular hyaluronic acid injection (GO-ON ® ) given as a single dose of 5 mL is as effective and safe as three repeated doses of 2.5 mL in patients with knee osteoarthritis. However, the information on the long-term efficacy and economic implications of the single-dose regimen is still limited. Hence, this follow-up study was designed to compare the effectiveness and costs of the two regimens 12 months following the treatment. METHODS All the 127 patients, who received either three repeated doses ( n = 64) or a single dose ( n = 63) of GO-ON in the previous trial, were followed up in month 12 following the treatment. The effectiveness of both the regimens was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the mean WOMAC scores were compared with those recorded at the baseline and in month 3. Additionally, the total treatment costs of the two regimens, taking account of both direct and indirect costs, were computed and compared. RESULTS A total of 125 patients (98.4%) completed the assessment. Despite the reduction of the overall mean WOMAC score from 39.24 to 19.93 ( p < 0.001) in the first 3 months following the treatment with GO-ON, no further changes were observed up to month 12 ( p > 0.95). In the meantime, the two regimens did not differ in the mean WOMAC scores ( p = 0.749) and in the subscale scores for pain ( p = 0.970), stiffness ( p = 0.526), and physical functioning ( p = 0.667) in month 12. The cost for single-dose injection was found to be approximately 30% lower compared to the repeated doses. CONCLUSION These findings indicate that the single larger dose of GO-ON is as effective as the repeated doses over 12 months, and yet the total treatment cost is lowered.",2020,"In the meantime, the two regimens did not differ in the mean WOMAC scores ( p = 0.749) and in the subscale scores for pain ( p = 0.970), stiffness ( p = 0.526), and physical functioning ( p = 0.667) in month 12.","['knee osteoarthritis', 'patients with knee osteoarthritis', 'A total of 125 patients (98.4%) completed the assessment', '127 patients']","['intra-articular hyaluronic acid', 'intra-articular hyaluronic acid injection (GO-ON ® ']","['subscale scores for pain', 'overall mean WOMAC score', 'effectiveness and costs', 'physical functioning', 'mean WOMAC scores', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the mean WOMAC scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}]",127.0,0.0276996,"In the meantime, the two regimens did not differ in the mean WOMAC scores ( p = 0.749) and in the subscale scores for pain ( p = 0.970), stiffness ( p = 0.526), and physical functioning ( p = 0.667) in month 12.","[{'ForeName': 'Vijaya Kumar L', 'Initials': 'VKL', 'LastName': 'Suppan', 'Affiliation': 'Department of Orthopaedics, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.'}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Tew', 'Affiliation': 'Clinical Research Centre, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.'}, {'ForeName': 'Bor Chern', 'Initials': 'BC', 'LastName': 'Wong', 'Affiliation': 'Department of Orthopaedics, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.'}, {'ForeName': 'Huan Keat', 'Initials': 'HK', 'LastName': 'Chan', 'Affiliation': 'Clinical Research Centre, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.'}, {'ForeName': 'Yu Wei', 'Initials': 'YW', 'LastName': 'Chew', 'Affiliation': 'Department of Orthopaedics, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.'}, {'ForeName': 'Chin Siong', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedics, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.'}, {'ForeName': 'Vijay Kumar', 'Initials': 'VK', 'LastName': 'Nanta Kumar', 'Affiliation': 'Department of Orthopaedics, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.'}, {'ForeName': 'Asrul Akmal', 'Initials': 'AA', 'LastName': 'Shafie', 'Affiliation': 'School of Pharmaceutical Science, Universiti Sains Malaysia, Gelugor, Penang, Malaysia.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Sadashiva Rao', 'Affiliation': 'Faculty of Medicine, Melaka Manipal Medical College, Melaka, Malaysia.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019895029'] 3137,31586371,Photogrammetric Analysis of Upper Cross Syndrome among Teachers and the Effects of National Academy of Sports Medicine Exercises with Ergonomic Intervention on the Syndrome.,"BACKGROUND Hyperkyphosis is often accompanied by forward head and shoulder postures. Together, these three disorders are called ""Upper Cross Syndrome (UCS)"". We aimed to perform a photogrammetric analysis of UCS among teachers and to determine the effects of National Academy of Sports Medicine (NASM) exercises with ergonomic training interventions on the syndrome. STUDY DESIGN A semi-experimental study. METHODS Photogrammetric analysis was performed using the UCS software among teachers in order to determine the angles of forward head, rounded shoulders, and hyperkyphosis. Twenty-three teachers were selected purposefully and enrolled in Fasa City in 2018. They were randomly divided into experimental (n=12) and control (n=11) groups. Experimental group attended 12 wk of NASM exercises with ergonomic intervention but the control group did not participate in any regular exercise. The data were analyzed using paired t-test and differential independent t-test (P<0.05). RESULTS The results indicated a significant decrease in forward head (P=0.001), shoulder angles (P=0.000) and hyperkyphosis (P=0.003). The applied intervention had a 90% positive effect in reducing the forward head angle, an 88% positive effect in reducing the rounded shoulder angle and a 90% positive effect in reducing the kyphosis angle. However, the results for the control group did not show a significant difference for forward head, rounded shoulders, and hyperkyphosis angles. CONCLUSION The UCS software application can be used as an accurate instrument for measuring the extent of the UCS. Moreover, using NASM exercises can lead to a reduction in the UCS among teachers.",2019,"The results indicated a significant decrease in forward head (P=0.001), shoulder angles (P=0.000) and hyperkyphosis (P=0.003).",['Twenty-three teachers were selected purposefully and enrolled in Fasa City in 2018'],"['NASM exercises', 'NASM exercises with ergonomic intervention but the control group did not participate in any regular exercise', 'Sports Medicine Exercises with Ergonomic Intervention', 'Sports Medicine (NASM) exercises with ergonomic training interventions']","['kyphosis angle', 'forward head', 'shoulder angles', 'rounded shoulder angle']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086246', 'cui_str': 'Ergonomics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0038040', 'cui_str': 'Sports Medicine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0022823'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]",23.0,0.0166266,"The results indicated a significant decrease in forward head (P=0.001), shoulder angles (P=0.000) and hyperkyphosis (P=0.003).","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Karimian', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Rahnama', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran. rahnamanader@yahoo.com.'}, {'ForeName': 'Gholamali', 'Initials': 'G', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Lenjannejadian', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, School of Sport Sciences, University of Isfahan, Isfahan, Iran.'}]",Journal of research in health sciences,[] 3138,31404005,"Health-related Quality of Life Following Hybrid Minimally Invasive Versus Open Esophagectomy for Patients With Esophageal Cancer, Analysis of a Multicenter, Open-label, Randomized Phase III Controlled Trial: The MIRO Trial.","BACKGROUND Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer. OBJECTIVES The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial. METHODS We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18. RESULTS The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia. CONCLUSIONS Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.",2020,"At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303).","['Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus', '13 study centers between 2009 and 2012', 'Patients With Esophageal Cancer']","['Minimally Invasive Versus Open Esophagectomy', 'open esophagectomy (OE', 'Hybrid minimally invasive esophagectomy (HMIE', 'transthoracic OE or HMIE', 'HMIE and OE']","['pain', 'Postoperative complications', 'Health-related Quality of Life', 'social functioning', 'short- and long-term health-related quality of life (HRQOL', 'global HRQOL', 'role functioning, pain, and dysphagia', 'role functioning [-33.33 (HMIE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4517717', 'cui_str': 'Thirty-three point three three'}]",13.0,0.257365,"At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303).","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, University Lille, Lille, France.'}, {'ForeName': 'Sheraz', 'Initials': 'S', 'LastName': 'Markar', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, United Kingdom.'}, {'ForeName': 'Tienhan Sandrine', 'Initials': 'TS', 'LastName': 'Dabakuyo-Yonli', 'Affiliation': 'Epidemiology and Quality of Life Unit, INSERM 1231 Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Department of Hepatobiliary and Digestive Surgery, CHU of Rennes, University of Rennes 1, Rennes, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': 'Department of Digestive and Hepatobiliary Surgery, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Collet', 'Affiliation': 'Department of Digestive Surgery, Haut Lévèque University Hospital, Bordeaux, France.'}, {'ForeName': 'Xavier Benoit', 'Initials': 'XB', 'LastName': ""D'Journo"", 'Affiliation': 'Department of Thoracic Surgery, Hôpital Nord, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Perniceni', 'Affiliation': 'Department of Digestive Surgery, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Carrere', 'Affiliation': 'Department of Digestive Surgery, Purpan Hospital, CHU Toulouse, Université Toulouse III, CRCT UMR, Toulouse, France.'}, {'ForeName': 'Jean Yves', 'Initials': 'JY', 'LastName': 'Mabrut', 'Affiliation': 'Department of General Surgery and Liver Transplantation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of Digestive and General Surgery, CHU Louis Mourier, AP-HP, Université Paris 7, Denis Diderot PRES Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Peschaud', 'Affiliation': 'Department of Surgery and Oncology, Centre Hospitalier Universitaire Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Université de Versailles, Boulogne-Billancourt, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Prudhomme', 'Affiliation': 'Digestive Surgery Department, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Methodology and Quality of Life Unit in Cancer, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, University Lille, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003559'] 3139,32125668,Effects of Autograft Types on Muscle Strength and Functional Capacity in Patients Having Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.,"BACKGROUND The effects of different autograft types for anterior cruciate ligament reconstruction (ACL-R) on muscle function are sparsely investigated in randomized controlled trials. Our aim was to investigate the effects of quadriceps tendon autograft (QTB) vs. semitendinosus-gracilis autograft (StG) on thigh muscle strength and functional capacity, and a patient-reported outcome 1 year after ACL-R, and to compare the results to healthy controls. METHODS ACL-R patients (n = 100) and matched controls (CON, n = 50) were recruited, with patients being randomly assigned to QTB (n = 50) or StG (n = 50) ACL-R. One year after ACL-R, bilateral knee extensor (KE) and flexor (KF) muscle strength (isometric, dynamic, explosive, limb symmetry index [LSI], hamstring:quadriceps ratio [HQ ratio]) were assessed by isokinetic dynamometry, along with functional capacity (single leg hop distance [SHD]) and a patient-reported outcome (International Knee Documentation Committee [IKDC] score). RESULTS KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI. HQ ratios were lower in StG vs. QTB. Compared with the controls, KE and KF muscle strength were lower in StG (10-22%), while KE muscle strength only was lower in QTB (16-25%). Muscle strength in the StG, QTB, and CON groups was identical in the non-operated leg. While SHD and IKDC did not differ between StG and QTB, SHD in both StG and QTB was lower than CON. The IKDC scores improved significantly 1 year following ACL-R for both graft types. CONCLUSION One year after ACL-R, muscle strength is affected by autograft type, with StG leading to impairments of KE and KF muscle strength, while QTB results in more pronounced impairments of KE only. Functional capacity and patient-reported outcome were unaffected by autograft type, with the former showing impairment compared to healthy controls. CLINICAL TRIALS REGISTRATION NUMBER NCT02173483.",2020,"RESULTS KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI.","['Patients', 'Having Anterior Cruciate Ligament Reconstruction', 'ACL-R patients (n\u2009=\u2009100) and matched controls (CON, n\u2009=\u200950']","['quadriceps tendon autograft (QTB) vs. semitendinosus-gracilis autograft (StG', 'Autograft Types', 'QTB', 'StG (n\u2009=\u200950) ACL-R. One year after ACL-R, bilateral knee extensor (KE) and flexor (KF) muscle strength (isometric, dynamic, explosive, limb symmetry index [LSI], hamstring:quadriceps ratio [HQ ratio]) were assessed by isokinetic dynamometry, along with functional capacity (single leg hop distance [SHD', 'anterior cruciate ligament reconstruction (ACL-R']","['patient-reported outcome (International Knee Documentation Committee [IKDC] score', 'KE muscle strength of the operated leg', 'IKDC scores', 'KE and KF muscle strength', 'thigh muscle strength and functional capacity', 'Muscle Strength and Functional Capacity', 'KE muscle strength', 'Muscle strength', 'KF muscle strength', 'HQ ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0471684,"RESULTS KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI.","[{'ForeName': 'Kasper Staghøj', 'Initials': 'KS', 'LastName': 'Sinding', 'Affiliation': 'Department of Sports Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torsten Grønbech', 'Initials': 'TG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Sports Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars Grøndahl', 'Initials': 'LG', 'LastName': 'Hvid', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark. dalgas@ph.au.dk.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-020-01276-x'] 3140,32122717,Effects of spinal immobilization at 20° on end-tidal carbon dioxide.,"OBJECTIVE The aim was to determine the effect on end-tidal carbon dioxide (ETCO 2 ) of spinal immobilization (SI) at a conventional 0° angle and to investigate the usefulness of immobilization at a 20° angle for preventing possible hypoventilation. METHODS The study included 80 healthy volunteers, randomly divided into two groups. Spinal backboards and cervical collars were applied in Group 1 using a 0° angle and in Group 2 using a 20° angle, with the head up. SI was continued for 1 h, and ETCO 2 values were measured at the 0th, 30th and 60th minute. RESULTS There were no significant differences between the groups in 0th and 30th minute ETCO 2 . However, after 60th minute, results showed a statistically significant increase in ETCO 2 in Group 1 (35.5 mmHg [IQR 25-75:35-38]) compared to Group 2 (34 mmHg [IQR 25-75:33-36]) (p < 0.001). During SI, there was a statistically significant increase in ETCO 2 in Group 1 (35 mmHg [IQR 25-75:34-36], 35.5 mmHg [IQR 25-75:34-37] and 36 mmHg [IQR 25-75:35-38] respectively at the 0th, 30th and 60th minute after SI) (p < 0.001) and no change in Group 2. Also, we found statistically significant differences between ΔETCO 2 levels in Groups 1 and 2 at all 3 time intervals. CONCLUSION Conventional SI with an angle of 0° led to an increase in ETCO 2 while subjects immobilization at a 20° angle maintained their initial ETCO 2 values. Immobilization at 20° may prevent decompensation in patients who have thoracic trauma or lung diseases or those who are elderly, pregnant, or obese.",2020,"Also, we found statistically significant differences between ΔETCO 2 levels in Groups 1 and 2 at all 3 time intervals. ","['patients who have thoracic trauma or lung diseases or those who are elderly, pregnant, or obese', '80 healthy volunteers']","['tidal carbon dioxide (ETCO 2 ) of spinal immobilization (SI', 'Conventional SI', 'spinal immobilization']",['ETCO'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]",[],80.0,0.0267368,"Also, we found statistically significant differences between ΔETCO 2 levels in Groups 1 and 2 at all 3 time intervals. ","[{'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Dağar', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey. Electronic address: sedadagar@gmail.com.'}, {'ForeName': 'Şeref Kerem', 'Initials': 'ŞK', 'LastName': 'Çorbacıoğlu', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Emektar', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Uzunosmanoğlu', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}, {'ForeName': 'Yunsur', 'Initials': 'Y', 'LastName': 'Çevik', 'Affiliation': 'Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.02.042'] 3141,32077134,"Effects, costs and implementation of monitoring kidney transplant patients' tacrolimus levels with dried blood spot sampling: A randomized controlled hybrid implementation trial.","AIMS Dried blood spot (DBS) home sampling allows monitoring creatinine levels and tacrolimus trough levels as an alternative for blood sampling in the hospital, which is important in kidney transplant patient follow-up. This study aims to assess whether DBS home sampling results in decreased patient travel burden and lower societal costs. METHODS In this single-centre randomized controlled hybrid implementation trial, adult kidney transplant patients were enrolled. The intervention group (n = 25) used DBS home sampling on top of usual care in the first 6 months after transplantation. The control group (n = 23) received usual care only. The primary endpoint was the number of outpatient visits. Other endpoints were costs per patient, patient satisfaction and implementation. RESULTS There was no statistically significant difference in the average number of outpatient visits between the DBS group (11.2, standard deviation: 1.7) and the control group (10.9, standard deviation: 1.4; P = .48). Average costs per visit in the DBS group were not significantly different (€542, 95% confidence interval €316-990) compared to the control group (€533, 95% confidence interval €278-1093; P = .66). Most patients (n = 19/23, 82.6%) were willing to perform DBS home-sampling if this would reduce the number of hospital visits. Only 55.9% (n = 143/256) of the expected DBS samples were received and 1/5 analysed on time (n = 52/256). CONCLUSION Adult kidney transplant patients are willing to perform DBS home sampling. However, to decrease patient travel burden and costs in post-transplant care, optimization of the logistical process concerning mailing and analysis of DBS samples is crucial.",2020,"Average costs per visit in the DBS group were not significantly different (€542, 95%CI €","['Adult kidney transplant patients', 'adult kidney transplant patients were enrolled', ""kidney transplant patients' tacrolimus levels with Dried Blood Spot sampling""]","['Dried Blood Spot (DBS', 'usual care only', 'DBS home sampling']","['average number of outpatient visits', 'costs per patient (2) patient satisfaction and (3) implementation', 'patient travel burden and lower societal costs', 'number of outpatient visits', 'Average costs per visit', 'number of hospital visits']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.114818,"Average costs per visit in the DBS group were not significantly different (€542, 95%CI €","[{'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Veenhof', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Job Frank Martien', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'van der Voort', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stefan Philip', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stephanus Johannes Leonardus', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daniël Johannes', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14249'] 3142,31916979,Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study.,"BACKGROUND This randomized phase II study tested the hypothesis that schedule dependent chemo-immunotherapy with oregovomab improves progression free survival (PFS) and overall survival (OS) in optimally resected, Stage III/IV ovarian cancer. METHODS Patients from both academic centers and private practice in the US and Italy with Stage III/IV optimally cytoreduced ovarian cancer were randomized to standard six cycle IV carboplatin-paclitaxel chemotherapy (CP) versus CP plus four immunizations with oregovomab (CPO). A translational assessment of a cellular immune response was the primary endpoint; PFS and OS were measured as secondary endpoints. FINDINGS 97 patients at thirteen centers were accrued to the protocol, 47 to CPO and 50 to CP. Technical issues led to inconsistent performance of the primary CA125 ELISPOT leading to unevaluable results. At a median follow up of 42 months, PFS and OS outcomes revealed an unexpectedly large treatment effect for CPO relative to CP alone, with median PFS of 41.8 months (95% C.I.: 21.8 - N.E.) for CPO and 12.2 months (10.4-18.6) for CP (p = 0.0027, HR 0.46, CI 0.28-0.7). For OS, the median for CPO has not yet been reached (NE) (45.2-NE) and for CP was 43.2 months (31.8-NE) (p = 0.043, HR 0.35, CI 0.16-0.74). The oregovomab treatment resulted in no change in toxicity profile from CP. INTERPRETATION The previously identified potential clinical benefit of IV CP when administered with oregovomab was further refined in this randomized phase II study. Increases of PFS and OS of statistically and clinically significant magnitude were evident in this study of a front line chemo-immunotherapy treatment of ovarian cancer.",2020,Increases of PFS and OS of statistically and clinically significant magnitude were evident in this study of a front line chemo-immunotherapy treatment of ovarian cancer.,"['advanced ovarian cancer', 'Patients from both academic centers and private practice in the US and Italy with Stage III/IV optimally cytoreduced ovarian cancer', '97 patients at thirteen centers were accrued to the protocol, 47 to CPO and 50 to CP']","['IV CP', 'Front-line chemo-immunotherapy with carboplatin-paclitaxel', 'standard six cycle IV carboplatin-paclitaxel chemotherapy (CP) versus CP plus four immunizations with oregovomab (CPO']","['toxicity profile', 'PFS and OS', 'progression free survival (PFS) and overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4521536', 'cui_str': 'United States Military enlisted E7 (qualifier value)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0664207', 'cui_str': 'oregovomab'}, {'cui': 'C4521536', 'cui_str': 'United States Military enlisted E7 (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",97.0,0.170682,Increases of PFS and OS of statistically and clinically significant magnitude were evident in this study of a front line chemo-immunotherapy treatment of ovarian cancer.,"[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Brewer', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, United States of America. Electronic address: mbrewer@uchc.edu.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Angioli', 'Affiliation': 'Campus Biomedico of Rome, Rome, Italy.'}, {'ForeName': 'Giovani', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy; Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Terranova', 'Affiliation': 'Campus Biomedico of Rome, Rome, Italy.'}, {'ForeName': 'Pierluigi Benedetti', 'Initials': 'PB', 'LastName': 'Panici', 'Affiliation': 'Policlinico di Roma ""Umberto I"", Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unita operative Ostetricia e Ginecologia, Dipartimento Materno Infantile Ospedale Cannizzario di Catania, Catania, Italy.'}, {'ForeName': 'Francessco', 'Initials': 'F', 'LastName': 'Plotti', 'Affiliation': 'Campus Biomedico of Rome, Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Ferrandina', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Salutari', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Ricci', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Braly', 'Affiliation': 'Womens Cancer Care, Covington, LA, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Holloway', 'Affiliation': 'AdventHealth Cancer, Orlando, FL, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Method', 'Affiliation': 'Michiana Hematology Oncology, South Bend, IN, United States of America.'}, {'ForeName': 'Madi', 'Initials': 'M', 'LastName': 'Madiyalakan', 'Affiliation': 'OncoQuest Inc., Edmonton, Alberta, Canada.'}, {'ForeName': 'Eliel', 'Initials': 'E', 'LastName': 'Bayever', 'Affiliation': 'OncoQuest Inc., Edmonton, Alberta, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nicodemus', 'Affiliation': 'AIT Strategies, Franconia, NH, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.12.024'] 3143,32110003,Lifestyle Matters Randomized Controlled Trial of a Preventive Health Intervention for Older People: Qualitative Sub Study with Participants and Intervention Facilitators.,"Objective This qualitative study embedded within a randomized controlled trial was conducted to explore the acceptability, experiences of, and short-term impact of a preventive health intervention (Lifestyle Matters) from the perspectives of those who took part, and to uncover any evidence for the theorised mechanisms of action (improved participation and self efficacy) underpinning the intervention. It was also conducted to help explain the quantitative trial results. Methods A purposive sample of 13 trial participants who had been randomized to receive the Lifestyle Matters intervention (approximately 10%) were individually qualitatively interviewed immediately following their involvement. All four intervention facilitators were also individually interviewed. Results Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention. However, lack of adherence to the overall intervention eroded receipt of benefit. This finding complements the quantitative trial results which found that the study had failed to recruit those who considered themselves to be at risk of age-related decline. Conclusion This form of preventive health intervention requires proactive identification of those who recognise the need to make lifestyle changes. This is difficult if reactive health and social care systems are the main referral routes. The methodological approaches taken towards the study of complex interventions requires reconsideration if potential benefits are to be accurately assessed. Clinical Trial Registration ISRCTN67209155.",2020,"Results Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention.","['Methods\n\n\nA purposive sample of 13 trial participants who had been randomized to receive the', 'Older People']","['preventive health intervention (Lifestyle Matters', 'Preventive Health Intervention', 'Lifestyle Matters intervention']",[],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0033109', 'cui_str': 'Preventive Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",[],13.0,0.0902491,"Results Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention.","[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mountain', 'Affiliation': 'School of Health and Related Research, Faculty of Medicine, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Sprange', 'Affiliation': 'Faculty of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Chatters', 'Affiliation': 'School of Health and Related Research, Faculty of Medicine, University of Sheffield, Sheffield, UK.'}]",Clinical interventions in aging,['10.2147/CIA.S232108'] 3144,31924318,Usefulness of a Structured Adult Education Program in Modifying Markers of Cardiovascular Risk After Acute Myocardial Infarction.,"Patient involvement in therapeutic strategies leading to lifestyle changes and increasing adherence to beneficial treatment is important for high risk coronary artery disease patients. The hypothesis of the present substudy was that a program of education specifically structured to educate postmyocardial infarction patients would lead to measurable differences in specific indices of cardiovascular risk. Post-MI patients were randomly assigned to 2 groups. Patients in the intervention arm attended an 8-week long educational program in addition to usual treatment and controls received standard treatment. Low-density lipoprotein cholesterol, systolic blood pressure, body-mass index, and glycosylated hemoglobin were assessed at baseline and at 12 months (values are reported as median [interquartile range]). One hundred ninety-eight consecutively randomized patients were included in the present substudy. The median change in Low-density lipoprotein cholesterol was -54 (-45 to [-62]) mg/dl in the intervention group as compared with -35 (-28 to [-43]) mg/dl in controls (p <0.001). Systolic blood pressure change was -7.5 (-15.3 to 0.3) mm Hg and -3.0 (-11.8 to 2.8) mm Hg, respectively (p = 0.011). The median change in body-mass index was 0.0 (-3.0 to 3.0) kg/m 2 as compared with 2.0 (-1.0 to 3.9) kg/m 2 , respectively (p = 0.002). The reduction in glycosylated hemoglobin was significant in both groups with a median absolute change of -0.29 (-1.11 to 0.09) % in the intervention group and -0.24 (-0.69 to 0.06) % in controls (p = 0.168). If only diabetic patients were considered, the change was -0.65 (-1.3 to [-0.23]) % in the intervention group versus -0.41 (-0.74 to [-0.07]) % in controls (p = 0.021). In conclusion, a relatively short patient education program may have long-lasting effects on established modifiable markers of cardiovascular risk.",2020,The reduction in glycosylated hemoglobin was significant in both groups with a median absolute change of -0.29 (-1.11 to 0.09) % in the intervention group and -0.24,"['high risk coronary artery disease patients', 'Post-MI patients', 'One hundred ninety-eight consecutively randomized patients were included in the present substudy']","['8-week long educational program in addition to usual treatment and controls received standard treatment', 'Structured Adult Education Program']","['Low-density lipoprotein cholesterol, systolic blood pressure, body-mass index, and glycosylated hemoglobin', 'glycosylated hemoglobin', 'median change in body-mass index', 'median change in Low-density lipoprotein cholesterol', 'Cardiovascular Risk', 'Systolic blood pressure change']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856742', 'cui_str': 'Post MI'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0424936', 'cui_str': 'Adult education (finding)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",198.0,0.0813373,The reduction in glycosylated hemoglobin was significant in both groups with a median absolute change of -0.29 (-1.11 to 0.09) % in the intervention group and -0.24,"[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannopoulos', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece. Electronic address: ggiann@med.uoa.gr.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Karageorgiou', 'Affiliation': 'Second Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Vrachatis', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kousta', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Tsoukala', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Letsas', 'Affiliation': 'Second Department of Cardiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Siasos', 'Affiliation': 'First Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Deftereos', 'Affiliation': 'Second Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.12.033'] 3145,32015127,Parent coaching increases conversational turns and advances infant language development.,"Parental language input is one of the best predictors of children's language achievement. Parentese, a near-universal speaking style distinguished by higher pitch, slower tempo, and exaggerated intonation, has been documented in speech directed toward young children in many countries. Previous research shows that the use of parentese and parent-child turn-taking are both associated with advances in children's language learning. We conducted a randomized controlled trial to determine whether a parent coaching intervention delivered when the infants are 6, 10, and 14 mo of age can enhance parental language input and whether this, in turn, changes the trajectory of child language development between 6 and 18 mo of age. Families of typically developing 6-mo-old infants ( n = 71) were randomly assigned to intervention and control groups. Naturalistic first-person audio recordings of the infants' home language environment and vocalizations were recorded when the infants were 6, 10, 14, and 18 mo of age. After the 6-, 10-, and 14-mo recordings, intervention, but not control parents attended individual coaching appointments to receive linguistic feedback, listen to language input in their own recordings, and discuss age-appropriate activities that promote language growth. Intervention significantly enhanced parental use of parentese and parent-child turn-taking between 6 and 18 mo. Increases in both variables were significantly correlated with children's language growth during the same period, and children's language outcomes at 18 mo. Using parentese, a socially and linguistically enhanced speaking style, improves children's social language turn-taking and language skills. Research-based interventions targeting social aspects of parent-child interactions can enhance language outcomes.",2020,"Using parentese, a socially and linguistically enhanced speaking style, improves children's social language turn-taking and language skills.",['Families of typically developing 6-mo-old infants ( n = 71'],"['parent coaching intervention', 'individual coaching appointments to receive linguistic feedback, listen to language input in their own recordings, and discuss age-appropriate activities that promote language growth']","['conversational turns and advances infant language development', ""children's social language turn-taking and language skills"", 'parental use of parentese and parent-child turn-taking']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",71.0,0.0397048,"Using parentese, a socially and linguistically enhanced speaking style, improves children's social language turn-taking and language skills.","[{'ForeName': 'Naja', 'Initials': 'N', 'LastName': 'Ferjan Ramírez', 'Affiliation': 'Department of Linguistics, University of Washington, Seattle, WA 98195; naja@uw.edu pkkuhl@uw.edu.'}, {'ForeName': 'Sarah Roseberry', 'Initials': 'SR', 'LastName': 'Lytle', 'Affiliation': 'Institute for Learning & Brain Sciences, University of Washington, Seattle, WA 98195.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Kuhl', 'Affiliation': 'Institute for Learning & Brain Sciences, University of Washington, Seattle, WA 98195; naja@uw.edu pkkuhl@uw.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1921653117'] 3146,30882477,High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial.,"OBJECTIVES Assessing gas exchange, diaphragm function, respiratory rate, and patient comfort during high-flow oxygen therapy and standard oxygen at the time of noninvasive ventilation discontinuation. DESIGN Randomized crossover physiologic study. SETTING Two ICUs. PATIENTS Thirty chronic obstructive pulmonary disease patients with hypercapnic acute respiratory failure receiving noninvasive ventilation greater than 24 hours. INTERVENTIONS All patients underwent five 30-minute trials, the first, third, and fifth trial in noninvasive ventilation, whereas the second and fourth were randomly conducted with either standard oxygen and high-flow oxygen therapy. MEASUREMENTS AND MAIN RESULTS Diaphragm displacement and thickening fraction were determined by sonographic evaluation at the end of each trial. Arterial blood gases, respiratory rate, and patient comfort were also assessed. PaCO2 (p = 0.153) and pH (p = 0.114) were not different among trials, while PaO2 was greater in noninvasive ventilation than with both standard oxygen (p ≤ 0.005) and high-flow oxygen therapy (p ≤ 0.001). The diaphragm displacement was no different among trials (p = 0.875), while its thickening fraction was greater with standard oxygen, compared with high-flow oxygen therapy and all noninvasive ventilation trials (p < 0.001 for all comparisons), without differences between high-flow oxygen therapy and noninvasive ventilation. Respiratory rate also increased with standard oxygen, compared with both high-flow oxygen therapy (p < 0.001) and noninvasive ventilation (p < 0.01). High-flow oxygen therapy improved comfort, compared with standard oxygen (p = 0.004) and noninvasive ventilation (p < 0.001). CONCLUSIONS At the time of noninvasive ventilation interruption, PaCO2 and diaphragm displacement remained unchanged regardless of the modality of oxygen administration. However, although standard oxygen resulted in a remarkable increase in diaphragm thickening fraction, high-flow oxygen therapy allowed maintaining it unchanged, while improving patient comfort.",2019,"High-flow oxygen therapy improved comfort, compared with standard oxygen (p = 0.004) and noninvasive ventilation (p < 0.001). ","['Patients Recovering From Hypercapnic Acute Respiratory Failure', 'Thirty chronic obstructive pulmonary disease patients with hypercapnic acute respiratory failure receiving noninvasive ventilation greater than 24 hours']","['High-Flow Oxygen Therapy', 'Noninvasive Ventilation Interruption', 'standard oxygen and high-flow oxygen therapy']","['noninvasive ventilation interruption, PaCO2 and diaphragm displacement', 'PaCO2', 'Respiratory rate', 'Diaphragm displacement and thickening fraction', 'Arterial blood gases, respiratory rate, and patient comfort', 'gas exchange, diaphragm function, respiratory rate, and patient comfort', 'noninvasive ventilation', 'diaphragm displacement', 'diaphragm thickening fraction', 'thickening fraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0031843', 'cui_str': 'function'}]",30.0,0.220693,"High-flow oxygen therapy improved comfort, compared with standard oxygen (p = 0.004) and noninvasive ventilation (p < 0.001). ","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Longhini', 'Affiliation': ""Anesthesia and Intensive Care, Sant'Andrea Hospital, ASL VC, Vercelli, Italy.""}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pisani', 'Affiliation': 'Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital, Alma Mater University, Bologna, Italy.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Lungu', 'Affiliation': 'Anesthesia and Intensive Care, Maggiore della Carità Hospital, Novara, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Comellini', 'Affiliation': 'Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital, Alma Mater University, Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': 'Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Laura Vega', 'Affiliation': 'Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital, Alma Mater University, Bologna, Italy.'}, {'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'Anesthesia and Intensive Care, Maggiore della Carità Hospital, Novara, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nava', 'Affiliation': 'Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital, Alma Mater University, Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Navalesi', 'Affiliation': 'Intensive Care Unit, University Hospital Mater Domini, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000003740'] 3147,31402234,Randomized controlled trial to improve primary care follow-up among emergency department patients.,"STUDY OBJECTIVE Primary care (PC) follow-up for discharged emergency department (ED) patients provides patients with further medical attention. We conducted a pilot randomized controlled trial to determine whether using a freely-available physician appointment-booking website results in higher self-reported PC follow-up. METHODS We randomized discharged patients whom treating physicians determined PC follow-up was important and who possessed health insurance but had no PC provider to one of three groups: (1) a PC appointment booked through the booking website prior to ED discharge; (2) written information on how to use the booking website; or (3) usual care (i.e. standard follow-up instructions). We phoned subjects two weeks after the ED visit to determine whether they had completed a PC follow-up visit. We also asked subjects about their satisfaction with obtaining a PC appointment, satisfaction with the ED visit, symptom resolution and subsequent ED visits. The self-reported PCP follow-up rate was compared among the study groups by estimating the risk difference (RD) and 95% CI between usual care and each intervention group. RESULTS 272 subjects were enrolled and randomized and 68% completed the two-week telephone follow-up interview. The self-reported PCP follow-up rate was higher (52%) among subjects whose appointment was booked on the website before ED discharge (RD = 16%; 95% CI -1%, 34%) and lower (25%) for subjects who received booking website information (RD = 13%; 95% CI -32%, 7%) compared to subjects (36%) in the usual care group. A higher percentage of subjects in the booking group were more likely to report being extremely or very satisfied with obtaining a PC appointment (78%) compared to those who received booking website information (54%) or usual care (40%). CONCLUSION Among ED patients that providers judged PC follow-up is important, using a booking website to schedule an appointment before ED discharge resulted in a higher but not statistically significant self-reported PC follow-up rate. This intervention warrants further investigation in a study with a larger sample size and objective follow-up visit data.",2020,"The self-reported PCP follow-up rate was higher (52%) among subjects whose appointment was booked on the website before ED discharge (RD = 16%; 95% CI -1%, 34%) and lower (25%) for subjects who received booking website information (RD = 13%; 95% CI -32%, 7%) compared to subjects (36%) in the usual care group.","['Primary care (PC) follow-up for discharged emergency department (ED) patients provides patients with further medical attention', '272 subjects', 'patients whom treating physicians determined PC follow-up was important and who possessed health insurance but had no PC provider to one of three groups', 'emergency department patients']",[],['PCP follow-up rate'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",272.0,0.047437,"The self-reported PCP follow-up rate was higher (52%) among subjects whose appointment was booked on the website before ED discharge (RD = 16%; 95% CI -1%, 34%) and lower (25%) for subjects who received booking website information (RD = 13%; 95% CI -32%, 7%) compared to subjects (36%) in the usual care group.","[{'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'Merritt', 'Affiliation': 'Department of Emergency Medicine, Brown University, 55 Claverick Street, Providence, RI 02903, United States of America. Electronic address: Rory_Merritt@Brown.edu.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Kulie', 'Affiliation': 'Department of Emergency Medicine, George Washington University, Washington, DC, United States of America.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Long', 'Affiliation': 'Department of Emergency Medicine, George Washington University, Washington, DC, United States of America.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Choudhri', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'McCarthy', 'Affiliation': 'Department of Health Policy and Management, Department of Emergency Medicine, George Washington University, Washington, DC, United States of America.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158384'] 3148,31396398,Enhanced decision-making through multimodal training.,"A central aim of research in the psychological and decision sciences is to establish interventions that enhance performance, investigating the efficacy of modern approaches to improve human inference and decision-making. Whereas the decision sciences have established interventions to reduce decision biases by promoting strategies for critical thought and reasoning, methods from psychology have instead focused on enhancing cognition through skill-based training of executive functions. Contemporary research in psychology has engaged these operations through multi-modal interventions designed to enhance cognition and physical health through training of executive functions, mindfulness meditation, and physical fitness. Despite the comparable aims of research in the psychological and decision sciences, the efficacy of multi-modal interventions to enhance decision-making remain to be established. We therefore conducted a comprehensive, 16-week, randomized controlled trial (RCT) to investigate this issue, enrolling 160 healthy adults in one of four interventions: (1) high-intensity cardioresistance fitness training (HICRT); (2) HICRT and cognitive training of core executive functions; (3) HICRT and cognitive training, along with mindfulness meditation training; or (4) active control training. The results of our RCT demonstrate that HICRT training and multi-modal interventions that also incorporate cognitive training and mindfulness meditation have beneficial effects on decision-making competence. The observed pattern of findings motivate the application of modern interventions from psychology and cognitive neuroscience to enhance human judgment and decision-making in complex, real-world environments.",2019,"Whereas the decision sciences have established interventions to reduce decision biases by promoting strategies for critical thought and reasoning, methods from psychology have instead focused on enhancing cognition through skill-based training of executive functions.",['160 healthy adults in one of four interventions: (1'],"['high-intensity cardioresistance fitness training (HICRT); (2) HICRT and cognitive training of core executive functions; (3) HICRT and cognitive training, along with mindfulness meditation training; or (4) active control training']",[],"[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],160.0,0.0127373,"Whereas the decision sciences have established interventions to reduce decision biases by promoting strategies for critical thought and reasoning, methods from psychology have instead focused on enhancing cognition through skill-based training of executive functions.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Zwilling', 'Affiliation': '1Decision Neuroscience Laboratory, University of Illinois, Urbana, IL USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Daugherty', 'Affiliation': '1Decision Neuroscience Laboratory, University of Illinois, Urbana, IL USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': '4Department of Psychology, Northeastern University, Boston, MA USA.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': '4Department of Psychology, Northeastern University, Boston, MA USA.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Cohen', 'Affiliation': '2Beckman Institute for Advanced Science and Technology, University of Illinois, Urbana, IL USA.'}, {'ForeName': 'Aron K', 'Initials': 'AK', 'LastName': 'Barbey', 'Affiliation': '1Decision Neuroscience Laboratory, University of Illinois, Urbana, IL USA.'}]",NPJ science of learning,['10.1038/s41539-019-0049-x'] 3149,32113628,Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes With Laboratory Confirmation.,"OBJECTIVES There are no approved vaccines for respiratory syncytial virus (RSV), and consensus on methods to assess RSV vaccine efficacy has not been established. In this study of an adjuvanted RSV vaccine, we evaluated an RSV disease endpoint using a patient-reported outcome instrument (the inFLUenza Patient-Reported Outcome instrument [FLU-PRO]) and molecular testing for virologic confirmation. METHODS In a randomized, blinded efficacy study (NCT02508194), 1900 adult participants aged ≥60 years who had any respiratory symptom lasting ≥24 hours recorded symptoms in a FLU-PRO-based workbook for 21 days, self-collected nasal swabs on illness days 2 to 4, and had a site-collected swab obtained on (approximately) day 4. The endpoint, acute RSV-associated respiratory illness (ARA-RI), required specific symptoms with virologic confirmation. RESULTS The FLU-PRO demonstrated reliability, ability to detect change, and validity and had high participant adherence and acceptable patient burden in the setting of an RSV prevention trial. The ARA-RI endpoint definition captured all 33 virologically confirmed RSV illnesses for which symptom data were provided, and in 32 of these, at least 1 lower respiratory symptom was reported. Sensitivity analysis with an endpoint requiring ≥2 lower respiratory symptoms captured greater symptom severity but fewer cases. Results of self- and site-collected swabs were highly correlated. Self-swabbing detected 9 additional cases that would have been missed by site swabbing only. CONCLUSIONS These results demonstrated the reliability and validity of the ARA-RI definition and of the FLU-PRO for use in RSV studies. Self-swabbing improved RSV detection.",2020,"The FLU-PRO demonstrated reliability, ability to detect change, and validity and had high participant adherence and acceptable patient burden in the setting of an RSV prevention trial.","['Older Adults', '1900 adult participants aged ≥60 years who had any respiratory symptom lasting ≥24 hours recorded symptoms in a FLU-PRO-based workbook for 21 days, self-collected nasal swabs on illness days 2 to 4, and had a site-collected swab obtained on (approximately) day 4']","['adjuvanted RSV vaccine', 'Respiratory Syncytial Virus Vaccine']","['acute RSV-associated respiratory illness (ARA-RI), required specific symptoms with virologic confirmation', 'RSV vaccine efficacy', 'Self-swabbing improved RSV detection']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0242806', 'cui_str': 'Sick Days'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]",1900.0,0.09763,"The FLU-PRO demonstrated reliability, ability to detect change, and validity and had high participant adherence and acceptable patient burden in the setting of an RSV prevention trial.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Clinical Biostatistics, Infectious Diseases and Vaccines, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, George Washington University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vallo', 'Affiliation': 'Clinical Development, Infectious Diseases and Vaccines, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Falloon', 'Affiliation': 'Clinical Development, Infectious Diseases and Vaccines, AstraZeneca, Gaithersburg, MD, USA. Electronic address: FalloonJ@VielaBio.com.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.09.2747'] 3150,32115325,"The Youth Aware of Mental Health Intervention: Impact on Help Seeking, Mental Health Knowledge, and Stigma in U.S. Adolescents.","PURPOSE Suicide is a leading cause of death among U.S. youth aged 12-18 years. Youth Aware of Mental Health (YAM), a promising, universal, school-based mental health promotion/suicide primary prevention intervention for adolescents, has been evaluated in Europe but not in the U.S. The present study used an uncontrolled, pretest/post-test design to document the potential for YAM to reduce suicidal ideation, attempt, and suicide. A demonstration that help seeking behaviors, mental health literacy, and mental health stigmatizing attitudes improve after the intervention would suggest that the program is promising in the U.S., as well as in Europe, and that further investigation is merited. METHODS YAM was delivered to 1,878 students in 11 schools as part of regular school curricula. A subset of these students (n = 436) completed surveys before and 3 months postdelivery. Surveys included five questions about help seeking behaviors, a measure of intent to seek help (General Help Seeking Questionnaire), two mental health literacy scales, and two mental illness stigma scales (Reported and Intended Behavior Scale and Personal Stigma and Social Distance Scale). Both McNemar's test and repeated measures linear models were used to determine whether the survey outcomes changed after YAM delivery. RESULTS Among the 436 adolescents (286 and 150 in Montana and Texas, respectively), significant increases were found pre- to post-intervention in three of five help seeking behaviors, along with improved mental health literacy and decreased mental health-related stigma. Intent to seek help was unchanged. CONCLUSIONS Several help seeking behavioral factors, mental health knowledge, and stigma improved post-YAM intervention. All three domains are likely protective against suicide. A randomized controlled trial testing the efficacy of YAM in preventing suicidal behaviors is warranted.",2020,"to post-intervention in three of five help seeking behaviors, along with improved mental health literacy and decreased mental health-related stigma.","['U.S. youth aged 12-18\xa0years', '1,878 students in 11 schools as part of regular school curricula', '436 adolescents (286 and 150 in Montana and Texas, respectively']",['YAM'],"['mental health literacy and decreased mental health-related stigma', 'seeking behaviors, a measure of intent to seek help (General Help Seeking Questionnaire), two mental health literacy scales, and two mental illness stigma scales ', 'Intended Behavior Scale and Personal Stigma and Social Distance Scale']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0026506', 'cui_str': 'Montana'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0936043', 'cui_str': 'Dioscorea'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}]",,0.0482124,"to post-intervention in three of five help seeking behaviors, along with improved mental health literacy and decreased mental health-related stigma.","[{'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Lindow', 'Affiliation': 'Department of Cell Biology and Neuroscience, Center for Mental Health Research and Recovery, Montana State University, Bozeman, Montana. Electronic address: jlindow@email.arizona.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'South', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Clinical Science, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bannister', 'Affiliation': 'Department of Cell Biology and Neuroscience, Center for Mental Health Research and Recovery, Montana State University, Bozeman, Montana.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Byerly', 'Affiliation': 'Department of Cell Biology and Neuroscience, Center for Mental Health Research and Recovery, Montana State University, Bozeman, Montana.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.01.006'] 3151,31262319,Time-dependent tuning of balance control and aftereffects following optical flow perturbation training in older adults.,"BACKGROUND Walking balance in older adults is disproportionately susceptible to lateral instability provoked by optical flow perturbations. The prolonged exposure to these perturbations could promote reactive balance control and increased balance confidence in older adults, but this scientific premise has yet to be investigated. This proof of concept study was designed to investigate the propensity for time-dependent tuning of walking balance control and the presence of aftereffects in older adults following a single session of optical flow perturbation training. METHODS Thirteen older adults participated in a randomized, crossover design performed on different days that included 10 min of treadmill walking with (experimental session) and without (control session) optical flow perturbations. We used electromyographic recordings of leg muscle activity and 3D motion capture to quantify foot placement kinematics, lateral margin of stability, and antagonist coactivation during normal walking (baseline), early (min 1) and late (min 10) responses to perturbations, and aftereffects immediately following perturbation cessation (post). RESULTS At their onset, perturbations elicited 17% wider and 7% shorter steps, higher step width and length variability (+171% and +132%, respectively), larger and more variable margins of stability (MoS), and roughly twice the antagonist leg muscle coactivation (p-values<0.05). Despite continued perturbations, most outcomes returned to values observed during normal, unperturbed walking by the end of prolonged exposure. After 10 min of perturbation training and their subsequent cessation, older adults walked with longer and more narrow steps, modest increases in foot placement variability, and roughly half the MoS variability and antagonist lower leg muscle coactivation as they did before training. CONCLUSIONS Findings suggest that older adults: (i) respond to the onset of perturbations using generalized anticipatory balance control, (ii) deprioritize that strategy following prolonged exposure to perturbations, and (iii) upon removal of perturbations, exhibit short-term aftereffects that indicate a lessening of anticipatory control, an increase in reactive control, and/or increased balance confidence. We consider this an early, proof-of-concept study into the clinical utility of prolonged exposure to optical flow perturbations as a training tool for corrective motor adjustments relevant to walking balance integrity toward reinforcing task-specific, reactive control and/or improving balance confidence in older adults. TRIAL REGISTRATION clinicaltrials.gov ( NCT03341728 ). Registered 14 November 2017.",2019,"Despite continued perturbations, most outcomes returned to values observed during normal, unperturbed walking by the end of prolonged exposure.","['Thirteen older adults', 'older adults']","['optical flow perturbation training', 'treadmill walking with (experimental session) and without (control session) optical flow perturbations']","['step width and length variability', 'variable margins of stability (MoS), and roughly twice the antagonist leg muscle coactivation', 'leg muscle activity and 3D motion capture to quantify foot placement kinematics, lateral margin of stability, and antagonist coactivation during normal walking (baseline), early (min 1) and late (min 10) responses to perturbations, and aftereffects', 'foot placement variability, and roughly half the MoS variability and antagonist lower leg muscle coactivation', 'balance confidence']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",13.0,0.0428492,"Despite continued perturbations, most outcomes returned to values observed during normal, unperturbed walking by the end of prolonged exposure.","[{'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Richards', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, 10206C Mary Ellen Jones Building, CB 7575, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Selgrade', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, 10206C Mary Ellen Jones Building, CB 7575, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Qiao', 'Affiliation': 'Department of Kinesiology, Louisiana Tech University, Ruston, LA, USA.'}, {'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Division of Physical Therapy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Franz', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, 10206C Mary Ellen Jones Building, CB 7575, Chapel Hill, NC, 27599, USA. jrfranz@email.unc.edu.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0555-3'] 3152,31932108,"Pazopanib and Fosbretabulin in recurrent ovarian cancer (PAZOFOS): A multi-centre, phase 1b and open-label, randomised phase 2 trial.","OBJECTIVE Vascular co-option is a resistance mechanism to anti-angiogenic agents, but combinations of anti-vascular agents may overcome this resistance. We report a phase 1b and randomised phase 2 trial to determine the safety and efficacy of pazopanib with fosbretabulin. METHODS Eligible patients had recurrent, epithelial ovarian cancer with a platinum-free interval (PFI) of 3 to 12 months. Patients were stratified according to PFI (>6 versus ≤6 months) and prior bevacizumab use. RESULTS Twelve patients were treated in the phase 1b. Commonest grade ≥ 2 adverse events (AEs) were hypertension (100%), neutropenia (50%), fatigue (50%), vomiting (50%). There was one DLT (grade 3 fatigue). The recommended phase 2 dose level was fosbretabulin 54 mg/m 2 on days 1, 8 and 15 and pazopanib 600 mg once daily (od), every 28 days, which was then compared to pazopanib 800 mg od in a randomised phase 2 trial. Twenty-one patients were randomised (1:1) in the phase 2 trial. In phase 1b and phase 2, four patients treated with pazopanib and fosbretabulin developed reversible, treatment-related cardiac AEs, leading to premature discontinuation of the study. In the phase 2 trial, the median PFS was 7.6 months (95% CI 4.1-not estimated) versus 3.7 months (95% CI 1.0-8.1) in favour of the experimental arm (HR 0.30, 95% CI 0.09-1.03, P = .06). CONCLUSIONS It remains unclear whether pazopanib with with fosbretabulin is an efficacious regimen to treat epithelial ovarian cancer. Effective cardiac risk mitigation is needed to increase the tolerability and maximize patient safety in future trials.",2020,"In the phase 2 trial, the median PFS was 7.6 months (95% CI 4.1-not estimated) versus 3.7 months (95% CI 1.0-8.1) in favour of the experimental arm (HR 0.30, 95% CI 0.09-1.03, P = .06). ","['Twelve patients were treated in the phase 1b', 'Eligible patients had recurrent, epithelial ovarian cancer with a platinum-free interval (PFI) of 3 to 12\xa0months', 'recurrent ovarian cancer (PAZOFOS']","['Pazopanib and Fosbretabulin', 'pazopanib', 'bevacizumab']","['vomiting', 'Commonest grade\xa0≥', 'safety and efficacy', 'median PFS', 'neutropenia', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0056154', 'cui_str': '2-methoxy-5-((z)-2-(3,4,5-trimethoxyphenyl)vinyl)phenyl dihydrogen phosphate'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.212871,"In the phase 2 trial, the median PFS was 7.6 months (95% CI 4.1-not estimated) versus 3.7 months (95% CI 1.0-8.1) in favour of the experimental arm (HR 0.30, 95% CI 0.09-1.03, P = .06). ","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Morgan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Jurjees', 'Initials': 'J', 'LastName': 'Hasan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Orbegoso', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Tugwood', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust, London, UK; Faculty of Medicine, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dive', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Gordon J S', 'Initials': 'GJS', 'LastName': 'Rustin', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Gordon C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. Electronic address: Gordon.Jayson@christie.nhs.uk.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.01.005'] 3153,31937450,Intraperitoneal chemotherapy following neoadjuvant chemotherapy and optimal interval tumor reductive surgery for advanced ovarian cancer.,"OBJECTIVES Intraperitoneal (IP) chemotherapy following neoadjuvant chemotherapy (NACT) and interval tumor reductive surgery (TRS) for advanced ovarian cancer is feasible, however, the impact on disease outcomes remains unclear. We compare outcomes of patients treated with IP chemotherapy versus intravenous (IV) chemotherapy following NACT and interval TRS. METHODS In this retrospective review, patients with advanced ovarian cancer were included if they received NACT followed by optimal interval TRS between 1/2004 and 4/2017. Patients were excluded if they had an ECOG PS >1, received >6 cycles of NACT or postoperative chemotherapy, and/or received bevacizumab during primary therapy. Primary outcomes were progression free survival (PFS) and overall survival (OS). RESULTS There were 134 patients included in this study, 37 (28%) received IP and 97 (72%) received IV chemotherapy postoperatively. Patients in the IV group were older (median 66.3 vs 59.7 years, p = 0.0039) though there were no differences in BMI, race, BRCA status, stage, or histology. Median PFS was 3 months longer in the IP group (14.5 versus 11.5 months, p = 0.028) however there was no significant difference in OS. On univariate analysis, increasing number of NACT cycles (HR 1.914, 95% CI 1.024-3.497) and residual disease at completion of TRS (HR 1.541, 95% CI 1.042-2.248) were associated with decreased PFS; IP chemotherapy was associated with increased PFS (HR 0.633, 95% CI 0.414-0.944). These associations remained on multivariate analysis. Toxicity was comparable between the groups. CONCLUSIONS IP after NACT and optimal interval TRS was associated with in improved PFS compared to IV chemotherapy without significant differences in toxicity.",2020,"Median PFS was 3 months longer in the IP group (14.5 versus 11.5 months, p = 0.028) however there was no significant difference in OS.","['advanced ovarian cancer', '134 patients included in this study, 37 (28%) received IP and 97 (72%) received', 'Patients were excluded if they had an ECOG PS >1, received >6\xa0cycles of', 'patients with advanced ovarian cancer']","['IV chemotherapy postoperatively', 'neoadjuvant chemotherapy and optimal interval tumor reductive surgery', 'NACT', 'NACT or postoperative chemotherapy, and/or received bevacizumab', 'IP chemotherapy versus intravenous (IV) chemotherapy following NACT and interval TRS', 'Intraperitoneal chemotherapy', 'Intraperitoneal (IP) chemotherapy', 'neoadjuvant chemotherapy (NACT) and interval tumor reductive surgery (TRS']","['BMI, race, BRCA status, stage, or histology', 'PFS', 'toxicity', 'progression free survival (PFS) and overall survival (OS', 'residual disease at completion of TRS', 'Toxicity', 'OS', 'number of NACT cycles', 'Median PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0413365', 'cui_str': 'Intravenous chemotherapy (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}]","[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",134.0,0.48473,"Median PFS was 3 months longer in the IP group (14.5 versus 11.5 months, p = 0.028) however there was no significant difference in OS.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bixel', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America. Electronic address: Kristin.bixel@osumc.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vetter', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States of America; Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berchuck', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States of America; Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cohn', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Copeland', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Fowler', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Havrilesky', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States of America; Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Lee', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States of America; Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Valea', 'Affiliation': 'Division of Gynecologic Oncology, Virginia Tech Carilion School of Medicine, Roanoke, VA, United States of America.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States of America; Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Backes', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America; The Ohio State University Comprehensive Cancer Center, Arthur G James Cancer Hospital and Richard J Solove Research institute, Columbus, OH, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.12.016'] 3154,32037213,The James A. Rand Young Investigator's Award: Traditional Intravenous Fluid vs. Oral Fluid Administration in Primary Total Knee Arthroplasty: A Randomized Trial.,"BACKGROUND Optimal perioperative fluid management has not been established in patients undergoing orthopedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management (ie, preoperative, intraoperative, and postoperative) on patients undergoing total knee arthroplasty (TKA). METHODS One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs oral (OFG) perioperative fluid management groups. The primary outcome was change in body weight (BW). Secondary outcome measures included knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, Knee injury and Osteoarthritis Outcome Score JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events. RESULTS The TFG had increased BW the evening of surgery (7.0 ± 4.3 vs 3.0 ± 3.9, P < .0001), postoperative day (POD) #1 (9.1 ± 4.3 vs 4.7 ± 3.9, P < .0001), and POD #2 (6.2 ± 5.0 vs 4.4 ± 4.0, P = .032). Bioelectrical impedance showed less limb edema in the OFG (4.2 ± 29.7 vs 17.8 ± 30.3, P < .0001) on POD #1. Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002). Systolic blood pressure decrease from the baseline was greater in the OFG on arrival to the floor (19.4 ± 13.5 vs 10.6 ± 12.8, P < .0001) and 8 (23.4 ± 13.3 vs 17.0 ± 12.9, P = .006) and 16 (25.8 ± 13.8 vs 25.8 ± 13.8, P = .046) hours after floor arrival. The TFG had more urine output on POD #1 (3369 mL ± 1343 mL vs 2435 mL ± 1151 mL, P < .0001). The OFG were more likely to go home on POD #1 than the TFG (63 vs 56, P = .02). CONCLUSION Oral fluid intake with IVF restriction in the perioperative period after TKA may offer short-term benefits with swelling and BW fluctuations. The authors continue to limit perioperative IVFs and encourage patient initiated fluid intake.",2020,"Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002).","['patients undergoing total knee arthroplasty (TKA', 'One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA', 'patients undergoing orthopedic surgical procedures', 'Primary Total Knee Arthroplasty']","['traditional (TFG) vs oral (OFG) perioperative fluid management groups', 'Traditional Intravenous Fluid Versus Oral Fluid Administration', 'TFG', 'perioperative fluid management (ie, preoperative, intraoperative, and postoperative']","['knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, Knee injury and Osteoarthritis Outcome Score JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events', 'Systolic blood pressure decrease', 'limb edema', 'Urine specific gravity differences', 'postoperative day (POD', 'change in body weight (BW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1136201', 'cui_str': 'Orthopedic Surgical Procedures'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518766'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0587361', 'cui_str': 'Specific gravity of urine (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",130.0,0.196637,"Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002).","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Jennings', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO; Department of Mechanical and Materials Engineering, University of Denver, Denver, CO.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Mejia', 'Affiliation': 'US Anesthesia Partners, Denver, CO.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Williams', 'Affiliation': 'Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Roseann M', 'Initials': 'RM', 'LastName': 'Johnson', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Charlie C', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Dennis', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO; Department of Mechanical and Materials Engineering, University of Denver, Denver, CO; Department of Orthopaedics, University of Colorado School of Medicine, Denver, CO; Department of Biomedical Engineering, University of Tennessee, Knoxville, TN.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.01.029'] 3155,31786338,"An exploratory randomized sub-study of light-to-moderate intensity exercise on cognitive function, depression symptoms and inflammation in older adults with heart failure.","OBJECTIVE Almost half of patients with heart failure (HF) have cognitive impairment. While exercise relates to better cognitive health, a hallmark of HF is exercise intolerance. The study objective was to explore whether light-to-moderate exercise improves cognitive function in patients with HF. METHODS This was an exploratory parallel design study of 69 patients with symptomatic HF (mean age = 65, SD = 10), recruited from VA and University of California, San Diego Healthcare Systems. Participants were randomized to Tai Chi (TC) (n = 24), resistance band (RB) exercise (n = 22) or treatment as usual (TAU) (n = 23). The primary outcome was change in Montreal Cognitive Assessment (MoCA) scores. We further explored if changes in Beck Depression Inventory - IA (BDI-IA) scores or inflammation biomarkers, CRP, TNFα and IL-6 related to altered cognitive function. RESULTS There was a fixed effect of group for MoCA scores changes (F = 8.07, p = .001). TC and RB groups had greater MoCA score increases versus TAU, but no differences were found between TC and RB. Depression symptom changes predicted altered MoCA scores (ΔR 2  = 0.15, Β = -0.413, p = .001). However, group did not interact with depression symptom levels for MoCA alterations (p = .392). Changes in CRP levels predicted MoCA scores (ΔR 2  = 0.078, Β = -0.283, p = .01), but group did not interact with CRP levels for MoCA alterations (p = .689). CONCLUSIONS Light-to-moderate exercises, TC and RB may improve cognitive function. However, the mechanisms remain unclear. ClinicalTrials.gov: NCT01625819.",2020,"There was a fixed effect of group for MoCA scores changes (F = 8.07, p = .001).","['patients with heart failure (HF', 'older adults with heart failure', 'patients with HF', '69 patients with symptomatic HF']","['TC and RB', 'resistance band (RB) exercise (n\xa0=\xa022) or treatment as usual (TAU) ', 'light-to-moderate exercise', 'light-to-moderate intensity exercise', 'Tai Chi (TC']","['MoCA score', 'MoCA scores changes', 'Changes in CRP levels predicted MoCA scores', 'cognitive function', 'MoCA scores', 'cognitive function, depression symptoms and inflammation', 'Beck Depression Inventory - IA (BDI-IA) scores or inflammation biomarkers, CRP, TNFα and IL-6', 'Montreal Cognitive Assessment (MoCA) scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",69.0,0.064532,"There was a fixed effect of group for MoCA scores changes (F = 8.07, p = .001).","[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Redwine', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA; College of Nursing, University of South Florida, Tampa, FL, USA. Electronic address: lredwine@usf.edu.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Pung', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, CA, USA; College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, CA, USA.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Bangen', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Delano-Wood', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hurwitz', 'Affiliation': 'Psychology Department, University of Miami, USA.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109883'] 3156,32114641,Diets naturally rich in polyphenols and/or long-chain n-3 polyunsaturated fatty acids differently affect microbiota composition in high-cardiometabolic-risk individuals.,"AIMS Gut microbiota significantly impacts human health and is influenced by dietary changes. We evaluated the effects of diets naturally rich in polyphenols (PP) and/or long-chain n-3 polyunsaturated fatty acids (LCn3) on microbiota composition in an ancillary analysis of a randomized controlled trial in individuals at high cardiometabolic risk. METHODS Seventy-eight individuals with high waist circumference and at least one additional component of the metabolic syndrome were randomized to an isoenergetic 8-week diet: (a) low LCn3 and PP; (b) high LCn3; (c) high PP; or (d) high LCn3 and PP. Microbiota analysis was performed on feces collected before and after the intervention. DGGE analysis of the predominant bacteria, Eubacterium rectale and Blautia coccoides group (Lachnospiraceae, EREC), Clostridium leptum (Ruminococcaceae, CLEPT), Bacteroides spp., Bifidobacteria, and Lactobacillus group was performed. A quantitative real-time PCR was performed for the same group, additionally including Atopobium cluster (Coriobatteriaceae). Before and after the intervention, participants underwent a 75 g OGTT and a high-fat test meal to evaluate glucose and lipid response. RESULTS Adherence to the four diets was optimal. PP significantly increased microbial diversity (p = 0.006) and CLEPT (p = 0.015), while it reduced EREC (p = 0.044). LCn3 significantly increased the numbers of Bifidobacteria (p = 0.041). Changes in CLEPT numbers correlated with changes in early insulin secretion (r = 0.263, p = 0.030). Changes in Atopobium numbers correlated with postprandial triglycerides in plasma (r = 0.266, p = 0.026) and large VLDL (r = 0.313, p = 0.009), and cholesterol in large VLDL (r = 0.319, p = 0.008). CONCLUSIONS Diets naturally rich in PP or LCn3 influenced gut microbiota composition in individuals at high cardiometabolic risk. These modifications were associated with changes in glucose/lipid metabolism.",2020,"PP significantly increased microbial diversity (p = 0.006) and CLEPT (p = 0.015), while it reduced EREC (p = 0.044).","['Seventy-eight individuals with high waist circumference and at least one additional component of the metabolic syndrome', 'individuals at high cardiometabolic risk', 'high-cardiometabolic-risk individuals']","['isoenergetic 8-week diet: (a) low LCn3 and PP; (b) high LCn3; (c) high PP; or (d) high LCn3 and PP', 'Diets naturally rich in polyphenols and/or long-chain n-3 polyunsaturated fatty acids', 'LCn3', 'diets naturally rich in polyphenols (PP) and/or long-chain n-3 polyunsaturated fatty acids (LCn3']","['numbers of Bifidobacteria', 'gut microbiota composition', 'cholesterol in large VLDL', 'early insulin secretion', 'postprandial triglycerides in plasma', 'microbial diversity', 'glucose/lipid metabolism', 'large VLDL']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",78.0,0.0267186,"PP significantly increased microbial diversity (p = 0.006) and CLEPT (p = 0.015), while it reduced EREC (p = 0.044).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Maukonen', 'Affiliation': 'VTT Technical Research Centre of Finland, Espoo, Finland.'}, {'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Costabile', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy. rivelles@unina.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saarela', 'Affiliation': 'VTT Technical Research Centre of Finland, Espoo, Finland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples ""Federico II"", 5, Sergio Pansini, 80131, Naples, Italy.'}]",Acta diabetologica,['10.1007/s00592-020-01494-9'] 3157,32111517,Shorter corridors can be used for the six-minute walk test in subjects with chronic lung diseases.,"BACKGROUND The main limitation of the six-minute walk test (6-MWT) is that not all pulmonary function testing facilities have an indoor flat, 30-m-long corridor. Therefore, this study aimed 1) to evaluate the correlation and agreement of the distances walked in 30-m- vs. 15-m-long corridors by subjects with chronic lung diseases (CLD group) and 2) to compare the levels of oxygen saturation (nSpO 2 ), blood pressure (BP), heart rate recovery at minute one post-exercise (HRR1), and Borg scale scores for dyspnea and fatigue between the two distances walked. METHODS A prospective, cross-sectional study was conducted at the National Institute of Respiratory Diseases in Mexico City. Subjects with chronic lung diseases and healthy adults were invited to participate. The distance of the 6-MWT was randomly assigned based on whether the first test was in the 15-m or 30-m corridor. RESULTS Ninety individuals were included; the correlation in meters walked between the two corridors was r = 0.96 in CLD; the 95% limits of agreement for the 6-MWT ranged from -73 to +37 m. Most subjects walked further in the 30-m corridor (82%); however, the percent predicted values for the CLD group were 3.5% lower for the 15-m corridor than the 30-m corridor. Only 10.5% of the subjects with CLD would have been falsely classified as having a normal 6-MWT (false negative). No significant differences in the nSpO2, Borg scale, BP or HRR1 were found between the two 6-MWT corridor lengths. CONCLUSION The 6-MWT can be performed using a 15-m corridor in subjects with CLD, and the results for the distance walked, HRR1, nSpO 2 , and Borg scale scores are similar to between the 15-m and 30-m corridors.",2020,"No significant differences in the nSpO2, Borg scale, BP or HRR1 were found between the two 6-MWT corridor lengths. ","['Ninety individuals were included; the correlation in meters walked between the two corridors was', 'subjects with chronic lung diseases (CLD group) and 2', 'A prospective, cross-sectional study was conducted at the National Institute of Respiratory Diseases in Mexico City', 'subjects with chronic lung diseases', 'Subjects with chronic lung diseases and healthy adults']",['6-MWT'],"['levels of oxygen saturation (nSpO 2 ), blood pressure (BP), heart rate recovery at minute one post-exercise (HRR1), and Borg scale scores for dyspnea and fatigue', 'nSpO2, Borg scale, BP or HRR1']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0557670', 'cui_str': 'Corridor (environment)'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0055926', 'cui_str': 'endogenous clonidine-like substance'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",90.0,0.0346944,"No significant differences in the nSpO2, Borg scale, BP or HRR1 were found between the two 6-MWT corridor lengths. ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gochicoa-Rangel', 'Affiliation': 'Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosío Villegas"", Tlalpan 4502, Sección XXI, Alcaldía Tlalpan, Ciudad de México, 14080, Mexico; Laboratorio de Función Pulmonar, Insituto de Desarrollo e Innovación en Fisiología Respiratoria S. de R.L, Av. Baja California 67-301, Romar Sur, Alcaldia Cuauhtémoc, Ciudad de México, 06760, Mexico. Electronic address: laura.gochicoa@infire.mx.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Ramírez-José', 'Affiliation': 'Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosío Villegas"", Tlalpan 4502, Sección XXI, Alcaldía Tlalpan, Ciudad de México, 14080, Mexico.'}, {'ForeName': 'Prysila', 'Initials': 'P', 'LastName': 'Troncoso-Huitrón', 'Affiliation': 'Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosío Villegas"", Tlalpan 4502, Sección XXI, Alcaldía Tlalpan, Ciudad de México, 14080, Mexico.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Silva-Cerón', 'Affiliation': 'Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosío Villegas"", Tlalpan 4502, Sección XXI, Alcaldía Tlalpan, Ciudad de México, 14080, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guzmán-Valderrábano', 'Affiliation': 'Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosío Villegas"", Tlalpan 4502, Sección XXI, Alcaldía Tlalpan, Ciudad de México, 14080, Mexico.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Lechuga-Trejo', 'Affiliation': 'Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosío Villegas"", Tlalpan 4502, Sección XXI, Alcaldía Tlalpan, Ciudad de México, 14080, Mexico.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cid-Juárez', 'Affiliation': 'Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias ""Ismael Cosío Villegas"", Tlalpan 4502, Sección XXI, Alcaldía Tlalpan, Ciudad de México, 14080, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Torre-Bouscoulet', 'Affiliation': 'Laboratorio de Función Pulmonar, Insituto de Desarrollo e Innovación en Fisiología Respiratoria S. de R.L, Av. Baja California 67-301, Romar Sur, Alcaldia Cuauhtémoc, Ciudad de México, 06760, Mexico. Electronic address: luis.torre@infire.mx.'}]",Respiratory investigation,['10.1016/j.resinv.2019.12.009'] 3158,32112181,Effect of amlodipine on blood flow of preovulatory follicle in women with clomiphene resistant polycystic ovaries: a randomized controlled trial.,"OBJECTIVE To detect whether amlodipine could increase pre-ovulatory follicular blood flow, thus enhancing ovulation and creating a better chance of conception in women with PCOS. METHODS 165 women were screened of which 124 were qualified and women were equally randomized to 62 receiving clomiphene citrate and amlodipine and 62 receiving clomiphene citrate and placebo. The primary outcome was to detect if amlodipine can improve pre-ovulatory follicle blood flow studied by colour and power Doppler Pulsatility index of ovarian arteries, with drug administration. The secondary outcomes were endometrial thickness and clinical pregnancy. RESULTS The mean value of the ovarian arteries Pulsatility Index was significantly lower in the amlodipine group when compared to those of the placebo group (1.36 and 1.82, respectively, with P value 0.002). Mean endometrial thickness, for all women in both groups, on the day of detecting a mature follicle was significantly higher in the amlodipine group compared to the placebo group (8.99 and 7.0, respectively, with P value 0.003), and clinical pregnancy increased from 11% to 37% in the amlodipine group compared to the placebo group. CONCLUSION Amlodipine improves ovarian blood flow and increases the chances of conception. TRIAL REGISTRATION Pan African Clinical Trial Registry (http://www.pactr.org). Trial No: PAC TR201708002485292.",2020,"The mean value of the ovarian arteries Pulsatility Index was significantly lower in the amlodipine group when compared to those of the placebo group (1.36 and 1.82, respectively, with P value 0.002).","['165 women were screened of which 124 were qualified and women', 'women with PCOS', 'women with clomiphene resistant polycystic ovaries']","['clomiphene citrate and placebo', 'clomiphene citrate and amlodipine', 'placebo', 'Amlodipine', 'amlodipine']","['endometrial thickness and clinical pregnancy', 'pre-ovulatory follicle blood flow studied by colour and power Doppler Pulsatility index of ovarian arteries, with drug administration', 'mean value of the ovarian arteries Pulsatility Index', 'clinical pregnancy', 'ovarian blood flow', 'Mean endometrial thickness', 'blood flow of preovulatory follicle', 'pre-ovulatory follicular blood flow', 'chances of conception']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0226411', 'cui_str': 'Structure of ovarian artery'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]",165.0,0.3901,"The mean value of the ovarian arteries Pulsatility Index was significantly lower in the amlodipine group when compared to those of the placebo group (1.36 and 1.82, respectively, with P value 0.002).","[{'ForeName': 'Haitham A', 'Initials': 'HA', 'LastName': 'Torky', 'Affiliation': 'Obstetrics and Gynecology Department, October 6th University and Air-Force Specialized Hospital, New Cairo, Egypt. haithamtorky@yahoo.com.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Shata', 'Affiliation': 'Obstetrics and Gynecology Department, Matariya Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Ahmad', 'Affiliation': 'Obstetrics and Gynecology Department, Al-Galaa Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ragab', 'Affiliation': 'Obstetrics and Gynecology Department, Al-Galaa Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abo-Louz', 'Affiliation': 'Obstetrics and Gynecology Department, October 6th University and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hussein', 'Affiliation': 'Obstetrics and Gynecology Department, October 6th University and Air-Force Specialized Hospital, New Cairo, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Aly', 'Affiliation': 'Obstetrics and Gynecology Department, Al-Galaa Teaching Hospital and Air-Force Specialized Hospital, New Cairo, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05471-z'] 3159,31392719,Educating parents to improve parent-child interactions: Fostering the development of attentional control and executive functioning.,"BACKGROUND Parent-child interaction is essential in the development of attentional control (AC) and executive functioning (EF). Educating parents in AC and EF development may help them to respond more adaptively to their child's developmental needs. AIM This study aimed to investigate whether parents can be educated to improve interactions with their child through a compact psycho-educational programme that focuses on fostering the development of AC and EF. SAMPLE Parents and their children in a low-risk sample of four- to eight-year-olds were randomly assigned to either the educational programme condition (N = 34) or the control condition (N = 36). METHODS Parental supportive presence and intrusiveness were observed during home visits, and children's performance-based AC and EF were assessed before and after the four-session programme. RESULT Parents in the educational programme improved significantly in support ( η p 2  = .19) and intrusiveness ( η p 2  = .09) compared to controls. There was no short-term programme mediation effect on child AC and EF through parental support and intrusiveness. This study showed, however, that parents who improved after the educational programme had children who improved on AC and EF. CONCLUSION Parent-child interaction can be enhanced in a low-risk sample of four- to eight-year-olds using a compact educational group programme within the school community. Future studies should aim at examining variations in programme responsiveness and assessing associations between parent-child interaction and AC and EF over time.",2020,Parents in the educational programme improved significantly in support ( η p 2  = .19) and intrusiveness ( η p 2  = .09) compared to controls.,['SAMPLE\n\n\nParents and their children in a low-risk sample of four- to eight-year-olds'],['educational programme condition (N\xa0=\xa034) or the control condition (N\xa0=\xa036'],['AC and EF'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0341529,Parents in the educational programme improved significantly in support ( η p 2  = .19) and intrusiveness ( η p 2  = .09) compared to controls.,"[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Spruijt', 'Affiliation': 'Department of Clinical Child and Adolescent Studies, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Marielle C', 'Initials': 'MC', 'LastName': 'Dekker', 'Affiliation': 'Department of Clinical Child and Adolescent Studies, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Tim B', 'Initials': 'TB', 'LastName': 'Ziermans', 'Affiliation': 'Department of Clinical Child and Adolescent Studies, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Swaab', 'Affiliation': 'Department of Clinical Child and Adolescent Studies, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, The Netherlands.'}]",The British journal of educational psychology,['10.1111/bjep.12312'] 3160,32107337,"Response-adapted therapy with infusional EPOCH chemotherapy plus rituximab in HIV- associated, B-cell non-Hodgkin's lymphoma.","Four cycles of rituximab plus CHOP chemotherapy is as effective as 6 cycles in low-risk diffuse large B-cell lymphoma (DLBCL). Here we report a post-hoc analysis of a prospective clinical trial in patients with HIV-associated DLBCL and high-grade lymphoma treated with 4-6 cycles of EPOCH plus rituximab based a response-adapted treatment strategy. 106 evaluable patients with HIV-associated DLBCL or high-grade CD20-positive non-Hodgkin's lymphoma were randomized to receive rituximab (375 mg/m2) given either concurrently prior to each infusional EPOCH cycle, or sequentially (weekly for 6 weeks) following completion of EPOCH. EPOCH consisted of a 96-hour IV infusion of etoposide, doxorubicin, and vincristine plus oral prednisone followed by IV bolus cyclophosphamide every 21 days for 4 to 6 cycles. Patients received 2 additional cycles of therapy after documentation of a complete response (CR) by computerized tomography after cycles 2 and 4. 64 of 106 evaluable patients (60%, 95% CI 50%, 70%) had a CR in both treatment arms. The 2-year event-free survival (EFS) rates were similar in the 24 patients with CR who received 4 or fewer EPOCH cycles (78%, 95% confidence intervals [55%, 90%]) due to achieving a CR after 2 cycles, compared with those who received 5-6 cycles of EPOCH (85%, 95% CI 70%, 93%) because a CR was first documented after cycle 4. A response-adapted strategy may permit a shorter treatment duration without compromising therapeutic efficacy in patients with HIV-associated lymphoma treated with EPOCH plus rituximab, which merits further evaluation in additional prospective trials. Clinical Trials.gov identifier NCT00049036.",2020,"The 2-year event-free survival (EFS) rates were similar in the 24 patients with CR who received 4 or fewer EPOCH cycles (78%,","[""HIV- associated, B-cell non-Hodgkin's lymphoma"", 'patients with HIV-associated lymphoma treated with', ""106 evaluable patients with HIV-associated DLBCL or high-grade CD20-positive non-Hodgkin's lymphoma"", 'patients with HIV-associated DLBCL and high-grade lymphoma treated with 4-6 cycles of EPOCH plus rituximab based a response-adapted treatment strategy']","['rituximab', 'cyclophosphamide', 'EPOCH plus rituximab', 'infusional EPOCH chemotherapy plus rituximab', 'rituximab plus CHOP chemotherapy', 'etoposide, doxorubicin, and vincristine plus oral prednisone']",['2-year event-free survival (EFS) rates'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",106.0,0.145786,"The 2-year event-free survival (EFS) rates were similar in the 24 patients with CR who received 4 or fewer EPOCH cycles (78%,","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore-Einstein Cancer Center, Montefiore Medical Center, Bronx, NY, USA; jsparano@montefiore.org.'}, {'ForeName': 'Jeannette Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'University of Miami, Sylvester Comprehensive Cancer Center, Miami, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wachsman', 'Affiliation': 'Moores University of California, San Diego Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aboulafia', 'Affiliation': 'Virginia Mason Cancer Institute, Seattle, WA, USA.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Noy', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Henry', 'Affiliation': 'University of Pennsylvania, Pennsylvania Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ratner', 'Affiliation': 'Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Cesarman', 'Affiliation': 'Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'University of California, Los Angeles Medical Center, Los Angeles, CA, USA.'}]",Haematologica,['10.3324/haematol.2019.243386'] 3161,31302517,The effects of alpha asymmetry and high-beta down-training neurofeedback for patients with the major depressive disorder and anxiety symptoms.,"BACKGROUND Alpha-asymmetry neurofeedback (ALAY) was applied to patients with major depressive disorder (MDD) based on the theory of frontal alpha asymmetry. Neurophysiological studies have found a higher high-beta activity of electroencephalography (EEG) at the posterior cortex among patients with comorbid MDD and anxiety symptoms. The present study examined the effects of ALAY and high-beta down-training (Beta) neurofeedback in symptoms of depression and anxiety and EEG parameters. METHOD Eighty-seven patients with comorbid MDD and anxiety symptoms were allocated to the ALAY, Beta, or control groups. Both neurofeedback groups received ten-session neurofeedback. All participants completed the Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), and five minutes resting EEG recording at pre-test and post-test. EEG raw signals were transformed into an A1 score [log (F4 alpha) - log (F3 alpha)], P3 and P4 high-beta power. RESULTS BDI-II and BAI scores decreased at post-test in both ALAY and Beta groups, but no significant difference between the two groups. No significant interaction effect in A1 score at pre-test and post-test between the ALAY, Beta, and control groups. The P3 high-beta was significantly decreased in the Beta group, an increase in the control group, and no change in the ALAY group at post-test compared to the pre-test. CONCLUSIONS Both neurofeedback groups decreased symptoms of depression and anxiety. The Beta group was more effective in decreasing high-beta power at the parietal cortex compared to other groups. This non-invasive psychological intervention can be used in the future for patients with comorbid MDD and anxiety symptoms.",2019,"The P3 high-beta was significantly decreased in the Beta group, an increase in the control group, and no change in the ALAY group at post-test compared to the pre-test. ","['patients with comorbid MDD and anxiety symptoms', 'patients with major depressive disorder (MDD', 'Eighty-seven patients with comorbid MDD and anxiety symptoms', 'patients with the major depressive disorder and anxiety symptoms']","['Alpha-asymmetry neurofeedback (ALAY', 'alpha asymmetry and high-beta down-training neurofeedback', 'ALAY and high-beta down-training (Beta) neurofeedback']","['high-beta power', 'BDI-II and BAI scores', 'symptoms of depression and anxiety', 'P3 high-beta', 'A1 score [log (F4 alpha) - log (F3 alpha)], P3 and P4 high-beta power', 'Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), and five minutes resting EEG recording']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]",87.0,0.0139053,"The P3 high-beta was significantly decreased in the Beta group, an increase in the control group, and no change in the ALAY group at post-test compared to the pre-test. ","[{'ForeName': 'San-Yu', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, College of Humanities and Social Sciences, Kaohsiung Medical University, Taiwan.'}, {'ForeName': 'I-Mei', 'Initials': 'IM', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, College of Humanities and Social Sciences, Kaohsiung Medical University, Taiwan; Pervasive Artificial Intelligence Research (PAIR) Labs, Taiwan; Department of Medical Research, Kaohsiung Medical University Hospital, Taiwan. Electronic address: psyiml@kmu.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Fan', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Taiwan.'}, {'ForeName': 'Yu-Che', 'Initials': 'YC', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychology, College of Humanities and Social Sciences, Kaohsiung Medical University, Taiwan.'}, {'ForeName': 'Cheng-Fang', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Psychiatry, Kaohsiung Medical University Hospital, Taiwan; Graduate Institute of Medicine, and Department of Psychiatry, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, Kaohsiung Medical University Hospital, Taiwan; Graduate Institute of Medicine, and Department of Psychiatry, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Mei-Feng', 'Initials': 'MF', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Kaohsiung Medical University Hospital, Taiwan; Graduate Institute of Medicine, and Department of Psychiatry, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Nien-Mu', 'Initials': 'NM', 'LastName': 'Chiu', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Chi-Fa', 'Initials': 'CF', 'LastName': 'Hung', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Peng-Wei', 'Initials': 'PW', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Kaohsiung Medical University Hospital, Taiwan; Graduate Institute of Medicine, and Department of Psychiatry, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tai-Ling', 'Initials': 'TL', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Kaohsiung Medical University Hospital, Taiwan; Graduate Institute of Medicine, and Department of Psychiatry, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Huang-Chi', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Kaohsiung Medical University Hospital, Taiwan; Graduate Institute of Medicine, and Department of Psychiatry, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.026'] 3162,32099583,A Nomogram Based on Apelin-12 for the Prediction of Major Adverse Cardiovascular Events after Percutaneous Coronary Intervention among Patients with ST-Segment Elevation Myocardial Infarction.,"Objective This study aimed to establish a clinical prognostic nomogram for predicting major adverse cardiovascular events (MACEs) after primary percutaneous coronary intervention (PCI) among patients with ST-segment elevation myocardial infarction (STEMI). Methods Information on 464 patients with STEMI who performed PCI procedures was included. After removing patients with incomplete clinical information, a total of 460 patients followed for 2.5 years were randomly divided into evaluation ( n  = 324) and validation ( n  = 324) and validation (. Results Apelin-12 change rate, apelin-12 level, age, pathological Q wave, myocardial infarction history, anterior wall myocardial infarction, Killip's classification > I, uric acid, total cholesterol, cTnI, and the left atrial diameter were independently associated with MACEs (all P < 0.05). After incorporating these 11 factors, the nomogram achieved good concordance indexes of 0.758 (95%CI = 0.707-0.809) and 0.763 (95%CI = 0.689-0.837) in predicting MACEs in the evaluation and validation cohorts, respectively, and had well-fitted calibration curves. The decision curve analysis (DCA) revealed that the nomogram was clinically useful. Conclusions We established and validated a novel nomogram that can provide individual prediction of MACEs for patients with STEMI after PCI procedures in a Chinese population. This practical prognostic nomogram may help clinicians in decision making and enable a more accurate risk assessment.",2020,"Results Apelin-12 change rate, apelin-12 level, age, pathological Q wave, myocardial infarction history, anterior wall myocardial infarction, Killip's classification > ","['patients with STEMI after PCI procedures in a Chinese population', 'patients with incomplete clinical information, a total of 460 patients followed for 2.5 years', 'patients with ST-segment elevation myocardial infarction (STEMI', 'Patients with ST-Segment Elevation Myocardial Infarction', '464 patients with STEMI who performed PCI procedures was included']",['primary percutaneous coronary intervention (PCI'],"['uric acid, total cholesterol, cTnI, and the left atrial diameter', ""Results\n\n\nApelin-12 change rate, apelin-12 level, age, pathological Q wave, myocardial infarction history, anterior wall myocardial infarction, Killip's classification\u2009""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1531140', 'cui_str': 'apelin-12 peptide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0429090', 'cui_str': 'Pathological Q wave (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0340293', 'cui_str': 'Anterior Wall Myocardial Infarction'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}]",464.0,0.021616,"Results Apelin-12 change rate, apelin-12 level, age, pathological Q wave, myocardial infarction history, anterior wall myocardial infarction, Killip's classification > ","[{'ForeName': 'Enfa', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': ""Department of Structural Heart Disease, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ""Department of Structural Heart Disease, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Yushun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Structural Heart Disease, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}]",Cardiovascular therapeutics,['10.1155/2020/9416803'] 3163,32107188,"Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Retinal Vein Occlusion: The Bevacizumab to Ranibizumab in Retinal Vein Occlusions (BRVO) study, a Randomized Trial.","PURPOSE Comparing the efficacy of intravitreal injections of bevacizumab to ranibizumab in the treatment of macular edema (ME) resulting from retinal vein occlusion (RVO). DESIGN Comparative, randomized, double-masked, multicenter, noninferiority clinical trial. The noninferiority margin was 4 letters. PARTICIPANTS Patients with vision loss resulting from ME secondary to a branch or (hemi) central RVO who might benefit from anti-vascular endothelial growth factor treatment were eligible for participation. METHODS From June 2012 through February 2018, 277 participants were randomized to receive injections of 1.25 mg bevacizumab (n = 139) or 0.5 mg ranibizumab (n = 138). The follow-up was 6 months with a monthly dosing interval. MAIN OUTCOME MEASURES The primary outcome was a change in visual acuity from baseline at 6 months. Changes in the central area thickness and safety were studied as secondary outcomes. RESULTS The mean visual acuity (±standard deviation) improved, with 15.3±13.0 letters for bevacizumab and 15.5±13.3 letters for ranibizumab after 6 months of monthly treatment. The lower limit of the 2-sided 90% confidence interval was -1.724 letters, which is within the noninferiority margin of 4 letters. Even in the branch and (hemi-)central RVO subgroups, minimal differences were found in visual acuity outcomes between treatment arms. Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group. Severe adverse events (SAEs) were also distributed equally over both treatment groups: 10 participants (7.1%) in the bevacizumab group and 13 participants (9.2%) in the ranibizumab group experienced SAEs. CONCLUSIONS This study showed, based on the change in visual acuity, that bevacizumab is noninferior to ranibizumab for patients with ME resulting from RVO of either subtype when receiving monthly injections for a period of 6 months. In addition, anatomic and safety outcomes did not differ between treatment groups. Based on our findings, bevacizumab may be an effective alternative to ranibizumab.",2020,"Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group.","['From June 2012 through February 2018, 277 participants', 'Retinal Vein Occlusions (BRVO', 'patients with ME', 'Patients with Retinal Vein Occlusion', 'Patients with vision loss resulting from ME secondary to a branch or (hemi) central RVO who might benefit from anti-vascular endothelial growth factor treatment were eligible for participation', 'macular edema (ME) resulting from retinal vein occlusion (RVO']","['bevacizumab to ranibizumab', 'ranibizumab', 'bevacizumab', 'Bevacizumab and Ranibizumab', 'Bevacizumab to Ranibizumab']","['Severe adverse events (SAEs', 'anatomic and safety outcomes', 'change in visual acuity', 'central area thickness on OCT', 'visual acuity outcomes', 'visual acuity', 'mean visual acuity (±standard deviation']","[{'cui': 'C0035328', 'cui_str': 'Retinal Vein Occlusion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",277.0,0.329751,"Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group.","[{'ForeName': 'Maartje J C', 'Initials': 'MJC', 'LastName': 'Vader', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ann-Sofie M E', 'Initials': 'AME', 'LastName': 'Schauwvlieghe', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Verbraak', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Greetje', 'Initials': 'G', 'LastName': 'Dijkman', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Johanna M M', 'Initials': 'JMM', 'LastName': 'Hooymans', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen, and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Leonoor I', 'Initials': 'LI', 'LastName': 'Los', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen, and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Department of Ophthalmology, Queens University Belfast, Belfast, United Kingdom.'}, {'ForeName': 'Carel B', 'Initials': 'CB', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Redmer', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Vingerling', 'Affiliation': 'Department of Ophthalmology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'de Jong-Hesse', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke J C', 'Initials': 'JJC', 'LastName': 'van Lith-Verhoeven', 'Affiliation': 'Department of Ophthalmology, Elisabeth-Twee Steden (ETZ) Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Reinier O', 'Initials': 'RO', 'LastName': 'Schlingemann', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands; Department of Ophthalmology, University of Lausanne, Jules-Gonin Eye Hospital, Lausanne, Switzerland. Electronic address: r.o.schlingemann@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2019.12.019'] 3164,31486915,Biceps tenotomy has earlier pain relief compared to biceps tenodesis: a randomized prospective study.,"PURPOSE Surgical management for long head of the biceps (LHB) tendinopathy with either biceps tenotomy or tenodesis is a reliable, but debated treatment option. The aim of this prospective, randomized, single-blinded study is to evaluate differences in pain relief and subjective outcomes between biceps tenotomy versus tenodesis for LHB tendinopathy. METHODS Subjects were randomized and blinded to biceps tenotomy versus arthroscopic tenodesis intra-operatively. Outcomes evaluated included subjective patient outcome scores, pain, and cosmetic deformity. Subjective outcomes scores and pain were analyzed using a two-way ANOVA, controlling for concomitant rotator cuff repair. Binary outcomes were compared using Chi-square tests. RESULTS Thirty-four subjects (31 male, 3 female) with a median age of 56 (range 30-77) were enrolled. Twenty subjects were randomized to tenotomy and 14 to tenodesis. Fifty-six percent had concomitant rotator cuff repairs. The mean VAS pain score at 3 months was lower with tenotomy versus tenodesis. 2-year follow-up demonstrated no statistically significant differences for VAS, ASES, or SANE. 15/20 (75%) subjects with biceps tenotomy reported no pain medication use at the 2-week postoperative visit versus 5/14 (33%) for biceps tenodesis. Popeye deformity was found in 5/20 (25%) of tenotomy subjects versus 1/14 (7%) in tenodesis subjects. CONCLUSION Outcomes appear similar between biceps tenotomy versus tenodesis; however, the tenotomy group demonstrated greater incidence of cosmetic deformity but an earlier improvement in postoperative pain. LEVEL OF EVIDENCE Treatment Studies, Level II.",2019,"2-year follow-up demonstrated no statistically significant differences for VAS, ASES, or SANE.","['Twenty subjects were randomized to tenotomy and 14 to tenodesis', 'Thirty-four subjects (31 male, 3 female) with a median age of 56 (range 30-77) were enrolled', 'Subjects']","['Biceps tenotomy', 'biceps tenotomy versus arthroscopic tenodesis intra-operatively']","['postoperative pain', 'subjective patient outcome scores, pain, and cosmetic deformity', 'Subjective outcomes scores and pain', 'pain medication', 'pain relief', 'mean VAS pain score', 'concomitant rotator cuff repairs', 'pain relief and subjective outcomes', 'Popeye deformity', 'VAS, ASES, or SANE', 'cosmetic deformity']","[{'cui': 'C0856438', 'cui_str': 'Tenotomy (psoas)'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0856438', 'cui_str': 'Tenotomy (psoas)'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]",34.0,0.0420581,"2-year follow-up demonstrated no statistically significant differences for VAS, ASES, or SANE.","[{'ForeName': 'Elshaday S', 'Initials': 'ES', 'LastName': 'Belay', 'Affiliation': 'Department of Orthopaedic Surgery, Durham Veterans Affairs Medical Center, Duke University Medical Center, Box 3000, Durham, NC, 27710, UK. Elshaday.Belay@duke.edu.'}, {'ForeName': 'Jocelyn R', 'Initials': 'JR', 'LastName': 'Wittstein', 'Affiliation': 'Department of Orthopaedic Surgery, Durham Veterans Affairs Medical Center, Duke University Medical Center, Box 3000, Durham, NC, 27710, UK.'}, {'ForeName': 'Grant E', 'Initials': 'GE', 'LastName': 'Garrigues', 'Affiliation': 'Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, USA.'}, {'ForeName': 'Tally E', 'Initials': 'TE', 'LastName': 'Lassiter', 'Affiliation': 'Department of Orthopaedic Surgery, Durham Veterans Affairs Medical Center, Duke University Medical Center, Box 3000, Durham, NC, 27710, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Scribani', 'Affiliation': 'Center for Biostatistics, Bassett Research Institute, Cooperstown, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Goldner', 'Affiliation': 'Department of Orthopaedic Surgery, Durham Veterans Affairs Medical Center, Duke University Medical Center, Box 3000, Durham, NC, 27710, UK.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Bean', 'Affiliation': 'Department of Orthopaedic Surgery, Durham Veterans Affairs Medical Center, Duke University Medical Center, Box 3000, Durham, NC, 27710, UK.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05682-1'] 3165,32092190,"Randomized, Controlled Trial of Exercise on Objective and Subjective Sleep in Parkinson's Disease.","BACKGROUND Sleep dysfunction is common and disabling in persons with Parkinson's Disease (PD). Exercise improves motor symptoms and subjective sleep quality in PD, but there are no published studies evaluating the impact of exercise on objective sleep outcomes. The goal of this study was to to determine if high-intensity exercise rehabilitation combining resistance training and body-weight interval training, compared with a sleep hygiene control improved objective sleep outcomes in PD. METHODS Persons with PD (Hoehn & Yahr stages 2-3; aged ≥45 years, not in a regular exercise program) were randomized to exercise (supervised 3 times a week for 16 weeks; n = 27) or a sleep hygiene, no-exercise control (in-person discussion and monthly phone calls; n = 28). Participants underwent polysomnography at baseline and post-intervention. Change in sleep efficiency was the primary outcome, measured from baseline to post-intervention. Intervention effects were evaluated with general linear models with measurement of group × time interaction. As secondary outcomes, we evaluated changes in other aspects of sleep architecture and compared the effects of acute and chronic training on objective sleep outcomes. RESULTS The exercise group showed significant improvement in sleep efficiency compared with the sleep hygiene group (group × time interaction: F = 16.0, P < 0.001, d = 1.08). Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep. Chronic but not acute exercise improved sleep efficiency compared with baseline. CONCLUSIONS High-intensity exercise rehabilitation improves objective sleep outcomes in PD. Exercise is an effective nonpharmacological intervention to improve this disabling nonmotor symptom in PD. © 2020 International Parkinson and Movement Disorder Society.",2020,"Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep.","['Persons with PD (Hoehn & Yahr stages 2-3; aged ≥45\u2009years, not in a regular exercise program', ""Parkinson's Disease"", 'PD', ""persons with Parkinson's Disease (PD""]","['Exercise', 'High-intensity exercise rehabilitation', 'sleep hygiene, no-exercise control', 'high-intensity exercise rehabilitation combining resistance training and body-weight interval training']","['total sleep time, wake after sleep onset, and slow-wave sleep', 'Objective and Subjective Sleep', 'sleep efficiency', 'motor symptoms and subjective sleep quality', 'objective sleep outcomes']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.070578,"Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep.","[{'ForeName': 'Amy W', 'Initials': 'AW', 'LastName': 'Amara', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Kimberly H', 'Initials': 'KH', 'LastName': 'Wood', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Joop', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Raima A', 'Initials': 'RA', 'LastName': 'Memon', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pilkington', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reams', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Arthur L', 'Initials': 'AL', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Hurt', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28009'] 3166,32090464,Association between perioperative intraperitoneal local anaesthetic infusion and long-term survival and cancer recurrence after colectomy: follow-up analysis of a previous randomized controlled trial.,"BACKGROUND High concentrations of local anaesthetic have an anti-proliferative effect on colonic cancer in vitro. Intraperitoneal local anaesthetic (IPLA) has shown analgesic benefit and improved recovery in the perioperative setting. The long-term effects of IPLA in colon cancer resection have not been examined. This study aims to review the survival and oncological outcomes of a previously conducted trial that compared perioperative IPLA with placebo. METHODS Sixty patients underwent colonic resection for benign and malignant disease as part of a double-blinded, randomized, placebo-controlled study between September 2008 and November 2009. The IPLA group received instillation of intraperitoneal ropivacaine before dissection followed by a 3-day infusion. The placebo group was treated identically but with 0.9% saline solution. A follow-up analysis was conducted to evaluate overall survival, disease-free survival and recurrence specifically for patients undergoing resection for stages I-III colon cancer. Kaplan-Meier analysis was performed, and the log-rank test was used to evaluate difference in survival between groups. RESULTS Thirty-seven of the 60 patients had stages I-III colon cancer and were included in this analysis. Nineteen patients were in the placebo group. There was no significant difference in overall survival or all-cause mortality. There was a higher incidence of cancer-specific mortality in the local anaesthetic group (P < 0.046). CONCLUSION It does not appear that IPLA is associated with a significant survival benefit in patients with colonic malignancy undergoing colectomy. Other studies are needed to analyse the long-term outcomes.",2020,"There was a higher incidence of cancer-specific mortality in the local anaesthetic group (P < 0.046). ","['Thirty-seven of the 60 patients had stages I-III colon cancer', 'Nineteen patients were in the placebo group', 'Sixty patients underwent', 'controlled study between September 2008 and November 2009', 'patients with colonic malignancy undergoing colectomy', 'patients undergoing resection for stages I-III colon cancer']","['IPLA', 'placebo', 'intraperitoneal ropivacaine', 'colonic resection', 'Intraperitoneal local anaesthetic (IPLA', 'saline solution']","['survival benefit', 'overall survival, disease-free survival and recurrence', 'cancer recurrence', 'cancer-specific mortality', 'survival', 'overall survival']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C2830173', 'cui_str': 'iPLA(2)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",19.0,0.762434,"There was a higher incidence of cancer-specific mortality in the local anaesthetic group (P < 0.046). ","[{'ForeName': 'Wiremu S', 'Initials': 'WS', 'LastName': 'MacFater', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Weisi', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ahmed W H', 'Initials': 'AWH', 'LastName': 'Barazanchi', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Hoani S', 'Initials': 'HS', 'LastName': 'MacFater', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lightfoot', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Svirskis', 'Affiliation': 'Department of Pharmacy, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Arman A', 'Initials': 'AA', 'LastName': 'Kahokehr', 'Affiliation': 'Division of Surgery and Anaesthetics, Northern Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Hill', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}]",ANZ journal of surgery,['10.1111/ans.15753'] 3167,31682572,Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial.,"BACKGROUND Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (P=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (P=.001). CONCLUSIONS The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants' age and baseline depression severity are of interest in relation to used study methods. TRIAL REGISTRATION ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205.",2019,"Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51).","['162 adolescents registered and completed the baseline screening', 'adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70', 'Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70', 'Adolescent Depression', 'adolescent depression, including major depressive episode (MDE']","['ICBT', 'minimal attention control', 'Internet-delivered cognitive behavioral therapies (ICBTs', 'Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions']","['secondary depression outcome', 'average intervention completion', 'Depression', 'depression symptoms', 'self-reported depression level as measured with the Beck Depression Inventory']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4517493', 'cui_str': '1.15'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0946707', 'cui_str': 'Chat'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",162.0,0.261322,"Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51).","[{'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Byléhn', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Dahlström Nysäter', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Holmlund', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lindegaard', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Åberg', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Bergman Nordgren', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zetterqvist', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Journal of medical Internet research,['10.2196/13393'] 3168,32037380,Lifestyle Modification or Medication to Improve Condition of Patients With Asymptomatic Heart Failure　- Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization II (MOMOTARO II) Study.,"BACKGROUND In heart failure (HF) patients implanted with high-energy devices, worsening of HF can be diagnosed from intrathoracic impedance (ITI) before symptoms appear. Early therapeutic intervention can prevent HF worsening, but the optimal intervention remains unknown. This study aimed to examine which lifestyle modifications or medications can improve HF indicators in asymptomatic HF patients diagnosed from ITI.Methods and Results:This multicenter, prospective, randomized study included patients with high-energy devices, left ventricular ejection fraction <40%, or with a history of HF hospitalization. After the OptiVol alert was evoked by decreased ITI, patients underwent examinations. If they were diagnosed with HF, they were randomly assigned to 3 groups: lifestyle modification, diuretic, or nitrate. After 1 week, they underwent the same examinations. The primary endpoint was change in ITI and serum B-type natriuretic peptide (BNP). Totally, 57 patients were randomized. In all 3 groups, ITI was significantly increased post-intervention compared with pre-intervention. In the diuretic and nitrate groups, logBNP post-intervention was significantly lower than pre-intervention, but not in the lifestyle modification group. CONCLUSIONS Compared with lifestyle modifications, diuretic and nitrate therapy for 1 week may be more effective management of HF detected by decreased ITI. However, lifestyle modification may have the additional benefits of reducing the workload or cost.",2020,"In the diuretic and nitrate groups, logBNP post-intervention was significantly lower than pre-intervention, but not in the lifestyle modification group. ","['patients with high-energy devices, left ventricular ejection fraction <40%, or with a history of HF hospitalization', 'Patients With Asymptomatic Heart Failure\u3000- Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization II (MOMOTARO II) Study', 'asymptomatic HF patients diagnosed from ITI.Methods\u2004and\u2004Results', '57 patients were randomized']","['diuretic and nitrate therapy', 'lifestyle modification, diuretic, or nitrate', 'Lifestyle Modification or Medication']","['HF indicators', 'change in ITI and serum B-type natriuretic peptide (BNP', 'ITI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0063763', 'cui_str': 'iodo-tyraminyl inulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}]",57.0,0.0259082,"In the diuretic and nitrate groups, logBNP post-intervention was significantly lower than pre-intervention, but not in the lifestyle modification group. ","[{'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Nishii', 'Affiliation': 'Department of Cardiovascular Therapeutics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Kurashiki Central Hospital.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiovascular Medicine, Fukuyama City Hospital.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kawamoto', 'Affiliation': 'Department of Cardiovascular Medicine, National Hospital Organization Iwakuni Clinical Center.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Okawa', 'Affiliation': 'Department of Cardiovascular Medicine, Kagawa Prefectural Central Hospital.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Cardiovascular Medicine, Fukuyama Cardiovascular Hospital.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morita', 'Affiliation': 'Department of Cardiovascular Therapeutics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0986'] 3169,32023574,High Predictive Value of Adenosine Provocation in Predicting Atrial Fibrillation Recurrence After Pulmonary Vein Isolation With Visually Guided Laser Balloon Compared With Radiofrequency Ablation.,"BACKGROUND We recently demonstrated that the acute reconnection rate detected with adenosine provocation test (APT) was significantly lower after pulmonary vein isolation (PVI) with visually guided laser balloon ablation (VGLB) than with RF ablation (RF). We evaluated the recurrence rate of atrial arrhythmias at 12 months after VGLB vs. RF and the significance of APT results for the outcome.Methods and Results:Fifty patients with paroxysmal AF were randomized to either RF or VGLB ablation in a 1 : 1 fashion. After PVI each PV underwent an APT. All patients underwent a 3-day Holter and clinical follow-up every 3 months. Significantly less PVs reconnected during APT in the VGLB-arm (10 PV (10.8%) vs. 29 PV (30.9%); P=0.001). Significantly less patients had a recurrence of atrial arrhythmia in the VGLB-arm (3 vs. 9; P=0.047). In the VGLB-arm no recurrence was seen in those patients with a negative APT (negative predictive value (NPV)=100%). Only 3 of the 8 patients with a positive APT in the VGLB-arm had a recurrence (positive PV (PPV)=37%). Recurrences in the RF-arm were seen in 3 patients with positive APT as well as in 6 patients with negative APT (PPV=18% and NPV=33%). CONCLUSIONS There was significantly less recurrence of atrial arrhythmias at 12 months after PVI with VGLB. A negative APT after PVI with VGBL predicted freedom from AF with a very high NPV meaning that the high acute efficiency of the VGLB persisted long term.",2020,"Recurrences in the RF-arm were seen in 3 patients with positive APT as well as in 6 patients with negative APT (PPV=18% and NPV=33%). ",['Fifty patients with paroxysmal AF'],"['Adenosine Provocation', 'adenosine provocation test (APT', 'RF or VGLB ablation', 'pulmonary vein isolation (PVI) with visually guided laser balloon ablation (VGLB) than with RF ablation (RF', 'Radiofrequency Ablation', 'Visually Guided Laser Balloon']","['Recurrences', 'recurrence rate of atrial arrhythmias', 'recurrence of atrial arrhythmias', 'Atrial Fibrillation Recurrence', 'recurrence of atrial arrhythmia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]","[{'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}]",8.0,0.0420804,"Recurrences in the RF-arm were seen in 3 patients with positive APT as well as in 6 patients with negative APT (PPV=18% and NPV=33%). ","[{'ForeName': 'Ekrem', 'Initials': 'E', 'LastName': 'Üçer', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Fredersdorf', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Seegers', 'Affiliation': 'Klinikum Landshut, Internal Medicine I, Cardiology.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Poschenrieder', 'Affiliation': 'Radiology, University Hospital Regensburg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hauck', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Maier', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Jungbauer', 'Affiliation': 'Internal Medicine II, Cardiology, University Hospital Regensburg.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0993'] 3170,31387119,Examining the Effect of Fish Oil Supplementation in Chinese Pregnant Women on Gestation Duration and Risk of Preterm Delivery.,"BACKGROUND Intervention studies have shown that long-chain (LC) n-3 PUFA intake can prolong gestation but the dose-time-effect relations remain unresolved. OBJECTIVES We examined the effect on gestation duration of 2 doses of supplemental LC n-3 PUFAs. METHODS We undertook a 3-group parallel randomized controlled trial in areas of China with low (median: 2.1 g/d) and higher (14.3 g/d) fish intake. Unselected women (median: age, 26.2 y; BMI, 20. kg/m2) were randomly assigned at midgestation to take four 0.72-g identical gelatin capsules per day until the last day of the preterm period (<259 days of gestation), when they were asked to stop. Capsules contained fish oil [high fish oil (HFO) group (60% w/w LC n-3 PUFAs)], a 1:3 mixture of fish oil to olive oil [low fish oil (LFO) group (20%)], or olive oil [control (CON) group (0%)], providing 2.0, 0.5, and 0 g/d of LC n-3 PUFAs, respectively. Habitual fish intake was recorded at baseline. Hazard rate ratios (HRRs) for spontaneous delivery <259 days of gestation and <273 days of gestation across groups were estimated by Cox regression. RESULTS Among 5531 women randomly assigned, 92.5% were included in analyses (1706/1825, 1695/1851, and 1717/1855, respectively). The groups were similar with respect to hazard rates <259 days of gestation [HRR: 1.04 (95% CI: 0.70, 1.53) for LFO compared with CON and 0.90 (95% CI: 0.60, 1.35) for HFO compared with CON], hazard rates <273 days of gestation [HRR: 1.00 (95% CI: 0.86, 1.18) and 0.91 (95% CI: 0.77, 1.07), respectively], and mean gestation durations [differences: 0.2 d (95% CI: -0.5, 0.8) and 0.6 d (95% CI: -0.06, 1.2), respectively]. Inspection of pregnancy survival curves suggested that LC n-3 PUFAs delayed delivery in low fish consumers by 5-10 d and that this effect ceased rapidly after stopping taking the capsules. CONCLUSION This trial could not substantiate that fish oil prevents preterm birth in Chinese women, possibly because statistical power was too low. This trial was registered at clinicaltrials.gov as NCT02770456.",2019,"The groups were similar with respect to hazard rates <259 days of gestation [HRR: 1.04 (95% CI: 0.70, 1.53) for LFO compared with CON and 0.90 (95% CI: 0.60, 1.35) for HFO compared with CON], hazard rates <273 days of gestation [HRR: 1.00 (95% CI: 0.86, 1.18) and 0.91 (95% CI: 0.77, 1.07), respectively], and mean gestation durations [differences: 0.2 d (95% CI: -0.5, 0.8) and 0.6 d (95% CI: -0.06, 1.2), respectively].","['Chinese women', 'Unselected women (median: age, 26.2 y; BMI, 20. kg/m2', 'areas of China with low (median: 2.1 g/d) and higher (14.3 g/d) fish intake', 'Chinese Pregnant Women on Gestation Duration and Risk of Preterm Delivery', '5531 women randomly assigned, 92.5% were included in analyses (1706/1825, 1695/1851, and 1717/1855, respectively']","['long-chain (LC) n-3 PUFA intake', 'CON', 'olive oil [control (CON', 'supplemental LC n-3 PUFAs', 'Capsules contained fish oil [high fish oil (HFO', 'fish oil to olive oil [low fish oil (LFO', 'Fish Oil Supplementation']","['Habitual fish intake', 'preterm birth', 'Hazard rate ratios (HRRs', 'mean gestation durations']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0098700', 'cui_str': '5531'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.715921,"The groups were similar with respect to hazard rates <259 days of gestation [HRR: 1.04 (95% CI: 0.70, 1.53) for LFO compared with CON and 0.90 (95% CI: 0.60, 1.35) for HFO compared with CON], hazard rates <273 days of gestation [HRR: 1.00 (95% CI: 0.86, 1.18) and 0.91 (95% CI: 0.77, 1.07), respectively], and mean gestation durations [differences: 0.2 d (95% CI: -0.5, 0.8) and 0.6 d (95% CI: -0.06, 1.2), respectively].","[{'ForeName': 'Sjurdur F', 'Initials': 'SF', 'LastName': 'Olsen', 'Affiliation': 'Centre for Fetal Programming, Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Thorhallur I', 'Initials': 'TI', 'LastName': 'Halldorsson', 'Affiliation': 'Centre for Fetal Programming, Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Strøm', 'Affiliation': 'Centre for Fetal Programming, Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Che', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Nutrition and Food Hygiene Institute, School of Public Health, Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Fengxian', 'Initials': 'F', 'LastName': 'Duan', 'Affiliation': ""Shaanxi Health and Family Planning Commission, Xi'an, China.""}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Olsen', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Weijin', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}]",The Journal of nutrition,['10.1093/jn/nxz153'] 3171,32035035,Effectiveness and cost-effectiveness of group support psychotherapy delivered by trained lay health workers for depression treatment among people with HIV in Uganda: a cluster-randomised trial.,"BACKGROUND WHO recommends the use of psychological interventions as first-line treatment for depression in low-income and middle-income countries. However, evaluations of the effectiveness and cost-effectiveness of such interventions among people with HIV are scarce. Our aim was to establish the effectiveness of group support psychotherapy (GSP) delivered by lay health workers for depression treatment among people living with HIV in a rural area of Uganda on a large scale. METHODS In this cluster-randomised trial, we included 30 health centres offering HIV care. These were randomly assigned to deliver either GSP or group HIV education (GHE). Randomisation, in a ratio of 1:1, was achieved by health centre managers separately picking a paper containing the intervention allocation from a basket. Participants were people living with HIV, aged 19 years and older, with mild to moderate major depression assessed with the Mini International Neuropsychiatric Interview depression module, taking antiretroviral therapy, and antidepressant-naive. Group sessions were led by trained lay health workers once a week for 8 weeks. The primary outcomes were the proportion of participants with major depression and function scores at 6 months post-treatment, analysed by intention to treat by means of multilevel random effect regression analyses adjusting for clustering in health centres. This trial is registered with the Pan African Clinical Trials Registry, PACTR201608001738234. FINDINGS Between Sept 13 and Dec 15, 2016, we assessed 1473 individuals, of whom 1140 were recruited from health centres offering GSP (n=578 [51%]) or GHE (n=562 [49%]). Two (<1%) participants in the GSP group were diagnosed with major depression 6 months post-treatment compared with 160 (28%) in the GHE group (adjusted odds ratio=0·01, 95% CI 0·003-0·012, p<0·0001). The mean function scores 6 months post-treatment were 9·85 (SD 0·76) in the GSP group and 6·83 (2·85) in the GHE group (β=4·12; 95% CI 3·75-4·49, p<0·0001). 36 individuals had 63 serious adverse events, which included 25 suicide attempts and 22 hospital admissions for medical complications. The outcomes of these serious adverse events included 16 deaths, 4 of which were completed suicides (GSP=2; GHE=2), and 12 of which were HIV-related medical complications (GSP=8; GHE=4). Cost-effectiveness estimates showed an incremental cost-effectiveness ratio of US$13·0 per disability-adjusted life-year averted, which can be considered very cost-effective in Uganda. INTERPRETATION Integration of cost-effective psychological treatments such as group support psychotherapy into existing HIV interventions might improve the mental health of people living with HIV. FUNDING MQ Transforming Mental Health and Grand Challenges Canada.",2020,"The mean function scores 6 months post-treatment were 9·85 (SD 0·76) in the GSP group and 6·83 (2·85) in the GHE group (β=4·12; 95% CI 3·75-4·49, p<0·0001).","['people with HIV are scarce', 'Between Sept 13 and Dec 15, 2016', 'trained lay health workers for depression treatment among people with HIV in Uganda', 'people living with HIV in a rural area of Uganda on a large scale', '1473 individuals, of whom 1140 were recruited from health centres offering GSP (n=578 [51%]) or GHE (n=562 [49', 'people living with HIV', 'Participants were people living with HIV, aged 19 years and older, with mild to moderate major depression assessed with the Mini International Neuropsychiatric Interview depression module, taking antiretroviral therapy, and antidepressant-naive', '36 individuals had 63 serious adverse events, which included 25 suicide attempts and 22 hospital admissions for medical complications', '30 health centres offering HIV care']","['group support psychotherapy', 'GSP or group HIV education (GHE', 'group support psychotherapy (GSP']","['effectiveness and cost-effectiveness', 'Effectiveness and cost-effectiveness', 'proportion of participants with major depression and function scores', 'mean function scores']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517539', 'cui_str': 'One thousand one hundred and forty'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1140.0,0.181347,"The mean function scores 6 months post-treatment were 9·85 (SD 0·76) in the GSP group and 6·83 (2·85) in the GHE group (β=4·12; 95% CI 3·75-4·49, p<0·0001).","[{'ForeName': 'Etheldreda', 'Initials': 'E', 'LastName': 'Nakimuli-Mpungu', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda. Electronic address: ethelnakimuli@chs.mak.ac.ug.'}, {'ForeName': 'Seggane', 'Initials': 'S', 'LastName': 'Musisi', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kizito', 'Initials': 'K', 'LastName': 'Wamala', 'Affiliation': 'Department of Psychology, Center for Victims of Torture, Gulu, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Okello', 'Affiliation': 'Department of Mental Health, Faculty of Medicine, Gulu University, Gulu, Uganda.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ndyanabangi', 'Affiliation': 'Mental Health Program, Ministry of Health of Uganda, Kampala, Uganda.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Birungi', 'Affiliation': 'The AIDS Support Organization, Kampala, Uganda.'}, {'ForeName': 'Mastula', 'Initials': 'M', 'LastName': 'Nanfuka', 'Affiliation': 'The AIDS Support Organization, Kampala, Uganda.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Etukoit', 'Affiliation': 'The AIDS Support Organization, Kampala, Uganda.'}, {'ForeName': 'Chrispus', 'Initials': 'C', 'LastName': 'Mayora', 'Affiliation': 'Department of Health Policy Planning and Management, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Freddie', 'Initials': 'F', 'LastName': 'Ssengooba', 'Affiliation': 'Department of Health Policy Planning and Management, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jean B', 'Initials': 'JB', 'LastName': 'Nachega', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA; Infectious Diseases and Microbiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA; Center for Infectious Disease, Department of Medicine, Stellenbosch University Faculty of Medicine and Health Sciences, Cape Town, South Africa.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Harari', 'Affiliation': 'MTEK Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mills', 'Affiliation': 'MTEK Sciences, Vancouver, BC, Canada; Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30548-0'] 3172,31477783,Do young children consistently meet 24-h sleep and activity guidelines? A longitudinal analysis using actigraphy.,"BACKGROUND Existing studies examining adherence to 24-h movement guidelines in young children are mostly cross sectional and have not assessed additional guidelines relating to activity intensity or regularity in sleep patterns. The aims of this study were to determine adherence to full sleep, activity, and sedentary behaviour guidelines from 1-5 years of age, whether adherence tracked over time, and how adherence was related to body composition cross sectionally and prospectively. SUBJECTS/METHODS Data were obtained from 547 children who were participants in a randomised controlled trial. At 1, 2, and 5 years of age, children wore Actical accelerometers 24-h a day for 5-7 days, height and weight were measured, and parents completed questionnaires on screen time and restraint (1 and 2 years only). A dual-energy x-ray absorptiometry (DXA) scan measured body composition at 5 years of age. RESULTS Although adherence to general sleep and activity guidelines was high, few children had regular sleep patterns. Adherence to all three guidelines ranged from 12.3 to 41.3% at the different ages, although these estimates decreased to 0.6-9.3% when activity intensity (60 min of energetic play) and sleep regularity (consistent sleep and wake times) were included. Children who met all three guidelines at a given age were more likely to meet all three guidelines at a subsequent age (odds ratio, 95% CI: 2.6, 1.04-6.4 at 1 year and 2.5, 1.1-5.9 at 2 years). However, adherence to meeting all three guidelines at earlier ages was not related to BMI z-score or body composition at age 5, either cross sectionally or prospectively. CONCLUSIONS Strategies to promote adherence to movement guidelines among young children are warranted, particularly to reduce screen time, and encouraging regular sleep patterns.",2019,"However, adherence to meeting all three guidelines at earlier ages was not related to BMI z-score or body composition at age 5, either cross sectionally or prospectively. ","['young children', 'Data were obtained from 547 children who were participants in a randomised controlled trial']",['dual-energy x-ray absorptiometry (DXA) scan'],"['Adherence', 'sleep regularity (consistent sleep and wake times', 'adherence to full sleep, activity, and sedentary behaviour guidelines']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1959592', 'cui_str': 'DEXA Scan'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449581', 'cui_str': 'Regularity (attribute)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",547.0,0.0356099,"However, adherence to meeting all three guidelines at earlier ages was not related to BMI z-score or body composition at age 5, either cross sectionally or prospectively. ","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Meredith-Jones', 'Affiliation': 'Department of Medicine, Dunedin, New Zealand. kim.meredith-jones@otago.ac.nz.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, Dunedin, New Zealand.""}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Haszard', 'Affiliation': 'Department of Medicine, Dunedin, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Centre for Biostatistics, Dunedin, New Zealand.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sayers', 'Affiliation': ""Department of Women's and Children's Health, Dunedin, New Zealand.""}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': ""Department of Women's and Children's Health, Dunedin, New Zealand.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': ""Dunedin School of Medicine Dean's Office, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, Dunedin, New Zealand.'}]",International journal of obesity (2005),['10.1038/s41366-019-0432-y'] 3173,31811383,Comparison of two routes in nasal passage for transnasale flexible fiberoptic laryngoscopy.,"PURPOSE Present study compares two routes in nasal passage for transnasal flexible fiberoptic laryngoscopy (TNFFL). METHODS Included in the study were 60 patients who were split equally into Group 1 and Group 2 and all underwent TNFFL. The tip of endoscope was introduced between the septum and inferior turbinate along the nasal floor in Group 1 and between the inferior turbinate and middle turbinate in Group 2. O 2 saturation, heart rate, systolic blood pressure, diastolic blood pressure of patients were taken 30 min before and immediately after procedure. Patients were asked to rate the pain-irritation, gag reflex, dyspnea they experienced during procedure using visual analogue scale. Two routes were compared in terms of physiological effects and patient comfort. RESULTS No statistically significant difference was found between two groups in terms of physiological effects or patient comfort. When values recorded immediately after procedure were compared with baseline values, a significant decrease was observed in O 2 saturation and heart rate in Group 1 and Group 2, respectively. No clinically detectable symptoms were observed in the patients. CONCLUSION Decreases in O 2 saturation and heart rate may be regarded as physiological effects of TNFFL. No significant difference between two routes was noted in the present study in terms of physiological effects and patient comfort during TNFFL. Introducing the endoscope between the inferior and middle turbinates may be a comfortable and safe option, particularly if the endoscope cannot be advanced along the nasal floor due to septum deviation, septal crest, inferior turbinate hypertrophy.",2020,No significant difference between two routes was noted in the present study in terms of physiological effects and patient comfort during TNFFL.,['Included in the study were 60 patients who were split equally into Group 1 and Group 2 and all underwent'],"['TNFFL', 'transnasal flexible fiberoptic laryngoscopy (TNFFL']","['O 2 saturation and heart rate', 'O 2 saturation, heart rate, systolic blood pressure, diastolic blood pressure', 'physiological effects or patient comfort', 'pain-irritation, gag reflex, dyspnea they experienced during procedure using visual analogue scale', 'physiological effects and patient comfort']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0521131', 'cui_str': 'Transnasal approach (qualifier value)'}, {'cui': 'C0702149', 'cui_str': 'Flexible fiberoptic laryngoscopy'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0585033', 'cui_str': 'During procedure (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.0281146,No significant difference between two routes was noted in the present study in terms of physiological effects and patient comfort during TNFFL.,"[{'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Cengiz', 'Affiliation': 'Ear Nose and Throat Department, Yozgat Bozok University, Yozgat, Turkey. cyhncngz@gmail.com.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Şahin', 'Affiliation': 'Ear Nose and Throat Department, Yozgat Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Dağıstan', 'Affiliation': 'Ear Nose and Throat Department, Yozgat Bozok University, Yozgat, Turkey.'}, {'ForeName': 'İlknur Haberal', 'Initials': 'İH', 'LastName': 'Can', 'Affiliation': 'Ear Nose and Throat Department, Yozgat Bozok University, Yozgat, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05753-6'] 3174,32088913,Clinical Effectiveness of Levetiracetam Compared to Fosphenytoin in the Treatment of Benzodiazepine Refractory Convulsive Status Epilepticus.,"OBJECTIVES To determine whether levetiracetam is an alternative to fosphenytoin to control Benzodiazepine Refractory Status Epilepticus (BRSE) in pediatric population and also to compare the acute drug related side-effects and ventilation requirement among the both arms of anti-epileptic drug therapy. METHODS All consecutive children admitted with BRSE were randomized to group A, who received fosphenytoin at 20 mg/kg phenytoin equivalents (PE) dose and group B who received levetiracetam at 40 mg/kg over 10 min. Time to terminate seizure (response latency) was measured. If seizure remained refractory after 20 min of test drug administration, appropriate drug escalation was made according to pediatrician's discretion. All primary and secondary outcome measures were compared between the two therapeutic groups. RESULTS Of 61 children enrolled over 18 mo period, 29 (47.5%) were randomized to group A and 32 (52.5%) were randomized to Group B. Baseline characteristics were comparable between the two groups. Among 61 children, 58(98%) required Pediatric Intensive Care Unit (PICU) admission and among those 5(8.2%) children required mechanical ventilation. Duration of PICU stay, hospital stay, the response latency and seizure recurrence were compared between both groups. Significant number of children received additional anti-epileptic drugs (AEDs) in fosphenytoin group [9/29(31%)] compared to levetiracetam group [2/32(7%)] to control seizure. CONCLUSIONS Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.",2020,"CONCLUSIONS Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.","['All consecutive children admitted with BRSE', '61 children, 58(98%) required Pediatric Intensive Care Unit (PICU) admission and among those 5(8.2%) children required mechanical ventilation', 'Benzodiazepine Refractory Convulsive Status Epilepticus', '61 children enrolled over 18 mo period, 29 (47.5%) were randomized to group A and 32 (52.5']","['levetiracetam', 'Levetiracetam', 'fosphenytoin at 20\xa0mg/kg phenytoin equivalents (PE) dose and group B who received levetiracetam at 40\xa0mg/kg over 10\xa0min', 'Fosphenytoin']","['Duration of PICU stay, hospital stay, the response latency and seizure recurrence', 'Time to terminate seizure (response latency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3536587', 'cui_str': 'Convulsive status epilepticus, refractory'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",61.0,0.169166,"CONCLUSIONS Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.","[{'ForeName': 'Sricharantheja', 'Initials': 'S', 'LastName': 'Nalisetty', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sasidaran', 'Initials': 'S', 'LastName': 'Kandasamy', 'Affiliation': 'Advanced Pediatric Critical Care Center, Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, 600031, India. sasidarpgi@gmail.com.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Sridharan', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Vimalraj', 'Initials': 'V', 'LastName': 'Vijayakumar', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Thangavelu', 'Initials': 'T', 'LastName': 'Sangaralingam', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Nedunchelian', 'Initials': 'N', 'LastName': 'Krishnamoorthi', 'Affiliation': 'Department of Research & Academics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03221-2'] 3175,32087175,"Negative pressure wound therapy versus standard treatment in patients with acute conflict-related extremity wounds: a pragmatic, multisite, randomised controlled trial.","BACKGROUND In armed conflict, injuries among civilians are usually complex and commonly affect the extremities. Negative pressure wound therapy (NPWT) is an alternative to standard treatment of acute conflict-related extremity wounds. We aimed to compare the safety and effectiveness of NPWT with that of standard treatment. METHODS In this pragmatic, randomised, controlled superiority trial done at two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury. Participants were assigned (1:1) to receive either NPWT or standard treatment. We used a predefined, computer-generated randomisation list with three block sizes. Participants and their treating physicians were not masked to treatment allocation. The primary endpoint was wound closure by day 5. The coprimary endpoint was net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02444598, and is closed to accrual. FINDINGS Between June 9, 2015, and Oct 24, 2018, 174 patients were randomly assigned to either the NPWT group (n=88) or the standard treatment group (n=86). Five patients in the NPWT group and four in the standard treatment group were excluded from the intention-to-treat analysis. By day 5, 41 (49%) of 83 participants in the NPWT group and 49 (60%) of 82 participants in the standard treatment group had closed wounds, with an absolute difference of 10 percentage points (95% CI -5 to 25, p=0·212; risk ratio [RR] 0·83, 95% CI 0·62 to 1·09). Net clinical benefit was seen in 33 (41%) of 81 participants in the NPWT group and 34 (44%) of 78 participants in the standard treatment group, with an absolute difference of 3 percentage points (95% CI -12 to 18, p=0·750; RR 0·93, 95% CI 0·65 to 1·35). There was one in-hospital death in the standard treatment group and none in the NPWT group. The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups. INTERPRETATION NPWT did not yield superior clinical outcomes compared with standard treatment for acute conflict-related extremity wounds. The results of this study not only question the use of NPWT, but also question the tendency for new and costly treatments to be introduced into resource-limited conflict settings without supporting evidence for their effectiveness. This study shows that high-quality, randomised trials in challenging settings are possible, and our findings support the call for further research that will generate context-specific evidence. FUNDING The Stockholm County Council, the Swedish National Board of Health and Welfare, and Médecins Sans Frontières.",2020,"The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups. ","['Between June 9, 2015, and Oct 24, 2018', 'patients with acute conflict-related extremity wounds', '174 patients', 'two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury']","['NPWT or standard treatment', 'Negative pressure wound therapy versus standard treatment', 'NPWT', 'Negative pressure wound therapy (NPWT']","['Net clinical benefit', 'net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb', 'hospital death', 'wound closure by day 5', 'proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation', 'closed wounds', 'safety and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C0679319', 'cui_str': 'Closed wound (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",174.0,0.178865,"The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups. ","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Älgå', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden; Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. Electronic address: andreas.alga@ki.se.'}, {'ForeName': 'Rawand', 'Initials': 'R', 'LastName': 'Haweizy', 'Affiliation': 'College of Medicine, Hawler Medical University, Erbil, Iraq.'}, {'ForeName': 'Khaldoon', 'Initials': 'K', 'LastName': 'Bashaireh', 'Affiliation': 'Department of Special Surgery, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Médecins Sans Frontières, Operational Centre Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Kalle Conneryd', 'Initials': 'KC', 'LastName': 'Lundgren', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'von Schreeb', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Malmstedt', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30547-9'] 3176,31650354,Effect of nutritional supplement based on melatonin on the intraocular pressure in normotensive subjects.,"PURPOSE To evaluate the effect of a new nutritional supplement based on melatonin on the intraocular pressure (IOP) in normotensive subjects. PATIENTS AND METHODS A short-term prospective study was designed. Sixty-seven normotensive subjects were recruited. Patients were divided into two groups. The daily group (DG) (n = 18) was instructed to take the supplement between 22:00 and 23:00 (before sleeping) for 3 consecutive days. IOP was measured from 10.00 to 11.00 am the day before treatment and during the 3 days of experiment. The acute group (AG) (n = 49) was instructed to take the supplement after the second measure (11.00) of the second day. IOP was measured 1 h and just before the intake of the supplement and 1 and 2 h after. All measurements in this group were taken 1 day before without any supplement (control) and the day of experiment. RESULTS The DG group showed a significant decrease in IOP after supplement intake in all days of experiment, from 14.9 ± 3.4 mm Hg to 13.8 ± 2.9 mm Hg after 3 days of experiment (p value < 0.001). For AG, IOP did not change during the control day; however, a reduction of 1 mm Hg was found 2 and 3 h after supplement intake, from 15.7 ± 2.5 mm Hg to 14.7 ± 2.5 mm Hg and 15.1 ± 2.7 mm Hg, respectively, being statistically significant (p value < 0.001). CONCLUSION The supplement based on melatonin was able to reduce the IOP in normotensive subjects after 2 h of intake. Moreover, the daily intake showed a reduction in IOP during the 3 days of experiment.",2020,"For AG, IOP did not change during the control day; however, a reduction of 1 mm ","['normotensive subjects', 'Sixty-seven normotensive subjects', 'normotensive subjects after 2\xa0h of intake']","['nutritional supplement based on melatonin', 'melatonin', 'new nutritional supplement based on melatonin']","['IOP', 'intraocular pressure (IOP', 'intraocular pressure']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",67.0,0.0210027,"For AG, IOP did not change during the control day; however, a reduction of 1 mm ","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Carracedo-Rodríguez', 'Affiliation': 'Ocupharm Diagnostics Group Research, Faculty of Optic and Optometry, Department of Optometry and Vision, University Complutense of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain. jgcarrac@ucm.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Águila', 'Affiliation': 'Avizor S.A., Madrid, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Rodriguez-Pomar', 'Affiliation': 'Avizor S.A., Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bodas-Romero', 'Affiliation': 'Ocupharm Diagnostics Group Research, Faculty of Optic and Optometry, Department of Optometry and Vision, University Complutense of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sanchez-Naves', 'Affiliation': 'Ocupharm Diagnostics Group Research, Faculty of Optic and Optometry, Department of Optometry and Vision, University Complutense of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Pintor', 'Affiliation': 'Ocupharm Diagnostics Group Research, Faculty of Optic and Optometry, Department of Optometry and Vision, University Complutense of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain.'}]",International ophthalmology,['10.1007/s10792-019-01199-1'] 3177,31743136,Electrocardiographic Effects of Propofol versus Etomidate in Patients with Brugada Syndrome.,"BACKGROUND Brugada Syndrome is an inherited arrhythmogenic disease, characterized by the typical coved type ST-segment elevation in the right precordial leads from V1 through V3. The BrugadaDrugs.org Advisory Board recommends avoiding administration of propofol in patients with Brugada Syndrome. Since prospective studies are lacking, it was the purpose of this study to assess the electrocardiographic effects of propofol and etomidate on the ST- and QRS-segments. In this trial, it was hypothesized that administration of propofol or etomidate in bolus for induction of anesthesia, in patients with Brugada Syndrome, do not clinically affect the ST- and QRS-segments and do not induce arrhythmias. METHODS In this prospective, double-blinded trial, 98 patients with established Brugada syndrome were randomized to receive propofol (2 to 3 mg/kg) or etomidate (0.2 to 0.3 mg/kg) for induction of anesthesia. The primary endpoints were the changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia. RESULTS The analysis included 80 patients: 43 were administered propofol and 37 etomidate. None of the patients had a ST elevation greater than or equal to 0.2 mV, one in each group had a ST elevation of 0.15 mV. An ST depression up to -0.15mV was observed eleven times with propofol and five with etomidate. A QRS-prolongation of 25% upon induction was seen in one patient with propofol and three with etomidate. This trial failed to establish any evidence to suggest that changes in either group differed, with most percentiles being zero (median [25th, 75th], 0 [0, 0] vs. 0 [0, 0]). Finally, no new arrhythmias occurred perioperatively in both groups. CONCLUSIONS In this trial, there does not appear to be a significant difference in electrocardiographic changes in patients with Brugada syndrome when propofol versus etomidate were administered for induction of anesthesia. This study did not investigate electrocardiographic changes related to propofol used as an infusion for maintenance of anesthesia, so future studies would be warranted before conclusions about safety of propofol infusions in patients with Brugada syndrome can be determined.",2020,"The primary endpoints were the changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia. ","['patients with Brugada syndrome', '98 patients with established Brugada syndrome', '80 patients: 43 were administered', 'Patients with Brugada Syndrome', 'n = 43) versus', 'n = 37) for induction of general anesthesia', 'patients with Brugada Syndrome']","['propofol and etomidate', 'etomidate', 'propofol and 37 etomidate', 'propofol or etomidate', 'Etomidate', 'propofol', 'propofol versus etomidate', 'Propofol']","['electrocardiographic changes', 'changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia', 'ST depression', 'electrocardiographic effects', 'Electrocardiographic Effects', 'ST elevation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1142166', 'cui_str': 'Sudden Unexplained Death Syndrome'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}]",98.0,0.0321962,"The primary endpoints were the changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia. ","[{'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Flamée', 'Affiliation': 'From the Department of Anesthesiology and Perioperative Medicine (P.F., H.C., J.T.B., S.B., V.U., C.V., P.F., J.P.) the Heart Rhythm Management Center, Center of Heart and Vascular Disease (V.V., W.D., G-B.,C., P.B., C.d.A.), University Hospital Brussels the Interfaculty Center Data processing & Statistics (W.C.), Free University Brussels, Laarbeeklaan, Brussels, Belgium.'}, {'ForeName': 'Varnavas', 'Initials': 'V', 'LastName': 'Varnavas', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dewals', 'Affiliation': ''}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Carvalho', 'Affiliation': ''}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Cools', 'Affiliation': ''}, {'ForeName': 'Jigme Tshering', 'Initials': 'JT', 'LastName': 'Bhutia', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beckers', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Umbrain', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Verborgh', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': ''}, {'ForeName': 'Gian-Battista', 'Initials': 'GB', 'LastName': 'Chierchia', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Brugada', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Poelaert', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'de Asmundis', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003030'] 3178,31367728,Frailty and Brain-Muscle Correlates in Older People With Type 2 Diabetes: A structural-MRI Explorative Study.,"OBJECTIVES Muscle alterations, mainly functional alterations are frequently observed in older people with type 2 diabetes (T2DM). Sarcopenia may be one mechanism of transition to frailty in these people. Thus, we aim to explore the characteristics of muscle and its association with cerebral grey matter volumes within this group. METHODS Single center study nested within the international MID-Frail (a randomized clinical trial to evaluate the effectiveness of a multi-modal intervention in older people with T2DM on frailty and quality of life) trial participants underwent both brain and muscle T1 MRI, nutritional and functional assessments. Muscle areas were measured in rectus femoris (RF). Relationships between MRI grey matter volumes and muscle areas or function tests were described using positive and negative regressions. RESULTS Twenty-six subjects (7 female, mean age 78.2 y, SD 5.0), 6 frail and 20 pre-frail were explored in this sub-study. Frail subjects had lower Mini Nutritional Assessment (MNA), Short Physical Performance Battery (SPPB), hip flexor strength than pre-frail ones but similar BMI and balance. Total SPPB was positively related with hip flexor strength and maximal RF area. Balance SPPB sub-score was unrelated to strength or RF area. MNA score was correlated with hip flexor strength and to global grey matter but not to SPPB. Hip flexor strength was correlated with grey matter areas involved in motor control. Walking time was negatively and rising chair sub-score was positively associated with grey matter volumes of motor areas. CONCLUSIONS Sarcopenia features were more frequent in frail than prefrail subjects and were associated with decrease in grey matter volumes involved in motor control.",2019,"Frail subjects had lower Mini Nutritional Assessment (MNA),","['Single center study nested within the international MID-Frail', 'older people with type 2 diabetes (T2DM', 'Frail subjects', 'older people with T2DM on frailty and quality of life', 'Twenty-six subjects (7 female, mean age 78.2 y, SD 5.0), 6 frail and 20 pre-frail', 'Older People With Type 2 Diabetes']",['multi-modal intervention'],"['hip flexor strength and maximal RF area', 'lower Mini Nutritional Assessment (MNA', 'Short Physical Performance Battery (SPPB), hip flexor strength', 'grey matter volumes', 'Total SPPB', 'Balance SPPB sub-score', 'MNA score', 'hip flexor strength', 'Hip flexor strength', 'Walking time']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0034380'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",26.0,0.0279143,"Frail subjects had lower Mini Nutritional Assessment (MNA),","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bourdel-Marchasson', 'Affiliation': 'I Bourdel-Marchasson, CNRS/Université de Bordeaux, UMR 5536 Résonance Magnétique des systèmes Biologiques, Bordeaux, France, isabelle.bourdel-marchasson@chu-bordeaux.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Catheline', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Regueme', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Danet-Lamasou', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Barse', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ratsimbazafy', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rodriguez-Manas', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1229-3'] 3179,32078754,The Effect of Reflexology on Lactation and Postpartum Comfort in Caesarean-Delivery Primiparous Mothers: A Randomized Controlled Study.,"AIM This study aimed to investigate the effect of reflexology on lactation and postpartum comfort in primiparas giving births through caesarean section. METHODS This randomized controlled trial was conducted in 100 women with first birth through caesarean section between May 2016 and May 2017. Expectant mothers were randomly included into an intervention and a control group. The intervention group consisted of mothers in whom reflexology was performed three times per day at every eight hours for 30 min for 3 days. RESULTS The mean scores of the breastfeeding chart system and breastfeeding satisfaction scores of the mothers in the intervention group were significantly higher than those of the controls, and the first lactation period of the mothers in the intervention group was shorter than that of the controls. Mean breast-tension, breast-heat, and breast-pain scores were similar in both groups on day 1; however, a significant increase was seen the intervention group on days 2 and 3, compared to those in the controls. The mean scores of the Postpartum Comfort Questionnaire in the intervention group were significantly better than those of the controls. CONCLUSIONS Reflexology starts lactation earlier in mothers giving birth via caesarean section, supports the breastfeeding period, and increases mothers' postpartum comfort.",2020,"The mean scores of the breastfeeding chart system and breastfeeding satisfaction scores of the mothers in the intervention group were significantly higher than those of the controls, and the first lactation period of the mothers in the intervention group was shorter than that of the controls.","['Expectant mothers', 'primiparas giving births through caesarean section', 'Caesarean-Delivery Primiparous Mothers', '100 women with first birth through caesarean section between May 2016 and May 2017']","['Reflexology', 'reflexology']","['mean scores of the breastfeeding chart system and breastfeeding satisfaction scores', 'mean scores of the Postpartum Comfort Questionnaire', 'Lactation and Postpartum Comfort', 'Mean breast-tension, breast-heat, and breast-pain scores']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016145', 'cui_str': 'First Birth'}]","[{'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C1142383', 'cui_str': 'Breast tension'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}]",100.0,0.0258874,"The mean scores of the breastfeeding chart system and breastfeeding satisfaction scores of the mothers in the intervention group were significantly higher than those of the controls, and the first lactation period of the mothers in the intervention group was shorter than that of the controls.","[{'ForeName': 'Seyhan', 'Initials': 'S', 'LastName': 'Çankaya', 'Affiliation': 'Department of Midwifery, Health Sciences Faculty of Selcuk University, Konya, Turkey.'}, {'ForeName': 'Gülay', 'Initials': 'G', 'LastName': 'Ratwisch', 'Affiliation': 'Department of Gynecologic and Obstetrics Nursing, Florence Nightingale Nursing Faculty of Istanbul University, Istanbul, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12824'] 3180,32083679,An Observational Study of Thermometer Use by Consumers When Preparing Ground Turkey Patties.,"ABSTRACT The purpose of this study was to test the effectiveness of an intervention for consumer thermometer use by using a randomized experimental design and direct observation of meal preparation. The study was conducted in test kitchen facilities in two locations in North Carolina (one urban and one rural). Cameras recorded participants' actions at various locations throughout the kitchen and recorded the meal preparation from beginning to end. Before preparing the meal, a randomized treatment group watched a 3-min U.S. Department of Agriculture (USDA) food safety video ""The Importance of Cooking to a Safe Internal Temperature and How to Use a Food Thermometer."" Participants in the control and treatment groups were observed while cooking turkey burgers and preparing a salad to determine whether a thermometer was used to check the doneness of the turkey patties. Following meal preparation, all participants responded to a postobservation interview about food handling behaviors. Treatment group participants were also asked about the intervention. A total of 383 people participated in the study (201 in the control group and 182 in the treatment group). Participants who viewed the video were twice as likely to use a thermometer to check the doneness of the turkey patties compared with the participants who were not exposed to the video (75 versus 34%) and twice as likely to place the thermometer in the correct location (52 versus 23%). Sixty-seven percent of participants who watched the video reported that it influenced their behavior in the kitchen. This study demonstrates the importance of timing and framing of a behavioral intervention for thermometer use and highlights considerations for the development of additional messages (e.g., proper insertion). HIGHLIGHTS ",2020,Participants who viewed the video were twice as likely to use a thermometer to check the doneness of the turkey patties compared with those who were not exposed to the video (75 vs. 34%) and twice as likely to place the thermometer in the correct location (52 vs. 23%).,"['383 people participated in the study (201 control, 182 treatment', 'test kitchen facilities located in two locations in North Carolina (one urban and one rural']","['3-minute United States Department of Agriculture (USDA) food safety video ""The Importance of Cooking to a Safe Internal Temperature and How to Use a Food Thermometer"" ( https://www.youtube.com/watch?v=-2KkV2yFiN0 ']",[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0557653', 'cui_str': 'Kitchen (environment)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0039818', 'cui_str': 'Thermometers'}]",[],383.0,0.0399865,Participants who viewed the video were twice as likely to use a thermometer to check the doneness of the turkey patties compared with those who were not exposed to the video (75 vs. 34%) and twice as likely to place the thermometer in the correct location (52 vs. 23%).,"[{'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Duong', 'Affiliation': 'Department of Food, Bioprocessing, and Nutrition Sciences, North Carolina State University, Raleigh, North Carolina 27607.'}, {'ForeName': 'Ellen Thomas', 'Initials': 'ET', 'LastName': 'Shumaker', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina 27709 (ORCID: https://orcid.org/0000-0002-0113-4321 [E.T.S.]).'}, {'ForeName': 'Sheryl C', 'Initials': 'SC', 'LastName': 'Cates', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina 27709 (ORCID: https://orcid.org/0000-0002-0113-4321 [E.T.S.]).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shelley', 'Affiliation': 'Department of Agricultural and Human Sciences, North Carolina State University, Raleigh, North Carolina 27607.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Goodson', 'Affiliation': 'Department of Agricultural and Human Sciences, North Carolina State University, Raleigh, North Carolina 27607.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bernstein', 'Affiliation': 'U.S. Department of Agriculture, Food Safety and Inspection Service, Office of Public Affairs and Consumer Education, Washington, DC 20250, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lavallee', 'Affiliation': 'U.S. Department of Agriculture, Food Safety and Inspection Service, Office of Public Affairs and Consumer Education, Washington, DC 20250, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kirchner', 'Affiliation': 'Department of Food, Bioprocessing, and Nutrition Sciences, North Carolina State University, Raleigh, North Carolina 27607.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Goulter', 'Affiliation': 'Department of Food, Bioprocessing, and Nutrition Sciences, North Carolina State University, Raleigh, North Carolina 27607.'}, {'ForeName': 'Lee-Ann', 'Initials': 'LA', 'LastName': 'Jaykus', 'Affiliation': 'Department of Food, Bioprocessing, and Nutrition Sciences, North Carolina State University, Raleigh, North Carolina 27607.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chapman', 'Affiliation': 'Department of Agricultural and Human Sciences, North Carolina State University, Raleigh, North Carolina 27607.'}]",Journal of food protection,['10.4315/JFP-19-594'] 3181,31283920,Patient-Level Trajectories and Outcomes After Low-Dose CT Screening in the National Lung Screening Trial.,"BACKGROUND Shared decision-making is an essential element of low-dose CT (LDCT) screening for lung cancer. Understanding patient-level outcomes from the National Lung Screening Trial (NLST) is critical to effectively communicate risks and benefits of screening to patients. METHODS We performed a secondary analysis of data collected in the NLST. We determined outcomes of each LDCT scan performed in the NLST (downstream evaluation, complications, lung cancer diagnoses), and compared outcomes at the test level with outcomes calculated at the patient level for those randomized to LDCT screening. To assess the impact of COPD on patient outcomes, we compared outcomes among patients with and without COPD. RESULTS Of 75,138 LDCT scans, 14.2% led to a diagnostic study and 1.5% to an invasive procedure, with 0.3% of LDCT scans resulting in a procedure-related complication and 0.1% in a serious complication. Among 24,453 patients who underwent LDCT screening, 30.5% underwent a diagnostic study and 4.2% an invasive procedure, with 0.9% of screened patients experiencing a procedure-related complication and 0.3% a serious complication. Patients with COPD (defined by self-report) were more likely to need a diagnostic study (adjusted OR [aOR], 1.29; P < .01) and an invasive procedure (aOR, 1.41; P < .01) and more likely to experience a complication (aOR, 1.83; P < .01) and a serious complication (aOR, 1.78; P = .01). Patients with COPD also were more likely to be diagnosed with lung cancer (aOR, 1.43; P < .01). CONCLUSIONS We provide important patient-level data from the NLST that can be used to guide shared decision-making. The risk-to-benefit ratio of screening may vary significantly in some patients, such as those with COPD, in whom both risks and benefits of screening may be increased.",2019,"Patients with COPD also were more likely to be diagnosed with lung cancer (aOR 1.43, p<0.01). ","['patients with and without COPD', '24,453 patients who underwent']","['computed tomography (LDCT) screening', 'LDCT screening']","['invasive procedure', 'serious complication', 'diagnosed with lung cancer', 'NLST (downstream evaluation, complications, lung cancer diagnoses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.0926638,"Patients with COPD also were more likely to be diagnosed with lung cancer (aOR 1.43, p<0.01). ","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Iaccarino', 'Affiliation': 'Pulmonary Center, Boston University School of Medicine, Boston, MA. Electronic address: jmi@bu.edu.'}, {'ForeName': 'Gerard A', 'Initials': 'GA', 'LastName': 'Silvestri', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Renda Soylemez', 'Initials': 'RS', 'LastName': 'Wiener', 'Affiliation': 'Pulmonary Center, Boston University School of Medicine, Boston, MA; Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA.'}]",Chest,['10.1016/j.chest.2019.06.016'] 3182,32045493,"Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects.","AIMS This investigation characterised tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 antibody TAK-079. METHODS A randomised, double-blind, placebo-controlled trial of a single intravenous (i.v.) infusion or subcutaneous (s.c.) injection of TAK-079 at escalating doses in healthy subjects (n = 74), who were followed for 92 days postexposure. RESULTS TAK-079 was well tolerated. All adverse events were mild or moderate. There were no withdrawals, infusion, or injection site reactions over the tested i.v. and s.c. doses up to 0.06 and 0.6 mg kg -1 , respectively. At higher doses, transient cytokine level increases, following i.v. administration, coincided with reduction in CD38-expressing cells; clinical symptoms included mild pyrexia, headache, and postural hypotension. Following an i.v. infusion of 0.06 mg kg -1 TAK-079, maximum observed serum concentration (C max ) was 100.4 (%CV: 52) ng mL -1 , time to C max was the end of infusion and natural killer (NK_ cells were reduced 93.8 (±8.5) % from baseline levels. Following a s.c. injection of 0.6 mg kg -1 TAK-079, C max was 23.0 (%CV: 67) ng mL -1 with time to C max of 24 (range 7.98-96.02) hours, and plasmablasts were subsequently reduced 93.4 (±8.8) % from predose levels. Serum immunoglobulin (Ig)M, IgA and IgG levels were reduced by 15-60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c. Reductions in NK cells at 0.6 mg kg -1 s.c. were approximately 2-3 times more durable than at 0.06 mg kg -1 i.v. CONCLUSIONS TAK-079 was well tolerated and s.c. administration elicited more durable reductions in plasmablasts and NK cells. This plasmacytolytic profile could be useful for treating disorders caused by plasma or NK cells, malignant counterparts, and/or pathogenic antibodies.",2020,"Serum IgM, IgA and IgG levels were reduced by 15% to 60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c.","['Healthy Subjects', 'healthy subjects (n=74']","['placebo', 'TAK-079', 'single intravenous (i.v.) infusion or subcutaneous (s.c']","['CD38-expressing cells; clinical symptoms included mild pyrexia, headache, and postural hypotension', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Anti-CD38 Cytolytic Antibody TAK-079', 'durable reductions in plasmablasts and NK cells', 'Serum IgM, IgA and IgG levels', 'tolerated', 'transient cytokine level', 'Reductions in NK cells']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0239574', 'cui_str': 'Low grade fever'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.468853,"Serum IgM, IgA and IgG levels were reduced by 15% to 60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c.","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Fedyk', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Annelize', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Parexel, Harrow, UK.'}, {'ForeName': 'Glennda', 'Initials': 'G', 'LastName': 'Smithson', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Estevam', 'Affiliation': 'Takeda Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Gezim', 'Initials': 'G', 'LastName': 'Lahu', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepcke', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Jianchang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Takeda Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Lachy', 'Initials': 'L', 'LastName': 'Mclean', 'Affiliation': 'Takeda California, San Diego, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14241'] 3183,32081221,Avoiding Bladder Catheters During Atrial Fibrillation Ablation.,"OBJECTIVES This study sought to determine if atrial fibrillation (AF) ablation can be performed safely without bladder catheterization. BACKGROUND Patients undergoing AF ablation often receive bladder catheters. Catheterization is associated with potential complications. The ABCD-AF (Avoiding Bladder Catheters During Atrial Fibrillation) ablation study evaluates the advantages of performing AF ablation without routine catheterization. METHODS In this single-center, prospective, randomized controlled trial, 80 patients received bladder catheterization (group A), and 80 patients received only as-needed catheterization (group B). The primary endpoint was a composite of cystitis, urethral injury, hematuria, dysuria, or urinary retention. RESULTS The mean patient age was 63 ± 13 years, and 33% of patients were female. The primary outcome was reached in 45 patients in group A and 11 patients in group B (p < 0.001). Urinary tract infection occurred in 7 patients in group A and 2 patients in group B (p = 0.17). Urinary retention occurred in 12 patients in group A and 5 patients in group B (p = 0.07). Randomization to catheterization carried an odds ratio of 8.1 (95% confidence interval [CI]: 3.7 to 17.5; p < 0.001), and male sex carried an odds ratio of 3.8 (95% CI: 1.7 to 8.6; p = 0.001) for the primary endpoint. On subgroup analysis, randomization to undergo catheterization had no association with the primary outcome in female patients but had an odds ratio of 14.6 (95% CI: 5.6 to 38.1; p < 0.001) in male patients. In multivariable analysis, sex and catheter status remained independently associated with the primary outcome. CONCLUSIONS Bladder catheterization can be safely avoided in patients undergoing AF ablation and is associated with a significant reduction in adverse outcomes, especially in men.",2020,Urinary tract infection occurred in 7 patients in group A and 2 patients in group B (p = 0.17).,"['80 patients received', 'Patients undergoing AF ablation often receive bladder catheters', 'patients undergoing AF ablation', 'The mean patient age was 63 ± 13 years, and 33% of patients were female']","['Bladder Catheters', 'atrial fibrillation (AF) ablation', 'bladder catheterization', 'AF ablation without routine catheterization', 'Bladder catheterization']","['composite of cystitis, urethral injury, hematuria, dysuria, or urinary retention', 'Urinary tract infection', 'Urinary retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1970989', 'cui_str': 'Insertion of catheter into urinary bladder'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0403701', 'cui_str': 'Injury of urethra (disorder)'}, {'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",80.0,0.162444,Urinary tract infection occurred in 7 patients in group A and 2 patients in group B (p = 0.17).,"[{'ForeName': 'Asim S', 'Initials': 'AS', 'LastName': 'Ahmed', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Brad A', 'Initials': 'BA', 'LastName': 'Clark', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Sandeep A', 'Initials': 'SA', 'LastName': 'Joshi', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Girish V', 'Initials': 'GV', 'LastName': 'Nair', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Benzy J', 'Initials': 'BJ', 'LastName': 'Padanilam', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana.'}, {'ForeName': 'Parin J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'St. Vincent Medical Group, St. Vincent Hospital, Indianapolis, Indiana. Electronic address: parin.patel@ascension.org.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.10.003'] 3184,31367733,"Positive Effects of ""Textured Lunches"" Gatherings and Oral Exercises Combined with Physical Exercises on Oral and Physical Function in Older Individuals: A Cluster Randomized Controlled Trial.","OBJECTIVES Proper nutrition and physical exercises are essential to prevent frailty in older adults. Proper masticatory performance and oral function may influence on physical activities as well since the mouth is the entrance of nutrition and digestion. Thus, the present study aimed to test the combined program of specially devised lunch gatherings containing textured foods with oral and physical exercises on the improvement of oral and physical function in community-dwelling older adults. DESIGN A Cluster randomized controlled trial; Setting and Participants: Eighty-six community-dwelling older adults in Daito city, Japan, were randomly assigned into control (n = 43) or intervention (n = 43) groups. INTERVENTION The control group performed the physical exercise regimen only. The intervention group participated in a 12-week physical and oral exercise program and ate a so-called ""munchy lunch"" that introduced textured foods with proper nutrients together after performing the physical exercise twice a week following brief dietary instruction at the intervention onset. Physical training and lunch gatherings were held at local public centers. MEASUREMENTS The differences in measured variables for physical and oral function between baseline and 12 weeks of intervention were statistically tested. RESULTS Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group. Physical properties and activities, including body fat percentage and results of the timed up and go test, decreased more significantly in the intervention group than in controls (p<0.05). CONCLUSIONS Our findings suggest that a combined program of textured lunch gatherings with oral and physical exercises may improve physical and oral function as a preventative approach for frailty in community-dwelling older adults.",2019,"RESULTS Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group.","['older adults', 'community-dwelling older adults', 'Older Individuals', 'Participants: Eighty-six community-dwelling older adults in Daito city, Japan']","['physical exercise regimen', 'Textured Lunches"" Gatherings and Oral Exercises Combined with Physical Exercises', '12-week physical and oral exercise program and ate a so-called ""munchy lunch"" that introduced textured foods with proper nutrients together after performing the physical exercise', 'Physical training and lunch gatherings', 'lunch gatherings containing textured foods with oral and physical exercises', 'oral and physical exercises']","['Oral and Physical Function', 'oral and physical function', 'physical and oral function', 'tongue pressure']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",86.0,0.0258752,"RESULTS Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kito', 'Affiliation': 'Koichiro Matsuo, DDS, PhD, Department of Dentistry and Oral-Maxillofacial Surgery, School of Medicine, Fujita Health University, 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan, Phone: +81-562-93-9098 / Fax: +81-562-93-9098, E-mail: kmatsuo@fujita-hu.ac.jp.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Izumi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kishima', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Itoda', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Masuda', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1216-8'] 3185,32073619,Iron Absorption from Bouillon Fortified with Iron-Enriched Aspergillus oryzae Is Higher Than That Fortified with Ferric Pyrophosphate in Young Women.,"BACKGROUND Bouillon cubes are a potential vehicle for iron fortification. They are currently fortified with ferric pyrophosphate (FePP), which is known to be poorly absorbed. The objective of this study was to assess the iron absorption of Aspergillus oryzae grown in FePP (ASP-p) and compare it with FePP and ferrous sulfate (FeSO4)-fortified bouillon cubes. METHODS In 2 single-blinded, crossover studies, healthy women with serum ferritin concentrations <40 μg/L were randomly assigned to consume a rice-vegetable meal with iron-fortified chicken bouillon. Subjects in study I (n = 17, 18-26 y) consumed iron from both iron sources as 57FePP and 58ASP-p (intrinsically labeled with 58FePP) with a meal containing 4.2 mg of total iron provided for 3 d. Study II (n = 18, 18-29 y) was similar except that subjects consumed 57FeSO4 and 58ASP-p. Whole-blood stable isotope enrichment after 14 d was used to measure fractional iron absorption. Hemoglobin, hematocrit, serum ferritin, hepcidin, and serum C-reactive protein were analyzed at baseline and at 14 d. A t test was used to compare the mean differences in fractional absorptions within each study and baseline characteristics between studies. RESULTS Geometric mean (95% CI) fractional iron absorption of FePP [0.94% (0.63%, 1.40%)] was lower than ASP-p [2.20% (1.47%, 3.30%)] (P < 0.0001) in study I. In study II, ASP-p fractional absorption [2.98% (2.03%, 4.38%)] was lower than that of FeSO4 [9.88% (6.70%, 14.59%)] (P < 0.0001). Both ferritin (r = -0.41, P = 0.014) and hepcidin (r = -0.42, P = 0.01) concentrations were inversely correlated with ASP-p iron absorption. Fractional absorption of ASP-p was also positively correlated with FePP (r = 0.92, P < 0.0001) and FeSO4 (r = 0.52, P < 0.02) absorption. CONCLUSIONS ASP-p-fortified bouillon provided 2.3-fold higher absorbable iron than the currently used FePP. Bouillon fortified with ASP-p may contribute sufficient bioavailable iron to meet the daily iron requirements in young women only if consumed with other iron-fortified staple foods. This trial was registered at clinicaltrials.gov as NCT03586245.",2020,"Fractional absorption of ASP-p was also positively correlated with FePP (r = 0.92, P < 0.0001) and FeSO4 (r = 0.52, P < 0.02) absorption. ","['Subjects in study I (n\xa0', 'young women', 'Young Women', 'healthy women with serum ferritin concentrations <40 μg/L']","['rice-vegetable meal with iron-fortified chicken bouillon', 'ferric pyrophosphate (FePP', 'Fortified with Ferric Pyrophosphate', 'FePP and ferrous sulfate (FeSO4)-fortified bouillon cubes']","['FeSO4', 'hepcidin', 'Hemoglobin, hematocrit, serum ferritin, hepcidin, and serum C-reactive protein', 'fractional iron absorption of FePP', 'Geometric mean', 'ASP-p fractional absorption', 'Fractional absorption of ASP-p']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus domesticus'}, {'cui': 'C0117541', 'cui_str': 'ferric pyrophosphate'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}]","[{'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0206298', 'cui_str': 'European Viper'}]",,0.176089,"Fractional absorption of ASP-p was also positively correlated with FePP (r = 0.92, P < 0.0001) and FeSO4 (r = 0.52, P < 0.02) absorption. ","[{'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Bries', 'Affiliation': 'Department of Food Sciences and Human Nutrition, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Hurrell', 'Affiliation': 'ETH Zürich, Institute of Food, Nutrition, and Health, Zurich, Switzerland.'}, {'ForeName': 'Manju B', 'Initials': 'MB', 'LastName': 'Reddy', 'Affiliation': 'Department of Food Sciences and Human Nutrition, Iowa State University, Ames, IA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa035'] 3186,31856691,Cilostazol Versus Aspirin in Ischemic Stroke Patients With High-Risk Cerebral Hemorrhage: Subgroup Analysis of the PICASSO Trial.,"Background and Purpose- Although cilostazol has shown less hemorrhagic events than aspirin, only marginal difference was observed in hemorrhagic stroke events among patients at high risk for cerebral hemorrhage. To identify patients who would most benefit from cilostazol, this study analyzed interactions between treatment and subgroups of the PICASSO trial (Prevention of Cardiovascular Events in Asian Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage). Methods- Ischemic stroke patients with a previous intracerebral hemorrhage or multiple microbleeds were randomized to treatment with cilostazol or aspirin and followed up for a mean 1.8 years. Efficacy, defined as the composite of any stroke, myocardial infarction, and vascular death, and safety, defined as the incidence of hemorrhagic stroke, were analyzed in the 2 groups. Interactions between treatment and age, sex, presence of hypertension and diabetes mellitus, index of high-risk cerebral hemorrhage, and white matter lesion burden were analyzed for primary and key secondary outcomes. Changes in vital signs and laboratory results were compared in the 2 groups. Results- Among all 1534 patients enrolled, a significant interaction between treatment group and index of high risk for cerebral hemorrhage on hemorrhagic stroke ( P for interaction, 0.03) was observed. Hemorrhagic stroke was less frequent in the cilostazol than in the aspirin group in patients with multiple microbleeds (1 versus 13 events; hazard ratio, 0.08 [95% CI, 0.01-0.61]; P =0.01). A marginal interaction between treatment group and white matter change on any stroke ( P for interaction, 0.08) was observed. Cilostazol reduced any stroke significantly in patients with mild (5 versus 16 events; hazard ratio, 0.36 [95% CI, 0.13-0.97]; P =0.04)-to-moderate (16 versus 32 events; hazard ratio, 0.50 [95% CI, 0.29-0.92]; P =0.03) white matter changes. Heart rate and HDL (high-density lipoprotein) cholesterol level were significantly higher in the cilostazol group than in the aspirin group at follow-up. Conclusions- Cilostazol may be more beneficial for ischemic stroke patients with multiple cerebral microbleeds and before white matter changes are extensive. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01013532.",2020,"Cilostazol reduced any stroke significantly in patients with mild (5 versus 16 events; hazard ratio, 0.36 [95% CI, 0.13-0.97]; P =0.04)-to-moderate (16 versus 32 events; hazard ratio, 0.50 [95% CI, 0.29-0.92]; P =0.03) white matter changes.","['With High-Risk Cerebral Hemorrhage', 'Ischemic stroke patients with a previous intracerebral hemorrhage or multiple microbleeds', '1534 patients enrolled', 'Ischemic Stroke Patients', 'Asian Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage', 'patients at high risk for cerebral hemorrhage', 'ischemic stroke patients with multiple cerebral microbleeds']","['Methods', 'cilostazol or aspirin', 'Cilostazol', 'Cilostazol Versus Aspirin', 'cilostazol', 'aspirin', ' and Purpose', 'Conclusions- Cilostazol']","['hemorrhagic stroke events', 'composite of any stroke, myocardial infarction, and vascular death, and safety, defined as the incidence of hemorrhagic stroke', 'Hemorrhagic stroke', 'Heart rate and HDL (high-density lipoprotein) cholesterol level', 'index of high risk for cerebral hemorrhage on hemorrhagic stroke', 'hemorrhagic events']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}]",1534.0,0.0994648,"Cilostazol reduced any stroke significantly in patients with mild (5 versus 16 events; hazard ratio, 0.36 [95% CI, 0.13-0.97]; P =0.04)-to-moderate (16 versus 32 events; hazard ratio, 0.50 [95% CI, 0.29-0.92]; P =0.03) white matter changes.","[{'ForeName': 'Bum Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology, Kyung Hee University Medical Center, Seoul, Korea (B.J.K., S.H.H.).'}, {'ForeName': 'Sun U', 'Initials': 'SU', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology (S.U.K., D.-W.K.), Asan Medical Center, Ulsan University, Seoul, Korea.'}, {'ForeName': 'Joung-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Hanyang University, Myongji Hospital, Seoul, Korea (J.-H.P.).'}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': ""Department of Neurology, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul (Y.-J.K.).""}, {'ForeName': 'Keun-Sik', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Korea (K.-S.H.).'}, {'ForeName': 'Lawrence K S', 'Initials': 'LKS', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong (L.K.S.W.).'}, {'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Anam Hospital (S.Y.), Korea University, Seoul.'}, {'ForeName': 'Yang-Ha', 'Initials': 'YH', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurology, Kyungpook National University Hospital, Daegu, Korea (Y.-H.H.).'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center (J.S.L.), Asan Medical Center, Ulsan University, Seoul, Korea.'}, {'ForeName': 'Juneyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics (J.L.), Korea University, Seoul.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Rha', 'Affiliation': 'Department of Neurology, Inha University Hospital, Incheon, Korea (J.-H.R.).'}, {'ForeName': 'Sung Hyuk', 'Initials': 'SH', 'LastName': 'Heo', 'Affiliation': 'From the Department of Neurology, Kyung Hee University Medical Center, Seoul, Korea (B.J.K., S.H.H.).'}, {'ForeName': 'Seong Hwan', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Chosun University Hospital, Gwangju, Korea (S.H.A.).'}, {'ForeName': 'Woo-Keun', 'Initials': 'WK', 'LastName': 'Seo', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea (W.-K.S.).'}, {'ForeName': 'Jong-Moo', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Eulji General Hospital, Eulji University, Seoul, Korea (J.-M.P.).'}, {'ForeName': 'Ju-Hun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Sacred Heart Hospital, Hallym University, Seoul, Korea (J.-H.L.).'}, {'ForeName': 'Jee-Hyun', 'Initials': 'JH', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Ulsan University Hospital, Ulsan University, Korea (J.-H.K.).'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Dongsan Medical Center, Keimyung University, Daegu, Korea (S.-I.S.).'}, {'ForeName': 'Jin-Man', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Ansan Hospital (J.-M.J.), Korea University, Seoul.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Navarro', 'Affiliation': 'Department of Neurology and Psychiatry, University of Santo Tomas Hospital, Manila, Philippines (J.C.N.).'}, {'ForeName': 'Hahn Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University School of Medicine, Seoul, Korea (H.Y.K.).'}, {'ForeName': 'Eung-Gyu', 'Initials': 'EG', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea (E.-G.K.).'}, {'ForeName': 'Seongheon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Kangwon National University Hospital, Chuncheon, Korea (S.K.).'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Neurology, Dong-A University Hospital, Busan, Korea (J.-K.C.).'}, {'ForeName': 'Man-Seok', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Chonnam National University Medical School, Gwangju, Korea (M.-S.P.).'}, {'ForeName': 'Hyo Suk', 'Initials': 'HS', 'LastName': 'Nam', 'Affiliation': 'Department of Neurology, Yonsei University Severance Hospital, Seoul, Korea (H.S.N.).'}, {'ForeName': 'Dong-Wha', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology (S.U.K., D.-W.K.), Asan Medical Center, Ulsan University, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.023855'] 3187,32075887,Mediterranean diet intervention in overweight and obese subjects lowers plasma cholesterol and causes changes in the gut microbiome and metabolome independently of energy intake.,"OBJECTIVES This study aimed to explore the effects of an isocaloric Mediterranean diet (MD) intervention on metabolic health, gut microbiome and systemic metabolome in subjects with lifestyle risk factors for metabolic disease. DESIGN Eighty-two healthy overweight and obese subjects with a habitually low intake of fruit and vegetables and a sedentary lifestyle participated in a parallel 8-week randomised controlled trial. Forty-three participants consumed an MD tailored to their habitual energy intakes (MedD), and 39 maintained their regular diets (ConD). Dietary adherence, metabolic parameters, gut microbiome and systemic metabolome were monitored over the study period. RESULTS Increased MD adherence in the MedD group successfully reprogrammed subjects' intake of fibre and animal proteins. Compliance was confirmed by lowered levels of carnitine in plasma and urine. Significant reductions in plasma cholesterol (primary outcome) and faecal bile acids occurred in the MedD compared with the ConD group. Shotgun metagenomics showed gut microbiome changes that reflected individual MD adherence and increase in gene richness in participants who reduced systemic inflammation over the intervention. The MD intervention led to increased levels of the fibre-degrading Faecalibacterium prausnitzii and of genes for microbial carbohydrate degradation linked to butyrate metabolism. The dietary changes in the MedD group led to increased urinary urolithins, faecal bile acid degradation and insulin sensitivity that co-varied with specific microbial taxa. CONCLUSION Switching subjects to an MD while maintaining their energy intake reduced their blood cholesterol and caused multiple changes in their microbiome and metabolome that are relevant in future strategies for the improvement of metabolic health.",2020,Significant reductions in plasma cholesterol (primary outcome) and faecal bile acids occurred in the MedD compared with the ConD group.,"['overweight and obese subjects', 'Forty-three participants consumed an MD tailored to their habitual energy intakes (MedD), and 39 maintained their regular diets (ConD', 'Eighty-two healthy overweight and obese subjects with a habitually low intake of fruit and vegetables and a sedentary lifestyle participated', 'subjects with lifestyle risk factors for metabolic disease']","['Mediterranean diet intervention', 'isocaloric Mediterranean diet (MD) intervention']","['urinary urolithins, faecal bile acid degradation and insulin sensitivity', 'faecal bile acids', 'blood cholesterol', 'MD adherence', 'Dietary adherence, metabolic parameters, gut microbiome and systemic metabolome', 'metabolic health, gut microbiome and systemic metabolome', 'plasma cholesterol', 'individual MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0025517', 'cui_str': 'Thesaurismosis'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",43.0,0.0294261,Significant reductions in plasma cholesterol (primary outcome) and faecal bile acids occurred in the MedD compared with the ConD group.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Meslier', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Laiola', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Henrik Munch', 'Initials': 'HM', 'LastName': 'Roager', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Roume', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Quinquis', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Giacco', 'Affiliation': 'Institute of Food Science of CNR, Avellino, Italy.'}, {'ForeName': 'Ilario', 'Initials': 'I', 'LastName': 'Mennella', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Ferracane', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pons', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Pasolli', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rivellese', 'Affiliation': 'Task Force on Microbiome Studies, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it stanislav.ehrlich@inra.fr paola.vitaglione@unina.it.'}, {'ForeName': 'Stanislav Dusko', 'Initials': 'SD', 'LastName': 'Ehrlich', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France ercolini@unina.it stanislav.ehrlich@inra.fr paola.vitaglione@unina.it.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it stanislav.ehrlich@inra.fr paola.vitaglione@unina.it.'}]",Gut,['10.1136/gutjnl-2019-320438'] 3188,32077300,Development of a Wellness Committee Implementation Index for Workplace Health Promotion Programs in Small Businesses.,"PURPOSE To construct a wellness committee (WC) implementation index and determine whether this index was associated with evidence-based intervention implementation in a workplace health promotion program. DESIGN Secondary data analysis of the HealthLinks randomized controlled trial. SETTING Small businesses assigned to the HealthLinks plus WC study arm. SAMPLE Small businesses (20-200 employees, n = 23) from 6 low-wage industries in King County, Washington. MEASURES Wellness committee implementation index (0%-100%) and evidence-based intervention implementation (0%-100%). ANALYSIS We used descriptive and bivariate statistics to describe worksites' organizational characteristics. For the primary analyses, we used generalized estimating equations with robust standard errors to assess the association between WC implementation index and evidence-based intervention implementation over time. RESULTS Average WC implementation index scores were 60% at 15 months and 38% at 24 months. Evidence-based intervention scores among worksites with WCs were 27% points higher at 15 months (64% vs 37%, P < .001) and 36% points higher at 24 months (55% vs 18%, P < .001). Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P < .001). CONCLUSION Wellness committees may play an essential role in supporting evidence-based intervention implementation among small businesses. Furthermore, the degree to which these WCs are engaged and have leadership support, a set plan or goals, and multilevel participation may influence evidence-based intervention implementation and maintenance over time.",2020,"Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P < .001). ","['Small Businesses', 'Small businesses assigned to the HealthLinks plus WC study arm', 'SAMPLE\n\n\nSmall businesses (20-200 employees, n = 23) from 6 low-wage industries in King County, Washington']",[],"['Average WC implementation index scores', 'Higher WC implementation index scores']","[{'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0927082,"Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P < .001). ","[{'ForeName': 'Meagan C', 'Initials': 'MC', 'LastName': 'Brown', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hammerback', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Marlana J', 'Initials': 'MJ', 'LastName': 'Kohn', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Parrish', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Chan', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120906967'] 3189,31315939,Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction.,"OBJECTIVE The Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction - Ischaemic Postconditioning (DANAMI-3-iPOST) did not show improved clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning. However, the use of thrombectomy was frequent and thrombectomy may in itself diminish the effect of ischaemic postconditioning. We evaluated the effect of ischaemic postconditioning in patients included in DANAMI-3-iPOST stratified by the use of thrombectomy. METHODS Patients with STEMI were randomised to conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI. The primary endpoint was a combination of all-cause mortality and hospitalisation for heart failure. RESULTS From March 2011 until February 2014, 1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months. There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004). In patients not treated with thrombectomy (n=520), the primary endpoint occurred in 33 patients (10%) who underwent ischaemic postconditioning (n=326) and in 35 patients (18%) who underwent conventional treatment (n=194) (adjusted hazard ratio (HR) 0.55 (95%confidence interval (CI) 0.34 to 0.89), p=0.016). In patients treated with thrombectomy (n=714), there was no significant difference between patients treated with ischaemic postconditioning (n=291) and conventional PCI (n=423) on the primary endpoint (adjusted HR 1.18 (95% CI 0.62 to 2.28), p=0.62). CONCLUSIONS In this post-hoc study of DANAMI-3-iPOST, ischaemic postconditioning, in addition to primary PCI, was associated with reduced risk of all-cause mortality and hospitalisation for heart failure in patients with STEMI not treated with thrombectomy. TRIAL REGISTRATION NUMBER NCT01435408.",2020,There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004).,"['1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months', 'patients included in DANAMI-3-iPOST stratified by the use of thrombectomy', 'Patients with ST-segment Elevation Myocardial Infarction - Ischaemic Postconditioning (DANAMI-3-iPOST', 'From March 2011 until February 2014', 'patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning', 'patients with ST-elevation myocardial infarction', 'Patients with STEMI']","['ischaemic postconditioning and thrombectomy', 'conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI', 'ischaemic postconditioning']",['combination of all-cause mortality and hospitalisation for heart failure'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",1234.0,0.0824787,There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004).,"[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nepper-Christensen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dan Eik', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hans-Henrik', 'Initials': 'HH', 'LastName': 'Tilsted', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Frants', 'Initials': 'F', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Joshi', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Sørensen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bang', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Catheterisation Lab, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aarøe', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lønborg', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-314952'] 3190,32071176,Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial.,"INTRODUCTION Recent evidence suggests that for certain clinical conditions, placebos can improve clinical outcomes even without deception. These so-called open-label placebos (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles. Although premenstrual syndrome (PMS) seems to be considerably susceptible to placebo effects, no study has examined open-OLP responses on PMS. METHODS AND ANALYSIS To test the efficacy of OLPs in women suffering from PMS, a clinical randomised controlled trial including two OLP study groups (with and without treatment rationale) was designed to investigate on the effect on PMS. PMS symptoms are monitored on a daily basis via a symptom diary, adverse events are monitored intermittently. The study started in spring 2018 and patients will be included until a maximum of 150 participants are randomised. Besides the primary outcome PMS symptom intensity and interference, an array of further variables is assessed. Multilevel modelling will be used for data analyses. ETHICS AND DISSEMINATION Ethics approval was obtained from the Ethics Committee Northwest and Central Switzerland. Results of the main analysis and of secondary analyses will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: (1) ClinicalTrials.gov (NCT03547661); (2) Swiss national registration (SNCTP000002809).",2020,These so-called open-label placebos (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles.,"['spring 2018 and patients will be included until a maximum of 150 participants are randomised', 'women suffering from PMS', 'women with premenstrual syndrome']","['Open-label placebo', 'OLPs']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],2.0,0.446556,These so-called open-label placebos (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles.,"[{'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Frey Nascimento', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland antje.freynascimento@unibas.ch.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kossowsky', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Division of Clinical Psychology and Epidemiology, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Cosima', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2019-032868'] 3191,32054509,"Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial.","BACKGROUND The population of adult patients with early-treated phenylketonuria (PKU) following newborn screening is growing substantially. The ideal target range of blood phenylalanine (Phe) levels in adults outside pregnancy is a matter of debate. Therefore, prospective intervention studies are needed to evaluate the effects of an elevated Phe concentration on cognition and structural, functional, and neurometabolic parameters of the brain. METHODS The PICO (Phenylalanine and Its Impact on Cognition) Study evaluates the effect of a 4-week Phe load on cognition and cerebral parameters in adults with early-treated PKU in a double-blind, randomized, placebo-controlled, crossover, noninferiority trial. PARTICIPANTS Thirty adult patients with early-treated PKU and 30 healthy controls comparable to patients with regard to age, sex, and educational level will be recruited from the University Hospitals Bern and Zurich, Switzerland. Patients are eligible for the study if they are 18 years of age or older and had PKU diagnosed after a positive newborn screening and were treated with a Phe-restricted diet starting within the first 30 days of life. INTERVENTION The cross-over intervention consists of 4-week oral Phe or placebo administration in patients with PKU. The study design mimics a Phe-restricted and a Phe-unrestricted diet using a double-blinded, placebo-controlled approach. OBJECTIVES The primary objective of the PICO Study is to prospectively assess whether a temporarily elevated Phe level influences cognitive performance (working memory assessed with a n-back task) in adults with early-treated PKU. As a secondary objective, the PICO Study will elucidate the cerebral (fMRI, neural activation during a n-back task; rsfMRI, functional connectivity at rest; DTI, white matter integrity; and ASL, cerebral blood flow) and neurometabolic mechanisms (cerebral Phe level) that accompany changes in Phe concentration. Cognition, and structural and functional parameters of the brain of adult patients with early-treated PKU will be cross-sectionally compared to healthy controls. All assessments will take place at the University Hospital Bern, Switzerland. RANDOMIZATION Central randomization will be used to assign participants to the different treatment arms with age, sex, and center serving as the stratification factors. Randomization lists will be generated by an independent statistician. Blinding: All trial personnel other than the statistician generating the randomization list and the personnel at the facility preparing the interventional product are blinded to the assigned treatment. DISCUSSION Using a combination of neuropsychological and neuroimaging data, the PICO Study will considerably contribute to improve the currently insufficient level of evidence on how adult patients with early-treated PKU should be managed. TRIAL REGISTRATION The study is registered at clinicaltrials.gov (NCT03788343) on the 27th of December 2018, at kofam.ch (SNCTP000003117) on the 17th of December 2018, and on the International Clinical Trials Registry Platform of the WHO.",2020,"PARTICIPANTS Thirty adult patients with early-treated PKU and 30 healthy controls comparable to patients with regard to age, sex, and educational level will be recruited from the University Hospitals Bern and Zurich, Switzerland.","['27th of December\xa02018, at kofam.ch (SNCTP000003117)\xa0on the 17th of December 2018, and on the International Clinical Trials Registry Platform of the WHO', 'adult patients with phenylketonuria (the PICO study', 'adults with early-treated PKU', 'patients with PKU', 'adult patients with early-treated PKU', 'Thirty adult patients with early-treated PKU and 30 healthy controls comparable to patients with regard to age, sex, and educational level will be recruited from the University Hospitals Bern and Zurich, Switzerland', 'Patients are eligible for the study if they are 18\u2009years of age or older and had PKU diagnosed after a positive newborn screening and were treated with a Phe-restricted diet starting within the first 30\u2009days of life', 'adults outside pregnancy', 'adult patients with early-treated phenylketonuria (PKU) following newborn screening']","['phenylalanine', 'PICO (Phenylalanine and Its Impact on Cognition', 'placebo-controlled approach', 'placebo']","['cognitive, cerebral, and neurometabolic parameters', 'cognition and cerebral parameters', 'cerebral (fMRI, neural activation during a n-back task; rsfMRI, functional connectivity at rest; DTI, white matter integrity; and ASL, cerebral blood flow) and neurometabolic mechanisms (cerebral Phe level']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0027617', 'cui_str': 'Newborn Screening'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0047143', 'cui_str': 'tmdPHE'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.225012,"PARTICIPANTS Thirty adult patients with early-treated PKU and 30 healthy controls comparable to patients with regard to age, sex, and educational level will be recruited from the University Hospitals Bern and Zurich, Switzerland.","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Trepp', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Raphaela', 'Initials': 'R', 'LastName': 'Muri', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Abgottspon', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Bosanska', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hochuli', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Slotboom', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rummel', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kreis', 'Affiliation': 'Magnetic Resonance Methodology Unit, Department of Biomedical Research & Institute of Interventional, Diagnostic and Pediatric Radiology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Regula', 'Initials': 'R', 'LastName': 'Everts', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland. regula.everts@insel.ch.'}]",Trials,['10.1186/s13063-019-4022-z'] 3192,31794512,"Influence of St. John's Wort on Intravenous Fentanyl Pharmacokinetics, Pharmacodynamics, and Clinical Effects: A Randomized Clinical Trial.","BACKGROUND Patients often use complementary and alternative herbal medicines, hence, potential exists for adverse herb-drug interactions. Fentanyl is metabolized by hepatic CYP3A4 and considered transported by blood-brain barrier P-glycoprotein. Both disposition processes could be upregulated by the herbal St. John's wort. This investigation evaluated effects of St. John's wort on fixed-dose and apparent steady-state IV fentanyl pharmacokinetics, pharmacodynamics, and clinical effects. METHODS Healthy volunteers received a fentanyl fixed-dose infusion and an individually tailored target controlled infusion on separate days, before and after 30-day St. John's wort (300 mg thrice daily; n = 8) or placebo control (n = 8) in a randomized parallel-group design. Fentanyl plasma concentrations, pupil diameter, analgesic response to experimental pain (cold pressor), subjective side effects, and cognitive effects were measured. Plasma fentanyl concentrations and changes in pupil diameter were subjected to pharmacokinetic-pharmacodynamic modeling. RESULTS St. John's wort did not alter fentanyl pharmacokinetics. Clearance (l/min) before and after St. John's wort (1.13 ± 0.29 and 1.24 ± 0.26, respectively) or placebo (0.96 ± 0.28 and 1.12 ± 0.27, respectively) were not different. St. John's wort also did not affect fentanyl pharmacodynamics as measured by pupil constriction after fixed-dose and tailored fentanyl infusions. EC50 (ng/ml) was 1.1 ± 0.7 and 1.4 ± 0.9 before and after St. John's wort versus 1.2 ± 0.8 and 1.4 ± 1.7 before and after placebo. Effect site equilibration time, T½,ke0 (min), was 12.8 ± 5.3 and 11.3 ± 6.4 before and after St. John's wort versus 11.4 ± 6.4 and 11.1 ± 5.6 before and after placebo. St. John's wort had no influence on analgesia, cognitive performance, or somatic cognitive-affective effects of fentanyl. CONCLUSIONS St. John's wort did not alter fentanyl pharmacokinetics, pharmacodynamics or clinical effects, suggesting no effect on hepatic clearance or blood-brain barrier efflux. Patients taking St. John's wort will likely not respond differently to IV fentanyl for anesthesia or analgesia.",2020,"St. John's wort had no influence on analgesia, cognitive performance, or somatic cognitive-affective effects of fentanyl. ",['Healthy volunteers'],"['Fentanyl', 'placebo', 'fentanyl fixed-dose infusion and an individually tailored target controlled infusion', 'placebo control']","['clinical behavior of fentanyl', 'fentanyl pharmacokinetics', 'Fentanyl plasma concentrations, pupil diameter, analgesic response to experimental pain (cold pressor), subjective side effects, and cognitive effects', 'analgesia, cognitive performance, or somatic cognitive-affective effects', 'Clearance', 'Plasma fentanyl concentrations and changes in pupil diameter', 'hepatic clearance or blood-brain barrier efflux', 'fentanyl pharmacokinetics, pharmacodynamics or clinical effects']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005854', 'cui_str': 'Hemato-Encephalic Barrier'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.080582,"St. John's wort had no influence on analgesia, cognitive performance, or somatic cognitive-affective effects of fentanyl. ","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Loughren', 'Affiliation': 'From the Department of Anesthesia and Operative Services, Madigan Army Medical Center, Tacoma, Washington (M.J.L.) the Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina (E.D.K) the Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (M.J.L., D.D.S.) the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington (M.C.K.-R., K.S., D.D.S.).'}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Kharasch', 'Affiliation': ''}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Kelton-Rehkopf', 'Affiliation': ''}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': ''}, {'ForeName': 'Danny D', 'Initials': 'DD', 'LastName': 'Shen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003065'] 3193,31364896,"Augmented Biofeedback Training with Physical Therapy Improves Visual-Motor Integration, Visual Perception, and Motor Coordination in Children with Spastic Hemiplegic Cerebral Palsy: A Randomised Control Trial.","Aim: The aim of this study is to investigate the efficacy of combining augmented biofeedback training and standard therapy for improving visual-motor integration (VMI), visual perception (VP), and motor coordination (MC) in children with spastic cerebral palsy (CP). Methods: Participants were 45 children, 5-8 years of age, with spastic hemiplegic CP. They were randomized into three groups: group A followed a 3-month specially designed program physical therapy intervention to facilitate VMI and VP. Group B received augmented biofeedback training. Group C received augmented biofeedback training and the physical therapy program provided to group A. The treatment sessions lasted 60 min, three times a week for three months. The Beery-Buktenica Developmental Test of VMI and its supplemental tests were used to evaluate the children before and after the program. Results: After a 3-month treatment, standard scores and age equivalent scores for VMI, VP, and MC were significantly higher in group C compared with group A. Conclusion: The combination of augmented biofeedback and physical therapy could be used to improve VMI, VP, and MC in children with spastic hemiplegic CP.",2020,"After a 3-month treatment, standard scores and age equivalent scores for VMI, VP, and MC were significantly higher in group C compared with group A. CONCLUSION ","['children with spastic hemiplegic CP', 'Participants were 45 children, 5-8\u2009years of age, with spastic hemiplegic CP', 'Children with Spastic Hemiplegic Cerebral Palsy', 'children with spastic cerebral palsy (CP']","['augmented biofeedback training', 'augmented biofeedback and physical therapy', 'program physical therapy intervention to facilitate VMI and VP', 'augmented biofeedback training and the physical therapy program provided to group A', 'biofeedback training and standard therapy', 'Biofeedback Training with Physical Therapy']","['VMI, VP, and MC', 'standard scores and age equivalent scores for VMI, VP, and MC', 'visual-motor integration (VMI), visual perception (VP), and motor coordination (MC', 'Visual-Motor Integration, Visual Perception, and Motor Coordination']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042830', 'cui_str': 'Visual Perception'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]",45.0,0.0126622,"After a 3-month treatment, standard scores and age equivalent scores for VMI, VP, and MC were significantly higher in group C compared with group A. CONCLUSION ","[{'ForeName': 'Reem M', 'Initials': 'RM', 'LastName': 'Alwhaibi', 'Affiliation': 'Rehabilitation Sciences Department, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Reham S', 'Initials': 'RS', 'LastName': 'Alsakhawi', 'Affiliation': 'Rehabilitation Sciences Department, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Safaa M', 'Initials': 'SM', 'LastName': 'ElKholi', 'Affiliation': 'Rehabilitation Sciences Department, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2019.1646375'] 3194,31274786,Creation of nurse-specific integrated interprofessional collaboration and team-efficiency scenario/video improves trainees' attitudes and performances.,"BACKGROUND It is importance to train the interprofessional collaboration (IPC) and team-efficiency (TE) of medical trainees. This prospective study evaluates whether implementation of scenario/video-created workshops in integrated IPC and TE (IIT) program provides additional benefits for IPC-TE skills of nursing trainees. METHODS Mock simulation with two IIT scenarios was held as preintervention IPC-TE assessment. Basic and advanced workshops were arranged for teams of intervention groups for creation of discipline-specific scenario and video. Thirty-six nursing trainees were randomized into teams of five members (three nursing students, one standardized medical student, and one standardized trainees of other profession) in either intervention (scenario plus video and scenario) or control groups. After intervention, all groups received the formal simulation-based assessment using another two IIT scenario. In addition to instructors-based assessment of team' performance in mock and formal IIT simulation using interprofessional team collaboration scale (AITCS), self-assessment of attitudes and program-value score were completed by each trainee, using attitudes toward interprofessional health care teams scale (ATIHCTS) at all stages. RESULTS Nursing trainees in intervention group gave high satisfaction score to this IIT intervention. In comparison with control group, greater increase in instructor-assessed team performance in the ""partnership,"" ""cooperation,"" and ""shared decision making"" domains of AITCS and the self-assessed ""quality of care delivery"" and TE domains of ATIHCTS were noted in the intervention groups. The overall improvement was greater in the scenario plus video group than those in the scenario group. Further, these improvements among nursing trainees persisted until follow-up stage at 4-weeks later. CONCLUSION For nursing trainees, our study suggested that implementation of a scenario creation-based training resulted in additional improvement in trainee' IPC and TE behaviors and attitudes. Additionally, making video of newly created nurse-specific scenario enhances partnership and cooperation among nursing trainees and their interprofessional team members.",2019,"In comparison with control group, greater increase in instructor-assessed team performance in the ""partnership,"" ""cooperation,"" and ""shared decision making"" domains of AITCS and the self-assessed ""quality of care delivery"" and TE domains of ATIHCTS were noted in the intervention groups.","['Thirty-six nursing trainees were randomized into teams of five members (three nursing students, one standardized medical student, and one standardized trainees of other profession) in either', 'nursing trainees']","['formal simulation-based assessment using another two IIT scenario', 'scenario/video-created workshops in integrated IPC and TE (IIT) program', 'intervention (scenario plus video and scenario) or control groups']","['instructor-assessed team performance', 'overall improvement', 'interprofessional team collaboration scale (AITCS), self-assessment of attitudes and program-value score', ""trainee' IPC and TE behaviors and attitudes""]","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0556993', 'cui_str': 'Instructor (occupation)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0222045'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",36.0,0.024097,"In comparison with control group, greater increase in instructor-assessed team performance in the ""partnership,"" ""cooperation,"" and ""shared decision making"" domains of AITCS and the self-assessed ""quality of care delivery"" and TE domains of ATIHCTS were noted in the intervention groups.","[{'ForeName': 'Tsu-Hui', 'Initials': 'TH', 'LastName': 'Shiao', 'Affiliation': 'Division of Clinical Skills Training, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chen-Yi', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Yang', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shinn-Jang', 'Initials': 'SJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chia-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Jen-Feng', 'Initials': 'JF', 'LastName': 'Liang', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shou-Yen', 'Initials': 'SY', 'LastName': 'Kao', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000116'] 3195,31362183,Oxytocin modulates alcohol-cue induced functional connectivity in the nucleus accumbens of social drinkers.,"The brain oxytocin system is involved in a wide range of addictive behaviors, inhibiting prime- and cue-induced relapse in preclinical models of substance use disorders. Especially the ability of oxytocin to modulate connectivity between the nucleus accumbens (NAc) and cortical regions has been identified as a factor likely to be critical to its effects on relapse. We thus investigated the effect of oxytocin on NAc functional connectivity during an alcohol cue-reactivity task. Thirteen male social drinkers participated in a randomized double-blind placebo-controlled cross-over functional magnetic resonance imaging (fMRI) alcohol cue-reactivity task with and without prior intranasal application of 24 IU oxytocin. Effects of oxytocin and functional connectivity during presentation of alcohol cues were assessed using ROI-to-ROI generalized psychophysiological interaction analyses. Oxytocin application significantly reduced NAc connectivity with the cuneus and thalamo-occipital connectivity, while enhancing connectivity between the paracingulate gyrus and precentral gyrus. This effect was specific to the alcohol presentation and was not found during processing of neutral pictures. In addition, the NAc-cuneus connectivity significantly correlated with alcohol cue-induced craving during the scanning session. For the first time, we could show that oxytocin selectively attenuates NAc connectivity during an alcohol cue-reactivity task which was related to changes in subjective craving for alcohol. This might reflect an attenuation of alcohol-cue saliency by oxytocin, which improves inhibitory control over craving and cue reactivity.",2019,"In addition, the NAc-cuneus connectivity significantly correlated with alcohol cue-induced craving during the scanning session.","['Thirteen male social drinkers', 'social drinkers']","['placebo-controlled cross-over functional magnetic resonance imaging (fMRI) alcohol cue-reactivity task with and without prior intranasal application of 24 IU oxytocin', 'Oxytocin', 'oxytocin']","['NAc connectivity', 'NAc functional connectivity']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",13.0,0.0501919,"In addition, the NAc-cuneus connectivity significantly correlated with alcohol cue-induced craving during the scanning session.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), Heidelberg University, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Reinhard', 'Affiliation': 'Department of Biostatistics, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Bühler', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), Heidelberg University, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Vollstädt-Klein', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), Heidelberg University, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Kiefer', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), Heidelberg University, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Koopmann', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), Heidelberg University, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104385'] 3196,31929107,Correction: Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol for a Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/11002.].,2020,[This corrects the article DOI: 10.2196/11002.].,['Patients With Type 2 Diabetes (the DELISH Study'],"['Mindful Eating Training', 'Carbohydrate-Restricted Diet']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",[],,0.0197054,[This corrects the article DOI: 10.2196/11002.].,"[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saslow', 'Affiliation': 'School of Nursing, Department of Health Behavior and Biological Sciences, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Moran', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, San Francisco General Hospital, San Francisco, CA, United States.'}, {'ForeName': 'Priyanka K', 'Initials': 'PK', 'LastName': 'Wali', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Abousleiman', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hartman', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Richler', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schleicher', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hartogensis', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Hecht', 'Affiliation': 'UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}]",JMIR research protocols,['10.2196/17226'] 3197,31961463,Metformin plus megestrol acetate compared with megestrol acetate alone as fertility-sparing treatment in patients with atypical endometrial hyperplasia and well-differentiated endometrial cancer: a randomised controlled trial.,"OBJECTIVE To assess the efficacy of metformin in megestrol acetate (MA)-based fertility-sparing treatment for patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC). DESIGN A randomised, single-centre, open-label, controlled trial conducted between October 2013 and December 2017. SETTING Shanghai OBGYN Hospital of Fudan University, China. POPULATION A total of 150 patients (18-45 years old) with primary AEH or well-differentiated EEC were randomised into an MA group (n = 74) and an MA plus metformin group (n = 76). METHODS Patients with AEH or EEC were firstly stratified, then randomised to receive MA (160 mg orally, daily) or MA (160 mg orally, daily) plus metformin (500 mg orally, three times a day). MAIN OUTCOMES AND MEASURES The primary efficacy parameter was the cumulate complete response (CR) rate within 16 weeks of treatment (16w-CR rate); the secondary efficacy parameters were 30w-CR rate and adverse events. RESULTS The 16w-CR rate was higher in the metformin plus MA group than in the MA-only group (34.3 versus 20.7%, odds ratio [OR] 2.0, 95% confidence interval [CI] 0.89-4.51, P = 0.09) but the difference was more significant in 102 AEH patients (39.6 versus 20.4%, OR 2.56, 95% CI 1.06-6.21, P = 0.04). This effect of metformin was also significant in non-obese (51.4 versus 24.3%, OR 3.28, 95% CI 1.22-8.84, P = 0.02) and insulin-sensitive (54.8 versus 28.6%, OR 3.04, 95% CI 1.03-8.97, P = 0.04) subgroups of AEH women. No significant result was found in secondary endpoints. CONCLUSION As a fertility-sparing treatment, metformin plus MA was associated with a higher early CR rate compared with MA alone in AEH patients. TWEETABLE ABSTRACT For AEH patients, metformin plus MA might be a better fertility-sparing treatment to achieve a higher early CR rate compared with MA alone.",2020,"No significant result was found in secondary endpoints. ","['group (n=76', 'Totally 150 patients (18-45 years old) with primary AEH or well-differentiated EEC', 'patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC', 'Patients with AEH or EEC', 'patients with atypical endometrial hyperplasia and well differentiated endometrial cancer', 'Shanghai OBGYN hospital of Fudan university, China', 'October 2013 and December 2017']","['Metformin plus Megestrol Acetate (MA', 'metformin', 'MA plus metformin', 'metformin plus MA', 'MA alone', 'megestrol acetate (MA)-based fertility-sparing treatment', 'MA']","['CR rate and adverse events', 'cumulate complete response (CR) rates', 'early CR rate', 'CR rate', 'insulin-sensitive']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0600216', 'cui_str': 'Common Market'}, {'cui': 'C0349579', 'cui_str': 'Atypical Endometrial Hyperplasia'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065879', 'cui_str': 'Megestrol Acetate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]",150.0,0.149445,"No significant result was found in secondary endpoints. ","[{'ForeName': 'B-Y', 'Initials': 'BY', 'LastName': 'Yang', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gulinazi', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Epidemiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Ning', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Cheng', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'W-W', 'Initials': 'WW', 'LastName': 'Shan', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'X-Z', 'Initials': 'XZ', 'LastName': 'Luo', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'H-W', 'Initials': 'HW', 'LastName': 'Zhang', 'Affiliation': 'Department of Cervical Diseases, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'F-H', 'Initials': 'FH', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Sonography, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Shanghai JiAi Genetics and IVF Institute, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'X-J', 'Initials': 'XJ', 'LastName': 'Chen', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16108'] 3198,31362530,Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial.,"BACKGROUND Metformin is first-line therapy for type 2 diabetes mellitus, although its effects on the cardiovascular system are unproved. METHODS In this post hoc analysis, patients in SAVOR-TIMI 53 (Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus) with baseline biomarker samples (n=12 156) were classified as ever versus never taking metformin during the trial period. Associations between metformin exposure and outcomes were estimated with inverse probability of treatment weighting Cox modeling for the composite end point of cardiovascular death, myocardial infarction, or ischemic stroke, as well as cardiovascular death and all-cause mortality, with biomarkers included as covariates. Additional sensitivity analyses included propensity score matching and Cox multivariable models. RESULTS Of the 12 156 patients with baseline biomarker samples, 8971 (74%) had metformin exposure, 1611 (13%) had prior heart failure, and 1332 (11%) had at least moderate chronic kidney disease (estimated glomerular filtration rate ≤45 mL·min -1 ·1.73 m -2 ). Metformin use was associated with no difference in risk for the composite end point (hazard ratio for inverse probability of treatment weighting, 0.92 [95% CI, 0.76-1.11]) but lower risk of all-cause mortality (hazard ratio for inverse probability of treatment weighting, 0.75 [95% CI, 0.59-0.95]). There was no significant relationship between metformin use and these end points in patients with prior heart failure or moderate to severe chronic kidney disease. CONCLUSIONS In a cohort of 12 156 patients with type 2 diabetes mellitus and high cardiovascular risk, metformin use was associated with lower rates of all-cause mortality, including after adjustment for clinical variables and biomarkers, but not lower rates of the composite end point of cardiovascular death, myocardial infarction, or ischemic stroke. This association was most apparent in patients without prior heart failure or moderate to severe chronic kidney disease. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01107886.",2019,"Metformin use was associated with no difference in risk for the composite end point (HRIPTW 0.92; 95% CI 0.76-1.11), but lower risk of all-cause mortality (HR IPTW 0.75; 95% CI 0.59-0.95).","['12,156 patients with baseline biomarker samples, 8,971 (74%) had metformin exposure, 1,611 (13%) had prior HF, and 1,332 (11', 'patients without prior HF or moderate to severe CKD', 'Patients with Diabetes with or without Heart Failure or Kidney Dysfunction', 'type 2 diabetes mellitus (T2DM', 'patients in SAVOR-TIMI 53 with baseline biomarker samples (n=12,156) were classified as Ever versus Never taking', '12,156 patients with T2DM and high CV risk']","['Metformin', 'metformin']","['CV death, myocardial infarction (MI), or ischemic stroke as well as CV death', 'CV death, MI, or ischemic stroke', 'inverse probability of treatment weighting (IPTW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.085248,"Metformin use was associated with no difference in risk for the composite end point (HRIPTW 0.92; 95% CI 0.76-1.11), but lower risk of all-cause mortality (HR IPTW 0.75; 95% CI 0.59-0.95).","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Clinical Trials), Département Hospitalo-Universitaire FIRE (Fibrosis, Inflammation, Remodelling), Université de Paris, Sorbonne Paris-Cité, France (P.G.S.).'}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kanevsky', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.040144'] 3199,32068688,"Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial.","OBJECTIVES To evaluate the safety, pharmacokinetics, and preliminary efficacy of NT-814, a dual neurokinin 1,3 antagonist, in postmenopausal women with vasomotor symptoms (hot flashes). METHODS We completed a double-blind, randomized, placebo-controlled trial in three US clinical research units in 76 postmenopausal women with moderate/severe hot flashes. Participants were randomized to 14 days of once-daily NT-814 or placebo within each of four sequential dose cohorts; 50, 100, 150, and 300 mg. Participants completed diaries of hot flash frequency and severity and waking due to night sweats before (baseline) and during treatment. RESULTS All prespecified efficacy parameters (24-h hot flash frequency and severity, frequency of waking due to night sweats) decreased in all groups (including placebo). Mean reduction from baseline at week 2 in moderate/severe hot flash frequency was 37% in the placebo group and, respectively, 24% (P = 0.048 vs placebo), 59% (P = 0.155), 84% (P < 0.001) and 66% (P = 0.022) in the 50 mg, 100 mg, 150 mg, and 300 mg NT-814 groups; in waking due to night sweats reduction was 20% (P = 0.059), 55% (P = 0.135), 81% (P < 0.001), and 63% (P = 0.031) in the NT-814 groups and 32% in the placebo group. The improvement with NT-814 ≥150 mg was also evident in the first week of treatment. The most common treatment-related adverse events were mild somnolence and headache, more frequently in the 300 mg group. Safety monitoring identified no concerns. CONCLUSIONS Once-daily NT-814 (≥150 mg/d) resulted in a rapid, marked improvement in hot flashes and waking due to night sweats. No safety concerns were identified. Doses up to 300 mg were well tolerated.",2020,"The most common treatment-related adverse events were mild somnolence and headache, more frequently in the 300 mg group.","['postmenopausal women', '76 postmenopausal women with moderate/severe hot flashes', 'postmenopausal women with vasomotor symptoms (hot flashes']","['placebo', 'NT-814, a dual neurokinin 1 and 3 receptor antagonist', 'NT-814 or placebo', 'NT-814']","['tolerated', 'vasomotor symptoms', 'efficacy parameters (24-h hot flash frequency and severity, frequency of waking due to night sweats', 'diaries of hot flash frequency and severity and waking due to night sweats', 'mild somnolence and headache', 'hot flashes and waking due to night sweats', 'severe hot flash frequency', 'Mean reduction']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0028081', 'cui_str': 'Night sweats (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",76.0,0.462035,"The most common treatment-related adverse events were mild somnolence and headache, more frequently in the 300 mg group.","[{'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Trower', 'Affiliation': 'NeRRe Therapeutics Limited, Stevenage, UK.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ballantyne', 'Affiliation': 'NeRRe Therapeutics Limited, Stevenage, UK.'}, {'ForeName': 'Hadine', 'Initials': 'H', 'LastName': 'Joffe', 'Affiliation': ""Connors Center for Women's Health and Gender Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kerr', 'Affiliation': 'NeRRe Therapeutics Limited, Stevenage, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Pawsey', 'Affiliation': 'NeRRe Therapeutics Limited, Stevenage, UK.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001500'] 3200,31314598,Visual Performance and High-Order Aberrations with Different Contact Lens Prototypes with Potential for Myopia Control.,"Purpose : Contact lenses (CLs) used for myopia control incorporate variable power distribution across the optic zone potentially creating degradation of the high-order aberrations. The present study aims to evaluate the retinal image quality and visual performance in three prototypes of CLs intended to control axial elongation of the eye before they are considered for clinical trials. Methods : This is a non-dispensing cross-over, double-blind study where 30 right eyes of myopic subjects worn 3 multifocal test lenses and 1 monofocal control lens in random order. Lens 1 was a radial refractive gradient design (center distance) and Lens 2 and 3 center-near with an additional annular ring for near. Nominal add power was 2.00D, 1.50D, and 2.00D, respectively. Subjects had an age 21.96 ± 2.23 years [18-30] and mean spherical equivalent refraction M = -2.23 ± 1.50D [-0.75 to -5.50] with refractive astigmatism below -0.75D. Higher-order aberrations (HOA), glare formation (halo), high- and low-contrast LogMAR visual acuity (VA), and contrast sensitivity function (CSF) was measured under monocular conditions. Results : All individual terms of HOA and total root mean square from 3rd to 8th order increased significantly with the 3 test lenses compared to control. Between test lenses, Lens 1 increased significantly the higher HOA compared with Lens 2 and Lens 3. Halo size was significantly larger with test lenses compared with control, with Lens 1 showing the largest. VA under high-contrast conditions was similar for all lenses. Under low-contrast conditions, Lens 1 and Lens 2 performed significantly worse than control (Bonferroni post hoc correction, p < 0.001). CSF was below normal limits with Lens 1 for 3 and 6 cpd spatial frequency but was not significantly different between test lenses and control. Conclusions : Lenses with larger stabilized areas for distance vision interfere less with VA and induce lower values of HOA and image degradation.",2020,CSF was below normal limits with Lens 1 for 3 and 6 cpd spatial frequency but was not significantly different between test lenses and control. ,"['Subjects had an age 21.96 ± 2.23 years [18-30] and mean spherical equivalent refraction M = -2.23 ± 1.50D ', '30 right eyes of myopic subjects worn 3 multifocal test lenses and 1 monofocal control lens in random order']",['Contact lenses (CLs'],"['CSF', 'Visual Performance and High-Order Aberrations', 'higher HOA', 'Halo size', 'HOA and image degradation', 'HOA and total root', 'retinal image quality and visual performance', 'refractive astigmatism below -0.75D. Higher-order aberrations (HOA), glare formation (halo), high- and low-contrast LogMAR visual acuity (VA), and contrast sensitivity function (CSF', 'mean square']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0229089', 'cui_str': 'RE - Right eye'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0009836', 'cui_str': 'Contact Lenses'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0649652', 'cui_str': 'Benzenamine, 4-(hexyloxy)-'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C3887688', 'cui_str': 'Glare (finding)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}]",30.0,0.0546848,CSF was below normal limits with Lens 1 for 3 and 6 cpd spatial frequency but was not significantly different between test lenses and control. ,"[{'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Martins', 'Affiliation': 'Department of Physics (Optometry), Clinical & Experimental Optometry Research Lab (CEORLab), Center of Physics, University of Minho, Braga, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Amorim-De-Sousa', 'Affiliation': 'Department of Physics (Optometry), Clinical & Experimental Optometry Research Lab (CEORLab), Center of Physics, University of Minho, Braga, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Faria-Ribeiro', 'Affiliation': 'Department of Physics (Optometry), Clinical & Experimental Optometry Research Lab (CEORLab), Center of Physics, University of Minho, Braga, Portugal.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Pauné', 'Affiliation': 'Teknon, Barcelona, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'González-Méijome', 'Affiliation': 'Department of Physics (Optometry), Clinical & Experimental Optometry Research Lab (CEORLab), Center of Physics, University of Minho, Braga, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Queirós', 'Affiliation': 'Department of Physics (Optometry), Clinical & Experimental Optometry Research Lab (CEORLab), Center of Physics, University of Minho, Braga, Portugal.'}]",Current eye research,['10.1080/02713683.2019.1645182'] 3201,31958285,"The impact of upper limb exercise on function, daily activities and quality of life in systemic lupus erythematosus: a pilot randomised controlled trial.","OBJECTIVE To assess the effect of upper limb exercise on hand function, daily activities performance and quality of life of patients with systemic lupus erythematosus (SLE). METHODS We performed a pilot randomised, 24-week follow-up, unmasked controlled trial. Inclusion criteria were upper limb arthralgias, a Disabilities of Arm, Shoulder and Hand (DASH) questionnaire score >10 and a stable treatment over the past 3 months. Patients were randomly allocated in the routine care (control) or exercise group that received an individually tailored 30-min daily upper-limb exercise programme by a hand therapist for 12 weeks. We evaluated at 0, 6, 12 and 24 weeks the performance of daily activities for both groups with DASH questionnaire and Health Assessment Questionnaire (HAQ), the grip and pinch strength with Jamar dynamometer and pinch gauge tool, respectively, the dexterity with Purdue pegboard test, the quality of life with Lupus Quality of Life (LupusQoL) Questionnaire and the pain level by Visual Analogue Scale (VAS) score. RESULTS From 293 consecutive SLE patients, data from 32 patients allocated to the exercise group and 30 to the control group were analysed. There was a significant difference between the two groups in percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores from baseline to 6, 12 and 24 weeks, and from baseline to 12 weeks for dexterity test (p<0.001). No interaction was observed between exercise and disease activity or medication use at baseline and during the observation period. CONCLUSION Upper-limb exercise significantly improves hand function, pain, daily activity performance and quality of life in SLE. TRIAL REGISTRATION NUMBER NCT03802578.",2020,"There was a significant difference between the two groups in percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores from baseline to 6, 12 and 24 weeks, and from baseline to 12 weeks for dexterity test (p<0.001).","['293 consecutive SLE patients, data from 32 patients allocated to the exercise group and 30 to the control group were analysed', 'systemic lupus erythematosus', 'patients with systemic lupus erythematosus (SLE']","['upper limb exercise', 'routine care (control) or exercise group that received an individually tailored 30-min daily upper-limb exercise programme by a hand therapist for 12 weeks', 'Upper-limb exercise']","['function, daily activities and quality of life', 'hand function, pain, daily activity performance and quality of life', 'upper limb arthralgias, a Disabilities of Arm, Shoulder and Hand (DASH) questionnaire score', 'DASH questionnaire and Health Assessment Questionnaire (HAQ), the grip and pinch strength with Jamar dynamometer and pinch gauge tool, respectively, the dexterity with Purdue pegboard test, the quality of life with Lupus Quality of Life (LupusQoL) Questionnaire and the pain level by Visual Analogue Scale (VAS) score', 'hand function, daily activities performance and quality of life', 'percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores']","[{'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}]","[{'cui': 'C0454320', 'cui_str': 'Upper limb exercises (regime/therapy)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0418416', 'cui_str': 'Pinched (event)'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0204462', 'cui_str': 'Purdue pegboard test (procedure)'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",293.0,0.100951,"There was a significant difference between the two groups in percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores from baseline to 6, 12 and 24 weeks, and from baseline to 12 weeks for dexterity test (p<0.001).","[{'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Keramiotou', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Joint Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Anagnostou', 'Affiliation': 'Rheumatology Unit, Thriasio General Hospital of Elefsina, Magoula, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Kataxaki', 'Affiliation': 'Rheumatology Unit, Thriasio General Hospital of Elefsina, Magoula, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Galanos', 'Affiliation': 'Laboratory for Research of Musculoskeletal System ""Theodoros Garofalidis"", National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Petros P', 'Initials': 'PP', 'LastName': 'Sfikakis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Joint Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Tektonidou', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Joint Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece mtektonidou@gmail.com.'}]",RMD open,['10.1136/rmdopen-2019-001141'] 3202,32062860,Impact of post-haemorrhoidectomy pain relief checklists on pain outcomes: a randomized controlled trial.,"BACKGROUND Haemorrhoidectomy is associated with significant post-operative pain which is primarily managed pharmacologically. Whether a non-pharmacological adjunct such as a checklist can improve pain outcomes after an open haemorrhoidectomy has yet to be studied. The purpose of this study was to determine if a patient-completed checklist of prescribed post-haemorrhoidectomy pain medications would improve pain management after surgery. METHODS We conducted a dual-centre randomized controlled trial of patients undergoing a Milligan-Morgan haemorrhoidectomy for symptomatic third or fourth degree haemorrhoids. Thirty-five patients were randomized into either a control group which received post-operative pain medication plus a visual analogue scale (VAS) form, or an intervention group which received a post-operative medication checklist in addition to the items the control group received. Both groups recorded their pain levels on the VAS forms at 10.00, 14.00 and 20.00 hours each day for 14 days post-operatively. RESULTS Patients in the checklist group reported a significantly greater reduction in mean VAS pain score of 2.51 (95% confidence interval (CI) 1.34-3.68; P < 0.001) between day 1 post-op and day 14 post-op compared to 1.86 (95% CI 0.77-2.95; P = 0.001) for the control group. There was no significant difference between mean pain experienced by patients in either group over each of the 14 days individually or overall (P = 0.07). CONCLUSION The pain medication checklist lead to a greater reduction in pain between day 1 and 14 after an open haemorrhoidectomy compared to standard care but did not significantly reduce mean pain across any individual days or overall.",2020,"There was no significant difference between mean pain experienced by patients in either group over each of the 14 days individually or overall (P = 0.07). ","['patients undergoing a', 'for symptomatic third or fourth degree haemorrhoids', 'Thirty-five patients']","['haemorrhoidectomy pain medications', 'post-haemorrhoidectomy pain relief checklists', 'Haemorrhoidectomy', 'Milligan-Morgan haemorrhoidectomy', 'control group which received post-operative pain medication plus a visual analogue scale (VAS) form, or an intervention group which received a post-operative medication checklist', 'haemorrhoidectomy']","['mean VAS pain score', 'pain management', 'mean pain', 'pain levels', 'pain outcomes', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}]","[{'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0582521', 'cui_str': 'Morgan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",35.0,0.166353,"There was no significant difference between mean pain experienced by patients in either group over each of the 14 days individually or overall (P = 0.07). ","[{'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Discipline of Surgery, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew J F X', 'Initials': 'MJFX', 'LastName': 'Rickard', 'Affiliation': 'Discipline of Surgery, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Keshava', 'Affiliation': 'Discipline of Surgery, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael K L', 'Initials': 'MKL', 'LastName': 'Suen', 'Affiliation': 'Discipline of Surgery, School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",ANZ journal of surgery,['10.1111/ans.15732'] 3203,31358336,The del Nido versus cold blood cardioplegia in aortic valve replacement: A randomized trial.,"OBJECTIVES To compare the cardioprotective efficacy of a solution that requires only a single infusion at the start of the ischemic duration versus a solution that requires multiple infusions. METHODS Aortic valve replacement was performed for 150 patients, who were randomized into the del Nido (DN) cardioplegia group or the cold blood (CB) cardioplegia group. The DN cardioplegia was delivered every 90 minutes and the CB cardioplegia was delivered every 20 to 30 minutes, or whenever cardiac activity was observed. The primary endpoints were electrical cardiac activity during crossclamp, ventricular fibrillation during reperfusion, and postoperative troponin and creatine kinase (CK-MB isoenzyme) at 24 and 48 hours. RESULTS Electrical activity during crossclamp occurred in 29 (39.7%) patients in the DN group versus 34 (45.3%) patients in the CB group (adjusted P = 1.0). The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41). Troponin values appeared to be lower in the DN group (median, 223.10; interquartile range, 168.35-364.77 pg/mL vs 285.5; 196.20-419.45 pg/mL at 24 hours and 159.60; 125.42-217.20 pg/mL vs 201.60; 160.62-268.45 pg/mL at 48 hours) and CK-MB (median, 14.94; interquartile range, 12.16-20.39 ng/mL vs 17.43; 13.66-22.43 ng/mL at 24 hours and 6.19; 4.41-7.63 ng/mL vs 7.38; 4.74-10.20 ng/mL at 48 hours), but no significance was found. CONCLUSIONS The del Nido cardioplegia protocol is an acceptable alternative for cold blood cardioplegia in patients undergoing aortic valve replacement.",2020,"The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41).","['patients undergoing aortic valve replacement', 'aortic valve replacement', 'Aortic valve replacement was performed for 150 patients']","['cold blood cardioplegia', 'CB cardioplegia', 'del Nido (DN) cardioplegia group or the cold blood (CB) cardioplegia group']","['number of procedures with ventricular fibrillation', 'Troponin values', 'electrical cardiac activity during crossclamp, ventricular fibrillation during reperfusion, and postoperative troponin and creatine kinase (CK-MB isoenzyme', 'cardioprotective efficacy', 'Electrical activity during crossclamp']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0005768'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity (observable entity)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0022173', 'cui_str': 'Isozymes'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",150.0,0.149311,"The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41).","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Sanetra', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland. Electronic address: krzyssan@poczta.onet.pl.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Gerber', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Domaradzki', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Krzych', 'Affiliation': 'Department of Anesthesiology and Intensive Therapy, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Zembala', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Zabrze, Poland; Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Cisowski', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland; Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Zabrze, Poland; Medical University of Silesia, Katowice, Poland.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.05.083'] 3204,31368661,Increased Dairy Product Intake Alters Serum Metabolite Profiles in Subjects at Risk of Developing Type 2 Diabetes.,"SCOPE Metabolomics is increasingly used to identify biomarkers of diet or chronic diseases, such as type 2 diabetes. Yet, metabolite signatures following dairy intake in hyperinsulinemic subjects have not been identified. The objective is to evaluate the effects of a high dairy diet (HD) for 6 weeks (4 servings or more per day), compared with an adequate dairy diet (AD) (2 servings or less per day), on serum metabolite profiles in hyperinsulinemic adults. METHODS AND RESULTS In this crossover trial, subjects are randomized to HD or AD for 6 weeks. Serum metabolites are assessed using GC/MS. Twenty-six subjects completed the study. Levels of pentadecanoic acid, tyrosine and lathosterol are increased in HD, while 1,5-anhydrosorbitol, myo-inositol, 3-aminoisobutyric acid and beta-sitosterol are decreased (p < 0.05). Sorbitol levels are increased after AD, while hexanoic acid, lauric acid, l-kynurenine, methionine, and benzoic acid levels are reduced (p < 0.05). Histidine, caprylic acid, nonanoic acid, decanoic acid, lauric acid, heptadecanoic acid, and benzoic acid levels are increased in HD compared to AD, while malic acid levels are increased in AD compared with HD (p < 0.05). CONCLUSION Higher dairy products intake modifies metabolite profiles in hyperinsulinemic subjects.",2019,"Results showed that levels of pentadecanoic acid (p = 0.04), tyrosine (p = 0.009) and lathosterol (p = 0.03) were increased in HD, while 1,5-anhydrosorbitol (p = 0.02), myo-inositol (p = 0.04), 3-aminoisobutyric acid (p = 0.002) and beta-sitosterol (p = 0.01) were decreased.","['Subjects at Risk of Developing Type 2 Diabetes', 'hyperinsulinemic subjects', 'Twenty-six subjects completed the study (age: 55\xa0±\xa014 years, BMI: 31\xa0±\xa03\xa0kg/m 2 (mean±SD', 'hyperinsulinemic adults']",['high dairy diet (HD'],"['3-aminoisobutyric acid', 'serum metabolite profiles', 'hexanoic acid, lauric acid, L-kynurenine, methionine and benzoic acid levels', 'myo-inositol', 'Serum metabolites', 'levels of pentadecanoic acid', 'lathosterol', 'beta-sitosterol', 'Histidine, caprylic acid, nonanoic acid, decanoic acid, lauric acid, heptadecanoic acid and benzoic acid levels', 'Sorbitol levels']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0047226', 'cui_str': '3-aminoisobutyric acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0019462', 'cui_str': 'Caproic Acids'}, {'cui': 'C0023139', 'cui_str': 'lauric acid'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0053225', 'cui_str': 'Benzoic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0762868', 'cui_str': 'pentadecanoic acid'}, {'cui': 'C0064673', 'cui_str': 'cholest-7-en-3-ol'}, {'cui': 'C0106127', 'cui_str': 'beta Sitosterol'}, {'cui': 'C0019602', 'cui_str': 'L-histidine'}, {'cui': 'C0054616', 'cui_str': 'caprylic acid'}, {'cui': 'C0070210', 'cui_str': 'nonanoic acid'}, {'cui': 'C0057239', 'cui_str': 'decanoic acid'}, {'cui': 'C0065724', 'cui_str': 'margaric acid'}, {'cui': 'C0037688', 'cui_str': 'Sorbitol'}]",26.0,0.0284468,"Results showed that levels of pentadecanoic acid (p = 0.04), tyrosine (p = 0.009) and lathosterol (p = 0.03) were increased in HD, while 1,5-anhydrosorbitol (p = 0.02), myo-inositol (p = 0.04), 3-aminoisobutyric acid (p = 0.002) and beta-sitosterol (p = 0.01) were decreased.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': ""O'Connor"", 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Greffard', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Leclercq', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Julien', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Stanley John', 'Initials': 'SJ', 'LastName': 'Weisnagel', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Gagnon', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Droit', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Bilodeau', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Rudkowska', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Center, 2705 Laurier Boulevard, G1V 4G2, Québec, Canada.'}]",Molecular nutrition & food research,['10.1002/mnfr.201900126'] 3205,31944250,Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial.,"BACKGROUND Despite the risk of delayed motor development in infants born preterm, knowledge about interventions in the neonatal intensive care unitt (NICU) and the effects of dosing is sparse. OBJECTIVE The objectives of this study were to examine the effectiveness of a parent-administered exercise program in the NICU on motor outcome at 3 months corrected age (CA) and the effect of dosing on motor performance. DESIGN This was a randomized clinical trial. SETTING The study was conducted at 3 university hospitals in Tromsø, Trondheim, and Oslo, Norway. PARTICIPANTS A total of 153 infants with gestational age <32 weeks at birth were randomly assigned to intervention or control groups. INTERVENTION A 3-week parent-administered intervention designed to facilitate movements in preterm infants was performed in the NICU. Parents were asked to administer the intervention 10 minutes twice a day. MEASUREMENTS Test of Infant Motor Performance (TIMP) was used to assess short-term outcome at 3 months CA. RESULTS No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores. The adjusted odds of having a clinical z-score < 0 at 3 months CA was about 6 times higher for infants with less than median intervention time than for infants with a longer intervention time. LIMITATIONS The number of infants born before 28 weeks was small. A spillover effect in favor of the control group was possible. We do not know if the infants received physical therapy after discharge from the hospital. CONCLUSIONS There was no difference in motor performance between the intervention group and the control group at 3 months CA. However, an increased intervention dose was positively associated with improved motor outcome.",2020,"No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores.","['3 university hospitals in Tromsø, Trondheim, and Oslo, Norway', 'A total of 153 infants with gestational age < 32 weeks at birth', 'infants born preterm', 'Neonatal Intensive Care Unit']","['parent-administered exercise program', 'physical therapy', 'Patient-Administered Exercise Program']","['TIMP z-score', 'motor outcome', 'Test of Infant Motor Performance (TIMP', 'motor performance', 'total intervention dose and TIMP z-scores']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",153.0,0.132704,"No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores.","[{'ForeName': 'Gunn Kristin', 'Initials': 'GK', 'LastName': 'Øberg', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, PB 6050 Langnes, Tromsø, 9037 Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway, Tromsø, Norway.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Suzann K', 'Initials': 'SK', 'LastName': 'Campbell', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Tordis', 'Initials': 'T', 'LastName': 'Ustad', 'Affiliation': 'Department of Clinical Services, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Ivar', 'Initials': 'I', 'LastName': 'Heuch', 'Affiliation': 'Department of Mathematics, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjarne K', 'Initials': 'BK', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Centre for Sami Health Research, Department of Community Medicine, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Per Ivar', 'Initials': 'PI', 'LastName': 'Kaaresen', 'Affiliation': 'Pediatric and Adolescent Department, University Hospital North Norway; and Department of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Vibeke Smith', 'Initials': 'VS', 'LastName': 'Aulie', 'Affiliation': 'Section of Physiotherapy, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway.'}]",Physical therapy,['10.1093/ptj/pzaa014'] 3206,32067261,"Brief Cognitive-based Psychosocial Intervention and Case Management for Suicide Attempters Discharged from the Emergency Department in Taipei, Taiwan: A Randomized Controlled Study.","OBJECTIVE We examined the effectiveness of brief cognitive-based psychotherapy plus standard case management in the prevention of further suicide attempts, clinical severity, and treatment adherence in a randomized clinical trial compared with standard case management. METHOD Among five hundred and ninety-seven patients presenting with suicide attempts, 147 participants were included. They were randomized into two groups. After a 6-session intervention over four months, all participants were re-evaluated at the 6th and 12th months. RESULTS At a 6-month assessment, the intervention had approximately halved the odds of following suicide attempts and doubled the odds of outpatient visits in comparison with standard case management, although the differences did not attain statistical significance. At a 12-month assessment, the two groups did not differ significantly in any of the outcome variables. Generalized linear mixed models indicated that intervention did not significantly decrease the subsequent suicide risk and severity of clinical symptoms, but it did increase psychiatric outpatient treatment adherence. The subgroup analysis revealed that the intervention increased the outpatient clinic visits only for repetitive attempters, not for first-time attempters. CONCLUSIONS Further studies are needed to test whether more intensive psychotherapy sessions might be more effective in decreasing the probability of further attempt and the severity of symptoms.",2020,"The subgroup analysis revealed that the intervention increased the outpatient clinic visits only for repetitive attempters, not for first-time attempters. ","['five hundred and ninety-seven patients presenting with suicide attempts, 147 participants were included', 'Suicide Attempters']","['brief cognitive-based psychotherapy plus standard case management', 'Brief Cognitive-based Psychosocial Intervention and Case Management']","['psychiatric outpatient treatment adherence', 'outpatient clinic visits', 'subsequent suicide risk and severity of clinical symptoms']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",597.0,0.0364275,"The subgroup analysis revealed that the intervention increased the outpatient clinic visits only for repetitive attempters, not for first-time attempters. ","[{'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Mackay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-Chin', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Center of Suicide Prevention, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chiu-Ron', 'Initials': 'CR', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'Department of Psychiatry, Mackay Memorial Hospital, Taipei, Taiwan.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12626'] 3207,32051025,A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study.,"BACKGROUND Patients with rheumatoid arthritis spend most of their daily hours in sedentary behavior (sitting), a predisposing factor to poor health-related outcomes and all-cause mortality. Interventions focused on reducing sedentary time could be of novel therapeutic relevance. However, studies addressing this topic remain scarce. We aim to investigate the feasibility and efficacy of a newly developed intervention focused on reducing sedentary time, and potential clinical, physiological, metabolic and molecular effects in rheumatoid arthritis. METHODS The Take a STAND for Health study is a 4-month, parallel-group, randomized controlled trial, in which postmenopausal patients with rheumatoid arthritis will set individually tailored, progressive goals to replace their sedentary time with standing and light-intensity activities. Patients will be recruited from the Clinical Hospital (School of Medicine, University of Sao Paulo) and will be assessed at baseline and after a 4-month follow up. Outcomes will include objectively measured sedentary behavior (primary outcome) and physical activity levels, clinical parameters, anthropometric parameters and body composition; aerobic fitness, muscle function, blood pressure, cardiovascular autonomic function, vascular function and structure, health-related quality of life, and food intake. Blood and muscle samples will be collected for assessing potential mechanisms, through targeted and non-targeted approaches. DISCUSSION Findings will be of scientific and clinical relevance with the potential to inform new prescriptions focused on reducing sedentary behavior, a modifiable risk factor that thus far has been overlooked in patients with rheumatoid arthritis. TRIAL REGISTRATION ClinicalTrials.gov, NCT03186924. Registered on 14 June 2017.",2020,"We aim to investigate the feasibility and efficacy of a newly developed intervention focused on reducing sedentary time, and potential clinical, physiological, metabolic and molecular effects in rheumatoid arthritis. ","['rheumatoid arthritis', 'Patients will be recruited from the Clinical Hospital (School of Medicine, University of Sao Paulo) and will be assessed at baseline and after a 4-month follow up', 'patients with rheumatoid arthritis', 'postmenopausal patients with rheumatoid arthritis']",[],"['sedentary behavior (primary outcome) and physical activity levels, clinical parameters, anthropometric parameters and body composition; aerobic fitness, muscle function, blood pressure, cardiovascular autonomic function, vascular function and structure, health-related quality of life, and food intake', 'sedentary time, and potential clinical, physiological, metabolic and molecular effects', 'feasibility and efficacy']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]",[],"[{'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0835541,"We aim to investigate the feasibility and efficacy of a newly developed intervention focused on reducing sedentary time, and potential clinical, physiological, metabolic and molecular effects in rheumatoid arthritis. ","[{'ForeName': 'Ana Jessica', 'Initials': 'AJ', 'LastName': 'Pinto', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Peçanha', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Meireles', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'Fabiana Braga', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Bonfiglioli', 'Affiliation': 'Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, Av. Dr. Arnaldo, 455, Sao Paulo, SP, 05403-900, Brazil.'}, {'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'de Sá Pinto', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'Fernanda Rodrigues', 'Initials': 'FR', 'LastName': 'Lima', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'Rosa Maria Rodrigues', 'Initials': 'RMR', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de São Paulo, Av. Dr. Arnaldo, 455, Sao Paulo, SP, 05403-900, Brazil.'}, {'ForeName': 'Maria Claudia Costa', 'Initials': 'MCC', 'LastName': 'Irigoyen', 'Affiliation': 'Heart Institute, Faculty of Medicine, University of Sao Paulo, Av. Dr. Enéas Carvalho de Aguiar, 44, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'James Edward', 'Initials': 'JE', 'LastName': 'Turner', 'Affiliation': 'Department for Health, University of Bath, Claverton Down Road, Bath, BA2 7AY, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Road, Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne VIC, Australia - 99 Commercial Road, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne VIC, Australia - 99 Commercial Road, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group; Laboratory of Assessment and Conditioning in Rheumatology; Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3° andar, São Paulo, SP, 01246-903, Brazil. gualano@usp.br.'}]",Trials,['10.1186/s13063-020-4104-y'] 3208,32051002,Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial.,"BACKGROUND Sexual concerns are distressing for breast cancer survivors and interfere with their intimate relationships. This study evaluates the efficacy of a four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE). The IE intervention is grounded in social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy to address survivors' sexual concerns and enhance their and their partners' sexual, relationship, and psychological outcomes. METHODS This trial is designed to evaluate the efficacy of the IE intervention in improving survivors' sexual function, the primary study outcome. Secondary outcomes include survivors' sexual distress, partners' sexual function, and survivors' and partners' relationship intimacy and quality as well as psychological distress (depressive symptoms and anxiety symptoms). Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function. Eligible adult female breast cancer survivors reporting sexual concerns and their intimate partners are recruited from two academic sites in the USA and are randomized to either the IE intervention or to a control condition of equal length offering education and support around breast cancer-related health topics (Living Healthy Together). The target sample size is 120 couples. Self-report outcome measures are administered to participants in both conditions at baseline (T1), post-treatment (T2), 3 months post-treatment (T3), and 6 months post-treatment (T4). DISCUSSION Evidence-based interventions are needed to address sexual concerns for breast cancer survivors and to enhance their and their intimate partners' sexual, relationship, and psychological well-being. This randomized controlled trial will allow us to examine the efficacy of a novel couple-based intervention delivered via telephone for breast cancer survivors experiencing sexual concerns and their intimate partners, in comparison with an attention control. Findings of this study could influence clinical care for women with breast cancer and inform theory guiding cancer-related sexual rehabilitation. TRIAL REGISTRATION ClinicalTrials.gov, NCT03930797. Registered on 24 April 2019.",2020,Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function.,"['120 couples', 'breast cancer survivors experiencing sexual concerns and their intimate partners', 'breast cancer survivors', 'women with breast cancer', 'Eligible adult female breast cancer survivors reporting sexual concerns and their intimate partners']","['four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE', 'social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy', 'novel couple-based intervention delivered via telephone', 'couple-based intervention addressing sexual concerns', 'IE intervention or to a control condition of equal length offering education and support around breast cancer-related health topics (Living Healthy Together', 'IE intervention']","[""survivors' sexual distress, partners' sexual function, and survivors' and partners' relationship intimacy and quality as well as psychological distress (depressive symptoms and anxiety symptoms""]","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0302822', 'cui_str': 'Couples Therapy'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0479534,Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function.,"[{'ForeName': 'Jennifer Barsky', 'Initials': 'JB', 'LastName': 'Reese', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA. Jennifer.Reese@fccc.edu.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Zimmaro', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lepore', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Sorice', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Handorf', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Daly', 'Affiliation': 'Department of Clinical Genetics, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Schover', 'Affiliation': 'Will2Love LLC, 1333 Old Spanish Trail, Suite G, #134, Houston, TX, 77054, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kashy', 'Affiliation': 'Department of Psychology, Michigan State University, 316 Physics Road, Room 262, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Westbrook', 'Affiliation': 'Department of Medicine-Oncology, Duke University Medical Center, DUMC 3459, Durham, NC, 27710, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University Medical Center, DUMC 90399, Durham, NC, 27708, USA.'}]",Trials,['10.1186/s13063-019-3975-2'] 3209,32050044,Efficacy and acceptability of self-monitoring via a smartphone application versus traditional paper records in an intensive outpatient eating disorder treatment setting.,"OBJECTIVE Although self-monitoring is an important part of eating disorder treatment, non-adherence is commonly observed among patients asked to maintain paper food records. This study aims to compare the efficacy and acceptability of electronic self-monitoring via Recovery Record to self-monitoring via traditional paper records, in an intensive outpatient (IOP) eating disorder treatment for adults. METHOD Ninety patients were recruited from an IOP eating disorder clinic and randomly assigned to the experimental or control condition. Those in the control condition received the standard treatment delivered by the IOP programme, including the use of paper records for self-monitoring. Those in the experimental condition received the same treatment but used Recovery Record for self-monitoring. RESULTS The results did not demonstrate statistically significant group differences over time on eating disorder symptomatology, and there were no statistically significant group differences on acceptability or adherence. CONCLUSIONS Our pilot efficacy data do not support superiority of the app over paper records in an IOP setting, so proceeding to a larger efficacy trial is not warranted. Future studies should aim to determine whether the app is efficacious as an adjunct to less intensive treatment or to further explore adherence and acceptability outcomes in studies with larger sample sizes. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02484794.",2020,"The results did not demonstrate statistically significant group differences over time on eating disorder symptomatology, and there were no statistically significant group differences on acceptability or adherence. ","['intensive outpatient (IOP) eating disorder treatment for adults', 'Ninety patients were recruited from an IOP eating disorder clinic', 'intensive outpatient eating disorder treatment setting']","['self-monitoring via a smartphone application', 'electronic self-monitoring via Recovery Record to self-monitoring via traditional paper records']","['acceptability or adherence', 'eating disorder symptomatology']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3839717', 'cui_str': 'Eating disorder clinic'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1562582', 'cui_str': 'PACU record'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]",90.0,0.0616803,"The results did not demonstrate statistically significant group differences over time on eating disorder symptomatology, and there were no statistically significant group differences on acceptability or adherence. ","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Keshen', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Helson', 'Affiliation': 'Eating Disorder Program, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Sarrah', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Eating Disorder Program, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dixon', 'Affiliation': 'Eating Disorder Program, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Tregarthen', 'Affiliation': 'Recovery Record Inc., San Francisco, CA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2727'] 3210,31356533,Relationship Gender Equality and Couples Uptake of Oral HIV Self-Testing Kits Delivered by Pregnant Women in Kenya.,"BACKGROUND Higher gender equality is associated with many HIV preventive behaviors, including HIV testing. HIV self-testing is a relatively new testing technology that could assist with HIV prevention. However, there are no studies examining gender equality and HIV self-testing. We examined the associations between gender equality and couples' uptake of HIV self-testing among heterosexual couples expecting a child in central Kenya. METHODS This analysis used data from a HIV self-testing randomized intervention trial among pregnant women attending antenatal care and their male partners. The primary exposures were gender equality (measured by the male partner's attitudes towards intimate partner violence, and the woman's report on her household decision-making power), and the primary outcome was couples' uptake of HIV self-testing. Generalized linear mixed models framework was used to account for site-level clustering. RESULTS In comparison to male partners reporting high acceptance of IPV, couples with male partners reporting medium acceptance (OR=2.36, 95% CI 0.99-5.63) or low acceptance (OR=2.50, 95% 1.20-5.21) were significantly more likely to use HIV self-testing. Gender equality measured by decision-making power was not associated with couples' uptake of HIV self-testing. CONCLUSIONS This study is the first of its kind to examine the association between gender equality and couples' HIV self-testing. This holds important implications for HIV self-testing as we strive to achieve the UNAIDS goal that 90% of individuals living with HIV should know their status.",2019,"In comparison to male partners reporting high acceptance of IPV, couples with male partners reporting medium acceptance (OR=2.36, 95% CI 0.99-5.63) or low acceptance (OR=2.50, 95% 1.20-5.21) were significantly more likely to use HIV self-testing.","['pregnant women attending antenatal care and their male partners', 'Pregnant Women in Kenya', 'heterosexual couples expecting a child in central Kenya']",[],"[""couples' uptake of HIV self-testing"", ""gender equality (measured by the male partner's attitudes towards intimate partner violence, and the woman's report on her household decision-making power"", 'Relationship Gender Equality and Couples Uptake of Oral HIV Self-Testing Kits']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]",,0.0329972,"In comparison to male partners reporting high acceptance of IPV, couples with male partners reporting medium acceptance (OR=2.36, 95% CI 0.99-5.63) or low acceptance (OR=2.50, 95% 1.20-5.21) were significantly more likely to use HIV self-testing.","[{'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Vrana-Diaz', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite 303, Charleston, SC, USA 29425.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Korte', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite 303, Charleston, SC, USA 29425.'}, {'ForeName': 'Mulugeta', 'Initials': 'M', 'LastName': 'Gebregziabher', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite 303, Charleston, SC, USA 29425.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Richey', 'Affiliation': 'Section of Infectious Disease, Department of Medicine, Louisiana State University Health Sciences Center, 1542 Tulane Avenue, Suite 331, New Orleans, LA 70112.'}, {'ForeName': 'Anbesaw', 'Initials': 'A', 'LastName': 'Selassie', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite 303, Charleston, SC, USA 29425.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sweat', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 176 Croghan Spur Road, Suite 104, Charleston, SC 29407.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gichangi', 'Affiliation': 'Jhpiego, Ring Road, Arlington block, Nairobi, Kenya.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001037'] 3211,31068396,Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study.,"BACKGROUND Improving uptake of colorectal cancer screening has the potential of saving thousands of lives. We compared the effectiveness of automated and live prompts and reminders as part of a mailed fecal immunochemical test (FIT) outreach program. DESIGN AND METHODS Participants were 1767 adults aged 50 to 75 eyars who were not up-to-date with colorectal cancer screening recommendations at a participating community health center clinic. In addition to a mailed FIT kit, participants were randomized to receive (1) a text message prompt and 2 automated phone call reminders (automated condition); (2) up to 3 live call reminders (live condition); or (3) a text message prompt, 2 automated call reminders, and up to 3 live reminders (combined automated plus live condition). We assessed FIT completion rates in each group 6 months following randomization. KEY RESULTS Nearly one-third of participants completed an FIT within 6 months. Compared with adults allocated to the automated condition, FIT completion rates were higher in adults allocated to the live condition (32.3% vs 26.0%; adjusted difference, 6.3 percentage points; 95% CI, 1.1-11.4) and in adults allocated to the combined automated plus live condition (35.7% vs 26.0%; adjusted difference, 9.7 percentage points; 95% CI, 4.4-14.9). The number of kits needed to mail to achieve a completed FIT ranged from 2.8 in the combined automated plus live condition to 3.8 in the automated condition. CONCLUSIONS Among unscreened individuals in this population, live phone call reminders either alone or in combination with automated prompts and reminders outperformed automated approaches alone.",2019,"Among unscreened individuals in this population, live phone call reminders either alone or in combination with automated prompts and reminders outperformed automated approaches alone.",['Participants were 1767 adults aged 50 to 75 eyars who were not up-to-date with colorectal cancer screening recommendations at a participating community health center clinic'],"['text message prompt and 2 automated phone call reminders (automated condition); (2) up to 3 live call reminders (live condition); or (3) a text message prompt, 2 automated call reminders, and up to 3 live reminders (combined automated plus live condition']","['FIT completion rates', 'number of kits needed to mail to achieve a completed FIT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0337645', 'cui_str': 'Living Conditions'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",1767.0,0.134006,"Among unscreened individuals in this population, live phone call reminders either alone or in combination with automated prompts and reminders outperformed automated approaches alone.","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC). Gloria.D.Coronado@kpchr.org.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Denis B', 'Initials': 'DB', 'LastName': 'Nyongesa', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Castillo', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Younger', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Escaron', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.03.180275'] 3212,31358329,Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.,"OBJECTIVE In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures. METHODS Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs. RESULTS The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165). CONCLUSIONS Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures.",2020,"The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%).","['patients undergoing isolated coronary artery bypass grafting (CABG) surgery', 'patients undergoing cardiac surgery', 'Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial', 'patients with reduced left ventricular function undergoing isolated coronary or valve surgery']","['placebo', 'levosimendan', 'Levosimendan', 'levosimendan and placebo']","['co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs', 'valve', 'LCOS', 'median and mean 30-day costs', '90-day mortality and LCOS', 'Ninety-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]",,0.314909,"The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%).","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'van Diepen', 'Affiliation': 'Division of Cardiology, Departments of Critical Care and Medicine, University of Alberta, Edmonton, Alberta, Canada; Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada. Electronic address: sv9@ualberta.ca.'}, {'ForeName': 'Rajendra H', 'Initials': 'RH', 'LastName': 'Mehta', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Leimberger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada; Terrence Donnelly Heart Centre, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Schulich Heart Center, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Tenax Therapeutics, Morrisville, NC.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heringlake', 'Affiliation': 'University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jerrold H', 'Initials': 'JH', 'LastName': 'Levy', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Luber', 'Affiliation': 'Franciscan Health System, Tacoma, Wash.'}, {'ForeName': 'A Dave', 'Initials': 'AD', 'LastName': 'Nagpal', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Andra E', 'Initials': 'AE', 'LastName': 'Duncan', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Argenziano', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Toller', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Teoh', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Ontario, Canada.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Knight', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cowper', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.06.020'] 3213,32049923,"Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial.","OBJECTIVE To assess the efficacy and safety of ultra-low dose 0.005% estriol vaginal gel in women with breast cancer receiving nonsteroidal aromatase inhibitors (NSAIs) and experiencing treatment-related vulvovaginal symptoms and signs. METHODS Women with hormone receptor-positive early breast cancer receiving NSAIs were randomized to either estriol vaginal gel or placebo for 12 weeks. Vaginal maturation, vaginal pH, and total and individual scores of symptoms and signs of vulvovaginal atrophy were assessed at baseline and at weeks 3 and 12; sexual functioning was also evaluated using the Female Sexual Functioning Index (FSFI) questionnaire, as well as circulating estrogens, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). RESULTS Sixty-one women with a mean age of 59 years were included: 50 received 0.005% estriol vaginal gel and 11 received placebo. Active treatment significantly improved maturation value and pH, vaginal dryness and global scores of symptoms and signs. Active treatment also increased the total FSFI score and all the FSFI domains, with the exception of pain. Small oscillations were observed in FSH and LH, which remained within the postmenopausal range. Estriol levels increased initially and normalized by week 12, and estradiol and estrone remained mostly undetectable throughout the study. CONCLUSIONS Ultra-low dose 0.005% estriol vaginal gel showed efficacy in improving the symptoms and signs of vulvovaginal atrophy. These results, together with minimal oscillations in hormonal levels throughout the treatment, support the use of ultra-low dose 0.005% estriol vaginal gel as a treatment option for vulvovaginal atrophy in women with breast cancer receiving NSAIs with an indication for treatment with vaginal estrogens. : Video Summary:http://links.lww.com/MENO/A531.",2020,"Active treatment significantly improved maturation value and pH, vaginal dryness and global scores of symptoms and signs.","['Sixty-one women with a mean age of 59 years were included: 50 received 0.005', 'women with breast cancer receiving', 'women with breast cancer receiving nonsteroidal aromatase inhibitors (NSAIs) and experiencing treatment-related vulvovaginal symptoms and signs', 'postmenopausal women with early breast cancer treated with', 'Women with hormone receptor-positive early breast cancer receiving NSAIs']","['estriol vaginal gel', 'ultra-low dose 0.005% estriol vaginal gel', 'nonsteroidal aromatase inhibitors', 'placebo', ' Video Summary:http://links.lww.com/MENO/A531', 'NSAIs', 'estriol vaginal gel or placebo']","['Female Sexual Functioning Index (FSFI) questionnaire, as well as circulating estrogens, follicle-stimulating hormone (FSH) and luteinizing hormone (LH', 'efficacy and safety', 'maturation value and pH, vaginal dryness and global scores of symptoms and signs', 'Estriol levels', 'symptoms and signs of vulvovaginal atrophy', 'Efficacy and safety', 'vulvovaginal atrophy', 'total FSFI score', 'Vaginal maturation, vaginal pH, and total and individual scores of symptoms and signs of vulvovaginal atrophy', 'estradiol and estrone']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0042257', 'cui_str': 'Vaginal Jelly'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",61.0,0.0495493,"Active treatment significantly improved maturation value and pH, vaginal dryness and global scores of symptoms and signs.","[{'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institute and Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sánchez-Rovira', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario de Jaén, Jaén, Spain. GEICAM Spanish Breast Cancer Group.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Presa-Lorite', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital Universitario de Jaén, Jaén, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Campos-Delgado', 'Affiliation': ""Department of Obstetrics and Gynecology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""Breast Cancer Unit, Institut Català d'Oncologia, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain. GEICAM Spanish Breast Cancer Group.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Lidbrink', 'Affiliation': 'Patient area Breast cancer, Endocrine tumors and Sarcoma, Department of Medical Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Suárez-Almarza', 'Affiliation': 'Medical Department, Italfarmaco, S.A., Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Nieto-Magro', 'Affiliation': 'Medical Department, Italfarmaco, S.A., Madrid, Spain.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001497'] 3214,32034814,Evaluation of pharmacokinetics and safety with bioequivalence of Amlodipine in healthy Chinese volunteers: Bioequivalence Study Findings.,"BACKGROUND AND OBJECTIVE Amlodipine, a main series of L-type calcium channel blockers (CCBs), exerts potent antihypertensive effects. The aim of this trial was to explore the pharmacokinetics (PK) and safety with bioequivalence of orally administered Amlodipine provided by two sponsors in healthy volunteers (HVs). METHODS Two separate randomized, open-label, single-dose, crossover-design studies were conducted: a fasting study (n = 24) and a fed study (n = 24). In each study, HVs were randomized to Fangming Pharmaceutical Group (Test, T) followed by NORVASC ® (Reference, R), or vice versa. Each study subject received a 5-mg Amlodipine tablet with a 15-day washout. The plasma concentrations of Amlodipine were measured using a LC-MS/MS method, and PK parameters were determined by noncompartmental model. RESULTS Forty-eight healthy volunteers were enrolled. And overall demographics were as follows: the fasting study: female (n = 16/24), age (18-54 years), weight (47-76 kg), and BMI (19.5-26.0). The fed study: female (n = 16/24), age (20-49 years), weight (45.5-69 kg), and BMI (19.1-25.0). All PK endpoints met the pre-specific criteria for PK equivalence. In fasting subjects, the maximum plasma concentration (C max ) was 3.881 ± 0.982 ng/mL at 6 hours (median) of sponsor T, and 4.042 ± 1.147 ng/mL at 6 hours (median) of sponsor R. In fed subjects, C max was 3.312 ± 0.789 ng/mL at 6 hours (median) of sponsor T, and 3.392 ± 0.902 ng/mL at 5 hours (median) of sponsor R. Both fasting and fed studies achieved a plausible bioequivalence. CONCLUSIONS Amlodipine is well tolerated and have a favorable safety profile. The observed adverse events were mild (the severity was assessed according to the Common Terminology Criteria for Adverse Events [version CTCAE4.03]) and all of them were recovered without severe sequences. And the bioequivalence is achieved under fasting and fed conditions, supporting the demonstration of biosimilarity.",2020,"In fasting subjects, the maximum plasma concentration (C max ) was 3.881 ± 0.982 ","['the fasting study: female (n\xa0=\xa016/24), age (18-54\xa0years), weight (47-76\xa0kg), and BMI (19.5-26.0', 'Forty-eight healthy volunteers', 'healthy Chinese volunteers', 'healthy volunteers (HVs', 'The fed study: female (n\xa0=\xa016/24), age (20-49\xa0years), weight (45.5-69\xa0kg), and BMI (19.1-25.0']","['Amlodipine', 'L-type calcium channel blockers (CCBs']","['maximum plasma concentration', 'adverse events', 'plasma concentrations of Amlodipine', 'pharmacokinetics (PK) and safety']","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0288263', 'cui_str': 'Long-Lasting Calcium Channels'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",48.0,0.070475,"In fasting subjects, the maximum plasma concentration (C max ) was 3.881 ± 0.982 ","[{'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Wangjiangshan Institute, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Lou', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Qigang', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""Wangjiangshan Institute, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}]",Journal of clinical laboratory analysis,['10.1002/jcla.23228'] 3215,32048278,Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial.,"Using biased-coin sequential allocation, we sought to determine the effective time interval in 90% of healthy parturients to achieve a target endpoint end-tidal oxygen of ≥ 90% using standard flow rate facemask and high-flow nasal oxygen. Eighty healthy parturients were randomly assigned to standard facemask (n = 40) or high-flow nasal oxygen (n = 40) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment. The effective time interval for 90% of parturients to achieve the target endpoint for standard facemask was 3.6 min (95%CI 3.3-6.7 min), but could not be estimated for the high-flow nasal oxygen groups with or without an additional simple facemask, as eight minutes was insufficient to achieve the target endpoint for 55% and 92% of parturients, respectively. Furthermore, after three minutes, the target endpoint was reached by 71% in the standard facemask group vs. 0% in the high-flow nasal oxygen groups. After four minutes, the target endpoint was reached by 100% in the standard facemask, 80% in the high-flow nasal oxygen with simple facemask and 67% in the high-flow nasal oxygen groups. Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen. In conclusion, under the conditions of our study, the effective time interval for 90% of parturients to achieve an end-tidal oxygen ≥ 90% for standard flow rate facemask was estimated to be 3.6 min, but could not be estimated for high-flow nasal oxygen groups even after eight minutes.",2020,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","['obstetric patients using high', 'Eighty healthy parturients']","['standard facemask (n\xa0=\xa040) or high-flow nasal oxygen (n\xa0=\xa040) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment', 'flow nasal oxygen and standard flow rate facemask', 'standard flow rate facemask and high-flow nasal oxygen']","['effective time interval', 'pre-oxygenation success']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0489449,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Au', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Shippam', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': ""Women's Health Research Institute, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chau', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}]",Anaesthesia,['10.1111/anae.14995'] 3216,32035748,Pilot Study Suggests Smartphone Application Knowledge Improves Resident Transesophageal Echocardiography Knowledge: A Randomized Controlled Trial.,"OBJECTIVE The objective of this study was to determine whether an asynchronous smartphone-based application with image-based questions would improve anesthesiology resident transesophageal echocardiography (TEE) knowledge compared with standard intraoperative teaching alone. DESIGN Prospective, single-blinded, pilot, randomized controlled trial. SETTING Large university teaching hospital. PARTICIPANTS Participants were anesthesiology residents on their cardiac anesthesiology rotation. INTERVENTIONS EchoEducator, a TEE image-based smartphone application of learning content through questions, was developed. Content was derived from the Examination of Special Competence in Basic Perioperative Transesophageal Echocardiography and the Objective Structured Clinical Examination portion of the APPLIED Examination and focused on identification of basic TEE views, cardiac structures, and pathology. Residents were randomly assigned to receive access to either the application or to standard intraoperative teaching. Thirty residents met inclusion criteria, and 18 residents completed the study. A pre-intervention assessment was given at the beginning of the rotation, and a post-intervention assessment was given after 2 weeks. MEASUREMENTS The primary outcome was the difference between the post-test score and the pre-test score. Standard bivariate statistics and the chi-square test were used for categorical variables, and the Student t test was used for continuous variables. Tests were 2-sided, and statistical significance was set at p < 0.05. The intervention group demonstrated a greater increase in score; (+19.19% [95% confidence interval 4.14%-34.24%]; p = 0.02) compared with the control group. CONCLUSIONS This study supports the hypothesis that use of a smartphone-based asynchronous educational application improves TEE knowledge compared with traditional modalities alone. This supports an opportunity to improve medical education by expanding the role of web-based asynchronous learning.",2020,"The intervention group demonstrated a greater increase in score; (+19.19% [95% confidence interval 4.14%-34.24%]; p = 0.02) compared with the control group. ","['Thirty residents met inclusion criteria, and 18 residents completed the study', 'Participants were anesthesiology residents on their cardiac anesthesiology rotation', 'Large university teaching hospital']","['standard intraoperative teaching alone', 'asynchronous smartphone-based application with image-based questions', 'smartphone-based asynchronous educational application', 'standard intraoperative teaching']","['score', 'TEE knowledge', 'post-test score and the pre-test score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.141162,"The intervention group demonstrated a greater increase in score; (+19.19% [95% confidence interval 4.14%-34.24%]; p = 0.02) compared with the control group. ","[{'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Linganna', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA; Thomas Jefferson University Hospital, Philadelphia, PA. Electronic address: Regina.Linganna@jefferson.edu.'}, {'ForeName': 'Saumil J', 'Initials': 'SJ', 'LastName': 'Patel', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Lourdes Al', 'Initials': 'LA', 'LastName': 'Ghofaily', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Mackay', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Spelde', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Elizabeth Y', 'Initials': 'EY', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Kukafka', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Feinman', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Augoustides', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hopstial of the University of Pennsylvania, Philadelphia, PA.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.12.051'] 3217,31941354,"Survival After Intravenous Versus Intraosseous Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Shock-Refractory Cardiac Arrest.","BACKGROUND Antiarrhythmic drugs have not proven to significantly improve overall survival after out-of-hospital cardiac arrest from shock-refractory ventricular fibrillation/pulseless ventricular tachycardia. How this might be influenced by the route of drug administration is not known. METHODS In this prespecified analysis of a randomized, placebo-controlled clinical trial, we compared the differences in survival to hospital discharge in adults with shock-refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest who were randomly assigned by emergency medical services personnel to an antiarrhythmic drug versus placebo in the ALPS trial (Resuscitation Outcomes Consortium Amiodarone, Lidocaine or Placebo Study), when stratified by the intravenous versus intraosseous route of administration. RESULTS Of 3019 randomly assigned patients with a known vascular access site, 2358 received ALPS drugs intravenously and 661 patients by the intraosseous route. Intraosseous and intravenous groups differed in sex, time-to-emergency medical services arrival, and some cardiopulmonary resuscitation characteristics, but were similar in others, including time-to-intravenous/intrasosseous drug receipt. Overall hospital discharge survival was 23%. In comparison with placebo, discharge survival was significantly higher in recipients of intravenous amiodarone (adjusted risk ratio, 1.26 [95% CI, 1.06-1.50]; adjusted absolute survival difference, 5.5% [95% CI, 1.5-9.5]) and intravenous lidocaine (adjusted risk ratio, 1.21 [95% CI, 1.02-1.45]; adjusted absolute survival difference, 4.7% [95% CI, 0.7-8.8]); but not in recipients of intraosseous amiodarone (adjusted risk ratio, 0.94 [95% CI, 0.66-1.32]) or intraosseous lidocaine (adjusted risk ratio, 1.03 [95% CI, 0.74-1.44]). Survival to hospital admission also increased significantly when drugs were given intravenously but not intraosseously, and favored improved neurological outcome at discharge. There were no outcome differences between intravenous and intraosseous placebo, indicating that the access route itself did not demarcate patients with poor prognosis. The study was underpowered to assess intravenous/intraosseous drug interactions, which were not statistically significant. CONCLUSIONS We found no significant effect modification by drug administration route for amiodarone or lidocaine in comparison with placebo during out-of-hospital cardiac arrest. However, point estimates for the effects of both drugs in comparison with placebo were significantly greater for the intravenous than for the intraosseous route across virtually all outcomes and beneficial only for the intravenous route. Given that the study was underpowered to statistically assess interactions, these findings signal the potential importance of the drug administration route during resuscitation that merits further investigation.",2020,We found no significant effect modification by drug administration route for amiodarone or lidocaine compared to placebo during OHCA.,"['adults with shock-refractory VF/VT OHCA who were randomized by emergency medical services (EMS) personnel to an', '3,019 randomized patients with known vascular access site', 'and 661 patients by IO route']","['placebo', 'IO lidocaine', 'IO amiodarone', 'Amiodarone, Lidocaine or Placebo', 'IO placebo', 'ALPS drugs IV', 'Amiodarone, Lidocaine or Placebo Study (ALPS', 'lidocaine', 'antiarrhythmic drug versus placebo', 'amiodarone']","['Survival to hospital admission', 'neurological outcome', 'Survival', 'Overall hospital discharge survival', 'survival to hospital discharge', 'absolute survival difference', 'discharge survival', 'overall survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003195', 'cui_str': 'Anti-Arrhythmics'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",3019.0,0.479938,We found no significant effect modification by drug administration route for amiodarone or lidocaine compared to placebo during OHCA.,"[{'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Department of Emergency Medicine (M.R.D., J.R.L.), Oregon Health & Science University, Portland.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Leroux', 'Affiliation': 'Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (B.G.L.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Division of Cardiology (P.D.), St Michael's Hospital, University of Toronto, Canada.""}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Rea', 'Affiliation': 'Department of Medicine (T.D.R.), University of Washington, Seattle.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Newgard', 'Affiliation': 'Center for Policy and Research in Emergency Medicine, Department of Emergency Medicine (C.D.N.), Oregon Health & Science University, Portland.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': ""Rescu, Li Ka Shing Knowledge Institute (L.J.M.), St Michael's Hospital, University of Toronto, Canada.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Department of Emergency Medicine (M.R.D., J.R.L.), Oregon Health & Science University, Portland.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Menegazzi', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, PA (J.J.M.).'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Ornato', 'Affiliation': 'Virginia Commonwealth University Health System, Richmond (J.P.O.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.S.).'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': 'Department of Emergency Medicine (J.C.).'}, {'ForeName': 'Ahamed', 'Initials': 'A', 'LastName': 'Idris', 'Affiliation': 'Departments of Emergency Medicine and Internal Medicine (A.I.), UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Mody', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M.), UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California San Diego (G.M.V.).'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Herdeman', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee (C.H.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barbic', 'Affiliation': 'University of British Columbia, Vancouver, Canada (D.B.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kudenchuk', 'Affiliation': 'Department of Medicine, Division of Cardiology (P.J.K.), University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042240'] 3218,31971325,Mindfetalness to increase women's awareness of fetal movements and pregnancy outcomes: a cluster-randomised controlled trial including 39 865 women.,"OBJECTIVE To examine whether a method for raising women's awareness of fetal movements, Mindfetalness, can affect pregnancy outcomes. DESIGN Cluster-randomised controlled trial. SETTING Sixty-seven maternity clinics in Stockholm, Sweden. POPULATION Women with singleton pregnancy with birth from 32 weeks' gestation. METHODS Women registered at a clinic randomised to Mindfetalness were assigned to receive a leaflet about Mindfetalness (n = 19 639) in comparison with routine care (n = 20 226). Data were collected from a population-based register. MAIN OUTCOME MEASURES Apgar score <7 at 5 minutes after birth, visit to healthcare due to decrease in fetal movements. Other outcomes: Apgar score <4 at 5 minutes after birth, small-for-gestational-age and mode of delivery. RESULTS No difference (1.1 versus 1.1%, relative risk [RR] 1.0; 95% CI 0.8-1.2) was found between the Mindfetalness group and the Routine care group for a 5-minute Apgar score <7. Women in the Mindfetalness group contacted healthcare more often due to decreased fetal movements (6.6 versus 3.8%, RR 1.72; 95% CI 1.57-1.87). Mindfetalness was associated with a reduction of babies born small-for-gestational-age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41 +6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0 versus 20.0%, RR 0.95; 95% CI 0.91-0.99). CONCLUSIONS Mindfetalness did not reduce the number of babies born with an Apgar score <7. However, Mindfetalness was associated with the health benefits of decreased incidence of caesarean section and fewer children born small-for-gestational-age. TWEETABLE ABSTRACT Introducing Mindfetalness in maternity care decreased caesarean sections but had no effect on the occurrence of Apgar scores <7.",2020,"Mindfetalness was associated with a reduction of babies born small for gestational age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41+6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0% versus 20.0%, RR 0.95; 95% CI 0.91-0.99). ","['39\xa0865 women', 'Women registered at a clinic randomised to Mindfetalness', ""Women with singleton pregnancy with birth from 32 weeks' gestation"", 'Sixty-seven maternity clinics in Stockholm, Sweden']",['leaflet about Mindfetalness (n=19\xa0639) in comparison to routine care'],"['caesarean sections', 'reduction of babies born small for gestational age', 'fetal movements', 'Rate Ratio', 'fetal movements and pregnancy outcomes', 'number of babies born with an Apgar score', 'caesarean section']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1274026', 'cui_str': 'Maternity clinic'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0015946', 'cui_str': 'Fetal Activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",,0.222127,"Mindfetalness was associated with a reduction of babies born small for gestational age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41+6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0% versus 20.0%, RR 0.95; 95% CI 0.91-0.99). ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Akselsson', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet, Sophiahemmet University, Stockholm, Sweden.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Georgsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, The Swedish Red Cross University College, Stockholm, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pettersson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Steineck', 'Affiliation': 'Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Skokic', 'Affiliation': 'Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Rådestad', 'Affiliation': 'Sophiahemmet University, Stockholm, Sweden.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16104'] 3219,32031887,"Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303.","Background: We conducted a multicenter, randomized trial of early integrated palliative and oncology care in patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies. Methods: We randomly assigned patients with newly diagnosed incurable cancer to early integrated palliative and oncology care ( n  = 195) or usual oncology care ( n  = 196) at sites through the Alliance for Clinical Trials in Oncology. Patients assigned to the intervention were expected to meet with a PC clinician at least monthly until death, whereas usual care patients consulted PC on request. The primary endpoint was the change in quality of life from baseline to week 12 per the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes included anxiety, depression, and communication about prognosis and end-of-life care. Results: Due to significant morbidity and a high proportion of measures that were not completed within the protocol window or for unknown reasons, the rate of missing data was high. We anticipated that 70% of patients ( n  = 280) would complete the FACT-G at baseline and week 12, but only 49.3% ( n  = 193/391) completed the measure. Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12. Intervention patients reported a mean 3.35 (standard deviation [SD] = 14.7) increase in FACT-G scores from baseline to week 12 compared with usual care patients who reported a 0.12 (SD = 12.7) increase from baseline ( p  = 0.10). Conclusion: This study highlights the difficulties of conducting multicenter trials of supportive care interventions in patients with advanced cancer. Clinical Trials Registration: NCT02349412.",2020,"Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12.","['patients with advanced cancer', 'patients with newly diagnosed incurable cancer to early integrated palliative and oncology care ( n \u2009=\u2009195) or usual oncology care ( n \u2009=\u2009196) at sites through the Alliance for Clinical Trials in Oncology', 'Patients with Advanced Lung and Gastrointestinal Cancer', 'patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies']","['Early Integrated Palliative and Oncology Care', 'early integrated palliative and oncology care', 'supportive care interventions']","['FACT-G scores', 'Functional Assessment of Cancer Therapy-General (FACT-G', 'change in quality of life', 'anxiety, depression, and communication about prognosis and end-of-life care', 'PC visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}]",,0.147398,"Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Jackson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Kamal', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Blinderman', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Strand', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Zylla', 'Affiliation': 'Park Nicollet/HealthPartners, Metro-Minnesota Community Oncology Research Consortium, Minneapolis, Minnesota.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Daugherty', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Muhummad', 'Initials': 'M', 'LastName': 'Furqan', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, Iowa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Obel', 'Affiliation': 'NorthShore University HealthSystem CCOP, Evanston, Illinois.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Razaq', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roeland', 'Affiliation': 'University of California San Diego Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0377'] 3220,32043304,Enteral hydration in high-flow therapy for infants with bronchiolitis: Secondary analysis of a randomised trial.,"AIM Nasal high-flow oxygen therapy is increasingly used in infants for supportive respiratory therapy in bronchiolitis. It is unclear whether enteral hydration is safe in children receiving high-flow. METHODS We performed a planned secondary analysis of a multi-centre, randomised controlled trial of infants aged <12 months with bronchiolitis and an oxygen requirement. Children were assigned to treatment with either high-flow or standard-oxygen therapy with optional rescue high-flow. We assessed adverse events based on how children on high-flow were hydrated: intravenously (IV), via bolus or continuous nasogastric tube (NGT) or orally. RESULTS A total of 505 patients on high-flow via primary study assignment (n = 408), primary treatment (n = 10) or as rescue therapy (n = 87) were assessed. While on high flow, 15 of 505 (3.0%) received only IV fluids, 360 (71.3%) received only enteral fluids and 93 (18.4%) received both IV and enteral fluids. The route was unknown in 37 (7.3%). Of the 453 high-flow infants hydrated enterally patients could receive one or more methods of hydration; 80 (15.8%) received NGT bolus, 217 (43.0%) NGT continuous, 118 (23.4%) both bolus and continuous, 32 (6.3%) received only oral hydration and 171 (33.9%) a mix of NGT and oral hydration. None of the patients receiving oral or NGT hydration on high-flow sustained pulmonary aspiration (0%; 95% confidence interval N/A); one patient had a pneumothorax (0.2%; 95% confidence interval 0.0-0.7%). CONCLUSIONS The vast majority of children with hypoxic respiratory failure in bronchiolitis can be safely hydrated enterally during the period when they receive high-flow.",2020,"None of the patients receiving oral or NGT hydration on high-flow sustained pulmonary aspiration (0%; 95% confidence interval N/A); one patient had a pneumothorax (0.2%; 95% confidence interval 0.0-0.7%). ","['children receiving high-flow', 'infants with bronchiolitis', 'infants for supportive respiratory therapy in bronchiolitis', 'children with hypoxic respiratory failure in bronchiolitis', 'infants aged <12\u2009months with bronchiolitis and an oxygen requirement', '505 patients on high-flow via primary study assignment (n = 408), primary treatment (n = 10) or as rescue therapy (n = 87) were assessed']","['Enteral hydration', 'Nasal high-flow oxygen therapy', 'NGT and oral hydration', 'NGT', 'continuous nasogastric tube (NGT) or orally', 'high-flow or standard-oxygen therapy with optional rescue high-flow']","['pneumothorax', 'high-flow sustained pulmonary aspiration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0035239', 'cui_str': 'Respiratory Therapy'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0700198', 'cui_str': 'Pulmonary aspiration (finding)'}]",87.0,0.338205,"None of the patients receiving oral or NGT hydration on high-flow sustained pulmonary aspiration (0%; 95% confidence interval N/A); one patient had a pneumothorax (0.2%; 95% confidence interval 0.0-0.7%). ","[{'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': ""Pediatric Critical Care Research Group, Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Dalziel', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Furyk', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': ""Pediatric Critical Care Research Group, Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': ""Pediatric Critical Care Research Group, Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of paediatrics and child health,['10.1111/jpc.14799'] 3221,31770148,Positive End-expiratory Pressure and Distribution of Ventilation in Pneumoperitoneum Combined with Steep Trendelenburg Position.,"BACKGROUND Pneumoperitoneum and a steep Trendelenburg position during robot-assisted laparoscopic prostatectomy have been demonstrated to promote a cranial shift of the diaphragm and the formation of atelectasis in the dorsal parts of the lungs. However, neither an impact of higher positive end-expiratory pressure (PEEP) on preserving the ventilation in the dorsal region nor its physiologic effects have been fully examined. The authors hypothesized that PEEP of 15 cm H2O during robot-assisted laparoscopic prostatectomy might maintain ventilation in the dorsal parts and thus improve lung mechanics. METHODS In this randomized controlled study, 48 patients undergoing robot-assisted laparoscopic prostatectomy were included in the analysis. Patients were assigned to the conventional PEEP (5 cm H2O) group or the high PEEP (15 cm H2O) group. Regional ventilation was monitored using electrical impedance tomography before and after the establishment of pneumoperitoneum and 20° Trendelenburg position during the surgery. The primary endpoint was the regional ventilation in the dorsal parts of the lungs while the secondary endpoints were lung mechanics and postoperative lung function. RESULTS Compared to that in the conventional PEEP group, the fraction of regional ventilation in the most dorsal region was significantly higher in the high PEEP group during pneumoperitoneum and Trendelenburg position (mean values at 20 min after taking Trendelenburg position: conventional PEEP, 5.5 ± 3.9%; high PEEP, 9.9 ± 4.7%; difference, -4.5%; 95% CI, -7.4 to -1.6%; P = 0.004). Concurrently, lower driving pressure (conventional PEEP, 14.9 ± 2.5 cm H2O; high PEEP, 11.5 ± 2.8 cm H2O; P < 0.001), higher lung dynamic compliance, and better oxygenation were demonstrated in the high PEEP group. Postoperative lung function did not differ between the groups. CONCLUSIONS Application of a PEEP of 15 cm H2O resulted in more homogeneous ventilation and favorable physiologic effects during robot-assisted laparoscopic prostatectomy but did not improve postoperative lung function.",2020,"Compared to that in the conventional PEEP group, the fraction of regional ventilation in the most dorsal region was significantly higher in the high PEEP group during pneumoperitoneum and Trendelenburg position (mean values at 20 min after taking Trendelenburg position: conventional PEEP, 5.5 ± 3.9%; high PEEP, 9.9 ± 4.7%; difference, -4.5%; 95% CI, -7.4 to -1.6%; P = 0.004).","['48 patients undergoing', 'patients undergoing']","['conventional PEEP (5\u2009cm H2O) group or the high PEEP', 'robot-assisted laparoscopic prostatectomy, 15 but not 5\u2009cm H2O of positive end-expiratory pressure increased ventilation', 'Pneumoperitoneum Combined with Steep Trendelenburg Position', 'conventional PEEP', 'robot-assisted laparoscopic prostatectomy', 'Pneumoperitoneum and a steep Trendelenburg position during robot-assisted laparoscopic prostatectomy']","['Positive End-expiratory Pressure and Distribution of Ventilation', 'lower driving pressure', 'Postoperative lung function', 'normal lung mechanics and gas exchangeHigh positive end-expiratory pressure', 'postoperative lung function', 'homogeneous ventilation and favorable physiologic effects', 'higher lung dynamic compliance, and better oxygenation', 'Regional ventilation', 'higher positive end-expiratory pressure (PEEP', 'regional ventilation in the dorsal parts of the lungs while the secondary endpoints were lung mechanics and postoperative lung function', 'fraction of regional ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0419024', 'cui_str': 'Positive end expiratory pressure increased (procedure)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0277812', 'cui_str': 'Trendelenburg Position'}]","[{'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0231933', 'cui_str': 'Distribution of ventilation, function (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0442054', 'cui_str': 'Dorsal part (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",48.0,0.0695563,"Compared to that in the conventional PEEP group, the fraction of regional ventilation in the most dorsal region was significantly higher in the high PEEP group during pneumoperitoneum and Trendelenburg position (mean values at 20 min after taking Trendelenburg position: conventional PEEP, 5.5 ± 3.9%; high PEEP, 9.9 ± 4.7%; difference, -4.5%; 95% CI, -7.4 to -1.6%; P = 0.004).","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Shono', 'Affiliation': 'From the Department of Anesthesiology, Shimane University, Faculty of Medicine, Izumo, Japan (A.S., N.K., T.F., K.U., T.N., Y.S.) the Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Center, Rostock, Germany (S.H.B., A.D.W.).'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Katayama', 'Affiliation': ''}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Fujihara', 'Affiliation': ''}, {'ForeName': 'Stephan H', 'Initials': 'SH', 'LastName': 'Böhm', 'Affiliation': ''}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Waldmann', 'Affiliation': ''}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ugata', 'Affiliation': ''}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Nikai', 'Affiliation': ''}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003062'] 3222,30499871,Comparison of Perioperative Systemic Lidocaine or Systemic Ketamine in Acute Pain Management of Patients With Opioid Use Disorder After Orthopedic Surgery.,"INTRODUCTION AND AIMS Patients with opioid use disorder experience great challenges during acute pain management due to opioid tolerance or withdrawal symptoms. Previous studies have recommended the use of adjuvant drugs in these patients. In this study, we compared the effect of intraoperative lidocaine with ketamine in postoperative pain management of these patients. DESIGN AND METHODS In this randomized clinical trial, 180 patients with opioid use disorder who underwent orthopedic surgery under general anesthesia were randomly allocated into 3 groups. Patients in groups A, B, and C received intravenous lidocaine, ketamine, or normal saline, respectively, during the operation. Then, postoperative pain scores, analgesic requirements, patient satisfaction, and patient sleepiness were recorded and compared among the 3 groups. RESULTS Numerical rating scales during the first hour postoperation were significantly lower in the lidocaine group than in the ketamine or control group (P < 0.001). The mean total amount of morphine consumption during the first 24-hour postoperation was 14.49 ± 26.89, 16.59 ± 30.65, and 21.72 ± 43.29 mg in the lidocaine, ketamine, and control group, respectively, being significantly lower in the lidocaine group in comparison with the other groups (P < 0.001). Patients in the lidocaine group were less restless, calmer, and less drowsy than patients in the ketamine and control group (P < 0.001). DISCUSSION AND CONCLUSION According to these findings, systemic lidocaine is more effective than systemic ketamine to improve the quality of acute pain management without causing any significant complications in patients with opioid use disorder.",2019,"RESULTS Numerical rating scales during the first hour postoperation were significantly lower in the lidocaine group than in the ketamine or control group (P < 0.001).","['Patients With Opioid Use Disorder After Orthopedic Surgery', '180 patients with opioid use disorder who underwent orthopedic surgery under general anesthesia', 'patients with opioid use disorder', 'postoperative pain management of these patients']","['intraoperative lidocaine', 'ketamine', 'lidocaine, ketamine', 'lidocaine', 'Perioperative Systemic Lidocaine or Systemic Ketamine', 'lidocaine, ketamine, or normal saline']","['restless, calmer, and less drowsy', 'postoperative pain scores, analgesic requirements, patient satisfaction, and patient sleepiness', 'Numerical rating scales', 'mean total amount of morphine consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",180.0,0.0879599,"RESULTS Numerical rating scales during the first hour postoperation were significantly lower in the lidocaine group than in the ketamine or control group (P < 0.001).","[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sahmeddini', 'Affiliation': 'Shiraz Anesthesiology and Intensive Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Khosravi', 'Affiliation': ''}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Farbood', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000483'] 3223,31930364,Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial.,"Importance RimabotulinumtoxinB (RIMA) may be preferable as an anti-sialorrhea treatment compared with current oral anticholinergic drugs in people with neurological disorders. Objective To assess the safety, efficacy, and tolerability of RIMA injections for the treatment of sialorrhea in adults. Design, Setting, and Participants This randomized, parallel, double-blind, placebo-controlled clinical trial of RIMA 2500 U and 3500 U was conducted from November 14, 2013, to January 23, 2017. A total of 249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened. Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled. Patients had to have a minimum unstimulated salivary flow rate (USFR) of 0.2 g/min and a minimum Drooling Frequency and Severity Scale score of 4. Exposures Patients were randomized 1:1:1 to RIMA, 2500 U (n = 63); RIMA, 3500 U (n = 64); or placebo (n = 60). Main Outcomes and Measures Primary outcomes were the change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C) at week 4. The CGI-C scores were recorded on a 7-point scale ranging from very much improved to very much worse. Adverse events were recorded throughout the trial period. Results Of 187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years), 122 patients had Parkinson disease (65.2%), 13 (7.0%) were stroke survivors, 12 had amyotrophic lateral sclerosis (6.4%), 6 had medication-induced sialorrhea (3.2%), 4 had adult cerebral palsy (2.1%), and 30 had sialorrhea owing to other causes (16.0%). A total of 176 completed the study. Treatment with both doses of RIMA significantly reduced USFR at week 4 vs placebo (mean treatment difference, -0.30 g/min [95% CI, -0.39 to -0.21] for both doses vs placebo, P < .001). The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14 [95% CI, -1.49 to -0.80] for 3500 U, both P < .001). Treatment benefits were seen as early as 1 week after injection and were maintained over the treatment cycle of approximately 13 weeks. The RIMA injections were well tolerated compared with placebo. The most common adverse events were self-limited mild to moderate dry mouth, dysphagia, and dental caries. Conclusions and Relevance Treatment with RIMA (2500 U and 3500 U) in adults was well tolerated and reduced sialorrhea, with the onset of the effect at 1 week after the injection. These data support the clinical use of RIMA in the management of sialorrhea in adults. Trial Registration ClinicalTrials.gov Identifier: NCT01994109.",2020,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","['187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years', 'A total of 176 completed the study', '122 patients had Parkinson disease (65.2%), 13 (7.0', 'Sialorrhea in Adults', '249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened', 'Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled', 'people with neurological disorders', 'sialorrhea in adults']","['RIMA', 'RIMA injections', 'RimabotulinumtoxinB', 'placebo', 'RimabotulinumtoxinB (RIMA']","['adult cerebral palsy', 'amyotrophic lateral sclerosis', 'Safety and Efficacy', 'change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C', 'tolerated and reduced sialorrhea', 'Adverse events', 'safety, efficacy, and tolerability', 'CGI-C scores', 'USFR', 'minimum Drooling Frequency and Severity Scale score of 4', 'minimum unstimulated salivary flow rate (USFR']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2719430', 'cui_str': 'rimabotulinumtoxinB'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated (qualifier value)'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate (observable entity)'}]",249.0,0.347529,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","[{'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, Florida.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ondo', 'Affiliation': 'Houston Methodist Neurological Institute, Houston, Texas.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'The University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Trosch', 'Affiliation': 'Franklin Neurology, Farmington Hills, Michigan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Molho', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center, Albany Medical Center, Albany, New York.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lew', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Dashtipour', 'Affiliation': 'Loma Linda University Schools of Medicine and Pharmacy, Loma Linda, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clinch', 'Affiliation': 'US WorldMeds LLC, Louisville, Kentucky.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.4565'] 3224,32044174,Comparison of clinically used bilayer collagen membrane and trilayer collagen prototype fixation stability in chondral defects at the talus - An experimental human specimen study.,"BACKGROUND The purpose of this human specimen experimental study was to compare the fixation stability of clinically used bilayer collagen membrane with fibrin glue with trilayer collagen prototype without fibrin glue in chondral defects at the medial or lateral talar shoulder (both matrices from Geistlich Pharma AG, Wollhusen, Switzerland). METHODS Eleven human specimens were used. The membranes were implanted in standardized chondral defects at the medial and lateral talar shoulder randomized. All tests were performed in load-control 15 kg. Range of motion ROM of each ankle was examined individually before testing. The average ROM was 10° dorsiflexion range 0°-20° and 30° plantarflexion range 20°-45°. 1,000 testing cycles with the defined ROM were performed. Two independent investigators, blinded to membrane and fixation type, visually assessed the membrane fixation integrity for peripheral detachment, area of defect uncovered, membrane constitution and delamination. RESULTS The clinically used bilayer collagen membrane plus fibrin glue showed higher fixation stability than the trilayer prototype (all p < 0.05). No significant differences occurred between medial and lateral talar shoulder location (all p > 0.05). CONCLUSIONS The fixation stability of the trilayer collagen prototype without fibrin glue is lower than of the clinically used bilayer membrane with fibrin glue in chondral defects at the medial and lateral talar shoulder in an experimental human specimen test. Clinical use of trilayer collagen prototype without fibrin glue has to be validated by clinical testing to evaluate if the lower stability of fixation is still sufficient.",2020,The clinically used bilayer collagen membrane plus fibrin glue showed higher fixation stability than the trilayer prototype (all p < 0.05).,"['° and 30° plantarflexion range', 'Eleven human specimens were used', '20°-45']","['fibrin glue (Chondro-Gide, Geistlich Pharma AG, Wollhusen, Switzerland) with trilayer collagen prototype without fibrin glue', 'fibrin glue', 'bilayer collagen membrane and trilayer collagen prototype fixation stability']","['membrane fixation integrity for peripheral detachment, area of defect uncovered, membrane constitution and delamination', 'medial and lateral talar shoulder location', 'fixation stability', 'average ROM']","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0541879', 'cui_str': 'Detachment'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439845', 'cui_str': 'Uncovered (qualifier value)'}, {'cui': 'C0009807', 'cui_str': 'Constitutions'}, {'cui': 'C0441514', 'cui_str': 'Delamination (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}]",,0.027231,The clinically used bilayer collagen membrane plus fibrin glue showed higher fixation stability than the trilayer prototype (all p < 0.05).,"[{'ForeName': 'Martinus', 'Initials': 'M', 'LastName': 'Richter', 'Affiliation': 'Department for Foot and Ankle Surgery Rummelsberg and Nuremberg, Germany(2). Electronic address: martinus.richter@sana.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Milstrey', 'Affiliation': 'Department of Trauma-, Hand and Reconstructive Surgery, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zech', 'Affiliation': 'Department for Foot and Ankle Surgery Rummelsberg and Nuremberg, Germany(2).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Evers', 'Affiliation': 'Department of Trauma-, Hand and Reconstructive Surgery, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Grueter', 'Affiliation': 'Department of Trauma-, Hand and Reconstructive Surgery, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Raschke', 'Affiliation': 'Department of Trauma-, Hand and Reconstructive Surgery, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Ochman', 'Affiliation': 'Department of Trauma-, Hand and Reconstructive Surgery, University of Muenster, Muenster, Germany.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.01.007'] 3225,31343446,"Efficacy, Patient-Reported Outcomes, and Safety in Male Subjects Treated With OnabotulinumtoxinA for Improvement of Moderate to Severe Horizontal Forehead Lines.","BACKGROUND Men represent a growing segment of the facial aesthetic market. OBJECTIVE To evaluate investigator-assessed efficacy, patient-reported outcomes, and safety after onabotulinumtoxinA treatment of forehead lines (FHL) in men. METHODS Subjects with moderate to severe FHL received onabotulinumtoxinA (frontalis: 20 U; glabellar complex: 20 U, with/without 24 U in crow's feet regions) or placebo in 6-month, double-blind periods of 2 pivotal trials. Results for men were pooled. RESULTS Men comprised 12% (140/1,178) of subjects. Day 30 male responder rates for achieving at least 1-grade Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150. Despite men having proportionately more severe FHL at baseline, 81.8% and 79.8% achieved Day 30 FWS ratings of none or mild at maximum eyebrow elevation and at rest, respectively (p < .05); significance versus placebo was maintained through Day 120. Men reported high satisfaction rates and improved psychological impacts. No new safety signals were detected. CONCLUSION Standard dosing and administration of onabotulinumtoxinA significantly improved static and dynamic FHL appearance, despite men having proportionately more severe FHL at baseline. Men reported high satisfaction and appearance-related psychological impact improvements.",2020,"Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150.","['Subjects with moderate to severe FHL received', 'Male Subjects Treated With', 'Day 30 male responder rates for achieving at least 1-grade', 'Men comprised 12% (140/1,178) of subjects', 'forehead lines (FHL) in men']","['onabotulinumtoxinA', 'placebo', 'OnabotulinumtoxinA', ""onabotulinumtoxinA (frontalis: 20 U; glabellar complex: 20 U, with/without 24 U in crow's feet regions) or placebo""]","['Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation', 'satisfaction rates and improved psychological impacts', 'static and dynamic FHL appearance', 'severe FHL', 'responder rates']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0262478', 'cui_str': 'Wrinkled face (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0015420', 'cui_str': 'Eyebrows'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",30.0,0.212587,"Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150.","[{'ForeName': 'Terrence C', 'Initials': 'TC', 'LastName': 'Keaney', 'Affiliation': 'SkinDC, Arlington, Virginia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cavallini', 'Affiliation': 'Servizio di Chirurgia Plastica, Centro Diagnostico Italiano, Milan, Italy.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leys', 'Affiliation': 'Medical Skincare, Sint-Truiden, Belgium.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Drinkwater', 'Affiliation': 'Peloton Advantage, Parsippany, New Jersey.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Manson Brown', 'Affiliation': 'Allergan Limited, Marlow, Buckinghamshire, United Kingdom.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Garcia', 'Affiliation': 'Allergan Plc, Irvine, California.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Allergan Plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002047'] 3226,32045951,Heart Rate During an Exercise Test and Acute High-intensity Interval Training in Type 2 Diabetes.,"To describe and compare the acute heart rate changes during an incremental exercise test and high-intensity interval training (HIIT) in subjects of different glucose control. Seventy-five adults were allocated into three groups: Normoglycaemic (NG, n= 32), Pre- (PreT2D, n= 30) and Type 2 diabetic (T2D, n= 13) subjects. Subjects performed an incremental cycling test to determine cardiorespiratory fitness (VO 2 max), maximum heart rate (HRmax) and HR recovery post maximal effort, as well as a HIIT cycling session. HR variations are reported as HR pre (HR-pre INT ), and post interval (HR-post INT ), percentage of maximum HR (%HRmax), delta of HR increased (∆HR INT ), and delta HR recovery after each interval (∆HRR). By groups, there was a significant difference for the %HRmax in 1 st and 2 nd , but not in intervals 3 rd to 10 th between Pre-T2D and T2D groups. There were significant differences for the %HRmax in 1 st to 2 nd intervals between Pre-T2D and T2D groups. Significant ( P< 0.05) differences at some intervals were found for ΔHR INT , and ΔHRR. These findings suggest that the HR during an incremental exercise test, and from a typical 10-intervals based HIIT protocol could be used as an intensity marker for individuals independent of their glycaemic control.",2020,"Significant ( P< 0.05) differences at some intervals were found for ΔHR INT , and ΔHRR.","['Type 2 Diabetes', 'Seventy-five adults', 'subjects of different glucose control', 'PreT2D, n= 30) and Type 2 diabetic (T2D, n= 13) subjects']","['Pre', 'incremental exercise test and high-intensity interval training (HIIT', 'Interval Training']","['Heart Rate', 'HR pre (HR-pre INT ), and post interval (HR-post INT ), percentage of maximum HR (%HRmax), delta of HR increased (∆HR INT ), and delta HR recovery', 'Acute High-intensity', 'cardiorespiratory fitness (VO 2 max), maximum heart rate (HRmax) and HR recovery post maximal effort, as well as a HIIT cycling session']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",75.0,0.023136,"Significant ( P< 0.05) differences at some intervals were found for ΔHR INT , and ΔHRR.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Andrade-Mayorga', 'Affiliation': 'Department of Preclinical Sciences, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Mancilla', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Department of Human Movement Science, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Díaz', 'Affiliation': 'Physical Education, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Quality of Life and Wellness Research Group, Department of Physical Activity Sciences, Laboratory of Human Performance, Universidad de Los Lagos, Chile.'}]",International journal of sports medicine,['10.1055/a-1015-0591'] 3227,31825499,Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial.,"Importance Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients. Objective To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care. Design, Setting, and Participants Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018. Interventions Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations. Main Outcomes and Measures The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality. Results In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods. Conclusions and Relevance An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes. Trial Registration ClinicalTrials.gov identifier: NCT02577198.",2019,"In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59).","['Clinician Recommendations and Patient Outcomes', '6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control', 'The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men', 'Between November 1, 2015, and December 31, 2016, patients', '20\u202f563 patients were admitted to the hospital']","['Hospital-Based Computerized Decision Support System', 'computerized clinical decision support system (CDSS']","['length of hospital stay and in-hospital all-cause mortality', 'resolution rate', 'length of hospital stay', 'Alert fatigue', 'resolution rate, the rate at which medical problems identified and alerted by the CDSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]",20563.0,0.158738,"In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59).","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Moja', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Polo Friz', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Capobussi', 'Affiliation': 'Clinical Epidemiology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Orthopedic Institute Galeazzi, Milan, Italy.'}, {'ForeName': 'Koren', 'Initials': 'K', 'LastName': 'Kwag', 'Affiliation': 'Medical School of International Health, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Banzi', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ruggiero', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Marien', 'Initials': 'M', 'LastName': 'González-Lorenzo', 'Affiliation': 'Humanitas Clinical and Research Center, Milan, Italy.'}, {'ForeName': 'Elisa G', 'Initials': 'EG', 'LastName': 'Liberati', 'Affiliation': 'The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Mangia', 'Affiliation': 'Medilogy Srl, Milan, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nyberg', 'Affiliation': 'Duodecim Medical Publications Ltd, Helsinki, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kunnamo', 'Affiliation': 'Duodecim Medical Publications Ltd, Helsinki, Finland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cimminiello', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vighi', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute and the Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Delgrossi', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Bonovas', 'Affiliation': 'Humanitas Clinical and Research Center, Milan, Italy.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.17094'] 3228,32035514,"Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND Pembrolizumab plus pemetrexed-platinum led to superior overall survival and progression-free survival, and a higher proportion of patients with a confirmed complete or partial response over placebo plus pemetrexed-platinum in the KEYNOTE-189 study. We aimed to evaluate prespecified exploratory patient-reported outcomes (PROs) in patients in KEYNOTE-189. METHODS In the multicentre, double-blind, randomised, placebo-controlled, phase 3 KEYNOTE-189 study done at 126 cancer centres in 16 countries, eligible patients aged 18 years or older with histologically or cytologically confirmed metastatic non-squamous non-small-cell lung cancer without sensitising EGFR or ALK alterations, measurable disease as per Response Evaluation Criteria in Solid Tumors (version 1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled. Patients were randomly assigned (2:1) to receive intravenous pembrolizumab (200 mg) or saline placebo every 3 weeks for up to 2 years (35 cycles); all patients received four cycles of intravenous pemetrexed (500 mg/m 2 ) with carboplatin (5 mg/mL per min) or cisplatin (75 mg/m 2 ; investigator's choice) every 3 weeks for four cycles, followed by pemetrexed maintenance therapy every 3 weeks. Permuted block randomisation (block size six) was done with an interactive voice-response system and stratified by PD-L1 expression, choice of platinum, and smoking status. Patients, investigators, and other study personnel were unaware of treatment assignment. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13) were administered at cycles 1-5, every three cycles thereafter during year 1, and every four cycles during years 2-3. The primary endpoints (overall survival and progression-free survival) have been published previously. Key PRO endpoints were change from baseline to week 12 (during chemotherapy) and week 21 (following chemotherapy) in QLQ-C30 global health status/quality of life (GHS/QOL) score, and time to deterioration in cough, chest pain, or dyspnoea. PROs were analysed in all randomly assigned patients who received at least one dose of study medication and who completed at least one PRO assessment, and the results are provided with two-sided, nominal p values. This ongoing study is registered with ClinicalTrials.gov, number NCT02578680. FINDINGS Between Feb 26, 2016, and March 6, 2017, 616 patients were enrolled; median follow-up was 10·5 months (range 0·2-20·4) as of data cutoff on Nov 8, 2017. 402 (99%) of 405 patients in the pembrolizumab plus pemetrexed-platinum group and 200 (99%) of 202 patients in the placebo plus pemetrexed-platinum-treated group completed at least one PRO assessment. At baseline, 359 (89%) of 402 patients in the pembrolizumab plus pemetrexed-platinum group and 180 (90%) of 200 in the placebo plus pemetrexed-platinum group were compliant with QLQ-C30; at week 12, 319 (90%) of 354 and 149 (89%) of 167 patients were compliant, respectively; and at week 21, 249 (76%) of 326 and 91 (64%) of 143 patients were compliant, respectively. From baseline to week 12, GHS/QOL scores were maintained with both pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·0 point [95% CI -1·3 to 3·2] increase) and placebo plus pemetrexed-platinum (-2·6 points [-5·8 to 0·5] decrease; between-group difference: 3·6 points [-0·1 to 7·2]; p=0·053). From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014). Median time to deterioration in cough, chest pain, or dyspnoea was not reached (95% CI 10·2 months to not reached) with pembrolizumab plus pemetrexed-platinum, and was 7·0 months (4·8 months to not reached) with placebo plus pemetrexed-platinum (hazard ratio 0·81 [95% CI 0·60-1·09], p=0·16). INTERPRETATION The addition of pembrolizumab to standard chemotherapy maintained GHS/QOL, with improved GHS/QOL scores at week 21 in the pembrolizumab plus chemotherapy group compared with the placebo plus chemotherapy group. These data further support use of pembrolizumab plus pemetrexed-platinum as first-line therapy for patients with metastatic non-squamous non-small-cell lung cancer. FUNDING Merck Sharp & Dohme.",2020,"From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014).","['patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189', '126 cancer centres in 16 countries, eligible patients aged 18 years or older with histologically or cytologically confirmed metastatic non-squamous non-small-cell lung cancer without sensitising EGFR or ALK alterations, measurable disease as per Response Evaluation Criteria in Solid Tumors (version 1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled', 'patients with metastatic non-squamous non-small-cell lung cancer', 'Between Feb 26, 2016, and March 6, 2017', 'patients in KEYNOTE-189', '616 patients were enrolled; median follow-up was 10·5 months (range 0·2-20·4) as of data cutoff on Nov 8, 2017']","['pembrolizumab plus pemetrexed-platinum', 'pembrolizumab plus chemotherapy', 'saline placebo', 'pembrolizumab or placebo plus pemetrexed and platinum', 'intravenous pembrolizumab', 'placebo', 'Pembrolizumab plus pemetrexed-platinum', 'intravenous pemetrexed', 'placebo plus pemetrexed-platinum-treated group completed at least one PRO assessment', 'placebo plus chemotherapy', 'placebo plus pemetrexed-platinum', 'cisplatin', 'carboplatin', 'placebo-controlled', 'pembrolizumab']","['Median time to deterioration in cough, chest pain, or dyspnoea', 'QLQ-C30 global health status/quality of life (GHS/QOL) score, and time to deterioration in cough, chest pain, or dyspnoea', 'GHS/QOL scores', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",616.0,0.745602,"From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014).","[{'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: marina.garassino@istitutotumori.mi.it.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Gadgeel', 'Affiliation': 'Department of Medical Oncology 1, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Esteban', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Speranza', 'Affiliation': 'Centre Intégré de Cancérologie de la Montérégie, Hôpital Charles-Le Moyne, Greenfield Park, QC, Canada.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Hospital Universitario Fundación Jiménez Díaz (IIS-FJD), Madrid, Spain.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Vienna, Austria.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Sanford Health, Sioux Falls, SD, USA.'}, {'ForeName': 'Susanna Yee-Shan', 'Initials': 'SY', 'LastName': 'Cheng', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Helge G', 'Initials': 'HG', 'LastName': 'Bischoff', 'Affiliation': 'Thoraxklinik, Heidelberg, Germany.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Peled', 'Affiliation': 'Clalit Health Services, Soroka Medical Center, Beer-Sheeva, Israel.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burke', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30801-0'] 3229,32030734,The impact of fluid optimisation before induction of anaesthesia on hypotension after induction.,"Intra-operative hypotension is a known predictor of adverse events and poor outcomes following major surgery. Hypotension often occurs on induction of anaesthesia, typically attributed to hypovolaemia and the haemodynamic effects of anaesthetic agents. We assessed the efficacy of fluid optimisation for reducing the incidence of hypotension on induction of anaesthesia. This prospective trial enrolled 283 patients undergoing radical cystectomy and randomly allocated them to goal-directed fluid therapy (n = 142) or standard fluid therapy (n = 141). Goal-directed fluid therapy patients received fluid optimisation based on stroke volume response to passive leg raise before induction; those with positive passive leg raise received intravenous crystalloid fluid boluses until stroke volume was optimised. Baseline mean arterial pressure was measured on the morning of surgery and on arriving in the operating theatre. This post-hoc analysis defined haemodynamic instability as either a > 30% relative drop in mean arterial pressure compared with baseline or absolute mean arterial pressure < 55 mmHg, within 15 min of induction. Forty-two (30%) goal-directed fluid therapy patients underwent fluid optimisation after finding an intravascular fluid deficit via passive leg raise testing; 106 (75%) goal-directed fluid therapy and 112 (79%) standard fluid therapy patients met criteria for haemodynamic instability. There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (p = 0.21, p = 0.89, respectively); however, the difference in the incidence of haemodynamic instability was significant using the operating theatre baseline mean arterial pressure (p = 0.004). We conclude that fluid optimisation before induction of general anaesthesia did not significantly impact haemodynamic instability.",2020,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"['283 patients undergoing', 'patients met criteria for haemodynamic instability']","['goal-directed fluid therapy (n\xa0=\xa0142) or standard fluid therapy', 'radical cystectomy', 'standard fluid therapy']","['haemodynamic instability', 'Baseline mean arterial pressure', 'operating theatre baseline mean arterial pressure', 'mean arterial pressure']","[{'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}]",283.0,0.125273,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seier', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}]",Anaesthesia,['10.1111/anae.14984'] 3230,32028458,Exercise Training Rapidly Increases Hepatic Insulin Extraction in NAFLD.,"PURPOSE We aimed to determine the immediacy of exercise intervention on liver-specific metabolic processes in nonalcoholic fatty liver disease. METHODS We undertook a short-term (7-d) exercise training study (60 min·d treadmill walking at 80%-85% of maximal heart rate) in obese adults (N = 13, 58 ± 3 yr, 34.3 ± 1.1 kg·m, >5% hepatic lipid by H-magnetic resonance spectroscopy). Insulin sensitivity index was estimated by oral glucose tolerance test using the Soonthorpun model. Hepatic insulin extraction (HIE) was calculated as the molar difference in area under the curve (AUC) for insulin and C-peptide (HIE = 1 - (AUCInsulin/AUCC-Pep)). RESULTS The increases in HIE, V˙O2max, and insulin sensitivity index after the intervention were 9.8%, 9.8%, and 34%, respectively (all, P < 0.05). Basal fat oxidation increased (pre: 47 ± 6 mg·min vs post: 65 ± 6 mg·min, P < 0.05) and carbohydrate oxidation decreased (pre: 160 ± 20 mg·min vs post: 112 ± 15 mg·min, P < 0.05) with exercise training. After the intervention, HIE correlated positively with adiponectin (r = 0.56, P < 0.05) and negatively with TNF-α (r = -0.78, P < 0.001). CONCLUSIONS By increasing HIE along with peripheral insulin sensitivity, aerobic exercise training rapidly reverses some of the underlying physiological mechanisms associated with nonalcoholic fatty liver disease, in a weight loss-independent manner. This reversal could potentially act through adipokine-related pathways.",2020,"The increase in HIE, VO2max and ISI following the intervention was 9.8%, 9.8% and 34%, respectively (all P<0.05).","['obese adults (N=13, 58±3 years, 34.3±1.1 kg/m, >5% hepatic lipid by H-MR spectroscopy', 'Non-alcoholic fatty liver disease (NAFLD']","['Exercise Training', 'short-term (7-day) exercise training', 'carbohydrate oxidation', 'exercise intervention', 'exercise training', 'aerobic exercise training']","['Basal fat oxidation', 'Hepatic insulin extraction (HIE', 'HIE, VO2max and ISI', 'Insulin sensitivity (ISI', 'Hepatic Insulin Extraction']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.0338532,"The increase in HIE, VO2max and ISI following the intervention was 9.8%, 9.8% and 34%, respectively (all P<0.05).","[{'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Hari', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'CiarÀn E', 'Initials': 'CE', 'LastName': 'Fealy', 'Affiliation': 'Nutrition and Movement Sciences, Maastricht University, Maastricht, The NETHERLANDS.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrated Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Haus', 'Affiliation': 'Human Bioenergetics Laboratory, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Flask', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002273'] 3231,32058364,"Effects of a Multi-ingredient Beverage on Recovery of Contractile Properties, Performance, and Muscle Soreness After Hard Resistance Training Sessions.","Naclerio, F, Larumbe-Zabala, E, Cooper, K, and Seijo, M. Effects of a multi-ingredient beverage on recovery of contractile properties, performance, and muscle soreness after hard resistance training sessions. J Strength Cond Res 34(7): 1884-1893, 2020-Carbohydrate-protein-based supplements have been proposed for maximizing postexercise recovery. This study compared the effects of postworkout supplementation ingesting a multi-ingredient (MTN) vs. carbohydrate alone (CHO) on the recovery of muscle function and perceived of delayed onset of muscle soreness (DOMS) after hard resistance workouts. In a double-blinded, crossover design, 10 resistance trained men (26.9 ± 7.4 years) performed 2 identical 5-day intervention periods while ingesting either MTN or CHO. The subjects performed one workout per day during the first 3 days. Thereafter, they were assessed 1, 24, and 48 hours after the completion of the third workout session. Primary outcome was tensiomyography (muscle displacement [Dm], contraction time [Tc], and contraction velocity [Vc]) of the vastus medialis (VM) and biceps femoris long head (BFLH). Secondary outcomes were performance and DOMS. At 24 hours, both conditions decreased (p < 0.05) Dm (MTN -1.71 ± 1.8, CHO -1.58 ± 1.46 mm) and Vc (MTN -0.03 ± 0.03, CHO 0.03 ± 0.04 m·s) in the VM. At 48 hours, all tensiomyography variables were recovered under the MTN while remained depressed (p < 0.01) in CHO (VM, Dm 1.61 ± 1.60, Vc -0.04 ± 0.04 m·s; BFLH, Dm 1.54 ± 1.52, Vc -0.02 ± 0.02 m·s). Vertical jump performance decreased in CHO, but not in MTN. Although both conditions decreased upper-body strength and power at 1 hour, values returned to baseline in 24 hours for MTM while needed 48 hours in CHO. DOMS similarly increased at both 24 and 48 hours in both conditions. Compared with the ingestion of only carbohydrates, postworkout multi-ingredient supplementation seems to hasten recovery of muscular contractile properties and performance without attenuating DOMS after hard resistance workouts.",2020,"At 24 hours, both conditions decreased (p < 0.05)",['10 resistance trained men (26.9 ± 7.4 years'],"['2020-Carbohydrate-protein-based supplements', 'performed 2 identical 5-day intervention periods while ingesting either MTN or CHO', 'Multi-ingredient Beverage', 'J Strength Cond Res XX(X', 'postworkout supplementation ingesting a multi-ingredient (MTN) vs. carbohydrate alone (CHO']","['tensiomyography (muscle displacement [Dm], contraction time [Tc], and contraction velocity [Vc]) of the vastus medialis (VM) and biceps femoris long head (BFLH', 'performance and DOMS', 'recovery of contractile properties, performance, and muscle soreness', 'Vertical jump performance', 'Recovery of Contractile Properties, Performance, and Muscle Soreness', 'DOMS', 'upper-body strength and power']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",,0.239214,"At 24 hours, both conditions decreased (p < 0.05)","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Naclerio', 'Affiliation': 'Department of Sport Science and Physical Education, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Department of Sport Science and Physical Education, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Seijo', 'Affiliation': 'Department of Sport Science and Physical Education, School of Human Sciences, University of Greenwich, London, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003397'] 3232,31235405,"Effect of a Russian-backbone live-attenuated influenza vaccine with an updated pandemic H1N1 strain on shedding and immunogenicity among children in The Gambia: an open-label, observational, phase 4 study.","BACKGROUND The efficacy and effectiveness of the pandemic H1N1 (pH1N1) component in live attenuated influenza vaccine (LAIV) is poor. The reasons for this paucity are unclear but could be due to impaired replicative fitness of pH1N1 A/California/07/2009-like (Cal09) strains. We assessed whether an updated pH1N1 strain in the Russian-backbone trivalent LAIV resulted in greater shedding and immunogenicity compared with LAIV with Cal09. METHODS We did an open-label, prospective, observational, phase 4 study in Sukuta, a periurban area in The Gambia. We enrolled children aged 24-59 months who were clinically well. Children received one dose of the WHO prequalified Russian-backbone trivalent LAIV containing either A/17/California/2009/38 (Cal09) or A/17/New York/15/5364 (NY15) based on their year of enrolment. Primary outcomes were the percentage of children with LAIV strain shedding at day 2 and day 7, haemagglutinin inhibition seroconversion, and an increase in influenza haemagglutinin-specific IgA and T-cell responses at day 21 after LAIV. This study is nested within a randomised controlled trial investigating LAIV-microbiome interactions (NCT02972957). FINDINGS Between Feb 8, 2017, and April 12, 2017, 118 children were enrolled and received one dose of the Cal09 LAIV from 2016-17. Between Jan 15, 2018, and March 28, 2018, a separate cohort of 135 children were enrolled and received one dose of the NY15 LAIV from 2017-18, of whom 126 children completed the study. Cal09 showed impaired pH1N1 nasopharyngeal shedding (16 of 118 children [14%, 95% CI 8·0-21·1] with shedding at day 2 after administration of LAIV) compared with H3N2 (54 of 118 [46%, 36·6-55·2]; p<0·0001) and influenza B (95 of 118 [81%, 72·2-87·2]; p<0·0001), along with suboptimal serum antibody (seroconversion in six of 118 [5%, 1·9-10·7]) and T-cell responses (CD4+ interferon γ-positive and/or CD4+ interleukin 2-positive responses in 45 of 111 [41%, 31·3-50·3]). After the switch to NY15, a significant increase in pH1N1 shedding was seen (80 of 126 children [63%, 95% CI 54·4-71·9]; p<0·0001 compared with Cal09), along with improvements in seroconversion (24 of 126 [19%, 13·2-26·8]; p=0·011) and influenza-specific CD4+ T-cell responses (73 of 111 [66%, 60·0-75·6; p=0·00028]). The improvement in pH1N1 seroconversion with NY15 was even greater in children who were seronegative at baseline (24 of 64 children [38%, 95% CI 26·7-49·8] vs six of 79 children with Cal09 [8%, 2·8-15·8]; p<0·0001). Persistent shedding to day 7 was independently associated with both seroconversion (odds ratio 12·69, 95% CI 4·1-43·6; p<0·0001) and CD4+ T-cell responses (odds ratio 7·83, 95% CI 2·99-23·5; p<0·0001) by multivariable logistic regression. INTERPRETATION The pH1N1 component switch that took place between 2016 and 2018 might have overcome the poor efficacy and effectiveness reported with previous LAIV formulations. LAIV effectiveness against pH1N1 should, therefore, improve in upcoming influenza seasons. Our data highlight the importance of assessing replicative fitness, in addition to antigenicity, when selecting annual LAIV components. FUNDING The Wellcome Trust.",2019,"Cal09 showed impaired pH1N1 nasopharyngeal shedding (16 of 118 children [14%, 95% CI 8·0-21·1] with shedding at day 2 after administration of LAIV) compared with H3N2 (54 of 118 [46%, 36·6-55·2]; p<0·0001) and influenza B (95 of 118 [81%, 72·2-87·2]; p<0·0001), along with suboptimal serum antibody","['enrolled children aged 24-59 months who were clinically well', 'Between Jan 15, 2018, and March 28, 2018, a separate cohort of 135 children were enrolled and received one dose of the NY15 LAIV from 2017-18, of whom 126 children completed the study', 'children in The Gambia', 'Sukuta, a periurban area in The Gambia', 'Between Feb 8, 2017, and April 12, 2017, 118 children were enrolled and received one dose of the Cal09 LAIV from 2016-17']","['pandemic H1N1 (pH1N1) component', 'WHO prequalified Russian-backbone trivalent LAIV containing either A/17/California/2009/38 (Cal09) or A/17/New York/15/5364 (NY15', 'Russian-backbone live-attenuated influenza vaccine']","['influenza haemagglutinin-specific IgA and T-cell responses', 'T-cell responses (CD4+ interferon γ-positive and/or CD4+ interleukin 2-positive responses', 'seroconversion', 'pH1N1 seroconversion', 'CD4+ T-cell responses', 'pH1N1 shedding', 'pH1N1 nasopharyngeal shedding', 'seroconversion (odds ratio', 'influenza-specific CD4+ T-cell responses', 'percentage of children with LAIV strain shedding at day 2 and day 7, haemagglutinin inhibition seroconversion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016993', 'cui_str': 'Republic of the Gambia'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",118.0,0.217622,"Cal09 showed impaired pH1N1 nasopharyngeal shedding (16 of 118 children [14%, 95% CI 8·0-21·1] with shedding at day 2 after administration of LAIV) compared with H3N2 (54 of 118 [46%, 36·6-55·2]; p<0·0001) and influenza B (95 of 118 [81%, 72·2-87·2]; p<0·0001), along with suboptimal serum antibody","[{'ForeName': 'Benjamin B', 'Initials': 'BB', 'LastName': 'Lindsey', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ya Jankey', 'Initials': 'YJ', 'LastName': 'Jagne', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Armitage', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Singanayagam', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Hadijatou J', 'Initials': 'HJ', 'LastName': 'Sallah', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Sainabou', 'Initials': 'S', 'LastName': 'Drammeh', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Senghore', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Nuredin I', 'Initials': 'NI', 'LastName': 'Mohammed', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jeffries', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Höschler', 'Affiliation': 'Virus Reference Department, Reference Microbiology Services, Public Health England, London, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Tregoning', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Meijer', 'Affiliation': 'Centre for Infectious Disease Research, Diagnostics and Laboratory Surveillance, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Clarke', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': 'Medical Research Council Human Immunology Unit, Weatherall Institute of Molecular Medicine, and Chinese Academy of Medical Science-Oxford Institute, Nuffield Department of Medicine, Oxford University, Oxford, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Barclay', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Kampmann', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; The Vaccine Centre, London School of Hygiene & Tropical Medicine, Faculty of Infectious and Tropical Diseases, London, UK.'}, {'ForeName': 'Thushan I', 'Initials': 'TI', 'LastName': 'de Silva', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; Department of Medicine, Imperial College London, London, UK; The Florey Institute for Host-Pathogen Interactions and Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK. Electronic address: tdesilva@mrc.gm.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30086-4'] 3233,31949042,Scheduled afternoon-evening sleep leads to better night shift performance in older adults.,"OBJECTIVES This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults. METHODS Non-shift workers aged 57.9±4.6 (mean±SD) worked four day (07:00-15:00) and four night shifts (23:00-07:00). Two intervention groups were instructed to remain awake until ~13:00 after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8 hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions. A control group (n=9) from our previous study was not given any sleep instructions. Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance. RESULTS The ST group maintained their day shift sleep durations on night shifts, whereas the control group slept less. The ST group were able to maintain stable performance and alertness across the initial part of the night shift, while the control group's alertness and performance declined across the entire night. Wake duration before a night shift negatively impacted sustained attention and self-reported sleepiness but not reaction time, whereas sleep duration before a night shift affected reaction time and ability to sustain attention but not self-reported sleepiness. CONCLUSIONS A behavioural change under the control of the individual worker, spending 8 hours in bed and waking close to the start of the night shift, allowed participants to acquire more sleep and improved performance on the night shift in older adults. Both sleep duration and timing are important factors for night shift performance and self-reported sleepiness.",2020,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults. ","['Non-shift workers aged 57.9±4.6 (mean±SD) worked four\u2009day (07:00-15:00) and four night shifts (23:00-07:00', 'older adults']","['remain awake until ~13:00\u2009after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8\u2009hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions']","['homeostatic sleep pressure', 'Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance']","[{'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.00963091,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults. ","[{'ForeName': 'Cheryl Martine', 'Initials': 'CM', 'LastName': 'Isherwood', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Chinoy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Audra S', 'Initials': 'AS', 'LastName': 'Murphy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jeanne F', 'Initials': 'JF', 'LastName': 'Duffy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA jduffy@research.bwh.harvard.edu.""}]",Occupational and environmental medicine,['10.1136/oemed-2019-105916'] 3234,32055820,"Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA)-a randomized, controlled crossover trial indicating effects on disease activity.","BACKGROUND Many patients with rheumatoid arthritis (RA) report symptom relief from certain foods. Earlier research indicates positive effects of food and food components on clinical outcomes in RA, but insufficient evidence exists to provide specific dietary advice. Food components may interact but studies evaluating combined effects are lacking. OBJECTIVES We aimed to investigate if an anti-inflammatory diet reduces disease activity in patients with RA. METHODS In this single-blinded crossover trial, 50 patients with RA were randomly assigned to an intervention diet containing a portfolio of suggested anti-inflammatory foods, or a control diet similar to the general dietary intake in Sweden, for 10 wk. After a 4-mo washout period the participants switched diet. Food equivalent to ∼50% of energy requirements was delivered weekly to their homes. For the remaining meals, they were encouraged to consume the same type of foods as the ones provided during each diet. Primary outcome was change in Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR). Secondary outcomes were changes in the components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and DAS28-C-reactive protein. RESULTS In the main analysis, a linear mixed ANCOVA model including the 47 participants completing ≥1 diet period, there was no significant difference in DAS28-ESR between the intervention and control periods (P = 0.116). However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test). No significant differences in the components were observed. CONCLUSIONS This trial indicates positive effects of a proposed anti-inflammatory diet on disease activity in patients with RA. Additional studies are required to determine if this diet can cause clinically relevant improvements.This trial was registered at clinicaltrials.gov as NCT02941055.",2020,"However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test).","['50 patients with RA', 'Rheumatoid Arthritis', 'patients with rheumatoid arthritis (RA', 'patients with RA']","['intervention diet containing a portfolio of suggested anti-inflammatory foods, or a control diet similar to the general dietary intake in Sweden, for 10 wk', 'anti-inflammatory diet', 'Anti-inflammatory Diet']","['DAS28-ESR', 'components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and DAS28-C-reactive protein', 'disease activity', 'change in Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",50.0,0.133574,"However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test).","[{'ForeName': 'Anna K E', 'Initials': 'AKE', 'LastName': 'Vadell', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Bärebring', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hulander', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gjertsson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Winkvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa019'] 3235,31809325,Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Adult Males.,"BACKGROUND Open label placebos with patient education are effective in reducing chronic pain, and recent studies on their effect on pain have established interest in this field. Nevertheless, data on their effect on acute pain are scarce, and on hyperalgesia and allodynia, absent. This study assessed the effect of open label placebos on acute pain in healthy adult males and the influence of placebo education. METHODS Thirty-two healthy males were included in this prospective, randomized, assessor-blinded crossover, single-center study assessing pain intensities (via numeric rating scale), area of hyperalgesia (von Frey filament), and allodynia (dry cotton swab) in a pain model utilizing intracutaneous electrical stimulation. The authors compared the effect of intravenous open label placebo on pain compared to no treatment. The authors further examined the effect of placebo on hyperalgesia and allodynia, and the influence of education (short vs. detailed) before placebo application. Saliva cortisol concentrations were also measured. RESULTS Pain ratings (median, first to third quartile) were 21% lower during placebo treatment compared to no treatment, 4.0 (3.2 to 4.9) versus 5.1 (4.7 to 5.4), respectively (P = 0.001). The areas of hyperalgesia and allodynia were lower during placebo treatment compared to no treatment (hyperalgesia, 30 cm [17 to 47] vs. 55 cm [42 to 68], P = 0.003; allodynia, 24 cm [11 to 39] vs. 45 cm [31 to 62], P = 0.007). This corresponds to reductions of 47%. The extent of placebo education had no effect on pain. Saliva cortisol decreased significantly over time and was under the limit of detectability in the majority of participants in postbaseline measurements in both treatment branches. Baseline cortisol was not associated with the placebo effect or strength applied of current to reach defined pain ratings. CONCLUSIONS Open label placebos might play a role in multimodal analgesic concepts.",2020,"The areas of hyperalgesia and allodynia were lower during placebo treatment compared to no treatment (hyperalgesia, 30 cm [17 to 47] vs. 55 cm [42 to 68], P = 0.003; allodynia, 24 cm [11 to 39] vs. 45 cm [31 to 62], P = 0.007).","['healthy adult males', 'Healthy Adult Males', 'Thirty-two healthy males']","['placebo', 'Open Label Placebo', 'open label placebos', 'intravenous open label placebo']","['pain ratings', 'acute pain', 'Pain Response', 'Saliva cortisol concentrations', 'Saliva cortisol', 'hyperalgesia and allodynia', 'pain', 'pain intensities (via numeric rating scale), area of hyperalgesia (von Frey filament), and allodynia (dry cotton swab', 'Pain ratings']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]",32.0,0.190986,"The areas of hyperalgesia and allodynia were lower during placebo treatment compared to no treatment (hyperalgesia, 30 cm [17 to 47] vs. 55 cm [42 to 68], P = 0.003; allodynia, 24 cm [11 to 39] vs. 45 cm [31 to 62], P = 0.007).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schneider', 'Affiliation': 'From the Department for Anesthesia, Intensive Care Medicine, Prehospital Emergency Medicine and Pain Therapy, University Hospital of Basel, Basel, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Luethi', 'Affiliation': ''}, {'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Mauermann', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bandschapp', 'Affiliation': ''}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Ruppen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003076'] 3236,32044831,Efficacy and Safety of Carbon Dioxide Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients.,"OBJECTIVES Studies have shown the advantages of carbon dioxide (CO2) over air insufflation in the adult population during colonoscopies. This study was designed to investigate the efficacy and safety of CO2 insufflation in deeply sedated children undergoing colonoscopy. METHODS This was a prospective, randomized, double-blind clinical trial. We recruited 100 consecutive pediatric patients who had colonoscopy under deep sedation for various indications. Patients were first randomized by history of abdominal pain and then randomly assigned to either CO2 or air insufflation. Postprocedural abdominal pain scores were registered on a 10-point visual analog rating scale and significant pain was defined as a score of 3 or higher. Abdominal circumferences and end tidal CO2 (ETCO2) levels were measured. Complications during and after the procedure were recorded. RESULTS We did not find statistically significant difference between CO2 and air insufflation on univariate analysis because of low number of children experiencing significant pain after colonoscopy. After adjusting for baseline pain, we found that pain was significantly lower in patients after CO2 versus air insufflation on multivariable analysis (P = 0.03). The significant factors related to pain were duration of the procedure (P = 0.006), history of abdominal pain (P = 0.002) and previous abdominal surgery (P = 0.02). CO2 insufflation was associated with decreased abdominal circumference after colonoscopy (P = 0.002). Girls were more likely to have pain regardless of intervention (P = .04). CONCLUSIONS Most children tolerate endoscopic procedures without significant pain. Our study was underpowered to show significant difference between air and CO2 on univariate analysis. CO2 insufflation during colonoscopy, however, may reduce postprocedural abdominal pain. Significant factors for increased pain on multivariate analysis included colonoscopy length over 30 minutes, history of abdominal pain, and previous abdominal surgery.",2020,We did not find statistically significant difference between CO2 and Air insufflation on univariate analysis due to low number of children experiencing significant pain after colonoscopy.,"['100 consecutive pediatric patients who had colonoscopy under deep sedation for various indications', 'adult population during colonoscopies', 'deeply sedated children undergoing colonoscopy', 'Deeply Sedated Pediatric Patients']","['Carbon Dioxide Versus Air Insufflation', 'CO2 insufflation', 'carbon dioxide (CO2', 'CO2 or air insufflation']","['Post-procedural abdominal pain scores', '10-point visual analog rating scale and significant pain', 'colonoscopy length over 30\u200amin, history of abdominal pain and previous abdominal surgery', 'efficacy and safety', 'history of abdominal pain', 'Efficacy and Safety', 'abdominal circumference', 'previous abdominal surgery', 'pain', 'CO2 insufflation', 'Abdominal circumferences and end tidal CO2 (ETCO2) levels']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4554317', 'cui_str': 'Deeply - dosing instruction fragment (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.310231,We did not find statistically significant difference between CO2 and Air insufflation on univariate analysis due to low number of children experiencing significant pain after colonoscopy.,"[{'ForeName': 'Rajmohan', 'Initials': 'R', 'LastName': 'Dharmaraj', 'Affiliation': 'Division of Gastroenterology, University of New Mexico, Carrie Tingley Hospital, Albuquerque, NM.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dunn', 'Affiliation': ""Division of Department of Gastroenterology, Peyton Manning Children's Hospital, Indianapolis, IN.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Mahua', 'Initials': 'M', 'LastName': 'Dasgupta', 'Affiliation': 'Division of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Simpson', 'Affiliation': 'Division of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cabrera', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Miranda', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Diana G', 'Initials': 'DG', 'LastName': 'Lerner', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002650'] 3237,30892640,"Efficacy of artemether-lumefantrine versus dihydroartemisinin-piperaquine for the treatment of uncomplicated malaria among children in Rwanda: an open-label, randomized controlled trial.","BACKGROUND Artemisinin-based combination therapies (ACTs) have proven highly effective in reducing malaria morbidity in sub-Saharan Africa. Artemether-lumefantrine (AL) was introduced in 2005 as a first-line ACT for the treatment of uncomplicated malaria in Rwanda. Monitoring the therapeutic efficacy of ACTs is necessary to ensure effective malaria case management. METHODS A comparative study on the efficacy of AL and dihydroartemisinin-piperaquine (DHP) was conducted in two sites, Masaka and Ruhuha, between September 2013 and December 2015. Clinical and parasitological responses were assessed at days 28 and 42. RESULTS A total of 534 children were treated with AL (n=267) or DHP (n=267). After polymerase chain reaction (PCR) adjustment, 98.3% and 98.9% of children in the AL and DHP arms, respectively, achieved an adequate clinical and parasitological response (ACPR) at day 28. At day 42, PCR-adjusted ACPR proportions were 97.3% and 98.4% for AL and DHP, respectively. PCR-adjusted ACPR was 99% for both drugs at days 28 and 42 in Ruhuha. The PCR-adjusted ACPR proportions in Masaka were 97.3% for AL and 98.5% for DHP at day 28 and 95.2% for AL and 97.5% for DHP at day 42. CONCLUSIONS AL remains efficacious in Rwanda 10 y after its adoption. The probability of new infections occurring among patients in the DHP arm was significantly lower than those in the AL arm. DHP also demonstrated a greater post-treatment prophylactic effect against new infections compared with AL.",2019,The probability of new infections occurring among patients in the DHP arm was significantly lower than those in the AL arm.,"['two sites, Masaka and Ruhuha, between September 2013 and December 2015', '534 children were treated with AL (n=267) or DHP (n=267', 'uncomplicated malaria among children in Rwanda']","['Artemisinin-based combination therapies (ACTs', 'artemether-lumefantrine versus dihydroartemisinin-piperaquine', 'AL and dihydroartemisinin-piperaquine (DHP']","['malaria morbidity', 'PCR-adjusted ACPR proportions in Masaka', 'PCR-adjusted ACPR', 'adequate clinical and parasitological response (ACPR', 'Clinical and parasitological responses', 'probability of new infections', 'PCR-adjusted ACPR proportions']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0035978', 'cui_str': 'Ruanda'}]","[{'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0936150', 'cui_str': 'artemether / lumefantrine'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439633', 'cui_str': 'New infection (qualifier value)'}]",534.0,0.109395,The probability of new infections occurring among patients in the DHP arm was significantly lower than those in the AL arm.,"[{'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Uwimana', 'Affiliation': 'Malaria and Other Parasitic Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Penkunas', 'Affiliation': 'Demand-Driven Evaluations for Decisions, Clinton Health Access Initiative, Kigali, Rwanda.'}, {'ForeName': 'Marie Paul', 'Initials': 'MP', 'LastName': 'Nisingizwe', 'Affiliation': 'Demand-Driven Evaluations for Decisions, Clinton Health Access Initiative, Kigali, Rwanda.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Warsame', 'Affiliation': 'Global Malaria Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Noella', 'Initials': 'N', 'LastName': 'Umulisa', 'Affiliation': 'Maternal and Child Survival Program, United States Agency for International Development, Kigali, Rwanda.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Uyizeye', 'Affiliation': 'Maternal and Child Survival Program, United States Agency for International Development, Kigali, Rwanda.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Musanabaganwa', 'Affiliation': 'Medical Research Center, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Tharcisse', 'Initials': 'T', 'LastName': 'Munyaneza', 'Affiliation': 'National Reference Laboratory, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Ntagwabira', 'Affiliation': 'National Reference Laboratory, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Dieudonne', 'Initials': 'D', 'LastName': 'Hakizimana', 'Affiliation': 'Demand-Driven Evaluations for Decisions, Clinton Health Access Initiative, Kigali, Rwanda.'}, {'ForeName': 'Claude Mambo', 'Initials': 'CM', 'LastName': 'Muvunyi', 'Affiliation': 'Laboratory Unit, University Teaching Hospital of Kigali, Rwanda.'}, {'ForeName': 'Claver', 'Initials': 'C', 'LastName': 'Kayobotsi', 'Affiliation': 'Single Project Implementation Unit, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Michee', 'Initials': 'M', 'LastName': 'Kabera', 'Affiliation': 'Malaria and Other Parasitic Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Murindahabi', 'Affiliation': 'Malaria and Other Parasitic Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Aimable', 'Initials': 'A', 'LastName': 'Mbituyumuremyi', 'Affiliation': 'Malaria and Other Parasitic Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/trz009'] 3238,32030508,"Abrogation of postprandial triglyceridemia with dual PPAR α/γ agonist in type 2 diabetes mellitus: a randomized, placebo-controlled study.","AIMS Lowering postprandial lipemia may mitigate cardiovascular risk in patients with diabetic dyslipidemia. This study was aimed to investigate whether saroglitazar suppresses postprandial lipemia in patients with diabetes and dyslipidemia. METHODS This was a 12-week, prospective, multicenter, randomized, double-blinded, placebo-controlled study of saroglitazar in patients with diabetes and dyslipidemia. Thirty patients were randomized (1:1) to receive saroglitazar 4 mg or placebo orally once daily with metformin for 12 weeks. The primary endpoint was change in plasma triglyceride (TG) area under the curve (AUC) on a standardized 8-h fat tolerance test. RESULTS Thirty participants were randomized for interventions and eventually data of 19 participants qualified for per protocol analyses. Mean (SD) age in saroglitazar was 53.1 (8.8) years and 54.9 (7.7) years in placebo group. After 12 weeks, saroglitazar significantly lowered postprandial TG-AUC by - 458.3 (144.0) (- 25.7%, 95% CI - 765.1 to - 151.4) versus an increase of + 10.9 (157.9) (+ 0.5%, 95% CI - 325.6 to 347.3) mg/dL h in placebo group (P < 0.05). Saroglitazar lowered postprandial TG incremental AUC versus placebo: - 329.4 (89.9) (- 59%) versus + 80.4 (99.4) (+ 10%) mg/dL h (P < 0.05). HbA1c (%) decreased by - 0.36 (0.42) in the saroglitazar group as compared to an increase of + 1.26 (0.46) (P < 0.05) with placebo. CONCLUSIONS The saroglitazar treatment significantly improved postprandial TGs in people with diabetic dyslipidemia. TRIAL REGISTRATION Clinical Trial Registry of India; trial Registration No.: CTRI/2015/06/005845 and Date of registration: June 02, 2015.",2020,"HbA1c (%) decreased by - 0.36 (0.42) in the saroglitazar group as compared to an increase of + 1.26 (0.46) (P < 0.05) with placebo. ","['patients with diabetic dyslipidemia', 'people with diabetic dyslipidemia', 'patients with diabetes and dyslipidemia', 'type 2 diabetes mellitus', 'Thirty participants', 'Thirty patients']","['postprandial triglyceridemia with dual PPAR α/γ agonist', 'saroglitazar 4\xa0mg or placebo orally once daily with metformin', 'placebo', 'saroglitazar']","['postprandial TG-AUC', 'postprandial TGs', 'Mean (SD) age in saroglitazar', 'change in plasma triglyceride (TG) area under the curve (AUC) on a standardized 8-h fat tolerance test', 'postprandial TG incremental AUC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160761', 'cui_str': 'Diabetic dyslipidaemia'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3852920'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3852920'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0430156', 'cui_str': 'Fat tolerance test (procedure)'}]",30.0,0.749475,"HbA1c (%) decreased by - 0.36 (0.42) in the saroglitazar group as compared to an increase of + 1.26 (0.46) (P < 0.05) with placebo. ","[{'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Dunbar', 'Affiliation': 'Cardiometabolic and Lipid Clinic, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Hemant P', 'Initials': 'HP', 'LastName': 'Thacker', 'Affiliation': 'Bhatia Hospital, G-1 Block, Tardeo Road, Mumbai, Maharashtra, 400007, India.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Bhatt', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, Gujarat, 382210, India.'}, {'ForeName': 'Krupi', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, Gujarat, 382210, India.'}, {'ForeName': 'Deven V', 'Initials': 'DV', 'LastName': 'Parmar', 'Affiliation': 'Clinical R&D, Cadila Healthcare Limited, Ahmedabad, Gujarat, 382210, India. deven.parmar@zydusdiscovery.ae.'}]",Acta diabetologica,['10.1007/s00592-020-01487-8'] 3239,31562765,The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot Randomized Controlled Trial.,"INTRODUCTION This trial investigated whether a Facebook smoking cessation intervention culturally tailored to young sexual and gender minority (SGM) smokers (versus non-tailored) would increase smoking abstinence. METHODS Participants were 165 SGM young adult U.S. smokers (age 18-25) recruited from Facebook in April 2018 and randomized to an SGM-tailored (POP; N=84) or non-tailored (TSP-SGM; N=81) intervention. Interventions delivered weekly live counseling sessions and 90 daily Facebook posts to participants in Facebook groups. Primary analyses compared POP and TSP-SGM on biochemically verified smoking abstinence (yes/no; primary outcome), self-reported 7-day point prevalence abstinence (yes/no), reduction in cigarettes per week by 50+% from baseline (yes/no), making a quit attempt during treatment (yes/no), and stage of change (precontemplation/contemplation vs. preparation/action). Supplemental analyses compared POP to two historical control groups. RESULTS POP participants were more likely than TSP-SGM participants to report smoking abstinence at 3 (23.8% vs. 12.3%; OR=2.50; p=.03) and 6 months (34.5% vs. 12.3%; OR=4.06; p<.001) and reduction in smoking at 3 months (52.4% vs. 39.5%; OR=2.11; p=.03). Biochemically verified smoking abstinence did not significantly differ between POP and TSP-SGM at 3 (OR=2.00; p=.33) or 6 months (OR=3.12; p=.08), potentially due to challenges with remote biochemical verification. In supplemental analyses, POP participants were more likely to report abstinence at 3 (OR=6.82, p=.01) and 6 (OR=2.75, p=.03) months and reduced smoking at 3 months (OR=2.72, p=.01) than participants who received a referral to Smokefree.gov. CONCLUSIONS This pilot study provides preliminary support for the effectiveness of a Facebook smoking cessation intervention tailored to SGM young adults. IMPLICATIONS Sexual and gender minority (SGM) individuals have disproportionately high smoking prevalence. It is unclear whether smoking cessation interventions culturally tailored to the SGM community are more effective than non-tailored interventions. This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.",2019,"This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.","['SGM young adults', 'Participants were 165 SGM young adult U.S. smokers (age 18-25) recruited from Facebook in April 2018 and randomized to an', 'Young Sexual and Gender Minority Smokers', 'Sexual and gender minority (SGM) individuals have disproportionately high smoking prevalence', 'young sexual and gender minority (SGM) smokers (versus non-tailored']","['live counseling sessions', 'Facebook smoking cessation intervention', 'SGM-tailored (POP; N=84) or non-tailored (TSP-SGM; N=81) intervention', 'SGM-tailored Facebook smoking cessation intervention', 'Facebook Intervention']","['self-reported 7-day point prevalence abstinence', 'POP and TSP-SGM on biochemically verified smoking abstinence', 'report abstinence', 'smoking abstinence']","[{'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0275547,"This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Humfleet', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz184'] 3240,31837232,Twenty-four-hour subjective and pharmacological effects of ad-libitum electronic and combustible cigarette use among dual users.,"BACKGROUND AND AIMS Relative pharmacological effects of e-cigarettes and cigarettes during 24 hours of ad-libitum use have not been described. In this study, 24-hour blood plasma nicotine concentrations and 48-hour subjective effects with use of cigarettes and e-cigarettes were measured among dual users. DESIGN Two-arm within-subject cross-over design with preferred e-cigarette or cigarette ad-libitum use over 48 hours. SETTING Hospital research ward in San Francisco, California, USA. PARTICIPANTS Thirty-six healthy dual users of e-cigarettes and cigarettes (n = 8, 25% females). MEASUREMENTS Twenty-four-hour blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects. FINDINGS Analyses used analysis of variance (ANOVA)-based mixed models with order of product (e-cigarette or cigarette) and product type (combustible cigarette or type of e-cigarette) as fixed effects, and subject as a repeated effect. During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence. Compared to cigarette smoking, nicotine exposure for variable-power tank users was similar, while cig-a-like (t (30)  = 2.71, P = 0.011, d = 0.745) and fixed-power tank users (t (30)  = 3.37, P = 0.002, d = 0.993) were exposed to less nicotine. Cigarettes were rated higher than e-cigarettes on some desirable subjective effects (e.g. psychological reward, t (322)  = 7.24 P < 0.001, d = 0.432), but withdrawal symptom reduction was comparable. No differences were found between e-cigarette types, but Bayes factors indicate that these measures were insensitive. CONCLUSIONS During a 24-hour period in a hospital setting in the United States, nicotine exposure for dual users of e-cigarettes and cigarettes was similar when using cigarettes or variable-power tank devices only but was lower for those using cig-a-like or fixed-power devices only. Despite lower nicotine levels, all types of e-cigarette were effective in preventing withdrawal symptoms. E-cigarettes were rated less rewarding than cigarettes.",2020,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","['Thirty-six healthy dual users of e-cigarettes and cigarettes (n\xa0', 'Hospital research ward in San Francisco, California, USA']",[],"['withdrawal symptoms', '24-hour blood plasma nicotine concentrations', 'blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects', 'withdrawal symptom reduction']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035168'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",36.0,0.0290211,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","[{'ForeName': 'Arit M', 'Initials': 'AM', 'LastName': 'Harvanko', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Addo', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14931'] 3241,25858497,"A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer.","BACKGROUND Masitinib is a selective oral tyrosine-kinase inhibitor. The efficacy and safety of masitinib combined with gemcitabine was compared against single-agent gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDAC). PATIENTS AND METHODS Patients with inoperable, chemotherapy-naïve, PDAC were randomized (1 : 1) to receive gemcitabine (1000 mg/m(2)) in combination with either masitinib (9 mg/kg/day) or a placebo. The primary endpoint was overall survival (OS) in the modified intent-to-treat population. Secondary OS analyses aimed to characterize subgroups with poor survival while receiving single-agent gemcitabine with subsequent evaluation of masitinib therapeutic benefit. These prospectively declared subgroups were based on pharmacogenomic data or a baseline characteristic. RESULTS Three hundred and fifty-three patients were randomly assigned to receive either masitinib plus gemcitabine (N = 175) or placebo plus gemcitabine (N = 178). Median OS was similar between treatment-arms for the overall population, at respectively, 7.7 and 7.1 months, with a hazard ratio (HR) of 0.89 (95% CI [0.70; 1.13]. Secondary analyses identified two subgroups having a significantly poor survival rate when receiving single-agent gemcitabine; one defined by an overexpression of acyl-CoA oxidase-1 (ACOX1) in blood, and another via a baseline pain intensity threshold (VAS > 20 mm). These subgroups represent a critical unmet medical need as evidenced from median OS of 5.5 months in patients receiving single-agent gemcitabine, and comprise an estimated 63% of patients. A significant treatment effect was observed in these subgroups for masitinib with median OS of 11.7 months in the 'ACOX1' subgroup [HR = 0.23 (0.10; 0.51), P = 0.001], and 8.0 months in the 'pain' subgroup [HR = 0.62 (0.43; 0.89), P = 0.012]. Despite an increased toxicity of the combination as compared with single-agent gemcitabine, side-effects remained manageable. CONCLUSIONS The present data warrant initiation of a confirmatory study that may support the use of masitinib plus gemcitabine for treatment of PDAC patients with overexpression of ACOX1 or baseline pain (VAS > 20mm). Masitinib's effect in these subgroups is also supported by biological plausibility and evidence of internal clinical validation. TRIAL REGISTRATION ClinicalTrials.gov:NCT00789633.",2015,"Median OS was similar between treatment-arms for the overall population, at respectively, 7.7 and 7.1 months, with a hazard ratio (HR) of 0.89 (95% CI [0.70; 1.13].","['PDAC patients with overexpression of ACOX1 or baseline pain (VAS > 20mm', 'Patients with inoperable, chemotherapy-naïve, PDAC', 'advanced pancreatic cancer', 'Three hundred and fifty-three patients', 'patients with advanced pancreatic ductal adenocarcinoma (PDAC']","['masitinib combined with gemcitabine', 'gemcitabine', 'placebo', 'gemcitabine (1000 mg/m(2)) in combination with either masitinib', 'placebo plus gemcitabine', 'masitinib plus gemcitabine']","['toxicity', 'efficacy and safety', 'survival rate', 'overall survival (OS', 'Median OS', 'overexpression of acyl-CoA oxidase-1 (ACOX1) in blood, and another via a baseline pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C2351398', 'cui_str': '4-((4-methylpiperazin-1-yl)methyl)-N-(4-methyl-3-((4-(pyridin-3-yl)-1,3-thiazol-2-yl)amino)phenyl)benzamide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0050690', 'cui_str': 'Fatty Acyl-Coenzyme A Oxidase'}, {'cui': 'C0005768'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",353.0,0.137316,"Median OS was similar between treatment-arms for the overall population, at respectively, 7.7 and 7.1 months, with a hazard ratio (HR) of 0.89 (95% CI [0.70; 1.13].","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': 'Department of Medical Oncology, Saint Joseph Hospital, Paris. Electronic address: gdeplanque@hpsj.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Demarchi', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon, Besançon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hebbar', 'Affiliation': 'Department of Medical Oncology, University Hospital, Lille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Flynn', 'Affiliation': 'Metro-Minnesota Community Clinical Oncology Program, Park Nicollet Institute, Minneapolis, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacký University Medical School & Teaching Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': 'Southeastern Medical Oncology Center, Goldsboro, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nowara', 'Affiliation': 'Department of Clinical and Experimental Oncology, Maria Skłodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Poland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moyé', 'Affiliation': 'Department of Biostatistics, University of Texas School of Public Health, Houston, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Piquemal', 'Affiliation': 'Clinical Development, Acobiom, Montpellier.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ritter', 'Affiliation': 'Clinical Development, Acobiom, Montpellier.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dubreuil', 'Affiliation': 'Signaling, Hematopoiesis and Mechanism of Oncogenesis, Inserm U1068, CRCM, Marseille; Institut Paoli-Calmettes, Marseille; Aix-Marseille University, UM 105, Marseille; CNRS, UMR7258, CRCM, Marseille; Clinical Development, AB Science, Paris.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Mansfield', 'Affiliation': 'Clinical Development, AB Science, Paris.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Acin', 'Affiliation': 'Clinical Development, AB Science, Paris.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moussy', 'Affiliation': 'Clinical Development, AB Science, Paris.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Clinical Development, AB Science, Paris; Department of Clinical Hematology, Necker Hospital, Paris; INSERM UMR 1163, Laboratory of Cellular and Molecular Mechanisms of Hematological Disorders and Therapeutic Implications, Paris; Paris Descartes - Sorbonne Paris Cité University, Imagine Institute, Paris; CNRS ERL 8254, Paris; Laboratory of Excellence GR-Ex, Paris; National Reference Center on Mastocytosis (CEREMAST), Paris.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Department of Gastroenterology, Hôpital Beaujon, Clichy, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv133'] 3242,25712456,Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest.,"BACKGROUND Early tumor shrinkage (ETS) and depth of response (DoR) predict overall survival (OS) in first-line trials of chemotherapy ± anti-EGFR monoclonal antibodies in metastatic colorectal cancer (mCRC). These associations and the predictive accuracy of response measurements for survival parameters were investigated in the phase III TRIBE trial of FOLFOXIRI plus bevacizumab (bev) versus FOLFIRI plus bev. PATIENTS AND METHODS A landmark approach was adopted to define the assessable population. The distribution of RECIST response rate, ETS and DoR was compared in the two arms. Associations between response measurements and progression-free survival (PFS), post-progression survival (PPS) and OS were tested by univariate and multivariate Cox models. Prediction performance of each factor was estimated by C-index. RESULTS A significantly higher percentage of patients in the FOLFOXIRI plus bev arm achieved ETS ≥20%, when compared with the control arm (62.7% versus 51.9%, P = 0.025). Also the DoR was significantly higher in the triplet plus bev arm (43.4% versus 37.8%, P = 0.003). Both ETS and DoR were associated with PFS, PPS and OS at the univariate analyses and in the multivariate models stratified for other prognostic variables. Both ETS and DoR were able to predict survival as accurately as RECIST response. CONCLUSION FOLFOXIRI plus bev improves ETS and DoR when compared with FOLFIRI plus bev. Achieving rapid and deep tumor shrinkage consistently delays tumor progression and prolongs survival in patients treated with first-line chemotherapy plus bev. ETS is a promising and valuable end point for clinical trials' design deserving further investigation.",2015,"Both ETS and DoR were associated with PFS, PPS and OS at the univariate analyses and in the multivariate models stratified for other prognostic variables.","['metastatic colorectal cancer patients treated with', 'metastatic colorectal cancer (mCRC']","['first-line chemotherapy plus bevacizumab', 'bevacizumab', 'ETS']","['distribution of RECIST response rate, ETS and DoR', 'DoR', 'survival', 'progression-free survival (PFS), post-progression survival (PPS) and OS', 'ETS and DoR']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0772141,"Both ETS and DoR were associated with PFS, PPS and OS at the univariate analyses and in the multivariate models stratified for other prognostic variables.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Unit of Medical Oncology 1, Istituto Oncologico Veneto, IRCSS, Padova.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Salvatore', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cortesi', 'Affiliation': 'Department of Medical Oncology, University of Rome La Sapienza, Rome.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Division of Medicine and Medical Oncology, Azienda Istituti Ospitalieri, Cremona.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Spadi', 'Affiliation': 'Azienda Ospedaliero-Universitaria Città Della Salute e Della Scienza, Turin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Department of Medical Oncology, Fondazione Poliambulanza, Brescia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tonini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Unit of Medical Oncology, Università Cattolica del Sacro Cuore, Rome.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vitello', 'Affiliation': ""Unit of Oncology, Sant'Elia Hospital, Caltanissetta.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Longarini', 'Affiliation': 'Unit of Medical Oncology, San Gerardo Hospital, Monza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bonetti', 'Affiliation': 'Unit of Medical Oncology, Mater Salutis Hospital, Legnago.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': 'Unit of Medical Oncology, Galliera Hospital, Genoa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Di Donato', 'Affiliation': 'Department of Medical Oncology Sandro Pitigliani, Prato Hospital, Istituto Toscano Tumori, Prato.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Granetto', 'Affiliation': 'Unit of Medical Oncology, Azienda Sanitaria Ospedaliera Santa Croce e Carle, Cuneo.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Coordinating Center, Istituto Toscano Tumori, Firenze.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa. Electronic address: alfredo.falcone@med.unipi.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv112'] 3243,25739671,Postoperative irinotecan in resected stage II-III rectal cancer: final analysis of the French R98 Intergroup trial†.,"BACKGROUD The R98 trial explores the addition of irinotecan to a 5-fluorouracil (5-FU) plus leucovorin (5-FU/LV) adjuvant regimen in optimally resected stages II-III rectal cancers. We report the updated long-term results. Disease-free survival (DFS) was the primary end point. PATIENST AND METHODS Between March 1999 and December 2005, 357 patients were randomized: 178 in 5-FU/LV and 179 in LV5-FU2 + irinotecan arm. The trial was stratified by control arm: Mayo Clinic regimen or LV5-FU2 regimen. RESULTS Three hundred and fifty-seven randomized patients were evaluable for efficacy. With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154]. The same was observed for overall survival (OS) (HR = 0.87, P = 0.433). The 5-year DFS was 58% in the control arm and 63% in the experimental arm. The 5-year OS was 74% in the control arm and 75% in the experimental arm. Patients allocated to the experimental arm had more grade 3-4 neutropenia when compared with the LV5-FU2 arm (33% versus 6%, P = 0.03), but not when compared with the Mayo Clinic arm (33% versus 36%, P = 0.84). Grade 3-4 diarrhoea tended to be higher in the experimental arm, but analyses stratified by control arm or by radiotherapy failed to show significant differences across strata (test for interaction P = 0.44). CONCLUSION Even though a benefit of irinotecan in subgroups of patients cannot be excluded, due to early termination and lack of power, the study does not support the addition of irinotecan to 5-FU/LV in routine in patients with resected stage II-III rectal cancer.",2015,"With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154].","['357 patients were randomized: 178 in', 'resected stage II-III rectal cancer', 'optimally resected stages II-III rectal cancers', 'Between March 1999 and December 2005', 'patients with resected stage II-III rectal cancer']","['Postoperative irinotecan', '5-FU/LV and 179 in LV5-FU2 + irinotecan arm', '5-fluorouracil (5-FU) plus leucovorin (5-FU/LV) adjuvant regimen', '5-FU/LV', 'irinotecan', 'LV5-FU2']","['grade 3-4 neutropenia', 'overall survival (OS', '5-year OS', 'Grade 3-4 diarrhoea', '5-year DFS', 'Disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",357.0,0.0941184,"With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154].","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Delbaldo', 'Affiliation': 'Oncology Unit, Diaconesses Croix Saint Simon Hospital, Paris. Electronic address: cdelbaldo@hopital-dcss.org.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ychou', 'Affiliation': ""Digestive Oncology Unit, ICM Val D'Aurelle, Montpellier.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zawadi', 'Affiliation': 'Radiotherapy Unit, Departemental Hospital Center, La Roche Sur Yon.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Douillard', 'Affiliation': 'Oncology Unit, René Gauducheau Center, St-Herblain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Oncology Unit, Saint-Antoine Hospital, GERCOR, and UMPC University Paris VI, Paris.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Guerin-Meyer', 'Affiliation': 'Oncology Unit, Paul Papin Center, Angers.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rougier', 'Affiliation': 'Hepatogastroenterology and Digestive Oncology Unit, Université Paris V, Europeen Georges Pompidou Hospital, Paris.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dupuis', 'Affiliation': 'Radiotherapy Unit, Jean-Bernard Center, Le Mans.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Digestive Unit, Departemental Hospital Center, La Roche sur Yon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jouhaud', 'Affiliation': 'Radiotherapy Unit, Henri Mondor Hospital, Créteil, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quinaux', 'Affiliation': 'International Development Drug Institute (IDDI), Louvain-la-Neuve, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'International Development Drug Institute (IDDI), Louvain-la-Neuve, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Piedbois', 'Affiliation': 'Oncology Unit, Paul Strauss Center, Strasbourg, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv135'] 3244,32037283,Brain activation and subjective anxiety during an anticipatory anxiety task is related to clinical outcome during prazosin treatment for alcohol use disorder.,"BACKGROUND Higher levels of anxiety, negative affect, and impaired emotion regulation are associated with alcohol use disorder (AUD) and contribute to relapse and worse treatment outcomes. Prazosin, while typically used to treat post-traumatic stress disorder (PTSD) and other anxiety disorders, has shown promise for treating AUD. In order to better understand these underlying neural processes in individuals with AUD, our aims in this study were to measure brain activation during an anticipatory anxiety task before treatment to determine whether observed patterns supported previous work. We then aimed to measure the effects of prazosin on patients with AUD and explore whether greater baseline anticipatory anxiety (as measured by subjective and neural measures) predicts better treatment outcomes. METHODS Thirty-four individuals seeking treatment for AUD participated in a six-week placebo-controlled study of prazosin and underwent an anticipatory anxiety task during fMRI scans at baseline and three weeks. Alcohol use over six weeks was measured. RESULTS Greater levels of subjective anxiety and deactivation in posterior cingulate cortex (PCC) and ventromedial prefrontal cortex (vmPFC) were observed during high-threat stimuli compared to low-threat stimuli. Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task. However, AUD patients with greater vmPFC deactivation during high threat relative to low threat and patients with low baseline anticipatory anxiety during the task had worse clinical outcomes on prazosin. CONCLUSIONS Deactivation in PCC and vmPFC to high-threat stimuli replicated previous work and shows promise for further study as a marker for AUD. Although prazosin did not affect brain activation in the regions of interest during the anticipatory anxiety task, subjective levels of anxiety and brain activation in vmPFC predicted treatment outcomes in individuals with AUD undergoing treatment with prazosin, highlighting individuals more likely to benefit from prazosin than others.",2020,"Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task.","['individuals with AUD undergoing treatment with', 'individuals with AUD', 'Thirty-four individuals seeking treatment for AUD participated in a six-week', 'patients with AUD']","['prazosin and underwent an anticipatory anxiety task', 'placebo, prazosin', 'Prazosin', 'placebo', 'prazosin']","['baseline anticipatory anxiety', 'subjective anxiety', 'Brain activation and subjective anxiety', 'anticipatory anxiety task, subjective levels of anxiety and brain activation', 'brain activation', 'subjective anxiety and deactivation in posterior cingulate cortex (PCC) and ventromedial prefrontal cortex (vmPFC']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}]",34.0,0.0217835,"Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task.","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wilcox', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA. Electronic address: cwilcox@mrn.org.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390, USA; VA North Texas Health Care System, 4500 S Lancaster Rd, Dallas, TX 75216, USA; Department of Psychiatry, School of Medicine, University of Colorado, 13001 E 17th Place, Aurora, CO 80045, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Clifford', 'Affiliation': 'Department of Psychiatry, University of New Mexico, 2400 Tucker NE, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, Center on Alcoholism, Substance Abuse & Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Mayer', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Kylar M', 'Initials': 'KM', 'LastName': 'Boggs', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eck', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA; University of Southern California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bogenschutz', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102162'] 3245,32015461,"Double blind, two dose, randomized, placebo-controlled, cross-over clinical trial of the positive allosteric modulator at the alpha7 nicotinic cholinergic receptor AVL-3288 in schizophrenia patients.","Despite their theoretical rationale, nicotinic alpha-7 acetylcholine (nα 7 ) receptor agonists, have largely failed to demonstrate efficacy in placebo-controlled trials in schizophrenia. AVL-3288 is a nα 7 positive allosteric modulator (PAM), which is only active in the presence of the endogenous ligand (acetylcholine), and thus theoretically less likely to cause receptor desensitization. We evaluated the efficacy of AVL-3288 in a Phase 1b, randomized, double-blind, placebo-controlled, triple cross-over study. Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) ≥62 were randomized. Each subject received 5 days of AVL-3288 (10, 30 mg) and placebo across three separate treatment weeks. The primary outcome measure was the RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker. Secondary outcome measures include task-based fMRI (RISE task), mismatch negativity, the Scale for the Assessment of Negative Symptoms of Schizophrenia (SANS) and the Brief Psychiatric Rating Scale (BPRS). Twenty-four subjects were randomized and treated without any clinically significant treatment emergent adverse effects. Baseline RBANS (82 ± 17) and BPRS (41 ± 13) scores were consistent with moderate impairment. Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS. In conclusion, the results did not indicate efficacy of the compound, consistent with most prior results for the nα 7 target.",2020,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","['schizophrenia patients', 'Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a repeatable battery for the assessment of neuropsychological status (RBANS) ≥62 were randomized']","['placebo', 'AVL-3288']","['task-based fMRI (RISE task), mismatch negativity, the scale for the assessment of negative symptoms of schizophrenia (SANS) and the brief psychiatric rating scale (BPRS', 'RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449216', 'cui_str': 'aVL (body structure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3850132', 'cui_str': 'P50 Wave'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",24.0,0.429793,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, USA. jk3380@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freedman', 'Affiliation': 'U Colorado, Denver, CO, USA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Vail', 'Affiliation': 'New York State Psychiatric Institute, New York, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0628-9'] 3246,25722382,Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses.,"BACKGROUND Tecemotide is a MUC1-antigen-specific cancer immunotherapy. The phase III START study did not meet its primary end point but reported notable survival benefit with tecemotide versus placebo in an exploratory analysis of the predefined patient subgroup treated with concurrent chemoradiotherapy. Here, we attempted to gain further insight into the effects of tecemotide in START. PATIENTS AND METHODS START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer. We present updated overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type. RESULTS Updated OS data are consistent with the primary analysis: median 25.8 months (tecemotide) versus 22.4 months (placebo) (HR 0.89, 95% CI 0.77-1.03, P = 0.111), with ∼20 months additional median follow-up time compared with the primary analysis. Exploratory analysis of the predefined subgroup treated with concurrent chemoradiotherapy revealed clinically relevant prolonged OS with tecemotide versus placebo (29.4 versus 20.8 months; HR 0.81, 95% CI 0.68-0.98, P = 0.026). No improvement was seen with sequential chemoradiotherapy. High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers. Interactions between lymphocyte count, NLR, or prespecified HLA alleles and treatment effect were not observed. CONCLUSION Updated OS data support potential treatment benefit with tecemotide in patients treated with concurrent chemoradiotherapy. Exploratory biomarker analyses suggest that elevated sMUC1 or ANA levels correlate with tecemotide benefit. CLINICALTRIALSGOV NUMBER NCT00409188.",2015,High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers.,"['START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer', 'patients treated with concurrent chemoradiotherapy']","['concurrent chemoradiotherapy', 'placebo']","['lymphocyte count, NLR, or prespecified HLA alleles and treatment effect', 'notable survival benefit', 'overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type']","[{'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0587178', 'cui_str': 'ANA measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",,0.388161,High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Olivia Newton-John Cancer and Wellness Centre, Austin Hospital, Melbourne, Australia. Electronic address: paul.mitchell@austin.org.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Thatcher', 'Affiliation': 'Christie Hospital NHS Trust, Manchester, UK.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'UPMC Cancer Pavilion, Pittsburgh, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wasilewska-Tesluk', 'Affiliation': 'University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Horwood', 'Affiliation': 'Princess Alexandra Hospital, Woolloongabba, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Mazowieckie Centrum Leczenia Chorób Pluc i Gruzlicy, Otwock, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Martín', 'Affiliation': 'Division of Clinical Oncology, Instituto Especializado Alexander Fleming, Buenos Aires, Argentina.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ragulin', 'Affiliation': 'Medical Radiological Research Center, Obninsk, Russia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zukin', 'Affiliation': 'Clinical Oncology, Instituto Nacional do Câncer-INCA, Rio de Janeiro, Brazil.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Helwig', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Falk', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Cancer Care, Cross Cancer Institute, Edmonton.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, Toronto, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv104'] 3247,25735317,Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: final results for first-line treatment from the ITACa randomized clinical trial.,"BACKGROUND We report the results from a first-line phase III randomized clinical trial on metastatic colorectal cancer (mCRC) aimed at evaluating the effectiveness of adding bevacizumab (B) to standard first-line chemotherapy (CT). PATIENTS AND METHODS mCRC patients were randomized to receive first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT only (arm B). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate (ORR) and safety. Three hundred and fifty patients and 310 events were required to have an 80% statistical power to detect a difference in PFS between the groups. RESULTS Between November 2007 and March 2012, 376 patients were randomized. About 60% of patients received FOLFOX4 and 40% FOLFIRI. After a median follow-up of 36 months, 343 progressions and 275 deaths had been observed in the overall population. The median PFS was 9.6 [95% confidence interval (CI) 8.2-10.3] and 8.4 (95% CI 7.2-9.0) months for arms A and B, respectively, with a hazard ratio of 0.86 (95% CI 0.70-1.07; P = 0.182). No statistically significant differences in OS or ORR were observed. B-containing regimens were associated with more frequent hypertension, bleeding, proteinuria and asthenia. CONCLUSIONS The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR. Further research is warranted to better identify the target population. CLINICAL TRIAL NUMBER NCT01878422.",2015,"The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR.","['mCRC patients', 'metastatic colorectal cancer (mCRC', 'Between November 2007 and March 2012, 376 patients were randomized', 'metastatic colorectal cancer']","['standard chemotherapy', 'bevacizumab', 'first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT', 'bevacizumab (B) to standard first-line chemotherapy (CT']","['median PFS', 'OS or ORR', 'PFS', 'overall survival (OS), response rate (ORR) and safety', 'frequent hypertension, bleeding, proteinuria and asthenia', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",376.0,0.253185,"The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori. Electronic address: alessandro.passardi@irst.emr.it.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Nanni', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tassinari', 'Affiliation': 'Department of Oncology, Per gli Infermi Hospital, Rimini.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Turci', 'Affiliation': 'Oncology Unit, S. Maria delle Croci Hospital, Ravenna.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Medical Oncology Unit, Guglielmo da Saliceto Hospital, Piacenza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fontana', 'Affiliation': 'Oncology Unit, University Hospital of Modena and Reggio Emilia, Modena.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ruscelli', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mucciarini', 'Affiliation': 'Medical Oncology Unit, Ramazzini Hospital, Carpi.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology Unit, Vito Fazzi Hospital, Lecce; Department of Medical Oncology, Istituto Tumori, Bari, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ragazzini', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Frassineti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Amadori', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv130'] 3248,32024486,Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol.,"BACKGROUND Persistent post-concussive symptoms (PPCS) affect up to 30% of individuals following mild traumatic brain injury. PPCS frequently includes exercise intolerance. Sub-symptom threshold aerobic exercise has been proposed as a treatment option for symptom burden and exercise intolerance in this population. The primary aim of this study is to evaluate whether a progressive, sub-symptom threshold aerobic exercise program can alleviate symptom burden in adults with PPCS. METHODS Fifty-six adults (18-65) with PPCS (>3mos-5 yrs) will be randomized into two groups: an immediate start 12-week aerobic exercise protocol (AEP) or delayed start 6-week placebo-like stretching protocol (SP), followed by AEP. Aerobic or stretching activities will be completed 5x/week for 30 mins during the intervention. Online daily activity logs will be submitted. Exercise prescriptions for the AEP will be 70-80% of heart rate at the point of symptom exacerbation achieved on a treadmill test with heart rate monitoring. Exercise prescription will be updated every 3-weeks with a repeat treadmill test. The Rivermead Post-concussion Symptom Questionnaire will be the primary outcome measure at 6 and 12-weeks of intervention. Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention. DISCUSSION This trial will evaluate the use of aerobic exercise as an intervention for adults with PPCS, thus expanding our knowledge of this treatment option previously studied predominantly for adolescent sport-related concussion. TRIAL REGISTRATION ClinicalTrials.gov - NCT03895450 (registered 2019-Feb-11).",2020,"Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention. ","['adults with persistent post-concussive symptoms', 'adults with PPCS', 'Fifty-six adults (18-65) with PPCS (>3mos-5\u2009yrs']","['Sub-symptom threshold aerobic exercise', 'progressive, sub-symptom threshold aerobic exercise program', 'immediate start 12-week aerobic exercise protocol (AEP) or delayed start 6-week placebo-like stretching protocol (SP), followed by AEP', 'aerobic exercise', 'PPCS']","['Aerobic or stretching activities', 'exercise intolerance', 'assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220780', 'cui_str': 'Aminobutyric Acid'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl aspartate'}]",56.0,0.198792,"Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention. ","[{'ForeName': 'Leah J', 'Initials': 'LJ', 'LastName': 'Mercier', 'Affiliation': 'Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, Calgary, AB, Canada. leah.mercier@ucalgary.ca.'}, {'ForeName': 'Tak S', 'Initials': 'TS', 'LastName': 'Fung', 'Affiliation': 'Information Technologies, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Radiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Dukelow', 'Affiliation': 'Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Chantel T', 'Initials': 'CT', 'LastName': 'Debert', 'Affiliation': 'Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, Calgary, AB, Canada.'}]",BMC neurology,['10.1186/s12883-020-1622-x'] 3249,25862439,Dynamic prediction in breast cancer: proving feasibility in clinical practice using the TEAM trial.,"BACKGROUND Predictive models are an integral part of current clinical practice and help determine optimal treatment strategies for individual patients. A drawback is that covariates are assumed to have constant effects on overall survival (OS), when in fact, these effects may change during follow-up (FU). Furthermore, breast cancer (BC) patients may experience events that alter their prognosis from that time onwards. We investigated the 'dynamic' effects of different covariates on OS and developed a nomogram to calculate 5-year dynamic OS (DOS) probability at different prediction timepoints (tP) during FU. METHODS Dutch and Belgian postmenopausal, endocrine-sensitive, early BC patients enrolled in the TEAM trial were included. We assessed time-varying effects of specific covariates and obtained 5-year DOS predictions using a proportional baselines landmark supermodel. Covariates included age, histological grade, hormone receptor and HER2 status, T- and N-stage, locoregional recurrence (LRR), distant recurrence, and treatment compliance. A nomogram was designed to calculate 5-year DOS based on individual characteristics. RESULTS A total of 2602 patients were included (mean FU 6.2 years). N-stage, LRR, and HER2 status demonstrated time-varying effects on 5-year DOS. Hazard ratio (HR) functions for LRR, high-risk N-stage (N2/3), and HER2 positivity were HR = (8.427 × 0.583[Formula: see text], HR = (3.621 × 0.816[Formula: see text], and HR = (1.235 × 0.851[Formula: see text], respectively. Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)]. All other covariates were time-constant. DISCUSSION The current nomogram accounts for elapsed time since starting adjuvant endocrine treatment and optimizes prediction of individual 5-year DOS during FU for postmenopausal, endocrine-sensitive BC patients. The nomogram can facilitate in determining whether further therapy will benefit an individual patient, although validation in an independent dataset is still needed.",2015,"Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)].","['individual patients', 'Dutch and Belgian postmenopausal, endocrine-sensitive, early BC patients enrolled in the TEAM trial were included', 'breast cancer', 'A total of 2602 patients were included (mean FU 6.2 years']",[],"['5-year dynamic OS (DOS) probability', 'overall survival (OS', 'histological grade, hormone receptor and HER2 status, T- and N-stage, locoregional recurrence (LRR), distant recurrence, and treatment compliance', '5-year DOS', 'Hazard ratio (HR) functions for LRR, high-risk N-stage (N2/3), and HER2 positivity', 'higher mortality risk']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456201', 'cui_str': 'Histological grades (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2602.0,0.0691017,"Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)].","[{'ForeName': 'D B Y', 'Initials': 'DBY', 'LastName': 'Fontein', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klinten Grand', 'Affiliation': 'Department of Medical Statistics.'}, {'ForeName': 'J W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Seynaeve', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Dirix', 'Affiliation': 'Department of Medical Oncology, Academisch Ziekenhuis Sint-Augustinus Antwerp, Antwerp, Belgium.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics. Electronic address: h.putter@lumc.nl.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv146'] 3250,22782331,A randomized phase II study of irinotecan plus cisplatin versus irinotecan plus capecitabine with or without isosorbide-5-mononitrate in advanced non-small-cell lung cancer.,"BACKGROUND We investigated the efficacy of irinotecan/cisplatin (IP) versus irinotecan/capecitabine (IX) with or without isosorbide-5-mononitrate (ISMN) in chemo-naïve advanced non-small-cell lung cancer. PATIENTS AND METHODS Initially, 74 patients were randomly assigned to either IP or IX. Given the potential benefits of ISMN on chemotherapy, the protocol was amended during the study. Subsequently, 72 patients were randomly assigned to either IP + ISMN or IX + ISMN. Patients were treated with predefined second-line therapies (docetaxel/capecitabine for IP or IP + ISMN, docetaxel/cisplatin for IX or IX + ISMN) when disease progressed. RESULTS A total of 146 received treatment. Response rate (RR), median progression-free survival (PFS) and overall survival (OS) were 49%, 5.5 months, 14.5 months in IP; 33%, 3.3 months, 13.0 months in IP + ISMN; 30%, 4.3 months, 16.1 months in IX; and 25%, 3.4 months, 13.6 months in IX + ISMN, respectively. While IP arm showed a trend toward higher RR and longer PFS than IX arm, IX arm showed a trend toward longer OS than IP arm. No significant differences were observed between IP + ISMN and IX + ISMN. CONCLUSION IP showed better RR and PFS but no OS benefit when compared with IX. The addition of ISMN to IP or IX chemotherapy did not seem to improve the treatment outcome.",2012,"Response rate (RR), median progression-free survival (PFS) and overall survival (OS) were 49%, 5.5 months, 14.5 months in IP; 33%, 3.3 months, 13.0 months in IP + ISMN; 30%, 4.3 months, 16.1 months in IX; and 25%, 3.4 months, 13.6 months in IX + ISMN, respectively.","['72 patients', 'advanced non-small-cell lung cancer', 'Initially, 74 patients']","['ISMN', 'irinotecan/cisplatin (IP) versus irinotecan/capecitabine (IX) with or without isosorbide-5-mononitrate (ISMN', 'predefined second-line therapies (docetaxel/capecitabine for IP or IP + ISMN, docetaxel/cisplatin for IX or IX + ISMN', 'ISMN to IP or IX chemotherapy', 'IP + ISMN or IX + ISMN', 'irinotecan plus cisplatin versus irinotecan plus capecitabine', 'IP or IX']","['Response rate (RR), median progression-free survival (PFS) and overall survival (OS', 'higher RR and longer PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0064079', 'cui_str': 'Isosorbide Mononitrate'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",74.0,0.0774551,"Response rate (RR), median progression-free survival (PFS) and overall survival (OS) were 49%, 5.5 months, 14.5 months in IP; 33%, 3.3 months, 13.0 months in IP + ISMN; 30%, 4.3 months, 16.1 months in IX; and 25%, 3.4 months, 13.6 months in IX + ISMN, respectively.","[{'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Center for Lung Cancer; Center for Clinical Trial, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Center for Clinical Trial, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Center for Lung Cancer.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Yoon', 'Affiliation': 'Center for Lung Cancer.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Center for Lung Cancer; Center for Clinical Trial, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer. Electronic address: jslee@ncc.re.kr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds122'] 3251,20716625,Evaluation of the SCA instrument for measuring patient satisfaction with cancer care administered via paper or via the Internet.,"BACKGROUND Patients' perspectives provide valuable information on quality of care. This study evaluates the feasibility and validity of Internet administration of Service Satisfaction Scale for Cancer Care (SCA) to assess patient satisfaction with outcome, practitioner manner/skill, information, and waiting/access. PATIENTS AND METHODS Primary data collected from November 2007 to April 2008. Patients receiving cancer care within 1 year were recruited from oncology, surgery, and radiation clinics at a tertiary care hospital. An Internet-based version of the 16-item SCA was developed. Participants were randomised to Internet SCA followed by paper SCA 2 weeks later or vice versa. Seven-point Likert scale responses were converted to a 0-100 scale (minimum-maximum satisfaction). Response distribution, Cronbach's alpha, and test-retest correlations were calculated. RESULTS Among 122 consenting participants, 78 responded to initial SCA. Mean satisfaction scores for paper/Internet were 91/90 (outcome), 95/94 (practitioner manner/skill), 89/90 (information), and 86/86 (waiting/access). Response rate and item missingness were similar for Internet and paper. Except for practitioner manner/skill, test-retest correlations were robust r = 0.77 (outcome), 0.74 (information), and 0.75 (waiting/access) (all P < 0.001). CONCLUSIONS Internet SCA administration is a feasible and a valid measurement of cancer care satisfaction for a wide range of cancer diagnoses, treatment modalities, and clinic settings.",2011,This study evaluates the feasibility and validity of Internet administration of Service Satisfaction Scale for Cancer Care,"['Cancer Care', '122 consenting participants, 78 responded to initial SCA', 'Primary data collected from November 2007 to April 2008', 'Patients receiving cancer care within 1 year were recruited from oncology, surgery, and radiation clinics at a tertiary care hospital']","['Internet SCA followed by paper SCA 2 weeks later or vice versa', 'Internet SCA', 'Internet administration of Service Satisfaction Scale']","['Mean satisfaction scores', 'patient satisfaction with outcome, practitioner manner/skill, information, and waiting/access', ""Response distribution, Cronbach's alpha, and test-retest correlations"", 'Response rate and item missingness']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}]",122.0,0.0580125,This study evaluates the feasibility and validity of Internet administration of Service Satisfaction Scale for Cancer Care,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Harvard Medical School, Boston.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Dandapani', 'Affiliation': 'Harvard Medical School, Boston.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Miksad', 'Affiliation': 'Harvard Medical School, Boston; Division of Hematology/Oncology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston; Department of Radiology, Institute of Technology Assessment, Massachusetts General Hospital, Boston. Electronic address: rmiksad@bidmc.harvard.edu.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Houlihan', 'Affiliation': 'Harvard Medical School, Boston; Division of Breast Surgery, Department of Surgery.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kaplan', 'Affiliation': 'Harvard Medical School, Boston; Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Regan', 'Affiliation': 'Harvard Medical School, Boston; Department of Biostatistics, Dana Farber Cancer Institute, Boston.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Greenfield', 'Affiliation': 'Alcohol Research Group, Public Health Institute, Emeryville.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Sanda', 'Affiliation': 'Harvard Medical School, Boston; Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq417'] 3252,20716629,Prognostic significance of Ki-67 labeling index after short-term presurgical tamoxifen in women with ER-positive breast cancer.,"BACKGROUND Studies have shown that Ki-67 response after short-term neoadjuvant aromatase inhibitors may predict recurrence in postmenopausal breast cancer, whereas its prognostic effect in premenopausal women is unknown. PATIENTS AND METHODS We compared the prognostic and predictive value of baseline and post-treatment Ki-67 in 120 pre- and postmenopausal women with early-stage estrogen receptor-positive breast cancer who participated in a 4-week presurgical trial of tamoxifen. RESULTS After 7.2 years of follow-up, women with post-treatment Ki-67 in the second (14%-19%), third (20%-29%) and top (≥30%) quartiles had a recurrence hazard ratio of 2.92 [95% confidence interval (CI) 0.95-8.96], 4.37 (1.56-12.25) and 6.05 (2.07-17.65), respectively, as compared with those in the bottom quartile (<14%) (P-trend = 0.001). The risk of invasive disease recurrence was 2.2% (95% CI 0.9-5.0) per point increase in baseline Ki-67 (P-trend = 0.076) and 5.0% (95% CI 2.3-7.7) per point increase in post-tamoxifen Ki-67 (P-trend < 0.001). The risk of death was 5.5 (95% CI 1.26-23.16) times higher in patients with post-drug Ki-67 ≥20% than in those with Ki-67 <20% (P-trend = 0.006). CONCLUSIONS Ki-67 response after short-term neoadjuvant tamoxifen is a good predictor of recurrence-free survival and overall survival, further supporting its use as surrogate biomarker to personalize adjuvant treatment and to screen novel drugs cost-effectively.",2011,"The risk of death was 5.5 (95% CI 1.26-23.16) times higher in patients with post-drug Ki-67 ≥20% than in those with Ki-67 <20% (P-trend = 0.006). ","['women with ER-positive breast cancer', 'premenopausal women', '120 pre- and postmenopausal women with early-stage estrogen receptor-positive breast cancer who participated in a 4-week presurgical trial of']","['baseline and post-treatment Ki-67', 'tamoxifen']","['post-tamoxifen Ki-67', 'risk of death', 'baseline Ki-67', 'recurrence hazard ratio', 'recurrence-free survival and overall survival', 'risk of invasive disease recurrence', 'Ki-67 labeling index']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.335573,"The risk of death was 5.5 (95% CI 1.26-23.16) times higher in patients with post-drug Ki-67 ≥20% than in those with Ki-67 <20% (P-trend = 0.006). ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': 'Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan; Medical Oncology Unit, E.O. Ospedali Galliera, Genoa. Electronic address: andrea.decensi@galliera.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guerrieri-Gonzaga', 'Affiliation': 'Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gandini', 'Affiliation': 'Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': 'Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cazzaniga', 'Affiliation': 'Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': 'Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Lien', 'Affiliation': 'Hormone Laboratory, Haukeland University Hospital; Section for Endocrinology, Institute of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pruneri', 'Affiliation': 'Division of Pathology, European Institute of Oncology; University of Milan School of Medicine, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Division of Pathology, European Institute of Oncology; University of Milan School of Medicine, Milan, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': 'Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq427'] 3253,32009506,The Effectiveness of a Depression Literacy Program on Stigma and Mental Help-Seeking Among Adolescents in Malaysia: A Control Group Study With 3-Month Follow-Up.,"This study evaluated the effectiveness of a depression literacy program on depression literacy, mental health stigma, and help-seeking attitude among adolescents with a monthly household income of RM3900 a month or less (B40) in Malaysia. The program included a lecture, mental awareness activities, and a short video on depression. Residents from a boarding school for lower income families were involved in this study (N = 101); 53 of them underwent the program and another 48 served as the control group. There were significant improvements for all variables in the intervention group (better depression literacy, reduced self-stigma, reduced negative beliefs on mental health, and increased help-seeking) at posttest. However, the results were sustained at 3-month follow-up only for the depression literacy, mental help-seeking attitude, and self-stigma of seeking help variables when compared with the control group. The findings highlight the need to improve the program to enhance the effectiveness and sustainability of the outcomes.",2020,"There were significant improvements for all variables in the intervention group (better depression literacy, reduced self-stigma, reduced negative beliefs on mental health, and increased help-seeking) at posttest.","['Residents from a boarding school for lower income families were involved in this study (N = 101); 53 of them underwent the program and another 48 served as the control group', 'Adolescents in Malaysia', 'adolescents with a monthly household income of RM3900 a month or less (B40) in Malaysia']","['Depression Literacy Program', 'depression literacy program']","['depression literacy, mental help-seeking attitude, and self-stigma of seeking help variables', 'depression literacy, reduced self-stigma, reduced negative beliefs on mental health, and increased help-seeking', 'depression literacy, mental health stigma, and help-seeking attitude', 'Stigma and Mental Help-Seeking']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0557163', 'cui_str': 'Household income (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0023865', 'cui_str': 'Literacy Programs'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",101.0,0.0151857,"There were significant improvements for all variables in the intervention group (better depression literacy, reduced self-stigma, reduced negative beliefs on mental health, and increased help-seeking) at posttest.","[{'ForeName': 'Norhayati', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': ""A'isyah"", 'Initials': 'A', 'LastName': 'Mohd Safien', 'Affiliation': 'Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ching Sin', 'Initials': 'CS', 'LastName': 'Siau', 'Affiliation': 'UCSI University, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Shahar', 'Affiliation': 'Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}]","Inquiry : a journal of medical care organization, provision and financing",['10.1177/0046958020902332'] 3254,20643862,Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial.,"BACKGROUND OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI)] is unclear. PATIENTS AND METHODS within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup. RESULTS Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45-0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months). CONCLUSION This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6-12 months).",2011,"P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months).","['within OVA-301', 'relapsed ovarian cancer', 'partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial', 'patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI', '214 cases in this subgroup']","['Trabectedin plus pegylated liposomal doxorubicin', 'trabectedin plus pegylated liposomal doxorubicin (PLD']","['PFS and survival', 'median progression-free survival', 'disease progression (DP) or death', 'risk of death']","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.193055,"P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Area of Gynecologic Oncology, Valencian Institute of Oncology, Valencia, Spain. Electronic address: apoveda@fivo.org.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': ""Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Center, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Filipczyk-Cisarz', 'Affiliation': 'Chemotherapy Department, Oncology Center, Wroclaw, Poland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagberg', 'Affiliation': 'Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Department of Cancer Medicine, The Royal Mardsen Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Medical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebedinsky', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gómez', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq352'] 3255,20643863,Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval.,"BACKGROUND OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD; CentoCor Ortho Biotech Products L.P., Raritan, NJ, USA). over single-agent PLD in 672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months]. This superiority has been suggested to be due to the differential impact of subsequent (platinum) therapy. PATIENTS AND METHODS a detailed analysis of subsequent therapies and survival outcomes in the overall population and in the subsets according to platinum sensitivity was therefore conducted. RESULTS similar proportions of patients received subsequent therapy in each arm (76% versus 77%), including further platinum-based regimens (49% versus 55%). Patients in the trabectedin/PLD arm received subsequent chemotherapy at a later time (median delay 2.5 months versus PLD arm). Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). CONCLUSION the superiority of trabectedin/PLD over single-agent PLD in OVA-301 cannot be explained by differences in the extent or nature of subsequent therapies administered to these patients. On the other hand, these exploratory analyses support the hypothesis that the enhanced survival benefits in the partially platinum-sensitive subset might be due to an extended PFI leading to longer survival with subsequent platinum.",2011,"Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). ","['672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months']","['Trabectedin plus pegylated liposomal doxorubicin', 'subsequent chemotherapy', 'trabectedin plus pegylated liposomal doxorubicin']","['Overall survival', 'survival benefits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",672.0,0.0927883,"Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). ","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Section of Medicine, Institute of Cancer Research, The Royal Marsden Hospital, Sutton, Surrey, UK. Electronic address: stan.kaye@rmh.nhs.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Medical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': ""Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Center, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Filipczyk-Cisarz', 'Affiliation': 'Chemotherapy Department, Oncology Center, Wroclaw, Poland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagberg', 'Affiliation': 'Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebedinsky', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Santabárbara', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Department of Medical Oncology, Valencian Institute of Oncology, Valencia, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq353'] 3256,22689176,"A randomized phase II study investigating the addition of the specific COX-2 inhibitor celecoxib to docetaxel plus carboplatin as first-line chemotherapy for stage IC to IV epithelial ovarian cancer, Fallopian tube or primary peritoneal carcinomas: the DoCaCel study.","BACKGROUND In ovarian cancer, cyclooxygenase-2 (COX-2) overexpression is prognostic for poor survival. We investigated the efficacy of celecoxib (C), a selective COX-2 inhibitor, added to docetaxel (Taxotere)/carboplatin (DC) in advanced ovarian cancer. PATIENTS AND METHODS In a phase II, randomized study, 400 mg celecoxib b.i.d. was added to first-line DC treatment (DCC). Celecoxib was to be continued after DC termination up to 3 years. Study end points were tolerability, progression-free survival (PFS) and overall survival (OS). RESULTS 151 of 196 eligible patients were diagnosed with stage IIIC/IV disease. Median follow-up for patients alive was 32.3 months. Celecoxib was used during a mean of 8.5 months. Twenty-three of 97 DCC patients stopped celecoxib prematurely, mainly due to skin reactions. Complete biochemical response was achieved in 51/78 DC patients (65%) versus 57/78 DCC patients (75%, not significant). In both study arms, median PFS was 14.3 months and median OS 34 months. COX-2 was expressed in 82% of 120 tumor samples retrospectively recovered. The PFS and OS of patients with intermediate/high COX-2 expression were similar to that in the other patients. CONCLUSION Celecoxib did not influence PFS and OS, but interpretation of results is hampered by premature celecoxib discontinuation.",2012,"Celecoxib did not influence PFS and OS, but interpretation of results is hampered by premature celecoxib discontinuation.","['Twenty-three of 97 DCC patients stopped', '151 of 196 eligible patients were diagnosed with stage IIIC/IV disease', 'stage IC to IV epithelial ovarian cancer, Fallopian tube or primary peritoneal carcinomas', 'advanced ovarian cancer']","['specific COX-2 inhibitor celecoxib to docetaxel plus carboplatin', 'celecoxib (C), a selective COX-2 inhibitor, added to docetaxel (Taxotere)/carboplatin (DC', 'celecoxib', 'Celecoxib']","['skin reactions', 'COX-2 expression', 'tolerability, progression-free survival (PFS) and overall survival (OS', 'Complete biochemical response', 'COX-2', 'median PFS']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457153', 'cui_str': 'Stage Ic'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase 2 Inhibitors'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",196.0,0.101997,"Celecoxib did not influence PFS and OS, but interpretation of results is hampered by premature celecoxib discontinuation.","[{'ForeName': 'A K L', 'Initials': 'AKL', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, Groningen. Electronic address: a.k.l.reyners@umcg.nl.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'de Munck', 'Affiliation': 'Department of Research, Comprehensive Cancer Center The Netherlands, Utrecht.'}, {'ForeName': 'F L G', 'Initials': 'FLG', 'LastName': 'Erdkamp', 'Affiliation': 'Department of Internal Medicine, Orbis Medical Center, Sittard.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Smit', 'Affiliation': 'Department of Internal Medicine, Medical Spectrum Twente, Enschede.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoekman', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam.'}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Lalisang', 'Affiliation': 'Department of Medical Oncology, University Medical Center, Maastricht.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'de Graaf', 'Affiliation': 'Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden.'}, {'ForeName': 'A N M', 'Initials': 'ANM', 'LastName': 'Wymenga', 'Affiliation': 'Department of Internal Medicine, Medical Spectrum Twente, Enschede.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Polee', 'Affiliation': 'Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hollema', 'Affiliation': 'Department of Pathology, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': 'M A T M', 'Initials': 'MATM', 'LastName': 'van Vugt', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schaapveld', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'P H B', 'Initials': 'PHB', 'LastName': 'Willemse', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds107'] 3257,22700995,"A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer.","BACKGROUND We evaluated the efficacy and safety of ganitumab (a mAb antagonist of insulin-like growth factor 1 receptor) or conatumumab (a mAb agonist of human death receptor 5) combined with gemcitabine in a randomized phase 2 trial in patients with metastatic pancreatic cancer. PATIENTS AND METHODS Patients with a previously untreated metastatic pancreatic adenocarcinoma and an Eastern Cooperative Oncology Group (ECOG) performance status ≤1 were randomized 1 : 1 : 1 to i.v. gemcitabine 1000 mg/m(2) (days 1, 8, and 15 of each 28-day cycle) combined with open-label ganitumab (12 mg/kg every 2 weeks [Q2W]), double-blind conatumumab (10 mg/kg Q2W), or double-blind placebo Q2W. The primary end point was 6-month survival rate. Results In total, 125 patients were randomized. The 6-month survival rates were 57% (95% CI 41-70) in the ganitumab arm, 59% (42-73) in the conatumumab arm, and 50% (33-64) in the placebo arm. The grade ≥3 adverse events in the ganitumab, conatumumab, and placebo arms, respectively, included neutropenia (18/22/13%), thrombocytopenia (15/17/8%), fatigue (13/12/5%), alanine aminotransferase increase (15/5/8%), and hyperglycemia (18/2/3%). CONCLUSIONS Ganitumab combined with gemcitabine had tolerable toxicity and showed trends toward an improved 6-month survival rate and overall survival. Additional investigation into this combination is warranted. Conatumumab combined with gemcitabine showed some evidence of activity as assessed by the 6-month survival rate.",2012,"The 6-month survival rates were 57% (95% CI 41-70) in the ganitumab arm, 59% (42-73) in the conatumumab arm, and 50% (33-64) in the placebo arm.","['125 patients were randomized', 'Patients with a previously untreated metastatic pancreatic adenocarcinoma and an Eastern Cooperative Oncology Group (ECOG', 'patients with metastatic pancreatic cancer']","['conatumumab', 'gemcitabine', 'placebo', 'gemcitabine 1000 mg/m(2', 'ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine', 'double-blind conatumumab (10 mg/kg Q2W), or double-blind placebo Q2W', 'open-label ganitumab', 'ganitumab']","['6-month survival rate', 'grade ≥3 adverse events', 'hyperglycemia', 'thrombocytopenia', '6-month survival rate and overall survival', '6-month survival rates', 'tolerable toxicity', 'alanine aminotransferase increase', 'included neutropenia', 'fatigue']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C2346822', 'cui_str': 'conatumumab'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C2980089'}, {'cui': 'C2744646', 'cui_str': 'AMG 479'}, {'cui': 'C2975524', 'cui_str': 'AMG 655'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0151905', 'cui_str': 'SGPT increased'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",125.0,0.60205,"The 6-month survival rates were 57% (95% CI 41-70) in the ganitumab arm, 59% (42-73) in the conatumumab arm, and 50% (33-64) in the placebo arm.","[{'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Kindler', 'Affiliation': 'Section of Hematology/Oncology, University of Chicago Medical Center, Chicago. Electronic address: hkindler@medicine.bsd.uchicago.edu.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'US Oncology Research, Tyler.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Garbo', 'Affiliation': 'US Oncology Research, Houston.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles/Translational Oncology Research International Network, Los Angeles.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Stephenson', 'Affiliation': 'Department of Experimental Therapeutics, Greenville Hospital System University Medical Center, Greenville.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Rocha-Lima', 'Affiliation': 'Department of Medicine, University of Miami/Sylvester Comprehensive Cancer Center, Miami.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Safran', 'Affiliation': 'The Brown University Oncology Group, Rhode Island Hospital, Providence.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Cancer Care Associates Medical Group, Inc., Redondo Beach.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Kocs', 'Affiliation': 'US Oncology Research, Round Rock.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Galimi', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McGreivy', 'Affiliation': 'Global Development, Amgen Inc., South San Francisco, USA.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Bray', 'Affiliation': 'Department of Biostatistics and Epidemiology, Amgen Ltd, Cambridge, UK.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hei', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks.'}, {'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Feigal', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Loh', 'Affiliation': 'Global Development, Amgen Inc., South San Francisco, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Department of Medical Oncology/Solid Tumor Oncology, Dana-Farber Cancer Institute, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds142'] 3258,20603436,"Comorbidity, age and overall survival in cetuximab-treated patients with advanced colorectal cancer (ACRC)--results from NCIC CTG CO.17: a phase III trial of cetuximab versus best supportive care.","BACKGROUND the interplay between comorbidity, age and performance status (PS) as predictors of outcome in advanced colorectal cancer (ACRC) is poorly understood. We examined these factors as predictors of treatment toxicity and outcome in cetuximab-treated patients with ACRC. PATIENTS AND METHODS comorbidity was independently evaluated using the Charlson Comorbidity Index (CCI), a validated measure of comorbidity based on the presence of medical conditions weighted according to their effect on mortality. CCI score was correlated with clinical and outcome data. RESULTS five hundred and seventy-two patients were included; 41% were ≥ 65 years and 25% had comorbidities at randomization. In multivariate analysis (MVA) of all covariates, only older age was associated with greater comorbidity (P = 0.008). Overall survival (OS) was significantly better for patients with greater comorbidity in univariate analysis (P = 0.047). Conversely, better PS was associated with better OS in MVA (hazard ratio 1.92 for PS = 2 versus PS = 0, P < 0.0001). Age was not associated with OS (P = 0.13). Elderly patients had significantly less grade ≥ 3 vomiting (P = 0.034) but more dyspnea (P = 0.005). Patients with greater comorbidity had significantly less grade ≥ 3 vomiting (P =  0.002) but more non-neutropenic fever (P = 0.005). CONCLUSION better PS was associated with improved OS. For patients with good PS, restricting cetuximab use in the setting of significant comorbidity does not appear justified.",2011,Overall survival (OS) was significantly better for patients with greater comorbidity in univariate analysis (P = 0.047).,"['five hundred and seventy-two patients were included; 41% were ≥ 65 years and 25% had comorbidities at randomization', 'treated patients with ACRC', 'advanced colorectal cancer (ACRC', 'treated patients with advanced colorectal cancer (ACRC)--results from NCIC CTG CO.17']",['cetuximab'],"['non-neutropenic fever', 'grade ≥ 3 vomiting', 'Charlson Comorbidity Index (CCI', 'dyspnea', 'Comorbidity, age and overall survival', 'Overall survival (OS', 'CCI score']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index (assessment scale)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",572.0,0.0434541,Overall survival (OS) was significantly better for patients with greater comorbidity in univariate analysis (P = 0.047).,"[{'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Asmis', 'Affiliation': 'Department of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada. Electronic address: tasmis@ottawahospital.on.ca.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Powell', 'Affiliation': 'Department of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'Department of Medical Oncology, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Jonker', 'Affiliation': 'Department of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': 'NCIC-Clinical Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jeffery', 'Affiliation': 'Oncology Department, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Department of Medical Oncology, Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'Department of Medical Oncology, Royal Melbourne and Western Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'NCIC-Clinical Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'D-A', 'Initials': 'DA', 'LastName': 'Dueck', 'Affiliation': 'Department of Medical Oncology, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Whittom', 'Affiliation': 'Department of Medical Oncology, Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Langer', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': 'NCIC-Clinical Trials Group, Kingston, Ontario, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq309'] 3259,20603439,BRCA1 mRNA expression and outcome to neoadjuvant cisplatin-based chemotherapy in bladder cancer.,"BACKGROUND neoadjuvant chemotherapy has shown a modest benefit in muscle-invasive bladder cancer patients; however, the subset of patients most likely to benefit has not been identified. BRCA1 plays a central role in DNA repair pathways and low BRCA1 expression has been associated with sensitivity to cisplatin and longer survival in lung and ovarian cancer patients. PATIENTS AND METHODS we assessed BRCA1 messenger RNA expression levels in paraffin-embedded pre-treatment tumor samples obtained by transurethral resection from 57 patients with locally advanced bladder cancer subsequently treated with neoadjuvant cisplatin-based chemotherapy. BRCA1 levels were divided into terciles and correlated with pathological response and survival. RESULTS a significant pathological response (pT0-1) was attained in 66% (24 of 39) of patients with low/intermediate BRCA1 levels compared with 22% (4 of 18) of patients with high BRCA1 levels (P = 0.01). Median survival was 168 months in patients with low/intermediate levels and 34 months in patients with high BRCA1 levels (P = 0.002). In the multivariate analysis for survival, only BRCA1 expression levels and lymphovascular invasion emerged as independent prognostic factors. CONCLUSIONS our data suggest that BRCA1 expression may predict the efficacy of cisplatin-based neoadjuvant chemotherapy and may help to customize therapy in bladder cancer patients.",2011,"RESULTS a significant pathological response (pT0-1) was attained in 66% (24 of 39) of patients with low/intermediate BRCA1 levels compared with 22% (4 of 18) of patients with high BRCA1 levels (P = 0.01).","['57 patients with locally advanced bladder cancer subsequently treated with', 'bladder cancer patients', 'bladder cancer', 'muscle-invasive bladder cancer patients', 'lung and ovarian cancer patients']","['paraffin-embedded pre-treatment tumor samples obtained by transurethral resection', 'neoadjuvant cisplatin-based chemotherapy', 'cisplatin', 'cisplatin-based neoadjuvant chemotherapy']","['Median survival', 'BRCA1 messenger RNA expression levels', 'BRCA1 levels', 'pathological response and survival', 'survival, only BRCA1 expression levels and lymphovascular invasion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0085185', 'cui_str': 'Paraffin Embedding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1277697', 'cui_str': 'Sample obtained'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}]",,0.0447901,"RESULTS a significant pathological response (pT0-1) was attained in 66% (24 of 39) of patients with low/intermediate BRCA1 levels compared with 22% (4 of 18) of patients with high BRCA1 levels (P = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Font', 'Affiliation': 'Medical Oncology Service, Department of Medicine, Catalan Institute of Oncology, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona. Electronic address: afont@ico.scs.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Taron', 'Affiliation': 'Medical Oncology Service, Department of Medicine, Catalan Institute of Oncology, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona; Pangaea Biotech, USP Dexeus University Institute, Barcelona.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Gago', 'Affiliation': 'Urology Service, Department of Surgery, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Costa', 'Affiliation': 'Pangaea Biotech, USP Dexeus University Institute, Barcelona.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sánchez', 'Affiliation': 'Autonomous University of Madrid, Madrid.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carrato', 'Affiliation': 'Pathology Service, Hospital Germans Trias I Pujol, Badalona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mora', 'Affiliation': 'Urology Service, Department of Surgery, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Celiz', 'Affiliation': 'Medical Oncology Service, Department of Medicine, Catalan Institute of Oncology, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Medical Oncology Service, Department of Medicine, Catalan Institute of Oncology, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rodríguez', 'Affiliation': 'Medical Oncology Service, Department of Medicine, Catalan Institute of Oncology, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gimenez-Capitan', 'Affiliation': 'Pangaea Biotech, USP Dexeus University Institute, Barcelona.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Quiroga', 'Affiliation': 'Medical Oncology Service, Department of Medicine, Catalan Institute of Oncology, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Benlloch', 'Affiliation': 'Pangaea Biotech, USP Dexeus University Institute, Barcelona.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ibarz', 'Affiliation': 'Urology Service, Department of Surgery, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Medical Oncology Service, Department of Medicine, Catalan Institute of Oncology, Hospital Germans Trias i Pujol and Autonomous University of Barcelona, Badalona; Pangaea Biotech, USP Dexeus University Institute, Barcelona.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq333'] 3260,32019700,Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report.,"PURPOSE To evaluate the efficacy and safety of 0.05%, 0.025%, and 0.01% atropine eye drops over 2 years to determine which is the optimal concentration for longer-term myopia control. DESIGN Randomized, double-masked trial extended from the Low-Concentration Atropine for Myopia Progression (LAMP) Study. PARTICIPANTS Three hundred eighty-three of 438 children (87%) aged 4 to 12 years with myopia of at least -1.0 diopter (D) originally randomized to receive atropine 0.05%, 0.025%, 0.01%, or placebo once daily in both eyes in the LAMP phase 1 study were continued in this extended trial (phase 2). METHODS Children in the placebo group (phase 1) were switched to receive 0.05% atropine from the beginning of the second-year follow-up, whereas those in the 0.05%, 0.025%, and 0.01% atropine groups continued with the same regimen. Cycloplegic refraction, axial length (AL), accommodation amplitude, photopic and mesopic pupil diameter, and best-corrected visual acuity were measured at 4-month intervals. MAIN OUTCOME MEASURES Changes in spherical equivalent (SE) and AL and their differences between groups. RESULTS Over the 2-year period, the mean SE progression was 0.55±0.86 D, 0.85±0.73 D, and 1.12±0.85 D in the 0.05%, 0.025%, and 0.01% atropine groups, respectively (P = 0.015, P < 0.001, and P = 0.02, respectively, for pairwise comparisons), with mean AL changes over 2 years of 0.39±0.35 mm, 0.50±0.33 mm, and 0.59±0.38 mm (P = 0.04, P < 0.001, and P = 0.10, respectively). Compared with the first year, the second-year efficacy of 0.05% and 0.025% atropine remained similar (P >0.1), but improved mildly in the 0.01% atropine group (P = 0.04). For the phase 1 placebo group, the myopia progression was reduced significantly after switching to 0.05% atropine (SE change, 0.18 D in second year vs. 0.82 D in first year [P < 0.001]; AL elongated 0.15 mm in second year vs. 0.43 mm in first year [P < 0.001]). Accommodation loss and change in pupil size in all concentrations remained similar to the first-year results and were well tolerated. Visual acuity and vision-related quality of life remained unaffected. CONCLUSIONS Over 2 years, the efficacy of 0.05% atropine observed was double that observed with 0.01% atropine, and it remained the optimal concentration among the studied atropine concentrations in slowing myopia progression.",2020,"Visual acuity and vision-related quality of life remained unaffected. ","['Three hundred eighty-three of 438 children (87%) aged 4 to 12 years with myopia of at least -1.0 diopter (D', 'Myopia\xa0Progression (LAMP', 'Children in the']","['Low-Concentration Atropine', 'placebo', 'atropine']","['Visual acuity and vision-related quality of life', 'efficacy and safety', 'Cycloplegic refraction, axial length (AL), accommodation amplitude, photopic and mesopic pupil diameter, and best-corrected visual acuity', 'Changes in spherical equivalent (SE) and AL', 'mean SE progression', 'tolerated', 'Myopia Progression (LAMP', 'Accommodation loss and change in pupil size', 'myopia progression']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0855713', 'cui_str': 'Wet refraction'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",438.0,0.526804,"Visual acuity and vision-related quality of life remained unaffected. ","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Yam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Hong Kong Eye Hospital, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China. Electronic address: yamcheuksing@cuhk.edu.hk.'}, {'ForeName': 'Fen Fen', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Shu Min', 'Initials': 'SM', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ka Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Simon T', 'Initials': 'ST', 'LastName': 'Ko', 'Affiliation': 'Department of Ophthalmology, Tung Wah Eastern Hospital, Hong Kong, China.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Hong Kong Eye Hospital, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Li Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Chi Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}]",Ophthalmology,['10.1016/j.ophtha.2019.12.011'] 3261,20696677,"Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma: a Japanese Gynecologic Oncology Group study (JGOG2041).","BACKGROUND The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma. PATIENTS AND METHODS Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma were randomly assigned to receive docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC) every 3 weeks until disease progression or adverse events prohibited further therapy. Among these regimens, the study evaluated the tumor response rate as the primary end point as well as toxicity. RESULTS Ninety patients were enrolled. Of them, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Tumor response rates were 51.7%, 48.3%, and 60.0% in DP, DC, and TC, respectively (P = 0.65). The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC. These toxicity profiles were not significantly different. CONCLUSION The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.",2011,"The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC.","['patients with advanced or recurrent endometrial carcinoma', 'Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma', 'advanced or recurrent endometrial carcinoma', 'Of them, 88 were eligible and consequently 29, 29, and 30 patients', 'Ninety patients were enrolled']","['docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC', 'docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin', 'taxane plus platinum combination therapies', 'taxane plus platinum']","['toxicity', 'febrile neutropenia', 'Tumor response rates', 'efficacy and safety', 'tumor response rate', 'grade 3/4 diarrhea', 'grade 3/4 neutropenia', 'toxic effects', 'grade 3 neurotoxicity', 'toxicity profiles', 'grade 3/4 thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",90.0,0.0660055,"The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nomura', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aoki', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo. Electronic address: aoki@sc.itc.keio.ac.jp.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Takahashi', 'Affiliation': 'Department of Biostatistics, Kitasato University, Tokyo.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katsumata', 'Affiliation': 'Department of Medical Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Department of Obstetrics and Gynecology, Kinki University School of Medicine, Osaka.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Konishi', 'Affiliation': 'Department of Obstetrics and Gynecology, Kyoto University Graduate School of Medicine, Kyoto.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Jobo', 'Affiliation': 'Department of Obstetrics and Gynecology, Social Insurance Sagamino Hospital, Sagamihara.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hatae', 'Affiliation': 'Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hiura', 'Affiliation': 'Department of Gynecology, National Hospital Organization Shikoku Cancer Center, Matsuyama.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yaegashi', 'Affiliation': 'Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq401'] 3262,20929964,Long-term effects of anastrozole on bone mineral density: 7-year results from the ATAC trial.,"BACKGROUND This 'Arimidex', Tamoxifen, Alone or in Combination (ATAC) trial sub-study examined the effects of anastrozole and tamoxifen on bone mineral density (BMD) following 5 years of treatment. PATIENTS AND METHODS Lumbar spine and total hip BMD were assessed at years 6 and 7 in a total of 71 eligible patients. In total, 50 patients had evaluable data. RESULTS Following anastrozole treatment, the lumbar spine median BMD increased by 2.35% (P=0.04) and 4.02% (P=0.0004) at years 6 and 7, while total hip median BMD increased by 0.71% (P=0.3) and 0.5% (P=0.8). After tamoxifen treatment, lumbar spine median BMD decreased by 0.79% (P=0.2) and 0.30% (P=0.9) at years 6 and 7, while total hip median BMD decreased by 2.09% (P=0.0003) and 2.52% (P=0.0002). Patients with a normal BMD or who were osteopenic at 5 years did not become osteoporotic. CONCLUSIONS Anastrozole treatment-related bone loss did not continue into the off-treatment follow-up period. The recovery in lumbar spine BMD and absence of further loss at the hip is consistent with the reduction in the annual rate of fracture observed after treatment cessation in the main ATAC trial.",2011,", the lumbar spine median BMD increased by 2.35% (P=0.04) and 4.02% (P=0.0004) at years 6 and 7, while total hip median BMD increased by 0.71% (P=0.3) and 0.5% (P=0.8).","['50 patients had evaluable data', 'Patients with a normal BMD or who were osteopenic at 5 years did not become osteoporotic', '5 years of treatment', 'Lumbar spine and total hip BMD were assessed at years 6 and 7 in a total of 71 eligible patients']","['tamoxifen', 'Anastrozole', 'Tamoxifen, Alone or in Combination (ATAC', 'anastrozole treatment', 'anastrozole and tamoxifen', 'anastrozole']","['lumbar spine BMD', 'bone loss', 'bone mineral density (BMD', 'total hip median BMD', 'bone mineral density', 'lumbar spine median BMD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",71.0,0.100247,", the lumbar spine median BMD increased by 2.35% (P=0.04) and 4.02% (P=0.0004) at years 6 and 7, while total hip median BMD increased by 0.71% (P=0.3) and 0.5% (P=0.8).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, University of Sheffield, Sheffield.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Diagnostic Radiology, Imaging Science and Biomedical Engineering, University of Manchester, Manchester.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Clack', 'Affiliation': 'Clinical Development, AstraZeneca, Cheshire.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'The Christie NHS Foundation Trust, University of Manchester, Manchester.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Queen Mary University of London, Wolfson Institute of Preventive Medicine, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mackey', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Alberta Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Coleman', 'Affiliation': 'Cancer Research Centre, Weston Park Hospital, Sheffield, UK. Electronic address: r.eastell@sheffield.ac.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq541'] 3263,20935058,Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation.,"BACKGROUND Explore safety and efficacy of three palonosetron-containing regimens for emesis prevention over 7 days in multiple myeloma (MM) patients receiving melphalan (100 mg/m(2)) and hematopoietic stem cell transplantation (HSCT). PATIENTS AND METHODS Randomized, double-blind pilot study in MM patients (n=73) receiving 1, 2, or 3 days of 0.25 mg palonosetron (30-s i.v. bolus) 30 min before melphalan (days -2 and -1) and HSCT (day 0). Patients received dexamethasone (20 mg i.v., days -2 and -1) immediately before or after study drug/placebo. Daily diaries recorded emesis, rescue medication, nausea duration, and adverse events (AEs). RESULTS Seven-day complete protection (no emesis) occurred in 41.7% [95% confidence interval (CI) 22.1% to 63.4%], 41.7% (95% CI 22.1% to 63.4%), and 44.0% (95% CI 24.2% to 65.1%) of patients receiving 1, 2, or 3 days of palonosetron, respectively (P=0.43). Complete response (emesis free without rescue medication) occurred in 8.3%, 20.8%, and 20.0% (P=0.14). Common AEs (≥10%) were mild-to-moderate diarrhea, constipation, headache, insomnia, and flatulence. No serious AEs occurred. CONCLUSIONS Palonosetron with dexamethasone was safe and effective in preventing emesis in MM patients receiving melphalan and HSCT. This pilot study with a limited number of patients suggests that multiple doses of palonosetron could be more effective than a single dose in making patients emesis free without need for rescue medication. However, even multiple doses of palonosetron resulted in only 20% of patients being emesis free without rescue medication, suggesting that further improvement will require development of more effective combination antiemetic therapy.",2011,"RESULTS Seven-day complete protection (no emesis) occurred in 41.7% [95% confidence interval (CI) 22.1% to 63.4%], 41.7% (95% CI 22.1% to 63.4%), and 44.0% (95% CI 24.2% to 65.1%) of patients receiving 1, 2, or 3 days of palonosetron, respectively (P=0.43).","['MM patients (n=73) receiving 1, 2, or 3 days of 0.25 mg', 'MM patients receiving', 'myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation', '100 mg/m(2)) and hematopoietic stem cell transplantation (HSCT', 'multiple myeloma (MM) patients receiving']","['palonosetron', 'placebo', 'dexamethasone', 'melphalan and HSCT', 'melphalan', 'palonosetron-containing regimens']","['Daily diaries recorded emesis, rescue medication, nausea duration, and adverse events (AEs', 'Complete response (emesis free without rescue medication', 'mild-to-moderate diarrhea, constipation, headache, insomnia, and flatulence', 'complete protection (no emesis', 'safe and effective in preventing emesis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]",,0.262392,"RESULTS Seven-day complete protection (no emesis) occurred in 41.7% [95% confidence interval (CI) 22.1% to 63.4%], 41.7% (95% CI 22.1% to 63.4%), and 44.0% (95% CI 24.2% to 65.1%) of patients receiving 1, 2, or 3 days of palonosetron, respectively (P=0.43).","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Giralt', 'Affiliation': 'Adult BMT Service, Memorial Sloan Kettering Cancer Center, New York. Electronic address: GiraltS@mskcc.org.'}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Mangan', 'Affiliation': 'Fox Chase Temple BMT Program, Philadelphia.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Bubalo', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Beveridge', 'Affiliation': 'Fairfax-Northern Virginia Hematology-Oncology P.C., Fairfax.'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Hurd', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem.'}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Mendoza', 'Affiliation': 'Adult BMT Service, Memorial Sloan Kettering Cancer Center, New York.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Rubenstein', 'Affiliation': 'Medical & Scientific Affairs, Eisai Inc., Woodcliff Lake.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'DeGroot', 'Affiliation': 'Medical & Scientific Affairs, Eisai Inc., Woodcliff Lake.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Schuster', 'Affiliation': 'Hematopoietic Stem Cell Transplantation Program, Stony Brook University, Stony Brook, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq457'] 3264,20724576,Primary mediastinal B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: results of the Mabthera International Trial Group study.,"BACKGROUND The aim of this subgroup analysis of the Mabthera International Trial Group study was to evaluate the impact of chemotherapy and rituximab in primary mediastinal B-cell lymphoma (PMBCL) in comparison to other diffuse large B-cell lymphoma (DLBCL). METHODS Patients were randomly assigned to six cycles of CHOP-like regimens with or without rituximab. RESULTS Of 824 patients enrolled, 87 had PMBCL and 627 other types of DLBCL. Rituximab increased the rates of complete remission (unconfirmed) in both PMBCL (from 54% to 80%, P = 0.015) and DLBCL (from 72% to 87%, P < 0.001). In PMBCL, rituximab virtually eliminated progressive disease (PD) (2.5% versus 24%, P < 0.001), whereas without rituximab, PD was more frequent in PMBCL than in DLBCL (24% versus 10%, P = 0.010). With a median observation time of 34 months, 3-year event-free survival (EFS) was improved by rituximab for PMBCL (78% versus 52%, P = 0.012) and for DLBCL (81% versus 61%, P < 0.001). Overall survival benefit was similar for DLBCL (93% versus 85%, P < 0.001) and PMBCL (89% versus 78%, P = 0.158). CONCLUSION In young patients with PMBCL (age-adjusted International Prognostic Index 0-1), rituximab added to six cycles of CHOP-like chemotherapy increases response rate and EFS to the same extent as other DLBCL. The combination of rituximab with CHOP chemotherapy is an effective treatment in PMBCL with good prognosis features.",2011,"Overall survival benefit was similar for DLBCL (93% versus 85%, P < 0.001) and PMBCL (89% versus 78%, P = 0.158). ","['Patients', 'primary mediastinal B-cell lymphoma (PMBCL) in comparison to other diffuse large B-cell lymphoma (DLBCL', '824 patients enrolled, 87 had PMBCL and 627 other types of DLBCL']","['CHOP-like chemotherapy', 'chemotherapy and rituximab', 'Rituximab', 'rituximab with CHOP chemotherapy', 'CHOP-like regimens with or without rituximab', 'CHOP-like chemotherapy with or without rituximab']","['3-year event-free survival (EFS', 'PMBCL', 'DLBCL', 'Overall survival benefit', 'rates of complete remission', 'progressive disease (PD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0079731', 'cui_str': 'B-Cell Lymphomas'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",824.0,0.133557,"Overall survival benefit was similar for DLBCL (93% versus 85%, P < 0.001) and PMBCL (89% versus 78%, P = 0.158). ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rieger', 'Affiliation': 'Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany. Electronic address: michael.rieger@med.uni-heidelberg.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Österborg', 'Affiliation': 'Departments of Oncology, Haematology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pettengell', 'Affiliation': ""St George's University of London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Dalhousie University, Halifax, Nova Scotia for the NCIC Clinical Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gill', 'Affiliation': 'Department of Haematology, Princess Alexandra Hospital, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Department of Lymphoma, Maria Sklodowska-Curie Institute and Oncology Centre, Warszawa, Poland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kuhnt', 'Affiliation': 'Clinical Trial Centre Leipzig, University of Leipzig, Leipzig.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Loeffler', 'Affiliation': 'Institute of Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pfreundschuh', 'Affiliation': 'Saarland University Medical School, Homburg, Germany.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Ho', 'Affiliation': 'Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq418'] 3265,20732932,A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer.,"BACKGROUND Neoadjuvant systemic therapy (NST) before surgery is a standard option for patients with early breast cancer (EBC) that allows in vivo chemosensitivity testing. Given the promising activity of pemetrexed plus doxorubicin in metastatic breast cancer, it was reasonable to evaluate the utility of this combination as part of an NST regimen in EBC. PATIENTS AND METHODS Patients with untreated operable T2-T4a-c N0-2 M0 breast cancer were randomly assigned to receive either four cycles of pemetrexed 500 mg/m(2) plus doxorubicin 60 mg/m(2) every 3 weeks (q3w) followed by four cycles of docetaxel 100 mg/m(2) q3w (AP-D) or four cycles of doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) q3w followed by four cycles of docetaxel 100 mg/m(2) q3w (AC-D). Surgery was carried out within 2 months after last chemotherapy. Primary end point was pathological complete response (pCR) rate in the breast. Secondary end points included clinical response rate, rate of histologically negative axillary lymph nodes, toxicity, and disease-free survival. RESULTS From September 2005 to August 2007, 257 patients were randomly allocated to 17 sites. Median age was 48 and 49 years for AP-D and AC-D, respectively. Overall pCR rates were 16.5% for AP-D and 20.2% for AC-D. With AP-D, pCR rate was 17.8% for hormone receptor (HR)-negative patients and 15.9% for HR-positive patients. With AC-D, pCR rates were 42.9% and 7.8% for HR-negative and HR-positive patients, respectively. Clinical response rates were 59.5% in the AP-D group and 68.1% in the AC-D group. The rate of histologically negative axillary lymph nodes was 53% in both groups. Both treatments were well tolerated. Median disease-free survival is currently not mature. CONCLUSIONS AP-D and AC-D are well tolerated and active as NST in EBC. Of note, AC-D had a higher pCR rate in HR-negative tumors, whereas AP-D had more activity if HRs were expressed.",2011,"With AC-D, pCR rates were 42.9% and 7.8% for HR-negative and HR-positive patients, respectively.","['Patients with untreated operable T2-T4a-c N0-2 M0 breast cancer', 'early breast cancer', 'metastatic breast cancer', 'From September 2005 to August 2007, 257 patients were randomly allocated to 17 sites', 'patients with early breast cancer (EBC']","['docetaxel versus doxorubicin plus cyclophosphamide', 'doxorubicin plus pemetrexed', 'pemetrexed plus doxorubicin', 'Neoadjuvant systemic therapy (NST', 'pemetrexed 500 mg/m(2) plus doxorubicin', 'docetaxel 100 mg/m(2) q3w (AP-D) or four cycles of doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) q3w followed by four cycles of docetaxel', 'docetaxel']","['activity if HRs', 'pathological complete response (pCR) rate', 'clinical response rate, rate of histologically negative axillary lymph nodes, toxicity, and disease-free survival', 'Clinical response rates', 'tolerated', 'Median disease-free survival', 'Overall pCR rates', 'rate of histologically negative axillary lymph nodes', 'pCR rates', 'pCR rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4074670', 'cui_str': 'pemetrexed 500 MG'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node structure (body structure)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",257.0,0.0409452,"With AC-D, pCR rates were 42.9% and 7.8% for HR-negative and HR-positive patients, respectively.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Department of Gynecology and Obstetrics, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany. Electronic address: andreas.schneeweiss@med.uni-heidelberg.de.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Department of Gynecology and Obstetrics, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruiz', 'Affiliation': 'Oncology Department, Instituto Valenciano de Oncología, Valencia, Spain.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Manikhas', 'Affiliation': 'Breast Cancer Department, City Oncology Dispensary, St Petersburg, Russian Federation.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bottini', 'Affiliation': 'Breast Unit, Azienda Ospedaliera Istituti Ospitalieri, Cremona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Center for Breast Diseases, Vivantes-Klinikum am Urban, Berlin.'}, {'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Sinn', 'Affiliation': 'Department of Pathology, University of Heidelberg, Heidelberg.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mansouri', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kennedy', 'Affiliation': 'Lilly United Kingdom, Erl Wood Manor, Surrey, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bauknecht', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq400'] 3266,20843984,Addition of cetuximab to first-line chemotherapy in patients with advanced non-small-cell lung cancer: a cost-utility analysis.,"BACKGROUND Adding cetuximab to standard chemotherapy results in a moderate increase of overall survival in patients with advanced non-small-cell lung cancer (NSCLC), but the cost-effectiveness is unknown. MATERIALS AND METHODS A Markov model was constructed based on the results of the First-Line ErbituX in lung cancer randomized trial, adding cetuximab to cisplatin-vinorelbine first-line chemotherapy in patients with advanced NSCLC. The primary outcome was the incremental cost-effectiveness ratio (ICER) of adding cetuximab, expressed as cost per quality-adjusted life year (QALY) gained, and relative to a willingness-to-pay threshold of €60 000/QALY. The impact of cetuximab intermittent dosing schedules on the ICER was also evaluated. RESULTS Adding cetuximab to standard chemotherapy leads to a gain of 0.07 QALYs per patient at an additional cost of €26 088. The ICER for adding cetuximab to chemotherapy was €376 205 per QALY gained. Intermittent cetuximab dosing schedules resulted in ICERs per QALY gained between €31 300 and €83 100, under the assumption of equal efficacy. CONCLUSIONS From a health economic perspective, the addition of cetuximab to standard first-line chemotherapy in patients with epidermal growth factor receptor-expressing advanced NSCLC cannot be recommended to date, due to a high ICER compared with other health care interventions. Treatment schedules resulting in more favorable cost-utility ratios should be evaluated.",2011,"Intermittent cetuximab dosing schedules resulted in ICERs per QALY gained between €31 300 and €83 100, under the assumption of equal efficacy. ","['patients with advanced non-small-cell lung cancer', 'patients with epidermal growth factor receptor-expressing advanced NSCLC', 'patients with advanced NSCLC', 'patients with advanced non-small-cell lung cancer (NSCLC']","['cetuximab', 'cetuximab to cisplatin-vinorelbine first-line chemotherapy', 'cetuximab to standard first-line chemotherapy', 'cetuximab to first-line chemotherapy']","['ICERs per QALY', 'favorable cost-utility ratios', 'incremental cost-effectiveness ratio (ICER) of adding cetuximab, expressed as cost per quality-adjusted life year (QALY) gained, and relative to a willingness-to-pay threshold of €60\u2009000/QALY', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0328961,"Intermittent cetuximab dosing schedules resulted in ICERs per QALY gained between €31 300 and €83 100, under the assumption of equal efficacy. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Joerger', 'Affiliation': 'Department of Oncology and Hematology, Cantonal Hospital, St Gallen. Electronic address: markus.joerger@kssg.ch.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matter-Walstra', 'Affiliation': 'Institute of Pharmaceutical Medicine, University of Basel, Basel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Früh', 'Affiliation': 'Department of Oncology and Hematology, Cantonal Hospital, St Gallen.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Kühnel', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Bern.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Szucs', 'Affiliation': 'Institute of Pharmaceutical Medicine, University of Basel, Basel.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pestalozzi', 'Affiliation': 'Department of Medical Oncology, University Hospital, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schwenkglenks', 'Affiliation': 'Institute of Pharmaceutical Medicine, University of Basel, Basel.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq431'] 3267,22767583,Comparing long-term toxicity and efficacy of combined modality treatment including extended- or involved-field radiotherapy in early-stage Hodgkin's lymphoma.,"BACKGROUND To evaluate long-term toxicity and efficacy of a combined modality strategy including extended-field radiotherapy (EF-RT) or involved-field radiotherapy (IF-RT), the German Hodgkin Study Group carried out a follow-up analysis in patients with early unfavorable Hodgkin's lymphoma (HL). PATIENTS AND METHODS One thousand two hundred and four patients were randomized to four cycles of chemotherapy followed by either 30 Gy EF- or 30 Gy IF-RT (HD8 trial); 532 patients in each treatment arm were eligible. RESULTS At 10 years, no arm differences were revealed with respect to freedom from treatment failure (FFTF) (79.8% versus 79.7%), progression-free survival (79.8% versus 80.0%), and overall survival (86.4% versus 87.3%). Non-inferiority of IF-RT was demonstrated for the primary end point FFTF (95% confidence interval for hazard ratio 0.72-1.25). Elderly patients had a poorer outcome when treated with EF-RT. So far, 15.0% of patients in arm A and 12.2% in arm B died, mostly due to secondary malignancies (5.3% versus 3.4%) or HL (3.2% versus 3.4%). After EF-RT, there were more secondary malignancies overall (58 versus 45), especially acute myeloid leukemias (11 versus 4). CONCLUSION Radiotherapy intensity reduction to IF-RT does not result in poorer long-term outcome but is associated with less acute toxicity and might be associated with less secondary malignancies.",2012,IF-RT was demonstrated for the primary end point FFTF (95% confidence interval for hazard ratio 0.72-1.25).,"['Elderly patients', 'One thousand two hundred and four patients', ""patients with early unfavorable Hodgkin's lymphoma (HL"", ""early-stage Hodgkin's lymphoma"", 'HD8 trial); 532 patients in each treatment arm were eligible']","['extended-field radiotherapy (EF-RT) or involved-field radiotherapy (IF-RT', '30 Gy EF- or 30 Gy IF-RT', 'combined modality treatment including extended- or involved-field radiotherapy', 'chemotherapy', 'EF-RT']","['acute myeloid leukemias', 'freedom from treatment failure (FFTF', 'secondary malignancies', 'overall survival', 'progression-free survival', 'acute toxicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0162643'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",1204.0,0.122903,IF-RT was demonstrated for the primary end point FFTF (95% confidence interval for hazard ratio 0.72-1.25).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sasse', 'Affiliation': 'First Department of Internal Medicine, University Hospital Cologne, Cologne; German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Klimm', 'Affiliation': 'First Department of Internal Medicine, University Hospital Cologne, Cologne; German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Görgen', 'Affiliation': 'German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Heyden-Honerkamp', 'Affiliation': 'German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lohri', 'Affiliation': 'Department of Internal Medicine, Kantonsspital Liestal, Liestal, Switzerland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Koch', 'Affiliation': 'Third Department of Internal Medicine, Klinikum Osnabrück, Osnabrück.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Fifth Department of Internal Medicine, Klinikum Nuernberg, Nuernberg.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Trenn', 'Affiliation': 'Department of Internal Medicine, Knappschaftskrankenhaus Bottrop, Bottrop.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Finke', 'Affiliation': 'First Department of Internal Medicine, University Hospital Freiburg, Freiburg.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Müller', 'Affiliation': 'Department of Radiotherapy, University Hospital Cologne, Cologne.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': 'German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Eich', 'Affiliation': 'Department of Radiotherapy, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'First Department of Internal Medicine, University Hospital Cologne, Cologne; German Hodgkin Study Group, Cologne, Germany. Electronic address: a.engert@uni-koeln.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds110'] 3268,22771827,BAYPAN study: a double-blind phase III randomized trial comparing gemcitabine plus sorafenib and gemcitabine plus placebo in patients with advanced pancreatic cancer.,"BACKGROUND Sorafenib is an oral anticancer agent targeting Ras-dependent signaling and angiogenic pathways. A phase I trial demonstrated that the combination of gemcitabine and sorafenib was well tolerated and had activity in advanced pancreatic cancer (APC) patients. The BAYPAN study was a multicentric, placebo-controlled, double-blind, randomized phase III trial comparing gemcitabine/sorafenib and gemcitabine/placebo in the treatment of APC. PATIENTS AND METHODS The patient eligibility criteria were locally advanced or metastatic pancreatic adenocarcinoma, no prior therapy for advanced disease and a performance status of zero to two. The primary end point was progression-free survival (PFS). The patients received gemcitabine 1000 mg/m(2) i.v., weekly seven times followed by 1 rest week, then weekly three times every 4 weeks plus sorafenib 200 mg or placebo, two tablets p.o., twice daily continuously. RESULTS Between December 2006 and September 2009, 104 patients were enrolled on the study (52 pts in each arm) and 102 patients were treated. The median and the 6-month PFS were 5.7 months and 48% for gemcitabine/placebo and 3.8 months and 33% for gemcitabine/sorafenib (P = 0.902, stratified log-rank test), respectively. The median overall survivals were 9.2 and 8 months, respectively (P = 0.231, log-rank test). The overall response rates were similar (19 and 23%, respectively). CONCLUSION The addition of sorafenib to gemcitabine does not improve PFS in APC patients.",2012,"The median overall survivals were 9.2 and 8 months, respectively (P = 0.231, log-rank test).","['APC patients', '104 patients were enrolled on the study (52 pts in each arm) and 102 patients were treated', 'advanced pancreatic cancer (APC) patients', 'patients with advanced pancreatic cancer', 'Between December 2006 and September 2009', 'patient eligibility criteria were locally advanced or metastatic pancreatic adenocarcinoma, no prior therapy for advanced disease and a performance status of zero to two']","['gemcitabine plus sorafenib and gemcitabine plus placebo', 'gemcitabine and sorafenib', 'placebo', 'gemcitabine/sorafenib and gemcitabine/placebo', 'gemcitabine/placebo', 'gemcitabine 1000 mg/m(2) i.v', 'gemcitabine/sorafenib', 'sorafenib 200 mg or placebo', 'sorafenib to gemcitabine']","['overall response rates', 'median overall survivals', 'tolerated and had activity', 'PFS', 'median and the 6-month PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C1677790', 'cui_str': 'sorafenib 200 MG'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",104.0,0.290339,"The median overall survivals were 9.2 and 8 months, respectively (P = 0.231, log-rank test).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille. Electronic address: goncalvesa@marseille.fnclcc.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gilabert', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'François', 'Affiliation': 'Department of Medical Oncology, Centre Antoine Lacassagne, Nice.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dahan', 'Affiliation': 'Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille; Department of Digestive Oncology, Hôpital de le Timone, Assistance Publique-Hôpitaux de Marseille, Marseille.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Perrier', 'Affiliation': 'Digestive Oncology Unit, Hôpital Saint-Joseph, Marseille.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lamy', 'Affiliation': 'Department of Oncology, Centre Hospitalier Bretagne Sud (Lorient), Lorient.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Re', 'Affiliation': 'Medicine Unit, Centre Hospitalier Antibes Juan-les-Pins, Antibes.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Largillier', 'Affiliation': 'Department of Oncology, Centre azuréen de cancérologie, Mougins.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gasmi', 'Affiliation': 'Department of Gastro-enterology, Hôpital Nord APHM, Marseille.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Tchiknavorian', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Toulon, Toulon, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Esterni', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Clinical Investigation Center 9502, Marseille.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Genre', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Clinical Investigation Center 9502, Marseille.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moureau-Zabotto', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giovannini', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.'}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': 'Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille; Department of Digestive Oncology, Hôpital de le Timone, Assistance Publique-Hôpitaux de Marseille, Marseille.'}, {'ForeName': 'J-R', 'Initials': 'JR', 'LastName': 'Delpero', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Turrini', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Viens', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Raoul', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds135'] 3269,20880999,Paclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group (HeCOG).,"BACKGROUND Paclitaxel (Taxol) and vinorelbine have shown synergism of cytotoxic effects in vitro and clinical activity in phase I and II studies. This combination was compared prospectively with the paclitaxel/gemcitabine regimen in non-operable non-small-cell lung cancer. PATIENTS AND METHODS Chemotherapy-naive patients, stage IIIbwet and IV with performance status (0-1), were randomized to receive paclitaxel 200 mg/m(2) on day 1 plus gemcitabine 1 gm/m(2) (group A) on days 1 and 8 every 3 weeks or paclitaxel 80 mg/m(2) plus vinorelbine 22.5 mg/m(2) (group B) on days 1, 8 and 15 every 4 weeks. RESULTS A total of 398 out of 415 patients were eligible for analysis on intent-to-treat basis (group A: 196, group B: 202). Progression-free survival (PFS) was 5.0 months [95% confidence interval (CI) 4.3-5.6] and 4.4 months (95% CI 3.7-5.2) for groups A and B respectively (P=0.365). Median survival was 11.1 months (95% CI 9.2-13.0) and 8.6 months (95% CI 7.0-10.2) for groups A and B respectively (P = 0.147). Grade 3/4 neutropenia and leukopenia were worse in group B (P<0.001, in both cases). Febrile neutropenia and severe infections were more prominent (P<0.001, P=0.029 respectively) in group B. CONCLUSION Although response rate, PFS and survival were non-different in both groups, toxicity was significantly worse in group B and therefore further investigation of P-Vin is of no value.",2011,"Febrile neutropenia and severe infections were more prominent (P<0.001, P=0.029 respectively) in group B. CONCLUSION ","['patients with advanced non-small-cell lung cancer', 'Chemotherapy-naive patients, stage IIIbwet and IV with performance status (0-1', 'A total of 398 out of 415 patients were eligible for analysis on intent-to-treat basis (group A: 196, group B: 202', 'non-operable non-small-cell lung cancer']","['Paclitaxel (Taxol) and vinorelbine', 'paclitaxel 200 mg/m(2) on day 1 plus gemcitabine', 'Paclitaxel and gemcitabine versus paclitaxel and vinorelbine', 'paclitaxel/gemcitabine', 'paclitaxel 80 mg/m(2) plus vinorelbine']","['toxicity', 'Median survival', 'Progression-free survival (PFS', 'Febrile neutropenia and severe infections', 'Grade 3/4 neutropenia and leukopenia', 'response rate, PFS and survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",415.0,0.0918327,"Febrile neutropenia and severe infections were more prominent (P<0.001, P=0.029 respectively) in group B. CONCLUSION ","[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Kosmidis', 'Affiliation': 'Department of Medical Oncology, Hygeia Hospital, Athens. Electronic address: parkosmi@otenet.gr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountzilas', 'Affiliation': 'Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Eleftheraki', 'Affiliation': 'Section of Biostatistics, Hellenic Cooperative Oncology Group Data Office, Athens.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Kalofonos', 'Affiliation': 'Division of Oncology, University Hospital of Patras, Patras.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pentheroudakis', 'Affiliation': 'Department of Medical Oncology, University of Ioannina School of Medicine, Ioannina.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Skarlos', 'Affiliation': 'Department of Medical Oncology, Metropolitan Hospital, Piraeus.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bafaloukos', 'Affiliation': 'Department of Medical Oncology, Metropolitan Hospital, Piraeus.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pectasides', 'Affiliation': '2nd Department of Internal Medicine-Propaedeutic, Oncology Section, University General Hospital Attikon, Athens.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Samantas', 'Affiliation': '3rd Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boukovinas', 'Affiliation': 'Department of Medical Oncology, Theagenio Hospital, Thessaloniki.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lambaki', 'Affiliation': 'Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katirtzoglou', 'Affiliation': 'Oncology Unit, 3rd Department of Medicine, Athens Medical School, Sotiria General Hospital, Athens, Greece.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bakogiannis', 'Affiliation': 'Department of Medical Oncology, Hygeia Hospital, Athens.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Syrigos', 'Affiliation': 'Oncology Unit, 3rd Department of Medicine, Athens Medical School, Sotiria General Hospital, Athens, Greece.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq445'] 3270,31054159,Direct infant ultraviolet light exposure is associated with eczema and immune development: a critical appraisal.,"AIM Rueter et al. aimed to 'determine the effects of early postnatal vitamin D supplementation on infant eczema and immune development'. SETTING AND DESIGN This was a double-blind randomized placebo-controlled trial with an additional nonrandomized exploratory analysis on the effects of ultraviolet (UV) exposure led from a hospital setting. STUDY EXPOSURE Vitamin D (400 iU daily) drops or placebo drops (coconut and palm kernel oil) were allocated randomly to 195 infants born to families with a first-degree relative with atopic disease. Eighty-six of these infants were allocated personal UV dosimeters in a nonrandomized fashion to measure UV light (290-380 nm) exposure until 3 months of age. OUTCOMES Eczema and wheeze were assessed at 3 and 6 months, and 25 immune function markers were assessed at 6 months of age. Infant vitamin D levels and immune functions were measured at 6 months of age. RESULTS Although vitamin D levels were significantly greater in infants in the intervention group than in those in the placebo group at 3 and 6 months of age, there was no difference in eczema between groups at either time point (10·0% vs. 6·7% at 3 months and 21·8 vs. 19·3% at 6 months for the vitamin D and placebo groups, respectively). In the subset of infants given a dosimeter, those with eczema had less UV light exposure (median 555 J m -2 ) than infants who did not develop eczema (median 998 J m -2 ). Across the 25 immune functions, UV light exposure was inversely correlated with interleukin-2, granulocyte macrophage colony-stimulating factor and eotaxin production by Toll-like receptor ligands. CONCLUSIONS Vitamin D supplementation in high-risk infants increased vitamin D levels but did not reduce eczema. Exploratory post-hoc analyses in a nonrandomized subset showed an association between greater direct UV light exposure and reduction of eczema. The authors claim that their 'findings indicate that UV light exposure appears more beneficial than vitamin D supplementation as an allergy prevention strategy in early life'.",2020,"Across the 25 immune functions, UV light exposure was inversely correlated with IL-2, GM-CSF, and eotaxin production to Toll-like receptor ligands. ",['195 infants born to families with a first-degree relative with atopic disease'],"['personal UV dosimeters in a non-randomised fashion to measure UV light', 'vitamin D supplementation', 'placebo', 'Vitamin D supplementation', 'early postnatal vitamin D supplementation', 'ultraviolet (UV', 'placebo drops (coconut and palm kernel oil']","['vitamin D levels', 'direct UV light exposure and reduction of eczema', 'eczema', 'infant eczema and immune development', 'Vitamin D levels', 'UV light exposure', 'Eczema and wheeze', 'IL-2, GM-CSF, and eotaxin production to Toll-like receptor ligands']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4082307', 'cui_str': 'Dosimeters'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet Light'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0009210', 'cui_str': 'Cocos nucifera'}, {'cui': 'C0982306', 'cui_str': 'palm kernel oil'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet Light'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0033268'}, {'cui': 'C0670896'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]",,0.42201,"Across the 25 immune functions, UV light exposure was inversely correlated with IL-2, GM-CSF, and eotaxin production to Toll-like receptor ligands. ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maslin', 'Affiliation': 'UK Dermatology Clinical Trials Network, University of Nottingham, Kings Meadow Campus, Lenton Lane, Nottingham, NG7 2NR, U.K.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Veitch', 'Affiliation': 'UK Dermatology Clinical Trials Network, University of Nottingham, Kings Meadow Campus, Lenton Lane, Nottingham, NG7 2NR, U.K.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'UK Dermatology Clinical Trials Network, University of Nottingham, Kings Meadow Campus, Lenton Lane, Nottingham, NG7 2NR, U.K.'}]",The British journal of dermatology,['10.1111/bjd.18087'] 3271,32006484,Baseline Characteristics of Participants in the Treatment of Advanced Glaucoma Study: A Multicenter Randomized Controlled Trial.,"PURPOSE To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study). DESIGN Pragmatic randomized control trial (RCT). METHODS Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI). RESULTS A total of 453 patients were recruited. The mean visual field MD was -15.0 dB ± 6.3 in the index eye and -6.2 dB in the non-index eye. Of index eyes (HPA ""severe"" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3. CONCLUSIONS TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.",2020,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","['Four hundred and fifty-three patients were recruited', 'patients presenting with advanced open angle glaucoma in a publicly funded health service', 'Participants with newly diagnosed advanced glaucoma in at least one eye were recruited', 'participants in the Treatment of Advanced Glaucoma Study (TAGS', 'participants enrolled in the Treatment of Advanced Glaucoma Study (TAGS) DESIGN', 'Patients with open angle glaucoma presenting with advanced glaucoma in at least one eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria of severe defect']","['primary augmented trabeculectomy or primary medical management', 'TAGS']","['severe visual field mean deviation (MD', 'mean LogMAR visual acuity of the index eye', 'mean visual field MD', 'Visual field profile defined by the HPA classification, clinical characteristics, Quality of life measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3) and Glaucoma Profile Instrument (GPI']","[{'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",453.0,0.352301,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Nottingham University Hospital, Nottingham, United Kingdom. Electronic address: anthony.king@nottingham.ac.uk.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fernie', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burr', 'Affiliation': 'University of St. Andrews, St. Andrews, Fife, United Kingdom.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Azuara-Blanco', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Sparrow', 'Affiliation': 'University Hospitals Bristol National Health Service Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Kernohan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.01.026'] 3272,31859245,"Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.","BACKGROUND Belantamab mafodotin (GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent activity in the phase 1 DREAMM-1 study in heavily pre-treated patients with relapsed or refractory multiple myeloma. We further investigated the safety and activity of belantamab mafodotin in the DREAMM-2 study. METHODS DREAMM-2 is an open-label, two-arm, phase 2 study done at 58 multiple myeloma specialty centres in eight countries. Patients (aged ≥18 years) with relapsed or refractory multiple myeloma with disease progression after three or more lines of therapy and who were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody with an Eastern Cooperative Oncology Group performance status of 0-2 were recruited, centrally randomly assigned (1:1) with permuted blocks (block size 4), and stratified by previous lines of therapy (≤4 vs >4) and cytogenetic features to receive 2·5 mg/kg or 3·4 mg/kg belantamab mafodotin via intravenous infusion every 3 weeks on day 1 of each cycle until disease progression or unacceptable toxicity. The intention-to-treat population comprised all randomised patients, regardless of treatment administration. The safety population comprised all patients who received at least one dose of belantamab mafodotin. The primary outcome was the proportion of randomly assigned patients in the intention-to-treat population who achieved an overall response, as assessed by an independent review committee. This study is registered with ClinicalTrials.gov, NCT03525678, and is ongoing. FINDINGS Between June 18, 2018, and Jan 2, 2019, 293 patients were screened and 196 were included in the intention-to-treat population (97 in the 2·5 mg/kg cohort and 99 in the 3·4 mg/kg cohort). As of June 21, 2019 (the primary analysis data cutoff date), 30 (31%; 97·5% CI 20·8-42·6) of 97 patients in the 2·5 mg/kg cohort and 34 (34%; 23·9-46·0) of 99 patients in the 3·4 mg/kg cohort achieved an overall response. The most common grade 3-4 adverse events in the safety population were keratopathy (in 26 [27%] of 95 patients in the 2·5 mg/kg cohort and 21 [21%] of 99 patients in the 3·4 mg/kg cohort), thrombocytopenia (19 [20%] and 33 [33%]), and anaemia (19 [20%] and 25 [25%]); 38 (40%) of 95 patients in the 2·5 mg/kg cohort and 47 (47%) of 99 in the 3·4 mg/kg cohort reported serious adverse events. Two deaths were potentially treatment related (one case of sepsis in the 2·5 mg/kg cohort and one case of haemophagocytic lymphohistiocytosis in the 3·4 mg/kg cohort). INTERPRETATION Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma. FUNDING GlaxoSmithKline.",2020,"INTERPRETATION Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma. ","['23·9-46·0) of 99 patients in the 3·4 mg/kg cohort achieved an overall response', 'Between June 18, 2018, and Jan 2, 2019, 293 patients were screened and 196 were included in the intention-to-treat population (97 in the 2·5 mg/kg cohort and 99 in the 3·4 mg/kg cohort', 'heavily pre-treated patients with relapsed or refractory multiple myeloma', 'relapsed or refractory multiple myeloma', '58 multiple myeloma specialty centres in eight countries', 'Patients (aged ≥18 years) with relapsed or refractory multiple myeloma with disease progression after three or more lines of therapy and who were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody with an Eastern Cooperative Oncology Group performance status of 0-2', 'patients with relapsed or refractory multiple myeloma']",['Belantamab mafodotin'],"['serious adverse events', 'thrombocytopenia', 'anaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1443643', 'cui_str': 'Proteasome Endopeptidase Complex Inhibitors'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",293.0,0.268505,"INTERPRETATION Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma. ","[{'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA. Electronic address: sloni01@emory.edu.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Badros', 'Affiliation': 'University of Maryland at Baltimore, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Trudel', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, NY, USA.'}, {'ForeName': 'Al-Ola', 'Initials': 'AO', 'LastName': 'Abdallah', 'Affiliation': 'University of Kansas Cancer Center, Fairway, KS, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Lendvai', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York City, NY, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Attaya', 'Initials': 'A', 'LastName': 'Suvannasankha', 'Affiliation': 'Indiana University Cancer Center, Indianapolis, IN, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany; University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Karlin', 'Affiliation': 'Haematology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Libby', 'Affiliation': 'Division of Medical Oncology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Arnulf', 'Affiliation': 'Immuno-hématologie, Hôpital Saint-Louis, APHP, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'CHRU de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': 'CHU de Bordeaux, Hôpital Haut Lévêque, Pessac, France.'}, {'ForeName': 'K Martin', 'Initials': 'KM', 'LastName': 'Kortüm', 'Affiliation': 'Universitätsklinikum Würzburg, Medizinische Klinik II, Würzburg, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodríguez-Otero', 'Affiliation': 'Clínica Universidad de Navarra-Pamplona, Navarra, Spain.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Baz', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'CHU de Nantes - Hôtel Dieu Service Hématologie Clinique, Nantes, France.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hoos', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zhi', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'January', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lewis', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Roxanne C', 'Initials': 'RC', 'LastName': 'Jewell', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Elisha J', 'Initials': 'EJ', 'LastName': 'Dettman', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Simona Degli', 'Initials': 'SD', 'LastName': 'Esposti', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Opalinska', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30788-0'] 3273,32012398,A randomized controlled trial of a nurse-led education pathway for asthmatic children from outpatient to home.,"BACKGROUND Education for asthmatic children in the outpatient department is insufficient. AIM To evaluate the efficacy of a nurse-led education pathway, a standard education programme, on children with asthma. METHODS One hundred and eighty participants enrolled and were randomly assigned to either the control group or the intervention group. The intervention group received predetermined step-by-step education sessions based on the self-designed education pathway, while the control group received usual care. Asthma control, health-related quality of life, and health-care utilization measures were taken at baseline and at follow-up visits between February 2016 and May 2018. RESULTS Significantly higher scores for health-related quality of life and inhaler technique at the third-month visit and asthma control test at the sixth-month visit were seen in the intervention group. The numbers of unscheduled physician visits and school absences were lower in the intervention group than in the control group within 6 months. However, no significant differences were observed in emergency department visits and hospitalizations. CONCLUSION The nurse-led education pathway could be considered effective for children with asthma visiting the outpatient department.",2020,The numbers of unscheduled physician visits and school absences were lower in the intervention group than in the control group within 6 months.,"['children with asthma', 'asthmatic children from outpatient to home', 'children with asthma visiting the outpatient department', 'One hundred and eighty participants enrolled', 'asthmatic children']","['predetermined step-by-step education sessions based on the self-designed education pathway, while the control group received usual care', 'nurse-led education pathway', 'nurse-led education pathway, a standard education programme']","['emergency department visits and hospitalizations', 'health-related quality of life and inhaler technique', 'Asthma control, health-related quality of life, and health-care utilization measures', 'numbers of unscheduled physician visits and school absences']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1689985', 'cui_str': 'Absence'}]",180.0,0.0303662,The numbers of unscheduled physician visits and school absences were lower in the intervention group than in the control group within 6 months.,"[{'ForeName': 'Guozhen', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yaoji', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'School of Nursing, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Mo', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yucui', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",International journal of nursing practice,['10.1111/ijn.12823'] 3274,31102257,"Secukinumab dosing optimization in patients with moderate-to-severe plaque psoriasis: results from the randomized, open-label OPTIMISE study.","BACKGROUND Secukinumab is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin-17A. OBJECTIVES To assess the efficacy and safety of different maintenance dosing regimens of secukinumab 300 mg based on Psoriasis Area and Severity Index (PASI) response at week 24 in patients with moderate-to-severe plaque psoriasis. METHODS OPTIMISE was a randomized, open-label, rater-blinded phase IIIb study. Patients (n = 1647) received secukinumab 300 mg at baseline; weeks 1, 2, 3 and 4; and every 4 weeks (q4w) to week 24. At week 24, PASI 90 responders (≥ 90% improvement in PASI; n = 1306) were randomized to secukinumab 300 mg q4w (n = 644) or q6w (n = 662) to week 52, and PASI ≥ 75 to < 90 responders (n = 206) were randomized to secukinumab 300 mg q4w (n = 114) or q2w (n = 92) to week 52. RESULTS PASI 90 response was maintained at week 52 by 85·7% of patients with q4w dosing vs. 74·9% with q6w dosing (odds ratio 1·91, 95% confidence interval 1·44-2·55). The primary end point, noninferiority of q6w vs. q4w dosing, was not met. In PASI ≥ 75 to < 90 responders, the proportion of patients with PASI 90 response at week 52 was numerically higher in the q2w vs. the q4w group (57% vs. 46·5%, respectively, P = 0·10). Heavier patients (≥ 90 kg) demonstrated numerically higher PASI 90 response with the q2w (57·1%) vs. the q4w regimen (40%, P = 0·11). CONCLUSIONS Standard q4w dosing of secukinumab 300 mg is the optimal dosing regimen to achieve and maintain clear or almost clear skin. Patients with body weight ≥ 90 kg not achieving PASI 90 at week 24 may benefit from the q2w dosing regimen. What's already known about this topic? Individual responses to biologics in patients with psoriasis vary considerably and there may be a need to individualize treatment. Dose optimization strategies of currently available biologic drugs have been investigated mainly in rheumatic disorders. Secukinumab has shown long-term PASI 90/100 responses (percentage improvement in Psoriasis Area and Severity Index) to year 5 in patients with moderate-to-severe plaque psoriasis when used at the dose of 300 mg every 4 weeks. What does this study add? Standard every 4 week (q4w) dosing of secukinumab 300 mg is the optimal regimen to achieve and maintain clear or almost clear skin at week 52; the majority of the patients (85·7%) maintain PASI 90 at week 52. Superiority of intensified (q2w) dosing over the q4w regimen could not be claimed. However, patients with a higher body weight (≥ 90 kg) not achieving PASI 90 response at week 24 may benefit from q2w dosing.",2020,"Heavier subjects (≥90 kg) demonstrated numerically higher PASI 90 response with q2w (57.1%) vs q4w regimen (39.6%, P=0.1053). ",['patients with moderate to severe plaque psoriasis'],"['secukinumab', 'secukinumab 300 mg q4w', 'Secukinumab dosing optimization']","['PASI response', 'proportion of subjects with PASI 90 response', 'non-inferiority', 'PASI 90 response', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0299626,"Heavier subjects (≥90 kg) demonstrated numerically higher PASI 90 response with q2w (57.1%) vs q4w regimen (39.6%, P=0.1053). ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Department of Dermatology, Toulouse University and Larrey Hospital, Toulouse, France.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Hôpital Archet, CHU de Nice, Nice, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsianakas', 'Affiliation': 'University of Münster, Münster, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sieder', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rissler', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pournara', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orsenigo', 'Affiliation': 'Novartis Farma SpA, Origgio, Italy.'}]",The British journal of dermatology,['10.1111/bjd.18143'] 3275,31277797,"Aflibercept for Radiation Maculopathy Study: A Prospective, Randomized Clinical Study.","PURPOSE To evaluate 2 treatment approaches to intravitreal vascular endothelial growth factor antagonist therapy in radiation maculopathy comparing aflibercept delivered by either a 6-week treatment interval or treat-and-adjust interval. DESIGN Randomized, prospective clinical trial. METHODS Forty consecutive patients were enrolled in an institutional review board-approved clinical trial and randomized to aflibercept treatment via 1 of 2 regimens: (1) fixed, every-6-weeks treatment or (2) variable, treat-and-adjust treatment centered around 6 weeks. All patients had a diagnosis of treated uveal melanoma with documented tumor control. All patients showed visually compromising radiation maculopathy confirmed by a decline in best-corrected visual acuity (BCVA) and spectral-domain (SD) OCT documentation of radiation maculopathy. MAIN OUTCOME MEASURES Best-corrected visual acuity and SD OCT central retinal thickness at 1 year. RESULTS Thirty-nine of 40 patients completed the trial (97.5%) with 1 year of follow-up. Baseline study entry BCVA was 20/63 and was maintained at 20/62 at study conclusion at 60 weeks (1 year). At baseline, SD OCT mean central retinal thickness was 432 μm and improved to 294 μm at 60 weeks (P < 0.02). At the study conclusion, 42.5% of eyes (17/40) showed better than 20/50 BCVA, and only 5% of eyes (2/40) showed a BCVA worse than 20/200. In the every-6-weeks interval treatment arm, patients received 9 injections, whereas in the treat-and-adjust study arm, patients received 8.4 injections (P = 0.88, not significant). One patient experienced an inflammatory response after aflibercept injection, but this did not occur again for this patient, nor for any other study injections (1/400 injections [0.0025%]). No patients demonstrated endophthalmitis or metastatic disease or died during the study window. CONCLUSIONS Aflibercept seems to limit vision loss associated with radiation maculopathy. In this randomized, prospective clinical study, no difference was found between a fixed 6-week treatment interval and a variable treat-and-adjust interval because virtually all patients required treatment every 6 weeks and were not able to extend. Remarkably, almost half of all treated patients maintained BCVA of 20/50 or better throughout 1 year of treatment. Aflibercept is effective in treating radiation maculopathy, but requires an ongoing treatment approach.",2019,"All patients showed visually compromising radiation maculopathy confirmed by a decline in best-corrected visual acuity (BCVA) and spectral-domain (SD) OCT documentation of radiation maculopathy. ","['All patients had a diagnosis of treated uveal melanoma with documented tumor control', 'Radiation Maculopathy Study', 'Forty consecutive patients were enrolled in an institutional review board-approved clinical trial and randomized to', 'Thirty-nine of 40 patients completed the trial (97.5%) with 1 year of follow-up']","['Aflibercept', 'aflibercept treatment via 1 of 2 regimens: (1) fixed, every-6-weeks treatment or (2) variable, treat-and-adjust treatment centered around 6 weeks', 'intravitreal vascular endothelial growth factor antagonist therapy']","['visually compromising radiation maculopathy', 'Best-corrected visual acuity and SD OCT central retinal thickness', 'endophthalmitis or metastatic disease or died', 'BCVA', 'SD OCT mean central retinal thickness', 'inflammatory response', 'corrected visual acuity (BCVA) and spectral-domain (SD) OCT documentation of radiation maculopathy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0220633', 'cui_str': 'Uveal melanoma'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0014236', 'cui_str': 'Ophthalmia'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}]",40.0,0.296266,"All patients showed visually compromising radiation maculopathy confirmed by a decline in best-corrected visual acuity (BCVA) and spectral-domain (SD) OCT documentation of radiation maculopathy. ","[{'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Murray', 'Affiliation': 'Murray Ocular Oncology and Retina, Miami, Florida. Electronic address: tmurray@murraymd.com.'}, {'ForeName': 'Azeema', 'Initials': 'A', 'LastName': 'Latiff', 'Affiliation': 'Murray Ocular Oncology and Retina, Miami, Florida.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Villegas', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Ophthalmology, University of Puerto Rico, San Juan, Puerto Rico; Department of Surgery, Ponce Health Sciences University, Ponce, Puerto Rico.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Gold', 'Affiliation': 'Murray Ocular Oncology and Retina, Miami, Florida.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.02.009'] 3276,31816306,Nonopioid versus opioid analgesia after hospital discharge following cesarean delivery: a randomized equivalence trial.,"OBJECTIVE To determine whether pain score after cesarean delivery is equivalent among women receiving outpatient nonopioid vs opioid analgesics. STUDY DESIGN In this trial 170 women with cesarean delivery were randomized to outpatient ibuprofen plus acetaminophen (nonopioid, n=85) or ibuprofen plus hydrocodone-acetaminophen (opioid, n=85). Primary outcome was pain score on a visual analog scale at 2-4 weeks postpartum, which was obtained from 149 (88%) women. Treatments were considered equivalent if the difference between the mean pain scores of each group and its 95% confidence interval were between -10 and 10 mm. A zero-inflated negative binomial model was used to estimate the difference between group means. RESULTS Treatments were not equivalent; mean pain score was lower (better) in the nonopioid group (12.3±19.5 vs 15.9±20.4 mm, adjusted mean difference, 4.8; 95% CI, -2.1 to 11.9 mm). CONCLUSION Pain score 2-4 weeks after cesarean delivery was lower in women receiving nonopioid analgesics.",2020,"RESULTS Treatments were not equivalent; mean pain score was lower (better) in the nonopioid group (12.3±19.5 vs 15.9±20.4 mm, adjusted mean difference, 4.8; 95% CI, -2.1 to 11.9 mm). ","['women receiving outpatient nonopioid vs opioid analgesics', '170 women with cesarean delivery', 'after hospital discharge following cesarean delivery']","['Nonopioid versus opioid analgesia', 'ibuprofen plus acetaminophen (nonopioid, n=85) or ibuprofen plus hydrocodone-acetaminophen']","['mean pain score', 'pain score on a visual analog scale', 'pain score', 'mean pain scores', 'Pain score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0002772', 'cui_str': 'Analgesics, Opioid'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",170.0,0.515064,"RESULTS Treatments were not equivalent; mean pain score was lower (better) in the nonopioid group (12.3±19.5 vs 15.9±20.4 mm, adjusted mean difference, 4.8; 95% CI, -2.1 to 11.9 mm). ","[{'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Dinis', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston. Electronic address: Jenifer.DinisBallestas@bcm.edu.'}, {'ForeName': 'Eleazar', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Blackwell', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.001'] 3277,31080168,Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study.,"PURPOSE To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). DESIGN AQUA was a multicenter, open-label, single-arm, phase 4 study. PARTICIPANTS Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. METHODS Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. MAIN OUTCOME MEASURES The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. RESULTS A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was -175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. CONCLUSIONS Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept.",2019,"CONCLUSIONS Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities.","['Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME', 'Patients with Diabetic Macular Edema Treated with', '553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set', 'patients with diabetic macular edema (DME) treated with']","['intravitreal aflibercept (EYLEA', 'Intravitreal Aflibercept', 'intravitreal aflibercept']","['near and distant activities', 'Adverse events', 'Vision-Related Quality of Life', 'Change in NEI VFQ-25 score', 'change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA', 'mean change in BCVA', 'mean NEI VFQ-25 total score', 'NEI VFQ-25 total score', 'change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}]","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",553.0,0.148225,"CONCLUSIONS Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities.","[{'ForeName': 'Justus G', 'Initials': 'JG', 'LastName': 'Garweg', 'Affiliation': 'Swiss Eye Institute, Rotkreuz, and Berner Augenklinik am Lindenhofspital, Bern, Switzerland. Electronic address: justus.garweg@augenklinik-bern.ch.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Stefanickova', 'Affiliation': 'Department of Ophthalmology, Comenius University, University Hospital Ružinov, Bratislava, Slovakia.'}, {'ForeName': 'Carel', 'Initials': 'C', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmelter', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Niesen', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Sowade', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'NIHR Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2019.03.012'] 3278,32013568,Short-Term Intermittent Hypoxic Resistance Training Does Not Impair Osteogenic Response in Sea Level Residents.,"Background: Osteogenic responses induced by training under hypoxia remain unclear. We aimed to investigate whether intermittent hypoxic resistance training affects osteogenic responses. Materials and Methods: Sixteen male participants underwent resistance training under normoxia (NRT; n  = 7) or hypoxia (HRT; O 2  = 14.4%, n  = 9), twice a week for 8 weeks. The HRT group exercised and rested for 30 minutes under hypoxia, with total hypoxic exposure time in one session of ∼60 minutes. At pre- and postexperiment, bone mineral density (BMD) of the whole body and right proximal femur was measured. At the first and last training sessions, bone alkaline phosphatase (BAP), osteocalcin (OC), cross-linked N-telopeptide of type I collagen (NTx), type I collagen cross-linked C-telopeptide (ICTP), interleukin-6 (IL-6), and blood lactate (La) concentration were analyzed at rest and postexercise. Results: BMD did not change with training and hypoxia. Although BAP, OC, and ICTP levels at rest significantly increased with training ( p  < 0.01, 0.05, and 0.05, respectively), they did not change with hypoxia. NTx and IL-6 did not change. Additionally, changing patterns of bone markers and La induced by a single bout of exercise were similar among groups in both training sessions. Conclusions: Short-term resistance training enhanced overall bone metabolism, regardless of the oxygen level. Hypoxia has no effects on osteogenic responses.",2020,"Although BAP, OC, and ICTP levels at rest significantly increased with training ( p  < 0.01, 0.05, and 0.05, respectively), they did not change with hypoxia.","['Sixteen male participants underwent', 'Sea Level Residents']","['resistance training under normoxia (NRT; n \u2009=\u20097) or hypoxia (HRT', 'intermittent hypoxic resistance training', 'Short-Term Intermittent Hypoxic Resistance Training']","['I collagen (NTx), type I collagen cross-linked C-telopeptide (ICTP), interleukin-6 (IL-6), and blood lactate ', 'La) concentration', 'BMD', 'osteogenic responses', 'overall bone metabolism', 'bone mineral density (BMD) of the whole body and right proximal femur', 'BAP, OC, and ICTP levels', 'bone alkaline phosphatase (BAP), osteocalcin (OC', 'NTx and IL-6']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0908518', 'cui_str': '5-((76)Br)bromo-3-((2-azetidinyl)methoxy)pyridine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1868883', 'cui_str': 'Bone alkaline phosphatase'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}]",16.0,0.0188146,"Although BAP, OC, and ICTP levels at rest significantly increased with training ( p  < 0.01, 0.05, and 0.05, respectively), they did not change with hypoxia.","[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Honda', 'Affiliation': 'Department of Health and Sport Sciences, School of Health Sciences, Asahi University, Mizuho, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, Nagoya, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, Kita-ku, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, Kita-ku, Japan.'}]",High altitude medicine & biology,['10.1089/ham.2019.0089'] 3279,19850639,Single circulating tumor cell detection and overall survival in nonmetastatic breast cancer.,"BACKGROUND Circulation of cancer cells in the blood is a mandatory step for metastasis, but circulating tumor cells (CTC) have a low metastatic efficiency in preclinical animal models. In this prospective study, we reported the clinical outcome of nonmetastatic breast cancer patients according to CTC detection. PATIENTS AND METHODS In 115 nonmetastatic patients diagnosed with large operable or locally advanced breast cancer, we prospectively detected CTC using the CellSearch system before and after neoadjuvant chemotherapy in a phase II trial (REMAGUS02). RESULTS At baseline, 23% of patients were CTC positive, but only 10% had >1 CTC/7.5 ml of blood. After a median follow-up of 36 months, CTC detection before chemotherapy was an independent prognostic factor for both distant metastasis-free survival [DMFS; P = 0.01, relative risk (RR) = 5.0, 95% confidence interval (CI) 1.4-17] and overall survival (OS; P = 0.007, RR = 9, 95% CI 1.8-45). CTC detection after chemotherapy was of less significance (P = 0.07 and 0.09, respectively). Moreover, CTC detection showed interesting characteristics as an individual predictive test for metastatic relapses (sensibility 55%, specificity 81%, and global accuracy 77%). CONCLUSIONS Detection of > or =1 CTC/7.5 ml before neoadjuvant chemotherapy can accurately predict OS. Our findings may change the clinical management of nonmetastatic breast cancer and indicate that the metastatic efficiency of CTC could be higher than previously reported.",2010,"After a median follow-up of 36 months, CTC detection before chemotherapy was an independent prognostic factor for both distant metastasis-free survival [DMFS; P = 0.01, relative risk (RR) =","['nonmetastatic breast cancer', '115 nonmetastatic patients diagnosed with large operable or locally advanced breast cancer', 'nonmetastatic breast cancer patients according to CTC detection']",[],"['CTC detection', 'overall survival']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",115.0,0.0692165,"After a median follow-up of 36 months, CTC detection before chemotherapy was an independent prognostic factor for both distant metastasis-free survival [DMFS; P = 0.01, relative risk (RR) =","[{'ForeName': 'F-C', 'Initials': 'FC', 'LastName': 'Bidard', 'Affiliation': 'CirCe laboratory, Institut Curie, Paris; Department of Medical Oncology, Institut Curie, Paris.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mathiot', 'Affiliation': 'CirCe laboratory, Institut Curie, Paris; Hematology laboratory, Institut Curie, Paris.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Villejuif.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Department of Medical Oncology, Centre René Huguenin, Saint Cloud.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Giachetti', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Louis, Paris.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Cremoux', 'Affiliation': 'CirCe laboratory, Institut Curie, Paris; Pharmacology laboratory, Institut Curie, Paris.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marty', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Louis, Paris.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'CirCe laboratory, Institut Curie, Paris; Department of Medical Oncology, Institut Curie, Paris; University Paris Descartes, Paris, France. Electronic address: jean-yves.pierga@curie.net.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp391'] 3280,31736335,"Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction: Results From the DAPA-HF Trial.","BACKGROUND Goals of management in patients with heart failure and reduced ejection fraction include reducing death and hospitalizations, and improving health status (symptoms, physical function, and quality of life). In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), sodium-glucose cotransporter-2 inhibitor, dapagliflozin, reduced death and hospitalizations, and improved symptoms in patients with heart failure and reduced ejection fraction. In this analysis, we examine the effects of dapagliflozin on a broad range of health status outcomes, using the Kansas City Cardiomyopathy Questionnaire (KCCQ). METHODS KCCQ was evaluated at randomization, 4 and 8 months. Patients were divided by baseline KCCQ total symptom score (TSS); Cox proportional hazards models examined the effects of dapagliflozin on clinical events across these subgroups. We also evaluated the effects of dapagliflozin on KCCQ-TSS, clinical summary score, and overall summary score. Responder analyses were performed to compare proportions of dapagliflozin versus placebo-treated patients with clinically meaningful changes in KCCQ at 8 months. RESULTS A total of 4443 patients had available KCCQ at baseline (median KCCQ-TSS, 77.1 [interquartile range, 58.3-91.7]). The effects of dapagliflozin vs placebo on reducing cardiovascular death or worsening heart failure were consistent across the range of KCCQ-TSS (lowest to highest tertile: hazard ratio, 0.70 [95% CI, 0.57-0.86]; hazard ratio, 0.77 [95% CI, 0.61-0.98]; hazard ratio, 0.62 [95% CI, 0.46-0.83]; P for heterogeneity=0.52). Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, clinical summary score, and overall summary score at 8 months (2.8, 2.5 and 2.3 points higher versus placebo; P <0.0001 for all). Fewer patients treated with dapagliflozin had a deterioration in KCCQ-TSS (odds ratio, 0.84 [95% CI, 0.78-0.90]; P <0.0001); and more patients had at least small, moderate, and large improvements (odds ratio, 1.15 [95% CI, 1.08-1.23]; odds ratio, 1.15 [95% CI, 1.08-1.22]; odds ratio, 1.14 [95% CI, 1.07-1.22]; number needed to treat=14, 15, and 18, respectively; P <0.0001 for all; results consistent for KCCQ clinical summary score and overall summary score). CONCLUSIONS Dapagliflozin reduced cardiovascular death and worsening heart failure across the range of baseline KCCQ, and improved symptoms, physical function, and quality of life in patients with heart failure and reduced ejection fraction. Furthermore, dapagliflozin increased the proportion of patients experiencing at least small, moderate, and large improvements in health status; these effects were clinically important. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT03036124.",2020,"Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, -CSS and - OSS at 8 months (2.8, 2.5 and 2.3 points higher vs. placebo; P <0.0001 for all).","['patients with HFrEF', 'Patients with Heart Failure and Reduced Ejection Fraction', 'patients with heart failure and reduced ejection fraction (HFrEF']","['dapagliflozin', 'Dapagliflozin', 'dapagliflozin versus placebo']","['cardiovascular death or worsening HF', 'Symptoms, Function and Quality of Life', 'symptoms, physical function and quality of life', 'death and hospitalizations, and improving health status (symptoms, physical function and quality of life', 'mean KCCQ-TSS, -CSS and - OSS', 'Kansas City Cardiomyopathy Questionnaire (KCCQ', 'KCCQ-TSS, clinical summary score (CSS) and overall summary score (OSS', 'death and hospitalizations, and improved symptoms', 'cardiovascular death', 'deterioration in KCCQ-TSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",4443.0,0.191932,"Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, -CSS and - OSS at 8 months (2.8, 2.5 and 2.3 points higher vs. placebo; P <0.0001 for all).","[{'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (M.N.K.).""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Argentina (M.D.).'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St Michael's Hospital, University of Toronto, Canada (S.V.).""}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, Brazil (J.C.N.).'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, Suita Osaka, Japan (M.K.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet, Department of Cardiology, University of Copenhagen, Denmark (L.K.).'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Argentina (F.A.M.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland (P.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Niklasson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044138'] 3281,19940004,Gemcitabine and capecitabine in previously anthracycline-treated metastatic breast cancer: a multicenter phase II study (SOLTI 0301 trial).,"BACKGROUND On the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancer patients. Main objectives were to assess its efficacy and safety profile. PATIENTS AND METHODS Seventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m(2), i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m(2) b.i.d., days 1-14 every 21 days. RESULTS Overall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3-4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand-foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-related deaths occurred. CONCLUSION Combination of gemcitabine and capecitabine is an active and safe regimen in anthracycline-pretreated breast cancer patients.",2010,"Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population.","['Seventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated', 'metastatic breast cancer', 'anthracycline-pretreated breast cancer patients', 'advanced anthracycline-pretreated breast cancer patients', 'previously anthracycline-treated metastatic breast cancer']","['capecitabine', 'gemcitabine and capecitabine', 'gemcitabine 1000 mg/m(2), i.v', 'Gemcitabine and capecitabine', 'capecitabine and gemcitabine']","['Overall response rate', 'febrile neutropenia', 'Median time to progression', 'Clinical benefit rate', 'neutropenia', 'asymptomatic liver toxicity', 'toxic effects', 'efficacy and safety profile', 'asthenia']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}]",,0.0303373,"Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population.","[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'Medical Oncology Department, University Hospital 12 de Octubre, Madrid. Electronic address: eciruelos@hotmail.com.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cortés-Funes', 'Affiliation': 'Medical Oncology Department, University Hospital 12 de Octubre, Madrid.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Mayordomo', 'Affiliation': 'Medical Oncology Division, Hospital Clínico de Zaragoza, Zaragoza.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Medical Oncology Division, Hospital Clínico de Valencia, Valencia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ojeda', 'Affiliation': 'Medical Oncology Division, Hospital de Sant Pau, Barcelona.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'García', 'Affiliation': 'Medical Oncology Division, Hospital Morales Meseguer, Murcia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Rodríguez', 'Affiliation': 'Medical Oncology Division, Hospital Clínico de Salamanca, Salamanca.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'Medical Oncology Division, Hospital Clínico de Barcelona, Barcelona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gómez', 'Affiliation': ""Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Medical Oncology Department, University Hospital 12 de Octubre, Madrid.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Andrés', 'Affiliation': 'Medical Oncology Division, Hospital Clínico de Zaragoza, Zaragoza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'Medical Oncology Division, Hospital Clínico de Valencia, Valencia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mendiola', 'Affiliation': 'Medical Oncology Department, University Hospital 12 de Octubre, Madrid.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ""Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp536'] 3282,19940007,Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study.,"BACKGROUND This phase I dose-escalation study was designed to determine the maximum tolerated dose (MTD) and recommended dose of cetuximab administered on an every-second-week schedule to patients with metastatic colorectal cancer, on the basis of safety, pharmacokinetic and pharmacodynamic evaluation. PATIENTS AND METHODS The study comprised two parts: a 6-week cetuximab monotherapy dose-escalation phase and a subsequent combination therapy phase, during which patients received cetuximab, at the same dose/schedule as in the monotherapy phase, followed by irinotecan plus infusional 5-fluorouracil/folinic acid (FOLFIRI). Patients in the control group received cetuximab as a 400 mg/m(2) initial dose, then 250 mg/m(2)/week and in the dose-escalation group, at 400-700 mg/m(2), every second week. RESULTS Sixty-two patients were included in the study. The MTD of cetuximab administered on an every-second-week schedule was not reached. The safety profiles were similar across all groups. Response rates in the cetuximab monotherapy and combination therapy phases were 15% and 42%, respectively. Trough levels for the 500, 600 mg/m(2) and standard weekly regimens were comparable. CONCLUSION Cetuximab can be safely administered once every second week at doses between 400 and 700 mg/m(2), with 500 mg/m(2) being the most convenient and feasible dose for future studies.",2010,"Trough levels for the 500, 600 mg/m(2) and standard weekly regimens were comparable. ","['patients with metastatic colorectal cancer', 'Sixty-two patients were included in the study']","['Cetuximab', 'cetuximab', 'irinotecan plus infusional 5-fluorouracil/folinic acid (FOLFIRI']","['Response rates', 'Trough levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",62.0,0.0150597,"Trough levels for the 500, 600 mg/m(2) and standard weekly regimens were comparable. ","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Medical Oncology Service, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: jtabernero@vhebron.net.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': ""Division of Medical Oncology, Department of Experimental and Clinical Medicine 'F. Magrassi and A. Lanzara', Second University of Naples, Naples, Italy.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rodriguez-Braun', 'Affiliation': 'Department of Hematology and Medical Oncology, Hospital Clinico Universitario, University of Valencia, Spain.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Ramos', 'Affiliation': ""Medical Oncology Service, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martinelli', 'Affiliation': ""Division of Medical Oncology, Department of Experimental and Clinical Medicine 'F. Magrassi and A. Lanzara', Second University of Naples, Naples, Italy.""}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Vega-Villegas', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Roselló', 'Affiliation': 'Department of Hematology and Medical Oncology, Hospital Clinico Universitario, University of Valencia, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Liebscher', 'Affiliation': 'Global Biostatistics.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Kisker', 'Affiliation': 'Medical Sciences Oncology, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Medical Oncology Service, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ""Medical Oncology Service, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': 'Department of Hematology and Medical Oncology, Hospital Clinico Universitario, University of Valencia, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp549'] 3283,19815651,Randomized phase II trial of weekly paclitaxel combined with carboplatin versus standard paclitaxel combined with carboplatin for elderly patients with advanced non-small-cell lung cancer.,"BACKGROUND The optimal platinum doublet regimen in elderly patients with non-small-cell lung cancer (NSCLC) is still uncertain. We conducted a randomized phase II study to compare the efficacy and safety of weekly paclitaxel combined with carboplatin with those of the standard schedule. PATIENTS AND METHODS Elderly patients (age > or =70 years) with advanced NSCLC were randomly assigned to either the weekly arm {70 mg/m(2) paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1} or the standard arm [200 mg/m(2) paclitaxel and carboplatin (AUC = 6) on day 1]. The primary end point was the overall response rate (ORR). RESULTS Eighty-two patients were enrolled. The ORR and median progression-free survival were 55% and 6.0 months for the weekly arm and 53% and 5.6 months for the standard arm. Grade 3/4 neutropenia and peripheral neuropathy were observed in 41% and 0% of the patients in the weekly arm and in 88% and 25% in the standard arm, respectively. CONCLUSIONS This is the first randomized study that compares the platinum doublet designed specifically for the elderly. Regarding the safety, the weekly regimen was less toxic than the standard regimen and seems to be preferable for elderly patients with advanced NSCLC.",2010,"Grade 3/4 neutropenia and peripheral neuropathy were observed in 41% and 0% of the patients in the weekly arm and in 88% and 25% in the standard arm, respectively. ","['elderly patients with non-small-cell lung cancer (NSCLC', 'elderly patients with advanced non-small-cell lung cancer', 'Elderly patients (age > or =70 years) with advanced NSCLC', 'Eighty-two patients were enrolled', 'elderly patients with advanced NSCLC']","['70 mg/m(2) paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1} or the standard arm [200 mg/m(2) paclitaxel and carboplatin', 'paclitaxel combined with carboplatin versus standard paclitaxel combined with carboplatin', 'paclitaxel combined with carboplatin']","['Grade 3/4 neutropenia and peripheral neuropathy', 'efficacy and safety', 'ORR and median progression-free survival', 'overall response rate (ORR']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",82.0,0.0461283,"Grade 3/4 neutropenia and peripheral neuropathy were observed in 41% and 0% of the patients in the weekly arm and in 88% and 25% in the standard arm, respectively. ","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sakakibara', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital. Electronic address: sakatomo@idac.tohoku.ac.jp.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Respiratory Medicine, Sendai Kousei Hospital, Sendai.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Department of Respiratory Medicine, Fukushima Medical University Hospital, Fukushima.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Usui', 'Affiliation': 'Department of Respiratory Medicine, Kanto Medical Center NTT EC, Shinagawa-ku, Tokyo.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Respiratory Medicine, Tohoku Kouseinenkin Hospital, Sendai.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kanbe', 'Affiliation': 'Department of Respiratory Medicine, Senseki Hospital, Higashimatsushima, Yamoto.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Respiratory Medicine, Saka General Hospital, Shiogama.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saijo', 'Affiliation': 'Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp401'] 3284,20019087,Development of a new G-CSF product based on biosimilarity assessment.,"BACKGROUND Zarzio, a new recombinant human granulocyte colony-stimulating factor (filgrastim), was evaluated in healthy volunteers and neutropenic patients in phase I and III studies. PATIENTS AND METHODS Healthy volunteers in randomized, two-period crossover studies received single- and multiple-dose s.c. injections of 1 microg/kg (n = 24), 2.5 microg/kg (n = 28), 5 microg/kg (n = 28), or 10 microg/kg (n = 40), as well as single-dose i.v. infusions of 5 microg/kg (n = 26), of Zarzio or the reference product (Neupogen). Filgrastim serum levels were monitored; pharmacodynamic parameters were absolute neutrophil count (all studies) and CD34(+) cells (multiple-dose studies). Supportive efficacy and safety data were obtained from an open phase III study in 170 breast cancer patients undergoing four cycles of doxorubicin and docetaxel (Taxotere) chemotherapy, receiving Zarzio (300 or 480 microg) as primary prophylaxis of severe neutropenia. RESULTS The results of the studies in healthy volunteers confirm the comparability of the test and reference products with respect to their pharmacodynamics and pharmacokinetics. Confidence intervals were within the predefined equivalence boundaries. In the phase III study in breast cancer patients, the administration of Zarzio was efficacious and safe, triggering no immunogenicity. CONCLUSION The results of these studies demonstrate the biosimilarity of Zarzio with its reference product Neupogen.",2010,"In the phase III study in breast cancer patients, the administration of Zarzio was efficacious and safe, triggering no immunogenicity. ","['170 breast cancer patients undergoing four cycles of', 'Healthy volunteers', 'healthy volunteers', 'breast cancer patients', '300 or 480 microg) as primary prophylaxis of severe neutropenia', 'healthy volunteers and neutropenic patients in phase I and III studies']","['recombinant human granulocyte colony-stimulating factor (filgrastim', 'doxorubicin and docetaxel (Taxotere) chemotherapy, receiving Zarzio', 'Zarzio']","['Filgrastim serum levels', 'neutrophil count (all studies) and CD34(+) cells', 'Supportive efficacy and safety data']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",170.0,0.037007,"In the phase III study in breast cancer patients, the administration of Zarzio was efficacious and safe, triggering no immunogenicity. ","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gascon', 'Affiliation': 'Division of Medical Oncology, Hospital Clinic, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Fuhr', 'Affiliation': 'Department of Pharmacology, University Hospital, University of Cologne, Cologne, Germany; Itecra GmbH & Co. KG, Cologne, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sörgel', 'Affiliation': 'IBMP - Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany; Department of Pharmacology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kinzig-Schippers', 'Affiliation': 'IBMP - Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makhson', 'Affiliation': 'Moscow City Oncology Hospital, Moscow, Russia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Balser', 'Affiliation': 'Sandoz International GmbH, Holzkirchen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Einmahl', 'Affiliation': 'Triskel Integrated Services, Geneva, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Muenzberg', 'Affiliation': 'Sandoz International GmbH, Holzkirchen, Germany. Electronic address: michael.muenzberg@sandoz.com.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp574'] 3285,20032123,"Concomitant chemoradiotherapy versus induction docetaxel, cisplatin and 5 fluorouracil (TPF) followed by concomitant chemoradiotherapy in locally advanced head and neck cancer: a phase II randomized study.","BACKGROUND Concomitant chemoradiotherapy (CT/RT) is the standard treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). We evaluated the efficacy of induction docetaxel (Taxotere), cisplatin, and 5-fluorouracil (TPF) before CT/RT versus CT/RT alone. PATIENTS AND METHODS Patients with stage III-IVM0 SCCHN, Eastern Cooperative Oncology Group performance status of zero to one, were randomly assigned to receive CT/RT alone (arm A: two cycles of cisplatin 20 mg/m(2), days1-4, plus 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, during weeks 1 and 6 of radiotherapy) or three cycles of TPF (arm B: docetaxel 75 mg/m(2) and cisplatin 80 mg/m(2), day 1, and 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, every 3 weeks) followed by the same CT/RT. The primary end point was the rate of radiologic complete response (CR) at 6-8 weeks after the end of CT/RT. RESULTS A total of 101 patients were randomly allocated to the study (51 arm A; 50 arm B). CR rates were 21.2% (arm A) versus 50% (arm B). Median progression-free survival and overall survival were, respectively, 19.7 and 33.3 months (arm A) and 30.4 and 39.6 months (arm B). Hematologic and non-hematologic toxic effects during CT/RT were similar in the two arms. CONCLUSION Induction TPF followed by CT/RT was associated with higher radiologic CR in patients with locally advanced SCCHN with no negative impact on CT/RT feasibility.",2010,"Median progression-free survival and overall survival were, respectively, 19.7 and 33.3 months (arm A) and 30.4 and 39.6 months (arm B).","['A total of 101 patients', 'locally advanced squamous cell carcinoma of the head and neck (SCCHN', 'locally advanced head and neck cancer', 'Patients with stage III-IVM0 SCCHN, Eastern Cooperative Oncology Group performance status of zero to one']","['cisplatin 20 mg/m(2), days1-4, plus 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, during weeks 1 and 6 of radiotherapy', 'Concomitant chemoradiotherapy versus induction docetaxel, cisplatin and 5 fluorouracil (TPF) followed by concomitant chemoradiotherapy', 'TPF (arm B: docetaxel 75 mg/m(2) and cisplatin 80 mg/m(2), day 1, and 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion, every 3 weeks) followed by the same CT/RT', 'induction docetaxel (Taxotere), cisplatin, and 5-fluorouracil (TPF) before CT/RT versus CT/RT alone', 'CT/RT alone', 'Concomitant chemoradiotherapy (CT/RT']","['CR rates', 'Median progression-free survival and overall survival', 'Hematologic and non-hematologic toxic effects', 'rate of radiologic complete response (CR']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",101.0,0.0529432,"Median progression-free survival and overall survival were, respectively, 19.7 and 33.3 months (arm A) and 30.4 and 39.6 months (arm B).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paccagnella', 'Affiliation': 'Department of Medical Oncology, Venezia. Electronic address: adriano.paccagnella@ulss12.ve.it.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Ghi', 'Affiliation': 'Department of Medical Oncology, Venezia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Loreggian', 'Affiliation': 'Department of Radiotherapy, Istituto Oncologico Veneto, Istituto di Ricerca e Cura a Carattere Scientifico, Padova.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Buffoli', 'Affiliation': 'Department of Radiotherapy, Azienda Ospedaliera Universitaria, Udine.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Koussis', 'Affiliation': 'Department of Medical Oncology, Istituto Oncologico Veneto, IRCCS, Padova.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Mione', 'Affiliation': 'Department of Radiotherapy, Ospedale SS. Giovanni e Paolo, Venezia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bonetti', 'Affiliation': 'Department of Medical Oncology, Ospedale Mater Salutis, Legnago.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Campostrini', 'Affiliation': 'Department of Radiotherapy, Ospedale Mater Salutis, Legnago.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gardani', 'Affiliation': 'Department of Radiotherapy, S. Gerardo Hospital, Monza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ardizzoia', 'Affiliation': 'Department of Medical Oncology, S. Gerardo Hospital, Monza.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dondi', 'Affiliation': 'Sanofi-Aventis, Milano.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guaraldi', 'Affiliation': 'Department of Medical Oncology, S. Orsola-Malpighi Hospital, Bologna.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cavallo', 'Affiliation': 'Department of Medical Oncology, P. Cosma Hospital, Camposampiero, Padova.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tomio', 'Affiliation': 'Department of Radiotherapy, S. Chiara Hospital, Trento.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gava', 'Affiliation': ""Department of Radiotherapy, Ospedale Ca' Foncello, Treviso, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp573'] 3286,20139154,From randomized trial to practice: single institution experience using the GOG 172 i.p. chemotherapy regimen for ovarian cancer.,"BACKGROUND The objective of the study was to evaluate completion rates and toxic effects of an i.p. chemotherapy regimen in a cross-section of nonselected patients with ovarian cancer (OC). PATIENTS AND METHODS All patients with stage IIIC OC consecutively operated at our institution from January 2006 to December 2007 were prospectively collected and analyzed. RESULTS Eighty-nine patients with stage IIIC OC optimally debulked were evaluated for this study. An i.p. port was primarily placed in 53 of 89 (60%), and i.p. chemotherapy was recommended in 55 patients. Reasons for not recommending i.p. chemotherapy in patients optimally debulked included postoperative complications (n = 7: 8%), poor nutritional/functional status (n = 5: 6%), and extensive surgery including bowel resection (n = 9: 10%). Thirty-three patients (33/55: 60%) recommended to receive i.p. chemotherapy-initiated i.p. treatment. Fifty-two percent of those beginning i.p. therapy (17/33) received three or more cycles with 36% (12/33) successfully completing six cycles. Reasons for discontinuation included grade 3-4 nephrotoxicity in 3 of 21 (14%), febrile neutropenia/sepsis in 3 of 21 (14%), port infection or malfunction in 8 of 21 (38%). CONCLUSIONS The i.p. chemotherapy regimen used in a consecutive cohort of patients carries could be completed in only a small percentage of patients. Less toxic regimens with higher acceptability should be considered.",2010,therapy (17/33) received three or more cycles with 36% (12/33) successfully completing six cycles.,"['55 patients', 'ovarian cancer', 'Eighty-nine patients with stage IIIC OC optimally debulked', 'nonselected patients with ovarian cancer (OC', 'patients optimally debulked included postoperative complications (n = 7: 8%), poor nutritional/functional status (n = 5: 6%), and extensive surgery including bowel resection (n = 9: 10', 'All patients with stage IIIC OC consecutively operated at our institution from January 2006 to December 2007 were prospectively collected and analyzed']","['chemotherapy regimen', 'chemotherapy', 'chemotherapy-initiated i.p']","['completion rates and toxic effects', 'febrile neutropenia/sepsis', 'port infection or malfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C (qualifier value)'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",89.0,0.0236312,therapy (17/33) received three or more cycles with 36% (12/33) successfully completing six cycles.,"[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Aletti', 'Affiliation': 'Department of Gynecologic Surgery, Rochester, MN, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nordquist', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hartmann', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gallenberg', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Long', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Cliby', 'Affiliation': 'Department of Gynecologic Surgery, Rochester, MN, USA. Electronic address: cliby.william@mayo.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq025'] 3287,19815652,"Preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) improves prognosis in locally advanced breast cancer patients: an update of the Southern Italy Cooperative Oncology Group (SICOG) randomised trial 9908.","BACKGROUND The present article reports the updated survival outcome of the 200 patients enrolled in the Southern Italy Cooperative Oncology Group 9908 trial, which compared 12 weekly cycles of cisplatin-epirubicin-paclitaxel (PET) with 4 triweekly (once every 3 weeks) cycles of epirubicin-paclitaxel (ET) in patients with locally advanced breast cancer (LABC). METHODS The effects of treatment, pathologically documented response (pathological response), pre- and post-treatment biomarkers on relapse-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS) are analysed. RESULTS At a median follow-up of 74 (range 48-105 months) months, the 5-year RFS, DMFS, and OS were 64 % versus 53% (P = 0.11), 73% versus 55% (P = 0.04), and 82% versus 69% (P = 0.07) in PET and ET, respectively. At multivariate analysis, after adjusting treatment effect for pretreatment biomarkers, PET independently predicted better DMFS (P = 0.018) and OS (P = 0.03), whereas the impact on RFS was of borderline significance (0.057). PET treatment was significantly better than ET treatment only in high-grade or highly proliferating tumours. The better outcome in PET arm was the results of both the higher rate of patients with optimal pathological response and the lower rate of patients with biologically aggressive residual tumour. CONCLUSIONS The PET weekly regimen significantly improves both DMFS and OS in LABC patients, compared with the triweekly ET combination. The therapeutic advantage is limited to patients with highly aggressive tumours.",2010,PET treatment was significantly better than ET treatment only in high-grade or highly proliferating tumours.,"['locally advanced breast cancer patients', 'patients with locally advanced breast cancer (LABC', '200 patients enrolled in the Southern Italy Cooperative Oncology Group 9908 trial', 'patients with highly aggressive tumours']","['Preoperative weekly cisplatin, epirubicin, and paclitaxel (PET', 'epirubicin-paclitaxel (ET', 'cisplatin-epirubicin-paclitaxel (PET', 'PET']","['relapse-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS', '5-year RFS, DMFS, and OS', 'DMFS and OS']","[{'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",200.0,0.149215,PET treatment was significantly better than ET treatment only in high-grade or highly proliferating tumours.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Frasci', 'Affiliation': 'Department of Senology. Electronic address: giuseppe.frasci@libero.it.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': ""D'Aiuto"", 'Affiliation': 'Department of Senology.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Comella', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""D'Aiuto"", 'Affiliation': 'Department of Senology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Bonito', 'Affiliation': 'Department of Pathology.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ruffolo', 'Affiliation': 'Department of Senology.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iodice', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Petrillo', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lastoria', 'Affiliation': 'Department of Nuclear Medicine.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Oliviero', 'Affiliation': 'Department of Senology.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Capasso', 'Affiliation': 'Department of Senology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montella', 'Affiliation': 'Department of Epidemiology, National Cancer Institute, Naples.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Siani', 'Affiliation': ""Department of Surgery, Faculty of Medicine, University 'Magna Grecia' of Catanzaro, Catanzaro.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santangelo', 'Affiliation': 'Department of Surgical and Anaesthesiological Sciences, Faculty of Medicine, University Federico II, Naples, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vizioli', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroimaging, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Comella', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp356'] 3288,20038515,Cost-effectiveness of adjuvant docetaxel for node-positive breast cancer patients: results of the PACS 01 economic study.,"BACKGROUND Using data from the PACS 01 randomized trial, we evaluated the cost-effectiveness of anthracyclines plus docetaxel (Taxotere; FEC-D) versus anthracyclines alone (FEC100) in patients with node-positive breast cancer. PATIENTS AND METHODS Costs and outcomes were assessed in 1996 patients and the incremental cost-effectiveness ratios (ICERs) were estimated, using quality-adjusted life years (QALYs) as outcome. To deal with uncertainty due to sampling fluctuations, confidence regions around the ICERs were calculated and cost-effectiveness acceptability curves were drawn up. Sensitivity analyses were also carried out to assess the robustness of conclusions. RESULTS The mean cost of treatment was 33% higher with strategy FEC-D, but this difference decreased to 18% at a 5-year horizon. The ICER of FEC-D versus FEC100 was estimated to be 9665euro per QALY gained (95% confidence interval euro2372-euro55 515). The estimated probability that FEC-D was cost-effective reached >96% for a threshold of euro50 000 per QALY gained. If the price of taxane decreased slightly, the ICER would reach some very reasonable levels and this strategy would therefore be much more cost-effective. CONCLUSION The sequential use of FEC100 followed by docetaxel appears to be a cost-effective alternative, even when uncertainty is taken into account.",2010,"The mean cost of treatment was 33% higher with strategy FEC-D, but this difference decreased to 18% at a 5-year horizon.","['1996 patients and the', 'node-positive breast cancer patients', 'patients with node-positive breast cancer']","['anthracyclines plus docetaxel (Taxotere; FEC-D) versus anthracyclines alone (FEC100', 'FEC100 followed by docetaxel', 'adjuvant docetaxel', 'taxane']","['incremental cost-effectiveness ratios (ICERs', 'ICER of FEC-D versus FEC100', 'mean cost of treatment', 'Cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",1996.0,0.031188,"The mean cost of treatment was 33% higher with strategy FEC-D, but this difference decreased to 18% at a 5-year horizon.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marino', 'Affiliation': 'Institut National pour la Santé et la Recherche médicale, unité 912, Marseille; Aix-Marseille Université, Marseille. Electronic address: patricia.marino@inserm.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Siani', 'Affiliation': 'Research Center in Knowledge Engineering (ERIC, EA3083), University of Lyon (University Claude Bernard Lyon 1), Lyon.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roché', 'Affiliation': 'Institut Claudius Régaud, Toulouse.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Protière', 'Affiliation': 'Institut National pour la Santé et la Recherche médicale, unité 912, Marseille; Aix-Marseille Université, Marseille.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fumoleau', 'Affiliation': 'Centre Georges-François Leclerc, Dijon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spielmann', 'Affiliation': 'Institut Gustave Roussy, Villejuif.'}, {'ForeName': 'A-L', 'Initials': 'AL', 'LastName': 'Martin', 'Affiliation': 'Fédération Nationale des Centres de Lutte Contre le Cancer, Paris.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Viens', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'A-G', 'Initials': 'AG', 'LastName': 'Le Corroller Soriano', 'Affiliation': 'Institut National pour la Santé et la Recherche médicale, unité 912, Marseille; Aix-Marseille Université, Marseille.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp561'] 3289,20157180,"Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma.","BACKGROUND Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. DESIGN AND METHODS Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m(2) (n = 15); cohort B, 375 mg/m(2) (n = 16); cohort C, first dose 375 mg/m(2), seven subsequent doses of 750 mg/m(2) (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. RESULTS The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1-6) prior regimens. Ocrelizumab was well tolerated with grade 3/4 toxicity occurring in 9% of patients. The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event. The objective response rate was 38% and was similar in patients with low-affinity and high-affinity variants of the Fcgamma receptor IIIa (FcgammaRIIIa). With follow-up of approximately 28 months, the median progression-free survival was 11.4 months. CONCLUSION Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder.",2010,"The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event.","['patients with relapsed/refractory follicular lymphoma', 'Forty-seven patients', 'The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1-6) prior regimens', 'patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy']","['ocrelizumab', 'Ocrelizumab']","['median progression-free survival', 'objective response rate', 'safety and efficacy', 'safety, efficacy, pharmacodynamics and pharmacokinetics', 'tolerated with grade 3/4 toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4047978', 'cui_str': 'Rituximab therapy'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",47.0,0.0240511,"The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'Department of Hematology, Claude Huriez Hospital, Lille, France. Electronic address: franck.morschhauser@chru-lille.fr.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marlton', 'Affiliation': 'Department of Clinical Hematology and Medical Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Department of Hematology, San Giovanni Battista Hospital, Turin, Italy.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Lindén', 'Affiliation': 'Department of Oncology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Department of Hematology and Medical Oncology, Peter MacCallum Cancer Institute and University of Melbourne, Victoria, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Crump', 'Affiliation': 'Department of Medical Oncology, Princess Margaret Hospital, Toronto, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': 'Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre Bénite, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Foà', 'Affiliation': ""Department of Cellular Biotechnologies and Hematology, 'Sapienza University', Rome, Italy.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wassner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'H-U', 'Initials': 'HU', 'LastName': 'Burger', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mendila', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq027'] 3290,19474112,Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial.,"BACKGROUND To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial. METHODS We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment. RESULTS The incidence of bone fractures was higher among patients treated with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone fracture, and previous hormone replacement therapy. CONCLUSIONS Consistent with other trials comparing aromatase inhibitors to tamoxifen, letrozole was associated with an increase in bone fractures. Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients.",2009,The wrist was the most common site of fracture in both treatment groups.,"['postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of', 'postmenopausal women treated with 5 years of adjuvant', '4895 patients allocated to 5 years of', 'for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial']","['tamoxifen', 'tamoxifen or letrozole', 'letrozole', 'letrozole or tamoxifen', 'tamoxifen, letrozole']","['Bone fractures', 'Bone fracture information (grade, cause, site', 'bone fractures', 'incidence of bone fractures']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",4895.0,0.0679758,The wrist was the most common site of fracture in both treatment groups.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Center and Inselspital, Bern, Switzerland. Electronic address: manuela.rabaglio@ibcsg.org.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'IBCSG Coordinating Center, Bern.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hawle', 'Affiliation': 'IBCSG Coordinating Center, Bern.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Senology Center of Eastern Switzerland and Swiss Group for Clinical Cancer Research (SAKK), Kantonsspital, St Gallen, Switzerland, Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mouridsen', 'Affiliation': 'Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'Institut du Cancer Nantes Atlantique, CLCC René Gauducheau, Saint Herblain, Fédération Nationale des Centres de Lutte Contre le Cancer, France.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Forbes', 'Affiliation': 'Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Paridaens', 'Affiliation': 'Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pienkowski', 'Affiliation': 'Cancer Center Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Nogaret', 'Affiliation': 'Department of Mammary and Pelvic Surgery, Jules Bordet Institute; Brussels, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Breast Unit, The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Department of Medicine, European Institute of Oncology, Milan, Italy; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp033'] 3291,20007996,Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support.,"BACKGROUND American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC. PATIENTS AND METHODS Eighty patients were assigned to FIL at a daily dose of 5 mug/kg or a single fixed dose of PEG (6 mg) 1 day after PBSC. The primary end point was the duration of neutropenia both in terms of absolute neutrophil count (ANC) <0.5 x 10(9)/l and of days to reach an ANC >0.5 x 10(9)/l. RESULTS The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC >0.5 x 10(9)/l was 11.5 and 10.8 in the FIL and PEG group, respectively. No differences were observed in the mean time to reach an ANC >1.0 x 10(9)/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%). The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group, respectively. CONCLUSION PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.",2010,No differences were observed in the mean time to reach an ANC >1.0 x 10(9)/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%).,['Eighty patients'],"['Pegfilgrastim versus filgrastim', 'FIL', 'filgrastim (FIL', 'pegfilgrastim (PEG', 'PEG']","['incidence of fever', 'duration of neutropenia both in terms of absolute neutrophil count (ANC', 'mean duration of antibiotic therapy', 'mean time to reach an ANC', 'mean duration of neutropenia']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",80.0,0.0634582,No differences were observed in the mean time to reach an ANC >1.0 x 10(9)/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%).,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Castagna', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bramanti', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan. Electronic address: stefania.bramanti@humanitas.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Levis', 'Affiliation': 'Division of Hematology, Ospedale SS Antonio e Biagio, Alessandria.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Michieli', 'Affiliation': 'Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anastasia', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mazza', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Giordano', 'Affiliation': 'Statistic Unit, Istituto Clinico Humanitas, Rozzano, Milan, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sarina', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Todisco', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.'}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Gregorini', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp576'] 3292,20019086,Economic evaluation of docetaxel-gemcitabine versus vinorelbine-cisplatin combination as front-line treatment of patients with advanced/metastatic non-small-cell lung cancer in Greece: a cost-minimization analysis.,"BACKGROUND An economic evaluation was undertaken, alongside a randomized phase III study, to assess docetaxel-gemcitabine (DG) relative to vinorelbine-cisplatin (VC) combination as front-line treatment of patients with advanced/metastatic non-small-cell lung cancer. METHODS No differences were found in efficacy, thus a cost-minimization analysis was carried out. Treatment cost accounts for the administration of first- and second-line chemotherapy, for concomitant medications, for laboratory and biochemical examinations, and for hospitalizations due to adverse events. Unit prices used reflect 2008 and are common among National Health Service hospitals in Greece. RESULTS The mean total cost of therapy in the DG group [14045 euros, 95% uncertainty interval (UI) 12628 euros-15390 euros], was significantly higher than in the VC group (8143 euros, 95% UI 7314 euros-9067 euros). CONCLUSIONS Even though the combination VC has similar effectiveness compared with DG in patients with metastatic lung cancer, it is associated with a lower overall treatment cost and hence, it is preferable from an economic perspective. However, it should be noted that although VC is associated with lower cost, it is also more toxic than DG regimen, a significant parameter that should be considered in clinical decisions.",2010,"The mean total cost of therapy in the DG group [14045 euros, 95% uncertainty interval (UI) 12628 euros-15390 euros], was significantly higher than in the VC group (8143 euros, 95% UI 7314 euros-9067 euros). ","['patients with advanced/metastatic non-small-cell lung cancer in Greece', 'National Health Service hospitals in Greece', 'patients with advanced/metastatic non-small-cell lung cancer', 'patients with metastatic lung cancer']","['first- and second-line chemotherapy', 'docetaxel-gemcitabine versus vinorelbine-cisplatin combination', 'docetaxel-gemcitabine (DG) relative to vinorelbine-cisplatin (VC) combination']",['mean total cost of therapy'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0443681,"The mean total cost of therapy in the DG group [14045 euros, 95% uncertainty interval (UI) 12628 euros-15390 euros], was significantly higher than in the VC group (8143 euros, 95% UI 7314 euros-9067 euros). ","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Maniadakis', 'Affiliation': 'Department of Health Services Management, National School of Public Health, Athens. Electronic address: nmaniadakis@nsph.gr.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Fragoulakis', 'Affiliation': 'Department of Health Services Management, National School of Public Health, Athens.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Pallis', 'Affiliation': 'Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simou', 'Affiliation': 'Department of Health Services Management, National School of Public Health, Athens.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Greece.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp551'] 3293,20089562,Epirubicin and cyclophosphamide versus epirubicin and docetaxel as first-line therapy for women with metastatic breast cancer: final results of a randomised phase III trial.,"BACKGROUND This randomised phase III trial was carried out to compare the efficacy and safety of epirubicin and cyclophosphamide (EC) with epirubicin and docetaxel (Taxotere) (ED) as first-line chemotherapy for metastatic breast cancer. PATIENTS AND METHODS Patients (n = 240) were randomly assigned to receive either ED (epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2)) or EC (epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)). The primary end point was objective response rate (ORR). Secondary end points were progression-free survival (PFS), overall survival (OS), and safety. RESULTS ORR for patients randomly assigned to receive EC and ED were 42% and 47%, respectively (P = 0.63). Median PFS [10.1 versus 10.3 months; hazard ratio (HR) 0.98; log-rank P = 0.38] and OS (19.9 versus 30.0 months; HR 0.663; log-rank P = 0.21) were comparable in both arms. Although grade 3/4 leucopenia occurred more frequently with ED (81% versus 73%; P = 0.01), there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections. Grade 3/4 non-haematologic toxicity was infrequent in both arms. Congestive heart failure was observed in one patient in each arm. CONCLUSION In this randomised trial, no differences in the efficacy study end points were observed between the two treatment arms.",2010,"Although grade 3/4 leucopenia occurred more frequently with ED (81% versus 73%; P = 0.01), there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections.","['women with metastatic breast cancer', 'metastatic breast cancer', 'Patients (n = 240']","['ED (epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2)) or EC (epirubicin 90 mg/m(2) and cyclophosphamide', 'Epirubicin and cyclophosphamide versus epirubicin and docetaxel', 'epirubicin and cyclophosphamide (EC) with epirubicin and docetaxel', 'Taxotere) (ED']","['progression-free survival (PFS), overall survival (OS), and safety', 'Median PFS ', 'efficacy and safety', 'objective response rate (ORR', 'Congestive heart failure', 'febrile neutropenia and grade 3/4 infections', 'Grade 3/4 non-haematologic toxicity', 'grade 3/4 leucopenia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",240.0,0.145365,"Although grade 3/4 leucopenia occurred more frequently with ED (81% versus 73%; P = 0.01), there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections.","[{'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Department of Gynaecology and Obstetrics, Campus Charité Mitte, Charité University Hospital; Department of Gynaecology and Obstetrics, Sankt Gertrauden-Krankenhaus, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Department of Medical Oncology, Charing Cross Hospital, Imperial College London, London, UK. Electronic address: p.schmid@imperial.ac.uk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hilfrich', 'Affiliation': 'Department of Gynaecology and Obstetrics, Henriettenstift, Hannover.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Friese', 'Affiliation': 'Department of Gynaecology and Obstetrics, Ludwig-Maximilians University, München; Department of Gynaecology and Obstetrics, University of Rostock, Rostock.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kleine-Tebbe', 'Affiliation': 'Department of Gynaecology and Obstetrics, Charité Campus Virchow Klinikum, Charité University Hospital, Berlin.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Koelbl', 'Affiliation': 'Department of Gynaecology and Obstetrics, Martin-Luther University Halle-Wittenberg, Halle.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sommer', 'Affiliation': 'Department of Gynaecology and Obstetrics, Ludwig-Maximilians University, München.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Morack', 'Affiliation': 'Department of Gynaecology and Obstetrics, Helios Klinikum Berlin-Buch, Berlin.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Wischnewsky', 'Affiliation': 'Department of Biomathematics and Intelligent Systems, University of Bremen, Bremen.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lichtenegger', 'Affiliation': 'Department of Gynaecology and Obstetrics, Campus Charité Mitte, Charité University Hospital; Department of Gynaecology and Obstetrics, Charité Campus Virchow Klinikum, Charité University Hospital, Berlin.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': 'Department of Gynaecology and Obstetrics, Campus Charité Mitte, Charité University Hospital; Breast Unit, Cancer Centre Essen, Kliniken Essen-Mitte, Essen, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp585'] 3294,19713248,Capecitabine in combination with oxaliplatin or irinotecan in elderly patients with advanced colorectal cancer: results of a randomized phase II study.,"BACKGROUND To determine the efficacy and tolerability of capecitabine combined with oxaliplatin (CAPOX) or irinotecan (CAPIRI) as first-line treatment in patients with advanced/metastatic colorectal cancer aged > or =70 years. PATIENTS AND METHODS Patients aged > or =70 years were randomly assigned to receive CAPOX [oxaliplatin 65 mg/m(2) intravenously (i.v.) days 1 and 8 and capecitabine 1000 mg/m(2) orally b.i.d. days 1-14; q21d] or CAPIRI (irinotecan 80 mg/m(2) i.v. days 1 and 8 and capecitabine 1000 mg/m(2) orally b.i.d. days 1-14; q21d). The primary study end point was overall response rate (ORR). RESULTS Ninety-four patients were enrolled. In an intent-to-treat analysis, 2 complete responses (CRs) and 16 partial responses (PRs) were reported with CAPOX (ORR 38%), and 2 CRs and 15 PRs with CAPIRI (ORR 36%; P = 0.831). Median time to progression was 8 months for CAPOX and 7 months for CAPIRI (P = 0.195), with median survival times of 19.3 months and 14.0 months (P = 0.165), respectively. Global health status was improved in 45% and in 21% of patients in the CAPOX and CAPIRI arms, respectively. The most common treatment-related grade 3-4 adverse events in CAPIRI versus CAPOX patients were diarrhea (32% versus 15%; P = 0.052) and neutropenia (23% versus 6%; P = 0.021). CONCLUSION CAPOX and CAPIRI had similar efficacy in elderly patients, although CAPOX seemed to be better tolerated.",2010,"Median time to progression was 8 months for CAPOX and 7 months for CAPIRI (P = 0.195), with median survival times of 19.3 months and 14.0 months (P = 0.165), respectively.","['patients with advanced/metastatic colorectal cancer aged > or =70 years', 'Patients aged > or =70 years', 'elderly patients with advanced colorectal cancer', 'Ninety-four patients were enrolled', 'elderly patients']","['capecitabine combined with oxaliplatin (CAPOX) or irinotecan (CAPIRI', 'capecitabine 1000 mg/m(2) orally b.i.d', 'CAPOX [oxaliplatin 65 mg/m(2) intravenously (i.v.) days 1 and 8 and capecitabine 1000 mg/m(2) orally b.i.d', 'oxaliplatin or irinotecan', 'Capecitabine', 'CAPIRI (irinotecan 80 mg/m(2) i.v']","['overall response rate (ORR', 'complete responses (CRs) and 16 partial responses (PRs', 'Median time to progression', 'tolerated', 'diarrhea', 'neutropenia', 'median survival times', 'efficacy and tolerability', 'Global health status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C3489692', 'cui_str': 'CAPIRI'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",94.0,0.104468,"Median time to progression was 8 months for CAPOX and 7 months for CAPIRI (P = 0.195), with median survival times of 19.3 months and 14.0 months (P = 0.165), respectively.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, S. Carlo Hospital, Potenza. Electronic address: oncogerry@yahoo.it.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cordio', 'Affiliation': 'Medical Oncology Unit, Garibaldi Nesima Hospital.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bordonaro', 'Affiliation': 'Medical Oncology Unit, Vittorio Emanuele Hospital, Catania.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Caputo', 'Affiliation': 'Medical Oncology Unit, Garibaldi Nesima Hospital.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Novello', 'Affiliation': 'Medical Oncology Unit, Vittorio Emanuele Hospital, Catania.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Reggiardo', 'Affiliation': 'Biostatistic Unit Medi Service, Genova, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Manzione', 'Affiliation': 'Medical Oncology Unit, S. Carlo Hospital, Potenza.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp359'] 3295,20497967,"Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as first-line treatment in patients with advanced oesophago-gastric cancer: a randomised, multicentre open-label phase II study.","BACKGROUND Clinical data showed promising antitumour activity with feasible tolerability for matuzumab plus epirubicin, cisplatin and capecitabine (ECX) chemotherapy in untreated advanced oesophago-gastric (OG) cancer. The aim was to evaluate the efficacy of matuzumab plus ECX versus ECX alone. PATIENTS AND METHODS In this multicentre, randomised open-label phase II study, 72 patients with metastatic OG cancer were randomly assigned to either 800 mg matuzumab weekly plus epirubicin 50 mg/m², cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21-day cycle (ECX) or the same ECX regimen alone. The primary end point was objective response. Secondary end points included progression-free survival (PFS), overall survival (OS), quality of life, safety and tolerability. RESULTS Following random assignment, 35 patients (median age 59 years) received ECX/matuzumab and 36 patients (median age 64 years) ECX. The addition of matuzumab to ECX did not improve objective response: 31% for ECX/matuzumab [95% confidence interval (CI) 17-49] compared with 58% for the ECX arm (95% CI 41-74) P = 0.994 (one sided). There was no significant difference in median PFS: 4.8 months (95% CI 2.9-8.1) for ECX/matuzumab versus 7.1 months (95% CI 4.4-8.5) for ECX, or in median OS: 9.4 months (95% CI 7.5-16.2), compared with 12.2 months (95% CI 9.8-13.8 months). Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups, respectively. CONCLUSION Matuzumab 800 mg weekly combined with ECX chemotherapy does not increase response or survival for patients with advanced OG cancer. Therefore, ECX/matuzumab should not be examined further in phase III trials.",2010,"Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups, respectively. ","['and 36 patients (median age 64 years) ECX', '72 patients with metastatic OG cancer', 'patients with advanced oesophago-gastric cancer', '35 patients (median age 59 years) received', 'untreated advanced oesophago-gastric (OG) cancer', 'patients with advanced OG cancer']","['ECX/matuzumab', '800 mg matuzumab weekly plus epirubicin 50 mg/m², cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21-day cycle (ECX) or the same ECX regimen alone', 'Matuzumab plus epirubicin, cisplatin and capecitabine (ECX', 'matuzumab plus ECX', 'ECX', 'matuzumab plus epirubicin, cisplatin and capecitabine (ECX) chemotherapy', 'epirubicin, cisplatin and capecitabine alone', 'Matuzumab 800 mg weekly combined with ECX chemotherapy']","['Grade 3/4 treatment-related toxicity', 'response or survival', 'median PFS', 'objective response', 'progression-free survival (PFS), overall survival (OS), quality of life, safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C1328134', 'cui_str': 'matuzumab'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",72.0,0.198787,"Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups, respectively. ","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Gastrointestinal Unit, Royal Marsden Hospital, London and Surrey, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Gastrointestinal Unit, Royal Marsden Hospital, London and Surrey, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Gastrointestinal Unit, Royal Marsden Hospital, London and Surrey, UK. Electronic address: david.cunningham@rmh.nhs.uk.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sumpter', 'Affiliation': 'Oncology Department, Newcastle General Hospital, Newcastle, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': ""Oncology Department, Addenbrooke's NHS Trust, Cambridge, UK.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Department of Haematology and Oncology, St Gallen, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Valladares-Ayerbes', 'Affiliation': 'Department of Medical Oncology, Complejo Hospitalario Juan Canalejo, A Coruña, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wilke', 'Affiliation': 'Oncology Department, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Archer', 'Affiliation': ""Oncology Department, St Mary's Hospital, Portsmouth, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kurek', 'Affiliation': 'Gastrointestinal Oncology, Merck Serono, Darmstadt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Beadman', 'Affiliation': 'Gastrointestinal Oncology, Merck Serono, Darmstadt, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Oates', 'Affiliation': 'Gastrointestinal Unit, Royal Marsden Hospital, London and Surrey, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq247'] 3296,31568130,The relevance of the individual screening for genetic variants in predicting ovarian response.,"OBJECTIVE To investigate if polymorphisms of some genes involved in folliculogenesis predict ovarian response. METHODS This prospective randomized study includes 124 egg donors genotyped for six SNPs ESR1 (rs2234693), AMHR2 (rs2002555), GDF-9 (rs10491279 and rs254286), AMH (rs10407022) and LHCBR (rs229327) genes and four STRs in ESR1 rs3138774), SHBG (rs6761), CYP19A1 (rs60271534) and AR genes (CAG repeats in exon 1). All donors followed standard ovarian stimulation protocol using a daily dose of 225 UI. The genotypes obtained were compared with the ovarian stimulation outcome. RESULTS Regarding the number of retrieved oocytes, we found statistical differences for the ESR1 SNP and STR (19.3 ± 8.9 for TT vs 15.3 ± 6.2 for CC/CT, P = 0.027; 19.1 ± 8.3 for <17repeats vs 14.7 ± 6.2 for >17repeats, P = 0.020). Moreover, women carrying TT in the ESR1 at position c.-397T>C with ESR1 (TA)n=17 retrieved the highest number of oocytes (20.4 ± 9.3) (P = 0.001). Concerning AMHR2, we observed an association with the length of stimulation (9.1 ± 1.4 d for AA vs 9.7 ± 1.3 d for AG/GG, P = 0.021) and gonadotropin received (2050 ± 319 for AA vs 2188 ± 299 for AG/GG, P = 0.017). No significant differences were observed for the other polymorphisms (P > 0.05). CONCLUSION The polymorphisms in ESR1 and AMHR2 genes showed a clear association with the number of retrieved oocytes and the stimulation data, respectively. Our results suggest that polymorphisms in the genes for key reproductive hormones receptors could be used to predict the ovarian response and to personalize the stimulation prior the treatment.",2019,"The polymorphisms in ESR1 and AMHR2 genes showed a clear association with the number of retrieved oocytes and the stimulation data, respectively.",['124 egg donors genotyped for six'],[],"['SNPs ESR1 (rs2234693), AMHR2 (rs2002555), GDF-9 (rs10491279 and rs254286), AMH (rs10407022) and LHCBR (rs229327) genes and four STRs in ESR1 rs3138774), SHBG (rs6761), CYP19A1 (rs60271534) and AR genes (CAG repeats']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0029975', 'cui_str': 'Ovum Donors'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]",[],"[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0213144', 'cui_str': 'GDF-9'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0003805', 'cui_str': 'CYP19 Protein'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]",225.0,0.0578664,"The polymorphisms in ESR1 and AMHR2 genes showed a clear association with the number of retrieved oocytes and the stimulation data, respectively.","[{'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Lledó', 'Affiliation': 'Molecular Biology, Instituto Bernabeu Biotech.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Llácer', 'Affiliation': 'Reproductive Medicine, Instituto Bernabeu of Fertility and Gynecology, Alicante, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Blanco', 'Affiliation': 'Molecular Biology, Instituto Bernabeu Biotech.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Ortiz', 'Affiliation': 'Molecular Biology, Instituto Bernabeu Biotech.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Morales', 'Affiliation': 'Molecular Biology, Instituto Bernabeu Biotech.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fabregat', 'Affiliation': 'Molecular Biology, Instituto Bernabeu Biotech.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Guerrero', 'Affiliation': 'Reproductive Medicine, Instituto Bernabeu of Fertility and Gynecology, Alicante, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Bernabeu', 'Affiliation': 'Molecular Biology, Instituto Bernabeu Biotech.'}]",Pharmacogenetics and genomics,['10.1097/FPC.0000000000000386'] 3297,20444845,Efficacy of zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36-month results of the ZO-FAST Study.,"BACKGROUND Aromatase inhibitors (AIs) are accepted as adjuvant therapy for postmenopausal women (PMW) with hormone-responsive early breast cancer (EBC) with superior efficacy to tamoxifen. However, increased bone loss is associated with AIs. PATIENTS AND METHODS PMW with EBC receiving letrozole (2.5 mg/day for 5 years) were randomly assigned to immediate zoledronic acid (ZOL; 4 mg every 6 months) or delayed ZOL (initiated only for fracture or high risk thereof). RESULTS Patients (N = 1065) had a median age of 58 years; 54% had received prior adjuvant chemotherapy. At 36 months, mean change in L2-L4 bone mineral density (BMD) was +4.39% for immediate versus -4.9% for delayed ZOL (P < 0.0001). Between-group differences were 5.27% at 12 months, 7.94% at 24 months, and 9.29% at 36 months (P < 0.0001 for all). At 36 months, the immediate-ZOL group had a significant 41% relative risk reduction for disease-free survival (DFS) events (P = 0.0314). Adverse events are consistent with the known safety profiles of the study drugs. CONCLUSIONS At 36 months, immediate ZOL was more effective in preserving BMD during letrozole therapy. Immediate versus delayed ZOL led to significantly improved DFS. Benefits are observed in the context of a favorable, well-established safety profile for letrozole and ZOL.",2010,"At 36 months, the immediate-ZOL group had a significant 41% relative risk reduction for disease-free survival (DFS) events (P = 0.0314).","['postmenopausal women (PMW) with hormone-responsive early breast cancer (EBC', 'PMW with EBC receiving', 'postmenopausal women with early breast cancer receiving adjuvant', '2.5 mg/day for 5 years', 'Patients (N = 1065) had a median age of 58 years; 54% had received prior adjuvant chemotherapy']","['tamoxifen', 'delayed ZOL', 'letrozole', 'zoledronic acid', 'immediate zoledronic acid (ZOL; 4 mg every 6 months) or delayed ZOL (initiated only for fracture or high risk thereof']","['bone loss', 'disease-free survival (DFS) events', 'DFS', 'L2-L4 bone mineral density (BMD']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0585339', 'cui_str': 'q6mo'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",1065.0,0.026552,"At 36 months, the immediate-ZOL group had a significant 41% relative risk reduction for disease-free survival (DFS) events (P = 0.0314).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eidtmann', 'Affiliation': 'Klinik für Gynäkologie und Geburtshilfe, Universitäts Frauenklinik Kiel, Germany. Electronic address: eidtmann@email.uni-kiel.de.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Boer', 'Affiliation': 'Medical Oncology, Royal Melbourne Hospital, Victoria, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bundred', 'Affiliation': 'South Manchester University Hospital, Academic Surgery, Education and Research Center, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Llombart-Cussac', 'Affiliation': 'Hospital Universitàri Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Davidson', 'Affiliation': 'Broomfield Hospital, Chelmsford, Essex, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Frankfurt, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schenk', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq217'] 3298,20444847,Prediction of progressive disease using tumor markers in metastatic breast cancer patients without target lesions in first-line chemotherapy.,"BACKGROUND The aim of this study was to develop a prediction model of progressive disease (PD) in breast cancer patients without measurable disease in first-line chemotherapy. METHODS We developed a model to predict PD using carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 15-3 in metastatic breast cancer patients who were enrolled in a phase III trial. The model was determined using the area under the receiver operating characteristic curve (AUC) calculated by the bootstrap method as internal validation. We verified the model for those who received first-line chemotherapy in a clinical setting as external validation. We categorized patients without measurable disease into PD and non-PD groups and compared the time to progression (TTP). RESULTS The model consisted of percent changes in CEA and CA 15-3 levels from second to third chemotherapy course and baseline abnormality of them. The AUC after external validation was 0.90. Patients without measurable disease were categorized into PD (N = 10) and non-PD groups (N = 53) by the model. The difference in TTP between the two groups was statistically significant (hazard ratio, 0.437; P = 0.021). CONCLUSION The model may be useful to determine PD in metastatic breast cancer patients without measurable disease.",2010,"The difference in TTP between the two groups was statistically significant (hazard ratio, 0.437; P = 0.021). ","['breast cancer patients without measurable disease in first-line chemotherapy', 'metastatic breast cancer patients without target lesions in first-line chemotherapy', 'Patients without measurable disease were categorized into PD (N = 10) and non-PD groups (N = 53) by the model', '15-3 in metastatic breast cancer patients who were enrolled in a phase III trial', 'metastatic breast cancer patients without measurable disease']",['first-line chemotherapy'],"['TTP', 'carcinoembryonic antigen (CEA) and carbohydrate antigen (CA', 'time to progression (TTP']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}, {'cui': 'C0443758', 'cui_str': 'Carbohydrate antigen (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",53.0,0.017398,"The difference in TTP between the two groups was statistically significant (hazard ratio, 0.437; P = 0.021). ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yonemori', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku. Electronic address: kyonemor@ncc.go.jp.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katsumata', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Shimizu', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Management Science, Graduate School of Engineering, Tokyo University of Science, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hirata', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kouno', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Breast and Medical Oncology Division, National Cancer Center Hospital, Chuo-ku.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq213'] 3299,20494961,"Three dose regimens of fulvestrant in postmenopausal Japanese women with advanced breast cancer: results from a double-blind, phase II comparative study (FINDER1).","BACKGROUND FINDER1 compared efficacy, tolerability and pharmacokinetics (PK) of three fulvestrant dose regimens in postmenopausal Japanese women with estrogen receptor (ER)-positive locally advanced/metastatic breast cancer recurring or progressing after prior endocrine therapy. PATIENTS AND METHODS The primary end point of this randomised, multicentre, phase II study was objective response rate (ORR) and the secondary end points included time to progression (TTP), clinical benefit rate (CBR), PK profiles and tolerability. Postmenopausal women with ER-positive advanced breast cancer were randomised to 28-day cycles of fulvestrant approved dose (AD), loading dose (LD) or high dose (HD) until disease progression. RESULTS Hundred and forty-three patients (median age 61 years) received fulvestrant AD (n = 45), LD (n = 51) or HD (n = 47). ORR was similar across dose regimens: 11.1%, 17.6% and 10.6% for AD, LD and HD, respectively, with overlapping confidence intervals. TTP and CBR were also similar between groups (median TTP: 6.0, 7.5 and 6.0 months, respectively; CBR: 42.2%, 54.9% and 46.8% for AD, LD and HD, respectively). C(max) and area under the plasma concentration-time curve were dose proportional and PK steady state was reached earlier with LD and HD than with AD. All three doses were well tolerated, with a similar adverse-event profile and no emerging safety concerns. CONCLUSION Fulvestrant AD, LD and HD had similar efficacy and tolerability profiles in postmenopausal Japanese women with ER-positive advanced breast cancer.",2010,C(max) and area under the plasma concentration-time curve were dose proportional and PK steady state was reached earlier with LD and HD than with AD.,"['postmenopausal Japanese women with estrogen receptor (ER)-positive locally advanced/metastatic breast cancer recurring or progressing after prior endocrine therapy', 'postmenopausal Japanese women with advanced breast cancer', 'Hundred and forty-three patients (median age 61 years) received', 'postmenopausal Japanese women with ER-positive advanced breast cancer', 'Postmenopausal women with ER-positive advanced breast cancer']","['fulvestrant AD', 'fulvestrant']","['efficacy and tolerability profiles', 'efficacy, tolerability and pharmacokinetics (PK', 'C(max) and area under the plasma concentration-time curve', 'TTP and CBR', 'objective response rate (ORR) and the secondary end points included time to progression (TTP), clinical benefit rate (CBR), PK profiles and tolerability', 'ORR']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.141808,C(max) and area under the plasma concentration-time curve were dose proportional and PK steady state was reached earlier with LD and HD than with AD.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Division of Breast Oncology, National Kyushu Cancer Center, Fukuoka. Electronic address: sohno@nk-cc.go.jp.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rai', 'Affiliation': 'Department of Breast Surgery, Sagara Hospital, Kagoshima.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Breast Surgery, Chiba Cancer Center, Chiba.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Breast Surgery, Seirei Hamamatsu General Hospital, Shizuoka.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwase', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kumamoto University Hospital, Kumamoto.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': ""Department of Breast Surgical Oncology, St Luke's International Hospital, Tokyo.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Surgery, The Japanese Red Cross Nagasaki Atomic Bomb Hospital, Nagasaki.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kamigaki', 'Affiliation': 'Department of Surgery, Sakai Municipal Hospital, Osaka.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noguchi', 'Affiliation': 'Department of Oncology, Osaka University Graduate School of Medicine, Osaka, Japan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq249'] 3300,20497961,SABRE-B: an evaluation of paclitaxel and bevacizumab with or without sunitinib as first-line treatment of metastatic breast cancer.,"BACKGROUND The vascular endothelial growth factor (VEGF) pathway can be targeted through VEGF neutralization or VEGF receptor (VEGFR) blockade using tyrosine kinase inhibition. Because laboratory models suggest that combining these approaches might be synergistic, we sought to evaluate the feasibility and efficacy of combining sunitinib with paclitaxel + bevacizumab (PB). METHODS Patients with human epidermal growth factor receptor 2 (HER2)-negative, metastatic breast cancer receiving first-line chemotherapy were randomized to PB or PB with sunitinib (PBS), with planned escalation of the sunitinib dose. RESULTS Forty-six patients were randomized to PB or PBS with sunitinib dosed at 25 mg p.o. daily. Patients receiving PBS encountered substantial toxicity that precluded adequate treatment. The percentage of patients with grade ≥3 adverse events was greater in the PBS arm than the PB arm (83% versus 57%), and sunitinib dosing was modified in 78% of patients, most often due to neutropenia, febrile neutropenia, and fatigue. In addition, 44% of patients had sunitinib dose reduction to 12.5 mg, and 39% required discontinuation. Patients receiving PBS had more bevacizumab treatment interruptions and discontinuations because of toxicity. Median treatment duration was longer in the PB arm compared with the PBS arm (14.1 versus 11.1 weeks), reflecting early treatment discontinuation of PBS. Because of poor tolerability of the addition of sunitinib to PB, the planned sunitinib dose escalation was halted and the study accrual was terminated. CONCLUSION Adding sunitinib to standard doses of bevacizumab plus paclitaxel for metastatic breast cancer is not feasible. Different strategies will be required to evaluate whether there is additional clinical benefit to combining VEGF/VEGFR-targeted agents.",2010,"Median treatment duration was longer in the PB arm compared with the PBS arm (14.1 versus 11.1 weeks), reflecting early treatment discontinuation of PBS.","['metastatic breast cancer', 'Forty-six patients', 'Patients with human epidermal growth factor receptor 2 (HER2)-negative, metastatic breast cancer receiving first-line chemotherapy']","['PB or PB with sunitinib (PBS', 'paclitaxel + bevacizumab (PB', 'bevacizumab', 'paclitaxel and bevacizumab with or without sunitinib', 'PBS', 'bevacizumab plus paclitaxel']","['neutropenia, febrile neutropenia, and fatigue', 'toxicity', 'percentage of patients with grade ≥3 adverse events', 'Median treatment duration']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",46.0,0.0323903,"Median treatment duration was longer in the PB arm compared with the PBS arm (14.1 versus 11.1 weeks), reflecting early treatment discontinuation of PBS.","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston MA. Electronic address: emayer@partners.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dhakil', 'Affiliation': 'Department of Oncology and Internal Medicine, Cancer Center of Kansas, Wichita, KS.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': 'Department of Oncology and Internal Medicine, The Mark H. Zangmeister Center, Columbus, OH.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sundaram', 'Affiliation': 'Sharp Healthcare, San Diego, CA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kozloff', 'Affiliation': 'Department of Oncology, Ingalls Memorial Hospital, Harvey IL.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Qamar', 'Affiliation': 'Oncology Alliance, Glendale WI.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Volterra', 'Affiliation': 'Department of Medicine (Oncology), Eastchester Cancer Care, Bronx, NY.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Parmar', 'Affiliation': 'Department of Avastin BioOncolgy, Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Samant', 'Affiliation': 'Department of Biostatistics, Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston MA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq260'] 3301,20231298,A multicenter international randomized phase III study comparing cisplatin in combination with irinotecan or etoposide in previously untreated small-cell lung cancer patients with extensive disease.,"BACKGROUND This study compared irinotecan plus cisplatin (IP) with etoposide plus cisplatin (EP) in small-cell lung cancer patients with extensive disease. PATIENTS AND METHODS Patients were randomly assigned to receive cisplatin 80 mg/m(2) and either irinotecan 65 mg/m(2), days 1 and 8 or etoposide 100 mg/m(2), days 1-3, every 3 weeks. RESULTS Baseline characteristics were balanced between patients receiving IP (N = 202) or EP (N = 203). Median overall survival was nonsignificantly superior for patients receiving IP versus EP, 10.2 versus 9.7 months [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.65-1.01, P = 0.06] and 1- and 2-year survival rates were 41.9% versus 38.9% and 16.3% versus 8.2%, respectively. Noninferiority of IP versus EP was established, upper bound of the 95% CI of HR 1.01 (prespecified margin IP/EP <1.25). Overall response (39.1% versus 46.6%) and time to tumor progression (5.4 versus 6.2 months) were not superior for IP. Grade 3/4 vomiting (10.9% versus 4.4%) and diarrhea (15.4% versus 0.5%) were more common in the IP versus EP arm; grade 3/4 neutropenia was more frequent in the EP (59.6%) versus IP arm (38.1%). CONCLUSIONS Our data demonstrate the noninferiority of IP versus EP for survival in primarily Western patients with SCLC-ED. A meta-analysis is required to finally assess the role of irinotecan in this setting.",2010,"Median overall survival was nonsignificantly superior for patients receiving IP versus EP, 10.2 versus 9.7 months [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.65-1.01, P = 0.06] and 1- and 2-year survival rates were 41.9% versus 38.9% and 16.3% versus 8.2%, respectively.","['Patients', 'previously untreated small-cell lung cancer patients with extensive disease', 'small-cell lung cancer patients with extensive disease', 'primarily Western patients with SCLC-ED']","['cisplatin', 'EP', 'irinotecan plus cisplatin (IP) with etoposide plus cisplatin (EP', 'cisplatin 80 mg/m(2) and either irinotecan 65 mg/m(2), days 1 and 8 or etoposide', 'irinotecan or etoposide']","['Overall response', 'diarrhea', '2-year survival rates', 'neutropenia', 'Grade 3/4 vomiting', 'Median overall survival', 'time to tumor progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}]",203.0,0.221339,"Median overall survival was nonsignificantly superior for patients receiving IP versus EP, 10.2 versus 9.7 months [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.65-1.01, P = 0.06] and 1- and 2-year survival rates were 41.9% versus 38.9% and 16.3% versus 8.2%, respectively.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zatloukal', 'Affiliation': 'Department of Pneumology, Third Faculty of Medicine, Faculty Hospital Bulovka and Postgraduate Medical Institute, Charles University, Prague, Czech Republic. Electronic address: zatloukp@fnb.cz.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cardenal', 'Affiliation': ""Department of Medical Oncology, Institut Català d'Oncologia, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Regional Lung Diseases Hospital, Otwock, Poland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gorbunova', 'Affiliation': 'Department of Chemotherapy, Cancer Research Centre, Moscow, Russian Federation.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'N.N. Petrov Research Institute of Oncology of Federal Agency of High-tech Medical Treatment, St Petersburgh, Russian Federation.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cisar', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Soria', 'Affiliation': 'Department of Medicine, Lung Cancer Unit, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Department of Medical Oncology, Hospital Fundación Jiménez Diaz, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Internal Medicine, Thoracic Oncology, Clinic for Thoracic Diseases at the University of Heidelberg, Heidelberg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq036'] 3302,31520725,The LACC Trial and Minimally Invasive Surgery in Cervical Cancer.,,2020,,['Cervical Cancer'],[],[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]",[],[],,0.0290699,,"[{'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Javier F', 'Initials': 'JF', 'LastName': 'Magrina', 'Affiliation': 'Mayo Clinic Arizona, Phoenix, Arizona. Electronic address: jmagrina@mayo.edu.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Zanagnolo', 'Affiliation': 'European Institute of Oncology, Milano, Italy.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Magtibay', 'Affiliation': 'Mayo Clinic Arizona, Phoenix, Arizona.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Mayo Clinic Arizona, Phoenix, Arizona.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Moreno', 'Affiliation': ""Hospital Campus Val d'Hebron, UAB, Barcelona, Spain.""}, {'ForeName': 'Berta-Diaz', 'Initials': 'BD', 'LastName': 'Feijoo', 'Affiliation': 'Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kimmig', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Canis', 'Affiliation': ""Polyclinique de l'Hotel de Dieu, Clermont-Ferrand, France.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bourdel', 'Affiliation': ""Polyclinique de l'Hotel de Dieu, Clermont-Ferrand, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ind', 'Affiliation': 'The London Clinic, London, United Kingdom.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Estape', 'Affiliation': 'South Miami Gynecologic Group, Miami, Florida.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Center of Hope, Reno, Nevada.'}, {'ForeName': 'Pluvio', 'Initials': 'P', 'LastName': 'Coronado', 'Affiliation': 'Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Ponce', 'Affiliation': 'University Hospital of Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lambaudie', 'Affiliation': 'Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Toon', 'Initials': 'T', 'LastName': 'Van Gorp', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Maggioni', 'Affiliation': 'European Institute of Oncology, Milano, Italy.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Narducci', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Van Niewwenhuysen', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van Trappen', 'Affiliation': 'Bruges, Flandre-Occidentale, Belgium.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.09.767'] 3303,20332140,ERCC1 and histopathology in advanced NSCLC patients randomized in a large multicenter phase III trial.,"BACKGROUND Customized chemotherapy is likely to improve outcome in patients with advanced non-small-cell lung cancer (NSCLC). Excision repair cross-complementation group 1 (ERCC1) is a promising biomarker; however, current evidence is inadequate. Impact of ERCC1 status was evaluated among patients participating in a large randomized chemotherapy trial. PATIENTS AND METHODS Four hundred and forty-three patients with advanced NSCLC were enrolled in a phase III trial and were randomly allocated to triplet chemotherapy or standard doublet regimen. Immunohistochemical evaluation for ERCC1 status was mainly carried out on bioptic material. RESULTS Two hundred and sixty-four (59.5%) patients had representative tissue samples for ERCC1 evaluation. Median overall survival (OS) in the ERCC1-negative and ERCC1-positive population was 11.8 and 9.8 months, respectively (P = 0.028). The median OS among patients with adenocarcinomas (n = 122) was 15.2 and 8.3 months, respectively (P = 0.007). Interaction analysis between ERCC1-negative status and adenocarcinomas yielded a hazard ratio of 0.64 for death (P = 0.002). CONCLUSIONS Clinically applicable evaluation of ERCC1 status predicted cisplatin sensitivity in the largest randomized patient population with advanced NSCLC reported to date. The predictive value can be ascribed to the adenocarcinomas emphasizing the relevance of ERCC1 expression in this subgroup.",2010,"Interaction analysis between ERCC1-negative status and adenocarcinomas yielded a hazard ratio of 0.64 for death (P = 0.002). ","['patients participating in a large randomized chemotherapy trial', 'advanced NSCLC patients', 'patients with advanced non-small-cell lung cancer (NSCLC', 'Two hundred and sixty-four (59.5', 'patients had representative tissue samples for ERCC1 evaluation', 'Four hundred and forty-three patients with advanced NSCLC were enrolled in a phase III trial']","['Excision repair cross-complementation group 1 (ERCC1', 'triplet chemotherapy or standard doublet regimen']","['median OS', 'Median overall survival (OS', 'cisplatin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0015249', 'cui_str': 'Excision Repair'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",443.0,0.293198,"Interaction analysis between ERCC1-negative status and adenocarcinomas yielded a hazard ratio of 0.64 for death (P = 0.002). ","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Vilmar', 'Affiliation': 'Department of Oncology, Finsen Centre. Electronic address: adamvilmar@hotmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Santoni-Rugiu', 'Affiliation': 'Department of Pathology, Diagnostic Center, National University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sørensen', 'Affiliation': 'Department of Oncology, Finsen Centre.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq053'] 3304,20423913,"Serious pulmonary toxicity in patients with Hodgkin's lymphoma with SGN-30, gemcitabine, vinorelbine, and liposomal doxorubicin is associated with an FcγRIIIa-158 V/F polymorphism.","BACKGROUND Based on in vitro synergistic cytotoxicity when anti-CD30 antibodies are combined with gemcitabine, the Cancer and Leukemia Group B conducted a double-blind, randomized, phase II trial of SGN-30 with gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD) in patients with relapsed Hodgkin's lymphoma. PATIENTS AND METHODS In part 1 of the trial, 16 patients received SGN-30 with GVD to assess the safety of the combination. In part 2, patients were randomly allocated to SGN-30 (n = 7) or placebo (n = 7) with GVD to determine overall response rate (ORR). RESULTS ORR in all 30 patients was 63% (65% with SGN-30 plus GVD, n = 23, and 57% with placebo plus GVD, n = 7). Median event-free survival was 9.0 months, with no difference between the two arms. Grades 3-5 pneumonitis occurred in five patients receiving SGN-30 and GVD, leading to premature closure of the trial. All five patients with pulmonary toxicity had a V/F polymorphism in the FcγRIIIa gene (P = 0.008). CONCLUSIONS Together with historical data demonstrating a 2% incidence of pulmonary events with GVD, these results indicate that SGN-30 cannot safely be administered concurrently. The risk of pneumonitis with SGN-30 and GVD is greatest in patients with an FcγRIIIa V/F polymorphism.",2010,"Grades 3-5 pneumonitis occurred in five patients receiving SGN-30 and GVD, leading to premature closure of the trial.","[""patients with relapsed Hodgkin's lymphoma"", ""patients with Hodgkin's lymphoma with SGN-30""]","['gemcitabine', 'gemcitabine, vinorelbine, and liposomal doxorubicin', 'placebo', 'GVD', 'SGN-30 with GVD', 'SGN-30 with gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD', 'SGN-30']","['Median event-free survival', 'Serious pulmonary toxicity', 'risk of pneumonitis with SGN-30 and GVD', 'overall response rate (ORR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0529908,"Grades 3-5 pneumonitis occurred in five patients receiving SGN-30 and GVD, leading to premature closure of the trial.","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Division of Hematology-Oncology, The Ohio State University Medical Center, Columbus, OH. Electronic address: kristie.blum@osumc.edu.'}, {'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'CALGB Statistical Center, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'CALGB Statistical Center, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Lin', 'Affiliation': 'Division of Hematology-Oncology, The Ohio State University Medical Center, Columbus, OH.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Clinical Pathology, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Lucas', 'Affiliation': 'Division of Hematology-Oncology, The Ohio State University Medical Center, Columbus, OH.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Division of Hematology-Oncology, The Ohio State University Medical Center, Columbus, OH.'}, {'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Division of Hematology-Oncology, Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Hematology-Oncology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq211'] 3305,20427348,Treatment-emergent hypertension and outcomes in patients with advanced non-small-cell lung cancer receiving chemotherapy with or without the vascular endothelial growth factor receptor inhibitor cediranib: NCIC Clinical Trials Group Study BR24.,"BACKGROUND Hypertension (HTN), a recognized adverse effect of angiogenesis inhibitors, may be a potential biomarker of activity of these agents. We conducted a retrospective analysis to examine the incidence and predictors of the development of on-treatment HTN with the vascular endothelial growth factor receptor tyrosine kinase inhibitor cediranib, and the relationship of this adverse event with treatment outcomes. PATIENTS AND METHODS BR24 was a double-blind placebo-controlled phase II trial of carboplatin/paclitaxel chemotherapy with either daily oral cediranib or placebo in patients (n = 296) with advanced non-small-cell lung cancer (NSCLC). Exploratory analyses characterized relationships between HTN, baseline variables, and efficacy outcomes. RESULTS New onset or worsening of preexisting HTN (treatment-emergent HTN) was more frequent in patients receiving cediranib (68 versus 45%, P < 0.0001). Factors associated with HTN in all randomized patients were good performance status and treatment with cediranib. In both arms, treatment-emergent HTN was associated with improved efficacy outcomes, but there was no evidence of a differential treatment effect, with nonsignificant interaction P values. CONCLUSIONS In advanced NSCLC, HTN is frequent in patients receiving chemotherapy, with or without cediranib. The development of HTN was favorably prognostic in these patients, but not predictive of a differential outcome with cediranib.",2010,"In both arms, treatment-emergent HTN was associated with improved efficacy outcomes, but there was no evidence of a differential treatment effect, with nonsignificant interaction P values. ","['patients (n = 296) with advanced non-small-cell lung cancer (NSCLC', 'patients receiving chemotherapy, with or without', 'patients with advanced non-small-cell lung cancer receiving chemotherapy with or without the vascular endothelial growth factor receptor inhibitor cediranib']","['cediranib', 'carboplatin/paclitaxel chemotherapy with either daily oral cediranib or placebo', 'placebo']",['efficacy outcomes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}]","[{'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],296.0,0.183713,"In both arms, treatment-emergent HTN was associated with improved efficacy outcomes, but there was no evidence of a differential treatment effect, with nonsignificant interaction P values. ","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Goodwin', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Seymour', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'LeMaître', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arnold', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dediu', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fenton', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zukin', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walde', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Laberge', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vincent', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Ellis', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Laurie', 'Affiliation': ""NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada. Electronic address: slaurie@ottawahospital.on.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq221'] 3306,32005093,Pain-Free Versus Pain-Threshold Rehabilitation Following Acute Hamstring Strain Injury: A Randomized Controlled Trial.,"OBJECTIVE The primary aim was to compare time from acute hamstring strain injury (HSI) to return-to-play (RTP) clearance following a standardized rehabilitation protocol performed within either pain-free or pain-threshold limits. Secondary aims were to compare isometric knee flexor strength, biceps femoris long head (BFLH) fascicle length, fear of movement, and reinjury occurrence at the 6-month follow-up between pain-free and pain-threshold groups. DESIGN Randomized controlled trial. METHODS Forty-three men with acute HSIs were randomly allocated to a pain-free (n = 22) or pain-threshold (n = 21) rehabilitation group. Days from HSI to RTP clearance, isometric knee flexor strength, BFLH fascicle length, fear of movement, and reinjury occurrence at the 6-month follow-up were reported. RESULTS Median time from HSI to RTP clearance was 15 days (95% confidence interval [CI]: 13, 17) in the pain-free group and 17 days (95% CI: 11, 24) in the pain-threshold group, which was not significantly different ( P = .37). Isometric knee flexor strength recovery at 90° of hip and 90° of knee flexion was greater in the pain-threshold group at RTP clearance by 15% (95% CI: 1%, 28%) and by 15% (95% CI: 1%, 29%) at 2-month follow-up, respectively. Improvement in BFLH fascicle length from baseline was 0.91 cm (95% CI: 0.34, 1.48) greater at 2-month follow-up in the pain-threshold group. Two reinjuries occurred in both the pain-free and pain-threshold groups between RTP clearance and the 6-month follow-up. CONCLUSION Pain-threshold rehabilitation did not accelerate RTP clearance, but resulted in greater recovery of isometric knee flexor strength and better maintenance of BFLH fascicle length, compared to pain-free rehabilitation. J Orthop Sports Phys Ther 2020;50(2):91-103. Epub 28 Jun 2019. doi:10.2519/jospt.2020.8895 .",2020,"Pain-threshold rehabilitation did not accelerate RTP clearance, but resulted in greater recovery of isometric knee flexor strength and better maintenance of BFLH fascicle length, compared to pain-free rehabilitation. ","['Forty-three men with acute HSIs', 'Acute Hamstring Strain Injury']","['acute hamstring strain injury (HSI) to return-to-play (RTP) clearance', 'Pain-Free Versus Pain-Threshold Rehabilitation', 'J Orthop Sports', 'pain-threshold (n = 21) rehabilitation group']","['isometric knee flexor strength and better maintenance of BFLH fascicle length', 'isometric knee flexor strength, biceps femoris long head (BFLH) fascicle length, fear of movement, and reinjury occurrence at the 6-month follow-up between pain-free and pain-threshold groups', 'pain-free and pain', 'knee flexion', 'BFLH fascicle length', 'Isometric knee flexor strength recovery', 'RTP clearance, isometric knee flexor strength, BFLH fascicle length, fear of movement, and reinjury occurrence', 'Median time from HSI to RTP clearance']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",43.0,0.113345,"Pain-threshold rehabilitation did not accelerate RTP clearance, but resulted in greater recovery of isometric knee flexor strength and better maintenance of BFLH fascicle length, compared to pain-free rehabilitation. ","[{'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Timmins', 'Affiliation': ''}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Maniar', 'Affiliation': ''}, {'ForeName': 'Ebonie', 'Initials': 'E', 'LastName': 'Rio', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Pitcher', 'Affiliation': ''}, {'ForeName': 'Morgan D', 'Initials': 'MD', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Opar', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.8895'] 3307,32004698,Ocular symptoms improvement from intranasal triamcinolone compared with placebo and intranasal fluticasone propionate: A meta-analysis.,"BACKGROUND Allergic rhinitis is a prevalent disease, which can be classed as seasonal (SAR) or perennial. In addition to nasal symptoms, up to 75% of sufferers experience itching, redness, and tearing of the eyes. Intranasal corticosteroids are effective in controlling the allergic nasal symptoms, and increasing evidence suggests that they also can relieve some of the allergic ocular symptoms. OBJECTIVE To evaluate the magnitude of efficacy of triamcinolone acetonide (TAA) compared with placebo or fluticasone propionate (FP) on ocular symptom improvement in patients with SAR. METHODS A meta-analysis of summary data from 8 randomized, double- or single-blind trials, assessing mean change in total or individual (tearing, redness, and itching) eye symptoms was conducted. Trials that administered a daily dose of 220 μg TAA vs placebo or 200 μg FP over at least 2 weeks' duration, in patients aged 12 years or older with SAR, were analyzed. RESULTS Total eye symptom reduction after 2 weeks was greater with TAA than placebo, with a mean treatment difference of -0.32 (95% CI, -0.444 to -0.203). In addition, significant reductions in tearing, but not itching or redness, were observed after TAA treatment compared with placebo. No significant treatment difference was seen between TAA and FP in total ocular symptoms at any of the time points measured (weeks 1, 2, 3, and overall). All treatments exhibited similar safety profiles and were deemed well tolerated. CONCLUSION The meta-analysis demonstrated the positive clinical improvements TAA has on total ocular allergy symptoms, especially tearing, in addition to its recognized nasal symptom efficacy in SAR.",2020,"In addition, significant reductions in tearing, but not itching or redness, were observed following TAA treatment compared with placebo.","['patients with SAR', 'patients aged ≥12 years with SAR were analyzed']","['Intranasal corticosteroids', 'placebo or fluticasone propionate (FP', 'triamcinolone acetonide (TAA', '220 μg TAA vs placebo', 'placebo', 'Placebo and Intranasal Fluticasone Propionate', 'Intranasal Triamcinolone']","['tolerated', 'ocular symptom improvement', 'TAA and FP in total ocular symptoms', 'Total eye symptom reduction', 'Ocular Symptoms Improvement', 'mean change in total or individual (tearing, redness and itching) eye symptoms', 'itching or redness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1175743', 'cui_str': 'Severe acute respiratory syndrome-related coronavirus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",,0.51655,"In addition, significant reductions in tearing, but not itching or redness, were observed following TAA treatment compared with placebo.","[{'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bielory', 'Affiliation': 'Hackensack Meridian School of Medicine at Seton Hall University, Departments of Medicine and Ophthalmology, Nutley, New Jersey. Electronic address: drlbielory@gmail.com.'}, {'ForeName': 'Gary N', 'Initials': 'GN', 'LastName': 'Gross', 'Affiliation': 'Dallas Allergy and Asthma Center, Dallas, Texas.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Biostatistics Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Melas-Melt', 'Affiliation': 'Biostatistics, Ividata, Levallois-Perret, France.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Lucio', 'Affiliation': 'Consumer Healthcare, Medical Department, Sanofi, São Paulo, Brazil.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.01.012'] 3308,31818723,A Randomized Study Comparing Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Therapy in a Sample of Women Struggling to Achieve Orgasm.,"INTRODUCTION This study examines the effectiveness of integrating mindfulness-based techniques within therapy for women suffering to achieve orgasm. Although widely applied in psychotherapy, this approach has only recently been introduced in the treatment of female sexual dysfunction. AIM To compare the effectiveness of a video-based self-administered treatment, rooted within the cognitive behavioral treatment (CBT) framework, with a video-based self-administered mindfulness treatment applying cognitive behavioral sexual therapy (mindfulness-based cognitive therapy), the latter of which was specifically created to increase women's ability to achieve orgasm. METHODS A convenience sample of 65 women suffering from difficulties to achieve orgasm, aged 18 to 58 years (mean = 32.66, standard deviation = 9.48), were randomly allocated using a randomization procedure to either a mindfulness-based cognitive therapy (N = 35) or CBT (N = 30) group. Each participant completed questionnaires before and after the start of treatment and 2 months after its completion. MAIN OUTCOME MEASURE We applied repeated-measure general linear models to compare the 2 groups (ie, between participant factor) on each dependent variable across time (ie, the within-participant factor). Compare mean analyses for paired samples were only conducted when the interaction effect between condition and time was significant (ie, P <.05). RESULTS Statistical analyses show that women in both groups presented increased sexual functioning (P = .001) and decreased sexual distress (P < .001), as well as improved desire, arousal, orgasm, and sexual satisfaction (P < .05) after their respective treatments. Contrary to our hypothesis, significant reductions in sexual pain were only observed in CBT participants. CLINICAL IMPLICATIONS To the best of our knowledge, this is the first study to apply a randomized allocation procedure to evaluate the effectiveness of a video-based mindfulness intervention for women struggling to achieve orgasm. These results should guide clinicians' decisions with respect to evaluating the relevance and the real added value of proposing mindfulness exercises to their patients with such difficulties. CONCLUSION When women suffering from difficulties to achieve orgasm are randomly assigned to a mindfulness group or an active control, improvements in sexual functioning and reductions in sexual distress can be observed after both treatments. Adam F, De Sutter P, Day J, et al. A Randomized Study Comparing Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Treatment in a Sample of Women Struggling to Achieve Orgasm. J Sex Med 2020;17:312-324.",2020,"RESULTS Statistical analyses show that women in both groups presented increased sexual functioning (P = .001) and decreased sexual distress (P < .001), as well as improved desire, arousal, orgasm, and sexual satisfaction (P < .05) after their respective treatments.","['65 women suffering from difficulties to achieve orgasm, aged 18 to 58 years (mean\xa0= 32.66, standard deviation\xa0= 9.48', 'a Sample of Women Struggling to Achieve Orgasm', 'women suffering from difficulties to achieve orgasm', 'women struggling to achieve orgasm', 'women suffering to achieve orgasm', 'a Sample of Women']","['integrating mindfulness-based techniques within therapy', 'video-based mindfulness intervention', 'mindfulness-based cognitive therapy (N\xa0= 35) or CBT', 'Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Treatment', 'Video-Based Mindfulness-Based Cognitive Therapy With Video-Based Traditional Cognitive Behavioral Therapy', 'video-based self-administered treatment, rooted within the cognitive behavioral treatment (CBT) framework, with a video-based self-administered mindfulness treatment applying cognitive behavioral sexual therapy (mindfulness-based cognitive therapy']","['sexual functioning', 'sexual pain', 'sexual functioning and reductions in sexual distress', 'improved desire, arousal, orgasm, and sexual satisfaction', 'sexual distress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}]",65.0,0.0244962,"RESULTS Statistical analyses show that women in both groups presented increased sexual functioning (P = .001) and decreased sexual distress (P < .001), as well as improved desire, arousal, orgasm, and sexual satisfaction (P < .05) after their respective treatments.","[{'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Adam', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium. Electronic address: francoise.adam@uclouvain.be.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'De Sutter', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Day', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Grimm', 'Affiliation': 'Psychological Sciences Research Intstitute, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.022'] 3309,31343543,Feasibility of 24-h central blood pressure monitoring: experience from multinational clinical trial assessing the efficacy of perindopril/indapamide/amlodipine.,"OBJECTIVES Brachial blood pressure (BP) is a predictor of cardiovascular events. Evidence suggests that central BP (CBP) provides additional information for cardiovascular risk assessment. Methods to assess 24-h CBP are now available. Our objective was to assess the feasibility of 24-h CBP monitoring in clinical trials and its ability for drug evaluation. METHODS Data are issued from an international phase 3 randomized clinical trial comparing the efficacy of perindopril/indapamide/amlodipine vs. perindopril/indapamide (Per/Ind), in uncontrolled hypertensive patients treated with Per/Ind. 24-h ambulatory BP monitoring (ABPM) was performed at baseline and after 1-month treatment using the Mobil-O-Graph device which provide brachial BP and CBP and arterial parameters. RESULTS From the 345 patients included in the ABPM substudy, 276 had two valid ABPM (M0 and M1) for brachial BP assessment (80%). After applying device/software built-in and expert quality control criteria on these recordings, 210 (76%) had valid data at M0 and M1 for the assessment of CBP. After 1 month, superior ambulatory central SBP reductions were observed in the perindopril/indapamide/amlodipine (n = 101) vs. Per/Ind group (n = 109) for 24-h/daytime/night-time periods (-4.5 mmHg, P = 0.002/-5.0, P < 0001/-4.1 mmHg, P = 0.016, respectively). Similar trends were observed for pulse wave velocity and other central parameters. CONCLUSION Recording 24-h central ABPM and its derived arterial parameters needs a strict expert quality control and must consider a loss of up to 39% of the population included in the ABPM substudy. This method can be used to assess drug effect.",2019,"After 1 month, superior ambulatory central SBP reductions were observed in the perindopril/indapamide/amlodipine (n = 101) vs. Per/Ind group (n = 109) for 24-h/daytime/night-time periods (","['uncontrolled hypertensive patients treated with Per/Ind', '345 patients included in the ABPM substudy, 276 had two valid ABPM (M0 and M1) for brachial BP assessment (80']","['perindopril/indapamide/amlodipine', '24-h central blood pressure monitoring', 'central BP (CBP', 'perindopril/indapamide/amlodipine vs. perindopril/indapamide']","['superior ambulatory central SBP reductions', '24-h ambulatory BP monitoring (ABPM', 'pulse wave velocity and other central parameters', 'Brachial blood pressure (BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",345.0,0.0769306,"After 1 month, superior ambulatory central SBP reductions were observed in the perindopril/indapamide/amlodipine (n = 101) vs. Per/Ind group (n = 109) for 24-h/daytime/night-time periods (","[{'ForeName': 'Jirar', 'Initials': 'J', 'LastName': 'Topouchian', 'Affiliation': 'Paris-Descartes University, AP-HP, Diagnosis and Therapeutic Center, Hôtel Dieu.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Mourad', 'Affiliation': 'Department of Internal Medicine & ESH Excellence Centre, St Joseph Hospital, Paris.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'De Champvallins', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Feldmann', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Asmar', 'Affiliation': 'Foundation-Medical Research Institutes, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hypertension,['10.1097/HJH.0000000000002199'] 3310,31990581,Effectiveness of collagen supplementation on pain scores in healthy individuals with self-reported knee pain: a randomized controlled trial.,"The purpose of this study was to examine the effects of 12 weeks collagen peptide (CP) supplementation on knee pain and function in individuals with self-reported knee pain. Healthy physically active individuals ( n = 167; aged 63 [interquartile range = 56-68] years) with self-reported knee pain received 10 g/day of CP or placebo for 12 weeks. Knee pain and function were measured with the Visual Analog Scale (VAS), the Lysholm questionnaire, and the Knee injury and Osteoarthritis Outcome Score (KOOS). Furthermore, we assessed changes in inflammatory, cartilage, and bone (bio)markers. Measurements were conducted at baseline and after 12 weeks of supplementation. Baseline VAS did not differ between CP and placebo (4.7 [2.5-6.1] vs. 4.7 [2.8-6.2], p = 0.50), whereas a similar decrease in VAS was observed after supplementation (-1.6 ± 2.4 vs. -1.9 ± 2.6, p = 0.42). The KOOS and Lysholm scores increased after supplementation in both groups ( p values < 0.001), whereas the increase in the KOOS and Lysholm scores did not differ between groups ( p = 0.28 and p = 0.76, respectively). Furthermore, CP did not impact inflammatory, cartilage, and bone (bio)markers ( p values > 0.05). A reduced knee pain and improved knee function were observed following supplementation, but changes were similar between groups. This suggests that CP supplementation over a 12-week period does not reduce knee pain in healthy, active, middle-aged to elderly individuals. Novelty CP supplementation over a 12-week period does not reduce knee pain in healthy, active, middle-aged to elderly individuals. CP supplementation over a 12-week period does not impact on inflammatory, cartilage, and bone (bio)markers in healthy, active, middle-aged to elderly individuals.",2020,"The KOOS and Lysholm scores increased after supplementation in both groups (p-values<0.001), whereas the increase in KOOS and Lysholm score did not differ between groups (p=0.28 and p=0.76, respectively).","['individuals with self-reported knee pain. N=167', 'healthy individuals with self-reported knee pain', 'Healthy physically active individuals (63[IQR=56-68] years) with self-reported knee pain received 10 g/day of', 'healthy active middle-aged to elderly individuals']","['CP and placebo', 'collagen peptide (CP) supplementation', 'collagen supplementation', 'CP supplementation', 'CP or placebo']","['Knee pain and function', 'inflammatory-, cartilage- and bone (bio)markers', 'knee pain and function', 'KOOS and Lysholm scores', 'KOOS and Lysholm score', 'Baseline VAS', 'Visual Analog Scale (VAS), Lysholm questionnaire and Knee injury and Osteoarthritis Outcome Score (KOOS', 'pain scores', 'VAS', 'knee pain', 'knee pain and improved knee function']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",167.0,0.0901257,"The KOOS and Lysholm scores increased after supplementation in both groups (p-values<0.001), whereas the increase in KOOS and Lysholm score did not differ between groups (p=0.28 and p=0.76, respectively).","[{'ForeName': 'Coen C W G', 'Initials': 'CCWG', 'LastName': 'Bongers', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Dominique S M', 'Initials': 'DSM', 'LastName': 'Ten Haaf', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Milène', 'Initials': 'M', 'LastName': 'Catoire', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Bregina', 'Initials': 'B', 'LastName': 'Kersten', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Jeroen A', 'Initials': 'JA', 'LastName': 'Wouters', 'Affiliation': 'Sports Centre Papendal/Eat2Move, Arnhem 6816VD, the Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0654'] 3311,31493677,The role of oxytocin in the facial mimicry of affiliative vs. non-affiliative emotions.,"The present paper builds upon a growing body of work documenting oxytocin's role in social functioning, to test whether this hormone facilitates spontaneous mimicry of others' emotional expressions. In a double-blind, randomized trial, adult Caucasian males (n = 145) received a nasal spray of either oxytocin or placebo before completing a facial mimicry task. Facial expressions were coded using automated face analysis. Oxytocin increased mimicry of facial features of sadness (lips and chin, but not areas around the eyes), an affiliative reaction that facilitates social bonding. Oxytocin also increased mimicry of happiness, but only for individuals who expressed low levels of happiness in response to neutral faces. Overall, participants did not reliably mimic expressions of fear and anger, echoing recent theoretical accounts of emotional mimicry as dependent on the social context. In sum, our findings suggest that oxytocin facilitates emotional mimicry in ways that are conducive to affiliation, pointing to a possible pathway through which oxytocin promotes social bonding.",2019,"Oxytocin also increased mimicry of happiness, but only for individuals who expressed low levels of happiness in response to neutral faces.",['adult Caucasian males (n\u202f=\u202f145'],"['nasal spray of either oxytocin or placebo', 'oxytocin', 'Oxytocin']","['mimicry of happiness', 'mimicry of facial features of sadness (lips and chin', 'Facial expressions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0233577', 'cui_str': 'Mimicry (finding)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}]",,0.17315,"Oxytocin also increased mimicry of happiness, but only for individuals who expressed low levels of happiness in response to neutral faces.","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Pavarini', 'Affiliation': 'Centre for Music and Science, University of Cambridge, 11 West Road, Cambridge CB3 9DP, United Kingdom. Electronic address: gabriela.pavarini@psych.ox.ac.uk.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom. Electronic address: r.sun@uva.nl.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Computer Science and Technology, University of Cambridge, William Gates Building, 15 JJ Thomson Ave, Cambridge CB3 0FD, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cross', 'Affiliation': 'Centre for Music and Science, University of Cambridge, 11 West Road, Cambridge CB3 9DP, United Kingdom.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schnall', 'Affiliation': 'Department of Psychology, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Fischer', 'Affiliation': 'Faculty of Social and Behavioral Sciences, University of Amsterdam, Nieuwe Achtergracht 166, Amsterdam 1018 WV, The Netherlands.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Deakin', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Herchel Smith Building, Robinson Way, Cambridge CB2 0SZ, United Kingdom.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Ziauddeen', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Herchel Smith Building, Robinson Way, Cambridge CB2 0SZ, United Kingdom; Cambridgeshire and Peterborough Foundation Trust, Cambridge CB21 5EF, United Kingdom.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Kogan', 'Affiliation': 'Department of Psychology, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vuillier', 'Affiliation': 'Department of Psychology, University of Cambridge, Downing St, Cambridge CB2 3EB, United Kingdom. Electronic address: lrenshawvuillier@bournemouth.ac.uk.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104377'] 3312,31959047,Restitution of gut microbiota in Ugandan children administered with probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12) during treatment for severe acute malnutrition.,"Severe acute malnutrition (SAM) is a major challenge in low-income countries and gut microbiota (GM) dysbiosis may play a role in its etiology. Here, we determined the GM evolution during rehabilitation from SAM and the impact of probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12) supplementation. The GM (16S rRNA gene amplicon sequencing) of children admitted to hospital with SAM showed distinct composition over admission (e.g. Klebsiella spp., and Enterobacteriaceae spp.), discharge (e.g. Clostridiaceae spp., Veilonella dispar ) and follow-up (e.g. Lactobacillus ruminis, Blautia spp., Faecalibacterium prausnitzii ), reaching similar β- and α-diversity as healthy individuals. Children with diarrhea had reduced distribution of Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity. Children suffering from edematous SAM had diminished proportion of Prevotellaceae, Lachnospiraceae, Ruminoccaceae and a higher α-diversity when compared to non-edematous SAM. Supplementation of probiotics did not influence β-diversity upon discharge or follow-up, but it increased ( p < .05) the number of observed species [SE: > 4.5]. Children where the probiotic species were detected had lower cumulative incidence ( p < .001) of diarrhea during the follow-up period compared to children receiving placebo and children receiving probiotics, but where the probiotics were not detected. The GM of children with non-edematous and edematous SAM differ in composition, which might have implications for future GM targeted treatments. Probiotics treatment reduced the cumulative incidence of diarrhea during the outpatient phase, with the strongest effect in children where the administered probiotics could be detected in the GM.",2020,"Children with diarrhea had reduced distribution of Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity.","['Severe acute malnutrition (SAM', 'Ugandan children', 'children admitted to hospital with SAM', 'severe acute malnutrition']","['Probiotics', 'placebo', 'probiotics ( Lactobacillus rhamnosus GG', 'lactis BB-12']","['diarrhea', 'Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity', 'cumulative incidence of diarrhea', 'cumulative incidence', 'proportion of Prevotellaceae, Lachnospiraceae, Ruminoccaceae and a higher α-diversity']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004660', 'cui_str': 'Bacteroidaceae'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0995357', 'cui_str': 'Moraxellaceae'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0345175,"Children with diarrhea had reduced distribution of Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity.","[{'ForeName': 'Josué L', 'Initials': 'JL', 'LastName': 'Castro-Mejía', 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': ""O'Ferrall"", 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Krych', 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': ""O'Mahony"", 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Hanifa', 'Initials': 'H', 'LastName': 'Namusoke', 'Affiliation': 'Mwanamugimu Nutrition Unit, Department of Paediatrics and Child Health, Mulago National Referral Hospital , Kampala, Uganda.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Lanyero', 'Affiliation': 'Mwanamugimu Nutrition Unit, Department of Paediatrics and Child Health, Mulago National Referral Hospital , Kampala, Uganda.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Kot', 'Affiliation': 'Department of Plant and Environmental Sciences, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Nabukeera-Barungi', 'Affiliation': 'Department of Paediatrics and Child Health, College of Health Sciences, Makerere University , Kampala, Uganda.'}, {'ForeName': 'Kim Fleischer', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}]",Gut microbes,['10.1080/19490976.2020.1712982'] 3313,31999946,"TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial.","BACKGROUND TAS-102 (trifluridine-tipiracil) has shown a significant overall survival benefit compared with placebo in patients with chemorefractory metastatic colorectal cancer. Inspired by the encouraging results of a small phase 1-2 study, C-TASK FORCE, which evaluated the combination of TAS-102 plus bevacizumab in patients with chemorefractory metastatic colorectal cancer, we aimed to compare the efficacy of TAS-102 plus bevacizumab versus TAS-102 monotherapy in patients receiving refractory therapy for metastatic colorectal cancer . METHODS This investigator-initiated, open-label, randomised, phase 2 study enrolled patients (aged ≥18 years) with metastatic colorectal from four cancer centres in Denmark. The main inclusion criteria were histopathologically confirmed metastatic colorectal cancer refractory or intolerant to a fluoropyrimidine, irinotecan, oxaliplatin, and cetuximab or panitumumab (only for RAS wild-type), and WHO performance status of 0 or 1. Previous therapy with bevacizumab, aflibercept, ramucirumab, or regorafenib was allowed but not mandatory. Participants were enrolled and randomly assigned (1:1) in block sizes of two, four, or six by a web-based tool to receive oral TAS-102 (35 mg/m 2 twice daily on days 1-5 and 8-12 every 28 days) alone or combined with intravenous bevacizumab (5 mg/kg on days 1 and 15) until progression, unacceptable toxicity, or patient decision to withdraw. Treatment assignment was not masked, and randomisation was stratified by institution and RAS mutation status. The primary endpoint was investigator-evaluated progression-free survival. All analyses were based on intention to treat. This trial is registered with EudraCT, 2016-005241-23. FINDINGS From Aug 24, 2017, to Oct 31, 2018, 93 patients were enrolled and randomly assigned to TAS-102 (n=47) or TAS-102 plus bevacizumab (n=46). The clinical cut-off date was Feb 15, 2019, after a median follow-up of 10·0 months (IQR 6·8-14·0). Median progression-free survival was 2·6 months (95% CI 1·6-3·5) in the TAS-102 group versus 4·6 months (3·5-6·5) in the TAS-102 plus bevacizumab group (hazard ratio 0·45 [95% CI 0·29-0·72]; p=0·0015). The most frequent grade 3 or worse adverse event was neutropenia (18 [38%] of 47 in the TAS-102 monotherapy group vs 31 [67%] of 46 in the TAS-102 plus bevacizumab group). Serious adverse events were observed in 21 (45%) patients in the TAS-102 group and 19 (41%) in the TAS-102 plus bevacizumab group. No deaths were deemed treatment related. INTERPRETATION In patients with chemorefractory metastatic colorectal cancer, TAS-102 plus bevacizumab, as compared with TAS-102 monotherapy, was associated with a significant and clinically relevant improvement in progression-free survival with tolerable toxicity. The combination of TAS-102 plus bevacizumab could be a new treatment option for patients with refractory metastatic colorectal cancer and could be a practice-changing development. FUNDING Servier.",2020,Median progression-free survival was 2·6 months (95% CI 1·6-3·5) in the TAS-102 group versus 4·6 months (3·5-6·5) in the TAS-102 plus bevacizumab group (hazard ratio 0·45,"['patients receiving refractory therapy for metastatic colorectal cancer ', 'From Aug 24, 2017, to Oct 31, 2018, 93 patients', 'patients with chemorefractory metastatic colorectal cancer', '2016-005241-23', 'patients with refractory metastatic colorectal cancer', 'enrolled patients (aged ≥18 years) with metastatic colorectal from four cancer centres in Denmark', 'only for RAS wild-type), and WHO performance status of 0 or 1']","['bevacizumab, aflibercept, ramucirumab, or regorafenib', 'oral TAS-102 (35 mg/m 2 twice daily on days 1-5 and 8-12 every 28 days) alone or combined with intravenous bevacizumab', 'TAS-102 with or without bevacizumab', 'fluoropyrimidine, irinotecan, oxaliplatin, and cetuximab or panitumumab', 'placebo', 'TAS-102 plus bevacizumab', 'TAS-102 (trifluridine-tipiracil', 'TAS-102 monotherapy', 'TAS-102']","['Median progression-free survival', 'Serious adverse events', 'neutropenia', 'progression-free survival with tolerable toxicity', 'investigator-evaluated progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3873157', 'cui_str': 'Every twenty eight days (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4055631', 'cui_str': 'tipiracil / Trifluridine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",93.0,0.304014,Median progression-free survival was 2·6 months (95% CI 1·6-3·5) in the TAS-102 group versus 4·6 months (3·5-6·5) in the TAS-102 plus bevacizumab group (hazard ratio 0·45,"[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark. Electronic address: per.pfeiffer@rsyd.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Zitnjak', 'Affiliation': 'Department of Oncology, Hospital of Southern Jutland, Soenderborg, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Krogh', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lone Nørgård', 'Initials': 'LN', 'LastName': 'Petersen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Laurids Østergaard', 'Initials': 'LØ', 'LastName': 'Poulsen', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Stine Braendegaard', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Karina Gravgaard', 'Initials': 'KG', 'LastName': 'Thomsen', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Qvortrup', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30827-7'] 3314,30954969,Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study.,"OBJECTIVES The aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up. METHODS In this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time. RESULTS A total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 % (95% CI,24% to 43 %) and 43 % (95% CI, 33% to 53 % (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time. CONCLUSION Up to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 % favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects. TRIAL REGISTRATION NUMBER NTR2754.",2019,"Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time. ","['patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4\u2009and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor', 'patients with rheumatoid arthritis', 'A total of 189 patients', 'Eligible patients', 'patients with rheumatoid arthritis (RA), during 1 year of follow-up']","['gradual tapering csDMARDs or TNF inhibitors', 'tapering anti-TNF', 'Gradual tapering TNF inhibitors versus conventional synthetic DMARDs']","['flare rates of tapering csDMARDs or TNF inhibitors', 'Mean DAS, HAQ-DI and EQ-5D', 'cumulative flare rates', 'proportion of patients with a disease flare', 'DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1\u2009year and over time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count (assessment scale)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",189.0,0.128739,"Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time. ","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Tjallingius Martijn', 'Initials': 'TM', 'LastName': 'Kuijper', 'Affiliation': 'Rheumatology, Maasstad Ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'Myrthe', 'Initials': 'M', 'LastName': 'van der Ven', 'Affiliation': 'Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Cathelijne', 'Initials': 'C', 'LastName': 'Appels', 'Affiliation': 'Rheumatology, Amphia ziekenhuis, Breda, The Netherlands.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Bijkerk', 'Affiliation': 'Rheumatology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Joop B', 'Initials': 'JB', 'LastName': 'Harbers', 'Affiliation': 'Rheumatology, Franciscus ziekenhuis, Roosendaal, The Netherlands.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'de Man', 'Affiliation': 'Rheumatology, Sint Antonius Ziekenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'T H Esmeralda', 'Initials': 'THE', 'LastName': 'Molenaar', 'Affiliation': 'Rheumatology, Groene Hart Ziekenhuis, Gouda, The Netherlands.'}, {'ForeName': 'Ilja', 'Initials': 'I', 'LastName': 'Tchetverikov', 'Affiliation': 'Rheumatology, Albert Schweitzer Ziekenhuis, Dordrecht, The Netherlands.'}, {'ForeName': 'Yvonne P M', 'Initials': 'YPM', 'LastName': 'Goekoop-Ruiterman', 'Affiliation': 'Rheumatology, Haga Ziekenhuis, The Hague, The Netherlands.'}, {'ForeName': 'Jende', 'Initials': 'J', 'LastName': 'van Zeben', 'Affiliation': 'Rheumatology, Franciscus Gasthuis, Rotterdam, The Netherlands.'}, {'ForeName': 'Johanna M W', 'Initials': 'JMW', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Angelique E A M', 'Initials': 'AEAM', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Maasstad Ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'Jolanda J', 'Initials': 'JJ', 'LastName': 'Luime', 'Affiliation': 'Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2018-214970'] 3315,31996940,"Differential effects of nicotine delivery rate on subjective drug effects, urges to smoke, heart rate and blood pressure in tobacco smokers.","RATIONALE The nicotine delivery rate is a key feature of tobacco product design, yet there have been limited human studies examining the effects of nicotine as a function of delivery rate. OBJECTIVE We developed an intravenous nicotine infusion protocol to evaluate differential effects of nicotine delivery rate on subjective drug effects, smoking urges, abstinence symptoms, heart rate, and blood pressure. METHODS Eighteen non-treatment seeking, overnight abstinent male and female smokers (18 to 30 years old), who smoked ≥ 5 cigarettes per day for the past year completed four sessions, in which they were randomly assigned to a saline infusion, or a 1 mg per 70-kg body weight dose of nicotine delivered over 1, 5, or 10 min at rates of 0.24, 0.048, or 0.024 μg/kg/s, respectively. RESULTS Smoking urges, as assessed by the Brief Questionnaire of Smoking Urges, were reduced relative to placebo for the 1- and 5-min infusion, but not the 10-min infusion. Although the 1- and 5-min infusions reduced smoking urges to a similar extent, the 1-min infusion induced a greater heart rate and blood pressure increase. Changes to subjective drug effects, heart rate, and blood pressure delineate the differential effects of nicotine delivery rate for these outcomes. CONCLUSIONS We have characterized the delivery rate-response curve for a nicotine dose that is roughly the amount of nicotine (~ 1 mg) delivered by smoking a standard tobacco cigarette. Our findings reinforce the importance of nicotine delivery rate when evaluating the potential effects of nicotine from tobacco products.",2020,"RESULTS Smoking urges, as assessed by the Brief Questionnaire of Smoking Urges, were reduced relative to placebo for the 1- and 5-min infusion, but not the 10-min infusion.","['tobacco smokers', 'Eighteen non-treatment seeking, overnight abstinent male and female smokers (18 to 30\xa0years old), who smoked ≥\u20095 cigarettes per day for the past year completed four sessions']","['nicotine', 'saline infusion']","['subjective drug effects, heart rate, and blood pressure', 'subjective drug effects, urges to smoke, heart rate and blood pressure', 'Brief Questionnaire of Smoking Urges', 'subjective drug effects, smoking urges, abstinence symptoms, heart rate, and blood pressure', 'heart rate and blood pressure increase']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}]",,0.043994,"RESULTS Smoking urges, as assessed by the Brief Questionnaire of Smoking Urges, were reduced relative to placebo for the 1- and 5-min infusion, but not the 10-min infusion.","[{'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Jensen', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. kevin.jensen@yale.edu.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Valentine', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05463-6'] 3316,32164631,Time-efficient and computer-guided sprint interval exercise training for improving health in the workplace: a randomised mixed-methods feasibility study in office-based employees.,"BACKGROUND The efficacy of high-intensity interval training (HIT) as a time-efficient exercise strategy for beneficially modifying risk factors for cardiovascular disease has repeatedly been demonstrated in controlled laboratory settings. However, the effectiveness of HIT in an unsupervised workplace setting has not been investigated. The objective of this study was to use mixed methods to investigate the feasibility, acceptability and effectiveness of a short-duration, high-intensity exercise intervention (REHIT) when applied unsupervised in a workplace setting. METHODS Twenty-five office-workers (mean ± SD age: 47 ± 9 y, BMI: 27.5 ± 4.4 kg·m - 2 , V̇O 2 max: 28 ± 7 mL·kg - 1 ·min - 1 ) completed a 6-week REHIT intervention unsupervised in their workplace (n = 13, 6 men), or acted as a no-intervention control (n = 12, 6 men). The intervention consisted of 2 sessions/week of low-intensity (~ 25 W) cycling interspersed with 2 'all-out' sprints, increasing in duration from 10 to 20 s per sprint over the 6 weeks (total time-commitment: 8:40 min per session). V̇O 2 max was assessed pre- and post-training, whilst questionnaire-based measures of exercise enjoyment, self-efficacy, and acceptability were completed post-training. Eight participants also completed post-intervention semi-structured interviews. RESULTS V̇O 2 max significantly improved in the exercise group (2.25 ± 0.75 L·min - 1 vs. 2.42 ± 0.82 L·min - 1 ; + 7.4%) compared to the control group (2.22 ± 0.72 L·min - 1 vs. 2.17 ± 0.74 L·min - 1 ; - 2.3%; time*intervention interaction effect: p < 0.01). Participants considered the REHIT intervention acceptable and enjoyable (PACES: 89 ± 17 out of 119) and were confident in their ability to continue to perform REHIT (7.8 ± 1.2 out of 9). Qualitative data revealed that REHIT offered a time-efficient opportunity to exercise, that was perceived as achievable, and which encouraged highly valued post-exercise outcomes (e.g. progress towards health/fitness benefits). CONCLUSIONS REHIT could be implemented as a feasible, effective and acceptable exercise intervention in a workplace setting, with a total time-commitment of < 20 min/week. Consideration of certain psycho-social factors and behaviour-change techniques may ensure adherence to the REHIT programme in the long term. TRIAL REGISTRATION The study was registered on ClinicalTrials.gov on 07/05/2019 (registration: NCT03941145).",2020,2 max significantly improved in the exercise group (2.25 ± 0.75 L·min - 1 vs. 2.42 ± 0.82 L·min - 1 ; + 7.4%) compared to the control group (2.22 ± 0.72 L·min - 1 vs. 2.17 ± 0.74 L·min - 1 ; - 2.3%; time*intervention interaction effect: p < 0.01).,"['Eight participants also completed post-intervention semi-structured interviews', '±\u2009SD age: 47\u2009±\u20099 y, BMI: 27.5\u2009±\u20094.4\u2009kg·m -\u20092 , V̇O 2 max: 28\u2009±\u20097\u2009mL·kg -\u20091 ·min -\u20091 ) completed a', 'Participants considered the REHIT intervention acceptable and enjoyable (PACES: 89\u2009±\u200917 out of 119) and were confident in their ability to continue to perform REHIT (7.8\u2009±\u20091.2 out of 9', 'office-based employees', 'Twenty-five office-workers (mean']","['short-duration, high-intensity exercise intervention (REHIT', '6-week REHIT intervention unsupervised in their workplace (n\u2009=\u200913, 6 men), or acted as a no-intervention control', ""low-intensity (~\u200925\u2009W) cycling interspersed with 2 'all-out' sprints, increasing in duration from 10 to 20\u2009s per sprint"", 'Time-efficient and computer-guided sprint interval exercise training', 'high-intensity interval training (HIT']","['feasibility, acceptability and effectiveness', 'V̇O 2 max was assessed pre- and post-training, whilst questionnaire-based measures of exercise enjoyment, self-efficacy, and acceptability', 'V̇O']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0558095', 'cui_str': 'Confident (finding)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",119.0,0.0467632,2 max significantly improved in the exercise group (2.25 ± 0.75 L·min - 1 vs. 2.42 ± 0.82 L·min - 1 ; + 7.4%) compared to the control group (2.22 ± 0.72 L·min - 1 vs. 2.17 ± 0.74 L·min - 1 ; - 2.3%; time*intervention interaction effect: p < 0.01).,"[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Metcalfe', 'Affiliation': 'Applied Sports Science, Technology, Exercise and Medicine Research Centre (A-STEM), Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'Atef', 'Affiliation': 'Department of Physical Therapy for Internal Medicine, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports Science, Technology, Exercise and Medicine Research Centre (A-STEM), Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Melitta', 'Initials': 'M', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports Science, Technology, Exercise and Medicine Research Centre (A-STEM), Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Ryde', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Hill', 'Affiliation': 'Applied Sports Science, Technology, Exercise and Medicine Research Centre (A-STEM), Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Niels B J', 'Initials': 'NBJ', 'LastName': 'Vollaard', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK. n.vollaard@stir.ac.uk.'}]",BMC public health,['10.1186/s12889-020-8444-z'] 3317,31850931,Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.,"INTRODUCTION The objective was to assess the efficacy and safety of GED-0301, an antisense oligodeoxynucleotide to Smad7, in active Crohn's disease (CD). METHODS This phase 3, blinded study randomized patients (1:1:1:1) to placebo or 1 of 3 once-daily oral GED-0301 regimens: 160 mg for 12 weeks followed by 40 mg continuously or alternating placebo with 40 or 160 mg every 4 weeks through week 52. RESULTS In all, 701 patients were randomized and received study medication before premature study termination; 78.6% (551/701) completed week 12, and 5.8% (41/701) completed week 52. The primary endpoint, clinical remission achievement (CD Activity Index score <150) at week 12, was attained in 22.8% of patients on GED-0301 vs 25% on placebo (P = 0.6210). At study termination, proportions of patients achieving clinical remission at week 52 were similar among individual GED-0301 groups and placebo. More placebo vs GED-0301 patients achieved endoscopic response (>50% decrease from baseline Simple Score for CD) at week 12 (18.1% vs 10.1%). Additional endoscopic endpoints were similar between groups at weeks 12 and 52. More placebo vs GED-0301 patients had clinical response (≥100-point decrease in the CD Activity Index score) at week 12 (44.4% vs 33.3%); at week 52, clinical response rates were similar. Adverse events were predominantly gastrointestinal and related to active CD, consistent with lack of clinical and endoscopic response to treatment. Two deaths occurred (GED-0301 total group) due to small intestinal obstruction and pneumonia; neither was suspected by the investigator to be treatment-related. DISCUSSION GED-0301 did not demonstrate efficacy vs placebo in active CD.",2020,"More placebo vs GED-0301 patients had clinical response (≥100-point decrease in the CD Activity Index score) at week 12 (44.4% vs 33.3%); at week 52, clinical response rates were similar.","[""active Crohn's disease (CD"", ""Active Crohn's Disease"", '701 patients']","['GED-0301', 'placebo']","['clinical response rates', 'Adverse events', 'endoscopic response', 'clinical remission', 'small intestinal obstruction and pneumonia', 'CD Activity Index score', 'clinical remission achievement (CD Activity Index score <150', 'clinical response']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction (disorder)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]",701.0,0.409456,"More placebo vs GED-0301 patients had clinical response (≥100-point decrease in the CD Activity Index score) at week 12 (44.4% vs 33.3%); at week 52, clinical response rates were similar.","[{'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials and Western University, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'University Hospital Schleswig Holstein, Christian-Alrechts-University, Kiel, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Nancy University Hospital, Lorraine University, Inserm NGERE, Vandoeuvre lès Nancy, Nancy, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Frédéric Colombel', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Rossiter', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Usiskin', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Shabana', 'Initials': 'S', 'LastName': 'Ather', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Xiaojiang', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'DʼHaens', 'Affiliation': 'University of Amsterdam, Amsterdam, the Netherlands.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000493'] 3318,31836300,Audiovisual Sexual Stimulation Improves Diagnostic Accuracy of Penile Doppler Ultrasound in Patients With Erectile Dysfunction.,"INTRODUCTION Although penile Doppler ultrasound (PDU) is a useful tool in evaluating erectile dysfunction (ED), an optimal erectile response might be limited because of an increased sympathetic discharge. Audiovisual sexual stimulation (AVSS) has been suggested to help improving PDU performance. AIM To evaluate the use of AVSS as a tool to improve diagnostic accuracy of PDU studies. METHODS A total of 40 men (mean age: 61.8 ± 10.2 years) with ED were enrolled. PDU sessions were performed in a randomized fashion as follows: session A under intracavernous injection (ICI) alone and session B under ICI and AVSS with 7-day interval between sessions. Peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI) were measured 5, 10, 15, and 20 minutes after ICI. MAIN OUTCOME MEASURE Comparisons between PSV, EDV, and RI values were performed with and without AVSS. Univariable and multivariable analyses including clinical and demographic parameters were performed to evaluate predictors of an abnormal PDU. RESULTS 23 patients performed the first session without AVSS, and 17 performed the first session with AVSS. EDV and RI were better in AVSS session (p = 0.022 and 0.019). PSV was not influenced by AVSS (p = 0.768). The proportion of patients whose diagnosis was changed because of the AVSS was 4 of 40 (10.0%, 95% confidence interval [CI]: 2.8-23.7%). Of 12 patients with venous leak observed on the PDU without AVSS, 3 turned into normal after AVSS (25.0%, 95% CI: 5.5-57.2%). Of 4 men with arterial insufficiency observed on the PDU on ICI alone, 1 became normal after AVSS (25.0%, 95% CI: 0.6-80.6%). International Index of Erectile Function-5 scores were lower in patients with abnormal PDU (6.3 ± 3.3 vs 12.0 ± 5.8, p=0.003). On multivariable analysis, DM and International Index of Erectile Function-5 scores were the only independent predictors of abnormal PDU studies. CLINICAL IMPLICATIONS False diagnoses of venous leak during PDU with ICI could be a result of an increased adrenergic discharge during the examination. Routine AVSS may be helpful to avoid error in diagnosis. STRENGTH & LIMITATIONS The study has randomized the use of AVSS in different session orders. Only one previously published study has used this strategy to control the accommodation effect in repeat studies, a common source of bias in the PDU literature. The main limitation is the absence of a rigidity assessment and a redosing protocol. CONCLUSION Adding AVSS during PDU improves ICI response and may help clinicians evaluate penile hemodynamics more accurately. Carneiro F, Nascimento B, Miranda EP, et al. Audiovisual Sexual Stimulation Improves Diagnostic Accuracy of Penile Doppler Ultrasound in Patients With Erectile Dysfunction. J Sex Med 2020;17:249-256.",2020,EDV and RI were better in AVSS session (p = 0.022 and 0.019).,"['Patients With Erectile Dysfunction', 'Patients', 'A total of 40 men (mean age: 61.8 ± 10.2 years) with ED were enrolled']","['Penile Doppler Ultrasound', 'penile Doppler ultrasound (PDU', 'Audiovisual sexual stimulation (AVSS', 'AVSS', 'Audiovisual Sexual Stimulation', 'session A under intracavernous injection (ICI) alone and session B under ICI and AVSS']","['PSV, EDV, and RI values', 'PSV', 'adrenergic discharge', 'ICI response', 'International Index of Erectile Function-5 scores', 'EDV and RI', 'DM and International Index of Erectile Function-5 scores', 'Peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001637', 'cui_str': 'Adrenergic Drugs'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",12.0,0.0736946,EDV and RI were better in AVSS session (p = 0.022 and 0.019).,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Carneiro', 'Affiliation': 'Department of Radiology, University of Sao Paulo, Sao Paulo city, Brazil. Electronic address: drcarneiro91@gmail.com.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Nascimento', 'Affiliation': 'Division of Urology, University of Sao Paulo, Sao Paulo city, Brazil.'}, {'ForeName': 'Eduardo P', 'Initials': 'EP', 'LastName': 'Miranda', 'Affiliation': 'Division of Urology, Federal University of Ceara, Ceara, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cury', 'Affiliation': 'Division of Urology, University of Sao Paulo, Sao Paulo city, Brazil.'}, {'ForeName': 'Giovanni G', 'Initials': 'GG', 'LastName': 'Cerri', 'Affiliation': 'Department of Radiology, University of Sao Paulo, Sao Paulo city, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Chammas', 'Affiliation': 'Department of Radiology, University of Sao Paulo, Sao Paulo city, Brazil.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.11.263'] 3319,31813531,Incidence and Prognostic Impact of Atrial Fibrillation After Discharge Following Revascularization for Significant Left Main Coronary Artery Narrowing.,"The incidence, recurrence rate, and prognostic significance of atrial fibrillation or flutter (AF) following hospital discharge after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown. We sought to determine the 3-year incidence and clinical impact of postdischarge AF in patients with LMCAD treated with PCI or CABG. In the EXCEL trial, 1,905 patients with LMCAD were randomized to PCI versus CABG. We analyzed the occurrence of postdischarge AF through 3 years and its time-adjusted association with adverse outcomes. A total of 1,802 patients without AF at baseline comprised the study cohort. Within 3 years, 227 episodes of AF occurred (29 [12.8%] in the PCI arm and 198 [87.2%] in the CABG arm, p <0.0001); of those, 63 (27.7%) occurred following discharge from the index hospitalization in 57 patients. In-hospital AF predicted postdischarge AF (hazard ratio [HR] 2.94, 95% confidence interval [CI] 1.42 to 6.10, p = 0.004). By multivariable analysis, time-updated postdischarge AF was an independent predictor of 3-year cardiovascular death (HR 4.91, 95% CI 1.92 to 12.60, p = 0.0009), stroke (HR 4.87, 95% CI 1.12 to 21.12, p = 0.035), and the composite outcome of death, stroke or myocardial infarction (HR 3.09, 95% CI 1.56 to 3.6-6.11, p = 0.001). Among patients with postdischarge AF, the rate of the primary composite outcome did not vary according to presence or absence of in-hospital AF (21.0% vs 23.8%, p = 0.78). In conclusion, postdischarge AF following CABG or PCI for LMCAD is associated with increased mortality and stroke. In-hospital atrial fibrillation is an independent predictor of AF following discharge.",2020,"Within 3 years, 227 episodes of AF occurred (29 [12.8%] in the PCI arm and 198 [87.2%] in the CABG arm, p <0.0001); of those, 63 (27.7%) occurred following discharge from the index hospitalization in 57 patients.","['1,802 patients without AF at baseline comprised the study cohort', '1,905 patients with LMCAD', 'patients with LMCAD treated with PCI or CABG']",['PCI versus CABG'],"['mortality and stroke', 'incidence, recurrence rate, and prognostic significance of atrial fibrillation or flutter (AF) following hospital discharge after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD', 'stroke', 'postdischarge AF (hazard ratio [HR', '3-year cardiovascular death', 'presence or absence of in-hospital AF', 'composite outcome of death, stroke or myocardial infarction', 'Incidence and Prognostic Impact of Atrial Fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",1905.0,0.347536,"Within 3 years, 227 episodes of AF occurred (29 [12.8%] in the PCI arm and 198 [87.2%] in the CABG arm, p <0.0001); of those, 63 (27.7%) occurred following discharge from the index hospitalization in 57 patients.","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College of Science, Technology and Medicine, London, United Kingdom.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Paris, France.'}, {'ForeName': 'Paweł E', 'Initials': 'PE', 'LastName': 'Buszman', 'Affiliation': 'Department of Epidemiology and Statistics, Medical University of Silesia, Katowice, Poland; Department of Cardiovascular Research and Development, American Heart of Poland, Ustron, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Bochenek', 'Affiliation': 'University of Technology, Medical Faculty, Katowice, Poland.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Schampaert', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.021'] 3320,31535560,The influence of religious beliefs and practices on health care decision-making among HIV positive adolescents.,"It is unknown if religiousness/spirituality influences end-of-life treatment preferences among adolescents. Investigators assessed whether religiousness/spirituality moderates the relationship between an advance care planning intervention and end-of-life treatment preferences among 85 primarily African-American adolescents living with HIV/AIDS in outpatient-hospital-based HIV-specialty clinics in the United States. Adolescents aged 14-21 years living with HIV/AIDS and their families were randomized to three-weekly-60-minute sessions either: advance care planning (survey, goals of care conversation, advance directive); or control (developmental history, safety tips, nutrition/exercise). At 3-months post-intervention the intervention effect ( decreasing the likelihood of choosing to continue treatments in all situations ) was significantly moderated by religiousness/spirituality. Highly religious/spiritual adolescents were four times more likely to choose to continue treatments in all situations . Thus, intensive treatments at end-of-life may represent health equity, rather than health disparity. The belief believed that HIV is a punishment from God at baseline (15%, 14/94) was not associated with end-of-life treatment preferences. Twelve percent (11/94) reported they had stopped taking HIV medications for more than 3 days because of the belief in a miracle. Religiousness moderates adolescent's medical decision-making. Adolescents who believe in miracles should receive chaplaincy referrals to help maintain medication adherence.",2020,At 3-months post-intervention the intervention effect ( decreasing the likelihood of choosing to continue treatments in all situations ) was significantly moderated by religiousness/spirituality.,"['HIV positive adolescents', 'Adolescents aged 14-21 years living with HIV/AIDS and their families', '85 primarily African-American adolescents living with HIV/AIDS in outpatient-hospital-based HIV-specialty clinics in the United States', 'adolescents']","['advance care planning (survey, goals of care conversation, advance directive); or control (developmental history, safety tips, nutrition/exercise']",['stopped taking HIV medications'],"[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",85.0,0.0456278,At 3-months post-intervention the intervention effect ( decreasing the likelihood of choosing to continue treatments in all situations ) was significantly moderated by religiousness/spirituality.,"[{'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Science/Children's Research Institute, Children's National, Washington, DC, USA.""}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Dallas', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Garvie', 'Affiliation': ""Research Department, Children's Diagnostic & Treatment Center, Fort Lauderdale, FL, USA.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Science/Children's Research Institute, Children's National, Washington, DC, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}]",AIDS care,['10.1080/09540121.2019.1668523'] 3321,32180369,Early improvements of individual symptoms as a predictor of treatment response to asenapine in patients with schizophrenia.,"AIM It is well accepted that early improvement with antipsychotics predicts subsequent response in patients with schizophrenia. However, no study has examined the contribution of individual symptoms rather than overall symptom severity as the predictors. Thus, we aimed to detect individual symptoms whose improvements could predict subsequent response in patients with schizophrenia during treatment with asenapine and examine whether a prediction model with individual symptoms would be superior to a model using overall symptom severity. METHODS This study analyzed a dataset including 532 patients with schizophrenia enrolled in a 6-week double-blind, placebo-controlled, randomized trial of asenapine. Response to asenapine was defined as a ≥30% decrease in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 6. Stepwise logistic regression analyses were performed to investigate the associations among response and PANSS total/individual item score improvements at week 1 or week 2. RESULTS Response was associated with early improvement in the following PANSS items: disturbance of volition, active social avoidance, poor impulse control at week 1; and active social avoidance, poor attention, lack of judgment and insight at week 2. Prediction accuracy was almost compatible between the model with individual symptoms and the model with PANSS total score both at weeks 1 and 2 (Nagelkerke R 2 : .51, .42 and .55, .54, respectively). CONCLUSION Early improvement in negative symptoms, poor attention and impulse control, and lack of insight, in particular predicted subsequent treatment response in patients with schizophrenia during treatment with asenapine as accurately as prediction based on overall symptom severity.",2020,"Early improvement in negative symptoms, poor attention and impulse control, and lack of insight, in particular predicted subsequent treatment response in patients with schizophrenia during treatment with asenapine as accurately as prediction based on overall symptom severity.","['532 patients with schizophrenia enrolled', 'patients with schizophrenia during treatment with', 'patients with schizophrenia']","['asenapine', 'antipsychotics', 'placebo']","['negative symptoms, poor attention and impulse control, and lack of insight', 'individual symptoms', 'PANSS items: disturbance of volition, active social avoidance, poor impulse control at week 1; and active social avoidance, poor attention, lack of judgment and insight', 'Positive and Negative Syndrome Scale (PANSS) total score', 'Prediction accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0233824', 'cui_str': 'Lack of insight (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",532.0,0.0152537,"Early improvement in negative symptoms, poor attention and impulse control, and lack of insight, in particular predicted subsequent treatment response in patients with schizophrenia during treatment with asenapine as accurately as prediction based on overall symptom severity.","[{'ForeName': 'Kamiyu', 'Initials': 'K', 'LastName': 'Ogyu', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Noda', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Pharmacogenetic Research Clinic, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kurose', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Fumi', 'Initials': 'F', 'LastName': 'Masuda', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Nishida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Plitman', 'Affiliation': 'Cerebral Imaging Centre, Douglas Mental Health University Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Tarumi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Tsugawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Wada', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Graff-Guerrero', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12103'] 3322,31270506,Investigation of the role of typhoid toxin in acute typhoid fever in a human challenge model.,"Salmonella Typhi is a human host-restricted pathogen that is responsible for typhoid fever in approximately 10.9 million people annually 1 . The typhoid toxin is postulated to have a central role in disease pathogenesis, the establishment of chronic infection and human host restriction 2-6 . However, its precise role in typhoid disease in humans is not fully defined. We studied the role of typhoid toxin in acute infection using a randomized, double-blind S. Typhi human challenge model 7 . Forty healthy volunteers were randomized (1:1) to oral challenge with 10 4 colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi. We observed no significant difference in the rate of typhoid infection (fever ≥38 °C for ≥12 h and/or S. Typhi bacteremia) between participants challenged with wild-type or TN S. Typhi (15 out of 21 (71%) versus 15 out of 19 (79%); P = 0.58). The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001). The clinical syndrome was otherwise indistinguishable between wild-type and TN groups. These data suggest that the typhoid toxin is not required for infection and the development of early typhoid fever symptoms within the context of a human challenge model. Further clinical data are required to assess the role of typhoid toxin in severe disease or the establishment of bacterial carriage.",2019,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,['Forty healthy volunteers'],"['oral challenge with 10 4 colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi', 'typhoid toxin']","['rate of typhoid infection', 'duration of bacteremia']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]","[{'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]",40.0,0.136122,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,"[{'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK. malick.gibani@paediatrics.ox.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meek', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Heinz', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Rosenberg-Hasson', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Obermoser', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Black', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Darlow', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Silva-Reyes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lara-Tejero', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xuyao', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Stack', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Blohmke', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Dougan', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Galán', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}]",Nature medicine,['10.1038/s41591-019-0505-4'] 3323,32022483,A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma.,"OBJECTIVES Asthma affects over 6 million children in the United States alone. This study investigated the efficacy and long-term safety of mometasone furoate-formoterol (MF/F) and MF monotherapy in children with asthma. MATERIALS AND METHODS This phase 3, multicenter, randomized controlled trial evaluated metered-dose inhaler twice daily (BID) dosing with MF/F 100/10 µg or MF 100 µg in children, aged 5 to 11 years, with a history of asthma for greater than or equal to 6 months and confirmed bronchodilator reversibility, who were adequately controlled on inhaled corticosteroid/long-acting beta-agonist combination therapy for greater than or equal to 4 weeks. After a 2-week run-in on MF 100 µg BID, eligible patients received 24 weeks of double-blind treatment and were followed for safety up to 26 weeks. The primary efficacy endpoint was the change from baseline in AM postdose 60-minute AUC %predicted FEV1% across 12 weeks of treatment. RESULTS A total of 181 participants received at least one dose of MF/F (n = 91) or MF (n = 90). MF/F was superior to MF across the 12-week evaluation period, with a treatment advantage of 5.21 percentage points (P < .001). Superior onset of action with MF/F over MF was achieved as early as 5 minutes postdose on day 1. Overall, approximately 50% of participants experienced one or more treatment-emergent adverse events, with fewer occurring in the MF/F group. CONCLUSIONS In children 5 to 11 years of age with persistent asthma, the addition of F to MF was well tolerated and provided significant, rapid, and sustained improvement in lung function compared with MF alone.",2020,"MF/F was superior to MF across the 12-week evaluation period, with a treatment advantage of 5.21 percentage points (P < .001).","['100\u2009µg in children, aged 5 to 11 years, with a history of asthma for greater than or equal to 6 months and confirmed bronchodilator reversibility, who were adequately controlled on inhaled corticosteroid/long-acting beta-agonist combination therapy for greater than or equal to 4 weeks', 'children with asthma', '181 participants received at least one dose of', 'persistent asthma', '6 million children in the United States alone']","['mometasone furoate-formoterol (MF/F) and MF monotherapy', 'MF/F', 'mometasone furoate with and without formoterol', 'MF/F 100/10\u2009µg or MF', 'MF']","['safety and efficacy', 'lung function', 'change from baseline in AM postdose 60-minute AUC %predicted FEV1', 'treatment-emergent adverse events']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0455544', 'cui_str': 'H/O: asthma'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0449261', 'cui_str': 'Reversibility (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",181.0,0.124179,"MF/F was superior to MF across the 12-week evaluation period, with a treatment advantage of 5.21 percentage points (P < .001).","[{'ForeName': 'Cindy L J', 'Initials': 'CLJ', 'LastName': 'Weinstein', 'Affiliation': 'Merck & Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Davis', 'Initials': 'D', 'LastName': 'Gates', 'Affiliation': 'Merck & Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Varnell', 'Affiliation': 'Merck & Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Mok', 'Affiliation': 'Merck & Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Vermeulen', 'Affiliation': 'Panorama Medical Centre, Panorama, Cape Town, South Africa.'}, {'ForeName': 'Niran J', 'Initials': 'NJ', 'LastName': 'Amar', 'Affiliation': 'Allergy Asthma Research Institute, Waco, Texas.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Arizona Allergy and Immunology Research LLC, Gilbert, Arizona.'}]",Pediatric pulmonology,['10.1002/ppul.24667'] 3324,32174572,Comparative clinical trial of intracameral ropivacaine vs. lignocaine in subjects undergoing phacoemulsification under augmented topical anesthesia.,"Purpose To compare intracameral Ropivacaine to Lignocaine during phacoemulsification under augmented topical anesthesia, in terms of efficacy and safety. Methods This prospective, randomized, double-masked clinical trial included subjects planned for phacoemulsification with posterior chamber intraocular lens implantation for visually significant uncomplicated senile cataract, under augmented topical anesthesia. Cases were randomized into two groups, Group A (Ropivacaine 0.1%) or Group B (Lignocaine 1.0%). The pain experienced by the patients during the surgery, mydriasis, post-op inflammation and endothelial cell change at six weeks after the procedure was evaluated. Surgeon's feedback was recorded to evaluate the cooperation of the patient during surgery. Results A total of 210 subjects were screened and 184 were randomized to have 92 subjects in each group. There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10). Subjects in Group A fared better when compared to Group B with respect to endothelial cell loss (P = 0.0008), and augmentation in mydriasis (P < 0.001). Conclusion Intracameral Ropivacaine and Lignocaine, both are equally effective in providing analgesia during phacoemulsification. However, intracameral Ropivacaine is superior to Lignocaine with regards to corneal endothelial cell safety, and augmenting mydriasis.",2020,"There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10).","['subjects undergoing phacoemulsification under augmented topical anesthesia', 'A total of 210 subjects were screened and 184 were randomized to have 92 subjects in each group']","['intracameral ropivacaine vs. lignocaine', 'Ropivacaine', 'Lignocaine', 'topical anesthesia', 'phacoemulsification with posterior chamber intraocular lens implantation', 'intracameral Ropivacaine', 'Group A (Ropivacaine 0.1%) or Group B (Lignocaine']","['efficacy and safety', 'visual analog scale scores', 'corneal endothelial cell safety', 'average ultrasound time', 'augmentation in mydriasis', 'painful surgical steps', 'endothelial cell loss', 'postoperative inflammation', ""surgeon's score""]","[{'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1298763', 'cui_str': 'Implantation of posterior chamber intraocular lens'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",210.0,0.040708,"There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10).","[{'ForeName': 'Arun K', 'Initials': 'AK', 'LastName': 'Sharma', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Hansraj', 'Affiliation': 'Mansarovar Eye Hospital, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ajai K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Jan Kalyan Eye Hospital, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Katiyar', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Sanjiv K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1388_19'] 3325,31916890,Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer.,"BACKGROUND A recently published randomized controlled trial compared single-dose psilocybin with single-dose niacin in conjunction with psychotherapy in participants with cancer-related psychiatric distress. Results suggested that psilocybin-assisted psychotherapy facilitated improvements in psychiatric and existential distress, quality of life, and spiritual well-being up to seven weeks prior to the crossover. At the 6.5-month follow-up, after the crossover, 60-80% of participants continued to meet criteria for clinically significant antidepressant or anxiolytic responses. METHODS The present study is a long-term within-subjects follow-up analysis of self-reported symptomatology involving a subset of participants that completed the parent trial. All 16 participants who were still alive were contacted, and 15 participants agreed to participate at an average of 3.2 and 4.5 years following psilocybin administration. RESULTS Reductions in anxiety, depression, hopelessness, demoralization, and death anxiety were sustained at the first and second follow-ups. Within-group effect sizes were large. At the second (4.5 year) follow-up approximately 60-80% of participants met criteria for clinically significant antidepressant or anxiolytic responses. Participants overwhelmingly (71-100%) attributed positive life changes to the psilocybin-assisted therapy experience and rated it among the most personally meaningful and spiritually significant experiences of their lives. CONCLUSION These findings suggest that psilocybin-assisted psychotherapy holds promise in promoting long-term relief from cancer-related psychiatric distress. Limited conclusions, however, can be drawn regarding the efficacy of this therapy due to the crossover design of the parent study. Nonetheless, the present study adds to the emerging literature base suggesting that psilocybin-facilitated therapy may enhance the psychological, emotional, and spiritual well-being of patients with life-threatening cancer.",2020,"Participants overwhelmingly (71-100%) attributed positive life changes to the psilocybin-assisted therapy experience and rated it among the most personally meaningful and spiritually significant experiences of their lives. ","['participants with cancer-related psychiatric distress', 'patients with life-threatening cancer', 'All 16 participants who were still alive were contacted, and 15 participants agreed to participate at an average of 3.2 and 4.5 years following psilocybin administration']","['psilocybin with single-dose niacin', 'psilocybin-assisted psychotherapy']","['anxiety, depression, hopelessness, demoralization, and death anxiety', 'psychiatric and existential distress, quality of life, and spiritual well-being']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0033850', 'cui_str': 'Psilocybin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0233498', 'cui_str': 'Demoralization (finding)'}, {'cui': 'C0522179', 'cui_str': 'Fear of death (finding)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034380'}]",16.0,0.11798,"Participants overwhelmingly (71-100%) attributed positive life changes to the psilocybin-assisted therapy experience and rated it among the most personally meaningful and spiritually significant experiences of their lives. ","[{'ForeName': 'Gabrielle I', 'Initials': 'GI', 'LastName': 'Agin-Liebes', 'Affiliation': 'Palo Alto University, Palo Alto, CA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Malone', 'Affiliation': 'NYU Psychedelic Research Group, New York, NY, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Yalch', 'Affiliation': 'Palo Alto University, Palo Alto, CA, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Mennenga', 'Affiliation': 'NYU Psychedelic Research Group, New York, NY, USA.'}, {'ForeName': 'K Linnae', 'Initials': 'KL', 'LastName': 'Ponté', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Guss', 'Affiliation': 'NYU Psychedelic Research Group, New York, NY, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Bossis', 'Affiliation': 'NYU Psychedelic Research Group, New York, NY, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Grigsby', 'Affiliation': 'Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ross', 'Affiliation': 'NYU Psychedelic Research Group, New York, NY, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119897615'] 3326,31342840,Prebiotic supplementation does not affect reading and cognitive performance in children: A randomised placebo-controlled study.,"Based on the emerging interest in the effects of gut microbiota on cognition, this proof-of-concept study assessed how children aged 7 to 9 with low reading scores responded to the ingestion of a 3-month prebiotic supplement versus a placebo. As a secondary aim, the effects of the prebiotic on cognition, sleep, behaviour, mood, anxiety, and cortisol were assessed. In this sample, the prebiotic did not affect any of the outcome measures.",2020,"In this sample, the prebiotic did not affect any of the outcome measures.","['children', 'children aged 7 to 9 with low reading scores']","['Prebiotic supplementation', 'placebo']","['reading and cognitive performance', 'cognition, sleep, behaviour, mood, anxiety, and cortisol']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0832234,"In this sample, the prebiotic did not affect any of the outcome measures.","[{'ForeName': 'Liliana P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Baião', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hee K', 'Initials': 'HK', 'LastName': 'Baek', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sharman', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher-James', 'Initials': 'CJ', 'LastName': 'Harvey', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Montgomery', 'Affiliation': 'Department of Social Policy, Sociology and Criminology, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Philip Wj', 'Initials': 'PW', 'LastName': 'Burnet', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119862534'] 3327,31978933,"Detection of acute 3,4-methylenedioxymethamphetamine (MDMA) effects across protocols using automated natural language processing.","The detection of changes in mental states such as those caused by psychoactive drugs relies on clinical assessments that are inherently subjective. Automated speech analysis may represent a novel method to detect objective markers, which could help improve the characterization of these mental states. In this study, we employed computer-extracted speech features from multiple domains (acoustic, semantic, and psycholinguistic) to assess mental states after controlled administration of 3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin. The training/validation set comprised within-participants data from 31 healthy adults who, over four sessions, were administered MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo in randomized, double-blind fashion. Participants completed two 5-min speech tasks during peak drug effects. Analyses included group-level comparisons of drug conditions and estimation of classification at the individual level within this dataset and on two independent datasets. Promising classification results were obtained to detect drug conditions, achieving cross-validated accuracies of up to 87% in training/validation and 92% in the independent datasets, suggesting that the detected patterns of speech variability are associated with drug consumption. Specifically, we found that oxytocin seems to be mostly driven by changes in emotion and prosody, which are mainly captured by acoustic features. In contrast, mental states driven by MDMA consumption appear to manifest in multiple domains of speech. Furthermore, we find that the experimental task has an effect on the speech response within these mental states, which can be attributed to presence or absence of an interaction with another individual. These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.",2020,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"['31 healthy adults who, over four sessions, were administered']","['placebo', 'MDMA', '3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin', 'oxytocin']",[],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],31.0,0.130727,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Agurto', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Guillermo A', 'Initials': 'GA', 'LastName': 'Cecchi', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA. gcecchi@us.ibm.com.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Norel', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ostrand', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Baggott', 'Affiliation': 'Addiction and Pharmacology Research Laboratory, Friends Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Wardle', 'Affiliation': 'Department of Psychology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet de', 'Initials': 'H', 'LastName': 'Wit', 'Affiliation': 'Human Behavioral Pharmacology Laboratory, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Gillinder', 'Initials': 'G', 'LastName': 'Bedi', 'Affiliation': 'Centre for Youth Mental Health, University of Melbourne, and Orygen National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0620-4'] 3328,32023526,Randomized Trial of a Smartphone Mobile App to Improve Symptoms and Adherence to Oral Therapy for Cancer.,"BACKGROUND Patients with cancer are increasingly prescribed oral therapies, bearing greater responsibility for self-management of treatment adherence and adverse events. We conducted a randomized trial to test the use of a smartphone mobile app to improve symptoms and adherence to oral cancer therapy. MATERIALS AND METHODS From February 18, 2015, through December 31, 2016, 181 patients with diverse cancers who were prescribed oral therapy were randomized to receive either the smartphone mobile app or standard care. The mobile app included a medication plan with reminders, a symptom-reporting module, and patient education. Primary outcomes were adherence (per electronic pill caps), symptom burden (per MD Anderson Symptom Inventory), and quality of life (per the Functional Assessment of Cancer Therapy-General). Participants also completed self-report measures of medication adherence, anxiety and depression symptoms, social support, quality of care, and healthcare utilization. Linear regression was used to assess intervention effects on adherence and change in self-report outcomes from baseline to week 12, controlling for baseline scores and social support. RESULTS Study groups did not differ across any outcome measure, with an overall mean adherence of 78.81% (SD, 26.66%) per electronic pill caps. However, moderation analyses showed that intervention effects on the primary adherence measure varied by baseline self-reported adherence and anxiety symptoms. Specifically, adherence rates per electronic pill caps were higher in patients randomized to the mobile app versus standard care within the subsamples of patients who reported baseline adherence problems (mean difference, -22.30%; 95% CI, -42.82 to -1.78; P=.034) and elevated anxiety (mean difference, -16.08%; 95% CI, -31.74 to -0.41; P=.044). CONCLUSIONS Although the mobile app may not improve outcomes for all patients prescribed oral cancer therapy, the intervention may be beneficial for those with certain risk factors, such as difficulties with adherence or anxiety.",2020,"We conducted a randomized trial to test the use of a smartphone mobile app to improve symptoms and adherence to oral cancer therapy. ","['Cancer', 'From February 18, 2015, through December 31, 2016, 181 patients with diverse cancers who were prescribed oral therapy', 'Patients with cancer']","['Smartphone Mobile App', 'smartphone mobile app or standard care', 'smartphone mobile app']","['adherence (per electronic pill caps), symptom burden (per MD Anderson Symptom Inventory), and quality of life (per the Functional Assessment of Cancer Therapy-General', 'overall mean adherence', 'medication adherence, anxiety and depression symptoms, social support, quality of care, and healthcare utilization', 'adherence rates per electronic pill caps', 'elevated anxiety', 'adherence and anxiety symptoms']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0037438'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",181.0,0.136404,"We conducted a randomized trial to test the use of a smartphone mobile app to improve symptoms and adherence to oral cancer therapy. ","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, and.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital, and.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pensak', 'Affiliation': 'University of Colorado-Anschutz Medical Campus, Denver, Colorado.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Nisotel', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Fishbein', 'Affiliation': 'University of Colorado-Boulder, Boulder, Colorado.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'MacDonald', 'Affiliation': 'University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Ream', 'Affiliation': 'University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Walsh', 'Affiliation': 'Massachusetts General Hospital, and.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Buzaglo', 'Affiliation': 'Concerto HealthAI, Boston, Massachusetts; and.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'Massachusetts General Hospital, and.'}, {'ForeName': 'Inga T', 'Initials': 'IT', 'LastName': 'Lennes', 'Affiliation': 'Massachusetts General Hospital, and.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'University of Miami, Coral Gables, Florida.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2019.7354'] 3329,32019847,Role of nocturnal light intensity on adaptation to three consecutive night shifts: a counterbalanced crossover study.,"OBJECTIVES To investigate how a standard ceiling mounted light-emitting diode (LED)-based bright light intervention affected alertness and neurobehavioural performance during three consecutive simulated night shifts, and timing of circadian rhythm after the shifts. METHODS Twenty seven participants (20 females, 21.4±2.1 years; mean±SD) worked three consecutive night shifts (23:00-07:00) under a full-spectrum (4000 K) bright light (900 lx) and a standard light (90 lx) condition in a counterbalanced crossover design (separated by 4 weeks). Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test) were assessed five times during each shift. Salivary dim-light melatonin onset (DLMO) was assessed before and after the shifts. The simulated night shifts were conducted in a laboratory while the participants slept at home. RESULTS Subjective alertness and neurobehavioural performance deteriorated during the night shifts in both light conditions. However, bright light significantly reduced alertness and performance decrements as compared with standard light. For a subset of the participants, DLMO was delayed by a mean of 3:17±0:23 (mean±SEM) hours after three night shifts in bright light and by 2:06±0:15 hours in standard light, indicating that bright light causes larger phase delay. CONCLUSION Bright light improved performance and alertness during simulated night shifts and improved adaptation to night work. Bright light administered by ceiling mounted LED luminaires has the potential to improve adaptation to night work and reduce the risk of accidents and injuries among night workers. TRIAL REGISTRATION NUMBER NCT03203538.",2020,Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test) were assessed five times during each shift.,"['Twenty seven participants (20 females, 21.4±2.1 years; mean±SD) worked three consecutive night shifts (23:00-07:00) under a']","['nocturnal light intensity', 'standard ceiling mounted light-emitting diode (LED)-based bright light intervention', 'full-spectrum (4000 K) bright light (900\u2009lx) and a standard light (90\u2009lx) condition']","['Salivary dim-light melatonin onset (DLMO', 'alertness and neurobehavioural performance', 'alertness and performance decrements', 'Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test', 'performance and alertness']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3876417', 'cui_str': 'Ceiling mount (physical object)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C1532530', 'cui_str': 'Full spectrum'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",27.0,0.0184987,Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test) were assessed five times during each shift.,"[{'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Sunde', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway erlend.sunde@uib.no.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Mrdalj', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Torhild', 'Initials': 'T', 'LastName': 'Pedersen', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Eirunn', 'Initials': 'E', 'LastName': 'Thun', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bjorvatn', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Waage', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106049'] 3330,31870492,Feasibility and Safety of Low-Dose Intra-Coronary Tenecteplase During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (ICE T-TIMI 49).,"Following primary percutaneous coronary intervention (PPCI) for ST segment elevation myocardial infarction, microvascular perfusion is often impaired secondary to thrombotic embolization. Intracoronary (IC) fibrinolytic administration may reduce thrombotic burden and distal embolization. The ICE-T-TIMI-49 study evaluated the feasibility and safety of low-dose IC tenecteplase (TNK) during PPCI. The study randomized 40 PPCI patients to a volume matched bolus of IC TNK (4 mg) (n = 20) or IC saline placebo (n = 20) before and following PPCI. The primary end point was percent diameter stenosis of the culprit lesion following first bolus. The primary end point did not differ between IC placebo (median 100%, interquartile range [IQR] 83.0,100.0) and IC TNK (median 100% stenosis, IQR 91.0,100.0; p = 0.522). However, the proportion of patients with reduction in thrombus following first bolus tended to be greater with IC TNK (placebo: 12.5% vs IC TNK: 40.0%, p = 0.133). Following PPCI, the corrected Thrombolysis In Myocardial Infarction (TIMI) frame count (cTFC) was lower (faster) with placebo (16.0 frames [IQR 12.0,24.0] vs 24.0 frames [22.0,32.0], p = 0.045) due to a trend towards greater frequency of hyperemia (cTFC <14), a marker of distal embolization (50.0% vs 8.3%, p = 0.056). There was no difference in TIMI major bleeds and no intracranial hemorrhage. In conclusion, treatment with low-dose IC TNK appears safe and well tolerated during PPCI. Although IC TNK administration did not improve percent stenosis, a trend towards reduced thrombus burden was demonstrated with less hyperemia (a marker of distal embolization). Our findings provide support for a large randomized study.",2020,"Following PPCI, the corrected Thrombolysis In Myocardial Infarction (TIMI) frame count (cTFC) was lower (faster) with placebo (16.0 frames [IQR 12.0,24.0] vs 24.0 frames [22.0,32.0], p = 0.045) due to a trend towards greater frequency of hyperemia (cTFC <14), a marker of distal embolization (50.0% vs 8.3%, p = 0.056).","['ST-Elevation Myocardial Infarction', '40 PPCI patients to a volume matched bolus of IC TNK (4\xa0mg) (n\u202f=\u202f20) or']","['Intracoronary (IC) fibrinolytic administration', 'IC TNK (placebo', 'IC placebo', 'IC saline placebo', 'low-dose IC tenecteplase (TNK', 'Low-Dose Intra-Coronary Tenecteplase', 'placebo', 'primary percutaneous coronary intervention (PPCI']","['marker of distal embolization', 'thrombotic burden and distal embolization', 'frequency of hyperemia', 'TIMI major bleeds and no intracranial hemorrhage', 'percent diameter stenosis of the culprit lesion', 'corrected Thrombolysis In Myocardial Infarction (TIMI) frame count (cTFC', 'safe and well tolerated']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0073807', 'cui_str': 'CTFE-Cys'}]",,0.229197,"Following PPCI, the corrected Thrombolysis In Myocardial Infarction (TIMI) frame count (cTFC) was lower (faster) with placebo (16.0 frames [IQR 12.0,24.0] vs 24.0 frames [22.0,32.0], p = 0.045) due to a trend towards greater frequency of hyperemia (cTFC <14), a marker of distal embolization (50.0% vs 8.3%, p = 0.056).","[{'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': ""Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts; TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: mgibson@bidmc.harvard.edu.""}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Priyamvada', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Kazziha', 'Affiliation': 'Cardiovascular Division, Crittenton Hospital Medical Center, Rochester, Michigan.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Devireddy', 'Affiliation': 'Cardiovascular Division, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'J Jeffrey', 'Initials': 'JJ', 'LastName': 'Marshall', 'Affiliation': 'Cardiovascular Division, Departments of Medicine, Northeast Georgia Heart Center, Gainesville, Georgia.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Stouffer', 'Affiliation': 'McAllister Heart Institute and Division of Cardiology, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': 'Cardiovascular Division, Departments of Medicine, Atlanta VA Medical Center, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Grip', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Bainey', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.018'] 3331,31125988,Using Nicotine Gum to Assist Nondaily Smokers in Quitting: A Randomized Clinical Trial.,"INTRODUCTION Non-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of nicotine gum, used to prevent or react to situational temptations, for helping ITS quit. METHODS ITS (smoking 4-27 days/month) seeking help quitting were randomized to 2 mg nicotine gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects. RESULTS Nicotine gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active gum and 5.3% for placebo (AOR = 1.39, 0.58-3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active gum on some outcomes. Gum use was low, starting at 1 gum per day on average and declining over time. CONCLUSIONS Nicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence. IMPLICATIONS Nicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS' smoking is motivated by nicotine-seeking, a theoretically and empirically derived situational approach to using acute nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence.",2020,"CONCLUSIONS Nicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence.","['ITS (smoking 4-27 days/month) seeking help quitting', 'daily smokers in quitting']","['nicotine', 'placebo', 'nicotine gum', 'nicotine gum (n=181) or placebo', 'Nicotine gum', 'behavioral counseling']","['6-month biochemically-verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing', 'continuous abstinence rates']","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0556971', 'cui_str': 'days/month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282218', 'cui_str': 'Analysis, Event History'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0153452,"CONCLUSIONS Nicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence.","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health & Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Primack', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz090'] 3332,31984514,Getting to the Heart of Low Sensitivity to Alcohol: Context Moderates Low Cardiovascular Response to Alcohol in Persons With a Family History of Alcohol Use Disorder.,"BACKGROUND Low sensitivity to alcohol in persons with a family history of alcoholism (FH+), compared to those without (FH-), contributes to risk for alcohol use disorder (AUD). However, sensitivity of FH+ cardiovascular response to alcohol is not well understood. This gap is significant because cardiovascular processes contribute to emotional regulation and stress response problems theorized to be central to the development and persistence of AUD. This study compared changes in heart rate (HR) and HR variability (HRV) between FH groups after consuming alcohol and control beverages and examined how these changes were moderated by emotional and alcohol-related contexts. METHODS Young adults (N = 165) with FH+ (n = 110) or FH- (n = 55) each completed 2 sessions, separated by 1 week. They received one of 3 different beverages (alcohol, placebo, and told-no-alcohol) in each session. Electrocardiogram data were recorded during pre-beverage consumption and post-beverage consumption baselines, and then during 4 picture cue tasks (neutral, positive, negative, and alcohol-related). Generalized estimating equations were used to examine differences in cardiovascular reactivity (changes in HR and HRV power at ~ 0.1 Hz) across FH groups, beverage conditions, and picture cue tasks. RESULTS A significant beverage condition × cue task × FH interaction effect on HRV was observed. The FH+ group, compared to the FH- group, showed (a) significantly less HRV suppression in specific cue contexts following alcohol, (b) a mixed pattern of more and less HRV suppression across cue contexts following placebo, and (c) a similar HRV reactivity pattern in the told-no-alcohol condition across cue tasks. For HR, there were no significant effects involving FH. CONCLUSIONS Diminished cardiovascular sensitivity to oral alcohol in FH+ persons varied within a given drinking episode depending on emotional and alcohol-related features of the context, suggesting that environmental characteristics play a role in the expression of low sensitivity to alcohol among FH+ individuals.",2020,"Generalized Estimating Equations were used to examine differences in cardiovascular reactivity (changes in HR and HRV power at ~0.1 Hz) across FH groups, beverage conditions, and picture cue tasks. ","['Young adults (N=165) with FH+ (n=110) or', 'FH+ persons', 'persons with a family history of alcoholism (FH', 'persons with a family history of alcohol use disorder']","['beverages (alcohol, placebo, told-no-alcohol', 'FH']","['HRV', 'Electrocardiogram data', 'heart rate (HR) and HR variability (HRV', 'beverage condition x cue task', 'cardiovascular reactivity (changes in HR and HRV power at ~0.1 Hz) across FH groups, beverage conditions, and picture cue tasks', 'HRV suppression']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",165.0,0.0301845,"Generalized Estimating Equations were used to examine differences in cardiovascular reactivity (changes in HR and HRV power at ~0.1 Hz) across FH groups, beverage conditions, and picture cue tasks. ","[{'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'From the, Division of Life Sciences, (MEB, JFB, EV, BV), Department of Kinesiology and Health, School of Arts and Sciences, Rutgers University - New Brunswick, New Brunswick, New Jersey.'}, {'ForeName': 'Eun-Young', 'Initials': 'EY', 'LastName': 'Mun', 'Affiliation': 'Department of Health Behavior and Health Systems, (E-YM), School of Public Health, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'From the, Division of Life Sciences, (MEB, JFB, EV, BV), Department of Kinesiology and Health, School of Arts and Sciences, Rutgers University - New Brunswick, New Brunswick, New Jersey.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Vaschillo', 'Affiliation': 'From the, Division of Life Sciences, (MEB, JFB, EV, BV), Department of Kinesiology and Health, School of Arts and Sciences, Rutgers University - New Brunswick, New Brunswick, New Jersey.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'From the, Division of Life Sciences, (MEB, JFB, EV, BV), Department of Kinesiology and Health, School of Arts and Sciences, Rutgers University - New Brunswick, New Brunswick, New Jersey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lehrer', 'Affiliation': 'Department of Psychiatry, (PL), Robert Wood Johnson Medical School, Rutgers University - New Brunswick, Piscataway, New Jersey.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Udo', 'Affiliation': 'Department of Health Policy, Management, and Behavior, (TU), School of Public Health, University at Albany- SUNY, Rensselaer, New York.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Lesnewich', 'Affiliation': 'Center of Alcohol and Substance Use Studies, (MEB, JFB, EV, BV, LML), Graduate School of Applied and Professional Psychology, Rutgers University - New Brunswick, Piscataway, New Jersey.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14293'] 3333,31494443,"The relative importance of perceived substance misuse use by different peers on smoking, alcohol and illicit drug use in adolescence.","BACKGROUND Substance use by young people is strongly associated with that of their peers. Little is known about the influence of different types of peers. We tested the relationship between perceived substance use by five types of peers and adolescents' use of illicit drugs, smoking, and alcohol consumption. METHODS We used data collected from 1285 students aged 12-13 as part of a pilot cluster randomized controlled trial (United Kingdom, 2014-2016). The exposures were the perceived use of illicit drugs, smoking and alcohol consumption by best friends, boy or girlfriends, brothers or sisters, friends outside of school and online. Outcomes were self-reported lifetime use of illicit drugs, smoking and alcohol consumption assessed 18-months later. RESULTS The lifetime prevalence of illicit drug use, smoking and alcohol consumption at the 18-month follow-up were 14.3%, 24.9% and 54.1%, respectively. In the fully adjusted models, perceived substance use by friends outside of school, brothers or sisters, and online had the most consistent associations with outcomes. Perceived use by friends online was associated with an increased risk of ever having used illicit drugs (odds ratio [OR] = 2.43, 95% confidence interval [CI] = 1.26, 4.69), smoking (OR = 1.61, 95% CI 0.96, 2.70) and alcohol consumption (OR = 2.98, 95% CI = 1.71, 5.18). CONCLUSIONS Perceived substance use by friends outside of school, brothers and sisters and online could be viable sources of peer influence. If these findings are replicated, a greater emphasis should be made in interventions to mitigate the influence of these peers.",2019,"Perceived use by friends online was associated with an increased risk of ever having used illicit drugs (odds ratio [OR] = 2.43, 95% confidence interval [CI] = 1.26, 4.69), smoking (OR = 1.61, 95% CI 0.96, 2.70) and alcohol consumption (OR = 2.98, 95% CI = 1.71, 5.18). ","['1285 students aged 12-13\u202fas part of a pilot cluster randomized controlled trial (United Kingdom, 2014-2016']",[],"['alcohol consumption', 'risk of ever having used illicit drugs', 'lifetime prevalence of illicit drug use, smoking and alcohol consumption', 'self-reported lifetime use of illicit drugs, smoking and alcohol consumption assessed 18-months later']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0281875', 'cui_str': 'Illicit drug use (finding)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.049883,"Perceived use by friends online was associated with an increased risk of ever having used illicit drugs (odds ratio [OR] = 2.43, 95% confidence interval [CI] = 1.26, 4.69), smoking (OR = 1.61, 95% CI 0.96, 2.70) and alcohol consumption (OR = 2.98, 95% CI = 1.71, 5.18). ","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Er', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, United Kingdom. Electronic address: Vanessa.Er@lshtm.ac.uk.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol. Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, United Kingdom. Electronic address: Rona.Campbell@bristol.ac.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hickman', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol. Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, United Kingdom. Electronic address: Matthew.Hickman@bristol.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, United Kingdom. Electronic address: Chris.Bonell@lshtm.ac.uk.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow, G2 3QB, United Kingdom. Electronic address: Laurence.Moore@glasgow.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, 4th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, United Kingdom. Electronic address: WhiteJ11@cardiff.ac.uk.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.04.035'] 3334,30632918,Emotion and decision-making: Induced mood influences IGT scores and deck selection strategies.,"The somatic marker hypothesis (SMH) represents a rich neuropsychological framework to study emotion-based decision-making. It originates from early brain lesion studies using the Iowa Gambling Task (IGT), which showed that adaptive decision-making relies on intact ventromedial prefrontal cortex for the integration of so-called ""hot"" affective signals and rational ""cold"" perceptual cognitive computations. Subsequent studies over the past 20 years have provided converging evidence for the reliability and validity of the IGT in assessing decision-making in both healthy and clinical samples, although some discrepancies remain. In healthy individuals, it has been shown that differences in emotional states prior to taking the IGT result in different outcomes, thus potentially accounting for some of the variation within this group. However, the precise role of such transient modulations of emotional states remains unclear. In this study we sought to examine the role of specific induced moods under carefully controlled conditions. Accordingly, we randomly assigned 44 healthy college undergraduates to a positive, negative, or neutral affect condition in which they simultaneously viewed images and listened to music that previous studies had shown to induce specific moods. Results indicated that mood induction was successful, and the positive affect group showed a clearly different pattern of IGT performance compared to the other two groups, in that they showed a rapidly established and stable bias favoring the positive expected value (EV) card decks. The negative affect group showed significantly lower bias towards the positive EV decks, although this group was not different from the neutral affect group. Bayesian analyses confirmed these findings. While consistent with SMH, these current findings may be best understood in support of a more general effect of normal mood on cognition as outlined in the broaden-and-build theory of positive emotions.",2019,"The negative affect group showed significantly lower bias towards the positive EV decks, although this group was not different from the neutral affect group.","['44 healthy college undergraduates', 'healthy individuals']",[],"['positive EV decks', 'IGT performance']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",44.0,0.03395,"The negative affect group showed significantly lower bias towards the positive EV decks, although this group was not different from the neutral affect group.","[{'ForeName': 'Mohinish', 'Initials': 'M', 'LastName': 'Shukla', 'Affiliation': 'a Department of Psychology , University of Massachusetts Boston , Boston , MA , USA.'}, {'ForeName': 'Eileen C', 'Initials': 'EC', 'LastName': 'Rasmussen', 'Affiliation': 'a Department of Psychology , University of Massachusetts Boston , Boston , MA , USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Nestor', 'Affiliation': 'a Department of Psychology , University of Massachusetts Boston , Boston , MA , USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2018.1562049'] 3335,31893580,Lipoprotein(a) Reduction in Persons with Cardiovascular Disease.,"BACKGROUND Lipoprotein(a) levels are genetically determined and, when elevated, are a risk factor for cardiovascular disease and aortic stenosis. There are no approved pharmacologic therapies to lower lipoprotein(a) levels. METHODS We conducted a randomized, double-blind, placebo-controlled, dose-ranging trial involving 286 patients with established cardiovascular disease and screening lipoprotein(a) levels of at least 60 mg per deciliter (150 nmol per liter). Patients received the hepatocyte-directed antisense oligonucleotide AKCEA-APO(a)-L Rx , referred to here as APO(a)-L Rx (20, 40, or 60 mg every 4 weeks; 20 mg every 2 weeks; or 20 mg every week), or saline placebo subcutaneously for 6 to 12 months. The lipoprotein(a) level was measured with an isoform-independent assay. The primary end point was the percent change in lipoprotein(a) level from baseline to month 6 of exposure (week 25 in the groups that received monthly doses and week 27 in the groups that received more frequent doses). RESULTS The median baseline lipoprotein(a) levels in the six groups ranged from 204.5 to 246.6 nmol per liter. Administration of APO(a)-L Rx resulted in dose-dependent decreases in lipoprotein(a) levels, with mean percent decreases of 35% at a dose of 20 mg every 4 weeks, 56% at 40 mg every 4 weeks, 58% at 20 mg every 2 weeks, 72% at 60 mg every 4 weeks, and 80% at 20 mg every week, as compared with 6% with placebo (P values for the comparison with placebo ranged from 0.003 to <0.001). There were no significant differences between any APO(a)-L Rx dose and placebo with respect to platelet counts, liver and renal measures, or influenza-like symptoms. The most common adverse events were injection-site reactions. CONCLUSIONS APO(a)-L Rx reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease. (Funded by Akcea Therapeutics; ClinicalTrials.gov number, NCT03070782.).",2020,Rx reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease.,"['286 patients with established cardiovascular disease and screening lipoprotein(a) levels of at least 60 mg per deciliter (150 nmol per liter', 'Persons with Cardiovascular Disease', 'patients who had elevated lipoprotein(a) levels and established cardiovascular disease']","['APO(a)-L', 'placebo', 'APO(a)-L Rx', 'saline placebo', 'hepatocyte-directed antisense oligonucleotide AKCEA-APO(a)-L Rx , referred to here as APO(a)-L Rx']","['median baseline lipoprotein(a) levels', 'lipoprotein(a) level', 'percent change in lipoprotein(a) level', 'platelet counts, liver and renal measures, or influenza-like symptoms', 'lipoprotein(a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0227525', 'cui_str': 'Hepatic Cells'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0079925', 'cui_str': 'Anti-Sense Oligonucleotides'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms (finding)'}]",286.0,0.410757,Rx reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease.,"[{'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Karwatowska-Prokopczuk', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Gouni-Berthold', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Steinhagen-Thiessen', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Shapiro', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Erik S', 'Initials': 'ES', 'LastName': 'Stroes', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Børge G', 'Initials': 'BG', 'LastName': 'Nordestgaard', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Guerriero', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Viney', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': ""O'Dea"", 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1905239'] 3336,32075845,Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study).,"INTRODUCTION Hand osteoarthritis (HOA) is a highly prevalent disabling joint disease. The current management regimens are limited. Potentially as a consequence, many people turn to complementary and alternative medicines for symptomatic relief. A combination of two or more supplements is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to investigate the efficacy of a supplement combination for treating symptomatic HOA in comparison to placebo. METHODS AND ANALYSIS The RADIANT study is an internet-based, parallel, superiority, double-blind, placebo-controlled, randomised, two-arm clinical trial. A participatory design is used to facilitate the study procedures. One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing Boswellia serrata extract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo for 12 weeks. The primary outcome will be 12-week change in hand pain on a visual analogue scale (VAS). Main secondary outcomes include adverse events, change in hand function, patient global assessment of disease activity and quality of life. A range of additional measures will be recorded, and an individual patient placebo response will be performed. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored weekly throughout the study. ETHICS AND DISSEMINATION This protocol has been approved by the University of Sydney Human Research Ethics Committee (HREC No. 2018/766). Dissemination will occur through conferences, social media, scientific publications and PhD thesis. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results.",2020,One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing ,"['hand osteoarthritis pain', 'One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2']","['placebo', 'supplement combination', 'Boswellia serrata extract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo', 'supplement combination composed of: (1) combined supplement containing']","['12-week change in hand pain on a visual analogue scale (VAS', 'Efficacy and safety', 'adverse events, change in hand function, patient global assessment of disease activity and quality of life', 'Adverse events']","[{'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0649652', 'cui_str': 'Benzenamine, 4-(hexyloxy)-'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2608032', 'cui_str': 'Boswellia serrata'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0872909', 'cui_str': 'pine bark extract'}, {'cui': 'C0058231', 'cui_str': 'dimethyl sulfone'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0239833', 'cui_str': 'Hand pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}]",106.0,0.623007,One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing ,"[{'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Robbins', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Eyles', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Fedorova', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Virk', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leticia A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McLachlan', 'Affiliation': 'School of Pharmacy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hunter', 'Affiliation': 'Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute of Medical Research, Rheumatology Department, Royal North Shore Hospital, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia david.hunter@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-035672'] 3337,32150151,Transcranial direct current stimulation effects on hand sensibility as measured by an objective quantitative analysis device: a randomized single-blind sham-control crossover clinical trial.,"Studies show that transcranial direct current stimulation (tDCS) can modulate somatosensory processing, but optimum parameters for tDCS effects on hand sensibility remain in question. We aimed to test the effects of anodal tDCS (atDCS) and cathodal tDCS (ctDCS) compared with sham tDCS (stDCS) of primary motor (M1) and sensory (S1) cortices on healthy subjects' hand sensibility. In this single-blind clinical trial, 30 randomized healthy volunteers received six tDCS sessions over 6 weeks: one session each of atDCS, ctDCS and stDCS over M1, and one session each of atDCS, ctDCS and stDCS over S1. Current perception threshold (CPT) was assessed using an objective quantitative analysis device (PainVision) at baseline, immediately (T0) and 30 min (T30) after each intervention. Our results showed that both atDCS and ctDCS of S1 and M1 significantly increased CPT. M1 ctDCS at T30 had the greatest effect of all M1 and S1 stimulation conditions (mean difference: 32.94%, Z: 3.12, effect size: 1.82, P < 0.001 The largest effect at S1 was for atDCS at T30 (mean difference: 29.87%, Z: 2.53, effect size: 1.72, P < 0.001. Our results are consistent with tDCS' modulatory effects on hand sensation, especially M1 ctDCS and S1 atDCS.",2020,"M1 ctDCS at T30 had the greatest effect of all M1 and S1 stimulation conditions (mean difference: 32.94%, Z: 3.12, effect size: 1.82, P < 0.001 The largest effect at S1 was for atDCS at T30 (mean difference: 29.87%, Z: 2.53, effect size: 1.72, P < 0.001.","['30 randomized healthy volunteers', ""healthy subjects' hand sensibility""]","['atDCS, ctDCS and stDCS over M1, and one session each of atDCS, ctDCS and stDCS over S1', 'transcranial direct current stimulation (tDCS', 'sham tDCS (stDCS) of primary motor (M1) and sensory (S1) cortices', 'Transcranial direct current stimulation', 'anodal tDCS (atDCS) and cathodal tDCS (ctDCS', 'six tDCS sessions', 'Current perception threshold (CPT']","['CPT', 'M1 and S1 stimulation conditions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}]","[{'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",30.0,0.214518,"M1 ctDCS at T30 had the greatest effect of all M1 and S1 stimulation conditions (mean difference: 32.94%, Z: 3.12, effect size: 1.82, P < 0.001 The largest effect at S1 was for atDCS at T30 (mean difference: 29.87%, Z: 2.53, effect size: 1.72, P < 0.001.","[{'ForeName': 'Hanan Ibrahim', 'Initials': 'HI', 'LastName': 'Zehry', 'Affiliation': 'Department of Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Maaty', 'Affiliation': 'Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, Suez Canal University Hospital, Ismailia, Egypt.'}, {'ForeName': 'Mirret M', 'Initials': 'MM', 'LastName': 'El-Hagrassy', 'Affiliation': 'Spaulding Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ueda', 'Affiliation': 'Department of Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kurumadani', 'Affiliation': 'Department of Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Spaulding Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sunagawa', 'Affiliation': 'Department of Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",Neuroreport,['10.1097/WNR.0000000000001423'] 3338,31771385,Child Caries Management: A Randomized Controlled Trial in Dental Practice.,"This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co-primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).",2020,There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P.,"['1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis', 'Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion', 'Child Caries Management', '3 y for managing dental caries in primary teeth in UK primary dental care', 'participants with at least 1 episode of dental pain and/or infection were as follows']","['centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants', 'C+P']","['incidence or number of episodes of dental pain and/or infection', 'incidence of dental pain and/or infection', 'proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection', 'mean (SD) number of episodes of dental pain and/or infection']","[{'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1144.0,0.369859,There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P.,"[{'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Innes', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'G V A', 'Initials': 'GVA', 'LastName': 'Douglas', 'Affiliation': 'School of Dentistry, University of Leeds, Leeds, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Homer', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Marshman', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abouhajar', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Holmes', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chadwick', 'Affiliation': 'School of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deery', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Institute of Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.'}]",Journal of dental research,['10.1177/0022034519888882'] 3339,31636172,Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors.,"Coronary artery disease (CAD) is more frequent among individuals with dysglycemia. Preventive interventions for diabetes can improve cardiometabolic risk factors (CRFs), but it is unclear whether the benefits on CRFs are similar for individuals at different genetic risk for CAD. We built a 201-variant polygenic risk score (PRS) for CAD and tested for interaction with diabetes prevention strategies on 1-year changes in CRFs in 2,658 Diabetes Prevention Program (DPP) participants. We also examined whether separate lifestyle behaviors interact with PRS and affect changes in CRFs in each intervention group. Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared with placebo ( P < 0.001) irrespective of CAD genetic risk ( P interaction > 0.05). We detected nominal significant interactions between PRS and dietary quality and physical activity on 1-year change in BMI, fasting glucose, triglycerides, and HDL cholesterol in individuals randomized to metformin or placebo, but none of them achieved the multiple-testing correction for significance. This study confirms that diabetes preventive interventions improve CRFs regardless of CAD genetic risk and delivers hypothesis-generating data on the varying benefit of increasing physical activity and improving diet on intermediate cardiovascular risk factors depending on individual CAD genetic risk profile.",2020,Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared to placebo ( P <0.001) irrespective of CAD genetic risk ( P int >0.05).,"['2,658 Diabetes Prevention Program participants', 'individuals with dysglycemia']","['placebo', 'metformin']","['CAD genetic risk', 'majority of recognized CRFs', 'Coronary artery disease (CAD', 'PRS and dietary quality and physical activity on one-year change in body mass index, fasting glucose, triglycerides, and HDLc']","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",2658.0,0.0257923,Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared to placebo ( P <0.001) irrespective of CAD genetic risk ( P int >0.05).,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Merino', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Jablonski', 'Affiliation': 'The Biostatistics Center, Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Mercader', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Maegan', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Genomics Platform, Eli and Edythe L. Broad Institute of MIT and Harvard, Cambridge, MA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Maria Rosario G', 'Initials': 'MRG', 'LastName': 'Araneta', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Walford', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Suzanne B R', 'Initials': 'SBR', 'LastName': 'Jacobs', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Uzoma N', 'Initials': 'UN', 'LastName': 'Ibebuogu', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, The University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Genetic & Molecular Epidemiology Unit, Lund University Diabetes Centre, Malmo, Sweden.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Florez', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0097'] 3340,31599044,Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates.,"OBJECTIVE To compare the outcomes of Aquablation in 30-80 mL prostates with those in 80-150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume. PATIENTS AND METHODS Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W-I]; NCT02505919) is a prospective, double-blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W-II; NCT03123250) is a prospective, multicentre, single-arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12-month outcomes in 116 W-I and 101 W-II study patients. Students' t-test or Wilcoxon tests were used for continuous variables and Fisher's test for binary variables. RESULTS The mean (SD) operative time was 33 (17) and 37 (13) min in W-I and W-II, respectively. Actual treatment time was 4 and 8 min in W-I and W-II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W-I and 17.1 in W-II (P = 0.605). By 3 months, Clavien-Dindo grade ≥II events occurred in 19.8% of W-I patients and 34.7% of W-II patients (P = 0.468). CONCLUSION Aquablation clinically normalises outcomes between patients with 30-80 mL prostates and patients with 80-150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long-term outcomes of procedure durability are needed.",2020,"Mean operative time was 33±17 and 37±13 minutes, in W-I and W-II respectively.","['Benign Prostatic Hyperplasia in 30cc-80cc and 80cc-150cc Prostates', 'prostates between 80cc and 150cc', 'LUTS/BPH in prostates between 30cc and 80cc']","['Aquablation Therapy', 'LUTS/BPH', 'TURP']","['Mean change in IPSS', 'Mean operative time', 'risk of complication', 'Clavien-Dindo grade 2 or higher events']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",116.0,0.0656155,"Mean operative time was 33±17 and 37±13 minutes, in W-I and W-II respectively.","[{'ForeName': 'David-Dan', 'Initials': 'DD', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barber', 'Affiliation': 'Frimley Park Hospital, Urology, Frimley, Surrey, UK.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Bidair', 'Affiliation': 'San Diego Clinical Trials, San Diego, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gilling', 'Affiliation': 'Bay of Plenty District Health Board Clinical School, Urology, Tauranga, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'Royal Melbourne Hospital, Urology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Zorn', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Division of Urology, Montreal, QC, Canada.""}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Badlani', 'Affiliation': 'Wake Forest School of Medicine, Urology, Winston-Salem, NC, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Humphreys', 'Affiliation': 'Mayo Clinic, Department of Urology, Phoenix, AZ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kaplan', 'Affiliation': 'Department of Urology, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Kaufman', 'Affiliation': 'Division of Urology, Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'So', 'Affiliation': 'University of British Columbia, Urologic Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Paterson', 'Affiliation': 'University of British Columbia, Urologic Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Goldenberg', 'Affiliation': 'University of British Columbia, Urologic Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Elterman', 'Affiliation': 'Division of Urology, University of Toronto, Montréal, QC, Canada.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'USC Institute of Urology, University of Southern California, Urology, Los Angeles, CA, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Lingeman', 'Affiliation': 'Institute for Kidney Stone Disease, Methodist Hospital, Indianapolis, IN, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Roehrborn', 'Affiliation': 'UT Southwestern Medical Centre, Urology, Dallas, TX, USA.'}, {'ForeName': 'Naeem', 'Initials': 'N', 'LastName': 'Bhojani', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Division of Urology, Montreal, QC, Canada.""}]",BJU international,['10.1111/bju.14917'] 3341,31909680,Effects of acute cannabidiol administration on anxiety and tremors induced by a Simulated Public Speaking Test in patients with Parkinson's disease.,"BACKGROUND Cannabidiol (CBD) is one of the main components of Cannabis sativa and has anxiolytic properties, but no study has been conducted to evaluate the effects of CBD on anxiety signs and symptoms in patients with Parkinson's disease (PD). This study aimed to evaluate the impacts of acute CBD administration at a dose of 300 mg on anxiety measures and tremors induced by a Simulated Public Speaking Test (SPST) in individuals with PD. METHODS A randomised, double-blinded, placebo-controlled, crossover clinical trial was conducted. A total of 24 individuals with PD were included and underwent two experimental sessions within a 15-day interval. After taking CBD or a placebo, participants underwent the SPST. During the test, the following data were collected: heart rate, systemic blood pressure and tremor frequency and amplitude. In addition, the Visual Analog Mood Scales (VAMS) and Self-Statements during Public Speaking Scale were applied. Statistical analysis was performed by repeated-measures analysis of variance (ANOVA) while considering the drug, SPST phase and interactions between these variables. RESULTS There were statistically significant differences in the VAMS anxiety factor for the drug; CBD attenuated the anxiety experimentally induced by the SPST. Repeated-measures ANOVA showed significant differences in the drug for the variable related to tremor amplitude as recorded by the accelerometer. CONCLUSION Acute CBD administration at a dose of 300 mg decreased anxiety in patients with PD, and there was also decreased tremor amplitude in an anxiogenic situation.",2020,There were statistically significant differences in the VAMS anxiety factor for the drug; CBD attenuated the anxiety experimentally induced by the SPST.,"['individuals with PD', '24 individuals with PD', ""patients with Parkinson's disease (PD"", ""patients with Parkinson's disease""]","['placebo', 'CBD', 'Simulated Public Speaking Test (SPST', 'acute cannabidiol administration']","['tremor amplitude', 'heart rate, systemic blood pressure and tremor frequency and amplitude', 'VAMS anxiety factor', 'Visual Analog Mood Scales (VAMS) and Self-Statements during Public Speaking Scale', 'anxiety']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0222045'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]",24.0,0.129145,There were statistically significant differences in the VAMS anxiety factor for the drug; CBD attenuated the anxiety experimentally induced by the SPST.,"[{'ForeName': 'Stephanie Martins', 'Initials': 'SM', 'LastName': 'de Faria', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Daiene', 'Initials': 'D', 'LastName': 'de Morais Fabrício', 'Affiliation': 'Department of Psychology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Tumas', 'Affiliation': 'Department of Neuroscience and Behavior, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Paula Costa', 'Initials': 'PC', 'LastName': 'Castro', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Moacir Antonelli', 'Initials': 'MA', 'LastName': 'Ponti', 'Affiliation': 'Institute of Mathematical and Computer Sciences, University of São Paulo, São Carlos, Brazil.'}, {'ForeName': 'Jaime Ec', 'Initials': 'JE', 'LastName': 'Hallak', 'Affiliation': 'Department of Neuroscience and Behavior, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Antonio W', 'Initials': 'AW', 'LastName': 'Zuardi', 'Affiliation': 'Department of Neuroscience and Behavior, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'José Alexandre S', 'Initials': 'JAS', 'LastName': 'Crippa', 'Affiliation': 'Department of Neuroscience and Behavior, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Marcos Hortes Nisihara', 'Initials': 'MHN', 'LastName': 'Chagas', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119895536'] 3342,31882530,Prevalence and correlates of periodic limb movements in OSA and the effect of CPAP therapy.,"OBJECTIVE We sought to assess the prevalence, correlates, and consequences of periodic limb movements of sleep (PLMS) in persons with obstructive sleep apnea (OSA) and the effect (worsening or improvement) of continuous positive airway pressure (CPAP) therapy on PLMS in a large prospective multicenter randomized controlled trial. METHODS We performed retrospective analyses of data from the Apnea Positive Pressure Long-term Efficacy Study, a prospective multicenter randomized controlled trial. A total of 1,105 persons with OSA enrolled in this study underwent a polysomnographic investigation at baseline, another one for CPAP titration, and another study 6 months after randomization to either active CPAP or sham CPAP. RESULTS Of all participants, 19.7% had PLM index (PLMI) ≥10/hour, 14.8% had PLMI ≥15/hour, 12.1% had PLMI ≥20/hour, 9.3% had PLMI ≥25/hour, and 7.5% had PLMI ≥30/hour. The odds of having a PLMI ≥10 were higher in older participants (odds ratio [OR] 1.03, p < 0.001), men (OR 1.63. p = 0.007), those using antidepressants (OR 1.48. p = 0.048), and those with higher caffeine use (OR 1.01, p = 0.04). After controlling for OSA and depression, PLMS were associated with increased sleep latency, reduced sleep efficiency, and reduced total sleep time. No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test). There was no differential effect of CPAP in comparison to sham CPAP on PLMS after 6 months of therapy. CONCLUSIONS PLMS are common in patients with OSA and are associated with a significant reduction in sleep quality over and above that conferred by OSA. Treatment with CPAP does not affect the severity of PLMS.",2020,No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test).,"['persons with obstructive sleep apnea (OSA', '1,105 persons with OSA enrolled', 'patients with OSA']","['continuous positive airway pressure (CPAP) therapy', 'active CPAP or sham CPAP', 'PLMI', 'CPAP therapy', 'periodic limb movements of sleep (PLMS', 'CPAP']","['PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test', 'sleep quality', 'PLM index', 'total sleep time', 'sleep latency, reduced sleep efficiency', 'severity of PLMS']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",1105.0,0.121071,No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test).,"[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Budhiraja', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson. rbudhiraja@bwh.harvard.edu.""}, {'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Milena K', 'Initials': 'MK', 'LastName': 'Pavlova', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Epstein', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Olabimpe', 'Initials': 'O', 'LastName': 'Omobomi', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Quan', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}]",Neurology,['10.1212/WNL.0000000000008844'] 3343,32026297,Comparison of 0.5% Centbucridine and 2% Lignocaine as Local Anesthetic Agents for Dental Procedures in Children: A Randomised Controlled Trial.,"OBJECTIVE To compare 0.5% centbucridine and 2% lignocaine (with adrenaline) as local anesthetic agents for dental treatment procedures in 12 to 14 y old children. METHODS A split mouth, triple blind randomised controlled trial design was adopted for this study. Fifty six children between 12 to 14 y of age requiring bilateral administration of inferior alveolar nerve block (IANB) were recruited for this study. The mandibular quadrants were randomly allotted to the drug being administered. Standardised protocol for local anesthesia administration was used. The primary outcomes assessed were onset, duration and depth of anesthesia using the pre-validated Visual Analog scale and effect on perioperative pulse rate using a pulse oximeter. RESULTS There was no significant difference between centbucridine and lignocaine with respect to their mean onset [(105.181 and 99.727 s respectively), (p = 0.647)], duration of action [(91.931 and 91.613 min respectively), (p = 0.931)] and depth of anesthesia at 10, 30 and 60 min. Centbucridine showed a statistically significant drop in the pulse rate at 10 (p < 0.001) and 30 min (p < 0.001). CONCLUSIONS There was no significant difference between 0.5% centbucridine and 2% lignocaine with respect to onset, duration and depth of anesthesia.",2020,"Centbucridine showed a statistically significant drop in the pulse rate at 10 (p < 0.001) and 30 min (p < 0.001). ","['Fifty six children between 12 to 14 y of age requiring bilateral administration of inferior alveolar nerve block (IANB', 'dental treatment procedures in 12 to 14 y old children', 'Dental Procedures in Children']","['Centbucridine and 2% Lignocaine', 'centbucridine and 2% lignocaine (with adrenaline', 'lignocaine']","['onset, duration and depth of anesthesia using the pre-validated Visual Analog scale and effect on perioperative pulse rate using a pulse oximeter', 'depth of anesthesia', 'duration of action', 'pulse rate', 'onset, duration and depth of anesthesia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block (procedure)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}]","[{'cui': 'C0055053', 'cui_str': 'centbucridine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia (observable entity)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter (physical object)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",56.0,0.0989203,"Centbucridine showed a statistically significant drop in the pulse rate at 10 (p < 0.001) and 30 min (p < 0.001). ","[{'ForeName': 'Nikhita Satish', 'Initials': 'NS', 'LastName': 'Gune', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, YMT Dental College and Hospital, Mumbai, Maharashtra, India. drnikhitagune@gmail.com.'}, {'ForeName': 'Amar Narayan', 'Initials': 'AN', 'LastName': 'Katre', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, YMT Dental College and Hospital, Mumbai, Maharashtra, India.'}]",Indian journal of pediatrics,['10.1007/s12098-019-03161-6'] 3344,32114466,"The INternet ThERapy for deprESsion Trial (INTEREST): protocol for a patient-preference, randomised controlled feasibility trial comparing iACT, iCBT and attention control among individuals with comorbid chronic pain and depression.","INTRODUCTION Approximately one-third of adults with chronic pain also report clinically relevant levels of depression. Internet-delivered psychological therapies such as Cognitive Behavioural Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) have been developed to overcome barriers of access to services and ensure the timely delivery of care. The objective of this trial is to collect data on feasibility, acceptability and range of probable effect sizes for iCBT and iACT interventions tailored towards the treatment of depression and chronic pain using a randomised controlled patient-preference design. METHODS AND ANALYSIS Community dwelling adults with chronic non-cancer pain (CNCP) and major depression will be recruited from pain clinics and primary care providers in Newfoundland and Labrador, Canada. The study is a randomised controlled patient-preference trial. Eligible patients will be randomly assigned to a 'preference' or 'no-preference' arm during the first step of randomisation and to intervention or control in the second step of randomisation. Two interventions (ie, iCBT or iACT) will be evaluated relative to attention control. iCBT and iACT involve the completion of 7-weekly online modules augmented with one session of motivational enhancement and weekly therapy sessions. Primary outcomes include (1) feasibility and acceptability parameters and (2) change in symptoms of depression. Secondary outcomes include pain, physical function, emotional function and quality of life. We will recruit 60 participants and examine the range of effect sizes obtained from the trial but will not conduct significance testing as per recommendations for behavioural trial development. ETHICS AND DISSEMINATION Ethics was approved by the provincial Health Research Ethics Board. Dissemination of results will be published in a peer-reviewed academic journal and presented at scientific conferences. TRIAL REGISTRATION NUMBER NCT04009135.",2020,Internet-delivered psychological therapies such as Cognitive Behavioural Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) have been developed to overcome barriers of access to services and ensure the timely delivery of care.,"['Eligible patients', 'Community dwelling adults with chronic non-cancer pain (CNCP) and major depression will be recruited from pain clinics and primary care providers in Newfoundland and Labrador, Canada', 'individuals with comorbid chronic pain and depression']","['Internet-delivered psychological therapies such as Cognitive Behavioural Therapy (iCBT) and Acceptance and Commitment Therapy (iACT', 'Two interventions (ie, iCBT or iACT', 'iCBT and iACT interventions', 'iCBT and iACT']","['1) feasibility and acceptability parameters and (2) change in symptoms of depression', 'pain, physical function, emotional function and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C1956182', 'cui_str': 'Newfoundland and Labrador'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0034380'}]",60.0,0.249745,Internet-delivered psychological therapies such as Cognitive Behavioural Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) have been developed to overcome barriers of access to services and ensure the timely delivery of care.,"[{'ForeName': 'Louise V', 'Initials': 'LV', 'LastName': 'Bell', 'Affiliation': ""Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cornish', 'Affiliation': ""Student Wellness & Counselling Centre, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Flusk', 'Affiliation': ""Anesthesia, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Rash', 'Affiliation': ""Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada jarash@mun.ca.""}]",BMJ open,['10.1136/bmjopen-2019-033350'] 3345,32047021,TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient-a feasibility study protocol.,"INTRODUCTION Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker. METHODS AND ANALYSIS The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial. ETHICS AND DISSEMINATION Ethical approval for the study was given by the South West-Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences. TRIAL REGISTRATION NUMBER ISRCTN10649958.",2020,"A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury.",['Participants will be recruited from major trauma centres'],"['TULIP', 'operative or non-operative management of their injuries', 'surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1']","['health-related quality of life, functional outcome and pain']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}]","[{'cui': 'C0331680', 'cui_str': 'Tulip'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.126724,"A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Barnfield', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK jenny.ingram@bristol.ac.uk.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Halliday', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Griffin', 'Affiliation': 'Nuffield Dept of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Greenwood', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Level 3 Education Centre, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Department of Anaesthetics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Glynn', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McArthur', 'Affiliation': 'Department of Orthopaedics, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bates', 'Affiliation': 'Department of Orthopaedics, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Mehool', 'Initials': 'M', 'LastName': 'Acharya', 'Affiliation': 'Department of Trauma & Orthopaedics, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036588'] 3346,32060166,Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors.,"INTRODUCTION Many breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors' optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors. METHODS AND ANALYSIS This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors' activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later. ETHICS AND DISSEMINATION Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03915548; Pre-results.",2020,"Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors. ","['Many breast cancer survivors', 'breast cancer survivors', 'Human Subjects at Dartmouth College', 'female breast cancer survivors', '300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham']","['rehabilitation intervention', 'nine-session BA and PST-informed rehabilitation intervention (BA/PS', 'rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST']",[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],300.0,0.0960632,"Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors. ","[{'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hegel', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Marie Anne', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Bruce', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Chamberlin', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Keene', 'Affiliation': 'Radiation Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Rocque', 'Affiliation': 'Medicine, Divisions of Hematology and Oncology, and Geriatrics, Gerontology, and Palliative Care, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Ellis', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Gilbert', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Jamme L', 'Initials': 'JL', 'LastName': 'Morency', 'Affiliation': 'Physical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Newman', 'Affiliation': 'Occupational Therapy, Boston University College of Health and Rehabilitation Sciences Sargent College, Boston, Massachusetts, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Codini', 'Affiliation': 'Physical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Thorp', 'Affiliation': 'Physical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Dos Anjos', 'Affiliation': 'Occupational Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Danielle Z', 'Initials': 'DZ', 'LastName': 'Cloyd', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Echols', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Milford', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Ingram', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Kathleen Doyle', 'Initials': 'KD', 'LastName': 'Lyons', 'Affiliation': 'Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA kathleen.d.lyons@dartmouth.edu.'}]",BMJ open,['10.1136/bmjopen-2020-036864'] 3347,32071190,Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson's disease-STARTUP.,"INTRODUCTION Parkinson's disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK. OBJECTIVES Conduct a randomised controlled trial (RCT) targeting people with Parkinson's disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS. METHODS AND ANALYSIS An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan ETHICS AND DISSEMINATION: East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences. TRIAL REGISTRATION NUMBER ISRCTN12437878; Pre-results.",2020,"Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK. ","[""urinary problems associated with Parkinson's disease-STARTUP"", ""people with Parkinson's disease (PwP) who have self-reported problematic lower urinary tract symptoms"", 'Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system']","['TTNS or sham TTNS', 'TTNS', 'transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS']","['effectiveness, safety, cost and acceptability', 'International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score', 'Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score', '3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation', 'Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence']","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4544471', 'cui_str': 'ICIQ-UI-SF- International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}]",,0.324276,"Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK. ","[{'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK doreen.mcclurg@gcu.ac.uk.'}, {'ForeName': 'Jalesh', 'Initials': 'J', 'LastName': 'Panicker', 'Affiliation': 'Department of Neurology, University College London, London, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Walker', 'Affiliation': 'Department of Medicine, North Tyneside General Hospital, North Shields, UK.'}, {'ForeName': 'AnneLouise', 'Initials': 'A', 'LastName': 'Cunnington', 'Affiliation': 'Neurology Department, Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde Clyde Division, Glasgow, UK.'}, {'ForeName': 'Katherine H O', 'Initials': 'KHO', 'LastName': 'Deane', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Harari', 'Affiliation': 'Department of Ageing and Health, Kings College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Booth', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Nursing Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mason', 'Affiliation': 'Yunus Centre, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Nursing Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034887'] 3348,32029499,Effect of once weekly folic acid supplementation on erythrocyte folate concentrations in women to determine potential to prevent neural tube defects: a randomised controlled dose-finding trial in Malaysia.,"INTRODUCTION Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs). Because these birth defects occur early in pregnancy, before women may know they are pregnant, many countries have mandated the addition of folic acid to food staples. In countries where fortification is not possible, and weekly iron folic acid programmes exist to reduce anaemia, the WHO recommends that 2.8 mg (7×0.4 mg) folic acid be given instead of the current weekly practice of 0.4 mg. Currently, there is a lack of evidence to support if the 2.8 mg folic acid per week dose is sufficient to raise erythrocyte folate concentrations to a level associated with a reduced risk of a NTD-affected pregnancy. We aim to conduct a three-arm randomised controlled trial to determine the effect of weekly folic acid with iron on erythrocyte folate, a biomarker of NTD risk. METHODS AND ANALYSIS We will recruit non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia. Women will be randomised to receive either 2.8, 0.4 or 0.0 (placebo) mg folic acid with 60 mg iron weekly for 16 weeks, followed by a 4-week washout period. The primary outcome will be erythrocyte folate concentration at 16 weeks and the mean concentration will be compared between randomised treatment groups (intention-to-treat) using a linear regression model adjusting for the baseline measure. ETHICS AND DISSEMINATION Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBERS ACTRN12619000818134 and NMRR-19-119-45736.",2020,"INTRODUCTION Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs).","['women to determine potential to prevent neural tube defects', 'non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia']","['Folic acid', 'folic acid', '0.0 (placebo) mg folic acid', 'folic acid supplementation']","['erythrocyte folate concentrations', 'erythrocyte folate concentration']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0027794', 'cui_str': 'Developmental Defects, Neural Tube'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.504137,"INTRODUCTION Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs).","[{'ForeName': 'Kaitlyn L I', 'Initials': 'KLI', 'LastName': 'Samson', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Su Peng', 'Initials': 'SP', 'LastName': 'Loh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Geok Lin', 'Initials': 'GL', 'LastName': 'Khor', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Zalilah', 'Initials': 'Z', 'LastName': 'Mohd Shariff', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Lisa N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Shalem', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Hutcheon', 'Affiliation': ""Healthy Starts, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Dian C', 'Initials': 'DC', 'LastName': 'Sulistyoningrum', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Yu', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Roche', 'Affiliation': 'Global Technical Services, Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'De-Regil', 'Affiliation': 'Global Technical Services, Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Green', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada Crystal.Karakochuk@ubc.ca.'}]",BMJ open,['10.1136/bmjopen-2019-034598'] 3349,31564599,"Cluster Randomized Trial of Teens Against Tobacco Use: Youth Empowerment for Tobacco Control in El Paso, Texas.","INTRODUCTION This study examines smoke-free youth partnerships implementing the Teens Against Tobacco Use model developed by the American Lung Association. This innovative tobacco prevention strategy has not been evaluated rigorously. Students used peer teaching to educate youth about tobacco use and engaged in tobacco control advocacy activities. Participating high school and middle school youth were trained to develop and deliver tobacco prevention presentations to 4th-8th grade students in schools. STUDY DESIGN To evaluate the efficacy of the presentations, matched pairs of classrooms willing to have 1 presentation were randomly assigned to receive either the presentation first (intervention condition) or later in the school year (control condition). SETTING/PARTICIPANTS The study took place in a predominantly low-income Hispanic community. A total of 9 schools, 107 classes, and 2,257 students participated in the evaluation. MAIN OUTCOME MEASURES Tobacco susceptibility was assessed with a brief survey administered to students in both intervention and control classrooms in 2014 and 2015 after the completion of presentations in intervention classrooms. Analyses completed in 2019 compared intervention and control classrooms on tobacco susceptibility. RESULTS Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility. Teens Against Tobacco Use presenters also completed tobacco retailer compliance checks and gained media coverage in advocating to regulate e-cigarettes in the same manner as other tobacco products. CONCLUSIONS Findings suggest Teens Against Tobacco Use is an effective means of reducing tobacco susceptibility among 4th-8th graders in the immediate term. Longer-term outcome evaluations are needed to determine whether Teens Against Tobacco Use presentations can have a lasting impact on tobacco use. TRIAL REGISTRATION This study is registered at www.clinicaltrials.gov NCT02443025.",2019,"RESULTS Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility.","['matched pairs of classrooms willing to have 1 presentation', 'A total of 9 schools, 107 classes, and 2,257 students participated in the evaluation', 'Teens Against Tobacco Use: Youth Empowerment for Tobacco Control in El Paso, Texas', 'Participating high school and middle school youth were trained to develop and deliver tobacco prevention presentations to 4th-8th grade students in schools', 'predominantly low-income Hispanic community']","['presentation first (intervention condition) or later in the school year (control condition', 'peer teaching to educate youth about tobacco use and engaged in tobacco control advocacy activities']","['tobacco susceptibility scores', 'tobacco susceptibility']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",107.0,0.0425585,"RESULTS Intent-to-treat analyses indicated that classrooms receiving a tobacco prevention presentation had significantly lower tobacco susceptibility scores than classrooms that did not receive a presentation (12% vs 17%, p<0.01), representing a 37% reduction in the odds of tobacco susceptibility.","[{'ForeName': 'Louis D', 'Initials': 'LD', 'LastName': 'Brown', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, University of Texas Health Science Center at Houston, School of Public Health, El Paso, Texas. Electronic address: louis.d.brown@uth.tmc.edu.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Bandiera', 'Affiliation': 'Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Harrell', 'Affiliation': 'Department of Epidemiology, Human Genetics, and Environmental Sciences, University of Texas Health Science Center at Houston, School of Public Health, Austin, Texas.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.06.013'] 3350,30579673,Determinants and the Role of Self-Efficacy in a Sodium-Reduction Trial in Hemodialysis Patients.,"OBJECTIVE This study was to assess the impact of baseline dietary self-efficacy on the effect of a dietary intervention to reduce sodium intake in patients undergoing hemodialysis (HD) and to identify determinants of low dietary self-efficacy. METHODS This is a post hoc analysis of the BalanceWise study, a randomized controlled trial that aimed to reduce dietary sodium intake in HD patients recruited from 17 dialysis centers in Pennsylvania. The main outcome measures include dietary self-efficacy and reported dietary sodium density. Analysis of variance with post hoc group-wise comparison was used to examine the effect of baseline dietary self-efficacy on changes in reported sodium density in the intervention and control groups at 8 and 16 weeks. Chi-square test, independent t tests, or Wilcoxon rank-sum tests were used to identify determinants of low dietary self-efficacy. RESULTS The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively). Younger age and perceived income inadequacy were significantly associated with low self-efficacy in patients undergoing HD. CONCLUSION The benefits of dietary interventions designed to improve self-efficacy may differ by the baseline self-efficacy status. This may be particularly important for HD patients who are younger and report inadequate income as they had lower dietary self-efficacy.",2019,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","['patients undergoing hemodialysis (HD', 'HD patients who are younger and report inadequate income', 'HD patients recruited from 17 dialysis centers in Pennsylvania', 'Hemodialysis Patients']",['dietary intervention'],"['self-efficacy', 'dietary self-efficacy and reported dietary sodium density']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",,0.0354234,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York. Electronic address: lu.hu@nyumc.org.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'St-Jules', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Collin J', 'Initials': 'CJ', 'LastName': 'Popp', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.10.006'] 3351,31793645,A Fortified Food Can Be Replaced by Micronutrient Supplements for Distribution in a Mexican Social Protection Program Based on Results of a Cluster-Randomized Trial and Costing Analysis.,"BACKGROUND Despite positive nutrition impacts, the prevalence of malnutrition among beneficiaries of Mexico's conditional cash transfer (CCT) program remains high. Greater nutrition impact may have been constrained by the type of nutritional supplements provided. OBJECTIVE The objective of this study was to inform a potential modification to the supplements distributed to pregnant and lactating women and children. METHODS Impact was assessed using 2 cluster-randomized trials (pregnant women, children) run simultaneously. Communities (n = 54) were randomly assigned to the fortified foods provided by the program (Nutrivida women, Nutrisano children) or alternatives: tablets (women), syrup (children), or micronutrient powders for women (MNP-W) and children (MNP-C). Each supplement for women/children contained the same micronutrients based on the formulations of Nutrivida and Nutrisano, respectively. Pregnant women (aged >18 y) were recruited before 25 weeks of gestation and followed to 3 mo postpartum. Children aged 6-12 mo were recruited and followed to age 24 mo. Primary outcomes were anemia for women and length growth for children. Statistical analyses appropriate for cluster-randomized designs were used, and structural equation modeling to estimate dose-response effects. Supplement costs per beneficiary (daily dose for 18 mo) were estimated for production and distribution. RESULTS There was no significant difference in change of anemia prevalence between supplement groups in women, or in length growth between groups in children. One daily dose of any supplement was associated with 0.8 cm greater length growth. From baseline to age 24 mo, the prevalence of anemia in the Nutrisano, syrup, and MNP-C groups decreased by 36.7, 40.8, and 37.9 percentage points, respectively (within-group, P < 0.05; between groups, P > 0.05). Costs per beneficiary ranged from $12.1 (MNP-C) to $94.8 (Nutrivida). CONCLUSIONS The CCT program could distribute alternative supplements at lower cost per beneficiary without compromising potential for impact. Acceptance among beneficiaries should also be considered in choice of alternatives. This trial was registered at www.clinicaltrials.gov as NCT00531674.",2019,"There was no significant difference in change of anemia prevalence between supplement groups in women, or in length growth between groups in children.","['Children aged 6-12 mo were recruited and followed to age 24 mo', 'pregnant and lactating women and children', 'Pregnant women (aged >18 y', '2 cluster-randomized trials (pregnant women, children) run simultaneously', 'Communities (n\xa0=\xa054']","['fortified foods provided by the program (Nutrivida women, Nutrisano children) or alternatives: tablets (women), syrup (children), or micronutrient powders for women (MNP-W) and children (MNP-C']","['prevalence of anemia', 'anemia for women and length growth for children', 'anemia prevalence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016498', 'cui_str': 'Enriched Food'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.186284,"There was no significant difference in change of anemia prevalence between supplement groups in women, or in length growth between groups in children.","[{'ForeName': 'Lynnette M', 'Initials': 'LM', 'LastName': 'Neufeld', 'Affiliation': 'Global Alliance for Improved Nutrition (GAIN), Geneva, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'García-Guerra', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Amado D', 'Initials': 'AD', 'LastName': 'Quezada', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Théodore', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Anabelle', 'Initials': 'A', 'LastName': 'Bonvecchio Arenas', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Clara Domínguez', 'Initials': 'CD', 'LastName': 'Islas', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Garcia-Feregrino', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Colchero', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Habicht', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz176'] 3352,32182274,Prevalence and risk factors for latent tuberculosis infection among household contacts of index cases in two South African provinces: Analysis of baseline data from a cluster-randomised trial.,"INTRODUCTION Household contacts of patients with active pulmonary tuberculosis (TB) often have latent TB infection, and are at risk of progression to disease. We set out to investigate whether index TB case HIV status was linked to a higher probability of latent TB infection among household contacts. MATERIALS AND METHODS Data were collected prospectively from participants in the intervention arm of a household cluster-randomised trial in two South Africa provinces (Mangaung, Free State, and Capricorn, Limpopo). In intervention group households, TB contacts underwent HIV testing and tuberculin skin testing (TST). TST induration was estimated at two cut-offs (≥5mm, ≥10mm). Multilevel Bayesian regression models estimated posterior distributions of the percentage of household contacts with TST induration ≥5mm and ≥10mm by age group, and compared the odds of latent TB infection by key risk factors including HIV status index case age and study province. RESULTS A total of 2,985 household contacts of 924 index cases were assessed, with most 2,725 (91.3%) undergoing TST. HIV prevalence in household contacts was 14% and 10% in Mangaung and Capricorn respectively. Overall, 16.8% (458/2,725) had TST induration of ≥5mm and 13.1% (359/2,725) ≥10mm. In Mangaung, children aged 0-4 years had a high TST positivity prevalence compared to their peers in Capricorn (22.0% vs. 7.6%, and 20.5% vs. 2.3%, using TST thresholds of ≥5mm and ≥10mm respectively). Compared to contacts from Capricorn, household contacts living in Mangaung were more likely to have TST induration ≥5mm (odds ratio [OR]: 3.08, 95% credibility interval [CI]: 2.13-4.58) and ≥10mm (OR: 4.52, 95% CI: 3.03-6.97). There was a 90% and 92% posterior probability that the odds of TST induration ≥5mm (OR: 0.79, 95% CI: 0.56-1.14) and ≥10mm (OR: 0.77, 95% CI: 0.53-1.10) respectively were lower in household contacts of HIV-positive compared to HIV-negative index cases. CONCLUSIONS High TST induration positivity, especially among young children and people living in Mangaung indicates considerable TB transmission despite high antiretroviral therapy coverage. Household contact of HIV-positive index TB cases were less likely to have evidence of latent TB infection than contacts of HIV-negative index cases.",2020,Household contact of HIV-positive index TB cases were less likely to have evidence of latent TB infection than contacts of HIV-negative index cases.,"['patients with active pulmonary tuberculosis (TB', 'Data were collected prospectively from participants in the intervention arm of a household cluster-randomised trial in two South Africa provinces (Mangaung, Free State, and Capricorn, Limpopo', 'household contacts of index cases in two South African provinces']",['HIV testing and tuberculin skin testing (TST'],"['TST induration', 'TST positivity prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041289', 'cui_str': 'Tuberculin'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0332534', 'cui_str': 'Induration (morphologic abnormality)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",2.0,0.214704,Household contact of HIV-positive index TB cases were less likely to have evidence of latent TB infection than contacts of HIV-negative index cases.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacPherson', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, England, United Kingdom.'}, {'ForeName': 'Limakatso', 'Initials': 'L', 'LastName': 'Lebina', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kegaugetswe', 'Initials': 'K', 'LastName': 'Motsomi', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Zama', 'Initials': 'Z', 'LastName': 'Bosch', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Minja', 'Initials': 'M', 'LastName': 'Milovanovic', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ratsela', 'Affiliation': 'Department of Internal Medicine, University of Limpopo, and Limpopo Department of Health, Polokwane, South Africa.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Lala', 'Affiliation': 'Department of Paediatrics and Child Health, Chris Hani Baragwanath Academic Hospital and University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'Department of Internal Medicine, Klerksdorp Tshepong Hospital Complex, North West Department of Health and University of the Witwatersrand, Polokwane, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Golub', 'Affiliation': 'Johns Hopkins University Center for TB Research, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, England, United Kingdom.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Martinson', 'Affiliation': 'Department of Paediatrics and Child Health, Chris Hani Baragwanath Academic Hospital and University of the Witwatersrand, Johannesburg, South Africa.'}]",PloS one,['10.1371/journal.pone.0230376'] 3353,31515704,The Design and Rationale of the Trail1 Trial: A Randomized Double-Blind Phase 2 Clinical Trial of Pirfenidone in Rheumatoid Arthritis-Associated Interstitial Lung Disease.,"INTRODUCTION Rheumatoid arthritis (RA) is the most common of the connective tissue diseases (CTD), affecting up to 0.75% of the United States (U.S.) population with an increasing prevalence. Interstitial lung disease is prevalent and morbid condition in RA (RA-ILD), affecting up to 60% of patients with RA, leading to premature death in 10% and accruing an average of US$170,000 in healthcare costs per patient over a 5-year period. Although there have been significant advances in the management of this joint disease, there are no ongoing randomized clinical trials looking at pharmacologic treatments for RA-ILD, and there currently are no U.S. Food and Drug Administration-approved drugs for RA-ILD. METHODS/DESIGN We describe the Treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) trial, a multicenter randomized, double-blind, placebo-controlled, phase 2 study of the safety, tolerability and efficacy of pirfenidone in patients with RA-ILD. The study will enroll approximately 270 subjects across a network of sites who have RA and ILD as defined by a fibrotic abnormality involving greater than 10% of the lung parenchyma. The primary endpoint of the study is the incidence of the composite endpoint of decline in percent predicted forced vital capacity of 10 or greater or death during the 52-week study period. A number of secondary and exploratory endpoints have been chosen to evaluate the safety and efficacy in different domains. DISCUSSION The TRAIL1 trial is designed to evaluate the safety and efficacy of pirfenidone in RA-ILD, a disease with significant impact on patients' quality of life and outcome. In addition to investigating the safety and efficacy of pirfenidone, this trial looks at a number of exploratory endpoints in an effort to better understand the impact of therapy on areas such as changes in quantitative high-resolution computed tomography scores and a patient's quality of life. Biospecimens will be collected in order to investigate biomarkers that could potentially predict the subtype of disease, its behavior over time, and its response to therapy. Finally, by creating a network of institutions and clinician investigators with an interest in RA-ILD, this trial will pave the way for future studies of investigational agents in an effort to reduce or eliminate the burden of disease for those suffering from RA-ILD. TRIAL FUNDING Genentech, a member of the Roche Group. TRIAL REGISTRATION Clinicaltrials.gov, identifier NCT02808871.",2019,"We describe the Treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) trial, a multicenter randomized, double-blind, placebo-controlled, phase 2 study of the safety, tolerability and efficacy of pirfenidone in patients with RA-ILD.","['patients with RA-ILD', '270 subjects across a network of sites who have RA and ILD as defined by a fibrotic abnormality involving greater than 10% of the lung parenchyma', 'Rheumatoid Arthritis-Associated Interstitial Lung Disease']","['placebo', 'Pirfenidone', 'pirfenidone']","['forced vital capacity of 10 or greater or death', 'safety, tolerability and efficacy', 'safety and efficacy', 'premature death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1855073', 'cui_str': 'Death, Premature'}]",270.0,0.254647,"We describe the Treatment for Rheumatoid Arthritis and Interstitial Lung Disease 1 (TRAIL1) trial, a multicenter randomized, double-blind, placebo-controlled, phase 2 study of the safety, tolerability and efficacy of pirfenidone in patients with RA-ILD.","[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Solomon', 'Affiliation': 'National Jewish Health, Denver, CO, USA. SolomonJ@NJHealth.org.'}, {'ForeName': 'Sonye K', 'Initials': 'SK', 'LastName': 'Danoff', 'Affiliation': 'Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Goldberg', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Woodhead', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolb', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Chambers', 'Affiliation': 'University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'DiFranco', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Haynes-Harp', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Hurwitz', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Peters', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Ivan O', 'Initials': 'IO', 'LastName': 'Rosas', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-019-01086-2'] 3354,32195749,Who Accepts and Who Uses Community-Based Secondary Distribution HIV Self-Testing (HIVST) Kits? Findings From the Intervention Arm of a Cluster-Randomized Trial of HIVST Distribution Nested in Four HPTN 071 (PopART) Communities in Zambia.,"BACKGROUND HPTN 071 (PopART) was a community-randomized trial of a universal testing-and-treatment intervention on HIV incidence at population level in Zambia and South Africa. In Zambia, a trial of community-based distribution of HIV self-testing (HIVST) kits, including secondary distribution, as an option for HIV-testing was nested within 4 PopART intervention communities. We used data from the intervention arm of the nested trial to measure levels of and factors associated with acceptance and use of secondary distribution HIVST kits. METHODS Community HIV care providers offered the PopART combination HIV-prevention intervention door-to-door, systematically visiting all households and enumerating all household members. From 1 February to 30 April 2017, individuals aged 16 years and older consenting to PopART were offered the option to HIV self-test, if eligible for HIV-testing services. Individuals aged 18 years and older who reported a partner absent during household visits were offered an HIVST kit for secondary distribution to this partner. We used two data sources to measure acceptance and use of secondary distribution HIVST kits. RESULTS Among 9105 individuals aged 18 years and older consenting to PopART, 9.1% (n = 825) accepted an HIVST kit for secondary distribution. Approximately 55.8% reported that the kit had been used. Women were more likely to accept, and men more likely to use, secondary distribution HIVST kits. Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART. Approximately 6.8% had a reactive result. CONCLUSIONS Community-based secondary distribution of HIVST kits reached men absent during community HIV care provider household visits and is a complement to facility- and community-based HIV-testing services, which often miss men.",2020,Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART.,"['9,105 individuals ≥18-years consenting to PopART, 9.1% (n=825) accepted an HIVST kit for secondary distribution', 'individuals aged 30+ and who had not participated in a previous round of PopART', 'HIV incidence at population-level in Zambia and South Africa', 'distribution nested in four HPTN 071 (PopART) communities in Zambia', 'Individuals ≥18-years who reported a partner absent during household visits', 'Community HIV Care Providers (CHiPs) offered the PopART combination HIV-prevention intervention door-to-door, systematically visiting all households and enumerating all household members']","['universal testing-and-treatment intervention', 'HIVST', 'HIVST kit']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]",[],,0.0372186,Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART.,"[{'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Albertus J', 'Initials': 'AJ', 'LastName': 'Schaap', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Chama', 'Initials': 'C', 'LastName': 'Mulubwa', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Mwelwa M', 'Initials': 'MM', 'LastName': 'Phiri', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Chiti', 'Initials': 'C', 'LastName': 'Bwalya', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Musonda', 'Initials': 'M', 'LastName': 'Simwinga', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College, London, United Kingdom and Imperial College NIHR BRC.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Mwinga', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002344'] 3355,32160661,Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome.,"BACKGROUND In patients with acute respiratory distress syndrome (ARDS), the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network recommends a target partial pressure of arterial oxygen (Pao 2 ) between 55 and 80 mm Hg. Prospective validation of this range in patients with ARDS is lacking. We hypothesized that targeting the lower limit of this range would improve outcomes in patients with ARDS. METHODS In this multicenter, randomized trial, we assigned patients with ARDS to receive either conservative oxygen therapy (target Pao 2 , 55 to 70 mm Hg; oxygen saturation as measured by pulse oximetry [Spo 2 ], 88 to 92%) or liberal oxygen therapy (target Pao 2 , 90 to 105 mm Hg; Spo 2 , ≥96%) for 7 days. The same mechanical-ventilation strategies were used in both groups. The primary outcome was death from any cause at 28 days. RESULTS After the enrollment of 205 patients, the trial was prematurely stopped by the data and safety monitoring board because of safety concerns and a low likelihood of a significant difference between the two groups in the primary outcome. Four patients who did not meet the eligibility criteria were excluded. At day 28, a total of 34 of 99 patients (34.3%) in the conservative-oxygen group and 27 of 102 patients (26.5%) in the liberal-oxygen group had died (difference, 7.8 percentage points; 95% confidence interval [CI], -4.8 to 20.6). At day 90, 44.4% of the patients in the conservative-oxygen group and 30.4% of the patients in the liberal-oxygen group had died (difference, 14.0 percentage points; 95% CI, 0.7 to 27.2). Five mesenteric ischemic events occurred in the conservative-oxygen group. CONCLUSIONS Among patients with ARDS, early exposure to a conservative-oxygenation strategy with a Pao 2 between 55 and 70 mm Hg did not increase survival at 28 days. (Funded by the French Ministry of Health; LOCO 2 ClinicalTrials.gov number, NCT02713451.).",2020,"At day 28, a total of 34 of 99 patients (34.3%) in the conservative-oxygen group and 27 of 102 patients (26.5%) in the liberal-oxygen group had died (difference, 7.8 percentage points; 95% confidence interval [CI], -4.8 to 20.6).","['patients with acute respiratory distress syndrome (ARDS', 'Acute Respiratory Distress Syndrome', 'patients with ARDS to receive either', 'patients with ARDS', 'Four patients who did not meet the eligibility criteria were excluded', 'patients with ARDS, early exposure to a conservative-oxygenation strategy with a Pao 2 between 55 and 70 mm']","['Liberal or Conservative Oxygen Therapy', 'conservative oxygen therapy (target Pao 2 , 55 to 70 mm Hg; oxygen saturation as measured by pulse oximetry', 'liberal oxygen therapy']","['survival', 'died', 'death from any cause at 28 days', 'Five mesenteric ischemic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0025474', 'cui_str': 'Mesentery'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",2.0,0.474788,"At day 28, a total of 34 of 99 patients (34.3%) in the conservative-oxygen group and 27 of 102 patients (26.5%) in the liberal-oxygen group had died (difference, 7.8 percentage points; 95% confidence interval [CI], -4.8 to 20.6).","[{'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Barrot', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Mauny', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Hadrien', 'Initials': 'H', 'LastName': 'Winiszewski', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Montini', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Badie', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Pili-Floury', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Belaid', 'Initials': 'B', 'LastName': 'Bouhemad', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Louis', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Collange', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Pottecher', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Puyraveau', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Vettoretti', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Constantin', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Capellier', 'Affiliation': 'From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916431'] 3356,32176166,Feasibility of a trauma quality-of-life follow-up clinic.,"BACKGROUND Little effort has been made to address long-term quality of life, chronic pain (CP), posttraumatic stress disorder (PTSD), and functional disability in trauma survivors. This quality initiative was developed to determine feasibility of a coordinated, comprehensive, patient-centered follow-up clinic for those at risk for poor long-term outcomes. METHODS A convenience sample from 649 hospitalized trauma patients at a Midwestern level 1 trauma center between February 2018 and August 2018 was screened for risk of PTSD and CP. Thirty-six patients were randomized into a standard follow-up clinic (standard of care [SOC]) (2-week postdischarge surgical clinic) or a new trauma quality of life clinic (TQOL). The TQOL was developed to provide comprehensive care to patients at high risk for PTSD (Injured Trauma Survivor Score, ≥2) and/or CP (discharge pain score, ≥4). Trauma quality of life clinic included a nurse practitioner or surgeon (physician), psychologist, social worker, and physical therapist at 1-week post discharge. All providers saw the patient independently, developed a care plan collaboratively, and communicated the plan to the patient. The SOC involved a visit only with a nurse practitioner or surgeon (medical doctor). Measures of pain, PTSD, depression, quality of life, physical functioning, and life satisfaction were completed at time of the TQOL/SOC or over the phone. RESULTS There were no differences in demographics, readmissions, or emergency department visits after discharge between groups. However, no show rates were almost twice as high in SOC (40%) compared with TQOL (22%) and those in TQOL completed 23 additional psychology visits versus one psychology visit in SOC. This clinic structure is feasible for high-risk patients, and TQOL patients demonstrated improved engagement in their care. CONCLUSIONS A comprehensive multidisciplinary TQOL addressing issues affecting convalescence for trauma patients at high risk for developing PTSD and CP can improve follow-up rates to ensure patients are recovering successfully. LEVEL OF EVIDENCE Therapeutic, Level IV.",2020,"There were no differences in demographics, readmissions, or emergency department visits after discharge between groups.","['trauma patients', '36 patients', '649 hospitalized trauma patients at a Midwestern level 1 trauma center between 2/2018 and 8/2018 was screened for risk of PTSD and CP', 'high risk patients and TQOL patients']","['standard follow-up clinic (SOC) (2-week post-discharge surgical clinic) or a new trauma quality of life clinic (TQOL', 'TQOL']","['TQOL included a nurse practitioner or surgeon(NP/MD), psychologist, social worker, and physical therapist', 'pain, PTSD, depression, QOL, physical functioning, and life satisfaction', 'demographics, readmissions, or emergency department visits']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034380'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",36.0,0.0384627,"There were no differences in demographics, readmissions, or emergency department visits after discharge between groups.","[{'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Trevino', 'Affiliation': 'From the Department of Surgery, Division of Trauma and Acute Care Surgery, Medical College of Wisconsin (C.T., T.G., D.J.M., P.C., T.d.-C.); Department of Psychology, Marquette University (S.C.T.-M.); and Froedtert Lutheran Memorial Hospital (M.S.), Milwaukee, Wisconsin.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Geier', 'Affiliation': ''}, {'ForeName': 'Sydney C', 'Initials': 'SC', 'LastName': 'Timmer-Murillo', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Shawlin', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Milia', 'Affiliation': ''}, {'ForeName': 'Panna', 'Initials': 'P', 'LastName': 'Codner', 'Affiliation': ''}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'deRoon-Cassini', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002672'] 3357,31981713,High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial.,"INTRODUCTION Phase 2 clinical trials of tuberculosis treatment have shown that once-daily regimens in which rifampin is replaced by high dose rifapentine have potent antimicrobial activity that may be sufficient to shorten overall treatment duration. Herein we describe the design of an ongoing phase 3 clinical trial testing the hypothesis that once-daily regimens containing high dose rifapentine in combination with other anti-tuberculosis drugs administered for four months can achieve cure rates not worse than the conventional six-month treatment regimen. METHODS/DESIGN S31/A5349 is a multicenter randomized controlled phase 3 non-inferiority trial that compares two four-month regimens with the standard six-month regimen for treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients. Both of the four-month regimens contain high-dose rifapentine instead of rifampin, with ethambutol replaced by moxifloxacin in one regimen. All drugs are administered seven days per week, and under direct observation at least five days per week. The primary outcome is tuberculosis disease-free survival at twelve months after study treatment assignment. A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of non-inferiority. DISCUSSION This phase 3 trial formally tests the hypothesis that augmentation of rifamycin exposures can shorten tuberculosis treatment to four months. Trial design and standardized implementation optimize the likelihood of obtaining valid results. Results of this trial may have important implications for clinical management of tuberculosis at both individual and programmatic levels. TRIAL REGISTRATION NCT02410772. Registered 8 April 2015,https://www.clinicaltrials.gov/ct2/show/NCT02410772?term=02410772&rank=1.",2020,A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of,"['pulmonary tuberculosis', '2500 participants', 'treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients']","['moxifloxacin', 'rifapentine with or without moxifloxacin']","['cure rates', 'tuberculosis disease-free survival']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}]","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",2500.0,0.389641,A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of,"[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Dorman', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA. Electronic address: dorman@musc.edu.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Nahid', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Ekaterina V', 'Initials': 'EV', 'LastName': 'Kurbatova', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Goldberg', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Bozeman', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, Denver, CO, USA.'}, {'ForeName': 'Kwok-Chiu', 'Initials': 'KC', 'LastName': 'Chang', 'Affiliation': 'Tuberculosis and Chest Service, Department of Health, Hong Kong.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cotton', 'Affiliation': 'Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Engle', 'Affiliation': 'Audie L. Murphy Veterans Affairs Medical Center / University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Pei-Jean', 'Initials': 'PJ', 'LastName': 'Feng', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Fletcher', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Phan', 'Initials': 'P', 'LastName': 'Ha', 'Affiliation': 'Vietnam National TB Program (NTP)/UCSF Research Collaboration, Hanoi, Viet Nam.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Heilig', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Lessem', 'Affiliation': 'Treatment Action Group, NY, New York, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Metchock', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Miro', 'Affiliation': 'Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nguyen Viet', 'Initials': 'NV', 'LastName': 'Nhung', 'Affiliation': 'Vietnam National TB Program (NTP)/UCSF Research Collaboration, Hanoi, Viet Nam.'}, {'ForeName': 'April C', 'Initials': 'AC', 'LastName': 'Pettit', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, USA.'}, {'ForeName': 'Patrick P J', 'Initials': 'PPJ', 'LastName': 'Phillips', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Podany', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Purfield', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA; U.S. Public Health Service Commissioned Corps, Rockville, MD, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Robergeau', 'Affiliation': 'Westat, Inc., Rockville, MD, USA.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Parirenyatwa Clinical Research Site, Harare, Zimbabwe.'}, {'ForeName': 'Nigel A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Sizemore', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vernon', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Weiner', 'Affiliation': 'Audie L. Murphy Veterans Affairs Medical Center / University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.105938'] 3358,31620306,Does the addition of a supportive chatbot promote user engagement with a smoking cessation app? An experimental study.,"Objective The objective of this study was to assess whether a version of the Smoke Free app with a supportive chatbot powered by artificial intelligence (versus a version without the chatbot) led to increased engagement and short-term quit success. Methods Daily or non-daily smokers aged ≥18 years who purchased the 'pro' version of the app and set a quit date were randomly assigned (unequal allocation) to receive the app with or without the chatbot. The outcomes were engagement (i.e. total number of logins over the study period) and self-reported abstinence at a one-month follow-up. Unadjusted and adjusted negative binomial and logistic regression models were fitted to estimate incidence rate ratios (IRRs) and odds ratios (ORs) for the associations of interest. Results A total of 57,214 smokers were included (intervention: 9.3% (5339); control: 90.7% (51,875). The app with the chatbot compared with the standard version led to a 101% increase in engagement (IRR adj  = 2.01, 95% confidence interval ( CI) = 1.92-2.11, p  < .001). The one-month follow-up rate was 10.6% (intervention: 19.9% (1,061/5,339); control: 9.7% (5,050/51,875). Smokers allocated to the intervention had greater odds of quit success (missing equals smoking: 844/5,339 vs . 3,704/51,875, OR adj  = 2.38, 95% CI = 2.19-2.58, p  < .001; follow-up only: 844/1,061 vs . 3,704/5,050, OR adj  = 1.36, 95% CI = 1.16-1.61, p  < .001). Conclusion The addition of a supportive chatbot to a popular smoking cessation app more than doubled user engagement. In view of very low follow-up rates, there is low quality evidence that the addition also increased self-reported smoking cessation.",2019,"The app with the chatbot compared with the standard version led to a 101% increase in engagement (IRR adj  = 2.01, 95% confidence interval ( CI) = 1.92-2.11, p  < .001).","[""daily smokers aged ≥18 years who purchased the 'pro' version of the app and set a quit date"", '57,214 smokers were included (intervention: 9.3% (5339); control: 90.7% (51,875']","['Methods\n\n\nDaily or non', 'Smoke Free app with a supportive chatbot powered by artificial intelligence (versus a version without the chatbot']","['incidence rate ratios (IRRs) and odds ratios (ORs', 'total number of logins over the study period) and self-reported abstinence', 'quit success (missing equals smoking']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0003916', 'cui_str': 'AI (Artificial Intelligence)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",,0.10624,"The app with the chatbot compared with the standard version led to a 101% increase in engagement (IRR adj  = 2.01, 95% confidence interval ( CI) = 1.92-2.11, p  < .001).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Perski', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Beard', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Department of Behavioural Science and Health, University College London, UK.'}]",Digital health,['10.1177/2055207619880676'] 3359,31254130,Restricting vitamin A intake increases bone formation in Zambian children with high liver stores of vitamin.,"This analysis was performed in Zambian children who had a high prevalence of hypervitaminosis A, defined as > 1.0 μmol retinol/g liver. Bone parameters included markers of bone formation (P1NP), bone resorption (CTX), parathyroid hormone, calcium, vitamin A, and vitamin D. Low dietary vitamin A intake increased P1NP. PURPOSE Vitamin A (VA) interacts with bone health, but mechanisms require clarification. In countries where multiple interventions exist to eradicate VA deficiency, some groups are consuming excessive VA. Bone metabolism and inflammatory parameters were measured in Zambian children who had high prevalence of hypervitaminosis A determined by 13 C-retinol isotope dilution. METHODS Children (n = 143), 5 to 7 years, were recruited into a placebo-controlled biofortified orange maize feeding study for 90 days. Bone turnover (P1NP and CTX) and inflammatory (C-reactive protein (CRP) and alpha-1-acid glycoprotein) biomarkers were measured in fasting blood samples before and/or after intervention with the following: (1) VA at the recommended dietary allowance (400 μg retinol activity equivalents/day (as retinyl palmitate)), (2) maize enhanced with the provitamin A carotenoid β-carotene (2.86 mg/day), or (3) a placebo. Parathyroid hormone, calcium, and 25(OH)-vitamin D were measured at end line. RESULTS Bone formation, as measured by P1NP, increased (P < 0.0001) in the placebo group who consumed low preformed VA during the intervention. Bone resorption, measured by CTX, was not affected. P1NP and CTX were negatively associated with inflammation, most strongly with CRP. Serum calcium did not differ among groups and was low (7.29 ± 0.87 μg/dL). Serum 25(OH) D did not differ among groups (54.5 ± 15 nmol/L), with 91% < 75 nmol/L and 38% < 50 nmol/L. CONCLUSIONS Reduction of dietary preformed VA in Zambian children for 4 months improved bone formation. Chronic consumption of preformed VA caused hypervitaminosis A and may impair bone formation. In children, this could be associated with failure to accrue optimal peak bone mass. TRIAL REGISTRATION The NIH Clinical Trial registry number is NCT01814891; https://clinicaltrials.gov/ct2/show/NCT01814891 .",2019,"RESULTS Bone formation, as measured by P1NP, increased (P < 0.0001) in the placebo group who consumed low preformed VA during the intervention.","['Zambian children who had a high prevalence of hypervitaminosis A, defined as >\u20091.0\xa0μmol retinol/g liver', 'Zambian children with high liver stores of vitamin', 'Zambian children who had high prevalence of hypervitaminosis A determined by 13 C-retinol isotope dilution', 'Children (n\u2009=\u2009143), 5 to 7\xa0years']","['Restricting vitamin A intake', 'placebo-controlled biofortified orange maize feeding', 'provitamin A carotenoid β-carotene', 'placebo']","['bone formation (P1NP), bone resorption (CTX), parathyroid hormone, calcium, vitamin A', 'Bone turnover (P1NP and CTX) and inflammatory (C-reactive protein (CRP) and alpha-1-acid glycoprotein) biomarkers', 'Serum calcium', 'bone formation', 'Bone metabolism and inflammatory parameters', 'Bone resorption', 'Parathyroid hormone, calcium, and 25(OH)-vitamin D', 'Serum 25(OH']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0020579', 'cui_str': 'Hypervitaminosis A'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0729631', 'cui_str': 'C-13 isotope'}, {'cui': 'C0022262', 'cui_str': 'Isotopes'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0564436', 'cui_str': 'Vitamin A intake (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0053396', 'cui_str': 'betacarotene'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0029297', 'cui_str': 'alpha 1-Acid Glycoprotein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.285303,"RESULTS Bone formation, as measured by P1NP, increased (P < 0.0001) in the placebo group who consumed low preformed VA during the intervention.","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Tanumihardjo', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, 1415 Linden Dr., Madison, WI, 53706, USA. sherry@nutrisci.wisc.edu.'}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Gannon', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, 1415 Linden Dr., Madison, WI, 53706, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kaliwile', 'Affiliation': 'National Food and Nutrition Commission of Zambia, P.O. Box 32669, Lusaka, Zambia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chileshe', 'Affiliation': 'Tropical Diseases Research Center, Ndola, Zambia.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Binkley', 'Affiliation': 'Osteoporosis Clinical Research Program, University of Wisconsin-Madison, Madison, WI, USA.'}]",Archives of osteoporosis,['10.1007/s11657-019-0617-y'] 3360,31805256,"A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Hepatocyte Growth Factor in the Treatment of Critical Limb Ischemia.","NL003 is a plasmid engineered to simultaneously express two isoforms of hepatocyte growth factor. This phase II study was performed to assess the clinical safety and efficacy of intramuscular injection of NL003 in critical limb ischemia (CLI) patients for 6 months. Two hundred patients (Rutherford scale 4-5) were randomly assigned: placebo (n = 50), low-dose NL003 (n = 50), middle-dose NL003 (n = 50), or high-dose NL003 (n = 50). The drug was administered in the affected limb of 197 patients on days 0, 14, and 28. No significant differences in the incidence of adverse events (AEs) or serious AEs were found among the groups. At 6 months, pain severity was significantly reduced in all NL003 groups, but not in the placebo group (p < 0.05). The proportion of patients with complete ulcer healing in the high-dose group was significantly higher than that of the placebo group (p = 0.0095). There were no statistically significant differences in transcutaneous oxygen pressure (TcPO 2 ), ankle-brachial index (ABI), or toe-brachial index (TBI) value among the four groups throughout the study period. These results provide the first effective evidence of significant improvements in total healing of ulcers in treated legs, complete pain relief without analgesics, and safety for NL003 in patients with Rutherford stage 4-5.",2019,"There were no statistically significant differences in transcutaneous oxygen pressure (TcPO 2 ), ankle-brachial index (ABI), or toe-brachial index (TBI) value among the four groups throughout the study period.","['197 patients on days 0, 14, and 28', 'Critical Limb Ischemia', 'critical limb ischemia (CLI) patients for 6\xa0months', 'Two hundred patients (Rutherford scale 4-5']","['intramuscular injection of NL003', 'Placebo', 'placebo', 'low-dose NL003 (n\xa0= 50), middle-dose NL003 (n\xa0= 50), or high-dose NL003']","['total healing of ulcers', 'pain severity', 'transcutaneous oxygen pressure (TcPO 2 ), ankle-brachial index (ABI), or toe-brachial index (TBI) value', 'pain relief without analgesics, and safety for NL003', 'proportion of patients with complete ulcer healing', 'incidence of adverse events (AEs) or serious AEs', 'clinical safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0222045'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C2116889', 'cui_str': 'Toe Brachial Index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",200.0,0.0758731,"There were no statistically significant differences in transcutaneous oxygen pressure (TcPO 2 ), ankle-brachial index (ABI), or toe-brachial index (TBI) value among the four groups throughout the study period.","[{'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Vascular Surgery Department, Xuan Wu Hospital, Capital Medical University, Beijing, China. Electronic address: 15901598209@163.com.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Vascular Surgery Department, Xuan Wu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Vascular Surgery Department, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Changjian', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Vascular Surgery Department, Nanjing Drum Tower Hospital, Nanjing, China.'}, {'ForeName': 'Bi', 'Initials': 'B', 'LastName': 'Jin', 'Affiliation': 'Vascular Surgery Department, Wuhan Union Hospital, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Vascular Surgery Department, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Vascular Surgery Department, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Tongbin', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Diabetic Foot Treatment Center, Second Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Shu', 'Affiliation': 'Vascular Surgery Department, Second Xiang Ya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Fuxian', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Vascular Surgery Department, Shi Ji Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chengquan', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'R&D Center of Beijing Northland Biotech. Co., Ltd., China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'R&D Center of Beijing Northland Biotech. Co., Ltd., China.'}]",Molecular therapy : the journal of the American Society of Gene Therapy,['10.1016/j.ymthe.2019.10.017'] 3361,31264800,Mindfulness-based cognitive therapy for children and adolescents with anxiety disorders at-risk for bipolar disorder: A psychoeducation waitlist controlled pilot trial.,"AIM Previous studies suggest that Mindfulness-Based Cognitive Therapy for Children (MBCT-C) is feasible and may improve anxiety and emotion regulation in youth with anxiety disorders at-risk for bipolar disorder. However, controlled studies are warranted to replicate and extend these findings. METHODS In the current study, 24 youth with anxiety disorders who have at least one parent with bipolar disorder participated in a MBCT-C treatment period (n = 24; M age = 13.6, 75% girls, 79% White) with a subset also participating in a prior psychoeducation waitlist control period (n = 19 M age = 13.8, 68% girls, 84% White). Participants in both the waitlist and MBCT-C periods completed independently-rated symptom scales at each time point. Participants in the waitlist period received educational materials 12 weeks prior to the beginning of MBCT-C. RESULTS There were significantly greater improvements in overall clinical severity in the MBCT-C period compared to the waitlist period, but not in clinician- and child-rated anxiety, emotion regulation or mindfulness. However, increases in mindfulness were associated with improvements in anxiety and emotion regulation in the MBCT-C period, but not the waitlist period. CONCLUSIONS Findings suggest that MBCT-C may be effective for improving overall clinical severity in youth with anxiety disorders who are at-risk for bipolar disorder. However, waitlist controlled designs may inflate effect sizes so interpret with caution. Larger studies utilizing prospective randomized controlled designs are warranted.",2020,"However, increases in mindfulness were associated with improvements in anxiety and emotion regulation in the MBCT-C period, but not the waitlist period. ","['youth with anxiety disorders at-risk for bipolar disorder', 'youth with anxiety disorders who are at-risk for bipolar disorder', '24 youth with anxiety disorders who have at least one parent with bipolar disorder participated in a MBCT-C treatment period (n = 24; M age = 13.6, 75% girls, 79% White) with a subset also participating in a prior psychoeducation waitlist control period (n = 19 M age = 13.8, 68% girls, 84% White', 'Children (MBCT-C', 'children and adolescents with anxiety disorders at-risk for bipolar disorder']","['Mindfulness-based cognitive therapy', 'MBCT-C', 'Mindfulness-Based Cognitive Therapy']","['clinician- and child-rated anxiety, emotion regulation or mindfulness', 'overall clinical severity', 'anxiety and emotion regulation']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",24.0,0.0283536,"However, increases in mindfulness were associated with improvements in anxiety and emotion regulation in the MBCT-C period, but not the waitlist period. ","[{'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Kraemer', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Sears', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Wasson', 'Affiliation': 'Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'McCune', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Welge', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Durling', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Delbello', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Early intervention in psychiatry,['10.1111/eip.12848'] 3362,32034015,Multicentre randomised controlled trial of balloon pulmonary angioplasty and riociguat in patients with chronic thromboembolic pulmonary hypertension: protocol for the MR BPA study.,"INTRODUCTION Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, medical treatment involving pulmonary vasodilators (such as soluble guanylate-cyclase stimulators) is recommended, primarily for ameliorating symptoms. More recently, balloon pulmonary angioplasty (BPA) has been developed as alternative treatment for inoperable CTEPH. This study aimed to compare the efficacy and safety of BPA and riociguat (a soluble guanylate-cyclase stimulator) as treatments for inoperable CTEPH. METHODS AND ANALYSIS This study is a multicentre randomised controlled trial. Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment. The primary endpoint will be the change in mean pulmonary arterial pressure from baseline to 12 months after initiation of treatment. For primary analysis, we will estimate the least square means difference and 95% CI for the change of pulmonary arterial pressure between the groups at 12 months using the analysis of covariance adjusted for allocation factors. ETHICS AND DISSEMINATION This study and its protocols were approved by the institutional review board of Keio University School of Medicine and each participating institution. Written informed consent was obtained from all participants. Results will be disseminated at medical conferences and in journal publications. TRIAL REGISTRATION NUMBER University Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.",2020,"Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment.","['patients with chronic thromboembolic pulmonary hypertension', 'Subjects with inoperable CTEPH', 'Keio University School of Medicine and each participating institution', 'inoperable chronic thromboembolic pulmonary hypertension (CTEPH']","['balloon pulmonary angioplasty and riociguat', 'BPA and riociguat (a soluble guanylate-cyclase stimulator', 'BPA or riociguat', 'balloon pulmonary angioplasty (BPA']","['mean pulmonary arterial pressure', 'pulmonary arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363973', 'cui_str': 'Thromboembolic pulmonary hypertension (disorder)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C1097411', 'cui_str': 'Soluble Guanylate Cyclase'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}]","[{'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}]",,0.200436,"Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawakami', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan kawakami.1650@gmail.com.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Matsubara', 'Affiliation': 'Department of Cardiology and Department of Clinical Science, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kohtaro', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiovascular Medicine, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Kataoka', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University, Tokyo, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-028831'] 3363,32034019,"Antiviral therapy: Valacyclovir Treatment of Alzheimer's Disease (VALAD) Trial: protocol for a randomised, double-blind,placebo-controlled, treatment trial.","INTRODUCTION After infection, herpes simplex virus-1 (HSV1) becomes latent in the trigeminal ganglion and can enter the brain via retrograde axonal transport. Recurrent reactivation of HSV1 may lead to neurodegeneration and Alzheimer's disease (AD) pathology. HSV1 (oral herpes) and HSV2 (genital herpes) can trigger amyloid beta-protein (Aβ) aggregation and HSV1 DNA is common in amyloid plaques. Anti-HSV drugs reduce Aβ and phosphorylated tau accumulation in cell-culture models. Cognitive impairment is greater in patients with HSV seropositive, and antiviral drugs show robust efficacy against peripheral HSV infection. Recent studies of electronic health records databases demonstrate that HSV infections increase dementia risk, and that antiviral medication treatment reduces this risk. The generic antiviral drug valacyclovir was superior to placebo in improving memory in a schizophrenia pilot trial but has not been tested in AD. METHODS AND ANALYSIS In patients with mild AD who test positive for HSV1 or HSV2 serum antibodies, valacyclovir, repurposed as an anti-AD drug, will be compared with placebo (lactose pills) in 130 patients (65 valacyclovir and 65 placebo) in a randomised, double-blind, 78-week phase II proof-of-concept trial. Patients on valacyclovir, dose-titrated from 2 g to a targeted oral dose of 4 g daily, compared with placebo, are hypothesised to show smaller cognitive and functional decline, and, using 18 F-Florbetapir positron emission tomography (PET) and 18 F-MK-6240 PET imaging, to show less amyloid and tau accumulation, respectively. In the lumbar puncture subsample, cerebrospinal fluid acyclovir will be assayed to assess central nervous system valacyclovir penetration. ETHICS AND DISSEMINATION The trial is being overseen by the New York State Psychiatric Institute Institutional Review Board (protocol 7537), the National Institute on Ageing, and the Data Safety Monitoring Board. Written informed consent is obtained for all subjects. Results will be disseminated via publication, clinicaltrials.gov, media and conferences. TRIAL REGISTRATION NUMBER ClinicalTrials.gov identifier (NCT03282916) Pre-results.",2020,"The generic antiviral drug valacyclovir was superior to placebo in improving memory in a schizophrenia pilot trial but has not been tested in AD. ","['patients with mild AD who test positive for HSV1 or HSV2 serum antibodies', '130 patients (65', ""Alzheimer's Disease (VALAD"", 'patients with HSV seropositive']","['valacyclovir and 65 placebo', 'Antiviral therapy: Valacyclovir', 'placebo', 'placebo (lactose pills', 'valacyclovir', 'HSV1 (oral herpes) and HSV2 (genital herpes']",['Cognitive impairment'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}]","[{'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C3216529', 'cui_str': 'Lactose Pill'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.646693,"The generic antiviral drug valacyclovir was superior to placebo in improving memory in a schizophrenia pilot trial but has not been tested in AD. ","[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA dpd3@cumc.columbia.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Andrews', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Kreisl', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Qolamreza', 'Initials': 'Q', 'LastName': 'Razlighi', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gershon', 'Affiliation': 'Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Stern', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Akiva', 'Initials': 'A', 'LastName': 'Mintz', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wisniewski', 'Affiliation': 'Center for Cognitive Neurology, Departments of Neurology, New York University Medical Center, New York, New York, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Acosta', 'Affiliation': 'Department of Pharmacology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Pollina', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Mariasofia', 'Initials': 'M', 'LastName': 'Katsikoumbas', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Bell', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Gregory H', 'Initials': 'GH', 'LastName': 'Pelton', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Deliyannides', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Prasad', 'Affiliation': 'Departments of Psychiatry and Bioengineering, University of Pittsburgh Swanson School of Engineering, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Huey', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-032112'] 3364,31002954,18 F-Fludeoxyglucose PET/CT in SCLC: Analysis of the CONVERT Randomized Controlled Trial.,"INTRODUCTION We used phase-3 CONVERT trial data to investigate the impact of fludeoxyglucose F 18 ( 18 F-FDG) positron emission tomography (PET)/computed tomography (CT) in SCLC. METHODS CONVERT randomized patients with limited-stage SCLC to twice-daily (45 Gy in 30 fractions) or once-daily (66 Gy in 33 fractions) chemoradiotherapy. Patients were divided into two groups in this unplanned analysis: those staged with conventional imaging (contrast-enhanced thorax and abdomen CT and brain imaging with or without bone scintigraphy) and those staged with 18 F-FDG PET/CT in addition. RESULTS Data on a total of 540 patients were analyzed. Compared with patients who underwent conventional imaging (n = 231), patients also staged with 18 F-FDG PET/CT (n = 309) had a smaller gross tumor volume (p = 0.003), were less likely to have an increased pretreatment serum lactate dehydrogenase level (p = 0.035), and received more chemotherapy (p = 0.026). There were no significant differences in overall (hazard ratio = 0.87, 95% confidence interval: 0.70-1.08, p = 0.192) and progression-free survival (hazard ratio = 0.87, 95% confidence interval: 0.71-1.07], p = 0.198) between patients staged with or without 18 F-FDG PET/CT. In the conventional imaging group, we found no survival difference between patients staged with or without bone scintigraphy. Although there were no differences in delivered radiotherapy dose, 18 F-FDG PET/CT-staged patients received lower normal tissue (lung, heart, and esophagus) radiation doses. Apart from a higher incidence of late esophagitis in patients staged with conventional imaging (for grade ≥1, 19% versus 11%; [p = 0.012]), the incidence of acute and late radiotherapy-related toxicities was not different between the two groups. CONCLUSION In CONVERT, survival outcomes were not significantly different in patients staged with or without 18 F-FDG PET/CT. However, this analysis cannot support the use or omission of 18 F-FDG PET/CT owing to study limitations.",2019,"In CONVERT, survival outcomes were not significantly different in patients staged with or without 18 F-FDG PET/CT.","['CONVERT randomized patients with limited-stage', 'Data on a total of 540 patients were analyzed']","['SCLC to twice-daily (45 Gy in 30 fractions) or once-daily (66 Gy in 33 fractions) chemoradiotherapy', 'fludeoxyglucose F 18 ( 18 F-FDG) positron emission tomography (PET)/computed tomography (CT', 'conventional imaging (contrast-enhanced thorax and abdomen CT and brain imaging with or without bone scintigraphy) and those staged with 18 F-FDG PET/CT in addition', 'SCLC']","['pretreatment serum lactate dehydrogenase level', 'incidence of acute and late radiotherapy-related toxicities', 'late esophagitis', 'survival outcomes', 'progression-free survival', 'normal tissue (lung, heart, and esophagus) radiation doses', 'survival difference', 'smaller gross tumor volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0046056', 'cui_str': 'fludeoxyglucose (18F)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C3889015', 'cui_str': 'Bone scintigraphy'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332441', 'cui_str': 'Normal tissue (finding)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume (observable entity)'}]",540.0,0.277353,"In CONVERT, survival outcomes were not significantly different in patients staged with or without 18 F-FDG PET/CT.","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Manoharan', 'Affiliation': 'Department of Radiology, The Christie National Health Service Foundation Trust, Manchester, United Kingdom; Department of Nuclear Medicine, The Christie National Health Service Foundation Trust, Manchester, United Kingdom. Electronic address: prakash.manoharan@christie.nhs.uk.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Salem', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom; Department of Clinical Oncology, The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Hitesh', 'Initials': 'H', 'LastName': 'Mistry', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom; Division of Pharmacy, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gornall', 'Affiliation': 'Department of Nuclear Medicine, The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Harden', 'Affiliation': ""Department of Clinical Oncology, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Julyan', 'Affiliation': 'Department of Nuclear Medicine, The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Locke', 'Affiliation': 'Department of Clinical Oncology, The Royal Marsden National Health Service Foundation Trust, Surrey, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'McAleese', 'Affiliation': 'Department of Clinical Oncology, Northern Ireland Cancer Centre, Belfast City Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'McMenemin', 'Affiliation': 'Department of Clinical Oncology, Northern Centre for Cancer Care, Freeman Hospital, Newcastle-upon-Tyne, United Kingdom.'}, {'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Mohammed', 'Affiliation': 'Department of Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Snee', 'Affiliation': ""Department of Clinical Oncology, Leeds Cancer Centre, St James's Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Woods', 'Affiliation': 'Department of Nuclear Medicine, Manchester University National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Westwood', 'Affiliation': 'Department of Radiology, The Christie National Health Service Foundation Trust, Manchester, United Kingdom; Department of Nuclear Medicine, The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom; Department of Clinical Oncology, The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.03.023'] 3365,31025208,Are the ergogenic effects of photobiomodulation therapy age-dependent? A randomized double-blinded placebo-controlled trial.,,2020,,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.7801,,"[{'ForeName': 'Carolina Gassen', 'Initials': 'CG', 'LastName': 'Fritsch', 'Affiliation': 'Universidade de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. carolinafritsch@gmail.com.'}, {'ForeName': 'Laura Ayang', 'Initials': 'LA', 'LastName': 'Folgiarini', 'Affiliation': 'Universidade de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Natália Sgarioni', 'Initials': 'NS', 'LastName': 'Gomes', 'Affiliation': 'Universidade de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marco Aurélio', 'Initials': 'MA', 'LastName': 'Vaz', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Bruno Manfredini', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Universidade de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02790-9'] 3366,32068914,"Effects of the dual sodium-glucose linked transporter inhibitor, licogliflozin vs placebo or empagliflozin in patients with type 2 diabetes and heart failure.","AIMS Explore the efficacy, safety and tolerability of the dual sodium-glucose cotransporter (SGLT) 1 and 2 inhibitor, licogliflozin in patients with type-2 diabetes mellitus (T2DM) and heart failure. METHODS This multicentre, parallel-group phase IIA study randomized 125 patients with T2DM and heart failure (New York Heart Association II-IV; plasma N-terminal pro b-type natriuretic peptide [NT-proBNP] >300 pg/mL) to licogliflozin (2.5 mg, 10 mg, 50 mg) taken at bedtime, empagliflozin (25 mg) or placebo (44 patients completed the study). The primary endpoint was change from baseline in NT-proBNP after 12 weeks. Secondary endpoints included change from baseline in glycated haemoglobin, fasting plasma glucose, weight, blood pressure, fasting lipid profile, high-sensitivity c-reactive protein, and safety and tolerability. RESULTS Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs placebo (Geometric mean ratio 0.56 [95% confidence interval: 0.33, 0.95], P = .033). A trend was observed with 50 mg licogliflozin (0.64 [95% confidence interval: 0.40, 1.03], P = .064), with no difference between licogliflozin and empagliflozin. The largest numerical decreases in glycated haemoglobin were with licogliflozin 50 mg (-0.58 ± 0.34%) and empagliflozin (-0.44 ± 1.18%) vs placebo (-0.04 ± 0.91%). The reduction in body weight was similar with licogliflozin 50 mg (-2.15 ± 2.40 kg) and empagliflozin (-2.25 ± 1.89 kg). A numerical reduction in systolic blood pressure was seen with licogliflozin 50 mg (-9.54 ± 16.88 mmHg) and empagliflozin (-6.98 ± 15.03 mmHg) vs placebo (-2.85 ± 11.97 mmHg). Adverse events (AEs) were mild, including hypotension (6.5%), hypoglycaemia (8.1%) and inadequate diabetes control (1.6%). The incidence of diarrhoea (4.9%) was lower than previously reported. CONCLUSION The reduction in NT-proBNP with licogliflozin suggests a potential benefit of SGLT1 and 2 inhibition in patients with T2DM and heart failure.",2020,"RESULTS Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs. placebo (Geometric mean ratio 0.56 [95% CI: 0.33, 0.95], p=0.033).","['patients with type 2 diabetes and heart failure', 'patients with type-2 diabetes mellitus (T2DM) and heart failure', 'patients with T2DM and heart failure', '44 patients completed the study', '125 patients with T2DM and heart failure (NYHA II-IV; plasma NT-proBNP >300 pg/mL) to']","['placebo', 'Licogliflozin', 'empagliflozin', 'licogliflozin and empagliflozin', 'licogliflozin', 'dual sodium glucose co-transporter (SGLT) 1 and 2 inhibitor, licogliflozin', 'dual sodium-glucose linked transporter inhibitor, licogliflozin versus placebo or empagliflozin']","['inadequate diabetes control', 'NT-proBNP', 'body weight', 'change from baseline in NT-proBNP', 'systolic BP', 'efficacy, safety and tolerability', 'change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose, weight, blood pressure (BP), fasting lipid profile, high-sensitivity c-reactive protein, and safety and tolerability', 'Adverse events (AEs) were mild, including hypotension', 'hypoglycemia', 'incidence of diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0430044', 'cui_str': 'Fasting lipid profile (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",125.0,0.391465,"RESULTS Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs. placebo (Geometric mean ratio 0.56 [95% CI: 0.33, 0.95], p=0.033).","[{'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario Valencia, València, Spain.'}, {'ForeName': 'Plamen', 'Initials': 'P', 'LastName': 'Kozlovski', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Proot', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14248'] 3367,31160249,"Cediranib in patients with alveolar soft-part sarcoma (CASPS): a double-blind, placebo-controlled, randomised, phase 2 trial.","BACKGROUND Alveolar soft-part sarcoma (ASPS) is a rare soft-tissue sarcoma that is unresponsive to chemotherapy. Cediranib, a tyrosine-kinase inhibitor, has shown substantial activity in ASPS in non-randomised studies. The Cediranib in Alveolar Soft Part Sarcoma (CASPS) study was designed to discriminate the effect of cediranib from the intrinsically indolent nature of ASPS. METHODS In this double-blind, placebo-controlled, randomised, phase 2 trial, we recruited participants from 12 hospitals in the UK (n=7), Spain (n=3), and Australia (n=2). Patients were eligible if they were aged 16 years or older; metastatic ASPS that had progressed in the previous 6 months; had an ECOG performance status of 0-1; life expectancy of more than 12 weeks; and adequate bone marrow, hepatic, and renal function. Participants had to have no anti-cancer treatment within 4 weeks before trial entry, with exception of palliative radiotherapy. Participants were randomly assigned (2:1), with allocation by use of computer-generated random permuted blocks of six, to either cediranib (30 mg orally, once daily) or matching placebo tablets for 24 weeks. Treatment was supplied in number-coded bottles, masking participants and clinicians to assignment. Participants were unblinded at week 24 or sooner if they had progression defined by Response Evaluation Criteria in Solid Tumors (version 1.1); those on placebo crossed over to cediranib and all participants continued on treatment until progression or death. The primary endpoint was percentage change in sum of target marker lesion diameters between baseline and week 24 or progression if sooner, assessed in the evaluable population (all randomly assigned participants who had a scan at week 24 [or sooner if they progressed] with target marker lesions measured). Safety was assessed in all participants who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT01337401; the European Clinical Trials database, number EudraCT2010-021163-33; and the ISRCTN registry, number ISRCTN63733470 recruitment is complete and follow-up is ongoing. FINDINGS Between July 15, 2011, and July 29, 2016, of 48 participants recruited, all were randomly assigned to cediranib (n=32) or placebo (n=16). 23 (48%) were female and the median age was 31 years (IQR 27-45). Median follow-up was 34·3 months (IQR 23·7-55·6) at the time of data cutoff for these analyses (April 11, 2018). Four participants in the cediranib group were not evaluable for the primary endpoint (one did not start treatment, and three did not have their scan at 24 weeks). Median percentage change in sum of target marker lesion diameters for the evaluable population was -8·3% (IQR -26·5 to 5·9) with cediranib versus 13·4% (IQR 1·1 to 21·3) with placebo (one-sided p=0·0010). The most common grade 3 adverse events on (blinded) cediranib were hypertension (six [19%] of 31) and diarrhoea (two [6%]). 15 serious adverse reactions in 12 patients were reported; 12 of these reactions occurred on open-label cediranib, and the most common symptoms were dehydration (n=2), vomiting (n=2), and proteinuria (n=2). One probable treatment-related death (intracranial haemorrhage) occurred 41 days after starting open-label cediranib in a patient who was assigned to placebo in the masked phase. INTERPRETATION Given the high incidence of metastatic disease and poor long-term prognosis of ASPS, together with the lack of efficacy of conventional chemotherapy, our finding of significant clinical activity with cediranib in this disease is an important step towards the goal of long-term disease control for these young patients. Future clinical trials in ASPS are also likely to involve immune checkpoint inhibitors. FUNDING Cancer Research UK and AstraZeneca.",2019,"15 serious adverse reactions in 12 patients were reported; 12 of these reactions occurred on open-label cediranib, and the most common symptoms were dehydration (n=2), vomiting (n=2), and proteinuria (n=2).","['23 (48%) were female and the median age was 31 years (IQR 27-45', 'Between July 15, 2011, and July 29, 2016, of 48 participants recruited', 'participants who received at least one dose of study drug', 'Participants had to have no anti-cancer treatment within 4 weeks before trial entry, with exception of palliative radiotherapy', 'Patients were eligible if they were aged 16 years or older; metastatic ASPS that had progressed in the previous 6 months; had an ECOG performance status of 0-1; life expectancy of more than 12 weeks; and adequate bone marrow, hepatic, and renal function', 'patients with alveolar soft-part sarcoma (CASPS', 'recruited participants from 12 hospitals in the UK (n=7), Spain (n=3), and Australia (n=2']","['placebo', 'cediranib', 'Cediranib', 'conventional chemotherapy', 'placebo crossed over to cediranib', 'matching placebo tablets']","['15 serious adverse reactions', 'diarrhoea', 'percentage change in sum of target marker lesion diameters', 'Safety']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0206298', 'cui_str': 'European Viper'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0206657', 'cui_str': 'Alveolar Soft Part Sarcoma'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",48.0,0.68903,"15 serious adverse reactions in 12 patients were reported; 12 of these reactions occurred on open-label cediranib, and the most common symptoms were dehydration (n=2), vomiting (n=2), and proteinuria (n=2).","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: Ian.Judson@icr.ac.uk.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Morden', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Kilburn', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leahy', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Benson', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bhadri', 'Affiliation': ""Chris O'Brien Lifehouse, Sydney, NSW, Australia.""}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Campbell-Hewson', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Cubedo', 'Affiliation': 'Hospital Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Dangoor', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fox', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Hennig', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Jarman', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Joubert', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kernaghan', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'López Pousa', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse, Sydney, NSW, Australia.""}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Seddon', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Snowdon', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tattersall', 'Affiliation': ""Chris O'Brien Lifehouse, Sydney, NSW, Australia.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Toms', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martinez Trufero', 'Affiliation': 'Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30215-3'] 3368,31556911,Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial.,"Importance Standard adverse event (AE) reporting in oncology clinical trials has historically relied on clinician grading, which prior research has shown can lead to underestimation of rates of symptomatic AEs. Industry sponsors are beginning to implement in trials the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), which was developed to allow patients to self-report symptomatic AEs and improve the quality of symptomatic AE detection. Objectives To evaluate the feasibility of implementing PRO-CTCAE in a prespecified correlative analysis of the phase 3 COMET-2 trial and enumerate statistically significant between-group differences in symptomatic AEs using PRO-CTCAE and the CTCAE. Design, Setting, and Participants This correlative study of 119 men in the randomized, double-blind, placebo-controlled phase 3 COMET-2 trial with metastatic castration-resistant prostate cancer who had undergone at least 2 prior lines of systemic treatment was conducted from March 2012 to July 2014. Participants completed PRO-CTCAE items using an automated telephone system from home prior to treatment and every 3 weeks during treatment. Statistical analysis was performed from May 2018 to June 2019. Main Outcomes and Measures The proportion of patients who completed expected PRO-CTCAE self-reports was computed as a measure of feasibility. Results Among the 119 men in the study (median age, 65 years [range, 44-80 years]), 534 of 587 (91.0%) expected PRO-CTCAE self-reports were completed, with consistently high rates of completion throughout participation. Rates of self-report adherence were similar between groups (cabozantinib s-maleate, 286 of 317 [90.2%]; and mitoxantrone hydrochloride-prednisone, 248 of 270 [91.9%]). Of 12 measured, patient-reported PRO-CTCAE symptomatic AEs, 4 reached statistical significance when comparing the proportion of patients with at least 1 postbaseline score greater than 0 between groups (differences ranged from 20.1% to 34.1% with higher proportions in the cabozantinib group; all P < .05), and use of a method for accounting for preexisting symptoms at baseline yielded 7 AEs with statistically significant differences between groups (differences ranged from 20.5% to 41.2% with higher proportions in the cabozantinib group; all P < .05). In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs. Conclusions and Relevance PRO-CTCAE data collection was feasible and improved the accuracy of symptomatic AE detection in a phase 3 cancer trial. This analysis adds to mounting evidence of the feasibility and value of patient-reported AEs in oncology, which should be considered for inclusion in cancer trials that incorporate AE evaluation. Trial Registration ClinicalTrials.gov identifier: NCT01522443.",2019,"In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs. ","['119 men in the study (median age, 65 years [range, 44-80 years]), 534 of 587 (91.0%) expected PRO-CTCAE self-reports', '119 men', 'controlled phase 3 COMET-2 trial with metastatic castration-resistant prostate cancer who had undergone at least 2 prior lines of systemic treatment was conducted from March 2012 to July 2014']","['placebo', 'mitoxantrone hydrochloride-prednisone']",['Rates of self-report adherence'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700458', 'cui_str': 'Mitoxantrone Hydrochloride'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",119.0,0.207639,"In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs. ","[{'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Department of Medicine, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Antonia V', 'Initials': 'AV', 'LastName': 'Bennett', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gina L', 'Initials': 'GL', 'LastName': 'Mazza', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Thanarajasingam', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Schwab', 'Affiliation': 'Exelixis Inc, South San Francisco, California.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Weitzman', 'Affiliation': 'Independent Consultant, San Francisco, California.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Rogak', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}]",JAMA oncology,['10.1001/jamaoncol.2019.3332'] 3369,31924551,"Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study.","BACKGROUND Xpert MTB/RIF Ultra (Xpert Ultra) might have higher sensitivity than its predecessor, Xpert MTB/RIF (Xpert), but its role in tuberculous meningitis diagnosis is uncertain. We aimed to compare Xpert Ultra with Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. METHODS In this prospective, randomised, diagnostic accuracy study, adults (≥16 years) with suspected tuberculous meningitis from a single centre in Vietnam were randomly assigned to cerebrospinal fluid testing by either Xpert Ultra or Xpert at baseline and, if treated for tuberculous meningitis, after 3-4 weeks of treatment. Test performance (sensitivity, specificity, and positive and negative predictive values) was calculated for Xpert Ultra and Xpert and compared against clinical and mycobacterial culture reference standards. Analyses were done for all patients and by HIV status. FINDINGS Between Oct 16, 2017, and Feb 10, 2019, 205 patients were randomly assigned to Xpert Ultra (n=103) or Xpert (n=102). The sensitivities of Xpert Ultra and Xpert for tuberculous meningitis diagnosis against a reference standard of definite, probable, and possible tuberculous meningitis were 47·2% (95% CI 34·4-60·3; 25 of 53 patients) for Xpert Ultra and 39·6% (27·6-53·1; 21 of 53) for Xpert (p=0·56); specificities were 100·0% (95% CI 92·0-100·0; 44 of 44) and 100·0% (92·6-100·0; 48 of 48), respectively. In HIV-negative patients, the sensitivity of Xpert Ultra was 38·9% (24·8-55·1; 14 of 36) versus 22·9% (12·1-39·0; eight of 35) by Xpert (p=0·23). In HIV co-infected patients, the sensitivities were 64·3% (38·8-83·7; nine of 14) for Xpert Ultra and 76·9% (49·7-91·8; ten of 13) for Xpert (p=0·77). Negative predictive values were 61·1% (49·6-71·5) for Xpert Ultra and 60·0% (49·0-70·0) for Xpert. Against a reference standard of mycobacterial culture, sensitivities were 90·9% (72·2-97·5; 20 of 22 patients) for Xpert Ultra and 81·8% (61·5-92·7; 18 of 22) for Xpert (p=0·66); specificities were 93·9% (85·4-97·6; 62 of 66) and 96·9% (89·5-91·2; 63 of 65), respectively. Six (22%) of 27 patients had a positive test by Xpert Ultra after 4 weeks of treatment versus two (9%) of 22 patients by Xpert. INTERPRETATION Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. A negative Xpert Ultra or Xpert test does not rule out tuberculous meningitis. New diagnostic strategies are urgently required. FUNDING Wellcome Trust and the Foundation for Innovative New Diagnostics.",2020,"INTERPRETATION Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults.","['205 patients', 'HIV-uninfected and HIV-infected adults', 'adults (≥16 years) with suspected tuberculous meningitis from a single centre in Vietnam']","['cerebrospinal fluid testing by either Xpert Ultra or Xpert at baseline', 'Xpert Ultra with Xpert', 'Xpert Ultra (n=103) or Xpert', 'Xpert MTB/RIF Ultra versus Xpert MTB/RIF']","['Test performance (sensitivity, specificity, and positive and negative predictive values', 'Negative predictive values', 'sensitivity of Xpert Ultra']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0041318', 'cui_str': 'Tubercular Meningitis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]",[{'cui': 'C0007807'}],"[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",205.0,0.0910628,"INTERPRETATION Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: jdonovan@oucru.org.'}, {'ForeName': 'Do Dang Anh', 'Initials': 'DDA', 'LastName': 'Thu', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Hoan', 'Initials': 'NH', 'LastName': 'Phu', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu Thi Mong', 'Initials': 'VTM', 'LastName': 'Dung', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Phu', 'Initials': 'TP', 'LastName': 'Quang', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ho Dang Trung', 'Initials': 'HDT', 'LastName': 'Nghia', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Pham Kieu Nguyet', 'Initials': 'PKN', 'LastName': 'Oanh', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Bao', 'Initials': 'TB', 'LastName': 'Nhu', 'Affiliation': 'Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu Thi Ngoc', 'Initials': 'VTN', 'LastName': 'Ha', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu Thi Ty', 'Initials': 'VTT', 'LastName': 'Hang', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dong Huu Khanh', 'Initials': 'DHK', 'LastName': 'Trinh', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Geskus', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Le Van', 'Initials': 'LV', 'LastName': 'Tan', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen Thuy Thuong', 'Initials': 'NTT', 'LastName': 'Thuong', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30649-8'] 3370,31948665,Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation.,"Little information is available concerning the usefulness of electrophysiological confirmation followed by totally thoracoscopic ablation. This study aimed to examine whether postprocedural electrophysiological confirmation is always necessary after totally thoracoscopic ablation (TTA) in patients with isolated persistent atrial fibrillation. Forty-five patients with isolated persistent atrial fibrillation were randomized into 2 groups those who received routine electrophysiological confirmation and additional catheter ablation after totally thoracoscopic ablation (the hybrid group [n = 22]) and those who did not (the TTA group [n = 23]). Electrophysiological study was performed 4 or 5 days after surgery. No early or late mortality occurred. In the hybrid group, 5 patients (23%, 5/22) required additional ablation due to residual potential in the left atrium. At a year postoperatively, normal sinus rhythm was observed in 89% of patients (40/45) and similar in both groups (Odds ratio 0.80, 95% confidence interval 0.32 to 1.99). During follow-up, sinus rhythm was maintained in 16 patients (70%) in the TTA group without additional catheter ablation, which was similar (p = 0.920) to the results in the hybrid group (n = 15, 68.2%). Event-free survival rate at 12 months did not differ between groups (TTA group vs hybrid group, 78% vs 77%; p = 0.633). In simple Cox regression analysis, preoperative left atrium volume index was associated with atrial arrhythmia (p = 0.030, hazards ratio 1.087, 95% confidence interval 1.01-1.18). In conclusion, thoracoscopic ablation provided good 1-year durability in patients with isolated persistent AF irrespective of postprocedural electrophysiological confirmation. Seventy-percent of the TTA group did not need additional catheter ablation.",2020,"Event-free survival rate at 12 months did not differ between groups (TTA group vs hybrid group, 78% vs 77%; p = 0.633).","['Forty-five patients with isolated persistent atrial fibrillation', 'patients with isolated persistent AF irrespective of postprocedural electrophysiological confirmation', 'Persistent Atrial Fibrillation', 'patients with isolated persistent atrial fibrillation']","['TTA group without additional catheter ablation', 'totally thoracoscopic ablation (TTA', 'Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation', 'thoracoscopic ablation', 'routine electrophysiological confirmation and additional catheter ablation after totally thoracoscopic ablation (the hybrid group [n\u202f=\u202f22]) and those who did not (the TTA', 'TTA']","['atrial arrhythmia', 'preoperative left atrium volume index', 'need additional catheter ablation', 'normal sinus rhythm', '1-year durability', 'Event-free survival rate', 'late mortality']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0225860', 'cui_str': 'Left Atrium'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0232202', 'cui_str': 'Normal sinus rhythm (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",45.0,0.0331554,"Event-free survival rate at 12 months did not differ between groups (TTA group vs hybrid group, 78% vs 77%; p = 0.633).","[{'ForeName': 'Min Suk', 'Initials': 'MS', 'LastName': 'Choi', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Dongguk University Ilsan Hospital, Dongguk University School of Medicine, Goyang, Gyeonggi, South Korea.'}, {'ForeName': 'Young Keun', 'Initials': 'YK', 'LastName': 'On', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Seop', 'Initials': 'DS', 'LastName': 'Jeong', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: opheart1@gmail.com.'}, {'ForeName': 'Kyoung-Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'June Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Keumhee C', 'Initials': 'KC', 'LastName': 'Carriere', 'Affiliation': 'Biostatistics and Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.12.046'] 3371,31182528,"First-Time-in-Human Study and Prediction of Early Bactericidal Activity for GSK3036656, a Potent Leucyl-tRNA Synthetase Inhibitor for Tuberculosis Treatment.","This first-time-in-human (FTIH) study evaluated the safety, tolerability, pharmacokinetics, and food effect of single and repeat oral doses of GSK3036656, a leucyl-tRNA synthetase inhibitor. In part A, GSK3036656 single doses of 5 mg (fed and fasted), 15 mg, and 25 mg and placebo were administered. In part B, repeat doses of 5 and 15 mg and placebo were administered for 14 days once daily. GSK3036656 showed dose-proportional increase following single-dose administration and after dosing for 14 days. The maximum concentration of drug in serum ( C max ) and area under the concentration-time curve from 0 h to the end of the dosing period (AUC 0-τ ) showed accumulation with repeated administration of approximately 2- to 3-fold. Pharmacokinetic parameters were not altered in the presence of food. Unchanged GSK3036656 was the only drug-related component detected in plasma and accounted for approximately 90% of drug-related material in urine. Based on total drug-related material detected in urine, the minimum absorbed doses after single (25 mg) and repeat (15 mg) dosing were 50 and 78%, respectively. Unchanged GSK3036656 represented at least 44% and 71% of the 25- and 15-mg doses, respectively. Clinical trial simulations were performed to guide dose escalation during the FTIH study and to predict the GSK3036656 dose range that produces the highest possible early bactericidal activity (EBA 0-14 ) in the prospective phase II trial, with consideration of the predefined exposure limit. GSK3036656 was well tolerated after single and multiple doses, with no reports of serious adverse events. (This study has been registered at ClinicalTrials.gov under identifier NCT03075410.).",2019,GSK3036656 was well tolerated after single and multiple doses with no reports of serious adverse events.,[],['placebo'],"['safety, tolerability, pharmacokinetics and food effect', 'C max and AUC (0-τ', 'Pharmacokinetic parameters', 'tolerated']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0465602,GSK3036656 was well tolerated after single and multiple doses with no reports of serious adverse events.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tenero', 'Affiliation': 'GlaxoSmithKline Clinical Pharmacology Modeling and Simulation, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Geo', 'Initials': 'G', 'LastName': 'Derimanov', 'Affiliation': 'GlaxoSmithKline Clinical Pharmacology and Experimental Medicine, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carlton', 'Affiliation': 'GlaxoSmithKline Biostatistics, Stockley Park, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tonkyn', 'Affiliation': 'GlaxoSmithKline Global Sciences and Delivery, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'GlaxoSmithKline Safety and Medical Governance, Stockley Park, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cozens', 'Affiliation': 'GlaxoSmithKline, Translation Project Specialist Team, Ware, Hertfordshire, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gresham', 'Affiliation': 'GlaxoSmithKline, Mechanistic Safety and Disposition, Ware, Hertfordshire, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Gaudion', 'Affiliation': 'Hammersmith Medicines Research, London, United Kingdom.'}, {'ForeName': 'Adeep', 'Initials': 'A', 'LastName': 'Puri', 'Affiliation': 'Hammersmith Medicines Research, London, United Kingdom.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Muliaditan', 'Affiliation': 'GlaxoSmithKline DMPK Modelling, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Rullas-Trincado', 'Affiliation': 'GlaxoSmithKline Global Health, TBDPU, Tres Cantos, Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Mendoza-Losana', 'Affiliation': 'GlaxoSmithKline Global Health, TBDPU, Tres Cantos, Madrid, Spain.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Skingsley', 'Affiliation': 'GlaxoSmithKline Global Health Clinical Drug Development, Stockley Park, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barros-Aguirre', 'Affiliation': 'GlaxoSmithKline Global Health, TBDPU, Tres Cantos, Madrid, Spain david.a.barros@gsk.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00240-19'] 3372,31134713,The academic outcomes of working memory and metacognitive strategy training in children: A double-blind randomized controlled trial.,"Working memory training has been shown to improve performance on untrained working memory tasks in typically developing children, at least when compared to non-adaptive training; however, there is little evidence that it improves academic outcomes. The lack of transfer to academic outcomes may be because children are only learning skills and strategies in a very narrow context, which they are unable to apply to other tasks. Metacognitive strategy interventions, which promote metacognitive awareness and teach children general strategies that can be used on a variety of tasks, may be a crucial missing link in this regard. In this double-blind randomized controlled trial, 95 typically developing children aged 9-14 years were allocated to three cognitive training programmes that were conducted daily after-school. One group received Cogmed working memory training, another group received concurrent Cogmed and metacognitive strategy training, and the control group received adaptive visual search training, which better controls for expectancy and motivation than non-adaptive training. Children were assessed on four working memory tasks, reading comprehension, and mathematical reasoning before, immediately after, and 3 months after training. Working memory training improved working memory and mathematical reasoning relative to the control group. The improvements in working memory were maintained 3 months later, and these were significantly greater for the group that received metacognitive strategy training, compared to working memory training alone. Working memory training is a potentially effective educational intervention when provided in addition to school; however, future research will need to investigate ways to maintain academic improvements long term and to optimize metacognitive strategy training to promote far-transfer. A video abstract of this article can be viewed at https://youtu.be/-7MML48ZFgw.",2020,"The improvements in working memory were maintained 3 months later, and these were significantly greater for the group that received metacognitive strategy training, compared to working memory training alone.","['children', '95 typically developing children aged 9-14\xa0years']","['cognitive training programmes', 'metacognitive strategy training', 'Cogmed working memory training, another group received concurrent Cogmed and metacognitive strategy training, and the control group received adaptive visual search training, which better controls for expectancy and motivation than non-adaptive training', 'Metacognitive strategy interventions', 'working memory and metacognitive strategy training', 'Working memory training']","['working memory and mathematical reasoning relative', 'working memory', 'working memory tasks, reading comprehension, and mathematical reasoning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",95.0,0.0643129,"The improvements in working memory were maintained 3 months later, and these were significantly greater for the group that received metacognitive strategy training, compared to working memory training alone.","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Milton', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Mohammod', 'Initials': 'M', 'LastName': 'Mostazir', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Adlam', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.'}]",Developmental science,['10.1111/desc.12870'] 3373,30925783,Executive Function Performance in Young Adults When Cycling at an Active Workstation: An fNIRS Study.,"BACKGROUND This study aimed to investigate the effects of self-paced cycling at an active workstation on executive functions and cortical activity. METHODS In a crossover study design, 37 young adults (45.9% females) were randomly assigned to the following two task conditions: (1) performing cognitive tests during sitting, (2) performing cognitive tests while cycling at an active workstation. Executive functions were assessed by the Stroop color and word test and the task-switching paradigm. Cortical activity was monitored using a multi-channel functional near-infrared spectroscopy (fNIRS) system. RESULTS The behavioral results showed that there were no significant differences on the Stroop interference effects ( P = 0.66) between the sitting and the cycling conditions. In all probability, no differences on the global switch costs ( P = 0.90) and local switch costs ( P = 0.67) were observed between the sitting and the cycling conditions. For the fNIRS results, the oxygenated hemoglobin (oxy-Hb) in response to the Stroop interference in channels 5, 10, and 12 were decreased during the cycling condition (all Ps < 0.05, FDR-corrected). Conversely, the oxy-Hb associated with the global switch costs in channels 3, 29, and 31 were increased during the cycling condition (all Ps < 0.05, FDR-corrected). CONCLUSIONS The findings indicated that behavioral performances on executive functions were not affected by cycling at an active workstation, while cognitive resources were reallocated during cycling at an active workstation.",2019,The behavioral results showed that there were no significant differences on the Stroop interference effects ( P = 0.66) between the sitting and the cycling conditions.,"['Young Adults', '37 young adults (45.9% females']","['cognitive tests during sitting, (2) performing cognitive tests while cycling at an active workstation']","['local switch costs', 'Executive functions', 'Executive Function Performance', 'global switch costs', 'Stroop interference effects', 'Cortical activity', 'executive functions']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1736830', 'cui_str': 'Workstation (physical object)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",37.0,0.0368394,The behavioral results showed that there were no significant differences on the Stroop interference effects ( P = 0.66) between the sitting and the cycling conditions.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. taohuang@sjtu.edu.cn.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Gu', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. sjtuguqian@sjtu.edu.cn.'}, {'ForeName': 'Zhangyan', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. zhangyandeng@sjtu.edu.cn.'}, {'ForeName': 'Chilun', 'Initials': 'C', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. henry41202@yahoo.com.tw.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. xy0927@sjtu.edu.cn.'}, {'ForeName': 'Jimeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. simon2017@sjtu.edu.cn.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Lifestyle (Mind-Body Movement) Research Center, College of Sports Science, Shenzhen University, Shenzhen 518060, China. liyezou123@gmail.com.'}, {'ForeName': 'Zuosong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. zschen1971@126.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China. wangkunz@sjtu.edu.cn.'}]",International journal of environmental research and public health,['10.3390/ijerph16071119'] 3374,32150017,Can Benign Paroxysmal Positional Vertigo Be Treated in a One Session?,"OBJECTIVE To determine the reliability and safety of posterior canal BPPV (pc-BPPV) treatment with subsequent assessment of the effectiveness of the maneuver in a single session, compared to the classic weekly procedure. METHOD A prospective study of two randomized groups of unilateral pc-BPPV was performed: a weekly management group (27 patients) and single-session treatment group (26 patients). The number of maneuvers required to clear pc-BPPV, incidence of side effects (re-entries and canal conversions), and recurrence rates were compared. RESULTS There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups. Two re-entries were diagnosed in the single-session group, and both were easily and successfully treated. Three early recurrences were found in the single-session group and one spontaneous recovery was encountered in the weekly group. Time required to discharge patients to follow-up was significantly reduced in the single-session group. CONCLUSION Managing pc-BPPV in one session is safe and reliable, resulting in fewer visits to outpatient clinics and optimization of treatment strategies.",2020,"There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups.",[],"['unilateral pc-BPPV', 'posterior canal BPPV (pc-BPPV']","['number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate', 'number of maneuvers required to clear pc-BPPV, incidence of side effects (re-entries and canal conversions), and recurrence rates', 'Time required to discharge patients to follow-up', 'spontaneous recovery']",[],"[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]",,0.0413024,"There were no statistically significant differences in the number of maneuvers needed to resolve pc-BPPV, the incidence of side effects, or the recurrence rate between the two groups.","[{'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Pérez-Guillén', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario La Fe, Valencia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Franco-Gutiérrez', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'Maria Teresa Gil-', 'Initials': 'MTG', 'LastName': 'Aguilar', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario Marqués de Valdecilla, Santander.'}, {'ForeName': 'Enrique García-', 'Initials': 'EG', 'LastName': 'Zamora', 'Affiliation': 'Otoneurology Section, ENT Department, Hospital Universitario La Fe, Valencia.'}, {'ForeName': 'Paz', 'Initials': 'P', 'LastName': 'Pérez-Vázquez', 'Affiliation': 'ENT Department, Hospital Universitario de Cabueñes, Gijón, Spain.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002621'] 3375,32111383,The effects of nurse-led health coaching on health-related quality of life and clinical health outcomes among frequent attenders: A quasi-experimental study.,"OBJECTIVE To evaluate the effects of the nurse-led health coaching on health-related quality of life and clinical health outcomes among frequent attenders in primary healthcare. METHODS A quasi-experimental study design. A total of 110 patients were enrolled in the study. The experimental group (n = 52) received nurse-led health coaching and the control group (n = 58) received the usual care at primary health care centres in Finland. The data were collected before the intervention and 12 months via a questionnaire of health-related quality of life and clinical health outcomes as measured by health-coaching nurses. RESULTS This study found frequent attenders have low health-related quality of life. The nurse-led health coaching showed no differences in health-related quality of life between the experimental and control groups. However, the nurse-led health coaching had statistically significant effects on the blood pressure and health-related quality of life among the experimental participants, especially in emotional role limitation and energy. CONCLUSIONS This study suggests that nurse-led health coaching may lead to an improvement in the health-related quality of life and blood pressure among frequent attenders. PRACTICE IMPLICATIONS The health-coaching sessions with own health-coaching nurses and action plans support the frequent attenders´ health promotion goals and implementation.",2020,The nurse-led health coaching showed no differences in health-related quality of life between the experimental and control groups.,"['A total of 110 patients were enrolled in the study', 'frequent attenders', 'frequent attenders in primary healthcare']","['nurse-led health coaching', 'nurse-led health coaching and the control group (n\u202f=\u202f58) received the usual care at primary health care centres in Finland']","['health-related quality of life and clinical health outcomes', 'quality of life and clinical health outcomes', 'health-related quality of life', 'blood pressure and health-related quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",110.0,0.024312,The nurse-led health coaching showed no differences in health-related quality of life between the experimental and control groups.,"[{'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Kivelä', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu Finland University of Oulu, P.O.Box 5000, 90014, Finland. Electronic address: kirsi.kivela@dnainternet.net.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Elo', 'Affiliation': 'Lapland University of Applied Sciences, Kemi, Finland. Electronic address: satu.elo@lapinamk.fi.'}, {'ForeName': 'Helvi', 'Initials': 'H', 'LastName': 'Kyngäs', 'Affiliation': 'University of Oulu University Hospital, Medical Research Center Oulu, Oulu, Finland. Electronic address: helvi.kyngas@oulu.fi.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kääriäinen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu University Hospital, Oulu, Finland. Electronic address: maria.kaariainen@oulu.fi.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.026'] 3376,31707266,Predictors of adherence to nicotine replacement therapy: Machine learning evidence that perceived need predicts medication use.,"BACKGROUND Nonadherence to smoking cessation medication is a frequent problem. Identifying pre-quit predictors of nonadherence may help explain nonadherence and suggest tailored interventions to address it. AIMS Identify and characterize subgroups of smokers based on adherence to nicotine replacement therapy (NRT). METHOD Secondary classification tree analyses of data from a 2-arm randomized controlled trial of Recommended Usual Care (R-UC, n = 315) versus Abstinence-Optimized Treatment (A-OT, n = 308) were conducted. R-UC comprised 8 weeks of nicotine patch plus brief counseling whereas A-OT comprised 3 weeks of pre-quit mini-lozenges, 26 weeks of nicotine patch plus mini-lozenges, 11 counseling contacts, and 7-11 automated reminders to use medication. Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges. RESULTS Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use. Greater quitting motivation and confidence, and believing that stop smoking medication was safe and easy to use were associated with greater adherence. CONCLUSION Adherence was especially high in those who were more dependent and more exposed to smoking triggers. Quitting motivation and confidence predicted greater adherence, while negative beliefs about medication safety and acceptability predicted worse adherence. Results suggest that adherent use of medication may reflect a rational appraisal of the likelihood that one will need medication and will benefit from it.",2019,"Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges. RESULTS Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use.",[],"['Usual Care (R-UC, n\u202f=\u202f315) versus Abstinence-Optimized Treatment', 'nicotine replacement therapy (NRT', 'nicotine patch plus brief counseling', 'nicotine patch plus mini-lozenges']",['Adherence'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]",[],315.0,0.0202661,"Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges. RESULTS Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use.","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA. Electronic address: nkim86@ctri.wisc.edu.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Wei-Yin', 'Initials': 'WY', 'LastName': 'Loh', 'Affiliation': 'Department of Statistics, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107668'] 3377,32159711,Effectiveness of an internet-based self-guided program to treat depression in a sample of Brazilian users: a study protocol.,"Although psychological treatments for depressive disorders are available, they are often expensive or inaccessible for many. Web-based interventions that require minimal or no contact with therapists have been shown effective. To the best of our knowledge, no study using this treatment format has been conducted in Brazil. The Deprexis program was designed using empirically established principles of cognitive-behavioral therapy to reduce depressive symptoms. The objective of this study was to evaluate the effectiveness of Deprexis in Brazil. This randomized controlled trial will include 128 Brazilians with clinically significant depression symptoms or who have been diagnosed with depressive disorder (major depressive disorder or dysthymia), recruited over the internet (Brazilian forums, social networks, or e-mail lists). Individuals with other psychiatric diagnoses that require significant attention (e.g., bipolar disorder, psychosis) will not be included in the trial. Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks). Participants will be able to obtain other treatment types in addition to the online intervention. If found effective, this web-based intervention would increase the evidence-based care options for depression treatment in Brazil. RBR-6kk3bx, UTN U1111-1212-8998.",2020,Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks).,"['128 Brazilians with clinically significant depression symptoms or who have been diagnosed with depressive disorder (major depressive disorder or dysthymia), recruited over the internet (Brazilian forums, social networks, or e-mail lists', 'Individuals with other psychiatric diagnoses', 'a sample of Brazilian users']","['usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis', 'internet-based self-guided program']",[],"[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0013415', 'cui_str': 'Dysthymic Disorder'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0376338', 'cui_str': 'Diagnosis, Psychiatric'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],128.0,0.130412,Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks).,"[{'ForeName': 'Rodrigo T', 'Initials': 'RT', 'LastName': 'Lopes', 'Affiliation': 'Universidade Católica de Petrópolis, RJ, Brazil.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Gaia Group, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Svacina', 'Affiliation': 'Universidade Católica de Petrópolis, RJ, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0582'] 3378,31154811,"Implementation and impact of a technology-based HIV risk-reduction intervention among Thai men who have sex with men using ""Vialogues"": a randomized controlled trial.","We conducted a randomized control trial to evaluate the impact of a novel technology-based intervention on HIV risks and condom use behaviors among Thai men who have sex with men (MSM). Between April 2016 and August 2017, participants aged 18 years and above, and having engaged in unprotected sex in past six months were randomly assigned to control and intervention arm, and received HIV testing at baseline, month 6 and 12. Intervention arm participants engaged in 12-monthly HIV/STI prevention educational sessions delivered via Vialogues.com. Of 76 MSM enrolled, 37 were randomized to intervention and 39 to control arm. Median age was 28 (IQR 24-32) years. Thirty-three (89.2%) intervention arm participants completed all 12-monthly Vialogues sessions. At month 12, intervention arm had higher retention rate ( p  = 0.029) and higher median percentage of condom use for anal intercourse ( p  = 0.023) versus control arm. Over the 12-month period, intervention arm reported significant reduction in self-perceived HIV risk ( p  = 0.001), popper usage ( p  = 0.002), median number of sexual partners ( p  = 0.003), and increased median condom use percentage ( p  = 0.006). Our study highlights that ""Vialogues"" intervention significantly reduced number of sexual partners and condomless anal intercourse rates among Thai MSM, and has positive implications for reducing epidemic among key populations.",2020,"At month 12, intervention arm had higher retention rate ( p  = 0.029) and higher median percentage of condom use for anal intercourse ( p  = 0.023) versus control arm.","['Between April 2016 and August 2017, participants aged 18 years and above, and having engaged in unprotected sex in past six months', 'Thai men who have sex with men using ""Vialogues', 'Thai men who have sex with men (MSM', 'Median age was 28 (IQR 24-32) years']","['novel technology-based intervention', 'Intervention arm participants engaged in 12-monthly HIV/STI prevention educational sessions delivered via Vialogues.com', 'Vialogues"" intervention', 'technology-based HIV risk-reduction intervention']","['self-perceived HIV risk', 'HIV risks and condom use behaviors', 'sexual partners and condomless anal intercourse rates', 'higher retention rate', 'median percentage of condom use for anal intercourse', 'median number of sexual partners', 'median condom use percentage']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0556463', 'cui_str': 'Number of sexual partners (observable entity)'}]",76.0,0.0911471,"At month 12, intervention arm had higher retention rate ( p  = 0.029) and higher median percentage of condom use for anal intercourse ( p  = 0.023) versus control arm.","[{'ForeName': 'Tarandeep', 'Initials': 'T', 'LastName': 'Anand', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Chattiya', 'Initials': 'C', 'LastName': 'Nitpolprasert', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Jureeporn', 'Initials': 'J', 'LastName': 'Jantarapakde', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Ratchadaporn', 'Initials': 'R', 'LastName': 'Meksena', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Sangusa', 'Initials': 'S', 'LastName': 'Phomthong', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Petchfa', 'Initials': 'P', 'LastName': 'Phoseeta', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Praphan', 'Initials': 'P', 'LastName': 'Phanuphak', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}]",AIDS care,['10.1080/09540121.2019.1622638'] 3379,31757774,"Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial.","BACKGROUND Enterotoxigenic Escherichia coli causes diarrhoea, leading to substantial mortality and morbidity in children, but no specific vaccine exists. This trial tested an oral, inactivated, enterotoxigenic E coli vaccine (ETVAX), which has been previously shown to be safe and highly immuongenic in Swedish and Bangladeshi adults. We tested the safety and immunogenicity of ETVAX, consisting of four E coli strains overexpressing the most prevalent colonisation factors (CFA/I, CS3, CS5, and CS6) and a toxoid (LCTBA) administered with or without a double-mutant heat-labile enterotoxin (dmLT) as an adjuvant, in Bangladeshi children. METHODS We did a randomised, double-blind, placebo-controlled, dose-escalation, age-descending, phase 1/2 trial in Dhaka, Bangladesh. Healthy children in one of three age groups (24-59 months, 12-23 months, and 6-11 months) were eligible. Children were randomly assigned with block randomisation to receive either ETVAX, with or without dmLT, or placebo. ETVAX (half [5·5 × 10 10 cells], quarter [2·5 × 10 10 cells], or eighth [1·25 × 10 10 cells] adult dose), with or without dmLT adjuvant (2·5 μg, 5·0 μg, or 10·0 μg), or placebo were administered orally in two doses 2 weeks apart. Investigators and participants were masked to treatment allocation. The primary endpoint was safety and tolerability, assessed in all children who received at least one dose of vaccine. Antibody responses to vaccine antigens, defined as at least a two-times increase in antibody levels between baseline and post-immunisation, were assessed as secondary endpoints. This trial is registered with ClinicalTrials.gov, NCT02531802. FINDINGS Between Dec 7, 2015, and Jan 10, 2017, we screened 1500 children across the three age groups, of whom 430 were enrolled and randomly assigned to the different treatment groups (130 aged 24-59 months, 100 aged 12-23 months, and 200 aged 6-11 months). All participants received at least one dose of vaccine. No solicited adverse events occurred that were greater than moderate in severity, and most were mild. The most common solicited event was vomiting (ten [8%] of 130 patients aged 24-59 months, 13 [13%] of 100 aged 12-23 months, and 29 [15%] of 200 aged 6-11 months; mostly of mild severity), which appeared related to dose and age. The addition of dmLT did not modify the safety profile. Three serious adverse events occurred but they were not considered related to the study drug. Mucosal IgA antibody responses in lymphocyte secretions were detected against all primary vaccine antigens (CFA/I, CS3, CS5, CS6, and the LCTBA toxoid) in most participants in the two older age groups, whereas such responses to four of the five antigens were less frequent and of lower magnitude in infants aged 6-11 months than in older children. Faecal secretory IgA immune responses were recorded against all vaccine antigens in infants aged 6-11 months. 78 (56%) of 139 infants aged 6-11 months who were vaccinated developed mucosal responses against at least three of the vaccine antigens versus 14 (29%) of 49 of the infants given placebo. Addition of the adjuvant dmLT enhanced the magnitude, breadth, and kinetics (based on number of responders after the first dose of vaccine) of immune responses in infants. INTERPRETATION The encouraging safety and immunogenicity of ETVAX and benefit of dmLT adjuvant in young children support its further assessment for protective efficacy in children in enterotoxigenic E coli-endemic areas. FUNDING PATH (Bill & Melinda Gates Foundation and the UK's Department for International Development), the Swedish Research Council, and The Swedish Foundation for Strategic Research.",2020,Mucosal IgA antibody responses in lymphocyte secretions were detected against all primary vaccine antigens (,"['Swedish and Bangladeshi adults', '78 (56%) of 139 infants aged 6-11 months', 'Bangladeshi children and infants', 'Healthy children in one of three age groups (24-59 months, 12-23 months, and 6-11 months) were eligible', 'Bangladeshi children', 'infants', 'young children', 'Between Dec 7, 2015, and Jan 10, 2017, we screened 1500 children across the three age groups, of whom 430 were enrolled and randomly assigned to the different treatment groups (130 aged 24-59 months, 100 aged 12-23 months, and 200 aged 6-11 months', 'children in enterotoxigenic E coli-endemic areas']","['ETVAX, with or without dmLT, or placebo', 'enterotoxigenic Escherichia coli vaccine ETVAX', 'dmLT adjuvant', 'ETVAX', 'placebo', 'dmLT adjuvant (2·5 μg, 5·0 μg, or 10·0 μg), or placebo', 'vaccine', 'toxoid (LCTBA) administered with or without a double-mutant heat-labile enterotoxin (dmLT', 'inactivated, enterotoxigenic E coli vaccine (ETVAX']","['mucosal responses', 'solicited adverse events', 'Safety and immunogenicity', 'magnitude, breadth, and kinetics', 'vomiting', 'antibody levels', 'Faecal secretory IgA immune responses', 'Mucosal IgA antibody responses', 'serious adverse events', 'safety and tolerability']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0580797', 'cui_str': 'E coli, Enterotoxigenic'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0580797', 'cui_str': 'E coli, Enterotoxigenic'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0040555', 'cui_str': 'Toxoids'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0014372', 'cui_str': 'Enterotoxins'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020838', 'cui_str': 'Secretory IgA'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",1500.0,0.671173,Mucosal IgA antibody responses in lymphocyte secretions were detected against all primary vaccine antigens (,"[{'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Marjahan', 'Initials': 'M', 'LastName': 'Akhtar', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Taufiqur R', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohiul I', 'Initials': 'MI', 'LastName': 'Chowdhury', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tasnuva', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tanzeem A', 'Initials': 'TA', 'LastName': 'Rafique', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Arifuzzaman', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Sadia I A', 'Initials': 'SIA', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Khanam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lundgren', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wiklund', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kaim', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Löfstrand', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Carlin', 'Affiliation': 'Scandinavian Biopharma, Solna, Sweden.'}, {'ForeName': 'A Louis', 'Initials': 'AL', 'LastName': 'Bourgeois', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Maier', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wierzba', 'Affiliation': 'PATH, Washington DC, USA; Wake Forest School of Medicine, Section on Infectious Diseases, Department of Internal Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Walker', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Ann-Mari', 'Initials': 'AM', 'LastName': 'Svennerholm', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden. Electronic address: ann-mari.svennerholm@microbio.gu.se.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30571-7'] 3380,30674917,"Metabolic phenotype of breast-fed infants, and infants fed standard formula or bovine MFGM supplemented formula: a randomized controlled trial.","Formula-fed (FF) infants exhibit a different metabolic profile than breast-fed (BF) infants. Two potential mechanisms are the higher protein level in formula compared with breast milk and the removal of the milk fat and associated milk fat globule membranes (MFGM) during production of infant formula. To determine whether MFGM may impact metabolism, formula-fed infants were randomly assigned to receive either an MFGM isolate-supplemented experimental formula (EF) or a standard formula (SF) from 2 until 6 months and compared with a BF reference group. Infants consuming EF had higher levels of fatty acid oxidation products compared to infants consuming SF. Although the protein level in the study formula was approximately 12 g/L (lower than most commercial formulas), a metabolic difference between FF and BF remained such that FF infants had higher levels of amino acid catabolism by-products and a low efficiency of amino acid clearance (preference for protein metabolism). BF infants had higher levels of fatty acid oxidation products (preference for fat metabolism). These unique, energy substrate-driven metabolic outcomes did not persist after diet was shifted to weaning foods and appeared to be disrupted by complementary feeding. Our results suggest that MFGM may have a role in directing infant metabolism.",2019,Infants consuming EF had higher levels of fatty acid oxidation products compared to infants consuming SF.,"['Metabolic phenotype of breast-fed infants, and infants fed']","['MFGM isolate-supplemented experimental formula (EF) or a standard formula (SF', 'standard formula or bovine MFGM supplemented formula', 'MFGM']",['fatty acid oxidation products'],"[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]",,0.132024,Infants consuming EF had higher levels of fatty acid oxidation products compared to infants consuming SF.,"[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Parenti', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Grip', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, SE 901 85 Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Domellöf', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, SE 901 85 Umeå University, Umeå, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lönnerdal', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Hernell', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, SE 901 85 Umeå University, Umeå, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Timby', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, SE 901 85 Umeå University, Umeå, Sweden.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Slupsky', 'Affiliation': 'Department of Nutrition, University of California Davis, One Shields Ave, Davis, CA, 95616, USA. cslupsky@ucdavis.edu.'}]",Scientific reports,['10.1038/s41598-018-36292-5'] 3381,28275830,Benefits of varenicline vs. bupropion for smoking cessation: a Bayesian analysis of the interaction of reward sensitivity and treatment.,"RATIONALE We have shown that differences in the level of neural activation to stimuli associated with smoking vs. natural rewards, a biomarker related to reward sensitivity, predict treatment outcome. OBJECTIVES This paper examined whether this biomarker moderates the impact of bupropion or varenicline on smoking cessation. METHODS Prior to treatment randomization, smokers (N = 180) in a placebo-controlled trial using bupropion and varenicline completed event-related potential recording (late positive potential, LPP) while viewing pleasant (P), cigarette (C)-related, and other pictures. We used Bayesian models to estimate the probability of interaction between treatment and the LPP for both efficacy and comparative effectiveness analyses. RESULTS Efficacy analysis showed that smokers with more neural activation to pleasant vs. cigarette-related stimuli (P > C) had a 98-99% chance of achieving greater abstinence than placebo (OR >1.00), using either medication from the end of treatment (EOT, primary outcome) through the 3-month follow-up. Relative to placebo, smokers with higher activation to cigarette-related vs. pleasant stimuli (C > P) had a 99% chance of increased benefit from varenicline at both time points (OR >1), but only 67 and 43% with bupropion at the EOT and 3-month follow-up, respectively. Comparative effectiveness analysis found that smokers with the C > P activation pattern had a 95-98% chance of benefit from varenicline vs. bupropion, while P > C smokers had a 50-58% chance of similar improvement with varenicline at the EOT and 3 months. CONCLUSIONS Varenicline appears to be the treatment of choice for smokers with the C > P pattern of neural activation, while for those showing P > C, varenicline and bupropion have similar efficacy.",2017,"Relative to placebo, smokers with higher activation to cigarette-related vs. pleasant stimuli (C > P) had a 99% chance of increased benefit from varenicline at both time points (OR >1), but only 67 and 43% with bupropion at the EOT and 3-month follow-up, respectively.","['smokers with the C\xa0', 'smoking cessation', 'Prior to treatment randomization, smokers (N\xa0']","['Varenicline', 'bupropion and varenicline', 'placebo', 'varenicline', 'varenicline vs. bupropion', 'varenicline and bupropion', 'bupropion or varenicline']","['neural activation to pleasant vs. cigarette-related stimuli', 'completed event-related potential recording (late positive potential, LPP) while viewing pleasant (P), cigarette (C)-related, and other pictures']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}]",,0.0316353,"Relative to placebo, smokers with higher activation to cigarette-related vs. pleasant stimuli (C > P) had a 99% chance of increased benefit from varenicline at both time points (OR >1), but only 67 and 43% with bupropion at the EOT and 3-month follow-up, respectively.","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Unit 1330, PO Box 301439, Houston, TX, 77230-1439, USA. pcinciri@mdanderson.org.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Green', 'Affiliation': 'The University of Texas at Houston Health Sciences Center, Houston, TX, USA.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Unit 1330, PO Box 301439, Houston, TX, 77230-1439, USA.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Karam-Hage', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Unit 1330, PO Box 301439, Houston, TX, 77230-1439, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Engelmann', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Unit 1330, PO Box 301439, Houston, TX, 77230-1439, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Minnix', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Unit 1330, PO Box 301439, Houston, TX, 77230-1439, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Versace', 'Affiliation': 'University of Oklahoma Health Sciences Center and Oklahoma Tobacco Research Center, Oklahoma City, USA.'}]",Psychopharmacology,['10.1007/s00213-017-4580-2'] 3382,30317532,Repetitive transcranial magnetic stimulation for treatment of tardive syndromes: double randomized clinical trial.,"Tardive syndromes (TDS) typically manifest 3 months or later after exposure to antipsychotic drugs, and unfortunately have no satisfactory medical treatment. We explored the possibility of using therapeutic repetitive transcranial magnetic stimulation (rTMS). Twenty-six patients were allocated to receive real or sham rTMS over the hand/arm area of motor cortex (M1). Each received a daily total of 2000 rTMS pulses (20 Hz at 100% rMT: 1000 stimuli per hemisphere) for 10 consecutive days. Outcome was assessed using the Abnormal Involuntary Movement Scale (AIMS) and TMS measures of M1 excitability. Three patients in the sham group failed to complete the study. At baseline, there was no significant difference between the groups in age, sex distribution, duration of illness, AIMS score and drug treatment. rTMS improved symptoms in both groups. However, there was a greater reduction in the AIMS score of the real rTMS group compared with the sham group (real, 8.3 ± 1.7 points; sham 1.2 ± 3.3; repeated measure analysis ANOVA Time X Group interaction P = 0.001). The same trends were observed in the clinical subscales. Following treatment, MEP amplitudes at higher intensities (140, and 150%) increased more in the real treatment group than in the sham group. This is the first clinical trial study of bilateral hemispheric rTMS in patients with TDS and suggests that 20 Hz rTMS might be a feasible treatment option in patients unresponsive to ""first-line"" treatment.Clinical trial registration ClinicalTrials.gov Identifier: NCT03145311.",2019,"Following treatment, MEP amplitudes at higher intensities (140, and 150%) increased more in the real treatment group than in the sham group.","['patients with', 'Twenty-six patients', 'tardive syndromes']","['Repetitive transcranial magnetic stimulation', 'real or sham rTMS', 'therapeutic repetitive transcranial magnetic stimulation (rTMS', 'bilateral hemispheric rTMS', 'TDS', 'rTMS']","['AIMS score', 'Abnormal Involuntary Movement Scale (AIMS) and TMS measures of M1 excitability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0172161', 'cui_str': 'tyramine-deoxysorbitol'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0450978', 'cui_str': 'Abnormal Involuntary Movement Scale'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",26.0,0.14823,"Following treatment, MEP amplitudes at higher intensities (140, and 150%) increased more in the real treatment group than in the sham group.","[{'ForeName': 'Eman M', 'Initials': 'EM', 'LastName': 'Khedr', 'Affiliation': 'Department of Neuropsychiatry, Faculty of Medicine, Assiut University Hospital, Assiut University, Assuit, Egypt. emankhedr99@yahoo.com.'}, {'ForeName': 'Bastawy', 'Initials': 'B', 'LastName': 'Al Fawal', 'Affiliation': 'Department of Neuropsychiatry, Faculty of Medicine, Aswan University Hospital, Aswan University, Aswan, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdelwarith', 'Affiliation': 'Department of Neuropsychiatry, Faculty of Medicine, Aswan University Hospital, Aswan University, Aswan, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Saber', 'Affiliation': 'Department of Neuropsychiatry, Faculty of Medicine, Aswan University Hospital, Aswan University, Aswan, Egypt.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-018-1941-x'] 3383,31388637,"Feasibility study for a randomized clinical trial of bupivacaine, lidocaine with adrenaline, or placebo wound infiltration to reduce postoperative pain after laparoscopic cholecystectomy.","Background Short-term pain relief can be achieved by local anaesthetic infiltration of port sites at the end of laparoscopic surgery. This study aimed to assess feasibility of performing an RCT to evaluate short-term postoperative analgesia after laparoscopic surgery in Nigeria using two local anaesthetics for port-site infiltration versus saline placebo. Methods This was a placebo-controlled, patient- and outcome assessor-blinded, external feasibility RCT. Patients undergoing elective laparoscopic cholecystectomy for symptomatic ultrasound-proven gallstones were randomized into three groups: lidocaine with adrenaline (epinephrine), bupivacaine or saline control. The feasibility of recruitment, compliance with randomized treatment allocation, and completion of pain and nausea outcome measures were evaluated. Pain was assessed at 2, 6, 12 and 24 h after surgery using a 0-10-point numerical rating scale (NRS) and a four-point verbal rating scale. Nausea was assessed using NRS at the same time points. Clinical outcomes were assessed only in patients who received the correct randomized treatment allocation. Results Of 79 patients screened for eligibility, 69 were consented and randomized (23 per group). Overall, compliance with randomized treatment allocation was achieved in 64 patients (93 per cent). All pain and nausea assessments were completed in these 64 patients. On the NRS, most patients had moderate to severe pain at 2 h (39 of 64, 61 per cent), which gradually reduced. Only six patients (9 per cent) had moderate to severe pain at 24 h. Conclusion Recruitment, compliance with the randomized allocation, and completion of pain outcome measures were satisfactory. This study demonstrates the feasibility of conducting a surgical RCT in a resource-limited setting. Registration number: ISRCTN 17667918 (https://www.isrctn.com).",2019,"Only six patients (9 per cent) had moderate to severe pain at 24 h. Conclusion Recruitment, compliance with the randomized allocation, and completion of pain outcome measures were satisfactory.","['64 patients (93 per cent', 'Patients undergoing elective laparoscopic cholecystectomy for symptomatic ultrasound-proven gallstones', '79 patients screened for eligibility, 69 were consented and randomized (23 per group', 'after laparoscopic cholecystectomy']","['RCT', 'bupivacaine, lidocaine with adrenaline, or placebo wound infiltration', 'lidocaine with adrenaline (epinephrine), bupivacaine or saline control', 'surgical RCT', 'saline placebo']","['postoperative pain', 'moderate to severe pain', 'severe pain', 'Nausea', 'Pain', 'All pain and nausea assessments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",69.0,0.560131,"Only six patients (9 per cent) had moderate to severe pain at 24 h. Conclusion Recruitment, compliance with the randomized allocation, and completion of pain outcome measures were satisfactory.","[{'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Adenekan', 'Affiliation': 'Department of Anaesthesia and Intensive Care Obafemi Awolowo University Ile-Ife Nigeria.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Aderounmu', 'Affiliation': 'Department of Surgery Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife Nigeria.'}, {'ForeName': 'F O', 'Initials': 'FO', 'LastName': 'Wuraola', 'Affiliation': 'Department of Surgery Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife Nigeria.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Owojuyigbe', 'Affiliation': 'Department of Anaesthesia and Intensive Care Obafemi Awolowo University Ile-Ife Nigeria.'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Adetoye', 'Affiliation': 'Department of Anaesthesia and Intensive Care Obafemi Awolowo University Ile-Ife Nigeria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nepogodiev', 'Affiliation': 'National Institute for Health Research Global Health Research Unit on Global Surgery University of Birmingham Birmingham UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Magill', 'Affiliation': 'National Institute for Health Research Global Health Research Unit on Global Surgery University of Birmingham Birmingham UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhangu', 'Affiliation': 'National Institute for Health Research Global Health Research Unit on Global Surgery University of Birmingham Birmingham UK.'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Adisa', 'Affiliation': 'Department of Surgery Obafemi Awolowo University Ile-Ife Nigeria.'}]",BJS open,['10.1002/bjs5.50159'] 3384,31388638,Randomized clinical trial of prophylactic transanal irrigation versus supportive therapy to prevent symptoms of low anterior resection syndrome after rectal resection.,"Background Low anterior resection syndrome (LARS) is a frequent problem after rectal resection. Transanal irrigation (TAI) has been suggested as an effective treatment in patients who have developed LARS. This prospective RCT was undertaken to evaluate the effect of TAI as a prophylactic treatment to prevent symptoms of LARS. Methods Patients who had undergone ultralow rectal resection were randomized to start TAI on a daily basis, or to serve as a control with supportive therapy only after ileostomy closure. All patients were seen after 1 week, 1 month and 3 months, and the maximum number of defaecation episodes per day and night documented during follow-up. Wexner score, LARS score and Short Form 36 questionnaire responses were evaluated in both groups. Results Thirty-seven patients could be evaluated according to protocol (TAI 18, control 19). The maximum number of stool episodes per day and per night was significantly lower among patients who underwent TAI at 1 month (median 3 versus 7 episodes/day in TAI versus control group, P  = 0·003; 0 versus 3 episodes/night, P  = 0·001) and 3 months (3 versus 5 episodes per day, P  = 0·006; 0 versus 1 episodes/night, P  = 0·002). LARS scores were significantly better in the TAI group after 1 month (median 16 versus 32 in control group; P  = 0·044) and 3 months (9 versus 31; P  = 0·001). A significantly better result in terms of Wexner score was seen in the TAI group after 3 months (median 2 versus 6 in controls; P  = 0·046). Conclusion Prophylactic TAI led to a significantly better functional outcome compared with supportive therapy for up to 3 months. Registration number: DRKS00011752 ( http://apps.who.int/trialsearch/).",2019,LARS scores were significantly better in the TAI group after 1 month (median 16 versus 32 in control group; P  = 0·044) and 3 months (9 versus 31; P  = 0·001).,"['patients who have developed LARS', 'Methods\n\n\nPatients who had undergone ultralow rectal resection', 'low anterior resection syndrome after rectal resection', 'Thirty-seven patients could be evaluated according to protocol (TAI 18, control 19']","['prophylactic transanal irrigation versus supportive therapy', '\n\n\nLow anterior resection syndrome (LARS', 'Transanal irrigation (TAI', 'start TAI', 'Prophylactic TAI', 'TAI']","['Wexner score', 'Wexner score, LARS score and Short Form 36 questionnaire responses', 'functional outcome', 'LARS scores', 'maximum number of stool episodes per day and per night']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach (qualifier value)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}]",37.0,0.0595676,LARS scores were significantly better in the TAI group after 1 month (median 16 versus 32 in control group; P  = 0·044) and 3 months (9 versus 31; P  = 0·001).,"[{'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Rosen', 'Affiliation': 'Faculty of Surgical Oncology, Sigmund Freud University Vienna Austria.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kneist', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Johannes Gutenberg University Mainz Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fürst', 'Affiliation': 'Department of Surgery, Caritas-Hospital St Josef Regensburg Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Krämer', 'Affiliation': 'Department of Surgery, Caritas-Hospital St Josef Regensburg Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hebenstreit', 'Affiliation': 'Department of Surgery, Hospital St John of God Graz Austria.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Schiemer', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Johannes Gutenberg University Mainz Germany.'}]",BJS open,['10.1002/bjs5.50160'] 3385,31453902,"Pain and Bruising Levels After Lip Augmentation: A Comparison of Anterograde and Retrograde Techniques Using an Automated Motorized Injection Device. A Blinded, Prospective, Randomized, Parallel Within-Subject Trial.","BACKGROUND Dermal fillers for lip augmentation can be injected using various techniques. Although all seem to provide acceptable results, it is not clear which technique is safer, less painful, and provides greater patient comfort. OBJECTIVE To compare patients' self-reported pain intensity during the injection of hyaluronic acid dermal filler for lip augmentation, with 2 different techniques, anterograde versus retrograde. METHODS AND MATERIALS Prospective, single-center, within-subject, single-blinded, randomized controlled trial. All subjects received injections in the lip with hyaluronic acid-based filler, each side using the anterograde or retrograde injection technique. An automated motorized injection device was used to ensure a homogeneous deposition flow of the product injected and reduce operator bias. Pain intensity was self-assessed using a 100-mm visual analog scale. Presence and severity of bruising were recorded. RESULTS Forty-four women (mean age 30.3 years) were randomized. Mean self-reported pain score was 53.1% lower with the anterograde technique than with the retrograde (p < .0001). The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique. CONCLUSION This study demonstrated that the anterograde technique was less painful, and led to fewer bruising and site reactions than the retrograde technique when using an automated device. LEVEL OF EVIDENCE I.",2020,"The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique. ",['Forty-four women (mean age 30.3 years'],"['Anterograde and Retrograde Techniques Using an Automated Motorized Injection Device', 'hyaluronic acid dermal filler for lip augmentation, with 2 different techniques, anterograde versus retrograde', 'lip with hyaluronic acid-based filler, each side using the anterograde or retrograde injection technique']","['pain intensity', 'rates of site reactions', 'Presence and severity of bruising', 'bruising and site reactions', 'Mean self-reported pain score', 'Pain intensity', 'Pain and Bruising Levels']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0589502', 'cui_str': 'Antegrade direction (qualifier value)'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0794888', 'cui_str': 'Injection device (physical object)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C4042850', 'cui_str': 'Skin Fillers'}, {'cui': 'C4523976', 'cui_str': 'Lip augmentation'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009938', 'cui_str': 'Bruise'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",44.0,0.207937,"The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique. ","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Galadari', 'Affiliation': 'College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Mariwalla', 'Affiliation': 'Mariwalla Dermatology, West Islip, New York.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Delobel', 'Affiliation': 'Teoxane Laboratories, Paris, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sanchez-Vizcaino Mengual', 'Affiliation': 'i2e3 Biomedical Research Institute, Barcelona, Spain.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002055'] 3386,31138577,Randomized Noninferiority Trial of Cefoperazone-Sulbactam versus Cefepime in the Treatment of Hospital-Acquired and Healthcare-Associated Pneumonia.,"Cefoperazone, a third-generation cephamycin with broad-spectrum antibacterial activity and the ability to permeate bacterial cell membranes, is active against commonly encountered multidrug-resistant pathogens for hospital-acquired pneumonia (HAP) and health care-associated pneumonia (HCAP). To clarify the clinical effects of cefoperazone-sulbactam in the treatment of HAP and HCAP, we conducted an open-label, randomized, noninferiority trial that recruited patients aged ≥18 years suffering HAP/HCAP. Participants were randomly assigned to the cefoperazone-sulbactam (2 g of each per 12 h) or cefepime (2 g per 12 h) arm. Clinical and microbiological responses were evaluated at early posttherapy and test-of-cure visits. Recruited patients were allocated to subpopulations for intent-to-treat ( n  = 154), per-protocol ( n  = 147), and safety ( n  = 166) analyses. Intent-to-treat analysis demonstrated that (i) at the early posttherapy visit, 87.3% of patients receiving cefoperazone-sulbactam and 84.3% of patients receiving cefepime achieved clinical improvement or cure (risk difference of 3.0%; 95% confidence interval [CI], -9.0% to 15.0%), and (ii) at the test-of-cure visit, 73.1% of patients receiving cefoperazone-sulbactam and 56.8% of patients receiving cefepime were assessed as cured (risk difference of 16.3%; 95% CI, 0.0% to 33.0%). These results indicated the noninferiority of cefoperazone-sulbactam to cefepime, which was confirmed by per-protocol analysis. The chest radiographic consolidation/infiltration resolution rate, microbiological eradiation rate, and percentage of adverse events were comparable in both groups. Serious adverse events were rare, and none was judged to be related to the study drugs. Cefoperazone-sulbactam at 2 g every 12 h was noninferior to cefepime at 2 g every 2 h for patients with HCAP.",2019,"The chest radiographic consolidation/infiltration resolution rate, microbiological eradiation rate, and percentage of adverse events were comparable in both groups.","['recruited patients aged ≥18 years suffering HAP/HCAP', 'Hospital-Acquired Pneumonia/Healthcare-Associated Pneumonia']","['cefoperazone', 'Cefoperazone', 'cefoperazone/sulbactam', 'Cefoperazone/sulbactam', 'Cefoperazone/Sulbactam versus Cefepime']","['Clinical and microbiological responses', 'chest radiographic consolidation/infiltration resolution rate, microbiological eradiation rate, and percentage of adverse events', 'clinical improvement or cure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0007552', 'cui_str': 'Cefoperazone'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0055003', 'cui_str': 'cefepime'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",166.0,0.23113,"The chest radiographic consolidation/infiltration resolution rate, microbiological eradiation rate, and percentage of adverse events were comparable in both groups.","[{'ForeName': 'Jien-Wei', 'Initials': 'JW', 'LastName': 'Liu', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yen-Hsu', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Sen', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Wan Fang Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Jung-Chung', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Ching-Tai', 'Initials': 'CT', 'LastName': 'Huang', 'Affiliation': 'Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Hsi-Hsun', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yung-Ching', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yin-Ching', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Internal Medicine, Chi Mei Hospital, Tainan, Taiwan.'}, {'ForeName': 'Hung-Jen', 'Initials': 'HJ', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, Chi Mei Medical Center, Tainan, Taiwan.'}, {'ForeName': 'Yao-Shen', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Chien', 'Initials': 'WC', 'LastName': 'Ko', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Min-Chi', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Fu-Der', 'Initials': 'FD', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan fdwang@vghtpe.gov.tw.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00023-19'] 3387,31013182,Randomized Phase II Trial to Compare the Efficacy of Haloperidol and Olanzapine in the Control of Chemotherapy-Induced Nausea and Vomiting in Nepal.,"PURPOSE The purpose of the study was to compare efficacy and toxicity of olanzapine (OLN; a higher-cost drug) and haloperidol (HAL; a lower-cost drug) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients who receive highly emetogenic chemotherapy (HEC). PATIENTS AND METHODS In a randomized, phase II trial, patients were randomly assigned to receive either OLN 10 mg orally on days 1 to 4 or HAL 1 mg orally on day 1 and 0.5 mg twice daily on days 2 to 4. Both groups received ondansetron 16 mg and dexamethasone 12 mg intravenously on day 1. Patients recorded their nausea using the Edmonton Symptom Assessment Scale (ESAS) and recorded daily episodes of vomiting from day 1 to day 5. The primary end point was complete nausea prevention (CNP; ie, ESAS of 0). Secondary end point was complete emesis prevention (CEP). RESULTS Sixty-five patients were randomly assigned, and 64 received their allocated treatment (n = 32 in each arm). There was no difference in CNP during the overall period (days 1 to 5) between OLN and HAL (68.7% v 71.8%; P = .78). In the acute period (day 1) and the delayed period (days 2 to 5), CNP was similar between OLN and HAL (acute: 84.3% v 81.2%; delayed: 68.7% v 75%). No difference was identified in the rate of CEP during the overall period (81.2% with OLN v 78.1% with HAL; P = .75), during the acute period (93.7% with OLN v 90.6% with HAL), or during the delayed period (84.3% with OLN v 84.3% with HAL). No difference in toxicities was noted between treatment arms. CONCLUSION In this study, HAL had comparable efficacy to OLN in the management of CINV, which suggests that it is the higher-value option in patients who receive HEC in resource-scarce countries.",2019,"In the acute period (day 1) and the delayed period (days 2 to 5), CNP was similar between OLN and HAL (acute: 84.3% v 81.2%; delayed: 68.7% v 75%).","['Sixty-five patients', 'patients who receive HEC in resource-scarce countries', 'Nepal', 'patients who receive highly emetogenic chemotherapy (HEC']","['OLN 10 mg orally on days 1 to 4 or HAL', 'olanzapine (OLN', 'HAL', 'Haloperidol and Olanzapine', 'ondansetron 16 mg and dexamethasone', 'OLN', 'haloperidol (HAL']","['complete nausea prevention (CNP; ie, ESAS of 0', 'Nausea and Vomiting', 'nausea and vomiting (CINV', 'nausea using the Edmonton Symptom Assessment Scale (ESAS) and recorded daily episodes of vomiting', 'CNP', 'efficacy and toxicity', 'toxicities', 'complete emesis prevention (CEP', 'rate of CEP']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1134857', 'cui_str': 'Ondansetron 16 MG'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",65.0,0.0485401,"In the acute period (day 1) and the delayed period (days 2 to 5), CNP was similar between OLN and HAL (acute: 84.3% v 81.2%; delayed: 68.7% v 75%).","[{'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Dulal', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Bishnu Dutta', 'Initials': 'BD', 'LastName': 'Paudel', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'The University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Aarati', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Bibek', 'Initials': 'B', 'LastName': 'Acharya', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Bishesh Sharma', 'Initials': 'BS', 'LastName': 'Poudyal', 'Affiliation': 'Civil Service Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Ramila', 'Initials': 'R', 'LastName': 'Shilpakar', 'Affiliation': 'National Academy of Medical Sciences, Bir Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Lori Anne', 'Initials': 'LA', 'LastName': 'Wood', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.'}]",Journal of global oncology,['10.1200/JGO.18.00245'] 3388,30666367,Nasal high-flow preoxygenation for endotracheal intubation in the critically ill patient: a randomized clinical trial.,"PURPOSE Preoxygenation with high-flow therapy by nasal cannulae (HFNC) is now widespread in the intensive care unit (ICU). However, no large randomized study has assessed its relevance in non-severely hypoxemic patients. In a randomized controlled trial (PROTRACH study), we aimed to evaluate preoxygenation with HFNC vs. standard bag-valve mask oxygenation (SMO) in non-severely hypoxemic patients during rapid sequence intubation (RSI) in the ICU. METHODS Randomized controlled trial including non-severely hypoxemic patients requiring intubation in the ICU. Patients received preoxygenation by HFNC or SMO during RSI. HFNC was maintained throughout the intubation procedure whereas SMO was removed to perform laryngoscopy. The primary outcome was the lowest pulse oximetry (SpO 2 ) throughout the intubation procedure. Secondary outcomes included drop in SpO 2 , adverse events related to intubation, and outcome in the ICU. RESULTS A total of 192 patients were randomized. In the intent-to-treat analysis, 184 patients (HFNC n = 95; SMO n = 89), the median [IQR] lowest SpO 2 was 100% [97; 100] for HFNC and 99% [95; 100] for the SMO group (P = 0.30). Mild desaturation below 95% was more frequent with SMO (23%) than with HFNC (12%) (RR 0.51, 95% CI 0.26-0.99, P = 0.045). There were fewer adverse events in the HFNC group (6%) than in the SMO group (19%) (RR 0.31, 95% CI 0.13-0.76, P = 0.007), including fewer severe adverse events, respectively 6 (6%) and 14 (16%) with HFNC and SMO (RR 0.38, 95% CI 0.15-0.95, P = 0.03). CONCLUSIONS Compared with SMO, preoxygenation with HFNC in the ICU did not improve the lowest SpO 2 during intubation in the non-severely hypoxemic patients but led to a reduction in intubation-related adverse events. TRIAL REGISTRATION Clinical trial Submission: 7 March 2016. Registry name: Benefits of high-flow nasal cannulae oxygen for preoxygenation during intubation in non-severely hypoxemic patients: the PROTRACH study. Clinicaltrials.gov identifier: NCT02700321. Eudra CT: 2015-A00145-44. CPP: 15/13-975 (Comité de protection des personnes de Rennes). URL registry: https://clinicaltrials.gov/ct2/show/record/NCT02700321 .",2019,"There were fewer adverse events in the HFNC group (6%) than in the SMO group (19%) (RR 0.31, 95% CI 0.13-0.76, P = 0.007), including fewer severe adverse events, respectively 6 (6%) and 14 (16%) with HFNC and SMO (RR 0.38, 95% CI 0.15-0.95, P = 0.03). ","['non-severely hypoxemic patients during rapid sequence intubation (RSI) in the ICU', 'non-severely hypoxemic patients requiring intubation in the ICU', '192 patients were randomized', 'critically ill patient', 'non-severely hypoxemic patients']","['SMO', 'preoxygenation by HFNC or SMO', 'HFNC', 'HFNC vs. standard bag-valve mask oxygenation (SMO', 'high-flow nasal', 'CPP', 'Nasal high-flow preoxygenation']","['lowest pulse oximetry (SpO 2 ', 'Mild desaturation', 'adverse events', 'drop in SpO 2 , adverse events related to intubation, and outcome in the ICU', 'severe adverse events']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0412792', 'cui_str': 'Preoxygenation (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0047123', 'cui_str': 'CPP'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",192.0,0.4984,"There were fewer adverse events in the HFNC group (6%) than in the SMO group (19%) (RR 0.31, 95% CI 0.13-0.76, P = 0.007), including fewer severe adverse events, respectively 6 (6%) and 14 (16%) with HFNC and SMO (RR 0.38, 95% CI 0.15-0.95, P = 0.03). ","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Guitton', 'Affiliation': 'Service de Réanimation Médico Chirurgicale, USC, Centre Hospitalier du Mans, 194 Avenue Rubillard, 72037, Le Mans Cedex 9, France. cguitton@ch-lemans.fr.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Médecine Intensive Réanimation, INSERM CIC 1415, Centre Hospitalier Universitaire de Tours, Centre d'Etude des Pathologies Respiratoires INSERM U1100, Tours University, Tours, France.""}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Gwenhael', 'Initials': 'G', 'LastName': 'Colin', 'Affiliation': 'Médecine Intensive Réanimation, Centre Hospitalier de La Roche sur Yon, La Roche-Sur-Yon, France.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Maamar', 'Affiliation': 'Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Rennes, Rennes, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Jean-Michel', 'Affiliation': 'Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Brest, Brest, France.'}, {'ForeName': 'Pierre-Joachim', 'Initials': 'PJ', 'LastName': 'Mahe', 'Affiliation': ""Service d'Anesthésie-Réanimation Chirurgicale, Hôtel-Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France.""}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Landais', 'Affiliation': 'Service de Réanimation Médico Chirurgicale, USC, Centre Hospitalier du Mans, 194 Avenue Rubillard, 72037, Le Mans Cedex 9, France.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Brule', 'Affiliation': 'Médecine Intensive Réanimation, Hôtel-Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bretonnière', 'Affiliation': 'Médecine Intensive Réanimation, Hôtel-Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Zambon', 'Affiliation': 'Médecine Intensive Réanimation, Hôtel-Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': ""Vourc'h"", 'Affiliation': 'Médecine Intensive Réanimation, Hôtel-Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}]",Intensive care medicine,['10.1007/s00134-019-05529-w'] 3389,30544179,Using a holistic health approach to achieve weight-loss maintenance: results from the Spirited Life intervention.,"Weight-loss maintenance is essential to sustain the health benefits of weight loss. Studies with lower intensity intervention supports under real-world conditions are lacking. This study examined changes in weight and cardiometabolic biomarkers among Spirited Life participants following initial 12-month weight loss at 12-24 months and 24-42 months. A total of 719 clergy received a wellness intervention, including a 10-week online weight-loss program in the first 12 months and monthly health coaching throughout 24 months. Mean changes in weight, blood pressure, high-density lipoproteins, and triglycerides were estimated using random effects linear models, accounting for repeated measures. Weight was additionally analyzed in subsamples stratified by body mass index (BMI). At baseline, 17.1% of participants had BMI < 25 kg/m2 and 11.8% had BMI ≥ 40 kg/m2. Mean 12-month weight loss was -2.4 kg (95% CI: -2.8 kg, -2.1 kg). On average, at 42 months, participants regained weight but did not exceed baseline (-0.5 kg, 95% CI: -1.2 kg, 0.2 kg), improvements in triglycerides were completely sustained (-13.9 mg/dL, 95% CI: -18.6 mg/dL, -9.2 mg/dL), and systolic blood pressure improvements remained significant (-1.9 mmHg, 95% CI: -3.0 mmHg, -0.9 mmHg). Participants with a BMI ≥ 40 kg/m2 lost significantly more weight that was sustained at 42 months (-5.8 kg, 95% CI: -8.9 kg, -2.7 kg). The Spirited Life wellness intervention produced weight loss and, for participants with higher levels of obesity, sustained weight-loss maintenance. The intervention was effective for long-term prevention of weight gain among participants with BMI of 25 to ≤40 kg/m2, through 42 months. Wellness interventions such as Spirited Life should be considered for adoption.",2020,The intervention was effective for long-term prevention of weight gain among participants with BMI of 25,"['A total of 719 clergy received a', 'participants with BMI of 25', 'Spirited Life participants following initial 12-month weight loss at 12-24 months and 24-42 months']","['wellness intervention, including a 10-week online weight-loss program in the first 12 months and monthly health coaching throughout 24 months', 'holistic health approach']","['Mean 12-month weight loss', 'Mean changes in weight, blood pressure, high-density lipoproteins, and triglycerides', 'improvements in triglycerides', 'weight loss', 'weight-loss maintenance', 'obesity, sustained weight-loss maintenance', 'Weight', 'weight and cardiometabolic biomarkers', 'systolic blood pressure improvements', 'weight gain', 'weight']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008935', 'cui_str': 'Clergy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0019844', 'cui_str': 'Wholistic Health Care'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",719.0,0.0427098,The intervention was effective for long-term prevention of weight gain among participants with BMI of 25,"[{'ForeName': 'Rae Jean', 'Initials': 'RJ', 'LastName': 'Proeschold-Bell', 'Affiliation': 'Duke Global Health Institute, Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Dori M', 'Initials': 'DM', 'LastName': 'Steinberg', 'Affiliation': 'Duke School of Nursing, Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Eagle', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Grace Y', 'Initials': 'GY', 'LastName': 'Cai', 'Affiliation': 'Trinity College of Arts & Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby117'] 3390,30588849,Impact of an Individually Tailored Light Mask on Sleep Parameters in Older Adults With Advanced Phase Sleep Disorder.,"Objective : This study investigated whether light delivered through the eyelids of sleeping persons might create phase delay in older adults who are adversely affected by advanced sleep phase disorder. Participants : Thirty-two cognitively intact, community-dwelling participants aged ≥ 50 years (20 females, 12 males) with Pittsburgh Sleep Quality Index scores ≥ 5 (poor sleep) completed the study. Methods : This within-subjects, randomized, two-treatment crossover design study exposed participants to an active ""blue"" (λ max   =  480 nm) lighting intervention or a placebo ""red"" (λ max  = 640 nm) control through closed eyelids during sleep for 8 weeks. Conditions were administered 1 hr after bedtime using custom-built light masks delivering a train of 2-s duration light pulses presented every 30 s for ≤ 2 hr (approximately 240 pulses/night). Dependent variables were subjective measures of sleep and depression (questionnaires) and objective measures of sleep (wrist actigraphy), analyzed using linear mixed models with treatment, period, and carryover as fixed effects. Results : The actigraphy analysis found no effect of the intervention or the control condition on sleep start time, total sleep time, number of sleep bouts, or sleep efficiency, either compared to baseline or to one another. Subjective responses of study participants, however, indicated statistically significant ( p < 0.05) improvement in seven of eight reported measures of sleep quality with both the intervention and the control condition, but no difference between the two conditions. Conclusions : The participants reported improvement in sleep quality, but the intervention did not confer additional advantages after adjusting for period and carryover effects.",2020,"The participants reported improvement in sleep quality, but the intervention did not confer additional advantages after adjusting for period and carryover effects.","['Older Adults With Advanced Phase Sleep Disorder', 'Thirty-two cognitively intact, community-dwelling participants aged ≥ 50\xa0years (20 females, 12 males) with Pittsburgh Sleep Quality Index scores ≥ 5 (poor sleep) completed the study', 'older adults who are adversely affected by advanced sleep phase disorder']","['480\xa0nm) lighting intervention or a placebo ""red"" (λ max \xa0', 'Individually Tailored Light Mask', 'active ""blue"" (λ max \u2009\xa0']","['sleep start time, total sleep time, number of sleep bouts, or sleep efficiency', 'Sleep Parameters', 'subjective measures of sleep and depression (questionnaires) and objective measures of sleep (wrist actigraphy), analyzed using linear mixed models with treatment, period, and carryover as fixed effects', 'sleep quality']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4545801', 'cui_str': 'PSQI (Pittsburgh Sleep Quality Index) score'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0854739', 'cui_str': 'Advanced sleep phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}]","[{'cui': 'C0456512', 'cui_str': 'Sleep Starts'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0498453,"The participants reported improvement in sleep quality, but the intervention did not confer additional advantages after adjusting for period and carryover effects.","[{'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Lighting Research Center, School of Architecture, Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reed', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Preisser', 'Affiliation': 'Department of Biostatistics at the Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Opthalmology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2018.1557189'] 3391,32067262,"First-in-human study with ACT-539313, a novel selective orexin-1 receptor antagonist.","AIMS The orexin system is involved in anxiety behaviour and corresponding physiological reactions and constitutes a target for treatment of anxiety disorders. ACT-539313 is a potent, selective orexin-1 receptor antagonist being developed for the treatment of anxiety disorders. This first-in-human study investigated its single-dose pharmacokinetics (PK) including food effect, pharmacodynamics (PD), safety and tolerability. METHODS This double-blind, placebo-controlled, randomized study included 40 healthy male subjects. Ascending oral doses of 10-400 mg ACT-539313 were investigated in 5 dose groups of 8 subjects (of whom 2 received placebo per dose group). At 100 mg, subjects received ACT-539313 in fasted and fed conditions in a fixed sequential design. PK, PD (objective and subjective measures of sedation and effects on central nervous system), safety and tolerability were assessed. RESULTS In fasted conditions, ACT-539313 was rapidly absorbed (median time to maximum plasma concentration [C max ] 0.7-3.5 h) and cleared from plasma with a mean terminal half-life of 3.3-5.7 h across dose levels. A 1.63-fold (90% confidence interval: 1.26-2.11) increase in C max and no change in area under the concentration-time curve extrapolated to infinity was observed under fed compared to fasted conditions. No relevant PD signals were detected except for a trend of reduced saccadic peak velocity around time to C max . The most commonly reported adverse events were somnolence and headache. All adverse events were transient and of mild or moderate intensity. No treatment-related effects on vital signs, clinical laboratory or 12-lead electrocardiogram were observed. CONCLUSIONS ACT-539313 exhibits good safety and tolerability at single doses of up to and including 400 mg that warrant further investigations.",2020,"No treatment-related effects on vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG) were observed. ",['40 healthy male subjects'],"['placebo', 'ACT-539313']","['food effect, pharmacodynamics (PD), safety, and tolerability', 'somnolence and headache', 'vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG', 'saccadic peak velocity', 'C max and no change in AUC 0-inf', 'safety and tolerability', 'PK, PD (objective and subjective measures of sedation and effects on central nervous system), safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0518766'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]",40.0,0.258047,"No treatment-related effects on vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG) were observed. ","[{'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ort', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Kornberger', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14251'] 3392,31358046,Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF).,"BACKGROUND The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing ""minor"" amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care. METHODS In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain. RESULTS At 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p = 0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. CONCLUSION The results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded. TRIAL REGISTRATION ClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).",2019,"The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. ","['114 patients undergoing a lower limb minor amputation', 'diabetic foot minor amputations']","['standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®', 'Autologous micro-fragmented adipose tissue', 'autologous micro-fragmented adipose tissue']","['pain scale', 'healing rate', 'healing rate and time after the minor amputation', 'adipose tissue-treated feet healed', 'skin tropism', 'technical success', 'assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0242732', 'cui_str': 'Tropism'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",114.0,0.0859011,"The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. ","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lonardi', 'Affiliation': 'Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Via Giardini, 1355, 41126, Baggiovara, MO, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Leone', 'Affiliation': 'Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Via Giardini, 1355, 41126, Baggiovara, MO, Italy. nicola.leone.md@gmail.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gennai', 'Affiliation': 'Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Via Giardini, 1355, 41126, Baggiovara, MO, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Trevisi Borsari', 'Affiliation': 'Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Via Giardini, 1355, 41126, Baggiovara, MO, Italy.'}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Covic', 'Affiliation': 'Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Via Giardini, 1355, 41126, Baggiovara, MO, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Silingardi', 'Affiliation': 'Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Via Giardini, 1355, 41126, Baggiovara, MO, Italy.'}]",Stem cell research & therapy,['10.1186/s13287-019-1328-4'] 3393,31113476,"Treatment of knee osteoarthritis with intra-articular injection of autologous adipose-derived mesenchymal progenitor cells: a prospective, randomized, double-blind, active-controlled, phase IIb clinical trial.","OBJECTIVE Human adipose-derived mesenchymal progenitor cells (haMPCs) are stem cells with multiple differentiation potential and immunomodulatory function. Re-Join® comprises in vitro expanded haMPCs from adipose tissue of patients combined with cell suspension solution. This study was undertaken to evaluate the efficacy and safety of Re-Join® in patients with symptomatic knee osteoarthritis (OA). METHODS Patients with Kellgren-Lawrence grade 1-3 knee OA were recruited from two centers and randomized to receive intra-articular injection of Re-Join® or HA. Pain and function were assessed by using WOMAC score, VAS, and SF-36. Magnetic resonance imaging (MRI) analysis was performed to measure cartilage repair. Adverse events (AEs) were collected. RESULTS Fifty-three patients were randomized. Significant improvements in WOMAC, VAS, and SF-36 scores were observed in both groups at months 6 and 12 compared with baseline. Compared with the HA group, significantly more patients achieved 50% improvement of WOMAC and a trend of more patients achieved a 70% improvement rate in Re-Join® group after 12 months. Meanwhile, there was notably more increase in articular cartilage volume of both knees in the Re-Join® group than in the HA group after 12 months as measured by MRI. AEs were comparable between two groups. Most AEs were mild and moderate except one SAE of right knee joint infection in the HA group. CONCLUSIONS Significant improvements in joint function, pain, quality of life, and cartilage regeneration were observed in Re-Join®-treated knee OA patients with good tolerance in a period of 12 months. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02162693 . Registered 13 June 2014.",2019,"Significant improvements in WOMAC, VAS, and SF-36 scores were observed in both groups at months 6 and 12 compared with baseline.","['patients with symptomatic knee osteoarthritis (OA', 'Fifty-three patients were randomized', 'Patients with Kellgren-Lawrence grade 1-3 knee OA']","['Human adipose-derived mesenchymal progenitor cells (haMPCs', 'autologous adipose-derived mesenchymal progenitor cells', 'intra-articular injection of Re-Join® or HA', 'Magnetic resonance imaging (MRI', 'Re-Join®']","['SAE of right knee joint infection', 'WOMAC, VAS, and SF-36 scores', 'Pain and function', 'WOMAC', 'articular cartilage volume', 'efficacy and safety', 'joint function, pain, quality of life, and cartilage regeneration', 'WOMAC score, VAS, and SF-36', 'Adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4552764', 'cui_str': 'Mesenchymal Progenitor Cell'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C4281598', 'cui_str': 'Right knee'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007303', 'cui_str': 'Cartilage, Articular'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0034380'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",53.0,0.129653,"Significant improvements in WOMAC, VAS, and SF-36 scores were observed in both groups at months 6 and 12 compared with baseline.","[{'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai, 200001, People's Republic of China.""}, {'ForeName': 'Chengxiang', 'Initials': 'C', 'LastName': 'Dai', 'Affiliation': 'Cellular Biomedicine Group, Shanghai, China.'}, {'ForeName': 'Zhongwen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, The General Hospital of Chinese People's Armed Police Forces, Beijing, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ""Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai, 200001, People's Republic of China.""}, {'ForeName': 'Suke', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Cellular Biomedicine Group, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': ""Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai, 200001, People's Republic of China.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ""Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai, 200001, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Cellular Biomedicine Group, Shanghai, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Cellular Biomedicine Group, Shanghai, China.'}, {'ForeName': 'Yuru', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of MRI, The General Hospital of Chinese People's Armed Police Forces, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai, 200001, People's Republic of China.""}, {'ForeName': 'Dongbao', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Department of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Chunde', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': ""Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle of Shandong Road, Huangpu District, Shanghai, 200001, People's Republic of China. baochunde_1678@126.com.""}]",Stem cell research & therapy,['10.1186/s13287-019-1248-3'] 3394,30881606,Smartphone-Based Remote Self-Management of Chronic Low Back Pain: A Preliminary Study.,"Objective To assess the additional effect of self-management on physiotherapy via the use of APPS on management of chronic low back pain. Method A single-blinded randomized control trial was conducted. 8 participants (male: 4; female: 4) were recruited from the Rehabilitation Clinic of The Hong Kong Polytechnic University. Participants in the treatment group received self-management plus physiotherapy and the control group received physiotherapy only. Assessment was carried out pretreatment, midterm (week 2), and posttreatment (week 4), including Visual Analog Scale (VAS), Pain Self-Efficacy Questionnaire (PSEQ), Roland Morris Disability Questionnaire (RMDQ), and SF36. Results Compared with the physiotherapy group, the self-management plus physiotherapy group had significance in PSEQ ( p =0.035), RMDQ ( p =0.035), SF36-Bodily Pain ( p =0.008), and SF36-Mental Health ( p =0.013). VAS showed a positive trend although there was no significant difference. Conclusion This pilot study indicated that smartphone APPS-based self-management program appears to bring additional benefits to physiotherapy for patients with CLBP. Self-management is a potential approach for people with CLBP.",2019,This pilot study indicated that smartphone APPS-based self-management program appears to bring additional benefits to physiotherapy for patients with CLBP.,"['8 participants (male: 4; female: 4) were recruited from the Rehabilitation Clinic of The Hong Kong Polytechnic University', 'patients with CLBP', 'Chronic Low Back Pain', 'people with CLBP']","['self-management plus physiotherapy and the control group received physiotherapy only', 'Smartphone-Based Remote Self-Management', 'APPS', 'smartphone APPS-based self-management program', 'VAS']","['Visual Analog Scale (VAS), Pain Self-Efficacy Questionnaire (PSEQ), Roland Morris Disability Questionnaire (RMDQ), and SF36', 'PSEQ', 'SF36-Bodily Pain', 'RMDQ', 'SF36-Mental Health']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic (environment)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0557813', 'cui_str': 'Polytechnic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4075347', 'cui_str': 'PSEQ - Pain Self-efficacy Questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",8.0,0.0775072,This pilot study indicated that smartphone APPS-based self-management program appears to bring additional benefits to physiotherapy for patients with CLBP.,"[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'The Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yanlei', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'The Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lijiao', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'The Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Meidan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'College of Acupuncture and Massage, Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}]",Journal of healthcare engineering,['10.1155/2019/4632946'] 3395,30003521,Effect of Maternal Vitamin B12 Supplementation on Cognitive Outcomes in South Indian Children: A Randomized Controlled Clinical Trial.,"Objectives To examine the effects of oral maternal vitamin B12 supplementation during pregnancy and early lactation on cognitive development in children. Method We studied 218 children born to mothers enrolled in a placebo-controlled, randomized trial of vitamin B12 supplementation during pregnancy through 6 weeks post-partum. Cognitive functions were assessed at 30 months using the Bayley Scales of Infant Development- 3rd edition (BSID III). The association of maternal sociodemographic characteristics, maternal biochemical status during pregnancy, birth weight and home environment with each sub-domain of BSID-III was examined using linear regression analysis. Separate multiple linear regression analyses for each of the BSID-III sub-domains with maternal trimester specific nutritional biomarker status was conducted. Results Children of mothers who received oral vitamin B12 supplementation had significantly higher scores on expressive language compared to children of mothers who received placebo (β = 0.14, P = 0.03). Children of mothers with elevated serum total homocysteine (tHcy) in the second and third trimesters of pregnancy had significantly lower scores on expressive language (β = - 0.18, P = 0.03 and β = - 0.19, P = 0.02, respectively) and gross motor domains (β = - 0.23, P = 0.008 and β = - 0.30, P = 0.001, respectively) of BSID-III adjusted for treatment arm and multiple confounders, compared with children whose mothers did not have elevated tHcy. Conclusions for practice Maternal B12 supplementation during pregnancy was associated with higher expressive language scores in children at 30 months. Elevated maternal tHcy levels during pregnancy had negative associations with expressive language and gross motor domains of BSID-III. Larger trials of maternal B12 supplementation are needed to confirm these findings.",2019,"Results Children of mothers who received oral vitamin B12 supplementation had significantly higher scores on expressive language compared to children of mothers who received placebo (β = 0.14, P = 0.03).","['children', 'South Indian Children', '218 children born to mothers enrolled in a']","['placebo', 'Maternal Vitamin B12 Supplementation', 'oral vitamin B12 supplementation', 'vitamin B12 supplementation', 'oral maternal vitamin B12 supplementation']","['expressive language scores', 'Cognitive Outcomes', 'Elevated maternal tHcy levels', 'elevated serum total homocysteine (tHcy', 'Bayley Scales of Infant Development- 3rd edition (BSID III', 'expressive language', 'maternal sociodemographic characteristics, maternal biochemical status during pregnancy, birth weight and home environment with each sub-domain of BSID-III', 'Cognitive functions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1444752', 'cui_str': 'Status during (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",218.0,0.166602,"Results Children of mothers who received oral vitamin B12 supplementation had significantly higher scores on expressive language compared to children of mothers who received placebo (β = 0.14, P = 0.03).","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's National Academy of Health Sciences, St John's Research Institute, Bengaluru, Karnataka, 560034, India.""}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Division of Epidemiology, Biostatistics and Population Health, St John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Bosch', 'Affiliation': 'Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Ramthal', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's National Academy of Health Sciences, St John's Research Institute, Bengaluru, Karnataka, 560034, India.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bellinger', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""Division of Nutrition, St John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's National Academy of Health Sciences, St John's Research Institute, Bengaluru, Karnataka, 560034, India. srinivas@sjri.res.in.""}]",Maternal and child health journal,['10.1007/s10995-018-2605-z'] 3396,31855102,Responsiveness Evaluation and Recommendation for Responder Thresholds for Endometriosis Health Profile-30: Analysis of Two Phase III Clinical Trials.,"Objective: To evaluate the responsiveness of the Endometriosis Health Profile-30 (EHP-30) and ascertain score changes that are indicative of response to treatment. A post hoc analysis of two Phase III, double-blind, placebo-controlled, randomized clinical trials among women with moderate-to-severe endometriosis-associated pain (Elaris Endometriosis I and II [EM-I and EM-II]). Materials and Methods: EHP-30 core items and sexual relationship module were administered at day 1, month 3 (M3), and month 6 (M6) to monitor patient-reported impacts of endometriosis-related pain. A seven-response level Patient Global Impression of Change (PGIC) was administered at M3 and M6. Dysmenorrhea (DYS), nonmenstrual pelvic pain (NMPP), and dyspareunia (DYSP) were collected using a daily diary. Three psychometric approaches, ""triangulation,"" were used to suggest responder thresholds for the EHP-30 domains. The three approaches were anchor- and distribution-based analyses and use of clinically relevant indicators (DYS, NMPP, DYSP). Results: EM-I and EM-II enrolled 871 and 815 women, respectively. All EHP-30 domains improved during the trials (M3, M6). Differences ( p  < 0.001) for all EHP-30 domains were found among the PGIC responses at M3 and M6, indicating greater change was associated with greater EHP-30 improvements. Large effect sizes were noted for all EHP-30 domains (EM-I range -0.59 to -1.80; EM-II range -0.52 to -1.59). EHP-30 thresholds of meaningful change ranged from -20 to -35, with greater changes indicating greater improvement in health status. Conclusion: Responder thresholds by EHP-30 domain are recommended to evaluate treatment efficacy. Clinicians can individualize goals of treatment by EHP-30 domain and track changes using the EHP-30.",2020,"Differences ( p  < 0.001) for all EHP-30 domains were found among the PGIC responses at M3 and M6, indicating greater change was associated with greater EHP-30 improvements.","['EM-I and EM-II enrolled 871 and 815 women, respectively', 'Endometriosis Health Profile-30', 'women with moderate-to-severe endometriosis-associated pain (Elaris Endometriosis I and II']",['placebo'],"['EHP-30 improvements', 'Dysmenorrhea (DYS), nonmenstrual pelvic pain (NMPP), and dyspareunia (DYSP', 'health status']","[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",815.0,0.102285,"Differences ( p  < 0.001) for all EHP-30 domains were found among the PGIC responses at M3 and M6, indicating greater change was associated with greater EHP-30 improvements.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Pokrzywinski', 'Affiliation': 'Evidera, Patient-Centered Research, Bethesda, Maryland.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Evidera, Patient-Centered Research, Bethesda, Maryland.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois.'}, {'ForeName': 'Huge S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Evidera, Patient-Centered Research, Bethesda, Maryland.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7788'] 3397,32062677,Impact of postoperative instructions on physical activity following pelvic reconstructive surgery: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS There is little information on the impact that postoperative instructions have on physical activity to help guide physicians in providing these recommendations after surgery. Our study objective was to evaluate the impact of postoperative instructions on physical activity. We hypothesized that there would be no differential effect of instructions on activity. METHODS In this randomized controlled trial, patients undergoing prolapse repair were randomized to receive either liberal or restricted postoperative activity instructions between February 2017 and February 2019. Physical activity was measured using the Activities Assessment Scale (AAS) and tri-axial accelerometers measured at baseline and 2 and 6 weeks after surgery. A sample size of 146 patients was planned to compare these activity measurements. AAS scores and accelerometer readings of the two groups were compared using separate variance t tests. RESULTS A total of 157 women were recruited between February 2017 and February 2019, including 146 patients with completed study data (n = 72 liberal, n = 74 restricted). There was no difference in physical activity at 2 weeks between the liberal and the restricted instruction groups, as measured by AAS scores (70.47 ± 12.83, 69.54 ± 12.22, p = 0.66), total steps (4,582.20 ± 2,164.5, 5,014.47 ± 3,025.46, p = 0.32), active minutes (4.22 ± 6.17, 4.96 ± 9.65, p = 0.25), and 10-min intervals (0.76 ± 1.11, 0.77 ± 0.93, p = 0.95) respectively. Similarly, there was no difference in activity at 6 weeks between the liberal and the restricted instruction groups. as measured by AAS scores (81.86 ± 8.25, 81.31 ± 10.31, p = 0.72), total steps (6,316.25 ± 3,173.53, 6,589.94 ± 3,826.43, p = 0.64), active minutes (8.79 ± 10.5,11.36 ± 18.18, p = 0.98), and 10-min intervals (1.37 ± 1.34, 1.34 ± 1.40, p = 0.89) respectively. CONCLUSION Postoperative instructions do not have an impact on physical activity measures in patients who have undergone pelvic reconstructive surgery.",2020,"There was no difference in physical activity at 2 weeks between the liberal and the restricted instruction groups, as measured by AAS scores (70.47 ± 12.83, 69.54 ± 12.22, p = 0.66), total steps (4,582.20 ± 2,164.5, 5,014.47 ± 3,025.46, p = 0.32), active minutes (4.22 ± 6.17, 4.96 ± 9.65, p = 0.25), and 10-min intervals (0.76 ± 1.11, 0.77 ± 0.93, p = 0.95) respectively.","['pelvic reconstructive surgery', '146 patients', 'patients undergoing prolapse repair', 'A total of 157 women were recruited between February 2017 and February 2019, including 146 patients with completed study data (n\xa0=\u200972 liberal, n\xa0=\u200974 restricted', 'patients who have undergone pelvic reconstructive surgery']","['liberal or restricted postoperative activity instructions', 'postoperative instructions']","['physical activity', 'total steps', 'activity', 'AAS scores and accelerometer readings', 'physical activity measures', 'Activities Assessment Scale (AAS) and tri-axial accelerometers', 'AAS scores', 'Physical activity']","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}]",157.0,0.286073,"There was no difference in physical activity at 2 weeks between the liberal and the restricted instruction groups, as measured by AAS scores (70.47 ± 12.83, 69.54 ± 12.22, p = 0.66), total steps (4,582.20 ± 2,164.5, 5,014.47 ± 3,025.46, p = 0.32), active minutes (4.22 ± 6.17, 4.96 ± 9.65, p = 0.25), and 10-min intervals (0.76 ± 1.11, 0.77 ± 0.93, p = 0.95) respectively.","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Arunachalam', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Indiana University, 11725 N. Illinois Street, Suite K140, Carmel, IN, 46032, USA. divya.arunachalam77@gmail.com.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Heit', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Indiana University, 11725 N. Illinois Street, Suite K140, Carmel, IN, 46032, USA.'}]",International urogynecology journal,['10.1007/s00192-020-04239-y'] 3398,32164634,Randomized trial evaluating the effectiveness of within versus across-category front-of-package lower-calorie labelling on food demand.,"BACKGROUND Several front-of-pack (FOP) labels identify healthier options by comparing foods within product categories. Alternative approaches label healthier options by comparing across categories. Which approach is superior remains unknown. The objective of this study was to test the effect of a within-category versus across-category FOP lower calorie label on 1) the percentage of labeled products purchased, 2) several measures of calories purchased (total, per dollar and per serving), and 3) total spending. We also tested the moderating effects of hunger and mood on purchasing patterns. METHODS Using an online grocery store, we conducted a 3 × 3 crossover trial involving actual purchases with 146 participants randomly exposed to: 1) no labeling control; 2) within-category lower calorie labels, and; 3) across-category lower calorie labels. We labeled the 20% of products with the lowest calories per serving within or across categories. Purchases were compared using a fixed effects regression on first-differenced outcomes. RESULTS Relative to the control condition, there was a 3 percentage point increase (p = 0.01) in labelled products purchased in the within-category arm and a non-significant decrease of 1 percentage point (p = 0.711) in the across-category arm. There was no significant difference in the proportion of labeled products purchased between the two labelling conditions. Neither strategy resulted in reductions in any measure of calories purchased or in total spending. When limited to beverages, there was a 398 cal reduction (p = 0.01) in the within-category arm and a 438 cal reduction (p < 0.01) in the across-category arm versus the control. Mood and hunger did not modify the effects for either strategy. CONCLUSIONS Results provide evidence that both labelling strategies have the potential to influence food purchasing patterns. However, we cannot definitely state that one labelling approach is superior or even that an increase in the proportion of labelled products purchased will lead to a reduction in calories purchased. TRIAL REGISTRATION The American Economic Association's registry for randomized controlled trials, RCT ID: AEARCTR-0002325; Prospectively Registered October 06, 2017. In compliance with ICMJE policy, the trial was also registered on Clinicaltrials.gov, RCT ID: [NCT04165447]. Retrospectively Registered 11 November 2019.",2020,"Relative to the control condition, there was a 3 percentage point increase (p = 0.01) in labelled products purchased in the within-category arm and a non-significant decrease of 1 percentage point (p = 0.711) in the across-category arm.",['146 participants randomly exposed to'],"['category front-of-package lower-calorie labelling', '1) no labeling control; 2) within-category lower calorie labels, and; 3) across-category lower calorie labels']",['Mood and hunger'],"[{'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}]",146.0,0.209822,"Relative to the control condition, there was a 3 percentage point increase (p = 0.01) in labelled products purchased in the within-category arm and a non-significant decrease of 1 percentage point (p = 0.711) in the across-category arm.","[{'ForeName': 'Eric Andrew', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Felicia Jia Ler', 'Initials': 'FJL', 'LastName': 'Ang', 'Affiliation': 'Programme in Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doble', 'Affiliation': 'Programme in Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}]",BMC public health,['10.1186/s12889-020-8434-1'] 3399,31380605,Hemodialysis without anticoagulation: Less clotting in conventional hemodialysis than in predilution hemodiafiltration.,"INTRODUCTION Hemodialysis patients with contraindication to systemic anticoagulation require a heparin-free hemodialysis technique. Among several alternatives to heparin, predilution hemodiafiltration (HDF) is often used, albeit without any confirmation of its effectiveness. METHODS Patients hospitalized in a nephrology ICU and hemodialysed for stage 5 CKD or AKI and with contraindication to systemic anticoagulation were randomized to either standard HD with a polysulfone membrane, or to predilution HDF with the same membrane. Coagulation activation was evaluated clinically by the need for premature termination and by the measurement of D-dimers. FINDINGS Two hundred dialysis sessions were performed in 155 patients. Survival curves showed better circuit survival in HD (P = 0.046). In HD, 12% of sessions were interrupted for coagulation versus 23% in predilution HDF (P = 0.04). DISCUSSION Predilution HDF was associated with more premature clotting than conventional HD without improvement in dialysis duration or performance epuration indices. When aiming for a 4-hour duration session, conventional heparin-free hemodialysis can be safely proposed in most patients with high bleeding risk.",2019,"DISCUSSION Predilution HDF was associated with more premature clotting than conventional HD without improvement in dialysis duration or performance epuration indices.","['Patients hospitalized in a nephrology ICU and hemodialysed for stage 5 CKD or AKI and with contraindication to systemic anticoagulation', 'patients with high bleeding risk', 'Hemodialysis patients with contraindication to systemic anticoagulation require a']","['standard HD with a polysulfone membrane, or to predilution HDF with the same membrane', 'heparin-free hemodialysis technique', 'Hemodialysis without anticoagulation', 'heparin, predilution hemodiafiltration (HDF']","['Coagulation activation', 'circuit survival in HD', 'dialysis duration or performance epuration indices']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0441777', 'cui_str': 'Stage level 5 (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0137909', 'cui_str': 'polysulfone'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C2960256', 'cui_str': 'Hemodialysis technique (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",200.0,0.0159138,"DISCUSSION Predilution HDF was associated with more premature clotting than conventional HD without improvement in dialysis duration or performance epuration indices.","[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Krummel', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Cellot', 'Affiliation': 'Department of Nephrology, General Hospital of Annecy, Annecy, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Thiery', 'Affiliation': 'Department of Public Health, Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'De Geyer', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Keller', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Hannedouche', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12774'] 3400,30288474,Placebo-Controlled Randomized Trial of an Intestinal Bile Salt Transport Inhibitor for Pruritus in Alagille Syndrome.,"Medically refractory, severe, cholestasis-induced pruritus in Alagille syndrome may be improved by surgical interruption of the enterohepatic circulation. This multicenter trial (NCT02057692) tested the hypothesis that the intestinal bile acid transport inhibitor maralixibat would similarly reduce pruritus in Alagille syndrome. Thirty-seven children with Alagille syndrome were randomly assigned to double-blinded administration of placebo, 70, 140, or 280 µg/kg/day of maralixibat for 13 weeks. Pruritus was assessed by caregiver (itch-reported outcome instrument [ItchRO]) and clinician report (range, 0-4 [severe]). Liver chemistries and serum bile acids were measured. The primary outcome was the change from baseline to week 13 in ItchRO relative to placebo. In the a priori first analysis of the primary efficacy endpoint, the mean adjusted difference between participants receiving 140 or 280 µg/kg/day and placebo was -0.47 (95% confidence interval [CI], -1.14, 0.20; P = 0.16). Statistically significant decreases were observed with doses of 70 and 140 µg/kg/day (mean adjusted difference, -0.89; 95% CI, -1.70, -0.08; P = 0.032; and mean adjusted difference, -0.91; 95% CI, -1.62, -0.19; P = 0.014) but not 280 µg/kg/day (mean adjusted difference, -0.04; 95% CI, -0.94, 0.86; P = 0.44) or all doses combined (mean adjusted difference, -0.61; 95% CI, -1.24, 0.20; P = 0.055). A 1-point reduction in pruritus was more common in maralixibat-treated versus placebo-treated participants (caregiver ItchRO, 65% versus 25%; P = 0.06; clinician score, 76% versus 25%; P = 0.01). There were no significant changes in liver chemistries or bile acids relative to placebo. Adverse and serious adverse events were similar between maralixibat and placebo. Conclusion: Although the prespecified primary analyses of ItchRO were not all statistically significant, the data suggest that maralixibat is safe and may reduce pruritus in Alagille syndrome.",2018,"Statistically significant decreases were observed with doses of 70 and 140 µg/kg/day (mean adjusted difference, -0.89; 95% CI, -1.70, -0.08; P = 0.032; and mean adjusted difference,","['Thirty-seven children with Alagille syndrome', 'Pruritus in Alagille Syndrome']","['Placebo', 'Intestinal Bile Salt Transport Inhibitor', 'placebo']","['Liver chemistries and serum bile acids', 'liver chemistries or bile acids', 'pruritus', 'Adverse and serious adverse events', 'Pruritus']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085280', 'cui_str': 'Arteriohepatic Dysplasia (AHD)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0005404', 'cui_str': 'Bile Salts'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0201682', 'cui_str': 'Chemistry NOS'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.713459,"Statistically significant decreases were observed with doses of 70 and 140 µg/kg/day (mean adjusted difference, -0.89; 95% CI, -1.70, -0.08; P = 0.032; and mean adjusted difference,","[{'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Shneider', 'Affiliation': 'Section of Pediatric Gastroenterology, Hepatology, and Nutrition Baylor College of Medicine Houston TX.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'School of Public Health University of Michigan Ann Arbor MI.'}, {'ForeName': 'Binita M', 'Initials': 'BM', 'LastName': 'Kamath', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Hospital for Sick Children University of Toronto Toronto Canada.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Magee', 'Affiliation': 'University of Michigan Medical School Ann Arbor MI.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Bass', 'Affiliation': ""Pediatrics Division of Gastroenterology, Hepatology, and Nutrition Ann and Robert H. Lurie Children's Hospital of Chicago Chicago IL.""}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Setchell', 'Affiliation': ""Department of Pediatrics-Pathology Cincinnati Children's Hospital Medical Center Cincinnati OH.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Miethke', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology, and Nutrition Cincinnati Children's Hospital Medical Center Cincinnati OH.""}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Molleston', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, and Nutrition Indiana University School of Medicine/Riley Hospital for Children Indianapolis IN.'}, {'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Mack', 'Affiliation': ""Section of Pediatric Gastroenterology, Hepatology, and Nutrition Children's Hospital Colorado Aurora CO.""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Squires', 'Affiliation': ""Children's Hospital of Pittsburgh Pittsburgh PA.""}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Murray', 'Affiliation': ""Division of Gastroenterology and Hepatology University of Washington School of Medicine, Seattle Children's Hospital Seattle WA.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Loomes', 'Affiliation': ""Pediatric Gastroenterology, Hepatology, and Nutrition Children's Hospital of Philadelphia Philadelphia PA.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics University of California San Francisco San Francisco CA.'}, {'ForeName': 'Saul J', 'Initials': 'SJ', 'LastName': 'Karpen', 'Affiliation': ""Pediatric Gastroenterology, Hepatology, and Nutrition Emory University School of Medicine/Children's Healthcare of Atlanta Atlanta GA.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Leung', 'Affiliation': 'Section of Pediatric Gastroenterology, Hepatology, and Nutrition Baylor College of Medicine Houston TX.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Guthery', 'Affiliation': 'Pediatric Gastroenterology, Hepatology, and Nutrition University of Utah Salt Lake City UT.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': ""Department of Gastroenterology Children's Hospital Los Angeles Los Angeles CA.""}, {'ForeName': 'Averell H', 'Initials': 'AH', 'LastName': 'Sherker', 'Affiliation': 'Liver Diseases Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Bethesda MD.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sokol', 'Affiliation': 'Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics University of Colorado School of Medicine Aurora CO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hepatology communications,['10.1002/hep4.1244'] 3401,31399381,"Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial.","BACKGROUND The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care. METHODS We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either the control group or the personalised group using a minimisation algorithm and stratified according to the study site, lung morphology, and duration of mechanical ventilation. Only the patients were masked to allocation. In the control group, patients received a tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP) was selected according to a low PEEP and fraction of inspired oxygen table, and early prone position was encouraged. In the personalised group, the treatment approach was based on lung morphology; patients with focal ARDS received a tidal volume of 8 mL/kg, low PEEP, and prone position. Patients with non-focal ARDS received a tidal volume of 6 mL/kg, along with recruitment manoeuvres and high PEEP. The primary outcome was 90-day mortality as established by intention-to-treat analysis. This study is registered online with ClinicalTrials.gov, NCT02149589. FINDINGS From June 12, 2014, to Feb 2, 2017, 420 patients were randomly assigned to treatment. 11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis. In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98). However, misclassification of patients as having focal or non-focal ARDS by the investigators was observed in 85 (21%) of 400 patients. We found a significant interaction between misclassification and randomised group allocation with respect to the primary outcome (p<0·001). In the subgroup analysis, the 90-day mortality of the misclassified patients was higher in the personalised group (26 [65%] of 40 patients) than in the control group (18 [32%] of 57 patients; HR 2·8; 95% CI 1·5-5·1; p=0·012. INTERPRETATION Personalisation of mechanical ventilation did not decrease mortality in patients with ARDS, possibly because of the misclassification of 21% of patients. A ventilator strategy misaligned with lung morphology substantially increases mortality. Whether improvement in ARDS phenotyping can decrease mortality should be assessed in a future clinical trial. FUNDING French Ministry of Health (Programme Hospitalier de Recherche Clinique InterRégional 2013).",2019,"In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98).","['Patients older than 18 years with early ARDS for less than 12 h', 'patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France', 'patients with acute respiratory distress syndrome (ARDS', '11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis', 'patients with ARDS', 'From June 12, 2014, to Feb 2, 2017, 420 patients', 'Patients with non-focal ARDS', 'patients with acute respiratory distress syndrome in France (the LIVE study']","['personalised mechanical ventilation', 'mechanical ventilation strategy', 'Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure', 'control group or the personalised group using a minimisation algorithm', 'tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP']","['mortality', '90-day mortality', '90-day mortality as established by intention-to-treat analysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",420.0,0.351297,"In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98).","[{'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Constantin', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France; Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France. Electronic address: jmconstantin@chu-clermontferrand.fr.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Jabaudon', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Service des Réanimations, Pôle Anesthésie Douleur Urgences Réanimation, Centre Hospitalier Universitaire de Nîmes, Nîmes, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Montpellier University Hospital, Saint Eloi Intensive Care Unit and PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""Department of Intensive Care, François Mitterrand University Hospital, Dijon, France; Lipness Team, INSERM Research Centre, and LabExLipSTIC, University of Burgundy, Dijon, France; INSERM Centres d'Investigation Clinique, Department of Clinical Epidemiology, University of Burgundy, Dijon, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Langeron', 'Affiliation': 'Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Ferrandière', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Regional University Centre of Tours, Tours, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Grelon', 'Affiliation': 'Service de Réanimation, General Hospital Le Mans, Le Mans, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Seguin', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital of Rennes, University of Rennes 1 and Unité Mixte de Recherche NuMeCan, Rennes, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Ichai', 'Affiliation': ""Intensive Care Unit, University Hospital of Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Veber', 'Affiliation': 'Pôle Anesthésie-Réanimation-SAMU, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'Service de Médicine Intensive et Réanimation, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Uberti', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': 'Department of Anaesthesiology and Reanimation, University Hospital Angers, Angers, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Legay', 'Affiliation': 'Service de Réanimation, Hospital General Saint-Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Leone', 'Affiliation': ""Service d'Anesthésie-Réanimation, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Aix-Marseille Université, Marseille, France.""}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Eisenmann', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Centre Régional de Lutte Contre le Cancer Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': 'Department of Anaesthesia-Intensive Care and Perioperative Medicine, University Hospital of Poitiers, University of Poitiers, INSERM, Poitiers, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Dupont', 'Affiliation': ""Unité de Recherche Clinique Simplification des Soins chez les Patients Complexes, Université Jules Verne de Picardie, Service d'Anesthésie-Réanimation, Centre Hospitalier Universitaire d'Amiens Picardie, Amiens, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Centre Hospitalier Universitaire de Nantes, Hôtel Dieu-HME Hospital, Nantes, France.""}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Sossou', 'Affiliation': 'Service de Réanimation, Centre Hospitalier Général du Puy-en-Velay, Puy-en-Velay, France.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Chanques', 'Affiliation': 'Montpellier University Hospital, Saint Eloi Intensive Care Unit and PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Muller', 'Affiliation': 'Service des Réanimations, Pôle Anesthésie Douleur Urgences Réanimation, Centre Hospitalier Universitaire de Nîmes, Nîmes, France.'}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Monsel', 'Affiliation': 'Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Borao', 'Affiliation': 'Biostatistical Unit, Department of Clinical Research and Innovation, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Garcier', 'Affiliation': 'Department of Radiology, Estaing Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Rouby', 'Affiliation': 'Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistical Unit, Department of Clinical Research and Innovation, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30138-9'] 3402,31371432,"The Impact of Sotagliflozin on Renal Function, Albuminuria, Blood Pressure, and Hematocrit in Adults With Type 1 Diabetes.","OBJECTIVE In people with type 2 diabetes, sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce cardiovascular risk and progression of diabetic kidney disease. Our aim was to determine whether sotagliflozin (SOTA), a dual SGLT1i and SGLT2i, had favorable effects on clinical biomarkers suggestive of kidney protection in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS In this 52-week pooled analysis, 1,575 adults enrolled in the inTandem1 and inTandem2 trials were randomized to SOTA 200 mg, 400 mg, or placebo in addition to optimized insulin therapy. Changes in cardiorenal biomarkers were assessed. RESULTS At 52 weeks, in response to SOTA 200 and 400 mg, the placebo-corrected least squares mean change from baseline in estimated glomerular filtration rate was -2.0 mL/min/1.73 m 2 ( P = 0.010) and -0.5 mL/min/1.73 m 2 ( P = 0.52), respectively. Systolic blood pressure difference was -2.9 and -3.6 mmHg ( P < 0.0001 for both); diastolic blood pressure changed by -1.4 ( P = 0.0033) and -1.6 mmHg ( P = 0.0008). In participants with baseline urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g, UACR decreased by 23.7% ( P = 0.054) and 18.3% ( P = 0.18) for SOTA 200 and SOTA 400 mg, respectively, versus placebo. Increases in serum albumin and hematocrit and reductions in uric acid were observed throughout 52 weeks with both SOTA doses. CONCLUSIONS SOTA was associated with short- and long-term renal hemodynamic changes, which were similar to those seen with SGLT2i in type 2 diabetes. Further investigation around cardiorenal effects of SOTA in people with type 1 diabetes is justified.",2019,Systolic blood pressure difference was -2.9 and -3.6 mmHg ( P < 0.0001 for both); diastolic blood pressure changed by -1.4 ( P = 0.0033) and -1.6 mmHg ( P = 0.0008).,"['adults with type 1 diabetes', 'Adults With Type 1 Diabetes', '1,575 adults enrolled in the inTandem1 and inTandem2 trials', 'people with type 1 diabetes', 'people with type 2 diabetes']","['SOTA', 'Sotagliflozin', 'placebo in addition to optimized insulin therapy', 'placebo', 'sotagliflozin (SOTA', 'sodium-glucose cotransporter 2 inhibitors (SGLT2i']","['glomerular filtration rate', 'UACR', 'diastolic blood pressure', 'Renal Function, Albuminuria, Blood Pressure, and Hematocrit', 'serum albumin and hematocrit and reductions in uric acid', 'Systolic blood pressure difference', 'short- and long-term renal hemodynamic changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3896939'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",1575.0,0.328799,Systolic blood pressure difference was -2.9 and -3.6 mmHg ( P < 0.0001 for both); diastolic blood pressure changed by -1.4 ( P = 0.0033) and -1.6 mmHg ( P = 0.0008).,"[{'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Internal Medicine, Amsterdam UMC, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': 'Division of Nephrology, Department of Medicine, and Section of Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Powell', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'de Cassia Castro', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Ping Stella', 'Initials': 'PS', 'LastName': 'Wang', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, University of Toronto, Toronto, Canada david.cherney@uhn.ca.'}]",Diabetes care,['10.2337/dc19-0937'] 3403,30562322,"The effects of swimming training on arterial function, muscular strength, and cardiorespiratory capacity in postmenopausal women with stage 2 hypertension.","OBJECTIVE Aging is associated with progressive decreases in arterial health as well as muscular strength and cardiorespiratory capacity. It is crucial to prevent or reduce the negative effects of aging on vasculature, muscular, and cardiorespiratory function by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a swimming (SWM) regimen on arterial stiffness (pulse wave velocity [PWV]), blood pressure (BP), wave reflection (augmentation index [AIx]), muscle strength, and aerobic capacity in sedentary, postmenopausal women with stage 2 hypertension. METHODS One hundred participants (∼74 years of age) were recruited from multiple general practice centers. Using a parallel experimental design, participants were randomly assigned to either SWM (n = 52) or nonexercising control group (n = 48) for 20 weeks. Participants in the SWM group trained 3 to 4 days/week. Participants' carotid to radial PWV, BP, AIx, muscular strength, and cardiorespiratory capacity were measured at baseline and after 20 weeks of their assigned intervention. RESULTS There was a significant group × time interaction (P < 0.05) for carotid to radial PWV (Δ-1.2 m/s), AIx (Δ-4%), and systolic (Δ-9 mm Hg) and diastolic BP (Δ - 9 mm Hg), which significantly decreased (P < 0.05); and strength (Δ3 kg) and cardiorespiratory capacity (Δ4 mL/kg/min), which significantly increased (P < 0.05) following SWM compared to no changes in control. CONCLUSIONS SWM led to reductions in arterial stiffness, wave reflection, and BP while increasing strength and aerobic capacity in postmenopausal women with stage 2 hypertension. SWM may be an effective intervention in the prevention and treatment of age-related vascular complications and declines in muscle strength and cardiorespiratory capacity.",2018,SWM may be an effective intervention in the prevention and treatment of age-related vascular complications and declines in muscle strength and cardiorespiratory capacity.,"['postmenopausal women with stage 2 hypertension', 'One hundred participants (∼74 years of age) were recruited from multiple general practice centers', 'sedentary, postmenopausal women with stage 2 hypertension']","['SWM', 'swimming training', 'swimming (SWM) regimen', 'nonexercising control group']","['cardiorespiratory capacity', 'time interaction', 'arterial stiffness, wave reflection, and BP while increasing strength and aerobic capacity', ""Participants' carotid to radial PWV, BP, AIx, muscular strength, and cardiorespiratory capacity"", 'arterial function, muscular strength, and cardiorespiratory capacity', 'arterial stiffness (pulse wave velocity [PWV]), blood pressure (BP), wave reflection (augmentation index [AIx]), muscle strength, and aerobic capacity', 'carotid to radial PWV', 'diastolic BP']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0999177', 'cui_str': 'Genus Aix (organism)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",100.0,0.0818604,SWM may be an effective intervention in the prevention and treatment of age-related vascular complications and declines in muscle strength and cardiorespiratory capacity.,"[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA.'}, {'ForeName': 'Yi-Sub', 'Initials': 'YS', 'LastName': 'Kwak', 'Affiliation': 'Department of Physical Education, Dong-eui University, Busan, Korea.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Scott', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska-Omaha, Omaha, NE.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska-Omaha, Omaha, NE.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'Department of Physical Education, Pusan National University, Busan, Korea.'}, {'ForeName': 'Ji-Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Pusan National University, Busan, Korea.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001288'] 3404,30540657,Hemodynamic effects of the dipeptidyl peptidase-4 inhibitor linagliptin with renin-angiotensin system inhibitors in type 2 diabetic patients with albuminuria.,"OBJECTIVE Concomitant treatment with angiotensin-converting enzyme (ACE) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors is increasingly common. Pharmacological studies have suggested a potential adverse drug interaction between ACE inhibitors and DPP-4 inhibitors resulting in unfavorable hemodynamic changes; very few studies have examined such an interaction between angiotensin II receptor blockers (ARBs) and DPP-4 inhibitors. We investigated blood pressure (BP) and heart rate (HR) during treatment with the DPP-4 inhibitor linagliptin in individuals receiving either ACE inhibitors or ARBs in the MARLINA-T2D trial. METHODS In this study, 360 individuals with type 2 diabetes and albuminuria receiving unchanged doses of ACE inhibitors or ARBs were randomized to linagliptin or placebo. Twenty-four-hour ambulatory BP monitoring, an exploratory endpoint, was conducted at baseline and after 24 weeks. RESULTS Ambulatory BP monitoring data were available for 208 individuals (linagliptin: n = 111; placebo: n = 97). Baseline mean ± SD 24-h SBP and DBP were 132.5 ± 12.4 mmHg and 75.9 ± 9.4 mmHg, respectively; mean 24-h HR was 76.3 ± 10.1 bpm. At week 24, no overall effect of the DPP-4 inhibitor versus placebo was seen on mean 24-h SBP, DBP, or HR. Furthermore, in the subgroups receiving either an ACE inhibitor or an ARB, no effect on these hemodynamic parameters was seen as a result of concomitant DPP-4 inhibitor treatment. CONCLUSION Adding linagliptin to treatment with ACE inhibitors or ARBs was not associated with any hemodynamic changes, supporting their concomitant use in individuals with type 2 diabetes and albuminuria.",2019,"At week 24, no overall effect of the DPP-4 inhibitor versus placebo was seen on mean 24-h SBP, DBP, or HR.","['individuals receiving either ACE inhibitors or ARBs in the MARLINA-T2D trial', 'individuals with type 2 diabetes and albuminuria', 'type 2 diabetic patients with albuminuria', '360 individuals with type 2 diabetes and albuminuria receiving unchanged doses of ACE inhibitors or ARBs', '208 individuals (linagliptin: n\u200a=\u200a111']","['linagliptin', 'DPP-4 inhibitor linagliptin', 'angiotensin-converting enzyme (ACE) inhibitors and dipeptidyl peptidase-4', 'placebo', 'DPP-4 inhibitor versus placebo', 'dipeptidyl peptidase-4 inhibitor linagliptin with renin-angiotensin system inhibitors', 'ACE inhibitors or ARBs', 'ACE inhibitor', 'linagliptin or placebo']","['Baseline mean\u200a±\u200aSD 24-h SBP and DBP', 'Hemodynamic effects', 'mean 24-h SBP, DBP, or HR', 'blood pressure (BP) and heart rate (HR', 'hemodynamic parameters']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl-Peptidase IV'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0035096'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",360.0,0.0320927,"At week 24, no overall effect of the DPP-4 inhibitor versus placebo was seen on mean 24-h SBP, DBP, or HR.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Victoria.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Per-Henrik', 'Initials': 'PH', 'LastName': 'Groop', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Victoria.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Hocher', 'Affiliation': 'Fifth Department of Medicine (Nephrology/Endocrinology/Rheumatology), University Medical Centre Mannheim, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Hehnke', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinicke', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Victoria.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van der Walt', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim.'}]",Journal of hypertension,['10.1097/HJH.0000000000002032'] 3405,32007295,Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.,"OBJECTIVE To investigate whether a dose-response relationship exists between volume of exercise and discontinuation of glucose-lowering medication treatment in patients with type 2 diabetes. PATIENTS AND METHODS Secondary analyses of a randomized controlled exercise-based lifestyle intervention trial (April 29, 2015 to August 17, 2016). Patients with non-insulin-dependent type 2 diabetes were randomly assigned to an intensive lifestyle intervention (U-TURN) or standard-care group. Both groups received lifestyle advice and objective target-driven medical regulation. Additionally, the U-TURN group received supervised exercise and individualized dietary counseling. Of the 98 randomly assigned participants, 92 were included in the analysis (U-TURN, n=61, standard care, n=31). Participants in the U-TURN group were stratified into tertiles based on accumulated volumes of exercise completed during the 1-year intervention. RESULTS Median exercise levels of 178 (interquartile range [IQR], 121-213; lower tertile), 296 (IQR, 261-310; intermediate tertile), and 380 minutes per week (IQR, 355-446; upper tertile) were associated with higher odds of discontinuing treatment with glucose-lowering medication, with corresponding odds ratios of 12.1 (95% CI, 1.2-119; number needed to treat: 4), 30.2 (95% CI, 2.9-318.5; 3), and 34.4 (95% CI, 4.1-290.1; 2), respectively, when comparing with standard care. Cardiovascular risk factors such as glycated hemoglobin A 1c levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group. CONCLUSION Exercise volume is associated with discontinuation of glucose-lowering medication treatment in a dose-dependent manner, as are important cardiovascular risk factors in well-treated participants with type 2 diabetes and disease duration less than 10 years. Further studies are needed to support these findings. STUDY REGISTRATION ClinicalTrials.gov registration (NCT02417012).",2020,"Cardiovascular risk factors such as glycated hemoglobin A 1c levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group. ","['trial (April 29, 2015 to August 17, 2016', 'Patients with non-insulin-dependent type 2 diabetes', '98 randomly assigned participants, 92 were included in the analysis (U-TURN, n=61, standard care, n=31', 'Type 2 Diabetes', 'patients with type 2 diabetes']","['supervised exercise and individualized dietary counseling', 'intensive lifestyle intervention (U-TURN) or standard-care group', 'Exercise', 'glucose-lowering medication treatment', 'controlled exercise-based lifestyle intervention', 'lifestyle advice and objective target-driven medical regulation']","['Cardiovascular risk factors such as glycated hemoglobin A 1c levels, fitness, 2-hour glucose levels, and triglyceride levels', 'Median exercise levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",98.0,0.0908662,"Cardiovascular risk factors such as glycated hemoglobin A 1c levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group. ","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'MacDonald', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; CopenRehab, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. Electronic address: chmd@sund.ku.dk.'}, {'ForeName': 'Mette Y', 'Initials': 'MY', 'LastName': 'Johansen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sabrina M', 'Initials': 'SM', 'LastName': 'Nielsen', 'Affiliation': 'Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Hansen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'CopenRehab, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Allan A', 'Initials': 'AA', 'LastName': 'Vaag', 'Affiliation': 'AstraZeneca, Early Clinical Development, Cardiovascular, Renal and Metabolic Research, Mölndal, Sweden.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Lieberman', 'Affiliation': 'Department of Human Evolutionary Biology, Harvard University, Cambridge, MA.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2019.09.005'] 3406,31510918,Fascia iliaca compartment block as a preoperative analgesic in elderly patients with hip fractures - effects on cognition.,"BACKGROUND Impaired cognition is a major risk factor for perioperative delirium. It is essential to provide good pain control in patients with hip fractures and especially important in patients with severely impaired cognitive status, as they receive less pain medication, have poorer mobility, poorer quality of life and higher mortality than patients with intact cognition. The purpose of this study was to examine the association between preoperative pain management with nerve blocks and cognitive status in patients with hip fractures during the perioperative period. METHODS One hundred and twenty-seven patients with hip fractures participating in a double-blind, randomised, controlled trial were included in this study. At hospital admission, a low-dose fascia iliaca compartment block (FICB) was administered as a supplement to regular analgesia. Cognitive status was registered on arrival at hospital before FICB and on the first postoperative day using the Short Portable Mental Status Questionnaire. RESULTS Changes in cognitive status from arrival at hospital to the first postoperative day showed a positive, albeit not significant, trend in favour of the intervention group. The results also showed that patients with no or a moderate cognitive impairment received 50% more prehospital pain medication than patients with a severe cognitive impairment. FICB was well tolerated in patients with hip fractures. CONCLUSION Fascia iliaca compartment block given to patients with hip fractures did not affect cognitive status in this study. Patients with a cognitive impairment may receive inadequate pain relief after hip fracture and this discrimination needs to be addressed in further studies. TRIAL REGISTRATION EudraCT number 2008-004303-59 date of registration: 2008-10-24.",2019,"RESULTS Changes in cognitive status from arrival at hospital to the first postoperative day showed a positive, albeit not significant, trend in favour of the intervention group.","['Patients with a cognitive impairment', 'elderly patients with hip fractures', 'patients with hip fractures during the perioperative period', 'EudraCT number 2008-004303-59', 'patients with hip fractures', 'One hundred and twenty-seven patients with hip fractures participating']","['Fascia iliaca compartment block', 'FICB']","['prehospital pain medication', 'Cognitive status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",127.0,0.0366262,"RESULTS Changes in cognitive status from arrival at hospital to the first postoperative day showed a positive, albeit not significant, trend in favour of the intervention group.","[{'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Wennberg', 'Affiliation': 'Research and Development Centre, Skaraborg Hospital, Skövde, Sweden. par_wennberg@hotmail.com.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Möller', 'Affiliation': 'University Health Care Research Center, Region Örebro and School of Health and Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Herlitz', 'Affiliation': 'Prehospen-Centre of Prehospital Research; Faculty of Caring Science, Work-Life and Social Welfare, University of Borås, Borås, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kenne Sarenmalm', 'Affiliation': 'Research and Development Centre, Skaraborg Hospital, Skövde, Sweden.'}]",BMC geriatrics,['10.1186/s12877-019-1266-0'] 3407,30118625,A Novel Infant Chest Compression Assist Device Using a Palm Rather Than Fingers: A Randomized Crossover Trial.,"Objective: We developed a novel compression assist device (palm presser) to perform chest compressions using a palm in infant cardiopulmonary resuscitation (CPR). We hypothesized that the palm presser will increase compression depth without increasing hands-off time and will reduce rescuer fatigue compared with the two-finger technique (TFT). Methods: In this randomized crossover manikin trial, participants performed two minutes of CPR with a 30:2 compression:ventilation ratio using the palm presser and the TFT in randomized sequence on an infant manikin. CPR parameters, including compression depth and hands-off time, were collected to compare CPR quality between the palm presser and the TFT. The linear mixed-effect model was used to control the carryover effect of a crossover design in the analysis of CPR parameters. To evaluate rescuer fatigue, we compared changes in compression depth over time and calculated the odds of sufficiently deep compressions over time between the two groups. Results: The palm presser resulted in greater mean compression depth (41.5 ± 1.6 mm vs. 36.8 ± 5.5 mm, p < 0.001), greater sufficiently deep compressions (80.9 ± 27.8% vs. 42.4 ± 35.4%, p < 0.001), and better correct hand position (99.9 ± 0.5% vs. 83.9 ± 25.3%, p = 0.013) than the TFT. Total compressions, compression rate, total ventilations, volume of ventilations, and hands-off time were not significantly different between the two groups. The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024 [95% CI -0.030 to -0.018] vs. -0.004 [95% CI -0.006 to -0.002]). The odds of a compression depth greater than 40 mm increased 2.8 times (95% CI 2.2 to 3.4) with the TFT during the first minute compared with the last minute, whereas the corresponding odds ratio when using the palm presser was not significantly different in the first and last minutes (OR: 1.2 [95% CI 0.9 to 1.5]). Conclusions: Compression with palm pressers resulted in greater compression depth without increasing hands-off time and reduced rescuer fatigue compared with compression with the TFT in simulated infant CPR with manikins.",2019,The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024,['Than Fingers'],"['CPR with a 30:2 compression:ventilation ratio using the palm presser and the TFT', 'novel compression assist device (palm presser) to perform chest compressions using a palm in infant cardiopulmonary resuscitation (CPR', 'TFT']","['odds of a compression depth', 'rescuer fatigue', 'mean change in compression depth over time', 'Total compressions, compression rate, total ventilations, volume of ventilations, and hands-off time', 'compression depth', 'mean compression depth', 'CPR parameters, including compression depth and hands-off time', 'CPR quality']","[{'cui': 'C0016129', 'cui_str': 'Fingers'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0335367', 'cui_str': 'Presser (hand) (occupation)'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0644301,The mean change in compression depth over time was greater with the TFT than with the palm presser (regression coefficient: -0.024,"[{'ForeName': 'Joong Wan', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jae Yun', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Joonghee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Kwak', 'Affiliation': ''}, {'ForeName': 'Do Kyun', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jung Chan', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Eun Mi', 'Initials': 'EM', 'LastName': 'Ham', 'Affiliation': ''}, {'ForeName': 'Soyun', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Hyuksool', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2018.1471559'] 3408,31034106,Differences in long-term physical activity trajectories among individuals with chronic widespread pain: A secondary analysis of a randomized controlled trial.,"BACKGROUND Little is known about long-term physical activity (PA) maintenance in those with chronic widespread pain (CWP) following an exercise intervention. This study examined PA over time to identify the existence and characteristics of subgroups following distinct PA trajectories. METHODS Data come from individuals with CWP who took part in a 2 × 2 factorial randomized controlled trial, receiving either exercise or both exercise and cognitive behavioural therapy treatment. Information, including self-report PA, was collected at baseline recruitment, immediately post-intervention, 3, 24 and 60+ month post-treatment. Analyses were conducted on 196 men and women with ≥ 3 PA data points. Group-based trajectory modelling was used to identify latent PA trajectory groups and baseline characteristics (e.g., demographics, pain, self-rated health, fatigue, coping-strategy use and kinesiophobia) of these groups. RESULTS The best fitting model identified was one with three trajectories: ""non-engagers"" (n = 32), ""maintainers"" (n = 144) and ""super-maintainers"" (n = 20). Overall, mean baseline PA levels were significantly different between groups (non-engagers: 1.1; maintainers: 4.6; super-maintainers: 8.6, p < 0.001) and all other follow-up points. Non-engagers reported, on average, greater BMI, higher disabling chronic pain, poorer self-rated health, physical functioning, as well as greater use of passive coping strategies and lower use of active coping strategies. CONCLUSIONS The majority of individuals with CWP receiving exercise as part of a trial were identified as long-term PA maintainers. Participants with poorer physical health and coping response to symptoms were identified as non-engagers. For optimal symptom management, a stratified approach may enhance initiation and long-term PA maintenance in individuals with CWP. SIGNIFICANCE Chronic pain can be a major barrier to engaging in exercise, a popular self-management strategy. Our findings identify three distinct long-term physical activity trajectories for individuals receiving the same exercise intervention. This suggests an approach by health care providers which identifies individuals who would benefit from additional support to enhance initiation and long-term physical activity maintenance could deliver better outcomes for such patients.",2019,"Overall, mean baseline PA levels were significantly different between groups (non-engagers: 1.1; maintainers: 4.6; super-maintainers: 8.6, p < 0.001) and all other follow-up points.","['individuals with chronic widespread pain', 'individuals with CWP', 'Data come from individuals with CWP who took part in a 2\xa0×\xa02 factorial randomized controlled trial, receiving either', 'Participants with poorer physical health and coping response to symptoms were identified as non-engagers', '196 men and women with\xa0≥\xa03 PA data points']",['exercise or both exercise and cognitive behavioural therapy treatment'],"['BMI, higher disabling chronic pain, poorer self-rated health, physical functioning', 'mean baseline PA levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205391', 'cui_str': 'Widespread (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1565416', 'cui_str': '3-(MTN)PA'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",196.0,0.0921661,"Overall, mean baseline PA levels were significantly different between groups (non-engagers: 1.1; maintainers: 4.6; super-maintainers: 8.6, p < 0.001) and all other follow-up points.","[{'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Martin', 'Affiliation': 'Epidemiology Group, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Druce', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Division of Musculoskeletal & Dermatological Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Murdoch', 'Affiliation': 'Epidemiology Group, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': ""D'Ambruoso"", 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Macfarlane', 'Affiliation': 'Epidemiology Group, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}]","European journal of pain (London, England)",['10.1002/ejp.1410'] 3409,31356810,Use of an Ultrathin vs Thin Bronchoscope for Peripheral Pulmonary Lesions: A Randomized Trial.,"BACKGROUND When evaluating peripheral pulmonary lesions, a 3.0-mm ultrathin bronchoscope (UTB) with a 1.7-mm working channel is advantageous regarding good access to the peripheral airway, whereas a 4.0-mm thin bronchoscope provides a larger 2.0-mm working channel, which allows the use of various instruments including a guide sheath (GS), larger forceps, and an aspiration needle. This study compared multimodal bronchoscopy using a UTB and a thin bronchoscope with multiple sampling methods for the diagnosis of peripheral pulmonary lesions. METHODS Patients with peripheral pulmonary lesions ≤ 30 mm in diameter were recruited and randomized to undergo endobronchial ultrasonography, virtual bronchoscopy, and fluoroscopy-guided bronchoscopy using a 3.0-mm UTB (UTB group) or a 4.0-mm thin bronchoscope (thin bronchoscope group). In the thin bronchoscope group, the use of small forceps with a GS or standard forceps without the GS was permitted. In addition, needle aspiration was performed for lesions into which an ultrasound probe could not be inserted. RESULTS A total of 360 patients were enrolled, and 356 were included in the analyses (median largest lesional diameter, 19 mm). The overall diagnostic yield was significantly higher in the UTB group than in the thin bronchoscope group (70.1% vs 58.7%, respectively; P = .027). The procedure duration was significantly shorter in the UTB group (median, 24.8 vs 26.8 min, respectively; P = .008). The complication rates were 2.8% and 4.5%, respectively (P = .574). CONCLUSIONS Multimodal bronchoscopy using a UTB afforded a higher diagnostic yield than that using a thin bronchoscope in the diagnosis of small peripheral pulmonary lesions. TRIAL REGISTRY UMIN Clinical Trials Registry; No.: UMIN000010133; URL: https://www.umin.ac.jp/ctr/.",2019,"The complication rates were 2.8% and 4.5%, respectively (P = .574). ","['A total of 360 patients were enrolled, and 356 were included in the analyses (median largest lesional diameter, 19\xa0mm', 'Patients with peripheral pulmonary lesions\xa0≤ 30\xa0mm in diameter', 'Peripheral Pulmonary Lesions']","['Ultrathin vs\xa0Thin Bronchoscope', 'endobronchial ultrasonography, virtual bronchoscopy, and fluoroscopy-guided bronchoscopy using a 3.0-mm UTB (UTB group) or a 4.0-mm thin bronchoscope (thin bronchoscope group', 'ultrathin bronchoscope (UTB', 'multimodal bronchoscopy using a UTB and a thin bronchoscope with multiple sampling methods']","['procedure duration', 'complication rates', 'overall diagnostic yield']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0450396', 'cui_str': '30mm (qualifier value)'}]","[{'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscopes'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",360.0,0.0909344,"The complication rates were 2.8% and 4.5%, respectively (P = .574). ","[{'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Oki', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Asano', 'Affiliation': 'Department of Pulmonary Medicine, Gifu Prefectural General Medical Center, Gifu, Japan.'}, {'ForeName': 'Chiyoe', 'Initials': 'C', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Kogure', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Tsuzuku', 'Affiliation': 'Department of Pulmonary Medicine, Gifu Prefectural General Medical Center, Gifu, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan. Electronic address: masahideo@aol.com.'}]",Chest,['10.1016/j.chest.2019.06.038'] 3410,31234240,Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference.,"BACKGROUND A minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double-blind, placebo-controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1-7). OBJECTIVES To estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor-based method. METHODS Data were pooled from three 6-week double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: ""low dose,"" which includes 40 or 50 mg/day; and ""high dose,"" which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine- and placebo-treated) with a Clinical Global Impression of Change-Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved). RESULTS The least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: -2.4; high dose: -3.2; both, P < 0.001) versus placebo (-0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change-Tardive Dyskinesia score ≤3 at week 6 (mean change: -2.2; median change: -2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: -2.0; median change: -2). CONCLUSIONS Results from an anchor-based method indicate that a 2-point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.",2019,The least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose:,"['tardive dyskinesia', 'tardive dyskinesia in adults', 'patients with tardive dyskinesia']","['Valbenazine', 'placebo', 'valbenazine']","['Abnormal Involuntary Movement Scale total score', 'Abnormal involuntary movement scale']","[{'cui': 'C3714760', 'cui_str': 'TD - Tardive dyskinesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4078701', 'cui_str': 'valbenazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0450978', 'cui_str': 'Abnormal Involuntary Movement Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0649393,The least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose:,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stacy', 'Affiliation': 'Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'The Zucker Hillside Hospital, Glen Oaks, New York, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cutler', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Liang', 'Affiliation': 'Neurocrine Biosciences, Inc., San Diego, California, USA.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': ""O'Brien"", 'Affiliation': 'Neurocrine Biosciences, Inc., San Diego, California, USA.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'The Zucker Hillside Hospital, Glen Oaks, New York, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27769'] 3411,30815761,A Randomized Controlled Crossover Study of the Impact of Online Music Training on Pitch and Timbre Perception in Cochlear Implant Users.,"Cochlear implant (CI) biomechanical constraints result in impoverished spectral cues and poor frequency resolution, making it difficult for users to perceive pitch and timbre. There is emerging evidence that music training may improve CI-mediated music perception; however, much of the existing studies involve time-intensive and less readily accessible in-person music training paradigms, without rigorous experimental control paradigms. Online resources for auditory rehabilitation remain an untapped potential resource for CI users. Furthermore, establishing immediate value from an acute music training program may encourage CI users to adhere to post-implantation rehabilitation exercises. In this study, we evaluated the impact of an acute online music training program on pitch discrimination and timbre identification. Via a randomized controlled crossover study design, 20 CI users and 21 normal hearing (NH) adults were assigned to one of two arms. Arm-A underwent 1 month of online self-paced music training (intervention) followed by 1 month of audiobook listening (control). Arm-B underwent 1 month of audiobook listening followed by 1 month of music training. Pitch and timbre sensitivity scores were taken across three visits: (1) baseline, (2) after 1 month of intervention, and (3) after 1 month of control. We found that performance improved in pitch discrimination among CI users and NH listeners, with both online music training and audiobook listening. Music training, however, provided slightly greater benefit for instrument identification than audiobook listening. For both tasks, this improvement appears to be related to both fast stimulus learning as well as procedural learning. In conclusion, auditory training (with either acute participation in an online music training program or audiobook listening) may improve performance on untrained tasks of pitch discrimination and timbre identification. These findings demonstrate a potential role for music training in perceptual auditory appraisal of complex stimuli. Furthermore, this study highlights the importance and the need for more tightly controlled training studies in order to accurately evaluate the impact of rehabilitation training protocols on auditory processing.",2019,"We found that performance improved in pitch discrimination among CI users and NH listeners, with both online music training and audiobook listening.","['20 CI users and 21 normal hearing (NH) adults', 'Cochlear Implant Users']","['Cochlear implant (CI) biomechanical constraints', 'online self-paced music training (intervention) followed by 1\xa0month of audiobook listening (control', 'Music training', 'audiobook listening followed by 1\xa0month of music training', 'auditory training', 'Online Music Training', 'acute online music training program', 'online music training program or audiobook listening', 'music training']","['performance improved in pitch discrimination', 'Pitch and timbre sensitivity scores', 'untrained tasks of pitch discrimination and timbre identification', 'Pitch and Timbre Perception', 'pitch discrimination and timbre identification']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}]","[{'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031996', 'cui_str': 'Pitch Discrimination'}, {'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0468402,"We found that performance improved in pitch discrimination among CI users and NH listeners, with both online music training and audiobook listening.","[{'ForeName': 'Nicole T', 'Initials': 'NT', 'LastName': 'Jiam', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, School of Medicine, University of California - San Francisco (UCSF), 2380 Sutter St, 1st Floor, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Mickael L', 'Initials': 'ML', 'LastName': 'Deroche', 'Affiliation': 'Centre for Research on Brain, Language and Music, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Patpong', 'Initials': 'P', 'LastName': 'Jiradejvong', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, School of Medicine, University of California - San Francisco (UCSF), 2380 Sutter St, 1st Floor, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Limb', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, School of Medicine, University of California - San Francisco (UCSF), 2380 Sutter St, 1st Floor, San Francisco, CA, 94115, USA. charles.limb@ucsf.edu.'}]",Journal of the Association for Research in Otolaryngology : JARO,['10.1007/s10162-018-00704-0'] 3412,31477359,Normal Saline Trigger Point Injections vs Conventional Active Drug Mix for Myofascial Pain Syndromes.,"BACKGROUND Myofascial pain syndrome (MPS) originates in the muscle and fascia. MPS presents with referred pain specific for each muscle and a trigger point that reproduces the symptoms. Trigger-point-injection (TPI) is an effective approach to treating MPS. Some TPI agents, however, are associated with systemic and local side effects. OBJECTIVE The aim of this study was to evaluate the effectiveness of TPI with a conventional active drug mixture (CADM) vs. that with normal saline solution (NS) alone in patients with MPS presenting to the emergency department (ED). METHODS Adults with MPS diagnosed in the ED, participants were randomly assigned to receive TPI with NS or with CADM. Pain intensity was scored using a 0-10 numeric rating scale prior to and after TPI, before discharge and 2 weeks after TPI. RESULTS Among 48 patients analyzed, 23 received TPI with NS. The mean pain scores were as follows: immediately before TPI, 7.59 (NS) and 7.44 (CADM); immediately after TPI, 2.22 (NS) and 1.76 (CADM); prior to discharge, 1.52 (NS) and 1.76 (CADM). At 2-week follow up, the mean pain scores were 4.29 (NS) and 4.14 (CADM). Pain was significantly reduced after TPI in both groups. At 2 weeks, the mean pain scores were similar between the groups. No adverse events were reported. CONCLUSION In cases of MPS in the ED, pain can be controlled with TPI independent of the injectate. TPI with NS may be preferred over CADM because of its lower cost and more favorable side effect profile.",2020,"The mean pain scores were as follows: immediately before TPI, 7.59 (NS) and 7.44 (CADM); immediately after TPI, 2.22 (NS) and 1.76 (CADM); prior to discharge, 1.52 (NS) and 1.76 (CADM).","['patients with MPS presenting to the emergency department (ED', '48 patients analyzed, 23 received TPI with NS', 'patients with myofascial pain syndromes', 'Adults with MPS diagnosed in the ED, participants']","['normal saline (NS) and conventional active drug mix (CADM', 'TPI with a conventional active drug mixture (CADM) vs. that with normal saline solution (NS) alone', 'Trigger-point-injection (TPI', 'MPS', 'TPI with NS or with CADM']","['Pain intensity', 'Pain', 'adverse events', 'mean pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0027073', 'cui_str': 'Myofascial Pain Syndromes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0185340', 'cui_str': 'Injection of trigger points (procedure)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",48.0,0.111465,"The mean pain scores were as follows: immediately before TPI, 7.59 (NS) and 7.44 (CADM); immediately after TPI, 2.22 (NS) and 1.76 (CADM); prior to discharge, 1.52 (NS) and 1.76 (CADM).","[{'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Roldan', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA. Electronic address: croldan@mdanderson.org.'}, {'ForeName': 'Uzondu', 'Initials': 'U', 'LastName': 'Osuagwu', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marylou', 'Initials': 'M', 'LastName': 'Cardenas-Turanzas', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Billy K', 'Initials': 'BK', 'LastName': 'Huh', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158410'] 3413,31553815,Internet-assisted cognitive behavioral intervention for targeted therapy-related fatigue in chronic myeloid leukemia: Results from a pilot randomized trial.,"BACKGROUND Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy. METHODS Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later). RESULTS A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016). CONCLUSIONS CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted.",2020,"More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016). ","['fatigued patients with CML treated with TKIs', 'Patients with CML treated with a TKI who were reporting moderate to severe fatigue', 'chronic myeloid leukemia', '44 patients (mean age, 55\xa0years; 48% female']","['Internet-assisted cognitive behavioral intervention', 'cognitive behavioral intervention', 'WLC', 'cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC', 'CBT-TTF']","['acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome', 'quality of life', 'fatigue and quality of life', 'overall quality of life', 'fatigue']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.136093,"More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016). ","[{'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hyland', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pinilla-Ibarz', 'Affiliation': 'Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Sweet', 'Affiliation': 'Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Gielissen', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Bulls', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Healthcare Delivery Research Program, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}]",Cancer,['10.1002/cncr.32521'] 3414,28944563,A randomized controlled trial of levodopa in patients with Angelman syndrome.,"Treatment for Angelman syndrome (AS) is currently limited to symptomatic interventions. A mouse model of AS has reduced calcium/calmodulin-dependent kinase II activity due to excessive phosphorylation of specific threonine residues, leading to diminished long-term potentiation. In a rat model of Parkinson disease, levodopa reduced phosphorylation of various proteins, including calcium/calmodulin-dependent kinase II. Further studies demonstrated that AS mice treated with levodopa performed better on rotarod testing than untreated AS mice. We conducted a multi-center double-blind randomized placebo-controlled 1-year trial of levodopa / carbidopa with either 10 or 15 mg/kg/day of levodopa in children with AS. The outcome of this intervention was assessed using either the Bayley Scales of Infant Development or the Mullen Scales of Early Learning, as well as the Vineland Adaptive Behavior Scales, and the Aberrant Behavior Checklist. Of the 78 participants enrolled, 67 participants received study medication (33 on levodopa, 34 on placebo), and 55 participants (29 on levodopa, 26 on placebo) completed the 1-year study. There were no clinically or statistically significant changes in any of the outcome measures over a 1-year period comparing the levodopa and placebo groups. The number of adverse events reported, including the more serious adverse events, was similar in both groups, but none were related to treatment with levodopa. Our data demonstrate that levodopa is well-tolerated by children with AS. However, in the doses used in this study, it failed to improve their neurodevelopment or behavioral outcome.",2018,There were no clinically or statistically significant changes in any of the outcome measures over a 1-year period comparing the levodopa and placebo groups.,"['children with AS', 'patients with Angelman syndrome', '78 participants enrolled, 67 participants received study medication (33 on', ' and 55 participants (29 on']","['placebo', 'levodopa / carbidopa', 'levodopa', 'levodopa, 34 on placebo', 'levodopa, 26 on placebo']","['Bayley Scales of Infant Development or the Mullen Scales of Early Learning, as well as the Vineland Adaptive Behavior Scales, and the Aberrant Behavior Checklist', 'number of adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162635', 'cui_str': 'Puppet Children'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}]","[{'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.118552,There were no clinically or statistically significant changes in any of the outcome measures over a 1-year period comparing the levodopa and placebo groups.,"[{'ForeName': 'Wen-Hann', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': ""Division of Genetics and Genomics, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Bird', 'Affiliation': ""Genetics / Dysmorphology, Rady Children's Hospital San Diego; Department of Pediatrics, University of California, San Diego, California.""}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sadhwani', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Rene L', 'Initials': 'RL', 'LastName': 'Barbieri-Welge', 'Affiliation': ""Developmental Services, Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Skinner', 'Affiliation': 'Greenwood Genetic Center, Greenwood, South Carolina.'}, {'ForeName': 'Lucia T', 'Initials': 'LT', 'LastName': 'Horowitz', 'Affiliation': 'Greenwood Genetic Center, Greenwood, South Carolina.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Bacino', 'Affiliation': ""Genetics Service, Texas Children's Hospital; Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Noll', 'Affiliation': ""Psychology Service, Texas Children's Hospital; Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Cary', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Division of Pediatric Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Hundley', 'Affiliation': 'Division of Developmental Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Logan K', 'Initials': 'LK', 'LastName': 'Wink', 'Affiliation': ""Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': ""Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Barnes', 'Affiliation': 'Division of Pediatric Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Slavotinek', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, California.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Jeremy', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rotenberg', 'Affiliation': ""Department of Neurology, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sanjeev V', 'Initials': 'SV', 'LastName': 'Kothare', 'Affiliation': ""Department of Neurology, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Olson', 'Affiliation': ""Department of Neurology, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Annapurna', 'Initials': 'A', 'LastName': 'Poduri', 'Affiliation': ""Department of Neurology, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Nespeca', 'Affiliation': ""Neurology, Rady Children's Hospital San Diego; University of California, San Diego, California.""}, {'ForeName': 'Hillary C', 'Initials': 'HC', 'LastName': 'Chu', 'Affiliation': ""Division of Genetics and Genomics, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Willen', 'Affiliation': ""Division of Genetics and Genomics, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Haas', 'Affiliation': 'Department of Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Edwin J', 'Initials': 'EJ', 'LastName': 'Weeber', 'Affiliation': 'Department of Molecular Pharmacology and Physiology, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Rufo', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital; Harvard Medical School, Boston, Massachusetts.""}]",American journal of medical genetics. Part A,['10.1002/ajmg.a.38457'] 3415,31736225,Difficulty envisioning a positive future: Secondary analyses in patients in intensive care who are communication vulnerable.,"The purpose of this study was to report a secondary analysis of data collected through a primary study. The primary study was a, randomized, control trial that used a team-designed (nursing, speech language hearing, engineering, communication sciences, and biostatistics), nurse-led, electronic communication intervention (Speak for Myself Voice) and measured patient outcomes of symptoms of anxiety and depression in five intensive care units at a regional, magnet-status, academic medical center. A secondary analysis of data using the Hospital Anxiety and Depression scale is reported here. The extant literature supports patient expressions of frustration, anger, anxiety, and depression when unable to communicate. This secondary analysis study report adds information about Hospital Anxiety and Depression subscales in the communication-vulnerable population. Implications include emerging awareness of potential feelings of depression and anxiety in patients who are receiving mechanical ventilation or who are unable to verbally communicate for any reason (e.g. obstruction, trauma, head and neck cancer) in the intensive care unit.",2020,"Implications include emerging awareness of potential feelings of depression and anxiety in patients who are receiving mechanical ventilation or who are unable to verbally communicate for any reason (e.g. obstruction, trauma, head and neck cancer) in the intensive care unit.","['patients who are receiving mechanical ventilation or who are unable to verbally communicate for any reason (e.g. obstruction, trauma, head and neck cancer) in the intensive care unit', 'patients in intensive care who are communication vulnerable']","['team-designed (nursing, speech language hearing, engineering, communication sciences, and biostatistics), nurse-led, electronic communication intervention (Speak for Myself Voice']","['Hospital Anxiety and Depression scale', 'Hospital Anxiety and Depression subscales']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085559'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0014279', 'cui_str': 'Engineerings'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C2717898', 'cui_str': 'Biological Statistics'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0447862,"Implications include emerging awareness of potential feelings of depression and anxiety in patients who are receiving mechanical ventilation or who are unable to verbally communicate for any reason (e.g. obstruction, trauma, head and neck cancer) in the intensive care unit.","[{'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Koszalinski', 'Affiliation': 'College of Nursing, University of Tennessee, Knoxville, Tennessee, USA.'}, {'ForeName': 'R Eric', 'Initials': 'RE', 'LastName': 'Heidel', 'Affiliation': 'Department of Surgery, The University of Tennessee School of Graduate Medicine, Knoxville, Tennessee, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'McCarthy', 'Affiliation': 'Department of Audiology and Speech Pathology, The University of Tennessee Health Science Center, Knoxville, Tennessee, USA.'}]",Nursing & health sciences,['10.1111/nhs.12664'] 3416,30918840,"The effects of canola and olive oils on insulin resistance, inflammation and oxidative stress in women with type 2 diabetes: a randomized and controlled trial.","Background A number of studies have shown that consumption of vegetable oils may improve diabetes complications including inflammatory response and oxidative stress, but no study has been done on the effects of canola oil (CO) and olive oil (OO) consumption in patients with type 2 diabetes. This clinical trial was done to compare the effects of CO and OO on insulin resistance, inflammation and oxidative stress in women with type 2 diabetes. Methods This randomized controlled clinical trial was done on 77 type 2 diabetic women. 4 weeks before the intervention, lipid-lowering drugs intakes were cut under the supervision of an endocrinologist. The participants were randomly divided into 2 intervention groups (Balanced diet +30 g/day CO or OO) and one control group (Balanced diet +30 g/day of sunflower oil (SFO)). Dietary intakes were assessed using three 24-h food records at baseline and at weeks 4 and 8 of the interventions. At baseline and after 8 weeks, height, weight, waist circumference, fasting blood sugar (FBS), serum insulin, C-reactive protein (CRP) and malondialdehyde (MDA) were measured. Results After the intervention in the inter-group analysis, CRP level was reduced significantly in CO and OO groups but no significant changes were observed in other factors. CRP reductions were also significant between all of the groups but not for other factors. Conclusions Replacing CO and OO with SFO as part of daily dietary fat in the diet of people with type 2 diabetes is recommended for reducing Inflammation and Oxidative Stress. Trial registration. This study is approved by the Ethics Committee of Shiraz University of Medical Sciences (IR.SUMS.REC.1394.27) and is recorded in the Iranian Registry of Clinical Trials (IRCT2015062722818N1).",2018,"After the intervention in the inter-group analysis, CRP level was reduced significantly in CO and OO groups but no significant changes were observed in other factors.","['77 type 2 diabetic women', 'women with type 2 diabetes', 'patients with type 2 diabetes']","['canola oil (CO) and olive oil (OO) consumption', 'intervention groups (Balanced diet +30\xa0g/day CO or OO) and one control group (Balanced diet +30\xa0g/day of sunflower oil (SFO', 'CO and OO', 'canola and olive oils', 'lipid-lowering drugs intakes were cut under the supervision of an endocrinologist']","['height, weight, waist circumference, fasting blood sugar (FBS), serum insulin, C-reactive protein (CRP) and malondialdehyde (MDA', 'Dietary intakes', 'CRP level', 'insulin resistance, inflammation and oxidative stress', 'CRP reductions']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0054599', 'cui_str': 'canola oil'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet (finding)'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0086440', 'cui_str': 'Antilipemic Agents'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0259863', 'cui_str': 'Endocrinologists'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.122304,"After the intervention in the inter-group analysis, CRP level was reduced significantly in CO and OO groups but no significant changes were observed in other factors.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Atefi', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Pishdad', 'Affiliation': '2Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Faghih', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-018-0343-9'] 3417,30197271,Tolerability and safety of early enteral nutrition in children after percutaneous endoscopic gastrostomy placement: A multicentre randomised controlled trial.,"BACKGROUND & AIMS We assessed the tolerability and safety of implementing early enteral nutrition in children at 3 h after percutaneous endoscopic gastrostomy (PEG) placement to establish an optimum feeding mode in paediatric patients that reduced the fasting period, the inadequate nutritional support interval, and the hospitalisation time. METHODS Children with clinical indications for PEG placement were recruited from six medical centres in Poland to participate in the study. The patients were centrally randomised to receive the first bolus feed, which comprised a polymeric diet (1 kcal/mL), via a feeding tube at 3 h (group 1) or 8 h (group 2) after PEG placement. The pre-procedural preparation, the post-operative care, and the resumption of feeding were performed on all of the patients in accordance with the study's protocol. The primary endpoint was the number of patients who consumed a full feed, which contained their total fluid and caloric requirements, within 48 h of the first bolus feed. The secondary endpoints were the number of complications and the duration of hospitalisation after PEG placement. RESULTS Of the 97 randomised patients, 49 were assigned to group 1 and 48 were assigned to group 2. There were no differences between the groups regarding feeding tolerability (81.6% vs. 91.6%), the number of complications (25.5% vs. 37.5%), or the duration of hospitalisation after PEG placement (p > 0.05). Full feed post PEG placement was achieved within 24-48 h in most cases (74% vs. 82%). Most of the complications were mild. Two patients in group 2 due to dislocation of the PEG were qualified for laparotomy (at 6 days post-PEG placement in one case and at 14 days post-PEG placement in the other case). One patient in group 2 died at 7 days post-PEG placement; the death was unrelated to the investigation. CONCLUSIONS Introducing feeding at 3 h post-PEG placement in children appears to be well tolerated. The early initiation of post-PEG feeding was not associated with an increase in the number of complications and it had no impact on the duration of hospitalisation. CLINICAL TRIAL REGISTRY: www.clinicaltrials.gov (NCT02777541; registration date: 18/05/2016).",2019,Full feed post PEG placement was achieved within 24-48 h in most cases (74% vs. 82%).,"['97 randomised patients', 'children after percutaneous endoscopic gastrostomy placement', 'children at 3\xa0h after', 'Children with clinical indications for PEG placement were recruited from six medical centres in Poland to participate in the study']","['early enteral nutrition', 'percutaneous endoscopic gastrostomy (PEG) placement']","['tolerated', 'Tolerability and safety', 'death', 'duration of hospitalisation after PEG placement', 'number of patients who consumed a full feed, which contained their total fluid and caloric requirements', 'Full feed post PEG placement', 'tolerability and safety', 'duration of hospitalisation', 'number of complications', 'feeding tolerability', 'number of complications and the duration of hospitalisation after PEG placement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",97.0,0.071339,Full feed post PEG placement was achieved within 24-48 h in most cases (74% vs. 82%).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wiernicka', 'Affiliation': ""Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw, Poland. Electronic address: a.wiernicka@ipczd.pl.""}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Matuszczyk', 'Affiliation': ""Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw, Poland. Electronic address: gosiam86@gmail.com.""}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szlagatys-Sidorkiewicz', 'Affiliation': 'Department of Pediatrics, Gastroenterology, Hepatology and Nutrition, Medical University of Gdańsk, Gdańsk, Poland. Electronic address: aga1@gumed.edu.pl.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Landowski', 'Affiliation': 'Department of Pediatrics, Gastroenterology, Hepatology and Nutrition, Medical University of Gdańsk, Gdańsk, Poland. Electronic address: pland@amg.gda.pl.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Toporowska-Kowalska', 'Affiliation': 'Department of Allergology, Gastroenterology and Nutrition, Medical University, Łódź, Poland. Electronic address: etka@op.pl.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Gębora-Kowalska', 'Affiliation': 'Department of Allergology, Gastroenterology and Nutrition, Medical University, Łódź, Poland. Electronic address: bgkowalska@wp.pl.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Popińska', 'Affiliation': ""Department of Pediatrics, Nutrition and Metabolic Disorders, The Children's Memorial Health Institute, Warsaw, Poland. Electronic address: kasia.popinska@wp.pl.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sibilska', 'Affiliation': ""Department of Pediatrics, Nutrition and Metabolic Disorders, The Children's Memorial Health Institute, Warsaw, Poland. Electronic address: msibilska@poczta.onet.pl.""}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Grzybowska-Chlebowczyk', 'Affiliation': 'Department of Pediatrics, Medical University of Silesia, Katowice, Poland. Electronic address: urszulachlebowczyk@wp.pl.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Więcek', 'Affiliation': 'Department of Pediatrics, Medical University of Silesia, Katowice, Poland. Electronic address: sabinawk@wp.pl.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Hapyn', 'Affiliation': 'Department of Pediatrics and Gastroenterology, Area Hospital in Toruń, Poland. Electronic address: ehapyn@gmail.com.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Blimke-Kozieł', 'Affiliation': 'Department of Pediatrics and Gastroenterology, Area Hospital in Toruń, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Kierkuś', 'Affiliation': ""Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Warsaw, Poland. Electronic address: j.kierkus@ipczd.pl.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.08.018'] 3418,30949906,Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials.,"INTRODUCTION Insulin dosing based on carbohydrate counting is the gold standard for improving glycaemic control in type 1 diabetes (T1D). This post hoc analysis aimed to explore the efficacy and safety of fast-acting insulin aspart (faster aspart) according to bolus dose adjustment method in people with T1D. METHODS Post hoc analysis of two 26-week, treat-to-target, randomised trials investigating treatment with double-blind mealtime faster aspart, insulin aspart (IAsp), or open-label post-meal faster aspart (onset 1, n = 1143; onset 8, n = 1025). Participants with previous experience continued carbohydrate counting (onset 1, n = 669 [58.5%]; onset 8, n = 428 [41.8%]), while remaining participants used a bolus algorithm. RESULTS In onset 1, HbA1c reduction was statistically significantly in favour of mealtime faster aspart versus IAsp with carbohydrate counting (estimated treatment difference [ETD 95% CI] - 0.19% [- 0.30; - 0.09]; - 2.08 mmol/mol [- 3.23; - 0.93]). In onset 8, there was no statistically significant difference in HbA1c reduction with either dose adjustment method, although a trend towards improved HbA1c was observed for mealtime faster aspart with carbohydrate counting (ETD - 0.14% [- 0.28; 0.003]; - 1.53 mmol/mol [- 3.10; 0.04]). In both trials, bolus insulin doses and overall rates of severe or blood glucose-confirmed hypoglycaemia were similar between treatments across dose adjustment methods. CONCLUSION For people with T1D using carbohydrate counting, mealtime faster aspart may offer improved glycaemic control versus IAsp, with similar insulin dose and weight gain and no increased risk of hypoglycaemia. TRIAL REGISTRATION ClinicalTrials.gov: NCT01831765 (onset 1) and NCT02500706 (onset 8). FUNDING Novo Nordisk.",2019,"In both trials, bolus insulin doses and overall rates of severe or blood glucose-confirmed hypoglycaemia were similar between treatments across dose adjustment methods. ","['people with T1D', 'People with Type 1 Diabetes Using Carbohydrate Counting']","['double-blind mealtime faster aspart, insulin aspart (IAsp), or open-label post-meal faster aspart', 'fast-acting insulin aspart (faster aspart', 'carbohydrate counting', 'Fast-Acting Insulin Aspart']","['overall rates of severe or blood glucose-confirmed hypoglycaemia', 'risk of hypoglycaemia', 'HbA1c reduction', 'HbA1c', 'efficacy and safety', 'Efficacy and Safety']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.426106,"In both trials, bolus insulin doses and overall rates of severe or blood glucose-confirmed hypoglycaemia were similar between treatments across dose adjustment methods. ","[{'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': 'Institute of Diabetes Research, Hohenzollernring 70, 48145, Münster, Germany. l.rose@diabetes-muenster.de.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Buchholtz', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gorst-Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive Suite 200, San Diego, CA, 92121, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0608-4'] 3419,31124275,Lobectomy versus stereotactic ablative radiotherapy for medically operable patients with stage IA non-small cell lung cancer: A virtual randomized phase III trial stratified by age.,"BACKGROUND Although the choice between stereotactic ablative radiotherapy (SABR) and lobectomy for early-stage non-small cell lung cancer (NSCLC) has been debated for years, the two procedures have not yet been directly compared in a randomized trial. We conducted a virtual randomized phase III trial stratified by age to compare the effectiveness of lobectomy and SABR for medically operable patients with stage IA (AJCC eighth) NSCLC using the Markov model analysis. METHODS A Markov model was developed to simulate a cohort of patients aged 45-85 years with stage IA NSCLC who had undergone either lobectomy or SABR and were followed up for their remaining lifetime. Each virtual patient was randomly assigned to undergo lobectomy or SABR, and 10 000 patients were allocated to each group. All estimates of the variables were obtained by a systematic review of published articles. RESULTS The lobectomy group showed a better life expectancy than the SABR group, in patients under 75 years of age. However, no statistically significant difference was seen in patients 75 years or older. The predicted life expectancy was 9.43 and 8.70 years in 75-year-old patients in the lobectomy and SABR groups, respectively. However, the 95%CI for the difference in life expectancy between the two groups was - 0.06-1.50 years (P = 0.0689). CONCLUSIONS The Markov model showed no statistically significant difference in the expected overall survival in stage IA NSCLC patients who were older than 75 years and had undergone SABR or lobectomy.",2019,"The lobectomy group showed a better life expectancy than the SABR group, in patients under 75 years of age.","['medically operable patients with stage IA (AJCC eighth', 'medically operable patients with stage IA non-small cell lung cancer', 'patients aged 45-85\u2009years with stage IA NSCLC who had undergone either lobectomy or SABR and were followed up for their remaining lifetime', 'early-stage non-small cell lung cancer (NSCLC', 'stage IA NSCLC patients who were older than 75\u2009years and had undergone SABR or lobectomy', 'patients 75\u2009years or older']","['Lobectomy versus stereotactic ablative radiotherapy', 'lobectomy or SABR', 'lobectomy and SABR', 'stereotactic ablative radiotherapy (SABR) and lobectomy']","['life expectancy', 'overall survival']","[{'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457150', 'cui_str': 'Stage Ia'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",10000.0,0.202948,"The lobectomy group showed a better life expectancy than the SABR group, in patients under 75 years of age.","[{'ForeName': 'Young-Seok', 'Initials': 'YS', 'LastName': 'Seo', 'Affiliation': 'Department of Radiation Oncology, ChungBuk National University Hospital, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Hak Jae', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hong Gyun', 'Initials': 'HG', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Choi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}]",Thoracic cancer,['10.1111/1759-7714.13103'] 3420,30604215,Safety and efficacy of hydroxyethyl starch 6% 130/0.4/9 solution versus 5% human serum albumin in thoracic esophagectomy with 3-field lymph nodes dissection.,"PURPOSE We investigated the safety and efficacy of administering hydroxyethyl starch 6% 130/0.4/9 (HES130/0.4/9) versus 5% human serum albumin (HSA), perioperatively, to patients undergoing thoracic esophagectomy with 3-field lymph-node dissection for esophageal cancer. METHODS The subjects of this study were 262 patients, scheduled to undergo thoracic esophagectomy for esophageal cancer, who were assigned to one of two groups based on the fluid replacement therapy. We compared the intraoperative and immediate postoperative hemodynamics and incidence of complications in the two groups. RESULTS Neither group suffered any adverse events. No significant differences were observed in systolic/diastolic blood pressure, heart rate, incidence of postoperative complications, postoperative urine output, or serum creatinine levels, between the groups. A mild postoperative increase (×1.5 increase) in serum creatinine levels was seen in 9.5% and 9.5% of patients in the HSA and HES130/0.4/9 groups, respectively (p = 0.99), and a moderate postoperative increase (×2.0 increase) was seen in 4.4% and 3.1%, respectively (p = 0.84). Univariate and multivariate analyses revealed that the administration of hydroxyethyl starch was not associated with a postoperative increase in serum creatinine levels. CONCLUSION Hydroxyethyl starch 6% 130/0.4/9 was well tolerated and comparable to albumin with respect to its effect on renal function during thoracic esophagectomy with 3-field lymph-node dissection.",2019,"Univariate and multivariate analyses revealed that the administration of hydroxyethyl starch was not associated with a postoperative increase in serum creatinine levels. ","['thoracic esophagectomy with 3-field lymph nodes dissection', '262 patients, scheduled to undergo thoracic esophagectomy for esophageal cancer']","['Hydroxyethyl starch', 'hydroxyethyl starch', 'thoracic esophagectomy with 3-field lymph-node dissection']","['systolic/diastolic blood pressure, heart rate, incidence of postoperative complications, postoperative urine output, or serum creatinine levels', 'moderate postoperative increase', 'safety and efficacy', 'tolerated', 'serum creatinine levels', 'adverse events', 'renal function', 'Safety and efficacy']","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",262.0,0.0525327,"Univariate and multivariate analyses revealed that the administration of hydroxyethyl starch was not associated with a postoperative increase in serum creatinine levels. ","[{'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. takfujit@east.ncc.go.jp.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Horikiri', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Mayanagi', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kanamori', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Anesthesiology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daiko', 'Affiliation': 'Division of Esophageal Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}]",Surgery today,['10.1007/s00595-018-1752-6'] 3421,30316839,Cerebral blood flow is not modulated following acute aerobic exercise in preadolescent children.,"Cognitive enhancements following a single bout of exercise are frequently attributed to increases in cerebral blood flow, however to date we have little understanding of the extent to which such bouts of exercise actually even influence cerebral blood flow following the cessation of exercise. To gain such insight, both regional and global changes in cerebral blood flow were assessed using 3D pseudo-continuous arterial spin-labeled magnetic resonance imaging in a sample of 41 preadolescent children. Using a within-participants randomized crossover design, cerebral blood flow as assessed prior to and following 20-min of either aerobic exercise or an active-control condition during two separate, counterbalanced sessions. The aerobic exercise condition consisted of walking/jogging on a motor driven treadmill at an intensity of approximately 70% of age-predicted maximum heart rate (HR = 136.1 ± 11.1 bpm). The active control condition consisted of walking on the treadmill at the lowest possible intensity (0.5 mph and 0% grade; HR = 92.0 ± 12.2 bpm). Findings revealed no differences in cerebral blood flow following the cessation of exercise relative to the active control condition. These findings demonstrate that cerebral blood flow may not be altered in preadolescent children following the termination of the exercise stimulus during the period when cognitive enhancements have previously been observed.",2018,Findings revealed no differences in cerebral blood flow following the cessation of exercise relative to the active control condition.,"['preadolescent children', '41 preadolescent children']","['aerobic exercise', '3D pseudo-continuous arterial spin-labeled magnetic resonance imaging', 'aerobic exercise condition consisted of walking/jogging on a motor driven treadmill', 'acute aerobic exercise']","['Cerebral blood flow', 'cerebral blood flow']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0037914', 'cui_str': 'Spin Labels'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",41.0,0.0876356,Findings revealed no differences in cerebral blood flow following the cessation of exercise relative to the active control condition.,"[{'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Pontifex', 'Affiliation': 'Department of Kinesiology, Michigan State University, United States of America. Electronic address: pontifex@msu.edu.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Gwizdala', 'Affiliation': 'Department of Kinesiology, Michigan State University, United States of America.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Weng', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, United States of America.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, Michigan State University, United States of America.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Voss', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2018.10.007'] 3422,31015098,Manual or electroacupuncture as an add-on therapy to SSRIs for depression: A randomized controlled trial.,"Selective serotonin reuptake inhibitors (SSRIs) are first-line antidepressants, however, only around 60% of patients could benefit from them. Acupuncture is supported by insufficient evidence to help with symptom relieving and SSRIs tolerance. This pragmatic randomized controlled trial compared SSRIs alone versus SSRIs together with manual acupuncture (MA) or electroacupuncture (EA) in moderate to severe depressed patients. Patients were randomly allocated to receive MA + SSRIs (161), EA + SSRIs (160), or SSRIs alone (156) for six weeks, and then followed up for another four weeks. The primary outcome was response rate of the 17-item Hamilton Depression Scale (HAMD-17) at 6th week. The secondary outcomes were HAMD-17 (remission rate, early onset rate, total score), Self-Rating Depression Scale (SDS: total score), Clinical Global Impression (CGI), Rating Scale for Side Effects (SERS: total and domain scores), number of patients with adjusted dosage of SSRIs and adverse events (AEs). Both MA + SSRIs and EA + SSRIs were significantly better than SSRIs at 6th week on HAMD-17 response rate (RR = 1.21, 95% CI 1.04, 1.42, P = 0.013; RR = 1.27, 95% CI 1.09, 1.48, P = 0.0014), HAMD-17 early onset rate (P < 0.0001), HAMD-17 and SDS total scores (P < 0.05), CGI (P < 0.01), SERS total score (P < 0.01), number of patients with increased dosage of SSRIs (P < 0.01). For HAMD-17 remission rate, EA + SSRIs was significantly higher than SSRIs (P = 0.0083), while MA + SSRIs showed no significant difference at 6th week (P = 0.092). No unintended acupuncture-related severe AE was observed. This study identified that both MA and EA showed beneficial effects in addition to SSRIs alone in patients with moderate to severe depression, and were well tolerated. Clinical trials registration: ChiCTR-TRC-08000297.",2019,"Both MA + SSRIs and EA + SSRIs were significantly better than SSRIs at 6th week on HAMD-17 response rate (RR = 1.21, 95% CI 1.04, 1.42, P = 0.013; RR = 1.27, 95% CI 1.09, 1.48, P = 0.0014), HAMD-17 early onset rate (P < 0.0001), HAMD-17 and SDS total scores (P < 0.05), CGI (P < 0.01), SERS total score (P < 0.01), number of patients with increased dosage of SSRIs (P ","['moderate to severe depressed patients', 'patients with moderate to severe depression', 'depression']","['Acupuncture', 'SSRIs alone versus SSRIs together with manual acupuncture (MA) or electroacupuncture (EA', 'Manual or electroacupuncture', 'Selective serotonin reuptake inhibitors (SSRIs', 'MA and EA', 'MA\xa0+\xa0SSRIs (161), EA\xa0+\xa0SSRIs (160), or SSRIs alone']","['HAMD-17 early onset rate', 'CGI', 'HAMD-17 response rate', 'tolerated', 'HAMD-17 remission rate, EA\xa0+\xa0SSRIs', 'HAMD-17 (remission rate, early onset rate, total score), Self-Rating Depression Scale (SDS: total score), Clinical Global Impression (CGI), Rating Scale for Side Effects (SERS: total and domain scores), number of patients with adjusted dosage of SSRIs and adverse events (AEs', 'HAMD-17 and SDS total scores', 'severe AE', 'response rate of the 17-item Hamilton Depression Scale (HAMD-17', 'SERS total score', 'number of patients with increased dosage of SSRIs']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0561751,"Both MA + SSRIs and EA + SSRIs were significantly better than SSRIs at 6th week on HAMD-17 response rate (RR = 1.21, 95% CI 1.04, 1.42, P = 0.013; RR = 1.27, 95% CI 1.09, 1.48, P = 0.0014), HAMD-17 early onset rate (P < 0.0001), HAMD-17 and SDS total scores (P < 0.05), CGI (P < 0.01), SERS total score (P < 0.01), number of patients with increased dosage of SSRIs (P ","[{'ForeName': 'Bingcong', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Beijing University of Chinese Medicine, School of Acupuncture-Moxibustion and Tuina, Beijing, 100029, China; Capital Medical University, Beijing Hospital of Traditional Chinese Medicine, Department of Acupuncture and Moxibustion, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, 100010, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Beijing University of Chinese Medicine, School of Acupuncture-Moxibustion and Tuina, Beijing, 100029, China.'}, {'ForeName': 'Yuanzheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': '(c)Peking University First Hospital, Department of Integrative TCM and Western Medicine, Beijing, 100034, China.'}, {'ForeName': 'Xuehong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': '(d)Dongfang Hospital, The Second Clinical Medical College of Beijing University of Chinese Medicine, Department of Acupuncture & Moxibustion, Beijing, 100078, China.'}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': '(e)Peking University Sixth Hospital, Department of Psychiatry, Beijing, 100191, China.'}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, 100191, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Southern Medical University, TCM School, Guangzhou, 510515, China.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Provincial Second Chinese Medicine Hospital, The Acuology Department, Nanjing, 210017, China.'}, {'ForeName': 'Liqin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Sixth Hospital of Baotou, Department of Psychiatry, Baotou, 014060, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'University of Southampton, Aldermoor Health Centre, Primary Care and Population Sciences, Southampton, SO16 5ST, United Kingdom.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Nanjing University of Chinese Medicine, Key Laboratory of Acupuncture and Medicine Research of Minister of Education, Nanjing, 210023, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'Southern Medical University, TCM School, Guangzhou, 510515, China.'}, {'ForeName': 'Qianyun', 'Initials': 'Q', 'LastName': 'Chai', 'Affiliation': 'Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Beijing University of Chinese Medicine, School of Acupuncture-Moxibustion and Tuina, Beijing, 100029, China.'}, {'ForeName': 'Xinjing', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Beijing University of Chinese Medicine, School of Acupuncture-Moxibustion and Tuina, Beijing, 100029, China.'}, {'ForeName': 'Tuya', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': 'Beijing University of Chinese Medicine, School of Acupuncture-Moxibustion and Tuina, Beijing, 100029, China. Electronic address: tuyab@bucm.edu.cn.'}, {'ForeName': 'Yutong', 'Initials': 'Y', 'LastName': 'Fei', 'Affiliation': 'Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, 100029, China. Electronic address: feiyt@bucm.edu.cn.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.005'] 3423,31320747,A head-to-head evaluation of the diagnostic efficacy and costs of trio versus singleton exome sequencing analysis.,"Diagnostic exome sequencing (ES) can be performed on the proband only (singleton; sES) or with additional samples, often including both biological parents with the proband (trio; tES). In this study we sought to compare the efficiencies of exome sequencing (ES) by trio (tES) versus singleton (sES) approach, determine costs, and identify factors to consider when deciding on optimal implementation strategies for the diagnosis of monogenic disorders. We undertook ES in 30 trios and analysed each proband's sES and tES data in parallel. Two teams were randomly allocated to either sES or tES analysis for each case and blinded to each other's work. Each task was timed and cost analyses were based on time taken and diagnostic yield. We modelled three scenarios to determine the factors to consider in the implementation of tES. sES diagnosed 11/30 (36.7%) cases and tES identified one additional diagnosis (12/30 (40.0%)). tES obviated the need for Sanger segregation, reduced the number of variants for curation, and had lower cost-per-diagnosis when considering analysis alone. When sequencing costs were included, tES nearly doubled the cost of sES. Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line. This approach requires a large differential in diagnostic yield between sES and tES for maximal benefit given current sequencing costs. tES may be preferable when scaling up laboratory throughput due to efficiency gains and opportunity cost considerations. Our findings are relevant to clinicians, laboratories and health services considering tES over sES.",2019,Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line.,"[""30 trios and analysed each proband's sES and tES data in parallel""]","['exome sequencing (ES) by trio (tES) versus singleton (sES) approach', 'Diagnostic exome sequencing (ES', 'sES or tES']",[],"[{'cui': 'C0702111', 'cui_str': 'Proband (finding)'}]","[{'cui': 'C3178814', 'cui_str': 'Exome'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",[],,0.0342913,Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line.,"[{'ForeName': 'Tiong Yang', 'Initials': 'TY', 'LastName': 'Tan', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia. tiong.tan@vcgs.org.au.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lunke', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Chong', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Phelan', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Fanjul-Fernandez', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Justine E', 'Initials': 'JE', 'LastName': 'Marum', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Vanessa Siva', 'Initials': 'VS', 'LastName': 'Kumar', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Zornitza', 'Initials': 'Z', 'LastName': 'Stark', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Natasha J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Stutterd', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Delatycki', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sadedin', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Martyn', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Thorne', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Clara L', 'Initials': 'CL', 'LastName': 'Gaff', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'White', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia. sue.white@vcgs.org.au.'}]",European journal of human genetics : EJHG,['10.1038/s41431-019-0471-9'] 3424,30207254,Suicidal ideation and other persisting symptoms after CBT or antidepressant medication treatment for major depressive disorder.,"BACKGROUND Persisting symptoms after treatment for major depressive disorder (MDD) contribute to ongoing impairment and relapse risk. Whether cognitive behavior therapy (CBT) or antidepressant medications result in different profiles of residual symptoms after treatment is largely unknown. METHODS Three hundred fifteen adults with MDD randomized to treatment with either CBT or antidepressant medication in the Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) study were analyzed for the frequency of residual symptoms using the Montgomery Asberg Depression Rating Scale (MADRS) item scores at the end of the 12-week treatment period. Separate comparisons were made for treatment responders and non-responders. RESULTS Among treatment completers (n = 250) who responded to CBT or antidepressant medication, there were no significant differences in the persistence of residual MADRS symptoms. However, non-responders treated with medication were significantly less likely to endorse suicidal ideation (SI) at week 12 compared with those treated with CBT (non-responders to medication: 0/54, 0%, non-responders to CBT: 8/30, 26.7%; p = .001). Among patients who terminated the trial early (n = 65), residual MADRS item scores did not significantly differ between the CBT- and medication-treated groups. CONCLUSIONS Depressed adults who respond to CBT or antidepressant medication have similar residual symptom profiles. Antidepressant medications reduce SI, even among patients for whom the medication provides little overall benefit.",2019,"Among patients who terminated the trial early (n = 65), residual MADRS item scores did not significantly differ between the CBT- and medication-treated groups. ","['major depressive disorder (MDD', 'Three hundred fifteen adults with MDD randomized to treatment with either']","['cognitive behavior therapy (CBT', 'CBT', 'CBT or antidepressant medication']","['residual MADRS item scores', 'endorse suicidal ideation (SI', 'Suicidal ideation', 'persistence of residual MADRS symptoms', 'frequency of residual symptoms using the Montgomery Asberg Depression Rating Scale (MADRS) item scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",315.0,0.0251458,"Among patients who terminated the trial early (n = 65), residual MADRS item scores did not significantly differ between the CBT- and medication-treated groups. ","[{'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences,Emory University School of Medicine,Atlanta, GA,USA.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Polychroniou', 'Affiliation': 'Emory University School of Medicine,Atlanta, GA,USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Rakofsky', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences,Emory University School of Medicine,Atlanta, GA,USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences,University of Miami Miller School of Medicine,Miami, FL,USA.'}, {'ForeName': 'W Edward', 'Initials': 'WE', 'LastName': 'Craighead', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences,Emory University School of Medicine,Atlanta, GA,USA.'}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Mayberg', 'Affiliation': 'Department of Psychiatry,Mount Sinai School of Medicine,New York, NY,USA.'}]",Psychological medicine,['10.1017/S0033291718002568'] 3425,31240312,Discovery and Validation of Banana Intake Biomarkers Using Untargeted Metabolomics in Human Intervention and Cross-sectional Studies.,"BACKGROUND Banana is one of the most widely consumed fruits in the world. However, information regarding its health effects is scarce. Biomarkers of banana intake would allow a more accurate assessment of its consumption in nutrition studies. OBJECTIVES Using an untargeted metabolomics approach, we aimed to identify the banana-derived metabolites present in urine after consumption, including new candidate biomarkers of banana intake. METHODS A randomized controlled study with a crossover design was performed on 12 healthy subjects (6 men, 6 women, mean ± SD age: 30.0 ± 4.9 y; mean ± SD BMI: 22.5 ± 2.3 kg/m2). Subjects underwent 2 dietary interventions: 1) 250 mL control drink (Fresubin 2 kcal fiber, neutral flavor; Fresenius Kabi), and 2) 240 g banana + 150 mL control drink. Twenty-four-hour urine samples were collected and analyzed with ultra-performance liquid chromatography coupled to a quadrupole time-of-flight MS and 2-dimensional GC-MS. The discovered biomarkers were confirmed in a cross-sectional study [KarMeN (Karlsruhe Metabolomics and Nutrition study)] in which 78 subjects (mean BMI: 22.8; mean age: 47 y) were selected reflecting high intake (126-378 g/d), low intake (47.3-94.5 g/d), and nonconsumption of banana. The confirmed biomarkers were examined singly or in combinations, for established criteria of validation for biomarkers of food intake. RESULTS We identified 33 potentially bioactive banana metabolites, of which 5 metabolites, methoxyeugenol glucuronide (MEUG-GLUC), dopamine sulfate (DOP-S), salsolinol sulfate, xanthurenic acid, and 6-hydroxy-1-methyl-1,2,3,4-tetrahydro-β-carboline sulfate, were confirmed as candidate intake biomarkers. We demonstrated that the combination of MEUG-GLUC and DOP-S performed best in predicting banana intake in high (AUCtest = 0.92) and low (AUCtest = 0.87) consumers. The new biomarkers met key criteria establishing their current applicability in nutrition and health research for assessing the occurrence of banana intake. CONCLUSIONS Our metabolomics study in healthy men and women revealed new putative bioactive metabolites of banana and a combined biomarker of intake. These findings will help to better decipher the health effects of banana in future focused studies. This study was registered at clinicaltrials.gov as NCT03581955 and with the Ethical Committee for the Protection of Human Subjects Sud-Est 6 as CPP AU 1251, IDRCB 2016-A0013-48; the KarMeN study was registered with the German Clinical Trials Register (DRKS00004890). Details about the study can be obtained from https://www.drks.de.",2019,"The new biomarkers met key criteria establishing their current applicability in nutrition and health research for assessing the occurrence of banana intake. ","['47 y) were selected reflecting high intake (126-378 g/d), low intake (47.3-94.5 g/d), and nonconsumption of banana', 'mean age', 'healthy men and women', 'Human Subjects Sud-Est 6 as CPP AU 1251, IDRCB 2016-A0013-48', '12 healthy subjects (6 men, 6 women, mean\xa0±', 'SD age: 30.0\xa0±\xa04.9 y', '78 subjects (mean BMI: 22.8']","['2 dietary interventions: 1) 250 mL control drink (Fresubin 2 kcal fiber, neutral flavor; Fresenius Kabi), and 2) 240', '5 metabolites, methoxyeugenol glucuronide (MEUG-GLUC), dopamine sulfate (DOP-S), salsolinol sulfate, xanthurenic acid, and 6-hydroxy-1-methyl-1,2,3,4-tetrahydro-β-carboline sulfate', 'g banana\xa0+\xa0150 mL control drink']",['mean\xa0±'],"[{'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0600510', 'cui_str': 'ESTs'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0208329', 'cui_str': 'Fresubin'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0074002', 'cui_str': 'Salsolinol'}, {'cui': 'C0078610', 'cui_str': '8-hydroxykynurenic acid'}, {'cui': 'C2584674', 'cui_str': 'Carboline (substance)'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",12.0,0.0286401,"The new biomarkers met key criteria establishing their current applicability in nutrition and health research for assessing the occurrence of banana intake. ","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Vázquez-Manjarrez', 'Affiliation': 'Human Nutrition Unit, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Christoph H', 'Initials': 'CH', 'LastName': 'Weinert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Ulaszewska', 'Affiliation': ""Department of Food Quality and Nutrition, Fondazione Edmund Mach, Research and Innovation Centre, San Michele all'Adige, Italy.""}, {'ForeName': 'Carina I', 'Initials': 'CI', 'LastName': 'Mack', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Micheau', 'Affiliation': 'Human Nutrition Unit, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Pétéra', 'Affiliation': ""Human Nutrition Unit, Plateforme d'Exploration du Métabolisme MetaboHUB, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Durand', 'Affiliation': ""Human Nutrition Unit, Plateforme d'Exploration du Métabolisme MetaboHUB, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Pujos-Guillot', 'Affiliation': ""Human Nutrition Unit, Plateforme d'Exploration du Métabolisme MetaboHUB, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Egert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Fondazione Edmund Mach, Research and Innovation Centre, San Michele all'Adige, Italy.""}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Bub', 'Affiliation': 'Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sabine E', 'Initials': 'SE', 'LastName': 'Kulling', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Manach', 'Affiliation': 'Human Nutrition Unit, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.'}]",The Journal of nutrition,['10.1093/jn/nxz125'] 3426,31291447,Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity.,"BACKGROUND Different fatty acids (FAs) can vary in their obesogenic effect, and genetic makeup can contribute to fat deposition in response to dietary FA composition. However, the antiobesogenic effects of the interactions between dietary MUFAs and genetics have scarcely been tested in intervention studies. OBJECTIVE We evaluated the overall (primary outcome) and genetically modulated (secondary outcome) response in body weight and fat mass to different levels of MUFA consumption. METHODS In the Canola Oil Multicenter Intervention Trial II, a randomized, crossover, isocaloric, controlled-feeding multicenter trial, 44 men and 71 women with a mean age of 44 y and an increased waist circumference (men ∼108 cm and women ∼102 cm) consumed each of 3 oils for 6 wk, separated by four 12-wk washout periods. Oils included 2 high-MUFA oils-conventional canola and high-oleic canola (<7% SFAs, >65% MUFAs)-and 1 low-MUFA/high-SFA oil blend (40.2% SFAs, 22.0% MUFAs). Body fat was measured using DXA. Five candidate single-nucleotide polymorphisms (SNPs) were genotyped using qualitative PCR. Data were analyzed using a repeated measures mixed model. RESULTS No significant differences were observed in adiposity measures following the consumption of either high-MUFA diet compared with the low-MUFA/high-SFA treatment. However, when stratified by genotype, 3 SNPs within lipoprotein lipase (LPL), adiponectin, and apoE genes influenced, separately, fat mass changes in response to treatment (n = 101). Mainly, the LPL rs13702-CC genotype was associated with lower visceral fat (high-MUFA: -216.2 ± 58.6 g; low-MUFA: 17.2 ± 81.1 g; P = 0.017) and android fat mass (high-MUFA: -267.3 ± 76.4 g; low-MUFA: -21.7 ± 102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets. CONCLUSIONS Common variants in LPL, adiponectin, and apoE genes modulated body fat mass response to dietary MUFAs in an isocaloric diet in adults with abdominal obesity. These findings might eventually help in developing personalized dietary recommendations for weight control. The trial was registered at clinicaltrials.gov as NCT02029833 (https://www.clinicaltrials.gov/ct2/show/NCT02029833?cond=NCT02029833&rank=1).",2019,"102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets. ","['adults with abdominal obesity', 'Adults with Abdominal Obesity', '44 men and 71 women with a mean age of 44 y and an increased waist circumference (men ∼108 cm and women ∼102 cm']","['MUFA oils-conventional canola and high-oleic canola', 'Dietary Monounsaturated Fatty Acids']","['adiposity measures', 'Body fat', 'body weight and fat mass to different levels of MUFA consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",44.0,0.0925839,"102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets. ","[{'ForeName': 'Shatha S', 'Initials': 'SS', 'LastName': 'Hammad', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eck', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Sihag', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Connelly', 'Affiliation': ""Keenan Research Centre for Biomedical Science of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Lamarche', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Couture', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Guay', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Maltais-Giguère', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Sheila G', 'Initials': 'SG', 'LastName': 'West', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kate J', 'Initials': 'KJ', 'LastName': 'Bowen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'David J A', 'Initials': 'DJA', 'LastName': 'Jenkins', 'Affiliation': ""Keenan Research Centre for Biomedical Science of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Carla G', 'Initials': 'CG', 'LastName': 'Taylor', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Perera', 'Affiliation': 'Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Castillo', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zahradka', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter J H', 'Initials': 'PJH', 'LastName': 'Jones', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz136'] 3427,31876991,Hand and foot exercises for diabetic peripheral neuropathy: A randomized controlled trial.,"Exercises for diabetic peripheral neuropathy remain controversial, especially with regard to recommended precautions and weightbearing exercises for individuals. We aimed to investigate the effect of 8 weeks of simple hand, finger, and foot exercises in patients with diabetic peripheral neuropathy. After randomization, exercise (n = 51) and control (n = 53) groups received usual care and diabetic foot care education; only the exercise group performed exercises. Primary outcomes, including activities of daily living (assessed using the Patient Neurotoxicity Questionnaire), neuropathy severity (monofilament and vibration test), and pain (behavioral rating scale and Visual Analog Scale), and secondary outcomes, including physical function of the hand and foot (grip, pinch, finger counting time, and Timed Up and Go tests), were assessed at baseline, after the 8-week intervention, and at the 16-week follow-up. The exercise group showed significantly stronger improvements in motor score and specific activities of daily living, such as climbing stairs and performing work or chores. Our exercises can be used to improve limb function in patients with diabetic neuropathy.",2020,"The exercise group showed significantly stronger improvements in motor score and specific activities of daily living, such as climbing stairs and performing work or chores.","['patients with diabetic peripheral neuropathy', 'diabetic peripheral neuropathy', 'patients with diabetic neuropathy']","['usual care and diabetic foot care education; only the exercise group performed exercises', 'Hand and foot exercises', 'simple hand, finger, and foot exercises']","['motor score and specific activities of daily living, such as climbing stairs and performing work or chores', 'limb function', 'activities of daily living (assessed using the Patient Neurotoxicity Questionnaire), neuropathy severity (monofilament and vibration test), and pain (behavioral rating scale and Visual Analog Scale), and secondary outcomes, including physical function of the hand and foot (grip, pinch, finger counting time, and Timed Up and Go tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}]","[{'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises (regime/therapy)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1142180', 'cui_str': 'Vibration test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475483', 'cui_str': 'Behavioral Rating Scale'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0418416', 'cui_str': 'Pinched (event)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0228947,"The exercise group showed significantly stronger improvements in motor score and specific activities of daily living, such as climbing stairs and performing work or chores.","[{'ForeName': 'Mi Mi Thet Mon', 'Initials': 'MMTM', 'LastName': 'Win', 'Affiliation': 'Graduate School of Health Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Fukai', 'Affiliation': 'Graduate School of Health Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Htwe Htwe', 'Initials': 'HH', 'LastName': 'Nyunt', 'Affiliation': 'Department of Fundamental Nursing, University of Nursing, Yangon, Myanmar.'}, {'ForeName': 'Khaing Zaw', 'Initials': 'KZ', 'LastName': 'Linn', 'Affiliation': 'Department of Fundamental Nursing, University of Nursing, Yangon, Myanmar.'}]",Nursing & health sciences,['10.1111/nhs.12676'] 3428,31168688,What are the difficulties in conducting randomised controlled trials of thromboprophylaxis in myeloma patients and how can we address these? Lessons from apixaban versus LMWH or aspirin as thromboprophylaxis in newly diagnosed multiple myeloma (TiMM) feasibility clinical trial.,"Routine thromboprophylaxis (TP) in newly-diagnosed multiple myeloma (NDMM) patients comprises either aspirin for standard risk patients or low molecular weight heparin for high risk patients. Studies using DOACs in cancer patients include few with myeloma. The aim of this feasibility clinical trial was to establish the foundations for creating a multicentre trial and identify any safety concerns with apixaban. Patient perspectives were sought. NDMM patients were stratified according to VTE risk and randomised to either standard TP or apixaban 2.5 mg BD and reviewed every 3 weeks throughout their chemotherapy. Two focus groups were carried out on 2 occasions at King's College Hospital and Guy's Hospital, London. Each lasted an hour, were recorded, transcribed and themes explored using NVivo 11. Ten patients were recruited, 2 considered high risk and received apixaban and 8 standard risk; 4 randomised to aspirin and 4 to apixaban. Five patients and 2 carers participated in the focus groups. There were no major bleeding or VTE events. Patients were not aware of the thrombotic risk associated with cancer. There is a lack of both written and verbal information on this topic. Myeloma patients were happy to be included in more than one trial simultaneously. Our study provides information on the difficulties facing physicians and patients on obtaining evidence of the safety of DOACs in the context of myeloma. Despite patients being happy to co-recruit into thromboprophylaxis trials along with chemotherapy trials this is not current practice.EudraCT Number: 2015-002668-18.",2019,There were no major bleeding or VTE events.,"['myeloma patients', 'NDMM patients', 'Five patients and 2 carers participated in the focus groups', 'newly diagnosed multiple myeloma (TiMM', 'for standard risk patients or low molecular weight heparin for high risk patients', ""Two focus groups were carried out on 2 occasions at King's College Hospital and Guy's Hospital, London"", 'newly-diagnosed multiple myeloma (NDMM) patients comprises either', 'cancer patients include few with myeloma', 'Ten patients were recruited, 2 considered high risk and received apixaban and 8 standard risk; 4 randomised to', 'Myeloma patients']","['apixaban', 'Routine thromboprophylaxis (TP', 'aspirin', 'apixaban versus LMWH or aspirin', 'aspirin and 4 to apixaban', 'standard TP or apixaban 2.5\xa0mg BD']","['major bleeding or VTE events', 'thrombotic risk associated with cancer']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3530467', 'cui_str': 'apixaban 2.5 MG [Eliquis]'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",5.0,0.0749219,There were no major bleeding or VTE events.,"[{'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Sayar', 'Affiliation': ""King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK. zara.sayar@nhs.net.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Czuprynska', 'Affiliation': ""King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.""}, {'ForeName': 'Jignesh P', 'Initials': 'JP', 'LastName': 'Patel', 'Affiliation': ""King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.""}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Benjamin', 'Affiliation': ""King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.""}, {'ForeName': 'Lara N', 'Initials': 'LN', 'LastName': 'Roberts', 'Affiliation': ""King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.""}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Patel', 'Affiliation': ""King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'School of Public Health, Imperial College, London, UK.'}, {'ForeName': 'Roopen', 'Initials': 'R', 'LastName': 'Arya', 'Affiliation': ""King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.""}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-019-01891-0'] 3429,31688793,Severity of hemorrhage and the survival benefit associated with plasma: Results from a randomized prehospital plasma trial.,"BACKGROUND Recent randomized clinical trial evidence demonstrated a survival benefit with the use of prehospital plasma in patients at risk of hemorrhagic shock. We sought to characterize the survival benefit associated with prehospital plasma relative to the blood transfusion volume over the initial 24 hours. We hypothesized that the beneficial effects of prehospital plasma would be most robust in those with higher severity of hemorrhage. METHODS We performed a prespecified secondary analysis using data derived from a prospective randomized prehospital plasma trial. Blood component transfusion volumes were recorded over the initial 24 hours. Massive transfusion (MT) was defined a priori as receiving ≥10 units of red cells in 24 hours. We characterized the 30-day survival benefit of prehospital plasma and the need for MT and overall 24-hour red cell transfusion volume utilizing Kaplan-Meier survival analysis and Cox proportional hazard regression. RESULTS There were 501 patients included in this analysis with 230 randomized to prehospital plasma with 104 patients requiring MT. Mortality in patients who received MT were higher compared with those that did not (MT vs. NO-MT, 42% vs. 26%, p = 0.001). Kaplan-Meier survival curves demonstrated early separation in the NO-MT subgroup (log rank p = 0.008) with no survival benefit found in the MT group (log rank p = 0.949). Cox regression analysis verified these findings. When 24-hour red cell transfusion was divided into quartiles, there was a significant independent association with 30-day survival in patients who received 4 to 7 units (hazard ratio, 0.33, 95% confidence interval, 0.14-0.80, p = 0.013). CONCLUSION The survival benefits of prehospital plasma was demonstrated only in patients with red cell requirements below the transfusion level of MT. Patients who received 4 to 7 units of red cells demonstrated the most robust independent survival benefit attributable to prehospital plasma transfusion. Prehospital plasma may be most beneficial in those patients with moderate transfusion requirements and mortality risk. LEVEL OF EVIDENCE Therapeutic, Level I.",2020,"Mortality in patients who received MT were higher compared to those that did not (MT vs. NO-MT, 42% vs 26%, p=0.001).","['501 patients included in this analysis with 230 randomized to prehospital plasma with 104 patients requiring MT', 'patients at risk of hemorrhagic shock']",['Massive transfusion (MT'],"['Mortality', '30-day survival', '30-day survival benefit of prehospital plasma', 'Blood component transfusion volumes', 'survival benefits of prehospital plasma', 'survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}]","[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085430', 'cui_str': 'Blood Component Transfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",501.0,0.481917,"Mortality in patients who received MT were higher compared to those that did not (MT vs. NO-MT, 42% vs 26%, p=0.001).","[{'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Anto', 'Affiliation': 'From the Department of Surgery (V.P.A., J.B., M.N., R.F., B.Z., J.S.), Department of Emergency Medicine (F.X.G.), University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Surgery (B.D.), University of Tennessee Health Science Center, Knoxville; Department of Surgery (R.M.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery, University of Louisville, Louisville (B.H.), Kentucky; Department of Surgery, MetroHealth Medical Center (J.C.), Case Western Reserve University, Cleveland, Ohio; and Department of Surgery (H.P.), University of Texas Southwestern, Parkland Memorial Hospital, Dallas, Texas.'}, {'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Daley', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Herb', 'Initials': 'H', 'LastName': 'Phelan', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Forsythe', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002530'] 3430,31810405,"Short-term Effects of Thoracic Spine Thrust Manipulation, Exercise, and Education in Individuals With Low Back Pain: A Randomized Controlled Trial.","OBJECTIVE To determine the short-term effectiveness of thoracic manipulation when compared to sham manipulation for individuals with low back pain (LBP). DESIGN Randomized controlled trial. METHODS Patients with LBP were stratified based on symptom duration and randomly assigned to a thoracic manipulation or sham manipulation treatment group. Groups received 3 visits that included manipulation or sham manipulation, core stabilization exercises, and patient education. Factorial repeated-measures analysis of variance and multiple regression were performed for pain, disability, and fear avoidance. The Mann-Whitney U test was used to analyze patient-perceived improvement, via the global rating of change scale, at follow-up. RESULTS Ninety participants completed the study (mean ± SD age, 38 ± 11.5 years; 70% female; 72% with chronic LBP). The overall group-by-time interaction was not significant for the Modified Oswestry Disability Questionnaire, numeric pain-rating scale, and Fear-Avoidance Beliefs Questionnaire outcomes. The global rating of change scale was not significantly different between groups. CONCLUSION Three sessions of thoracic manipulation, education, and exercise did not result in improved outcomes when compared to a sham manipulation, education, and exercise in individuals with chronic LBP. Future studies are needed to identify the most effective management strategies for the treatment of LBP. LEVEL OF EVIDENCE Therapy, level 1b. J Orthop Sports Phys Ther 2020;50(1):24-32. Epub 6 Dec 2019. doi:10.2519/jospt.2020.8928 .",2020,"Three sessions of thoracic manipulation, education, and exercise did not result in improved outcomes when compared to a sham manipulation, education, and exercise in individuals with chronic LBP.","['Individuals With Low Back Pain', 'Patients with LBP', 'Ninety participants completed the study (mean ± SD age, 38 ± 11.5 years; 70% female; 72% with chronic LBP', 'individuals with chronic LBP', 'individuals with low back pain (LBP']","['3 visits that included manipulation or sham manipulation, core stabilization exercises, and patient education', 'thoracic manipulation', 'thoracic manipulation or sham manipulation treatment group', 'Thoracic Spine Thrust Manipulation, Exercise, and Education', 'J Orthop Sports']","['Modified Oswestry Disability Questionnaire, numeric pain-rating scale, and Fear-Avoidance Beliefs Questionnaire outcomes', 'pain, disability, and fear avoidance', 'global rating of change scale']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure (body structure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",90.0,0.164608,"Three sessions of thoracic manipulation, education, and exercise did not result in improved outcomes when compared to a sham manipulation, education, and exercise in individuals with chronic LBP.","[{'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Alvar', 'Affiliation': ''}, {'ForeName': 'Sara F', 'Initials': 'SF', 'LastName': 'Maher', 'Affiliation': ''}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.8928'] 3431,31811692,Disentangling the far transfer of language comprehension gains using latent mediation models.,"While we know that interventions targeting oral language can be effective, little is known about what drives these effects. In this study, we examine whether gains in transfer measures are mediated through the specific words that are trained in a language intervention. Based on a large-scale randomized controlled trial of language intervention in 4- to 5-year-old children, latent mediation models were used to disentangle oral language gains in transfer measures. The results first showed that the effects of the language intervention and the transfer effects are generated through expressive rather than receptive measures of language. Second, we found that the effects of the intervention on intermediate transfer measures of language were mediated through the ability to define the trained words. Third, and critically, for far transfer measures that did not contain any of the trained words, the effects were mediated through the trained words. The findings relate to theories of transfer and support the idea that far transfer is possible, at least within the same domain. In addition, it seems that effects on receptive language skills are difficult to obtain and that what is improved is instead the children's ability to express themselves and use procedures to explain words. Thus, to optimize intervention effects, future studies should focus on expressive language.",2020,The results first showed that the effects of the language intervention and the transfer effects are generated through expressive rather than receptive measures of language.,[],['language intervention'],[],[],"[{'cui': 'C0023008', 'cui_str': 'Languages'}]",[],,0.0242686,The results first showed that the effects of the language intervention and the transfer effects are generated through expressive rather than receptive measures of language.,"[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Melby-Lervåg', 'Affiliation': 'Department of Special Needs Education, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Åste Mjelve', 'Initials': 'ÅM', 'LastName': 'Hagen', 'Affiliation': 'Department of Special Needs Education, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lervåg', 'Affiliation': 'Department of Education, University of Oslo, Oslo, Norway.'}]",Developmental science,['10.1111/desc.12929'] 3432,31081480,Do race/ethnicity and religious affiliation moderate treatment outcomes among individuals with co-occurring PTSD and substance use disorders?,"The effect of race/ethnicity and religious affiliation on treatment outcomes among 107 individuals with co-occurring substance use disorder (SUD) and full or subthreshold posttraumatic stress disorder (PTSD) was examined in a secondary analysis. Participants were randomly assigned to one of three treatment conditions: dual-disorder treatment of PTSD and SUD using prolonged exposure; single-disorder relapse prevention treatment for SUD; or an active monitoring control group. Results revealed no significant interaction between race/ethnicity and treatment on PTSD and substance use frequency. However, compared to Whites, African Americans had significantly lower levels of PTSD over the course of treatment. Religious affiliation moderated the impact of treatment on substance use frequency and was a significant predictor of PTSD scores during treatment. Results highlight the need to explore factors associated with social identity variables such as race and religion that may enhance or attenuate the mechanisms of treatments for PTSD and SUD.",2019,Religious affiliation moderated the impact of treatment on substance use frequency and was a significant predictor of PTSD scores during treatment.,"['107 individuals with co-occurring substance use disorder (SUD) and full or subthreshold posttraumatic stress disorder (PTSD', 'individuals with co-occurring PTSD and substance use disorders']",['dual-disorder treatment of PTSD and SUD using prolonged exposure; single-disorder relapse prevention treatment for SUD; or an active monitoring control group'],"['PTSD scores', 'levels of PTSD']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",107.0,0.0141669,Religious affiliation moderated the impact of treatment on substance use frequency and was a significant predictor of PTSD scores during treatment.,"[{'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'a Department of Psychology , The City College of New York , New York , USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Yali', 'Affiliation': 'a Department of Psychology , The City College of New York , New York , USA.'}]",Journal of prevention & intervention in the community,['10.1080/10852352.2019.1603674'] 3433,31769585,"""A Multi-center, randomized, double blinded, comparative study of two hyaluronic acid fillers for temporary restoration of mid-face volume in Asians"".","BACKGROUND There have been few studies using hyaluronic acid fillers to restore mid-face volume deficit especially in Asians. AIMS This study compared the efficacy and safety of two highly cohesive hyaluronic acid fillers, Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine (VYC-20L), for temporary restoration of mid-face volume in Asians. PATIENTS/METHODS A total of 88 subjects with moderate to severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received Neuramis® Volume Lidocaine on one side and VYC-20L on the other side of the face. Response was defined as a ≥1 point reduction in MFVDS at 24 weeks after the injection by photographic assessment. Secondary end points included photographic and live assessments of MFVDS and its changes at week 4, 12, and 24; global aesthetic improvements, as assessed by the investigators and the subjects at each visit; and the proportion of subjects who received touch-up treatment. RESULTS The response rates of the sides treated with Neuramis® Volume Lidocaine and VYC-20L were identical (96.39%) at week 24, demonstrating that Neuramis® Volume Lidocaine was noninferior to VYC-20L. Photographic and live assessments of MFVDS and its changes, global aesthetic improvement, and the proportion of subjects who received touch-up treatment did not differ significantly during follow-up. CONCLUSIONS Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment. Both of these highly cohesive hyaluronic acid fillers can be used effectively and safely for the correction of mid-face volume loss in Asians.",2020,"CONCLUSIONS Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment.","['88 subjects with moderate to severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received', 'temporary restoration of mid-face volume in Asians']","['Lidocaine (VYC-20L', 'Neuramis® Volume Lidocaine', 'cohesive hyaluronic acid fillers, Neuramis® Volume Lidocaine', 'hyaluronic acid fillers', 'Lidocaine']","['photographic and live assessments of MFVDS and its changes at week 4, 12, and 24; global aesthetic improvements', 'efficacy and safety', 'response rates']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",88.0,0.0275443,"CONCLUSIONS Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment.","[{'ForeName': 'Joon Min', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Shun', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Medytox Inc., Seoul, Korea.'}, {'ForeName': 'Hak Tae', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Seon', 'Initials': 'YS', 'LastName': 'Moon', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Hwan', 'Initials': 'SH', 'LastName': 'Paik', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Mi Woo', 'Initials': 'MW', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chong Hyun', 'Initials': 'CH', 'LastName': 'Won', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13218'] 3434,31923472,Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial.,"Despite the burdens costs can place on adults with diabetes, few evidence-based, scalable interventions have been identified that address prevalent health-related financial burdens and unmet social risk factors that serve as major obstacles to effective diabetes management. In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care. We will determine the effectiveness of CareAvenue relative to standard care with respect to improving glycemic control and patient-centered outcomes such as cost-related non-adherence (CRN) behaviors and perceived financial burden. We will also examine the role of patient risk factors (moderators) and behavioral factors (mediators) on the effectiveness of CareAvenue in improving outcomes. We will recruit 720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden. Participants will be randomized to one of two arms: 1) receipt of a 15-20 min web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services. Outcomes will be assessed at baseline and 6- and 12-month follow-up. Clinical Trial Registration: ClinicalTrials.gov ID NCT03950973, May 2019.",2020,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","['720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden', 'adults with diabetes']",['receipt of a 15-20\u202fmin web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services'],['unmet social risk factors and diabetes outcomes'],"[{'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",720.0,0.0729143,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America. Electronic address: minalrp@umich.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; Department of Internal Medicine, Michigan Medicine, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Hae Mi', 'Initials': 'HM', 'LastName': 'Choe', 'Affiliation': 'College of Pharmacy, University of Michigan, United States of America; University of Michigan Medical Group, United States of America.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tobi', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105933'] 3435,31971679,Teprotumumab for the Treatment of Active Thyroid Eye Disease.,"BACKGROUND Thyroid eye disease is a debilitating, disfiguring, and potentially blinding periocular condition for which no Food and Drug Administration-approved medical therapy is available. Strong evidence has implicated the insulin-like growth factor I receptor (IGF-IR) in the pathogenesis of this disease. METHODS In a randomized, double-masked, placebo-controlled, phase 3 multicenter trial, we assigned patients with active thyroid eye disease in a 1:1 ratio to receive intravenous infusions of the IGF-IR inhibitor teprotumumab (10 mg per kilogram of body weight for the first infusion and 20 mg per kilogram for subsequent infusions) or placebo once every 3 weeks for 21 weeks; the last trial visit for this analysis was at week 24. The primary outcome was a proptosis response (a reduction in proptosis of ≥2 mm) at week 24. Prespecified secondary outcomes at week 24 were an overall response (a reduction of ≥2 points in the Clinical Activity Score plus a reduction in proptosis of ≥2 mm), a Clinical Activity Score of 0 or 1 (indicating no or minimal inflammation), the mean change in proptosis across trial visits (from baseline through week 24), a diplopia response (a reduction in diplopia of ≥1 grade), and the mean change in overall score on the Graves' ophthalmopathy-specific quality-of-life (GO-QOL) questionnaire across trial visits (from baseline through week 24; a mean change of ≥6 points is considered clinically meaningful). RESULTS A total of 41 patients were assigned to the teprotumumab group and 42 to the placebo group. At week 24, the percentage of patients with a proptosis response was higher with teprotumumab than with placebo (83% [34 patients] vs. 10% [4 patients], P<0.001), with a number needed to treat of 1.36. All secondary outcomes were significantly better with teprotumumab than with placebo, including overall response (78% of patients [32] vs. 7% [3]), Clinical Activity Score of 0 or 1 (59% [24] vs. 21% [9]), the mean change in proptosis (-2.82 mm vs. -0.54 mm), diplopia response (68% [19 of 28] vs. 29% [8 of 28]), and the mean change in GO-QOL overall score (13.79 points vs. 4.43 points) (P≤0.001 for all). Reductions in extraocular muscle, orbital fat volume, or both were observed in 6 patients in the teprotumumab group who underwent orbital imaging. Most adverse events were mild or moderate in severity; two serious events occurred in the teprotumumab group, of which one (an infusion reaction) led to treatment discontinuation. CONCLUSIONS Among patients with active thyroid eye disease, teprotumumab resulted in better outcomes with respect to proptosis, Clinical Activity Score, diplopia, and quality of life than placebo; serious adverse events were uncommon. (Funded by Horizon Therapeutics; OPTIC ClinicalTrials.gov number, NCT03298867, and EudraCT number, 2017-002763-18.).",2020,"At week 24, the percentage of patients with a proptosis response was higher with teprotumumab than with placebo (83% [34 patients] vs. 10% [4 patients], P<0.001), with a number needed to treat of 1.36.","['patients with active thyroid eye disease', 'patients with active thyroid eye disease in a 1:1 ratio to receive intravenous infusions of the', 'Active Thyroid Eye Disease', '41 patients']","['placebo', 'Teprotumumab', 'IGF-IR inhibitor teprotumumab']","['mean change in GO-QOL overall score', 'overall response (a reduction of ≥2 points in the Clinical Activity Score plus a reduction in proptosis of ≥2 mm), a Clinical Activity Score of 0 or 1 (indicating no or minimal inflammation), the mean change in proptosis across trial visits', 'extraocular muscle, orbital fat volume', 'proptosis, Clinical Activity Score, diplopia, and quality of life', 'proptosis response (a reduction in proptosis of ≥2 mm', 'mean change in proptosis', 'Clinical Activity Score', 'overall response', 'diplopia response', ""mean change in overall score on the Graves' ophthalmopathy-specific quality-of-life (GO-QOL) questionnaire across trial visits"", 'proptosis response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0339143', 'cui_str': 'Graves Ophthalmopathy'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2987429', 'cui_str': 'teprotumumab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015300', 'cui_str': 'Proptosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0028863', 'cui_str': 'Extraocular Muscles'}, {'cui': 'C1285517', 'cui_str': 'Orbital fat'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}, {'cui': 'C0034380'}, {'cui': 'C0339143', 'cui_str': 'Graves Ophthalmopathy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",41.0,0.486477,"At week 24, the percentage of patients with a proptosis response was higher with teprotumumab than with placebo (83% [34 patients] vs. 10% [4 patients], P<0.001), with a number needed to treat of 1.36.","[{'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Douglas', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Kahaly', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Sile', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Elizabeth H Z', 'Initials': 'EHZ', 'LastName': 'Thompson', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Perdok', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fleming', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Fowler', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Marcocci', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Marinò', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Dailey', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Harris', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Eckstein', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Schiffman', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Salvi', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wester', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Sherman', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vescio', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Holt', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': ""From Cedars-Sinai Medical Center, Los Angeles (R.S.D., A.P.); Johannes Gutenberg University Medical Center, Mainz (G.J.K.), and University Hospital Essen, Essen (A.E.) - both in Germany; Horizon Therapeutics, Lake Forest, IL (S.S., E.H.Z.T., R.P., J.W.S., T.V., R.J.H.); University of Tennessee Health Science Center, Memphis (J.C.F., B.T.F.); University of Pisa, Pisa (C.M., M.M., A.A.), and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan (M.S.) - both in Italy; Oregon Health and Sciences University, Portland (R.D.); Medical College of Wisconsin Eye Institute, Milwaukee (G.J.H.); Eye Wellness Center-Neuro-Eye Clinical Trials, Houston (J.S., R.T.); Kellogg Eye Center-Michigan Medicine (C.N., T.J.S.) and University of Michigan Medical School (T.J.S.) - both in Ann Arbor; and Bascom Palmer Eye Institute, Miami (S.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa1910434'] 3436,30714486,A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN).,"BACKGROUND Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. METHODS The primary end point was ""average pain"" after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. RESULTS Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the ""real"" ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the ""real"" group ( P = .14). All ""real"" patients wanted to continue treatment if available. DISCUSSION We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.",2020,"There was improvement in the sensory subscale of the CIPN-20 at 2 months in the ""real"" group ( P = .14).","['patients with cancer with long-lasting disability', 'Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN']","['MC5-A Scrambler Therapy', 'ST', 'Scrambler therapy (ST']","['Numeric Rating Scale', 'Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale', 'average pain', 'Individual responses', 'sensory subscale of the CIPN-20']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",,0.0775898,"There was improvement in the sensory subscale of the CIPN-20 at 2 months in the ""real"" group ( P = .14).","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'A Rab', 'Initials': 'AR', 'LastName': 'Razzak', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ensminger', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Saiki', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Longo-Schoberlein', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic Comprehensive Cancer Center, Rochester, MN, USA.'}]",Journal of palliative care,['10.1177/0825859719827589'] 3437,31924543,Outcomes in Patients with Diabetic Macular Edema Requiring Cataract Surgery in VISTA and VIVID Studies.,"PURPOSE To evaluate the impact of cataract surgery on visual and anatomic outcomes in patients with diabetic macular edema treated with intravitreal aflibercept injection (IAI) or laser control and who did not require rescue therapy. DESIGN Post hoc analysis of 2 phase 3 trials, Study of Intravitreal Aflibercept Injection in Patients with Diabetic Macular Edema (VISTA) and Intravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID). PARTICIPANTS Fifty-four patients (laser treatment, n = 11; IAI, n = 43) who underwent cataract surgery during the study period. METHODS In VISTA and VIVID, patients received IAI 2 mg every 4 weeks, IAI 2 mg every 8 weeks after 5 monthly doses, or laser control through week 100. Starting at week 24, if rescue treatment criteria were met, IAI patients received laser therapy, and laser therapy patients received IAI 2 mg every 8 weeks (after 5 monthly doses). Patients who received rescue treatment before cataract surgery were excluded. MAIN OUTCOME MEASURES Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in the laser control and pooled IAI groups before and after cataract surgery. RESULTS The cumulative incidence of cataract surgery did not depend on treatment group assignment (rate ratio, = 1.517; 95% confidence interval, 0.782-2.944; P = 0.2174). At the last study visit before surgery, BCVA was 62.2 and 56.9 letters and CRT was 342 μm and 301 μm in the laser control and IAI groups, respectively. At the first study visit after cataract surgery, BCVA was improved significantly in both the laser control and IAI groups to 73.5 letters (P = 0.010 compared with last visit before surgery) and 67.2 letters (P < 0.001 compared with last visit before surgery), respectively. Corresponding change in CRT was a modest increase to 364 μm (P > 0.05 compared with last visit before surgery) and 359 μm (P = 0.013 compared with last visit before surgery), respectively. CONCLUSIONS Incidence of cataract surgery was similar in both treatment groups. Despite a modest worsening in CRT after cataract surgery, BCVA was improved in both treatment groups.",2020,"At the first study visit after cataract surgery, BCVA was improved significantly in both the laser control and IAI groups to 73.5 letters (P = 0.010 compared with last visit before surgery) and 67.2 letters (P < 0.001 compared with last visit before surgery), respectively.","['Patients with Diabetic Macular Edema (VISTA) and Intravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID', 'Patients with Diabetic Macular Edema Requiring Cataract Surgery in VISTA and VIVID Studies', 'Fifty-four patients (laser treatment, n\xa0= 11; IAI, n\xa0= 43) who underwent cataract surgery during the study period', 'patients with diabetic macular edema treated with', 'Patients who received rescue treatment before cataract surgery were excluded']","['laser therapy, and laser therapy patients received IAI', 'intravitreal aflibercept injection (IAI) or laser control and who did not require rescue therapy', 'cataract surgery', 'Intravitreal Aflibercept Injection']","['BCVA', 'cumulative incidence of cataract surgery', 'Best-corrected visual acuity (BCVA) and central retinal thickness (CRT', 'visual and anatomic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C1268943', 'cui_str': 'Vivid'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]",54.0,0.052376,"At the first study visit after cataract surgery, BCVA was improved significantly in both the laser control and IAI groups to 73.5 letters (P = 0.010 compared with last visit before surgery) and 67.2 letters (P < 0.001 compared with last visit before surgery), respectively.","[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Moshfeghi', 'Affiliation': 'Department of Ophthalmology, Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: moshfega@med.usc.edu.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Alyson J', 'Initials': 'AJ', 'LastName': 'Berliner', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.10.015'] 3438,31924332,"A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer.","OBJECTIVE This phase 3 study aimed to compare overall survival (OS) of women with platinum-sensitive, recurrent ovarian cancer (ROC) treated with third-line trabectedin (T) + pegylated liposomal doxorubicin (PLD) vs. PLD monotherapy. METHODS Women with advanced-relapsed epithelial ovarian cancer were randomly assigned 1: 1 to intravenous infusions of either T + PLD (trabectedin 1.1 mg/m 2 for 3 h; PLD 30 mg/m 2 for 1.5 h, every 3 weeks) or PLD (50 mg/m 2 for 1.5 h, every 4 weeks). Primary endpoint was OS. Secondary endpoints included investigator-assessed progression free survival (PFS) and objective response rates (ORR). At randomization, patients were stratified by time from last dose of first-line platinum therapy to disease progression, ECOG grade 0 or 1, BRCA1/2 germline mutational status, and prior PLD therapy. Exploratory endpoints included OS, PFS, and ORR in the stratified subgroups (PFI, ECOG, BRCA1/2 status, and prior PLD therapy). This trial is registered with ClinicalTrials.gov, number NCT01846611. RESULTS 576 patients were randomized (T + PLD, n = 289; PLD, n = 287). Median OS was 23.8 months with T + PLD vs. 22.2 months with PLD (HR:0.92, 95%CI:0.73-1.18; p = 0.52). Median PFS was 7.52 vs. 7.26 months (HR:0.93, 95%CI:0.76-1.15; p = 0.52); ORR was 46% vs. 35.9% (OR:1.52, 95%CI:1.07-2.16; p = 0.01). Patients with BRCA1/2 mutations had median OS of 34.2 months with T + PLD vs. 20.9 months with PLD (HR:0.54, 95%CI:0.33-0.90; p = 0.016). Patients with BRCA1/2 mutations had median PFS of 10.1 months with T + PLD vs. 7.6 months with PLD (HR:0.72, 95%CI:0.48-1.08; p = 0.039). Patients with BRCA1/2 mutations and a 6-12 months platinum-free interval (PFI), median OS was 31.5 vs. 14.9 months, respectively (HR:0.37, 95%CI:0.17-0.82; p = 0.011). Grade 3-4 AEs were higher in T + PLD (79%) vs. PLD (54%). CONCLUSION Combination of T and PLD did not show favorable OS benefit nor safety; however, patients with germline BRCA1/2 mutations and/or a PFI of 6-12 months appear to have clinically relevant survival benefit with T + PLD. No new safety signals were identified.",2020,"Median PFS was 7.52 vs. 7.26 months (HR:0.93, 95%CI:0.76-1.15; p = 0.52); ORR was 46% vs. 35.9% (OR:1.52, 95%CI:1.07-2.16; p = 0.01).","['576 patients', 'women with platinum-sensitive, recurrent ovarian cancer (ROC) treated with', 'recurrent ovarian cancer', 'Women with advanced-relapsed epithelial ovarian cancer']","['T\xa0+\xa0PLD (trabectedin 1.1\xa0mg/m 2 for 3\xa0h; PLD 30\xa0mg/m 2 for 1.5\xa0h, every 3\xa0weeks) or PLD', 'third-line trabectedin (T)\xa0+\xa0pegylated liposomal doxorubicin (PLD) vs. PLD monotherapy', 'combined trabectedin and pegylated liposomal doxorubicin therapy']","['platinum-free interval (PFI), median OS', 'Median OS', 'ORR', 'investigator-assessed progression free survival (PFS) and objective response rates (ORR', 'median OS', 'OS, PFS, and ORR in the stratified subgroups (PFI, ECOG, BRCA1/2 status, and prior PLD therapy', 'Median PFS', 'median PFS', 'overall survival (OS', 'OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}]","[{'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",576.0,0.210976,"Median PFS was 7.52 vs. 7.26 months (HR:0.93, 95%CI:0.76-1.15; p = 0.52); ORR was 46% vs. 35.9% (OR:1.52, 95%CI:1.07-2.16; p = 0.01).","[{'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Arizona Oncology (US Oncology Network), Phoenix, AZ, USA; University of Arizona, AZ, USA; Creighton University, USA. Electronic address: Bradley.Monk@usoncology.com.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': 'University of Cincinnati Cancer Institute, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Triantos', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Maul', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Knoblauch', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McGowan', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Waleed S W', 'Initials': 'WSW', 'LastName': 'Shalaby', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.12.043'] 3439,31839083,Comparison of the Effects of Ultrasound-guided Erector Spinae Plane Block and Wound Infiltration on Perioperative Opioid Consumption and Postoperative Pain in Thoracotomy.,"OBJECTIVE To compare the effects of preoperative ultrasound-guided erector spinae plane block (ESPB) and preoperative wound infiltration on perioperative opioid consumption and postoperative pain in thoracotomy. STUDY DESIGN Randomised controlled trial. PLACE AND DURATION OF STUDY Department of Anesthesiology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, from October 2018 to April 2019. METHODOLOGY Sixty adult patients undergoing open esophagectomy were allocated randomly into two groups: experimental group (ultrasound-guided ESPB group, n = 30) and control group (wound infiltration group, n = 30). In ultrasound-guided ESPB group (group EB), ESPB with 20 ml of 0.5% ropivacaine was performed at the level of thoracic 5 transverse process. Whereas, in wound infiltration group (group WI), 20 ml of 0.5% ropivacaine was injected subcutaneously along the marked line of skin incision for surgery and chest tube placement. The perioperative opioid consumption, pain scores at rest and during coughing immediately after surgery, at postoperative day (POD) 1 and POD 2, consumption of rescue analgesic tramadol and postoperative opioid-related adverse events were all assessed. RESULTS Compared with group WI, the intraoperative and postoperative opioid consumptions, postoperative tramadol consumption were significantly less in group EB (p <0.05). Moreover, the postoperative pain scores immediately after surgery, at POD 1 and POD 2, were all lower in group EB compared to group WI (p <0.05). Significantly, the postoperative incidence of nausea and vomiting was lower in group EB than that in group WI (p = 0.021). CONCLUSION Compared to wound infiltration with local anesthetics, preoperative ultrasound-guided ESPB could significantly reduce perioperative opioid consumption, provide a better postoperative analgesia and reduce opioid-related adverse events in thoracotomy.",2019,"Compared with group WI, the intraoperative and postoperative opioid consumptions, postoperative tramadol consumption were significantly less in group","['Sixty adult patients undergoing open esophagectomy', 'Department of Anesthesiology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, from October 2018 to April 2019', 'Thoracotomy']","['experimental group (ultrasound-guided ESPB', 'ropivacaine', 'preoperative ultrasound-guided erector spinae plane block (ESPB) and preoperative wound infiltration', 'ultrasound-guided ESPB', 'Ultrasound-guided Erector Spinae Plane Block and Wound Infiltration']","['perioperative opioid consumption, pain scores', 'postoperative pain scores', 'POD 2, consumption of rescue analgesic tramadol and postoperative opioid-related adverse events', 'intraoperative and postoperative opioid consumptions, postoperative tramadol consumption', 'perioperative opioid consumption', 'EB', 'postoperative incidence of nausea and vomiting', 'Perioperative Opioid Consumption and Postoperative Pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",60.0,0.0206709,"Compared with group WI, the intraoperative and postoperative opioid consumptions, postoperative tramadol consumption were significantly less in group","[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Chaoyang District, Beijing, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Chaoyang District, Beijing, China.'}, {'ForeName': 'Shijing', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Chaoyang District, Beijing, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Chaoyang District, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Chaoyang District, Beijing, China.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2019.12.1138'] 3440,30269898,Effects of protein quantity and type on diet induced thermogenesis in overweight adults: A randomized controlled trial.,"BACKGROUND & AIMS Protein content of a meal is hypothesized to drive DIT dose-dependently. However, no single meal study exists comparing two different doses of protein on DIT. In addition, the source of protein, particularly whey protein, was shown to have a higher DIT than casein and soy in the acute setting, however the mechanism behind this difference is not yet clear. The aim of the present work is therefore to evaluate the efficacy of two different doses and types of protein (whey protein and casein) on DIT in overweight adults. METHODS Randomized, double blind crossover including seventeen overweight men and women assigned to four isocaloric study treatments where protein and carbohydrate were exchanged: control, 30 g of whey protein microgels (WPM30), 50 g WPM (WPM50) or 50 g micellar casein (MC50). Energy expenditure was measured by indirect calorimetry. Blood, breath and urine samples were collected in order to measure substrate oxidation, amino acid profile, glucose and insulin, protein turnover and other metabolic parameters. RESULTS DIT was 6.7 ± 3.7%, 13.0 ± 5.0%, 18.0 ± 5.0% and 16.0 ± 5.0% for control, WPM30, WPM50 and MC50, respectively. There was a significant difference between WPM50 and WPM30 (p < 0.005) and a trend was observed between WPM50 and MC50 (p = 0.06). WPM50 resulted in the highest total, essential, and branched-chain plasma amino acid concentrations when compared with the other study treatments (p < 0.005) and a higher insulin concentration than MC50 (p < 0.005). Protein oxidation was higher for WPM50 than MC50. Protein turnover was significantly correlated with DIT through total leucine oxidation (r = 0.52, p = 0.005). CONCLUSIONS Our findings show that DIT does increase at a dose beyond 30 g of WPM and that the type of dairy protein may have an effect on DIT with WPM tending towards a higher DIT than casein. Although further research is required to understand the mechanism behind the effect of different protein sources on thermogenesis, we suggest that amongst the components of protein turnover, protein oxidation may be an important driver of thermogenesis at doses higher than 30 g. These results have concrete implications when choosing a dose of protein to optimize its thermogenic effect. CLINICAL TRIAL REGISTRY NUMBER NCT02303080 www.clinicaltrials.gov.",2019,There was a significant difference between WPM50 and WPM30 (p < 0.005) and a trend was observed between WPM50 and MC50 (p = 0.06).,"['overweight adults', '50', 'seventeen overweight men and women assigned to four isocaloric study treatments where protein and carbohydrate were exchanged: control']","['g WPM (WPM50) or 50\xa0g micellar casein (MC50', 'WPM50', 'protein (whey protein and casein', 'protein quantity and type']","['Energy expenditure', 'WPM50 and WPM30', 'Blood, breath and urine samples', 'Protein oxidation', 'highest total, essential, and branched-chain plasma amino acid concentrations', 'total leucine oxidation', 'Protein turnover', 'substrate oxidation, amino acid profile, glucose and insulin, protein turnover and other metabolic parameters']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0005768'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",17.0,0.0691206,There was a significant difference between WPM50 and WPM30 (p < 0.005) and a trend was observed between WPM50 and MC50 (p = 0.06).,"[{'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Kassis', 'Affiliation': 'Department of Metabolic Health, Institute of Nutritional Science, Nestlé Research Center, Lausanne, Switzerland. Electronic address: Amira.kassis@rdls.nestle.com.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Godin', 'Affiliation': 'Department of Analytical Science, Institute of Food Safety and Analytical Science, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Moille', 'Affiliation': 'Department of Metabolic Health, Institute of Nutritional Science, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Nielsen-Moennoz', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Groulx', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Sylviane', 'Initials': 'S', 'LastName': 'Oguey-Araymon', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Praplan', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Sauser', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Monnard', 'Affiliation': 'Department of Analytical Science, Institute of Food Safety and Analytical Science, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Anne-France', 'Initials': 'AF', 'LastName': 'Kapp', 'Affiliation': 'Department of Analytical Science, Institute of Food Safety and Analytical Science, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Ammon-Zufferey', 'Affiliation': 'Department of Metabolic Health, Institute of Nutritional Science, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Frei', 'Affiliation': 'Department of Metabolic Health, Institute of Nutritional Science, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Guignard', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Delodder', 'Affiliation': 'Clinical Development Unit, Nestlé Research Center, Lausanne, Switzerland.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Mace', 'Affiliation': 'Department of Metabolic Health, Institute of Nutritional Science, Nestlé Research Center, Lausanne, Switzerland.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.08.004'] 3441,30217471,Between-meal sucrose-sweetened beverage consumption impairs glycaemia and lipid metabolism during prolonged sitting: A randomized controlled trial.,"BACKGROUND & AIMS Chronic overconsumption of sugar-sweetened beverages (SSBs) is associated with unfavourable health effects, including promotion of obesity. However, the acute effects of consuming SSBs on glucose and lipid metabolism remain to be characterized in a real-world, post-prandial context of prolonged sitting. We quantified the acute effects of between-meal SSB consumption compared with water, on glucose and lipid metabolism in habitual soft drink consumers during prolonged sitting. METHODS Twenty-eight overweight or obese young adults [15 males; 23 ± 3 (mean ± SD) years, body mass index (BMI) 31.0 ± 3.6 kg/m 2 ) participated. During uninterrupted sitting and following standardized breakfast and lunch meals, each participant completed two 7-h conditions on separate days in a randomized, crossover design study. For each condition, participants consumed either a sucrose SSB or water mid-morning and mid-afternoon. Peak responses and total area under the curve (tAUC) over 7 h for blood glucose, insulin, C-peptide, triglyceride and non-esterified fatty acid (NEFA) concentrations were quantified and compared. RESULTS Compared to water, SSB consumption significantly increased the peak responses for blood glucose (20 ± 4% (mean ± SEM)), insulin (43 ± 15%) and C-peptide (21 ± 6%) concentrations. The tAUC for all these parameters was also increased by SSB consumption. The tAUC for triglycerides was 15 ± 5% lower after SSBs and this was driven by males (P < 0.05), as females showed no difference between conditions. The tAUC for NEFAs was 13 ± 5% lower after the SSB condition (P < 0.05). CONCLUSIONS Between-meal SSB consumption significantly elevated plasma glucose responses, associated with a sustained elevation in plasma insulin throughout a day of prolonged sitting. The SSB-induced reduction in circulating triglycerides and NEFAs indicates significant modulation of lipid metabolism, particularly in males. These metabolic effects may contribute to the development of metabolic disease when SSB consumption is habitual and co-occurring with prolonged sitting. Clinical Trial Registry number: ACTRN12616000840482, https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12616000840482.",2019,"The tAUC for NEFAs was 13 ± 5% lower after the SSB condition (P < 0.05). ","['overweight or obese young adults [15 males; 23\xa0±\xa03 (mean\xa0±\xa0SD) years, body mass index (BMI) 31.0\xa0±\xa03.6\xa0kg/m 2 ) participated', 'Twenty-eight', 'habitual soft drink consumers during prolonged sitting']","['meal sucrose-sweetened beverage consumption', 'sucrose SSB', 'meal SSB consumption', 'sugar-sweetened beverages (SSBs']","['peak responses for blood glucose', 'plasma glucose responses', 'SSB consumption', 'lipid metabolism', 'Peak responses and total area under the curve (tAUC) over 7\xa0h for blood glucose, insulin, C-peptide, triglyceride and non-esterified fatty acid (NEFA) concentrations', 'glycaemia and lipid metabolism']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C3489624', 'cui_str': 'Soft Drinks'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0823486,"The tAUC for NEFAs was 13 ± 5% lower after the SSB condition (P < 0.05). ","[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Varsamis', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia; Department of Physiology, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia. Electronic address: pia.varsamis@baker.edu.au.'}, {'ForeName': 'Melissa F', 'Initials': 'MF', 'LastName': 'Formosa', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Robyn N', 'Initials': 'RN', 'LastName': 'Larsen', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Medini', 'Initials': 'M', 'LastName': 'Reddy-Luthmoodoo', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Garry L', 'Initials': 'GL', 'LastName': 'Jennings', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia; Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Neale D', 'Initials': 'ND', 'LastName': 'Cohen', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Grace', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia; Department of Physiology, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise & Nutrition Research Programme, Mary MacKillop Institute of Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Devlin', 'Affiliation': 'Exercise & Nutrition Research Programme, Mary MacKillop Institute of Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia; Central Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia; School of Sport Science, Exercise and Health, The University of Western Australia, Perth, Australia; Swinburne University of Technology, Melbourne, Australia; School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia; Central Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia; Centre of Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia; Exercise & Nutrition Research Programme, Mary MacKillop Institute of Health Research, Australian Catholic University, Melbourne, Victoria, Australia; School of Public Health, The University of Queensland, Brisbane, Australia; School of Sport Science, Exercise and Health, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Paddy C', 'Initials': 'PC', 'LastName': 'Dempsey', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia; Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Bronwyn A', 'Initials': 'BA', 'LastName': 'Kingwell', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia; Department of Physiology, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia; Central Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.08.021'] 3442,31707788,Effect of Alirocumab on Stroke in ODYSSEY OUTCOMES.,"BACKGROUND Lowering of atherogenic lipoproteins, including low-density lipoprotein cholesterol (LDL-C), reduces the risk of ischemic stroke. However, concerns have been raised about very low LDL-C levels and a potential increased risk of hemorrhagic stroke. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins, despite intensive statin therapy, targeting LDL-C levels of 25 to 50 mg/dL and avoiding sustained LDL-C <15 mg/dL. This prespecified analysis was designed to assess the effect of alirocumab on ischemic and hemorrhagic stroke. We hypothesized that for patients treated with alirocumab there would be a reduction in risk of ischemic stroke without increasing hemorrhagic stroke, irrespective of baseline LDL-C and of history of cerebrovascular disease. METHODS Patients were randomized to alirocumab or placebo 1 to 12 months after acute coronary syndrome. The risk of nonfatal or fatal ischemic or hemorrhagic stroke was evaluated, stratified by baseline LDL-C concentration and history of cerebrovascular disease. A potential association of very low achieved LDL-C with alirocumab treatment at month 4 and subsequent hemorrhagic stroke was assessed. RESULTS Median follow-up was 2.8 years. In total, 263 ischemic and 33 hemorrhagic strokes occurred. Alirocumab reduced the risk of any stroke (HR, 0.72 [95% CI, 0.57-0.91]) and ischemic stroke (HR, 0.73 [95% CI, 0.57-0.93]) without increasing hemorrhagic stroke (HR, 0.83 [95% CI, 0.42-1.65]). In total, 7164 (37.9%), 6128 (32.4%), and 5629 (29.7%) patients had a baseline LDL-C of <80, 80 to 100, and >100 mg/dL, respectively. The treatment effect on stroke appeared numerically greater for patients with higher baseline LDL-C, but there was no formal evidence of heterogeneity ( P interaction =0.31). The effect of alirocumab on stroke was similar among 944 patients (5.0%) with a history of previous cerebrovascular disease and among those without a history of cerebrovascular disease ( P interaction =0.37). There was no apparent adverse relation between lower achieved LDL-C and incidence of hemorrhagic stroke in the alirocumab group. CONCLUSIONS In patients with recent acute coronary syndrome and dyslipidemia despite intensive statin therapy, alirocumab decreased the risk of stroke, irrespective of baseline LDL-C and history of cerebrovascular disease, over a median follow-up of 2.8 years. Furthermore, risk of hemorrhagic stroke did not depend on achieved LDL-C levels within the alirocumab group. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402.",2019,"There was no apparent adverse relation between lower achieved LDL-C and incidence of hemorrhagic stroke in the alirocumab group. ","['patients with recent acute coronary syndrome and dyslipidemia despite intensive statin therapy', '18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins', '944 patients (5.0%) with a history of previous cerebrovascular disease and among those without a history of cerebrovascular disease ( P interaction =0.37', 'Patients']","['Alirocumab', 'alirocumab', 'placebo', 'alirocumab or placebo']","['stroke', 'risk of any stroke', 'risk of ischemic stroke', 'LDL-C levels', 'ischemic stroke', 'hemorrhagic stroke', 'risk of stroke, irrespective of baseline LDL-C and history of cerebrovascular disease', 'risk of nonfatal or fatal ischemic or hemorrhagic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0007820', 'cui_str': 'Intracranial Vascular Disorders'}, {'cui': 'C0585890', 'cui_str': 'History of cerebrovascular disease'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C4517454', 'cui_str': '0.37'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0585890', 'cui_str': 'History of cerebrovascular disease'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]",944.0,0.370384,"There was no apparent adverse relation between lower achieved LDL-C and incidence of hemorrhagic stroke in the alirocumab group. ","[{'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, The Netherlands (J.W.J., L.E.Z.).'}, {'ForeName': 'Laurien E', 'Initials': 'LE', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, The Netherlands (J.W.J., L.E.Z.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts (D.L.B.).""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham (V.A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.).'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Drexel', 'Affiliation': 'Landeskrankenhaus Feldkirch, Austria (H.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'Sanofi, Paris, France (Y-U.K.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York (R.P.).'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Reiner', 'Affiliation': 'University Hospital Center Zagreb, School of Medicine, University of Zagreb, Croatia (Z.R.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina (M.T.R.).'}, {'ForeName': 'Hung-Fat', 'Initials': 'HF', 'LastName': 'Tse', 'Affiliation': 'Queen Mary Hospital, The University of Hong Kong (H-F.T.).'}, {'ForeName': 'Pablo Carlos', 'Initials': 'PC', 'LastName': 'Montenegro Valdovinos', 'Affiliation': 'Unidad de Diagnostico Cardiologico, Guatemala City, Guatemala (P.C.M.V.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand (H.D.W.).'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany (A.M.Z.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora (G.G.S.).'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris (P.G.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.043826'] 3443,31985275,Positional Changes in Arterial Oxygen Saturation and End-Tidal Carbon Dioxide at High Altitude: Medex 2015.,"Background: Body position alters aspects of pulmonary function in health and disease. Although studies have assessed positional effects on the heart and lungs, little is known about positional changes in gas exchange parameters at high altitude. We hypothesized that following ascent, supine positioning would cause lower oxygen saturation than sitting, partially due to decreased ventilation and increased partial pressure of end-tidal carbon dioxide (Petco 2 ). Materials and Methods: Twenty-eight healthy subjects were studied at sea level and following gradual ascent to 5150 m. After 10 minutes of sitting rest, subjects were studied for 5 minutes each in the sitting, supine, and prone positions with the order randomly assigned. Pulse oximeter oxygen saturation (SpO 2 ), minute ventilation (V E ), end-tidal O 2 (Peto 2 ) and Petco 2 , oxygen consumption, and CO 2 production were continuously measured. Alveolar ventilation (V A ) was calculated from the measured parameters. Results: At high altitude, V E was not affected by body position (12.96 ± 3.09 and 11.54 ± 3.45 L/min in the sitting and supine positions, respectively, p  = 0.255). Petco 2 increased from sitting to supine (22.8 ± 3.1 to 23.5 ± 3.3 mm Hg, p  < 0.005), but V E and Petco 2 were not different between the supine and prone positions. Calculated V A was not significantly affected by body position at either sea level or high altitude. SpO 2 decreased from 81.3% ± 4.4% sitting to 78.8% ± 6.0% supine ( p  = 0.025), with a mean positional SpO 2 difference of 2.5% ± 4.9% (95% confidence interval 0.6%-4.4%). SpO 2 was not different between the supine and prone positions. Twenty-two of 28 subjects had lower SpO 2 supine compared with sitting. Conclusions: These results extend earlier low-altitude studies and demonstrate the importance of postural regulation in different environments. As 79% of subjects had lower SpO 2 while supine than sitting, control of body position is necessary for SpO 2 comparisons at altitude to be meaningful.",2020,"SpO 2 decreased from 81.3% ± 4.4% sitting to 78.8% ± 6.0% supine ( p  = 0.025), with a mean positional SpO 2 difference of 2.5% ± 4.9% (95% confidence interval 0.6%-4.4%).","['Twenty-eight healthy subjects were studied at sea level and following gradual ascent to 5150\u2009m', 'pulmonary function in health and disease']",[],"['Alveolar ventilation (V A ', 'Petco 2 increased from sitting to supine', 'Pulse oximeter oxygen saturation (SpO 2 ), minute ventilation (V E ), end-tidal O 2 (Peto 2 ) and Petco 2 , oxygen consumption, and CO 2 production', 'Arterial Oxygen Saturation and End-Tidal Carbon Dioxide at High Altitude', 'partial pressure of end-tidal carbon dioxide (Petco 2 ', 'SpO 2']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V), function (observable entity)'}, {'cui': 'C0231966', 'cui_str': 'Alveolar gas volume, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter (physical object)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0231963', 'cui_str': 'Volume of expired gas (observable entity)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0033268'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}]",28.0,0.0256855,"SpO 2 decreased from 81.3% ± 4.4% sitting to 78.8% ± 6.0% supine ( p  = 0.025), with a mean positional SpO 2 difference of 2.5% ± 4.9% (95% confidence interval 0.6%-4.4%).","[{'ForeName': 'Arlena', 'Initials': 'A', 'LastName': 'Kuenzel', 'Affiliation': 'Department of Anaesthesia, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, Scotland.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Marshall', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': 'INSERM U1042 and HP2 Laboratory, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Anholm', 'Affiliation': 'Division of Pulmonary, Critical Care, Hyperbaric and Sleep Medicine, Department of Medicine, Loma Linda University School of Medicine, Loma Linda, California, USA.'}]",High altitude medicine & biology,['10.1089/ham.2019.0066']